TYPHIM VI

Land: Indonesien

Sprache: Indonesisch

Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Wirkstoff:

TYPHOID VI POLYSACCHARIDE

Verfügbar ab:

AVENTIS PHARMA - Indonesia

INN (Internationale Bezeichnung):

TYPHOID VI POLYSACCHARIDE

Dosierung:

0.025 IU

Darreichungsform:

INJEKSI

Einheiten im Paket:

DUS, 1 SYRINGE @ 1 DOSIS (0,5 ML)

Hergestellt von:

SANOFI PASTEUR - France

Berechtigungsdatum:

2021-01-27

Fachinformation

POLYSACCHARIDE TYPHOID
VACCINE
TYPHIM VI
COMPOSITION
Each 0.5 mL immunizing dose contains:
- Typhoid Vi polysaccharide.............................0.025 mg
- Phenol (preservative).....................................maximum
1.250 mg
- Isotonic buffer solution : sodium chloride, disodium phosphate
dihydrate,
sodium
dihydrogen
phosphate
dihydrate,
water
for
injection
.........................................................q.s. 0.5 mL
PHARMACEUTICAL DOSAGE FORM
Solution for injection in pre-filled syringe
Clear colorless solution
Ready-to-use, single-dose, 0.5 mL syringe.
THERAPEUTIC INDICATIONS
This vaccine is based on a constituent (capsular antigen) of the
bacteria
which causes typhoid fever for person two years of age or older.
Typhoid fever prevention becomes effective approximately 2 to 3
weeks after injection and protection lasts around 3 years.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
RESTRICTED TO ADULTS AND CHILDREN OVER 2 YEARS OF AGE.
A single injection (0.5 mL) by the intramuscular or subcutaneous route
with protection lasts around 3 years.
If exposure to risk continues, revaccination will be performed every
3 years
Vaccination schedule is the same for children and for adults.
A successful extraction operation for one or more vaccine doses from a
multidose vial depends essentially on the quality of the handling.
METHOD OF ADMINISTRATION
If the vaccine is an adsorbed vaccine, the vial must first of all be
shaken
gently, to avoid foaming, but sufficiently to obtain a homogenous
mixture of the contents. Then, using a sterile syringe fitted with a
sterile needle, a single dose is withdrawn from the multidose vial,
after
disinfecting the outer surface of the vial stopper using a
disinfectant.
For the subsequent dose(s), the same operation should be repeated.
Between the different withdrawal operations and, in any case, within
not more than five minutes after the last dose withdrawn, the vial
should be replaced in a refrigerator to keep the product at its normal
storage temperature, i.e., between +2°C