ACTIKERALL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUOROURACIL; SALICYLIC ACID

Available from:

CIPHER PHARMACEUTICALS INC

ATC code:

L01BC52

INN (International Name):

FLUOROURACIL, COMBINATIONS

Dosage:

0.5%; 10%

Pharmaceutical form:

SOLUTION

Composition:

FLUOROURACIL 0.5%; SALICYLIC ACID 10%

Administration route:

TOPICAL

Units in package:

25ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0255930001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-08-27

Summary of Product characteristics

_ _
_ACTIKERALL Product Monograph _
_Page 1 of 26_
PRODUCT MONOGRAPH
PR
ACTIKERALL
TM
fluorouracil and salicylic acid
Solution (0.5%/10%)
Topical Antineoplastic Agent
Cipher Pharmaceuticals Inc.
2345 Argentia Road, Unit 100A
Mississauga, ON
L5N 8K4
Date of Preparation:
August 7, 2015
Submission Control No: 185418
_ _
_ACTIKERALL Product Monograph _
_Page 2 of 26_
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
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
...............