FrancophonIA/ELRC3.0 huggingface dataset:
English: They were authorised through national approval procedures under various trade names (Bioparox, Fusaloyos, Locabiotal and Locabiosol) in the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain.
Croatian: Putem nacionalnih postupaka izdavanja odobrenja odobreni su pod raznim trgovačkim nazivima (Bioparox, Fusaloyos, Locabiotal i Locabiosol) u sljedećim zemljama: Austriji, Belgiji, Bugarskoj, Cipru, Češkoj Republici, Estoniji, Grčkoj, Irskoj, Italiji, Latviji, Litvi, Luksemburgu, Mađarskoj, Malti, Njemačkoj, Portugalu, Rumunjskoj, Slovačkoj i Španjolskoj.
English: In some Member States, these medicines were available without prescription.
Croatian: U nekim su državama članicama ti lijekovi bili dostupni bez liječničkog recepta.
English: • Healthcare professionals should advise patients on alternative treatments, if needed.
Croatian: • Zdravstveni djelatnici trebaju po potrebi savjetovati pacijente o alternativnim načinima liječenja.
English: Fusafungine-containing medicines have been available in several EU countries for over 50 years.
Croatian: Lijekovi koji sadrže fusafungin dostupni su u nekoliko zemalja EU-a više od 50 godina.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 1 CMDh je regulatorno tijelo za lijekove koje zastupa države članice Europske unije (EU) 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The CMDh is a regulatory body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Croatian: CMDh je regulatorno tijelo koje zastupa države članice EU-a te Island, Lihtenštajn i Norvešku.
English: • Patients with any questions should speak to their healthcare professional.
Croatian: • Bolesnici koji imaju bilo kakvih pitanja trebaju se obratiti zdravstvenom djelatniku koji skrbi o njihovu zdravlju.
English: In addition, there were concerns about the potential for fusafungine to promote antibiotic resistance (the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth).
Croatian: Osim toga, postojala je zabrinutost u pogledu toga da bi fusafungin mogao poticati razvoj rezistencije na antibiotike (sposobnost bakterija da rastu u prisutnosti antibiotika koji bi ih inače uništio ili ograničio njihov rast).
English: As fusafungine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position on 31 March 2016.
Croatian: Budući da su svi lijekovi koji sadrže fusafungin odobreni na nacionalnoj razini, PRAC-ova preporuka proslijeđena je Koordinacijskoj skupini za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) koja je donijela konačnu odluku 31. ožujka 2016.
English: Although the review found that serious allergic reactions are rare, they can be life-threatening and no measures have been identified to sufficiently reduce or manage this risk.
Croatian: Iako je ponovnim ocjenjivanjem utvrđeno da su teške alergijske reakcije rijetke, one mogu biti opasne po život, a nisu utvrđene nikakve mjere kojima bi se u dovoljnoj mjeri smanjio ili kontrolirao taj rizik.
English: Serious allergic reactions have occurred soon after the use of these sprays and involved bronchospasm (excessive and prolonged contractions of the airway muscles leading to difficulty breathing).
Croatian: Teške alergijske reakcije pojavljivale su se ubrzo nakon uporabe ovih sprejeva, a uključivale su bronhospazam (prekomjerne i dugotrajne kontrakcije mišića dišnih putova koje uzrokuju teškoće pri disanju).
English: The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Ponovno ocjenjivanje proveo je Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za procjenu sigurnosnih pitanja u području lijekova za humanu uporabu, koji je iznio niz preporuka.
English: • These sprays are being taken off the market in the EU because of rare cases of serious allergic reactions and the lack of strong evidence that these medicines work.
Croatian: • Ti se sprejevi povlače s tržišta u EU-u zbog rijetkih slučajeva teških alergijskih reakcija i manjka čvrstih dokaza o njihovoj djelotvornosti.
English: Although there is insufficient evidence to establish that fusafungine can increase the risk of resistance, this risk could not be ruled out.
Croatian: Iako ne postoje dostatni dokazi na osnovi kojih bi se utvrdilo da fusafungin može povećati rizik od rezistentnosti, taj se rizik ne može isključiti.
English: During its review the PRAC consulted EMA's paediatric scientific committee as well as experts in the field of anti-infective medicines.
