FrancophonIA/ELRC3.0 huggingface dataset:
English: This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Croatian: To odgovara odmjerenoj dozi od 100 mikrograma flutikazonfuroata i 25 mikrograma vilanterola (u obliku trifenatata).
English: HZC112207 evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=204] and fluticasone furoate/vilanterol 184/22 micrograms [n=205] compared with FF 92 micrograms [n=204], FF 184 micrograms [n=203] and vilanterol 22 micrograms [n=203] and placebo [n = 205], all administered once daily.
Croatian: Ispitivanjem HZC112207 ocjenjivala se djelotvornost flutikazonfuroata/vilanterola od 92/22 mikrograma [n=204] i flutikazonfuroata/vilanterola od 184/22 mikrograma [n=205] u odnosu na flutikazonfuroat od 92 mikrograma [n=204], flutikazonfuroat od 184 mikrograma [n=203] i vilanterol od 22 mikrograma [n=203] te placebo [n = 205] (svi su se primjenjivali jedanput na dan).
English: The tray contains a desiccant sachet, to reduce moisture.
Croatian: Podložak sadrži vrećicu sa sredstvom za sušenje radi smanjenja količine vlage.
English: - For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Croatian: - Doza od 92/22 μg: jedna pojedinačna inhalacija daje primijenjenu dozu (doza koja izlazi iz nastavka za usta) od 92 mikrograma flutikazonfuroata i 22 mikrograma vilanterola (u obliku trifenatata).
English: Finally, the exposure-adjusted cases of fatal pneumonia were 8.8 for FF/VI 184/22 versus 1.5 for FF/VI 92/22 and 0 for VI 22.
Croatian: Naposljetku, incidencija pneumonije sa smrtnim ishodom prilagođena s obzirom na izloženost iznosila je 8,8 za flutikazonfuroat/vilanterol od 184/22 mikrograma u usporedbi s 1,5 za flutikazonfuroat/vilanterol od 92/22 mikrograma te 0 za vilanterol od 22 mikrograma.
English: In a 12 week study (HZC113107) in COPD patients both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the morning and salmeterol/FP 50/500 micrograms given twice daily, demonstrated improvements from baseline in lung function.
Croatian: U 12-tjednom ispitivanju bolesnika s KOPB-om i flutikazonfuroat/vilanterol od 92/22 mikrograma jedanput na dan ujutro i salmeterol/flutikazonpropionat 50/500 mikrograma dvaput na dan doveli su do poboljšanja plućne funkcije u odnosu na početnu vrijednost.
English: Change from baseline in the percentage of rescue-free 24 hour periods during treatment was a powered secondary endpoint.
Croatian: Promjena od početnog postotka 24-satnih razdoblja bez primjene terapije za olakšanje simptoma tijekom liječenja bila je sekundarna mjera ishoda sa statističkom snagom.
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Croatian: Pri sustavnoj i topikalnoj uporabi kortikosteroida moguća je pojava poremećaja vida.
English: Studies HZC102970 and HZC102871 were 52 week randomised, double-blind, parallel-group, studies comparing the effect of fluticasone furoate/vilanterol 184/22 micrograms, fluticasone furoate/vilanterol 92/22 micrograms, fluticasone furoate/vilanterol 46/22 micrograms with vilanterol 22 micrograms, all administered once daily, on the annual rate of moderate/severe exacerbations in subjects with COPD with a smoking history of at least 10 pack years and a post-salbutamol FEV1/FVC ratio less than or equal to 0.70 and post-salbutamol FEV1 less than or equal to 70% predicted and documented history of ≥ 1 COPD exacerbation that required antibiotics and/or oral corticosteroids or hospitalisation in the 12 months prior to visit 1.
Croatian: 184/22 mikrograma, flutikazonfuroata/vilanterola od 92/22 mikrograma i flutikazonfuroata/vilanterola od 46/22 mikrograma s vilanterolom od 22 mikrograma (svi su se primjenjivali jedanput na dan) na godišnju stopu umjerenih/teških egzacerbacija u ispitanika s KOPB-om koji su bili pušači sa stažem od najmanje 10 kutija-godina i koji su imali omjer FEV1/FVC nakon uzimanja salbutamola od najviše
English: HZA106827 was 12 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=201] and FF 92 micrograms [n=205]) compared with placebo [n=203], all administered once daily.
