Bivalent Oral Poliomyelitis Vaccine Bio Farma

Bivalent Oral Poliomyelitis Vaccine Bio Farma

Manufacturer:

Bio Farma

Distributor:

Biovalys

Marketer:

Biovalys
Full Prescribing Info
Contents
Live-attenuated, oral poliomyelitis vaccine (Sabin) types 1 & 3 (bOPV).
Description
The live types 1 & 3 oral polio vaccine (bOPV) is a bivalent vaccine containing suspensions of types 1 and 3 attenuated poliomyelitis viruses (Sabin strains) prepared in primary monkey kidney cell. Each dose (2 drops = 0.1 ml) contains not less than 106.0 infective units of type 1 and 105.8 of type 3. Sucrose is used as a stabilizer. bOPV may contain trace amounts of not more than 2 mcg erythromycin and not more than 10 mcg kanamycin.
Dosage/Direction for Use
ADMINISTRATION: bOPV must only be administered orally. Two drops are delivered directly into the mouth from the multidose vial by dropper or dispenser. Care should be taken not to contaminate a multidose dropper with saliva of the vaccinee.
Once opened, multi-dose vials should be kept between +2°C and +8°C.
Multi-dose vials of bOPV from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 4 weeks, provided that all of the following conditions are met (as described in the WHO policy statement: The use of opened multi dose vials in subsequent immunization sessions, WHO/V&B/00.09): The expiry date has not passed; The vaccines are stored under appropriate cold chain conditions; The vaccine vial septum has not been submerged in water; Aseptic technique has been used to withdraw all doses; The vaccine vial monitor (VVM), if attached, has not reached the discard point.
IMMUNIZATION SCHEDULE: Used for active immunization against poliomyelitis type 1 and 3. This vaccine can be used simultaneously with IPV. Infants should receive at least three doses of bOPV at minimum intervals of 4 weeks. WHO recommends the following schedule in endemic countries: Birth, 6, 10, 14 weeks. In non-endemic areas the first dose can be given from 6 weeks with the first dose of DTP.
Contraindications
Immune deficiency: Individuals infected with human immunodeficiency virus (HIV), both asymptomatic and symptomatic, should be immunized with bOPV according to standard schedules.
However, the vaccine is contraindicated in those with primary immune deficiency disease or suppressed immune response from medication, leukaemia, lymphoma, or generalized malignancy.
Special Precautions
In case of diarrhoea, the dose received will not be counted as part of the immunization schedule and it should be repeated after recovery.
Side Effects
In the vast majority of cases there are no side effects reported with the trivalent OPV, that includes the same bOPV component.
Very rarely, there may be vaccine-associated paralysis. Persons in close contact with a recently vaccinated child may very rarely be at risk of vaccine-associated paralytic poliomyelitis.
Caution For Usage
THE VACCINE VIAL MONITOR: Inner square lighter than outer circle.
If the expiry date has not been passed, USE the vaccine.
At a later time, inner square still lighter than outer circle.
If the expiry date has not been passed, USE the vaccine.
Discard point: Inner square matches colour of outer circle.
DO NOT use the vaccine.
Beyond the discard point: Inner square darker than outer ring.
DO NOT use the vaccine.
Vaccine Vial Monitors (VVMs) are part of the label on all bOPV supply through Temp Time. The colour dot which appears on the label of the vial is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the ring, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or of a darker colour than the ring, then the vial should be discarded.
Storage
Vaccine is potent if stored at not higher than -20° until the expiry date indicated on the vial.
It can be stored for up to six months between +2°C and +8°C.
The vaccine may present a colour varying from light yellow to light red, due to a slight variation of pH; however, this does not affect the quality of the vaccine.
ATC Classification
J07BF04 - poliomyelitis oral, bivalent, live attenuated ; Belongs to the class of poliomyelitis viral vaccines.
Presentation/Packing
Vaccine (oral) (vial) 1 mL (light yellow to light red) x 10's.
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