FrancophonIA/ELRC3.0 huggingface dataset:
English: • Sleepiness, abnormal sleep pattern, difficulty sleeping, nightmares (unpleasant/disturbing dreams)
Danish: • Søvnighed, unormalt søvnmønster, søvnbesvær, mareridt (ubehagelige/forstyrrende drømme)
English: The combined storage time (from reconstitution to dilution to administration) must not exceed 24 hours when stored at either room temperature or in a refrigerator (2°C - 8°C).
Danish: Den samlede opbevaringstid (fra rekonstitution til fortynding og til administration) må ikke overstige 24 timer, hvis den rekonstituerede og fortyndede opløsning opbevares ved enten stuetemperatur eller i køleskab (2-8 °C).
English: There are limited data in patients on the interaction between serotonergic agents and tedizolid phosphate.
Danish: Der foreligger kun begrænsede patientdata, hvad angår interaktion mellem serotonerge midler og tedizolidphosphat.
English: The safety and efficacy of tedizolid phosphate in patients with neutropenia (neutrophil counts <1,000 cells/mm
Danish: Tedizolidphosphats sikkerhed og virkning hos patienter med neutropeni (neutrofiltal <1.000 celler/mm
English: Antibacterial activity in combination with other antibacterial and antifungal agents
Danish: Antibakteriel aktivitet ved kombination med andre antibakterielle og svampedræbende midler
English: Tedizolid phosphate should be administered with caution in patients known to be hypersensitive to other oxazolidinones since cross-hypersensitivity may occur.
Danish: Tedizolidphosphat skal administreres med forsigtighed hos patienter, der er overfølsomme over for andre oxazolidinon-præparater, da der kan opstå krydsoverfølsomhed.
English: • statins such as pitavastatin, rosuvastatin (used to lower blood cholesterol)
Danish: • statiner som f.eks. pitavastatin, rosuvastatin (mod forhøjet kolesterol)
English: The following adverse reactions have been identified in two comparative pivotal Phase 3 studies with Sivextro (Table 1).
Danish: Følgende bivirkninger er set i to sammenlignende pivotale fase 3-studier med Sivextro (tabel 1).
English: The film coat of the tablet contains polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and yellow iron oxide (E172).
Danish: Tablettens filmovertræk indeholder polyvinylalkohol, titandioxid (E171), macrogol, talcum og gul jernoxid (E172).
English: It is unknown whether tedizolid phosphate or its metabolites are excreted in human milk.
Danish: Det er ukendt, om tedizolidphosphat/metabolitter udskilles i human mælk.
English: • a low white blood cell count
Danish: • lavt antal hvide blodlegemer
English: If you stop taking Sivextro
Danish: Hvis du holder op med at tage Sivextro
English: Film-coated tablet 6 x 1 film-coated tablets
Danish: Filmovertrukken tablet 6 x 1 filmovertrukne tabletter
English: Animal studies with tedizolid phosphate do not indicate harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier med tedizolidphosphat indikerer ikke nogen skadelige virkninger på fertiliteten (se pkt.
English: - are taking certain medicines to treat migraine known as “triptans”.
Danish: - hvis du tager lægemidler til behandling af migræne af typen ”triptaner”.
English: • amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine,
Danish: • amitriptylin, citalopram, clomipramin, dosulepin, doxepin, fluoxetin, fluvoxamin, imipramin,
English: imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline and sertraline (used to treat depression)
Danish: isocarboxazid, lofepramin, moclobemid, paroxetin, phenelzin, selegilin og sertralin (til behandling af depression)
English: The potential for serotonergic interactions has not been studied in either patients or healthy volunteers (see section 5.2).
Danish: Muligheden for serotonerge interaktioner er hverken undersøgt hos patienter eller raske forsøgspersoner (se pkt.
English: Recommended dose and duration The recommended dosage is 200 mg once daily for 6 days.
Danish: Anbefalet dosis og behandlingsvarighed Den anbefalede dosis er 200 mg en gang dagligt i 6 dage.
