FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies V9222 and V9236, OIC was confirmed through a 2-week run-in period and was defined as ≤5 SBMs during the 14 consecutive days prior to the randomisation and ≥1 of the following bowel symptoms in ≥25% of all BMs regardless of the use of rescue laxatives: presence of straining during bowel movement, feeling of incomplete evacuation, passage of hard stools or small pellets.
Croatian: U ispitivanjima V9222 i V9236, konstipacija uzrokovana opioidima bila je potvrđena tijekom dvotjednog uvodnog razdoblja i definirana kao ≤5 spontanih pražnjenja crijeva tijekom 14 uzastopnih dana prije randomizacije i ≥1 od sljedećih crijevnih simptoma u ≥25% svih pražnjenja crijeva bez obzira na primjenu laksativa za hitno olakšanje tegoba: prisutnost naprezanja tijekom pražnjenja crijeva, osjećaj nepotpuno ispražnjenih crijeva, tvrda stolica ili stolica u obliku kuglica.
English: The effect of hepatic impairment on the pharmacokinetics of a single 200 microgram dose of naldemedine was studied in subjects with hepatic impairment classified as mild (Child-Pugh class A) or moderate (Child-Pugh class B) and compared with healthy subjects with normal hepatic function.
Croatian: Učinak oštećenja funkcije jetre na farmakokinetiku jedne doze naldemedina od 200 mikrograma ispitan je u ispitanika s oštećenjem funkcije jetre kategoriziranim kao blago (Child-Pugh stadij A) ili umjereno oštećenje (Child-Pugh stadij B) i uspoređen sa zdravim ispitanicima s normalnom funkcijom jetre.
English: Concomitant use of strong CYP3A inhibitors such as grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu jakih inhibitora CYP3A poput soka od grejpa, itrakonazola, ketokonazola, ritonavira, indinavira, sakvinavira, telitromicina i klaritromicina.
English: Rizmoic 200 micrograms film-coated tablets
Croatian: Rizmoic 200 mikrograma filmom obložene tablete
English: Dose-dependent increases in gastrointestinal-related adverse reactions, including abdominal pain, diarrhoea, and nausea, were observed.
Croatian: Opaženo je povećanje nuspojava povezanih s probavnim sustavom ovisno o dozi, uključujući bol u abdomenu, proljev i mučninu.
English: No adverse effects were observed in male or female fertility and reproductive performance at up to 1000 mg/kg/day (in excess of 16,000 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms).
Croatian: Nisu bili opaženi štetni učinci na plodnost mužjaka i ženki te njihovu reproduktivnu sposobnost pri dozama do 1000 mg/kg na dan (više od 16 000 puta veća izloženost [AUC0-24hr] od one u ljudi kod primjene peroralne doze od 200 mikrograma).
English: Concomitant use of naldemedine with strong CYP3A inducers (e.g. St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin) leads to a decrease in naldemedine exposure and may reduce the efficacy of naldemedine.
Croatian: Istodobna primjena naldemedina s jakim induktorima CYP3A (npr. gospinom travom (Hypericum perforatum), rifampicinom, karbamazepinom, fenobarbitalom i fenitoinom) dovodi do smanjene izloženosti naldemedinu i može smanjiti djelotvornost naldemedina.
English: Patients receiving a stable opioid morphine equivalent daily dose of ≥ 30 mg for at least 4 weeks before enrollment and self-reported OIC were eligible to participate.
Croatian: Pogodnima za sudjelovanje smatrali su se bolesnici koji su prije uključenja primali stabilnu dnevnu dozu od ≥30 mg opioida ekvivalentnog morfiju tijekom najmanje 4 tjedna i izjavili su da imaju konstipaciju uzrokovanu opioidima.
English: The overall benefit-risk of naldemedine should be considered in these patients with close monitoring for symptoms of opioid withdrawal.
Croatian: U ovih se bolesnika mora razmotriti cjelokupni omjer koristi i rizika naldemedina uz pažljivo praćenje simptoma ustezanja od opioida.
