FrancophonIA/ELRC3.0 huggingface dataset:
English: • If Onpattro is administered within 3 days of the missed dose, dosing should be continued according to the patient's original schedule.
Croatian: • Ako se Onpattro primijeni u roku od 3 dana od propuštene doze, treba nastaviti s doziranjem prema bolesnikovu početnom rasporedu.
English: • Onpattro is supplied in cartons containing one vial each.
Croatian: • Onpattro se isporučuje u kutijama u kojima se nalazi po jedna bočica.
English: Approximately half of patients (56%) met pre-defined criteria for cardiac involvement (defined as baseline LV wall thickness ≥ 13 mm with no history of hypertension or aortic valve disease).
Croatian: Otprilike polovica bolesnika (56 %) zadovoljila je prethodno utvrđene kriterije zahvaćenosti srca (definirane kao početna debljina stijenke lijeve klijetke ≥ 13 mm bez prethodno poznate hipertenzije ili bolesti aortnog zaliska).
English: Onpattro is believed to have no or negligible influence on the ability to drive or use machines.
Croatian: Smatra se da Onpattro ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Patisiran is formulated as lipid nanoparticles to deliver the siRNA to hepatocytes, the primary source of TTR protein in the circulation.
Croatian: Patisiran je formuliran u obliku lipidnih nanočestica radi dopremanja siRNA do hepatocita, primarnog izvora proteina TTR u krvotoku.
English: Additional or higher doses of one or more of the premedications may be administered to reduce the risk of IRRs, if needed (see sections 4.4 and 4.8).
Croatian: Za smanjenje rizika od reakcija povezanih s infuzijom mogu se primijeniti dodatne ili veće doze jedne ili više premedikacija, ako je to potrebno (vidjeti dijelove 4.4 i 4.8).
English: Plasma protein binding of Onpattro is low, with ≤ 2.1% binding observed in vitro with human serum albumin and human α1-acid glycoprotein.
Croatian: Vezanje lijeka Onpattro za proteine u plazmi je nisko, s time da je zabilježeno ≤ 2,1 % vezanja in vitro za humani serumski albumin i humani α1-kiseli glikoprotein.
English: N-terminal pro-B type natriuretic peptide (NT-proBNP) was 727 ng/L and 711 ng/L at baseline (geometric mean) in Onpattro-treated and placebo-treated patients, respectively.
Croatian: N-terminalni natrijuretički peptid pro-B tipa (NT-proBNP) bio je 727 ng/l i 711 ng/l na početnom pregledu (geometrijska sredina) bolesnika liječenih lijekom Onpattro odnosno bolesnika koji su primali placebo.
English: • If Onpattro is administered more than 3 days after the missed dose, dosing should be continued every 3 weeks thereafter.
Croatian: • Ako se Onpattro primijeni više od 3 dana od propuštene doze, treba nastaviti s doziranjem svaka
English: What Onpattro is and what it is used for What you need to know before you are given Onpattro How Onpattro is given
Croatian: Što je Onpattro i za što se koristi Što trebate znati prije primanja lijeka Onpattro
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.
Croatian: Povećanje doze patisirana rezultiralo je većim smanjenjem proteina TTR, s time da su najveća smanjenja dostigla plato pri izlaganju patisiranu postignutom uz doziranje od 300 mikrograma po kg svaka 3 tjedna.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 mg/5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 10 mg/5 ml
English: 3 weeks.
Croatian: 3 tjedna nakon toga.
English: The efficacy of Onpattro was studied in a randomised, double-blind, placebo-controlled study in 225 hATTR amyloidosis patients with a TTR mutation and symptomatic polyneuropathy.
Croatian: Djelotvornost lijeka Onpattro ispitivana je u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju na 225 bolesnika s hATTR amiloidozom s mutacijom TTR-a i simptomatskom polineuropatijom.
English: How long to use Onpattro
Croatian: Koliko dugo treba uzimati Onpattro
English: Medicines given during treatment with Onpattro Before each infusion of Onpattro, you will be given medicines that help to lower the risk of infusionrelated reactions.
Croatian: Lijekovi koje ćete primiti tijekom liječenja lijekom Onpattro Prije svake infuzije lijeka Onpattro primit ćete lijekove koji pomažu smanjiti rizik od reakcija povezanih s infuzijom.
English: DLin-MC3-DMA is primarily metabolised to 4-dimethylaminobutyric acid (DMBA) by hydrolysis.
