FrancophonIA/ELRC3.0 huggingface dataset:
English: Maximum total iron serum concentrations were measured 1-2 hours after administration.
Croatian: Najveće ukupne koncentracije željeza u serumu mjerene su 1-2 sata nakon primjene.
English: • Lactose monohydrate (see section 2)
Croatian: • Laktoza hidrat (vidjeti dio 2)
English: Store below 25°C.
Croatian: Čuvati na temperaturi ispod 25C.
English: Impact of Feraccru on absorption of other medicinal products Oral iron is known to reduce the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) moxifloxacin, mycophenolate, norfloxacin and ofloxacin.
Croatian: Pripravci željeza za peroralnu primjenu poznati su po tome što smanjuju apsorpciju penicilamina, bisfosfonata, ciprofloksacina, entakapona, levodope, levofloksacina, levotiroksina (tiroksina), moksiﬂoksacina, mikofenolata, norfloksacina i ofloksacina.
English: Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand.
Croatian: Feraccru sadrži željezo u stabilnom obliku trovalentnog željeza kao kompleks s trimaltol ligandom.
English: Reported severe adverse reactions were abdominal pain [4%], constipation [0.9%] and diarrhoea [0.9%].
Croatian: Zabilježene teške nuspojave su bol u abdomenu [4 %], zatvor [0,9 %] i proljev
English: Shock can result from hypovolaemia or direct cardiotoxicity.
Croatian: Hipovolemija ili izravna kardiotoksičnost može uzrokovati stanje šoka.
English: • Discomfort or bloating in the stomach
Croatian: • nelagoda ili nadutost u trbuhu
English: Immediate packaging: bottle label
Croatian: Unutarnje pakiranje: naljepnica za bocu
English: Taking too much Feraccru can make the person feel sick or be sick and cause bellyache and diarrhoea.
Croatian: Prekomjerno uzimanje Feraccrua može dovesti do toga da osoba ima mučninu ili povraćanje i može uzrokovati bolove u trbuhu i proljev.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog i vezivnog tkiva
English: As a precautionary measure, it is preferable to avoid the use of Feraccru during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavanje uporabe Feraccrua tijekom trudnoće.
English: Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis.
Croatian: U toj fazi dolazi do pojave hepatocelularne nekroze uz žuticu, krvarenje, hipoglikemiju, encefalopatiju i metaboličku acidozu s pozitivnim anionskim procjepom.
English: Abdominal discomfort/ distension
Croatian: Nelagoda/ distenzija u abdomenu
English: Ferritin continued to rise over long-term treatment with Feraccru (mean 68.9 μg/L [SD 96.24] at 64 weeks, a mean overall improvement of 60.3 μg/L).
Croatian: Feritin se nastavio povećavati tijekom dugoročne terapije Feraccruom (srednja vrijednost 68,9 μg/L [SD 96,24] u 64. tjednu, a srednja vrijednost ukupnog poboljšanja 60,3 μg/L).
English: Total serum iron concentrations and TSAT values were generally higher with increasing Feraccru doses.
Croatian: Ukupne koncentracije željeza u serumu i vrijednosti TSAT-a općenito su bile veće što je bila veća doza Feraccrua.
English: Driving and using machines Feraccru is unlikely to have any effect on the ability to drive and use machines.
Croatian: Nije vjerojatno da Feraccru utječe na sposobnost upravljanja vozilima i strojevima.
English: Following completion of the 12-week placebo-controlled phase of the studies, all subjects were switched to Feraccru 30 mg twice daily open-label treatment for a further 52 weeks.
Croatian: Nakon dovršetka placebom kontrolirane faze ispitivanja u trajanju od 12 tjedana, svi su ispitanici prebačeni na liječenje Feraccruom u dozi od 30 mg dvaput dnevno u dodatnom razdoblju od 52 tjedna u okviru otvorenog ispitivanja.
English: Sunset Yellow (E110) and Allura Red (E129): may cause allergic reactions.
