Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
DIPHTHERIA TOXOID, TETANUS TOXOID
Statens Serum Institute
J07AM51
DIPHTHERIA TOXOID, TETANUS TOXOID
Per Cent
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Tetanus vaccines
Authorised
2007-02-02
Package leaflet: Information for the user DITEBOOSTER Suspension for injection, pre-filled syringe. Suspension for injection, vial. Diphtheria and tetanus vaccine (adsorbed, reduced antigen content). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. ________________________________________________________________________ WHAT IS IN THIS LEAFLET 1. What diTeBooster is and what it is used for 2. What you need to know before you are vaccinated with diTeBooster 3. How you are vaccinated with diTeBooster 4. Possible side effects 5. How to store diTeBooster 6. Contents of the pack and other information 1 WHAT DITEBOOSTER IS AND WHAT IT IS USED FOR diTeBooster is a vaccine that provides protection against diphtheria and tetanus. This booster vaccine is used to vaccinate children (5 years or older) and adults who have already received primary vaccination against diphtheria and tetanus. 2 WHAT YOU NEED TO KNOW BEFORE YOU ARE VACCINATED WITH DITEBOOSTER YOU SHOULD NOT BE VACCINATED WITH DITEBOOSTER - If you are allergic to the active substances or any of the other ingredients in the vaccine (listed in section 6). - If you have experienced serious side effects following previous vaccinations. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you are vaccinated with diTeBooster - if you are suffering from any illness. In case of acute illness with fever the vaccination should be postponed - if you are receiv Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT diTeBooster, suspension for injection in pre-filled syringe. Diphtheria and tetanus vaccine (adsorbed, reduced antigen content). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose = 0.5 ml: Diphtheria Toxoid, purified 6.25 Lf / > 2 IU Tetanus Toxoid, purified 6.25 Lf / > 20 IU Aluminium hydroxide, hydrated, corr. to aluminium content 0.5 mg The diphtheria and tetanus toxins, obtained from cultures of _Corynebacterium diphtheriae _and _Clostridium tetani, _are purified and detoxified. The two toxoids are adsorbed to aluminium hydroxide. No substances of human origin are used during the vaccine manufacture. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection in pre-filled syringes. (Injection). Colourless suspension of white/ grey particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Re-vaccination of children ( 5 years of age) and adults who have previously received primary immunisation of at least 3 doses of diphtheria and tetanus vaccine. diTeBooster is not intended for primary immunisation against diphtheria and tetanus. The use of diTeBooster should be in accordance with official national recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In comparison with a vaccine for primary immunisation diTeBooster contains reduced amounts of diphtheria and tetanus antigens, and the vaccine should be administered in accordance with national official recommendations regarding the use of such vaccines. The necessary precautions for treatment of anaphylactic reactions should always be taken. Shake before use. diTeBooster should be administered intramuscularly as a single dose of 0.5 ml. At certain indications (for example haemorrhagic diathesis) diTeBooster can be administered de Soma hati kamili