FrancophonIA/ELRC3.0 huggingface dataset:
English: Store in the original blister package in order to protect from moisture.
Slovenian: Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred vlago.
English: The efficacy of Resolor was established in three multicentre, randomised, double-blind, 12-week placebo-controlled studies in subjects with chronic constipation (n=1,279 on Resolor, 1,124 females, 155 males).
Slovenian: Učinkovitost zdravila Resolor je bila dokazana v treh multicentričnih randomiziranih, dvojno slepih dvanajsttedenskih s placebom nadzorovanih študijah pri osebah s kroničnim zaprtjem (n = 1.279 na zdravilu Resolor, 1.124 žensk, 155 moških).
English: Table 1: Adverse Drug Reactions (ADRs) Associated with Resolor
Slovenian: Preglednica 1: Neželeni učinki, povezani z zdravilom Resolor
English: There is limited information on the safety and efficacy of Resolor for use in patients with severe and clinically unstable concomitant disease (e.g. cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders).
Slovenian: Podatki o varnosti in učinkovitosti zdravila Resolor za uporabo pri bolnikih s hudimi in klinično nestabilnimi spremljevalnimi boleznimi (tj. srčno-žilnimi boleznimi ali pljučnimi boleznimi, nevrološkimi ali psihiatričnimi motnjami, rakom ali aidsom in drugimi boleznimi endokrinega sistema) so omejeni.
English: Patients with hepatic impairment: Patients with severe hepatic impairment (Child-Pugh class C) start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated (see sections 4.4 and 5.2).
Slovenian: Bolniki z jetrno okvaro: bolniki s hudo jetrno okvaro (Child-Pugh stopnja C) začnejo z odmerkom 1 mg enkrat na dan, nato pa se lahko odmerek poveča na 2 mg, če je to potrebno zaradi učinkovitosti in če bolnik odmerek 1 mg dobro prenaša (glejte poglavji 4.4 in 5.2).
English: Resolor is provided in aluminium/aluminium perforated unit dose blister (calendar marked) containing 7 tablets.
Slovenian: Zdravilo Resolor je na voljo v aluminijastem/aluminijastem perforiranem pretisnem omotu za enkratni odmerek (s koledarskimi označbami), ki vsebuje 7 tablet.
English: Lactose monohydrate (see section 2), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), macrogol.
Slovenian: Pomožne snovi so: laktoza monohidrat (glejte poglavje 2), mikrokristalna celuloza, koloidni silicijev dioksid, magnezijev stearat, hipromeloza, triacetin, titanov dioksid (E171), makrogol.
English: Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Slovenian: Zdravilo Resolor je indicirano za simptomatsko zdravljenje kroničnega zaprtja pri odraslih, ki z odvajali ne dosežejo ustreznega olajšanja.
English: The most frequently reported adverse reactions associated with Resolor 2 mg therapy are headache (17.8%) and gastrointestinal symptoms (abdominal pain (13.7%), nausea (13.7%) and diarrhoea (12.0%)).
Slovenian: Najpogosteje poročani neželeni učinki, povezani z zdravljenjem z zdravilom Resolor v odmerku 2 mg, so glavobol (17,8 %) in prebavni simptomi (bolečine v trebuhu (13,7 %), navzea (13,7 %) ali diareja (12,0 %)).
English: Children weighing >50 kg received 2 mg/day Resolor tablets or matching placebo.
Slovenian: Otroci s telesno maso > 50 kg so dobivali odmerek 2 mg/dan v obliki tablet zdravila Resolor ali ustrezni placebo.
English: Specific treatment is not available for Resolor overdose.
Slovenian: Pri prevelikem odmerjanju zdravila Resolor specifičnega zdravljenja ni.
English: If you forget to take Resolor Do not take a double dose to make up for a forgotten tablet.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
English: The quantitatively most important metabolite in excreta, R107504, accounted for 3.2% and 3.1% of the dose in urine and faeces, respectively.
Slovenian: R107504, ki je najpogostejši presnovek v izločkih, je predstavljal 3,2 % v urinu in 3,1 % v blatu.
English: The efficacy and safety of Resolor in paediatric patients (aged 6 months to 18 years) with functional constipation, were evaluated in an 8-week double-blind, placebo-controlled trial (N=213), followed by a 16 week open-label comparator-controlled (Polyethylene glycol 4000) study of up to 24 weeks (N=197).
