AGRYLIN

Страна: Индонезия

Език: индонезийски

Източник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активна съставка:

ANAGRELIDE HYDROCHLORIDE

Предлага се от:

PRATAPA NIRMALA - Indonesia

INN (Международно Name):

ANAGRELIDE HYDROCHLORIDE

дозиране:

0,5 MG

Лекарствена форма:

KAPSUL

Броя в опаковка:

DUS, 1 BOTOL PLASTIK @ 100 KAPSUL

Произведено от:

PATHEON MANUFACTURING SERVICE LLC

Дата Оторизация:

2018-04-23

Данни за продукта

1
AGRYLIN
®
CAPSULES
(anagrelide hydrochloride)
RX ONLY
1.
DESCRIPTION
NAME: AGRYLIN
®
(anagrelide hydrochloride)
DOSAGE FORM: 0.5 mg capsules for oral administration
ACTIVE INGREDIENT: AGRYLIN
®
Capsules contain 0.5 mg of anagrelide base (as anagrelide
hydrochloride).
INACTIVE INGREDIENTS: Anhydrous Lactose NF, Crospovidone NF, Lactose
Monohydrate NF,
Magnesium Stearate NF, Microcrystalline Cellulose NF, Povidone USP.
PHARMACOLOGICAL CLASSIFICATION: Platelet-reducing agent.
CHEMICAL NAME:
6,7-dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one
monohydrochloride monohydrate.
MOLECULAR FORMULA: C
10
H
7
Cl
2
N
3
O•HCl•H
2
O
MOLECULAR WEIGHT: 310.55
STRUCTURAL FORMULA:
APPEARANCE: Off-white powder.
SOLUBILITY:
Water .................................... Very slightly soluble
DimethylSulfoxide ................. Sparingly soluble
Dimethylformamide ............... Sparingly soluble
2.
INDICATIONS AND USAGE
AGRYLIN
®
Capsules are indicated for the treatment of patients with
thrombocythemia,
secondary to myeloproliferative disorders, to reduce the elevated
platelet count and the risk
of thrombosis and to ameliorate associated symptoms including
thrombohemorrhagic events
_[see CLINICAL STUDIES (11) and DOSAGE AND ADMINISTRATION (3)]_.
3.
DOSAGE AND ADMINISTRATION
3.1
DOSAGE
Treatment with AGRYLIN
®
Capsules should be initiated under close medical supervision.
DISETUJUI OLEH BPOM: 31/08/2021
ID: EREG10019112100197
2
Adult and Elderly
The recommended starting dosage of AGRYLIN
®
is 0.5 mg four times daily or 1 mg twice
daily (2 capsules of 0.5 mg twice a day).
Pediatrics
There are limited data on the appropriate starting dose for pediatric
patients. Starting doses
in pediatric patients have ranged from 0.5 mg per day to 0.5 mg four
times daily, so an initial
dose of 0.5 mg per day is recommended.
Hepatic Impairment
It is recommended that patients with moderate hepatic impairment start
anagrelide therapy
at a dose of 0.5 mg/day and be maintained for a minimum of one week
with careful
monitoring of cardiovascular