FrancophonIA/ELRC3.0 huggingface dataset:
English: If methadone oral solutions containing high molecular weight povidone (K90) are misused by injection instead of being taken by mouth as they are intended, the povidone accumulates inside vital organs and may cause serious harm, with possible fatal consequences.
Croatian: Ako se oralne otopine metadona koje sadrže providon visoke molekulske mase (K90) zlouporabe injekcijom umjesto da se uzimaju peroralno kao što je predviđeno, povidon se akumulira unutar stanica vitalnih organa što može uzrokovati ozbiljna oštećenja, s mogućim smrtnim posljedicama.
English: For methadone tablets containing povidone of lower molecular weight (e.g. K25 and K30), the available data showed that this kind of povidone is excreted from the body and does not accumulate inside the cells as high molecular weight povidone does.
Croatian: U slučaju tableta metadona koje sadrže povidon niže molekulske mase (primjerice K25 i K30), dostupni podaci su pokazali da se ova vrsta povidona izlučuje iz tijela te da se ne akumulira unutar stanica kao što je to u slučaju povidona visoke molekularne mase.
English: The PRAC assessed the available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone from post-marketing reports and the published literature, and a group of experts (which included pathologists and addiction experts) was consulted for advice.
Croatian: PRAC je ocijenio dostupne podatke o sigurnoj primjeni s obzirom na rizike povezane s zlouporabom injekcije lijekova metadona koji sadrže povidon iz postmarketinških izvještaja i objavljene literature, a zatražen je i savjet grupe stručnjaka (koja je uključivala patologe i stručnjake za ovisnost) . PRAC je zaključio da bi mjere smanjivanja rizika bile nedostatne za smanjivanje rizika povezanih s oralnim otopinama koje sadrže povidon visoke molekularne mase, te je stoga preporučio da se ovi proizvodi suspendiraju.
English: market and changes will be made to the product information (SmPC and package leaflet) to reinforce the message that tablets are for oral administration only and must not be taken in any other way.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom promijene će se primijeniti na informacije o proizvodu (SPC i uputu o lijeku) kako bi se naglasila poruka da su tablete samo za oralnu primjenu te da se ne smiju uzimati na drugi način.
English: • Upright and stable during use,
Croatian: • uspravan i stabilan tijekom uporabe,
English: Less than 50a, b
Croatian: Manje od 50a,b
English: Wash your hands thoroughly with soap (for at least 3 minutes) and dry them well.
Croatian: Temeljito operite ruke sapunom (barem 3 minute) i dobro ih osušite.
English: Do not inject more than one dose within 2 days.
Croatian: Nemojte injicirati više od jedne doze unutar 2 dana.
English: Date of first authorisation: 03 May 2019
Croatian: Datum prvog odobrenja: 03 svibnja 2019.
English: You may not know that you have this condition until this point, or what might have caused it.
Croatian: Možda dosad niste niti znali da imate ovo stanje ili što bi ga moglo uzrokovati.
English: % Change
Croatian: % Promjene
English: Starting dose: Weekly After 3 months: Every 2 weeks
Croatian: Početno doziranje: tjedno Nakon 3 mjeseca: svaka 2 tjedna
English: For all injections:
Croatian: Za sve injekcije:
English: It is recommended that you discuss breast-feeding with your doctor to see what is best for you and your child.
Croatian: Preporučuje se da o dojenju raspravite sa svojim liječnikom kako biste vidjeli što je najbolje za Vas i Vaše dijete.
English: A risk to the newborn infant cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: The decrease was gradual, self-sustaining and did not decrease to adverse levels.
Croatian: Smanjenje je bilo postupno, samoodrživo i nije se spustilo do štetnih razina.
English: 100 to 139
Croatian: 100 do 139
English: Your doctor will tell you how often you should take this medicine.
Croatian: Vaš će Vam liječnik reći koliko često morate primjenjivati ovaj lijek.
English: • Properly labeled to warn of hazardous waste inside the container.
