FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Macimorelin Aeterna Zentaris and what is it used for?
Danish: Hvad er Macimorelin Aeterna Zentaris, og hvad anvendes det til?
English: Other information about Macimorelin Aeterna Zentaris
Danish: Andre oplysninger om Macimorelin Aeterna Zentaris
English: Why is Macimorelin Aeterna Zentaris authorised in the EU?
Danish: Hvorfor blev Macimorelin Aeterna Zentaris godkendt i EU?
English: Macimorelin Aeterna Zentaris gave a similar number of negative test results for growth hormone deficiency as a comparator test; however, it gives fewer positive test results than the comparator.
Danish: Macimorelin Aeterna Zentaris gav et lignende antal negative testresultater for væksthormonmangel som en sammenligningstest.
English: What are the risks associated with Macimorelin Aeterna Zentaris?
Danish: Hvilke risici er der forbundet med Macimorelin Aeterna Zentaris?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Macimorelin Aeterna Zentaris have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Macimorelin Aeterna Zentaris.
English: How is Macimorelin Aeterna Zentaris used?
Danish: Hvordan anvendes Macimorelin Aeterna Zentaris?
English: What benefits of Macimorelin Aeterna Zentaris have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Macimorelin Aeterna Zentaris?
English: How does Macimorelin Aeterna Zentaris work?
Danish: Hvordan virker Macimorelin Aeterna Zentaris?
English: Macimorelin Aeterna Zentaris received a marketing authorisation valid throughout the EU on 11 January 2019.
Danish: Macimorelin Aeterna Zentaris (macimorelin) EMA/820056/2018
English: At the final analysis, 1,653 deaths were reported.
Danish: Ved den endelige analyse var der indberettet 1.653 dødsfald.
English: There may be local guidelines for disposal.
Danish: Der findes muligvis lokale retningslinjer for bortskaffelse.
English: This may vary depending on whether you are an adult or a child.
Danish: Dette kan variere afhængigt af, om De er voksen eller barn.
English: Poorly controlled hypertension.
Danish: Dårligt kontrolleret hypertension.
English: • Serious allergic reactions which may include:
Danish: • Alvorlige allergiske reaktioner, som kan omfatte:
English: Your injection could take about 15 seconds.
Danish: Injektionen tager omkring 15 sekunder.
English: The healthcare professional's educational material should contain the following key elements:
Danish: Sundhedspersonalets undervisningsmateriale skal indeholde følgende centrale elementer:
English: Treatment with Aranesp is divided into two stages, correction and maintenance phase.
Danish: Behandling med Aranesp er delt i to trin, korrigerings- og vedligeholdelsesfase.
English: study (study 20010184).
Danish: TREAT-studiet (studie 20010184).
English: Bioavailability is 37% with subcutaneous administration.
Danish: Biotilgængeligheden er 37 % ved subkutan administration.
English: No alteration of fertility was detected.
Danish: Der er ikke påvist nogen ændring i fertilitet.
English: In some cases, your doctor may recommend that you take iron supplements.
Danish: I nogle tilfælde vil Deres læge anbefale, at De tager et jerntilskud.
English: Please discuss this with your doctor.
Danish: Du bedes tale med din læge om dette.
English: Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect.
Danish: Fordi det vil tage Deres krop lidt tid at producere røde blodlegemer vil det vare omkring fire uger før De vil mærke nogen effekt.
English: Step 1: Prepare
Danish: Trin 1: Forbered
English: Your healthcare professional should always record the exact product you are using.
Danish: Deres læge bør altid registrere nøjagtig det produkt, De bruger.
English: Equipment:
Danish: Udstyr:
English: This will make the injection more comfortable.
Danish: Dette vil gøre injektionen mere behagelig.
English: 30 minutes
Danish: 30 minutter
English: • Allergic reactions
Danish: • Allergiske reaktioner
English: 15 seconds
Danish: 15 sekunder
English: Placental transfer was minimal.
Danish: Transporten over placenta var minimal.
English: The injections will be given by a healthcare professional.
Danish: Injektionerne vil blive givet af en uddannet sundhedsmedarbejder.
English: More severe cases have been observed with long-acting epoetins.
Danish: Der er observeret mere alvorlige tilfælde i forbindelse med langtidsvirkende epoetiner.
English: Do not administer more than one dose.
Danish: Der må ikke administreres mere end én dosis.
English: J Keep pushing down on your skin.
Danish: J Bliv ved med at trykke ned på huden.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Danish: Som ved alle vækstfaktorer, er der frygt for at epoetiner kan stimulere væksten af tumorceller.
English: Food and drink do not affect Aranesp.
Danish: Mad og drikkevarer påvirker ikke virkningen af Aranesp.
English: Using Aranesp with food and drink
Danish: Brug af Aranesp sammen med mad og drikke
English: Talk with your healthcare provider about proper disposal.