Croatian: Ispitivanje HZA106827 trajalo je 12 tjedana, a njime se ocjenjivala djelotvornost flutikazonfuroata/vilanterola od 92/22 mikrograma [n=201] i flutikazonfuroata od 92 mikrograma [n=205] u usporedbi s placebom [n=203] (svi su se primjenjivali jedanput na dan).
English: The device does not need to be stored in the foil laminate tray once it has been opened.
Croatian: Uređaj se nakon otvaranja ne mora čuvati u podlošku od višeslojne folije.
English: • While holding the inhaler away from your mouth, breathe out as far as is comfortable.
Croatian: • Držite inhalator dalje od usta i izdahnite koliko možete, do granice neugode.
English: Vision blurred (see section 4.4)
Croatian: Poremećaji oka zamućen vid (vidjeti dio 4.4.)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 184/22 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA - SAMO VIŠESTRUKO PAKIRANJE) 184/22 mikrograma
English: The incidence of pneumonia in patients with asthma taking fluticasone furoate/vilanterol 184/22 micrograms was numerically higher compared with those receiving fluticasone furoate/vilanterol 92/22 micrograms or placebo (see section 4.8).
Croatian: Incidencija pneumonije u bolesnika s astmom koji su uzimali flutikazonfuroat/vilanterol od 184/22 mikrograma bila je brojčano veća u odnosu na bolesnike koji su uzimali flutikazonfuroat/vilanterol od
English: FF and FP both increased the percentage of 24 hour rescue free periods by 14.8% (95% CI 6.9, 22.7, p<0.001) and 17.9% (95% CI 10.0, 25.7, p<0.001) respectively versus placebo.
Croatian: Primjena flutikazonfuroata povećala je postotak 24-satnih razdoblja bez terapije za 14,8% (95% CI 6,9; 22,7, p<0,001), a primjena flutikazonpropionata za 17,9% (95% CI 10,0; 25,7, p<0,001) u odnosu na placebo.
English: Asthma-related adverse events and exacerbations may occur during treatment with fluticasone furoate/vilanterol.
Croatian: Tijekom liječenja flutikazonfuroatom/vilanterolom može doći do nuspojava i egzacerbacija povezanih s astmom.
English: • Put the mouthpiece between your lips, and close your lips firmly around it. Don't block the air vent with your fingers.
Croatian: • Stavite nastavak za usta među usne i čvrsto ga obujmite usnama.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 92/22 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA - SAMO VIŠESTRUKO PAKIRANJE) 92/22 mikrograma
English: Each delivered dose contains 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Croatian: Jedna primijenjena doza sadrži 92 mikrograma flutikazonfuroata i 22 mikrograma vilanterola (u obliku trifenatata).
English: There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females).
Croatian: Na temelju farmakokinetičke analize podataka iz ispitivanja faze III, u kojima je sudjelovalo 1213 ispitanika sa astmom (712 žena), nema dokaza da spol, tjelesna težina ili ITM (indeks tjelesne mase) utječu na farmakokinetiku flutikazonfuroata.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Croatian: Jedna pojedinačna inhalacija daje primijenjenu dozu (doza koja izlazi iz nastavka za usta) od 92 mikrograma flutikazonfuroata i 22 mikrograma vilanterola (u obliku trifenatata).
English: There was no evidence for gender, weight or BMI (body mass index) to influence the pharmacokinetics of fluticasone furoate based on a population pharmacokinetic analysis of phase III data in 1213 subjects with asthma (712 females) and 1225 subjects with COPD (392 females).
Croatian: Na temelju farmakokinetičke analize podataka iz ispitivanja faze III, u kojima je sudjelovalo 1213 ispitanika sa astmom (712 žena) i 1225 ispitanika s KOPB-om (392 žena), nema dokaza da spol,
English: For severe pneumonia the corresponding number of events per 1000 patient years were 33.6, 35.5, and 7.6 respectively, while for serious pneumonia the corresponding events per 1000 patient years were 35.1 for FF/VI 184/22, 42.9 with FF/VI 92/22, 12.1 with VI 22.
Croatian: Broj događaja teške pneumonije na 1000 bolesnik-godina iznosio je 33,6 za flutikazonfuroat/vilanterol od 184/22 mikrograma, 35,5 za flutikazonfuroat/vilanterol od 92/22 mikrograma i 7,6 za vilanterol od 22 mikrograma, dok je broj događaja ozbiljne pneumonije iznosio 35,1 za flutikazonfuroat/vilanterol od 184/22 mikrograma, 42,9 za flutikazonfuroat/vilanterol od 92/22 mikrograma te 12,1 za vilanterol od 22 mikrograma.
