FrancophonIA/ELRC3.0 huggingface dataset:
English: Residue depletion data was made available and supported a cattle meat and offal withdrawal period of 8 days and a cattle milk withdrawal period of 72 hours, as well as a horse meat and offal withdrawal period of 8 days following a single injection at the recommended dose of 0.06 mg dexamethasone per kg body weight.
Danish: Der blev forelagt restkoncentrationsdata, der støttede en tilbageholdelsestid for kød og indmad fra kvæg på 8 dage og en tilbageholdelsestid for mælk fra kvæg på 72 timer samt en tilbageholdelsestid for kød og indmad fra hest på 8 dage efter en enkelt injektion af den anbefalede dosis på 0,06 mg dexamethason/kg kropsvægt.
English: As there were no data available to support safe withdrawal periods for horse meat and offal following administration of high dosages in case of treatment of shock, the CVMP concluded that the shock indication in horses should be removed from the product information for Dexadreson and its generic products, where applicable.
Danish: Da der ikke forelå data til fastlæggelse af sikre tilbageholdelsestider for kød og indmad fra heste efter administration af høje doser til behandling af shock, konkluderede CVMP, at indikationen shock hos heste bør udgå af produktinformationen for Dexadreson og, i givet fald, for de tilsvarende generiske produkter.
English: Intervet Nederland B.V. p.o. box 50
Danish: p.o. box 50
English: • In the absence of residue depletion or pharmacokinetic data following a repeat treatment in cattle and horses for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that the advice on repeat dose treatment after 24-48 hours in cattle and horses should be removed from the product information;
Danish: • i mangel af restkoncentrationsdata ved den anbefalede gentagne dosering til kvæg og heste for Dexadreson, 2 mg/ml, og relaterede navne samt de tilsvarende generiske produkter fandt CVMP, at anvisningen om gentagen behandling efter 24-48 timer af kvæg og heste burde udgå af produktinformationen,
English: The same withdrawal period for edible tissues may be applied for cattle and horses for the same dosing regimen, resulting in a withdrawal period for horse meat and offal of 8 days for the single dose treatment of 0.06 mg dexamethasone per kg body weight.
Danish: Der kan anvendes samme tilbageholdelsestid for væv fra kvæg og heste ved samme doseringsregime, dvs. en tilbageholdelsestid for kød og indmad fra hest på 8 dage ved behandling med en enkelt dosis på 0,06 mg dexamethason/kg kropsvægt.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Danish: Ændringer til de relevante afsnit i produktresumé, etikettering og indlægsseddel
English: United Kingdom Eurovet Animal Health B.V. Handelsweg 25
Danish: Storbritannien Eurovet Animal Health B.V.
English: United Kingdom Dopharma Research B.V. Zalmweg 24
Danish: Storbritannien Dopharma Research B.V.
English: Belgium Eurovet Animal Health B.V. Handelsweg 25
Danish: Grækenland Eurovet Animal Health B.V.
English: Dopharma Research B.V. Zalmweg 24
Danish: Dopharma Research B.V.
English: Therefore, none of the studies was conducted at the maximum intended dose as requested in VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)1 and safe withdrawal periods in cattle tissues and milk can only be set for single treatment.
Danish: Ingen af undersøgelserne blev derfor udført ved den maksimale påtænkte dosis, således som det kræves i VICH GL48: Undersøgelser til vurdering af metabolisme og restkoncentrationskinetik af veterinærlægemidler i fødevareproducerende dyr:
English: Czech republic Intervet International B.V. Wim de Körverstraat 35
Danish: Wim de Körverstraat 35
English: Cattle, pigs, dogs and cats.
Danish: Kvæg, svin, hunde og katte.
English: Cattle, horses, goat, pigs, dogs and cats.
Danish: Kvæg, heste, geder, svin, hunde og katte.
English: Cattle, pigs, dogs and cats
Danish: Kvæg, svin, hunde og katte
English: Cattle, horses, goat, pigs, dogs and cats
Danish: Kvæg, heste, geder, svin, hunde og katte
English: It may harm them,
Danish: Sådan skal De tage DIFICLIR
English: DIFICLIR can be taken with or without food.
Danish: DIFICLIR kan tages med eller uden mad.
English: Elimination through urine is negligible (<1%).
Danish: Elimination via urinvejene er ubetydelig (<1 %).
English: You can take DIFICLIR before, during or after meals.
Danish: De kan tage DIFICLIR før, under og efter måltider.
