Инфанрикс

Инфанрикс – the combined vaccine applied to prevention of tetanus, diphtheria and whooping cough.

Form of release and structure

Инфанрикс release in the form of suspension for intramuscular introduction: whitish color, muddy, divided when standing into transparent colourless liquid and a white deposit which when stirring completely breaks (in glass syringes on 1 ml, on 1, 2 or 5 syringes in blisters, on 1 or 2 blisters in a cardboard pack complete with needles).

Active agents are a part of 0,5 ml (1 doses) of suspension:

• Tetanic anatoxin – not less than 40 IU (international units);
• Diphtherial anatoxin – not less than 30 ME;
• Pertussoid anatoxin – 0,025 mg;
• Pertaktin – 0,008 mg;
• Hemagglutinin filamentozny – 0,025 mg.

Auxiliary components: 2 phenoxyethanol – 2,5 mg, aluminum – 0,5 mg (in the form of hydroxide), sodium chloride – 4,5 mg, water for injections – to 0,5 ml.

Indications to use

• Primary immunization of children since 3 months against tetanus, diphtheria and whooping cough;
• Revaccination earlier immunizirovanny three doses pertussoid and diphtheritic and tetanic (acellular or tselnokletochny) vaccines of children.

If at the beginning of carrying out a course of vaccination tselnokletochny pertussoid and diphtheritic and tetanic vaccines were used, further it is possible to apply acellular pertussoid and diphtheritic and tetanic vaccines and vice versa.

Contraindications

• The expressed reactions (with development of a hyperemia or hypostasis more than 8 cm in the diameter, temperature increase is above 40 °C) or complications (with development within 48 hours after administration of drug of shocklike states or a collapse, and also the continuous crying continuing of 3 o'clock; within 72 hours after vaccination – spasms with feverish states or without them) on the previous introduction of Infanriks;
• Encephalopathy which arose within 7 days after the previous introduction of a vaccine with the maintenance of a pertussoid component (in that case the course of vaccination needs to be continued, having excluded a pertussoid component, a diphtheritic and tetanic vaccine);
• The known hypersensitivity to drug components, and also in cases if the patient had hypersensitivity symptoms after the previous introduction of Infanriks.

Route of administration and dosage

Инфанрикс enter intramusculary, alternating during a course of vaccination of an injection site (intravenous administration of drug is contraindicated).

The single dose of Infanriks makes 0,5 ml.

Primary immunization includes 3 doses of a vaccine which enter with a break in 1,5 months (on the basis of the National calendar of preventive inoculations of Russia – in 3, 4,5 and 6 months of life of the child). The revaccination is carried out in a year after introduction of the last dose (at the age of 18 months).

Before introduction the syringe with suspension should be stirred up well before formation of muddy homogeneous liquid and to see attentively to exclude foreign particles, not breaking flakes or any changes of outward.

Side effects

During Infanriks's use development of disturbances from some systems of an organism is possible:

• Nervous system and mentality: very often – drowsiness, irritability; often – unusual crying, concern; sometimes – a headache;
• Lymphatic system: very seldom – a lymphadenopathy;
• Alimentary system: often – vomiting, appetite loss, diarrhea;
• Respiratory system: sometimes – pharyngitis, rhinitis, bronchitis, cough;
• Dermatological reactions: often – an itch; sometimes – rash; seldom – dermatitis, urticaria;
• Local and general reactions: very often – hypostasis and reddening in the place of an injection (up to 5 cm in size), fever (temperature is above 38 °C); often – morbidity, hypostasis in the place of an injection (the size more than 5 cm); sometimes – feeling of fatigue, fever (temperature more than 39,1 °C), consolidation in the place of an injection, the diffusion hypostasis in a vaccine injection site in certain cases including nearby fabrics.

When carrying out post-marketing observations development of the following side effects was noted:

• Respiratory system: apnoea;
• Nervous system: a collapse or a shocklike state (hypotensive гипореспонсивный an episode), spasms (with fever or without it) for 2-3 days after Infanriks's introduction;
• System of a hemopoiesis: thrombocytopenia;
• Local reactions: hypostasis in the place of an injection;
• Allergic reactions: Quincke's disease, hypersensitivity reactions, anaphylactoid and anaphylactic reactions;
• Others: very seldom – average otitis.

When carrying out in 18 months of a revaccination increase in frequency of cases of development of fever and local reactions was observed.

At children who completed a vaccination course an acellular pertussoid vaccine after introduction of a revaktsiniruyushchy dose the risk of edematization increases in the place of an injection in comparison with children to whom primary immunization was carried out by a tselnokletochny vaccine. As a rule, these reactions take place within 4 days independently.

Special instructions

Before Infanriks's use it is necessary to perform inspection and to study the anamnesis of the child, focusing attention to the previous introduction of vaccines and side reactions connected with it.

In the presence of an acute disease which is followed by temperature increase vaccination needs to be postponed. At the infectious diseases proceeding benign vaccination can be carried out after normalization of temperature.

After immunization vaccinated within 30 minutes has to be under medical observation (if necessary to stop anaphylactic reaction).

Инфанрикс apply with care at patients with thrombocytopenia or at disturbances of system of a blood coagulation (in such cases intramuscular administration of drug can become a bleeding origin). For prevention of bleeding it is necessary to press, without pounding, to the place of an injection, within at least 2 minutes.

HIV infection a contraindication to vaccination is not.

At Infanriks's introduction to patients with immunodeficiency or the patient which take a course of immunosuppressive therapy the proper immune response can be not reached.

Contraindications to introduction of the tselnokletochny adsorbed pertussoid and diphtheritic and tetanic vaccines (AKDS-vaccines) are the following states (they can be carried to general measures of precaution at Infanriks's introduction):

• Temperature from 40,5 °C within 48 hours after vaccination which is not connected with any other reasons except administration of drug;
• The continuous crying continuing of 3 o'clock, which arose within 48 hours after introduction of a vaccine;
• Shocklike state (hypotonic гипореспонсивный an episode) or the collapse which arose for 48 hours after introduction of a vaccine;
• Spasms which are followed by a feverish state or without them, arisen within 72 hours after vaccination.

Children with the progressing neurologic frustration, including uncontrollable epilepsy, infantile spasms or the progressing encephalopathy, need to postpone introduction of a vaccine with a pertussoid component (tselnokletochny or acellular) until stabilization of a state. The decision on a possibility of use of a vaccine with a pertussoid component should be made individually after careful assessment of advantage for health and possible risks.

In the presence of febrile spasms in the anamnesis, and also spasms in the family anamnesis of Infanriks it is possible to apply under special control.

When carrying out a course of primary immunization been born prematurely (up to 28 weeks of a gestation) children and especially children with respiratory a distress syndrome it is necessary to consider potential risk of development of an apnoea and to carry out breath function monitoring within 2-3 days.

Medicinal interaction

Инфанрикс it is possible to enter 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 (other vaccines need to be entered into other body parts).

Инфанрикс it is possible to mix with a vaccine of Hiberiks (against Haemophilus influenzae type b). At the same time the solvent attached to a vaccine by Hiberiks needs to be replaced with a vaccine of Infanriks.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 2-8 °C, not to freeze (transportation of drug should be carried out in the same conditions).

Period of validity – 3 years.