Emend

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Aprepitant 165mg

Disponibbli minn:

Merck Sharp & Dohme (New Zealand) Limited

INN (Isem Internazzjonali):

Aprepitant 165 mg

Dożaġġ:

165 mg

Għamla farmaċewtika:

Capsule

Kompożizzjoni:

Active: Aprepitant 165mg Excipient: Gelatin   Hyprolose Indigo carmine Microcrystalline cellulose as beads Sodium laurilsulfate Sucrose Titanium dioxide  

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Siegfried Evionnaz SA

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Blister pack, Cold form Al/polyamide blisters with either laquered Al foil or laminated Al/polyester/paper lidding - 1 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, Cold form Al/polyamide blisters with either laquered Al foil or laminated Al/polyester/paper lidding - 6 capsules - 48 months from date of manufacture stored at or below 30°C

Data ta 'l-awtorizzazzjoni:

2012-11-28

Fuljett ta 'informazzjoni

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
_CHEMOTHERAPY INDUCED _
_NAUSEA AND VOMITING _
EMEND, in combination with other
medicines, is used to prevent nausea
(feeling sick) and vomiting
associated with cancer
chemotherapy.
_POST-OPERATIVE NAUSEA AND _
_VOMITING _
EMEND is used to prevent nausea
(feeling sick) and vomiting which
can occur after surgery.
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 cause serious or life-
threatening reactions.
DO NOT TAKE EMEND IF YOU HAVE A
RARE HEREDITARY PROBLEM OF
FRUCTOSE IN

Karatteristiċi tal-prodott

Page 1 of 19
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
EMEND
®
40 mg, 80 mg, 125 mg, and 165 mg capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 40 mg capsule contains 40 mg of aprepitant
Each 80 mg capsule contains 80 mg of aprepitant
Each 125 mg capsule contains 125 mg of aprepitant
Each 165 mg capsule contains 165 mg of aprepitant
_Excipients with known effect _
Each 40 mg capsule contains 40 mg of sucrose.
Each 80 mg capsule contains 80 mg of sucrose.
Each 125 mg capsule contains 125 mg sucrose.
Each 165 mg capsule contains 165 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
40 mg: A size #4 opaque, hard gelatin capsule with white body and
mustard yellow cap with
“464” and “40 mg” printed radially in black ink. Dimensions
are overall length 14.3 mm.
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.
165 mg: A size #0 opaque. Hard gelatin capsule with a white body and
light blue cap with
“466” and “165 mg” printed radially in black ink. Dimensions
are overall length 21.7 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).
EMEND is indicated for the prevention of postoperative nausea and
vomiting.
Page 2 of 19
4.2
DOSE AND METHOD OF ADMINISTRATION
PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV)
EMEND (aprepitant) is available as capsules for oral administration.
EMEND is given for 1 day or for 3 days as part of a regimen that
includes a corticosteroi