Croatian: DLin-MC3-DMA se primarno metabolizira hidrolizom u 4-dimetilaminobutiratnu kiselinu (DMBA).
English: • The diluted solution of Onpattro should be infused intravenously over approximately 80 minutes at an initial infusion rate of approximately 1 mL/min for the first 15 minutes, followed by an increase to approximately 3 mL/min for the remainder of the infusion.
Croatian: • Razrijeđenu otopinu lijeka Onpattro treba primjenjivati putem intravenske infuzije približno 80 minuta početnom brzinom infuzije od približno 1 ml/min prvih 15 minuta, a zatim povećati brzinu na približno 3 ml/min za ostatak infuzije.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 10 mg/5 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 10 mg/5 ml
English: Ingredients of Onpattro may pass into breast milk.
Croatian: Sastojci lijeka Onpattro mogu se izlučiti u majčino mlijeko.
English: PEG2000-C-DMG excretion in humans was not measured.
Croatian: Izlučivanje PEG2000-C-DMG u ljudi nije izmjereno.
English: The primary efficacy endpoint was the change from baseline to 18 months in modified Neuropathy Impairment Score +7 (mNIS+7).
Croatian: Primarna mjera ishoda djelotvornosti bila je promjena od početnih vrijednosti do 18 mjeseci u modificiranoj ocjeni neuropatološkog oštećenja +7 (engl. modified Neuropathy Impairment Score, mNIS+7).
English: Patients were randomised 2:1 to receive 300 micrograms per kg Onpattro or placebo via intravenous infusion once every 3 weeks for 18 months.
Croatian: Bolesnici su randomizirani u omjeru 2 : 1 za primanje 300 mikrograma po kg lijeka Onpattro ili placeba intravenskom infuzijom jednom svaka 3 tjedna tijekom 18 mjeseci.
English: Onpattro works by lowering the amount of TTR protein that the liver makes.
Croatian: Onpattro djeluje tako što smanjuje količinu proteina TTR koje stvara jetra.
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%).
Croatian: Demografske i početne karakteristike bolesnika bile su ujednačene među terapijskim skupinama, s time da je udio bolesnika u skupini koja je primala Onpattro s mutacijom koja nije V30M bio veći (62 % u odnosu na 48 %).
English: If you are of childbearing age and intend to use Onpattro, you should practise effective contraception.
Croatian: Ako ste u reproduktivnoj dobi i namjeravate se liječiti lijekom Onpattro, morate primjenjivati učinkovitu kontracepciju.
English: The key secondary endpoint was the change from baseline to 18 months in Norfolk Quality of LifeDiabetic Neuropathy (QoL-DN) total score.
Croatian: Ključna sekundarna mjera ishoda bila je promjena od početne vrijednosti do 18 mjeseci u ukupnom rezultatu upitnika Norfolk Quality of Life-Diabetic Neuropathy (QoL DN).
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).
Croatian: Izloženost patisiranu i lipidnim komponentama (DLin-MC3-DMA i PEG2000-C-DMG) povećavala se razmjerno povećanju doze kroz raspon procijenjen u kliničkim ispitivanjima (10 do 500 mikrograma po kg).
English: • Cough, feeling short of breath, or other breathing problems
Croatian: • kašalj, nedostatak zraka i ostale poteškoće s disanjem
English: • Withdraw the required volume of filtered Onpattro from the sterile container using a sterile syringe.
Croatian: • Izvucite potrebni volumen filtriranog lijeka Onpattro iz sterilnog spremnika pomoću sterilne štrcaljke.
English: Among Onpattro-treated patients who experienced an IRR, 78.6% experienced the first IRR within the first 2 infusions.
Croatian: Među bolesnicima liječenim lijekom Onpattro koji su doživjeli reakciju povezanu s infuzijom, 78,6 % njih je prvu reakciju povezanu s infuzijom imalo unutar prve 2 infuzije.
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).
Croatian: Na početnom pregledu, 46 % bolesnika imalo je bolest 1. stadija (nenarušeni hod; uglavnom blaga senzorna, motorička i autonomna neuropatija u donjim ekstremitetima), a 53 % imalo je bolest 2. stadija (potrebna pomoć pri hodu; uglavnom umjerena progresija oštećenja na donje ekstremitete, gornje ekstremitete i trup).
English: Marketing Authorisation Holder Alnylam Netherlands B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Alnylam Netherlands B.V.
English: In rats and monkeys, PEG2000-C-DMG is eliminated unchanged in the bile.