Croatian: • Ispravno označen upozorenjem o opasnom otpadu koji sadrži.
English: Age, sex, weight, and race
Croatian: Dob, spol, težina i rasa
English: It is normal to see a large air bubble.
Croatian: Normalno je vidjeti veliki zračni mjehurić.
English: The safety and efficacy of this medicinal product in children and adolescents below 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost ovog lijeka u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: • The Guide for healthcare professionals shall contain the following key elements:
Croatian: • Vodič za zdravstvene radnike će sadržavati sljedeće ključne elemente:
English: - Medicines that may cause problems with your liver, such as paracetamol.
Croatian: - Lijekovi koji mogu uzrokovati probleme s Vašom jetrom, poput paracetamola.
English: Do not use Waylivra if you are under 18 years old.
Croatian: Ne uzimajte Waylivru ako ste mlađi od 18 godina.
English: Instructions for use are provided at the end of this leaflet.
Croatian: Upute za primjenu nalaze se na kraju ove upute.
English: 75 to 99
Croatian: 75 do 99
English: You should avoid alcohol during treatment with this medicine due to risk of liver issues.
Croatian: Morate izbjegavati alkohol tijekom liječenja ovim lijekom zbog rizika od oštećenja jetre.
English: * p-value =0.0001 **p-value < 0.0001
Croatian: * p-vrijednost = 0,0001 **p-vrijednost < 0,0001
English: This medicine is intended for patients aged 18 years and above.
Croatian: Ovaj lijek je namijenjen za bolesnike u dobi od 18 i više godina.
English: Before using this medicine, it is important that you read, understand, and closely follow the instructions for use.
Croatian: Prije uporabe ovog lijeka važno je da pročitate, shvatite i pomno se pridržavate uputa za primjenu.
English: Every 2-3 days
Croatian: Svaka 2 do 3 dana
English: If you miss a dose, contact your doctor to ask when to take your next dose.
Croatian: Ako propustite dozu, obratite se svom liječniku da biste pitali kada uzeti sljedeću dozu.
English: Please note that the expiry date refers to the last day of that month.
Croatian: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: The applicant will ensure the long term follow-up of patients in the Registry.
Croatian: Podnositelj zahtjeva će osigurati dugoročno praćenje bolesnika u Registru.
English: 3 years
Croatian: 3 godina.
English: Contents of the pack and other information What Waylivra contains
Croatian: Sadržaj pakiranja i druge informacije Što Waylivra sadrži
English: 50 to 74a
Croatian: 50 do 74a
English: If signs and symptoms of hepatotoxicity develop, use of the hepatotoxic medicinal product should be discontinued.
Croatian: Ako se razviju znakovi i simptomi hepatotoksičnosti, uporabu hepatotoksičnog lijeka treba prekinuti.
English: Ask your pharmacist or see your local public health government website (where available) for more details on how you should dispose of sharps in your location.
Croatian: Upitajte svog ljekarnika ili provjerite internetsku stranicu svoje lokalne uprave (ako je dostupno) za više pojedinosti o tome kako morate zbrinuti oštre predmete u svom mjestu stanovanja.
English: You may notice this if you have an injury which causes bleeding and it takes a long time to stop (more than 5-6 minutes for a skin scratch).
Croatian: Možda ste uočili da Vam je u slučaju ozljedu koja uzrokuje krvarenje potrebno puno vremena da krvarenje prestane (više od 5 do 6 minuta za ogrebotinu na koži).
English: Do not warm syringe in any other way, such as by microwave or warm water.
Croatian: Nemojte koristiti druge načine zagrijavanja štrcaljke poput mikrovalne pećnice ili tople vode.
English: It is normal to see a large air bubble (Figure D).
Croatian: Normalno je vidjeti veliki zračni mjehurić (slika D).
English: With treatment with Waylivra, LDL-C levels may rise but will usually remain within the normal range.
Croatian: S liječenjem lijekom Waylivra, razine LDL-C mogu se povisiti ali obično ostaju unutar normalnog raspona.
