SAFLUTAN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TAFLUPROST

Available from:

PURDUE PHARMA

ATC code:

S01EE05

INN (International Name):

TAFLUPROST

Dosage:

4.5MCG

Pharmaceutical form:

SOLUTION

Composition:

TAFLUPROST 4.5MCG

Administration route:

OPHTHALMIC

Units in package:

0.3ML

Prescription type:

Prescription

Therapeutic area:

PROSTAGLANDIN ANALOGS

Product summary:

Active ingredient group (AIG) number: 0155650001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2023-05-18

Summary of Product characteristics

SAFLUTAN™
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SAFLUTAN™
Tafluprost Ophthalmic Solution
Ophthalmic Solution (Preservative-Free), 15 mcg/mL, Ophthalmic
Elevated Intraocular Pressure Therapy
Fluorinated PGF
2α
Analogue
Purdue Pharma
575 Granite Court
Pickering, ON
L1W 3W8
Date of Initial Approval:
November 3, 2016
Date of Revision:
July 29, 2020
Submission Control No: 237802
Saflutan™ is a trademark of Purdue Pharma
SAFLUTAN™
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RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 3
1
INDICATIONS
.................................................................................................................
3
1.1
Pediatrics
.............................................................................................................
3
1.2
Geriatrics
.............................................................................................................
3
2
CONTRAINDICATIONS
..................................................................................................
3
3
DOSAGE AND ADMINISTRATION
................................................................................
3
3.1
Recommended Dose and Dosage Adjustment
..................................................... 3
3.2
Administration
......................................................................................................
3
3.3
Missed Dose
........................................................................................................
4
4
OVERDOSAGE
...............................................................................................................
4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 4
6
WARNINGS AND PRECAUTIONS
.................................................................................
5
6.1
Special Populations
...........................................................................