ETHYOL Amifostine (as trihydrate) 500mg powder for injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

amifostine, Quantity: 500 mg

Tilgjengelig fra:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

Amifostine

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients:

Administreringsrute:

Intravenous

Enheter i pakken:

3 x 10mL, 6 x 10mL, 1 x 10mL, 5 x 10mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

To decrease the incidence of neutropenia related fever and infection induced by DNA-binding chemotherapeutic agents (classical alkylating agents such as cyclophosphamide and non-classical alkylating agents such as mitomycin-C and platinum-containing drugs); decrease in the incidence of acute and cumulative nephrotoxicity associated with platinum-based therapy; and the provision of better adherence to these types of chemotherapy regimens. INDICATIONS AS AT 31 MARCH 2000: Ethyol is indicated to decrease the incidence of neutropenia-related fever and infection induced by DNA-binding chemotherapeutic agents (classical alkylating agents such as cyclophosphamide and non-classical alkylating agents such as mitomycin-C and platinum containing drugs); decrease the incidence of acute and cumulative nephrotoxicity associated with platinum-based therapy; and to provide better adherence to these types of chemotherapy regimens. Ethyol is also indicated to protect against acute and late xerostomia associated with standard fractionated radiation therapy in patients with head and neck cancer.

Produkt oppsummering:

Visual Identification: White cake or powder; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1998-04-16

Informasjon til brukeren

ETHYOL
®
_amifostine_
CONSUMER MEDICINE INFORMATION
ETHYOL
®
INJECTION
1
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ETHYOL. It does not
contain all of 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 being given ETHYOL against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ETHYOL IS USED
FOR
ETHYOL is used to protect you from
some of the side effects caused by
radiation therapy and drugs used to
treat cancer such as
cyclophosphamide, mitomycin-C and
platinum-containing drugs. By
reducing the risk of experiencing these
side effects, it may increase your
likelihood to continue or complete
your chemotherapy regimen.
ETHYOL does not treat cancer.
Since anti-cancer drugs can reduce the
number of white blood cells in your
body, you may get an infection or
fever. ETHYOL helps prevent you
from getting infection and fever
following the administration of certain
anti-cancer drugs.
ETHYOL is also used to protect the
kidneys from being damaged during
treatment with platinum-containing
drugs.
ETHYOL can reduce the risk and
severity of a side effect called
xerostomia in patients receiving
radiation therapy for cancer to the
head and neck. Xerostomia causes
the mouth to be very dry and often
painful which can affect speech and
eating.
Your doctor, however, may prescribe
ETHYOL for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ETHYOL HAS
BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
ETHYOL
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT USE ETHYOL IF:
•
you are allergic to ETHYOL
(amifostine) or aminothiol
compounds
•
you have low blood pressure
•
you are pregnant or
breastfeeding
•
you are dehydrated
•
you are a child or an adult older
than 70

Preparatomtale

1
PRODUCT INFORMATION
ETHYOL
®
INJECTION
NAME OF THE MEDICINE
Amifostine
Chemical structure:
NH
2
(CH
2
)
3
NH(CH
2
)
2
SPO
3
H
2
CAS number:
CAS-20537-88-6
DESCRIPTION
Each vial of ETHYOL Lyophilised Powder for Injection contains 500 mg
of amifostine (anhydrous).
ETHYOL does not contain any preservative.
ETHYOL Powder for Injection is a sterile lyophilised powder. The 500
mg vial is reconstituted with
9.7 mL
of
sterile
0.9%
sodium
chloride
solution
(final
reconstituted
volume
of
10
mL)
before
intravenous infusion.
PHARMACOLOGY
Amifostine
(ethanethiol,
2-[(3-aminopropyl)amino]-dihydrogen
phosphate
(ester))
is
an
organic
thiophosphate which, in animal models, selectively protects normal
tissues but not tumours against
cytotoxicity of ionising radiations, DNA-binding chemotherapeutic
agents (classical alkylating agents
such as cyclophosphamide and non-classical alkylating agents such as
mitomycin-C and platinum-
containing drugs).
Amifostine is a prodrug that is dephosphorylated to the active
metabolite, WR-1065 (free thiol), by
alkaline phosphatase and exits the bloodstream rapidly.
PHARMACOKINETICS
Clinical pharmacokinetic studies have shown that amifostine is rapidly
cleared from the plasma with
<10% remaining in the plasma 6 minutes after drug administration.
Amifostine is rapidly metabolised
into the active metabolite WR-1065 (free thiol). WR-33278 (disulfide)
is the subsequent inactive
metabolite. It is unknown if amifostine crosses the blood placenta
barrier.
After a 15-minute infusion of a dose of 910 mg/m
2
, the distribution half-life is <1 minute, the
elimination half-life of amifostine is <10 minutes.
During
a
15-minute
infusion
of
910
mg/m
2
the
peak
plasma
concentration
of
amifostine
is
approximately 200
µ
mol/L, the Vd
ss
(steady state) is 7 L and the clearance is 2 L/min. Peak plasma
concentration of the active metabolite, WR-1065, during the 15-minute
infusion is approximately
35
µ
mol/L. Measurement of WR-1065 in bone marrow cells 5-8 minutes after
the infusion in three
patients was 82, 121 and