FrancophonIA/ELRC3.0 huggingface dataset:
English: Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Croatian: Jedna primijenjena doza (doza koja izlazi iz nastavka za usta inhalatora Spiromax) sadrži 320 mikrograma budezonida i 9 mikrograma formoterolfumarat dihidrata.
English: Package leaflet: Information for the patient BiResp Spiromax 320 micrograms/9 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Croatian: Uputa o lijeku: Informacije za bolesnika BiResp Spiromax 320 mikrograma/9 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
English: 160/4.5 µg bd + formoterol 4.5 µg as needed
Croatian: µg dvaput dnevno + formoterol 4,5 µg po potrebi
English: Package leaflet: Information for the patient BiResp Spiromax 160 micrograms/4.5 micrograms, inhalation powder budesonide/formoterol fumarate dihydrate
Croatian: Uputa o lijeku: Informacije za bolesnika BiResp Spiromax 160 mikrograma/4,5 mikrograma, prašak inhalata budezonid/ formoterolfumarat dihidrat
English: 6.3 Shelf life
Croatian: 6.1 Popis pomoćnih tvari laktoza hidrat
English: If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests.
Croatian: Vaš liječnik će možda zatražiti da redovito obavljate krvne pretrage.
English: This is equivalent to a metered dose of 400 micrograms budesonide and 12 micrograms of formoterol fumarate dihydrate.
Croatian: To odgovara odmjerenoj dozi od 400 mikrograma budezonida i 12 mikrograma formoterolfumarat dihidrata.
English: BiResp Spiromax is indicated for use in adults 18 years of age and older only.
Croatian: Primjena lijeka BiResp Spiromax indicirana je samo za odrasle u dobi od 18 i više godina.
English: 160/4.5 µg bd + terbutaline 0.4 mg as needed a
Croatian: µg dvaput dnevno + terbutalin 0,4 mg po potrebi a
English: BiResp Spiromax pharmacokinetic profile
Croatian: Farmakokinetički profil lijeka BiResp Spiromax
English: Patients should be advised to always have BiResp Spiromax available for rescue use.
Croatian: Bolesnike se mora savjetovati da uvijek imaju dostupan
English: BiResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Croatian: BiResp Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Croatian: BiResp Spiromax 320 mikrograma/9 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat Za inhaliranje.
English: What you need to know before you use BiResp Spiromax Do not use BiResp Spiromax if:
Croatian: Nemojte primjenjivati BiResp Spiromax ako:
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze,
English: For BiResp Spiromax there are two treatment approaches:
Croatian: Dva su pristupa liječenju lijekom BiResp Spiromax:
English: The effects include: changes in bone mineral density (thinning of the bones) cataract (clouding of the lens in the eye) glaucoma (increased pressure in the eye) a slowing of the rate of growth of children and adolescents an effect on the adrenal gland (a small gland next to the kidney).
Croatian: • usporavanje brzine rasta u djece i adolescenata • učinak na nadbubrežnu žlijezdu (malu žlijezdu smještenu neposredno pokraj bubrega).
English: If any of the above applies to you, or if you are not sure, talk to your doctor,pharmacist or nurse before using BiResp Spiromax.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas ili niste sigurni, prije uporabe lijeka BiResp
English: BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use.
Croatian: BiResp Spiromax 160 mikrograma/4,5 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat Za inhaliranje.
English: 3 inhalers each containing 60 doses.
Croatian: 2 inhalatora, svaki sadrži 60 doza 3 inhalatora, svaki sadrži 60 doza
English: BiResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Croatian: BiResp Spiromax je indiciran u redovitom liječenju astme kad je primjereno kombinirano liječenje (inhalacijskim kortikosteroidom i dugodjelujućim agonistima ß2-adrenergičkih receptora): -u bolesnika u kojih astma nije zadovoljavajuće kontrolirana inhalacijskim kortikosteroidima i „prema potrebi“ inhalacijskim kratkodjelujućim agonistima ß2-adrenergičkih receptora.
English: Inhalation powder 1 inhaler containing 60 doses.
Croatian: 1 inhalator sadrži 60 doza.
English: Adults (18 years and older): 2 inhalations twice daily
Croatian: Odrasli (s 18 godina i stariji): 2 inhalacije dvaput dnevno Posebne populacije:
English: In 2 other studies with patients seeking medical attention due to acute asthma symptoms, budesonide/formoterol provided rapid and effective relief of bronchoconstriction similar to salbutamol and formoterol.
