Deferasirox Dispersible Tablet
Product name: Deferasirox Dispersible Tablet
Main ingredients and chemical name: every piece contain: Deferasirox Dispersible Tablet 125mg
Character The product is a white or light yellow tablet.
Indications
It is used to treat chronic iron overload caused by frequent blood transfusions (monthly dose of packed red blood cells > 7 mlkg) in patients with B-thalassemia older than 2 years; For iron overload caused by other transfusion-dependent diseases, the safety and efficacy data of this product in Chinese patients are limited, and it is recommended to use it according to the doctor's advice.
It is also used for the treatment of chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassemia syndrome.
Pharmacology and toxicology
pharmachologic effect
Deferasirox is an orally active chelating agent that is highly selective for iron (Fe). It is a ligand with three coordination groups that binds to iron in a ratio of 2:1 with high affinity. Although the affinity of deferasirox to zinc and copper is very low, the concentration of these trace metals in the serum still decreases to varying degrees after administration. The clinical significance of these reductions in metal concentrations is unclear. Toxicological studies
Genotoxicity
The Ames test of deferasirox and the chromosomal aberration test of human peripheral blood lymphocytes were negative, and the results of 1 of the 3 rats administered orally in vivo micronucleus test were positive.
Shijiazhuang No.4 Pharmaceutical Co., Ltd. was established in 1948, now it is a large-sized foreign invested enterprise and comprehensive medicine manufacturer in China, the capital is USD58 million, and with more than 3000 employees. The company can manufacture 7 series medicines of more than 100 kinds and specifications including infusions, capsules, granules, tablets, oral liquids and etc with GMP approval by SFDA of China. For the key product of large volume I.V solution, the yearly output has reached more than 1200 million bottles including 40 million bottles packing with the soft plastic bottles in the dosage of 500 ml/ 250 ml /100ml. Some index such as quality, variety, and yearly output are all in the leading position of this field in China.
The products have been sold to some countries and regions in South America, Africa, and Asia.
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