a) Oxaliplatin Injection USP 50mg
b) Oxaliplatin Injection USP 100mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Oxaliplatin Injection USP 50mg
Each vial contains:
Oxaliplatin USP……………………50mg
Lactose monohydrate NF……450mg
b) Oxaliplatin 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 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.
Oxaliplatin Injection USP (100mg) Technical Specification:
| Product Name: | Oxaliplatin Injection USP 100mg |
| Brand Name: | Generic |
| Strength: | (50mg/10), (100mg/20ml) |
| Dosage Form: | Liquid 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 Injection USP 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]. |
Oxaliplatin Injection USP 100mg Manufacturers, Suppliers in India:
Taj Pharmaceuticals is of the prominent Oxaliplatin Injection USP 100mg Manufacturers in India that brings the best quality products. Our company Taj Pharma carries a rich experience in the niche manufacturing of Oxaliplatin Injection USP 100mg.
Taj Pharmaceuticals is a reputed manufacturer and Oxaliplatin Injection USP 100mg Suppliers in India prefer Taj Pharma is best known for its products’ topmost standards and consistent quality.
Taj Pharma is a well-known Oxaliplatin Injection USP 100mg in India that gives the assurance of high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.
Oxaliplatin Injection USP 100mg manufactured at Taj Pharma. the product is manufactured to comply with good quality standards which are considered the Best in the world. Further, Taj Pharma uses Oxaliplatin Injection USP 100mg grade best active ingredient to manufacture its Injections to comply with international standards of European products.
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Oxaliplatin Injection USP 50mg
- Oxaliplatin Injection USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Oxaliplatin Injection USP 50mg
Each vial contains:
Oxaliplatin USP……………………50mg
Lactose monohydrate NF……450mg - Oxaliplatin Injection USP 100mg
Each vial contains:
Oxaliplatin USP……………………100mg
Lactose monohydrate NF…….900mg
THERAPEUTIC INDICATION:
Oxaliplatin Injection is also used with other medications to prevent colon cancer from spreading in people who have had surgery to remove the tumour. 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 package insert.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
NOTE: Oxaliplatin liquid Injection should not be administered with needles or intravenous sets containing aluminium 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 the 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.
Oxaliplatin Injection USP 100mg Exporters; We can cater to export business queries from the following geographies. We are exporting our Oxaliplatin Injection USP 100mg product in Following Countries:
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Oxaliplatin Injection USP 100mg/20ml Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
