VESANOID

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TRETINOIN

متاح من:

TZAMAL BIO-PHARMA LTD

ATC رمز:

L01XX14

الشكل الصيدلاني:

CAPSULES

تركيب:

TRETINOIN 10 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CHEPLAPHARM ARZNEIMITTEL GMBH, GERMANY

المجال العلاجي:

TRETINOIN

الخصائص العلاجية:

Induction of remission in acute promyelocytic leukemia.

تاريخ الترخيص:

2021-05-31

نشرة المعلومات

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) – 1986
This medicine is dispensed with a doctor's prescription only
Vesanoid
®
Capsules
Active ingredient and its quantity:
Each capsule contains:
tretinoin 10 mg
Inactive ingredients and allergens: See section 6 ‘Additional
information’ and section 2
‘Important information about some of this medicine’s
ingredients’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
Special warnings for women
•
Before starting to use Vesanoid, tell your doctor if you are pregnant,
think you are
pregnant or are planning to become pregnant.
•
You should not become pregnant during and within one month after
stopping treatment
with Vesanoid. If you do become pregnant while taking Vesanoid, it is
very likely that
your baby will be born seriously deformed.
•
Women of childbearing age should use effective birth control
throughout treatment and
for one month after treatment is stopped. Your doctor will advise you
on what methods
of contraception are the most appropriate for you.
•
If you are taking oral contraceptives with a low dose of progestogen
(also called “mini-
pill”), your doctor will tell you to stop using this contraceptive
and will prescribe a
different contraceptive for the time you are being treated with
Vesanoid.
•
During the treatment period, women should take a pregnancy test every
month.
•
Tell your doctor immediately if you become pregnant while taking this
medicine.
•
Do not breastfeed during treatment with Vesanoid. Vesanoid enters the
breast milk and
could therefore harm your baby.
1.
What is this medicine intended for?
Vesanoid is intended for the treatment of patients with acute
promyelocyt

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vesanoid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Active substance:
1 capsule contains 10 mg of tretinoin
(
all-_trans_ retinoic acid, ATRA
)
Excipients with known effect:
1 capsule contains 107.92 mg of soya-bean oil.
The capsule-shell contains between 1.93 – 2.94 mg of sorbitol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule
Bi-coloured, orange-yellow / reddish-brown capsules.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Vesanoid is indicated for induction of remission in acute
promyelocytic leukaemia
(APL).
4.2
Posology and method of administration
Posology
A total daily dose of 45 mg/m
2
body surface divided in two equal doses is
recommended for oral administration to APL patients. This is
approximately 8
capsules per adult dose.
Paediatric population
There is limited safety and efficacy information on the use of
tretinoin in children.
It is recommended that pediatric patients be treated with 45 mg/m
2
unless severe
toxicity becomes apparent. Dose reduction should be particularly
considered for
children with intractable headache.
Patients with hepatic and/or renal impairment
Due to the lack of extensive information in case of renal and/or
hepatic insufficiency,
the dose will be decreased to 25 mg/m
2
as a precautionary measure.
Method of administration
Treatment should be continued until complete remission has been
achieved or up to a
maximum of 90 days.
After completion of remission, a consolidation chemotherapy including
anthracycline
and cytosine arabinoside should be initiated immediately; for example,
three courses
in 5 to 6 week intervals.
If there has been a remission with tretinoin alone, it is not
necessary to modify doses
of tretinoin if tretinoin is used with chemotherapy.
Capsules should be swallowed whole together with water. Capsules
should not be
chewed. It is recommended that tretinoin be administered with a meal
or shortly
thereafter.
4.3
Contraindications
Hypersensitivity to t