País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
ANAGRELIDE (as HCl)
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
L01XX35
0.61mg
CAPSULE
ANAGRELIDE (as HCl) 0.61mg
ORAL
Prescription Only
Patheon Manufacturing Services LLC
ACTIVE
2004-03-19
Technical Info Profile Submission Mock-up Shire Final Proof Print at Risk Printer’s Proof Submission Mock-up Shire Final Proof Print at Risk Printer’s Proof Signature: Signature: GFW-045 00 1ST AW PERSON APPROVAL: 2ND AW PERSON APPROVAL: REGULATORY RESPONSIBLE PERSON APPROVAL: MARKETING RESPONSIBLE PERSON APPROVAL: xxxxvx Agrylin Singapore PIL 0.5mg 100ct 13080715222351 N/A 388930A04 13-0030 3 420 X 297mm 03-09-13 Black FONTS USED: Britannic EF-Medium NimbusSanLOT-Bold NimbusSanLOT-Italic NimbusSanLOT-Regular NimbusSanLOTBla-Regular Verdana-Regular SMALLEST POINT SIZED USED: 5.0 pt AVERAGE TEXT SIZE (BODY TEXT): 8.0 pt (12) of children (age range 5-17 years) with essential thrombocythaemia were treated with anagrelide. 5.2 PHARMACOKINETIC PROPERTIES Following oral administration of anagrelide in man, at least 70% is absorbed from the gastrointestinal tract. In fasted subjects, peak plasma levels occur about 1 hour after a 0.5mg dose; the plasma half-life is short, approximately 1.3 hours. Dose proportionality has been found in the dose range 0.5mg to 2mg. Anagrelide is primarily metabolised by CYP1A2; less than 1% is recovered in the urine as anagrelide. Two major urinary metabolites, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline and 3-hydroxy anagrelide have been identified. The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose. Pharmacokinetic data from healthy subjects established that food decreases the C max of anagrelide by 14%, but increases the AUC by 20%. Food had a more significant effect on the active metabolite and decreased the C max by 29%, although it had no effect on the AUC. As expected from its half-life, there is no evidence for anagrelide accumulation in the plasma. Additionally, these results show no evidence of auto-induction of anagrelide clearance. SPECIAL POPULATIONS _Paediatric population: _Pharmacokinetic data from fasting children and adolescents (age range 7 Leia o documento completo
FONTS USED: BritannicEF-Medium PraxisCom-Bold PraxisCom-Oblique PraxisCom-Regular PraxisCom-Semibold SMALLEST POINT SIZED USED: 5.0 pt AVERAGE TEXT SIZE (BODY TEXT): 8.0 pt Profile Technical Info GFW-045 00 SHI1918V11 1918V11 Agrylin - PIL Singapore 0.5mg 100 Capsules 220616033600775 1587 402894401 0020 1 420x449mm 22-06-2022 50824.1357 Wasdell Black SGK IS A MATTHEWS INTERNATIONAL CORPORATION COMPONENT CODE: DAL NUMBER / VERSION: DESCRIPTION: PHARMA CODE : SCHAWK JOB NUMBER: PASS NUMBER: DIMENSIONS: ARTWORK DATE: PROFILE ASSET NO.: CMO NAME: PACKAGE INSERT Agrylin ® CAPSULES 0.5 MG Anagrelide (as hydrochloride) 1. NAME OF THE MEDICINAL PRODUCT Agrylin capsules 0.5mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 0.5 mg anagrelide (as 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 THERAPEUTIC INDICATIONS Agrylin is indicated for the reduction of elevated platelet counts in patients with essential thrombocythaemia (ET) who are intolerant to their existing therapy or for whom other therapies are not considered appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Agrylin 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 dosage may be titrated, on an individual basis, to achieve the lowest effective dosage required to reduce and/or maintain a platelet count below 600 x 10 9 /L and ideally at levels between 150 x 10 9 /L and 400 x 10 9 /L. The dosage increment must not exceed 0.5 mg/day in any one week and the recommended maximum single dose should not Leia o documento completo