natgillin/translations-raw huggingface dataset:
All patients received premedication with a corticosteroid, paracetamol, and H1 and H2 blockers.
Vse bolnike so premedicirali s kortikosteroidom, paracetamolom ter zaviralci receptorjev H1 in H2.
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.
Norfolški vprašalnik QoL-DN (po navedbah bolnikov) vključuje domene, ki se nanašajo na tanka in debela živčna vlakna in avtonomno delovanje živcev, simptome in aktivnosti vsakodnevnega življenja, s skupnim seštevkom od -4 do 136, pri čemer višji rezultat pomeni slabšanje kakovosti življenja.
Elderly patients No dose adjustment is required in patients ≥ 65 years of age (see section 5.2).
Starejši bolniki Pri bolnikih, starih ≥ 65 let, prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
5 mL concentrate in a Type I glass vial with a chlorobutyl stopper and an aluminium flip-off cap.
5 ml koncentrata v viali iz stekla tipa I s klorobutilnim zamaškom in aluminijasto zaporko.
If you are of childbearing age and intend to use Onpattro, you should practise effective contraception.
Če ste ženska v rodni dobi in nameravate uporabljati zdravilo Onpattro, morate uporabljati učinkovito kontracepcijo.
Onpattro is given as a drip into a vein (called an ‘intravenous infusion').
Zdravilo Onpattro se daje v obliki kapanja v veno (ta proces se imenuje »intravensko infundiranje«).
Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Drugi neželeni učinki Takoj obvestite zdravnika ali medicinsko sestro, če opazite katerega koli od naslednjih neželenih učinkov:
• Onpattro is supplied in cartons containing one vial each.
• Zdravilo Onpattro je na voljo v škatlah, ki vsebujejo po eno vialo.
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.
Če se pojavi reakcija, povezana z infuzijo, je treba razmisliti o upočasnitvi ali prekinitvi infundiranja in uvedbi ustreznega zdravljenja (npr. s kortikosteroidi ali drugo simptomatsko zdravljenje), kot je klinično indicirano.
Intravenous administration of Onpattro had no effect on male reproductive assessments in sexually mature cynomolgus monkeys.
Intravensko dajanje zdravila Onpattro ni vplivalo na oceno sposobnosti razmnoževanja samcev pri spolno zrelih javanskih makakih.
What Onpattro looks like and contents of the pack
Izgled zdravila Onpattro in vsebina pakiranja
• Filter Onpattro through a sterile 0.45 micron polyethersulfone (PES) syringe filter into a sterile container.
• Zdravilo Onpattro filtrirajte skozi sterilni, 0,45-mikronski polietersulfonski (PES) filter v injekcijski brizgi v sterilni vsebnik.
There were no significant differences in steady state pharmacokinetic parameters or TTR reduction between patients < 65 years of age and ≥ 65 years of age.
Pomembnih razlik v farmakokinetičnih parametrih v stanju dinamičnega ravnovesja ali v zmanjšanju TTR pri bolnikih, starih < 65 let in ≥ 65 let, niso ugotovili.
Vitamin A deficiency
Pomanjkanje vitamina A
10-metre walk test (m/sec)c p < 0.001
10-metrski test hoje (m/sek)c p < 0,001
If you miss your dose of Onpattro
Če ste izpustili odmerek zdravila Onpattro
The Onpattro infusion should be discontinued in the case of a serious or life-threatening IRR.
Infundiranje zdravila Onpattro je treba prekiniti v primeru resnih ali smrtno nevarnih reakcij, povezanih z infuzijo.
Onpattro has not been studied in patients with moderate or severe hepatic impairment.
Zdravila Onpattro niso preučili pri bolnikih z zmerno ali hudo okvaro jeter.
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.
To zdravilo vsebuje 3,99 mg natrija na ml, kar je enako 0,2 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča Svetovna zdravstvena organizacija, in znaša 2 g.
• Decrease in night vision, dry eyes, poor vision, hazy or cloudy vision
• poslabšanje nočnega vida, suhe oči, slabovidnost, zamegljen ali nejasen vid.
