APO-OLOPATADINE SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE)

Pieejams no:

APOTEX INC

ATĶ kods:

S01GX09

SNN (starptautisko nepatentēto nosaukumu):

OLOPATADINE

Deva:

0.1%

Zāļu forma:

SOLUTION

Kompozīcija:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE) 0.1%

Ievadīšanas:

OPHTHALMIC

Vienības iepakojumā:

5 ML

Receptes veids:

Prescription

Ārstniecības joma:

ANTIHISTAMINE DRUGS

Produktu pārskats:

Active ingredient group (AIG) number: 0132394001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2012-11-22

Produkta apraksts

PRODUCT MONOGRAPH
PR APO-OLOPATADINE
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION
0.1% (W/V) OLOPATADINE (AS OLOPATADINE HYDROCHLORIDE)
ANTI-ALLERGY AGENT
APOTEX INC.
DATE REVISED
150 SIGNET DRIVE
AUGUST 7, 2018
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 218031
_____________________________________________________________________________________
_APO-OLOPATADINE Ophthalmic Solution Product Monograph _
_Page 2 of 18 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
3
ADVERSE REACTIONS
...........................................................................................................
5
DRUG INTERACTIONS
...........................................................................................................
6
DOSAGE AND ADMINISTRATION
.......................................................................................
6
OVERDOSAGE
.........................................................................................................................
6
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
6
STORAGE AND STABILITY
...................................................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 8
PART II: SCIENTIFIC INFORMATION
................................................................................
9
PHARMACEUTICAL INFORMATION
.................................................................