IMOVAX Injectable suspension

Зміст інструкції

1. IMOVAX POLIO
   1. What is IMOVAX POLIO and what is it used for
   2. What you need to know before you and/or your child are given IMOVAX POLIO
   3. How IMOVAX POLIO will be administered to you and/or the child
   4. Possible side effects
   5. How to store IMOVAX POLIO
   6. Package contents and other information

IMOVAX POLIO

Injectable suspension in pre-filled syringe
Poliomyelitis vaccine (inactivated)

Read this leaflet carefully before you and/or your child are given this
medicine as it contains important information for you and/or your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you and/or your child. Do not give it to other people, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What IMOVAX POLIO is and what it is used for
• 2. What you need to know before IMOVAX POLIO is given to you and/or your child
• 3. How IMOVAX POLIO will be given to you and/or your child
• 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 you and/or the child against infectious diseases. They work by
stimulating the body to produce its own protection against the disease for which the vaccine is
specific.
IMOVAX POLIO is a vaccine that helps protect adults and children over 2 months of ageagainst
Poliomyelitis, and is used in the following cases:

• primary vaccination (vaccination for primary prevention against poliomyelitis);
• booster (to strengthen protection against poliomyelitis). You and/or the child can also have a booster vaccination even if you have been previously vaccinated with the oral polio vaccine. IMOVAX POLIO can also be used if you and/or the child cannot receive the oral polio vaccine and/or have problems with the immune system (for example in case of HIV infection).

What is poliomyelitis?
Poliomyelitis is a viral infection. Poliomyelitis often manifests only with mild discomfort.
However, sometimes it can be very serious and cause permanent damage or even death. Poliomyelitis can cause muscle immobility (muscle paralysis) including the muscles responsible for
breathing and movement. The arms or legs affected by this disease can be painfully
deformed.

2. What you need to know before you and/or your child are given IMOVAX POLIO

Do not use/do not give to the child IMOVAX POLIOif you and/or the child

• are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• have had an allergic reaction following a previous vaccination with IMOVAX POLIO or with another vaccine containing the same components;
• have a fever or ongoing illnesses.

Warnings and precautions
Consult your doctor or pharmacist before you and/or your child are given IMOVAX POLIO.
In particular, tell your doctor beforevaccination if you and/or the child:
suffer from thrombocytopenia (reduced number of platelets in the blood), as you and/or the child
may experience bleeding after vaccination;
suffer from blood coagulation disorders, as you and/or the child may experience
bleeding after vaccination;
have already undergone other vaccinations in the past;
have suffered in the past from allergic reactions following previous vaccinations;
have recently suffered from an illness. It is important to inform the doctor about the current health
status of you and/or the child;
are allergic to neomycin, streptomycin and polymyxin B (antibiotics). Because IMOVAX POLIO
may contain traces of these substances, healthcare professionals will take appropriate precautions if
you and/or the child are allergic to these substances;
are receiving immunosuppressive treatment (treatment that reduces the activity of the immune
system, for example after an organ transplant) or have problems with the immune system (the
system that protects the body from infections). The doctor may decide to postpone vaccination
until the end of treatment or illness. However, if you and/or the child have chronic problems with the
immune system (for example in case of HIV infection) vaccination with IMOVAX POLIO
can be performed.
The decision to administer any vaccine must be carefully evaluated by the doctor in
consideration of the potential benefits and possible risks for you and/or the child.
Fainting may occur following, or even before, any injection with a needle. Therefore, inform
your doctor or nurse if you or your child have fainted after a previous injection.

Children and adolescents
This vaccine can be used for primary vaccination in children from two months of age, and
for booster vaccinations in children from 5-6 years of age.
In case of primary vaccination in newborns, inform the doctor if the newborn was born very prematurely (at 28
weeks of gestation or earlier), and especially if they have had respiratory problems. In this case the doctor
will monitor the newborn's breathing for the 48-72 hours following vaccination, due to a
potential risk of apnea (longer than normal intervals between breaths). Because the benefit
of vaccination in this group of newborns is high, the doctor will never consider the
possibility of suspending or postponing vaccination (see section 4 “Additional undesirable effects
in children”).

Other medicines and IMOVAX POLIO
Tell your doctor or pharmacist if you and/or the child are taking, have recently taken or
may take any other medicines.
IMOVAX POLIO can be given to you and/or the child in the same vaccination session together with the most
common vaccines for children and adults. If administered simultaneously with other vaccines, the
healthcare professionals will use different syringes and separate injection sites.
In particular, tell your doctor if you and/or the child are receiving immunosuppressive treatment
(treatment that reduces the activity of the immune system), for example:

• hormones (long-term therapy)
• chemotherapy
• radiotherapy, as the response to the vaccine may be reduced. In this case, the doctor may decide to postpone vaccination until the end of treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
IMOVAX POLIO will notbe given to you if you are pregnant, unless your doctor considers it absolutely necessary.

Breastfeeding
IMOVAX POLIO will notbe given to you if you are breastfeeding, unless your doctor considers it
absolutely necessary.

Fertility
Generally, if you are of childbearing potential and are not using contraception, IMOVAX POLIO will not be
given to you.

Driving and operating machinery
No studies have been conducted on the ability to drive vehicles and operate machinery.