English: Serotonergic effects at doses of tedizolid phosphate up to 30-fold above the human equivalent dose did not differ from vehicle control in a mouse model that predicts brain serotonergic activity.
Danish: Den serotonerge virkning ved tedizolidphosphat-doser på op til 30 gange den ækvivalente humane dosis var ikke forskellig fra den inaktive kontrol i en musemodel, der forudsiger hjernens serotonerge aktivitet.
English: • Swelling in ankles and/or feet
Danish: • Hævede ankler og/eller fødder
English: It belongs to a group of medicines called “oxazolidinones.”
Danish: Det tilhører en gruppe lægemidler, der kaldes ”oxazolidinoner”.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to tedizolid in vitro.
Danish: I kliniske studier er der påvist virkning mod de patogener, der er anført under hver af de indikationer, hvor der var følsomhed for tedizolid in vitro.
English: • imatinib, lapatinib (used to treat cancer)
Danish: • imatinib, lapatinib (til behandling af kræft)
English: Reconstituted solutions containing visible particles should be discarded.
Danish: Koncentrat/infusionsvæske, der indeholder synlige partikler, skal kasseres.
English: Limitations of the clinical data
Danish: Begrænsede kliniske data
English: Multiple sulfotransferase (SULT) enzymes (SULT1A1, SULT1A2, and SULT2A1) are involved in the biotransformation of tedizolid, to form an inactive and non-circulating sulphate conjugate found in the excreta.
Danish: Flere SULT-enzymer (sulfotransferase-enzymer), nemlig SULT1A1, SULT1A2 og SULT2A1, er involveret i biotransformationen af tedizolid, hvor der dannes et inaktivt og ikke-cirkulerende sulfatkonjugat, som udskilles ved ekskretion.
English: Sivextro is an antibiotic that contains the active substance tedizolid phosphate.
Danish: Sivextro er et antibiotikum, der indeholder det aktive stof tedizolidphosphat.
English: Other side effects may include:
Danish: Andre bivirkninger:
English: Beta haemolytic Streptococci of Groups A,B,C,G Viridans group streptococci (Streptococcus anginosus group only)
Danish: Beta-hæmolytiske Streptococci (gruppe A, B, C, G) Streptococci i viridans-gruppen (kun Streptococcus anginosus-gruppen)
English: Do not use Sivextro:
Danish: Tag ikke Sivextro:
English: • methotrexate (used to treat cancer, rheumatoid arthritis or psoriasis)
Danish: • methotrexat (til behandling af kræft, leddegigt eller psoriasis)
English: Susceptible (≤S) Resistant (R>)
Danish: Resistent (R>)
English: Tedizolid phosphate film-coated tablets or powder for concentrate for solution for infusion may be used as initial therapy.
Danish: Filmovertrukne tedizolidphosphat-tabletter eller tedizolidphosphat-pulver til koncentrat til infusionsvæske kan bruges som indledende behandling.
English: • The other ingredients are microcrystalline cellulose, mannitol, povidone, crospovidone and magnesium stearate within the tablet core.
Danish: • Øvrige indholdsstoffer: mikrokrystallinsk cellulose, mannitol, povidon, crospovidon og magnesiumstearat i selve tabletkernen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Sivextro in one or more subsets of the paediatric population in the treatment of acute bacterial skin and skin structure infections (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Sivextro i en eller flere undergrupper af den pædiatriske population ved behandling af akutte bakterieinfektioner i hud og hudstrukturer (se pkt.
English: • Decrease or loss of skin sensitivity, tingling/prickling skin sensation
Danish: • Nedsættelse eller tab af følsomheden i huden, stikkende/prikkende fornemmelse i huden
English: Tedizolid did not alter activity of selected CYP isoenzymes, but induction of CYP3A4 mRNA was observed in vitro in hepatocytes.
Danish: Tedizolid ændrede ikke aktiviteten af udvalgte CYP-isoenzymer, men der sås inducerende virkning på CYP3A4-mRNA i hepatocytter in vitro.
