FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: To avoid discomfort at the site of injection, at least 30 minutes should be allowed for the pre-filled syringe to reach room temperature before injecting.
Croatian: Da bi se izbjegla nelagoda na mjestu injiciranja, napunjenu štrcaljku potrebno je ostaviti najmanje 30 minuta da dosegne sobnu temperaturu prije injiciranja.
English: • if you have an infection now or often get infections
Croatian: • ako sad imate neku infekciju ili često imate infekcije • ako imate dugoročnu (kroničnu) infekciju
English: Following subcutaneous administrations of 210 mg, brodalumab exhibits non-linear pharmacokinetics typical for a monoclonal antibody that undergoes target-mediated drug disposition.
Croatian: Nakon potkožne primjene 210 mg, brodalumab pokazuje nelinearnu farmakokinetiku tipičnu za monoklonsko protutijelo koje se veže za ciljno mjesto.
English: The median time to maximum concentration (Tmax) was 3.0 days (range: 2.0 to 4.0 days) and the mean area under the concentration time curve to the last measurable concentration (AUClast) was 111 mcg*day/ml (SD = 64.4 mcg*day/ml).
Croatian: Srednje vrijeme do maksimalne koncentracije (Tmax) bilo je 3,0 dana (raspon: 2,0 do 4,0 dana), a srednja površina ispod krivulje vremenske koncentracije do posljednje mjerljive koncentracije (AUCzadnje) bila je 111 mcg*dan/ml (SD = 64,4 mcg*dan/ml).
English: Kyntheum should be prescribed to you by a doctor with experience in diagnosing and treating psoriasis.
Croatian: Kyntheum vam mora propisati liječnik s iskustvom u dijagnosticiranju i liječenju psorijaze.
English: If you stop using Kyntheum
Croatian: Ako prestanete primjenjivati Kyntheum
English: Talk to your doctor, pharmacist, or nurse before using Kyntheum:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Kyntheum:
English: The pre-filled syringe should not be warmed in any other way.
Croatian: Napunjena štrcaljka ne smije se ni na koji drugi način zagrijavati.
English: Kyntheum is used to treat a skin condition called “plaque psoriasis”, which causes inflammation and scaly plaque formation on the skin.
Croatian: Kyntheum se koristi za liječenje kožne bolesti pod nazivom "plak psorijaza", koja uzrokuje upalu i stvaranje ljuskastog plaka na koži.
English: Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Croatian: Kyntheum je indiciran za liječenje umjerene do teške plak psorijaze u odraslih koji su kandidati za sistemsku terapiju.
English: Approximately 30% of patients had previously received a biological and 12% of patients were biological failures.
Croatian: Približno 30% ispitanika prethodno je primalo biološku terapiju, a u 12% ispitanika biološka terapija nije bila uspješna.
English: In all three clinical trials, examination of age, gender, race, use of prior systemic or photo therapy, use of prior biologics, and biologic failures did not identify differences in response in all key endpoints [PASI 75, PASI 100, sPGA success (0 or 1), and sPGA clear (0)] to Kyntheum among these subgroups.
Croatian: U sva tri klinička ispitivanja pregled dobi, spola, rase, prethodne sistemske terapije ili fototerapije, prethodne uporabe bioloških lijekova ili neuspješnih bioloških terapija nije među tim podgrupama otkrio razlike u odgovoru u svim ključnim mjerama ishoda [PASI 75, PASI 100, prolazni sPGA
English: Active Crohn's disease.
Croatian: Aktivna Crohnova bolest.
English: • warm, red and painful skin, or a painful skin rash with blisters.
Croatian: • toplu, crvenu i bolnu kožu ili bolan kožni osip praćen mjehurićima.
English: Within each frequency grouping adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Table 1: List of adverse reactions in clinical trials System Organ Class
Croatian: Tablica 1: Popis nuspojava iz kliničkih ispitivanja
English: As an IgG2 human monoclonal antibody brodalumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Croatian: IgG2 ljudsko monoklonsko protutijelo, očekuje se da će se kataboličkim putevima razgraditi na male peptide i aminokiseline na sličan način kao endogeni IgG.
