FrancophonIA/ELRC3.0 huggingface dataset:
English: After commencing treatment with intravenous doripenem, a switch to appropriate oral therapy to complete the treatment course is possible once clinical improvement has been established.
Danish: Så snart der er opnået en klinisk forbedring efter påbegyndt intravenøs behandling med doripenem, kan der skiftes til passende oral behandling for at fuldende behandlingsforløbet.
English: Administration of doripenem, like other antibiotics, has been associated with emergence and selection of strains with reduced susceptibility.
Danish: Som for andre antibiotika er indgift af doripenem forbundnet med fremkomst og selektion af stammer med nedsat følsomhed.
English: AUC of the microbiologically inactive ring-opened metabolite (doripenem-M-1) is expected to be considerably increased in patients with severe renal impairment compared with healthy subjects.
Danish: AUC for den mikrobiologisk inaktive ringåbnede metabolit (doripenem-M-1) forventes at være betydelig forhøjet hos patienter med svært nedsat nyrefunktion sammenlignet med patienter med en normal nyrefunktion.
English: For storage conditions after reconstitution of the medicinal product, and infusion solutions, see section
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet og for infusionsvæsken, se pkt.
English: In seriously ill patients or those with an impaired immune response, a 4-hour infusion time may be more suitable when the MIC of doripenem for the known or suspected pathogen(s) has been shown or is expected to be > 0.5 mg/l, in order to reach a target attainment of 50% T>MIC in at least 95% of the patients (see section 4.2).
Danish: En infusion af 4 timers varighed kan være mere hensigtsmæssig til alvorligt syge patienter eller patienter med svækket immunforsvar, når MIC for doripenem over for de(t) kendte eller mistænkte patogen(er) er bestemt til eller forventes at være > 0,5 mg/l for at nå målet på 50 % T>MIC hos mindst 95 % af patienterne (se pkt.
English: For patients with acute renal insufficiency on CRRT, an infusion time of 4 hours is required, taking into consideration the possible increases in non-renal clearance of carbapenems in patients with acute renal insufficiency.
Danish: Hos patienter med akut nyreinsufficiens, der får CRRT, er en infusionstid på 4 timer nødvendig på grund af den potentielle stigning i non-renal clearance af carbapenemer hos patienter med akut nyreinsufficiens.
English: Staphylococcus aureus (methicillin susceptible strains only) Staphylococcus spp.
Danish: Staphylococcus aureus (kun methicillinfølsomme stammer)*^ Staphylococcus spp.
English: Doribax dosing and administration recommendations for patients on continuous renal replacement therapies are shown in the following table.
Danish: Anbefalinger til dosering og administration af Doribax til patienter, der er i kontinuerlig renal substitutionsterapi, fremgår af tabellen nedenfor:
English: - Central nervous system disorders such as stroke or history of seizures.
Danish: - Lidelser i centralnervesystemet såsom slagtilfælde eller tidligere anfald af kramper.
English: Monte Carlo simulations supported the use of 500 mg 4-hour infusions every 8 hours in subjects with normal renal function for target pathogens with doripenem MICs  4 mg/l.
Danish: Carlo-simuleringer understøttede anvendelsen af infusion med 500 mg over 4 timer hver 8. time til patienter med normal nyrefunktion for målpatogener med MIC-værdier for doripenem på  4 mg/l.
English: Doripenem is a synthetic carbapenem antibacterial agent.
Danish: Virkningsmekanisme Doripenem er et syntetisk carbapenemantibiotikum.
English: Intravenous injection of doripenem had no adverse effects on general fertility of treated male and female rats or on postnatal development and reproductive performance of the offspring at doses as high as 1 g/kg/day (based on AUC, at least equal to the exposure to humans at the dose of 500 mg administered every 8 hours).
