FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare: Lupus-like syndrome
Croatian: Rijetko: sindrom sličan lupusu Poremećaji bubrega i mokraćnog sustava
English: 0.45 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen.
Croatian: 0,45 ml otopine u napunjenoj štrcaljki (staklo tipa 1) s pričvršćenom iglom (od nehrđajućeg čelika) i pokrovom za iglu (od gume koja sadrži lateks) u napunjenoj brizgalici.
English: Orange Priming Band
Croatian: Narančasta traka za provjeru protoka
English: Signs and symptoms Key results for the 50 mg dose at weeks 14 and 24 are shown in Table 6 and described below.
Croatian: Ključni rezultati za dozu od 50 mg u 14. i 24. tjednu prikazani su u tablici 6 i opisani u nastavku.
English: Simponi 100 mg solution for injection in pre-filled syringe Each 1 mL pre-filled syringe contains 100 mg of golimumab*.
Croatian: Simponi 100 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka od 1 ml sadrži 100 mg golimumaba*.
English: Simponi has minor influence on your ability to ride bicycles, drive and use tools or machines.
Croatian: Simponi malo utječe na sposobnost vožnje bicikla i upravljanja vozilima, alatima ili strojevima.
English: SC
Croatian: ASDAS-C
English: There have been reports of tuberculosis in patients receiving golimumab.
Croatian: U bolesnika liječenih golimumabom prijavljeni su slučajevi tuberkuloze.
English: Solution for injection in pre-filled syringe 1 pre-filled syringe
Croatian: Otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka
English: The efficacy of Simponi through week 54 was assessed in this study.
Croatian: U tom je ispitivanju ocijenjena djelotvornost lijeka Simponi do 54. tjedna liječenja.
English: Table 5 Radiographic mean (SD) changes from baseline in total vdH-S score at week 52 in the overall population of GO-BEFORE Placebo + MTX Simponi 50 mg + MTX
Croatian: Tablica 5 Srednja vrijednost (SD) radiološki vidljivih promjena u odnosu na početno stanje ukupnog broja vdH-S bodova u 52. tjednu u ukupnoj populaciji u ispitivanju GO-BEFORE
English: Overview
Croatian: Pregled
English: Responses were observed at the first assessment (week 4) after the initial Simponi administration.
Croatian: Odgovori na liječenje primijećeni su već pri prvoj kontroli (u 4. tjednu) nakon početne primjene lijeka Simponi.
English: Solution for injection in pre-filled pen (VarioJect) 1 pre-filled pen
Croatian: Otopina za injekciju u napunjenoj brizgalici (VarioJect) 1 napunjena brizgalica
English: Signs and symptoms Key results for the 50 mg dose at weeks 14 and 24 are shown in table 4 and described below.
Croatian: Ključni rezultati za dozu od 50 mg u 14. i 24. tjednu prikazani su u tablici 4 i opisani u nastavku.
English: • In patients weighing less than 80 kg, 50 mg (the 50 mg pre-filled pen or pre-filled syringe must be used to administer this dose) 4 weeks after your last treatment, then every 4 weeks thereafter.
Croatian: • U bolesnika tjelesne težine manje od 80 kg primjenjuje se doza od 50 mg (za primjenu ove doze mora se koristiti napunjena brizgalica od 50 mg ili napunjena štrcaljka od 50 mg ) 4 tjedna nakon posljednje terapije, a zatim svaka 4 tjedna nakon toga.
English: Adult psoriatic arthritis
Croatian: Psorijatični artritis u odraslih
English: Simponi 50 mg solution for injection in pre-filled syringe One 0.5 mL pre-filled syringe contains 50 mg of golimumab*.
Croatian: Simponi 50 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka od 0,5 ml sadrži 50 mg golimumaba*.
English: Check the number of pre-filled pens Check the pre-filled pens to make sure
Croatian: Provjerite napunjene brizgalice kako biste bili sigurni
English: Malignancies
Croatian: • mučnina
English: Patients were randomly assigned to placebo, Simponi 50 mg, or Simponi 100 mg.
Croatian: Bolesnici su randomizirani u skupine koje su primale placebo, Simponi 50 mg ili Simponi 100 mg.
English: Simponi is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens.
Croatian: Simponi je dostupan u pakiranju koje sadrži 1 napunjenu brizgalicu i višestrukom pakiranju koje sadrži 3 napunjene brizgalice (3 pakiranja s 1 napunjenom brizgalicom).
