FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use the pre-filled syringe if the needle appears damaged.
Croatian: Nemojte koristiti napunjenu štrcaljku ako igla izgleda oštećena.
English: Urine tests
Croatian: Pretrage urina
English: Do not freeze the Waylivra pre-filled syringe.
Croatian: Nemojte zamrzavati Waylivra napunjenu štrcaljku.
English: Clean your chosen injection site with an alcohol pad (Figure G).
Croatian: Očistite odabrano mjesto injekcije jastučićem namočenim alkoholom (slika G).
English: The active substance is volanesorsen.
Croatian: Djelatna tvar je volanesorsen.
English: Very common (N, %)
Croatian: Vrlo često (N, %)
English: Do not use this medicine if the solution is cloudy or contains particles; it should be clear and colourless to slightly yellow.
Croatian: Nemojte upotrebljavati ovaj lijek ako je otopina zamućena ili sadrži vidljive čestice; mora biti bistra i bezbojna do blijedo žuta.
English: It is unknown whether triglyceride lowering by volanesorsen and the potentially ensuing decrease in inflammation leads to normalisation of CYP enzyme expression.
Croatian: Ne zna se da li sniženje triglicerida od strane volanesorsena te potencijalno smanjenje upale vodi ka normalizaciji ekspresije CYP enzima.
English: No evidence of altered safety profile or clinical response was associated with presence of anti-drug antibodies.
Croatian: Nema dokaza izmijenjenog sigurnosnog profila ili kliničkog odgovora povezanog s prisutnošću protutijela na lijek.
English: Compliance with diet and alcohol restriction was reinforced through periodic counselling sessions during the study.
Croatian: Pridržavanje dijete i ograničenje unosa alkohola bilo je ojačano kroz periodička savjetovanja bolesnika tijekom ispitivanja.
English: Following subcutaneous injection, peak plasma concentrations of volanesorsen are typically reached in 2 to 4 hours.
Croatian: Nakon supkutane injekcije, vršne plazmatske koncentracije volanesorsena obično se dosežu u 2 do 4
English: Do not take out of the packaging or remove the needle cap until you are ready to inject.
Croatian: Nemojte vaditi iz pakiranja ili skidati kapicu za iglu sve dok niste spremni za injiciranje.
English: Based on the population pharmacokinetic analysis, age, body weight, sex, or race has no clinically relevant effect on volanesorsen exposure.
Croatian: Na temelju farmakokinetičke populacijske analize, dob, tjelesna težina, spol ili rasa nemaju klinički značajnog utjecaja na izloženost volanesorsenu.
English: Patients were prohibited from receiving plasma apheresis within 4 weeks prior to screening or during the study; 11% of patients had previously received gene therapy for lipoprotein lipase deficiency (i.e., alipogene tiparvovec), on average 8 years prior to starting this study.
Croatian: Bolesnicima je bilo zabranjeno primati plazmaferezu unutar 4 tjedna prije probira ili tijekom ispitivanja; 11% bolesnika prethodno je primalo gensku terapiju za nedostatak lipoprotein lipaze (tj. alipogen tiparvovek), u prosjeku 8 godina prije početka ovog ispitivanja.
English: There is no clinical experience with overdose of this medicinal product.
Croatian: Nema kliničkog iskustva s predoziranjem ovim lijekom.
English: FCS is a genetic disease which gives rise to abnormally high levels of fats called triglycerides in the blood.
Croatian: FCS je genetska bolest koja uzrokuje abnormalno visoke razine masnoća u krvi zvanih trigliceridi.
English: LS Mean Percent Change (95% CI)
Croatian: LS srednja vrijednost postotka promjene (95% CI)
English: Some accumulation in AUC and Cmax was observed for the 50 to 100 mg dose.
Croatian: Uočena je određena akumulacija u AUC i Cmax za dozu od 50 do 100 mg.
English: Avoid injecting at the waistline where your clothing may rub or press the injection area.
