NTP-ATENOLOL/CHLORTHALIDONE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
19-07-2013
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Aktiv ingrediens:
ATENOLOL; CHLORTHALIDONE
Tilgjengelig fra:
TEVA CANADA LIMITED
ATC-kode:
C07CB03
INN (International Name):
ATENOLOL AND OTHER DIURETICS
Dosering :
50MG; 25MG
Legemiddelform:
TABLET
Sammensetning:
ATENOLOL 50MG; CHLORTHALIDONE 25MG
Administreringsrute:
ORAL
Enheter i pakken:
30/100
Resept typen:
Prescription
Terapeutisk område:
BETA-ADRENERGIC BLOCKING AGENTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0216877002; AHFS:
Autorisasjon status:
CANCELLED PRE MARKET
Autorisasjon dato:
2015-08-06
Preparatomtale
PRODUCT MONOGRAPH
Pr
NTP-ATENOLOL/CHLORTHALIDONE
(atenolol/chlorthalidone tablets, USP)
50/25 mg and 100/25 mg
Antihypertensive Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
July 12, 2013
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165857
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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
....................................................................................................
9
DRUG INTERACTIONS
..................................................................................................
13
DOSAGE AND ADMINISTRATION
..............................................................................
15
OVERDOSAGE
.................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 17
STORAGE AND STABILITY
..........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL INFORMATION
..........................................................................
20
PHARMACEUTICAL INFORMATION
..........................................................................
21
CLINICAL TRIALS
..................................................................................
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