English: Three phase III randomised, double-blind studies (HZA106827, HZA106829 and HZA106837) of different durations evaluated the safety and efficacy of fluticasone furoate/vilanterol in adult and adolescent patients with persistent asthma.
Croatian: U tri randomizirana, dvostruko slijepa ispitivanja faze III (HZA106827, HZA106829 i HZA106837)
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane hiperglikemija manje često
English: If you have used more than instructed for a long period of time, it is particularly important that you ask your doctor or pharmacist for advice.
Croatian: iznimno je važno da zatražite savjet svog liječnika ili ljekarnika.
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
Croatian: NAZIV LIJEKA Relvar Ellipta 92 mikrograma/22 mikrograma prašak inhalata, dozirani
English: The risk of the cardiovascular composite event with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.93; 95% CI: 0.75 to 1.14), fluticasone furoate (HR 1.03; 95% CI: 0.83 to 1.28) or vilanterol (HR 0.94; 95% CI: 0.76 to 1.16).
Croatian: flutikazonfuroata (HR: 1,03; 95% CI: 0,83 do 1,28) ili vilanterola (HR: 0,94; 95% CI: 0,76 do 1,16).
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Croatian: NAZIV LIJEKA Relvar Ellipta 184 mikrograma/22 mikrograma prašak inhalata, dozirani
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 92/22 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA OMOTU (S PLAVIM OKVIROM - VIŠESTRUKO PAKIRANJE) 92/22 mikrograma
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 184/22 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA OMOTU (S PLAVIM OKVIROM - VIŠESTRUKO PAKIRANJE) 184/22 mikrograma
English: Fluticasone furoate/vilanterol 92/22 micrograms consistently demonstrated 83 mL to 95 mL improvements in trough FEV1 at weeks 12, 36 and 52 and Endpoint compared with FF 92 micrograms (p<0.001 95% CI 52, 126 mL at Endpoint).
Croatian: Flutikazonfuroat/vilanterol od 92/22 mikrograma dosljedno je pokazivao poboljšanje od 8 ml do 95 ml u najnižoj vrijednosti FEV1 u 12., 36. i 52. tjednu te u trenutku postizanja mjere ishoda, u odnosu na flutikazonfuroat od 92 mikrograma (p<0,001 95% CI 52, 126 ml u trenutku postizanja mjere ishoda).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 92/22 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (POJEDINAČNA PAKIRANJA) 92/22 mikrograma
English: : + 33 (0)1 39 17 84 44 diam@gsk.com
Croatian: Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 diam@gsk.com
English: At Day 169 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean trough FEV1 by 129 mL (95% CI: 91, 167 mL, p<0.001) and 83 mL (95% CI: 46, 121mL, p<0.001) respectively compared to placebo.
Croatian: 92/22 mikrograma povećao je prilagođenu najnižu srednju vrijednost FEV1 za 129 ml (95% CI: 91, 167 ml, p<0,001), a vilanterol za 83 ml (95% CI: 46, 121 ml, p<0,001) u odnosu na placebo.
English: System organ class
Croatian: Klasifikacija organskih sustava Nuspojava(e)
English: Rhinitis
Croatian: Podložak
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 92 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Relvar Ellipta 92 mikrograma/22 mikrograma prašak inhalata flutikazonfuroat/vilanterol
English: Improvements were also seen in this subgroup at week 52 when comparing the fluticasone furoate/vilanterol 92/22 micrograms vs. vilanterol 22 micrograms in adjusted mean trough FEV1 (44 mL 95% CI: 15, 73mL, (p=0.003)).
Croatian: Pri usporedbi flutikazonfuroata/vilanterola od 92/22 mikrograma i vilanterola od 22 mikrograma i u ovoj su podskupini zabilježena poboljšanja prilagođene srednje najniže vrijednosti FEV1 u 52. tjednu (44 ml 95% CI: 15, 73 ml, (p=0,003)).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Relvar Ellipta 184 micrograms/22 micrograms inhalation powder fluticasone furoate/vilanterol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Relvar Ellipta 184 mikrograma/22 mikrograma prašak inhalata flutikazonfuroat/vilanterol
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate the adverse reactions of fluticasone furoate/vilanterol.
