natgillin/translations-raw huggingface dataset:
Det gives som en 90-minutters infusion (drop) i en blodåre hver eller hver tredje uge til behandling af brystkræft og hver tredje uge til behandling af mavekræft.
It is given by infusion (drip) into a vein over 90 minutes every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer.
Kanjinti må kun anvendes, hvis kræften har såkaldt "overudtryk af HER2", dvs. hvis der på overfladen af kræftcellerne dannes store mængder af proteinet HER2.
Kanjinti can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Kanjinti er et "biosimilært lægemiddel".
Kanjinti is a ‘biosimilar medicine'.
• tidlige stadier af brystkræft (når kræften har spredt sig inde i brystet eller til kirtlerne under armen, men ikke til andre dele af kroppen) efter operation, kemoterapi (lægemidler til behandling af kræft) og strålebehandling.
• early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Ved tumorer, som er lokalt fremskredne (herunder inflammatoriske tumorer), eller som er mere end 2 cm brede, anvendes Kanjinti før operation i kombination med kemoterapi og igen efter operation som enkeltstofbehandling
For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Kanjinti is used before surgery in combination with chemotherapy and then again after surgery on its own;
Studier har også vist, at indgivelse af Kanjinti giver samme niveau af det aktive stof i kroppen som indgivelse af Herceptin.
Studies have also shown that giving Kanjinti produces similar levels of the active substance in the body to giving Herceptin.
Laboratoriestudier, der sammenligner Kanjinti med Herceptin, har vist, at det aktive stof i Kanjinti i vid udstrækning svarer til det aktive stof i Herceptin, hvad angår struktur, renhed og biologisk aktivitet.
Laboratory studies comparing Kanjinti with Herceptin have shown that the active substance in Kanjinti is highly similar to that in Herceptin in terms of structure, purity and biological activity.
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.
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.
Det var derfor agenturets opfattelse, at fordelene ved Kanjinti opvejer de identificerede risici, som for Herceptin, og kan godkendes.
Therefore, the Agency's view was that, as for Herceptin, the benefit of Kanjinti outweighs the identified risk and it can be authorised.
Kanjinti kan forårsage kardiotoksicitet (hjerteskade), herunder hjertesvigt (nedsat hjertefunktion).
Kanjinti can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Hvordan anvendes Kanjinti?
How is Kanjinti used?
Hvilke fordele viser studierne, at der er ved Kanjinti?
What benefits of Kanjinti have been shown in studies?
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.
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.
Hvordan virker Kanjinti?
How does Kanjinti work?
Disse resultater er relevante for andre populationer og administrationsveje.
These results are relevant to other populations and routes of administration.
Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
Frequency not known (cannot be estimated from available data)
Total parenteral ernæring:
Total parenteral nutrition:
Forligelighed med andre koncentrationer er ikke kendt.
Compatibility with other concentrations is unknown.
• Balance- eller koordinationsproblemer
• Problems with balance or coordination
Disse forsigtighedsregler gælder også for børn.
These precautions are also applicable to children.
1316 BN Almere Holland
1316 BN Almere The Netherlands
• De har haft en allergisk reaktion over for andre azoler.
• You have had an allergic reaction to other azoles.
Plasmaproteinbindingen anslås til 58 %.
Plasma protein binding is estimated to be 58 %.
58% af alle patienter blev underlagt myeloablative konditioneringsregimer.
From all patients 58% were subject to myeloablative conditions regimens.
Klinisk erfaring Positivt resultat defineres i dette afsnit som fuldstændigt eller delvis respons.
Clinical Experience Successful outcome in this section is defined as complete or partial response.
Profylakse bør påbegyndes på transplantationsdagen og kan administreres i op til 100 dage.
Prophylaxis should be initiated on the day of transplant and may be administered for up to 100 days.
Forskel i andele og 95% konfidensinterval (CI)
Difference in proportions and the 95% confidence interval (CI)
De kan blive skiftet fra intravenøs infusion til tabletter, så snart Deres tilstand forbedres.
You may be switched from the intravenous infusion to tablets once your condition improves.
Behandlingen bør være så kortvarig som muligt afhængigt af patientens kliniske og mykologiske respons.
Treatment duration should be as short as possible depending on the patient's clinical and mycological response.
Andre betydelige bivirkninger, hvis hyppighed ikke er kendt, men som De øjeblikkeligt skal fortælle til lægen:
Other significant side effects whose frequency is not known, but should be reported to your doctor immediately:
Læs denne indlægsseddel grundigt, inden De begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
I denne analyse var der succesfuld respons hos 41 % af patienterne i begge behandlingsarme.
