FrancophonIA/ELRC3.0 huggingface dataset:
English: • A dose card on which the doctor can write for the patient the dose in mg, ml (and where appropriate units from a 0.3 ml U100 insulin syringe).
Danish: • Et dosiskort, hvor lægen kan skrive dosis i mg eller ml (og hvis relevant, enheder fra en 0,3 ml U100-insulinsprøjte) til patienten.
English: If you cannot contact your doctor, you should seek emergency medical help:
Danish: Hvis du ikke kan komme i kontakt med lægen, skal du kontakte skadestuen:
English: Among the 39 patients with generalised LD who were receiving insulin at baseline, 16 (41%) were able to discontinue insulin use altogether after starting metreleptin.
Danish: Blandt de 39 patienter med generaliseret lipodystrofi, som fik insulin ved baseline, kunne 16 (41 %) seponere brug af insulin helt efter påbegyndelse af metreleptin.
English: If you want to use the same area of the body for each injection, do not use the same spot that you used for your last injection.
Danish: Hvis du vil bruge det samme område på kroppen til alle injektioner, må du ikke bruge det samme sted to gange i træk.
English: Metreleptin dose increases in adults and children based on incomplete clinical response can be considered after a minimum of 6 months of treatment, allowing for lowering concomitant insulin, oral anti-diabetic and/or lipid lowering medication.
Danish: Øgninger af metreleptindosis hos voksne og børn baseret på ufuldstændigt klinisk respons kan overvejes efter mindst 6 måneders behandling, hvilket giver mulighed for at nedsætte dosis af samtidig insulin, antidiabetika og lipidsænkende lægemidler.
English: 10) Make sure the vial of Myalepta powder has been out of the refrigerator for at least 10 minutes to reach room temperature.
Danish: 10) Sørg for, at hætteglasset med Myalepta har stået uden for køleskab i mindst 10 minutter, så det har fået stuetemperatur.
English: • going to the toilet to pass urine more often
Danish: • skulle lade vandet oftere
English: Tell your doctor straight-away if you have any symptoms of an allergic reaction.
Danish: Fortæl det straks til lægen, hvis du får symptomer på en allergisk reaktion.
English: The MAH shall ensure that in each Member State where Myalepta is marketed, all healthcare professionals and patients/carers who are expected to use Myalepta are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at der i alle medlemsstater, hvor Myalepta markedsføres, udleveres den følgende uddannelsespakke til alt sundhedspersonale og alle patienter/omsorgspersoner, der forventes at bruge Myalepta:
English: It is unknown whether metreleptin or its metabolites are excreted in human milk.
Danish: Det er ukendt, om metreleptin/metabolitter udskilles i human mælk.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: The once daily dose of Myalepta can be increased by increments as shown in Table 6 to a maximum daily dose.
Danish: Doser af Myalepta, der administreres en gang dagligt, kan øges i trin, som vist i Tabel 6, til den maksimale daglige dosis.
English: The greater metreleptin exposure and longer t1/2 observed in the pregnant animals may be related to a reduced elimination capacity by binding to soluble leptin receptor found at higher levels in pregnant mice.
Danish: Den større metreleptineksponering og længere t1/2, der blev observeret hos drægtige dyr, kan være relateret til en reduceret eliminationsevne, som skyldes binding til opløselig leptin-receptor, som drægtige mus har højere niveauer af.
English: 27) Gently use your thumb to push the plunger all the way down.
Danish: 27) Brug tommelfingeren til forsigtigt at skubbe stemplet helt i bund.
English: • with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
Danish: • med bekræftet familiær partiel lipodystrofi eller erhvervet partiel lipodystrofi (Barraquer-Simons syndrom), hos voksne og børn i alderen 12 år og derover, som ikke har kunnet opnå tilstrækkelig metabolisk kontrol med standardbehandling.
English: Unplanned pregnancies may occur due to restoration of luteinizing hormone (LH) release, see section
Danish: Ikke planlagte graviditeter kan forekomme som følge af genoprettelse af udskillelsen af luteiniserende hormon (LH).
English: • increased fat in the blood (‘triglycerides')
Danish: • øget indhold af fedt i blodet ("triglycerider")
English: ● Fasting insulin concentration > 30 μU/mL, or
Danish: ● Fasteinsulinkoncentration > 30 μE/ml
English: Remove the needle and syringe from the vial and gently swirl the contents to reconstitute, until the liquid is clear.
Danish: Fjern kanylen og sprøjten fra hætteglasset, og sving forsigtigt indholdet rundt for at rekonstituere, indtil væsken er klar.
