FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Kanjinti has been shown overall to have a comparable quality, safety and effectiveness to Herceptin.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Kanjintis og Herceptins kvalitet, sikkerhed og virkning svarer til hinanden.
English: Therefore, the Agency's view was that, as for Herceptin, the benefit of Kanjinti outweighs the identified risk and it can be authorised.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Kanjinti opvejer de identificerede risici, som for Herceptin, og kan godkendes.
English: Kanjinti can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Danish: Kanjinti kan forårsage kardiotoksicitet (hjerteskade), herunder hjertesvigt (nedsat hjertefunktion).
English: How is Kanjinti used?
Danish: Hvordan anvendes Kanjinti?
English: What benefits of Kanjinti have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Kanjinti?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kanjinti have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Kanjinti.
English: How does Kanjinti work?
Danish: Hvordan virker Kanjinti?
English: These results are relevant to other populations and routes of administration.
Danish: Disse resultater er relevante for andre populationer og administrationsveje.
English: Frequency not known (cannot be estimated from available data)
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Total parenteral nutrition:
Danish: Total parenteral ernæring:
English: Compatibility with other concentrations is unknown.
Danish: Forligelighed med andre koncentrationer er ikke kendt.
English: • Problems with balance or coordination
Danish: • Balance- eller koordinationsproblemer
English: These precautions are also applicable to children.
Danish: Disse forsigtighedsregler gælder også for børn.
English: 1316 BN Almere The Netherlands
Danish: 1316 BN Almere Holland
English: • You have had an allergic reaction to other azoles.
Danish: • De har haft en allergisk reaktion over for andre azoler.
English: Plasma protein binding is estimated to be 58 %.
Danish: Plasmaproteinbindingen anslås til 58 %.
English: From all patients 58% were subject to myeloablative conditions regimens.
Danish: 58% af alle patienter blev underlagt myeloablative konditioneringsregimer.
English: Clinical Experience Successful outcome in this section is defined as complete or partial response.
Danish: Klinisk erfaring Positivt resultat defineres i dette afsnit som fuldstændigt eller delvis respons.
English: Prophylaxis should be initiated on the day of transplant and may be administered for up to 100 days.
Danish: Profylakse bør påbegyndes på transplantationsdagen og kan administreres i op til 100 dage.
English: Difference in proportions and the 95% confidence interval (CI)
Danish: Forskel i andele og 95% konfidensinterval (CI)
English: You may be switched from the intravenous infusion to tablets once your condition improves.
Danish: De kan blive skiftet fra intravenøs infusion til tabletter, så snart Deres tilstand forbedres.
English: Treatment duration should be as short as possible depending on the patient's clinical and mycological response.
Danish: Behandlingen bør være så kortvarig som muligt afhængigt af patientens kliniske og mykologiske respons.
English: Other significant side effects whose frequency is not known, but should be reported to your doctor immediately:
Danish: Andre betydelige bivirkninger, hvis hyppighed ikke er kendt, men som De øjeblikkeligt skal fortælle til lægen:
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: In this analysis a successful response was seen in 41 % of patients in both treatment arms.
Danish: I denne analyse var der succesfuld respons hos 41 % af patienterne i begge behandlingsarme.
English: The asterisk (*) indicates a two-way interaction.
Danish: En asterix (*) indikerer en to-vejs-interaktion.
English: It works by killing or stopping the growth of the fungi that cause infections.
Danish: Det virker ved at dræbe eller stoppe væksten af de svampe, som forårsager infektioner.
English: Not studied clinically.
Danish: Ikke undersøgt klinisk.
English: pH of the reconstituted solution is 4.0 to 7.0.
Danish: Den rekonstituerede opløsnings pH-værdi er 4,0 til 7,0.
English: It is used for the treatment of patients (adults and children over the age of 2) with:
Danish: Det bruges til behandling af patienter (voksne og børn over 2 år) med:
English: This should include laboratory evaluation, particularly serum creatinine.
