natgillin/translations-raw huggingface dataset:
Der er ingen målbaseret krydsresistens mellem tigecyclin og de fleste antibiotikaklasser.
There is no target-based cross-resistance between tigecycline and most classes of antibiotics.
Tygacil er et antibiotikum tilhørende glycylcyklingruppen, som virker ved at stoppe den bakterievækst, der forårsager infektioner.
Tygacil is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.
Samtidig brug af antibiotika og perorale antikonceptiva kan gøre perorale antikonceptiva mindre effektive.
Concurrent use of antibiotics with oral contraceptives may render oral contraceptives less effective.
Glukuronidering og renal udskillelse af uændret tigecyclin er de sekundære veje.
Glucuronidation and renal excretion of unchanged tigecycline are secondary routes.
Bivirkningsprofilen for tigecyclin hos disse 25 forsøgspersoner var generelt i overensstemmelse med bivirkningsprofilen hos voksne.
The adverse reaction profile of tigecycline in these 25 subjects was generally consistent with that in adults.
Der var ingen klinisk relevante forskelle i tigecyclins clearance hos mænd og kvinder.
There were no clinically relevant differences in the clearance of tigecycline between men and women.
Parenterale produkter skal efterses visuelt for partikler og misfarvning (f.eks. grøn eller sort) før administration.
Parenteral products should be inspected visually for particulate matter and discolouration (e.g., green or black) prior to administration.
Tigecyclins plasmaproteinbinding in vitro går fra ca. 71 % til 89 % ved koncentrationer, som blev observeret i kliniske forsøg (0,1-1,0 mikrog/ml).
The in vitro plasma protein binding of tigecycline ranges from approximately 71 % to 89 % at concentrations observed in clinical studies (0.1 to 1.0 mcg/ml).
Hud og subkutane væv pruritus, udslæt svære hudreaktioner, herunder StevensJohnson syndrom
Skin and subcutaneous tissue disorders pruritus, rash severe skin reactions, including Stevens-Johnson Syndrome
Der er ikke udført livstidsforsøg med dyr til evaluering af tigecyclins karcinogenicitet, men korttidsgenotoksicitetsforsøg med tigecyclin var negative.
Lifetime studies in animals to evaluate the carcinogenic potential of tigecycline have not been performed, but short-term genotoxicity studies of tigecycline were negative.
• Fortæl det straks til lægen, hvis De får symptomer på overfølsomhed.
• Tell your doctor immediately if you develop symptoms of an allergic reaction.
Samtidig administration af tigecyclin og warfarin (enkeltdosis på 25 mg) til raske forsøgspersoner viste et fald i clearance af R-warfarin og S-warfarin på 40 % og 23 % og en stigning i AUC på henholdvis 68 % og 29 %.
Concomitant administration of tigecycline and warfarin (25 mg single-dose) to healthy subjects resulted in a decrease in clearance of R-warfarin and S-warfarin by 40 % and 23 %, and an increase in AUC by 68 % and 29 %, respectively.
Hætteglasset indeholder i gennemsnit 6 % overskud.
Note: The vial contains a 6 % overage.
Der er kun meget begrænsede sikkerhedsdata fra 2 farmakokinetiske studier (se pkt.
Very limited safety data were available from two PK studies (see section 5.2).
Ved alvorlig nedsat nyrefunktion var AUC 30% højere end hos personer med normal nyrefunktion (se pkt.
In severe renal impairment, AUC was 30 % higher than in subjects with normal renal function (see section 4.2).
Den nedsatte følsomhed i begge grupper er blevet tilskrevet overekspression af den ikke-specifikke AcrAB-efflukspumpe til flere lægemidler.
Decreased susceptibility in both groups has been attributed to the overexpression of the non-specific AcrAB multi-drug efflux pump.
Hætteglasset skal skvulpes forsigtigt, indtil det aktive stof er opløst.
The vial should be gently swirled until the active substance is dissolved.
