OxyNorm 50 mg / ml, solution for injection or infusion

OxyNorm 50 mg/ml, solution for injection or infusion

Oxycodone hydrochloride

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
  if their symptoms are the same as yours.


• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What OxyNorm injection is and what it is used for

2. Before you use OxyNorm injection

3. How to use OxyNorm injection

4. Possible side effects

5. How to store OxyNorm injection

6. Further information

What OxyNorm injection is and what it is used for

This injection has been prescribed for you by your doctor to relieve moderate to severe pain. It contains the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers’. The other ingredients are listed in section 6 of this leaflet.

Before you use OxyNorm injection

Do not use OxyNorm injection:

• if you are allergic (hypersensitive) to oxycodone, or any of the other ingredients of OxyNorm injection;


• if you have breathing problems, such as respiratory depression, chronic obstructive airways disease, chronic bronchial asthma or severe pulmonary disease, unless otherwise recommended by your doctor;


• if you have a head injury that causes a severe headache or makes you feel sick. This is because the injection may make these symptoms worse or hide the extent of the head injury;


• if you have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen;


• if you have a heart problem after long-term lung disease (cor pulmonale);


• if you have severe kidney problems or moderate to severe liver problems. If you have other long term kidney or liver problems you should only use OxyNorm injection if recommended by your doctor;


• if you have ongoing problems with constipation;


• if you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks.

Children and adolescents under 18 years old should not use the injection.

Take special care with OxyNorm injection

Before treatment with OxyNorm injection tell your doctor or pharmacist:

• if you have an under-active thyroid gland (hypothyroidism), as you may need a lower dose of OxyNorm injection;


• if you have a severe headache or feel sick as this may indicate that the pressure in your skull is increased;


• if you have low blood pressure (hypotension);


• if you have a mental disorder as a result of an infection (toxic psychosis);


• if you have inflammation of the pancreas (pancreatitis) or problems with your gall bladder;


• if you have inflammatory bowel disease;


• if you have prostate problems;


• if you have poor adrenal gland function;


• if you are or have ever been addicted to alcohol or drugs;


• if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol or drugs.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. If you use OxyNorm injection with some other medicines, the effect of OxyNorm injection or the other medicines may be changed.

Tell your doctor or pharmacist:

• if you are taking medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);


• if you have recently been given an anaesthetic;


• if you are taking medicines to treat depression;


• if you are taking medicines to treat psychiatric or mental disorders;


• if you are taking other strong analgesics or ‘painkillers’;


• if you are taking muscle relaxants;


• if you are taking medicines to treat high blood pressure;


• if you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks.

Using OxyNorm injection with alcohol

Drinking alcohol during your treatment with OxyNorm injection may make you sleepy. If you are affected you should avoid drinking alcohol.

Pregnancy and breastfeeding

Do not use OxyNorm injection if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel sleepy when you first start using OxyNorm injection, or when increasing to a higher dose. If you are affected you should not drive or use machinery.

Important information about some of the ingredients of OxyNorm injection

This injection contains less than 1 mmol sodium (23 mg) per 1 ml, i.e. it is essentially “sodium-free”.

How to use OxyNorm injection

A doctor or nurse will usually prepare and administer the injection for you. The injection should be used immediately after opening. The dose and how often the injection is given may be adjusted according to the severity of your pain.

The usual starting dose for adults over 18 years old is dependent upon how the injection is administered. The usual starting doses are as follows:

• As a single injection into a vein, the usual dose is 1 to 10 mg given slowly over 1 to 2 minutes. This can be repeated every 4 hours.


• As an infusion into a vein, the usual starting dose is 2 mg/hour.


• As a single injection through a fine needle into the tissue under the skin, the usual starting dose is 5 mg repeated at 4-hourly intervals if needed.


• As an infusion through a fine needle into the tissue under the skin, the usual starting dose is 7.5 mg/day.


• If given by patient controlled analgesia (PCA), the dose is worked out according to your weight (0.03 mg per kg of body weight). Your doctor or nurse will set a suitable frequency.

The dose recommended by the doctor should not be exceeded. Check with the doctor or pharmacist
if you are unsure.

If you find that you are still in pain whilst being given OxyNorm injection discuss this with your
doctor.

If you use more OxyNorm injection than you should, or if someone else uses your injection

Call your doctor or hospital straight away. People who have been given an overdose may feel very sleepy and sick. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you
take this leaflet and any remaining injection with you to show to the doctor.

If you stop using OxyNorm injection

You should not suddenly stop using this injection unless your doctor tells you to. If you want to stop using your injection, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects.

