FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not use Onpattro if you are pregnant, unless advised by your doctor.
Croatian: Nemojte uzimati Onpattro ako ste trudni, osim ako Vam je to savjetovao liječnik.
English: • Onpattro must be diluted prior to intravenous infusion (see instructions in section 6.6).
Croatian: • Onpattro se mora razrijediti prije intravenske infuzije (vidjeti upute u dijelu 6.6).
English: When these reactions stop, or get better, your doctor or nurse may decide to start the infusion again.
Croatian: Kad te reakcije prestanu ili se ublaže, Vaš liječnik ili medicinska sestra može odlučiti ponovno pokrenuti infuziju.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake ‚EXP'.
English: Women of childbearing potential
Croatian: Žene reproduktivnog potencijala
English: Onpattro has not been studied in patients with prior liver transplant; however, no dose adjustments are considered necessary.
Croatian: Onpattro nije ispitan u bolesnika s prethodno presađenom jetrom; međutim, ne smatra se potrebnim prilagođavati dozu.
English: Missed dose
Croatian: Propuštene doze
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Onpattro, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Onpattro uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Your doctor will tell you whether your condition allows you to drive vehicles and use machines safely.
Croatian: Vaš će Vam liječnik objasniti možete li sigurno upravljati vozilima i strojevima s obzirom na Vaše stanje.
English: This medicine contains 3.99 milligrams (mg) of sodium (main component of cooking/table salt) per millilitre (mL).
Croatian: Ovaj lijek sadrži 3,99 miligrama (mg) natrija (glavni sastojak kuhinjske/stolne soli) po mililitru (ml).
English: No data are available for patients weighing ≥ 110 kg.
Croatian: Težina Nema dostupnih podataka za bolesnike s tjelesnom težinom ≥ 110 kg.
English: The infusion site should be monitored for possible infiltration during administration.
Croatian: Mjesto infuzije treba nadzirati radi moguće infiltracije tijekom primjene.
English: Elderly patients No dose adjustment is required in patients ≥ 65 years of age (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika u dobi od ≥ 65 godina (vidjeti dio 5.2).
English: In the study, 148 patients received Onpattro and 77 patients received placebo.
Croatian: U ispitivanju, 148 bolesnika primalo je Onpattro, a 77 bolesnika primalo je placebo.
English: The infusion may need to be slowed down or stopped, and you may need to take other medicines to manage the reaction.
Croatian: Infuziju će možda trebati usporiti ili prekinuti i možda ćete morati uzimati druge lijekove radi liječenja reakcije.
English: Improvement was observed at 9 months, the first post-baseline assessment in the study.
Croatian: Poboljšanje je zabilježeno u 9. mjesecu, kod prve procjene nakon početne u ispitivanju.
English: The diluted solution should be administered immediately after preparation.
Croatian: Razrijeđenu otopinu potrebno je primijeniti odmah nakon pripreme.
English: The median patient age at baseline was 62 (range, 24 to 83) years and 74% of patients were male, 26% were female.
Croatian: Medijan dobi bolesnika na početnom pregledu bio je 62 (raspon od 24 do 83) godine, 74 % bolesnika bili su muškarci, a 26 % žene.
English: The only adverse reaction resulting in the discontinuation of Onpattro was an infusion-related reaction (0.7%).
Croatian: Jedina nuspojava koja je uzrokovala prekid primjene lijeka Onpattro bila je reakcija povezana s infuzijom (0,7 %).
English: Patients treated with Onpattro experienced statistically significant benefits in all secondary endpoints compared to patients who received placebo (all p <0.001) (Table 2).
Croatian: Bolesnici koji su primali Onpattro doživjeli su statistički značajne koristi u svim sekundarnim mjerama ishoda u usporedbi s bolesnicima koji su primali placebo (svi p < 0,001) (Tablica 2).
English: Less than 1% of patisiran in the administered dose was recovered intact in urine.
Croatian: Manje od 1 % patisirana iz primijenjene doze izlučeno je u urinu u nepromijenjenom obliku.
English: Antidrug antibody titres were low and transient with no evidence of an effect on clinical efficacy, the safety profile, or the pharmacokinetic or pharmacodynamic profiles of Onpattro.
