Country: European Union
Language: English
Source: EMA (European Medicines Agency)
human hepatitis B immunoglobulin
Cangene Europe Limited
J06BB04
human hepatitis B immunoglobulin
Specific immunoglobulins
Immunization, Passive; Hepatitis B
Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown).- In haemodialysed patients, until vaccination has become effective.- In the newborn of a hepatitis B virus carrier-mother.- In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for intramuscular use.
Withdrawn
2010-03-16
Medicinal product no longer authorised 16 B. PACKAGE LEAFLET Medicinal product no longer authorised 17 PACKAGE LEAFLET: INFORMATION FOR THE USER IMMUNOGAM 312 IU/ML SOLUTION FOR INJECTION Human Hepatitis B Immunoglobulin 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. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What ImmunoGam is and what it is used for 2. Before you receive ImmunoGam 3. How ImmunoGam is administered 4. Possible side effects 5. How to store ImmunoGam 6. Further information 1. WHAT IMMUNOGAM IS AND WHAT IT IS USED FOR WHAT IMMUNOGAM IS ImmunoGam belongs to a group of medicines containing immunoglobulins (antibodies which can protect against certain infections), which are present in your blood. ImmunoGam contains increased levels of human hepatitis B immunoglobulins mainly immunoglobulin G (IgG) and is obtained from blood plasma of screened donors from the USA. WHAT IMMUNOGAM IS USED FOR ImmunoGam provides protection against hepatitis B virus for a short period of time and it is used to treat the following: - Accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown). - Haemodialysed patients, until vaccination has become effective. - Newborn of a hepatitis B virus carrier-mother. - Subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. 2. BEFORE YOU RECEIVE IMMUNOGAM YOU SHOULD NOT BE GIVEN IMMUNOGAM - if you have previously developed an allergic reaction to human immunoglobulins, to other blood products or to any of the other ingredients of ImmunoGam. - if you have an IgA deficiency such that you have developed an allergic reaction to IgA containing pr Read the complete document
Medicinal product no longer authorised 1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT ImmunoGam 312 IU/ml solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 312 IU Human hepatitis B immunoglobulin, corresponding to a protein content of 30-70 mg/ml of which 96% is Immunoglobulin G (IgG). One vial contains 312 IU of anti-HBs in 1 ml One vial contains 1560 IU of anti-HBs in 5 ml The immunoglobulin IgG subclasses are: IgG1: 64-67% IgG2: 25-27% IgG3: 7-9% IgG4: 0.1-0.3% IgA content is less than 40 micrograms/ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. ImmunoGam is a clear to slightly opalescent and colourless or pale yellow liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown). - In haemodialysed patients, until vaccination has become effective. - In the newborn of a hepatitis B virus carrier-mother. - In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for imtramuscular use. Medicinal product no longer authorised 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology - Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: At least 500 IU, depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 - 72 hours. - Immunoprophylaxis of hepatitis B in haemodialysed patients: 8-12 IU/kg with a maximum of 500 IU, every 2 months until seroconversion following vaccination. - Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier Read the complete document