Croatian: Tijekom ocjenjivanja, PRAC se savjetovao s EMA-inim pedijatrijskim znanstvenim odborom te sa stručnjacima iz područja protuinfektivnih lijekova.
English: • Upper airway infections are usually mild and self-limiting.
Croatian: • Infekcije gornjih dišnih putova obično su blage i samoograničavajuće prirode.
English: Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit
Croatian: Lijekovi koje treba povući zbog teških alergijskih reakcija koje izazivaju i ograničenih dokaza o koristi
English: As the CMDh adopted its position by consensus, the measures recommended by the PRAC will be implemented directly by the Member States where the medicines are authorised, according to an agreed timetable.
Croatian: Budući da je CMDh svoje stajalište donio konsenzusom, mjere koje je PRAC preporučio izravno će provesti države članice u kojima su ti lijekovi odobreni u skladu s dogovorenim rasporedom.
English: This follows a review by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which concluded that the benefits of fusafungine do not outweigh its risks, particularly the risk of serious allergic reactions.
Croatian: To je uslijedilo nakon što je EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC) proveo ponovno ocjenjivanje na osnovi kojeg je zaključeno da koristi od fusafungina ne nadmašuju s njime povezane rizike, a osobito rizik od teških alergijskih reakcija.
English: The CMDh1 has endorsed by consensus the revocation of marketing authorisations for fusafungine sprays in the EU.
Croatian: CMDh1 je konsenzusom podržao opoziv odobrenja za stavljanje u promet sprejeva koji sadrže fusafungin u EU-u.
English: Fusafungine is an antibiotic and anti-inflammatory medicine used in the form of a nasal and oromucosal (to be applied to the mouth) spray for the treatment of the following infections of the upper airways: sinusitis (sinus infection), rhinitis (stuffy and runny nose), rhinopharyngitis (common cold), tonsillitis (inflammation of the tonsils caused by an infection) and laryngitis (inflammation of the voice box).
Croatian: Fusafungin je antibakterijski i protuupalni lijek koji se koristi u obliku spreja za nos i usnu sluznicu (putem usta) za liječenje sljedećih infekcija gornjih dišnih putova: sinusitisa (infekcije sinusa), rinitisa (začepljenog nosa i hunjavice), rinofaringitisa (prehlade), tonzilitisa (upale krajnika uzrokovane infekcijom) i laringitisa (upale grkljana i glasnica).
English: Taking into account the mild and self-limiting nature of upper airway infections such as rhinopharyngitis, the benefits of fusafungine were not considered to outweigh the risks.
Croatian: Uzimajući u obzir blagu i samoograničavajuću prirodu infekcija gornjih dišnih putova kao što je rinofaringitis, zaključeno je da koristi od fusafungina ne nadmašuju s njime povezane rizike.
English: The benefit-risk balance for fusafungine-containing medicines is therefore negative for all currently authorised uses.
Croatian: Stoga je omjer koristi i rizika lijekova koji sadrže fusafungin negativan za sve trenutačno odobrene primjene.
English: With regard to the benefits, the evidence for beneficial effects of fusafungine is weak.
Croatian: U pogledu koristi od lijeka, utvrđeno je da postoje slabi dokazi o korisnim učincima fusafungina.
English: Following the CMDh consensus position, EU Member States will start revoking the marketing authorisations of these medicines in their territories, according to an agreed timetable.
Croatian: Nakon objave konsenzusnog stajališta CMDh-a, države članice EU-a počet će opozivati odobrenja za stavljanje u promet tih lijekova na svojim državnim područjima u skladu s dogovorenim rasporedom.
English: Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).
Croatian: Fusafungin je antibakterijski i protuupalni sprej za nos i usta koji se koristi za liječenje infekcija gornjih dišnih putova kao što je rinofaringitis (prehlada).
English: • Fusafungine nose and mouth sprays have been used to treat upper airway infections.
Croatian: • Sprejevi za nos i usta koji sadrže fusafungin koristili su se za liječenje infekcija gornjih dišnih putova.
English: 1 April 2016 EMA/227560/2016
Croatian: 1. travnja 2016.
English: Page 2/2
Croatian: Tel.
