FrancophonIA/ELRC3.0 huggingface dataset:
English: Caspofungin has also been evaluated at 150 mg daily (for up to 51 days) in 100 adult patients (see section 5.1).
Danish: Caspofungin er også blevet vurderet ved 150 mg dagligt (i op til 51 dage) hos 100 voksne patienter (se pkt.
English: The average exposure in an adult patient weighing 80 kg was predicted to be about 23 % lower than in an adult patient weighing 60 kg (see section 4.2).
Danish: Den gennemsnitlige eksponering for en voksen patient med en kropsvægt på 80 kg var forudsagt til at være ca. 23% lavere end for en voksen patient med en kropsvægt på 60 kg (se pkt.
English: Caspofungin trough levels gradually decreased upon repeated administration.
Danish: Det mindste målte niveau for caspofungin faldt gradvist efter gentagen administration.
English: The favourable response rates for patients who were either refractory to or intolerant of previous therapies were 36 % (19/53) and 70 % (7/10), respectively.
Danish: Raterne af gunstigt respons for patienter som enten var refraktære eller intolerante overfor tidligere behandlinger var hhv. 36% (19/53) og 70% (7/10).
English: Patients found to have a fungal infection should be treated for a minimum of 14 days and treatment should continue for at least 7 days after both neutropaenia and clinical symptoms are resolved.
Danish: Patienter med svampeinfektioner bør modtage behandling i mindst 14 dage og behandlingen bør fortsættes i mindst 7 dage efter resolution af såvel neutropeni som kliniske symptomer.
English: These occurrences did not result in clinically important adverse reactions.
Danish: Disse tilfælde har ikke resulteret i klinisk vigtige bivirkninger.
English: A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment.
Danish: Reduktion af daglig dosis til 35 mg anbefales til voksne med moderat nedsat leverfunktion.
English: Available pharmacodynamic/ toxicological data in animals have shown excretion of caspofungin in milk.
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at caspofungin udskilles i mælk.
English: Patients had to be either refractory to (disease progression or failure to improve with other antifungal therapies given for at least 7 days) (84 % of the enrolled patients) or intolerant of (16 % of enrolled patients) other standard antifungal therapies.
Danish: Patienterne skulle være enten refraktære (sygdomsprogression eller manglende bedring ved andre antimykotiske behandlinger givet i mindst 7 dage) (84% af de inkluderede patienter), eller intolerante (16% af de inkluderede patienter) over for andre antimykotiske standardbehandlinger.
English: Animal studies have shown developmental toxicity (see section 5.3).
Danish: Dyreforsøg har påvist udviklingstoksicitet (se pkt.
English: Favourable response rates in neutropaenic patients were 7/14 (50 %) in the caspofungin group and 4/10 (40 %) in the amphotericin B group.
Danish: Gunstige responsrater hos patienter med neutropeni var 7/14 (50%) i caspofungin-gruppen og 4/10 (40%) i amphotericin B-gruppen..
English: Most patients had underlying conditions (haematologic malignancy [N = 24], allogeneic bone marrow transplant or stem cell transplant [N = 18], organ transplant [N = 8], solid tumour [N = 3], or other conditions [N = 10]).
Danish: De fleste patienter havde primærsygdomme (malign hæmatologisk sygdom [N = 24], allogen knoglemarvstransplantation eller stamcelletransplantation [N = 18], organtransplantation [N = 8], solid tumor [N = 3], eller andre tilstande [N = 10]).
English: The following adverse reactions were reported:
Danish: Der er rapporteret følgende bivirkninger:
English: Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
Danish: Fortæl lægen, sundhedspersonalet eller apotekspersonalet, hvis De tager et eller flere af følgende lægemidler:
English: Detailed information on this product is available on the website of the European Medicines Agency 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: Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis.
Danish: Caspofungin er et semisyntetisk lipopeptid (echinocandin), syntetiseret fra et fermenteringsprodukt af Glarea lozoyensis.
English: In patients who were treated empirically or who had invasive candidiasis, a similar modest effect of age was seen in older patients relative to younger patients.
Danish: Der er, hos patienter som behandledes empirisk eller som havde invasiv candidiasis, set en tilsvarende beskeden stigning hos ældre patienter sammenlignet med yngre.
English: The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicentre clinical trials.
Danish: Caspofungins sikkerhed og effekt blev vurderet hos børn i alderen 3 måneder til 17 år i to prospektive, kliniske multicenterundersøgelser.
English: Caspofungin did not increase the plasma levels of cyclosporin.
