In severeinfectionsdosa the sensitivitytestsareknown. treated withcefotaximeforinjection. treated You incaseyoudevelopanotherinfection, bowel), shouldbekeptunderobservation particularlycolitis(infectionofthelower whileyouarebeing Take specialcarewithcefotaximeforinjectionif: toyou, oftheaboveapplies If any youshouldnotbegivenCefotaximeforInjection. othercephalosporin. ou areallergictocefotaximeorany • • Cefotaxime forinjectionshouldnotbegivenif: surgicaloperations. infectionsfollowing prevent andtreat bones (osteomyelitis), theheartvalves(endocartitis), themembranescoveringbrain(meningitis)andliningofabdomen(peritonitis), andto ofarangeseriousbacterialinfectionsincludingCefotaxime forinjectionisusedthetreatment infectionsofthebloodstream(septicaemia), Cefotaxime belongstoagroupofmedicinescalledcephalosporinswhichareantibiotics. causeinfections. These medicinesworkbykillingbacteriathat 5. 4. itisusedfor t cefotaximeforinjectionisandwhat 3. 2. 1. In thisleaflet: for injection. The nameofyourmedicineiscefotaxime500mg, forsolutioninjectionorinfusion. 1gor 2gpowder Intherestofthisleafletitiscalledcefotaxime - - - - Read allofthisleafletcarefullybeforeyoustarttotakemedicine. should behalvedwithout change inthefrequency ordosing, i.e. 1gtwelvehourlybecomes 751miocromol/litre). approximately creatinine After aninitialloadingdose of1g, dailydose ofcefotaximeinsevererenalfailure(G=FR<5ml/min=serum to reducethedosage Dosa In severeinfections150-200mg/kg/day, individeddoses, beengiven. have Neonates: is50mg/kg/dayintwotofourdivideddoses. Therecommendeddosage infection dosesofupto200mg/kg/daymayberequired. rangis100-150mg/kg/daymayberequired.The usualdosage However, severe invery Children: than6gwillusuallyberequired. greater divided doses. For infectionscausedbysensitivePseudomonas speciesdailydosesof Your isbestforyou. doctorwilldecidethedosethat Ifyoudonotunderstand, doubt, orareinany askyourdoctorornurse. Higher dosesmaybegiven, particularlyinsevereinfections. weight intwoorfourdivideddoses. onetofourweeksis50mgperkgbody The usualdoseforinfantsaged weightdailyintwotofourdivideddoses. onemonthtotwelveyearsis100-150mgperkgbody The usualdoseforchildrenaged Children with severekidneyproblems. twelvehours.The usualadult(including injectionis1gevery dosesmaybegiventopatients theelderly)dosebyintramuscularorintravenous Lower Adults andtheElderly infants under30months, whoareallergictoLidocaineinjectionBP, ortopatients heartblock(withoutapacemaker), orwhohave orheartfailure. Cefotaxime whichhasbeendissolvedinasolutioncontainsLidocaineinjectionBP, (alocalanaesthetic), shouldnotbegivenintravenously, orto intramuscularly (intoamuscle) (intoavein)eitherbyinjectionorinfusion(drip). orgivenintravenously Your inasuitablefluidforinjection. doctorornursewillprepareyourinjectionbydissolvingthecefotaximepowder Themixtureisusuallyinjected Cefotaxime forinjectionmaycausedizziness. machinery. Ifyouareaffectedshouldnotdriveoroperate Driving andusingmachines You ifyouarepregnantorwishtobecomebreast-feedingbeforethismedicineisadministered. shouldletyourdoctorornurseknow Pregnancy andbreast-feeding 2g vialofsodiumperdose. To onacontrolledsodiumdiet. bypatients betakenintoconsideration Cefotaxime forinjectioncontains1.045mmol(or24mg)the500mgvial, 2.09mmol(or48mg)forthe1gvialand4.18mmol96mg) Important informationaboutsomeoftheingredientscefotaximeforinjection doubtsaboutwhetheryoushouldbegiventhismedicine, any If youhave thentalktoyourdoctor. • • • • othermedication): (orany ofthefollowing Please checkwithyourdoctorifyouaretakingany toldyourdoctororpharmacistandaskedtheiradvice.have This includes boughtyourselfwithoutaprescription. medicinesyoumayhave othermedicinesyouaretaking. what withcefotaximeforinjectionunlessyou knows othermedicineswhile youarebeingtreated Donottakeany Taking itortheothermedicineworks. othermedicineswhencefotaximeforinjectionisbeingadministeredcanaffecthow yourdoctor Makesurethat Taking othermedicines • • • • • ve previouslyhadanallergicreactiontopenicillinorotherantibioticsofthistype. Notallpeoplewhoareallergictopenicillinsalso • • • 6. organisms andconditionofthepatient. beforetheresultsof maybeinitiated Therapy maybevariedaccordingtotheseverityofinfection,dosage sensitivityofcausative infectionsis1g12hourly. formildtomoderate The recommendeddosage However, Adults: of thepatient. beforethe resultsofsensitivitytestsareknown. maybeinitiated Therapy determined bytheseverityofinfection, organismsandcondition thesensitivityofcausative intramuscular injection. The dosage, routeandfrequency shouldbe ofadministration Cefotaxime maybeadministeredintravenously, bybolusinjectionorinfusion, orby • ofProductCharacteristicsforfurtherinformation Please refertotheSummary Dosage andAdministrationInformationOnly