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Croatian: [trenutno odobrene indikacije niže navedene moraju se izbrisati (specifičan način opisa indikacija može se razlikovati od lijeka do lijeka)]
English: • Orthostatic hypotension
Croatian: • Ortostatska hipotenzija
English: • Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Croatian: • Simptomatsko liječenje veno-limfatične insuficijencije Sve reference na gore navedene indikacije moraju se izbrisati iz svih ostalih odgovarajućih dijelova sažetaka opisa svojstava lijeka.
English: • Prophylaxis of migraine headache
Croatian: • Profilaksa migrenske glavobolje
English: A. Summary of Product Characteristics
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: EU/1/19/1389/001 Epidyolex 100 mg/mL Oral Solution
Croatian: EU/1/19/1389/001 Epidyolex 100 mg/ ml
English: 1 bottle + 2 syringes of 1 ml + 2 syringes of 5 ml + 2 bottle adaptors
Croatian: 2 štrcaljke od 1 ml + 2 štrcaljke od 5 ml + 2 adaptera za bočicu
English: 100 ml
Croatian: Boca (staklo) 100 ml
English: Let stand for 20 minutes.
Croatian: Ostaviti stajati 20 minuta.
English: 04011 Campoverde di Aprilia (LT) Italy
Croatian: 04011 Campoverde di Aprilia (LT) Italija
English: Not relevant.
Croatian: Nije primjenjivo.
English: Any remaining contents should be discarded after use.
Croatian: Preostali sadržaj treba baciti nakon uporabe.
English: However in-use stability has been demonstrated for 3 hours at 20 - 24oC.
Croatian: Ipak, dokazana je stabilnost pri korištenju tijekom 3 sata na 20 - 24°C.
English: In some cases, fatalities have been reported (see section 4.8).
Croatian: U nekim su slučajevima prijavljeni smrtni ishodi (vidjeti dio 4.8).
English: No significant findings were observed.
Croatian: Nisu dobivena značajna zapažanja.
English: No medical consequences were identified in these instances.
Croatian: Nisu zabilježene nikakve medicinske posljedice u tim slučajevima.
English: Where possible, the first dose should be administered prior to commencement of the RSV season.
Croatian: Ako je moguće, prvu dozu treba dati prije početka sezone RSV-a.
English: There was no association observed between the presence of antibody and adverse events.
Croatian: Nije primijećena povezanost između prisutnosti antitijela i štetnih događaja.
English: These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg.
Croatian: Te doze su bile 20,25 mg/kg, 21,1 mg/kg i 22,27 mg/kg.
English: Date of first authorisation: 13 August 1999 Date of latest renewal: 27 July 2009
Croatian: Datum posljednje obnove odobrenja: 27. srpnja 2009.
English: AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, USA
Croatian: AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, SAD
English: In the first study, all 153 premature infants received both formulations in different sequences.
Croatian: U prvom ispitivanju je svih 153 nedonoščadi dobivalo obje formulacije u različitim sekvencama.
English: Injection volumes over 1 ml should be given as a divided dose.
Croatian: Injekcijske volumene veće od 1 ml treba dati kao podijeljenu dozu.
English: If your child misses an injection, you should contact your doctor as soon as possible.
Croatian: Ako Vaše dijete propusti injekciju, obratite se liječniku što je prije moguće.
English: Subjects were followed for safety and efficacy for 150 days.
Croatian: Kod ispitanika je 150 dana praćena sigurnost i djelotvornost.
English: The injection should be given using standard aseptic technique.
Croatian: Injekciju treba dati koristeći standardnu aseptičku tehniku.
English: Data on fertility, pregnancy and lactation are not available.
Croatian: Podaci o plodnosti, trudnoći i dojenju nisu dostupni.
English: After reconstitution, the product should be used immediately.
Croatian: Nakon rekonstitucije, lijek treba odmah upotrijebiti.
English: For your child's best protection, it is necessary to take the doctor's advice about when to return for additional doses of Synagis.
Croatian: Za najbolju zaštitu Vašeg djeteta, nužno je da slijedite liječnikove upute o tome kada se treba vratiti po dodatne doze lijeka Synagis.
English: What Synagis is and what it is used for
Croatian: Što je Synagis i za što se koristi
English: Use within 3 hours of reconstitution.
Croatian: Upotrijebiti unutar 3 sata od pripreme.
English: The majority of clinical RSV isolates tested (n=96) were collected from subjects in the United States.
Croatian: Većina ispitanih kliničkih izolata RSV-a (n=96) prikupljena je od ispitanika u Sjedinjenim Američkim Državama.
