FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients may need to take Daliresp for several weeks before it starts to have an effect.
Croatian: Bolesnici će ponekad morati uzimati Daliresp nekoliko tjedana prije nego što on počne djelovati.
English: By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient's symptoms or to prevent them from getting worse.
Croatian: Blokiranjem djelovanja PDE4 roflumilast smanjuje upalu u plućima i time pomaže ublažiti simptome bolesnika ili spriječiti njihovo pogoršanje.
English: What measures are being taken to ensure the safe and effective use of Daliresp?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Daliresp?
English: The doctor may stop treatment with Daliresp if the patient loses too much weight.
Croatian: Liječnik može zaustaviti liječenje Dalirespom ako bolesnik izgubi previše tjelesne težine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Daliresp on 28 February 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Daliresp na snazi u Europskoj uniji od 28. veljače 2011. godine.
English: At the beginning of the study, both groups of patients had an FEV1 of around 1 litre (1,000 ml).
Croatian: Na početku ispitivanja obje su skupine bolesnika imale FEV1 oko 1 litre (1000 ml).
English: The patients could continue to receive treatment with a bronchodilator during the study.
Croatian: Bolesnici su za vrijeme ispitivanja mogli nastaviti s liječenjem bronhodilatatorom.
English: Daliresp was shown to be more effective than placebo at treating COPD.
Croatian: Daliresp se pokazao djelotvornijim od placeba u liječenju KOPB-a.
English: This is a summary of the European public assessment report (EPAR) for Daliresp.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Daliresp.
English: This benefit was seen on top of the effects of the treatments that the patients were already receiving.
Croatian: Ta se korist smatrala dodatkom liječenjima kojima su bolesnici već bili podvrgnuti.
English: The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment.
Croatian: Glavna mjera djelotvornosti bio je napredak u odnosu na forsirani ekspiratorni volumen (FEV1) i smanjenje broja umjerenih ili teških izbijanja njihovog KOPB-a tijekom godine liječenja.
English: In addition, the company that makes Daliresp will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Croatian: Osim toga, proizvođač Dalirespa osigurat će da zdravstveni djelatnici koji će propisivati lijek u svim državama članicama Europske unije (EU) dobiju edukacijski paket koji sadržava informacije o nuspojavama lijeka i kako ga treba koristiti.
English: The most common side effects with Daliresp (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Croatian: Najčešće nuspojave lijeka Daliresp (primijećene kod 1 - 10 bolesnika od njih 100) jesu smanjenje težine, smanjenje teka, nesanica (poteškoće sa spavanjem), glavobolja, proljev, mučnina (osjećaj slabosti) i bol u trbuhu.
English: After a year, the patients who took Daliresp had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Croatian: Nakon godine dana kod bolesnika koji su uzimali Daliresp zabilježeno je prosječno povećanje od 40 ml, dok je kod onih koji su uzimali placebo prosječno smanjenje iznosilo 9 ml.
English: For more information about treatment with Daliresp, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Daliresp pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD.
Croatian: On blokira djelovanje enzima PDE4 prisutnog u upalnom procesu koji dovodi do KOPB-a.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Croatian: KOBP je dugotrajna bolest kod koje su dišni putevi i zračne vrećice unutar pluća oštećene ili blokirane što uzrokuje otežano udisanje ili izdisanje zraka iz pluća.
English: After considering all of the available data on the effects of the medicine, the Committee decided that Daliresp's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Nakon razmatranja svih dostupnih podataka o učincima lijeka Odbor je odlučio da koristi Dalirespa nadmašuju s njim povezane rizike i preporučio je izdavanje odobrenja za njegovo stavljanje u promet.
English: A risk management plan has been developed to ensure that Daliresp is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena Dalirespa.
English: The active substance in Daliresp, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Croatian: Roflumilast, djelatna tvar u Dalirespu, pripada skupini lijekova zvanih inhibitori fosfodiesteraze tipa 4 (PDE4).
English: Other information about Daliresp
Croatian: Ostale informacije o lijeku Daliresp
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Daliresp.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Daliresp.
English: Daliresp is a medicine that contains the active substance roflumilast.
Croatian: Daliresp je lijek koji sadrži djelatnu tvar roflumilast.
