BCG VACCINE

País: Indonésia

Língua: indonésio

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

Unidades em pacote:

DUS, 50 VIAL @ 20 DOSIS + PELARUT

Data de autorização:

2022-11-25

Características técnicas

“On medical prescription only” Reg. No.: DKI1340300144A1
Imported by : PT Bio Farma (Persero)
Jl. Pasteur No. 28, Bandung, Indonesia
SII
BCG VACCINE
_(Freeze-Dried)_
Keloid and lupoid reactions may also occur at the site of injection
and such children should not be
revaccinated.
INFORMATION OF ANTI TUBERCULOSIS DRUGS
The Minimum Inhibitory Concentration (MIC) towards the _Mycobacterium
bovis_ BCG Moscow strain
361-I is indicated in below mentioned table.
The vaccine is intended to be injected strictly via the intradermal
route, avoiding the subcutaneous
route.
Skin testing with tuberculin is not generally carried out before
giving BCG, but when performed, those
who are found to be positive reactors need not be immunized.
The skin is stretched between thumb and forefinger and sterile needle
(25 G or 26 G) inserted bevel
upwards for about 2 mm into superficial layers of the dermis (almost
parallel with the surface). Raised
blanched bleb showing tips of hair follicles is a sign of correct
injection. The site of injection is at
insertion of the deltoid muscle into the humerus. Sites higher on the
arm are likely to lead to keloid
formation.
INTRADERMAL INJECTION TECHNIQUE
DOSAGE AND ADMINISTRATION :
INDICATIONS AND IMMUNIZATION SCHEDULE
CONTRAINDICATIONS AND PRECAUTIONS
The vaccination dose is 0.05 ml for children under one year of age
including the new born and 0.1 ml for
children over one year of age and adult of the reconstituted vaccine
given intradermally. The skin should
not be cleaned with antiseptic. The vaccine should be preferably given
with a tuberculin syringe or
25 G/26 G sterile needle and syringe.
BCG vaccine is contraindicated in hypogamma- globulinemia, congenital
immunodeficiency,
sarcoidosis, leukaemia, generalised malignancy, HIV infections or any
other disorder in which natural
immune response is alterted, as also those on immunosuppressive
therapy, corticosteroids,
radiotherapy. In chronic eczema or other dermatological disease, the
vaccine can be given in a healthy
area of the skin.
The dilu