FrancophonIA/ELRC3.0 huggingface dataset:
English: • Itching all over the body
Danish: • Kløe over hele kroppen
English: This medicine should not be used in children and adolescents as it has not been studied enough in these populations.
Danish: Dette lægemiddel må ikke bruges til børn og unge, da det ikke er undersøgt tilstrækkeligt hos disse grupper.
English: The eGFR was calculated using the MDRD4 equation.
Danish: eGFR blev beregnet ved hjælp af MDRD4-ligningen.
English: The tablets are swallowed whole and can be taken with or without food or drink.
Danish: Tabletterne synkes hele og kan tages med eller uden mad og drikke.
English: Talk to a doctor if you do not feel better, or if you feel worse after 6 days.
Danish: Kontakt lægen, hvis du ikke får det bedre, eller hvis du får det værre efter 6 dage.
English: The clinical relevance of this finding is unknown.
Danish: Den kliniske relevans af dette fund er ikke kendt.
English: The clinical experience in patients ≥75 years is limited.
Danish: Der er begrænset klinisk erfaring hos patienter ≥75 år.
English: A risk to the breast-feeding infant cannot be excluded.
Danish: En risiko for ammede spædbørn kan ikke udelukkes.
English: If a rapid antibiotic effect is needed, the intravenous administration should be considered.
Danish: Ved behov for hurtig antibiotisk virkning bør intravenøs administration overvejes.
English: It works by stopping the growth of certain bacteria which can cause serious infections.
Danish: Det virker ved at standse væksten af bestemte bakterier, der kan give alvorlige infektioner.
English: Resistance to antibiotics
Danish: Resistens over for antibiotika
English: Patients with neutropenia
Danish: Patienter med neutropeni
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: You should take all 6 tablets to complete your course of treatment, even if you have missed a dose.
Danish: Du skal tage alle 6 tabletter for at gennemføre hele behandlingsforløbet, også hvis du har glemt en dosis.
English: Non-susceptible microorganisms
Danish: Ikke-følsomme mikroorganismer
English: No clinically relevant interactions are expected to occur with these transporters, with the exception of BCRP.
Danish: Der forventes ingen relevante interaktioner med disse transportører bortset fra BCRP.
English: It must not be administered as an intravenous bolus.
Danish: Den må ikke administreres som intravenøs bolus.
English: The bag should not be shaken.
Danish: Posen må ikke omrystes.
English: If you stop taking Sivextro without the advice of your doctor, your symptoms may get worse.
Danish: Hvis du holder op med at tage Sivextro uden at rådføre dig med lægen, kan dine symptomer blive værre.
English: Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Danish: Grænseværdierne for den mindste hæmmende koncentration (MIC), fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST), er følgende:
English: Patients who commence treatment on the parenteral formulation may be switched to the oral presentation when clinically indicated.
Danish: Patienter, hvis behandling starter med den parenterale formulering, kan skifte til den orale formulering, når det er klinisk indiceret.
English: Adverse reactions are classified by preferred term and System Organ Class, and by frequency.
Danish: Bivirkningerne er anført i henhold til foretrukken term, systemorganklasse og hyppighed.
English: Sivextro must not be mixed with other medicinal products.
Danish: Sivextro må ikke blandes med andre lægemidler.
English: The average binding of tedizolid to human plasma proteins is approximately 70-90%.
Danish: Tedizolids gennemsnitlige binding til humane plasmaproteiner er ca. 70-90 %.
English: • Streptococcus anginosus group (including S. anginosus, S. intermedius and S. constellatus)
Danish: • Streptococcus anginosus-gruppen (herunder S. anginosus, S. intermedius og S. constellatus)
English: Only the pharmacokinetic profile of tedizolid is discussed in this section.
Danish: Det er kun tedizolids farmakokinetiske profil, der diskuteres i dette afsnit.
English: Other than tedizolid, which accounts for approximately 95% of the total radiocarbon AUC in plasma, there are no other significant circulating metabolites.
Danish: Bortset fra tedizolid, der tegner sig for ca. 95 % af den totale kulstof 14-AUC i plasma, er der ingen andre signifikante cirkulerende metabolitter.
English: Contact your doctor straight away if you suffer from diarrhoea during or after your treatment.
Danish: Kontakt lægen med det samme, hvis du får diarré under eller efter behandlingen.
