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GamEvac (Solution, Lyophilisate) Instructions for Use

ATC Code

J07B (Viral vaccines)

Active Substance

Vaccine for prevention of Ebola virus disease (Grouping name)

Clinical-Pharmacological Group

Vaccine for the prevention of Ebola fever

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Drugs containing this vaccine induce the formation of humoral and cellular immunity against Ebola hemorrhagic fever and provide a protective level of specific antibodies.

Indications

  • Prevention of Ebola fever in adults.

ICD codes

ICD-10 code Indication
Z25.8 Need for immunization against other specified single viral diseases
ICD-11 code Indication
QC01.Z Need for immunization against a single specified viral disease, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the vaccine as a two-dose primary series. Observe an interval of 21 to 28 days between the first and second dose.

The route of administration is either intramuscular or subcutaneous, depending on the specific dosage form used. Do not interchange different drug products containing this vaccine.

Always consult the full prescribing information for the specific drug product before preparation and administration.

Adverse Reactions

Common general reactions include a short-term flu-like syndrome with chills, fever, arthralgia, myalgia, asthenia, malaise, and headache. Allergic reactions and transient increases in serum CPK and creatinine may occur.

Local reactions typically involve swelling and redness at the injection site. Gastrointestinal effects include nausea, loss of appetite, and elevated liver transaminases.

Drug Interactions

Concomitant administration with immunosuppressive therapy may diminish the immune response to the vaccine.

Avoid concurrent administration with other inactivated or live vaccines; if necessary, administer at different injection sites. Inform the healthcare provider about all concomitant medications, including over-the-counter drugs and herbal products.

Contraindications

  • Hypersensitivity to any component of the vaccine or a history of severe allergic reaction to a previous dose.
  • Acute febrile illnesses or exacerbations of chronic diseases.
  • Acute allergic conditions.
  • Malignant blood diseases and neoplasms.
  • Pregnancy and breastfeeding.
  • Use in children and adolescents under 18 years of age.

Overdose

No specific antidote for overdose is known. Management should consist of symptomatic and supportive care.

Monitor for an exaggeration of known adverse reactions, particularly severe flu-like symptoms or pronounced local reactions. Report suspected overdose to a poison control center.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

Use with caution in chronic diseases of the liver and kidneys, diseases of the endocrine system (including severe thyroid dysfunction, diabetes mellitus), severe diseases of the hematopoietic system, in diseases of the central nervous system (including epilepsy), history of myocardial infarction, myocarditis, endocarditis, pericarditis, in coronary artery disease.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

FSBI N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation (Medgamal Branch of the N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation) (Russia)

Dosage Form

Bottle Rx Icon GamEvac Vector vaccine against Ebola Solution for intramuscular injection 0.5 ml/1 dose: vial 2 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection in the form of a column of frozen homogeneous liquid with a horizontal meniscus, upon thawing – a homogeneous, colorless or with a yellowish tint, slightly opalescent solution.

1 vial (0.5 ml)
Mixture (1:1) of recombinant pseudo-adenoviral particles expressing the GP gene of the Ebola virus, and recombinant pseudo-adenoviral particles expressing the NP gene of the Ebola virus, (in total quantity) (2.5±1.5)×1011

The number of active recombinant pseudo-adenoviral particles expressing the GP gene of the Ebola virus is (2.5±1.5)×108 active units/dose; the number of active recombinant pseudo-adenoviral particles expressing the NP gene of the Ebola virus is (2.5±1.5)×108 active units/dose. (The number of active recombinant pseudo-adenoviral particles is determined in the mono-intermediates of the drug before adding the buffer solution).

Excipients : tris(hydroxymethyl)aminomethane – 1.211 mg, sodium chloride – 4.38 mg, sucrose – 25 mg, polysorbate 80 – 0.0005 ml, magnesium chloride hexahydrate – 0.203 mg, ethanol 95% – 0.005 ml, edetate disodium – 0.0373 mg, water for injection – up to 0.5 ml.

0.5 ml (1 dose) – glass vials (2) – cardboard packs.

Marketing Authorization Holder

FSBI N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation (Medgamal Branch of the N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation) (Russia)

Dosage Form

Bottle Rx Icon GamEvac-Lio Ebola Combination Vector Vaccine Lyophilisate for the preparation of solution for intramuscular administration: vial

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of solution for intramuscular injection
Vaccine for prevention of Ebola virus disease

Glass vials – cardboard packs.

Marketing Authorization Holder

FSBI N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation (Medgamal Branch of the N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation) (Russia)

Dosage Form

Bottle Rx Icon GamEvac-Combi Combination vector vaccine against Ebola Solution for intramuscular injection 0.5 ml+0.5 ml/1 dose: vial 2 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection in the form of a column of frozen homogeneous liquid with a horizontal meniscus, upon thawing – a homogeneous, colorless or with a yellowish tint, slightly opalescent solution.

Component A

1 vial (0.5 ml)
Recombinant particles based on vesicular stomatitis virus, expressing the GP gene of the Ebola virus (2.5±1.5)×107 active units

Excipients : tris(hydroxymethyl)aminomethane – 0.605 mg, edetate disodium – 0.168 mg, sucrose – 50 mg, water for injection – up to 0.5 ml.

Component B

1 vial (0.5 ml)
Recombinant pseudo-adenoviral particles expressing the GP gene of the Ebola virus* (2.5±1.25)×1011

* The number of active recombinant pseudo-adenoviral particles expressing the GP gene of the Ebola virus is (4.5±2.5)×108 active units/dose.

Excipients : tris(hydroxymethyl)aminomethane – 1.211 mg, sodium chloride – 4.38 mg, sucrose – 25 mg, polysorbate 80 – 0.0005 ml, magnesium chloride hexahydrate – 0.203 mg, ethanol 95% – 0.005 ml, edetate disodium – 0.0373 mg, water for injection – up to 0.5 ml.

0.5 ml (1 dose of component A in 1 vial) + 0.5 ml (1 dose of component B in 1 vial) – glass vials (2) – cardboard packs.

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