If you have any further questions on the use of OxyNorm injection, ask your doctor or pharmacist.

Possible side effects

Like all medicines, OxyNorm injection can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

As with all strong painkillers, there is a risk that you may become addicted or reliant on OxyNorm
injection.

Common side effects

(Probably affecting more than 1 in 100 people using OxyNorm injection)

Most people will have constipation when they use OxyNorm injection. Your doctor can prescribe a laxative to overcome this problem.

You may feel sick or vomit (be sick) when using this injection, this should normally wear off after a few days however your doctor can prescribe an anti-vomiting medicine if it continues to be a problem.

You may find that you feel more sleepy than normal when you start using your injection or when your dose is increased. This should wear off after a few days.

The following side effects have also been commonly reported in patients treated with OxyNorm injection:

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea.


• Headache, confusion, a feeling of unusual weakness, dizziness, a feeling of ‘faintness’ especially on standing up, anxiety, nervousness, twitching, difficulty in sleeping, abnormal thoughts or dreams.


• Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex.


• Rash, itchy skin.


• Sweating, chills.

Uncommon side effects

(Probably affecting fewer than 1 in 100 people using OxyNorm injection)

• Difficulty in swallowing, belching, hiccups, wind, gastrointestinal disorders (e.g. upset stomach), changes in taste.


• A feeling of dizziness or ‘spinning’, hallucinations, mood changes, depression, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, shaking, difficulties with speech, reduced sensitivity to pain or touch, tingling in the hands or feet, seizures, fits or convulsions, blurred vision.


• Difficulty passing urine, impotence, decreased sexual drive, absence of menstrual periods.


• Fast, irregular heart beat, low blood pressure, flushing of the skin.


• Dehydration, thirst, swelling of the hands, ankles or feet.


• Dry skin, severe flaking or peeling of the skin.


• Redness of the face, reduction in size of the pupils in the eye, high temperature.


• Withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping using OxyNorm injection.

If you need to have blood tests remind your doctor that you are using OxyNorm injection. This is important because OxyNorm injection may change the way your liver works and this could affect the results of some blood tests.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store OxyNorm injection

Keep out of the reach and sight of children. Accidental overdose by a child is dangerous and may be fatal.

Do not use OxyNorm injection after the expiry date which is stated on the ampoule label and carton. EXP 08 2010 means that you should not use the injection after the last day of that month i.e. August 2010.

There are no special precautions for storage prior to use however once the ampoule is opened the injection should be used immediately. Any unused portion should be discarded immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What OxyNorm injection contains

The active ingredient is oxycodone hydrochloride.

The other ingredients are:

• Citric acid monohydrate


• Sodium citrate


• Sodium chloride


• Hydrochloric acid, dilute


• Sodium hydroxide


• Water for injections

What OxyNorm injection looks like and the contents of the pack

OxyNorm
injection is a clear, colourless solution supplied in clear glass ampoules. The 50 mg/ml strength is available as 1 ml of solution (containing 50 mg of oxycodone hydrochloride).

Marketing Authorisation Holder and Manufacturer

OxyNorm
injection is made by

Hamol Ltd

1 Thane Road

Nottingham

NG90 2DB

UK

The marketing authorisation holder is

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

UK

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on :

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: OxyNorm solution for injection or infusion

Reference number: 16950/0155

This leaflet was last approved in March 2009.

OxyNorm, NAPP and the NAPP device (logo) are Registered Trade Marks.

© 2009 Napp Pharmaceuticals Limited

P0183-A UK AW R2V0 12-03-09

Folivane-PRx DHA NF

Dosage Form: capsule
Folivane™-PRx DHA NF

Rx Prenatal Vitamin with Fish Oil-Based DHA

Rx Only.

Folivane-PRx DHA NF Description

Folivane™-PRx DHA NF capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Each softgel capsule is oblong, maroon and imprinted with "T544" in white ink.

* From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil.
Each softgel capsule contains:
Vitamin C (ascorbic acid, USP)	25 mg
Calcium (tribasic calcium phosphate, NF)	160 mg
Iron (ferrous fumarate, USP)	30 mg
Vitamin D3 (cholecalciferol, USP)	170 IU
Vitamin E (d-alpha tocopherol, USP)	30 IU
Vitamin B6 (pyridoxine hydrochloride, USP)	25 mg
Folic Acid, USP	1.24 mg
DHA (Docosahexaenoic Acid)*	265 mg
Docusate Sodium, USP	55 mg

Inactive Ingredients

Gelatin, Glycerin, Soybean Oil, Purified Water, Lecithin, Natural Creamy Orange Flavor, Yellow Beeswax, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1.