English: Ask your doctor for advice before breast-feeding your baby.
Danish: Spørg din læge til råds, før du ammer dit barn.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodiumfree.”
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Danish: Det er vigtigt at gennemgå sygehistorien omhyggeligt, da CDAD er blevet rapporteret mere end to måneder efter administration af antibakterielle midler.
English: CDAD must be considered in all patients who present with severe diarrhoea following antibiotic use.
Danish: CDAD skal overvejes som en mulighed hos alle patienter, der får svær diarré efter brug af antibiotika.
English: This is when antibiotics cannot stop the growth of bacteria and treat your infection.
Danish: Det vil sige, at antibiotika ikke kan standse bakteriernes vækst og behandle infektionen.
English: See Other medicines and Sivextro for examples.
Danish: Se Brug af anden medicin sammen med Sivextro for eksempler.
English: Other types of skin infections have not been studied.
Danish: Andre typer hudinfektioner er ikke undersøgt.
English: Medicinal products inhibiting peristalsis are contraindicated in this situation.
Danish: Lægemidler, der hæmmer peristaltikken, er kontraindicerede i denne situation.
English: It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.
Danish: Det sker gennem et drop direkte ind i en blodåre (intravenøst) i løbet af ca. 1 time.
English: Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials, ATC code: J01XX11
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, andre antibakterika, ATC-kode: J01XX11
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Danish: Polyvinylalkohol Titandioxid (E171) Macrogol
English: Appropriate supportive measures, antibiotic treatment of C. difficile, and surgical evaluation should be considered.
Danish: Understøttende behandling, antibiotisk behandling af C. difficile og kirurgisk evaluering skal overvejes.
English: Bacteria can become resistant to treatment with antibiotics over time.
Danish: Bakterier kan med tiden blive resistente over for antibiotika.
English: Do not use Lactated Ringer's Injection or Hartmann's Solution.
Danish: Brug ikke Ringers lactat eller Hartmann.
English: Warnings and precautions Your doctor will have decided if Sivextro is suitable to treat your infection.
Danish: Advarsler og forsigtighedsregler Din læge vil tage stilling til, om Sivextro er egnet til at behandle din infektion.
English: Tedizolid demonstrated linear pharmacokinetics with regard to dose and time.
Danish: Tedizolid udviste lineær farmakokinetik, hvad angår dosis og tid.
English: Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.
Danish: Behandling med antibakterielle midler ændrer tarmens normale flora og kan medføre kraftig vækst af C. difficile.
English: Tedizolid is eliminated in excreta, primarily as a non-circulating sulfate conjugate.
Danish: Tedizolid elimineres ved ekskretion, fortrinsvis som et ikke-cirkulerende sulfatkonjugat.
English: Tedizolid, generated from tedizolid phosphate after metabolic activation (in vitro and in vivo), was also tested for genotoxicity.
Danish: Tedizolid, genereret af tedizolidphosphat efter metabolisk aktivering (in vitro og in vivo), blev også testet for genotoksicitet.
English: Any unused medicine or waste material, including materials used for reconstitution, dilution and administration, should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf, herunder materialer til rekonstitution, fortynding og administration, skal bortskaffes i henhold til lokale retningslinjer.
English: Organisms
Danish: Organismer
English: In the event of overdose, Sivextro should be discontinued and general supportive treatment given.
Danish: Ved overdosering skal Sivextro seponeres, og der skal gives almindelig understøttende behandling.
English: Controlled clinical studies did not include patients with neutropenia (neutrophil counts <1,000 cells/mm
Danish: De kontrollerede kliniske studier omfattede ikke patienter med neutropeni (neutrofiltal <1.000 celler/mm
English: Clostridioides difficile associated diarrhoea
Danish: Clostridioides difficile-associeret diarré
English: Administration of Sivextro with tyramine-rich foods (i.e., containing tyramine levels of approximately 100 mg) would not be expected to elicit a pressor response.
Danish: Administration af Sivextro sammen med fødevarer, der indeholder meget tyramin (dvs. omkring 100 mg tyramin), forventes ikke at udløse pressor-respons.
English: All patients should be advised to report symptoms of visual impairment, such as changes in visual acuity, changes in colour vision, blurred vision, or visual field defect.
Danish: Alle patienter skal informeres om at rapportere symptomer på nedsat syn, f.eks. ændret synsskarphed, ændret farveopfattelse, sløret syn eller synsfeltdefekt.
