Infantrix Hexa suspension, complete with lyophilizate, 1 dose 0.5ml syringes 1pc

Composition

One dose (0.5 ml) contains: diphtheria toxoid-not less than 30 Tetanus toxoid-not less than 40 pertussis toxoid (CA) – 25 mcg filamentous hemagglutinin (PHA) – 25 mcg outer membrane protein (pertactin) with a molecular weight of 69 kD – 8 mcg

Pharmacological action

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

1 month after the three-dose course of primary vaccination More than 99% of children immunized with the Infanrix vaccine have antibody titers to diphtheria and tetanus toxoids exceeding 0.1 IU / ml. Antibodies to pertussis antigens (KA, PHA, and pertactin) are produced in more than 95% of vaccinated individuals.

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

A secondary immune response to pertussis antigens occurs in more than 96% of children. Protective effectiveness of the vaccine Infanrix reaches an average of 88%.

Indications

• Primary vaccination against diphtheria, tetanus and pertussis in children from 3 months of age.
• Revaccination of children who were previously immunized with three doses of acellular pertussis-diphtheria-tetanus or whole-cell pertussis-diphtheria-tetanus vaccine.
• At the beginning of the whole-cell pertussis-diphtheria-tetanus vaccination course, subsequent doses of cell-free pertussis-diphtheria-tetanus vaccine may be administered and vice versa.

Contraindications

• Known hypersensitivity to any component of the current vaccine, as well as if the patient has experienced symptoms of hypersensitivity after a previous use of Infanrix.
• Strong reaction (temperature above 40°C, redness, or swelling for more than 8 cm in diameter) or complication (collapse or samopodoben condition that developed within 48 h after the introduction of the vaccine; persistent crying lasting 3 hours or more during the 48 hours after vaccination; seizures accompanied or not accompanied by a fever that occurred within 3 days after vaccination) to the previous use of the vaccine new year.
• Encephalopathy that developed within 7 days after the previous use of a vaccine containing a pertussis component. In this case, the course of vaccination should be continued with diphtheria-tetanus vaccine.

Side effects

Clinical trials The following set of safety parameters is based on data obtained from the immunization of more than 16,000 patients. As with the AaCDS vaccine and combination vaccines that contain AaCDS, an increase in the frequency of local reactogenicity and fever after booster vaccination with Infanrix Hexa was reported compared to the initial course. The following frequency of side effects per dose was determined: very often (>10%); often (>>1% and 0.1% and 0.01% and Infections and infestations Infrequently-upper respiratory tract infections. Metabolic and nutritional disorders Very often — loss of appetite. Mental disorders Very often — irritability, abnormal crying, anxiety; often —nervousness. From the nervous system, often-drowsiness; very rarely — convulsions (with or without fever). Respiratory, thoracic and mediastinal disorders are rare-bronchitis. Disorders of the gastrointestinal tract Often — vomiting, diarrhea. Impaired skin and subcutaneous tissue function Rarely — rashes; very rarely — dermatitis, urticaria**. General disorders and pathological reactions at the injection site Very often-pain, hyperemia, swelling at the injection site (38 °C, fatigue; often – swelling at the injection site ( 39.5 °C, pathological reactions at the injection site, including infiltration; infrequently-diffuse swelling of the limb into which the injection was performed, occasionally including the adjacent joint. Post-marketing pharmacovigilance Circulatory and lymphatic system disorders: Lymphadenopathy, thrombocytopenia. Immune disorders Allergic reactions (including anaphylactic and anaphylactoid reactions). Impaired cardiovascular function Collapse or shock-like state (hypotonic — hyporeactive episodes). General disorders and pathological reactions at the injection site Extensive swelling reactions, swelling of the entire injected limb**, vesicles at the injection site. * Children who received primary doses of acellular pertussis vaccine are more likely to develop swelling reactions after the booster dose than those who received whole-cell pertussis vaccines. These reactions resolve on average in 4 days. ** Observed with other AaCDS vaccines manufactured by GSK. Clinical experience of using the Infanrix Hexa vaccine with the hepatitis B vaccine It was reported that during the post — marketing pharmacovigilance after the introduction of the hepatitis B vaccine, children under 2 years of age experienced such side effects as paralysis, neuropathy, Guillaume-Barre syndrome, encephalopathy, encephalitis, meningitis. A causal relationship between these adverse events and the use of the vaccine has not been established.

Interaction

To provide appropriate recommendations, there is insufficient data on the efficacy and safety of the vaccine for the use of Infanrix Hexa at the same time as the measles/mumps/rubella vaccine. Data on the simultaneous use of the Infanrix Hexa vaccine and Prevnar/Prevenar (a vaccine based on a conjugated pneumococcal polysaccharide) indicate that there is no corresponding clinically significant cross-interaction of the immune response in the form of the production of antibodies to each of the individual antigens, provided that three doses of primary vaccination are administered. However, there are reports of a high incidence of fever (at body temperature >39.5 °C) in newborns who received Theinfanrix hexa and Prevnar/Prevenar vaccines, compared to those immunized with just one hexavalent vaccine. Treatment of fever should be initiated in accordance with local guidelines that relate to such treatment. As with other vaccines, it can be expected that patients who receive immunosuppressive therapy may not achieve an adequate immune response. Infanrix Hexa should not be mixed in the same syringe with any other vaccine.

How to take, course of use and dosage

A single dose of the vaccine is 0.5 ml. The course of primary vaccination consists of 3 doses of the vaccine, administered according to the National Calendar of Preventive Vaccinations of Russia at 3,4.5 and 6 months of life; revaccination is carried out at 18 months. Before use, the vaccine is shaken well until a homogeneous cloudy suspension is formed and carefully viewed. In case of detection of foreign particles, non-breaking flakes or changes in appearance, the vaccine is not used.

The Infanrix vaccine should be administered intramuscularly and alternate sites of use during the course of vaccination.

Under no circumstances should the vaccine be administered intravenously!

Special instructions

Patients with thrombocytopenia or impaired hematopoietic function should be given the vaccine with caution, as such patients are at risk of bleeding after IV injection. To prevent bleeding, apply pressure on the injection site, without rubbing, for 2 minutes.

Storage conditions

At a temperature of 2-8 °C (do not freeze)

Shelf life

3 years

Active ingredient

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

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection