Cefazolin for injection, usp sagent pharmaceuticals. Search for clinical trials by condition, keyword or trial number. Highlights of prescribing information age group dosage. The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowishwhite to light yellow sterile powder. Learn about teflaro, an infusion therapy that may be prescribed to patients with absssi or cabp. Aug 24, 2018 ceftaroline package insert ebook download to reduce the development of drugresistant bacteria and maintain the effectiveness of teflaro and other antibacterial drugs, teflaro should be used to. Indicated surgical procedures should be performed in conjunction with flagyl therapy. Ceftaroline package insert ebook download to reduce the development of drugresistant bacteria and maintain the effectiveness of teflaro and other antibacterial drugs, teflaro should be used to. Cancidascaspofungin acetate for injection, for intravenous use initial u. Sep 24, 2019 teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate. Dailymed teflaro ceftaroline fosamil powder, for solution. Description azactam aztreonam injection contains the active ingredient aztreonam, a monobactam.
When possible, interrupt therapy with brilinta for fivedays prior to surgery that has a major risk of bleeding. Flagyl is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Zinforo, innceftaroline fosamil european medicines agency. Follow applicable special handling and disposal procedures.
Please see individual product label for storage instructions and product expiration date. Adjunctive ceftaroline in combination with daptomycin or. To reduce the development of drugresistant b acteria and maintain the effectiveness of. Downloading fda package insert for teflaro injection. Teflaro ceftaroline fosamil for injectiondistributed by. Dec 28, 2019 ceftaroline package insert pdf for injection. The chemical name is desalanyl1, serine125 human interleukin2. For solution and drug compatibility information, see compatibility under stability.
Sep 27, 2019 teflaro was evaluated in four controlled comparative phase 3 clinical trials two in absssi and two in cabp which included 0 adult patients treated with teflaro 600 mg administered by iv over 1 hour every 12h and 1297 patients treated with comparator vancomycin plus aztreonam or ceftriaxone for a treatment period up to 21 days. Reconstituted vials may be stored either refrigerated at 2 to 8 c 36 to 46 f, or at controlled room temperature 20 to 25 c 68 to 77 f. Highlights of prescribing information these highlights do not include all the information needed to use cubicin safely and effectively. Teflaro reference guide for safe and effective use from the american society of. Teflaro is administered every 8 hours by intravenous infusion over 30 to 60 minutes for patients less than 2 months of age. Teflaro dosing regimen is only recommended for patients with absssi. Csl behring immune globulin intravenous human, 10%. Its bioactive form, ceftaroline, is rapidly released in vivo upon hydrolysis of the phosphonate group 1, 3, 20, 23. Bar codes included on the vial and carton for ease of scanning. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Teflaro ceftaroline fosamil injection for intravenous iv.
Treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older see clinical studies 14. Cancidas has not been approved for the treatment of oropharyngeal candidiasis opc. Teflaro ceftaroline fosamil is indicated in adult and pediatric patients at least 34 weeks gestational age and 12 days postnatal age and older for the treatment of acute bacterial skin and skin structure infections absssi caused by susceptible isolates of the following grampositive and gramnegative microorganisms. It was originally isolated from chromobacterium violaceum. Description proleukin aldesleukin, a human recombinant interleukin2 product, is a highly purified protein with a molecular weight of approximately 15,300 daltons. There is minimal potential for drugdrug interactions between teflaro and cyp substrates, inhibitors, or inducers. When possible, interrupt therapy with brilinta for fivedays prior to. Teflaro ceftaroline fosamil powder, for solution dailymed. Patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, should not be. Contraindications warnings fluorouracil warnings see boxed. Share your location or enter your city or zip code to find studies near you.
The patient should also be monitored for discontinuation symptoms of the antidepressant see package insert of the specified agents for a description of the associated discontinuation symptoms. These patients should not be treated with forteo because of the possibility of exacerbating hypercalcemia. Highlights of prescribing information these highlights do not include all the information needed to use arzerra safely and effectively. Please also see full prescribing information for azactam. Jan 26, 2020 if you have any questions about teflaro ceftaroline fosamil, please talk with your doctor, nurse, pharmacist, or other health care provider. Ceftaroline package insert pdf wonderful australia. Aseptically transfer the required dose of reconstituted dalbavancin solution. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for teflaro ceftaroline. Some of the dosage forms listed on this page may not apply to the brand name teflaro in summary. Unreconstituted teflaro vials should be stored at 25c 77f. Aug 22, 2019 ceftaroline package insert pdf for injection. Teflaro ceftaroline fosamil for injection, for intravenous use. Teflaro is supplied as mg or mg of sterile ceftaroline fosamil powder in singledose, 20 ml clear glass.
Discover how to dose the 5 to 60 minute iv infusion of teflaro treatment for patients. To minimize excessive foaming, gently dissolve the mycamine powder by swirling the vial. Insert needle and inject all the liquid subcutaneously. Zinforo 600 mg powder for concentrate for solution for infusion. Before sharing sensitive information, make sure youre on a federal government site. Easytoread drug name and dosage strength to aid in identifying the right product.
Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of. If you think there has been an overdose, call your poison control center or get medical care right away. In the study that evaluated the efficacy of caspofungin in the treatment of. Request a representative now by filling out and ceftarlline the request form below. This document contains side effect information about ceftaroline. Patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, should not be treated with forteo.
Teflaro ceftaroline fosamil prescribing information. Summary of ceftaroline activity against pathogens in the. Food and drug administration, center for drug evaluation and research. Ceftaroline fosamil teflaro is an nphosphonoamino watersoluble prodrug cephalosporin with the active form, ceftaroline, possessing broadspectrum in vitro antimicrobial activity. The text of a patient information sheet is printed at the end of this insert. Teflaro and other antibacterial drugs, teflaro should be used only to treat infections. Ceftaroline is administered as a prodrug ceftaroline fosamil that is rapidly dephosphorylated in the blood to the active form. Announces fda approval of fluocinonide cream usp, 0. Treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without. Concentrations of teflaro in the cerebrospinal fluid have not been evaluated see use in specific.
The reconstituted vial contains 20 mgml dalbavancin as a clear, colorless to yellow solution. Teflaro ceftaroline fosamil forest laboratories, inc. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to flagyl. Highlights of prescribing information extended treatment in. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for teflaro ceftaroline skip to. Etopophos solutions may be administered at infusion rates up to 3. Teflaro ceftaroline fosamil injection for intravenous iv use. Concentrations of teflaro in the cerebrospinal fluid have not. Teflaro is also indicated in ceftaroline package insert and pediatric patients 2 months of age and older for the treatment of communityacquired bacterial pneumonia cabp caused by susceptible isolates of the following grampositive and gramnegative microorganisms. Immediately slide green safety guard over needle with the needle pointing away from you. Forteo has not been studied in patients with preexisting hypercalcemia.
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