Imovax Polio

Imovax Polio

vaccine, poliomyelitis

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig
Full Prescribing Info
Contents
Inactivated type 1, 2, 3 poliomyelitis vaccine.
Description
The active substances are: For one dose (0.5 ml): Poliovirus (inactivated) Type 1 (Mahoney strain)# 40 DU*+, Type 2 (MEF-1 strain)# 8 DU*+, Type 3 (Saukett strain)# 32 DU*+
This vaccine complies with European Pharmacopoeia requirements and WHO recommendations.
#produced on VERO cells.
*DU: D-antigen unit.
+ or equivalent antigenic quantity determined by a suitable immunochemical method.
The other ingredients are: 2-phenoxyethanol, ethanol, formaldehyde, medium 199 Hanks (containing in particular amino acids including phenylalanine, mineral salts, vitamins, glucose, polysorbate 80 and water for injections), hydrochloric acid or sodium hydroxide for pH adjustment.
Indications/Uses
IMOVAX POLIO is a vaccine. Vaccines are used to protect against infectious diseases.
When IMOVAX POLIO is injected, the body's natural defences develop a protection against those diseases.
The vaccine is indicated for the prevention of poliomyelitis in infants, children and adults, for primary vaccination (series of first vaccinations) and as a booster.
IMOVAX POLIO must be used according to effective local recommendations.
Dosage/Direction for Use
Dosage regimen compliant with French recommendations: Pediatric population: One dose at the age of 2 months and one dose at the age of 4 months, followed by a booster dose at the age of 11 months.
Non vaccinated adults: Two successive doses of 0.5 ml at an interval of two months, followed by a booster dose 8 to 12 months after the first injection.
Please refer to official recommendations for any further boosters.
Other dosage regimens: This vaccine must be used according to effective official recommendations.
In countries where a live Oral Poliomyelitis vaccine (trivalent, bivalent or monovalent OPV) is used in the routine immunisation programme, IMOVAX POLIO may be used in association (co-administration) or in sequential use with OPV), in accordance with official recommendations.
Missed Dose: If patient forgot to take a dose of vaccine, the doctor will decide when to administer this dose.
Method of administration: This vaccine will be administered by a healthcare professional, preferably into a muscle (intramuscular route) or under the skin (subcutaneous route).
This vaccine must never be administered into a blood vessel.
Injection into a muscle will be preferably performed in the upper side of the thigh in young children and in the upper of the arm in children, adolescents and adults.
Contraindications
Do not use IMOVAX POLIO if patient: is allergic (hypersensitive) to the active substances or to any of the other components of IMOVAX POLIO, to neomycin, to streptomycin or to polymyxin B.
Had an allergic reaction after a previous injection of IMOVAX POLIO or a vaccine containing the same substances.
Had fever or a disease which occurred suddenly, without warning (acute disease). Vaccination will have to be postponed.
Special Precautions
Take special care with IMOVAX POLIO if patient: have blood disorders such as a decrease in platelets (thrombocytopenia) or clotting disorders because of the risk of bleeding which may occur during intramuscular administration of the vaccine.
Is taking a treatment that suppresses the immune defences (corticosteroid drugs, cytotoxic drugs, radiotherapy or any other treatments likely to weaken the immune defences) or if present with immune deficiency (immunosuppression), 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.
Present with chronic immunodeficiency such as an infection with the AIDS virus (HIV). Vaccination is recommended even if the immune response may be limited.
Vaccination may also be recommended for subjects in whom the oral vaccine is contraindicated, and as a booster for subjects previously vaccinated with the oral vaccine.
If patients has doubts, talk to the doctor or pharmacist.
Driving and using machines: This vaccine is unlikely to have any effects on the ability to drive or to use machines. However, no studies on this topic were performed.
Use In Pregnancy & Lactation
This vaccine can be used during pregnancy, in high risk situations.
Breast feeding is not a contraindication.
Ask the doctor or pharmacist for advice before taking any medicine.
Adverse Reactions
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions: Serious allergic reactions (hypersensitivity reactions), although very rare, may occur after vaccination.
Usually the patient is still at the vaccination place.
If any of the symptoms described below occurs after the patient have left the place where he/she was vaccinated, contact the doctor or the emergency services IMMEDIATELY:
Skin eruption with itching (urticaria).
Sudden swelling of the face and neck and breathing difficulty (angioedema, Quincke's oedema).
Sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, acceleration of heart rhythm associated with respiratory disorders (anaphylactic reaction and shock).
Other side effects: If patient experiences any of the side effects described below, if it persists or if it worsens, contact the doctor or pharmacist.
Very common (may affect more than one in 10 people): Injection-site pain, Fever over then 38.1°C.
Common (may affect less than one in 10 people but more than one in 100 people): Injection-site redness.
Uncommon (may affect less than one in 100 people but more than one in 1000 people): Injection-site hardening (induration).
Reactions with a Not Known frequency (frequency which cannot be estimated because these reactions are reported very rarely): Agitation, somnolence and irritability in the first hour of days following vaccination, and disappearing rapidly.
Convulsions (isolated or associated with fever) in the days following vaccination, headache (cephalagia), moderated and transient tingling sensations (paresthesia) (mainly in lower limbs) occurring in the two weeks following vaccination.
Widespread skin eruption (rash).
Moderate and transient joint pain (arthralgia) and muscle pain (myalgia) in the days following vaccination.
Local injection-site reaction: Increase in size of lymph nodes (lymphadenopathy), swelling (oedema) that may occur in the 48 hours following vaccination and persisting one or two days.
Complementary information concerning particular populations: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur 2-3 days after vaccination.
Drug Interactions
There are no known risks of administering IMOVAX POLIO with other usual vaccines during the same vaccination session.
If patient is taking or have recently taken any other medicines, including those obtained without a prescription, tell the doctor or pharmacist.
Caution For Usage
The following information is intended for healthcare professionals only: Method of administration: Verify that the vaccine is clear and colourless. Do not use the vaccine if it has a cloudy appearance.
Administer preferably via the intramuscular (IM) route, or via the subcutaneous (SC) route.
Do not inject via the intravascular route: make sure the needle does not penetrate a blood vessel.
Storage
Store in a refrigerator (2°C-8°C) in order to protect from light. Do not freeze.
After first opening, the vaccine can be used for up to 28 days provided it is stored between 2°C-8°C.
Do not use IMOVAX POLIO if the product has a cloudy appearance.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
ATC Classification
J07BF03 - poliomyelitis, trivalent, inactivated, whole virus ; Belongs to the class of poliomyelitis viral vaccines.
Presentation/Packing
Inj (pre-filled syringe) 0.5 mL x 1's, (multidose vial) 0.5 mL x 1's.
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