Danish: Efter intravenøs injektion havde doripenem ingen negative virkninger på den generelle fertilitet hos behandlede han- og hunrotter eller på den postnatale udvikling og reproduktionsevnen hos afkommet ved doser op til 1 g/kg/dag (baseret på AUC, mindst svarende til eksponeringen hos mennesker ved en dosis på 500 mg administreret hver 8. time).
English: In two clinical trials of patients with complicated intra-abdominal infections (N=962) the most common anatomical site of infection in microbiologically-evaluable Doribax-treated patients was the appendix (62%).
Danish: I to kliniske studier med patienter med komplicerede intraabdominale infektioner (N = 962) var appendix det mest almindelige anatomiske infektionssted hos mikrobiologisk evaluerbare Doribaxbehandlede patienter (62 %).
English: This dose regimen is based on PK/PD data (see
Danish: Dette doseringsregime er baseret på farmakokinetiske/farmakodynamiske data (se pkt.
English: The experience in patients who are severely immunocompromised, receiving immunosuppressive therapy, and patients with severe neutropenia is limited since this population was excluded from
Danish: Der er begrænset erfaringen med patienter, som er alvorligt immunkompromitteret, er i immunsuppressiv behandling og patienter med alvorlig neutropeni, idet disse patienter var ekskluderet i fase III-studierne.
English: Doripenem undergoes little to no Cytochrome P450 (CYP450) mediated metabolism.
Danish: Doripenem gennemgår ringe eller ingen cytokrom P450-medieret (CYP450) metabolisme.
English: Should a hypersensitivity reaction to doripenem occur, it should be discontinued immediately and appropriate measures taken.
Danish: Hvis der optræder overfølsomhedsreaktioner over for doripenem, bør behandlingen straks seponeres, og relevante forholdsregler træffes.
English: Therefore, co-administration of probenecid with Doribax is not recommended.
Danish: Samtidig indgift af probenecid og Doribax frarådes derfor.
English: The pharmacokinetics of doripenem are linear over a dose range of 500 mg to 2 g when intravenously infused over 1 hour and 500 mg to 1 g when intravenously infused over 4 hours.
Danish: Doripenems farmakokinetik er lineær over et dosisområde på 500 mg til 2 g ved intravenøs infusion over 1 time og 500 mg til 1 g ved intravenøs infusion over 4 timer.
English: 250 mg doripenem.
Danish: 250 mg
English: When Doribax was used investigationally via inhalation, pneumonitis occurred.
Danish: I studier er der ved anvendelse af Doribax via inhalation opstået pneumonitis.
English: Other medicines and Doribax
Danish: Brug af anden medicin sammen med Doribax
English: Dosing recommendations for pathogens with MIC > 1 mg/l have not been established for continuous renal replacement therapy due to the potential for accumulation of doripenem and doripenem-M-1 metabolite (see sections 4.4 and 5.2).
Danish: Der er ikke fastsat doseringsrekommandationer for patogener med MIC > 1 mg/l ved kontinuerlig renal substitutionsterapi på grund af potentiel akkumulering af doripenem og dets metabolit doripenem-M-1 (se pkt.
English: Solution stored at room temperature
Danish: Opløsning opbevaret ved stuetemperatur
English: Since patients were administered only four doses of doripenem, a further decrease of valproic acid levels with longer concomitant administration cannot be excluded.
Danish: Dersom patienterne kun fik 4 doser af doripenem, kan det ikke udelukkes, at niveauet af valproinsyre kan sænkes yderligere ved samtidig indgift i længere tid.
English: Hypersensitivity to any other carbapenem antibacterial agent Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins).
Danish: Overfølsomhed over for andre carbapenemantibiotika Svær overfølsomhed (f.eks. anafylaktisk reaktion, svær hudreaktion) over for ethvert andet betalaktamantibiotikum (f.eks. penicillin eller cefalosporin).
English: Doripenem single dose pharmacokinetics after a 4-hour infusion in adults with cystic fibrosis are consistent with those in adults without cystic fibrosis.
