natgillin/translations-raw huggingface dataset:
Ældre (≥65 år) Dosisjustering er ikke nødvendig til patienter ≥65 år (se pkt.
Elderly (≥ 65 years) No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2).
Der er ikke gennemført specifikke studier med dialysepatienter.
No dedicated studies in dialysis patients have been conducted.
Oritavancin 46,6 μg/ml påvirkede ikke en test for aktiveret protein C-resistens (APCR) in vitro, hvilket tyder på, at sandsynligheden for, at oritavancin vil interferere med denne test, er lav.
oritavancin 46.6 μg/mL did not affect an assay for activated protein C resistance (APCR), suggesting that there is a low likelihood that oritavancin will interfere with this test.
• Leveren producerer flere enzymer (påvises i blodprøver)
• More enzymes produced by your liver (as shown in blood tests);
Det blev påvist, at oritavancin var en uspecifik, svag hæmmer (CYP2C9 og CYP2C19) eller en svag inducer (CYP3A4 og CYP2D6) af flere CYP-isoformer.
Oritavancin was found to be a nonspecific, weak inhibitor (CYP2C9 and CYP2C19) or a weak inducer (CYP3A4 and CYP2D6) of several CYP isoforms.
• har eller har mistanke om at have en knogleinfektion, der skyldes bakterier (osteomyelitis).
• have or are suspected to have a bone infection caused by bacteria (osteomyelitis).
Desuden indicerede in vitro-studier i humane lever-mikrosomer, at oritavancin ikke metaboliseres.
Additionally, in vitro human liver microsome studies indicated that oritavancin is not metabolized.
I de to større ABSSSI-studier var de behandlede infektionstyper begrænset til cellulitis, abscesser og sårinfektioner.
In the two major trials in ABSSSI the types of infections treated were confined to cellulitis, abscesses and wound infections only.
• Hurtig eller svag puls
• Rapid or weak pulse;
1.200 mg administreret som en enkelt dosis ved intravenøs infusion over 3 timer.
1,200 mg administered as a single dose by intravenous infusion over 3 hours.
Den fortyndede opløsning skal anvendes straks.
The diluted solution should be used immediately.
Der skal bruges poser af PP (polypropylen) eller PVC (polyvinylklorid) til klargøring af administrationen.
PP (Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration preparation.
Hvis du skal have et blodfortyndende lægemiddel, der kaldes ufraktioneret heparin, skal du fortælle det til lægen, hvis du har fået Orbactiv inden for de sidste 5 dage (120 timer).
If you are going to be given a blood thinner called unfractionated heparin, then tell your doctor if you have received Orbactiv within the last 5 days (120 hours).
Kvindelige patienter rapporterede bivirkninger hyppigere end mandlige patienter.
Female patients had a higher reporting rate for adverse reactions than male patients.
Der er begrænsede erfaringer fra kliniske studier hos patienter med bakteriæmi, perifer vaskulær sygdom eller neutropeni, hos patienter med nedsat immunforsvar, hos patienter over 65 år samt med infektioner forårsaget af S. pyogenes.
There is limited experience in clinical studies in patients with bacteraemia, peripheral vascular disease or neutropenia, in immunocompromised patients, in patients aged > 65 years and in infections due to S. pyogenes.
I det kliniske program med 3.017 oritavancin-behandlede patienter var der ikke evidens for utilsigtet overdosering af oritavancin.
In the clinical programme of 3,017 oritavancin-treated subjects; there was no incidence of accidental overdose of oritavancin.
Efter en enkelt intravenøs infusion til diegivende rotter blev radioaktivt mærket [14C]oritavancin udskilt i mælk og absorberet af diende unger.
Following a single intravenous infusion in lactating rats, radio-labelled [14C]oritavancin was excreted in milk and absorbed by nursing pups.
Derfor bør der ikke tilsættes andre stoffer, additiver eller andre lægemidler blandet i en natriumchloridopløsning til intravenøs brug til oritavancin hætteglas til engangsbrug eller infunderes samtidig via samme i.v.-slange eller via en fælles i.v.-port.
