FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of patients randomised
Croatian: Broj randomiziranih bolesnika
English: Serious outcomes have included respiratory failure and prolonged hospitalisation.
Croatian: Ozbiljni ishodi su uključivali respiratorni zastoj i produljenu hospitalizaciju.
English: If you stop using Stelara It is not dangerous to stop using Stelara.
Croatian: Ako prestanete primjenjivati Stelaru Nije opasno prekinuti primjenu Stelare.
English: Antibodies to ustekinumab may develop during ustekinumab treatment and most are neutralising.
Croatian: Tijekom liječenja ustekinumabom mogu se razviti protutijela na ustekinumab, a većina ih je neutralizirajuća.
English: Improvement has been reported after discontinuation of ustekinumab and also, in some cases, administration of corticosteroids.
Croatian: Poboljšanje je prijavljeno nakon prekida primjene ustekinumaba i također, u nekim slučajevima, primjene kortikosteroida.
English: Stelara can cause serious side effects, including allergic reactions and infections.
Croatian: Stelara može uzrokovati ozbiljne nuspojave, uključujući alergijske reakcije i infekcije.
English: Immunomodulators and/or corticosteroids may be continued during treatment with STELARA.
Croatian: Imunomodulatori i/ili kortikosteroidi mogu se nastaviti uzimati tijekom liječenja STELAROM.
English: Etanercept 24 doses (50 mg twice a week)
Croatian: Etanercept 24 doze (50 mg dva puta tjedno)
English: If necessary, the diluted infusion solution may be stored at room temperature.
Croatian: Ukoliko je potrebno, razrijeđena infuzijska otopina se može čuvati na sobnoj temperaturi.
English: • it is the right medicine
Croatian: • da je to ispravan lijek
English: Date of first authorisation: 16 January 2009 Date of latest renewal: 19 September 2013
Croatian: Datum posljednje obnove odobrenja: 19. rujna 2013.
English: Specific studies have not been conducted in patients who had recently received live viral or live bacterial vaccines.
Croatian: Nisu provedena posebna ispitivanja kod bolesnika koji su nedavno primili živa virusna ili živa bakterijska cjepiva.
English: Stelara belongs to a group of medicines called ‘immunosuppressants'.
Croatian: Stelara pripada skupini lijekova koji se nazivaju 'imunosupresivi'.
English: Figure 1 shows what the pre-filled syringe looks like.
Croatian: Slika 1 prikazuje kako izgleda napunjena štrcaljka.
English: • Itching (‘pruritus')
Croatian: • svrbež (‘pruritus')
English: Look out for serious side effects
Croatian: Obratite pozornost na ozbiljne nuspojave
English: • The doctor will work out the right dose for you, including the amount (volume) of Stelara to be injected to give the right dose.
Croatian: • Liječnik će odrediti ispravnu dozu za Vas, uključujući količinu (volumen) Stelare koju je potrebno injicirati kako bi se primjenila ispravna doza.
English: The syringe is fitted with a passive safety guard.
Croatian: Štrcaljka je opremljena pasivnim sigurnosnim štitnikom.
English: Your doctor may decide that you should not use Stelara until the infection goes away.
Croatian: Vaš liječnik će možda odlučiti da ne smijete primjenjivati Stelaru dok se infekcija ne povuče.
English: Non-clinical data reveal no special hazard (e.g. organ toxicity) for humans based on studies of repeated-dose toxicity and developmental and reproductive toxicity, including safety pharmacology evaluations.
Croatian: Neklinički podaci pokazuju da nema posebnog rizika (npr. toksičnost za organe) za ljude na temelju ispitivanja toksičnosti ponovljenih doza te razvojne i reproduktivne toksičnosti, uključujući farmakološke procjene sigurnosti.
English: • If you have or have had a recent infection or if you have any abnormal skin openings (fistulae).
Croatian: • ako imate ili ste nedavno imali infekciju ili ako imate abnormalne otvore na koži (fistule)
English: • Slow down the damage to your joints.
Croatian: • usporavanja oštećenja Vaših zglobova.
English: • If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na ustekinumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Other medicines, vaccines and Stelara
Croatian: Drugi lijekovi, cjepiva i Stelara
English: Stelara is for single use only.
Croatian: Stelara je samo za jednokratnu upotrebu.
English: • fever, flu-like symptoms, night sweats
Croatian: • vrućicu, simptome nalik gripi, znojenje noću
English: The induction studies included 1409 (UNITI-1, n = 769; UNITI-2 n = 640) patients.
