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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Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity at exposures similar to therapeutic concentrations. Qualitative and quantitative composition 3.

Preparation of Solutions for Adults

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. J01DI02 The active moiety after Zinforo administration is ceftaroline. Weight-based dosing is required for pediatric patients. Zinforo mg powder for concentrate for solution for infusion.

Use the same diluent used for constitution of the powder for this further dilution, unless sterile water for injection was used earlier. Biotransformation 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. Please confirm that pckage are a healthcare professional in the United States.

Amount to Be Withdrawn. Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to 5 times the observed clinical exposure. Streptococcus pneumoniae including cases with concurrent bacteremiaStaphylococcus aureus methicillin-susceptible isolates onlyHaemophilus influenzaeKlebsiella pneumoniaeKlebsiella oxytocaand Escherichia coli.

I prefer to be contacted by: The available clinical data cannot substantiate efficacy against penicillin non-susceptible strains of S.

TEFLARO® (ceftaroline fosamil) Dosing Information

Active ingredient ceftaroline fosamil. Find out more here. However, the frequency of rash in the subgroup of Asian patients receiving Zinforo every 8 hours was very common Show table of contents Hide table of contents 1. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

This site is intended for U. Each vial is for single use only. There are no or limited amount of data from the use of ceftaroline fosamil in pregnant women. Susceptibility data should be considered in conjunction with clinical trial data also presented on this website.

CrCL should be closely monitored and the dose adjusted according to changing renal function. 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.

Infusion time minutes c. Tabulated list of adverse reactions The following adverse reactions have been identified during clinical trials and post-marketing experience with Zinforo.

Refers to dosing of adults or adolescents from 12 years and 33 kg with ceftaroline every 12 hours using 1-hour infusions see section 4.

Cellulitis For illustrative purposes only. Streptococcus pneumoniae including cases with concurrent bacteremiaStaphylococcus aureus methicillin-susceptible isolates only ceftarloine, Haemophilus influenzaeKlebsiella pneumoniaeKlebsiella oxytocaand Escherichia coli.

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Zinforo 600 mg powder for concentrate for solution for infusion

After reconstitution, 1 ml of the solution contains 30 mg of ceftaroline fosamil. Reasons for being admitted to the hospital through the emergency department, The reconstituted solution is a pale yellow solution that is free of any particles. Once removed from refrigeration to room temperature, the diluted product must be used within 6 hours. Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to ceftaroline in vitro.

Accessed August 11, 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 inzert DNA synthesis assay.

Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible see sections 4. 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. In pooled human liver microsomes, metabolic turnover ceftaeoline low for ceftaroline, indicating that ceftaroline is not metabolised by hepatic CYP enzymes.

Complains of fever, cough with pleuritic chest pain, sputum production, occasional blood streaks in sputum within the past couple of days. Please confirm that you are a healthcare professional in the United States. Seizures have occurred in toxicology studies at times human ceftaroline C max levels see section 5.

Therefore, no dosage adjustment is recommended for patients with hepatic impairment. General disorders and administration site conditions.

Non-susceptible organisms Superinfections may occur during or following treatment with Zinforo. Therefore, Zinforo should be used with caution in this patient population. Volume of Diluent to Be Added mL.

If you are a patient, and have any questions, please discuss them with your doctor or healthcare professional. The mean terminal elimination half-life of ceftaroline in healthy adults is approximately 2.