Dacarbazine for Injection USP 100mg (Onivdryl) Technical Specification:
| Product Name: | Dacarbazine for Injection USP 100mg |
| Brand Name: | Onivdryl |
| Strength: | 100mg, 200mg, 500mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| 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: | Dacarbazine is used to treat cancer of the lymph system and malignant melanoma (a type of skin cancer). It may also be used to treat other kinds of cancer, as determined by your doctor. Dacarbazine interferes with the growth of cancer cells, which are eventually destroyed. |
| Storage: | Store the vials in the original carton between 2°C to 8°C (36° to 46° F). Do not freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Dacarbazine for Injection USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Dacarbazine for Injection USP 100mg
Each sterile lyophilized vial contains:
Dacarbazine USP…………………100mg
Excipients:
Anhydrous Citric Acid USP…..q.s.
Mannitol USP………………………q.s.
Water for Injection USP………q.s.
THERAPEUTIC INDICATION:
Dacarbazine is used to treat cancer of the lymph system and malignant melanoma (a type of skin cancer). It may also be used to treat other kinds of cancer, as determined by your doctor. Dacarbazine interferes with the growth of cancer cells, which are eventually destroyed.
DIRECTION OF USE:
For Intravenous use only.
Reconstitution for 100mg: Reconstitute with 9.9 ml of Sterile Water for Injection USP to get a concentration of 10mg/ml of Dacarbazine.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Use within 8 hours of Reconstitution.
Prepared as the citrate salt.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store the vials in the original carton between 2°C to 8°C (36° to 46° F).
Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Dacarbazine for Injection USP 100mg
b) Dacarbazine for Injection USP 200mg
c) Dacarbazine for Injection USP 500mg
b) Dacarbazine for Injection USP 200mg
c) Dacarbazine for Injection USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Dacarbazine for Injection USP 100mg
Each sterile lyophilized vial contains:
Dacarbazine USP…………………100mg
Excipients:
Anhydrous Citric Acid USP…..q.s.
Mannitol USP………………………q.s.
Water for Injection USP………q.s.
b) Dacarbazine for Injection USP 200mg
Each sterile lyophilized vial contains:
Dacarbazine USP………………….200mg
Excipients:
Anhydrous Citric Acid USP…..q.s.
Mannitol USP……………….……..q.s.
Water for Injection USP……….q.s.
c) Dacarbazine for Injection USP 500mg
Each sterile lyophilized vial contains:
Dacarbazine USP………………….500mg
Excipients:
Anhydrous Citric Acid USP……q.s.
Mannitol USP……………………….q.s.
Water for Injection USP……….q.s.
Each sterile lyophilized vial contains:
Dacarbazine USP…………………100mg
Excipients:
Anhydrous Citric Acid USP…..q.s.
Mannitol USP………………………q.s.
Water for Injection USP………q.s.
b) Dacarbazine for Injection USP 200mg
Each sterile lyophilized vial contains:
Dacarbazine USP………………….200mg
Excipients:
Anhydrous Citric Acid USP…..q.s.
Mannitol USP……………….……..q.s.
Water for Injection USP……….q.s.
c) Dacarbazine for Injection USP 500mg
Each sterile lyophilized vial contains:
Dacarbazine USP………………….500mg
Excipients:
Anhydrous Citric Acid USP……q.s.
Mannitol USP……………………….q.s.
Water for Injection USP……….q.s.
THERAPEUTIC INDICATION:
Dacarbazine is used to treat cancer of the lymph system and malignant melanoma (a type of skin cancer). It may also be used to treat other kinds of cancer, as determined by your doctor. Dacarbazine interferes with the growth of cancer cells, which are eventually destroyed.
DIRECTION OF USE:
For Intravenous use only.
Reconstitution for 100mg: Reconstitute with 9.9 ml of Sterile Water for Injection USP to get a concentration of 10mg/ml of Dacarbazine.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
Reconstitution for 100mg: Reconstitute with 9.9 ml of Sterile Water for Injection USP to get a concentration of 10mg/ml of Dacarbazine.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Use within 8 hours of Reconstitution. Prepared as the citrate salt.
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.
NOTE: Use within 8 hours of Reconstitution. Prepared as the citrate salt.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store the vials in the original carton between 2°C to 8°C (36° to 46° F).
Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.
Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.