Danish: Farmakokinetikken af en enkelt dosis doripenem givet som infusion over 4 timer er den samme hos voksne med cystisk fibrose som hos voksne uden cystisk fibrose.
English: In a phase I study in healthy subjects receiving doripenem 2 g infused over 1 hour every 8 hours for 10 to 14 days, the incidence of rash was very common (5 of 8 subjects).
Danish: I et fase I-studie hos raske forsøgspersoner, som fik 2 g doripenem infunderet over 1 time hver 8. time i 10-14 dage, var forekomsten af udslæt meget almindelig (5 ud af 8 forsøgspersoner).
English: A study of 233 patients with late-onset VAP failed to demonstrate the non-inferiority of an investigational 7-day course of doripenem (1 g every 8 hours as a 4 hour infusion) compared to a 10-day course of imipenem/cilastatin (1 g every 8 hours as a 1 hour infusion).
Danish: I et studie med 233 patienter med sen respiratorassocieret pneumoni blev der ikke påvist noninferioritet af behandling med doripenem i 7 dage (1 g hver 8. time som 4 timers infusion) versus 10 dages behandling med imipenem/cilastatin (1 g hver 8. time som 1 times infusion).
English: The safety profile in approximately 500 patients who received Doribax 1 g every 8 hours as a 4-hour infusion in phase I, II and III clinical trials, was consistent with the safety profile for patients receiving
Danish: Sikkerhedsprofilen hos ca. 500 patienter, der fik Doribax 1 g hver 8. time som infusion over 4 timer i kliniske fase I-, II- og III-studier, svarede til sikkerhedsprofilen hos patienter, der fik 500 mg hver 8. time.
English: Doripenem inactivates multiple essential penicillin-binding proteins (PBPs) resulting in inhibition of cell wall
Danish: Doripenem inaktiverer flere essentielle penicillinbindende proteiner (PBP), hvilket medfører inhibering af cellevægssyntesen med efterfølgende celledød.
English: Doripenem was given for up to 14 days in clinical studies and the safety of longer durations of therapy has not been established.
Danish: I kliniske studier blev der givet doripenem i op til 14 dage.
English: Following a single 500 mg dose of Doribax, doripenem AUC increased 1.6-fold, 2.8-fold, and 5.1-fold in subjects with mild (CrCl 51-79 ml/min), moderate (CrCl 31-50 ml/min), and severe renal impairment (CrCl  30 ml/min), respectively, compared to age-matched healthy subjects with normal renal function (CrCl > 80 ml/min).
Danish: Efter en enkelt dosis på 500 mg Doribax steg AUC for doripenem 1,6-gange, 2,8-gange og 5,1-gange hos forsøgspersoner med henholdsvis let (CrCl 51-79 ml/min), moderat (CrCl 31-50 ml/min) og svært (CrCl  30 ml/min) nedsat nyrefunktion sammenlignet med raske forsøgspersoner i samme aldersgruppe med normal nyrefunktion (CrCl > 80 ml/min).
English: sodium chloride 9 mg/ml (0.9%) solution for injection
Danish: 9 mg/ml (0,9 %) natriumchloridinjektionsvæske
English: There is insufficient information to make dose adjustment recommendations in patients on intermittent haemodialysis or dialysis methods other than continuous renal replacement therapy (see section 4.2).
Danish: Der foreligger utilstrækkelig information til at kunne give rekommandationer for dosisjustering for patienter, der får intermitterende hæmodialyse eller andre former for dialyse end kontinuerlig renal substitutionsterapi (se pkt.
English: Seizures in clinical trials with doripenem occurred most commonly in those with pre-existing central nervous system (CNS) disorders (e.g. stroke or history of seizures), compromised renal function and at doses greater than 500 mg.
Danish: I kliniske studier med doripenem forekom krampeanfald hyppigst hos patienter med eksisterende lidelser i centralnervesystemet (f.eks. apopleksi eller anamnese med kramper), ved nedsat nyrefunktion samt ved doser over 500 mg.
