FrancophonIA/ELRC3.0 huggingface dataset:
English: The importance of tapering the dose of Myalepta over two weeks if it is to be discontinued.
Danish: Vigtigheden af at nedtrappe dosis af Myalepta over to uger, hvis behandlingen skal seponeres.
English: Based on clinical response (e.g. inadequate metabolic control) or other consideration (e.g. tolerability issues, excessive weight loss especially in paediatric patients), the dose may be decreased, or increased to the maximum dose listed in Table 1.
Danish: På baggrund af det kliniske respons (f.eks. utilstrækkelig metabolisk kontrol) eller andre overvejelser (f.eks. problemer med tolerabilitet, overdrevent vægttab især hos pædiatriske patienter) kan dosis nedsættes eller øges til den maksimale dosis anført i Tabel 1.
English: • The glass ampoule should be at a 45 degree angle to the ground.
Danish: • Glasampullen skal være i en 45-graders vinkel i forhold til gulvet.
English: • stomach area (abdomen), except for a 5 cm area directly around the belly button
Danish: • maven, undtagen et område på 5 cm direkte rundt om navlen
English: When small doses/volumes are prescribed (e.g. in children), the vials will remain almost completely filled with product after withdrawal of the required dose.
Danish: Ved ordination af små doser/volumener (f.eks. til børn) vil hætteglasset være næsten helt fuldt, når den nødvendige dosis er udtaget.
English: Treatment should be initiated and monitored by a healthcare professional experienced in the diagnosis and management of metabolic disorders.
Danish: Behandlingen bør initieres og monitoreres af sundhedspersonale med erfaring i diagnosticering og behandling af stofskifteforstyrrelser.
English: Pack sizes of 1 or 30 vials.
Danish: Pakningsstørrelser med 1 eller 30 hætteglas.
English: While being treated with Myalepta, your body might produce antibodies which may increase the risk of developing serious or severe infections.
Danish: Mens du er i behandling med Myalepta, vil din krop muligvis danne antistoffer, som kan øge risikoen for at udvikle alvorlige eller svære infektioner.
English: ● back of the upper arm
Danish: • bagsiden af overarmen
English: While the impact of neutralising antibodies on efficacy has not been confirmed, consideration should be given by the prescriber to have patients tested for the presence of neutralising antibodies if there is significant loss of efficacy despite Myalepta administration.
Danish: Da neutraliserende antistoffers indflydelse på virkningen ikke er blevet bekræftet, skal den ordinerende læge overveje at få patienten testet for tilstedeværelse af neutraliserende antistoffer, hvis der opstår signifikant tab af virkning på trods af administration af Myalepta.
English: - Detailed instructions for use.
Danish: - En detaljeret brugsanvisning.
English: • you have ever had inflammation of an organ called the pancreas (‘pancreatitis')
Danish: • du nogensinde har haft betændelse i et organ, der kaldes bugspytkirtlen (pancreas)
English: • If there is medicine left in the syringe, you have not had your full dose.
Danish: • Hvis der er lægemiddel tilbage i sprøjten, har du ikke fået den fulde dosis.
English: • The needle is short in length, and all of the needle should go into the skin at a 45 degree angle.
Danish: • Kanylen er kort, og hele kanylen skal gå ind i huden i en vinkel på 45 grader.
English: Serious and/or severe infections that were temporally associated with > 80% blocking activity against metreleptin occurred in 5 generalised LD patients.
Danish: Alvorlige og/eller svære infektioner, som midlertidigt blev forbundet med > 80 % blokerende aktivitet mod metreleptin, forekom hos 5 patienter med generaliseret lipodystrofi.
English: You and your doctor will decide whether or not to continue breast-feeding while using this medicine.
Danish: Du og din læge vil beslutte, om du skal fortsætte med at amme, mens du bruger dette lægemiddel.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, amino acids and derivatives, ATC code: A16AA07
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte, aminosyrer og derivater, ATC-kode: A16AA07
English: • A sudden increase in the amount of triglyceride in your blood can make your pancreas inflamed (‘pancreatitis').