2. 1. 3.

you aretakingaminoglycosidessuchasstreptomycinandgentamicin. Y Y Further informa Ho P Ho Before youaregivencefotaximeforinjection Wha If an This medicinehasbeenprescribedforyou. If youha Keep thisleaflet. Probenecid, Furosemide orotherstrongdiuretics, Aminoglycoside antibioticssuchasstreptomycin, P You andcontactyourdoctor. immediately muststoptreatment you developasevereskinreactionsuchasStevens-Johnsonsyndrome. you arediabetic, you aregoingtoha you arebeingtrea you areonalo you ha to cephalosporins. previouslyhadanallergicreactiontosuchdrugs. Beforeyouaregiventhismedicineyour doctorshouldcheckwhetheryouhave you ha P

ou have previously had a severe allergic reaction to penicillin or any otherbeta-lactamantibiotic previouslyhadasevereallergicreactiontopenicillinorany ou have ge inrenalimpairment: Becauseofextra-renalelimination, itisonlynecessary osology andmethodofadministration osology ossible sideeffects enicillin antibioticssuchasmezlocillinandazlocillin BEFORE Y WHA HOW CEFO w cefotaximeforinjectionshouldbegiven w tostorecefotaximeforinjection y ofthesideeffectsgetserious, sideeffectsnotlistedinthisleaflet, orifyounoticeany pleasetellyourdoctororpharmacist. ve kidneyproblems. You willbecarefullymonitored throughoutyourtreatment. T CEFOTAXIME FORINJECTIONISANDWHAT ITISUSEDFOR ve any furtherquestions,ve any pleaseaskyourdoctorornurse. usedtopreventgout OU AREGIVENCEFOTAXIME FORINJECTION TAXIME FORINJECTIONSHOULDBEGIVEN w saltdiet, yourdoctorshouldmakesureyouarenotreceiving toomuchsaltbywayofcefotaximeinjections tion youmaygetfalsepositiveresultswithurineglucosetests, suchasClinitest. You whileyouarereceivingyourtreatment. mayneedtoreaditagain ge maybeincreasedupto12gdailygiveninthreeorfour ted forlongerthan10days, yourdoctorshouldmonitor yourbloodwithcounts ve a blood transfusion, make sure that the doctor who organises your transfusion knows that you are having cefotaximeforinjection ve abloodtransfusion, youarehaving that thedoctorwhoorganisesyourtransfusionknows makesurethat used to get rid of excess water fromthebody usedtogetridofexcesswater Cefotaxime 500mg powder forsolutioninjectionorinfusion Cefotaxime 500mgpowder Donotpassitontoothers. Itmayharmthem, eveniftheirsymptomsarethesameasyours. Cefotaxime 2g powder forsolutioninjectionorinfusion Cefotaxime 2gpowder forsolutioninjectionorinfusion Cefotaxime 1gpowder PACKAGE LEAFLET: INFORMATION FORTHEUSER Cefotaxime 500mg powder forsolutioninjectionorinfusion Cefotaxime 500mgpowder Cefotaxime 2g powder forsolutioninjectionorinfusion Cefotaxime 2gpowder forsolutioninjectionorinfusion Cefotaxime 1gpowder neomycinorgentamicin Information forHealthCareProfessionals

