natgillin/translations-raw huggingface dataset:
No data are available for patients weighing ≥ 110 kg.
Podatkov za bolnike s telesno maso ≥ 110 kg ni na voljo.
Prior to the launch of Onpattro in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Pred prihodom zdravila Onpattro na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnih gradiv, vključno s komunikacijskimi sredstvi, načini razdeljevanja in drugimi vidiki programa.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and given symptomatic treatment, as appropriate.
V primeru prevelikega odmerjanja je bolnika priporočljivo spremljati glede znakov ali simptomov neželenih učinkov in ga po potrebi simptomatsko zdraviti.
There are no data on the effects of Onpattro on human fertility.
Podatkov o učinku zdravila Onpattro na plodnost pri človeku ni.
• Action to take in the event of an IRRs and in case of emergency;
• ukrepanju v primeru pojava reakcij, povezanih z infuzijo, in v nujnih primerih;
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
These include anti-histamines, a corticosteroid (a medicine that suppresses inflammation), and a pain reliever.
Ta vključujejo antihistaminike, kortikosteroid (zdravilo, ki zavira vnetje) in zdravilo za lajšanje bolečin.
Do not mix or dilute with other medicinal products.
Zdravila ne mešajte in ne redčite z drugimi zdravili.
Suspected extravasation should be managed according to local standard practice for non-vesicants.
Pri sumu na ekstravazacijo je treba ravnati v skladu z lokalno ustaljeno prakso za učinkovine, ki niso mehurjevci.
Therefore, women of child-bearing age should not be pregnant when starting treatment with Onpattro and should practice effective contraception (see section “Pregnancy, breast-feeding and contraception” below).
Ženske v rodni dobi zato ne smejo biti noseče, ko se začnejo zdraviti z zdravilom Onpattro, in morajo uporabljati učinkovito kontracepcijo (glejte poglavje »Nosečnost, dojenje in kontracepcija« spodaj).
• Onpattro will be given to you by a doctor or nurse.
• Zdravilo Onpattro vam bo dal zdravnik ali medicinska sestra.
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.
V prvih 60 dneh nosečnosti so lahko previsoke ali prenizke ravni vitamina A povezane s povečanim tveganjem malformacije ploda.
Severe hypersensitivity (e.g., anaphylaxis) to the active substance or any of the excipients listed in section 6.1.
Huda preobčutljivost (npr. anafilaksa) na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
• 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.
• Razredčeno raztopino zdravila Onpattro se infundira intravensko v približno 80-minutnem obdobju z začetno hitrostjo infundiranja približno 1 ml/min prvih 15 minut, nato pa se jo poveča na približno 3 ml/min za preostali čas infundiranja.
The safety and efficacy of Onpattro in children or adolescents < 18 years of age have not been established.
Varnost in učinkovitost zdravila Onpattro pri otrocih ali mladostnikih, mlajših od 18 let, nista bili dokazani.
Less than 1% of patisiran in the administered dose was recovered intact in urine.
Manj kot 1 % patisirana iz danega odmerka je bilo v nespremenjeni obliki izoliranega v urinu.
The infusion may need to be slowed down or stopped, and you may need to take other medicines to manage the reaction.
Morda bo treba infundiranje upočasniti ali ustaviti, vi pa boste morda morali vzeti druga zdravila za zdravljenje reakcije.
Patisiran is not a substrate of cytochrome P450 enzymes.
Patisiran ni substrat encimov citokroma P450.
Your doctor may tell you to stop taking Onpattro.
Zdravnik vam bo morda naročil, da prenehate jemati zdravilo Onpattro.
For storage conditions after dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
dmBMI: body mass index (BMI; kg/m2) multiplied by serum albumin (g/L); a higher number indicates better nutritional status; nutritional status favoured Onpattro as early as 3 months.
dmBMI: indeks telesne mase (BMI; kg/m2) pomnožen z vrednostjo albumina v serumu (g/l); večja številka pomeni boljše stanje prehranjenosti; zdravilo Onpattro je izboljšalo stanje prehranjenosti že v 3. mesecu.
Approximately half (53%) of patients had prior treatment with tafamidis meglumine or diflunisal.
Približno polovica (53 %) bolnikov se je pred tem zdravila s tafamidis megluminom ali diflunisalom.
The European Medicines Agency has waived the obligation to submit the results of studies with Onpattro in all subsets of the paediatric population in hATTR amyloidosis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Onpattro za vse podskupine pediatrične populacije pri dedni transtiretinski amiloidozi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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%).
