FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 10 provides a summary of the comparison between the Hemlibra prophylaxis arm (Arm A) and the no prophylaxis arm (Arm B) on the EQ-5D-5L index utility scale and visual analog scale after 24 weeks of treatment adjusting for baseline.
Croatian: (skupina A) i skupine koja nije primala profilaksu (skupina B) s obzirom na indeks korisnosti i rezultat na vizualnoj analognoj ljestvici (engl. visual analogue scale, VAS) prema upitniku EQ-5D-5L nakon
English: All bleeds: bleeds treated and not treated with bypassing agents.
Croatian: Sva krvarenja: liječena krvarenja i ona koja nisu liječena faktorom VIII.
English: Step C. Attach a new transfer needle to syringe
Croatian: 2. korak: Pričvrstite iglu za prijenos na štrcaljku
English: ● Slowly pull back the plunger to fill the syringe barrel more than the amount of medicine needed for your prescribed dose.
Croatian: Polako povlačite klip da biste u tijelo štrcaljke uvukli količinu lijeka koja je veća od one potrebne za primjenu propisane doze.
English: ABR= Annualised Bleed Rate; CI= confidence interval; RR= rate ratio; IQR=interquartile range, 25th percentile to 75
Croatian: CI (confidence interval) = interval pouzdanosti; RR (rate ratio) = omjer stope; IKR= interkvartilni raspon, od 25. percentila do 75. percentila
English: ● A syringe, a transfer needle (or vial adapter), and an injection needle are needed to draw up the Hemlibra solution from the vial into the syringe and to inject it under the skin.
Croatian: Za izvlačenje otopine lijeka Hemlibra iz bočice u štrcaljku i injiciranje pod kožu potrebni su štrcaljka, igla za prijenos (ili nastavak za bočicu) i igla za injiciranje.
English: Throw away any used caps, vial(s) and syringes and needles.
Croatian: Bacite sve upotrijebljene zatvarače, bočice, štrcaljke i igle.
English: Colourless to slightly yellow solution.
Croatian: Bezbojna do blijedožuta otopina.
English: Step B. Remove transfer needle
Croatian: 9. korak: Skinite iglu za prijenos
English: ● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected every two weeks.
Croatian: 150 mg/ml: 120 mg emicizumaba ÷ 150 mg/ml = 0,8 ml (volumen lijeka Hemlibra koncentracije 150 mg/ml koji treba injicirati svaka dva tjedna).
English: Use of Hemlibra in patients aged 65 and over with haemophilia A is supported by adult and adolescent studies HAVEN 1, HAVEN 3, and HAVEN 4.
Croatian: Primjenu lijeka Hemlibra u bolesnika s hemofilijom A u dobi od 65 i više godina podupiru ispitivanja provedena u odraslih i adolescentnih bolesnika HAVEN 1, HAVEN 3 i HAVEN 4. Na temelju ograničenih podataka nema dokaza koji bi ukazivali na razliku u djelotvornosti ili sigurnosti lijeka u bolesnika u dobi od 65 ili više godina.
English: How to store Hemlibra
Croatian: Kako čuvati lijek Hemlibra
English: NAME OF THE MEDICINAL PRODUCT Hemlibra 150 mg/mL solution for injection emicizumab
Croatian: Hemlibra 150 mg/ml otopina za injekciju emicizumab
English: Step E. Inject air into vial
Croatian: 4. korak: Ubrizgajte zrak u bočicu
English: Laboratory tests affected and unaffected by emicizumab are shown in Table 1 below.
Croatian: Tablici 1 prikazani su laboratorijski testovi na koje emicizumab utječe i oni na koje ne utječe.
English: Table 6 HAVEN 1: Annualized Bleed Rate with Hemlibra prophylaxis arm versus no prophylaxis arm in patients ≥ 12 years of age with factor VIII inhibitors
Croatian: Tablica 6 HAVEN 1: Anualizirana stopa krvarenja u bolesnika u dobi od ≥ 12 godina s inhibitorima faktora VIII u skupini koja je primala profilaksu lijekom Hemlibra naspram skupine koja nije primala profilaksu
English: One patient resumed Hemlibra following resolution of TMA without recurrence.
