Influenza vaccine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INFLUENZA VACXIN

Composition:

One immunizing dose of vaccine (0.5 mL) contains:

Active substance:

inactivated split-virion strains of the following*:

A/Michigan/45/2015 (H1N1)pdm09-like virus 15 mcg;
A/Hong Kong/4801/2014 (H3N2)-like virus 15 mcg;
B/Brisbane/60/2008-like virus 15 mcg;

Excipients: disodium hydrogen phosphate (Na2HPO4), sodium dihydrogen phosphate (NaH2PO4), sodium chloride (NaCl).

*Influenza virus strains cultivated on embryonated eggs of healthy chickens.

The composition of the vaccine complies with the recommendations of the World Health Organization (WHO) for the Northern Hemisphere and the European Union decision for the 2017–2018 season.

Pharmaceutical form. Injection suspension.

Main physicochemical properties: slightly opalescent liquid.

Pharmacotherapeutic group. Viral vaccines. ATC code J07BB02.

Immunological and biological properties.

Pharmacodynamics.

Antibody immune response is generally achieved within 2–3 weeks. Duration of post-vaccination immunity varies, but usually lasts 6–12 months.

Phase III and Phase IV clinical studies were conducted to evaluate the efficacy of the medicinal product INFLUENZA VACXIN. After vaccination, three parameters were assessed: seroconversion factor for hemagglutinin antibody, protective level of hemagglutinin (HA) antibody, and geometric mean increase of antibody titer. Study results are presented in Table 1.

Table 1. Immunogenicity data obtained during clinical studies

INFLUENZA VACCI is produced from viruses cultivated in chicken embryos. The allantoic fluid containing the virus is harvested, inactivated, concentrated, and purified. The virus is then disrupted to obtain "split virus." Antibiotics are not used during the manufacturing process of INFLUENZA VACCI. The composition of viral antigens contained in INFLUENZA VACCI corresponds to WHO recommendations for the 2016–2017 season. The vaccine INFLUENZA VACCI induces antibody production and protects against clinical manifestations of the disease following vaccination. Since the influenza virus is subject to variation and its antigenic properties change significantly from time to time, protection provided by vaccination with INFLUENZA VACCI is limited to the strains included in the vaccine or closely related strains.

Effective immunity is achieved within 2–3 weeks after vaccination. The incubation period of influenza is several days; therefore, if infection occurred shortly before or immediately after vaccination, the disease may still develop. The vaccine does not protect against other respiratory infections that may present with symptoms similar to those of influenza.

To ensure adequate protection against influenza, vaccination should be repeated annually prior to the start of the epidemic season.

Clinical characteristics.

Indications.

Prevention of influenza caused by influenza viruses of subtypes A and B in adults and children aged 9 years and older.

Contraindications.

Prior to vaccination, a medical examination must be performed, including medical history taking, body temperature measurement, and examination of the skin, mucous membranes, conjunctiva of the eyes, and oral cavity, and, if necessary, clinical examination of the cardiovascular, respiratory, and gastrointestinal systems. Vaccination should not be administered if any of the following symptoms or conditions are present:

• hypersensitivity to vaccine components;
• hypersensitivity to chicken eggs and chicken protein, or other chicken-derived components;
• fever or poor general condition;
• acute or severe, or active heart, vascular, kidney, or liver disease;
• acute respiratory illness or other acute infectious diseases;
• seizures within 1 year prior to vaccination;
• Guillain-Barré syndrome within 6 weeks after a previous influenza vaccination or neurological disorders;
• diagnosed immunodeficiency disease;
• pregnancy;
• other conditions unsuitable for vaccination.

Special safety precautions.

Prior to administration, the vaccine should be warmed to room temperature, shaken, and visually inspected. The vaccine must not be used if there is any leakage from the vial, unclear labeling, or presence of any clumps that do not dissolve after shaking the vial. Use immediately after opening the vial. The vaccine should be used before the expiry date indicated on the label. Do not freeze. The vial is intended for single use only. Do not use any remaining suspension left in the vial after vaccination.

Interaction with other medicinal products and other types of interactions.