Croatian: Titri protutijela na lijek bili su niski i prolazni, bez dokaza o utjecaju na kliničku djelotvornost, sigurnosni profil, ili na farmakokinetički ili farmakodinamički profil lijeka Onpattro.
English: DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine) Cholesterol
Croatian: DSPC (1,2-distearoil-sn-glicero-3-fosfokolin)
English: hATTR amyloidosis is caused by problems with a protein in the body called ‘transthyretin' (TTR).
Croatian: hATTR amiloidozu uzrokuju problemi s proteinom u tijelu koji se naziva ‚transtiretin' (TTR).
English: In general, all findings observed at the end of dosing in the rat and monkey toxicity studies had either a full recovery or were observed with reduced severity at the end of the 60-90 day recovery period, indicating at least partial reversibility.
Croatian: Općenito, svi nalazi opaženi na kraju doziranja u ispitivanjima toksičnosti na štakorima i majmunima pokazali su ili potpuni oporavak ili manju težinu na kraju razdoblja oporavka od 60-90 dana, što znači da su toksičnosti bile barem djelomično reverzibilne.
English: Pregnancy, breast-feeding and contraception
Croatian: Trudnoća, dojenje i kontracepcija
English: Tell your doctor if you are planning to become pregnant.
Croatian: Obratite se svojem liječniku ako planirate trudnoću.
English: The active substance in Onpattro is patisiran.
Croatian: Djelatna tvar u lijeku Onpattro je patisiran.
English: Vitamin A supplementation should be discontinued during the first trimester, unless the pregnant woman has clinical signs of vitamin A deficiency.
Croatian: A treba prekinuti tijekom prvog tromjesečja trudnoće, osim ako trudnica ima kliničke znakove nedostatka vitamina A.
English: • Onpattro will be given to you by a doctor or nurse.
Croatian: • Onpattro će Vam dati liječnik ili medicinska sestra.
English: Ninetythree percent (93%) of Onpattro-treated and 62% of placebo-treated patients completed 18 months of the assigned treatment.
Croatian: Devedeset i tri posto (93 %) bolesnika liječenih lijekom Onpattro i 62 % bolesnika koji su primali placebo završilo je 18 mjeseci dodijeljenog liječenja.
English: Peripheral oedema
Croatian: Periferni edem
English: Home infusions should be performed by a healthcare professional.
Croatian: Infuzije kod kuće treba davati zdravstveni radnik.
English: In Onpattro-treated patients, the events decreased in frequency over time.
Croatian: U bolesnika liječenih lijekom Onpattro, događaji su se s vremenom smanjili po učestalosti.
English: As patisiran is not pharmacologically active in rabbits, these effects are not due to reductions in TTR, thyroxine or vitamin A.
Croatian: Budući da patisiran nije farmakološki aktivan u kunića, ti učinci nisu posljedica smanjenja TTR-a, tiroksina ili vitamina A.
English: • Suitability of the patient for home infusion;
Croatian: • prikladnosti bolesnika za primjenu infuzije kod kuće
English: 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).
Croatian: Potrebno je pažljivo pratiti fetus u slučaju neplanirane trudnoće, osobito tijekom prvog tromjesečja (vidjeti dio 4.4).
English: INFORMATION IN BRAILLE Onpattro
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Onpattro
English: Table 1: Adverse reactions reported for Onpattro 300 micrograms per kg System Organ Class
Croatian: Tablica 1: Nuspojave prijavljene za Onpattro 300 mikrograma po kg Klasifikacija organskih sustava
English: If a dose is missed, Onpattro should be administered as soon as possible.
Croatian: U slučaju propuštene doze, Onpattro treba primijeniti što je prije moguće.
English: • Onpattro must be diluted prior to intravenous infusion.
Croatian: • Onpattro se mora razrijediti prije intravenske infuzije.
English: With repeat dosing every 3 weeks, mean reductions of serum TTR after 9 and 18 months of treatment were 83% and 84%, respectively.
Croatian: Uz ponovljeno doziranje svaka 3 tjedna, vrijednost proteina TTR u serumu nakon 9 i 18 mjeseci liječenja u prosjeku se smanjila za 83 % odnosno 84 %.
English: Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis.
Croatian: Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju amiloidoze.
English: 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).
