XALACOM SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

Dostopno od:

BGP PHARMA ULC

Koda artikla:

S01ED51

INN (mednarodno ime):

TIMOLOL, COMBINATIONS

Odmerek:

5MG; 50MCG

Farmacevtska oblika:

SOLUTION

Sestava:

TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG

Pot uporabe:

OPHTHALMIC

Enote v paketu:

2.5ML

Tip zastaranja:

Prescription

Terapevtsko območje:

BETA-ADRENERGIC AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2003-09-02

Lastnosti izdelka

_XALACOM (latanoprost and timolol) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
XALACOM®
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
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
JUL 21, 2023
Submission Control Number: 277053
®
Viatris Specialty LLC
BGP Pharma ULC, a Viatris company, Licensee
© BGP Pharma ULC, 2023
_ _
_XALACOM (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
.......................................