FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The impact of age on the pharmacokinetics of doripenem was evaluated in healthy elderly male and female subjects (66-84 years of age).
Danish: Alderens betydning for doripenems farmakokinetik blev evalueret hos ældre forsøgspersoner af begge køn (66-84 år).
English: Common: pruritus, rash
Danish: Almindelig: pruritus, udslæt
English: - If you get bloody diarrhoea before, during or after your treatment with Doribax (Clostridium
Danish: - Hvis du får blodig diaré før, under eller efter behandlingen med Doribax (Clostridium difficile colitis).
English: In an interaction study, the mean doripenem AUC increased by 75% following co-administration with probenecid.
Danish: I et interaktionsstudie steg den gennemsnitlige doripenem-AUC med 75 % efter samtidig indgift af probenecid.
English: Methicillin-resistant staphylococci should always be considered as resistant to doripenem.
Danish: Methicillinresistente stafylokokker bør altid betragtes som resistente over for doripenem.
English: The selection of doripenem 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: Ved valg af doripenem til behandling af den enkelte patient skal der tages højde for, om det vil være hensigtsmæssigt at anvende et carbapenem-antibiotikum ud fra faktorer såsom infektionens sværhedsgrad, hyppigheden af resistens over for andre egnede antibakterielle midler og risikoen for selektion af carbapenemresistente bakterier.
English: Doripenem AUC was 13% higher in females compared to males.
Danish: Doripenems AUC var 13 % højere hos kvinder end hos mænd.
English: This is because you may have a condition known as colitis (an inflammation of the bowel).
Danish: Det skyldes, at du måske kan have tarmbetændelse (en tilstand, som kaldes colitis).
English: The effect of race on doripenem pharmacokinetics was examined through a population pharmacokinetic analysis.
Danish: Racens betydning for doripenems farmakokinetik blev undersøgt i en farmakokinetisk populationsanalyse.
English: Doribax should not be inhaled as it may cause inflammation of the lung (pneumonitis).
Danish: Doribax må ikke inhaleres, da det kan forårsage betændelse (inflammation) i lungerne (pneumonitis).
English: Continuous renal replacement therapy
Danish: Kontinuerlig renal substitutionsterapi
English: The metabolite lacks target pharmacological activity but other possible pharmacological effects are unknown.
Danish: Metabolitten udviser ikke den tilsigtede farmakologiske aktivitet, men det er ukendt, om den har andre farmakologiske virkninger.
English: The rash resolved within 10 days after doripenem administration was discontinued.
Danish: Udslættet forsvandt inden for 10 dage efter seponering af doripenem.
English: Doripenem exerts its bactericidal activity by inhibiting bacterial cell wall biosynthesis.
Danish: Doripenem udøver sin baktericide aktivitet ved at inhibere bakteriecellevæggens biosyntese.
English: - Serious skin reactions, with a widespread rash with peeling skin and blisters in the mouth, eyes and genitals (toxic epidermal necrolysis or Stevens-Johnson syndrome).
Danish: - Alvorlige hudreaktioner med et udbredt udslæt med hudafskalning og blærer i mund og øjne og på kønsorganer (toksisk epidermal nekrolyse eller Stevens-Johnsons syndrom).
English: Adverse drug reactions that led to Doribax discontinuation were nausea (0.1%), diarrhoea (0.1%), pruritus (0.1%), vulvomycotic infection (0.1%), hepatic enzyme increased (0.2%) and rash (0.2%).
Danish: De bivirkninger, som førte til seponering af Doribax, var kvalme (0,1 %), diaré (0,1 %), pruritus (0,1 %), svampeinfektion i vulva (0,1 %), forhøjelse af leverenzymer (0,2 %) og udslæt (0,2 %).
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Bacterial resistance mechanisms that effect doripenem include active substance inactivation by carbapenem-hydrolysing enzymes, mutant or acquired PBPs, decreased outer membrane permeability and active efflux.
Danish: De bakterielle resistensmekanismer, der påvirker doripenem, omfatter inaktivering af det aktive stof forårsaget af carbapenemhydrolyserende enzymer, muterede eller erhvervede PBP'er, reduceret ydre membranpermeabilitet og aktivt effluks.
