FrancophonIA/ELRC3.0 huggingface dataset:
English: Gender and race
Danish: Køn og race
English: This causes the symptoms of the illness.
Danish: Dette forårsager symptomerne på sygdommen.
English: See section 4.
Danish: Se pkt 4.
English: Primary mNIS+7b
Danish: Primær mNIS+7b
English: • Requirements for home infusion, including availability and timely administration of the appropriate premedication;
Danish: • krav til hjemmeinfusion, herunder tilgængelighed og rettidig administration af passende præmedikation,
English: The infusion site should be monitored for possible infiltration during administration.
Danish: Infusionsstedet skal overvåges for mulig infiltration under administration.
English: 1077 ZX Amsterdam Netherlands
Danish: 1077 ZX Amsterdam Nederlandene
English: • Amyloid can build up around the nerves, heart, and other places in the body, preventing them from working normally.
Danish: • Amyloid kan ophobe sig omkring nerverne, hjertet og andre steder i kroppen og forhindrer dem i at fungere normalt.
English: Improvement was observed at 9 months, the first post-baseline assessment in the study.
Danish: Forbedring blev observeret efter 9 måneder, den første vurdering efter baseline i studiet.
English: The frequency of the adverse reactions is expressed according to the following categories:
Danish: Hyppigheden af bivirkninger udtrykkes i henhold til de følgende kategorier:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1320/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1320/001
English: No formal clinical drug interaction studies have been performed.
Danish: Der er ikke udført formelle interaktionsstudier.
English: These signs are listed at the beginning of section 4.
Danish: Disse tegn er angivet i begyndelsen af pkt.
English: Infusion-related reactions Infusion-related reactions are very common (may affect more than 1 in 10 people).
Danish: Infusionsrelaterede reaktioner Infusionsrelaterede reaktioner er meget almindelige (kan påvirke flere end 1 ud af 10 patienter).
English: aAll endpoints analysed using the mixed-effect model repeated measures (MMRM) method.
Danish: aAlle endepunkter analyseret ved brug af mixed-effect model repeated measures (MMRM) -metoden.
English: Table 2: Clinical Efficacy Results from the Placebo-Controlled Study
Danish: Tabel 2: Resultater for klinisk effekt fra det placebokontrollerede studie
English: No data are available for patients weighing ≥ 110 kg.
Danish: Der foreligger ingen data for patienter, som vejer ≥ 110 kg.
English: • Steps to consider to prevent further IRRs;
Danish: • trin, der skal overvejes for at forhindre yderligere IRR'er,
English: Extravasation was observed in < 0.5% of infusions in clinical studies.
Danish: Extravasation blev set ved < 0,5 % af infusioner i kliniske studier.
English: Children and adolescents Onpattro is not recommended in children and adolescents under 18 years of age.
Danish: Børn og unge Onpattro anbefales ikke til børn og unge under 18 år.
English: Onpattro is used in adults only.
Danish: Onpattro må kun bruges til voksne.
English: Symptoms of vitamin A deficiency may include:
Danish: Symptomer på A-vitaminmangel kan omfatte:
English: Infusion of Onpattro at home may be considered for patients who have tolerated at least 3 infusions well in the clinic.
Danish: Infusion af Onpattro i hjemmet kan overvejes for patienter, som har tolereret mindst tre infusioner på klinikken godt.
English: Dosing is based on actual body weight.
Danish: Dosering er baseret på faktisk legemsvægt.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: For patients weighing ≥ 100 kg, the maximum recommended dose is 30 mg.
Danish: For patienter, som vejer ≥ 100 kg, er den maksimale anbefalede dosis 30 mg.
English: • Efavirenz, a medicine used to treat HIV infection and AIDS
Danish: • Efavirenz, som er et lægemiddel der bruges til behandling af hiv-infektion og aids
English: • This means there is less TTR protein in the blood that can form amyloid.
Danish: • Det betyder, at der er mindre TTR protein i blodet, som kan danne amyloid.
English: • It is given as a drip into a vein (‘intravenous infusion') usually over about 80 minutes.
Danish: • Det gives som et drop i en vene (“intravenøs infusion”) som regel over 80 minutter.
English: Less than 1% of patisiran in the administered dose was recovered intact in urine.
Danish: Under 1 % af patisiran i den administrerede dosis blev genfundet i urinen.
English: There are no data on the use of Onpattro in pregnant women.
Danish: Der er ingen data om brugen af Onpattro hos gravide kvinder.
English: When these reactions stop, or get better, your doctor or nurse may decide to start the infusion again.
