TARO-LATANOPROST SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

LATANOPROST

متاح من:

TARO PHARMACEUTICALS INC

ATC رمز:

S01EE01

INN (الاسم الدولي):

LATANOPROST

جرعة:

50MCG

الشكل الصيدلاني:

SOLUTION

تركيب:

LATANOPROST 50MCG

طريقة التعاطي:

OPHTHALMIC

الوحدات في الحزمة:

2.5ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

PROSTAGLANDIN ANALOGS

ملخص المنتج:

Active ingredient group (AIG) number: 0132916002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2013-11-04

خصائص المنتج

_TARO-LATANOPROST Product Monograph _
_ Page 1 of 28_
PRODUCT MONOGRAPH
PR
TARO-LATANOPROST
Sterile
Latanoprost Ophthalmic Solution, 50 µg/mL
Prostaglandin F
2α
analogue
Taro Pharmaceuticals Inc.
130 East Drive,
Brampton, Ontario, Canada
L6T 1C1
Control Number: 223187
Date of Revision:
January 4, 2019
_TARO-LATANOPROST Product Monograph _
_ Page 2 of 28_
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
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
...............................................................................11
PHARMACEUTICAL INFORMATION
..........................................................................11
CLINICAL TRIALS
..........................................................................................................12
DETAILED PHARM