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)
SN, standardna napaka; povprečje LS, povprečje najmanjših kvadratov; SEM, standardna napaka srednje vrednosti; IZ, interval zaupanja; NIS-W, ocena prizadetosti zaradi nevropatije - podocena šibkosti (motorična zmogljivost); R-ODS, skupna nezmožnost po Rasch-Builtu (sposobnost opravljanja vsakodnevnih dejavnosti po navedbi bolnika); 10-metrski test hoje (hitrost hoje); mBMI, prilagojeni indeks telesne mase (stanje prehranjenosti); COMPASS 31, združena avtonomna ocena simptomov 31 (ocena simptomov po navedbi bolnika).
• The appropriate infusion rate;
• ustrezni hitrosti infundiranja;
Concentrate for solution for infusion (sterile concentrate).
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat).
• Common (≥ 1/100 to < 1/10) • Uncommon (≥ 1/1,000 to < 1/100)
• občasni (≥ 1/1.000 do < 1/100)
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.
V kliničnih študijah, nadzorovanih s placebom, in odprtih kliničnih študijah so se pri 7 od 194 (3,6 %) bolnikov z dedno transtiretinsko amiloidozo med zdravljenjem razvila protitelesa proti zdravilu Onpattro.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so vsi neželeni učinki navedeni po padajoči resnosti.
As a result, during treatment with Onpattro, laboratory tests for serum vitamin A do not reflect the total amount of vitamin A in the body and should not be used to guide vitamin A supplementation (see sections 4.4 and 5.1).
Posledično laboratorijske preiskave ravni vitamina A v serumu med zdravljenjem z zdravilom Onpattro ne kažejo celotne količine vitamina A v telesu, zato se ne smejo uporabljati kot smernice za dodajanje vitamina A (glejte poglavji 4.4 in 5.1).
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.
Po 18 mesecih je bilo prilagojeno razmerje geometrične sredine 0,89 za zdravilo Onpattro in 1,97 za placebo (razmerje 0,45; p < 0,001), kar predstavlja 55-odstotno razliko v korist zdravila Onpattro.
For premedications not available or not tolerated intravenously, equivalents may be administered orally.
Če zdravila za premedikacijo niso na voljo ali jih bolnik po intravenski poti ne prenaša, lahko enakovredna zdravila prejme peroralno.
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).
Ob izhodišču je imelo 46 % bolnikov bolezen 1. stopnje (neprizadeta hoja; običajno blaga senzorična, motorična in avtonomna nevropatija spodnjih udov), 53 % pa jih je imelo bolezen 2. stopnje (potrebna pomoč pri hoji; večinoma zmerno napredovanje prizadetosti spodnjih udov, zgornjih udov in trupa).
hATTR amyloidosis is caused by problems with a protein in the body called ‘transthyretin' (TTR).
Dedno transtiretinsko amiloidozo povzroča težava z beljakovino v telesu, ki se imenuje »transtiretin« (TTR).
• Calculate the required volume of Onpattro based on the recommended weight-based dosage.
• Izračunajte potreben volumen zdravila Onpattro na podlagi priporočenega odmerka na osnovi telesne mase.
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).
V 18-mesečnem obdobju so opazili povprečno zmanjšanje ravni vezavne beljakovine za retinol v serumu za 45 % in vitamina A v serumu za 62 % (glejte poglavji 4.4 in 4.5).
In the event of an unplanned pregnancy, Onpattro should be discontinued (see section 4.6).
V primeru nenačrtovane nosečnosti je treba zdravljenje z zdravilom Onpattro prekiniti (glejte poglavje 4.6).
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.
V 18. mesecu so opazili korist zdravila Onpattro v vseh domenah po norfolškem vprašalniku QoL-DN v primerjavi s placebom in pri 51,4 % bolnikov, zdravljenih z zdravilom Onpattro, se je pokazalo izboljšanje v kakovosti življenja (sprememba po norfolškem vprašalniku o kakovosti življenja pri diabetični nevropatiji (QoL-DN) od izhodišča za < 0 točk) v primerjavi z 10,4 % bolnikov, ki so prejemali placebo.
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.
Ne pričakuje se, da bi na zdravilo Onpattro vplivali zaviralci ali induktorji encimov citokroma P450 ali da bo medsebojno delovalo z drugimi zdravili, razen induciranja in časovno odvisnega zaviranja CYP2B6 in vitro.
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)
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)
In the placebo-controlled study, peripheral oedema was reported in 29.7% of Onpattro-treated patients and 22.1% of placebo-treated patients.
V študiji, nadzorovani s placebom, so o perifernem edemu poročali pri 29,7 % bolnikov, zdravljenih z zdravilom Onpattro, in pri 22,1 % bolnikov, ki so prejemali placebo.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
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.
