There are no established dose recommendations for patients receiving peritoneal dialysis. Meropenem 1gm IV injection (vial) Brand name : Merolan (or) Merowin - Mylan Lab Strength : 1gm in vial. CORTI CAT Lyophilized 100. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. Medicinal products that inhibit peristalsis should not be given. Do not freeze the reconstituted solution. Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite. Netherlands : AstraZeneca BV . pH of the product after reconstitution is 7.3 to 8.3. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. 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. Severe pneumonia, including hospital and ventilator-associated pneumonia. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. no, a) Meropenem 125mg powder for solution for injection or infusion. No studies on the effect on the ability to drive and use machines have been performed. penicillins or cephalosporins). Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. Each vial of powder for solution for injection or infusion contains 1141.56 mg meropenem trihydrate equivalent to 1 g anhydrous meropenem. Powder for solution for injection or infusion. Bacterial resistance to meropenem may result from: (1) decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins) (2) reduced affinity of the target PBPs (3) increased expression of efflux pump components, and (4) production of beta-lactamases that can hydrolyse carbapenems. Some people may develop side effects like nausea, vomiting, diarrhea, rash or local redness and swelling at the site of injection. All generic drugs get approved only when their bio-equivalence is proved and not prior to that. In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3 %), rash (1.4 %), nausea/vomiting (1.4 %) and injection site inflammation (1.1 %). The selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria. Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Pantoprazole for Injection 40 mg. PANTHERA IV. Similar to other beta-lactam antibacterial agents, the time that meropenem concentrations exceed the MIC (T>MIC) has been shown to best correlate with efficacy. Severe pneumonia including hospital and ventilator-associated pneumonia. Swelling, redness, pain, or soreness at the injection site may occur. Symptomatic treatments should be considered. Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter- individual variability. Standard aseptic techniques should be used for solution preparation and administration. Hypersensitivity to any other carbapenem antibacterial agent. Your doctor will discuss this with you. Meropenem belongs to a group of medicines called carbapenem antibiotics. Direct antiglobulin test (Coombs test) seroconversion. Serious hypersensitivity reactions involving fever, skin rash, and changes in the blood tests that check how the liver is working (increased levels of liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. 3 hours when stored at controlled room temperature (15-25°C); 8 hours when stored under refrigerated conditions (2-8°C); Do not freeze the reconstituted. Comparison showed consistent pharmacokinetics between the doses and half-lives similar to those observed in adults in all but the youngest subjects (<6 months t1/2 1.6 hours). Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). The IV LD50 of meropenem in rodents is greater than 2000 mg/kg. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40 % of the dosing interval. Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter- individual variability. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. These side effects are usually temporary and go away during treatment as your body adjusts to the medicine. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. All reports received were consistent with events observed in the adult population. The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response. Animal studies indicate that meropenem is well tolerated by the kidney. The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. This is equivalent to 27% of the adult recommended maximum daily dietary intake for sodium. d) Each vial contains: Meropenem Trihydrate equivalent to Meropenem 1g Excipients q.s. The AUC of the microbiologically inactive ring opened metabolite was also considerably increased in patients with renal impairment. Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti- bacterial agents, including meropenem, and may range in severity from mild to life threatening. Meropenem has been associated with headache; tingling or pricking skin (paraesthesia). The following table of pathogens listed is derived from clinical experience and therapeutic guidelines. Merokem 1 gm Injection is generally considered safe to use during pregnancy. Meropenem 500mg / 1g Vials by UNITED BIOTECH (P) LTD, Manufacturer, Supplier, Exporter of Meropenem Injection IP 500mg / 1g Vials, Meropenem Injection etc. If not used immediately in-use storage times and conditions are the responsibility of the user. There were AUC increases of 2.4 fold in patients with moderate impairment (CrCL 33-74 ml/min), 5 fold in severe impairment (CrCL 4-23 ml/min) and 10 fold in haemodialysis patients (CrCL <2 ml/min) when compared to healthy subjects (CrCL >80 ml/min). Direct antiglobulin test (Coombs test) seroconversion. Meropenem may also be used for purposes not listed in this medication guide. There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals. Generic medicines are same as branded medicines, even the company that makes branded medicines manufacturers generic version but with a lower price. There is no dose adjustment necessary (see section 4.2). However, bacteria may exhibit resistance to more than one class of antibacterials agents when the mechanism involved include impermeability and/or an efflux pump(s). Tutkimuksia Meropenem Hospiran vaikutuksesta ajokykyyn tai kykyyn käyttää koneita ei ole tehty. