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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Each vial contains ceftaroline cfftaroline acetic acid solvate monohydrate equivalent to mg ceftaroline fosamil. Zinforo is indicated for the treatment of the following infections in adults and children from the age of 2 months see sections 4. Consideration should be given to official guidance on the appropriate use of antibacterial agents. ESRD, including haemodialysis b. CrCL should be closely monitored and the dose adjusted according to changing renal function.

No dosage ceftarkline is considered necessary in patients with hepatic impairment see section 5. The safety and efficacy of Zinforo in children below the age of 2 months have not yet been established.

No data are available. Zinforo is administered by intravenous infusion over 60 minutes or minutes for all infusion volumes 50 ml, ml or ml see section 6. Infusion volumes for paediatric patients will vary according to the weight of the child.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6. Immediate and severe hypersensitivity e. Serious and occasionally fatal hypersensitivity reactions are possible see sections 4.

Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil.

Ceftaroline should be used with caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam antibiotics e. If a severe allergic reaction occurs during treament with Zinforo, the medicinal product should be discontinued and appropriate measures taken.

Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftaroline fosamil and may range in severity from mild to life threatening.

Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftaroline fosamil see section 4. In 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.

Seizures have occurred in toxicology studies at times human ceftaroline C max levels see section 5.

Clinical study experience with ceftaroline fosamil in patients with pre-existing seizure disorders is very limited. Therefore, Zinforo should be used with caution in this patient population. 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. The incidence of DAGT seroconversion in patients receiving ceftaroline fosamil was In clinical studies there was no evidence of haemolysis in patients who developed a positive DAGT on treatment. However, the possibility that haemolytic anaemia may occur in association with cephalosporins including Zinforo treatment cannot be ruled out.

Patients experiencing anaemia during or after treatment with Zinforo should be investigated for this possibility. There is no experience with ceftaroline in the treatment of CAP in the following patient groups: Caution is advised when treating such patients.

There is no experience with ceftaroline in the treatment of cSSTI in the following patient groups: There is limited experience in treating patients with diabetic foot infections.

TEFLARO® (ceftaroline fosamil) Dosing Information

The interaction potential of ceftaroline or ceftaroline fosamil on medicinal products metabolised by CYP enzymes is expected to be low since they are not inhibitors packafe inducers of CYP enzymes in vitro.

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. Therefore, interactions of ceftaroline with medicinal products that are substrates or inhibitors e.

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There are no or ceftaroine amount of data from the use of ceftaroline fosamil in pregnant women. Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity at exposures similar to therapeutic concentrations.

Following administration throughout pregnancy and lactation in the rat, there was no effect on pup 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. 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.

It ceftaroliine unknown whether ceftaroline fosamil or ceftaroline is excreted in human milk. The effects of ceftaroline fosamil on fertility on humans have not been studied. Animal studies with ceftaroline fosamil do not indicate harmful effects with respect to fertility see section 5. CDAD and severe hypersensitivity reactions may also occur. A greater incidence of rash in Asian patients see below and a greater incidence of DAGT seroconversion ceftarkline section 4.

The following adverse reactions have been identified during clinical trials and post-marketing experience with Zinforo. Adverse reactions are classified according to System Organ Class and frequency. Frequency categories are derived according to the following conventions: Table 5 Frequency of adverse reactions by system organ class from clinical trials and post-marketing experience.

Anaemia, leucopenia, neutropenia, thrombocytopenia, prothrombin time PT prolonged, activated partial thromboplastin time aPTT prolonged, international normalized ratio INR increased. Anaphylaxis see sections 4. Rash was observed at a common frequency in both the pooled Phase III studies in cSSTI nisert administration of Zinforo every 12 hours mg administered over 60 minutes every 12 hours and the study in cSSTI with administration every ppackage hours mg administered over minutes every 8 hours.

However, the frequency of rash in the subgroup of Asian patients receiving Zinforo every 8 hours was very common The safety assessment in children is based on the safety data from 2 trials in which paediatric patients aged from 2 months to 17 years with cSSTI or CAP received Zinforo. Overall, the safety profile in these children was similar to that observed in the adult population.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Limited data in patients receiving higher than recommended Zinforo dosages show similar adverse reactions as observed in the patients receiving recommended dosages.

Relative overdosing could occur in patients with moderate renal impairment. Treatment of overdose should follow standard medical practice.

Antibacterials for systemic use, other cephalosporins and penems, ATC code: 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.

As a result, minimum inhibitory concentrations MICs of ceftaroline against a proportion of these organisms tested fall into the susceptible imsert see Resistance section below.

Organisms that express these enzymes and which are therefore resistant to ceftaroline occur at very variable rates between countries and between healthcare facilities within countries. If ceftaroline is commenced before susceptibility test results are available then local information on the risk of encountering organisms that express these enzymes should be taken into consideration.

Resistance may also be mediated by bacterial impermeability or drug efflux pump mechanisms. One or more of these mechanisms may co-exist in a single bacterial isolate. In vitro studies have not demonstrated any antagonism between ceftaroline in combination with other commonly used antibacterial agents e.

Refers to dosing of adults or adolescents from 12 years inseet 33 kg with ceftaroline every 12 hours using 1-hour infusions see section 4. There are no clinical trial data regarding the use of ceftaroline to treat CAP due to S. Refers to dosing of adults or adolescents from 12 years and 33 kg with ceftaroline every 8 hours using 2-hour infusions to treat cSSTI cegtaroline section 4. 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.

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Efficacy has been packagr in clinical studies against the pathogens listed under each pacage that were susceptible to ceftaroline in vitro.

Zinforo 600 mg powder for concentrate for solution for infusion

The available clinical data cannot substantiate efficacy against penicillin non-susceptible strains of S. 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:.

The C max and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to mg. The median steady-state volume of distribution of ceftaroline in healthy adult males following a single mg intravenous dose of radiolabelled ceftaroline fosamil was 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.

Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite, ceftaroline M In pooled human liver microsomes, metabolic turnover was low for ceftaroline, indicating that ceftaroline is not metabolised by hepatic CYP enzymes.

Ceftaroline is primarily eliminated by the kidneys. Renal clearance of ceftaroline is approximately equal, or slightly lower than the glomerular filtration rate in the kidney, and in vitro transporter studies indicate that active secretion does not contribute to the renal elimination of ceftaroline.

The mean terminal elimination half-life of ceftaroline in healthy adults is approximately 2. The pharmacokinetics of ceftaroline in patients with hepatic impairment has not been established. 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. Therefore, no dosage adjustment is recommended for patients with hepatic impairment. The kidney was the primary target organ of toxicity in both the monkey and rat.

Histopathologic findings included pigment deposition and inflammation of the tubular epithelium. Renal changes were not reversible but were reduced in severity following a 4 week recovery period.

Other important toxicologic findings noted in the rat and monkey included histopathologic changes in the bladder and spleen. 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.

Furthermore, in vivo micronucleus assays in rat and mouse were negative. Carcinogenicity studies have not been conducted. Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to 5 times the observed clinical exposure. 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.

However, when ceftaroline was administered throughout pregnancy and lactation, there was no effect on pup weight or growth. 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.

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.

Renal cortical cysts were oberved in all groups, including controls, on PND The cysts involved a small portion of the kidney and ocurred in the absence of significant changes in either renal function or urinary parameters.