Danish: Når disse reaktioner stopper eller bliver bedre, kan din læge eller sygeplejerske beslutte at starte infusionen igen.
English: • Very common (≥ 1/10)
Danish: • Meget almindelig (≥1/10)
English: If a dose is missed, Onpattro should be administered as soon as possible.
Danish: Hvis en dosis glemmes, skal Onpattro gives snarest muligt.
English: Suspected extravasation should be managed according to local standard practice for non-vesicants.
Danish: Formodet ekstravasation skal behandles ifølge lokal standardpraksis for ikke-blæretrækkende midler.
English: • How the infusion is given;
Danish: • hvordan infusionen gives,
English: IRRs resulted in permanent discontinuation of Onpattro in < 1% of patients in clinical studies.
Danish: IRR'er resulterede i permanent ophør af Onpattro hos < 1% af patienter i kliniske studier.
English: Your doctor may refer you to an eye specialist for a check-up if it is necessary.
Danish: Lægen kan henvise dig til kontrol hos en øjenlæge, hvis det er nødvendigt.
English: The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class (SOC) by frequency.
Danish: Bivirkninger er angivet som MedDRA foretrukket term under MedDRA systemorganklasse (SOC) efter hyppighed.
English: Benefits relative to placebo were also observed across all mNIS+7 components.
Danish: Fordele i forhold til placebo blev også observeret på tværs af alle mNIS+7 komponenter.
English: INFORMATION IN BRAILLE Onpattro
Danish: INFORMATION I BRAILLESKRIFT Onpattro
English: If such signs are present, vitamin A supplementation should not exceed 2500 IU per day.
Danish: Hvis sådanne tegn er til stede, må tilskud af vitamin A ikke overstige 2.500 IE per dag.
English: Patisiran is metabolized by nucleases to nucleotides of various lengths.
Danish: Patisiran metaboliseres af nucleaser til nukleotider med forskellige længder.
English: Women of child-bearing age
Danish: Kvinder i den fødedygtige alder
English: • This protein is made mostly in the liver and carries vitamin A and other substances around the body.
Danish: • Proteinet fremstilles primært i leveren og bærer vitamin A og andre stoffer rundt i kroppen.
English: The frequency of IRRs decreased over time.
Danish: Hyppigheden af IRR'er aftog over tid.
English: Patients experienced benefit across all TTR mutations and the full range of disease severity studied.
Danish: Patienter oplevede fordele på tværs af alle TTR-mutationer og det fulde spænd af sygdomssværhedsgrader, der blev studeret.
English: Your doctor will tell you how long you need to receive Onpattro.
Danish: Din læge vil fortælle dig, hvor længe du skal have Onpattro.
English: • Signs and symptoms of IRRs;
Danish: • tegn og symptomer på IRR´er,
English: The diluted solution should be administered immediately after preparation.
Danish: Den fortyndede opløsning skal indgives umiddelbart efter forberedelse.
English: Few IRRs led to infusion interruption.
Danish: Få IRR'er resulterede i afbrydelse af infusion.
English: All events were mild or moderate in severity and did not lead to treatment discontinuation.
Danish: Alle hændelser var af let til moderat sværhedsgrad og resulterede ikke i ophør af behandling.
English: Product quality is not impacted by presence of the white to off-white coating.
Danish: Produktets kvalitet påvirkes ikke af tilstedeværelsen af den hvide eller off-white belægning.
English: Approximately 5.5% of DLin-MC3-DMA was recovered after 96 hours as its metabolite (DMBA) in urine.
Danish: Cirka 5,5 % af DLin-MC3-DMA blev genfundet efter 96 timer som dets metabolit (DMBA) i urin.
English: White to off-white, opalescent, homogeneous solution (pH: 6.3 - 7.5).
Danish: Hvid til off-white, opaliserende, homogen opløsning (pH: 6,3-7,5).
English: Approximately 10% of patients had the V30M mutation and early onset of symptoms (< 50 years of age).
Danish: Cirka 10 % af patienterne havde V30M-mutationen og tidlig debut af symptomer (< 50 år).
English: The decision for a patient to receive home infusions should be made after evaluation and recommendation by the treating physician.
Danish: Beslutningen om, hvorvidt en patient kan få infusioner i hjemmet, skal tages efter evaluering og anbefaling af den behandlende læge.
English: Forty-nine percent (49%) and 50% of patients had a New York Heart Association (NYHA) Class of I or II, respectively.
Danish: Hhv. niogfyrre (49 %) og 50 % af patienterne var klassificeret som New York Heart Association (NYHA) Klasse I eller II.
