FrancophonIA/ELRC3.0 huggingface dataset:
English: Doctors should review treatment after 3 months and only continue it if patients benefit from it.
Croatian: Liječnici bi trebali preispitati liječenje nakon 3 mjeseca i nastaviti ga isključivo ako bolesnici od njega imaju koristi.
English: Patients can inject the medicine themselves after being trained.
Croatian: Bolesnici si mogu sami ubrizgavati lijek nakon što prođu odgovarajuću obuku za to.
English: What measures are being taken to ensure the safe and effective use of Emgality?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Emgality?
English: It contains the active substance galcanezumab.
Croatian: Sadrži djelatnu tvar galcanezumab.
English: The active substance of Emgality, galcanezumab, is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size.
Croatian: Djelatna tvar lijeka Emgality, galcanezumab, monoklonsko je antitijelo (vrsta proteina) kojemu je namjena vezivanje i blokiranje tvari „CGRP”, pri čemu pomaže krvnim žilama da se vrate u svoju uobičajenu veličinu.
English: The most common side effects with Emgality (which may affect more than 1 in 10 people) are reactions at the site of injection such as pain, redness, itching, bruising or swelling.
Croatian: Najčešće nuspojave lijeka Emgality (koje se mogu pojaviti u više od 1 na 10 osoba) jesu reakcije na mjestu injiciranja, kao što su bol, crvenilo, svrbež, modrice ili oticanje.
English: Treatment should be started with the injection of the content of 2 syringes (or pens), followed a month later by single injections given every month.
Croatian: Liječenje treba započeti ubrizgavanjem sadržaja dviju štrcaljki (ili brizgalica), a mjesec dana nakon toga daju se pojedinačne mjesečne injekcije.
English: Other information about Emgality
Croatian: Ostale informacije o lijeku Emgality
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emgality have 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 Emgality nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Emgality is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Croatian: Emgality je lijek koji se primjenjuje za sprječavanje migrene u odraslih osoba koje imaju migrenu najmanje četiri dana mjesečno.
English: Side effects reported with Emgality are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Emgality pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: A substance called CGRP has been shown to be involved in the development of migraine by widening blood vessels in the brain.
Croatian: Pokazalo se da tvar naziva „CGRP” sudjeluje u nastanku migrene, tako što proširuje krvne žile u mozgu.
English: Emgality can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of migraine.
Croatian: Emgality se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju migrene.
English: The European Medicines Agency therefore decided that Emgality'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 Emgality nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.
Croatian: Emgality se pokazao učinkovitijim od placeba u smanjenju broja dana s migrenom, unatoč tome što je opseg učinkovitosti ograničen, osobito za bolesnike s kroničnom migrenom.
English: As for all medicines, data on the use of Emgality are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Emgality kontinuirano se prate.
English: What is Emgality and what is it used for?
Croatian: Što je Emgality i za što se primjenjuje?
English: Why is Emgality authorised in the EU?
Croatian: Zašto je Emgality odobren u EU-u?
English: In two studies involving 1,784 patients who had migraines between 4 and 14 days a month, those treated with Emgality had 4 or 5 fewer days with migraines per month, compared with 2 to 3 fewer days for patients on a placebo injection.
Croatian: U dvama istraživanjima kojima je obuhvaćeno 1 784 bolesnika koji su imali migrene između 4 i 14 dana mjesečno, oni koji su liječeni lijekom Emgality imali su 4 ili 5 dana s migrenom manje mjesečno, u usporedbi s 2 ili 3 dana manje za bolesnike koji su primali injekcije placeba.
English: What are the risks associated with Emgality?
Croatian: Koji su rizici povezani s lijekom Emgality?
English: An overview of Emgality and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Emgality i zašto je odobren u EU-u
English: For more information about using Emgality, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Emgality pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: In a third study of 1,117 patients who had migraines for more than 15 days a month on average (chronic migraine), those treated with Emgality had on average around 5 fewer days with migraines per month compared with around 3 fewer days for patients on placebo.
