If inhaled if breathed in, move person into fresh air. The admixture should be a clear and colorless to slightly yellow solution. Although its exact mechanism of action is unknown this agent appears to act. Bendamustine hydrochloride sc207320 hazard alert code key. Niosh list of antitneoplastic and other hazardous drugs in. Powder for concentrate for solution for infusion bendamustine hydrochloride the name of your medicine is bendamustine hydrochloride 2. Osha, cma, ansi, canadian whmis standards, european union clp ec 12722008 and the global harmonization standard. Osha, cma, ansi, canadian whmis and european community standards part i what is the material and what do i need to know in an emergency. Bendamustine was used at a 20 um concentration for in vitro culture with skmel28 and cell viability was monitored over time with live imaging. The clinical trials on this list are studying bendamustine hydrochloride.
Venetoclax is the generic name for the trade name drug venclexta. A phase i study of bendamustine hydrochloride administered. In chronic lymphocytic and mantle cell lymphoma cell lines, bendamustine hcl has been shown to activate both the mitochondrial cell death pathway and caspasedependent apoptosis. Amendment in ec for change in product mix with change in category for pfr manufacturing unit of active pharma ingredients api and intermediates. Niosh list of antineoplastic and other hazardous drugs in. Dailymed treanda bendamustine hydrochloride injection. Ncis basic information about clinical trials explains the types and phases of trials and how they are carried out. Other companies are charging thousands of dollars to set up. Handling should only be performed by personnel trained and familiar with handling of potent active pharmaceutical ingredients. Read all of this leaflet carefully before you start.
Show this safety data sheet to the doctor in attendance. Please note that preregistration is required to buy reference standards. Nonsterile compounding overview 2016 update handout. Bendamustine hydrochloride rat oral ld 50 200 300 mgkg 4 days mouse intraperitoneal 12. Co2, hydrogen chloride, phosgene, nitrogen oxides nox, other pyrolysis products typical of burning organic material. Active pharmaceutical ingredients apis alendronate sodium drotverine hydrochloride methyl paraben amlodipine besylate dexrabeprazole milnacipran alogliptin benzoate donepezil hcl montelukast sodium acebrophylline duloxetine hcl mirabegron. This msds, and the associated product, is intended for use only by technically qualified persons, and at. Bendamustine hcl dacarbazine everolimus leuprolide acetate palifermin streptozocin vigabatrin bexarotene dactinomycin exemestane lomustine paroxetine sunitinib malate vinblastine sulfate bicalutamide dasatinib finasteride mechlorethamine pazopanib hcl tacrolimus vincristine sulfate. It is used by mouth or by injection into a vein common side effects include nausea and bone marrow suppression. Socmi hap volatile hap organic hap ozone depleting arsenic trioxide the information presented above is offered for informational purposes only. Iv drug compatibility chart a alteplase activase, rtpa amiodarone cordarone argatroban atropine calcium chloride diltiazem cardizem dobutamine dobutrex dopamine epinephrine adrenalin esmolol brevibloc furosemide lasix heparin insulin regular lidocaine xylocaine lorazepam ativan magnesium sulfate. Bendamustine hydrochloride api manufacturers suppliers. Tocris bioscience is the leading supplier of novel and exclusive tools for life science research with over 30 years experience in the industry.
Individual must not have received bendamustine in a previous line of therapy. If you have questions on roche medicines, please contact the medical information team. Bendamustine hcl treanda is considered medically appropriate if all of the following criteria are met. Although the exact mechanism of action of bendamustine is unknown, this agent appears to alkylate and crosslink macromolecules, resulting in dna, rna and protein synthesis inhibition, and eventually the induction of apoptosis. Treanda bendamustine hydrochloride 05feb2010 1 of highlights of prescribing information these highlights do not include all the information needed to use treanda safely and effectively. Bendeka is indicated for the treatment of patients with chronic lymphocytic leukemia cll or indolent bcell nonhodgkin lymphoma nhl that has progressed during or within six months of treatment with rituximab or a rituximabcontaining regimen. Buy bendamustine hydrochloride cas 3543757, a nitrogen mustard purine analog. Bendamustine hydrochloride is also being studied in the treatment of other types of cancer. Clinical trials are research studies that involve people. It works by blocking nerve impulses or pain sensations that are sent to your brain. Treanda is contraindicated in patients with a known hypersensitivity e.
