FrancophonIA/ELRC3.0 huggingface dataset:
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Croatian: Za potrebe liječenja maničnih epizoda u bolesnika u dobi između 13 i 17 godina, početna doza iznosi 2 mg na dan (primjenom lijeka koji sadrži aripiprazol dostupnog u tekućem obliku) i postupno se povećava do preporučene doze od 10 mg jednom na dan.
English: For further information, see the Summary of Product Characteristics (also part of the EPAR).
Croatian: Dodatne informacije pročitajte u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: Why is Aripiprazole Accord approved?
Croatian: Zašto je lijek Aripiprazole Accord odobren?
English: How does Aripiprazole Accord work?
Croatian: Kako djeluje Aripiprazole Accord?
English: For practical information about using Aripiprazole Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Accord pročitajte u uputi o lijeku ili se obratite svojem liječniku ili ljekarniku.
English: How is Aripiprazole Accord used?
Croatian: Kako se koristi Aripiprazole Accord?
English: How has Aripiprazole Accord been studied?
Croatian: Kako je Aripiprazole Accord ispitivan?
English: Further information on Remicade can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Remicade.
Croatian: Više informacija o lijeku Remicade nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Remicade.
English: The dose is 5 mg per kilogram for the other diseases.
Croatian: Za ostale se bolesti daje doza od 5 mg po kilogramu.
English: What measures are being taken to ensure the safe and effective use of Remicade?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Remicade?
English: Remicade is given as an infusion lasting one or two hours.
Croatian: Remicade se daje infuzijom u trajanju od jednog ili dva sata.
English: Remicade is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Croatian: Remicade se obično daje u dozi od 3 mg po kilogramu tjelesne težine u slučaju reumatoidnog artritisa, a doza se prema potrebi može i povećati.
English: It is usually used when other medicines or treatments have failed, in adults with the following diseases:
Croatian: Obično se primjenjuje u slučajevima kada drugi lijekovi ili načini liječenja nisu bili uspješni u odraslih osoba oboljelih od:
English: Other information about Remicade
Croatian: Ostale informacije o lijeku Remicade
English: What is Remicade and what is it used for?
Croatian: Što je Remicade i za što se primjenjuje?
English: The effects of adding Remicade to existing treatment have also been studied in 103 children and adolescents with Crohn's disease who were aged between 6 and 17 years.
Croatian: Učinak dodavanja lijeka Remicade postojećem liječenju ispitano je i u 103 djece i adolescenata oboljelih od Crohnove bolesti u dobi između 6 i 17 godina.
English: Remicade is also used in patients aged between 6 and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Croatian: Remicade se primjenjuje i u bolesnika u dobi između 6 i 17 godina s teškom, aktivnom Crohnovom bolesti ili teškim aktivnim ulcerativnim kolitisom ako nisu odgovorili na druge lijekove ili načine liječenja odnosno ne mogu ih primati.
English: A sixth study in 508 adult patients looked at the number of patients whose symptoms improved and who did not need additional treatment with corticosteroids (other medicines used in Crohn's disease).
Croatian: U šestom ispitivanju, koje je provedeno među 508 odraslih bolesnika, promatrao se broj bolesnika čiji su simptomi ublaženi i koji nisu trebali dodatno liječenje kortikosteroidima (drugi lijekovi koji se primjenjuju za liječenje Crohnove bolesti).
English: As for all medicines, data on the use of Remicade are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Remicade kontinuirano se prate.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remicade or the infusion time may be slowed down.
Croatian: Kako bi se smanjio rizik od reakcija povezanih s infuzijom, bolesnicima se mogu dati drugi lijekovi prije ili nakon lijeka Remicade ili se infuzija može usporiti.
English: Remicade received a marketing authorisation valid throughout the EU on 13 August 1999.
Croatian: Lijek Remicade dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 13. kolovoza
English: Side effects reported with Remicade are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Remicade pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: In a study with 60 children aged between 6 and 17 years with ulcerative colitis 73% of patients responded to treatment with Remicade at week eight (44 out of 60).
