INFANRIKS

Active material: difteriйnый toxoid, tetanus toxoid, pertussis toxoid, pertactin, filamentous hemagglutinin
When ATH: J07AJ52
CCF: A vaccine for the prevention of diphtheria, stolbnyaka, pertussis
Codes ICD-10 (testimony): Z27.1
When CSF: 14.03.01.10
Manufacturer: GlaxoSmithKline Biologicals s.a. (Belgium)

Pharmaceutical form, composition and packaging

Suspension for the / m cloudy, whitish, separate on standing into a colorless transparent liquid and a white precipitate, completely smashing with shaking.

Excipients: aluminum (hydroxide form) – 0.5 mg, 2-phenoxyethanol (preservative) – 2.5 mg, sodium chloride 4.5 mg, water d / and up 0.5 ml, formaldehyde (residual – no more 0.2 mg / ml).

The vaccine complies with the WHO in relation to the production of biological substances and vaccines against diphtheria, tetanus and pertussis.

0.5 ml (1 dose) – syringes of neutral glass bottle 1 ml (1) complete with needle (1 PC.) – blisters (1) – cardboard boxes.
0.5 ml (1 dose) – syringes of neutral glass bottle 1 ml (1) complete with needle (2 PC.) – blisters (1) – cardboard boxes.
0.5 ml (1 dose) – neutral glass syringes 1 ml (5) – blisters (2) complete with needle (2 blisters 5 PC.) – packs cardboard.
0.5 ml (1 dose) – neutral glass syringes 1 ml (5) – blisters (2) complete with needle (4 comics 5 PC.) – packs cardboard.

Pharmacological action

The vaccine against diphtheria, tetanus and pertussis.

The immune response to primary immunization

Through 1 trehdozovogo months after primary vaccination course, held in the first 6 months of life, more than 99% immunized vaccine Infanrix^® children antibody titers to diphtheria and tetanus toxoid account for more than 0.1 IU / mL. Antibodies to pertussis antigens (koklûšnyj toxoid / KA /, filamentous hemagglutinin / PHA / and pertactin) produced more than 95% grafted.

The immune response to a booster

After booster vaccine Infanrix^® on 2 year of life (13-24 of the month) all children, who were initially immunized with the vaccine Infanrix^®, antibody titers to diphtheria and tetanus toxoid account for more than 0.1 IU / mL. The secondary immune response to pertussis antigens observed in more than 96% children.

The protective efficacy of vaccine reaches an average 88%.

Pharmacokinetics

The data on the pharmacokinetics of the vaccine Infanrix^® not provided.

Testimony

- Primary vaccination against diphtheria, tetanus and whooping cough in children 3 months;

- Revaccination of children, which were previously immunized 3 doses of acellular pertussis-diphtheria-tetanus-whole cell pertussis or diphtheria-tetanus vaccine.

At the beginning of the course of whole-cell pertussis vaccine, diphtheria-tetanus vaccine, the introduction of subsequent doses of acellular pertussis-diphtheria-tetanus vaccine, and vice versa.

Dosage regimen

A single dose of the vaccine 0.5 ml.

Primary course of vaccination includes 3 vaccine doses, administered according to the national calendar of preventive vaccinations in Russia 3, 4.5 and 6 months of life; revaccination is carried out in 18 months.

Before the introduction of the vaccine is well shaken until a uniform cloudy suspension and carefully browsing. In case of detection of foreign particles, nonseparating flakes or change the appearance of the vaccine is not used.

The vaccine Infanrix^® injected i / m, and the injection site alternated during the course of vaccination.

The vaccine Infanrix^® Under no circumstances should you give / in.

Side effect

Clinical studies

The safety profile, shown below, based on the data, obtained in more than 11 400 patients.

With the introduction of the vaccine Infanrix^® observed increased frequency of occurrence of local reactions and fever when administered to a booster dose after passage of the primary vaccination course.

The frequency of adverse reactions is determined as follows: Often (≥10%), often (≥1%, <10%), sometimes (≥0.1%, <1%), rarely (≥0.01%, <0.1%), rarely (<0.01%).

From the lymphatic system: rarely – lymphadenopathy¹.

From the nervous system and psyche: Often – irritability, drowsiness; often – anxiety², unusual crying; sometimes – headache¹.

The respiratory system: sometimes – cough¹, bronchitis¹, rhinitis, pharyngitis.

From the digestive system: often – loss of appetite², gastrointestinal disorders (diarrhea and vomiting).

On the part of the skin and its appendages: often – itch; sometimes – rash; rarely – hives, dermatitis.

General and local reactions: Often – redness, swelling at the injection site (≤ 50 mm), fever ≥38 ° C; often – soreness², swelling at the injection site (> 50 mm)³; sometimes – induration, feeling tired¹, fever ≥39.1 ° C, diffuse swelling at the injection site, in some cases, including nearby tissue.

Post-marketing surveillance

From the hematopoietic system: thrombocytopenia⁴.

On the part of the immune system: allergic reactions, including anaphylactic and anaphylactoid reactions.