Croatian: Jedan je bolesnik nakon povlačenja trombotskog događaja nastavio liječenje lijekom Hemlibra, bez ponovnog nastupa takvog događaja
English: Previous FVIII Prophylaxis (N = 48)
Croatian: Skupina D (NII): Prethodna profilaksa faktorom VIII (N = 48)
English: Index Utility Score Adjusted mean
Croatian: Prilagođena srednja vrijednost Razlika prilagođenih srednjih vrijednosti
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Croatian: Roche Registration GmbH Emil-Barell-Strasse 1
English: Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.
Croatian: Kriteriji: Prozirna polipropilenska ili polikarbonatna štrcaljka s Luer-Lock vrhom, graduirana po
English: ● Throw away the used vial/vial adapter into a sharps disposal container.
Croatian: Bacite iskorištenu bočicu/nastavak za bočicu u spremnik za odlaganje oštrih predmeta.
English: Treated bleeds: bleeds treated with bypassing agents.
Croatian: Liječena krvarenja: krvarenja liječena lijekovima koji zaobilaze akivnost faktora VIII.
English: ● With the syringe pointing upwards, slowly pull back the plunger to fill the syringe with more than the amount of medicine needed for your prescribed dose.
Croatian: Držite štrcaljku usmjerenu prema gore i polako povlačite klip dok ne napunite štrcaljku lijekom u količini koja je veća od propisane doze.
English: Adjust plunger to prescribed dose
Croatian: 11. korak: Pomaknite klip do propisane doze
English: ● To calculate the volume to be administered divide calculated dose 48 mg by 150 mg/mL: 48 mg of emicizumab ÷ 150 mg/mL = 0.32 mL of 150 mg/mL Hemlibra concentration to be injected.
Croatian: 150 mg/ml: 48 mg emicizumaba ÷ 150 mg/ml = 0,32 ml (volumen lijeka Hemlibra koncentracije 150 mg/ml koji treba injicirati).
English: Step 2.
Croatian: Korak D.
English: L-Arginine L-Histidine L-Aspartic acid Poloxamer 188
Croatian: L-aspartatna kiselina poloksamer 188 voda za injekcije
English: NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection emicizumab
Croatian: Hemlibra 30 mg/ml otopina za injekciju emicizumab
English: ● Do not touch the tip of vial adapter.
Croatian: ● Nemojte dodirivati vrh nastavka za bočicu.
English: Different Hemlibra concentrations (30 mg/mL and 150 mg/mL) should not be combined in the same syringe when making up the total volume to be administered.
Croatian: Hemlibra (30 mg/ml i 150 mg/ml) u istoj štrcaljki.
English: - the cap covering the stopper is missing.
Croatian: - ako lijek sadrži vidljive čestice - ako nedostaje zatvarač koji prekriva čep.
English: Different Hemlibra concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection when making up the total volume to be injected.
Croatian: Hemlibra (30 mg/ml i 150 mg/ml) u jednoj injekciji.
English: ● To calculate the volume to be administered divide calculated dose 180 mg by 150 mg/mL: 180 mg of emicizumab ÷ 150 mg/mL = 1.20 mL of 150 mg/mL Hemlibra concentration to be injected.
Croatian: 150 mg/ml: 180 mg emicizumaba ÷ 150 mg/ml = 1,20 ml (volumen lijeka Hemlibra koncentracije 150 mg/ml koji treba injicirati).
English: ● Push and twist the injection needle clockwise onto the syringe until it is fully attached.
Croatian: Nataknite iglu za injiciranje na štrcaljku i okrećite je u smjeru kazaljke na satu sve dok ne bude čvrsto pričvršćena.
