FrancophonIA/ELRC3.0 huggingface dataset:
English: C-labeled tedizolid phosphate under fasted conditions, the majority of elimination occurred via the liver with 81.5% of the radioactive dose recovered in faeces and 18% in urine, with most of the elimination (>85%) occurring within 96 hours.
Danish: C-mærket tedizolidphosphat under faste skete størstedelen af eliminationen via leveren, idet 81,5 % af den radioaktive dosis blev udskilt i fæces og 18 % i urinen.
English: Gastrooesophageal reflux disease
Danish: Gastroøsofageal reflukssygdom Hæmatokeksi
English: The potential for tedizolid or tedizolid phosphate to inhibit transport of probe substrates of important drug uptake (OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2) and efflux transporters (P-gp and BCRP) was tested in vitro.
Danish: Tedizolids eller tedizolidphosphats mulighed for at hæmme transporten af probe-substrater for vigtige transportører af optagelse (OAT1, OAT3, OATP1B1, OATP1B3, OCT1 og OCT2) og effluks (P-gp og BCRP) blev testet in vitro.
English: These effects occurred at plasma tedizolid exposure levels (AUC) ≥3-fold greater than the expected human plasma exposure associated with the therapeutic dose.
Danish: Disse virkninger sås ved tedizolid-plasmaeksponeringer (AUC), der var ≥3 gange højere end den forventede humane plasmaeksponering ved den terapeutiske dosis.
English: Effects of other medicines on Sivextro
Danish: Andre lægemidlers virkning på Sivextro
English: • anaemia (low red blood cells)
Danish: • blodmangel (lavt antal røde blodlegemer; også kaldet anæmi)
English: Table 1 Frequency of adverse reactions by System Organ Class in comparative clinical studies
Danish: Tabel 1 Hyppighed af bivirkninger i sammenlignende kliniske studier (efter systemorganklasse)
English: Sivextro is incompatible with any solutions containing divalent cations (e.g., Ca
Danish: Sivextro er uforligeligt med alle infusionsvæsker, der indeholder divalente kationer (f.eks.
English: This effect is not clinically meaningful, and no dose adjustment for co-administered CYP3A4 substrates is necessary during tedizolid phosphate treatment.
Danish: Denne virkning er ikke klinisk relevant, og dosisjustering er ikke nødvendig for samtidigt administrerede CYP3A4-substrater under behandling med tedizolidphosphat.
English: The pharmacokinetics of tedizolid in elderly healthy volunteers (age 65 years and older, with at least 5 subjects at least 75 years old; n=14) was comparable to younger control subjects (25 to 45 years old; n=14) following administration of a single oral dose of tedizolid phosphate 200 mg.
Danish: Tedizolids farmakokinetik hos ældre raske forsøgspersoner (i alderen 65 år og derover, hvoraf mindst 5 var 75 år og derover; n=14) var den samme som hos yngre kontrolpersoner (i alderen 25-45 år; n=14) efter oral administration af en enkelt dosis tedizolidphosphat på 200 mg.
English: In Phase 3 studies, subjects taking serotonergic agents including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and serotonin 5-hydroxytryptamine (5-HT1) receptor agonists (triptans), meperidine, or buspirone were excluded.
Danish: I fase 3-studier ekskluderedes forsøgspersoner, der tog serotonerge midler, herunder antidepressiva (som f.eks. selektive serotonin-genoptagelseshæmmere (SSRI), tricykliske antidepressiva), serotonin 5-hydroxytryptamin (5-HT1)-receptoragonister (triptaner), meperidin eller buspiron.
English: The film-coated tablets can be taken with or without food.
Danish: De filmovertrukne tabletter kan tages i forbindelse med et måltid eller mellem måltider.