From the nervous system: collapse or shock-like state (hypotensive-hyporesponsive episode), convulsions (with or without fever) during 2-3 Days after vaccination.

On the part of the skin and its appendages: angioedema.

The respiratory system: apnea.

General and local reactions: swelling at the injection site³.

Very rarely reported cases of otitis media.

¹ – only when administered a booster dose.

² – often with the introduction of a booster dose.

³ – children, have undergone primary vaccination acellular pertussis vaccine, there is a greater risk of swelling at the injection site after administration of a booster dose compared to children, have undergone whole-cell DTP primary vaccination vaccine. These reactions resolved, average, flow 4 days.

³ – children, have undergone primary vaccination acellular pertussis vaccine, there is a great likelihood of swelling at the injection site after administration of a booster dose, compared to children, have undergone primary vaccination whole-cell vaccines. Swelling at the injection site (>50 mm) and the surrounding area may occur more often (often and often, respectively), when a booster dose is administered at the age of 4 to 6 years. These reactions resolved spontaneously within 4 days.

⁴ – described for diphtheria and tetanus vaccines.

Contraindications

- Known hypersensitivity to any component of this vaccine, and in the case, If the patient has symptoms of hypersensitivity after previous administration of the vaccine Infanrix^®;

- Expressed reaction (temperature 40 ° C, redness or swelling more 8 cm diameter) or complication (collapse or shock-like state, develop within 48 hours after administration of the vaccine; continuous crying, lasting 3 h or more, arising during the 48 hours after administration of the vaccine; convulsions, accompanied or not accompanied by fever, arising during the 3 days after vaccination) the previous administration of the vaccine Infanrix^®;

- Encephalopathy, evolved in the 7 days after the previous administration of the vaccine, containing the pertussis component. In this case, the course of vaccination should continue to diphtheria-tetanus vaccine.

Cautions

Before vaccination the child should study history, paying attention to the previous administration of vaccines and related occurrence of adverse reactions, as well as to inspect.

The introduction of the vaccine should be postponed if the child has an acute illness, accompanied by fever. When an infectious disease in a mild form of vaccination can be carried out after the normalization of temperature.

As with the introduction of any other vaccine, should have ready all the necessary for the relief of a possible anaphylactic reaction to Infanrix^®. Therefore vaccinated should be under medical supervision for 30 min after immunization.

Infanriks^® should be used with caution in patients with thrombocytopenia or disorders of blood clotting, since such patients / m injection may cause bleeding. To prevent bleeding should be to put pressure on the injection site, not rubbing it, for not less than 2 m.

HIV infection is not a contraindication to vaccination.

With the introduction of the vaccine in patients, undergoing immunosuppressive therapy, or patients with immunodeficiency, adequate immune response may not be achieved.

If any of the side effects had a temporary connection with the introduction of whole-cell or acellular pertussis-diphtheria-tetanus vaccine, the decision to introduce the subsequent doses should be carefully considered. Exceptions are possible under certain environmental conditions, such as a high incidence of pertussis, the potential benefit prevails over potential risk, especially, If these undesired reactions has not been associated with persistent complications.

The following condition is a contraindication to the introduction of whole-cell DTP vaccines and can be attributed to the general precautions, incl. when administered DTaP vaccines:

- Temperature of 40.5 ° C and above for 48 hours after vaccination, not related to other causes, in addition to administration of the vaccine;

- Collapse or shock-like state (hypotonic-hyporesponsive episode), develop within 48 hours after administration of the vaccine;

- Continuous crying, lasting 3 h or more, arising during the 48 hours after administration of the vaccine;

- Seizures, accompanied or unaccompanied by fever, arising during the 3 days after vaccination.

In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, vaccine with pertussis (whole cell or acellular) should be postponed until stabilization. The decision on the appointment of a pertussis vaccine must be made on an individual basis after careful evaluation of the benefits and risks.

Have a history of febrile seizures, as well as a family history of seizures is not a contraindication, but it requires special attention.

It is necessary to take into account the potential risk of apnea and the need to monitor respiratory function for 48-72 hours during the course of the primary vaccination of children, born prematurely (≤ 28 weeks of gestation) and, especially, infants with respiratory distress syndrome. Given the need to vaccinate children in this group, vaccination should not be delayed or denied in its conduct.

Overdose

Data on overdose of the vaccine Infanrix^® not provided.

Drug Interactions

In accordance with the rules, adopted in Russia, Infanriks^® It may be administered simultaneously (one day) with other vaccines the National Immunization Schedule and inactivated vaccines calendar of preventive vaccination on epidemic indications. However, other vaccine should be administered to other parts of the body.

Allowed to mix the vaccine Infanrix^® vaccine Hiberiks^® (Haemophilus influenzae type b vaccine). When the solvent, attached to a vaccine Hiberiks^®, should be replaced by the vaccine Infanrix^®.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at a temperature of 2 ° to 8 ° C; Do not freeze. Shelf life – 3 year. The drug expired application can not be.

Transporting the drug carried in the same conditions.