FrancophonIA/ELRC3.0 huggingface dataset:
English: • It is important to gradually reduce the dose over two weeks because this can help prevent a sudden increase in the levels of fat (called ‘triglycerides') in your blood.
Danish: • Det er vigtigt at nedsætte dosis gradvist over en periode på to uger, da det kan være med til at forebygge en pludselig stigning i blodets indhold af fedt (kaldet "triglycerider").
English: Signs of an allergic reaction can be seen in section 4 under “Allergic reactions”.
Danish: Du kan læse om tegn på en allergisk reaktion i punkt 4 under "Allergiske reaktioner".
English: Dose adjustments in children without metabolic abnormalities should primarily be made according to weight change.
Danish: Dosisjustering hos børn uden metaboliske abnormiteter bør primært foretages i forbindelse med vægtændring.
English: • The syringe you need to use to inject this medicine depends on the dose prescribed for you.
Danish: • Den sprøjte, du skal bruge til at injicere dette lægemiddel, afhænger af den dosis, der er ordineret til dig.
English: It is used in adults, adolescents and children 2 years or over:
Danish: Det bruges til voksne, unge og børn på 2 år og derover:
English: Anaphylactic reactions may follow immediately after administration of the medicine.
Danish: Anafylaktiske reaktioner kan opstå umiddelbart efter administration af lægemidlet.
English: Gradually reducing your dose, and following a reduced fat diet may help to prevent this.
Danish: En gradvis nedsættelse af dosis og en fedtfattig diæt kan være med til at forebygge dette.
English: • helping the insulin in your body manage sugar levels.
Danish: • hjælpe insulinen i kroppen med at styre blodsukkeret.
English: • If you weigh 40 kg or less:
Danish: • Hvis du vejer 40 kg eller mindre:
English: • Do not try to prepare the medicine or inject yourself if you have not been trained.
Danish: • Undlad at forsøge at klargøre lægemidlet eller injicere det selv, hvis du ikke er blevet oplært i det.
English: Leptin is a cytokine and has the potential to alter the formation of cytochrome P450 (CYP450) enzymes.
Danish: Leptin er et cytokin og kan potentielt ændre dannelsen af cytochrom P450-enzymer (CYP450).
English: See section 3 “How much to inject” for more information.
Danish: Se punkt 3 "Så meget skal du injicere" for at få flere oplysninger.
English: ● Fasting TG concentration > 2.26 mmol/L or postprandially elevated triglycerides
Danish: ● Fastetriglyceridkoncentration > 2,26 mmol/l eller postprandialt forhøjede triglycerider
English: A causal relationship between lymphoma and Myalepta has not been established.
Danish: Der er ikke fastlagt en årsagssammenhæng mellem lymfom og Myalepta.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: The most frequently occurring adverse reactions from the clinical studies were hypoglycaemia (14%) and weight decreased (17%).
Danish: De hyppigst forekommende bivirkninger fra de kliniske studier var hypoglykæmi (14 %) og vægttab (17 %).
English: • Women who could get pregnant should use effective contraception, including non-hormonal methods such as condoms, while using Myalepta.
Danish: • Kvinder, der kan blive gravide, skal bruge effektiv prævention, herunder barrieremetoder som for eksempel kondom, mens de bruger Myalepta.
English: A review of the patient's self-administration technique is recommended every 6 months whilst using Myalepta.
Danish: Det anbefales at gennemgå patientens selv-administrationsteknik hver 6. måned under behandling med Myalepta.
English: Signs of high and low blood sugar
Danish: Tegn på højt og lavt blodsukker
English: Sodium Hydroxide (for pH adjustment)
Danish: Natriumhydroxid (til justering af pH)
English: The effect of metreleptin on CYP450 enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted.
Danish: Virkningen af metreleptin på CYP450-enzymer kan være klinisk relevant for CYP450-substrater med smalt terapeutisk indeks, hvor dosis justeres individuelt.
English: Clinical trials of metreleptin did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.
Danish: Kliniske forsøg med metreleptin omfattede ikke et tilstrækkeligt antal patienter i alderen 65 og derover til at fastlægge, om deres respons er anderledes end yngre patienters.
English: You may have higher amounts of sugar (‘hyper-glycaemia') or fat (‘hyper-triglyceridaemia') in your blood while on Myalepta, which may be a sign that this medicine is not working as well as it should.
Danish: Du kan have højere mængder af sukker ("hyper-glykæmi") eller fedt ("hyper-triglyceridæmi") i blodet, mens du får Myalepta, og det kan være et tegn på, at lægemidlet ikke virker så godt, som det burde.