Your kidneyfunctionwillbecarefullymonitored. Symptomsmayinclude arash, blisteringoftheskin, whealsoritching. listed below inthesection entitled listed below ‘Instructions foruse/handling’. Cefotaxime shouldnotbe mixedwithothermedicinalproductsexceptthose sites. they shouldbeadministeredinseparate Cefotaxime shouldnotbeadmixedwithaminoglycosides. Iftheyareusedconcurrently injectionorsolutionscontainingaminophylline. bicarbonate Cefotaxime sodiumshouldnotbemixedwithalkaline solutionssuchassodium • perfusion fluid. Cefotaxime andaminoglycosidesshouldnotbemixed inthesamesyringeor administra intravenous whoreceived rapid fewpatients arrhythmia hasbeenreportedinvery 3 to5minutes. Duringpost-marketingsurveillance, potentiallylife-threatening For intermittent I.V. injections, thesolutionmust beinjectedoveraperiodof use/handling’. The preparedinfusionmaybeadministeredover20-60minutes. inthesectionentitled below infusionusingthefluidsstated intravenous ‘Instructionsfor Intra the syringe. theentirecontentsofvialinto Shake welluntildissolvedandthenwithdraw inthesectionentitled Injections PhEurasdiscussedbelow ‘Instructions foruse/handling’. andIntramuscular Intravenous Reconstitutecefotaximewith Administration: Water for impairment: inhepatic Dosage adjustmentisrequired. Nodosage to thecourseofinfectionandgeneralconditionpatient. eight hourlyetc. As inallotherpatients, mayrequirefurtheradjustmentaccording dosage 0.5g twelvehourly, 1geighthourlybecomes0.5ghourly, 2geighthourlybecome1g

Incompatibilities venous administration (InjectionorInfusion):venous administration Cefotaximemaybeadministeredby tion ofcefotaximethroughacentralvenouscatheter.

