natgillin/translations-raw huggingface dataset:
In dogs, prucalopride alters colonic motility patterns via serotonin 5-HT4 receptor stimulation: it stimulates proximal colonic motility, enhances gastroduodenal motility and accelerates delayed gastric emptying.
Prukaloprid u pasa mijenja obrazac motiliteta kolona putem stimulacije serotoninskih 5-HT4 receptora: stimulira motilitet proksimalnog kolona, pojačava gastroduodenalni motilitet i ubrzava odgođeno pražnjenje želuca.
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.
Primarna mjera ishoda djelotvornosti bio je udio (%) ispitanika koji su postigli normalizaciju pražnjenja crijeva definiranu kao prosječno tri ili više spontanih kompletnih pražnjenja crijeva na tjedan u 12-tjednom razdoblju liječenja.
The quantitatively most important metabolite in excreta, R107504, accounted for 3.2% and 3.1% of the dose in urine and faeces, respectively.
Količinski najvažniji metabolit u ekskretima, R107504, odgovoran je za 3,2% i 3,1% doze u mokraći odnosno u stolici.
The difference between treatment groups in the average weekly frequency of ≥3 SCBMs per week was not statistically significant over Weeks 1-12 which is inconsistent with the 5 other multicentre, randomised, double-blind, 12-week placebo controlled studies demonstrating efficacy at this timepoint in adult patients.
Razlika između ispitivanih skupina u prosječnoj tjednoj učestalosti od tri ili više spontanih kompletnih pražnjenja crijeva na tjedan nije bila statistički značajna u tjednima 1.-12., što nije u skladu s 5 ostalih multicentričnih, randomiziranih, dvostruko slijepih, placebom kontroliranih ispitivanja u trajanju od 12 tjedana koja su dokazala djelotvornost u toj vremenskoj točki u odraslih bolesnika.
In rats, prucalopride in vivo, at doses above 5 mg/kg (at and above 30-70 times the clinical exposure), induced hyperprolactinaemia caused by an antagonistic action at the D2 receptor.
U štakora je prukaloprid, u dozama većima od 5 mg/kg (najmanje 30-70 puta više od kliničke izloženosti), in vivo, izazvao hiperprolaktinemiju prouzročenu antagonističkim djelovanjem na D2 receptore.
Compared with a constipation treatment working through osmotic action, prokinetic stimulation with prucalopride increased colonic motility as measured by the number of HAPCs during the first 12 hours after intake of the investigational product.
U usporedbi s liječenjem konstipacije koje ima osmotsko djelovanje, prokinetička stimulacija prukalopridom povećala je motilitet kolona, što je izmjereno brojem HAPC-a tijekom prvih 12 sati nakon unosa ispitivanog lijeka.
In case of prolonged treatment, the benefit should be reassessed at regular intervals.
U slučaju duljeg liječenja, korist od liječenja treba procjenjivati u redovitim vremenskim razmacima.
Lactose monohydrate (see section 2), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), macrogol.
Laktoza hidrat (pogledajte dio 2), mikrokristalična celuloza, koloidni silicijev dioksid, magnezijev stearat, hipromeloza, triacetin, titanijev dioksid (E171), makrogol.
A human study has shown that prucalopride is excreted in breast milk.
Ispitivanje u ljudi pokazalo je da se prukaloprid izlučuje u majčino mlijeko.
If pounding heart occurs, please tell your doctor.
U slučaju lupanja srca, molimo obratite se svom liječniku.
In an oral dose study with radiolabelled prucalopride in man, small amounts of seven metabolites were recovered in urine and faeces.
U ispitivanju peroralne doze u ljudi pomoću prukaloprida označenog radioizotopom, otkrivene su male količine sedam metabolita u mokraći i stolici.
Resolor is provided in aluminium/aluminium perforated unit dose blister (calendar marked) containing 7 tablets.
Resolor je dostupan u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze (kalendarski označenim) koji sadrže 7 tableta.
In subjects with severe renal impairment (ClCR ≤24 ml/min), plasma concentrations were 2.3 times the levels in healthy subjects (see section 4.2 and 4.4).