Danish: Tal med sundhedspersonalet om korrekt bortskaffelse.
English: In clinical studies, minimal accumulation was observed with either route of administration.
Danish: I kliniske studier blev der observeret minimal akkumulation for begge administrationsveje.
English: Correction phase:
Danish: Korrektionsfase:
English: ESAs are not indicated for use in this patient population.
Danish: ESA'er er ikke indiceret til brug i denne patientpopulation.
English: Maintenance phase:
Danish: Vedligeholdelsesfase:
English: Important: Do not touch the red start button yet.
Danish: Vigtigt: Undlad at røre ved den røde startknap endnu.
English: In preclinical studies it has been shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum half-life.
Danish: I prækliniske studier er det vist, at den renale clearance er minimal (op til 2 % af den totale clearance) og ikke påvirker serum halveringstiden.
English: - If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Danish: - Hvis du er cancerpatient, skal du være opmærksom på, at Aranesp kan fungere som blodcellevækstfaktor og at det under visse omstændigheder kan have en negativ virkning på din cancer.
English: Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood.
Danish: Ciclosporin og tacrolimus (lægemidler, der undertrykker immunsystemet) kan påvirkes af antallet af røde blodlegemer i Deres blod.
English: Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
Danish: Vigtigt: Hvis De fjerner den fyldte pen, og vinduet ikke er gult, eller det ser ud som om lægemidlet stadig injiceres, har De ikke modtaget en fuld dosis.
English: In the absence of incompatibility studies, this medicinal product must not be mixed or administered as an infusion with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes eller administreres som en infusion sammen med andre lægemidler.
English: In the Aranesp group, 83% were receiving dialysis and 17% were not receiving dialysis.
Danish: I Aranesp-gruppen var 83 % i dialyse, og 17 % var ikke i dialyse.
English: There are no adequate and well-controlled studies with Aranesp in pregnant women.
Danish: Der foreligger ikke tilstrækkelige, velkontrollerede studier med Aranesp til gravide kvinder.
English: Aranesp has not been tested in pregnant women.
Danish: Aranesp er ikke blevet testet på gravide kvinder.
English: - Take special care with other products that stimulate red blood cell production: Aranesp is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Danish: - Vær særlig forsigtig med andre produkter, der stimulerer produktionen af røde blodlegemer: Aranesp er ét produkt blandt en gruppe produkter, der stimulerer produktionen af røde blodlegemer, som det humane protein erytropoietin gør.
English: If someone else is injecting for you, they can also use the back of your arms.
Danish: Hvis en anden person foretager injektionen, kan bagsiden af armene også bruges.
English: If it is cloudy or there are particles in it, you must not use it.
Danish: Hvis den er uklar eller der er partikler i, må De ikke bruge den.
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Danish: Find et behageligt, godt oplyst og rent sted, og læg al det udstyr, De skal bruge i Deres nærhed.
English: Because of individual variability, titration to optimal therapeutic doses is expected for individual patients.
Danish: På grund af individuel variation forventes titrering til optimal terapeutisk dosis for enkelte patienter.
English: The primary efficacy endpoint [change in haemoglobin between baseline and the evaluation period (week 21-28)] was comparable between the two groups.
Danish: Det primære endepunkt for effekt [ændringen i hæmoglobin fra baseline til evalueringsperioden (uge 21-28)] var sammenligneligt de to grupper imellem.
English: • plan to get pregnant.
Danish: • planlægger at blive gravid.
English: Yellow window (injection complete)
Danish: Gult vindue (injektion fuldført)
English: The clinical results obtained so far do not indicate any interaction of darbepoetin alfa with other substances.
Danish: De kliniske resultater opnået til nu indikerer ingen interaktion mellem darbepoetin alfa og andre stoffer.
English: Do not use Aranesp: - if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Aranesp - hvis De er allergisk over for darbepoetin alfa eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: This may be associated with life-threatening complications of the cardiovascular system.
Danish: Dette kan ydermere medføre livstruende komplikationer fra det kardiovaskulære system.
English: Aranesp is a sterile but unpreserved product.
Danish: Aranesp er et sterilt, men ukonserveret produkt.
English: The maximum amount of Aranesp that can be safely administered in single or multiple doses has not been determined.
Danish: Den maksimale mængde Aranesp, som kan indgives forsvarligt i enkelte eller multiple doser, er ikke fastlagt.
English: Do not use Aranesp if you think it has been frozen.
Danish: Brug ikke Aranesp, hvis De tror, at den har været frosset.
English: Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Danish: Bemærk: Når De har fjernet den fyldte pen fra huden, dækkes nålen automatisk.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. at det er stort set ‘natriumfrit'.
English: If you want to stop using Aranesp, you should discuss it with your doctor first.
