PHENASEN arsenic trioxide 10 mg/10 mL injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

arsenic trioxide, Quantity: 1 mg/mL

זמין מ:

Phebra Pty Ltd

INN (שם בינלאומי):

arsenic trioxide

טופס פרצבטיות:

Injection, concentrated

הרכב:

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

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

10 x 10 mL vials

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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.

leaflet_short:

Visual Identification: Clear and colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

2009-05-13

עלון מידע

Phenasen
®
1 of 3
_Version 11_
_ _
PHENASEN
®
CONTAINS 10 MG IN 10 ML ARSENIC TRIOXIDE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Phenasen. 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 Phenasen 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 IN A SAFE PLACE.
You may need to read it again.
WHAT PHENASEN IS USED
FOR
Phenasen 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
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 YOU ARE GIVEN
PHENASEN
_WHEN YOU MUST NOT BE GIVEN _
_IT_
_ _
YOU SHOULD NOT BE GIVEN PHENASEN 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 Phenasen.
Your doctor will discuss this with you.
DO NOT BREAST-FEED IF YOU ARE BEING
GIVEN THIS MEDICINE.
The active ingredient in Phenasen
passes into breast milk and there is a

מאפייני מוצר

PRODUCT INFORMATION
Australian Product Information – Phenasen Injection
Version 18
Page 1 of 14
PHENASEN
®
CONCENTRATED SOLUTION FOR INFUSION
(ARSENIC TRIOXIDE)
1
NAME OF THE MEDICINE
Arsenic trioxide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Phenasen contains 10 mg arsenic trioxide as the active
ingredient in a 10 mL glass vial.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Phenasen is a clear, colourless, concentrated solution for infusion.
It is a sterile solution for single use. The pH of
Phenasen is between 5.0 - 8.5. Phenasen 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
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.
Phenasen may be given in combination with all-_trans _retinoic acid
(ATRA) and/or chemotherapy.
IN PATIENTS WITH NEWLY DIAGNOSED/_DE NOVO _APL COMBINATION TREATMENT
Phenasen may be given in combination with all-_trans_-retino