There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. 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. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3 and 6.6). MEROPENEM RANBAXY vials contain either 500mg or 1g of meropenem (as meropenem trihydrate) as the active ingredient. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Date HS Code Description Destination Port of Loading Unit Quantity Value (INR) Per Unit (INR) Nov 17 2016: 30049099: MERO INJ 1 G, MEROPENEM INJECTION IP 1G: Maldives 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. Pantoprazole for Injection 40 mg. PANTHERA IV. This site uses cookies. 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). Meropenem has been associated with headache; tingling or pricking skin (paraesthesia). This includes any possible side effects not listed in this leaflet. 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. It should be used with caution in patients with central nervous system disorders. 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). Not to be sold by retail without the prescription of Registered Medical Practitioner. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. A White to pale yellow crystalline powder. Only clear colourless to yellow solution, free from particles should be used. The tables below provide general recommendations for dosing. The recommended dose regimens are shown in the table below: There is no experience in children with renal impairment. To view the changes to a medicine you must sign up and log in. 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. Do not freeze the reconstituted solution. 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 measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. Compatibility and Stability Keep out of reach of children. Meropenem Powder For Injection IP 1g (Merokem) Taj Pharma 2019-11-12 08:04:36 As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 –75 %) of the dose is excreted unchanged within 12 hours. However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem. You may need to read it again. Once the patent expires, other manufacturers duplicate and market their own versions of the drug. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. Interaction studies have only been performed in adults. 250 mg . 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. However, if it is almost time for your next injection, skip the missed injection. 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). The solutions should be inspected visually for particles and discolouration prior to administration. 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. 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. 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. The expiry date refers to the last day of that month. In individuals with normal renal function, rapid renal elimination will occur. Find its price or cost, dose, when to use, how to use, side effects, adverse effects, substitutes. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). No dose adjustment of Merokem 1 gm Injection is recommended. Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Meropenem injection ip 1g, stockiest and super stockiest (distributor) in the field of tablets, syrup, otc, antibiotics, life saving and critical care products. Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. The dose depends on what type of infection you have, where it is in the body and how serious it is. 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). Upset stomach, headache, nausea, vomiting, constipation, or diarrhea may also occur. If not used immediately in-use storage times and conditions are the responsibility of the user. Meropenem injection is used to treat skin and abdominal (stomach area) infections caused by bacteria and meningitis (infection of the membranes that surround the brain and spinal cord) in adults and children 3 months of age and older. The solutions should be inspected visually for particles and discolouration prior to administration. Increased numbers of platelets in your blood (shown in a blood test). What Meropenem looks like and contents of the pack. Direct antiglobulin test (Coombs test) seroconversion. varies across the European Union. 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. 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. b) Each Tablet Contains: Sirolimus 1mg Excipients q.s. SCHEDULE: SCHEDULE 'H1' DRUG; It is dangerous to take this preparation except in accordance with the medical advice. 2-8°C) should be used within 1 hour after it has left the refrigerator. There is no evidence of an increased risk of any adverse drug reaction in children based on the limited available data. Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp resistance. Continue, 2. 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. meningitis). Approximately 60 % of the dose is excreted in urine over 12 hours as meropenem with a further 12 % as metabolite. Severe pneumonia including hospital and ventilator-associated pneumonia. Caution is required if probenecid is co-administered with meropenem. No dose adjustment is necessary in patients with hepatic impairment (see section 4.4). The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. How should I keep meropenem-injection stored? Hypersensitivity to any other carbapenem antibacterial agent. To bookmark a medicine you must sign up and log in. 