FrancophonIA/ELRC3.0 huggingface dataset:
English: b. CRh*was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre) and no relapse within 28 days.
Croatian: b. CRh* je definiran kao koštana srž M1 (≤ 5% blasta u koštanoj srži), bez dokaza cirkulirajućih blasta ili ekstramedularne bolesti, uz djelomični oporavak broja stanica u perifernoj krvi (trombociti > 50 000/mikrolitar i apsolutni broj neutrofila > 500/mikrolitar) i bez recidiva unutar 28 dana.
English: 5 mcg/m 2/day via continuous infusion (not to exceed 9 mcg/day)
Croatian: 5 µg/m 2/dan putem kontinuirane infuzije (ne smije se prekoračiti 9 µg/dan)
English: Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-cell precursor ALL
Croatian: Tablica 2. Rezultati djelotvornosti u bolesnika u dobi od ≥ 18 godina s recidivirajućim ili refraktornim Philadelphia kromosom negativnim ALL-om prekursora B limfocita
English: Grade 3 Interrupt BLINCYTO until resolved, then restart BLINCYTO at 9 mcg/day.
Croatian: Prekinite primjenu lijeka BLINCYTO do oporavka, zatim ponovno započnite primjenu lijeka BLINCYTO u dozi od 9 µg/dan.
English: Management of infections may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Croatian: Zbrinjavanje infekcije može zahtijevati bilo privremeni prekid bilo trajni prekid primjene lijeka BLINCYTO (vidjeti dio 4.2).
English: For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 15 mcg/m2/day dose
Croatian: Za bolesnike tjelesne težine manje od 45 kg: volumeni otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju, otopine (stabilizatora) i rekonstituirane otopine lijeka BLINCYTO koji je potrebno dodati u infuzijsku vrećicu za dozu od 15 µg/m2/dan
English: For patients weighing greater than or equal to 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag
Croatian: Za bolesnike tjelesne težine 45 kg ili veće: volumeni otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju, otopine (stabilizatora) i rekonstituiranog lijeka BLINCYTO koji je potrebno dodati u infuzijsku vrećicu
English: For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 5 mcg/m2/day dose
Croatian: Za bolesnike tjelesne težine manje od 45 kg: volumeni otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju, otopine (stabilizatora) i rekonstituirane otopine lijeka BLINCYTO koji je potrebno dodati u infuzijsku vrećicu za dozu od 5 µg/m2/dan
English: 5 mcg/m2/day via continuous infusion (not to exceed 9 mcg/day)
Croatian: 5 µg/m2/dan putem kontinuirane infuzije (ne smije se prekoračiti 9 µg/dan)
English: Grade 3 If clinically relevant, interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 9 mcg/day.
Croatian: Ako je klinički značajno, prekinite primjenu lijeka BLINCYTO dok se ne postigne barem 1. stupanj (blago), zatim ponovno započnite primjenu lijeka BLINCYTO u dozi od 9 µg/dan.
English: BLINCYTO dose calculations are based on a usual overfill volume of 265 to 275 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Izračuni doze za BLINCYTO temelje se na uobičajenoj prisutnosti dodatnog volumena (overfill) otopine natrijeva klorida 9 mg/ml (0,9%) za injekcije u vrećici tj. volumenu od 265 do 275 ml. o Koristite samo poliolefinske vrećice, PVC vrećice bez dietilheksilftalata (DEHP) ili etilvinilacetat (EVA) infuzijske vrećice/kasete za pumpu.
English: Interrupt BLINCYTO until no more than grade 1 (mild) and for at least 3 days, then restart BLINCYTO at 5 mcg/m2/day.
Croatian: Prekinite primjenu lijeka BLINCYTO dok se ne postigne barem 1. stupanj (blago) i kroz najmanje 3 dana, zatim ponovno započnite primjenu lijeka BLINCYTO u dozi od 5 µg/m2/dan.
