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

Excipients: Potassium chloride 0.1 mg, potassium dihydrogen phosphate 0.1 mg, sodium phosphate dihydrate 0.67 mg, sodium chloride 4.0 mg, calcium chloride dihydrate 0.067 mg, magnesium chloride hexahydrate 0.05 mg, water for injections up to 0.5 ml, sodium citrate <1.0 mg, CTAB <15 μg, sucrose <0.2 mg, formaldehyde <0.01 mg, polysorbate-80 - traces.

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:

Indications:

Contraindications:

Hypersensitivity to any component of the vaccine or to substances that can be contained in residual amounts: chicken protein, formaldehyde, CTAB, polysorbate-80 and gentamycin.

Children younger than 6 months. (efficiency and safety not established).

Vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases. With mild ARVI, acute intestinal diseases, etc., vaccination is carried out immediately after the temperature is normalized.

Dosing and Administration:

- Dose for adults and adolescents (from age 14): 0.5 ml. The vaccine is administered once.

- Dose for children from 3 to 14 years: 0.5 ml; dose for children from 6 months of age and up to 3 years: 0.25 ml. The vaccine is administered once. Children who have not previously been vaccinated are recommended to enter the vaccine twice, at intervals of 4 weeks.

Mode of application. Immunization is carried out annually in the autumn period. The vaccine is administered intramuscularly or deep subcutaneously.

It is strictly forbidden to administer the drug intravenously.

Before administration, the vaccine should be warmed to room temperature.Shake the syringe and visually check for the absence of foreign particles immediately before injection. Remove the protective cap from the needle and remove air from the syringe by holding it upright with a needle and slowly pressing the piston. When a dose of 0.25 ml is introduced, the movement of the syringe piston is stopped at the moment when its inner surface reaches the lower edge of the needle retainer.

Side effects:

During clinical trials, the following adverse reactions were noted frequently (> 1/100 to <1/10):

From the nervous system: headache.

From the skin and subcutaneous cellulose: Pthe difference.

From the side of the musculoskeletal system: myalgia, arthralgia.

General disorders: fever, malaise, chills, fatigue.

Local Reactions: redness, swelling, pain, tightness, ecchymosis.

Reactions usually take place within 1-2 days and do not require treatment.

During the post-marketing surveillance, the following adverse reactions were noted:

Co hand circulatory and lymphatic system:

Transient thrombocytopenia,transitional lymphadenopathy.

From the immune system:

Allergic reactions, in rare cases - anaphylactic shock, angioedema.

From the nervous system:

Neuralgia, paresthesia, febrile seizures, encephalomyelitis,

Neurological disorders, such as neuritis, Guillain-Barre syndrome.

From the side of the vascular system:

Vasculitis, in very rare cases associated with transient renal dysfunction.

From the skin and subcutaneous tissue:

Generalized skin reactions, including itching, hives, or rashes.

Interaction:

Special instructions:

Effect on the ability to drive transp. cf. and fur:

Influvac® does not or has little effect on the ability to drive vehicles and machinery.

Form release / dosage:Suspension for intramuscular and subcutaneous administration.

Packaging:

For 0.5 ml in a disposable syringe with a capacity of 1.0 ml with a needle closed with a plastic cap. For 1 or 10 syringes in a cardboard bundle.

One syringe and instructions for use are placed in a cardboard box with the control of the first opening.

Ten syringes and instructions for use are placed in a cardboard box with the control of the first autopsy.

Storage conditions:

The storage conditions and of transportation

Store and transport in a dark place at a temperature of 2 ° C to 8 ° C, do not freeze. Keep out of the reach of children.

Terms of leave from pharmacies:On prescription

Registration number:P N 015694/01

Date of registration:27.04.2009

The owner of the registration certificate:Abbott Biolodicals BVAbbott Biolodicals BV Netherlands

Manufacturer: & nbsp

ABBOTT BIOLOGICALS, B.V. Netherlands

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp30.03.2015

Illustrated instructions

Instructions

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Influvac® (Influvac®)