FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/L; one of these patients experienced a fatal intracranial haemorrhage.
Croatian: 9/l; jedan od tih bolesnika imao je intrakranijalno krvarenje sa smrtnim ishodom.
English: Hold the plunger fully down and wait for 5 seconds.
Croatian: Držite klip potpuno dolje i pričekajte 5 sekundi.
English: Before using your pre-filled syringe, your doctor should show you or your caregiver how to use it the right way.
Croatian: Prije korištenja napunjene štrcaljke, Vaš liječnik treba pokazati Vama ili Vašem skrbniku kako se ispravno koristi.
English: • To have a list of all other medicines they are using for any visit to a Health Care Professionals (HCP);
Croatian: • da nose popis svih drugih lijekova koje koriste prilikom svake posjete zdravstvenom radniku;
English: In addition to a prompt to include the contact details of the patient's physician and a call for reporting, the patient card should also:
Croatian: Nadalje, uz napomenu da se navedu podaci za kontakt liječnika bolesnika i poziv za prijavljivanje, kartica za bolesnika treba također:
English: Read the Instructions for Use before you start using your pre-filled syringe and each time you get a repeat prescription.
Croatian: Pročitajte upute za uporabu prije nego počnete koristiti napunjenu štrcaljku i svaki put kada primite ponovljen recept.
English: Weekly dosing should be continued.
Croatian: Treba nastaviti tjedno doziranje
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Croatian: Prvu injekciju koju primjenjuje bolesnik ili skrbnik treba obaviti pod vodstvom odgovarajuće kvalificiranog zdravstvenog radnika.
English: Elderly population No overall differences in pharmacokinetics were observed between other adult and elderly patients.
Croatian: Starije osobe Nisu uočene opće razlike u farmakokinetici između drugih odraslih i starijih bolesnika.
English: You will only be treated with Tegsedi if these are all at acceptable levels and your doctor will repeat these checks regularly during treatment.
Croatian: Liječit ćete se lijekom Tegsedi samo ako su sve ove vrijednosti na prihvatljivoj razini i Vaš liječnik će redovito ponavljati te pretrage tijekom liječenja.
English: If you or your caregiver have any questions, ask your doctor.
Croatian: Ako Vi ili Vaš skrbnik imate bilo kakvih pitanja, obratite se svom liječniku.
English: The safety and efficacy of inotersen in children and adolescents below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost inotersena u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: Lift here and pull to open
Croatian: Ovdje podignite i povucite za otvaranje
English: In addition, the corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Croatian: Nadalje, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećoj konvenciji: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
English: Call for immediate help if you have stiffness of the neck or an unusual and severe headache because these symptoms may be caused by bleeding in the brain.
Croatian: Odmah zatražite pomoć ako imate ukočen vrat ili neuobičajenu i jaku glavobolju jer je te simptome možda prouzročilo krvarenje u mozgu.
English: It should be removed from refrigerated storage at least 30 minutes before use.
Croatian: Potrebno ju je izvaditi iz hladnjaka najmanje 30 minuta prije primjene.
English: - An increase in the number of white blood cells called eosinophils in your blood
Croatian: - povećan broj bijelih krvnih stanica koje se nazivaju eozinofili u krvi
English: If the plunger does not rise up automatically when you release the pressure, it means the safety spring did not activate and you should push the plunger again but harder.
Croatian: Ako se klip ne podigne automatski kada opustite pritisak, znači da se sigurnosna opruga nije aktivirala i trebate gurnuti klip ponovno, ali jače.
English: Previous treatment with tafamidis or diflunisal
Croatian: Prethodno liječenje tafamidisom ili difluzinalom
English: For consistency of dosing, patients should be instructed to receive the injection on the same day every week.
Croatian: Radi konzistentnosti u doziranju, bolesnike treba upozoriti da trebaju primiti injekciju svaki tjedan na isti dan.