Croatian: budezonid/formoterol omogućio je brzo i učinkovito ublažavanje bronhokonstrikcije slično salbutamolu i formoterolu.
English: Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Croatian: Mogući sistemski učinci uključuju Cushingov sindrom, Cushingoidna obilježja, adrenalnu supresiju,
English: If you stop using BiResp SpiromaxDo not stop using your inhaler without telling your doctor first.
Croatian: Nemojte prekinuti s primjenom inhalatora bez prethodnog javljanja liječniku.
English: BiResp Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Croatian: BiResp Spiromax 160 μg/4,5 μg prašak inhalata budezonid/formoterolfumarat dihidrat
English: BiResp Spiromax maintenance therapy
Croatian: Terapija održavanja lijekom BiResp Spiromax
English: Using BiResp Spiromax and a separate ‘reliever inhaler'.
Croatian: pročitajte odjeljak pod naslovom (A) Primjena lijeka BiResp Spiromax i zasebnog 'inhalatora za brzo ublažavanje simptoma'.
English: • If you have been prescribed BiResp Spiromax and a separate reliever inhaler, read the section called (A)
Croatian: • Ako Vam je propisan BiResp Spiromax i zaseban inhalator za brzo ublažavanje simptoma,
English: Budesonide/Formoterol Furmarate Dihydrate 320/9
Croatian: Budezonid/formoterol fumaratdihidrat 160/4,5
English: EU/1/15/1047/001 BLINCYTO
Croatian: EU/1/15/1047/001
English: Powder: 38.5 mcg Solution: 10 mL
Croatian: Prašak: 38,5 mcg Otopina: 10 ml
English: 38.5 mcg Powder for concentrate and solution for solution for infusion
Croatian: BLINCYTO 38,5 mcg Prašak za koncentrat i otopina za otopinu za infuziju
English: Intravenous use Powder: vial (glass)
Croatian: Intravenska primjena Prašak: bočica (staklo)
English: 1 vial (powder) + 1 vial (solution)
Croatian: 1 bočica (prašak) + bočica (otopina)
English: The areas harmonised include:
Croatian: Usklađena područja obuhvaćaju:
English: The European Commission issued a decision on this opinion on 08/05/2017.
Croatian: Europska komisija objavila je odluku o tom mišljenju 8.5.2017.
English: The companies that market these medicines include Bayer GmbH and Lundbeck A/S.
Croatian: Tvrtke koje stavljaju u promet ove lijekove uključuju Bayer GmbH i Lundbeck A/S.
English: What is Saroten?
Croatian: Što je Saroten?
English: Use is not permitted in children less than 6 years of age.
Croatian: Nije dopuštena primjena u djece mlađe od 6 godina.
English: Saroten and associated names (such as Redomex and Sarotex) is marketed in Austria, Belgium, Cyprus, Denmark, Estonia, Germany, Greece, Luxembourg, the Netherlands and Sweden, and also in Norway.
Croatian: Saroten i povezani nazivi (kao što su Redomex i Sarotex) stavljeni su u promet u Austriji, Belgiji, Cipru, Danskoj, Estoniji, Njemačkoj, Grčkoj, Luksemburgu, Nizozemskoj i Švedskoj, te u Norveškoj.
English: The medicine should not be given to children to treat depression or pain.
Croatian: Lijek se ne smije davati djeci za liječenje depresije ili boli.
English: Why was Saroten reviewed?
Croatian: Zašto je Saroten ponovno ocjenjivan?
English: Other amendments included the information on interactions with other medicines (4.5), and the list of side effects (4.8).
Croatian: Druge izmjene uključuju informacije o interakcijama s drugim lijekovima (4.5.) i popis nuspojava (4.8.).
English: Saroten is authorised in the EU via national procedures.
Croatian: Saroten je u zemljama EU-a odobren nacionalnim postupcima.
English: The CHMP harmonised the doses to be used in the approved indications.
Croatian: CHMP je uskladio doze koje treba primjenjivati za odobrene indikacije.
