Tetravac

Package leaflet: Information for the user

Tetravac, Injectable suspension in pre-filled syringe

Adsorbed vaccine against diphtheria, tetanus, pertussis (acellular component)
and poliomyelitis (inactivated).
Please read this leaflet carefully before your child is vaccinated, as it contains
important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for your child only. Do not give it to others.
• If your child experiences any side effect, talk to your doctor, pharmacist or nurse. This also applies if any possible side effect not listed in this leaflet occurs. See section 4.

Contents of this leaflet:

1. What Tetravac is and what it is used for
2. What you need to know before Tetravac is given to your child
3. How Tetravac is given
4. Possible side effects
5. How to store Tetravac
6. Contents of the pack and other information. See section 4

1. What Tetravac is and what it is used for

Tetravac is a vaccine (DTaP-IPV vaccine) used to protect against infectious diseases.
Tetravac helps protect your child against diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis (polio).
It is administered as a primary vaccination course in children from the age of 2 months, and for booster vaccination in children who previously received this vaccine or a similar vaccine when they were younger.
When a dose of Tetravac is administered, the body's natural defenses will develop protection against these different diseases.

• Diphtheria is an infectious disease that usually initially affects the throat. In the throat, the infection causes pain and swelling that may lead to suffocation. The bacteria responsible for the disease also produce a toxin (poison) that can damage the heart, kidneys, and nerves.
• Tetanus (often described as "lockjaw") is caused by tetanus bacteria entering through a deep wound. The bacteria produce a toxin (poison) that causes muscle spasms, leading to inability to breathe and potential suffocation.
• Pertussis (often called whooping cough) is an infection of the airways, which can occur at any age but most frequently affects infants and young children. Characteristic symptoms include increasingly severe and frequent coughing fits, which may last for several weeks. Coughing fits may be followed by a whooping sound.
• Poliomyelitis (often referred to simply as polio) is a viral disease that affects the nerves. It may lead to paralysis or muscle weakness, usually in the legs. Paralysis of the muscles controlling breathing and swallowing may be fatal.

Important
Tetravac will help prevent these diseases only if they are caused by the same bacteria or viruses used to produce the vaccine. Your child may still contract these infectious diseases if they are caused by different viruses or bacteria.

2. What you should know before Tetravac is given to your child

It is important to inform the doctor, pharmacist, or healthcare professional if any of the points listed below
apply to your child, so that they can ensure Tetravac can be safely administered to your child.
Do not use Tetravac

• if your child is allergic to: the active substances of Tetravac or any of the excipients of Tetravac (see section 6), other vaccines containing any of the substances listed in section 6, or any vaccine protecting against pertussis (whooping cough);
• if your child has an active brain disease (progressive encephalopathy);
• if your child has had a severe reaction affecting the brain after any vaccine protecting against pertussis.

Warnings and precautions
Inform the doctor or healthcare professional before vaccination:

• If your child has a fever or an acute illness (e.g., fever, sore throat, cough, cold, or flu). Vaccination may need to be postponed until your child feels better.
• If your child previously received a pertussis vaccine and any of the following events occurred within 48 hours after vaccination: Fever of 40°C or higher, not due to another identifiable cause; collapse or shock-like state with hypotonic-hyporesponsive episode within 48 hours of vaccination; persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination; seizures with or without fever occurring within 3 days of vaccination.
• If your child is allergic (hypersensitive) to glutaraldehyde, neomycin, streptomycin, or polymyxin B. These substances are used in the production of Tetravac and may still be present in trace, non-measurable amounts in the vaccine.
• If your child has previously experienced febrile seizures unrelated to prior vaccination; in this case, it is particularly important that body temperature is monitored for 48 hours after vaccination and that antipyretic treatment is administered regularly to help reduce fever during this period.
• If your child has previously developed temporary loss of movement and sensation (Guillain-Barré syndrome) or loss of movement, pain, and numbness in the arm and shoulder (brachial neuritis) after a previous injection with a tetanus-containing vaccine; the doctor or nurse will decide whether to administer Tetravac to your child.
• If your child has immunodeficiency or is receiving treatment that suppresses their immune system, as the immune response to the vaccine may be reduced. It is recommended to wait until the end of such illness or treatment before vaccination. Administering Tetravac to children with chronic immunodeficiency (including HIV infection) is recommended, but protection against infection may be limited.
• If your child has thrombocytopenia (low platelet count) or bleeding disorders (such as haemophilia), as bleeding may occur at the injection site.

