RAMIPRIL-2.5 CAPSULE
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
27-01-2016
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Aktiv ingrediens:
RAMIPRIL
Tilgjengelig fra:
SIVEM PHARMACEUTICALS ULC
ATC-kode:
C09AA05
INN (International Name):
RAMIPRIL
Dosering :
2.5MG
Legemiddelform:
CAPSULE
Sammensetning:
RAMIPRIL 2.5MG
Administreringsrute:
ORAL
Enheter i pakken:
100/500
Resept typen:
Prescription
Terapeutisk område:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0122858004; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2016-06-29
Preparatomtale
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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