During all fire fighting activities, wear appropriate protective equipment, including self contained breathing apparatus. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Identification of the substancemixture and of the company. Taxol paclitaxel injection for dilution is supplied as a nonaqueous clear, colourless to slightly yellow viscous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel investigated as a drug, mutagen, reproductive effector, and tumorigen. Our msds database is an easy to use, do it yourself tool, and best of all. Cell signaling technology 3 trask lane danvers, ma 0 923 usa ix. If you have had an allergic reaction to paclitaxel you may be given paclitaxel combined with a protein. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. The recommended dose of paclitaxel is 80 2mgm administered by intravenous infusion over approximately 60 minutes on days 1, 8 and 15 of a 28 day cycle. However, we make no warranty of merchantibility or any other warranty, express or implied. Preparation instructions paclitaxel is soluble in dmso 50 mgml. Abraxane is a cytotoxic drug and, as with other potentially toxic paclitaxel compounds, caution should be exercised in handling abraxane.
This product information was approved at the time this auspar was published. Please consult the material safety data sheet for information regarding hazards and safehandling practices. Direct contact with eyes may cause temporary irritation. This includes ovarian cancer, breast cancer, lung cancer, kaposi sarcoma, cervical cancer, and pancreatic cancer.
All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions. We aimed to investigate the efficacy and safety of nab paclitaxel versus solventbased paclitaxel in patients with previously treated advanced gastric cancer. The information herein is based on data considered to be accurate as of the date of preparation of this material safety data sheet. It is highly lipophilic, insoluble in water, and melts at around 216217 c. Abraxane powder for injection suspension abraxis bioscience australia pty ltd. Paclitaxel 6 mgml concentrate for solution for infusion.
Pronounced in vivo antitumor efficacy of oral paclitaxel nanoemulsion in solid tumor bearing model. Skin contact may cause burning sensation, stinging, itching and tingling. Women of childbearing potential receiving paclitaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur. However, no warranty or representation, expressed or implied, is made as to the accuracy or completeness of the foregoing data and safety information. Albuminbound paclitaxel is a sterile, white to yellow lyophilized powder that must be reconstituted for. Material safety datasheet 9sections section 1 product information product identifier drytype transformer whmis classification optional product use electrical manufacturers name hammond power solutions inc. Box 697, osprey, florida, 342290697 941 3779935 fax 941 3779539 cas number 67630. Standard operating procedure for paclitaxel taxol in animals 1.
Paclitaxel is commercially available as proteinbound particles consisting of paclitaxel bound to albumin. Jan 24, 2019 5 mgm2 iv over 24 hours followed by cisplatin every 3 weeks. Women must use birth control while taking paclitaxel conventional. Taxol paclitaxel dosing, indications, interactions, adverse. Paclitaxel taxol is a naturally occurring antineoplastic agent and stabilizes tubulin polymerization. If inhaled if breathed in, move person into fresh air. List of drug master files dmf of paclitaxel active pharmaceutical ingredient api submitted to the u. Paclitaxel paclitaxel dose, indications, adverse effects. If you wish to search by description, please use the site search feature.
In an in vitro angiogenesis assay, paclitaxel at ultra low concentrations blocks human ecs from forming sprouts and tubes in the threedimensional fibrin matrix. Paclitaxel when it is given in combination with a platinum compound, e. Although noninferiority of nab paclitaxel every 3 weeks to weekly solventbased paclitaxel for overall survival was not confirmed, progressionfree survival and objective responses were similar in both groups of patients. Paclitaxel represented a mean of 5% of the administered radioactivity recovered in the feces, while metabolites, primarily 6. The microtubule dysfunction induced by paclitaxel results in aberrant cell mitosis and. Download msdsmaterial safety data sheet of paclitaxel. You can search by item code, sds code or manufacturer code. Online account customers can also search by invoice number, order.
None of the components is considered a reproductive hazard. Nab paclitaxel every 3 weeks was associated with more frequent toxicities than weekly solventbased paclitaxel. Paclitaxel ptx, sold under the brand name taxol among others, is a chemotherapy medication used to treat a number of types of cancer. Paclitaxel injection, usp safety data sheet sds effective date. Paclitaxel name of proposed course of treatment include brief explanation if medical term not clear paclitaxel chemotherapy for the treatment of breast cancer. The cell cycle arrest effect of pac medchem express hyb0015. 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. Understanding and correcting msds file upload errors during the file upload process in msds, users will often receive a popup message indicating the file was uploaded successfully, yet sometimes the data never reaches the staging area. Mechanistically, paclitaxel arrests cell cycle and induces cell death by stabilizing microtubules and interfering with microtubule disassembly in cell division. Paclitaxel is a novel antimicrotubule agent that promotes the assembly of microtubules.
May cause irritation, redness, inflammation or dryness. Since paclitaxel injection is a flammable solution, remove all sources of ignition. Material safety data sheet prepared according to 29 cfr 1910. Paclitaxel hazard statements h315 causes skin irritation. Sds lookup this page helps you find, save and then print sds sheets. Contact of undiluted concentrate with plasticized pvc equipment or devices is not recommended. If abraxane lyophilized cake or reconstituted suspension contacts the skin, wash the skin immediately and thoroughly with soap and water. Product information for auspar abraxane paclitaxel nab abraxis pm20152314 date of finalisation 17 june 2014. Understanding and correcting msds file upload errors. Page 1 7 material safety data sheet issuing date 10apr2011 revision date 1jan20 revision number 1 1. Dispose of contentscontainer to an approved waste disposal plant. Pharmaceutical product antineoplastic details of the supplier of the safety data sheet 2. This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates.