English: Table 13 HAVEN 2: Change from baseline to week 25 in the Physical Health score of patients (< 12 years of age) following treatment with Hemlibra prophylaxis as reported by patients and caregivers
Croatian: < 12 godina) od početka ispitivanja do 25. tjedna nakon profilaktičkog liječenja lijekom Hemlibra, prema izjavama bolesnika i njegovatelja Haemo-QoL-SF
English: ● muscle aches
Croatian: ● Štrcaljka
English: ● Keep the transfer needle in the vial and turn the vial upside down.
Croatian: Držite iglu za prijenos u bočici i preokrenite bočicu.
English: Subcutaneous (under the skin) injection
Croatian: 12. korak: Supkutana (potkožna) injekcija
English: - Emicizumab increases the patient's coagulation potential and the dose and duration of treatment with bypassing agents may require adjustment depending on the location and extent of bleeding and on the patient's clinical conditions; - For all coagulation agents (aPCC, rFVIIa, FVIII, etc.), consideration should be given to verifying bleeds prior to repeated dosing; - Use of aPCC should be avoided unless no other treatment options/alternatives are available and aPCC dosing recommendations in case aPCC is the only option.
Croatian: Emicizumab povećava koagulacijski potencijal bolesnika pa će možda biti potrebno prilagoditi dozu i trajanje liječenja lijekovima koji zaobilaze akivnost faktora VIII, ovisno o lokaciji i opsegu krvarenja te o bolesnikovom kliničkom stanju.
English: ● Slowly pull back the plunger to fill the syringe with more than the amount of medicine needed for your prescribed dose.
Croatian: Polako povlačite klip da biste u štrcaljku uvukli količinu lijeka koja je veća od propisane doze.
English: Do not use the transfer needle to inject the medicine.
Croatian: Nemojte iglom za injiciranje izvlačiti lijek iz bočice.
English: ● Remove the transfer needle from the syringe by twisting anticlockwise and gently pulling.
Croatian: Skinite iglu za prijenos sa štrcaljke okrećući je u smjeru suprotnom od smjera kazaljke na satu i lagano je povucite.
English: ● Clean the top of the vial(s) stopper with an alcohol wipe.
Croatian: Očistite vrh čepa bočice/bočica maramicom natopljenom alkoholom.
English: Treated bleeds ABR (95% CI) % reduction (RR), p-value
Croatian: Medijan anualizirane stope krvarenja (IKR) % smanjenje (RR), p-vrijednost
English: th percentile
Croatian: Mjera ishoda
English: ● Cotton Ball
Croatian: Pamučna vata
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL.
Croatian: Jedna bočica od 0,4 ml sadrži 60 mg emicizumaba u koncentraciji od 150 mg/ml.
English: ● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected.
Croatian: 150 mg/ml: 120 mg emicizumaba ÷ 150 mg/ml = 0,8 ml (volumen lijeka Hemlibra koncentracije 150 mg/ml koji treba injicirati).
English: 1For important considerations regarding FVIII chromogenic activity assays, see section 4.4.
Croatian: 1Za važne parametre koje treba razmotriti kod kromogenih testova za određivanje aktivnosti FVIII
English: ● Push and twist the syringe clockwise on to the vial adapter until it is fully attached.
Croatian: ● Nataknite štrcaljku na nastavak za bočicu i okrećite je u smjeru kazaljke na satu dok ne bude potpuno pričvršćena.
English: Step 7.
Croatian: Korak C.
English: ● Throw away any used caps, vial(s), vial adapters, needles and syringes in a sharps or puncture-proof container.
Croatian: Bacite sve upotrijebljene zatvarače, bočice, nastavke za bočicu, igle i štrcaljke u spremnik za odlaganje oštrih predmeta ili neprobojni spremnik.
English: - leak-resistant.
Croatian: “klik”.
English: ● Remove the used vial adapter from the syringe by twisting anticlockwise and gently pulling.
Croatian: Skinite štrcaljku s iskorištenog nastavka za bočicu okrećući je u smjeru suprotnom od smjera kazaljke na satu i lagano je povucite.
