FrancophonIA/ELRC3.0 huggingface dataset:
English: Why is Delstrigo authorised in the EU?
Danish: Hvorfor blev Delstrigo godkendt i EU?
English: What is Delstrigo and what is it used for?
Danish: Hvad er Delstrigo, og hvad anvendes det til?
English: Delstrigo is available as tablets, each containing doravirine 100 mg, lamivudine 300 mg and tenofovir disoproxil 245 mg.
Danish: Delstrigo udleveres som tabletter, der hver indeholder 100 mg doravirin, 300 mg lamivudin og 245 mg tenofovirdisoproxil.
English: The three active substances in Delstrigo, doravirine, lamivudine and tenofovir disoproxil, block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Danish: De tre aktive stoffer i Delstrigo, doravirin, lamivudin og tenofovirdisoproxil, blokerer aktiviteten af revers transkriptase, som er et enzym, der gør det muligt for hivvirusset at formere sig i de celler, det har inficeret.
English: Delstrigo was as effective at keeping HIV infection under control as a similar HIV combination treatment in a main study involving patients with HIV infection who had not been treated before.
Danish: Delstrigo var lige så effektivt til at holde hivinfektion under kontrol som en lignende kombinationsbehandling i et hovedstudie, der omfattede patienter med hivinfektion, som ikke var blevet behandlet tidligere.
English: The medicine is not suitable for patients who are infected with HIV that is resistant to lamivudine, tenofovir disoproxil or to medicines in the same class as doravirine (non-nucleoside reverse transcriptase inhibitors or NNRTIs).
Danish: Lægemidlet er ikke egnet til patienter, der er smittet med hiv, som er resistent over for lamivudin, tenofovirdisoproxil eller lægemidler i samme klasse som doravirin (non-nukleoside reverse transkriptasehæmmere eller NNRTI'er).
English: What are the risks associated with Delstrigo?
Danish: Hvilke risici er der forbundet med Delstrigo?
English: Delstrigo is as effective at keeping HIV infection under control as similar HIV combination treatments.
Danish: Delstrigo er lige så effektivt til at holde hivinfektion under kontrol som lignende hivkombinationsbehandlinger.
English: For the full list of side effects and restrictions with Delstrigo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Delstrigo fremgår af indlægssedlen.
English: Tenofovir disoproxil is a ‘prodrug' of tenofovir, meaning that it is converted in the body to the active substance tenofovir.
Danish: Tenofovirdisoproxil er et såkaldt prodrug (forstadium) til tenofovir, der omdannes til det aktive stof tenofovir i kroppen.
English: Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI).
Danish: Doravirin er en non-nukleosid revers transkriptasehæmmer (NNRTI) og lamivudin er en nukleosid revers transkriptasehæmmer (NRTI).
English: Delstrigo (doravirine / lamivudine / tenofovir disoproxil) EMA/873969/2018
Danish: Delstrigo (doravirin/lamivudin/tenofovirdisoproxil) EMA/661904/2018
English: Delstrigo contains the active substances doravirine, lamivudine and tenofovir disoproxil.
Danish: Delstrigo indeholder de aktive stoffer doravirin, lamivudin og tenofovirdisoproxil.
English: Delstrigo (doravirine / lamivudine / tenofovir disoproxil)
Danish: Delstrigo (doravirin/lamivudin/tenofovirdisoproxil)
English: How is Delstrigo used?
Danish: Hvordan anvendes Delstrigo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Delstrigo have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Delstrigo.
English: What benefits of Delstrigo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Delstrigo?
English: How does Delstrigo work?
Danish: Hvordan virker Delstrigo?
English: (Invented) name Strength Pharmaceutical Form Route of Administration Packaging
Danish: Styrke Lægemiddelform Administration Emballage
English: Your doctor will discuss this with you.
Danish: Deres læge vil diskutere dette med Dem.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} {tlf} {fax} {email}
English: Do not stop using TIENAM until your doctor tells you to.
Danish: Lad være med at stoppe med at bruge TIENAM indtil Deres læge fortæller Dem det.