Croatian: U štakora i majmuna PEG2000-C-DMG izlučuje se nepromijenjen putem žuči.
English: • The appropriate infusion rate;
Croatian: • odgovarajućoj brzini infuzije
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Croatian: Druge nuspojave Obavijestite svojeg liječnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava:
English: Bronchitis
Croatian: Bronhitis
English: There were no adverse effects on the pups.
Croatian: U mladunaca nije bilo nuspojava.
English: Forty-nine percent (49%) and 50% of patients had a New York Heart Association (NYHA) Class of I or II, respectively.
Croatian: Četrdeset i devet posto (49 %) i 50 % bolesnika imalo je poteškoće razreda I. odnosno II. prema klasifikaciji NYHA (engl.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane redoslijedom padajuće ozbiljnosti.
English: Serum TTR reduction was maintained with continued dosing.
Croatian: Smanjenje proteina TTR u serumu održano je uz nastavak doziranja.
English: If you miss your dose of Onpattro
Croatian: Ako propustite dozu lijeka Onpattro
English: There was no accumulation of AUCτ at steady-state compared to the first dose.
Croatian: Nije bilo akumulacije AUCτ u stanju dinamičke ravnoteže u odnosu na prvu dozu.
English: If an IRR occurs, slowing or interrupting the infusion and institution of medical management (e.g., corticosteroids or other symptomatic treatment) should be considered, as clinically indicated.
Croatian: Ako se pojavi reakcija povezana s infuzijom, treba razmotriti mogućnost usporavanja ili prekida infuzije i medicinskog zbrinjavanja (npr. kortikosteroidima ili drugim simptomatskim liječenjem) prema kliničkim indikacijama.
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.
Croatian: Intravenska primjena lijeka Onpattro dovela je do povećanja jetrenih proba u serumu (ALT, AST, ALP i/ili ukupni bilirubin) i histopatoloških nalaza jetre (nekroza jetrenih/pojedinačnih stanica, upala, odlaganje pigmenta i/ili infiltracija monocita) pri dozama > 100 mikrograma po kg svaka 4 tjedna i > 1,0 mg/kg svaka 3 tjedna kod štakora odnosno majmuna.
English: By reducing serum TTR protein, Onpattro treatment leads to a decrease in serum vitamin A (retinol) levels (see section 5.1).
Croatian: Zbog smanjenja proteina TTR u serumu, liječenje lijekom Onpattro uzrokuje smanjenje razine vitamina A (retinola) u serumu (vidjeti dio 5.1).
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).
Croatian: Kod ženki štakora u laktaciji, patisiran nije bio prisutan u mlijeku, iako su male količine lipidnih komponenata DLin-MC3-DMA i PEG2000-C-DMG bile prisutne u mlijeku (do 7 % istodobnih koncentracija u majčinoj plazmi).
English: Across clinical studies, the most common symptoms (reported in ≥ 2% of patients) of IRRs were flushing, back pain, nausea, abdominal pain, dyspnoea, and headache.
Croatian: U kliničkim ispitivanjima najčešći simptomi (prijavljeni u ≥ 2 % bolesnika) reakcija povezanih s infuzijom bili su navale crvenila, bol u leđima, mučnina, bol u abdomenu, dispneja i glavobolja.
English: 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)
Croatian: Dlin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriakonta-6,9,28,31-tetraen-19-il-4-(dimetilamino) butanoat) PEG2000-C-DMG (α-(3'-{[1,2-di(miristiloksi)propanoksi]karbonilamin}propil)-ω-metoksi, polioksietilen)
English: The frequency of the adverse reactions is expressed according to the following categories:
Croatian: Učestalost nuspojava iskazana je u skladu sa sljedećim kategorijama:
English: During the first 60 days of pregnancy, both too high or too low vitamin A levels may be associated with an increased risk of foetal malformation.
Croatian: Tijekom prvih 60 dana trudnoće previsoka ili preniska razina vitamina
English: • Filter Onpattro through a sterile 0.45 micron polyethersulfone (PES) syringe filter into a sterile container.
Croatian: • Filtrirajte Onpattro kroz sterilni filtar za štrcaljke veličine 0,45 mikrona od polietersulfona (PES) u sterilni spremnik.
English: In the placebo-controlled study, peripheral oedema was reported in 29.7% of Onpattro-treated patients and 22.1% of placebo-treated patients.
Croatian: U placebom kontroliranom ispitivanju, periferni edem prijavljen je u 29,7 % bolesnika liječenih lijekom Onpattro i 22,1 % bolesnika koji su primali placebo.
