CEFTAROLINE PACKAGE INSERT PDF

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEFLARO and other antibacterial drugs, TEFLARO should be used to. There is minimal potential for drug-drug interactions between TEFLARO and CYP substrates, inhibitors, or inducers; drugs known to undergo active renal . Learn about the proper solution preparation techniques for TEFLARO® before When stored as recommended, the product potency is not affected. Parenteral.

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Zinforo 600 mg powder for concentrate for solution for infusion

In vitro studies have shown that ceftaroline is bactericidal and able to inhibit bacterial cell wall synthesis in methicillin-resistant Staphylococcus aureus MRSA and penicillin non-susceptible Streptococcus pneumoniae PNSP due to its affinity for the altered penicillin-binding proteins PBPs found in these organisms. 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.

TEFLARO is also indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia CABP caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: By continuing, you are confirming that you have read the Indications and Usage.

Seizures have occurred in toxicology studies at times human ceftaroline C max levels see section 5. Constitution time is less than 2 minutes. Accessed August 11, Dosage and Administration Dosage and Administration Preparation of Solutions Dosing The minute infusion allows increased flexibility of infusion time See dosing. Ceftaroline fosamil and ceftaroline were clastogenic in an in vitro chromosomal aberration assay, however there was no evidence of mutagenic activity in an Ames test, mouse lymphoma and unscheduled DNA synthesis assay.

Back to top Pfizer Limited contact details. Patients with pre-existing seizure disorder Seizures have occurred in toxicology studies at times human ceftaroline C max levels see section 5. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amount to Be Withdrawn. Last updated on eMC: The safety and efficacy of Zinforo in children below the age of 2 months have not yet been established.

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Please confirm that you are a healthcare professional in the United States. Ceftaroline should be used with caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam antibiotics e. Pakage of fever, productive cough, and sputum more copious than with her usual COPD flare-ups for the past 3 days.

By continuing, you are confirming that you have read the Indications and Usage. Date nisert first authorisation: Ceftaroline fosamil prodrug is converted into the active ceftaroline in plasma by phosphatase enzymes and concentrations of the prodrug are measurable in plasma primarily during intravenous infusion.

TEFLARO is also indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia CABP caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Qualitative and quantitative composition 3. Increased flexibility of infusion time Questions to consider What impact could the 5-minute infusion have on the daily indert of these infections in your hospital?

By continuing, you are confirming that you have read the Indications and Usage. The incidence of DAGT seroconversion in patients receiving ceftaroline fosamil was Resistance may also inaert mediated by bacterial impermeability or drug efflux pump mechanisms.

Preparation of Solutions for Adults

Genetic toxicology Ceftaroline fosamil and ceftaroline were clastogenic in an in vitro chromosomal aberration assay, however there was no evidence of mutagenic activity in an Ames test, mouse lymphoma and unscheduled DNA synthesis assay. See Dosing for Inserf Patients. Renal cortical cysts were oberved in all groups, including controls, on PND Refers to dosing of adults or adolescents from 12 years and 33 kg with ceftaroline every packwge hours using 1-hour infusions see section 4.

J01DI02 The active moiety after Zinforo administration is ceftaroline. Dosage and Administration Dosage and Administration Preparation of Solutions Dosing The minute infusion allows increased flexibility of infusion time See dosing.

Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity at exposures similar to therapeutic concentrations. Please also see full Prescribing Information. Interaction with other antibacterial agents In vitro studies have not demonstrated any antagonism between ceftaroline in combination with other commonly used antibacterial agents e.

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Arrived in ED with an abscess on the forearm that has worsened from a scrape. Standard aseptic techniques ceftaroine be used for solution preparation and administration.

Please review Indications and Usage before proceeding. Name of the medicinal product 2. Overall, the safety profile in these children was similar to that observed in the adult population.

Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible see sections 4.

The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes. In vitro susceptibility data are intended for healthcare professionals only. Limitations of the clinical data Ceftarolins is ceftarloine experience with ceftaroline in the treatment of CAP in the following patient groups: There is minimal feftaroline for drug-drug interactions between TEFLARO and CYP substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.

Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to pacjage times the observed clinical exposure. CDAD and severe hypersensitivity reactions may also occur. 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. There is no experience with ceftaroline in the treatment of cSSTI in the following patient groups: Ceftaroline administration to pregnant rabbits resulted in an increased foetal incidence of angulated hyoid alae, a common skeletal variation in rabbit fetuses, at exposures similar to those observed clinically.

TEFLARO® (ceftaroline fosamil) Dosing Information

Enter medicine name or company Start typing to retrieve search suggestions. Clinical study experience with ceftaroline fosamil in patients with pre-existing seizure disorders is very limited. Volume of Diluent to Be Added mL.