Bcell nonhodgkin lymphoma nhl that is indolent slowgrowing and got worse during or within 6 months after treatment with rituximab. Rituxan can cause this condition to come back or get worse. They should seek advice about sperm conservation prior to treatment with bendamustine hydrochloride because of possible irreversible infertility. What is the material and what do i need to know in an emergency. Dec 29, 2017 treanda bendamustine hcl injection is intended for intravenous infusion only after dilution with either 0. Bendamustine hydrochloride is the hydrochloride salt of bendamustine, a bifunctional mechlorethamine derivative with alkylator and antimetabolite activities. Material safety data sheet of bendamustine hydrochloride.
Your new online msds binder is a place for you to store the material safety data sheets you need. Features and benefits this compound is a featured product for apoptosis research. Following iv administration, peak plasma concentration attained at the end of the infusion. Sds of bendamustine hydrochloride, safety data sheets, cas. Bendamustine is an anticancer chemotherapy drug and is classified as an alkylating agent. Niosh list of antineoplastic and other hazardous drugs in healthcare settings 2014. View all us drug master files dmf, dmfs filed by olon spa with the fda on. Safety data sheet according to federal register vol. Apr 10, 20 bendamustine hydrochloride cas 3543757 msds 1. Pdf the purpose of this study was to characterise bendamustines cytotoxic and apoptotic activity in a. Bendamustine hydrochloride is the generic ingredient in three branded drugs marketed by cephalon and eagle pharms, and is included in three ndas.
Buy bendamustine hydrochloride cas 3543757, a nitrogen mustard purine analog alkylator, from santa cruz. Bendamustine hydrochloride national cancer institute. Bendamustine fact sheet international waldenstroms. After transferring, thoroughly mix the contents of the infusion bag. May cause eye, skin, or respiratory system irritation.
Other severe side effects may include anaphylaxis and the development of other cancers. Bendamustine is a bifunctional mechlorethamine derivative with alkylating and antimetabolite activities. Bendamustine hydrochloride fexofenadine hydrochloride rispridone. Directly or indirectly, all parties to healthcare benefits influence policy and demand satisfaction of their interests. Bcg infections have been reported in health care workers, primarily from exposures. Bendeka bendamustine hydrochloride injection, solution dailymed.
If medical attention is not available on the worksite or surroundings send the patient to a hospital together with a copy of the msds. Material safety data sheet of bendamustine hydrochloride contains identification of substance and details of the supplier of the safety data sheet. Treanda msds page 1 of 10 material safety data sheet prepared to u. P201 obtain special instructions before use p202 do not handle until all safety precautions have been read and understood. Bendamustine hydrochloride 3543757 buy and find out price and availability, msds, properties of tcis high quality specialty chemicals. Bendamustine hydrochloride drug entry bendamustine. C16h21cl2n3o2hclxh2o 394,72 gmol concentration bendamustine hydrochloride casno. Pdf cytotoxic efficacy of bendamustine in human leukemia and. Bendamustine is a nitrogen mustard drug indicated for use in the treatment of chronic lymphocytic leukemia cll and indolent bcell nonhodgkin lymphoma nhl that has progressed during or within six months of treatment with rituximab or a rituximabcontaining regimen. The mixture was filtered to remove the activated charcoal. Bendamustine hydrochloride cas 3543757 msds guidechem. If youre not able to select an item from this list, it means the item is restricted and cannot be ordered online as we first need to ensure that dea requirements are fulfilled.
This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of. Search for safety data sheets either by product namesynonym, the empirical formula or the chemical abstracts number. C16h21cl2n3o2 hcl xh2o 394,72 gmol concentration bendamustine hydrochloride casno. Bendeka bendamustine hcl injection information for patients. Apr 09, 2020 what are the generic drug sources for bendamustine hydrochloride and what is the scope of patent protection. Bendamustine hydrochloride pharmacokinetics absorption bioavailability. Nov 21, 2019 treanda bendamustine hcl injection for intravenous use is supplied as a sterile clear colorless to yellow solution in a singledose vialeach 0. Bendamustine impurity 23 hcl bendamustine nalkylated impurity hcl cas no. Inquire about dmf, cgmp, price, availability, samples, sourcing, purity and more. Clinical trials using bendamustine hydrochloride national. Identification of the substancemixture and of the companyundertaking product identifiers product name. Bendamustine, sold under the brand name treanda among others, is a chemotherapy medication used in the treatment of chronic lymphocytic leukemia cll, multiple myeloma, and nonhodgkins lymphoma. In myeloma cell lines, bendamustine induced apoptosis by cleavage of caspase 3, and resulted in g2 cell cycle arrest 2.