English: This serious illness can result in painful, severe diarrhoea.
Danish: Denne alvorlige tilstand kan resultere i smertefuld, svær diarré.
English: Adults and elderly (≥65 years of age)
Danish: Voksne og ældre (≥ 65 år)
English: Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Danish: Der bør tages hensyn til officielle retningslinier vedrørende hensigtsmæssig brug af antibakterielle midler.
English: This difference is not considered clinically relevant.
Danish: Denne forskel anses ikke for at være klinisk relevant.
English: Swallow the tablets whole with a glass of water.
Danish: Tabletterne sluges hele sammen med et helt glas vand.
English: The bioavailability in humans is unknown.
Danish: Biotilgængeligheden hos mennesker er ukendt.
English: However, the potential for adverse reactions cannot be ruled out and general supportive measures are recommended.
Danish: Dog kan potentialet for bivirkninger ikke udelukkes, og der anbefales generelle understøttende foranstaltninger.
English: − decreased appetite
Danish: − Nedsat appetit
English: DIFICLIR should not be used in children or adolescents aged below 18 years as there is no information on this use in this population.
Danish: DIFICLIR bør ikke anvendes til børn og unge under 18 år, da der ikke foreligger information om brug hos denne population.
English: Antimicrobial spectrum
Danish: Antimikrobielt spektrum
English: Gender, weight and race
Danish: Køn, vægt og race
English: Do not take a double dose to make up for a forgotten dose.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen ”EXP” er den sidste dag i den nævnte måned.
English: In the pivotal clinical trials the rate of recurrence in the 30 days following treatment was assessed as a secondary endpoint.
Danish: I de afgørende kliniske forsøg blev recidivraten i de første 30 dage efter behandling vurderet som et sekundært endepunkt.
English: The half life of fidaxomicin is approximately 8-10 h.
Danish: Halveringstiden for fidaxomicin er ca. 8-10 timer.
English: Take the medicine pack with you so the doctor knows what you have taken.
Danish: Tag medicinpakningen med til lægen, så lægen ved præcis, hvad De har taget.
English: DIFICLIR blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking DIFICLIR.
Danish: Blodets indhold af DIFICLIR kan påvirkes af anden medicin De tager, og blodets indhold af anden medicin kan blive påvirket ved at tage DIFICLIR .
English: Other possible side effects are the following:
Danish: Af andre mulige bivirkninger kan nævnes:
English: If a severe allergic reaction occurs during treatment with DIFICLIR, the medicinal product should be discontinued and appropriate measures taken.
Danish: Hvis en alvorlig allergisk reaktion opstår under behandling med DIFICLIR, skal behandlingen afbrydes og passende foranstaltninger iværksættes.
English: Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet.
English: − If you are allergic to fidaxomicin or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis De er allergisk over for fidaxomicin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: There are no data available from the use of fidaxomicin in pregnant women.
Danish: Der er ingen tilgængelige data vedrørende brug af fidaxomicin til gravide kvinder.
English: Plasma levels appear to be elevated in the elderly (age ≥ 65 years).
Danish: Plasmaniveauer synes at være forhøjede hos ældre (≥65 år).
English: Your doctor will know whether your disease falls in the severe categories and will tell you whether this medicine is suitable for you.
Danish: Deres læge vil vide, om Deres sygdom hører til de svære kategorier, og vil fortælle Dem, om denne medicin er den rette behandling for Dem.
English: No dose adjustment is considered necessary.
Danish: Dosisjustering anses ikke for nødvendig.
English: Polyvinyl alcohol Titanium dioxide (E171) Talc
Danish: Polyvinylalkohol Titandioxid (E171)
English: If you stop taking this medicine too soon, the infection may come back.
Danish: Hvis De holder op med at tage medicinen tidligere end angivet i kuren, kan infektionen vende tilbage.
English: DIFICLIR works by killing the bacteria that cause the infection and helps to reduce the associated diarrhoea.
Danish: DIFICLIR virker ved at dræbe den bakterie, der er skyld i infektionen, og er med til at mindske den deraf følgende diarré.
English: Your doctor will tell you whether this medicine is suitable for you.
Danish: Deres læge vil fortælle Dem, om denne medicin er den rette behandling for Dem.
English: The clinical relevance of MRP2 inhibition is not yet known.
Danish: Den kliniske relevans af MRP2-hæmning er endnu ikke kendt.
