PMS-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ZOLMITRIPTAN

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

N02CC03

INN (mednarodno ime):

ZOLMITRIPTAN

Odmerek:

2.5MG

Farmacevtska oblika:

TABLET (ORALLY DISINTEGRATING)

Sestava:

ZOLMITRIPTAN 2.5MG

Pot uporabe:

ORAL

Enote v paketu:

6/30

Tip zastaranja:

Prescription

Terapevtsko območje:

SELECTIVE SEROTONIN AGONISTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-06-07

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
PMS-ZOLMITRIPTAN
Zolmitriptan Film-Coated Tablets, House Standard
2.5 mg
PR
PMS-ZOLMITRIPTAN ODT
Zolmitriptan Orally Dispersible Tablets, House Standard
2.5 mg
5-HT1 RECEPTOR AGONIST
MIGRAINE THERAPY
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
April 15, 2020
Submission Control No.: 237071
_ _
_pms-ZOLMITRIPTAN and pms-ZOLMITRIPTAN ODT Product Monograph _
_Page 2 of 41 _
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
....................