Demografske in izhodiščne značilnosti med skupinama zdravljenja so bile uravnotežene, z izjemo dejstva, da je imel večji delež bolnikov v skupini z zdravilom Onpattro mutacijo, ki ni bila V30M (62 % v primerjavi z 48 %).
As patisiran is not pharmacologically active in rabbits, these effects are not due to reductions in TTR, thyroxine or vitamin A.
Ker patisiran pri kuncih ni farmakološko aktiven, ti učinki niso posledica zmanjšanja ravni TTR, tiroksina ali vitamina A.
• Irritation or infection of the airways (sinusitis, bronchitis)
• draženje ali okužba dihal (sinusitis, bronhitis)
Other medicines and Onpattro
Druga zdravila in zdravilo Onpattro
cA higher number indicates less disability/less impairment.
cVečja številka pomeni manjšo nezmožnost/manjšo prizadetost.
Alnylam UK Ltd.
United Kingdom Alnylam UK Ltd.
This medicine contains 3.99 milligrams (mg) of sodium (main component of cooking/table salt) per millilitre (mL).
To zdravilo vsebuje 3,99 miligramov (mg) natrija (glavne sestavine kuhinjske soli) na mililiter (ml).
Each mL of concentrate contains 3.99 mg sodium.
En ml koncentrata vsebuje 3,99 mg natrija.
Home infusions should be performed by a healthcare professional.
Infundiranje zdravila doma mora izvajati zdravstveni delavec.
• Feeling tired (fatigue)
• občutek utrujenosti (utrujenost)
Very common: may affect more than 1 in 10 people • Swelling of the arms or legs (peripheral oedema)
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov • otekanje rok ali nog (periferni edem)
The only adverse reaction resulting in the discontinuation of Onpattro was an infusion-related reaction (0.7%).
Edini neželen učinek, zaradi katerega so zdravljenje z zdravilom Onpattro prekinili, je bila reakcija, povezana z infuzijo (0,7 %).
With repeat dosing every 3 weeks, mean reductions of serum TTR after 9 and 18 months of treatment were 83% and 84%, respectively.
S ponavljajočim odmerjanjem vsake 3 tedne je bilo povprečno zmanjšanje ravni TTR v serumu po 9 mesecih zdravljenja 83 % in po 18 mesecih zdravljenja 84 %.
Patients were randomised 2:1 to receive 300 micrograms per kg Onpattro or placebo via intravenous infusion once every 3 weeks for 18 months.
Bolnike so randomizirali v razmerju 2:1 na prejemanje 300 mikrogramov na kg zdravila Onpattro ali placeba v intravenski infuziji vsake 3 tedne v obdobju 18 mesecev.
Before each infusion you will be given medicines that help to lower the chance of infusion-related reactions (see “Medicines given during treatment with Onpattro” in section 3).
Pred vsako infuzijo boste prejeli zdravila, ki pomagajo zmanjšati možnosti za reakcije, povezane z infuzijo (glejte »Zdravila, ki se dajejo med zdravljenjem z zdravilom Onpattro« v poglavju 3).
Onpattro Placebo
Zdravilo Onpattro Placebo
Forty-nine percent (49%) and 50% of patients had a New York Heart Association (NYHA) Class of I or II, respectively.
Devetinštirideset odstotkov (49 %) bolnikov je bilo uvrščenih v I. razred po funkcijski razvrstitvi Newyorškega združenja za srce (NYHA - New York Heart Association), 50 % pa v II.
• If Onpattro is administered more than 3 days after the missed dose, dosing should be continued every 3 weeks thereafter.
• Če bolnik zdravilo Onpattro prejme več kot 3 dni po izpuščenem odmerku, naj se odmerjanje nadaljuje vsake 3 tedne po tem dnevu.
The educational material for HCPs should include information about:
Izobraževalno gradivo za zdravstvene delavce mora vsebovati informacije o:
If you are given more Onpattro than you should receive This medicine will be given to you by your doctor or nurse.
Če ste prejeli večji odmerek zdravila Onpattro, kot bi smeli To zdravilo vam bo dal zdravnik ali medicinska sestra.
• Onpattro must be diluted prior to intravenous infusion (see instructions in section 6.6).
• Zdravilo Onpattro je treba pred intravenskim infundiranjem razredčiti (glejte navodila v poglavju 6.6).
Serum TTR reduction was maintained with continued dosing.
Zmanjšane ravni TTR v serumu so se ohranile z nadaljevanjem odmerjanja.
The most frequently occurring adverse reactions reported in Onpattro-treated patients were peripheral oedema (29.7%) and infusion-related reactions (18.9%).
