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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Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: ESRD, including haemodialysis b. As a result, minimum inhibitory concentrations MICs of ceftaroline against a proportion of these organisms tested fall into the susceptible range see Resistance section below. Therefore, interactions of ceftaroline with medicinal products that are substrates or inhibitors e. One or more of these mechanisms may co-exist in a packwge bacterial isolate.
There is no experience with ceftaroline in the treatment of pacakge in the following patient groups: Infect Dis Clin Pract. Hepatic impairment The pharmacokinetics of ceftaroline in patients with hepatic impairment has not been established. Sign Up Log In Cancel. Hypersensitivity to the cephalosporin class of antibacterials.
Hypersensitivity to the active substance or to any of the excipients listed in section 6. Seizures have occurred in toxicology studies at times human veftaroline C max levels see section 5.
TEFLARO® (ceftaroline fosamil) Dosing Information
Please also see full Prescribing Information. The kidney was the primary target organ of toxicity in both the monkey and rat. By continuing, you are confirming that you have read the Indications and Usage. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Patient reports pain, swelling, and discharge at the site of incision 3 days after undergoing surgery. Immediate and severe hypersensitivity e.
Ceftarolibe dosage adjustment is considered necessary in patients with hepatic impairment see section 5. Request a representative now by filling out and sending the request form below. Complains of fever, productive cough, and sputum more copious than with her usual COPD flare-ups for the past 3 days.
Iinsert such circumstance, the discontinuation of therapy with ceftaroline fosamil and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
Zinforo 600 mg powder for concentrate for solution for infusion
There is no experience with ceftaroline in the treatment of CAP in the following patient groups: Clostridium difficile colitis see section 4. Ceftaroline or ceftaroline fosamil are not metabolised by CYP enzymes in vitrotherefore co-administered CYP inducers or inhibitors are unlikely to influence the pharmacokinetics of ceftaroline.
No data are available. Juvenile toxicity 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.
The mean terminal elimination half-life of ceftaroline in healthy adults is approximately 2. Consideration should be given to official guidance on the appropriate use of antibacterial agents. When ceftaroline was administered during organogenesis, minor changes in foetal weight and delayed ossification of the interparietal bone were observed in the rat at exposures below that observed clinically. Zinforo mg powder for concentrate for solution for infusion.
After reconstitution, 1 ml of the solution contains 30 mg of ceftaroline fosamil.
In vitro results do not necessarily correlate with how the antibiotic will work in people. Ceftaroline should be used with caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam antibiotics e.
In pooled human liver microsomes, metabolic turnover was low for ceftaroline, indicating that ceftaroline is not metabolised by hepatic CYP enzymes. Resistance may also be mediated by bacterial impermeability or drug efflux pump mechanisms. Once the intravenous solution is prepared with diluents listed in section 6.
If you are a patient, and have any questions, please discuss them with your doctor or healthcare professional. Paediatric population As with adults, the interaction potential is expected to be low in paediatrics. PK-PD analyses suggest that dosing of adults or adolescents from 12 years and 33 kg with ceftaroline every 8 hours using 2-hour infusions may treat cSSTI due to S.
Infect Dis Clin Pract. Renal changes were not reversible but were reduced in severity following a 4 week recovery period.