Fainting may occur following, or even before, any injection with a needle. Therefore, inform the doctor or nurse if your child has fainted after a previous injection.
Other medicines/vaccines and Tetravac
Tetravac may be administered simultaneously with:

• Act-HIB (Haemophilus influenzae type b conjugate vaccine)
• Vaccines containing measles-mumps-rubella and varicella
• Hepatitis B vaccine, but at separate injection sites.

If your child needs to receive Tetravac at the same time as other vaccines not listed above, consult your doctor or pharmacist for further information.
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Not applicable. This vaccine is intended for pediatric use only.
Tetravac contains phenylalanine, ethanol, and sodium
Tetravac contains 12.5 micrograms of phenylalanine per 0.5 mL dose. Phenylalanine may be harmful if the child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly process it.
Tetravac contains 2 mg of alcohol (ethanol) per 0.5 mL dose. The small amount of alcohol in this medicine will not have any noticeable effects.
Tetravac contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to administer Tetravac

Always use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
Dosage:
Primary vaccination and first booster:
Schedules include primary vaccination consisting of:

• two injections (with an interval of at least two months),
• or three injections (with an interval of at least one month), followed by a booster vaccination starting from the age of 12 months.

Additional booster vaccination:
An additional booster dose is recommended between 4 and 13 years of age.
This vaccine should be used in accordance with official recommendations.
Method of administration:
The vaccine must be administered by a doctor or healthcare professional trained in the use of vaccines and equipped to manage any rare severe allergic reactions that may occur after injection.
Tetravac is administered by injection into a muscle [intramuscular (IM)] in the upper thigh or upper arm of your child. The vaccine must never be administered into a blood vessel.
If your child misses a dose of Tetravac
If your child misses a scheduled injection, your doctor will decide when to administer the missed dose.
If you use more Tetravac than you should
Since a doctor or nurse administers Tetravac to your child, overdose is unlikely. If you think your child has received too much Tetravac or that the interval between two injections was too short, inform the doctor or nurse.
If you have further questions about the use of this medicine, ask your doctor, healthcare professional, or pharmacist.

4. Possible side effects

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

Serious allergic reactions
If any of the following symptoms occur after you have left the place where your child was vaccinated, you must consult a doctor IMMEDIATELY.
There is a possibility (frequency unknown) of severe allergic reactions occurring after administration of any vaccine. These may include:

• Difficulty breathing
• Bluish discoloration of the tongue or lips
• Skin rash
• Swelling of the face, throat, or other parts of the body
• Low blood pressure causing dizziness or collapse.

When these signs or symptoms occur, they usually develop rapidly after the injection and while the child is still at the hospital or medical office.

Other side effects
If your child experiences any of the following side effects, or if you notice any side effects not listed in this leaflet, inform your doctor, nurse, or pharmacist.

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

  • Vomiting
  • Loss of appetite (feeding disturbances)
  • Sleepiness (lethargy)
  • Headache
  • Nervousness (irritability)
  • Abnormal crying
  • Muscle pain (myalgia)
  • Redness at the injection site
  • Pain at the injection site
  • Swelling at the injection site
  • Fever equal to or greater than 38°C
  • Malaise.

• Common side effects (may affect 1 in 100 users) are:

  • Diarrhea
  • Sleep disturbances (insomnia)
  • Hardening of the skin at the injection site.

• Uncommon side effects (may affect 1 in 1,000 users) are:

  • Prolonged, inconsolable crying
  • Redness and swelling larger than 5 cm at the injection site
  • Fever equal to or greater than 39°C.

• Rare side effects (may affect from 1 to 10 in 10,000 users) are:

  • Fever above 40°C.

• Side effects with unknown frequency (frequency cannot be estimated from available data) are:

  • Fits (convulsions) with or without fever
  • Fainting (syncope)
  • Skin rash, redness, and itching of the skin (erythema, urticaria)
  • Extensive reactions at the injection site (>5 cm), including extensive swelling of the limb from the injection site extending beyond one or both joints. These reactions occur within 24–72 hours after vaccination, may be associated with redness, warmth, tenderness, or pain at the injection site, and resolve spontaneously within 3–5 days without the need for specific treatment. The risk appears to depend on the number of previous doses of acellular pertussis-containing vaccines, with a higher risk after the 4th and 5th doses.
  • Swelling of glands in the neck, armpits, or groin (lymphadenopathy).