English: Prescribing tedizolid phosphate in the absence of a proven or strongly suspected bacterial infection increases the risk of the development of drug-resistant bacteria.
Danish: Hvis tedizolidphosphat ordineres, uden at en bakteriel infektion er bekræftet, eller der er stærk mistanke herom, øges risikoen for udvikling af resistente bakterier.
English: The resulting solution is a clear colourless or light-yellow solution.
Danish: Den færdige infusionsvæske er en klar, farveløs eller lysegul opløsning.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Danish: Natriumhydroxid (til justering af pH) Saltsyre (til justering af pH)
English: Organisms resistant to oxazolidinones via mutations in chromosomal genes encoding 23S rRNA or ribosomal proteins (L3 and L4) are generally cross-resistant to tedizolid.
Danish: Organismer, der er resistente over for oxazolidinoner via mutationer i de kromosomale gener, der koder for 23S rRNA eller de ribosomale proteiner L3 og L4, udviser generelt krydsresistens med tedizolid.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tedizolid phosphate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med tedizolidphosphat skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In vitro studies in human liver microsomes indicate that tedizolid phosphate and tedizolid do not significantly inhibit metabolism mediated by any of the following CYP isoenzymes (CYP1A2, CYP2C19, CYP2A6, CYP2C8, CYP2C9, CYP2D6, and CYP3A4).
Danish: In vitro-studier med humane levermikrosomer tyder på, at tedizolidphosphat og tedizolid ikke har signifikant hæmmende virkning på metabolisering, der medieres af følgende CYP-isoenzymer: CYP1A2, CYP2C19, CYP2A6, CYP2C8, CYP2C9, CYP2D6 og CYP3A4.
English: If the same intravenous line is used for sequential infusion of several different medicinal products, the line should be flushed before and after infusion with 0.9% sodium chloride.
Danish: Hvis den samme intravenøse slange anvendes til sekventiel infusion af flere forskellige lægemidler, skal den skylles med natriumchlorid 0,9 % før og efter infusionen.
English: Peripheral neuropathy and optic nerve disorders
Danish: Perifer neuropati og forstyrrelser i synsnerven
English: Effects of Sivextro on other medicines
Danish: Sivextros virkning på andre lægemidler
English: If you forget to take Sivextro
Danish: Hvis du har glemt at tage Sivextro
English: Tedizolid phosphate is an oxazolidinone phosphate prodrug.
Danish: Tedizolidphosphat er et prodrug for oxazolidinonfosfat.
English: • The other ingredients are mannitol, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).
Danish: • Øvrige indholdsstoffer: mannitol, natriumhydroxid (til justering af pH) og saltsyre (til justering af pH).
English: Vulvovaginal mycotic infection Fungal infection Vulvovaginal candidiasis Abscess
Danish: Vulvovaginal svampeinfektion Svampeinfektion Vulvovaginal candidiasis Absces
English: • Abscess (swollen, pus-filled lump)
Danish: • Byld (hævet, pusfyldt bule)
English: Do not use this medicine if you notice any particles or the solution is cloudy.
Danish: Medicinen må ikke anvendes, hvis der er synlige partikler i den, eller hvis den er uklar.
English: Clostridioides difficile associated diarrhoea (CDAD) has been reported for tedizolid phosphate (see section 4.8).
Danish: Clostridioides difficile-associeret diarré (CDAD) er blevet rapporteret i forbindelse med tedizolidphosphat (se pkt.
English: Shaking or rapid movement should be avoided as it may cause foaming.
Danish: Kraftig omrystning og hurtige bevægelser skal undgås, da der ellers kan dannes skum.
English: Laboratoires Merck Sharp & Dohme-Chibret Route de Marsat, Riom 63963, Clermont-Ferrand Cedex 9 France
Danish: Laboratoires Merck Sharp & Dohme-Chibret Route de Marsat, Riom 63963, Clermont-Ferrand Cedex 9 Frankrig
English: • The active substance is tedizolid phosphate.
