FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Danish: Behandling af patienter med bakteriæmi, som opstår i forbindelse med eller mistænkes for at være associeret med en eller flere af de ovenfor nævnte infektioner.
English: • Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
Danish: • Alvorlige hudreaktioner (Stevens-Johnson syndrom og erythema multiforme)
English: Stenotrophomonas maltophilia (formerly Xanthomonas maltophilia, formerly Pseudomonas maltophilia)
Danish: Stenotrophomonas maltophilia (tidligere Xanthomonas maltophilia, tidligere Pseudomonas maltophilia)
English: • Tremors and uncontrolled twitching of muscles
Danish: • Rysten og ukontrollerede ryk i muskler
English: dose in mg (interval hrs)
Danish: dosis i mg (interval i timer)
English: Species resistant to other carbapenems do generally express co-resistance to imipenem.
Danish: Arter, som er resistente over for andre carbapenemer, udviser generelt co-resistens over for imipenem.
English: These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.
Danish: Risikoen for, at disse reaktioner opstår, er større hos personer, som tidligere har udvist overfølsomhed over for multiple allergener.
English: Distribution The binding of cilastatin to human serum proteins is approximately 40%.
Danish: Fordeling Cilastatins binding til humant serumprotein er ca. 40%.
English: In exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons, 5% glucose may be used instead.
Danish: Hvis 0,9% natriumchlorid af kliniske grunde ikke kan anvendes, kan 5% glucose undtagelsesvist anvendes i stedet for.
English: 3: Inferred from cefoxitin susceptibility
Danish: 3: Udledt fra cefoxitins følsomhed
English: If the use of TIENAM is deemed necessary, the benefit of breast feeding for the child should be weighed against the possible risk for the child.
Danish: Hvis anvendelse af TIENAM er nødvendig, bør fordelen ved amning for barnet opvejes mod den mulige risiko for barnet.
English: Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with imipenem/cilastatin.
Danish: Anvendelse til patienter med leversygdom: Hos patienter med eksisterende leverproblemer bør leverfunktionen monitoreres under behandling med imipenem/cilastatin.
English: • Local pain and formation of a firm lump at the injection site
Danish: • Lokal smerte og dannelse af en fast knude på injektionsstedet
English: Common diarrhoea, vomiting, nausea Medicinal product-related nausea and/or vomiting appear to occur more frequently in granulocytopenic patients than in nongranulocytopenic patients treated with TIENAM
Danish: Diarré, opkastning, kvalme Lægemiddelrelateret kvalme og/eller opkastning synes at forekomme oftere hos patienter med granulocytopeni end hos patienter, der ikke har granulocytopeni
English: There are no data available regarding potential effects of imipenem/cilastatin treatment on male or female fertility.
Danish: Der er ingen data vedrørende den potentielle virkning af behandling med imipenem/cilastatin på mænds eller kvinders fertilitet.
English: Repeat with an additional 10 ml of infusion solution to ensure complete transfer of vial contents to the infusion solution.
Danish: Gentag med yderligere 10 ml infusionsvæske for at sikre fuldstændig overførsel af hætteglassets indhold til infusionsvæsken.
English: At these doses, plasma levels of imipenem decline to below 1 μg/ml or less in four to six hours.
Danish: Ved disse doser faldt imipenems plasmakoncentration til under 1 g/ml i løbet af 4-6 timer.
English: The mean plasma half-lives of imipenem and cilastatin were 91 ± 7.0 minutes and 69 ± 15 minutes, respectively.
Danish: Den gennemsnitlige plasmahalveringstid for imipenem og cilastatin var henholdsvis 91 ± 7,0 minutter og 69 ± 15 minutter.
English: Approximately 70% of the administered antibiotic was recovered intact in the urine within ten hours, and no further urinary excretion of imipenem was detectable.
Danish: Ca. 70 % af det indgivne antibiotikum blev genfundet uomdannet i urinen inden for 10 timer, og ingen yderligere urinudskillelse af imipenem kunne påvises.
English: Renal impairment To determine the reduced dose for adults with impaired renal function:
Danish: Nedsat nyrefunktion For at fastsætte en reduceret dosis til voksne med nedsat nyrefunktion:
English: Medicinal products that inhibit peristalsis should not be given.
Danish: Lægemidler, som hæmmer peristaltikken, bør ikke gives.
English: The selection of imipenem/cilastatin 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.