English: What Waylivra is and what it is used for
Croatian: Što je Waylivra i za što se koristi
English: b) Post heparin plasma LPL activity of ≤ 20% of normal.
Croatian: b) Postheparinska LPL aktivnost plazme ≤ 20% normalne vrijednosti.
English: No overall differences in safety or effectiveness were observed between these patients and younger patients, however data are limited in this subpopulation.
Croatian: Nisu uočene ukupne razlike u sigurnosti ili djelotvornosti između ovih i mlađih bolesnika, međutim podaci su ograničeni u ovoj podpopulaciji.
English: If 1 visit was missing, then the other visit was used as the endpoint.
Croatian: Ako je jedan posjet propušten, onda je drugi posjet korišten kao mjera ishoda.
English: You should refer to the date you have written on the carton to be sure.
Croatian: Pogledajte datum koji ste zapisali na kutiji kako biste bili sigurni.
English: Waylivra with alcohol
Croatian: Waylivra s alkoholom
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarniku.
English: Get ready to inject 1.
Croatian: Pripremite se za injiciranje 1.
English: Date of first removal from fridge:
Croatian: Datum prvog vađenja iz hladnjaka:
English: There were no adverse events related to drug-drug interactions reported during the clinical program, however this is based on limited data.
Croatian: Nije bilo štetnih događaja povezanih s interakcijama lijek-lijek, a koje su prijavljene tijekom kliničkog programa, međutim to se temelji na ograničenim podacima.
English: Effects of Waylivra on lipid parameters
Croatian: Učinci Waylivre na lipidne parametre
English: There is limited clinical data for patients aged 65 and over (see sections 5.1 and 5.2).
Croatian: Klinički podaci za bolesnike u dobi od 65 i više godina ograničeni su (vidjeti dijelove 5.1 i 5.2).
English: These local reactions were mostly mild and typically consisted of 1 or more of the following: erythema, pain, pruritus, or local swelling.
Croatian: Te lokalne reakcije bile su uglavnom blage i obično su se sastojale od 1 ili više sljedećih znakova i simptoma: eritema, boli, pruritusa ili lokalnog oticanja.
English: c The denominator for percentage calculation was the total number of patients in each treatment group.
Croatian: c Nazivnik za izračun postotka bio je ukupan broj bolesnika u svakoj skupini za liječenje.
English: What Waylivra looks like and contents of the pack
Croatian: Kako Waylivra izgleda i sadržaj pakiranja
English: If you do not have a sharps disposal container, you may use a household container that is:
Croatian: Ako nemate spremnik za zbrinjavanje oštrih predmeta, možete upotrijebiti spremnik za kućni otpad koji je:
English: If you use more Waylivra than you should
Croatian: Ako primijenite više Waylivre nego što ste trebali
English: Talk to your healthcare provider if you are unsure of where to inject.
Croatian: Razgovarajte sa svojim zdravstvenim radnikom ako niste sigurni na koje si mjesto morate dati injekciju.
English: The needle should be inserted at a 45 degree angle to the skin surface (Figure J).
Croatian: Iglu treba umetnuti pod kutom od 45 stupnjeva u odnosu na površinu kože (slika J).
English: The most recent data of the ongoing Study CS7 is provided in Table 6.
Croatian: Najnoviji podaci ispitivanja CS7 koje je u tijeku, prikazani su u Tablici 6.
English: Normal (≥140)
Croatian: Normalno (> 140 )
English: The effect of concomitant administration of this medicinal product with alcohol or medicinal products known to have potential for hepatotoxicity (e.g., paracetamol) is unknown.
Croatian: Učinak istodobne primjene ovog lijeka s alkoholom ili lijekovima za koje se zna da imaju potencijal za hepatotoksičnost (npr. paracetamol) nije poznat.
English: No starting dose adjustment is necessary for elderly patients.
Croatian: Nije potrebna prilagodba početnog doziranja za starije bolesnike.