Croatian: Sunset Yellow (E110) i Allura Red (E129): mogu uzrokovati alergijske reakcije.
English: Peak transferrin saturation (TSAT) and total serum iron values were reached 1.5 to 3 hours after oral administration of Feraccru.
Croatian: Vrhunac zasićenja transferina (TSAT) i ukupne vrijednosti željeza u serumu postignuti su od 1,5 do 3 sata nakon peroralne primjene Feraccrua.
English: Absorption of both iron and antibiotic may be reduced if oral iron is given with tetracycline.
Croatian: Apsorpcija i željeza i antibiotika može biti smanjena ako se pripravak željeza za peroralnu primjenu daje zajedno s tetraciklinom.
English: Allura Red AC (E129)
Croatian: Bojilo Allura Red AC (E129)
English: Each capsule contains 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110).
Croatian: Svaka kapsula sadrži 91,5 mg laktoze, 0,5 mg bojila Allura Red AC (E129) i 0,3 mg bojila Sunset
English: Concomitant administration of Feraccru and intravenous iron should be avoided as the combination may induce hypotension or even collapse due to the fast release of iron resulting from saturation of transferrin caused by intravenous iron.
Croatian: Potrebno je izbjegavati istodobnu primjenu Feraccrua i intravenskog željeza jer to može izazvati hipotenziju ili čak nesvjesticu zbog brzog oslobađanja željeza zbog zasićenja transferina uzrokovanog intravenskim željezom.
English: UNCOMMON (≥ 1/1000 to < 1/100)
Croatian: MANJE ČESTO (≥ 1/1000 i < 1/100)
English: No reproductive and developmental toxicity or carcinogenicity studies have been conducted with ferric maltol.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti ili ispitivanja kancerogenosti sa željezovim (III) maltolatom nisu provedena.
English: Concomitant use of iron with dimercaprol should be avoided as the combination of dimercaprol and iron is nephrotoxic.
Croatian: Potrebno je izbjegavati istodobnu uporabu željeza i dimerkaprola jer je kombinacija dimerkaprola i željeza nefrotoksična.
English: No single method of assessment is entirely satisfactory - clinical features as well as laboratory analysis must be taken into account.
Croatian: Potrebno je uzeti u obzir i kliničku sliku kao i laboratorijske pretrage.
English: On the basis of the scientific conclusions for ferric maltol the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ferric maltol is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za željezov (III) maltolat, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) željezov (III) maltolat nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Feraccru has not been studied in patients with impaired renal and/or hepatic function.
Croatian: Feraccru nije ispitivan u bolesnika s oštećenjem funkcije jetre i/ili bubrega.
English: • Colloidal anhydrous silica
Croatian: • Koloidni bezvodni silicijev dioksid
English: An increase of ≥1 g/dL change in Hb at Week 12 was achieved in 90 % and 69 % of the ulcerative colitis (N=29) and Crohn's Disease (N=35) subgroups, respectively.
Croatian: Povećanje od ≥ 1 g/dL promjene u razini Hb-a u 12. tjednu postignuto je kod 90 % bolesnika iz podskupine bolesnika koji boluju od ulceroznog kolitisa (N = 29) i 69 % bolesnika iz podskupine bolesnika koji boluju od Crohnove bolesti (N = 35).
English: Ferric maltol is not systemically available.
Croatian: Željezov (III) maltolat nije sistemski dostupan.
English: The elderly and patients with Heaptic or renal impairment
Croatian: Starije osobe i bolesnici s oštećenjem funkcije jetre ili bubrega
English: Proportion of subjects that achieved normalised Hb at Week
Croatian: Udio ispitanika koji su postigli normalnu razinu Hb-a u 12. tjednu
English: Haemodialysis does not remove iron effectively but should be considered on a supportive basis for acute renal failure as this will facilitate removal of the irondesferroxamine complex.