INDICATIONS

Folivane™-PRx DHA NF capsules are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Folivane™-PRx DHA NF may be useful in improving the nutritional status of women prior to conception.

Contraindications

Folivane™-PRx DHA NF capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

This product contains soybean oil and fish oil.

Warning

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Folivane-PRx DHA NF Dosage and Administration

Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.

How is Folivane-PRx DHA NF Supplied

Bottles of 30 softgel capsules NDC 13811-544-30.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F [see USP controlled room temperature].

Rx Only.

Manufactured for:

TRIGEN Laboratories, Inc., Sayreville, NJ 08872

www.trigenlab.com

Rev. 08/11

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 13811-544-30

Rx Only

Folivane™-PRx DHA

NF

Rx PRENATAL VITAMIN

30 CAPSULES

TRIGEN

LABORATORIES

FOLIVANE-PRX DHA  ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-544 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 25 mg Tribasic Calcium Phosphate (Calcium Cation) Tribasic Calcium Phosphate 160 mg Iron (Iron) Iron 30 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 170 [iU] Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 30 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg Folic Acid (Folic Acid) Folic Acid 1.24 mg Doconexent (Doconexent) Doconexent 265 mg Docusate Sodium (Docusate) Docusate Sodium 55 mg

Inactive Ingredients Ingredient Name Strength Gelatin   Glycerin   Soybean Oil   Water   Yellow Wax   FD&C Red No. 40   Titanium Dioxide   Ethyl Vanillin   FD&C Yellow No. 6   FD&C Blue No. 1

Product Characteristics Color RED (maroon) Score no score Shape CAPSULE (oblong) Size 25mm Flavor ORANGE (Creamy Orange) Imprint Code T544 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13811-544-30 30 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/2010

Labeler - TRIGEN Laboratories, Inc. (830479668)

Revised: 09/2011TRIGEN Laboratories, Inc.

insulin lispro and insulin lispro protamine

Generic Name: insulin lispro and insulin lispro protamine (IN soo lin LISS pro and IN soo lin LISS pro PRO ta meen)

Brand Names: HumaLOG Mix 50/50, HumaLOG Mix 50/50 KwikPen, HumaLOG Mix 50/50 Pen, HumaLOG Mix 75/25, HumaLOG Mix 75/25 KwikPen, HumaLOG Mix 75/25 Pen

What is insulin lispro and insulin lispro protamine?

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting form of insulin. Insulin lispro protamine is an intermediate-acting form of insulin.

Insulin lispro and insulin lispro protamine is used to treat type 1 diabetes in adults. It is usually given together with another long-acting insulin.

Insulin lispro and insulin lispro protamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about insulin lispro and insulin lispro protamine?

Use this medication within 15 minutes before eating a meal.

Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Signs of blood sugar that is too high (hyperglycemia) may include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your insulin dose.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

What should I discuss with my healthcare provider before using insulin lispro and insulin lispro protamine?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

To make sure you can safely use insulin lispro and insulin lispro protamine, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin lispro and insulin lispro protamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use insulin lispro and insulin lispro protamine?

Insulin is injected under the skin. You will be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use this medication within 15 minutes before eating a meal.

Insulin lispro and insulin lispro protamine should appear cloudy after mixing. Do not use the medication if it has changed colors or has any particles in it. Return the medication to your pharmacy for a new supply.

Use a different place on your injection skin area each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Ask your doctor how to adjust your insulin dose if needed. Do not change your medication dose or schedule without your doctor's advice. Wear a medical alert tag or carry an ID card stating that you have diabetes. Any medical care provider who treats you should know that you are diabetic. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Unopened vials may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days. Unopened injection pens may also be stored at room temperature for up to 10 days, away from heat and bright light. Throw away any insulin not used within 10 days. Storing after your first use: You may keep "in-use" vials in the refrigerator, protected from light. Use within 28 days. Do not refrigerate an in-use injection pen. Keep it at room temperature and use within 10 days.

Do not freeze insulin lispro and insulin lispro protamine, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since this medication is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin lispro and insulin lispro protamine, be sure to eat a meal within 15 minutes. Do not use extra insulin lispro and insulin lispro protamine to make up a missed dose.

Keep insulin lispro and insulin lispro protamine on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

What should I avoid while using insulin lispro and insulin lispro protamine?

Do not change the brand of insulin lispro and insulin lispro protamine or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. It can lower your blood sugar. Do not expose insulin lispro and insulin lispro protamine to high heat.

