Prevenar

General characteristics. Structure:

Active agents: Pneumococcal conjugates (polysaccharide + CRM197): Polysaccharide of a serotype of 4 - 2 mkg Polysaccharide of a serotype  6B - 4 of mkg Polysaccharide of a serotype 9V - 2 of mkg Polysaccharide of a serotype of 14 - 2 mkg Oligosaccharide of a serotype 18C - 2 of mkg Polysaccharide of a serotype 19F - 2 of mkg Polysaccharide of a serotype 23F - 2 of mkg  CRM 197 Carrier protein ~ 20 mkg Excipients: aluminum phosphate of 0,5 mg (in terms of aluminum of 0,125 mg), sodium chloride of 4,5 mg, water for injections to 0,5 ml.

Pharmacological properties:

The action mechanism the Vaccine Prevenar includes seven active agents representing the pneumococcal polysaccharides received from gram-positive bacteria  of Streptococcus pneumoniae, individually conjugated with diphtheritic CRM197 carrier protein, and adsorbed on aluminum phosphate. Introduction of a vaccine Prevenar causes development of antibodies to kapsulyarny  Streptococcus pneumoniae polysaccharides of serotypes 4, 6V, 9V, 14, 18S, 19F, 23F, providing specific protection of an organism against the infections caused by them. Immunological efficiency. Children of the first year have lives, since 2-month age, when using various schemes of vaccination, formation of a protective immune response after a series of primary immunization and a secondary immune response on the last dose is shown, i.e. at a revaccination. After введениятрех doses at primary immunization and the subsequent revaccination considerable rise in level of antibodies is noted. Prevenar induces formation of functional antibodies to all serotypes of a vaccine. At children aged from 2 up to 5 years the expressed antibody formation to all serotypes of a vaccine is observed after single introduction of Prevenar,  at the same time the immune response practically matched that at children of the first two years of life after a series of primary immunization. Efficiency at prevention of infectious diseases In the large-scale clinical trial of efficiency of immunization by Prevenar which is carried out to the USA which included more than 18000 children at the age of 2, 4, 6 and 12-15 months, is shown that specific  immunological efficacy for prevention of the invasive diseases of the pneumococcal nature (IDPN) made 97%, at coverage of 85% of these diseases at children  in the USA  and a little smaller in the European countries (65-80%). Efficiency at prevention of pneumonia Efficiency of preventive appointment of Prevenar concerning the bacterial pneumonia caused   by S.pneumoniae serotypes similar to a vaccine  made 87,5% . Efficiency at prevention of acute average otitis Prevenar's Efficiency at children at the age of 2, 4, 6 and 12-15 months concerning the acute average otitis (AAO) caused by the serotypes of pneumococci included in a vaccine makes about 54%. Among immunizirovanny children there is an incidence of OSO caused by the serotypes which are not included in a vaccine was 33% higher. Nevertheless, the cumulative positive preventive effect was expressed in decrease in incidence of pneumococcal OSO by 34%. The general decrease in number of cases of average otitis without an etiology made 6%. It is shown that Prevenar's efficiency at prevention of frequent otitises (at least 3 exacerbations of a disease within 6 months) made 18%, at recurrent OSO (3 aggravations in 6 months or 4 times a year) - 9% and 23% at OSO with a recurrence of 5 times in 6 months or 6 times a year, and 50% at exudative chronic average otitis. Need for carrying out a timpanostomiya at the children vaccinated by Prevenar decreased by 24 - 39%.

Indications to use:

Prevention of the diseases caused  by Streptococcus pneumoniae of serotypes 4, 6V, 9V, 14, 18S, 19F and 23F (including sepsis, meningitis, pneumonia, bacteremia and acute average otitis) at children aged from 2 months up to 5 years.