Croatian: U drugom ispitivanju kojim je obuhvaćeno 1 117 bolesnika koji su u prosjeku imali migrenu više od 15 dana mjesečno (kronična migrena), bolesnici liječeni lijekom Emgality imali su u prosjeku 5 dana s migrenom manje, u usporedbi s otprilike 3 dana manje u bolesnika koji su primali placebo.
English: Emgality is injected under the skin using a pre-filled syringe or pen.
Croatian: Emgality se ubrizgava supkutano putem napunjene štrcaljke ili brizgalice.
English: Overall, Emgality led to 2 fewer days with migraines per month compared with placebo (a dummy treatment).
Croatian: Općenito gledajući, lijek Emgality uzrokovao je 2 dana s migrenom manje mjesečno u usporedbi s placebom (prividnim liječenjem).
English: How does Emgality work?
Croatian: Kako djeluje Emgality?
English: The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.
Croatian: Smatra se da se nuspojave koje su zabilježene pri primjeni lijeka Emgality mogu kontrolirati, a većinom su blage ili umjerene.
English: What benefits of Emgality have been shown in studies?
Croatian: Koje su koristi od lijeka Emgality utvrđene u ispitivanjima?
English: Emgality was shown to be effective at reducing the number of days patients suffer migraines in 3 main studies.
Croatian: Emgality se u trima ispitivanjima pokazao učinkovitim u smanjenju broja dana tijekom kojih su bolesnici bolovali od migrene.
English: For the full list of side effects and restrictions of Emgality, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Emgality potražite u uputi o lijeku.
English: How is Emgality used?
Croatian: Kako se Emgality primjenjuje?
English: It is given once a day by infusion lasting about one hour.
Croatian: Lijek se daje jedanput dnevno putem infuzije u trajanju od oko jedan sat.
English: The full EPAR for Cancidas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Cancidas nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Cancidas caspofungin
Croatian: Cancidas kaspofungin
English: This summary was last updated in 07-2016.
Croatian: Sažetak je posljednji put ažuriran u 07.2016.
English: The most common side effect in children is fever and this occurs in more than 1 patient in 10.
Croatian: Najčešća nuspojava u djece je vrućica koja se pojavljuje u više od 1 na 10 bolesnika.
English: The name of the medicine was changed to Cancidas on 9 April
Croatian: Naziv lijeka promijenjen je u Cancidas 9. travnja 2003.
English: This is known as ‘empirical treatment', which means that the doctor starts treatment based on an observation of the patient before confirming that the patient has the infection.
Croatian: To je poznato i kao „empirijsko liječenje”, što znači da liječnik započinje liječenje na osnovi promatranja bolesnika prije potvrde da bolesnik ima infekciju.
English: The most common side effects with Cancidas in adults (which may affect up to 1 in 100 people) are reduced levels of haemoglobin or red blood cells, reduced white blood cell count, low levels of potassium in the blood, headache, inflammation of the veins, shortness of breath, nausea, diarrhoea, vomiting, raised levels of liver enzymes and bilirubin (which may indicate liver problems), rash, itching, redness of skin, excessive sweating, joint pain, fever, chills, itching at injection site, and reduced levels of albumin, a protein in the blood.
Croatian: Najčešće nuspojave lijeka Cancidas u odraslih osoba (koje se mogu javiti u do jedne na 100 osoba) smanjene su razine hemoglobina ili crvenih krvnih stanica, smanjen broj bijelih krvnih stanica, niske razine kalija u krvi, glavobolja, upala vena, kratkoća daha, mučnina, proljev, povraćanje, povećane razine jetrenih enzima i bilirubina (što može ukazivati na probleme s jetrom), osip, svrbež, crvenilo kože, pretjerano znojenje, bol u zglobovima, vrućica, zimica, svrbež na mjestu injekcije i smanjene razine albumina, proteina u krvi.