Najpogostejši neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z zdravilom Onpattro, so bili periferni edem (29,7 %) in reakcije, povezane z infuzijo (18,9 %).
The MAH shall ensure that in each MS where Onpattro is marketed, all health care professionals (HCPs) and patients are provided with educational materials in order to ensure the safe and sustainable administration of the product in the home setting, aiming at preventing and/or minimising the important identified risk of Infusion Related Reactions (IRRs).
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, kjer je zdravilo Onpattro na trgu, vsi zdravstveni delavci in bolniki prejeli izobraževalna gradiva za zagotovitev varne in trajnostne uporabe zdravila v domačem okolju, s ciljem preprečiti in/ali zmanjšati pomembno ugotovljeno tveganje reakcij, povezanih z infuzijo.
Patients treated with Onpattro experienced statistically significant benefits in all secondary endpoints compared to patients who received placebo (all p <0.001) (Table 2).
Pri bolnikih, zdravljenih z zdravilom Onpattro, so se pokazale statistično značilne koristi v vseh sekundarnih opazovanih dogodkih v primerjavi z bolniki, ki so prejemali placebo (vsi p < 0,001) (preglednica 2).
• Reddening of the face or body (flushing), warm skin, or rash
• rdečina obraza ali telesa (zardevanje), topla koža ali izpuščaj
Do not stop treatment with Onpattro unless your doctor tells you to.
Ne prenehajte se zdraviti z zdravilom Onpattro, če vam tega ne naroči zdravnik.
Approximately 5.5% of DLin-MC3-DMA was recovered after 96 hours as its metabolite (DMBA) in urine.
Približno 5,5 % lipidne komponente DLin-MC3-DMA je bilo v obliki njenega presnovka (DMBA) po 96 urah izolirane v urinu.
The decision for a patient to receive home infusions should be made after evaluation and recommendation by the treating physician.
Odločitev o prehodu na infuzije doma mora temeljiti na presoji in priporočilu zdravnika, ki vodi zdravljenje.
Onpattro contains patisiran, a double-stranded small interfering ribonucleic acid (siRNA) that specifically targets a genetically conserved sequence in the 3' untranslated region of all mutant and wild-type TTR mRNA.
Zdravilo Onpattro vsebuje patisiran, ki je dvoverižna majhna interferenčna ribonukleinska kislina (siRNK - small interfering RNA), ki specifično cilja gensko ohranjeno zaporedje v 3' nekodirajoči regiji vseh mutiranih in nemutiranih mRNK TTR.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 10 mg/5 mL
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 10 mg/5 ml
• Onpattro does not contain preservatives.
• Zdravilo Onpattro ne vsebuje konzervansov.
If you have problems with your vision or any other eye problems whilst using Onpattro, you should talk to your doctor.
Če imate v času uporabe zdravila Onpattro težave z vidom ali kakršne koli druge težave z očmi, se posvetujte z zdravnikom.
Talk to your doctor about stopping breast-feeding or treatment with Onpattro.
Z zdravnikom se posvetujte o prenehanju dojenja ali zdravljenja z zdravilom Onpattro.
If a dose is missed, Onpattro should be administered as soon as possible.
Po izpuščenem odmerku je treba zdravilo Onpattro dati čim prej.
• In people with this illness, abnormally shaped TTR proteins clump together to make deposits called ‘amyloid'.
• Pri ljudeh s to boleznijo se nenavadno oblikovane beljakovine TTR združujejo v skupke, ki se imenujejo »amiloid«.
Infusion-related reaction
Reakcije, povezane z infuzijo
• Reasons triggering HCPs to consider whether the patient should stop home infusions and return to the clinic to receive the infusions.
• razlogih, zaradi katerih morajo zdravstveni delavci razmisliti o tem, ali naj bolnik preneha prejemati infuzije doma in jih ponovno prične prejemati v zdravstveni ustanovi.
Tell your doctor if you have an unplanned pregnancy.
Obvestite zdravnika, če ste nenačrtovano zanosili.
Table 1: Adverse reactions reported for Onpattro 300 micrograms per kg System Organ Class
Preglednica 1: Neželeni učinki, o katerih so poročali pri zdravilu Onpattro 300 mikrogramov na kg Organski sistem
4.7 Effects on ability to drive and use machines On the basis of the pharmacodynamic and pharmacokinetic profiles, Onpattro is considered to have no or negligible influence on the ability to drive or use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Na podlagi farmakodinamičnih in farmakokinetičnih profilov velja, da zdravilo Onpattro nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
If you have an infusion-related reaction, your doctor or nurse may slow down or stop your infusion, and you may need to take other medicines to control the symptoms.
