FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during treatment.
Slovenian: Zdravniku ali medicinski sestri takoj povejte, če se vam med zdravljenjem pojavi kateri od naslednjih znakov reakcije, povezane z infuzijo.
English: Vitamin A testing
Slovenian: Preiskave vitamina A
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.
Slovenian: Vrednost N-končnega natriuretičnega propeptida tipa B (NT-proBNP - N-terminal pro-B-type natriuretic peptide) ob izhodišču je bila 727 ng/l (geometrična sredina) pri bolnikih, zdravljenih z zdravilom Onpattro, in 711 ng/l (geometrična sredina) pri bolnikih, ki so prejemali placebo.
English: • Swelling of the face
Slovenian: • otekanje obraza
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.
Slovenian: V prvem trimesečju vam zdravnik lahko naroči, da prenehate jemati dodatek vitamina A. Zadnjih 6 mesecev nosečnosti morate nadaljevati z jemanjem dodatka vitamina A, če se ravni vitamina A v krvi še niso vrnile na normalno vrednost, saj obstaja povečano tveganje pomanjkanja vitamina A v zadnjih 3 mesecih nosečnosti.
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:
Slovenian: Na dan infundiranja zdravila Onpattro je treba bolniku vsaj 60 minut pred začetkom infundiranja dati vsako od naslednjih zdravil:
English: Serum TTR is a carrier of retinol binding protein, which facilitates transport of vitamin A in the blood.
Slovenian: TTR v serumu je nosilec vezavne beljakovine za retinol, ki olajša prenos vitamina A v krvi.
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).
Slovenian: • Druge sestavine zdravila so 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]karbonilamino}propil)-ω-metoksi, polioksietilen), DSPC (1,2-distearoil-sn-glicero-3-fosfoholin), holesterol, natrijev hidrogenfosfat heptahidrat, brezvodni kalijev dihidrogenfosfat, natrijev klorid in voda za injekcije (glejte »Zdravilo Onpattro vsebuje natrij« v poglavju 2).
English: Your healthcare professional will throw away any medicines that are no longer being used.
Slovenian: Zdravilo, ki ga ne uporabljate več, bo zavrgel zdravstveni delavec.
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).
Slovenian: Pri analizi mejnih vrednosti mNIS+7 (sprememba od izhodišča za < 0 točk) se je pri 56,1 % bolnikov, zdravljenih z zdravilom Onpattro, pokazalo izboljšanje v mNIS+7, v primerjavi z 3,9 % bolnikov, ki so prejemali placebo (p < 0,001).
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).
Slovenian: Pri podganjih samicah v laktaciji patisiran ni bil prisoten v mleku, vendar pa so bile v njem prisotne majhne količine lipidnih komponent DLin-MC3-DMA in PEG2000-C-DMG (do 7 % sočasnih koncentracij v plazmi matere).
English: If refrigeration is not available, Onpattro can be stored at room temperature up to 25°C for up to 14 days.
Slovenian: Če zdravila Onpattro ni možno shraniti v hladilnik, ga lahko do 14 dni shranjujete pri sobni temperaturi do 25 °C.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml vsebuje natrijev patisiranat v količini, ki ustreza 2 mg patisirana.
English: • Onpattro is a white to off-white, opalescent, homogeneous concentrate for solution for infusion.
Slovenian: • Zdravilo Onpattro je bel do belkast, opalescenten, homogen koncentrat za raztopino za infundiranje.
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).
Slovenian: Razpoložljivi toksikološki podatki pri živalih so pokazali izločanje majhnih količin lipidnih komponent DLin-MC3-DMA in PEG2000-C-DMG v mleko (glejte poglavje 5.3).
English: Liver transplant
Slovenian: Presaditev jeter
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.
Slovenian: Pred vsakim infundiranjem zdravila Onpattro boste prejeli zdravila, ki pomagajo zmanjšati tveganje reakcij, povezanih z infuzijo.
English: In rats and monkeys, PEG2000-C-DMG is eliminated unchanged in the bile.
Slovenian: Pri podganah in opicah se je lipidna komponenta PEG2000-C-DMG v nespremenjeni obliki izločila v žolču.
English: • Onpattro must be diluted prior to intravenous infusion.