Slovenian: Učinkovitost in varnost zdravila Resolor pri pediatričnih bolnikih (starih od 6 mesecev do 18 let) s funkcionalno zaprtostjo so ocenili v 8-tedenskem dvojno slepem, s placebom nadzorovanem preskušanju (n = 213), ki mu je sledila 16-tedenska odprta študija, nadzorovana s primerjalnim zdravilom (polietilenglikol 4000), s trajanjem do 24 tednov (n = 197).
English: Aluminium/aluminium perforated unit dose blisters (calendar marked) containing 7 tablets.
Slovenian: Aluminijast/aluminijast perforiran pretisni omot za enkratni odmerek (s koledarskimi označbami), ki vsebuje 7 tablet.
English: Excipients with known effect: Each film-coated tablet contains 156.75 mg lactose (as monohydrate).
Slovenian: Pomožne snovi z znanim učinkom: ena filmsko obložena tableta vsebuje 156,75 mg laktoze (v obliki monohidrata).
English: Compared to subjects with normal renal function, plasma concentrations of prucalopride after a single 2 mg dose were on average 25% and 51% higher in subjects with mild (ClCR 50-79 ml/min) and moderate (ClCR 25-49 ml/min) renal impairment, respectively.
Slovenian: V primerjavi z osebami z normalno ledvično funkcijo so bile plazemske koncentracije prukolaprida po enkratnem 2 mg odmerku pri osebah z blago (ClCR 50-79 ml/min) in zmerno (ClCR 25-49 ml/min) ledvično okvaro v povprečju 25 % oziroma 51 % višje.
English: Prucalopride did not inhibit specific CYP450 activities in in vitro studies in human liver microsomes at therapeutically relevant concentrations.
Slovenian: Prukaloprid v in vitro študijah mikrosomov človeških jeter pri terapevtsko pomembnih koncentracijah ni zaviral specifičnih dejavnosti CYP450.
English: Resolor is not recommended for use during pregnancy.
Slovenian: Uporaba zdravila Resolor med nosečnostjo se ne priporoča.
English: The results of the study showed no difference in efficacy between Resolor and placebo with response rates of 17% and 17.8% respectively (P=0.9002).
Slovenian: Rezultati študije niso pokazali razlike v učinkovitosti med zdravilom Resolor in placebom - odziv je bil pri zdravilu Resolor 17 % in pri placebu 17,8 % (p = 0,9002).
English: The incidence of subjects with at least 1 treatment-emergent adverse event (TEAE) was similar between the Resolor treatment group (69.8%) and the placebo treatment group (60.7%).
Slovenian: Incidenca preskušancev, pri katerih se je med zdravljenjem pojavil vsaj en neželeni učinek, je bila podobna v skupini z zdravilom Resolor (69,8 %) in v skupini, ki je prejemala placebo (60,7 %).
English: A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2).
Slovenian: Pri osebah s hudo ledvično okvaro se priporoča odmerek 1 mg (glejte poglavje 4.2).
English: - Renal impairment requiring dialysis.
Slovenian: - Ledvične okvare, za katere je potrebna dializa.
English: The starting dose administered was 0.04 mg/kg/day titrated between 0.02 and 0.06 mg/kg/day (to a maximum of 2 mg daily) for children weighing ≤50 kg given as an oral solution of Resolor or matching placebo.
Slovenian: Začetni odmerek pri otrocih s telesno maso ≤ 50 kg je bil 0,04 mg/kg/dan s postopnim povečanjem od 0,02 do 0,06 mg/kg/dan (do največ 2 mg dnevno), apliciran v obliki peroralne raztopine zdravila Resolor ali ustreznega placeba.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in na kartonski ovojnini poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: How to take Resolor
Slovenian: Kako jemati zdravilo Resolor
English: On once daily treatment with 2 mg prucalopride, steady-state plasma concentrations fluctuate between trough and peak values of 2.5 and 7 ng/ml, respectively.
Slovenian: Pri enkratnem dnevnem zdravljenju z 2 mg prukaloprida plazemske koncentracije v stanju dinamičnega ravnovesja nihajo med najnižjimi in najvišjimi vrednostmi 2,5 oziroma 7 ng/ml.
