Inflexal V - instructions for use, dose, side effects, contraindications

Infleksal®V inactivated trivalent influenza virus vaccine, is a system comprising virosomes highly purified surface antigen of influenza virus type A and B, cultured in chick embryos. The antigenic composition of the vaccine is updated annually in accordance with the recommendations of the World Health Organization. Active Ingredients:One dose of adult vaccine (0.5 mL) contains

Hemagglutinin influenza virus *:

................................. A (H 1N1) -like .. 15 μg

................................. А (НЗШ) -like ...... 15мкг

................................. B-like ... 15μg

* Indicated in accordance with WHO recommendations for this epidemic season

Excipients:

sodium chloride - 2.4 mg Sodium hydrogen phosphate dihydrate - 3.8 mg of potassium dihydrogen phosphate - 0.7 mg Lecithin - 117 mg Water for injection - up to 0.5 ml.

Description:Colorless, clear liquid

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:

Immunological properties

The seroprotective level of antibodies is usually achieved in 2-3 weeks. The duration of postvaccination immunity to homologous strains or strains, close to vaccinal varies, but usually is 6-12 months.

Indications:

Prevention of influenza from 6 months of age, especially among people at high risk for complications associated with influenza.

Contraindications:

Hypersensitivity to the active components of the vaccine or any of the excipients, to chicken egg and chicken protein, polymyxin B or neomycin.

Immunization should be postponed if the patient has an acute infectious disease or febrile condition.

Pregnancy and lactation:

Available data on immunization with Inflaxal® V vaccine in pregnant women do not indicate a negative effect on the fetus and mother. The possibility of using the Inflaxal® V vaccine can be considered starting from the second trimester of pregnancy. For pregnant women with conditions that increase the risk of complications associated with influenza, the vaccine is indicated regardless of the gestational age.

The vaccine can be used during lactation.

Dosing and Administration:

Adults and children older than 36 months: 0.5 ml.

Children aged 6 to 35 months: 0.25 ml or 0.5 ml.

Children who have not previously been vaccinated should re-enter the appropriate dose of the vaccine with an interval of at least 4 weeks.

Immunization should be carried out by intramuscular or deep subcutaneous injection.

Allow the vaccine to warm to room temperature before use. Shake well before administration.

If a dose of 0.25 ml is prescribed, half the volume of the vaccine is removed from the syringe to the risks, keeping the syringe in the upright position. The remaining volume is entered.

Side effects:

Local reactions: redness, swelling, soreness, tightness, bruising.

Systemic reactions: fever, malaise, chills,fatigue, headache, sweating, myalgia, arthralgia.

These reactions usually take place within 1-2 days without treatment.

Rarely arise generalized skin reactionsincluding itching, hives, or an allergic rash. It is very rare to have neuralgia, paresthesia, seizures, short thrombocytopenia. In extremely rare cases, severe allergic reactions are possible, including anaphylactic shock. Very rarely there is vasculitis with transient renal impairment, neurological disorders such as encephalomyelitis, neuritis, Guillain-Barre syndrome.

Overdose:

Any adverse effects due to an overdose are unlikely.

Interaction:

Immunization with Infflaxal® V vaccine can be carried out simultaneously with immunization with other vaccines, but they must be injected with different syringes into different parts of the body. It should be noted the possibility of developing more pronounced adverse reactions.

The immune response may be decreased in patients receiving immunosuppressive therapy.

Special instructions:

The Inflexal ® V vaccine is categorically forbidden to be administered intravenously.

As with any injection vaccine, medical supervision is necessary. Places of vaccination should be equipped with anti-shock therapy.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be inadequate.

After the vaccination against the flu, false-positive results of the diagnosis by the enzyme immunoassay for the presence of antibodies to HIV-1, the hepatitis C virus, and especially the human T-cell leukemia virus (HTLV-1). The application of the western blotting method in these cases gives a negative result. This effect is transient, it can be caused by products IgM antibodies in response to the administration of the vaccine.

Incompatibility

In view of the fact that no compatibility study has been conducted, Inflexal® V should not be confused with other drugs

Form release / dosage:

Suspension for intramuscular or subcutaneous administration.

Packaging:0.5 ml in a disposable sterile glass syringe with a needle.

One syringe in a plastic blister. For 1 or 10 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

Transportation conditions

At a temperature of 2 to 8 ° C.

Storage conditions

At a temperature of 2 to 8 ° C.

Do not freeze: do not use if the vaccine was accidentally frozen. Keep out of the reach of children.

Shelf life:

1 year.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-003255/07

Date of registration:17.10.2007 / 18.05.2012

Expiration Date:Unlimited

Date of cancellation:2016-11-15

The owner of the registration certificate:Berna Biotech Co., Ltd.Berna Biotech Co., Ltd.

Manufacturer: & nbsp

Berna Biotekh Ltd. Switzerland

Representation: & nbspBerna Biotech Co., Ltd.Berna Biotech Co., Ltd.

Information update date: & nbsp26.10.2017

Illustrated instructions

Instructions

Inflexal® V (Inflexal V)