English: Questions and answers on Saroten and associated names (amitriptyline)
Croatian: Pitanja i odgovori o lijeku Saroten i povezanim nazivima (amitriptilin)
English: • the treatment of serious depression (major depressive disorder)
Croatian: • liječenje ozbiljne depresije (ozbiljan depresivni poremećaj)
English: 4.1 Therapeutic indications The CHMP agreed that Saroten and associated names could be used in adults for:
Croatian: 4.1 Terapijske indikacije CHMP se složio da se Saroten i povezani nazivi mogu primjenjivati u odraslih za:
English: Amitriptyline is also available in EU countries as generic amitriptyline.
Croatian: Amitriptilin je dostupan u zemljama EU-a i kao generički amitriptilin.
English: It contains the active substance amitriptyline.
Croatian: Sadrži djelatnu tvar amitriptilin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for amitriptyline in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključilo je da postoji potreba za usklađivanjem informacija za propisivanje amitriptilina u Europskoj uniji (EU).
English: • the treatment of neuropathic pain (long-lasting pain caused by nerve damage)
Croatian: • liječenje neuropatske boli (dugotrajna bol prouzročena oštećenjem živca)
English: It must also not be used in patients who have recently had a heart attack or have disorders of the electrical activity or rhythm of the heart or reduced blood flow to the heart muscle, nor in those with severe liver disease.
Croatian: Također se ne smije primjenjivati u bolesnika koji su nedavno imali srčani udar ili imaju poremećaj električne aktivnosti srca ili srčanog ritma, odnosno ako imaju smanjeni dotok krvi u srčani mišić, ili ako imaju ozbiljnu bolest jetre.
English: Treatment for depression or chronic pain may take 2 to 4 weeks to start to work, and treatment for depression should be continued for up to 6 months after the patient gets better.
Croatian: U liječenju depresije ili kronične boli može biti potrebno 2 do 4 tjedna da bi terapija počela djelovati, a liječenje depresije treba nastaviti do 6 mjeseci nakon što se stanje bolesnika poboljša.
English: The Committee agreed that the medicine could also be used in children from 6 years of age to treat nocturnal enuresis.
Croatian: Odbor se složio da se lijek smije primjenjivati i u djece u dobi od 6 i više godina za liječenje noćnog mokrenja.
English: It should only be prescribed by a specialist doctor and should only be used when physical causes of the problem (including conditions such as spina bifida) have been ruled out and when other treatments, including other medicines used for this problem, have not worked.
Croatian: Smije ga propisati samo liječnik specijalist, a smije se primjenjivati samo kada su isključeni fizički uzroci (uključujući stanja kao što je spina bifida) te kada druge terapije, uključujući druge lijekove primjenjivane za taj poremećaj nisu bile djelotvorne.
English: • treatment to prevent migraine.
Croatian: • liječenje kojim se suzbija migrena.
English: On 17 December 2015, the Greek medicines regulator, the National Organization for Medicines (EOF), referred the matter to the CHMP in order to harmonise the marketing authorisations for Saroten and associated names in the EU.
Croatian: Grčko regulatorno tijelo za lijekove, nacionalna organizacija za lijekove (EOF), uputila je 17. prosinca 2015. predmet CHMP-u radi usklađivanja odobrenja za stavljanje u promet lijeka Saroten i povezanih naziva u EU-u.
English: The CHMP harmonised other sections of the SmPC including the warnings and precautions relating to treatment (4.4), and recommendations not to use the medicine during pregnancy and to consider the risks and benefits of use during breast feeding (4.6).
Croatian: CHMP je također uskladio druge dijelove sažetka opisa svojstava lijeka uključujući upozorenja i mjere opreza povezane s liječenjem (4.4.), preporuke da se lijek ne koristi tijekom trudnoće te da je u razdoblju dojenja potrebno razmotriti koristi i rizike (4.6.).
English: Saroten must not be used in patients who are hypersensitive (allergic) to the medicine or any of its ingredients.
Croatian: Saroten se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na lijek ili na neki od njegovih sastojaka.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: To je dovelo do razilaženja između država članica u pogledu načina na koji se lijek može primjenjivati, što je vidljivo u razlikama između sažetaka opisa svojstava lijeka (SmPC), označivanja i uputa o lijeku u zemljama u kojima je lijek stavljen u promet.
English: On 23 February 2017, the European Medicines Agency completed a review of Saroten.
Croatian: Europska agencija za lijekove dovršila je ocjenjivanje lijeka Saroten 23. veljače 2017.
English: Saroten is a medicine used to treat a variety of conditions in the EU, including depression and various depressive states, a number of disorders associated with chronic (long-term) pain including the prevention of migraine or recurring headaches, and for the treatment of nocturnal enuresis (bedwetting) in children.
