KEPIVANCE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PALIFERMIN

Available from:

SWEDISH ORPHAN BIOVITRUM AB (PUBL)

ATC code:

V03AF08

INN (International Name):

PALIFERMIN

Dosage:

6.25MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

PALIFERMIN 6.25MG

Administration route:

INTRAVENOUS

Units in package:

1ML

Prescription type:

Prescription

Therapeutic area:

CELL STIMULANTS AND PROLIFERANTS

Product summary:

Active ingredient group (AIG) number: 0151563001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-01-30

Summary of Product characteristics

_KEPIVANCE® _
_ _
_ _
_PRODUCT MONOGRAPH _
_ _
_ _
_ _
_ _
_1_
_ _
_(PALIFERMIN) _
_ _
_ NON-ANNOTATED _
_ _
_ _
_ _
PRODUCT MONOGRAPH
Pr
KEPIVANCE
®
(palifermin)
Sterile, Lyophilized Powder for Reconstitution
(6.25 mg/vial)
Intravenous Use Only
Keratinocyte Growth Factor
Swedish Orphan Biovitrum AB (publ)
SE-112 76
Stockholm, Sweden
Imported by:
C.R.I.
4 Innovation Drive
Dundas, Ontario
L9H 7P3
Date of authorization: October 10, 2014
:
Submission Control No.: 158472
_KEPIVANCE® _
_ _
_ _
_PRODUCT MONOGRAPH _
_ _
_ _
_ _
_ _
_2_
_ _
_(PALIFERMIN) _
_ _
_ NON-ANNOTATED _
_ _
_ _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................
3
SUMMARY PRODUCT INFORMATION
............................................................
3
DESCRIPTION....................................................................................................
3
INDICATIONS AND CLINICAL
USE....................................................................
3
CONTRAINDICATIONS
......................................................................................
4
WARNINGS AND
PRECAUTIONS.....................................................................
4
ADVERSE
REACTIONS......................................................................................
6
DRUG
INTERACTIONS.......................................................................................
10
DOSAGE AND
ADMINISTRATION......................................................................
11
OVERDOSAGE
....................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
......................................................
12
STORAGE AND
STABILITY.................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
...............................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................
14
PART II: SCIENTIFIC
INFORMATION..............