FrancophonIA/ELRC3.0 huggingface dataset:
English: Posology and administration are the same as for adults 18 to 64 years of age.
Croatian: Doziranje i primjena jednaki su za odrasle u dobi od 18 do 64 godine.
English: The dose should be administered at approximately the same time each day.
Croatian: Dozu treba primijeniti približno u isto vrijeme svaki dan.
English: Treatment with Kineret resulted in normalization of body temperature in 18 of 20 patients.
Croatian: Liječenje Kineretom dovelo je do normalizacije tjelesne temperature u 18 od 20 bolesnika.
English: Where should you give your injection?
Croatian: Gdje si morate dati injekciju?
English: When you start taking Kineret the chronic inflammation in your body will decrease.
Croatian: Nakon što počnete uzimati Kineret, kronična upala u Vašem tijelu će se smanjiti.
English: At the end of this period, the product must not be put back in the refrigerator and must be disposed of.
Croatian: Pri kraju ovog razdoblja lijek se ne smije vratiti natrag u hladnjak te ga treba baciti.
English: The plasma concentration decreased with no discernible distribution phase and the terminal half-life ranged from 4 to 6 hours.
Croatian: Koncentracije u plazmi smanjile su se bez jasne faze distribucije, a završni poluvijek bio je u rasponu od 4 do 6 sati.
English: However, you should contact your doctor, nurse or pharmacist if this does happen.
Croatian: Međutim, morate se obratiti svom liječniku, medicinskoj sestri ili ljekarniku ako se to dogodi.
English: This was not associated with any clinically significant effects on pharmacokinetics, efficacy, or safety.
Croatian: To nije ni na koji način imalo klinički značajan učinak na farmakokinetiku, djelotvornost ili sigurnost.
English: If you are not able to set the correct dose, dispose of the syringe and use a new one.
Croatian: Ako niste uspjeli odrediti ispravnu dozu, bacite štrcaljku i upotrijebite novu.
English: Contents of the pack and other information What Kineret contains
Croatian: Sadržaj pakiranja i druge informacije Što Kineret sadrži
English: This treatment combination has not demonstrated increased clinical benefit.
Croatian: Ova kombinacija liječenja nije pokazala povećanu kliničku korist.
English: In observations up to 3 years, the serious infection rate remained stable over time.
Croatian: U promatranjima koja su provođena do 3 godine, stopa ozbiljnih infekcija ostala je stabilna tijekom vremena.
English: - Serious allergic reactions are uncommon.
Croatian: - Ozbiljne alergijske reakcije su manje česte.
English: Before you inject Kineret you must do the following:
Croatian: Prije injiciranja Kinereta morate napraviti sljedeće:
English: None of these patients had serious infections associated with the neutropenia.
Croatian: Nijedan od ovih bolesnika nije imao ozbiljnu infekciju povezanu s neutropenijom.
English: For instructions on how to inject yourself or your child with Kineret, please read the “Instructions for preparing and giving an injection of Kineret” section at the end of this leaflet.
Croatian: Za upute o tome kako sami sebi ili svom djetetu možete injicirati Kineret molimo pročitajte dio „Upute za pripremu i primjenu injekcije Kinereta“ na kraju ove upute.
English: Change the place that you inject each time so you don't become sore in one area.
Croatian: Promijenite mjesto injiciranja svaki put tako da ne postane bolno u jednom području.
English: Put the needle fully into the skin as shown by your nurse or doctor.
Croatian: Uvedite iglu pod kožu kako su Vam to pokazali medicinska sestra ili liječnik.
English: Do not use it if the date has passed the last day of the month shown.
Croatian: Nemojte je primijeniti ako je prošao datum posljednjeg dana mjeseca navedenog na naljepnici.
English: Maintenance dose in severe CAPS (MWS and NOMID/CINCA)
Croatian: Doza održavanja kod teškog CAPS-a (MWS i NOMID/CINCA)
English: The majority of these reactions were maculopapular or urticarial rashes.
