Each 50 ml or 100 ml amber vial of infusion concentrate contains. Find the full product monograph that is prepared for healthcare professionals and. The earliest marketed date recorded in the drug product database. Cisplatin side effects, dosage, interactions drugs.
Cisplatin hydration guidelines for outpatients introduction there is increasing demand to treat more patients as outpatients. Identification of the substancemixture and of the companyundertaking product name. Oct 05, 2014 cisplatin is stable under normal temperatures and pressures, but may transform slowly over time to the transisomer iarc 1981, akron 2009. Find documents on drug safety and administration for healthcare providers, including calculations. Delayed onset hearing loss has been reported in pediatric patients. Product monograph pravastin bevacizumab for injection 100 mg and 400 mg vials 25 mgml solution for injection antineoplastic hoffmannla roche limited 7070 mississauga road mississauga, ontario l5n 5m8. Cisplatin dosing, indications, interactions, adverse. May use concomitant amifostine to decrease nephrotoxicity. Cisplatin hydration for outpatients chemotherapy regimen. So far no recurrence, but the chemo brain has become a terrible handicap. Cellular mechanisms of activity, drug resistance and induced side effects. Manufacturers or drug sponsors are required to develop a detailed product monograph in accordance with the guidance document.
Cisplatin injection description clinical pharmacology fda. Higher doses of cisplatin are being given in daycare, increasing the strain on the chemotherapy suites and pharmacy. When selecting the application type in an epla, the compendial application type must be selected when attesting to a product monograph. Pharmacokinetics of cisplatin and combination chemotherapy of. Cisplatin is similar to the bifunctional alkylating agents. Alimta product monograph page 3 of 61 alimta pemetrexed disodium for injection 100 mg or 500 mg pemetrexed per vial part i. In order to for patients to be treated as a day case, the regimens have been modified as follows. It is clear, colourless or slightly yellow solution free from particulates and is. This difference makes carboplatin more stable and has less. Cisplatin can cause severe bone marrow suppression with fatalities due to infection. Numerous mechanisms of cisplatin resistance were described including changes in cellular uptake, drug efflux, increased detoxification, inhibition of apoptosis and increased dna repair. Pharmacokinetics of cisplatin and combination chemotherapy. Prtaxotere docetaxel for injection concentrated solution.
Several payment sources exist for cancer drugs in ontario, depending on the drug, disease indication, and how and where it is delivered. Cisplatin is stable under normal temperatures and pressures, but may transform slowly over time to the transisomer iarc 1981, akron 2009. Trastuzum ab can result in sub clinical and clinical cardiac. To minimize cisplatin resistance, combinatorial therapies were developed and have proven more effective to defeat cancers. Ototoxicity may be more pronounced in younger children. Jun 01, 2015 cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin.
It is given by injection into a vein common side effects include bone marrow suppression, hearing. Cisplatin cisplatin dose, indications, adverse effects. Like cisplatin, it contains a platinum atom surrounded in a plane by two. However, the platinum from cisplatin becomes bound to plasma proteins. Health professional information summary product information route of administration dosage form strength clinically relevant nonmedicinal ingredients intravenous lyophilized powder 100 mg or 500 mg. Platinolaq cisplatin injection prescribing information. Product monograph prgemcitabine injection page 5 of 54 general in all instances where the use of gemcitabine injection is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse events. Cisplatin is one of the most potent chemotherapy drugs widely used for cancer treatment. In a phase i trial in which paclitaxel was administered as a 24hour infusion and cisplatin was administered as a 1 mgmin infusion, myelosuppression was more profound when paclitaxel was given after cisplatin than with the alternate sequence i. Dose level 2 gemcitabine mgm 2, cisplatin 25 mgm 2, s1 80 mgm 2 per day was designated as rd.
Trastuzumab monograph december 2014 updated version may be found at. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula ptcl. Risk of venous thromboembolism in patients with cancer treated with cisplatin. Each vial of platinol contains 50 mg cisplatin, 450 mg sodium chloride, usp, and 500 mg mannitol, usp.
Dbl carboplatin injection, solution for injection medsafe. The monographs below are currently referenced by the nhp ingredients database but do not yet have a generated monograph, which means that less information is prepopulated in the epla. The ratios of cisplatin to total free ultrafilterable platinum in the. Toposar etoposide injection, usp also commonly known as vp16 is a semisynthetic derivative of. Cisplatin is a chemotherapy medication used to treat a number of cancers. Cisplatin has a number of side effects that can limit its use. The other two ligands in carboplatin are present in a ring structure rather than as two chloride atoms in cisplatin. Cisplatin for injection is a sterile, lyophilized mixture of cisplatin, mannitol, and sodium chloride. Each 50 ml, 100 ml or 200 ml amber vial of cisplatin injection contains. The highest aug of total and free pt and lowest cmax of free pt were observed in daily continuous infusion.