Croatian: Nositelj odobrenja osigurat će da u svakoj državi članici u kojoj će lijek Onpattro biti stavljen u promet, svi zdravstveni radnici i bolesnici dobiju edukacijske materijale kako bi se zajamčila sigurna i održiva primjena lijeka kod kuće, čime se želi spriječiti i/ili minimizirati važan identificirani rizik od reakcija povezanih s infuzijom.
English: All events were mild or moderate in severity and did not lead to treatment discontinuation.
Croatian: Svi događaji bili su blage do umjerene težine i nisu zahtijevali prekid liječenja.
English: Approximately half (53%) of patients had prior treatment with tafamidis meglumine or diflunisal.
Croatian: Približno polovica (53 %) bolesnika prethodno je liječena tafamidismegluminom ili diflunisalom.
English: One additional patient had pre-existing anti-drug antibodies.
Croatian: Jedan je dodatni bolesnik prethodno imao protutijela na lijek.
English: • This protein is made mostly in the liver and carries vitamin A and other substances around the body.
Croatian: • Taj protein uglavnom nastaje u jetri te u tijelu prenosi vitamin A i druge tvari.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1320/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1320/001
English: Onpattro is given as a drip into a vein (called an ‘intravenous infusion').
Croatian: Onpattro se daje kapanjem u venu (što se naziva ‚intravenska infuzija').
English: The most frequently occurring adverse reactions reported in Onpattro-treated patients were peripheral oedema (29.7%) and infusion-related reactions (18.9%).
Croatian: Najčešće nuspojave prijavljene u bolesnika liječenih lijekom Onpattro bile su periferni edem (29,7 %) i reakcije povezane s infuzijom (18,9 %).
English: • Calculate the required volume of Onpattro based on the recommended weight-based dosage (see section 4.2).
Croatian: • Izračunajte potrebni volumen lijeka Onpattro na temelju preporučene doze temeljene na težini (vidjeti dio 4.2).
English: There are no data on the effects of Onpattro on human fertility.
Croatian: Nema podataka o utjecaju lijeka Onpattro na plodnost u ljudi.
English: 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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Onpattro u svim podskupinama pedijatrijske populacije s hATTR amiloidozom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Leakage of the drug into the surrounding tissue at the site of infusion, which may cause swelling or redness
Croatian: • curenje lijeka u okolno tkivo na mjestu primjene infuzije što može prouzročiti oticanje ili crvenilo
English: Approximately 10% of patients had the V30M mutation and early onset of symptoms (< 50 years of age).
Croatian: bolesnika imalo je mutaciju V30M i ranu pojavu simptoma (< 50 godina).
English: 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).
Croatian: Prije svake infuzije primit ćete lijekove koji pomažu smanjiti vjerojatnost reakcija povezanih s infuzijom (vidjeti „Lijekovi koji se daju tijekom liječenja lijekom Onpattro” u dijelu 3).
English: Suspected extravasation should be managed according to local standard practice for non-vesicants.
Croatian: U slučaju sumnje na ekstravazaciju, treba postupiti u skladu sa standardnom lokalnom praksom za lijekove koji nisu vezikanti.
English: Uncommon: may occur in up to 1 in 100 infusions
Croatian: Manje česte: mogu se javiti u manje od 1 na 100 infuzija
English: 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).
Croatian: Stoga žene reproduktivne dobi ne smiju biti trudne kada započinju liječenje lijekom Onpattro i moraju primjenjivati učinkovitu kontracepciju (pogledajte dio „Trudnoća, dojenje i kontracepcija“ u nastavku).
English: aAll endpoints analysed using the mixed-effect model repeated measures (MMRM) method.
Croatian: aSve mjere ishoda analizirane metodom miješanog modela s ponovljenim mjerenjima (engl. mixed-effect model repeated measures, MMRM).
English: Patisiran is not a substrate of cytochrome P450 enzymes.
Croatian: Patisiran nije supstrat enzima citokroma P450.
English: Placebo N=77
Croatian: Placebo N=77 Onpattro Placebo
English: Patients experienced benefit across all TTR mutations and the full range of disease severity studied.
Croatian: Kod bolesnika su opažene koristi u svim mutacijama proteina TTR i u cjelokupnom rasponu ispitanih stupnjeva težine bolesti.
English: • Calculate the required volume of Onpattro based on the recommended weight-based dosage.
