FrancophonIA/ELRC3.0 huggingface dataset:
English: As a precautionary measure, it is preferable to avoid the use of oritavancin during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Danish: For en sikkerheds skyld bør oritavancin undgås under graviditet, medmindre den potentielle fordel berettiger den potentielle risiko for fosteret.
English: - The active substance is oritavancin.
Danish: - Aktivt stof: oritavancin.
English: Leucocytoclastic vasculitis, angioedema, erythema multiforme, flushing
Danish: Leukocytoklastisk vaskulitis, angioødem, erytema multiforme, ansigtsrødme
English: Antibacterial activity against other relevant pathogens
Danish: Antibakteriel virkning over for andre relevante patogener
English: Orbactiv can only be used to treat infections caused by bacteria known as Gram positive bacteria.
Danish: Orbactiv kan kun anvendes til behandling af infektioner, der skyldes bakterier, der kaldes grampositive bakterier.
English: No metabolites were observed in plasma or bile from oritavancin treated dogs and rats, respectively.
Danish: Der blev ikke observeret metabolitter i plasma eller galde hos hhv. oritavancin-behandlede hunde og rotter.
English: Dilute Russell's viper venom time (DRVVT)
Danish: Fortyndet Russell Viper venom-tid (DRVVT)
English: - Orbactiv is available in cartons containing 3 vials.
Danish: - Orbactiv fås i kartoner med 3 hætteglas.
English: Histamine-like infusion reactions following immediately or shortly after dosing with oritavancin occurred in both rats and dogs.
Danish: Histaminlignende infusionsreaktioner, der opstod straks eller kort tid efter administration af oritavancin, forekom hos både rotter og hunde.
English: Therefore no dose adjustment is required, even if caution should be exercised when prescribing oritavancin to patients with severe hepatic impariment (Child-Pugh Class C).
Danish: Der er således ikke behov for at regulere dosis, selvom der skal udvises forsigtighed ved ordinering af oritavancin til patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: The exposure in rats at the NOAEL was less to only slightly higher than the human exposure based on the AUC.
Danish: Eksponeringen hos rotter ved NOAEL var mindre til kun lidt højere end eksponeringen hos mennesker baseret på AUC.
English: Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg.
Danish: Oritavancin udviser lineær farmakokinetik ved en dosis på op til 1.200 mg.
English: Gram-positive microorganisms:
Danish: Grampositive mikroorganismer
English: Oritavancin concentrations achieved in the blood after 1,200 mg doses may produce falsely elevated results from certain laboratory tests (see Table 1).
Danish: De oritavancinkoncentrationer, der findes i blodet efter administration af en dosis på 1.200 mg, kan give falsk forhøjede værdier i visse laboratorietest (se tabel 1).
English: Oritavancin has a minor influence on the ability to drive and use machines.
Danish: Oritavancin påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: - Orbactiv is a powder for concentrate for solution for infusion - Orbactiv is a white to off white powder, supplied in a 50 ml glass vial.
Danish: - Orbactiv er et pulver til koncentrat til infusionsvæske, opløsning - Orbactiv er et hvid til offwhite pulver, leveret i et 50 ml hætteglas af glas.
English: • Reduced blood platelet count below the normal lower limit (known as thrombocytopenia).
Danish: • Nedsat antal blodplader (under den normale nedre grænse - trombocytopeni).
English: Before using oritavancin it is important to inquire carefully about previous hypersensitivity reactions to glycopeptides (e.g. vancomycin, telavancin).
Danish: Før anvendelse af oritavancin er det vigtigt at forhøre sig omhyggeligt om tidligere overfølsomhedsreaktioner på glykopeptider (f.eks. vancomycin, telavancin).
English: Table 1: Coagulation tests affected by oritavancin Assay
Danish: Tabel 1: Koagulationstest, der påvirkes af oritavancin Test
English: • Activated Clotting Time (ACT) for up to 24 hours,
Danish: • Aktiveret koagulationstid (ACT) i op til 24 timer
English: Adverse reactions for oritavancin from the pooled Phase 3 ABSSSI clinical trials with single dose oritavancin are listed by system organ class in the following table.
Danish: Bivirkningerne i forbindelse med oritavancin fra de puljede kliniske fase 3 ABSSSI-studier med en enkelt dosis oritavancin er anført efter organsystemklasse i nedenstående tabel.