English: Serious acute hypersensitivity (anaphylactic) reactions require immediate
Danish: Alvorlige akutte overfølsomhedsreaktioner (anafylaksi) kræver øjeblikkelig akutbehandling.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same
Danish: Hvis tidsfristen for en periodisk, opdateret sikkerhedsindberetning (PSUR) og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Overall, 54% of patients had a persistent complication, 9% had concurrent bacteraemia and 23% were infected with a levofloxacin
Danish: I alt havde 54 % af patienterne en persisterende komplikation, 9 % havde samtidig bakteriæmi, og 23 % var inficeret med et levofloxacinresistent uropatogen ved baseline.
English: Your doctor will decide whether you should use Doribax in combination with these other medicines.
Danish: Din læge vil beslutte, om du kan bruge Doribax i kombination med disse lægemidler.
English: Common: nausea, diarrhoea Uncommon: C. difficile colitis (see section 4.4)
Danish: Almindelig: kvalme, diaré Ikke almindelig: C. difficile-colitis (se pkt.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of Doribax (see section
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter, som får diaré under eller efter indgift af Doribax (se pkt.
English: Of these, 50% had late-onset VAP (defined as that occurring after five days of mechanical ventilation), 54% had an APACHE (Acute Physiology And Chronic Health Evaluation) II score > 15 and 32% received concomitant aminoglycosides (76% for more than 3 days).
Danish: Af disse havde 50 % sent opstået respiratorassocieret pneumoni (defineret som opstået efter 5 dages mekanisk ventilation), 54 % havde en APACHE (akut fysiologisk og kronisk helbredsevaluering) II-score på > 15, og 32 % fik samtidig aminoglykosider (76 % i mere end 3 dage).
English: Following dilution in the infusion bag, Doribax infusions stored at room temperature or under refrigeration should be completed according to the times in the following table:
Danish: Efter fortynding i infusionsposen skal Doribax-infusionsvæske, som opbevares ved stuetemperatur eller i køleskab, indgives i henhold til følgende skema:
English: If the doripenem dose is increased beyond the recommended dose for continuous renal replacement therapy, the systemic exposure of the doripenem-M-1 metabolite is even further increased.
Danish: Hvis dosis af doripenem øges til et højere niveau end den anbefalede dosis ved kontinuerlig renal substitutionsterapi, øges den systemiske eksponering for doripenem-M-1-metabolitten endnu mere.
English: The recommended dose and administration by infection is shown in the following table:
Danish: Dosering Den anbefalede dosis og indgivelsesmåde ved infektion er vist i følgende tabel:
English: Dextrose 50 mg/ml (5%) solution for injection should not be used for infusion durations greater than 1 hour.
Danish: 50 mg/ml (5 %) glucoseinjektionsvæske bør ikke bruges til infusioner af varighed på mere end 1 time.
English: Complicated UTI, including pyelonephritis
Danish: Kompliceret urinvejsinfektion, herunder pyelonefritis
English: In healthy young adults given a single 500 mg dose of Doribax, 71% and 15% of the dose was recovered in urine as unchanged active substance and ring-opened metabolite, respectively.
Danish: Hos raske unge voksne, som fik en enkelt dosis på 500 mg Doribax, blev 71 % og 15 % af dosis udskilt i urinen som henholdsvis uændret aktivt stof og ringåbnet metabolit.
English: Doribax is used to treat adults for the following infections: - Pneumonia (a serious type of chest or lung infection) that you catch in a hospital or similar setting.
Danish: Doribax anvendes til voksne mod følgende infektioner: - Lungebetændelse, som du smittes med på hospitalet eller lignende steder.
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have occurred in patients receiving beta-lactam antibiotics.
Danish: Alvorlige og i nogle tilfælde dødelige overfølsomhedsreaktioner (anafylaksi) er set hos patienter, som har fået betalaktamantibiotika.
English: The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to doripenem or not.
Danish: Nedenstående information er udelukkende vejledende for sandsynligheden for, om mikroorganismen er følsom over for doripenem.
English: The usual treatment duration for patients with nosocomial pneumonia, including ventilator-associated pneumonia is 10 to 14 days and is often in the upper range for patients infected with non-fermenting gram-negative pathogens (such as Pseudomonas spp.
Danish: Den sædvanlige behandlingsvarighed hos patienter med nosokomiel pneumoni inklusive respiratorassocieret pneumoni er 10-14 dage og ofte i det øverste område af intervallet hos patienter, der er inficeret med nonfermenterende gramnegative patogener (såsom Pseudomonas spp.
English: Before therapy with Doribax is started, careful inquiry should be made concerning a previous history of hypersensitivity reactions to other active substances in this class or to beta-lactam antibiotics.
