TETRAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

2. What you need to know before Tetraxim is administered to your child

It is important that you inform your doctor, pharmacist, or nurse if any of the following points apply to your child so that they can make sure Tetraxim is suitable for your child.

Do not use Tetraxim

• if your child is allergic to:

• the active substances of Tetraxim or any of the other components of Tetraxim (see section 6)
• other vaccines that contain any of the components included in section 6
• any vaccine that protects against pertussis

• if your child has any active brain disease (evolving encephalopathy);
• if your child has had a severe reaction to any pertussis vaccine that affected the brain.

Warnings and precautions

Tell your doctor or nurse before vaccination:

• If your child has a fever or an acute illness (e.g., temperature, sore throat, cough, cold, or flu). It may be necessary to delay vaccination until the child is better.
• If your child has received a pertussis vaccine in the past and shortly after experienced any of the following:

• Fever of 40°C or higher in the 48 hours following that was not due to any other identifiable cause.
• Collapsing or a shock-like state with a hypotonic-hyporesponsive episode in the 48 hours following vaccination.
• Prolonged, inconsolable crying that lasted for 3 hours or more, and occurred within 48 hours of vaccination.
• Seizures with or without fever, that occurred within 3 days of vaccination.

• If your child is allergic (hypersensitive) to glutaraldehyde, neomycin, streptomycin, and polymyxin B. This is because these substances are used during the production of Tetraxim and there may be undetectable traces of these substances still in the vaccine.
• If your child has had febrile seizures, not related to a previous administration of the vaccine; in this case, it is particularly important that the temperature is controlled in the 48 hours following vaccination and that antipyretic treatment is administered regularly to help reduce fever during 48 hours.
• If your child has had a temporary loss of movement and sensation (Guillain-Barré syndrome) or loss of movement, pain, and numbness (brachial neuritis) of the arm and shoulder after a previous injection with a vaccine containing tetanus toxoid. Your doctor or nurse will decide whether to administer Tetraxim to your child.
• If your child has immunodeficiency or is receiving treatment that suppresses their immune system, as this may reduce the immune response to the vaccine. It is recommended to wait until the end of such illness or treatment before vaccination. It is recommended to administer Tetraxim to children with chronic immunodeficiency (including HIV infection), but protection against infections may be limited.
• If your child has thrombocytopenia (low platelet count) or a bleeding disorder (such as hemophilia) because they may bleed at the injection site.

After any injection with a needle, or even before, fainting can occur. Therefore, inform your doctor or nurse if you or your child has fainted with any previous injection.

Other medicines/vaccines and Tetraxim

Tetraxim can be administered at the same time as:

• Act-HIB (Haemophilus influenzae type b conjugate)
• Vaccines against measles, mumps, rubella, and varicella
• Hepatitis B vaccine

but in separate injection sites.

Ask your doctor or pharmacist for more information if your child is given Tetraxim at the same time as any of the other vaccines mentioned.

Tell your doctor or pharmacist if your child is using, has recently used, or might use any other medicines.

Pregnancy and breastfeeding

Not applicable. This vaccine is intended only for children.

Tetraxim contains phenylalanine, ethanol, and sodium.

Tetraxim contains 12.5 micrograms of phenylalanine in each 0.5 ml dose. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Tetraxim contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol in this medicine will not produce noticeable effects.

Tetraxim contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially "sodium-free".

3. How to use Tetraxim

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor again.

Posology:

Primary vaccination and first booster dose:

The vaccination program includes primary vaccination, which consists of:

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

Additional booster vaccination

A booster dose is recommended between 4 and 13 years of age.

The use of this vaccine should be according to official recommendations.

Method of administration:

Vaccination should be administered by medically trained professionals or healthcare professionals trained in the use of vaccines and equipped to handle any unusual severe allergic reaction.

Tetraxim is administered as an injection into a muscle [intramuscularly (IM)] in the upper leg or arm of your child. The vaccine should never be administered into a blood vessel.

If your child misses a dose of Tetraxim

If your child misses a scheduled injection, your doctor will decide when to administer the missed dose.

If your child uses more Tetraxim than they should

Since your doctor or nurse administers Tetraxim to your child, it is unlikely that your child will receive too much Tetraxim. If you think that your child has received too much Tetraxim or the interval between two injections was too short, inform your doctor or nurse.

If you have any other questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

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

Severe allergic reactions

If any of these symptoms occur after leaving the place where your child received the injection, you must consult a doctor IMMEDIATELY.

The possibility of severe allergic reactions occurring after the administration of any vaccine is very rare (affects less than 1 in 10,000 people). These reactions can be:

• Difficulty breathing
• Bluish discoloration of the tongue or lips
• Rash
• Swelling of the face or throat or other parts of the body
• Drop in blood pressure that causes dizziness or fainting

When these signs and symptoms occur, they usually develop rapidly after the injection and while your child is still in the clinic or doctor's office.

Other side effects

If your child experiences any of the following side effects and they get worse or if you notice any side effect not mentioned in this leaflet, consult your doctor, nurse, or pharmacist.