Tigecyclins clearance forventes derfor ikke at blive påvirket af aktive stoffer, som hæmmer eller inducerer aktiviteten af disse CYP450 isoformer (se pkt.
Therefore, clearance of tigecycline is not expected to be affected by active substances that inhibit or induce the activity of the CYP450 isoforms.
Polymikrobiale intraabdominale infektioner har dog responderet på behandling med tigecyclin i kliniske undersøgelser.
However, polymicrobial intra-abdominal infections have shown to respond to treatment with tigecycline in clinical trials.
Den anbefalede tigecyclin-dosis påvirkede ikke hastigheden eller omfanget af absorptionen og heller ikke clearance af digoxin (0,5 mg efterfulgt af 0,25 mg dagligt), når lægemidlet blev administreret til raske voksne.
Tigecycline in recommended dosage did not affect the rate or extent of absorption, or clearance of digoxin (0.5 mg followed by 0.25 mg daily) when administered in healthy adults.
Når pulveret er opløst og fortyndet og er klar til brug, skal det anvendes med det samme.
Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately.
Invitro er tigecyclin hverken en kompetitiv eller irreversibel inhibitor af CYP450 enzymer (se pkt.
In vitro, tigecycline is neither a competitive inhibitor nor an irreversible inhibitor of CYP450 enzymes (see section 5.2).
Dosis normaliseret til 1 mg/kg gennemsnit ± SD tigecyclin Cmax og AUC til børn Alder (år)
Dose Normalized to 1 mg/kg Mean ± SD Tigecycline Cmax and AUC in Children Age (yr)
Steady state AUC0-12 t var 2349850 ng•t/ml.
The steady-state AUC0-12h was 2349±850 ng•h/ml.
Der skal tages en beslutning om, hvorvidt amningen skal afbrydes, eller om tigecyclin-behandlingen skal seponeres/undgås, idet der tages højde for barnets fordele ved amningen og kvindens fordele ved tigecyclin-behandlingen.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tigecycline therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Brug ikke Tygacil efter den udløbsdato, der står på pakningen.
Do not use this medicine after the expiry date which is stated on the vial.
Dyreforsøg har påvist reproduktiv toksicitet (se pkt.
Studies in animals have shown reproductive toxicity (see section 5.3).
I alle Fase 3 og Fase 4 (cSSTI- og cIAI) forsøg døde 2,4 % (54 ud af 2.216) af de patienter, som fik tigecyclin, og 1,7 % (37 ud af 2.206) af de patienter, som fik aktive komparatorer.
In all Phase 3 and 4 (cSSTI and cIAI) studies, death occurred in 2.4 % (54/2216) of patients receiving tigecycline and 1.7% (37/2206) of patients receiving active comparators.
Diagnosen akut pankreatitis bør overvejes hos patienter i tigecyclinbehandling, som udvikler kliniske symptomer, tegn eller unormale laboratorieværdier, som kunne tyde på akut pankreatitis.
The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis.
• Hvis De har eller tidligere har haft bivirkninger som følge af antibiotika tilhørende tetracyklinklassen (f.eks. øget følsomhed i huden over for sollys, misfarvning under tandudviklingen, betændelse i bugspytkirtlen og ændring af visse laboratorieværdier ved måling af blodets størkningsevne).
• If you have or previously had any side effects due to antibiotics belonging to the tetracycline class (e.g., skin sensitization to sun light, staining on developing teeth, pancreas inflammation, and alteration of certain laboratory values aimed at measuring how well your blood clots).
• Lavt indhold af fibrinogen i blodet (et protein, der medvirker til blodets størkning).
• Low fibrinogen levels in the blood (a protein involved in blood clotting)
Medfødt resistente organismer
Inherently resistant organisms
Tigecyclin, som er et glycylcyklinantibiotikum, hæmmer proteintranslation i bakterier ved at binde sig til den 30S-ribosomale subenhed og blokere tilførslen af amino-acyl-tRNA-molekyler til ribosomets A-site.
