Composition, form of production and packaging
Suspension for the / m introduction slightly opalescent; when settled, it is divided into a clear, colorless liquid and a white precipitate without flakes and foreign inclusions, which easily breaks when shaken.
0.5 ml (1 dose for children and adolescents )
antigen of hepatitis A virus 25 U *
Auxiliary substances: aluminum (in the form of aluminum hydroxyphosphate sulfate, amorphous) 0.225 mg, sodium borate decahydrate 0.035 mg, sodium chloride 4.5 mg, water d / and 0.5 ml.
0.5 ml - bottles of colorless glass (1) - packs of cardboard.
0.5 ml - bottles of colorless glass (10) - packs of cardboard.
0.5 ml - bottles of colorless glass (25) - packs of cardboard.
0.5 ml - bottles of colorless glass (100) - packs of cardboard.
0.5 ml - disposable syringes (1) - blister packs (1) - cardboard packs.
* - one ELISA corresponds to 1 ng of the protein of the hepatitis A virus.
** - fill the vials and syringes with an excess of 0.2 ml to ensure the recoverable volume.
Suspension for the / m introduction slightly opalescent; when settled, it is divided into a clear, colorless liquid and a white precipitate without flakes and foreign inclusions, which easily breaks when shaken.
1 ml (1 dose for adults)
antigen of hepatitis A virus 50 ED *
Excipients: aluminum (in the form of aluminum hydroxyphosphate sulfate, amorphous) - 0.45 mg, sodium borate decahydrate - 0.07 mg, sodium chloride 9 mg, water d / u - 1 ml **.
1 ml - bottles of colorless glass (1) - packs of cardboard.
1 ml - bottles of colorless glass (10) - packs of cardboard.
1 ml - bottles of colorless glass (25) - packs of cardboard.
1 ml - vials of colorless glass (100) - packs cardboard.
1 ml - disposable syringes (1) - blister packs (1) - cardboard packs.
* - one ELISA corresponds to 1 ng of the protein of the hepatitis A virus.
** - fill the vials and syringes with an excess of 0.2 ml to ensure the recoverable volume.
INSTRUCTION FOR THE SPECIALIST.
The description of the drug was approved by the manufacturer for the 2006 print edition.
PHARMACHOLOGIC EFFECT
The whole-viral vaccine against viral hepatitis A, obtained by culturing the virus in diploid cells of human fibroblasts MRS-5 (followed by its purification, inactivation with formalin and adsorption on aluminum hydroxide).
The course of immunization consists of 2 vaccinations - vaccination and revaccination.
After immunization, immunity develops after 14 days in 95-97% of vaccinated persons. Revaccination ensures the preservation of immunity for 6 years (for the entire observation period).
INDICATIONS
- prevention of viral hepatitis A in adults and children older than 2 years.
DOSING MODE
The vaccine is intended for intravenous administration only. Preferred injection site - deltoid muscle. It is forbidden to enter the vaccine in / in, or to / to.
The course of immunization consists of 2 vaccinations - vaccination and revaccination.
Children and adolescents aged 2 to 17 years once injected drug at a dose of 25 units. (0.5 ml). Revaccination is carried out at 6-18 months in the same dose (25 units).
Persons aged 18 years and older receive a single dose of 50 units at a time. (1.0 ml). Revaccination is carried out after 6 months in the same dose (50 units).
Vakta is produced in a ready-to-use form and does not need additional dilution.
Prior to the dose in the syringe, the vial must be shaken to form a translucent white suspension without foreign suspended particles.
SIDE EFFECT
Children and adolescents aged 2 to 17 years
On the part of the body as a whole: 3.1% - an increase in body temperature of more than 38.8 В° C.
On the part of the digestive system: 1% - diarrhea, vomiting; 1.6% - abdominal pain.
From the side of the central nervous system: 2.3% - a headache.
On the part of the respiratory system: 1.5% - pharyngitis; 1.1% - respiratory tract infection; 1% - cough.
Local reactions: 18.7% - pain; 16.8% - soreness when touched; 8.6% - a feeling of heat; 7.5% hyperemia; 7.3% - edema; 1.3% - subcutaneous hemorrhage.