Croatian: Izbjegavajte injiciranje u području struka gdje bi Vaša odjeća mogla trljati ili pritiskati područje davanja injekcije.
English: Waylivra is not likely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će Waylivra utjecati na vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: When you first receive Waylivra the pre-filled syringes should be stored in their packaging in the refrigerator (2 °C-8 °C).
Croatian: Kada prvi put dobijete pakiranje lijeka Waylivra, napunjenu štrcaljku u njenom pakiranju treba staviti i čuvati u hladnjaku (2 °C-8 °C ).
English: Symptoms of overdose are expected to be limited to constitutional symptoms and injection site reactions.
Croatian: Očekuje se da će simptomi predoziranja biti ograničeni na opće simptome i reakcije na mjestu injekcije.
English: It is preferable to avoid the use of Waylivra during pregnancy.
Croatian: Preporučuje se izbjegavati uporabu lijeka Waylivra tijekom trudnoće.
English: Following 3 months, dose frequency should be reduced to 285 mg every 2 weeks.
Croatian: Nakon 3 mjeseca, učestalost doziranja treba smanjiti na 285 mg svaka 2 tjedna.
English: In the case of overdose, patients should be carefully observed and supportive care administered, as appropriate.
Croatian: U slučaju predoziranja, bolesnike treba pomno nadzirati te primijeniti potpornu skrb prema potrebi.
English: Alternate the injection area for each injection.
Croatian: Mijenjajte mjesta davanja injekcije za svaku injekciju.
English: o Relevant information on thrombocytopaenia and severe bleeding o Details of the population at higher risk for thrombocytopaenia and bleeding (e.g. those with weight less than 70 kg), and patients for which Waylivra is contraindicated (i.e. patients with chronic or unexplained thrombocytopaenia)
Croatian: o Relevantne informacije o trombocitopeniji i teškom krvarenju o Pojedinosti o populaciji pod povišenim rizikom od tromboctipenije i krvarenja (tj. onima koji teže manje od 70 kg) te bolesnicima za koje je Waylivra kontraindicirana (tj. bolesnicima s kroničnom ili nerazjašnjenom trombocitopenijom)
English: Throw away the needle cap after injecting.
Croatian: Bacite kapicu za iglu nakon injiciranja.
English: Injection site reactions did not occur with all injections and resulted in discontinuation for 1 patient in the APPROACH study.
Croatian: Reakcije na mjestu injekcije nisu se javile kod svake primjene injekcije te su rezultirale prekidom sudjelovanja jednog bolesnika u ispitivanju APPROACH.
English: No clinical drug interaction studies have been conducted.
Croatian: Nisu provedena ispitivanja kliničkih interakcija lijeka.
English: Waylivra contains the active substance volanesorsen, which helps to treat a condition called familial chylomicronemia syndrome (FCS).
Croatian: Waylivra sadrži djelatnu tvar volanesorsen koja pomaže u liječenju stanja zvanog sindrom obiteljske hilomikronemije (FCS).
English: Monitoring for hepatotoxicity through serum liver enzymes and bilirubin should be assessed on a quarterly basis.
Croatian: Potrebno je praćenje hepatotoksičnosti kroz serumske jetrene enzime i bilirubin na kvartalnoj bazi.
English: Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with FCS.
Croatian: Liječenje treba započeti i nadzirati liječnik iskusan u liječenju bolesnika s FCS-om.
English: The decrease in platelet counts was not acute and decreased to below 50,000 cells/μl.
Croatian: Pad broja trombocita nije bio akutan te se smanjio na ispod 50 000 stanica/μl.
English: Before starting this medicine, you should be on a diet designed to help lower triglyceride levels in your blood.
Croatian: Prije primjene ovog lijeka morate biti na dijeti koja je osmišljena za snižavanje razine triglicerida u Vašoj krvi.
English: If the syringe was in the refrigerator, allow the prefilled syringe to reach room temperature by removing it from the refrigerator at least 30 minutes before the injection.
