Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction. Meropenem … Lots of people don’t know the difference between generic and branded medicines and that’s where doctor’s and pharmacies take the advantage and prescribe only branded medicines to earn more commission. Your doctor may do blood tests from time to. The recommended dose regimens are shown in the table below: There is no experience in children with renal impairment. No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. Broncho-pulmonary infections in cystic fibrosis, Complicated skin and soft tissue infections, Management of febrile neutropenic patients. Direct antiglobulin test (Coombs test) seroconversion. Check with your doctor or nurse if you are not sure. Upset stomach, headache, nausea, vomiting, constipation, or diarrhea may also occur. 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. c) Each Tablet […], Cetirizine Hydrochloride & Ambroxol Hydrochloride Tablets IP 5mg/60mg Taj Pharma, Is generic medicine as safe as branded drugs? Children from 3 months to 11 years of age and up to 50 kg body weight. Concomitant use with valproic acid/sodium valproate/valpromide. Meropenem has been shown to penetrate well into several body fluids and tissues: including lung, bronchial secretions, bile, cerebrospinal fluid, gynaecological tissues, skin, fascia, muscle, and peritoneal exudates. If you get any side effects, talk to your doctor or nurse. Additional Information: Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. For use in one patient on one occasion only. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Talk to your doctor if you need 5 or more vials daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet. CORTI CAT Lyophilized 100. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. You may need urgent medical treatment. No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. Any of these side effects could affect your ability to drive or operate machines. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. IXZA® 500 is available as vial of Meropenem injection IP 500mg along with 10mL sterile water for injections IP for reconstitution. Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis. Reporting suspected adverse reactions after authorisation of the medicinal product is important. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Excipients with known effect: Each vial contains 208 mg sodium carbonate approximately 4.0 mmol of sodium (approximately 90 mg). Infusion At first generic medicines have the same amount of dosage as compared to branded medicines and the amount of content is also the same, the difference is only in size shape and taste. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2). While using it, you may be advised blood tests to monitor your blood cells and kidney function. Date of first authorisation/renewal of the authorisation. Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above after a single administration and above and in monkeys at 500 mg/kg in a 7-day study. Meropenem should be stored at room temperature, 20 C to 25 C (68 F to 77 F). 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. Monte Carlo simulation based on a population PK model showed that a dose regimen of 20 mg/kg 8 hourly achieved 60 %T>MIC for P. aeruginosa in 95 % of pre-term and 91 % of full term neonates. For the full list of excipients, see section 6.1. penicillins or cephalosporins). CAUTION: To be sold by retail on the prescription of Registered Medical Practitioner only. There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy. Meropenem is cleared by haemodialysis with clearance during haemodialysis being approximately 4 times higher than in anuric patients. 4.2 Posology and method of administration. Severe pneumonia including hospital and ventilator-associated pneumonia. Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). It is preferable to avoid the use of meropenem during pregnancy. Your doctor or nurse will give you this medicine. Severe pneumonia, including hospital and ventilator-associated pneumonia. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ingredients. Qualitative and quantitative composition a) Each vial of powder for solution for injection or infusion contains 570.78 mg meropenem trihydrate equivalent to 500mg anhydrous meropenem. See section 4. The reason so explaining above its not possible due to following explanation as said above The main difference by which you can distinguish is the price for eg, the difference between the brand-name drug and the generic could be Rs 10 (Rs 35 and Rs 25 respectively), depending on what the retailer keeps in each case, the actual difference in the price paid by a customer of a brand-name drug and that of a generic could be, perhaps, only Rs 4 (Rs 27 and Rs 23). There are no established dose recommendations for patients receiving peritoneal dialysis. The medicinal product does not require any special storage condition. Meropenem Injection 500MG Meropenem is used to treat severe infections of the skin or stomach. Always use Meropenem exactly as your doctor has told you. 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. 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.

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