VESANOID tretinoin 10mg capsules bottle

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

tretinoin, Quantity: 10 mg

متاح من:

Pharmaco Australia Ltd

الشكل الصيدلاني:

Capsule, soft

تركيب:

Excipient Ingredients: purified water; glycerol; yellow beeswax; iron oxide yellow; Gelatin; titanium dioxide; iron oxide red; Soya Oil; partially hydrogenated soya oil; hydrogenated soya oil; maize starch; sorbitol; mannitol

طريقة التعاطي:

Oral

الوحدات في الحزمة:

100 capsules

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

VESANOID should be used for induction of remission in acute promyelocytic leukemia (APL; FAB classification AML-M3). Previously untreated patients as well as patients who relapse after or are refractory to standard chemotherapy (daunorubicin and cytosine arabinoside (ARA-C)or equivalent therapies) may be treated with VESANOID. Following complete remission, consolidation full dose chemotherapy should be employed. A loss of responsiveness to VESANOID has been reported among patients maintained on VESANOID. The median time to relapse for patients maintained on VESANOID is 4 to 6 months.

ملخص المنتج:

Visual Identification: Soft gelatin oval capsule, one half orange-yellow opaque, other half reddish-brown opaque.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

1995-11-01

نشرة المعلومات

VESANOID – Consumer Medicine Information 2019-07 v1.0
1
VESANOID
_contains the active ingredient tretinoin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VESANOID
capsules.
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 taking VESANOID
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VESANOID IS
USED FOR
VESANOID contains the active
ingredient called tretinoin or retinoic
acid.
VESANOID belongs to a group of
medicines called chemotherapeutic
agents which works by stopping or
slowing the growth of cancer-causing
cells.
It is specially developed to target
cancer cells rather than normal,
healthy cells.
VESANOID belongs to a class of
drugs known as retinoids, which are
very similar to Vitamin A.
VESANOID is given to people who
have acute promyelocytic leukaemia
(APL). This is a disease which
affects the way the myelocytes grow.
Myelocytes are large cells in your
bone marrow from which leucocytes
(white blood cells) develop.
VESANOID is thought to work by
stopping the growth of APL cells.
VESANOID may be used whether or
not you have had chemotherapy
before.
Your doctor may have prescribed
VESANOID for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY VESANOID
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
VESANOID
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VESANOID IF:
•
YOU ARE PREGNANT, OR WITHIN ONE
MONTH BEFORE YOU INTEND TO
BECOME PREGNANT.
If you fall
pregnant while taking
VESANOID there is an
extremely high risk of having a
baby that is severely deformed.
You must use effective
contraception for one month
before, during and one month
after treatment.
•
YOU ARE BR

خصائص المنتج

2022-04 v4.0
1
AUSTRALIAN PRODUCT INFORMATION – VESANOID
(TRETINOIN) CAPSULES
1
NAME OF THE MEDICINE
Tretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VESANOID is available as oval, soft gelatin capsules containing 10 mg
of tretinoin; one half
of each capsule is opaque orange-yellow and the other half opaque
reddish brown.
Excipients of known effect: partially hydrogenated soya oil,
hydrogenated soya oil and soya
oil.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Soft gelatin capsules.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
VESANOID should be used for induction of remission in acute
promyelocytic leukaemia
(APL; FAB classification AML-M3). Previously untreated patients as
well as patients who
relapse after or are refractory to standard chemotherapy (daunorubicin
and cytosine
arabinoside (ARA-C) or equivalent therapies) may be treated with
VESANOID. Following
complete remission, consolidation full-dose chemotherapy should be
employed. A loss of
responsiveness to VESANOID has been reported among patients maintained
on VESANOID.
The median time to relapse for patients maintained on VESANOID is 4 to
6 months.
4.2
D
OSE AND METHOD OF ADMINISTRATION
A total daily dose of 45 mg/m
2
body surface area, divided in two equal doses, is
recommended for oral administration to APL patients. This is
approximately 8 capsules per
patient per day. Data on the correct dose for paediatric, geriatric,
renally and hepatically
impaired patients are limited. A dose of 45 mg/m
2
may be given, and a dose reduction should
be considered if severe toxicity occurs. Dose reduction should be
particularly considered for
children with intractable headache. Treatment should be continued for
30 to 120 days except
when the disease progresses; 84% of responding patients achieve CR by
90 days. After
complete remission, a standard course of consolidation chemotherapy
should be initiated
immediately; for example, three 7-day courses of daunorubicin and
cytosine arabinoside, in 5
to 6 week int