FrancophonIA/ELRC3.0 huggingface dataset:
English: 2.5 ml twice daily 2.5 ml once daily
Danish: 5 ml to gange daglig 5 ml én gang daglig
English: Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce.
Danish: F.eks. chokolade- eller kirsebærsirup , og dessertsauce såsom karamelsauce Eller du kan tilberede sukkervand: Bland en teskefuld vand med trekvart (3/4) teskefuld sukker).
English: 5 ml once daily
Danish: 1,5 ml én gang daglig
English: 10 ml twice daily
Danish: 2,0 ml to gange daglig
English: Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce.
Danish: F.eks. chokolade- eller kirsebærsirup, og dessertsauce såsom karamelsauce Eller du kan tilberede sukkervand: Bland en teskefuld vand med trekvart (3/4) teskefuld sukker).
English: 4.3 ml twice daily 4.3 ml once daily
Danish: 4,3 ml én gang daglig
English: 3.5 ml twice daily 3.5 ml once daily
Danish: 3,5 ml én gang daglig
English: vertigo), Fatigue, Pyrexia , Pain in limb
Danish: Smerter, svimmelhed (herunder vertigo), træthed, pyreksi, ekstremitetssmerter
English: 5 ml twice daily
Danish: 2,5 ml to gange daglig
English: 15 kg up to 23 kg 45 mg
Danish: 15 kg op til 23 kg
English: - Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.
Danish: - Aktivt stof: Hver kapsel indeholder oseltamivirphosphat svarende til 45 mg oseltamivir.
English: 10 ml once daily
Danish: 3,0 ml én gang daglig
English: Capsule shell Gelatin
Danish: Mave-tarm-kanalen Opkastning
English: Date of first authorisation: 19/03/2015 Date of latest renewal: 13/01/2020
Danish: Dato for første markedsføringstilladelse: 19/03/2015 Dato for seneste fornyelse: 13/01/2020
English: Other side effects occur with the following frequencies:
Danish: Andre bivirkninger forekommer med følgende hyppigheder:
English: International normalized ratio (INR)
Danish: International normaliseret ratio (INR)
English: • Pain or irritation where the injection was given;
Danish: • Smerter eller irritation, hvor injektionen blev givet
English: S=Susceptible, R=Resistant
Danish: F=Følsom, R=Resistent
English: A risk to the newborns/infants cannot be excluded.
Danish: En risiko for ammede nyfødte/spædbørn kan ikke udelukkes.
English: Other types of infections have not been studied.
Danish: Der er ikke undersøgt andre typer infektioner.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheder er defineret som følger: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) eller ikke kendt (kan ikke estimeres ud fra de tilgængelige data).
English: • Decrease in blood pressure (which could make you feel faint or dizzy).
Danish: • Fald i blodtrykket (som kan gøre dig svag eller svimmel).
English: Orbactiv should not to be used in children or adolescents below the age of 18.
Danish: Orbactiv bør ikke anvendes til børn og unge under 18 år.
English: • Low blood sugar;
Danish: • Lavt blodsukker
English: The use of antibacterial medicinal products may increase the risk of overgrowth of non-susceptible micro-organisms.
Danish: Anvendelse af antibakterielle lægemidlerkan øge risikoen for overvækst af ikke-følsomme mikroorganismer.
English: It is for use in adults only.
Danish: Det er kun beregnet til voksne.
English: Effects of age, weight, gender and race
Danish: Virkninger af alder, vægt, køn and etnicitet
English: Oritavancin is approximately 85% bound to human plasma proteins.
Danish: Oritavancin er ca. 85 % bundet til humane plasmaproteiner.
English: 20060 Masate (MI) Italy
Danish: 20060 Masate (MI) Italien
English: Red man syndrome
Danish: Red man-syndrom
English: The safety and efficacy of oritavancin in children and adolescents (<18 years) have not yet been established.
Danish: Oritavancins sikkerhed og virkning hos børn og unge (<18 år) er endnu ikke klarlagt.
English: Oritavancin is given via intravenous infusion over 3 hours to minimise the risk of infusion related reactions.
Danish: Oritavancin gives via intravenøs infusion over 3 timer for at minimere risiko for infusionsrelaterede reaktioner.
English: • have developed severe diarrhoea during or following antibiotic treatment in the past.
Danish: • tidligere har fået svær diarré under eller efter behandling med antibiotika
English: This leaflet was last revised in: Other sources of information
Danish: Denne indlægsseddel blev senest ændret Andre informationskilder
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages hensyn til officielle retningslinjer for korrekt anvendelse af antibakterielle midler.
English: In a population PK analysis, a relationship between height and clearance was identified, where clearance increased with increasing height.
