natgillin/translations-raw huggingface dataset:
Non-renal elimination contributes to about 35% of total elimination. 
Nerenalna eliminacija pridonosi približno 35% ukupnoj eliminaciji.
This effect is too small to be clinically relevant. 
Ovaj je učinak preslab da bi bio klinički važan.
Always take this medicine exactly as described in this leaflet or as your doctor has told you. 
Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili onako kako Vam je rekao Vaš liječnik.
What Resolor is and what it is used for 
Što je Resolor i za što se koristi
In case of diarrhoea, make sure that you drink enough water. 
U slučaju proljeva, pazite da pijete dovoljno tekućine.
Overall, the safety profile of Resolor in children was the same as in adults. 
Sveukupno, sigurnosni profil lijeka Resolor u djece bio je isti kao i u odraslih.
- Tell your doctor if you are pregnant or planning to become pregnant. 
- Obavijestite svog liječnika ako ste trudni ili planirate imati dijete.
Resolor with food and drink Resolor can be taken with or without food and drinks, at any time of the day. 
Resolor s hranom i pićem Resolor se može uzimati s hranom i pićem ili bez njih, u bilo koje doba dana.
- Use a reliable method of contraception while you're taking Resolor, to prevent pregnancy. 
- Koristite pouzdanu metodu kontracepcije dok uzimate Resolor, kako biste spriječili trudnoću.
Take Resolor every day for as long as your doctor prescribes it. 
Uzimajte Resolor svaki dan onoliko dugo koliko Vam je to propisao liječnik.
Other adverse reactions have been reported occasionally. 
Povremeno su zabilježene i druge nuspojave.
TQT study 
Ispitivanje TQT
Not for use in children and adolescents younger than 18 years. 
Nije za primjenu u djece i adolescenata mlađih od 18 godina.
The majority of patients continued using prucalopride. 
Većina bolesnika nastavila je uzimati prukaloprid.
Unchanged active substance made up about 92-94% of the total radioactivity in plasma. 
Neizmijenjena djelatna tvar predstavljala je oko 92-94% ukupne radioaktivnosti u plazmi.
Steady-state is reached within three to four days. 
Stanje dinamičke ravnoteže postiže se unutar tri do četiri dana.
What you need to know before you take Resolor 
Što morate znati prije nego počnete uzimati Resolor
Long-term study 
Dugoročno ispitivanje
If you take more Resolor than you should 
Ako uzmete više lijeka Resolor nego što ste trebali
Paediatric population: Resolor should not be used in children and adolescents younger than 18 years (see section 5.1). 
Pedijatrijska populacija: Resolor se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina (vidjeti dio 5.1).
It is important to keep to the dose as prescribed by your doctor. 
Važno je da se pridržavate doze koju Vam je propisao liječnik.
Incidence Category 
Kategorija incidencije
The absolute oral bioavailability is >90%. 
Apsolutna bioraspoloživost je nakon peroralne primjene > 90%.
What Resolor is and what it is used for What you need to know before you take Resolor How to take Resolor 
Što se nalazi u ovoj uputi Što je Resolor i za što se koristi Što morate znati prije nego počnete uzimati Resolor Kako uzimati Resolor
What Resolor contains 
Što Resolor sadrži
If you stop taking Resolor If you stop taking Resolor, your constipation symptoms may come back again. 
Ako prestanete uzimati Resolor Ako prestanete uzimati Resolor, mogu Vam se vratiti simptomi zatvora.
If the intake of once daily prucalopride is not effective after 4 weeks of treatment, the patient should be re-examined and the benefit of continuing treatment reconsidered. 
Ako uzimanje prukaloprida jedanput na dan ne bude djelotvorno nakon 4 tjedna liječenja, bolesnika treba ponovno pregledati i razmotriti korist od nastavka liječenja.
Resolor has been shown not to cause rebound phenomena, nor to induce dependency. 
Pokazalo se da Resolor ne dovodi do povratnog (engl. rebound) fenomena i ne izaziva ovisnost.
Pharmacotherapeutic group: Other drugs for constipation, ATC code: A06AX05. 
Farmakoterapijska skupina: Drugi lijekovi za konstipaciju, ATK oznaka: A06AX05.
The accumulation ratio after once daily dosing ranged from 1.9 to 2.3. 
Omjer nakupljanja nakon primjene jedanput na dan kretao se od 1,9 do 2,3.
If you have taken more Resolor than you should, it is possible that you will get diarrhoea, headache and/or nausea. 
Ako ste uzeli više lijeka Resolor nego što ste trebali, postoji mogućnost da dobijete proljev, glavobolju i/ili mučninu.