English: Dosing recommendations for patients on continuous renal replacement therapy were developed to achieve doripenem systemic exposures similar to subjects with normal renal function who receive doripenem 500 mg as a 1-hour infusion, to maintain doripenem concentrations above a minimum inhibitory concentration of 1 mg/l for at least 35% of the dosing interval, and to maintain doripenem and doripenem-M-1 metabolite exposures below those observed with a 1-hour infusion of 1 g doripenem every 8 hours in healthy subjects.
Danish: Der er udarbejdet dosisrekommandationer for patienter i kontinuerlig renal substitutionsterapi med henblik på at opnå samme systemiske eksponering for doripenem som hos personer med normal nyrefunktion, der får infusion af doripenem 500 mg over 1 time, så koncentrationerne af doripenem kan fastholdes over en mindste hæmmende koncentration (MIC) på mindst 1 mg/l i mindst 35 % af intervallet mellem doserne, og for at fastholde eksponeringen for doripenem og dets metabolit doripenem-M-1 på et lavere niveau end det, der sås hos raske forsøgspersoner efter infusion af 1 g doripenem over 1 time hver 8. time.
English: For doripenem, limited clinical data on exposed pregnancies are available.
Danish: Der er begrænsede kliniske data fra anvendelse af doripenem til gravide kvinder.
English: The mean Cmax and AUC0-∞ of doripenem in healthy subjects across studies following administration of 500 mg over 1 hour are approximately 23 g/ml and 36 µg.h/ml, respectively.
Danish: Gennemsnitlig Cmax og AUC0-∞ for doripenem hos raske forsøgspersoner i forskellige studier efter indgift af 500 mg over 1 time er henholdsvis ca. 23 g/ml og 36 g x time/ml.
English: This includes pneumonia that you catch when on a machine that helps you breathe.
Danish: Dette kan f.eks. være lungebetændelse, som du smittes med, hvis du ligger i respirator.
English: Seizures have been reported during treatment with carbapenems, including doripenem (see section 4.8).
Danish: Der er rapporteret kramper ved behandling med carbapenemer inklusive doripenem (se pkt.
English: No dose adjustment is necessary in elderly patients, except in cases of moderate to severe renal impairment (see Renal impairment below and section 5.2).
Danish: Dosisjustering hos ældre patienter er ikke nødvendig undtagen i tilfælde af moderat til svært nedsat nyrefunktion (se afsnittet Nedsat nyrefunktion nedenfor samt pkt.
English: Doribax can be removed by continuous renal replacement therapy or haemodialysis (see section 5.2).
Danish: Doribax kan fjernes ved kontinuerlig renal substitutionsterapi eller hæmodialyse (se pkt.
English: The systemic exposures to doripenem and doripenem-M-1 are substantially increased in patients with end stage renal disease receiving haemodialysis compared with healthy subjects.
Danish: Systemisk eksponering for doripenem og doripenem-M-1 er væsentligt forhøjet hos patienter med nyresygdom i terminalstadiet, der er i hæmodialyse, sammenlignet med raske forsøgspersoner.
English: Powder for solution for infusion (powder for infusion)
Danish: Pulver til infusionsvæske, opløsning (pulver til infusionsvæske).
English: Adequate and well controlled studies to establish the safety and efficacy of doripenem in patients with cystic fibrosis have not been conducted.
Danish: at fastslå doripenems sikkerhed og virkning hos patienter med cystisk fibrose.
English: Therefore, your doctor will decide whether you should use Doribax while breast-feeding.
Danish: Lægen vil derfor beslutte, om du skal bruge Doribax, mens du ammer.
English: Adverse drug reactions identified during clinical trials and post-marketing experience with Doribax are listed below by frequency category.
Danish: Bivirkningerne af Doribax, der er blevet klarlagt under kliniske studier og efter markedsføring, er anført nedenfor efter frekvenskategori.
