Twinrix Paediatric · 4.6 Fertility, pregnancy and lactation · 1

HOS-083305 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The safety profile presented below is based on data from approximately 800 subjects. The most commonly reported adverse reactions following Twinrix Paediatric administration are pain and redness occurring in a per dose frequency of 28.5% and 11.5% respectively. 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 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 Common Appetite lost Psychiatric disorders Common Irritability Nervous system disorders Common Drowsiness, headache Rare Hypoaesthesia*, paraesthesia*, dizziness Vascular disorders Rare Hypotension* Gastrointestinal disorders Common Gastrointestinal symptoms, nausea Uncommon Diarrhoea, vomiting, abdominal pain Skin and subcutaneous tissue disorders Uncommon Rash Rare Urticaria, pruritus* Musculoskeletal and connective tissue Uncommon Myalgia* disorders Rare Arthralgia* General disorders and administration Very common Pain and redness at the injection site 5  site conditions Common Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever ( 37.5°C) Rare Influenza like illness*, chills* Post-marketing surveillance The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines: Infection

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083301 · 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 Paediatric should be postponed in subjects suffering from acute severe febrile illness.

HOS-083300 · has-indication-information · PDF-Seite 2

Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.

HOS-083303 · has-interaction-information · PDF-Seite 4

No data on concomitant administration of Twinrix Paediatric 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. Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine. Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti- HBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs  10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone. Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically studied. It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric.

HOS-083304 · has-pregnancy-information · PDF-Seite 4

Pregnancy The effect of Twinrix Paediatrict 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. 4 The effect of Twinrix Paediatric 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 Paediatric 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 Paediatric is excreted in human breast milk. The excretion of Twinrix Paediatric in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Twinrix Paediatric should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the woman.

HOS-083302 · 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. It is possible that subjects may be in the incubation period of a HA or HB infection at the time of 3 vaccination. It is not known whether Twinrix Paediatric will prevent HA and HB 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 Paediatric 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, patients receiving immunosuppressive treatment or patients with an impaired immune system, the anticipated immune response may not be achieved after the primary immunisation course. Such patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail to demonstrate an adequate response. 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 Paediatric 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 Paediatric 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’. 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.