FrancophonIA/ELRC3.0 huggingface dataset:
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you or your child. - Keep this leaflet.
Danish: Læs denne indlægsseddel grundigt, inden De eller Deres barn begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: The use of tigecycline may result in overgrowth of non-susceptible organisms, including fungi.
Danish: Brugen af tigecyclin kan forårsage overvækst af ikke-følsomme organismer, herunder svampe.
English: Blood and lymphatic system disorders prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT)
Danish: Blod- og lymfesystem forlænget aktiveret partiel thromboplastintid (aPTT), forlænget prothrombintid (PT)
English: cIAI cSSTI Overall
Danish: cIAI cSSTI Samlet
English: Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis.
Danish: Det bør overvejes at stoppe behandlingen med tigecyclin i de tilfælde, hvor udvikling af pankreatitis kan mistænkes.
English: No data are available on whether tigecycline can cross the blood-brain barrier in humans.
Danish: Der foreligger ingen data om, hvorvidt tigecyclin kan krydse blodhjernebarrieren hos mennesker.
English: Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting.
Danish: Intravenøs administration af tigecyclin ved en enkelt dosis på 300 mg i løbet af 60 minutter hos raske frivillige resulterede i en øget forekomst af kvalme og opkastning.
English: For instructions on reconstitution & dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution og fortynding af lægemidlet før administration, se pkt.
English: The summary of clinical response in the modified intent-to-treat (mITT) population results is shown in the following table.
Danish: Resultaterne af det kliniske respons hos mITT-populationen (den modificerede intent to treat-population) er sammenfattet i nedenstående tabel.
English: Enterobacter aerogenes
Danish: Enterobacter aeroganes
English: Your doctor will monitor you closely for any potential infections and treat you if necessary.
Danish: Lægen vil kontrollere, om De har andre infektioner, og behandle Dem, hvis det er nødvendigt.
English: Experience in the use of tigecycline for treatment of infections in patients with severe underlying diseases is limited.
Danish: Erfaringen med brug af tigecyclin til behandling af infektioner hos patienter med alvorlige underliggende sygdomme er begrænset.
English: The duration of therapy should be guided by the severity, site of the infection, and the patient's clinical response.
Danish: Behandlingsvarigheden afhænger af infektions sværhedsgrad, infektionsstedet og patientens kliniske respons.
English: Cardiac Electrophysiology
Danish: Kardial elektrofysiologi
English: Infections and infestations sepsis/septic shock, pneumonia, abscess, infections
Danish: Infektioner og parasitære sygdomme sepsis/septisk shock, pneumoni, absces, infektioner
English: Indication n/N (%)
Danish: Indikation n/N (%)
English: There are no or limited amount of data from the use of tigecycline in pregnant women.
Danish: Der foreligger ingen eller kun en begrænset mængde data med anvendelsen af tigecyclin til gravide.
English: Therefore, no dosage adjustment is necessary when tigecycline is administered with digoxin.
Danish: Det er derfor ikke nødvendigt at foretage dosisjustering, når tigecyclin administreres samtidigt med digoxin.
English: Not known side effects are (frequency cannot be estimated from the available data):
Danish: Bivirkninger, hvis hyppighed ikke kendes, er (hyppigheden kan ikke estimeres ud fra de forhåndenværende data):
English: Higher Cmax values than in adult patients were observed in several children in these studies.
Danish: Hos flere børn i disse studier blev der observeret højere Cmax-værdier end hos voksne patienter.
English: These vials are distributed to the hospital in a ten tray pack.
Danish: Disse hætteglas leveres til hospitalet i en pakke med 10 hætteglas.
English: Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines, ATC code: J01AA12.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, tetracycliner, ATC-kode: J01AA12.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibacterial agent (see section 4.8).
Danish: Det er derfor vigtigt at tage højde for denne diagnose hos patienter med diarré, som er opstået under eller efter administration af et hvilket som helst antibakterielt middel (se pkt.
English: Thus, 5 ml of reconstituted solution is equivalent to 50 mg of the active substance.
Danish: Derfor svarer 5 ml opløsning til 50 mg af det aktive stof.
English: Read the package leaflet before use for directions on reconstitution and dilution.
Danish: Læs indlægssedlen inden brug for vejledning om opløsning og fortynding.