English: Do not fan or blow on the clean area.
Croatian: Nemojte sušiti očišćeno mjesto mahanjem ili puhanjem iz usta.
English: golimumab 100 mg-treated subjects with an incidence (95% CI) per 100 subject-years of follow-up of 0.36 (0.26, 0.49) for combined golimumab and 0.87 (0.28, 2.04) for placebo.
Croatian: 100 ispitanik-godina praćenja od 0,48 (0,36; 0,62) za obje doze golimumaba, a 0,87 (0,28; 2,04) događaja za placebo (vidjeti dio 4.4).
English: Do not inject if the liquid is the wrong colour, cloudy or has large particles.
Croatian: Nemojte injicirati lijek ako je tekućina promijenila boju, ako je zamućena ili ako sadrži veće čestice.
English: Do not use the pre-filled syringe if the liquid is the wrong colour, cloudy, or contains larger particles.
Croatian: Ne koristite napunjenu štrcaljku ako je otopina neodgovarajuće boje, ako je zamućena ili sadrži strane čestice.
English: Symptoms include persistent rash, fever, joint pain and tiredness.
Croatian: Oni uključuju uporan osip, vrućicu, bol u zglobovima i umor.
English: Simponi has minor influence on the ability to drive and use machines.
Croatian: Simponi malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Common: Dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders (such as gastritis and colitis), stomatitis Uncommon: Constipation, gastro-oesophageal reflux disease
Croatian: Često: astma i vezani simptomi (npr. piskanje u plućima i hiperaktivnost bronha) Manje često: intersticijska bolest pluća Poremećaji probavnog sustava Često: dispepsija, gastrointestinalna i abdominalna bol, mučnina, gastrointestinalni upalni poremećaji (npr. gastritis i kolitis), stomatitis Manje često: konstipacija, gastroezofagealna refluksna bolest
English: • Skin blisters
Croatian: • žučni kamenci
English: Do not lift the pre-filled pen away from your skin.
Croatian: Još ne smijete podići napunjenu brizgalicu s kože.
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.
Croatian: Simponi 45 mg/0,45 ml otopina za injekciju u napunjenoj brizgalici.
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen golimumab
Croatian: Simponi 45 mg/0,45 ml otopina za injekciju u napunjenoj brizgalici golimumab
English: A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Croatian: U djece i adolescenata koji se liječe TNF-blokatorima ne može se isključiti rizik od razvoja zloćudnih bolesti.
English: In the controlled and uncontrolled periods of pivotal trials with a median follow-up of up to 3 years, non-melanoma skin cancer was diagnosed in 5 placebo-treated, 10 golimumab 50 mg-treated and 31 golimumab 100 mg-treated subjects with an incidence (95% CI) per 100 subject-years of follow-up of 0.36 (0.26, 0.49) for combined golimumab and 0.87 (0.28, 2.04) for placebo.
Croatian: U kontroliranim i nekontroliranim razdobljima pivotalnih ispitivanja s medijanom praćenja do 3 godine nemelanomski rak kože dijagnosticiran je u 5 ispitanika koji su primali placebo, 10 ispitanika liječenih golimumabom u dozi od 50 mg te 31 ispitanika liječenog golimumabom u dozi od 100 mg, s incidencijom (95%, CI) na 100 ispitanik-godina praćenja od 0,36 (0,26; 0,49) događaja za obje doze golimumaba, a 0,87 (0,28; 2,04) događaja za placebo.
English: • Chest discomfort
Croatian: • otežano zacjeljivanje
English: Polyarticular juvenile idiopathic arthritis
Croatian: Poliartikularni juvenilini idiopatski artritis
English: Table 3 Radiographic mean (SD) changes from baseline in total vdH-S score at week 52 in the overall population of GO-BEFORE Placebo + MTX Simponi 50 mg + MTX
Croatian: Tablica 3 Srednja vrijednost (SD) radiološki vidljivih promjena u odnosu na početno stanje ukupnog broja vdH-S bodova u 52. tjednu u ukupnoj populaciji u ispitivanju GO-BEFORE
English: Simponi 100 mg solution for injection in pre-filled syringe.
Croatian: Simponi 100 mg otopina za injekciju u napunjenoj štrcaljki.