English: TTR is a carrier protein for retinol binding protein 4 (RBP4) which is the principal carrier of vitamin A (retinol).
Croatian: TTR je proteinski nosač retinol-vezujućeg proteina 4 (RBP4) koji je glavni nosač vitamina A (retinol).
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije kontuzija
English: In the event of an overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
Croatian: U slučaju predoziranja, potrebno je pružiti potpornu medicinsku skrb uključujući konzultacije sa zdravstvenim radnikom i pomno praćenje kliničkog stanja bolesnika.
English: When you do not have enough platelets, like in thrombocytopenia, your blood may not clot quickly enough to stop bleeding.
Croatian: Kada nemate dovoljan broj trombocita, kao u trombocitopeniji, Vaša krv se možda ne zgrušava dovoljnom brzinom da bi zaustavila krvarenje.
English: What you need to know before you use Tegsedi 3.
Croatian: Što morate znati prije nego počnete primjenjivati Tegsedi 3.
English: The most frequently observed adverse reactions during treatment with inotersen were events associated with injection site reactions (50.9%).
Croatian: Najčešće prijavljene nuspojave tijekom liječenja inotersenom bili su događaji vezani uz reakcije na mjestu injekcije (50,9%).
English: If not used, should be discarded.
Croatian: Ako se ne iskoristi, treba se baciti.
English: Consequently, only effects related to the chemistry of inotersen could be captured in these investigations.
Croatian: Posljedično, jedini učinci vezani uz kemiju inotersena mogu biti zabilježeni u tim istraživanjima.
English: * If the subsequent test confirms the initial test result, then monitoring frequency and dosing should be adjusted as recommended in the table.
Croatian: *Ako sljedeće pretrage potvrđuju rezultate početnih pretraga, tada je potrebno prilagoditi učestalost praćenja i doziranja onako kako je preporučeno u tablici.
English: After use, the safety spring is automatically activated and retracts the needle.
Croatian: Nakon uporabe se sigurnosna opruga automatski aktivira i povlači iglu unutra.
English: Patients were randomised 2:1 to receive either inotersen or placebo.
Croatian: Bolesnici su bili randomizirani 2:1 za primanje inotersena ili placeba.
English: Injection should be avoided at the waistline and other sites where pressure or rubbing from clothing may occur.
Croatian: Treba izbjegavati primjenu injekcije u području struka i druga mjesta gdje može doći do pritiska ili trljanja rublja.
English: Following subcutaneous administration, elimination half-life for inotersen is approximately 1 month.
Croatian: Nakon potkožne primjene, poluvijek eliminacije inotersena približno je 1 mjesec.
English: Doses should be administered once every week.
Croatian: Doze je potrebno primijeniti jedanput tjedno.
English: Children and adolescents Tegsedi should not be used in children and adolescents under 18 years old.
Croatian: Tegsedi se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: All subsequent doses should be injected once weekly on the same day each week.
Croatian: Sve sljedeće doze treba injicirati jedanput tjedno, svaki tjedan na isti dan.
English: If the solution is cloudy or contains visible particulate matter, the contents must not be injected.
Croatian: Ako je otopina zamućena ili sadrži vidljive čestice, sadržaj se ne smije injicirati.
English: Each pre-filled syringe contains one dose and is for one-time use only.
Croatian: Svaka napunjena štrcaljka sadrži jednu dozu i namijenjena je samo za jednokratnu uporabu.
English: • Alert HCPs that the patient is taking Tegsedi, its indication and the key safety concerns;
Croatian: • upozoriti zdravstvene radnike da bolesnik uzima Tegsedi, sadržavati njegove indikacije i ključne sigurnosne probleme;
English: If vitamin A supplementation is continued, the daily dose should not exceed 3000 IU per day, due to the lack of data supporting higher doses.
Croatian: Ako se nastavlja suplementacija vitaminom A, dnevna doza ne smije prekoračiti 3000 IU dnevno zbog nedostatka podataka u korist viših doza.
