Imovax tetanus

Italy
Brand name Imovax tetanus
Form suspension, for injection
Active substance / Dosage
TETANUS VACCINE ADSORBED
Prescription type Prescription only
ATC code
J07AM01
Registration number 026171
Manufacturer SANOFI WINTHROP INDUSTRIE

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

IMOVAX TETANUS

Injectable suspension in pre-filled syringe
Adsorbed tetanus vaccine
Please read all of this leaflet carefully before this medicine is administered to you and/or your child, because 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 for you and/or your child only. Do not give it to others, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

IMOVAX TETANUS (TT) is a vaccine.
Vaccines are used to protect you and/or your 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 TETANUS is a vaccine that helps protect adults and children over 3 months of age
against tetanus.
It is specifically used in the following cases:

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

This vaccine works by stimulating the body to produce protection (antibodies) against the bacteria that
cause tetanus infection.
What is tetanus?
Tetanus (often described as "lockjaw") is an infectious, non-contagious disease caused by tetanus bacteria entering a deep skin wound. The bacteria
release a toxin (poison) that causes muscle spasms, leading to breathing difficulties and risk of suffocation.

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

IMOVAX TETANUS
The following situations should always be evaluated by the doctor, who will consider whether tetanus vaccination cannot be postponed.
Do not take IMOVAX TETANUS

  • if you and/or your child are allergic to the active substance or to 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 ongoing illnesses
  • if you and/or your child are taking immunosuppressive 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, according to the doctor's judgment, if vaccination occurs during treatment with immunosuppressants, the doctor may administer an additional dose of IMOVAX TETANUS 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 TETANUS.
In particular, inform your doctor before vaccination if you and/or your child:

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

The decision to administer any tetanus vaccine must be carefully evaluated by the doctor, weighing the potential benefits against possible risks for you and/or your child, and considering whether or not the primary immunization schedule has been completed.
Fainting may occur following, or even before, any injection with a needle. Therefore, inform the doctor or nurse if you or your child have previously fainted after an injection.
Children and adolescents
This vaccine can be used in children older than 3 months for primary immunization.
In children, vaccination is generally justified when they have not completed the primary immunization cycle (i.e., those who have received fewer than three doses).
When the primary immunization series is administered to very premature infants (born at 28 weeks of gestation or earlier), the potential risk of developing apnea and the need to monitor breathing for 48–72 hours after vaccination should be considered, particularly in infants with a previous history of respiratory insufficiency.
Since the benefit of vaccination in this group of children is high, vaccination should not be suspended or delayed.
Other medicines and IMOVAX TETANUS
Inform your doctor or pharmacist if you and/or your child are taking, have recently taken, or might take any other medicines.
IMOVAX TETANUS may be administered together with tetanus immunoglobulins, provided they are injected using a different syringe and at a different injection site.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine. Your doctor will decide whether you should receive IMOVAX TETANUS.
Driving and using machines
IMOVAX TETANUS does not affect or has a negligible effect on the ability to drive vehicles and use machinery.
IMOVAX TETANUS contains potassium and sodium
IMOVAX TETANUS contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, i.e., 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 medicinal product will be prepared and administered to you and/or the child only by healthcare personnel trained in vaccine use and equipped to intervene should any uncommon, severe allergic-type reaction occur after injection.
The recommended dose is one 0.5 ml injection, regardless of age.
This medicine will be administered to you and/or the child as an injection into a muscle or under the skin.

Primary vaccination (vaccination for primary prevention against tetanus)
Primary vaccination consists of 3 vaccine doses administered according to the following schedule:
Newborns:
1st dose: at 3 months of age
2nd dose: 6–8 weeks after the first dose
3rd dose: 6–12 months after the second dose
Adults:
1st dose: at the scheduled date
2nd dose: 6–8 weeks after the first dose
3rd dose: 6–12 months after the second dose

Booster dose (to reinforce protection against tetanus)
The first booster dose should be given after 4–5 years; subsequent boosters should be given every 10 years.

Management of injured patients (treatment following wounds or injuries at risk of tetanus)
The type of treatment required must be assessed by the emergency physician based on the characteristics of the wound and the agent causing the injury. The physician will adopt the appropriate vaccination schedule according to your and/or the child’s age, previous vaccinations received, or whether no vaccination has been administered.

