FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Onpattro, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: En beslutning om, hvorvidt amningen skal afbrydes, eller behandlingen med Onpattro skal seponeres/undlades, skal tages efter afvejning af barnets fordele ved amning og behandlingens fordele for moderen.
English: The infusion may need to be slowed down or stopped, and you may need to take other medicines to manage the reaction.
Danish: Det er muligt, at infusionen skal stoppes eller hastigheden sænkes, eller at du skal tage andre lægemidler til at behandle reaktionen.
English: Patients receiving Onpattro experienced similar benefits relative to placebo in mNIS+7 and Norfolk QoL-DN score across all subgroups including age, sex, race, region, NIS score, V30M mutation status, prior tafamidis meglumine or diflunisal use, disease stage, and patients with pre-defined cardiac involvement.
Danish: Patienter, som fik Onpattro, oplevede tilsvarende fordele i forhold til placebo i mNIS+7 og Norfolk QoL-DN score på tværs af alle undergrupper, herunder alder, køn, race, region, NIS-score, V30M-mutationsstatus, tidligere anvendelse af tafamidismeglumin eller diflunisal, sygdomsstadie og patienter med af hjertet.
English: Your doctor will measure your vitamin A levels, and if they are too low they should have returned to normal and any symptoms due to vitamin A deficiency should have resolved before you start treatment with Onpattro.
Danish: Din læge vil måle dine niveauer af vitamin A, og hvis de er for lave, skal de være vendt tilbage til det normale, og eventuelle symptomer, der skyldes mangel på vitamin A, skal være forsvundet, før du starter behandling med Onpattro.
English: The educational material for HCPs should include information about:
Danish: Uddannelsesmaterialet til sundhedspersonale bør indeholde oplysninger om:
English: If a woman intends to become pregnant, Onpattro and vitamin A supplementation should be discontinued and serum vitamin A levels should be monitored and have returned to normal before conception is attempted.
Danish: Hvis en kvinde ønsker at blive gravid, skal Onpattro og tilskud af vitamin A seponeres, og serumniveauerne af vitamin A skal monitoreres og være vendt tilbage til normal, før undfangelse forsøges.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier har ikke været tilstrækkelige med hensyn til reproduktionstoksicitet (se pkt.
English: At the dose regimen of 300 micrograms per kg every 3 weeks, steady state was reached by 24 weeks of treatment.
Danish: Ved doseringsregimet på 300 mikrogram per kg hver 3. uge, blev steady-state nået efter 24 ugers behandling.
English: Change from Baseline at 18 months, LS Mean (SEM)
Danish: Ændring fra baseline efter 18 måneder, LS
English: • Common (≥ 1/100 to < 1/10) • Uncommon (≥ 1/1,000 to < 1/100)
Danish: • Ikke almindelig (≥1/1.000 til <1/100)
English: In clinical studies, all patients received premedication with a corticosteroid, paracetamol, and H1 and H2 blockers to reduce the risk of IRRs.
Danish: I kliniske studier fik alle patienter præmedikation med et kortikosteroid, paracetamol, og H1- og H2-blokkere for at reducere risikoen for IRR'er.
English: • Irritation or infection of the airways (sinusitis, bronchitis)
Danish: • Luftvejsirritation eller -infektion (sinuitis, bronkitis)
English: • Onpattro is supplied in cartons containing one vial each.
Danish: • Onpattro leveres i kartoner med et hætteglas i hver.
English: • Bupropion, a medicine used to treat depression or to help you to stop smoking
Danish: • Bupropion, som er et lægemiddel der bruges til behandling af depression eller ved rygestop
English: Onpattro is not expected to be affected by inhibitors or inducers of cytochrome P450 enzymes or to cause drug-drug interactions, except for induction and time-dependent inhibition of CYP2B6 in vitro.
Danish: Onpattro forventes ikke at være påvirket af hæmmere eller induktorer af cytokrom P450-enzymer eller at forårsage lægemiddelinteraktioner, undtagen induktion og tidsafhængig hæmning af CYP2B6 in vitro.
