Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Hemlibra emicizumabkxwh injection, for subcutaneous use. Ncisplatin at a dose of 100 mgm2 should be administered intravenously after the infusion of gemcitabine for injection on day 1. For directions regarding the use and administration of cyclophosphamide please refer to its package insert.
Survival figure 1 for patients receiving navelbine plus cisplatin was significantly better compared to the patients who received singleagent. Vistide is a sterile, hypertonic aqueous solution for intravenous infusion only. There is only one package insert per dispenser box. Information for the user cisplatin 1mgml concentrate for solution for infusion cisplatin the name of your medicine is cisplatin 1 mgml concentrate for solution for infusion but in the rest of the leaflet it. As a single agent, cisplatin injection should be administered at a dose of 100 mgm 2 iv per cycle once every four weeks. In combination therapy, cisplatin injection and cyclophosphamide are administered sequentially. Aug 01, 20 novartis animal health us, inc for use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency. Highlights of prescribing information these highlights do not include all the information needed to use portrazzasafely and effectively. Adenoscan should be used with caution in patients with obstructive lung disease not associated with bronchoconstriction e. Additional copies of the package insert can be found at. Highlights of prescribing information these highlights do not include all the information needed to use. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Cisplatin fda prescribing information, side effects and uses. Review the prescribing information for nivolumab for full dosing and schedule information.
Mar 01, 2019 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. Tepezza teprotumumabtrbw for injection, for intravenous use. Package insert of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section. Nerlynx as a single agent is indicated for the extended adjuvant treatment of adult patients with earlystage. Highlights of prescribing information sinoatrial sa and. Do not substitute herceptin trastuzumab for or with adotrastuzumab emtansine. Verify dose using body surface area prior to dispensing. Sections or subsections omitted from the full prescribing information are not listed. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored grade 34 serum creatinine toxicity for gemzar plus cisplatin was 5% versus 2% for cisplatin alone. Preexisting cisplatin induced neurotoxicity does not worsen in about 70% of the patients receiving carboplatin as secondary treatment. Xtandi enzalutamide capsules, for oral use initial u. Mar 23, 2020 mononine is not indicated in the treatment or prophylaxis of hemophilia a patients with inhibitors to factor viii. Insert pdf file content into a powerpoint presentation powerpoint.
See 17 for patient counseling information and medication. In the choose a file to insert dialog box, click the pdf file you want to print to onenote, and then click insert. Paraplatin carboplatin for injection, usp is supplied as a sterile, lyophilized white powder available in singledose vials containing 50 mg, 150 mg, and 450 mg of carboplatin for administration by intravenous infusion. Highlights of prescribing information neulasta safely and. Cisplatin 1 mgml sterile concentrate summary of product. Cisplatin injection is a clear, colorless, sterile aqueous solution. Do not use in dogs suffering from congestive heart disease, severe renal disease or. 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. May 01, 2016 leucovorin calcium tablets usp, 25 mg are available as pale green, round, unscored, biconvex tablets, debossed with b on one side and 485 on the other side, packaged in bottles of 25 ndc 0555048527 and 500 ndc 0555048504 tablets. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over. Refer to an fdaapproved tests package insert for instructions on the identification of patients eligible for treatment with xalkori. Cidofovir is a white crystalline powder with an aqueous solubility of.
For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available. Insert pdf printouts into notes in onenote for mac onenote for mac. Follow applicable special handling and disposal procedures. Onenote inserts in sequential order each page from. Structured product labelling of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section. 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. Cisplatin injection infusion concentrate is a clear, colorless, sterile aqueous solution available in amber vials.
This immunoglobulin preparation is produced by cold alcohol fractionation from the plasma of us donors. Reconstitute the 200 mg vialwith 5 ml and the 1 g vial with 25 ml of 0. Carboplatin has a carboxycyclobutane moiety replacing the chloride atoms on cisplatin. Camptosar is intended for dilution with 5% dextrose injection, usp d5w, or 0. The product catalog provides you with a full listing of tevas brand and generic product lines. Enhertu famtrastuzumab deruxtecannxki for injection, for intravenous use. Package insert of accord healthcares cisplatin injection. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea andor vomiting will occur postoperatively.
For healthcare professionals nerlynx neratinib tablets. Cisplatin injection rx only warning cisplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Percorten v novartis animal health us, inc veterinary. Gateway for healthcare professionals yervoy ipilimumab. Taxol contains paclitaxel, a natural product with antitumour activity. Immune globulin intravenous human igiv, carimune nf, nanofiltered, is a sterile, highly purified polyvalent antibody product containing in concentrated form all the igg antibodies which regularly occur in the donor population 1. Dose modifications dosage adjustments for hematologic toxicity may be required for gemcitabine for injection and for cisplatin. Etopophos has been as a single agent in clinical studies involving 206 patients with a used variety of malignancies including one hodgkins lymphomanon and in combination with cisplatin in 60 patients with smallcell lung cancer. Imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the firstline treatment of adult patients with extensivestage small cell lung cancer essclc. Taxol is the first of a new class of anticancer agents known as taxanes. The recommended dose of alimta when administered with cisplatin in patients with a creatinine clearance calculated by cockcroftgault equation of 45mlmin or greateris 500mgm2 as an intravenous infusion over 10minutes on day 1 of each 21day cycle until disease progression or unacceptable toxicity. Each vial contains equal parts by weight of carboplatin and mannitol. The primary objective of this trial was to compare survival between the 2 treatment groups.