English: Kyntheum may be stored at room temperature (up to 25°C) once, in the outer carton, for a maximum single period of 14 days.
Croatian: Kyntheum se može čuvati na sobnoj temperaturi (do 25°C) jedanput, u vanjskom pakiranju, tijekom maksimalnog jednokratnog razdoblja od 14 dana.
English: • Do not use a Kyntheum pre-filled syringe if it has been dropped on a hard surface.
Croatian: • Nemojte upotrebljavati napunjenu štrcaljku lijeka Kyntheum ako je pala na tvrdu površinu.
English: EU/1/16/1155/001 Pack containing 2 pre-filled syringes
Croatian: EU/1/16/1155/001 Pakiranje sadrži 2 napunjene štrcaljke
English: Do not use this medicine after the expiry date which is stated on the outer carton and label of the prefilled syringe after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici napunjene štrcaljke iza oznake EXP.
English: There were no effects on peripheral blood immunophenotyping and the Tcell dependent antibody response assay.
Croatian: Nije bilo učinaka na imunofenotipizaciju periferne krvi i analizu odgovora protutijela ovisnih o limfocitima T.
English: In patients with moderate to severe plaque psoriasis, a single subcutaneous dose of 210 mg brodalumab increased the exposure of midazolam, a CYP3A4/3A5 substrate by 24%.
Croatian: U bolesnika s umjerenom do ozbiljnom plak psorijazom jedna potkožna doza od 210 mg brodalumaba povećala je izloženost midazolamu, supstratu CYP3A4/3A5, za 24%.
English: EU/1/16/1155/002 Multipack containing 6 (3 x 2) pre-filled syringes
Croatian: EU/1/16/1155/002 Višestruko pakiranje sadrži 6 (3 x 2) napunjenih štrcaljki
English: As a precautionary measure, it is preferable to avoid the use of Kyntheum in pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Kyntheum tijekom trudnoće.
English: The proportion of patients who achieved a Psoriasis Symptom Inventory (PSI) score of 0 (not at all) or 1 (mild) on every item (itch, burning, stinging, pain, redness, scaling, cracking and flaking) at Week 12 are shown in Table 2.
Croatian: Omjer bolesnika koji su prema upitniku za simptom psorijaze (PSI) imali rezultat 0 (bez simptoma) ili 1 (blago) za svaku stavku (svrbež, žarenje, peckanje, bol, crvenilo, ljuštenje, pucanje i ljuskanje) u 12. tjednu prikazani su u Tablici 2.
English: • Do not re-use the syringe.
Croatian: • Nemojte ponovno upotrebljavati štrcaljku.
English: In the event 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 praćenje znakova ili simptoma nuspojava u bolesnika kako bi se moglo odmah primijeniti odgovarajuće simptomatsko liječenje.
English: In cynomolgus monkeys, after weekly subcutaneous dosing of brodalumab at dose levels up to 90 mg/kg for 6 months, brodalumab-related effects were limited to injection site reactions and mucocutaneous inflammation that was consistent with pharmacologic modulation of host surveillance to commensal microflora.
Croatian: U makaki majmuna, nakon tjednih supkutanih doziranja brodalumaba u dozama do 90 mg/kg tijekom 6 mjeseci, učinci povezani s brodalumabom bili su ograničeni na reakcije na mjestu injektiranja i mukokutane upale u skladu s farmakološkom modulacijom nadzora komenzalne mikroflore nositelja.
English: Caution should be exercised when considering the use of Kyntheum in patients with a chronic infection or a history of recurrent infection.
Croatian: Potreban je oprez pri razmatranju primjene lijeka Kyntheum u bolesnika s kroničnom infekcijom ili poviješću opetovane infekcije.
English: One serious case of cryptococcal meningitis and one serious case of coccidioidies infection were observed in clinical trials (see section 4.4).