English: Other information about Cancidas
Croatian: Ostale informacije o lijeku Cancidas
English: In patients between 12 months and 17 years of age, the dose is calculated using the child's height and weight.
Croatian: U bolesnika u dobi od 12 mjeseci do 17 godina doza se izračunava prema visini i težini bolesnika).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD on 24 October 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Caspofungin MSD na snazi u Europskoj uniji od 24. listopada 2001.
English: This is a summary of the European public assessment report (EPAR) for Cancidas.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Cancidas.
English: What measures are being taken to ensure the safe and effective use of Cancidas?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cancidas?
English: It is not intended to provide practical advice on how to use Cancidas.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Cancidas.
English: Treatment is continued for up to two weeks after the infection has been cured.
Croatian: Liječenje se nastavlja nakon izlječenja infekcije u trajanju od najviše dva tjedna.
English: What is Cancidas and what is it used for?
Croatian: Što je Cancidas i za što se koristi?
English: Cancidas should be used with care in children below 12 months of age, because it has not been studied sufficiently in this age group.
Croatian: U djece mlađe od 12 mjeseci lijek Cancidas treba koristiti s oprezom jer lijek nije u dovoljnoj mjeri ispitan za tu dobnu skupinu.
English: The Committee therefore recommended that Cancidas be given marketing authorisation.
Croatian: Odbor je stoga preporučio izdavanje odobrenja za stavljanje lijeka Cancidas u promet.
English: Cancidas is an antifungal medicine used to treat the following fungal infections in adults and children:
Croatian: Cancidas je antifungik koji se koristi za liječenje sljedećih gljivičnih infekcija u odraslih osoba i djece:
English: Why is Cancidas approved?
Croatian: Zašto je Cancidas odobren?
English: It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to continue living and growing.
Croatian: Djeluje tako da ometa stvaranje sastavnice stanične stijenke gljivice koja se naziva „polisaharid glukan” i koja je potrebna za opstanak i rast gljivice.
English: Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and unable to grow.
Croatian: Stanice gljivice koje se liječe lijekom Cancidas imaju nepotpuno razvijene ili oštećene stanične stijenke što ih čini krhkima i onemogućuje njihov rast.
English: Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Croatian: Liječenje lijekom Cancidas treba započeti liječnik koji ima iskustva u liječenju invazivnih gljivičnih infekcija.
English: • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is feverish and has low white blood cell counts.
Croatian: • sumnja na gljivične infekcije (uzrokovane gljivicama kao što su Candida ili Aspergillus) u slučaju kada je bolesnik febrilan (ima groznicu) i ima nisku razinu bijelih krvnih stanica.
English: • invasive aspergillosis (an infection caused by Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines);
Croatian: • invazivna aspergiloza (infekcija koju uzrokuje gljivica Aspergillus) u bolesnika u kojih je izostao odgovor na liječenje ili koji ne podnose amfotericin B ili itrakonazol (druge antifungalne lijekove);
English: In adults, treatment starts with a 70 mg on the first day, followed by a daily dose of 50 mg, or 70 mg if the patient weighs more than 80 kg. A lower dose may be necessary in adults who have moderate problems with their liver.
Croatian: U odraslih, liječenje se započinje početnom dozom od 70 mg prvog dana, a nastavlja se dnevnom dozom od 50 mg ili 70 mg ako bolesnik ima više od 80 kg.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cancidas have 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 Cancidas nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Croatian: Djelatna tvar u lijeku Cancidas, kaspofungin, pripada skupini antifungalnih lijekova poznatih pod nazivom „ehinokandini”.
English: Studies show that Cancidas treatment can lead to favourable responses in patients with fungal infections, including improvement of symptoms and the clearing of fungus from patient's body.
Croatian: Ispitivanja su pokazala da primjena lijeka Cancidas može dovesti do povoljnog odgovora na liječenje u bolesnika s gljivičnim infekcijama, uključujući poboljšanje simptoma i nestanak gljivica iz tijela bolesnika.