Croatian: U Europskoj uniji, Saroten je lijek namijenjen za liječenje raznih stanja, uključujući depresiju i različita depresivna stanja, više poremećaja povezanih s kroničnom (dugotrajnom) boli, uključujući sprječavanje migrene ili opetovanih glavobolja, te za liječenje noćne enureze (mokrenja u krevet) u djece.
English: While harmonising the use of Saroten in neuropathic pain and prevention of CTTH and migraine, the CHMP considered that Saroten should not be used for other forms of chronic pain.
Croatian: Usklađujući primjenu lijeka Saroten za liječenje neuropatske boli i sprječavanje kronične tenzijske glavobolje, CHMP smatra da se Saroten ne smije primjenjivati za liječenje drugih oblika kronične boli.
English: For initial treatment in hospital patients, Saroten can also be given as an injection into a muscle or a drip (infusion) into a vein.
Croatian: Na početku liječenja hospitaliziranih bolesnika, Saroten se može davati i u obliku injekcije u mišić ili kao infuzija (drip) u venu.
English: Saroten is available as modified-release capsules, tablets (including modifiedrelease tablets), and as a solution for injection.
Croatian: Saroten je dostupan u obliku kapsula s prilagođenim oslobađanjem, tableta (uključujući tablete s prilagođenim oslobađanjem) te kao otopina za injekciju.
English: For the treatment of bedwetting the dose is given an hour to an hour-and-a-half before bedtime and a course of treatment should last for a maximum of 3 months.
Croatian: Za liječenje mokrenja u krevet, doza se daje jedan sat do sat i pol prije odlaska na spavanje, a ciklus liječenja smije trajati najviše 3 mjeseca.
English: Patients must not receive treatment with certain other medicines called monoamine oxidase inhibitors (MAOIs) at the same time as Saroten, and there should be a gap (usually of two weeks) between stopping one of these medicines and starting Saroten, or vice versa.
Croatian: Dok su na terapiji lijekom Saroten, bolesnici se ne smiju istovremeno liječiti nekim drugim lijekovima pod nazivom inhibitori monoaminooksidaze (MAOI), a između prestanka primjene nekog od tih lijekova i početka liječenja Sarotenom, ili obrnuto, potreban je razmak (obično od dva tjedna).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: Uzimajući u obzir dostavljene podatke i znanstvene rasprave unutar Odbora, mišljenje je CHMP-a da se sažetci opisa svojstava, označivanje i upute za lijekove moraju uskladiti na razini EU-a.
English: Treatment is usually by mouth and the dose depends on the condition to be treated; as the strengths of the different tablets and capsules can vary, it is important to choose one that allows the right dose to be given.
Croatian: Budući da se jačine različitih tableta i kapsula mogu razlikovati, važno je odabrati onu koja omogućuje primjenu pravilne doze.
English: • treatment to prevent chronic tension-type headache (CTTH)
Croatian: • liječenje kronične tenzijske glavobolje
English: These recommendations should be reflected in the product information and communicated to healthcare professionals via a dedicated letter.
Croatian: Te je preporuke potrebno navesti u informacijama o lijeku i dostaviti zdravstvenim radnicima putem pisma.
English: The PRAC concluded that the risks observed were unlikely to be due to bias.
Croatian: PRAC je zaključio da opaženi rizici vjerojatno nisu posljedica pristranosti.
English: Interim results of the REASSURE study report also a significant concomitant use with enzalutamide in clinical practice (22%).
Croatian: Privremeni rezultati ispitivanja REASSURE također upućuju na značajnu istodobnu primjenu s enzalutamidom u kliničkoj praksi (22 %).
English: • Further to the review of the preliminary analyses available, the underlying mechanism for the increased risks of fracture and mortality observed in ERA 233, and therefore the potential impact of these findings in the authorised indication, remain uncertain.
Croatian: • Nastavno na pregled dostupnih preliminarnih analiza, mehanizam koji uzrokuje povećane rizike od prijeloma i smrtnosti opaženi u ispitivanju ERA 233, a stoga i potencijalni učinak ovih nalaza u odobrenoj indikaciji, ostaju neizvjesni.
English: Annex IV Scientific conclusions radium Ra223 dichloride
Croatian: radij Ra223 diklorid
English: The current recommendation relates only to provisional measures recommended by the PRAC for radium-223 dichloride based on the preliminary data available at this time.
