natgillin/translations-raw huggingface dataset:
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 %).
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.
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.
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.
Dosisjustering er ikke nødvendig for samtidigt administrerede CYP3A4-substrater under behandling med Sivextro.
No dose adjustment is necessary for co-administered CYP3A4 substrates during treatment with Sivextro.
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.
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.
Tedizolids maksimale plasmakoncentration nås ca. 3 timer efter oral administration af tedizolidphosphat ved faste.
Peak plasma tedizolid concentrations are achieved within approximately 3 hours after dosing after oral administration of tedizolid phosphate under fasted conditions.
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.
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.
Sivextro er en oval, gul filmovertrukket tablet præget med "TZD" på den ene side og '200' på den anden side.
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.
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.
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.
6 x 1 tabletter i perforeret børnesikret enkeltdosisblister af aluminium/polyethylenterephthalat (PET)/papir-folie med klar film af polyvinylchlorid (PVC)/polyvinylidenchlorid (PVdC).
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.
I en infektionsmodel hos dyr var tedizolids antibakterielle aktivitet nedsat ved fravær af granulocytter.
In an animal model of infection, the antibacterial activity of tedizolid was reduced in the absence of granulocytes.
Tedizolid virker generelt ikke mod gramnegative bakterier.
Tedizolid is generally not active against Gram-negative bacteria.
Tedizolids farmakokinetik var sammenlignelig hos mænd og kvinder.
The pharmacokinetics of tedizolid were similar in males and females.
Studier med mus og rotter har vist en effekt på fosterudviklingen (se pkt.
Studies in mice and rats showed developmental effects (see section 5.3).
Pulveret rekonstitueres i hætteglasset med 4 ml vand til injektionsvæsker.
The powder will be reconstituted in the vial with 4 mL of water for injections.
• Sløret syn, "flyvende fluer" (små partikler i synsfeltet)
• Blurred vision, ‘floaters' (small shapes seen floating in the field of vision)
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.
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.
Sivextro indeholder natrium
Sivextro contains sodium
Tedizolid er en reversibel, non-selektiv hæmmer af monoaminoxidase (MAO) in vitro (se pkt.
Tedizolid is a reversible, non-selective inhibitor of monoamine oxidase (MAO) in vitro (see section 4.5).
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.
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.
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).
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).
Fås i pakninger med 1 hætteglas og 6 hætteglas.
Available in packs of 1 vial and 6 vials.
• problemer med øjnene, f.eks. sløret syn, ændret farveopfattelse, udviskede detaljer eller nedsat synsfelt.
• 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.
Sivextro-hætteglassene er kun til engangsbrug.
Sivextro vials are intended for single use only.
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.
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.
Sivextro skal rekonstitueres med vand til injektionsvæsker og derefter fortyndes i 250 ml natriumchloridinfusionsvæske 0,9 %.
Sivextro must be reconstituted with water for injections and subsequently diluted in 250 mL of 0.9% sodium chloride for infusion.
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.
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.
Gastroøsofageal reflukssygdom Hæmatokeksi
Gastrooesophageal reflux disease
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.
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.
Disse virkninger sås ved tedizolid-plasmaeksponeringer (AUC), der var ≥3 gange højere end den forventede humane plasmaeksponering ved den terapeutiske dosis.
These effects occurred at plasma tedizolid exposure levels (AUC) ≥3-fold greater than the expected human plasma exposure associated with the therapeutic dose.
Andre lægemidlers virkning på Sivextro
Effects of other medicines on Sivextro
• blodmangel (lavt antal røde blodlegemer; også kaldet anæmi)
• anaemia (low red blood cells)
Tabel 1 Hyppighed af bivirkninger i sammenlignende kliniske studier (efter systemorganklasse)
Table 1 Frequency of adverse reactions by System Organ Class in comparative clinical studies
Sivextro er uforligeligt med alle infusionsvæsker, der indeholder divalente kationer (f.eks.