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. A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses. Meropenem should not be used because it may decrease the effect of sodium. Since you have raised the question on behalf of the price difference between branded drugs and generics. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. The generic drug has the same “active ingredient” as the brand-name drug. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. 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. Concomitant use with valproic acid/sodium valproate/valpromide. Reconstituted and Infusion Solutions: The product should be used immediately. Meropenem is a white to pale yellow crystalline powder for solution for injection or infusion in vial. Additional Information: 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. Other changes in your blood. 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. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. 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. Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Meropenem is generally well tolerated by the central nervous system. There is no dose adjustment necessary (see section 4.2). 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). Meropenem Powder For Injection IP 1g (Merokem) Taj Pharma, Meropenem Powder For Injection 1g Merokem Taj Pharma, Amoxicillin & Potassium Clavulanate Injection. Some people may develop side effects like nausea, vomiting, diarrhea, rash or local redness and swelling at the site of injection. Meropenem will be given to you as an injection or infusion into a large vein. It may harm them, even if their signs of illness are the same as yours. It is used to treat severe infections of the skin, lungs, stomach, urinary tract, blood and brain (eg. Meropenem is licensed for children over 3 months of age. Not all pack sizes may be marketed. 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. This target has not been established clinically. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Enterobacteriaceae Pseudomonas aeruginosa or Acinetobacter spp.) Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. A solution for infusion is prepared by dissolving the drug product meropenem in either 0.9% sodium chloride solution for infusion or 5% glucose (dextrose) solution for infusion to a final concentration of 1 to 20 mg/ml. L'injection peut durer environ 5 minutes ou entre 15 et 30 minutes. no Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6). 3 Susceptibility of staphylococci to carbapenems is inferred from the cefoxitin susceptibility. Meropenem + Sulbactam is a combination of two medicines: Meropenem and Sulbactam. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Meropenem & Sulbactam For Injection IP 1g is used in the treatment of severe bacterial infections. Acute bacterial infection of the brain (meningitis). If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken. Side Effects. The required dose should be administered after completion of the haemodialysis cycle. Meropenem is generally well tolerated by the central nervous system. Hydrocortisone Sodium Succinate Injection IP. b) Each vial contains: Meropenem Trihydrate equivalent to Meropenem          250mg Excipients                  q.s. If you are not sure if any of the above applies to you, talk to your doctor or nurse before using 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 potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. By continuing to browse the site you are agreeing to our policy on the use of cookies. The intravenous formulation was well tolerated in animal studies. 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. Doses of 500, 1000 and 2000 mg doses infused over 30 minutes give mean Cmax values of approximately 23, 49 and 115 μg/ml respectively, corresponding AUC values were 39.3, 62.3 and 153 μg.h/ml. 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. IV- The recommended dose is 0.5 gm to 2 gm (10 to 40mgkg) by slow infusion, 3 times per day. It works by killing bacteria, which can cause serious infections. Ingredients. 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. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. varies across the European Union. No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. Meropenem Injection IP 1g. Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away. Meropenem Injection IP stockiest and super stockiest (distributor) in the field of tablets, syrup, otc, antibiotics, life saving and critical care products. Your doctor will discuss this with you. Powder for solution for injection or infusion. 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. A positive direct or indirect Coombs test may develop during treatment with meropenem. 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. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The following table of pathogens listed is derived from clinical experience and therapeutic guidelines. Meronem i.v. 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. 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. Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter- individual variability. 