Other: in some cases - increased activity of hepatic transaminases, eosinophilia, an increase in the protein content in the urine.
Data were obtained in combined clinical trials (2,595 healthy children and adolescents, including 1,037 participants in the placebo-controlled study). During the first 5 days after vaccination, temperature reactions, complaints of unpleasant sensations at the injection site were actively detected, and for 14 days - systemic complaints.
Information on the frequency of complaints registered with 1% or more of the vaccinated is given regardless of the cause of the occurrence.
Adults (persons aged 18 years and over)
On the part of the body as a whole: 3.1% - increase in body temperature above 38.8 В° C; 3.9% - weakness, fatigue.
From the digestive system: 2.4% - diarrhea; 2.3% - nausea; 1.3% - pain in the abdomen.
From the musculoskeletal system: 2% - myalgia; 1.3% - pain in the hands, 1.1% - back pain, 1% - stiffness of the muscles.
From the side of the central nervous system: 16.1% - headache.
On the part of the respiratory system: 2.7% - pharyngitis; 2.8% - infection of the upper respiratory tract; 1.1% - congestion of the nose.
On the part of the reproductive system: 1.1% - violation of menstruation.
Allergic reactions: less than 1% - skin itching, hives, skin rashes.
Local reactions: 52.6% - soreness when touched; 51.1% - pain, 17.3% - a feeling of heat; 13.6% - edema; 12.9% - hyperemia; 1.5% - subcutaneous hemorrhage; 1.2% - pain or burning.
Local reactions, as a rule, are weakly expressed and are of short duration.
Data were obtained in combined clinical trials (1,529 healthy subjects). During the first 5 days after vaccination, temperature reactions, complaints of unpleasant sensations at the injection site were actively detected, and for 14 days - systemic complaints.
Information on the frequency of complaints registered in 1% of vaccinated and more are given regardless of the cause of the occurrence.
CONTRAINDICATIONS
- a pronounced reaction to the previous administration of the drug (a rise in body temperature above 40 В° C, edema, hyperemia at the injection site of more than 8 cm);
- an allergic reaction of immediate type to the first administration of the drug;
- Acute or exacerbation of a chronic disease (with routine vaccination);
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Clinical and experimental studies to study the effect of the drug Vakta on reproductive function or on the development of the fetus were not carried out.
It is not known whether active substances of the drug are excreted in breast milk. During the lactation period (breastfeeding), the vaccine should be administered with caution.
APPLICATION FOR CHILDREN
Children and adolescents aged 2 to 17 years once injected drug at a dose of 25 units. (0.5 ml). Revaccination is carried out at 6-18 months in the same dose (25 units).
Safety and efficacy Vaccines in children under 2 years of age have not been established.
SPECIAL INSTRUCTIONS
When using Vakta in patients with malignant neoplasms or receiving immunosuppressants, as well as in individuals with immune system disorders, the expected immune response may not develop.
The vaccine does not prevent the occurrence of hepatitis caused by other pathogens.
In persons vaccinated in the incubation period of hepatitis A (duration - 20-50 days), the use of the drug may not prevent hepatitis A.
The vaccine can be used concurrently with the yellow fever vaccine and the inactivated typhoid vaccine, use with other vaccines is not recommended.
For the prevention of hepatitis A after contact with the causative agent of the disease or, if necessary, rapid and long-term prevention of the disease (for example, in persons urgently leaving for endemic areas), a vaccine can be administered simultaneously with an immunoglobulin by individual syringes in different parts of the body.
When the vaccine is introduced, it is necessary to have all the necessary medicines ready for relief of the anaphylactic or anaphylactoid reaction.
Use in Pediatrics
The vaccine is well tolerated and highly immunogenic for children over the age of 2 years.
Safety and efficacy Vaccines in children under 2 years of age have not been established.
DRUG INTERACTION
With simultaneous application, no drug interaction was established between the Vaccines with the yellow fever vaccine and the inactivated typhoid vaccine.Interaction studies There are no vaccines with other vaccines (such combinations are not recommended).
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature of 2 В° to 8 В° C. Shelf life - 3 years. At the end of the expiration date the drug is not subject to application.
The vaccine should not be frozen. this leads to a loss of its effectiveness.