English: (%) [95% CI] CRh*, n1/n2d (%) [95% CI] Median relapse e-free survival (RFS)
Croatian: (%) [95% CI] CRh*, n1/n2
English: Solution (stabiliser): citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Croatian: Otopina (stabilizator): citratna kiselina hidrat (E330), lizinklorid, polisorbat 80, natrijev hidroksid i voda za injekcije.
English: - The solution (stabiliser) contains citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Croatian: - Otopina (stabilizator) sadrži citratnu kiselinu hidrat (E330), lizinklorid, polisorbat 80, natrijev hidroksid i vodu za injekcije.
English: Hepatic impairment
Croatian: Encefalopatija Afazija
English: a. CR was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre) and no relapse within 28 days.
Croatian: CR je definiran kao koštana srž M1 (≤ 5% blasta u koštanoj srži), bez dokaza cirkulirajućih blasta ili ekstramedularne bolesti, uz potpuni oporavak broja stanica u perifernoj krvi (trombociti > 100 000/mikrolitar i apsolutni broj neutrofila > 1000/mikrolitar) i bez recidiva unutar 28 dana.
English: Patient weight
Croatian: Povišena tjelesna težina
English: Management of these events may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Croatian: Zbrinjavanje ovih događaja može zahtijevati bilo privremeni prekid bilo trajni prekid primjene lijeka BLINCYTO (vidjeti dio 4.2).
English: Grade 3 Interrupt BLINCYTO until no more than grade 1 (mild) and for at least 3 days, then restart BLINCYTO at 9 mcg/day.
Croatian: Prekinite primjenu lijeka BLINCYTO dok se ne postigne barem 1. stupanj (blago) i kroz najmanje 3 dana, zatim ponovno započnite primjenu lijeka BLINCYTO u dozi od 9 µg/dan.
English: c. CRi (complete remission with incomplete haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/microlitre or ANC > 1,000/microlitre).
Croatian: CRi (potpuna remisija uz nepotpun hematološki oporavak; od eng. complete remission with incomplete haematologic recovery) je definiran kao ≤ 5% blasta u koštanoj srži, bez dokaza bolesti, uz nepotpuni oporavak broja stanica u perifernoj krvi (trombociti > 100 000/mikrolitar ili apsolutni broj neutrofila [ABN] > 1000/mikrolitar).
English: CRh* (complete remission with partial haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre).
Croatian: b. CRh* (potpuna remisija uz djelomičan hematološki oporavak; od eng. complete remission with partial haematologic recovery) je definiran kao ≤ 5% blasta u koštanoj srži, bez dokaza bolesti, uz djelomični oporavak broja stanica u perifernoj krvi (trombociti > 50 000/mikrolitar i apsolutni broj neutrofila [ABN] > 500/mikrolitar).
English: Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL)
Croatian: Tablica 3. Rezultati djelotvornosti u bolesnika u dobi od ≥ 18 godina s recidivirajućim ili refraktornim Philadelphia kromosom negativnim ALL-om prekursora limfocita B n (%) n = 189
English: CR was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre).
Croatian: CR je definiran kao ≤ 5% blasta u koštanoj srži, bez dokaza bolesti, uz potpuni oporavak broja stanica u perifernoj krvi (trombociti > 100,000/mikrolitar i apsolutni broj neutrofila > 1,000/mikrolitar).
English: Neutropenia Thrombocytopenia Leukopenia
Croatian: Neutropenija Trombocitopenija
English: CRh* was defined as ≤ 5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre).
Croatian: CRh* je definiran kao ≤ 5% blasta u koštanoj srži, bez dokaza bolesti, uz djelomični oporavak broja stanica u perifernoj krvi (trombociti > 50,000/mikrolitar i apsolutni broj neutrofila > 500/mikrolitar).
English: Interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 5 mcg/m2/day.
Croatian: Prekinite primjenu lijeka BLINCYTO dok se ne postigne barem 1. stupanj (blago), zatim ponovno započnite primjenu lijeka BLINCYTO u dozi od 5 µg/m2/dan.
