FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of LIFMIOR should be discontinued if a patient develops a serious infection.
Croatian: U slučaju razvoja ozbiljne infekcije primjena LIFMIORa mora se obustaviti.
English: You will be instructed by your doctor or his/her assistant on the techniques of self-injection or on giving an injection to a child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
Croatian: Nemojte pokušavati dati injekciju dok niste sigurni da razumijete kako injekciju pripremiti i dati.
English: LIFMIOR 25 mg powder and solvent for solution for injection etanercept
Croatian: LIFMIOR 25 mg prašak za injekciju etanercept
English: The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes, or particles.
Croatian: Otopina bi trebala biti bistra i bezbojna do blijedožuta ili blijedosmeđa, bez grudica, pahuljica ili čestica.
English: Each pre-filled syringe of LIFMIOR contains 50 mg etanercept.
Croatian: Jedna napunjena brizgalica LIFMIORa sadrži 50 mg etanercepta.
English: 24 pre-filled syringes 24 alcohol swabs
Croatian: 8 napunjenih štrcaljki 8 jastučića natopljenih alkoholom24 napunjene štrcaljke 24 jastučića natopljenih alkoholom
English: There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking LIFMIOR.
Croatian: U bolesnika koji su primali LIFMIOR nakon stavljanja u promet zabilježena su pogoršanja bolesti kongestivnog zatajenja srca, sa i bez ustanovljivih pospješujućih čimbenika.
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with LIFMIOR use.
Croatian: Tijekom primjene LIFMIORa rijetko su zabilježeni slučajevi središnje demijelinizacije, dok su slučajevi periferne demijelinizacije prijavljeni vrlo rijetko.
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject LIFMIOR."
Croatian: Iscrpne upute za primjenu navedene su u uputi o lijeku, u dijelu 7, “Upute za uporabu brizgalice MYCLIC za ubrizgavanje LIFMIORa”.
English: EXP
Croatian: HAQ
English: LIFMIOR 50 mg solution for injection in pre-filled syringe etanercept
Croatian: LIFMIOR 50 mg otopina za injekciju u napunjenoj štrcaljki etanercept
English: Renal impairment
Croatian: Dodavanje otapala
English: With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 19).
Croatian: Potom pritisnite klip kako biste sporo i ravnomjerno ubrizgali čitavu otopinu (vidjeti sliku 19).
English: Etanercept has been reported to be excreted in human milk following subcutaneous administration.
Croatian: Nakon supkutane primjene etanercept se izlučuje u mlijeko liječenih žena.
English: Posology
Croatian: Odgovor
English: Step 2: Choosing an injection site
Croatian: Korak 2: Odabir mjesta uboda
English: Each vial of LIFMIOR contains 25 mg etanercept.
Croatian: Jedna bočica LIFMIORa sadrži 25 mg etanercepta.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije primijeniti nakon isteka roka valjanosti navedenog na kutiji iza oznake „Rok valjanosti“ ili EXP.
English: The solution should be clear, colourless to pale yellow or pale brown, with no lumps or flakes or particles.
Croatian: Otopina treba biti bistra i bezbojna do blijedožuta ili blijedosmeđa, bez grudica, pahuljica i čestica.
English: Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8).
Croatian: Solidni tumori i hematopoetske zloćudne bolesti (izuzimajući rak kože) Nakon stavljanja lijeka u promet zabilježeni su slučajevi raznih zloćudnih bolesti (uključujući karcinome dojke i pluća te limfome) (vidjeti dio 4.8).
English: 28b a: p<0.001, LIFMIOR vs. placebo b: p = 0.002, LIFMIOR vs. placebo
Croatian: ASAS 70 2 tjedna 3 mjeseca 6 mjeseci p<0,001, LIFMIOR u odnosu na placebo p = 0,002, LIFMIOR u odnosu na placebo
English: With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 4).
Croatian: Potom pritisnite klip kako biste sporo i ravnomjerno ubrizgali čitavu otopinu (vidjeti sliku 4).
English: The 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Croatian: Za liječenje djece s juvenilnim idiopatskim artritisom tjelesne težine ispod 25 kg prikladnije su bočice LIFMIORa jačine 10 mg.