Therefore, other substances, additives or other medicinal products mixed in sodium chloride solution for intravenous use should not be added to oritavancin single-use vials or infused simultaneously through the same intravenous line or through a common intravenous port.
Det skal du vide, før du får Orbactiv 3.
What you need to know before you are given Orbactiv 3.
Der skal anvendes aseptiske procedurer til klargøring Orbactiv.
Aseptic procedures should be used for the preparation of Orbactiv.
Natriumchloridinfusionsvæske må ikke bruges til fortynding, da det er uforligeligt med oritavancin og kan forårsage udfældning af lægemidlet.
Sodium chloride solution should not be used for dilution as it is incompatible with oritavancin and may cause precipitation of the medicinal product.
APCR-testen er imidlertid en fosfolipid-baseret test, og det kan ikke udelukkes, at de højere oritavancinkoncentrationer, der kan forekomme ved klinisk anvendelse, kan påvirke denne test.
However, APCR is a phospholipid-based test and it cannot be ruled out that higher concentrations of oritavancin that may occur during clinical use could interfere with this test.
Det er derfor vigtigt at overveje denne diagnose hos patienter, der debuterer med diarré efter administration af oritavancin (se pkt.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of oritavancin (see section 4.8).
Desuden kan lægemidler med en basisk eller neutral pH være uforligelige med oritavancin (se pkt.
In addition, medicinal products formulated at a basic or neutral pH may be incompatible with oritavancin (see section 6.6).
- Øvrige indholdsstoffer: mannitol og phosphorsyre.
- The other ingredients are mannitol and phosphoric acid.
Mortalitet blev observeret hos nyfødte rotter ved lidt lavere dosisniveauer end hos voksne.
Mortality was observed in neonatal rats at slightly lower dosage levels than in adults.
• har eller formodes at have en smertefuld ansamling pus i huden (absces).
• have or are suspected to have a painful collection of pus on your skin (abscess).
Der er ikke udført levetidsstudier hos dyr med henblik på vurdering af oritavancins karcinogenicitet.
Lifetime studies in animals have not been conducted to evaluate the carcinogenic potential of oritavancin.
Eksponeringen (AUC0-24) af oritavancin i væsken i blærer på huden var 20 % af eksponeringen i plasma efter en enkelt dosis på 800 mg hos raske patienter.
Exposures (AUC0-24) of oritavancin in skin blister fluid were 20% of those in plasma after a single 800 mg dose in healthy subjects.
Der er ikke påvist klinisk virkning over for følgende patogener, selvom in vitro-studier tyder på, at de ville være følsomme for oritavancin i fravær af erhvervede modstandsmekanismer:
Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to oritavancin in the absence of acquired mechanisms of resistance:
• Forhøjet urinsyreniveau i blodet
• High uric acid levels in the blood;
• Betændelse omkring en sene (tenosynovitis)
• Inflammation surrounding a tendon (known as tenosynovitis);
Resistens over for oritavancin blev observeret in vitro hos vancomycin-resistente isolater af Staphylococcus aureus.
Resistance to oritavancin was observed in vitro in vancomycin-resistant isolates of Staphylococcus aureus.
Oritavancin har 3 virkningsmekanismer: (I) hæmning af transglykosylationstrinnet (polymerisation) i cellevæggens biosyntese ved binding til stampeptidet i forstadiet til peptidoglycan, (II) hæmning af transpeptidationtrinnet (tværbinding) i cellevæggens biosyntese ved binding til cellevæggens peptidforbindende segmenter samt (III) forstyrrelse af bakteriemembranens integritet, hvilket fører til depolarisering, permeabilisering samt hurtig celledød.
Oritavancin has three mechanisms of action: (i) inhibition of the transglycosylation (polymerization) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors; (ii) inhibition of the transpeptidation (crosslinking) step of cell wall biosynthesis by binding to the peptide bridging segments of the cell wall; and (iii) disruption of bacterial membrane integrity, leading to depolarization, permeabilization, and rapid cell death.
Et standardbatteri af in vitro- og in vivo-tests af det genotoksiske potentiale viste ingen klinisk relevante resultater.
A standard battery of in vitro and in vivo tests on the genotoxic potential did not reveal any clinically relevant findings.