U ispitanika s teškim oštećenjem funkcije bubrega (ClCR ≤ 24 ml/min), koncentracije u plazmi bile su 2,3 puta veće od onih u zdravih ispitanika (vidjeti dijelove 4.2 i 4.4).
Specific treatment is not available for Resolor overdose.
Posebno liječenje predoziranja lijekom Resolor nije dostupno.
The Resolor doses studied in each of these three studies included 2 mg and 4 mg once daily.
U svakom od ova tri ispitivanja ispitane su doze lijeka Resolor od 2 mg i 4 mg jedanput na dan.
The active substance is prucalopride.
Djelatna tvar je prukaloprid.
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).
Rezultati ispitivanja nisu pokazali razlike u učinkovitosti između lijeka Resolor i placeba, sa stopama odgovora 17% odnosno 17,8% (P= 0,9002).
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).
Bolesnici s oštećenjem funkcije bubrega: Za bolesnike s teškim oštećenjem funkcije bubrega (GFR < 30 ml/min/1,73 m2) doza je 1 mg jedanput na dan (vidjeti dijelove 4.3 i 5.2).
It is extensively excreted unchanged in urine (approximately 60% of the dose) and in vitro metabolism is very slow.
Opsežno se izlučuje mokraćom u neizmijenjenom obliku (približno 60% doze), a in vitro mu je metabolizam jako spor.
Resolor contains lactose
Resolor sadrži laktozu
Caution should be exercised when prescribing Resolor to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment (see section 4.2).
Bolesnicima s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) treba pristupiti s oprezom kad im se propisuje Resolor, zbog ograničenih podataka u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 4.2).
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%).
Učestalost ispitanika s najmanje 1 nuspojavom izazvanom liječenjem (TEAE) bila je slična kod skupine liječene lijekom Resolor (69,8%) i skupine liječene placebom (60,7%).
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza “Rok valjanosti”.
When breast-feeding, prucalopride can pass into breast milk.
Ako dojite, prukaloprid može prijeći u majčino mlijeko.
Concomitant intake of food does not influence the oral bioavailability of prucalopride.
Istovremeno uzimanje hrane ne utječe na bioraspoloživost prukaloprida primijenjenog peroralno.
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.
U usporedbi s ispitanicima s normalnom funkcijom bubrega, koncentracije prukaloprida u plazmi nakon jednokratne doze od 2 mg bile su u prosjeku 25% veće u ispitanika s blagim oštećenjem funkcije bubrega (ClCR 50-79 ml/min) i 51% veće kod umjerenog oštećenja funkcije bubrega (ClCR 2549 ml/min).
The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Tableta od 2 mg sadrži također crveni željezov oksid (E172), žuti željezov oksid (E172), bojilo indigo karmin aluminium lake (E132).
Palpitations were reported in 0.7% of the placebo patients, 0.9% of the 1 mg prucalopride patients, 0.9% of the 2 mg prucalopride patients and 1.9% of the 4 mg prucalopride patients.
Palpitacije su bile zabilježene u 0,7% bolesnika koji su primali placebo, 0,9% bolesnika koji su uzimali 1 mg prukaloprida, 0,9% bolesnika koji su uzimali 2 mg prukaloprida i 1,9% bolesnika koji su uzimali 4 mg prukaloprida.
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).
Bolesnici s oštećenjem funkcije jetre: Bolesnici s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) počinju s dozom od 1 mg jedanput na dan i ta se doza po potrebi može povisiti na 2 mg kako bi se poboljšala djelotvornost te ako se doza od 1 mg dobro podnosi (vidjeti dijelove 4.4 i 5.2).
The effect of Resolor on spontaneous bowel movements (SBM) also proved to be statistically superior to placebo for the portion of patients that had an increase of ≥1 SBM/week over the 12-week treatment period.
Učinak lijeka Resolor na spontano pražnjenje crijeva također se pokazao statistički superiornim placebu u dijelu bolesnika koji su imali povećanje od ≥1 spontanog pražnjenja crijeva na tjedan u 12-tjednom razdoblju liječenja.
