Composition, form of production and packaging
Suspension for the / m introduction of white, homogeneous; when settling, a precipitate forms, which easily breaks when shaken.
pneumococcal conjugates (polysaccharide + CRM 197 ) 1 dose
polysaccharide serotype 1 - 2.2 Ојg polysaccharide serotype 3 2.2 Ојg polysaccharide serotype 4 2.2 Ојg polysaccharide serotype 5 2.2 Ојg polysaccharide serotype 6A 2.2 Ојg polysaccharide serotype 6B 4.4 Ојg polysaccharide serotype 7F 2.2 Ојg polysaccharide serotype 9 V 2.2 Ојg polysaccharide serotype 14 - 2.2 Ојg oligosaccharide serotype 18C - 2.2 Ојg polysaccharide serotype 19A - 2.2 Ојg polysaccharide serotype 19F - 2.2 Ојg polysaccharide serotype 23F - 2.2 Ојg carrier protein CRM 197 ~ 32 Ојg
Excipients: aluminum phosphate 0.5 mg (in terms of aluminum 0.125 mg), sodium chloride 4.25 mg, succinic acid 0.295 mg, polysorbate 80 0.1 mg, water d / and up to 0.5 ml.
PREVENAR 13 is produced in accordance with WHO recommendations on the production and quality control of pneumococcal conjugate vaccines.
0.5 ml - syringes disposable colorless glass (1) with a capacity of 1 ml - plastic packaging (1) complete with injection needles (1 pc.) - packs of cardboard.
0.5 ml - disposable colorless glass syringes (5) with a capacity of 1 ml - plastic packaging (2) complete with injection needles (10 pcs.) - packs of cardboard.
0.5 ml - disposable colorless glass syringes (100) with a capacity of 1 ml unmarked - plastic containers.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Vaccine for the prevention of pneumococcal infections.
Introduction of the vaccine Prevenar 13 elicits the production of antibodies to the capsular polysaccharides of Streptococcus pneumoniae, thus providing specific protection against infection caused by the included 1,3,4, 5, 6A, 6B, 7F, 9V, 14,18C, 19A, 19F and 23Fserotypes included in the vaccine pneumococcus.
According to WHO recommendations for new conjugated anti-pneumococcal vaccines, the equivalence of the immune response was estimated using the Prevenar 13 and Prevenar vaccines in a set of three independent criteria: the percentage of patients who reached the concentration of specific IgG antibodies? 0.35 Ојg / ml; average geometric concentrations of immunoglobulins (IgG GMC) and opsonophagocytic activity of bactericidal antibodies (OFA titer? 1: 8). Introduction Prevenar 13 elicits an immune response to all 13 vaccine serotypes equivalent to the Prevenar vaccine as defined above.
The Prevenar 13 vaccine includes up to 90% of all serotypes that cause invasive pneumococcal infections (IPI), including antibiotic-resistant ones. Observations conducted in the USA since the introduction of the 7-valent conjugation vaccine Prevenar suggest that the most severe cases of invasive pneumonia are associated with the action of serotypes included in Prevenar 13 (1, 3, 7F and 19A), in particular, serotype 3 is directly related with the disease necrotizing pneumonia.
The immune response when using three or two doses in a series of primary vaccinations
After the introduction of three doses of Prevenar 13, a significant increase in the level of antibodies to all serotypes of the vaccine was noted in the primary vaccination of children up to 6 months of age. After the introduction of two doses in the initial vaccination of Prevenar 13, a significant increase in antibody titers to all components of the vaccine was also observed in the mass immunization of children of the same age group, but an IgG в‰Ґ 0.35 Ојg / ml for serotypes 6B and 23F was detected in a smaller percentage of children. At the same time, the concentration of antibodies after the administration of the booster dose of Prevenar 13 as compared with the concentration of antibodies before the administration of the revaccinating dose increased for all 13 serotypes. The formation of immunological memory is indicated for both of the above vaccination schemes. The secondary immune response to the revaccinating dose in children of the second year of life, using three or two doses in a series of primary vaccinations, is comparable for all 13 serotypes.
Prevenary 13 contains seven serotypes in common with the Prevenar vaccine and CRM197 carrier protein. The comparative identity of both vaccines in terms of immunogenicity and the safety profile makes it possible to switch from Prevenar to Prevenar 13 at any stage of a child's vaccination, and the additional 6 serotypes in Prevenar 13 provide greater protection from IPI.