Danish: Caspofungin øgede ikke ciclosporins plasmaniveauer.
English: The proportion of patients with a serious drug-related adverse reaction or a drug-related adverse reaction leading to caspofungin discontinuation was comparable in the 2 treatment groups.
Danish: Den del af patienterne, der fik en alvorlig lægemiddelrelateret bivirkning eller en lægemiddelrelateret bivirkning, som førte til seponering af caspofungin, var sammenlignelig i de to behandlingsgrupper.
English: 50 mg at reduced volume
Danish: 50 mg ved reduceret volumen 10 ml
English: The most common drug-related clinical adverse experiences reported in paediatric patients treated with caspofungin were pyrexia (11.7%), rash (4.7%) and headache (2.9%).
Danish: De mest almindelige lægemiddelrelaterede kliniske bivirkninger, der er rapporteret hos børn behandlet med caspofungin var pyreksi (11,7%), udslæt (4,7%) og hovedpine (2,9%).
English: Caspofungin displays moderate non-linear pharmacokinetics with increased accumulation as the dose is increased, and a dose dependency in the time to reach steady state upon multiple-dose administration.
Danish: Caspofungin udviser moderat non-lineær farmakokinetik med øget akkumulering ved stigende doser, og tiden indtil steady-state opnås, efter administration af gentagne doser.
English: Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
Danish: Hos patienter med invasiv aspergillose er der også rapporteret om lungeødemer, ARDS (Adult Respiratory Distress Syndrome) samt radiografiske infiltrationer.
English: Caspofungin Accord may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Danish: Caspofungin Accord kan også medføre alvorlige bivirkninger på huden såsom Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN).
English: Laboratory abnormalities in liver function tests have been seen in healthy volunteers and adult and paediatric patients treated with caspofungin.
Danish: Der er set laboratoriemæssige abnormaliteter i leverfunktionsprøver hos raske frivillige samt voksne og pædiatriske patienter, der er blevet behandlet med caspofungin.
English: Close monitoring of liver enzymes should be considered if the two medicinal products are used concomitantly.
Danish: Tæt monitorering af leverenzymerne skal overvejes, hvis de to produkter administreres samtidigt.
English: In some adult and paediatric patients with serious underlying conditions who were receiving multiple concomitant medications with caspofungin, cases of clinically significant hepatic dysfunction, hepatitis and hepatic failure have been reported; a causal relationship to caspofungin has not been established.
Danish: Hos nogle voksne og pædiatriske patienter med alvorlige primærsygdomme, som havde fået adskillige samtidige behandlingsregimer med caspofungin, er der rapporteret tilfælde af klinisk signifikant leverdysfunktion, hepatitis og leversvigt; årsagssammenhæng med caspofungin er ikke påvist.
English: Caspofungin is not dialysable, thus supplementary dosing is not required following haemodialysis.
Danish: Caspofungin er ikke dialyserbart, og yderligere dosering er derfor ikke nødvendig efter hæmodialyse.
English: Invasive Candidiasis in Adult Patients: Two hundred thirty-nine patients were enrolled in an initial study to compare caspofungin and amphotericin B for the treatment of invasive candidiasis.
Danish: Invasiv Candidiasis hos voksne patienter: Der blev inkluderet 239 patienter i en initial undersøgelse med henblik på at sammenligne caspofungin med amphotericin B til behandling af invasiv candidiasis.
English: This finding may indicate that paediatric patients will have similar reductions with inducers as seen in adults.
Danish: Dette fund kan indikere, at børn vil få de samme fald med induktorer som voksne.
English: Possibly histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm have been reported and may require discontinuation and/or administration of appropriate treatment.
Danish: Der er rapporteret om mulige histaminmedierede reaktioner, herunder udslæt, ansigtshævelse, angioødem, pruritus, varmefornemmelse eller bronkospasmer, som kan kræve seponering og/eller administration af passende behandling.
English: For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), Caspofungin 35 mg daily is recommended based upon pharmacokinetic data.
Danish: Til voksne patienter med moderat nedsat leverfunktion (Child-Pugh score 7-9) anbefales caspofungin 35 mg dagligt på baggrund af farmakokinetiske data.
English: Both 70 mg and 50 mg vials are available.
Danish: Der findes både 70 mg og 50 mg hætteglas.
English: Duration of treatment of invasive aspergillosis is determined on a case by case basis and should be based upon the severity of the patient's underlying disease, recovery from immunosuppression, and clinical response.