Croatian: Hemodijalizom se željezo ne može učinkovito ukloniti, no mogućnost primjene hemodijalize treba razmotriti na potpornoj osnovi u slučaju akutnog zatajenja bubrega jer će to olakšati uklanjanje kompleksa željezo-deferoksamin.
English: PHARMACEUTICAL FORM AND CONTENTS 56 capsules METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: OBLIK I SADRŽAJ 56 kapsula NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena kroz usta.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.> 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM < PC: {broj}
English: Mean ferritin (μg/L) levels in subjects taking feraccru improved steadily from baseline (mean 8.6 μg/L [SD 6.77]) to Week 12 (mean 26.0 μg/L [SD 30.57]), a mean overall improvement of 17.4 μg/L.
Croatian: Srednja vrijednost razina feritina (μg/L) u ispitanika koji su uzimali Feraccru postojano se poboljšavala u odnosu na početnu vrijednost (srednja vrijednost 8,6 μg/L [SD 6,77]) do 12. tjedna (srednja vrijednost 26,0 μg/L [SD 30,57]), srednja vrijednost ukupnog poboljšanja 17,4 μg/L.
English: Concomitant use of chloramphenicol with iron should be avoided as chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Croatian: Potrebno je izbjegavati istodobnu uporabu kloramfenikola i željeza jer kloramfenikol odgađa klirens željeza iz plazme i ugradnju željeza u crvene krvne stanice te ometa eritropoezu.
English: Small intestinal bacterial overgrowth
Croatian: Prekomjeran rast bakterija u tankom crijevu Povraćanje
English: However, no carcinogenic effects were recorded in studies conducted in mice and rats receiving up to 400 mg/kg/day maltol.
Croatian: Međutim, u ispitivanjima provedenima na miševima i štakorima koji su primali maltol u dozi do 400 mg/kg/dan nisu zabilježeni kancerogeni učinci.
English: Food has been shown to inhibit uptake of Feraccru: Feraccru should be taken on an empty stomach (see section 4.2)
Croatian: Ustanovljeno je da hrana sprječava apsorpciju Feraccrua: Feraccru treba uzimati natašte (vidjeti dio 4.2).
English: As a precautionary measure, it is preferable to avoid the use of Feraccru during breast-feeding.
Croatian: Kao mjera opreza, preporučuje se izbjegavanje uporabe Feraccrua tijekom dojenja.
English: This medicinal product also contains Allura Red AC (E129) and Sunset Yellow FCF (E110): these may cause allergic reactions.
Croatian: Ovaj lijek također sadrži bojila Allura Red AC (E129) i Sunset Yellow FCF (E110) koja mogu izazvati alergijske reakcije.
English: An increase of ≥2 g/dL change in Hb at Week 12 was achieved in 62 % and 51 % of the ulcerative colitis and Crohn's Disease subgroups, respectively.
Croatian: Povećanje od ≥ 2 g/dL promjene u razini Hb-a u 12. tjednu postignuto je kod 62 % bolesnika iz podskupine bolesnika koji boluju od ulceroznog kolitisa i 51 % bolesnika iz podskupine bolesnika koji boluju od Crohnove bolesti.
English: 83 % of the patients with CD had a CDAI-score <150 and 17 % a CDAI-score >150-220.
Croatian: Crohn's Disease Activity Index), a 17 % CDAI rezultat > 150 - 220.
English: Maximum maltol and maltol glucuronide concentrations were reached approximately 1 hour after oral administration of Feraccru.
Croatian: Najviše koncentracije maltola i maltol glukuronida postignute su otprilike 1 sat nakon peroralne primjene Feraccrua.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP: The expiry date refers to the last day of that month.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „Rok valjanosti“.
English: Blood thyroid stimulating hormone increased Gamma-glutamyltransferase increased
Croatian: Povišena razina alkalne fosfataze u krvi Povišena razina tiroidnog stimulirajućeg hormona u krvi Povišena razina gamaglutamiltransferaze
English: Sunset Yellow FCF (E110)
Croatian: Bojilo Sunset Yellow FCF (E110)
English: • Sunset Yellow FCF (E110) (see section 2)
Croatian: • Bojilo Sunset Yellow FCF (E110) (vidjeti dio 2)
English: Tabulated list of adverse reactions Table 1 presents all adverse reactions occurring during clinical studies to date with Feraccru.