Danish: • Aktivt stof: tedizolidphosphat.
English: In vitro studies have shown that drug interactions between tedizolid and inhibitors or inducers of cytochrome P450 (CYP) isoenzymes are unanticipated.
Danish: In vitro-studier har vist, at der ikke forventes lægemiddelinteraktion mellem tedizolid og hæmmere eller inducere af cytochrom P450 (CYP)-isoenzymer.
English: mannitol, sodium hydroxide, hydrochloric acid
Danish: mannitol, natriumhydroxid, saltsyre
English: No meaningful changes in blood pressure or heart rate with pseudoephedrine were observed in the healthy volunteers, and no clinically relevant increase in tyramine sensitivity was observed.
Danish: Der sås ingen nævneværdige ændringer i blodtryk eller hjertefrekvens ved samtidig administration af pseudoephedrin hos raske forsøgspersoner, og der sås ingen klinisk relevant øget tyramin-følsomhed.
English: The antibacterial activity of tedizolid is mediated by binding to the 50S subunit of the bacterial ribosome resulting in inhibition of protein synthesis.
Danish: Tedizolids antibakterielle aktivitet medieres ved binding til bakteriens ribosomunderenhed 50S, hvorved proteinsyntesen hæmmes.
English: There is limited experience with tedizolid phosphate in the treatment of patients with concomitant acute bacterial skin and skin structure infections and secondary bacteremia and no experience in the treatment of ABSSSI with severe sepsis or septic shock.
Danish: Der er begrænset erfaring med tedizolidphosphat ved behandling af patienter med akutte bakterieinfektioner i hud og hudstrukturer og samtidig sekundær bakteriæmi, og der er ingen erfaring med behandling af akutte bakterieinfektioner i hud og hudstrukturer med samtidig svær sepsis eller septisk shock.
English: Oval (13.8 mm long by 7.4 mm wide) yellow film-coated tablet debossed with “TZD” on the obverse side and “200” on the reverse side.
Danish: Oval (13,8 mm lang og 7,4 mm bred), gul filmovertrukket tablet præget med "TZD" på den ene side og '200' på den anden.
English: The following adverse reactions have been identified in two comparative pivotal Phase 3 studies and one post-authorisation study with Sivextro (Table 1).
Danish: Følgende bivirkninger er set i to sammenlignende pivotale fase 3-studier og i et studie efter udstedelse af markedsføringstilladelse med Sivextro (tabel 1).
English: It is not known if Sivextro passes into breast milk in humans.
Danish: Det er ukendt, om Sivextro udskilles i mælken hos mennesker.
English: The reconstituted solution should be inspected visually for particulate matter prior to administration.
Danish: Det rekonstituerede koncentrat og infusionsvæsken skal kontrolleres for synlige partikler inden administration.
English: Oral and intravenous tedizolid phosphate is a prodrug that is rapidly converted by phosphatases to tedizolid, the microbiologically active moiety.
Danish: Oralt og intravenøst tedizolidphosphat er et prodrug, der hurtigt omdannes af fosfataser til tedizolid, den mikrobiologisk aktive del.
English: Therefore, orally administered Sivextro can result in inhibition of BCRP at the intestinal level.
Danish: Oralt administreret Sivextro kan derfor medføre hæmning af BCRP intestinalt.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du får dette lægemiddel.
English: • Anxiety, irritability, shaking or trembling
Danish: • Angst, irritabilitet, rysten eller skælven
English: Tedizolid is excreted into the milk of lactating rats and the concentrations observed were similar to those in maternal plasma.
Danish: Tedizolid udskilles i mælken hos diegivende rotter, og de observerede koncentrationer svarede til koncentrationerne i maternelt plasma.
English: The most frequently reported adverse reactions occurring in patients receiving tedizolid phosphate in the pooled controlled Phase 3 clinical studies (tedizolid phosphate 200 mg once daily for 6 days) were nausea (6.9%), headache (3.5%), diarrhoea (3.2%) and vomiting (2.3%), and were generally mild to moderate in severity.
