APO-LABETALOL TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
24-08-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
LABETALOL HYDROCHLORIDE
Fáanlegur frá:
APOTEX INC
ATC númer:
C07AG01
INN (Alþjóðlegt nafn):
LABETALOL
Skammtar:
200MG
Lyfjaform:
TABLET
Samsetning:
LABETALOL HYDROCHLORIDE 200MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
BETA-ADRENERGIC BLOCKING AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0116170003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2001-03-09
Vara einkenni
Page 1 of 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LABETALOL
LABETALOL HYDROCHLORIDE TABLETS USP
100 MG AND 200 MG OF LABETALOL HYDROCHLORIDE
ANTIHYPERTENSIVE AGENT
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE August 24, 2020
WESTON, ONTARIO
M9L 1T9
Control Number: 239427
Page 2 of 22
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
............................................................................................................
7
DRUG INTERACTIONS
.............................................................................................................
9
DOSAGE AND ADMINISTRATION
..........................................................................................
10
OVERDOSAGE
.......................................................................................................................
10
ACT ION AND CLINICAL
PHARMACOLOGY..........................................................................
11
STORAGE AND STABILITY
....................................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 12
PART II: SCIENTIFIC INFORMATION
........................................................................................
14
PHARMACEUTICAL INFORMATION
......................................................................................
14
CLINICAL TRIALS
........
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