Insulin lispro and insulin lispro protamine side effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Insulin lispro and insulin lispro protamine can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin lispro and insulin lispro protamine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Insulin lispro and insulin lispro protamine Dosing Information

Usual Adult Dose for Diabetes Mellitus Type I:

Insulin lispro-lispro protamine is a mixture of rapid and intermediate-acting insulins and is given subcutaneously 1 to 3 times daily. It should be given within 15 minutes before a meal.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal.

Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2-5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.

Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type II:

Insulin lispro-lispro protamine is a mixture of rapid and intermediate-acting insulins and is given subcutaneously 1 to 3 times daily. It should be given within 15 minutes before a meal.

Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents. Insulin may be considered if patients are very hyperglycemic or symptomatic and/or not controlled with oral agents. Insulin may exacerbate obesity, further increase insulin resistance, and increase the frequency of hypoglycemia.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen:
Initial dose, monotherapy: Total insulin requirement: 0.1 unit/kg/day. When insulin is used alone, twice daily injections are recommended for better glycemic control. The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.
Maintenance dose, monotherapy: An average of 0.65 units/kg/day in 2 divided doses of lispro-lispro protamine insulin has been used in studies. Total daily insulin requirements may progress to 1.5 to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Intensive regimen:
The necessity for and efficacy of intensive insulin therapy in type II diabetes has been controversial. The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Initial dose, monotherapy: 0.5 to 1.5 unit/kg/day subcutaneously.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 2.5 units/kg or higher in patients with obesity and insulin resistance.

What other drugs will affect insulin lispro and insulin lispro protamine?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

• 
  

  albuterol (Proventil, Ventolin);

  
  


• 
  

  clonidine (Catapres);

  
  


• 
  

  reserpine; or

  
  


• 
  

  beta-blockers such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

  
  

There are many other medicines that can increase or decrease the effects of insulin lispro and insulin lispro protamine on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More insulin lispro and insulin lispro protamine resources

• Insulin lispro and insulin lispro protamine Use in Pregnancy & Breastfeeding
• Insulin lispro and insulin lispro protamine Drug Interactions
• Insulin lispro and insulin lispro protamine Support Group
• 1 Review for Insulin lispro and insulin lispro protamine - Add your own review/rating

Compare insulin lispro and insulin lispro protamine with other medications

• Diabetes, Type 1
• Diabetes, Type 2

Where can I get more information?

• Your pharmacist can provide more information about insulin lispro and insulin lispro protamine.

MembraneBlue

Generic Name: trypan blue (Intraocular route)

TRYE-pan BLOO

Commonly used brand name(s)

In the U.S.

• MembraneBlue


• VisionBlue

Available Dosage Forms:

• Solution

Therapeutic Class: Surgical Aid, Ocular

Uses For MembraneBlue

Trypan blue is used as a surgical aid during cataract eye surgery. It is a blue dye that works by staining a part of the eye called the retinal membrane. This creates a contrast between the different parts of your eye and helps your doctor to see the retinal membrane more clearly.

This medicine is available only with your doctor's prescription.

Before Using MembraneBlue

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of trypan blue in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trypan blue in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of trypan blue

This section provides information on the proper use of a number of products that contain trypan blue. It may not be specific to MembraneBlue. Please read with care.

A doctor will give you this medicine during your eye surgery. Any extra amount of this medicine will be washed out of your eye at the end of the surgery.

Precautions While Using MembraneBlue

Your doctor will want to check your progress at regular visits during the first few weeks after you receive this medicine.

Some of this medicine may remain in your eye for a few days. It might make your eye or tears appear to be blue. Talk to your doctor if you have any questions.

MembraneBlue Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Blue color remaining in the eye


• Discoloration of artificially implanted lens

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: MembraneBlue side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More MembraneBlue resources

• MembraneBlue Side Effects (in more detail)
• MembraneBlue Use in Pregnancy & Breastfeeding
• MembraneBlue Support Group
• 0 Reviews for MembraneBlue - Add your own review/rating

• MembraneBlue Prescribing Information (FDA)


• Visionblue Prescribing Information (FDA)

Compare MembraneBlue with other medications

• Ophthalmic Surgical Staining

influenza virus vaccine injection

Generic Name: influenza virus vaccine (injection) (in floo ENZ a VYE rus VAK seen)