Danish: Før behandling med Doribax iværksættes, bør der udspørges grundigt til tidligere overfølsomhedsreaktioner over for andre aktive stoffer af denne type eller over for betalaktamantibiotika.
English: Additive activity or weak synergy with amikacin and levofloxacin has been seen for Pseudomonas aeruginosa and for gram-positive bacteria with daptomycin, linezolid, levofloxacin, and
Danish: Der er set additiv aktivitet eller svag synergi med amikacin og levofloxacin over for Pseudomonas aeruginosa og for grampositive bakterier med daptomycin, linezolid, levofloxacin og vancomycin.
English: S  1 mg/l and R > 4 mg/l
Danish: S  1 mg/l og R > 1 mg/l
English: Doripenem 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: Doripenem er stabilt over for hydrolyse forårsaget af de fleste betalaktamaser, bl.a. penicillinaser og cefalosporinaser produceret af grampositive og gramnegative bakterier, bortset fra relativt sjældne carbapenemhydrolyserende betalaktamaser.
English: These dosing recommendations were derived by modeling data from subjects with end stage renal disease receiving continuous renal replacement therapy, and take into consideration the potential increases in non-renal clearance of carbapenems in patients with acute renal insufficiency compared to patients with chronic renal impairment.
Danish: Disse dosisrekommandationer er udarbejdet ud fra data fra forsøgspersoner med nyresygdom i terminalstadiet, der fik kontinuerlig renal substitutionsterapi, og de tager højde for den potentielle stigning i non-renal clearance af carbapenemer hos patienter med akut nyreinsufficiens sammenlignet med patienter med kronisk nyreinsufficiens.
English: Doribax solutions for infusion range from clear, colourless solutions to solutions that are clear and slightly yellow.
Danish: Doribax infusionsvæsker varierer fra klare, farveløse opløsninger til opløsninger, som er klare og let gullige.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin, eller har gjort det for nylig.
English: Similar to other beta-lactam antimicrobial agents, the time that the plasma concentration of doripenem exceeds the minimum inhibitory concentration (%T>MIC) of the infecting organism has been shown to best correlate with efficacy in pre-clinical pharmacokinetic/pharmacodynamic (PK/PD) studies.
Danish: Ligesom for andre betalaktamantibiotika er det påvist, at den tid, hvori doripenems plasmakoncentration overskrider infektionsorganismens mindste hæmmende koncentration (%T > MIC), bedst korrelerer med effekten i prækliniske farmakokinetiske/farmakodynamiske (PK/PD) studier.
English: Common: phlebitis
Danish: Almindelig: flebitis
English: The pharmacokinetics of doripenem in patients with hepatic impairment have not been established.
Danish: Doripenems farmakokinetik hos patienter med nedsat leverfunktion er ikke fastsat.
English: As doripenem does not appear to undergo hepatic metabolism, the pharmacokinetics of doripenem are not expected to be affected by hepatic impairment.
Danish: Eftersom doripenem ikke synes at blive metaboliseret i leveren, forventes doripenems farmakokinetik ikke at være påvirket af nedsat leverfunktion.
English: Pneumonitis with inhalational use
Danish: Pneumonitis ved anvendelse til inhalation
English: In an interaction study, the serum concentrations of valproic acid were markedly reduced (AUC was reduced by 63%) following co-administration of doripenem and valproic acid.
Danish: I et interaktionsstudie forekom der markante fald i serumkoncentrationen af valproinsyre (AUC blev reduceret med 63 %) efter samtidig indgift af doripenem og valproinsyre.
English: Doribax contains the active substance doripenem.
Danish: Doribax indeholder det aktive stof doripenem.
English: Extending the infusion time of doripenem to 4 hours maximises the % T>MIC for a given dose and is the basis for the option to administer 4-hour infusions in patients with nosocomial pneumonia including ventilator-associated pneumonia.
Danish: Hvis infusionstiden for doripenem forlænges til 4 timer, maksimeres %T > MIC for en given dosis, og dette danner grundlaget for muligheden for at give infusioner med en varighed på 4 timer til patienter med nosokomiel pneumoni herunder respiratorassocieret pneumoni.
English: Therefore, it may not be excluded that the exposure obtained in patients receiving continuous renal replacement therapy will be higher than estimated and thus higher than metabolite exposures observed with a 1-hour infusion of 1 g doripenem every 8 hours in healthy subjects.
