MYLAN-VERAPAMIL SR TABLET (EXTENDED-RELEASE)
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
15-01-2020
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Aktivní složka:
VERAPAMIL HYDROCHLORIDE
Dostupné s:
MYLAN PHARMACEUTICALS ULC
ATC kód:
C08DA01
INN (Mezinárodní Name):
VERAPAMIL
Dávkování:
120MG
Léková forma:
TABLET (EXTENDED-RELEASE)
Složení:
VERAPAMIL HYDROCHLORIDE 120MG
Podání:
ORAL
Jednotky v balení:
100
Druh předpisu:
Prescription
Terapeutické oblasti:
MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0113846001; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2016-01-08
Charakteristika produktu
1
PRODUCT MONOGRAPH
PR
MYLAN-VERAPAMIL
SR
verapamil hydrochloride sustained-release tablets, USP
120 mg, 180 mg and 240 mg
Antihypertensive Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke ON
M8Z 2S6
Control No: 235062
Date of Revision: January 15, 2020
2
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
...........................................................................................................................
14
DOSAGE AND ADMINISTRATION
.......................................................................................................
24
OVERDOSAGE
.........................................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................
27
STORAGE AND STABILITY
...................................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
32
PART II: SCIENTIFIC INFORMATION
.....................................................................................................
34
PHARMACEUTICAL INFORMATION
........
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