Emend
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
08-03-2024
Charakterystyka produktu
(SPC)
08-03-2024
Sprawozdanie z oceny publicznego
(PAR)
17-03-2021
Składnik aktywny:
Aprepitant
Dostępny od:
Merck Sharp & Dohme B.V.
Kod ATC:
A04AD12
INN (International Nazwa):
aprepitant
Grupa terapeutyczna:
Antiemetics and antinauseants,
Dziedzina terapeutyczna:
Vomiting; Postoperative Nausea and Vomiting; Cancer
Wskazania:
Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics).Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.
Podsumowanie produktu:
Revision: 30
Status autoryzacji:
Authorised
Data autoryzacji:
2003-11-11
Ulotka dla pacjenta
58
B. PACKAGE LEAFLET
59
PACKAGE LEAFLET: INFORMATION FOR TH
E USER
EMEND 125
MG HARD CAPSULES
EMEND 80
MG HARD CAPSULES
aprepitant
READ ALL OF THIS LEAF
L
ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU. IF YOU ARE THE PARENT OF A CHILD TAKING
EMEND, PLEASE READ
THIS
INFORMATION CAREFULLY
.
-
Keep this leaflet. You may need to read it again.
-
If you have
a
ny further questions, ask the doctor, pharmacist, or nurse.
-
This medicine has been prescribed for you or the child only. Do not
pass it on to others. It may
ha
rm them, even if their signs of illness are the same.
-
If you or the child gets any side effe
c
ts, talk to your doctor, pharmacist, or nurse. This includes
any possible
side effects not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET
1.
Wh
at EMEND is and what it is used for
2.
What you need to know before you take or give EMEND
3.
H
ow to take EMEND
4.
Possible side effects
5.
How to store EMEND
6.
Contents of the pack and other
information
1.
WHAT EMEND IS AND WHAT IT IS USED FOR
EMEND c
ontains the active substance aprepitant and belongs to a group of
medicines called
"neurokinin 1 (NK
1
) receptor antagonists". The brain has a specific area that controls
nausea and
vomiting. EMEND works by blocking signals to that area, thereby
reducing na
usea and vomiting.
EMEND capsules are used in adults and adolescents from the age of 12
years I
N COMBINATION WITH
OTHER MEDICINES
to prevent nausea and vomiting caused by chemotherapy (cancer
treatment)
that are
strong and moderate triggers of nausea and v
omiting (such as cisplatin, cyclophosphamide,
doxorubicin or epirubicin)
.
2.
WHAT YOU NEED T
O
KNOW BEFORE YOU TAKE
OR GIVE EMEND
DO NOT TAKE EMEND
-
if you or the child is allergic to aprepitant or any of the other
ingredients of this medicine (listed
in section 6).
-
with medicines containing pimozide (used to treat psychiatric
illnesses), terfenad
ine and
astemizole (used for hay fever and other allergic conditions),
cisapride (used fo
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EMEND 125
mg hard capsules
EMEND 80
mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 125
mg capsule contains 125
mg of aprepitant
. Each 80
mg capsule contains 80
mg of aprepitant.
Excipient with known effect
Each
capsule contains 125
mg of sucrose
(in the 125
mg capsule)
.
Excipient with kn
own effect
Each
capsule contains
80 mg of sucrose (in the 80 mg capsule).
For the full list
o
f excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
The 125
mg capsule is opaque with a white body a
n
d pink cap with “462” and “125
mg” printed
radially in black ink on the b
ody. The 80 m
g capsules are opaque with a white body and cap
with
“461” and “80
mg” printed radially in black ink on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention nausea and vomiting associated with highly and moderately
emet
ogenic cancer
chemotherapy in adults and adolescents from th
e age of 12.
EMEND 125
mg/80
mg is given as part of combination therapy (see section
4.2).
4.2
POSOLOGY AND METHOD OF AD
MINISTRATION
Posology
Adults
EMEND is given for 3
days as part of a regim
en that inclu
des a corticosteroid and a 5
-HT
3
antagonist.
The
recommended dose is 125
mg orally once daily one hour before start of chemotherapy on Day
1
and 80
mg orally once daily
on Days 2 and
3 in the morning
.
3
The following regimens are
recommended in
adults for t
he prevention of nausea and vomiting
associated w
ith emetogenic cancer chemotherapy:
Highly Emetogenic Chemotherapy Regimen
Day 1
Day 2
Day 3
Day 4
EMEND
125 mg orally
80 mg orally
80 mg orally
none
Dexamethasone
12 mg orally
8 mg orally
8 mg orally
8 mg orally
5-HT
3
antagonists
Standard dose of
5-HT
3
antagonists.
See the product
information for the
selected 5-HT
3
antagonist for
appropriate dosing
information
none
none
none
DEXAMETHASONE
should be administered 30
minutes prior to chemothe
rapy treatmen
t on Day 1 and in
the morning on Days
2 to 4. The
dose of
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