English: In the placebo-controlled and open-label clinical studies, 7 of 194 (3.6%) patients with hATTR amyloidosis developed anti-drug antibodies during treatment with Onpattro.
Danish: I de placebokontrollerede og ublindede kliniske studier udviklede 7 ud af 194 (3,6 %) patienter med hATTR amyloidose antistoffer mod lægemidlet under behandling med Onpattro.
English: Onpattro is for intravenous use.
Danish: Onpattro er beregnet til intravenøs anvendelse.
English: Onpattro is a medicine that treats an illness which runs in families called hereditary ATTR (hATTR) amyloidosis.
Danish: Onpattro er et lægemiddel, som behandler en arvelig sygdom kaldet hereditær ATTR (hATTR) amyloidose.
English: Increasing the dose of patisiran resulted in greater TTR reduction, with maximal reductions plateauing at patisiran exposures obtained with 300 micrograms per kg every 3 weeks dosing.
Danish: Øgning af patisirandosis resulterede i større reduktion i TTR, idet maksimale reduktioner nåede et plateau ved eksponering for patisiran på 300 mikrogram per kg med dosering hver 3. uge.
English: • Withdraw the required volume of filtered Onpattro from the sterile container using a sterile syringe.
Danish: • Træk det påkrævede volumen af filtreret Onpattro op fra den sterile beholder med en steril injektionssprøjte.
English: If not used immediately, store the diluted solution in the infusion bag at room temperature (up to 30°C) or at 2°C to 8°C for up to 16 hours (including infusion time).
Danish: Hvis den ikke skal anvendes med det samme, opbevares den fortyndede opløsning i infusionsposen ved stuetemperatur (i op til 30 °C) eller ved 2 °C til 8 °C i op til 16 timer (inklusive infusionstid).
English: At baseline, 46% of patients had stage 1 disease (unimpaired ambulation; mostly mild sensory, motor and autonomic neuropathy in the lower limbs), and 53% had stage 2 disease (assistance with ambulation required; mostly moderate impairment progression to the lower limbs, upper limbs, and trunk).
Danish: Ved baseline havde 46 % af patienterne stadie 1 sygdom (upåvirket gangfunktion; hovedsaglig let sensorisk, motorisk og autonom neuropati i underekstremiteterne), og 53 % havde stadie 2 sygdom (behøver hjælp til at gå; hovedsaglig moderat progredierende svækkelse af underekstremiteter, overekstremiteter og overkrop).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 16 hours at either 2°C to 8°C or room temperature (up to 30°C), including infusion time.
Danish: Hvis det ikke bruges med det samme, er opbevaringstid og -forhold efter anbrud brugerens ansvar og skal højst være 16 timer ved enten 2 °C til 8 °C eller stuetemperatur (op til 30 °C), inklusive infusionstid.
English: Mean reductions in serum retinol binding protein of 45% and serum vitamin A of 62% were observed over 18 months (see sections 4.4 and 4.5).
Danish: Gennemsnitlige reduktioner i retinol-bindende protein i serum på 45 % og vitamin A i serum på 62 % blev observeret over 18 måneder (se pkt.
English: • Onpattro must be diluted prior to intravenous infusion (see instructions in section 6.6).
Danish: • Onpattro skal fortyndes inden intravenøs infusion (se instruktioner i pkt.
English: In the event of an unplanned pregnancy, Onpattro should be discontinued (see section 4.6).
Danish: I tilfælde af ikke-planlagt graviditet skal Onpattro seponeres (se pkt.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V. 4.9 Overdosering
English: At 18 months, a benefit with Onpattro to placebo was observed across all domains of Norfolk QoL-DN, and 51.4% of Onpattro-treated patients experienced an improvement in quality of life (Norfolk QoL-DN change from baseline of < 0 points) compared to 10.4% of placebo-treated patients.
