Inactivated polio virus vaccine.
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 is in compliance with European Pharmacopoeia requirements and WHO recommendations.
#produced on VERO cells.
*DU: D-antigen Unit.
†or the equivalent antigenic quantity, determined by a suitable immunochemical method.
Excipients/Inactive Ingredients: 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.
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.
This vaccine is indicated for the prevention of poliomyelitis in infants, children and adults, for primary vaccinated (series of first vaccinations) and as a booster.
IMOVAX POLIO must be used according to effective official recommendations.
Dosage: 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 adult: Two successive doses of 0.5ml 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 immunization programme, IMOVAX POLIO may be used in association (co-administration) or in sequential use with OPV), in accordance with official recommendations.
OR: Primary vaccination: 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.
For nonvaccinated adults, 2 successive injections of 0.5 ml must be given at intervals of one or, preferably, two months.
Booster: In children in the second year of life, a 4th dose (1st booster) is administered one year after the 3rd injection.
For adults, a 3rd dose (1st booster) is administered 8 to 12 months after the 2nd injection.
A booster is given every 5 years in children and adolescents and every 10 years in adults.
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 preformed in the upper side of the thigh in young children and in the upper part of the arm in children, adolescents and adults.
If the patient forgets to take IMOVAX POLIO: If the patient forgot to take a dose of vaccine, the doctor will decide when to administer the dose.
For any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not use IMOVAX POLIO if the 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.
Take special care with IMOVAX POLIO if the patient: Has blood disorders such as 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 the patient presents with an 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 with 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.
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.
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 as follows occurs after leaving the place where the vaccination happened, 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 the patient experiences any of the side effects described as follows, 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 than 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 or days following vaccination and disappearing rapidly; Convulsions (isolated or associated with fever) in the days following vaccination, headaches (cephalalgia), moderate 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 muscular 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 for 2-3 days after vaccination.
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacists or nurse. This includes any possible side effects not previously listed. By reporting side effects, the patient can help provide more information on the safety of this medicine.
There are no known risks of administering IMOVAX POLIO with other usual vaccines during the same vaccination session.
If the patient is taking or has recently taken any other medicines, including those obtained without a prescription, tell the doctor or pharmacist.
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 medicine no longer required. These measures will help to protect the environment.
The following information is intended for healthcare professionals only: For syringes without attached needles, the needle must be fitted firmly to the syringe, rotating it by a one quarter turn.
Verify that the vaccine is clear and colorless. 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.
Store in a refrigerator (2°C-8°C) in order to protect from light. Do not freeze.
J07BF03 - poliomyelitis, trivalent, inactivated, whole virus ; Belongs to the class of poliomyelitis viral vaccines.
Susp for inj (pre-filled syringe) (clear and colorless) 1 dose (0.5 mL) x 1's.