English: Store in a refrigerator (2ºC to 8ºC).
Croatian: Čuvati u hladnjaku (2ºC - 8ºC).
English: The onset of the adverse reactions occurred after the sixth or greater dose in only 22 of these reports (15 after the sixth dose, 6 after the seventh doses and 1 after the eight dose).
Croatian: Nuspojave su se javile nakon šeste ili kasnije doze samo u 22 od tih prijava (15 nakon šeste doze, 6 nakon sedme doze i 1 nakon osme doze).
English: Pack size of 1.
Croatian: Veličina pakiranja je 1.
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake ‘EXP'.
English: • Children less than 2 years of age and with haemodynamically significant congenital heart disease.
Croatian: • Djeca mlađa od 2 godine s hemodinamski značajnom kongenitalnom bolesti srca.
English: One hundred and three (103) children received monthly palivizumab injections for the first time, and 119 children received palivizumab for two consecutive seasons.
Croatian: Stotinu i troje djece (103) dobivalo je mjesečne injekcije palivizumaba po prvi put, dok je preostalih 119 dobivalo palivizumab već drugu sezonu zaredom.
English: In vitro studies of antiviral activity
Croatian: In vitro ispitivanja protuvirusnog djelovanja
English: What Synagis looks like and contents of the pack
Croatian: Kako Synagis izgleda i sadržaj pakiranja
English: Synagis solution for injection is a ready to use formulation.
Croatian: Synagis otopina za injekciju je formulacija spremna za uporabu.
English: This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences.
Croatian: Ovo humanizirano monoklonsko antitijelo se sastoji od sekvenci ljudskih (95%) i mišjih (5%) antitijela.
English: Subsequent doses should be administered monthly throughout the RSV season.
Croatian: Naredne doze treba davati mjesečno tijekom cijele sezone RSV-a.
English: What Synagis contains
Croatian: Što Synagis sadrži
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Croatian: U slučaju predoziranja preporučuje se nadzirati bolesnika na znakove i simptome nuspojava ili štetnih učinaka i odmah uspostaviti primjereno simptomatsko liječenje.
English: Take special care with Synagis if your child is unwell.
Croatian: Budite posebno oprezni s lijekom Synagis ako se Vaše dijete ne osjeća dobro.
English: Synagis is not indicated for use in adults.
Croatian: Synagis nije indiciran za primjenu u odraslih.
English: To ensure the correct volume is reconstituted for Synagis, see section 6.6.
Croatian: Kako bi se osigurala rekonstitucija točnog volumena lijeka Synagis, vidjeti dio 6.6.
English: Therefore, anti-drug antibody (ADA) responses appear to be of no clinical relevance.
Croatian: Prema tome, čini se da odgovori na antitijela protiv lijeka nemaju nikakve kliničke važnosti.
English: If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation.
Croatian: Ako se Vaše dijete sprema na operaciju srca (ugradnja srčane premosnice), može primiti jednu dodatnu dozu lijeka Synagis nakon operacije.
English: Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections.
Croatian: U toj je skupini 1250 praćene dojenčadi dobilo 6 injekcija, 183 dojenčadi 7 injekcija, a 27 dojenčadi 8 ili 9 injekcija.
English: The majority of experience including the pivotal phase III clinical trials with palivizumab has been gained with 5 injections during one season (see section 5.1).
Croatian: Većina iskustva, uključujući i ispitivanje palivizumaba u pivotalnim kliničkim ispitivanjima faze III, stečena je primjenom 5 injekcija tijekom jedne sezone (vidjeti dio 5.1).
English: This was transient, low titre, resolved despite continued use (first and second season), and could not be detected in 55 of 56 infants during the second season (including 2 with titres during the first season).
Croatian: Ta pojava je bila prolazna, niskoga titra, nestala je unatoč nastavku liječenja (u prvoj i drugoj sezoni) i nije otkrivena u 55 od 56 dojenčadi za vrijeme druge sezone (uključujući 2 s pozitivnim titrom tijekom prve sezone).
English: The neutralization titre (50% effective concentration [EC50]) is expressed as the antibody concentration required to reduce detection of RSV antigen by 50% compared with untreated virus-infected cells.
