FrancophonIA/ELRC3.0 huggingface dataset:
English: In the fourth study, Orencia in combination with methotrexate was compared with Orencia alone and methotrexate alone in 351 adults who had not been treated with methotrexate (or with any biologic agents such as TNF alpha blockers), but may have been on other medicines for management of rheumatoid arthritis.
Croatian: U četvrtom je ispitivanju lijek Orencia u kombinaciji s metotreksatom uspoređen s monoterapijom lijekom Orencia i monoterapijom metotreksatom u 351 odrasle osobe koje prethodno nisu liječene metotreksatom (ni bilo kojim biološkim agensom poput TNF-alfa blokatora), ali su možda uzimale druge lijekove za liječenje reumatoidnog artritisa.
English: The European Medicines Agency concluded that Orencia had a modest anti-inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, it reduced the worsening of joint damage and improved physical function.
Croatian: Europska agencija za lijekove zaključila je da Orencia ima blago protuupalno djelovanje u liječenju reumatoidnog artritisa te da u kombinaciji s metotreksatom smanjuje pogoršavanje oštećenja zglobova i poboljšava fizičku funkciju.
English: The Agency decided that Orencia's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi od lijeka Orencia nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Orencia was found effective in one main study involving 424 adult patients with psoriatic arthritis.
Croatian: Lijek Orencia pokazao se učinkovitim u jednom glavnom ispitivanju koje je obuhvaćalo 424 odrasla bolesnika s psorijatičnim artritisom.
English: The main measure of effectiveness was how long it was before the patient's disease flared up again.
Croatian: Glavno mjerilo učinkovitosti bilo je vrijeme proteklo do pogoršanja bolesti.
English: What benefits has Orencia have been shown in studies?
Croatian: Koje su koristi od lijeka Orencia dokazane u ispitivanjima?
English: T cells are immune system cells that are involved in causing the inflammation in rheumatoid, psoriatic and polyarticular juvenile idiopathic arthritis.
Croatian: T-stanice su stanice imunosnog sustava koje su uključene u nastanak upale kod reumatoidnog, psorijatičnog i poliartikularnog juvenilnog idiopatskog artritisa.
English: Orencia was also shown to reduce symptoms of psoriatic arthritis.
Croatian: Utvrđeno je i da se primjenom lijeka Orencia ublažavaju simptomi psorijatičnog artritisa.
English: The third study included 391 patients in whom TNF blockers had not worked well enough.
Croatian: Trećim ispitivanjem bio je obuhvaćen 391 bolesnik u kojeg TNF-blokatori nisu bili dovoljno djelotvorni.
English: The active substance in Orencia, abatacept, is a protein that suppresses the activation of T cells.
Croatian: Djelatna tvar lijeka Orencia, abatacept, protein je koji potiskuje aktiviranje T-stanica.
English: A further study in 219 children with polyarticular juvenile idiopathic arthritis aged 2 to 17 years showed that Orencia given by injection under the skin produced expected levels of active substance in the blood based on data with Orencia given into a vein for other conditions.
Croatian: Dodatno ispitivanje kojim je bilo obuhvaćeno 219 djece u dobi od dvije do 17 godina oboljele od poliartikularnog juvenilnog idiopatskog artritisa pokazalo je da se primjenom lijeka Orencia injekcijom pod kožu postiže očekivana razina djelatne tvari u krvi s obzirom na podatke o intravenskoj primjeni lijeka Orencia za druga stanja.
English: • moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), in adolescents and children from 2 years of age in whom other medicines have not worked well enough.
Croatian: • umjerenog do teškog oblika aktivnog poliartikularnog juvenilnog idiopatskog artritisa (rijetke dječje bolesti koja uzrokuje upalu brojnih zglobova) u adolescenata i djece u dobi od dvije godine i starije u kojih drugi lijekovi nisu bili dovoljno djelotvorni.