Croatian: Simpatomimetički lijekovi Istodobna primjena drugih simpatomimetičkih lijekova (samostalno ili u sklopu kombinirane terapije)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACK) 184/22 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (POJEDINAČNA PAKIRANJA) 184/22 mikrograma
English: Uncommon side effects This may affect up to 1 in 100 people:
Croatian: Rijetke nuspojave Mogu se javiti u do 1 na 1000 osoba
English: Uncommon Rare
Croatian: manje često
English: • itchy, runny or blocked nose
Croatian: • svrbež, curenje ili začepljenost nosa
English: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
Croatian: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 (0) 10 85 52 00
English: While you're using Relvar Ellipta
Croatian: Ako ste zaboravili primijeniti Relvar Ellipta
English: There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females).
Croatian: Na temelju farmakokinetičke analize podataka prikupljenih u 856 ispitanika s astmom (500 žena),
English: The enhanced anti-inflammatory effect of the LABA component was similar to that obtained with other ICS/LABA combinations.
Croatian: Pojačan protuupalni učinak dugodjelujućeg beta2-agonista bio je sličan učinku postignutom primjenom drugih kombinacija inhalacijskog kortikosteroida/dugodjelujućeg beta2-agonista.
English: Fluticasone furoate/vilanterol 92 /22 micrograms consistently demonstrated 83 mL to 95 mL improvements in trough FEV1 at weeks 12, 36 and 52 and Endpoint compared with FF 92 micrograms (p<0.001 95% CI 52, 126 mL at Endpoint).
Croatian: 92/22 mikrograma dosljedno je pokazivao poboljšanje od 8 ml do 95 ml u najnižoj vrijednosti FEV1 u 12., 36. i 52. tjednu te u trenutku postizanja mjere ishoda, u odnosu na flutikazonfuroat od 92 mikrograma (p<0,001 95% CI 52, 126 ml u trenutku postizanja mjere ishoda).
English: In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI
Croatian: U objedinjenoj analizi dvaju replikacijskih jednogodišnjih ispitivanja u bolesnika s umjerenim do teškim KOPB-om (srednja vrijednost FEV1 nakon primjene bronhodilatatora pri probiru bila je 45%
English: Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with fluticasone furoate/vilanterol.
Croatian: Za utvrđivanje učestalosti nuspojava povezanih s flutikazonfuroatom/vilanterolom upotrijebljeni su podaci iz velikih kliničkih ispitivanja u bolesnika s astmom i KOPB-om.
English: These include: beta-blockers, such as metoprolol, used to treat high blood pressure or a heart condition.
Croatian: beta-blokatore, poput metoprolola, koji se koriste za liječenje povišenog krvnog tlaka ili srčanih bolesti ketokonazol, koji se koristi za liječenje gljivičnih infekcija ritonavir ili kobicistat, koji se koristi za liječenje HIV infekcije dugodjelujuće beta-2-adrenergičke agoniste, poput salmeterola.
English: Headache Tremor
Croatian: Česte nuspojave
English: EXPIRY DATE
Croatian: Br. ispitivanja
English: This represents a 25% reduction in the rate of severe asthma exacerbations for subjects treated with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 micrograms(p=0.014).
Croatian: 92/22 mikrograma u odnosu na flutikazonfuroat od 92 mikrograma (p=0,014).
English: Fluticasone furoate monotherapy
Croatian: Monoterapija flutikazonfuroatom
English: Package leaflet: Information for the user Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Croatian: Relvar Ellipta 92 mikrograma/22 mikrograma prašak inhalata, dozirani Relvar Ellipta 184 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/vilanterol
English: Ratio vs VI
Croatian: Omjer naspram VI
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Croatian: Relvar Ellipta 184 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/vilanterol
English: Contents of the pack and other information
Croatian: Kako čuvati Relvar Ellipta 6. Sadržaj pakiranja i druge informacije
English: Magnesium stearate
Croatian: Doziranje Astma
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Croatian: Relvar Ellipta 92 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/vilanterol
English: Do not stop using Relvar Ellipta without advice
Croatian: Nemojte prestati primjenjivati Relvar Ellipta bez prethodnog savjetovanja Primjenjujte ovaj lijek onoliko dugo koliko Vam je liječnik preporučio.
English: In subjects with asthma and subjects with COPD there are no recommended dose modifications.
Croatian: Nema preporuka za prilagođavanje doze u ispitanika s astmom niti u ispitanika s KOPB-om.
