TetraXim injectable suspension in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tetraxim, injectable suspension in pre-filled syringe

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

Please read all of this leaflet carefully before your child is vaccinated because it contains important information.

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

Leaflet Contents

1. What Tetraxim is and what it is used for

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

3. How to use Tetraxim

4. Possible side effects

5. How to store Tetraxim

6. Contents of the pack and other information

1. What Tetraxim is and what it is used for

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

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

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

When a dose of Tetraxim is given, the body's natural defenses produce protection against these different diseases.

• Diphtheria is an infectious disease that usually first affects the throat. In the throat, the infection causes pain and swelling that can lead to suffocation. The bacteria causing the disease also produce a toxin (poison) that can damage the heart, kidneys, and nerves.
• Tetanus (often called lockjaw) is caused by tetanus bacteria entering a deep wound. The bacteria produce a toxin (poison) that causes muscle spasms that prevent breathing and can lead to suffocation.
• Pertussis (often called whooping cough) is a respiratory tract infection that can occur at any age but mainly affects infants and young children. The disease is characterized by increasingly severe coughing fits that can last for several weeks. Coughing spells may be followed by a whooping sound.
• 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 muscles controlling 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 make the vaccine. Your child may still contract infectious diseases if they are caused by other bacteria or viruses.

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

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

Do not use Tetraxim

• if your child is allergic to:

• the active substances of Tetraxim or to any of the other components of Tetraxim (see section 6)

• other vaccines containing any of the components listed in section 6

• any vaccine protecting against whooping cough

• if your child has an active brain disease (progressive encephalopathy);

• if your child has had a severe reaction to any whooping cough vaccine affecting the brain.

Warnings and precautions

Inform 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). Vaccination may need to be postponed until the child is better.

• If your child has previously received a vaccine protecting against whooping cough and any of the following occurred shortly afterwards:

• Fever of 40°C or higher within 48 hours, not due to another identifiable cause.

• Collapse or shock-like state with episodes of hypotonia and hyporesponsiveness within 48 hours after vaccination.

• Persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours after vaccination.

• Seizures with or without fever occurring within 3 days after vaccination.

• If your child is allergic (hypersensitive) to glutaraldehyde, neomycin, streptomycin, or polymyxin B. This is because these substances are used during the production of Tetraxim, and undetectable traces of these substances may still be present in the vaccine.

• If your child has had febrile seizures unrelated to a previous vaccination; in this case, it is particularly important that body temperature is monitored during the 48 hours following vaccination and that antipyretic treatment is administered regularly to help reduce fever over 48 hours.

• If your child has 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) after a previous injection with a tetanus toxoid-containing vaccine. Your doctor or nurse will decide whether Tetraxim should be administered 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. However, Tetraxim is recommended for children with chronic immunodeficiency (including HIV infection), although protection against infections may be limited.

• If your child has thrombocytopenia (low platelet levels) or a bleeding disorder (such as haemophilia), as bleeding may occur at the injection site.

Fainting may occur after any injection with a needle, or even before. Therefore, inform your doctor or nurse if you or your child has previously fainted after an injection.

Other medicines/vaccines and Tetraxim

Tetraxim can be administered at the same time as:

• Act-HIB (Haemophilus influenzae type b conjugate vaccine)
• Measles, mumps, rubella, and varicella vaccines
• Hepatitis B vaccine

but at separate injection sites.

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

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

Pregnancy and lactation

Not applicable. This vaccine is intended for children only.

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 properly eliminate it.

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., essentially "sodium-free".

3. How to use Tetraxim

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

Dosage:

Primary vaccination and first booster dose:

The vaccination schedule includes primary vaccination, which consists of:

• two injections (administered at least two months apart)
• or three injections (administered at least one month apart), followed by a booster dose starting at 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 follow official recommendations.

Method of administration:

Vaccination must be administered by medical or healthcare professionals trained in the use of vaccines and equipped to manage any rare serious allergic reaction to the injection.

Tetraxim is given as an injection into a muscle [intramuscular (IM) route] in the upper leg or arm of your child. The vaccine must 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 you use more Tetraxim than you should

Since Tetraxim is administered to your child by a doctor or nurse, overdose is unlikely. If you think your child received too much Tetraxim or if the interval between two injections was too short, inform your doctor or nurse.