Slovenian: • Zdravilo Onpattro je treba pred intravenskim infundiranjem razredčiti.
English: The infusion site should be monitored for possible infiltration during administration.
Slovenian: Mesto infundiranja je treba med infundiranjem zdravila spremljati zaradi morebitne infiltracije.
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.
Slovenian: Zdravnik vam bo izmeril ravni vitamina A in če bojo te prenizke, jih bo treba vrniti na normalno raven in odpraviti simptome zaradi pomanjkanja vitamina A, preden boste lahko začeli z zdravljenjem z zdravilom Onpattro.
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).
Slovenian: Zdravila Onpattro niso preučili pri bolnikih s hudo ledvično okvaro ali končno odpovedjo ledvic in ga ti bolniki ne smejo prejemati, razen če pričakovana klinična korist odtehta možno tveganje (glejte poglavje 5.2).
English: Few IRRs led to infusion interruption.
Slovenian: Nekaj reakcij, povezanih z infuzijo, je vodilo v prekinitev infundiranja.
English: Primary mNIS+7b
Slovenian: Primarni mNIS+7b p < 0,001
English: How much Onpattro is given
Slovenian: Koliko zdravila Onpattro boste prejeli
English: The accumulation of AUCτ was 3.2-fold at steady-state compared to the first dose.
Slovenian: Kopičenje AUCτ je bilo 3,2-kratno v stanju dinamičnega ravnovesja v primerjavi s prvim odmerkom.
English: By reducing serum TTR protein, Onpattro treatment leads to a decrease in serum vitamin A (retinol) levels (see section 5.1).
Slovenian: Zdravilo Onpattro z zmanjšanjem ravni beljakovine TTR v serumu povzroči zmanjšanje ravni vitamina A (retinol) v serumu (glejte poglavje 5.1).
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).
Slovenian: V kliničnih študijah niso ugotovili pomembnih razlik v farmakokinetičnih parametrih ali zmanjšanju TTR v stanju dinamičnega ravnovesja glede na spol ali raso (nebelci v primerjavi z belci).
English: If the infusion is interrupted, resumption of the infusion at a slower infusion rate may be considered after symptoms have resolved.
Slovenian: Pri prekinitvi infundiranja se infundiranje lahko ponovno začne z nižjo hitrostjo, ko simptomi izzvenijo.
English: Treatment with Onpattro reduces serum TTR levels, which results in reduced levels of retinol binding protein and vitamin A in the serum.
Slovenian: Zdravljenje z zdravilom Onpattro zmanjša ravni TTR v serumu, kar povzroči zmanjšanje ravni vezavne beljakovine za retinol in vitamina A v serumu.
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.
Slovenian: Znaki in simptomi so vključevali flebitis ali tromboflebitis, otekanje na mestu infundiranja ali injiciranja, dermatitis (subkutano vnetje), celulitis, eritem ali rdečino na mestu injiciranja, pekoč občutek ali bolečino na mestu injiciranja.
English: Each mL contains 2 mg patisiran.
Slovenian: En ml vsebuje 2 mg patisirana.
English: • Pain, redness, burning sensation, or swelling at or near the infusion site
Slovenian: • bolečina, rdečina, pekoč občutek ali oteklina na mestu infundiranja ali okoli njega
English: A97S (9%), T60A (7%), E89Q (6%), and S50R (5%).
Slovenian: Zastopanih je bilo devetintrideset (39) različnih mutacij TTR; najpogostejše (≥ 5 %) so bile V30M (43 %), A97S (9 %), T60A (7 %), E89Q (6 %) in S50R (5 %).
English: Treatment with Onpattro lowers the amount of vitamin A in your blood.
Slovenian: Zdravljenje z zdravilom Onpattro zmanjšuje količino vitamina A v vaši krvi.
English: • Intravenous corticosteroid (dexamethasone 10 mg, or equivalent)
Slovenian: • intravenski kortikosteroid (deksametazon 10 mg ali enakovredno zdravilo)
English: If you are a woman of child-bearing age, you should practice effective contraception during treatment with Onpattro.
Slovenian: Če ste ženska v rodni dobi, morate uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Onpattro.
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.
