CROMOLYN EYE DROPS SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CROMOLYN SODIUM

Available from:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC code:

S01GX01

INN (International Name):

CROMOGLICIC ACID

Dosage:

2%

Pharmaceutical form:

SOLUTION

Composition:

CROMOLYN SODIUM 2%

Administration route:

OPHTHALMIC

Units in package:

12.5ML

Prescription type:

OTC

Therapeutic area:

ANTIALLERGIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0108810004; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-11-02

Summary of Product characteristics

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_CROMOLYN EYE DROPS _
_Page 1 of 20_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CROMOLYN EYE DROPS
Cromolyn Sodium Ophthalmic Solution
2% w/v
USP
Anti-allergic Agent
PENDOPHARM, DIVISION OF PHARMASCIENCE INC
.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Revision:
September 14, 2021
Submission Control Number:
252415
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_CROMOLYN EYE DROPS _
_Page 2 of 20_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
4.2
Recommended Dose and Dosage
Adjustment.......................................................4
4.4
Administration.....................................................................................................5
4.5
Missed Dose
........................................................................................................5
5
OVERDOSAGE
...............................................................................................................5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
...................................5
7
WARNINGS AND PRECAUTIONS
....................................................................................6