MYLAN-LATANOPROST/TIMOLOL SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

Dostupné s:

MYLAN PHARMACEUTICALS ULC

ATC kód:

S01ED51

INN (Mezinárodní Name):

TIMOLOL, COMBINATIONS

Dávkování:

5MG; 50MCG

Léková forma:

SOLUTION

Složení:

TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG

Podání:

OPHTHALMIC

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

BETA-ADRENERGIC AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0248501001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2020-05-11

Charakteristika produktu

_MYLAN-LATANOPROST/TIMOLOL (latanoprost and timolol) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-LATANOPROST/TIMOLOL
Latanoprost and timolol ophthalmic solution
Solution, latanoprost 50 mcg/mL and timolol 5 mg/mL as timolol
maleate, Ophthalmic
Prostaglandin F
2α
Analogue and Beta-adrenergic Receptor Blocker
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
NOV 16, 2023
Submission Control Number: 279765
© 2023 Mylan Pharmaceuticals ULC, a Viatris company.
_ _
_MYLAN-LATANOPROST/TIMOLOL (latanoprost and timolol) _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
None at the time of 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
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
...............