FrancophonIA/ELRC3.0 huggingface dataset:
English: To avoid medication errors, prescribers will be given a guide specifying which strength and presentation to use and what details to include on each prescription.
Danish: For at undgå medicineringsfejl vil ordinerende læger blive forsynet med en vejledning, der specificerer, hvilken styrke og mundsprøjtestørrelse der skal anvendes, og hvilke oplysninger der skal angives på de enkelte recepter.
English: It works on insulin-producing cells in the pancreas and attaches to special channels on their surface called ATP-sensitive potassium channels (KATP channels), through which potassium ions normally enter the cells and trigger the release of insulin.
Danish: Det indvirker på de insulin-producerende celler i bugspytkirtlen og binder til de såkaldte ATP-følsomme kaliumkanaler (KATP-kanaler) på cellernes overflade, gennem hvilke kaliumioner normalt kommer ind i cellerne og udløser frigivelse af insulin.
English: • If the patient is switched to a different strength or a different oral syringe is appropriate, the prescriber should highlight to the parent or carer the packaging differences and carefully explain how to measure the new dose.
Danish: • Hvis patienten skiftes over til en ny styrke, eller hvis der skal anvendes en anden mundsprøjtestørrelse, bør den ordinerende læge tydeligt vise forælderen eller omsorgspersonen forskellen på pakningerne og omhyggeligt forklare, hvordan den nye dosis skal udmåles.
English: − If the volume per dose is more than 1 ml, the 5-ml oral syringe should be prescribed.
Danish: − Hvis volumen pr. dosis er over 1 ml, bør 5 ml-mundsprøjten ordineres.
English: − size of the oral syringe to be used.
Danish: − den mundsprøjtestørrelse, der skal anvendes.
English: • Parents and carers should always use Amglidia as advised by the doctor.
Danish: • Forældre og omsorgspersoner bør altid anvende Amglidia i henhold til lægens anvisninger.
English: • Pharmacists should ensure that the correct strength of Amglidia and the correct size of oral syringe are dispensed.
Danish: • Apotekspersonalet bør sørge for at udlevere den korrekte Amglidia-styrke og den korrekte mundsprøjtestørrelse.
English: When prescribing the medicine, the doctor will also specify the strength of Amglidia and the correct size of the oral syringe to give this dose accurately.
Danish: Når lægen ordinerer Amglidia, vil denne også specificere den korrekte styrke og den korrekte mundsprøjtestørrelse, så det sikres, at der indgives en korrekt dosis.
English: Healthcare professionals should also explain that the dose is to be given with the oral syringe graduated in ml, provided in the pack.
Danish: Lægen eller sundhedspersonalet bør også forklare, at dosen skal indgives med den ml-graduerede mundsprøjte, der følger med pakningen.
English: • Healthcare professionals should explain to the parent or carer that the dose of Amglidia is prescribed in ml according to the patient's body weight.
Danish: • Lægen eller sundhedspersonalet bør forklare forældre og omsorgspersoner, at Amglidia-dosen ordineres i ml ud fra patientens legemsvægt.
English: − If the volume per dose is equal to or less than 1 ml, the 1-ml oral syringe should be prescribed;
Danish: − Hvis volumen pr. dosis er 1 ml eller derunder, bør 1 ml-mundsprøjten ordineres.
English: It is important that only the syringe provided with the pack is used to measure Amglidia.
Danish: Det er vigtigt, at man kun bruger den sprøjte, der følger med pakningen, til at udmåle Amglidia-dosen.
English: • Amglidia is used to treat neonatal diabetes, a form of diabetes that occurs in the first 6 months of life.
Danish: • Amglidia anvendes til behandling af neonatal diabetes, der er en form for diabetes, som opstår i løbet af de første 6 måneder af livet.
English: Amglidia is a diabetes medicine used for neonatal diabetes, a form of diabetes that occurs in the first 6 months of life and that requires treatment with insulin.
Danish: Amglidia er et lægemiddel til behandling af neonatal diabetes, der er en form for diabetes, som opstår i løbet af de første 6 måneder af livet, og som kræver behandling med insulin.
English: Guide to be given to prescribers to ensure Amglidia is used correctly
Danish: Vejledning til ordinerende læger vedrørende korrekt anvendelse af Amglidia
English: • Amglidia is an oral suspension available in two strengths: 0.6 mg/ml and 6 mg/ml.
Danish: • Amglidia er en oral suspension, der fås i to styrker: 0,6 mg/ml og 6 mg/ml.
English: Amglidia is a medicine used for the treatment of neonatal diabetes, a form of diabetes that occurs in the first 6 months of life.
