Emend® I.V. Powder for Solution for Infusion 150mg

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

Fosaprepitant Dimeglumine 245.3mg eqv Fosaprepitant

Tillgänglig från:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC-kod:

A04AD12

Dos:

150.0 mg

Läkemedelsform:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Sammansättning:

Fosaprepitant Dimeglumine 245.3mg eqv Fosaprepitant 150.0 mg

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

Prescription Only

Tillverkad av:

Patheon Manufacturing Services, LLC

Bemyndigande status:

ACTIVE

Tillstånd datum:

2012-05-17

Bipacksedel

SG-PPI-MK0517-IV-062022
Information For The Patient
About EMENDⓇ I.V. Powder for Solution for Infusion
Please read this leaflet carefully before you start to take your
medicine, even if you have just refilled your
prescription. Some of the information in the previous leaflet may have
changed.
Remember that your doctor has prescribed this medicine only for you.
Never give it to anyone else.
What is EMEND I.V.?
EMEND I.V. (fosaprepitant dimeglumine) is to be given intravenously by
your doctor and it contains
150 mg of fosaprepitant
as the active ingredient.
In addition, EMEND I.V. contains the following inactive ingredients:
edetate disodium, polysorbate 80,
lactose anhydrous, sodium hydroxide and/or hydrochloric acid.
EMEND I.V. 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.
Why has my doctor prescribed EMEND I.V.?
Your doctor has prescribed EMEND I.V. for the prevention of nausea and
vomiting associated with your
cancer chemotherapy treatment.
What should I know before taking EMEND I.V.?
Who should not take EMEND I.V.?
Do not take EMEND I.V. if you are allergic to EMEND I.V., aprepitant
or any of its ingredients.
What should I tell my doctor before taking EMEND I.V.?
Tell your doctor about any of the following that apply to you:
•
any past or present medical problems.
•
any allergies.
•
all medicines that you are taking or plan to take, even those you can
get without a
prescription or herbal products.
Use in children
EMEND I.V. has not been approved for use in children.
Use in the elderly
No dosage adjustment is necessary for elderly patients.
Use in pregnancy and breast-feeding
Tell your doctor if you are:
•
Pregnant or plan to become pregnant.
•
Breast-feeding or plan to breast-feed.
Can I take EMEND I.V. with other medicines?
Do not take EMEND I.V. with pimozide, terfenadi

Produktens egenskaper

SG-MK0517-IV-062022
PRODUCT CIRCULAR
Intravenous
EMEND® I.V. Powder for Solution for Infusion
(fosaprepitant dimeglumine)
I. THERAPEUTIC CLASS
EMEND I.V. (fosaprepitant dimeglumine, hereafter referred to as
fosaprepitant), is a prodrug of
aprepitant.
II. CHEMISTRY
Fosaprepitant dimeglumine is a prodrug of aprepitant and is chemically
described as 1-Deoxy-1-
(methylamino)-D-glucitol
[3-[[(2
R
,3
S
)-2-[(1
R
)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-
fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1
H
-1,2,4-triazol-1-yl]phosphonate
(2:1)
(salt).
Its empirical formula is C
23
H
22
F
7
N
4
O
6
P·2(C
7
H
17
NO
5
) and its structural formula is:
N
O
O
CF
3
CF
3
F
N
NH
O
CH
3
O
P
N
HO
HO
H
3
C
H
N
OH
OH
OH
OH
OH
2
.
Fosaprepitant dimeglumine is a white to off-white amorphous powder
with a molecular weight of
1004.83. It is freely soluble in water.
III. COMPOSITION
IIIa. Active Ingredients
Each vial of EMEND I.V. 150 mg for CINV intravenous administration
contains 245.3 mg of
fosaprepitant dimeglumine equivalent to 150 mg of fosaprepitant free
acid.
IIIb.
Inactive Ingredients
Each vial of EMEND I.V. 150 mg for CINV contains the following
inactive ingredients: edetate
disodium, polysorbate 80 (75 mg), lactose anhydrous, sodium hydroxide
and/or hydrochloric
acid (for pH adjustment).
IV. INDICATIONS
EMEND
I.V.
is
indicated
for the
prevention of
acute and delayed nausea and vomiting
associated with initial and repeat courses of:
•
highly emetogenic cancer chemotherapy (see DOSAGE AND ADMINISTRATION)
•
moderately emetogenic cancer chemotherapy (see DOSAGE AND
ADMINISTRATION).
EMEND I.V. should be given in combination with a corticosteroid and a
5-HT
3
antagonist.
V. DOSAGE AND ADMINISTRATION
EMEND I.V. for intravenous administration is a lyophilized prodrug of
aprepitant (EMEND)
containing polysorbate 80 (PS80).
EMEND I.V. 150 mg
EMEND I.V. 150 mg is administered on Day 1 as an infusion over 20 –
30 minutes initiated
approximately 30 minutes prior to chemotherapy. EMEND I.V. should be
administered in
con