Non-species related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species. In rabbits, reduced fetal body weight occurred only in the presence of maternal toxicity (clinical signs, reduced body weight gain and food consumption) at low exposure levels 0.06 times compared to the expected human exposure based on AUCs.

Therefore, adolescents administered 600 mg every 12 hours daily will have similar exposure to that observed in adults receiving the same dosage.In paediatric patients with ventriculoperitoneal shunts who were administered linezolid 10mg/kg either 12 hourly or 8 hourly, variable cerebrospinal fluid (CSF) linezolid concentrations were observed following either single or multiple dosing of linezolid.

for clinical efficacy, safety and tolerability.

Clinical assessment at longterm follow-up Larger comparator controlled studies Therapeutic concentrations were not consistently achieved or maintained in the CSF. The ratio for epithelial lining fluid and alveolar cells of the lung was 4.5:1.0 and 0.15:1.0, when measured at steady-state Cmax, respectively. rate 18.2%. those with intolerance or nonresponsiveness to other potentially

diabetic foot (18%), sternal wound (14.5%) and vertebral Therefore, linezolid is not recommended for use in these circumstances unless close observation and monitoring of the recipient is possible (see sections 4.3 and 4.5).Patients should be advised against consuming large amounts of tyramine rich foods (see section 4.5).The effects of linezolid therapy on normal flora have not been evaluated in clinical trials.The use of antibiotics may occasionally result in an overgrowth of non-susceptible organisms. They are for use only for organisms that have not been given a specific breakpoint and not for those species where susceptibility testing is not recommended.The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.

Daptomycin doses of 25 and 15 mg/kg in the rabbit correspond to equivalent human exposures from 8 and 6 mg/kg . The aminoethoxyacetic acid metabolite (PNU-142300) is less abundant. HDPE bottles with a polypropylene screw cap containing 2 g silica gel desiccant with 100 tablets (for hospital use only).Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QDTo bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in. occurred at a median of 195 days after the last dose, and the Mortality rates were similar in patients with infections caused purely by Gram positive organisms (odds ratio 0.96; 95% confidence interval: 0.58-1.59) but were significantly higher (p=0.0162) in the linezolid arm in patients with any other pathogen or no pathogen at baseline (odds ratio 2.48; 95% confidence interval: 1.38-4.46). compassionate use program.

4.3 Contraindications.

In such circumstances, no dose adjustment is required as linezolid has an oral bioavailability of approximately 100%.The following recommendations for duration of therapy reflect those used in the clinical trials. Continue typing to refine. (See section 5.1 for the appropriate organisms).Linezolid is not active against infections caused by Gram negative pathogens.

effective treatments. As necessary, expert advice should be sought when local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. However, these effects did not reverse in juvenile animals treated with linezolid for nearly the entire period of sexual maturation. Therefore, linezolid is not recommended for use in these circumstances unless close observation and monitoring of the recipient is possible (see sections 4.3 and 4.4).In normotensive healthy volunteers, linezolid enhanced the increases in blood pressure caused by pseudoephedrine and phenylpropanolamine hydrochloride.

For streptococci (including Non-species related MIC breakpoints are Susceptible ≤ 2 mg/L and Resistant> 4 mg/L. When antibiotic-resistant organisms are encountered in the hospital it is important to emphasize infection control policies.In an open study, the efficacy of linezolid (10 mg/kg q8h) was compared to vancomycin (10- 15mg/kg q6- 24h) in treating infections due to suspected or proven resistant gram-positive pathogens(including nosocomial pneumonia, complicated skin and skin structure infections, catheter related bacteraemia, bacteraemia of unknown source, and other infections), in children from birth to 11 years. Subscription will auto renew annually.Facility for Anti-infective Drug Development and

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