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2). 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. AMITRY 100. The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response. Meropenem for Injection injection vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem) may be stored for up to 2 hours at controlled room temperature 15-25°C (59-77°F) or for up to 12 hours at 4°C (39°F). When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. The solutions should be inspected visually for particles and discolouration prior to administration. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated upto 3 hours at controlled room temperature (15-25°C) or upto 8 hours under refrigerated conditions (2-8°C). Each ml of reconstituted solution contains 50 mg Meropenem. Due to the rapid onset and the extent of the decrease, co-administration of valproic acid/sodium valproate/valpromide with carbapenem agents is not considered to be manageable and therefore should be avoided (see section 4.4). No specific medicinal product interaction studies other than probenecid were conducted. The most important part is that India is the manufacturing hub of generic medicines and India alone accounts for 90% of the total exports all over the world. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. While using it, you may be advised blood tests to monitor your blood cells and kidney function. It is preferable to avoid the use of meropenem during pregnancy. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. Pharmacokinetic studies performed in patients have not shown significant pharmacokinetic differences versus healthy subjects with equivalent renal function. 1 Meropenem breakpoints for Streptococcus pneumoniae and Haemophilus influenzae in meningitis are 0.25 mg/l (Susceptible) and 1 mg/l (Resistant). Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meropenem to yourself or someone else at home’). Meropenem Injection IP stockiest and super stockiest (distributor) in the field of tablets, syrup, otc, antibiotics, life saving and critical care products. Non species related breakpoints are based on the following dosages: EUCAST breakpoints apply to meropenem 1000 mg x 3 daily administered intravenously over 30 minutes as the lowest dose. As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy. Upset stomach, headache, nausea, vomiting, constipation, or diarrhea may also occur. MEROPENEM RANBAXY vials contain either 500mg or 1g of meropenem (as meropenem trihydrate) as the active ingredient. Infections of the mouth or the vagina that are caused by a fungus (thrush). This includes any possible side effects not listed in this leaflet. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Meropenem is indicated for the treatment of the following infections in adults and children aged 3 months and older (see sections 4.4 and 5.1): Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Product after reconstitution is clear colourless to yellow solution. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6). TRAIX. To recover the cost of research and development, companies usually price their brand- name drugs on the higher side. And this generic medicines are all WHO certified so there’s no chance of low quality generic medicines. 1g/30 ml . 3 Susceptibility of staphylococci to carbapenems is inferred from the cefoxitin susceptibility. Let me elucidate in a nut-shell as to why the price difference occurs in the first place. A White to pale yellow crystalline powder. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome. How do I distinguish between a brand name drug and a generic drug by looking at its cover? Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated upto 3 hours at controlled room temperature (15-25°C) or upto 8 hours under refrigerated conditions (2-8°C). Do not freeze the reconstituted solution. What Meropenem is and what it is used for, What you need to know before you take Meropenem, Contents of the pack and other information. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). Other changes in your blood. Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately, i.e. This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. Consult your doctor if these side effects bother you or do not go away. The tables below provide general recommendations for dosing. BiotransformationMeropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite. 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. penicillins or cephalosporins). No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. The other ingredient is sodium carbonate. 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). The required dose should be administered after completion of the haemodialysis cycle. pH of the product after reconstitution is 7.3 to 8.3. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory. Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days. 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. Check with your doctor or nurse if you are not sure. 