Danish: Behandlingens varighed for invasiv aspergillose fastsættes individuelt og bør baseres på sværhedsgraden af patientens primærsygdom, restitution efter immunosuppression og klinisk respons.
English: A higher exposure than in moderate hepatic impairment is expected and caspofungin should be used with caution in these patients (see sections 4.2 and 5.2).
Danish: En højere eksponering end for moderat nedsat leverfunktion forventes, og caspofungin skal anvendes med forsigtighed hos disse patienter (se pkt.
English: In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation (including 39 allogeneic transplantations).
Danish: Patienterne i undersøgelsen med empirisk behandling havde modtaget kemoterapi for malignitet eller havde fået hæmatopoietisk stamcelle transplantation (inklusive 39 allogene transplantationer).
English: Talk to your doctor, nurse or pharmacist before you are given Caspofungin Accord if:
Danish: Kontakt lægen, sundhedspersonalet, eller apotekspersonalet, før De får Caspofungin Accord, hvis:
English: Your doctor will decide how much Caspofungin Accord you need and for how long each day.
Danish: Hvis De har fået for meget Caspofungin Accord Lægen bestemmer, hvor meget Caspofungin Accord, De har brug for og hvor lang tid hver dag.
English: Concomitant use of caspofungin with cyclosporin has been evaluated in healthy adult volunteers and in adult patients.
Danish: Samtidig administration af caspofungin og ciclosporin er blevet evalueret hos raske voksne frivillige og hos patienter.
English: This belongs to a group of medicines called anti-fungals.
Danish: Det tilhører en gruppe af svampedræbende lægemidler.
English: What you need to know before you are given Caspofungin Accord).
Danish: Det skal De vide, før De får Caspofungin Accord).
English: Response rates to caspofungin and liposomal amphotericin B for baseline infections caused by Aspergillus species were, respectively, 41.7 % (5/12) and 8.3 % (1/12), and by Candida species were 66.7 % (8/12) and 41.7 % (5/12).
Danish: Responsraterne for caspofungin og liposomal amphotericin B for baseline infektioner grundet Aspergillus arter var henholdsvis 41,7% (5/12) og 8,3% (1/12), og Candida arter 66,7% (8/12) og 41,7% (5/12).
English: Although the doses of prior antifungal therapies in 5 patients enrolled as refractory were lower than those often administered for invasive aspergillosis, the favourable response rate during therapy with caspofungin was similar in these patients to that seen in the remaining refractory patients (2/5 versus 17/48, respectively).
Danish: Selvom doserne af tidligere anvendt antimykotisk behandling for 5 af patienterne, der var inkluderet som refraktære, var lavere end de doser der ofte gives for invasiv aspergillose, var raterne af gunstigt respons under caspofunginbehandling for disse patienter magen til dem set for resten af de refraktære patienter (henholdsvis 2/5 og 17/48).
English: • Chills, fever
Danish: • Kuldegysninger, feber
English: No dosage adjustment is necessary for patients with renal impairment.
Danish: Det er ikke nødvendigt at justere dosis til patienter med nedsat nyrefunktion.
English: In limited clinical experience, resistance to caspofungin in patients with invasive aspergillosis has been observed.
Danish: I begrænset klinisk erfaring er resistens over for caspofungin set hos patienter med invasiv aspergillose.
English: This is because it does not contain any ingredients to stop the growth of bacteria.
Danish: Dette skyldes, at det ikke indeholder konserveringsmiddel.
English: In the studies involving patients with documented Candida infections, the majority of the patients with invasive Candida infections had serious underlying medical conditions (e.g., haematologic or other malignancy, recent major surgery, HIV) requiring multiple concomitant medications.
Danish: I undersøgelserne med patienter med dokumenterede Candida infektioner havde de fleste patienter med invasive Candida-infektioner alvorlige primærsygdomme (for eksempel hæmatologisk eller anden malignitet, nyligt større kirurgisk indgreb, HIV), med behov for adskillige samtidige behandlingsregimer.
English: In this group of patients, the safety of caspofungin at this higher dose appeared generally similar to patients receiving the 50-mg daily dose of caspofungin.
Danish: I denne patientgruppe var sikkerheden for caspofungin ved den høje dosis generelt den samme som hos de patienter, der fik caspofungin i en daglig dosis på 50 mg.
