EMEND IV fosaprepitant 150mg (as fosaprepitant dimeglumine) powder for injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

fosaprepitant dimeglumine, Quantity: 257.6 mg (Equivalent: fosaprepitant, Qty 150 mg)

Sẵn có từ:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (Tên quốc tế):

Fosaprepitant dimeglumine

Dạng dược phẩm:

Injection, powder for

Thành phần:

Excipient Ingredients: disodium edetate; sodium hydroxide; hydrochloric acid; polysorbate 80; lactose

Tuyến hành chính:

Intravenous

Các đơn vị trong gói:

1 vial

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

EMEND IV, 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 Dosage and Administration); - moderately emetogenic cancer chemotherapy (see Dosage and Administration).

Tóm tắt sản phẩm:

Visual Identification: White to off-white solid.; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2011-03-18

Tờ rơi thông tin

EMEND
® IV
_Fosaprepitant dimeglumine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EMEND IV. 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 using EMEND IV
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EMEND IV IS
USED FOR
CHEMOTHERAPY INDUCED NAUSEA
AND VOMITING
EMEND IV, in combination with
other medicines, is used to prevent
•
nausea (feeling sick) and
vomiting associated with cancer
chemotherapy.
EMEND IV 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 IV for another reason. Ask
your doctor if you have any questions
about why EMEND IV has been
prescribed for you.
The safety and effectiveness of
EMEND IV in children and
teenagers under the age of 18 years
have not been established.
EMEND IV is not addictive.
BEFORE YOU ARE GIVEN
EMEND IV
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE EMEND IV IF YOU HAVE
AN ALLERGY TO EMEND IV,
APREPITANT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT USE EMEND IV 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 Australia
•
St John's Wort - a herb used to
treat depression
Using EMEND IV with these
medicines may cause serious or life-
threatening reactions.
DO NOT USE EMEND IV IF YOU ARE
BREAST-FEEDING OR PLAN TO BREAST-
FEED.
It is not known if EMEND IV passes
into breast milk. You and your docto

Đặc tính sản phẩm

Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
EMEND IV
(FOSAPREPITANT)
1
NAME OF THE MEDICINE
Fosaprepitant dimeglumine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of EMEND IV 150 mg for intravenous administration contains
245.3 mg of
fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant free
acid.
List of excipients with known effect:
- lactose monohydrate
For the full list of Excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
EMEND IV (fosaprepitant dimeglumine) is a white to off white solid
powder for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EMEND IV, 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 DOSE AND METHOD
OF
ADMINISTRATION)
•
moderately emetogenic cancer chemotherapy (see SECTION 4.2 DOSE AND
METHOD OF
ADMINISTRATION).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE RECOMMENDATIONS
EMEND IV, for administration by intravenous infusion, is a lyophilised
prodrug of aprepitant
(EMEND) containing polysorbate 80 (PS80).
EMEND IV 150 MG
EMEND IV 150 mg is administered on Day 1 as an infusion OVER 20-30
MINUTES initiated
approximately 30 minutes prior to chemotherapy. EMEND IV should be
administered in
conjunction with a corticosteroid and a 5-HT
3
antagonist as specified in the tables below. The
package insert for the co-administered 5-HT
3
antagonist must be consulted prior to initiation
of treatment with EMEND IV 150 mg.
Page 2 of 17
Table 1: Recommended dosing for the prevention of nausea and vomiting
associated with
highly emetogenic cancer chemotherapy
Day 1
Day 2
Day 3
Day 4
EMEND IV
150 mg IV
none
none
none
Dexamethasone**
12 mg orally
8 mg orally
8 mg orally bid
8 mg orally bid
5-HT
3
antagonist
See the package
insert for the
selected 5-HT
3
antagonist for
appropriate
dosing
information.
none
none
none
** Dexamethasone should be administered 30 minutes prior to
chemotherapy t