English: Reductions in HbA1c and TG may not be seen in children as metabolic abnormalities may not be present at the start of treatment.
Danish: Der ses muligvis ikke reduktion i HbA1c og triglycerider hos børn, da metaboliske abnormiteter muligvis ikke er til stede i starten af behandlingen.
English: • Metreleptin is similar to a human hormone called leptin.
Danish: • Metreleptin ligner et hormon hos mennesker, som kaldes leptin.
English: • If you inject other medicines, do not inject Myalepta in the same site as you have done for those other medicines.
Danish: • Hvis du injicerer andre lægemidler, må du ikke injicere Myalepta samme sted, som du har brugt til andre lægemidler.
English: Both had immunodeficiency and significant haematological abnormalities including severe bone marrow abnormalities before the start of treatment.
Danish: Begge havde immundefektsygdom og signifikante hæmatologiske abnormiteter, herunder svære knoglemarvsabnormiteter, inden påbegyndelse af behandlingen.
English: Adverse reactions are classified by MedDRA System Organ Class and absolute frequency in Table 7.
Danish: Bivirkningerne er klassificeret i henhold til MedDRA-systemorganklasse og absolut hyppighed i Tabel 7.
English: - Access to further materials, including training videos in multiple languages that will demonstrate each step to in preparing and administering Myalepta via a website.
Danish: - Adgang til andet materiale, herunder instruktionsvideoer på flere sprog via et websted, som demonstrerer de enkelte trin i klargøring og administration af Myalepta.
English: Do not use this medicine after the expiry date which is stated on the vial and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasset og pakningen.
English: The recommended daily dose of metreleptin is based on body weight as provided in Table 1.
Danish: Den anbefalede daglige dosis metreleptin er baseret på legemsvægt som angivet i Tabel 1.
English: See section 2 “How to stop using Myalepta” for more information.
Danish: Se punkt 2 "Hvis du skal holde op med at bruge Myalepta" for at få flere oplysninger.
English: Draft protocol to be submitted 6 months after notification of the European Commission decision
Danish: Et udkast til protokollen skal indsendes 6 måneder efter meddelelse af EuropaKommissionens afgørelse.
English: These events included 1 episode in 1 patient of serious and severe appendicitis, 2 episodes in patients of serious and severe pneumonia, a single episode of serious and severe sepsis and non-serious severe gingivitis in 1 patient and 6 episodes of serious and severe sepsis or bacteraemia and 1 episode of non-serious severe ear infection in 1 patient.
Danish: Disse hændelser omfattede 1 episode med alvorlig og svær appendicitis hos 1 patient, 2 episoder med alvorlig og svær pneumoni, en enkelt episode med alvorlig og svær sepsis og ikke-alvorlig svær gingivitis hos 1 patient samt 6 episoder med alvorlig og svær sepsis eller bakteriæmi og 1 episode med ikke-alvorlig svær øreinfektion hos 1 patient.
English: No studies with direct administration of metreleptin to juvenile animals have been conducted.
Danish: Der er ikke udført studier med direkte administration af metreleptin til ungdyr.
English: In particular, tell your doctor if you are taking any of the following medicines:
Danish: Du skal især fortælle det til lægen, hvis du tager nogen af følgende lægemidler:
English: Arthralgia, Myalgia
Danish: Artralgi, myalgi
English: In order to ensure patients and carers understand the correct dose to be injected, the prescriber should prescribe the appropriate dose both in milligrams and the volume in millilitres.
Danish: For at sikre, at patienter og plejepersoner forstår den korrekte dosis til injektion, skal den ordinerende læge ordinere den passende dosis i både milligram og volumen i milliliter.
English: • blood-thinning medicines (such as warfarin or phenprocoumon)
Danish: • blodfortyndende medicin (som for eksempel warfarin eller phenprocoumon)
English: In order to avoid medication errors including overdose, dose calculation and dose adjustment guidelines below should be followed.
Danish: For at undgå medicineringsfejl, herunder overdoser, skal retningslinjerne for dosisberegning og dosisjustering nedenfor følges.
English: • The needle should go as far into the ampoule as possible.
Danish: • Kanylen skal gå så langt ned i ampullen som muligt.
English: *Metreleptin is a recombinant human leptin analogue (produced in Escherichia coli cells by recombinant DNA technology to form recombinant methionyl-human leptin).
Danish: *Metreleptin er en rekombinant human leptin-analog (fremstillet i Escherichia coli-celler vha. rekombinant DNA-teknologi for at danne rekombinant methionyl-human leptin).