Croatian: U kliničkim istraživanjima opažen je jedan ozbiljan slučaj kriptokoknog meningitisa i jedan ozbiljan slučaj infekcije kokcidijama (vidjeti dio 4.4).
English: D. Prepare and clean the area where you will inject
Croatian: Pripremite i očistite mjesto injiciranja
English: - The other ingredients are proline, glutamate, polysorbate 20 and water for injections.
Croatian: - Drugi sastojci su prolin, glutamat, polisorbat 20 i voda za injekcije.
English: AMAGINE-2 and AMAGINE-3 were also active comparator (ustekinumab)-controlled.
Croatian: AMAGINE-2 i AMAGINE-3 kontrolirani su i aktivnim komparatorom (ustekinumabom).
English: There is limited data in patients with a history of Crohn's disease.
Croatian: Postoje ograničeni podaci o primjeni u bolesnika s poviješću Crohnove bolesti.
English: Brodalumab is expected to be mainly eliminated via catabolism and hepatic impairment is not expected to influence clearance.
Croatian: Očekuje se da će se brodalumab uglavnom eliminirati katabolički, pa se ne očekuje da će oštećenje funkcije jetre utjecati na klirens.
English: • if you have active Crohn's disease
Croatian: • ako imate aktivnu Crohnovu bolest
English: Pregnancy There are no or limited amount of data from the use of brodalumab in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni brodalumaba u trudnica ograničeni.
English: For single use only
Croatian: Supkutano Samo za jednokratnu uporabu
English: The ‘Instructions for Use' should be consulted for detailed instructions on administration of Kyntheum.
Croatian: U "Uputama za uporabu" potražite detaljne upute o primjeni lijeka Kyntheum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Kyntheum is administered by subcutaneous injection.
Croatian: Kyntheum se primjenjuje supkutanom injekcijom.
English: At Week 12, patients originally randomised to Kyntheum who achieved sPGA success (0 or 1) were re-randomised to receive either placebo or continued Kyntheum at their induction dose.
Croatian: Bolesnici izvorno randomizirani za liječenje lijekom Kyntheum koji su u 12. tjednu ostvarili prolazni sPGA rezultat (0 ili 1) bili su ponovno randomizirani za primanje placeba ili su nastavili primati Kyntheum pri indukcijskoj dozi.
English: Vaccination of infants with live vaccines following third trimester exposure to Kyntheum should be discussed with a physician (see also section 4.6).
Croatian: O imunizaciji dojenčadi živim cjepivima nakon izlaganja lijeku Kyntheum u trećem trimestru potrebno je raspraviti s liječnikom (vidjeti i dio 4.6).
English: As the metabolism of brodalumab is unknown in infants, benefit risk for exposure of the infant to live vaccines following third trimester exposure to Kyntheum should be discussed with a physician.
Croatian: S obzirom na to da nije poznat metabolizam brodalumaba u dojenčadi, potrebno je s liječnikom raspraviti o koristi i riziku izlaganja dojenčeta živim cjepivima nakon izlaganja lijeku Kyntheum u trećem tromjesečju.
English: Each syringe contains one 210 mg dose of Kyntheum.
Croatian: Jedna štrcaljka sadrži jednu dozu od 210 mg lijeka Kyntheum.
English: In a local tolerance test in rabbits, moderate to severe edema was observed after subcutaneous injection of a formulation containing brodalumab at the clinical concentration of 140 mg/ml.
Croatian: U lokalnom testiranju podnošljivosti u kunića opažen je umjeren do težak edem nakon potkožne injekcije formulacije koja sadrži brodalumab u kliničkoj koncentraciji od 140 mg/ml.
English: Do not try to inject Kyntheum until you or your caregiver have been shown how to inject Kyntheum by your doctor or nurse.
Croatian: Ne pokušavajte injicirati lijek Kyntheum dok Vama ili Vašem njegovatelju liječnik ne pokaže kako injicirati lijek Kyntheum.