Pending revisions which have been approved for potential adoption are published on the compendial notices section of the uspnf website under notices of intent to revise. Material may be irritating to the mucous membranes and upper respiratory tract. Treanda for injection singleuse vial containing 100 mg of bendamustine hcl as white to offwhite lyophilized powder. Methocarbamol is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury. Treanda for injection singleuse vial containing either 25 mg or 100 mg of bendamustine hcl as white to offwhite lyophilized powder. Some side effects may occur during the infusion or within 24 hours afterward. Male patients should not father a child during and up to 6 months after treatment. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Treanda bendamustine hydrochloride for injection, for intravenous infusion. Melphalan, sold under the trade name alkeran among others, is a chemotherapy medication used to treat multiple myeloma, ovarian cancer, melanoma, and amyloidosis. Bendamustine hydrochloride santa cruz biotechnology. Pending monographs are published for comment in the inprocess revision section of the pharmacopeial forum.
In vitro sister chromatid exchange not specified positive bendamustine hydrochloride version. Check the msds or the proper handling section of the. Call your doctor if you have painful skin or mouth sores, or a severe skin rash with blistering, peeling, or pus. Bendamustine fact sheet last update 11282015 bendamusteen generic name. Bendamustine hydrochloride cas 3543757 scbt santa cruz.
Learn more about bendeka bendamustine hcl injection. Bendamustine hydrochloride monograph for professionals. May 29, 2007 the aim of the study was to determine the maximum tolerated dose mtd, the dose limiting toxicity dlt, and the pharmacokinetic profile p k of bendamustine bm on a day 1 and 2 every 3 weeks schedule and to recommend a safe phase ii dose for further testing. Bendamustine hcl treanda for the treatment of other conditionsdiseases is considered investigational. Apexbio bendamustine hclcytostatic agent for nonhodgkin. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. We prepare, maintain, and provide the sdss pursuant to applicable laws based on available information. Severe skin problems can also occur during treatment with rituxan. Precautions should be taken to avoid extravasation, including monitoring of the intravenous infusion site for redness, swelling, pain, infection, and.
Terms of access to pfizer s safety data sheets for its products pfizer develops safety data sheets sdss for our products to help our employer customers occupational health and safety specialists assure workplace safety and comply with applicable laws. This medication is injected slowly into a vein by a health care professional as directed by your doctor the dosage is based on your medical condition, body size. Further action will be the responsibility of the medical specialist. The reconstituted solution must be transferred to the infusion bag within 30 minutes of reconstitution.
Treanda product monograph page 5 of 40 there are postmarketing reports of bendamustine extravasations resulting in hospitalizations from erythema, marked swelling and pain. Bendeka is indicated for the treatment of patients with chronic lymphocytic leukemia cll or indolent bcell nonhodgkin lymphoma nhl that has progressed during or within six months of treatment with rituximab or a. For specific information about product hazards, refer to safety data sheets sds via the vehs website at. In some cases, health care professionals may use the trade name venclexta when referring to the generic drug venetoclax. Bendamustine hydrochloride is a dnaalkylator with a distinct pattern of activity. Bendamustine activates dnadamage stress response and apoptosis. Bendamustine hydrochloride is teratogenic and mutagenic. Bcl2 inhibitor for more detail, see how this drug works below. It is supplied as a sterile clear colorless to yellow solution in a singledose vial at the concentration of 90 mgml of bendamustine hcl. Department of health and human services, centers for disease control and prevention, national institute for occupa.
Treanda c16h21cl2n3o2 hcl xh2o 394,72 gmol concentration bendamustine hydrochloride casno. There are twentyfour patents protecting this compound and three paragraph iv challenges. The % sign acts as wildcard in cas number and empirical formula search. Formula c16h21cl2n3o2 hcl sc207320 bendamustine hydrochloride revision date 16.
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