Package Insert: Information for the User

IMOVAX POLIO Injectable Suspension in Pre-filled Syringe

Read this package insert carefully before you or your child are vaccinated as it contains important information for you or your child.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed only for you or your child, and it should not be given to other people.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Imovax Polio (IPV) is a vaccine. Vaccines are used to protect against infectious diseases. This vaccine helps to protect against polio. When an injection of Imovax Polio is administered, the body's natural defenses produce protection against poliomyelitis (polio) infection. Imovax Polio can be administered to infants from 2 months of age, children, and adults.

Poliomyelitis (polio) is an infectious disease that is generally transmitted by consuming food or drinks contaminated with polio viruses. It can also be contracted by eating with unwashed hands if they contain viruses. The viruses spread to the nervous system and can cause permanent paralysis. The viruses in the vaccine have been inactivated so they cannot cause polio, however they can cause the body to produce antibodies to protect against future infections.

No useImovax Polio

• If you or your child are allergic (hypersensitive) to the active ingredient, to any of the excipients, or to any residual component from the manufacturing process (streptomycin, neomycin, or polymyxin B) that may be present in trace amounts (listed in section 6)
• If you or your child have, at the time, any acute illness, including high fever. It may be necessary to delay the vaccination with Imovax Polio until after recovery from the infection. A mild illness without fever, such as a mild upper respiratory tract infection, is generally not a reason to delay vaccination.

Warnings and precautions

Before vaccination, consult your doctor, pharmacist, or nurse:

• If you or your child have ever had an allergic reaction to a vaccine that contained the inactivated poliovirus vaccine along with other active ingredients. Your doctor or nurse will advise if Imovax Polio can still be administered.

• If you or your child have any problems with the immune system for any reason (including HIV infection), so that your immune system is weakened. However, Imovax Polio can be administered to you or your child, but the protection against infections after receiving the vaccine may not be as good as in people with a normal immune system. Your doctor or nurse may recommend that blood tests be done some time after vaccination to check if a good response was produced or not.
• If you or your child have any bleeding disorder that causes easy bruising or prolonged bleeding after small cuts. Your doctor or nurse may advise that Imovax Polio be administered to you or your child, but additional precautions are necessary due to the risk of bleeding at the injection site. In some cases, to reduce the risk of bleeding, your doctor or nurse may administer Imovax Polio as a deep injection into the skin instead of into the muscle (see section 3).

After any injection with a needle, or even before, dizziness may occur. Therefore, inform your doctor or nurse if you or your child has experienced dizziness with any previous injection.

Like all vaccines, Imovax Polio may not provide complete protection against the infection it is supposed to protect against, and the protection may not be lifelong.

Other medicines or vaccines and Imovax Polio

Imovax Poliocan usually be administered at the same time as other vaccines. If this is necessary, the different vaccines will be administered separately in different injection sites.

Consult the previous section "Warnings and precautions" in case of medical treatment that affects the body's natural defenses.

Inform your doctor or nurse if you or your child is taking, has taken recently, or may need to take any other medicine.

Pregnancy,breastfeeding, and fertility

If you or your daughter is pregnant or breastfeeding, or thinks you or your daughter may be pregnant, or intends to become pregnant, consult your doctor or nurse before using this medicine.

Imovax Polioshould only be administered to pregnant women if it is clearly necessary. Your doctor or nurse may advise if the vaccination should be delayed or not.

The effect of vaccination during breastfeeding has not been evaluated.

Driving and operating machinery

Some of the possible adverse reactions mentioned in section 4 of this leaflet (such as dizziness) may affect your ability to drive or operate machinery.

Imovax Polio contains phenylalanine, ethanol, and sodium

Imovax Poliocontains 12.5 micrograms of phenylalanine in each 0.5 ml dose. Phenylalanine may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Imovax Polio contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol contained in this vaccine will have no perceptible effect.

Imovax Polio contains less than 1 mmol of sodium per dose, that is essentially "sodium-free".

Vaccination should be administered by medical professionals or healthcare workers who are trained in the use of vaccines and equipped to respond to any severe allergic reactions that are rare with injections.