English: LIFMIOR 50 mg solution for injection in pre-filled pen Etanercept
Croatian: LIFMIOR 50 mg otopina za injekciju u napunjenoj brizgalici etanercept
English: 1 LIFMIOR vial
Croatian: Otapalo za LIFMIOR Supkutana primjena
English: Start again with another vial.
Croatian: Ponovite postupak s novom bočicom.
English: Aplastic anaemia*
Croatian: Pancitopenija* Aplastična anemija*
English: LIFMIOR 50 mg solution for injection in pre-filled pen.
Croatian: LIFMIOR 50 mg otopina za injekciju u napunjenoj brizgalici.
English: ASAS 5/6
Croatian: 6 jedinica/mg.
English: Comprehensive instructions for the preparation and administration of the reconstituted LIFMIOR vial are given in the package leaflet, section 7, “INSTRUCTIONS FOR PREPARATION AND GIVING AN INJECTION OF LIFMIOR”.
Croatian: Iscrpne upute za pripremu i primjenu rekonstituirane bočice LIFMIORa navedene su u uputi o lijeku, u dijelu 7, “Upute za pripremu i davanje injekcije LIFMIORa”.
English: Remissionc
Croatian: Doziranje
English: ASAS partial remission
Croatian: Prijavljivanje nuspojava
English: a. Introduction b. Setting up for an injection c.
Croatian: Priprema za injekciju c.
English: With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly, or with great force.
Croatian: S vremenom ćete naučiti odrediti kut koji Vama ili djetetu najviše odgovara.
English: No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients.
Croatian: Tijekom kliničkih ispitivanja u bolesnika s reumatoidnim artritisom nije zabilježen nijedan slučaj toksičnosti koji bi ograničavao dozu.
English: 50b
Croatian: 1050 Bruxelles
English: • Press a cotton ball over the injection site for 10 seconds.
Croatian: • Na mjestu davanja injekcije tijekom sljedećih 10 sekundi pritisnite komadić vate.
English: Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs.
Croatian: Srednje vrijednosti najnižih koncentracija u serumu u stanju dinamičke ravnoteže kretale su se od 1,6 do
English: For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), LIFMIOR can slow down the structural damage to those joints caused by the disease.
Croatian: LIFMIOR može usporiti napredovanje strukturnog oštećenja zglobova koje uzrokuje bolest u bolesnika s više simetrično bolnih ili otečenih zglobova (npr. šake, zapešća i stopala).
English: 1.0 ml (50 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Croatian: 12 (3 x 4) napunjenih brizgalica (višestruko pakiranje)
English: Pack size
Croatian: 1 napunjena brizgalica
English: Pack size bottle (HDPE)
Croatian: Unutarnje pakovanje Veličina pakovanja boca (HDPE)
English: Strength Pharmaceutical Form
Croatian: Farmaceutski oblik Put primjene
English: What X is and what it is used for
Croatian: Što je X i za što se koristi
English: Other medicines and X
Croatian: Drugi lijekovi i X
English: This combination apparently increases the risk for adverse events and is therefore not recommended.
Croatian: Ova kombinacija čini se povećava rizik od štetnih događaja i stoga se ne preporučuje.
English: “Your doctor may need to change your dose and/or to take other precautions:
Croatian: “Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza:
English: The study was terminated early because of an increased risk of adverse outcomes.
Croatian: Ispitivanje je bilo prijevremeno prekinuto zbog povećanog rizika od štetnih ishoda.
English: What X is and what it is used for “X can be used to treat symptomatic heart failure in adult patients.
Croatian: Što je X i za što se koristi “X se može koristiti za liječenje simptomatskog zatajenja srca u odraslih bolesnika.
English: These medicines are for the treatment of heart failure (see “Other medicines and X”).”
Croatian: Ti su lijekovi namijenjeni liječenju zatajenja srca (vidjeti “Drugi lijekovi i X”).”
English: “Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Croatian: “Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS)
English: Caution should be observed when initiating therapy in patients with heart failure.
