Description
Release form
Suspension for intramuscular administration
Packaging
1 syringe 0.5 ml.
Indications
Active immunization of children aged 6 weeks to 5 years with the goal of preventing invasive diseases (including sepsis, meningitis, pneumonia, bacteremia) and acute otitis media caused by serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 1.9F and 23F Streptococcus pneumoniae.
Contraindications
– hypersensitivity to any component of the
vaccine – acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccinations. Vaccinations are carried out 2-4 weeks after recovery or during convalescence or remission. In mild ARVI, acute intestinal diseases and other vaccinations are carried out immediately after normalization of temperature. In the presence of mild symptoms of a cold, vaccination should not be delayed.
Use during pregnancy and lactation
Since the Sinflorix vaccine is not intended for use in adults, studies have not been conducted on the use of the vaccine during pregnancy or during lactation.
Special instructions
Prior to vaccination, a history must be ascertained, paying particular attention to previous vaccinations and the occurrence of possible adverse events.
Given the possibility of an extremely rare development of anaphylactic reactions, the patient should be under medical supervision for at least 30 minutes, and the vaccination sites should be provided with anti-shock therapy.
During or before vaccination, fainting may occur as a psychogenic response by the patient to an injection. In order to avoid injuries, the possibility of fainting should be considered when choosing an injection site.
As with other intramuscular vaccines, Sinflorix should be used with caution in patients with thrombocytopenia or other blood clotting disorders due to the risk of bleeding with intramuscular administration.
Sinflorix does not provide prophylaxis for diseases caused by pneumococci of other serogroups whose antigens are not part of this vaccine. Although an immune response to diphtheria toxoid, tetanus toxoid, and Haemophilus influenzae D protein is observed after administration of the Sinflorix vaccine, immunization with the Sinflorix vaccine does not replace routine immunization against diphtheria, tetanus, or Haemophilus influenzae type b. The official immunization requirements for these infections must be followed.
As with any other vaccination, not all Sinflorix vaccine vaccine can show a protective immune response.
In children with reduced immune status, possibly due to immunosuppressive therapy, a genetic defect, HIV infection, or other causes, a decreased level of antibody production after immunization may be observed.
Currently, there are no data on the safety and immunogenicity of the Sinflorix vaccine in children with an increased risk of pneumococcal infections (sickle cell anemia, congenital and acquired dysfunctions of the spleen, HIV infection, malignant neoplasms, and nephrotic syndrome).
The decision to vaccinate must be taken on an individual basis and be advised that in children 12-23 months of age, the two-dose vaccination schedule may not be sufficient to provide protection, and revaccination may be recommended. However, for children with an increased risk of pneumococcal infection (e.g. with sickle cell anemia, asplenia (absence of the spleen), HIV infection, chronic diseases or immune disorders) under the age of 2 years, it is recommended that the Sinflorix vaccine be immunized in accordance with age recommendations for 2 years of age and older can be used 23-valent pneumococcal polysaccharide vaccine (the minimum interval after the introduction of the Sinflorix vaccine is 8 weeks).
The potential risk of apnea and the need to monitor respiratory function for 48-72 hours should be considered with the primary vaccination of children born prematurely ( 28 weeks of gestation) and, especially, children with respiratory distress syndrome. In view of the need to vaccinate children in this group, primary vaccination should not be delayed or refused.
The prophylactic use of antipyretic drugs before or immediately after vaccine administration can reduce the frequency and intensity of post-vaccine febrile reactions and can be recommended for children receiving Synflorix simultaneously with whole-cell pertussis vaccine, as well as for children with a history of febrile reactions. Additional information on the combined use with paracetamol is presented in the section ² ÑInteraction with other medicinal products ² Ñ.
The efficacy and safety of the Sinflorix vaccine in children older than 5 years has not been investigated.
Composition
1 dose contains: vaccine for the prevention of pneumococcal infections 0.5 ml
Streptococcus pneumoniae polysaccharides conjugated to carrier proteins: Serotype 1 polysaccharide 1 ?g /
PD Serotype 4 polysaccharide 4 ?g / PD
Serotype 5 polysaccharide 1 ?g / srdlk PD Serotype 6B polysaccharide 1 ?g / srdlk PD 1 Serotype 7F serotype polysaccharide 1 ?g / PD srdlcp 14 1 ?g / PD
Polysaccharide serotype 18C 3 ?g / PD
Polysaccharide serotype 19F 3 ?g / PD
Polysaccharide serotype 23F 1 ?g / PD
Carrier proteins (total): PD: D protein Haemophilus influenzae * 9-16-16
TT: tetanus toxoid 5-10 mcg *
DT: diphtheria toxoid 3-6 mcg *
* the composition of the drug is based on the polysaccharide content, and the individual Flax protein content of the carrier is dependent on the ratio of polysaccharide / protein
Dosage and administration of
A single dose of the vaccine is 0.5 ml.
Children 6 to 6 months of age (inclusive)
Primary immunization with 3 doses of the
vaccine Recommended immunization regimen that provides the optimal level of protection, consists of 3 vaccinations followed by revaccination. The optimal age (vaccination start is 2 months of life, and subsequent vaccinations with an interval of at least 1 month between them. An earlier start of vaccination is possible, but not earlier than 6 weeks of life.