106641/4

Measure bar should be 150mm at 100% scale

Customer Wockhardt UK Limited Colours Used

Description Cefotaxime common leaflet Process Black Keyline (non-printing) Item Code 106641/4 Profile n-a [email protected] Clearly mark any amendments on one proof and return toSize MPS 170 x 320mm Min. Point Size 7pt (Main Body) / 7pt (Variables) Market UK Language English Proof By Warning! We cannot accept responsibility for any errors matt.pirie-scott in this proof after approval. Whilst we take extreme care Proof No. 4 at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. Date 03/03/2017 IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING Artwork No. FULL APPROVAL OF DESIGN AND TEXT. Pharma 831926 Code n-a Dilution Table: IntravenousAdministration achangeinpotencyof thefreshlypreparedsolutionsdonotindicate orsafety. andintramuscularinjection.suitable forintravenous Variations intheintensityofcolour When dissolvedin Water forinjectionsPhEur, solution cefotaximeformsastraw-coloured F • 2-8°C, asepticconditions. unlessreconstitutionhastakenplaceincontrolledandvalidated to usearetheresponsibilityofuserandwouldnormallynotbelongerthan24hoursat be usedimmediately. Ifnotusedimmediately, timesandconditionsprior in-usestorage 2-8°C.for 24hoursat From amicrobiologicalpointofview, onceopened, theproductshould For the reconstitutedsolution, chemicalandphysicalin-usestabilityhasbeendemonstrated Unopened: • *Water forinjectionor1%lidocaine Dilution Table: IntramuscularAdministration * Water forinjection By reporting side effects you can help provide more information onthesafetyofthismedicine. By reportingsideeffectsyoucanhelpprovidemoreinformation E-mail: [email protected] Website: www.hpra.ie Fax: +35316762517 Tel: +35316764971 IRL -Dublin2 Earlsfort Terrace HPRA Pharmacovigilance Ireland www.mhra.gov.uk/yellowcard Yellow CardScheme United Kingdom reportingsystemslistedbelow.side effectsdirectlyviathenational sideeffects,If yougetany talktoyourdoctor, pharmacistornurse. This includes possiblesideeffectsnotlistedinthisleaflet. any You canalsoreport Reporting ofsideeffects • • • • • • • • These include: ifyouareunwell. your doctorornurseimmediately pharmacist ornearesthospital. Your doctorwilldecidewhichdoseisbestforyou. Ifyouthinktoomuchorlittlemedicinehasbeengiventocontactyourdoctor, nurse, If youthinkhavebeengiventoomuchorlittlecefotaximeforinjection This leafletwaslastrevisedin03/2017 Manufacturer: CPPharmaceuticalsLtd, Ash RoadNorth, Wrexham, LL139UF, UK. Marketing Holder:Authorisation Wockhardt UKLtd, Ash RoadNorth, Wrexham, LL139UF, UK. Marketing AuthorisationHolderandManufacturer information: togivethefollowing Please beready 0800 1985000(UKonly) To listentoorrequestacopyoftheleafletinBraille, largeprintoraudiopleasecall, freeofcharge: X-PIL information and 50vials. powder,Cefotaxime forinjectionisanoffwhitetopaleyellow whichmustbemadeintoasolutionbeforeinjection. inpacksof1, Itisavailable 10, 25 What cefotaximeforinjectionlookslikeandcontentsofthepack 24mg(1.045mmol),The sodiumcontentpervialisapproximately 48mg(2.09mmol)and96mg(4.18mmol)respectively. Cefotaxime forinjectioncontainstheactiveingredientcefotaximeassodium. Eachvialcontains500mg, 1gor2gofcefotaxime. What cefotaximeforinjectioncontains These measureswillhelptoprotecttheenvironment. orhouseholdwaste.Medicines shouldnotbedisposedofviawastewater todisposeofmedicinesnolongerrequired.Ask yourpharmacisthow • • • • • Keep thismedicineoutofthesightandreachchildren. • Like man This is a service provided by the Royal National InstituteofBlindPeople. National providedbytheRoyal This isaservice or singleuseonly. unusedcontents. Discardany Vial size Vial size

0m 2ml 500mg 2ml 500mg 5. 4. 6.

Instructions foruse/handling Shelf lifeandspecialprecautionsforstorage Occasionally loperamide. diarrhoea, abdominalcrampsorpain, nausea, dehydration, feverorbloody, diarrhoea. anti-diarrhoeamedicines, watery Donottakeany suchas Antibiotic trea Administra Occasionally movements andconvulsions. T Other sideeffectstha The injectionsitemaybesore. F anallergicreactiontocefotaxime. ifyouthinkarehaving immediately Allergic reactionssuchasrash, Do notusecefotaximeforinjectionifthesolutioncontainspartic F 2-8°C,would normallynotbelongerthan24hoursat asepticconditions. unlessreconstitutionhastakenplaceincontrolledandvalidated product shouldbeusedimmediately. Ifnotusedimmediately, timesandconditionspriortousearetheresponsibilityofuser in-usestorage Chemical andphysicalin-usestabilityhasbeendemonstra Keep thevialinoutercartonordertoprotectfromlight. The vialsshouldnotbestoredabove25°C. This medicineshouldnotbeusedaftertheexpir in liverfunction, oftheliver, inflammation kidneyproblems, jaundice, painfuljointsandthrush. andmouthulcersoratendencyanaemia orotherchangesintheblood(whichcancausesorethroat tobleedorbruiseeasily), changes temporary g10ml 4ml 2g 1g 10ml 4ml 2g 1g