English: “Instructions for Use” (section 7) for more information on reading and using the different syringes.
Danish: Se "Instruktioner vedrørende anvendelsen" (punkt 7) for at få flere oplysninger om, hvordan du aflæser og bruger de forskellige sprøjter.
English: Upon initiation or discontinuation of metreleptin, in patients being treated with these types of agents, therapeutic monitoring of effect (e.g., warfarin), or drug concentrations (e.g. cyclosporin or theophylline) should be performed and the individual dose of the agent adjusted as needed.
Danish: Efter initiering eller seponering af metreleptin hos patienter, som behandles med denne type midler, bør der iværksættes monitorering for virkning (f.eks. warfarin) eller lægemiddelkoncentration (f.eks. ciclosporin eller theophyllin), og den enkelte patients dosis skal justeres efter behov.
English: • medicines for sleep or anxiety called ‘benzodiazepines'
Danish: • sovemedicin eller angstdæmpende medicin kaldet "benzodiazepiner".
English: Line up the top rim of the plunger with the line for the prescribed dose.
Danish: Lad stemplets øverste kant flugte med stregen for den ordinerede dosis.
English: Myalepta has minor influence on the ability to drive and use machines.
Danish: Myalepta påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: • The vials may remain almost completely filled with product after withdrawal of the required dose.
Danish: • Hætteglasset vil måske være næsten helt fuldt, når den nødvendige dosis er udtaget.
English: The cake of lyophilised powder should be intact and white in colour.
Danish: Det kompakte lyofiliserede pulver skal være intakt og hvidt.
English: In a pre- and postnatal development study in mice, metreleptin caused prolonged gestation and dystocia at all tested doses, starting at, approximately, a dose identical to the maximum recommended clinical dose, based on body surface area of a 60 kg patient.
Danish: I et studie af præ- og postnatal udvikling i mus medførte metreleptin forlænget gestation og dystoki ved alle testede doser, startende med en dosis, som er omtrent identisk med den maksimale anbefalede kliniske dosis, baseret på et legemsoverfladeareal for en patient, som vejer 60 kg.
English: Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:
Danish: Myalepta er indiceret som supplement til diæt som substitutionsterapi til behandling af komplikationerne ved leptinmangel hos patienter med lipodystrofi:
English: Patients/carers educational material should contain:
Danish: Uddannelsesmaterialet til patienter/omsorgspersoner skal indeholde:
English: Change from Baseline at Month 12
Danish: Ændring fra baseline ved måned 12
English: Total daily volume to be injected is total dose in mg/5.
Danish: Det samlede daglige volumen til injektion er den samlede dosis i mg/5.
English: If you use more Myalepta than you should, talk to your doctor or go to a hospital straight away.
Danish: Hvis du har brugt for meget Myalepta, skal du tale med en læge eller tage direkte på hospitalet.
English: Hence, the pharmacokinetics may be altered in patients with renal impairment.
Danish: Derfor vil farmakokinetikken muligvis være ændret hos patienter med nedsat nyrefunktion.
English: The median fasting leptin concentration at baseline was 5.9 ng/mL (1.6-16.9) using the LINCO RIA test method.
Danish: Den mediane fastekoncentration af leptin ved baseline var 5,9 ng/ml (1,6-16,9) vha. LINCO RIA-testmetoden.
English: A dose increment of 1.25 mg increases the daily dose to 3.75 mg.
Danish: En dosisøgning på 1,25 mg øger den daglige dosis til 3,75 mg.
English: Before you begin self-administering this medicine at home, your doctor, nurse or pharmacist will train you how to prepare and inject Myalepta.
Danish: Inden du giver dig selv dette lægemiddel derhjemme, vil lægen, sundhedspersonalet eller apotekspersonalet oplære dig i, hvordan du klargør og injicerer Myalepta.
English: Overall, 30 (97%) patients were female, 26 (84%) were Caucasian, 2 (7%) Hispanic, and 0 Black.
Danish: I alt var 30 (97 %) patienter kvinder, 26 (84 %) var kaukasiere, 2 (7 %) var af latinamerikansk oprindelse, og 0 var sorte.
English: Non-clinical data based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity reveal no risks additional to those attributed to an excess of the expected pharmacodynamic responses, such as loss of appetite and body weight.
Danish: Vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet viser prækliniske data ingen risici udover de, der tilskrives et overskud af de forventede farmakodynamiske responser, som for eksempel manglende appetit og vægttab.
English: If you need to stop using Myalepta, your doctor will gradually reduce the dose over two weeks.