English: Your doctor has prescribed TIENAM because you have one (or more) of the following types of infection:
Danish: Deres læge har foreskrevet TIENAM, da De har en (eller flere) af følgende typer af infektion:
English: See also above under Central nervous system.
Danish: Se også ovenfor under Centralnervesystemet.
English: • not known: frequency cannot be estimated from the available data
Danish: • Ikke kendte: Frekvensen kan ikke vurderes ud fra forhåndenværende data.
English: PACKAGE LEAFLET: INFORMATION TO THE USER
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
English: Therefore it is unlikely that the suckling infant will be exposed to significant quantities.
Danish: Derfor er det ikke sandsynligt, at det diende spædbarn vil blive eksponeret for signifikante mængder.
English: However, usefulness of this procedure in the overdose setting is unknown.
Danish: Anvendeligheden af denne procedure ved overdosering er dog ukendt.
English: Mechanism of resistance Resistance to imipenem may be due to the following:
Danish: Resistensmekanismer Resistens over for imipenem kan skyldes følgende:
English: Slovenia: CONET
Danish: Slovenien: CONET
English: Small amounts of this medicine may pass into breast milk and it may affect the baby.
Danish: Små mængder af denne medicin kan gå over i mælken og påvirke babyen.
English: CAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.
Danish: ADVARSEL: BLANDINGEN ER IKKE BEREGNET TIL DIREKTE INFUSION.
English: ** EUCAST non-species related breakpoint is used.
Danish: ** EUCAST ikke-arts relateret grænseværdi er anvendt.
English: 1 Proteus and Morganella species are considered poor targets for imipenem.
Danish: 1 Proteus og Morganella species anses for dårlige mål for imipenem.
English: Do not use TIENAM after the expiry date stated on the container.
Danish: Brug ikke TIENAM efter den udløbsdato, der står på pakningen.
English: Do not take a double dose to make up for a forgotten dose.
Danish: De må ikke få en dobbeltdosis som erstatning for en glemt dosis.
English: Like all medicines, TIENAM can cause side effects, although not everybody gets them.
Danish: TIENAM kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Intravenous use after reconstitution.
Danish: Intravenøs anvendelse efter rekonstituering.
English: Italy: TIENAM (20 ml), IMIPEM (20 ml) and TENACID (20 ml) Latvia: TIENAM I.V.
Danish: Italien: TIENAM (20 ml), IMIPEM (20 ml) and TENACID (20 ml) Letland: TIENAM I.V.
English: You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells.
Danish: De kan udvikle en positiv test (Coombs test), der viser tilstedeværelse af antistoffer, der kan ødelægge de røde blodceller.
English: No specific information is available on treatment of overdose with TIENAM.
Danish: Der er ingen specifik information om behandling af overdoseing med TIENAM.
English: Actual body weight (kg) X standard dose 70 (kg)
Danish: aktuel legemsvægt (kg) x standarddosis 70 (kg)
English: • Pain in several joints, weakness
Danish: • Smerter i adskillige led, svaghed
English: Long term studies in animals have not been performed to evaluate carcinogenic potential of imipenemcilastatin.
Danish: Der er ikke udført langtidsstudier hos dyr til vurdering af det karcinogene potentiale for imipenemcilastatin.
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory.
Danish: Identifikation af og antimikrobielle følsomhedstest på sådanne isolater skal gentages, og hvis resultatet bekræftes, skal isolatet sendes til et referencelaboratorium.
English: Your doctor will decide whether you should use TIENAM in combination with these medicines.
Danish: Deres læge vil beslutte, om De kan bruge TIENAM i kombination med disse lægemidler.
English: Important information about some of the ingredients of TIENAM
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i TIENAM
English: The maximum total daily dose should not exceed 4000 mg/4000 mg per day.
Danish: Maksimal, total daglig dosis bør ikke overstige 4.000 mg/4.000 mg.
English: 4 Strains with MIC values above the susceptible breakpoint are very rare or not yet reported.
Danish: 4 Stammer med MIC-værdier over den følsomme grænseværdi er meget sjældne eller endnu ikke rapporteret.
