ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ZOLMITRIPTAN

제공처:

SANIS HEALTH INC

ATC 코드:

N02CC03

INN (International Name):

ZOLMITRIPTAN

복용량:

2.5MG

약제 형태:

TABLET (ORALLY DISINTEGRATING)

구성:

ZOLMITRIPTAN 2.5MG

관리 경로:

ORAL

패키지 단위:

6

처방전 유형:

Prescription

치료 영역:

SELECTIVE SEROTONIN AGONISTS

제품 요약:

Active ingredient group (AIG) number: 0134381001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2015-07-31

제품 특성 요약

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_ZOLMITRIPTAN and ZOLMITRIPTAN ODT _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR
ZOLMITRIPTAN
Zolmitriptan
2.5 mg Tablet
PR
ZOLMITRIPTAN ODT
Zolmitriptan
2.5 mg Orally Disintegrating Tablet
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Date of Revision:
August 21, 2020
Submission Control No.:
242166
L6Y 5S5
Brampton, Ontario
1 President’s Choice Circle
Sanis Health
Inc.
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_ZOLMITRIPTAN and ZOLMITRIPTAN ODT _
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
..................................................................