Croatian: U tablici 1. prikazane su sve nuspojave koje su se pojavile tijekom kliničkih ispitivanja lijeka Feraccru do sada.
English: Feraccru contains iron (as ferric maltol).
Croatian: Feraccru sadrži željezo (u obliku željezovog (III) maltolata).
English: • Gelatin
Croatian: • Želatina
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg iron (as ferric maltol).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka kapsula sadrži 30 mg željeza (u obliku željezovog (III) maltolata).
English: 69 % of the patients with UC had a SCCAI score ≤2 and 31 % a SCCAI score of 3.
Croatian: Među bolesnicima s UC-om, njih 69 % imalo je rezultat ≤ 2 prema indeksu SCCAI (engl.
English: You should avoid taking Feraccru if you are experiencing a “flare” of your IBD.
Croatian: Trebate izbjegavati uporabu Feraccrua ako doživljavate razbuktavanje upalne bolesti crijeva.
English: • Allura Red AC (E129) (see section 2)
Croatian: • Bojilo Allura Red AC (E129) (vidjeti dio 2)
English: Maximum maltol and maltol glucuronide concentrations were reached 1 to 1.5 hours after oral administration of Feraccru.
Croatian: Najveće koncentracije maltola i maltol glukuronida postignute su 1 do 1,5 sat nakon peroralne primjene Feraccrua.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Norgine B.V.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Norgine B.V.
English: Feraccru capsules contain lactose, Sunset Yellow FCF (E110) and Allura Red AC (E129).
Croatian: Kapsule Feraccru sadrže laktozu te bojila Sunset Yellow FCF (E110) i Allura Red AC (E129).
English: 4.5 Interaction with other medicinal products and other forms of interaction No drug interaction studies have been performed with Feraccru.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Concomitant use of iron with methyldopa should be avoided as oral iron may antagonise the hypotensive effect of methyldopa.
Croatian: Potrebno je izbjegavati istodobnu uporabu željeza i metildope jer pripravci željeza za peroralnu primjenu mogu umanjiti hipotenzivni učinak metildope.
English: The pharmacokinetic properties of Feraccru was assessed through measurement of plasma and urine concentrations of maltol and maltol glucuronide, together with serum iron parameters after a single dose and at steady state (after 1 week) in 24 subjects with iron deficiency, randomised to receive 30 mg, 60 mg or 90 mg Feraccru twice daily.
Croatian: Farmakokinetička svojstva Feraccrua ocjenjivana su na 24 ispitanika s manjkom željeza randomiziranih za primanje 30 mg, 60 mg ili 90 mg Feraccrua dvaput dnevno, i to putem mjerenja koncentracije maltola i maltol glukuronida u plazmi i urinu uz parametre željeza u serumu nakon jedne doze i u stanju dinamičke ravnoteže (nakon jednog tjedna).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: I DOHVATA DJECE Čuvati izvan pogleda i dohvata djece.
English: NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules Iron (as ferric maltol) STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 30 mg iron (as ferric maltol).
Croatian: NAZIV LIJEKA Feraccru 30 mg tvrde kapsule željezo (u obliku željezovog (III) maltolata) NAVOĐENJE DJELATNE(IH) TVARI Svaka kapsula 30 mg željeza (u obliku željezovog (III) maltolata).
English: How to take Feraccru
Croatian: Kako uzimati Feraccru
English: What Feraccru contains The active substance is 30 mg of iron as ferric maltol.
Croatian: Što sadrži Feraccru Djelatna tvar je 30 mg željeza u obliku željezovog (III) maltolata.