English: • Remove the plastic tray from the carton and check the expiry date.
Croatian: • Izvadite plastični podložak iz kutije i provjerite rok valjanosti.
English: Unchanged inotersen is the predominant circulating component.
Croatian: Neizmijenjen inotersen je glavna komponenta u cirkulaciji.
English: Slowly insert the needle into the chosen injection site at a 90° angle until it is fully inserted.
Croatian: Iglu polako ubodite u odabrano mjesto injiciranja pod kutom od 90°, sve dok nije potpuno uvedena.
English: Do not inject into tattoos, scars or damaged skin.
Croatian: Nemojte injicirati u tetovaže, ožiljke ili oštećenu kožu.
English: If not used within 6 weeks, it should be discarded.
Croatian: Ako se ne iskoristi u roku od 6 tjedana, treba se baciti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 July 2018
Croatian: Datum prvog odobrenja: 6. srpnja 2018.
English: What Tegsedi is and what it is used for 2.
Croatian: Što je Tegsedi i za što se koristi 2.
English: Yes No hATTR-CM2, n (%) hATTR-PN Disease Duration3 (months)
Croatian: Da Ne hATTR-CM2, n (%) hATTR-PN trajanje bolesti3 (mjeseci)
English: In the placebo group, mean serum TTR concentration decreased by 8.50% at Week 3 and then remained fairly constant throughout the treatment period.
Croatian: U skupini placeba, srednja vrijednost koncentracije TTR-a u serumu smanjila se za 8,50% u 3. tjednu i zatim je ostala prilično konstantna kroz cijelo razdoblje liječenja.
English: Statistical significance in favour of inotersen was demonstrated at all thresholds beyond a 0-point change.
Croatian: Statistička značajnost u korist inotersena bila je dokazana pri svim pragovima iza praga promjene od 0 bodova.
English: Genotoxicity/ carcinogenicity
Croatian: Genotoksičnost/kancerogenost
English: The pre-filled syringe should be allowed to reach room temperature prior to injection.
Croatian: Napunjena štrcaljka treba dostići sobnu temperaturu prije injekcije.
English: In the pivotal Phase 2/3 study, 30.4% of patients treated with inotersen tested positive for anti-drug antibodies following 15 months of treatment.
Croatian: U pivotalnom ispitivanju faze 2/3, 30,4% bolesnika liječenih inotersenom imali su pozitivne rezultate testova na protutijela na lijek nakon 15 mjeseci liječenja.
English: Due to the potential teratogenic risk arising from unbalanced vitamin A levels, inotersen should not be used during pregnancy, unless the clinical condition of the woman requires treatment with inotersen.
Croatian: Zbog mogućeg teratogenog rizika koji proizlazi iz neuravnoteženih razina vitamina A, inotersen se ne smije koristiti tijekom trudnoće, osim ako kliničko stanje žene zahtijeva liječenje inotersenom.
English: If unrefrigerated and not used within 6 weeks then this medicine should be discarded.
Croatian: Ako se ne čuva u hladnjaku i ne iskoristi u roku od 6 tjedana, lijek treba baciti.
English: If you develop glomerulonephritis, your doctor will treat you for this condition.
Croatian: Ako razvite glomerulonefritis, Vaš liječnik će Vas liječiti zbog te bolesti.
English: Precautions prior to initiation of inotersen
Croatian: Mjere opreza prije početka primjene inotersena
English: Some patients treated with inotersen have developed this condition.
Croatian: Određeni bolesnici liječeni inotersenom razvili su to stanje.
English: • dry eyes, poor vision, decrease in night vision, hazy or cloudy vision
Croatian: • suhe oči, slab vid, smanjen noćni vid, zamagljen ili nejasan vid
English: • To carry the card with them at all times during the treatment and up to 8 weeks following treatment discontinuation;
Croatian: • da imaju karticu uz sebe cijelo vrijeme dok traje liječenje i do 8 tjedana nakon prekida liječenja;
English: If you have problems with your sight or any other eye problems when you are using Tegsedi, you should speak to your doctor.
