País: Israel
Idioma: inglés
Fuente: Ministry of Health
HUMAN HEPATITIS B IMMUNOGLOBULIN
KAMADA LTD, ISRAEL
J06BA02
SOLUTION FOR INFUSION
HUMAN HEPATITIS B IMMUNOGLOBULIN 50 MG / 1 ML
I.V
Required
BIOTEST PHARMA GMBH, GERMANY
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Prophylaxis against hepatitis B in adults and children over 2 years of age who have not been vaccinated against hepatitis B (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis B by accidental contact with Hepatitis B virus containing material following: - percutaneous exposure (e.g. accidental needle stick). - direct mucous membrane contact. When the administration of an intramuscular hepatitis B immunoglobulin is not possible. The immunoglobulin should be administered in association with hepatitis B vaccine. Prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis B virus. Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B virus carrier mother.
2022-11-30
HEAD OFFICE 2 Holzman St., Science Park, P.O. Box 4081, Rehovot, 7670402, Israel | Tel. +972-8-9406472 | Fax. +972-89406473 PLANT Kibbutz Beit Kama, M.P Negev 8532500, Israel | Tel. +972-8-9913111 | Fax. +972-8-9912083 ץרמ 9 201 ,ה/דבכנ ת/חקור ,ה/אפור ןוכדיע לע עידוהל תשקבמ עדהמק תרבח ןולע אפורל :רישכתה רובע HEPATECT ® CP ; CP טקטפה SOLUTION FOR INFUSION ןוישירל םאתהב םיליעפ םיביכרמ : Protein Immunoglobulin 50mg/ml :היוותה A. Prophylaxis against hepatitis B in adults and children over two years of age who have not been vaccinated against hepatitis B (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis B by accidental contact with hepatitis B virus containing material following – percutaneous exposure (e.g., accidental needle stick) – direct mucous membrane contact When the administration of an intramuscular hepatitis B immunoglobulin is not possible. The immunoglobulin should be administered in association with hepatitis B vaccine. B. Prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis B virus C. Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B virus carrier-mother. יונישה תוהמ םי : .אפורל ןולע ןוכדיע הרמחה םיווהמה םייונישה םיניוצמ וז העדוהב בוהצב ושגדוה( ; הצוח וק י"ע ןמוס קחמנש טסקט ) םייוניש ןולעב . .הרמחה םניאש םיפסונ 4.8 UNDESIRABLE EFFECTS There are no robust data on the frequency of undesirable effects from clinical trials. Summary of the safety profile Most adverse drug reactions (ADRs) were mild to moderate in nature. In isolated cases human normal immunoglobulins may cause an anaphylactic shock. Tabulated list of adverse reactions: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequ Leer el documento completo
Page 1 of 11 HEPATECT ® CP 1. NAME OF THE MEDICINAL PRODUCT Hepatect CP 50 IU/ml solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human hepatitis B immunoglobulin. Human protein 50 g/l of which at least 96% is IgG, with a content of antibodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml Each vial of 2 ml contains: 100 IU Each vial of 10 ml contains: 500 IU Each vial of 40 ml contains: 2000 IU Each vial of 100 ml contains: 5000 IU Distribution of IgG subclasses (approx. values): IgG1: 59% IgG2: 35 % IgG3: 3 % IgG4: 3 % The maximum IgA content is 2000 micrograms/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion The solution is clear or slightly opalescent and colourless to pale yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A. Prophylaxis against hepatitis B in adults and children over two years of age who have not been vaccinated against hepatitis B (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis B by accidental contact with hepatitis B virus containing material following – percutaneous exposure (e.g., accidental needle stick) – direct mucous membrane contact When the administration of an intramuscular hepatitis B immunoglobulin is not possible. Page 2 of 11 The immunoglobulin should be administered in association with hepatitis B vaccine. B. Prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis B virus C. Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B virus carrier-mother. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _PREVENTION OF HEPATITIS B RE-INFECTION AFTER LIVER TRANSPLANTATION FOR HEPATITIS B INDUCED _ _LIVER FAILURE: _ _ _ In adults: 10 000 IU on the day of transplantation, peri-operatively then 2000-10 000 IU (40-200 ml)/day for 7 days, and as necessary to maintain antibody levels above 100-150 IU/l in HBV- DNA negative patients and above 500 IU/l in HBV-DNA positive p Leer el documento completo