English: • if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for tedizolidphosphat eller et af de øvrige indholdsstoffer i Sivextro
English: • sumatriptan, zolmitriptan (used to treat migraine)
Danish: • sumatriptan, zolmitriptan (til behandling af migræne)
English: • sulfasalazine (used to treat inflammatory bowel diseases)
Danish: • sulfasalazin (til behandling af inflammatoriske (betændelsesagtige) tarmsygdomme)
English: When incubated with pooled human liver microsomes, tedizolid was stable suggesting that tedizolid is not a substrate for hepatic CYP450 enzymes.
Danish: Når tedizolid blev inkuberet med puljede humane levermikrosomer, var det stabilt, hvilket tyder på, at tedizolid ikke er substrat for de hepatiske CYP-enzymer.
English: Two placebo-controlled crossover studies were conducted to assess the potential of 200 mg oral tedizolid phosphate at steady state to enhance pressor responses to pseudoephedrine and tyramine in healthy individuals.
Danish: Der er udført to placebo-kontrollerede overkrydsningsstudier for at vurdere, i hvilket omfang 200 mg oralt tedizolidphosphat ved steady state kan forstærke pressor-responset på pseudoephedrin og tyramin hos raske personer.
English: The mean steady state volume of distribution of tedizolid in healthy adults (n=8) following a single intravenous dose of tedizolid phosphate 200 mg ranged from 67 to 80 L.
Danish: Tedizolids gennemsnitlige fordelingsvolumen ved steady state hos raske voksne (n=8) efter en enkelt intravenøs dosis på 200 mg tedizolidphosphat var 67-80 l.
English: , Mg including Lactated Ringer's Injection and Hartmann's Solution.
Danish: ), herunder Ringer-lactat og Hartmann.
English: It must be administered as an intravenous infusion only.
Danish: Infusionsvæsken må kun administreres som intravenøs infusion.
English: It is available in packs containing 1 or 6 vials.
Danish: Sivextro fås i pakninger med 1 eller 6 hætteglas.
English: Lactic acidosis has not been reported in patients treated with tedizolid phosphate at the recommended treatment duration of 6 days.
Danish: Der er ikke rapporteret om laktatacidose hos patienter, der er blevet behandlet med tedizolidphosphat i den anbefalede behandlingsperiode på 6 dage.
English: In a mouse thigh infection model of S. aureus, the antibacterial activity of tedizolid was reduced in the absence of granulocytes.
Danish: I en S. aureus-infektionsmodel i muselår var tedizolids antibakterielle aktivitet nedsat ved fravær af granulocytter.
English: There is no Phase 3 clinical experience in patients with co-administration of tedizolid phosphate with serotonergic agents such as selective serotonin re-uptake inhibitors [SSRI], serotonin norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants, MAO inhibitors, triptans, and other medicines with potential adrenergic or serotonergic activity.
Danish: Der er ingen klinisk fase 3-erfaring med samtidig administration af tedizolidphosphat og serotonerge midler som f.eks. selektive serotonin-genoptagelseshæmmere [SSRI], serotonin/noradrenalingenoptagelseshæmmere (SNRI), tricykliske antidepressiva, MAO-hæmmere, triptaner og andre lægemidler med potentiel adrenerg eller serotonerg aktivitet.
English: Do not use this medicine after the expiry date which is stated on the carton or blister label after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken eller blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Type I (10 ml) clear borosilicate tubing glass vial with a siliconised grey chlorobutyl rubber stopper.
Danish: Type I-hætteglas (10 ml): cylinderformet, klart borosilicat-hætteglas med grå prop af silikoneret chlorbutylgummi.
English: The contents of the vial should be reconstituted with 4 mL of water for injections, and be swirled gently until the powder has dissolved entirely.
Danish: Indholdet af hætteglasset skal rekonstitueres med 4 ml vand til injektionsvæsker og omrystes forsigtigt, indtil pulveret er helt opløst.
English: Diabetes mellitus inadequate control
Danish: Utilstrækkelig regulering af diabetes mellitus Hyperkaliæmi
English: Skin And subcutaneous tissue disorders
Danish: Hud og subkutane væv
English: Haemodialysis does not result in meaningful removal of tedizolid from systemic circulation.