Danish: Efter 18 måneder blev der observeret en fordel med Onpattro i forhold til placebo på tværs af alle domæner af Norfolk QoL-DN, og 51,4 % af patienter behandlet med Onpattro oplevede en forbedring i livskvalitet (Norfolk QoL-DN ændring fra baseline på <0 point) sammenlignet med 10,4 % af patienter behandlet med placebo.
English: There is little to no metabolism of PEG2000-C-DMG.
Danish: Der er begrænset eller ingen metabolisering af PEG2000-C-DMG.
English: To reduce the risk of IRRs, patients should receive premedications on the day of Onpattro infusion, at least 60 minutes prior to the start of infusion (see section 4.2).
Danish: For at reducere risikonen for IRR'er, bør patienter få præmedikamenter på dagen for infusion af Onpattro mindst 60 minutter inden start af infusion (se pkt.
English: • Reddening of the face or body (flushing), warm skin, or rash
Danish: • Rødme i ansigtet eller på kroppen (blussen), varm hud eller udslæt
English: What Onpattro contains
Danish: Onpattro indeholder
English: Onpattro is believed to have no or negligible influence on the ability to drive or use machines.
Danish: Onpattro menes ikke eller kun i ubetydelig grad at påvirke din evne til at føre motorkøretøjr eller betjene maskiner.
English: If you miss an appointment to have Onpattro, ask your doctor or nurse when to book your next treatment.
Danish: Hvis du ikke kommer til et besøg/en aftale, hvor du skal gives Onpattro, skal du spørge din læge eller sygeplejerske, hvornår du skal aftale en tid til din næste behandling.
English: • Swelling of the face
Danish: • Hævelse i ansigtet
English: The European Medicines Agency has waived the obligation to submit the results of studies with Onpattro in all subsets of the paediatric population in hATTR amyloidosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Onpattro i alle undergrupper af den pædiatriske population med hATTR amyloidose (se pkt.
English: Intravenous administration of Onpattro led to increases in serum liver markers (ALT, AST, ALP, and/or total bilirubin) and histopathology findings in the liver (hepatocellular/single cell necrosis, inflammation, pigment deposition, and/or monocytic infiltration) at doses > 100 micrograms per kg every 4 weeks and > 1.0 mg/kg every 3 weeks in rats and monkeys, respectively.
Danish: Intravenøs administration af Onpattro resulterede i stigninger i levermarkører i serum (ALAT, ASAT, ALP, og/eller total bilirubin) og histopatologiske fund i leveren (hepatocellulær/encellet nekrose, inflammation, pigmentaflejringer, og/eller monocytinfiltration) ved doser > 100 mikrogram per kg hver 4. uge og > 1,0 mg/kg hver 3. uge hos hhv. rotter og aber.
English: • Calculate the required volume of Onpattro based on the recommended weight-based dosage (see section 4.2).
Danish: • Beregn det påkrævede volumen af Onpattro ud fra den anbefalede vægtbaserede dosis (se pkt.
English: • Inspect visually for particulate matter and discolouration.
Danish: • Efterse produktet for partikler og misfarvning.
English: Onpattro contains sodium
Danish: Onpattro indeholder natrium
English: Additional or higher doses of one or more of the premedications may be administered to reduce the risk of IRRs, if needed.
Danish: Flere eller højere doser af en eller flere præmedikamenter kan gives for at reducere risikoen for IRR'er, hvis det er nødvendigt.
English: METHOD OF ADMINISTRATION Do not shake or vortex.
Danish: ADMINISTRATIONSMETODE Undlad at ryste eller hvirvle.
English: Exposure to patisiran and the lipid components (DLin-MC3-DMA and PEG2000-C-DMG) increased proportionally with increase in dose over the range evaluated in clinical studies (10 to 500 micrograms per kg).
Danish: Eksponering for patisiran og lipidkomponenterne (DLin-MC3-DMA og PEG2000-C-DMG) steg proportionalt med dosisstigning over hele området evalueret i kliniske studier (10 til 500 mikrogram per kg).
English: Onpattro has not been studied in patients with moderate or severe hepatic impairment and should not be used in these patients unless the anticipated clinical benefit outweighs the potential risk (see section 5.2).