Slovenian: Populacijske farmakokinetične in farmakodinamične analize niso pokazale vpliva blage ali zmerne okvare ledvic (eGFR ≥ 30 do < 90 ml/min/1,73m2) na izpostavljenost patisiranu ali zmanjšanje TTR v primerjavi z osebami z normalnim delovanjem ledvic.
English: The primary efficacy endpoint was the change from baseline to 18 months in modified Neuropathy Impairment Score +7 (mNIS+7).
Slovenian: Primarni opazovani dogodek učinkovitosti je bila sprememba v modificirani lestvici nevropatske okvare (mNIS+7) od izhodišča do 18 mesecev.
English: All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs) (see section 4.4).
Slovenian: Vsi bolniki morajo pred infundiranjem zdravila Onpattro prejeti premedikacijo za zmanjšanje tveganja reakcij, povezanih z infuzijo (glejte poglavje 4.4).
English: The key secondary endpoint was the change from baseline to 18 months in Norfolk Quality of LifeDiabetic Neuropathy (QoL-DN) total score.
Slovenian: Ključni sekundarni opazovani dogodek je bila sprememba v skupnem seštevku po norfolškem vprašalniku o kakovosti življenja pri diabetični nevropatiji (QoL-DN - Norfolk Quality of LifeDiabetic Neuropathy) od izhodišča do 18 mesecev.
English: For clinical management of IRRs, see section 4.4.
Slovenian: Za klinično obravnavo reakcij, povezanih z infuzijo, glejte poglavje 4.4.
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.
Slovenian: Pri nekaterih bolnikih, ki imajo reakcije, povezane z infuzijo, lahko upočasnitev hitrosti infundiranja ali dodatni oz. večji odmerki enega ali več zdravil za premedikacijo pri nadaljnjih infuzijah pomagajo zmanjšati tveganje reakcij, povezanih z infuzijo.
English: • Patients to inform immediately the HCP if they experience any of the signs and symptoms of IRRs.
Slovenian: • obveznosti bolnikov, da morajo zdravstvenega delavca takoj obvestiti, če se jim pojavijo znaki in simptomi reakcij, povezanih z infuzijo.
English: • Discard any unused portion of Onpattro.
Slovenian: • Neuporabljeni del zdravila Onpattro zavrzite.
English: A statistically significant benefit in mNIS+7 with Onpattro relative to placebo was observed at 18 months (Table 2).
Slovenian: Statistično značilno korist v mNIS+7 pri bolnikih, zdravljenih z zdravilom Onpattro, v primerjavi s placebom so opazili v 18. mesecu (preglednica 2).
English: Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis.
Slovenian: Zdravljenje mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju bolnikov z amiloidozo.
English: The frequency of IRRs decreased over time.
Slovenian: Pogostnost reakcij, povezanih z infuzijo, se je sčasoma zmanjševala.
English: • Stuffy or runny nose (rhinitis)
Slovenian: • zamašen nos ali izcedek iz nosu (rinitis)
English: In Onpattro-treated patients, all IRRs were either mild (95.2%) or moderate (4.8%) in severity.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Onpattro, so bile vse reakcije, povezane z infuzijo, blage (95,2 %) ali zmerne (4,8 %).
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.
Slovenian: Farmakokinetične lastnosti zdravila Onpattro so bile določene z merjenjem koncentracij patisirana v plazmi in lipidnih komponent DLin-MC3-DMA in PEG2000-C-DMG.
English: If refrigeration is not available, Onpattro can be stored at room temperature (up to 25°C) for up to 14 days.
Slovenian: Če zdravila Onpattro ni možno shraniti v hladilnik, ga lahko do 14 dni shranjujete pri sobni temperaturi (do 25 °C).
English: In patients experiencing an IRR, the majority experienced the first IRR within the first 2 infusions (see section 4.8).
Slovenian: Pri bolnikih, ki imajo reakcije, povezane z infuzijo, se prva reakcija, povezana z infuzijo, običajno pojavi pri prvih 2 infuzijah (glejte poglavje 4.8).
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.
Slovenian: Z režimom odmerjanja 300 mikrogramov na kg vsake 3 tedne je bil povprečni volumen porazdelitve (Vss) ± SN v stanju dinamičnega ravnovesja za patisiran, DLin-MC3-DMA in PEG2000-C-DMG 0,26 ± 0,20 l/kg, 0,47 ± 0,24 l/kg oz. 0,13 ± 0,05 l/kg.
