CONTENTS

Diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine.

PRESENTATION

Prefilled syringe 0.5 mL x 1's.

DESCRIPTION

Each 0.5 mL dose contains the following active substances: Diphtheria toxoid ³30 iu, tetanus toxoid ³40 iu, Bordetella pertussis antigens (toxoid 25 mcg, filamentous haemagglutinin 25 mcg), inactivated type 1 poliomyelitis virus 40 DU*+, inactivated type 2 poliomyelitis virus 8 DU*+, inactivated type 3 poliomyelitis virus 32 DU*+.

*DU: D antigen unit.

+: Equivalent antigenic quantity determined by a suitable immunochemical method.

It also contains the following ingredients: Aluminium hydroxide, Hanks medium (without phenol red), acetic acid and/or sodium hydroxide for pH adjustment, formaldehyde, phenoxyethanol and water for injection.

INDICATIONS

Protection against diphtheria, tetanus, pertussis and poliomyelitis from the age of 2 months with primary vaccination and for booster vaccination during the 2nd year of life and between 5 and 13 years according to national official recommendations.

DOSAGE & ADMINISTRATION

The usual recommended schedule includes primary vaccination consisting of 3 injections at an interval of 1-2 months from the age of 2 months, followed by 1 booster injection 1 year after primary vaccination within the 2nd year of life and another one between 5 and 13 years according to national official recommendations.

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

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

If a dose of Tetraxim is missed, the doctor will decide when to administer the missing dose.

CONTRAINDICATIONS

Hypersensitivity to any of the components of Tetraxim or to pertussis vaccines (acellular or whole cell pertussis) or if the child experienced an allergic reaction after injection of a vaccine containing the same substances.

Evolving encephalopathy (cerebral lesions); encephalopathy (cerebral lesions) within 7 days of a previous dose of a pertussis vaccine (acellular or whole cell pertussis); fever or an acute disease (the vaccination must be postponed).

PRECAUTIONS

Make sure the vaccine is not injected by the intravascular route (the needle must not penetrate a blood vessel) nor by the intradermal route.

Thrombocytopenia or clotting problems, as there is a risk of bleeding during IM administration.

Hypersensitivity to glutaraldehyde, neomycin, streptomycin and polymyxin B, as these substances are used during the manufacturing process.

Febrile convulsions not related to a previous vaccine injection; in this case, it is particularly important that temperature be monitored in the 48 hrs following vaccination and that antipyretic treatment be regularly administered to help reduce fever for 48 hrs.

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 ³40°C within 48 hrs not due to another identifiable cause; collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hrs of vaccination; persistent, inconsolable crying lasting ³3 hrs, occurring within 48 hrs of vaccination; convulsions with or without fever, occurring within 3 days of vaccination; medical problems or allergic reactions, especially allergic reactions following injection of Tetraxim.

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 (vaccine against tetanus), the decision to give any further vaccine containing tetanus toxoid should be evaluated by the doctor.

Oedematous reactions (or swelling) occurring in the lower limbs after injection of a vaccine containing the Haemophilus influenzae type b valence, the 2 vaccines, diphtheria-tetanus-pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine should be administered in 2 separate injection sites and on 2 different days.

If the child follows a treatment that suppresses the immune defenses or if the child presents with immunodeficiency, 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 eg, HIV infection is recommended even if the antibody response may be limited.

SIDE EFFECTS

The most common reactions are: Irritability, local reactions at the injection site eg, redness and induration >2 cm. These signs and symptoms usually occur within 48 hrs following the vaccination and may continue for 48-72 hrs. They resolve spontaneously without requiring specific treatment.

In clinical studies, hypotonic-hyporesponsive episodes (hypotonic episodes, drop in energy, hyporesponsiveness, decreased mental awareness) have been reported after administration of pertussis-containing vaccines; they have not been reported with Tetraxim.

The following side effects have been reported: Erythema, induration, pain at the injection site, redness and oedema (swelling) ³5 cm at the injection site.

Oedema (swelling) >5 cm that may spread over the entire limb where the vaccine has been administered. This reaction occurs within 24-72 hrs after vaccination and resolves spontaneously within 3-5 days. The risk appears to be dependent on the number of prior doses of acellular pertussis-containing vaccines, with a greater risk following the 4th and 5th doses.

Fever sometimes above 40°C; diarrhoea; vomiting; loss of appetite; somnolence; convulsion with or without fever; nervousness, irritability; insomnia, sleep disturbances; abnormal crying, prolonged inconsolable crying; allergy-like symptoms eg, rash, erythema and urticaria.

Furthermore, oedematous reactions (swelling) affecting the lower limbs have been reported when Tetraxim is administered with Haemophilus influenzae type b containing vaccines. These reactions are sometimes accompanied by fever, pain and crying. They are not accompanied by cardio-respiratory signs.

Potential side effects (ie, they have not been reported directly with Tetraxim, but with other vaccines containing one or more of the antigenic constituents of Tetraxim) are the following: Guillain-Barre syndrome (abnormal sensitivity, paralysis) and brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following administration of a vaccine containing tetanus toxoid.

INTERACTIONS

For primary vaccination and for the 1st booster dose, Tetraxim may be administered by reconstituting the Haemophilus influenzae type b conjugate vaccine (Act-HIB) or administered simultaneously with it in 2 separate injection sites.

In case the child should receive Tetraxim simultaneously with other vaccines than those already mentioned, ask the doctor or pharmacist for more information.

Inform the doctor or pharmacist if the child has recently taken any other medicines, even those not prescribed.

CAUTIONS FOR USAGE

Instructions for Use and Handling: Do not use Tetraxim if abnormal colour or the presence of foreign particles are noticed.

STORAGE

Store in a refrigerator (2-8°C). Do not freeze.

Shelf-Life: 36 months.