Danish: Valg af imipenem/cilastatin til behandling af en patient skal træffes under hensyntagen til det hensigtsmæssige i at anvende et carbapenem-antibiotikum baseret på faktorer som infektionens sværhedsgrad, hyppigheden af resistens over for andre egnede antibiotika samt risikoen for selektion af carbapenem-resistente bakterier.
English: The dose recommendations for TIENAM represent the quantity of imipenem/cilastatin to be administered.
Danish: Doseringsanbefalingerne for TIENAM angiver den mængde af imipenem/cilastatin, der skal administreres.
English: Austria: Zienam
Danish: Østrig: Zienam
English: • Swelling and redness along a vein which is extremely tender when touched
Danish: • Hævelse og rødme langs en vene, der er ekstrem øm ved berøring
English: Rare acute renal failure, oligurial/anuria, polyuria, urine discoloration (harmless and should not be confused with haematuria) The role of TIENAM in changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present.
Danish: Akut nyresvigt, oliguri/anuri, polyuri, farveændring af urinen (harmløst og må ikke forveksles med hæmaturi) TIENAMs rolle i ændringer i nyrefunktionen er vanskelig at vurdere, da faktorer, som prædisponerer til præ-renal azotemi eller nedsat nyrefunktion, ofte er til stede
English: • Changes in the amounts of blood cells
Danish: • Ændring i antallet af blodceller
English: If an allergic reaction to TIENAM occurs, discontinue the therapy immediately.
Danish: Hvis der opstår en allergisk reaktion over for TIENAM, skal behandlingen seponeres omgående.
English: Haematology A positive direct or indirect Coombs test may develop during treatment with imipenem/cilastatin.
Danish: Hæmatologi En positiv direkte eller indirekte Coombs test kan forekomme under behandling med imipenem/cilastatin.
English: 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.
Danish: Ekspertrådgivning bør søges efter behov, når prævalensen af resistens lokalt er af en sådan beskaffenhed, at anvendelse af midlet er tvivlsom for nogle typer infektion.
English: The average clearance (CL) and volume of distribution (Vdss) for imipenem were approximately 45% higher in paediatric patients (3 months to 14 years) as compared to adults.
Danish: Den gennemsnitlige clearance og fordelingsvolumenet for imipenem var ca. 45% højere hos pædiatriske patienter (3 måneder til 14 år) end hos voksne.
English: Studies in pregnant monkeys have shown reproductive toxicity (see section 5.3).
Danish: Undersøgelser hos gravide aber har vist reproduktionstoksicitet (se pkt.
English: Approximately 10% was found as the Nacetyl metabolite, which has inhibitory activity against dehydropeptidase comparable to that of cilastatin.
Danish: Ca. 10% blev fundet som N-acetyl-metabolitten, som har en hæmmende virkning på dehydropeptidase, der er sammenlignelig med cilastatins.
English: • Worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis)
Danish: • Forværring af en sjælden sygdom forbundet med muskelsvaghed (forværring af myastheni gravis)
English: Species for which acquired resistance may be a problem: Gram-negative aerobes: Acinetobacter baumannii Pseudomonas aeruginosa
Danish: Arter for hvilke erhvervet resistens kan være et problem: Gram-negative aerober: Acinetobacter baumannii Pseudomonas aeruginosa
English: This medicinal product must not be mixed with other medicinal products except those mentioned under Reconstitution.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under Rekonstituering.
English: • Imipenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-positive and gram-negative bacteria, with the exception of relatively rare carbapenem hydrolysing beta-lactamases.
Danish: • Imipenem er stabilt over for hydrolyse fra de fleste beta-lactamaser herunder penicillinaser og cefalosporinaser produceret af gram-positive og gram-negative bakterier med undtagelse af relativt sjældne carbapenem-hydrolyserende beta-lactamaser.
English: Tell your doctor about any medical condition you have or have had including: allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment) colitis or any other gastrointestinal disease any central nervous system disorders such as localized tremors or epileptic seizures liver, kidney or urinary problems
Danish: Fortæl Deres læge om enhver medicinsk tilstand De har eller har haft inklusive: allergi over for enhver medicin inklusive antibiotika (pludselige livstruende allergiske reaktioner kræver omgående lægehjælp) colitis eller enhver anden sygdom i mave-tarm-kanalen enhver sygdom i central nervesystemet såsom lokaliserede rystelser (tremor) eller epileptiske anfald lever-, nyre- eller urinproblemer
English: Hepatic function should be closely monitored during treatment with imipenem/cilastatin due to the risk of hepatic toxicity (such as increase in transaminases, hepatic failure and fulminant hepatitis).