Sivextro is incompatible with any solutions containing divalent cations (e.g., Ca
Denne virkning er ikke klinisk relevant, og dosisjustering er ikke nødvendig for samtidigt administrerede CYP3A4-substrater under behandling med tedizolidphosphat.
This effect is not clinically meaningful, and no dose adjustment for co-administered CYP3A4 substrates is necessary during tedizolid phosphate treatment.
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.
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.
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.
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.
De filmovertrukne tabletter kan tages i forbindelse med et måltid eller mellem måltider.
The film-coated tablets can be taken with or without food.
• hvis du er allergisk over for tedizolidphosphat eller et af de øvrige indholdsstoffer i Sivextro
• if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed in section 6).
• sumatriptan, zolmitriptan (til behandling af migræne)
• sumatriptan, zolmitriptan (used to treat migraine)
• sulfasalazin (til behandling af inflammatoriske (betændelsesagtige) tarmsygdomme)
• sulfasalazine (used to treat inflammatory bowel diseases)
Når tedizolid blev inkuberet med puljede humane levermikrosomer, var det stabilt, hvilket tyder på, at tedizolid ikke er substrat for de hepatiske CYP-enzymer.
When incubated with pooled human liver microsomes, tedizolid was stable suggesting that tedizolid is not a substrate for hepatic CYP450 enzymes.
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.
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.
Tedizolids gennemsnitlige fordelingsvolumen ved steady state hos raske voksne (n=8) efter en enkelt intravenøs dosis på 200 mg tedizolidphosphat var 67-80 l.
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.
), herunder Ringer-lactat og Hartmann.
, Mg including Lactated Ringer's Injection and Hartmann's Solution.
Infusionsvæsken må kun administreres som intravenøs infusion.
It must be administered as an intravenous infusion only.
Sivextro fås i pakninger med 1 eller 6 hætteglas.
It is available in packs containing 1 or 6 vials.
Der er ikke rapporteret om laktatacidose hos patienter, der er blevet behandlet med tedizolidphosphat i den anbefalede behandlingsperiode på 6 dage.
Lactic acidosis has not been reported in patients treated with tedizolid phosphate at the recommended treatment duration of 6 days.
I en S. aureus-infektionsmodel i muselår var tedizolids antibakterielle aktivitet nedsat ved fravær af granulocytter.
In a mouse thigh infection model of S. aureus, the antibacterial activity of tedizolid was reduced in the absence of granulocytes.
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.
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.
Brug ikke lægemidlet efter den udløbsdato, der står på æsken eller blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton or blister label after “EXP”.
Type I-hætteglas (10 ml): cylinderformet, klart borosilicat-hætteglas med grå prop af silikoneret chlorbutylgummi.
Type I (10 ml) clear borosilicate tubing glass vial with a siliconised grey chlorobutyl rubber stopper.
Indholdet af hætteglasset skal rekonstitueres med 4 ml vand til injektionsvæsker og omrystes forsigtigt, indtil pulveret er helt opløst.
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.
Utilstrækkelig regulering af diabetes mellitus Hyperkaliæmi
Diabetes mellitus inadequate control
Hud og subkutane væv
Skin And subcutaneous tissue disorders
Hæmodialyse fjerner ikke tedizolid nævneværdigt fra den systemiske cirkulation.
Haemodialysis does not result in meaningful removal of tedizolid from systemic circulation.
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.
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.
Efter en enkelt oral dosis
Following single oral administration of
Tabel 1 Hyppighed af bivirkninger i puljede sammenlignende kliniske fase 3-studier (efter systemorganklasse)
Table 1 Frequency of adverse reactions by System Organ Class in pooled Phase 3 comparative clinical studies
Embryo-føtale studier har vist, at tedizolidphosphat har toksisk virkning på den føtale udvikling hos mus og rotter.