English: Secondary Norfolk QoL-DNb
Danish: Sekundær Norfolk QoL-DNb
English: Home infusions should be performed by a healthcare professional.
Danish: Infusioner i hjemmet skal foretages af sundhedspersonale.
English: It is important to tell your doctor or nurse if you are taking any of the following medicines as your doctor may need to change the dose:
Danish: Det er vigtigt, at du fortæller lægen eller sygeplejersken, hvis du tager et af de følgende lægemidler, da lægen muligvis kan blive nødt til at ændre dosis:
English: Uncommon: may occur in up to 1 in 100 infusions
Danish: Ikke almindelig: kan forekomme ved op til 1 ud af 100 infusioner
English: • Suitability of the patient for home infusion;
Danish: • patientens egnethed til at foretage infusion i hjemmet,
English: Reactions to this infusion may happen during treatment with Onpattro.
Danish: Reaktioner på denne infusion kan forekomme under behandling med Onpattro.
English: Common: may affect up to 1 in 10 people
Danish: Almindelig: kan påvirke op til 1 ud af 10 personer
English: Greater than 95% of patisiran in the circulation is associated with lipid nanoparticles.
Danish: Mere end 95 % af patisiran i kredsløbet er forbundet med lipidnanopartikler.
English: In the unlikely event that you are given too much (an overdose) your doctor or nurse will check you for side effects.
Danish: I det usandsynlige tilfælde, at du får for meget Onpattro (en overdosis), vil lægen eller sygeplejersken kontrollere dig for bivirkninger.
English: In the study, 148 patients received Onpattro and 77 patients received placebo.
Danish: I studiet fik 148 patienter Onpattro, og 77 patienter fik placebo.
English: • Onpattro does not contain preservatives.
Danish: • Onpattro indeholder ikke konserveringsmidler.
English: • Remove Onpattro from the refrigerator.
Danish: • Tag Onpattro ud af køleskabet.
English: • Action to take in the event of an IRRs and in case of emergency;
Danish: • nødvendige foranstaltninger i tilfælde af IRR´er og i nødstilfælde,
English: The educational material for patients (a home infusion guide detailing the steps to undertake during home infusion) should include information about:
Danish: Uddannelsesmaterialet til patienter (en vejledning i hjemmeinfusion, som beskriver de nødvendige trin ved hjemmeinfusion) bør indeholde oplysninger om:
English: This is 0.2% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Det er 0,2 % af det anbefalede maksimale daglige indtag af natrium i kosten for en voksen.
English: • Your doctor will work out how much Onpattro to give you - this will depend on your body weight.
Danish: • Din læge vil beregne, hvor meget Onpattro du skal have, da det vil afhænge af din legemsvægt.
English: Genotoxicity/Carcinogenicity
Danish: Genotoksicitet/Karcinogenicitet
English: Serum TTR reduction was maintained with continued dosing.
Danish: Reduktionen i serum TTR opretholdes med vedvarende dosering.
English: Do not stop treatment with Onpattro unless your doctor tells you to.
Danish: Stop ikke behandling med Onpattro, med mindre din læge instruerer dig derom.
English: There are no data on the effects of Onpattro on human fertility.
Danish: Der er ingen data om virkningen af Onpattro på human fertilitet.
English: Vitamin A testing
Danish: Vitamin A-test
English: These include anti-histamines, a corticosteroid (a medicine that suppresses inflammation), and a pain reliever.
Danish: Disse inkluderer antihistaminer, et kortikosteroid (et lægemiddel, der undertrykker inflammation) og et smertestillende middel.
English: Very common: may affect more than 1 in 10 people • Swelling of the arms or legs (peripheral oedema)
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 personer • Hævelse i arme eller ben (perifert ødem)
English: Do not mix or dilute with other medicinal products.
Danish: Bland eller fortynd ikke indholdet med andre lægemidler.
English: Onpattro did not exhibit a genotoxic potential in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice.
Danish: Onpattro viste ikke genotoksisk potentiale in vitro og in vivo og var ikke karcinogent i transgene rasH2-mus.
English: Pharmacotherapeutic group: Other nervous System Drugs; ATC code: N07XX12.
Danish: Farmakoterapeutisk klassifikation: Andre midler med virkning på nervesystemet, ATC-kode: N07XX12
English: Tell your doctor if you have an unplanned pregnancy.
Danish: Fortæl det til lægen, hvis du har en ikke planlagt graviditet.
English: As patisiran is not pharmacologically active in rabbits, these effects are not due to reductions in TTR, thyroxine or vitamin A.