Tigecycline, a glycylcycline antibiotic, inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome.
C-mærket tigecyclin angiver, at tigecyclin nemt udskilles via mælken hos lakterende rotter.
C-labelled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats.
Denne in vitro information stemmer overens med den manglende effekt af tigecyclin på digoxin-clearance, som blev set i in vivo interaktionsstudiet beskrevet overfor (se pkt.
This in vitro information is consistent with the lack of effect of tigecycline on digoxin clearance noted in the in vivo drug interaction study described above (see section 4.5).
Der blev ikke fundet evidens på lysfølsomhed hos rotter efter administration af tigecyclin.
No evidence of photosensitivity was observed in rats following administration of tigecycline.
Patienter med svær grundsygdom, f.eks. patienter med svækket immunforsvar, patienter med liggesårsinfektioner eller patienter med infektioner, som krævede over 14 dages behandling (f.eks. nekrotiserende fasciitis), blev ikke inkluderet.
Patients with severe underlying disease, such as those that were immunocompromised, patients with decubitus ulcer infections, or patients that had infections requiring longer than 14 days of treatment (for example, necrotizing fasciitis), were not enrolled.
Hvis der identificeres et infektionsfokus ud over cSSTI eller cIAI efter initieret behandling med tigecyclin, skal det overvejes at påbegynde anden antibakteriel behandling, som har vist sig at være effektiv til behandling af den specifikke infektionstype.
If a focus of infection other than cSSTI or cIAI is identified after initiation of tigecycline therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Tigecyclin skal administeres intravenøst via en bestemt slange eller via et Y-site.
Tigecycline should be administered intravenously through a dedicated line or through a Y-site.
Tigecyclins systemiske clearance blev imidlertid reduceret med 25 % og 55%, og tigecyclins halveringstid blev forlænget med 23 % og 43% hos patienter med henholdsvis moderat til svært nedsat leverfunktion (Child Pugh B og C) (se pkt.
However, systemic clearance of tigecycline was reduced by 25 % and 55 % and the half-life of tigecycline was prolonged by 23 % and 43 % in patients with moderate or severe hepatic impairment (Child Pugh B and C), respectively (see section 4.2).
Klinisk helbredelse, mITT-population 0,75 mg/kg 1 mg/kg
Clinical Cure, mITT Population 0.75 mg/kg
• Blodforgiftning (alvorlig infektion i kroppen og blodbanen), septisk shock (alvorlig tilstand som kan føre til svigt af mange organer og død som følge af blodforgiftning)
• Sepsis (severe infection in the body and blood stream)/septic shock (serious medical condition which can lead to multiple organ failure and death as a result of sepsis)
I kliniske, farmakologiske undersøgelser med anvendelse af det terapeutiske dosisregime på 100 mg fulgt af 50 mg/12 timer var serum tigecyclin steady state Cmax 866233 ng/ml for 30 minutters infusioner og 63497 ng/ml for 60 minutters infusioner.
In clinical pharmacology studies using the therapeutic dosage regimen of 100 mg followed by 50 mg q12h, serum tigecycline steady-state Cmax was 866±233 ng/ml for 30-minute infusions and 634±97 ng/ml for 60-minute infusions.
Tigecyclins farmakokinetiske tilbøjelighed efter en enkelt dosis blev ikke ændret hos patienter med nedsat nyrefunktion (kreatininclearance < 30 ml/min., n=6).
The single dose pharmacokinetic disposition of tigecycline was not altered in patients with renal insufficiency (creatinine clearance 30 ml/min, n=6).
Der er forekommet akut pankreatitis, som kan være alvorlig (hyppighed: ikke almindelig), i forbindelse med tigecyclinbehandling (se pkt.
Acute pancreatitis, which can be serious, has occurred (frequency: uncommon) in association with tigecycline treatment (see section 4.8).