Croatian: Ova se preporuka odnosi samo na privremene mjere koje preporučuje PRAC za radij-223 diklorid na temelju trenutačno dostupnih preliminarnih podataka.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisation for Xofigo (radium Ra223 dichloride).
Croatian: Posljedično tomu, Odbor preporučuje izmjene uvjeta odobrenja za stavljanje u promet lijeka Xofigo (radij Ra223 diklorid).
English: Whilst the exact extent of use of radium-223 in combination with abiraterone acetate and prednisolone/prednisone in clinical practice is not known, interim data from an observational study (REASSURE) reported that 5% of patients were treated with this combination.
Croatian: Dok točan opseg uporabe radija-223 u kombinaciji s abirateronacetatom i prednizonom/prednizolonom u kliničkoj praksi nije poznat, privremeni podaci iz opservacijskog ispitivanja (REASSURE) upućuju na to da je 5 % bolesnika liječeno ovom kombinacijom.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, in particular regarding the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004 for Xofigo (radium Ra223 dichloride) and taking into account the grounds set out in Articles 116 of Directive 2001/83/EC.
Croatian: Uredbe (EZ) br. 726/2004 koji je proizašao iz podataka o farmakovigilanciji, posebno u pogledu potrebe donošenja privremenih mjera u skladu s člankom 20. stavkom 3. Uredbe (EZ) br. 726/2004, za lijek Xofigo (radij Ra-223 diklorid) i uzimajući u obzir razloge utvrđene u članku 116.
English: The PRAC also considered data from the pivotal clinical trial ALSYMPCA which supported the marketing authorisation of Xofigo, as well as data from other completed and ongoing studies which became available since the marketing authorisation.
Croatian: PRAC je također razmotrio podatke iz ključnog kliničkog ispitivanja ALSYMPCA kojima se potkrepljuje odobrenje za stavljanje u promet lijeka Xofigo, kao i podatke iz ostalih završenih ispitivanja i onih u tijeku, koji su postali dostupni nakon davanja odobrenja za stavljanje u promet.
English: The PRAC also noted that data available show that radium Ra223 dichloride is used to some extent in clinical practice in combination with anti-androgens such as abiraterone and enzalutamide.
Croatian: PRAC je također napomenuo da dostupni podatci pokazuju da se radij Ra-223 diklorid u određenoj mjeri upotrebljava u kliničkoj praksi u kombinaciji s antiandrogenima, kao što su abirateron i enzalutamid.
English: • The PRAC noted that the use of radium Ra223 dichloride in Study ERA 223 was at earlier stages of the disease, albeit partially overlapping with that included in the authorised indication.
Croatian: • PRAC je napomenuo da je uporaba radija Ra-223 diklorida u ispitivanju ERA 223 bila u ranijim fazama bolesti, premda se djelomično preklapala s onom uključenom u odobrenoj indikaciji.
English: Whilst at this stage it is not excluded that the concurrent administration of radium-223 + abiraterone + prednisolone/prednisone is critical to the subsequent increased risks of fractures and death, it cannot be excluded either that the risks observed could apply to other effective androgen receptor antagonists.
Croatian: Iako u ovoj fazi nije isključeno da je istodobna primjena radija-233, abiraterona i prednizolona/prednizona odlučujuća za posljedično povećane rizike od prijeloma i smrtnih slučajeva, ne može se niti isključiti da se opaženi rizici mogu primijeniti na ostale učinkovite antagoniste androgenih receptora.
English: These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 of Regulation (EC) No
Croatian: Tim privremenim mjerama ne dovodi se u pitanje ishod pregleda na temelju postupka iz članka 20.
English: The clinical efficacy of radium-223 dichloride in the authorised indication was established during the initial marketing authorisation application based on the assessment of data from one pivotal phase III study (15245/BC1-06, ALSYMPCA), in which an improved overall survival and delayed symptomatic skeletal events were observed.
Croatian: Klinička učinkovitost radijum-223 diklorida u odobrenoj indikaciji utvrđena je prilikom podnošenja inicijalnog zahtjeva za odobrenje za stavljanje u promet, i to na temelju procjene podataka iz jednog ključnog ispitivanja faze III. (15245/BC1-06, ALSYMPCA), u kojem je opaženo poboljšano ukupno preživljenje i odgođeni simptomatski događaji povezani sa skeletom.