See the instructions in the patient leaflet of the contraceptive pill you are taking. 
Pročitajte Uputu o lijeku za kontracepcijske tablete koje uzimate.
In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive). 
U slučaju jakog proljeva, djelotvornost oralnih kontraceptiva može biti smanjena pa se preporučuje uporaba dodatne kontracepcijske metode da se spriječi mogući neuspjeh oralne kontracepcije (vidjeti informacije o propisivanju oralnih kontraceptiva).
This effect can be attributed to a diminished renal function in older people. 
Taj se učinak može pripisati slabijoj funkciji bubrega u starijih osoba.
Ask your doctor for advice before taking any medicine. 
Obratite se svom liječniku za savjet prije nego uzmete neki lijek.
Taking a higher dose than recommended will not make the product work better. 
Uzimanje doze koja je viša od preporučene neće pojačati djelovanje lijeka.
In vitro, human liver metabolism is very slow and only minor amounts of metabolites are found. 
In vitro je metabolizam u ljudskoj jetri vrlo spor i pronalaze se samo male količine metabolita.
R107504, R084536 and R104065 (formed by O-demethylation) were identified as minor plasma metabolites. 
Metaboliti R107504, R084536 i R104065 (koji nastaju O-demetilacijom) ustanovljeni su kao manje prisutni u plazmi.
Resolor is only for adults and should not be taken by children and adolescents up to 18 years. 
Resolor je namijenjen samo odraslima, a djeca i adolescenti u dobi do 18 godina ne smiju ga uzimati.
It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel. 
On djeluje na mišićnu stijenku crijeva i pomaže da se ponovno uspostavi normalno funkcioniranje crijeva.
The majority of adverse events were mild to moderate in intensity. 
Većina nuspojava bile su blagog do umjerenog intenziteta.
The doctor may want to reassess your condition and the benefit of continued treatment after the first 4 weeks and thereafter at regular intervals. 
Liječnik će možda htjeti provjeriti Vaše zdravstveno stanje i korist od nastavka liječenja nakon prva 4 tjedna te u redovitim vremenskim razmacima nakon toga.
Manufacturer Sanico NV Veedijk 59 
Proizvođač Sanico NV Veedijk 59
Resolor is unlikely to affect your ability to drive or use machines. 
Resolor najvjerojatnije neće utjecati na Vašu sposobnost upravljanja vozilima i rada na strojevima.
However, sometimes Resolor may cause dizziness and tiredness, especially on the first day of treatment, and this may have an effect on driving and use of machines. 
Međutim, Resolor može ponekad prouzročiti omaglicu i umor, osobito prvog dana liječenja, i to može utjecati na sposobnost upravljanja vozilima i rada na strojevima.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (including pregnancy, embryonal/foetal development, parturition or postnatal development) (see section 5.3). 
Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke u pogledu reproduktivne toksičnosti (uključujući trudnoću, embrionalni/fetalni razvoj, okot i postnatalni razvoj) (vidjeti dio 5.3).
Other medicines and Resolor Tell your doctor if you are taking, or have recently taken, or might take any other medicines. 
Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
Caution should be exercised when prescribing Resolor to patients with these conditions especially when used in patients with a history of arrhythmias or ischaemic cardiovascular disease. 
Potreban je oprez kad se Resolor propisuje bolesnicima s ovim stanjima, osobito kada se koristi u bolesnika s aritmijama ili ishemijskom kardiovaskularnom bolešću u anamnezi.
These are equivalent to the colonic mass movements in humans, and provide the main propulsive force to defecation. 
One odgovaraju velikim kretnjama debelog crijeva u ljudi i osiguravaju glavnu propulzivnu silu kod defekacije.
Interactions of similar magnitude may be expected with other potent inhibitors of P-gp such as verapamil, cyclosporine A and quinidine. 
Interakcije sličnog opsega mogu se očekivati s drugim jakim inhibitorima P-gp-a kao što su verapamil, ciklosporin A i kinidin.
- If you do become pregnant during treatment with Resolor, tell your doctor. 
- Ako zatrudnite za vrijeme liječenja lijekom Resolor, obavijestite svog liječnika.
Due to the specific mode of action of prucalopride (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy. 
Zbog posebnog načina djelovanja prukaloprida (stimulacija propulzivnih kretnji), ne očekuje se da bi dnevna doza veća od 2 mg povećala djelotvornost.
In the absence of human data in women who actively breast-fed while taking Resolor, a decision should be made whether to discontinue breast-feeding or to discontinue Resolor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Budući da nema podataka u žena koje doje dok uzimaju Resolor, potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje lijekom Resolor uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
Metabolism is not the major route of elimination of prucalopride. 
