Sinflorix vaccine for the prof. of pneumas.inf./not type .gemof.inf. susp. for infection. 1 dose syringe of 0.5 ml No. 1 ***

vaccine "Sinfloriks™" is applied to active immunization of newborns and children aged from 6 weeks up to 5 years for prevention of the pneumococcal infection caused by serotypes of Streptococcus pneumoniae 1, 4, 5, 6V, 7F, 9V, 14, 18C, 19F, 23F and a cross and reactive serotype 19A (including sepsis, meningitis, pneumonia, bacteremia and acute average otitis) and also the acute average otitis caused by atypical Haemophilus influenzae.

on the basis of official recommendations with risk of pneumococcal diseases at children of different age groups and also variability of epidemiological data in various geographical zones.

Structure

Active ingredients: one dose (0.5 ml) contains 1 mkg of pneumococcal polysaccharide of serotypes of 1 ^1.2 , 5 ^1.2 , 6B of ^1.2 , 7F of ^1.2 , 9V of ^1.2 , 14 ^1.2 , 23F of ^1.2 and on 3 mkg of pneumococcal polysaccharide of serotypes of 4 ^1.2 , 18C of ^1.3 and 19F of ^1.4 .

Excipients: sodium chloride, water for injections.

¹ - adsorbed on aluminum phosphate - 0.5 mg of Al ³⁺ .

² - conjugated with the protein of D (received from a netipovany strain of Haemophilus influenzae) ~ 13 mkg.

³ - conjugated with a protein of tetanic anatoxin ~ 8 mkg.

⁴ - conjugated with a protein of a diphtherial anatoxin ~ 5 mkg.

Contraindication

• hypersensitivity to acting and to excipients of vaccine or any carrier protein;
by
• as well as at use of other vaccines, prescribing of the vaccine "Sinfloriks™" has to be postponed at persons with the acute diseases which are followed by fever; however, existence of easy insignificant manifestations of infectious diseases, such as cold, is not the basis for vaccination adjournment.

Route of administration

Vaccine is entered intramusculary. Preference is given to vaccine injection to the anterolateral area of a hip to babies or in a deltoid muscle of a hand to children of advanced age.

according to requirements of the existing orders MZ of Ukraine concerning schemes of immunization, contraindications and interaction with other medicines.

to the vaccine "Sinfloriks™" on the basis of official recommendations.

Babies aged from 6 weeks up to 6 months

Primary scheme of vaccination, including 3 doses. The recommended scheme of vaccination that provides optimum protection, includes 4 doses on 0.5 ml everyone. Primary scheme for babies includes 3 doses with an interval not less than 1 month between doses. The first dose can be entered at the age of 6 weeks. The fourth (booster) dose it is recommended not earlier than in 6 months after the 3rd dose and it can be applied since 9 months (it is desirable aged between 12 and 15 months).

Primary scheme of vaccination that includes two doses. Alternatively, in case of vaccine injection of "Sinfloriks™" within the standard program of immunization of babies, the scheme including 3 doses on 0.5 ml everyone can be applied. The first dose can be entered at the age of 6 weeks, the second dose is entered in 2 months. The booster dose is recommended not earlier than in 6 months after the last dose of primary scheme of vaccination and can be applied since 9 months.

Premature babies with the term of a gestation of at least 27 weeks. The recommended immunization series for ensuring optimum protection consists of 4 doses on 0.5 ml everyone. Primary scheme for babies consists of 3 doses, first of which month between doses is usually entered in 2 months, with an interval not less than 1. The booster dose at least in 6 months after the last dose of primary immunization is recommended.

≥ 7 monthly age:

• babies at the age of 7=11 months: the scheme of vaccination includes two doses on 0.5 ml with an interval not less than 1 month between doses; the third dose is recommended on the second year of life with an interval not less than 2 month between doses;
• children at the age of 12 months - 5 years: the scheme of vaccination includes two doses on 0.5 ml with an interval not less than 2 months between doses.

Feature of use

Pregnant

"Sinfloriks™" it is not intended for use by the adult.

Children

Safety and immunological efficacy of "Sinfloriks™" at children are more senior than 5 years are not established.

Overdose

Missile defense cases of overdose it was not reported.

Side effects

At newborns the most frequent side reactions after primary immunization were reddening in the injection site and irritability which were observed approximately at 41% and 55% of total number of vaccination. After introduction of a booster dose, pains in the place of an injection and irritability which were observed approximately at 51% and 53% respectively were the most frequent side reactions. The majority of these reactions were easy and moderate severity and continued not for long.

to Store

in original packing for protection against light at a temperature from 2 °C to 8 °C (in the fridge), out of children's reach. Not to freeze.

Expiration date - 4 years.

After opening of a multidose bottle, vaccine it is necessary to use at once.

If vaccine is not used at once, it needs to be stored in the fridge (at a temperature from 2 °C to 8 °C). If vaccine is not used within 6 hours, it needs to be utilized.