natgillin/translations-raw huggingface dataset:
Incidensen af resistens over for caspofungin ved forskellige kliniske isolater af Aspergillus er sjælden.
The incidence of resistance to caspofungin by various clinical isolates of Aspergillus is rare.
Andre lægemidler kan også påvirke måden, Caspofungin Accord virker på.
Also some other medicines can affect the way Caspofungin Accord works.
• Behandling af invasiv candidiasis hos voksne patienter eller børn.
• Treatment of invasive candidiasis in adult or paediatric patients.
Dog har børn sandsynligvis en anden bivirkningsprofil i forhold til voksne patienter.
However, paediatric patients probably have a different adverse event profile compared to adult patients.
• svampeinfektion i næse, bihuler eller lunger (kaldet "invasiv aspergillosis"), hvis andre behandlinger mod svamp ikke har virket eller har givet bivirkninger.
• fungal infections in your nose, nasal sinuses or lungs (called ‘invasive aspergillosis') if other anti-fungal treatments have not worked or have caused side effects.
• Ændringer i nogle blodprøver.
• Changes in some laboratory blood tests.
Denne infektion forårsages af en skimmelsvamp, som kaldes Aspergillus.
This infection is caused by a mould called Aspergillus.
Af de patienter der fik mere end 7 dages behandling med caspofungin, havde 50% (26/52) gunstigt respons.
For those patients who received more than 7 days of therapy with caspofungin, 50 % (26/52) had a favourable response.
Patienter med sjælden, arvelig fructoseintolerance eller sucrase-isomaltasemangel bør ikke anvende dette lægemiddel (se pkt.
Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicinal product (see section 2).
De patienter, der opfyldte inklusionskriterierne og fik en eller flere doser caspofungin, blev inkluderet i effektanalysen.
Patients who met the entry criteria and received one or more doses of caspofungin study therapy were included in the efficacy analysis.
Plasmakoncentrationen af caspofungin falder i et polyfasisk mønster efter enkelt 1-times intravenøs infusion.
Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour intravenous infusions.
Begrænsede data tyder på at mindre almindelige ikke-Candida gærsvampe og ikke-Aspergillus skimmelsvampe ikke dækkes af caspofungin.
Limited data suggest that less common non-Candida yeasts and non-Aspergillus moulds are not covered by caspofungin.
Caspofungin skal initieres af en læge, som har erfaring i at behandle invasive svampeinfektioner.
Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections.
Af disse patienter havde 37 invasiv candidiasis, 10 havde invasiv aspergillosis og 1 patient havde candidiasis i øsofagus.
Of these, 37 had invasive candidiasis, 10 had invasive aspergillosis, and 1 patient had esophageal candidiasis.
Varigheden af empirisk behandling skal baseres på patientens kliniske respons.
Duration of empirical therapy should be based on the patient's clinical response.
Alle de unge fik doser >50 mg dagligt, og faktisk fik 6 ud af 8 den maksimale dosis på 70 mg/dag.
All adolescents received doses >50 mg daily, and, in fact, 6 of 8 received the maximum dose of 70 mg/day.
Hos voksne patienter med moderat nedsat leverfunktion eller høj vægt kan en dosisjustering være nødvendig (se nedenfor).
In adult patients with moderate liver impairment or in higher weight patients, a dosage adjustment may be necessary (see below).
Disse øgninger i AUC hænger sandsynligvis sammen med reduceret hepatisk optagelse af caspofungin.
These AUC increases are probably due to reduced uptake of caspofungin by the liver.
Trin 1 Rekonstitution af almindelige hætteglas
Step 1 Reconstitution of conventional vials
Caspofungin bindes i udstrakt grad til albumin.
Caspofungin is extensively bound to albumin.
• Diarré, kvalme eller opkastning
• Diarrhoea, nausea or vomiting
Efter to ugers administration havde rifampicin begrænset effekt på AUC, mens det mindste målte niveau var 30% lavere end hos voksne patienter, som fik caspofungin alene.
