Deferasirox Oral Granules Technical Specification:
| Product Name: | Deferasirox Oral Granules |
| Brand Name: | Generic |
| Strength: | 90mg, 180mg, 360mg |
| Dosage Form: | Oral Granules |
| 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 90mg Oral Granules
Deferasirox 180mg oral granules
Deferasirox 360mg oral granules
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each sachets contains 120mg granules
Eq. to Deferasirox….…….90mg
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.
PATIENT INSTRUCTIONS:
Hold sachet with line on top.
Shake sachet gently to settle contents.
Tear sachet open along cut line, or use scissors to cut across line.
Carefully pour entire contents of sachet on soft food such as yogurt or apple sauce.
Make sure that no oral granules remain in the sachet.
The dose should be immediately and completely consume, and not stored for future use.
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.