English: The absolute bioavailability of tedizolid is above 90%.
Danish: Tedizolid har en absolut biotilgængelighed på over 90 %.
English: Sivextro can interfere with the effects of these medicines.
Danish: Sivextro kan have indvirkning på disse lægemidlers effekt.
English: The safety and efficacy of tedizolid phosphate in children and adolescents below 18 years of age have not yet been established.
Danish: Tedizolidphosphats sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Membrane transporters
Danish: Membrantransportproteiner
English: Hyperhidrosis Pruritus
Danish: Hyperhidrose Pruritus
English: The highest single dose administered in clinical studies was 1,200 mg. All adverse reactions at this dose level were mild or moderate in severity.
Danish: Den højeste enkeltdosis, der blev administreret i de kliniske studier, var 1.200 mg. Alle bivirkninger ved denne dosis var af let eller moderat sværhedsgrad.
English: The elimination half-life of tedizolid is approximately 12 hours and the intravenous clearance is 6-7 L/h.
Danish: Tedizolids eliminationshalveringstid er ca. 12 timer, og den intravenøse clearance er 6-7 l/time.
English: This study used sensitive morphologic evaluation of perfusion-fixed peripheral and central nervous system tissue.
Danish: I studiet blev der udført en sensitiv morfologisk evaluering af perfusionsfikseret væv fra det perifere nervesystem og centralnervesystemet.
English: Peel, then push
Danish: Riv af og tryk derefter
English: Adverse reactions such as lactic acidosis, anaemia and neuropathy (optic and peripheral) may occur as a result of this inhibition.
Danish: Bivirkninger som laktatacidose, anæmi og neuropati (optisk og perifer) kan forekomme som resultat af denne hæmning.
English: Driving and using machines Do not drive or use machines if you feel dizzy or tired after taking this medicine.
Danish: Du må ikke køre bil eller betjene maskiner, hvis du føler dig svimmel eller træt efter at have taget dette lægemiddel.
English: Sivextro will be given to you by a nurse or doctor.
Danish: Du får Sivextro af en sygeplejerske eller en læge.
English: The safety profile in this study was similar to the Phase 3 clinical trials; however, infusion site reactions (phlebitis) were reported more frequently (2.7%) in tedizolid phosphate treated subjects than in the linezolid control group (0%), particularly among Asian patients.
Danish: Sikkerhedsprofilen i dette studie var sammenlignelig med kliniske fase 3-studier; reaktioner på infusionsstedet (flebitis) blev dog rapporteret hyppigere (2,7 %) hos tedizolidphosphat-behandlede forsøgspersoner end i linezolid-kontrolgruppen (0 %), især blandt asiatiske patienter.
English: If CDAD is suspected or confirmed, tedizolid phosphate and, if possible, other antibacterial agents not directed against C. difficile should be discontinued and adequate therapeutic measures should be initiated immediately.
Danish: Ved mistanke om CDAD eller hvis mistanken bekræftes, skal tedizolidphosphat og, om muligt, andre antibakterielle midler, der ikke er rettet mod C. difficile, seponeres, og der skal omgående iværksættes relevant behandling.
English: Frequencies are defined as: 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).
Danish: Hyppigheden defineres som følger: 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) og meget sjælden (<1/10.000).
English: Only limited data are available on the compatibility of Sivextro with other intravenous substances, therefore additives or other medicinal products should not be added to Sivextro single use vials or infused simultaneously.
Danish: Der er kun begrænsede data om Sivextros kompatibilitet med andre intravenøse stoffer, og derfor må additiver eller andre lægemidler ikke tilsættes engangshætteglassene med Sivextro eller infunderes samtidig med Sivextro.
English: There are no data from the use of tedizolid phosphate in pregnant women.
Danish: Der er ingen data fra anvendelse af tedizolidphosphat til gravide kvinder.
English: If not, the reconstituted and diluted solution should be stored at room temperature or in a refrigerator at 2°C to 8°C, and administered within 24 hours after reconstitution.
Danish: Hvis den rekonstituerede og fortyndede opløsning ikke bruges med det samme, skal opløsningen opbevares ved stuetemperatur eller i køleskab ved 2-8 °C og administreres inden for 24 timer efter rekonstitution.
English: Sivextro is administered intravenously over approximately 1 hour.