Croatian: Većina ovih reakcija bili su makulopapularni ili urtikarijski osipi.
English: You can now use the pre-filled syringe as described in the “Where should you give your injection?” section and “How do you give your injection?” section.
Croatian: Sada napunjenu štrcaljku možete primijeniti kako je opisano u odjeljcima „Gdje si morate dati injekciju?“ i „Kako ćete si dati injekciju?“.
English: The main objectives of the programme are to provide information on the method of administration, raise awareness on the potential risk of macrophage activation syndrome (MAS) and on the potential risk of serious infections.
Croatian: Glavni ciljevi programa su pružanje informacija o načinu primjene, podizanje svijesti o mogućem riziku od sindroma aktivacije makrofaga (MAS) i o mogućem riziku od ozbiljnih infekcija.
English: RA: No dose adjustment is required.
Croatian: RA: Nije potrebna prilagodba doze.
English: Allow the pre-filled syringe to reach room temperature before injecting.
Croatian: Omogućiti da napunjena štrcaljka postigne sobnu temperaturu prije injiciranja.
English: In addition, postmarketing adverse event reports and published studies constitute supporting data.
Croatian: Nadalje, postmarketinški prijavljeni štetni događaji i objavljena ispitivanja potvrđuju podatke.
English: The majority (95%) of ISRs were reported as mild to moderate.
Croatian: Većina (95%) ISR bila je prijavljena kao blaga do umjerena.
English: It is important that you do not try to give yourself or your child the injection unless you have received training from a doctor, nurse or pharmacist.
Croatian: Važno je da ne pokušavate sami sebi ili svom djetetu dati injekciju osim ako Vas liječnik, medicinska sestra ili ljekarnik nisu za to obučili.
English: - CAPS: Kineret is not recommended for children younger than 8 months of age because there is no data in this age group.
Croatian: - CAPS: Primjena Kinereta u djece mlađe od 8 mjeseci se ne preporučuje jer nema podataka za tu dobnu skupinu.
English: • Never put the pre-filled syringes that you have used into your normal household rubbish bin.
Croatian: • Nemojte nikada stavljati iskorištenu napunjenu štrcaljku u Vaš uobičajeni kućni otpad.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak vezano uz reproduktivnu toksičnost (vidjeti dio 5.3).
English: Rheumatoid Arthritis (RA)
Croatian: Reumatoidni artritis (RA)
English: In children with inadequate response the dose can be escalated up to 4 mg/kg/day.
Croatian: U djece s neodgovarajućim odgovorom doza se može povećati do 4 mg/kg/dan.
English: You will need to give yourself or your child an injection at the same time every day.
Croatian: Injekciju sebi ili svom djetetu morate davati svaki dan u isto vrijeme.
English: These symptoms are generally mild to moderate and are more common at the start of your treatment.
Croatian: Ti simptomi su općenito blagi do umjereni te su češći na početku Vašeg liječenja.
English: You do not have to remove the air bubble before injecting.
Croatian: Ne morate ukloniti mjehurić zraka prije injiciranja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kineret in one or more subsets of the paediatric population in CAPS and RA (JIA) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Kineret u jednoj ili više podskupina pedijatrijske populacije za CAPS i RA (JIA) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: With the exception of infections and related symptoms that were more frequently reported in patients <2 years of age, the safety profile was similar in all paediatric age groups.
Croatian: Osim infekcija i povezanih simptoma koji su češće prijavljivani u ispitanika u dobi <2 godine, sigurnosni profil bio je sličan u svim pedijatrijskim dobnim skupinama.
English: Kineret is for patients whose response to methotrexate on its own is not good enough to control the rheumatoid arthritis.
Croatian: Kineret je namijenjen bolesnicima čiji odgovor na sam metotreksat nije dovoljno dobar za kontrolu reumatoidnog artritisa.
English: Do not remove the cover from the syringe until you are ready to inject.
