FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients randomised to ustekinumab received 45 mg for patients ≤100 kg and 90 mg for patients >100 kg at Weeks 0, 4, and 16 followed by same dose every 12 weeks.
Croatian: Bolesnici randomizirani za liječenje ustekinumabom primali su 45 mg za bolesnike ≤100 kg i 90 mg za bolesnike >100 kg u 0., 4. i 16. tjednu, nakon čega je slijedila ista doza svakih 12 tjedana.
English: Arthralgia Myalgia
Croatian: Često artralgija mialgija
English: • If your doctor decides that you or a caregiver can give the injections at home, you or your caregiver should receive training on the right way to prepare and inject Kyntheum.
Croatian: • Ako liječnik odluči da Vi ili Vaš njegovatelj možete davati injekcije kod kuće, Vi ili Vaš njegovatelj morat ćete proći obuku o ispravnom načinu pripreme i injiciranja lijeka Kyntheum.
English: In moderate to severe plaque psoriasis patients following a single subcutaneous administration of Kyntheum at 210 mg, the mean maximum serum concentration (Cmax) was 13.4 mcg/ml (standard deviation [SD] = 7.29 mcg/ml).
Croatian: U bolesnika s umjerenom do teškom plak psorijazom nakon jedne supkutane primjene lijeka Kyntheum od 210 mg, srednja maksimalna koncentracija u serumu (Cmax) bila je 13,4 mcg/ml (standardno odstupanje [engl. standard deviation, SD] = 7,29 mcg/ml).
English: The safety and efficacy of Kyntheum in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Croatian: Nije procijenjena sigurnost i učinkovitost lijeka Kyntheum u kombinaciji s imunosupresivima,
English: The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
Croatian: Preporučena doza je 210 mg primijenjena supkutanom injekcijom u 0., 1. i 2. tjednu, a zatim 210 mg svaka 2 tjedna.
English: • cotton ball or gauze pad
Croatian: • pamučnu vaticu ili tupfer od gaze
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA
English: Patients originally randomised to placebo received Kyntheum 210 mg every 2 weeks beginning at Week 12.
Croatian: Bolesnici koji su izvorno bili randomizirani za primanje placeba primali su Kyntheum 210 mg svaka 2 tjedna, počevši od 12. tjedna.
English: Then, gently remove the syringe from your skin
Croatian: Potom pažljivo odvojite štrcaljku od kože
English: • muscle pain.
Croatian: • bol u mišićima.
English: Grab the syringe barrel to remove the syringe from the tray.
Croatian: Primite tijelo štrcaljke da biste štrcaljku odvojili od podloška.
English: All three trials included a 12-week placebo-controlled induction phase, a double-blind duration of 52 weeks, and an open-label long-term extension.
Croatian: Sva tri ispitivanja uključivala su 12-tjednu placebom kontroliranu fazu indukcije, dvostruko slijepo ispitivanje u trajanju od 52 tjedna i dugoročni nastavak ispitivanja kao otvorenog ispitivanja.
English: Medicine
Croatian: Lijek
English: Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution (140 mg/1 ml).
Croatian: Jedna napunjena štrcaljka sadrži 210 mg brodalumaba u otopini od 1,5 ml (140 mg/1 ml).
English: • Kyntheum is injected in your upper legs (thighs) or stomach area (abdomen) by you or a caregiver.
Croatian: • Kyntheum sami injicirate u natkoljenicu (bedro) ili trbuh, ili Vam ga injicira njegovatelj.
English: Kyntheum is a sterile solution for injection in pre-filled syringe.
Croatian: Kyntheum je sterilna otopina za injekciju u napunjenoj štrcaljki.
English: Renal and hepatic impairment Kyntheum has not been studied in these patient populations.
Croatian: Kyntheum nije ispitivan u tim populacijama bolesnika.
English: How to store Kyntheum
Croatian: Kako primjenjivati Kyntheum
English: • Do not use the syringe if:
Croatian: • Nemojte upotrebljavati štrcaljku u sljedećim slučajevima:
English: During the 12-week placebo-controlled clinical trial period in patients with psoriasis, serious infections were observed in 0.5% of patients receiving Kyntheum (see section 4.8).