Croatian: Ispitivanja uvodnog liječenja uključila su 1409 (UNITI-1, n = 769; UNITI-2 n = 640) bolesnika.
English: These treatments may also weaken part of the immune system.
Croatian: Ovi načini liječenja također mogu oslabiti dio imunološkog sustava.
English: The final volume in the infusion bag should be 250 mL.
Croatian: Konačni volumen u infuzijskoj vrečići trebao bi biti 250 ml.
English: Let the pre-filled syringe stand outside the box for about half an hour.
Croatian: Ostavite napunjenu štrcaljku da odstoji izvan kutije oko pola sata.
English: Your doctor will examine you and do a test for tuberculosis, before you have Stelara.
Croatian: Liječnik će vas pregledati i provesti test na tuberkulozu, prije primjene Stelare.
English: A pre-specified integrated analysis combining data from 927 subjects in both PsA Study 1 and 2 was performed.
Croatian: Provedena je unaprijed integrirana analiza s kombiniranim podacima za 927 ispitanika iz oba PsA Ispitivanja 1 i 2.
English: Allergic reactions - these may need urgent treatment.
Croatian: Alergijske reakcije - njih možda treba hitno liječiti.
English: Respiratory
Croatian: Respiratorne
English: Patients receiving STELARA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
Croatian: Bolesnici koji primaju STELARU moraju se stalno nadzirati zbog znakova i simptoma aktivne tuberkuloze tijekom i nakon liječenja.
English: Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity.
Croatian: Jednokratne doze do 6 mg/kg primijenjene su intravenski u kliničkim ispitivanjima bez toksičnosti koja ograničava dozu.
English: • Stelara 130 mg concentrate for solution for infusion is given in a hospital or clinic and patients should not need to store or handle it.
Croatian: • Lijek Stelara 130 mg koncentrat za otopinu za infuziju primjenjuje se u bolnici ili na klinici i bolesnik ga neće morati čuvati ili rukovati s njime.
English: In patients who have responded to treatment with STELARA, corticosteroids may be reduced or discontinued in accordance with standard of care.
Croatian: U bolesnika koji su odgovorili na liječenje STELAROM, kortikosteroidi se mogu smanjiti ili obustaviti u skladu sa standardnom skrbi.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC05.
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC05.
English: • warm, red and painful skin, or a painful skin rash with blisters
Croatian: • toplu, crvenu i bolnu kožu ili bolni osip kože s mjehurima
English: If you have Crohn's disease you will first be given other medicines.
Croatian: Ako imate Crohnovu bolest, prvo će Vam biti primijenjeni drugi lijekovi.
English: Before you use Stelara tell your doctor:
Croatian: Prije primjene Stelare, recite liječniku:
English: • If you are having or have ever had injections to treat allergies - it is not known if Stelara may affect these.
Croatian: • ako primate ili ste ikada primili injekcije za liječenje alergija - nije poznato može li Stelara utjecati na njih
English: • Do not touch this area again before giving the injection.
Croatian: • Nemojte ponovno dodirivati to područje prije primjene injekcije.
English: The adverse reactions are classified by System Organ Class and frequency, 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 (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti, primjenom sljedećih kategorija: 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: • If possible, do not use areas of skin that show signs of psoriasis
Croatian: • Ako je moguće, nemojte injekciju primjeniti u područja kože koja pokazuju znakove psorijaze.
English: PASI 75 responders PASI 90 responders PASI 100 responders CDLQI
Croatian: PASI 75 odgovor PASI 90 odgovor PASI 100 odgovor CDLQI
English: CDLQI of 0 or 1 indicates no effect on child's quality of life.
Croatian: CDLQI 0 ili 1 znači da nema utjecaja na kvalitetu života djeteta.
English: These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications.
Croatian: To mogu biti znakovi infekcija, poput infekcija u prsnom košu ili kožnih infekcija ili herpes zostera, koje mogu imati ozbiljne komplikacije.
English: • If you have or have had a recent infection.
Croatian: • ako imate ili ste nedavno imali infekciju
English: Only use complete vials of STELARA.
Croatian: Koristite samo cijele bočice STELARE.
English: Week 12 2 doses (week 0 and week 4)
Croatian: Tjedan 12 2 doze (Tjedan 0 i Tjedan 4)
English: Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever.
Croatian: Odmah obavijestite svog liječnika ako Vam se pojave simptomi kao što su kašalj, nedostatak zraka i vrućica.