Croatian: Nemojte uklanjati pokrov sa štrcaljke dok niste spremni injicirati.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Croatian: Ako imate problema, nemojte se bojati pitati liječnika ili medicinsku sestru za pomoć ili savjet.
English: During an open-label extension phase, switching or add-on treatment with the comparator drug was possible if improvement did not occur within 24 weeks.
Croatian: Tijekom faze otvorenog nastavka ispitivanja bilo je omogućeno prebacivanje na usporedni lijek ili dodatno liječenje usporednim lijekom ako poboljšanje nije nastupilo unutar 24 tjedna.
English: If you have forgotten to take a dose of Kineret, you should contact your doctor to discuss when you should take the next dose.
Croatian: Ako ste zaboravili primijeniti dozu Kinereta, obratite se svom liječniku kako biste dobili savjet o tome kada trebate primijeniti sljedeću dozu.
English: Other medicines and Kineret
Croatian: Drugi lijekovi i Kineret
English: Inject the liquid slowly and evenly, always keeping the skin pinched as in Figure E.
Croatian: Injicirajte tekućinu polako i ravnomjerno, držeći nabor kože cijelo vrijeme kako je prikazano na slici E.
English: Maximal clinical response was generally seen within 12 weeks after starting treatment.
Croatian: Maksimalni klinički odgovor općenito je primijećen unutar 12 tjedana nakon početka liječenja.
English: Less than 2.5% of the administered dose of Kineret was removed by hemodialysis or continuous ambulatory peritoneal dialysis.
Croatian: Manje od 2,5% primijenjene doze Kinereta uklonjeno je hemodijalizom ili kontinuiranom ambulantnom peritonejskom dijalizom.
English: Response to treatment should be evaluated after 1 month: In case of persistent systemic manifestations dose may be adjusted in children or continued treatment with Kineret should be reconsidered by the treating physician.
Croatian: Odgovor na liječenje treba procijeniti nakon 1 mjeseca: u slučaju i dalje prisutnih sistemskih manifestacija, dozu se u djece može prilagoditi ili ordinirajući liječnik treba ponovno razmotriti nastavak liječenja Kineretom.
English: This results in harmful effects leading to inflammation, causing the symptoms of the disease.
Croatian: To rezultira u štetnim učincima koji uzrokuju upalu, te dolazi do pojave simptoma bolesti.
English: Non-infectious hepatitis
Croatian: Neinfektivni hepatitis
English: ISRs typically appear within 2 weeks of therapy and disappear within 4-6 weeks.
Croatian: ISR se tipično javljaju unutar 2 tjedna liječenja i povlače unutar 4 do 6 tjedana.
English: Kineret has not been tested in pregnant women.
Croatian: Kineret nije ispitan na trudnicama.
English: Placebo treatment (n=213) resulted in a decrease of approximately 2.2% in total cholesterol levels at week 2 and 2.3% at week 24.
Croatian: Kod liječenja placebom (n=213) došlo je do smanjenja razine ukupnog kolesterola za približno 2,2% u 2. tjednu i za 2,3% u 24. tjednu.
English: This could mean that the doses of some other medicines, e.g. warfarin or phenytoin, have to be adjusted.
Croatian: To znači da će možda biti potrebno prilagoditi dozu nekih drugih lijekova, primjerice varfarina ili fenitoina.
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC03
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC03 Mehanizam djelovanja
English: - Headaches.
Croatian: - Glavobolje.
English: One out of the 15 patients discontinued due to ISRs.
Croatian: Jedan od 15 bolesnika prekinuo je liječenje zbog ISR.
English: RA: The efficacy of Kineret in children with RA (JIA) aged 0 to 18 years has not been established.
Croatian: RA: Djelotvornost Kinereta u djece s RA (juvenilnim idiopatskim artritisom, JIA) u dobi od 0 do 18 godina nije ustanovljena.
English: Long-term studies have not been performed to evaluate the carcinogenic potential of anakinra.
Croatian: Nisu provedena dugoročna ispitivanja za procjenu kancerogenog potencijala anakinre.
