MYLAN-TIMOLOL SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TIMOLOL (TIMOLOL MALEATE)

Dostupné z:

MYLAN PHARMACEUTICALS ULC

ATC kód:

S01ED01

INN (Medzinárodný Name):

TIMOLOL

Dávkovanie:

0.25%

Forma lieku:

SOLUTION

Zloženie:

TIMOLOL (TIMOLOL MALEATE) 0.25%

Spôsob podávania:

OPHTHALMIC

Počet v balení:

5ML/10ML

Typ predpisu:

Prescription

Terapeutické oblasti:

BETA-ADRENERGIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0131275001; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2012-10-19

Súhrn charakteristických

PRODUCT MONOGRAPH
PR
MYLAN-TIMOLOL
(Timolol Maleate Ophthalmic Solution)
Ophthalmic Solution 0.25% and 0.5%
USP
Elevated Intraocular Pressure Therapy
Mylan Pharmaceuticals ULC
DATE OF REVISION
:
85 Advance Road
JULY 20, 2010
Etobicoke, Ontario
M8Z 2S6
CONTROL # 137993
2
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…………………………………………………….
9
OVERDOSAGE……………………………………………………………………….
10
ACTION AND CLINICAL
PHARMACOLOGY…………………………………………. 10
STORAGE AND
STABILITY…………………………………………………………..
11
DOSAGE FORMS, COMPOSITION AND
PACKAGING………………………………. 11
PART II: SCIENTIFIC INFORMATION
……………………………………………
13
PHARMACEUTICAL
INFORMATION…………………………………………………..
13
CLINICAL
TRIALS……………………………………………………………………..
13
DETAILED
PHARMACOLOGY……………………………………………………….
14
TOXICOLOGY………………………………………………………………………..
14
BIBLIOGRAPHY………………………………………………………………………
17
PART III: CONSUMER INFORMATION
…………………………………………….. 19
3
PR
MYLAN-TIMOLOL
Timolol Maleate Ophthalmi