English: Patients enrolled PGA
Croatian: Uključeni bolesnici PGA
English: In the population pharmacokinetic analysis, there were no indications of an effect of tobacco or alcohol on the pharmacokinetics of ustekinumab.
Croatian: U farmakokinetičkoj analizi populacije, nije bilo indikacija o učinku duhana ili alkohola na farmakokinetiku ustekinumaba.
English: Prolonged vigorous shaking may damage the medicine.
Croatian: Dugotrajno snažno protresanje može oštetiti lijek.
English: • Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger.
Croatian: • Držite napunjenu štrcaljku jednom rukom koristeći srednji prst i kažiprst, te stavite palac na vrh glave klipa, a drugom rukom nježno uhvatite nabor očišćene kože između palca i kažiprsta.
English: Use a new needle and syringe for each injection.
Croatian: Za svaku injekciju koristite novu iglu i štrcaljku.
English: There were no indications of an interaction with these concomitantly administered medicinal products.
Croatian: Nije bilo indicija interakcije s istovremeno primijenjenim lijekovima.
English: Clinical response and remission were significant as early as week 3 in ustekinumab treated patients and continued to improve through week 8.
Croatian: Klinički odgovor i remisija bili su značajni već u 3. tjednu u bolesnika liječenih ustekinumabom i nastavili su se poboljšavati do 8. tjedna.
English: The solution may contain a few small translucent or white particles of protein.
Croatian: Otopina može sadržavati male prozirne ili bijele čestice proteina.
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Croatian: Bolesnike se mora uputiti da zatraže liječnički savjet ako se pojave znakovi ili simptomi koji upućuju na infekciju.
English: Instructions for dilution:
Croatian: Upute za razrjeđivanje:
English: It is not known whether STELARA may affect allergy immunotherapy.
Croatian: Nije poznato može li STELARA utjecati na imunoterapiju alergija.
English: See ‘Serious side effects' in section 4 for a full list of these side effects.
Croatian: Pogledajte dio 'Ozbiljne nuspojave' u dijelu 4 za cjeloviti popis ovih nuspojava.
English: You and your doctor should decide if you should breast-feed or use Stelara - do not do both.
Croatian: Vi i Vaš liječnik trebate odlučiti trebate li dojiti ili uzimati Stelaru - nemojte oboje.
English: • If you have ever had an allergic reaction to latex or Stelara injection - the container of this medicinal product contains latex rubber, which may cause severe allergic reactions in people who are sensitive to latex.
Croatian: • ako ste ikada imali alergijsku reakciju na lateks ili na injekciju Stelare - spremnik ovog lijeka sadrži lateks gumu koja može izazvati teške alergijske reakcije kod ljudi koji su osjetljivi na lateks.
English: • feeling tired or short of breath; cough which will not go away
Croatian: • osjećaj umora ili nedostatak zraka; kašalj koji ne prolazi
English: If you have active psoriatic arthritis you will first be given other medicines.
Croatian: Imate li aktivni psorijatični artritis, najprije ćete dobiti druge lijekove.
English: PGA = Physician Global Assessment
Croatian: Physician Global Assessment) Globalna procjena liječnika.
English: Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails.
Croatian: Plak psorijaza je stanje kože koje uzrokuje upalu koja utječe na kožu i nokte.
English: If you do not respond well enough to these medicines, you may be given Stelara to:
Croatian: Ako ne odgovorite dovoljno dobro na te lijekove, možete dobiti Stelaru radi:
English: • The recommended starting dose is 45 mg Stelara.
Croatian: • Preporučena početna doza je 45 mg Stelare.
English: • Peeling of the skin (skin exfoliation)
Croatian: • ljuštenje kože (eksfolijacija kože)
English: Clinically important, active infection (e.g. active tuberculosis; see section 4.4).
Croatian: Klinički značajna, aktivna infekcija (npr. aktivna tuberkuloza; vidjeti dio 4.4).
English: There is no apparent correlation between the presence of anti-ustekinumab antibodies and the occurrence of injection site reactions.
Croatian: Ne postoji očita korelacija između prisutnosti protutijela na ustekinumab i pojave reakcija na mjestu primjene injekcije.
English: What Stelara is and what it is used for
Croatian: Što je Stelara i za što se koristi
English: PsARC responses were maintained through weeks 52 and 100.
Croatian: PsARC odgovori zadržali su se kroz 52 i 100 tjedana.
English: The primary endpoint was the percentage of patients who achieved American College of Rheumatology (ACR) 20 response at week 24.
