Daunorubicin Hydrochloride for Injection USP 20mg (Oxirvera) Technical Specification:
| Product Name: | Daunorubicin Hydrochloride for Injection USP 20mg |
| Brand Name: | Oxirvera |
| Strength: | 20mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For I.V. infusion 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: | Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi’s sarcoma. |
| Storage: | Store between 2°C to 8°C in a refrigerator. Do not freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Daunorubicin Hydrochloride for Injection USP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Daunorubicin Hydrochloride for Injection USP 20 mg
Each vial contains:
Daunorubicin hydrochloride USP Equivalent to
Daunorubicin……………………20 mg
Excipients…………………………q.s.
THERAPEUTIC INDICATION:
Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi’s sarcoma.
DIRECTION OF USE:
For Intravenous infusion only.
As sterile, freeze-dried powder for reconstitution with Sodium Chloride Injection USP 10ml. Use immediately after reconstitution.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
This is potent Cytotoxic agent, use only after reading the directions on the pack insert.
Discard Unused portion.
Cytotoxic Agent – Special Handling
Keep the pack upright, Handle with care.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store between 2°C to 8°C in a refrigerator.
Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Daunorubicin Hydrochloride for Injection USP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Daunorubicin Hydrochloride for Injection USP 20 mg
Each vial contains:
Daunorubicin hydrochloride USP Equivalent to
Daunorubicin……………………20 mg
Excipients…………………………q.s.
Each vial contains:
Daunorubicin hydrochloride USP Equivalent to
Daunorubicin……………………20 mg
Excipients…………………………q.s.
THERAPEUTIC INDICATION:
Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi's sarcoma.
DIRECTION OF USE:
For Intravenous infusion only.
As sterile, freeze-dried powder for reconstitution with Sodium Chloride Injection USP 10ml. Use immediately after reconstitution.
As sterile, freeze-dried powder for reconstitution with Sodium Chloride Injection USP 10ml. Use immediately after reconstitution.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
This is potent Cytotoxic agent, use only after reading the directions on the pack insert. Discard Unused portion.
Cytotoxic Agent – Special Handling
Keep the pack upright, Handle with care.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
This is potent Cytotoxic agent, use only after reading the directions on the pack insert. Discard Unused portion.
Cytotoxic Agent – Special Handling
Keep the pack upright, Handle with care.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store between 2°C to 8°C in a refrigerator.
Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.
Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.
