Kepivance
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
08-04-2016
Produktets egenskaber
(SPC)
08-04-2016
Offentlige vurderingsrapport
(PAR)
08-04-2016
Aktiv bestanddel:
palifermin
Tilgængelig fra:
Swedish Orphan Biovitrum AB (publ)
ATC-kode:
V03AF08
INN (International Name):
palifermin
Terapeutisk gruppe:
All other therapeutic products
Terapeutisk område:
Mucositis
Terapeutiske indikationer:
Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.
Produkt oversigt:
Revision: 19
Autorisation status:
Withdrawn
Autorisation dato:
2005-10-25
Indlægsseddel
19
B. PACKAGE LEAFLET
Medicinal product no longer authorised
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
KEPIVANCE 6.25 MG POWDER FOR SOLUTION FOR INJECTION
palifermin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Kepivance is and what it is used for
2.
What you need to know before you use Kepivance
3.
How to use Kepivance
4.
Possible side effects
5.
How to store Kepivance
6.
Contents of the pack and other information
1.
WHAT KEPIVANCE IS AND WHAT IT IS USED FOR
Kepivance contains the active substance palifermin which is a protein
produced by biotechnology in a
bacteria called
_Escherichia coli_
. Palifermin stimulates the growth of specific cells called epithelial
cells that form the tissue lining of your mouth and digestive tract,
as well as other tissues such as skin.
Palifermin works in the same way as keratinocyte growth factor (KGF)
which is made naturally by
your body in small amounts.
Kepivance is used to treat oral mucositis (soreness, dryness and
inflammation of the mouth) which
has occurred as a side effect of treatments for your blood cancer.
To treat your blood cancer you may be receiving chemotherapy,
radiotherapy and autologous
hematopoietic stem cell transplantation (cells from your own body that
produce blood cells). One of
the side effects of these treatments is oral mucositis. Kepivance is
used to reduce the frequency,
duration and severity of oral mucositis symptoms.
Kepivance should only be used in adults over the age of 18 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KEPIVANCE
_ _
DO NOT USE KEPIVANCE:
-
if you are allergic to palifermin,
_Escherichia coli_
derived proteins or any other ingredients of
this medic
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS_ _
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Kepivance 6.25 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6.25 mg of palifermin.
Palifermin is a human keratinocyte growth factor (KGF), produced by
recombinant DNA technology
in
_Escherichia coli_
.
Once reconstituted, Kepivance contains 5 mg/ml of palifermin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection).
White lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kepivance is indicated to decrease the incidence, duration and
severity of oral mucositis in adult
patients with haematological malignancies receiving myeloablative
radiochemotherapy associated
with a high incidence of severe mucositis and requiring autologous
haematopoietic stem cell support.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kepivance treatment should be supervised by a physician experienced in
the use of anti-cancer
therapy.
Posology
_Adults _
The recommended dosage of Kepivance is 60 micrograms/kg/day,
administered as an intravenous
bolus injection for three consecutive days before and three
consecutive days after myeloablative
radiochemotherapy for a total of six doses. The duration between last
dose of Kepivance before
myeloablative radiochemotherapy and the first dose of Kepivance after
myeloablative
radiochemotherapy should be at least seven days.
_Pre-_
_myeloablative radiochemotherapy:_
The first three doses should be administered prior to myeloablative
_ _
therapy, with the third
dose 24 to 48 hours before myeloablative
_ _
radiochemotherapy.
_Post-_
_myeloablative radiochemotherapy: _
The last three doses should be administered post myeloablative
_ _
radiochemotherapy; the first of these
doses should be administered after, but on the same day of
haematopoietic stem cell infusion and at
least seven days after the most recent Kepivance administration (se
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