English: Effect of fidaxomicin on other transporters
Danish: Fidaxomicins effekt på andre transportører
English: This metabolite also shows antimicrobial activity (see section 5.1).
Danish: Denne metabolit udviser også antimikrobiel aktivitet (se pkt.
English: Reproductive and fertility parameters showed no statistically significant differences in rats treated with fidaxomicin at doses up to 6.3 mg/kg/day (intravenous).
Danish: Reproduktions- og fertilitetsparametre viste ikke statistisk signifikante forskelle hos rotter behandlet med fidaxomicin i doser op til 6,3 mg/kg/dag (intravenøs).
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Danish: Farmakokinetisk/Farmakodynamisk forhold (PK/PD)
English: It is not known whether fidaxomicin passes into breast milk, but it is not expected to do so.
Danish: Man ved ikke, om fidaxomicin kan passere over i mælk, men det forventes ikke.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003 100 x 1 film-coated tablet EU/1/11/733/004 20 x 1 film-coated tablet 13.
Danish: EU/1/11/733/003 100 x 1 filmovertrukken tablet EU/1/11/733/004 20 x 1 filmovertrukken tablet
English: Date of latest renewal: 22 August 2016
Danish: Dato for første markedsføringstilladelse: 05 december 2011 Dato for seneste fornyelse: 22 august 2016
English: Fidaxomicin (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure.
Danish: Fidaxomicin (200 mg to gange daglig) havde en lille, men ikke klinisk relevant effekt på eksponeringen for digoxin.
English: Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, and reproductive toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og reproduktionstoksicitet.
English: In the two clinical trials of patients with CDI, 47.9% (479/999) of patients (per protocol population) were ≥65 years of age and 27.5% (275/999) of patients were treated with concomitant antibiotics during the study period.
Danish: Beskrivelse af patientpopulationen i kliniske forsøg I de to kliniske forsøg med patienter med CDI var 47,9 % (479/999) af patienterne (pr. protokol populationen) ≥ 65 år gamle, og 27,5 % (275/999) af patienterne blev behandlet samtidigt med antibiotika i forsøgsperioden.
English: No extensive analysis of metabolites in plasma has been performed, due to low levels of systemic absorption of fidaxomicin.
Danish: Der er ikke udført nogen omfattende analyse af metabolitter i plasma på grund af lavt niveau af systemisk absorption af fidaxomicin.
English: The main elimination pathways of systemically available fidaxomicin have not been characterized.
Danish: Hovedeliminationsvejen af systemisk tilgængeligt fidaxomicin er ikke karakteriseret.
English: Fidaxomicin is a topically acting drug that cannot be used to treat systemic infections; therefore the establishment of a clinical breakpoint is not relevant.
Danish: Fidaxomicin virker lokalt og kan ikke anvendes til behandling af systemiske infektioner, og derfor er etablering af et klinisk breakpoint ikke relevant.
English: Twenty-four percent of patients met at least one of the following three criteria at baseline for scoring severity: body temperature >38.5°C, leukocyte count >15,000, or creatinine value ≥1.5 mg/dl.
Danish: Fireogtyve procent af patienterne opfyldte mindst et af de følgende tre kriterier for scoren svær ved baseline: Legemstemperatur > 38,5° C, leukocyttælling > 15.000 eller kreatininværdi ≥ 1,5 mg/dl.
English: No adverse reactions for acute overdose have been reported during clinical studies or from post-marketing data.
Danish: Der er ikke rapporteret tilfælde af akut overdosering under kliniske studier eller efter markedsføring.
English: However, a larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilat cannot be excluded.
Danish: En større effekt på P-gp-substrater med lavere biotilgængelighed, som er mere følsomme over for intestinal P-gp-hæmning, såsom dabigatranetexilat, kan imidlertid ikke udelukkes.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: The volume of distribution in humans is unknown, due to very limited absorption of fidaxomicin.
Danish: Fordelingsvolumet i mennesker er ukendt på grund af meget begrænset absorption af fidaxomicin.
English: If you stop taking DIFICLIR
Danish: Hvis De holder op med at tage DIFICLIR
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: As a precautionary measure, it is preferable to avoid the use of DIFICLIR during pregnancy.
Danish: For en sikkerheds skyld bør DIFICLIR undgås under graviditeten.
English: Limited data suggest that gender, weight and race do not have any major influence on the plasma concentration of fidaxomicin or OP-1118.