English: Opioid withdrawal syndrome aOne serious report of hypersensitivity reaction was observed in clinical studies with naldemedine.
Croatian: Opći poremećaji i reakcije na mjestu primjene sindrom ustezanja od opioida aJedan slučaj ozbiljne preosjetljivosti povezane s liječenjem zabilježen je u kliničkim ispitivanjima naldemedina.
English: Concomitant use with strong CYP3A inhibitors and inducers Concomitant use of naldemedine with strong CYP3A inhibitors (e.g. grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin) leads to an increase in naldemedine exposure and may increase the risk of adverse reactions.
Croatian: Istodobna primjena s jakim inhibitorima i induktorima CYP3A Istodobna primjena naldemedina s jakim inhibitorima CYP3A (npr. sokom od grejpa, itrakonazolom, ketokonazolom, ritonavirom, indinavirom, sakvinavirom, telitromicinom i klaritromicinom) dovodi do povećane izloženosti naldemedinu i može povećati rizik od nuspojava.
English: How to store Rizmoic
Croatian: Kako čuvati Rizmoic
English: Very Common Common
Croatian: Vrlo često
English: In Study V9235, the three most common types of pain were back pain (58.0%); osteoarthritis (9.5%) and neck pain (8.1%).
Croatian: U ispitivanju V9235, tri najčešće vrste bola bile su bol u leđima (58,0%); osteoartritis (9,5%) i bol u vratu (8,1%).
English: CI=Confidence Interval *Statistically significant: p-values based on the Cochran-Mantel-Haenszel test. ** p<0.0001 *** p=0.0003 for study V9231 and p=0.0011 for study V9232
Croatian: ** p<0,0001 ***p=0,0003 za ispitivanje V9231 i p=0,0011 za ispitivanje V9232.
English: In the rat fertility and early embryonic development study, prolongation of the dioestrous phase was observed at 10 mg/kg/day and above, but was not observed at 1 mg/kg/day (12 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms).
Croatian: U ispitivanju utjecaja na plodnost i rani embrionalni razvoj u štakora bilo je opaženo produljenje faze diestrusa pri dozi od 10 mg/kg na dan i višoj, ali to nije bilo opaženo pri dozi od 1 mg/kg na dan (12 puta veća izloženost [AUC0-24hr] od one u ljudi kod primjene peroralne doze od 200 mikrograma).
English: The safety and efficacy of naldemedine was also evaluated in 2 randomised, double-blind and placebocontrolled studies (V9222 and V9236) in patients with cancer and OIC.
Croatian: Klinička ispitivanja u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima Sigurnost i djelotvornost naldemedina također je bila procijenjena u 2 randomizirana, dvostruko slijepa i placebom kontrolirana ispitivanja (V9222 i V9236) u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima.
English: Talk to your doctor or pharmacist if you are taking any of the following medicines: - Rifampicin, clarithromycin or telithromycin (antibiotic medicines) - Itraconazole or ketoconazole (medicines to treat fungal infections) - Ritonavir, indinavir or saquinavir (medicines for HIV infection) - Phenytoin, carbamazepine, phenobarbital (medicines to treat epilepsy) - St John's wort (Hypericum perforatum), a herbal medicine used for depression
Croatian: - itrakonazol ili ketokonazol (lijekovi za liječenje gljivičnih infekcija) - ritonavir, indinavir ili sakvinavir (lijekovi za liječenje HIV-infekcije) - fenitoin, karbamazepin, fenobarbital (lijekovi za liječenje epilepsije) - gospina trava (Hypericum perforatum), biljni lijek koji se primjenjuje kod depresije.
English: In Study V9231, the three most common types of pain were back pain (62.0%); neck pain (8.3%) and osteoarthritis (5.3%).
Croatian: U ispitivanju V9231, tri najčešće vrste bola bile su bol u leđima (62,0%); bol u vratu (8,3%) i osteoartritis (5,3%).
English: Stopping Rizmoic while continuing to take your opioid medicine may cause the constipation to return.
