Deferasirox Dispersible Tablets Technical Specification:
| Product Name: | Deferasirox Tablets for Oral Suspension |
| Brand Name: | Generic |
| Strength: | 125mg, 250mg, 400mg, 500mg |
| Dosage Form: | Tablets (Uncoated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 6s, 10s, 28s, 30s, 100s |
| 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 dispersible USP 125mg Tablet
Deferasirox dispersible USP 250mg Tablet
Deferasirox dispersible USP 400mg Tablet
Deferasirox dispersible USP 500mg Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each dispersible tablet contains:
Deferasirox USP…….400mg
Eq. ……………………. Q.S.
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:
Store in original package.
Keep out of reach of children.
Take this medicine once a daily 30min before food
Read the package leaflet before use.
Dispersed tablet in water, Apple or Orange juice prior to ingestion.
Do not swallow whole or chew.
WARNING: To be sold by retail on the prescription of Specialist only.
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.