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Croatian: Roche Pharma AG Emil-Barell-Strasse 1
English: When used together with a vial adapter, a low dead space plunger 1 mL syringe (transparent polypropylene or polycarbonate syringe with Luer lock tip, graduation 0.01 mL) must be used.
Croatian: „mrtvim prostorom“ (engl. dead space) (prozirna polipropilenska ili polikarbonatna štrcaljka s Luer-Lock vrhom, graduirana po 0,01 ml).
English: ABR= Annualised Bleed Rate; CI= confidence interval; RR= rate ratio; IQR=interquartile range, 25th percentile to 75th percentile
Croatian: CI = interval pouzdanosti; RR = omjer stope; IKR = interkvartilni raspon, od 25. percentila do 75. percentila
English: Tabulated list of adverse drug reactions
Croatian: Sažetak opisa svojstava lijeka
English: Musculoskeletal and connective tissue disorders
Croatian: Oštećenje bubrežne i jetrene funkcije
English: Recap transfer needle
Croatian: Igla za prijenos
English: When used together with a vial adapter, a low dead space plunger 3 mL syringe (transparent polypropylene or polycarbonate syringe with Luer lock tip, graduation 0.1 mL) must be used.
Croatian: „mrtvim prostorom“ (prozirna polipropilenska ili polikarbonatna štrcaljka s Luer-Lock vrhom, graduirana po 0,1 ml).
English: ● Do not use the vial if: the medicine is cloudy, hazy or coloured.
Croatian: - ako je lijek mutan, zamagljen ili obojen
English: A syringe, a transfer needle (or vial adapter), and an injection needle are needed to withdraw the Hemlibra solution from the vial to a syringe and inject it under the skin (see section 7, “Instructions for use”).
Croatian: igla za prijenos (ili nastavak za bočicu) i igla za injiciranje (pogledajte dio 7.
English: All bleeds = bleeds treated and not treated with bypassing agents.
Croatian: Sva krvarenja: liječena krvarenja i ona koja nisu liječena lijekovima koji zaobilaze aktivnost faktora VIII.
English: The solution should be colourless to slightly yellow.
Croatian: Otopina mora biti bezbojna do blijedožuta.
English: The study also evaluated the efficacy of weekly Hemlibra prophylaxis compared with previous episodic (on-demand) and prophylactic bypassing agents (separate comparisons) in patients who had participated in the NIS prior to enrolment (Arms A and C, respectively) (see Table 7).
Croatian: („po potrebi“) odnosno profilaksu (zasebne usporedbe) u bolesnika koji su prije uključivanja sudjelovali u neintervencijskom ispitivanju (skupina A odnosno C) (vidjeti Tablicu 7).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1271/004
English: ● Keep the needle in the vial and turn the vial upside down.
Croatian: Držite iglu u bočici i preokrenite bočicu.
English: *Cavernous sinus thrombosis
Croatian: *tromboza kavernoznog sinusa manje često
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1271/002
English: Endpoints aABR (95% CI)
Croatian: Srednja vrijednost početnog rezultata (95% CI)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1271/001
English: ● Do not recap the injection needle with the cap.
Croatian: Nemojte vraćati zatvarač na iglu za injiciranje.
English: Guidance on the use of bypassing agents concomitantly with emicizumab and on the dosing recommendations for patients requiring treatment with bypassing agents in the perioperative setting;
Croatian: VIII te preporučeno doziranje u bolesnika kojima je u perioperacijskom razdoblju potrebno liječenje lijekovima koji zaobilaze akivnost faktora VIII
English: cMedian ABR (IQR) bN = 59
Croatian: bN = 59
English: Attach transfer needle to syringe
Croatian: Pričvrstite novu iglu za prijenos na štrcaljku
English: ● Do not detach injection needle
Croatian: 12. korak: Skinite zatvarač s igle za injiciranje
English: ● Use the syringes, vial adapters and injection needles only once.
