국가: 사이프러스
언어: 그리스어
출처: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
HAEMOPHILUS INFLUENZAE TYP B POLYSACCHARID
SANOFI PASTEUR. (0000010487) 14 ESPACE HENRY VALLEE, LYON, 69007
J07AG01
HEMOPHILUS INFLUENZA B, PURIFIED ANTIG.CONJUGATED
10MCG/0.5ML
POWDER & SOLVENT FOR SOLUTION FOR INJECTION
HAEMOPHILUS INFLUENZAE TYP B POLYSACCHARID (8000031698) 10UG
INTRAMUSCULAR USE; ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ
Εθνική Διαδικασία
HEMOPHILUS INFLUENZA B, PURIFIED ANTIG.CONJUGATED
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL POWDER & 1 PRE-FILLED SYRINGE SOLVENT (930028801) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ACT-HIB 10 MICROGRAMS/0.5 ML, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE _HAEMOPHILUS _TYPE B CONJUGATE VACCINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5-mL dose of reconstituted vaccine contains: _Haemophilus influenzae _type b polysaccharide…………………………10 micrograms Conjugated to tetanus protein……………………………………………18 - 30 micrograms Act-HIB may contain traces of formaldehyde used during the manufacturing process (see section 4.3) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White powder in vial and colourless solvent in pre-filled syringe. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This vaccine is indicated for the prevention of _Haemophilus influenzae _type b invasive infections (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, etc.) in children from the age of 2 months. This vaccine does not protect against infections due to other types of _Haemophilus influenzae _or against meningitis of other origins. Under no circumstances can the tetanus protein contained in this vaccine be used to replace the usual tetanus vaccination. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION P o s o l o gy • Before 6 months of age, 3 successive doses of 0.5 ml administered one or two months apart, followed by a booster injection (fourth dose) one year after the third injection. • Between 6 and 12 months of age, 2 doses of 0.5 ml administered one month apart, followed by a booster injection (0.5 ml) at 18 months of age. • From 1 to 5 years of age, a single dose of 0.5 ml. For contact cases: in the event of a contact with a patient presenting with invasive _Haemophilus _ _influenzae _type b infection (family or childcare), vaccination should be implemented as per the appropriate age schedule according to the official recommendations. The index case must also be vaccinated. Method of admin 전체 문서 읽기