FrancophonIA/ELRC3.0 huggingface dataset:
English: A97S (9%), T60A (7%), E89Q (6%), and S50R (5%).
Croatian: Bilo je zastupljeno trideset i devet (39) različitih mutacija TTR-a; najčešće (≥ 5 %) su bile V30M (43 %), A97S (9 %), T60A (7 %), E89Q (6 %) i S50R (5 %).
English: Each of the following medicinal products should be given on the day of Onpattro infusion at least 60 minutes prior to the start of infusion:
Croatian: Na dan infuzije lijeka Onpattro potrebno je primijeniti sve sljedeće lijekove najmanje 60 minuta prije početka infuzije:
English: The Norfolk QoL-DN questionnaire (patient-reported) includes domains relating to small fibre, large fibre, and autonomic nerve function, symptoms, and activities of daily living, with the total score ranging from -4 to 136, where an increasing score indicates worsening quality of life.
Croatian: (vlastita procjena bolesnika) sadrži domene koje se odnose na funkciju tankih i debelih živčanih vlakana te autonomnu živčanu funkciju, simptome i aktivnosti svakodnevnog života, s ukupnim rezultatom u rasponu od -4 do 136, pri čemu rastući rezultat upućuje na pogoršanje kvalitete života.
English: It is unknown whether Onpattro is excreted in human milk.
Croatian: Nije poznato izlučuje li se Onpattro u majčino mlijeko.
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).
Croatian: Onpattro nije ispitan u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre i ne smije se primjenjivati u tih bolesnika osim u slučaju da očekivana klinička korist nadmašuje potencijalni rizik (vidjeti dio 5.2).
English: Therefore, pregnancy should be excluded before initiation of treatment and women of childbearing potential should use effective contraception.
Croatian: Zbog toga je potrebno isključiti mogućnost trudnoće prije započinjanja liječenja, a žene reproduktivnog potencijala moraju primjenjivati učinkovitu kontracepciju.
English: However, transport and tissue uptake of vitamin A can occur through alternative mechanisms in the absence of retinol binding protein.
Croatian: A u tkivo može nastupiti putem drugih mehanizama u nedostatku retinol-vezujućeg proteina.
English: The recommended dose of Onpattro is 300 micrograms per kg body weight administered via intravenous (IV) infusion once every 3 weeks.
Croatian: Preporučena doza lijeka Onpattro je 300 mikrograma po kg tjelesne težine primijenjeno putem intravenske (i.v.) infuzije jednom svaka 3 tjedna.
English: • Common (≥ 1/100 to < 1/10) • Uncommon (≥ 1/1,000 to < 1/100)
Croatian: • Manje često (≥ 1/1000 i < 1/100)
English: • If you have any further questions, ask your doctor or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se svojem liječniku ili medicinskoj sestri.
English: If you miss an appointment to have Onpattro, ask your doctor or nurse when to book your next treatment.
Croatian: Ako propustite zakazani termin za primanje lijeka Onpattro, pitajte svojeg liječnika ili medicinsku sestru o zakazivanju sljedećeg termina.
English: Pregnancy should be excluded before starting treatment with Onpattro.
Croatian: Potrebno je isključiti mogućnost trudnoće prije početka liječenja lijekom Onpattro.
English: At the dose regimen of 300 micrograms per kg every 3 weeks, mean ± SD steady state plasma clearance (CLss) of patisiran was 3.0 ± 2.5 mL/h/kg.
Croatian: Uz režim doziranja od 300 mikrograma po kg svaka 3 tjedna, srednja vrijednost ± SD klirensa patisirana iz plazme u stanju dinamičke ravnoteže (CLss) bila je 3,0 ± 2,5 ml/h/kg.
English: What Onpattro contains
Croatian: Što sadrži Onpattro
English: In the unlikely event that you are given too much (an overdose) your doctor or nurse will check you for side effects.
Croatian: Iako to nije vjerojatno, ako primite previše lijeka (prekomjernu dozu), Vaš će liječnik ili medicinska sestra provjeriti imate li nuspojava.
English: Each mL contains 2 mg patisiran.
Croatian: Jedan ml sadrži 2 mg patisirana.
