natgillin/translations-raw huggingface dataset:
Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, carbapenemer, ATC-kode: J01DH51 
Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01D H51
5 Ikke-arts relaterede grænseværdier er hovedsageligt bestemt på basis of farmakokinetiske/ farmakodynamiske data og er uafhængigt af MIC-distributionen for specifikke arter. 
5 Non-species related breakpoint have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
Genfinding af aktiv (ikke-metaboliseret) imipenem i urinen faldt til ca. 60% af dosis, når TIENAM blev administreret sammen med probenecid. 
The urinary recovery of active (non-metabolized) imipenem decreased to approximately 60% of the dose when TIENAM was administered with probenecid.
Tilgængelig dokumentation tyder på, at cilastatin forebygger nefrotoksicitet ved at hindre, at imipenem trænger ind i de tubulære celler. 
Available evidence suggests that cilastatin prevents the nephrotoxicity by preventing entry of imipenem into the tubular cells.
Koncentrationen af den rekonstituerede opløsning er efter ovenstående procedure ca. 5 mg/ml for både imipenem og cilastatin. 
The concentration of the reconstituted solution following the above procedure is approximately 5 mg/ml for both imipenem and cilastatin.
• Nedsat permeabilitet af de gram-negative bakteriers ydre membran (på grund af nedsat produktion af poriner) 
• Decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins)
• Stigning i antallet af nogle hvide blodceller 
• Increase in some white blood cells
Hvis CNS-symptomerne fortsætter, skal TIENAM-dosis nedsættes eller behandlingen seponeres. 
If CNS symptoms continue, the dose of TIENAM should be decreased or discontinued.
• Hallucinationer (se, høre eller føle ting som i virkeligheden ikke er der 
• Seeing, hearing or feeling something that is not there (hallucinations)
• Psykiske forstyrrelser (såsom humørsvingninger og svækket dømmekraft) 
• Psychic disturbances (such as mood swings and impaired judgment)
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra toksicitet efter gentagne doser og genotoksicitet. 
Non-clinical data reveal no special hazard for humans based on repeated dose toxicity and genotoxicity studies.
Disse lægemidler bør ikke bruges sammen, medmindre de potentielle fordele opvejer risikoen. 
These medicinal products should not be used concomitantly unless the potential benefit outweighs the risks.
Det anbefales, at INR monitoreres hyppigt under og kort efter administration af antibiotika til patienter i behandling med orale antikoagulantia. 
It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent.
Imipenem/cilastatin er ikke egnet til behandling af denne type infektioner, medmindre patogenet allerede er identificeret og kendt for at være følsomt, eller når der er meget høj mistanke om, at de(t) mest sandsynlige patogen(er) vil være egnet til behandling. 
The use of imipenem/cilastatin is not suitable for treatment of these types of infections unless the pathogen is already documented and known to be susceptible or there is a very high suspicion that the most likely pathogen(s) would be suitable for treatment.
• Kvalme, opkastning, diarré. 
• Nausea, vomiting, diarrhoea.
Tyskland: ZIENAM 
Germany: ZIENAM
• Allergiske reaktioner inklusive udslæt, hævelse af ansigt, læber, tunge og/eller hals (med åndedræts eller synkebesvær) og/eller lavt blodtryk. 
• Allergic reactions including rash, swelling of the face, lips, tongue and/or throat (with difficulty in breathing or swallowing), and/or low blood pressure.
Der bør være særlig opmærksomhed på neurologiske symptomer eller kramper hos børn med kendte risikofaktorer for krampeanfald eller som er i samtidig behandling med lægemidler, som nedsætter krampetærsklen. 
Special awareness should be made to neurological symptoms or convulsions in children with known risk factors for seizures, or on concomitant treatment with medicinal products lowering the seizures threshold.
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. 
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
• Alvorlige hudreaktioner (Stevens-Johnson syndrom og erythema multiforme) 
• Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
Stenotrophomonas maltophilia (tidligere Xanthomonas maltophilia, tidligere Pseudomonas maltophilia) 
Stenotrophomonas maltophilia (formerly Xanthomonas maltophilia, formerly Pseudomonas maltophilia)
• Rysten og ukontrollerede ryk i muskler 
• Tremors and uncontrolled twitching of muscles
dosis i mg (interval i timer) 
dose in mg (interval hrs)
Arter, som er resistente over for andre carbapenemer, udviser generelt co-resistens over for imipenem. 
