地拉罗司说明书

Indian Cipla Instructions

Generic name: Deferasirox

Product name: Enrig

All names: Deferasirox, Enrig, Deferasirox, Desirox

Indications: For the treatment of chronic iron overload in patients with β-thalassemia who are older than 6 years old due to frequent blood transfusions (monthly administration of concentrated red blood cells ≥7mL/kg); for children under 6 years old and iron overload caused by other transfusion-dependent diseases, the safety and effectiveness data of Enrig in Chinese patients are limited, and it is recommended to use it with caution based on the specific situation of the patient.

Usage and Dosage: Starting dose: The recommended starting daily dose of deferasirox is 20 mg/kg. For patients who receive monthly transfusions of more than 14 mL/kg of packed red blood cells (i.e., more than 4 units/month in adults) and need to reduce excessive iron exposure, a starting dose of 30 mg/kg/day may be considered. For monthly Patients who receive less than 7 mL/kg packed red blood cell transfusions (i.e., less than 2 units/month in adults) and need to maintain body iron balance may consider an initial dose of 10 mg/kg/day. Patients who have already responded well to deferoxamine treatment may consider an initial Enrig dose equivalent to half the deferoxamine dose. (For example, a patient receiving deferoxamine 40 mg/kg/day, 5 days a week or equivalent, can start with 20 mg/kg if switched to Enriga.) Dosage: Deferasirox should be taken on an empty stomach at least 30 minutes before meals, once a day, preferably at the same time every day. The tablets should not be chewed or swallowed whole. Deferasirox should not be taken with aluminum-containing antacids. The dosage (mg/kg) needs to be calculated and rounded to the nearest whole tablet. Dissolve the tablets completely in water, apple juice or orange juice (100-200mL) by stirring until a clear suspension is obtained and then drink it. The remaining drug must be mixed with a small amount of water, apple juice or orange juice before taking it. Not recommended for dissolution in carbonated drinks or milk as it can cause foaming and slow dispersion.

Storage: Store at room temperature 25°C (77°F); excursions allowed 15-30°C (59-86°F); protect against moisture.

The above is the instructions for Cipla in India. Please read it carefully and use it under the guidance of a licensed physician.

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