Croatian: • Izračunajte potrebni volumen lijeka Onpattro na temelju preporučene doze temeljene na težini.
English: • Pain, redness, burning sensation, or swelling at or near the infusion site
Croatian: • bol, crvenilo, osjećaj žarenja ili oticanje na ili u blizini mjesta primjene infuzije
English: 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.
Croatian: U placebom kontroliranim i otvorenim kliničkim ispitivanjima, 7 od 194 (3,6 %) bolesnika s hATTR amiloidozom razvilo je protutijela na lijek tijekom liječenja lijekom Onpattro.
English: • Gently invert the bag to mix the solution.
Croatian: • Nježno preokrenite vrećicu da biste izmiješali otopinu.
English: 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.
Croatian: U slučaju predoziranja preporučuje se pratiti bolesnika za znakove ili simptome nuspojava i osigurati mu odgovarajuće simptomatsko liječenje.
English: Your doctor may tell you to stop taking Onpattro.
Croatian: Liječnik će Vam možda savjetovati da prestanete uzimati lijek Onpattro.
English: Tell your doctor if you have an unplanned pregnancy.
Croatian: Obratite se svojem liječniku ako ste neplanirano zatrudnjeli.
English: Intravenous administration of Onpattro had no effect on male reproductive assessments in sexually mature cynomolgus monkeys.
Croatian: Intravenska primjena lijeka Onpattro nije imala učinka na procjene reproduktivne sposobnosti mužjaka u spolno zrelih makaki majmuna.
English: Mean serum TTR was reduced by approximately 80% within 10 to 14 days after a single dose with 300 micrograms per kg Onpattro.
Croatian: Srednja vrijednost proteina TTR u serumu smanjena je za približno 80 % unutar 10 do 14 dana nakon jednokratne doze lijeka Onpattro od 300 mikrograma po kg.
English: These include anti-histamines, a corticosteroid (a medicine that suppresses inflammation), and a pain reliever.
Croatian: Ti lijekovi uključuju antihistaminike, kortikosteroid (lijek koji suzbija upalu) i lijek za ublažavanje boli.
English: IRRs resulted in permanent discontinuation of Onpattro in < 1% of patients in clinical studies.
Croatian: Reakcije povezane s infuzijom rezultirale su trajnim prekidom liječenja lijekom Onpattro kod < 1 % bolesnika u kliničkim ispitivanjima.
English: The educational material for HCPs should include information about:
Croatian: Edukacijski materijal za zdravstvene radnike treba uključivati informacije o:
English: 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.
Croatian: Ako imate reakciju povezanu s infuzijom, Vaš liječnik ili medicinska sestra možda će usporiti ili prekinuti Vašu infuziju, ili ćete možda morati uzeti druge lijekove radi kontrole simptoma.
English: • Reddening of the face or body (flushing), warm skin, or rash
Croatian: • crvenilo lica ili tijela (navale crvenila), topla koža ili osip
English: • Decrease in night vision, dry eyes, poor vision, hazy or cloudy vision
Croatian: • slabljenje noćnog vida, suhoću očiju, slab vid, nejasan ili zamagljen vid.
English: 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.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja pripremljenog lijeka prije primjene odgovornost su korisnika i ne bi trebali biti dulji od 16 sati na temperaturi od 2 °C do 8 °C ili na sobnoj temperaturi (do 30 °C), uključujući trajanje infuzije.
English: Talk to your doctor about stopping breast-feeding or treatment with Onpattro.
Croatian: Savjetujte se sa svojim liječnikom o prekidu dojenja ili liječenja lijekom Onpattro.
English: 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.
Croatian: Ta je mjera ishoda kompozitna mjera motoričke, senzorne i autonomne polineuropatije, koja uključuje procjene motoričke snage i refleksa, kvantitativnog senzornog testiranja, ispitivanja provodljivosti živaca i posturalnog krvnog tlaka, s rezultatom u rasponu od 0 do 304 boda, s time da rastući rezultat upućuje na pogoršavanje oštećenja.
English: Required premedication
Croatian: Potrebna premedikacija
English: • In people with this illness, abnormally shaped TTR proteins clump together to make deposits called ‘amyloid'.