English: Decreased susceptibility in Acinetobacter baumannii has been attributed to the overexpression of the AdeABC efflux pump.
Danish: Nedsat følsomhed over for Acinetobacter baumannii er blevet tilskrevet overekspression af AdeABC efflukspumpen.
English: Therefore, patients presenting with cholestasis should be closely monitored.
Danish: Patienter med kolestase skal derfor monitoreres nøje.
English: • If you are allergic to tigecycline, or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis De er allergisk over for tigecyclin eller et af de øvrige indholdsstoffer i Tygacil (angivet i afsnit 6).
English: Patients usually improve after tigecycline discontinuation.
Danish: Patienterne får det almindeligvis bedre efter ophør med tigecyclin.
English: Tigecycline has decreased in vitro activity against Proteus, Providencia, and Morganella spp.
Danish: ^)Tigecyclin har nedsat in vitro aktivitet over for Proteus, Providencia og Morganella spp.
English: For intravenous use after reconstitution and dilution.
Danish: Til intravenøs brug efter opløsning og fortynding.
English: Streptococcus anginosus group* (includes S. anginosus, S. intermedius and S. constellatus) Streptococcus pyogenes*
Danish: * (herunder S. anginosus, S. intermedius and S. constellatus) Streptococcus pyogenes*
English: This prevents incorporation of amino acid residues into elongating peptide chains.
Danish: Dette forhindrer inkorporeringen af aminosyre-rester i forlængede peptidkæder.
English: Tigecycline is able to overcome the two major tetracycline resistance mechanisms, ribosomal protection and efflux.
Danish: Tigecyclin er i stand til at overvinde de to store tetracyklinresistensmekanismer, ribosomal beskyttelse og effluks.
English: These effects were observed at exposures of 14 and 3 times the human daily dose based on the AUC in rats and dogs respectively.
Danish: Disse effekter blev observeret ved eksponeringer, som lå 14 og 3 gange højere end den daglige humandosis, baseret på AUC hos henholdsvis rotter og hunde.
English: Significant differences in sepsis/septic shock with tigecycline (2.2 %) vs comparators (1.1 %) were observed.
Danish: Der blev observeret signifikante forskelle i sepsis/septisk shock med tigecyclin (2,2 %) i forhold til komparatorer (1,1 %).
English: In humans, the steady-state volume of distribution of tigecycline averaged 500 to 700 L (7 to 9 L/kg), indicating that tigecycline is extensively distributed beyond the plasma volume and concentrates into tissues.
Danish: Hos mennesker lå tigecyclins gennemsnitlige distributionsvolumen ved steady state på 500-700 l (7-9 l/kg), hvilket angiver, at tigecyclin fordeles i stort omfang ud over plasmavolumen og koncentreres i væv.
English: The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide.
Danish: PH-værdien justeres med saltsyre og om nødvendigt med natriumhydroxid.
English: In addition, tigecycline did not show NADPH-dependency in the inhibition of CYP2C9, CYP2C19, CYP2D6 and CYP3A, suggesting the absence of mechanism-based inhibition of these CYP enzymes.
Danish: Derudover viste tigecyclin ingen NADPH-afhængighed ved hæmning af CYP2C9, CYP2C19, CYP2D6 og CYP3A, hvilket tyder på, at der ikke er nogen mekanismebaseret hæmning af disse CYP enzymer.
English: Liver function tests, coagulation parameters, haematology parameters, amylase and lipase should be monitored prior to treatment initiation with tigecycline and regularly while on treatment.
Danish: Leverfunktion, koagulationsparametre, hæmatologiske parametre, amylase og lipase skal monitoreres inden initiering af behandling med tigecyclin samt regelmæssigt under behandlingen.
English: Population PK analysis of both studies identified body weight as a covariate of tigecycline clearance in children aged 8 years and older.
Danish: Den farmakokinetiske populationsanalyse i begge studier identificerede kropsvægt som en kovariant for tigecyclin-clearance hos børn i alderen 8 år og opefter.
English: • If you have poor or slow wound healing.
Danish: • Hvis De har dårlig eller langsom sårheling.
English: No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion (Child Pugh A og Child Pugh B).
English: As a consequence, care should be paid to the rate of infusion of tigecycline in children and adolescents.
Danish: Der skal derfor udvises omhu med hensyn til infusionshastigheden af tigecyclin hos børn og unge.
