Инфанрикс

General characteristics. Structure:

Suspension for introduction in oil muddy, whitish color, divided when standing into colourless transparent liquid and the white deposit which is completely breaking when stirring.

Active ingredient: diphtherial anatoxin not less than 30 ME
tetanic anatoxin not less than 40 ME
pertussoid anatoxin of 25 mkg
hemagglutinin of filamentozny 25 mkg
пертактин 8 mkg

Excipients: aluminum (in the form of hydroxide) - 0.5 mg, 2 phenoxyethanol (preservative) - 2.5 mg, sodium chloride - 4.5 mg, water for and - to 0.5 ml.

Pharmacological properties:

Vaccine against diphtheria, tetanus and whooping cough.

Immune response on primary immunization

In 1 month after the three-dose course of primary immunization conducted in the first 6 months of life, more than at 99% immunizirovanny the vaccine Infanriks® of children antiserum capacities to diphtheritic and tetanic anatoxins make more than 0.1 ME/ml. Antibodies to pertussoid antigens (pertussoid anatoxin/KA/, filamentozny hemagglutinin / FGA/and пертактин) are developed more than at 95% vaccinated.

Immune response on a revaccination

After a revaccination the vaccine Infanriks® on the 2nd year of life (13-24 months) at all children who were initially immunizirovana the vaccine Infanriks® antiserum capacities to diphtheritic and tetanic anatoxins make more than 0.1 ME/ml. The secondary immune response on pertussoid antigens is observed more than at 96% of children.

Protective immunological efficacy reaches on average 88%.

Pharmacokinetics. The vaccines Infanriks® given on pharmacokinetics are not provided.

Indications to use:

— primary immunization against diphtheria, tetanus and whooping cough at children since 3 months;

— a revaccination of children who were immunizirovana 3 doses of an acellular pertussoid and diphtheritic and tetanic or tselnokletochny pertussoid and diphtheritic and tetanic vaccine earlier.

At the beginning of a course of vaccination by a tselnokletochny pertussoid and diphtheritic and tetanic vaccine introduction of the subsequent doses of an acellular pertussoid diphtheritic-tetanic vaccine and vice versa is possible.

Route of administration and doses:

The single dose of a vaccine makes 0.5 ml.

The course of primary immunization consists of 3 doses of a vaccine entered according to the National calendar of preventive inoculations of Russia in 3, 4.5 and 6 months of life; the revaccination is carried out in 18 months.

Before introduction the vaccine is well stirred up before formation of homogeneous muddy suspension and attentively looked through. In case of detection of foreign particles, not breaking flakes or change of outward the vaccine is not used.

The vaccine Infanriks® is entered by in oil and alternate injection sites during a vaccination course.

The vaccine Infanriks® is not entered under no circumstances in / century.

Features of use:

Before vaccination it is necessary to study the anamnesis of the child, paying attention to the previous introduction of vaccines and the emergence of side reactions connected with it, and also to perform inspection.

Introduction of a vaccine should be postponed in the presence at the child of the acute disease which is followed by temperature increase. At an infectious disease benign vaccination can be carried out after normalization of temperature.

As well as at introduction of any other vaccines, it is necessary to have all necessary for stopping of possible anaphylactic reaction to Infanriks®. Therefore vaccinated has to be under medical observation within 30 min. after immunization.

Инфанрикс® it is necessary to apply with care at patients with thrombocytopenia or with disturbances of system of a blood coagulation as at such patients in oil the injection can become the bleeding reason. For prevention of bleeding it is necessary to press to the place of an injection, without pounding it, within not less than 2 min.

HIV infection is not a contraindication to vaccination.

At introduction of a vaccine to the patients taking a course of immunosuppressive therapy or patients with immunodeficiency, the adequate immune response can be not reached.

The following states are contraindications to introduction of tselnokletochny AKDS-vaccines and can be carried to general measures of precaution at introduction of the vaccine Infanriks®:

— temperature of 40.5 °C and above during 48 h after vaccination, not connected with other reasons, except introduction of a vaccine;

— the collapse or a shocklike state (hypotonic гипореспонсивный an episode) which developed during 48 h after introduction of a vaccine;

— the continuous crying lasting 3 h and more, which arose during 48 h after introduction of a vaccine;

— the spasms accompanied or unaccompanied a feverish state, arisen within 3 days after vaccination.

At children with the progressing neurologic frustration, including infantile spasms, uncontrollable epilepsy or the progressing encephalopathy, introduction of a vaccine with a pertussoid component (tselnokletochny or acellular) needs to be postponed until stabilization of a state. The decision on purpose of a vaccine with a pertussoid component has to be made on an individual basis after careful assessment of advantage and risks.

Existence of febrile spasms in the anamnesis, and also spasms in the family anamnesis is not a contraindication, but requires special attention.

