NOVO-ACEBUTOLOL (TYPE S) TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
06-07-2007
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Aktívna zložka:
ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE)
Dostupné z:
NOVOPHARM LIMITED
ATC kód:
C07AB04
INN (Medzinárodný Name):
ACEBUTOLOL
Dávkovanie:
100MG
Forma lieku:
TABLET
Zloženie:
ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE) 100MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
BETA-ADRENERGIC BLOCKING AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0131282001; AHFS:
Stav Autorizácia:
CANCELLED PRE MARKET
Dátum Autorizácia:
2015-10-16
Súhrn charakteristických
PRODUCT MONOGRAPH
Pr
NOVO-ACEBUTOLOL (TYPE S)
(Acebutolol Hydrochloride)
100, 200 and 400 mg Tablets
Novopharm Standard
ANTIHYPERTENSIVE AND ANTI-ANGINAL AGENT
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 103290, 110614
Date of Preparation:
May 11, 2007
_Page 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....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE.................................................................................................................11
ACTION AND CLINICAL
PHARMACOLOGY.............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL
INFORMATION..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
DETAILED PHARMACOLOGY
.......................................................
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