VESANOID SOFT-GELATIN CAPSULE 10MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TRETINOIN/RETINOIC ACID

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

TRETINOIN/RETINOIC ACID

Unit dalam pakej:

100 Capsules; 100 Capsules

Dikeluarkan oleh:

Catalent Germany Eberbach GmbH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
VESANOID® SOFT-GELATIN CAPSULE
_ _
Tretinoin (10mg)
1
What is in this leaflet
1.
What
_Vesanoid_
_® _
is used for
2.
How
_Vesanoid_
_® _
works
3.
Before you use
_Vesanoid_
_®_
4.
How to use
_Vesanoid_
_®_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Vesanoid_
_®_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _VESANOID_
_® _
IS USED FOR
_Vesanoid_
_® _
is
intended
to
treat
acute
promyelocytic leukemia (APL), a type of
blood cancer.
In combination with chemotherapy, all-
_trans_
retinoic acid increases the duration
of survival, reduces the risk of relapse
compared to chemotherapy alone.
HOW _VESANOID_
_® _
WORKS
_Vesanoid_
_®_
contains the active ingredient
tretinoin, which is also called all-
_trans_
retinoic acid.
_Vesanoid_
_®_
is a retinoid which works to
stop
or
slow
the
growth
of
cancer-
causing cells. It targets cancer cells rather
than normal, healthy cells.
BEFORE YOU USE _VESANOID_
_® _
Tell your doctor before taking
_Vesanoid_
_®_
if you ever had any kind of mental health
problems.
This
includes
depression,
aggressive tendencies or mood changes.
_Mental health problems _
Your mood may be affected while taking
_Vesanoid_
_®_
. You may not notice some
changes in your mood and behaviour and
so it is very important that you tell your
friends and family that you are taking this
medicine. They may notice these changes
and
help
you
quickly
identify
any
problems that you need to talk to your
doctor about.
-
_When you must not use it_
Do
not
take
_Vesanoid_
_® _
if
you
have
hypersensitivity to all-
_trans_
retinoic acid
or any of its components.
_Pregnancy and lactation _
Do
not
take
_Vesanoid_
_® _
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant unless the benefit of
all-
_trans_
retinoic
acid
treatment
outweighs the risk of foetal abnormalities
due to the severity of the condition and
the urgency of treatment.
Do not take
_Vesanoid_
_® _
if y

Ciri produk

VESANOID
®
Tretinoin
CATEGORY
CYTOSTATIC-DIFFERENTIATING AGENT
1. PRODUCT DESCRIPTION
_Active ingredient_: all-_trans_ retinoic acid (ATRA, tretinoin).
_Galenical form:_ capsules 10 mg.
_Excipients:_ Capsule contents: yellow beeswax, hydrogenated soybean
oil, partially hydrogenated
soybean oil, soybean oil. _Capsule shell_: gelatin, glycerol, karion
(sorbitol, mannitol, starch (maize)),
titanium dioxide, iron oxide yellow, iron oxide red.
2. PROPERTIES AND EFFECTS
All-_trans_ retinoic acid is a natural metabolite of retinol and
belongs to the class of retinoids, comprising
natural and synthetic analogues. _In vitro_ studies with all-_trans_
retinoic acid have demonstrated induction
of differentiation and inhibition of cell proliferation in transformed
haemopoietic cell lines, including
human myeloid leukaemia cell lines.
The mechanism of action in acute promyelocytic leukaemia (APL) is not
known, may be due to an
alteration in binding of all-_trans_ retinoic acid to a nuclear
retinoic acid receptor (RAR) given that the α-
receptor of retinoic acid is altered by fusion with a protein called
PML.
3. PHARMACOKINETICS
All-_trans_ retinoic acid is an endogenous metabolite of vitamin A and
is normally present in plasma. Oral
doses of all-_trans_ retinoic acid are well absorbed and maximum
plasma concentrations in healthy
volunteers are attained after 3 hours. There is a large inter-patient
and intra-patient variation in
absorption of all-_trans_ retinoic acid. In plasma, all-_trans_
retinoic acid is extensively bound to plasma
proteins. Following peak levels, plasma concentrations decline with a
mean elimination half-life of 0.7
hours. Plasma concentrations return to endogenous levels following a
single 40 mg dose after 7 to 12
hours. No accumulation is seen after multiple doses and all-_trans_
retinoic acid is not retained in body
tissues.
During continuous administration, a marked decrease in plasma
concentration can occur, possibly due to
cytochrome P450 enzyme induction which increases clearance and
decreases bio