Danish: Dette bør omfatte laboratorievurderinger, især serumkreatinin.
English: Osmolality: 500± 50 mOsm/kg
Danish: Osmolalitet: 500 ± 50 mOsm/kg
English: For example, 15-20 % of Asian populations may be expected to be poor metabolisers.
Danish: For eksempel forventes det, at det hos 15-20 % af de asiatiske populationer metaboliseres dårligt.
English: Oral Contraceptives*
Danish: Oral antikonception*
English: This enzyme exhibits genetic polymorphism.
Danish: Dette enzym viser genetisk polymorfi.
English: The median treatment duration was 15 days in both treatment arms.
Danish: Den gennemsnitlige behandlingsvarighed var 15 dage i begge behandlingsarme.
English: However, this reduced response was not correlated with elevated MICs.
Danish: Dette reducerede respons var dog ikke korreleret til højere MIC-værdier.
English: The majority (> 94 %) of the total radioactivity is excreted in the first 96 hours after both oral and intravenous dosing.
Danish: Størstedelen (>94 %) af den totale radioaktivitet bliver udskilt i de første 96 timer efter både oral og intravenøs dosering.
English: Patients with renal failure were excluded from this study.
Danish: Patienter med nyresvigt blev udelukket fra studiet.
English: No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
Danish: Der sås ikke klinisk signifikante forskelle, når sikkerhedsdata blev analyseret i relation til alder, race eller køn.
English: • A disorder in which the body's immune system attacks part of the peripheral nervous system
Danish: • Lidelse, hvor kroppens immunsystem angriber dele af det perifere nervesystem
English: In addition, a successful response was seen in 1 of 3 patients with infections caused by more than one organism including Scedosporium spp.
Danish: Derudover sås et succesrigt respons hos 1 ud af 3 patienter med infektioner forårsaget af mere end en organisme, herunder Scedosporium spp.
English: The following instructions apply to both Treatment and Prophylaxis.
Danish: Følgende instruktioner angår både behandling og profylakse.
English: Patients less than 40 kg**
Danish: Patienter under 40 kg**
English: Myeloablative conditioning regimens
Danish: Myeloablative konditioneringsregimer
English: Four additional patients with fusariosis had an infection caused by several organisms; two of them had a successful outcome.
Danish: Yderligere 4 patienter havde en fusarium-infektion forårsaget af adskillige organismer; 2 af dem havde et succesrigt resultat.
English: 7 Prolonged optic neuritis has been reported post-marketing.
Danish: 7 Længerevarende optisk neuritis er rapporteret efter markedsføringen.
English: In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp.
Danish: In vitro-aktivitet over for følgende patogener er vist, men den kliniske betydning er ukendt: Curvularia spp.
English: Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
Danish: Patienter med et nedsat immunsystem eller med svære infektioner kan have behov for langvarig behandling for at undgå, at infektionen kommer igen.
English: Patients must avoid potentially hazardous tasks, such as driving or operating machinery while experiencing these symptoms.
Danish: Patienter skal undgå mulige farlige handlinger, såsom at føre bil eller betjene maskiner, mens de har disse symptomer.
English: • You are suffering from, or have ever suffered from liver disease.
Danish: • De lider af eller har lidt af en leversygdom.
English: Clinical studies examining QTc interval
Danish: Kliniske studier, der undersøger QTc-intervallet
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er nævnt i pkt.
English: Your doctor may change your dose depending upon your condition.
Danish: Deres læge kan ændre Deres dosis afhængig af Deres tilstand.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The mechanism of action is unknown, although the site of action is most likely to be within the retina.
Danish: Virkningsmekanismen er ukendt, skønt reaktionen med stor sandsynlighed sker i retina.
English: Careful monitoring of blood glucose is recommended.
Danish: Omhyggelig monitorering af blodglucose anbefales.
English: Therefore, every attempt should be made to identify Candida to species level.
Danish: Alle forsøg på at bestemme Candida til artsniveau skal derfor gøres.