After two weeks' administration rifampicin had limited effect on AUC, but trough levels were 30 % lower than in adult subjects who received caspofungin alone.
Caspofungin reducerede mindste målte koncentration af tacrolimus med 26% hos frivillige raske voksne.
Caspofungin reduced the trough concentration of tacrolimus by 26 % in healthy adult volunteers.
Rifampicin forårsagede en 60% øgning i AUC og 170% øgning i mindste målte koncentration af caspofungin på den første dag med co-administration når lægemidlerne blev initieret samtidigt hos raske voksne frivillige.
Rifampicin caused a 60 % increase in AUC and 170 % increase in trough concentration of caspofungin on the first day of co-administration when both medicinal products were initiated together in healthy adult volunteers.
Effekten af caspofungin over for disse svampepatogener er ikke fastlagt.
The efficacy of caspofungin against these fungal pathogens has not been established.
På Dag 1 var C1t den samme, og C24t var let forhøjet (36%) hos disse nyfødte og spædbørn i forhold til voksne.
On Day 1, C1 hr was comparable and C24 hr modestly elevated (36 %) in these neonates and infants relative to adults.
Den hyppigste diagnose var blodforgiftning (candidaæmi) (77%, n=186) og Candida-peritonitis (8%, n=19); patienter med Candida endocarditis, osteomyelitis eller meningitis blev holdt ude af denne undersøgelse.
The most frequent diagnoses were bloodstream infections (candidaemia) (77 %, n=186) and Candida peritonitis (8 %, n=19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
Volumen af rekonstitueret Caspofungin Accord til overførsel til intravenøs pose eller flaske
Volume of reconstituted Caspofungin Accord for transfer to intravenous bag or bottle
Indberettede kliniske og laboratoriemæssige abnormaliteter blandt alle voksne, der er behandlet med caspofungin (i alt 1.780), var sædvanligvis milde og krævede sjældent seponering.
Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.
Patienter, som får unormale leverfunktionsprøver under behandling med caspofungin, skal monitoreres for tegn på forværring af leverfunktionen, og risiko/fordel ved fortsat caspofungin-behandling skal revurderes.
Patients who develop abnormal liver function tests during caspofungin therapy should be monitored for evidence of worsening hepatic function and the risk/benefit of continuing caspofungin therapy should be re-evaluated.
Dosisjustering er ikke nødvendig på baggrund af køn og race (se pkt.
No dosage adjustment is necessary based on gender or race (see section 5.2).
• hoste, alvorlige vejrtrækningsproblemer - hvis De er voksen og har invasiv aspergillose, kan De få alvorlige vejrtrækningsproblemer, som kan medføre åndedrætssvigt.
• cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Storbritannien
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom
Dette gælder også medicin, som ikke er købt på recept, f.eks naturlægemidler.
This includes medicines obtained without a prescription, including herbal medicines.
To mellemprodukter, dannet under nedbrydningen af caspofungin ved ringåbning, danner kovalente adduktorer til plasmaproteiner, resulterende i irreversibel binding til plasmaproteiner i mindre grad.
Two intermediate products, formed during the degradation of caspofungin to this open ring compound, form covalent adducts to plasma proteins resulting in a low-level, irreversible binding to plasma proteins.
EUCAST har fastlagt standardiserede teknikker for følsomhedstest for gærsvampe.
Standardised techniques for susceptibility testing have been established for yeasts by EUCAST.
Tæt monitorering af leverenzymerne skal overvejes, hvis caspofungin og ciclosporin administreres samtidigt.
Close monitoring of liver enzymes should be considered if caspofungin and cyclosporin are used concomitantly.
In vitro undersøgelser viser, at caspofungin ikke hæmmer CYP- enzymer 1A2, 2A6, 2C9, 2C19, 2D6 eller 3A4.