Species resistant to other carbapenems do generally express co-resistance to imipenem.
Risikoen for, at disse reaktioner opstår, er større hos personer, som tidligere har udvist overfølsomhed over for multiple allergener. 
These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.
Fordeling Cilastatins binding til humant serumprotein er ca. 40%. 
Distribution The binding of cilastatin to human serum proteins is approximately 40%.
Hvis 0,9% natriumchlorid af kliniske grunde ikke kan anvendes, kan 5% glucose undtagelsesvist anvendes i stedet for. 
In exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons, 5% glucose may be used instead.
3: Udledt fra cefoxitins følsomhed 
3: Inferred from cefoxitin susceptibility
Hvis anvendelse af TIENAM er nødvendig, bør fordelen ved amning for barnet opvejes mod den mulige risiko for barnet. 
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.
Anvendelse til patienter med leversygdom: Hos patienter med eksisterende leverproblemer bør leverfunktionen monitoreres under behandling med imipenem/cilastatin. 
Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with imipenem/cilastatin.
• Lokal smerte og dannelse af en fast knude på injektionsstedet 
• Local pain and formation of a firm lump at the injection site
Diarré, opkastning, kvalme Lægemiddelrelateret kvalme og/eller opkastning synes at forekomme oftere hos patienter med granulocytopeni end hos patienter, der ikke har granulocytopeni 
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
Der er ingen data vedrørende den potentielle virkning af behandling med imipenem/cilastatin på mænds eller kvinders fertilitet. 
There are no data available regarding potential effects of imipenem/cilastatin treatment on male or female fertility.
Gentag med yderligere 10 ml infusionsvæske for at sikre fuldstændig overførsel af hætteglassets indhold til infusionsvæsken. 
Repeat with an additional 10 ml of infusion solution to ensure complete transfer of vial contents to the infusion solution.
Ved disse doser faldt imipenems plasmakoncentration til under 1 g/ml i løbet af 4-6 timer. 
At these doses, plasma levels of imipenem decline to below 1 μg/ml or less in four to six hours.
Den gennemsnitlige plasmahalveringstid for imipenem og cilastatin var henholdsvis 91 ± 7,0 minutter og 69 ± 15 minutter. 
The mean plasma half-lives of imipenem and cilastatin were 91 ± 7.0 minutes and 69 ± 15 minutes, respectively.
Ca. 70 % af det indgivne antibiotikum blev genfundet uomdannet i urinen inden for 10 timer, og ingen yderligere urinudskillelse af imipenem kunne påvises. 
Approximately 70% of the administered antibiotic was recovered intact in the urine within ten hours, and no further urinary excretion of imipenem was detectable.
Nedsat nyrefunktion For at fastsætte en reduceret dosis til voksne med nedsat nyrefunktion: 
Renal impairment To determine the reduced dose for adults with impaired renal function:
Lægemidler, som hæmmer peristaltikken, bør ikke gives. 
Medicinal products that inhibit peristalsis should not be given.
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. 
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.
Doseringsanbefalingerne for TIENAM angiver den mængde af imipenem/cilastatin, der skal administreres. 
The dose recommendations for TIENAM represent the quantity of imipenem/cilastatin to be administered.
Østrig: Zienam 
Austria: Zienam
• Hævelse og rødme langs en vene, der er ekstrem øm ved berøring 
• Swelling and redness along a vein which is extremely tender when touched
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 
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.
• Ændring i antallet af blodceller 
• Changes in the amounts of blood cells
Hvis der opstår en allergisk reaktion over for TIENAM, skal behandlingen seponeres omgående. 
If an allergic reaction to TIENAM occurs, discontinue the therapy immediately.
Hæmatologi En positiv direkte eller indirekte Coombs test kan forekomme under behandling med imipenem/cilastatin. 
Haematology A positive direct or indirect Coombs test may develop during treatment with imipenem/cilastatin.
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. 
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.
Den gennemsnitlige clearance og fordelingsvolumenet for imipenem var ca. 45% højere hos pædiatriske patienter (3 måneder til 14 år) end hos voksne. 
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.
Undersøgelser hos gravide aber har vist reproduktionstoksicitet (se pkt. 
Studies in pregnant monkeys have shown reproductive toxicity (see section 5.3).
Ca. 10% blev fundet som N-acetyl-metabolitten, som har en hæmmende virkning på dehydropeptidase, der er sammenlignelig med cilastatins. 
