FrancophonIA/ELRC3.0 huggingface dataset:
English: - Effects in the eye: eye surface inflammation with or without loss or damage of cells, foreign body sensation in the eyes, eyelid crusting or drooping.
Croatian: • Nuspojave na oku: upala površine oka s ili bez gubitka ili oštećenja stanica, osjećaj stranoga tijela u očima, stvaranje krusti na vjeđi ili obješenost vjeđa.
English: No toxic effects are likely to occur in case of overdose with ocular use, nor in the event of accidental oral ingestion.
Croatian: Malo je vjerojatno da će predoziranje kod okularne primjene, ili kod slučajne oralne ingestije uzrokovati toksično djelovanje.
English: The adverse reactions were obtained from clinical trials or post-marketing reports with NEVANAC 3 mg/ml eye drops, suspension and NEVANAC 1 mg/ml eye drops, suspension.
Croatian: Nuspojave su zabilježene kroz klinička ispitivanja ili kroz iskustvo nakon stavljanja u promet lijeka NEVANAC 3 mg/ml kapi za oko, suspenzija i NEVANAC 1 mg/ml kapi za oko, suspenzija.
English: Do not use a double dose to make up for the 1 missed.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu.
English: Mannitol E421, carbomer, sodium chloride, tyloxapol, disodium edetate, benzalkonium chloride, sodium hydroxide and/or hydrochloric acid and purified water.
Croatian: Manitol E421, karbomer, natrijev klorid, tiloksapol, dinatrijev edetat, benzalkonijev klorid, natrijev hidroksid i/ili kloridna kiselina i pročišćena voda.
English: The most frequently reported adverse reaction was punctate keratitis which occurred in 3% of patients, resulting in a frequency category of common.
Croatian: Najčešće zabilježena nuspojava bio je punktiformni keratitis koji se pojavio u 3% bolesnika, što je rezultiralo svrstavanjem unutar kategorije učesatalosti često.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE VREĆICA
English: The following side effects have also been observed with NEVANAC 1 mg/ml eye drops, suspension or NEVANAC 3 mg/ml eye drops, suspension, or both.
Croatian: Sljedeće su nuspojave također zabilježene s NEVANAC 1 mg/ml kapi za oko, suspenzijom ili NEVANAC 3 mg/ml kapi za oko, suspenzijom, ili s obje:
English: Each ml of suspension contains 0.05 mg of benzalkonium chloride.
Croatian: Pomoćna tvar s poznatim učinkom Svaki ml suspenzije sadrži 0,05 mg benzalkonijeva klorida.
English: Boric acid, propylene glycol, carbomer, sodium chloride, guar, carmellose sodium, disodium edetate, benzalkonium chloride, sodium hydroxide and/or hydrochloric acid and purified water.
Croatian: Boratna kiselina, propilenglikol, karbomer, natrijev klorid, gvar, karmelozanatrij, dinatrijev edetat, benzalkonijev klorid, natrijev hidroksid i/ili kloridna kiselina i pročišćena voda.
English: After oral administration of
Croatian: Nakon peroralne primjene
English: Prevention and treatment of postoperative pain and inflammation associated with cataract surgery Three pivotal studies were conducted to assess the efficacy and safety of NEVANAC dosed 3 times daily as compared to vehicle and/or ketorolac trometamol in the prevention and treatment of postoperative pain and inflammation in patients undergoing cataract surgery.
Croatian: Provedena su tri pivotalna ispitivanja za ocjenu djelotvornosti i sigurnosti NEVANAC-a koji je doziran 3 puta dnevno, u usporedbi s podlogom lijeka i/ili ketorolak trometamolom za prevenciju i liječenje postoperativne boli i upale u bolesnika koji su pripremani za operaciju katarakte.
