meropenem injection ip 1g

Meropenem has been associated with headache; tingling or pricking skin (paraesthesia). Meropenem is licensed for children over 3 months of age. No studies on the effect on the ability to drive and use machines have been performed. No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. EUCAST clinical MIC breakpoints for meropenem (2015-01-01, v5), Haemophilus influenzae1,2 and Moraxella catarrhalis2, Gram-positive anaerobes except Clostridium difficile. Meropenem … European Committee on Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for MIC testing are presented below. Your doctor will discuss this with you. † Resistance rate≥ 50% in one or more EU countries. 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. The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. This should be particularly taken into account for those on a low salt diet. The medicinal product is supplied in pack sizes of 1 or 10 vials. Merokem 1 gm Injection is an antibiotic. There are limited data to support the administration of these dose adjustments for a unit dose of 2 g. (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above). Meropenem should not be used because it may decrease the effect of sodium. Qualitative and quantitative composition a) Each Tablet Contains: Sirolimus 0.5mg Excipients q.s. No specific medicinal product interaction studies other than probenecid were conducted. Therefore, your doctor will decide whether you should use meropenem while breast-feeding. penicillins or cephalosporins). Common side effects of Meropenem : Votre injection ne doit pas être, mélangée avec, ou ajoutée à, des solutions contenant d'autres médicaments. 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. 1349.56 mg powder in a 40ml Type-I, tubular, clear glass vial with stopper (bromobutyl rubber with aluminum seals having white colour polypropylene discs). Medicinal products that inhibit peristalsis should not be given. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The maximum recommended daily dose of this medicinal product contains 540 mg sodium (found in table salt). Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter- individual variability. Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby. In particular, tell your doctor or nurse if you are taking any of the following medicines: Oral anti-coagulant agent (used to treat or prevent blood clots). The AUC of the microbiologically inactive ring opened metabolite was also considerably increased in patients with renal impairment. Direct antiglobulin test (Coombs test) seroconversion. Not all pack sizes may be marketed. How do I distinguish between a brand name drug and a generic drug by looking at its cover? Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite. You may need urgent medical treatment. This target has not been established clinically. pH of the product after reconstitution is 7.3 to 8.3. Symptomatic treatments should be considered. Caution is required if probenecid is co-administered with meropenem. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Side Effects. Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. Interaction studies have only been performed in adults. DBL Meropenem for Injection contains 208 mg sodium carbonate anhydrous for each gram of meropenem (anhydrous potency). Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately, i.e. The AUC of the microbiologically inactive ring opened metabolite was also considerably increased in patients with renal impairment. transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased. Product after reconstitution is clear colourless to yellow solution. Meropenem will be given to you as an injection or infusion into a large vein. The dose depends on what type of infection you have, where it is in the body and how serious it is. 1g Method of administration Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). If not used immediately in-use storage times and conditions are the responsibility of the user. d) Each vial contains: Meropenem Trihydrate equivalent to Meropenem             1g Excipients               q.s. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Powder for solution for injection or infusion . a) Each vial contains: Meropenem Trihydrate equivalent to Meropenem          125mg Excipients                  q.s. MEROPENEM RANBAXY vials contain either 500mg or 1g of meropenem (as meropenem trihydrate) as the active ingredient. Intravenous powder for solution: 500 mg/vial and 1 gram/vial. 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. penicillins or cephalosporins). This medicinal product contains 90 mg sodium per dose, equivalent to 4.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter- individual variability. 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. This target has not been established clinically. -- = Susceptibility testing not recommended as the species is a poor target for therapy with the drug. It is used to treat severe infections of the skin, lungs, stomach, urinary tract, blood and brain (eg. The maximum daily dose of this product is equivalent to ≥27% of the WHO recommended maximum daily intake for sodium. The tables below provide general recommendations for dosing. They are for use only for organisms that do not have specific breakpoints. Infections of the mouth or the vagina that are caused by a fungus (thrush). Product after reconstitution is clear colourless to yellow solution. Meropenem Injection IP 500mg (Merokem) Taj Pharma Meropenem Injection IP 1g (Merokem) Taj Pharma. Upset stomach, headache, nausea, vomiting, constipation, or diarrhea may also occur. • Keep this leaflet. By continuing to browse the site you are agreeing to our policy on the use of cookies. Other possible side effects: Uncommon (may affect up to 1 in 100 people), Rare (may affect up to 1 in 1,000 people), Frequency not known (cannot be estimated from available data). It is recommended that the INR should be monitored frequently during and shortly after coadministration of antibiotics with an oral anti-coagulant agent. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). European Committee on Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for MIC testing are presented below. MERO PALM. Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. Meropenem is generally well tolerated by the central nervous system. This medicinal product contains 90 mg sodium per dose, equivalent to 4.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult. TRAIX. Meropenem is considered high in sodium. The medicinal product does not require any special storage condition. Meropenem is cleared by haemodialysis with clearance during haemodialysis being approximately 4 times higher than in anuric patients. Tutkimuksia Meropenem Hospiran vaikutuksesta ajokykyyn tai kykyyn käyttää koneita ei ole tehty. Any of these side effects could affect your ability to drive or operate machines. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. Standard aseptic techniques should be used for solution preparation and administration. Intravenous bolus injection administration. 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. If you have any further questions on the use of this medicine, ask your doctor or nurse. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 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. Do not stop having Meropenem until your doctor tells you to. Infection affecting the lungs (pneumonia). For intravenous infusion meropenem vial may be directly constituted with 0.9% sodium chloride or 5% glucose (dextrose) solutions for infusion. This should be particularly taken into account for those on a low salt diet. EUCAST clinical MIC breakpoints for meropenem (2015-01-01, v5). No dose adjustment is necessary in patients with hepatic impairment (see section 4.4). 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. 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. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. Check with your doctor or nurse if you are not sure. Changes in your blood. Small amounts of meropenem have been reported to be excreted in human milk. Do not freeze the reconstituted solution. Broncho-pulmonary infections in cystic fibrosis, Complicated skin and soft tissue infections, Management of febrile neutropenic patients. In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs. Merokem 1 gm Injection is generally considered safe to use during pregnancy. 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. Continue, 2. Pharmacokinetic studies in healthy elderly subjects (65-80 years) have shown a reduction in plasma clearance, which correlated with age-associated reduction in creatinine clearance, and a smaller reduction in non-renal clearance. within 30 minutes following reconstitution. pH of the product after reconstitution is 7.3 to 8.3. CORTI CAT Lyophilized 100. The tables below provide general recommendations for dosing. Infections that you can catch during or after the. However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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. 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. If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meropenem. When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. 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 or nurse will give you this medicine. 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). Some people may develop side effects like nausea, vomiting, diarrhea, rash or local redness and swelling at the site of injection. If you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems as you may also be allergic to meropenem. It allows continued monitoring of the benefit/risk balance of the medicinal product. Information about drug Meropenem includes cost of the drug and the type of drug - tablet, capsule, syrup, cream, gel, ointment, liquid or injection. Haemodialysis will remove meropenem and its metabolite. Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection. However, it will not treat a viral infection. If not used immediately in-use storage times and conditions are the responsibility of the user. No studies on the effect on the ability to drive and use machines have been performed. Infusion at the Louis Pasteurlaan 5 : 2719 EE, Zoetermeer, Netherlands . No specific medicinal product interaction studies other than probenecid were conducted. Find substitute medicine(s) for generic MEROPENEM 1GM at Netmeds.com. The mean meropenem clearance values were 5.8 ml/min/kg (6-12 years), 6.2 ml/min/kg (2- 5 years), 5.3 ml/min/kg (6-23 months) and 4.3 ml/min/kg (2-5 months). Meropenem is cleared by haemodialysis with clearance during haemodialysis being approximately 4 times higher than in anuric patients. If you get any side effects, talk to your doctor or nurse. 2-8°C) should be used within 1 hour after it has left the refrigerator. 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): • Severe pneumonia, including hospital and ventilator-associated pneumonia. Other changes in your blood. Do not freeze the reconstituted solution. 24*7 network in all area of gujarat. 1g/30 ml . Merokem 1 gm Injection is safe to use in patients with liver disease. 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. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as infections due to less susceptible bacterial species (e.g. Children from 3 months to 11 years of age and up to 50 kg body weight. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite. varies across the European Union. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. Buy low price Meropenem Injection Ip 1G in Sadashiv Peth, Pune. 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. 2-8°C) should be used within 1 hour after it has left the refrigerator. Paediatric populationThe pharmacokinetics in infants and children with infection at doses of 10, 20 and 40 mg/kg showed Cmax values approximating to those in adults following 500, 1000 and 2000 mg doses, respectively. No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. 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. Each ml of reconstituted solution contains 50 mg Meropenem. 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). Meropenem Injection IP stockiest and super stockiest (distributor) in the field of tablets, syrup, otc, antibiotics, life saving and critical care products. A further 28% is recovered as the microbiologically inactive metabolite. Meropenem is cleared by haemodialysis and haemofiltration. Meropenem may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above. BiotransformationMeropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite. This is usually accompanied with a loss of consciousness. transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased. Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Tärkeää tietoa Meropenem Hospiran sisältämistä aineista Meropenem Hospira sisältää natriumia. Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. In individuals with normal renal function, rapid renal elimination will occur. 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). The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). Renal impairment results in higher plasma AUC and longer half-life for meropenem. After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. Generic medicines are same as branded medicines, even the company that makes branded medicines manufacturers generic version but with a lower price. The solutions should be inspected visually for particles and discolouration prior to administration. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6). Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 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. Isolates may be reported as R without prior testing. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. Severe pneumonia, including hospital and ventilator-associated pneumonia. 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. 3 Susceptibility of staphylococci to carbapenems is inferred from the cefoxitin susceptibility. © 2020 Copyright by Taj Pharma India | Taj Pharma Group  All rights reserved. There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. This site uses cookies. This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. If not used immediately in-use storage times and conditions are the responsibility of the user. Additional Information: Meropenem 500 MG Injection is a broad spectrum antibiotic used to treat a variety of conditions caused by bacteria such as infections of stomach, brain, and lungs. Until there is evidence regarding clinical response for confirmed isolates with MIC values above the current resistant breakpoint they should be reported resistant. 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. Since the only cost that is incurred by them is the cost of manufacturing and supplying , generic drugs tend to be priced 80% lower than the latter. Enterobacteriaceae Pseudomonas aeruginosa or Acinetobacter spp.) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. These side effects are usually temporary and go away during treatment as your body adjusts to the medicine. The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. Innovative drug companies spend around $1 Billion for bringing new innovative drugs to the market. Meropenem Powder For Injection IP 1g (Merokem) Taj Pharma Overview INTRODUCTION OF MEROKEM POWDER FOR INJECTION Merokem 1 gm Injection is an antibiotic that fights bacteria. Severe hypersensitivity (e.g. 4.7 Effects on ability to drive and use machines. There is no dose adjustment necessary (see section 4.2). 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 1gm IV injection (vial) Brand name : Merolan (or) Merowin - Mylan Lab Strength : 1gm in vial. Merokem 1 gm Injection is probably safe to use during breastfeeding. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. c) Each vial contains: Meropenem Trihydrate equivalent to Meropenem          500mg Excipients                  q.s. The required dose should be administered after completion of the haemodialysis cycle. 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. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. The other ingredient is sodium carbonate. Faecal elimination represents only approximately 2% of the dose. Like all medicines, this medicine can cause side effects, although not everybody gets them. Product Description. It is recommended that the INR should be monitored frequently during and shortly after coadministration of antibiotics with an oral anti-coagulant agent. Since the manufacture of these generic drugs do not involve a repeat of the extensive clinical trials to prove their safety and efficacy, it costs less to develop them. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see section 4.8). In this case, the prepared solution if stored under refrigeration (i.e. Mechanism of Action: Meropenem is a carbapenem antibiotic for parenteral use, that is stable to human dehydropeptidase-I (DHP-I). It allows continued monitoring of the benefit/risk balance of the medicinal product. The symptoms include frequent infections, high temperature and sore throat. urticaria, toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme. Before starting treatment with this medicine, you should tell your doctor if you have epilepsy, liver or kidney problems or if you are allergic to any antibiotic. While using it, you may be advised blood tests to monitor your blood cells and kidney function. or very severe infections. Changes in blood tests, including tests that show how well your liver is working. Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01DH02. This medicine is generally regarded as safe to use in pregnancy and breastfeeding if prescribed by your doctor. The maximum daily dose of this product is equivalent to ≥27% of the WHO recommended maximum daily intake for sodium. Meropenem is considered high in sodium. Do not drive if you experience any symptoms that affect your ability to concentrate and react. For the full list of excipients, see section 6.1. Start typing to retrieve search suggestions. There are no established dose recommendations for patients receiving peritoneal dialysis. 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. 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. The average plasma protein binding of meropenem was approximately 2 % and was independent of concentration. Sirolimus Tablets 2mg (Sirlotaj) Taj Pharma  Name of the medicinal product a) Sirolimus Tablets 0.5mg (Sirlotaj) Taj Pharma b) Sirolimus Tablets 1mg (Sirlotaj) Taj Pharma c) Sirolimus Tablets 2mg (Sirlotaj) Taj Pharma 2. There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals.

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