IMOVAX POLIO contains phenylalanine, ethanol and sodium
IMOVAX POLIO contains 12.5 micrograms of phenylalanine in each 0.5 ml dose. Phenylalanine
may be harmful if you suffer from phenylketonuria (PKU), a rare genetic disease in which phenylalanine
accumulates because the body cannot dispose of it properly.
IMOVAX POLIO contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The amount in a dose of
this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this
medicine will not have noticeable effects.
IMOVAX POLIO contains less than 1 mmol of sodium per dose, that is to say essentially "sodium-free" .

3. How IMOVAX POLIO will be administered to you and/or the child

This medicine will be prepared and administered to you and/or the child only by healthcare professionals.
This medicine will be administered to you and/or the child through an injection into a muscle or
under the skin.

Adults and children over 2 months of age
➢ Primary vaccination(vaccination for primaryprevention against poliomyelitis)

Children from two months of age:3 injections of 0.5 ml at 6-8 week intervals from each other.

Adults:2 injections of 0.5 ml at 1 or 2 months intervals from each other.
➢ Booster(to strengthen protection against poliomyelitis)

Children aged 5-6 years: 1 injection of 0.5 ml

Adults: one injection of 0.5 ml 6-12 months after the second injection of the primary vaccination.

Adults who have been immunized
➢ In case of increased risk of exposure to poliomyelitis
1 injection of 0.5 ml.

If you and/or the child take more IMOVAX POLIO than you should
Since this medicine is prepared and administered by healthcare professionals, it is unlikely that you and/or the
child will receive an excessive dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you and/or the child experience the following side effects immediately after administration of the vaccine
or after leaving the place where the vaccine was administered, consult a doctor IMMEDIATELY:

Systemic diseases and conditions related to the injection site

Very common (may affect up to 1 in 10 people)
pain at the injection site
fever

Common (may affect up to 1 in 100 people)
redness at the injection site
swelling at the injection site
Pain, redness and swelling at the injection site are side effects that may occur within 48 hours
following vaccination and persist for at least one or two days.
In addition, the following side effects may occur with unknown frequency:

Not known (cannot be estimated from available data)
Blood and lymphatic system disorders

• lymphadenopathy (enlargement of the lymph nodes, structures located mainly in the neck, chest and groin) Systemic diseases and conditions related to the injection site
• allergic reactions, including severe ones (anaphylactic reactions or anaphylactic shock) Musculoskeletal and connective tissue disorders
• mild and transient arthralgia (joint pain)
• myalgia (muscle pain) Nervous system disorders
• convulsions (with or without fever)
• headache
• mild and transient paresthesia (tingling), mainly localized to arms and legs Psychiatric disorders
• agitation
• drowsiness
• irritability

Skin and subcutaneous tissue disorders

• skin rashes (rash)
• urticaria (skin redness accompanied by itching).

Additional side effects in children
In very premature infants (at the 28th week of gestation or earlier), longer than normal intervals between breaths (apnea) may be observed, 2-3 days
after vaccination.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist, or nurse. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store IMOVAX POLIO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “EXP”.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IMOVAX POLIO contains

• the active substances are: inactivated poliovirus type 1* Antigen D: 29 units** inactivated poliovirus type 2* Antigen D: 7 units** inactivated poliovirus type 3* Antigen D: 26 units**

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

• other components are: 2-phenoxyethanol, formaldehyde, medium 199, hydrochloric acid or sodium hydroxide for pH adjustment. (contains sodiumand potassium. See section "IMOVAX POLIO contains sodium and potassium”).

Description of the appearance of IMOVAX POLIO and contents of the pack
IMOVAX POLIO is an injectable suspension in a pre-filled syringe of 0.5 ml with a pre-attached needle and
needle cap. The packs contain 1 pre-filled syringe.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Representative for Italy
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milano
Manufacturer:
Sanofi Pasteur
Campus Merieux
1541 Avenue Marcel Merieux
69280 Marcy l’Etoile (France)
Sanofi Pasteur
Parc industriel d’Incarville
27100 Val de Reuil (France)
Sanofi-Aventis Zrt.
Building DC5
Campona utca 1.
Budapest, 1225
Hungary

This leaflet was last updated on
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The following information is intended exclusively for doctors or healthcare professionals

Precautions for use
Do not administer under any circumstances intravascularly: ensure that the needle does not penetrate a
blood vessel;
Before administering any biological product, the person responsible for
administration must take all necessary precautions to prevent allergic or
any other type of reaction. As with all injectable vaccines, appropriate treatments and medical supervision
must always be readily available in case of rare anaphylactic reactions following
vaccine administration.

Method of administration
The vaccine must be administered by a doctor or healthcare professional who has been trained in the use
of vaccines and who is equipped to intervene in the event of any serious
uncommon allergic-type reaction occurring after the injection.
The vaccine is administered by subcutaneous or intramuscular route.
Recommended injection sites are the anterolateral thigh area in infants and the deltoid muscle
in children, adolescents and adults.
Do not administer intravascularly: ensure that the needle does not penetrate a blood vessel.
For primary immunization and booster doses, IMOVAX POLIO can be administered in accordance with
current local recommendations (National Vaccination Prevention Plan 2012-2014 Official Gazette No. 60 of 12/3/2012)
or international recommendations regarding traveler prophylaxis.
See also section 3. How IMOVAX POLIO will be administered to you and/or the child.