Danish: Amglidia er et lægemiddel, der anvendes til behandling af neonatal diabetes, der er en form for diabetes, som opstår i løbet af de første 6 måneder af livet.
English: It is a liquid to be given by mouth and is available in two strengths: 0.6 mg/ml and 6 mg/ml.
Danish: Det er en væske til indgivelse gennem munden, der fås i to styrker: 0,6 mg/ml og 6 mg/ml.
English: Amglidia 6 mg/ml should be used for doses higher than 0.6 mg/kg daily.
Danish: Amglidia i styrken 6 mg/ml bør anvendes til doser på over 0,6 mg/kg dagligt.
English: Once Amglidia is started, it is usually possible to reduce and even stop the dose of insulin the patient is already receiving.
Danish: Når Amglidiabehandlingen er iværksat, kan patientens insulindosis typisk reduceres efterhånden og måske helt seponeres.
English: • Parents and carers should use only the oral syringe provided with the package to measure the dose of Amglidia.
Danish: • Forældre og omsorgspersoner bør kun anvende den mundsprøjte, der følger med pakningen, til at udmåle Amglidia-dosen.
English: • Parents and carers will be advised by their healthcare professional on how to draw up the medicine into the oral syringe and give a dose to the child.
Danish: • Lægen eller sundhedspersonalet skal forklare forældre og omsorgspersoner, hvordan de trækker lægemidlet op i mundsprøjten og giver barnet en dosis.
English: • Only the oral syringe provided with the package should be used to measure the dose of Amglidia.
Danish: • Det er kun den mundsprøjte, der følger med pakningen, som må anvendes til at udmåle Amglidiadosen.
English: Each strength is available in two presentations: either with a 1-ml oral syringe or with a 5-ml oral syringe (see picture below).
Danish: Der fås to mundsprøjtestørrelser til hver styrke: en 1 ml-mundsprøjte og en 5 ml-mundsprøjte (se illustrationen nedenfor).
English: • Amglidia 0.6 mg/ml strength should only be used for doses up to 0.6 mg/kg daily.
Danish: • Amglidia i styrken 0,6 mg/ml må kun anvendes til doser på op til 0,6 mg/kg dagligt for at begrænse eksponeringen for hjælpestoffet natriumbenzoat.
English: There are two presentations for each strength: one with an oral syringe of 1 ml and one with an oral syringe of 5 ml (see picture above).
Danish: Der fås to mundsprøjtestørrelser til hver styrke: en 1 ml-mundsprøjte og en 5 ml-mundsprøjte.
English: Amglidia is available as an oral suspension in two strengths: 0.6 mg/ml and 6 mg/ml, and each strength is available in two presentations: either with a 1-ml oral syringe or with a 5-ml oral syringe.The strength and the size of the oral syringe to be used depends on the dose prescribed.
Danish: Amglidia 6 mg/ml med en 1 ml-mundsprøjte Amglidia 6 mg/ml med en 5 ml-mundsprøjte
English: Do not use in children under 18 years of age.
Danish: Må ikke anvendes til børn under 18 år.
English: Date of first authorisation: 31st August 2018
Danish: Dato for første markedsføringstilladelse: 31. august 2018
English: Observations with missing data were censored at the last date of assessment.
Danish: Observationer med manglende data blev censureret ved den sidste vurderingsdato.
English: You must also have previously been treated with trastuzumab.
Danish: Du skal også tidligere være behandlet med trastuzumab.
English: • Name of the product, active substance and approved indication of the product
Danish: • Produktnavn, aktivt stof og godkendt indikation for produktet
English: The course of treatment is one year.
Danish: Behandlingsforløbet varer ét år.
English: In this population, efficacy has not been demonstrated.
Danish: I denne population er effekten ikke påvist.
English: Approximately 75% of patients were re-consented for extended follow-up beyond 24 months.
Danish: Ca. 75 % af patienterne samtykkede til en forlænget opfølgning efter 24 måneder.
English: Talk to your doctor if:
Danish: Tal med din læge:
English: This helps to stop the cells from dividing and growing.
Danish: Dette hjælper med at stoppe cellerne med at dele sig og vokse.
English: • Any grade with complicated features†
Danish: • Enhver grad med komplikationer†
English: - Take the tablets with food.
Danish: - Tag tabletterne sammen med mad.
English: - Do not stop taking Nerlynx without talking to your doctor.
Danish: - Du må ikke holde op med at tage Nerlynx uden at tale med lægen.
English: - If you forget a dose, wait until the next day before you take the next dose.
Danish: - Hvis du har glemt at tage en dosis, skal du vente til næste dag, før du tager den næste dosis.
