Product Information for the User

TetraximPre-filled Syringe Suspension

Diphtheria, Tetanus, Pertussis (acellular component) and Inactivated Poliomyelitis (adsorbed) Vaccine

Read this entire product information carefully before your child is vaccinated as it contains

important information.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This product has been prescribed only for your child, and should not be given to other people.
• If your child experiences any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this product information. See section 4.

6. Contents of the pack and additional information

Tetraxim is a vaccine (DTaP-IPV) used to protect against infectious diseases.

Tetraxim helps protect your child against diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis.

It is administered as primary vaccination in children from 2 months of age and as a booster vaccine in children who received this vaccine or a similar one when they were younger.

When Tetraxim is administered, the body's natural defenses produce protection against these different diseases.

• Diphtheria is an infectious disease that usually affects the throat first. In the throat, the infection causes pain and swelling that can lead to asphyxiation. The bacteria that cause the disease also produce a toxin (poison) that can damage the heart, kidneys, and nerves.
• Tetanus (often called locked jaw) is caused by the tetanus bacteria that enter a deep wound. The bacteria produce a toxin (poison) that causes muscle spasms that prevent breathing and can cause asphyxiation.
• Pertussis (often called whooping cough) is an infection of the respiratory tract that can appear at any age, but mainly affects infants and young children. The disease is characterized by increasingly intense coughing attacks that can last several weeks. Coughing attacks may be followed by a sound similar to a sneeze.
• Poliomyelitis (often called polio) is caused by viruses that affect the nerves. It can cause paralysis or muscle weakness, especially in the legs. Paralysis of the muscle that controls breathing and swallowing can be fatal.

Important

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

It is essential to inform your child's doctor, pharmacist, or nurse if any of the following points apply to your child so that they can ensure that Tetraxim is suitable for your child.

Do not use Tetraxim

• if your child is allergic to:

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

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

Warnings and precautions

Inform your child's doctor or nurse before vaccination:

• If your child has a fever or an acute illness (for example, temperature, sore throat, cough, cold, or flu). It may be necessary to postpone the vaccination until the child feels better.
• If your child has received a vaccine that protects against pertussis in the past and shortly afterwards experienced any of the following situations:

• Fever of 40°C or higher in the 48 hours following that was not due to another identifiable cause.
• Collapse or a state similar to shock with episode of hypotonia and hyporesponsiveness in the 48 hours following vaccination.
• Unconsolable crying, persistent that lasts for 3 hours or more, and that occurred in the 48 hours following vaccination.
• Convulsions with or without fever that occurred in the 3 days following 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 present in the vaccine.
• If your child has had febrile convulsions, not related to a previous administration of the vaccine; in this case, it is particularly important to control the temperature in the 48 hours following vaccination and to administer regular antipyretic treatment to help reduce the fever for 48 hours.
• If your child has had a temporary loss of movement and sensation (Guillain-Barré syndrome) or loss of movement, pain, and numbness of the arm and shoulder (brachial neuritis) 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 it may reduce the immune response to the vaccine. It is recommended to wait until the end of the disease or treatment before vaccination. It is recommended to administer Tetraxim to children with chronic immunodeficiency (including HIV infection), but the 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, dizziness may occur. Therefore, inform your child's doctor or nurse if you or your child has experienced dizziness 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
• Vaccine against Hepatitis B

but in separate injection sites.

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

Inform your child's doctor or pharmacist if your child is using, has used recently, or may need to use any other medicine.

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 your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it correctly.

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, that is, essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Dosage:

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 dose

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:

The vaccination should be administered by medical professionals or trained healthcare personnel equipped to handle any severe non-habitual allergic reaction to the injection.

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

If your child forgets a dose of Tetraxim

If your child forgets 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, an overdose is unlikely. If you believe your child 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 medication, ask your doctor, nurse, or pharmacist.

Like all vaccines and medicines, Tetraxim may cause side effects, although not everyone will experience them.

Severe allergic reactions

If any of these symptoms appear 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 fewer than 1 in 10,000 people). These reactions may be the following:

• Difficulty breathing
• Blue discoloration of the tongue or lips
• Rash
• Swelling of the face or throat or other parts of the body
• Drop in blood pressure causing dizziness or syncope

When these signs and symptoms appear, 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 worsen or if you notice any side effect not mentioned in this leaflet, consult your doctor, nurse or pharmacist.

