TARO-ACITRETIN CAPSULE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
14-07-2017

Viambatanisho vya kazi:

ACITRETIN

Inapatikana kutoka:

TARO PHARMACEUTICALS INC

ATC kanuni:

D05BB02

INN (Jina la Kimataifa):

ACITRETIN

Kipimo:

25MG

Dawa fomu:

CAPSULE

Tungo:

ACITRETIN 25MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30

Dawa ya aina:

Prescription

Eneo la matibabu:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0122473001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2017-07-10

Tabia za bidhaa

                                Page 1 of 52
PRODUCT MONOGRAPH
PR
TARO-ACITRETIN
(Acitretin Capsules)
10 mg and 25 mg
Taro Standard
Keratinization Disorder Treatment
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario
Canada L6T 1C1
CONTROL NUMBER: 200188
DATE OF PREPARATION:
July 07, 2017
Page 2 of 52
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.......................................................................3
INDICATIONS AND CLINICAL USE
.............................................................................3
CONTRAINDICATIONS
..................................................................................................4
WARNINGS AND PRECAUTIONS
.................................................................................6
ADVERSE REACTIONS
.................................................................................................16
DRUG INTERACTIONS
.................................................................................................24
DOSAGE AND ADMINISTRATION
.............................................................................26
OVERDOSAGE
...............................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
...........................................................28
STORAGE AND STABILITY
.........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL INFORMATION
.........................................................................31
CLINICAL TRIALS
.........................................................................................................31
DETAILED 
                                
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