TEVA-TRANDOLAPRIL CAPSULE
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
29-10-2020
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Aktivna sestavina:
TRANDOLAPRIL
Dostopno od:
TEVA CANADA LIMITED
Koda artikla:
C09AA10
INN (mednarodno ime):
TRANDOLAPRIL
Odmerek:
1MG
Farmacevtska oblika:
CAPSULE
Sestava:
TRANDOLAPRIL 1MG
Pot uporabe:
ORAL
Enote v paketu:
30/100
Tip zastaranja:
Prescription
Terapevtsko območje:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Povzetek izdelek:
Active ingredient group (AIG) number: 0131524002; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2018-09-26
Lastnosti izdelka
PRODUCT MONOGRAPH
PR
TEVA-TRANDOLAPRIL
Trandolapril Capsules
0.5 mg, 1 mg, 2 mg and 4 mg
Angiotensin-Converting Enzyme Inhibitor
Teva Canada Limited
Date of Revision:
30 Novopharm Court
October 29, 2020
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 244602
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
.............................................................................................
11
DRUG INTERACTIONS
.............................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................
20
OVERDOSAGE
...........................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 22
STORAGE AND STABILITY
.....................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 26
PART II: SCIENTIFIC INFORMATION
................................................................... 28
PHARMACEUTICAL INFORMATION
.....................................................................
28
CLINICAL TRIALS
.....................................................................................................
29
DETAILED PHARMACOLOGY
................................................................................
31
TOXICOLOGY
....................................................................
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