Croatian: Ako je štrcaljka bila u hladnjaku, pustite da napunjena štrcaljka dosegne sobnu temperaturu vadeći je iz hladnjaka barem 30 minuta prije davanja injekcije.
English: LS Mean Absolute Change (95% CI) mg/dL or mmol/L
Croatian: LS srednja vrijednost apsolutne promjene (95% CI) mg/dl ili mmol/l
English: Careful monitoring for thrombocytopenia is important during treatment with this medicinal product in patients with FCS (see section 4.2).
Croatian: Pažljivo praćenje trombocitopenije važno je tijekom liječenja ovim lijekom u bolesnika s FSC (vidjeti dio 4.2).
English: There were no significant differences in treatment effect across the stratification factors of presence or absence of concurrent omega-3 fatty acids or fibrates.
Croatian: Nije bilo značajnih razlika u učinku liječenja gledano prema faktorima stratifikacije koji su bili: prisutnosti ili odsutnosti istodobne primjene omega-3 masnih kiselina ili fibrata.
English: Clear, colourless to slightly yellow solution with a pH of approximately 8 and osmolarity of 363-485 mOsm/kg.
Croatian: Bistra, bezbojna do žućkasta otopina s pH približno 8 i osmolalnošću od 363 do 485 mOsm/kg.
English: Inject the liquid by holding the syringe with your thumb on the plunger, and slowly push the plunger down as far as it will go, until the syringe is completely empty (Figure K and L).
Croatian: Injicirajte tekućinu tako što ćete držeći palac na klipu štrcaljke lagano pogurati klip prema dolje koliko je moguće, sve dok štrcaljka ne bude potpuno prazna (slike K i L).
English: Mean age was 46 years (range 20-75 years; 5 patients ≥65 years old); 45% were men; 80% were White, 17% were Asian, and 3% were of other races.
Croatian: Prosječna dob je bila 46 godina (raspon od 20 do 75 godina; 5 bolesnika ≥ 65 godina); 45% bolesnika bili su muškarci; 80% bili su bijelci, 17% azijskog podrijetla, a 3% pripadali su ostalim rasama.
English: Single- and multiple-dose pharmacokinetics of volanesorsen in healthy volunteers and patients with hypertriglyceridemia have shown that the Cmax of volanesorsen is dose-proportional over a dose range of 100 to 400 mg and the AUC is slightly more than dose-proportional over the same dose range.
Croatian: Farmakokinetika pojedinačnih i višestrukih doza volanesorsena u zdravih dobrovoljaca i bolesnika s hipertrigliceridemijom pokazala je da je Cmax volanesorsena proporcionalan dozi za raspone doza od 100 do 400 mg, a AUC je blago viši od proporcionalnog dozi u istom rasponu doziranja.
English: It is important to tell your doctor if you are already being treated with any of the following: - Medicines to prevent blood clots, e.g., acetylsalicylic acid, dipyridamol or warfarin.
Croatian: Važno je da obavijestite svog liječnika ako ste već liječeni bilo čime od sljedećeg: - Lijekovima za sprječavanje krvnih ugrušaka, npr. acetilsalicilatnom kiselinom, dipiridamolom ili varfarinom.
English: Your doctor will do a blood test before you start using this medicine to check the number of platelets, and then at regular intervals once you have started using Waylivra to check on platelet levels.
Croatian: Vaš liječnik će provesti krvne pretrage prije nego počnete uzimati ovaj lijek kako biste provjerili broj trombocita i potom će ih redovito provoditi nakon što počnete uzimati Waylivru kako biste provjerili razine trombocita.
English: Volanesorsen was rapidly and widely distributed to tissues following subcutaneous or intravenous administration in all species evaluated.
Croatian: Volanesorsen se brzo i široko distribuirao u tkiva nakon supkutane ili intravenske primjene u svim ispitivanim vrstama.
