HEPATECT CP 50 IU/ml solution for infusion
Human hepatitis B immunoglobulin for intravenous administration
Information for medical or health care professionals is provided at the end of this leaflet in a separate section.
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may want 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What HEPATECT CP is and what it is used for
2. Before you use HEPATECT CP
3. How to use HEPATECT CP
4. Possible side-effects
5. How to store HEPATECT CP
6. Further information
What Hepatect Cp Is And What It Is Used For
HEPATECT CP contains the active ingredient human hepatitis B immunoglobulin, which can protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus.
HEPATECT CP is a solution for infusion (into a vein) and comes in vials containing 2 ml (100 International Units [IU]), 10 ml (500 IU) and 40 ml (2000 IU).
HEPATECT CP is used to give immediate and long-term immunity (protection) to:
- prevent hepatitis B infection in patients who have not been vaccinated or fully vaccinated against hepatitis B and who are at risk of infection with hepatitis B.
- prevent infection of a transplanted liver in patients who test positive for hepatitis B.
- newborn babies whose mothers are infected with the hepatitis B virus.
- protect patients for whom hepatitis B vaccination has not provided adequate protection.
Before You Use Hepatect Cp
You should not be given HEPATECT CP if you,
- are allergic (hypersensitive) to human immunoglobulin or any of the other ingredients of HEPATECT CP (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
- have already been fully vaccinated against hepatitis B and you are immune.
Take special care with HEPATECT CP (and talk to your doctor) if you
- suffer from a condition with low antibody levels in your blood (hypo- or agammaglobulinemia)
- have had a reaction to other antibodies (in rare cases you may be at risk of allergic reactions)
Your doctor will take special care if you are overweight, elderly, diabetic, or if you suffer from high blood pressure, low blood volume (hypovolaemia), have an IgA deficiency, have problems with your blood vessels (vascular diseases) or are at risk for thrombotic events.
Inform your doctor if you have been vaccinated against hepatitis B within the past four weeks. You may need to be re-vaccinated if you are given HEPATECT CP.
Please note - reactions
You will be carefully observed during the infusion period with HEPATECT CP to make sure that you do not suffer a reaction. Your doctor will make sure that the rate at which HEPATECT CP is infused is suitable for you.
If you have a reaction during the infusion of HEPATECT CP, tell your doctor immediately. The rate of infusion can be slowed or the infusion can be stopped altogether.
Information on transmission of infectious agents
HEPATECT CP is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, it is important to prevent infections being passed on to patients. Blood donors are tested for viruses and infections. Manufacturers of these products also process the blood or plasma to inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are given, the possibility of passing on infection cannot be totally excluded.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
HEPATECT CP can reduce the effectiveness of some vaccines such as:
- measles
- rubella
- mumps
- chicken pox
You may have to wait up to 3 months before you can have some vaccines.
Effects on blood tests
HEPATECT CP can affect blood tests. If you have a blood test after receiving HEPATECT CP, please inform the person taking your blood or your doctor that you have received HEPATECT CP.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Your doctor will decide if HEPATECT CP may be used during pregnancy and breast-feeding.
Driving and using machines
HEPATECT CP has no known effects on your ability to drive or use machines.
How To Use Hepatect Cp
HEPATECT CP is intended for intravenous administration (infusion into a vein). It is given to you by a doctor or nurse. The dose will depend on your condition and your body weight. Your doctor will know the right amount to give you.
At the beginning of your infusion you will receive HEPATECT CP at a slow rate. Your doctor may then gradually increase the infusion rate.
If you have any further questions on the use of this product, ask your doctor or nurse.
Hepatect CP Side Effects
Like all medicines, HEPATECT CP can have side effects, although not everybody gets them.
Rarely, the following may occur:
- chills
- headache
- fever
- vomiting
- malaise (feeling sick)
- nausea (urge to vomit)
- low blood pressure
- allergic reactions
- skin (cutaneous) reactions such as erythema (redness), itching
- tachycardia (faster heart beat)
Very rarely, the following may occur:
- severe allergic reactions (anaphylactic shock)
- joint pain
With human immunoglobulin the following has been observed:
- temporary meningitis (inflammation of the brain lining)
- decrease of red blood cells (reversible haemolytic anaemia/haemolysis)
- an increase in the serum creatinine (a waste product) and/or sudden kidney failure
- cases of blood clots in the veins (thromboembolic reactions) have been reported in the elderly, in patients with signs of cerebral or cardiac ischemia, and in overweight and patients with very low blood volume (severely hypovolaemic).
If a side effect occurs, the infusion rate will be decreased or stopped.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Hepatect Cp
Keep out of the reach and sight of children.
Your pharmacist or doctor knows how to store HEPATECT CP.
It should be kept in the outer carton to protect it from light.
HEPATECT CP should be stored in a refrigerator at 2-8 °C. Do not freeze.
Further Information
What HEPATECT CP contains:
- The active substance of HEPATECT CP is human hepatitis B immunoglobulin for intravenous administration.
HEPATECT CP contains 50 mg/ml of human plasma protein of which at least 96 % is immunoglobulin G (IgG). The content of hepatitis B antibody is 50 IU/ml. The maximum immunoglobulin A (IgA) content is 2 mg/ml. The IgG subclass distribution is approx.
59 % IgG1, 35 % IgG2, 3 % IgG3 and 3 % IgG4. - The other ingredients are glycine and water for injections.
What HEPATECT CP looks like and the contents of the pack
HEPATECT CP is a solution for infusion. The solution is clear to faintly opalescent (milky colours like an opal) and colourless to pale yellow.
Pack containing 1 vial with 100 IU in 2 ml solution
Pack containing 1 vial with 500 IU in 10 ml solution
Pack containing 1 vial with 2000 IU in 40 ml solution
Marketing Authorisation Holder and Manufacturer:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
West Midlands
PL 04500/0006
This leaflet was last approved in October 2008.
No comments:
Post a Comment