- Prevention of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B; 7F, 9V, 14, 18C, 19A, 19F and 23F (including bacteremia, sepsis, meningitis, pneumonia and acute otitis media) in children aged 2 months to 5 years.
Mode of administration:
The vaccine is administered intramuscularly - in the anterolateral hip surface (children up to 2 years old) or in the deltoid muscle of the shoulder (children over 2 years old), in a single dose of 0.5 ml. Prior to use, the syringe with Prevenar 13 should be shaken well until a homogeneous suspension is obtained. Do not use if foreign particles are detected when inspecting the contents of the syringe, or the contents look different than in the "Description" section of this manual.
Do not administer Prevenar 13 intravenously!
Age from 2 to 6 months:
A series of triple primary vaccination: 3 doses of Prevenar 13 are administered with intervals between administrations of at least 1 month. The first dose can be administered to children from the age of 2 months. Revaccination is carried out once in 11-15 months. The scheme is used in the implementation of individual immunization of children against pneumococcal infection.
A series of double primary vaccination: 2 doses of Prevenar 13 are administered with an interval between administrations of at least 2 months. The first dose can be administered to children from the age of 2 months. Revaccination is carried out once in 11-15 months. The scheme is used in the implementation of mass immunization of children against pneumococcal infection.
For children to whom vaccination was not initiated in the first 6 months of life, the introduction of Prevenar 13 is carried out according to the following schemes:
Age from 7 to 11 months: two doses with an interval between injections of at least 1 month. Revaccination is carried out once in the second year of life.
Age 12-23 months: two doses with an interval between administrations of at least 2 months.
Age from 2 to 5 years (inclusive): once
If vaccination is initiated by Prevenar 13, it is recommended that it be completed with the Prevenar vaccine 13.
If there is a forced increase in the interval between injections of any of the above vaccination courses, the introduction of additional doses of Prevenar 13 is not required.
Children previously vaccinated by Prevenar
Vaccination against pneumococcal infection initiated by the 7-valent Prevenar vaccine may be continued with Prevenar 13 at any stage of the immunization schedule.
Safety of vaccine Prevenar 13 was studied in healthy children (4429 children / 14267 doses of vaccine) at the age of 6 weeks to 11-16 months. In all studies Prevenar 13 was used concomitantly with other vaccines recommended for this age.
In addition, the safety of the Prevenar 13 vaccine was evaluated in 354 children aged 7 months to 5 years who had not previously been vaccinated with any of the pneumococcal conjugate vaccines.
The most frequent adverse reactions were reactions at the injection site, fever, irritability, decreased appetite, and disturbed sleep.
In older children with primary vaccination Prevenar 13 there was a higher frequency of local reactions than in children of the first year of life.
The undesirable reactions listed below are classified according to the organs and systems, and also according to the frequency of their manifestation in all age groups.
The frequency of undesired reactions was determined as follows:
Very frequent (? 1/10), frequent (? 1/100, but <1/10), infrequent (? 1/1000, but <1/100), rare (? 1/10000, but <1/1000) and very rare (? 1/10000).
Undesirable reactions identified in clinical trials Prevenar 13
General and local reactions:
Very frequent: hyperthermia up to 39 В° C; irritability; hyperemia of the skin, soreness, constriction or edema of 2.5-7.0 cm at the injection site; drowsiness, worsening of sleep.
Frequent: hyperthermia is above 39 В° C; soreness at the injection site, leading to a short-term restriction of the limb movements.
Infrequent: skin hyperemia, densification or swelling larger than 7.0 cm at the injection site; tearfulness.
Rare: cases of hypotonic collapse, hypersensitivity reactions at the injection site (hives, dermatitis, pruritus) *; flushes of blood to the face.
Blood and lymphatic system:
Very rare: regional lymphadenopathy *.
The immune system:
Rare: a hypersensitivity reaction, including dyspnea, bronchospasm, angioedema of different localization; anaphylactic / anaphylactoid reaction, including shock.
Rare: convulsions (including febrile).
Very frequent: decreased appetite.
Infrequent: vomiting, diarrhea.
Skin and subcutaneous tissue:
Rare: rash, hives.
Very rare: erythema multiforme *.
* - were observed in post-marketing surveillance of Prevenar vaccine; can be considered as possible for Prevenar 13.