In embryo-foetal studies, tedizolid phosphate was shown to produce foetal developmental toxicities in mice and rats.
Neuropati (optisk og perifer) er ikke rapporteret hos patienter, der har fået tedizolidphosphat i den anbefalede periode på 6 dage.
Neuropathy (optic and peripheral) has not been reported in patients treated with tedizolid phosphate at the recommended treatment duration of 6 days.
• Hævede eller forstørrede lymfeknuder
• Swollen or enlarged lymph nodes
Intravenøs anvendelse efter rekonstitution og fortynding.
Intravenous use after reconstitution and dilution For single use only
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.
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.
6 hætteglas
6 vials
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).
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).
Disse virkninger viste evidens for reversibilitet og sås ved tedizolid-plasmaeksponeringer (AUC), der var ≥6 gange højere end plasmaeksponeringen ved den humane terapeutiske dosis.
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.
Oralt administreret tedizolidphosphat kan derfor medføre hæmning af BCRP intestinalt.
Therefore, orally administered tedizolid phosphate can result in inhibition of BCRP at the intestinal level.
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.
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.
Sivextro er et hvidt til offwhite pulver til koncentrat til infusionsvæske i et hætteglas.
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.
EU/1/15/991/002 1 hætteglas EU/1/15/991/003 6 hætteglas
EU/1/15/991/002 1 vial EU/1/15/991/003 6 vials
Virkning og anvendelse Det skal du vide, før du får Sivextro Sådan vil du få Sivextro Bivirkninger
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
Der er rapporteret om laktatacidose ved brug af et andet antibiotikum i oxazolidinon-klassen.
Lactic acidosis has been reported with the use of another member of the oxazolidinone class.
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.
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).
Tedizolidphosphats sikkerhed og virkning ved administration i mere end 6 dage er ikke klarlagt (se pkt.
The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established (see section 4.4).
Der er spontane indberetninger af serotoninsyndrom efter administration af et andet antibiotikum i oxazolidinon-klassen sammen med serotonerge midler (se pkt.
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).
• manglende følsomhed i hænder og/eller fødder (f.eks. følelsesløshed, prikkende/snurrende fornemmelse eller stikkende smerter)
• loss of sensitivity in your hands or feet (such as numbness, prickling/tingling, or sharp pains)
Inden administration skal det rekonstituerede koncentrat fortyndes yderligere i 250 ml natriumchloridinfusionsvæske 0,9 %.
For administration, the reconstituted solution must be further diluted in 250 mL 0.9% sodium chloride.
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.
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.
Sivextro er indiceret til behandling af akutte bakterieinfektioner i hud og hudstrukturer (acute bacterial skin and skin structure infections - ABSSSI) hos voksne (se pkt.
Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
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.
The mean Cmax and AUC0-∞ for oral or IV administration of tedizolid phosphate 200 mg were similar in adolescent and in healthy adult subjects.
Sivextro indeholder:
What Sivextro contains
Hvad angår akutte bakterieinfektioner i hud og hudstrukturer var de behandlede infektionstyper begrænset til cellulitis/erysipelas eller større kutane abscesser og sårinfektioner.
In ABSSSI, the types of infections treated were confined to cellulitis/erysipelas or major cutaneous abscesses, and wound infections only.
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.
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.
Tedizolid virker bakteriostatisk på enterokokker, stafylokokker og streptokokker in vitro.
Tedizolid is bacteriostatic against enterococci, staphylococci, and streptococci in vitro.
Reaktioner på infusionsstedet
Infusion site
Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasetiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the vial label after “EXP”.
Tedizolid udskilles i mælk hos rotter (se pkt.
Tedizolid is excreted in the breast milk of rats (see section 5.3).
Opbevaringsforhold efter rekonstitution og fortynding, se pkt.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
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.
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.
Tedizolidphosphats sikkerhed og virkning ved administration i mere end 6 dage er ikke klarlagt.
The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established.