Danish: Hvis De ønsker at holde op med at bruge Aranesp, skal De først drøfte det med Deres læge.
English: Check that it is the correct dose that your doctor has prescribed.
Danish: Kontroller, at det er den korrekte dosis, den som Deres læge har ordineret.
English: Important: Needle is inside
Danish: Vigtigt: Nålen sidder indeni
English: Before administration the Aranesp solution should be inspected for visible particles.
Danish: Før administration skal Aranesp opløsningen undersøges for synlige partikler.
English: 2 Frequency cannot be estimated from the available data.
Danish: 2 Hyppigheden kan ikke estimeres ud fra forhåndenværende data.
English: The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Danish: Darbepoetin alfas carcinogene potentiale er endnu ikke blevet evalueret ved langtids dyrestudier.
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Aranesp, treatment with Aranesp must not be restarted in this patient at any time.
Danish: Hvis patienten har udviklet en alvorlig kutan reaktion såsom SJS eller TEN, der skyldes anvendelse af Aranesp, må behandling med Aranesp ikke reinitieres hos denne patient på noget tidspunkt.
English: A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Danish: Der er også foretaget en systematisk gennemgang af flere end 9.000 cancerpatienter, som deltog i 57 kliniske forsøg.
English: • think you may be pregnant; or
Danish: • tror De er gravid eller
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Danish: Erytropoietin-receptorer kan være udtrykt i overfladen på en række forskellige tumorceller.
English: PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
Danish: PRCA betyder, at kroppen har standset eller reduceret produktionen af røde blodlegemer, hvilket medfører alvorlig anæmi.
English: If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective.
Danish: Hvis patientens kliniske respons (udmattethed og hæmoglobinrespons) er utilstrækkelig efter ni uger, vil yderligere behandling muligvis ikke være effektiv.
English: Do not touch the cleaned area of the skin
Danish: Rør ikke ved det afrensede område af huden
English: Window turns yellow when the injection is done
Danish: Vinduet bliver gult, når injektionen er færdig
English: Data are presented separately for CRF and cancer patients reflecting the different adverse reaction profile in these populations.
Danish: Data vises separat for CRF- og cancerpatienter, så det afspejler den forskellige bivirkningsprofil i disse populationer.
English: The target haemoglobin concentration in two studies was > 13 g/dL; in the remaining three studies it was 12-14 g/dL.
Danish: Målkoncentrationen af hæmoglobin i to af studierne var > 13 g/dl, og i de øvrige tre studier var den 12-14 g/dl.
English: - if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor.
Danish: - hvis De har fået stillet diagnosen forhøjet blodtryk, og blodtrykket ikke kan kontrolleres med anden medicin, der er ordineret af Deres læge.
English: • Choose a different site each time you give yourself an injection.
Danish: • Vælg et nyt sted, hver gang De giver Dem selv en injektion.
English: The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection.
Danish: Ubehaget på injektionsstedet var generelt let og forbigående og opstod fortrinsvis efter den første injektion.
English: If clinically indicated, phlebotomy may be performed.
Danish: Hvis klinisk indiceret kan flebotomi udføres.
English: In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Danish: I lyset af ovenstående bør blodtranfusion i nogle kliniske situationer være den foretrukne behandling af anæmi hos patienter med cancer.
English: • High blood pressure (hypertension)
Danish: • Forhøjet blodtryk (hypertension)
English: The rashes may progress to widespread peeling of the skin and life-threatening complications.
Danish: Udslættet kan udvikle sig til omfattende afskalning af hud og livstruende komplikationer.
English: There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
Danish: Der var en forventet moderat (< 2 gange) forøgning af serumkoncentrationen, når man nærmede sig steady state, men ingen uventet akkumulering ved gentagen indgift.
English: Contact your healthcare provider immediately.
Danish: Kontakt straks sundhedspersonalet.
English: The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Danish: Beslutningen om at administrere rekombinante erythropoietiner bør være baseret på en vurdering af fordele versus risici med den enkelte patients deltagelse og under hensyntagen til den specifikke kliniske sammenhæng.
English: • A demonstration device
Danish: • En demonstrationsanordning
English: Important: Follow your healthcare provider's instructions about selecting sites for injection appropriate to you and about changing the site for each injection.
Danish: Vigtigt: Følg sundhedspersonalets anvisninger om valg af injektionssteder, der passer til dig, samt om at vælge et nyt sted til hver injektion.
English: B Inspect the pre-filled pen.
Danish: B Inspicér den fyldte pen.
English: Not known: frequency cannot be estimated from available data • Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy)
Danish: Ikke kendt: kan ikke vurderes ud fra forhåndenværende data • Pure red cell aplasi (PRCA) - (anæmi, unormal træthed, mangel på energi)
English: It is unknown whether Aranesp is excreted in human milk.