The risk of ototoxicity may be increased by concomitant administration of other ototoxic drugs e. Pci can be used to speed up the evaluation of the nhp, and serves as a reliable source of product information for consumers. This phase 1 doseescalation study was designed to define the mtd and rd of combination chemotherapy with gemcitabine, cisplatin, and s1 in patients with advanced biliary tract cancer. Toposartm 817 607 000 etoposide injection, usp warnings toposar etoposide injection, usp should be administered under the supervision of a qualified physician experienced in the use of cancer. Phase i trial of combination chemotherapy with gemcitabine. Any use of the information is subject, at all times, to ccos terms and conditions. Cisplatin is particularly effective against testicular cancer. Cisplatin is a medicine used alone or with other therapies to treat cancer of the testicles, ovaries, or bladder the drug is also sometimes used offlabel to treat head and neck. When deciding on the wording, there is careful consideration given to the content, language and format used.
Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. These complexes are slowly eliminated with a halflife of 5 days or more. Cddp,1 cisdiamminedichloroplatinum 2dichlorodiammineplatinumii. Product monograph pr paclitaxel injection usp paclitaxel injection, 6 mgml. By completing a consumer side effect reporting form and sending it by. Cisplatin injection cisplatin injection cisplatin cisplatin injection injection is a sterile aqueous solution, available in 50, 100 and 200 ml multiple dose vials, each ml containing 1 mg of cisplatin cisplatin injection and 9 mg sodium chloride in water for injection. The ratios of cisplatin to total, free ultrafilterable platinum in the plasma range from 0. Prcisplatin injection bp page 3 of 26 cisplatin does not undergo instantaneous and reversible binding to plasma proteins characteristic of normal drugprotein binding. Dec 31, 2019 cisplatin injection is a clear, colorless, sterile aqueous solution. Apply separately 5l quantities of each solution to a thinlayer chromatographic plate coated with a 0.
Procedure prepare a test solution containing 1 mg of cisplatin per ml and a standard solution containing 1 mg of usp cisplatin rs per ml, both in dimethylformamide. Hci andor sodium hydroxide added to adjust ph to 3. Monitor complete blood counts before initiating therapy, prior to each new cycle, and as clinically indicated. Paclitaxel injection accord healthcare inc page 6 of 39. Spontaneous reports of ars cannot be used to estimate the incidence of ars because ars remain underreported and patient exposure is unknown. Cisplatin dosing, indications, interactions, adverse effects. Consumer information pralimta pemetrexed disodium for injection this leaflet is part iii of a threepart product monograph published when alimta was approved for sale in canada and is designed specifically for consumers. Cisplatin injection is a clear, colorless, sterile aqueous solution. Cisplatin injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials. Cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. Dilute preservativefree solution with 2 l of 5% dextrose and 0.
Ultrafilterable platinum consists of carboplatin and free carboplatin metabolites. Adjunct to other antineoplastic agents for the treatment of metastatic testicular tumors including nonseminomatous testicular carcinoma, seminoma testis, and extragonadal germcell tumors in patients who have already received appropriate surgery andor radiation therapy. Prior to use of cisplatin may also result in a decrease of etoposide total body clearance in children. Like cisplatin, it contains a platinum atom surrounded in a plane by two ammonia groups and two other ligands in the cis position. These include testicular cancer, ovarian cancer, cervical cancer, breast cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma.
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting eli lilly canada inc. Cisplatin fda prescribing information, side effects and uses. Accumulation of free ultrafilterable platinum in plasma can potentially occur when cisplatin is. Many people living with cancer experience nausea, diarrhea and other symptoms from their treatment or disease. Cisplatin, the active ingredient in cisplatin for injection, usp, is a yellow to orange crystalline powder with the molecular formulacl 2 h 6 n 2 pt and a molecular weight of 300. Tested schedules of cisplatin were single short term infusion80 mgm 2,2h div. Pembrolizumab monograph 1 pembrolizumab keytruda national drug monograph february 2016. Dec 12, 2018 product monograph prpaclitaxel for injection page 6 of 43 rare reports of more severe events such as phlebitis, cellulitis, induration, skin exfoliation, necrosis and fibrosis have been received as part of the continuing surveillance of paclitaxel. Cisplatin is used to treat various types of cancer. Postage paid labels and the consumer side effect reporting form are available at. The discovery and development of cisplatin article pdf available in journal of chemical education 835 may 2006 with 4,548 reads how we measure reads. This leaflet is a summary and will not tell you everything about alimta.
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