Danish: Leverfunktionen skal monitoreres tæt under behandling med imipenem/cilastatin på grund af risikoen for levertoksicitet (såsom stigning i aminotransferaser, leversvigt og fulminant hepatitis).
English: • Disturbances in taste
Danish: • Smagsforstyrrelser
English: Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Using other medicines below).
Danish: Fortæl Deres læge, hvis De tager medicin kaldet valproinsyre eller natriumvalproat (se afsnittet Brug af anden medicin nedenfor).
English: Ureoplasma urealyticum * All methicillin-resistant staphylococci are resistant to imipenem/cilastatin.
Danish: Ureoplasma urealyticum * Alle methicillin-resistente stafylokokker er resistente over for imipenem/cilastatin.
English: Mode of action TIENAM consists of two components: imipenem and cilastatin sodium in a 1:1 ratio by weight.
Danish: Virkningsmekanisme TIENAM består af to komponenter: Imipenem og cilastatinnatrium i et vægtmæssigt forhold 1:1.
English: Very rare vertigo, tinnitus
Danish: Vertigo, tinnitus
English: Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see Incompatibility and After reconstitution): 0.9% sodium chloride.
Danish: Indholdet fra hvert hætteglas skal overføres til 100 ml af en egnet infusionsvæske (se Uforligeligheder og Efter rekonstituering): 0,9% natriumchlorid.
English: Due to the limited extent of hepatic metabolism of imipenem, its pharmacokinetics are not expected to be affected by hepatic impairment.
Danish: På grund af den begrænsede metabolisme af imipenem i leveren forventes dets farmakokinetik ikke at blive påvirket af leverinsufficiens.
English: If these side-effects occur while receiving or after receiving TIENAM, the medicine must be stopped and your doctor contacted immediately.
Danish: Hvis disse bivirkninger forekommer under eller efter indgivelse af TIENAM, skal brugen af medicinen straks stoppes, og De skal kontakte en læge med det samme.
English: • Imipenem may be actively removed from the cell with an efflux pump.
Danish: • Aktiv fjernelse af imipenem fra cellen med en efflukspumpe
English: Do not store above 25 °C.
Danish: Må ikke opbevares ved temperatur over 25°C.
English: • Hypersensitivity to the active substances or to any of the excipients
Danish: • Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne
English: Imipenem and cilastatin are excreted into the mother's milk in small quantities.
Danish: Imipenem og cilastatin udskilles i human mælk i små mængder.
English: Similarly, the most frequently reported local adverse reactions were phlebitis/thrombophlebitis (3.1%), pain at the injection site (0.7%), erythema at the injection site (0.4%) and vein induration (0.2%).
Danish: Tilsvarende var de hyppigst rapporterede lokale bivirkninger: flebitis/tromboflebitis (3,1%), smerter på injektionsstedet (0,7%), erytem på injektionsstedet (0,4%) samt veneinduration (0,2%).
English: Cilastatin sodium is a competitive, reversible and specific inhibitor of dehydropeptidase-I, the renal enzyme which metabolizes and inactivates imipenem.
Danish: Cilastatinnatrium er en kompetitiv, reversibel og specifik hæmmer af dehydropeptidase-I, det renale enzym, som metaboliserer og inaktiverer imipenem.
English: Rare pseudomembranous colitis, candidiasis
Danish: Pseudomembranøs kolit, candidiasis
English: There is no target-based cross-resistance between imipenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes.
Danish: Der er ingen målbaseret krydsresistens mellem imipenem og antibiotika af quinolon-, aminoglykosid-, makrolid- og tetracyclinklasserne.
English: Approximately 70-80% of the dose of cilastatin was recovered unchanged in the urine as cilastatin within 10 hours of administration of TIENAM.
Danish: Ca. 70-80 % af cilastatin-dosis blev genfundet uomdannet i urinen inden for 10 timer efter administration af TIENAM.
English: Imipenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).
Danish: Imipenem udøver sin baktericide aktivitet ved at hæmme bakteriecellevægssyntesen i gram-positive og gram-negative bakterier ved hjælp af binding til penicillinbindende proteiner (PBPer).
English: • Severe skin rash with loss of skin and hair (exfoliative dermatitis)
Danish: • Alvorlige hududslæt med tab af hud og hår (exfoliativ dermatitis)
English: Imipenem, also referred to as N-formimidoyl-thienamycin, is a semi-synthetic derivative of thienamycin, the parent compound produced by the filamentous bacterium Streptomyces cattleya.
