Pandeflu (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BB02 (Influenza virus inactivated split or surface antigen)

Active Substance

Inactivated influenza vaccine

Dosage Form

Pandeflu

Suspension for intramuscular administration 0.5 ml/1 dose: ampoules 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration

¹ adsorbed on aluminum hydroxide

0.5 ml (1 dose) – ampoules (10 pcs.) – cardboard boxes – for healthcare institutions
0.5 ml (1 dose) – ampoules (10 pcs.) – cardboard packs – for healthcare institutions contour (2) – cardboard packs.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine consists of surface glycoproteins (hemagglutinin and neuraminidase) isolated from purified virions of the influenza virus type A/California/7/2009 (H₁N₁)v, grown in chicken embryos, and adsorbed on aluminum hydroxide.

The vaccine induces the formation of specific immunity in humans against influenza type A/H₁N₁/.

Indications

• Specific prophylaxis of influenza type A/H₁N₁/ in individuals aged 18-60 years.

ICD codes

Dosage Regimen

The vaccine is administered once intramuscularly into the upper third of the outer surface of the shoulder (deltoid muscle area) in a dose of 0.5 ml. Before administration, the ampoule with the drug must be shaken until a homogeneous suspension is obtained.

The drug is unsuitable for use in ampoules with damaged integrity or labeling, after the expiration date, or if stored improperly.

The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis. The drug in an opened ampoule must not be stored.

The performed vaccination is recorded in the established registration forms indicating the date of drug administration, dose, batch number, and the name of the manufacturer.

Adverse Reactions

Reactions at the injection site may occur in the form of pain, redness, and swelling of the skin. Some individuals may experience general reactions in the form of increased fatigue, headache, dizziness, subfebrile temperature, rhinitis, 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 influenza vaccines;
• Acute infectious and non-infectious diseases, chronic diseases in the acute stage – vaccination is carried out no earlier than one month after recovery (remission). For mild acute respiratory viral infections, acute intestinal diseases, vaccination is carried out after temperature normalization;
• Vaccination with anti-rabies vaccines less than 2 months before immunization;
• Systemic connective tissue diseases;
• Adrenal gland diseases;
• Hereditary, degenerative and progressive diseases of the nervous system;
• Pregnancy;
• Lactation;
• Hypersensitivity to chicken protein.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

In acute infectious and non-infectious diseases, chronic diseases in the acute stage – vaccination is carried out no earlier than one month after recovery (remission).

Use in Renal Impairment

In acute infectious and non-infectious diseases, chronic diseases in the acute stage – vaccination is carried out no earlier than one month after recovery (remission).

Special Precautions

All persons subject to vaccination must be examined by a doctor, taking into account anamnestic data.

On the day of immunization, those to be vaccinated should be examined by a doctor with mandatory thermometry. Vaccination is not performed if body temperature is 37°C (98.6°F) or higher. The doctor is responsible for the correct prescription of the vaccine.

The possibility of vaccinating persons suffering from chronic diseases not listed in the contraindications is determined by the attending physician, based on the patient’s condition.

Precautionary measures

Do not administer intravenously. In the rooms where vaccination is carried out, it is necessary to have medications for anti-shock measures and relief of 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 (determined by the attending physician). 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

The drug is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature from 2°C (35.6°F) to 8°C (46.4°F) in a place inaccessible to children. Freezing is not allowed.

Shelf Life

Shelf life – 1 year. After the expiration date, the drug must not be used.

Dispensing Status

For healthcare institutions.

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.