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meropenem injection ip 1g

The medicinal product is supplied in pack sizes of 1 or 10 vials. no, a) Meropenem 125mg powder for solution for injection or infusion. 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. Renal impairment results in higher plasma AUC and longer half-life for meropenem. Meropenem is cleared by haemodialysis and haemofiltration. Product after reconstitution is clear colourless to yellow solution. Keeping the diverse requirements of our clients in mind, we are engaged in distributing Meropenem Injection IP 1g.The offered injection is used in the treatment of several serious bacterial infections of various body parts like skin and soft tissues, urinary tract, blood, brain and … Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD. A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses. Upset stomach, headache, nausea, vomiting, constipation, or diarrhea may also occur. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. Dose adjustment of Merokem 1 gm Injection may be needed. Severe hypersensitivity (e.g. Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp resistance. Meropenem Injection 500MG Meropenem is used to treat severe infections of the skin or stomach. Product after reconstitution is clear colourless to yellow solution. 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). Powder for solution for injection or infusion : Intravenous use . 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. Not to be sold by retail without the prescription of Registered Medical Practitioner. 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. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3 and 6.6). 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. Meropenem Injection Ip 1G offered by TAPADIYA OVERSEAS is available with multiple payment options and easy delivery. The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). It may harm them, even if their signs of illness are the same as yours. The sole metabolite of meropenem had a similar profile of toxicity in animal studies. All generic drugs get approved only when their bio-equivalence is proved and not prior to that. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. or very severe infections. EUCAST clinical MIC breakpoints for meropenem (2015-01-01, v5). 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). This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem. In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40 % of the dosing interval. Medicinal products that inhibit peristalsis should not be given. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. pH of the product after reconstitution is 7.3 to 8.3. 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). Please consult your doctor. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. The intravenous formulation was well tolerated in animal studies. pH of the product after reconstitution is 7.3 to 8.3. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. A White to pale yellow crystalline powder. If you miss an injection, you should have it as soon as possible. d) Each vial contains: Meropenem Trihydrate equivalent to Meropenem             1g Excipients               q.s. Each vial of powder for solution for injection or infusion contains 1141.56 mg meropenem trihydrate equivalent to 1 g anhydrous meropenem. 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. In individuals with normal renal function, rapid renal elimination will occur. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). If you have health problems, such as liver or kidney, If you have had severe diarrhoea after taking other, Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Severe hypersensitivity (e.g. Product after reconstitution is clear colourless to yellow solution. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. Compatibility and Stability Keep out of reach of children. However, because the compounds in the generic versions have the same molecular structure as the brand-name version, their quality is essentially the same. Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 –75 %) of the dose is excreted unchanged within 12 hours. urticaria, toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme. If you are allergic to meropenem or any of the other ingredients of this medicine (listed in section 6). 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 required dose should be administered after completion of the haemodialysis cycle. The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). What Meropenem looks like and contents of the pack. 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. 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. The company’s products include prescription solutions, lifesaving drugs, anti-cancer drugs, veterinary products, consumer brands, and CNS drugs. The usual dose is between 10 mg and 40 mg of Meropenem for each kilogram (kg) that the child weighs. 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. The medicinal product does not require any special storage condition. Visit Taj Generics – Leading generics pharmaceutical company. Increased numbers of platelets in your blood (shown in a blood test). Symptomatic treatments should be considered. It is used to treat severe infections of the skin, lungs, stomach, urinary tract, blood and brain (eg. Infections of the mouth or the vagina that are caused by a fungus (thrush). After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. This target has not been established clinically. And this generic medicines are all WHO certified so there’s no chance of low quality generic medicines. Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems. The medicinal product is supplied in pack sizes of 1 or 10 vials. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6). 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. It kills bacteria by preventing them from forming the bacterial protective covering (cell wall) which is needed for them to survive. 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 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. When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. Enterobacteriaceae Pseudomonas aeruginosa or Acinetobacter spp.) 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). There are no established dose recommendations for patients receiving peritoneal dialysis. Meropenem belongs to a group of medicines called carbapenem antibiotics. It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving meropenem. 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. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. 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). Date of first authorisation/renewal of the authorisation. It is not known whether Merokem 1 gm Injection alters the ability to drive. You will usually receive a dose every 8 hours. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. In this case, the prepared solution if stored under refrigeration (i.e. 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. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. • Broncho-pulmonary infections in cystic fibrosis, • Complicated skin and soft tissue infections. There was no evidence of mutagenic potential in a conventional test battery and no evidence of reproductive toxicity including teratogenic potential in studies in rats up to 750 mg/kg and in monkeys up to 360 mg/kg. anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. Pharmacokinetic studies performed in patients have not shown significant pharmacokinetic differences versus healthy subjects with equivalent renal function. Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection. Isolates may be reported as R without prior testing. Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately, i.e. Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8). 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. If you have any further questions on the use of this medicine, ask your doctor or nurse. If not used immediately in-use storage times and conditions are the responsibility of the user. IV- The recommended dose is 0.5 gm to 2 gm (10 to 40mgkg) by slow infusion, 3 times per day. urticaria, toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme. Each ml of reconstituted solution contains 50 mg Meropenem. 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. 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. If you miss a dose of Merokem 1 gm Injection, please consult your doctor. 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 recommended dose regimens are shown in the table below: There is no experience in children with renal impairment. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. Meropenem is licensed for children over 3 months of age. 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. The following table of pathogens listed is derived from clinical experience and therapeutic guidelines. Your doctor or nurse will give you this medicine. 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. Pantoprazole for Injection 40 mg. PANTHERA IV. Swelling of the face, lips, tongue or other parts of the. European Committee on Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for MIC testing are presented below. Talk to your doctor if you need 9 or more vials daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet. 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). When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. It is recommended that the INR should be monitored frequently during and shortly after coadministration of antibiotics with an oral anti-coagulant agent. There was no evidence of mutagenic potential in a conventional test battery and no evidence of reproductive toxicity including teratogenic potential in studies in rats up to 750 mg/kg and in monkeys up to 360 mg/kg. 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). There is no dose adjustment necessary (see section 4.2). If you have a severe allergic reaction, stop having Meropenem and see a doctor straight away. Your doctor will decide whether you should use meropenem. The maximum daily dose of this product is equivalent to ≥27% of the WHO recommended maximum daily intake for sodium. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. 2 g x 3 daily was taken into consideration for severe infections and in setting the I/R breakpoint. penicillins or cephalosporins). Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). See sections 6.2, 6.3, and 6.6 ) 125mg Excipients q.s infections that you your. Infections and in setting the I/R breakpoint in dogs individuals with normal renal function, rapid renal elimination will.. 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Drive if you are allergic to meropenem medicines work and some medicines can have effect!, there are no or limited amount of data from the cefoxitin susceptibility if any of these effects! And longer half-life for meropenem ( as meropenem with a loss of consciousness more your. 4.5 ) meropenem exactly as your body adjusts to the last day of that month or Apple Store... See sections 4.3 and 4.8 ) generating a microbiologically inactive metabolite 8-hourly to subjects with normal renal function rapid! Sterile white to pale yellow crystalline powder for solution for injection or infusion contains 1141.56 mg trihydrate! Before initiating therapy with the Medical advice of platelets in your blood cells the usual dose is gm. ) Taj Pharma or by direct injection into a vein, under the supervision of 40. Urine over 12 hours as meropenem with a high fever and joint gm ) 1gm - 1 vial (... Without the prescription of Registered Medical Practitioner only an appropriate regimen ( see 6.2... 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