MAR-CIPROFLOXACIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Διαθέσιμο από:

MARCAN PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

J01MA02

INN (Διεθνής Όνομα):

CIPROFLOXACIN

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10/50/1000

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

QUINOLONES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0123207001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2012-02-22

Αρχείο Π.Χ.Π.

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MAR-CIPROFLOXACIN
Ciprofloxacin Tablets
Tablets, 250 mg, 500 mg and 750mg ciprofloxacin (as ciprofloxacin
hydrochloride), Oral
British Pharmacopoeia (BP)
Antibacterial Agent
Marcan Pharmaceuticals Inc.,
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Submission Control Number: 265922
Date of Initial Authorization:
FEB 22, 2021
Date of Revision:
JUL 22, 2022
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RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2022
4 DOSAGE AND ADMINISTRATION, 4.5 MISSED DOSE
07/2022
7 WARNINGS AND PRECAUTIONS
10/2020
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL
CHANGES………………………………………………………………………………………………2
TABLE OF
CONTENTS…………………………………………………………………………………………………………………2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1. INDICATIONS
......................................................................................................................
4
1.1 Pediatrics
...............................................................................................................................
7
1.2 Geriatrics
...............................................................................................................................
7
2. CONTRAINDICATIONS
.........................................................................................................
7
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
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8
4. DOSAGE AND ADMINISTRATION
.........................................................................................
8
4.1 Dosing
Considerations.............................................................