Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
Thalidomide
Celgene Australia Pty Ltd
Medicine Registered
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 Baca dokumen lengkap
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 Baca dokumen lengkap