Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Diphtheria toxoid; Tetanus toxoid; Pertussis toxoid; Filamentous haemagglutinin; Pertactin (prn); Fimbriae types 2 and 3
Sanofi Pasteur
J07AJ; J07AJ52
Diphtheria toxoid; Tetanus toxoid; Pertussis toxoid; Filamentous haemagglutinin; Pertactin (prn); Fimbriae types 2 and 3
0 international unit(s)
Suspension for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Pertussis vaccines; pertussis, purified antigen, combinations with toxoids
Not marketed
2016-06-03
PACKAGE LEAFLET: INFORMATION FOR THE USER TRIAXIS SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Diphtheria, Tetanus, Pertussis (acellular, component) Vaccine (adsorbed, reduced antigen(s) content) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS 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 . - This vaccine has been prescribed for you or for your child only. Do not pass it on to others. - If you or your child 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 TRIAXIS is and what it is used for 2. What you need to know before TRIAXIS is given to you or your child 3. How and when TRIAXIS is given 4. Possible side effects 5. How to store TRIAXIS 6. Contents of the pack and other information 1 WHAT TRIAXIS IS AND WHAT IT IS USED FOR TRIAXIS (Tdap) is a vaccine. Vaccines are used to protect against infectious diseases. They work by causing the body to produce its own protection against the bacteria that cause the targeted diseases. This vaccine is used to boost protection against diphtheria, tetanus and pertussis (whooping cough) in children from the age of 4 years, adolescents and adults, following a complete primary course of vaccination. Use of TRIAXIS during pregnancy allows protection to be passed on to the child in the womb to protect her/him from whooping cough during the first few months of life. LIMITATIONS IN THE PROTECTION PROVIDED TRIAXIS will only prevent these diseases if they are caused by the bacteria targeted by the vaccine. You or your child could still get similar diseases if they are caused by other bacteria or viruses. TRIAXIS does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects. Remember that no vaccine can provide complete, lifelong protection i read_full_document
Health Products Regulatory Authority 29 May 2023 CRN00DCX7 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Triaxis, suspension for injection in a pre-filled syringeDiphtheria, Tetanus, Pertussis (acellular component) Vaccine (adsorbed, reduced antigen(s) content) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 mL) contains: Diphtheria Toxoid Not less than 2 IU* (2 Lf) Tetanus Toxoid Not less than 20 IU* (5 Lf) Pertussis Antigens Pertussis Toxoid 2.5 micrograms Filamentous Haemagglutinin 5 micrograms Pertactin 3 micrograms Fimbriae Types 2 and 3 5 micrograms Adsorbed on aluminium phosphate 1.5 mg (0.33 mg Al 3+ ) * As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia. This vaccine may contain traces of formaldehyde and glutaraldehyde which are used during the manufacturing process (see sections 4.3 and 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Triaxis appears as a cloudy white suspension 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TRIAXIS (Tdap) is indicated for: Active immunization against tetanus, diphtheria and pertussis in persons from 4 years of age as a booster following primary immunization. Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.6, and 5.1). TRIAXIS should be used in accordance with official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology A single injection of one (0.5 mL) dose is recommended in all indicated age groups. In adolescents and adults with an unknown or incomplete diphtheria or tetanus vaccination status against diphtheria or tetanus, one dose of TRIAXIS can be administered as part of a vaccination series to protect against pertussis and in most cases also against tetanus and diphtheria. One additional dose of a diphtheria- and tetanus- (dT) containing vaccine can be administered one month later f read_full_document