English: Tumour lysis syndrome (TLS), which may be life-threatening or fatal (grade ≥ 4) has been observed in patients receiving BLINCYTO.
Croatian: U bolesnika u kojih se primjenjuje BLINCYTO opažen je sindrom lize tumora (TLS, od eng. tumour lysis syndrome), koji može biti opasan po život ili imati smrtan ishod (stupanj ≥ 4).
English: 1 vial of solution (stabiliser).
Croatian: 1 bočica otopine (stabilizatora).
English: • A warning message for HCPs treating the patient at any time, including emergency conditions, that the patient is using BLINCYTO
Croatian: • Upozorenje za zdravstvenog radnika koji liječi bolesnika u bilo kojem trenutku,
English: CR
Croatian: SN
English: BLINCYTO (N = 271)
Croatian: (N = 271)
English: PC SN NN
Croatian: BSA (m
English: Citric acid monohydrate (E330) Lysine hydrochloride Polysorbate 80
Croatian: Citratna kiselina hidrat (E330) Lizinklorid
English: MRD (minimum residual disease) response was defined as MRD by PCR or flow cytometry < 1 x 10 f. Patients who achieved CR/CRh*/CRi and had an evaluable post baseline MRD assessment.
Croatian: Bolesnici koji su postignuli CR/CRh*/CRi i imali su procjenjivu naknadnu MRB procjenu.
English: 2.5 mL/hour
Croatian: 2,5 ml/h
English: Fertility
Croatian: Parestezija
English: Nausea
Croatian: Kašalj
English: Peripheral B-cell counts decreased rapidly to an undetectable level during treatment at doses ≥ 5 mcg/m 2/day or ≥ 9 mcg/day in the majority of patients.
Croatian: U većine bolesnika tijekom liječenja dozama od ≥ 5 µg/m2/dan ili ≥ 9 µg/dan broj perifernih B limfocita brzo se smanjio do razine koju nije bilo moguće detektirati.
English: • coughing with phlegm
Croatian: razine MRB-a prema PCR-u.
English: (not to exceed 20 mg) should be administered orally or intravenously 6 to 12 hours prior to the start of BLINCYTO (cycle 1, day 1).
Croatian: U pedijatrijskih bolesnika 6 do 12 sati prije započinjanja terapije lijekom BLINCYTO (1. ciklus, 1. dan) mora se oralno ili intravenski primijeniti 10 mg/m deksametazona (ne smije se prekoračiti 20 mg).
English: rd
Croatian: Dob
English: Hypertension Flushing
Croatian: Tahikardija Krvožilni poremećaji Hipotenzija
English: BLINCYTO 38.5 mcg powder for concentrate blinatumomab
Croatian: BLINCYTO 38,5 µg prašak za koncentrat blinatumomab i.v. nakon rekonstitucije i razrjeđivanja
English: • if you develop a reaction at any time during your infusion, which may include dizziness, feeling faint, nauseated, face swelling, difficulty breathing, wheezing, or rash.
Croatian: osjećaj nesvjestice, mučninu, oticanje lica, otežano disanje, piskanje ili osip.
English: For safety reasons:
Croatian: Zbog sigurnosnih razloga:
English: 4 years
Croatian: 4 godine
English: Date of first authorisation: 17 July 2017
Croatian: Datum prvog odobrenja: 17. srpnja 2017
English: Q2W = every 2 weeks
Croatian: Q2W = svaka 2 tjedna
English: Grade 3 and 4 has been observed occasionally.
Croatian: Povremeno su opaženi stupanj 3 i 4.
English: Wash your hands thoroughly with soap and water.
Croatian: Dobro operite ruke sapunom i vodom.
English: DATE OF REVISION OF THE TEXT
Croatian: DATUM REVIZIJE TEKST
English: I. When you have finished, release your thumb.
Croatian: Nakon što ste završili, otpustite palac.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Croatian: Vaš će liječnik redovito nadzirati Vaše stanje kako bi provjerio ima li liječenje željeni učinak.