Danish: Begrænsede data tyder på, at køn, vægt og race ikke har nogen større indflydelse på plasmakoncentrationen af fidaxomicin eller OP-1118.
English: There was very limited accumulation of fidaxomicin or OP-1118 in plasma following administration of 200 mg fidaxomicin every 12 hours for 10 days.
Danish: Der var begrænset akkumulation af fidaxomicin eller OP-1118 i plasma efter administration af 200 mg fidaxomicin hver 12. time i 10 dage.
English: Some patients with hypersensitivity reactions reported a history of allergy to macrolides.
Danish: Nogle patienter med overfølsomhedsreaktioner har rapporteret om tidligere allergi overfor makrolider.
English: It interferes with RNA polymerase at a distinct site from that of rifamycins.
Danish: Det intefererer med RNA polymerase på et andet site end rifamycins.
English: Specific mutations of RNA polymerase are associated with reduced susceptibility to fidaxomicin.
Danish: Specifikke mutationer i RNA-polymerase er forbundet med reduceret følsomhed for fidaxomicin.
English: INFORMATION IN BRAILLE dificlir
Danish: INFORMATION I BRAILLESKRIFT
English: If you forget to take DIFICLIR
Danish: Hvis De har glemt at tage DIFICLIR
English: The epidemiological cut-off value for fidaxomicin and C. difficile, distinguishing the wild-type population from isolates with acquired resistance traits, is ≥1.0 mg/L.
Danish: Den epidemiologiske cut-off-værdi for fidaxomicin og C. difficile, som adskiller vildtype-populationen fra isolater med erhvervet resistente træk, er ≥1,0 mg/L.
English: It is unknown whether fidaxomicin and its metabolites are excreted in human milk.
Danish: Det er uvist, om fidaxomicin/metabolitter udskilles i human mælk.
English: Studies have demonstrated that fidaxomicin treatment did not affect Bacteroides concentrations or other major components of the microbiota in the faeces of CDI patients.
Danish: Studier har demonstreret, at fidaxomicinbehandling ikke påvirker koncentrationen af Bacteroides eller andre betydelige mikroorganismer i fæces hos CDI patienter.
English: Fidaxomicin does not induce or inhibit CYP450 enzymes in vitro.
Danish: Fidaxomicin hverken inducerer eller hæmmer CYP450-enzymer in vitro.
English: Only very low levels of OP-1118 and no fidaxomicin was detectable in human urine.
Danish: Kun en ganske lav koncentration af OP-1118, og ingen fidaxomicin, blev detekteret i human urin.
English: Inhibition of the Clostridial RNA polymerase occurs at a concentration 20-fold lower than that for the E. coli enzyme (1 μM vs. 20 μM), partly explaining the significant specificity of fidaxomicin activity.
Danish: Hæmning af Clostridial RNA polymerase forekommer ved koncentrationer, der er 20 gange lavere end for E. coli enzym (1 µM vs. 20 µM), hvilket delvist kan forklare fidaxomicinaktivitetens væsentlige specificitet.
English: There are no known transferable elements that confer resistance to fidaxomicin.
Danish: Der er ingen kendte overførlige elementer, som kan føre til resistens over for fidaxomicin.
English: The frequency of adverse reactions is defined as follows: 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: <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden
English: The recommended dose is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days.
Danish: Den anbefalede dosis er én tablet (200 mg) to gange dagligt (én tablet hver 12. time) i 10 dage.
English: A main metabolite, OP-1118, is formed through hydrolysis of the isobutyryl ester.
Danish: Den primære metabolit, OP-1118, dannes via hydrolyse af isobutyryl ester.
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, antibiotics, ATC code: A07AA12
Danish: Farmakoterapeutisk klassifikation: Antibiotika mod diarré, tarminflammatorika, antibiotika ATC kode: A07AA12
English: DIFICLIR is an antibiotic which contains the active substance fidaxomicin.
Danish: DIFICLIR er et antibiotikum, som indeholder det aktive stof fidaxomicin.
English: Take the tablet as soon as you remember, unless it is time for the next dose.
Danish: Tag én tablet, så snart De husker det, medmindre det er tidspunktet for næste dosis.I så fald, skal den glemte tablet springes over.
English: Cmax for fidaxomicin and OP-1118 in plasma were 22% and 33% lower following a high fat meal vs fasting, but the extent of exposure (AUC0-t) was equivalent.
