FrancophonIA/ELRC3.0 huggingface dataset:
English: Your FlexPen is a pre-filled dial-a-dose insulin pen.
Croatian: Vaš FlexPen je napunjena inzulinska brizgalica s mogućnošću odabira doze inzulina.
English: NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps, as described in section 4.2.
Croatian: NovoRapid PumpCart namijenjen je za primjenu samo uz pomoć inzulinske infuzijske pumpe namijenjene za uporabu s ovim uloškom, kao što su inzulinske pumpe Accu-Chek Insight i YpsoPump, kako je opisano u dijelu 4.2. Ispitani su kateteri čija je unutarnja stijenka načinjena od polietilena ili poliolefina te je utvrđeno da su kompatibilni s pumpama.
English: * see section 4.8, Description of selected adverse reactions.
Croatian: Manje često - reakcije na mjestu injiciranja Manje često - edem * vidjeti dio 4.8, Opis odabranih nuspojava
English: EU/1/99/119/022
Croatian: EU/1/99/119/024 EU/1/99/119/025
English: MARKETING AUTHORISATION HOLDER Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Danska
English: 5 x 1.6 ml cartridges
Croatian: 5 uložaka od 1,6 ml
English: G Hold the pen with the needle pointing up.
Croatian: G Brizgalicu držite iglom okrenutom prema gore.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK (PRE-FILLED PEN.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA (NAPUNJENA BRIZGALICA.
English: ► NovoRapid FlexPen is only suitable for injecting under the skin.
Croatian: ► NovoRapid FlexPen je prikladan samo za ubrizgavanje pod kožu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACK (VIAL - with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA (BOČICA-s plavim okvirom)
English: Keep the vial/cartridge in the outer carton in order to protect from light.
Croatian: Bočicu/uložak čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: NovoRapid should never be mixed with any other insulin when used in a pump.
Croatian: NovoRapid koji se koristi u pumpi ne smije se nikada miješati s drugim inzulinima.
English: 1 pre-filled pen contains 3 ml equivalent to 300 units.
Croatian: NAVOĐENJE DJELATNE TVARI 1 napunjena brizgalica sadrži 3 ml, što odgovara 300 jedinica.
English: ► NovoRapid FlexTouch is only suitable for injecting under the skin.
Croatian: ► NovoRapid FlexTouch je prikladan samo za ubrizgavanje pod kožu.
English: Always keep the pen cap on your FlexPen when you are not using it in order to protect it from light.
Croatian: Uvijek držite zatvarač na brizgalici FlexPen kad je ne koristite, radi zaštite od svjetlosti.
English: How to use NovoRapid
Croatian: Kako primijeniti NovoRapid
English: NovoRapid FlexPen is only suitable for injecting under the skin.
Croatian: NovoRapid FlexPen je prikladan samo za ubrizgavanje pod kožu.
English: Name and address of the manufacturers responsible for batch release
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: NovoRapid 100 units/ml solution for injection in vial Insulin aspart
Croatian: NovoRapid 100 jedinica/ml otopina za injekciju aspart inzulin
English: NovoRapid PumpCart 100 units/ml solution for injection in cartridge Insulin aspart
Croatian: NovoRapid PumpCart 100 jedinica/ml otopina za injekciju u ulošku aspart inzulin
English: Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light.
Croatian: Uvijek držite zatvarač na brizgalici InnoLet kad je ne koristite, radi zaštite od svjetlosti.
English: Read carefully the instructions on how to use NovoRapid InnoLet included in this package leaflet.
Croatian: Pažljivo pročitajte upute za uporabu brizgalice NovoRapid InnoLet sadržane u ovoj uputi o lijeku.
English: METHOD OF ADMINISTRATION InnoLet
Croatian: Provjera protoka inzulina
English: Thereafter it can be used for up to 7 days below 37°C in an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
Croatian: Nakon toga može se primjenjivati u inzulinskim infuzijskim pumpama namijenjenima za uporabu s ovim uloškom, kao što su inzulinske pumpe Accu-Chek Insight i YpsoPump, do 7 dana na temperaturi ispod 37°C.
English: NovoRapid vial can also be used if intravenous administration of insulin aspart, by physicians or other healthcare staff, is applicable.
Croatian: Ako je potrebna intravenska primjena aspart inzulina od strane liječnika ili drugog zdravstvenog radnika također se može koristiti NovoRapid bočica.
English: How to take NovoRapid
Croatian: Kako primjenjivati NovoRapid
English: NovoRapid FlexTouch is only suitable for injecting under the skin.