English: • Tell your surgeon or dentist performing the procedure that you are having treatment with
Croatian: • Obavijestite svog kirurga ili stomatologa da uzimate Simponi i pokažite im svoju Karticu s podsjetnikom za bolesnika.
English: One 0.5 mL pre-filled syringe contains 50 mg of golimumab.
Croatian: Jedna napunjena štrcaljka od 0,5 ml sadrži 50 mg golimumaba.
English: Simponi 50 mg solution for injection in pre-filled pen One 0.5 mL pre-filled pen contains 50 mg of golimumab*.
Croatian: Simponi 50 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica od 0,5 ml sadrži 50 mg golimumaba*.
English: There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anaemia, and thrombocytopenia in patients receiving TNF-blockers, including golimumab.
Croatian: U bolesnika liječenih TNF-blokatorima, uključujući golimumab, prijavljene su pancitopenija, leukopenija, neutropenija, agranulocitoza, aplastična anemija i trombocitopenija.
English: HCP.
Croatian: NP
English: Uncommon: Neoplasms (such as skin cancer, squamous cell carcinoma and melanocytic naevus) Rare: Lymphoma, leukaemia, melanoma, Merkel cell carcinoma Not known: Hepatosplenic T-cell lymphoma* Blood and lymphatic system disorders
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine Manje često: novotvorine (npr. rak kože, planocelularni karcinom i melanocitni nevus) Rijetko: limfomi, leukemija, melanom, karcinom Merkelovih stanica Nepoznato: hepatosplenički limfom T-stanica* Poremećaji krvi i limfnog sustava Često: leukopenija (uključujući neutropeniju), anemija Manje često: trombocitopenija, pancitopenija Rijetko: aplastična anemija, agranulocitoza Poremećaji imunološkog sustava Često: alergijske reakcije (bronhospazam, preosjetljivost, urtikarija), pozitivna autoantitijela Rijetko: ozbiljne sistemske reakcije preosjetljivosti (uključujući anafilaktičku reakciju), vaskulitis (sistemski), sarkoidoza
English: In the controlled and uncontrolled portions of these trials with a median follow-up of up to 3 years, a greater incidence of lymphoma was observed in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg. Lymphoma was diagnosed in 11 subjects (1 in the golimumab 50 mg treatment groups and 10 in the golimumab 100 mg treatment groups) with an incidence (95% CI) per 100 subject-years of follow-up of 0.03 (0.00, 0.15) and 0.13 (0.06, 0.24) events for golimumab 50 mg and 100 mg respectively and 0.00 (0.00, 0.57) events for the placebo.
Croatian: Limfom je dijagnosticiran u 11 ispitanika (1 iz skupine liječene golimumabom u dozi od 50 mg i 10 u skupini liječenoj golimumabom u dozi od 100 mg) s incidencijom (95% CI) na 100 ispitanik-godina praćenja od 0,03 (0,00; 0,15) događaja te 0,13 (0,06; 0,24) za golimumab u dozi od 50 mg i 100 mg, a 0,00 (0,00; 0,57) događaja za placebo.
English: Simponi has minor influence on your ability to drive and use tools or machines.
Croatian: Simponi malo utječe na sposobnost vožnje i upravljanja alatima ili strojevima.
English: Simponi 50 mg solution for injection in pre-filled syringe.
Croatian: Simponi 50 mg otopina za injekciju u napunjenoj štrcaljki.
English: Tap the pre-filled pen gently with your finger near the viewing window.
Croatian: Prstom nježno lupkajte po napunjenoj brizgalici u blizini prozorčića kako bi se mjehurići zraka podigli na vrh.
English: Metabolism and nutrition disorders Uncommon: Blood glucose increased, lipids increased
Croatian: Manje često: poremećaj štitnjače (npr. hipotireoza, hipertireoza i guša) Poremećaji metabolizma i prehrane Manje često: povišena razina glukoze u krvi, povišena razina lipida Psihijatrijski poremećaji
English: Statistically significant improvements in signs and symptoms of severe active nr-Axial SpA were demonstrated in patients treated with Simponi 50 mg compared to placebo at week 16 (Table 6).
Croatian: U bolesnika liječenih lijekom Simponi u dozi od 50 mg pokazalo se statistički značajno poboljšanje u znakovima i simptomima teškog aktivnog aksijalnog spondiloartritisa bez radiološkog dokaza u usporedbi s placebom u 16. tjednu (tablica 6).