English: On a clean, well-lit work surface, place the:
Croatian: Na čistu i dobro osvijetljenu radnu površinu stavite:
English: After that, you will need to have an injection every two weeks.
Croatian: Nakon toga, morate primiti injekciju svaka dva tjedna.
English: AMAGINE-1 was conducted in 661 patients.
Croatian: AMAGINE-1 je proveden na 661 bolesniku.
English: • if you have tuberculosis (TB), have had a positive TB test, or have been in close contact with someone with TB.
Croatian: • ako imate tuberkulozu (TBC), imali ste pozitivni test na TBC ili ste bili u bliskom kontaktu s nekim s TBC-om.
English: • if you have an infection which your doctor thinks is important (for example, active tuberculosis).
Croatian: • ako imate infekciju koju Vaš liječnik smatra važnom (na primjer, aktivnu tuberkulozu).
English: • Your doctor will decide how much Kyntheum you need and for how long.
Croatian: • Vaš će liječnik odlučiti koliko lijeka Kyntheum trebate i koliko dugo.
English: Then, talk to your doctor about when you should inject the next dose.
Croatian: Zatim razgovarajte sa svojim liječnikom o tome kada trebate injicirati sljedeću dozu.
English: Let your skin dry.
Croatian: Ostavite kožu da se osuši.
English: Important: Needle is inside
Croatian: Važno: Igla je unutra
English: Cover with plaster if needed.
Croatian: Po potrebi prekrijte flasterom.
English: • If you want to use the same injection area each time, make sure it is not exactly the same spot that you used for a previous injection.
Croatian: • Ako svaki put želite upotrijebiti isto područje injiciranja, pripazite da to nije potpuno isto mjesto u koje ste prethodno injicirali lijek.
English: What Kyntheum is and what it is used for
Croatian: Što je Kyntheum i za što se koristi
English: • sharps disposal container (colour and appearance of container may differ depending on national requirements).
Croatian: • spremnik za odlaganje oštrih predmeta (boja i izgled spremnika može varirati ovisno o nacionalnim zahtjevima).
English: Suicidal ideation and behaviour
Croatian: Suicidalne misli i ponašanje
English: • Do not try to warm the syringe by using a heat source such as hot water or a microwave.
Croatian: • Nemojte pokušavati zagrijati štrcaljku uz pomoć izvora topline, kao što je topla voda ili mikrovalna pećnica.
English: Other populations
Croatian: Ostale populacije
English: • flu (influenza)
Croatian: • gripa (influenca)
English: If you stop treatment, symptoms of psoriasis may come back.
Croatian: Ako prekinete s liječenjem, simptomi psorijaze mogu se vratiti.
English: • if you are allergic to brodalumab or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na brodalumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The safety and efficacy of Kyntheum in children and adolescents below the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Kyntheum u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
English: Laboratoires LEO 39 route de Chartres 28500 Vernouillet France
Croatian: Laboratoires LEO 39 route de Chartres 28500 Vernouillet Francuska
English: F. Pinch your skin to create a firm surface
Croatian: F. Stisnite kožu da biste stvorili čvrstu površinu
English: • if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
Croatian: • ako primate bilo koje drugo liječenje za psorijazu, kao što je neki drugi imunosupresiv ili fototerapija ultraljubičastim (UV) svjetlom.
English: Not to be sold separately.
Croatian: Nije za pojedinačnu prodaju.
English: • Kyntheum is for long-term treatment.
Croatian: • Kyntheum je namijenjen za dugoročno liječenje.
English: Kyntheum has not been tested in pregnant women and it is not known if this medicine can harm your unborn baby.
Croatian: Kyntheum nije ispitan na trudnicama i nije poznato može li ovaj lijek naštetiti Vašem nerođenom djetetu.