Croatian: Titar neutralizacije (50% djelotvorne koncentracije [EC50]) izražen je kao koncentracija antitijela potrebna da se detekcija RSV antigena smanji za 50% u usporedbi s netretiranim stanicama inficiranim virusom.
English: Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.
Croatian: Vaše dijete primi ovaj lijek jer sadrži važne informacije za Vas i Vaše dijete.
English: Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.
Croatian: Odmah nazovite svog liječnika ili zatražite medicinsku pomoć ako Vaše dijete dobije neki od gore navedenih simptoma nakon što primi bilo koju dozu lijeka Synagis.
English: In clinical studies, three children received an overdose of more than 15 mg/kg.
Croatian: U kliničkim je ispitivanjima troje djece dobilo doze veće od 15 mg/kg.
English: Each injection of Synagis can only help protect your child for about one month before another injection is needed.
Croatian: Svaka injekcija lijeka Synagis može pomoći zaštititi Vaše dijete približno jedan mjesec prije nego što je potrebna sljedeća injekcija.
English: Two clinical studies were conducted to directly compare liquid and lyophilised formulations of palivizumab.
Croatian: Provedena su dva klinička ispitivanja kako bi se izravno usporedile tekuća i liofilizirana formulacija palivizumaba.
English: • Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
Croatian: • Djeca mlađa od 2 godine koja su u proteklih 6 mjeseci liječena zbog bronhopulmonalne displazije.
English: From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose (see section 4.8).
Croatian: Nakon stavljanja lijeka u promet, prijavljena su predoziranja dozama do 85 mg/kg te su u nekim slučajevima zabilježene nuspojave koje se nisu razlikovale od onih prijavljenih za dozu od 15 mg/kg (vidjeti dio 4.8).
English: Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.
Croatian: Otopinu palivizumaba treba ostaviti na sobnoj temperaturi najmanje 20 minuta dok se ne razbistri.
English: Immunogenicity was not studied in the congenital heart disease study.
Croatian: Imunogenost nije ispitivana u ispitivanju kongenitalne bolesti srca.
English: Patients with hemodynamically significant congenital heart disease were excluded from enrollment in this study and were studied in a separate study.
Croatian: Bolesnici s hemodinamski značajnom kongenitalnom bolesti srca nisu uključeni u ovo ispitivanje te su proučavani u zasebnom ispitivanju.
English: Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions.
Croatian: Stoga pri donošenju medicinskih odluka dobivene rezultate dijagnostičkih testova treba koristiti u kombinaciji s kliničkim nalazima.
English: The efficacy of palivizumab at doses other than 15 mg per kg or of dosing differently from monthly throughout the RSV season, has not been established.
Croatian: Djelotvornost palivizumaba u dozama različitima od 15 mg/kg ili doziranju različitom od jednom mjesečno tijekom cijele sezone RSV-a nije ustanovljena.
English: The frequency for these "ADRs" as presented in the table below was estimated using the safety data of the two registration clinical studies.
Croatian: Učestalost tih „nuspojava“ prikazana u sljedećoj tablici procijenjena je na temelju sigurnosnih podataka iz dvaju registracijskih kliničkih ispitivanja.
English: The overall rate and pattern of adverse events, study drug discontinuation due to AEs, and the number of deaths reported in these clinical studies were consistent with those observed during the clinical development programs for the lyophilised formulation.
Croatian: Ukupna stopa i uzorak štetnih događaja, prekid primjene ispitivanog lijeka zbog štetnih događaja te broj smrtnih slučajeva prijavljenih u ovim kliničkim ispitivanjima bili su u skladu s onima zabilježenim tijekom kliničkog razvoja liofilizirane formulacije.
English: It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Croatian: Ima snažni neutralizirajući učinak i inhibitorno djelovanje na fuzijsku aktivnost sojeva oba RSV podtipa A i B.
English: These adverse reactions are similar in character to those after the initial five doses.
Croatian: Te su nuspojave po karakteristikama bile slične onima zabilježenima nakon prvih pet doza.
English: What should you do if your child misses an injection of Synagis?
Croatian: Što učiniti ako Vaše dijete propusti primiti injekciju lijeka Synagis?
English: Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).
Croatian: Kod Vašeg djeteta postoji velik rizik nastanka bolesti uzrokovane virusom koji se zove respiratorni sincicijski virus (RSV).