Danish: Det er ukendt, om Aranesp udskilles i human mælk.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Danish: Der er indberettet tilfælde hos patienter med hepatitis C i behandling med interferon og ribavirin, når epoetiner anvendes samtidig.
English: The carton contains a package leaflet with the full instructions for use and handling.
Danish: Pakken indeholder en indlægsseddel med udførlige anvisninger vedrørende brug og håndtering.
English: If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.
Danish: Hvis De oplever disse symptomer, skal De kontakte din læge, som vil finde det bedste handlingsforløb til behandling af Deres anæmi.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Danish: I de fire placebokontrollerede studier lå hazard ratioen for den samlede overlevelse på mellem 1,25 og 2,47 i kontrolgruppens favør.
English: Incidence of adverse reactions are listed below by system organ class and frequency.
Danish: Forekomsten af bivirkninger er angivet nedenfor, inddelt efter systemorganklasse og hyppighed.
English: If it occurs, appropriate dose adjustment should be made as provided.
Danish: Hvis det skulle forekomme, skal dosis justeres som angivet.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.
English: Remember: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Danish: Husk: Hvis De har problemer, så vær ikke tilbageholdende med at spørge Deres læge eller sygeplejerske om hjælp og råd.
English: Do not try to inject yourself if you have not been trained.
Danish: Forsøg ikke at injicere Dem selv, hvis De ikke er blevet instrueret i det.
English: Dialysis vascular access thrombosisd
Danish: Dialyserelateret vascular access thrombosisd
English: “click”
Danish: “KLIK”
English: Misuse of Aranesp by healthy persons may lead to an excessive increase in packed cell volume.
Danish: Anvendes Aranesp ukorrekt af raske mennesker, kan dette medføre en al for stor øgning af pakket cellevolumen.
English: I When you are ready to inject, pressthe red start button.
Danish: I Når De er klar til at injicere, skal De trykkepå den røde startknap.
English: Before you inject Aranesp you must do the following:
Danish: Før De indsprøjter Aranesp, skal De gøre følgende:
English: In controlled clinical studies, use of Aranesp and other ESAs have shown:
Danish: I kontrollerede kliniske studier har brugen af Aranesp og andre ESA'er givet følgende resultater:
English: It is important to tell your doctor if you are taking either of these medicines.
Danish: Det er derfor vigtigt, at De fortæller lægen, hvis De får nogle af disse lægemidler.
English: Aranesp works in exactly the same way as the natural hormone erythropoietin.
Danish: Aranesp virker på nøjagtig samme måde som det naturligt forekommende hormon erythropoietin.
English: Important: It is important to keep your skin stretched or pinched while injecting.
Danish: Vigtigt: Det er vigtigt, at De holder huden strakt eller sammenknebet, mens De injicerer.
English: Blood pressure should be monitored in all patients, particularly during initiation of Aranesp therapy.
Danish: Blodtrykket bør overvåges hos alle patienter, især når behandlingen med Aranesp iværksættes.
English: In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary.
Danish: For at sikre effektiv erytropoiese bør jernstatus evalueres hos alle patienter før og under behandling.
English: Data presented from controlled studies included 1,357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.
Danish: Data præsenteret fra kontrollerede studier inkluderede 1.357 patienter, hvoraf 766 fik Aranesp og 591 patienter fik r-HuEPO.
English: Darbepoetin alfa did not reveal any genotoxic potential nor did it have any effect on the proliferation of non-haematological cells in vitro or in vivo.
Danish: Darbepoetin alfa vist ikke noget genotoksisk potentiale, og ej heller havde det nogen effekt på celledelingen af ikke-hæmatologiske celler hverken in vitro eller in vivo.
English: You may change the injection site if you notice the area is red or sore.
Danish: De skal vælge et andet injektionssted, hvis De bemærker, at det valgt område er rødt eller ømt.
English: In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
Danish: I denne studie var den gennemsnitlige (SD) terminale halveringstid 74 (SD 27) timer.
English: However, there is potential for an interaction with substances that are highly bound to red blood cells e.g. cyclosporin, tacrolimus.
Danish: Der er risiko for interaktion med stoffer som er kraftigt bundet til røde blodlegemer, f.eks. ciclosporin og tacrolimus.
English: In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:
Danish: For at kontrollere Deres anæmi vil initialdosis af Aranesp pr. kilogram legemsvægt være enten:
English: Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed.
Danish: Der blev ligeledes fundet en reduktion i træthed, målt ved hjælp af ”Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue)” skala.
English: In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
Danish: I de kroniske toksicitets studier observeredes hverken tumorogene eller uventede mitogene respons i nogen vævstyper.
English: Step 4: Finish L Dispose of the used pre-filled pen and grey cap.
Danish: Trin 4: Afslut L Bortskaf den brugte fyldte pen og den grå hætte.