FrancophonIA/ELRC3.0 huggingface dataset:
English: During the assessment, the PRAC also noted that the MAH stated that available data no longer support tonsillitis and laryngitis indications; the MAH also confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical safety and benefit of fusafungine in the management of diseases of the upper respiratory airways.
Croatian: Nositelj odobrenja za stavljanje u promet također je potvrdio da su dostavljeni svi dostupni podaci te da neće biti u mogućnosti pružiti nikakve dodatne podatke za dokazivanje kliničke sigurnosti i koristi fusafungina u liječenju bolesti gornjih dišnih putova.
English: CMDh position
Croatian: Fusaloyos
English: Further risk minimisation measures such as additional amendments to the product information (further restriction of the indication and contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were therefore also considered during the discussions.
Croatian: Stoga je tijekom rasprava razmotrena i mogućnost uvođenja dodatnih mjera minimizacije rizika kao što su dodatne izmjene informacija o lijeku (dodatno ograničavanje indikacija i kontraindikacije, ograničavanje trajanja liječenja, dodavanje teksta „nemojte inhalirati” u posebna upozorenja i mjere opreza pri uporabi, ograničavanje pomoćnih tvari), komunikacijski materijali (obavijesti za neposredne zdravstvene djelatnike) i uvođenje ograničavajuće napomene o tome da je lijek dostupan samo na liječnički recept.
English: Further risk minimisation measures, as proposed by the MAH, such as additional amendments to the product information (further restriction of the indication and additional contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were also considered during the discussions.
Croatian: Tijekom rasprava razmotrena je i mogućnost uvođenja dodatnih mjera minimizacije rizika, kako je predložio nositelj odobrenja za stavljanje u promet, kao što su dodatne izmjene informacija o lijeku (dodatno ograničavanje indikacija i dodatne kontraindikacije, ograničavanje trajanja liječenja, dodavanje teksta „nemojte inhalirati” u posebna upozorenja i mjere opreza pri uporabi, ograničavanje pomoćnih tvari), komunikacijski materijali (obavijesti za neposredne zdravstvene djelatnike) i uvođenje ograničavajuće napomene o tome da je lijek dostupan samo na liječnički recept.
English: The PRAC reviewed all the available data submitted with regards to the clinical efficacy and safety of fusafungine-containing products.
Croatian: PRAC je pregledao sve dostupne podatke koji su dostavljeni u pogledu kliničke djelotvornosti i sigurnosti lijekova koji sadrže fusafungin.
English: Fusafungine , used in the form of a spray, is indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth.
Croatian: Fusafungin je antibakterijski depsipeptid koji se dobiva iz gljivice Fusarium lateritium, rod 437. Fusafungin, koji se koristi u obliku spreja, indiciran je za lokalno antibakterijsko i protuupalno liječenje bolesti gornjih dišnih putova (sinusitisa, rinitisa, rinofaringitisa, angine, laringitisa) i primjenjuje se tako da se inhalira u uobičajenim dozama od 500 mikrograma u obje nosnice ili putem usta svaka četiri sata.
English: The PRAC therefore concluded that the benefit-risk balance of fusafungine-containing medicinal products for oromucosal and nasal use is not favourable.
Croatian: PRAC je stoga zaključio da omjer koristi i rizika lijekova koji sadrže fusafungin za usnu sluznicu i za nos nije povoljan.
English: Value of Locabiotal Aerosol in rhinosinusitis Rhinology
Croatian: Pressurisé dans les rhinosinusites.
English: Its bacteriostatic properties were presented as an additional activity by the MAH.
Croatian: Nositelj odobrenja za stavljanje u promet naveo je da bakteriostatična svojstva lijeka pružaju dodatno djelovanje.
English: 2000, Study report [NP07760] 3 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
Croatian: 2000., Izvješće o ispitivanju [NP07760] 3 Bouter K., Sedmodnevno liječenje akutnog zaraznog rinofaringitisa fusafunginom (1,0 mg četiri puta dnevno):
English: The PRAC reviewed all the available data submitted with regards to the clinical efficacy of fusafunginecontaining products.
Croatian: PRAC je ponovno pregledao sve dostupne podatke koji su dostavljeni u pogledu kliničke djelotvornosti lijekova koji sadrže fusafungin.