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. You should check with your doctor if you are not, Your injection should not be mixed with or added to solutions that contain other, The injection may take about 5 minutes or between 15 and 30 minutes. The pharmacokinetics of meropenem in neonates requiring anti-infective treatment showed greater clearance in neonates with higher chronological or gestational age with an overall average half-life of 2.9 hours. Meropenem Injection IP 1g Mero 1g full explain with this medicine...?? Meropenem is used to treat the following in adults and children aged 3 months and older: Meropenem may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above. Haemodialysis will remove meropenem and its metabolite. In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3 %), rash (1.4 %), nausea/vomiting (1.4 %) and injection site inflammation (1.1 %). Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. 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 injection ip 1g, stockiest and super stockiest (distributor) in the field of tablets, syrup, otc, antibiotics, life saving and critical care products. Meropenem Injection IP 1g. 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. 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. a) Meropenem 125mg powder for solution for injection or infusion b) Meropenem 250mg powder for solution for injection or infusion c) Meropenem 500mg powder for solution for injection or infusion d) Meropenem 1g powder for solution for injection or infusion. Votre médecin vous dira comment MEROPENEM MYLAN 1 g, poudre pour … Do not drive if you experience any symptoms that affect your ability to concentrate and react. If you have any further questions on the use of this medicine, ask your doctor or nurse. As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy. Each vial of powder for solution for injection or infusion contains 1141.56 mg meropenem trihydrate equivalent to 1 g anhydrous meropenem. The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory. After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. TRAIX-SB. 250 mg . The time interval between the beginning of reconstitution and the end of intravenous injection should not exceed: After reconstitution: The reconstituted solutions for intravenous infusion should be used immediately. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. It works by killing bacteria, which can cause serious infections. Animal studies indicate that meropenem is well tolerated by the kidney. Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Concomitant use with valproic acid/sodium valproate/valpromide. Only clear colourless to yellow solution, free from particles should be used. 6.6 Special precautions for disposal and other handling. 6 hours when stored at controlled room temperature (15-25°C) when meropenem is dissolved in sodium chloride; 12 hours when stored at 2-8°C when meropenem is dissolved in sodium chloride. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. Children from 3 months to 11 years of age and up to 50 kg body weight. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. Staphylococcus aureus (methicillin-susceptible)£, Staphylococcus species (methicillin-susceptible) including Staphylococcus epidermidis, Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermedius), Peptostreptococcus species (including P. micros, P anaerobius, P. magnus), Species for which acquired resistance may be a problem, $ Species that show natural intermediate susceptibility, £ All methicillin-resistant staphylococci are resistant to meropenem. Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp resistance. Product after reconstitution is clear colourless to yellow solution. How should Meropenem be used: It comes as a solution for injection, administered by a healthcare provider, into the vein. If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away. However, because the compounds in the generic versions have the same molecular structure as the brand-name version, their quality is essentially the same. within 30 minutes following reconstitution. Small amounts of meropenem have been reported to be excreted in human milk. Only clear colourless to yellow solution, free from particles should be used. The AUC of the microbiologically inactive ring opened metabolite was also considerably increased in patients with renal impairment. 2-8°C) should be used within 1 hour after it has left the refrigerator. If not used immediately in-use storage times and conditions are the responsibility of the user. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Find dosages, compare prices and get up to 20% off on prescription medicines. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. If you miss a dose of Merokem 1 gm Injection, please consult your doctor. Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. Antibiotic Injection We are a leading Manufacturer of meropenem injection ip, 2.25 g piperacillin tazobactam injection, 1g meropenem injection ip, piperacillin tazobactam injection usp, 4.5 gm piperacillin tazobactam injection and cefoperazone sulbactam injection from Mumbai, India. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome), blood creatinine increased, blood urea increased, General disorders and administration site conditions, Thrombophlebitis, pain at the injection site, Injection site reactions (pain, swelling, redness). However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem. The pharmacokinetics of meropenem in neonates requiring anti-infective treatment showed greater clearance in neonates with higher chronological or gestational age with an overall average half-life of 2.9 hours. GMP certified pharmaceutical company fully geared for exports, We are technology driven company supported by extensive F&D department; coupled with well-equipped laboratories and best talented technical officials of the industry. 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).