TARO-ACITRETIN CAPSULE
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
14-07-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ACITRETIN
Fáanlegur frá:
TARO PHARMACEUTICALS INC
ATC númer:
D05BB02
INN (Alþjóðlegt nafn):
ACITRETIN
Skammtar:
25MG
Lyfjaform:
CAPSULE
Samsetning:
ACITRETIN 25MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0122473001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2017-07-10
Vara einkenni
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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