APO-BRIMONIDINE-TIMOP SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

BRIMONIDINE TARTRATE; TIMOLOL (TIMOLOL MALEATE)

Beschikbaar vanaf:

APOTEX INC

ATC-code:

S01ED51

INN (Algemene Internationale Benaming):

TIMOLOL, COMBINATIONS

Dosering:

0.2%; 0.5%

farmaceutische vorm:

SOLUTION

Samenstelling:

BRIMONIDINE TARTRATE 0.2%; TIMOLOL (TIMOLOL MALEATE) 0.5%

Toedieningsweg:

OPHTHALMIC

Eenheden in pakket:

5ML/10ML

Prescription-type:

Prescription

Therapeutisch gebied:

BETA BLOCKING AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0249643001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2022-10-31

Productkenmerken

_APO-BRIMONIDINE-TIMOP (brimonidine tartrate and timolol solution) _
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_page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-BRIMONIDINE-TIMOP
brimonidine tartrate / timolol ophthalmic solution
Solution, brimonidine tartrate 0.2% w/v and timolol 0.5% w/v (as
timolol maleate), for
ophthalmic use
Relatively Selective α2-adrenoceptor Agonist and β-adrenergic
Blocking Agent
(ATC Code: S01ED51)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization
October 31, 2011
Date of Revision:
December 14, 2022
Submission Control Number: 267456
_APO-BRIMONIDINE-TIMOP (brimonidine tartrate and timolol solution) _
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_page 2 of 39 _
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
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
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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