Croatian: Potreban je oprez kod započinjanja terapije u bolesnika sa zatajenjem srca.
English: Section 5.1 - Pharmacodynamic properties
Croatian: Dio 5.1 - Farmakodinamička svojstva
English: Valsartan may be administered with other heart failure therapies.
Croatian: Valsartan se može primjenjivati s drugim terapijama za zatajenje srca.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Croatian: Dio 4.5 - Interakcije s drugim lijekovima i drugi oblici interakcija
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.
Croatian: S obzirom na njihova slična farmakodinamička svojstva, ti su rezultati relevantni i za druge ACE inhibitore i blokatore angiotenzin II receptora.
English: “Heart failure
Croatian: “Zatajenje srca
English: Section 4.1 - Therapeutic indications
Croatian: Dio 4.1 - Terapijske indikacije
English: Section 1.
Croatian: Dio 1.
English: Section 4.3 - Contraindication
Croatian: Dio 4.3 - Kontraindikacije
English: The following wording should be added to this section (for telmisartan-containing products that already have an extensive wording on ONTARGET in section 5.1, the following wording should be added in addition to the existing text, which should be maintained):
Croatian: U ovaj dio potrebno je dodati sljedeći tekst (za lijekove koji sadrže telmisartan, koji već imaju opsežan tekst o ispitivanju ONTARGET u dijelu 5.1, potrebno je dodati sljedeći tekst uz postojeći tekst, koji je potrebno zadržati):
English: Use of [Product name] in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Croatian: Primjena [naziv proizvoda] u bolesnika sa zatajenjem srca obično ima za posljedicu određeno sniženje krvnog tlaka, ali obično nije potrebno prekinuti terapiju zbog kontinuirane simptomatske hipotenzije pod uvjetom da se slijede upute o doziranju (vidjeti dio 4.2).
English: Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.
Croatian: Obavijestite svog <liječnika> <ili> <ljekarnika> ako <uzimate> <primjenjujete>, ili ste nedavno <uzeli> <primijenili> ili biste mogli <uzeti> <primijeniti> bilo koje druge lijekove.
English: In addition, the existing heart failure indication should be revised as follows:
Croatian: Osim toga, postojeću indikaciju zatajenja srca potrebno je revidirati kako slijedi:
English: Do not <take> <use> X <:>
Croatian: Nemojte <uzimati> <primjenjivati> X <:>
English: These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed.
Croatian: Ta ispitivanja nisu pokazala nikakav značajan povoljan učinak na bubrežne i/ili kardiovaskularne ishode i smrtnost, a bio je uočen povećani rizik od hiperkalemije, akutne ozljede bubrega i/ili hipotenzije u usporedbi s monoterapijom.
English: Section 4.4 - Special warnings and precautions for use
Croatian: Dio 4.4 - Posebna upozorenja i mjere opreza pri uporabi
English: “Concomitant therapy with an ACE-inhibitor in heart failure
Croatian: “Istodobna terapija ACE inhibitorom kod zatajenja srca
English: • “if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren”
Croatian: • “ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren”
English: Evaluation of patients with heart failure should always include assessment of renal function.”
Croatian: Ocjenjivanje stanja bolesnika sa zatajenjem srca uvijek mora uključivati procjenu bubrežne funkcije.”
English: Section 2.
Croatian: Dio 2.
English: Evaluation of patients with heart failure should always include assessment of renal function (see section 4.2).
Croatian: Ocjenjivanje stanja bolesnika sa zatajenjem srca uvijek mora uključivati procjenu bubrežne funkcije (vidjeti dio 4.2).
English: The following wording should be included as applicable in the specified sections: Section 1.
Croatian: U navedene dijelove potrebno je uključiti sljedeći tekst gdje je primjenjivo: Dio 1.
English: “[Product name] can be administered with other heart failure treatment, including ACE-inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products.
Croatian: “[Naziv lijeka] se može primjenjivati s drugim terapijama za zatajenje srca, što uključuje ACE inhibitore, beta-blokatore, diuretike i digitalis ili kombinaciju tih lijekova.