English: Time by which reconstitution, dilution and infusion must be completed for Doribax infusions solutions
Danish: Tidsfrister, inden for hvilke rekonstitution, fortynding og infusion skal finde sted for Doribax infusionsvæske, opløsning
English: The amount of doripenem and doripenem-M-1 removed during a 12-hour CVVH session was approximately 28% and 10% of the dose, respectively; and during a 12-hour CVVHDF session was approximately 21% and 8% of the dose, respectively.
Danish: I løbet af 12 timers CCVH-terapi blev der fjernet doripenem og doripenem-M-1 svarende til henholdsvis 28 % og 10 % af dosis, mens der i løbet af 12 timers CVVHDF-terapi blev fjernet henholdsvis ca. 21 % og 8 % af dosis.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 patienter): - Hovedpine
English: In patients with severe renal impairment (CrCl < 30 ml/min), the dose of doripenem should be 250 mg every 12 hours (see section 6.6).
Danish: Til patienter med svært nedsat nyrefunktion (CrCl < 30 ml/min) gives 250 mg doripenem hver 12. time (se pkt.
English: Doribax dosage adjustment is necessary in patients receiving continuous renal replacement therapy (see section 4.2).
Danish: Det er nødvendigt at justere doseringen af Doribax hos patienter, der får kontinuerlig renal substitutionsterapi (se pkt.
English: Doribax is not likely to affect your ability to drive or operate machinery.
Danish: Det er ikke sandsynligt, at Doribax vil påvirke din evne til at køre bil, motorcykel eller cykle eller til at arbejde med værktøj eller maskiner.
English: What Doribax looks like and contents of the pack Doribax is a white to slightly yellowish off-white crystalline powder in a glass vial.
Danish: Doribax er et hvidt eller let gulligt offwhite krystallinsk pulver i et hætteglas af glas.
English: Based mainly on PK/PD considerations, a 4-hour infusion time may be more suitable to maximize the percentage time during the dosing interval that the plasma concentration of doripenem exceeds the minimum inhibitory concentration (%T > MIC), (see section 5.1).
Danish: Ud fra især farmakokinetiske og farmakodynamiske overvejelser vil en infusionstid på 4 timer muligvis være bedst for at øge den procentdel af doseringsintervallet, hvor doripenems plasmakoncentration overstiger den mindste hæmmende koncentration (%T > MIC) (se pkt.
English: The mean Cmax and AUC0-∞ of doripenem in healthy subjects across studies following administration of 500 mg and 1 g over 4 hours are approximately 8 µg/ml and 17 µg/ml, and 34 µg.h/ml and 68 µg.h/ml, respectively.
Danish: Gennemsnitlig Cmax og AUC0-∞ for doripenem hos raske forsøgspersoner i forskellige studier efter indgift af 500 mg og 1 g over 4 timer er henholdsvis ca. 8 g/ml og 17 g/ml og henholdsvis 34 g x time/ml og 68 g x time/ml.
English: If superinfection occurs, appropriate measures should be taken.
Danish: Der skal tages passende forholdsregler i tilfæde af en superinfektion.
English: The effect of gender on the pharmacokinetics of doripenem was evaluated in healthy male and female subjects.
Danish: Kønnets betydning for doripenems farmakokinetik blev evalueret hos raske forsøgspersoner af begge køn.
English: Time by which reconstitution, dilution and infusion must be completed for Doribax infusion solutions
Danish: Tidsfrister, inden for hvilke rekonstitution, fortynding og infusion skal finde sted for Doribaxinfusionsvæske, opløsning
English: 500 mg doripenem.
Danish: 500 mg
English: However, because of the design of the repeat dose toxicity studies and differences in pharmacokinetics in animals and humans, continuous exposure of animals was not
Danish: Kontinuerlig brug hos dyr blev ikke afdækket i disse studier på grund af studiedesignet for toksicitet efter gentagne doser samt de farmakokinetiske forskelle i dyr og mennesker.