Danish: Hæmodialyse fjerner ikke tedizolid nævneværdigt fra den systemiske cirkulation.
English: Peripheral neuropathy, as well as optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with another member of the oxazolidinone class with treatment durations exceeding that recommended for tedizolid phosphate.
Danish: Perifer neuropati samt optisk neuropati, der i nogle tilfælde udviklede sig til synstab, er rapporteret hos patienter, der blev behandlet med et andet antibiotikum i oxazolidinon-klassen over en periode, der var længere end den behandlingsperiode, der anbefales for tedizolidphosphat.
English: Following single oral administration of
Danish: Efter en enkelt oral dosis
English: Table 1 Frequency of adverse reactions by System Organ Class in pooled Phase 3 comparative clinical studies
Danish: Tabel 1 Hyppighed af bivirkninger i puljede sammenlignende kliniske fase 3-studier (efter systemorganklasse)
English: In embryo-foetal studies, tedizolid phosphate was shown to produce foetal developmental toxicities in mice and rats.
Danish: Embryo-føtale studier har vist, at tedizolidphosphat har toksisk virkning på den føtale udvikling hos mus og rotter.
English: Neuropathy (optic and peripheral) has not been reported in patients treated with tedizolid phosphate at the recommended treatment duration of 6 days.
Danish: Neuropati (optisk og perifer) er ikke rapporteret hos patienter, der har fået tedizolidphosphat i den anbefalede periode på 6 dage.
English: • Swollen or enlarged lymph nodes
Danish: • Hævede eller forstørrede lymfeknuder
English: Intravenous use after reconstitution and dilution For single use only
Danish: Intravenøs anvendelse efter rekonstitution og fortynding.
English: A second resistance mechanism is encoded by a plasmid-borne and transposon associated chloramphenicol-florfenicol resistance (cfr) gene, conferring resistance in staphylococci and enterococci to oxazolidinones, phenicols, lincosamides, pleuromutilins, streptogramin A and 16membered macrolides.
Danish: En anden resistensmekanisme kodes af et plasmid-båret, transposon-associeret chloramphenicol/florphenicol-resistensgen (cfr-gen), hvilket giver resistens hos stafylokokker og enterokokker for oxazolidinoner, fenikoler, linkosamider, pleuromutiliner, streptogramin A og 16-leddede makrolider.
English: 6 vials
Danish: 6 hætteglas
English: Tedizolid phosphate was negative for genotoxicity in all in vitro assays (bacterial reverse mutation [Ames], Chinese hamster lung [CHL] cell chromosomal aberration) and in all in vivo tests (mouse bone marrow micronucleus, rat liver unscheduled DNA synthesis).
Danish: Tedizolidphosphat var negativt for genotoksicitet i alle in vitro-analyser (bakteriel revers mutationsanalyse [Ames' analyse], kromosomafvigelser i lungeceller fra kinesisk hamster) og i alle in vivo-test (mikronukleus i knoglemarv hos mus, ikke-planlagt dna-syntese i rottelever).
English: These effects showed evidence of reversibility and occurred at plasma tedizolid exposure levels (AUC) ≥6-fold greater than the plasma exposure associated with the human therapeutic dose.
Danish: Disse virkninger viste evidens for reversibilitet og sås ved tedizolid-plasmaeksponeringer (AUC), der var ≥6 gange højere end plasmaeksponeringen ved den humane terapeutiske dosis.
English: Therefore, orally administered tedizolid phosphate can result in inhibition of BCRP at the intestinal level.
Danish: Oralt administreret tedizolidphosphat kan derfor medføre hæmning af BCRP intestinalt.
English: Contact your doctor, pharmacist or nearest hospital casualty department as soon as possible if you have taken more tablets than you should, and take your medicine with you.
Danish: Hvis du har taget for mange Sivextro-tabletter Kontakt lægen, apotekspersonalet eller den nærmeste skadestue så hurtigt som muligt, hvis du har taget for mange tabletter, og medbring medicinen.
