Deferasirox icl 670 is an orally available iron chelator used for the management of transfusional iron overload. Avoid the use of high pressure water, which could generate dust. Get batchspecific data and documents by batch number. Section 1 identification of the substancemixture and of the companyundertaking. Calculate doses mgkg per day to the nearest whole tablet.
Sds of deferasirox, safety data sheets, cas 201530418. Vinyltrichlorosilane safety data sheet 06162015 en english us sds id. This product is not classified as toxic by established criteria. Deferasirox is designated chemically as 43,5bis2hydroxyphenyl1 h 1,2,4triazol1ylbenzoic acid and has the following structural formula. Applicants are strongly encouraged to use the ndpsc electronic. Deferasirox impurity 1 tlc pharmaceutical standards. M of deferasirox for 24 or 48 h, and proliferation is determined by an mtt assay2. Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. Oct 20 section i product and company identification weldon p70 low voc primer for pvc and cpvc plastic pipe low voc primer for pvc and cpvc plastic pipe manufacturer.
Consider repaglinide dose reduction and monitor blood glucose levels. Only select registry of toxic effects of chemical substances rtecs data is presented here. Deferasirox inhibited the growth of all four gastric cancer cell lines in a dosedependent and timedependent manner fig. Export data and price of deferasirox under hs code 2933 zauba. Monitor plasma concentrations of busulfan when coadministered with deferasirox to allow. Product is a pale, oillike liquid with a vegetable oil citrus odor. Deferasirox exjade, 43,5bis 2hydroxyphenyl1h1,2,4triazol1ylbenzoic acid fda approved iron chelating agent calcein fluoresceinmethyleneiminodiacetic acid possibly harmful via ingestion, skin contact, or inhalation. Accidental release measures contain spill and collect, as appropriate. Partb simultaneous reverse phase high performance liquid. Exjade deferasirox tablets for oral suspension 4, 5.
Ips corporation 17109 south main street, gardena, ca 902483127 p. The information provided in this safety data sheet is correct to the best of our knowledge, information and belief at the date of its publication. Deferasirox has been linked to a low rate of transient serum aminotransferase elevations during therapy and to rare instances of clinically apparent liver injury, which can be severe and even fatal. The primary objective of the study was to compare the efficacy of the 2 dose regimens of deferasirox starting doses of 5 and 10 mgkgday with that of placebo in patients with ntdt, based on change in lic from baseline after one year of treatment. Relevant identified uses of the substance or mixture and uses advised against for research use only. List of drug master files dmf of active pharmaceutical ingredients apis submissions by biocon limited to the u. It is a tridentate ligand that binds iron with high affinity in a 2. Deferasirox is soluble in organic solvents such as ethanol, dmso, and dimethyl. The information provided in this material safety data sheet is correct to the best of our knowledge, information and belief at the date of its publication. Biocon limited dmfs us drug master file dmf details. Use water spray to cool containers and structures exposed to fire. View detailed export data, price, monthly trends, major exporting countries, major ports of deferasirox under hs code 2933.
Handling and storage precautions for safe handling. May be harmful by inhalation, ingestion, or skin absorption. In case of contact, immediately flush skin with plenty of water. Section 1 identification of the substancemixture and of the companyundertaking 1. Chemicalbook provide chemical industry users with deferasirox boiling point melting point,deferasirox density msds formula use,if you also need to deferasirox other information,welcome to contact us. Deferasirox loaded on fumed silica nanoparticles used in. Do not take antacids that have aluminum in them with this medicine deferasirox tablets. If you are 55 or older, use this medicine deferasirox tablets with care. The recommended initial daily dose of exjade is 20 mgkg body weight. None of the components is considered a reproductive hazard. Product name deferasirox product code sc207509 cas no 201530418 pure substancemixture substance 1.
Australian public assessment report for deferasirox. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Deferasirox is an oral iron chelating agent used to treat chronic iron overload. May cause eye, skin, or respiratory system irritation. Its main use is to reduce chronic iron overload in patients.
Feb 20, 2020 have a hearing test before starting this medicine deferasirox tablets and while you take this medicine deferasirox tablets. See actual entry in rtecs for complete information. Methods for cleaning up keep combustibles wood, paper, oil, etc. Also, long sleeve cotton shirt and long pants if handling molten polymer. Deferasirox iron complex scbt santa cruz biotechnology. Format of the application amendment to follow the section heading. Reference is also made to the tentative approval letter issued by this office on february 18, 2015, and to your amendment dated november 11, 2015.
Engineering controls should be used as the primary means to control exposures. Since the ic 50 of deferasirox at 72 h was the lowest in ags cells less than 10. Despite this products obvious natural make up, an attempt has been made on this msds to illustrate how even natural materials, used incorrectly, can have negative health effect. Hazard identification classification according to regulation no 12722008ec company. Material safety data sheet university of louisville. Export data and price of deferasirox under hs code 2933. Deferasirox is an orally bioavailable synthetic, tridentate iron chelator that binds iron at a 2. Safety data sheet according to federal register vol.
Deferasirox has a survival benefit for sio leukemia murine model in terms of iron chelation and antileukemic therapy3. Dermal 2,000 mgkg based on an assessment of the ingredients. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. This document has been prepared in accordance with standards for workplace safety, which requires the inclusion of all known hazards of the product or its ingredients regardless of the. Msds material data safety sheet 8 gram compressed gas n2o filled charger 1. Pdf deferasiroxan oral agent for chronic iron overload. More sds files for chemicals 201485383 2015090 20151400 2015147 2015205 201531762 201531773 201531886 201532016 201532425. Accidental release measures personal precautions, protective equipment and emergency procedures any person in the area of the spill should be fully equipped with protective equipment chemical resistant clothing, footwear, gloves, safety glasses and respirator. Alligare, llc 800 4249300 chemtrec, transportation and spills opelika, al 36801 product name. Protective gloves are required when handling hot polymer. Chemtrec 8004249300 msds material data safety sheet. Take exjade once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day.
National drugs and poisons schedule committee record of. Exjade increases the exposure of the cyp2c8 substrate repaglinide. Jul 25, 2019 jadenu deferasirox is an ironchelating agent provided as a tablet or granules for oral use. In case of fire, use water spray fog, foam, dry chemical or co2. Safety data sheet neena jordan page 3 of 7 july 10, 2017 special protective equipment and precautions for firefighters firefighters should wear selfcontained breathing apparatus and full protective clothing. Safety glasses are recommended to prevent particulate matter from entering eyes while grinding or machining. Safety data sheet page 4 of 8 august 31, 2017 section 6.
The potential of deferasirox as a novel therapeutic modality. Msds material data safety sheet 8 gram compressed gas n2o. Exposure control personal protection osha hazardous components 29 cfr 1910. In case of contact, immediately flush eyes with plenty of water. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the. Do not take exjade with aluminumcontaining antacid products.
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