English: Orencia is available as a powder that is made up into a solution for infusion (drip) into a vein and as a solution for injection under the skin in pre-filled syringes and pre-filled pens.
Croatian: Lijek Orencia dostupan je kao prašak od kojeg se priprema otopina za intravensku infuziju (ukapavanje) i kao otopina za potkožnu injekciju u napunjenim štrcaljkama ili napunjenim brizgalicama.
English: Four main studies involving a total of 1,733 adults found Orencia effective in rheumatoid arthritis.
Croatian: Četiri glavna ispitivanja kojima su bile obuhvaćene ukupno 1 733 odrasle osobe pokazala su da je lijek Orencia učinkovit u liječenju reumatoidnog artritisa.
English: • moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints) in adults using it in combination with methotrexate when other medicines including methotrexate or a ‘tumour necrosis factor (TNF) blocker' have not worked well enough;
Croatian: • umjerenog do teškog aktivnog reumatoidnog artritisa (bolesti imunosnog sustava koja uzrokuje oštećenja i upalu zglobova) u odraslih osoba, koje ga primjenjuju u kombinaciji s metotreksatom kada drugi lijekovi koji sadržavaju metotreksat ili „blokator faktora nekroze tumora (TNF-blokator)” nisu bili dovoljno djelotvorni;
English: Orencia contains the active substance abatacept.
Croatian: Orencia sadržava djelatnu tvar abatacept.
English: • psoriatic arthritis (arthritis combined with psoriasis, a condition causing red, scaly patches on the skin) in adults in whom treatment with other medicines, including methotrexate, has not worked well enough.
Croatian: • psorijatičnog artritisa (kombinacije artritisa i psorijaze, bolesti koja uzrokuje crvene, ljuskave lezije na koži) u odraslih osoba u kojih liječenje drugim lijekovima, uključujući metotreksat, nije bilo dovoljno djelotvorno.
English: The second study found a similar effect of Orencia on symptoms of rheumatoid arthritis, as well as improved physical function and a reduced rate of joint damage after a year of treatment.
Croatian: Drugim je ispitivanjem utvrđen sličan učinak lijeka Orencia na simptome reumatoidnog artritisa, kao i poboljšanje fizičke funkcije te smanjenje oštećenja zglobova nakon godinu dana terapije.
English: It is used in combination with methotrexate, or on its own in patients who cannot take methotrexate.
Croatian: Primjenjuje se u kombinaciji s metotreksatom ili kao monoterapija u bolesnika koji ne mogu primati metotreksat;
English: In addition, a study involving around 1,370 patients with rheumatoid arthritis found similar benefit for both Orencia given by injection under the skin and Orencia given by infusion.
Croatian: Osim toga, ispitivanje koje je obuhvaćalo otprilike 1 370 bolesnika s reumatoidnim artritisom pokazalo je slične koristi pri primjeni lijeka Orencia potkožnom injekcijom i primjeni lijeka Orencia infuzijom.
English: It is used alone or in combination with methotrexate for patients who do not need other medicines by mouth or by injection to control their psoriasis.
Croatian: Primjenjuje se kao monoterapija ili u kombinaciji s metotreksatom u bolesnika koji za kontrolu psorijaze ne trebaju druge lijekove koji se primjenjuju kroz usta ili injekcijom.
English: In another study involving 170 patients with psoriatic arthritis, Orencia given by infusion at the recommended dose reduced symptoms by at least 20% after 24 weeks in over 47% of the patients (19 out of 40) compared with 19% of the patients (8 out of 42) who received placebo.
Croatian: U drugom ispitivanju koje je obuhvaćalo 170 bolesnika s psorijatičnim artritisom, primjenom preporučene doze lijeka Orencia infuzijom simptomi su se smanjili za barem 20 % nakon 24 tjedna u više od 47 % bolesnika (19 od 40), u usporedbi s 19 % bolesnika (8 od 42) koji su primali placebo.
English: In around 60% of these patients the TNF alpha blocker had not worked well enough.