English: The PRAC reviewed all the available data submitted with regards to the clinical safety of fusafunginecontaining products.
Croatian: PRAC je ponovno pregledao sve dostupne podatke koji su dostavljeni u pogledu kliničke sigurnosti lijekova koji sadrže fusafungin.
English: Whereas
Croatian: Njemačka
English: FFU*** ................................................................................................................................................per 0.2 ml dose
Croatian: FFU*** ................................................................................................................................................po 0,2 ml doze
English: * propagated in fertilised hens' eggs from healthy chicken flocks.
Croatian: * umnoženih u oplođenim kokošjim jajima iz jata zdravih kokoši.
English: Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029) 10
Croatian: Reasortirani virus gripe* (živi oslabljeni) sljedećih sojeva**: A/California/7/2009 (H1N1)pdm09 kao soj (A/California/7/2009, MEDI 228029)
English: B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, MEDI 237751)
Croatian: B/Massachusetts/2/2012 kao soj (B/Massachusetts/2/2012, MEDI 237751)
English: 10 sprayers
Croatian: 10 raspršivača
English: Nasal use sprayer (glass/PE) 0.2ml
Croatian: Samo za nos raspršivač (staklo/PE)
English: Medicinal product no longer authorised
Croatian: Lijeku je ukinuto odobrenje za stavljanje lijeka u prom et
English: Packaging
Croatian: EU
English: Strength Pharmaceutical Form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Pakovanje Sastav (koncentracija)
English: Tell your doctor before taking this medicine, if:
Croatian: Obavijestite svog liječnika prije uzimanja ovog lijeka ako:
English: The frequency of these reactions is considered not known (cannot be estimated from the available data).
Croatian: Učestalost ovih reakcija je nepoznata (ne može se procijeniti na temelju dostupnih podataka).
English: If you cannot follow this instruction or have difficulty swallowing, please contact your doctor.
Croatian: Ako ne možete slijediti ovu uputu ili imate problema s gutanjem, obratite se svom liječniku.
English: Ferrous sulfate - Mouth ulceration (EPITT no 18623)
Croatian: Željezov sulfat - Ulceracija u ustima (EPITT br. 18623)
English: Adopted at the 4-8 July 2016 PRAC
Croatian: Usvojeno na sjednici PRAC-a 4. - 8. srpnja 2016.
English: To avoid this interference, [Product name] treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Croatian: Kako bi se izbjegla ova interferencija, liječenje [ime lijeka] potrebno je prekinuti najmanje 5 dana prije mjerenja razine CgA (vidjeti dio 5.1.).
English: • You are due to have a specific blood test (Chromogranin A)
Croatian: • Morate napraviti određenu krvnu pretragu (kromogranin A).
English: 3 - How to take [Product name] Swallow the tablet whole with water.
Croatian: 3 - Kako uzimati [naziv lijeka] Tabletu progutajte cijelu s vodom.
English: Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.
Croatian: Potrebno ih je uzimati prije ili tijekom obroka, ovisno o gastrointestinalnoj podnošljivosti.
English: Do not suck, chew or keep the tablet in your mouth.
Croatian: Nemojte sisati, žvakati niti zadržavati tabletu u ustima.
English: Post-marketing: The following ADRs have been reported during post-marketing surveillance.
Croatian: Nakon stavljanja lijeka u promet: Sljedeće nuspojave zabilježene su tijekom praćenja nakon stavljanja lijeka u promet.
English: Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.
Croatian: Bolesnici starije životne dobi i bolesnici s poremećajima gutanja također mogu biti izloženi riziku od pojave lezija jednjaka ili nekroze dušnica, u slučaju pogrešnog puta primjene.
English: The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.
Croatian: Tablete se ne smiju sisati, žvakati niti zadržavati u ustima nego ih treba progutati cijele s vodom.
English: Not known (frequency cannot be estimated from the available data) Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth) Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways.
Croatian: Bolesnici starije životne dobi i bolesnici s problemima pri gutanju također mogu biti izloženi riziku od pojave vrijedova u grlu, jednjaku (cjevastom organu koji povezuje usta sa želucem) ili dušnicama (glavnim dišnim putovima u plućima) ako tableta dospije u dišne putove.
English: Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water.