Danish: I en populations-PK-analyse blev der identificeret et forhold mellem højde og clearance, hvor clearance øgedes i takt med stigende højde.
English: - if you are allergic to oritavancin or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for oritavancin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: You should not be given this medicine during pregancy unless the benefit is considered to be greater than the risk to the baby.
Danish: Du må ikke få dette lægemiddel under graviditet, medmindre fordelen anses for at være større end risikoen for barnet.
English: No mass balance study has been conducted in humans.
Danish: Der er ikke gennemført et massebalancestudie hos mennesker.
English: Tell your doctor or nurse immediately if you experience a reaction to the infusion including any of the following symptoms:
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis du oplever en reaktion på infusionen, herunder et eller flere af følgende symptomer:
English: Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of ill effects.
Danish: Din læge beslutter, hvordan du skal behandles, og vil bl.a. stoppe behandlingen og overvåge dig for tegn på skadelige virkninger.
English: After being given Orbactiv, you may get a new infection at another site on your skin.
Danish: Når du har fået Orbactiv, kan du få en ny infektion et andet sted på huden.
English: • Accumulation of pus underneath the skin.
Danish: • Ansamling af pus under huden.
English: S ≤
Danish: F ≤
English: Oritavancin is a type of antibiotic (a lipoglycopeptide antibiotic) that can kill or stop the growth of certain bacteria.
Danish: Oritavancin er en type antibiotikum (et lipoglykopeptid-antibiotikum), der kan dræbe eller stoppe væksten af visse bakterier.
English: • Infection getting worse or new infection at another site on your skin;
Danish: • Forværring af infektionen eller ny infektion et andet sted på huden
English: If you experience these types of reactions, your doctor may decide to stop or slow the infusion.
Danish: Hvis du oplever disse typer reaktioner, kan lægen beslutte at standse infusionen eller nedsætte infusionshastigheden.
English: Patients should be monitored for signs and symptoms of osteomyelitis after administration of oritavancin.
Danish: Patienter skal monitoreres for tegn og symptomer på osteomyelitis efter administration af oritavancin.
English: It is unknown whether oritavancin/metabolites are excreted in human milk.
Danish: Det vides ikke, om oritavancin/metabolitter udskilles i human mælk.
English: While antibiotics, including Orbactiv, fight certain bacteria, they may not be active against other bacteria or fungi, which may, therefore, continue to grow.
Danish: Mens antibiotika, herunder også Orbactiv, bekæmper visse bakterier, kan det ske, at de ikke virker på andre bakterier eller svampe, som derfor kan blive ved med at vokse.
English: Dose modification based on height is not necessary.
Danish: Dosisjustering på basis af højde er ikke nødvendig.
English: In such a circumstance, the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered.
Danish: Supportive foranstaltninger samt administration af specifik behandling for Clostridioides difficile skal overvejes under disse omstændigheder.
English: What you need to know before you are given Orbactiv You must not be given Orbactiv
Danish: Det skal du vide, før du får Orbactiv Du må ikke få Orbactiv
English: Intravenous infusion over 3 hours (see section 6.6).
Danish: Intravenøs infusion over 3 timer (se pkt.
English: No dosage adjustment is warranted in these subpopulations.
Danish: Dosisjustering er ikke nødvendig hos disse underpopulationer.
English: Orbactiv is an antibiotic that contains the active substance oritavancin.
Danish: Orbactiv er et antibiotikum, der indeholder det aktive stof oritavancin.
English: Pharmacotherapeutic group: Antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA05
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, glykopeptid-antibiotika, ATC-kode: J01XA05
English: In mixed infections where other types of bacteria are suspected, your doctor will give you other appropriate antibiotics together with Orbactiv.
Danish: Ved blandede infektioner, hvor der er mistanke om andre typer bakterier, vil din læge give dig andre passende antibiotika sammen med Orbactiv.
English: Powder for concentrate
Danish: Pulver til koncentrat
English: The most commonly reported serious adverse reaction was cellulitis (1.1%).
Danish: Den hyppigst rapporterede alvorlige bivirkning var cellulitis (1,1 %).
English: • Swollen, red area of skin or underneath skin that feels hot and tender;
Danish: • Hævet, rødt område på huden eller under huden, der føles varmt og ømt
English: There are no or limited amount of data from the use of oritavancin in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af oritavancin til gravide kvinder.
English: • Silica Clot Time (SCT) for up to 18 hours, and
Danish: • Silica-aktiveret koagulationstid (SCT) i op til 18 timer, og
English: The most common reported reasons for discontinuation were cellulitis (0.4%) and osteomyelitis (0.3%).
