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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for intramuscular injection 0.5 ml/1 dose: vial 2 pcs.
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
 |
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.
Lyophilisate for the preparation of solution for intramuscular administration: vial
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
|
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.
Solution for intramuscular injection 0.5 ml+0.5 ml/1 dose: vial 2 pcs.
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
|
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.
![GamEvac [Solution, Lyophilisate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "GamEvac [Solution, Lyophilisate] 2")