English: Oritavancin has been shown to artificially prolong prothrombin time (PT) and international normalised ratio (INR) for up to 12 hours, making the monitoring of the anticoagulation effect of warfarin unreliable up to 12 hours after an oritavancin dose.
Danish: Det er vist, at oritavancin forlænger protrombintid (PT) og international normaliseret ratio (INR) kunstigt i op til 12 timer, således at monitorering af warfarins antikoagulerende virkning er upålidelig i op til 12 timer efter en dosis oritavancin.
English: S-warfarin pharmacokinetics were evaluated following a single dose of warfarin 25 mg given alone, or administered at the start, 24, or 72 hours after a single 1,200mg dose of oritavancin.
Danish: S-warfarins farmakokinetik blev vurderet efter en enkeltdosis warfarin på 25 mg givet alene eller administreret samtidigt med eller 24 eller 72 timer efter indgift af en enkeltdosis oritavancin på 1.200 mg.
English: Activated partial thromboplastin time (aPTT)
Danish: Aktiveret partiel tromboplastintid (aPTT)
English: The exposure in rats at the no observed adverse effect level (NOAEL) was less to only slightly higher than the human exposure based on the AUC.
Danish: Eksponeringen hos rotter ved NOAEL (No Observed Adverse Effect Level) var mindre til kun lidt højere end eksponeringen hos mennesker baseret på AUC.
English: When administered intravenously at doses up to 30 mg/kg, oritavancin did not affect the fertility or reproductive performance of male and female rats.
Danish: Når oritavancin blev administreret intravenøst i doser på op til 30 mg/kg, påvirkede det ikke han- og hunrotters fertilitet eller reproduktionsevne.
English: Reconstitution: Aseptic technique should be used to reconstitute three Orbactiv 400 mg vials.
Danish: Rekonstitution: Der skal anvendes aseptisk teknik til rekonstitution af 3 Orbactiv hætteglas, 400 mg.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of oritavancin in milk (see section 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyrestudier viser, at oritavancin udskilles i mælk (se pkt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with oritavancin 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 oritavancin i en eller flere undergrupper af den pædiatriske population ved behandling af akutte bakterielle infektioner i hud og hudstrukturer (se pkt.
English: • Diarrhoea;
Danish: • Diarré
English: Prothrombin time (PT)
Danish: Protrombintid (PT)
English: Population PK analysis from the single dose Phase 3 ABSSSI studies in patients indicated that gender, age, weight, or race had no clinically relevant effect on the exposure of oritavancin.
Danish: En populationsfarmakokinetisk analyse fra ABSSSI fase 3-studierne med en enkelt dosis til patienter indicerede, at køn, alder, vægt eller etnicitet ikke havde nogen klinisk relevant virkning på eksponeringen for oritavancin.
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Danish: S. anginosus, S. intermedius, og S. constellatus)
English: Moderate, dose-related increases in liver enzymes (alanine transaminase and aspartate transaminase) were observed in rats and dogs and were shown to be reversible upon cessation of treatment.
Danish: Moderate, dosisrelaterede stigninger i leverenzymer (ALAT og ASAT) blev observeret hos rotter og hunde og blev påvist at være reversible ved seponering af behandlingen.
English: Caution should be used when administering oritavancin concomitantly with medicinal products with a narrow therapeutic window that are predominantly metabolised by one of the affected CYP450 enzymes(e.g., warfarin), as co-administration may increase (e.g., for CYP2C9 substrates) or decrease (e.g., for CYP2D6 substrates) concentrations of the narrow therapeutic range medicinal product.
Danish: Oritavancin skal administreres med forsigtighed sammen med lægemidler med et smalt terapeutisk vindue, der hovedsageligt metaboliseres vha. af de påvirkede CYP-enzymer (f.eks. warfarin), eftersom samtidig administration kan øge (f.eks. for CYP2C9-substrater) eller reducere (f.eks. for CYP2D6substrater) koncentrationen af lægemidlet med det smalle terapeutiske område.
English: • Flushing of the face and upper body, hives, itching and/or rashes (red man syndrome) • Wheezing;
Danish: • Rødme i ansigtet og på overkroppen, nældefeber, kløe og/eller hududslæt (red man-syndrom)
English: Gram-negative organisms are intrinsically resistant to all glycopeptides, including oritavancin.
Danish: Gramnegative organismer er reelt resistente over for alle glykopeptider, herunder oritavancin.
English: The results showed no effect of oritavancin on Swarfarin AUC and Cmax.
Danish: Resultaterne viste, at oritavancin ikke havde nogen indvirkning på S-warfarins AUC og Cmax.
