POLIO SABIN ONE AND THREE (ORAL) VACCINE

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Virus Polio Type 1, strain LSc, 2ab; Virus Polio Type 3, strain Leon 12a, 1b

Disponible desde:

GLAXOSMITHKLINE PTE LTD

Código ATC:

J07BF04

formulario farmacéutico:

SUSPENSION

Composición:

Virus Polio Type 1, strain LSc, 2ab ≥10⁶·˚CCID₅₀; Virus Polio Type 3, strain Leon 12a, 1b ≥10⁵·⁸CCID₅₀

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricado por:

GlaxoSmithKline Biologicals SA

Estado de Autorización:

ACTIVE

Fecha de autorización:

2016-02-23

Ficha técnica

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[GSK Logo]
POLIO SABIN™ ONE AND THREE (ORAL)
BIVALENT ORAL POLIOMYELITIS VACCINE TYPES 1 AND 3 (LIVE, ATTENUATED)
QUALITATIVE AND QUANTITATIVE COMPOSITION
_POLIO SABIN™_
One and Three (oral) is a bivalent, live attenuated poliomyelitis
virus vaccine
of the Sabin strains Type 1 (LSc, 2ab) and Type 3 (Leon 12a, 1b),
propagated in MRC5
human diploid cells.
1 dose (0.1 ml) contains:
Virus Polio Type 1, strain LSc, 2ab
≥
10
6.0
CCID
50
Virus Polio Type 3, strain Leon 12a, 1b
≥
10
5.8
CCID
50
PHARMACEUTICAL FORM
Oral suspension.
The vaccine is presented as a clear liquid, yellowish-to pink
suspension for oral
administration.
CLINICAL PARTICULARS
INDICATIONS
_POLIO SABIN™_
One and Three (oral) is indicated for active immunisation in all age
groups
against infection caused by poliomyelitis viruses of Type 1 and 3.
DOSAGE AND ADMINISTRATION
POSOLOGY
In a multidose container, one immunising dose (0.1 ml) is contained in
two drops.
AS VACCINATION SCHEMES VARY FROM COUNTRY TO COUNTRY, THE ADVISED
SCHEDULE FOR EACH
COUNTRY MUST BE IN ACCORDANCE WITH THE NATIONAL RECOMMENDATIONS.
INFANTS:
The primary immunisation course is three doses of
_POLIO SABIN™_
One and Three
(oral) vaccine. The vaccine should be administered with an interval of
at least one month
between doses.
_POLIO SABIN™_
One and Three
(oral) may be given at birth provided it is realised that the
response is likely to be sub-optimal, and that three additional doses
will be required later in
life to give adequate protection.
CHILDREN AND ADULTS:
In order to maintain the level of protection against poliovirus
infection,
it is recommended to give a booster dose at the time of school entry
and again on leaving
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school and occasionally in adult life when a person is likely to be
exposed to a high risk of
infection, such as when travelling to endemic areas.
METHOD OF ADMINISTRATION
_POLIO SABIN™_
One and Three (oral) is for oral use only.
One dose of vaccine is contained in two drops which are delivered from
the polyethyle