Krajina: Cyprus
Jazyk: gréčtina
Zdroj: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
DIPHTHERIA TOXOID; POLIOMYELITIS VIRUS TYPE 3; TETANUS TOXOID; PERTUSSIS TOXOID(PT); FILAMENTOUS HAEMAGGLUTININ (FHA); POLIOMYELITIS VIRUS TYPE 2; POLIOMYELITIS VIRUS TYPE 1; HAEMOPHILUS INFL. TYPE B POLYS.CONJ.T.TOXOID
SANOFI PASTEUR. (0000010487) 14 ESPACE HENRY VALLEE, LYON, 69007
J07CA06
DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS
POWDER & SUSPENSION FOR SUSPENSION FOR INJECTION
DIPHTHERIA TOXOID (8000000804) 0IU; POLIOMYELITIS VIRUS TYPE 3 (8000000485) 32DU; TETANUS TOXOID (8000040440) 0IU; PERTUSSIS TOXOID(PT) (8000001811) 25MCG; FILAMENTOUS HAEMAGGLUTININ (FHA) (8000001813) 25MCG; POLIOMYELITIS VIRUS TYPE 2 (8000000484) 8DU; POLIOMYELITIS VIRUS TYPE 1 (8000000483) 40DU; HAEMOPHILUS INFL. TYPE B POLYS.CONJ.T.TOXOID (8000001810) 10MCG
INTRAMUSCULAR USE
Εθνική Διαδικασία
DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS
Νομικό καθεστώς: Με Ιατρική Συνταγή; 1 VIAL WITH POWDER AND 0.5ML SUSPENSION IN PRE-FILLED SYRINGE WITH 2 SEPARATE NEEDLES (230008801) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
ANNEX IIIB PACKAGE LEAFLET PENTAXIM, POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION IN PREFILLED SYRINGE. DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), POLIOMYELITIS (INACTIVATED) VACCINE AND _HAEMOPHILUS _TYPE B CONJUGATE VACCINE, ADSORBED READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GET YOUR CHILD VACCINATED. Keep this leaflet. You may need to read it again. If you have any further questions. If you have a doubt, ask your doctor or pharmacist. This medicine has been prescribed for your child only. Never pass it on to others. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See Section 4. WHAT IS IN THIS LEAFLET: 1. WHAT PENTAXIM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PENTAXIM 3. HOW TO USE PENTAXIM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PENTAXIM 6. FURTHER INFORMATION 1. WHAT PENTAXIM IS AND WHAT IT IS USED FOR Pentaxim is a vaccine. Vaccines are used to protect against infectious diseases. When PENTAXIM is injected, the body’s natural defences develop a protection against those disease. PENTAXIM is indicated to help protect your child against diphtheria, tetanus, pertussis, poliomyelitis and against invasive infections due to the _Haemophilus influenzae _type b bacterium (such as meningitis, blood poisoning, etc.) PENTAXIM is indicated in children from the age of 2 months. It does not protect against infections caused by other types of _Haemophilus influenzae _or against meningitis due to other micro-organisms. 1. WHAT YOU NEED TO KNOW BEFORE YOU USE PENTAXIM NEVER USE PENTAXIM: if your child is allergic (hypersensitive): - to any of the vaccine components (listed in Section 6. “What PENTAXIM” contains”), - to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present as traces), - to a pertussis vaccine (acellular or “whole cell”), if your child had an allergic reaction after a prev Prečítajte si celý dokument
1. NAME OF THE MEDICINAL PRODUCT PENTAXIM, POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION IN PREFILLED SYRINGE DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), POLIOMYELITIS (INACTIVATED) VACCINE AND HAEMOPHILUS TYPE B CONJUGATE VACCINE, ADSORBED 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution one dose (0.5 ml) contains: Diphtheria toxoid (1) ....................................................................................................................... ≥ 30 IU Tetanus toxoid (1) .......................................................................................................................... ≥ 40 IU _Bordetella pertussis _antigens: Pertussis toxoid (1) ............................................................................................................25 micrograms Filamentous haemagglutinin (1) ........................................................................................25 micrograms Poliomyelitis virus (inactivated) - type 1 (Mahoney strain) .................................................................................................... 40 DU (2) (3) (4) - type 2 (MEF-1 strain) .......................................................................................................... 8 DU (2) (3) (4) - type 3 (Saukett strain) ...................................................................................................... 32 DU (2) (3) (4) Polysaccharide of _Haemophilus influenzae _type b ..........................................................10 micrograms conjugated to the tetanus protein................................................................................ 18-30 micrograms (1) adsorbed on aluminium hydroxide, hydrate....................................................................... 0.3 mg Al 3+ (2) DU: D antigen unit. (3) or equivalent antigenic quantity determined by a suitable immunochemical method. (4) produced on VERO cells. PENTAXIM may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B (see S Prečítajte si celý dokument