Croatian: TNF-alfa blokator nije bio dovoljno djelotvoran u otprilike 60 % tih bolesnika.
English: Orencia given by injection under the skin reduced symptoms in 39% of the patients (84 out of 213) compared with 22% of the patients (47 out of 211) who received placebo.
Croatian: Primjenom lijeka Orencia injekcijom pod kožu ublaženi su simptomi u 39 % bolesnika (84 od 213), u usporedbi s 22 % bolesnika (47 od 211) koji su primali placebo.
English: Adding Orencia and methotrexate to existing treatment for 12 months reduced symptoms in 61% of the patients (70 out of 115), compared with 42% of the patients on Orencia alone (48 out of 113) and 45% of the patients on methotrexate alone (52 out of 115).
Croatian: Dodavanjem lijeka Orencia i metotreksata postojećem liječenju tijekom 12 mjeseci ublaženi su simptomi u 61 % bolesnika (70 od 115), u usporedbi s 42 % bolesnika koji su primali samo lijek Orencia (48 od 113) i 45 % bolesnika koji su primali samo metotreksat (52 od 115).
English: How is Orencia used?
Croatian: Kako se Orencia primjenjuje?
English: Adding Orencia to existing treatment led to a reduction in symptoms in 50% of the patients (129 out of 256) after 6 months, compared with 20% of the patients adding placebo (26 out of 133).
Croatian: Dodavanjem lijeka Orencia postojećem liječenju ublaženi su simptomi u 50 % bolesnika (129 od 256) nakon šest mjeseci, u usporedbi s 20 % bolesnika kojima je dodan placebo (26 od 133).
English: Over 6 months, 20% of the patients receiving Orencia had a flare-up (12 out of 60), compared with 53% of those receiving placebo (33 out of 62).
Croatian: Tijekom šest mjeseci došlo je do pogoršanja u 20 % bolesnika koji su primali lijek Orencia (12 od 60) u usporedbi s 53 % onih koji su primali placebo (33 od 62).
English: In the first study, symptoms of the disease were reduced in 61% (70 out of 115) of the patients adding the recommended dose of Orencia to methotrexate for 6 months, compared with 35% (42 out of 119) of the patients adding placebo (a dummy treatment).
Croatian: U prvom ispitivanju simptomi bolesti ublaženi su u 61 % (70 od 115) bolesnika dodavanjem preporučene doze lijeka Orencia terapiji metotreksatom tijekom šest mjeseci, u usporedbi s 35 % (42 od 119) bolesnika kojima je dodan placebo (prividno liječenje).
English: The study also led to similar improvements in symptoms to those seen with Orencia given into a vein in adults and children.
Croatian: Tijekom ispitivanja zabilježeno je slično ublažavanje simptoma kao i prilikom intravenske primjene lijeka Orencia u odraslih i djece.
English: The injection can be given at any time during the day, but at the same time each day.
Croatian: Injekcija se može dati u bilo koje doba dana, ali svakoga dana u isto vrijeme.
English: Baseline values for these parameters were similar in the two groups.
Croatian: Početne vrijednosti za te parametre su bile slične u obje skupine.
English: No change in dose (target)
Croatian: Nema promjene doze (cilj)
English: Date of last renewal: 16 April 2009
Croatian: Datum posljednje obnove odobrenja: 16. travnja 2009.
English: How often to inject
Croatian: Koliko često injicirati
English: 41% 32% Odds Ratio:
Croatian: 41% 32% Omjer vjerojatnosti:
English: Difference:
Croatian: Razlika:
English: What Levemir is and what it is used for
Croatian: Što je Levemir i za što se koristi
English: * see section 4.8, Description of selected adverse reactions.
Croatian: * vidjeti dio 4.8, Opis odabranih nuspojava
English: Your dose may have to be adjusted by your doctor if:
Croatian: Liječnik će Vam možda morati prilagoditi dozu ako:
English: Animal data do not indicate reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na reproduktivnu toksičnost (vidjeti dio 5.3).