Danish: Onpattro er ikke blevet undersøgt hos patienter med moderat eller svært nedsat leverfunktion og bør ikke anvendes til disse patienter, medmindre den forventede kliniske fordel opvejer den mulige risiko (se pkt 5.2).
English: Cholesterol
Danish: Kolesterol
English: Anti-drug antibodies to Onpattro were evaluated by measuring antibodies specific to PEG2000-C-DMG, a lipid component exposed on the surface of Onpattro.
Danish: Antistoffer mod Onpattro blev evalueret ved at måle antistoffer specifikke for PEG2000-C-DMG, en lipidkomponent eksponeret på overfladen af Onpattro.
English: 5 mL concentrate in a Type I glass vial with a chlorobutyl stopper and an aluminium flip-off cap.
Danish: 5 ml koncentrat i et type-I hætteglas af glas med en chlorbutylprop og en aftagelig aluminiumshætte.
English: If refrigeration is not available, Onpattro can be stored at room temperature up to 25°C for up to 14 days.
Danish: Hvis der ikke er adgang til et køleskab, kan Onpattro opbevares ved stuetemperatur op til 25 °C i op til 14 dage.
English: Vitamin A supplementation at approximately 2500 IU vitamin A per day is advised for patients treated with Onpattro (see section 4.4).
Danish: Et dagligt tilskud af vitamin A på cirka 2.500 IE vitamin A dagligt tilrådes hos patienter, som behandles med Onpattro (se pkt.
English: This medicinal product contains 3.99 mg sodium per mL, equivalent to 0.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Lægemidlet indeholder 3,99 mg natrium per ml svarende til 0,2 % af det maksimale daglige indtag for voksne på 2 g natrium, som anbefales af Verdenssundhedsorganisationen (World Health Organisation, WHO).
English: Treatment with Onpattro reduces serum TTR levels, which results in reduced levels of retinol binding protein and vitamin A in the serum.
Danish: Behandling med Onpattro reducerer niveauerne af TTR i serum, hvilket medfører reducerede niveauer af retinol-bindende protein og vitamin A i serum.
English: Bronchitis
Danish: Bronkitis
English: Intravenous use after dilution.
Danish: Intravenøs brug efter fortynding.
English: Signs and symptoms included phlebitis or thrombophlebitis, infusion or injection site swelling, dermatitis (subcutaneous inflammation), cellulitis, erythema or injection site redness, burning sensation, or injection site pain.
Danish: Tegn og symptomer inkluderede phlebitis eller trombophlebitis, hævelse på infusions- eller injektionsstedet, dermatitis (subkutan inflammation), cellulitis, erytem eller rødme, en brændende fornemmelse, eller smerter på injektionsstedet.
English: Before each infusion you will be given medicines that help to lower the chance of infusion-related reactions (see “Medicines given during treatment with Onpattro” in section 3).
Danish: Inden hver infusion vil du få medicin, som hjælper med at reducere risikoen for infusionsrelaterede reaktioner (se “Brug af anden medicin sammen med Onpattro” i pkt.
English: Ingredients of Onpattro may pass into breast milk.
Danish: Indholdsstofferne i Onpattro kan udskilles i modermælk.
English: No dose adjustment is necessary in patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥ 30 to < 90 mL/min/1.73m2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR] ≥ 30 til < 90 ml/min/1,73 m2).
English: • The potential for IRRs to occur;
Danish: • muligheden for IRR'er,
English: If you are of childbearing age and intend to use Onpattro, you should practise effective contraception.
Danish: Hvis du er i den fødedygtige alder og planlægger at tage Onpattro, skal du bruge sikker prævention.
English: Symptoms of IRRs include, but are not limited to: arthralgia or pain (including back, neck, or musculoskeletal pain), flushing (including erythema of face or skin warm), nausea, abdominal pain, dyspnoea or cough, chest discomfort or chest pain, headache, rash, chills, dizziness, fatigue, increased heart rate or palpitations, hypotension, hypertension, facial oedema.