Croatian: Tijekom 12-tjednog placebom kontroliranog kliničkog istraživanja u bolesnika s psorijazom opažene su ozbiljne infekcije u 0,5% bolesnika koji primaju Kyntheum (vidjeti dio 4.8).
English: Throw the needle cap into the sharps disposal container provided.
Croatian: Bacite zatvarač igle u pripremljeni spremnik za oštre predmete.
English: None of the Grade 3 or 4 ANC decreases in the psoriasis patients were associated with a serious infection (see also section
Croatian: Nijedno od smanjenja ANC-a stupnja 3 i 4 u bolesnika s psorijazom nije bilo povezano s ozbiljnom infekcijom (vidjeti i dio 4.8).
English: Injection site reactions (including injection site erythema, pain, pruritus, bruising, haemorrhage)
Croatian: Često umor reakcije na mjestu injiciranja (uključujući eritem, bol, pruritus, stvaranje modrica, krvarenje na mjestu injiciranja)
English: Solution for injection 2 pre-filled syringes.
Croatian: Otopina za injekciju 2 napunjene štrcaljke.
English: • Put your used pre-filled syringe in a puncture resistant sharps disposal container straight after use.
Croatian: • Upotrijebljenu napunjenu štrcaljku odmah nakon uporabe stavite u spremnik za odlaganje oštrih predmeta.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: • Do not use after the expiry date on the label.
Croatian: • Nemojte upotrebljavati lijek nakon roka valjanosti na naljepnici.
English: Exercise caution when prescribing Kyntheum to patients with a history of Crohn's disease.
Croatian: Potreban je oprez pri propisivanju lijeka Kyntheum bolesnicima s poviješću Crohnove bolesti.
English: Neutropenia Grade 3 and 4 were reported in 0.4% of patients receiving Kyntheum compared to 0.2% of patients who received ustekinumab and none in patients receiving placebo.
Croatian: Neutropenija stupnja 3 i 4 prijavljena je u 0,4% bolesnika koji su primali Kyntheum u usporedbi s 0,2% bolesnika koji su primali ustekinumab i nijednim bolesnikom koji je primao placebo.
English: Store in the outer package in order to protect from light.
Croatian: Čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Infekcije
English: Anti-tuberculosis therapy should be considered prior to initiation of Kyntheum in patients with latent tuberculosis.
Croatian: U bolesnika s latentnom tuberkulozom treba razmotriti primjenu terapije za tuberkulozu prije početka liječenja lijekom Kyntheum.
English: Serious infections occurred in 0.5% of patients treated with Kyntheum and in 0.2% of patients treated with placebo.
Croatian: Ozbiljne infekcije pojavile su se u 0,5% bolesnika koji su primali Kyntheum i 0,2% bolesnika koji su primali placebo.
English: In cynomolgus monkeys there were no effects on male and female reproductive organs and on sperm count, motility and morphology following administration of brodalumab at dose levels up to 90 mg/kg once weekly for 6 months, (AUC exposure up to 47-fold higher than in human patients receiving Kyntheum 210 mg every 2 weeks).
Croatian: U makaki majmuna nije bilo učinka na muške ili ženske reproduktivne organe i broj spermija, njihovu pokretljivost i morfologiju nakon primjene brodalumaba u dozama do 90 mg/kg jedanput tjedno tijekom 6 mjeseci (AUC izloženost do 47 puta veća nego u ljudskih bolesnika koji primaju Kyntheum od 210 mg svaka dva tjedna).
English: • If needed, you may store the Kyntheum pre-filled syringe at room temperature up to 25°C for up to 14 days.
Croatian: • Po potrebi se napunjena štrcaljka lijeka Kyntheum može čuvati na sobnoj temperaturi do 25°C
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NAPUNJENE ŠTRCALJKE
English: • Keep out of the sight and the reach of children.
Croatian: • Čuvati izvan pogleda i dohvata djece.
English: You or your caregiver can use:
Croatian: Vi ili Vaš njegovatelj možete injicirati lijek u:
English: How much Kyntheum is given
Croatian: Koliko se lijeka Kyntheum daje
English: G. Hold the pinched skin.
