Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ANAGRELIDE HYDROCHLORIDE MONOHYDRATE
Takeda Malaysia Sdn Bhd
ANAGRELIDE HYDROCHLORIDE MONOHYDRATE
100capsule Capsules
Patheon Manufacturing Services LLC
1 Agrylin® capsules 0.5 mg Anagrelide (as hydrochloride) 1. NAME OF THE MEDICINAL PRODUCT Agrylin capsules 0.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 0.5 mg anagrelide (as 0.61 mg anagrelide hydrochloride). Excipient(s) with known effect Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg). For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. An opaque white hard capsule imprinted with S 063. 4. CLINICAL PARTICULARS 4.1 THERAPEUTICAL INDICATIONS Agrylin capsules are indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. _An at-risk patient: _ An at-risk essential thrombocythaemia patient is defined by one or more of the following features: • >60 years of age or • A platelet count >1000 x 109/L or • A history of thrombo-haemorrhagic events. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Agrylin capsules should be initiated by a clinician with experience in the management of essential thrombocythaemia. _Posology _ The recommended starting dosage of anagrelide is 1 mg/day, which should be administered orally in two divided doses (0.5 mg/dose). The starting dose should be maintained for at least one week. After one week the dose may be titrated, on an individual basis, to achieve the lowest effective dose required to reduce and/or maintain a platelet count below 600 x 109/L and ideally at levels between 150 x 109/L and TAKEDA Package insert 2 400 x 109/L. The dose increment must not exceed more than 0.5 mg/day in any one week and the recommended maximum single dose should not exceed 2.5 mg (see section 4.9). During clinical development doses of 10 mg/day have been used. The effects of treatment with anagrelide must be monitored on a regular basis (see section 4.4). If the starting dose is >1 mg/day platelet Baca dokumen lengkapnya