Gefitinib Tablets 250mg Technical Specification:
| Product Name: | Gefitinib Tablets 250mg |
| Brand Name: | Gefitinib |
| Strength: | 100mg, 250mg |
| Dosage Form: | Film-coated Tablet |
| Packing: | 10s, 30s |
| 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: | Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes. |
| 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). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Gefitinib Tablets 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Gefitinib Tablets 250mg
Each film-coated tablet contains:
Gefitinib…………………………250 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron.
THERAPEUTIC INDICATIONS:
Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospital, 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).
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Gefitinib Tablets 100mg
Gefitinib Tablets 250mg
Gefitinib Tablets 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Gefitinib Tablets 100mg
Each film-coated tablet contains:
Gefitinib…………………………100 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron. Gefitinib Tablets 250mg
Each film-coated tablet contains:
Gefitinib…………………………250 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron.
Each film-coated tablet contains:
Gefitinib…………………………100 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron. Gefitinib Tablets 250mg
Each film-coated tablet contains:
Gefitinib…………………………250 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron.
THERAPEUTIC INDICATIONS:
Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospital, 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: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospital, 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).
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.