Danish: • En pludselig stigning i mængden af triglycerider i blodet kan medføre betændelse i din bugspytkirtel ("pancreatitis").
English: Patients were eligible for inclusion if they were > 6 months old, with a leptin level of < 12 ng/mL, and had at least 1 of the following 3 metabolic abnormalities:
Danish: Patienterne kunne deltage i studiet, hvis de var > 6 måneder gamle, havde leptinniveauer < 12 ng/ml og havde mindst 1 af følgende 3 metaboliske abnormiteter:
English: Reproductive toxicity studies have not included toxicokinetics analysis.
Danish: Studier af reproduktionstoksicitet omfattede ikke toksikokinetiske analyser.
English: Talk to a doctor straight away if you notice any allergic reactions, including:
Danish: Tal med lægen med det samme, hvis du bemærker en allergisk reaktion, herunder:
English: • You must remove an air pocket and air bubbles from the syringe to make sure you get the correct amount of sterile water in the syringe.
Danish: • Du skal fjerne eventuelle luftlommer og luftbobler fra sprøjten for at sikre, at du får den rette mængde sterilt vand i sprøjten.
English: In order to address the potential safety concerns and/or lack of efficacy related to immunogenicity of Myalepta, the applicant should submit an integrated analysis of immunogenicity measured according to validated assays.
Danish: For at håndtere de potentielle sikkerhedsproblemer og/eller mangel på virkning i forbindelse med Myaleptas immunogenicitet skal ansøgeren indsende en integreret analyse af immunogenicitet målt i overensstemmelse med validerede assays.
English: Remove the vial from the refrigerator and allow the vial to warm for 10 minutes to reach room temperature (20 °C-25 °C) prior to reconstitution.
Danish: Tag hætteglasset ud af køleskabet, og lad det stå ude i 10 minutter, indtil det har stuetemperatur (20 °C-25 °C), inden rekonstitution.
English: • theophylline used in lung problems such as asthma
Danish: • theophyllin brugt ved problemer med lungerne som for eksempel astma
English: After dissolving the vial contents in
Danish: Efter opløsning af hætteglassets indhold i
English: ● Actual change from baseline in HbA1c at Month 12, and
Danish: ● Faktisk ændring fra baseline i HbA1c ved måned 12 og
English: These findings are considered to be related indirectly to metreleptin pharmacology, resulting in nutritional deprivation of treated animals, and also possibly, due to an inhibitory effect on spontaneous and oxytocin-induced contractions, as has been observed in strips of human myometrium exposed to leptin.
Danish: Disse fund anses for at være indirekte relateret til metreleptins farmakologi, som resulterer i underernæring af behandlede dyr og muligvis også som følge af en inhibitorisk virkning på spontane og oxytocin-inducerede kontraktioner, som det er blevet observeret med stykker af humant myometrium eksponeret for leptin.
English: o T-cell lymphoma - Acquired LDs are associated with autoimmune disorders.
Danish: o T-cellelymfom - Erhvervede lipodystrofier er forbundet med autoimmune sygdomme.
English: Two of these patients were diagnosed with peripheral T-cell lymphoma while receiving the medicinal product.
Danish: To af disse patienter fik diagnosen perifert T-cellelymfom, mens de var i behandling med lægemidlet.
English: Your doctor may decide that you inject yourself.
Danish: Din læge kan beslutte, at du selv skal give injektionerne.
English: Injection site reactions were reported in 3.4% of patients with LD treated with metreleptin.
Danish: Reaktioner på injektionsstedet blev rapporteret for 3,4 % af patienter med lipodystrofi behandlet med metreleptin.
English: Very limited data are available for children, especially less than 6 years, with generalised LD.
Danish: Der foreligger stærkt begrænsede data om børn, især yngre end 6 år, med generaliseret lipodystrofi.