English: In addition, the efficacy, safety and tolerability of Resolor in male patients with chronic constipation were evaluated in a 12-week, multi-centre, randomised, double-blind, placebo-controlled study (N=370).
Slovenian: Poleg tega so učinkovitost, varnost in prenašanje zdravila Resolor pri moških bolnikih s kronično zaprtostjo ovrednotili v 12-tedenski multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani študiji (N = 370).
English: Vomiting, dyspepsia, flatulence, gastrointestinal sounds abnormal
Slovenian: Pogosti bruhanje, dispepsija, flatulenca, nenormalni zvoki v prebavilih
English: The following uncommon side effects have also been seen (may affect up to 1 in 100 people): tremors, pounding heart, rectal bleeding, increase in frequency of passing urine (pollakiuria), fever and feeling unwell.
Slovenian: Opaženi so bili tudi naslednji občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov): tresenje, razbijanje srca, rektalne krvavitve, pogostejše mokrenje (polakiurija), zvišana telesna temperatura in slabo počutje.
English: Effects of prucalopride on pharmacokinetics of other medicinal products A 30% increase in plasma concentrations of erythromycin was found during prucalopride co-administration.
Slovenian: Učinki prukaloprida na farmakokinetiko drugih zdravil Pri sočasnem dajanju prukaloprida so opazili 30-odstotno povečanje koncentracij eritromicina v plazmi.
English: The following side effects have been reported very commonly (may affect more than 1 in 10 people): headache, feeling sick, diarrhoea and abdominal pain.
Slovenian: Zelo pogosto so poročali o naslednjih neželenih učinkih (prizadenejo lahko več kot 1 od 10 bolnikov): glavobol, občutek slabosti, driska in bolečine v trebuhu.
English: The active substance is prucalopride.
Slovenian: Zdravilna učinkovina je prukaloprid.
English: A significant benefit on a number of Quality of Life measures, such as degree of satisfaction with treatment and with bowel habits, physical and psychosocial discomfort and worries and concerns, was also observed at both the 4 and 12 week assessment time points.
Slovenian: V časovnih ocenjevalnih točkah v 4. in v 12. tednu so opažali tudi značilno korist za številna merila kakovosti življenja, denimo za stopnjo zadovoljstva z zdravljenjem in z režimom odvajanja blata, za telesno in psihosocialno neugodje in skrbi ter težave.
English: Response to the treatment was defined as having an average of ≥3 spontaneous bowel movements (SBMs) per week and an average number of faecal incontinence episodes of ≤1 per 2 weeks.
Slovenian: Odziv na zdravljenje je bil opredeljen kot povprečno tri ali več spontanih odvajanj blata tedensko in povprečno največ ena epizoda fekalne inkontinence na dva tedna.
English: Incidence Category
Slovenian: Kategorija pogostosti
English: A clinically meaningful improvement of ≥1 SCBM per week, the most important secondary efficacy endpoint, was achieved in 51.0% (week 4) and 44.2% (week 12) treated with 2 mg Resolor versus 21.7% (week 4) and 22.6% (week 12) of placebo patients.
Slovenian: Klinično pomembno izboljšanje za ≥ 1 SCBM na teden, najpomembnejši sekundarni opazovani dogodek učinkovitosti, je bil dosežen pri 51,0 % (4. teden) in 44,2 % (12. teden) pri zdravljenju z 2 mg zdravila Resolor v primerjavi z 21,7 % (4. teden) in 22,6 % (12. teden) pri bolnikih, zdravljenih s placebom.
English: The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Slovenian: 2 mg tableta vsebuje tudi rdeči železov oksid (E172), rumeni železov oksid (E172), indigotin (E132).
English: The proportion of female patients in whom laxatives fail to provide adequate relief treated with the recommended dose of 2 mg Resolor (n=458) that reached an average of ≥3 SCBM per week was 31.0% (week 4) and 24.7% (week 12), versus 8.6% (week 4) and 9.2% (week 12) on placebo.
