Influvac Tetra - instructions for use

Registration number:
P N 015694/01
Torgovoe naimenovanie preparations:
Inflyuvak® (influenza subunit vaccine inactivated)
Mejdunarodnoe nepatentovannoe naimenovanie:
flu vaccine prophylaxis [inactivated]
Medical form:
suspension dlya vnutrimыshechnogo i podkojnogo vvedeniya.
Composition:
The drug represents a three-component inactivated influenza vaccine, consisting of poverxnostnyx antigens (hemagglutinin (GA), neuraminidase *).
active substances:
In a single dose of vaccine (0.5 ml) contains hemagglutinin and neuraminidase following viral strains:

A (H3N2) ** 15 mkg GA
A (H1 N1) ** 15 mkg GA
V ** 15 mkg GA
* cultivated on chicken embryos zdorovyx chicken.
** posle nazvaniya tipa antigena vыnositsya nazvanie shtamma, rekomendovannogo Vsemirnoy organizatsii zdravooxraneniya (VOZ) na tekushchiy epidemicheskiy sezon grippa.
Antigenic composition of influenza vaccine is updated annually in response to the epidemic situation and recommendations of the World Health Organization (WHO).
Auxiliary substances: potassium chloride - 0.1 mg, potassium dihydrogen phosphate - 0.1 mg, sodium phosphate dihydrate - 0.67 mg, sodium chloride - 4.0 mg, calcium chloride dihydrate - 0.067 mg, magnesium chloride hexahydrate - 0.05 mg, water for injection up to 0.5 ml, sodium citrate <1.0 mg, STAV <15 mcg, sucrose <0.2 mg, formaldehyde <0.01 mg, polysorbate-80 -sledy.
Description:
Prozrachnaya bestsvetnaya jidkost.
Pharmacotherapeutic group:
MIBP vaccine
ATX code:
J07BB02
Pharmacological properties
Pharmacodynamics

As a rule, serologic protection is achieved in 2-3 weeks after the introduction of the drug. Dlitelnost postvaktsinalnogo immuniteta v otnoshenii gomologichnyx shtammov ili v otnoshenii shtammov, podobnyx vaktsinnym shtammam, izmenchiva, no, kak pravilo, sostavlyaet 6-12 mesyatsev.

Indications for use
Ejegodnaya sezonnaya prophylaxis of influenza in adults and children with 6 months of age, in particular in patients with increased risk of developing complications associated with influenza virus infection.
In the frequency, the vaccine is recommended to patients following the following categories:
litsa starshe 65 let vne zavisimosti ot sostoyaniya ix zdorovya;
patients with chronic diseases of the nervous system, including bronchial asthma;
patients with chronic diseases of the cardiovascular system;
patients with chronic renal failure;
patients with chronic metabolic disorders, including diabetes mellitus;
patsyentы s immunodefitsitnymi sostoyaniyami na fone zabolevaniy ili v svyazi s priemom immunodepressantov (naprimer, cytostatiki, cortikosteroidy) ili poluchayushchie luchevuyu terapiyu;
children and adolescents (from 6 months to 18 years), in the course of prolonged periods poluchayushchie preparations containing soderjashchie acetylsalicylic acid, and, sledovatelno, podverjennыe povыshennomu risk of developing syndrome Reya vsledstvie influenza infection.
Protivopokazaniya
Hyperchuvstvitelnost kakomu-libo component vaktsiny or k veshchestvam, kotoryye mogut soderjatsya in ostatochnyx kolichestvax: kurinomu belku (ovalbuminu), formaldehyde, STAV, polysorbate-80 and gentamicin.
Strong reaction (temperature above 40 ° C, edema and hyperemia in the area of ​​infiltration svыshe 8 cm in diameter) or complication of predыdushchee introduction of the drug.
Deti mladshe 6 mesyatsev (effectiveness and safety are not established).
Vaccination otkladыvaetsya do okonchaniya ostryx proyavleniy zabolevaniya i obostreniya chronicheskix zabolevaniy. When netyajyolyx ORVI, ostryx kishechnyx zabolevaniyax and dr. Vaccination is carried out immediately after normalization of temperature.
Application during pregnancy and in the period of breastfeeding
Pregnancy
Clinical studies of the safety and effectiveness of the vaccine Inflyuvak® with the participation of pregnant women have not been conducted. The vaccine can be used by pregnant women, starting with the 2nd trimester of pregnancy. Imeetsya bolshoe kolichestvo dannyx o bezopasnosti tolko v otnoshenii primeneniya vaktsiny vo vtorom i tretem trimester beremennosti, no ne v pervom. Informatsiya, kasayushchayasya primeneniya vaktsiny protiv flu, sobrannaya po vsemu miru, ne ukazыvaet na razvitie kakix-libo neblagopriyatnyx vozdeystviy na plod i mat, kotorye svyazanы s primeneniem vaktsiny.
Period of grudnogo vskarmlivaniya
The vaccine can be used during the period of breastfeeding.

Sposob application and dosage
Dose for adults: 0.5 ml, vaccine vvoditsya odnokratno.
Dose for children:
ot 6 mesyatsev do 3-x let: 0.25 ml, vaccine vvoditsya odnokratno;
from 3 to 18 years: 0.5 ml, vaccine vvoditsya odnokratno.
Detyam, ranee ne vaktsinirovannym protiv flu, sleduet povtorno vvesti vaktsinu s intervalom menee 4 nedel.
Sposob primeneniya.
Categorically zapreshchaetsya inject the drug intravenously.
Vaktsinu sleduet vvodit vnutrimыshechno ili gluboko podkojno.
Pered vvedeniem vaccine doljna nagretsya to room temperature. Vstryaxnut shprits i visually check on otsutstvie inorodnyx chastits neposredstvenno pered injection. Snyat zashchitnыy kolpachok s igly i udalit vozdux iz shpritsa, uderjivaya ego v vertikalnom polojenii igloy vverx i medlenno najimaya na porshen.
Dose 0.25 ml (children from 6 months