Emend

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Aprepitant 40mg

Dostupné s:

Merck Sharp & Dohme (New Zealand) Limited

INN (Mezinárodní Name):

Aprepitant 40 mg

Dávkování:

40 mg

Léková forma:

Capsule

Složení:

Active: Aprepitant 40mg Excipient: Hyprolose Micronised sodium lauryl sulphate Opaque white and mustard yellow hard gelatin capsule (contains titanium dioxide, yellow iron) Microcrystalline cellulose Purified water Sodium laurilsulfate Sucrose

Jednotky v balení:

Blister pack, 1 capsule

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Siegfried Evionnaz SA

Terapeutické indikace:

Emend, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: · moderately emetogenic cancer chemotherapy. · highly emetogenic cancer chemotherapy.

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, - 1 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, - 5 capsules - 48 months from date of manufacture stored at or below 30°C

Datum autorizace:

2005-10-20

Informace pro uživatele

EMEND
®
1
EMEND
®
Aprepitant
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EMEND.
It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits.
Your doctor has weighed
the risks of you taking EMEND
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EMEND IS USED
FOR
EMEND, in combination with other
medicines, is used to prevent nausea
(feeling
sick) and vomiting
associated with cancer
chemotherapy.
EMEND belongs to a group of
medicines called neurokinin 1 (NK1)
receptor antagonists.
It works by
blocking the actions of substances in
your brain, called substance P
neurokinins, that cause nausea and
vomiting.
Your doctor may have prescribed
EMEND for
another reason.
Ask
your doctor if you have any questions
about why EMEND has been
prescribed for you.
The safety and effectiveness of
EMEND in children and teenagers
under the age of 18 years have not
been established.
EMEND is not addictive.
BEFORE
YOU TAKE
EMEND
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE EMEND IF YOU HAVE
AN ALLERGY TO EMEND OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT TAKE EMEND IF YOU ARE
TAKING:

Cisapride*, used to treat stomach
reflux

pimozide*, used to treat
psychotic
conditions

terfenadine (Teldane*) and
astemizole (Hismanal*),
antihistamines used for allergic
conditions, including hayfever
* not available in New Zealand

St Johns Wort - a herb used to
treat depression
Taking EMEND with these
medicines may cau
se serious or life-
threatening reactions.
DO NOT TAKE EMEND IF YOU HAVE A
RARE HEREDITARY PROBLEM OF
FRUCTOSE INTOLERANCE, GLUCOSE
-
GALACTOSE MALABSORPTION, OR
SUCROSE-
ISOMALTASE INSUFFICIENCY.
DO NOT TAKE EMEND IF YOU ARE
BREAST-
FEEDING OR PLAN TO BREAST
-
FEED.
It is not known if EMEND pass

Charakteristika produktu

Page
1
of
16
NEW ZEALAND DATA SHEET
1
PRODUCT
NAME
EMEND
®
80 mg and 125
mg and capsule
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 80
mg capsule contains 80 mg of aprepitant
Each 125
mg capsule contains 125 mg of aprepitant
Excipients with known effect
Each 80 mg capsule contains 80 mg of sucrose.
Each 125 mg capsule contains 125 mg sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
80 mg: A size #2 opaque, hard gelatin capsule with white body and
white cap with “461” and
“80 mg” printed radially in black ink. Dimensions are overall
length 18.0 mm.
125 mg: A size #1 opaque, hard gelatin capsule with white body and
pink cap with “462” and
“125 mg” printed radially in black ink. Dimensions are overall
length 19.4 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EMEND, in combination with other antiemetic agents, is indicated for
the prevention of acute
and delayed nausea and
vomiting associated with
initial and repeat courses of:

highly emetogenic cancer chemotherapy (see
Section 4.2
)

moderately emetogenic cancer chemotherapy (see
Section 4.2).
4.2
DOSE AND METHOD OF ADMINISTRATION
EMEND (aprepitant) is available as capsules
for oral administration.
EMEND is given for 3 days as part of a regimen that includes a
corticosteroid
and a 5-HT3
antagonist. The
data sheet
for the co
-
administered 5
-
HT3 antagonist (e.g., ondansetron) must
be consulted prior to initiation of treatment with EMEND.
The recommended dose of EMEND for the 3
-
day oral regimen is 125 mg orally 1 hour prior to
chemotherapy treatment (Day 1) and 80 mg orally once daily in the
morning on Days
2 and 3.
Page
2
of
16
Recommended
dosing for the
prevention
of nausea and vomiting associated with highly
emetogenic cancer chemotherapy:
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
antagonist
(e.g., ondansetron)
See the data sheet for the
selected 5-HT
3
antagonist
for appropriate dosing
info