GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each Lyophilized Vial Contains:
Remdesivir ...............................100mg
Excipients ............................... Q.S.
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
After reconstitution, vials can be stored up to 4 hours at room temperature prior to administration or 24 hours at refrigerated temperature.
Dilute within same day as administration or Use immediately after dissolving the contents.
REFER ACCOMPANYING PACKAGE INSERT FOR DETAILED DOSAGE, DIRECTIONS FOR USE AND PRECAUTIONS.
CAUTION & WARNING:
Keep out of reach and sight of children.
Do not reuse or save unused Remdesivir lyophilized powder or diluted solution for infusion for future use.
If any foreign particle is visible after dissolving the contents, Please do not use the solution.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Store diluted remdesivir solution for infusion up to 24 hours at below 25°C or 48 hours in a refrigerator (2°C – 8°C).
REFER ACCOMPANYING PACKAGE INSERT FOR DETAIL STORAGE CONDITION.
Dosage: As directed by the Physician.
Remdesivir for Injection 100mg/vial Technical Specification:
| Product Name: | Remdesivir For Injection |
| Brand Name: | Remdetaj |
| Strength: | 100mg/vial |
| Dosage Form: | Lyophilized Powder for Injection (Sterile) |
| Packing: | 1 Single Dose Vial + WFI Tray |
| Route of Administration: | For I.V. use only |
| Pack Insert/Leaflet: | Covid Use Leaflet, PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiviral & used to treat coronavirus (COVID-19) |
| Indication: | Remdesivir for Injection (Remdetaj) is an antiviral medicine used for treating COVID-19. COVID-19 is caused by a virus called a coronavirus. Remdesivir Injection stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster. |
| Storage: | Store below 30°C (86°F). After reconstituted vial can be stored up to 4 hours at room temperature (20°C to 25°C [68°F to 77°F]). Store diluted remdesivir solution for infusion up to 24 hours at below 25°C or 48 hours in a refrigerator (2°C – 8°C). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Remdesivir For Injection 100mg/vial (Remdetaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Remdesivir For Injection 100mg/vial
Composition:
Each Lyophilized Vial Contains:
Remdesivir ………………………….100mg
Excipients …………………………. q.s
THERAPEUTIC INDICATIONS:
Remdesivir for Injection (Remdetaj) is an antiviral medicine used for treating COVID-19. COVID-19 is caused by a virus called a coronavirus. Remdesivir Injection stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster.
DIRECTION OF USE:
Remdesivir must be reconstituted with 19 mL sterile water for injection IP to get 5mg/ml of remdesivir solution. The reconstituted solution should be further diluted in sodium chloride 9 mg/mL (0.9%) saline solution for injection preferred total volume 100ml before being administered via intravenous infusion over 30 to 120 minutes.
After reconstitution, vials can be stored up to 4 hours at room temperature prior to administration or 24 hours at refrigerated temperature.
Dilute within same day as administration or Use immediately after dissolving the contents.
REFER ACCOMPANYING PACKAGE INSERT FOR DETAILED DOSAGE, DIRECTIONS FOR USE AND PRECAUTIONS.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
Keep out of reach and sight of children.
Do not reuse or save unused Remdesivir lyophilized powder or diluted solution for infusion for future use.
If any foreign particle is visible after dissolving the contents, Please do not use the solution.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 30°C (86°F). After reconstituted vial can be stored up to 4 hours at room temperature (20°C to 25°C [68°F to 77°F]).
Store diluted remdesivir solution for infusion up to 24 hours at below 25°C or 48 hours in a refrigerator (2°C – 8°C).
REFER ACCOMPANYING PACKAGE INSERT FOR DETAIL STORAGE CONDITION.
Dosage: As directed by the Physician.
NOTE:
- Before administration of the injection to the patient, it is the responsibility of the treating physician/ institution to administer informed consent form (ICF) as prescribed, CDSCO approved format included inside the carton.
- POM Schedule 2 PP
