资料单张
Abbott - Established Products Division
Document ID: BOP.DP17.14.04.F02
Effective By Date: 15-Aug-2012
Document Type: Form
Approved Date: 01-Aug-2012
Title: Mascherina TPM
PLANT:
PRODUCT NAME:
Abbott Chatillon
Faverin 50mg film-coated tablets; Faverin 100mg film-coated tablets
PRESENTATION:
REGULATING COUNTRY:
SALES
X
United Kingdom; Ireland
SAMPLES
REQUEST REFERENCE No:
LCR-00073-2013-DEV; LCR-00074-2013-DEV
COMMODITY CODE:
1086931
COMMODITY TYPE:
Leaflet
CORE SPEC. REF :
COLORS:
Flat leaflet 158x600mm
PHARMACODE:
P. Process Black U -
Cutting die
X X I I X I X X I I (1835)
FONT STYLE / MINIMUM FONT SIZE FOR TEXT:
Helvetica Neue / 8.5 pt
NOTES:
Replaces 1081232 - SOLID 117244
X
06/03/2013
X
08/03/2013
Operator/Dev.
D. Ratkovic
Operator/Dev.
D. Ratkovic
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
Operator/Dev.
LOCAL MARKET REGULATORY SIGN OFF (as appllicable for paper signature)
Confirmation that this artwork has been approved. Text content and colors are correct.
This component conforms with Local Market Regulatory requirements
DATE:
Version 2.0, Effective
Control Site: EPD - Basel CH (Div QA)
Page 1 of 1
This information is confidential to Abbott. The user is responsible for using the appropriate version of this document.
P. Process Black U -
Cutting Die
FRONT
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50 MG AND 100 MG FILM-COATED TABLETS
fluvoxamine maleate
• FAVERIN TREATS DEPRESSION AND OBSESSIVE
COMPULSIVE DI
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产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Faverin 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg fluvoxamine maleate.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, scored, white to off-white film coated tablets imprinted '291' on both
sides of the score.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Major depressive episode
-
Obsessive Compulsive Disorder (OCD)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Depression _
_Adults_
The recommended dose is 100 mg daily. Patients should start on 50 or 100 mg, given
as a single dose in the evening. Dosage should be reviewed and adjusted if necessary
within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically
appropriate. Although there may be an increased potential for undesirable effects at
higher doses, if after some weeks on the recommended dose insufficient response is
seen some patients may benefit from having their dose increased gradually up to a
maximum of 300 mg a day (see section 5.1). Doses up to 150 mg can be given as a
single dose, preferably in the evening. It is advisable that a total daily dose of more
than 150 mg is given in 2 or 3 divided doses. Dosage adjustments should be made
carefully on an individual patient basis, to maintain the patients at the lowest effective
dose.
Patients with depression should be treated for a sufficient period of at least 6 months
to ensure that they are free from symptoms.
_Children/adolescents_
Faverin should not be used in children and adolescents under the
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