If any medications are being taken, including over-the-counter drugs, this must be reported to the physician prior to vaccination. If this vaccine is to be administered simultaneously with other injectable vaccines, they should be administered at different injection sites. Immunosuppressive therapy may affect the immune response to the vaccine (e.g., when taking corticosteroids, cytotoxic drugs, or undergoing radiotherapy).

Special precautions for use.

Epinephrine must be available in case anaphylactic reactions occur. Recipients should remain at the medical facility for at least 30 minutes after vaccination. The final decision on administering the vaccine is made by a physician. Exercise caution when administering to individuals with thrombocytopenia or coagulation disorders, as bleeding may occur at the injection site following intramuscular injection.

Use during pregnancy or breastfeeding.

Inform your doctor if you are pregnant or suspect you may be pregnant. The use of INFLUENZA VACCINE in pregnant women has not been studied. It is not known whether INFLUENZA VACCINE is excreted in human milk. However, since most medicinal products are excreted in breast milk, INFLUENZA VACCINE should not be administered during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

INFLUENZA VACCINE does not affect the ability to drive or operate machinery.

Dosage and Administration.

Dosing: 0.5 mL (one dose) for adults and children aged 9 years and older.

Route of administration: The vaccine is administered intramuscularly into the deltoid muscle of the shoulder.

Children: The vaccine is administered to children aged 9 years and older.

Vaccination must never be administered intravenously.

Vaccinations in Ukraine are carried out in accordance with the requirements of current orders issued by the Ministry of Health of Ukraine. Vaccinations are administered by medical personnel in preventive vaccination rooms of healthcare facilities.

Overdose.

Since the vaccine is administered only by healthcare professionals, the likelihood of overdose is negligible.

Adverse reactions.

Most common adverse reactions

In some patients, pain, increased sensitivity, redness, swelling, and itching at the injection site may occur within 24 hours after administration. Usually, these symptoms resolve within two to three days.

Some patients may experience a temporary increase in body temperature after vaccination, which subsides shortly thereafter without medical intervention.

Rare adverse reactions

Symptoms of a cold and general malaise, which resolve without medical intervention.

Severe febrile reaction: to prevent febrile seizures, a medical examination should be performed and symptomatic treatment administered.

Neuralgias, paresthesias, seizures, and transient thrombocytopenia.

Very rare adverse reactions

Pseudoallergic dermatitis: rashes may develop within 72 hours after vaccination. In such cases, immediate therapy for pseudoallergic dermatitis should be initiated.

Pseudoallergic purpura: individuals who develop pseudoallergic purpura after vaccination require immediate administration of cortisol. If appropriate measures are not taken promptly or if treatment is incorrectly chosen, nephritis may occur as a complication of pseudoallergic purpura.

To evaluate the safety of the medicinal product INFLUENZA VACCINE, phase III and phase IV clinical trials were conducted. Local and systemic adverse reactions are presented in Table 2.

Table 2. Safety data obtained during clinical trials

*Year of virus strains.

Expiry date. 12 months.

After the expiry date, the vaccine must be disposed of in accordance with the current legislation of Ukraine.

Storage conditions.

Store and transport in the original packaging, protected from light, at a temperature of 2–8 °C. Do not freeze. Keep out of reach of children. Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated on the packaging. Use immediately after opening. Do not store in opened form.

Incompatibility.

Due to lack of compatibility studies, this vaccine should not be mixed with other medicinal products.

Packaging.

0.5 mL (one dose) of injection suspension in hermetically sealed 2.0 mL ampoule glass vials, stoppered with a 12.5 mm grey bromobutyl rubber stopper and sealed with an aluminum cap with an orange tear-off ring, with 10 vials per cardboard box.

An orange-colored cap bears a vial monitor (Vaccine Vial Monitor).

Explanation regarding the vial monitor

Prescription category.

By prescription only.

Manufacturer.

Hualan Biological Bacterin Co., Ltd.

Manufacturer's address.

Jia no.1-1, Hualan Ave., Xinxiang, Henan, People’s Republic of China.

Applicant.

LLC "MEDTURKONSALT".

Applicant's address.

28/2, M. Hrushevskoho St., office 43, Kyiv, Ukraine, 02021.