Metabolizam nije glavni put eliminacije prukaloprida.
Efficacy beyond three months has not been demonstrated in placebo-controlled studies (see Section 5.1). 
Djelotvornost nakon tri mjeseca nije dokazana u placebom kontroliranim ispitivanjima (vidjeti dio 5.1).
If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended. 
Ako imate vrlo jak proljev, kontracepcijske tablete možda neće ispravno djelovati pa se preporučuje dodatna metoda kontracepcije.
How to take Resolor 
Kako uzimati Resolor
This confirmed the results of two placebo controlled QT studies. 
To potvrđuje rezultate dva placebom kontrolirana ispitivanja QT intervala.
Prucalopride has a low pharmacokinetic interaction potential. 
Prukaloprid ima niski potencijal za farmakokinetičke interakcije.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze-galaktoze ne bi trebali uzimati ovaj lijek.
Fertility Animal studies indicate that there is no effect on male or female fertility. 
Plodnost Ispitivanja na životinjama pokazuju da nema utjecaja na plodnost mužjaka i ženki.
Prucalopride is rapidly absorbed; after a single oral dose of 2 mg in healthy subjects, Cmax was attained in 2-3 hours. 
Prukaloprid se brzo apsorbira; nakon jednokratne peroralne primjene doze od 2 mg u zdravih ispitanika, Cmax postignut je u roku od 2-3 sata.
Prucalopride did not inhibit specific CYP450 activities in in vitro studies in human liver microsomes at therapeutically relevant concentrations. 
Prukaloprid nije inhibirao specifičnu aktivnost CYP450 u ispitivanjima in vitro na mikrosomima ljudske jetre pri terapijski važnim koncentracijama.
The clinical significance or benefit of this mechanism of action when compared with other laxatives has not been investigated. 
Nije ispitan klinički značaj ili korist tog mehanizma djelovanja u usporedbi s drugim laksativima.
The plasma clearance of prucalopride averages 317 ml/min. 
Klirens plazme od prukaloprida prosječno iznosi 317 ml/min.
Prucalopride is extensively distributed, and has a steady-state volume of distribution (Vdss) of 567 litres. 
Prukaloprid se opsežno distribuira i ima volumen distribucije u stanju dinamičke ravnoteže (Vdss) od 567 litara.
The usual dose of Resolor for most patients is one 2 mg tablet once a day. 
Uobičajena doza lijeka Resolor za većinu je bolesnika jedna tableta od 2 mg jedanput na dan.
Renal excretion is the main route of elimination of prucalopride (see section 5.2). 
Izlučivanje putem bubrega glavni je put uklanjanja prukaloprida (vidjeti dio 5.2).
Although prucalopride may be a weak substrate for P-glycoprotein (P-gp), it is not an inhibitor of P-gp at clinically relevant concentrations. 
Iako prukaloprid može biti slabi supstrat P-glikoproteina (P-gp), u klinički važnim koncentracijama nije inhibitor P-gp-a.
Resolor is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Resolor se ne preporučuje tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
If you are older than 65 years or have severe liver disease, the starting dose is one 1 mg tablet once a day, which your doctor may increase to 2 mg once a day if needed. 
Ako ste stariji od 65 godina ili imate tešku bolest jetre, početna doza je jedna tableta od 1 mg jedanput na dan koju Vaš liječnik može po potrebi povisiti na 2 mg jedanput na dan.
Therapeutic doses of probenecid, cimetidine, erythromycin and paroxetine did not affect the pharmacokinetics of prucalopride. 
Terapijske doze probenecida, cimetidina, eritromicina i paroksetina nisu utjecale na farmakokinetiku prukaloprida.
A thorough QT study was performed to evaluate the effects of Resolor on the QT interval at therapeutic (2 mg) and supratherapeutic doses (10 mg) and compared with the effects of placebo and a positive control. 
Provedeno je temeljito ispitivanje utjecaja na QT-interval da bi se ocijenili učinci lijeka Resolor na QT interval u terapijskim (2 mg) i supraterapijskim dozama (10 mg) i usporedili s učincima placeba i pozitivne kontrole.
The study is therefore considered to be inconclusive with respect to efficacy. 
Smatra se stoga da u ispitivanju nije konačno ustanovljena djelotvornost.
If you forget to take Resolor Do not take a double dose to make up for a forgotten tablet. 
Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
Resolor is not recommended for use during pregnancy. 
Ne preporučuje se koristiti Resolor tijekom trudnoće.