English: The CHMP decided that evidence form the studies with Cancidas show that the medicines benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and for empirical therapy for presumed fungal infections, in adults or children.
Croatian: CHMP je zaključio da ispitivanja lijeka Cancidas dokazuju da koristi lijeka nadmašuju s njim povezane rizike u liječenju invazivne kandidijaze ili aspergiloze i empirijskom liječenju pretpostavljenih gljivičnih infekcija u odraslih osoba ili djece.
English: What are the risks associated with Cancidas?
Croatian: Koji su rizici povezani s lijekom Cancidas?
English: Similar responses were seen in a study in 49 children and adolescents with either invasive candidiasis or invasive aspergillosis: 50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas.
Croatian: Slični odgovori zabilježeni su u ispitivanju na 49 djece i adolescenata s invazivnom kandidijazom ili invazivnom aspergilozom: 50 % ispitanika s invazivnom kandidijazom (5 od 10) i 81 % ispitanika s invazivnom aspergilozom (30 od 37) odgovorilo je pozitivno na lijek Cancidas.
English: Cancidas is a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Cancidas je prašak od kojeg se priprema otopina za intravensku infuziju (drip).
English: For more information about treatment with Cancidas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Cancidas pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10).
Croatian: Među bolesnicima koji nisu tolerirali druge terapije, njih 70 % odgovorilo je pozitivno na lijek Cancidas (7 od 10).
English: ‘Invasive' means that the infection has spread into the blood;
Croatian: • invazivna kandidijaza (infekcija koju uzrokuje gljivica Candida). „Invazivna” znači da se infekcija proširila u krvotok;
English: In a study of 239 adults with invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115).
Croatian: U ispitivanju provedenom na 239 odraslih bolesnika s invazivnom kandidijazom, u 73 % odraslih ispitanika koji su primali lijek Cancidas odgovor na lijek ocijenjen je kao povoljan (80 od 109), u usporedbi sa 62 % odraslih ispitanika koji su primali amfotericin B (71 od 115).
English: For the full list of all side effects reported with Cancidas in adults and children, see the Package Leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Cancidas u odraslih osoba i djece potražite u uputi o lijeku.
English: The list of fungi against which Cancidas is active can be found in the summary of product characteristics (also part of the EPAR).
Croatian: Popis gljivica protiv kojih je lijek Cancidas aktivan dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: What benefits of Cancidas have been shown in studies?
Croatian: Koje su koristi lijeka Cancidas utvrđene u ispitivanjima?
English: How does Cancidas work?
Croatian: Kako djeluje Cancidas?
English: In an invasive aspergillosis study involving 69 adults, 41% had a favourable response to Cancidas at the end of the study (26 out of 63).
Croatian: U ispitivanju na bolesnicima s invazivnom aspergilozom koje je provedeno na 69 odraslih osoba, 41 % ispitanika imalo je povoljan odgovor na lijek Cancidas na kraju ispitivanja (26 od 63).
English: For practical information about using Cancidas, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Cancidas pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53).
Croatian: Od odraslih ispitanika u kojih je izostao odgovor na druga liječenja, njih 36 % odgovorilo je pozitivno na lijek Cancidas (19 od 53).
English: How is Cancidas used?
Croatian: Kako se Cancidas koristi?
English: Cancidas contains the active substance caspofungin
Croatian: Lijek Cancidas sadrži djelatnu tvar kaspofungin.
English: Finally, in 2 studies of patients with suspected fungal infection who were treated empirically, Cancidas was as effective as amphotericin B. In one of studies involving around 1,000 adults, 34% of patients had a favourable response with either Cancidas or amphotericin B Similar results were seen in the second study, which involved 82 children aged between two and 17 years.
Croatian: Konačno, u dvama ispitivanjima na bolesnicima s pretpostavljenom gljivičnom infekcijom koji su liječeni empirijski, lijek Cancidas bio je djelotvoran koliko i amfotericin B.