Tilgængelige farmakodynamiske/toksikologiske data fra dyr har påvist udskillelse af tigecyclin/metabolitter i mælk (se pkt.
Available pharmacodynamic/toxicological data in animals have shown excretion of tigecycline/metabolites in milk (see section 5.3).
Intravenøs bolusadministration af tigecyclin er blevet forbundet med histaminrespons i dyreforsøg.
Bolus intravenous administration of tigecycline has been associated with a histamine response in animal studies.
De hyppigste lægemiddelrelaterede bivirkninger, opstået under behandling, i kliniske forsøg var reversibel kvalme (21 %) og opkastning (13 %), som ofte viste sig tidligt (på 1.-2. behandlingsdag) og som generelt var lette eller moderate i sværhedsgrad.
In clinical trials, the most common medicinal product-related treatment emergent adverse reactions were reversible nausea (21 %) and vomiting (13 %), which usually occurred early (on treatment days 1-2) and were generally mild or moderate in severity.
Hvis De er allergisk over for antibiotika i tetracyklingruppen (f.eks. minocyklin, doxycyklin etc.), er De måske allergisk over for tigecyclin.
If you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Hvis De får diaré under eller efter behandlingen med Tygacil, skal De straks kontakte lægen.
If you develop diarrhoea during or after your treatment, tell your doctor at once.
Et dosisregime med 1,2 mg/kg tigecyclin hver 12. time (til en maksimumdosis på 50 mg hver 12. time) for børn i alderen 8 til <12 år og med 50 mg hver 12. time for unge i alderen 12 til <18 år vil sandsynligvis give eksponeringer, der er sammenlignelige med eksponeringer observeret hos voksne, der behandles efter det godkendte dosisregime.
A dosing regimen of 1.2 mg/kg of tigecycline every 12 hours (to a maximum dose of 50 mg every 12 hours) for children aged 8 to <12 years and of 50 mg every 12 hours for adolescents aged 12 to <18 years would likely result in exposures comparable to those observed in adults treated with the approved dosing regimen.
Under behandling med Tygacil
During treatment with Tygacil:
Men eftersom tigecyclin muligvis forlænger både protrombintiden (PT) og den aktiverede partielle tromboplastintid (aPTT), skal de relevante koagulationstest monitoreres nøje, når tigecyclin administreres samtidigt med antikoagulantia (se pkt.
However, since tigecycline may prolong both prothrombin time (PT) and activated partial thromboplastin time (aPTT), the relevant coagulation tests should be closely monitored when tigecycline is co-administered with anticoagulants (see section 4.4).
Følgende aktive stoffer må ikke administreres samtidigt via det samme Y-site som tigecyclin: Amfotericin B, amfotericin B lipidkompleks, diazepam, esomeprazol, omeprazol og intravenøse opløsninger, som kunne resultere i en stigning i pH til over 7.
The following active substances should not be administered simultaneously through the same Y-site as tigecycline: Amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole, omeprazole and intravenous solutions that could result in an increase of pH above 7.
Der blev ikke observeret nogen overordnede forskelle i farmakokinetikken mellem raske ældre forsøgspersoner og unge forsøgspersoner (se pkt.
No overall differences in pharmacokinetics were observed between healthy elderly subjects and younger subjects (see section 4.2).
In-vitro studier i humane levermikrosomer indikerer, at tigecyclin ikke hæmmer metaboliseringen medieret af nogle af følgende 6 CYP- isoformer: 1A2, 2C8, 2C9, 2C19, 2D6 og 3A4 ved kompetitiv hæmning.
In vitro studies in human liver microsomes indicate that tigecycline does not inhibit metabolism mediated by any of the following 6 cytochrome P450 (CYP) isoforms: 1A2, 2C8, 2C9, 2C19, 2D6, and 3A4 by competitive inhibition.
Tygacil kan forårsage bivirkninger som svimmelhed.
Tygacil may cause side effects such as dizziness.
• Lægen vil overvåge Dem nøje for at se, om De udvikler andre infektioner.