English: Serum TTR is a carrier of retinol binding protein, which facilitates transport of vitamin A in the blood.
Croatian: Serumski TTR nositelj je retinol-vezujućeg proteina koji omogućuje prijenos vitamina A u krvi.
English: Clinical studies did not identify significant differences in steady state pharmacokinetic parameters or TTR reduction according to gender or race (non-Caucasian vs. Caucasian).
Croatian: Na temelju kliničkih ispitivanja nisu utvrđene značajne razlike u farmakokinetičkim parametrima u stanju dinamičke ravnoteže ili smanjenju proteina TTR prema spolu ili rasi (ne-bijela u odnosu na bijelu rasu).
English: Each mL of concentrate contains 3.99 mg sodium.
Croatian: Pomoćne tvari s poznatim učinkom Jedan ml koncentrata sadrži 3,99 mg natrija.
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.
Croatian: Ovaj lijek sadrži 3,99 mg natrija po ml, što je jednako 0,2 % maksimalnog dnevnog unosa od 2 g natrija prema preporuci Svjetske zdravstvene organizacije (engl.
English: All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs) (see section 4.4).
Croatian: Svi bolesnici trebaju primiti premedikaciju prije primjene lijeka Onpattro radi smanjenja rizika od reakcija povezanih s infuzijom (vidjeti dio 4.4).
English: In rabbits, Onpattro generated spontaneous abortions, reduced embryo-foetal survival, and reduced foetal body weights at maternally toxic doses ≥ 1 mg/kg (HED 3.2 times the RHD).
Croatian: U kunića je Onpattro doveo do spontanih pobačaja, smanjenog embrio-fetalnog preživljenja i smanjenja tjelesne težine fetusa pri dozama toksičnim za majku ≥ 1 mg/kg (ekvivalent doze za ljude je 3,2 puta preporučena doza za ljude).
English: • Onpattro must be administered through a secure and free-flowing venous access line.
Croatian: • Onpattro se mora primjenjivati kroz cjevčicu za venski pristup sigurnog i neometanog protoka.
English: For clinical management of IRRs, see section 4.4.
Croatian: Za kliničko zbrinjavanje reakcija povezanih s infuzijom vidjeti dio 4.4.
English: Onpattro has not been studied in patients with severe renal impairment or end-stage renal disease and should not be used in these patients unless the anticipated clinical benefit outweighs the potential risk (see section 5.2).
Croatian: Onpattro nije ispitan u bolesnika s teškim oštećenjem funkcije bubrega ili završnim stadijem bubrežne bolesti i ne smije se primjenjivati u tih bolesnika osim u slučaju da očekivana klinička korist nadmašuje potencijalni rizik (vidjeti dio 5.2).
English: Few IRRs led to infusion interruption.
Croatian: Mali broj reakcija povezanih s infuzijom zahtijevao je prekid infuzije.
English: Severe hypersensitivity (e.g., anaphylaxis) to the active substance or any of the excipients listed in section 6.1.
Croatian: Teška preosjetljivost (npr. anafilaksija) na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu
English: • Rapid heart rate
Croatian: • ubrzan puls
English: Onpattro is for intravenous use.
Croatian: Onpattro je namijenjen za intravensku primjenu.
English: • Intravenous H2 blocker (ranitidine 50 mg, or equivalent)
Croatian: • Intravenski H2 blokator (50 mg ranitidina ili ekvivalent)
English: • Intravenous corticosteroid (dexamethasone 10 mg, or equivalent)
Croatian: • Intravenski kortikosteroid (10 mg deksametazona ili ekvivalent)
English: The components of Onpattro are not inhibitors or inducers of cytochrome P450 enzymes or transporters, except for CYP2B6 (see Section 4.5).
Croatian: P450 ni transporteri, osim za CYP2B6 (vidjeti dio 4.5).
English: In Onpattro-treated patients, all IRRs were either mild (95.2%) or moderate (4.8%) in severity.
Croatian: U bolesnika liječenih lijekom Onpattro, sve su reakcije povezane s infuzijom bile ili blage (95,2 %) ili umjerene (4,8 %) težine.