English: Onpattro must be diluted with sodium chloride 9 mg/mL (0.9%) solution prior to intravenous infusion.
Croatian: Onpattro se mora razrijediti otopinom natrijeva klorida od 9 mg/ml (0,9 %) prije intravenske infuzije.
English: • Reasons triggering HCPs to consider whether the patient should stop home infusions and return to the clinic to receive the infusions.
Croatian: • razlozima koji će liječnike potaknuti na procjenu mora li bolesnik prestati primati infuzije kod kuće i nastaviti s infuzijama u bolnici.
English: Some patients who experience IRRs may benefit from a slower infusion rate or additional or higher doses of one or more of the premedications with subsequent infusions to reduce the risk of IRRs.
Croatian: Za neke od bolesnika koji dožive reakcije povezane s infuzijom može biti pogodna manja brzina infuzije ili dodatne ili veće doze jedne ili više premedikacija uz kasnije infuzije radi smanjenja rizika od reakcija povezanih s infuzijom.
English: How Onpattro is given
Croatian: Kako se Onpattro daje
English: • The usual dose of Onpattro is 300 micrograms per kilogram (kg) of body weight given once every
Croatian: • Uobičajena doza lijeka Onpattro je 300 mikrograma po kilogramu (kg) tjelesne težine koja se daje jednom svaka 3 tjedna.
English: In spleen, lymphoid atrophy/necrosis and histiocytosis in the white pulp was observed in rats and hypocellularity of the red pulp was observed in monkeys.
Croatian: U slezeni štakora zabilježena je limfoidna atrofija/nekroza i histiocitoza u bijeloj pulpi, a u slezeni majmuna zabilježena je hipocelularnost crvene pulpe.
English: The duration of infusion may be extended in the event of an IRR (see section 4.4).
Croatian: Trajanje infuzije može se produžiti u slučaju reakcije povezane s infuzijom (vidjeti dio 4.4).
English: Onpattro is a medicine that treats an illness which runs in families called hereditary ATTR (hATTR) amyloidosis.
Croatian: Onpattro je lijek za liječenje nasljedne bolesti koja se naziva nasljedna ATTR (hATTR) amiloidoza.
English: DLin-MC3-DMA
Croatian: DLin-MC3-DMA PEG2000-C-DMG
English: Women of childbearing potential have to use effective contraception during treatment with Onpattro.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Onpattro.
English: At the dose regimen of 300 micrograms per kg every 3 weeks, steady state was reached by 24 weeks of treatment.
Croatian: Uz režim doziranja od 300 mikrograma po kg svaka 3 tjedna, stanje dinamičke ravnoteže postignuto je nakon 24 tjedna liječenja.
English: Onpattro is a white to off-white, opalescent, homogeneous solution.
Croatian: Onpattro je bijela do bjelkasta, opalescentna, homogena otopina.
English: In clinical studies, all patients received premedication with a corticosteroid, paracetamol, and H1 and H2 blockers to reduce the risk of IRRs.
Croatian: U kliničkim ispitivanjima svi su bolesnici primili premedikaciju kortikosteroida, paracetamola, te H1 i H2 blokatora radi smanjenja rizika od reakcija povezanih s infuzijom.
English: In patients experiencing an IRR, the majority experienced the first IRR within the first 2 infusions (see section 4.8).
Croatian: Većina bolesnika koja je doživjela reakciju povezanu s infuzijom doživjela je prvu takvu reakciju unutar prve 2 infuzije (vidjeti dio 4.8).
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.
Croatian: U 18. mjesecu, zabilježena je korist uz lijek Onpattro u odnosu na placebo u svim domenama upitnika Norfolk QoL DN, a 51,4 % bolesnika liječenih lijekom Onpattro osjetilo je poboljšanje kvalitete života (Norfolk QoL-DN promjena od početne vrijednosti < 0 bodova), u usporedbi s 10,4 %
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).
Croatian: • Drugi sastojci su Dlin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriakonta-6,9,28,31-tetraen-19-il-4-(dimetilamino) butanoat), PEG2000-C-DMG (α-(3'-{[1,2-di(miristiloksi)propanoksi]karbonilamin}propil)-ω-metoksi, polioksietilen), DSPC (1,2-distearoil-sn-glicero-3-fosfokolin), kolesterol, natrijev hidrogenfosfat heptahidrat, bezvodni kalijev dihidrogenfosfat, natrijev klorid i voda za injekcije (vidjeti „Onpattro sadrži natrij” u dijelu 2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml sadrži patisirannatrij u količini koja odgovara 2 mg patisirana.