English: • cyclosporin or tacrolimus (used to help prevent organ transplant rejection or to suppress your immune system) as your doctor may need to run extra blood tests during your treatment
Danish: • ciclosporin eller tacrolimus (medvirker til at forhindre afstødning af et transplanteret organ eller til at undertrykke immunforsvaret), da det kan være nødvendigt, at lægen tager ekstra blodprøver under behandlingen
English: Elderly: A modest increase in AUC (28 %) and C24h (32 %) was observed in elderly male subjects compared with young male subjects.
Danish: Ældre patienter: Der sås beskeden stigning i AUC (28%) og C24 t (32%) hos ældre, mandlige patienter sammenlignet med unge, mandlige patienter.
English: Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], and Aspergillus candidus [N = 3]).
Danish: Caspofungin virker in vitro mod Aspergillusarter (Aspergillus fumigatus N = 75, Aspergillus flavus N = 111, Aspergillus niger N = 31, Aspergillus nidulans N = 8, Aspergillus terreus N = 52 og Aspergillus candidus [N = 3]).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after reconstitution and dilution.
Danish: 1 hætteglas ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse efter rekonstitution og fortynding.
English: Invasive Aspergillosis in Adult Patients: Sixty-nine adult patients (age 18-80) with invasive aspergillosis were enrolled in an open-label, non-comparative study to evaluate the safety, tolerability, and efficacy of caspofungin.
Danish: Invasiv Aspergillose hos voksne patienter: 69 voksne patienter (i alderen 18-80) med invasiv aspergillose blev inkluderet i en åben, non-komparativ undersøgelse, med henblik på at vurdere sikkerhed, tolerabilitet samt effekt af caspofungin.
English: If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Danish: Hvis De har yderligere spørgsmål om brugen af denne medicin, skal De spørge lægen, sundhedspersonalet eller apotekspersonalet.
English: Caspofungin acetate inhibits the synthesis of beta (1,3)-D-glucan, an essential component of the cell wall of many filamentous fungi and yeast.
Danish: Caspofunginacetat hæmmer syntesen af beta (1,3)-D-glucan, en vigtig bestanddel af cellevæggen i mange trådsvampe og i gær.
English: However, in adult patients with invasive candidiasis, oesophageal candidiasis, or invasive aspergillosis who received multiple daily doses of caspofungin 50 mg, there was no significant effect of mild to advanced renal impairment on caspofungin concentrations.
Danish: Hos voksne patienter med invasiv candidiasis, esophageal candidiasis eller invasiv aspergillose, som fik gentagne, daglige doser caspofungin 50 mg, havde let til fremskreden nedsat nyrefunktion dog ingen betydelig effekt på koncentrationen af caspofungin.
English: In lieu of breakpoints, Candida isolates that are susceptible to anidulafungin as well as micafungin should be considered susceptible to caspofungin.
Danish: I stedet for grænseværdier skal Candida-isolater, som er følsomme for anidulafungin så vel som for micafungin, anses for at være følsomme for caspofungin.
English: • suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic.
Danish: • formodet svampeinfektion med feber og nedsat antal hvide blodlegemer, som ikke reagerer på behandling med antibiotika.
English: Similarly, C. parapsilosis isolates intermediate to anidulafungin and micafungin can be regarded intermediate to caspofungin.
Danish: Ligeledes kan C. parapsilosis-isolater, som er intermediært følsomme for anidulafungin og micafungin, anses for at være intermediært følsomme for caspofungin.
English: • you are already taking cyclosporin (used to help prevent organ transplant rejection or to suppress your immune system) - as your doctor may need to run extra blood tests during your treatment.
Danish: • De er i behandling med ciclosporin (anvendes til at forhindre afstødning af et transplanteret organ eller til at undertrykke immunforsvaret) - da det kan være nødvendigt, at lægen tager ekstra blodprøver under behandlingen
English: Phlebitis was a commonly reported local injection-site adverse reaction in all patient populations.
Danish: Phlebitis var, hos alle patientpopulationer, en hyppigt rapporteret bivirkning fra infusionsstedet.
English: • Loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level in the blood, low calcium level in the blood, increase calcium level in the blood, low magnesium level in the blood, increase in acid level in the blood
Danish: • Appetitløshed, stigning i mængden af kropsvæske, forstyrrelser i kroppens saltbalance, højt indhold af sukker i blodet, lavt indhold af calcium i blodet, forhøjet calcium i blodet, lavt indhold af magnesium i blodet, stigning i syreindholdet i blodet
English: Other local reactions included erythema, pain/tenderness, itching, discharge, and a burning sensation.
