SANDOZ LATANOPROST/TIMOLOL SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

LATANOPROST; TIMOLOL (TIMOLOL MALEATE)

Dostupné s:

SANDOZ CANADA INCORPORATED

ATC kód:

S01ED51

INN (Mezinárodní Name):

TIMOLOL, COMBINATIONS

Dávkování:

50MCG; 5MG

Léková forma:

SOLUTION

Složení:

LATANOPROST 50MCG; TIMOLOL (TIMOLOL MALEATE) 5MG

Podání:

OPHTHALMIC

Jednotky v balení:

2.5ML

Druh předpisu:

Prescription

Terapeutické oblasti:

BETA-ADRENERGIC AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0248501002; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2019-04-26

Charakteristika produktu

_Sandoz Latanoprost/Timolol _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR SANDOZ LATANOPROST/TIMOLOL
Latanoprost and timolol ophthalmic solution, 50 mcg/mL / 5 mg/mL (as
timolol maleate)
Elevated Intraocular Pressure Therapy
Prostaglandin F
2α A
nalogue and Beta-adrenergic Receptor Blocker
Sandoz Canada Inc.
Date of Preparation:
145 Jules-Léger
December 28, 2017
2017
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 211248
_ _
_Sandoz Latanoprost/Timolol _
_Page 2 of 31_
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
...........