Cases of spontaneous abortion have been observed during clinical studies, although, in the presence of other risk factors, the relationship to prucalopride is unknown. 
Tijekom kliničkih ispitivanja opaženi su slučajevi spontanih pobačaja, no zbog prisutnosti drugih čimbenika rizika njihova povezanost s prukalopridom nije poznata.
Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. 
U slučaju predoziranja, bolesnika treba liječiti simptomatski i po potrebi uvesti potporne mjere.
A population pharmacokinetic analysis showed that the apparent total clearance of prucalopride was correlated with creatinine clearance, but that age, body weight, sex or race had no influence. 
Analiza populacijske farmakokinetike pokazala je da je prividni ukupni klirens prukaloprida korelirao s klirensom kreatinina, ali da dob, tjelesna težina, spol i rasa nisu imali nikakav utjecaj.
Warnings and precautions Talk to your doctor before taking Resolor. 
Upozorenja i mjere opreza Prije nego što uzmete Resolor, razgovarajte s liječnikom.
Prucalopride is a dihydrobenzofurancarboxamide with gastrointestinal prokinetic activities. 
Prukaloprid je dihidrobenzofurankarboksamid s gastrointestinalnim prokinetičkim djelovanjem.
Of these, over 1,500 patients received Resolor at the recommended dose of 2 mg per day, while approximately 1,360 patients were treated with 4 mg prucalopride daily. 
Među njima je preko 1500 bolesnika primilo Resolor u preporučenoj dozi od 2 mg na dan, dok je oko 1360 bolesnika bilo liječeno dozom od 4 mg prukaloprida na dan.
After once daily dosing of 1 mg, peak plasma concentrations and AUC of prucalopride in older people were 26% to 28% higher than in young adults. 
Nakon primjene doze od 1 mg jedanput na dan, vršne koncentracije u plazmi i AUC prukaloprida u starijih osoba bili su 26% do 28% veći nego u mlađih odraslih osoba.
Effects of other medicinal products on pharmacokinetics of prucalopride Ketoconazole (200 mg twice daily), a potent inhibitor of CYP3A4 and of P-gp, increased the systemic exposure to prucalopride by approximately 40%. 
Učinci drugih lijekova na farmakokinetiku prukaloprida Ketokonazol (200 mg dvaput na dan), jaki inhibitor enzima CYP3A4 i P-gp-a, povisio je sistemsku izloženost prukalopridu za približno 40%.
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. 
Bila je primijećena i značajna korist u mnogim mjerama kvalitete života, kao što su stupanj zadovoljstva liječenjem i crijevnim navikama, tjelesna i psihosocijalna nelagoda te zabrinutost, kako u 4. tjednu tako i u 12. tjednu procjene.
An overdose may result in symptoms resulting from an exaggeration of prucalopride's known pharmacodynamic effects and include headache, nausea and diarrhoea. 
Predoziranje može rezultirati simptomima koji su posljedica pojačanih poznatih farmakodinamičkih učinaka prukaloprida, a uključuju glavobolju, mučninu i proljev.
Other metabolites identified and quantified in urine and faeces were R084536 (formed by N-dealkylation) accounting for 3% of the dose and products of hydroxylation (3% of the dose) and N-oxidation (2% of the dose). 
Drugi metaboliti utvrđeni i kvantificirani u mokraći i stolici bili su R084536 (koji nastaje N-dealkilacijom) odgovoran za 3% doze i produkti hidroksilacije (3% doze) i N-oksidacije (2% doze).
Women of childbearing potential have to use effective contraception during treatment with prucalopride 
Žene reproduktivne dobi moraju primjenjivati djelotvornu kontracepciju za vrijeme liječenja prukalopridom.
In a study in healthy volunteers, treatment with prucalopride was well tolerated when given in an up-titrating scheme up to 20 mg once daily (10 times the recommended therapeutic dose). 
U ispitivanju u zdravih dobrovoljaca, liječenje prukalopridom dobro se podnosilo kad je davan u postupno sve većoj dozi do 20 mg jedanput na dan (doza 10 puta veća od preporučene terapijske doze).
Each pack contains 7 x 1, 14 x 1, 28 x 1 or 84 x 1 film-coated tablet. 
Jedno pakiranje sadrži 7 x 1, 14 x 1, 28 x 1 ili 84 x 1 filmom obloženih tableta.
Renal excretion of unchanged prucalopride involves both passive filtration and active secretion. 
Izlučivanje neizmijenjenog prukaloprida putem bubrega uključuje i pasivnu filtraciju i aktivnu sekreciju.
