Package leaflet: Information for the user

IMOVAX POLIO, suspension for injection in pre-filled syringe
Inactivated poliomyelitis vaccine

Please read all of this leaflet carefully before the vaccine is administered, as it contains important information for you.

Keep this leaflet until the completion of the entire vaccination cycle, so that you can read it again if necessary.
If you have any further questions, please consult your doctor, nurse, or pharmacist.
This vaccine has been prescribed for a specific individual. Do not pass it on to others.
If any of the adverse reactions worsen, or if you experience any adverse reactions not listed in this leaflet, inform your doctor. See section 4.

Table of contents of the leaflet:

What IMOVAX POLIO is and what it is used for
Important information before using IMOVAX POLIO vaccine
How to use IMOVAX POLIO vaccine
Possible side effects
How to store IMOVAX POLIO vaccine
Contents of the pack and other information

1. What IMOVAX POLIO is and what it is used for

IMOVAX POLIO (IPV) is a vaccine. Vaccines are used to protect against infectious diseases.
After administration of IMOVAX POLIO vaccine, the immune system produces protection against polio.
The vaccine is used to prevent poliomyelitis (polio) in infants, children, adolescents, and adults, as part of primary vaccination and as a booster dose.
IMOVAX POLIO vaccine should be used in accordance with current official recommendations (National Immunization Program).

2. Important information before using IMOVAX POLIO vaccine

When not to use IMOVAX POLIO vaccine:

if there is an allergy (hypersensitivity) to any of the active substances or other components (listed in section 6), to neomycin, streptomycin or polymyxin B,
if an allergic reaction occurred after previous administration of IMOVAX POLIO or a vaccine containing the same substances,
if there is fever or an acute illness, vaccination should be postponed.

Warnings and precautions
Exercise special caution when using IMOVAX POLIO if:

blood disorders such as low platelet count (thrombocytopenia) or coagulation disorders are present, as there is a risk of bleeding following intramuscular injection,
the person is receiving treatment that reduces immunity (corticosteroids, cytotoxic drugs, radiotherapy, or any other procedures that may suppress the immune system) or if immunosuppression is present; in such cases, the immune response following vaccination may be reduced. In these cases, it is recommended to postpone vaccination until completion of treatment or ensure the patient is adequately protected,
chronic immunodeficiency such as HIV infection (AIDS) is present; vaccination is recommended even though the immune response may be limited.

This vaccine may also be indicated as a booster dose in individuals previously vaccinated with oral vaccine.
Fainting may occur after, or even before, any injection. Therefore, inform your doctor or nurse if you have previously experienced fainting after injections.
If you have any doubts, please contact your doctor or pharmacist.
IMOVAX POLIO and other medicines
There is no known risk associated with administering IMOVAX POLIO vaccine simultaneously with other standard vaccines.
You should inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Pregnancy and breastfeeding
The vaccine can be administered during pregnancy in situations of high risk of infection.
Breastfeeding is not a contraindication.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy, you should consult your doctor or pharmacist before using this vaccine.
Driving and operating machinery
It is unlikely that the vaccine affects the ability to drive or operate machinery. However, no studies have been conducted in this area.
IMOVAX POLIO contains phenylalanine, ethanol and sodium
IMOVAX POLIO vaccine contains 12.5 micrograms of phenylalanine in each 0.5 ml dose.
Phenylalanine may be harmful for patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body because the body cannot properly eliminate it.
IMOVAX POLIO vaccine contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The amount of alcohol in one dose of this vaccine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this vaccine will not cause noticeable effects.
IMOVAX POLIO vaccine contains less than 1 mmol of sodium per dose; therefore, the vaccine is considered "sodium-free".

3. How to use the IMOVAX POLIO vaccine

Dosage:
Children
The dosing schedule should be in accordance with current national recommendations (National Immunization Program).
After completion of the 6th week of life or after completion of the 2nd month of life: three consecutive doses of 0.5 ml of IMOVAX POLIO vaccine should be administered at intervals of one or two months, followed by a first booster dose 6 to 12 months after the last dose.
Subsequent booster doses (in children, adolescents and adults) should be administered in accordance with current national recommendations.

Adults
The dosing schedule should be in accordance with current national recommendations.
Below are the recommendations of the World Health Organization (WHO):
Unvaccinated adults: two consecutive doses of 0.5 ml of vaccine should be administered at an interval of 1 month, or preferably 2 months, followed by a first booster dose 6 to 12 months after the last dose.
Subsequent booster doses should be administered in accordance with current national recommendations.