Croatian: Svaku štrcaljku, nastavak za bočicu i iglu za injiciranje smijete upotrijebiti samo jednom.
English: ● Throw away any used caps, vial(s), needles and syringes in a sharps or puncture-proof container.
Croatian: Bacite sve upotrijebljene zatvarače, bočice, igle i štrcaljke u spremnik za odlaganje oštrih predmeta.
English: bMedian ABR (IQR)
Croatian: bMedijan anualizirane stope krvarenja (IKR)
English: Do not refrigerate the solution in the syringe.
Croatian: Nemojte zamrzavati lijek.
English: Median ABR (IQR) All Bleeds
Croatian: Medijan anualizirane stope krvarenja (IKR)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1271/003
English: Thrombophlebitis superficial
Croatian: Krvni ugrušci (tromboembolija)
English: Endpoint aABR (95% CI) bN = 59
Croatian: Srednja vrijednost promjene u odnosu na početni rezultat (95% CI) (n = 15)
English: ● Keep the vial adapter attached to the syringe and turn the vial upside down.
Croatian: Držite štrcaljku pričvršćenu na nastavak za bočicu i preokrenite bočicu.
English: Italia Roche S.p.A.
Croatian: N.V. Roche S.A.
English: ● The guide for laboratory professionals shall contain the following key messages: Chemical class, mode of action, pharmacodynamics and indication for emicizumab Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and not accurately reflect the patient's underlying hemostatic status during emicizumab prophylaxis.
Croatian: Informacije o utjecaju emicizumaba na određene laboratorijske testove koagulacije čime utječe na njihovu pouzdanost te oni ne odražavaju bolesnikov stvarni hemostatski status tijekom profilakse emicizumabom.
English: ● Followed by a maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks, from week 5 on: Patient bodyweight (kg) x dose (1.5; 3 or 6 mg/kg) = total amount (mg) of emicizumab to be administered
Croatian: Nakon toga, od 5. tjedna nadalje slijedi doza održavanja od 1,5 mg/kg jedanput na tjedan, 3 mg/kg svaka dva tjedna ili 6 mg/kg svaka četiri tjedna:
English: ABR=Annualized Bleed Rate, CI=confidence interval; IQR=interquartile range; 25th percentile to 75th percentile
Croatian: CI = interval pouzdanosti; IKR = interkvartilni raspon, od 25. percentila do 75. percentila
English: Route of administration
Croatian: Put primjene Unutarnje pakiranje
English: 240 ml (10 mg/ml) 1 bottle + 1 syringe + 1 adapter
Croatian: 240 ml (10 mg/ml) 1 boca + 1 štrcaljka +
English: Strength Pharmaceutical form Route of administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje
English: (Invented) name
Croatian: Ime
English: First read all the instructions carefully and then follow them step by step.
Croatian: Prvo pažljivo pročitajte sve upute a zatim ih slijedite korak po korak.
English: Wait 30 minutes for medication to warm.
Croatian: Pričekajte 30 minuta da se lijek ugrije.
English: CI 95 % for HR
Croatian: 95% CI za HR
English: • Wash your hands with soap and water, then dry them completely.
Croatian: • Operite ruke vodom i sapunom, potom ih potpuno osušite.
English: ≥ mNAPSI 75
Croatian: ≥ PASI 75
English: The injection button will unlock and be ready for use.
Croatian: Gumb za ubrizgavanje će se otkočiti i bit će spreman za uporabu.
English: • It is normal to see an air bubble.
Croatian: • Normalno je vidjeti mjehurić zraka.
English: > 32 weeks
Croatian: > 32 tjedna
English: - Not applicable.
Croatian: - Nije primjenjivo.
English: Read all of this leaflet carefully before you start using this medicine because it contains important
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama
English: • If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični na adalimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • DO NOT attempt to self-inject until you are sure that you understand how to prepare and give the
Croatian: • NE pokušavajte si dati injekciju dok niste sigurni da razumijete kako je pripremiti i ubrizgati.