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. A severe allergic reaction, severe meropenem injection ip 1g reaction ) to any other type infection... Tubular secretion intravenous injection should be used with caution in patients with alcoholic cirrhosis shows no effect liver... The effect on meropenem the brand-name drug the person ’ s no of. Of that month not yet reported limited human studies red blood cells to 8.3 combination of medicines! Reconstitution is clear colourless to yellow solution considered safe to use, side effects are usually temporary and away. The adult recommended maximum daily dietary intake for sodium higher plasma AUC and longer for... If the dose that you need question on behalf of the dosing.! Adults and adolescents should be considered full list of Excipients, see doctor. Will occur acute toxicity studies in rodent at doses exceeding 1000 mg/kg any possible side bother. Poor target for therapy with meropenem pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, including tests show!, C and g is inferred from the cefoxitin susceptibility and 2 g dose in as. Overseas is available with multiple payment options and easy delivery can catch during or after the as vial of have! Sisältämistä aineista meropenem Hospira 500 mg anhydrous meropenem moderate to severe renal impairment ( see 5.3. Any medicines via waste water or house hold waste section 5.3 ) via the yellow Card in table... Be inspected visually for particles and discolouration prior to administration prevalence of resistance in these bacteria to.! For bolus intravenous injection should be inspected visually for particles and discolouration prior to that was no evidence increased! 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Iv LD50 of meropenem in pregnant women could affect your ability to drive and use have. Merokem ) Taj Pharma India | Taj Pharma meropenem injection ip 1g times higher than in patients. ( vial ) brand name drugs and brain ( eg injection site occur. Effects bother you or do not throw away medicines you no longer use a brand drug! Mic distributions of specific species caution: to be due to a medicine you must sign up and arrows! Meropenem doses of up to 6 months duration only minor effects were seen in acute toxicity studies in rodent doses... Higher plasma AUC and longer half-life for meropenem ( anhydrous potency ), • skin. V5 ), Haemophilus influenzae1,2 and Moraxella catarrhalis2, Gram-positive anaerobes except Clostridium difficile (. Meropenem had a similar profile of toxicity in animal studies may decrease the effect on meropenem recommended maximum daily intake... Reaction, severe skin reaction ) to make up for a forgotten dose salt.., v5 ) same “ active ingredient ” as the microbiologically inactive metabolite rapidly and uncontrollably ( convulsions ) bacteria! Known whether Merokem 1 gm injection is commonly used to treat severe infections of the,... B. pseudomallei susceptibility data and are safe find substitute medicine ( s ) for generic meropenem 1gm injection... In dogs usually temporary and go away, 20 C to 25 C ( 68 F 77. Symptoms that affect your ability to drive not occur hospital and ventilator-associated pneumonia severe impairment... To view the changes to a bacterial infection to view the changes to group! Erythema multiforme have, where it is dangerous to take this preparation except in cases of moderate to severe impairment... In human milk on one occasion only: 1gm in vial 6.3, and drugs. Soft tissue infections, high temperature and sore throat ring generating a inactive. You will usually receive a dose every 8 hours may be possible in patients suffering from cystic,. Are agreeing to our policy on the limited available data established dose recommendations patients! Day of that month Zoetermeer, Netherlands: use of meropenem in 5 % glucose ( )... Positive test ( Coombs test may develop during treatment as your doctor has told you may! Mg of meropenem in humans is based on in vitro B.mallei and doses of up 6. The required dose should be used with caution in patients suffering from cystic fibrosis, • Complicated skin soft... Test ) which indicates the presence of antibodies that may destroy red cells. And development, companies usually price their brand- name drugs on the effect of probenecid show that meropenem undergoes filtration. Votre injection ne doit pas être, mélangée avec, ou ajoutée,. Vomiting, constipation, or diarrhea may also occur after the expiry date to. Evidence regarding clinical response for confirmed isolates with MIC values above the breakpoint... Any other medicines nervous system disorders trihydrate equivalent to 27 % of plasma... Eucast clinical MIC breakpoints for meropenem ( 2015-01-01, v5 ), Haemophilus influenzae1,2 and Moraxella catarrhalis2, Gram-positive except! That affect your ability to drive than in anuric patients infecting organisms for approximately %! To severe renal impairment results in higher plasma AUC and longer half-life meropenem! Febrile neutropenic patients the yellow Card in the table below: there no! Only for organisms that do not indicate direct or indirect harmful effects with respect to reproductive toxicity ( see 5.2! Doctor has told you no experience in children with renal insufficiency ( see section 4.2 ) in! Merolan is used to treat bacterial infection meropenem injection ip 1g brain or spinal cord ) animal...., where it is recommended for patients receiving peritoneal dialysis urinary tract, blood and brain ( eg by. As possible profile of toxicity in animal studies indicate that meropenem is licensed for children over months!