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Logo POLIO SABIN™ (oral)

POLIO SABIN™ (oral)

QUALITATIVE COMPOSITION:
POLIO SABIN (oral) vaccine is a stabilised preparation of the live attenuated poliomyelitis virus of the Sabin strain type 1 (LS-c, 2ab).

The virus is propagated in primary monkey kidney tissue culture.

POLIO SABIN (oral) meets the World Health Organisation requirements for biological substances and for
poliomyelitis vaccine (oral).

CLINICAL PARTICULARS:
Therapeutic indications:
POLIO SABIN (oral) is indicated for active immunisation of infants and susceptible children and adults against infection caused by poliovirus of type 1.

Posology and method of administration:
Posology:
In a multidose container one immunising dose is contained in two drops. The drops are delivered from the special dropper supplied with the multidose glass vials.

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 (oral) vaccine. They should be administered with an interval of at least one month.

POLIO SABIN (oral) may be given at birth provided it is realised that the take rate is likely to be lower, and that three additional doses are required later in life to give adequate protection.

Children and adults: In order to maintain the level of protection against polio virus infection, it is recommended to give a booster dose at the time of school entry and again on leaving school and occasionally in adult life when a person is likely to be exposed to a high risk of infection, as when travelling to endemic areas.

Method of administration:
POLIO SABIN (oral) is for oral use only.

The vaccine may be administered directly or mixed with beverages or foods provided these do not contain substances that may inactivate polioviruses, such as preservatives. Suitable vehicles are simple syrup, milk, bread and a lump of sugar. Since the magnesium chloride stabilised vaccine has a bitter salty taste, it may be given in syrup or on a lump of sugar, particularly in young children.

POLIO SABIN(oral) should under no circumstances be injected.

CONTRA-INDICATIONS:
As with other vaccines, the administration of POLIO SABIN (oral) should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhoea or vomiting. The presence of a minor infection, however, is not a contra-indication for immunisation. POLIO SABIN (oral) should not be administered to subjects suffering from primary and secondary immunodeficiencies. For those persons it is recommended to use the enhanced inactivated polio vaccine (elPV).

However, according to the Expanded Programme on Immunization (EPI) recommendations symptomatic and asymptomatic in infection with human immunodeficiency virus does not contraindicate immunisation with POLIO SABIN (oral).

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE:
Whenever POLIO SABIN (oral) is administered to an individual, it is a good clinical practice to offer immunisation to presumably susceptible close contacts (such as unvaccinated parents) at the same time because of the risk (although very small) of vaccine-contact paralytic poliomyelitis disease.

Contacts of recent vaccinees should be advised to observe personal hygiene. POLIO SABIN (oral) is recommended for epidemic control. It should be realised that the vaccine may not prevent or modify disease in those already infected with a wild type poliovirus.

The vaccine will not prevent infection caused by other agents such as poliovirus of type 2 and type 3.

Diarrhoea or vomiting (including gastro-intestinal infections) may interfere with the replication (“take”rate) of the POLIO SABIN (oral) vaccine.

Care should be taken not to contaminate a multidose dropper with saliva of a vaccinee.

Interaction with other medicaments and other forms of interaction:
POLIO SABIN (oral) has been administered at the same time as vaccines of the EPI (DPT, BCG, measles and Hepatitis B vaccines).

The vaccine can also be administered at the same time as the injectable measles, mumps and rubella vaccines if this fits conveniently in an immunisation schedule and with vaccines containing poliovirus of type 2 and type 3. Otherwise, there should be an interval of at least one month between the administration of two different live attenuated virus vaccines. Previous vaccination with IPV is not a contra-indication for the use of POLIO SABIN (oral).

Pregnancy and lactation:
Although there is no evidence that the live attenuated poliovirus has an adverse effect on the foetus, in accordance with general principles the vaccine should not be given to pregnant women unless they are exposed to a definite risk of infection with wild polioviruses. The effect on breastfed infants of the administration of POLIO SABIN (oral) to their mothers has not been evaluated in clinical studies. No contra-indication has been established.

Undesirable effects:
Non-specific signs and symptoms such as headache, vomiting and diarrhoea have been described after immunisation, but none have been recognised as caused by the vaccine. Temporal association between immunisation with POLIO SABIN (oral) and the development of signs and symptoms of paralytic poliomyelitis has been observed in vaccinees and susceptible close contacts. The frequency of this association is however extremely low. Estimates vary between one case of vaccine-associated paralytic poliomyelitis in one to ten million vaccinees and susceptible close contacts.

PHARMACOLOGICAL PARTICULARS:
Relevant information for vaccines:
POLIO SABIN (oral) induces an asymptomatic infection which confers protection by producing local and systemic immunity against type 1 poliomyelitis virus.

PHARMACEUTICAL PARTICULARS
Shelf life:
The expiry date of the vaccine is indicated on the label and packaging.
Not completely used multidose containers should be immediately frozen as it has been shown that repeated freezing/thawing does not affect the vaccine’s potency.

SPECIAL PRECAUTIONS FOR STORAGE:
In order to preserve optimal potency of POLIO SABIN (oral), exposure of the vaccine to ambient (non-refrigerated) temperatures should be kept to a minimum and exposure to sunlight should be avoided.

Shipment should be done under refrigerated conditions, particularly in hot climates.

The vaccine should be stored in a refrigerator between +2°C and +8°C or in a freezer at -20°C. Freezing and thawing does not affect the titre of the vaccine.

When distribution or administration is not imminent, it is advisable to store the vaccine if possible at temperatures of -20°C or less since this halts deterioration in vaccine potency. If the vaccine has been accidentally exposed to high temperatures not exceeding the time and temperature limits indicated below, the expiry date no longer applies. It should preferably either be used immediately or stored at -20°C.

If it is thought that the temperature limits have been exceeded, the vaccine should be discarded or if economically justified, be re-tested for potency.

Additional information on the stability:
The following experimental data give an indication of the stability of the vaccines and are not recommendations for storage (see under special precautions for storage).
The magnesium chloride stabilised vaccine will maintain adequate immunogenicity for 18 months when kept in a refrigerator at +2°C to +8°C, for six weeks at +25°C and for three days at +37°C.

At -20°C, all formulations and presentations are very stable and no loss of potency has been observed over a period of more than five years.

Instructions for use/handling:
Vaccines should be inspected visually for any particulate matter and/or other coloration prior to administration.

Due to minor variation of its pH, POLIO SABIN (oral) may vary in colour from light yellow to light red. Changes of the colour of the vaccine within these ranges do not signify deterioration of the vaccine.

PRESENTATIONS:
10 dose glass vials supplied with a plastic dropper.

MANUFACTURER:
SmithKline Beecham Biologicals S.A.
rue de l’Institut, 89
B-1330 Rixensart, Belgium.
Telephone: +32 (0) 2 656 8111
Fax : +32 (0) 2 656 8000
Telex : 63251 SB BIO B

DISTRIBUTED/MARKETED BY:
SmithKline Beecham Pharmaceuticals (Pty) Limited
6 Carey Street Wynberg Ext. 6
2090
Johannesburg.

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