English: - Prevention and treatment of postoperative pain and inflammation associated with cataract surgery - Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients (see section 5.1)
Croatian: - Smanjenje rizika od postoperativnog makularnog edema povezanog s operacijom katarakte kod bolesnika s dijabetesom (vidjeti dio 5.1)
English: • Effects in the eye: damage of the surface of the eye such as thinning or perforation, impaired healing of the eye, eye surface scar, clouding, reduced vision, eye swelling, blurred vision.
Croatian: • Nuspojave na oku: oštećenje površine oka kao što je stanjivanje ili perforacija, usporeno zacjeljivanje oka, ožiljak na površini oka, zamagljenje, smanjeni vid, iritacija oka, oticanje oka, zamagljen vid.
English: The following side effects have been observed with NEVANAC 3 mg/ml eye drops, suspension or NEVANAC 1 mg/ml eye drops, suspension or both.
Croatian: Sljedeće su nuspojave zabilježene s NEVANAC 3 mg/ml kapi za oko, suspenzijom i NEVANAC 1 mg/ml kapi za oko, suspenzijom ili obje:
English: - The other ingredients are boric acid, propylene glycol, carbomer, sodium chloride, guar, carmellose sodium, disodium edetate, benzalkonium chloride (see section 2) and purified water.
Croatian: • Drugi sastojci su boratna kiselina, propileglikol, karbomer, natrijev klorid, gvar, karmelozanatrij, dinatrijev edetat, benzalkonijev klorid (vidjeti dio 2) i pročišćena voda.
English: Write the date of opening on the carton label in the space provided.
Croatian: Na kutiji u predviđeni prostor napišite datum kada ste je otvorili.
English: Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening.
Croatian: Postmarketinško iskustvo s topikalnim NSAIL-ima sugerira da bolesnici s kompliciranim operacijama na oku, denervacijom rožnice, defektima epitela rožnice, dijabetes melitusom, bolestima površine oka (npr. sindrom suhoga oka), reumatoidnim artritisom ili oni koji u kratkom vremenskom razdoblju imaju nekoliko kirurških zahvata na oku, mogu biti izloženi povećanom riziku od nuspojava na rožnici, koje mogu ugroziti vid.
English: What NEVANAC looks like and the contents of the pack NEVANAC is a liquid (light yellow to light orange suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap.
Croatian: NEVANAC je tekućina (svijetložuta do svijetlonarančasta suspenzija) dostupna u pakiranju koje sadrži jednu plastičnu bočicu od 5 ml sa zatvaračem s navojem.
English: C-nepafenac.
Croatian: diklofenak.
English: Not known: corneal perforation, impaired healing (cornea), corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision
Croatian: Nepoznato: perforacija rožnice, usporeno zacjeljivanje (rožnica), zamućenje rožnice, ožiljak rožnice, smanjena oštrina vida, oticanje oka, ulcerozni keratitis, stanjenje rožnice, zamagljen vid
English: - General side effects: dizziness, headache, allergic symptoms (eyelid allergic swelling), nausea, skin inflammation, redness and itching.
Croatian: • Opće nuspojave: omaglica, glavobolja, simptomi alergije (alergijsko oticanje vjeđa), mučnina,
English: After cap is removed, if a tamper evident snap collar is present and is loose, remove before using product.
Croatian: Nakon skidanja zatvarača, ukoliko postoji zaštitni obruč s evidencijom otvaranja i klimav je, uklonite ga prije primjene lijeka.
English: • Effects in the eye: iris inflammation, eye pain, eye discomfort, dry eye, eyelid swelling, eye irritation, itchy eye, eye discharge, allergic conjunctivitis (eye allergy), increased tear production, deposits on the eye surface, fluid or swelling at the back of the eye, eye redness.
Croatian: • Nuspojave na oku: upala šarenice, bol u oku, nelagoda u oku, suho oko, oticanje vjeđa, iritacija oka, svrbež oka, iscjedak iz oka, alergijski konjunktivitis (alergija oka), pojačano stvaranje suza, depoziti na površini oka, tekućina ili oticanje u stražnjem dijelu oka, crvenilo oka.