English: Variations of colour, from colourless to yellow, do not affect the potency of the product.
Danish: Farvevariationer, fra farveløs til gul, påvirker ikke præparatets virkning.
English: Meningitis TIENAM is not recommended for the therapy of meningitis.
Danish: Meningitis TIENAM anbefales ikke til behandling af meningitis.
English: SPECIAL STORAGE CONDITIONS Do not store above 25C After reconstitution: Diluted solutions should be used immediately.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25°C Efter rekonstituering: Fortyndede opløsninger skal anvendes straks.
English: Diluted solutions should be used immediately.
Danish: Fortyndede opløsninger skal anvendes straks.
English: Tell your doctor if you are taking ganciclovir which is used to treat some viral infections.
Danish: Fortæl Deres læge, hvis De tager ganciclovir, der bruges til behandling af visse virusinfektioner.
English: • Neisseria gonorrhoeae: There is insufficient evidence that Neisseria gonorrhoeae is a good target for therapy with imipenem.
Danish: • Neisseria gonorrhoeae: Der er utilstrækkelig evidens for, at Neisseria gonorrhoeae er et godt mål for behandling med imipenem.
English: The following adverse reactions have been reported in clinical studies or during post-marketing experience.
Danish: Følgende bivirkninger er set i kliniske studier eller efter markedsføring.
English: TIENAM belongs to a group of medicines called carbapenem antibiotics.
Danish: TIENEM tilhører en medicingruppe kaldet carbapenem-antibiotika.
English: They are for use only for species not mentioned in the overview of species-related breakpoints or footnotes.
Danish: De er kun til brug til arter, der ikke er nævnt i oversigten over arts-relaterede grænseværdier eller fodnoter.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: De officielle retningslinjerfor hensigtsmæssig anvendelse af antibiotika skal tages i betragtning.
English: Nausea and vomiting appear to occur more frequently in patients with low number of white blood cells
Danish: Kvalme og opkastning synes at forekomme oftere hos patienter med lavt antal hvide blodceller
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: Bemærk: Dette produktresumé, denne etikettering og denne indlægsseddel er den udgave, som er gyldig på tidspunktet for Kommissionens afgørelse.
English: Plasma concentrations
Danish: Plasmakoncentration
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Prævalensen af erhvervet resistens kan variere geografisk og med tiden for udvalgte arter, og lokal information om resistens er ønskelig, især ved behandling af alvorlige infektioner.
English: TIENAM has not been studied in pregnant women.
Danish: TIENAM er ikke undersøgt hos gravide.
English: The total daily dose (i.e. 2000/2000, 3000/3000 or 4000/4000 mg) that would usually be applicable to patients with normal renal function should be selected.
Danish: Den totale daglige dosis (dvs. 2.000/2.000, 3.000/3.000 eller 4.000/4.000 mg), som normalt vil være gældende for patienter med normal nyrefunktion, vælges.
English: It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving TIENAM.
Danish: Det er vigtigt, at De fortæller Deres læge, hvis De er gravid eller planlægger at blive gravid, før De bruger TIENAM.
English: The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalised ratio) is difficult to assess.
Danish: Risikoen kan variere med den underliggende infektion samt patientens alder og generelle status, hvorfor antibiotikummets bidrag til stigningen i INR (international normalised ratio) er vanskelig at vurdere.
English: Activity of dehydropeptidase-I in the kidney returned to normal levels shortly after the elimination of cilastatin from the blood stream.
Danish: Aktiviteten af dehydropeptidase-I i nyrerne vendte tilbage til normalt niveau kort efter elimination af cilastatin fra blodbanen.
English: The proportionate dose for patients < 70 kg would be calculated using the following formula:
Danish: Den proportionelle dosis til patienter <70 kg kan beregnes ved brug af følgende formel:
English: Paediatric population <1 year of age Clinical data are insufficient to recommend dosing for children less than 1 year of age
Danish: Pædiatrisk population <1 år Kliniske data er utilstrækkelige til at anbefale dosering til børn under 1 år.