Danish: De hyppigst rapporterede årsager til seponering var cellulitis (0,4 %) og osteomyelitis (0,3 %).
English: Parenteral medicinal products should be inspected visually for particulate matter after reconstitution.
Danish: Parenterale lægemidler skal inspiceres visuelt for partikler efter rekonstitution.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Danish: MIC-grænseværdier (Minimum inhibitory concentration) fastsat af EUCAST (European Committee on Antimicrobial Susceptibility Testing) er som følger:
English: How you will be given Orbactiv 4.
Danish: Sådan får du Orbactiv 4.
English: Studies in neonatal rats and dogs for 30 days showed the same tissue effects as those seen in adult animals including sensitivity to the oritavancin-mediated histamine-like infusion reactions.
Danish: Studier hos nyfødte rotter og hunde i 30 dage viste samme vævsvirkninger som dem, der ses hos voksne dyr, herunder følsomhed for oritavancin-medierede histaminlignende infusionsreaktioner.
English: • Dilute Russell's Viper Venom Test (DRVVT) for up to 72 hours.
Danish: • Fortyndet Russell Viper venom-test (DRVVT) i op til 72 timer.
English: Studies in pregnant rats and rabbits do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Studier med drægtige rotter og kaniner indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår drægtighed, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling.
English: Uncommon side effects (may affect up to 1 in 100 patients):
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter):
English: • PT and INR for up to 12 hours,
Danish: • PT og INR i op til 12 timer
English: • Swelling around throat or under the skin that develops over a short period of time;
Danish: • Hævelse omkring halsen eller under huden, der opstår i løbet af kort tid
English: Based on population PK analysis, the population mean total volume of distribution is estimated to be approximately 87.6 L, indicating oritavancin is extensively distributed into the tissues.
Danish: Ud fra populations-PK-analysen beregnes populationens gennemsnitlige totale fordelingsvolumen at være ca. 87,6 l, hvilket er tegn på, at oritavancin i udstrakt grad fordeles i vævet.
English: Concomitant use of warfarin
Danish: Samtidig brug af warfarin
English: Need for additional antibacterial agents
Danish: Behov for supplerende antibakterielle midler
English: Oritavancin concentrations that are found in the blood of patients following administration of a single dose have been shown to artificially prolong:
Danish: Det er vist, at oritavancin-koncentrationer, der findes i blodet hos patienter efter administration af en enkelt dosis, medfører kunstig forlængelse af:
English: Talk to your doctor or nurse before receiving Orbactiv if you:
Danish: Kontakt lægen eller sundhedspersonalet, før du får Orbactiv, hvis du:
English: If superinfection occurs, appropriate measures should be taken.
Danish: Hvis superinfektion forekommer, skal der træffes passende foranstaltninger.
English: If an acute hypersensitivity reaction occurs during oritavancin infusion, oritavancin should be discontinued immediately and appropriate supportive care should be instituted.
Danish: Hvis der forekommer en akut overfølsomhedsreaktion under en oritavancininfusion, skal infusionen straks afbrydes og passende støttende behandling iværksættes.
English: Cellulitis, abscess (limb and subcutaneous)
Danish: Cellulitis, absces (ekstremiteter og subkutan)
English: The area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC) ratio of oritavancin for the infecting organism has been shown to be the parameter that best correlates with efficacy.
Danish: Forholdet mellem arealet under koncentrationstidskurven (AUC) for oritavancin og MIC (Minimum Inhibitory Concentration) for den inficerende organisme er vist at være den parameter, der bedst korrelerer med virkningen.
English: MIC breakpoints (mg/L)
Danish: MIC-grænseværdier (mg/l)
English: Elderly (≥ 65 years) No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2).
Danish: Ældre (≥65 år) Dosisjustering er ikke nødvendig til patienter ≥65 år (se pkt.
English: No dedicated studies in dialysis patients have been conducted.
Danish: Der er ikke gennemført specifikke studier med dialysepatienter.
English: 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.
Danish: 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.
English: • More enzymes produced by your liver (as shown in blood tests);
Danish: • Leveren producerer flere enzymer (påvises i blodprøver)
English: Oritavancin was found to be a nonspecific, weak inhibitor (CYP2C9 and CYP2C19) or a weak inducer (CYP3A4 and CYP2D6) of several CYP isoforms.
Danish: Det blev påvist, at oritavancin var en uspecifik, svag hæmmer (CYP2C9 og CYP2C19) eller en svag inducer (CYP3A4 og CYP2D6) af flere CYP-isoformer.
English: • have or are suspected to have a bone infection caused by bacteria (osteomyelitis).
