APO-LATANOPROST-TIMOP SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

LATANOPROST; TIMOLOL (TIMOLOL MALEATE)

זמין מ:

APOTEX INC

קוד ATC:

S01ED51

INN (שם בינלאומי):

TIMOLOL, COMBINATIONS

כמות:

50MCG; 5MG

טופס פרצבטיות:

SOLUTION

הרכב:

LATANOPROST 50MCG; TIMOLOL (TIMOLOL MALEATE) 5MG

מסלול נתינה (של תרופות):

OPHTHALMIC

יחידות באריזה:

2.5ML

סוג מרשם:

Prescription

איזור תרפויטי:

BETA-ADRENERGIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0248501002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2013-10-10

מאפייני מוצר

Page 1 of 30
PRODUCT MONOGRAPH
PR
APO-LATANOPROST-TIMOP
LATANOPROST 50 MCG/ML AND TIMOLOL 5 MG/ML AS TIMOLOL MALEATE
OPHTHALMIC SOLUTION
STERILE
ELEVATED INTRAOCULAR PRESSURE THERAPY
PROSTAGLANDIN F
2Α
ANALOGUE AND BETA-ADRENERGIC RECEPTOR BLOCKER
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE
AUGUST 16, 2018
TORONTO ONTARIO
M9L 1T9
CONTROL NO.: 216591
Page 2 of 30
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
...................................................................................
4
ADVERSE REACTIONS
....................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................
13
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 14
STORAGE AND STABILITY
............................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 15
PART II: SCIENTIFIC INFORMATION
......................................................................................
16
PHARMACEUTICAL INFORMATION
.............................................................................
16
CLINICAL TRIALS
................................................................