Platinol package insert pdf

Platinol cisplatin for injection, usp is a white to light yellow lyophilized powder. Cisplatin dosing, indications, interactions, adverse effects, and more. Cisplatin 1 mgml sterile concentrate should be diluted in 2 litres of 0. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Should be administered only by or under the direct supervision of a qualified physician who is 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. Cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. In combination therapy, platinol and cyclophosphamide are administered sequentially. Cisplatin injection is a clear, colorless, sterile aqueous solution. Cisplatin 1 mgml sterile concentrate summary of product. Small cell lung cancer, in combination with cisplatin, as firstline treatment. Gemcitabine for injection, powder, lyophilized, for solution for intravenous use. This would include patients with congenital long qt syndrome.

Sections or subsections omitted from the full prescribing information are not listed. See full prescribing information for perforomist inhalation solution. 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. An instruction booklet for the preparation of drug suspension for injection is. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the. In combination therapy, cisplatin and cyclophosphamide are administered sequentially. Cancerdrugcostsfora monthoftreatmentatinitialfood anddrugadministrationapproval.

Droperidol is contraindicated in patients with known hypersensitivity to the drug. 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. See full prescribing information for gemcitabine for injection. At the recommended dosage, platinol should not be given more frequently than once every 3 to 4 weeks see adverse. Each 50 ml, 100 ml or 200 ml amber vial of cisplatin injection contains. Hcl andor sodium hydroxide is added to adjust ph of the solution. Information for the user cisplatin 1mgml concentrate for solution for infusion cisplatin. Lartruvoolaratumabinjection, for intravenous use initial u. Package insert of accord healthcares cisplatin injection.

Droperidol is contraindicated in patients with known or suspected qt prolongation i. Toxicological information the toxicological effects of this product have not been thoroughly studied. Highlights of prescribing information these highlights do not include all the information needed to use gemcitabine for injection safely and effectively. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at ph 7. 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. For patients whose baseline counts are wbc leaflet. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula ptcl. Full prescribing information, including boxed warnings fda approval letter. Package insert of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section. 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. 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 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. The dose of cyclophosphamide when used in combination with platinol is 600 mgm 2 iv once every 4 weeks day 1. As a single agent, cisplatin should be administered at a dose of 100 mgm2 iv per cycle once every four weeks. Highlights of prescribing information these highlights do not include all the information needed to use per foromist inhalation solution safely and effectively. Each vial of platinol contains 50 mg cisplatin, 450 mg sodium chloride, usp, and 500 mg mannitol, usp. Treatment of squamous cell carcinoma of the head and neck.

Structured product labelling of accord healthcares cisplatin injection, 1 mgml, 50 ml and 100 ml is enclosed in this section. Pantoprazole sodium sesquihydrate is a white to offwhite crystalline powder and is racemic. 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. Stable if stored in accordance with information listed on the product insert. Includes dose adjustments, warnings and precautions. Highlights of prescribing information these highlights do not include all the information needed to use lartruvosafely and effectively.

Cytoxan cyclophosphamide for injection, usp cytoxan. For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert. Pantoprazole has weakly basic and acidic properties. Each vial of platinol contains 50 mg cisplatin, 450 mg sodium chloride. 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 injection rx only warning cisplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. The majority of patients receiving more than one cycle of treatment required dose adjustments. Product profile mylan better health for a better world.

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