Meropenem 1 g powder for solution for injection or infusion Summary of Product Characteristics SmPC emc
The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalized ratio) is difficult to assess. It is recommended that the INR should be monitored frequently during and shortly after coadministration of antibiotics with an oral anti-coagulant agent. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes.
- The exploration of antibacterial therapies other than antibiotics has attracted more and more attention.
- Photothermal therapy (PTT) has become a promising antibacterial method due to its low invasiveness, low toxicity and avoidance of drug-resistant bacteria.
- There are no or limited amount of data from the use of meropenem in pregnant women.
- When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur.
- In healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ml/min at 2 g.
Many reports have confirmed that a combination of other antibacterial methods with PTT could effectively reduce the side effects on normal cells and enhance the therapeutic effect. In view of the rapid development of synergistic PTT in antibacterial therapy, this review mainly discusses and summarizes the advancements of several synergistic photothermal antibacterial methods within the last five years. The remaining challenges and future opportunities in this field are also highlighted. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. Pharmacokinetic studies performed in patients have not shown significant pharmacokinetic differences versus healthy subjects with equivalent renal function. A population model developed from data in 79 patients with intra-abdominal infection or pneumonia, showed a dependence of the central volume on weight and the clearance on creatinine clearance and age.
Meropenem 1 g powder for solution for injection or infusion
Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8). If a severe allergic reaction https://vetyversports.fr/secure-steroid-purchases-uk-buyers-benefit-from/ occurs, the medicinal product should be discontinued and appropriate measures taken. The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below.
Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8). Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. For instructions on reconstitution of the medicinal product before administration, see section 6.6.
If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered. Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. There have been many reports of increases in the anti-coagulant effects of orally administered anti-coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents.
- The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below.
- For instructions on reconstitution of the medicinal product before administration, see section 6.6.
- Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2.
- However, when PTT is used alone, it requires a higher temperature to achieve a better antibacterial effect, which will not only kill bacteria, but also cause damage to normal tissues, and even trigger new inflammation.
In recent years, infection caused by drug-resistant bacteria has become a serious public health problem. The exploration of antibacterial therapies other than antibiotics has attracted more and more attention. Photothermal therapy (PTT) has become a promising antibacterial method due to its low invasiveness, low toxicity and avoidance of drug-resistant bacteria. However, when PTT is used alone, it requires a higher temperature to achieve a better antibacterial effect, which will not only kill bacteria, but also cause damage to normal tissues, and even trigger new inflammation.
Meropenem 1 g powder for solution for injection or infusion
In vitro meropenem shows reduced susceptibility to hydrolysis by human dehydropeptidase-I (DHP-I) compared to imipenem and there is no requirement to co-administer a DHP-I inhibitor. 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. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
There are no established dose recommendations for patients receiving peritoneal dialysis. Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. For intravenous infusion meropenem vial may be directly constituted with 0.9% sodium chloride or 5% glucose (dextrose) solutions for infusion. Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately, i.e. within 30 minutes following reconstitution. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. The sole metabolite of meropenem had a similar profile of toxicity in animal studies.
A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses. A study of 12 patients administered meropenem 1000 mg 8 hourly post-surgically for intra-abdominal infections showed a comparable Cmax and half-life to normal subjects but a greater volume of distribution 27 l. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated up to 3 hours at controlled room temperature (15-25°C) or up to 8 hours under refrigerated conditions (2-8°C). From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Meropenem is a white to pale yellow crystalline powder for solution for injection or infusion in vial. No dose adjustment is necessary in patients with hepatic impairment (see section 4.4). The required dose should be administered after completion of the haemodialysis cycle.