English: In addition, the patients who took Daliresp had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Croatian: Osim toga, kod bolesnika koji su uzimali Daliresp u prosjeku je zabilježeno 1,1 umjereno ili teško izbijanje njihove bolesti u usporedbi s prosjekom izbijanja od 1,4 kod bolesnika koji su uzimali placebo.
English: The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Daliresp is appropriate for them.
Croatian: Proizvođač lijeka također će osigurati kartice za bolesnike na kojima je navedeno što moraju reći liječniku o svojim simptomima i povijesti bolesti kako bi liječnik mogao znati je li Daliresp odgovarajući lijek za njih.
English: Because patients taking Daliresp may lose weight, they are advised to weigh themselves on a regular basis.
Croatian: S obzirom na to da je kod bolesnika koji uzimaju Daliresp moguć gubitak tjelesne težine, savjetuje im se da se redovito važu.
English: Daliresp is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Croatian: Daliresp se ne koristi kao samostalni lijek nego kao dodatak liječenju bronhodilatatorima (lijekovima koji šire dišne puteve u plućima).
English: Daliresp has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Croatian: Daliresp je uspoređen s placebom (lažno liječenje) u dva glavna ispitivanja koja su obuhvatila više od 3000 odraslih osoba s teškim KOPB-om kojima se bolest pogoršala barem jedanput tijekom prošle godine.
English: Why has Daliresp been approved?
Croatian: Zašto je Daliresp odobren?
English: What is the risk associated with Daliresp?
Croatian: Koji su rizici povezani s lijekom Daliresp?
English: Daliresp is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Croatian: Daliresp se koristi za liječenje teške kronične opstruktivne plućne bolesti (KOPB) kod odraslih osoba koje imaju kronični bronhitis (dugotrajnu upalu dišnih puteva) i kod kojih se KOPB često pogoršava.
English: What is Daliresp?
Croatian: Što je Daliresp?
English: The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daliresp in patients with severe COPD.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) istaknuo je potrebu za novim načinima liječenja KOPB-a i da su glavna ispitivanja pokazala umjerenu korist Dalirespa kod bolesnika s teškim KOPB-om.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Daliresp, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetku opisa svojstava lijeka, kao i u uputi o lijeku za Daliresp, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is Daliresp used for?
Croatian: Za što se Daliresp koristi?
English: How does Daliresp work?
Croatian: Kako djeluje Daliresp?
English: What benefit has Daliresp shown during the studies?
Croatian: Koje su koristi lijeka Daliresp utvrđene u ispitivanjima?
English: How is Daliresp used?
Croatian: Kako se Daliresp koristi?
English: How has Daliresp been studied?
Croatian: Kako je Daliresp ispitivan?
English: Daliresp must not be used in patients who have moderate or severe problems with their liver.
Croatian: Bolesnici koji imaju umjerene ili teške tegobe s jetrom ne smiju uzimati Daliresp.
English: For the full list of all side effects reported with Daliresp, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Daliresp potražite u uputi o lijeku.
English: Further information on Braftovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Braftovi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Braftovi (encorafenib)
Croatian: Braftovi (enkorafenib)
English: These side effects occurred in more than 1 in 4 patients.
Croatian: Ozbiljne nuspojave javljaju se u više od 1 na 4 bolesnika.
English: Braftovi is available as capsules (50 mg and 75 mg).
Croatian: Lijek Braftovi dostupan je u obliku kapsula (50 mg i 75 mg).
English: Braftovi (encorafenib) EMA/570410/2018
Croatian: Braftovi (enkorafenib) EMA/570410/2018
English: Patients normally take 450 mg (six 75 mg capsules) once a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Croatian: Bolesnici obično uzimaju 450 mg (šest kapsula od 75 mg) jednom dnevno, ali se doza može smanjiti ili privremeno prekinuti liječenje ako dođe do problematičnih nuspojava.
English: Patients who took this combination lived on average for nearly 15 months without the disease getting worse.
Croatian: Bolesnici koji su primali tu kombinaciju lijekova živjeli su u prosjeku 15 mjeseci bez pogoršanja bolesti.
English: What measures are being taken to ensure the safe and effective use of Braftovi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Braftovi?
English: This encourages cancers to develop by allowing uncontrolled division of cells.
Croatian: To potiče razvoj raka time što dopušta nekontroliranu diobu stanica.
English: What is Braftovi and what is it used for?
Croatian: Što je Braftovi i za što se koristi?