English: • Inspect visually for particulate matter and discolouration.
Croatian: • Vizualno provjerite lijek za prisutnost čestica i promjenu boje.
English: • How the infusion is given;
Croatian: • tome kako se daje infuzija
English: • Feeling dizzy or faint (vertigo)
Croatian: • omaglica ili vrtoglavica (vertigo)
English: At the dose regimen of 300 micrograms per kg every 3 weeks, the mean ± SD steady-state volume of distribution (Vss) of patisiran, DLin-MC3-DMA and PEG2000-C-DMG was 0.26 ± 0.20 L/kg, 0.47 ± 0.24 L/kg and 0.13 ± 0.05 L/kg, respectively.
Croatian: Uz režim doziranja od 300 mikrograma po kg svaka 3 tjedna, srednja vrijednost ± SD volumena distribucije (Vss) patisirana, DLin-MC3-DMA i PEG2000-C-DMG u stanju dinamičke vrijednosti bila je 0,26 ± 0,20 l/kg, 0,47 ± 0,24 l/kg odnosno 0,13 ± 0,05 l/kg.
English: Treatment with Onpattro reduces serum TTR levels, which results in reduced levels of retinol binding protein and vitamin A in the serum.
Croatian: Liječenje lijekom Onpattro smanjuje razine proteina TTR u serumu, što za posljedicu ima smanjenje razine retinol-vezujućeg proteina i vitamina A u serumu.
English: If clinically indicated, the corticosteroid may be tapered in decrements no greater than 2.5 mg to a minimum dose of 5 mg of dexamethasone (intravenous, IV), or equivalent.
Croatian: Ako je klinički indicirano, doza kortikosteroida može se postepeno smanjivati u koracima ne većim od 2,5 mg do najmanje doze od 5 mg deksametazona (intravenski, i.v.) ili ekvivalenta.
English: Onpattro has not been studied in patients with moderate or severe hepatic impairment.
Croatian: Onpattro nije ispitan u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre.
English: The frequency of IRRs decreased over time.
Croatian: Učestalost reakcija povezanih s infuzijom smanjila se s vremenom.
English: Do not stop treatment with Onpattro unless your doctor tells you to.
Croatian: Nemojte prekidati liječenje lijekom Onpattro bez prethodne upute svojeg liječnika.
English: Thereafter, vitamin A supplementation of 2500 IU per day should be resumed in the second and third trimesters if serum vitamin A levels have not returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
Croatian: A u serumu nije vratila na normalne vrijednosti, potrebno je nastaviti s nadomještanjem vitamina A u dozi od 2500 IU dnevno u drugom i trećem tromjesečju zbog povećanog rizika od nedostatka vitamina A u trećem tromjesečju.
English: • Bupropion, a medicine used to treat depression or to help you to stop smoking
Croatian: • bupropion, lijek koji se primjenjuje za liječenje depresije ili kao pomoć pri prestanku pušenja • efavirenz, lijek koji se primjenjuje za liječenje infekcije HIV-om i AIDS-a.
English: If clinically indicated, the corticosteroid may be tapered in decrements no greater than 2.5 mg to a minimum dose of 5 mg of dexamethasone (IV), or equivalent.
Croatian: Ako je klinički indicirano, doza kortikosteroida može se postupno smanjivati u koracima ne većim od 2,5 mg do najmanje doze od 5 mg deksametazona (i.v.) ili ekvivalenta.
English: Onpattro 2 mg/mL concentrate for solution for infusion patisiran
Croatian: Onpattro 2 mg/ml koncentrat za otopinu za infuziju patisiran
English: • Chest discomfort or chest pain
Croatian: • nelagoda ili bol u prsnom košu
English: The pharmacokinetic properties of Onpattro were characterised by measuring the plasma concentrations of patisiran and the lipid components DLin-MC3-DMA and PEG2000-C-DMG.
Croatian: Farmakokinetička svojstva lijeka Onpattro okarakterizirana su mjerenjem koncentracija patisirana u plazmi te lipidnih komponenti DLin-MC3-DMA i PEG2000-C-DMG.
