País: Malta
Idioma: inglés
Fuente: 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
J07CA
DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg 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 TETANUS TOXOID
SUSPENSION FOR INJECTION
DIPHTHERIA TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) 8 µg 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 TETANUS TOXOID
POM
VACCINES
Withdrawn
2008-07-02
PACKAGE LEAFLET: INFORMATION FOR THE USER IPV-BOOSTRIX, SUSPENSION FOR INJECTION 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 muscle spasms, fits and even death. The mus Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pre-filled syringe: IPV-Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content) Vial: IPV-Boostrix suspension for injection 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 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pre-filled syringe: Suspension for injection in pre-filled syringe. Vial: Suspension for injection. 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). The administration of IPV-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. IPV-Boostrix may be administered from the age of three years onwards. The use of IPV-Boostrix may be considered during the third trimester of pregnancy. For the use of the vaccine before the third trimester of pregnancy, see section 4.6. IPV-Boostrix contains reduced content of diphtheria, tetanus and pertussi Leer el documento completo