Brand names: Afluria 2011-2012, Afluria Preservative-Free 2011-2012, Fluarix 2010-2011, Fluarix 2011-2012, FluLaval 2011-2012, Fluvirin 2011-2012, Fluvirin Preservative-Free 2011-2012, Fluzone 2011-2012, Fluzone High-Dose 2011-2012, Fluzone Intradermal 2011-2012, Fluzone Preservative-Free 2011-2012, Fluzone Preservative-Free Pediatric 2011-2012, ...show all 38 brand names.Flushield, Fluvirin, Fluzone, Fluogen, FluShield (obsolete), Fluzone SV, Fluzone WV, Fluzone PFS, Fluzone Preservative-Free Pediatric, Fluzone Preservative-Free, Fluarix, Fluvirin Preservative-Free, FluLaval, Afluria, Afluria Preservative-Free, Fluzone High-Dose, Agriflu, FluLaval 2010-2011, Afluria 2010-2011, Fluzone 2010-2011, Fluvirin 2010-2011, Afluria Preservative-Free 2010-2011, Fluzone Preservative-Free 2010-2011, Fluzone Preservative-Free Pediatric 2010-2011, Fluvirin Preservative-Free 2010-2011, Fluzone High-Dose 2010-2011

What is influenza virus vaccine?

Influenza virus (commonly known as "the flu") is a serious disease caused by a virus. Influenza virus can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The virus can also be passed through contact with objects the infected person has touched, such as a door handle or other surfaces.

Influenza virus vaccine is used to prevent infection caused by influenza virus. The vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year.

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine.

Influenza virus vaccine works by exposing you to a small dose of the virus, which helps your body to develop immunity to the disease. Influenza virus vaccine will not treat an active infection that has already developed in the body.

Influenza virus vaccine is for use in adults and children who are at least 6 months old.

Becoming infected with influenza is much more dangerous to your health than receiving this vaccine. Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

What is the most important information I should know about this vaccine?

The injectable influenza virus vaccine (flu shot) is a "killed virus" vaccine. Influenza virus vaccine is also available in a nasal spray form, which is a "live virus" vaccine. This medication guide addresses only the injectable form of this vaccine.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side effects.

Like any vaccine, influenza virus vaccine may not provide protection from disease in every person. This vaccine will not prevent illness caused by avian flu ("bird flu").

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

Becoming infected with influenza is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

You should not receive this vaccine if you have ever had an allergic reaction to a flu vaccine, or if you have:

• 
  

  an active or uncontrolled neurologic disorder (such as Parkinson's disease, Alzheimer's disease, or epilepsy);

  
  


• 
  

  a history of seizures;

  
  


• 
  

  a history of Guillian-Barre syndrome (within 6 weeks after receiving a vaccine);

  
  


• 
  

  if you are allergic to eggs.

  
  

To make sure you can safely receive this vaccine, tell your doctor if you have any of these other conditions:

• 
  

  a bleeding or blood clotting disorder such as hemophilia or easy bruising;

  
  


• 
  

  a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);

  
  


• 
  

  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

  
  


• 
  

  if you are allergic to latex rubber.

  
  

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with influenza. It is not known whether influenza virus vaccine passes into breast milk or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby. This vaccine should not be given to a child younger than 6 months old.

How is this vaccine given?

Some brands of this vaccine are made for use in adults and not in children. Your child's doctor can recommend the best influenza virus vaccine for your child.

This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

You should receive a flu vaccine every year. Your immunity will gradually decrease over the 12 months after you receive the influenza virus vaccine. Children receiving this vaccine may need a booster shot one month after receiving the first vaccine.

The influenza virus vaccine is usually given in October or November. Some people may need to have their vaccines earlier or later. Follow your doctor's instructions.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

What happens if I miss a dose?

Since flu shots are usually given only one time per year, you will most likely not be on a dosing schedule. Call your doctor if you forget to receive your yearly flu shot in October or November.

If your child misses a booster dose of this vaccine, call your doctor for instructions.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Influenza virus injectable vaccine side effects

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side effects. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);

  
  


• 
  

  high fever;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  unusual bleeding.

  
  

Less serious side effects may include:

• 
  

  low fever, chills;

  
  


• 
  

  mild fussiness or crying;

  
  


• 
  

  redness, bruising, pain, swelling, or a lump where the vaccine was injected;

  
  


• 
  

  headache, tired feeling; or

  
  


• 
  

  joint or muscle pain.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Influenza virus vaccine Dosing Information

Usual Adult Dose for Influenza Prophylaxis:

0.5 mL once by intramuscular injection

or

Fluzone Intradermal - 18 through 64 years: 0.1 mL once by intradermal injection

Usual Geriatric Dose for Influenza Prophylaxis:

65 years or older:
influenza virus vaccine, inactivated high-dose preservative-free intramuscular suspension (Fluzone High Dose):
0.5 mL once by intramuscular injection

Usual Pediatric Dose for Influenza Prophylaxis:

Afluria:
Children 5 years through 8 years of age not previously vaccinated with an influenza vaccine, or vaccinated for the first time last season with only one dose: Administer two 0.5 mL doses by intramuscular injection, one on Day 1 and another approximately 4 weeks later.
Children 5 years through 8 years of age given two doses last season, or at least one dose two or more years ago: Administer a single 0.5 mL dose by intramuscular injection.
Children 9 years of age and older: Administer a single 0.5 mL dose by intramuscular injection.