English: The other ingredients are water for injections, sodium hydroxide and hydrochloric acid (to adjust acidity level, see section 2 under ‘Sodium').
Croatian: Ostali sastojci su voda za injekcije, natrijev hidroksid i kloridna kiselina (za prilagodbu razine kiselosti) (vidjeti dio 2 pod „Natrij“).
English: If the platelet count is below 140 x 109/L another measurement should be taken approximately a week later to reassess.
Croatian: Ako je broj trombocita ispod 140 x109/l, potrebno je obaviti drugo mjerenje približno tjedan dana kasnije kako bi se provela ponovna procjena.
English: Immediately after the injection, dispose of the used syringe as instructed by your healthcare professional, usually into a sharps disposal container (Figure N) by following these steps.
Croatian: Odmah nakon davanja injekcije, bacite iskorištenu štrcaljku suklado uputama Vašeg liječnika, obično u spremnik za oštre predmete (slika N), pridržavajući se ovih koraka.
English: Platelet counts recovered after cessation of treatment, but decreased again below 50,000 cells/μl after treatment was resumed in some monkeys.
Croatian: Razine trombocita oporavile su se nakon završetka primjene, ali opet su pale ispod 50 000 stanica/μl nakon nastavka liječenja u nekih majmuna.
English: The objective of the programme is to provide information on the risks of thrombocytopaenia and bleeding; advise on platelet monitoring and provide details about the dose frequency adjustment algorithm.
Croatian: Cilj programa je pružiti informacije o rizicima trombocitopenije i krvarenja; savjetovati o praćenju trombocita te pružiti pojedinosti o algoritmu prilagodbe učestalosti doziranja.
English: If formation of anti-drug antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Croatian: Ako se sumnja na stvaranje protutijela na lijek s klinički značajnim učinkom, obratite se nositelju odobrenja za stavljanje lijeka u promet kako biste raspravili mogućnost pretraga na protutijela.
English: If the solution is cloudy or contains visible particulate matter, the contents must not be injected and the medicinal product should be returned to the pharmacy.
Croatian: Ako je otopina zamućena ili sadrži vidljive čestice, sadržaj se ne smije injicirati i lijek se mora vratiti u ljekarnu.
English: If it is not used within 6 weeks after first removing from the refrigerator, the medicine should be discarded.
Croatian: Ako se ne upotrijebi unutar 6 tjedana nakon prvog vađenja iz hladnjaka, lijek treba baciti.
English: If any of the above apply to you, or you are not sure, talk to your doctor, nurse or pharmacist before using Waylivra.
Croatian: Ako se išta od prethodno navedenog odnosi na Vas ili ako niste sigurni, razgovarajte sa svojim liječnikom, medicinskom sestrom ili ljekarnikom prije uporabe Waylivre.
English: Volanesorsen has no or negligible influence on the ability to drive and use machines.
Croatian: Volanesorsen ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
Croatian: • Edukacijski materijal za liječnika treba sadržavati: o Sažetak opisa svojstava lijeka o Vodič za zdravstvene radnike
English: Common (N, %)
Croatian: Često (N, %)
English: Injecting the solution with the air bubble is harmless.
Croatian: Injiciranje otopine sa zračnim mjehurićem nije štetno.
English: In the case of a positive assessment, a broader assessment of renal function, including serum creatinine and a 24-hour collection to quantify the proteinuria and assess creatinine clearance, should be performed.
Croatian: U slučaju pozitivnog rezultata, potrebno je provesti širu procjenu bubrežne funkcije, uključujući serumski kreatinin i 24-satno prikupljanje urina kako bi se kvantitativno procijenila proteinurija te klirens kreatinina.
English: Do not use this medicine after the expiry date which is stated on the carton and syringe label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici štrcaljke iza oznake „EXP”.
English: Injection with cold liquid may cause injection site reactions such as pain, redness, or swelling.
Croatian: Injekcija koja sadrži hladnu tekućinu može uzrokovati reakcije na mjestu injekcije poput boli, crvenila ili oticanja.