English: Remove the syringe and inspect the medicine
Croatian: Izvadite štrcaljku i pregledajte lijek
English: Always keep your sharps container away from children and pets.
Croatian: Uvijek držite svoj spremnik s oštrim predmetima podalje od djece i kućnih ljubimaca.
English: Store in a refrigerator (2 ° - 8 °C).
Croatian: Čuvati u hladnjaku (2 °C - 8 °C).
English: Relative Difference in Change vs Placebo
Croatian: Relativna razlika u promjeni naspram placeba
English: Do not use Waylivra until you completely understand the procedure described below.
Croatian: Nemojte upotrebljavati lijek Waylivru dok niste u potpunosti shvatili postupak opisan u nastavku.
English: Treatment and monitoring should be adjusted according to laboratory values in line with Table 1.
Croatian: Liječenje i praćenje treba prilagoditi prema laboratorijskim nalazima u skladu s Tablicom 1.
English: The concentrations in breast milk of mice were >800 fold lower than effective tissue concentrations in maternal liver.
Croatian: Koncentracije u mlijeku ženki miševa bile se > 800 puta niže od efektivne koncentracije u tkivu maternalne jetre.
English: It should be removed from refrigerated storage (2 ° to 8 °C) at least 30 minutes before use.
Croatian: Treba je izvaditi iz hladnjaka (2 do 8 °C) barem 30 minuta prije uporabe.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenicity or toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: Allow the injection to reach to room temperature
Croatian: Pustite da injekcija dosegne sobnu temperaturu
English: Elimination involves both metabolism in tissues and excretion in urine.
Croatian: Eliminacija uključuje i metabolizam u tkivima i izlučivanje u urinu.
English: Pharmacotherapeutic group:{Not yet assigned}, ATC code: {Not yet assigned} Mechanism of action
Croatian: Farmakoterapijska skupina:{nije još dodijeljena}, ATK oznaka: {nije još dodijeljena}
English: You or your caregiver will be trained on how to use Waylivra according to the instructions in this leaflet.
Croatian: Vas ili Vašeg njegovatelja će se obučiti kako upotrebljavati Waylivru u skladu s uputama u ovoj uputi o lijeku.
English: Call your doctor or pharmacist to get a new supply.
Croatian: Nazovite svog liječnika ili ljekarnika kako biste dobili novo pakiranje.
English: Following subcutaneous administration, terminal elimination half-life is approximately 2 to 5 weeks.
Croatian: Nakon supkutane primjene, terminalni poluvijek eliminacije je približno 2 do 5 tjedna.
English: Place the following items on a clean, flat surface in a well-lit area (Figure A).
Croatian: Postavite sljedeće predmete na dobro osvijetljenom području na čistoj, ravnoj površini (slika A).
English: The effect of taking Waylivra with alcohol is not known.
Croatian: Učinak uzimanja lijeka Waylivra s alkoholom nije poznat.
English: Waylivra has not been studied in patients under 18 years old.
Croatian: Waylivra nije ispitivana u bolesnika mlađih od 18 godina.
English: If you inject too much Waylivra, contact your doctor or pharmacist, or attend a hospital emergency department immediately, even if there are no symptoms.
Croatian: Ako injicirate previše Waylivre, obratite se svom liječniku ili ljekarniku ili odmah otiđite u hitnu službu čak i ako nemate simptoma.
English: Nineteen of the 33 patients in the volanesorsen group completed 12 months of study treatment.
Croatian: Devetnaest od 33 bolesnika u skupini koja je primala volanesorsen dovršilo je 12 mjeseci ispitivanog liječenja.
English: Other medicines and Waylivra
Croatian: Drugi lijekovi i Waylivra
English: Mean body mass index was 25 kg/m2.
Croatian: Prosječni indeks tjelesne mase iznosio je 25 kg/m2.
English: May be kept at room temperature for up to 6 weeks.
Croatian: Može se čuvati na sobnoj temperaturi do 6 tjedana.