English: 14 weeks
Croatian: 14 tjedana
English: ASAS 20 ASAS 5/6
Croatian: ASAS 5/6
English: Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period.
Croatian: Budući da eliminacija adalimumaba može trajati i do četiri mjeseca, praćenje je potrebno nastaviti tijekom cijelog tog razdoblja.
English: • It is normal to see one or more bubbles in the medication.
Croatian: • Normalno je vidjeti jedan ili više mjehurića zraka u lijeku.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje
English: a, b c, d a, b
Croatian: c,d,e
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: The air bubble does not need to be removed prior to injection.
Croatian: Nije potrebno ukloniti mjehurić zraka prije injekcije.
English: Your doctor may decide to stop treatment.
Croatian: Možda će odlučiti prekinuti liječenje.
English: • After proper training, the injection can be given by yourself or given by another person, for example, a
Croatian: • Nakon primjerene obuke, injekciju si možete dati sami ili Vam je može dati druga osoba, na primjer, član obitelji ili prijatelj.
English: • Do not touch this area again before injecting.
Croatian: • Ne dotičite ponovno taj predio prije ubrizgavanja.
English: Injecting medication that is cold can cause discomfort.
Croatian: Ubrizgavanje hladnog lijeka može uzrokovati nelagodu.
English: Always take the outer carton of the medicine with you, even if it is empty.
Croatian: Vanjsko pakiranje lijeka uvijek ponesite sa sobom, čak i ako je
English: Detailed instructions on how to inject Cyltezo are provided in section 7 ‘Instructions for use'.
Croatian: Detaljne upute kako ubrizgati lijek Cyltezo nalaze se u dijelu 7 „Upute za primjenu“.
English: Gather supplies onto clean, flat surface: a.
Croatian: Prikupite potreban pribor na čistu, ravnu površinu: a.
English: If you accidentally inject Cyltezo more frequently than you should, call your doctor or pharmacist and explain that you have taken more.
Croatian: Ako slučajno primijenite lijek Cyltezo češće nego što ste trebali, nazovite svog liječnika ili ljekarnika i objasnite da ste uzeli veću količinu.
English: In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life
Croatian: U nekim rijetkim slučajevima, osobito ako uzimate druge lijekove koji potiskuju imunološki sustav, reaktivacija infekcije HBV-om može biti opasna po život.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active HBV infection or if you think you might be at risk of contracting HBV.
Croatian: • Obavijestite svog liječnika ako ste nositelj virusa hepatitisa B (HBV), ako imate aktivnu infekciju HBV-om ili mislite da biste se mogli zaraziti HBV-om.
English: If you use more Cyltezo than you should
Croatian: Ako primijenite više lijeka Cyltezo nego što ste trebali
English: If you do not have all the supplies listed above, contact your pharmacist before proceeding.
Croatian: Ako nemate sav gore navedeni pribor, obratite se ljekarniku prije no što nastavite.
English: • Select a different site each time you inject at least 2.5 centimetres away from a previous site.
Croatian: • Za svaku primjenu injekcije odaberite različito mjesto koje je barem 2,5 centimetara udaljeno od prethodnog mjesta primjene injekcije.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies
Croatian: * detaljnije informacije se mogu pronaći u dijelovima 4.3, 4.4 i 4.8 ** uključujući otvorena produljenja ispitivanja uključujući podatke iz spontanog prijavljivanja
English: There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.
Croatian: Možda će biti potrebno prekinuti liječenje, primjerice prije kirurškog zahvata ili u slučaju ozbiljne infekcije.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet o primjeni ovog lijeka.
English: There is a window on each side of the pen through which you can see the Cyltezo solution inside the syringe.
Croatian: Na svakoj strani brizgalice nalazi se prozorčić kroz koji možete vidjeti otopinu lijeka Cyltezo unutar štrcaljke.
English: The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established.
Croatian: Sigurnost i djelotvornost adalimumaba u djece u dobi od 4 do 17 godina nisu još ustanovljene.