Croatian: NovoRapid FlexTouch je prikladan samo za ubrizgavanje pod kožu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR MULTIPACK (PRE-FILLED PEN.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (NAPUNJENA BRIZGALICA.
English: You should always have an alternative delivery method for your insulin available for injection under the skin in case of pump system failure.
Croatian: U slučaju neispravnosti pumpe uvijek morate na raspolaganju imati neko drugo pomagalo za injiciranje inzulina pod kožu.
English: • Follow the instructions in the pump user manual that comes with your pump to insert a new NovoRapid PumpCart cartridge in your pump.
Croatian: • Kako biste stavili novi uložak NovoRapid PumpCart u pumpu, slijedite upute navedene u vodiču za korisnika kojeg ste dobili s pumpom.
English: • Bring NovoRapid PumpCart to room temperature.
Croatian: Prije umetanja uloška NovoRapid PumpCart u pumpu • NovoRapid PumpCart treba postići sobnu temperaturu.
English: B Remove the paper tab from a new disposable needle.
Croatian: Otrgnite papirnatu naljepnicu s nove igle za jednokratnu uporabu.
English: Store below 37°C Do not freeze
Croatian: Čuvati na temperaturi ispod 37°C.
English: NovoRapid FlexPen Pen cap
Croatian: NovoRapid FlexPen Zatvarač brizgalice
English: Thereafter it can be used for up to 7 days below 37°C in a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
Croatian: Nakon toga može se primijeniti u pumpi namijenjenoj za uporabu s ovim uloškom, kao što su inzulinske pumpe Accu-Chek Insight i YpsoPump, do 7 dana na temperaturi ispod 37°C.
English: Your NovoRapid FlexTouch pen is a pre-filled insulin pen.
Croatian: NovoRapid FlexTouch je napunjena inzulinska brizgalica.
English: Always keep the cartridge in the outer carton when you are not using it in order to protect it from light.
Croatian: Uvijek čuvajte uložak u vanjskoj kutiji kad ga ne koristite, radi zaštite od svjetlosti.
English: Other medicines and NovoRapid
Croatian: Prije primjene lijeka NovoRapid
English: NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen Insulin aspart
Croatian: NovoRapid InnoLet 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici aspart inzulin
English: NovoRapid FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Croatian: Primjena FlexPen brizgalicom NovoRapid FlexPen je napunjena brizgalica (označena bojom) namijenjena uporabi s jednokratnim iglama NovoFine ili NovoTwist duljine do 8 mm.
English: Read carefully the instructions on how to use NovoRapid FlexTouch included in this package leaflet.
Croatian: Pažljivo pročitajte upute za uporabu brizgalice NovoRapid FlexPen sadržane u ovoj uputi o lijeku.
English: 5 vials of 10 ml
Croatian: 1 bočica od 10 ml 5 bočica od 10 ml
English: Misuse of NovoRapid PumpCart
Croatian: Pogrešna uporaba uloška NovoRapid PumpCart
English: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Croatian: 3 ml otopine u ulošku (staklo tipa 1) s klipom (brombutil) i gumenim zatvaračem
English: NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen Insulin aspart
Croatian: NovoRapid FlexPen 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici aspart inzulin
English: H Press the dose button with your thumb until the dose counter returns to 0.
Croatian: Palcem pritisnite gumb za doziranje dok se brojčanik doze ne vrati na 0.
English: • Follow the instructions in the pump user manual to continue using your pump.
Croatian: • Za nastavak primjene pumpe slijedite upute navedene u vodiču za korisnika.
English: Do not use this medicine after the expiry date which is stated on the FlexTouch label and carton, after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici FlexPen brizgalice i kutiji iza oznake ‘Rok valjanosti'.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/119/001 1 vial of 10 ml EU/1/99/119/008 5 vials of 10 ml
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/119/001 1 bočica od 10 ml
English: NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen Insulin aspart
Croatian: NovoRapid FlexTouch 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici aspart inzulin
English: NovoRapid Penfill 100 units/ml solution for injection in cartridge Insulin aspart
Croatian: NovoRapid Penfill 100 jedinica/ml otopina za injekciju u ulošku aspart inzulin
English: MARKETING AUTHORISATION NUMBER EU/1/99/119/021 2 x 5 pens of 3 ml
Croatian: EU/1/99/119/021 2 x 5 brizgalica od 3 ml
English: Preparing your NovoRapid FlexPen
Croatian: Priprema NovoRapid FlexPen brizgalice
English: ► Remove and discard the needle after each injection.