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

• Vomiting
• Loss of appetite (feeding disorders)
• Drowsiness (somnolence)
• Headache
• Irritability
• Abnormal crying
• Muscle pain (myalgia)
• Redness at the injection site
• Pain at the injection site
• Swelling at the injection site
• Fever of 38°C or higher
• Malaise

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

• Diarrhea
• Insomnia (sleep disorders)
• Hardening of the skin (induration at the injection site)

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

• Prolonged, inconsolable crying

• Redness and swelling of more than 5 cm at the injection site
• Fever of 39°C or higher

• Rare side effects (may affect up to 1 in 1,000 people) are:

• Fever above 40°C

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

• Seizures (convulsions), with or without fever
• Fainting (syncope)
• Rash, redness, and itching of the skin (erythema, urticaria)
• Large reactions at the injection site (larger than 5 cm) extensive inflammation of the limbs from the injection site beyond one or both joints. These reactions occur within 24-72 hours after vaccination, may be associated with redness, heat, sensitivity, or pain at the injection site, and improve within 3-5 days without the need for treatment. The risk seems to depend on the number of previous doses of pertussis vaccines, with a higher risk after the 4th and 5th doses.
• Swelling of the lymph nodes in the neck, armpit, or groin (lymphadenopathy)

Another reaction that may occur when Tetraxim is administered at the same time as another vaccine against Haemophilus influenzaetype b:

• Swelling of one or both lower limbs. This may occur along 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 mainly occurs after the first injections (primaries) and is observed in the first hours after vaccination. All symptoms will disappear completely within 24 hours without the need for treatment.

Potential side effects(i.e., the following side effects have not been directly reported with Tetraxim, but have been reported with other vaccines that contain one or more of the antigenic components of Tetraxim) are:

• 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 enters a shock-like state or is pale, floppy, and unresponsive for a period of time (hypotonic-hyporesponsive episodes).
• In children born very prematurely (at 28 weeks of gestation or less), longer-than-normal intervals between breaths may occur during the 2-3 days following vaccination.

Reporting of side effects

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

5. Storage of Tetraxim

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

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

Do not freeze.

Do not use this medicine after the expiry date stated on the label and carton after EXP.

The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Tetraxim

• The active ingredients are:

A dose (0.5 ml) contains:

Diphtheria Toxoid1 not less than 20 UI2,3 (30 Lf)

Tetanus Toxoid1 not less than 40 UI3,4 (10 Lf)

Bordetella pertussisantigens

Pertussis Toxoid1 25 micrograms

Filamentous Hemagglutinin1 25 micrograms

Inactivated Poliovirus 5

Type 1 (Mahoney)4 29 units of antigen D6

Type 2 (MEF-1)4 7 units of antigen D6

Type 3 (Saukett) 4 26 units of antigen D6

1 Adsorbed on hydrated aluminum hydroxide (0.3 milligrams Al3+)

2 As a lower confidence limit (p = 0.95) and not less than 30 UI as a mean value

3 Or equivalent activity determined by immunogenicity evaluation

4 As a lower confidence limit (p = 0.95)

5 Grown in Vero cells

6 These antigen quantities 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 by another suitable immunochemical method.

This vaccine includes aluminum hydroxide as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

• The other components are: Hanks 199 medium without phenol red (a complex mixture of amino acids that includes phenylalanine, mineral salts, vitamins, and other substances such as glucose), formaldehyde, glacial acetic acid and/or sodium hydroxide to adjust the pH, phenoxyethanol, anhydrous ethanol, and water for injectable preparations.

The vaccine may contain traces of glutaraldehyde, neomycin, streptomycin, and polymyxin B used during the manufacturing process.

Appearance of the Product and Container Contents

Tetraxim, injectable suspension, is available in a single-dose pre-filled syringe (0.5 ml).

Container sizes of 1 or 10 without a needle, with a fixed needle, with 1 separate needle, or with 2 separate needles.

Only some container 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 Winthrop Industrie

Voie de l’Institut – Parc Industriel d’Incarville

B.P 101

27100 Val de Reuil

France

Local Representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Tetraxim: Croatia, Cyprus, Czech Republic, Hungary, Poland, Slovakia, Spain.

Date of the last revision of this leaflet: 08/2024

Detailed and updated information on this medicinal product 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 solely for healthcare professionals:

Instructions for use - Tetraxim, injectable suspension

Diphtheria, tetanus, pertussis (acellular component), and poliomyelitis (inactivated) vaccine, adsorbed.

For syringes without a fixed needle, the separate needle should be firmly attached to the syringe, turning it a quarter turn.

Shake before injection until a homogeneous, whitish-turbid suspension is obtained.

The suspension should be visually inspected before administration. If foreign particles and/or a change in physical appearance are observed, the pre-filled syringe should be discarded.

Tetraxim can be administered by reconstituting the Act-HIB vaccine (Haemophilus influenzae type b conjugate) as follows:

Shake the pre-filled syringe until the contents become homogeneous and reconstitute the solution by injecting the suspension of the combined vaccine against diphtheria, tetanus, pertussis, and poliomyelitis into the vial with the powder of the conjugate vaccine against Haemophilus type b.

• Gently shake the vial until the powder is completely dissolved. After reconstitution, the whitish-turbid appearance of the suspension is normal.
• Immediately withdraw the reconstituted suspension into the syringe.
• The whitish-turbid suspension should be used immediately after reconstitution and shaken before injection.
• After reconstitution and withdrawal into the syringe, separation of the suspension into a transparent phase and a gelatinous phase may occur.

In this case, the syringe should be shaken again vigorously before administration.

Tetraxim should be administered intramuscularly. The recommended injection sites are the anterolateral aspect of the upper thigh in infants and the deltoid muscle in older children.