Expiration date: 01/2026
Active substance
Vaccine for the prevention of viral hepatitis A (Vaccine hepatitis A)
ATX
J07BC02 Hepatitis A virus inactivated whole
Nosological classification (ICD-10)
list of codes mkb-10
Pharmacological group
Vaccines, serums, phages and anatoxins
Dosage form
Suspension for intramuscular injection.
Composition
1 vaccination dose for adults (1 ml) contains:
Active substance
Inactivated hepatitis A virus antigen (HCV) — at least 320 ELISA units;
Auxiliary substances
Aluminum hydroxide, formaldehyde, 0.01 M phosphate-salt buffer solution (sodium hydrophosphate dodecahydrate, sodium chloride, water for injection).
The vaccine does not contain preservatives and antibiotics
1 vaccination dose for children (0.5 ml) contains:
Active substance
Inactivated hepatitis A virus antigen (HCV) — at least 160 ELISA units;
Auxiliary substances
Aluminum hydroxide, formaldehyde, 0.01 M phosphate-salt buffer solution (sodium hydrophosphate dodecahydrate, sodium chloride, water for injection).
The vaccine does not contain preservatives and antibiotics.
Characteristic
ALGAVAC®?M — vaccine for the prevention of viral hepatitis A. The vaccine is a suspension of inactivated hepatitis A virus virions (strain LBA?86) grown on a culture of 4647 transferable cells approved for the production of vaccines, purified, concentrated and adsorbed on aluminum hydroxide gel.
Description of the dosage form
Slightly opalescent suspension, when settling, is divided into 2 layers: the upper one is a transparent, colorless liquid; the lower one is a white precipitate, easily broken when shaken, without the formation of flakes and foreign inclusions.
Indications
Prevention of viral hepatitis A in adults and children from the age of three.
Persons who are or will be at risk of contracting viral hepatitis A are subject to vaccination.:
- Persons living in territories with a high incidence of hepatitis A;
- Persons traveling to regions with a high incidence of hepatitis A (military personnel, travelers, etc.);
- Persons who are in contact with foci;
- Persons at occupational risk of infection: medical personnel and nursing staff (especially in infectious, gastroenterological and pediatric departments); staff of preschool institutions; employees of sewage and water supply services; personnel of the food industry and catering enterprises;
- Persons from among special risk groups (patients with chronic liver diseases or an increased risk of liver disease; patients with hemophilia; patients with multiple hemotransfusions; drug addicts; homosexuals; persons leading a promiscuous sexual life).
Vaccinations can also be given to other groups of the population.
Contraindications
- Severe reaction (temperature above 40 °C, at the injection site of the vaccine — edema and hyperemia over 8 cm in diameter) or hypersensitivity to the previous administration of the ALGAVAC® M vaccine.
- Hypersensitivity to any of the components of the vaccine.
- Acute infectious and non-communicable diseases, exacerbation of chronic diseases are temporary contraindications for vaccinations. Routine vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence or remission. With mild acute respiratory viral infections, acute intestinal diseases, vaccinations are carried out after the temperature normalizes.
- Children under 3 years of age.
With caution
In order to identify contraindications, a doctor (paramedic) on the day of vaccination should conduct an examination and survey of the vaccinated person with mandatory thermometry.
Vaccination sites should be provided with anti-shock therapy. The vaccinated person should be under medical supervision for 30 minutes after immunization.
Use during pregnancy and lactation
Clinical studies on the effect of the ALGAVAC® vaccine?M on the fetus in pregnant women and infants when the vaccine was administered to nursing mothers were not carried out. The decision to vaccinate pregnant women and women during breastfeeding is possible if the intended benefit to the mother exceeds the potential risk to the fetus and child.
Method of administration and dosage
The vaccine is injected intramuscularly into the area of the deltoid muscle (shoulder area).
Before the introduction of ALGAVAC®?M must be checked for the absence of extraneous inclusions or changes in appearance. Before entering the dose into the syringe, the ampoule with the vaccine must be vigorously shaken until a homogeneous, slightly cloudy suspension of white color is formed.
