Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
TETANUS TOXOID, DIPHTHERIA TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, PERTACTIN, FIMBRIAE TYPES, AND, ALUMINIUM PHOSPHATE
Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France
J07AJ52
ALUMINIUM PHOSPHATE 1.5 mg TETANUS TOXOID 20 IU DIPHTHERIA TOXOID 2 IU PERTUSSIS TOXOID 2.5 µg FILAMENTOUS HAEMAGGLUTININ (FHA) 5 µg PERTACTIN 3 µg FIMBRIAE TYPES 2 AND 3 5 µg
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
ALUMINIUM PHOSPHATE 1.5 mg TETANUS TOXOID 20 IU DIPHTHERIA TOXOID 2 IU PERTUSSIS TOXOID 2.5 µg FILAMENTOUS HAEMAGGLUTININ (FHA) 5 µg PERTACTIN 3 µg FIMBRIAE TYPES 2 AND 3 5 µg
POM
VACCINES
Authorised
2016-08-26
PAGE 1 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ADACEL 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 ADACEL is and what it is used for 2. What you need to know before ADACEL is given to you or your child 3. How and when ADACEL is given 4. Possible side effects 5. How to store ADACEL 6. Contents of the pack and other information 1 WHAT ADACEL IS AND WHAT IT IS USED FOR ADACEL (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 ADACEL 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 ADACEL 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. ADACEL 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 Perskaitykite visą dokumentą
PAGE 1 OF 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ADACEL, suspension for injection in pre-filled syringe. Diphtheria, 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. ADACEL appears as a cloudy white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADACEL (Tdap) is indicated for: Active immunization against tetanus, diphtheria and pertussis in persons from 4 years of age as a booster following primary immunization. PAGE 2 OF 15 Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.6, and 5.1). ADACEL 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 ADACEL 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 followed by a 3rd dose of a diphtheria or dT contai Perskaitykite visą dokumentą