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). 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. You may need to read it again. Swelling of the face, lips, tongue or other parts of the. or very severe infections. If you get any side effects, talk to your doctor or nurse. In the table below all adverse reactions are listed by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data). 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. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2). Your doctor will discuss this with you. varies across the European Union. To recover the cost of research and development, companies usually price their brand- name drugs on the higher side. (See table below.) 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. 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. To bookmark a medicine you must sign up and log in. Infection affecting the lungs (pneumonia). c) Each Tablet […], Cetirizine Hydrochloride & Ambroxol Hydrochloride Tablets IP 5mg/60mg Taj Pharma, Is generic medicine as safe as branded drugs? No dose adjustment of Merokem 1 gm Injection is recommended. 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. 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 %). Continue typing to refine. L'injection peut durer environ 5 minutes ou entre 15 et 30 minutes. It is not known whether Merokem 1 gm Injection alters the ability to drive. If you are allergic to meropenem or any of the other ingredients of this medicine (listed in section 6). or very severe infections. 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. Do not freeze the reconstituted solution. There is no target-based cross-resistance between meropenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes. 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 potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. If you miss a dose of Merokem 1 gm Injection, please consult your doctor. Meropenia™ 1000: Meropenem Injection IP 1000mg, Each vial contains: Meropenem IP (Sterile) equivalent to anhydrous Meropenem 1000mg, sodium carbonate IP(Sterile) equivalent to Sodium (as buffer) 90.2mg. The medicinal product is supplied in pack sizes of 1 or 10 vials. After infusion over 5 minutes Cmax values are 52 and 112 μg/ml after 500 and 1000 mg doses respectively. There have been many reports of increases in the anti-coagulant effects of orally administered anti-coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents. Renal impairment results in higher plasma AUC and longer half-life for meropenem. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). These side effects are usually temporary and go away during treatment as your body adjusts to the medicine. 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. Meropenem Injection IP 1g (Merokem) Taj Pharma. for injection or infusion. Meropenem Injection IP 1g. at the Louis Pasteurlaan 5 : 2719 EE, Zoetermeer, Netherlands . The solutions should be inspected visually for particles and discolouration prior to administration. In preclinical models meropenem demonstrated activity when plasma concentrations exceeded the MIC of the infecting organisms for approximately 40 % of the dosing interval. As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy. Merokem 1 gm Injection is probably safe to use during breastfeeding. pH of the product after reconstitution is 7.3 to 8.3. CAUTION: To be sold by retail on the prescription of Registered Medical Practitioner only. The medicinal product is supplied in pack sizes of 1 or 10 vials. The signs may include a sudden onset of: If you notice any of the above, see a doctor straight away. post-title portfolio-title Product after reconstitution is clear colourless to yellow solution. If you have a severe allergic reaction, stop having Meropenem and see a doctor straight away. Meropenem + Sulbactam is a combination of two medicines: Meropenem and Sulbactam. 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). 5 Non-species related breakpoints have been determined mainly from PK/PD data and are independent of the MIC distributions of specific species. 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 dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. 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. 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). This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. Treating physicians should refer to national and/or international consensus documents regarding the treatment of glanders and melioidosis. Meropenem injection is in a class of medications called antibiotics. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems. This medicine is generally regarded as safe to use in pregnancy and breastfeeding if prescribed by your doctor. No studies on the effect on the ability to drive and use machines have been performed. Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. 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. How should Meropenem be used: It comes as a solution for injection, administered by a healthcare provider, into the vein. MEROPENEM RANBAXY vials contain either 500mg or 1g of meropenem (as meropenem trihydrate) as the active ingredient. The hospital staff make it up into a solution before injection. 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. 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. 4.2 Posology and method of administration. Animal studies indicate that meropenem is well tolerated by the kidney. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. Glanders and melioidosis: Use of meropenem in humans is based on in vitro B.mallei and. Meropenem Injection IP stockiest and super stockiest (distributor) in the field of tablets, syrup, otc, antibiotics, life saving and critical care products. This target has not been established clinically. We have a well-equipped Quality Control (QC) laboratory, which ensures that our products are pure, safe and effective and are released only after thorough analysis as per stringent procedures. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. Severe hypersensitivity (e.g. To develop these block buster drugs they take a minimum of 10 years. 