English: Through Week 52, the exposure-adjusted event rates (per 100 patient-years) for infections were 114.6 for patients treated with Kyntheum and 118.1 for patients treated with ustekinumab.
Croatian: Do 52. tjedna stope događaja prilagođene izloženosti (na 100 bolesnika-godina) za infekcije bile su 114,6 za bolesnike koji su primali Kyntheum i 118,1 za bolesnike koji su primali ustekinumab.
English: The pre-filled syringe must not be shaken.
Croatian: Napunjena štrcaljka ne smije se tresti.
English: IL-17A, IL-17F and IL-17A/F heterodimer have pleiotropic activities including the induction of proinflammatory mediators such as IL-6, GROα, and G-CSF from epithelial cells, endothelial cells and fibroblasts that promote tissue inflammation.
Croatian: IL-17A, IL-17F i IL-17A/F heterodimer imaju pleiotropne aktivnosti, uključujući indukciju proinflamatornih posrednika kao što su IL-6, GROα i G-CSF iz epitelnih stanica, endotelnih stanica i fibroblasta koji potiču upalu tkiva.
English: Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C and IL-17E (also known as IL-25), resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis.
Croatian: Brodalumab je rekombinantno, potpuno ljudsko monoklonsko IgG2 protutijelo koje se s visokim afinitetom veže za ljudski IL-17RA i blokira biološke aktivnosti proinflamatornih citokina IL-17A, IL-17F, IL-17A/F heterodimera, IL-17C i IL-17E (također poznat kao IL-25), čime inhibira upalu i kliničke simptome povezane s psorijazom.
English: • if you have recently had or you or your baby are going to have a vaccination, see "Warnings and precautions" in section "2.
Croatian: • ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove • ako ste nedavno primili ili ćete Vi ili Vaše dijete primiti cjepivo pogledajte "Upozorenja i mjere opreza" u dijelu "2.
English: • plaster
Croatian: • flaster
English: Kyntheum is used in adults with moderate to severe plaque psoriasis affecting large areas of the body.
Croatian: Kyntheum se koristi u odraslih s umjerenim do teškim oblikom plak psorijaze koja zahvaća velika područja tijela.
English: Based on population pharmacokinetic modelling, the estimated mean steady-state volume of distribution of brodalumab was approximately 7.24 L.
Croatian: Na temelju populacijskog farmakokinetičkog modeliranja procijenjena srednja vrijednost volumena distribucije brodalumaba u stanju dinamičke ravnoteže iznosila je približno 7,24 l.
English: IL-17C has been shown to induce similar responses as IL-17A and IL-17F in keratinocytes.
Croatian: IL-17C inducira slične odgovore kao i IL-17A i IL-17F u keratinocitima.
English: Store in a refrigerator.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku.
English: The percentage of patients that at Week 12 achieved a DLQI (Dermatology Life Quality Index) score of 0 or 1 was 56%, 61%, 59% in the Kyntheum 210 mg group and 5%, 5%, 7% in the placebo group in AMAGINE-1, -2 and -3, respectively (adjusted p-value <0.001) and 44% in the ustekinumab groups (AMAGINE-2 and -3).
Croatian: Dermatology Life Quality Index, DLQI) 0 ili 1 bio je 56%, 61%, 59% u skupini Kyntheum 210 mg te 5%, 5%, 7% u skupini placeba za AMAGINE-1, -2 i -3, redom (korigirana p-vrijednost <0,001) te 44% u skupinama ustekinumaba (AMAGINE-2 i -3).
English: Population pharmacokinetic modelling predicted that serum brodalumab concentrations dropped below the quantification limit (0.05 mcg/ml) 63 days after discontinuation of steady-state dosing of brodalumab 210 mg administered every 2 weeks in 95% of the patients.
Croatian: Populacijsko farmakokinetičko modeliranje predvidjelo je da koncentracije brodalumaba u serumu padaju ispod granice kvantifikacije (0,05 mcg/ml) 63 dana nakon prekida doziranja 210 mg brodalumaba u stanju dinamičke ravnoteže svaka dva tjedna u 95% bolesnika.
