PERSANTINE SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DIPYRIDAMOLE

Dostopno od:

GLENWOOD GMBH PHARMAZEUTISCHE ERZEUGNISSE

Koda artikla:

B01AC07

INN (mednarodno ime):

DIPYRIDAMOLE

Odmerek:

5MG

Farmacevtska oblika:

SOLUTION

Sestava:

DIPYRIDAMOLE 5MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS VASODILATATING AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0106621005; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-11-30

Lastnosti izdelka

_ _
_PERSANTINE Dipyridamole_
_ _
_Product Monograph_
_ _
_Page 1 of 27 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PERSANTINE
®
Dipyridamole for Injection
Solution, 5 mg/mL, intravenous
Coronary Vasodilator
Inhibitor of Platelet Adhesion and Aggregation
Manufactured by:
Glenwood GmbH Pharmazeutische Erzeugnisse
Arabellastr. 17
81925 Munich
Germany
Date of Initial Authorization:
Aug 30, 1960
Date of Revision:
October 31, 2023
Imported by:
McKesson Specialized Distribution Inc.
8449 Lawson Rd, Unit 102
Milton, Ontario L9T 9L1
Submission Control Number: 276658
_ _
_PERSANTINE Dipyridamole Product Monograph _
_Page 2 of 27 _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1 PEDIATRICS
....................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1 DOSING CONSIDERATIONS
................................................................................................
4
4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
........................................................... 4
4.3 RECONSTITUTION
.........................