ACEBUTOLOL-100 TABLET
Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
Produkta apraksts
(SPC)
11-07-2019
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Aktīvā sastāvdaļa:
ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE)
Pieejams no:
PRO DOC LIMITEE
ATĶ kods:
C07AB04
SNN (starptautisko nepatentēto nosaukumu):
ACEBUTOLOL
Deva:
100MG
Zāļu forma:
TABLET
Kompozīcija:
ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE) 100MG
Ievadīšanas:
ORAL
Vienības iepakojumā:
100/500 COMPRIMES
Receptes veids:
Prescription
Ārstniecības joma:
BETA-ADRENERGIC BLOCKING AGENTS
Produktu pārskats:
Active ingredient group (AIG) number: 0131282001; AHFS:
Autorizācija statuss:
CANCELLED POST MARKET
Autorizācija datums:
2022-07-14
Produkta apraksts
Page 1 of 33
PRODUCT MONOGRAPH
Pr
ACEBUTOLOL – 100
Pr
ACEBUTOLOL – 200
Pr
ACEBUTOLOL – 400
Acebutolol Tablets (as Acebutolol Hydrochloride)
Manufacturer Standard
100 mg, 200 mg and 400 mg Tablets
Antihypertensive and Anti-anginal Agent
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
July 11, 2019
Laval, Quebec
H7L 3W9
Control Number#:228198
Page 2 of 33
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
.............................................................................................................................................
12
DOSAGE AND ADMINISTRATION
.........................................................................................................................
15
OVERDOSAGE
...........................................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................................................
17
STORAGE AND STABILITY
......................................................................................................
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