ACTIKERALL SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

FLUOROURACIL; SALICYLIC ACID

Inapatikana kutoka:

CIPHER PHARMACEUTICALS INC

ATC kanuni:

L01BC52

INN (Jina la Kimataifa):

FLUOROURACIL, COMBINATIONS

Kipimo:

0.5%; 10%

Dawa fomu:

SOLUTION

Tungo:

FLUOROURACIL 0.5%; SALICYLIC ACID 10%

Njia ya uendeshaji:

TOPICAL

Vitengo katika mfuko:

25ML

Dawa ya aina:

Prescription

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2015-08-27

Tabia za bidhaa

_ _
_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
...............