APO-DIPYRIDAMOLE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
10-08-2021
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Aktívna zložka:
DIPYRIDAMOLE
Dostupné z:
APOTEX INC
ATC kód:
B01AC07
INN (Medzinárodný Name):
DIPYRIDAMOLE
Dávkovanie:
25MG
Forma lieku:
TABLET
Zloženie:
DIPYRIDAMOLE 25MG
Spôsob podávania:
ORAL
Počet v balení:
250ML
Typ predpisu:
Prescription
Terapeutické oblasti:
MISCELLANEOUS VASODILATATING AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0106621001; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2021-08-12
Súhrn charakteristických
Page 1 of 18
PRODUCT MONOGRAPH
PR
APO-DIPYRIDAMOLE
DIPYRIDAMOLE TABLETS USP
25, 50, 75 AND 100 MG
PR
APO-DIPYRIDAMOLE-SC
DIPYRIDAMOLE SUGAR-COATED TABLETS USP
25, 50 AND 75 MG
CORONARY VASODILATOR
INHIBITOR OF PLATELET ADHESION AND AGGREGATION
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
AUGUST 10, 2021
CONTROL NUMBER: 246833
Page 2 of 18
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT
INFORMATION......................................................................................
3
INDICATIONS AND CLINICAL USES
.........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................................
3
ADVERSE
REACTIONS.............................................................................................................
4
DRUG INTERACTIONS
.............................................................................................................
5
DOSAGE AND ADMINISTRATION
.............................................................................................
6
OVERDOSAGE..........................................................................................................................
6
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................
6
STORAGE AND STABILITY
.......................................................................................................
7
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................................. 7
PART II: SCIENTIFIC INFORMATION
...........................................................................................
9
PHARMACEUTICAL INFORMATION
.............................................
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