solution for injection, suspension
vaccine against polio, inactivated
1. What Imovax Polio is and what it is used for
Imovax polio is a vaccine used to prevent infections caused by polioviruses.
The vaccine activates the body’s immune system to provide protection ( antibodies ) against polio.
2. What you need to know before using Imovax Polio
Do not use Imovax Polio
- if you or your child are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6).
- if you or your child have previously had a severe reaction after vaccination with Imovax polio or any other vaccine containing the same substances.
- if you have a high fever or an acute infection , the vaccination should be postponed. Mild infection is not a barrier to using the vaccine, but talk to your doctor first.
Warnings and cautions
Talk to your doctor or pharmacist before you or your child are vaccinated with Imovax Polio.
Imovax Polio may contain traces of neomycin, streptomycin, and polymyxin B used during vaccine manufacture. Tell your doctor if you or your child are allergic to any of these antibiotics.
Talk to your doctor before vaccination:
- if you or your child have a decrease in the number of platelets in the blood ( thrombocytopenia or any coagulation disorder as bleeding may occur after injection into a muscle.
- if you or your child has a weakened immune system, the effect of the vaccination may be worse.
Other medicines and Imovax Polio:
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Tell your doctor if you or your child use so-called immunosuppressive drugs as the effect of the vaccination may then be worse.
Imovax Polio can be given at the same time as other vaccines but at separate injection sites.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The vaccine should be given during pregnancy only when absolutely necessary.
No information is available on whether the vaccine passes into breast milk.
Driving and using machines
The vaccine has no known effects on the ability to drive and use machines.
Imovax Polio contains phenylalanine, ethanol and sodium
Imovax Polio contains 12.5 micrograms of phenylalanine per 0.5 ml dose. Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
Imovax Polio contains 2 mg alcohol ( ethanol ) per 0.5 mg dose . The amount in a dose of this medicine corresponds to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effects.
Imovax Polio contains less than 1 mmol sodium per dose, ie it is essentially ‘sodium-free.
3. How to use Imovax Polio
The vaccine is given as an injection, usually in the thigh of infants and young children and in the upper arm of older children, teenagers, and adults. One dose is 0.5 ml of vaccine.
Basic protection (basic immunization):
Achieved by giving 3 doses at an interval of 1-2 months, starting at 2-3 months of age or 2 doses at an interval of 2 months, starting at 3 months of age, and the third dose at 12 months of age.
Previously unvaccinated adults are given 2 doses at once or two-month intervals.
Booster vaccination:
The first booster immunization should be administered no earlier than 6 months after the third primary injection.
Administration of additional booster doses, e.g. when traveling to the polio-endemic area should be carried out in accordance with national recommendations for polio immunization.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects are local reactions at the injection site in the form of redness, pain and swelling, and fever.
The following side effects have also been reported:
Unknown frequency: Headache, rash, hives, hypersensitivity reaction, sometimes severe, mild and transient joint or muscle pain, and crawling, short-term seizures, febrile seizures, anxiety, drowsiness, irritability, lymph node disease.
Respiratory arrest ( apnea ) in premature babies (born in or before the 28th week of pregnancy).
Hypersensitivity reactions with symptoms such as itching, skin reactions, swelling ( edema ) and shortness of breath, anaphylactic reaction, or anaphylactic shock may occur after a vaccination. If this happens to you after you have left the doctor’s office, you must see a doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imovax polio
Keep out of sight and reach of children.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Store the syringe in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
| Inactivated poliovirus type 1 (Mahoney), | 40 D- antigen units |
| Inactivated poliovirus type 2 (Mef-1), | 8 D- antigen units |
| Inactivated poliovirus type 3 (Sackett), | 32 D- antigen units |
The other ingredients are 2-phenoxyethanol, ethanol, formaldehyde, Medium 199 without phenol red (is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components (including glucose ), with the addition of Polysorbate 80, diluted in water for injections, hydrochloric acid or sodium hydroxide are added for pH adjustment.
What the medicine looks like and contents of the pack
1, 10, and 20 pre-filled syringes with a needle.
1 and 20 pre-filled syringes without needles.
Marketing Authorisation Holder
Sanofi Pasteur Europe
14 Henry Vallée Space
69007 Lyon
France
Manufacturer
Sanofi Pasteur
1541, avenue Marcel Mérieux
F-69280 Marcy l’Etoile
France
Local representative:
Sanofi AB
Box 30052
104 25 Stockholm
Tel: +46 8-634 50 00