Croatian: ► Nakon svakog injiciranja iglu skinite i bacite u otpad.
English: 1.6 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Croatian: 1,6 ml otopine u ulošku (staklo tipa 1) s klipom (brombutil) i gumenim zatvaračem
English: Phenol
Croatian: Penfill
English: Do not use this medicine after the expiry date which is stated on the InnoLet label and carton, after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici InnoLet brizgalice i kutiji iza oznake ‘Rok valjanosti'.
English: • Thyroid hormones (used to treat thyroid gland disorders)
Croatian: • hormone štitnjače (koriste se za liječenje poremećaja štitnjače)
English: Pen label Dose counter
Croatian: Naljepnica brizgalice
English: ► Discard the needle after each injection.
Croatian: ► Nakon svakog injiciranja iglu bacite u otpad.
English: Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light.
Croatian: Uvijek držite zatvarač na brizgalici FlexTouch kad je ne koristite, radi zaštite od svjetlosti.
English: Hold the dose button down until the dose counter returns to 0 after the injection.
Croatian: Nakon injekcije, držite gumb za doziranje pritisnutim dok se brojčanik doze ne vrati na 0.
English: How to store NovoRapid
Croatian: Kako čuvati NovoRapid
English: OTHER SPECIAL WARNINGS, IF NECESSARY Use solution only if clear and colourless For use by one person only
Croatian: Upotrijebiti otopinu samo ako je bistra i bezbojna.
English: NovoRapid vial
Croatian: NovoRapid bočica
English: MARKETING AUTHORISATION NUMBERS EU/1/99/119/003 5 cartridges of 3 ml EU/1/99/119/006 10 cartridges of 3 ml
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/119/003 5 uložaka od 3 ml
English: Always protect the cartridge from light during use.
Croatian: Tijekom primjene uvijek zaštitite uložak od svjetlosti.
English: EU/1/99/119/019 1 pen of 3 ml EU/1/99/119/020 5 pens of 3 ml EU/1/99/119/022 1 pen of 3 ml and 7 NovoFine needles EU/1/99/119/023 1 pen of 3 ml and 7 NovoTwist needles
Croatian: EU/1/99/119/022 1 brizgalica od 3 ml i 7 NovoFine igala
English: What NovoRapid PumpCart is and what it is used for What you need to know before you use NovoRapid PumpCart How to use NovoRapid PumpCart Possible side effects
Croatian: Što morate znati prije nego počnete primjenjivati NovoRapid PumpCart Nemojte primjenjivati NovoRapid PumpCart
English: Pointer
Croatian: NovoRapid
English: Do not use this medicine after the expiry date which is stated on the vial label and carton, after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici uloška i kutiji iza oznake ‘Rok valjanosti'.
English: Lipodystrophy:
Croatian: Lipodistrofija:
English: • Never share your pen or your needles with other people.
Croatian: • Nikada nemojte dijeliti svoju brizgalicu ili igle s drugim osobama jer može doći do prijenosa infekcije.
English: • Discard the needle after each injection.
Croatian: • Nakon svakog injiciranja iglu bacite u otpad.
English: NovoRapid Vial, InnoLet, FlexTouch and PumpCart:
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet NovoRapid bočica, InnoLet, FlexTouch i PumpCart: Novo Nordisk A/S
English: The main measure of effectiveness was a reduction in 1 or more grades of lameness using a scoring system that runs from 1 to 5.
Croatian: Glavno mjerilo učinkovitosti bilo je smanjenje hromosti za jedan ili više stupnjeva na temelju sustava bodovanja od 1 do 5.
English: The company that applied for authorisation is Centauri Biotech SL.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka Centauri Biotech SL.
English: Finally, the Committee had concerns about the way the medicine was manufactured and its quality ensured.
Croatian: Naposljetku, Odbor je izrazio zabrinutost u pogledu načina proizvodnje lijeka i jamčenja njegove kvalitete.
English: What were the CVMP's main concerns that led to the refusal?
Croatian: Koji su bili glavni razlozi za zabrinutost CVMP-a koji su doveli do odbijanja zahtjeva?
English: It was to be available as a suspension for injection into a joint.
Croatian: Trebao je biti dostupan kao suspenzija za primjenu injekcijom u zglob.
English: What is Horse Allo 20?
Croatian: Što je Horse Allo 20?
