Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
PERTACTIN, PERTUSSIS TOXOID, POLIOVIRUS, INACTIVATED, TYPE, MAHONEY STRAIN, MEF, SAUKETT STRAIN, DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, TETANUS TOXOID
GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium
J07CA02
PERTACTIN 2.5 µg PERTUSSIS TOXOID 8 µg POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg TETANUS TOXOID
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
PERTACTIN 2.5 µg PERTUSSIS TOXOID 8 µg POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg TETANUS TOXOID
POM
VACCINES
Authorised
2008-07-02
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER IPV-BOOSTRIX, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated) 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 IPV-Boostrix is and what it is used for 2. What you need to know before you or your child receive IPV-Boostrix 3. How IPV-Boostrix is given 4. Possible side effects 5. How to store IPV-Boostrix 6. Contents of the pack and other information 1. WHAT IPV-BOOSTRIX IS AND WHAT IT IS USED FOR IPV-Boostrix is a vaccine used as a booster dose in children from 3 years onwards, teenagers and adults to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough) and poliomyelitis (polio). 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 m Læs hele dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT IPV-Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) 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 Inactivated poliovirus type 1 (Mahoney strain)² 40 D-antigen unit type 2 (MEF-1 strain)² 8 D-antigen unit type 3 (Saukett strain)² 32 D-antigen unit 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.3 milligrams Al 3+ and aluminium phosphate (AlPO 4 ) 0.2 milligrams Al 3+ ² propagated in VERO cells The vaccine may contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process (see section 4.3). Excipients with known effect The vaccine contains para-aminobenzoic acid < 0.07 nanograms per dose and phenylalanine 0.0298 micrograms per dose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. IPV-Boostrix is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IPV-Boostrix is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards (see section 4.2). IPV-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 IPV-Boostrix should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 3 Posology A single 0.5 ml dose of the vaccine is recommended. IPV-Boostrix may be administered from the age of three years onwards. IPV-Boostrix Læs hele dokumentet