Algavac M instructions for use

"Algavac-M" - a vaccine for the prevention of hepatitis A

Culture purified inactivated vaccine

, Russia.

Protects against viral disease: hepatitis A.

Try on: for adults and small children from the age of three.

Included in the national calendar of preventive vaccinations in Russia.

IMPORTANT: vaccinations with the Algavac-M vaccine are not carried out in clinics

Advantages of the ALGAVAK-M vaccine:

  • A single administration of the vaccine stimulates the rapid development of specific cellular and humoral immunity factors and the production of antibodies to the hepatitis A virus;
  • A full course of vaccination, consisting of two vaccinations carried out with an interval of 6-12 months, activates the additional production of virus-neutralizing antibodies in high titers and the creation of long-term intense immunity to the hepatitis A virus;
  • Vaccination prevents the spread of infection, since protective antibodies appear in the blood already 15 days after vaccination;
  • Unlike many foreign analogues, the drug does not contain antibiotics or preservatives;
  • The vaccine is produced according to international GMP production quality standards;
  • The vaccination effectiveness rate is 98.6%.
  • A full course of vaccination ensures the development of specific immunity for 12-15 years in 90-95% of vaccinated people.

Pharmacological properties

Algavak M is a vaccine consisting of hepatitis A virions (strain LBA-86), grown on an approved for production culture of continuous cells 4647, purified, concentrated, inactivated and adsorbed on aluminum hydroxide gel.

A full course of immunization (administration of two doses of the Algavac M vaccine with an interval of 6–12 months) activates additional production of antibodies in high titers, which ensures the development of long-term specific immunity to the hepatitis A virus in 90–100% of those vaccinated.

Indications for vaccination "ALGAVAK-M"

Persons who are or will be at risk of contracting viral hepatitis A are subject to vaccination:

  • persons living in areas with a high incidence of hepatitis A;
  • children and adults traveling on vacation or for work to regions with a high incidence of hepatitis A (military personnel, travelers, etc.);
  • children and adults visiting swimming pools;
  • children and adults visiting public catering places (restaurants, cafes);
  • persons contacted in outbreaks;
  • persons at occupational risk of infection: medical personnel and patient care personnel (especially in infectious diseases, gastroenterological and pediatric departments); staff of preschool institutions; sewer and water supply workers; food industry and catering personnel;
  • persons from special risk groups (patients with chronic liver disease or an increased risk of liver disease; patients with hemophilia; patients with multiple blood transfusions; drug addicts; homosexuals; persons who are promiscuous).

Indications for use

The vaccine is used to prevent viral hepatitis A in adults, adolescents and children over 3 years of age.

Indications for use:

  • living in environmentally unfavorable areas where the risk of contracting hepatitis A is increased;
  • planning travel to regions with high incidence rates;
  • travel within the country and abroad;
  • presence of an occupational risk of contracting hepatitis A: medical staff, social workers, specialists who work in preschool and school institutions, workers of water supply and sewerage systems, public catering establishments;
  • entry into a risk group, the presence of chronic liver pathologies, hemophilia, frequent intramuscular and intravenous injections.

Vaccination is also recommended for people who often change sexual partners, use drugs and lead a socially disadvantaged lifestyle.

Instructions for use

Algavac M is used in accordance with special instructions for use. Vaccination is indicated only for healthy people. Before carrying out it, it is necessary to conduct an examination, which includes examination by a specialist, measurement of temperature, pressure, assessment of the condition of the skin and mucous membranes. If necessary, the doctor prescribes certain blood and urine tests.

If you have chronic diseases, additional consultation with specialized specialists is necessary. Allergic patients may suffer from unwanted side reactions in the first days after administration of the drug. To prevent skin itching, inflammation and local swelling, it is necessary to take an antihistamine the day before the procedure.

Vaccination is carried out only in a medical institution, in a specially equipped room where there is a first aid kit for emergency care. The vaccine is administered intramuscularly into the shoulder area. There is no other method of administration provided. The dose for children is 0.5 ml, for adults - 1 ml. Vaccination is carried out in a course, observing a certain interval between administration of the drug.

Main stages of vaccination:

  • studying the external condition of the ampoule, checking the expiration date, batch and other important indicators reflected on the ampoule with the drug;
  • shaking the ampoule;
  • taking the vaccine into a disposable sterile syringe;
  • treating the shoulder muscle with an antiseptic;
  • administration of a vaccine in a certain dose;
  • repeated antiseptic treatment of the injection site.

After vaccination, patients receive detailed advice about possible reactions and their prevention. An opened ampoule can be used within 30 minutes. It is not recommended to rub the injection site so as not to provoke skin inflammation.