English: ► If it has not been stored correctly or been frozen, see section 5, How to store Levemir.
Croatian: ► ako nije ispravno čuvan ili ako je bio zamrznut, vidjeti dio 5. Kako čuvati Levemir.
English: Levemir must be protected from excessive heat and light.
Croatian: Levemir se mora zaštititi od prevelike topline i svjetlosti.
English: Levemir twice daily
Croatian: Levemir dva puta dnevno
English: The terminal half-life is between 5 and 7 hours depending on the dose.
Croatian: Terminalni poluvijek iznosi između 5 i 7 sati, ovisno o dozi.
English: Most of the injection site reactions are minor and of a transitory nature, i.e. they normally disappear during continued treatment in a few days to a few weeks.
Croatian: Većina reakcija na mjestu injiciranja su blage i prolazne naravi, dakle normalno nestaju tijekom daljnjeg liječenja kroz nekoliko dana do nekoliko tjedana.
English: • Drink alcohol (see section 2 Drinking alcohol and taking Levemir).
Croatian: • pijete alkohol (vidjeti dio 2. Konzumiranje alkohola i primjena lijeka Levemir).
English: Discuss this with your doctor.
Croatian: Porazgovarajte o tome sa svojim liječnikom.
English: Careful monitoring is recommended in these patients.
Croatian: Preporučuje se pomno nadzirati ove bolesnike.
English: Levemir can be used in elderly patients.
Croatian: Levemir se može koristiti u starijih bolesnika.
English: Levemir which has been frozen must not be used.
Croatian: Levemir koji je bio zamrznut ne smije se primijeniti.
English: Overall number of major hypoglycaemia episodes during pregnancy (per patient year)
Croatian: Ukupan broj teških epizoda hipoglikemije tijekom trudnoće (na bolesnica-godinu)
English: What you need to know before you use Levemir
Croatian: Što morate znati prije nego počnete primjenjivati Levemir
English: The manufacturer can be identified by the batch number printed on the slip of the carton and on the label: - If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Croatian: Proizvođač se može identificirati pomoću serijskog broja otisnutog na kutiji i naljepnici: - Ako su druga i treća oznaka S6, P5, K7, R7, VG, FG ili ZF, proizvođač je Novo Nordisk A/S,
English: The duration of action is up to 24 hours depending on dose providing an opportunity for once or twice daily administration.
Croatian: Djelovanje traje do 24 sata, ovisno o dozi, što daje mogućnost primjene jednom ili dva puta dnevno.
English: Maximum serum concentration is reached between 6 and 8 hours after administration.
Croatian: Maksimalna koncentracija u serumu postiže se između 6 i 8 sati nakon primjene.
English: During use: Use within 6 weeks
Croatian: Tijekom uporabe: upotrijebiti unutar 6 tjedana.
English: Treatment with Levemir can be considered during pregnancy, but any potential benefit must be weighed against a possibly increased risk of an adverse pregnancy outcome.
Croatian: Može se razmotriti liječenje lijekom Levemir tijekom trudnoće, ali se svaka moguća korist od liječenja mora odvagnuti u odnosu na mogući povećani rizik od nepovoljnog ishoda trudnoće.
English: The most frequently reported adverse reaction during treatment is hypoglycaemia, please see section 4.8, Description of selected adverse reactions.
Croatian: Najčešće zabilježena nuspojava tijekom liječenja je hipoglikemija, molimo vidjeti dio 4.8, Opis odabranih nuspojava.
English: As the pharmacokinetics of Levemir has not been studied extensively in these populations, it is advised to monitor plasma glucose closely in these populations.
Croatian: Budući da farmakokinetika lijeka Levemir nije detaljno ispitivana u ovim populacijama, preporučuje se pomno pratiti vrijednosti glukoze u plazmi u ovim populacijama.
English: Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
Croatian: Pažljiva kontrola šećerne bolesti, a osobito sprječavanje hipoglikemije, važni su za zdravlje Vašeg djeteta.