English: 1 mg/kg 1.25 mg/kg
Danish: 1,25 mg/kg
English: At 4 times the minimum inhibitory concentration (MIC), a 2-log reduction in colony counts was observed with tigecycline against Enterococcus spp., Staphylococcus aureus, and Escherichia coli.
Danish: Ved 4 gange den mindste hæmmende koncentration (MIC) blev der observeret en 2-log-reduktion i kolonitællinger med tigecyclin til behandling af Enterococcus spp., Staphylococcus aureus og Escherichia coli.
English: Consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in the nursing pups as a result of exposure via maternal milk.
Danish: I overensstemmelse med tigecyclins begrænsede orale biotilgængelighed sker der kun lille eller ingen systemisk eksponering for tigecyclin hos de diende unger på grund af eksponering via modermælk.
English: It is unknown whether tigecycline/metabolites are excreted in human milk.
Danish: Det er ukendt, om tigecyclin/metabolitter udskilles i human mælk.
English: There is no target-based cross-resistance between tigecycline and most classes of antibiotics.
Danish: Der er ingen målbaseret krydsresistens mellem tigecyclin og de fleste antibiotikaklasser.
English: Tygacil is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.
Danish: Tygacil er et antibiotikum tilhørende glycylcyklingruppen, som virker ved at stoppe den bakterievækst, der forårsager infektioner.
English: Concurrent use of antibiotics with oral contraceptives may render oral contraceptives less effective.
Danish: Samtidig brug af antibiotika og perorale antikonceptiva kan gøre perorale antikonceptiva mindre effektive.
English: Glucuronidation and renal excretion of unchanged tigecycline are secondary routes.
Danish: Glukuronidering og renal udskillelse af uændret tigecyclin er de sekundære veje.
English: The adverse reaction profile of tigecycline in these 25 subjects was generally consistent with that in adults.
Danish: Bivirkningsprofilen for tigecyclin hos disse 25 forsøgspersoner var generelt i overensstemmelse med bivirkningsprofilen hos voksne.
English: There were no clinically relevant differences in the clearance of tigecycline between men and women.
Danish: Der var ingen klinisk relevante forskelle i tigecyclins clearance hos mænd og kvinder.
English: Parenteral products should be inspected visually for particulate matter and discolouration (e.g., green or black) prior to administration.
Danish: Parenterale produkter skal efterses visuelt for partikler og misfarvning (f.eks. grøn eller sort) før administration.
English: 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).
Danish: Tigecyclins plasmaproteinbinding in vitro går fra ca. 71 % til 89 % ved koncentrationer, som blev observeret i kliniske forsøg (0,1-1,0 mikrog/ml).
English: Skin and subcutaneous tissue disorders pruritus, rash severe skin reactions, including Stevens-Johnson Syndrome
Danish: Hud og subkutane væv pruritus, udslæt svære hudreaktioner, herunder StevensJohnson syndrom
English: Lifetime studies in animals to evaluate the carcinogenic potential of tigecycline have not been performed, but short-term genotoxicity studies of tigecycline were negative.
Danish: Der er ikke udført livstidsforsøg med dyr til evaluering af tigecyclins karcinogenicitet, men korttidsgenotoksicitetsforsøg med tigecyclin var negative.
English: • Tell your doctor immediately if you develop symptoms of an allergic reaction.
Danish: • Fortæl det straks til lægen, hvis De får symptomer på overfølsomhed.
English: 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.
Danish: 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 %.
English: Note: The vial contains a 6 % overage.
Danish: Hætteglasset indeholder i gennemsnit 6 % overskud.
English: Very limited safety data were available from two PK studies (see section 5.2).
Danish: Der er kun meget begrænsede sikkerhedsdata fra 2 farmakokinetiske studier (se pkt.
English: In severe renal impairment, AUC was 30 % higher than in subjects with normal renal function (see section 4.2).
Danish: Ved alvorlig nedsat nyrefunktion var AUC 30% højere end hos personer med normal nyrefunktion (se pkt.
English: Decreased susceptibility in both groups has been attributed to the overexpression of the non-specific AcrAB multi-drug efflux pump.
Danish: Den nedsatte følsomhed i begge grupper er blevet tilskrevet overekspression af den ikke-specifikke AcrAB-efflukspumpe til flere lægemidler.