English: There is insufficient information to make dose adjustment recommendations for patients on other
Danish: Der findes ikke tilstrækkelig information til at give anbefalinger om dosisjustering hos patienter i andre former for dialyse (se pkt.
English: This includes medicines you get without a prescription or herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: The exposure to the metabolite doripenem-M-1 in patients on continuous renal replacement therapy may be increased to levels where no in vivo safety data are presently available.
Danish: Hos patienter, der får kontinuerlig renal substitutionsterapi, kan eksponeringen for metabolitten doripenem-M-1 øges til niveauer, hvor der ikke foreligger in vivo-sikkerhedsdata.
English: What Doribax contains - The active substance is doripenem.
Danish: Doribax indeholder: - Aktivt stof: doripenem.
English: Species resistant to other carbapenems do generally express co-resistance to doripenem.
Danish: Generelt udviser stammer, der er resistente over for andre carbapenemer, også resistens for doripenem.
English: White to slightly yellowish off-white crystalline powder
Danish: Hvidt, offwhite eller let gulligt krystallinsk pulver.
English: In patients with moderate renal impairment (CrCl ≥ 30 to  50 ml/min), the dose of doripenem should be 250 mg every 8 hours (see section 6.6).
Danish: Til patienter med moderat nedsat nyrefunktion (CrCl ≥ 30 -  50 ml/min) gives 250 mg doripenem hver 8. time (se pkt.
English: Storage of reconstituted solutions: Upon reconstitution with sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, Doribax suspension in the vial may be held for up to 1 hour below 30C prior to transfer and dilution in the infusion bag.
Danish: Opbevaringstid for rekonstituerede opløsninger: Efter rekonstitution med sterilt vand til injektionsvæsker eller 9 mg/ml (0,9 %) natriumchloridinjektionvæske kan Doribax suspensionen i hætteglasset opbevares i op til 1 time ved temperatur under 30 C før overførsel til og fortynding i infusionsposen.
English: Decreases in valproic acid levels have also been reported when co-administered with other carbapenem agents, achieving a 60-100% decrease in valproic acid levels in about two days.
Danish: Der blev her set fald i niveauet af valproinsyre på 60-100 % på 2 dage.
English: ● Obligation to conduct post-authorisation measures
Danish: ● Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Ikke relevant.
English: OTHER SPECIAL WARNING (S) IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: Anaerobes
Danish: Enterococci
English: Upon reconstitution with sterile water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, Doribax suspension in the vial may be held for up to 1 hour below 30C prior to transfer and dilution in the infusion bag.
Danish: Efter rekonstitution med sterilt vand til injektionsvæsker eller 9 mg/ml natriumchloridinjektionsvæske (0,9 %) kan Doribax-infusionsvæsken i hætteglasset opbevares i op til 1 time ved temperaturer under 30 C før overførsel til og fortynding i infusionsposen.
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ }.
English: Janssen Pharmaceutica NV
Danish: Janssen Pharmaceutica NV Trunhoutseweg 30
English: The following information is intended for healthcare professionals only
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale: Hætteglassene er til engangsbrug.
English: Each vial is for single use only.
Danish: Hætteglassene er til engangsbrug.
English: - probenecid (used to treat gout or high levels of uric acid in the blood).
Danish: (maniodepressiv sygdom), migræne eller skizofreni) - probenecid (bruges til behandling af podagra eller høje koncentrationer af urinsyre i blodet).
English: However, no information is available on the use of either of these
Danish: Der foreligger ingen data.
English: Very common: headache Uncommon: seizures (see section 4.4)
Danish: Meget almindelig: hovedpine Ikke almindelig: kramper (se pkt.
English: Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01DH04.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, carbapenemer.
English: Non species related
Danish: Almindeligvis følsomme arter:
English: Name and address of the manufacturer(s) responsible for batch release Janssen Pharmaceutica NV
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse
English: and Acinetobacter spp.)
Danish: og Acinetobacter spp.)
English: and Acinetobacter spp.).
Danish: og Acinetobacter spp.).