Če imate reakcijo, povezano z infuzijo, lahko zdravnik ali medicinska sestra upočasnita ali ustavita infundiranje in morda boste morali vzeti druga zdravila za obvladovanje simptomov.
• The patient should be observed during the infusion and, if clinically indicated, following the infusion.
• Bolnika je treba med infundiranjem opazovati, in, če je to klinično indicirano, tudi po infundiranju.
• Cough, feeling short of breath, or other breathing problems
• kašelj, zasoplost ali druge težave z dihanjem
The components of Onpattro are not inhibitors or inducers of cytochrome P450 enzymes or transporters, except for CYP2B6 (see Section 4.5).
Sestavine zdravila Onpattro niso zaviralci ali induktorji encimov ali prenašalcev citokroma P450, razen CYP2B6 (glejte poglavje 4.5).
• If Onpattro is administered within 3 days of the missed dose, dosing should be continued according to the patient's original schedule.
• Če bolnik zdravilo Onpattro prejme v 3 dneh po izpuščenem odmerku, naj se zdravljenje nadaljuje po prvotnem načrtu za bolnika.
Your doctor will ensure that your vitamin A levels have returned to normal before you try to become pregnant.
Zdravnik bo zagotovil, da so se vam ravni vitamina A vrnile na normalne vrednosti, preden lahko poskušate zanositi.
• Calculate the required volume of Onpattro based on the recommended weight-based dosage (see section 4.2).
• Izračunajte potreben volumen zdravila Onpattro na podlagi priporočenega odmerka na osnovi telesne mase (glejte poglavje 4.2).
This medicinal product is for single-use only.
To zdravilo je samo za enkratno uporabo.
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).
Po potrebi se lahko daje dodatne ali večje odmerke enega ali več zdravil za premedikacijo, da se zmanjša tveganje reakcij, povezanih z infuzijo (glejte poglavji 4.4 in 4.8).
If a woman intends to become pregnant, Onpattro and vitamin A supplementation should be discontinued and serum vitamin A levels should be monitored and have returned to normal before conception is attempted.
Če ženska namerava zanositi, je treba dajanje zdravila Onpattro in nadomestka vitamina A prekiniti in spremljati ravni vitamina A v serumu, ki se morajo vrniti na normalno raven, preden poskusi zanositi.
PEG2000-C-DMG excretion in humans was not measured.
Izločanja PEG2000-C-DMG pri človeku niso izmerili.
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.
Povečanje odmerka patisirana je povzročilo večje zmanjšanje TTR, konstantna raven največjega zmanjšanja pri izpostavljenosti patisiranu pa je bila dosežena pri odmerjanju 300 mikrogramov na kg vsake 3 tedne.
• How the infusion is given;
• načinu dajanja infuzije;
Both too high and too low levels of vitamin A can harm the development of your unborn child.
Tako previsoke kot prenizke ravni vitamina A lahko škodujejo razvoju vašega nerojenega otroka.
To reduce the risk of IRRs, patients should receive premedications on the day of Onpattro infusion, at least 60 minutes prior to the start of infusion (see section 4.2).
Za zmanjšanje tveganja reakcij, povezanih z infuzijo, je treba bolnike na dan infundiranja zdravila Onpattro vsaj 60 minut pred začetkom infundiranja premedicirati (glejte poglavje 4.2).
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.
Učinkovitost zdravila Onpattro so proučevali v randomizirani, dvojno slepi, s placebom nadzorovani študiji z 225 bolniki z dedno transtiretinsko amiloidozo z mutacijo TTR in simptomatsko polinevropatijo.
As a precautionary measure, vitamin A and thyroid stimulating hormone (TSH) levels should be obtained early in pregnancy (see section 5.3).
Iz previdnostnih razlogov je treba izmeriti ravni vitamina A in tiroideo stimulirajočega hormona (TSH -Thyroid Stimulating Hormone) v zgodnji nosečnosti (glejte poglavje 5.3).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 16 hours at either 2°C to 8°C or room temperature (up to 30°C), including infusion time.
Če ga uporabnik ne uporabi takoj, je sam odgovoren za čas in pogoje shranjevanja pred uporabo, ki ne sme trajati več kot 16 ur pri temperaturi 2 °C - 8 °C ali pri sobni temperaturi (do 30 °C), vključno s časom infundiranja.
• Rapid heart rate
• hiter srčni utrip
It is unknown whether Onpattro is excreted in human milk.
Ni znano, ali se zdravilo Onpattro izloča v materino mleko.