English: Do not administer intramuscularly or intravenously.
Croatian: Nemojte primjenjivati intramuskularno ili intravenski.
English: Thighs - Front, middle area as shown (Figure E).
Croatian: Bedra - prednji, srednji dio kako je prikazano (slika E).
English: If administering an injection to someone else as a caregiver, in addition to the above sites:
Croatian: Ako dajete injekciju nekome drugome kao njegovatelj, pored prethodno spomenutih mjesta možete koristiti i:
English: Patients taking Glybera within 2 years prior to screening were excluded from the study.
Croatian: Bolesnici koji su uzimali lijek Glybera unutar 2 godine prije probira isključeni su iz ispitivanja.
English: You may see a drop of liquid at the tip of the needle.
Croatian: Možete vidjeti kapljicu tekućine na vrhu igle.
English: It may be necessary to consult a doctor specialising in blood disorders to determine whether you should continue treatment with Waylivra or not.
Croatian: Možda ćete se morati obratiti liječniku specijalisti za poremećaje krvi kako bi se odredilo trebate li nastaviti terapiju lijekom Waylivra ili ne.
English: You may also apply ice to the injection site to reduce pain, redness, or discomfort (Figure P).
Croatian: Možete također staviti led na mjesto injekcije kako biste smanjili bol, crvenilo ili nelagodu (slika P).
English: The absolute bioavailability of volanesorsen following a single subcutaneous administration is approximately 80% (most likely higher because an AUC of 0 to 24 hours was used and volanesorsen has a half-life of >2 weeks).
Croatian: Apsolutna bioraspoloživost volanesorsena nakon jednokratne supkutane primjene je približno 80% (najvjerojatnije viša zato jer je korišten AUC od 0 do 24 sata i volanesorsen ima poluvijek od > 2 tjedna).
English: Insert the needle into the injection site with a quick, firm motion without touching the plunger head.
Croatian: Umetnite iglu na mjesto injekcije brzim, čvrstim pokretom bez dodirivanja glave klipa.
English: Lipid Parameter (g/L for apoC-III, apoB, apoB-48; mmol/L for cholesterol, triglycerides)
Croatian: Lipidni parametar (g/l za apoC-III, apoB, apoB-48; mmol/l za kolesterol i trigliceride)
English: Unchanged volanesorsen is the predominant circulating component.
Croatian: Nepromijenjeni volanesorsen je prevladavajuća komponenta u krvotoku.
English: Patients should be instructed to give the injection on the same day of the week, according to medically determined frequency of administration.
Croatian: Bolesnike treba uputiti da si daju injekciju na isti dan u tjednu, prema učestalosti primjene koju je odredio liječnik.
English: There are limited data available in subjects >75 years of age.
Croatian: U ispitanika starijih od 75 godina dostupni su ograničeni podaci.
English: This can lead to inflammation of your pancreas, causing severe pain.
Croatian: To može dovesti do upale gušterače što uzrokuje tešku bol.
English: In animals, elimination of volanesorsen was slow and occurred mainly via urinary excretion, reflecting rapid plasma clearance principally to tissues.
Croatian: Kod životinja je eliminacija volanesorsena bila spora i događala se uglavnom izlučivanjem urinom što je odražavalo brzi plazmatski klirens uglavnom prema tkivima.
English: Waylivra should be inspected visually prior to administration.
Croatian: Waylivru treba pregledati vizualno prije primjene.
English: Your doctor may also do a blood test every 3 months to check for signs of damage to your liver.
Croatian: Vaš liječnik može također provoditi krvne pretrage svaka 3 mjeseca kako bi provjerio ima li znakova oštećenja jetre.
English: Haemodialysis is unlikely to be beneficial given that volanesorsen is rapidly distributed into cells.
Croatian: Nije vjerojatno da će hemodijaliza biti korisna s obzirom da se volanesorsen ubrzano distribuira u stanice.