Croatian: U ispitivanju provedenom među 60 djece u dobi između 6 i 17 godina oboljele od ulcerativnog kolitisa, 73 % bolesnika (tj. 44 od 60) odgovorilo je na liječenje lijekom Remicade u osmom tjednu.
English: An overview of Remicade and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Remicade i zašto je odobren u EU-u
English: Remicade must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Croatian: Remicade se ne smije primjenjivati u bolesnika s tuberkulozom, drugim teškim infekcijama ili umjerenim ili teškim zatajenjem srca (nemogućnost srca da pumpa dovoljne količine krvi u tijelu).
English: The European Medicines Agency decided that Remicade's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Remicade nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The most common side effects with Remicade (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Croatian: Najčešće su nuspojave lijeka Remicade (opažene u više od 1 na 10 bolesnika) virusne infekcije (kao što su gripa ili herpes), glavobolja, infekcije gornjeg respiratornog trakta (prehlade), sinusitis (upala sinusa), mučnina, abdominalna bol (bol u trbuhu), reakcije i bol povezani s infuzijom.
English: Remicade has been studied in a total of 1,432 patients with rheumatoid arthritis in two studies.
Croatian: Lijek Remicade ispitan je na ukupno 1 432 bolesnika s reumatoidnim artritisom u dvama ispitivanjima.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Remicade have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Remicade nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: Remicade is an anti-inflammatory medicine.
Croatian: Remicade je protuupalni lijek.
English: Remicade is used with methotrexate (a medicine that acts on the immune system);
Croatian: Remicade se primjenjuje s metotreksatom (lijekom koji djeluje na imunosni sustav),
English: Patients who receive Remicade must be given a special reminder card.
Croatian: Bolesnicima koji primaju lijek Remicade mora se dati posebna kartica s upozorenjima.
English: Most of the patients showed a reduction in symptoms after adding Remicade to their existing treatment.
Croatian: U većine bolesnika opaženo je ublažavanje simptoma nakon dodavanja lijeka Remicade njihovom postojećem liječenju.
English: What are the risks associated with Remicade?
Croatian: Koji su rizici povezani s lijekom Remicade?
English: For more information about using Remicade, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Remicade pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The card will include safety information about the medicine and a record of the dates and results of specific tests that the patient has had so these can be shared with any treating doctor.
Croatian: Kartica će sadržavati informacije o sigurnosti primjene lijeka te popis datuma i rezultata posebnih testova kojima je bolesnik bio podvrgnut kako bi s njima bili upoznati svi liječnici koji sudjeluju u njegovu liječenju.
English: The patients were treated for 6 months with Remicade, another medicine azathioprine, or the combination of Remicade and azathioprine.
Croatian: Bolesnici su šest mjeseci primali lijek Remicade, drugi lijek naziva azatioprin ili kombinaciju lijeka Remicade i azatioprina.
English: Remicade can only be obtained with a prescription and must be given under the supervision and monitoring of a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remicade can be used to treat.
Croatian: Remicade se izdaje samo na liječnički recept, a primjenu lijeka mora nadzirati i pratiti liječnik specijalist s iskustvom u dijagnosticiranju i liječenju bolesti za koje se Remicade može primjenjivati.
English: Remicade must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remicade.
Croatian: Remicade se ne smije primjenjivati u bolesnika koji su u prošlosti pokazali preosjetljivost (alergiju) na infliksimab ili koji su preosjetljivi (alergični) na bjelančevine mišjeg podrijetla ili bilo koji drugi sastojak lijeka Remicade.
English: The active substance in Remicade, infliximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Croatian: Djelatna tvar lijeka Remicade je infliksimab, monoklonsko protutijelo, vrsta bjelančevina koja prepoznaje i vezuje se na određenu strukturu (antigen) u tijelu.
English: Why is Remicade authorised in the EU?
Croatian: Zašto je lijek Remicade odobren u EU-u?
English: Remicade alone and in combination with azathioprine was more effective than azathioprine alone.
Croatian: Lijek Remicade, primijenjen samostalno ili u kombinaciji s azatioprinom, bio je učinkovitiji od monoterapije azatioprinom.
