PMS-DICLOFENAC-MISOPROSTOL TABLET (DELAYED-RELEASE)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
01-06-2022
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
DICLOFENAC SODIUM; MISOPROSTOL
Inapatikana kutoka:
PHARMASCIENCE INC
ATC kanuni:
M01AB55
INN (Jina la Kimataifa):
DICLOFENAC, COMBINATIONS
Kipimo:
75MG; 200MCG
Dawa fomu:
TABLET (DELAYED-RELEASE)
Tungo:
DICLOFENAC SODIUM 75MG; MISOPROSTOL 200MCG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Prescription
Eneo la matibabu:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0222885004; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2013-10-01
Tabia za bidhaa
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
_ _
_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
Soma hati kamili