Danish: Symptomer på IRR'er inkluderer, men er ikke begrænsede til: Artralgi eller smerter (inklusive smerter i ryg, nakke eller bevægeapparatet), rødmen (inklusive erytem i ansigtet eller varm hud), kvalme, mavesmerter, dyspnø eller hoste, ubehag eller smerter i brystet, hovedpine, udslæt, kulderystelser, svimmelhed, træthed, øget hjertefrekvens eller hjertebanken, hypotension, hypertension, ansigtsødem.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 mg/5 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 10 mg/5 ml
English: Pregnancy, breast-feeding and contraception
Danish: Graviditet, amning og prævention
English: Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during treatment.
Danish: Fortæl det altid omgående til lægen eller sygeplejersken, hvis du får nogen af de følgende tegn på en infusionsrelateret reaktion under behandling.
English: In a threshold analysis of mNIS+7 (change from baseline of < 0 points), 56.1% of Onpattro-treated patients versus 3.9% of placebotreated patients experienced improvement in mNIS+7 (p <0.001).
Danish: I en tærskelanalyse af mNIS+7 (ændring fra baseline på < 0 point) oplevede 56,1 % af patienter behandlet med Onpattro vs. 3,9 % af patienter behandlet med placebo en forbedring i mNIS+7 (p < 0,001).
English: • Decrease in night vision, dry eyes, poor vision, hazy or cloudy vision
Danish: • Nedsat nattesyn, tørre øjne, nedsat syn, sløret eller uklart syn.
English: Serum vitamin A levels below the lower limit of normal should be corrected and any ocular symptoms or signs due to vitamin A deficiency should be evaluated prior to initiation of treatment with Onpattro.
Danish: Serumkoncentrationerne af vitamin A under den nedre normalgrænse bør korrigeres, og eventuelle okulære symptomer eller tegn på A-vitaminmangel skal vurderes før iværksættelse af behandling med Onpattro.
English: Tell your doctor or nurse if you notice any of the side effects listed above.
Danish: Fortæl lægen eller sygeplejersken, hvis du oplever nogen af bivirkningerne angivet ovenfor.
English: In lactating rats, patisiran was not present in milk, although small amounts of the lipid components DLin-MC3-DMA and PEG2000-C-DMG were present in milk (up to 7% of concomitant maternal plasma concentrations).
Danish: Hos diegivende rotter var patisiran ikke tilstede i mælk, omend små mængder af lipidkomponenterne DLin-MC3-DMA og PEG2000-C-DMG var tilstede i mælk (op til 7 % af samtidig maternelle plasmakoncentrationer).
English: In the placebo-controlled study, peripheral oedema was reported in 29.7% of Onpattro-treated patients and 22.1% of placebo-treated patients.
Danish: I det placebokontrollerede studie blev perifert ødem rapporteret hos 29,7 % af patienter behandlet med Onpattro og 22,1 % af patienter behandlet med placebo.
English: • Intravenous corticosteroid (dexamethasone 10 mg, or equivalent)
Danish: • Intravenøst kortikosteroid (dexamethason 10 mg eller tilsvarende)
English: Patisiran and the lipid components exhibit linear and time-independent pharmacokinetics with chronic dosing at the dose regimen of 300 micrograms per kg every 3 weeks.
Danish: Patisiran og lipidkomponenterne udviser lineær og tidsafhængig farmakokinetik med vedvarende dosering ved doseringsregimet på 300 mikrogram per kg hver 3. uge.