Croatian: Držite kožu stisnutu.
English: Important: Always hold the pre-filled syringe by the syringe barrel.
Croatian: Važno: Napunjenu štrcaljku uvijek držite samo za tijelo štrcaljke.
English: Elderly (aged 65 years and over) No dose adjustment is recommended in elderly patients (see section 5.2).
Croatian: Ne preporučuje se prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
English: The efficacy and safety of Kyntheum was assessed in 4373 adult plaque psoriasis patients across three multinational, randomised, double-blind, phase 3, placebo-controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3).
Croatian: Djelotvornost i sigurnost lijeka Kyntheum ocjenjivala se u 4373 odrasla bolesnika s plak psorijazom u tri višenacionalna, randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja faze
English: pharmacist or nurse if you or your caregiver have any questions about the right way to inject Kyntheum.
Croatian: Nazovite liječnika, ljekarnika ili medicinsku sestru u slučaju da Vi ili Vaš njegovatelj imate bilo kakvih pitanja u vezi s ispravnim injiciranjem lijeka Kyntheum.
English: In cynomolgus monkeys, no effects on embryo-foetal or postnatal (up to 6 months of age) development were observed when brodalumab was dosed subcutaneously throughout pregnancy at exposure levels up to 27-fold higher than those achieved in human patients receiving Kyntheum 210 mg every 2 weeks based on the area under the concentration curve (AUC).
Croatian: U makaki majmuna nisu opaženi učinci na embrijsko-fetalni ili postnatalni (do dobi od 6 mjeseci) razvoj pri supkutanom doziranju brodalumaba u cijeloj trudnoći uz razine izloženosti do 27 puta veće od onih u ljudskih bolesnika koji primaju Kyntheum od 210 mg svaka dva tjedna na temelju površine ispod krivulje (AUC).
English: Following a single subcutaneous administration of brodalumab 210 mg in plaque psoriasis patients, the apparent clearance (CL/F) is 2.95 L/day.
Croatian: Nakon pojedinačne potkožne primjene 210 mg brodalumaba u bolesnika s plak psorijazom prividni klirens (CL/F) iznosi 2,95 l/dan.
English: Each pre-filled syringe is for single use only.
Croatian: Jedna napunjena štrcaljka namijenjena je samo za jednokratnu uporabu.
English: A caregiver may also give you an injection in your upper, outer arm.
Croatian: Njegovatelj vam može dati injekciju i u stražnji dio nadlaktice.
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu zahvatiti do 1 osobe na 100 ljudi):
English: Tell your doctor if you are breast-feeding or plan to breast-feed.
Croatian: Obavijestite liječnika ako dojite ili planirate dojiti.
English: Population pharmacokinetic modelling indicated that age did not have an effect on brodalumab pharmacokinetics, which was co-based on 259 (6%) patients being 65-74 years old and on 14 (0.3%)
Croatian: Populacijsko farmakokinetičko modeliranje pokazalo je da dob nije utjecala na farmakokinetiku brodalumaba, što se temeljilo na 259 (6%) bolesnika u dobi od 65 do 74 godine i na 14 (0,3%) bolesnika u dobi od 75 godina i više, unutar ukupne PK populacije od 4271 bolesnika s plak psorijazom.
English: Kyntheum is a solution for injection that is a clear to slightly pearly, colourless to slightly yellow liquid, with no particles.
Croatian: Kyntheum je otopina za injekciju koja je bistra do blago biserna, bezbojna do žućkasta tekućina bez čestica.
English: Both trials included a 12-week double-blind, placebo- and ustekinumab-controlled induction phase followed by a double-blind maintenance phase up to 52 weeks.
Croatian: Oba su ispitivanja uključivala 12-tjednu, dvostruko slijepu, placebom, odnosno ustekinumabom kontroliranu fazu indukcije nakon koje je slijedila dvostruko slijepa faza održavanja do 52 tjedna.
English: Rescue treatment was available at or after Week 16 for patients with an inadequate response single sPGA ≥3 or persistent sPGA of 2 over at least a 4-week period.
