FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised when considering the use of Ilumetri in patients with a chronic infection or a history of recurrent or recent serious infection.
Croatian: Potreban je oprez prilikom razmatranja primjene lijeka Ilumetri u bolesnika s kroničnom infekcijom ili anamnezom ponavljane ili nedavne ozbiljne infekcije.
English: If a patient develops a serious infection, the patient should be closely monitored and Ilumetri should not be administered until the infection resolves.
Croatian: Ako bolesnik razvije ozbiljnu infekciju, nužno ga je pomno pratiti, a Ilumetri se ne smije primjeniti prije suzbijanja infekcije.
English: 08740 Sant Andreu de la Barca, Barcelona, Spain
Croatian: 08740 Sant Andreu de la Barca, Barcelona, Španjolska
English: Prior to initiating treatment with Ilumetri, patients should be evaluated for tuberculosis (TB) infection.
Croatian: Prije započinjanja liječenja lijekom Ilumetri potrebno je učiniti procjenu bolesnika na moguću infekciju tuberkulozom (TBC).
English: In pooled Phase 2b and Phase 3 analyses 7.3% of Ilumetri-treated patients developed antibodies to Ilumetri.
Croatian: U objedinjenim analizama faze IIb i faze III, u 7,3% bolesnika liječenih lijekom Ilumetri došlo je do razvoja protutijela na Ilumetri.
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur.
Croatian: Bolesnike je potrebno uputiti da zatraže savjet liječnika ako se pojave znakovi ili simptomi koji upućuju na pojavu klinički relevantne kronične ili akutne infekcije.
English: Ilumetri has no or negligible influence on the ability to drive and use machines.
Croatian: Ilumetri ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Read the Ilumetri Package Leaflet to learn more about your medicine.
Croatian: • Pročitajte uputu o lijeku kako biste saznali više o svojem lijeku.
English: No apparent association between the development of antibodies to Ilumetri to lower efficacy and the development of treatment emergent adverse events was observed.
Croatian: Nije zabilježena vidljiva povezanost između razvoja protutijela na Ilumetri i smanjenja djelotvornosti, niti je zabilježena pojava štetnih događaja nastalih tijekom liječenja.
English: • Gently pinch your skin at the chosen injection site.
Croatian: • Nježno uhvatite kožu u nabor na odabranom mjestu ubrizgavanja.
English: The instructions for using the pre-filled syringes, included with the package leaflet, must be followed carefully.
Croatian: Upute za primjenu napunjenih štrcaljki, navedene uz uputu o lijeku, moraju se pažljivo slijediti.
English: The safety and efficacy of Ilumetri in children and adolescents under 18 years of age has not yet been established and therefore Ilumetri is not recommended for use in children or adolescents.
Croatian: Sigurnost i djelotvornost lijeka Ilumetri u djece i adolescenata mlađih od 18 godina još nije utvrđena i zato se primjena lijeka Ilumetri ne preporučuje u djece ili adolescenata.
English: • After inserting the needle, let go of the skin gently.
Croatian: • Nakon umetanja igle, lagano otpustite kožu.
English: Other evaluated outcomes included the proportion of patients who achieved PASI 90, PASI 100, the proportion of patients with DLQI 0 or 1, and maintenance of efficacy up to 52/64 weeks.
Croatian: Drugi procijenjeni ishodi uključivali su udio bolesnika koji su postigli PASI 90, PASI 100, udio bolesnika s DLQI od 0 ili 1 i održavanje djelotvornosti do 52/64 tjedna.
English: A total of 1,768 patients were evaluated (705 patients on 100 mg, 708 patients on 200 mg and 355 patients on placebo).
Croatian: Procijenjeno je ukupno 1768 bolesnika (705 bolesnika koji su primali dozu od 100 mg, 708 bolesnika koji su primali dozu od 200 mg i 355 bolesnika koji su primali placebo).
English: The safety and efficacy of Ilumetri in children and adolescents below the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Ilumetri u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: If you have administered more Ilumetri than you should or the dose has been administered sooner than according to your doctor's prescription, tell your doctor.