Effects of prucalopride on pharmacokinetics of other medicinal products A 30% increase in plasma concentrations of erythromycin was found during prucalopride co-administration.
Učinci prukaloprida na farmakokinetiku drugih lijekova Koncentracija eritromicina u plazmi bila je povišena za 30% tijekom istovremene primjene prukaloprida.
Table 1: Adverse Drug Reactions (ADRs) Associated with Resolor
Tablica 1: Nuspojave povezane s lijekom Resolor
A large fraction of the active substance is excreted unchanged (60-65% of the administered dose in urine and about 5% in faeces).
Veliki postotak djelatne tvari izluči se u neizmijenjenom obliku (oko 60-65% primijenjene doze u mokraći i približno 5% u stolici).
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).
Djelotvornost lijeka Resolor ustanovljena je u tri multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja u trajanju od 12 tjedana u ispitanika s kroničnom konstipacijom (lijek Resolor je primalo n = 1279; 1124 žena i 155 muškaraca).
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.
Primijenjena početna doza bila je 0,04 mg/kg/dan, titrirana između 0,02 i 0,06 mg/kg/dan (do najviše 2 mg dnevno) za djecu tjelesne težine ≤ 50 kg davana u obliku oralne otopine lijeka Resolor ili odgovarajućeg placeba.
There is a limited amount of data from the use of prucalopride in pregnant women.
Podaci o primjeni prukaloprida u trudnica su ograničeni.
Children weighing >50 kg received 2 mg/day Resolor tablets or matching placebo.
Djeca tjelesne težine > 50 kg primala su 2 mg/dan lijeka Resolor u obliku tableta ili odgovarajućeg placeba.
- Renal impairment requiring dialysis.
- Oštećenje bubrega koje zahtijeva dijalizu.
As with any new symptom, patients should discuss the new onset of palpitations with their physician.
Bolesnici trebaju obavijestiti svog liječnika o novonastalim palpitacijama, kao i o svakom novom simptomu.
The following side effects have been reported very commonly (may affect more than 1 in 10 people): headache, feeling sick, diarrhoea and abdominal pain.
Sljedeće nuspojave zabilježene su vrlo često (mogu se javiti u više od 1 na 10 osoba): glavobolja, mučnina, proljev i bol u trbuhu.
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.
Postignut je primarni ishod ispitivanja: statistički značajno viši postotak ispitanika u skupini liječenoj lijekom Resolor (37,9%) imao je prosječno ≥3 kompletnih pražnjenja crijeva na tjedan, u usporedbi s ispitanicima u skupini koja je liječena placebom (17,7%) (p<0,0001) u 12-tjednom, dvostruko slijepom razdoblju liječenja.
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.
Odgovor na liječenje definiran je kao prosječno ≥ 3 spontanih pražnjenja crijeva na tjedan i prosječno ≤ 1 epizode fekalne inkontinencije u dva tjedna.
The plasma protein binding of prucalopride is about 30%.
Oko 30% prukaloprida veže se za proteine plazme.
Resolor belongs to a group of gut motility enhancing medicines (gastrointestinal prokinetics).
Resolor pripada skupini lijekova koji pojačavaju kretnje probavne cijevi (probavni prokinetici).
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).
Nadalje, djelotvornost, sigurnost i podnošljivost lijeka Resolor u muških bolesnika s kroničnom konstipacijom procijenjene su u 12-tjednom, multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (N=370).
Excipients with known effect: Each film-coated tablet contains 142.5 mg lactose (as monohydrate).
Pomoćne tvari s poznatim učinkom: Jedna filmom obložena tableta sadrži 142,5 mg laktoze (u obliku hidrata).
Via C. Janssen
Via C.
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.
Kod liječenja jedanput na dan dozom od 2 mg, koncentracije prukaloprida u plazmi u stanju dinamičke ravnoteže fluktuiraju između najniže vrijednosti od 2,5 ng/ml i vršne vrijednosti od 7 ng/ml.
