AGRYLIN CAPSULE 0.5 mg

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

ANAGRELIDE (as HCl)

Disponible depuis:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Code ATC:

L01XX35

Dosage:

0.61mg

forme pharmaceutique:

CAPSULE

Composition:

ANAGRELIDE (as HCl) 0.61mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

Patheon Manufacturing Services LLC

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2004-03-19

Notice patient

Technical Info
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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

Résumé des caractéristiques du produit

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
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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