Danish: Da patisiran ikke er farmakologisk aktivt hos kaniner, skyldes disse virkninger ikke reduktioner i TTR, thyroxin eller vitamin A.
English: (OnpattroPlacebo) Treatment Difference, LS Mean (95% CI)
Danish: (OnpattroPlacebo) Behandlings forskel, LS gennemsnit (95 % KI)
English: This medicinal product is for single-use only.
Danish: Dette lægemiddel er kun til engangsbrug.
English: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, Hrvatska,
Danish: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, Hrvatska, Ireland, Ísland, Κύπρος, Latvija,
English: However, transport and tissue uptake of vitamin A can occur through alternative mechanisms in the absence of retinol binding protein.
Danish: Transport og optagelse af vitamin A i vævet kan dog forekomme via alternative mekanismer ved fravær af retinol-bindende protein.
English: Liver and spleen were the primary target organs of toxicity in both rats and monkeys.
Danish: Lever og milt var de primære målorganer for toksicitet hos både rotter og aber.
English: ADOH B.V., NIJMEGEN Godfried Bomansstraat 31 6543 JA Nijmegen Netherlands
Danish: ADOH B.V., NIJMEGEN Godfried Bomansstraat 31 6543 JA Nijmegen Nederlandene
English: DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine) Cholesterol
Danish: DSPC (1,2-distearoyl-sn-glycero-3-phosphocholin) Kolesterol
English: • Leakage of the drug into the surrounding tissue at the site of infusion, which may cause swelling or redness
Danish: • Lækage af lægemidlet ud i det omgivende væv på infusionsstedet, der kan forårsage hævelse eller rødme
English: • Discard vial if it has been frozen.
Danish: • Bortskaf hætteglasset, hvis det har været nedfrosset.
English: Tell your doctor if you are planning to become pregnant.
Danish: Fortæl det til lægen, hvis du har planer om at blive gravid.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before starting this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, inden du begynder tage dette lægemiddel.
English: If you have problems with your vision or any other eye problems whilst using Onpattro, you should talk to your doctor.
Danish: Hvis du har problemer med synet eller andre øjenproblemer, når du bruger Onpattro, skal du tale med lægen.
English: Prior to the launch of Onpattro in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Danish: Inden Onpattro lanceres i hver medlemsstat, skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om indholdet og formatet af undervisningsmaterialerne, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: In Onpattro-treated patients, the events decreased in frequency over time.
Danish: Hos patienter behandlet med Onpattro aftog hyppigheden af hændelser over tid.
English: Elderly patients No dose adjustment is required in patients ≥ 65 years of age (see section 5.2).
Danish: Ældre patienter Dosisjustering er ikke nødvendig hos patienter ≥ 65 år (se pkt 5.2).
English: • If Onpattro is administered more than 3 days after the missed dose, dosing should be continued every 3 weeks thereafter.
Danish: • Hvis Onpattro gives mere end 3 dage efter den glemte dosis, skal dosering fortsætte hver 3. uge derefter.
English: Due to the potential teratogenic risk arising from unbalanced vitamin A levels, Onpattro should not be used during pregnancy, unless the clinical condition of the woman requires treatment.
Danish: På grund af en mulig teratogen risiko ved ubalancerede niveauer af vitamin A, må Onpattro ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling.
English: You should not use Onpattro if you are pregnant, unless advised by your doctor.
Danish: Du bør ikke bruge Onpattro, hvis du er gravid, medmindre lægen anbefaler det.
English: • if you have ever had a severe allergic reaction to patisiran, or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du nogensinde har haft en allergisk reaktion over for patisiran eller et af de øvrige indholdsstoffer (angivet i pkt.
English: Patient demographics and baseline characteristics were balanced between treatment groups, except that a higher proportion of patients in the Onpattro group had a non-V30M mutation (62% vs. 48%).
Danish: Patientdemografi og karakteristika ved baseline var afbalanceret mellem behandlingsgrupper med undtagelse af, at en højere andel af patienter i Onpattro-gruppen havde en non-V30M-mutation (62 % vs. 48 %).
English: The only adverse reaction resulting in the discontinuation of Onpattro was an infusion-related reaction (0.7%).
Danish: Den eneste bivirkning, som resulterede i seponering af Onpattro, var en infusionsrelateret reaktion (0,7 %).
English: • Body aches or pain, including pain in the back, neck, or joints
Danish: • Ømhed eller smerter i kroppen, herunder smerter i ryg, nakke eller led.
English: IRRs have been observed in patients treated with Onpattro.
Danish: IRR'er er blevet observeret hos patienter behandlet med Onpattro.
