Ambirix · 4.3 Contraindications · 1

HOS-093448 · has-adverse-reaction-information · PDF-Seite 5

Summary of safety profile Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age. In 2 comparative trials in subjects aged 1-15 years, the incidences of local and general solicited symptoms after a two-dose regimen of Ambirix was overall similar to that seen with the three-dose combined vaccine containing 360 ELISA Units of HAV and 10 µg of HBsAg. The most commonly reported adverse reactions following Ambirix administration are pain and fatigue occurring in an approximated per dose frequency of 50% and 30% respectively. List of adverse reactions Local and general adverse reactions reported following primary vaccination with Ambirix were categorised by frequency. Adverse reactions reported are listed according to the following frequency: 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 5 The following adverse reactions were reported during clinical trials with Ambirix. • Clinical trial data Metabolism and nutrition disorders Very common: appetite lost Psychiatric disorders Very common: irritability Nervous system disorders Very common: headache Common: drowsiness Gastrointestinal disorders Common: gastrointestinal symptoms General disorders and administration site conditions Very common: fatigue, pain and redness at the injection site Common: fever, swelling at the injection site In addition, the following adverse reactions were reported during clinical trials with GlaxoSmithKline’s other combined hepatitis A and hepatitis B vaccines (given as a 3 or 4 dose schedule). Infections and infestations Uncommon: upper respiratory tract infection Blood and lymphatic system disorders Rare: lymphadenopathy Nervous system disorders Uncommon: dizziness Rare: paraesthesia Vascular disorders Rare: hypotension Gastrointestinal disorders Common: diarrhoea, nausea Uncommon: vomiting, abdominal pain* Skin and subcutaneous tissue disorders Rare: pruritus, rash Very rare: urticaria Musculoskeletal and connective tissue disorders Uncommon: myalgia Rare: arthralgia General disorders and administration site conditions Common: malaise, injection site reaction Rare: chills, influenza like illness * refers to adverse reactions observed in clinical trials performed with the paediatric formulation •

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HOS-093444 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or neomycin. Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines. As with other vaccines, the administration of Ambirix should be postponed in subjects suffering from acute severe febrile illness. 3

HOS-093443 · has-indication-information · PDF-Seite 2

Ambirix is indicated in non-immune children and adolescents from 1 year up to and including 15 years of age for protection against hepatitis A and hepatitis B infection. Protection against hepatitis B infections may not be obtained until after the second dose (see section 5.1). Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course. - It is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.

HOS-093446 · has-interaction-information · PDF-Seite 4

No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated. However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins there was no effect on seroconversion rates. Concomitant immunoglobulin administration may result in lower antibody titres. When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b 4 vaccine (DTPa-IPV+Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1). Concomitant administration of Ambirix and other vaccines than those listed above has not been studied. It is advised that Ambirix should not be administered at the same time as other vaccines unless absolutely necessary. Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.

HOS-093447 · has-pregnancy-information · PDF-Seite 5

Pregnancy Ambirix can be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus. Breast-feeding Ambirix should only be used during breast-feeding when the possible advantages outweigh the potential risks. Fertility No fertility data are available.

HOS-093445 · has-warning-information · PDF-Seite 4

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reactions following the administration of the vaccine. Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination. It is not known whether Ambirix will prevent hepatitis A and hepatitis B in such cases. The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver. Ambirix is not recommended for postexposure prophylaxis (e.g. needle stick injury). If rapid protection against hepatitis B is required, the standard three-dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended. This is because, a higher proportion of subjects are protected in the interval between the second and third dose of the three-dose combined vaccine, than after a single dose of Ambirix. This difference is no longer present after the second dose of Ambirix (see section 5.1 for seroprotection rates). It is recommended that the two-dose regimen of Ambirix be completed prior to start of sexual activity. The vaccine has not been tested in patients with an impaired immune system. In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course. Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided. However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects. Ambirix should under no circumstances be administered intravascularly. This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

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