Croatian: Ako ste primijenili više lijeka Ilumetri nego što ste trebali, ili je doza dana prije nego što je to propisao liječnik, obavijestite liječnika o tome.
English: Take a pack from the refrigerator (if stored in the refrigerator)
Croatian: PRIPREMA 1. Izvadite kutiju iz hladnjaka (ako ste lijek čuvali u hladnjaku)
English: In a pre- and postnatal development toxicity study in monkeys, no related increase in pregnancy loss was observed at exposures up to 85 times the human exposure at the recommended dose.
Croatian: U studijama toksičnosti vezane uz prenatalni i postnatalni razvoj majmuna, nije zabilježeno povećanje gubitka trudnoće pri izloženosti do 85 puta većoj od izloženost od u ljudi pri preporučenoj dozi.
English: - DO NOT use if the liquid contains visible particles or the syringe is damaged.
Croatian: - NEMOJTE koristiti ako tekućina sadrži vidljive čestice ili je štrcaljka oštećena.
English: • While holding the body of the pre-filled syringe, remove the needle cover as shown and discard.
Croatian: • Držeći tijelo napunjene štrcaljke, skinite pokrov igle kako je prikazano na slici i odložite ga.
English: Steady-state is achieved by 16 weeks with the clinical regimen of 0, 4, and every 12 weeks thereafter, with 1.1-fold accumulation in exposure between week-1 and week-12 independent of dose.
Croatian: Stanje dinamičke ravnoteže postignuto je do 16. tjedna s kliničkim režimom primjene u tjednu 0., 4., a zatim svakih 12 tjedana, s 1,1 puta većom akumulacijom kod izloženosti između 1. tjedna i 12. tjedna, neovisno o dozi.
English: Small-molecule metabolic pathways (e.g., CYP450 enzymes, glucuronosyltransferases) do not contribute to its clearance.
Croatian: Metabolički putovi malih molekula (npr. enzima CYP450, glukuronoziltransferaze) ne doprinose njegovom klirensu.
English: Ronda General Mitre, 151 08022 Barcelona Spain
Croatian: Ronda General Mitre, 151 08022 Barcelona Španjolska
English: The pre-filled syringe should be taken out of the refrigerator 30 minutes before injecting to allow it to reach room temperature (up to 25ºC).
Croatian: Napunjenu štrcaljku treba izvaditi iz hladnjaka 30 minuta prije injekcije kako bi se omogućilo da postigne sobnu temperature (do 25 ºC).
English: Choose an injection site
Croatian: Izaberite mjesto ubrizgavanja
English: Patients treated with Ilumetri should not receive live vaccines during treatment and for at least 17 weeks after treatment (see section 4.5).
Croatian: Bolesnici liječeni lijekom Ilumetri ne smiju tijekom liječenja i najmanje 17 tjedana nakon liječenja primati živa cjepiva (vidjeti dio 4.5).
English: Single use only.
Croatian: Samo za jednokratnu primjenu.
English: Important points to know
Croatian: Važne napomene
English: Clearance values range from 2.04 to 2.52 mL/day/kg and the half-life was 23.4 days (23% CV) in subjects with plaque psoriasis.
Croatian: Vrijednosti klirensa kreću se u rasponu u 2,04 do 2,52 ml/dan/kg, a poluvijek je bio 23,4 dana (23% CV) u ispitanika s plak psorijazom.
English: Studies reSURFACE 1 and reSURFACE 2 assessed the changes from baseline at Week 12 in the two coprimary endpoints: 1) PASI 75 and 2) PGA of “0” (cleared) or “1” (minimal), with at least a 2-point improvement from baseline.
Croatian: U ispitivanjima reSURFACE 1 i reSURFACE 2 procijenjene su promjene u 12. tjednu u odnosu na početnu vrijednost za dvije koprimarne mjere ishoda: 1) PASI 75 i 2) PGA od „0“ (čisto) ili „1“ (minimalno), s najmanje 2 boda poboljšanja u odnosu na početnu vrijednost.