English: Change from Baseline in PM Peak Expiratory Flow Treatment difference
Croatian: Promjena u jutarnjem vršnom protoku zraka u ekspiriju prijepodne od početne vrijednosti
English: Desiccant
Croatian: Dojenje
English: Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Croatian: GlaxoSmithKline d.o.o. Tel: + 385 1 6051 999
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/886/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/886/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/886/004
English: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti uključujući anafilaksiju,
English: The step-by-step instructions should be followed.
Croatian: Treba se pridržavati uputa koje opisuju uporabu inhalatora korak po korak.
English: Modified Medical Research Council (mMRC) dyspnea score 2 (scale 0-4) at screening.
Croatian: Promjena početne najniže vrijednosti FEV1 u odnosu na zadnje opažanje preneseno nadalje (LOCF) Terapijska razlika P vrijednost (95% CI)
English: This leaflet
Croatian: Ova uputa
English: Don't use this medicine if you are breastfeeding unless your doctor tells you that you can.
Croatian: osim ako Vam liječnik ne kaže da to smijete učiniti.
English: Blister (alu/Aclar)
Croatian: Blister (Al/Aclar)
English: 84 capsules
Croatian: 84 kapsule
English: Pharmaceutical Form
Croatian: Doza Farmaceutski oblik
English: Capsule, hard
Croatian: 100 mg Kapsula, tvrda Kroz usta
English: EMA Number
Croatian: EMA broj
English: 4 pre-filled syringes
Croatian: 4 napunjene štrcaljke
English: Pack size
Croatian: štrcaljka
English: Content (concent ration)
Croatian: Sastav (koncent racija)
English: MA (EU) number (Invented) Name
Croatian: Broj (EU) odobrenja
English: Package size
Croatian: Veličina pakovanja boce
English: Why was the medicine reviewed?
Croatian: Zašto je lijek preispitivan?
English: What is the outcome of the review?
Croatian: Koji je rezultat preispitivanja?
English: EMA completes review following disagreement among EU Member States
Croatian: EMA je dovršila preispitivanje nakon neslaganja među državama članicama EU-a
English: MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK (the ‘reference Member State') in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain (the ‘concerned Member States').
Croatian: Tvrtka MIKA Pharma GmbH zatražila je da se odobrenje za stavljanje u promet lijeka Diclofenac Sodium Spray Gel 4% koje je 2001. izdala Ujedinjena Kraljevina („referentna država članica”) i koje su nakon toga priznale i Austrija, Estonija, Mađarska, Irska, Latvija, Litva i Slovenija prizna i u Njemačkoj, Italiji i Španjolskoj („predmetne države članice”).
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 4 April 2018.
Croatian: Međutim, države članice nisu uspjele postići dogovor pa je 4. travnja 2018. regulatorna agencija za lijekove Ujedinjene Kraljevine uputila predmet EMA-i na arbitražni postupak.
English: The spray gel is applied on the skin of affected areas to relieve pain and swelling due to trauma in small and medium joints and surrounding tissues.
Croatian: Gel za raspršivanje primjenjuje se na zahvaćenom području kože radi ublažavanja boli i oticanja izazvanih traumom u malim i srednjim zglobovima i okolnim tkivima.
English: The grounds for the referral were concerns raised by Germany and Spain that the data provided by the company were not sufficient to show that the product was effective at treating joint pain and swelling.
Croatian: Razlog za upućivanje na arbitražu bila je zabrinutost Njemačke i Španjolske da podatci koje je tvrtka dostavila nisu dostatni za dokazivanje da je lijek učinkovit u liječenju boli u zglobovima i oticanja.
English: The review of Diclofenac Sodium Spray Gel 4% was initiated at the request of the United Kingdom under Article 29(4) of Directive 2001/83/EC.
Croatian: Preispitivanje lijeka Diclofenac Sodium Spray Gel 4 % pokrenuto je na zahtjev Ujedinjene Kraljevine u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ
English: The Agency concluded that the benefits of the medicine outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Croatian: Agencija je zaključila da koristi od lijeka nadmašuju s njim povezane rizike te da se odobrenje za stavljanje u promet izdano u Ujedinjenoj Kraljevini može priznati u drugim državama članicama EU-a u kojima je tvrtka podnijela zahtjev za stavljanje u promet.
English: What is Diclofenac Sodium Spray Gel 4%?
Croatian: Što je Diclofenac Sodium Spray Gel 4 %?