English: For more information about using Braftovi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Braftovi pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Braftovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Croatian: Braftovi je lijek za liječenje melanoma (raka kože) koji se proširio i ne može se odstraniti kirurškim zahvatom.
English: Treatment with Braftovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.
Croatian: Liječenje lijekom Braftovi može trajati sve dok bolesnik ima koristi od njega te nema neprihvatljive nuspojave.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Braftovi 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 Braftovi nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Why is Braftovi authorised in the EU?
Croatian: Zašto je lijek Braftovi odobren u EU-u?
English: The dose of the other medicine, binimetinib, may also be reduced but if binimetinib is stopped Braftovi must be stopped too.
Croatian: Doza drugog lijeka, binimetiniba, također se može smanjiti, ali ako se primjena binimetiniba prekine, potrebno je prekinuti i primjenu lijeka Braftovi.
English: Braftovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines.
Croatian: Braftovi se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u propisivanju lijekova protiv raka.
English: The most common side effects with Braftovi and binimetinib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Croatian: Najčešće nuspojave lijekova Braftovi i binimetinib kada se uzimaju zajedno u najvećoj dopuštenoj dozi su umor, mučnina, proljev, povraćanje, retinalno odvajanje (problem oka koji dovodi do slabog vida), bol u trbuhu, bol u zglobovima, bol u mišićima i visoke razine enzima zvanog kreatin-kinaza, što može ukazivati na probleme s mišićima.
English: As for all medicines, data on the use of Braftovi are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Braftovi kontinuirano se prate.
English: Side effects reported with Braftovi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Braftovi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Braftovi
Croatian: Ostale informacije o lijeku Braftovi
English: Up to 50% of patients with metastatic melanoma have a mutation in BRAF with the V600 mutation being the most common.
Croatian: Do 50 % bolesnika s metastatskim melanomom ima mutaciju BRAF-a, pri čemu je mutacija V600 najčešća.
English: It contains the active substance encorafenib.
Croatian: Sadrži djelatnu tvar enkorafenib.
English: What are the risks associated with Braftovi?
Croatian: Koji su rizici povezani s lijekom Braftovi?
English: Braftovi is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Croatian: Braftovi se koristi u kombinaciji s drugim lijekom, binimetinibom (Mektovi), te je namijenjen samo bolesnicima čije stanice raka imaju određenu mutaciju (promjenu) u genima naziva „BRAF V600”.
English: An overview of Braftovi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Braftovi i zašto je odobren u EU-u
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Braftovi with binimetinib can prolong the length of time patients lived without their disease getting worse.
Croatian: Ispitivanje u kojem je sudjelovalo 577 osoba oboljelih od melanoma s mutacijom BRAF V600 koji se proširio ili se ne može kirurški odstraniti pokazalo je da lijek Braftovi u kombinaciji s binimetinibom može produljiti preživljenje bolesnika bez pogoršanja bolesti.
English: The European Medicines Agency therefore decided that Braftovi'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 lijeka Braftovi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Croatian: U slučaju melanoma s mutacijom BRAF V600 prisutan je abnormalan oblik proteina BRAF, koji aktivira drugi protein naziva MEK uključen u stimulaciju diobe stanica.
English: Braftovi in combination with binimetinib can help prolong the time that these patients live without their disease getting worse.
Croatian: Braftovi u kombinaciji s binimetinibom može pomoći produljiti preživljenje bolesnika bez pogoršanja bolesti.
English: The side effects seen with Braftovi are similar to those seen with other medicines in the same class and are considered manageable.
Croatian: Nuspojave lijeka Braftovi slične su nuspojavama zabilježenima nakon primjene lijekova iz istog razreda te se smatraju prihvatljivima.
English: This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.
Croatian: Usporedbe radi, bolesnici koji su uzimali samo enkorafenib preživjeli su približno 9,5 mjeseci, a bolesnici koji su uzimali drugi lijek pod nazivom vemurafenib preživjeli su malo više od 7 mjeseci.
English: How is Braftovi used?
Croatian: Kako se Braftovi koristi?
English: For the full list of side effects and restrictions, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja potražite u uputi o lijeku.
English: How does Braftovi work?
Croatian: Kako djeluje Braftovi?
English: What benefits of Braftovi have been shown in studies?
Croatian: Koje su koristi od lijeka Braftovi utvrđene u ispitivanjima?