Croatian: Primarni ishod bio je postotak bolesnika koji su u 24. tjednu dostigli odgovor 20 prema American College of Rheumatology (ACR).
English: • Hold the syringe with the needle pointing up to see if it has any air bubbles inside
Croatian: • Držite štrcaljku s iglom prema gore kako biste vidjeli ima li unutra mjehurića zraka.
English: Check the number of pre-filled syringes and prepare the materials:
Croatian: Provjerite količinu napunjenih štrcaljki i pripremite pribor:
English: Steady state ustekinumab concentration was achieved by the start of the second maintenance dose.
Croatian: Koncentracija ustekinumaba u stanju dinamičke ravnoteže bila je postignuta do početka druge doze održavanja.
English: Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment.
Croatian: Nakon stavljanja lijeka u promet prijavljene su ozbiljne reakcije preosjetljivosti, u nekim slučajevima nekoliko dana nakon liječenja.
English: Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.
Croatian: Žene reproduktivne dobi trebaju koristiti učinkovite metode kontracepcije tijekom liječenja i do 15 tjedana nakon liječenja.
English: • After the expiry date which is stated on the label and the carton after ‘EXP'.
Croatian: • Nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake “EXP”.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću, razvoj embrija/fetusa, porod ili postnatalni razvoj (vidjeti dio 5.3).
English: Efficacy results presented for UNIFI-I and UNIFI-M were based on central review of endoscopies.
Croatian: Prikazani rezultati za djelotvornost iz ispitivanja UNIFI-I i UNIFI-M temeljili su se na središnjoj ocjeni endoskopskih nalaza.
English: • For instructions on how to inject Stelara, see ‘Instructions for administration' at the end of this leaflet.
Croatian: • Za upute o tome kako ćete primijeniti Stelaru injekcijom pogledajte dio 'Upute za primjenu' na kraju ove upute o lijeku.
English: The recommended dose of STELARA based on body weight is shown below (Tables 1 and 2).
Croatian: Preporučena doza STELARE temeljena na tjelesnoj težini prikazana je ispod (Tablica 1 i 2).
English: Choose and prepare the injection site:
Croatian: Odaberite i pripremite mjesta za primjenu injekcije:
English: The majority of patients who lost response and resumed ustekinumab did so within 24 weeks of the induction infusion.
Croatian: Većina bolesnika koji su izgubili odgovor i koji su ponovno nastavili s ustekinumabom, napravili su to unutar 24 tjedna od uvođenja infuzije.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Croatian: U slučaju predoziranja, preporučuje se nadzirati bolesnika radi praćenja bilo kakvih znakova ili simptoma nuspojava te odmah treba započeti s odgovarajućim simptomatskim liječenjem.
English: • Do not rub the skin at the injection site.
Croatian: • Nemojte trljati kožu na mjestu primjene injekcije.
English: Serious skin conditions
Croatian: Ozbiljna stanja kože
English: • If you are having any other treatment for psoriasis and/or psoriatic arthritis - such as another immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet (UV) light).
Croatian: • ako psorijazu i/ili psorijatični artritis liječite na bilo koji drugi način - na primjer drugim imunosupresivom ili fototerapijom (kada se Vaše tijelo liječi vrstom ultraljubičastih (UV) zraka).
English: If you forget to use Stelara
Croatian: Ako ste zaboravili primijeniti Stelaru
English: • After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.
Croatian: • Nakon početne doze, dobit ćete sljedeću dozu 4 tjedna kasnije, a zatim svakih 12 tjedana.
English: The effect is considered demonstrated irrespective of concomitant MTX use, and was maintained through Weeks 52 (integrated analysis) and 100 (PsA Study 1).
Croatian: 1. Smatra se da se učinak pokazao bez obzira na istovremeno uzimanje MTX, te se održao kroz 52 tjedna (integrirana analiza) i 100 tjedana (PsA Ispitivanje 1).
English: It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA.
Croatian: Preporuka je da se živa virusna ili živa bakterijska cjepiva (kao što je cjepivo Bacillus CalmetteGuérin (BCG)) ne smiju davati istovremeno sa STELAROM.
English: In these studies, 2.2% of 785 placebo treated patients and 1.9% of 790 patients treated with the recommended dose of ustekinumab reported adverse events occurring during or within an hour of the infusion.
Croatian: U tim ispitivanjima, 2,2% od 785 bolesnika koji su primali placebo i 1,9% od 790 bolesnika liječenih preporučenom dozom ustekinumaba prijavilo je štetne događaje koji su se pojavili tijekom ili unutar jednog sata od infuzije.