English: • Shake well before use.
Croatian: • Dobro protresite prije primjene.
English: For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period.
Croatian: Za prevenciju i liječenje boli i upale, doza je 1 kap NEVANAC-a u konjunktivalnu vrećicu zahvaćenoga oka (očiju) 3 puta dnevno, a primjena započinje 1 dan prije operacije katarakte, nastavlja se na dan operacije i tijekom prva 2 tjedna nakon operacije.
English: For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) once daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician.
Croatian: Za smanjenje rizika od postoperativnog makularnog edema povezanog sa operacijom katarakte kod bolesnika s dijabetesom, doza je 1 kap NEVANAC-a u konjunktivalnu vrećicu zahvaćenoga oka (očiju) jedan puta dnevno, a primjena započinje 1 dan prije operacije katarakte, nastavlja se na dan operacije i do 60 dana nakon operacije, prema uputama liječnika.
English: Rare: iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia
Croatian: Rijetko: iritis, efuzija žilnice, depoziti na rožnici, bol u oku, nelagoda u oku, suho oko, blefaritis, iritacija oka, svrbež oka, iscjedak iz oka, alergijski konjunktivitis, pojačano suzenje, hiperemija konjuktive
English: For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician.
Croatian: Za smanjenje rizika od postoperativnog makularnog edema povezanog sa operacijom katarakte kod bolesnika s dijabetesom, doza je 1 kap NEVANAC-a u konjunktivalnu vrećicu zahvaćenoga oka (očiju) 3 puta dnevno, a primjena započinje 1 dan prije operacije katarakte, nastavlja se na dan operacije i do 60 dana nakon operacije, prema uputama liječnika.
English: Manufacturer S.A. Alcon - Couvreur N.V Rijksweg 14
Croatian: S.A. Alcon Couvreur N.V.
English: For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) once a day beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period.
Croatian: Za prevenciju i liječenje boli i upale, doza je 1 kap NEVANAC-a u konjunktivalnu vrećicu zahvaćenoga oka (očiju) jedan puta dnevno, a primjena započinje 1 dan prije operacije katarakte, nastavlja se na dan operacije i tijekom prva 2 tjedna nakon operacije.
English: NEVANAC can be used during breast-feeding.
Croatian: NEVANAC se može primijeniti tijekom dojenja.
English: • After cap is removed, if tamper evident snap collar is loose, remove before using product.
Croatian: • Nakon skidanja zatvarača, ukoliko je zaštitni obruč s evidencijom otvaranja klimav, uklonite ga prije primjene lijeka.
English: After cap is removed, if tamper evident snap collar is loose, remove before using product.
Croatian: Nakon skidanja zatvarača, ukoliko je zaštitni obruč s evidencijom otvaranja klimav, uklonite ga prije primjene lijeka.
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien Novartis Pharma N.V.
English: NEVANAC 3 mg/ml eye drops, suspension
Croatian: NEVANAC 3 mg/ml kapi za oko, suspenzija
English: NEVANAC 1 mg/ml eye drops, suspension nepafenac
Croatian: NEVANAC 1 mg/ml kapi za oko, suspenzija nepafenak
English: NEVANAC 3 mg/ml eye drops, suspension nepafenac
Croatian: NEVANAC 3 mg/ml kapi za oko, suspenzija nepafenak
English: Novartis Pharma N.V.
Croatian: Nederland Novartis Pharma B.V.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: 1 ml of suspension contains 3 mg nepafenac.
Croatian: 1 ml suspenzije sadrži 3 mg nepafenaka.
English: NEVANAC 1 mg/ml eye drops, suspension
Croatian: NEVANAC 1 mg/ml kapi za oko, suspenzija
English: - complicated eye surgery - repeated eye surgery within a short period of time - certain disorders of the surface of the eye, such as inflammation or dry eye - certain general diseases, such as diabetes or rheumatoid arthritis.