An extended series of safety pharmacology studies with special emphasis on cardiovascular parameters showed no relevant changes in haemodynamic and ECG derived parameters (QTc) with the exception of a modest increase in heart rate and blood pressure observed in anaesthetised pigs after intravenous administration, and an increase in blood pressure in conscious dogs after bolus intravenous administration, which was not observed either in anaesthetised dogs or after oral administration in dogs reaching similar plasma levels.
Izuzetak je umjereno povišenje srčane frekvencije i krvnog tlaka opaženo u anesteziranih svinja nakon intravenske primjene i povišenje krvnog tlaka u budnih pasa nakon intravenske bolus injekcije, koje nije bilo opaženo u anesteziranih pasa ili nakon peroralne primjene u pasa u kojih su postignute slične razine u plazmi.
- 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.
- Perforacija ili opstrukcija crijeva zbog strukturnog ili funkcionalnog poremećaja stijenke crijeva, opstruktivnog ileusa, teških upalnih stanja crijeva, kao što su Crohnova bolest i ulcerozni kolitis i toksični megakolon/megarektum.
System/Organ Class
Klasifikacija organskih sustava
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.
Udio žena u kojih laksativi nisu uspjeli osigurati odgovarajuće olakšanje liječenih preporučenom dozom od 2 mg lijeka Resolor (n = 458) koje su postigle prosječno ≥ 3 spontanih kompletnih pražnjenja crijeva na tjedan iznosio je 31,0% (4. tjedan) i 24,7% (12. tjedan), u usporedbi s 8,6% (4. tjedan) i 9,2% (12. tjedan) onih na placebu.
Resolor contains the active substance prucalopride.
Resolor sadrži djelatnu tvar prukaloprid.
No dose adjustment is required for patients with mild to moderate hepatic impairment.
Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
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).
Djelotvornost i sigurnost lijeka Resolor u pedijatrijskim bolesnicima (u dobi od 6 mjeseci do 18 godina) s funkcionalnom konstipacijom procijenjene su u 8-tjednom dvostruko slijepom, placebom kontroliranom ispitivanju (N= 213), nakon čega je uslijedilo otvoreno ispitivanje kontrolirano s usporednim lijekom (polietilen glikol 4000) u trajanju do 24 tjedana (N= 197).
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.
Opažene su i sljedeće manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): nevoljno drhtanje, lupanje srca, krvarenje iz debelog crijeva, učestalo mokrenje (polakizurija), vrućica i loše osjećanje.
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.
Sljedeće nuspojave zabilježene su često (mogu se javiti u do 1 na 10 osoba): smanjen apetit, omaglica, povraćanje, probavne tegobe (dispepsija), vjetrovi, neprirodni probavni zvukovi, umor.
Furthermore, giant migrating contractions are induced by prucalopride.
Nadalje, prukaloprid izaziva opsežne migrirajuće kontrakcije.
Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
Korekcija poremećaja elektrolita može biti potrebna u slučaju opsežnog gubitka tekućine zbog proljeva ili povraćanja.
Excipients with known effect: Each film-coated tablet contains 156.75 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 156,75 mg laktoze (u obliku monohidrata).
How to store Resolor
Kako čuvati Resolor
Titanium dioxide (E171) Macrogol
Ovojnica tablete hipromeloza laktoza hidrat triacetin titanijev dioksid (E171) makrogol
Date of first authorisation:15 October 2009 Date of latest renewal: 06 June 2014
Datum prvog odobrenja:15. listopada 2009.
A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2).
U osoba s teškim oštećenjem funkcije bubrega preporučuje se doza od 1 mg (vidjeti dio 4.2).
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.
Klinički značajno poboljšanje od ≥ 1 spontanog kompletnog pražnjenja crijeva na tjedan, najvažnije sekundarne mjere ishoda djelotvornosti, postiglo je 51,0% (4. tjedan) i 44,2% (12. tjedan) bolesnika liječenih dozom od 2 mg lijeka Resolor u usporedbi s 21,7% (4. tjedan) i 22,6% (12. tjedan) bolesnika na placebu.
Resolor 2 mg film-coated tablets are pink round shaped tablets marked “PRU 2” on one side.