English: Capsule contents: Lactose monohydrate Sodium laurilsulfate Magnesium stearate Colloidal anhydrous silica
Croatian: Natrijev laurilsulfat Magnezijev stearat Koloidni bezvodni silicijev dioksid Krospovidon (vrste A)
English: The PRAC concluded that the product information of products containing ferric maltol should be amended accordingly.
Croatian: PRAC je stoga zaključio da informacije o lijeku lijekova koji sadrže željezov (III) maltolat treba nadopuniti u skladu s navedenim.
English: The median time since last dose of OFP was 22 months in the experimental group and 17 months in the placebo arm. 52 % of the patients in AEGIS 1 and 33 % in AEGIS 2 had a disease flare in the previous 6 months.
Croatian: Razbuktavanje bolesti u prethodnih 6 mjeseci doživjelo je 52 % bolesnika u ispitivanju AEGIS 1 i 33 % u ispitivanju AEGIS 2. Medijan (min - maks) vremena proteklog od posljednjeg razbuktavanja bolesti bio je otprilike 7 mjeseci (0,0 - 450 mjeseci).
English: MARKETING AUTHORISATION HOLDER Norgine B.V.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Norgine B.V.
English: What you need to know before you take Feraccru.
Croatian: Što je Feraccru i za što se koristi Što morate znati prije nego počnete uzimati Feraccru Kako uzimati Feraccru
English: Proportion of subjects that achieved ≥2 g/dL change in Hb at Week
Croatian: Udio ispitanika koji su postigli promjenu u razini Hb-a ≥ 2 g/dL u 12. tjednu (%)
English: Proportion of subjects that achieved ≥1 g/dL change in Hb at Week
Croatian: Udio ispitanika koji su postigli promjenu u razini Hb-a ≥ 1 g/dL u 12. tjednu (%)
English: Call your doctor or hospital straightaway if you or another person has taken too much Feraccru.
Croatian: Ako ste Vi ili neka druga osoba uzeli prekomjernu dozu Feraccrua, smjesta nazovite svog liječnika ili bolnicu.
English: Faeces discolouration was observed in patients treated with ferric maltol in clinical trials.
Croatian: Promjena boje stolice zabilježena je u bolesnika liječenih željezovim (III) maltolatom u kliničkim ispitivanjima.
English: SYSTEM ORGAN CLASS COMMON (≥ 1/100 to < 1/10)
Croatian: ČESTO (≥ 1/100 i < 1/10)
English: Feraccru 30 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Feraccru 30 mg
English: There are no data on the effect of ferric maltol on human fertility.
Croatian: Ne postoje podaci o učincima željezovog (III) maltolata na plodnost u ljudi.
English: Iron deficiency or iron deficiency anaemia (IDA) diagnosis should be made based on blood tests; it is important to investigate the cause of the iron deficiency and to exclude underlying causes of anaemia other than iron deficiency.
Croatian: Na osnovi krvnih pretraga potrebno je utvrditi manjak željeza ili dijagnozu anemije zbog manjka željeza.
English: Haemosiderin was observed in Kupffer cells of dogs administered 250 mg/kg/day maltol.
Croatian: U Kupfferovim stanicama pasa koji su primali 250 mg/kg/dan maltola zapažen je hemosiderin.
English: LIST OF EXCIPIENTS Contains lactose, Sunset Yellow (E110) and Allura Red (E129).
Croatian: POPIS POMOĆNIH TVARI Sadrži laktozu te bojila Sunset Yellow FCF (E110) i Allura Red AC (E129).
English: 1083 HP Amsterdam Netherlands
Croatian: Antonio Vivaldistraat 150 1083 HP Amsterdam Nizozemska
English: How to store Feraccru
Croatian: Kako čuvati Feraccru
English: Feraccru is available in bottles, each containing 56 capsules.
Croatian: Feraccru je dostupan u bocama.
English: Fertility was unaffected following maltol treatment in animal studies.
Croatian: U ispitivanjima na životinjama liječenje maltolom nije utjecalo na plodnost.