English: Eleven serious events in 4 (9.3%) patients were considered related to Kineret.
Croatian: Smatra se da je jedanaest ozbiljnih događaja u 4 (9,3%) bolesnika bilo povezano s
English: Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating elderly patients.
Croatian: S obzirom na povećanu incidenciju infekcija u starije populacije općenito, u liječenju starijih bolesnika potreban je oprez.
English: Interactions between Kineret and other medicinal products have not been investigated in formal studies.
Croatian: Interakcije između Kinereta i drugih lijekova nisu ispitane u službenim studijama.
English: The safety of Kineret in individuals with latent tuberculosis is unknown.
Croatian: Sigurnost Kinereta u osoba s latentnom tuberkulozom nije poznata.
English: The usual maintenance dose in severe CAPS is 3-4 mg/kg/day, which can be adjusted to a maximum of 8 mg/kg/day.
Croatian: Uobičajena doza održavanja kod teškog CAPS-a iznosi 3-4 mg/kg/dan, a može se prilagoditi do maksimalno 8 mg/kg/dan.
English: What Kineret looks like and contents of the pack
Croatian: Kako Kineret izgleda i sadržaj pakiranja
English: How do you give your injection?
Croatian: Kako ćete si dati injekciju?
English: Most patients continued on study medicinal product after the infection resolved.
Croatian: Većina bolesnika nastavljala je uzimati ispitivani lijek nakon povlačenja infekcije.
English: There have been reports of tuberculosis in patients receiving several biological anti-inflammatory treatment regimens.
Croatian: Zabilježeni su slučajevi tuberkuloze u bolesnika koji primaju nekoliko bioloških protuupalnih režima liječenja.
English: Do not try to inject yourself if you have not been trained.
Croatian: Nemojte pokušavati injicirati lijek sami sebi ako niste obučeni u tome.
English: However, after adjusting for creatinine clearance and body weight, gender and age were not significant factors for mean plasma clearance.
Croatian: Međutim, nakon prilagodbe na klirens kreatinina i tjelesnu težinu, spol i dob nisu bili značajni čimbenici za prosječni klirens u plazmi.
English: Pharmacokinetic parameters were not substantially different from healthy volunteers, other than a decrease in clearance of approximately 30% in comparison with data from a study with healthy volunteers.
Croatian: Farmakokinetički se parametri nisu značajno razlikovali od onih u zdravih dobrovoljaca, osim približno 30% slabijeg klirensa u usporedbi sa zdravim dobrovoljcima.
English: The occurrence of antibodies was typically transient and not associated with clinical adverse reactions or diminished efficacy.
Croatian: Pojava protutijela bila je tipično prolazna i nije bila povezana s kliničkim nuspojavama ili smanjenjem djelotvornosti.
English: What should you do before you give yourself or your child a subcutaneous injection of Kineret?
Croatian: Što morate učiniti prije nego sebi ili svom djetetu date potkožnu injekciju Kinereta?
English: How to prepare a 100 mg dose
Croatian: Kako pripremiti dozu od 100 mg
English: You should try to have the injection at the same time each day.
Croatian: Pokušajte primijeniti injekciju svaki dan u isto vrijeme.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25 °C) it must either be used within 12 hours or disposed of.
Croatian: Nakon što ste izvadili štrcaljku iz hladnjaka te nakon što je postigla sobnu temperaturu (do 25 °C) mora se ili primijeniti unutar 12 sati ili baciti.
English: At 1 year follow-up, 18 of 20 patients showed at least an adapted ACRpedi 70 response, and 17 of 20 patients reached an adapted ACRpedi 90 response as well as inactive disease.
Croatian: 1 godine praćenja, 18 od 20 bolesnika pokazalo je barem prilagođen odgovor ACRpedi70, dok se u 17 od 20 bolesnika postigao prilagođen odgovor ACRpedi90, kao i neaktivnost bolesti.
