IMOVAX 0.5 ML Injectable suspension

Зміст інструкції

1. IMOVAX TETANO
   1. WHAT IS IMOVAX TETANO AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU AND/OR YOUR CHILD ARE GIVEN
   3. HOW IMOVAX TETANUS WILL BE ADMINISTERED TO YOU AND/OR THE CHILD
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE IMOVAX TETANO
   6. PACKAGE CONTENTS AND OTHER INFORMATION

IMOVAX TETANO

Injectable suspension in pre-filled syringe
Adsorbed tetanus vaccine

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 TETANO is and what it is used for
• 2. What you need to know before IMOVAX TETANO is given to you and/or your child
• 3. How IMOVAX TETANO will be given to you and/or your child
• 4. Possible side effects
• 5. How to store IMOVAX TETANO
• 6. Contents of the pack and other information

1. WHAT IS IMOVAX TETANO AND WHAT IS IT USED FOR

IMOVAX TETANO (TT) 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 TETANO is a vaccine that helps to protect adults and children over 3 months of age
against tetanus.
In particular, it is used in the following cases:

• primary vaccination (vaccination for primaryprevention against tetanus)
• booster (to strengthen protection against tetanus)

This vaccine works by stimulating the body to produce a protection (antibodies) against the bacteria that
cause tetanus infection.

What is tetanus?
Tetanus (often described as “lockjaw”) is a non-contagious infectious disease caused by tetanus bacteria that penetrate a deep wound in the skin. The bacteria
release a toxin (poison) that causes muscle spasms, leading to difficulty breathing and
risk of suffocation.

2. WHAT YOU NEED TO KNOW BEFORE YOU AND/OR YOUR CHILD ARE GIVEN

IMOVAX TETANO
The following situations must still be evaluated by the doctor, who will take into account the possibility of postponing the tetanus vaccination.

Do not take IMOVAX TETANO

• if you and/or your child are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6)
• if you and/or your child have previously had an allergic reaction or brain disorders following a previous vaccination
• if you and/or your child have a fever or current illnesses
• if you and/or your child are taking immunosuppressant medicines (medicines that reduce the activity of the immune system, for example after an organ transplant), as the immune response to the vaccine may not be adequate. However, at the doctor's discretion, if vaccination is given during treatment with immunosuppressants, the doctor may administer a supplemental dose of IMOVAX TETANO a few weeks after the end of treatment.

Warnings and precautions
Talk to your doctor or pharmacist before you and/or your child are given IMOVAX
TETANO.
In particular, tell your doctor before vaccination if you and/or your child:

• have had a temporary loss of motor skills and sensation (Guillain-Barré syndrome) or loss of motor skills, pain and numbness in the arm and shoulder (brachial neuritis), following a previous injection of a vaccine containing the tetanus component.

The decision to administer any vaccine against tetanus must be carefully evaluated by the
doctor in consideration of the potential benefits and possible risks to you and/or your child, and in
consideration of whether or not the primary immunization schedule has been completed.
Fainting may occur following, or even before, any injection with a needle. Therefore, tell the
doctor or nurse if you or your child have fainted after a previous injection.

Children and adolescents
This vaccine can be used in children over 3 months of age for primary immunization.
In children, vaccination is generally justified when they have not completed the primary immunization cycle (i.e., those who have received less than three doses).
When the primary immunization series is performed in very premature infants (born at 28
weeks of gestation or earlier), the potential risk of apnea and the need to monitor breathing for the 48-72 hours following vaccination should be considered, particularly for
children with a previous history of respiratory failure.
Because the benefit of vaccination in this group of children is high, vaccination should not
be suspended or delayed.

Other medicines and IMOVAX TETANO
Tell your doctor or pharmacist if you and/or your child are taking, have recently taken or
may take any other medicines.
IMOVAX TETANO can be administered together with tetanus antitetanus immunoglobulins, provided they are
injected with a different syringe and at a different site on the body.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your
doctor for advice before using this medicine. The doctor will determine whether you should receive
IMOVAX TETANO.