Danish: Andre lokale reaktioner inkluderede erythem, smerter/ømhed, kløe, væsken samt brændende fornemmelse.
English: Development of in vitro resistance to caspofungin by Aspergillus species has been identified.
Danish: Udvikling af in vitro resistens over for caspofungin af Aspergillusarter er identificeret.
English: Studies in vitro show that caspofungin is not an inhibitor of any enzyme in the cytochrome P450 (CYP) system.
Danish: In-vitro undersøgelser viser, at caspofungin ikke hæmmer noget enzym i cytokrom P450 (CYP) systemet.
English: Mix gently until a clear solution is obtained.
Danish: Bland forsigtigt, indtil der fremkommer en klar opløsning.
English: Studies in vitro and in vivo demonstrate that exposure of Aspergillus to caspofungin results in lysis and death of hyphal apical tips and branch points where cell growth and division occur.
Danish: In vitro og in vivo undersøgelser viser, at når Aspergillus udsættes for caspofungin, resulterer det i lysering og død af svampetrådenes apikale spidser og punkter ved cellevækst og celledeling.
English: If the drug was well tolerated but the patient's fever persisted and clinical condition deteriorated after 5 days of therapy, the dosage of study drug could be increased to 70 mg/day of caspofungin (13.3 % of patients treated) or to 5.0 mg/kg/day of liposomal amphotericin B (14.3 % of patients treated).
Danish: Hvis lægemidlet var veltolereret, men feberen var vedholdende og den kliniske tilstand forværredes efter 5 dages behandling, kunne doseringen af studiemedicinen øges til 70 mg/dag caspofungin (13,3% af de behandlede patienter) eller til 5,0 mg/kg/dag liposomal amphotericin B (14,3% af de behandlede patienter).
English: The second study was a prospective, open-label, non-comparative study estimating the safety and efficacy of caspofungin in paediatric patients (ages 6 months to 17 years) with invasive candidiasis, esophageal candidiasis, and invasive aspergillosis (as salvage therapy).
Danish: Den anden undersøgelse var en prospektiv, åben, ikke-komparativ undersøgelse til vurdering af caspofungins sikkerhed og effekt hos børn (i alderen 6 måneder til 17 år) med invasiv candidiasis, candidiasis i øsofagus og invasiv aspergillosis (som livsreddende behandling).
English: Patients in the non-comparative Aspergillus study often had serious predisposing medical conditions (e.g., bone marrow or peripheral stem cell transplants, haematologic malignancy, solid tumours or organ transplants) requiring multiple concomitant medications.
Danish: Patienterne i den non-komparative Aspergillus-undersøgelse havde ofte alvorlige prædisponerende tilstande (for eksempel knoglemarvs- eller stamcelletransplantation, malign hæmatologisk sygdom, solide tumorer eller organtransplantation), med behov for adskillige samtidige behandlingsregimer.
English: • difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine.
Danish: • vejrtrækningsbesvær med hiven efter vejret eller forværring af udslæt - De kan have fået en allergisk reaktion på medicinen.
English: The response rates among patients with pulmonary disease and extrapulmonary disease were 47 % (21/45) and 28 % (5/18), respectively.
Danish: Responsraterne hos patienter med lungesygdom eller ekstrapulmonal sygdom var hhv. 47% (21/45) og 28% (5/18).
English: Developmental toxicity studies in rats showed that caspofungin caused decreases in foetal body weights and an increase in the incidence of incomplete ossification of vertebra, sternebra, and skull bone at doses of 5 mg/kg that were coupled to adverse maternal effects such as signs of histamine release in pregnant rats.
Danish: Udviklingstoksicitetsundersøgelser med rotter viste, at caspofungin forårsagede nedsat føtalvægt samt øgning i forekomsten af ufuldstændig ossifikation af vertebra, sternebra og kranie ved doser på 5 mg/kg, hvilket blev forbundet med maternelle bivirkninger så som tegn på histaminfrigørelse hos gravide rotter.
English: • Women given Caspofungin Accord should not breast-feed.
Danish: • Kvinder, der får Caspofungin Accord, må ikke amme.
English: The caspofungin plasma concentrations in these adolescents were reduced relative to adults receiving 70 mg daily, the dose most often administered to adolescents.
Danish: Caspofungins plasmakoncentration hos disse unge faldt relativt i forhold til de voksne, der fik 70 mg dagligt, som var den dosis, der oftest blev givet til unge.
English: • Flushing, low blood pressure
Danish: • Ansigts rødme, lavt blodtryk