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.
Croatian: Znakovi i simptomi uključivali su flebitis ili tromboflebitis, oticanje na mjestu primjene infuzije ili injekcije, dermatitis (potkožna upala), celulitis, eritem ili crvenilo na mjestu primjene injekcije, osjećaj žarenja ili bol na mjestu primjene injekcije.
English: • Dilute the required volume of filtered Onpattro into an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for a total volume of 200 mL.
Croatian: • Razrijedite potrebni volumen filtriranog lijeka Onpattro u vrećici za infuziju koja sadrži otopinu natrijeva klorida od 9 mg/ml (0,9 %) do ukupnog volumena od 200 ml.
English: As a precautionary measure, vitamin A and thyroid stimulating hormone (TSH) levels should be obtained early in pregnancy (see section 5.3).
Croatian: A i razinu stimulirajućeg hormona štitnjače (engl. thyroid stimulating hormone, TSH) potrebno je izmjeriti u ranoj trudnoći (vidjeti dio 5.3).
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.
Croatian: Protutijela na lijek Onpattro ocijenjena su mjerenjem protutijela specifičnih za PEG2000-C-DMG, lipidnu komponentu izloženu na površini lijeka Onpattro.
English: Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during treatment.
Croatian: Odmah se obratite svojem liječniku ili medicinskoj sestri ako primijetite bilo koji od sljedećih znakova reakcije povezane s infuzijom tijekom liječenja.
English: Approximately 5.5% of DLin-MC3-DMA was recovered after 96 hours as its metabolite (DMBA) in urine.
Croatian: Nakon 96 sati u urinu je bilo izlučeno približno 5,5 % DLin-MC3-DMA u obliku metabolita (DMBA).
English: Liver transplant
Croatian: Presađena jetra
English: No impact on male or female fertility was detected in animal studies (see section 5.3).
Croatian: U ispitivanjima na životinjama nije zabilježen utjecaj na plodnost u mužjaka ili ženki (vidjeti dio 5.3).
English: • Redness of the skin (erythema)
Croatian: • crvenilo kože (eritem)
English: If refrigeration is not available, Onpattro can be stored at room temperature (up to 25°C) for up to 14 days.
Croatian: Ako Onpattro nije moguće čuvati u hladnjaku, može se čuvati na sobnoj temperaturi (do 25 °C) do 14 dana.
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.
Croatian: Patisiran i lipidne komponente pokazuju linearnu i vremenski neovisnu farmakokinetiku kod kronične primjene uz režim doziranja od 300 mikrograma po kg svaka 3 tjedna.
English: At 18 months, the adjusted geometric mean ratio to baseline was 0.89 with Onpattro and 1.97 with placebo (ratio, 0.45; p < 0.001), representing a 55% difference in favour of Onpattro.
Croatian: U 18. mjesecu prilagođeni omjer geometrijskih sredina u odnosu na početne vrijednosti iznosio je 0,89 uz Onpattro i 1,97 u onih koji su primali placebo (omjer 0,45; p < 0,001), što čini razliku od 55 % u prilog lijeku Onpattro.
English: Vitamin A deficiency
Croatian: Nedostatak vitamina
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).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega (procijenjena brzina glomerularne filtracije [engl. estimated glomerular filtration rate, eGFR] ≥ 30 do < 90 ml/min/1,73m2).
English: For premedications not available or not tolerated intravenously, equivalents may be administered orally.
Croatian: U slučaju da neke od premedikacija nisu dostupne ili ih bolesnici ne podnose intravenskom primjenom, mogu se primijeniti ekvivalenti oralnim putem.
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).
Croatian: U analizi graničnih vrijednosti za rezultat mNIS+7 (promjena u odnosu na početnu vrijednost od < 0 bodova) u 56,1 % bolesnika liječenih lijekom Onpattro došlo je do poboljšanja u rezultatu mNIS+7 (p < 0,001) u usporedbi s 3,9 %
English: Available toxicological data in animals have shown excretion of small amounts of the lipid components DLin-MC3-DMA and PEG2000-C-DMG in milk (see section 5.3).
Croatian: Dostupni toksikološki podaci u životinja pokazuju da dolazi do izlučivanja manjih količina lipidnih komponenti DLin-MC3-DMA i PEG2000-C-DMG u mlijeko (vidjeti dio 5.3).