Health hazards paclitaxel is a natural product with antitumor activity. Product and company identification product name sortkwik recommended use apply to fingers to improve grip for filing and sorting. The recommended dose of ramucirumab is 8 mgkg on days 1 and 15 of a 28 day cycle, prior to paclitaxel infusion. H334 may cause allergy or asthma symptoms or breathing difficulties if inhaled. This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all.
Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Paclitaxel injection, usp is available in 30 mg 5 ml, 100 mg 16. Search the australian register of therapeutic goods. Although this interaction has not been studied, predictions about the interaction can be made based on the metabolic pathway of paclitaxel. Cells including human neonatal dermal microvascular ecs hmvecs, human umbilical vein ecs huvecs, human. Paclitaxel page 2 of 3 developed by danafarber cancer institute last revised 052018 patient and family education committee 5. Precautionary statements p201 obtain special instructions before use. Paclitaxel, diluted in culture medium, is added in quadruplicate wells and the cells ae incubated for 3 days before mts reagents are added to quantitate the live cells in each well. When paclitaxel with polyoxyethylated castor oil is used to treat breast cancer, ovarian cancer, or nonsmall cell lung cancer it is usually given once every 3 weeks. Additionally, higher doses of nab paclitaxel can be administered over a shorter infusion time and at higher drug concentrations compared with solventbased paclitaxel. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Feb 20, 2014 paclitaxel taxol, one of the most important anticancer drugs, has been used for therapy of different types of cancers. Abraxane is supplied as a white to yellow, sterile, lyophilised cake for reconstitution in a 50 ml clear type i glass vial with a latex free, bromo butyl rubber stopper, individually packaged in a carton.
Paclitaxel api dmfs us drug master file dmf details. Paclitaxel 6 mgml concentrate for solution for infusion should not be used during pregnancy unless the clinical condition of the woman requires treatment with paclitaxel. Data supplied is for use only in connection with occupational safety and health. Nabpaclitaxel versus solventbased paclitaxel in patients. See actual entry in rtecs for complete information.
Page 1 of 5 patient agreement to systemic anticancer therapy. Only select registry of toxic effects of chemical substances rtecs data is presented here. Paclitaxel c47h51no14 c47h51no14 853,91 gmol concentration casno. Paclitaxel is a substrate of the drug efflux transporter pglycoprotein pgp and of the hepatic isoenzyme cyp3a4. Analytical data hnmr consistent with structure hplc shows 99. Albuminbound paclitaxel is a sterile, white to yellow lyophilized powder that must be reconstituted for use as an injectable suspension. Flammable liquid and vapor keep away from ignition sources and clean up spills promptly.
Paclitaxel with polyoxyethylated castor oil injection. Taxane relevant identified uses of the substance or mixture and uses advised against intended use. Standard operating procedure for paclitaxel taxol in animals. Paclitaxel is a white to offwhite crystalline powder with the empirical formula. Abraxane for injectable suspension paclitaxel proteinbound. Paclitaxel for injection contains ethanol absolute alcohol, 396 mgml. Weve included the most sought after safety data sheets. Paclitaxel is obtained via a semisynthetic process from taxus baccata. Administer corticosteroids, h1antagonists, h2 antagonists, prior to paclitaxel administration to minimize potential for anaphylaxis. H361 suspected of damaging fertility or the unborn child.
H361 suspected of damaging fertility or the unborn. Absorb solution with activated charcoal or absorbent pads. Jan 02, 2020 if you are 65 or older, use paclitaxel conventional with care. Nov 06, 2014 your new online msds binder is a place for you to store the material safety data sheets you need to deploy. The submission of this msds may be required by law, but this is not an assertion that the substance is hazardous when used in accordance with proper safety practices and normal handling procedures. Consult the manufacturer product information or local protocol for premedication guidelines.
If data for a hazard are not included in this document there is no known information at this time. Administer through iv tubing containing an inline 0. Material safety data sheet paclitaxel injection sost. Paclitaxel taxol is a potent antineoplastic and antimitotic taxane compound used in cancer chemotherapy. Taxol paclitaxel injection rx only patient information included warning taxol paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Sds of paclitaxel side chain acid, safety data sheets, cas. Highlights of prescribing information these highlights do not include all the information needed to use taxotere safely and effectively. Paclitaxel with polyoxyethylated castor oil injection comes as a liquid to be injected over 3 or 24 hours intravenously by a doctor or nurse in a hospital or clinic. Paclitaxel is the generic nonbranded name of the drug, but you may hear it called by one of its brand names such as taxol. In vitro, paclitaxel induces caspase 8mediated apoptosis through the association of caspase 8s death effector domain with microtubules. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. For the firstline treatment of nonsmall cell lung cancer in. Oct 28, 2016 paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution.
View indentification, hazards, safety information, toxicity, regulations. In the presence of smf, the efficient concentration of paclitaxel on k562 cells is decreased from 50 to 10 ngml. Each single use vial contains 100 mg of paclitaxel and 900 mg. Dermal 2,000 mgkg based on an assessment of the ingredients. Formation of toxic gases is possible during heating or fire. Pfizer inc believes that the information contained in this material safety data sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. Paclitaxel is a potent antineoplastic and antimitotic taxane drug, which binds to the n. This product is not classified as toxic by established criteria. The 28day toxicity study of the nanoemulsion proved to be a viable media to deliver paclitaxel. Send us your paper safety data sheets and well professionally scan and convert them to pdf format before indexing them. Show this safety data sheet to the doctor in attendance. Paclitaxel can cause both mitotic arrest and apoptotic cell death. Paclitaxel also dysregulates the epithelialtomesenchymal emt transition, inducing transition of cancer cells into benign fibroblastlike cells.
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