(and dosage form):
DESCRIPTIVE/ NAME OF MEDICINE:
Poliomyelitis Vaccine, Live, Oral, Trivalent (Sabin Strains)
A.30.1 Biologicals Antigen
Polioral is an aqueous preparation of attenuated, live, poliovirus type 1, 2 and 3 grown in cultures of monkey kidney tissue. The virus concentrations per dose (2 drops) are as follows:
1 000 000 C.C.I.D.50 of Type 1 (strain L Sc 2 ab)
100 000 C.C.I.D.50 of Type 2 (strain P 712, Ch 2 ab)
600 000 C.C.I.D.50 of Type 3 (strain Leon 12 a1 b)
The vaccine is stabilised with 1 M MgCl2.
Polioral is a liquid preparation either red or pink coloured, which may change to yellow or to purple but remaining always clear.
PHARMACOLOGICAL ACTION OF THE MEDICINE:
Active immunisation against poliomyelitis types 1, 2 and 3.
Immunosupression resulting from treatment or disease.
Should not be given to contacts of immunosuppressed patients.
Administration of Polioral should be delayed in persons suffering acute febrile illnesses, debilitating ailment, abdominal pain, diarrhoea or other intestinal disorders. Diarrhoea should not be considered a contra-indication to OPV, but to ensure full protection, doses given to children with diarrhoea should not be counted as part of the series and the child should be given another dose at the first available opportunity. Warning: Do not administer parenterally. The vaccine should not be used if turbidity is noted on thawing or standing.
DOSAGE AND DIRECTIONS FOR USE:
Trivalent oral polio vaccine is given at birth, 6-. 10-, 14-weeks and 18 months. A booster dose is given at 5 years (pre-school age).
Administration: OPV must be administered orally. Thaw and shake well before using. Two drops are delivered directly into the mouth from the multi-dose dispenser. Care should be taken not to contaminate a multi-dose dropper with saliva of the 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.
Instruction for use: Turn the wing shaped cap in a clock-wise direction to perforate the plastic dispenser. Unscrew the cap, hold the dispenser vertically downwards and squeeze it to expel the vaccine drop by drop.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Fever, Malaise and headache and allergic reactions may occur.
Measures to treat anaphylaxis including adrenalin must always be available.
Vaccine-associated poliomyelitis has been reported in a small number of recipients of oral polio vaccine and in contacts of recipients. Contacts of recently immunized babies and infants should be advised of the need for strict personal hygiene, particularly hand washing after napkin changing.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The vaccine is supplied in natural coloured plastic dispensers with green caps.
a) 1 x 1 dose plastic dispenser per carton;
b) 1 x 10 dose plastic dispenser per carton;
c) 10 x 10 dose plastic dispensers per carton;
d) 10 x 20 dose plastic dispensers per carton.
The vaccine should be stored frozen (20°C or below). Under these conditions it retains its potency for at least two years. When thawed and kept at a temperature between 0°C and 4°C it may be expected to retain its potency for six months. Repeated thawing and freezing should be avoided.
Once a multi-dose 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.
NAME AND ADDRESS OF APPLICANT:
Biovac S.A. c.c. , 1 Manchester Road, Wadeville, South Africa.
DATE OF PUBLICATION OF PACKAGE INSERT:
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