Do not use a drug that has been frozen. If the contents of the ampoule do not correspond to the description of the drug or contain foreign inclusions, then the packaging with the vaccine must be destroyed.
The opening of the ampoule and the vaccination procedure are carried out in strict compliance with the rules of asepsis.
The vaccine cannot be administered intravenously!
It is not recommended to inject the vaccine intramuscularly into the gluteal region, subcutaneously or intradermally, as this leads to the formation of a lower immune response.
Vaccination scheme
The full course of vaccination, which provides long?term protection against infection with viral hepatitis A, consists of 2 vaccinations (vaccination and revaccination), carried out at intervals of 6-12 months.
Children from 3 years old and teenagers up to 17 years old inclusive:
- the vaccine is administered in a single dose of 0.5 ml;
- revaccination is carried out after 6-12 months in a single dose of 0.5 ml.
Adults aged 18 years and older:
- the vaccine is administered in a single dose of 1 ml;
- revaccination is carried out after 6-12 months in a single dose of 1 ml.
In exceptional cases, revaccination is allowed at a later date after the first dose is administered.
Overdose
Cases of ALGAVAC® overdose?M are not registered.
Side effects
ALGAVAC® Vaccine?M is weakly reactogenic. The frequency of adverse reactions (HP) was determined as follows: very frequent >10%, frequent >1% and <10%, infrequent >0.1% and <1%, rare >0.01% and <0.1%, very rare <0.01%.
Frequency categories were formed based on data from clinical trials of the vaccine and post-registration observation.
General disorders and local reactions:
Very often — soreness and hyperemia of the skin at the injection site;
Often — headache, dizziness, fever (>37.0 ° C), mild infiltration at the injection site;
Very rarely — muscle twitching at the injection site.
All adverse reactions were short-term (no more than 24 hours) and did not require medical treatment.
Special instructions
The vaccine does not protect against viral hepatitis B, C and E, as well as other infectious liver diseases.
Vaccination carried out during the incubation period of hepatitis A disease may not be effective enough.
People undergoing treatment with immunostimulants or immunosuppressants and HIV-infected people may have a weak immune response to the introduction of the vaccine.
Influence on the ability to drive vehicles, mechanisms
Application of ALGAVAC®?M does not have a negative impact on the performance of activities that require increased concentration of attention and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, the work of a dispatcher and operator, etc.).
Interaction
ALGAVAC®?M can be administered simultaneously (on the same day) or at intervals of 1 month with other inactivated vaccines of the National Calendar of Preventive Vaccinations and the calendar of preventive vaccinations for epidemic indications (with the exception of the anti-rabies vaccine).
Vaccines are injected with separate syringes into different parts of the body.
The vaccine should not be mixed in one syringe with other vaccines.
ALGAVAC®?M can be used for revaccination in cases where the previous vaccination was carried out with other inactivated vaccines for the prevention of hepatitis A.
Release form
Suspension for intramuscular administration of 0.5 ml (1 child dose); 1 ml (1 adult dose) in ampoules or 0.5 ml (1 child dose); 1 ml (1 adult dose) in single-dose syringes.
10 ampoules with a "snake" type insert made of cardboard in cardboard boxes with instructions for use and an ampoule scarifier (if necessary).
1 syringe with a needle in a cap in a closed contour cell package made of polyvinyl chloride (PVC) film, covered with aluminum foil with heat-sealable varnishes on one side in a cardboard box with instructions for use.
Conditions of release from pharmacies
For medical and preventive institutions.
Expiration date
2 years.
Do not use after the expiration date indicated on the package.
Storage conditions
In accordance with SP 3.3.2.3332-16 at a temperature from 2 to 8 ° C. Do not freeze.
Keep out of reach of children.
Transportation conditions
In accordance with SP 3.3.2.3332-16 at a temperature from 2 to 8 ° C. Do not freeze.