• Very frequent reactions (may affect more than 1 in 10 people) are:

• Vomiting
• Loss of appetite (gastrointestinal disorders)
• Drowsiness (somnolence)
• Headache
• Nervousness (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
• Uncomfortable feeling

• Frequent reactions (may affect up to 1 in 10 people) are:

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

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

• Fever above 40°C

• Unknown frequency (the frequency cannot be estimated from the available data):

• Seizures (convulsions), with or without fever
• Syncope (fainting)
• 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 appear within 24-72 hours after vaccination, may be associated with redness, heat, sensitivity, or pain at the injection site, and improve in 3-5 days without the need for treatment. The risk seems to depend on the number of previous doses of vaccines containing acellular pertussis, 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 a vaccine against Haemophilus influenzae type b:

- Swelling of one or both lower limbs. This may occur along with blue discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura), and intense crying. If this reaction occurs, it mainly happens after the first injections (primaries) and is observed in the first hours after vaccination. All symptoms will disappear completely in 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) that would be the following:

• 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 state of shock or is pale, flaccid, and unresponsive for a period of time (hypotonic hyporeactive episodes).
• In children born very prematurely (at 28 weeks of gestation or earlier), there may be intervals between breaths that are longer than normal during the 2-3 days after vaccination.

Reporting of side effects

If your child experiences any type of side effect, consult the child's doctor,pharmacistor nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not freeze.

Do not use this medication after the expiration date indicated on the label and on the packaging after CAD.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.This will help protect the environment.

Composition of Tetraxim

• The active principles are:

A dose (0.5 ml) contains:

Diphtheria Toxoid1not less than 20 IU2,3 (30 Lf)

Tetanus Toxoid1not less than 40 IU3,4(10 Lf)

AntigensofBordetella pertussis

Pertussis Toxoid125 micrograms

Filamentous Haemagglutinin125 micrograms

Poliovirus (inactivated)5

Type 1 (Mahoney)429units of antigen D6

Type 2 (MEF-1)47units of antigen D6

Type 3 (Saukett)426 units of antigenD6

1Adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al3+)

2As lower confidence limit (p= 0.95) and not less than 30 IU as median value

3Or equivalent activity determined by immunogenicity evaluation

4As lower confidence limit (p=0.95)

5Cultivated in Vero cells

6These antigen amounts are strictly the same as those expressed earlier as 40-8-32 units of antigen D, for virus types 1, 2 and 3 respectively, when measured by another suitable immunochimical method.

This vaccine includes aluminium hydroxide as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.

• The other components are: Hanks 199 medium without red phenol (complex mixture of amino acids including phenylalanine, mineral salts, vitamins and other substances such as glucose), formaldehyde, glacial acetic acid and/or sodium hydroxide to adjust the pH, phenoxethanol, 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 contents of the package

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

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

The holder of the marketing authorization is:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

The responsible for manufacturing 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 with the following name:

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

Revision date of this leaflet: 08/2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for medical professionals or healthcare professionals:

Instructions for use - Tetraxim, injectable suspension

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

For syringes without fixed needle, the separate needle must be screwed firmly onto the syringe, turning it a quarter of a turn.

Shake before injection until a homogeneous white turbid suspension is obtained.

The suspension must be visually inspected before administration. In case of observing foreign particles and/or variation in physical appearance, discard the pre-filled syringe.

Tetraxim may be administered by reconstituting the vaccine Act-HIB (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 containing the powder of the conjugate vaccine against Haemophilus type b.

- Gently shake the vial until the powder is completely dissolved. After reconstitution, the white turbid appearance of the suspension is normal.

- Immediately withdraw the reconstituted suspension into the syringe.

- The white turbid suspension must be used immediately after reconstitution and shaken before injection.

- After reconstitution and withdrawal into the syringe, a separation of the suspension into a transparent phase and a gelatinous phase may appear.

In that case, the syringe must be shaken again vigorously before administration.

Tetraxim must be administered by intramuscular injection. The recommended injection sites are the antero-lateral surface of the upper thigh in infants and the deltoid muscle in older children.