Påvirkningens varighed
Duration of interference
Patienter bør monitoreres tæt for tegn på toksicitet eller manglende virkning, hvis de har fået oritavancin, mens de får et potentielt interagerende lægemiddel (f.eks. bør patienter monitoreres for blødning, hvis de får oritavancin og warfarin samtidig) (se pkt.
Patients should be closely monitored for signs of toxicity or lack of efficacy if they have been given oritavancin while on a potentially affected compound (e.g. patients should be monitored for bleeding, if concomitantly receiving oritavancin and warfarin) (see section 4.4).
For en sikkerheds skyld bør oritavancin undgås under graviditet, medmindre den potentielle fordel berettiger den potentielle risiko for fosteret.
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.
- Aktivt stof: oritavancin.
- The active substance is oritavancin.
Leukocytoklastisk vaskulitis, angioødem, erytema multiforme, ansigtsrødme
Leucocytoclastic vasculitis, angioedema, erythema multiforme, flushing
Antibakteriel virkning over for andre relevante patogener
Antibacterial activity against other relevant pathogens
Orbactiv kan kun anvendes til behandling af infektioner, der skyldes bakterier, der kaldes grampositive bakterier.
Orbactiv can only be used to treat infections caused by bacteria known as Gram positive bacteria.
Der blev ikke observeret metabolitter i plasma eller galde hos hhv. oritavancin-behandlede hunde og rotter.
No metabolites were observed in plasma or bile from oritavancin treated dogs and rats, respectively.
Fortyndet Russell Viper venom-tid (DRVVT)
Dilute Russell's viper venom time (DRVVT)
- Orbactiv fås i kartoner med 3 hætteglas.
- Orbactiv is available in cartons containing 3 vials.
Histaminlignende infusionsreaktioner, der opstod straks eller kort tid efter administration af oritavancin, forekom hos både rotter og hunde.
Histamine-like infusion reactions following immediately or shortly after dosing with oritavancin occurred in both rats and dogs.
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).
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).
Eksponeringen hos rotter ved NOAEL var mindre til kun lidt højere end eksponeringen hos mennesker baseret på AUC.
The exposure in rats at the NOAEL was less to only slightly higher than the human exposure based on the AUC.
Oritavancin udviser lineær farmakokinetik ved en dosis på op til 1.200 mg.
Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg.
Grampositive mikroorganismer
Gram-positive microorganisms:
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).
Oritavancin concentrations achieved in the blood after 1,200 mg doses may produce falsely elevated results from certain laboratory tests (see Table 1).
Oritavancin påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Oritavancin has a minor influence on the ability to drive and use machines.
- Orbactiv er et pulver til koncentrat til infusionsvæske, opløsning - Orbactiv er et hvid til offwhite pulver, leveret i et 50 ml hætteglas af glas.
- 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.
• Nedsat antal blodplader (under den normale nedre grænse - trombocytopeni).
• Reduced blood platelet count below the normal lower limit (known as thrombocytopenia).
Før anvendelse af oritavancin er det vigtigt at forhøre sig omhyggeligt om tidligere overfølsomhedsreaktioner på glykopeptider (f.eks. vancomycin, telavancin).
Before using oritavancin it is important to inquire carefully about previous hypersensitivity reactions to glycopeptides (e.g. vancomycin, telavancin).
Tabel 1: Koagulationstest, der påvirkes af oritavancin Test
Table 1: Coagulation tests affected by oritavancin Assay
• Aktiveret koagulationstid (ACT) i op til 24 timer
• Activated Clotting Time (ACT) for up to 24 hours,
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.
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.
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.
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.
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.
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.
Aktiveret partiel tromboplastintid (aPTT)
Activated partial thromboplastin time (aPTT)
Eksponeringen hos rotter ved NOAEL (No Observed Adverse Effect Level) var mindre til kun lidt højere end eksponeringen hos mennesker baseret på AUC.
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.
Når oritavancin blev administreret intravenøst i doser på op til 30 mg/kg, påvirkede det ikke han- og hunrotters fertilitet eller reproduktionsevne.