English: If you are a woman of child-bearing age, you should practice effective contraception during treatment with Onpattro.
Croatian: Ako ste žena reproduktivne dobi, trebate primjenjivati učinkovitu kontracepciju tijekom liječenja lijekom Onpattro.
English: Change from Baseline at 18 months, LS Mean (SEM)
Croatian: Promjena od početne vrijednosti do 18. mjeseca, srednja vrijednost LS (SEM)
English: The duration of infusion may be extended in the event of an IRR.
Croatian: Trajanje infuzije može se produžiti u slučaju reakcije povezane s infuzijom.
English: How to store Onpattro
Croatian: Kako čuvati Onpattro
English: Changes were also seen at 9 months, the first post-baseline assessment in the study, where treatment with Onpattro led to a 16.0-point treatment difference, with a mean change from baseline of -2.0 points, compared to an increase of 14.0 points with placebo.
Croatian: Promjene su također zabilježene u 9. mjesecu, kod prve procjene nakon početne u ispitivanju, kada je primjena lijeka Onpattro dovela do razlike u liječenju od 16,0 bodova,
English: Your doctor will ask you to take a daily vitamin A supplement during treatment with Onpattro.
Croatian: Liječnik će Vas zamoliti da svakodnevno uzimate nadomjestak vitamina
English: In the placebo-controlled study, 62 (41.9%) patients treated with Onpattro were ≥ 65 years of age and
Croatian: U placebom kontroliranom ispitivanju, 62 (41,9 %) bolesnika liječena lijekom Onpattro bila su u dobi od ≥ 65 godina, a 9 (6,1 %) bolesnika bilo je u dobi od ≥ 75 godina.
English: Disodium hydrogen phosphate, heptahydrate Potassium dihydrogen phosphate, anhydrous Sodium chloride
Croatian: Natrijev hidrogenfosfat, heptahidrat Kalijev dihidrogenfosfat, bezvodni Natrijev klorid
English: In the double-blind placebo-controlled study, 18.9% of Onpattro-treated patients experienced IRRs, compared to 9.1% of placebo-treated patients.
Croatian: U dvostruko slijepom placebom kontroliranom ispitivanju 18,9 % bolesnika liječenih lijekom Onpattro imalo je reakcije povezane s infuzijom, u usporedbi s 9,1 % bolesnika koji su primali placebo.
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
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)
Croatian: NIS-weakness (motorička snaga); R-ODS, Opća onesposobljenost po Rasch Builtu (sposobnost za obavljanje svakodnevnih aktivnosti prema procjeni bolesnika); test hoda na 10 metara (brzina hoda); mBMI, modificirani indeks tjelesne mase (status uhranjenosti); COMPASS 31, engl.
English: Disodium hydrogen phosphate, heptahydrate
Croatian: Natrijev hidrogenfosfat, heptahidrat
English: • After completion of the infusion, the intravenous administration set should be flushed with sodium chloride 9 mg/mL (0.9%) solution to ensure that all medicinal product has been administered.
Croatian: • Nakon završetka infuzije, komplet za intravensku primjenu treba isprati otopinom natrijeva klorida od 9 mg/ml (0,9 %) kako biste bili sigurni da je primijenjen sav lijek.
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.
Croatian: Bolesnici koji su primali Onpattro doživjeli su slične koristi u odnosu na placebo u rezultatima mNIS+7 i Norfolk QoL-DN u svim podskupinama, uključujući dob, spol, rasu, područje, rezultat NIS,
English: • Stuffy or runny nose (rhinitis)
Croatian: • začepljen nos ili curenje nosa (rinitis)
English: Tell your doctor or nurse straight away if you get any signs of an infusion-related reaction.
Croatian: Odmah se obratite svojem liječniku ili medicinskoj sestri ako primijetite znakove reakcije povezane s infuzijom.
English: • The patient should be observed during the infusion and, if clinically indicated, following the infusion (see section 4.4).
Croatian: • Bolesnika je potrebno nadzirati tijekom i, ako je klinički indicirano, nakon infuzije (vidjeti dio
English: The patient should receive at least 3 consecutive infusions of Onpattro without experiencing IRRs before each reduction in corticosteroid premedication.