It is recommended that vaccination be performed no earlier than 6 months after the last vaccination of the initial vaccination course, preferably aged 12-15 months
Primary immunization with 2 doses of the
vaccine When Sinflorix is given as part of a mass immunization, the vaccination schedule may consist of 2 vaccinations followed by re . Aktsinatsiey first vaccination is carried out 2 months of life, and the second – 2 months after the first dose of a booster is recommended to be administered not earlier than 6 months after the last vaccination date
Children.. born prematurely (at least 27 weeks of gestation)
The recommended immunization schedule consists of 3 vaccinations followed by revaccination. The first vaccination can be carried out from 2 months of life, and subsequent ones with an interval of at least 1 month between them.
It is recommended to administer a booster dose no earlier than 6 months from the date of the last vaccination.
Children who have not been vaccinated during the first 6 months of life
Children 7-11 months of age
The immunization schedule consists of two vaccinations with an interval of at least 1 month between doses.
It is recommended to administer the revaccinating dose in the second year of life no earlier than 2 months from the date of the last vaccination.
Children 12-23 months of age
The vaccination schedule consists of two vaccinations with an interval of at least 2 months between doses.
The need for a booster dose in this regimen has not been established.
Children aged 24 months to 5 years
The vaccination schedule consists of two vaccinations with an interval of at least 2 months between doses.
If vaccination was started with the Sinflorix vaccine, then the full course of vaccinations is recommended to be given the same vaccine.
Side effects of
In clinical trials, approximately 12800 doses of Sinflorix vaccine were used for primary immunization of approximately 4,500 healthy babies and 137 babies born prematurely. About 3,800 healthy children and 116 premature babies were revaccinated with the Sinflorix vaccine in their second year of life. Safety of use is also confirmed by data, obtained in approximately 200 children aged 2 to 5 years. In all studies, Sinflorix was administered simultaneously with other recommended vaccines for a given age. No increase in the frequency or severity of adverse events was noted with each subsequent vaccination in a series of primary vaccinations.
It has been observed that the incidence of local reactions during the course of primary immunization is higher in children over 12 months of age compared with young children.
There was a higher reactogenicity in children with the simultaneous use of whole-cell pertussis vaccines.
The most frequent, however, mostly fast-passing, adverse events were redness at the injection site and irritability, the frequency of which reached 38.3% and 52.3%, respectively. At the stage of revaccination, the frequency of these phenomena slightly increased compared with the initial series of vaccinations and reached, respectively, 52.6% and 55.4%.
Adverse events listed below are listed by body system and according to frequency of occurrence for all age groups.
Frequency of occurrence is defined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1/1 000). On the part of the nervous system Very often: drowsiness Rarely: febrile and afebrile seizures On the part of the respiratory system, chest and mediastinal organs Infrequently: apnea in very premature (? 28 weeks of gestation) children (see section Special instructions ) On the part of metabolism and nutrition Very often: loss of appetite From the gastrointestinal tract Infrequently: diarrhea, vomiting From the immune system Rarely: allergic reactions (such as allergic dermatitis, atopic dermatitis, eczema) Mentally Very often: mild irritability Skin and subcutaneous fat Rarely: rash, urticaria General and local reactions Very common: pain, redness, swelling at the injection site, fever (rectally? 38 ° C, age <2 years) Often: tightening in places e injections, fever (rectally> 39 ° C, age <2 years? 38 ° C, age 2-5 years) Infrequently: hematoma at the injection site, hemorrhage and induration at the injection site, fever (rectally> 40 ° C *, age <2 years> 39 ° C, age 2-5 years)
* was noted with booster vaccination.
Drug Interactions
Do not mix the vaccine with other drugs in the same syringe!
Use with other
vaccines Sinflorix vaccine can be given simultaneously with any of the following monovalent or combination vaccines (including combination vaccines (AaKDS-GepV-IPV / Khib and ATSKDS-GepV / Khib): diphtheria-tetanus acellular pertussis vaccine (AKaDS) diphtheria-tetanus whole-cell pertussis vaccine (DTPA), vaccine for the prevention of infection caused by Haemophilus influenzae type b (Hib), hepatitis B vaccine, inactivated polio prevention vaccine (IPV), measles, mumps and rubella vaccine, chickenpox vaccine, conjugated meningococcal serogroup C vaccine (CRM197 and TT conjugates), oral poliomyelitis vaccine (OPV), rotavirus vaccine.
Injections with different vaccines should always be done in different parts of the body!
The immune response and safety profile of co-administered vaccines remain unchanged, with the exception of the immune response to an inactivated polio vaccine (inactivated polio virus type 2), for which conflicting results were observed (seroprotection values ranged from 78% to 100%) . The clinical significance of this phenomenon is not known. The type of carrier protein (CRM197 or TT) in the meningococcal conjugate vaccines did not have any negative effect when used together.
Enhanced immune response to the capsular polysaccharide Haemophilus influenzae type b conjugated to tetanus toxoid, as well as diphtheria and tetanus antigens.
Use with systemic immunosuppressive drugs
In patients receiving immunosuppressive therapy, Sinflorix (like other vaccines in a similar case) may not elicit an adequate immune response.
Use with antipyretic agents
The prophylactic use of paracetamol as an antipyretic may reduce the immune response to pneumococcal vaccines. The clinical significance of this observation remains unknown.
Storage Conditions
Store at 2 to 8 ° C in a dark place. Do not freeze.
Expiration
3 years.
Terms leave through pharmacies
In retseptu
Dosage form
suspension for injection
GlaxoSmithKline, Great
