Mylan manufactures cisplatin injection cisplatin in strengths of 50 mg50 ml 1 mgml100 mg100 ml 1 mgml. Platinol cisplatin for injection, usp is a white to light yellow lyophilized powder. In combination therapy, cisplatin and cyclophosphamide are administered sequentially. The majority of patients receiving more than one cycle of treatment required dose adjustments. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the. For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert. For patients whose baseline counts are wbc leaflet. Hcl andor sodium hydroxide is added to adjust ph of the solution. Droperidol is contraindicated in patients with known or suspected qt prolongation i. The bleomycin for injection 15 units vial should be reconstituted with 1 to 5 ml of sterile water for injection, usp, sodium chloride for injection, 0. Cisplatin fda prescribing information, side effects and uses. Cisplatin injection is a clear, colorless, sterile aqueous solution. The name of your medicine is cisplatin 1 mgml concentrate for solution for infusion but in the rest of the leaflet it will be called cisplatin injection.
Pantoprazole has weakly basic and acidic properties. Should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents. Highlights of prescribing information these highlights do not include all the information needed to use lartruvosafely and effectively. Cisplatin for injectioncan cause doserelated nephrotoxicity, including acute renal failure that becomes more prolonged and severe with repeated courses of the drug. In general, for severe grade 3 or 4 nonhematological toxicity, except alopecia and nauseavomiting, therapy with gemcitabine for injection plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. As a single agent, cisplatin should be administered at a dose of 100 mgm2 iv per cycle once every four weeks. Small cell lung cancer, in combination with cisplatin, as firstline treatment.
Lartruvoolaratumabinjection, for intravenous use initial u. Sections or subsections omitted from the full prescribing information are not listed. Detailed dosage guidelines and administration information for platinolaq cisplatin. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula ptcl 2 h 6 n 2, and a molecular weight of 300. Cisplatin 1 mgml sterile concentrate should be diluted in 2 litres of 0. Cancerdrugcostsfora monthoftreatmentatinitialfood anddrugadministrationapproval. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula ptcl. Information for the user cisplatin 1mgml concentrate for solution for infusion cisplatin. Package insert of accord healthcares cisplatin injection. An instruction booklet for the preparation of drug suspension for injection is.
Each vial of platinol contains 50 mg cisplatin, 450 mg sodium chloride, usp, and 500 mg mannitol, usp. This would include patients with congenital long qt syndrome. Highlights of prescribing information these highlights do not include all the information needed to use per foromist inhalation solution safely and effectively. Cisplatin for injection is contraindicated in patients with severe hypersensitivity to cisplatin see warnings and precautions. Package insert of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section.
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. Droperidol is contraindicated in patients with known hypersensitivity to the drug. Cytoxan cyclophosphamide for injection, usp cytoxan. 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. Cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. Each vial of platinol contains 50 mg cisplatin, 450 mg sodium chloride. Full prescribing information, including boxed warnings fda approval letter. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Structured product labelling of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section. Patients in the gemzar cisplatin gc arm received a median of 5 cycles and those in the etoposide cisplatin ec arm received a median of 4 cycles. Each 50 ml, 100 ml or 200 ml amber vial of cisplatin injection contains.
Toxicological information the toxicological effects of this product have not been thoroughly studied. Cisplatin 1 mgml sterile concentrate summary of product. Gemcitabine for injection, powder, lyophilized, for solution for intravenous use. Appropriate management of therapy and complications is possible only when adequate. See full prescribing information for gemcitabine for injection. Platinol cisplatin for injection, usp should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. The bleomycin for injection 30 units vial should be reconstituted with 2 to 10 ml of the above diluents. Carboplatin, like cisplatin, produces predominantly interstrand dna crosslinks rather than dna. The dose of cyclophosphamide when used in combination with platinol is 600 mgm 2 iv once every 4 weeks day 1. See full prescribing information for perforomist inhalation solution. Cisplatin dosing, indications, interactions, adverse effects, and more.
Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at ph 7. Treatment of squamous cell carcinoma of the head and neck. Pantoprazole sodium sesquihydrate is a white to offwhite crystalline powder and is racemic. Includes dose adjustments, warnings and precautions. Highlights of prescribing information these highlights do not include all the information needed to use gemcitabine for injection safely and effectively. At the recommended dosage, platinol should not be given more frequently than once every 3 to 4 weeks see adverse.
693 1416 1173 1274 1313 396 265 1418 238 685 926 647 880 93 1472 139 1273 536 1234 552 1517 1054 213 1308 1303 1351 1326 104 884 1328 1324 733 1189 11 543 727 1353 243 1328 1346 455 209 1110