Method of administration
The vaccine will be administered by a healthcare professional into the muscle (recommended) or under the skin.
This vaccine must never be administered into a blood vessel.
The recommended site for intramuscular injection is the upper part of the thigh in young children and the upper part of the deltoid muscle in children, adolescents and adults.

Missed dose of IMOVAX POLIO vaccine:
Your doctor will decide when a missed dose should be given.
If you have any further doubts regarding the use of this vaccine, consult your doctor, nurse or pharmacist.

4. Possible adverse reactions

Like any medicinal product, this vaccine may cause adverse reactions, although they do not occur in
everyone.
Severe allergic reactions:
Severe allergic reactions (hypersensitivity reactions), although very rare, may occur after
vaccination, usually while the patient is still at the vaccination site. If any of the symptoms listed
below occur after leaving the vaccination facility, seek medical attention IMMEDIATELY by contacting a doctor or emergency services:

Skin changes with itching (urticaria)
Sudden swelling of the face and neck and breathing difficulties (angioedema, Quincke's edema)
Sudden and severe malaise with a drop in blood pressure causing dizziness and loss of consciousness, accompanied by an increased heart rate and respiratory disturbances (anaphylactic reaction and shock).

Other adverse reactions:
If any of the following adverse reactions occur in a patient, persist or worsen, contact a doctor or pharmacist.
Very common (may affect more than 1 in 10 people):

Pain at the injection site
Fever above 38.1°C

Common (may affect up to 1 in 10 people):

Redness at the injection site

Uncommon (may affect up to 1 in 100 people):

Hardening at the injection site

Reactions occurring with unknown frequency (frequency cannot be estimated because these reactions are reported very rarely):

Restlessness, drowsiness, and irritability within the first hours or days after vaccination, rapidly resolving
Seizures (febrile or non-febrile) within a few days after vaccination, headache, mild and transient tingling sensation (paresthesia), usually in the lower limbs, within two weeks after vaccination
Extensive skin changes (rash)
Mild and transient joint pain and muscle pain within a few days after vaccination
Reactions at the injection site: enlargement of lymph nodes, swelling (edema), which may occur within 48 hours after vaccination and may last for 1 to 2 days.

Additional information regarding specific populations:
In prematurely born infants (born at 28 weeks of gestation or earlier), prolonged breathing pauses may occur within 2–3 days after vaccination.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further information on the vaccine's safety.

5. How to store the IMOVAX POLIO vaccine

Keep the vaccine out of sight and reach of children.
Do not use this vaccine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C).
Keep in the original packaging to protect from light. Do not freeze.
Do not use this vaccine if it becomes cloudy.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What IMOVAX POLIO vaccine contains
The active substances in one dose (0.5 ml) are:
Poliovirus (inactivated)
Type 1 (Mahoney strain) …. 29 D antigen units*
Type 2 (MEF-1 strain) ......... 7 D antigen units*
Type 3 (Saukett strain) ......... 26 D antigen units*
The vaccine complies with the requirements of the European Pharmacopoeia and WHO recommendations.
It is propagated on VERO cells.
* These antigen amounts are exactly the same as previously expressed as 40-8-32 D antigen units, respectively for virus types 1, 2 and 3, measured by another appropriate immunochemical method.

Other ingredients are:
phenoxyethanol, formaldehyde, Hanks' 199 medium containing (in particular) amino acids, mineral salts, vitamins and water for injections, and hydrochloric acid or sodium hydroxide to adjust pH.

What IMOVAX POLIO vaccine looks like and contents of the pack
IMOVAX POLIO is a clear, colourless suspension for injection supplied in a pre-filled syringe.

1 pre-filled syringe with needle, 0.5 ml
20 pre-filled syringes with needles, 0.5 ml
1 pre-filled syringe, 0.5 ml + 1 needle supplied separately in the package
1 pre-filled syringe, 0.5 ml + 2 needles supplied separately in the package
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France

Manufacturers:
Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
Sanofi-Aventis Zrt.
Building DC5
Campona utca 1.
1225 Budapest, Hungary

Information intended exclusively for healthcare professionals:
Method of administration
For syringes not supplied with attached needles, a separate needle must be firmly attached to the syringe by turning it a quarter turn.
Ensure that the vaccine is clear and colourless. Do not use this vaccine if it is cloudy.
Intramuscular (im.) administration is recommended; however, the vaccine may also be administered subcutaneously (sc.).
Do not administer intravenously. Before administration, ensure that the needle is not located within a blood vessel.