Danish: Sivextro skal administreres intravenøst over ca. 1 time.
English: • topotecan (used to treat cancer)
Danish: • topotecan (til behandling af kræft)
English: Pruritus Generalised
Danish: Generaliseret pruritus
English: Ask your doctor or pharmacist if you are not sure whether you are taking any of these medicines.
Danish: Spørg din læge eller apotekspersonalet, hvis du ikke er sikker på, om du tager denne type medicin.
English: - are allergic to other medicines belonging to the group “oxazolidinones” (e.g., linezolid, cycloserine).
Danish: - hvis du er allergisk over for andre lægemidler, der tilhører oxazolidinon-gruppen (f.eks. linezolid eller cycloserin).
English: Your doctor will decide if you should be given Sivextro to treat your infection.
Danish: Din læge vurderer, om du skal have Sivextro til behandling af din infektion.
English: Acute bacterial skin and skin structure infections
Danish: Akutte bakterieinfektioner i hud og hudstrukturer
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6
Danish: For instruktioner om rekonstitution og fortynding af lægemidlet før administration, se pkt.
English: Less than 3% of tedizolid phosphate administered dose is excreted as active tedizolid.
Danish: Under 3 % af den administrerede dosis tedizolidphosphat udskilles som aktivt tedizolid.
English: • Poor control of diabetes
Danish: • Dårlig regulering af sukkersyge (diabetes)
English: In cases where tedizolid phosphate was discontinued, the affected haematological parameters have returned back to pre-treatment levels.
Danish: I de tilfælde, hvor tedizolidphosphat blev seponeret, vendte disse hæmatologiske parametre tilbage til niveauerne før behandlingen.
English: Once opened this medicine must be used immediately.
Danish: Når hætteglasset er åbnet, skal indholdet bruges med det samme.
English: Antibacterial activity against other relevant pathogens
Danish: Antibakteriel aktivitet mod andre relevante patogener
English: Talk to your doctor or nurse before taking Sivextro if any of the following apply to you: - are suffering from diarrhoea, or have suffered from diarrhoea whilst (or up to 2 months after) taking antibiotics in the past.
Danish: Kontakt lægen eller sundhedspersonalet, før du tager Sivextro, hvis noget af nedenstående gælder for dig: - hvis du har diarré, eller hvis du tidligere har fået diarré, når du har taget antibiotika (eller op til 2 måneder efter, at du har fået antibiotika).
English: CDAD may range in severity from mild diarrhoea to fatal colitis.
Danish: CDAD kan variere i sværhedsgrad fra let diarré til dødelig colitis.
English: Sivextro must be administered by intravenous infusion over a 60-minute period.
Danish: Sivextro skal administreres som intravenøs infusion over 60 minutter.
English: • Abnormal smelling urine, abnormal blood tests
Danish: • Unormal urinlugt, unormale blodprøver
English: Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Danish: Du må ikke tage medicin mod diarré, før du har talt med lægen.
English: The impact of gender on the pharmacokinetics of tedizolid phosphate was evaluated in healthy males and females in clinical studies and in a population pharmacokinetics analysis.
Danish: Kønnets betydning for tedizolidphosphats farmakokinetik blev evalueret hos raske mænd og kvinder i kliniske studier og i en farmakokinetisk populationsanalyse.
English: Long-term carcinogenicity studies have not been conducted with tedizolid phosphate.
Danish: Der er ikke udført langvarige karcinogenicitetsstudier med tedizolidphosphat.
English: Due to a hydroxymethyl group in the C5 position, tedizolid retains activity against strains of Staphylococcus aureus that express the cfr gene in the absence of chromosomal mutations.
Danish: På grund af en hydroxymethyl-gruppe i C5-positionen bibeholder tedizolid aktivitet mod Staphylococcus aureus-stammer, der udtrykker cfr-genet, hvis der ikke er kromosomale mutationer.
English: Pharmacokinetic studies were conducted in healthy volunteers and population pharmacokinetic analyses were conducted in patients from Phase 3 studies.
Danish: Der er udført farmakokinetiske studier med raske forsøgspersoner, og der er udført farmakokinetiske populationsanalyser hos patienter fra fase 3-studier.
English: These findings suggest a higher frequency of infusion related reactions (phlebitis) than was observed in previous clinical studies with tedizolid phosphate.