English: In the double-blind placebo-controlled study, 18.9% of Onpattro-treated patients experienced IRRs, compared to 9.1% of placebo-treated patients.
Slovenian: V dvojno slepi, s placebom nadzorovani študiji, je 18,9 % bolnikov, zdravljenih z zdravilom Onpattro, imelo reakcije, povezane z infuzijo, v primerjavi z 9,1 % bolnikov, ki so prejemali placebo.
English: The duration of infusion may be extended in the event of an IRR (see section 4.4).
Slovenian: V primeru reakcije, povezane z infuzijo, je možno trajanje infundiranja podaljšati (glejte poglavje 4.4).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
English: Women of childbearing potential have to use effective contraception during treatment with Onpattro.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Onpattro uporabljati učinkovito kontracepcijo.
English: Therefore, pregnancy should be excluded before initiation of treatment and women of childbearing potential should use effective contraception.
Slovenian: Zato je treba pred uvedbo zdravljenja izključiti nosečnost, ženske v rodni dobi pa morajo uporabljati učinkovito kontracepcijo.
English: IRRs resulted in permanent discontinuation of Onpattro in < 1% of patients in clinical studies.
Slovenian: V kliničnih študijah so zdravljenje z zdravilom Onpattro zaradi reakcij, povezanih z infuzijo, trajno prekinili pri < 1 % bolnikov.
English: Onpattro is a medicine that treats an illness which runs in families called hereditary ATTR (hATTR) amyloidosis.
Slovenian: Zdravilo Onpattro se uporablja za zdravljenje bolezni, ki se prenaša v družini, in se imenuje dedna transtiretinska amiloidoza.
English: If you miss an appointment to have Onpattro, ask your doctor or nurse when to book your next treatment.
Slovenian: Če izpustite obisk za dajanje zdravila Onpattro, se z zdravnikom ali medicinsko sestro dogovorite za naslednji termin za prejem zdravljenja.
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.
Slovenian: • Po končanem infundiranju je treba intravenski komplet za infundiranje splakniti z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml), s čimer zagotovite, da je bolnik prejel celoten odmerek zdravila.
English: Vitamin A supplementation at approximately 2500 IU vitamin A per day is advised for patients treated with Onpattro (see section 4.4).
Slovenian: Pri bolnikih, ki prejemajo zdravilo Onpattro, se svetuje dodajanje vitamina A v odmerku približno 2.500 i.e. na dan (glejte poglavje 4.4).
English: Onpattro has not been studied in patients with severe renal impairment or end-stage renal disease.
Slovenian: Zdravila Onpattro niso preučili pri bolnikih s hudo ledvično okvaro ali končno odpovedjo ledvic.
English: • Each 5 mL vial contains patisiran sodium equivalent to 10 mg patisiran.
Slovenian: • Ena 5 ml viala vsebuje natrijev patisiranat, ki ustreza 10 mg patisirana.
English: • Signs and symptoms of IRRs;
Slovenian: • znakih in simptomih reakcij, povezanih z infuzijo;
English: • A dedicated line with an infusion set containing a 1.2 micron PES in-line infusion filter must be used.
Slovenian: • Uporabiti je treba namensko linijo z infuzijskim kompletom, ki vsebuje 1,2-mikronski linijski filter za infundiranje iz PES.
English: No impact on male or female fertility was detected in animal studies (see section 5.3).
Slovenian: Študije na živalih niso pokazale vpliva na plodnost samcev ali samic (glejte poglavje 5.3).
English: There was no accumulation of AUCτ at steady-state compared to the first dose.
Slovenian: Kopičenja AUCτ v stanju dinamičnega ravnovesja v primerjavi s prvim odmerkom ni bilo.
English: Additional or higher doses of one or more of the premedications may be administered to reduce the risk of IRRs, if needed.
Slovenian: Po potrebi se lahko daje dodatne ali večje odmerke enega ali več zdravil za premedikacijo, da se zmanjša tveganje reakcij, povezanih z infuzijo.
English: Do not use if discolouration or foreign particles are present.