English: Chemical and physical in-use stability has been demonstrated for 16 hours at room temperature (up to 30°C).
Danish: Kemisk og fysisk stabilitet efter anbrud er påvist til 16 timer ved stuetemperatur (op til 30 °C).
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and given symptomatic treatment, as appropriate.
Danish: I tilfælde af overdosering, anbefales det at patienten overvåges for eventuelle tegn eller symptomer på bivirkninger og behandles symptomatisk derefter som relevant.
English: Your doctor will tell you whether your condition allows you to drive vehicles and use machines safely.
Danish: Din læge vil fortælle dig, om du sikkert kan føre motorkøretøj og betjene maskiner i din tilstand.
English: For premedications not available or not tolerated intravenously, equivalents may be administered orally.
Danish: For præmedikamenter, som ikke er tilgængelige eller ikke tolereres intravenøst kan ækvivalenter gives oralt.
English: Table 1: Adverse reactions reported for Onpattro 300 micrograms per kg System Organ Class
Danish: Tabel 1: Bivirkninger rapporteret for Onpattro 300 mikrogram per kg Systemorganklasse
English: If you do not have problems with your infusions in the clinic, your doctor may talk with you about a healthcare professional giving you your infusions at home.
Danish: Hvis du tolererer dine infusioner på klinikken godt, vil lægen muligvis tale med dig om, at sundhedspersonale kan give dig dine infusioner derhjemme.
English: The net effect on CYP2B6 substrates (e.g., bupropion and efavirenz) in vivo is unknown.
Danish: Den endelige virkning af substrater af CYP2B6 (fx bupropion og efavirenz) in vivo er ukendt.
English: Each mL of concentrate contains 3.99 mg sodium.
Danish: Hver ml koncentrat indeholder 3,99 mg natrium.
English: It is unknown whether Onpattro is excreted in human milk.
Danish: Det vides ikke, om Onpattro udskilles i human mælk.
English: • If Onpattro is administered within 3 days of the missed dose, dosing should be continued according to the patient's original schedule.
Danish: • Hvis Onpattro gives inden for 3 dage af den glemte dosis, skal dosering fortsætte i henhold til patientens oprindelige doseringsplan.
English: A statistically significant benefit in mNIS+7 with Onpattro relative to placebo was observed at 18 months (Table 2).
Danish: En statistisk signifikant fordel ved mNIS+7 med Onpattro i forhold til placebo blev observeret efter 18 måneder (Tabel 2).
English: Patients treated with Onpattro experienced statistically significant benefits in all secondary endpoints compared to patients who received placebo (all p <0.001) (Table 2).
Danish: Patienter, som blev behandlet med Onpattro, oplevede statistisk signifikante fordele i alle sekundære endepunkter sammenlignet med patienter, som fik placebo (alle p < 0,001) (Tabel 2).
English: Missed dose
Danish: Glemt dosis
English: Luxembourg/Luxemburg, Magyarország, Malta, Norge, Polska, România, Slovenija, Slovenská republika, Suomi/Finland Alnylam Netherlands B.V.
Danish: Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Norge, Polska, România, Slovenija, Slovenská republika, Suomi/Finland
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Danish: Andre bivirkninger Fortæl lægen eller sygeplejersken, hvis du oplever nogen af følgende bivirkninger:
English: Required premedication
Danish: Påkrævet præmedikation
English: • Onpattro will be given to you by a doctor or nurse.
Danish: • Du vil få Onpattro af en læge eller sygeplejerske.
English: The Onpattro infusion should be discontinued in the case of a serious or life-threatening IRR.
Danish: Infusionen med Onpattro skal seponeres i tilfælde af en alvorlig eller livstruende IRR.
English: Pregnancy should be excluded before starting treatment with Onpattro.
Danish: Graviditet skal udelukkes, inden behandlingen med Onpattro påbegyndes.
English: Intravenous administration of Onpattro had no effect on male reproductive assessments in sexually mature cynomolgus monkeys.
Danish: Intravenøs administration af Onpattro havde ingen effekt på reproduktionsvurderinger hos kønsmodne cynomolgus-hanaber.
English: Talk to your doctor or nurse about suitable methods of contraception.
Danish: Tal med lægen eller sygeplejersken om egnede præventionsmetoder.
English: Patisiran is not a substrate of cytochrome P450 enzymes.
Danish: Patisiran er ikke et substrat af cytokrom P450-enzymer.
English: Your doctor will ensure that your vitamin A levels have returned to normal before you try to become pregnant.
Danish: Lægen vil sikre, at dine niveauer af vitamin A er blevet normale igen, før du prøver at blive gravid.