Croatian: • U ljudi koji boluju od ove bolesti, pogrešno oblikovani proteini TTR spajaju se u nakupine i stvaraju naslage koje se nazivaju ‚amiloid'.
English: • The patient should be observed during the infusion and, if clinically indicated, following the infusion.
Croatian: • Bolesnika treba nadzirati tijekom i, ako je klinički indicirano, nakon infuzije.
English: There are no data on the use of Onpattro in pregnant women.
Croatian: Nema dostupnih podataka o primjeni lijeka Onpattro u trudnica.
English: 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.
Croatian: Ne očekuje se da će na Onpattro utjecati inhibitori ili induktori enzima citokroma P450 ili da će Onpattro uzrokovati interakcije s lijekovima, osim indukcije i o vremenu ovisne inhibicije CYP2B6 in vitro.
English: If the infusion is interrupted, resumption of the infusion at a slower infusion rate may be considered after symptoms have resolved.
Croatian: Ako se infuzija prekine, može se razmotriti mogućnost nastavka primjene infuzije manjom brzinom nakon zbrinjavanja simptoma.
English: During the first 3 months of your pregnancy, your doctor may tell you to stop your vitamin A supplement.
Croatian: Tijekom prva 3 mjeseca trudnoće liječnik će Vam možda reći da prestanete uzimati nadomjestak vitamina A.
English: All patients received premedication with a corticosteroid, paracetamol, and H1 and H2 blockers.
Croatian: Svi su bolesnici primili premedikaciju kortikosteroida, paracetamola, te H1 i H2 blokatora.
English: 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.
Croatian: Onpattro sadrži patisiran, dvolančanu malu interferirajuću ribonukleinsku kiselinu (engl. small interfering ribonucleic acid, siRNA) koja specifično cilja genetički očuvanu sekvencu u 3' netranslatiranoj regiji svih TTR mRNA s mutacijama i divljeg tipa.
English: 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.
Croatian: Putem prirodnog procesa koji se naziva RNA interferencija (RNAi) patisiran uzrokuje katalitičku razgradnju TTR mRNA u jetri, što dovodi do smanjenja proteina TTR u serumu.
English: Vitamin A testing
Croatian: Testiranje vitamina
English: Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Croatian: Onpattro je indiciran za liječenje nasljedne transtiretinske amiloidoze (hATTR amiloidoza) u odraslih bolesnika s 1. ili 2. stadijem polineuropatije.
English: In the event of an unplanned pregnancy, Onpattro should be discontinued (see section 4.6).
Croatian: U slučaju neplanirane trudnoće potrebno je prekinuti primjenu lijeka Onpattro (vidjeti dio 4.6).
English: Referral for ophthalmological assessment is recommended if patients develop ocular symptoms suggestive of vitamin A deficiency, including reduced night vision or night blindness, persistent dry eyes, eye inflammation, corneal inflammation or ulceration, corneal thickening or corneal perforation.
Croatian: Preporučuje se oftalmološki pregled ako se u bolesnika razviju očni simptomi koji upućuju na nedostatak vitamina A, uključujući smanjen noćni vid ili noćno sljepilo, perzistirajuću suhoću očiju, upalu očiju, upalu ili ulceraciju rožnice, zadebljanje rožnice ili perforaciju rožnice.
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.
Croatian: Bolesnici koji se liječe lijekom Onpattro moraju uzimati peroralni nadomjestak vitamina A u dozi od približno 2500 IU dnevno kako bi smanjili potencijalni rizik od očne toksičnosti zbog nedostatka vitamina A.
English: 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).
Croatian: Ako se ne primijeni odmah, otopinu razrijeđenu u vrećici za infuziju čuvajte na sobnoj temperaturi (do 30 °C) ili na temperaturi od 2 °C do 8 °C do 16 sati (uključujući trajanje infuzije).
English: • Onpattro is a white to off-white, opalescent, homogeneous concentrate for solution for infusion.
Croatian: • Onpattro je bijeli do bjelkasti, opalescentni, homogeni koncentrat za otopinu za infuziju.
English: 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).
Croatian: Da bi se smanjio rizik od reakcija povezanih s infuzijom, bolesnici trebaju primiti premedikacije na dan infuzije lijeka Onpattro, najmanje 60 minuta prije početka infuzije (vidjeti dio 4.2).