Driving and operating machinery
IMOVAX TETANO has no or negligible effect on the ability to drive and operate machinery.

IMOVAX TETANO contains potassium and sodium
IMOVAX TETANO contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, which is
equivalent to saying it is essentially "potassium-free" and "sodium-free".

3. HOW IMOVAX TETANUS WILL BE ADMINISTERED TO YOU AND/OR THE CHILD

Adults and children over 3 months of age
This medicine will be prepared and administered to you and/or the child only by healthcare personnel
trained in the use of vaccines and who is equipped to intervene in the event of any serious, uncommon allergic reaction following the injection.
The recommended dose is one injection of 0.5 ml, at any age.
This medicine will be administered to you and/or the child through an injection into a muscle or
under the skin.

Primary vaccination(vaccination for primaryprevention against tetanus)
Primary vaccination consists of 3 doses of vaccine administered according to the following schedule:

Newborns:
1st dose: at three months
2nd dose: 6-8 weeks after the first dose
3rd dose: 6-12 months after the second dose

Adults:
1st dose: on the established date
2nd dose: 6-8 weeks after the first dose
3rd dose: 6-12 months after the second dose

Booster(to strengthen protection against tetanus)
The first booster administration is given after 4-5 years, subsequent boosters after 10 years.

Treatment of trauma patients(treatment following wounds or traumas at risk of tetanus)
The type of treatment to be carried out must be evaluated by the emergency room doctor based on the
characteristics of the wound and the agent that caused the trauma. The doctor will adopt the appropriate
vaccination schedule based on your and/or the child's age, the vaccinations you have already received, or if
you have not been vaccinated.
Children up to 6 years of age

• 1) If the subject has been vaccinated regularly with three inoculations of anatoxin as provided by current regulations, a booster inoculation can be given if more than 5 years have passed since the last anatoxin inoculation, thus completing the vaccination cycle.
• 2) If the subject has not been vaccinated, human immunoglobulins can be given based on body weight (7IU/kg up to a maximum of 250IU) and one inoculation, in another site, of a dose of tetanus vaccine after 6-8 weeks, continuing the vaccination according to the primary vaccination schedule.
• 3) If the subject has received only 1 or 2 inoculations of anatoxin, human immunoglobulins can be given and the vaccination cycle can then be completed when the time elapsed since the first inoculation or the first two inoculations is not more than, respectively, one year and 5 years; when the time elapsed since the first inoculation or the first two inoculations exceeds the above intervals, the vaccination cycle is repeated from the beginning.

Subjects over 6 years of age

• 1) If the subject over 6 years of age has been vaccinated regularly (primary vaccination and first booster inoculation): a) from the 1st to the 5th year after the last inoculation, no booster or immunoglobulin administration is necessary; b) from the 6th to the 10th year after the last inoculation: administer a booster dose; c) beyond the 10th year after the last inoculation: administer human antitetanus immunoglobulins and a booster dose.
• 2) If the subject has not been vaccinated: inoculation of human antitetanus immunoglobulins (250IU) simultaneously with the start of vaccination.
• 3) If the subject has not completed the series of 4 inoculations: follow the instructions for children up to 6 years of age.

Use in children
Vaccination is generally justified for children who have not completed the primary immunization cycle (i.e. those who have received less than three doses).
In case of accidental ingestion/intake of an excessive dose of IMOVAX TETANUS, immediately inform
the doctor or go to the nearest hospital.
If you have any further questions about the use of this product, ask your doctor, healthcare professional or
pharmacist.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with all vaccines, allergic reactions may occur, which, in rare cases, can lead to
shock (severe allergic reaction).
All of the following reactions have been more frequently observed in hyperimmunized subjects, in
particular in the case of too frequent booster shots.
If you and/or the child experience the following serious allergic reactionsafter leaving the place where the
vaccine was administered, consult a doctor IMMEDIATELY:

• difficulty breathing
• bluish discoloration of the tongue or lips
• low blood pressure (causing dizziness)
• collapse.