Danish: Det kan derfor ikke udelukkes, at den eksponering, der opnås hos patienter, der får kontinuerlig renal substitutionsterapi, vil være højere end estimeret og dermed højere end den eksponering for metabolitten, som sås hos raske forsøgspersoner efter infusion af 1 g doripenem over 1 time hver 8. time.
English: The medicinal product is supplied in cartons containing 10 vials.
Danish: Lægemidlet udleveres i æsker med 10 hætteglas.
English: Tell your doctor if you are taking: - valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines or
Danish: Fortæl det til lægen, hvis du tager: - valproinsyre eller natriumvalproat (bruges til behandling af epilepsi, bipolar lidelse
English: The clinical cure rate at the end of treatment visit on day 10 was numerically lower for subjects in the doripenem arm of the primary microbiological intent-to-treat (MITT) (45.6% versus 56.8%; 95% CI: -26.3%; 3.8%) and co-primary microbiologically evaluable (ME) (49.1% [28/57] versus 66.1% [39/59]); 95% CI: -34.7%; 0.8%) analysis sets.
Danish: Den kliniske helbredelsesrate ved afslutningen af behandlingen på dag 10 var numerisk lavere for forsøgspersoner i doripenem-armen i det primære mikrobiologiske intent-to-treat- (MITT-) analysesæt (45,6 % versus 56,8 %; 95 % CI: -26,3 %; 3,8 %) og det co-primære mikrobiologisk evaluerbare (ME-) analysesæt (49,1 % [28/57] versus 66,1 % [39/59]); 95 % CI -34,7 %; 0,8 %).
English: What you need to know before you use Doribax
Danish: Det skal du vide, før du begynder at bruge Doribax
English: As with other antimicrobial agents, including carbapenems, doripenem has been shown to select for resistant bacterial strains.
Danish: Som det kendes fra andre antibiotika, bl.a. carbapenem, er doripenem vist at selektere for resistente bakteriestammer.
English: Target attainment (MIC)
Danish: Mål (MIC)
English: Uncommon side effects (may affect up to 1 in 100 people): - Decrease of blood platelet count which may increase your risk of bruising and bleeding - Decrease of white blood cells which may increase your risk of infections
Danish: Ikke almindelige (forekommer hos mellem 1 og 10 ud af 1.000 patienter): - Nedsat antal blodplader i blodet, hvilket kan øge risikoen for at få blå mærker eller bløde - Nedsat antal hvide blodlegemer, hvilket kan øge risikoen for infektioner - Krampeanfald.
English: Monte Carlo simulations using pathogen susceptibility results from completed phase III trials and population PK data indicated that the %T>MIC target of 35% was achieved in greater than 90% of patients with nosocomial pneumonia, complicated urinary tract infections and complicated intra-abdominal infections, for all degrees of renal function.
Danish: For alle grader af nyrefunktion indikerer Monte Carlo-simuleringer med patogenfølsomhedsresultater fra afsluttede fase III-studier og farmakokinetiske populationsdata, at %T > MIC-målet på 35 % blev nået hos mere end 90 % af patienterne med nosokomiel pneumoni, komplicerede urinvejsinfektioner og komplicerede intraabdominale infektioner.
English: Caution on the choice of antibiotic agent and dose should be taken when treating patients with late-onset ventilator-associated pneumonia (> 5 days hospitalisation) and in other nosocomial pneumonia cases where pathogens with decreased susceptibility are suspected or confirmed, such as Pseudomonas spp.
Danish: Forsigtighed tilrådes ved valg af antibakterielt middel og dosis ved behandling af patienter med sen respiratorassocieret pneumoni (>5 dages indlæggelse) og ved andre tilfælde af nosokomiel pneumoni, hvor der er mistanke om eller påvist patogener med nedsat følsomhed såsom Pseudomonas spp.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2C-8C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis præparatet ikke anvendes straks, er opbevaringstiden og betingelserne inden anvendelse brugerens ansvar og bør normalt ikke være over 24 timer ved 2-8 °C, medmindre rekonstitution/fortynding er foretaget under kontrollerede og validerede aseptiske forhold.
English: Following the administration of a single 500 mg dose of radiolabeled doripenem to healthy young adults, less than 1% of the total radioactivity was recovered in faeces.
Danish: Efter indgift af en enkelt dosis på 500 mg radioaktivt mærket doripenem til raske unge voksne blev mindre end 1 % af den samlede radioaktivitet udskilt med fæces.
