a) Doxorubicin Hydrochloride for Injection USP 10mg
b) Doxorubicin Hydrochloride for Injection USP 20mg
c) Doxorubicin Hydrochloride for Injection USP 50mg
d) Doxorubicin Hydrochloride for Injection USP 150mg
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- Doxorubicin Hydrochloride for Injection USP 10mg (Humadrain)
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
- Doxorubicin Hydrochloride for Injection USP 10mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Doxorubicin Hydrochloride for Injection USP 10mg
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP……10mg
Mannitol USP……………………………….60mg
Lactose Monohydrate USNF…………50mg
Methyl Paraben USNF………………….2mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
b) Doxorubicin Hydrochloride for Injection USP 20mg
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP……20mg
Mannitol USP……………………………….120mg
Lactose Monohydrate USNF…………100mg
Methyl Paraben USNF………………….4mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
c) Doxorubicin Hydrochloride for Injection USP 50mg
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP…...50mg
Mannitol USP……………………………….300mg
Lactose Monohydrate USNF…………250mg
Methyl Paraben USNF………………….20mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
d) Doxorubicin Hydrochloride for Injection USP 150mg
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP…...150mg
Mannitol USP……………………………….900mg
Lactose Monohydrate USNF…………750mg
Methyl Paraben USNF………………….30mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP……10mg
Mannitol USP……………………………….60mg
Lactose Monohydrate USNF…………50mg
Methyl Paraben USNF………………….2mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
b) Doxorubicin Hydrochloride for Injection USP 20mg
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP……20mg
Mannitol USP……………………………….120mg
Lactose Monohydrate USNF…………100mg
Methyl Paraben USNF………………….4mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
c) Doxorubicin Hydrochloride for Injection USP 50mg
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP…...50mg
Mannitol USP……………………………….300mg
Lactose Monohydrate USNF…………250mg
Methyl Paraben USNF………………….20mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
d) Doxorubicin Hydrochloride for Injection USP 150mg
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP…...150mg
Mannitol USP……………………………….900mg
Lactose Monohydrate USNF…………750mg
Methyl Paraben USNF………………….30mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
THERAPEUTIC INDICATION:
Doxorubicin Hydrochloride is used in treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms' tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin's disease, malignant lymphoma and bronchogenic carcinoma.
DIRECTION OF USE:
For Intravenous use only.
Reconstitution for 10mg: Reconstitute with 5ml 0.9% sodium chloride injection. After reconstitution the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C. Discard unused portion.
Read accompanying leaflet for detailed dosage, directions of use and precautions.
Reconstitution for 10mg: Reconstitute with 5ml 0.9% sodium chloride injection. After reconstitution the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C. Discard unused portion.
Read accompanying leaflet for detailed dosage, directions of use and precautions.
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.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of Cancer Specialist only.
CAUTION: Cytotoxic agent – Special Handling.
This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Use immediately after preparation.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
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.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of Cancer Specialist only.
CAUTION: Cytotoxic agent – Special Handling.
This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Use immediately after preparation.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
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 the physician.
Dosage: As directed by the physician.
Doxorubicin Hydrochloride for Injection USP 10mg Technical Specification:
| Product Name: | Doxorubicin Hydrochloride for Injection USP 10mg |
| Brand Name: | Humadrain |
| Strength: | 10mg, 20mg, 50mg, 150mg |
| Dosage Form: | Dry Powder Injection (Lyophilized) |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For I.V. 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: | Doxorubicin Hydrochloride is used in treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma. |
| Storage: | Store between 2°C to 8°C in a refrigerator. Do not freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Doxorubicin Hydrochloride for Injection USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Doxorubicin Hydrochloride for Injection USP 10mg
Each sterile lyophilized vial contains:
Doxorubicin Hydrochloride USP……10mg
Mannitol USP……………………………….60mg
Lactose Monohydrate USNF…………50mg
Methyl Paraben USNF………………….2mg
Sodium Hydroxide USNF………………q.s.
Hydrochloric Acid USNF………………q.s.
THERAPEUTIC INDICATION:
Doxorubicin Hydrochloride is used in treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma.
DIRECTION OF USE:
For Intravenous use only.
Reconstitution for 10mg: Reconstitute with 5ml 0.9% sodium chloride injection. After reconstitution the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C. Discard unused portion.
Read accompanying leaflet for detailed dosage, directions of use and precautions.
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.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of Cancer Specialist only.
CAUTION: Cytotoxic agent – Special Handling.
This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Use immediately after preparation.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
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 the physician.
