Ivemend

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

fosaprepitant

Fáanlegur frá:

Merck Sharp & Dohme B.V.

ATC númer:

A04AD12

INN (Alþjóðlegt nafn):

fosaprepitant

Meðferðarhópur:

Antiemetics and antinauseants,

Lækningarsvæði:

Vomiting; Cancer

Ábendingar:

Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older.Ivemend 150 mg is given as part of a combination therapy.

Vörulýsing:

Revision: 24

Leyfisstaða:

Authorised

Leyfisdagur:

2008-01-11

Upplýsingar fylgiseðill

28
B.
PACKAGE LEAFLET
29
PACKAGE L
EAFLET: INFORMATION FOR THE USER
IVEMEND 150
MG POWDER FOR SOLUTION FOR INFUSION
fosaprepitant
READ A
LL OF THIS LEAFLET CAREFULLY BEFORE YOU STA
RT USING THIS MEDICINE
BECAUSE IT
CONTAINS
IMP
ORTANT INFORMA
TION FOR YOU
.
-
Kee
p this leaflet. You may need
to read it again.
-
If you have any f
urther questions, ask
your
doctor, pharmacist, or nurse.
-
If you ge
t any side effects,
talk to your doctor, pharmacist, or nurse.
This includes
any possible
side effects
not listed in th
is leaflet.
See section 4.
WHAT IS I
N THIS LEAFLET
1.
What IVEMEND i
s and what it is used for
2.
What you need to know
before you use IVEMEND
3.
How to use IVEMEND
4.
Possible side effects
5.
Ho
w to store IVEMEND
6.
Contents
of the pack a
nd other information
1.
W
HAT IVEMEND IS AND WHA
T IT IS USED FOR
IVEMEND contains th
e active substance fosaprepitant which is converted to aprepitant in
your body.
It belongs to a group of medici
nes called "neu
rokinin 1 (NK
1
) receptor antago
nists". The b
rain has a
specific
area that controls nausea and
vomiting. IVEMEND works by blocking
signals to that area,
thereby reducing nausea and vomiting. IVEMEND
is used in adults
, adolescents, and childre
n aged
6 months or older IN COMBINATION WITH O
THER MEDICINE
S
to prevent nau
sea
and vomiting caused by
chemot
herapy (cancer treatment)
that is a strong or
moderate trigger of nausea and vomiting
.
2.
WHAT YOU NEED
TO KNOW BEFORE YOU USE
IVEMEND
DO NOT USE IVEMEND
•
if yo
u are allergic to f
osaprepitan
t
, aprepitant,
or to polysorbat
e 8
0 or any of the other
ingredients
of this medicine
(listed in sec
tion 6).
•
with medicines containing pimozide (used to treat psychiatric
illnesses), te
rfenadine and
astemizole (u
sed for hay fever and othe
r all
ergic conditions),
cisapride (u
sed for treat
ing
digestive problems). Tell
your
doctor if you are taking these me
dicines since
the
treatment must
be modified before you start using IVEMEND.
WARNINGS
AND PRECAUTIONS
Talk to your
doctor, pharmacist, or
nurs
e be

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IVEMEND 150
mg powder for solu
tion
for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains fosaprepitant dimeglumine equivalent t
o 150
mg fosaprepitant,
which corresponds
to 130.5
mg of aprepitant. After reconstitution and dilution 1
ml of solution contains 1
mg
fosa
prepitant (1
mg/ml) (see section
6.6).
For t
he full list of excipients, see section
6.1.
3.
PHARMACEUTICAL FOR
M
Po
wder for solution for infusion.
White to off
-
white amorphous powd
er.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of nausea and vomiting associated with highly
a
nd moderately emetogenic cancer
chemother
apy in adults
and paediatri
c patients aged 6
months and older
.
IVEMEND 150
mg is given as part o
f a com
bination therapy (see section
4.2).
4.2
POSOLOGY
AND METHOD OF ADMINISTRATION
Posology
Adults
The recommend
ed dose is 150
mg administered as an infusi
on
OVER 20-30 MINUTES
on Day 1, initiated
approximately 30
minutes prior to chemotherapy (see sec
tion 6.
6). IVEMEND should be administered
in conjunction
with a corticosteroid and a 5
-HT
3
antagonist as specified i
n
the tables below.
3
The following regimens are recommended for the p
reven
tion of nausea and vomiting associated with
emetogenic cancer che
motherapy.
TABLE 1:
RECOMMENDED DOSING FOR T
HE PREVENTIO
N OF NAUSEA AND VOMITING ASSOCIATED
WITH HIGHLY EMETOGENIC
CH
EMOTHERAPY REGIMEN IN ADULTS
DAY 1
DAY 2
DAY 3
DAY 4
IVEMEND
150 mg
intravenously
none
none
none
Dexamethasone
12 mg orally
8 mg orally
8 MG
ORALLY TWICE
DAILY
8
MG ORALLY TWICE
DAILY
5-HT
3
antagonists
Standard dose of
5-HT
3
antagonists.
See the product
information for the
selected 5-HT
3
antagonist for
appropriate dos
ing
information
none
none
none
DEXAMETHASONE
should be administered 3
0 minut
es prior to chemotherapy treatment on
Day 1 and in
the morning on Days
2 to
4. Dexamethasone should also be a
dm
inistered in the evenings on
Days 3 and 4
. The dose of dexamethasone
acco
unts f