English: Solution for injection in pre-filled pen (Smartject) 1 pre-filled pen
Croatian: Otopina za injekciju u napunjenoj brizgalici (SmartJect) 1 napunjena brizgalica
English: Simponi 50 mg administered once a month, on the same date each month, for children with a body weight of at least 40 kg. A 45 mg/0.45 mL pre-filled pen is available for administration to children with polyarticular juvenile idiopathic arthritis weighing less than 40 kg.
Croatian: Primjenjuje se 50 mg lijeka Simponi jedanput na mjesec, istoga dana u mjesecu, u djece s tjelesnom težinom od najmanje 40 kg.
English: • Do not shake the pre-filled syringe at any time.
Croatian: • Nikada ne tresite napunjenu brizgalicu.
English: • Blood clots
Croatian: • krvni ugrušci
English: NA
Croatian: o
English: One 0.45 mL pre-filled pen contains 45 mg of golimumab.
Croatian: Jedna napunjena brizgalica od 0,45 ml sadrži 45 mg golimumaba.
English: • You may get infections more easily while using Simponi.
Croatian: • Tijekom liječenja lijekom Simponi možete postati osjetljiviji na infekcije.
English: • Bladder disorders
Croatian: • poremećaji štitnjače
English: Clean injection site
Croatian: Očistite mjesto injekcije
English: Do not use the pre-filled pen if it is dropped without the cap on.
Croatian: Nemojte upotrijebiti napunjenu brizgalicu ako Vam je pala nakon što ste skinuli poklopac.
English: EU/1/09/546/007 1 pre-filled syringe EU/1/09/546/008 3 pre-filled syringes
Croatian: EU/1/09/546/007 1 napunjena štrcaljka EU/1/09/546/008 3 napunjene štrcaljke
English: Among patients remaining in the study and treated with Simponi, similar rates of patients showed no progression from baseline from week 104 through week 256.
Croatian: Među bolesnicima koji su ostali u ispitivanju i bili liječeni lijekom Simponi, udio bolesnika u kojih nije došlo do progresije u odnosu na početno stanje bio je sličan od 104. do 256. tjedna.
English: However, you and your doctor may decide that you may inject Simponi yourself.
Croatian: Vaš liječnik se možete dogovoriti da si sljedeće doze lijeka Simponi dajete sami.
English: One 1 mL pre-filled syringe contains 100 mg of golimumab.
Croatian: Jedna napunjena brizgalica od 1 ml sadrži 100 mg golimumaba.
English: • Keep the pre-filled syringe in the outer carton in order to protect it from light.
Croatian: • Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: responses were maintained through week 104.
Croatian: 70 ih je i dalje uzimalo tu terapiju u 104. tjednu.
English: What Simponi looks like and contents of the pack Simponi is supplied as solution for injection in a single-use pre-filled pen, VarioJect.
Croatian: Simponi dolazi na tržište u obliku otopine za injekciju u napunjenoj brizgalici za jednokratnu uporabu koja se zove VarioJect.
English: EU/1/09/546/005 1 pre-filled pen EU/1/09/546/006 3 pre-filled pens
Croatian: EU/1/09/546/005 1 napunjena brizgalica EU/1/09/546/006 3 napunjene brizgalice
English: Simponi 100 mg solution for injection in pre-filled syringe golimumab
Croatian: Simponi 100 mg otopina za injekciju u napunjenoj brizgalici golimumab
English: Simponi 100 mg solution for injection in pre-filled syringe 1 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex).
Croatian: Simponi 100 mg otopina za injekciju u napunjenoj štrcaljki 1 ml otopine u napunjenoj štrcaljki (staklo tipa 1) s pričvršćenom iglom (od nehrđajućeg čelika) i pokrovom za iglu (od gume koja sadrži lateks).
English: The efficacy of Simponi through week 6 was assessed in this study.
Croatian: U tom je ispitivanju ocijenjena djelotvornost lijeka Simponi do 6 tjedana liječenja.
English: Simponi 100 mg solution for injection in pre-filled pen Each 1 mL pre-filled pen contains 100 mg of golimumab*.
Croatian: Simponi 100 mg otopina za injekciju u napunjenoj brizgalici Jedna napunjena brizgalica od 1 ml sadrži 100 mg golimumaba*.