English: Total daily dose for patients with normal renal function (mg/day)
Danish: Total daglig dosis til patienter med normal nyrefunktion (mg/dag)
English: • Ringing in the ears (tinnitus)
Danish: • Ringen for ørene (tinnitus)
English: • severe pneumonia including hospital and ventilator-associated pneumonia
Danish: • svær pneumoni inklusive hospitals- og ventilatorassocieret pneumoni
English: 6.6 Special precautions for disposal and other handling Each vial is for single use only.
Danish: 6.6 Regler for destruktion og anden håndtering Hvert hætteglas er kun til engangsbrug.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne præsenteret efter faldende alvorlighed.
English: EUCAST MIC breakpoints for imipenem to separate susceptible (S) pathogens from resistant (R) pathogens are as follows (v 1,1 2010-04-27):
Danish: EUCAST MIC grænseværdier for imipenem til separate følsomme (F) patogener fra resistente (R) patogener er følgende (v 1,1 2010-04-27):
English: Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
Danish: Indtil der er evidens for klinisk respons for bekræftede isolater med MIC over den aktuelle resistente grænseværdi, skal de rapporteres som resistente.
English: In patients who develop nausea during the infusion, the rate of infusion may be slowed.
Danish: Hos patienter, der får kvalme under infusionen, kan infusionshastigheden nedsættes.
English: 2 The breakpoints for Pseudomonas relate to high dose frequent therapy (1g every 6 hours).
Danish: 2 Grænseværdier for Pseudomonas relaterer til hyppig højdosis-behandling (1 g hver 6. time).
English: From table 1 the appropriate reduced dose regimen is selected according to the patient's creatinine clearance.
Danish: Det relevante reducerede dosisregime vælges fra tabel 1 i overensstemmelse med patientens kreatinin-clearance.
English: Paediatric (≥3 months of age)
Danish: Børn (≥3 måneder)
English: Little absorption of either compound occurs following oral administration.
Danish: Kun en lille del af de to stoffer absorberes efter oral administration.
English: The resulting mixture should be agitated until clear.
Danish: Blandingen skal rystes, til den er klar.
English: • Reduced affinity of PBPs to imipenem
Danish: • Reduceret affinitet af PBPer for imipenem
English: Serious anaphylactic reactions require immediate emergency treatment.
Danish: Alvorlige anafylaktiske reaktioner kræver omgående behandling.
English: there may be an increased risk of seizures.
Danish: kan der være øget risiko for krampeanfald.
English: The frequency of possible side effects listed below is defined using the following convention:
Danish: Frekvensen af bivirkningerne, som er nævnt nedenfor, er defineret på følgende måde:
English: Discontinuation of therapy with imipenem/cilastatin and the administration of specific treatment for Clostridium difficile should be considered.
Danish: Seponering af behandling med imipenem/cilasatin og administration af specifik behandling for Clostridium difficile bør overvejes.
English: Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects.
Danish: Samtidig administration af antibiotika og warfarin kan forstærke den antikoagulerende virkning.
English: • Fungal infection (candidiasis)
Danish: • Svampeinfektion (candidiasis)
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke udført studier på evnen til at føre motorkøretøj og betjene maskiner.
English: Uncommon psychic disturbances including hallucinations and confusional states
Danish: Ikke almindelig Psykiske forstyrrelser inklusive hallucinationer og konfusion
English: All adverse reactions are listed under system organ class and frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Alle bivirkninger er listet under systemorganklasse og frekvens: Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke almindelig (≥1/1.000 til <1/100), Sjælden (≥1/10.000 til <1/1.000), Meget sjælden (<1/10.000); ikke kendt (kan ikke estimeress ud fra forhåndenværende data).
English: It is devoid of intrinsic antibacterial activity and does not affect the antibacterial activity of imipenem.
Danish: Det har ingen selvstændig antibakteriel aktivitet og påvirker ikke imipenems antibakterielle aktivitet.
English: In studies of 178 paediatric patients ≥3 months of age, the reported adverse reactions were consistent with those reported for adults.
Danish: I studier med 178 pædiatriske patienter i alderen ≥3 måneder var de rapporterede bivirkninger de samme som for voksne.