Route of administration and doses:

Before use of a vaccine Prevenar it is necessary to stir up syringe contents before receiving homogeneous suspension.  Not to use  if at survey of contents of the syringe foreign debris come to light or  contents look differently, than it is specified in the section "Description". The vaccine is entered only intramusculary into the perednebokovy surface of a hip (to children up to 2 years) or into a deltoid muscle of a shoulder (to children 2 years are more senior). Not to enter Prevenar intravenously! The scheme of vaccination of children Aged from 2 up to 6 months: three doses of a vaccine on 0,5 ml everyone, with an interval between doses not less than 1 month, the first dose is usually entered at the age of 2 months. The fourth dose (i.e. a revaccination) is recommended to be entered on the second year of life, it is optimum in 12-15 months. For children to whom vaccination was not begun in the 1st half-year of life Prevenar's appointment  is carried out according to schemes: Aged from 7 up to 11 months: 2 doses on 0,5 ml everyone, with an interval not less than 1 month between introductions. The third dose (i.e. a revaccination) is recommended on the second year of life. Aged from 12 up to 23 months: 2 doses on 0,5 ml everyone, with an interval to a muzhd introductions not less than 2 months. Aged from 2 up to 5 years: 1 dose of 0,5 ml once. The Nobkhodimost in any additional dose after each of the stated above schemes of immunization is not established.

Features of use:

Prevenar is not applied at adults. The uses of a vaccine given about safety Prevenar at pregnancy and in the period of a lactation otstutsvut. As well as when using other vaccines, Prevenar's introduction should be postponed if the patient has an acute disease which is followed by the moderated or expressed hyperthermia. As well as at use of other vaccines, on a case of development of possible exceptional cases of anaphylactic reactions within not less than 30 minutes after Prevenar's introduction the child has to  be under the corresponding medical observation. Due to the potential risk of an apnoea it is necessary to provide a possibility of observation of a condition of the patient within 48-72 hours at primary series of vaccination at children aged up to 28 weeks, especially in cases of immaturity of a respiratory organs in the anamnesis. As the advantage of vaccination at this group of patients is especially high, it is not necessary neither to refuse vaccination, nor to postpone its date. Prevenar does not provide protection against serotypes  of Streptococcus pneumoniae  which are not a part of a vaccine and also against other microorganisms causing invasive diseases or average otitis. Decrease in incidence of X-ray positive pneumonia at the children who underwent vaccination in comparison with nevatsinirovanny Prevenar was the greatest on the first year of life (32,2%) and within the first 2 years of life (23,4%).  Antibody formation on the vaccine against Hemophilus influenzae type b (Хиб) conjugated with tetanic protein on vaccines against tetanus and hepatitis B was same, as well as at individual introduction of these vaccines. For Hib-vaktsiny conjugated with diphtheritic protein CRM197 strengthening of development of antibodies to Hib and diphtheria at immunization of children of chest age is described. At a revaccination insignificant reduction of maintenance of antibodies to Hib with preservation of protective level is described. Non-constant decrease in the answer to pertussoid antigens, and also on the inactivated poliomyelitic vaccine (IPV) is described. There are limited data on combined use of Prevenar with a vaccine against measles, a rubella and parotitis, and also a vaccine against chicken pox. Experience of combined use of Prevenar with a hexavalent vaccine of Infanriks showed lack of clinically significant influence on antibody formation to each separate antigen after introduction of the third dose during primary immunization. Prevenar children should not appoint a vaccine with thrombocytopenia or other disturbances of coagulant system of blood to which intramuscular injections are contraindicated, except for cases when the potential advantage of use of a vaccine considerably surpasses the risk caused by introduction of a vaccine. Though at Prevenar's introduction antibody formation (are defined by a binding method) in response to diphtheritic CRM197 carrier protein, use of a vaccine is possible Prevenar cannot replace standard immunization against diphtheria.  CRM197 carrier protein is a gene-modified non-toxic form of diphtheritic toxin. Children with disturbances have immunoreactivities owing to immunodepressive therapy of HIV infection or other reasons, decrease in antibody formation in response to vaccination can take place. Limited data indicate that with a sickemia Prevenar causes a sufficient immune response with a safety profile which does not differ from the children who are not entering into group of the increased risk in babies. Yet children have no data on safety and an immunogenicity of a vaccine from other groups of high risk on invasive pneumococcal diseases (for example, children with the hereditary or acquired spleen dysfunction, HIV infection, malignant new growths, a nephrotic syndrome). The decision on performing vaccination of children from groups of high risk should be made individually. To children from groups of high risk aged up to 2 years   vaccination is carried out according to the scheme of purpose of a vaccine Prevenar. When to children at the age of 24 months is also more senior, entering into group of high risk (for example, at a sickemia, an aspleniya, HIV infection, chronic diseases with immune dysfunction), initially vaccinated by Prevenar, the 23-valent pneumococcal polisakharidny vaccine is shown, it is necessary to enter it with an interval not less, than 8 weeks between vaccination. Preventive purpose of antipyretics is recommended to all children receiving Prevenar together with tselnokletochny pertussoid vaccines in view of higher risk of development of febrile reactions; and also to children with convulsive frustration, including "febrile" spasms in the anamnesis.