English: Do not take for more than 3 days.
Croatian: Nemojte uzimati dulje od 3 dana.
English: • are under 18 years Talk to a pharmacist or your doctor before taking if you:
Croatian: • imate manje od 18 godina Obratite se ljekarniku ili svom liječniku prije uzimanja ako:
English: • Macrogol/PEG-4000
Croatian: • Makrogol/PEG-4000
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno, u suradnji s referentnom državom članicom, u skladu s postupcima navedenim u Poglavlju 4 Glave III Direktive 2001/83/EZ.
English: The active substance ibuprofen shows an environmental risk for the aquatic environment especially to fish.
Croatian: Djelatna tvar ibuprofen predstavlja rizik za vodeni okoliš, osobito za ribe.
English: The valid product information is the final version achieved during the Coordination group procedure with the following amendments (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below:
Croatian: Valjane informacije o lijeku konačna su verzija postignuta u postupku Koordinacijske grupe uz sljedeće izmjene i dopune (umetanje, zamjenu ili brisanje teksta kako je odgovarajuće) kako bi se odrazio dogovoreni tekst naveden u nastavku:
English: Dose reduction is recommended in patients showing signs of worsening hepatic function.
Croatian: Smanjenje doze preporučuje se kod bolesnika koji pokazuju znakove pogoršanja funkcije jetre.
English: The exact mechanism of action of ibuprofen is thought to be through peripheral inhibition of cyclooxygenases and subsequent prostaglandin synthesise inhibition.
Croatian: Smatra se da se točan mehanizam djelovanja ibuprofena odvija preko periferne inhibicije ciklooksigenaza i naknadne inhibicije sinteze prostaglandina.
English: [The following wording should be amended as follows] This medicinal product should not be taken with other medicinal products containing paracetamol, ibuprofen, acetylsalicylic acid, salicylates or with any other anti-inflammatory drugs (NSAIDs) unless under a doctor's instruction.
Croatian: [Tekst u nastavku potrebno je izmijeniti kako slijedi] Ovaj lijek se ne smije uzimati s drugim lijekovima koji sadrže paracetamol, ibuprofen, acetilsalicilatnu kiselinu, salicilate niti s bilo kojim drugim protuupalnim lijekovima (NSAIL-ovima) osim po uputama liječnika.
English: [The following wording should be amended as follows] If your symptoms do not get better after 3 days, if they get worse or if you get new symptoms, talk to your doctor.
Croatian: Ako se Vaši simptomi ne poboljšaju nakon 3 dana, ako se pogoršaju ili dobijete nove simptome, obratite se svom liječniku.
English: Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section]
Croatian: Dio 4.4 Posebna upozorenja i mjere opreza pri uporabi [Sljedeću rečenicu potrebno je umetnuti u ovaj dio]
English: Children under18 years: [The following wording should be amended as follows] This product is not recommended forDo not give to children under 18 years.
Croatian: Djeca mlađa od 18 godina: [Sljedeći tekst potrebno je izmijeniti kako slijedi] Ovaj lijek se ne preporučuje za Ne davati djeci mlađoj od 18 godina.
English: [The following AEs are described as follows:] ‘Paraesthesia' to frequency Rare (moved from Very Rare) ‘Oedema' to frequency Common (moved from Very Rare)
Croatian: [Sljedeće nuspojave opisane su kako slijedi:] ‘Parestezija' pod učestalosti Rijetko (prebačeno s Vrlo rijetko) ‘Edem' pod učestalosti Često (prebačeno s Vrlo rijetko)
English: Treatment should be stopped in those patients who develop severe liver failure (see section 4.3).
Croatian: Liječenje se mora zaustaviti kod bolesnika koji razviju teško zatajenje jetre (vidjeti dio 4.3).
English: Amendments to the relevant sections of the product information
Croatian: Izmjene i dopune odgovarajućih dijelova informacija o lijeku