Slovenian: Razmerje bolnic, pri katerih laksativ ni privedel do ustreznega olajšanja, zdravljenih s priporočenim odmerkom 2 mg zdravila Resolor (n = 458), ki so dosegle ≥ 3 SCBM na teden, je bil 31,0 % (4. teden) in 24,7 % (12 teden) v primerjavi z 8,6 % (4. teden) in 9,2 % (12. teden) v primerjavi s placebom.
English: Patients with renal impairment: The dose for patients with severe renal impairment (GFR <30 ml/min/1.73 m2) is 1 mg once daily (see sections 4.3 and 5.2).
Slovenian: Bolniki z ledvično okvaro: odmerek za bolnike s hudo ledvično okvaro (GFR < 30 ml/min/1,73 m2) je
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Resolor was generally well tolerated.
Slovenian: Bolniki so v glavnem dobro prenašali zdravilo Resolor.
English: If pounding heart occurs, please tell your doctor.
Slovenian: Če se pojavi razbijanje srca, o tem obvestite zdravnika.
English: The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (i.e., responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the Resolor (25.1%) and placebo (20.7%) treatment groups.
Slovenian: V deležu bolnikov s povprečno tedensko frekvenco treh ali več spontanih popolnih odvajanj blata (SCBM - Spontaneous Complete Bowel Movement) (tj. odzivnih bolnikov) v 24-tedenski dvojno slepi fazi zdravljenja ni bilo statistično značilnih razlik (p = 0,367) med skupinama z zdravilom Resolor (25,1 %) in placebom (20,7 %).
English: At Week 4, the proportion of patients with an improvement of ≥1 versus baseline in the Patient Assessment of Constipation-Quality of Life satisfaction subscale (PAC-QOL) was 47.7% in patients treated with Resolor 2 mg compared with 20.2% in patients on placebo.
Slovenian: V 4. tednu je bilo razmerje bolnikov z izboljšanjem ≥ 1 v primerjavi z izhodiščem na podlestvici vprašalnika bolnikov z zaprtjem o kakovosti življenja (PAC-QOL, Patient Assessment of Constipation-Quality of Life satisfaction subscale) 47,7 % pri bolnikih, zdravljenih z zdravilom Resolor 2 mg, v primerjavi z 20,2 % pri bolnikih, zdravljenih s placebom.
English: The AUC0-24h exposure ratios at the NOAEL versus human children (dosed at approximately 0.04 mg/kg daily) ranged between 21 and 71 providing adequate safety margins for the clinical dose.
Slovenian: V primerjavi s otroki (ki so dobivali dnevne odmerke približno 0,04 mg/kg) so se razmerja izpostavljenosti AUC0-24h pri vrednosti NOAEL gibala med 21 in 71, kar zagotavlja ustrezno varnostno rezervo za klinični odmerek.
English: Excipients with known effect: Each film-coated tablet contains 142.5 mg lactose (as monohydrate).
Slovenian: Pomožne snovi z znanim učinkom: ena filmsko obložena tableta vsebuje 142,5 mg laktoze (v obliki monohidrata).
English: Resolor contains the active substance prucalopride.
Slovenian: Zdravilo Resolor vsebuje zdravilno učinkovino prukaloprid.
English: Furthermore, giant migrating contractions are induced by prucalopride.
Slovenian: Poleg tega prukaloprid sproži velike seleče se kontrakcije.
English: What Resolor contains
Slovenian: Kaj vsebuje zdravilo Resolor
English: The efficacy and safety of Resolor in patients (aged ≥18 or older) with chronic constipation, were evaluated in a 24 week multicentre, randomised, double-blind, placebo controlled study (N=361).
Slovenian: Učinkovitost in varnost zdravila Resolor pri bolnikih (starih ≥18 let) s kronično zaprtostjo so ocenili v 24-tedenski multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani študiji (N = 361).
English: The primary endpoint of the study was met: a statistically significantly higher percentage of subjects in the Resolor group (37.9%) had an average of ≥3 SCBMs/week compared with subjects in the placebo treatment group (17.7%) (p<0.0001) over the 12-week double-blind treatment period.
Slovenian: Primarni cilj študije je bil izpolnjen: v 12-tedenskem dvojno slepem obdobju zdravljenja je imel statistično značilno večji odstotek preizkušancev v skupini Resolor (37,9 %) povprečno ≥ 3 SCBM/teden v primerjavi s preizkušanci v skupini, ki je prejemala placebo (17,7 %) (p < 0,0001).