Resolor 2 mg filmom obložene tablete ružičaste su, okrugle tablete s oznakom “PRU 2” na jednoj strani.
Marketing authorisation holder Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
Nositelj odobrenja za stavljanje gotovog lijeka u promet Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza
In vitro, only at concentrations exceeding its 5-HT4 receptor affinity by at least 150-fold, affinity for other receptors was detected.
In vitro je otkriven afinitet za druge receptore, ali samo pri koncentracijama koje su bile 150 puta veće od njegovog afiniteta prema receptorima 5-HT4.
Pink, round, biconvex tablets marked “PRU 2” on one side.
Ružičaste, okrugle, bikonveksne tablete s oznakom “PRU 2” na jednoj strani.
A subcutaneous neonatal/juvenile toxicity study performed in rats 7-55 days of age resulted in a NOAEL of 10 mg/kg/day.
Ispitivanje neonatalne/juvenilne toksičnosti sa supkutanom primjenom na štakorima u dobi od 7 do 55 dana starosti rezultiralo je dozom bez zapaženog štetnog učinka (engl.
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).
Slični rezultati primijećeni su u 12. tjednu: 43,4%, 42,9% odnosno 31,7% u bolesnika na lijeku Resolor 2 mg naspram 26,9%, 27,2% odnosno 23,4% u bolesnika na placebu (p<0,001 naspram placeba).
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.
U 4. tjednu, udio bolesnika s poboljšanjem od ≥1 naspram početne vrijednosti na PAC-SYM podljestvicama trbušnih simptoma, stolice i rektalnih simptoma bio je 41,3%, 41,6% odnosno 31,3% u bolesnika liječenih lijekom Resolor 2 mg u usporedbi s 26,9%, 24,4% odnosno 22,9% u bolesnika na placebu.
White to off-white, round, biconvex tablets marked “PRU 1” on one side.
Bijele do bjelkaste, okrugle, bikonveksne tablete s oznakom “PRU 1” na jednoj strani.
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).
Slični rezultati primijećeni su u 12. tjednu: 46,9% u bolesnika na lijeku Resolor 2 mg naspram 19,0% u bolesnika na placebu (p<0,001 naspram placebo).
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).
Djelotvornost i sigurnost lijeka Resolor u bolesnika (u dobi od ≥18 godina) s kroničnom konstipacijom procijenjene su u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedana (N=361).
This study did not show significant differences between Resolor and placebo at either dose, based on mean QT measurements and outlier analysis.
U ovom se ispitivanju, na temelju prosjeka izmjerenih QT vrijednosti i analize netipičnih vrijednosti (engl. outliers), nisu pokazale značajne razlike između lijeka Resolor i placeba ni kod jedne doze.
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.
- Podljestvica zadovoljstva kvalitetom života (PACQOL) bio je 47,7% u bolesnika liječenih lijekom Resolor 2 mg u usporedbi s 20,2% u bolesnika na placebu.
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).
U 12. tjednu, 68,3% bolesnika liječenih s 2 mg lijeka Resolor imalo je prosječno povećanje od ≥1spontanog pražnjenja crijeva na tjedan u usporedbi s 37,0% bolesnika na placebu (p<0,001 naspram placeba).
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 prucalopride (25.1%) and placebo (20.7%) treatment groups.
Udio ispitanika s prosječnom tjednom učestalosti od tri ili više spontanih kompletnih pražnjenja crijeva na tjedan (tj. ispitanici koji su odgovorili na terapiju) u 24-tjednoj, dvostruko slijepoj fazi liječenja nije se statistički razlikovao (p=0,367) u skupini ispitanika liječenoj prukalopridom (25,1%) u usporedbi sa skupinom ispitanika koji su primali placebo (20,7%).
Iron oxide red (E172) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
Ovojnica tablete hipromeloza laktoza hidrat triacetin titanijev dioksid (E171) makrogol željezov oksid, crveni (E172) željezov oksid, žuti (E172) bojilo indigo karmin aluminum lake (E132)
Breast-feeding is not recommended during treatment with Resolor.
Za vrijeme liječenja lijekom Resolor, dojenje se ne preporučuje.