JAMP-MOXIFLOXACIN SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Dostupné s:

JAMP PHARMA CORPORATION

ATC kód:

S01AE07

INN (Mezinárodní Name):

MOXIFLOXACIN

Dávkování:

0.5%

Léková forma:

SOLUTION

Složení:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 0.5%

Podání:

OPHTHALMIC

Jednotky v balení:

3ML

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTIBACTERIALS

Přehled produktů:

Active ingredient group (AIG) number: 0142242003; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2018-04-24

Charakteristika produktu

_Jamp-Moxifloxacin Product Monograph_
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
JAMP-MOXIFLOXACIN
Moxifloxacin Ophthalmic Solution USP
0.5% w/v moxifloxacin (as hydrochloride)
sterile
Antibacterial (ophthalmic)
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Preparation:
January 18, 2018
Submission Control No.: 203089
_Jamp-Moxifloxacin Product Monograph_
_Page 2 of 27_
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
....................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
7
DOSAGE AND ADMINISTRATION
................................................................................
8
OVERDOSAGE
...................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 8
STORAGE AND STABILITY
............................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 10
PART II: SCIENTIFIC INFORMATION
.................................................................................
11
PHARMACEUTICAL INFORMATION
..........................................................................
11
CLINICAL TRIALS
......................