Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
DIPHTHERIA TOXOID
GLAXOSMITHKLINE PTE LTD
J07AJ51
30 iu/0.5 ml
INJECTION
INTRAMUSCULAR
Prescription Only
GLAXOSMITHKLINE BIOLOGICALS SA
1996-05-07
1 INFANRIX TM DIPHTHERIA (D), TETANUS (T), PERTUSSIS (ACELLULAR, COMPONENT) (PA) VACCINE QUALITATIVE AND QUANTITATIVE COMPOSITION _INFANRIX_ _TM_ 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_ _TM_ 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. PHARMACEUTICAL FORM Suspension for injection. CLINICAL PARTICULARS INDICATIONS _INFANRIX_ _TM_ is indicated for active primary immunisation against diphtheria, tetanus and pertussis from the age of 2 months onwards. _INFANRIX_ _TM_ is indicated as a booster dose for children 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 administered. As vaccination schemes vary from country to country, the schedule for each country may be Прочетете целия документ