Danish: Hvis du er nødt til at holde op med at bruge Myalepta, vil lægen nedsætte din dosis gradvist over to uger.
English: • To help with injecting Myalepta solution using the small 0.3 mL syringe, the last column in the table below shows the ‘Unit' measurement on the syringe that relates to the different potential doses of the medicine prescribed by your doctor, nurse, or pharmacist.
Danish: • Som hjælp ved injektion af Myalepta-opløsning med den lille 0,3 ml-sprøjte viser den sidste kolonne i tabellen nedenfor målingen i "enheder" på sprøjten, der svarer til de forskellige mulige doser af lægemidlet, som lægen, sundhedspersonalet eller apotekspersonalet har ordineret.
English: 7) Remove any air pocket or air bubbles.
Danish: 7) Fjern eventuelle luftlommer eller luftbobler.
English: A separate case of anaplastic large cell lymphoma was reported in a paediatric patient receiving the medicinal product who did not have haematological abnormalities before treatment.
Danish: Der blev rapporteret et separat tilfælde af anaplastisk storcellelymfom hos en pædiatrisk patient, der fik lægemidlet, som ikke havde hæmatologiske abnormiteter inden behandlingen.
English: Overall, 51 (77%) patients were female, 31 (47%) were Caucasian, 11 (17%) Hispanic, and 16 (24%) Black.
Danish: I alt var 51 (77 %) patienter kvinder, 31 (47 %) var kaukasiere, 11 (17 %) var af latinamerikansk oprindelse, og 16 (24 %) var sorte.
English: The median duration of metreleptin treatment was 2.4 years (range: 6.7 months-14.0 years).
Danish: Den mediane varighed af metreleptinbehandling var 2,4 år (interval: 6,7 måneder-14,0 år).
English: 0.3 mL U100 Insulin Syringe
Danish: 0,3 ml U100 insulinsprøjte
English: The median duration of metreleptin treatment was 4.2 years (range: 3.4 months-13.8 years).
Danish: Den mediane varighed af metreleptinbehandling var 4,2 år (interval: 3,4 måneder-13,8 år).
English: Using the glass ampoule
Danish: Ved brug af glasampullen
English: • low blood sugar (glucose)
Danish: • lavt blodsukker (glukose)
English: • fluid in your lungs - difficulty breathing or cough
Danish: • væske i lungerne - vejrtrækningsbesvær eller hoste
English: Myalepta has minor influence on the ability to drive and use machines due to fatigue and dizziness.
Danish: Myalepta påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner på grund af træthed og svimmelhed.
English: Table 7 Adverse reactions reported with Myalepta in > 1 patient during clinical studies in generalised LD and the subgroup of partial LD patients and post-marketing experience System Organ Class
Danish: Tabel 7 Bivirkninger rapporteret med Myalepta hos > 1 patient under kliniske studier med patienter med generaliseret lipodystrofi og undergruppen med partiel lipodystrofi samt erfaringer efter markedsføring
English: • Inject all of the medicine.
Danish: • Injicer alt lægemidlet.
English: • If you see an air pocket or any air bubbles, follow the same instructions described in step 7 to remove the air from the syringe.
Danish: • Hvis der er luftlommer eller luftbobler, skal du følge instruktionerne i trin 7 for at fjerne luft fra sprøjten.
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 patients but the impact on the efficacy of metreleptin could not be clearly established (see section 4.8).
Danish: Der er observeret en blokerende aktivitet i reaktionen mellem metreleptin og en rekombinant leptinreceptor in vitro i blod fra de fleste patienter, men påvirkningen af metreleptins virkning kunne ikke klart fastslås (se pkt.
English: The syringe will now be facing up.
Danish: Sprøjten vender nu opad.
English: The patient will also receive separately the solvent for reconstitution (i.e. water for injection), the syringes/needles for reconstitution, the syringes/needles for administration, the cleansing alcohol swabs, and a sharps disposal container.
Danish: Patienten får også separat opløsningen til rekonstitution (dvs. vand til injektionsvæsker), sprøjter/kanyler til rekonstitution og administration, spritservietter til afrensning samt en kanylebøtte.
English: Table 2 Dose calculation Weight and gender Starting dose calculation
Danish: Tabel 2 Dosisberegning Vægt og køn
English: Acute pancreatitis associated with discontinuation of Myalepta
Danish: Akut pancreatitis forbundet med seponering af Myalepta
English: • swelling or bleeding under the skin (‘haemorrhage')
Danish: • hævelser eller blødninger under huden ("hæmoragi")
English: This will include for example instructions for handling possible ADRs.