In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
Hos børn (i alderen 12 måneder til 17 år) skal dosis baseres på patientens legemsoverfladeareal (se Instructions for Use in Paediatric Patients, Mosteller Formula).
In paediatric patients (12 months to 17 years of age), dosing should be based on the patient's body surface area (see Instructions for Use in Paediatric Patients, Mosteller1 Formula).
• Forhøjet blodtryk og ændringer i nogle blodprøver (herunder elektrolytter i nyrerne og koagulationstest), forhøjet koncentration af de lægemidler, De tager, som svækker immunsystemet
• Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system
• Behandling af invasiv aspergillose hos voksne patienter eller børn, der er refraktære eller intolerante over for amphotericin B, lipidformuleringer af amphotericin B og/eller itraconazol.
• Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole.
Kvinder, der får caspofungin, bør ikke amme.
Women receiving caspofungin should not breast-feed.
Caspofungin udskilles og biotransformeres i ringe grad inden for de første 30 timer efter administration.
There is little excretion or biotransformation of caspofungin during the first 30 hours after administration.
Der er rapporteret om overfølsomhedsreaktioner (anafylaksi og mulige histaminmedierede reaktioner) (se pkt.
Hypersensitivity reactions (anaphylaxis and possibly histamine-mediated adverse reactions) have been reported (see section 4.4).
Der findes ingen oplysninger om, at Caspofungin Accord påvirker evnen til at køre bil eller betjene maskiner.
There is no information to suggest that Caspofungin Accord affects your ability to drive or operate machinery.
Caspofungin er også blevet vurderet ved 150 mg dagligt (i op til 51 dage) hos 100 voksne patienter (se pkt.
Caspofungin has also been evaluated at 150 mg daily (for up to 51 days) in 100 adult patients (see section 5.1).
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.
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).
Det mindste målte niveau for caspofungin faldt gradvist efter gentagen administration.
Caspofungin trough levels gradually decreased upon repeated administration.
Raterne af gunstigt respons for patienter som enten var refraktære eller intolerante overfor tidligere behandlinger var hhv. 36% (19/53) og 70% (7/10).
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.
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.
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.
Disse tilfælde har ikke resulteret i klinisk vigtige bivirkninger.
These occurrences did not result in clinically important adverse reactions.
Reduktion af daglig dosis til 35 mg anbefales til voksne med moderat nedsat leverfunktion.
A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment.
De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at caspofungin udskilles i mælk.
Available pharmacodynamic/ toxicological data in animals have shown excretion of caspofungin in milk.
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.
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.
Dyreforsøg har påvist udviklingstoksicitet (se pkt.
Animal studies have shown developmental toxicity (see section 5.3).
Gunstige responsrater hos patienter med neutropeni var 7/14 (50%) i caspofungin-gruppen og 4/10 (40%) i amphotericin B-gruppen..
Favourable response rates in neutropaenic patients were 7/14 (50 %) in the caspofungin group and 4/10 (40 %) in the amphotericin B group.
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]).
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]).
Der er rapporteret følgende bivirkninger:
The following adverse reactions were reported:
Fortæl lægen, sundhedspersonalet eller apotekspersonalet, hvis De tager et eller flere af følgende lægemidler:
Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Caspofungin er et semisyntetisk lipopeptid (echinocandin), syntetiseret fra et fermenteringsprodukt af Glarea lozoyensis.
Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis.
Der er, hos patienter som behandledes empirisk eller som havde invasiv candidiasis, set en tilsvarende beskeden stigning hos ældre patienter sammenlignet med yngre.
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.
Caspofungins sikkerhed og effekt blev vurderet hos børn i alderen 3 måneder til 17 år i to prospektive, kliniske multicenterundersøgelser.
The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicentre clinical trials.
Caspofungin øgede ikke ciclosporins plasmaniveauer.
Caspofungin did not increase the plasma levels of cyclosporin.
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.
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.