English: Do not take Feraccru: - If you are allergic to ferric maltol or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Feraccru: - ako ste alergični na željezov (III) maltolat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6); - ako imate bilo kakvu bolest koja uzrokuje preopterećenje željezom ili ometa način na koji vaše tijelo upotrebljava željezo; - ako ste više puta primili transfuziju krvi.
English: medinfoitaly@norgine.com
Croatian: MedInfo@norgine.com
English: Norgine Italia S.r.l.
Croatian: Norgine Pharmaceuticals Ltd.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: Deposition of iron in the reticulo-endothelial system, liver and spleen was recorded in dogs administered 250 mg/kg/day ferric maltol.
Croatian: U pasa koji su primali 250 mg/kg/dan željezovog a(III) maltolata zabilježeno je taloženje željeza u retikuloendotelnom sustavu, jetri i slezeni.
English: Package leaflet: Information for the patient Feraccru 30 mg hard capsules Iron (as ferric maltol)
Croatian: Feraccru 30 mg tvrde kapsule željezo (u obliku željezovog (III) maltolata)
English: Constipation
Croatian: Doziranje
English: Hb change (g/dL) from Baseline* at Week 8
Croatian: Mjera ishoda Promjena Hb-a (g/dL) u odnosu na početnu vrijednost* u
English: Joint stiffness Pain in extremity
Croatian: Ukočenost zglobova Bol u udovima
English: Gelatin
Croatian: Proljev
English: Ferric maltol
Croatian: Željezov (III) maltolat
English: Marketing Authorisation Holder Norgine B.V.
Croatian: Norgine B.V.
English: Mean(SE)
Croatian: Srednja vrijednost (SE)
English: Discoloured faeces Nausea
Croatian: Ispitivanja upalne bolesti crijeva
English: Norgine Pharmaceuticals Ltd. MedInfo@norgine.com
Croatian: Norgine Italia S.r.l. medinfoitaly@norgine.com
English: The full EPAR for Sialanar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Sialanar nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The starting dose depends on the patient's body weight.
Croatian: Početna doza lijeka ovisi o tjelesnoj težini bolesnika.
English: What is Sialanar and what is it used for?
Croatian: Što je Sialanar i za što se koristi?
English: Sialanar is available as a solution to be taken by mouth three times a day, one hour before or two hours after meals.
Croatian: Lijek Sialanar dostupan je kao otopina koja se uzima kroz usta tri puta dnevno, jedan sat prije ili dva sata poslije obroka.
English: What are the risks associated with Sialanar?
Croatian: Koji su rizici povezani s lijekom Sialanar?
English: What measures are being taken to ensure the safe and effective use of Sialanar?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Sialanar?
English: These receptors trigger the production of saliva when activated by nerves from the brain.
Croatian: Ti receptori potiču stvaranje sline kada ih aktiviraju živci iz mozga.
English: Why is Sialanar approved?
Croatian: Zašto je lijek Sialanar odobren?
English: It must also not be used in patients who are pregnant or are taking potassium chloride tablets or capsules or medicines which have anticholinergic effect.
Croatian: Također se ne smije primjenjivati u trudnica ili bolesnika koji uzimaju tablete koje sadrže kalijev klorid ili kapsule ili lijekove koji imaju antikolinergičko djelovanje.
English: Other information about Sialanar
Croatian: Ostale informacije o lijeku Sialanar
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that benefits of Sialanar outweigh its risks and recommended that it be granted marketing authorisation in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji stoga je zaključilo da koristi od lijeka Sialanar nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet u Europskoj uniji.
English: By blocking the receptors, the medicine is expected to help reduce the amount of saliva produced by the glands and so reduce drooling.
Croatian: Očekuje se da će blokiranjem receptora lijek pomoći u smanjenju sline koju proizvode žlijezde i tako smanjiti slinjenje.
English: This is a summary of the European public assessment report (EPAR) for Sialanar.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Sialanar.