6.6 Special precautions for disposal and other handling. Dose adjustment of Merokem 1 gm Injection may be needed. 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. The maximum daily dose of this product is equivalent to ≥27% of the WHO recommended maximum daily intake for sodium. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. Meropenem is a white to pale yellow crystalline powder for solution for injection or infusion in vial. 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. 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 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. To email a medicine you must sign up and log in. You should have your injections at the same time each day to get the most benefit and you should keep on taking this medicine for as long as you are prescribed it, even if your symptoms quickly improve. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Product after reconstitution is clear colourless to yellow solution. A White to pale yellow crystalline powder. Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. For use in one patient on one occasion only. Children from 3 months to 11 years of age and up to 50 kg body weight. Your doctor or nurse will normally give Meropenem to, However, some patients, parents and carers are trained to give Meropenem at home. 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). Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 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. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01DH02. 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. 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. A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses. It should be used with caution in patients with central nervous system disorders. This is usually accompanied with a loss of consciousness. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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. 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. Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 –75 %) of the dose is excreted unchanged within 12 hours. Meropenem injection ip 1g, stockiest and super stockiest (distributor) in the field of tablets, syrup, otc, antibiotics, life saving and critical care products. A dose is usually given every 8 hours. 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. And this generic medicines are all WHO certified so there’s no chance of low quality generic medicines. Do not freeze the reconstituted solution. In this case, the prepared solution if stored under refrigeration (i.e. 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). The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed: 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. When multiple doses are administered 8-hourly to subjects with normal renal function, accumulation of meropenem does not occur. 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). For intravenous infusion meropenem vial may be directly constituted with 0.9% sodium chloride or 5% glucose (dextrose) solutions for infusion. Common side effects of Meropenem : 4.7 Effects on ability to drive and use machines. 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. Hence given the high cost of clinical trials and R&D these branded drugs tend to be priced heavily for the firms to recover the money spent and also to earn windfall profits ( Patent life is only for 20 years for these drugs ). anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. Meropenem Injection Ip 1G offered by TAPADIYA OVERSEAS is available with multiple payment options and easy delivery. 250 mg . What Meropenem looks like and contents of the pack. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. Date of first authorisation/renewal of the authorisation. Meropenem … within 30 minutes following reconstitution. 2-8°C) should be used within 1 hour after it has left the refrigerator. 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. Product Description. anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. European Committee on Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for MIC testing are presented below. 6 The beta-lactam susceptibility of streptococcus groups A, B, C and G is inferred from the penicillin susceptibility. 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. The following table of pathogens listed is derived from clinical experience and therapeutic guidelines. A White to pale yellow crystalline powder. We have a highly skilled team of regulatory affairs specialists who are well versed with regulatory policies and procedures around the world. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism. Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD. Alternatively, meropenem doses of up to 20 mg/kg may be given ... Injection Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection. 2 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately, i.e. 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). Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving meropenem. 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 %). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. The solution should be shaken before use. The intravenous formulation was well tolerated in animal studies. 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. Meropenem is licensed for children over 3 months of age. Meropenem is considered high in sodium. DBL Meropenem for Injection is presented as a sterile white powder containing meropenem trihydrate equivalent to meropenem, 500 mg or 1 g, blended with anhydrous sodium carbonate. Tärkeää tietoa Meropenem Hospiran sisältämistä aineista Meropenem Hospira sisältää natriumia. Intravenous bolus injection administration. Upset stomach, headache, nausea, vomiting, constipation, or diarrhea may also occur. It is used to treat severe infections of the skin, lungs, stomach, urinary tract, blood and brain (eg. Always use this medicine exactly as your doctor or nurse has told you. Merokem 1 gm Injection is an antibiotic that fights bacteria. Intravenous bolus injection administration. 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 Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported. Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. IV- The recommended dose is 0.5 gm to 2 gm (10 to 40mgkg) by slow infusion, 3 times per day. Changes in blood tests, including tests that show how well your kidneys are working. Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6). EUCAST clinical MIC breakpoints for meropenem (2015-01-01, v5). There was no evidence of increased sensitivity to meropenem in juveniles compared to adult animals. The symptoms include frequent infections, high temperature and sore throat. Merolan(meropenem) is an antibiotic that fights bacteria. Therefore, your doctor will decide whether you should use meropenem while breast-feeding. No dose adjustment is necessary in patients with hepatic impairment (see section 4.4). A solution for bolus injection is prepared by dissolving the drug product meropenem in sterile water for injection to a final concentration of 50 mg/ml. Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meropenem to yourself or someone else at home’). Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. a) Each vial contains: Meropenem Trihydrate equivalent to Meropenem 125mg Excipients q.s. They are for use only for organisms that do not have specific breakpoints. Medicinal products that inhibit peristalsis should not be given. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). 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. Increased numbers of platelets in your blood (shown in a blood test). Consideration should be given to official guidance on the appropriate use of antibacterial agents. Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. transaminases increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased. 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). The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. Severe pneumonia, including hospital and ventilator-associated pneumonia. varies across the European Union. A further 28% is recovered as the microbiologically inactive metabolite. The tables below provide general recommendations for dosing. 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. Check with your doctor or nurse if you are not sure. 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. Powder for solution for injection or infusion. Merokem 1 gm Injection is safe to use in patients with liver disease. 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. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. No dose adjustment is required in elderly patients, except in cases of moderate to severe renal impairment (see section 4.2). The maximum daily dose of this product is equivalent to ≥27% of the WHO recommended maximum daily intake for sodium. Meropenem is used to treat the following in adults and children aged 3 months and older: Infection affecting the lungs (pneumonia), Lung and bronchial infections in patients suffering from cystic fibrosis, Complicated urinary tract infections, Complicated infections in the abdomen, Infections that you can catch during or after the delivery, Complicated skin and soft tissues infections, Acute bacterial infection of the brain (meningitis). Cheers. This medicine has been prescribed for you Do not pass it on to others. A further 28% is recovered as the microbiologically inactive metabolite. In individuals with normal renal function, rapid renal elimination will occur. 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). Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately, i.e. A solution for bolus injection is prepared by dissolving the drug product meropenem in sterile water for injection to a final concentration of 50 mg/ml. Each ml of reconstituted solution contains 50 mg Meropenem. Interaction studies have only been performed in adults. Until there is evidence regarding clinical response for confirmed isolates with MIC values above the current resistant breakpoint they should be reported resistant. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. † Resistance rate≥ 50% in one or more EU countries. The IV LD50 of meropenem in rodents is greater than 2000 mg/kg. Mechanism of Action: Meropenem is a carbapenem antibiotic for parenteral use, that is stable to human dehydropeptidase-I (DHP-I). The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6 %) and increased hepatic enzymes (1.5-4.3 %). Meropenem should not be used because it may decrease the effect of sodium. Qualitative and quantitative composition a) Each vial of powder for solution for injection or infusion contains 570.78 mg meropenem trihydrate equivalent to 500mg anhydrous meropenem. The maximum recommended daily dose of this medicinal product contains 540 mg sodium (found in table salt). Powder for solution for injection or infusion : Intravenous use . Swelling, redness, pain, or soreness at the injection site may occur. Do not take a double dose (two injections at the same time) to make up for a forgotten dose. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). Your doctor will tell you how to give, You should normally have your injections at the same times each. In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs. Ceftriaxone Injection IP. The required dose should be administered after completion of the haemodialysis cycle. Small amounts of this medicine may pass into the breast milk. In repeat dose studies of up to 6 months duration only minor effects were seen including a decrease in red cell parameters in dogs. Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. Direct antiglobulin test (Coombs test) seroconversion. The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. Your doctor may do blood tests from time to. 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). Find dosages, compare prices and get up to 20% off on prescription medicines. A positive direct or indirect Coombs test may develop during treatment with meropenem. Ask your pharmacist how to throw away medicines you no longer use. Meropenem concentrations in the CSF of children with meningitis are approximately 20 % of concurrent plasma levels although there is significant inter- individual variability. MEROPENEM RANBAXY is a sterile white to pale yellow powder supplied in a glass vial. 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).
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