Land: Cypern
Språk: grekiska
Källa: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
NEISSERIA MENINGITIDIS A,ΠΟΛΥΣΑΚΧΑΡΊΤΗ, ΜΗΝΙΓΓΙΤΙΔΌΚΟΚΚΟΣ C,ΠΟΛΥΣΑΚΧΑΡΊΤΗ
SANOFI PASTEUR.
J07AH03
NEISSERIA MENINGITIDIS A,POLYSACCHARIDE, NEISSERIA MENINGITIDIS C,POLYSACCHARIDE
100MCG
POWDER & SOLVENT FOR SUSPENSION FOR INJECTION
8000000697 - NEISSERIA MENINGITIDIS A,POLYSACCHARIDE - 50 UG; 8000000698 - NEISSERIA MENINGITIDIS C,POLYSACCHARIDE - 50 UG
INTRAMUSCULAR USE, ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ
Με Ιατρική Συνταγή
MENINGOCOCCUS, BIVALENT PURIFIED POLYSACC. ANTIGEN
01 - 1 VIAL WITH POWDER AND 0.5ML DILUENT IN PRE-FILLED SYRINGE - 1 - VIAL - 900000301 - Εγκεκριμένο
POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE POWDER AND DILUENT FOR SUSPENSION FOR INJECTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED. Keep this leaflet until you have completed the vaccination schedule. You may need to read it again. Follow carefully the advice of your doctor or nurse. Ask your doctor or your nurse if you need more information or advice. Make sure you complete the full vaccination schedule. Otherwise you may not be fully protected _The active substances are: _polysaccharide of _Neisseria meningitidis _group A (50 micrograms for one dose of 0.5 mL) and polysaccharide of _Neisseria meningitidis _group C (50 micrograms for one dose of 0.5 mL). _The other ingredients are: _powder: monohydrate lactose. Diluent: sodium chloride, disodium phosphate dihydrate, monosodium phosphate and water for injection. MARKETING AUTHORIZATION HOLDER SANOFI PASTEUR 14 Espace Henry Vallée, 69007 Lyon – France MANUFACTURER SANOFI PASTEUR 14 Espace Henry Vallée, 69007 Lyon - France SANOFI AVENTIS Zrt - 1225 Budapest - Campona u. I. (Harbor park) - Hungary 1. WHAT POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE IS AND WHAT IT IS USED FOR This medicinal product is a vaccine in the form of powder and diluent for suspension for injection (1 or 10 doses of 0.5 mL). POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE is used to prevent diseases caused by the bacterium _Neisseria meningitidis _(meningococcus) group A or C in adults and in children from the age of two years. This vaccine helps your body create its own protection (antibodies) against this bacterium. Group A or C meningococcus may provoke serious and sometimes lethal infections, such as meningitis or septicaemia (generalised infection). This vaccine only protects against the meningococcal bacterium from groups A or C. It does not protect against other groups of meningococci or other organisms responsible for meningitis or septicaemia (generalised infection). 2. BEFORE YOU USE POLYSACCHARIDE MENINGOCOCCAL A+C VACCINE Do not use POLYSACCHARIDE MENINGOCOCCAL A+C VA Läs hela dokumentet
1 N AME OF THE MEDICINAL PRODUCT Polysaccharide Meningococcal A+C Vaccine Powder and diluent for suspension for injection in pre-filled syringe 2 Q UALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.5 ml) of reconstituted vaccine contains: Polysaccharide of _Neisseria meningitidis _group A ........................ 50 micrograms Polysaccharide of _Neisseria meningitidis _group C.......................... 50 micrograms For the excipients, refer to 6.1. 3 P HARMACEUTICAL FORM Powder and diluent for suspension for injection in pre-filled syringe 4 C LINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This vaccine is indicated for active immunisation against the invasive forms of serogroup A and C meningococcal infections in adults and in children from the age of two onwards (see section 4.4). The use of the MENINGOCOCCAL POLYSACCHARIDE A+C VACCINE should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children from the age of two years onwards: one single dose (0.5 mL) of reconstituted vaccine. Revaccination is indicated within 2 to 4 years according to the patient’s age at the time of the first dose, the risk of exposure, and the serogroup involved. Method of administration: The vaccine should be administered by intramuscular or subcutaneous route. Administration is generally done into the antero-lateral aspect of the thigh muscle in children up to the age of 12 months, and in the shoulder muscle after this age. This vaccine should in no circumstances be mixed with other vaccines or other medicinal products (see section 6.2). Separate syringes and separate injection sites should be used in case of concomitant injections. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any excipients of this vaccine or severe reaction after a previous injection of the vaccine. Vaccination should be postponed in case of high fever or acute illness. 4.4 WARNINGS AND SPECIAL PRECAUTIONS FOR USE Do not inject via the intravascular route: ensure that the needle does not pene Läs hela dokumentet