Ultrix^® (Solution) Instructions for Use

Marketing Authorization Holder

Fort, LLC (Russia)

Manufactured By

Fort, LLC (Russia)

Or

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

ATC Code

J07BB02 (Influenza virus inactivated split or surface antigen)

Active Substance

Influenza vaccine (split virion), inactivated

Influenza vaccine (split virion), inactivated (BP British Pharmacopoeia)

Dosage Form

Ultrix®

Solution for intramuscular administration 0.5 ml/1 dose: syringes 0.5 ml 1 or 10 pcs., fl. 0.5 ml 1 or 10 pcs.; fl. 2.5 ml 1 pc.

Dosage Form, Packaging, and Composition

* – the type name is indicated after the strain name; the strain composition is brought into line with WHO recommendations for the current influenza epidemic season.

** – hemagglutinin.

0.5 ml – ampoules (10) – carton packs.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

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

The vaccine is well tolerated by adults and induces high specific immunity against influenza types A and B.

Immunity after vaccination persists for up to 12 months.

The high efficacy of the vaccine is ensured by the presence of both surface and internal antigens of the influenza virus.

Indications

• Specific prophylaxis of influenza in humans.

Annual vaccination is recommended for individuals at high risk of complications and for individuals who, by the nature of their profession, are at high risk of contracting influenza or infecting others

• Persons suffering from chronic somatic diseases;
• Persons frequently ill with acute respiratory infections;
• Healthcare workers;
• Service industry workers;
• Transport workers;
• Educational institution workers.

Approved for use from 12 years of age without an upper age limit.

ICD codes

Dosage Regimen

Vaccination is carried out annually in the autumn-winter period. Vaccination is also possible at the beginning of the epidemic rise in influenza incidence.

The vaccine is administered intramuscularly into the upper third of the outer surface of the upper arm (into the deltoid muscle).

Ampoule opening and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis: before opening, the ampoule knife and the ampoule neck are wiped with cotton wool moistened with 70% ethyl alcohol, the ampoule is opened, the vaccine is drawn into a single-use syringe and excess air is removed from the syringe.

The skin at the injection site is wiped with alcohol.

The drug in an opened ampoule must not be stored.

On the day of vaccination, individuals to be vaccinated must be examined by a doctor (paramedic) with mandatory thermometry. Vaccination is not carried out at a temperature above 37°C (98.6°F).

The drug in ampoules with damaged integrity or labeling, with changed physical properties (color, transparency), with an expired shelf life, or if storage requirements have been violated is not suitable for use.

Adverse Reactions

Local and systemic reactions to the vaccine administration are mostly absent. Rarely, reactions at the injection site in the form of soreness, redness, and swelling of the skin may occur. Some individuals may experience systemic reactions in the form of increased fatigue, headache, dizziness, subfebrile temperature, runny nose, pharyngitis, cough, arthralgia, myalgia, nausea. These reactions usually disappear on their own within 1-3 days. In extremely rare cases, allergic reactions may be observed in highly sensitive individuals.

Contraindications

• Allergic reactions to previous vaccinations, chicken protein, and vaccine components;
• Acute febrile conditions or exacerbation of a chronic disease.

For non-severe acute respiratory viral infections, acute intestinal diseases, vaccination is carried out after the temperature has normalized.

Vaccinations are carried out after recovery (remission).

Use in Pregnancy and Lactation

Clinical studies have not been conducted.

Pediatric Use

Approved for use from 12 years of age without an upper age limit.

Special Precautions

Do not administer intravenously. The rooms where vaccination is carried out must have medications for anti-shock measures and relief of an anaphylactic reaction.

The vaccinated person must be under the supervision of a healthcare professional for 30 minutes after immunization.

Drug Interactions

The vaccine can be administered against the background of basic therapy for the underlying disease. The vaccine can be used simultaneously with other inactivated vaccines. In this case, contraindications to each of the vaccines used must be taken into account, and the drugs must be administered into different parts of the body using different syringes.

Storage Conditions

Store and transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F) out of the reach of children. Do not freeze. Keep out of the reach of children.

Dispensing Status

Dispensed by prescription

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.