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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Reasons for being admitted to the hospital through the emergency department, The following adverse reactions have been identified during clinical trials and post-marketing experience with Zinforo. Animal studies with ceftaroline pac,age do not indicate harmful effects with respect to fertility see cettaroline 5. Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite, ceftaroline M Non-susceptible organisms Superinfections may occur during or following paackage with Zinforo.

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: As a precautionary measure, it is preferable to avoid the use of Zinforo during pregnancy unless the clinical condition of the woman requires treatment with an antibiotic with Zinforo’s antibacterial profile.

Zinforo 600 mg powder for concentrate for solution for 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: Show table of contents Hide table of contents 1.

Arrived in ED with ceftaro,ine and extensive cellulitis on right leg.

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Please see individual product label for storage instructions and product expiration date. Zinforo powder should be reconstituted with 20 ml of sterile water for injections. Zinforo is indicated for the treatment of the following infections in adults and children from the age of 2 months see sections 4.

For the full list of excipients, see section 6. Day 4 clinical response of ceftaroline fosamil versus ceftriaxone for community-acquired bacterial pneumonia.

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

Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to 5 times the observed clinical exposure. Standard aseptic techniques should be used for solution preparation and administration.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to cceftaroline empiric selection of therapy. Pyrexia, infusion site reactions erythema, phlebitis, pain. In vitro susceptibility data are intended for healthcare professionals only.

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:. Anaphylaxis see sections 4.

TEFLARO® (ceftaroline fosamil) Dosing Information

See Dosing for Pediatric Patients. 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. Store in the original package in order to protect from light.

The cysts involved a small portion of the insrrt and ocurred in the absence of significant changes in either renal function or urinary parameters. 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. In pooled human liver microsomes, metabolic turnover was low for inxert, indicating that ceftaroline is not metabolised by hepatic CYP enzymes.

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Patients experiencing anaemia during or after treatment with Zinforo should be investigated for this possibility. ESRD, including haemodialysis b. Packaye median steady-state volume of distribution of ceftaroline in healthy adult males following a single mg intravenous dose of radiolabelled ceftaroline fosamil was Other important toxicologic findings noted packafe the rat and monkey included histopathologic changes in the bladder and spleen.

Therefore, no dosage adjustment is recommended for patients with hepatic impairment. This medicinal product must not be mixed with other medicinal products ceftaroilne those mentioned in section 6. Direct antiglobulin test Coombs test seroconversion and potential risk of haemolytic anaemia The development of a positive direct antiglobulin test DAGT may occur during treatment with cephalosporins.

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

Caution is advised when treating such patients. To view the changes to a medicine you must sign up and log in. Infusion time minutes c. Weight-based dosing is required for pediatric patients.

Serious and occasionally fatal hypersensitivity reactions are possible see sections 4. Treatment of overdose should follow standard medical practice.

Limited data in patients receiving higher than recommended Zinforo dosages show similar adverse ceftarollne as observed in the patients receiving recommended dosages. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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