Slovenian: Zdravila ne uporabite, če je spremenjene barve ali so v njem tujki.
English: • Onpattro must be administered through a secure and free-flowing venous access line.
Slovenian: • Zdravilo Onpattro je treba infundirati skozi zavarovano, stalno linijo venskega dostopa.
English: Serum vitamin A levels should not be used to guide vitamin A supplementation during treatment with Onpattro (see section 4.5).
Slovenian: Ravni vitamina A v serumu se v času zdravljenja z zdravilom Onpattro ne smejo uporabljati kot smernice za dodajanje vitamina A (glejte poglavje 4.5).
English: However, transport and tissue uptake of vitamin A can occur through alternative mechanisms in the absence of retinol binding protein.
Slovenian: Vendar pa lahko v odsotnosti vezavne beljakovine za retinol prenos in privzem vitamina A v tkivo potekata s pomočjo alternativnih mehanizmov.
English: white to off-white coating may be observed on the inner surface of the vial, typically at the liquid-headspace interface.
Slovenian: Na notranji površini viale je možno opaziti belo do belkasto oblogo, običajno v prostoru med tekočino in parno fazo.
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.
Slovenian: Pri podganah so v beli pulpi vranice opazili limfoidno atrofijo/nekrozo in histiocitozo, pri opicah pa hipocelularnost v rdeči pulpi.
English: In the placebo-controlled study, 62 (41.9%) patients treated with Onpattro were ≥ 65 years of age and
Slovenian: V študiji, nadzorovani s placebom, je bilo 62 (41,9 %) bolnikov, zdravljenih z zdravilom Onpattro, starih ≥ 65 let, 9 (6,1 %) bolnikov pa je bilo starih ≥ 75 let.
English: The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class (SOC) by frequency.
Slovenian: Neželeni učinki so predstavljeni po prednostnih izrazih po MedDRA in organskih sistemih po MedDRA po pogostnosti.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja pogosti
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Patients receiving Onpattro should take oral supplementation of approximately 2500 IU vitamin A per day to reduce the potential risk of ocular toxicity due to vitamin A deficiency.
Slovenian: Bolniki, ki prejemajo zdravilo Onpattro, morajo za zmanjšanje možnega tveganja toksičnosti za oči zaradi pomanjkanja vitamina A peroralno jemati nadomestek vitamina A v odmerku 2.500 i.e na dan.
English: Onpattro 2 mg/mL concentrate for solution for infusion patisiran
Slovenian: Onpattro 2 mg/ml koncentrat za raztopino za infundiranje patisiran
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.
Slovenian: Če je klinično indicirano, je možno odmerek kortikosteroida postopoma zmanjševati v korakih po največ 2,5 mg do najmanjšega odmerka 5 mg deksametazona (intravensko, i.v.)
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.
Slovenian: Z režimom odmerjanja 300 mikrogramov na kg vsake 3 tedne je bil povprečni plazemski očistek patisirana v stanju dinamičnega ravnovesja ± SN (CLss) 3,0 ± 2,5 ml/h/kg.
English: 3 weeks.
Slovenian: infuzije vsake 3 tedne.
English: Onpattro contains sodium
Slovenian: Zdravilo Onpattro vsebuje natrij
English: Onpattro works by lowering the amount of TTR protein that the liver makes.
Slovenian: Zdravilo Onpattro učinkuje tako, da zmanjšuje količino beljakovine TTR, ki nastaja v jetrih.
English: • A dedicated line with an infusion set containing a 1.2 micron polyethersulfone (PES) in-line infusion filter must be used.
Slovenian: • Uporabiti je treba namensko linijo z infuzijskim kompletom, ki vsebuje 1,2-mikronski linijski filter za infundiranje iz polietersulfona (PES).
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.
Slovenian: Če je klinično indicirano, je možno odmerek kortikosteroida postopoma zmanjševati v korakih po največ 2,5 mg do najmanjšega odmerka 5 mg deksametazona (i.v.)
English: Therefore, pregnancy should be excluded before initiating Onpattro and women of childbearing potential should practise effective contraception.
Slovenian: Zato je treba pred začetkom jemanja zdravila Onpattro izključiti nosečnost, ženske v rodni dobi pa morajo uporabljati učinkovito kontracepcijo.