Imovax Polio is generally administered by injection into a muscle in the upper arm or, in infants and very young children, in the upper thigh. For individuals with a high risk of bleeding after a deep muscle injection, the vaccine may be injected under the skin. Your doctor or nurse will avoid administering the injection into a blood vessel.

Primary Vaccination Series

You or your child will need three 0.5-milliliter injections of Imovax Polio if you have never been vaccinated against poliomyelitis (polio) before. The vaccine can be administered from 2 months of age onwards. There should be an interval of at least one month between the three doses. Your doctor or nurse will inform you when the second and third doses will be administered.

Booster Vaccination

Two booster doses of Imovax Polio are needed to ensure continued protection. Your doctor or nurse will advise you on when the booster doses should be administered. Imovax Polio can be administered to you or your child as a booster injection if you previously received doses of the polio vaccine orally.

Like all medicines and vaccines, Imovax Polio can cause side effects, although not everyone will experience them.

Severe allergic reactionsare a very rare possibility after administration of any vaccine.These reactions occur in fewer than one in 10,000 people. Symptoms may include difficulty breathing, blue discoloration of the tongue or lips, skin rash, swelling of the face or throat, and low blood pressure. When these signs or symptoms appear, they usually develop very quickly after the injection and while you or your child are still in the clinic or doctor's office. If any of these symptoms occur after leaving the place where the injection was administered, you should consult a doctor IMMEDIATELY.

Other adverse reactions

• Very common adverse reactions (may affect more than 1 in 10 people):

• Pain at the injection site.
• Fever (high temperature).

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

• Redness at the injection site.
• Dizziness.
• Nausea, vomiting, diarrhea.
• Musculoskeletal pain.
• Headache, drowsiness.
• Irritability and crying.
• Inability to sleep.
• Dizziness.

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

• Swelling at the injection site.

• Adverse reactions reported during commercial use (frequency cannot be estimated from available data):

• Swollen lymph nodes.

• Swelling or rash at the injection site lasting 1-2 days.
• Rashes on other parts of the body that may be swollen and itchy.
• Symptoms similar to the flu, usually only on the day of vaccination.
• Seizures with or without fever.
• Convulsions within 2 weeks after vaccination that will resolve without treatment.
• Restlessness or drowsiness

In very premature newborns (at 28 weeks of gestation or earlier), longer than normal pauses in breathing may occur for 2-3 days after vaccination.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the packaging and label after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C).

Do not freeze. The vaccine should not be used if it has frozen.

Store the vaccine in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines that you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need.By doing so, you will help protect the environment.

Composition ofImovax Polio

The active principles in each dose of 0.5 ml of vaccine are:

Inactivated poliovirus type 1 (Mahoney)129 unitsof antigen D2

Inactivated poliovirus type 2 (MEF-1)17 unitsof antigen D2

Inactivated poliovirus type 3 (Saukett)126 unitsof antigen D2

1Cultivated in Vero cells

2These antigen quantities are strictly the same as those previously expressed as 40-8-32 units of antigen D, for virus type 1, 2 and 3 respectively, when measured with another suitable immunochemical method.

The other components are:

2-phenoxylethanol, ethanol, formaldehyde, medium 199 without red phenol (complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components (including glucose), supplemented with polysorbate 80 and diluted in water for injectable preparations), hydrochloric acid or sodium hydroxide to adjust the pH.

Appearance of the product and contents of the package

Imovax Polio is an injectable suspension in a pre-filled syringe.

It is presented in a pre-filled syringe of 0.5 milliliters (sufficient for one dose). It is supplied in packages of 1, 10 or 20 pre-filled syringes (doses).It may only be commercially available in some package sizes.

Holder of the marketing authorization and manufacturer responsible

The holder of the marketing authorization is:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

The manufacturer responsible is:

Sanofi Winthrop Industrie

1541 avenue Marcel Mérieux

69280 Marcy l’Etoile

France

Or

Sanofi-Aventis Zrt.

Building DC5

Campona utca 1.

Budapest, 1225

Hungary

Local representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

This medicine is authorized in the member states of the European Economic Area with the following names:

Date of the last review of this leaflet:July 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

The vaccine must reach room temperature before use.

The vaccine should not be used if it is turbid, contains particles or has been frozen.

Shake before use.

See also section 3. How to use Imovax Polio