Agrippal S1 (Suspension) Instructions for Use

ATC Code

J07BB02 (Influenza virus inactivated split or surface antigen)

Active Substance

Inactivated influenza vaccine (surface antigen)

Inactivated influenza vaccine (surface antigen) (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Vaccine for the prophylaxis of influenza. It is a trivalent subunit inactivated influenza vaccine consisting of surface antigens (hemagglutinin /HA/, neuraminidase /NA/) of influenza type A and B viruses cultured on chicken embryos from healthy chickens.

The antigenic composition of the influenza vaccine is updated annually according to WHO recommendations.

The vaccine induces the development of specific immunity to influenza type A and B viruses, which usually occurs within 14 days after immunization and lasts up to 1 year.

Indications

Prophylaxis of influenza in adults and children over 6 months of age.

Vaccination is recommended for all individuals and, first of all, the following population categories at increased risk in case of combination of influenza with existing diseases: patients over 65 years of age regardless of their health status; patients with respiratory diseases, including bronchial asthma; patients with cardiovascular diseases of any etiology; patients with chronic renal failure; patients with chronic metabolic disorders, including diabetes mellitus; patients with immunodeficiency diseases and patients receiving immunosuppressants, cytostatics, radiation therapy or high-dose corticosteroids; children and adolescents aged 6 months to 18 years, receiving long-term medications containing acetylsalicylic acid, and therefore at increased risk of developing Reye’s syndrome due to influenza infection.

ICD codes

Dosage Regimen

Administer the vaccine by intramuscular or deep subcutaneous injection.

For adults and children from 36 months, administer a single 0.5 mL dose.

For children from 6 months to 35 months, administer a 0.25 mL dose.

For children under 9 years receiving the vaccine for the first time, administer a second dose after an interval of at least 4 weeks.

Perform the injection carefully to avoid intravascular administration.

Do not administer intravenously under any circumstances.

Shake the pre-filled syringe immediately before use.

Inspect the vaccine visually for any particulate matter or discoloration prior to administration.

Use a separate sterile syringe and needle for each individual.

Discard any unused vaccine or waste material according to standard procedures.

Adverse Reactions

Nervous system disorders headache, neuralgia, paresthesia, convulsions, encephalomyelitis, neuritis, Guillain-Barré syndrome.

Dermatological reactions increased sweating, generalized skin reactions, including itching, urticaria or non-specific rash.

Musculoskeletal system disorders myalgia, arthralgia.

Local reactions redness, swelling, soreness, induration*, ecchymosis.

Other increased body temperature, malaise, chills, fatigue.

Hematopoietic system disorders transient thrombocytopenia, transient lymphadenopathy.

Allergic reactions manifestations of allergic reactions; in some cases – angioedema, anaphylactic shock.

Cardiovascular system disorders vasculitis in very rare cases accompanied by transient renal impairment.

Contraindications

Hypersensitivity to chicken protein or other components of the vaccine; hypersensitivity reactions to substances that may be contained in residual amounts – formaldehyde, CTAB, polysorbate-80 and gentamicin.

Vaccination of patients should be postponed until the acute manifestations of the disease and exacerbation of chronic diseases have subsided. For mild ARVI, acute intestinal diseases, vaccination is carried out immediately after the temperature normalizes.

Use in Pregnancy and Lactation

Does not have a teratogenic or toxic effect on the fetus. Can be used from the second trimester of pregnancy. Pregnant women belonging to the risk group should be vaccinated regardless of the gestational age.

Can be used during lactation (breastfeeding).

Use in Hepatic Impairment

The drug is approved for use in hepatic impairment

Use in Renal Impairment

The drug is approved for use in renal impairment

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age

Geriatric Use

The drug is approved for use in elderly patients

Special Precautions

During vaccination, all means for emergency therapy of anaphylactic shock (including epinephrine/adrenaline, corticosteroids) must be available.

In patients with endogenous or exogenous immunosuppression, the immune response may be insufficient.

1 vaccine dose should not contain more than 1 µg of ovalbumin.

After vaccination, false-positive results of serological tests based on the ELISA method (enzyme-linked immunosorbent assay) may be obtained when determining antibodies against HIV (HIV1), hepatitis C, and human T-cell lymphotropic virus (HTLV1). Laboratory diagnostics using the Western Blot method allows to exclude false-positive results of tests based on the ELISA method. Transient false-positive results may be due to IgM production after vaccination.

Drug Interactions

Can be used simultaneously with other vaccines (in this case, vaccines should be administered into different parts of the body with different syringes). Side effects may be enhanced.

In patients receiving immunosuppressive therapy, the immune response to vaccination may be reduced.

It is not recommended to extract the vaccine from the syringe and use it in a mixture with other drugs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.