Croatian: Potrebno je da bolesnik primi najmanje 3 uzastopne infuzije lijeka Onpattro bez pojave reakcija povezanih s infuzijom prije svakog smanjenja premedikacije kortikosteroida.
English: Each vial contains patisiran sodium equivalent to 10 mg patisiran formulated as lipid nanoparticles.
Croatian: Jedna bočica sadrži patisirannatrij u količini koja odgovara 10 mg patisirana, u obliku lipidnih nanočestica.
English: How much Onpattro is given
Croatian: Koliko se lijeka Onpattro daje
English: Your doctor will ensure that your vitamin A levels have returned to normal before you try to become pregnant.
Croatian: A vrati na normalne vrijednosti prije nego što pokušate zatrudnjeti.
English: Onpattro has not been studied in patients with severe renal impairment or end-stage renal disease.
Croatian: Onpattro nije ispitan u bolesnika s teškim oštećenjem funkcije bubrega ni završnim stadijem bubrežne bolesti.
English: If such signs are present, vitamin A supplementation should not exceed 2500 IU per day.
Croatian: A ne smije premašiti 2500 IU dnevno.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Onpattro 2 mg/mL sterile concentrate patisiran
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Onpattro 2 mg/ml sterilni koncentrat patisiran i.v. primjena nakon razrjeđivanja
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).
Croatian: A u serumu od 62 % zabilježena su kroz razdoblje od 18 mjeseci (vidjeti dijelove 4.4 i 4.5).
English: A statistically significant benefit in mNIS+7 with Onpattro relative to placebo was observed at 18 months (Table 2).
Croatian: Statistički značajna korist u rezultatu mNIS+7 zabilježena je u 18. mjesecu uz primjenu lijeka
English: Tél/Tel/Τηλ/ Sími/Tlf/Puh: +31 20 369 7861
Croatian: Tél/Tel/Τηλ/ Sími/Tlf/Puh: +31 203697861 medinfo@alnylam.com
English: NAME OF THE MEDICINAL PRODUCT Onpattro 2 mg/mL concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Onpattro 2 mg/ml koncentrat za otopinu za infuziju.
English: Population pharmacokinetic and pharmacodynamic analyses indicated no impact of mild or moderate renal impairment (eGFR ≥ 30 to < 90 mL/min/1.73m2) on patisiran exposure or TTR reduction compared to subjects with normal renal function.
Croatian: Na temelju populacijskih farmakokinetičkih i farmakodinamičkih analiza utvrđeno je da blago ili umjereno oštećenje funkcije bubrega (eGFR ≥ 30 do < 90 ml/min/1,73m2) nema utjecaja na izloženost patisiranu ili smanjenje proteina TTR u usporedbi s bolesnicima s normalnom funkcijom bubrega.
English: The patient should receive at least 3 consecutive IV infusions of Onpattro without experiencing IRRs before each reduction in corticosteroid premedication.
Croatian: Potrebno je da bolesnik primi najmanje 3 uzastopne i.v. infuzije lijeka Onpattro bez pojave reakcija povezanih s infuzijom prije svakog smanjenja premedikacije kortikosteroida.
English: Intravenous use after dilution.
Croatian: i.v. primjena nakon razrjeđivanja.
English: • Onpattro must be administered through a free-flowing venous access line.
Croatian: • Onpattro se mora primjenjivati kroz cjevčicu za venski pristup neometanog protoka.
English: Tell your doctor or nurse if you notice any of the side effects listed above.
Croatian: Obavijestite svojeg liječnika ili medicinsku sestru ako primijetite bilo koju od prethodno navedenih nuspojava.
English: The estimated patisiran mean ± SD steady-state peak concentration (Cmax), trough concentration (Ctrough), and area under the curve (AUCτ) were 7.15 ± 2.14 µg/mL, 0.021 ± 0.044 µg/mL, and 184 ± 159 µg·h/mL, respectively.