English: Nausea, diarrhoea, abdominal pain
Slovenian: Zelo pogosti navzea, diareja, bolečine v trebuhu
English: Resolor 2 mg film-coated tablets are pink round shaped tablets marked “PRU 2” on one side.
Slovenian: Filmsko obložene 2 mg tablete Resolor so rožnate okrogle tablete z oznako „PRU 2“ na eni strani.
English: Similar results were observed at Week 12: 46.9% in 2 mg Resolor patients versus 19.0% in placebo patients (p<0.001 vs placebo).
Slovenian: Podobne rezultate so opazili v 12. tednu: 46,9 % pri bolnikih, zdravljenih z zdravilom Resolor 2 mg, v primerjavi z 19,0 % pri bolnikih, zdravljenih s placebom (p < 0,001 v primerjavi s placebom).
English: Resolor contains lactose
Slovenian: Zdravilo Resolor vsebuje laktozo
English: The other ingredients are:
Slovenian: Kaj vsebuje navodilo:
English: - if you are on renal dialysis, - if you suffer from perforation or obstruction of the gut wall, severe inflammation of the intestinal tract, such as Crohn's disease, ulcerative colitis or toxic megacolon/megarectum.
Slovenian: obstruktivni ileus, huda vnetna stanja črevesa, kot so Crohnova bolezen, ulcerativni kolitis in toksični megakolon/megarektum.
English: Always take this medicine exactly as described in this leaflet or as your doctor has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila v tem dokumentu ali navodila svojega zdravnika.
English: It is important to keep to the dose as prescribed by your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Resolor, kot bi smeli Pomembno je, da jemljete odmerek, ki vam ga je predpisal vaš zdravnik.
English: No dose adjustment is required for patients with mild to moderate renal impairment.
Slovenian: Za bolnike z blago do zmerno ledvično okvaro ni potrebna prilagoditev odmerka.
English: Similar results were observed at Week 12: 43.4%, 42.9%, and 31.7% respectively in 2 mg Resolor patients versus 26.9%, 27.2%, and 23.4% in placebo patients (p<0.001 vs placebo).
Slovenian: Podobne rezultate so opazili v 12. tednu: 43,4 %; 42,9 % oz. 31,7 % pri bolnikih, zdravljenih z 2 mg zdravila Resolor, v primerjavi s 26,9 %; 27,2 % oz. 23,4 % pri bolnikih, zdravljenih s placebom (p < 0,001 v primerjavi s placebom).
English: Vertigo
Slovenian: Občasni vertigo
English: The primary efficacy endpoint was the proportion (%) of subjects that reached normalisation of bowel movements defined as an average of three or more spontaneous, complete bowel movements (SCBM) per week over the 12-week treatment period.
Slovenian: Odmerki zdravila Resolor, preučevani v vsaki od teh treh študij, so vključevali 2 mg in 4 mg enkrat na dan. Primarni opazovani dogodek učinkovitosti je bil delež (%) oseb, ki so dosegle normalizacijo odvajanja blata, opredeljen kot povprečje treh ali več spontanih popolnih odvajanj blata (SCBM - spontaneous, complete bowel movements) na teden v 12tedenskem obdobju zdravljenja.
English: The following side effects have been reported commonly (may affect up to 1 in 10 people): decreased appetite, dizziness, vomiting, disturbed digestion (dyspepsia), windiness, abnormal bowel sounds, tiredness.
Slovenian: Pogosto so poročali o naslednjih neželenih učinkih (prizadenejo lahko največ 1 od 10 bolnikov): zmanjšan apetit, vrtoglavica, bruhanje, motena prebava (dispepsija), napenjanje, nenormalni črevesni zvoki, utrujenost.
English: No dose adjustment is required for patients with mild to moderate hepatic impairment.
Slovenian: Za bolnike z blago do zmerno jetrno okvaro prilagoditev odmerka ni potrebna.
English: At week 4, the proportion of patients with an improvement of ≥1 versus baseline in the PAC-SYM abdominal, stool, and rectal symptom subscales was 41.3%, 41.6%, and 31.3% respectively in patients treated with Resolor 2 mg compared with 26.9%, 24.4% and 22.9% in patients on placebo.