Other reactions that may occur when Tetravac is administered simultaneously with the Haemophilus influenzae type b vaccine:

• Swelling of one or both lower limbs. This may occur together with bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura), and intense crying. If this reaction occurs, it happens mainly after the first (primary) injections, within the first hours after vaccination. All symptoms will completely disappear within 24 hours without the need for specific treatment.

Potential side effects (i.e., not directly reported with Tetravac, but reported with other vaccines containing one or more of the antigenic components of Tetravac) include:

• Temporary loss of movement or sensation (Guillain-Barré syndrome) and loss of movement, pain, and numbness (brachial neuritis) of the arm and shoulder.
• Episodes in which your child becomes limp, pale, and unresponsive for a period of time (hypotonic-hyporesponsive episodes).
• In infants born very prematurely (at 28 weeks of gestation or earlier), longer than normal intervals between breaths may be observed for 2–3 days after vaccination.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Tetravac

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Do not use this medicine after the expiry date stated on the label and carton after the word "EXP." The expiry date refers to the last day of the month indicated.
Do not dispose of any medicine via wastewater 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 Tetravac contains
The active substances are:
One dose (0.5 mL) contains:
Diphtheria toxoid not less than 20 IU (30 Lf)
Tetanus toxoid not less than 40 IU (10 Lf)
Bordetella pertussis antigens
Pertussis toxoid ……… 25 micrograms
Filamentous haemagglutinin ...... 25 micrograms
Inactivated poliovirus
Type 1 (Mahoney) 29 D-antigen units
Type 2 (MEF-1) 7 D-antigen units
Type 3 (Saukett) 26 D-antigen units
Adsorbed on hydrated aluminium hydroxide (0.3 mg Al)
As lower confidence limit (p = 0.95) and not less than 30 IU as mean value
Or equivalent activity determined by immunogenicity assessment
As lower confidence limit (p = 0.95)
Cultivated on Vero cells
These quantities of antigen are strictly equivalent to those previously expressed as 40-8-32 D-antigen units, respectively for type 1, 2 and 3 viruses, when measured by another suitable immunochemical method.
Aluminium hydroxide is included in this vaccine as an adsorbent. Adsorbents are substances included in some vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.

The other excipients are: Medium 199 Hanks without phenol red (a complex mixture of amino acids including phenylalanine, mineral salts, vitamins and other substances such as glucose), formaldehyde, glacial acetic acid and/or sodium hydroxide for pH adjustment, phenoxyethanol, anhydrous ethanol and water for injections.
The vaccine may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B, which are used during the manufacturing process.

Description of the appearance of Tetravac and contents of the pack
Tetravac, injectable suspension, is available in single-dose pre-filled syringes (0.5 mL).
Packs contain 1 or 10 syringes, without needle, with pre-attached needle, or with 1 or 2 needles supplied separately.
Not all pack sizes may be marketed.

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

Manufacturer
The manufacturer responsible for batch release is Sanofi Pasteur, with legal address:
Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon
(France)

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

The following information is intended exclusively for healthcare professionals

Instructions for use – Tetravac, injectable suspension.
Adsorbed diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine.
For syringes without attached needles, the separate needle must be firmly inserted into the syringe by rotating it one-quarter turn.
Shake well before injection until a homogeneous, white, cloudy suspension is obtained.
Visually inspect the suspension before administration. If extraneous particulate matter is present and/or any change in physical appearance is observed, discard the prefilled syringe.

Tetravac may be administered by reconstituting the Act-HIB vaccine (Haemophilus influenzae type b conjugate) as follows:
Shake the prefilled syringe until the contents become homogeneous, and reconstitute the solution by injecting the combined diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine suspension into the vial containing the Haemophilus type b conjugate vaccine powder.

• Gently shake the vial until the powder is completely dissolved. After reconstitution, a white, cloudy appearance of the suspension is normal.
• Immediately withdraw the reconstituted suspension into the syringe.
• The white, cloudy suspension must be used immediately after reconstitution and shaken well before injection.
• After reconstitution and withdrawal into the syringe, separation of the suspension into a clear phase and a gel-like phase may occur.

In such a case, the syringe must be shaken vigorously again before administration.
Tetravac must be administered by intramuscular injection. The recommended injection sites are the anterolateral aspect of the upper thigh in infants and young children, and the deltoid muscle in older children.