FURTHER INFORMATION reatment withhighdosesofcefotaxime,reatment withkidneyproblems, particularlyinpatients tocauselossofconsciousness, hasbeenknown abnormal eeling sick, beingsick, stomachpainanddiarrhoea, particularlywhenitisfirstgiven. or singleuseonly. Oncereconstituted, unusedportionofsolutionshouldbediscarded. any HOW TOSTORECEFO POSSIBLE SIDEEFFECTS Cefotaxime 500mg powder forsolutioninjectionorinfusion Cefotaxime 500mgpowder 2years. Donotstoreaboue25°C. Keepthevialsinoutercarton. Cefotaxime 2g powder forsolutioninjectionorinfusion Cefotaxime 2gpowder forsolutioninjectionorinfusion Cefotaxime 1gpowder Diluent* tobeadded Diluent* tobeadded y medicines, cefotaximeforinjectionmaycausesideeffects insomepatients, isfirststarted. particularlywhentreatment You shouldinform tion of high doses in patients withkidneyproblemsmaycausebraindisease. tion ofhighdosesinpatients , if you have had an intravenous injection there may be swelling around the area of infection or inflammation ofthevein. , aroundtheareaof infectionorinflammation injectiontheremaybeswelling hadanintravenous ifyouhave , sufferedabloodclot have cefotaxime. patients inaveinorirregular heartrhythmafterintravenous tment canaffectthenormalbacteriaingut, causing newinfection(colitis). You ifyoudevelop shouldtellyourdoctorimmediately Product nameReferencenumber t some patients have hadwithcefotaximeforinjection, have t somepatients particularlyifgivenoverlongperiods, include headaches, dizziness, Approx available volume Approx displacementvolume Approx volume available Approx displacementvolume Approx volume available Approx TAXIME FORINJECTION itching, feverand, rarely, very peelingskin, ofthefaceand difficultybreathing. swelling Tell yourdoctor 11.4ml 11.4ml 2.3ml 2.3ml 4.6ml 4.6ml y date (EXP) shown onthevialandcarton. (EXP)shown y date month. referstothelastdayofthat date The expiry 0.3ml 0.3ml 1.4ml 0.6ml 1.4ml 0.6ml ted for 24 hours at 2-8°C.ted for24hoursat From amicrobiologicalpointofview, onceopened, the les oriscloudy injection orinfusion. The informationinthisleafletappliesonlyto Cefotaxime Powder forsolution This leafletwaslastrevisedin03/2017 conditionsareobserved, changein potencystorage thisdoesnotindicate orsafety. of preparedsolutionsmayoccuronstorage. However, providedtherecommended maintain potency (2º-8ºC)forupto 24hours. whenrefrigerated Someincreaseincolour withmetronidazoleinfusion(500mg/100ml)andbothwill Cefotaxime iscompatible be used. freshlypreparedsolutionsshould with1%lidocaine;however Cefotaxime iscompatible unusedsolutionshouldbediscarded. After 24hoursany 1-2g cefotaximearedissolvedin40-100mlofinfusionfluid. Infusion: Intravenous InfusionBP(Ringer-lactate Intravenous Compound SodiumLactate solutionforinjection) InfusionBP Sodium ChlorideandGlucoseIntravenous InfusionBP 5% GlucoseIntravenous InfusionBP Sodium ChlorideIntravenous Water forInjectionPhEur inthefollowing: 24 hoursrefrigerated potency forupto infusionfluidsandwillretainsatisfactory commonly usedintravenous andintramuscularinjection,both intravenous withseveral cefotaxime iscompatible Reconstituted solution: Whilst itispreferabletouseonlyfreshlypreparedsolutionsfor 106641/4 PL 29831/0029 PL 29831/0030 PL 29831/0030

Measure bar should be 150mm at 100% scale

Customer Wockhardt UK Limited Colours Used

Description Cefotaxime common leaflet Process Black Keyline (non-printing) Item Code 106641/4 Profile n-a [email protected] Clearly mark any amendments on one proof and return toSize MPS 170 x 320mm Min. Point Size 7pt (Main Body) / 7pt (Variables) Market UK Language English Proof By Warning! We cannot accept responsibility for any errors matt.pirie-scott in this proof after approval. Whilst we take extreme care Proof No. 4 at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. Date 03/03/2017 IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING Artwork No. FULL APPROVAL OF DESIGN AND TEXT. Pharma 831926 Code n-a