Instruction for use: Ultrix

Dosage form: Solution for intramuscular injection

Active substance: Vaccinum ad prophylaxim grippi inactivatum

ATX

J07BB01 Influenza virus inactivated whole

Pharmacological group

MIBP vaccines [Vaccines, sera, phages and toxoids]

The nosological classification (ICD-10)

J10 Influenza caused by an identified influenza virus: Influenza A; Influenza B; Influenza A type; Influenza A of type B

Z25.1 The need for immunization against influenza

Composition

Solution for intramuscular administration 1 dose (0.5 ml)

Influenza viruses cultured on chick embryos, inactivated, digested, represented by strains:

A (H1N1) (15 ± 2,2) μg hemagglutinin

A (H3N2) (15 ± 2,2) μg hemagglutinin

B (15 ± 2,2) μg hemagglutinin

Auxiliary substance: preservative (merthiolate) - 42,5-57,5 mkg or does not contain preservative

The antigenic composition of the vaccine changes every year in accordance with the epidemic situation and WHO recommendations.

Description of dosage form

Solution: opalescent colorless liquid.

Characteristic

The vaccine is a mixture of highly purified protective surface and internal antigens of influenza viruses type A (H1N1 and H3N2) and type B.

Pharmachologic effect

Mode of action - Immunostimulating.

Pharmacological (immunobiological) properties

The vaccine forms a high specific immunity against influenza A and B, is well tolerated by adults. After vaccination, antibodies appear after 8-12 days, immunity persists to 12 months. High efficiency of the vaccine is provided by the presence in it of both surface and internal antigens of the influenza virus.

Indications for the Ultrix

Prevention of influenza. Vaccination is recommended for the following groups of people:

Children from 6 years;

Students of higher and secondary vocational schools;

Working adults, especially employees of medical and educational institutions, transport, communal sphere;

Persons suffering from chronic physical illness;

Persons who are often ill with acute respiratory diseases;

Adults over 60 years.

Contraindications

Allergic reactions to previous vaccinations with influenza vaccines;

Allergic reactions to chicken protein and vaccine components;

Acute febrile conditions or exacerbation of a chronic disease;

The period of breastfeeding.

Application of pregnancy and breastfeeding

No information is available. Clinical studies have not been conducted.

Side effects

The introduction of the vaccine may be accompanied by local and general reactions.

Very rarely - at the injection site there may be reactions in the form of soreness, redness and swelling of the skin.

It is extremely rare - in individuals, general reactions are possible in the form of increased fatigue, headache, dizziness, subfebrile temperature, runny nose, pharyngitis, coughing, arthralgia, myalgia, nausea. These reactions usually disappear on their own in 1-3 days.

In extremely rare cases - with high individual sensitivity allergic reactions can be observed.

Interaction

The vaccine can be used concomitantly with other inactivated vaccines. This should take into account contraindications to each of the vaccines used, the drugs must be injected into different parts of the body with different syringes. Vaccination of patients receiving immunosuppressive therapy may be less effective.

Dosing and Administration

IM, in the deltoid muscle.

The vaccine is given once in a dose of 0.5 ml.

With mild ARVI, acute intestinal diseases, vaccination is carried out after the temperature is normalized. Vaccinations are carried out after recovery (remission).

On the day of vaccination, the vaccinated should be examined by a physician / paramedic with mandatory thermometry. At a temperature above 37 ° C vaccination is not carried out.

The preparation is not suitable for use in ampoules or syringes with broken integrity or marking, with changing physical properties (chromaticity, transparency), expired shelf life, violation of requirements for storage conditions.

Ampoules

Before use, the vaccine should be allowed to reach room temperature and shaken well.

The vials are opened and the vaccination procedure is carried out with strict adherence to the rules of aseptic and antiseptic: before opening the ampoule, the neck of the ampoule is wiped with cotton wool soaked with 70% ethyl alcohol, the ampoule is opened, the vaccine is taken into a disposable syringe and the remainder of the air is removed from the syringe. Alcohol rubs the skin at the injection site. The drug in the opened ampoule is not subject to storage.

Syringes

Shake the syringe immediately before injection. Remove the protective cap from the needle and remove air from the syringe by holding it upright with a needle and slowly pressing the piston.

Special instructions

Do not enter iv.

In the offices where the vaccination is carried out, it is necessary to have medicines for carrying out anti-shock measures and stopping the anaphylactic reaction.

The vaccinated should be monitored by a health worker within 30 minutes after immunization.

Influence on the ability to drive vehicles and work with machinery. No information is available.

Release form

Solution for intramuscular injection. In ampoules. 10 amp. In a pack of cardboard or in a contour acheive box in a pack of cardboard with a knife ampoule or scarifier. When packing ampoules with a vestigial having a ring or an opening point, the ampoule knife or scarifier does not insert.

In sterile syringe single-use syringes with a sterile single-use injection needle, with a protective cap, 0.5 ml (1 dose) in a pack of cardboard.

1 sterile syringe with a single use with a sterile injectable needle for single use, with a protective cap, in a pack of cardboard.

On the pack of the drug, which does not contain a preservative, there is a warning inscription "No preservative".

Manufacturer

1. FSUE SPbNIIVS FMBA of Russia. 198320, St. Petersburg

2. Branch of the Federal State Institution "48 Central Scientific Research Institute of the Ministry of Defense of the Russian Federation" - "Virology Center". 141306, Russia

The owner of the registration certificate: OOO "FORT". 390000, Russia

Complaints on the quality of the drug, as well as information on cases of increased reactogenicity or the development of complications, should be sent to the Federal Service for Supervision in Health and Social Development (Roszdravnadzor) and to OOO Fort, indicating the number of the drug series and the release date, followed by medical presentation Documentation.

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Ultrix

At a temperature of 2-8 ° C (do not freeze). In accordance with JV 3.3.2.1248-03.

Keep out of the reach of children.

The shelf life of the drug Ultrix

1 year.

Do not use beyond the expiration date printed on the package.