English: Ronda General Mitre, 151 08022 Barcelona, Spain
Croatian: Ronda General Mitre, 151 08022 Barcelona, Španjolska
English: Write down the date of removal from the refrigerator in the space provided on the outer carton and appropriate discard date.
Croatian: Zapišite datum vađenja iz hladnjaka u predviđeni prostor na vanjskom pakiranju i odgovarajući datum bacanja.
English: Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled syringe after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici napunjene štrcaljke iza oznake „EXP”.
English: No data are available with the concomitant use of Ilumetri and live vaccines.
Croatian: Nisu dostupni podaci o istodobnoj primjeni lijeka Ilumetri i živih cjepiva.
English: c No imputation for missing data.
Croatian: c Nema imputacije za podatake koji nedostaju.
English: • Dispose of used syringe in a sharps disposal container right away after use and before injecting a second syringe.
Croatian: • Odložite upotrijebljenu štrcaljku u spremnik za odlaganje oštrih predmeta odmah nakon primjene i prije ubrizgavanja druge štrcaljke.
English: If a serious hypersensivity reaction occurs, administration of Ilumetri should be discontinued immediately and appropriate therapy initiated.
Croatian: U slučaju pojave ozbiljne reakcije preosjetljivosti, nužno je odmah prekinuti primjenu lijeka Ilumetri i započeti odgovarajuću terapiju.
English: - If you have recently had or plan to have a vaccination.
Croatian: - ako ste nedavno cijepljeni ili se planirate cijepiti.
English: Two neonatal deaths from monkeys administered tildrakizumab at maternal exposure of 85 times the human exposure at the recommended dose were attributed to possible viral infection and considered of uncertain relationship to the treatment.
Croatian: Dva uginuća novorođenih majmuna koji su dobivali tildrakizumab pri izloženosti majke koja je bila 85 puta veća od izloženosti u ljudi pri preporučenoj dozi, pripisana su mogućoj virusnoj infekciji i smatralo se da njihova povezanost s primjenom lijeka nije sigurna.
English: • The pre-filled syringes must not be shaken.
Croatian: • Napunjene štrcaljke se ne smiju tresti.
English: After proper training in subcutaneous injection technique, you may inject Ilumetri yourself if your doctor determines that it is appropriate.
Croatian: Nakon odgovarajuće obuke o tehnici davanja potkožne injekcije, sami si možete ubrizgati Ilumetri ako Vaš liječnik utvrdi da je to primjereno.
English: Ilumetri should not be injected into areas where the skin is affected by plaque psoriasis or is tender, bruised, red, hard, thick, or scaly.
Croatian: Ilumetri se ne smije ubrizgavati na područja kože zahvaćena plak psorijazom ili područja koja su osjetljiva na dodir, prekrivena modricama, crvena, tvrda, zadebljana ili prekrivena ljuskama.
English: Available toxicological data in cynomolgus monkey have shown negligible levels of Ilumetri in milk on postnatal day 28 (see section 5.3).
Croatian: Raspoloživi toksikološki podaci u makaki majmuna ukazuju na zanemarive razine lijeka Ilumetri u mlijeku 28 dana nakon okota (vidjeti dio 5.3).
English: Tildrakizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 50 mg to 400 mg following subcutaneous administration, with clearance being independent of dose.
Croatian: Tildrakizumab je pokazao farmakokinetiku proporcionalnu dozi u ispitanika s plak psorijazom u rasponu doze od 50 mg do 400 mg nakon potkožne primjene, s klirensom koji nije ovisio o dozi.
English: Use the syringe within 30 days after taking it out of the refrigerator or by the expiry date whichever occurs first.
Croatian: Upotrijebite štrcaljku u roku od 30 dana nakon vađenja iz hladnjaka ili do roka valjanosti, ovisno što je prije.
English: Thereafter, resume dosing at the regularly scheduled interval.
Croatian: Nakon toga treba nastaviti prema uobičajenom rasporedu primjene.
English: Number of patients PASI 75a (%)
Croatian: 52,4c reSURFACE2 Broj bolesnika PASI 75a (%)
English: • Remove the pre-filled syringe from the carton when ready to inject.