English: Following a request from the European Commission, the CVMP revised part of its opinion concerning compliance with Good Manufacturing Practice (GMP).
Croatian: Na zahtjev Europske komisije CVMP je revidirao dio svojeg mišljenja koji se odnosi na usklađenost s dobrom proizvođačkom praksom (GMP).
English: Osteoarthritis is a condition that causes swelling and pain in the joints and which is often associated with lameness.
Croatian: Osteoartritis je bolest koja uzrokuje oticanje i bol u zglobovima i koja je često povezana s hromošću.
English: The way that mesenchymal stem cells work has not been clearly established but published studies indicate that they have an anti-inflammatory action and may have an effect in regenerating tissue.
Croatian: Način djelovanja mezenhimalnih matičnih stanica nije jasno utvrđen, ali objavljena ispitivanja upućuju na to da one imaju protuupalno djelovanje i da mogu utjecati na regeneraciju tkiva.
English: The CVMP noted that there were problems with the way the main study was designed and carried out, and concluded that the effectiveness of the medicine had not been sufficiently demonstrated.
Croatian: CVMP je uočio probleme u pogledu oblikovanja i provedbe glavnog ispitivanja te je zaključio da učinkovitost VMP-a nije dostatno dokazana.
English: The CVMP was also concerned about the high number of side effects reported in the field study.
Croatian: CVMP je ujedno izrazio zabrinutost zbog velikog broja nuspojava zabilježenih u terenskom ispitivanju.
English: The Committee removed its previous objection that the company did not comply with GMP but all other concerns remained.
Croatian: Odbor je povukao svoj prethodni prigovor o neusklađenosti tvrtke s dobrom proizvođačkom praksom, ali su ostali prisutni svi ostali razlozi za zabrinutost.
English: Horse Allo 20 was developed as a novel therapy medicine containing cells that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Croatian: Horse Allo 20 razvijen je kao novi lijek za terapiju koji sadržava stanice koje su izmijenjene kako bi se mogle primijeniti za popravak, regeneraciju ili zamjenu tkiva.
English: This was expected to help control the inflammation and joint damage associated with osteoarthritis in horses, and so reduce lameness.
Croatian: Očekivalo se da će to pomoći u kontroli upale i oštećenja zglobova povezanih s osteoartritisom u konja te da će se time smanjiti hromost.
English: The applicant presented data from a field study involving horses from 2 years of age with osteoarthritis, where 37 horses were treated with Horse Allo 20 while 33 horses received a dummy treatment.
Croatian: Podnositelj zahtjeva dostavio je podatke iz terenskog ispitivanja koje je obuhvatilo konje u dobi od dvije i više godina s osteoartritisom, pri čemu je 37 konja liječeno VMP-om Horse Allo 20, dok su 33 konja primila slijepo liječenje.
English: The CVMP was therefore of the opinion that the benefits of Horse Allo 20 did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je CVMP smatrao da koristi VMP-a Horse Allo 20 ne nadmašuju s njim povezane rizike te je preporučio odbijanje odobrenja za stavljanje VMP-a u promet.
English: Horse Allo 20 was expected to be used to treat lameness in adult horses with osteoarthritis.
Croatian: Horse Allo 20 trebao se koristiti za liječenje hromosti odraslih konja s osteoartritisom.
English: On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Horse Allo 20, intended for the treatment of lameness in adult horses with osteoarthritis.
Croatian: Odbor za veterinarsko-medicinske proizvode (Committee for Medicinal Products for Veterinary Use - CVMP) donio je negativno mišljenje i preporučio odbijanje izdavanja odobrenja za stavljanje u promet VMP-a Horse Allo 20, koji je namijenjen liječenju hromosti odraslih konja s osteoartritisom.
English: Horse Allo 20 is a veterinary medicine that contains allogeneic equine mesenchymal stem cells as active substance.
Croatian: Horse Allo 20 je veterinarsko-medicinski proizvod koji sadržava alogene konjske mezenhimalne matične stanice kao djelatnu tvar.
English: How does Horse Allo 20 work?
Croatian: Kako djeluje Horse Allo 20?
English: On 24 January 2019, the CVMP revised part of its opinion but confirmed its recommendation to refuse the marketing authorisation.
Croatian: CVMP je revidirao dio svojeg mišljenja, ali je potvrdio svoju preporuku o odbijanju izdavanja odobrenja za stavljanje VMP-a u promet.
English: What was Horse Allo 20 expected to be used for?
Croatian: Za što se VMP Horse Allo 20 trebao koristiti?