Danish: Cmax for fidaxomicin og OP-1118 i plasma var 22 % og 33 % lavere efter et fedtholdigt måltid vs. faste, mens omfanget af eksponering (AUC0-t) var tilsvarende.
English: In vitro metabolism studies showed that the formation of OP-1118 is not dependent on CYP450 enzymes.
Danish: In vitro metabolismestudier viste, at dannelsen af OP-1118 ikke afhænger af CYP450-enzymer.
English: Fidaxomicin is a locally acting drug.
Danish: Fidaxomicin er et lokalt virkende lægemiddel.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from DIFICLIR 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 skal ophøre eller behandling med DIFICLIR seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: This medicinal product does not require any special storage conditions.
Danish: Der er ingen særlige krav vedrørende opbevaring af lægemidlet.
English: Table 1 displays adverse reactions associated with twice daily administration of fidaxomicin in the treatment of C. difficile infection, reported in at least two patients, presented by system organ class.
Danish: Tabel 1 viser bivirkninger opstillet efter organklasse, som er forbundet med administration af fidaxomicin to gange daglig i behandlingen af C. difficile infektion, og som er rapporteret hos mindst to patienter.
English: Fidaxomicin had no effects on fertility when evaluated in rats (see section 5.3).
Danish: Fertilitet Fidaxomicin havde ingen effekt på fertilitet ved evaluering i rotter (se pkt.
English: In healthy adults, Cmax is approximately 9.88 ng/ml and AUC0-t is 69.5 ng•hr/ml following administration of 200 mg fidaxomicin, with a Tmax of 1.75 hours.
Danish: Hos raske voksne er den gennemsnitlige Cmax 9,88 ng/ml og AUC0-t er 69,5 ng-hr/ml efter administration af 200 mg fidaxomicin med en Tmax på 1,75 timer.
English: Following a single dose of 200 mg fidaxomicin, the majority of the administered dose (over 92%) was recovered in the stool as fidaxomicin or its metabolite OP-1118 (66%).
Danish: Efter en enkelt dosis på 200 mg fidaxomicin var størstedelen af dosis (>92 %) bevaret som fidaxomicin eller metabolitten, OP-1118 (66 %) i fæces.
English: Fidaxomicin has an MIC90 of 0.25 mg/L versus C. difficile, and its main metabolite, OP-1118, has an MIC90 of 8 mg/L.
Danish: Fidaxomicin har en MIC90 på 0,25 mg/L, hvorimod C.difficile og den primære metabolit, OP-1118 har en MIC90 på 8 mg/L.
English: DIFICLIR is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) (see section 5.1).
Danish: DIFICLIR er indiceret til voksne til behandling af Clostridium difficile infektioner (CDI), også kaldet C. difficile-associeret diarré (CDAD) (se pkt.
English: Also no crossresistance has been discovered with any other antibiotic class including β-lactams, macrolides, metronidazole, quinolones, rifampin, and vancomycin.
Danish: Dertil er der ikke fundet kryds-resistens med andre antibiotika inklusiv β-lactamer, makrolider, metronidazoler, quinoloner, rifampin og vancomycin.
English: If you have taken more tablets than you should have, talk to a doctor.
Danish: Hvis De har taget flere tabletter end De burde, så spørg Deres læge til råds.
English: Although no effects on the breastfed newborns/infants are anticipated since the systemic exposure to fidaxomicin is low, a risk to the newborns/infants cannot be excluded.
Danish: Der forventes ingen påvirkning af nyfødte/spædbørn ammet af mødre i behandling med fidaxomicin, da den systemiske eksponering er lav, men en risiko for nyfødte/spædbørn kan ikke udelukkes.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: Fidaxomicin and OP-1118 levels were approximately 2 times higher in patients ≥ 65 years compared to patients < 65 years.
Danish: Fidaxomicin og OP-1118 niveauer var gennemsnitligt 2 gange højere hos patienter ≥65 år sammenlignet med patienter <65 år.
English: Limited data suggest that there is no major difference in plasma concentration of fidaxomicin or OP-1118 between patients with reduced renal function (creatinine clearance < 50 ml/min) and patients with normal renal function (creatinine clearance ≥ 50 ml/min).
Danish: Begrænsede data tyder på, at der ikke er nogen større forskel i plasmakoncentrationen af fidaxomicin eller OP-1118 mellem patienter med nedsat nyrefunktion (kreatinin-clearance < 50 ml/min) og patienter med normal nyrefunktion (kreatinin-clearance ≥ 50 ml/min).