Danish: De bivirkninger, der sås hyppigst blandt de patienter, der fik tedizolidphosphat i de puljede kontrollerede kliniske fase 3-studier (tedizolidphosphat 200 mg en gang dagligt i 6 dage), var kvalme (6,9 %), hovedpine (3,5 %), diarré (3,2 %) og opkastning (2,3 %).
English: Embryo-foetal development studies in mice and rats showed no evidence of a teratogenic effect at exposure levels 4-fold and 6-fold, respectively, those expected in humans.
Danish: I studier, hvor den embryo-føtale udvikling hos mus og rotter blev undersøgt, sås ingen evidens for teratogene virkninger ved eksponeringer, der var henholdsvis 4 og 6 gange større end den forventede eksponering hos mennesker.
English: No dose adjustment is necessary for co-administered CYP3A4 substrates during treatment with Sivextro.
Danish: Dosisjustering er ikke nødvendig for samtidigt administrerede CYP3A4-substrater under behandling med Sivextro.
English: In a 1-month immunotoxicology study in rats, repeated oral dosing of tedizolid phosphate was shown to significantly reduce splenic B cells and T cells and reduce plasma IgG titers.
Danish: Et 1-måneders immuntoksikologistudie hos rotter viste, at gentagen oral dosering af tedizolidphosphat medførte signifikant reduktion af B- og T-celler i milten og reduktion af IgG-titere i plasma.
English: Peak plasma tedizolid concentrations are achieved within approximately 3 hours after dosing after oral administration of tedizolid phosphate under fasted conditions.
Danish: Tedizolids maksimale plasmakoncentration nås ca. 3 timer efter oral administration af tedizolidphosphat ved faste.
English: The median tyramine dose required to cause an increase in systolic blood pressure of ≥30 mmHg from pre-dose baseline was 325 mg with tedizolid phosphate compared to 425 mg with placebo.
Danish: Den mediane tyramindosis, der var påkrævet for at opnå en stigning i det systoliske blodtryk på ≥30 mmHg i forhold til baseline (før dosisindgivelse), var 325 mg ved tedizolidphosphat sammenholdt med 425 mg ved placebo.
English: What Sivextro looks like and contents of the pack Sivextro is an oval, yellow film-coated tablet imprinted with ‘TZD' on one side and ‘200' on the other side.
Danish: Sivextro er en oval, gul filmovertrukket tablet præget med "TZD" på den ene side og '200' på den anden side.
English: If possible, an interruption of the co-administered BCRP substrate medicinal product (such as imatinib, lapatinib, methotrexate, pitavastatin, rosuvastatin, sulfasalazine, and topotecan) should be considered during the 6 days of treatment with oral tedizolid phosphate.
Danish: Hvis det er muligt, bør afbrydelse af det samtidigt administrerede BCRP-substrat-lægemiddel (f.eks. imatinib, lapatinib, methotrexat, pitavastatin, rosuvastatin, sulfasalazin og topotecan) overvejes under de 6 behandlingsdage med oralt tedizolidphosphat.
English: 6 × 1 tablets in aluminum/Polyethylene Terephthalate (PET)/Paper foil and polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) clear film perforated child-resistant unit-dose blisters.
Danish: 6 x 1 tabletter i perforeret børnesikret enkeltdosisblister af aluminium/polyethylenterephthalat (PET)/papir-folie med klar film af polyvinylchlorid (PVC)/polyvinylidenchlorid (PVdC).
English: In an animal model of infection, the antibacterial activity of tedizolid was reduced in the absence of granulocytes.
Danish: I en infektionsmodel hos dyr var tedizolids antibakterielle aktivitet nedsat ved fravær af granulocytter.
English: Tedizolid is generally not active against Gram-negative bacteria.
Danish: Tedizolid virker generelt ikke mod gramnegative bakterier.
English: The pharmacokinetics of tedizolid were similar in males and females.
Danish: Tedizolids farmakokinetik var sammenlignelig hos mænd og kvinder.
