Product Name: High Quality L-Carnitine Injection 500mg/5ml, 5's/Box Slimming & Beauty Weight Loss Model NO.: WT-016 Pharmaceutical Technology: Chemical Synthesis Type: Organic Chemicals Shape: Liquid State: Liquid Suitable for: Elderly, Adult Usage Mode: I.V Application: Internal Medicine Other Specification: 1g, 2g, 3G Trademark: OEM Transport Package: 5ampoules/Box Specification: 500MG/5ML Origin: China HS Code: 2923900090 Product Description LEVOCARNITINE INJECTIonPRODUCT NAME:L-carnitine Liquid for InjectionSTRENGTH:0.5/ 1.0/ 2.0/ 3.0gPACKING DETAILS:5Ampoules/tray/boxSTORAGE:Store in a cool and dry place below 25ºC, protected from light.SHELF LIFE:36 monthsREGISTRATION DOSSIERS ARE AVAILABLE.Composition :The active ingredient is levocarnitine. Each 5ml contains 500 mg levocarnitine.Pharmaceutical Action :Levocarnitine is a naturally occurring substance required substance required inMammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entryenergy production. Fatty acids are utilized as an energy substrate in all tissues except thebrain. In skeletal and cardiac muscle, fatty acids are the main substrate for energyproduction. Primary systemic carnitine deficiency is characterized by low concentrationsof levocarnitine in plasma, RBC, and or tissues. It has not been possible to determinewhich symptoms are due to carnitine deficiency and which are due to the underlyingorganic acidemia, as symptoms of both abnormality may be expected to improve withcarnitine. The literature reports that carnitine can promote the excretion of excess organicof fatty acids in patients with defects in fatty acid metabolism and/or specific organicacidopathies that bioaccumulate acyl COA esters.IndIcations :For the acute and chronic treatment of patients with an inborn error of metabolism whichresuIts in secondary carnitine deficiency.Forthepreventionandtreatmentofcarnitinedeficiencyinpatientswithendstagerenaldisease who are undergoing dialysis.Dosage and Administrations :levocarnitine Injection is administered intravenously.metabolic DIsordersThe recommended dose is 50 mg/kg given as a slow 2-3 minute bolus i njection or byinfusion. Often a loading dose is given in patients with severe metabolic crisis, followedby an equivalent dose over the following 24 hours. It should be administered q3h or q4h,and never less than q6h either by infusion or by intravenous injection. All subsequentdaily doses are recommended to be in the range of 50 mg/kg or as therapy may require.The highest dose administered has been 300 mg/kg.It is recommended that a plasma carnitine concentration be obtained prior to beginningthis parenteral therapy. Weekly and monthly monitoring is recommended as well. Thismonitoring should include blood chemistries, vital signs, plasma carnitine concentrations(the plasma free carnitine concentration should be between 35 and 60 umol/L) and overallclinical condition.ESRD Patients on HemodialysisThe recommended starting dose is 10-20 mg/kg dry body weight as a slow 2-3 minutebolus injection into the venous return line after each dialysis session. Initiation of therapymay be prompted by trough(pre-dialysis) plasma levocarnitine concentrations that arebelow normal (40-50 umol/L). Dose adjustments should be guided by trough(pre-dialysis) levocarnitine concentrations, and downward dose adjustments (e.g. to 5 mg/kg afterdialysis) may be made as early as the third or fourth week of therapy.SideEffects:Transientnauseaandvomitinghavebeenobserved.Lessfrequentadversereactionsarebodyodor,nausea,andgastritis.Anincidenceforthesereactionsisdifficulttoestimateduetotheconfoundingeffectsoftheunderlyingpathology.Seizures have been reported to occur in patients, with or without pre-existing seizureaactivity, receiving either oral or intravenous levocarnitine. In patients with pre-existingseizureactiviy,anincreaseinseizurefrequencyand/orseverityhasbeenreported.Warnings :Diabetic patients taking insulin or oral hypoglycemic drug treatment, levocarnitine cancause hypoglycemia, so plasma glucose levels in these patients mustbe constantlymonitored, in order to adjust hypoglycemic treatment. Intravenous administration shouldbe carried outslowly(2-3 minute).Because levocarnitine is a physlological property die does not show any danger in thetolerance and dependence.Keep out of reach of children.Levocarnitine has noadverse effect on the ability to drive or operate the machine.Precautions:The safety and efficacy of oral levocarnitine has not been evaluated in patients with renalinsufficiency.Chronic administration of high doses of oral levocarnitine in patients withseverely compromised renal function or in ESRD patients on dialysis may result inaccumulation of the potentially toxic metabolites, trimethylamine (TMA) andtrimethylamine-N-oxide(TMAO), since these metabolites are normally excreted in theurine.PregnancyReproductive studies have been performed in rats and rabbits at doses up to 3.8 timesthe human dose on the basis of surface area and haverevealednoevidenceofimpairedfertilityorharmtothefetusduetolevocarnitineinjection.Thereare,however,noadequateandwellcontrolledstudiesinpregnantwomenBecauseanimalreproductionstudiesarenotalwayspredictiveofhumanresponse,thisdrugshouldbeusedduringpregnancyonlyifclearlyneeded.Nursing Mothers:Levocarnitine supplementation in nursing mothers has not been specifically studied.Contraindications:Allergic to this medicine should be contraindicated.Drug Interactions:No information provided.Presentation:Each 5ml ampoule contains 500mg levocarnitine,5ampoules in one box.Storage and Instructions:Store below 30'C and protect from light.Keep out of reach of Children.