Download imovax polio

IMOVAX POLIO
Poliomyelitis Vaccine, Inactivated
Composition :
Each 0,5 ml immunizing dose contains :
− Inactivated poliovirus vaccine type 1 ..........................................40 Antigen D units
− Inactivated poliovirus vaccine type 2 ..........................................8 Antigen D units
− Inactivated poliovirus vaccine type 3 ..........................................32 Antigen D units
− 2 phenoxyethanol .........................................................................2-3 μl
− Formaldehyde ..............................................................................2-20 μg
During vaccine manufacturing process, verocell was used as growth media for polio
viruses. In verocell production porcine origin trypsin was used. In the stage and
purification this vaccine is free from trypsin.
Marketing Authorization Holder
Sanofi Pasteur SA
2, avenue Pont Pasteur 69007 Lyon-France
Indication
The prevention of poliomyelitis in immunocompromized infants and
immunocompromized children, their household contacts and individuals in whom oral
polio vaccine is contraindicated.
Contra-Indications
− Usual contraindications to any immunization : vaccination should be postponed in
those suffering from fever, acute disease or progressive chronic disease.
− Hypersensitivity subsequent to a previous injection of the vaccine.
− Acute febrile infectious disease : wait till the recovery
− True allergy to streptomycin.
Special warnings
Do not inject by the intravascular route. Ensure that the needle does not enter a blood
vessel. Immunosuppressive therapy or immunodeficiency may induce a diminished
antibody response to active immunization. In such cases, it is recommended that
vaccination be delayed until the end of treatment or that the protection level of the subject
be checked. Nevertheless, the vaccination of subjects with chronic immunodepression
such as HIV infection is recommended if the underlying pathology allows the induction
of an antibody response, even if limited.
Special precaution for use
Given that each dose may contain traces of neomycin, streptomycin and polymyxin B,
this vaccine should be used with caution in those individuals presenting with a
hypersensitivity to these antibiotics.
Pregnancy and lactation
Vaccination is not recommended in pregnant women, although to date no embryotoxic
effects have been reported.
In pregnant women exposed to a polio risk, vaccination should only be performed in
cases of necessity.
Breast feeding is not a contraindication.
Mode of Administration and Dosage
To be injected by subcutaneous or intramuscular route.
It is recommended to inject this vaccine as soon as 2 months old.
Primary immunization: 2 injections of 0,5 ml should be administered at interval of one
month and boosters one year after second injection.
Destroy the syringe after use.
Side Effects
Side effects are rare.
Local reactions at the injection site: pain, redness, induration and oedeme may occur
within the 48 hours following the injection and can last for one or two days. The
incidence and severity of local reactions can depend on the site and route of
administration as well as the number of doses previously received. Systemic reactions :
fever isolated or associated to myalgia, headache or lymphadenopathy.
Interaction with other medicinal product
No interaction with other, medicaments has been reported to date. IPV may be
administered during the same session with other usual vaccine associations.
Storage
Keep between +20C and +80C.
Do not freeze.
Package
1 pre filled syringe @ 1 doses, Reg. DKI0459702543A1
1 vial 5 ml 10 doses, Reg. DKI0459702543A2
1 vial 10 ml 20 doses, Reg. DKI0459702543A2
Imported by : PT Aventis Pharma, Jakarta Indonesia
Harus Dengan Resep Dokter