• Your doctor will monitor you closely for the development of any other bacterial infections.
• Dårlig eller langsom sårheling
• Poor or slow wound healing
• Fortæl det straks til lægen, hvis De får stærke mavesmerter, kvalme og opkastning.
• Tell your doctor immediately if you develop severe abdominal pain, nausea, and vomiting.
• Nedsat indhold af protein i blodet.
• Low protein levels in the blood
Der er påvist krydsresistens mellem tigecyclin og minocyklinresistente isolater blandt Enterobacteriaceae på grund af multistof-resistens-efflukspumper.
Cross-resistance between tigecycline and minocycline-resistant isolates among the Enterobacteriaceae due to multi-drug resistance (MDR) efflux pumps has been shown.
Metabolisme og ernæring hypoglykæmi, hypoproteinæmi
Metabolism and nutrition disorders hypoglycaemia, hypoproteinaemia
Resultater fra dyreforsøg angiver, at tigecyclin passerer placenta og findes i føtalt væv.
Results of animal studies indicate that tigecycline crosses the placenta and is found in foetal tissues.
I kliniske forsøg med komplicerede hud- og bløddelsinfektioner (cSSTI), komplicerede intraabdominale infektioner (cIAI), diabetiske fodinfektioner, nosokomiel pneumoni og forsøg med resistente patogener er der observeret en numerisk højere mortalitetsrate hos patienter, som fik tigecyclin, i forhold til patienter i behandling med komparator.
In clinical studies in complicated skin and soft tissue infections (cSSTI), complicated intra-abdominal infections (cIAI), diabetic foot infections, nosocomial pneumonia and studies in resistant pathogens, a numerically higher mortality rate among tigecycline treated patients has been observed as compared to the comparator treatment.
Generelt er tigecyclins primære eliminationsvej galden til udskillelse af uændret tigecyclin.
Overall, the primary route of elimination for tigecycline is biliary excretion of unchanged tigecycline.
Sådan får De Tygacil i denne indlægsseddel).
How Tygacil is given in this leaflet)
Bivirkninger ved antibiotikaklassen
Antibiotic class effects
Øvrige indholdsstoffer: Lactosemonohydrat, saltsyre og natriumhydroxid.
The other ingredients are lactose monohydrate, hydrochloric acid, and sodium hydroxide.
Der foreligger også begrænset erfaring med behandling af patienter med samtidig bakteriæmi (5,6 %).
Limited experience is also available in treating patients with concurrent bacteraemia (5.6 %).
Der blev inkluderet et begrænset antal patienter med komorbide faktorer, f.eks. diabetes (25,8 %), perifer vaskulær sygdom (10,4 %), intravenøst stofmisbrug (4,0 %) og positiv HIV-infektion (1,2 %).
A limited number of patients were enrolled with co-morbid factors such as diabetes (25.8 %), peripheral vascular disease (10.4 %), intravenous substance abuse (4.0 %), and HIVpositive infection (1.2 %).
Der foreligger rapporter om pseudomembranøs colitis i forbindelse med næsten alle antibakterielle midler, og sygdommen kan variere i sværhedsgrad fra mild til livstruende.
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening.
In vitro studier med Caco-2-celler indikerede, at tigecyclin ikke hæmmer digoxin-passagen, hvilket tyder på, at tigecyclin ikke er en P-glykoprotein-(P-gp-) hæmmer.
In vitro studies using Caco-2 cells indicate that tigecycline does not inhibit digoxin flux, suggesting that tigecycline is not a P-glycoprotein (P-gp) inhibitor.
Tigecyclin er sårbart over for kromosomalt indkodede multistof-efflukspumper for Proteeae og Pseudomonas aeruginosa.
Tigecycline is vulnerable to chromosomally-encoded multi-drug efflux pumps of Proteeae and Pseudomonas aeruginosa.