Vaccination during pregnancy and breastfeeding

During pregnancy and while breastfeeding, it is prohibited to vaccinate against hepatitis A. If a woman becomes infected during pregnancy, specialists establish medical supervision over her. Jaundice does not threaten the life of the child or the health of the mother. But with a complicated course, the risk of miscarriage and fetal death increases. Therefore, even when planning a pregnancy, it is worth getting vaccinated, especially if the expectant mother is at risk.

It is important to pay increased attention to personal hygiene, thorough hand washing, and treatment of nipples before and after feeding. In this case, vaccination can be carried out during the lactation period.

Use in children

The Algavac M vaccine can be used in cases where the child is already 3 months old. There is no need to get vaccinated before this period, since the newborn receives immunity from the mother. Its effect lasts for approximately 90 days. Pediatricians recommend vaccination before attending kindergarten, where the child will have contact with other children and eat food not prepared at home. Jaundice is difficult for children to tolerate, with clear clinical manifestations. In some children, chronic pathologies of the liver and digestive system progress after the disease.

Contraindications

Only a doctor can decide whether ALGAVAK M is suitable for vaccination

ALGAVAK M is contraindicated if there is a history of an allergic reaction to any component of the vaccine.

Vaccination with ALGAVAK M is contraindicated in the following cases:

  • Acute infectious and non-infectious diseases, exacerbations of chronic diseases. The vaccination is carried out no earlier than 1 month after recovery (remission).
  • Severe reaction (temperature above 40°C; hyperemia, swelling at the injection site with a diameter of more than 8 cm) with the previous administration of the drug.
  • Immunodeficiency conditions, malignant blood diseases and neoplasms.
  • Pregnancy.
  • Hypersensitivity to any component of the vaccine.

Release form and composition

The vaccine is produced in the form of a suspension for intramuscular (IM) administration, slightly opalescent, which, when allowed to settle, is divided into two layers: the upper layer is a colorless transparent liquid, the lower layer is a white sediment, easily broken when shaken, without the presence of foreign inclusions or the formation of flakes [ in ampoules of 0.5 ml (1 pediatric dose) and 1 ml (1 adult dose), in a cardboard pack of 10 ampoules with a “snake” cardboard insert, with or without an ampoule scarifier and instructions for use of Algavac M].

Composition of 1 vaccination dose of suspension:

  • active substance: inactivated hepatitis A virus antigen – at least 160 (dose for children 0.5 ml) or at least 320 (dose for adults 1 ml) ELISA units;
  • auxiliary components: formaldehyde, aluminum hydroxide, phosphate-buffered saline solution 0.01 M (water for injection, sodium chloride, sodium hydrogen phosphate dodecahydrate).

Possible side effects

In isolated cases, vaccinated individuals may experience malaise, headache, and short-term low-grade fever. In rare cases, transient minor soreness or muscle twitching at the site of vaccine administration, as well as slight hyperemia of the skin or mild swelling, which disappear after 1-2 days, are observed.

Considering the theoretical possibility of developing immediate allergic reactions in particularly sensitive individuals, vaccinated individuals must be provided with medical supervision for 30 minutes.

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Algavac M instructions for use

ATX code: J07BC02 (Hepatitis A, inactivated, whole virus) Active substance: hepatitis A vaccine

Dosage form Susp. intramuscular injection of 50 ELISA/ml: 0.5 ml, 1 ml or 2 ml amp. 5 or 10 pcs.

Release form, composition and packaging The suspension for intramuscular administration is slightly opalescent; upon settling, it is divided into two layers: the upper layer is a transparent, colorless liquid, the lower layer is a white sediment, easily broken when shaken, without the formation of flakes and the presence of foreign inclusions. 1 ml - vaccine for the prevention of hepatitis A (inactivated antigen of the hepatitis A virus) 50 ELISA units Excipients: aluminum hydroxide 0.5 mg, formaldehyde no more than 0.15 mg, phosphate-buffered saline solution 0.01 M up to 1 ml.

Clinical and pharmacological group: Vaccine for the prevention of hepatitis A

Pharmacotherapeutic group: MIBP vaccine

Indications Active prevention of viral hepatitis A in children aged 3 years, adolescents and adults. Persons who are or will be at risk of contracting viral hepatitis A are subject to vaccination: - persons living in areas with a high incidence of hepatitis A; — persons traveling to regions with a high incidence of hepatitis A (military personnel, travelers, etc.); — persons contacted in outbreaks; — persons at occupational risk of infection: medical personnel and patient care personnel (especially in infectious diseases, gastroenterological and pediatric departments); staff of preschool institutions; sewer and water supply workers; food industry and catering personnel; - persons from special risk groups (patients with chronic liver disease or an increased risk of liver disease; patients with hemophilia; patients with multiple blood transfusions; drug addicts; homosexuals; people who are promiscuous). Vaccinations may also be given to other groups of the population.