Croatian: Procijenjena srednja vrijednost ± SD vršne koncentracije u stanju dinamičke ravnoteže (Cmax), najniže koncentracije (Ctrough) i površine ispod krivulje (engl. area under the curve, AUCτ) za patisiran bile su 7,15 ± 2,14 µg/ml, 0,021 ± 0,044 µg/ml odnosno 184 ± 159 µg·h/ml.
English: • Patients to inform immediately the HCP if they experience any of the signs and symptoms of IRRs.
Croatian: • potrebi da se bolesnici odmah obrate liječniku ako opaze bilo kakve znakove i simptome reakcija povezanih s infuzijom.
English: Population pharmacokinetic and pharmacodynamic analyses indicated no impact of mild hepatic impairment (bilirubin ≤ 1 x ULN and AST > 1 x ULN, or bilirubin > 1.0 to 1.5 x ULN and any AST) on patisiran exposure or TTR reduction compared to patients with normal hepatic function.
Croatian: Na temelju populacijskih farmakokinetičkih i farmakodinamičkih analiza utvrđeno je da blago oštećenje funkcije jetre (bilirubin ≤ 1 x GGN i AST > 1 x GGN, ili bilirubin > 1,0 do 1,5 x GGN i bilo koja vrijednost AST-a) nema utjecaja na izloženost patisiranu ili smanjenje proteina TTR u usporedbi s bolesnicima s normalnom funkcijom jetre.
English: • Indigestion (dyspepsia)
Croatian: • probavne tegobe (dispepsija)
English: • Discard any unused portion of Onpattro.
Croatian: • Zbrinite neiskorištenu količinu lijeka Onpattro.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Reakcije povezane s infuzijom
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.
Croatian: A ako je ispod donje granice normalnih vrijednosti i procijeniti bilo kakve očne simptome ili znakove nastale zbog nedostatka vitamina A.
English: • Shortness of breath (dyspnoea)
Croatian: • nedostatak zraka (dispneja)
English: The accumulation of AUCτ was 1.76-fold at steady-state compared to the first dose.
Croatian: Akumulacija AUCτ u stanju dinamičke ravnoteže u odnosu na prvu dozu iznosila je 1,76 puta.
English: 10-metre walk test (m/sec)c p < 0.001
Croatian: Test hoda na 10 metara (m/s)c
English: Both too high and too low levels of vitamin A can harm the development of your unborn child.
Croatian: A mogu štetno djelovati na razvoj Vašeg nerođenog djeteta.
English: Secondary Norfolk QoL-DNb
Croatian: Upitnik Norfolk QoL DN
English: Onpattro contains sodium
Croatian: Onpattro sadrži natrij
English: • A dedicated line with an infusion set containing a 1.2 micron PES in-line infusion filter must be used.
Croatian: • Mora se upotrijebiti zasebna infuzijska linija s kompletom za infuziju s ugrađenim filtrom od PES-a s porama od 1,2 mikrona.
English: • Intravenous H1 blocker (diphenhydramine 50 mg, or equivalent)
Croatian: • Intravenski H1 blokator (50 mg difenhidramina ili ekvivalent)
English: There were no significant differences in steady state pharmacokinetic parameters or TTR reduction between patients < 65 years of age and ≥ 65 years of age.
Croatian: Nije bilo značajnih razlika u farmakokinetičkim parametrima u stanju dinamičke ravnoteže ili smanjenju proteina TTR među bolesnicima u dobi
English: • A dedicated line with an infusion set containing a 1.2 micron polyethersulfone (PES) in-line infusion filter must be used.
Croatian: • Mora se upotrijebiti zasebna infuzijska linija s kompletom za infuziju s ugrađenim filtrom od polietersulfona (PES) s porama od 1,2 mikrona.
English: • Signs and symptoms of IRRs;
Croatian: • znakovima i simptomima reakcija povezanih s infuzijom
English: • Each 5 mL vial contains patisiran sodium equivalent to 10 mg patisiran.
Croatian: • Jedna bočica od 5 ml sadrži patisirannatrij u količini koja odgovara 10 mg patisirana.
English: The accumulation of AUCτ was 3.2-fold at steady-state compared to the first dose.
Croatian: Akumulacija AUCτ u stanju dinamičke ravnoteže u odnosu na prvu dozu iznosila je 3,2 puta.