Human hepatitis B immunoglobulin Other names: Human antihepatitis B immunoglobulin

Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as rubella, mumps, measles and varicella. After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In case of measles vaccination, this impairment may persist for up to 1 year. Therefore, patients receiving measles vaccine should have their antibody status checked.

Avoidance of concomitant use of loop diuretics.

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. Intravenous immunoglobulin G products have been shown to cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are expected.

Immunoglobulins are excreted into human milk. No negative effects on the breastfed newborns/infants are anticipated.

Fertility

Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.

Hepatitis B immunoglobulin solution for infusion has minor influence on the ability to drive and use machines. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.

Summary of the safety profile

Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass :

• chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain
• reversible haemolytic reactions; especially in those patients with blood groups A, B, and AB and (rarely) haemolytic anaemia requiring transfusion
• (rarely) a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration
• (rarely) transient cutaneous reactions (including cutaneous lupus erythematosus – frequency unknown)
• (very rarely) thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses
• cases of reversible aseptic meningitis
• cases of increased serum creatinine level and/or occurrence of acute renal failure
• cases of Transfusion Related Acute Lung Injury (TRALI)

List of adverse reactions

The list presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Adverse reactions from clinical trials: In four clinical trials no adverse reactions with Hepatect CP were identified.

Adverse reactions from post-marketing experience and non-interventional studies (frequencies not known – cannot be estimated from the available data):

Paediatric population

Adverse reactions in children are expected to be the same as in adults.