Polio Sabin(Oral)

[SUMAN-SAJAN]

Polio Sabin(Oral)

1.Name of the medicinal product.
Polio Sabin (oral) is :
Poliomyelitis vaccine, live (oral)

2.Qualitative and quantitative composition

Polio Sabin vaccine is a established preparation of live attenuated poliomyelitis viruses of the Sabin strains type 1 (LSc, 2ab), type 2 (p712 ch, 2ab) and type 3 (Leon 12a, 1b) propagated in MRC5 human diploid cells.

3.Pharmaceutical form
Oral suspension


4.Clinical particulars

4.1 Therapeutic indications
Polio Sabin (oral) is indicated for active immunization of infants and susceptible children and adults against infection caused by polioviruses of type 1, 2, and 3.

4.2 Posology and method of administration

Posology

In a multidose container, one immunizing dose is contained in two drops. The drops are delivered from the special dropper supplied with the multidose glass vials or directly form the multidose plastic tubes.
Infants- Polio Sabin (oral) should be administered with an interval of at least one month between doses. In endemic countries it is given in 6, 10, 14 weeks. In non-endemic areas the first dose can be given from 6 weeks with the first dose of DPT.

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, such 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 that 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 vaccine has a bitterly salty taste, it may be given in syrup or on a lump of sugar, particularly when it is o be given in young children.
Care should be taken not to contaminate a multidose dropper with saliva of the vaccine.

4.3 Contraindications
-known systemic hypersensitivity to neomycin, polymycin or to any other components of the vaccine
-leukemia
-Lymphoma or generalized malignancy

No adverse effects are produced by giving OPV to a sick child. In case of diarrhea, the dose received will not be counted as part of the immunization schedule and it should be repeated after recovery.

special warnings and special precautions for use

- Should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhea or vomiting.
- In immunocompetent recipients previous vaccination with inactivated poliomyelitis vaccine is not a contra-indication.
- Should not be injected under any circumstances.


4.4 interaction with other medicaments and other forms of interaction
OPV can be given safely and effectively at the same time as measles, rubella, mumps, DPT, DT, TT, Td, BCG, hepatitis B, haemophilus influenza type b, yellow fever and vitamin A supplementation.

4.5 Use during pregnancy and lactation
Pregnancy
Vaccine should not be given to pregnant women unless they are exposed to a definite risk of infection with wild polioviruses.

Lactation
No known contraindication has been established.


4.6 undesirable effects
Fever
Vomiting
Diarrhea
Symptoms of paralytic poliomyelitis
Very rarely allergic reactions including anaphylactic reactions

4.7 overdose
Occasional reports of overdose have been received. Overdose has not resulted in ill effect.

4.8 special precautions for storage

The vaccine should be stored either between +2-+8 degree Celsius or at -20 degree Celsius
Exposure to sunlight should be avoided.
Store the vaccine, if possible, at temperatures of -20 degree Celsius or less since this halts deterioration in vaccine potency.


4.9 nature and contents of container

The vaccine is presented in plastic, tubes (multidose tubes containing 25 doses) or glass vials (multidose vials containing 10 doses or 20 doses).due to variation in pH the color may vary from light yellow to light red.

4.10 instructions for use, handling and disposal

Vaccines should be inspected visually for any particulate matter or discoloration prior to administration.


LETS MAKE NEPAL POLIO FREE.

-Suman