Croatian: Rizik od pojave nuspojava na rožnici (problemi površine oka) može biti povećan, ako ste imali - komplicirani kirurški zahvat na oku - više kirurških zahvata na oku u kratkom vremenskom razdoblju - određene poremećaje površine oka, kao što su upala ili suho oko - određene opće bolesti, kao što su šećerna bolest ili reumatoidni artritis.
English: What NEVANAC contains - The active substance is nepafenac.
Croatian: • Djelatna tvar je nepafenak.
English: NEVANAC is to be used by adults: - To prevent and relieve eye pain and inflammation following cataract surgery on the eye. - To reduce the risk of macular oedema (swelling in the back of the eye) following cataract surgery on the eye in diabetic patients.
Croatian: NEVANAC se koristi u odraslih osoba: - za sprječavanje i ublažavanje boli u oku i upale nakon operacije mrene na oku.
English: Do not store above 30˚C.
Croatian: Ne čuvati na temperaturi iznad 30ºC.
English: Do not store above 25˚C.
Croatian: Ne čuvati na temperaturi iznad 25ºC.
English: - If you get any side effects talk to your doctor, pharmacist or nurse.
Croatian: - Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: NEVANAC 3 mg/ml eye drops nepafenac
Croatian: NEVANAC 3 mg/ml kapi za oko nepafenak
English: 1 ml of suspension contains 1 mg nepafenac.
Croatian: 1 ml suspenzije sadrži 1 mg nepafenaka.
English: Guar
Croatian: Nuspojave
English: NEVANAC 1 mg/ml eye drops nepafenac
Croatian: NEVANAC 1 mg/ml kapi za oko nepafenak
English: One ml of suspension contains 3 mg of nepafenac.
Croatian: Jedan ml suspenzije sadrži 3 mg nepafenaka.
English: One ml of suspension contains 1 mg of nepafenac.
Croatian: Jedan ml suspenzije sadrži 1 mg nepafenaka.
English: • Effects in the eye: eye surface inflammation with or without loss or damage of cells, foreign body sensation in the eyes, eyelid crusting or drooping.
Croatian: • Nuspojave na oku: upala površine oka s ili bez gubitka ili oštećenja stanica, osjećaj stranoga tijela u očima, stvaranje krusti na vjeđi ili obješenost vjeđa, Rijetke nuspojave (mogu se pojaviti u do 1 na 1000 osoba)
English: Nasonex medicinal products are registered in the following EU Members States: Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom and also in Iceland and Norway.
Croatian: Lijekovi Nasonex registrirani su u sljedećim državama članicama EU: Austriji, Belgiji, Bugarskoj, Češkoj Republici, Danskoj, Estoniji, Finskoj, Francuskoj, Njemačkoj, Grčkoj, Mađarskoj, Irskoj, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemskoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji, Španjolskoj, Švedskoj i Ujedinjenoj Kraljevini, te na Islandu i u Norveškoj.
English: Nasonex medicinal products are currently not registered in Cyprus.
Croatian: Lijekovi Nasonex trenutačno nisu odobreni na Cipru.
English: The safety and efficacy of Nasonex Nasal Spray has not been established in:
Croatian: Sigurnost i djelotvornost Nasonex nosnog spreja nije utvrđena u:
English: It was authorised according to the national procedure in 16 European countries and according to the mutual recognition procedure (MRP) in 13 Member States, with the United Kingdom (UK) acting as reference Member State (RMS).
Croatian: Odobren je u skladu s nacionalnim postupkom u 16 europskih država i u skladu s postupkom međusobnog priznavanja (MRP-om) u 13 država članica, pri čemu je Ujedinjena Kraljevina (UK) djelovala kao referentna država članica (RMS).
English: - children and adolescents under 18 years of age have not been established in nasal polyposis.
