Zutectra · 4.3 Contraindications · 1

HOS-095428 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Most adverse reactions were mild to moderate in nature. In isolated cases human normal immunoglobulins may cause an anaphylactic shock. Tabulated list of adverse reactions The following adverse reactions have been reported in the context of 4 810 subcutaneous applications of Zutectra during four completed clinical trials and 1 006 applications during a non-interventional post authorisation safety study (PASS). The adverse reactions reported in four trials are summarised and categorised according to the MedDRA system organ class and frequency below. Frequency per injection has been evaluated using 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). Within each frequency grouping the adverse reactions are presented in order of decreasing seriousness. MedDRA System Adverse reactions Frequency Organ Class Infections and infestations Nasopharyngitis Rare* Immune system disorders Hypersensitivity Rare* Nervous system disorders Headache Uncommon Cardiac disorders Palpitations, cardiac discomfort Rare* Vascular disorders Hypertension Rare* Respiratory, thoracic and Oropharyngeal pain Rare* mediastinal disorders Gastrointestinal disorders Upper abdominal pain Uncommon 5 Skin and subcutaneous tissue Pruritus, rash Rare* disorders Musculoskeletal and connective Muscle spasms Rare* tissue disorders General disorders and Injection site pain, injection site Common administration site conditions urticaria, injection site haematoma, injection site erythema Fatigue, tiredness Rare* * single case reports Adverse reactions observed with other human immunoglobulin preparations With human normal immunoglobulins adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain m

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HOS-095424 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to human immunoglobulins. In particular, in very rare cases of IgA deficiency when the patient to be treated has antibodies against IgA. Zutectra must not be administered intravascularly.

HOS-095423 · has-indication-information · PDF-Seite 2

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re- infection prophylaxis.

HOS-095426 · has-interaction-information · PDF-Seite 4

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. 4 Human hepatitis B immunoglobulin should be administrered 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.

HOS-095427 · has-pregnancy-information · PDF-Seite 5

Pregnancy 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. 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. Breast-feeding The safety of this medicinal product for use in breast-feeding has not been established in controlled clinical trials and therefore should only be given with caution to breast-feeding mothers. Fertility No fertility studies have been performed (see section 5.3).

HOS-095425 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. This recommendation applies also for documentation in a treatment diary during self-administration of the medicinal product in a home treatment. 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. Hypersensitivity True hypersensitivity reactions are rare. 3 Zutectra contains a small quantity of IgA (see section 2). 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 initially injecting the product slowly; - are carefully monitored for any symptoms throughout the injection. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous injection should be monitored during the first injection and for the first hour after the first injection, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the treatment. In case of shock, standard medical treatment for shock should be implemented. 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 direct a

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