English: The maximum tolerated dose may be less than the maximum daily dose, outlined in Table 1, as evidenced by excessive weight loss, even if metabolic response is incomplete.
Danish: Den maksimalt tolererede dosis kan være mindre end den maksimale daglige dosis anført i Tabel 1, hvilket viser sig ved overdrevent vægttab, også selvom det metaboliske respons er ufuldstændigt.
English: You might also see smaller air bubbles in the syringe.
Danish: Det kan også være, at der er små luftbobler i sprøjten.
English: If clinical response is not seen after 6 months of treatment the physician should ensure that the patient is compliant with the administration technique, is receiving the correct dose and is adherent to diet.
Danish: Hvis der ikke ses klinisk respons efter 6 måneders behandling, skal lægen sikre, at patienten bruger den rette administrationsteknik, får den korrekte dosis og overholder sin diæt.
English: Only the metabolic effects of metreleptin have been studied.
Danish: Kun metreleptins metaboliske virkninger er blevet undersøgt.
English: • alcohol wipes (to clean your skin where you will inject and to clean the tops of the vials)
Danish: • spritservietter (til at rense huden, der hvor du skal injicere, og til at rense toppen af hætteglassene)
English: If a patient develops pancreatitis whilst being treated with metreleptin, it is advised that metreleptin be continued uninterrupted, as stopping treatment abruptly may exacerbate the condition.
Danish: Hvis en patient udvikler pancreatitis under behandling med metreleptin, tilrådes det at fortsætte behandlingen med metreleptin uden afbrydelser, da en pludselig afbrydelse af behandlingen kan forværre tilstanden.
English: Neutralising antibodies
Danish: Neutraliserende antistoffer
English: However, separate studies revealed that exposure of the mouse foetus to metreleptin was low (< 1%) after subcutaneous administration of metreleptin to pregnant mice.
Danish: Separate studier har dog vist, at eksponering af museføtus for metreleptin var lav (< 1 %) efter subkutan administration af metreleptin til drægtige mus.
English: All three patients had acquired generalised LD.
Danish: Alle tre patienter havde erhvervet generaliseret lipodystrofi.
English: o The need of compliance with treatment due to the risk of pancreatitis when medication is abruptly stopped.
Danish: o Behovet for komplians med behandlingen på grund af risikoen for pancreatitis ved en pludselig afbrydelse af behandlingen.
English: • Until the powder dissolves and the liquid is clear.
Danish: • Fortsæt, indtil pulveret er opløst, og væsken er klar.
English: • 15% reduction in triglycerides (TGs)
Danish: • 15 % reduktion i triglycerider.
English: Very common (may affect more than 1 in 10 people): • weight loss
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer): • vægttab.
English: Concomitant anti-diabetic and lipid-lowering dose regimens were not held constant during the study, but analyses showed no significant difference in efficacy between patients who had no increases or additions to their anti-diabetic or lipid-lowering treatments versus the overall study population.
Danish: Samtidige antidiabetika- og lipidsænkende dosisregimener var ikke konstante under studiet, men analyser viste ingen signifikant forskel i effekt mellem patienter, som ikke fik øget eller udvidet deres antidiabetika- eller lipidsænkende behandlinger, kontra den samlede studiepopulation.
English: Hypoglycaemia, deemed as related to metreleptin treatment, occurred in 14.2% of patients studied.
Danish: Hypoglykæmi vurderet som relateret til metreleptinbehandling forekom hos 14,2 % af studiepatienterne.
English: 24) To inject under the skin, pinch the skin with one hand where you are going to inject.
Danish: 24) For at injicere under huden skal du knibe huden sammen med den ene hånd på det sted, hvor du vil injicere.
English: Data from clinical trials do not support safety and efficacy in patients with HIV-related LD.
Danish: Data fra kliniske forsøg understøtter ikke sikkerhed og virkning hos patienter med hiv-relateret lipodystrofi.
English: • sharps disposal container (to safely dispose of the injection equipment afterwards)
Danish: • kanylebøtte (til sikker bortskaffelse af injektionsudstyret bagefter).
English: Metreleptin works by copying the effects of leptin.
Danish: Metreleptin virker ved at kopiere leptins virkning.
English: Prolonged gestation resulted in the death of some females during parturition and lower survival of offspring within the immediate postnatal period.
Danish: Forlænget gestation førte til dødsfald for nogle hunner under partus og lavere overlevelsesrater for afkom i den umiddelbare postnatale periode.
English: Step E: Choose and preparing where to inject
Danish: Trin E: Vælg og klargør et injektionssted
English: If you notice any of the symptoms referred to above and described further in section 4 of this leaflet, or you are not sure, talk to your doctor straight away.