Croatian: Ako imate problema s vidom ili drugih problema s očima dok koristite Tegsedi, trebate razgovarati s liječnikom.
English: Urinary recovery of the parent medicinal product is limited to less than 1% within the 24 hours post dose.
Croatian: Izlučivanje nepromijenjenog lijeka u urinu ograničeno je na manje od 1% u roku od 24 sata nakon primjene doze.
English: Pharmacotherapeutic group: Other Nervous System Drugs, ATC code: N07XX15
Croatian: Farmakoterapijska skupina: Ostali lijekovi koji djeluju na živčani sustav, ATK oznaka: N07XX15
English: (eosinophilia) - Decreased appetite - Feeling faint or dizzy, especially on standing up (low blood pressure,
Croatian: (eozinofilija) - smanjen apetit - gubitak svijesti ili osjećaj omaglice, naročito pri ustajanju (niski krvni tlak,
English: Lift the whole pre-filled syringe straight up.
Croatian: Podignite cijelu napunjenu štrcaljku ravno prema gore.
English: Look in the inspection area to check that the solution is clear and colourless or pale yellow.
Croatian: Pogledajte područje za provjeru kako biste provjerili da je otopina bistra i bezbojna ili blijedožuta.
English: Inotersen did not exhibit genotoxic potential in in vitro and in vivo and was not carcinogenic in transgenic rasH2 mice.
Croatian: Inotersen nije pokazao genotoksični potencijal u in vitro i in vivo i nije bio kancerogen u transgeničnih rasH2 miševa.
English: Platelet count < 100 x 10
Croatian: Broj trombocita <100 x 10
English: No effect on the pharmacokinetic properties (Cmax, AUC or half-life) and efficacy of inotersen was observed in the presence of anti-drug antibodies, but patients with anti-drug antibodies had more reactions at the injection site.
Croatian: Nije opažen utjecaj na farmakokinetička svojstva (Cmax, AUC ili poluvijek) i djelotvornost inotersena u prisutnosti protutijela na lijek, ali bolesnici s protutijelima na lijek imali su više reakcija na mjestu injekcije.
English: You may need to press a little harder on the plunger to make sure you have pushed it as far as it will go.
Croatian: Tada morate malo jače pritisnuti na klip kako biste bili sigurni da je gurnut do kraja.
English: In the case of a decrease in eGFR >30%, in the absence of an alternative explanation, pausing of inotersen dosing should be considered pending further evaluation of the cause.
Croatian: U slučaju smanjenja eGFR-a >30%, ako ne postoji drukčije objašnjenje, potrebno je uzeti u obzir stanku u doziranju inotersena dok se dodatno ne procijeni uzrok.
English: Subjects with Stage 1 and Stage 2 hATTR-PN and an NIS ≥10 and ≤130 were recruited in the pivotal NEURO-TTR study.
Croatian: Ispitanici s 1. i 2. stadijem hATTR-PN i NIS ≥10 i ≤130 bili su uključeni u pivotalno ispitivanje NEURO-TTR.
English: Hold the skin around at the injection site as your healthcare provider has instructed you.
Croatian: Držite kožu na mjestu injiciranja, kako Vas je uputio zdravstveni radnik.
English: Consider more frequent monitoring if additional risk factors for bleeding are present.
Croatian: Uzeti u obzir češće praćenje ako su prisutni dodatni rizični čimbenici za krvarenje.
English: The disease hATTR-PN is classified into 3 stages such that i) Stage 1 patients do not require assistance with ambulation, ii) Stage 2 patients do require assistance with ambulation, and iii) Stage 3 patients are bound to wheelchair.
