DOMIDE CAPSULE 50MG

Страна: Малайзия

Език: английски

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

Активна съставка:

THALIDOMIDE

Предлага се от:

PHARM-D SDN. BHD.

INN (Международно Name):

THALIDOMIDE

Броя в опаковка:

60Capsule Capsules

Произведено от:

TTY BIOPHARM CO LTD

Листовка

DOMIDE CAPSULE 50MG
Thalidomide (50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Please make sure you have signed the "Consent for Treatment" and
understand the explanation given by your doctor or pharmacist
before taking this medicine
.
WHAT IS IN THIS LEAFLET
1.
What _Domide _is used for
2.
How _Domide_ works
3.
Before you use _Domide_
4.
How to use _Domide_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Domide_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _DOMIDE _IS USED FOR
Domide is used in combination with
melphalan and prednisolone for the
treatment of multiple myeloma patients
who are aged 65 years or more, or who
cannot be given high dose chemotherapy.
It
is
used
with
dexamethasone
for
patients with newly diagnosed multiple
myeloma, to be given before high dose
chemotherapy with autologous stem cell
rescue.
Domide
is
used
to
treat
patients
who
have moderate to severe skin lesions of
leprosy (Erythema Nodosum Leprosum),
but it is not used as the lone treatment for
skin lesions when patients have moderate
to severe nerve pain.
Domide is used for preventing and
keeping the skin lesions of leprosy from
recurring._ _
HOW _DOMIDE_ WORKS
Domide works by blocking the
development of cancer cells, inhibiting
blood vessels growing in the cancer, and
modulating human immune function.
BEFORE YOU USE _DOMIDE_
-
_When you must not use it _
_ _
-
You are a woman and are pregnant
or want to become pregnant or are
likely to become pregnant. If you
must take this medicine, please
prevent pregnancy.
-
You are a man and have unprotected
sex with women who may become
pregnant. Domide can be found in
the semen of patients taking the
medication, and this may cause risk
to the baby.
-
You are allergic to Domide or other
components of the drug.
_ _
-
_Before you start use it _
Please make sure you have signed the
"Consent for Treatment" and
understand the explanation given by
your doctor or pharmacist before taking
this medicine, especially abou

Данни за продукта

- 1 -
DOMIDE Capsule s 50 mg (Thalidomide)
【 WARNING 】
SEVERE, LIFE -THREATENING HUMAN BIRTH DEFFECTS.
If thalidomide is taken during pregnancy, it can cause severe birth
defects or death to an unborn baby. Thalidomide should never be used
in women who are pregnant or who could become pregnant while
taking the drug. Even a single dose taken by a pregnant woman during
her pregnancy can cause severe birth defects. Before starting
treatment, patien ts have to read and sign the informed consent form
for female/male patients for taking DOMIDE and must comply with the
instructions and follow physicians’ directions. Once treatment has
started, if you are unable or unwilling to comply with the instruction s
or directions, you have to stop taking DOMIDE and inform your doctors.
【 DESCRIPTION 】
Each DOMIDE capsule contains 50mg of active ingredient,
thalidomide. The appearance of capsules is hard capsules, and white
body orange cap.
Thalidomide, α -(N-phthalimido) glutarimide, is an immunomodulatory
agent. The empirical formula is C13H10N2O4, and the gram
molecular weight is 258.2. The CAS number of thalidomide is 50 -35-
1.
Note: * = asymmetric carbon
Thalidomide is an off -white to white, odorless, crystalline powder that
is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water
and ethanol. The glutarimide moiety contains a single asymmetric
center and, therefore, may exist in either of t wo optically active forms
designated S -(-) or R -(+). DOMIDE (thalidomide) is an equal mixture
of the S -(-) and R -(+) forms and, therefore, has a net optical rotation
of zero.
Thalidomide is available in 50 mg capsules for oral administration.
【 Excipients 】
Avicel ph -l02; Lactose Monohydrate; Lactose spray -dried; Corn
starch; Silicon dioxide; Stearic acid; Magnesium stearate.
【 CLINICAL PHARMACOLOGY 】
Mechanism of Action
The mechanism of action of thalidomide is not fully understood.
Thalidomide possesses immunomodulatory, anti -inflammatory and
antiangiogenic properties. Available data from in v