English: • For toxicities that result in a treatment delay > 3 weeks, or
Danish: • har toksiciteter, der medfører udskydelse af behandlingen > 3 uger, eller
English: The primary endpoint of the study was invasive disease-free survival (iDFS).
Danish: Det primære endepunkt i studiet var invasiv sygdoms-fri overlevelse (iDFS).
English: Nerlynx with food and drink
Danish: Brug af Nerlynx sammen med mad og drikke
English: There is no data in patients ≥85 years of age.
Danish: Der foreligger ingen data for patienter på 85 år eller derover.
English: - Take all the tablets with water, at about the same time each day, preferably in the morning.
Danish: - Tag alle tabletterne med et glas vand på omtrent samme tidspunkt hver dag, helst om morgenen.
English: No fertility studies in women or men have been conducted.
Danish: Der er ikke gennemført fertilitetsstudier hos kvinder eller mænd.
English: P-glycoprotein transporters
Danish: P-glykoprotein-transportører
English: Nerlynx should be taken with food, preferably in the morning.
Danish: Nerlynx bør tages sammen med mad, helst om morgenen.
English: There are no data from the use of Nerlynx in pregnant women.
Danish: Der er ingen data fra anvendelse af Nerlynx hos gravide kvinder.
English: Nerlynx is for oral use.
Danish: Nerlynx er til oral anvendelse.
English: This results in the cancer cells dividing and growing faster.
Danish: Dette medfører, at kræftcellerne deler sig og vokser hurtigere.
English: Nerlynx treatment should be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products.
Danish: Behandling med Nerlynx bør iværksættes og overvåges af en læge med erfaring i administration af kræftlægemidler.
English: The excretion was rapid and complete, with the majority of the radioactivity (61%) recovered within 96 hours and 98% recovered after 10 days.
Danish: Udskillelsen var hurtig og fuldstændig med størstedelen af radioaktiviteten (61 %) genfundet inden for 96 timer og 98 % genfundet inden for 10 dage.
English: Elderly No dose adjustment is required.
Danish: Ældre Der kræves ingen dosisjustering.
English: Tablet dimensions are 10.5 mm x 4.3 mm with thickness of 3.1 mm.
Danish: Tabletstørrelsen er 10,5 mm x 4,3 mm med en tykkelse på 3,1 mm.
English: The clinical status of the patient should be considered when assessing the patient's ability to perform tasks that require judgment, motor, or cognitive skills.
Danish: Patientens kliniske tilstand bør tages i betragtning ved vurdering af patientens evne til at udføre opgaver, der kræver dømmekraft eller motoriske eller kognitive evner.
English: This leaflet was last revised in MM/YYYY Other sources of information
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ Andre informationskilder
English: Median time from the last adjuvant trastuzumab treatment to randomization was 4.5 months.
Danish: Den mediane tid fra sidste adjuverende trastuzumabbehandling til randomisering var 4,5 måneder.
English: It is not known whether neratinib is excreted in human milk.
Danish: Det vides ikke, om neratinib udskilles i human mælk.
English: It helps control how a healthy breast cell grows.
Danish: Det hjælper med at styre, hvordan en rask brystcelle vokser.
English: Tests and checks for liver problems
Danish: Test og kontroller af leverproblemer
English: Grapefruit or grapefruit juice may also increase neratinib plasma concentrations and should be avoided.
Danish: Grapefrugt og grapefrugtjuice kan også øge plasmakoncentrationen af neratinib og bør derfor undgås.
English: Do not use Nerlynx if you notice any signs of damage to the packaging or if there are any signs of tampering (e.g., inner seal is broken).
Danish: Brug ikke Nerlynx, hvis du bemærker tegn på skader på pakningen, eller hvis der er tegn på, at den har været åbnet (f.eks. brudt indvendig forsegling).
English: The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of breast carcinoma.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier i alle undergrupper af den pædiatriske population for behandling af brystkræft.
English: It belongs to a group of medicines called ‘tyrosine kinase inhibitors' used to block cancer cells and treat breast cancer.
Danish: Det tilhører en gruppe af lægemidler, der kaldes "tyrosinkinasehæmmere", der anvendes til at blokere kræftceller og behandle brystkræft.
English: Clinical studies with BCRP substrates have not been conducted.
Danish: Der er ikke foretaget kliniske studier af BCRP-substrater.
English: - if you are allergic to neratinib or any of the other ingredients of this medicine (listed in
Danish: - hvis du er allergisk over for neratinib eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Patients should initiate treatment within 1 year after completion of trastuzumab therapy.
