Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.3 · PDF-Seite 3

HOS-085922 · Präparat HOS-083226

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neomycin.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): neomycin (HOS-085923)

Gegenanzeigen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.3 · PDF-Seite 3

HOS-085924 · Präparat HOS-083226

Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.3 · PDF-Seite 3

HOS-085925 · Präparat HOS-083226

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.5 · PDF-Seite 4

HOS-085926 · Präparat HOS-083226

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.5 · PDF-Seite 4

HOS-085927 · Präparat HOS-083226

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.5 · PDF-Seite 4

HOS-085928 · Präparat HOS-083226

It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 5

HOS-085929 · Präparat HOS-083226

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 5

HOS-085930 · Präparat HOS-083226

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 5

HOS-085931 · Präparat HOS-083226

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 5

HOS-085932 · Präparat HOS-083226

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 5

HOS-085933 · Präparat HOS-083226

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 5

HOS-085934 · Präparat HOS-083226

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 5–6

HOS-085935 · Präparat HOS-083226

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 Uncommon Myalgia disorders Rare Arthralgia General disorders and administration Very common Pain and redness at the injection site, site conditions fatigue Common Swelling at the injection site, injection site reactions (such as haematoma, pruritus and bruising), malaise Uncommon 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: Infections and infestations Meningitis Blood and lymphatic system disorders Thrombocytopenia, thrombocytopenic purpura Immune system disorders Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness Nervous system disorders Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions Vascular disorders Vasculitis Skin and subcutaneous tissue disorders Angioneurotic oedema, lichen planus, erythema multiforme Musculoskeletal and connective tissue Arthritis, muscular weakness disorders General disorders and administration Immediate injection site pain site conditions Following widespread use of the monovalent hepatitis A and/or hepatitis B vaccines, the following undesirable events have additionally been reported in temporal association with vaccination: Nervous system disorders Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), optic neuritis General disorders and administration Stinging and burning sensation site conditions Investigations Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the paediatric formulation

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Twinrix Adult

Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). · Abschnitt 4.8 · PDF-Seite 6

HOS-085936 · Präparat HOS-083226

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.