Croatian: ≥3 ili trajnim odgovorom sPGA od 2 tijekom razdoblja od najmanje četiri tjedna.
English: Patients were predominantly men (69%) and white (91%), with a mean age of 45 years (18 to 86 years), of these 6.1% were >65 years of age and 0.3% were >75 years of age.
Croatian: (18 do 86 godina), od čega ih je 6,1% bilo starije od 65 godina, a 0,3% starije od 75 godina.
English: • the medicine is cloudy or discoloured or contains flakes or particles
Croatian: • lijek je zamućen, promijenio je boju ili sadrži komadiće ili čestice
English: Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
Croatian: Jedna napunjena štrcaljka sadrži 210 mg brodalumaba u otopini od 1,5 ml.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Kyntheum Lijek čuvajte izvan pogleda i dohvata djece.
English: • Do not inject into an area of the skin that is tender, bruised, red, hard or in an area of skin that is affected by psoriasis.
Croatian: • Nemojte injicirati lijek u područje kože koje je osjetljivo na dodir, prekriveno modricama, crveno, tvrdo, debelo ili u područje kože zahvaćeno psorijazom.
English: During the 12-week placebo-controlled period of clinical trials, neutropenia was reported in 0.8% of patients treated with Kyntheum compared with 0.5% of patients treated with placebo.
Croatian: Tijekom 12-tjednog razdoblja placebom kontroliranih kliničkih ispitivanja prijavljena je neutropenija u 0,8% bolesnika koji su primali Kyntheum u usporedbi s 0,5% bolesnika koji su primali placebo.
English: The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation.
Croatian: Povišene razine određenih citokina (npr. IL-1, IL-6, IL-10, TNFα, IFN) tijekom kronične upale mogu promijeniti stvaranje enzima CYP450.
English: Live vaccines should not be given concurrently with Kyntheum (see section 4.5).
Croatian: Živa se cjepiva ne smiju davati istodobno s lijekom Kyntheum (vidjeti dio 4.5).
English: Live vaccines should not be given concurrently with Kyntheum (see section 4.4).
Croatian: Živa se cjepiva ne smiju davati istodobno s lijekom Kyntheum (vidjeti dio 4.4).
English: The most commonly reported adverse reactions in all Kyntheum-treated patients were arthralgia (4.6%), headache (4.3%), fatigue (2.6%), diarrhoea (2.2%), and oropharyngeal pain (2.1%).
Croatian: glavobolja (4,3%), umor (2,6%), proljev (2,2%) i orofaringealna bol (2,1%).
English: • Avoid injecting into areas with scars or stretch marks.
Croatian: • Nemojte injicirati lijek u područja prekrivena ožiljcima ili strijama.
English: Elevated levels of expression of IL-12B and IL-23A, the genes for the two subunits of IL-23, an upstream activator of IL-17A and IL-17F expression, are also found in psoriatic plaques.
Croatian: U psorijatičnim plakovima pronađene su i povišene razine ekspresije za IL-12B i IL-23A, gena za dvije podjedinice IL-23, uzvodnog aktivatora ekspresije za IL-17A i IL-17F.
English: Based on population pharmacokinetic modelling the estimated half-life of brodalumab was 10.9 days at steady-state after every other week subcutaneous dose of 210 mg.
Croatian: Poluvrijeme brodalumaba procijenjeno na temelju populacijskog farmakokinetičkog modeliranja iznosilo je 10,9 dana u stanju dinamičke ravnoteže nakon supkutane doze od 210 mg svakog drugog tjedna.
English: Kyntheum 210 mg injection brodalumab
Croatian: Kyntheum 210 mg injekcija brodalumab s.c.
English: • feeling sick
Croatian: • osjećaj mučnine
English: It is recommended that patients be brought up-to-date with all immunisations in accordance with local immunisation guidelines prior to initiation of treatment with Kyntheum.
Croatian: Prije početka liječenja lijekom Kyntheum preporučuje se izvršiti sva potrebna cijepljenja u skladu s lokalnim smjernicama za imunizaciju.
