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Logo POLIORAL

BIOCINE SCLAVO

POLIORAL
Oral Polio Vaccine (Sabin Strains)
Stabilized with MgCl2 1M

Description/Composition: The oral
poliomyelitis vaccine (OPV) is a trivalent vaccine containing suspension of types 1, 2 and 3 of attenuated poliomyelitis viruses (Sabin Strains), grown in monkey kidney cell cultures. Each dose contains not less than:
1,000,000 infective units of Type 1
100,000 infective units of Type 2
600,000 infective units of Type 3
Magnesium Chloride is used as stabilizer.
The vaccine fulfills WHO requirements for Poliomyelitis Vaccine (Oral).

Administration: OPV must only be administered ORALLY.
Two drops are delivered directly into the mouth from the multi-dose dispenser. For older children it may be preferred to avoid the possible bitter taste by first placing the drops on a sugar lump or in syrup. Care should be taken not to contaminate the multi-dose dispenser with saliva of vaccinee.
Once a dispenser has been opened, it should be used the same day, and then only if it has been maintained between 0°C and +8°C.

Immunization Schedule: Infants should receive at least three doses of OPV at minimum intervals of 4 weeks. In non-endemic areas the first dose can be given from 6 weeks with the first dose of DPT. In endemic areas, an extra dose should be given as soon as possible after birth.
OPV can be given safely and effectively at the same time as measles, DPT, DT, TT and BCG vaccines.

Precautions: Polioral is a liquid preparation either red or pink coloured, which may change to yellow or to purple but remaining always clear. The vaccine should not be used if turbidity is noted on thawing or standing.

Side Effects: In the vast majority of cases there are no side effects. Very rarely there may be vaccine associated paralysis (less than one case per 3 million doses administered).

Contraindications
The vaccine should not be administered to those with an immune deficiency. No adverse effects are produced by giving OPV to a sick child. However, if in doubt, for instance during diarrhoea, a repeat dose can be given after recovery.
HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTED PERSONS: HIV infected persons, both asymptomatic and symptomatic, should be immunized with OPV according to standard schedules.

Storage: The vaccine should be kept frozen at –20°C or below. Under these conditions it retains its potency for at least 2 years.
When kept at a temperature between 0°C and +4°C, it retains its potency for 6 months. When exposed to higher temperatures it deteriorates rapidly, at about +25°C may be expected to loose its potency within two weeks. Repeated thawing and freezing should be avoided. Protect from light.

        How Supplied: The vaccine comes in monodose and multidose plastic dispensers.

        BIOCINE SCLAVO S.p.A.
        Via Fiorentina, 1
        SIENA, ITALY        Rev. 5/94

        Manufacturing Plant
        SOVICILLE, (SIENA) ITALY        633505        IGP

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