English: Select the dose you need.
Croatian: Odaberite potrebnu dozu.
English: Time Since Insulin Injection (hours) Levemir ….. 0.2 U/kg 0.3 U/kg .
Croatian: Vrijeme od injekcije inzulina (sati) Levemir ….. 0,2 U/kg 0,3 U/kg . . . .0,4 U/kg
English: ► If you have very low albumin you need to carefully monitor your blood sugar level.
Croatian: ► ako imate vrlo niske razine albumina morate pomno pratiti razinu šećera u krvi.
English: You must never inject Levemir directly into a vein (intravenously) or muscle (intramuscularly).
Croatian: Ne smijete nikada injicirati Levemir izravno u venu (intravenski) ili mišić (intramuskularno).
English: • Screw the needle straight and tightly onto your InnoLet (picture A).
Croatian: • Navijte iglu ravno i čvrsto na InnoLet (slika A).
English: Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Croatian: Neki lijekovi utječu na razinu šećera u krvi, a to može značiti da će Vaša doza inzulina morati biti promijenjena.
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Croatian: Obavijestite liječnika, što je prije moguće, ako osjetite znakove zatajivanja srca kao što je neuobičajeni nedostatak zraka ili naglo povećanje tjelesne težine ili lokalizirano oticanje (edem).
English: Animal studies do not indicate harmful effects with respect to fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke vezane za plodnost.
English: This should be kept in mind if treatment with the combination of pioglitazone and Levemir is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Levemir.
English: The overall percentage of treated patients expected to experience adverse reactions is estimated to be 12%.
Croatian: Ukupan postotak liječenih bolesnika u kojih se očekuju nuspojave procjenjuje se na 12%.
English: *Insulin detemir is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Croatian: *Detemir inzulin proizveden je u Saccharomyces cerevisiae tehnologijom rekombinantne DNK.
English: Duration of action (hr) GIRmax (mg/kg/min) †estimated values
Croatian: Trajanje djelovanja (h) GIRmax (mg/kg/min) †procijenjene vrijednosti
English: Observed rates of minor hypoglycaemic episodes were similar and no severe hypoglycaemic episodes were observed in either group.
Croatian: Opažene stope epizoda blage hipoglikemije su bile slične i nisu opažene epizode teške hipoglikemije ni u jednoj skupini.
English: Levemir can be used in adolescents and children from the age of 1 year (see section 5.1).
Croatian: Levemir se može koristiti u adolescenata i djece u dobi od 1 godine (vidjeti dio 5.1).
English: Levemir CV (%)
Croatian: CV (%) CV (%)
English: From clinical investigations, it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6% of the patients treated with Levemir.
Croatian: U kliničkim je ispitivanjima utvrđeno da se teška hipoglikemija, definirana kao potreba za intervencijom druge osobe, javlja u približno 6% bolesnika liječenih lijekom Levemir.
English: Intramuscular administration should also be avoided.
Croatian: Treba izbjegavati i intramuskularnu primjenu.
English: When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Croatian: Kad je brizgalica prazna bacite je u otpad, bez nataknute igle, prema uputama liječnika, medicinske sestre, ljekarnika ili u skladu s lokalnim propisima.
English: Degradation of insulin detemir is similar to that of human insulin; all metabolites formed are inactive.
Croatian: Razgradnja detemir inzulina slična je razgradnji humanog inzulina; svi metaboliti su neaktivni.
English: For doses in the interval of 0.2-0.4 units/kg (U/kg), Levemir exerts more than 50% of its maximum effect from 3-4 hours and up to approximately 14 hours after dose administration.
Croatian: Za doze u rasponu od 0,2-0,4 jedinice/kg (U/kg), više od 50% ukupnog maksimalnog učinka lijeka Levemir postiže se u razdoblju od 3-4 sata do približno 14 sati nakon primjene doze.
English: Serious allergic reaction to Levemir or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening.