English: The active substance in Braftovi, encorafenib, works by blocking the BRAF protein thereby stopping its activation by MEK and slowing down the growth and spread of the cancer.
Croatian: Djelatna tvar u lijeku Braftovi je enkorafenib koji djeluje tako da inhibira protein BRAF i sprječava da ga MEK aktivira.
English: Lot {number}
Croatian: Lot {broj}
English: ATCvet code: QC09BA07.
Croatian: ATCvet kod: QC09BA07.
English: These measures should help to protect the environment.
Croatian: Te mjere pomažu zaštiti okoliša.
English: Vomiting has been reported very rarely in spontaneous reports.
Croatian: Povraćanje je vrlo rijetko prijavljeno u spontanim izvješćima.
English: Food increases the bioavailability to 80 to 90%.
Croatian: Hrana povećava bioraspoloživost na 80 do 90%.
English: The tablets can be divided into equal halves.
Croatian: Tablete se mogu podijeliti na dvije jednake polovice.
English: Très le Bois
Croatian: Tres le Bois
English: Bodyweight (kg) of dog
Croatian: Tjelesna težina (kg) psa
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: This veterinary medicinal product does not require any special storage conditions.
Croatian: Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvjete čuvanja.
English: Date of first authorisation: 23/07/2012 Date of latest renewal:
Croatian: Datum prvog odobrenja: 23/07/2012
English: EXP {month/year}
Croatian: ROK VALJANOSTI EXP {mjesec/godina}
English: It also allowed a quicker improvement of cough and activity and a slower degradation of cough, heart sounds and appetite.
Croatian: Također je omogućio brže poboljšanje kašlja i aktivnosti kao i sporiju degradaciju kašlja, zvukova srca i apetita.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine.
English: 22600 Loudéac
Croatian: 22600 Loudeac
English: Overdose (symptoms, emergency procedures, antidotes)
Croatian: Predoziranje (simptomi, hitni postupci, antidoti)
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara ili ljekarnika kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
English: Wash hands after use.
Croatian: Nakon primjene proizvoda operite ruke.
English: Keep out of the sight and reach of children.
Croatian: Čuvati izvan pogleda i dosega djece.
English: Pregnancy and lactation
Croatian: Graviditet i laktacija
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
English: Steady-state conditions are reached by day 2.
Croatian: Ravnotežni uvjeti postižu se do drugog dana.
English: This is thought to be due to activation of feedback mechanisms without adverse clinical consequence.
Croatian: To je vjerojatno zbog aktivacije povratnih mehanizama bez štetnih kliničkih posljedica.
English: Do not use in dogs intended or used for breeding.
Croatian: Ne primjenjivati u pasa koji su namijenjeni za razmnožavanje.
English: Do not use during pregnancy and lactation (see section 4.7).
Croatian: Ne primjenjivati tijekom graviditeta i laktacije (vidjeti dio 4.7).
English: The result is an improvement in heart function.
Croatian: Rezultat je poboljšanje srčane funkcije.
English: This hypertrophy does not seem to be linked to any pathology and was observed to be reversible upon discontinuation of the treatment.
Croatian: Ne čini se da je ova hipertrofija povezana s bilo kojim patološkim stanjem te se pokazala reverzibilnom nakon prekida liječenja.
English: Tres le Bois 22600 Loudeac France
Croatian: Tres le Bois 22600 Loudeac Francuska
English: In case of the accidental ingestion by a dog of many Cardalis chewable tablets, there is no specific antidote or treatment.
Croatian: Ako pas slučajno proguta puno tableta za žvakanje Cardalis, ne postoji specifični antidot ili liječenje.
English: The bottles are fitted with childproof caps.
Croatian: Boce su opremljene sa sigurnosnim zatvaračima za djecu.
English: This fixed combination product should only be used in dogs which require both active substances to be administered concomitantly at this fixed dose.
Croatian: Fiksnu kombinaciju proizvoda treba koristiti samo u pasa koji zahtijevaju istovremenu primjenu obje djelatne tvari pri ovoj fiksnoj dozi.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 30 tableta
English: The product causes a long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80%) persisting 24 hours after dosing.
Croatian: Proizvod uzrokuje dugotrajnu inhibiciju plazmatske aktivnosti ACE u pasa s više od 95% inhibicije na vrhuncu učinka i značajnom aktivnosti (> 80%) koja traje 24 sata nakon doziranja.