Slovenian: V 4. tednu je bilo razmerje bolnikov z izboljšanjem ≥ 1 v primerjavi z izhodiščem na podlestvicah vprašalnika PACSYM pri trebušnih, z odvajanjem blata povezanih in rektalnih simptomih 41,3 %; 41,6% oz. 31,3 % pri bolnikih, zdravljenih z zdravilom Resolor 2 mg, v primerjavi s 26,9 %, 24,4 % in 22,9 % pri bolnikih na placebu.
English: Pink, round, biconvex tablets marked “PRU 2” on one side.
Slovenian: Rožnate okrogle bikonveksne tablete z oznako „PRU 2“ na eni strani.
English: Titanium dioxide (E171) Macrogol
Slovenian: Obloga tablete hipromeloza laktoza monohidrat triacetin titanov dioksid (E171) makrogol
English: System/Organ Class
Slovenian: Organski sistem
English: Resolor 1 mg film-coated tablets Resolor 2 mg film-coated tablets prucalopride
Slovenian: Resolor 1 mg filmsko obložene tablete Resolor 2 mg filmsko obložene tablete prukaloprid
English: Iron oxide red (E172) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
Slovenian: Obloga tablete hipromeloza laktoza monohidrat triacetin titanov dioksid (E171) makrogol rdeči železov oksid (E172) rumeni železov oksid (E172) indigotin (E132)
English: Resolor 1 mg tablets prucalopride
Slovenian: Resolor 1 mg tablete prukaloprid
English: Resolor 2 mg tablets prucalopride
Slovenian: Resolor 2 mg tablete prukaloprid
English: Breast-feeding is not recommended during treatment with Resolor.
Slovenian: Med zdravljenjem z zdravilom Resolor se dojenje odsvetuje.
English: White to off-white, round, biconvex tablets marked “PRU 1” on one side.
Slovenian: Bele do belkaste okrogle bikonveksne tablete z oznako „PRU 1“ na eni strani.
English: Tablet coating Hypromellose Lactose monohydrate Triacetin
Slovenian: Zdravilo Resolor vsebuje laktozo monohidrat.
English: One film-coated tablet of Resolor 1 mg contains 1 mg prucalopride (as succinate).
Slovenian: Ena filmsko obložena tableta zdravila Resolor 1 mg vsebuje 1 mg prukaloprida (v obliki sukcinata).
English: What Resolor looks like and contents of the pack Resolor 1 mg film-coated tablets are white to off-white round shaped tablets marked “PRU 1” on one side.
Slovenian: Filmsko obložene 1 mg tablete Resolor so bele do belkaste okrogle tablete z oznako „PRU 1“ na eni strani.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: One film-coated tablet of Resolor 2 mg contains 2 mg prucalopride (as succinate).
Slovenian: Ena filmsko obložena tableta zdravila Resolor 2 mg vsebuje 2 mg prukaloprida (v obliki sukcinata).
English: Resolor 2 mg film-coated tablets
Slovenian: Resolor 2 mg filmsko obložene tablete
English: Resolor 1 mg film-coated tablets.
Slovenian: Resolor 1 mg filmsko obložene tablete
English: Palpitations
Slovenian: Občasni palpitacije
English: At week 12, 68.3% of patients treated with 2 mg Resolor had an average increase of ≥1 SBM/week versus 37.0% of placebo patients (p<0.001 vs placebo).
Slovenian: povprečno zvišanje ≥1 SBM/teden v primerjavi s 37,0 % bolnikov na placebu (p < 0,001 v primerjavi s placebom).
English: Rectal haemorrhage
Slovenian: Občasni polakiurija
English: Resolor 1 mg film-coated tablets prucalopride
Slovenian: Resolor 1 mg filmsko obložene tablete prukaloprid
English: Resolor 2 mg film-coated tablets prucalopride
Slovenian: Resolor 2 mg filmsko obložene tablete prukaloprid
English: Each film-coated tablet contains 1 mg prucalopride (as succinate)
Slovenian: Ena filmsko obložena tableta vsebuje 1 mg prukaloprida (v obliki sukcinata)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: Izgled zdravila Resolor in vsebina pakiranja