English: The median age at diagnosis was 27 years, with 23% shown to lack a known FCS genetic mutation.
Croatian: Medijan dobi pri dijagnozi iznosio je 27 godina, a za 23% bolesnika pokazalo se da nemaju poznatu genetičku mutaciju FSC-a.
English: No clinical data on the effect of this medicinal product on human fertility are available.
Croatian: Nisu dostupni klinički podaci o učinku ovog lijeka na plodnost u ljudi.
English: Thirteen of these patients had dose adjustment/pause on the study.
Croatian: Trinaest od tih bolesnika imali su prilagodbu doziranja/pauzu u doziranju tijekom ispitivanju.
English: The safety and efficacy in patients with severe renal impairment has not been established and these patients should be closely observed.
Croatian: Sigurnost i djelotvornost u bolesnika s teškim oštećenjem funkcije bubrega nije utvrđena i te bolesnike treba pomno pratiti.
English: You will only be given Waylivra if genetic testing has confirmed you have FCS and your risk for pancreatitis is considered very high..
Croatian: Primit ćete Waylivru samo ako genetičko testiranje potvrdi da imate FSC te da ste pod vrlo visokim rizikom od pankreatitisa.
English: No evidence of altered safety profile or clinical response was associated with presence of anti-drug antibodies; however this is based on the limited long-term data (see section 4.4).
Croatian: Nema dokaza o promijenjenom sigurnosnom profilu ili kliničkom odgovoru koji bi bili povezani s prisutnošću protutijela na lijek, međutim to se temelji na ograničenim dugoročnim podacima (vidjeti dio 4.4).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from 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 Waylivra uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: If injected in the upper arm, the injection should be administered by another person.
Croatian: Ako se daje u nadlakticu, injekciju treba dati druga osoba.
English: You should continue the very low-fat diet that your doctor has prescribed during treatment with Waylivra.
Croatian: Morate nastaviti s dijetom s niskom sadržajem masnoća koju Vam je liječnik propisao tijekom liječenja Waylivrom.
English: Recommendations for adjustments to monitoring frequency and dosing are specified in Table 1 (see section 4.2).
Croatian: Preporuke za prilagodbe učestalosti praćenja i doziranja navedene su u Tablici 1 (vidjeti dio 4.2).
English: The selective binding of volanesorsen to the apoC-III messenger ribonucleic acid (mRNA) within the 3′ untranslated region at base position 489-508 causes the degradation of the mRNA.
Croatian: Selektivno vezivanje volanesorsena na glasničku ribonukleinsku kiselinu za apoC-III (mRNK) unutar regije koja se ne prevodi na 3´ kraju, na položaju 489.-508. baze uzrokuje degradaciju mRNK.
English: You can reduce the likelihood of having injection site reaction if you wait for Waylivra to reach room temperature before injecting, and by applying ice to the injection site after injecting.
Croatian: Možete smanjiti vjerojatnost nastanka reakcije na mjestu injekcije ako pričekate da Waylivra dosegne sobnu temperaturu prije injiciranja i potom nakon injiciranja primijenite led na mjesto injiciranja.
English: In vitro studies indicate that volanesorsen is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 or inducer of CYP1A2, CYP2B6, or CYP3A4.
Croatian: In vitro ispitivanja pokazuju da volanesorsen nije inhibitor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, ili CYP3A4 ili induktor CYP1A2, CYP2B6, ili CYP3A4.
English: Volanesorsen had no effect on fertility in mice.
Croatian: Volanesorsen nije imao učinka na plodnost u miševa.
English: In clinical studies, this medicinal product has been used in combination with fibrates and fish oils with no impact on the medicinal product pharmacodynamics or pharmacokinetics.
Croatian: U kliničkim ispitivanjima ovaj je lijek upotrebljavan u kombinaciji s fibratima i ribljim uljima bez utjecaja na njegovu farmakodinamiku ili farmakokinetiku.
English: Parameter at Month 3a
Croatian: Parametar u 3. mjesecua