English: In patients whose renal function may depend on the activity of the renin-angiotensin-aldosteronesystem (e.g. patients with severe congestive heart failure), treatment with ACE-inhibitors has been associated with oliguria and/or progressive azotaemia and in rare cases with acute renal failure and/or death.
Croatian: U bolesnika čija bubrežna funkcija može ovisiti o aktivnosti renin-angiotenzin-aldosteronskog sustava (npr. u bolesnika s teškim kongestivnim zatajenjem srca), liječenje ACE inhibitorima bilo je povezano s oligurijom i/ili progresivnom azotemijom te u rijetkim slučajevima s akutnim zatajenjem bubrega i/ili smrću.
English: For products containing the angiotensin-converting enzyme inhibitors (ACE-inhibitors) benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Croatian: Za lijekove koji sadrže inhibitore angiotenzin konvertirajućeg enzima (ACE inhibitori) benazepril, kaptopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lizinopril, moeksipril, perindopril, kvinapril, ramipril, spirapril, trandolapril i zofenopril, postojeće informacije o lijeku se trebaju izmjeniti (umetanjem, zamjenom ili brisanjem teksta prema potrebi) da odražavaju dogovoreni tekst kao što je predviđeno u nastavku
English: ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage.
Croatian: ONTARGET je bilo ispitivanje provedeno u bolesnika s kardiovaskularnom ili cerebrovaskularnom bolešću u anamnezi, ili sa šećernom bolešću tipa 2 uz dokaze oštećenja ciljanih organa.
English: Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Croatian: Liječnik Vam može provjeravati bubrežnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u krvi u redovitim intervalima.
English: The combination of an ACE-inhibitor, a potassium-sparing diuretic and [Product name] is not recommended and should be considered only after careful evaluation of the potential benefits and risks (see sections 4.4, 4.8 and 5.1).”
Croatian: Kombinacija ACE inhibitora, diuretika koji štede kalij i [naziv lijeka] ne preporučuje se i smije se uzeti u obzir samo nakon pažljive procjene potencijalnih koristi i rizika (vidjeti dijelove 4.4, 4.8 i
English: In patients with heart failure, the triple combination of an ACE-inhibitor, a beta blocker and [Product name] has not shown any clinical benefit (see section 5.1).
Croatian: U bolesnika sa zatajenjem srca, trostruka kombinacija ACE inhibitora, beta blokatora i [naziv lijeka] nije pokazala nikakvu kliničku korist (vidjeti dio 5.1).
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Croatian: ALTITUDE (eng. Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) je bilo ispitivanje osmišljeno za testiranje koristi dodavanja aliskirena standardnoj terapiji s ACE inhibitorom ili blokatorom angiotenzin II receptora u bolesnika sa šećernom bolešću tipa 2 i kroničnom bolešću bubrega, kardiovaskularnom bolešću ili oboje.
English: As valsartan is an angiotensin II receptor blocker, it cannot be excluded that the use of [Product name] may be associated with impairment of the renal function.
Croatian: Budući da je valsartan blokator angiotenzin II receptora, ne može se isključiti da primjena [naziv lijeka] može biti povezana s oštećenjem bubrežne funkcije.
English: X is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE-inhibitors when other medications to treat heart failure cannot be used.”
Croatian: X se koristi kada se skupina lijekova pod nazivom inhibitori angiotenzinkonvertirajućeg enzima (ACE) (lijek za liječenje zatajenja srca) ne može koristiti ili se može koristiti uz ACE inhibitore kada se drugi lijekovi za liječenje zatajenja srca ne mogu koristiti.”
English: [Product name] may be co-administered with an ACE-inhibitor in patients with symptomatic heart failure despite optimal standard heart failure therapy when mineralocorticoid receptor antagonists are not tolerated.
Croatian: [Naziv lijeka] se može primjenjivati istodobno s ACE inhibitorom u bolesnika sa simptomatskim zatajenjem srca usprkos optimalnoj standardnoj terapiji za zatajenje srca kada se antagonisti mineralokortikoidnog receptora ne podnose.