English: The expiry date refers to the last
Danish: Udløbsdatoen er den sidste dag i den nævnte måned.
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, hvis der er mistanke om eller det er påvist, at Pseudomonas aeruginosa-infektioner er involveret i de godkendte indikationer (se pkt.
English: Luxembourg/Luxemburg JANSSEN-CILAG NV/SA Belgique/Belgien Tél/Tel: +32 14 64 94 11
Danish: België/Belgique/Belgien JANSSEN-CILAG NV/SA Tel/Tél: + 32 14 64 94 11
English: In 3,142 adult patients (1,817 of which received Doribax) evaluated for safety in phase II and phase III clinical trials, adverse reactions due to Doribax 500 mg every 8 hours occurred at a rate of 32%.
Danish: Hos 3.142 voksne patienter (hvoraf 1.817 fik Doribax), som blev evalueret for sikkerhed i kliniske fase II- og fase III-studier, forekom der bivirkninger hos 32 % på grund af Doribax 500 mg indgivet hver 8. time.
English: Metabolism of doripenem to a microbiologically inactive ring-opened metabolite occurs primarily via dehydropeptidase-I. Doripenem undergoes little to no Cytochrome P450 (CYP450) mediated metabolism.
Danish: Doripenem metaboliseres til en mikrobiologisk inaktiv ringåbnet metabolit hovedsagelig via dehydropeptidase-I. Doripenem gennemgår ringe eller ingen cytokrom P450-medieret (CYP450) metabolisme.
English: There are no clinical data available regarding potential effects of doripenem treatment on male or female fertility.
Danish: Der foreligger ingen kliniske data om doripenems potentielle virkning på fertiliteten hos hanner og hunner.
English: Description of the patient population treated in clinical studies In two clinical trials of patients with nosocomial pneumonia (N=979), 60% of the clinically-evaluable Doribax-treated patients had ventilator-associated pneumonia (VAP).
Danish: Beskrivelse af patientgruppen, der er blevet behandlet i kliniske studier I to kliniske studier med patienter med nosokomiel pneumoni (N = 979) havde 60 % af de klinisk evaluerbare Doribax-behandlede patienter respiratorassocieret pneumoni.
English: - Complicated urinary tract infections, including kidney infections and cases that have spread to
Danish: - Komplicerede urinvejsinfektioner, bl.a. nyrebetændelse og infektioner, som har spredt sig til blodet.
English: There is no accumulation of doripenem following multiple intravenous infusions of either 500 mg or 1 g administered every 8 hours for 7 to 10 days in subjects with normal renal function.
Danish: Der er ingen akkumulation af doripenem efter flere intravenøse infusioner af enten 500 mg eller 1 g indgivet hver 8. time i 7-10 dage til personer med normal nyrefunktion.
English: In two clinical trials of patients with complicated urinary tract infections (N=1,179), 52% of microbiologically-evaluable Doribax-treated patients had complicated lower urinary tract infections and 48% had pyelonephritis, of which 16% were complicated.
Danish: I to kliniske studier med patienter med komplicerede urinvejsinfektioner (N = 1.179) havde 52 % af de mikrobiologisk evaluerbare Doribax-behandlede patienter komplicerede nedre urinvejsinfektioner, og 48 % havde pyelonefritis, 16 % af disse var komplicerede.
English: In patients prescribed 1 g every 8 hours as a 4-hour infusion, the dose should be similarly adjusted (moderate renal impairment: 500 mg every 8 hours; severe renal impairment: 500 mg every 12 hours).
Danish: Til patienter, der har fået ordineret 1 g hver 8. time som 4 timers infusion, skal dosis justeres tilsvarende (ved moderat nedsat nyrefunktion til 500 mg hver 8. time; ved svært nedsat nyrefunktion til 500 mg hver 12. time).
English: Tell your doctor or pharmacist before using Doribax if: - You are pregnant or think you may be pregnant.
Danish: Graviditet og amning Fortæl det til lægen eller apotekspersonalet, før du bruger Doribax, hvis: - du er gravid eller har mistanke om, at du er gravid.
English: ** Based mainly on PK/PD considerations, a 4-hour infusion time may be more suitable for infection with less susceptible pathogens (see section 5.1).
Danish: ** Hovedsageligt baseret på farmakokinetiske/farmakodynamiske overvejelser kan en infusion af 4 timers varighed være mere hensigtsmæssig ved infektion med mindre følsomme patogener (se pkt.