CEFTAROLINE PACKAGE INSERT PDF

For Injection: Teflaro is supplied as mg or mg of sterile ceftaroline fosamil powder in single-dose, 20 mL clear glass. There is minimal potential for drug-drug interactions between TEFLARO and CYP substrates, inhibitors, or inducers; drugs known to undergo active renal . To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEFLARO and other antibacterial drugs, TEFLARO should be used to.

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Please review Indications and Usage before proceeding.

Marketing authorisation holder 8. Renal cortical cysts were oberved in all groups, including controls, on PND In vitro susceptibility data are intended for healthcare professionals only.

Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil. Tabulated list of adverse reactions The following adverse reactions have been identified during clinical trials and post-marketing experience with Zinforo. To bookmark a medicine you must sign up and log in.

The effects of ceftaroline fosamil on fertility on humans have not been studied. The cysts involved a small portion of the kidney and ocurred in the absence of significant changes in either renal function or urinary parameters. The median steady-state volume of distribution of ceftaroline in healthy adult males following a single mg intravenous dose of radiolabelled ceftaroline fosamil was The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use.

Creatinine clearance CrCl estimated using the Cockcroft-Gault formula.

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Zinforo 600 mg powder for concentrate for solution for infusion

This site is intended for U. Intravenous bolus dosing of ceftaroline fosamil to suckling rats from post-natal day 7 to 20 was well tolerated at plasma exposures approximately 2-fold higher than those for paediatric patients.

Hepatic impairment The pharmacokinetics of ceftaroline in patients with hepatic impairment has not been established. However, the possibility that haemolytic anaemia may occur in association with cephalosporins including Zinforo treatment cannot be ruled out.

Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to ceftaroline in the absence of acquired mechanisms of resistance:. Request a representative now by filling out and sending the request form below. To view the changes to a medicine you must sign up and log in.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6. Therefore, these findings were not considered to be adverse. Reporting suspected adverse reactions after authorisation of the medicinal product is important. In vitro oackage have not demonstrated any antagonism between ceftaroline in combination with other commonly used antibacterial agents e.

Following administration throughout pregnancy and lactation in the rat, there was no effect on pakage birth weight or growth, although minor changes in foetal weight and delayed ossification of the interparietal bone were observed when ceftaroline fosamil was administered during organogenesis see section 5.

Brian, year-old male For illustrative purposes only.

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Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity at exposures similar to therapeutic concentrations. Arrived in ED with an abscess on the forearm that has worsened from a scrape. Powder for concentrate for solution for infusion powder for concentrate. Ceftarolien table of contents Hide table of contents 1. Infect Dis Clin Pract. By continuing to browse the site you are agreeing to our policy on the use of cookies. Serious and occasionally fatal hypersensitivity reactions are possible see sections 4.

The medicinal product is supplied in packs of 10 vials. Infusion time minutes b. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. Pregnancy There are no or limited amount of data from the use of ceftaroline fosamil in pregnant women.

ABSSSI & CABP IV Therapy | TEFLARO® (ceftaroline fosamil)

Limitations of the clinical data There is no experience with ceftaroline in the treatment of CAP in the following patient groups: As ceftaroline does not appear to undergo significant hepatic metabolism, the systemic clearance of ceftaroline is not expected to be significantly affected by hepatic impairment. Arrived in ED with an abscess due to inxert suspected spider bite on her left leg.

There are no clinical trial data regarding the use of ceftaroline to treat CAP due to S.