Danish: Imipenem, også omtalt som N-formimidoyl-thienamycin, er et semisyntetisk derivat af thienamycin, som er udgangsstoffet og produceres af den filamentøse bakterie Streptomyces cattleya.
English: • Dizziness, sleepiness
Danish: • Svimmelhed, søvnløshed
English: TIENAM may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.
Danish: TIENAM kan bruges til behandling af bakterieinfektion i blodet, som kan forbindes med en af ovennævnte infektionstyper.
English: The antibacterial spectrum of imipenem/cilastatin should be taken into account especially in lifethreatening conditions before embarking on any empiric treatment.
Danish: Der bør især ved livstruende tilstande tages hensyn til det antibakterielle spektrum for imipenem/cilastatin, før nogen form for empirisk behandling påbegyndes.
English: The remainder of the administered dose was recovered in the urine as antibacterially inactive metabolites, and faecal elimination of imipenem was essentially nil.
Danish: Resten af den indgivne dosis påvistes i urinen som antibakterielt inaktive metabolitter, og fækal elimination af imipenem var så godt som nul.
English: Concomitant use of an aminoglycoside may be indicated when Pseudomonas aeruginosa infections are suspected or proven to be involved in the approved indications (see section 4.1).
Danish: Samtidig anvendelse af et aminoglykosid kan være indiceret, når Pseudomonas aeruginosainfektioner er mistænkt for eller påvist at være involvert i de godkendte indikationer (se pkt.
English: Gram-positive anaerobes:
Danish: Gram-positive anaerober:
English: Co-administration of cilastatin with imipenem in a 1:1 ratio prevented the nephrotoxic effects of imipenem in rabbits and monkeys.
Danish: Samtidig administration af cilastatin og imipenem i et 1:1 forhold forebyggede den nefrotoksiske virkning af imipenem hos kaniner og aber.
English: It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of imipenem/cilastatin (see section 4.8).
Danish: Det er vigtigt at overveje denne diagnose hos patienter, som udvikler diarré under eller efter behandling med imipenem/cilastatin (se pkt.
English: 500 mg/500 mg every 6 hours OR 1000 mg/1000 mg every 8 hours OR every 6 hours
Danish: 500 mg/500 mg hver 6. time ELLER 1.000 mg/1.000 mg hver 8. time ELLER hver 6. time
English: Very rare aggravation of myasthenia gravis, headache
Danish: Forværring af myasthenia gravis, hovedpine
English: • Flushing, bluish discoloration of the face and lips, skin texture changes, excessive sweating
Danish: • Rødme, blåfarvning af ansigt og læber, forandringer i hudens struktur, ekstrem sveden
English: There have been many reports of increases in the anti-coagulant effects of orally administered anticoagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents.
Danish: Der har været mange rapporter om potenseringaf den antikoagulerende virkning af oralt administrerede antikoagulantia herunder warfarin til patienter i samtidig antibakteriel behandling.
English: The daily dose of TIENAM should be based on the type and severity of infection, the pathogen(s) isolated, the patient's renal function and body weight (see also section 4.4 and 5.1).
Danish: Den daglige dosis skal baseres på infektionstype og infektionens sværhedsgrad, isolerede patogen(er) samt patientens nyrefunktion og legemsvægt (se også pkt.
English: Clinical data are insufficient to recommend the use of TIENAM in children under 1 year of age or paediatric patients with impaired renal function (serum creatinine >2 mg/dl).
Danish: Kliniske data er utilstrækkelige til at anbefale brugen af TIENAM til børn under 1 år eller pædiatriske patienter med nedsat nyrefunktion (serumkreatinin >2 mg/dl).
English: TIENAM and associated names (see Annex I) 500 mg/500 mg powder for solution for infusion [See Annex I - To be completed nationally]
Danish: TIENAM og tilhørende navne (Se bilag I) 500 mg/500 mg pulver til infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Inherently resistant species: Gram positive aerobes: Enterococcus faecium Gram negative aerobes: Some strains of Burkholderia cepacia (formerly Pseudomonas cepacia) Legionella spp.
Danish: Naturligt resistente arter: Gram-positive aerober: Enterococcus faecium Gram-negative aerober: Nogle arter af Burkholderia cepacia (tidligere Pseudomonas cepacia) Legionella spp.