English: SD, standard deviation; LS mean, least squares mean; SEM, standard error of the mean; CI, confidence interval, NIS-W, NIS-weakness (motor strength); R-ODS, Rasch-Built Overall Disability (patient reported ability to perform activities of daily living); 10-metre walk test (gait speed); mBMI, modified body mass index (nutritional status); COMPASS 31, Composite Autonomic Symptom Score 31 (patient reported symptom score)
Danish: SD, standardafgivelse; LS gennemsnit, mindste kvadraters metode; SEM, middelfejlen på middeltallet; KI, konfidensinterval, NIS-W, NIS-weakness (motorisk styrke); R-ODS, Rasch-Built Overall Disability (patientrapporteret evne til at udføre dagligdags aktiviteter); 10-meter gangtest (ganghastighed); mBMI, (modificeret kropsmasseindeks [mBMI]) (ernæringstilstand); COMPASS 31, Composite Autonomic Symptom Score 31 (patientrapporteret symptomscore)
English: Onpattro has not been studied in patients with moderate or severe hepatic impairment.
Danish: Onpattro er ikke blevet undersøgt hos patienter med moderat eller svært nedsat leverfunktion.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 10 mg/5 mL
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 10 mg/5 ml
English: The components of Onpattro are not inhibitors or inducers of cytochrome P450 enzymes or transporters, except for CYP2B6 (see Section 4.5).
Danish: Komponenterne i Onpattro er ikke hæmmere eller induktorer af cytokrom P450-enzymer eller-transportere undtagen for CYP2B6 (se pkt.
English: • The other ingredients are DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4- (dimethylamino) butanoate), PEG2000-C-DMG (α- (3'-{[1,2-di(myristyloxy)propanoxy]carbonylamino}propyl)-ω-methoxy, polyoxyethylene), DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), cholesterol, disodium hydrogen phosphate, heptahydrate, potassium dihydrogen phosphate, anhydrous, sodium chloride, and water for injections (see “Onpattro contains sodium” in section 2).
Danish: • Øvrige indholdsstoffer: DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4-(dimethylamino) butanoat), PEG2000-C-DMG (α-(3'-{[1,2-di(myristyloxy)propanoxy]carbonylamino}propyl)-ω-methoxy, polyoxyethylen), DSPC (1,2-distearoyl-sn-glycero-3-phosphocholin), kolesterol, dinatriumhydrogenfosfat, heptahydrat, kaliumdihydrogenfosfat, vandfrit, natriumhlorid, og vand til injektionsvæsker (se “Onpattro indeholder natrium” i pkt.
English: • A dedicated line with an infusion set containing a 1.2 micron PES in-line infusion filter must be used.
Danish: • En dedikeret slange med et infusionssæt, der har et 1,2 mikron PES in-line infusionsfilter skal bruges.
English: The accumulation of AUCτ was 1.76-fold at steady-state compared to the first dose.
Danish: Akkumuleringen af AUCτ var 1,76 gange højere ved steady-state sammenlignet med den første dosis.
English: During the last 6 months of your pregnancy you should resume vitamin A supplementation if the vitamin A levels in your blood have not yet returned to normal, because of an increased risk of vitamin A deficiency during the last 3 months of your pregnancy.
Danish: I løbet af de første 3 måneder kan lægen beslutte, at du skal stoppe med at tage et tilskud af vitamin A. Du bør begynde at tage tilskud af vitamin A igen i graviditetens sidste 6 måneder, hvis niveauerne af vitamin A i dit blod endnu ikke er normale igen, på grund af en forøget risiko for mangel på vitamin A i graviditetens sidste 3 måneder.
English: • The usual dose of Onpattro is 300 micrograms per kilogram (kg) of body weight given once every
Danish: • Den sædvanlige dosis af Onpattro er 300 mikrogram per kilogram (kg) legemsvægt indgivet en gang hver 3. uge.
English: • Chest discomfort or chest pain
Danish: • Ubehag eller smerter i brystet
English: In patients experiencing an IRR, the majority experienced the first IRR within the first 2 infusions (see section 4.8).
Danish: De fleste patienter, som havde en IRR, oplevede deres første IRR i forbindelse med de første 2 infusioner (se pkt.
English: By reducing serum TTR protein, Onpattro treatment leads to a decrease in serum vitamin A (retinol) levels (see section 5.1).
Danish: Ved at reducere TTR protein i serum, medfører behandling med Onpattro en reduktion i vitamin A (retinol) niveauerne i serum (se pkt.