English: The vial should be gently swirled until the active substance is dissolved.
Danish: Hætteglasset skal skvulpes forsigtigt, indtil det aktive stof er opløst.
English: Therefore, clearance of tigecycline is not expected to be affected by active substances that inhibit or induce the activity of the CYP450 isoforms.
Danish: Tigecyclins clearance forventes derfor ikke at blive påvirket af aktive stoffer, som hæmmer eller inducerer aktiviteten af disse CYP450 isoformer (se pkt.
English: However, polymicrobial intra-abdominal infections have shown to respond to treatment with tigecycline in clinical trials.
Danish: Polymikrobiale intraabdominale infektioner har dog responderet på behandling med tigecyclin i kliniske undersøgelser.
English: 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.
Danish: 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.
English: Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately.
Danish: Når pulveret er opløst og fortyndet og er klar til brug, skal det anvendes med det samme.
English: In vitro, tigecycline is neither a competitive inhibitor nor an irreversible inhibitor of CYP450 enzymes (see section 5.2).
Danish: Invitro er tigecyclin hverken en kompetitiv eller irreversibel inhibitor af CYP450 enzymer (se pkt.
English: Dose Normalized to 1 mg/kg Mean ± SD Tigecycline Cmax and AUC in Children Age (yr)
Danish: Dosis normaliseret til 1 mg/kg gennemsnit ± SD tigecyclin Cmax og AUC til børn Alder (år)
English: The steady-state AUC0-12h was 2349±850 ng•h/ml.
Danish: Steady state AUC0-12 t var 2349850 ng•t/ml.
English: 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.
Danish: 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.
English: Do not use this medicine after the expiry date which is stated on the vial.
Danish: Brug ikke Tygacil efter den udløbsdato, der står på pakningen.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktiv toksicitet (se pkt.
English: 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.
Danish: 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.
English: The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis.
Danish: Diagnosen akut pankreatitis bør overvejes hos patienter i tigecyclinbehandling, som udvikler kliniske symptomer, tegn eller unormale laboratorieværdier, som kunne tyde på akut pankreatitis.
English: • 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).
Danish: • 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).
English: • Low fibrinogen levels in the blood (a protein involved in blood clotting)
Danish: • Lavt indhold af fibrinogen i blodet (et protein, der medvirker til blodets størkning).
English: Inherently resistant organisms
Danish: Medfødt resistente organismer
English: 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.
Danish: 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.
English: C-labelled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats.
Danish: C-mærket tigecyclin angiver, at tigecyclin nemt udskilles via mælken hos lakterende rotter.
English: 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).
Danish: 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.
English: No evidence of photosensitivity was observed in rats following administration of tigecycline.
Danish: Der blev ikke fundet evidens på lysfølsomhed hos rotter efter administration af tigecyclin.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Tigecycline should be administered intravenously through a dedicated line or through a Y-site.
Danish: Tigecyclin skal administeres intravenøst via en bestemt slange eller via et Y-site.
English: 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).
Danish: 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.
English: Clinical Cure, mITT Population 0.75 mg/kg
Danish: Klinisk helbredelse, mITT-population 0,75 mg/kg 1 mg/kg
English: • 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)
Danish: • 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)
English: 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.
Danish: 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.
English: The single dose pharmacokinetic disposition of tigecycline was not altered in patients with renal insufficiency (creatinine clearance 30 ml/min, n=6).
Danish: Tigecyclins farmakokinetiske tilbøjelighed efter en enkelt dosis blev ikke ændret hos patienter med nedsat nyrefunktion (kreatininclearance < 30 ml/min., n=6).
English: Acute pancreatitis, which can be serious, has occurred (frequency: uncommon) in association with tigecycline treatment (see section 4.8).
Danish: Der er forekommet akut pankreatitis, som kan være alvorlig (hyppighed: ikke almindelig), i forbindelse med tigecyclinbehandling (se pkt.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tigecycline/metabolites in milk (see section 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra dyr har påvist udskillelse af tigecyclin/metabolitter i mælk (se pkt.
English: Bolus intravenous administration of tigecycline has been associated with a histamine response in animal studies.
Danish: Intravenøs bolusadministration af tigecyclin er blevet forbundet med histaminrespons i dyreforsøg.