Thalidomide Pharmion

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

Thalidomide

थमां उपलब्ध:

Celgene Australia Pty Ltd

वर्ग:

Medicine Registered

सूचना पत्रक

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

उत्पाद विशेषताएं

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

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PHARMACOLOGY: 

The  mechanism  of  action  of  thalidomide