Croatian: • Izvadite napunjenu štrcaljku iz kutije kada ste spremni za ubrizgavanje.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use an effective method of contraception whilst having treatment with Ilumetri and for at least 17 weeks after treatment.
Croatian: Ako ste žena u reproduktivnoj dobi (tj. možete zatrudnjeti), preporučuje se izbjegavanje trudnoće i obavezna primjena učinkovite metode kontracepcije tijekom liječenja lijekom Ilumetri i najmanje 17 tjedana nakon liječenja.
English: Do not shake or freeze the pre-filled syringe.
Croatian: Nemojte tresti ni zamrzavati napunjenu štrcaljku.
English: Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak vezan uz reproduktivnu toksičnost (vidjeti dio 5.3).
English: Tildrakizumab was shown to distribute across the placental barrier.
Croatian: Pokazalo se da se tildrakizumab distribuira kroz placentalnu barijeru.
English: - DO NOT inject into scars, stretch marks, or blood vessels.
Croatian: - NEMOJTE ubrizgavati u ožiljke, strije ni krvne žile.
English: The liquid should be clear.
Croatian: Otopina treba biti bistra.
English: Using Ilumetri will benefit you by improvements of skin clearance and reducing your symptoms.
Croatian: Primjena lijeka Ilumetri Vam pomaže tako što smanjuje kožne promjena i ublažava simptome.
English: 1 mL solution in a type I glass pre-filled syringe with stainless steel 29G x ½” needle, covered with a needle shield and rigid needle shield of polypropylene with a fluropolymer lamination, plunger stopper assembled in a passive safety device.
Croatian: 1 ml otopine u napunjenoj štrcaljki (staklo tip 1) s iglom od nehrđajućeg čelika 29G x ½” i pokrovom za iglu, krutim štitnikom za iglu od polipropilena s fluorpolimernim slojem, čepom klipa uklopljenim u pasivni sigurnosni uređaj.
English: It is preferable to avoid the use of Ilumetri in pregnancy.
Croatian: Preporučuje se izbjegavati primjenu lijeka Ilumetri u trudnoći.
English: No harmful effects were noted in neonates at maternal exposures up to 9 times the human exposure at the recommended dose.
Croatian: Nisu zabilježeni štetni učinci u novorođenčadi majmuna pri izloženost majke do 9 puta većoj od izloženosti u ljudi pri preporučenoj dozi.
English: In these studies, patients were randomised to either placebo or tildrakizumab (including 200 mg and 100 mg at 0, 4 and every twelve weeks thereafter [Q12W]), up to 52 or 64 weeks.
Croatian: U tim su ispitivanjima bolesnici randomizirani za primanje placeba ili tildrakizumaba (uključujući doze od 200 mg i 100 mg u tjednu 0., 4., a zatim svakih 12 tjedana [Q12W]), do 52 ili 64 tjedna.
English: As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy.
Croatian: Kao mjeru predostrožnosti, preporučuje se izbjegavati primjenu lijeka Ilumetri tijekom trudnoće.
English: Live vaccines should not be given concurrently with Ilumetri (see section 4.4).
Croatian: Živa cjepiva ne smiju se davati istodobno s lijekom Ilumetri (vidjeti dio 4.4).
English: No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of tildrakizumab was conducted.
Croatian: Nije provedeno formalno ispitivanje učinka oštećenja jetre ili bubrega na farmakokinetiku tildrakizumaba.
English: Furthermore, Ilumetri does not impact the pharmacokinetics of concomitant medicines metabolized by CYP450 enzymes either through direct or indirect mechanisms (see section 5.2).
Croatian: Nadalje, Ilumetri ne utječe na farmakokinetiku istodobno primjenjivanih lijekova koje metaboliziraju enzimi CYP450, bilo direktnim ili indirektnim mehanizmima (vidjeti dio 5.2).
English: After taking a pre-filled syringe from the refrigerator, wait approximately 30 minutes to allow the Ilumetri solution in the syringe to reach room temperature (up to 25ºC).
