EMEND COMBI PACK CAPSULES

Šalis: Pietų Afrika

kalba: anglų

Šaltinis: South African Health Products Regulatory Authority (SAHPRA)

Prieinama:

MSD (Pty) Ltd

Dozė:

See ingredients

Vaisto forma:

CAPSULES

Sudėtis:

EACH PACK CONTAINS APREPITANT A

Autorizacija statusas:

Registered

Leidimo data:

2006-11-09

Pakuotės lapelis

PRODUCT NAME: EMEND 80 AND 125 CAPSULES
AND COMBIPACK
COMPONENT: ENGLISH PATIENT INFORMATION
LEAFLET
DATE APPROVED: 10 JUNE 2016
JL20160610
Page 1 of 8
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
EMEND
®
80 Capsules
EMEND
®
125 Capsules
EMEND
®
Combi Pack Capsules
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING EMEND

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

EMEND has been prescribed for you personally and you should not share
your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
1.
WHAT EMEND CONTAINS
EMEND (aprepitant MSD) is a capsule that contains either 125 mg, or 80
mg of aprepitant as the
active ingredient.
In addition, EMEND contains the following inactive ingredients:
Hydroxypropyl cellulose,
microcrystalline cellulose, sodium lauryl sulphate, sucrose, gelatin
capsule and black ink.
S4
PRODUCT NAME: EMEND 80 AND 125 CAPSULES
AND COMBIPACK
COMPONENT: ENGLISH PATIENT INFORMATION
LEAFLET
DATE APPROVED: 10 JUNE 2016
JL20160610
Page 2 of 8
2.
WHAT EMEND IS USED FOR
EMEND is a member of a class of medicines called neurokinin 1 (NK
1
) receptor antagonists that is
used along with other medicines to prevent and control nausea (sick
feeling in the back of throat and
stomach) and vomiting (throwing up) caused by your cancer chemotherapy
treatment.
Your doctor has prescribed EMEND for the prevention of nausea and
vomiting associated with your
cancer chemotherapy treatment.
3.
BEFORE YOU TAKE EMEND
DO NOT TAKE EMEND:

If you are hypersensitive (allergic) to aprepitant or any of the other
ingredients of EMEND.
TAKE SPECIAL CARE WITH EMEND
Tell your doctor about any of the following that apply to you:

If you have or have had any past or present medical problems.

If you have any allergies.

If you are taking or plan to take any medicine, including those you
can get without a prescription
or herbal products.
USE IN CHILDREN

Prekės savybės

PRODUCT NAME: EMEND 80 AND 125
CAPSULES AND COMBIPACK
COMPONENT: ENGLISH PACKAGE INSERT
DATE APPROVED: 10 JUNE 2016
JL20160610
Page 1 of 24
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
EMEND
®
80 mg Capsules
EMEND
®
125 mg Capsules
EMEND
®
Combi Pack Capsules
COMPOSITION
Each capsule contains 80 mg or 125 mg Aprepitant.
EMEND capsules contain sucrose.
INACTIVE INGREDIENTS: Hydroxypropyl cellulose, sodium lauryl sulphate,
sucrose, microcrystalline
cellulose, gelatin capsule and black ink.
PHARMACOLOGICAL CLASSIFICATION
A.5.7.2 Anti-emetics and antivertigo preparations
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
EMEND (aprepitant MSD) is a substance P neurokinin 1 (NK
1
) receptor antagonist.
S4
PRODUCT NAME: EMEND 80 AND 125
CAPSULES AND COMBIPACK
COMPONENT: ENGLISH PACKAGE INSERT
DATE APPROVED: 10 JUNE 2016
JL20160610
Page 2 of 24
Aprepitant is a selective high affinity antagonist at human substance
P neurokinin 1 (NK
1
)
receptors. Counter-screening assays showed that aprepitant was at
least 3 000-fold selective
for the NK
1
receptor over other enzyme, transporter, ion channel and receptor
sites including the
dopamine and serotonin receptors that are targets for existing
Chemotherapy Induced Nausea
and Vomiting (CINV) therapies.
NK
1
-receptor antagonists have been shown pre-clinically to inhibit emesis
induced by cytotoxic
chemotherapeutic agents, such as cisplatin, via central actions.
Pre-clinical and human Positron
Emission Tomography (PET) studies with aprepitant have shown that it
is brain penetrant and
occupies brain NK
1
receptors. Pre-clinical studies show that aprepitant has a long
duration of
central activity, inhibits both the acute and delayed phases of
cisplatin-induced emesis, and
augments the anti-emetic activity of the 5-HT
3
-receptor antagonist ondansetron and the
corticosteroid dexamethasone against cisplatin-induced emesis.
PHARMACOKINETIC PROPERTIES
ABSORPTION
The mean absolute oral bioavailability of aprepitant is approximately
60 to 65 % and the mean
peak plasma concentrati