Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin
GlaxoSmithKline Biologicals s.a.
J07AJ52
diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin
not less than 30IU/dose+ not less than 40IU/dose+ 25mcg/dose+ 25mcg/dose+ 8mcg/dose
suspenion for injection
0.5ml/dose pre-filled glass syringe and needle
Prescription
Registered
2016-06-08
Infanrix ™ Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa) vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION _Illfllllrix™_ contains diphtheria toxoid, tetanus toxoid and three purified pertussis antigens (pertussis toxoid (PT), filamentous hacmagglutinin (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 phaseI _Bordetel!a_ _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 ill saline. _[1lj"tlllri.\;?·lf_ 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 I11cgof FilA and 8 mcg of periactin. PHARMACEUTICAL FORM Suspension for injection. CLINICAL PARTICULARS Indications _Infanrix':_ is indicated for active primary immunisation against diphtheria, tetanus and pertussis from the age of2 months onwards. _In/tfllri.'.?1If_ is indicated as a booster dose for children who have previously been imrnunised with three or four doses of either DTPu vaccine or diphtheria, tetanus and ::Y11~.'~;~~!j _R~11N,~_ ~i~ .. _"0;"_ (DTPw) vacci ne. :,::"!P?:7;;}, , ~.u ...; _t·_ .s::t· ! _~_ _."_ _••r-_ Dosage and Administration . . .,,' '"" _.'_ _'~":pr/(}.5_ .;¥~ >- .~ 1 Posology "". . _'7d~j6'~;"_ The recommended dose (0.51111) of the vaccine must be administered. As vaccination schemes vary from country to country, the sch Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Infanrix' D1 Diphtheria (D). tetanus (T), pertussis (acellular, component) CPa) vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Illjanrix™colltains_ diphtheria toxoid, tetanus toxoid and three purified pertussis antigens [pertussis toxoid CPT), filamentous haemagglutinin (FHA) and 69 kiloDalton outer membrane protein (pertactin)J 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 1 _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. _Injanrixi"_ 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 (lU) of diphtheria toxoid, 40 LU of tetanus toxoid, 25 mcg ofPT, 25 I11cgof FHA and 8 I11cgof per lac tin. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications _fI~ra1l1L'CTj\/_ is indicated for active primary imrnunisation against diphtheria, tetanus and pertussis from the age of2 months onwards. _Infanrixi"_ is indicated as a booster dose for children who have previously been imrnunised with three or four doses of either DTPa vaccine or diphtheria, tetanus and whole-cell pertussis (DTP) . \ iCfc.UT~M(. \..~tl(t f~" UTLUG AOX1J "H.OU::AI.:R- • "OU W vaccine. *' ,.,' f ~r.¥£",n!4_ 4flEA ~ OtMt{' t,~ _e,_ H..2Af\ #J\ I'J J.3.y.~: ~ ',"-11 .::~., 1 .. . , ...:." .>~"'"• _",d9_ 4.2 DOS32:e and Administration _"r",,": ._ _. Les hele dokumentet