Cardene iv package insert
[PDF File]Intravenous Nicardipine Quick Reference Cardene
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Initiate therapy at 5 mg/hour as a continuous IV infusion. The initial infusion rate of 5mg/hr IV may be increased by 2.5 mg/hr every 5 minutes to a maximum of 15 mg/hr, to maintain a SBP less than 220 mm Hg and DBP
[PDF File]DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
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use presentations of the currently marketed Cardene IV ampul after dilution. We have completed our review of this application, as amended, and it is approved, effective on the ... must be identical to the package insert submitted on March 25, 2008 and the immediate container and carton labels submitted on May 7, 2008. We highly encourage you to ...
[PDF File]Reference ID: 3597784
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See full prescribing information for CARDENE IV. CARDENE IV (nicardipine hydrochloride) premixed injection, for intravenous use Initial U.S. Approval: 1988 _____ INDICATIONS AND USAG E • Cardene I.V. Premixed Injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. ...
[PDF File]CARDENE - Food and Drug Administration
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CARDENE significantly increased time to angina, total exercise duration and time to 1 mm ST segment depression. Included among these four studies was a dose-definition study in which dose-related improvements in exercise tolerance at 1 and 4 hours postdosing and reduced frequency of anginal attacks were seen at doses of
[PDF File]Injection: 200 mL nicardipine (0.2 mg/mL) in sodium chloride (0.8%) in ...
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CARDENE IV (nicardipine hydrochloride in dextrose injection ) for intravenous use CARDENE IV (nicardipine hydrochloride in sodium chloride injection), for intravenous use Initial U.S. Approval: 1988 _____INDICATIONS AND USAGE • Cardene I.V. Premixed Injection is a calcium channel blocker indicated for the short-term treatment of hypertension ...
[PDF File]I.V. Premixed Injection (0.1 mg/mL) in either 4.8% Dextrose or 0.86% ...
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Administer Cardene IV by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.7)]. Cardene I.V. Premixed Injection is available as a single-use, ready-to-use, iso-osmotic solution for intravenous administration. No further dilution is ...
[PDF File]Package Insert - Privigen - Food and Drug Administration
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Package Insert (218859)_Version 56 CONFIDENTIAL Page 3 of 30 CSL Behring Immune Globulin Intravenous (Human), 10% Liquid, Privigen 1.14.1.3 Draft Labeling Text
[PDF File]HIGHLIGHTS OF PRESCRIBING INFORMATION - Baxter PI
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IV administration of cardiodepressant calcium-channel antagonists (e.g.,verapamil) and BREVIBLOC injection in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving BREVIBLOCinjectionand intravenous verapamil.
[PDF File]Intravenous Nicardipine - EMCrit Project
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The tolerability of IV nicardipine in children or pregnant women has not been established in well designed trials. However, IV nicardipine was generally well tolerated in small, open-label studies in these patients. 1. Introduction An IV formulation of nicardipine (Cardene ® IV)1 has been approved in the US for the short-term
[PDF File]AMIODARONE HYDROCHLORIDE INJECTION
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IV Oral Formulation SCL QRS QTc AH IV Oral Rx only This product’s label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.APPpharma.com or call our medical information and safety department toll-free at 1-800-551-7176.
[PDF File]HIGHLIGHTS OF PRESCRIBING INFORMATION infusion. When blood pressure and ...
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CARDENE®I.V.(nicardipine hydrochloride) is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1)]. 2DOSAGE AND ADMINISTRATION
BCG Live Package Insert - Food and Drug Administration
BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration.
DILTIAZEM HYDROCHLORIDE INJECTION Rx ONLY DESCRIPTION
infusion. Total radioactivity measurement following short IV administration in healthy volunteers suggests the presence of other unidentified metabolites which attain higher concentrations than those of diltiazem and are more slowly eliminated; half-life of total radioactivity is about 20 hours compared to 2 to 5 hours for diltiazem.
[PDF File]HIGHLIGHTS OF PRESCRIBING INFORMATION - Food and Drug Administration
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Initial Infusion rate . Maintenance Infusion rate : Intravenous Administration . PI : 300 to 600 mg/kg every 3 to 4 weeks based on clinical response. 0.5 mL/kg/hr
[PDF File]CARDENE® SR - Food and Drug Administration
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Cardene SR also has somewhat lower bioavailability than CARDENE except at the highest dose. Minimum plasma levels produced by equivalent daily doses are similar. Cardene SR thus exhibits significantly reduced fluctuation in plasma levels in comparison to CARDENE capsules. When Cardene SR was administered with a high-fat breakfast, mean C
[PDF File]Nicardipine Hydrochloride Injection - USP–NF
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ADDITIONAL REQUIREMENTS • PACKAGING AND STORAGE: Preserve in single-dose amber glass vials. • LABELING: Label it to indicate that it is to be diluted to the appropriate strength with a suitable intravenous fluid prior to administration. Change to read: • USP REFERENCE STANDARDS á11ñ USP N-Benzyl-N-methyl-ethanolamine RS 2-[Benzyl(methyl)amino]ethanol.
Baxter Healthcare Corporation CARDENE IV- nicardipine hydrochloride ...
These highlights do not include all the information needed to use CARDENE IV safely and effectively. See full prescribing information for CARDENE IV. CARDENE IV (nicardipine hydrochloride in dextrose injection) for intravenous use CARDENE IV (nicardipine hydrochloride in sodium chloride injection), for intravenous use Initial U.S. Approval: 1988
[PDF File]CYTOVENE -IV (ganciclovir sodium for injection) FOR INTRAVENOUS ...
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1 1 2 cytovene -iv 3 (ganciclovir sodium for injection) 4 for intravenous infusion only 5 6 rx only 7 warning 8 the clinical toxicity of cytovene-iv includes 9 granulocytopenia, anemia and thrombocytopenia. in animal 10 studies ganciclovir was carcinogenic, teratogenic and 11 caused aspermatogenesis. 12 cytovene-iv is indicated for use only in the treatment of
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