Intravensko dajanje zdravila Onpattro je povzročilo povečanje jetrnih serumskih markerjev (ALT, AST, alkalna fosfataza in/ali celokupni bilirubin) in histopatoloških izsledkov na jetrih (hepatocelična nekroza/nekroza posamičnih celic, vnetje, odlaganje pigmenta in/ali monocitna infiltracija) pri odmerkih > 100 mikrogramov na kg vsake 4 tedne pri podganah in pri odmerkih > 1,0 mg/kg vsake 3 tedne pri opicah.
The accumulation of AUCτ was 1.76-fold at steady-state compared to the first dose.
Kopičenje AUCτ je bilo 1,76-kratno v stanju dinamičnega ravnovesja v primerjavi s prvim odmerkom.
You should not use Onpattro if you are pregnant, unless advised by your doctor.
Če ste noseči, zdravila Onpattro ne smete jemati, razen če vam to svetuje zdravnik.
At the dose regimen of 300 micrograms per kg every 3 weeks, steady state was reached by 24 weeks of treatment.
Z režimom odmerjanja 300 mikrogramov na kg vsake 3 tedne je bilo stanje dinamičnega ravnovesja doseženo do 24. tedna zdravljenja.
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.
Ravni vitamina A v serumu, ki so pod spodnjo mejo normalnih vrednosti, je treba korigirati in pred uvedbo zdravljenja z zdravilom Onpattro oceniti kakršne koli očesne simptome ali znake zaradi pomanjkanja vitamina A.
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).
Zdravila Onpattro niso preučili pri bolnikih z zmerno ali hudo okvaro jeter in ga ti bolniki ne smejo prejemati, razen če pričakovana klinična korist odtehta možno tveganje (glejte poglavje 5.2).
Onpattro is a white to off-white, opalescent, homogeneous solution.
Zdravilo Onpattro je bela do belkasta, opalescentna, homogena raztopina.
• Chest discomfort or chest pain
• nelagodje ali bolečina v prsnem košu
There were no adverse effects on the pups.
Neželenih učinkov na dojene mladiče niso opazili.
Your doctor will ask you to take a daily vitamin A supplement during treatment with Onpattro.
Zdravnik vam bo naročil, da v času zdravljenja z zdravilom Onpattro vsak dan vzamete dodatek vitamina A.
Tell your doctor or nurse straight away if you get any signs of an infusion-related reaction.
Zdravniku ali medicinski sestri takoj povejte, če opazite kakršne koli znake reakcij, povezanih z infuzijo.
Close monitoring of the foetus should be carried out in the event of an unplanned pregnancy, especially during the first trimester (see section 4.4).
V primeru nenačrtovane nosečnosti je treba skrbno spremljati plod, zlasti v prvem trimesečju (glejte poglavje 4.4).
Name and address of the manufacturer(s) responsible for batch release
SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Zdravilo Onpattro je indicirano za zdravljenje dedne transtiretinske amiloidoze pri odraslih bolnikih s polinevropatijo 1. ali 2 stopnje.
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.
Simptomi reakcij, povezanih z infuzijo, med drugim vključujejo: artralgijo ali bolečino (vključno z bolečino v hrbtu, vratu ali mišično-skeletno bolečino), zardevanje (vključno z eritemom obraza ali toploto na koži), navzeo, bolečino v trebuhu, dispnejo ali kašelj, nelagodje ali bolečino v prsnem košu, glavobol, izpuščaj, mrzlico, omotico, utrujenost, povečan srčni utrip ali palpitacije, hipotenzijo, hipertenzijo in edem obraza.
In clinical studies, all patients received premedication with a corticosteroid, paracetamol, and H1 and H2 blockers to reduce the risk of IRRs.
V kliničnih študijah so vse bolnike premedicirali s kortikosteroidom, paracetamolom in zaviralci histaminskih receptorjev H1 in H2 za zmanjšanje tveganja reakcij, povezanih z infuzijo.
• The usual dose of Onpattro is 300 micrograms per kilogram (kg) of body weight given once every
• Običajni odmerek zdravila Onpattro je 300 mikrogramov na kilogram (kg) telesne mase, ki se daje vsake 3 tedne.
Anti-drug antibodies to Onpattro were evaluated by measuring antibodies specific to PEG2000-C-DMG, a lipid component exposed on the surface of Onpattro.
