RAMIPRIL-2.5 CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-01-2016
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Active ingredient:
RAMIPRIL
Available from:
SIVEM PHARMACEUTICALS ULC
ATC code:
C09AA05
INN (International Name):
RAMIPRIL
Dosage:
2.5MG
Pharmaceutical form:
CAPSULE
Composition:
RAMIPRIL 2.5MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0122858004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-06-29
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
RAMIPRIL-2.5
PR
RAMIPRIL-5
PR
RAMIPRIL-10
RAMIPRIL CAPSULES, MANUFACTURER’S STANDARD
2.5 MG, 5.0 MG AND 10.0 MG
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
SIVEM PHARMACEUTICALS ULC
4705 DOBRIN STREET
SAINT-LAURENT, QUEBEC
DATE OF PREPARATION:
H4R 2P7
JANUARY 12, 2016
CONTROL NO.: 190207
2
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
.......................................................................................................
10
DRUG INTERACTIONS
.......................................................................................................
15
DOSAGE AND ADMINISTRATION
...................................................................................
17
OVERDOSAGE
......................................................................................................................
23
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
18
STORAGE AND STABILITY
...............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 26
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
...............................................................................
23
CLINICAL TRIALS
.........................................................................................................
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