IMOVAX POLIO Injectable Suspension in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

IMOVAX POLIO injectable suspension in pre-filled syringe

Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you or your child.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed to you or your child, and you should not give it to others.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Imovax Polio and what is it used for
2. What you need to know before you or your child receive Imovax Polio
3. How to use Imovax Polio
4. Possible side effects
5. Storage of Imovax Polio
6. Package contents and further 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. This vaccine helps protect against polio. When an injection of Imovax Polio is given, the body's natural defenses produce protection against poliovirus infection (polio). Imovax Polio can be given to infants from 2 months of age, children, and adults.

Polio is an infectious disease that is usually spread through the ingestion of poliovirus present in food or drink. It can also be contracted by eating with unwashed hands if there are viruses on them. 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, but they can cause the body to produce antibodies to protect against future infections.

2. What you need to know before you or your child are given Imovax Polio

Do not useImovax Polio

• if you or your child are allergic (hypersensitive) to the active substance, 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 any acute illness, including febrile illness with high fever, at the time of vaccination. Vaccination with Imovax Polio may need to be delayed until after recovery from the infection. A mild illness without fever, such as a mild upper respiratory tract infection, is usually 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 inactivated poliovirus vaccine along with other active components. Your doctor or nurse will advise whether Imovax Polio can still be given.

• if you or your child have immune system problems for any reason (including HIV infection), so that your immune system is weakened. Nevertheless, Imovax Polio can be given to you or your child, but 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 a blood test be done some time after vaccination to check if a good response occurred or not.
• if you or your child have any bleeding problems that cause bruising or prolonged bleeding after small cuts. Your doctor or nurse may advise that Imovax Polio be given to you or your child, but extra precautions are needed due to the risk of bleeding at the injection site. Occasionally, to reduce the risk of bleeding, your doctor or nurse may give Imovax Polio as a deep injection into the skin instead of into the muscle (see section 3).

Fainting can occur after any injection with a needle, or even before. Therefore, inform your doctor or nurse if you or your child have fainted with any previous injection.

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

Other medicines or vaccines and Imovax Polio

Imovax Polio can usually be given at the same time as other vaccines. If this is necessary, the different vaccines will be given separately at different injection sites.

In the case of medical treatment that affects the body's natural defenses, see the previous section "Warnings and precautions".

Tell your doctor or nurse if you or your child are taking, have recently taken, or might take any other medicines.

Pregnancy, breast-feeding, and fertility

If you or your daughter are pregnant or breast-feeding, think you or your daughter might be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.

Imovax Polio should only be given to pregnant women if clearly necessary. Your doctor or nurse will advise whether vaccination should be delayed or not.

The effect of vaccination during breast-feeding has not been evaluated.

Driving and using machines

Some of the possible side effects mentioned in section 4 of this leaflet (such as dizziness) may affect your ability to drive or use machines.

Imovax Polio contains phenylalanine, ethanol, and sodium

Imovax Polio contains 12.5 micrograms of phenylalanine per 0.5 ml dose. Phenylalanine may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

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

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

3. How to use Imovax Polio

Vaccination should be given by medical or healthcare professionals who are trained in the use of vaccines and are equipped to deal with any rare, severe allergic reaction to the injection.

Imovax Polio is usually given by injection into a muscle in the upper arm or, in infants and very young children, into the upper leg. For people with a high risk of bleeding after a deep injection into the muscle, the vaccine can be injected under the skin. Your doctor or nurse will avoid giving the injection into a blood vessel.

First vaccination cycle

You or your child will need three injections of 0.5 milliliters of Imovax Polio if you or your child have never been vaccinated against polio before. The vaccine can be given 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 tell you when the second and third doses will be given.

Booster vaccination

Booster doses of Imovax Polio are needed to ensure that protection continues. Your doctor or nurse will advise when booster doses should be given. Imovax Polio can be given to you or your child as a booster dose if you or your child previously received doses of oral poliovirus vaccine.

4. Possible side effects

Like all medicines and vaccines, Imovax Polio can cause side effects, although not everybody gets them.

Severe allergic reactionsare a very rare possibility after receiving any vaccine. These reactions occur in less than one in 10,000 people. Symptoms can 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 occur, 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 given, you should consult a doctor IMMEDIATELY.

Other side effects

• Very common side effects (may affect more than 1 in 10 people):

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

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

• Redness at the injection site.
• Dizziness.
• Nausea, vomiting, diarrhea.
• Joint and muscle pain.
• Headache, drowsiness.
• Irritability and crying.
• Difficulty sleeping.
• Dizziness.

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

• Swelling at the injection site.

• Side effects reported during commercial use (frequency cannot be estimated from available data):

• Swollen glands.

• Swelling or rash at the injection site that lasts 1-2 days.
• Rashes on other parts of the body that may be raised and itchy.
• Flu-like symptoms, usually only on the day of vaccination.
• Seizures with or without fever.
• Apnea within 2 weeks after vaccination that will disappear without treatment.
• Restlessness or drowsiness

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

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Imovax Polio

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the packaging and label after CAD/EXP. The expiry date is the last day of the month stated.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Imovax Polio

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

Inactivated poliovirus type 1 (Mahoney)1 29 units of antigen D2

Inactivated poliovirus type 2 (MEF-1)1 7 units of antigen D2

Inactivated poliovirus type 3 (Saukett)1 26 units of antigen D2

1 Cultivated in Vero cells

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

The other ingredients are:

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

Appearance of the product and package contents

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 packs of 1, 10, or 20 pre-filled syringes (doses). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

The manufacturer 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 under the following names:

Date of last revision of this leaflet:July 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

The vaccine should 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