Infanrix Hexa, 0.5 ml syringe

Infantrix complies with WHO requirements for the production of biologics and vaccines against diphtheria, tetanus and pertussis.

One month after the three-dose course of initial Infantrix vaccination in the first months of life, more than 99% of children immunized with Infantrix vaccine have antibody titers to diphtheria and tetanus anatoxins greater than 0.1 IU/ml.
Antibodies to pertussis antigens (CA, FHA and pertactin) are produced in more than 95% of vaccinated children.

After revaccination with Infantrix vaccine in the second year of life (13 to 24 months), all children who were initially immunized with Infantrix vaccine have antibody titers of more than 0.1 IU/ml for diphtheria and tetanus toxoids.

The secondary immune response to pertussis antigens occurs in more than 96% of children.

The protective efficacy of the Infanrix vaccine reaches an average of 88%.

Indications

Primary vaccination against diphtheria, tetanus and whooping cough for children from 3 months.
Revaccination of children who have previously been immunized with three doses of acellular pertussis-diphtheria-tetanus or whole-cell pertussis-diphtheria-tetanus vaccine.
When starting a course of vaccination with whole-cell pertussis-diphtheria-tetanus vaccine, subsequent doses of acellular pertussis-diphtheria-tetanus vaccine can be administered and vice versa.

Pharmacological effect

Infanrix meets WHO requirements for the production of biological substances and vaccines against diphtheria, tetanus and pertussis.

1 month after a three-dose course of primary vaccination with Infanrix, carried out in the first months of life, in more than 99% of children immunized with the Infanrix vaccine, antibody titers to diphtheria and tetanus toxoids are more than 0.1 IU/ml.
Antibodies to pertussis antigens (CA, PHA and pertactin) are produced in more than 95% of vaccinated people.

After revaccination with the Infanrix vaccine in the second year of life (13 – 24 months), in all children who were primarily immunized with the Infanrix vaccine, antibody titers to diphtheria and tetanus toxoids are more than 0.1 IU/ml.

A secondary immune response to pertussis antigens occurs in more than 96% of children.

The protective effectiveness of the Infanrix vaccine reaches an average of 88%.

Special instructions

The vaccine should be administered with caution to persons with thrombocytopenia or hematopoietic dysfunction, as such patients are at risk of bleeding after IM injection.

Active ingredient

Vaccine for the prevention of diphtheria, whooping cough, polio, tetanus and Haemophilus Influenzae infections

Composition

One dose (0.5 ml) contains:

Contraindications

Known hypersensitivity to any component of this vaccine, or if the patient has experienced symptoms of hypersensitivity after a previous administration of Infanrix.
Severe reaction (temperature above 40°C, hyperemia or swelling more than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; continuous crying lasting 3 hours or more that occurred within 48 hours after vaccine administration; convulsions, accompanied or not accompanied by a febrile state, that occurred within 3 days after vaccination) to a previous vaccine administration Infanrix.
Encephalopathy that developed within 7 days after the previous administration of a vaccine containing a pertussis component. In this case, the vaccination course should be continued with diphtheria-tetanus vaccine.

Side Effects

Clinical trials
The following set of safety parameters is based on data obtained from immunization of more than 16,000 patients.
As with DTaP vaccine and combination vaccines that contain DTaP, an increase in the incidence of local reactogenicity and fever following booster vaccination with Infanrix Hexa was reported compared with the primary course.

Interaction

There is insufficient data regarding vaccine efficacy and safety for administering Infanrix Hexa vaccine concomitantly with measles/mumps/rubella vaccine to make appropriate recommendations.

Storage conditions

At 2–8 °C (do not freeze)

Shelf life

3 years

Manufacturer

GlaxoSmithKline Biologicals, France