Arsenic Trioxide Accord arsenic trioxide 10 mg/10 mL injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

arsenic trioxide, Quantity: 10 mg

Sẵn có từ:

Accord Healthcare Pty Ltd

Dạng dược phẩm:

Injection, concentrated

Thành phần:

Excipient Ingredients: hydrochloric acid; water for injections; sodium hydroxide

Tuyến hành chính:

Intravenous

Các đơn vị trong gói:

5, 10, 1

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

For the induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.,For the induction of remission and consolidation in patients with previously untreated acute promyelocytic leukaemia (APL) in combination with all-trans retinoic acid (ATRA) and/or chemotherapy and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.

Tóm tắt sản phẩm:

Visual Identification: A clear colourless solution, practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2020-10-20

Tờ rơi thông tin

Version 1.0
Page 1 of 3
ARSENIC TRIOXIDE ACCORD
_Arsenic Trioxide Concentrated Injection 10 mg/10 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Arsenic Trioxide Accord.
It does not contain all the available
information. It does not take the place of
talking to your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of you
being given Arsenic Trioxide Accord
against the benefits they expect it will
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 ARSENIC TRIOXIDE
ACCORD IS USED FOR
Arsenic Trioxide Accord is used to treat
acute promyelocytic leukaemia also
known as APL.
This medicine works by interfering with
the growth of cancer cells and slowing
their growth and spread in the body.
Your doctor may have prescribed it for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ARSENIC TRIOXIDE
ACCORD HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a
doctor's prescription.
There is not enough information to
recommend the use of this medicine for
children under the age of 5 years.
BEFORE RECEIVING
ARSENIC TRIOXIDE ACCORD
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN ARSENIC
TRIOXIDE ACCORD IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing arsenic or
arsenic trioxide
•
any of the ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin.
YOU SHOULD NOT BE GIVEN THIS MEDICINE
IF YOU ARE PREGNANT.
It may affect your developing baby if you
are given it during pregnancy.
Men and women of childbearing age
must use effective birth control while
they are being treated with Arsenic
Trioxide Accord. Your doctor will
discuss this with you.
DO NOT BREAST-FEED IF YOU ARE B

Đặc tính sản phẩm

Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
ARSENIC TRIOXIDE ACCORD (ARSENIC TRIOXIDE) CONCENTRATED
INJECTION
1
NAME OF THE MEDICINE
Arsenic trioxide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 1 mg arsenic trioxide.
1 vial of 10 mL concentrated injection contains 10 mg arsenic
trioxide.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Arsenic Trioxide Accord is a clear, colourless, concentrated injection
for infusion Arsenic Trioxide
Accord must be diluted before use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the induction of remission and consolidation in patients with
acute promyelocytic leukaemia (APL)
who are refractory to, or have relapsed from, retinoid and
anthracycline chemotherapy, and whose APL
is characterised by the presence of the t(15:17) translocation or
PML/RAR-alpha gene expression.
For
the
induction
of
remission
and
consolidation
in
patients
with
previously
untreated
acute
promyelocytic
leukaemia
(APL)
in
combination
with
_all-trans _
retinoic
acid
(ATRA)
and/or
chemotherapy and whose APL is characterised by the presence of the
t(15:17) translocation or
PML/RAR-alpha gene expression.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Arsenic Trioxide Accord must be diluted before use.
METHOD OF ADMINISTRATION
0.15 mg/kg/day diluted with 100 - 250 ml of 5% glucose injection or
0.9% sodium chloride injection
and administered intravenously (IV) over two hours.
Cycles of treatment are given to achieve complete remission, defined
as the complete disappearance of
all leukaemic myeloblasts and promyelocytes and < 5% overall
myeloblasts by morphological
examination of the marrow. After induction of remission, consolidation
cycles may be given, and
maintenance therapy considered. Arsenic Trioxide Accord may be given
in combination with all-trans
retinoic acid (ATRA) and/or chemotherapy.
IN PATIENTS WITH NEWLY DIAGNOSED/_ DE NOVO_ APL COMBINATION TREATMENT
Arsenic Trioxide Accord may be given in combination with
all-trans-retinoic acid (ATRA) and/