English: The clinical efficacy data were supported by limited susceptibility data.
Danish: Data vedrørende klinisk virkning bliver understøttet af begrænsede data for følsomhed.
English: The ERG measures electrical currents in the retina.
Danish: ERG måler elektriske strømninger i retina.
English: Greater than proportional increase in exposure is observed with increasing dose.
Danish: En forholdsmæssig større stigning i eksponering er set med stigende dosis.
English: Medicinal product [Mechanism of Interaction]
Danish: Lægemiddel [interaktionsmekanisme]
English: The absolute bioavailability of voriconazole after oral administration is estimated to be 96 %.
Danish: Den absolutte biotilgængelighed af voriconazol efter oral administration er anslået til 96 %.
English: It may cause transient and reversible changes to vision, including blurring, altered/enhanced visual perception and/or photophobia.
Danish: Det kan forårsage forbigående og reversible ændringer af synet, herunder sløret, ændret/forøget visuel perception og/eller fotofobi.
English: Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
Danish: Profylakse bør være så kortvarig som muligt afhængigt af risikoen for udvikling af invasiv svampeinfektion (IFI) som defineret ved neutropeni eller immunsuppression.
English: (Please refer to the end of this leaflet for further information).
Danish: (Se bagest i indlægssedlen for yderligere oplysninger).
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Danish: Denne indlægsseddel fås på alle sprog i EU/EEA på languages på Det Europæiske Lægemiddelagenturs hjemmeside.
English: Carcinogenicity studies were not performed with SBECD.
Danish: Karcinogenicitetsstudier er ikke udført med SBECD.
English: Successful response was seen in 24 patients (15 complete, 9 partial responses).
Danish: Succesrigt respons blev set hos 24 patienter (15 med fuldstændigt, 9 med delvist respons).
English: Patients should be monitored for the development of abnormal renal function.
Danish: Patienter bør monitoreres med henblik på udvikling af abnorm nyrefunktion.
English: Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
Danish: Af disse 7 patienter havde 3 patienter øjeninfektion, 1 havde sinusinfektion og 3 havde dissemineret infektion.
English: Frequency categories are expressed 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: Bivirkningsfrekvenser er angivet som: meget almindelig ≥1/10, almindelig ≥1/100 og <1/10, ikke almindelig ≥1/1000 og <1/100, sjælden (≥1/10000 og <1/1000); meget sjælden <1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {27 May 2015}
Danish: Dato for første markedsføringstilladelse: { 27 maj 2015}
English: However, as there were only 9 cases available for EUCAST analysis, there is currently insufficient evidence to set clinical breakpoints for C. krusei.
Danish: Da der kun var 9 tilfælde, der kunne anvendes til EUCAST-analyse, er der imidlertid på nuværende tidspunkt utilstrækkelig evidens til at kunne fastlægge kliniske grænseværdier for C. krusei.
English: The median duration of study drug prophylaxis was 95.5 days in the MITT group.
Danish: Medianvarigheden af profylaksen med studielægemidlet var 95,5 dage i MITT-gruppen.
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate sent to a reference laboratory.
Danish: Identifikationstests og antimikrobiel følsomhedstests på disse isolater skal gentages, og såfremt resultatet bekræftes, skal isolatet sendes til et referencelaboratorium.
English: 1 Includes febrile neutropenia and neutropenia.
Danish: 1 Inkluderer febril neutropeni og neutropeni.
English: Dosage adjustment (Adults)
Danish: Dosisjustering (voksne)
English: Once reconstituted further dilution is required before administration.
Danish: Efter rekonstituering skal den fortyndes yderligere før administration.
English: The recommended dose for adults (including elderly patients) is as follows:
Danish: Den anbefalede dosis til voksne (også ældre patienter) er:
English: - Reminds patients when and how to report relevant signs and symptoms of phototoxicity and skin cancer.
Danish: - Påminde patienter om, hvornår og hvordan de skal indberette relevante tegn og symptomer på fototoksicitet og hudcancer.
