GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Deferasirox Dispersible Tablets USP 100mg (DEFRATAJ)
B) Deferasirox Dispersible Tablets USP 125mg (DEFRATAJ)
C) Deferasirox Dispersible Tablets USP 250mg (DEFRATAJ)
D) Deferasirox Dispersible Tablets USP 400mg (DEFRATAJ)
E) Deferasirox Dispersible Tablets USP 500mg (DEFRATAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Deferasirox Dispersible Tablets USP 100mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….100mg
Exipients……………………………q.s.

B) Deferasirox Dispersible Tablets USP 125mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….125mg
Exipients……………………………q.s.

C) Deferasirox Dispersible Tablets USP 250mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….250mg
Exipients……………………………q.s.

D) Deferasirox Dispersible Tablets USP 400mg
Each uncoated dispersible tablet contains:
Deferasirox……………………….400mg
Exipients……………………………q.s.

E) Deferasirox Dispersible Tablets USP 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: 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.
Do not chew or swallow whole.
Read enclosed leaflet before use.
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) Protect from moisture.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.

Deferasirox Dispersible Tablets USP 500mg Technical Specification

Product Name:                                        Deferasirox Dispersible Tablets USP 500mg
Brand Name:DEFRATAJ
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:

  1. Deferasirox Dispersible Tablets USP 100mg (DEFRATAJ)
  2. Deferasirox Dispersible Tablets USP 125mg (DEFRATAJ)
  3. Deferasirox Dispersible Tablets USP 250mg (DEFRATAJ)
  4. Deferasirox Dispersible Tablets USP 400mg (DEFRATAJ)
  5. Deferasirox Dispersible Tablets USP 500mg (DEFRATAJ)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Deferasirox Dispersible Tablets USP 100mg
    Each uncoated dispersible tablet contains:
    Deferasirox……………………….100mg
    Exipients……………………………q.s.
  • Deferasirox Dispersible Tablets USP 125mg
    Each uncoated dispersible tablet contains:
    Deferasirox……………………….125mg
    Exipients……………………………q.s.
  • Deferasirox Dispersible Tablets USP 250mg
    Each uncoated dispersible tablet contains:
    Deferasirox……………………….250mg
    Exipients……………………………q.s.
  • Deferasirox Dispersible Tablets USP 400mg
    Each uncoated dispersible tablet contains:
    Deferasirox……………………….400mg
    Exipients……………………………q.s.
  • Deferasirox Dispersible Tablets USP 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: 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.
Do not chew or swallow whole.
Read enclosed leaflet before use.

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) Protect from moisture.
Keep medicine out of reach of children.
Dosage:  As directed by the Physician.