50 mg ved reduceret volumen 10 ml
50 mg at reduced volume
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%).
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%).
Caspofungin udviser moderat non-lineær farmakokinetik med øget akkumulering ved stigende doser, og tiden indtil steady-state opnås, efter administration af gentagne doser.
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.
Hos patienter med invasiv aspergillose er der også rapporteret om lungeødemer, ARDS (Adult Respiratory Distress Syndrome) samt radiografiske infiltrationer.
Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
Caspofungin Accord kan også medføre alvorlige bivirkninger på huden såsom Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN).
Caspofungin Accord may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Der er set laboratoriemæssige abnormaliteter i leverfunktionsprøver hos raske frivillige samt voksne og pædiatriske patienter, der er blevet behandlet med caspofungin.
Laboratory abnormalities in liver function tests have been seen in healthy volunteers and adult and paediatric patients treated with caspofungin.
Tæt monitorering af leverenzymerne skal overvejes, hvis de to produkter administreres samtidigt.
Close monitoring of liver enzymes should be considered if the two medicinal products are used concomitantly.
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.
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.
Caspofungin er ikke dialyserbart, og yderligere dosering er derfor ikke nødvendig efter hæmodialyse.
Caspofungin is not dialysable, thus supplementary dosing is not required following haemodialysis.
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.
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.
Dette fund kan indikere, at børn vil få de samme fald med induktorer som voksne.
This finding may indicate that paediatric patients will have similar reductions with inducers as seen in adults.
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.
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.
Til voksne patienter med moderat nedsat leverfunktion (Child-Pugh score 7-9) anbefales caspofungin 35 mg dagligt på baggrund af farmakokinetiske data.
For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), Caspofungin 35 mg daily is recommended based upon pharmacokinetic data.
Der findes både 70 mg og 50 mg hætteglas.
Both 70 mg and 50 mg vials are available.
Behandlingens varighed for invasiv aspergillose fastsættes individuelt og bør baseres på sværhedsgraden af patientens primærsygdom, restitution efter immunosuppression og klinisk respons.
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.
En højere eksponering end for moderat nedsat leverfunktion forventes, og caspofungin skal anvendes med forsigtighed hos disse patienter (se pkt.
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).
Patienterne i undersøgelsen med empirisk behandling havde modtaget kemoterapi for malignitet eller havde fået hæmatopoietisk stamcelle transplantation (inklusive 39 allogene transplantationer).
In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation (including 39 allogeneic transplantations).
Kontakt lægen, sundhedspersonalet, eller apotekspersonalet, før De får Caspofungin Accord, hvis:
Talk to your doctor, nurse or pharmacist before you are given Caspofungin Accord if:
Hvis De har fået for meget Caspofungin Accord Lægen bestemmer, hvor meget Caspofungin Accord, De har brug for og hvor lang tid hver dag.
Your doctor will decide how much Caspofungin Accord you need and for how long each day.
Samtidig administration af caspofungin og ciclosporin er blevet evalueret hos raske voksne frivillige og hos patienter.
Concomitant use of caspofungin with cyclosporin has been evaluated in healthy adult volunteers and in adult patients.
Det tilhører en gruppe af svampedræbende lægemidler.
This belongs to a group of medicines called anti-fungals.
Det skal De vide, før De får Caspofungin Accord).
What you need to know before you are given Caspofungin Accord).
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).
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).
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).
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).
• Kuldegysninger, feber
• Chills, fever
Det er ikke nødvendigt at justere dosis til patienter med nedsat nyrefunktion.
No dosage adjustment is necessary for patients with renal impairment.
I begrænset klinisk erfaring er resistens over for caspofungin set hos patienter med invasiv aspergillose.
In limited clinical experience, resistance to caspofungin in patients with invasive aspergillosis has been observed.
Dette skyldes, at det ikke indeholder konserveringsmiddel.
This is because it does not contain any ingredients to stop the growth of bacteria.
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.
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.
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.
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.