English: Monitoring for evidence of nephrotoxicity by routine urine dipstick is recommended on a quarterly basis.
Croatian: Praćenje dokaza na nefrotoksičnost rutinskim testiranjem urina test trakicom preporučeno je na kvartalnoj bazi.
English: - A low number of platelets, a type of cell in your blood that clump together to help it clot (thrombocytopenia); your doctor will do a blood test before you start using this medicine to check the number of platelets in your blood.
Croatian: - Vrlo nizak broj trombocita, vrste stanica u Vašoj krvi koje stvaraju nakupine kako bi se Vaša krv zgrušala (trombocitopenija); Vaš liječnik će provesti krvne pretrage prije početka primjene ovog lijeka kako bi provjerio broj trombocita u Vašoj krvi.
English: What you need to know before you use Waylivra 3.
Croatian: Što morate znati prije nego počnete primjenjivati Waylivru
English: All patients enrolled either had participated in the APPROACH Study, in the CS16 Study, or were new FCS patients and had completed qualification assessments prior to receiving volanesorsen 285 mg once per week or a reduced frequency for safety or tolerability reasons determined in their index study.
Croatian: Svi uključeni bolesnici ili su sudjelovali u ispitivanju APPROACH, u ispitivanju CS16 ili su bili novi bolesnici s FSC-om te su dovršili kvalifikacijske procjene prije početka primanja 285 mg volanesorsena jednom na tjedan ili manjom učestalosti iz razloga sigurnosti ili podnošljivosti određenih u njihovom indeksirajućem ispitivanju.
English: Your doctor may do a urine and/or blood test every 3 months to check for signs of damage to your kidneys.
Croatian: Vaš liječnik može provesti pretrage urina i/ili krvi svaka 3 mjeseca kako bi provjerio ima li znakova oštećenja vaših bubrega.
English: Injection should be avoided at the waistline and other sites where pressure or rubbing may occur from clothing.
Croatian: Potrebno je izbjegavati davanje injekcije u struk i druga mjesta gdje bi moglo doći do pritiska ili trljanja od odjeće.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of very low amounts of volanesorsen in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazali su da se vrlo niska količina volanesorsena izlučuje u majčino mlijeko (vidjeti dio 5.3).
English: If the expiry date on the syringe label has passed during the 6 week period at room temperature, the syringe should not be used and should be discarded.
Croatian: Ako je datum isteka roka valjanosti na naljepnici štrcaljke istekao tijekom 6-tjednog razdoblja čuvanja na sobnoj temperaturi, štrcaljka se ne smije upotrijebiti i treba je baciti.
English: Steady-state was reached approximately 3 months after starting volanesorsen.
Croatian: Stanje dinamičke ravnoteže postiže se približno 3 mjeseca nakon početka terapije volanesorsenom.
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 si daje bolesnik sam ili mu je daje njegovatelj potrebno je izvesti pod vodstvom odgovarajuće kvalificiranog zdravstvenog radnika.
English: However, treatment should be discontinued in patients with a reduction in serum triglycerides <25% or who fail to achieve serum triglycerides below 22.6 mmol/L after 3 months on volanesorsen 285 mg weekly.
Croatian: Međutim, liječenje treba prekinuti u bolesnika sa smanjenjem serumskih triglicerida < 25 % ili koji ne uspiju postići razinu serumskih triglicerida ispod 22,6 mmol/l nakon 3 mjeseca liječenja s 285 mg volanesorsena uz doziranje jednom tjedno.
English: The date you first remove the pack from the refrigerator should be recorded on the outer carton in the space indicated.
Croatian: Datum prvog vađenja pakiranja iz hladnjaka treba zabilježiti na vanjskoj kutiji na naznačenom prostoru.
English: In the volanesorsen group, of the 7 patients who had 24 adjudicated pancreatitis attacks in the prior 5 years, none of the patients experienced a pancreatitis attack during the 52 week treatment period.