Danish: Patienterne bør begynde behandlingen inden for 1 år efter afslutning af trastuzumab-behandling.
English: Nerlynx dose modification is recommended based on individual safety and tolerability.
Danish: Dosisjustering anbefales baseret på den enkelte patients sikkerhed og tolerabilitet.
English: Population pharmacokinetic modelling revealed that creatinine clearance did not explain the variability between patients, hence, no dose modifications are recommended for patients with mild to moderate renal impairment.
Danish: Farmakokinetisk populationsmodellering viste, at kreatininclearance ikke forklarede variabiliteten mellem patienter, og der anbefales derfor ingen dosisjustering hos patienter med let til moderat nedsat nyrefunktion.
English: It is not known if elimination is as unchanged drug or metabolites.
Danish: Det vides ikke, om elimineringen sker som uomdannet stof eller metabolitter.
English: Your doctor will do blood tests before and during your treatment with Nerlynx.
Danish: Lægen vil undersøge dit blod før og under behandlingen med Nerlynx.
English: The clearance values of digoxin were equivalent following digoxin and digoxin plus neratinib.
Danish: Værdierne for digoxin-clearance var ækvivalente efter digoxin og digoxin plus neratinib.
English: Paediatric population There is no relevant use of Nerlynx in the paediatric population in the indication breast cancer.
Danish: Pædiatrisk population Der er ingen relevant brug af Nerlynx i den pædiatriske population ved indikationen brystkræft.
English: The ‘HER2 receptor' is a protein found on the surface of cells in the body.
Danish: HER2-receptoren er et protein, der findes på overfladen af celler i kroppen.
English: The safety of Nerlynx and how effective it is has not been studied in this age group.
Danish: Sikkerheden og virkningen af Nerlynx i denne aldersgruppe er ikke undersøgt.
English: Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Table 1, Table 2, Table 3, and Table 4.
Danish: Behandling af visse bivirkninger kan kræve afbrydelse af behandlingen og/eller dosisreduktion som vist i tabel 1, tabel 2, tabel 3 og tabel 4.
English: - Your doctor will also tell you if you need to change the dose of Nerlynx because of diarrhoea.
Danish: - Lægen vil også fortælle dig, om du skal ændre dosen af Nerlynx pga. diarré.
English: For hormone receptor positive patients, the relative treatment benefit of Nerlynx within pre-specified patient subgroups is presented in Figure 2.
Danish: For hormonreceptor-positive patienter er den relative behandlingsfordel ved Nerlynx inden for præspecificerede patient-undergrupper vist i figur 2.
English: Nerlynx should not be used during pregnancy unless the clinical condition of the woman requires treatment with neratinib.
Danish: Nerlynx bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver anvendelse af neratinib.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Nerlynx.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med lægen eller apotekspersonalet, før du tager Nerlynx.
English: There was no difference in frequency of SAEs in the Skin SOC between Asian and Caucasian subgroups.
Danish: Der var ingen forskel i hyppighed af alvorlige bivirkninger i systemorganklassen "Hud og subkutane væv" mellem de asiatiske og kaukasiske undergrupper.
English: In HER2-positive breast cancer, the cancer cells have a large amount of HER2 receptors on their surface.
Danish: Ved HER2-positiv brystkræft har kræftcellerne en stor mængde HER2-receptorer på deres overflade.
English: • Diarrhoea recurs to Grade 2 or higher at 120 mg per day
Danish: • Diarréen recidiverer til grad 2 eller derover ved 120 mg pr. dag
English: This is because the grapefruit may interact with Nerlynx and affect how the medicine works.
Danish: Det skyldes, at grapefrugt kan interagere med Nerlynx og påvirke den måde, som lægemidlet virker på.
English: Talk to your doctor before taking Nerlynx if you are breast-feeding or plan to breast-feed because small amounts of this medicine may pass into your breast milk.
Danish: Tal med din læge, før du tager Nerlynx, hvis du ammer eller planlægger at amme, da små mængder af dette lægemiddel kan udskilles i modermælk.
English: Package leaflet: Information for the patient Nerlynx 40 mg film-coated tablets neratinib This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Nerlynx 40 mg filmovertrukne tabletter neratinib Dette lægemiddel er underlagt supplerende overvågning.
English: Distribution Binding of neratinib to human plasma proteins, including covalent binding to human serum albumin (HSA), was greater than 98% and independent of concentration.
Danish: Neratinibs binding til humane plasmaproteiner, herunder kovalent binding til humant serumalbumin (HSA), var over 98 % og uafhængig af koncentration.
English: In the event of an overdose, administration should be withheld and general supportive measures undertaken.
