Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
PERTACTIN, PERTUSSIS TOXOID, POLIOVIRUS, INACTIVATED, TYPE, MAHONEY STRAIN, MEF, SAUKETT STRAIN, DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, TETANUS TOXOID
Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland
J07CA02
PERTACTIN 8 µg PERTUSSIS TOXOID 25 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) 25 µg TETANUS TOXOID
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
PERTACTIN 8 µg PERTUSSIS TOXOID 25 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) 25 µg TETANUS TOXOID
POM
VACCINES
Withdrawn
2006-08-14
IPV INFANRIX, SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING THIS VACCINE. • 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 your child. Do not pass it on to others. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What IPV Infanrix is and what it is used for 2. Before your child receives IPV Infanrix 3. How IPV Infanrix is given 4. Possible side effects 5. How to store IPV Infanrix 6. Further information 1. WHAT IPV INFANRIX IS AND WHAT IT IS USED FOR IPV Infanrix is a vaccine used as a booster dose to protect your child against 4 diseases: • DIPHTHERIA - a serious bacterial infection that mainly affects the airways and sometimes the skin. The airways become swollen causing serious breathing problems and sometimes suffocation. The bacteria also release a poison. This can cause nerve damage, heart problems and even death. • TETANUS - tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them. The bacteria release a poison. This can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine. • WHOOPING COUGH (PERTUSSIS) - a highly infectious illness that affects the airways. It causes severe coughing that may lead to problems with breathing. The coughing often has a ‘whooping’ sound. The cough may last for one to two months or longer. Whooping cough can also cause ear infections, chest infections (bronchitis) which ma Lesen Sie das vollständige Dokument
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT IPV Infanrix, suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 IU Tetanus toxoid 1 not less than 40 IU _Bordetella pertussis_ antigens Pertussis toxoid 1 25 micrograms Filamentous Haemagglutinin 1 25 micrograms Pertactin 1 8 micrograms Poliovirus (inactivated) 2 type 1 (Mahoney strain) 40 D-antigen unit type 2 (MEF-1 strain) 8 D-antigen unit type 3 (Saukett strain) 32 D-antigen unit 1 adsorbed on aluminium hydroxide,hydrated 0.5 milligrams Al 3+ 2 propagated in VERO cells For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. IPV Infanrix is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This vaccine is indicated for booster vaccination against diphtheria, tetanus, pertussis, and poliomyelitis diseases in individuals from 16 months to 13 years of age inclusive who have previously received primary immunisation series against these diseases. The administration of IPV Infanrix should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY A single dose of 0.5 ml should be administered. Page 2 of 9 IPV Infanrix may be administered to subjects who have previously received whole cell or acellular pertussis-containing vaccines, and oral live attenuated or injected inactivated poliomyelitis vaccines. (See also sections 4.8 and 5.1) Lesen Sie das vollständige Dokument