Sorafenib Tablets 200mg (Sorataj) Technical Specification:
| Product Name: | Sorafenib Tablets 200mg |
| Brand Name: | Sorataj |
| Strength: | 200mg |
| Dosage Form: | Film-coated Tablet |
| Packing: | 30s, 60s, 120s |
| Route of Administration: | For Oral 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: | Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body. |
| Storage: | Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sorafenib Tablets 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sorafenib Tablets 200mg
Each film-coated tablet contains:
Sorafenib Tosylate Equivalent to
Sorafenib………………………200 mg
Excipients……………………..q.s.
Colours: Titanium Dioxide USP, Ferric Oxide Red.
THERAPEUTIC INDICATIONS:
Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from light.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Sorafenib Tablets 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Sorafenib Tablets 200mg
Each film-coated tablet contains:
Sorafenib Tosylate Equivalent to
Sorafenib………………………200 mg
Excipients……………………..q.s.
Colours: Titanium Dioxide USP, Ferric Oxide Red.
Each film-coated tablet contains:
Sorafenib Tosylate Equivalent to
Sorafenib………………………200 mg
Excipients……………………..q.s.
Colours: Titanium Dioxide USP, Ferric Oxide Red.
THERAPEUTIC INDICATIONS:
Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from light.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
