XALACOM SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

থেকে পাওয়া:

BGP PHARMA ULC

এটিসি কোড:

S01ED51

INN (আন্তর্জাতিক নাম):

TIMOLOL, COMBINATIONS

ডোজ:

5MG; 50MCG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG

প্রশাসন রুট:

OPHTHALMIC

প্যাকেজ ইউনিট:

2.5ML

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

BETA-ADRENERGIC AGENTS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2003-09-02

পণ্য বৈশিষ্ট্য

_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
.......................................