Approximately 10% was found as the Nacetyl metabolite, which has inhibitory activity against dehydropeptidase comparable to that of cilastatin.
• Forværring af en sjælden sygdom forbundet med muskelsvaghed (forværring af myastheni gravis) 
• Worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis)
Arter for hvilke erhvervet resistens kan være et problem: Gram-negative aerober: Acinetobacter baumannii Pseudomonas aeruginosa 
Species for which acquired resistance may be a problem: Gram-negative aerobes: Acinetobacter baumannii Pseudomonas aeruginosa
Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under Rekonstituering. 
This medicinal product must not be mixed with other medicinal products except those mentioned under Reconstitution.
• 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. 
• 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.
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 
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
Leverfunktionen skal monitoreres tæt under behandling med imipenem/cilastatin på grund af risikoen for levertoksicitet (såsom stigning i aminotransferaser, leversvigt og fulminant hepatitis). 
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).
• Smagsforstyrrelser 
• Disturbances in taste
Fortæl Deres læge, hvis De tager medicin kaldet valproinsyre eller natriumvalproat (se afsnittet Brug af anden medicin nedenfor). 
Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Using other medicines below).
Ureoplasma urealyticum * Alle methicillin-resistente stafylokokker er resistente over for imipenem/cilastatin. 
Ureoplasma urealyticum * All methicillin-resistant staphylococci are resistant to imipenem/cilastatin.
Virkningsmekanisme TIENAM består af to komponenter: Imipenem og cilastatinnatrium i et vægtmæssigt forhold 1:1. 
Mode of action TIENAM consists of two components: imipenem and cilastatin sodium in a 1:1 ratio by weight.
Vertigo, tinnitus 
Very rare vertigo, tinnitus
Indholdet fra hvert hætteglas skal overføres til 100 ml af en egnet infusionsvæske (se Uforligeligheder og Efter rekonstituering): 0,9% natriumchlorid. 
Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see Incompatibility and After reconstitution): 0.9% sodium chloride.
På grund af den begrænsede metabolisme af imipenem i leveren forventes dets farmakokinetik ikke at blive påvirket af leverinsufficiens. 
Due to the limited extent of hepatic metabolism of imipenem, its pharmacokinetics are not expected to be affected by hepatic impairment.
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. 
If these side-effects occur while receiving or after receiving TIENAM, the medicine must be stopped and your doctor contacted immediately.
• Aktiv fjernelse af imipenem fra cellen med en efflukspumpe 
• Imipenem may be actively removed from the cell with an efflux pump.
Må ikke opbevares ved temperatur over 25°C. 
Do not store above 25 °C.
• Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne 
• Hypersensitivity to the active substances or to any of the excipients
Imipenem og cilastatin udskilles i human mælk i små mængder. 
Imipenem and cilastatin are excreted into the mother's milk in small quantities.
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%). 
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%).
Cilastatinnatrium er en kompetitiv, reversibel og specifik hæmmer af dehydropeptidase-I, det renale enzym, som metaboliserer og inaktiverer imipenem. 
Cilastatin sodium is a competitive, reversible and specific inhibitor of dehydropeptidase-I, the renal enzyme which metabolizes and inactivates imipenem.
Pseudomembranøs kolit, candidiasis 
Rare pseudomembranous colitis, candidiasis
Der er ingen målbaseret krydsresistens mellem imipenem og antibiotika af quinolon-, aminoglykosid-, makrolid- og tetracyclinklasserne. 
There is no target-based cross-resistance between imipenem and agents of the quinolone, aminoglycoside, macrolide and tetracycline classes.
Ca. 70-80 % af cilastatin-dosis blev genfundet uomdannet i urinen inden for 10 timer efter administration af TIENAM. 
Approximately 70-80% of the dose of cilastatin was recovered unchanged in the urine as cilastatin within 10 hours of administration of TIENAM.
Imipenem udøver sin baktericide aktivitet ved at hæmme bakteriecellevægssyntesen i gram-positive og gram-negative bakterier ved hjælp af binding til penicillinbindende proteiner (PBPer). 
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).
• Alvorlige hududslæt med tab af hud og hår (exfoliativ dermatitis) 
• Severe skin rash with loss of skin and hair (exfoliative dermatitis)
Imipenem, også omtalt som N-formimidoyl-thienamycin, er et semisyntetisk derivat af thienamycin, som er udgangsstoffet og produceres af den filamentøse bakterie Streptomyces cattleya. 
