PMS-DICLOFENAC-MISOPROSTOL TABLET (DELAYED-RELEASE)
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
01-06-2022
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:
DICLOFENAC SODIUM; MISOPROSTOL
Fáanlegur frá:
PHARMASCIENCE INC
ATC númer:
M01AB55
INN (Alþjóðlegt nafn):
DICLOFENAC, COMBINATIONS
Skammtar:
75MG; 200MCG
Lyfjaform:
TABLET (DELAYED-RELEASE)
Samsetning:
DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0222885004; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2013-10-01
Vara einkenni
PRODUCT MONOGRAPH
PR
PMS-DICLOFENAC-MISOPROSTOL
Diclofenac Sodium and Misoprostol
Enteric-Coated Tablets, USP
50 mg diclofenac/200 mcg misoprostol
75 mg diclofenac/200 mcg misoprostol
NSAID WITH A MUCOSAL PROTECTIVE AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
June 1, 2022
Submission
Control No: 263143
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_pms-DICLOFENAC-MISOPROSTOL Product Monograph Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL
USE.........................................................................
3
CONTRAINDICATIONS
.............................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE REACTIONS
...........................................................................................
17
DRUG
INTERACTIONS............................................................................................
22
DOSAGE AND
ADMINISTRATION.........................................................................
26
OVERDOSAGE
.........................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 28
STORAGE AND
STABILITY....................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 31
PART II: SCIENTIFIC
INFORMATION...........................................................................
32
PHARMACEUTICAL
INFORMATION.....................................................................
32
CLINICAL TRIALS
...................................................................................................
34
DE
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