DOM-CIPROFLOXACIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-09-2019
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Active ingredient:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
Available from:
DOMINION PHARMACAL
ATC code:
J01MA02
INN (International Name):
CIPROFLOXACIN
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 100MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
QUINOLONES
Product summary:
Active ingredient group (AIG) number: 0123207005; AHFS:
Authorization status:
APPROVED
Authorization date:
2004-03-24
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DOM-CIPROFLOXACIN
(Ciprofloxacin Hydrochloride Tablets, USP)
100 mg, 250 mg, 500 mg and 750 mg
ANTIBACTERIAL AGENT
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100,
Montréal, Quebec
H4P 2T4 DATE OF REVISION: SEPTEMBER 10, 2019
SUBMISSION CONTROL NO.: 229111
_Dom-CIPROFLOXACIN Product Monograph _
_Page 2 of 49_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
6
WARNINGS AND PRECAUTIONS
............................................................................................
6
ADVERSE REACTIONS
............................................................................................................
11
DRUG INTERACTIONS
............................................................................................................
14
DOSAGE AND ADMINISTRATION
........................................................................................
19
OVERDOSAGE
...........................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
21
STORAGE AND STABILITY
....................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 23
PART II: SCIENTIFIC INFORMATION
..................................................................................
25
PHARMACEUTICAL INFORMATION
..........................................................................
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