Croatian: Nakon vađenja napunjene štrcaljke iz hladnjaka, pričekajte oko 30 minuta da otopina lijeka Ilumetri u štrcaljki dosegne sobnu temperaturu (do 25°C).
English: Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Croatian: Ilumetri je indiciran za liječenje odraslih s umjerenom do teškom plak psorijazom, koji su kandidati za sistemsku terapiju.
English: Pre-treatment evaluation for tuberculosis
Croatian: Procjena na tuberkulozu prije početka liječenja
English: Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Croatian: Tildrakizumab je humano monoklonsko protutijelo IgG1/κ koje se proizvodi tehnologijom rekombinantne DNK-a u stanicama jajnika kineskog hrčka (engl.
English: Animal carcinogenicity studies have not been conducted with tildrakizumab.
Croatian: Nisu provedena ispitivanja kancerogenosti u životinja za lijek tildrakizumab.
English: Patients should be instructed to inject the full amount of Ilumetri according to the instructions provided in the package leaflet.
Croatian: Bolesnike je nužno uputiti da si injiciraju svu količinu lijeka Ilumetri u skladu s uputama navedenima u uputi o lijeku.
English: Infections and infestations Upper respiratory tract infectionsa Very common Nervous system disorders Headache
Croatian: Infekcije i infestacije infekcije gornjeg respiratornog traktaa vrlo često
English: Following administration of 100 mg or 200 mg of tildrakizumab, subjects who are 65 years or older (n=81 and n=82, respectively) had a similar tildrakizumab clearance as compared to subjects less than 65 years old (n=884).
Croatian: Nakon primjene tildrakizumaba u dozi od 100 mg ili 200 mg, ispitanici u dobi od 65 godina ili stariji (n=81, odnosno n=82) imali su sličan klirens tildrakizumaba u usporedbi s ispitanicima mlađima od 65 godina (n=884).
English: EU/1/18/1323/002 2 pre-filled syringes
Croatian: EU/1/18/1323/002 2 napunjene štrcaljke
English: In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment be instituted immediately.
Croatian: U slučaju predoziranja preporučuje se praćenje bolesnika zbog moguće pojave znakova i simptoma nuspojava i hitno uvođenje odgovarajućeg simptomatskog liječenja.
English: If you forget to use Ilumetri
Croatian: Ako zaboravite primijeniti Ilumetri
English: Therefore, tildrakizumab does not impact the pharmacokinetics of concomitant medicines metabolized by CYP enzyme (see section 4.5).
Croatian: Tildrakizumab stoga ne utječe na farmakokinetiku istodobno primjenjenih lijekova koji se metaboliziraju putem CYP enzima (vidjeti dio 4.5).
English: After proper training in subcutaneous injection technique, patients may self-inject Ilumetri if a physician determines that it is appropriate.
Croatian: Nakon odgovarajuće obuke u tehnici primjene potkožne injekcije, bolesnici si mogu samostalno injicirati Ilumetri, ako liječnik utvrdi da je to primjereno.
English: Improvements were maintained over time with at week 52, 63.7% (100 mg) and 73.3% (200 mg) in reSURFACE 1, and 68.8% (100 mg) and 72.4% (200 mg) in reSURFACE 2 of patients who were PASI 75 responders at week 28 having a DLQI of 0 or 1.
Croatian: Poboljšanja su se održala tijekom vremena, u 63,7% (100 mg) i 73,3% (200 mg) bolesnika u 52. tjednu u ispitivanju reSURFACE 1 i 68,8 % (100 mg) i 72,4% (200 mg) bolesnika u ispitivanju reSURFACE 2 u 28. tjednu koji su ostvarili odgovor PASI 75 s rezultatom DLQI od 0 ili 1.
English: Almirall B.V. Tel: +31 (0)307991155
Croatian: Tel: +31 (0)307991155
English: Pack size of 1 pre-filled syringe or 2 pre-filled syringes.
Croatian: Veličina pakiranja: 1 napunjena štrcaljka ili 2 napunjene štrcaljke.
English: Population pharmacokinetic analysis indicated that age did not have a clinically significant influence on the clearance of tildrakizumab in adult subjects with plaque psoriasis.