English: What Sivextro looks like and contents of the pack Sivextro is a white to off-white powder for concentrate for solution for infusion in a glass vial.
Danish: Sivextro er et hvidt til offwhite pulver til koncentrat til infusionsvæske i et hætteglas.
English: EU/1/15/991/002 1 vial EU/1/15/991/003 6 vials
Danish: EU/1/15/991/002 1 hætteglas EU/1/15/991/003 6 hætteglas
English: What Sivextro is and what it is used for What you need to know before you are given Sivextro How you will be given Sivextro Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du får Sivextro Sådan vil du få Sivextro Bivirkninger
English: Lactic acidosis has been reported with the use of another member of the oxazolidinone class.
Danish: Der er rapporteret om laktatacidose ved brug af et andet antibiotikum i oxazolidinon-klassen.
English: The time to tedizolid peak concentration with oral administration under fasting conditions is 6 hours faster than when administered with a high-fat, high-calorie meal (see section 5.2).
Danish: Ved oral administration af tedizolid opnås den maksimale koncentration 6 timer hurtigere under faste, end når tabletterne tages ved et måltid med højt fedt- og kalorieindhold (se pkt.
English: The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established (see section 4.4).
Danish: Tedizolidphosphats sikkerhed og virkning ved administration i mere end 6 dage er ikke klarlagt (se pkt.
English: Spontaneous reports of serotonin syndrome associated with the co-administration of another member of the oxazolidinone class together with serotonergic agents have been reported (see section 4.5).
Danish: Der er spontane indberetninger af serotoninsyndrom efter administration af et andet antibiotikum i oxazolidinon-klassen sammen med serotonerge midler (se pkt.
English: • loss of sensitivity in your hands or feet (such as numbness, prickling/tingling, or sharp pains)
Danish: • manglende følsomhed i hænder og/eller fødder (f.eks. følelsesløshed, prikkende/snurrende fornemmelse eller stikkende smerter)
English: For administration, the reconstituted solution must be further diluted in 250 mL 0.9% sodium chloride.
Danish: Inden administration skal det rekonstituerede koncentrat fortyndes yderligere i 250 ml natriumchloridinfusionsvæske 0,9 %.
English: These dose levels equate to exposure margins of ≥ 5.3-fold for males and ≥ 4.2-fold for females relative to tedizolid plasma AUC0-24 levels at the human oral therapeutic dose.
Danish: Disse dosisniveauer svarer til en tedizolid-plasmaeksponering på ≥5,3 gange hos hanrotter og på ≥4,2 gange hos hunrotter i forhold til AUC0-24 ved den orale humane terapeutiske dosis.
English: Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Danish: Sivextro er indiceret til behandling af akutte bakterieinfektioner i hud og hudstrukturer (acute bacterial skin and skin structure infections - ABSSSI) hos voksne (se pkt.
English: The mean Cmax and AUC0-∞ for oral or IV administration of tedizolid phosphate 200 mg were similar in adolescent and in healthy adult subjects.
Danish: De gennemsnitlige Cmaxog AUC0-∞-værdier efter oral og intravenøs administration af tedizolidphosphat 200 mg var af samme størrelsesorden hos unge forsøgspersoner som hos raske voksne forsøgspersoner.
English: What Sivextro contains
Danish: Sivextro indeholder:
English: In ABSSSI, the types of infections treated were confined to cellulitis/erysipelas or major cutaneous abscesses, and wound infections only.
Danish: Hvad angår akutte bakterieinfektioner i hud og hudstrukturer var de behandlede infektionstyper begrænset til cellulitis/erysipelas eller større kutane abscesser og sårinfektioner.
English: The pharmacokinetics of tedizolid were evaluated in adolescent subjects (12 to 17 years; n=20) following administration of a single oral or IV dose of tedizolid phosphate 200 mg.
Danish: Tedizolids farmakokinetik blev vurderet hos unge forsøgspersoner (i alderen 12-17 år; n=20) efter oral og intravenøs administration af en enkelt dosis tedizolidphosphat på 200 mg.