Undersøgelser forhøjet amylase i serum, øget urinkvælstof (BUN)
Investigations elevated amylase in serum, increased blood urea nitrogen (BUN)
Kvalme og opkastning er meget almindelige bivirkninger hos børn og unge (se pkt.
Nausea and vomiting are very common adverse reactions in children and adolescents (see section 4.8).
• Udslæt, som kan føre til svær blæredannelse og afskalning af huden (Stevens-Johnsons syndrom)
• Skin rash, which may lead to severe blistering and peeling of the skin (Stevens-Johnson
Svimmelhed kan forekomme, og dette kan have indflydelse på evnen til at føre bil eller betjene maskiner (se pkt.
Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Der blev oftere rapporteret om abnorme ASAT- og ALAT-værdier hos tigecyclin-behandlede patienter i perioden efter behandling end hos de patienter, som blev behandlet med komparator, hvilket oftere fandt sted under behandling.
AST and ALT abnormalities in tigecycline-treated patients were reported more frequently in the post therapy period than in those in comparator-treated patients, which occurred more often on therapy.
Ældre Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
Elderly No dosage adjustment is necessary in elderly patients (see section 5.2).
Hvert hætteglas indeholder lactosemonohydrat.
Each vial contains lactose monohydrate.
Kontakt lægen eller sundhedspersonalet, før De bruger Tygacil
Talk to your doctor or nurse before receiving Tygacil:
Pulveret skal blandes i hætteglasset med en lille smule opløsning.
The powder should be mixed in the vial with a small amount of solution.
Et begrænset antal patienter med svær grundsygdom, f.eks. patienter med svækket immunforsvar, patienter med APACHE II-scorer > 15 (3,3 %) eller multiple intraabdominale abscesser (11,4 %), som var synlige ved kirurgisk indgreb.
There were a limited number of patients with severe underlying disease such as immunocompromised patients, patients with APACHE II scores  15 (3.3 %), or with surgically apparent multiple intra-abdominal abscesses (11.4 %).
I kliniske forsøg med patienter med cIAI er dårlig heling af operationssår blevet forbundet med superinfektion.
In clinical trials in cIAI patients, impaired healing of the surgical wound has been associated with superinfection.
patienter med en vægt  125 kg. AUC var 24 % lavere hos patienter, der vejede  125 kg. Der findes ingen data for patienter, der vejer 140 kg og derover.
Clearance, weight-normalised clearance, and AUC were not appreciably different among patients with different body weights, including those weighing ≥125 kg. AUC was 24 % lower in patients weighing ≥125 kg. No data is available for patients weighing 140 kg and more.
Ligesom andre antibiotika i tetracyklinklassen inducerer tigecyclin muligvis også permanente tanddefekter (misfarvning og emaljedefekter) og en forsinket ossifikation hos fostre, som eksponeres in utero i den sidste halvdel af gestationen, samt hos børn under otte år på grund af berigelsen i væv med en høj calciumomsætning og dannelsen af calcium-kelatkomplekser (se pkt.
As it is known for tetracycline class antibiotics, tigecycline may also induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses, exposed in utero during the last half of gestation, and in children under eight years of age due to the enrichment in tissues with a high calcium turnover and formation of calcium chelate complexes (see section 4.4).
Tygacil forårsager muligvis fosterskader.
Tygacil may cause foetal harm.
Pseudomembranøs kolit kan opstå ved brug af de fleste antibiotika, herunder Tygacil.
Pseudomembranous colitis may occur with most antibiotics including Tygacil.
Der foreligger også begrænset erfaring med behandling af patienter med samtidig bakteriæmi (3,4 %).
Limited experience is also available in treating patients with concurrent bacteraemia (3.4 %).
Det skal nøje overvejes at anvende kombinations-antibakteriel terapi, hvis tigecyclin administreres til alvorligt syge patienter med cIAI sekundært til klinisk tydelig tarmperforation eller patienter med begyndende sepsis eller septisk shock (se pkt.
Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with cIAI secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock (see section 4.8).