País: Israel
Idioma: anglès
Font: Ministry of Health
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); PERTACTIN; PERTUSSIS TOXOID (PT); TETANUS TOXOID
GLAXO SMITH KLINE (ISRAEL) LTD
J07CA
SUSPENSION FOR INJECTION
DIPHTHERIA TOXOID NLT 30 IU; TETANUS TOXOID NLT 40 IU; PERTACTIN 8 MCG / 0.5 ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 25 MCG / 0.5 ML; PERTUSSIS TOXOID (PT) 25 MCG / 0.5 ML
I.M
Required
GLAXO SMITH KLINE BIOLOGICALS S.A
BACTERIAL AND VIRAL VACCINES, COMBINED
Infanrix is indicated as a booster dose for children 15 months to 7 years of age who have previously been immunised with three or four doses of either DTPa vaccine or diphtheria, tetanus and whole-cell pertussis (DTPw) vaccine. Active primary immunisation against diphteria, tetanus and pertussis from the age 2 months onward.
2012-01-31
העדוה העדוה לע לע הרמחה הרמחה עדימ ( עדימ ( ןולעב )תוחיטב ןולעב )תוחיטב אפורל אפורל ךיראת : 27.11.2012 םש רישכת תילגנאב : INFANRIX רפסמ םושיר : 104-10-28630 םש לעב םושירה GLAXOSMITHKLINE (ISRAEL) LTD : םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח WARNINGS AND PRECAUTIONS The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. ADVERSE REACTIONS Respiratory, thoracic and mediastinal disorders: Apnoea _[see section “Warnings and _ _Precautions” for apnoea in very premature _ _infants (≤ 28 weeks of gestation)_ Llegiu el document complet
250 250 _The format of this leaflet was determined by the Ministry of Health and its content _ _was checked and approved in April 2013_ INFANRIX ™ Diphtheria - Tetanus - acellular Pertussis Vaccine (DTPa) SCOPE TRADE NAME Infanrix™ FORMULATION AND STRENGTH Suspension for injection. Infanrix contains diphtheria toxoid, tetanus toxoid and three purified pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and 69 kiloDalton outer membrane protein (pertactin)] adsorbed onto aluminium salts. The diphtheria and tetanus toxins obtained from cultures of _ Corynebacterium _ _diphtheriae_ and _ Clostridium tetani_ are detoxified and purified. The acellular pertussis vaccine components (PT, FHA and pertactin) are prepared by growing phase I _ Bordetella pertussis_ from which the PT and FHA and pertactin are extracted, purified, and treated with formaldehyde; PT is irreversibly detoxified. The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine components are adsorbed on aluminium salts. The final vaccine is formulated in saline. Infanrix meets the World Health Organisation requirements for manufacture of biological substances and for diphtheria and tetanus vaccines. No substances of human origin are used in its manufacture. A 0.5 ml dose of the vaccine contains not less than 30 International Units (IU) of diphtheria toxoid, 40 IU of tetanus toxoid, 25 mcg of PT, 25 mcg of FHA and 8 mcg of pertactin. EXCIPIENTS Aluminium hydroxide, sodium chloride, water for injections. RESIDUES Formaldehyde Polysorbate 80 CLINICAL INFORMATION INDICATIONS Infanrix is indicated for active primary immunisation against diphtheria, tetanus and pertussis from the age of 2 months onwards. Infanrix is indicated as a booster dose for children 15 months to 7 years of age who have previously been immunised with three or four doses of either DTPa vaccine or diphtheria, tetanus and whole-cell pertussis (DTPw) vaccine. DOSAGE AND ADMINISTRATION POSOLOGY The recommended dose (0.5 ml) of the vaccine must be administ Llegiu el document complet