Immunoglobulin variole human (Solution) Instructions for Use
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
ATC Code
J06BB07 (Vaccine immunoglobulin)
Active Substance
Human antismallpox immunoglobulin (Grouping name)
Dosage Form
 |
Human antismallpox immunoglobulin | Solution for intramuscular injection 1.5 ml/1 dose: amp. 1 dose, 2 doses |
Dosage Form, Packaging, and Composition
| Solution for intramuscular injection | 1 dose |
| Antibodies to orthopoxviruses | 1.5 ml |
| In a titer not less than 1:4000 |
1 dose – ampoules (10) – carton packs.
2 doses – ampoules (10) – carton packs.
Clinical-Pharmacological Group
Immunological preparation. Immunoglobulin
Pharmacotherapeutic Group
Immune sera and immunoglobulins; immunoglobulins; specific immunoglobulins
Pharmacological Action
The active principle of the drug is the antibodies contained in the immunoglobulin, which possess specific activity against orthopoxviruses.
Prevention and treatment of complications of the vaccinal process in those vaccinated against smallpox; treatment and prevention of smallpox.
Indications
- Prevention and treatment of post-vaccination complications in children from the first days of life and adults following administration of the live smallpox vaccine: generalization of the vaccinal process, post-vaccinal encephalitis and other complications;
- Emergency prevention and treatment of smallpox in children from the first days of life and adults.
ICD codes
| ICD-10 code | Indication |
| B03 | Smallpox |
| T88 | Other complications of surgical and medical care, not elsewhere classified |
| Z29.1 | Prophylactic immunotherapy (administration of immunoglobulin) |
| ICD-11 code | Indication |
| 1E70 | Smallpox |
| NE8Z | Injury or harm caused as a result of surgical or therapeutic interventions, not elsewhere classified, unspecified |
| QC05.1 | Prophylactic immunotherapy |
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. |
The immunoglobulin is administered intramuscularly.
For prevention of post-vaccination complications, the drug is administered to primarily vaccinated children as a single dose of 1.5 ml, and to adults – 3 ml immediately before vaccination.
For emergency prevention of smallpox, the drug is administered as a single dose of 3 ml.
For treatment of post-vaccination complications, as well as for treatment of smallpox, the immunoglobulin is administered at a dose of 0.5-1 ml per kg of body weight depending on the severity of the clinical course of the disease. This dose can be administered in one go or divided into several injections per day. The duration of the treatment course is determined by the attending physician.
It is prohibited to administer the drug intravenously.
Before injection, the ampoule with the drug is kept for 2 hours at room temperature. Opening of the ampoules and the administration procedure are carried out with strict adherence to the rules of asepsis and antisepsis. To avoid foam formation, the drug is drawn into the syringe with a needle having a wide lumen.
The drug in an opened ampoule must not be stored. The drug is unsuitable for use in ampoules with damaged integrity or labeling, if physical properties have changed (color change, solution turbidity, presence of non-dispersible flakes), if the expiration date has passed, or if storage conditions have been violated.
The administration of the immunoglobulin is recorded in the established accounting forms, indicating the batch number, manufacturing date, expiration date, manufacturer, date of administration, and the nature of the reaction to the drug administration.
Adverse Reactions
Adverse effects of the immunoglobulin are generally absent.
In rare cases, local reactions may develop in the form of hyperemia and an increase in temperature to 37.5°C (99.5°F) during the first 2 days after administration. In some individuals with altered reactivity, allergic reactions of various types may develop, and in extremely rare cases, anaphylactic shock may occur. In this regard, persons who have received the drug should be under medical supervision for 30 minutes.
Vaccination sites must be equipped with means for anti-shock therapy.
Contraindications
- Severe allergic reactions to the administration of human blood products in the medical history;
- Allergic diseases;
- Presence of clinically significant allergic reactions in the medical history.
On the day of immunoglobulin administration and for the next 8 days, the prescription of antihistamines is recommended.
Use in Pregnancy and Lactation
The safety of use during pregnancy has not been studied in clinical trials.
During breastfeeding, it is used for vital indications if the expected benefit for the mother outweighs the potential risk for the breastfed infant.
Pediatric Use
Used in children from the first days of life.
Drug Interactions
Smallpox immunoglobulin can be used with the smallpox vaccine for the prevention of post-vaccination complications.
Interactions with other medicinal products have not been established.
Storage Conditions
The drug is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature from 2°C (35.6°F) to 8°C (46.4°F) in a place inaccessible to children. Freezing is not allowed.
Shelf Life
The shelf life of the drug is 2 years. The drug must not be used after the expiration date.
Dispensing Status
For medical and preventive institutions.
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![Immunoglobulin variole human [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Immunoglobulin variole human [Solution] 2")