Croatian: Bolest hATTR-PN klasificirana je u 3 stadija kako slijedi: i) bolesnici u 1. stadiju ne zahtijevaju pomoć pri hodanju, ii) bolesnici u 2. stadiju zahtijevaju pomoć pri hodanju, a iii) bolesnici u 3. stadiju
English: Tegsedi is used when the disease is causing symptoms of polyneuropathy (nerve damage).
Croatian: Tegsedi se koristi kada bolest uzrokuje simptome polineuropatije (oštećenje živaca).
English: Consider corticosteroids if additional risk factors for bleeding are present.
Croatian: Uzeti u obzir primjenu kortikosteroida ako su prisutni dodatni rizični čimbenici za krvarenje.
English: Inotersen is a 2′-O-2-methoxyethyl (2′-MOE) phosphorothioate antisense oligonucleotide (ASO) inhibitor of human transthyretin (TTR) production.
Croatian: Inotersen je 2′-O-2-metoksietil (2′-MOE) fosforotioat antisens oligonukleotidni (ASO) inhibitor proizvodnje ljudskog transtiretina (TTR).
English: Tegsedi is for injection under the skin (subcutaneous use) only.
Croatian: Tegsedi je namijenjen samo za injiciranje pod kožu (supkutana primjena).
English: Talk to your doctor before using TEGSEDI if you have previously received a liver transplant.
Croatian: Razgovarajte sa svojim liječnikom prije uzimanja lijeka Tegsedi ako ste prethodno primili presadak jetre.
English: Based on the mechanism of action, inotersen is expected to reduce plasma vitamin A (retinol) below normal levels (see section 5.1).
Croatian: Na temelju mehanizma djelovanja, očekuje se da će inotersen smanjiti količinu vitamina A (retinola) u plazmi ispod normalnih razina (vidjeti dio 5.1).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Tegsedi therapy 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 Tegsedi uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: mean (SD) hATTR-CM Disease Duration
Croatian: srednja vrijednost (SD) hATTR-CM trajanje bolesti
English: - 1 Pre-filled syringe from the refrigerator - 1 Alcohol wipe (not supplied) - 1 Gauze pad or cotton ball (not supplied) - 1 Puncture-resistant (sharps) container (not supplied)
Croatian: - 1 napunjena štrcaljka iz hladnjaka - 1 alkoholna maramica (nije priložena u pakiranju) - 1 jastučić gaze ili pamučni tupfer (nije priloženo u pakiranju) - 1 spremnik za oštre predmete (nije priložen u pakiranju)
English: hypotension) - Bruising - Collection of blood within the tissues, that may look similar to severe bruising
Croatian: hipotenzija) - modrice - nakupljanje krvi u tkivima, koje može izgledati slično teškim modricama
English: You should not use Tegsedi if you are pregnant, unless explicitly advised by your doctor.
Croatian: Ne smijete primjenjivati Tegsedi ako ste trudni, osim ako Vam to izričito ne preporuči liječnik.
English: If injected in the upper arm, the injection should be administered by another person.
Croatian: Ako se injekcija primjenjuje u nadlakticu, treba je primijeniti druga osoba.
English: However, inotersen is not pharmacologically active in mice and rabbits.
Croatian: Međutim, inotersen nije farmakolokši aktivan u miševa i kunića.
English: Do not inject the medicine until you have gathered the supplies listed.
Croatian: Nemojte injicirati lijek dok niste pripremili navedeni materijal.
English: Hold the pre-filled syringe in 1 hand.
Croatian: Držite napunjenu štrcaljku jednom rukom.
English: The needle should now be retracted safely inside the pre-filled syringe, and the safety mechanism spring visible on the outside of the plunger.
Croatian: Igla treba sada biti sigurnosno uvučena u napunjenu štrcaljku, a opruga sigurnosnog mehanizma vidljiva s vanjske strane klipa.
English: Also contains: hydrochloric acid, sodium hydroxide, water for injections.
Croatian: Sadrži također: kloridnu kiselinu, natrijev hidroksid, vodu za injekcije.