Dosage regimen The vaccine is administered intramuscularly into the deltoid muscle (shoulder muscle). One vaccination dose is: for children and adolescents - 0.5 ml, for adults - 1.0 ml. The vaccination course, which provides long-term protection against hepatitis A, consists of two vaccinations given at intervals of 6-12 months. A single injection of the vaccine provides protection against infection for up to 12 months. Intravenous administration of the vaccine is not allowed! The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antiseptics. Before inserting into the syringe, the vaccine is thoroughly mixed by shaking the ampoule. When using a multi-dose ampoule, each dose should be administered using a separate sterile syringe with a sterile needle. The vaccine from an opened multi-dose ampoule must be used within 30 minutes. The drug is not suitable for use in ampoules with damaged integrity, markings, or changes in physical properties (color, transparency, etc.). Vaccinations performed are recorded in established registration forms indicating the date, dose, manufacturer, batch number, reaction to vaccination.

Side effects In isolated cases, vaccinated individuals may experience malaise, headache, and short-term low-grade fever. In rare cases, transient minor soreness or muscle twitching at the site of vaccine administration, as well as slight hyperemia of the skin or mild swelling, which disappear after 1-2 days, are observed. Considering the theoretical possibility of developing immediate allergic reactions in particularly sensitive individuals, vaccinated individuals must be provided with medical supervision for 30 minutes. Vaccination sites must be provided with anti-shock therapy.

Contraindications for use : acute infectious and non-infectious diseases, exacerbations of chronic diseases. Vaccination is carried out no earlier than 1 month after recovery (remission); - severe reaction (temperature above 40°C; hyperemia, swelling at the injection site with a diameter of more than 8 cm) with the previous administration of the drug; — immunodeficiency conditions, malignant blood diseases and neoplasms; - pregnancy; - hypersensitivity to any component of the vaccine. In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts an examination and questioning of the vaccinated person with mandatory thermometry. If necessary, carry out appropriate laboratory testing.

Use during pregnancy and breastfeeding Contraindicated during pregnancy.

Use in children Children over 3 years of age are subject to vaccination.

Drug interactions The simultaneous (on the same day) use of Algvak M with other inactivated vaccines of the national calendar of preventive vaccinations and the calendar of preventive vaccinations for epidemic indications (with the exception of rabies vaccine) is allowed, provided that the vaccines are administered to different parts of the body. The vaccine cannot be mixed in the same syringe with other vaccines.

Storage conditions and periods The vaccine is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2°C to 8°C. Do not freeze. Keep out of the reach of children. Shelf life: 2 years.

Conditions for dispensing from pharmacies For medical and preventive and sanitary institutions.

special instructions

Algavac M does not protect against other infectious liver diseases and viral hepatitis B, C, E.

To identify contraindications to vaccination, on the day of vaccination, the doctor conducts a survey and examination of the vaccinated person with mandatory thermometry.

Anti-shock therapy must be provided in the vaccination room.

Within 30 minutes after vaccination with Algavac M, the vaccinee should be under medical supervision due to the theoretical possibility of developing immediate allergic reactions in particularly sensitive patients.

Algavac M can be used for revaccination of persons who received previous immunization with another inactivated vaccine for the prevention of hepatitis A.

Administration of the vaccine during the incubation period of hepatitis A disease may not be effective enough.

A weak immune response to the drug may be observed in HIV-infected people and persons receiving treatment with immunosuppressants or immunostimulants.

Impact on the ability to drive vehicles and complex mechanisms

Algavac M does not have a negative effect on the ability to perform activities that require quick reactions and increased attention, including driving a car and working with moving mechanisms.

Side effects

Algavac M is generally well tolerated (it is slightly reactogenic).

Possible adverse reactions reported in clinical and post-marketing studies:

  • very often (> 10%): pain and redness of the skin at the injection site;
  • often (from > 1% to < 10%): fever more than 37 ° C, dizziness, headache, mild infiltration at the injection site;
  • very rare (<0.01%): muscle twitching at the injection site.

All adverse events that occurred were short-term (no more than 24 hours) and did not require special treatment.

Drug interactions

Algavac M suspension cannot be mixed in the same syringe with other drugs/vaccines.

If necessary, Algavac M can be administered on the same day or with an interval of 1 month with other inactivated vaccines provided for by the National Preventive Vaccination Calendar and the Preventive Vaccination Calendar for epidemic indications, with the exception of rabies vaccine. When administered on the same day, separate syringes should be used and vaccinations should be given to different areas of the body.

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