SEROQUEL

国家: 印度尼西亚

语言: 印度尼西亚文

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

产品特点 产品特点 (SPC)
31-12-2021

有效成分:

QUETIAPINE FUMARATE

可用日期:

ASTRAZENECA INDONESIA - Indonesia

INN(国际名称):

QUETIAPINE FUMARATE

剂量:

230.26 Mg

药物剂型:

TABLET SALUT SELAPUT

每包单位数:

DUS, 6 BLISTER @ 10 TABLET SALUT SELAPUT

厂商:

ASTRAZENECA PHARMACEUTICAL COMPANY LTD. - China

授权日期:

2019-09-28

产品特点

                                1
SEROQUEL

_quetiapine fumarate_
FILM-COATED TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEROQUEL 25
mg contains 25
mg quetiapine (as quetiapine fumarate).
SEROQUEL 100
mg contains 100
mg quetiapine (as quetiapine fumarate).
SEROQUEL 200
mg contains 200
mg quetiapine (as quetiapine fumarate).
SEROQUEL 300
mg contains 300
mg quetiapine (as quetiapine fumarate).
For excipients, see _List of expicients_.
PHARMACEUTICAL FORM
Film-coated tablet.
SEROQUEL 25
mg tablets are peach coloured, round biconvex and engraved with
SEROQUEL 25 on one side.
SEROQUEL 100
mg tablets are yellow, round biconvex and engraved with SEROQUEL 100
on one side.
SEROQUEL 200
mg tablets are white, round biconvex and engraved with SEROQUEL 200
on one side.
SEROQUEL 300
mg tablets are white, capsule-shaped and engraved with SEROQUEL on
one side and 300 on the other side.
THERAPEUTIC INDICATIONS_ _
Treatment of schizophrenia
Treatment of manic episodes associated with bipolar disorder
Treatment of depressive episodes associated with bipolar disorder
POSOLOGY AND METHOD OF ADMINISTRATION
Different dosing schedules exist for each indication. It must
therefore be ensured that
patients receive clear information on the appropriate dosage for their
condition. SEROQUEL
can be administered with or without food.
ADULTS
_FOR THE TREATMENT OF SCHIZOPHRENIA_
SEROQUEL should be administered twice daily. The total daily dose for
the first 4 days of
therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg
(Day 4).
From Day 4 onwards, the dose should be titrated to the usual effective
dose range of 300 to
450
mg/day. Depending on the clinical response and tolerability of the
individual patient, the
dose may be adjusted within the range 150 to 750
mg/day._ _
_ _
_FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER
_
SEROQUEL should be administered twice daily. As monotherapy or as
adjunct therapy to
mood stabilizers, the total daily dose for the first four days of
therapy is 100 mg (Day 1), 200
DISETUJUI OLEH BPOM : 3/12/2021

                                
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