Страна: Мальта
Язык: английский
Источник: Medicines Authority
PERTACTIN, PERTUSSIS TOXOID, DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, TETANUS TOXOID
GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium
J07AJ52
DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg TETANUS TOXOID PERTUSSIS TOXOID 8 µg PERTACTIN 2.5 µg
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg TETANUS TOXOID PERTUSSIS TOXOID 8 µg PERTACTIN 2.5 µg
POM
VACCINES
Authorised
2008-07-02
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER BOOSTRIX, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Diphtheria, tetanus, and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START RECEIVING THIS VACCINE 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. - This vaccine has been prescribed for you or your child only. Do not pass it on to others. - If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Boostrix is and what it is used for 2. What you need to know before you or your child receive Boostrix 3. How Boostrix is given 4. Possible side effects 5. How to store Boostrix 6. Contents of the pack and other information 1. WHAT BOOSTRIX IS AND WHAT IT IS USED FOR Boostrix is a vaccine used as a booster dose in children from 4 years onwards, teenagers and adults to prevent three diseases: diphtheria, tetanus (lockjaw) and pertussis (whooping cough). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. • DIPHTHERIA: Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death. • TETANUS (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to caus Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 2 International Units (IU) (2.5 Lf) Tetanus toxoid 1 not less than 20 International Units (IU) (5 Lf) _Bordetella pertussis_ antigens Pertussis toxoid 1 8 micrograms Filamentous Haemagglutinin 1 8 micrograms Pertactin 1 2.5 micrograms 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.3 milligrams Al 3+ and aluminium phosphate (AlPO 4 ) 0.2 milligrams Al 3+ The vaccine may contain traces of formaldehyde which is used during the manufacturing process (see section 4.3). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Boostrix is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards (see section 4.2). Boostrix is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see sections 4.2, 4.6 and 5.1). The administration of Boostrix should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology A single 0.5 ml dose of the vaccine is recommended. Boostrix may be administered from the age of four years onwards. Boostrix should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines with reduced content of diphtheria, tetanus and pertussis antigens. Boostrix can be administered to pregnant women during the second or the third trimester in accordance with official recommendations (see sections 4.1, 4.6 and 5.1). Boostrix may also be administered to adolescents and adults with unknown vaccination status or Прочитать полный документ