Quetiapine Sandoz 25 mg Tablets

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Quetiapine 25 mg (as 28.78 mg quetiapine fumarate)

Հասանելի է:

SANDOZ SINGAPORE PTE. LTD.

ATC կոդը:

N05AH04

Դոզան:

25 mg

Դեղագործական ձեւ:

TABLET, FILM COATED

Կազմը:

Quetiapine 25 mg (as 28.78 mg quetiapine fumarate) 25 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Genveon Ilac Sanayi ve Ticaret A.S.

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2010-07-26

Ապրանքի հատկությունները

QUETIAPINE SANDOZ 25 MG AND 100 MG TABLETS
Page
1
of
16
1.
NAME OF THE MEDICINAL PRODUCT
Quetiapine Sandoz 25 mg Tablets.
Quetiapine Sandoz 100 mg Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quetiapine Sandoz 25 mg Tablets
Each film-coated tablet contains 25 mg quetiapine (as 28.78 mg
quetiapine fumarate).
Quetiapine Sandoz 100 mg Tablets
Each film-coated tablet contains 100 mg quetiapine (as 115.13 mg
quetiapine fumarate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Quetiapine Sandoz 25 mg Tablets
Salmon-pink coloured, round film-coated tablet.
Quetiapine Sandoz 100 mg Tablets
Yellow, round (8.8 mm diameter) film-coated tablet, with a breaking
notch on one side.
The tablet can be divided into equal quarters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of schizophrenia.
•
Treatment of acute manic episodes associated with bipolar I disorder.
•
Treatment of depressive episodes associated with bipolar disorder.
•
Preventing recurrence in maintenance treatment of bipolar I disorder
(manic, mixed or depressive episode) as
monotherapy or in combination with lithium or valproate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Quetiapine should be administered with or without food.
ADULTS
_FOR THE TREATMENT OF SCHIZOPHRENIA: _
Quetiapine should be administered twice daily, with or without food.
The total daily dose for the first 4 days of therapy is 50 mg
Quetiapine (Day 1), 100 mg Quetiapine (Day 2), 200
mg Quetiapine (Day 3) and 300 mg Quetiapine (Day 4).
From Day 4 onwards, the dose should be titrated to the usual effective
dose range of 300 to 450 mg Quetiapine
per day. Depending on the clinical response and tolerability of the
individual patient, the dose may be adjusted
within the range of 150 to 750 mg Quetiapine per day.
_FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER:
_
Quetiapine should be administered twice daily, with or without food.
As monotherapy or as adjunct therapy to mood stabilizers, the total
daily