Sinflorix Vaccines (pneumococcal polysaccharide) suspension

$129.00

Active immunization of infants and children aged 6 weeks to 5 years for the prevention of pneumococcal infection caused by serotypes of Streptococcus pneumoniae 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive serotype 19A (including sepsis , meningitis, pneumonia, bacteremia and acute otitis media), as well as acute otitis media caused by atypical Haemophilus influenzae.

Category: Manufacturer: Belgium

Description

Product form, packaging and composition
Suspension for intravenous administration of white color, which separates when settling into two layers: a colorless supernatant and a white precipitate, which is completely broken by shaking without flakes and conglomerates.
1 dose
vaccine for the prevention of pneumococcal infections 0.5 ml
Streptococcus pneumoniae polysaccharides conjugated to carrier proteins:

  • Serotype polysaccharide 1 1 μg / PD;
  • Serotype polysaccharide 4 3 μg / PD;
  • Serotype polysaccharide 5 1 μg / PD;
  • Serotype 6B polysaccharide 1 μg / PD;
  • Polysaccharide serotype 7F 1 μg / PD;
  • Polysaccharide serotype 9V 1 μg / PD;
  • Serotype 14 polysaccharide 1 μg / PD;
  • Polysaccharide serotype 18C 3 μg / PD;
  • Polysaccharide serotype 19F 3 μg / PD;
  • Polysaccharide serotype 23F 1 μg / PD.

Carrier proteins (total amount):
PD: Haemophilus influenzae D-protein 9-16 mcg *
TT: tetanus toxoid 5-10 mcg *
DT: diphtheria toxoid 3-6 mcg *
* the composition of the drug is based on the content of polysaccharides, and the individual content of the carrier protein depends on the ratio of “polysaccharide / protein”
Excipients: aluminum phosphate (in terms of aluminum) 0.5 mg, sodium chloride 4.4 mg, water d / i up to 0.5 ml.
Pharmacological action
The vaccine contains antigens of 10 serotypes of Streptococcus pneumoniae (1, 4, 5, 6B, 7F, 14, 18C, 19F and 23F), which cause the highest number of cases of invasive pneumococcal infection (50-96%) and pneumonia in children under 5 years of age in the world.
Also in 60-70% of clinical cases, acute otitis media (OCT) has a bacterial cause and is most often caused by Streptococcus pneumoniae and untyped Haemophilus influenzae.
Indications 
active immunization of children aged 6 weeks to 5 years to prevent 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.

Application during pregnancy and lactation
Since Synflorix vaccine is not intended for use in adults, no studies have been conducted on the use of the vaccine during pregnancy or lactation.
Dosing mode
Method of administration
The vaccine should only be administered intramuscularly!
It is forbidden to administer the vaccine intravascularly or intradermally.
There are no data on subcutaneous administration of Synflorix vaccine.
Recommended injection sites are the anterolateral thigh surface in children of the first year of life or the deltoid muscle of the shoulder in children older than 1 year.
During storage, the vaccine is divided into a white precipitate and a clear supernatant, which is not an indicator of deterioration of the drug.
Shake the vaccine well before use to form a homogeneous suspension!
Do not use if the contents of the syringe or vial of Synflorix vaccine look different than in the “Description” section of this leaflet.
Unused drug and waste from its use must be disposed of in accordance with the requirements adopted in the Russian Federation.
Vaccination schemes
A single dose of the vaccine is 0.5 ml.
Children aged 6 weeks to 6 months (inclusive)
Primary immunization with 3 doses of vaccine
The recommended immunization schedule, which provides the optimal level of protection, consists of 3 vaccinations followed by revaccination. The optimal age (the beginning of vaccination – 2 months of life, and subsequent vaccinations – with an interval of at least 1 month between them. It is possible to start vaccination earlier, but not earlier than 6 weeks of life.
Revaccination is recommended no earlier than 6 months after the last vaccination of the primary vaccination course, preferably at the age of 12-15 months.
Primary immunization with 2 doses of vaccine
In the event that Sinflorix is ​​administered as part of a mass immunization, the vaccination schedule may consist of 2 vaccinations followed by revaccination. The first vaccination is given from 2 months of age, and the second – 2 months after the first. The revaccination dose is recommended not earlier than 6 months from the date of the last vaccination.
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 performed from 2 months of age, and subsequent – with an interval of at least 1 month between them.
It is recommended to administer the revaccination 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 aged 7-11 months
The immunization schedule consists of two vaccinations with an interval of at least 1 month between doses.
The revaccination dose is recommended to be administered in the second year of life not earlier than 2 months from the date of the last vaccination.
Children aged 12-23 months
The vaccination schedule consists of two vaccinations with an interval of at least 2 months between doses.
The need for a revaccination dose in this scheme 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 the vaccination was started with the Synflorix vaccine, it is recommended that the full course of vaccinations be given with the same vaccine.

Contraindication
Hypersensitivity to the active substances and excipients of the vaccine or any carrier protein.
As with other vaccines, the vaccine should be delayed in people with acute illnesses accompanied by fever. However, the presence of mild minor manifestations of infectious diseases, such as colds, is not a reason to postpone vaccination.

Side effect:

  • From the nervous system: drowsiness, febrile and afebrile seizures;
  • From the respiratory system, chest and mediastinal organs: apnea in very premature (≤28 weeks of gestation) children;
  • From the side of metabolism and nutrition: loss of appetite;
  • From the gastrointestinal tract: diarrhea, vomiting;
  • From the immune system: allergic reactions (such as allergic dermatitis, atopic dermatitis, eczema);
  • From the side of the psyche: irritability, pathological crying;
  • On the part of the skin and subcutaneous fat: rash, urticaria;
  • General and local reactions: pain, redness, swelling at the injection site, fever (rectally ≥ 38 ° C, age <2 years), induration at the injection site, fever (rectally> 39 ° C, age <2 years; ≥ 38 ° C , age 2-5 years), 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).

* noted during revaccination.
Storage conditions of the drug
Store at temperatures from 2 to 8 ° C in a dark place. Do not freeze. Keep out of reach of children.
Shelf life of the drug
The shelf life is 3 years.