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.
• Svimmelhed, søvnløshed 
• Dizziness, sleepiness
TIENAM kan bruges til behandling af bakterieinfektion i blodet, som kan forbindes med en af ovennævnte infektionstyper. 
TIENAM may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.
Der bør især ved livstruende tilstande tages hensyn til det antibakterielle spektrum for imipenem/cilastatin, før nogen form for empirisk behandling påbegyndes. 
The antibacterial spectrum of imipenem/cilastatin should be taken into account especially in lifethreatening conditions before embarking on any empiric treatment.
Resten af den indgivne dosis påvistes i urinen som antibakterielt inaktive metabolitter, og fækal elimination af imipenem var så godt som nul. 
The remainder of the administered dose was recovered in the urine as antibacterially inactive metabolites, and faecal elimination of imipenem was essentially nil.
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. 
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).
Gram-positive anaerober: 
Gram-positive anaerobes:
Samtidig administration af cilastatin og imipenem i et 1:1 forhold forebyggede den nefrotoksiske virkning af imipenem hos kaniner og aber. 
Co-administration of cilastatin with imipenem in a 1:1 ratio prevented the nephrotoxic effects of imipenem in rabbits and monkeys.
Det er vigtigt at overveje denne diagnose hos patienter, som udvikler diarré under eller efter behandling med imipenem/cilastatin (se pkt. 
It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of imipenem/cilastatin (see section 4.8).
500 mg/500 mg hver 6. time ELLER 1.000 mg/1.000 mg hver 8. time ELLER hver 6. time 
500 mg/500 mg every 6 hours OR 1000 mg/1000 mg every 8 hours OR every 6 hours
Forværring af myasthenia gravis, hovedpine 
Very rare aggravation of myasthenia gravis, headache
• Rødme, blåfarvning af ansigt og læber, forandringer i hudens struktur, ekstrem sveden 
• Flushing, bluish discoloration of the face and lips, skin texture changes, excessive sweating
Der har været mange rapporter om potenseringaf den antikoagulerende virkning af oralt administrerede antikoagulantia herunder warfarin til patienter i samtidig antibakteriel behandling. 
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.
Den daglige dosis skal baseres på infektionstype og infektionens sværhedsgrad, isolerede patogen(er) samt patientens nyrefunktion og legemsvægt (se også pkt. 
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).
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). 
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).
TIENAM og tilhørende navne (Se bilag I) 500 mg/500 mg pulver til infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt] 
TIENAM and associated names (see Annex I) 500 mg/500 mg powder for solution for infusion [See Annex I - To be completed nationally]
Naturligt resistente arter: Gram-positive aerober: Enterococcus faecium Gram-negative aerober: Nogle arter af Burkholderia cepacia (tidligere Pseudomonas cepacia) Legionella spp. 
Inherently resistant species: Gram positive aerobes: Enterococcus faecium Gram negative aerobes: Some strains of Burkholderia cepacia (formerly Pseudomonas cepacia) Legionella spp.
20 ml type 1 hætteglas. 
20 ml Type I glass vials.
En mulig fremgangsmåde er at tilsætte ca. 10 ml af den egnede infusionsvæske til hætteglasset. 
A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial.
3 Stafylokokkers følsomhed for carbapenem er udledt fra cefoxitins følsomhed. 
3 Susceptibility of staphylococci to carbapenems is inferred from the cefoxitin susceptibility.
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. 
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).
Der er set alvorlige og lejlighedsvis fatale overfølsomhedsreaktioner (anafylaktiske reaktioner) hos patienter, der får beta-lactam-antibiotika. 
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
Genfinding i urinen, renal clearance og plasma-clearance for imipenem og cilastatin falder med faldende nyrefunktion efter intravenøs administration af TIENAM. 
Urinary recovery, renal clearance and plasma clearance of imipenem and cilastatin decrease with decreasing renal function following intravenous administration of TIENAM.
Hvis De er bekymret for, om De kan have fået for meget TIENAM, skal De kontakte en læge eller andet sundhedspersonale med det samme. 
If you are concerned that you may have been given too much TIENAM, contact your doctor or another healthcare professional immediately.
TIENAM findes i pakninger med 1, 10 eller 25 hætteglas. 
Pack sizes of 1, 10 or 25 vials.