English: • if you have an infection or have any signs of infection listed in Section 4 “Possible Side Effects”
Croatian: • ako imate neku infekciju ili bilo kakve znakove infekcije navedene u dijelu 4 "Moguće nuspojave"
English: Infections Kyntheum may increase the risk of infections.
Croatian: Kyntheum može povećati rizik infekcija.
English: Your doctor, pharmacist or nurse will tell you how often to inject the medicine.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra reći će Vam koliko često trebate injicirati lijek.
English: Step 3: Injecting
Croatian: 3. korak: Injicirajte
English: Tell your doctor if you think your signs and symptoms of psoriasis are not improving after using Kyntheum.
Croatian: Obavijestite svog liječnika ako smatrate da se vaši znaci i simptomi psorijaze ne poboljšavaju nakon uzimanja lijeka Kyntheum.
English: They are part of the syringe.
Croatian: Oni su dio štrcaljke.
English: • Do not put the syringe back in the refrigerator once it has reached room temperature.
Croatian: • Nemojte vraćati štrcaljku u hladnjak nakon što je dosegla sobnu temperaturu.
English: However, Kyntheum should not be given to patients with active tuberculosis.
Croatian: No Kyntheum se ne smije davati bolesnicima s aktivnom tuberkulozom.
English: Contents of the pack and other information What Kyntheum contains
Croatian: Sadržaj pakiranja i druge informacije Što Kyntheum sadrži
English: Component of a multipack.
Croatian: Sastavni dio višestrukog pakiranja.
English: Pinch the skin firmly between your thumb and fingers, creating an area about 5 centimetres wide.
Croatian: Čvrsto stisnite kožu između palca i prstiju tako da dobijete površinu širine približno 5 centimetara.
English: sPGA 0 or 1 Week 12 sPGA 0 or 1 Week 52
Croatian: sPGA 0 ili 1 u 12. tjednu 1 sPGA 0 ili 1 u 52. tjednu 0
English: • if you have been told you have tuberculosis.
Croatian: • ako ste saznali da imate tuberkulozu.
English: Patients enrolled were candidates for systemic therapy, including phototherapy, biologic and nonbiologic systemic therapies.
Croatian: Uključeni bolesnici bili su kandidati za sistemsku terapiju, uključujući fototerapiju, biološke i nebiološke sistemske terapije.
English: You should not be given certain types of vaccines (called ‘live vaccines') while being treated with Kyntheum
Croatian: Ne biste smjeli primiti određene vrste cjepiva (koja se zovu "živa cjepiva") dok se liječite lijekom Kyntheum
English: Immediately tell your doctor or seek medical help if you get any signs of a serious infection.
Croatian: Odmah obavijestite svog liječnika ili zatražite medicinsku pomoć ako se pojave bilo kakvi znakovi ozbiljne infekcije.
English: Table 2: Overview of the main efficacy results AMAGINE-1
Croatian: Tablica 2: Pregled glavnih rezultata djelotvornosti AMAGINE-1
English: Together you will consider the benefit of breast-feeding to the baby and the benefit of Kyntheum to you.
Croatian: Zajedno ćete razmotriti prednosti dojenja za bebu i prednosti lijeka Kyntheum za vas.
English: Put the box with any unused syringes back in the refrigerator.
Croatian: Vratite kutiju s neupotrijebljenim štrcaljkama u hladnjak.
English: • if you have used Kyntheum during the last three months of your pregnancy, you should talk to your doctor before vaccinating your baby
Croatian: • ako ste uzimali Kyntheum tijekom posljednja tri mjeseca trudnoće razgovarajte s liječnikom prije cijepljenja svog djeteta
English: • low white blood cell count
Croatian: • nizak broj bijelih krvnih stanica
English: If you have forgotten to inject a dose of Kyntheum, inject the next dose as soon as you can after the missed dose.
Croatian: Ako ste zaboravili injicirati dozu lijeka Kyntheum, injicirajte sljedeću dozu što je prije moguće nakon propuštene doze.
English: Exposure-response analysis indicates that higher brodalumab concentrations are related to better PASI and sPGA response.