English: After injecting the liquid, remove the needle and let go of the skin.
Croatian: Nakon injiciranja tekućine, izvucite iglu i opustite kožu.
English: You may notice a small air bubble in the pre-filled syringe.
Croatian: Možete primijetiti mjehurić zraka u napunjenoj štrcaljki.
English: Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI).
Croatian: Anakinra neutralizira biološku aktivnost interleukina-1α (IL-1α) i interleukina-1β (IL-1β) kompetitivnom inhibicijom njihova vezivanja na receptor interleukina1 tipa I (IL-1RI).
English: Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes.
Croatian: Veličine pakiranja od 1, 7 ili 28 (višestruko pakiranje koje sadrži 4 pakiranja od 7 napunjenih štrcaljki) napunjenih štrcaljki.
English: Take your Kineret pre-filled syringe out of the refrigerator.
Croatian: Izvadite napunjenu štrcaljku Kinereta iz hladnjaka.
English: Immunogenicity See section 4.8.
Croatian: Imunogenost Vidjeti dio 4.8.
English: Turn the syringe so that the needle is now pointing downwards.
Croatian: Okrenite štrcaljku tako da igla bude usmjerena prema dolje.
English: • Information on macrophage activation syndrome (MAS) in patients receiving the product for the treatment of Still's disease
Croatian: • Informacije o sindromu aktivacije makrofaga (MAS) u bolesnika koji lijek primaju za liječenje Stillove bolesti
English: The development of ISRs in patients who had not previously experienced ISRs was uncommon after the first month of therapy.
Croatian: Razvoj ISR u bolesnika koji nisu prethodno imali reakcije bio je manje čest nakon prvog mjeseca terapije.
English: Juvenile rats treated at doses up to 100 times the human dose from day 7 postparturition up to adolescence did not show any signs of adverse effects of the treatment.
Croatian: Mladi štakori liječeni dozama do 100 puta većima od doze za ljude od 7. dana nakon okota sve do adolescentne dobi nisu pokazali nikakve znakove nuspojava liječenja.
English: The risk for developing MAS is increased if you have an infection or if your Still's disease symptoms are poorly controlled.
Croatian: Rizik za pojavu MAS-a veći je ako imate infekciju ili ako su Vam simptomi Stillove bolest slabo kontrolirani.
English: Routine testing of hepatic enzymes during the first month should be considered, especially if the patient has pre-disposing factors or develops symptoms indicating liver dysfunction.
Croatian: Treba razmotriti rutinsko praćenje jetrenih enzima tijekom prvog mjeseca liječenja, posebice ako bolesnik ima predisponirajuće čimbenike ili razvije simptome koji upućuju na disfunkciju jetre.
English: In a standard battery of tests designed to identify hazards with respect to DNA, anakinra did not induce bacterial or mammalian cell gene mutations.
Croatian: U standardnim baterijama testova namijenjenim identifikaciji opasnosti obzirom na DNK, anakinra nije inducirala mutacije gena stanica bakterija ili sisavaca.
English: - if you get a rash all over your body, shortness of breath, wheezing, fast pulse or sweating after your Kineret injection.
Croatian: - ako dobijete osip po cijelom tijelu, imate nedostatak zraka, piskanje, ubrzani puls ili se znojite nakon injekcije Kinereta.
English: Hepatic Events
Croatian: Hepatički događaji
English: If you forget to use Kineret
Croatian: Ako ste zaboravili primijeniti Kineret
English: Kineret is injected just under the skin.
Croatian: Kineret se injicira odmah pod kožu.
English: Safety in paediatric RA (JIA) patients
Croatian: Sigurnost u pedijatrijskih bolesnika s RA (JIA)
English: If a severe allergic reaction occurs, administration of Kineret should be discontinued and appropriate treatment initiated.
Croatian: U slučaju teške alergijske reakcije, primjenu Kinereta treba prekinuti i započeti s odgovarajućim liječenjem.
