Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Diphtheria toxoid; Tetanus toxoid
AJ Vaccines A/S
J07AM; J07AM51
Diphtheria toxoid; Tetanus toxoid
.
Suspension for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Tetanus vaccines; tetanus toxoid, combinations with diphtheria toxoid
Marketed
2007-02-02
_Version 4.2, 04/2021_ PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER DITEBOOSTER SUSPENSION FOR INJECTION, PRE-FILLED SYRINGE. 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, pharmacist or nurse. • 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. diTeBooster stimulates the body to produce antibodies against diphtheria and tetanus. This vaccine can be used to re-vaccinate children (5 years or older) and adults who have already received primary vaccination against diphtheria and tetanus. The vaccine is also used to vaccinate children (5 years or older) and adults who have missing, incomplete or unknown primary vaccination against diphtheria and tetanus. In case of deep and potentially contaminated wounds, the vaccine can also be used as prevention against tetanus and revaccination against diphtheria. 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 or your child are vaccinated with diTeBooster • if you are suffering from Đọc toàn bộ tài liệu
Health Products Regulatory Authority 17 January 2024 CRN00DQNP Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT diTeBooster, suspension for injection in pre-filled single-dose syringes.Diphtheria and tetanus vaccine (adsorbed, reduced antigen content). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains: Diphtheria Toxoid, purified 1 6.25 Lf / ≥2 IU Tetanus Toxoid, purified 1 6.25 Lf / ≥20 IU 1 adsorbed on aluminium hydroxide, hydrated (Al(OH)3) corresponding to 0.5 mg aluminium (Al 3+ ). The diphtheria and tetanus toxins, obtained from cultures of _Corynebacterium diphtheriae_ and _Clostridium tetani_, are purified and detoxified. No substances of human origin are used during the vaccine manufacture. The vaccine may contain traces of formaldehyde which is used during the manufacturing process (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection in pre-filled syringes. (Injection). Colourless or light yellow suspension of white/grey particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against tetanus and diphtheria in individuals from 5 years of age. Re-vaccination against diphtheria and tetanus, and primary immunisation in individuals with missing, incomplete or unknown primary immunisation. Tetanus prophylaxis in individuals from 5 years of age with tetanus prone injuries with simultaneous immunisation against diphtheria. The use of diTeBooster should be in accordance with official national recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology diTeBooster should be administered intramuscularly as a single dose of 0.5 ml for all ages. _Revaccination_ diTeBooster can be used for revaccination of individuals who are previously primary vaccinated against diphtheria and tetanus in accordance with national recommendations. A booster response can only be expected in individuals who have been primary vaccinated. Repeat vaccination against diphtheria and tetanus sh Đọc toàn bộ tài liệu