Riik: Kanada
keel: inglise
Allikas: Health Canada
ACITRETIN
TARO PHARMACEUTICALS INC
D05BB02
ACITRETIN
25MG
CAPSULE
ACITRETIN 25MG
ORAL
30
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0122473001; AHFS:
APPROVED
2017-07-10
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 Lugege kogu dokumenti