Danish: Dette omfatter for eksempel instruktioner i håndtering af mulige bivirkninger.
English: One serious and severe infection of appendicitis was temporally associated with blocking activity against metreleptin in a patient with partial LD who was not in the subgroup of partial LD patients.
Danish: Én alvorlig og svær infektion (appendicitis) blev midlertidigt forbundet med blokerende aktivitet mod metreleptin hos en patient med partiel lipodystrofi, som ikke var i undergruppen af patienter med partiel lipodystrofi.
English: • very fast heartbeat
Danish: • meget hurtige hjerteslag.
English: This medicine is for use in children aged 2 years and above, adolescents and adults with generalised lipodystrophy; it is also for use in children aged 12 years and above, adolescents and adults with partial lipodystrophy.
Danish: Dette lægemiddel kan bruges af børn i alderen 2 år og derover, unge og voksne med generaliseret lipodystrofi, og det kan også bruges af børn i alderen 12 år og derover, unge og voksne med partiel lipodystrofi.
English: The median age at baseline was 15 years (range: 1-68 years), with 45 (68%) patients being less than 18 years of age.
Danish: Den mediane alder ved baseline var 15 år (interval: 1-68 år), og 45 (68 %) patienter var under 18 år.
English: Take your time to carefully prepare and inject your medicine, which when including the period of the vial warming up after being taken out of the fridge, can be approximately 20 minutes in total.
Danish: Når man medregner den tid, det tager for hætteglasset at få stuetemperatur, efter at du har taget det ud af køleskabet, kan det tage ca. 20 minutter i alt.
English: • pain in the chest or back
Danish: • have smerter i brystkassen eller ryggen
English: Aegerion Pharmaceuticals B.V. Atrium Building 8th Floor
Danish: Atrium Building 8th Floor
English: - Lymphoproliferative disorders, including lymphoma have been reported in patients with acquired generalised LD not treated with Myalepta.
Danish: - Lymfoproliferative sygdomme, herunder lymfomer, er blevet rapporteret hos patienter med erhvervet generaliseret lipodystrofi, som ikke fik behandling med Myalepta.
English: Following reconstitution with water for injections, the medicinal product must be used immediately and cannot be stored for future use.
Danish: Efter rekonstitution med vand til injektionsvæsker skal lægemidlet anvendes med det samme og må ikke gemmes til senere brug.
English: The reconstituted solution should be injected into the abdomen, thigh or upper arm tissue.
Danish: Den rekonstituerede opløsning skal injiceres i væv i abdomen, låret eller overarmen.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration should be permanently discontinued immediately and appropriate therapy initiated.
Danish: Hvis der forekommer en anafylaktisk reaktion eller en anden alvorlig allergisk reaktion, skal administration straks seponeres permanent, og passende behandling iværksættes.
English: See steps 6-8 below on removal of air pockets and air bubbles from the syringe.
Danish: Se trin 6-8 nedenfor for at få oplysninger om, hvordan du fjerner eventuelle luftlommer og luftbobler fra sprøjten.
English: The mechanism for pancreatitis in these patients was presumed to be return of hypertriglyceridaemia and therefore increased risk of pancreatitis in the setting of discontinuation of effective therapy for hypertriglyceridaemia.
Danish: Årsagen til pancreatitis hos disse patienter blev antaget at være tilbagevenden af hypertriglyceridæmi med deraf følgende forhøjet risiko for pancreatitis i forbindelse med seponering af virkningsfuld behandling af hypertriglyceridæmi.
English: Myalepta is used to treat the complications of not having enough leptin in patients with lipodystrophy.
Danish: Myalepta anvendes til at behandle komplikationerne ved mangel på leptin hos patienter med lipodystrofi.
English: If you have injected less Myalepta than you should, talk to your doctor straight away.
Danish: Hvis du har injiceret for lidt Myalepta, skal du tale med en læge med det samme.
English: • muscle pain (‘myalgia')
Danish: • muskelsmerter ("myalgi")
English: Pruritus, Rash, Urticaria
Danish: Pruritus, udslæt, urticaria
English: How much to inject
Danish: Så meget skal du injicere
English: The Applicant should conduct this integrated analysis according to an agreed protocol including samples from all available historical samples from previous studies (NIH991265/20010769, FHA 101, NASH4 and obesity studies) with patients with GL/PL and samples obtained from patients that will be included in the efficacy and safety study in PL patients, the paediatric investigational plan (PIP) study and the patients registry.