Danish: Hvis du bemærker nogen af de symptomer, der er nævnt ovenfor og beskrevet yderligere i punkt 4 i denne indlægsseddel, eller hvis du er i tvivl, skal du tale med lægen med det samme.
English: Abrupt interruption and/or non-compliance with metreleptin dosing was suspected to have contributed to the occurrence of pancreatitis in 2 patients.
Danish: Pludselig afbrydelse af og/eller manglende compliance med dosering af metreleptin blev mistænkt for at have bidraget til forekomsten af pancreatitis hos 2 patienter.
English: Doses exceeding 1 mL can be administered as two injections (the total daily dose divided equally) to minimise potential injection site discomfort due to injection volume.
Danish: Doser på mere end 1 ml kan administreres som to injektioner (den totale daglige dosis opdelt i to lige store doser) for at minimere risikoen for ubehag på injektionsstedet på grund af injektionsvolumenet.
English: Prior to launch of Myalepta in each Member State the Marketing Authorisation Holder (MAH) must agree about 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 markedsføring af Myalepta i de enkelte medlemsstater skal indehaveren af markedsføringstilladelsen og den nationale kompetente myndighed blive enige om uddannelsesprogrammets indhold og format, herunder kommunikationsmedier, distributionsformer og alle andre aspekter af programmet.
English: People with lipodystrophy can get a type of blood cancer called lymphoma, whether or not they are using Myalepta.
Danish: Patienter med lipodystrofi kan få en form for blodkræft, der kaldes lymfom, uanset om de bruger Myalepta eller ej.
English: You may notice you develop a high temperature, accompanied by increasing tiredness
Danish: Det kan vise sig ved, at du får feber, ledsaget af øget træthed.
English: Do not inject into a muscle.
Danish: Undlad at injicere i en muskel.
English: Tell your doctor straight-away if you develop a high temperature, accompanied by increasing tiredness (see section 4).
Danish: Fortæl det straks til lægen, hvis du får feber ledsaget af stigende træthed (se punkt 4).
English: Since it cannot be excluded that metreleptin may reduce exposure to substrates of CYP3A through enzyme induction, the efficacy of hormonal contraceptives may be reduced if co-administered with metreleptin.
Danish: Da det ikke kan udelukkes, at metreleptin kan reducere eksponering for substrater af CYP3A via enzyminduktion, kan virkningen af hormonale kontraceptiva være reduceret ved samtidig administration med metreleptin.
English: If a patient misses a dose, the dose should be administered as soon as the omission is noticed and the normal dosing schedule resumed the next day.
Danish: Hvis patienten glemmer en dosis, skal den administreres, så snart forglemmelsen opdages, og det normale doseringsskema skal genoptages dagen efter.
English: Metreleptin exhibits no genotoxic potential and no proliferative or preneoplastic lesions were observed in mice or dogs following treatment up to 6 months.
Danish: Metreleptin udviser intet potentiale for genotoksicitet, og der blev ikke observeret nogen proliferative eller præneoplastiske læsioner hos mus eller hunde efter behandling i op til 6 måneder.
English: Important: Myalepta must be injected under the skin (‘subcutaneous').
Danish: Vigtigt: Myalepta skal injiceres under huden ("subkutant").
English: In the generalised LD group, the number of patients according to age group was as follows: 5 patients < 6 years (including a single patient < 2 years), 12 patients ≥ 6 to < 12 years and 28 patients aged ≥ 12 to < 18 years; in the partial LD subgroup, there were no patients < 12 years of age and 4 patients ≥ 12 to < 18 years.
Danish: I gruppen med generaliseret lipodystrofi var antallet af patienter efter aldersgruppe som følger: 5 patienter < 6 år (herunder en enkelt patient < 2 år), 12 patienter ≥ 6 til < 12 år og 28 patienter ≥ 12 til < 18 år; i undergruppen med partiel lipodystrofi var der ingen patienter < 12 år og 4 patienter ≥ 12 til < 18 år.
English: This leaflet was last revised in (month YYYY).
Danish: Denne indlægsseddel blev senest ændret (måned ÅÅÅÅ).
English: • medicines which suppress the immune system (such as cyclosporine)
Danish: • medicin, som undertrykker immunsystemet (som for eksempel ciclosporin)
English: • you are allergic to metreleptin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for metreleptin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Myalepta can affect the way some other medicines work.
Danish: Myalepta kan påvirke den måde, som visse andre lægemidler virker på.