Note: Although approved for use in children 5 years to 8 years of age, the ACIP does not recommend use of Afluria in infants or children less than 8 years of age due to an increased incidence of fever and febrile seizures noted during the 2010 to 2011 influenza season. However, if other age appropriate vaccines are not available, children 5 to 8 years of age who are also considered at risk for influenza complications may be given Afluria after benefits and risks are discussed with parents or caregivers.

Fluzone:
6 months to 35 months: 0.25 mL by intramuscular injection (1 or 2 doses).
3 years to 8 years: 0.5 mL by intramuscular injection (1 or 2 doses).
Previously unvaccinated children 6 months to less than 9 years of age should receive 2 doses, given more than 1 month apart in order to achieve a satisfactory antibody response. Second dose should preferably be administered before the onset of influenza season.
9 years or older: 0.5 mL once by intramuscular injection.

Fluvirin:
4 to 8 years of age: 0.5 mL dose via intramuscular injection, one or two doses.
Children aged 4 to 8 years should receive 2 doses of vaccine separated by at least 4 weeks, if they have not been vaccinated previously at any time with any influenza virus vaccine. Children aged 4 to 8 years who received only 1 dose in their first year of vaccination in the previous season should receive 2 doses of vaccine separated by at least 4 weeks. Children aged 4 to 8 years who have been vaccinated with two doses of any influenza virus vaccine in the previous season, or with one dose in the year prior to the previous season, should receive only one dose.
9 years and older: A single 0.5 mL intramuscular injection.

Fluarix:
3 years to 8 years of age previously unvaccinated or vaccinated for the first time last season with only one dose receive two 0.5 mL doses; each 0.5 mL dose is administered at least 4 weeks apart. Children 3 years to 8 years of age previously vaccinated with 2 doses of any influenza vaccine receive only one 0.5 mL dose.
Children 9 years of age and older receive only one 0.5 mL dose.

What other drugs will affect influenza virus injectable vaccine?

Before receiving this vaccine, tell your doctor if you are using phenytoin (Dilantin), theophylline (Respbid, Slo-Bid, Theodur, Uniphyl), or a blood thinner (warfarin, Coumadin, Jantoven).

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and other drugs may interact with influenza virus vaccine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More influenza virus vaccine resources

• Influenza virus vaccine Use in Pregnancy & Breastfeeding
• Influenza virus vaccine Drug Interactions
• Influenza virus vaccine Support Group
• 1 Review for Influenza virus vaccine - Add your own review/rating

Compare influenza virus vaccine with other medications

• Influenza Prophylaxis

Where can I get more information?

• Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Zutectra

1. Name Of The Medicinal Product

Zutectra

2. Qualitative And Quantitative Composition

One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU.

Human protein 150 mg/ml of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml.

Distribution of IgG subclasses:

IgG1: 59 %

IgG2: 35 %

IgG3: 3 %

IgG4: 3 %

IgA content max. 6 mg/ml.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection in pre-filled syringe.

The solution is clear and pale yellow or light brown.

4. Clinical Particulars

4.1 Therapeutic Indications

Prevention of hepatitis B virus (HBV) re-infection in HBV-DNA negative patients

Zutectra is indicated in adults only.

The concomitant use of adequate virostatic agents should be considered, if appropriate, as standard of hepatitis B re-infection prophylaxis.

4.2 Posology And Method Of Administration

Posology

In HBV-DNA negative adults

- patients with bodyweight < 75 kg: 500 IU (1 ml)/week

- patients with bodyweight

Prior to the initiation of subcutaneous treatment with Zutectra, anti-HBs serum levels should be stabilised with an adequate intravenous hepatitis B immunoglobulin to levels at or above 300

Patients must be monitored for serum anti-HBs antibody levels regularly.

There is no relevant indication for use of Zutectra in children.

Method of administration

Zutectra should be administered via the subcutaneous route.

Zutectra is accompanied by a package leaflet with detailed instruction for use to be followed. Injection of the medicinal product by the patient or by caregiver in a home treatment requires training by a physician experienced in the guidance of patients for home treatment. The patient or caregiver will be instructed in injection techniques, the keeping of a treatment diary and measures to be taken in case of severe adverse events. A sufficient surveillance period with stable anti-HBs trough serum levels of> 100 IU/l as well as a fixed dosage regimen is required. In addition patient or caregiver must comply with the injection technique as well as with the dosing regimen to ensure anti-HBs trough serum levels> 100 IU/l after extended periods between level controls.