English: In PsA Study 1 (PSUMMIT I) and PsA Study 2 (PSUMMIT II), 80% and 86% of the patients, respectively, had been previously treated with DMARDs.
Croatian: U ispitivanju PsA 1 (PSUMMIT I) i PsA 2 (PSUMMIT II), 80% odnosno 86% bolesnika, prethodno je bilo liječeno DMARD-ovima.
English: Infections - these may need urgent treatment.
Croatian: Infekcije - njih možda treba hitno liječiti.
English: • Do not mix Stelara with other liquids for injection
Croatian: • Nemojte miješati Stelaru s drugim tekućinama za injekciju.
English: Johnson & Johnson d.o.o.
Croatian: Johnson & Johnson d.o.o. Tel.
English: • Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button)
Croatian: • Dobra mjesta za davanje injekcije su gornji dio bedara ili na trbuhu (abdomen), najmanje 5 cm od pupka.
English: The ratio of patients with basal versus squamous cell skin cancers (3:1) is comparable with the ratio expected in the general population (see section 4.4).
Croatian: Omjer bolesnika sa bazocelularnim u odnosu na planocelularni karcinom kože (3:1) može se usporediti s omjerom očekivanim u općoj populaciji (vidjeti dio 4.4).
English: In Crohn's disease, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.
Croatian: Ukoliko se kod Crohnove bolesti liječenje privremeno prekine, nastavak liječenja uz supkutano doziranje svakih 8 tjedana je sigurno i učinkovito.
English: Systemic
Croatian: Sistemske
English: The effects of Stelara in pregnant women are not known.
Croatian: Učinci Stelare kod trudnica nisu poznati.
English: Similarly, significant improvements were seen in Psoriasis Study 2 at week 4 and 12, which were sustained through week 24.
Croatian: Jednako tako, došlo je do značajnog poboljšanja u Ispitivanju psorijaze 2 u tjednu 4 i 12, a zadržalo se tijekom tjedna 24.
English: STELARA must not be given to patients with active tuberculosis (see section 4.3).
Croatian: STELARA se ne smije davati bolesnicima s aktivnom tuberkulozom (vidjeti dio 4.3).
English: Similar results were obtained from a confirmatory population pharmacokinetic analysis using data from patients with psoriatic arthritis.
Croatian: Slični rezultati dobiveni su konfirmatornom farmakokinetičkom analizom populacije, koristeći podatke bolesnika s psorijatičnim artritisom.
English: See ‘Look out for serious side effects' in section 4 for the signs of an allergic reaction.
Croatian: Pogledajte dio 'Obratite pozornost na ozbiljne nuspojave' u dijelu 4 za prepoznavanje znakova alergijske reakcije.
English: Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag.
Croatian: Izvucite 26 ml STELARE iz svake bočice koja Vam je potrebna i dodajte ga u infuzijsku vrećicu od 250 ml.
English: • You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle.
Croatian: • Možda ćete primijetiti mjehuriće zraka u napunjenoj štrcaljki ili kapljicu tekućine na vrhu igle.
English: Clinical Remission*
Croatian: Klinička remisija*
English: Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy.
Croatian: Imunosupresivi poput ustekinumaba mogu povećati rizik od zloćudnih bolesti.
English: Prepare the injection site
Croatian: Pripremite mjesta primjene injekcije
English: Similar disease severity was also seen in Psoriasis Study 3.
Croatian: Slična težina bolesti primjećena je također i u Ispitivanju psorijaze 3.
English: There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks.
Croatian: Nije bilo očite akumulacije u serumskoj koncentraciji ustekinumaba tijekom vremena kada se davao supkutano svakih 12 tjedana.
English: • Do not touch the needle guard activation clips (as indicated by asterisks * in Figure 1) to prevent prematurely covering the needle with the needle guard.
Croatian: • Nemojte dirati aktivacijske kvačice štitnika igle (označene zvjezdicama * na Slici 1) kako biste spriječili prijevremeno pokrivanje igle štitnikom igle
English: No specific studies have been conducted with intravenous ustekinumab in elderly or paediatric patients.
Croatian: Nisu provedena posebna ispitivanja s intravenskim ustekinumabom na starijim ili pedijatrijskim bolesnicima.
English: If you don't know the amount or type of syringe needed, contact your healthcare provider for further instruction.
Croatian: Ukoliko ne znate potrebnu količinu ili tip štrcaljke, obratite se zdravstvenom radniku za daljnje upute.