Croatian: Zbog rizika od pojave vrijedova u ustima ili promjene boje zubiju, tablete se ne smiju sisati, žvakati niti zadržavati u ustima nego ih treba progutati cijele s vodom.
English: Gastrointestinal disorders: mouth ulceration* * in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth.
Croatian: ulceracija u ustima* * u kontekstu nepravilnog načina primjene, odnosno pri žvakanju, sisanju ili zadržavanju tableta u ustima.
English: Proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Elevated circulating levels of Chromogranin A (EPITT no 18614)
Croatian: Inhibitori protonske pumpe (IPP-ovi): dekslanzoprazol, esomeprazol, lanzoprazol, omeprazol, pantoprazol i rabeprazol
English: The recommended dose is one tablet daily, swallowed whole with water.
Croatian: Preporučena je doza jedna tableta dnevno, koja se treba progutati cijela s vodom.
English: If patients need to stop taking one of the active substances in the medicine, or need to take different doses, they will need to change to separate individual medicines.
Croatian: Ako bolesnik treba prestati uzimati jednu od djelatnih tvari u lijeku ili uzeti drugačiju dozu, treba se prebaciti na pojedinačne lijekove.
English: This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Atripla.
Croatian: To znači da sadržava iste djelatne tvari i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Atripla.
English: It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to any of the active substances in the medicine.
Croatian: Primjenjuje se samo u bolesnika koji su dobro odgovorili na trenutačno liječenje infekcije HIV-om te nemaju infekciju koja je otporna na liječenje ili koja vjerojatno neće reagirati ni na jednu od djelatnih tvari u lijeku.
English: The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Croatian: Edukacijski paket sadržava i preporuke za nadzor bubrežne funkcije u bolesnika koji primaju lijek.
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one.
Croatian: Tvrtka koja stavlja lijek na tržište osigurat će da svi liječnici od kojih se očekuje propisivanje lijeka dobiju edukacijski paket koji obuhvaća informacije o povećanom riziku od bolesti bubrega nakon primjene lijekova koji sadržavaju tenofovirdizoproksil, kao što je ovaj.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EUu te uvjete za njegovu primjenu.
English: Recommendations and precautions to be followed by healthcare professionals and patients for its safe and effective use 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 nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The European Medicines Agency concluded that, in accordance with EU requirements, the medicine has been shown to have comparable quality and to be bioequivalent to Atripla.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, dokazano da lijek posjeduje usporedivu kakvoću te da je bioekvivalentan lijeku Atripla.
English: The company also carried out a study that showed that the medicine is ‘bioequivalent' to the reference medicine.
Croatian: Tvrtka je također provela ispitivanje koje je pokazalo da je lijek „bioekvivalentan” referentnom lijeku.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan antivirusni je lijek koji se primjenjuje za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenoj uporabi već su provedena s referentnim lijekom Atripla i ne treba ih ponavljati za lijek Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: This medicine should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine).
Croatian: Ovaj se lijek ne smije uzimati istodobno s drugim lijekovima koji sadržavaju efavirenz, emtricitabin ili tenofovirdizoproksil ili lamivudin (drugi antivirusni lijek).
English: What is Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan and what is it used for?
Croatian: Što je Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan i za što se koristi?
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Croatian: Ovaj lijek sadržava tri djelatne tvari: efavirenz, nenukleozidni inhibitor reverzne transkriptaze (NNRTI); emtricitabin, nukleozidni inhibitor reverzne transkriptaze; i tenofovirdizoproksil, odnosno „prolijek” za tenofovir, što znači da se u tijelu pretvara u djelatnu tvar tenofovir.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Croatian: I nukleotidni i nukleozidni inhibitor reverzne transkriptaze poznati su kao NRTI.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan keeps the amount of HIV in the blood at a low level.
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan zadržava količinu HIV-a u krvi na niskoj razini.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz / emtricitabine / tenofovir disoproxil
Croatian: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz/emtricitabin/tenofovirdizoproksil
English: For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Croatian: Ostale informacije o lijeku Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
English: This summary was last updated in 01-2017.
Croatian: Ovaj sažetak je posljednji put ažuriran: 01.2017.
English: A patient should not be given more than two injections within any 24-hour period.
Croatian: Bolesnik ne smije primiti više od dvije injekcije unutar razdoblja od 24 sata.