English: Ulcerative colitis, ankylosing spondylitis and psoriatic arthritis For ulcerative colitis (728 adults), ankylosing spondylitis (70 adults) and psoriatic arthritis (104 adults), Remicade has been compared with placebo.
Croatian: Lijek Remicade uspoređen je s placebom za liječenje ulcerativnog kolitisa (728 odraslih osoba), ankilozantnog spondilitisa (70 odraslih osoba) i psorijatičnog artritisa (104 odrasle osobe).
English: What benefits of Remicade have been shown in studies?
Croatian: Koje su koristi od lijeka Remicade utvrđene u ispitivanjima?
English: Remicade is available as a powder that is made up into a solution for infusion (drip into a vein).
Croatian: Lijek Remicade dostupan je kao prašak za pripremu otopine za infuziju (drip u venu).
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
Croatian: • Crohnove bolesti (bolesti koja uzrokuje upalu probavnog sustava) ako je bolest umjerena do teška ili fistulirajuća (stvaraju se fistule, neprirodni otvori između crijeva i drugih organa),
English: In these studies Remicade produced a greater improvement in symptoms, led to fistulae healing in more patients and increased the time that patients continued to respond to treatment.
Croatian: U tim ispitivanjima primjenom lijeka Remicade postignut je veći stupanj ublažavanja simptoma, fistule su nestale u većeg broja bolesnika i produljeno je vrijeme tijekom kojega su bolesnici odgovarali na liječenje.
English: In a study in 627 adults with psoriasis, Remicade led to a greater improvement in symptoms than placebo.
Croatian: Tijekom ispitivanja provedenog među 627 odraslih osoba s psorijazom, primjenom lijeka Remicade simptomi su ublaženi u većoj mjeri nego li primjenom placeba.
English: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Croatian: • reumatoidnog artritisa (bolesti imunosnog sustava koja uzrokuje upalu zglobova).
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remicade is used to treat.
Croatian: Taj glasnik sudjeluje u nastanku upale te se u visokim razinama nalazi u osoba oboljelih od bolesti koje se liječe lijekom Remicade.
English: How is Remicade used?
Croatian: Kako se Remicade primjenjuje?
English: In Crohn's disease in adults, Remicade was compared with placebo (a dummy treatment) in 1,090 adults in four studies.
Croatian: Lijek Remicade uspoređen je s placebom (prividno liječenje) u 1 090 odraslih osoba oboljelih od Crohnove bolesti u okviru četiriju ispitivanja.
English: More adult patients receiving Remicade had a reduction in symptoms than those receiving placebo.
Croatian: Ublažavanje simptoma postignuto je u većeg broja odraslih bolesnika koji su primali lijek Remicade nego onih koji su primali placebo.
English: • psoriasis (a disease causing red, scaly patches on the skin).
Croatian: • psorijaze (bolesti koja uzrokuje crvene ljuskave mrlje na koži).
English: All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
Croatian: Tijekom infuzije i najmanje jedan do dva sata nakon nje svi su bolesnici pod nadzorom radi utvrđivanja mogućih reakcija.
English: In these studies, more patients taking Remicade in combination with methotrexate showed a reduction in symptoms than those taking methotrexate alone, as well as less damage to the joints and greater improvements in physical function.
Croatian: U tim su ispitivanjima ublažavanje simptoma bolesti, manje oštećenje zglobova i veće poboljšanje fizičkih funkcija opaženi u više bolesnika koji su primali lijek Remicade u kombinaciji s metotreksatom nego u onih koji su primali samo metotreksat.
English: Remicade contains the active substance infliximab.
Croatian: Remicade sadržava djelatnu tvar infliksimab.
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Croatian: • ankilozantnog spondilitisa (bolesti koja uzrokuje upalu i bol zglobova kralježnice),
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Croatian: • ulceroznog kolitisa (bolesti koja uzrokuje upalu i čireve na stijenci crijeva),
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Croatian: • psorijatičnog artritisa (bolesti koja uzrokuje crvene ljuskave mrlje na koži i upalu zglobova),
English: For the full list of side effects of Remicade, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Remicade potražite u uputi o lijeku.