Danish: Disse resultater tyder på en højere hyppighed af infusionsrelaterede reaktioner (flebitis) end der blev observeret i tidligere kliniske studier med tedizolidphosphat.
English: No meaningful changes in blood pressure or heart rate were seen with pseudoephedrine.
Danish: Der sås ingen nævneværdige ændringer i blodtryk eller hjertefrekvens for pseudoephedrin.
English: You will be given one 200 mg infusion of Sivextro once a day for 6 days.
Danish: Du får en infusion med 200 mg Sivextro en gang om dagen i 6 dage.
English: Aseptic technique must be followed when preparing the infusion solution.
Danish: Der skal anvendes aseptisk teknik, når infusionsvæsken tilberedes.
English: Myelosuppression (including anaemia, leucopenia, pancytopenia and thrombocytopenia) has been reported in patients treated with another member of the oxazolidinone class and the risk of these effects appeared to be related to the duration of treatment.
Danish: Myelosuppression (herunder anæmi, leukopeni, pancytopeni og trombocytopeni) er rapporteret hos patienter, der blev behandlet med et andet antibiotikum i oxazolidinon-klassen, og risikoen for at få disse bivirkninger synes at være relateret til behandlingsvarigheden.
English: Talk to your doctor or pharmacist before you stop taking your medicine.
Danish: Kontakt lægen eller apotekspersonalet, før du holder op med at tage dette lægemiddel.
English: Potential serotonergic interactions
Danish: Mulige serotonerge interaktioner
English: Sivextro may have a minor influence on the ability to drive and use machines as it may cause dizziness, fatigue or, uncommonly, somnolence (see section 4.8).
Danish: Sivextro kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner, da det kan forårsage svimmelhed og træthed eller i nogle tilfælde døsighed (se pkt.
English: A special neuropathology study was conducted in pigmented Long Evans rats administered tedizolid phosphate daily for up to 9 months.
Danish: Der er udført et særligt neuropatologisk studie hos pigmenterede Long Evans-rotter, der fik tedizolidphosphat dagligt i op til 9 måneder.
English: The effects of tedizolid phosphate on fertility in humans have not been studied.
Danish: Tedizolidphosphats indvirkning på fertiliteten hos mennesker er ikke undersøgt.
English: The recommended dose is one 200 mg tablet once a day for 6 days.
Danish: Den anbefalede dosis er en 200 mg tablet en gang dagligt i 6 dage.
English: Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to tedizolid in the absence of acquired mechanisms of resistance:
Danish: Den kliniske virkning mod nedenstående patogener er ikke klarlagt, men in vitro-studier tyder på, at disse patogener vil være følsomme for tedizolid ved fravær af erhvervede resistensmekanismer:
English: Tell your doctor straight away if you suffer from any of the following while taking Sivextro:
Danish: Fortæl det straks til lægen, hvis en eller flere af nedenstående tilstande gælder for dig, mens du tager Sivextro:
English: The AUC/MIC ratio was the pharmacodynamic parameter shown to best correlate with efficacy in mouse thigh and lung S. aureus infection models.
Danish: AUC/MIC-ratioen var den farmakodynamiske parameter, der korrelerede bedst med effekten i S. aureus-infektionsmodeller i muselår og muselunger.
English: The AUC/MIC ratio to achieve bacteriostasis in neutropenic mice was at least 16 times that in immunocompetent animals (see section 4.4).
Danish: AUC/MIC-ratioen for opnåelse af bakteriostase var mindst 16 gange større hos mus med neutropeni end hos immunkompetente dyr (se pkt.
English: Safety was additionally evaluated in a randomized, double-blind, multicenter study conducted in China, the Philippines, Taiwan, and the US, which included a total 292 adult patients treated with tedizolid phosphate 200 mg administered IV and/or oral once daily for 6 days, and 297 patients treated with linezolid 600 mg administered IV and/or oral every 12 hours for 10 days for ABSSSI.
Danish: Sikkerheden blev yderligere vurderet i et randomiseret, dobbeltblindet multicenterstudie, der blev udført i Kina, Filippinerne, Taiwan og USA, som inkluderede i alt 292 voksne patienter, som blev behandlet med tedizolidphosphat 200 mg administreret intravenøst og/eller oralt en gang dagligt i 6 dage, og 297 patienter, som blev behandlet med linezolid 600 mg administreret intravenøst og/eller oralt hver 12. time i 10 dage for ABSSSI.