Azacitidine for Injection 150mg Technical Specification:
| Product Name: | Azacitidine for Injection 150mg |
| Brand Name: | Dessraunt |
| Strength: | 50mg, 100mg, 150mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For Subcutaneous, Intravenous use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Cancer |
| Indication: | Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia. |
| Storage: | Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Azacitidine for Injection 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Azacitidine for Injection 150mg
Each vial contains:
Azacitidine……………………150mg
(as Lyophillized powder)
Excipients……………………..q.s.
THERAPEUTIC INDICATION:
Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia.
DIRECTION OF USE:
For Subcutaneous, Intravenous use only
Use sterile water for Injections IP for subcutaneous & for intravenous use.
See prescribing information for dosing and administration.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
CYTOTOXIC AGENT: Handle with care
Lyophilized Injection, should reconstitute prior to administration.
Use the solution with in 8 hours of opening. Discard unused solution, if stored 2-8°C
Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Protect from light.
Do not freeze.
Dosage: As directed by an Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Azacitidine for Injection 50mg
b) Azacitidine for Injection 100mg
c) Azacitidine for Injection 150mg
b) Azacitidine for Injection 100mg
c) Azacitidine for Injection 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Azacitidine for Injection 50mg
Each vial contains:
Azacitidine……………………50mg
(as Lyophillized powder)
Excipients……………………..q.s.
b) Azacitidine for Injection 100mg
Each vial contains:
Azacitidine……………………100mg
(as Lyophillized powder)
Excipients……………………..q.s.
c) Azacitidine for Injection 150mg
Each vial contains:
Azacitidine…………………….150mg
(as Lyophillized powder)
Excipients………………………q.s.
Each vial contains:
Azacitidine……………………50mg
(as Lyophillized powder)
Excipients……………………..q.s.
b) Azacitidine for Injection 100mg
Each vial contains:
Azacitidine……………………100mg
(as Lyophillized powder)
Excipients……………………..q.s.
c) Azacitidine for Injection 150mg
Each vial contains:
Azacitidine…………………….150mg
(as Lyophillized powder)
Excipients………………………q.s.
THERAPEUTIC INDICATION:
Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia.
DIRECTION OF USE:
For Subcutaneous, Intravenous use only
Use sterile water for Injections IP for subcutaneous & for intravenous use.
See prescribing information for dosing and administration.
Use sterile water for Injections IP for subcutaneous & for intravenous use.
See prescribing information for dosing and administration.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
CYTOTOXIC AGENT: Handle with care
Lyophilized Injection, should reconstitute prior to administration.
Use the solution with in 8 hours of opening. Discard unused solution, if stored 2-8°C
Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Discard Unused portion.
Keep out of the reach of the children.
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
CYTOTOXIC AGENT: Handle with care
Lyophilized Injection, should reconstitute prior to administration.
Use the solution with in 8 hours of opening. Discard unused solution, if stored 2-8°C
Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Protect from light.
Do not freeze.
Dosage: As directed by an Oncologist.
Protect from light.
Do not freeze.
Dosage: As directed by an Oncologist.
