SII BCG VACCINE (FREEZE DRIED), 1 ML

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

BCG live

Dostupné z:

RADIANTAIRE SDN BHD

INN (Medzinárodný Name):

BCG live

Počet v balení:

50vial Vials

Výrobca:

SERUM INSTITUTE OF INDIA PRIVATE LIMITED

Súhrn charakteristických

In case of systemic or persistent local infection with BCG vaccine occurs, expert advice should be taken
for the necessary treatment. BCG Moscow strain 361 I is resistant to pyrazineamide.
SPECIAL CASE OF CHILDREN BORN TO HIV SEROPOSITIVE MOTHERS.
The obligatory passage of maternal antibodies of the lgG type through the placenta makes it impossible
to interpret the serology of the child until the age of about 9-10 months (persistence of the maternal
antibodies has been detected up to 14 months). It is therefore necessary to wait until the child has been
found to be seronegative, as determined by immuno-transfer (Western Blot) with the support, if
necessary, of techniques for detecting the viral genome, before confirming that the child is not
infected.
If the child is infected BCG vaccine is contraindicated irrespective of the child’s condition, given the
potential risk of development of “BCG-itis” in the vaccinated child. The advice of a specialized medical
team is required.
Neither absence of BCG scar formation nor negative PPD reaction is indicative of poor BCG uptake.
There is no need to repeat BCG inoculation in babies who do not develop BCG scar as advocated in the
guidelines of IAP 1996.
IMMUNE DEFICIENCY
The vaccine is contraindicated in individuals with cell-mediated immune deficiency.
Individuals known to be infected with human immunodeficiency virus (HIV), either non-symptomatic or
symptomatic, should NOT receive BCG vaccine.
DRUG INTERACTIONS AND OTHER INTERACTIONS
The BCG vaccine may be routinely given to any child exposed early to the risk of contact with the disease
(tuberculosis).
In order to avoid possible interactions between several medicinal products, any other ongoing
treatment should be systematically reported to your doctor.
There is no indication to vaccinate women during pregnancy. Breast feeding can continue despite
vaccination with BCG vaccine.
As a general rule, during pregnancy and breast feeding, it is always recommended to ask your doctor's
advice before using a medicinal produ