Sinflorix Vaccines (pneumococcal polysaccharide) suspension for injection 1 dose of 0.5 ml №1 in a pre-filled disposable syringe

Description

Sinflorix Vaccines (pneumococcal polysaccharide) suspension for injection 1 dose of 0.5 ml №1 in a pre-filled disposable syringe

Composition

active substances: one dose (0.5 ml) contains: 1 mcg of pneumococcal polysaccharide serotypes 1^1,2, 5^1,2, 6B^1,2, 7F^1,2, 9V^1,2, 14^1,2, 23F^1,2 and 3 mcg pneumococcal polysaccharide serotypes 4^1,2, 18C^1,3 and 19F^1,4;

• 1 adsorbed on aluminum phosphate – 0.5 mg of Al³⁺;
• 2 conjugated to protein D (derived from atypical strain of Haemophilus influenzae) ~ 13 mcg;
• 3 conjugated to tetanus toxoid protein 88 mcg;
• 4 conjugated to diphtheria toxoid protein 55 mcg.

Excipients: sodium chloride, water for injections.

Dosage form

Suspension for injection.

Main physical and chemical properties: turbid liquid after shaking. Colorless supernatant and white precipitate after precipitation.

Pharmacotherapeutic group

Bacterial vaccines. Vaccine for the prevention of pneumococcal infection. Pneumococcal purified polysaccharide antigen and Haemophilus influenzae, conjugated.
ATX code J07AL52.

Pharmacological properties

The 10 pneumococcal serotypes included in this vaccine are the major pathogenic serotypes in Europe, covering approximately 56-90% of invasive pneumococcal infections (IPIs) in children <5 years of age. In this age group, serotypes 1, 5 and 7F are the cause of 3.3 – 24.1% of IPIs, depending on the country and the study period.

Pneumonia of various etiologies is the leading cause of child morbidity and mortality worldwide. In prospective studies, it was found that Streptococcus pneumoniae in 30-50% was a probable cause of pneumonia.

Acute otitis media (AOM) is a common childhood disease of various etiologies. Bacteria can cause 60-70% of clinical episodes of AOM. Streptococcus pneumoniae and an atypical strain of Haemophilus influenzae (NTHi) are the most common causes of bacterial AOM worldwide.

Indication

Active immunization of infants and children aged 6 weeks to 5 years for the prevention of pneumococcal infection caused by 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.

The use of Sinflorix should be determined on the basis of official recommendations, taking into account the risk of pneumococcal disease in children of different ages, as well as the variability of epidemiological data in different geographical areas.

Contraindication

Hypersensitivity to the active substances and excipients of the vaccine or to any carrier protein.

As with other vaccines, Sinflorix should be delayed in persons with acute febrile illness. However, the presence of mild minor manifestations of infectious diseases, such as the common cold, is not a reason to delay vaccination.

Use during pregnancy or breastfeeding

Sinflorix is not intended for use in adults. There are no data on use during pregnancy or breastfeeding and reproductive studies in animals.

Method of application and dosage

The vaccine is given intramuscularly. Preference is given to the vaccine in the anterolateral thigh of infants or in the deltoid muscle of the arm in older children.

Vaccination of children on the territory of Ukraine is carried out in accordance with the requirements of the current orders of the Ministry of Health of Ukraine on immunization schemes, contraindications and interaction with other drugs.

Dosage

The immunization schedules provided for Sinflorix should be used based on official recommendations.

Infants aged 6 weeks to 6 months:

• Primary vaccination schedule, including 3 doses
  The recommended vaccination schedule, which provides optimal protection, includes 4 doses of 0.5 ml each. The primary regimen for infants includes 3 doses with an interval of at least 1 month between doses. The first dose can be administered at the age of 6 weeks. The 4th (booster) dose is recommended no earlier than 6 months after the 3rd dose and can be used from 9 months (preferably between 12 and 15 months).
• Primary vaccination schedule, including 2 doses
  Alternatively, if Sinflorix is administered as part of a standard infant immunization program, a regimen comprising 3 doses of 0.5 ml each may be used. The 1st dose can be administered at the age of 6 weeks, the 2nd dose is administered after 2 months. A booster dose is recommended no earlier than 6 months after the last dose of the primary vaccination schedule and can be used from 9 months.
• Premature infants with a gestational age of at least 27 weeks
  The recommended series of immunizations to ensure optimal protection consists of 4 doses of 0.5 ml each. The primary regimen for infants consists of 3 doses, the first of which is usually administered at 2 months, with an interval of at least 1 month between doses. A booster dose is recommended at least 6 months after the last dose of primary vaccination.

Previously unvaccinated infants older than ≥ 7 months of age:

• infants aged 7 – 11 months: the vaccination schedule includes 2 doses of 0.5 ml with an interval of at least 1 month between doses. The third dose is recommended in the second year of life with an interval of at least 2 months between doses.
• children aged 12 months – 5 years: the vaccination schedule includes 2 doses of 0.5 ml with an interval of at least 2 months between doses.

Children

The safety and efficacy of Sinflorix in children over 5 years of age have not been established.

Overdose

No cases of overdose have been reported.

Side effects

In infants, the most common adverse reactions after primary vaccination were redness at the injection site and irritability, which occurred in approximately 41% and 55% of all vaccinations. After the booster dose, the most common adverse reactions were injection site pain and irritability, which occurred in approximately 51% and 53%, respectively. Most of these reactions were mild to moderate in duration and short-lived.