Imovax Polio

Imovax Polio

vaccine, poliomyelitis

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Inactivated poliomyelitis virus types 1, 2 and 3.
Description
One dose (0.5 mL) contains: Poliovirus# type 1, Mahoney strain (inactivated) 40 DU*+, Poliovirus# type 2 MEF-1 strain (inactivated) 8 DU*+, Poliovirus# type 3, Saukett strain (inactivated) 32 DU*+.
This vaccine is in compliance with European Pharmacopeia requirements and WHO recommendations.
#cultured on VERO cells.
*DU:D-antigen unit.
+or the equivalent antigenic quantity, determined by suitable immunochemical method.
Excipients/Inactive Ingredients: 2-phenoxyethanol, ethanol, formaldehyde, medium 199 Hanks (containing in particular amino acids, mineral salts, vitamins, glucose, polysorbate 80 and water for injections), hydrochloric acid or sodium hydroxide for pH adjustment.
Indications/Uses
Prevention of poliomyelitis in infants, children and adults, for primary vaccination and as a booster.
Dosage/Direction for Use
Primary Vaccination: Adult: For nonvaccinated adults, 2 successive injections of 0.5 mL must be given at intervals for one or, preferably two months.
Children from 2 months of age: 3 successive injections of 0.5 mL should be administered at intervals of one or two months. From 6 weeks of age: Imovax Polio may be administered following the 6, 10, 14-week schedule, as per the recommendations of the expanded programme on immunisation of the world health organisation.
Booster: Adult: A 3rd dose (1st booster) is administered 8 to 12 months after the 2nd injection. Children in the second year of life: a 4th dose (1st booster) is administered one year after the 3rd injection.
A booster is given every 5 years in children and adolescents and every 10 years in adults.
Administration: The preferred route of administration is intramuscular, though the vaccine may also be given subcutaneously.
The preferred site of intramuscular injection is the mild-lateral aspect of the thigh in infants and toddlers and the deltoid muscle in children, adolescents and adults.
If Patient Forget to take Imovax Polio: The physician will decide when to administer the missing dose.
Overdosage
If patient uses more Imovax Polio more than the patient should have: Not applicable.
Contraindications
Do not use Imovax Polio if patient or child is allergic to the active substances, to one of the excipients, to neomycin, to streptomycin or to polymyxine B or have had an allergic reaction following a previous injection of this vaccine. Have a fever or acute illness; in this case, vaccination should be postponed.
Special Precautions
Take Special Care with Imovax Polio if Patient or Child: Have thrombocytopenia (insufficient blood platelets, which play an important role in coagulation) or a bleeding disorder, because of the bleeding that can occur during intramuscular administration of the vaccine.
Are taking a treatment that suppresses immune responses or presenting with an immune deficiency disorder, in which case the immune response to the vaccine may be reduced. In such cases it is recommended to postpone vaccination until the end of the treatment or to make sure the subject is well protected. Vaccination of subjects with chronic immunodeficiency such as HIV infection, is nevertheless recommended even if the immune response might be limited by the underlying illness.
This vaccine may also be indicated for subjects for whom the oral vaccine is contraindicated and as a booster for subjects previously vaccinated with the oral vaccine.
Do not inject by the intravascular route: Make sure the needle does not penetrate a blood vessel.
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Use In Pregnancy & Lactation
This vaccine may be used during pregnancy, if required. Breastfeeding is not a contraindication.
Ask the physician or pharmacist for advice before taking any medicine.
Side Effects
Like all vaccines, Imovax Polio may cause side effects.
The Most Frequently Reported Side Effects are: Local reactions at the injection: Pain, erythema (skin redness), induration; moderate transient fever.
Other Side Effects, Reported Very Rarely (<0.01%), are: Local reactions at the injection site: Oedema that can occur within 48 hours and persist for one to two day; lymphadeopathy (increase in the size of lymph nodes). Hypersensitivity Reaction (Allergy): Urticaria, quincke's oedema (facial oedema), anaphylactic shock in response to one of the vaccine components.
Moderate and transient arthralgia (joint pain) and myalgia (muscular pain) in the days following vaccination.
Convulsions (isolated or associated with fever) in the following vaccination, headaches, moderate and transient paresthesia (a tingling sensation, primarily in the lower limbs) occuring in the two weeks following vaccination.
Agitation, somnolence and irritability in the first hours or days following vaccination and disappearing rapidly.
Widespread skin rash.
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccinations.
If patient notices any side effects not listed, please tell the physician or pharmacist.
Drug Interactions
There is no documented evidence against administration of Imovax Polio with other usual vaccines in a single vaccination session.
Caution For Usage
Do not use Imovax Polio if it has a cloudy appearance.
Storage
Store in refrigerator (between +2°C and +8°C). Protect from light. Do not freeze.
ATC Classification
J07BF - Poliomyelitis vaccines ; Used for active immunizations.
Presentation/Packing
Inj (pre-filled syringe) 0.5 mL x 1's, 20's.
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