English: Reconstitute and dilute before use.
Danish: Rekonstitueres og fortyndes før brug.
English: Compatible Infusion Solutions: The reconstituted solution can be diluted with:
Danish: Kompatible infusionsopløsninger: Den rekonstituerede opløsning kan fortyndes med:
English: Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Danish: Forbigående hepatiske reaktioner, herunder hepatitis og gulsot, er set blandt patienter uden andre identificerbare risikofaktorer.
English: This impurity should be considered a substance with carcinogenic potential in humans.
Danish: Denne urenhed bør anses for at være en substans med karcinogene egenskaber hos mennesker.
English: In rats, mice and dogs, voriconazole also induced minimal adrenal changes.
Danish: Hos rotter, mus og hunde inducerede voriconazol også minimale adrenale forandringer.
English: For Caucasians and Blacks the prevalence of poor metabolisers is 3-5 %.
Danish: Blandt kaukasiere og personer af negroid afstamning er prævalensen af personer med dårlig metaboliseringsevne 3-5 %.
English: Tell your docotor if you experience this.
Danish: Kontakt Deres læge, hvis De oplever dette
English: Symptoms appeared immediately upon initiating the infusion (see section
Danish: Symptomerne opstod umiddelbart efter påbegyndt infusion (se også pkt.
English: Patients 40 kg and above**
Danish: Patienter 40 kg og derover**
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendix V.
English: • Treatment of serious fungal infections caused by Scedosporium spp.
Danish: • Behandling af alvorlige svampeinfektioner forårsaget af Scedosporium spp.
English: • Skin cancer
Danish: • Hudkræft
English: It is recommended to initiate the therapy with intravenous regimen, and oral regimen should be considered only after there is a significant clinical improvement.
Danish: Det anbefales, at behandling initieres med intravenøs behandling, og at oral behandling først overvejes efter signifikant klinisk bedring.
English: Interaction Geometric mean changes (%)
Danish: Geometrisk gennemsnitlig ændring (%)
English: These visual impairmentswere transient and fully reversible, with the majority spontaneously resolving within 60 minutes and no clinically significant long-term visual effects were observed.
Danish: Disse former for synsnedsættelse er forbigående og fuldt reversible og er for størstedelen spontant gået over inden for 60 minutter, og der ses ingen klinisk betydende visuelle langtidsvirkninger.
English: • Cardiomyopathy, in particular when heart failure is present
Danish: • Kardiomyopati, især hvis hjerteinsufficiens er til stede.
English: The safety profile and plasma concentrations observed in male and female patients were similar.
Danish: Sikkerhedsprofilen og plasmakoncentrationerne, der blev observeret, var ens for såvel de mandlige som kvindelige patienter.
English: - Provides HCPs with the current recommendations to monitor and manage these risks.
Danish: - Give aktuelle anbefalinger til læger og sundhedspersonale om overvågning og håndtering af disse risici.
English: The modified intent-to-treat (MITT) group included 465 allogeneic HSCT recipients with 45% of patients having AML.
Danish: Den modificerede intent- totreat-gruppe (MITT-gruppe) omfattede 465 patienter, der havde fået allogen HSCT, hvoraf 45% havde AML.
English: Hepatic function should be monitored in both children and adults.
Danish: Leverfunktionen bør monitoreres hos både børn og voksne.
English: Side effects with frequency not known: • Freckles and pigmented spots
Danish: Bivirkninger med ikke kendt hyppighed: • Fregner og pigmentpletter.
English: Serious refractory Candida infections
Danish: Alvorlige refraktære Candida-infektioner
English: Interactions between voriconazole and other medicinal products are listed in the table below (once daily as “QD”, twice daily as “BID”, three times daily as “TID” and not determined as “ND”).
Danish: Interaktionerne mellem voriconazol og andre lægemidler er anført i følgende skema (1 gang daglig som ”QD”, 2 gange daglig som ”BID”, 3 gange daglig som ”TID” og ikke fastlagt som ”ND”).