In this analysis a successful response was seen in 41 % of patients in both treatment arms.
En asterix (*) indikerer en to-vejs-interaktion.
The asterisk (*) indicates a two-way interaction.
Det virker ved at dræbe eller stoppe væksten af de svampe, som forårsager infektioner.
It works by killing or stopping the growth of the fungi that cause infections.
Ikke undersøgt klinisk.
Not studied clinically.
Den rekonstituerede opløsnings pH-værdi er 4,0 til 7,0.
pH of the reconstituted solution is 4.0 to 7.0.
Det bruges til behandling af patienter (voksne og børn over 2 år) med:
It is used for the treatment of patients (adults and children over the age of 2) with:
Dette bør omfatte laboratorievurderinger, især serumkreatinin.
This should include laboratory evaluation, particularly serum creatinine.
Osmolalitet: 500 ± 50 mOsm/kg
Osmolality: 500± 50 mOsm/kg
For eksempel forventes det, at det hos 15-20 % af de asiatiske populationer metaboliseres dårligt.
For example, 15-20 % of Asian populations may be expected to be poor metabolisers.
Oral antikonception*
Oral Contraceptives*
Dette enzym viser genetisk polymorfi.
This enzyme exhibits genetic polymorphism.
Den gennemsnitlige behandlingsvarighed var 15 dage i begge behandlingsarme.
The median treatment duration was 15 days in both treatment arms.
Dette reducerede respons var dog ikke korreleret til højere MIC-værdier.
However, this reduced response was not correlated with elevated MICs.
Størstedelen (>94 %) af den totale radioaktivitet bliver udskilt i de første 96 timer efter både oral og intravenøs dosering.
The majority (> 94 %) of the total radioactivity is excreted in the first 96 hours after both oral and intravenous dosing.
Patienter med nyresvigt blev udelukket fra studiet.
Patients with renal failure were excluded from this study.
Der sås ikke klinisk signifikante forskelle, når sikkerhedsdata blev analyseret i relation til alder, race eller køn.
No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
• Lidelse, hvor kroppens immunsystem angriber dele af det perifere nervesystem
• A disorder in which the body's immune system attacks part of the peripheral nervous system
Derudover sås et succesrigt respons hos 1 ud af 3 patienter med infektioner forårsaget af mere end en organisme, herunder Scedosporium spp.
In addition, a successful response was seen in 1 of 3 patients with infections caused by more than one organism including Scedosporium spp.
Følgende instruktioner angår både behandling og profylakse.
The following instructions apply to both Treatment and Prophylaxis.
Patienter under 40 kg**
Patients less than 40 kg**
Myeloablative konditioneringsregimer
Myeloablative conditioning regimens
Yderligere 4 patienter havde en fusarium-infektion forårsaget af adskillige organismer; 2 af dem havde et succesrigt resultat.
Four additional patients with fusariosis had an infection caused by several organisms; two of them had a successful outcome.
7 Længerevarende optisk neuritis er rapporteret efter markedsføringen.
7 Prolonged optic neuritis has been reported post-marketing.
In vitro-aktivitet over for følgende patogener er vist, men den kliniske betydning er ukendt: Curvularia spp.
In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp.
Patienter med et nedsat immunsystem eller med svære infektioner kan have behov for langvarig behandling for at undgå, at infektionen kommer igen.
Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
Patienter skal undgå mulige farlige handlinger, såsom at føre bil eller betjene maskiner, mens de har disse symptomer.
Patients must avoid potentially hazardous tasks, such as driving or operating machinery while experiencing these symptoms.
• De lider af eller har lidt af en leversygdom.
• You are suffering from, or have ever suffered from liver disease.
Kliniske studier, der undersøger QTc-intervallet
Clinical studies examining QTc interval
Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er nævnt i pkt.
This medicinal product must not be mixed with other medicinal products except those mentioned in section
Deres læge kan ændre Deres dosis afhængig af Deres tilstand.
Your doctor may change your dose depending upon your condition.
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.
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.
Virkningsmekanismen er ukendt, skønt reaktionen med stor sandsynlighed sker i retina.
The mechanism of action is unknown, although the site of action is most likely to be within the retina.
Omhyggelig monitorering af blodglucose anbefales.
Careful monitoring of blood glucose is recommended.
Alle forsøg på at bestemme Candida til artsniveau skal derfor gøres.
Therefore, every attempt should be made to identify Candida to species level.