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

4. Possible adverse effects

Like all vaccines and medicines, Tetraxim may cause adverse effects, although not everyone experiences 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 administration of any vaccine is very rare (affecting less than 1 in 10,000 people), and the frequency is unknown. These reactions may include:

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

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

Other adverse effects

If your child experiences any of the following adverse effects and they worsen, or if you notice any adverse effects not listed in this leaflet, consult your doctor, nurse, or pharmacist.

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

• Vomiting

• Loss of appetite (feeding disturbances)

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

• Diarrhea

• Insomnia (sleep disorders) (insomnia)

• Hardening of the skin (induration at the injection site)

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

• Prolonged, inconsolable crying

• Redness and swelling greater than 5 cm at the injection site

• Fever of 39 °C or higher

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

• Fever above 40°C

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

• Seizures, with or without fever

• Fainting (syncope)

• Skin rash, redness, and itching (erythema, urticaria)

• Large injection site reactions (greater than 5 cm), extensive limb swelling extending from the injection site beyond one or both adjacent joints. These reactions occur within 24–72 hours after vaccination, may be associated with redness, warmth, tenderness, or pain at the injection site, and usually resolve within 3–5 days without treatment. The risk appears to depend on the number of prior doses of acellular pertussis-containing vaccines, with a higher risk after the 4th and 5th doses.

• Swelling of the glands in the neck, armpit, or groin (lymphadenopathy)

Another reaction that may occur when Tetraxim is administered simultaneously with another Haemophilus influenzae type b vaccine:

• 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 happens mainly after the first injections (primary doses) and is observed within the first few hours after vaccination. All symptoms will completely resolve within 24 hours without treatment.

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

• Temporary loss of movement or sensation (Guillain-Barré syndrome) and loss of movement, pain, and numbness (brachial neuritis) in the arm and shoulder.
• Episodes in which your child goes into shock or appears pale, limp, and unresponsive for a period of time (hypotonic-hyporesponsive episodes).
• In children born very prematurely (at 28 weeks of gestation or earlier), abnormally long pauses between breaths may occur during the 2–3 days following vaccination.

Reporting of adverse effects

If your child experiences any adverse effects, consult your child's doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you 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 on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tetraxim

• Active substances:

One dose (0.5 mL) contains:

Diphtheria toxoid¹ not less than 20 IU^2,3 (30 Lf)
Tetanus toxoid¹ not less than 40 IU^3,4 (10 Lf)

Bordetella pertussis antigens:
Pertussis toxoid¹ 25 micrograms
Filamentous haemagglutinin¹ 25 micrograms

Inactivated poliovirus:
Type 1 (Mahoney)⁴ 29 antigen D units⁶
Type 2 (MEF-1)⁴ 7 antigen D units⁶
Type 3 (Saukett)⁴ 26 antigen D units⁶

1 Adsorbed on hydrated aluminium hydroxide (0.3 milligrams Al³⁺)
2 As lower confidence limit (p = 0.95) and not less than 30 IU as mean value
3 Or equivalent activity determined by immunogenicity assessment
4 As lower confidence limit (p = 0.95)
5 Grown on Vero cells
6 These antigen quantities are strictly identical to those previously expressed as 40-8-32 antigen D units for types 1, 2 and 3 respectively, when measured by another suitable immunochemical method.

Aluminium hydroxide is included in this vaccine as an adsorbent. Adsorbents are substances added to certain vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

• Other components: Hanks 199 medium 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 trace amounts of glutaraldehyde, neomycin, streptomycin, and polymyxin B, which are used during the manufacturing process.

Presentation of the Product and Contents of the Package

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

Pack sizes of 1 or 10 syringes: without needle, with fixed needle, with 1 separate needle, or with 2 separate needles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:

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 name:

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

Date of most recent review of this summary: 08/2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Instructions for Use – Tetraxim, injectable suspension

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

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

Shake well before injection until a homogeneous, slightly opaque, whitish suspension is obtained.

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

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

Shake the pre-filled syringe until the contents become homogeneous, and reconstitute the solution by injecting the combined diphtheria, tetanus, acellular pertussis and inactivated 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 slightly opaque, whitish appearance of the suspension is normal.
• Immediately withdraw the reconstituted suspension into the syringe.
• The reconstituted whitish, 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 gelatinous phase may occur.

In such cases, the syringe must be shaken vigorously again before administration.

Tetraxim must be administered by intramuscular injection. Recommended injection sites are the anterolateral aspect of the upper thigh in infants and the deltoid muscle in older children.