English: Tedizolid is bacteriostatic against enterococci, staphylococci, and streptococci in vitro.
Danish: Tedizolid virker bakteriostatisk på enterokokker, stafylokokker og streptokokker in vitro.
English: Infusion site
Danish: Reaktioner på infusionsstedet
English: Do not use this medicine after the expiry date which is stated on the vial label after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasetiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Tedizolid is excreted in the breast milk of rats (see section 5.3).
Danish: Tedizolid udskilles i mælk hos rotter (se pkt.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution og fortynding, se pkt.
English: The safety profile was similar when comparing patients receiving intravenous tedizolid phosphate alone to patients who received oral administration alone, except for a higher reported rate of gastrointestinal disorders associated with oral administration.
Danish: Sikkerhedsprofilen var sammenlignelig hos patienter, der fik monoterapi med tedizolidphosphat intravenøst, og patienter, der fik monoterapi med tedizolidphosphat oralt, bortset fra, at der blev rapporteret om flere gastrointestinale forstyrrelser ved oral administration.
English: The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established.
Danish: Tedizolidphosphats sikkerhed og virkning ved administration i mere end 6 dage er ikke klarlagt.
English: Following administration of a single 200 mg IV dose of tedizolid phosphate to 8 subjects with severe renal impairment defined as eGFR <30 mL/min, the Cmax was basically unchanged and AUC0-∞ was changed by less than 10% compared to 8 matched healthy subject controls.
Danish: Efter administration af en enkelt i.v.-dosis tedizolidphosphat på 200 mg hos 8 forsøgspersoner med svært nedsat nyrefunktion, defineret som eGFR < 30 ml/min, var Cmax stort set uændret, og AUC0-∞ var ændret med under 10 % i forhold til værdierne hos 8 raske forsøgspersoner.
English: Repeated oral and intravenous dosing of tedizolid phosphate in rats in 1-month and 3-month toxicology studies produced dose- and time-dependent bone marrow hypocellularity (myeloid, erythroid, and megakaryocyte), with associated reduction in circulating RBCs, WBCs, and platelets.
Danish: Gentagen oral og intravenøs dosering af tedizolidphosphat hos rotter i toksikologistudier over 1 og 3 måneder medførte dosis- og tidsafhængig hypocellulær knoglemarv (nedsat forekomst af myelocytter, erytrocytter og megakaryocytter) og dermed forbundet nedsættelse af cirkulerende røde blodlegemer, hvide blodlegemer og blodplader.
English: If you miss a dose of Sivextro Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.
Danish: Hvis en dosis er glemt Kontakt lægen eller sundhedspersonalet med det samme, hvis du tror, at en dosis måske er glemt.
English: • Respiratory tract (sinuses, throat and chest) infection
Danish: • Luftvejsinfektion (bihuler, hals og brystkasse)
English: Foetal developmental effects occurring in mice in the absence of maternal toxicity included reduced foetal weights and an increased incidence of costal cartilage fusion (an exacerbation of the normal genetic predisposition to sternal variations in the CD-1 strain of mice) at the high dose of 25 mg/kg/day (4-fold the estimated human exposure level based on AUCs).
Danish: Virkninger på den føtale udvikling hos mus, hvor der ikke blev set maternel toksicitet, omfattede nedsat fostervægt og en øget forekomst af ribbensbruskfusion (forstærkning af den normale genetiske disposition for sternale variationer i CD-1-stammen hos mus) ved den høje dosis på 25 mg/kg/dag (4 gange den estimerede humane eksponering baseret på AUC).
English: Insomnia Sleep disorder Anxiety Nightmare
Danish: Søvnløshed Søvnforstyrrelser Angst
English: Tedizolid is primarily active against Gram-positive bacteria.
Danish: Tedizolid virker primært mod grampositive bakterier.
English: It is used to treat adults with infections of the skin and tissues below the skin.