English: If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted.
Danish: Hvis der opstår fokal tremor, myoklonier eller krampeanfald, bør patienten evalueres neurologisk og sættes i antikonvulsiv behandling, hvis dette ikke allerede er institueret.
English: Pregnancy There are no adequate and well-controlled studies for the use of imipenem/cilastatin in pregnant women.
Danish: Der er ingen tilstrækkelige eller velkontrollerede studier vedrørende anvendelse af imipenem/cilastatin til gravide kvinder.
English: Generalized seizures have been reported in patients who received ganciclovir and TIENAM.
Danish: Generaliserede krampeanfald er set hos patienter, som blev behandlet med ganciclovir og TIENAM.
English: Distribution The binding of imipenem to human serum proteins is approximately 20%.
Danish: Fordeling Imipenems binding til humant serumprotein er ca. 20%.
English: Pharmacotherapeutic group: Antibacterials for systemic use, carbapenems, ATC code: J01D H51
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, carbapenemer, ATC-kode: J01DH51
English: 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.
Danish: 5 Ikke-arts relaterede grænseværdier er hovedsageligt bestemt på basis of farmakokinetiske/ farmakodynamiske data og er uafhængigt af MIC-distributionen for specifikke arter.
English: The urinary recovery of active (non-metabolized) imipenem decreased to approximately 60% of the dose when TIENAM was administered with probenecid.
Danish: Genfinding af aktiv (ikke-metaboliseret) imipenem i urinen faldt til ca. 60% af dosis, når TIENAM blev administreret sammen med probenecid.
English: Available evidence suggests that cilastatin prevents the nephrotoxicity by preventing entry of imipenem into the tubular cells.
Danish: Tilgængelig dokumentation tyder på, at cilastatin forebygger nefrotoksicitet ved at hindre, at imipenem trænger ind i de tubulære celler.
English: The concentration of the reconstituted solution following the above procedure is approximately 5 mg/ml for both imipenem and cilastatin.
Danish: Koncentrationen af den rekonstituerede opløsning er efter ovenstående procedure ca. 5 mg/ml for både imipenem og cilastatin.
English: • Decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins)
Danish: • Nedsat permeabilitet af de gram-negative bakteriers ydre membran (på grund af nedsat produktion af poriner)
English: • Increase in some white blood cells
Danish: • Stigning i antallet af nogle hvide blodceller
English: If CNS symptoms continue, the dose of TIENAM should be decreased or discontinued.
Danish: Hvis CNS-symptomerne fortsætter, skal TIENAM-dosis nedsættes eller behandlingen seponeres.
English: • Seeing, hearing or feeling something that is not there (hallucinations)
Danish: • Hallucinationer (se, høre eller føle ting som i virkeligheden ikke er der
English: • Psychic disturbances (such as mood swings and impaired judgment)
Danish: • Psykiske forstyrrelser (såsom humørsvingninger og svækket dømmekraft)
English: Non-clinical data reveal no special hazard for humans based on repeated dose toxicity and genotoxicity studies.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra toksicitet efter gentagne doser og genotoksicitet.
English: These medicinal products should not be used concomitantly unless the potential benefit outweighs the risks.
Danish: Disse lægemidler bør ikke bruges sammen, medmindre de potentielle fordele opvejer risikoen.
English: It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent.
Danish: Det anbefales, at INR monitoreres hyppigt under og kort efter administration af antibiotika til patienter i behandling med orale antikoagulantia.
English: 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.
Danish: 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.
English: • Nausea, vomiting, diarrhoea.
Danish: • Kvalme, opkastning, diarré.
English: Germany: ZIENAM
Danish: Tyskland: ZIENAM
English: • Allergic reactions including rash, swelling of the face, lips, tongue and/or throat (with difficulty in breathing or swallowing), and/or low blood pressure.
Danish: • Allergiske reaktioner inklusive udslæt, hævelse af ansigt, læber, tunge og/eller hals (med åndedræts eller synkebesvær) og/eller lavt blodtryk.
English: 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.
Danish: 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.