However, these allergic reactions usually develop immediately after the injection is administered
and while you and/or the child are still in the hospital or doctor's office.
In addition, the following side effects may occur, the frequency of which is unknown:

Hematolymphopoietic System Disorders

• lymphadenopathy (enlargement of the lymph nodes, structures found mainly in the neck, chest and groin)

Immune System Disorders

• Type I hypersensitivity reactions

Nervous System Disorders

• headache
• dizziness

Vascular Disorders

• Hypotension (in the context of Type I hypersensitivity reactions)

Skin and Subcutaneous Tissue Disorders

• allergy-like symptoms, such as generalized itching, urticaria (skin redness accompanied by itching) or erythema (skin irritation) Musculoskeletal and Connective Tissue Disorders
• myalgia (muscle pain)
• arthralgia (joint pain)

Systemic Disorders and Conditions Related to the Site of Administration

• local reactions at the injection site such as:
• pain, rash, hardening or edema (swelling), which may occur within 48 hours and persist for one or two days. These reactions can sometimes be associated with the formation of a subcutaneous nodule (formation of a nodule under the skin)
• aseptic abscesses (infection characterized by pus collection that can develop anywhere in the body).

The frequency and severity of local reactions may be influenced by the site, the method of
administration and the number of previous vaccine doses received:

• transient pyrexia (transient fever)
• malaise.

Other side effects that have been reported with other tetanus vaccines such as IMOVAX TETANO,
and which may therefore be potential side effects of IMOVAX TETANO as well, are:

• temporary loss of motility or sensation (Guillain-Barré syndrome)
• loss of motility, pain and numbness (brachial neuritis) of the arm and shoulder.

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 for 2-3
days after vaccination.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly via the website
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 TETANO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Scad”. 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 TETANO contains

• The active ingredient is: purified tetanus anatoxin (1) 40 IU per 0.5 ml dose
• (1) adsorbed on hydrated aluminum hydroxide ………………………0.6 mg Al
• The other ingredients are: Acetic acid (pH regulator), sodium hydroxide (pH regulator) and a buffer solution containing sodium chloride, disodium phosphate dihydrate, dipotassium phosphate, hydrochloric acid (pH regulator), sodium hydroxide (pH regulator) and water for injections.

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

Manufacturers:
Sanofi Pasteur
1541 Avenue Marcel Merieux
69280 Marcy L’Etoile (France)

or, alternatively
Sanofi Pasteur
Parc Industriel d’Incarville
27100 Val de Reuil (France)
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The following information is intended exclusively for doctors or healthcare professionals:
As with all injectable vaccines, adequate treatment and
medical supervision must always be readily available in case of a rare anaphylactic reaction following vaccine administration.
In the absence of compatibility studies, this medicine should not be mixed with other medicines.
The vaccine must be used as provided; no reconstitution is necessary.
Shake well before use. Thorough shaking is necessary to maintain the vaccine in
suspension.
The vaccine must be administered by intramuscular or subcutaneous route.
IMOVAX TETANO is an adsorbed vaccine and therefore the intramuscular route is preferable to minimize local reactions. The recommended injection sites are the upper anterolateral area of the thigh in children and infants and the deltoid muscle in adults.
The vaccine can also be administered by deep subcutaneous injection.
The intradermal route of administration should not be used.
Do not administer intravenously: therefore, before injecting the product, ensure that the needle of the
syringe has not penetrated a blood vessel.
It is important to use sterile syringes and needles different for each patient to avoid the transmission of
infectious agents from one individual to another.
Unused medicine or waste material derived from such medicine must be disposed of in accordance with
current local regulations.
See also section 3. HOW TO USE IMOVAX TETANO.