ALOMIDE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LODOXAMIDE (LODOXAMIDE TROMETHAMINE)

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

S01GX05

INN (International Name):

LODOXAMIDE

Dosage:

0.1%

Pharmaceutical form:

SOLUTION

Composition:

LODOXAMIDE (LODOXAMIDE TROMETHAMINE) 0.1%

Administration route:

OPHTHALMIC

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

ANTIALLERGIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0122561001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-03-23

Summary of Product characteristics

_ _
_ALOMIDE_
_*_
_ Product Monograph _
_Page 1 of 13_
PRODUCT MONOGRAPH
Pr
ALOMIDE
*
Lodoxamide Ophthalmic Solution
0.1 % w/v (as lodoxamide tromethamine)
Anti-allergy Agent
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Preparation:
March 29, 1995
Date of Revision:
March 22, 2017
Submission Control No.: 202728
*
a trademark of Novartis
_ _
_ALOMIDE_
_*_
_ Product Monograph _
_Page 2 of 13_
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
....................................................................................................4
DOSAGE AND ADMINISTRATION
................................................................................5
OVERDOSAGE
..................................................................................................................6
ACTION AND CLINICAL PHARMACOLOGY
..............................................................6
STORAGE AND STABILITY
............................................................................................7
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................7
PART II: SCIENTIFIC INFORMATION
.................................................................................8
PHARMACEUTICAL INFORMATION
............................................................................8
CLINICAL TRIALS
............................................................................................................8
TOXICOLOGY
...........................