Data vedrørende klinisk virkning bliver understøttet af begrænsede data for følsomhed.
The clinical efficacy data were supported by limited susceptibility data.
ERG måler elektriske strømninger i retina.
The ERG measures electrical currents in the retina.
En forholdsmæssig større stigning i eksponering er set med stigende dosis.
Greater than proportional increase in exposure is observed with increasing dose.
Lægemiddel [interaktionsmekanisme]
Medicinal product [Mechanism of Interaction]
Den absolutte biotilgængelighed af voriconazol efter oral administration er anslået til 96 %.
The absolute bioavailability of voriconazole after oral administration is estimated to be 96 %.
Det kan forårsage forbigående og reversible ændringer af synet, herunder sløret, ændret/forøget visuel perception og/eller fotofobi.
It may cause transient and reversible changes to vision, including blurring, altered/enhanced visual perception and/or photophobia.
Profylakse bør være så kortvarig som muligt afhængigt af risikoen for udvikling af invasiv svampeinfektion (IFI) som defineret ved neutropeni eller immunsuppression.
Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
(Se bagest i indlægssedlen for yderligere oplysninger).
(Please refer to the end of this leaflet for further information).
Denne indlægsseddel fås på alle sprog i EU/EEA på languages på Det Europæiske Lægemiddelagenturs hjemmeside.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Karcinogenicitetsstudier er ikke udført med SBECD.
Carcinogenicity studies were not performed with SBECD.
Succesrigt respons blev set hos 24 patienter (15 med fuldstændigt, 9 med delvist respons).
Successful response was seen in 24 patients (15 complete, 9 partial responses).
Patienter bør monitoreres med henblik på udvikling af abnorm nyrefunktion.
Patients should be monitored for the development of abnormal renal function.
Af disse 7 patienter havde 3 patienter øjeninfektion, 1 havde sinusinfektion og 3 havde dissemineret infektion.
Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
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).
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).
Dato for første markedsføringstilladelse: { 27 maj 2015}
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {27 May 2015}
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.
However, as there were only 9 cases available for EUCAST analysis, there is currently insufficient evidence to set clinical breakpoints for C. krusei.
Medianvarigheden af profylaksen med studielægemidlet var 95,5 dage i MITT-gruppen.
The median duration of study drug prophylaxis was 95.5 days in the MITT group.
Identifikationstests og antimikrobiel følsomhedstests på disse isolater skal gentages, og såfremt resultatet bekræftes, skal isolatet sendes til et referencelaboratorium.
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.
1 Inkluderer febril neutropeni og neutropeni.
1 Includes febrile neutropenia and neutropenia.
Dosisjustering (voksne)
Dosage adjustment (Adults)
Efter rekonstituering skal den fortyndes yderligere før administration.
Once reconstituted further dilution is required before administration.
Den anbefalede dosis til voksne (også ældre patienter) er:
The recommended dose for adults (including elderly patients) is as follows:
- Påminde patienter om, hvornår og hvordan de skal indberette relevante tegn og symptomer på fototoksicitet og hudcancer.
- Reminds patients when and how to report relevant signs and symptoms of phototoxicity and skin cancer.
Rekonstitueres og fortyndes før brug.
Reconstitute and dilute before use.
Kompatible infusionsopløsninger: Den rekonstituerede opløsning kan fortyndes med:
Compatible Infusion Solutions: The reconstituted solution can be diluted with:
Forbigående hepatiske reaktioner, herunder hepatitis og gulsot, er set blandt patienter uden andre identificerbare risikofaktorer.
Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Denne urenhed bør anses for at være en substans med karcinogene egenskaber hos mennesker.
This impurity should be considered a substance with carcinogenic potential in humans.
Hos rotter, mus og hunde inducerede voriconazol også minimale adrenale forandringer.
In rats, mice and dogs, voriconazole also induced minimal adrenal changes.
Blandt kaukasiere og personer af negroid afstamning er prævalensen af personer med dårlig metaboliseringsevne 3-5 %.
For Caucasians and Blacks the prevalence of poor metabolisers is 3-5 %.
Kontakt Deres læge, hvis De oplever dette
Tell your docotor if you experience this.
Symptomerne opstod umiddelbart efter påbegyndt infusion (se også pkt.
Symptoms appeared immediately upon initiating the infusion (see section
Patienter 40 kg og derover**
Patients 40 kg and above**
Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendix V.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
• Behandling af alvorlige svampeinfektioner forårsaget af Scedosporium spp.
• Treatment of serious fungal infections caused by Scedosporium spp.