English: Studies in mice and rats showed developmental effects (see section 5.3).
Danish: Studier med mus og rotter har vist en effekt på fosterudviklingen (se pkt.
English: The powder will be reconstituted in the vial with 4 mL of water for injections.
Danish: Pulveret rekonstitueres i hætteglasset med 4 ml vand til injektionsvæsker.
English: • Blurred vision, ‘floaters' (small shapes seen floating in the field of vision)
Danish: • Sløret syn, "flyvende fluer" (små partikler i synsfeltet)
English: Tedizolid phosphate had no adverse effects on the fertility or reproductive performance of male rats, including spermatogenesis, at oral doses up to the maximum tested dose of 50 mg/kg/day, or adult female rats at oral doses up to the maximum tested dose of 15 mg/kg/day.
Danish: Tedizolidphosphat havde ingen uønskede virkninger på fertiliteten eller reproduktionsevnen, herunder spermatogenesen, hos hanrotter ved orale doser på op til den testede maksimaldosis på 50 mg/kg/dag eller hos voksne hunrotter ved orale doser på op til den testede maksimaldosis på 15 mg/kg/dag.
English: Sivextro contains sodium
Danish: Sivextro indeholder natrium
English: Tedizolid is a reversible, non-selective inhibitor of monoamine oxidase (MAO) in vitro (see section 4.5).
Danish: Tedizolid er en reversibel, non-selektiv hæmmer af monoaminoxidase (MAO) in vitro (se pkt.
English: Peak concentrations (Cmax) of tedizolid are reduced by approximately 26% and delayed by 6 hours when tedizolid phosphate is administered after a high-fat meal relative to fasted, while total exposure (AUC0-∞) is unchanged between fasted and fed conditions.
Danish: Tedizolids maksimale koncentration (Cmax) reduceres med ca. 26 % og forsinkes med 6 timer, når tedizolidphosphat administreres efter et måltid med højt fedtindhold sammenlignet med ved faste, mens den totale eksponering (AUC0-∞) er uændret, uanset om patienten faster eller har fået mad.
English: Following administration of a single 200 mg oral dose of tedizolid phosphate, the pharmacokinetics of tedizolid are not altered in patients with moderate (n=8) or severe (n=8) hepatic impairment (Child-Pugh Class B and C).
Danish: Efter administration af en enkelt oral dosis tedizolidphosphat på 200 mg var tedizolids farmakokinetik ikke ændret hos patienter med moderat nedsat (n=8) eller svært nedsat leverfunktion (n=8) (ChildPugh B og C).
English: Available in packs of 1 vial and 6 vials.
Danish: Fås i pakninger med 1 hætteglas og 6 hætteglas.
English: • any problems with your eyesight such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Danish: • problemer med øjnene, f.eks. sløret syn, ændret farveopfattelse, udviskede detaljer eller nedsat synsfelt.
English: Sivextro vials are intended for single use only.
Danish: Sivextro-hætteglassene er kun til engangsbrug.
English: In vitro drug combination studies with tedizolid and amphotericin B, aztreonam, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, colistin, daptomycin, gentamicin, imipenem, ketoconazole, minocycline, piperacillin, rifampicin, terbinafine, trimethoprim/sulfamethoxazole, and vancomycin indicate that neither synergy nor antagonism have been demonstrated.
Danish: I in vitro-studier, hvor tedizolid blev givet i kombination med amphotericin B, aztreonam, ceftazidim, ceftriaxon, ciprofloxacin, clindamycin, colistin, daptomycin, gentamicin, imipenem, ketoconazol, minocyclin, piperacillin, rifampicin, terbinafin, trimethoprim/sulfamethoxazol og vancomycin, blev der hverken påvist synergi eller antagonisme.
English: Sivextro must be reconstituted with water for injections and subsequently diluted in 250 mL of 0.9% sodium chloride for infusion.
Danish: Sivextro skal rekonstitueres med vand til injektionsvæsker og derefter fortyndes i 250 ml natriumchloridinfusionsvæske 0,9 %.