English: Simponi 50 mg solution for injection in pre-filled syringe golimumab
Croatian: Simponi 50 mg otopina za injekciju u napunjenoj brizgalici golimumab
English: Sorbitol intolerance This medicine contains 20.5 mg sorbitol (E420) in each pre-filled syringe.
Croatian: Ovaj lijek sadrži 20,5 mg sorbitola (E420) u jednoj napunjenoj štrcaljki.
English: Simponi 50 mg solution for injection in pre-filled syringe 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex).
Croatian: Simponi 50 mg otopina za injekciju u napunjenoj štrcaljki 0,5 ml otopine u napunjenoj štrcaljki (staklo tipa 1) s pričvršćenom iglom (od nehrđajućeg čelika) i pokrovom za iglu (od gume koja sadrži lateks).
English: Sorbitol intolerance This medicine contains 41 mg sorbitol (E420) in each pre-filled syringe.
Croatian: Ovaj lijek sadrži 41 mg sorbitola (E420) u jednoj napunjenoj štrcaljki.
English: One 0.5 mL pre-filled pen contains 50 mg of golimumab.
Croatian: Jedna napunjena brizgalica od 0,5 ml sadrži 50 mg golimumaba.
English: Table 8 Improvements from baseline in ACR Ped components at week 16 Median percent improvement Simponi 30 mg/m b = 173
Croatian: Tablica 8 Poboljšanje komponenata odgovora ACR Ped od početka ispitivanja do 16. tjedna Medijan postotka poboljšanja
English: Simponi 50 mg solution for injection in pre-filled pen 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen.
Croatian: Simponi 50 mg otopina za injekciju u napunjenoj brizgalici 0,5 ml otopine u napunjenoj štrcaljki (staklo tipa 1) s pričvršćenom iglom (od nehrđajućeg čelika) i pokrovom za iglu (od gume koja sadrži lateks) u napunjenoj brizgalici.
English: Each pre-filled pen can deliver 0.1 mL to 0.45 mL in increments of 0.05 mL.
Croatian: Jednom napunjenom brizgalicom može se primijeniti 0,1 ml do 0,45 ml otopine u koracima od 0,05 ml. Pakiranje s 1 napunjenom brizgalicom.
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 responses were maintained through week 104.
Croatian: Odgovor DAS28 kod bolesnika koji su nastavili liječenje lijekom Simponi te koje im je randomizacijom bilo dodijeljeno na početku ispitivanja održao se do 104. tjedna.
English: Do not touch, fan, or blow on the injection site after you have cleaned it.
Croatian: Očišćeno mjesto injekcije nemojte dirati niti sušiti vrućim zrakom ili puhanjem.
English: Sorbitol intolerance This medicine contains 20.5 mg sorbitol (E420) in each pre-filled pen.
Croatian: Ovaj lijek sadrži 20,5 mg sorbitola (E420) u jednoj napunjenoj brizgalici.
English: • In patients weighing less than 80 kg, 50 mg (the contents of 1 pre-filled syringe) 4 weeks after your last treatment, then every 4 weeks thereafter.
Croatian: • U bolesnika tjelesne težine manje od 80 kg primjenjuje se doza od 50 mg (sadržaj 1 napunjene brizgalice) 4 tjedna nakon posljednje terapije, a zatim svaka 4 tjedna nakon toga.
English: EU/1/09/546/002 (3 packs, each containing 1 pre-filled pen)
Croatian: EU/1/09/546/002 (3 pakiranja, svako sadrži 1 napunjenu brizgalicu)
English: EU/1/09/546/006 (3 packs, each containing 1 pre-filled pen)
Croatian: EU/1/09/546/006 (3 pakiranja, svako sadrži 1 napunjenu brizgalicu)
English: EU/1/09/546/001 1 pre-filled pen EU/1/09/546/002 3 pre-filled pens
Croatian: EU/1/09/546/001 1 napunjena brizgalica EU/1/09/546/002 3 napunjene brizgalice
English: There were no patients age 45 and over in the non-radiographic axial spondyloarthritis (nr-Axial SpA) study.
Croatian: U ispitivanju aksijalnog spondiloartritisa bez radiološkog dokaza (engl. non-radiographic axial spondyloarthritis, nr-Axial SpA) nije bilo bolesnika u dobi od 45 godina ili starijih.
English: • Breast disorders
Croatian: • poremećaji dojki
English: Your doctor may decide to prescribe 100 mg (the contents of 2 pre-filled syringes), depending on how well Simponi works for you.