English: Dose adjustments should be made based on clinical response (see section 4.4).
Danish: Dosisjusteringer skal foretages på baggrund af klinisk respons (se pkt.
English: There are limited data on the pharmacokinetics of metreleptin in patients with lipodystrophy and therefore no formal exposure-response analysis has been performed.
Danish: Der findes begrænsede data om metreleptins farmakokinetik hos patienter med lipodystrofi, og derfor er der ikke udført en formel analyse af eksponering/respons.
English: The individual patient dose = 1.5 mg
Danish: Den enkelte patients dosis = 1,5 mg
English: 13) Hold the vial at 45 degree angle to the table and slowly push the plunger all the way down with your thumb.
Danish: 13) Hold hætteglasset i en 45-graders vinkel i forhold til bordet, og skub langsomt stemplet helt i bund med tommelfingeren.
English: 26) Gently insert the needle into the skin at approximately a 45 degree angle to the body.
Danish: 26) Indfør forsigtigt kanylen i huden med en vinkel på ca. 45 grader i forhold til kroppen.
English: Animal studies showed no adverse effects on male or female fertility (see section 5.3).
Danish: Dyrestudier har ikke vist negative virkninger på mænds eller kvinders fertilitet (se pkt.
English: • who have partial lipodystrophy which is inherited (also called congenital or familial lipodystrophy)
Danish: • som har arvelig partiel lipodystrofi (kaldes også medfødt, kongenit eller familiær lipodystrofi)
English: Talk to your doctor, pharmacist or nurse before using Myalepta if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Myalepta, hvis:
English: In clinical trials, antidrug antibodies (ADA) to metreleptin occurred very commonly (88%) in patients.
Danish: I kliniske forsøg forekom antistoffer (ADA, antidrug antibodies) mod metreleptin meget hyppigt (88 %) hos patienterne.
English: Do not stop using Myalepta without talking to your doctor.
Danish: Du må ikke holde op med at bruge Myalepta uden at tale med lægen.
English: o See the “Instructions for Use” to find out which syringe to use.
Danish: o Se "Instruktioner vedrørende anvendelsen" for at få oplysninger om, hvilken sprøjte du skal bruge.
English: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above
Danish: • med bekræftet kongenit generaliseret lipodystrofi (Berardinelli-Seips syndrom) eller erhvervet generaliseret lipodystrofi (Lawrences syndrom), hos voksne og børn i alderen 2 år og derover
English: These differences across age groups are likely related to differences in mean HbA1c at baseline, which was in the normal range for patients < 6 years (5.7%) and lower in patients ≥ 6 to < 12 years (6.4%) compared to the older age group (9.7%).
Danish: Disse forskelle på tværs af aldersgrupper er sandsynligvis relateret til forskelle i middel-HbA1c ved baseline, som var i normalområdet for patienter < 6 år (5,7 %) og lavere for patienter ≥ 6 til < 12 år (6,4 %) sammenlignet med den ældre aldersgruppe (9,7 %).
English: Always use a new syringe.
Danish: Brug altid en ny sprøjte.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Myalepta in one or more subsets of the paediatric population in the treatment of lipodystrophy (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Myalepta i en eller flere undergrupper af den pædiatriske population ved behandling af lipodystrofi (se pkt.
English: 8) Check the amount of water for injection
Danish: 8) Kontroller mængden af vand til injektionsvæsker
English: In clinical studies, hypoglycaemia has been managed with food/drink intake and by modifying the dose of anti-diabetic medicinal product.
Danish: I kliniske studier er hypoglykæmi blevet behandlet med indtagelse af mad eller drikke samt ved at modificere dosen af antidiabetikummet.
English: In this case, prolonged overdose was associated with severe anorexia causing vitamin and zinc deficiencies, iron deficiency anaemia, protein calorie malnutrition, and poor weight gain, which resolved following supportive treatment and dose adjustment.
