Twinrix Adult · 4.8 Undesirable effects · 1

HOS-083233 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The safety profile presented below is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21 days schedule (n=320). The most commonly reported adverse reactions following Twinrix Adult administration with the standard 0, 1, 6 month schedule are pain and redness occurring in a per dose frequency of 37.6% and 17.0% respectively. In the two clinical trials in which Twinrix Adult was administered at 0, 7, 21 days, overall solicited general and local symptoms were reported with the same categories of frequency as defined below. After a fourth dose given at month 12, the incidence of systemic and local adverse reactions was comparable to that seen after vaccination at 0, 7, 21 days. In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines. Tabulated list of adverse reactions Frequencies are reported as: 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  System Organ Class Frequency Adverse reactions Clinical trials Infections and infestations Uncommon Upper respiratory tract infection Blood and lymphatic system disorders Rare Lymphadenopathy Metabolism and nutrition disorders Rare Decreased appetite Nervous system disorders Very common Headache Uncommon Dizziness Rare Hypoaesthesia, paraesthesia Vascular disorders Rare Hypotension Gastrointestinal disorders Common Gastrointestinal symptoms, diarrhoea, nausea Uncommon Vomiting, abdominal pain* Skin and subcutaneous tissue disorders Rare Rash, pruritus Very rare Urticaria Musculoskeletal and connective tissue Unco

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HOS-083229 · 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. The administration of Twinrix Adult should be postponed in subjects suffering from acute severe febrile illness.

HOS-083228 · has-indication-information · PDF-Seite 2

Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.

HOS-083231 · has-interaction-information · PDF-Seite 4

No data on concomitant administration of Twinrix Adult 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, no influence on seroconversion was observed although it may result in lower antibody titres. Although the concomitant administration of Twinrix Adult and other vaccines has not specifically been studied, it is anticipated that, if different syringes and other injection sites are used, no interaction will be observed. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.

HOS-083232 · has-pregnancy-information · PDF-Seite 4

4 Pregnancy The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats. This study did not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/fetal development, parturition or post-natal development. The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials. Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Adult on pregnancy or on the health of the fetus/newborn child. While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection. Breast-feeding It is unknown whether Twinrix Adult is excreted in human breast milk. The excretion of Twinrix Adult in milk has not been studied in animals. A decision on whether to continue/discontinue breast- feeding or to continue/discontinue therapy with Twinrix Adult should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Adult therapy to the woman.

HOS-083230 · has-warning-information · PDF-Seite 3

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. 3 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 Twinrix Adult 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. Twinrix Adult is not recommended for postexposure prophylaxis (e.g. needle stick injury). The vaccine has not been tested in patients with impaired immunity. In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine. Obesity (defined as BMI ≥ 30 kg/m2) has been observed to reduce the immune response to hepatitis A vaccines. A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Twinrix Adult. Additional doses may need to be considered for persons who do not respond or have a sub- optimal response to a course of vaccinations. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. 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 Twinrix Adult can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects (see section 4.2). Twinrix Adult should under no circumstan

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