English: For a more comfortable injection, leave at room temperature for approximately 30 minutes or hold the pre-filled syringe gently in your hand for a few minutes.
Croatian: Kako bi sama injekcija bila manje nelagodna, ostavite napunjenu štrcaljku na sobnoj temperaturi približno 30 minuta ili je oprezno držite u ruci tijekom nekoliko minuta.
English: Cooling of the injection site, warming the injection liquid to room temperature, use of cold packs (before and after the injection), and use of topical glucocorticoids and antihistamines after the injection can alleviate the signs and symptoms of injection site reactions.
Croatian: Hlađenje mjesta primjene, zagrijavanje injekcijske tekućine do sobne temperature, uporaba hladnih obloga (prije i nakon primjene) i topikalna primjena glukokortikoida i antihistaminika nakon primjene mogu ublažiti znakove i simptome reakcija na mjestu primjene.
English: At Week 24, 6 of 12 patients on anakinra were in remission versus 2 of 10 patients on DMARDs.
Croatian: U 24. tjednu, 6 od 12 bolesnika na anakinri bilo je u remisiji naspram 2 od 10 bolesnika na DMARD-ovima.
English: In clinical studies and during post-marketing use, rare cases of opportunistic infections have been observed and have included fungal, mycobacterial, bacterial, and viral pathogens.
Croatian: U kliničkim ispitivanjima i tijekom postmarketinške primjene primijećene su u rijetkim slučajevima oportunističke infekcije koje su uključivale gljivične, mikobakterijske, bakterijske i virusne patogene.
English: - RA: Use of Kineret in children and adolescents with Rheumatoid Arthritis has not been fully investigated and therefore cannot be recommended.
Croatian: - RA: Primjena Kinereta u djece i adolescenata s reumatoidnim artritisom nije do kraja ispitana te se stoga ne preporučuje.
English: Upon start or end of Kineret treatment in patients on these types of medicinal products, it may be relevant to consider therapeutic monitoring of the effect or concentration of these products and the individual dose of the medicinal product may need to be adjusted.
Croatian: Nakon početka ili završetka liječenja Kineretom u bolesnika koji primaju ove vrste lijekova preporučuje se provedba terapijskog praćenja učinka ili koncentracije tih lijekova te može biti potrebna prilagodba individualne doze lijeka.
English: Your doctor may decide that it would be more convenient for you to inject Kineret yourself.
Croatian: Liječnik može odlučiti da će biti primjerenije za Vas da sami sebi injicirate Kineret.
English: This section contains information on how to give yourself or your child an injection of Kineret.
Croatian: Ovaj dio sadrži informacije o tome kako ćete sami sebi ili svom djetetu injicirati Kineret.
English: This is called a subcutaneous injection.
Croatian: To se zove potkožna injekcija.
English: Injecting the solution with the air bubble is harmless.
Croatian: Injiciranje otopine s mjehurićem zraka nije štetno.
English: Alternating the injection site is recommended to avoid discomfort at the site of injection.
Croatian: Preporučuje se izmjena mjesta injiciranja kako bi se izbjegla nelagoda na mjestu primjene.
English: Any unused medicine must be discarded.
Croatian: Neiskorišteni lijek treba baciti.
English: * Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.
Croatian: * Antagonist receptora humanog interleukina-1 (r-metHuIL-1ra) proizveden na stanicama Escherichia coli tehnologijom rekombinantne DNK.
English: • If you had a dose lower than 100 mg you will have been told to eject liquid from the syringe onto a gauze or tissue.
Croatian: • Ako ste morali primijeniti dozu manju od 100 mg, dobili ste uputu da tekućinu istisnete iz štrcaljke na gazu ili maramicu.
English: During the 5-year study 14 patients (32.6%) reported 24 serious events.
Croatian: Tijekom 5-godišnjeg ispitivanja 14 je bolesnika (32,6%) prijavilo
English: The pre-filled syringe is for single use only.
Croatian: Napunjena štrcaljka namijenjena je isključivo za jednokratnu uporabu.