English: Annex II Amendments to relevant sections of the summary of product characteristics and package leaflet
Croatian: Dodatak II Izmjene odgovarajućih dijelova Sažetka opisa svojstava lijeka i Upute o lijeku
English: What you need to know before you <take> <use> X
Croatian: Što morate znati prije nego počnete <uzimati> <primjenjivati> X
English: See also information under the heading “Do not <take> <use> X””
Croatian: Vidjeti također informacije pod naslovom “Nemojte <uzimati> <primjenjivati> X””
English: However, the triple combination of an ACE-inhibitor, valsartan and a beta blocker or a potassium-sparing diuretic is not recommended (see sections 4.4 and 5.1).
Croatian: Međutim, trostruka kombinacija ACE inhibitora, valsartana i beta blokatora ili diuretika koji štedi kalij se ne preporučuje (vidjeti dijelove 4.4 i 5.1).
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.”
Croatian: Kardiovaskularna smrt i moždani udar oboje su numerički bili učestaliji u skupini koja je primala aliskiren nego u onoj koja je primala placebo, a štetni događaji i ozbiljni štetni događaji od značaja (hiperkalemija, hipotenzija i bubrežna disfunkcija) bili su učestalije zabilježeni u skupini koja je primala aliskiren nego u onoj koja je primala placebo.”
English: “Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Croatian: ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) i VA NEPHRON-D (eng. The Veterans Affairs Nephropathy in Diabetes)) ispitivala su primjenu kombinacije ACE inhibitora s blokatorom angiotenzin II receptora.
English: For products containing the angiotensin II receptor blockers azilsartan, eprosartan, irbesartan, losartan, olmesartan and telmisartan, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Croatian: Za lijekove koji sadrže blokatore angiotenzin II receptora azilsartan, eprosartan, irbesartan, losartan, olmesartan i telmisartan, postojeće informacije o lijeku se trebaju izmjeniti (umetanjem, zamjenom ili brisanjem teksta prema potrebi) da odražavaju dogovoreni tekst kao što je predviđeno u nastavku
English: Triple combination of an ACE-inhibitor, a mineralocorticoid receptor antagonist and candesartan is also not recommended.
Croatian: Trostruka kombinacija ACE inhibitora, antagonista mineralokortikoidnog receptora i kandesartana također nije preporučljiva.
English: What you need to know before you <take> <use> X Do not <take> <use> X <:>
Croatian: Što morate znati prije nego počnete <uzimati> <primjenjivati> X Nemojte <uzimati> <primjenjivati> X <:>
English: Dual blockade of the RAAS by combining aliskiren with an ACEinhibitor or an angiotensin II receptor blocker is therefore not recommended.
Croatian: Stoga se ne preporučuje dvostruka blokada RAAS-a kombiniranjem aliskirena s ACE inhibitorom ili blokatorom angiotenzin II receptora.
English: Triple combination of an ACE-inhibitor, a mineralocorticoid receptor antagonist and valsartan is also not recommended.
Croatian: Trostruka kombinacija ACE inhibitora, antagonista mineralokortikoidnih receptora i valsartana također se ne preporučuje.
English: The following contraindication should be added to this section:
Croatian: U ovaj dio potrebno je dodati sljedeću kontraindikaciju:
English: The risk of adverse reactions, especially hypotension, hyperkalaemia and decreased renal function (including acute renal failure), may increase when [Product name] is used in combination with an ACEinhibitor.
Croatian: Rizik od nuspojava, naročito hipotenzije, hiperkalijemije i smanjene funkcije bubrega (uključujući akutno zatajenje bubrega), može se povećati kada se [Naziv lijeka] koristi u kombinaciji s ACE inhibitorom.
English: Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Croatian: Dvostruka blokada RAAS-a kombiniranom primjenom ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena stoga se ne preporučuje (vidjeti dijelove 4.5 i 5.1).
English: • if you are taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptors antagonists (MRA).
Croatian: • ako uzimate ACE inhibitor zajedno s lijekom koji pripada skupini lijekova poznatih pod nazivom antagonisti mineralokortikoidnog receptora (MRA).
English: VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
Croatian: VA NEPHROND je bilo ispitivanje u bolesnika sa šećernom bolešću tipa 2 i dijabetičkom nefropatijom.