4.3 Contraindications

Hypersensitivity to any of the components.

Hypersensitivity to human immunoglobulins.

Zutectra must not be administered intravascularly.

4.4 Special Warnings And Precautions For Use

Ensure that Zutectra is not administered into a blood vessel, because of the risk of shock.

If the recipient is a carrier of HBsAg, there is no benefit in administering this medicinal product.

There is no data about efficacy in post-exposure prophylaxis.

True hypersensitivity reactions are rare.

Zutectra contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with Zutectra against the potential risk of hypersensitivity reactions.

Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.

Potential complications can often be avoided by ensuring that:

- patients are not sensitive to human normal immunoglobulin, by first injecting the medicinal product slowly;

- patients are carefully monitored for any symptoms throughout the injection. The patients should be observed for at least 20 minutes after administration.

Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.

There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.

It is strongly recommended that every time that Zutectra is administered to a patient, the name and batch number of the medicinal product are recorded in order to maintain a link between the patient and the batch of the medicinal product. This recommendation applies also for documentation in the treatment diary during self-administration of the medicinal product in a home treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Live attenuated virus vaccines

Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of 3 months. After administration of this medicinal product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.

Human hepatitis B immunoglobulin should be administrated three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of human hepatitis B immunoglobulin.

Interference with serological testing

After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coombs' test).

4.6 Pregnancy And Lactation

The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

The following undesirable effects have been reported in the context of 697 subcutaneous applications of Zutectra during two completed clinical trials.

Most adverse drug reactions (ADRs) observed in the two clinical trials were mild to moderate in nature.

The ADRs reported in the two trials are summarised and categorised according to the MedDRA system organ class and frequency below. Frequency per injection has been evaluated using the following criteria: very common (

The effects were grouped by system organ classes under relevant medical headings.

Unspecific hypersensitivity reactions:

MedDRA System Organ Class	Undesirable effects	Frequency
Nervous system disorders	Headache	Uncommon
Gastrointestinal disorders	Upper abdominal pain	Uncommon

Injection site reactions:

MedDRA System Organ Class	Undesirable effects	Frequency
General disorders and administration site conditions	Pain, urticaria, haematoma	Common

Other:

Additionally the following single case reports have been received from completed clinical trials:

General disorders and administration site conditions: fatigue, tiredness.

With normal immunoglobulins adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.

Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.

Local reactions at injection sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash.

For safety with respect to transmissible agents, see section 4.4.

4.9 Overdose

Consequences of an overdose are not known.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Specific immunoglobulins, ATC code: J06BB04

Zutectra contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).

Clinical experience

The open, prospective, single-arm clinical trial (Biotest 958) enrolled 23 liver transplant recipients, who had been receiving intravenous hepatitis B immunoglobulin prophylaxis and subsequently switched to subcutaneous Zutectra. The weekly subcutaneous dose was 500 IU for patients with bodyweight < 75 kg (a dose increase to 1000 IU was allowed, if medically required to maintain a safety level of> 100 IU) and 1000 IU for patients with bodyweight

The mean anti-HBs serum level before switching was 393±139 IU/l. All patients used antiviral medication.

Using the Clopper Pearson method, the failure rate after 18 weeks was 0 % for patients of the ITT set (95 % CI: [0, 14.8 %]). A failure rate of 0 % was also found for the facultative extension phase (week 24) (95 % CI: [0, 20.6 %])

5.2 Pharmacokinetic Properties

Zutectra is slowly absorbed into the recipient's circulation and reaches a maximum after a delay of 2

Zutectra has a half-life of about 3

IgG and IgG-complexes are broken down in the reticuloendothelial system.

5.3 Preclinical Safety Data

Immunoglobulins are normal constituents of the human body, therefore toxicity testing in heterologous species is of no relevance.

In a local tolerance trial in rabbits, there was no evidence of irritation attributable to Zutectra.

No other non-clinical trials have been carried out.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycine

Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products.

No other preparations may be added to the Zutectra solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins.

6.3 Shelf Life

18 months.

The solution should be administered immediately after opening the syringe.

6.4 Special Precautions For Storage

Store and transport refrigerated (2°C

Do not freeze.

Keep the container in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

One ml solution in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber).

Pack size of five syringes in a blistered pack.

