Вакта®

General characteristics. Structure:

Active ingredient: 25 PIECES or 50 PIECES of antigen of a virus of hepatitis A.

Excipients: aluminum (in the form of aluminum hydroxyphosphate of sulfate, amorphous), borate sodium decahydrate, sodium chloride, water for injections.

Pharmacological properties:

Pharmacodynamics. The Tselnovirionny vaccine against a viral hepatitis And, MRS-5 received by cultivation of a virus in diploid cells of fibroblasts of the person (with the subsequent its cleaning, an inactivation with formalin and adsorption on aluminum hydroxide).

The course of immunization consists of 2 inoculations - vaccination and revaccinations.

Pharmacokinetics. After vaccination immunity develops in 14 days at 95-97% of vaccinated persons. The revaccination provides preservation of immunity within 6 years (for the entire period of observation).

Indications to use:

— prevention of a viral hepatitis And at adults and children is more senior than 2 years.

Route of administration and doses:

Vakta is intended only for introduction in oil. The preferable place of an injection - a deltoid muscle. It is forbidden to enter a vaccine in/in, п / to or boiled and smoked.

The course of immunization consists of 2 inoculations - vaccination and revaccinations.

To children and teenagers aged from 2 up to 17 years once administer the drug in a dose of 25 units (0.5 ml). The revaccination is carried out in 6-18 months in the same dose (25 pieces).

To persons at the age of 18 years is also more senior once administer the drug in a dose of 50 units (1.0 ml). The revaccination is carried out in 6 months in the same dose (50 units).

Vakta is issued in a look, ready for use, and does not need additional cultivation.

Before a set of a dose in the syringe the bottle needs to be stirred up for formation of translucent suspension of white color without foreign suspended particles.

Features of use:

Use at pregnancy and feeding by a breast. Clinical and pilot studies on studying of effect of drug of Vakt on reproductive function or on fetation it was not carried out.

It is unknown whether active agents of drug with breast milk are emitted. In the period of a lactation (breastfeeding) it is necessary to appoint a vaccine with care.

Use for children. To children and teenagers aged from 2 up to 17 years once administer the drug in a dose of 25 units (0.5 ml). The revaccination is carried out in 6-18 months in the same dose (25 pieces).

Safety and Vakta's efficiency at children under 2 years is not established.

Special instructions. At Vakta's use for patients with malignant new growths or receiving immunodepressants, and also at persons with disturbances of immune system the expected immune response can not develop.

Vakta does not prevent developing of the hepatitises caused by other activators.

At the persons vaccinated in a hepatitis A incubation interval (duration - 20-50 days), use of drug can not prevent diseases of hepatitis A.

Vakta can be applied along with a vaccine against yellow fever and the inactivated typroid vaccine, use with other vaccines is not recommended.

For prevention of hepatitis A after contact with an infestant or in need of bystry and long-term prevention of a disease (for example, at the persons which are urgently leaving to endemic areas) Vakta can be entered along with immunoglobulin separate syringes into different body parts.

At introduction of a vaccine it is necessary to have all necessary medicines for stopping of anaphylactic or anaphylactoid reaction.

Use in pediatrics. Vakta well is transferred and is highly immunogene for children 2 years are aged more senior.

Safety and Vakta's efficiency at children under 2 years is not established.

Side effects:

Children and teenagers aged from 2 up to 17 years.

From an organism in general: 3.1% - fervescence more than 38.8 °C.

From the alimentary system: 1% - diarrhea, vomiting; 1.6% - abdominal pains.

From TsNS: 2.3% - a headache.

From respiratory system: 1.5% - pharyngitis; 1.1% - respiratory infection; 1% - cough.

Local reactions: 18.7% - pain; 16.8% - morbidity at a touch; 8.6% - feeling of heat; 7.5% - a hyperemia; 7.3% - hypostasis; 1.3% - hypodermic hemorrhages.

Others: in some cases - increase in activity of hepatic transaminases, an eosinophilia, increase in protein content in urine.

Data are obtained in the joint clinical trials (2595 healthy children and teenagers, including 1037 participants of placebo - a controlled research). During the first 5 days after vaccination temperature reactions, complaints to unpleasant feelings in the place of an injection, for 14 days - complaints of system character actively came to light.

Data on the frequency of the complaints registered at 1% and more vaccinated are provided regardless of origins.

Adults (persons at the age of 18 years are also more senior).

From an organism in general: 3.1 the % - fervescence is above 38.8 °C; 3.9% - weakness, fatigue.

From the alimentary system: 2.4% - diarrhea; 2.3% - nausea; 1.3% - abdominal pains.

From a musculoskeletal system: 2% - a mialgiya; 1.3% - hand pain, 1.1% - a dorsodynia, 1% - constraint of muscles.

From TsNS: 16.1% - a headache.

From respiratory system: 2.7% - pharyngitis; 2.8% - an infection of upper parts of respiratory tracts; 1.1% - a nose congestion.

From a reproductive system: 1.1% - disturbance of periods.

Allergic reactions: less than 1% - a skin itch, a small tortoiseshell, skin rash.

Local reactions: 52.6% - morbidity at a touch; 51.1% - pain, 17.3% - feeling of heat; 13.6% - hypostasis; 12.9% - a hyperemia; 1.5% - hypodermic hemorrhage; 1.2% - pain or burning.

Local reactions are, as a rule, poorly expressed and have short-term character.

Data are obtained in the joint clinical trials (1529 healthy faces). During the first 5 days after vaccination temperature reactions, complaints to unpleasant feelings in the place of an injection, and for 14 days - complaints of system character actively came to light.

Data on the frequency of the complaints registered at 1% vaccinated and more are provided regardless of origins.

Interaction with other medicines:

At simultaneous use medicinal interaction of Vakta with a vaccine against yellow fever and the inactivated typroid vaccine is not established.

Researches of interaction of Vakta with other vaccines are absent (such combinations do not recommend).

Contraindications:

— the expressed reaction to the previous administration of drug (rise in body temperature is above 40 °C, hypostasis, a hyperemia in the place of an injection more than 8 cm);

— allergic reaction of immediate type to the first administration of drug;

— acute or an exacerbation of a chronic disease (when performing planned immunization);

— hypersensitivity to drug components.

Storage conditions:

Drug should be stored at a temperature from 2 °C to 8 °C. A period of validity - 3 years. Upon termination of a period of validity drug is not subject to use. The vaccine cannot be frozen since it leads to loss of its efficiency.

Issue conditions:

According to the recipe

Packaging:

0.5 ml - bottles of colourless glass (1) - a pack cardboard.
0.5 ml - bottles of colourless glass (10) - a pack cardboard.
0.5 ml - bottles of colourless glass (25) - a pack cardboard.
0.5 ml - bottles of colourless glass (100) - a pack cardboard.
0.5 ml - syringes one-time (1) - packagings the blister (1) - packs cardboard.

* - one IFA unit corresponds 1 нг a squirrel of a virus of hepatitis A.
** - when filling bottles and syringes put surplus of 0.2 ml for ensuring the taken volume.