It is necessary to consider potential risk of an apnoea and need of monitoring of respiratory function during 48-72 h when carrying out a course of primary immunization of the children who were born prematurely (≤ 28 weeks of a gestation) and, especially, children with respiratory a distress syndrome. In view of need of vaccination of children of this group, vaccination it is impossible to postpone or refuse its carrying out.

Side effects:

Clinical trials

The safety profile given below is based on the data obtained at more than 11 400 patients.

At introduction of a revaktsiniruyushchy dose of the vaccine Infanriks® in 18 months increase in frequency of cases of local reactions and fever was observed.

At the children who completed a vaccination course an acellular pertussoid vaccine the high probability of edematization in the place of an injection after introduction of a revaktsiniruyushchy dose, in comparison with the children who completed a course of primary immunization by a tselnokletochny vaccine is observed. These reactions are allowed independently within 4 days.

Determination of frequency of side reactions: very often (≥10%), it is frequent (≥1%, <10%), sometimes (≥0.1%, <1%), is rare (≥0.01%, <0.1%), is very rare (<0.01%).

From lymphatic system: very seldom - limfadenopatiya1.

From a nervous system and mentality: very often - irritability, drowsiness; often - bespokoystvo2, unusual crying; sometimes - head bol1.

From respiratory system: sometimes - kashel1, bronkhit1, rhinitis, pharyngitis.

From the alimentary system: often - loss appetita2, diarrhea, vomiting.

Dermatological reactions: often - an itch; sometimes - rash; seldom - urticaria, dermatitis.

General and local reactions: very often - reddening, swelled in the place of an injection (≤ 50 mm), fever of ≥38 °C; often - boleznennost2, swelled in the place of an injection (> 50 mm); sometimes - consolidation in the place of an injection, feeling ustalosti1, fever of ≥39.1 °C, diffusion hypostasis in the place of an injection, in certain cases including nearby fabrics.

Post-marketing observations

From system of a hemopoiesis: trombotsitopeniya3.

Allergic reactions: hypersensitivity reactions, Quincke's disease, anaphylactic and anaphylactoid reactions.

From a nervous system: a collapse or a shocklike state (hypotensive гипореспонсивный an episode), spasms (with fever or without) within 2-3 days after introduction of a vaccine.

From respiratory system: apnoea.

Local reactions: hypostasis in the place of an injection.

Others: very seldom - average otitis.

1 - only at introduction of a revaktsiniruyushchy dose.

2 - very often at introduction of a revaktsiniruyushchy dose.

3 - it is described for the vaccines containing diphtheritic and tetanic anatoxins.

Interaction with other medicines:

According to the rules accepted in Russia, Infanriks® can be entered at the same time (in one day) with other vaccines of the National calendar of preventive inoculations and the inactivated vaccines of a calendar of preventive inoculations according to epidemic indications. At the same time other vaccines should be entered into other body parts.

It is allowed to mix the vaccine Infanriks® with the vaccine Hiberiks® (a vaccine against Haemophilus influenzae type b). At the same time the solvent attached to the vaccine Hiberiks® should be replaced with the vaccine Infanriks®.

Contraindications:

— the known hypersensitivity to any component of the real vaccine and also if the patient had hypersensitivity symptoms after the previous introduction of the vaccine Infanriks®;

— the expressed reaction (temperature more than 40 °C, a hyperemia or hypostasis more than 8 cm in the diameter) or a complication (the collapse or a shocklike state which developed during 48 h after introduction of a vaccine; the continuous crying lasting 3 h and more, which arose during 48 h after introduction of a vaccine; the spasms which are followed or not followed by a feverish state, arose during 3 days after vaccination) on the previous introduction of the vaccine Infanriks®;

— the encephalopathy which developed within 7 days after the previous introduction of the vaccine containing a pertussoid component. In this case the course of vaccination should be continued by a diphtheritic and tetanic vaccine.

Overdose:

The vaccines Infanriks® given on overdose are not provided.

Storage conditions:

It is necessary to store drug in the place, unavailable to children, at a temperature from 2 ° to 8 °C; not to freeze. A period of validity - 3 years. Drug is not subject to expired use.

Transportation of drug is carried out in the same conditions.

Issue conditions:

According to the recipe

Packaging:

0.5 ml (1 dose) - syringes of neutral glass with a capacity of 1 ml (1) complete with needles (1 in the blister) - blisters (1) - boxes cardboard.
0.5 ml (1 dose) - syringes of neutral glass with a capacity of 1 ml (1) complete with needles (2 in the blister) - blisters (1) - boxes cardboard.
0.5 ml (1 dose) - syringes of neutral glass with a capacity of 1 ml (5) - blisters (2) complete with needles (2 strips on 5) - packs cardboard.
0.5 ml (1 dose) - syringes of neutral glass with a capacity of 1 ml (5) - blisters (2) complete with needles (4 strips on 5) - packs cardboard.

The vaccine conforms to requirements of WHO for production of substances of a biological origin and vaccines against diphtheria, tetanus and whooping cough.