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THALIDOMIDE PHARMION
®
(THALIDOMIDE 50MG) HARD CAPSULES
CONSUMER MEDICINE INFORMATION
SEVERE LIFE-THREATENING BIRTH DEFECTS:
THALIDOMIDE HAS CAUSED SEVERE BIRTH DEFECTS WHEN TAKEN DURING
PREGNANCY.
THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR
WHO COULD
BECOME PREGNANT WHILST TAKING THE DRUG OR COULD BECOME PREGNANT
WITHIN 4
WEEKS AFTER STOPPING THE DRUG. EVEN A SINGLE DOSE CAN CAUSE SEVERE
BIRTH
DEFECTS.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Thalidomide
Pharmion.
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 Thalidomide
Pharmion against the benefits this medicine is expected to 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.
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
WHAT THALIDOMIDE PHARMION IS USED FOR
Thalidomide Pharmion contains an active substance called thalidomide.
This belongs to a group of
medicines known as immuno-modulating agents that work by acting on
the cells involved in the
body’s immune system._ _The immune system is part of the
body’s defence which helps to fight illness
and infection.
Treatment of Multiple Myeloma
Thalidomide Pharmion is used to treat multiple myeloma, a cancer of
the bone marrow.
It is used_ _in combination with other medicines, melphalan and
prednisone, for the treatment of newly
diagnosed multiple myeloma in patients aged over 65 years or patients
who cannot receive high dose
chemo
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Thalidomide Pharmion (thalidomide) 50 mg capsules - Product Information
Celgene v2.2 – November 2011
1
PRODUCT INFORMATION
THALIDOMIDE PHARMION 50MG HARD CAPSULES
TERATOGENIC EFFECTS:
THALIDOMIDE HAS CAUSED SEVERE BIRTH DEFECTS WHEN TAKEN DURING
PREGNANCY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE
PREGNANT OR WHO COULD BECOME PREGNANT WHILST TAKING THE DRUG OR COULD
BECOME PREGNANT WITHIN 4 WEEKS AFTER STOPPING THE DRUG. EVEN A SINGLE
DOSE CAN CAUSE BIRTH DEFECTS._ _
NAME OF THE DRUG MEDICINE:
Thalidomide Pharmion 50mg Hard Capsules.
DESCRIPTION:
Each capsule contains 50mg of thalidomide. Thalidomide is 2-(2,6-dioxo-3-
piperidinyl)-1H-iso-indole-1,3(2H)-dione. The structural formula is:
CAS No: 50-35-1
Molecular formula: C
13
H
10
N
2
O
4
Relative molecular mass: 258.23
Thalidomide is a white to off-white powder. Thalidomide is practically insoluble in
water, more soluble in ethanol and acetonitrile and very soluble in DMF and DMSO.
It has a partition coefficient in octanol/water at room temperature of about 5.
Thalidomide contains one single asymmetric carbon atom, alpha to the phthalimido
nitrogen. The molecule can, therefore, exist in either of two complementary optically
active forms. Thalidomide used in the Thalidomide Pharmion 50mg Hard Capsules
formulation is a racemic mixture containing an equal amount of the S(-) and R(+)
forms and therefore has a net optical rotation of zero.
Thalidomide Pharmion (thalidomide) 50 mg capsules - Product Information
Celgene v2.2 – November 2011
2
PHARMACOLOGY:
The mechanism of action of thalidomide
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