English: After starting Kyntheum, tell your doctor, pharmacist or nurse immediately:
Croatian: Nakon početka liječenja lijekom Kyntheum odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru:
English: Store in a refrigerator (2°C to 8°C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: Patients with a history of Crohn's disease should be followed for signs and symptoms of active Crohn's disease.
Croatian: Crohnove bolesti potrebno je nadzirati pojavu znakova i simptoma aktivne Crohnove bolesti.
English: No dose recommendations can be made.
Croatian: Nije moguće dati preporuku o doziranju.
English: Uncommon Candida infections (including oral, genital, and oesophageal infections)
Croatian: Manje često kandidijaze (uključujući oralne, genitalne i ezofagealne infekcije)
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Croatian: Bolesnike je potrebno uputiti da se posavjetuju s liječnikom u slučaju pojave znakova ili simptoma koji upućuju na infekciju.
English: The majority of infections consisted of nasopharyngitis, upper respiratory tract infection, pharyngitis, urinary tract infections, bronchitis, and influenza, which did not necessitate treatment discontinuation.
Croatian: faringitis, infekcije urinarnog trakta, bronhitis i gripa zbog kojih nije bilo potrebno prekinuti liječenje.
English: IL-17 family cytokine levels have been reported to be increased in psoriasis.
Croatian: Razine citokina iz obitelji IL-17 prijavljene su povećane kod psorijaze.
English: Kyntheum has no influence on your ability to drive and use machines.
Croatian: Kyntheum nema utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
English: The exposureadjusted event rates (per 100 patient-years) for serious infections were 1.3 for patients treated with Kyntheum and 1.0 for patients treated with ustekinumab.
Croatian: Stope događaja prilagođene izloženosti (na 100 bolesnika-godina) za ozbiljne infekcije bile su 1,3 za bolesnike koji su primali Kyntheum i 1,0 za bolesnike koji su primali ustekinumab.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment.
Croatian: U bolesnika koji ne ostvare nikakav odgovor nakon 12 do 16 tjedana liječenja treba razmotriti prekid liječenja.
English: 1 ml solution contains 140 mg brodalumab.
Croatian: 1 ml otopine sadrži 140 mg brodalumaba.
English: Based on population pharmacokinetic modelling, the estimated accumulation ratio after 20 weeks of dosing is 2.5-fold.
Croatian: Na temelju populacijskog farmakokinetičkog modeliranja procjenjuje se da se omjer nakupljanja nakon 20 tjedana doziranja povećao 2,5 puta.
English: At Week 12, patients originally randomised to Kyntheum were re-randomised to receive either 210 mg every 2 weeks, or 140 mg every 2 weeks, or 140 mg every 4 weeks, or 140 mg every 8 weeks during the maintenance phase.
Croatian: U 12. su tjednu bolesnici izvorno randomizirani za liječenje lijekom Kyntheum ponovno randomizirani za primanje 210 mg ili 140 mg svaka dva tjedna, ili 140 mg svaka četiri tjedna, ili 140 mg svakih osam tjedana tijekom faze održavanja.
English: • if you have a history of Crohn's disease
Croatian: • ako imate povijest Crohnove bolesti
English: It is not known whether brodalumab passes into breast milk.
Croatian: Nije poznato izlučuje li se brodalumab u majčino mlijeko.
English: Adverse reactions from clinical trials (Table 1) are listed by MedDRA system organ class (SOC).
Croatian: Nuspojave iz kliničkih ispitivanja (Tablica 1) navedene su prema MedDRA klasifikaciji organskih sustava.
English: The observed pharmacokinetic parameters during steady-state (weeks 10-12) were: mean steady-state area under the concentration time curve over the dosing interval (AUCtau) was 227.4 mcg*day/ml (SD = 191.7 mcg*day/ml) corresponding to average concentration (Cav,ss) of 16.2 mcg/ml, mean Cmax was 20.9 mcg/ml (SD = 17.0 mcg/ml) and Week 12 mean minimum serum concentration (Ctrough) was 9.8 mcg/ml (SD = 11.2 mcg/ml).
