Deferasirox Dispersible Tablets 500mg Technical Specification:
| Product Name: | Deferasirox Dispersible Tablets 500mg |
| Brand Name: | Generic |
| Strength: | 100mg, 125mg, 250mg, 400mg, 500mg |
| Dosage Form: | Tablets (Dispersible uncoated tablet) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Iron Chelator, Paediatrics, Metabolism |
| Indication: | This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions |
| Storage: | Store Deferasirox tablets at 25°C (77°F), excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Deferasirox Dispersible Tablets 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Deferasirox Dispersible Tablets 500mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….500mg
Exipients……………………………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:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
DO NOT CHEW OR SWALLOW WHOLE.
Take this medicine on an empty stomach.
Dispense tablet in water before consuming.
Take Defrataj once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Completely disperse tablet by stirring in water until a fine suspension obtained.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store Deferasirox tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Dosage: As directed by the Physician.
| Attach dispensing label as per end country. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Deferasirox Dispersible Tablets 100mg
b) Deferasirox Dispersible Tablets 125mg
c) Deferasirox Dispersible Tablets 250mg
d) Deferasirox Dispersible Tablets 400mg
e) Deferasirox Dispersible Tablets 500mg
b) Deferasirox Dispersible Tablets 125mg
c) Deferasirox Dispersible Tablets 250mg
d) Deferasirox Dispersible Tablets 400mg
e) Deferasirox Dispersible Tablets 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Deferasirox Dispersible Tablets 100mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….100mg
Exipients……………………………q.s.
b) Deferasirox Dispersible Tablets 125mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….125mg
Exipients……………………………q.s.
c) Deferasirox Dispersible Tablets 250mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….250mg
Exipients……………………………q.s.
d) Deferasirox Dispersible Tablets 400mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….400mg
Exipients……………………………q.s.
e) Deferasirox Dispersible Tablets 500mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….500mg
Exipients……………………………q.s.
Each uncoated dispersible tablet contains:
Deferasirox……………………….100mg
Exipients……………………………q.s.
b) Deferasirox Dispersible Tablets 125mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….125mg
Exipients……………………………q.s.
c) Deferasirox Dispersible Tablets 250mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….250mg
Exipients……………………………q.s.
d) Deferasirox Dispersible Tablets 400mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….400mg
Exipients……………………………q.s.
e) Deferasirox Dispersible Tablets 500mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….500mg
Exipients……………………………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:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
DO NOT CHEW OR SWALLOW WHOLE.
Take this medicine on an empty stomach.
Dispense tablet in water before consuming.
Take Defrataj once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Completely disperse tablet by stirring in water until a fine suspension obtained.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
DO NOT CHEW OR SWALLOW WHOLE.
Take this medicine on an empty stomach.
Dispense tablet in water before consuming.
Take Defrataj once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Completely disperse tablet by stirring in water until a fine suspension obtained.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store Deferasirox tablets at 25°C (77°F); excursions are permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