Croatian: Liječnik će Vam možda odlučiti propisati dozu od 100 mg (sadržaj 2 napunjene brizgalice), ovisno o tome koliko dobro Simponi djeluje kod Vas.
English: Further treatment with golimumab must not be given if a patient develops a serious infection or sepsis (see section 4.3).
Croatian: Ako se u bolesnika razvije ozbiljna infekcija ili sepsa, ne smije se nastaviti liječenje golimumabom (vidjeti dio 4.3).
English: A starting dose of 200 mg (the contents of 2 pre-filled syringes) followed by 100 mg (the contents of 1 pre-filled syringe) 2 weeks later.
Croatian: Početna doza od 200 mg (sadržaj 2 napunjene brizgalice), a zatim doza od 100 mg (sadržaj 1 napunjene brizgalice) 2 tjedna nakon toga.
English: • Do not use the pre-filled pen if it is dropped without the cap in place.
Croatian: • Ne koristite napunjenu brizgalicu ako Vam je pala nakon što ste skinuli poklopac.
English: Keep the pre-filled syringe in the outer carton in order to protect from light
Croatian: Čuvati napunjenu štrcaljku u vanjskom pakiranju radi zaštite od svjetlosti.
English: Sorbitol intolerance This medicine contains 41 mg sorbitol (E420) in each pre-filled pen.
Croatian: Ovaj lijek sadrži 41 mg sorbitola (E420) u jednoj napunjenoj brizgalici.
English: A starting dose of 200 mg (the contents of 4 pre-filled syringes) followed by 100 mg (the contents of 2 pre-filled syringes) 2 weeks later.
Croatian: Početna doza od 200 mg (sadržaj 4 napunjene brizgalice), a zatim doza od 100 mg (sadržaj 2 napunjene brizgalice) 2 tjedna nakon toga.
English: EU/1/09/546/008 (3 packs, each containing 1 pre-filled syringe)
Croatian: EU/1/09/546/008 (3 pakiranja, svako sadrži 1 napunjenu štrcaljku)
English: Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Croatian: Kad se spremnik napuni, trebate ga zbrinuti sukladno uputama koje ste dobili od liječnika ili medicinske sestre.
English: Simponi 100 mg solution for injection in pre-filled pen 1 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen.
Croatian: Simponi 100 mg otopina za injekciju u napunjenoj brizgalici 1 ml otopine u napunjenoj štrcaljki (staklo tipa 1) s pričvršćenom iglom (od nehrđajućeg čelika) i pokrovom za iglu (od gume koja sadrži lateks) u napunjenoj brizgalici.
English: Simponi 50 mg solution for injection in pre-filled pen.
Croatian: Simponi 50 mg otopina za injekciju u napunjenoj brizgalici.
English: • Keep the pre-filled pen in the outer carton in order to protect it from light.
Croatian: • Napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: EU/1/09/546/003 1 pre-filled syringe EU/1/09/546/004 3 pre-filled syringes
Croatian: EU/1/09/546/003 1 napunjena štrcaljka EU/1/09/546/004 3 napunjene štrcaljke
English: This trend was not observed in the PsA population.
Croatian: Taj trend nije opažen u bolesnika s psorijatičnim artritisom.
English: Simponi 50 mg solution for injection golimumab
Croatian: Simponi 50 mg otopina za injekciju golimumab s.c.
English: Simponi 100 mg solution for injection golimumab
Croatian: Simponi 100 mg otopina za injekcija golimumab s.c.
English: A drug-tolerant EIA method was used in the pJIA study for the detection of antibodies to golimumab.
Croatian: Za otkrivanje protutijela na golimumab u ispitivanju provedenom u bolesnika s pJIA koristila se EIA metoda otporna na lijek.
English: • In patients weighing 80 kg or more, 100 mg (the contents of 1 pre-filled syringe) 4 weeks after your last treatment, then every 4 weeks thereafter.
Croatian: • U bolesnika tjelesne težine 80 kg ili veće primjenjuje se doza od 100 mg (sadržaj 1 napunjene brizgalice) 4 tjedna nakon posljednjeg liječenja, a zatim svaka 4 tjedna nakon toga.
English: Non-radiographic axial spondyloarthritis
Croatian: Aksijalni spondiloartritis bez radiološkog dokaza