EMEND 125 MG CAPSULES

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

APREPITANT

Saatavilla:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC-koodi:

A04AD12

Lääkemuoto:

CAPSULES

Koostumus:

APREPITANT 125 MG

Antoreitti:

PER OS

Prescription tyyppi:

Required

Valmistaja:

MERCK SHARP & DOHME LLC, USA

Terapeuttinen ryhmä:

APREPITANT

Terapeuttinen alue:

APREPITANT

Käyttöaiheet:

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 including high-dose cisplatin. - prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Valtuutus päivämäärä:

2021-08-31

Pakkausseloste

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
EMEND
®
80 mg
Capsules
EMEND
®
125 mg
Capsules
Each capsule contains:
Aprepitant 80 mg
Each capsule contains:
Aprepitant 125 mg
For a list of inactive ingredients see section 6 "FURTHER INFOMATION".
See also section 2.9 “Important
information about some of the ingredients of EMEND”.
Read the entire leaflet carefully before you start taking this
medicine.
•
This leaflet contains concise information about the medicine. If you
have any further questions, ask the
doctor or the pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
•
This medicine is not intended for children and adolescents under 18
years of age.
1. WHAT EMEND IS INTENDED FOR?
EMEND capsules are intended for use in adult patients, in combination
with other anti-emetic
medicines:
-
To prevent acute and delayed nausea and vomiting caused by
chemotherapy (cancer treatment) of
highly emetogenic potential (strong trigger of nausea and vomiting).
-
To prevent chemotherapy induced nausea and vomiting (CINV) that are
caused by chemotherapy
(cancer treatment) of moderate emetogenic potential (moderate trigger
of nausea and vomiting).
Therapeutic group: EMEND is a neurokinin 1 (NK
1
) receptor antagonist.
2. BEFORE YOU TAKE EMEND
2.1 Do not take EMEND:
−
if you are hypersensitive (allergic) to aprepitant or any of the other
ingredients of EMEND (for a list
of inactive ingredients, see section 6).
−
with medicines containing pimozide (used to treat psychiatric
illnesses), terfenadine and astemizole
(used for hay fever and other allergic conditions), cisapride (used
for treating digestive problems). Tell
your doctor if you are taking these medicines since your treatment
must be modified before you start
taking EMEND. Taking EMEND with these medications could result in
serious or life-threatening
p

Valmisteyhteenveto

1
1.
NAME OF THE MEDICINAL PRODUCT
EMEND
®
125 mg capsules
EMEND
®
80 mg 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 known effect:
Each capsule contains 80
mg of sucrose (in the 80 mg capsule).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
The 125
mg gelatin capsule (no. 1) is opaque with a white body and pink cap
with “462” and “125
mg” printed radially in black ink on the body. The 80
mg gelatin capsules (no. 2) 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
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, including high-dose
cisplatin (see section 4.2).
•
Prevention of nausea and vomiting associated with initial and repeat
courses of moderately
emetogenic cancer chemotherapy (see section 4.2)
4.2
Posology and method of administration
Posology
EMEND is given for 3 days as part of a regimen that includes 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.
The following regimens are recommended for the prevention of nausea
and vomiting associated with
emetogenic cancer chemotherapy:
2
_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
Dexam