FLUANXOL DEPOT 10%- LIQ IM 100MG/ML SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
12-12-2017

Viambatanisho vya kazi:

FLUPENTIXOL DECANOATE

Inapatikana kutoka:

LUNDBECK CANADA INC

ATC kanuni:

N05AF01

INN (Jina la Kimataifa):

FLUPENTIXOL

Kipimo:

100MG

Dawa fomu:

SOLUTION

Tungo:

FLUPENTIXOL DECANOATE 100MG

Njia ya uendeshaji:

INTRAMUSCULAR

Vitengo katika mfuko:

10X1ML/2ML

Dawa ya aina:

Prescription

Eneo la matibabu:

THIOXANTHENES

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0114584002; AHFS:

Idhini hali ya:

MARKETED

Idhini ya tarehe:

1995-12-31

Tabia za bidhaa

                                _ _
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_Page 1 of 35 _
November 17, 2017
PRODUCT MONOGRAPH
Pr
FLUANXOL
®
Flupentixol Tablets
(as flupentixol dihydrochloride)
0.5 mg, 3 mg, and 5 mg
Pr
FLUANXOL
®
DEPOT
Flupentixol Decanoate Intramuscular Injection
2% and 10% flupentixol decanoate
ANTIPSYCHOTIC AGENT
Lundbeck Canada Inc.
2600 Alfred-Nobel
Suite 400
St-Laurent, QC
H4S 0A9
Date of Revision:
December 12, 2017
Submission Control No : 209135
_ _
_ _
_Page 2 of 35_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
DETAILED PHARMACOLOGY
.................................................
                                
                                Soma hati kamili
                                
                            

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Tabia za bidhaa Tabia za bidhaa Kifaransa 12-12-2017