English: INFORMATION IN BRAILLE Tegsedi
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Tegsedi
English: Still, no effect on embryo-foetal development was noted with a mouse-specific analogue of inotersen in mice, which was associated with ~60% inhibition (individual range up to 90% reduction) of TTR mRNA expression.
Croatian: No ipak, nije zabilježen učinak na embriofetalni razvoj s analogom inotersena specifičnim za miševe, koji je bio vezan uz inhibiciju od ~60% (pojedinci su varirali do smanjenja od 90%) ekspresije TTR mRNK.
English: Patients were stratified for stage of disease (Stage 1 versus Stage 2), TTR mutation (V30M versus non-V30M) and previous treatment with either tafamidis or diflunisal (yes versus no).
Croatian: Bolesnici su bili stratificirani prema stadiju bolesti (1. stadij naspram 2. stadija), mutaciji TTR-a (V30M naspram non-V30M) i prethodno liječenje tafamidisom ili diflunizalom (da naspram ne).
English: Results across multiple disease characteristics [TTR mutation (V30M, non-V30M)], disease stage (Stage 1, Stage 2), previous treatment with tafamidis or diflunisal (yes, no), presence of hATTR-CM (yes, no) at Week 66 showed statistically significant benefit in all subgroups based on mNIS+7 composite score and all but one of these subgroups (CM-Echo Set; p=0.067) based on Norfolk QoL-DN total score (Table 5).
Croatian: Rezultati svih višestrukih obilježja bolesti [TTR mutacija (V30M, non-V30M)], stadij bolesti (1. stadij, 2. stadij), prethodna liječenja tafamidisom ili diflunizalom (da, ne), prisutnost hATTR-CM (da, ne) u 66. tjednu pokazali su statistički značajne koristi u svim podskupinama na temelju kompozitnog rezultata prema mNIS+7 i sve osim jedne od ovih podskupina (CM-Echo Set; p=0,067) na temelju ukupnog rezultata prema Norfolk QoL-DN (Tablica 5).
English: Milk transfer of inotersen was low in mice.
Croatian: Prelazak inotersena u mlijeko bio je nizak u miševa.
English: Platelet counts returned to normal when treatment was stopped but dropped to even lower levels when inotersen aministration was resumed.
Croatian: Broj trombocita vratio se u normalu kada je liječenje prekinuto, ali je pao na još niže razine kada je inotersen ponovno primijenjen.
English: Other most commonly reported adverse reactions with inotersen were nausea (31.3%), anaemia (27.7%), headache (23.2%), pyrexia (19.6%), peripheral oedema (18.8%), chills (17.9%), vomiting (15.2%), thrombocytopenia (13.4%) and platelet count decreased (10.7%).
Croatian: Druge najčešće prijavljivane nuspojave s inotersenom bile su mučnina (31,3%), anemija (27,7%), glavobolja (23,2%), pireksija (19,6%), periferni edem (18,8%), zimica (17,9%), povraćanje (15,2%), trombocitopenija (13,4%) i smanjen broj trombocita (10,7%).
English: Inotersen is highly bound to human plasma protein (> 94%) and the fraction bound is independent of drug concentration.
Croatian: Inotersen se veže u visokom postotku za proteine ljudske plazme (>94%) i vezana frakcija je neovisna o koncentraciji lijeka.
English: Do not remove needle cap until you have reached Step 6 of these instructions and are ready to inject Tegsedi;
Croatian: Nemojte uklanjati kapicu igle dok niste dosegli korak br. 6 ovih uputa i dok niste spremni za injiciranje lijeka Tegsedi;
English: Development of anti-drug antibodies to inotersen was characterised by late onset (median onset > 200 days) and low titer (median peak titer of 284 in the pivotal study).
Croatian: Razvoj protutijela na lijek u slučaju inotersena bio je karakteriziran kasnom pojavom (medijan pojave >200 dana) i niskim titrom (medijan najvišeg titra od 284 u pivotalnom ispitivanju).