MINT-ACITRETIN CAPSULE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ACITRETIN

থেকে পাওয়া:

MINT PHARMACEUTICALS INC

এটিসি কোড:

D05BB02

INN (আন্তর্জাতিক নাম):

ACITRETIN

ডোজ:

10MG

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

ACITRETIN 10MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

30

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0122473002; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2017-10-18

পণ্য বৈশিষ্ট্য

Page 1 of 51
PRODUCT MONOGRAPH
PR
MINT-ACITRETIN
Acitretin Capsules, BP
10 mg and 25 mg
Keratinization Disorder Treatment
Mint Pharmaceuticals Inc.
Date of Preparation: October 4, 2017
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
L5T 1J6
Submission Control No: 194389
Page 2 of 51
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
....................................................................................................
15
DRUG INTERACTIONS
.....................................................................................................
23
DOSAGE AND ADMINISTRATION
.................................................................................
25
OVERDOSAGE
...................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 27
STORAGE AND STABILITY
............................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 29
PART II: SCIENTIFIC INFORMATION
...................................................................................
30
PHARMACEUTICAL INFORMATION
............................................................................
30
CLINICAL
TRIALS..........................................