- hypersensitivity to the previous administration of Prevenar 13 or Prevenar (including anaphylactic shock, severe generalized allergic reactions);
- hypersensitivity to diphtheria toxoid and / or excipients;
- acute infectious or non-infectious diseases, exacerbations of chronic diseases. Vaccination is performed after recovery or during remission.
PREGNANCY AND LACTATION
Information is not applicable to the target category of Prevenar 13.
Given the rare cases of anaphylactic reactions, a child after vaccination should be under medical supervision for at least 30 minutes. Places of immunization should be provided with anti-shock therapy. When deciding whether to vaccinate a child with a severe degree of prematurity (pregnancy в‰Ґ28 weeks), especially having a history of immaturity of the respiratory system, it should be borne in mind that the benefit of immunization against pneumococcal infection in this group of patients is particularly high, and neither vaccination nor transfer should be postponed terms. However, in connection with the potential risk of apnea (available with any other vaccine), the first vaccination of Prevenar 13 should be performed in a hospital setting under medical supervision (at least 48 hours).
As with other intramuscular injections, children with thrombocytopenia and / or other disorders of the coagulating blood system and / or in case of treatment with apycoagulants, vaccination with Prevenar 13 should be carried out with caution, provided that the child's condition is stabilized and hemostasis is achieved.
Prevenar 13 provides protection only from those serotypes of Streptococcus pneumoniae that are included in its composition and does not protect against other microorganisms that cause invasive diseases, pneumonia or otitis media. In children with impaired immunosuraktivnosti vaccination may be accompanied by a lower level of antibody formation.
There is limited information that the predecessor Prevenar 13, the seven-valent Prevenar vaccine, elicits an adequate immune response in children under the age of 6 months with sickle cell anemia, and the Prevenar safety profile is similar to that of vaccines not belonging to high-risk groups . There are currently no data on the safety and immunogenicity of vaccines in children of other high-risk groups for invasive pneumococcal infections (eg, in children with congenital or acquired spleen dysfunctions, HIV infection, malignant tumors, nephrotic syndrome). The decision to vaccinate children from high-risk groups should be taken individually. The relevant data for the Prevenar 13 vaccine are currently not available.
Children from high-risk groups under the age of 2 years should be vaccinated against Prevenar 13 according to their age. In cases where children aged 2 years or older who are at high risk (for example, with sickle cell anemia, asplenia, HIV infection, chronic disease or immunological dysfunction) and previously given Vaccination Prevenar 13, a 23-year- valence pneumococcal polysaccharide vaccine, the interval between vaccines should be at least 8 weeks.
Due to the fact that the cause of the development of otitis media can be the most diverse pathogens (viruses, bacteria, fungi, mixed infections) - and not only pneumococci of the 13 serotypes entering Prevenar, the anticipated preventive efficacy of Prevenar 13 against otitis media may be less pronounced , compared with the efficacy for invasive diseases.
Due to the higher risk of febrile reactions to children with convulsive disorders, including those with a history of febrile convulsions, as well as those who receive Prevenar 13 concomitantly with whole-cell pertussis vaccines, a prophylactic appointment of antipyretic agents is recommended.
Impact on the ability to drive vehicles and manage mechanisms
Information on the effect of the drug on the ability to drive and use machinery is not applicable to the target category of patients.
Overdose Prevenar 13 is unlikely, since the vaccine is released in a syringe containing only one dose.
Data on the interchangeability of Prevenar and Prevenar 13 to non-CDM 197 -based pneumococcal conjugate vaccines are not available.
Preventor 13 is combined with any other vaccines included in the immunization schedule for children of the first years of life. Prevenar 13 can be administered to children simultaneously (on the same day) with any of the following antigens that are part of both monovalent and combination vaccines: diphtheria, tetanus, acellular or whole-cell pertussis, Haemophilus influenzae type b, inactivated polio, hepatitis B, measles, epidemic mumps, rubella and chicken pox - without changing the reactogenicity and immunological parameters.
With simultaneous vaccination Prevenar 13 and other vaccines, injections are made in different parts of the body.
TERMS OF RELEASE FROM PHARMACY
Packing with 1 syringe is a prescription vacation.
Packing with 10 syringes - leave for medical and preventive institutions.
TERMS AND CONDITIONS OF STORAGE
At a temperature of 2 to 8 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 3 years.