Croatian: Ozbiljna alergijska reakcija na Levemir ili neki od njegovih sastojaka (naziva se sistemska alergijska reakcija) je vrlo rijetka nuspojava, ali može biti opasna po život.
English: It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
Croatian: Može se koristiti i u kombinaciji s oralnim antidijabeticima i/ili agonistima GLP-1 receptora.
English: The trial including children above 2 years was extended for an additional 12 months (total of 24 months treatment data) to assess antibody formation after long-term treatment with Levemir.
Croatian: Ispitivanje u kojem su sudjelovala djeca starija od 2 godine produljeno je za dodatnih 12 mjeseci (terapijski podaci obuhvaćaju ukupno 24 mjeseca) kako bi se procijenilo stvaranje protutijela nakon dugotrajne terapije lijekom Levemir.
English: An apparent volume of distribution for Levemir (approximately 0.1 l/kg) indicates that a high fraction of insulin detemir is circulating in the blood.
Croatian: Prividni volumen distribucije lijeka Levemir (približno 0,1 l/kg) pokazuje da u krvi cirkulira velik udio detemir inzulina.
English: Glucose infusion rate (mg/kg/min)
Croatian: Brzina infuzije glukoze (mg/kg/min)
English: Results indicate that antibody development had no negative effect on glycaemic control and Levemir dose.
Croatian: Podaci ukazuju na to da razvoj protutijela nije imao negativan učinak na glikemijsku kontrolu i dozu lijeka Levemir.
English: Your InnoLet is designed to work accurately and safely.
Croatian: Održavanje brizgalice Vaš InnoLet napravljen je tako da radi točno i sigurno.
English: The pharmacokinetic properties of Levemir were investigated in young children (1-5 years), children (6-12 years) and adolescents (13-17 years) and compared to adults with type 1 diabetes.
Croatian: Farmakokinetička svojstva lijeka Levemir ispitivana su u male djece (1-5 godina), djece (6-12 godina) i adolescenata (13-17 godina) i uspoređena s odraslima sa šećernom bolešću tipa
English: Primary objective of this study was to assess the effect of Levemir on blood glucose regulation in pregnant women with diabetes (see section 5.1).
Croatian: Primarni cilj ovog ispitivanja bio je procijeniti učinak lijeka Levemir na regulaciju glikemije u trudnica sa šećernom bolešću (vidjeti dio 5.1).
English: Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose.
Croatian: Promjene u jačini, nazivu inzulina (proizvođač), vrsti, podrijetlu (životinjski inzulin, humani inzulin ili inzulinski analog) i/ili načinu proizvodnje (rekombinantna DNK u odnosu na inzulin životinjskog podrijetla) mogu rezultirati potrebom za promjenom doze.
English: Pharmacodynamic Parameters for Levemir and NPH
Croatian: Farmakodinamički parametri za Levemir i NPH
English: 1 unit insulin detemir corresponds to 1 international unit of human insulin.
Croatian: 1 jedinica detemir inzulina odgovara 1 internacionalnoj jedinici humanog inzulina.
English: Proportions of patients achieving HbA1c <7% targets
Croatian: Udio bolesnika koji su postigli ciljni HbA1c < 7% (%)
English: The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units.
Croatian: Jakost inzulinskih analoga, uključujući detemir inzulin, izražava se u jedinicama, dok se jakost humanog inzulina izražava u internacionalnim jedinicama.
English: Randomised liraglutide + metformin n=149
Croatian: Randomizirani na liraglutid + metformin n=149
English: What Levemir looks like and contents of the pack
Croatian: Kako Levemir izgleda i sadržaj pakiranja
English: Receptor affinity data and in vitro mitogenicity tests revealed no evidence of an increased mitogenic potential compared to human insulin.
Croatian: Podaci o afinitetu za receptore kao i ispitivanja mitogenosti in vitro nisu pokazali povećan mitogeni potencijal u odnosu na humani inzulin.