English: It is given by slow injection into a vein lasting around five minutes.
Croatian: Primjenjuje se polaganom injekcijom u venu koja traje otprilike pet minuta.
English: One injection is usually enough to treat an attack, but a second injection may be given if the patient does not improve enough after the first one.
Croatian: Jedna injekcija obično je dovoljna za liječenje napadaja, a druga se injekcija može dati ako se stanje bolesnika nakon prve injekcije ne poboljša dovoljno.
English: The company will also provide prescribers with an alert card for their patients.
Croatian: Tvrtka će propisivačima također dostaviti kartice upozorenja za njihove bolesnike.
English: Ruconest conestat alfa
Croatian: Ruconest konestat alfa
English: Improvement was measured by the patients rating the severity of their symptoms on a scale from 0 to 100.
Croatian: Poboljšanje su izmjerili bolesnici ocjenjujući ozbiljnost svojih simptoma na ljestvici od 0 do 100.
English: In this case the powder that comes with the solvent should be used.
Croatian: U tom slučaju treba koristiti prašak koji dolazi s otapalom.
English: The main measure of effectiveness was how long it took for the symptoms to start to improve.
Croatian: Glavno mjerilo djelotvornosti bilo je vrijeme koje je prošlo do početka poboljšanja simptoma.
English: What is Ruconest and what is it used for?
Croatian: Što je Ruconest i za što se koristi?
English: The full EPAR for Ruconest can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Ruconest nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Ruconest?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ruconest?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ruconest on 28 October 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ruconest na snazi u Europskoj uniji od 28. listopada 2010.
English: Patients may be able to inject the medicine themselves after they have been properly trained.
Croatian: Pojedini bolesnici mogu si sami ubrizgati lijek ako su prošli odgovarajuću obuku.
English: The most common side effect with Ruconest (seen in between 1 and 10 patients in 100) is headache.
Croatian: Najčešća nuspojava zabilježena pri primjeni lijeka Ruconest (može se javiti u 1 do 10 bolesnika na njih 100) je glavobolja.
English: Other information about Ruconest
Croatian: Ostale informacije o lijeku Ruconest
English: Patients receiving placebo started to improve after four hours in one study and after over eight hours in the other.
Croatian: U bolesnika koji su primili placebo poboljšanja su počela nakon četiri sata u jednom ispitivanju te nakon više od osam sati u drugom.
English: When an attack occurred, the patients were given Ruconest or placebo (a dummy treatment).
Croatian: Kada je nastupio napadaj, bolesnici su primili lijek Ruconest ili placebo (prividno liječenje).
English: Ruconest was more effective than placebo at improving the symptoms of patients having an attack of angioedema.
Croatian: Ruconest je bio djelotvorniji od placeba u poboljšanju simptoma u bolesnika koji su imali napadaj angioedema.
English: When it is given during an angioedema attack, conestat alfa stops this excessive activity, helping to relieve the patient's symptoms.
Croatian: Ako se primjenjuje tijekom napadaja angioedema, konestat alfa zaustavlja tu prekomjernu aktivnost, pomažući tako pri ublažavanju simptoma u bolesnika.
English: Patients receiving Ruconest at doses of 50 units/kg and 100 units/kg started to improve after one and two hours.
Croatian: U bolesnika koji su primili lijek Ruconest u dozama od 50 jedinica/kg i 100 jedinica/kg poboljšanja su počela nakon jednoga te dva sata.
English: This is a summary of the European public assessment report (EPAR) for Ruconest.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Ruconest.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ruconest 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 Ruconest nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
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 Ruconest.
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 te preporuke o uvjetima za primjenu lijeka Ruconest.
English: Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema.
Croatian: U bolesnika s niskim koncentracijama tog proteina ta dva sustava prekomjerno su aktivna, što rezultira pojavom simptoma angioedema.
English: What is the risk associated with Ruconest?
Croatian: Koji su rizici povezani s lijekom Ruconest?
English: Ruconest is available as a powder (with or without solvent) that is made up into a solution for injection.
Croatian: Lijek Ruconest dostupan je kao prašak (s otapalom ili bez njega) za pripremu otopine za injekciju.
English: Why is Ruconest approved?
Croatian: Zašto je lijek Ruconest odobren?