Oxaliplatin for Injection USP 50mg (Voxatin) Technical Specification:
| Product Name: | Oxaliplatin for Injection USP 50mg |
| Brand Name: | Voxatin |
| Strength: | 50mg, 100mg |
| 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: | Oxaliplatin is also used with other medications to prevent colon cancer from spreading in people who have had surgery to remove the tumor. It works by killing cancer cells. |
| Storage: | Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Oxaliplatin for Injection USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Oxaliplatin for Injection USP 50mg
Each vial contains:
Oxaliplatin USP……………………50mg
Lactose monohydrate NF……450mg
THERAPEUTIC INDICATION:
Oxaliplatin is also used with other medications to prevent colon cancer from spreading in people who have had surgery to remove the tumor. It works by killing cancer cells.
DIRECTION OF USE:
For Intravenous Use only.
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. Fatal if given Intrathecally for Intravenous use only.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Oxaliplatin for Injection should not be administered with needles or intravenous sets containing aluminum components.
Do not reconstitute with Sodium Chloride/ Chloride containing solution.
REFRIGERATED PRODUCT
Preservative Free
Must be reconstituted and diluted before use
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dosage: As directed by an Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Oxaliplatin for Injection USP 50mg
b) Oxaliplatin for Injection USP 100mg
b) Oxaliplatin for Injection USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Oxaliplatin for Injection USP 50mg
Each vial contains:
Oxaliplatin USP……………………50mg
Lactose monohydrate NF……450mg
b) Oxaliplatin for Injection USP 100mg
Each vial contains:
Oxaliplatin USP……………………100mg
Lactose monohydrate NF…….900mg
Each vial contains:
Oxaliplatin USP……………………50mg
Lactose monohydrate NF……450mg
b) Oxaliplatin for Injection USP 100mg
Each vial contains:
Oxaliplatin USP……………………100mg
Lactose monohydrate NF…….900mg
THERAPEUTIC INDICATION:
Oxaliplatin is also used with other medications to prevent colon cancer from spreading in people who have had surgery to remove the tumor. It works by killing cancer cells.
DIRECTION OF USE:
For Intravenous Use only.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
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. Fatal if given Intrathecally for Intravenous use only.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Oxaliplatin for Injection should not be administered with needles or intravenous sets containing aluminum components.
Do not reconstitute with Sodium Chloride/ Chloride containing solution.
REFRIGERATED PRODUCT
Preservative Free
Must be reconstituted and diluted before use
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Oxaliplatin for Injection should not be administered with needles or intravenous sets containing aluminum components.
Do not reconstitute with Sodium Chloride/ Chloride containing solution.
REFRIGERATED PRODUCT
Preservative Free
Must be reconstituted and diluted before use
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dosage: As directed by an Oncologist.
Dosage: As directed by an Oncologist.