English: Do not store above 30°C.
Croatian: Nemojte čuvati na temperaturi iznad 30C.
English: Total number of subjects with events, n
Croatian: Ukupan broj ispitanika s događajima, n
English: Component of a 3 bottle multipack, can not be sold separately.
Croatian: Sastavni dio višestrukog pakiranja s 3 boce, ne smije se prodavati odvojeno.
English: 58% of patients were male.
Croatian: 58% bolesnika bili su muškarci.
English: Not known (freqency cannot be estimated from the available data)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: Date of first authorisation: 23 April 2014 Date of latest renewal: 18 December 2018
Croatian: Datum posljednje obnove odobrenja: 18. prosinca 2018.
English: Infections and infestations not known
Croatian: Infekcije i infestacije nepoznato
English: Some patients had more than one amputation.
Croatian: U nekih je bolesnika provedeno više od jedne amputacije.
English: Note: Incidence is based on the number of patients with at least one amputation, and not the total number of amputation events.
Croatian: Napomena: Incidencija se temelji na broju bolesnika s najmanje jednom amputacijom, a ne na ukupnom broju amputacija.
English: However, if it is time for the next dose, skip the missed dose.
Croatian: Međutim, ako je vrijeme za sljedeću dozu, preskočite propuštenu dozu.
English: • about what you can do to prevent dehydration (see section 4 for signs of dehydration).
Croatian: • vezano uz to što možete poduzeti radi sprječavanja dehidracije (pogledajte dio 4 za znakove dehidracije).
English: The mean Vd ranged between 63-276 litres.
Croatian: Srednji Vd bio je u rasponu od 63-276 litara.
English: Vokanamet is not recommended for children and adolescents under 18 years, because data are not available in these patients.
Croatian: Primjena lijeka Vokanamet se ne preporučuje u djece i adolescenata ispod 18 godina, jer nisu dostupni podaci za te bolesnike.
English: P value for superiority (2-sided) = 0.0158.
Croatian: P-vrijednost za superiornost (dvostrana) = 0,0158.
English: 17% of patients were Hispanic.
Croatian: 17% bolesnika bilo je hispano porijekla.
English: „Кораб планина“ № 8 офис 1
Croatian: ТП„Мундифарма медикъл ООД“ ул. „Кораб планина“ № 8 офис 1
English: Constipation, Thirst f, Nausea
Croatian: Konstipacija, žeđ f, mučnina
English: Renal failure h (mainly in the context of volume depletion)
Croatian: Zatajenje bubrega h (većinom u kontekstu deplecije volumena)
English: • common: a metallic taste (taste disturbance)
Croatian: • često: metalni okus (poremećaj okusa)
English: Severe allergic reaction (rare, may affect up to 1 in 1,000 people) Possible signs of severe allergic reaction may include:
Croatian: Teška alergijska reakcija (rijetko, mogu se javiti u do 1 na 1000 osoba) Mogući znakovi teške alergijske reakcije mogu uključivati:
English: Balanitis or balanoposthitis b, l
Croatian: Balanitis ili balanopostitis b,l
English: Vital status was obtained for 99.6% of subjects across the studies.
Croatian: Podaci o vitalnom statusu prikupljeni su u 99,6% ispitanika iz oba ispitivanja.
English: Talk to your doctor about the best way to control your blood sugar without Vokanamet as soon as you know that you are pregnant.
Croatian: Razgovarajte sa svojim liječnikom kako na najbolji način kontrolirati šećer u krvi bez lijeka Vokanamet, čim saznate da ste trudni.
English: Figure 1: Time to first occurrence of MACE
Croatian: Vrijeme do prvog nastupa MACE događaja
English: The mean age was 63 years and 64% were male.
Croatian: Srednja vrijednost dobi iznosila je 63 godine, a 64% ispitanika bili su muškarci.
English: Thereafter, eGFR was maintained or gradually increased during continued treatment.
Croatian: Nakon toga se eGFR održao na istoj razini ili se postupno povećavao s nastavkom liječenja.