Croatian: U skupini koja je primala volanesorsen, od 7 bolesnika koji su imali 24 događaja procijenjena kao napadaj pankreatitisa u prethodnih 5 godina, nijedan bolesnik nije iskusio napadaj pankreatitisa tijekom razdoblja liječenja od 52 tjedna.
English: This medicinal product is intended for subcutaneous use only.
Croatian: Ovaj lijek je namijenjen samo za supkutanu primjenu.
English: Arms - Back of upper area as shown (Figure F).
Croatian: Ruke - stražnje gornje dijelove kako je to prikazano (slika F).
English: The frequency of adverse reactions is defined using 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
Croatian: Učestalost nuspojava definirana je kako slijedi: 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
Croatian: Waylivra je indicirana kao dodatak dijeti u odraslih bolesnika s genetički potvrđenim sindromom obiteljske hilomikronemije (engl. familial chylomicronemia syndrome, FCS) koji su pod visokim rizikom od pankreatitisa te kod kojih je odgovor na dijetu i terapiju za snižavanje triglicerida neodgovarajući.
English: At a drug concentration 4.1 times the peak drug plasma concentrations (Cmax) of the maximum recommended dose (285 mg subcutaneous injection), volanesorsen did not prolong the heart-rate corrected QT (QTc) interval.
Croatian: Pri koncentraciji lijeka 4.1 puta većoj od vršnih plazmatskih koncentracija (Cmax) maksimalne preporučene doze (285 mg supkutana injekcija), volanesorsen nije produljio QT interval korigiran za brzinu srčanih otkucaja (QTc).
English: Do not recycle your used sharps disposal container.
Croatian: Nemojte reciklirati svoj spremnik s iskorištenim oštrim predmetima.
English: Treatment should also be discontinued for any clinical symptoms or signs of hepatic impairment or hepatitis.
Croatian: Liječenje također treba prekinuti u slučaju bilo kakvih kliničkih simptoma ili znakova oštećenja funkcije jetre ili hepatitisa.
English: Do not use Waylivra if the expiry date has passed or if it was stored for longer than 6 weeks at room temperature.
Croatian: Nemojte upotrebljavati Waylivru ako je istekao rok valjanosti ili ako je bila pohranjena dulje od 6
English: Do not stop using Waylivra unless you have discussed stopping your medicine with your doctor.
Croatian: Nemojte prekidati primjenu Waylivre dok to niste raspravili sa svojim liječnikom.
English: Remove the needle from the injection site by pulling out at the same angle it was inserted (Figure M).
Croatian: Izvadite iglu iz mjesta davanja injekcije izvlačenjem pod istim kutom pod kojim je bila umetnuta (slika M).
English: Urinary recovery of the parent drug was limited in humans with < 3% of administered subcutaneous dose recovered within 24 hours post dose.
Croatian: Količina nepromijenjenog lijeka u urinu u ljudi bila je ograničena na < 3% primijenjene supkutane doze nađene unutar 24 sata nakon doziranja.
English: Accumulation in Ctrough was observed (7- to 14-fold) and little or no increase in Cmax or AUC was observed following weekly SC administration over a dose of 200 to 400 mg.
Croatian: Uočena je akumulacija u Ctrough (7 do 14 puta) te malen ili nikakav porast za Cmax ili AUC nakon tjedne supkutane primjene u rasponu doza od 200 do 400 mg.
English: The recommended starting dose is 285 mg in 1.5 ml injected subcutaneously once weekly for 3 months.
Croatian: Preporučena početna doza je 285 mg u 1,5 ml injicirano supkutano jednom na tjedan tijekom 3 mjeseca.
English: When your sharps disposal container is almost full, you will need to follow your community guidelines for proper disposal of the sharps container.
Croatian: Kada je spremnik za zbrinjavanje oštrih predmeta skoro pun, morate se pridržavati lokalne smjernice o pravilnom zbrinjavanju spremnika s oštrim predmetima.