6.6 Special Precautions For Disposal And Other Handling

This medicinal product should be brought to room temperature (approx. 23°C

The solution can vary from colourless to pale-yellow up to light brown.

Solutions that are cloudy or have deposits should not be used.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Biotest Pharma GmbH

Landsteinerstrasse 5

D-63303 Dreieich

Germany

Tel.: +49 6103 801

Telefax: +49 6103 801

8. Marketing Authorisation Number(S)

EU/1/09/600/001

9. Date Of First Authorisation/Renewal Of The Authorisation

30/11/2009

10. Date Of Revision Of The Text

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.

methyldopa Oral, Intravenous

meth-il-DOE-pa

Commonly used brand name(s)

In the U.S.

• Aldomet

Available Dosage Forms:

• Tablet


• Suspension


• Solution

Therapeutic Class: Antihypertensive

Pharmacologic Class: Alpha-Adrenergic Agonist

Uses For methyldopa

Methyldopa belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension).

High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Methyldopa works by controlling impulses along certain nerve pathways. As a result, it relaxes blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

Methyldopa is available only with your doctor's prescription.

Before Using methyldopa

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For methyldopa, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methyldopa or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of methyldopa in children with use in other age groups, methyldopa is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Dizziness or lightheadedness and drowsiness may be more likely to occur in the elderly, who are more sensitive to the effects of methyldopa.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking methyldopa, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using methyldopa with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

Using methyldopa with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Entacapone


• Pseudoephedrine

Using methyldopa with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprenolol


• Bisoprolol


• Ferric Ammonium Citrate


• Haloperidol


• Iron


• Phenylpropanolamine


• Sotalol


• Timolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of methyldopa. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or


• Parkinson's disease—Methyldopa may make these conditions worse

• Kidney disease or


• Liver disease—Effects of methyldopa may be increased because of slower removal from the body

• Mental depression (history of)—Methyldopa can cause mental depression

• Pheochromocytoma—Methyldopa may interfere with tests for the condition; in addition, there have been reports of increased blood pressure

• If you have taken methyldopa in the past and developed liver problems

Proper Use of methyldopa

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that methyldopa will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

Dosing

The dose of methyldopa will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of methyldopa. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension or tablets):
  
  • For high blood pressure:
    
    • Adults—250 milligrams (mg) to 2 grams a day. This is divided into two to four doses.
    
    
    • Children—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 10 mg per kilogram (kg) (4.5 mg per pound) of body weight a day. This is divided into two to four doses. Your doctor may increase the dose as needed.
    
    
  
  


• For injection dosage form:
  
  • For high blood pressure:
    
    • Adults—250 to 500 mg mixed in 100 milliliters (mL) of solution (5% dextrose) and slowly injected into a vein every six hours as needed.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight. This is mixed in a solution (5% dextrose) and slowly injected into a vein every six hours as needed.
    
    
  
  

Missed Dose

If you miss a dose of methyldopa, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using methyldopa

It is important that your doctor check your progress at regular visits to make sure that methyldopa is working properly.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

If you have a fever and there seems to be no reason for it, check with your doctor. This is especially important during the first few weeks you take methyldopa, since fever may be a sign of a serious reaction to methyldopa.

Before having any kind of surgery (including dental surgery) or emergency treatment, make sure the medical doctor or dentist in charge knows that you are taking methyldopa.

Methyldopa may cause some people to become drowsy or less alert than they are normally. This is more likely to happen when you begin to take it or when you increase the amount of medicine you are taking. Make sure you know how you react to methyldopa before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.

Methyldopa may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Tell the doctor in charge that you are taking methyldopa before you have any medical tests. The results of some tests may be affected by methyldopa.

methyldopa Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Fever, shortly after starting to take methyldopa

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Swelling of feet or lower legs

Less common

• Mental depression or anxiety


• nightmares or unusually vivid dreams

Rare

• Dark or amber urine


• diarrhea or stomach cramps (severe or continuing)


• fever, chills, troubled breathing, and fast heartbeat


• general feeling of discomfort or illness or weakness


• joint pain


• pale stools


• skin rash or itching


• stomach pain (severe) with nausea and vomiting


• tiredness or weakness after having taken methyldopa for several weeks (continuing)


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Drowsiness


• dryness of mouth


• headache

Less common

• Decreased sexual ability or interest in sex


• diarrhea


• dizziness or lightheadedness when getting up from a lying or sitting position


• nausea or vomiting


• numbness, tingling, pain, or weakness in hands or feet


• slow heartbeat


• stuffy nose


• swelling of breasts or unusual milk production

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: methyldopa Oral, Intravenous side effects (in more detail)

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