Croatian: Opaženi farmakokinetički parametri tijekom stanja dinamičke ravnoteže (od 10. do 12. tjedna) su sljedeći: srednja površina ispod krivulje vremenske koncentracije u stanju dinamičke ravnoteže u intervalu doziranja (AUCtau) bila je 227,4 mcg*dan/ml (SD = 191,7 mcg*dan/ml), što odgovara prosječnoj koncentraciji (Cav,ss) od 16,2 mcg/ml, srednji Cmax bio je 20,9 mcg/ml (SD = 17,0 mcg/ml), a srednja minimalna koncentracija u serumu u 12. tjednu (Ctrough) 9,8 mcg/ml (SD = 11,2 mcg/ml).
English: If you forget to use Kyntheum
Croatian: Ako ste zaboravili primijeniti Kyntheum
English: If your doctor decides that you or a caregiver can give you injections at home, you 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, morat ćete proći obuku o ispravnom načinu pripreme i injiciranja lijeka Kyntheum.
English: Excipients: proline, glutamate, polysorbate 20 and water for injection.
Croatian: Pomoćne tvari: prolin, glutamat, polisorbat 20 i voda za injekcije.
English: Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Croatian: Kyntheum je namijenjen za primjenu pod vodstvom i nadzorom liječnika koji ima iskustva u dijagnosticiranju i liječenju psorijaze.
English: Treatment with Kyntheum in psoriasis patients has been shown to decrease levels of IL-17A and markers of cell proliferation and epidermal thickness in lesional skin biopsies to non-lesional skin biopsy levels up to 12 weeks post-treatment.
Croatian: Pokazalo se da liječenje bolesnika oboljelih od psorijaze lijekom Kyntheum smanjuje razine IL-17A i biljega proliferacije stanica i epidermalnu debljinu pri biopsijama kože s lezijama do razina biopsija kože bez lezija do 12 tjedana nakon liječenja.
English: Blocking IL-17RA inhibits IL-17 cytokine-induced responses resulting in normalization of inflammation in the skin.
Croatian: Blokiranjem IL-17RA inhibiraju se odgovori izazvani citokinom IL-17, čime se normalizira upala kože.
English: • Clean the area where you plan to inject with an alcohol wipe.
Croatian: • Očistite područje injiciranja vaticom natopljenom alkoholom.
English: • new syringe
Croatian: • novu štrcaljku
English: • Do not remove the finger grips.
Croatian: • Nemojte uklanjati hvatišta za prste.
English: Renal elimination of intact brodalumab, an IgG monoclonal antibody, is expected to be low and of minor consequence.
Croatian: Očekuje se da će bubrežna eliminacija nepromijenjenog brodalumaba, koji je IgG monoklonsko protutijelo, biti niska i od neznatne važnosti.
English: Busuttil Ltd Tel: +356 2144 7184
Croatian: E.J. Busuttil Ltd Tel: +356 2144 7184
English: Step 2: Getting ready to inject E. When you are ready to inject, pull the grey needle cap straight out and away from your body
Croatian: Kada ste spremni za injiciranje, povucite sivi zatvarač igle ravno od sebe
English: Instructions for Use: Kyntheum (brodalumab) Solution for injection in pre-filled syringe
Croatian: Upute za uporabu: Kyntheum (brodalumab) Otopina za injekciju u napunjenoj štrcaljki
English: Within each SOC, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava nuspojave su razvrstane prema učestalosti, na način da se prvo navode najčešće nuspojave.
English: Other side effects that have been reported Common side effects (may affect up to 1 in 10 people):
Croatian: Druge prijavljene nuspojave Česte nuspojave (mogu zahvatiti do 1 osobe na 10 ljudi):
English: It is normal to see a drop of liquid at the end of the needle.
Croatian: Ako primijetite kapljicu tekućine na kraju igle, to nije ništa neuobičajeno.