English: PASI 75 response at 2 weeks ranged between 20% and 25% in the Phase 3 trials compared to placebo (0% to 0.6%) and ustekinumab (3% to 3.5%).
Croatian: *p-vrijednost u odnosu na odgovarajući placebo, prilagođena za faktore stratifikacije <0,001 Odgovor PASI 75 nakon dva tjedna bio je u rasponu od 20% do 25% u ispitivanjima 3. faze u usporedbi s placebom (0% do 0,6%) i ustekinumabom (3% do 3,5%).
English: Tel: +420 225 992 272
Croatian: Pharma s.r.o. Tel: +420 225 992 272
English: Throw away Kyntheum that has been stored at room temperature for longer than 14
Croatian: Bacite Kyntheum ako je bio na sobnoj temperaturi dulje od 14 dana.
English: Solution for injection 2 pre-filled syringes
Croatian: Otopina za injekciju 2 napunjene štrcaljke
English: This medicine should not be used if the solution is cloudy or discoloured or contains lumps, flakes, or particles.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je otopina zamućena, ako je promijenila boju ili sadrži grudice, komadiće ili čestice.
English: Kyntheum can be kept at room temperature up to 25°C in the outer carton for 14 days.
Croatian: Kyntheum se može čuvati 14 dana u vanjskom pakiranju na sobnoj temperaturi do 25°C.
English: The trial included a 12-week double-blind, placebocontrolled induction phase followed by a double-blind withdrawal and retreatment phase up to 52 weeks.
Croatian: placebom kontroliranu fazu indukcije, nakon koje je slijedila dvostruko slijepa faza ukidanja liječenja i ponovnog liječenja do 52 tjedna.
English: • Do not shake the syringe.
Croatian: • Nemojte tresti štrcaljku.
English: Patients randomised to Kyntheum received 210 mg or 140 mg at Week 0 (day 1), Week 1, and Week 2 followed by same dose every 2 weeks.
Croatian: Bolesnici randomizirani za liječenje lijekom Kyntheum primali su 210 mg ili 140 mg u 0. tjednu (1. dan), 1. tjednu i 2. tjednu, nakon čega je slijedila ista doza svaka 2 tjedna.
English: Patients originally randomised to placebo and those who did not meet the criteria for re-randomisation received Kyntheum 210 mg every two weeks beginning at Week 12.
Croatian: Bolesnici koji su izvorno randomizirani za primanje placeba ili oni koji nisu ispunili kriterije za ponovnu randomizaciju primali su 210 mg lijeka
English: Oropharyngeal pain
Croatian: Tijelo štrcaljke
English: After use
Croatian: Nakon primjene
English: NA
Croatian: SAD
English: B. Check the Kyntheum pre-filled syringe
Croatian: Provjerite napunjenu štrcaljku lijeka Kyntheum
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: Tel: +421 2 5939 6236
Croatian: Pharma s.r.o. Tel: +421 2 5939 6236
English: How is Kyntheum given
Croatian: Kako se Kyntheum daje
English: N = number of patients, which are presented at baseline, Week 12, and Week 52 Q2W = every 2 weeks *Patients were administered ustekinumab in the induction phase and continued on ustekinumab in the maintenance phase **Patients were administered Kyntheum 210 mg every 2 weeks in the induction phase and re-randomised to Kyntheum 210 mg every 2 weeks in the maintenance phase NRI= Non-responder imputation
Croatian: **Bolesnici su primali Kyntheum 210 mg svaka dva tjedna u indukcijskoj fazi i bili su ponovno randomizirani za liječenje lijekom Kyntheum od 210 mg svaka dva tjedna u fazi održavanja NRI (Non-responder imputation) = dodavanje bolesnika bez odgovora
English: • Do not shake.
Croatian: • Nemojte tresti.
English: Always hold the syringe by the syringe barrel.
Croatian: Štrcaljku uvijek držite samo za tijelo štrcaljke.
English: Across treatment groups, the baseline Psoriasis Area Severity Index (PASI) score ranged from 9.4 to 72 (median: 17.4)
Croatian: Psoriasis Area Severity Index, PASI) od 9,4 do 72 (medijan: 17,4), a početna vrijednost zahvaćene površine kože (engl. body surface area, BSA) bila je u rasponu od 10 do 97 (medijan: 21).
