28 Carboplatin Fda Label
Carboplatin injection multidose vials maintain microbial chemical and physical stability for up to 14 days at 25c following multiple needle entries. Each ml contains 10 mg carboplatin and water for injection usp.
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Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
carboplatin fda label. It is used with other chemotherapy as first line treatment. Ovarian cancer that is advanced. Paraplatin carboplatin aqueous solution injection is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum containing compounds.
May enhance the ototoxic effect of carboplatin. Carboplatin injection is supplied as a sterile pyrogen free 10 mgml aqueous solution of carboplatin usp. Carboplatin injection is supplied as a sterile pyrogen free aqueous solution available in 50 mg5 ml 150 mg15 ml 450 mg45 ml or 600 mg60 ml multi dose vials containing 10 mgml of carboplatin for administration by intravenous infusion.
Fda label information for this drug is available at dailymed. Especially with higher doses of carboplatin. Multidose vials are stable for up to 14 or 15 days after opening when stored at 25c 77f following multiple needle entries refer to specific product labeling for stability information.
All of the platinum in the 24 hour urine is present as carboplatin. Carboplatin usp is a platinum coordination compound. Each ml contains 10 mg carboplatin usp 10 mg mannitol and water for injection usp.
Carboplatin is approved to be used alone or with other drugs to treat. The major route of elimination of carboplatin is renal excretion. Patients with creatinine clearances of approximately 60 mlmin or greater excrete 65 of the dose in the urine within 12 hours and 71 of the dose within 24 hours.
Due to inconsistencies between the drug labels on dailymed and the pill images provided by rximage we no longer display the rximage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. It is used alone as palliative treatment for disease that has recurred come back after earlier chemotherapy.
Solutions for infusion should be discarded 8 hours after preparation. Paraplatin should not be employed in patients with severe bone marrow depression or significant bleeding.
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