INFORMATION FOR HEALTH PROFESSIONALS
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POLIO SABIN (oral) vaccine is a magnesium chloride stabilised preparation of live attenuated polio viruses of the Sabin strains type 1 (LS-c, 2ab), type 2 (P712, Ch, 2ab) and type 3 (Leon 12ab).
The viruses are propagated in primary monkey kidney tissue cultures and each 0.135ml (3 drops) contains not more than 5IU (0.7mcg) neomycin sulphate.
POLIO SABIN (oral) meets the World Health Organisation requirements for biological substances and for poliomyelitis vaccine (oral).
The appropriate formulation should be chosen in accordance with national
recommendations.
For example:
Polio Sabin (oral) vaccine is indicated for active immunisation of infants and susceptible children and adults against infection caused by polio viruses of type 1, 2 and 3.
A monodose container consists of one immunising dose of 0.135ml (3 drops).
As vaccination schemes vary from country to country, the advised schedule for each country must be in accordance with the national recommendations.
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 is likely to be lower, and that three additional doses are required later in life to give adequate protection.
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.
POLIO SABIN (oral) is for oral use only.
The vaccine may be administered directly or mixed with beverages of 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.
POLIO SABIN is contraindicated in subjects with known systemic hypersensitivity to neomycin or to any other component of the vaccine, but a history of contact dermatitis to neomycin is not a contraindication.
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 contraindication for immunisation.
In general, 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 (eIPV).
However, according to the Expanded Programme on Immunisation (EPI) recommendations symptomatic and asymptomatic infection with human immunodeficiency virus does not contraindicate immunisation with POLIO SABIN (oral).
Whenever POLIO SABIN (oral) is administered to an individual, it is 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.
In some populations and groups of vaccinees lower seroconversion rates have been observed.
Due to various non-specific factors all three vaccine viruses may not replicate optimally in the gut of susceptible subjects, even after three doses of the POLIO SABIN (oral).
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.
Diarrhoea or vomiting (including gastrointestinal infections) may interfere with the replication ("take" rate) of the POLIO SABIN (oral).
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. 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 contraindication for the use of POLIO SABIN (oral).
Although there is no evidence that live attenuated polioviruses have 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 known contraindication has been established.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Non-specific signs and symptoms such as fever, malaise, 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.
Very rarely allergic reactions, including anaphylactoid reactions, have been reported.
Occasional reports of overdose have been received. Overdose has not resulted in ill-effect.
Not applicable.
Not applicable.
Preclinical safety data confirms with WHO recommendations.
POLIO SABIN (oral) induces an asymptomatic infection which confers protection by producing local and systemic immunity against the three types of poliomyelitis viruses.
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 refrigerator 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 up to ten times 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 of its potency.
If the vaccine has been accidentally exposed to high environmental temperatures not exceeding the time and temperature limits indicated below, the expiry date indicated when storage is between +2°C and +8°C no longer applies. It should preferably either be used immediately or stored at -20°C until administration.
If it is thought that the temperature limits (as indicated below) have been exceeded, the vaccine should, if economically justified, be retested for potency before use or otherwise be discarded.
Additional information on the stability
The following experimental data give an indication of the stability of the
vaccine 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 and +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.
The expiry date of the vaccine is indicated on the label and packaging.
After opening, monodose containers should be kept in a refrigerator and used within eight hours because of the possibility of contamination of the vaccine. If these conditions are not fulfilled, the vaccine should be discarded.
Vaccines should be inspected visually for any particulate matter or
discolouration 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.
Prescription Medicine.
POLIO SABIN (oral) is supplied in packs of 10 monodose tubes.
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert & Customs Street
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
ph (09) 367 2900
fax (09) 367 2506
23 October 2002
Ref: MDS Version 2 (Date of approval 11/01/1999)