When administered intravenously at doses up to 30 mg/kg, oritavancin did not affect the fertility or reproductive performance of male and female rats.
Rekonstitution: Der skal anvendes aseptisk teknik til rekonstitution af 3 Orbactiv hætteglas, 400 mg.
Reconstitution: Aseptic technique should be used to reconstitute three Orbactiv 400 mg vials.
De tilgængelige farmakodynamiske/toksikologiske data fra dyrestudier viser, at oritavancin udskilles i mælk (se pkt.
Available pharmacodynamic/toxicological data in animals have shown excretion of oritavancin in milk (see section 5.3).
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.
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).
• Diarré
• Diarrhoea;
Protrombintid (PT)
Prothrombin time (PT)
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.
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.
S. anginosus, S. intermedius, og S. constellatus)
• Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Moderate, dosisrelaterede stigninger i leverenzymer (ALAT og ASAT) blev observeret hos rotter og hunde og blev påvist at være reversible ved seponering af behandlingen.
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.
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.
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.
• Rødme i ansigtet og på overkroppen, nældefeber, kløe og/eller hududslæt (red man-syndrom)
• Flushing of the face and upper body, hives, itching and/or rashes (red man syndrome) • Wheezing;
Gramnegative organismer er reelt resistente over for alle glykopeptider, herunder oritavancin.
Gram-negative organisms are intrinsically resistant to all glycopeptides, including oritavancin.
Resultaterne viste, at oritavancin ikke havde nogen indvirkning på S-warfarins AUC og Cmax.
The results showed no effect of oritavancin on Swarfarin AUC and Cmax.
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.
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.
På grund af mulighed for krydsallergi skal patienter med overfølsomhed over for glykopeptider i anamnesen monitoreres omhyggeligt under og efter infusionen.
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.
Tabel 3: Følsomhedsinterpretive kriterier for oritavancin Organismegruppe
Susceptibility Interpretive Criteria for Oritavancin Organism group
- 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.
- 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.
Der findes ingen data om krydsreaktivitet mellem oritavancin og andre glykopeptider, herunder vancomycin.
No data are available on cross-reactivity between oritavancin and other glycopeptides, including vancomycin.
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.
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.
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.
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.
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.
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.
Oritavancin udviser reduceret in vitro-aktivitet over for visse grampositive organismer af arten Lactobacillus, Leuconostoc og Pediococcus, der er reelt resistente over for glykopeptider.
Oritavancin exhibits reduced in vitro activity against certain Gram-positive organisms of the genera Lactobacillus, Leuconostoc and Pediococcus that are intrinsically resistant to glycopeptides.
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.
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.
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.
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).
Der er rapporteret alvorlige overfølsomhedsreaktioner, herunder anafylaktiske reaktioner og anafylaktisk shock i forbindelse med brug af oritavancin.
Serious hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock have been reported with the use of oritavancin.
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.
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.
Der var ingen evidens for transplacental overførsel af oritavancin hos drægtige rotter.
There was no evidence of transplacental transfer of oritavancin in pregnant rats.
Oritavancin fjernes ikke fra blodet ved hæmodialyse.
Oritavancin is not removed from blood by haemodialysis procedures.
Mannitol Phosphorsyre
Mannitol Phosphoric acid
Din læge eller sygeplejerske vil give dig Orbactiv gennem et drop (infusion) i en blodåre.
Orbactiv will be given to you by your doctor or nurse, by infusion (drip) into a vein.
Orbactiv kan give svimmelhed, hvilken kan påvirke din evne til at køre bil eller betjene maskiner.
Orbactiv may cause dizziness, which can influence your ability to drive or operate machines.
I tilfælde af overdosering skal der gives passende støttende behandling.
In the event of overdose, supportive measures should be taken.
Orbactiv bør klargøres med aseptisk teknik på et apotek.
Orbactiv should be prepared under aseptic techniques in a pharmacy.
En populationsfarmakokinetisk analyse indicerede, at nedsat nyrefunktion ikke havde nogen klinisk relevant virkning på eksponeringen for oritavancin.
Population pharmacokinetic analysis indicated that renal impairment had no clinically relevant effect on the exposure of oritavancin.