Imovax Polio

Package Leaflet: Information for the User

IMOVAX POLIO,suspension for injection in a pre-filled syringe
Polio vaccine (inactivated)
Read carefully the package leaflet before using the vaccine, as it contains important information for the patient.

• Keep this leaflet until you have completed the entire vaccination cycle, so that you can read it again if necessary.
• If you have any further questions, ask your doctor, nurse, or pharmacist.
• This vaccine has been prescribed specifically for you. Do not pass it on to others.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. See section 4.

Table of contents of the leaflet:

• 1. What is IMOVAX POLIO and what is it used for
• 2. Important information before using IMOVAX POLIO
• 3. How to use IMOVAX POLIO
• 4. Possible side effects
• 5. How to store IMOVAX POLIO
• 6. Contents of the pack and other information

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

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

2. Important information before using IMOVAX POLIO

When not to use IMOVAX POLIO:

• if you are allergic (hypersensitive) to any of the active substances or other components (listed in section 6), to neomycin, streptomycin, or polymyxin B,
• if you have had an allergic reaction after previous administration of IMOVAX POLIO or a vaccine containing the same substances,
• if you have a fever or sudden illness (acute disease), vaccination should be postponed.

Warnings and precautions

Special caution should be exercised when using IMOVAX POLIO if:

• you have bleeding disorders such as low platelet count (thrombocytopenia) or coagulation disorders, as there is a risk of bleeding during intramuscular administration,
• you are receiving treatment that lowers your immune system (corticosteroids, cytotoxic drugs, radiotherapy, or any other treatment that may weaken your immune system) or you have an immune system disorder (immunosuppression), in which case the immune response to the vaccine may be reduced. In such cases, it is recommended to postpone vaccination until the treatment is completed or to ensure that the patient is properly protected,
• you have a chronic immune system disorder, such as HIV infection (AIDS), in which case vaccination is recommended even if the immune response may be limited.

This vaccine may also be indicated as a booster dose in individuals previously vaccinated with oral poliovirus vaccine.
Fainting can occur after, or even before, any needle injection. Therefore, you should inform your doctor or nurse if you have fainted after previous injections.
If you have any doubts, you should consult your doctor or pharmacist.

IMOVAX POLIO and other medicines

There is no known risk associated with the administration of IMOVAX POLIO at the same time as other standard vaccines.
You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

The vaccine can be used during pregnancy if there is a high risk of infection.
Breastfeeding is not a contraindication.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before using this vaccine.

Driving and using machines

It is unlikely that the vaccine will affect your ability to drive or use machines. However, no studies have been conducted in this regard.

IMOVAX POLIO contains phenylalanine, ethanol, and sodium

IMOVAX POLIO contains 12.5 micrograms of phenylalanine per 0.5 ml dose.
Phenylalanine may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body because the body does not eliminate it properly.
IMOVAX POLIO contains 2 mg of alcohol (ethanol) per 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 have noticeable effects.
IMOVAX POLIO contains less than 1 mmol of sodium per dose, which means that the vaccine is considered "sodium-free".

3. How to use IMOVAX POLIO

Dosage: Children

The dosing schedule should be in accordance with the national recommendations in force (National Immunization Program).
After 6 weeks of age or after 2 months of age: 3 consecutive doses of 0.5 ml of IMOVAX POLIO vaccine should be administered at an interval of one or two months, followed by the 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 national recommendations.

Administration

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

Missed administration of IMOVAX POLIO:

Your doctor will decide when to administer the missed dose.
If you have any further doubts about the use of this vaccine, you should consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

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 following symptoms occur after leaving the vaccination site, you should contact your doctor or emergency services immediately:

• Skin changes with itching (hives)
• Sudden swelling of the face and neck and difficulty breathing (angioedema, Quincke's edema)
• Sudden and severe malaise with low blood pressure causing dizziness and loss of consciousness, rapid heart rate associated with respiratory disorders (anaphylactic reaction and shock).

Other side effects:

If you experience any of the following side effects, or if they get worse, you should consult your 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 with unknown frequency (frequency cannot be estimated, as these reactions are reported very rarely):
• Restlessness, drowsiness, and irritability in the first hours or days after vaccination and resolving quickly
• Seizures (not related to or related to fever) within a few days after vaccination, headache, mild and transient tingling sensation (paresthesia), mostly in the lower limbs, within two weeks after vaccination
• Widespread skin changes (rash)
• Mild and transient joint pain and muscle pain within a few days after vaccination
• Reactions at the injection site: swelling (edema), which may occur within 48 hours after vaccination and may last for 1 to 2 days.

Additional information on special populations:

In premature infants (born before 28 weeks of gestation), within 2-3 days after vaccination, longer pauses between breaths may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this vaccine.

5. How to store IMOVAX POLIO

Store 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 month.
Store in a refrigerator (2°C - 8°C).
Store in the original packaging to protect from light. Do not freeze.
Do not use this vaccine if it is cloudy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What IMOVAX POLIO contains

The active substances of the vaccine in one dose (0.5 ml) are:

Inactivated poliovirus
Type 1 (Mahoney strain) … 29 antigen units D*
Type 2 (MEF-1 strain) … 7 antigen units D*
Type 3 (Saukett strain) … 26 antigen units D*
The vaccine complies with the requirements of the European Pharmacopoeia and WHO recommendations
grown in VERO cells
* these antigen amounts are exactly the same as previously expressed as 40-8-32 antigen units D, respectively for the virus type 1, 2, and 3, measured by another suitable immunochemical method

Other ingredients are:

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

What IMOVAX POLIO looks like and contents of the pack

IMOVAX POLIO is a clear and colorless suspension for injection in a pre-filled syringe.
1 pre-filled syringe with needle, 0.5 ml
20 pre-filled syringes with needle, 0.5 ml
1 pre-filled syringe, 0.5 ml + 1 needle attached to the packaging
1 pre-filled syringe, 0.5 ml + 2 needles attached to the packaging
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer

Marketing authorization holder:

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France

Manufacturer

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
Date of last revision of the leaflet: December 2024
Information intended for healthcare professionals only:

Administration

Regarding syringes without attached needles, a separate needle must be firmly attached to the syringe by rotating it a quarter turn.
Make sure the vaccine is clear and colorless. Do not use this vaccine if it is cloudy.
Intramuscular administration (im) is recommended; however, the vaccine can also be administered subcutaneously (sc).
Do not administer intravascularly. Before administration, make sure the needle is not in a blood vessel.