English: If any of these side effects becomes severe, tell your doctor, nurse, or pharmacist.
Croatian: Ako bilo koja od nuspojava postane teška, obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
English: Along with primary efficacy endpoints, clinically important improvements were observed in Psoriasis Scalp Severity Index (PSSI) at Week 12 (AMAGINE-1) and in Nail Psoriasis Severity Index (NAPSI) at Week 12 and 52 (AMAGINE-1,-2, and -3).
Croatian: Nail Psoriasis Severity Index, NAPSI) u 12. i 52. tjednu (AMAGINE-1, -2 i -3).
English: What you need to know before you use Kyntheum Do not use Kyntheum:
Croatian: Što morate znati prije nego počnete primjenjivati Kyntheum
English: • Do not grasp the grey needle cap.
Croatian: • Nemojte primati sivi zatvarač igle.
English: • fever, flu-like symptoms, night sweats • feeling tired or short of breath, cough which will not go away
Croatian: • vrućicu, simptome nalik gripi, noćno znojenje
English: Tel: +386 4 2366 700
Croatian: PHARMAGAN d.o.o. Tel: +386 4 2366 700
English: • Do not hold the plunger.
Croatian: • Nemojte primati klip.
English: Kyntheum is available as a single-use pre-filled syringe.
Croatian: Kyntheum je dostupan u obliku napunjene štrcaljke za jednokratnu uporabu.
English: Comprehensive instructions for administration are given in the package leaflet.
Croatian: Opsežne upute za primjenu navedene su u uputi o lijeku.
English: Only your caregiver can use:
Croatian: Samo njegovatelj smije injicirati lijek u:
English: Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab
Croatian: Kyntheum 210 mg otopina za injekciju u napunjenoj štrcaljki brodalumab
English: Label and expiration date
Croatian: Naljepnica i rok valjanosti
English: Vaccination of infants
Croatian: Imunizacija dojenčadi
English: SC
Croatian: PC:
English: You may be treated with another medicine for TB before you begin treatment with Kyntheum
Croatian: Prije početka liječenja lijekom Kyntheum možda ćete se morati liječiti drugim lijekom
English: • Avoid injecting directly into raised, thick, red or scaly skin patches or lesions.
Croatian: • Nemojte injicirati lijek u izravno izdignuta, debela, crvena ili ljuskasta mjesta na koži ili lezije.
English: Carcinogenicity studies with brodalumab have not been conducted.
Croatian: Nisu provedena ispitivanja za ocjenjivanje kancerogenog potencijala.
English: During the 12-week placebo-controlled clinical trial period in patients with psoriasis, a decrease in absolute neutrophil count (ANC) was observed in 5.6% of patients receiving Kyntheum, which was generally transient and reversible.
Croatian: 5,6% bolesnika koji su primali Kyntheum opaženo je općenito prolazno i reverzibilno smanjenje apsolutnog broja neutrofila (ANC).
English: Proline
Croatian: OBLIK
English: Higher rates of fungal infections, primarily non-serious skin and mucosal candida infections, were observed in Kyntheum patients compared to placebo patients, 1.8% vs 0.9%, respectively.
Croatian: opaženi su u bolesnika koji su primali Kyntheum u usporedbi s bolesnicima koji su primali placebo, 1,8% u odnosu na 0,9%.
English: Kyntheum 210 mg solution for injection in pre-filled syringe
Croatian: Kyntheum 210 mg otopina za injekciju u napunjenoj štrcaljki.
English: Kyntheum is a clear to slightly opalescent, colourless to slightly yellow solution, free from particles.
Croatian: Kyntheum je bistra do blago opalescentna, bezbojna do žućkasta otopina koja ne sadrži čestice.
English: LEO Pharma GmbH
Croatian: LEO Pharma B.V.
English: The grey needle cap on the pre-filled syringe should not be removed while allowing to reach room temperature.
Croatian: Dok čekate da napunjena štrcaljka dosegne sobnu temperaturu, ne smije se uklanjati sivi zatvarač s igle.