English: 20 ml Type I glass vials.
Danish: 20 ml type 1 hætteglas.
English: A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial.
Danish: En mulig fremgangsmåde er at tilsætte ca. 10 ml af den egnede infusionsvæske til hætteglasset.
English: 3 Susceptibility of staphylococci to carbapenems is inferred from the cefoxitin susceptibility.
Danish: 3 Stafylokokkers følsomhed for carbapenem er udledt fra cefoxitins følsomhed.
English: The lowered valproic acid levels can lead to inadequate seizure control; therefore, concomitant use of imipenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered (see section 4.4).
Danish: Den nedsatte koncentration af valproinsyre kan føre til utilstrækkelig anfaldskontrol; derfor bør imipenem og valproinsyre/ natriumvalproat ikke gives samtidigt, og alternativ antibakteriel eller antikonvulsiv behandling bør overvejes (se pkt.
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
Danish: Der er set alvorlige og lejlighedsvis fatale overfølsomhedsreaktioner (anafylaktiske reaktioner) hos patienter, der får beta-lactam-antibiotika.
English: Urinary recovery, renal clearance and plasma clearance of imipenem and cilastatin decrease with decreasing renal function following intravenous administration of TIENAM.
Danish: Genfinding i urinen, renal clearance og plasma-clearance for imipenem og cilastatin falder med faldende nyrefunktion efter intravenøs administration af TIENAM.
English: If you are concerned that you may have been given too much TIENAM, contact your doctor or another healthcare professional immediately.
Danish: Hvis De er bekymret for, om De kan have fået for meget TIENAM, skal De kontakte en læge eller andet sundhedspersonale med det samme.
English: Pack sizes of 1, 10 or 25 vials.
Danish: TIENAM findes i pakninger med 1, 10 eller 25 hætteglas.
English: Rare toxic epidermal necrolysis, angioedema, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis
Danish: Toksisk epidermal nekrolyse, angioødem, Stevens-Johnsons syndrom, erythema multiforme, eksfoliativ dermatit
English: Shake well and transfer the resulting mixture to the infusion solution container.
Danish: Ryst godt og overfør blandingen til beholderen med infusionsvæske.
English: These patients should not receive TIENAM unless haemodialysis is instituted within 48 hours.
Danish: Disse patienter bør ikke behandles med TIENAM med mindre hæmodialyse institueres inden for 48 timer.
English: Concomitant administration of TIENAM and probenecid resulted in minimal increases in the plasma levels and plasma half-life of imipenem.
Danish: Samtidig administration af TIENAM og probenecid medførte minimale stigninger i imipenems plasmakoncentration og plasmahalveringstid.
English: If you forget to use TIENAM
Danish: Hvis De har glemt at få TIENAM
English: Common increases in serum transaminases, increases in serum alkaline phosphatase
Danish: Stigning i serumaminotransferaser, stigning i serum alkalisk fosfatase
English: CNS adverse reactions such as myoclonic activity, confusional states, or seizures have been reported, especially when recommended doses based on renal function and body weight were exceeded.
Danish: Der er set CNS-bivirkninger i form af myoklonier, konfusion eller krampeanfald, især når de anbefalede doser, baseret på nyrefunktion og legemsvægt, blev overskredet.
English: This medicinal product is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate.
Danish: Dette præparat er kemisk uforligeligt med lactat og bør ikke blandes med opløsningsvæsker, der indeholder lactat.
English: • Hypersensitivity to any other carbapenem antibacterial agent
Danish: • Overfølsomhed over for andre carbapenem-antibiotka
English: If you stop using TIENAM
Danish: Hvis De holder op med at få TIENAM
English: TIENAM 500 mg/500 mg contains 37.6 mg of sodium (1.6 mEq) which should be taken into consideration by patients on a controlled sodium diet.
Danish: TIENAM 500 mg/500 indeholder 37,6 mg natrium (1,6 meq), hvilket bør tages i betragtning ved behandling af patienter på kontrolleret natriumdiæt.
English: Also, tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.
Danish: Fortæl også Deres læge hvis De tager valproinsyre eller natriumvalproat (der bruges til behandling af epilepsi, manio-depressiv sygdom (bipolar lidelse), migræne eller skizofreni) eller blodfortyndende medicin som f.eks. warfarin.
English: • A spinning sensation (vertigo), headache
Danish: • Snurrende bevægelsesfornemmelse (vertigo), hovedpine