English: Generally the majority of events could be managed by food intake with only relatively few modifications of anti-diabetic medicinal product dose occurring.
Danish: Generelt kunne størstedelen af hændelserne behandles med fødeindtag og kun relativt få modifikationer af antidiabetikadosis.
English: Specific clinical studies have not been conducted to assess the effect of age, gender, race, or body mass index on the pharmacokinetics of metreleptin in patients with lipodystrophy.
Danish: Der er ikke udført specifikke kliniske studier til vurdering af betydningen af alder, køn, race eller kropsmasseindeks på metreleptins farmakokinetik hos patienter med lipodystrofi.
English: A 4 to 5-fold increase in the t1/2 values was also observed in pregnant mice compared to non-pregnant mice.
Danish: Der blev også observeret en stigning på 4 til 5 gange i t1/2-værdierne for drægtige mus sammenlignet med ikke-drægtige mus.
English: • statins for reducing cholesterol (such as atorvastatin)
Danish: • statiner til at sænke kolesterolindholdet (for eksempel atorvastatin)
English: Healthcare professionals' educational material should contain:
Danish: Uddannelsesmaterialet til sundhedspersonale skal indeholde:
English: Increasing abnormalities of TG and HbA1c may be seen which may require a dose increase.
Danish: Der kan ses et øget antal abnormiteter vedrørende triglycerider og HBA1c, som kan kræve en dosisøgning.
English: • being clumsy and dropping things
Danish: • være klodset og tabe ting
English: Though not confirmed in clinical trials, neutralising antibodies could in theory affect the activity of endogenous leptin.
Danish: Det er ikke bekræftet i kliniske forsøg, men neutraliserende antistoffer kan i teorien påvirke aktiviteten af endogen leptin.
English: Metreleptin mimics the physiological effects of leptin by binding to and activating the human leptin receptor, which belongs to the Class I cytokine family of receptors that signals through the JAK/STAT transduction pathway.
Danish: Metreleptin efterligner leptins fysiologiske virkninger ved at binde sig til og aktivere human leptinreceptor, som tilhører klasse I-cytokinfamilien af receptorer, der signalerer gennem JAK/STAT-transduktionsvejen.
English: Two-year carcinogenicity studies in rodents have not been conducted.
Danish: Der er ikke udført toårige karcinogenicitetsstudier hos gnavere.
English: After IV administration, metreleptin clearance was shown to be 79.6 mL/kg/h in healthy volunteers.
Danish: administration viste metreleptins clearance sig at være 79,6 ml/kg/t hos raske frivillige.
English: Low blood sugar with insulin or other anti-diabetic medicines
Danish: Lavt blodsukker med insulin eller anden diabetesmedicin
English: Initiating or adjusting lipid lowering medications may be required.
Danish: Det kan være nødvendigt at initiere eller justere dosis af lipidsænkende lægemidler.
English: The glass ampoule is a sealed container.
Danish: Glasampullen er en forseglet beholder.
English: In partial LD patients, assessment across age groups is limited, due to the small sample size.
Danish: Hos patienter med partiel lipodystrofi er vurderingen på tværs af aldersgrupper begrænset som følge af det lille antal patienter.
English: This card will also include pictures of the relevant syringe sizes on which the doctor can draw a line to indicate on the volume of water for injection to use for reconstitution and the volume of reconstituted solution to inject.
Danish: Kortet skal også indeholde billeder af de relevante sprøjtestørrelser, hvorpå lægen kan tegne en streg for at angive, hvor meget vand til injektionsvæsker der skal bruges til rekonstitution, samt hvor meget rekonstitueret opløsning der skal injiceres.
English: • your body producing antibodies to metreleptin which may increase the risk of developing serious or severe infections.
Danish: • at din krop danner antistoffer mod metreleptin, som kan øge din risiko for at udvikle alvorlige eller svære infektioner.
English: Decreased maternal body weight was observed from gestation throughout lactation at all doses and resulted in reduced weight of offspring at birth, which persisted into adulthood.
Danish: Lavere maternel legemsvægt blev observeret fra gestation til laktation ved alle doser og førte til reduceret vægt hos afkommet ved fødslen, som fortsatte indtil voksenalderen.
English: ● Presence of diabetes mellitus, or
Danish: ● Tilstedeværelse af diabetes mellitus
English: Non-clinical data indicate renal clearance is the major route of metreleptin elimination, with no apparent contribution of systemic metabolism or degradation.
Danish: Prækliniske data indikerer, at renal clearance er metreleptins vigtigste eliminationsvej, og der er tilsyneladende intet bidrag fra systemisk metabolisme eller nedbrydning.