APO-LATANOPROST SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LATANOPROST

Tersedia dari:

APOTEX INC

Kode ATC:

S01EE01

INN (Nama Internasional):

LATANOPROST

Dosis:

50MCG

Bentuk farmasi:

SOLUTION

Komposisi:

LATANOPROST 50MCG

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

2.5ML

Jenis Resep:

Prescription

Area terapi:

PROSTAGLANDIN ANALOGS

Ringkasan produk:

Active ingredient group (AIG) number: 0132916002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2017-09-07

Karakteristik produk

1
PRODUCT MONOGRAPH
PR
APO-LATANOPROST
Latanoprost Ophthalmic
Solution
50 mcg/mL Latanoprost
PROSTAGLANDIN F
2Α
ANALOGUE
Apotex Inc.
.
Date of Revision:
150 Signet Drive
August 30, 2017
Toronto, Ontario
M9L 1T9
CONTROL NO.: 207519
2
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....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL
INFORMATION..........................................................................10
CLINICAL TRIALS
..........................................................................................................11
DETAILED PHARMACOLOGY
.....................................................................................12
TOXICOLOGY
....................