Danish: I dette tilfælde var den langvarige overdosis forbundet med svær anoreksi, som medførte vitamin- og zinkmangel, jernmangelanæmi, protein- og energiunderernæring samt ringe vægtøgning, hvilket blev afhjulpet efter passende behandling og dosisjustering.
English: Consideration should also be given by the prescriber to have patients tested for the presence of neutralising antibodies.
Danish: Den ordinerende læge skal også overveje at få patienten testet for tilstedeværelse af neutraliserende antistoffer.
English: If you need to inject 1 mL or more of Myalepta solution, your doctor might tell you to give the dose as two separate injections.
Danish: Hvis du skal injicere 1 ml eller mere af Myalepta-opløsning, kan lægen have fortalt dig, at du skal indgive dosis som to separate injektioner.
English: • Carefully push the plunger back up to force the air out of the syringe.
Danish: • Skub forsigtigt stemplet opad for at tvinge luften ud af sprøjten.
English: • pain below the ribs like heartburn or indigestion
Danish: • have smerter under ribbenene ligesom halsbrand eller fordøjelsesbesvær
English: • a feeling of general discomfort, uneasiness or pain (‘malaise')
Danish: • en følelse af generelt ubehag, utilpashed eller smerter
English: Signs of high fat
Danish: Tegn på højt fedtindhold
English: In a supportive trial in LD patients, the median Tmax was 4 hours (range: 2 to 6 hours; N = 5) following single-dose administration of metreleptin.
Danish: I et understøttende forsøg med lipodystrofi-patienter var median Tmax 4 timer (interval: 2 til 6 timer; n = 5) efter administration af en enkelt dosis metreleptin.
English: • swelling of your face, lips, tongue or throat
Danish: • hævelser af ansigt, læber, tunge eller svælg
English: The reconstituted solution will take less than 5 minutes to become clear.
Danish: Den rekonstituerede opløsning bliver klar på under 5 minutter.
English: Women of childbearing potential should be advised that Myalepta may increase fertility and should be encouraged to use contraception.
Danish: Fertile kvinder skal informeres om, at Myalepta kan øge fertiliteten, og opfordres til at bruge antikonception.
English: The AUC exposure of pregnant mice was approximately 2 to 3 times greater than observed in non-pregnant mice after 10 mg/kg subcutaneous administration of metreleptin.
Danish: AUC-eksponering for drægtige mus var ca. 2 til 3 gange større end observeret hos ikke-drægtige mus efter subkutan administration af 10 mg/kg metreleptin.
English: 0.300 mL 0.30 mL *Note: Initial and dose increments should be rounded down to the nearest 0.01 mL
Danish: 0,30 ml *Bemærk: Den indledende dosis og dosisøgninger skal rundes ned til nærmeste 0,01 ml
English: • Do not touch the area you have cleaned until you are injecting Myalepta.
Danish: • Rør ikke ved det rensede område, før du injicerer Myalepta.
English: • a glass vial (with rubber stopper)
Danish: • et hætteglas af glas (med gummiprop)
English: • The active substance is metreleptin.
Danish: • Aktivt stof: metreleptin.
English: - HCPs should provide training to patients on the correct technique.
Danish: - Sundhedspersonalet skal instruere patienterne om korrekt teknik.
English: Myalepta might increase fertility in women with lipodystrophy (see section “Pregnancy, breast-feeding and fertility”).
Danish: Myalepta kan gøre kvinder med lipodystrofi mere frugtbare (se punktet "Graviditet, amning og frugtbarhed").
English: If your syringe looks different or has different dose markings, talk to your doctor, nurse or pharmacist for more information.
Danish: Hvis din sprøjte ser anderledes ud, eller hvis den har andre dosismarkeringer, skal du tale med lægen, sundhedspersonalet eller apotekspersonalet for at få flere oplysninger.
English: Myalepta is an injection once a day under the skin (‘subcutaneous injection').