Children up to 6 years of age

  1. If the subject has been regularly vaccinated with three doses of tetanus toxoid as required by current regulations, a booster dose may be administered if more than 5 years have passed since the last toxoid dose, thus completing the vaccination cycle.
  2. If the subject has not been vaccinated, human immunoglobulins may be administered according to body weight (7 IU/kg, up to a maximum of 250 IU), and one dose of tetanus vaccine may be administered at a different injection site. The vaccination series should then continue 6–8 weeks later, following the primary vaccination schedule.
  3. If the subject has received only 1 or 2 doses of tetanus toxoid, human immunoglobulins may be administered and the vaccination cycle may be completed subsequently, provided that the time elapsed since the first dose or the first two doses does not exceed one year or five years, respectively. If the time elapsed exceeds these intervals, the vaccination cycle must be restarted from the beginning.

Subjects over 6 years of age

  1. If the subject over 6 years of age has been regularly vaccinated (completed primary vaccination and first booster dose):
    a) from 1 to 5 years after the last dose: no booster dose or immunoglobulin administration is required;
    b) from 6 to 10 years after the last dose: administer a booster dose;
    c) more than 10 years after the last dose: administer tetanus immunoglobulins and a booster dose.
  2. If the subject has not been vaccinated: administer tetanus immunoglobulins (250 IU) simultaneously with the start of vaccination.
  3. If the subject has not completed the series of 4 doses: follow the recommendations 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 fewer than three doses).

In case of accidental ingestion/overdose of IMOVAX TETANUS, inform your doctor immediately or go to the nearest hospital.
If you have any further questions about the use of this product, consult your doctor, healthcare provider, or pharmacist.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with all vaccines, allergic reactions may occur, which in rare cases may lead to shock (severe allergic reaction).
All of the following reactions have been more frequently observed in hyperimmunized individuals, particularly in the case of too frequent booster doses.
If you and/or the child experience any of the following severe allergic reactions after 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 injection, while you and/or the child are still at the hospital or medical office.
Additionally, the following adverse reactions may occur, for which the frequency is unknown:

Hematopoietic and Lymphatic System Disorders

  • lymphadenopathy (swollen lymph nodes, structures located mainly in the neck, chest, and groin)

Immune System Disorders

  • Type I hypersensitivity reactions

Nervous System Disorders

  • headache
  • dizziness

Vascular Disorders

  • hypotension (within the context of type I hypersensitivity reactions)

Skin and Subcutaneous Tissue Disorders

  • allergy-like symptoms such as generalized itching, urticaria (red, itchy skin rashes), or erythema (skin irritation)

Musculoskeletal and Connective Tissue Disorders

  • myalgia (muscle pain)
  • arthralgia (joint pain)

General Disorders and Administration Site Conditions

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

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

  • transient pyrexia (transient fever)
  • malaise.

Other adverse reactions reported with other tetanus vaccines such as IMOVAX TETANUS, and which may therefore also be potential adverse reactions of IMOVAX TETANUS, include:

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

Additional adverse reactions in children
In very premature infants (born at 28 weeks of gestation or earlier), prolonged intervals between breaths (apnea) may occur for 2–3 days after vaccination.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IMOVAX TETANUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACKAGING CONTENT AND OTHER INFORMATION

What IMOVAX TETANUS contains

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

Description of the appearance of IMOVAX TETANUS and package contents
IMOVAX TETANUS is an injectable suspension in a pre-filled syringe with a pre-attached needle, 0.5 ml per syringe, packaged in a pack containing 1 syringe.

Marketing Authorization Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Representative in Italy:
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milan
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)

The following information is intended exclusively for physicians or healthcare professionals:
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of rare anaphylactic reactions following vaccine administration.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
The vaccine should be used as supplied; no reconstitution is required.
Shake well before use. Adequate shaking is necessary to maintain the vaccine in suspension.
The vaccine should be administered by intramuscular or subcutaneous route.
IMOVAX TETANUS is an adsorbed vaccine and therefore intramuscular administration is preferred to minimize local reactions. Recommended injection sites are the anterolateral upper thigh in children and infants, and the deltoid muscle in adults.
The vaccine may also be administered by deep subcutaneous injection.
Intradermal administration must not be used.
Do not administer intravenously: therefore, prior to injection, ensure that the syringe needle has not entered a blood vessel.
It is important to use separate sterile syringes and needles for each patient to avoid transmission of infectious agents from one individual to another.
Any unused medicine or waste material resulting from this medicine must be disposed of in accordance with local regulations.
See also section 3. HOW TO USE IMOVAX TETANUS.