Danish: • har eller har mistanke om at have en knogleinfektion, der skyldes bakterier (osteomyelitis).
English: Additionally, in vitro human liver microsome studies indicated that oritavancin is not metabolized.
Danish: Desuden indicerede in vitro-studier i humane lever-mikrosomer, at oritavancin ikke metaboliseres.
English: In the two major trials in ABSSSI the types of infections treated were confined to cellulitis, abscesses and wound infections only.
Danish: I de to større ABSSSI-studier var de behandlede infektionstyper begrænset til cellulitis, abscesser og sårinfektioner.
English: • Rapid or weak pulse;
Danish: • Hurtig eller svag puls
English: 1,200 mg administered as a single dose by intravenous infusion over 3 hours.
Danish: 1.200 mg administreret som en enkelt dosis ved intravenøs infusion over 3 timer.
English: The diluted solution should be used immediately.
Danish: Den fortyndede opløsning skal anvendes straks.
English: PP (Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration preparation.
Danish: Der skal bruges poser af PP (polypropylen) eller PVC (polyvinylklorid) til klargøring af administrationen.
English: 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).
Danish: 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).
English: Female patients had a higher reporting rate for adverse reactions than male patients.
Danish: Kvindelige patienter rapporterede bivirkninger hyppigere end mandlige patienter.
English: 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.
Danish: 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.
English: In the clinical programme of 3,017 oritavancin-treated subjects; there was no incidence of accidental overdose of oritavancin.
Danish: I det kliniske program med 3.017 oritavancin-behandlede patienter var der ikke evidens for utilsigtet overdosering af oritavancin.
English: Following a single intravenous infusion in lactating rats, radio-labelled [14C]oritavancin was excreted in milk and absorbed by nursing pups.
Danish: Efter en enkelt intravenøs infusion til diegivende rotter blev radioaktivt mærket [14C]oritavancin udskilt i mælk og absorberet af diende unger.
English: 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.
Danish: 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.
English: What you need to know before you are given Orbactiv 3.
Danish: Det skal du vide, før du får Orbactiv 3.
English: Aseptic procedures should be used for the preparation of Orbactiv.
Danish: Der skal anvendes aseptiske procedurer til klargøring Orbactiv.
English: Sodium chloride solution should not be used for dilution as it is incompatible with oritavancin and may cause precipitation of the medicinal product.
Danish: Natriumchloridinfusionsvæske må ikke bruges til fortynding, da det er uforligeligt med oritavancin og kan forårsage udfældning af lægemidlet.
English: 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.
Danish: 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.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of oritavancin (see section 4.8).
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter, der debuterer med diarré efter administration af oritavancin (se pkt.
English: In addition, medicinal products formulated at a basic or neutral pH may be incompatible with oritavancin (see section 6.6).
Danish: Desuden kan lægemidler med en basisk eller neutral pH være uforligelige med oritavancin (se pkt.
English: - The other ingredients are mannitol and phosphoric acid.
Danish: - Øvrige indholdsstoffer: mannitol og phosphorsyre.
English: Mortality was observed in neonatal rats at slightly lower dosage levels than in adults.
Danish: Mortalitet blev observeret hos nyfødte rotter ved lidt lavere dosisniveauer end hos voksne.
English: • have or are suspected to have a painful collection of pus on your skin (abscess).
Danish: • har eller formodes at have en smertefuld ansamling pus i huden (absces).
English: Lifetime studies in animals have not been conducted to evaluate the carcinogenic potential of oritavancin.
Danish: Der er ikke udført levetidsstudier hos dyr med henblik på vurdering af oritavancins karcinogenicitet.
English: Exposures (AUC0-24) of oritavancin in skin blister fluid were 20% of those in plasma after a single 800 mg dose in healthy subjects.
Danish: 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.
English: 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:
Danish: 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:
English: • High uric acid levels in the blood;
Danish: • Forhøjet urinsyreniveau i blodet
English: • Inflammation surrounding a tendon (known as tenosynovitis);
Danish: • Betændelse omkring en sene (tenosynovitis)
English: Resistance to oritavancin was observed in vitro in vancomycin-resistant isolates of Staphylococcus aureus.
Danish: Resistens over for oritavancin blev observeret in vitro hos vancomycin-resistente isolater af Staphylococcus aureus.
English: 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.
Danish: 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.
English: A standard battery of in vitro and in vivo tests on the genotoxic potential did not reveal any clinically relevant findings.
Danish: Et standardbatteri af in vitro- og in vivo-tests af det genotoksiske potentiale viste ingen klinisk relevante resultater.
English: Duration of interference
Danish: Påvirkningens varighed
English: 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).
Danish: 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.