Danish: Myalepta gives som en injektion en gang om dagen under huden ("subkutan injektion").
English: • Hold the bottom of the ampoule in one hand and the top of the ampoule in your other hand.
Danish: • Hold i bunden af ampullen med den ene hånd, og tag fat i toppen af ampullen med den anden hånd.
English: If you notice any of the symptoms above, or you are not sure, talk to your doctor straight away.
Danish: Hvis du bemærker nogen af symptomerne ovenfor, eller hvis du er i tvivl, skal du tale med lægen med det samme.
English: All events reported in clinical studies in patients with LD have been mild or moderate in severity and none have led to treatment discontinuation.
Danish: Alle hændelser, der er rapporteret i kliniske studier med patienter med lipodystrofi, har været af sværhedsgraden let eller moderat, og ingen har medført seponering af behandlingen.
English: 23) Clean the area where you will inject yourself with a clean alcohol swab and let the skin dry.
Danish: 23) Rens området med en ren spritserviet, der hvor du vil injicere, og lad huden tørre.
English: Healthcare professionals should provide patients and carers with training on the reconstitution of the product and proper subcutaneous injection technique, so as to avoid intramuscular injection in patients with minimal subcutaneous adipose tissue.
Danish: Sundhedspersonalet skal instruere patienter og plejepersoner i rekonstitution af produktet og korrekt teknik til subkutan injektion for at undgå intramuskulær injektion hos patienter med minimalt subkutant fedtvæv.
English: • feeling more sleepy or confused
Danish: • føle sig mere søvnig eller forvirret
English: o The requirement to perform regular follow-ups with the patient/carer to ensure continued correct and compliant Myalepta reconstitution and treatment.
Danish: o Kravet om at gennemføre regelmæssige opfølgninger med patienten/omsorgspersonen for at sikre fortsat korrekt og kompliant rekonstitution af og behandling med Myalepta.
English: What you need to know before you use Myalepta 3.
Danish: Det skal du vide, før du begynder at bruge Myalepta 3.
English: • Sometimes, large spaces of air (air pockets) get caught inside the syringe.
Danish: • Nogle gange kan der blive fanget luft inde i sprøjten (luftlommer).
English: Consider dose increase before stopping treatment.
Danish: En dosisøgning skal overvejes, inden behandlingen stoppes.
English: Myalepta reconstituted with water for injection is for single use only and should be administered immediately.
Danish: Myalepta, der er rekonstitueret med vand til injektionsvæsker, er til engangsbrug og skal administreres med det samme.
English: o If your dose is more than 5 mg, your doctor, nurse or pharmacist might tell you to give the dose as two separate injections.
Danish: o Hvis din dosis er over 5 mg, kan lægen, sundhedspersonalet eller apotekspersonalet have fortalt dig, at du skal indgive dosen som to separate injektioner.
English: All patients had a history of pancreatitis and hypertriglyceridaemia.
Danish: Alle patienter havde en anamnese med pancreatitis og hypertriglyceridæmi.
English: You should not stop using Myalepta unless your doctor tells you to.
Danish: Du må ikke holde op med at bruge Myalepta, medmindre lægen beder dig om det.
English: A total of 148 patients with generalised and partial LD received metreleptin during clinical studies.
Danish: I alt 148 patienter med generaliseret og partiel lipodystrofi fik metreleptin under kliniske studier.
English: The maximum daily dose in males and females is 10 mg or 2 mL injection volume
Danish: Den maksimale daglige dosis for mænd og kvinder er 10 mg eller 2 ml injektionsvolumen.
English: • blood pressure medicines called ‘calcium channel blockers'
Danish: • blodtryksmedicin kaldet "calcium-antagonister"
English: A blocking activity of the reaction between metreleptin and a recombinant leptin receptor has been observed in vitro in the blood of the majority of an extended set of patients (98 out of 102 patients or 96%) but the impact on the efficacy of metreleptin could not be clearly established.