Croatian: - djece i adolescenata mlađih od 18 godina, u kojih nisu utvrđena nosna polipoza.
English: Perennial rhinitis
Croatian: Perenijalni rinitis
English: A cross reference to section 4.4 for use with systemic corticosteroids is made.
Croatian: Navedena je unakrsna referenca na dio 4.4 za primjenu sa sistemskim kortikosteroidima.
English: The text in section 4.2 has been revised and aligned with the QRD requirements.
Croatian: Tekst u dijelu 4.2 je pregledan i usklađen sa zahtjevima QRD-a.
English: The mean scores for physician evaluations of total nasal symptoms showed greater reductions for mometasone furoate at all visits (ranging from 36 to 62%) compared to placebo (22% to 48%).
Croatian: Srednji rezultati za ocjene liječnika ukupnih nazalnih simptoma pokazali su veće smanjenje za mometazon furoat u svim posjetima (u rasponu od 36 do 62 %) u usporedbi s placebom (22 % do 48 %).
English: It is stated that overdose is unlikely to require any therapy other than observation since the systemic bioavailability of mometasone furoate is <1%.
Croatian: Navedeno je kako nije vjerojatno da predoziranje zahtijeva bilo kakvu terapiju osim praćenja budući da je sistemska bioraspoloživost mometazona furoata <1 %.
English: The higher incidence of epitaxis observed in clinical studies is also mentioned in this section as well as in section 4.8.
Croatian: Veća incidencija epitakse uočena u kliničkim ispitivanjima također se navodi u ovom dijelu kao i u dijelu 4.8.
English: Thus there is support for efficacy in the age group 3-5 years, and no difference in efficacy is to be expected in a 3 year old as compared to a 6 year old from a pharmacological perspective.
Croatian: Stoga, postoji podrška djelotvornosti u starosnoj skupini trogodišnjaka do petogodišnjaka, te se ne očekuju razlike u djelotvornosti u trogodišnjaka u usporedbi sa šestogodišnjacima s farmakološkog stajališta.
English: The adverse events were presented independently of the indication and presenting all data (pooled) in a single tabulated format.
Croatian: Nuspojave su navedene neovisno o indikacijama i predstavljaju sve podatke (sažete) u jednom tabličnom formatu.
English: Treatment of acute sinusitis
Croatian: Liječenje akutnog sinusitisa
English: Subsequently, a study Q97-921 specifically in subjects with perennial non-allergic rhinitis (PNAR) was completed indicating a positive outcome, and resulting in an indication for PNAR being granted in May 2000 in Sweden.
Croatian: Posljedično, ispitivanje Q97-921 posebice u subjekata s perenijalnim nealergijskim rinitisom (PNAR) završeno je ukazujući na pozitivan ishod, što je rezultiralo odobravanjem u indikaciji PNARa u svibnju 2000. u Švedskoj.
English: However inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
Croatian: No, inhalacija ili oralna primjena prekomjernih doza kortikosteroida može rezultirati supresijom funkcije HPA osi.
English: Mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic or antiestrogenic activity.
Croatian: Mometazon furoat nema androgeno, antiandrogeno, estrogeno ili antiestrogeno djelovanje.
English: The information proposed by the MAH in this section of the SmPC was listed under the headings absorption, distribution, biotransformation and elimination, and was considered to be acceptable by the CHMP, with the recommended amendments.
Croatian: Informacije koje je predložio nositelj odobrenja u ovom dijelu SmPC-a navedene su u poglavljima o apsorpciji, distribuciji, biotransformaciji i eliminaciji, te ih CHMP smatra prihvatljivima, uz preporučene izmjene.
English: Mometasone furoate is not recommended for use in case of nasal septum perforation (the reported instances of nasal septum perforation information is mentioned in section 4.8).