However, the totality of the data including the other double-blind placebo controlled 12 week studies support the efficacy of Resolor. 
Međutim, ukupni podaci, uključujući ostala dvostruko slijepa, placebom kontrolirana ispitivanja u trajanju od 12 tjedana, podupiru djelotvornost lijeka Resolor.
The pharmacokinetics of prucalopride is dose-proportional within and beyond the therapeutic range (tested up to 20 mg). 
Farmakokinetika prukaloprida razmjerna je dozi unutar i izvan terapijskog raspona (ispitano za doze do 20 mg).
Prucalopride is a selective, high affinity serotonin (5-HT4) receptor agonist, which is likely to explain its prokinetic effects. 
Prukaloprid je selektivni agonist visokog afiniteta prema serotoninskim receptorima (5-HT4), što najvjerojatnije objašnjava njegove prokinetičke učinke.
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). 
Ograničene su informacije o sigurnosti i djelotvornosti Resolora u bolesnika s teškom i klinički nestabilnom popratnom bolešću (npr. kardiovaskularna ili plućna bolest, neurološki ili psihijatrijski poremećaji, rak ili SIDA i drugi endokrini poremećaji).
An updated RMP shall be submitted annually until renewal. 
Dopunjeni Plan upravljanja rizikom podnosi se svake godine do obnove.
Take special care with Resolor and tell your doctor if you: - suffer from severe kidney disease, - suffer from severe liver disease, - are currently under supervision by a doctor for a serious medical problem such as lung or heart disease, nervous system or mental health problems, cancer, AIDS or a hormonal disorder. 
Budite posebno oprezni s lijekom Resolor i obratite se Vašem liječniku ako: - bolujete od teške bolesti bubrega, - bolujete od teške bolesti jetre, - trenutačno ste pod liječničkim nadzorom zbog ozbiljnog zdravstvenog stanja, kao što su bolest pluća ili srca, problemi sa živčanim sustavom ili mentalnim zdravljem, rak, SIDA ili hormonski poremećaj.
In double-blind clinical studies, the incidence of QT-related adverse events and ventricular arrhythmias was low and comparable to placebo. 
U dvostruko slijepim kliničkim ispitivanjima, incidencija nuspojava povezanih s QT intervalom i ventrikularnih aritmija bila je niska i usporediva s onom uz placebo.
The side effects mostly occur at the start of treatment and usually disappear within a few days with continued treatment. 
Nuspojave uglavnom nastaju na početku liječenja i obično nestaju u roku od nekoliko dana s nastavkom liječenja.
Posology Adults: 2 mg once daily with or without food, at any time of day. 
Doziranje Odrasli: 2 mg jedanput na dan, s hranom ili bez nje, u bilo koje doba dana.
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief. 
Resolor je indiciran za simptomatsko liječenje kronične konstipacije u odraslih u kojih se laksativima nije uspjelo postići odgovarajuće olakšanje.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
Unutar svake skupine po učestalosti nuspojave su prikazane redoslijedom prema sve manjoj ozbiljnosti.
The safety profile of Resolor was consistent with that seen in female patients. 
Sigurnosni profil lijeka Resolor bio je konzistentan s onim opaženim u ženskih ispitanika.
Older people (>65 years): Start with 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily. 
Starije osobe (u dobi od > 65 godina): Započeti s 1 mg jedanput na dan (vidjeti dio 5.2); po potrebi se doza može povisiti na 2 mg jedanput na dan.
7 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 84 x 1 film-coated tablets 
7 x 1 filmom obložena tableta 14 x 1 filmom obložena tableta 28 x 1 filmom obložena tableta 84 x 1 filmom obložena tableta
Resolor may have a minor influence on the ability to drive and use machines, since dizziness and fatigue have been observed in clinical studies, particularly during the first day of treatment (see section 4.8). 
Resolor može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima, budući da su u kliničkim ispitivanjima opaženi omaglica i umor, osobito tijekom prvog dana liječenja (vidjeti dio 4.8).
In dogs, the effects observed in the gastrointestinal tract are sensitive to blockade with selective 5-HT4 receptor antagonists illustrating that the observed effects are exerted via selective action on 5-HT4 receptors. 
Opaženi učinci na gastrointestinalni trakt u pasa osjetljivi su na blokadu selektivnim antagonistima receptora 5-HT4, što pokazuje da opaženi učinci nastaju putem selektivnog djelovanja na receptore 5-HT4.
Prucalopride had no clinically relevant effects on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives. 
Prukaloprid nema klinički važnih učinaka na farmakokinetiku varfarina, digoksina, alkohola, paroksetina i oralnih kontraceptiva.