Danish: Der er observeret en blokerende aktivitet i reaktionen mellem metreleptin og en rekombinant leptinreceptor in vitro i blod fra de fleste af et udvidet sæt patienter (98 ud af 102 patienter eller 96 %), men påvirkningen af metreleptins virkning er ikke klarlagt.
English: Patients and carers should be advised to be aware of the signs and symptoms of hypoglycaemia.
Danish: Patienter og omsorgspersoner skal instrueres i at være opmærksomme på tegn og symptomer på hypoglykæmi.
English: Signs of high blood sugar levels and high fat levels are listed in section 4 under “Signs of high and low blood sugar” and “Signs of high fat”.
Danish: Du kan læse om tegn på højt blodsukker og højt fedtindhold i blodet i punkt 4 under "Tegn på højt og lavt blodsukker" og "Tegn på højt fedtindhold".
English: For all patients weighing more than 40 kg an incremental adjustment increase in daily dose would be 1.25 mg or 0.25 mL injection volume.
Danish: For alle patienter, som vejer mere end 40 kg, vil en trinvis øgning af den daglige dosis være 1,25 mg eller 0,25 ml injektionsvolumen.
English: 25) With the other hand, hold the syringe like a pencil.
Danish: 25) Hold sprøjten som en blyant med den anden hånd.
English: No formal metabolism studies have been conducted.
Danish: Der er ikke udført formelle metabolismestudier.
English: In patients with serious and severe infections, continuation of metreleptin should be at the discretion of the prescriber.
Danish: Hos patienter med alvorlige og svære infektioner bør beslutningen om at fortsætte med metreleptin tages af den ordinerende læge.
English: Always use a new ampoule or vial of water for injection each time when preparing to dissolve Myalepta powder.
Danish: Brug altid en ny ampul eller et nyt hætteglas med vand til injektionsvæsker, hver gang du gør klar til opløsning af Myalepta-pulver.
English: • medicines for epilepsy or fits (such as phenytoin)
Danish: • medicin mod epilepsi eller anfald (som for eksempel phenytoin)
English: • blood clot in your veins (deep vein thrombosis) - pain, swelling, warmth & redness, usually occurring in lower leg or thigh
Danish: • blodprop i en blodåre (dyb venetrombose) - smerter, hævelse, varme og rødmen, som regel i læggen eller låret
English: Read the “Instructions for Use” (see section 7) for how to make the solution before injecting.
Danish: Læs "Instruktioner vedrørende anvendelsen" (se punkt 7) for at få oplysninger om, hvordan du fremstiller opløsningen inden injektion.
English: Total daily volume to be injected is 3.75 mg/5 = 0.75 mL.
Danish: Det samlede volumen til injektion dagligt er 3,75 mg/5 = 0,75 ml.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and supportive treatment initiated.
Danish: I tilfælde af overdosering skal patienten monitoreres tæt for tegn og symptomer på bivirkninger, og passende behandling iværksættes.
English: Abdominal pain upper, Diarrhoea, Pancreatitis, Vomiting
Danish: Smerter i øvre abdomen, diarré, pancreatitis, opkastning
English: Myalepta is available in packs containing 1 or 30 vials.
Danish: Myalepta fås i pakninger med 1 eller 30 hætteglas.
English: In order to further evaluate the long-term safety and effectiveness of Myalepta under normal conditions of clinical practice, the applicant should establish a registry including all patients with generalised or partial lipodystrophy treated with Myalepta according to an agreed protocol.
Danish: For yderligere at evaluere Myaleptas sikkerhed og virkning på længere sigt under normale forhold i klinisk praksis skal ansøgeren oprette et register over alle patienter med generaliseret eller partiel lipodystrofi, som får behandling med Myalepta i henhold til en aftalt protokol.
English: Dose decreases based on weight loss may be made weekly.
Danish: Dosis kan nedsættes ugentligt baseret på vægttab.