Loss of vision, which can be complete for light and colors, has been reported after the use of carboplatin with doses higher than those recommended in the package insert. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. The prevention and treatment of postoperative nausea and vomiting in adults. Beovu brolucizumabdbll injection, for intravitreal injection. Each 50 ml, 100 ml or 200 ml amber vial of cisplatin injection contains. 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. Highlights of prescribing information these highlights do not. Cisplatin for injection can cause doserelated nephrotoxicity, including acute renal failure that becomes more prolonged and severe with repeated courses of the drug. Cisplatin for injection is contraindicated in patients with severe hypersensitivity to cisplatin see warnings and precautions 5. Close x yervoy ipilimumab is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older yervoy ipilimumab is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. Topotecan injection, in combination with cisplatin, is indicated for the treatment of stage ivb, recurrent or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery andor radiation therapy. Highlights of prescribing information initial dose of.
The preferred diluent is 5% dextrose injection, usp. Topotecan had no effect on the pharmacokinetics of free platinum in 15 patients with ovarian. The dose of cyclophosphamide when used in combination with cisplatin is 600 mgm2 iv once every 4 weeks day 1. Hepatotoxicity see full prescribing information for complete boxed warning. Jevtana is indicated in combination with prednisone for the treatment of patients with metastatic castrationresistant prostate cancer previously treated with a docetaxelcontaining treatment regimen. Highlights of prescribing information advanced renal cell. Highlights of prescribing information reduce the dose of. Intended use adenoplus is a rapid immunoassay test for the visual, qualitative in vitro detection of adenoviral antigens hexon pro. The pdfpages package makes it easy to insert pages of external pdf documents. Each vial of platinol contains 50 mg cisplatin, 450 mg sodium chloride, usp, and 500 mg mannitol, usp. Highlights of prescribing information these highlights. Carboplatin is a cisplatin analog with similar antineoplastic activity, but with a different adverse effect profile than cisplatin. Hycamtin for injection,in combination with cisplatin,is indicated for the treatment of patients with stage ivb, recurrent, or persistent cervical cancernot amenable to curative treatment.
See 17 for patient counseling information and fda approved patient labeling. Cisplatin 1 mgml sterile concentrate should be diluted in 2 litres of 0. The recommended dose of xalkori in patients with preexisting moderate hepatic impairment any aspartate aminotransferase ast and total bilirubin greater than 1. Carboplatin carboplatin this product information is intended only for residents of the united states. Do not save any unused portions for later administration. Prior to use of cisplatin may also result in a decrease of etoposide total body clearance in children. Visually inspect reconstituted product for particulate matter and discoloration. Nonsmall cell lung cancer the recommended dose of alimta is 500 mgm. Administration of cisplatin 60 or 75 mgm2 on day 1 before topotecan 0. Specifically, in one report of 2 children receiving concomitant cisplatin with bleomycin, total body clearance of bleomycin decreased from 39 to 18 mlmin 2 as the cumulative dose of cisplatin exceeded 300 mgm2. Reconstituted gemzar is a clear, colorless to light strawcolored solution. Gemzar vials contain no antimicrobial preservatives and are intended for single use only.
Highlights of prescribing information these highlights do not include all the information needed to use xtandi safely and effectively. This products label may have been revised after this insert was used in production. Immune globulin acute intravenous human carimune nf. Effect of prophylaxis or neratinib dose escalation on neratinibrelated diarrhea and tolerability in patients with her2positive earlystage breast cancer. Highlights of prescribing information initial dose of 4 mg. Each 50 ml or 100 ml amber vial of infusion concentrate contains.
Press the esc key to cancel the screen clipping procedure. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula ptcl. In combination therapy, cisplatin and cyclophosphamide are administered sequentially.
Carimune nf immune globulin intravenous human dose. Mononine fda prescribing information, side effects and uses. The product contains the identical amino acid sequence of isolated natural erythropoietin. Highlights of prescribing information platinumresistant. The differences in potencies for carboplatin, usp and cisplatin appear to be directly related to the.
Highlights of prescribing information posterior reversible. Despite this difference, it appears that both carboplatin, usp and cisplatin induce equal numbers of drugdna crosslinks, causing equivalent lesions and biological effects. Should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents. Discard unused portions of each vial properly see how suppliedstorage and handling 16. Tasigna nilotinib capsules, for oral use initial u. Terminal halflife of bleomycin also increased from 4. The recommended dosing schedule is 3 mgkg administered intravenously over a 90minute period every 3 weeks for a total of 4 doses1 assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as camptotheca acuminata or is. Dailymed amiodarone hydrochloride injection, solution.
Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. For further product information and current package insert, please visit. Patients should receive appropriate hydration prior to andor after receiving cisplatin. Two hundred and twelve patients received navelbine plus cisplatin and 210 received singleagent cisplatin. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product.
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