• Discard vial if it has been frozen.
• Če je bila viala zamrznjena, jo zavrzite.
Through a natural process called RNA interference (RNAi), patisiran causes the catalytic degradation of TTR mRNA in the liver, resulting in a reduction of serum TTR protein.
V naravnem procesu, imenovanem interferenca RNK, patisiran povzroča katalitično razgradnjo mRNK TTR v jetrih, kar povzroči zmanjšanje ravni beljakovine TTR v serumu.
DLin-MC3-DMA is primarily metabolised to 4-dimethylaminobutyric acid (DMBA) by hydrolysis.
Lipidna komponenta DLin-MC3-DMA se primarno presnavlja v 4-dimetilaminomasleno kislino (DMBADimethylaminobutyric Acid) s hidrolizo.
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).
Približno polovica bolnikov (56 %) je ustrezala vnaprej določenemu merilu prizadetosti srca (opredeljeno kot debelina stene levega prekata ob izhodišču ≥ 13 mm brez hipertenzije ali bolezni aortne zaklopke v anamnezi).
In Onpattro-treated patients, the events decreased in frequency over time.
Pri bolnikih, zdravljenih z zdravilom Onpattro, se je pogostnost učinkov sčasoma zmanjšala.
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.
Bolniki, ki so prejemali zdravilo Onpattro, so imeli podobne koristi v primerjavi s placebom v rezultatih mNIS+7 in Norfolk QoL-DN v vseh podskupinah, vključno s starostjo, spolom, raso, regijo, rezultatom NIS, stanjem mutacije V30M, predhodno uporabo tafamidis meglumina ali diflunisala, stopnjo bolezni in bolniki z vnaprej določeno prizadetostjo srca.
Plasma protein binding of Onpattro is low, with ≤ 2.1% binding observed in vitro with human serum albumin and human α1-acid glycoprotein.
Vezava zdravila Onpattro na plazemske beljakovine je majhna, z ≤ 2,1 % vezave, opažene in vitro z albuminom iz človeškega seruma in človeškim α1-kislim glikoproteinom.
This endpoint is a composite measure of motor, sensory, and autonomic polyneuropathy including assessments of motor strength and reflexes, quantitative sensory testing, nerve conduction studies, and postural blood pressure, with the score ranging from 0 to 304 points, where an increasing score indicates worsening impairment.
Ta opazovani dogodek so sestavljale meritve motorične, senzorične in avtonomne polinevropatije, vključno z ocenami motorične zmogljivosti in refleksov, kvantitativno senzorično testiranje, študije prevajanja živcev in posturalni krvni tlak, pri čemer je bil razpon lestvice od 0 do 304 točk, višji rezultat pa pomeni slabšanje prizadetosti.
• The patient should be observed during the infusion and, if clinically indicated, following the infusion (see section 4.4).
• Bolnika je treba med infundiranjem opazovati, in, če je to klinično indicirano, tudi po infundiranju (glejte poglavje 4.4).
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).
Izpostavljenost patisiranu in lipidnim komponentam (DLin-MC3-DMA in PEG2000-C-DMG) se je večala sorazmerno z večanjem odmerka v razponu, ki so ga ocenili v kliničnih študijah (10 do 500 mikrogramov na kg).
• Withdraw the required volume of filtered Onpattro from the sterile container using a sterile syringe.
• Izvlecite potreben volumen filtriranega zdravila Onpattro iz sterilnega vsebnika s sterilno injekcijsko brizgo.
Patisiran is formulated as lipid nanoparticles to deliver the siRNA to hepatocytes, the primary source of TTR protein in the circulation.
Patisiran je formuliran v lipidne nanodelce za dostavo siRNK v hepatocite, ki so primarni vir beljakovine TTR v krvnem obtoku.
If not used immediately, store the diluted solution in the infusion bag at room temperature (up to 30°C) or at 2°C to 8°C for up to 16 hours (including infusion time).
Razredčeno raztopino, ki je ne uporabite takoj, shranjujte v infuzijski vreči pri sobni temperaturi (do 30 °C) ali pri temperaturi 2 °C - 8 °C do največ 16 ur (vključno s časom infundiranja).
Among Onpattro-treated patients who experienced an IRR, 78.6% experienced the first IRR within the first 2 infusions.
Med bolniki, ki so se zdravili z zdravilom Onpattro in so imeli reakcijo, povezano z infuzijo, jih je 78,6 % prvo reakcijo, povezano z infuzijo, doživelo med prvima 2 infuzijama.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 mg/5 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 10 mg/5 ml