Danish: Det anvendes til at behandle infektioner i hud og hudstrukturer hos voksne.
English: As a precautionary measure, it is preferable to avoid the use of tedizolid phosphate during pregnancy.
Danish: For en sikkerheds skyld bør tedizolidphosphat undgås under graviditet.
English: • Allergic reaction
Danish: • Overfølsomhedsreaktion
English: Infusion related reaction Peripheral oedema
Danish: Infusionsrelaterede reaktioner Perifert ødem
English: - are taking certain medicines to treat depression, known as tricyclics, SSRIs (selective serotonin reuptake inhibitors) or MAOIs (monoamine oxidase inhibitors).
Danish: - hvis du tager lægemidler til behandling af depression af typen tricykliske antidepressiva, SSRI (selektive serotonin-genoptagelseshæmmere) eller MAO-hæmmere (monoaminoxidasehæmmere).
English: It is available in 6 × 1 tablets in perforated unit-dose blisters.
Danish: Sivextro-tabletterne fås i perforeret enkeltdosisblister med 6 x 1 tabletter.
English: The reconstituted solution will be withdrawn from the vial and added to an infusion bag of 0.9% sodium chloride in the hospital.
Danish: Det rekonstituerede koncentrat trækkes op af hætteglasset og tilsættes en infusionspose med 0,9% natriumchloridinfusionsvæske (foregår på hospitalet).
English: Decreased platelets, decreased haemoglobin and decreased neutrophils have been observed in a few subjects during treatment with tedizolid phosphate.
Danish: Der er observeret nedsat antal blodplader og neutrofile granulocytter samt nedsat hæmoglobinkoncentration hos enkelte forsøgspersoner under behandling med tedizolidphosphat.
English: What you need to know before you take Sivextro
Danish: Det skal du vide, før du begynder at tage Sivextro
English: What you need to know before you are given Sivextro
Danish: Det skal du vide, før du får Sivextro
English: Patients should not take a double dose to compensate for a missed dose.
Danish: Patienten må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Certain side effects have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for Sivextro.
Danish: Der er set en række bivirkninger ved brug af et andet lægemiddel i oxazolidinon-klassen over en længere periode end den, der anbefales for Sivextro.
English: A clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), demonstrated no clinically meaningful difference in midazolam Cmax or AUC.
Danish: Et klinisk studie, der sammenlignede enkeltdosisfarmakokinetikken (2 mg) for midazolam (CYP3A4substrat) alene eller i kombination med tedizolidphosphat (200 mg oral dosis en gang dagligt i 10 dage), viste ingen klinisk relevant forskel i midazolam Cmax eller AUC.
English: Tedizolid was positive in an in vitro CHL cell chromosomal aberration assay, but negative for genotoxicity in other in vitro assays (Ames, mouse lymphoma mutagenicity) and in vivo in a mouse bone marrow micronucleus assay.
Danish: Tedizolid var positivt for genotoksicitet i en in vitro-analyse af kromosomafvigelser i lungeceller fra kinesisk hamster, men negativt i andre in vitro-analyser (Ames' analyse, mutagenicitet i lymfomer hos mus) og i en in vivo-analyse af mikronukleus i knoglemarv hos mus.
English: At steady state, tedizolid mean (SD) Cmax values of 2.2 (0.6) and 3.0 (0.7) mcg/mL and AUC values of 25.6 (8.5) and 29.2 (6.2) mcg·h/mL were similar with oral and IV administration of tedizolid phosphate, respectively.
Danish: De gennemsnitlige værdier (SD) for tedizolid ved steady state var af samme størrelsesorden efter oral og intravenøs administration af tedizolidphosphat, idet Cmax var henholdsvis 2,2 (0,6) og 3,0 (0,7) mikrog/ml og AUC henholdsvis 25,6 (8,5) og 29,2 (6,2) mikrog·t/ml.
English: Drug metabolizing enzymes
Danish: Lægemiddelmetaboliserende enzymer