Croatian: Analiza izloženosti-odgovora pokazuje da su više koncentracije brodalumaba povezane s boljim PASI i sPGA odgovorom.
English: What Kyntheum looks like and contents of the pack
Croatian: Kako Kyntheum izgleda i sadržaj pakiranja
English: Brodalumab belongs to a group of medicines called interleukin (IL) inhibitors.
Croatian: Brodalumab pripada skupini lijekova koji se zovu inhibitori interleukina (IL).
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC12
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC12
English: Possible serious infections (may affect up to 1 in 100 people), the signs may include:
Croatian: Moguće ozbiljne infekcije (mogu zahvatiti do 1 osobe na 100 ljudi), znakovi mogu uključivati sljedeće:
English: If patients develop active Crohn's disease, treatment should be discontinued permanently.
Croatian: Ako bolesnici razviju aktivnu Crohnovu bolest, liječenje je potrebno trajno prekinuti.
English: You should not stop using Kyntheum without speaking to your doctor first.
Croatian: Ne smijete prestati primjenjivati Kyntheum bez prethodnog razgovora sa svojim liječnikom.
English: Step 4: Finishing up J. Throw away the used syringe
Croatian: 4. korak: Završite J. Bacite upotrijebljenu štrcaljku
English: Grab here
Croatian: Primite ovdje
English: Tinea infections (including tinea pedis, tinea versicolor, tinea cruris)
Croatian: Često gripa tinea infekcije (uključujući tinea pedis, tinea versicolor, tinea cruris)
English: If you use more of this medicine than prescribed or take the dose sooner than required, tell your doctor.
Croatian: Ako primijenite više ovog lijeka nego što je propisano ili uzmete dozu ranije nego što je potrebno,
English: Of these patients, none had neutralising antibodies.
Croatian: Niti jedan od tih bolesnika nije imao neutralizirajuća protutijela.
English: Kyntheum is not recommended for children and adolescents (below 18 years of age) because it has not been studied in this age group.
Croatian: Ne preporučuje se primjena lijeka Kyntheum u djece i adolescenata (do 18 godina) jer nije provedeno ispitivanje u toj dobnoj skupini.
English: PSI responder: total score ≤8 with no item scores >1; SD: standard deviation.
Croatian: PSI ispitanik: ukupan rezultat ≤8 pri čemu nijedan rezultat nije bio >1; SD: standardna devijacija.
English: Other medicines and Kyntheum
Croatian: Drugi lijekovi i Kyntheum
English: • Keep in the original carton to protect from light or physical damage.
Croatian: • Čuvati u originalnom pakiranju radi zaštite od svjetlosti ili fizičkog oštećenja.
English: Guide to parts
Croatian: Vodič kroz dijelove
English: The recommended dose is 210 mg (one injection).
Croatian: Preporučena doza je 210 mg (jedna injekcija).
English: • After the first dose you will need to have a weekly injection at Week 1 (one week after the first dose) and Week 2 (two weeks after the first dose).
Croatian: • Nakon prve doze morat ćete primati tjednu injekciju u 1. tjednu (jedan tjedan nakon prve doze)
English: Population pharmacokinetic modelling indicated that exposure decreased as body weight increased.
Croatian: Populacijsko farmakokinetičko modeliranje pokazalo je da se izloženost smanjuje kako se tjelesna težina povećava.
English: • tinea (fungal) skin infections (including on feet and groin)
Croatian: • tinea (gljivične) infekcije kože (uključujući na stopalima i preponama)
English: Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose.
Croatian: Važno: Ako se pri uklanjanju štrcaljke čini da u tijelu štrcaljke ima ostataka lijeka, to znači da niste primili cijelu dozu.
English: Important: Keep the skin pinched until after you have injected.
Croatian: Važno: Držite kožu stisnutu dok ne završite s injiciranjem.
English: Quality of life/patient reported outcomes
Croatian: Kvaliteta života/ishodi koje prijavljuju bolesnici