Croatian: Mometazon furoat se ne preporučuje za primjenu u slučaju perforacije septuma nosa (prijavljeni slučajevi informacija u vezi s perforacijom septuma nosa navode se u dijelu 4.8).
English: Mention is made of the immunosuppressive effects of corticosteroids and the risk of exposure of patients to certain infections (e.g., chickenpox, measles), and of the importance of obtaining medical advice if such exposure occurs.
Croatian: Spominje se imunosupresivno djelovanje kortikosteroida i rizik od izlaganja bolesnika određenim infekcijama (primjerice vodnim kozicama, ospicama), kao i važnost dobivanja liječničkog savjeta ako takvo izlaganje nastupi.
English: The section on ‘Fertility' was amended to include only the relevant conclusions from non-clinical toxicity studies in accordance with current Guideline on the summary of product characteristics.
Croatian: Dio „Plodnost” izmijenjen je kako bi obuhvatio samo relevantne zaključke iz nekliničkih ispitivanja toksičnosti u skladu s aktualnim smjernicama o sažetku opisa svojstava.
English: The need for concomitant use of appropriate additional therapy for additional relief of non-nasal symptoms, particularly ocular symptoms, is also highlighted.
Croatian: Naglašena je potreba za istovremenom primjenom primjerene dodatne terapije za dodatno ublažavanje nenosnih simptoma, posebice simptoma očiju.
English: Of the 6 studies, 4 were pooled, and the patient diary results showed a reduction from baseline of 33% compared to 15% in placebo-treated patients in the first 2 weeks of treatment with mometasone furoate.
Croatian: Od 6 ispitivanja, 4 su bila združena, a rezultati dnevnika bolesnika potvrdili su smanjenje u osnovnoj vrijednosti od 33 % u usporedbi s 15 % u bolesnika liječenih placebom u prva 2 tjedna liječenja mometazon furoatom.
English: On the basis of 19 Phase II and III studies completed using mometasone furoate in adolescents and adults, a total dose 200 µg once daily was chosen as the standard clinical adolescent/adult dosage, allowing dose titration up to a maximum daily total dose of 400 mg.
Croatian: Na temelju 19 ispitivanja faze II. i III. završenih primjenom mometazon furoata u adolescenata i odraslih osoba, odabrana je ukupna doza od 200 µg jednom dnevno kao standardna klinička doza u adolescenata/odraslih osoba, čime se dozvoljava titranje doze do maksimalne dnevne doze od 400 µg.
English: Six studies were conducted to demonstrate the efficacy of mometasone furoate in 2544 patients with seasonal allergic rhinitis randomised to treatment with mometasone furoate, placebo or active control.
Croatian: Provedeno je šest ispitivanja kako bi se dokazala djelotvornost mometazon furoata u 2544 bolesnika sa sezonskim alergijskim rinitisom randomiziranih za liječenje mometazon furoatom, placebom ili aktivnom kontrolom.
English: These studies support the proposed indication for the symptomatic treatment of rhinitis (seasonal allergic and perennial) in adults.
Croatian: Ta ispitivanja podržavaju predloženu indikaciju za simptomatično liječenje rinitisa (sezonskog alergijskog i perenijalnog) u odraslih osoba.
English: Summary of product characteristics (SmPC)
Croatian: Sažetak opisa svojstava lijeka (SmPC)
English: Two studies investigating sinusitis and also the results and analysis of an additional study (A2-3852) conducted to assess the clinical relevance of the observed effect size of the treatment showed that the clinical relevance of the data generated in these studies with respect to the indication proposed had not been established.
Croatian: Dva ispitivanja, koja su istraživala sinusitis kao i rezultate i analizu dodatnog ispitivanja (A2-3852), provedena kako bi se ocijenila klinička relevantnost uočenog razmjera djelovanja liječenja, potvrdila su da nije utvrđena klinička relevantnost podataka generiranih u ovim ispitivanjima u odnosu na predloženu indikaciju.