English: The pharmacokinetics of oritavancin were evaluated in a study of subjects with moderate hepatic impairment (Child-Pugh Class B, n=20) and compared with healthy subjects (n=20) matched for gender, age and weight.
Danish: Oritavancins farmakokinetik blev vurderet i et studie hos patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B, n=20) og sammenlignet med raske patienter (n=20) matchet med hensyn til køn, alder og vægt.
English: Due to the possibility of cross-hypersensitivity, there should be careful monitoring of patients with any history of glycopeptide hypersensitivity during and after the infusion.
Danish: På grund af mulighed for krydsallergi skal patienter med overfølsomhed over for glykopeptider i anamnesen monitoreres omhyggeligt under og efter infusionen.
English: Susceptibility Interpretive Criteria for Oritavancin Organism group
Danish: Tabel 3: Følsomhedsinterpretive kriterier for oritavancin Organismegruppe
English: - if it is expected that you may need to be given a blood thinning medicine (unfractionated heparin sodium) within 5 days (120 hours) of the dose of Orbactiv.
Danish: - hvis det forventes, at du kan få brug for at få et blodfortyndende lægemiddel (ufraktioneret heparinnatrium) inden for 5 dage (120 timer) efter, du har fået Orbactiv.
English: No data are available on cross-reactivity between oritavancin and other glycopeptides, including vancomycin.
Danish: Der findes ingen data om krydsreaktivitet mellem oritavancin og andre glykopeptider, herunder vancomycin.
English: The primary adverse effect of oritavancin administration to rats and dogs was a dose related accumulation of eosinophilic granules in tissue macrophages including hepatocytes, renal cortical epithelial cells, adrenal cells and macrophages of the reticulo endothelial system.
Danish: Den primære bivirkning ved administration af oritavancin til rotter og hunde var en dosisrelateret akkumulering af eosinofile granulater i vævsmakrofager, herunder hepatocytter, kortikale nyreepitelceller, binyreceller og makrofager i retikulo-endotelialsystemet.
English: The appearance of the eosinophilic granules did not occur following single dose administration and did not significantly affect innate macrophage function in vitro at intracellular levels anticipated from a single 1,200 mg dose.
Danish: Eosinofile granulater forekom ikke efter administration af en enkelt dosis og påvirkede ikke i væsentlig grad den medfødte makrofagfunktion in vitro på intracellulært plan, der kan forventes efter en enkelt dosis på 1.200 mg.
English: The pharmacokinetics of oritavancin in patients with severe hepatic impairment (Child-Pugh Class C) has not been evaluated, however based on pharmacokinetic parameters, severe hepatic impairment is not expected to have an impact on oritavancin exposure.
Danish: Farmakokinetikken for oritavancin hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C) er ikke vurderet; men ud fra de farmakokinetiske parametre forventes svært nedsat leverfunktion ikke have nogen indvirkning på eksponering for oritavancin.
English: Oritavancin exhibits reduced in vitro activity against certain Gram-positive organisms of the genera Lactobacillus, Leuconostoc and Pediococcus that are intrinsically resistant to glycopeptides.
Danish: Oritavancin udviser reduceret in vitro-aktivitet over for visse grampositive organismer af arten Lactobacillus, Leuconostoc og Pediococcus, der er reelt resistente over for glykopeptider.
English: Biochemistry changes associated with kidney function including decreases in urine-specific gravity and pH and slight increases in blood urea nitrogen and sporadic increases in creatinine were present in both rat and dog after treatment of two weeks.
Danish: Biokemiske ændringer associeret til nyrefunktionen, herunder fald i urinspecifik massefylde og pH samt små stigninger i BUN og sporadiske stigninger i kreatinin fandtes hos både rotter og hunde efter 2 ugers behandling.
English: Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours after oritavancin administration (see sections 4.4 and 4.5).
Danish: Intravenøs administration af ufraktioneret heparinnatrium er kontraindiceret i 120 timer (5 dage) efter administration af oritavancin, fordi testresultater for aktiveret partiel tromboplastintid (aPTT) kan være falsk forhøjede i op til 120 timer efter administration af oritavancin (se pkt.
English: Serious hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock have been reported with the use of oritavancin.
Danish: Der er rapporteret alvorlige overfølsomhedsreaktioner, herunder anafylaktiske reaktioner og anafylaktisk shock i forbindelse med brug af oritavancin.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from oritavancin 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 oritavancin skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: There was no evidence of transplacental transfer of oritavancin in pregnant rats.
