Deferasirox Tablets Technical Specification:
| Product Name: | Deferasirox USP 180mg Tablets |
| Brand Name: | Generic |
| Strength: | 90mg, 180mg, 360mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 30s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, FSC, COPP and CTD Dossier |
| Therapeutic use: | Iron chelator /Thalassemia syndrome |
| Indication: | Deferasirox is used to remove excess iron from the body in patients who have had too many blood transfusions and in patients with non-transfusion dependent thalassemia syndromes. Deferasirox is an iron chelator (binder). It combines with iron in the blood. |
| Storage: | Store at 20℃ to 25℃ (68°F TO 77°F);excursions permitted to 15℃ to 30℃ (59°F to 86°F)(See USP Controlled Room Temperature).Protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Deferasirox USP 90mg Tablet
Deferasirox USP 180mg tablet
Deferasirox USP 360mg tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablets contains
Deferasirox….…….180mg
THERAPEUTIC INDICATIONS:
Deferasirox is used to remove excess iron from the body in patients who have had too many blood transfusions and in patients with non-transfusion dependent thalassemia syndromes. Deferasirox is an iron chelator (binder). It combines with iron in the blood.
CAUTION &WARNING:
Keep out of reach of children.
PHARMACIST: Dispense with accompanying medication guidance to each patient
STORAGE & DOSAGE:
Storage: Store at 20℃ to 25℃ (68°F TO 77°F); excursions permitted to 15℃ to 30℃ (59°F to 86°F) (See USP Controlled Room Temperature). Protect from moisture.
Dosage: See prescribing information for dosage and administration.