TETRAXIM

Abbreviated Prescribing Information

See local Prescribing Information for full details prior to prescribing

1. TRADE NAME OF THE MEDICINAL PRODUCT AND PRESENTATION

TETRAXIM is presented in the form of a suspension for injection (0.5 mL in prefilled syringe-box of 1). Tetraxim contains Diphteria, Tetanus, Pertusis (Acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed). Component pertussis : Toxoid, Filamentous Haemagglutinin, The other ingredients are: aluminium hydroxide, Hanks medium (without phenol red), acetic acid and/or sodium hydroxide for pH adjustment, formaldehyde, phenoxyethanol and water for injections. Tetraxim is suspension for injection in prefilled syringe with whitish-turbid suspension.

2. THERAPEUTIC INDICATIONS

TETRAXIM is indicated in the joint prevention of diphtheria, tetanus, pertussis and poliomyelitis for booster vaccination between 5 and 13 years of age, according to official recommendations.

3. POSOLOGY AND METHOD OF ADMINISTRATION

Posology

For booster vaccination between 5 and 13 years of age: 1 injection.

Method of administration

Shake before injection until a homogenous whitish-turbid suspension is obtained. Administer by the intramuscular route.

Administration should preferably be performed in the anterolateral side of the thigh (middle third) in infants and in the deltoid area in children aged between 5 and 13 years.

4. CONTRA-INDICATIONS

If your child is allergic to one of the vaccine’s components or to pertussis vaccines (acellular or whole cells pertussis), or if your child experienced an allergic reaction after injection of a vaccine containing the same substances
Known hypersensitive to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present as traces)
If your child suffers from evolving encephalopathy (cerebral lesions)
If your child suffered from encephalopathy (cerebral lesions) within 7 days of a previous dose of a pertussis vaccine (acellular or whole cells pertussis)
If your child has a fever or an acute disease (the vaccination must be postponed).

5. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Make sure the vaccine is not injected by the intravascular route (the needle must not penetrate a blood vessel) nor by the intradermal route.
If your child suffers from thrombocytopenia or clotting problems as there is a risk of bleeding during intramuscular administration.
If your child already presented with febrile convulsions, not related to a previous vaccine injection; in this case it is particularly important that temperature be monitored in the 48 hours following vaccination and that antipyretic treatment be regularly administered to help reduce fever; for 48 hours.
If any of the following events are known to have occurred in temporal relation to receipt of vaccine (the decision to give further doses of pertussis-containing vaccine should be carefully considered):
Fever ≥ 400C within 48 hours not due to another identifiable cause.
Collapse or shock-like state with hypotonic-hypo responsive episode (drop in energy) within 48 hours of vaccination.
Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
Convulsions with or without fever; occurring within 3 days of vaccination.
If your child suffers/suffered from medical problems or allergic reactions, especially allergic reactions following injection of TETRAXIM.
If your child presented Guillain-Barre syndrome (abnormal sensitivity, paralysis) or brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following receipt of a prior vaccine containing tetanus toxoid should be evaluated by your doctor.
If your child presented edematous reactions (or swelling) occurring in the lower limbs after injection of a vaccine containing the Haemophilus influenzae type b valence the two vaccines, diphtheria-tetanus-pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine should be administered in two separate injection sites and on two different days,
If your child follows a treatment that suppresses her/his immune defenses or if your child presents with immunodeficiency: in these cases the immune response to the vaccine may be decreased. It is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.
A history of afebrile convulsions not related to a previous vaccine injection should be assessed by a specialist before deciding to vaccinate.
As with all injectable vaccines, appropriate medical treatment must be readily available and close supervision provided should a rare anaphylactic reaction occur following administration of the vaccine.

TETRAXIM contains phenylalanine, ethanol and sodium:

TETRAXIM contains 12.5 micrograms of phenylalanine in each 0.5 mL dose. Phenylalanine may be harmful for people who have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove 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 have any noticeable effects.
TETRAXIM contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

6. INTERACTIONS

TETRAXIM may be administered by reconstituting the Haemophilus influenzae type b conjugate vaccine (Act-HIB) or administered simultaneously with it in two separate injection site.

This vaccine can be administered simultaneously with the MMRV vaccine in two separate sites.

7. PREGNANCY AND LACTATION

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8. UNDESIRABLE EFFECTS

The most common reactions are: irritability, local reactions at the injection site such as redness and induration greater than 2 cm. These signs and symptoms usually occur within 48 hours following the vaccination and may continue for 48-72 hours. They resolve spontaneously without requiring specific treatment.

• Very common ≥ 10%

• Common ≥ 1% and < 10%

• Uncommon ≥ 0.1% and < 10%

Metabolism and nutrition disorders

Very common: loss of appetite

Psychiatric disorders

Very common: nervousness, irritability, abnormal crying

Common: insomnia, sleep disturbances

Nervous system disorders

Very common: somnolence, headache

Gastro-intestinal disorders

Very common: vomiting

Common: diarrhoea

Musculoskeletal and connective tissue disorders

Very common: myalgia

General disorders and administration site conditions

Very common: injection-site erythema, injection-site pain, injection-site oedema, fever ≥ 380C, malaise

Common: injection-site induration

For uncommon, rare and very rare side effects see full prescribing information

Potential undesirable effects (i.e. they have not been reported directly with TETRAXIM, but with other vaccines containing one or more of the antigenic constituents of TETRAXIM):

• Guillain-Barré Syndrome and brachial neuritis after administration of a tetanus toxoid-containing vaccine.

9. PHARMACODYNAMIC PROPERTIES

ATC Code: J07CA02.

Presentation: Box, 1 Prefilled syringe @ 0.5 ml (DKI1259703043A1)

Date of revision: 14 June 2023 (based on BPOM approval 02 June 2023)

This information is intended for Health Care Professional only. See local product information for full details information