natgillin/translations-raw huggingface dataset:
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.
The adverse reactions occur predominantly at the start of therapy and usually disappear within a few days with continued treatment.
Nuspojave pretežno nastaju na početku terapije i obično nestaju u roku od nekoliko dana s nastavkom liječenja.
The safety profile of Resolor in this 24 week study was consistent with that seen in the previous 12 week studies.
Sigurnosni profil lijeka Resolor u tom 24-tjednom ispitivanju u skladu je s opaženim u prethodnim 12-tjednim ispitivanjima.
Store in the original blister package in order to protect from moisture.
Čuvati u originalnom blister pakiranju radi zaštite od vlage.
At therapeutic doses of Resolor, no effects on breast-fed newborns/infants are anticipated.
Ne očekuje se da će Resolor u terapijskim dozama utjecati na dojeno novorođenče/dojenče.
In an integrated analysis of 17 double-blind placebo-controlled studies, Resolor was given orally to approximately 3,300 patients with chronic constipation.
U integriranoj analizi 17 dvostruko slijepih, placebom kontroliranih ispitivanja, približno 3300 bolesnika s kroničnom konstipacijom peroralno je dobivalo Resolor.
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%)).
Najčešće prijavljene nuspojave povezane s terapijom lijekom Resolor 2 mg jesu glavobolja (17,8%) i gastrointestinalni simptomi (bol u trbuhu (13,7%), mučnina (13,7%) i proljev (12,0%)).
In a small pharmacokinetic study, the Cmax and AUC of prucalopride were, on average, 10-20% higher in patients with moderate to severe hepatic impairment compared with healthy subjects (see sections 4.2 and 4.4).
U malom farmakokinetičkom ispitivanju, Cmax i AUC prukaloprida bili su u prosjeku 10-20% viši u bolesnika s umjerenim do teškim oštećenjem funkcije jetre u usporedbi sa zdravim ispitanicima (vidjeti dijelove 4.2 i 4.4).
The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months.
Djelotvornost prukaloprida ustanovljena je u dvostruko slijepim, placebom kontroliranim ispitivanjima u trajanju do 3 mjeseca.
The following adverse reactions were reported in controlled clinical studies at the recommended dose of 2 mg with frequencies corresponding to very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) and not known (cannot be estimated from available data).
Sljedeće nuspojave zabilježene su u kontroliranim kliničkim ispitivanjima preporučene doze od 2 mg učestalošću koja odgovara sljedećim kategorijama: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
These pharmacodynamic effects of prucalopride have been confirmed in human subjects with chronic constipation using manometry in an open-label, randomised, crossover, reader-blinded study investigating the effect of prucalopride 2 mg and an osmotic laxative on colon motility as determined by the number of colonic high-amplitude propagating contractions (HAPCs, also known as giant migrating contractions).
Navedeni farmakodinamički učinci prukaloprida potvrđeni su u ljudskih ispitanika s kroničnom konstipacijom upotrebom manometrije u otvorenom, randomiziranom, ukriženom ispitivanju sa "zaslijepljenom" osobom koja očitava nalaz, u kojem se ispitivao učinak prukaloprida od 2 mg i osmotskog laksativa na motilitet kolona, određen prema broju propagirajućih kontrakcija kolona velikih amplituda (engl. high-amplitude propagating contractions, HAPC, poznate i pod nazivom opsežne migrirajuće kontrakcije).
Frequencies are calculated based on the integrated analysis of 17 double-blind placebo-controlled clinical studies.
Učestalost se izračunala na temelju integrirane analize 17 dvostruko slijepih, placebom kontroliranih kliničkih ispitivanja.
In all three studies, treatment with Resolor also resulted in significant improvements in a validated and disease specific set of symptom measures (PAC-SYM), including abdominal (bloating, discomfort, pain and cramps), stool (incomplete bowel movements, false alarm, straining, too hard, too small) and rectal symptoms (painful bowel movements, burning, bleeding/tearing), determined at week 4 and week 12.
U sva je tri ispitivanja liječenje lijekom Resolor rezultiralo i značajnim poboljšanjem validiranih mjera niza simptoma specifičnih za bolest (PAC-SYM), uključujući trbušne simptome (nadutost, nelagoda, bol i grčevi), stolicu (nepotpuno pražnjenje crijeva, lažna uzbuna, naprezanje, pretvrda stolica, premala stolica) i rektalne simptome (bolno pražnjenje crijeva, žarenje, krvarenje/razdor), koji su se određivali u 4. i 12. tjednu ispitivanja.
After the first day of treatment, the most common adverse reactions were reported in similar frequencies (incidence no more than 1% different between prucalopride and placebo) during Resolor therapy as during placebo, with the exception of nausea and diarrhoea that still occurred more frequently during Resolor therapy, but less pronounced (differences in incidence between Resolor and placebo of 1.3% and 3.4%, respectively).
Nakon prvog dana liječenja, najčešće nuspojave tijekom terapije lijekom Resolor bile su prijavljene sličnom učestalošću kao i uz placebo (razlika u incidenciji između prukaloprida i placeba nije bila veća od 1%), s izuzetkom mučnine i proljeva koji su i dalje bili češći kod terapije lijekom Resolor, ali manje izraženi (razlike u incidenciji između lijeka Resolor i placeba od 1,3% odnosno 3,4%).
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.
Omjer izloženosti AUC0-24h pri NOAEL-u u usporedbi s djecom (primijenjena je doza od približno 0,04 mg/kg dnevno) kretao se u rasponu od 21 do 71, pružajući odgovarajuće granice sigurnosti za kliničku dozu.
Date of first authorisation: 15 October 2009 Date of latest renewal: 06 June 2014
Datum posljednje obnove odobrenja: 06. lipnja 2014.
Resolor is used for the treatment of chronic constipation in adults in whom laxatives do not work well enough.
Resolor se primjenjuje za liječenje kroničnog zatvora u odraslih u kojih laksativi ne djeluju dovoljno dobro.
Lactose monohydrate Microcrystalline cellulose Colloidal silicon dioxide Magnesium stearate
Jezgra tablete laktoza hidrat mikrokristalična celuloza koloidni silicijev dioksid magnezijev stearat
Aluminium/aluminium perforated unit dose blisters (calendar marked) containing 7 tablets.
Aluminij/aluminij perforirani blisteri djeljivi na jedinične doze (kalendarski označeni) koji sadrže 7 tableta.