Croatian: Populacijska farmakokinetička analiza je ukazala da ne postoji klinički značajan utjecaja dobi na klirens tildrakizumaba u odraslih ispitanika s plak psorijazom.
English: Once removed from the refrigerator and stored under these conditions, discard after 30 days or by the expiry date printed on the container, whichever occurs first.
Croatian: Nakon vađenja iz hladnjaka i čuvanja u ovim uvjetima, lijek bacite nakon isteka 30 dana ili do isteka roka valjanosti otisnutog na spremniku, ovisno o tome što bude prije.
English: Each pre-filled syringe is for single use only.
Croatian: Svaka napunjena štrcaljka je namijenjena samo za jednokratnu primjenu.
English: If any of these side effects becomes severe, tell your doctor or pharmacist.
Croatian: Ako bilo koja od navedenih nuspojava postane teška, obavijestite svojeg liječnika ili ljekarnika.
English: Inject the full amount of tildrakizumab according to the instructions for use provided in the package leaflet.
Croatian: Potrebno je injicirati svu količinu tildrakizumaba u skladu s uputama za uporabu navedenim u uputi o lijeku.
English: Injection sites should be alternated.
Croatian: Potrebno je mijenjati mjesta primjene injekcije.
English: Adverse reactions (Table 1) are listed by MedDRA system organ class (SOC) 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); and not known (cannot be estimated from available data).
Croatian: sukladno sljedećem: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko
English: Unopened pre-filled syringe of Ilumetri may be removed from the refrigeration and stored up to 25°C for a single period of up to 30 days.
Croatian: Neotvorena napunjena štrcaljka lijeka Ilumetri može se izvaditi iz hladnjaka i čuvati na temperaturi do 25 °C najdulje 30 dana.
English: In case your dose is 200 mg, you will need to use 2 pre-filled syringes each time you administer the product.
Croatian: U slučaju doze od 200 mg kod svake primjene lijeka bit će Vam potrebne 2 napunjene štrcaljke.
English: Patients randomised to tildrakizumab 100 mg or tildrakizumab 200 mg in Part 1 who were PASI 75 responders at week 28 (reSURFACE1).
Croatian: Bolesnici randomizirani za tildrakizumab 100 mg ili tildrakizumab 200 mg u 1. dijelu koji su u imali klinički odgovor s ostvarenim PASI 75 u 28. tjednu (reSURFACE1).
English: Concomitant medicines affecting Ilumetri pharmacokinetics are not expected since it is cleared from the body by general protein catabolism processes with no contribution of cytochrome P450 (CYP450) enzymes, and it is not eliminated by renal or hepatic pathways.
Croatian: Ne očekuje se utjecaj istodobno primjenjivanih lijekova na farmakokinetiku lijeka Ilumetri zato što se on eliminira iz tijela uobičajenim procesom razgradnje bjelančevina, bez sudjelovanja enzima citokroma P450 (CYP450) i ne izlučuje se putem bubrega ili jetre.
English: SMALL IMMEDIATE PACKAGING UNITS LABEL - PRE-FILLED SYRINGE
Croatian: MALO UNUTARNJE PAKIRANJE NALJEPNICA - NAPUNJENA ŠTRCALJKA
English: - Choose a different location for the second injection.
Croatian: Za sljedeću injekciju izaberite drugo mjesto.
English: Ilumetri is administered by subcutaneous injection.
Croatian: Ilumetri se daje supkutanom injekcijom.
English: The recommended dose of Ilumetri is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter.
Croatian: Preporučena doza lijeka Ilumetri je 100 mg potkožnom injekcijom u 0. i 4. tjednu, a zatim svakih 12 tjedana.
English: PGA of “clear” or “minimal” with ≥2
Croatian: PGA „čisto“ ili „minimalno“ s poboljšanjem od ≥2 u odnosu na početnu vrijednosta (%)
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na plodnost (vidjeti dio 5.3).
English: INSTRUCTIONS FOR USE
Croatian: UPUTE ZA PRIMJENU
English: If you stop using Ilumetri
Croatian: Ako prestanete primjenjivati Ilumetri