Danish: Der var ingen evidens for transplacental overførsel af oritavancin hos drægtige rotter.
English: Oritavancin is not removed from blood by haemodialysis procedures.
Danish: Oritavancin fjernes ikke fra blodet ved hæmodialyse.
English: Mannitol Phosphoric acid
Danish: Mannitol Phosphorsyre
English: Orbactiv will be given to you by your doctor or nurse, by infusion (drip) into a vein.
Danish: Din læge eller sygeplejerske vil give dig Orbactiv gennem et drop (infusion) i en blodåre.
English: Orbactiv may cause dizziness, which can influence your ability to drive or operate machines.
Danish: Orbactiv kan give svimmelhed, hvilken kan påvirke din evne til at køre bil eller betjene maskiner.
English: In the event of overdose, supportive measures should be taken.
Danish: I tilfælde af overdosering skal der gives passende støttende behandling.
English: Orbactiv should be prepared under aseptic techniques in a pharmacy.
Danish: Orbactiv bør klargøres med aseptisk teknik på et apotek.
English: Population pharmacokinetic analysis indicated that renal impairment had no clinically relevant effect on the exposure of oritavancin.
Danish: En populationsfarmakokinetisk analyse indicerede, at nedsat nyrefunktion ikke havde nogen klinisk relevant virkning på eksponeringen for oritavancin.
English: Hypoglycaemia, hyperuricaemia
Danish: Hypoglykæmi, hyperurikæmi
English: This yields a concentration of 1.2 mg/mL of oritavancin.
Danish: Dette giver en koncentration på 1,2 mg oritavancin/ml.
English: Nausea, vomiting, diarrhoea, constipation
Danish: Kvalme, opkastning, diarré, obstipation
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, oritavancin should be coadministered with appropriate antibacterial agent(s).
Danish: Ved blandede infektioner, hvor der er mistanke om gramnegative og/eller visse anaerobe bakterier, skal oritavancin administreres sammen med et eller flere passende antibakterielle midler.
English: • aPTT for up to 120 hours,
Danish: • aPTT i op til 120 timer
English: • Higher than normal levels of eosinophils, a type of white blood cell (eosinophilia);
Danish: • Forhøjet antal eosinofiler (en type hvide blodlegemer) end normalt (eosinofili)
English: The most commonly reported adverse reactions (≥5%) were: nausea, hypersensitivity reactions,
Danish: De hyppigst rapporterede bivirkninger (≥5 %) var kvalme, overfølsomhedsreaktioner, reaktioner på infusionsstedet og hovedpine.
English: Infusion site reactions, including the following symptoms infusion site phlebitis, infusion site erythema, extravasation, induration, pruritis, rash, oedema peripheral
Danish: Reaktioner på infusionsstedet, herunder følgende symptomer: flebit på infusionsstedet, erytem på infusionsstedet, ekstravasation, induration, pruritus, hududslæt, perifert ødem
English: Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to oritavancin in vitro.
Danish: Kliniske studier har påvist virkning over for følgende patogener, der var følsomme for oritavancin in vitro.
English: Hypersensitivity (see sections 4.3 and 4.4) , anaphylactic reaction
Danish: 4.3 og 4.4), anafylaktisk reaktion
English: • Each vial should be swirled gently to avoid foaming and ensure that all Orbactiv powder is completely reconstituted in solution.
Danish: • Hvert hætteglas bør skvulpes forsigtigt for at undgå skumdannelse og sikre, at alt Orbactivpulver er helt opløst i koncentratet.
English: The Chromogenic Factor Xa Assay, the Thrombin Time (TT) assay and the assays used for the diagnosis of Heparin Induced Thrombocytopenia (HIT) are not affected by oritavancin.
Danish: Kromogen faktor Xa-test, trombintid (TT)-test og testene til diagnosticering af heparin-induceret trombocytopeni (HIT) påvirkes ikke af oritavancin.
English: In humans, less than 1% to 5% of the dose was recovered as parent drug in faeces and urine respectively after 2 weeks of collection indicating that oritavancin is slowly excreted unchanged.
Danish: Hos mennesker kunne mindre end 15 % af dosis måles som uomdannet stof i hhv. fæces og urin efter 2 ugers indsamling, hvilket er tegn på, at oritavancin udskilles langsomt og uomdannet.
English: Both the reconstituted solution and the diluted solution for infusion should be clear, colourless to pale yellow solution.