English: Each MACE component positively contributed to the overall composite, as shown in Figure 2.
Croatian: Svaka je pojedinačna sastavnica MACE događaja pozitivno pridonijela ukupnoj kompozitnoj mjeri ishoda, što je prikazano na Slici 2.
English: More information is given below in "Other medicines and Vokanamet".
Croatian: Više informacija možete pronaći niže, u dijelu “Drugi lijekovi i Vokanamet”.
English: Rash g, Urticaria rare
Croatian: Osip g, urtikarija rijetko
English: In controlled clinical studies, Cmax did not exceed 5 μg/mL, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima, Cmax nisu prešle 5 μg/ml, čak i pri maksimalnim dozama.
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti su definirane prema sljedećem sporazumu: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Talk to your doctor, pharmacist or nurse before taking Vokanamet, and during treatment:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Vokanamet, te tijekom liječenja:
English: • Swallow the tablet whole with water.
Croatian: • Progutajte tabletu cijelu s vodom.
English: The primary endpoint in the CANVAS Program was the time to first occurrence of a MACE.
Croatian: Primarna mjera ishoda u programu CANVAS bila je vrijeme do prvog nastupa MACE događaja.
English: • if you have type 1 diabetes because Vokanamet should not be used to treat this condition.
Croatian: • ako imate šećernu bolest tipa 1 jer se Vokanamet ne smije uzimati za liječenje ovog stanja.
English: • It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your healthcare professional.
Croatian: • važno je da redovito provjeravate svoja stopala, te da se držite bilo kojeg drugog savjeta vezanog uz njegu stopala i primjerenu hidrataciju kojeg ste dobili od svog zdravstvenog radnika.
English: Dehydration rare
Croatian: Dehidracija rijetko
English: A patient's follow-up is calculated from Day 1 to the first amputation event date.
Croatian: Trajanje praćenja bolesnika računalo se od 1. dana ispitivanja do datuma prve amputacije.
English: Monitoring of ketones is recommended in these patients.
Croatian: Preporučuje se praćenje ketona u ovih bolesnika.
English: Lactic acidosis, Vitamin B12 deficiency
Croatian: Laktacidoza, deficijencija vitamina B12
English: The percentage of minor and major amputations is based on the highest level amputation for each patient.
Croatian: Postotak manjih i većih amputacija temelji se na amputaciji najviše razine u pojedinog bolesnika.
English: Tell your doctor as soon as possible if you have any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people)
Croatian: Što je prije moguće recite svom liječniku ako imate bilo koju od sljedećih nuspojava: Hipoglikemija (vrlo često, može se javiti u više od 1 na 10 osoba)
English: Liver function test abnormal, Hepatitis
Croatian: Abnormalan nalaz testova jetrene funkcije, hepatitis
English: canagliflozin N = 5,790
Croatian: Kanagliflozin N = 5790
English: These studies were multicenter, multi-national, randomised, double-blind, parallel group, with similar inclusion and exclusion criteria and patient populations.
Croatian: To su bila multicentrična, multinacionalna, randomizirana, dvostruko slijepa ispitivanja s paralelnim skupinama, koja su imala slične uključne i isključne kriterije te slične populacije bolesnika.
English: As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown.
Croatian: Budući da nije utvrđen podležeći mehanizam, nisu poznati faktori rizika za amputaciju osim općih faktora rizika.
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Croatian: Odmah prestanite uzimati ovaj lijek i odmah se obratite liječniku ili u najbližu bolnicu (pogledate dio 2).
English: The risk of lower limb amputation was not dose-dependent.
Croatian: Rizik od amputacije donjih ekstremiteta nije ovisio o dozi.
English: Hypotension a, Orthostatic hypotension
Croatian: Hipotenzija a, ortostatska hipotenzija
English: What Vokanamet is and what it is used for What you need to know before you take Vokanamet How to take Vokanamet
Croatian: Što je Vokanamet i za što se koristi Što morate znati prije nego počnete uzimati Vokanamet Kako uzimati Vokanamet