Side effects:

Prevenar's safety was studied  at healthy children aged from 6 weeks up to 18 months. In all cases Prevenar was applied along with drugimirekomendovanny children's vaccines. The most frequent undesirable reactions were morbidity in the place of an injection and fever (temperature increase). At a revaccination cases of quickly passing morbidity in the place of an injection (36,5%), and also cases of short-term restriction of volume of movements of an extremity because of morbidity in the place of an injection (18,5%) were most often observed. At the children of advanced age who received a vaccine once higher frequency of local reactions, than at children up to 1,5 years was observed, but these reactions were short. As well as at introduction of other vaccines, at primary immunization by Prevenar, it is necessary to consider possible risk of an apnoea at children aged up to 28 weeks, and especially at children with immaturity of a respiratory organs in the anamnesis. Reactogenicity was higher at children to whom together with Prevenar appointed tselnokletochny antipertussoid vaccines (KDS). Temperature from 38 °C and was observed at 41,2% of children above, and it is above 39 °C - at 3,3% of children, in comparison with 1,2% of children which appointed only KDS. Similar  increase in frequency of cases of high temperature was observed at combined use of Prevenar with the hexavalent vaccines used in pediatrics (against whooping cough, tetanus, diphtheria, a hemophilic infection of type B, poliomyelitis and hepatitis B). The undesirable reactions given below were reported during clinical trials and the address of drug in the market, and are classified by bodies and systems, and also according to emergence frequency in all age groups. Frequency of reactions was defined as follows: Very frequent: ≥1/10; frequent: ≥1/100 and

Interaction with other medicines:

Prevenar children can enter at the same time (in one day) with other vaccines included in the National calendar of preventive inoculations (except for BTsZh), and also with a vaccine against  Hemophilus influenzae  type b (Хиб) and a hexavalent vaccine of Infanriks, according to the ordered scheme of immunization. It is necessary to enter vaccines always into different body parts. Prevenar is delivered in the syringe, already ready to use, which contents it is not necessary to transfer to other capacity and to mix with other medicines.

Contraindications:

Hypersensitivity at the previous Prevenar's introduction, hypersensitivity to excipients and/or a diphtherial anatoxin; acute infectious and noninfectious diseases, an exacerbation of chronic diseases (in these cases vaccination is carried out after recovery or to remission stages).

Overdose:

It is described several cases of overdose of Prevenar, and also introduction of the subsequent dose before the ordered terms. The undesirable reactions observed at overdose corresponded to that when using of the recommended single doses of Prevenar.

Storage conditions:

At a temperature from 2 to 8 °C. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 0,5 ml of drug in the one-time syringes from transparent colourless borosilicate glass (type I) with a capacity of 1 ml supplied with the adapter from transparent polycarbonate and a gray butylrubber cap for a syringe tip cone, the piston (with a gray butylrubber sealant) with the piston stroke limiter from transparent or blue polypropylene. On 1 syringe complete with a syringe needle from stainless steel in an individual cover or on 5 syringes place in plastic packaging and seal a polyethylene film. On 1 plastic packaging (1 syringe complete with a syringe needle from stainless steel in an individual cover) or on 2 plastic packagings (5 syringes) complete with 10 syringe needles from stainless steel in individual covers in strips (2 strips on 5 needles) together with the application instruction place in a cardboard pack.