Danish: I tilfælde af overdosering bør behandlingen tilbageholdes, og der skal gives almindelig understøttende behandling.
English: A 6-month carcinogenicity study in Tg.rasH2 transgenic mice and the rat 2-year data showed no signs of carcinogenic potential.
Danish: Et karcinogenicitetsstudie over 6 måneder hos Tg.rasH2-transgene mus og data fra et studie over 2 år med rotter viste ingen tegn på karcinogent potentiale.
English: Prior to launch of Nerlynx in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden Nerlynx lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen indgå en aftale med den relevante nationale myndighed om indholdet og formatet af informationsmaterialet, herunder kommunikationsmedier, distributionsmåder og alle øvrige aspekter af programmet.
English: Left ventricular dysfunction has been associated with HER2 inhibition.
Danish: Venstre ventrikel dysfunktion er blevet forbundet med HER2-hæmning.
English: • Relevant information of Gastrointestinal toxicity (diarrhoea) (e.g. signs and symptoms to be detailed (seriousness, severity, frequency, time to onset, duration, risks and consequences))
Danish: • Relevante oplysninger om gastrointestinal toksicitet (diarré) (f.eks. detaljer om tegn og symptomer (alvorlighed, sværhedsgrad, hyppighed, tid til debut, varighed, risici og konsekvenser))
English: Effects of neratinib on other substances
Danish: Indvirkningen af neratinib på andre stoffer
English: Oval, red film-coated tablet with ‘W104' debossed on one side.
Danish: Oval, rød filmovertrukket tablet med "W104" præget på den ene side.
English: Mannitol (E421) Microcrystalline cellulose Crospovidone Povidone
Danish: Mannitol (E421) Mikrokrystallinsk cellulose Crospovidon
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt France
Danish: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt Frankrig
English: Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.).
Danish: En række andre situationer kan også medføre dosisjustering som klinisk indiceret (f.eks. uacceptable toksiciteter, vedvarende grad 2-bivirkninger osv.).
English: Carcinogenesis, mutagenesis Nerlynx was neither clastogenic nor mutagenic in the standard battery of genotoxicity studies.
Danish: Karcinogenese, mutagenese Neratinib var hverken klastogent eller mutagent i et standardbatteri af genotoksiske studier.
English: The MAH shall ensure that in each Member State where Nerlynx is marketed, all healthcare professionals who are expected to prescribe/dispense Nerlynx, as well as all patients/carers who are expected to use Nerlynx, have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal i alle de medlemsstater, hvor Nerlynx markedsføres, sikre, at alle sundhedspersoner, som forventes at ordinere/administrere Nerlynx, samt alle patienter/omsorgspersoner, som forventes at anvende Nerlynx, har adgang til/får udleveret følgende informationpakke:
English: 1 Event-free rates for all endpoints, except for CNS recurrence for which cumulative incidence is reported.
Danish: 1 Hændelsesfri frekvenser for alle endepunkter, undtagen CNS-recidiv, for hvilket den kumulative incidens er rapporteret.
English: Nerlynx can cause changes in liver function - these are shown in blood tests.
Danish: Nerlynx kan forårsage ændringer i leverfunktionen, som kan ses i blodprøver.
English: Concomitant treatment with substances that increase gastric pH should be avoided, as neratinib solubility and absorption may decrease.
Danish: Samtidig behandling med stoffer, der øger den gastriske pH, bør undgås, da opløseligheden og absorptionen af neratinib kan falde.
English: The median cumulative duration of any grade diarrhoea was 59 days and the median cumulative duration of Grade 3 diarrhoea was 5 days.
Danish: Den mediane kumulative varighed af diarré, uanset grad, var 59 dage, og den mediane kumulative varighed af grad 3-diarré var 5 dage.
English: • Grade 4 diarrhoea [life-threatening consequences; urgent intervention indicated]
Danish: • Grad 4-diarré [livstruende konsekvenser, akut intervention indiceret]
English: • carbamazepine, phenobarbital, phenytoin (antiepileptics)
Danish: • carbamazepin, phenobarbital, phenytoin (antiepileptika)
English: A risk to the breast-fed infant cannot be excluded.
Danish: En risiko for ammede nyfødte/spædbørn kan ikke udelukkes.
English: Hormone receptor positive patients, disease-free survival by patient subgroup
Danish: Hormonreceptor-positive patienter, sygdomsfri overlevelse pr. patientundergruppe
English: • Fail to recover to Grade 0 to 1 from treatment-related toxicity,
Danish: • ikke opnår bedring til grad 0-1 af behandlingsrelateret toksicitet