Danish: Ansøgeren skal gennemføre denne integrerede analyse i henhold til en aftalt protokol indeholdende udsnit af alle tilgængelige historiske prøver fra tidligere studier (NIH991265/20010769, FHA 101, NASH4 og studier af overvægt) med patienter med generaliseret lipodystrofi eller partiel lipodystrofi samt prøver fra patienter, som vil blive inkluderet i studiet af virkning og sikkerhed hos patienter med partiel lipodystrofi, PIP-studiet (pædiatrisk undersøgelsesplan) samt patientregisteret.
English: During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed.
Danish: Under nedtrapningen skal triglyceridniveauerne monitoreres, og det skal overvejes at initiere eller justere dosis af lipidsænkende lægemidler efter behov.
English: Using the glass vial or plastic ampoule
Danish: Ved brug af hætteglasset af glas eller plastampullen
English: • The top rim of the plunger should line up with the black line on the syringe that matches the amount of Myalepta solution you are going to inject.
Danish: • Stemplets øverste kant skal flugte med den sorte streg på sprøjten, som svarer til den mængde Myalepta-opløsning, du skal injicere.
English: The median age at baseline was 38 years (range: 15-64 years), with 5 (16%) patients being less than 18 years of age.
Danish: Den mediane alder ved baseline var 38 år (interval: 15-64 år), og 5 (16 %) patienter var under 18 år.
English: Metreleptin may decrease insulin resistance in diabetic patients, resulting in hypoglycaemia in patients with LD and co-existing diabetes.
Danish: Metreleptin kan nedsætte diabetespatienters insulinresistens, hvilket fører til hypoglykæmi hos patienter med lipodystrofi og samtidig diabetes.
English: What you need to know before you use Myalepta Do not use Myalepta if:
Danish: Det skal du vide, før du begynder at bruge Myalepta Brug ikke Myalepta:
English: If you need to stop using Myalepta, your doctor will gradually reduce the dose over two weeks before stopping it altogether.
Danish: Hvis du er nødt til at holde op med at bruge Myalepta, vil lægen nedsætte din dosis gradvist over to uger, før du helt holder op med at bruge lægemidlet.
English: Following single subcutaneous doses of 0.01 to 0.3 mg/kg metreleptin in healthy adult subjects, the half-life was 3.8 to 4.7 hours.
Danish: Efter enkelte subkutane doser på 0,01 til 0,3 mg/kg metreleptin administreret til raske voksne forsøgspersoner var halveringstiden 3,8 til 4,7 timer.
English: Do not give this medicine to children below the age of 2 years with generalised lipodystrophy, or below the age of 12 years with partial lipodystrophy.
Danish: Giv ikke denne medicin til børn under 2 år med generaliseret lipodystrofi eller børn under 12 år med partiel lipodystrofi.
English: 29) Throw away the two used syringes and all caps, vials, or ampoules in the sharps disposal container straight away.
Danish: 29) Læg de to brugte sprøjter og alle hætter, hætteglas eller ampuller i kanylebøtten med det samme.
English: EXP After reconstitution: use immediately.
Danish: EXP Anvendes straks efter rekonstitution.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Myalepta should be permanently discontinued immediately and appropriate therapy initiated.
Danish: Hvis der forekommer en anafylaktisk reaktion eller en anden alvorlig allergisk reaktion, skal administration af Myalepta straks seponeres permanent, og passende behandling iværksættes.
English: o To know how much solution to inject (in Units), divide your dose (in mg) by 5, and then times it by 100.
Danish: o For at finde ud af, hvor meget opløsning du skal injicere (i enheder), skal du dividere dosis (i mg) med 5 og gange med 100.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Myalepta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Myalepta skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Remaining reconstituted product should be discarded after use.
Danish: Resterende rekonstitueret produkt skal kasseres efter brug.
English: In studies of healthy adult subjects, following intravenous administration of metreleptin, leptin volume of distribution (endogenous leptin and metreleptin) was approximately 4 to 5 times plasma volume; volumes (mean ± SD) were 370 ± 184 mL/kg, 398 ± 92 mL/kg, and 463 ± 116 mL/kg for 0.3, 1.0, and 3.0 mg/kg/day doses, respectively.
Danish: I studier med raske voksne forsøgspersoner var leptins fordelingsvolumen (endogen leptin og metreleptin) efter intravenøs administration af metreleptin ca. 4 til 5 gange plasmavolumenet; volumenerne (middel ± SD) var henholdsvis 370 ± 184 ml/kg, 398 ± 92 ml/kg og 463 ± 116 ml/kg for doser på 0,3; 1,0 og 3,0 mg/kg/dag.