Protitelesa proti zdravilu Onpattro so ocenili z merjenjem protiteles, specifičnih za PEG2000-C-DMG, lipidno komponento, izpostavljeno na površini zdravila Onpattro.
Onpattro did not exhibit a genotoxic potential in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice.
Zdravilo Onpattro pri transgenih miših RasH2 ni pokazalo genotoksičnega potenciala in vitro in in vivo ter ni bilo kancerogeno.
Across clinical studies, the most common symptoms (reported in ≥ 2% of patients) of IRRs were flushing, back pain, nausea, abdominal pain, dyspnoea, and headache.
Najpogostejši simptomi reakcij, povezanih z infuzijo, o katerih so poročali v vseh kliničnih študijah (pri ≥ 2 % bolnikov) so bili zardevanje, bolečina v hrbtu, navzea, bolečina v trebuhu, dispneja in glavobol.
• Steps to consider to prevent further IRRs;
• korakih, ki jih je treba upoštevati za preprečevanje reakcij, povezanih z infuzijo;
Pregnancy should be excluded before starting treatment with Onpattro.
Pred začetkom zdravljenja z zdravilom Onpattro je treba izključiti nosečnost.
Marketing Authorisation Holder Alnylam Netherlands B.V.
Imetnik dovoljenja za promet z zdravilom Alnylam Netherlands B.V.
• Redness of the skin (erythema)
• rdečina kože (eritem)
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.
Spremembe so opazili tudi v 9. mesecu, ob prvi oceni v študiji po izhodišču, kjer je zdravljenje z zdravilom Onpattro privedlo do razlike v zdravljenju za 16,0 točk,
Mean serum TTR was reduced by approximately 80% within 10 to 14 days after a single dose with 300 micrograms per kg Onpattro.
Povprečna raven TTR v serumu se je v 10 do 14 dneh po enkratnem odmerku 300 mikrogramov zdravila Onpattro na kilogram zmanjšala za približno 80 %.
Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during treatment.
Zdravniku ali medicinski sestri takoj povejte, če se vam med zdravljenjem pojavi kateri od naslednjih znakov reakcije, povezane z infuzijo.
Vitamin A testing
Preiskave vitamina A
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.
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.
• Swelling of the face
• otekanje obraza
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.
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.
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:
Na dan infundiranja zdravila Onpattro je treba bolniku vsaj 60 minut pred začetkom infundiranja dati vsako od naslednjih zdravil:
Serum TTR is a carrier of retinol binding protein, which facilitates transport of vitamin A in the blood.
TTR v serumu je nosilec vezavne beljakovine za retinol, ki olajša prenos vitamina A v krvi.
• 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).
• 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).
Your healthcare professional will throw away any medicines that are no longer being used.
Zdravilo, ki ga ne uporabljate več, bo zavrgel zdravstveni delavec.
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).
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).
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).
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).
If refrigeration is not available, Onpattro can be stored at room temperature up to 25°C for up to 14 days.
Če zdravila Onpattro ni možno shraniti v hladilnik, ga lahko do 14 dni shranjujete pri sobni temperaturi do 25 °C.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains patisiran sodium equivalent to 2 mg patisiran.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml vsebuje natrijev patisiranat v količini, ki ustreza 2 mg patisirana.
• Onpattro is a white to off-white, opalescent, homogeneous concentrate for solution for infusion.
• Zdravilo Onpattro je bel do belkast, opalescenten, homogen koncentrat za raztopino za infundiranje.
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).
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).
Liver transplant
Presaditev jeter
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.
Pred vsakim infundiranjem zdravila Onpattro boste prejeli zdravila, ki pomagajo zmanjšati tveganje reakcij, povezanih z infuzijo.
In rats and monkeys, PEG2000-C-DMG is eliminated unchanged in the bile.
Pri podganah in opicah se je lipidna komponenta PEG2000-C-DMG v nespremenjeni obliki izločila v žolču.
• Onpattro must be diluted prior to intravenous infusion.
• Zdravilo Onpattro je treba pred intravenskim infundiranjem razredčiti.
The infusion site should be monitored for possible infiltration during administration.
Mesto infundiranja je treba med infundiranjem zdravila spremljati zaradi morebitne infiltracije.
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.
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.
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).
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).
Few IRRs led to infusion interruption.
Nekaj reakcij, povezanih z infuzijo, je vodilo v prekinitev infundiranja.