English: The full EPAR for Betmiga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Betmiga nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: ‘Prolonged-release' means that mirabegron is released slowly from the tablet over a few hours.
Croatian: „Produljeno oslobađanje” znači da se mirabegron polako otpušta iz tablete tijekom nekoliko sati.
English: Betmiga must not be used in people who have hypertension (high blood pressure) that is severe and uncontrolled.
Croatian: Betmiga se ne smije koristiti u osoba koje imaju hipertenziju (visoki krvni tlak), a koja je ozbiljna i nekontrolirana.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Betmiga on 20 December 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Betmiga na snazi u Europskoj uniji od 20. prosinca 2012.
English: It is available as prolonged-release tablets (25 mg, 50 mg).
Croatian: Dostupan je u obliku tableta s produljenim oslobađanjem (25 mg, 50 mg).
English: Serious but uncommon side effects include atrial fibrillation (cardiac rhythm disorder).
Croatian: Ozbiljne no manje česte nuspojave uključuju fibrilaciju atrija (poremećaj srčanog ritma).
English: The main measure of effectiveness was the change in the number of urinations and incontinence episodes per day after 3 months of treatment.
Croatian: Glavno mjerilo djelotvornosti bila je promjena broja epizoda uriniranja i inkontinencije dnevno nakon 3 mjeseca terapije.
English: Patients received Betmiga (25 mg, 50 mg or 100 mg) or placebo (a dummy treatment) every day for 3 months.
Croatian: Bolesnici su primili lijek Betmiga (25 mg, 50 mg ili 100 mg) ili placebo (lažno liječenje) svaki dan tijekom 3 mjeseca.
English: The recommended dose of Betmiga is 50 mg once a day.
Croatian: Preporučena doza lijeka Betmiga je 50 mg jednom na dan.
English: In patients who have reduced kidney or liver function the doctor may need to prescribe a lower dose or avoid the use of Betmiga, especially in patients taking certain other medicines.
Croatian: U bolesnika koji imaju smanjenu funkciju bubrega ili jetre liječnik će možda trebati propisati manju dozu ili izbjegavati primjenu lijeka Betmiga, posebice u bolesnika koji uzimaju određene druge lijekove.
English: It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt).
Croatian: Koristi se za liječenje određenih simptoma stanja: urgencije (iznenadne potrebe za uriniranjem), povećane učestalosti mokrenja (potrebe za čestim uriniranjem) i urgentne inkontinencije (nevoljnim curenjem urina iz mjehura kada se osjeti snažna potreba za uriniranjem).
English: Experimental studies have shown that, when activated, beta-3 receptors cause the bladder muscles to relax.
Croatian: Eksperimentalna ispitivanja pokazala su da, kada se aktiviraju, beta-3-receptori uzrokuju opuštanje mišića mjehura.
English: What measures are being taken to ensure the safe and effective use of Betmiga?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Betmiga?
English: This is a summary of the European public assessment report (EPAR) for Betmiga.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Betmiga.
English: Other information about Betmiga
Croatian: Ostale informacije o lijeku Betmiga
English: This is thought to lead to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions and thus fewer unwanted urinations.
Croatian: Smatra se da to uzrokuje povećanje kapaciteta mjehura i promjene u načinu kontrakcije mjehura, što rezultira manjim brojem kontrakcija mjehura te stoga i manjim brojem neželjenih uriniranja.
English: Regarding its safety, most side effects are comparable to those of other medicines used for treating overactive bladder syndrome.
Croatian: S obzirom na sigurnost primjene lijeka, većina nuspojava bila je usporediva s onima drugih lijekova koji se koriste za liječenje sindroma prekomjerno aktivnog mokraćnog mjehura.
English: The most common side effects with Betmiga are tachycardia (rapid heartbeat) seen in just over 1 person in 100, and urinary tract infection (infection of the structures that carry urine) seen in just under 3 people in 100.
Croatian: Najčešće nuspojave lijeka Betmiga su tahikardija (ubrzani otkucaji srca), uočena u malo više od 1 osobe na 100, i infekcija urinarnog trakta (infekcija putova kojima se provodi urin), uočena u malo manje od 3 osobe na 100.
English: Betmiga has been studied in three main studies involving 4,611 patients with overactive bladder syndrome.
Croatian: Betmiga je ispitivan u tri glavna ispitivanja koja su obuhvatila 4 611 bolesnika sa sindromom prekomjerno aktivnog mokraćnog mjehura.