Pandeflu - instructions for use, dose, side effects, contraindications

In 1 dose (0.5 ml) of the vaccine contains: hemagglutinin of the influenza virus type A / HiNj / - (15 ± 2,2) μg, aluminum hydroxide - (0,475 + 0,075) mg.

Preservative - thiomersal (merthiolate) - (50 ± 7.5) μg.

The composition of the vaccine varies according to the recommendations of the WHO and / or the Commission on influenza vaccine and diagnostic strains.

Description:

A suspension of white color without foreign inclusions, separated upon settling on a transparent supernatant and a loose sediment, completely broken up by shaking.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07.B.01.01 Influenza virus - inactivated whole virus

J.07.B.B Vaccine for the prevention of influenza

Pharmacodynamics:

Immunobiological properties.

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

Indications:

Specific prevention of influenza type A/H1N1/ in children from 12 years of age and adults without age restriction.

Contraindications:

1. Allergic reactions to influenza vaccines.

2. Acute infectious and non-infectious diseases, chronic diseases in the acute stage - vaccination is carried out not earlier than a month after recovery (remission). For non-severe acute respiratory viral infections, acute intestinal diseases, vaccination is carried out after normalizing the temperature.

3. Hypersensitivity to chicken protein.

4. Vaccinated with rabies vaccines less than 2 months before immunization.

5. Systemic diseases of connective tissue.

6. Diseases of the adrenal glands.

7. Hereditary, degenerative and progredient diseases of the nervous system.

8. Pregnancy and lactation.

The possibility of vaccination of persons suffering from chronic diseases not listed in the list of contraindications is determined by the attending physician based on the patient's condition. All persons subject to vaccination should be examined by a doctor in the light of anamnestic data.

On the day of immunization, the vaccinated should be examined by a physician with mandatory thermometry. At a body temperature of 37 ° C or higher, there is no vaccination. The doctor is responsible for the correct administration of the vaccine.

Pregnancy and lactation:The use is contraindicated.

Dosing and Administration:

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

The drug is not suitable for use in ampoules with broken integrity or marking, with expired shelf life, improper storage.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The drug in the opened ampoule is not subject to storage.

Vaccination is recorded in the prescribed registration forms with the date of administration of the drug, dose, serial number and name of the manufacturer.

Precautions for use. Do not administer intravenously! AT offices where the vaccination is carried out, it is necessary to have medicines for carrying out anti-shock measures and arresting the anaphylactic reaction.

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

Side effects:

In the place of administration of the vaccine there may be reactions in the form of pain, redness and swelling of the skin. Individuals may have general reactions 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.

Overdose:

Not installed.

Interaction:

The vaccine can be administered against the background of basic therapy of the underlying disease (determined by the attending physician). 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.

Effect on the ability to drive transp. cf. and fur:Not installed.

Form release / dosage:

Suspension for intramuscular injection.

Packaging:In ampoules of 0.5 ml (1 dose).

For 10 ampoules in a box of cardboard along with instructions for use and a scapegrator ampoule.

5 ampoules in the outline of the cell. 2 contour squares are placed in a pack of cardboard together with an instruction for use and a scapegrator ampoule.

When packing ampoules with a ring of fracture or a point for opening, the ampoule scaper is not inserted.

Storage conditions:

Storage and transportation conditions. Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children. Freezing is not allowed.

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

Shelf life:

1 year.After the expiration date, the drug is not applicable.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007987/09

Date of registration:13.10.2009

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Information update date: & nbsp07.11.2013

Illustrated instructions

Instructions

Pandeflu (Pandeflu)