English: The ERG changes did not progress over 29 days of treatment and were fully reversible on withdrawal of voriconazole.
Danish: ERG-ændringerne progredierede ikke over 29 dages behandling og var fuldt reversible ved seponering af voriconazol.
English: The reconstituted solution can be diluted with:
Danish: Den rekonstituerede opløsning kan fortyndes med:
English: Prophylaxis in Adults and Children
Danish: Profylakse hos voksne og børn
English: Currently there are insufficient data to allow dosing recommendations in this situation (see section 4.5).
Danish: Der foreligger ikke tilstrækkelige data til at give doseringsanbefalinger i denne situation (se punkt 4.5).
English: • Existing symptomatic arrhythmias
Danish: • Eksisterende symptomatiske arytmier.
English: 2 Includes immune thrombocytopenic purpura.
Danish: 2 Inkluderer immun trombocytopenisk purpura.
English: Detailed information on dosage recommendations is provided in the following table:
Danish: Detaljeret information om dosisanbefalinger ses i følgende skema:
English: In clinical trials there were 3 cases of accidental overdose.
Danish: I kliniske studier var der 3 tilfælde af uforsætlig overdosering.
English: Pharmacokinetics in special patient groups
Danish: Farmakokinetik i specielle patientgrupper
English: From a microbiological point of view, once reconstituted, the product must be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal præparatet derfor bruges med det samme efter rekonstituering.
English: Blood products and short-term infusion of concentrated solutions of electrolytes:
Danish: Blodprodukter og korttidsinfusioner af elektrolytter:
English: Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended, and the dose of anticoagulants should be adjusted accordingly.
Danish: Tæt monitorering af protrombintid eller andre passende antikoagulationstest anbefales, og dosis af antikoagulantia bør tilsvarende justeres.
English: • Bleeding in the eye
Danish: • Blødning i øjet
English: Insufficient evidence
Danish: Utilstrækkelig evidens
English: In the light of these data the duration of treatment of the intravenous formulation should be no longer than 6 months.
Danish: I lyset af disse data bør behandlingsvarigheden af den intravenøse lægemiddelform ikke overstige 6 måneder.
English: Patients who did not have an assessment 12 weeks after EOT were counted as failures.
Danish: Patienter, som ikke blev vurderet 12 uger efter endt behandling (EOT), blev talt som behandlingssvigt.
English: Elevated liver enzymes were also observed more frequently in children.
Danish: Forhøjede leverenzymer er også observeret oftere hos børn.
English: Women of child-bearing potential must always use effective contraception during treatment.
Danish: Kvinder i den fertile alder bør altid anvende effektiv antikonception under behandlingen.
English: It may only be continued up to 180 days after transplantation in case of continuing immunosuppression or graft versus host disease (GvHD) (see section
Danish: Behandling må kun fortsættes i op til 180 dage efter transplantationen i tilfælde af vedvarende immunsuppression eller graft-versus-host sygdom (GvHD) (se pkt.
English: Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180 days after HSCT.
Danish: Succeskriteriet blev defineret som evnen til at fortsætte profylakse med studielægemidlet i 100 dage efter HSCT (uden at stoppe i >14 dage) og til at overleve uden påvist eller sandsynlig invasiv svampeinfektion i 180 dage efter HSCT.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning for at beskytte mod lys.
English: ≤S (Susceptible)
Danish: ≤ S (følsom)
English: 1 Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
Danish: 1 Stammer med MIC-værdier højere end følsomheds-grænseværdien er sjældne eller endnu ikke rapporteret.
English: This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100 % mortality).
Danish: Dette studie bekræftede fund fra et tidligere prospektivt studie, hvor der sås positivt resultat hos patienter med risikofaktorer for dårlig prognose, herunder graft-versus-host sygdom og i særdeleshed cerebrale infektioner (normalt forbundet med næsten 100 % mortalitet).