Danish: Både den rekonstituerede opløsning og den fortyndede infusionsvæske skal være en klar, farveløs til lysegul opløsning.
English: There is no known cross-resistance between oritavancin and non-glycopeptide classes of antibiotics.
Danish: Der er ingen kendt krydsresistens mellem oritavancin og non-glykopeptidantibiotika.
English: Orbactiv is used to treat infections of the skin and underlying tissues.
Danish: Orbactiv anvendes til behandling af hudinfektioner og infektioner i underliggende væv.
English: • Bone infection caused by bacteria (known as osteomyelitis);
Danish: • Knogleinfektion, der skyldes bakterier (osteomyelitis)
English: Mannitol Phosphoric acid (for pH-adjustment)
Danish: Mannitol Phosphorsyre (til regulering af pH)
English: Reconstitution:.
Danish: Rekonstitution:
English: Your doctor will treat you as necessary
Danish: Din læge vil behandle dig efter behov
English: It is particularly important to tell your doctor if you are using medicines that prevent blood from clotting (oral anticoagulants, e.g.coumarin anticoagulants ).
Danish: Det er især vigtigt at fortælle det til lægen, hvis du bruger medicin, der forhindrer blodet i at størkne (blodfortyndende lægemidler, der tages gennem munden, f.eks. blodfortyndende medicin med kumarin).
English: • Each vial should be swirled gently to avoid foaming and ensure that all of the powder is completely reconstituted in solution.
Danish: • Hvert hætteglas bør skvulpes forsigtigt for at undgå skumdannelse og sikre, at alt pulver er helt opløst i koncentratet.
English: The powder must be reconstituted with water for injections and the resulting concentrate must be diluted in a glucose 5% intravenous infusion bag prior to use.
Danish: Pulveret skal rekonstitueres med vand til injektioner og det resulterende koncentrat fortyndes i en i.v.infusionspose med glucose 5 % før anvendelse.
English: In the Phase 3 clinical trials, slightly more cases of newly emergent abscesses were reported in the oritavancin-treated arm than in the vancomycin-treated arm (4.6% vs 3.4%, respectively) (see section 4.8).
Danish: I de kliniske fase 3-studier blev der rapporteret lidt flere tilfælde af debuterende abscesser i oritavancin-armen end i vancomycin-armen (hhv. 4,6 % vs. 3,4 %) (se pkt.
English: This histopathological finding correlated with an enlargement and an increase in the weight of the spleen.
Danish: Dette histopatologiske fund var korreleret til en forstørret og tungere milt.
English: Intravenous infusions of oritavancin can cause reactions that resemble “red man syndrome”, including flushing of the upper body, urticaria, pruritis and/or rash.
Danish: Intravenøse infusioner af oritavancin kan forårsage reaktioner, der ligner ”red mansyndrom”, herunder hudrødmen på overkroppen, urticaria, pruritus og/eller hududslæt.
English: If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C for Orbactiv diluted in glucose 5% intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis opløsningen ikke anvendes straks, er opbevaringstid og -forhold før anvendelse brugerens eget ansvar og bør normalt ikke overskride 12 timer ved 25 °C og 24 timer ved 2-8 °C for Orbactiv fortyndet i en i.v.-infusionspose med glucose 5 %, medmindre rekonstitution og fortynding er blevet foretaget under kontrollerede og validerede aseptiske forhold.
English: Contents of the pack and other information What Orbactiv contains
Danish: Pakningsstørrelser og yderligere oplysninger Orbactiv indeholder:
English: Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin.
Danish: Hvert hætteglas indeholder oritavancin-diphosphat svarende til 400 mg oritavancin.
English: Up to 18 hours
Danish: Op til 18 timer
English: • have ever had an allergic reaction to another glycopeptide antibiotic (such as vancomycin and telavancin)
Danish: • nogensinde har haft en allergisk reaktion på et andet glykopeptid antibiotikum (f.eks.
English: Intravenous infusions of Orbactiv can cause flushing of the upper body, hives, itching and/or rashes.
Danish: Intravenøse infusioner af Orbactiv kan give hudrødme på overkroppen, nældefeber, kløe og/eller hududslæt.
English: The recommended dose for Orbactiv is one single infusion of 1,200 mg administered into a vein over 3 hours.
Danish: Den anbefalede dosis Orbactiv er én enkelt infusion på 1.200 mg, der gives i en blodåre i løbet af 3 timer.