• Hudkræft
• Skin cancer
Det anbefales, at behandling initieres med intravenøs behandling, og at oral behandling først overvejes efter signifikant klinisk bedring.
It is recommended to initiate the therapy with intravenous regimen, and oral regimen should be considered only after there is a significant clinical improvement.
Geometrisk gennemsnitlig ændring (%)
Interaction Geometric mean changes (%)
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.
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.
• Kardiomyopati, især hvis hjerteinsufficiens er til stede.
• Cardiomyopathy, in particular when heart failure is present
Sikkerhedsprofilen og plasmakoncentrationerne, der blev observeret, var ens for såvel de mandlige som kvindelige patienter.
The safety profile and plasma concentrations observed in male and female patients were similar.
- Give aktuelle anbefalinger til læger og sundhedspersonale om overvågning og håndtering af disse risici.
- Provides HCPs with the current recommendations to monitor and manage these risks.
Den modificerede intent- totreat-gruppe (MITT-gruppe) omfattede 465 patienter, der havde fået allogen HSCT, hvoraf 45% havde AML.
The modified intent-to-treat (MITT) group included 465 allogeneic HSCT recipients with 45% of patients having AML.
Leverfunktionen bør monitoreres hos både børn og voksne.
Hepatic function should be monitored in both children and adults.
Bivirkninger med ikke kendt hyppighed: • Fregner og pigmentpletter.
Side effects with frequency not known: • Freckles and pigmented spots
Alvorlige refraktære Candida-infektioner
Serious refractory Candida infections
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”).
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”).
ERG-ændringerne progredierede ikke over 29 dages behandling og var fuldt reversible ved seponering af voriconazol.
The ERG changes did not progress over 29 days of treatment and were fully reversible on withdrawal of voriconazole.
Den rekonstituerede opløsning kan fortyndes med:
The reconstituted solution can be diluted with:
Profylakse hos voksne og børn
Prophylaxis in Adults and Children
Der foreligger ikke tilstrækkelige data til at give doseringsanbefalinger i denne situation (se punkt 4.5).
Currently there are insufficient data to allow dosing recommendations in this situation (see section 4.5).
• Eksisterende symptomatiske arytmier.
• Existing symptomatic arrhythmias
2 Inkluderer immun trombocytopenisk purpura.
2 Includes immune thrombocytopenic purpura.
Detaljeret information om dosisanbefalinger ses i følgende skema:
Detailed information on dosage recommendations is provided in the following table:
I kliniske studier var der 3 tilfælde af uforsætlig overdosering.
In clinical trials there were 3 cases of accidental overdose.
Farmakokinetik i specielle patientgrupper
Pharmacokinetics in special patient groups
Ud fra et mikrobiologisk synspunkt skal præparatet derfor bruges med det samme efter rekonstituering.
From a microbiological point of view, once reconstituted, the product must be used immediately.
Blodprodukter og korttidsinfusioner af elektrolytter:
Blood products and short-term infusion of concentrated solutions of electrolytes:
Tæt monitorering af protrombintid eller andre passende antikoagulationstest anbefales, og dosis af antikoagulantia bør tilsvarende justeres.
Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended, and the dose of anticoagulants should be adjusted accordingly.
• Blødning i øjet
• Bleeding in the eye
Utilstrækkelig evidens
Insufficient evidence
I lyset af disse data bør behandlingsvarigheden af den intravenøse lægemiddelform ikke overstige 6 måneder.
In the light of these data the duration of treatment of the intravenous formulation should be no longer than 6 months.
Patienter, som ikke blev vurderet 12 uger efter endt behandling (EOT), blev talt som behandlingssvigt.
Patients who did not have an assessment 12 weeks after EOT were counted as failures.
Forhøjede leverenzymer er også observeret oftere hos børn.
Elevated liver enzymes were also observed more frequently in children.
Kvinder i den fertile alder bør altid anvende effektiv antikonception under behandlingen.
Women of child-bearing potential must always use effective contraception during treatment.
Behandling må kun fortsættes i op til 180 dage efter transplantationen i tilfælde af vedvarende immunsuppression eller graft-versus-host sygdom (GvHD) (se pkt.
It may only be continued up to 180 days after transplantation in case of continuing immunosuppression or graft versus host disease (GvHD) (see section
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.
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.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning for at beskytte mod lys.
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
≤ S (følsom)
≤S (Susceptible)
1 Stammer med MIC-værdier højere end følsomheds-grænseværdien er sjældne eller endnu ikke rapporteret.
1 Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
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).
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).