See actual entry in rtecs for complete information. 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. Updated layout 01052019 english clp safety data sheet. We prepare safety data sheets for nearly every european country, so do contact us if you need one. Standard operating procedure for paclitaxel taxol in animals 1. Paclitaxel injection, usp safety data sheet sds effective date. Sigmaaldrich offers a number of paclitaxel products. The overall biotransformation rate between paclitaxel and cephalomannine differed slightly 184 vs. Preparation and dissolution profiles of the amorphous. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Standard operating procedure for paclitaxel taxol in animals.
All work practices must be designed to reduce human exposure to the lowest level. The compound, originally isolated from taxus yunnanensis, has shown potential growth inhibitory activities against human cancer cells. Paclitaxel is obtained via a semisynthetic process from taxus baccata. Prtaxotere docetaxel for injection concentrated solution. Paclitaxel c cas 153415453 scbt santa cruz biotechnology. Representative images of colony formation in c643 cells treated with vehicle control dmso or lenvatinib and paclitaxel at the indicated concentrations, individually or in combination, are shown in left panel. Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer. Product information sheet pdf specification sheet pdf. You may contact the medical information center by visiting or by calling 1800janssen 18005267736 1800janssen 18005267736 to speak to a clinical expert regarding your question or to report a possible adverse event or product quality complaint. Abaid ln1, goldstein bh, micha jp, rettenmaier ma, brown jv 3rd, markman m.
Women must use birth control while taking paclitaxel conventional. Synergistic inhibition of colony formation of atc cells by lenvatinib and paclitaxel. Free safety data sheet index public health agency of canada phac provides the following safety data sheets related to the hazardous properties of human pathogens or infectious diseases. Paclitaxel with polyoxyethylated castor oil injection. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Extinguishing media suitable extinguishing media water spray jet, dry powder, foam, carbon dioxide, adapt extinguishing media to surrounding fire conditions flash point liquid not applicable unsuitable extinguishing media. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Improved overall survival with 12 cycles of singleagent. Paclitaxel is the active ingredient in the drug product sold under the trade names abraxane and taxol. When paclitaxel with polyoxyethylated castor oil is used to treat breast cancer, ovarian cancer, or nonsmall cell. Paclitaxel is contraindicated during lactation see section 4.
Safety against nephrotoxicity in paclitaxel treatment. Paclitaxel paclitaxel dose, indications, adverse effects. This solution can be diluted with saline to give a final concentration of 0. The compound, originally isolated from taxus yunnanensis, has shown potential growth inhibitory activities against human cancer cells references. Taxotere, in combination with doxorubicin as first line therapy, should be reserved for patients with potentially life threatening disease such as visceral or lung metastatic disease. Paclitaxel should not be used in patients with baseline neutrophils paclitaxel is also contraindicated in patients with concurrent, serious, uncontrolled infections. Significant antitumor activity has been demonstrated in clinical trials against a wide variety of tumors, including ovarian carcinoma, breast cancer, head and neck cancers and nonsmall cell lung cancer rowinsky and donehower, 1995. Paclitaxel is a white to offwhite crystalline powder with the empirical formula c47h51no14 and a molecular weight of 853. Paclitaxel is associated with doserelated bone marrow suppression.
A population pharmacokinetic model was developed using the nonlinear mixed effect modelling program nonmem. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Find out what health conditions may be a health risk when taken with paclitaxel intravenous. In case of contact with eyes, immediately flush eyes with water for at least 5 minutes. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid. Material and methods materials paclitaxel gift sample from dabur pvt. Paclitaxel isolated from natural sources or produced by fermentation. This sds will be revisited as more data become available. Abraxane for injectable suspension paclitaxel proteinbound.
Weve included the most sought after safety data sheets, and the database just keeps growing. Improved overall survival with 12 cycles of singleagent paclitaxel maintenance therapy following a complete response to induction chemotherapy in advanced ovarian carcinoma. Paclitaxel plasmaconcentration time profiles were available from 55 patients m. Abraxane is a cytotoxic drug and, as with other potentially toxic paclitaxel compounds, caution should be exercised in handling abraxane. The use of this drug during pregnancy has resulted in birth defects. Paclitaxel investigated as a drug, mutagen, reproductive effector, and tumorigen. This product information was approved at the time this auspar was published. For patients with advanced hiv infection, paclitaxel therapy should only be initiated or continued if the neutrophil count is above 1,000 cellsmm3. Sds of paclitaxel side chain acid, safety data sheets, cas. In mouse plasma incubated at 37 degrees c for 72 h, the most paclitaxel was released using cmdexpaclitaxel conjugate with 2gly followed by, in descending order, 2ala, 2leu, 2ile, and 7gly.
Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Health hazards paclitaxel is a natural product with antitumor activity. Hazards identification classification of the substance or mixture. Promotion of microtubule assembly in vitro by taxol. Please get in touch with any questions you may have. Buy paclitaxel c cas 153415453, a paclitaxel related compound c, from santa cruz. Paclitaxel is also soluble in ethanol and acetonitrile. It should not be given to patients with severe thrombocytopenia or neutropenia, with solid tumors who have baseline neutrophil counts of less than 1,500 cellsmm3, with aidsrelated kaposis sarcoma, or with baseline neutrophil count is less than cellsmm3. Paclitaxel is known as one of the most effective anticancer drugs in the market today. Paclitaxel is a naturally occurring antineoplastic agent and stabilizes tubulin polymerization. Enhanced solubility and stability of pegylated liposomal. Paclitaxel is a potent antineoplastic and antimitotic taxane drug, which binds to the n. As in any fire, wear selfcontained breathing apparatus pressuredemand niosh approved or.
Sds of paclitaxel, safety data sheets, cas 33069624. Webmd provides common contraindications for paclitaxel intravenous. Product information for auspar abraxane paclitaxel nab abraxis pm20152314 date of finalisation 17 june 2014. Oct 28, 2016 paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution. A population pharmacokinetic model was developed using the nonlinear mixed effect modelling. Formulation and evaluation of paclitaxel loaded psapeg. Contraindications for paclitaxel intravenous webmd. If abraxane lyophilized cake or reconstituted suspension contacts the skin, wash. The ic 50 of paclitaxelinduced mitotic block is 4 nm 4. Paclitaxel ptxl is an anticancer drug, which is widely used for treating patients with solid tumors such as refractory ovarian cancer, metastatic breast cancer, nonsmall cell lung carcinomas, head and neck malignancies and aidsrelated kaposis sarcoma etc.
Only select registry of toxic effects of chemical substances rtecs data is presented here. Apr 27, 2020 paclitaxel is contraindicated during lactation see section 4. Search the australian register of therapeutic goods. Includes dosages for breast cancer, nonsmall cell lung cancer, breast cancer adjuvant and more. Pronounced in vivo antitumor efficacy of oral paclitaxel nanoemulsion in solid tumor bearing model the 28day toxicity study of the nanoemulsion proved to be a viable media to deliver paclitaxel. Paclitaxel taxol is a potent antineoplastic and antimitotic taxane compound used in cancer chemotherapy. In case of contact, immediately wash skin with soap and water for at least 5 minutes. Injection for intravenous iv infusion in 5ml vials with equivalent of paclitaxel 30 mg, 16. Formerly known as material safety data sheets, phac now refers to them as pathogen safety data sheets or psdss. Paclitaxel injection, usp is available in 30 mg 5 ml, 100 mg 16.
Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage 1. Paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution. One of the biggest shortcomings of this drug, however, is. Paclitaxel is a white to offwhite crystalline powder with the empirical formula. This drug is currently approved in at least one country for use in patients with advanced carcinoma of the ovary andor breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant. Disclaimer the sds samples above are collected from the internet by chemblink and displayed here for the tutorial purpose only. Pharmaceutical product antineoplastic details of the supplier of the safety data sheet 2. Population pharmacokinetics of orally administered. Paclitaxel is a white to off white crystalline powder that is highly lipophilic and insoluble in water. Bevacizumab with paclitaxel to treat metastatic breast. Our msds database is an easy to use, do it yourself tool, and best of all. Formulation development and evaluation of paclitaxel. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database.
Paclitaxel should not be used in patients with baseline neutrophils 10 x uln or bilirubin 5 x uln. If abraxane lyophilized cake or reconstituted suspension contacts the skin, wash the skin immediately and thoroughly with soap and water. Material safety data sheet msds for paclitaxel cell signaling. Calculate the percentage content of c47h51no14 from the declared content of paclitaxel crs. Abraxane powder for injection suspension abraxis bioscience australia pty ltd. Paclitaxel 6 mgml concentrate for solution for infusion. In mouse plasma incubated at 37 degrees c for 72 h, the most paclitaxel was released using cmdex paclitaxel conjugate with 2gly followed by, in descending order, 2ala, 2leu, 2ile, and 7gly. Population pharmacokinetics of orally administered paclitaxel. Paclitaxel can cause both mitotic arrest and apoptotic cell death. Taxane relevant identified uses of the substance or mixture and uses advised against intended use.
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