APO-ZOLMITRIPTAN RAPID TABLET (ORALLY DISINTEGRATING)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

ZOLMITRIPTAN

可用日期:

APOTEX INC

ATC代码:

N02CC03

INN（国际名称）:

ZOLMITRIPTAN

剂量:

2.5MG

药物剂型:

TABLET (ORALLY DISINTEGRATING)

组成:

ZOLMITRIPTAN 2.5MG

给药途径:

ORAL

每包单位数:

2/6

处方类型:

Prescription

治疗领域:

SELECTIVE SEROTONIN AGONISTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2012-03-09

产品特点

Page 1 of
39
PRODUCT MONOGRAPH
PR
APO-ZOLMITRIPTAN
(ZOLMITRIPTAN) FILM COATED TABLETS
2.5 MG
PR
APO-ZOLMITRIPTAN RAPID
(ZOLMITRIPTAN) ORALLY DISINTEGRATING TABLETS
2.5 MG
PROFESSED STANDARD
5-HT
1 RECEPTOR AGONIST
MIGRAINE THERAPY`
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION: APRIL 2, 2020
CONTROL NUMBER: 237796
Page 2 of
39
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL
USE.................................................................................................
3
CONTRAINDICATIONS
...................................................................................................................
4
WARNINGS AND
PRECAUTIONS...................................................................................................
4
ADVERSE REACTIONS
................................................................................................................
11
DRUG INTERACTIONS
.................................................................................................................
16
DOSAGE AND ADMINISTRATION
................................................................................................
17
OVERDOSAGE
..............................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.................................................................................
19
STORAGE AND STABILITY
..........................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................. 22
PART II: SCIENTIFIC INFORMATION
................................................................................................
23
PHARMACEUTICAL INF