Croatian: Ako prestanete uzimati Rizmoic dok i dalje uzimate opioidni analgetik, možete ponovno dobiti zatvor.
English: If naldemedine is used with strong P-gp inhibitors, monitor for adverse reactions.
Croatian: Ako se naldemedin primjenuje s jakim inhibitorima P-gp-a, pratite bolesnika zbog mogućih nuspojava.
English: The efficacy and safety of naldemedine has been established in patients with chronic non-cancer pain and OIC and in patients with cancer and OIC.
Croatian: Djelotvornost i sigurnost naldemedina ustanovljene su u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima te u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima.
English: • fever
Croatian: • vrućicu
English: Concomitant use with strong CYP3A inhibitors should be avoided.
Croatian: Istodobnu primjenu s jakim inhibitorima CYP3A treba izbjegavati.
English: The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved without discontinuation of naldemedine treatment.
Croatian: Ove gastrointestinalne nuspojave bile su većinom blage do umjereno teške i povukle su se bez prekida primjene naldemedina.
English: You should stop taking Rizmoic when you stop taking your opioid pain medicine.
Croatian: Ako prestanete uzimati opioidni analgetik Trebate prestati uzimati Rizmoic kad prestanete uzimati opioidni analgetik.
English: Concomitant use of strong CYP3A inducers such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin is not recommended.
Croatian: Ne preporučuje se istodobna primjena jakih induktora CYP3A poput gospine trave (Hypericum perforatum), rifampicina, karbamazepina, fenobarbitala i fenitoina.
English: • nausea (feeling sick) or vomiting
Croatian: • mučninu ili povraćanje
English: • If you experience a serious allergic reaction, stop taking Rizmoic and see a doctor or go to a hospital straight away.. Serious allergic reactions include: swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash.
Croatian: Ozbiljna alergijska reakcija uključuje: oticanje šaka, stopala, gležnjeva, lica, usana ili grla, što može otežati gutanje ili disanje, svrbež kože i koprivnjača.
English: All study participants took laxatives previously for the treatment of OIC.
Croatian: Svi bolesnici u ispitivanju prethodno su uzimali laksative za liječenje konstipacije uzrokovane opioidima.
English: The pharmacokinetics of naldemedine after administration of a single 200 microgram dose of naldemedine was studied in subjects with mild, moderate or severe renal impairment, or with endstage renal disease (ESRD) requiring haemodialysis, and compared with healthy subjects with normal renal function.
Croatian: Farmakokinetika naldemedina nakon primjene jedne doze od 200 mikrograma naldemedina ispitana je u ispitanika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega ili završnim stadijem bolesti bubrega (engl. end-stage renal disease, ESRD) koja zahtijeva hemodijalizu te uspoređena s onom u zdravih ispitanika s normalnom funkcijom bubrega.
English: Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete manitol karmelozanatrij, umrežena magnezijev stearat
English: If use with strong CYP3A inhibitors is unavoidable, monitor for adverse reactions (see section 4.4).
Croatian: Ako se primjena s jakim inhibitorima CYP3A ne može izbjeći, pratite bolesnika zbog mogućih nuspojava (vidjeti dio 4.4).
English: • a stomach ulcer;
Croatian: • vrijed želuca
English: Naldemedine also undergoes cleavage in the gastrointestinal tract to form benzamidine and naldemedine carboxylic acid.
Croatian: Naldemedin se i cijepa u gastrointestinalnom traktu, čime nastaju benzenkarboksamid i naldemedinkarboksamid.
English: • Periodic safety update reports
Croatian: Periodička izvješća o neškodljivosti
English: No dose adjustment is required in patients with renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Opioid withdrawal syndrome aMedDRA Preferred Terms: abdominal pain, abdominal pain upper, abdominal pain lower and abdominal discomfort
Croatian: Opći poremećaji i reakcije na mjestu primjene sindrom ustezanja od opioida aMedDRA preporučeni pojmovi: bol u abdomenu, bol u gornjem dijelu abdomena, bol u donjem dijelu abdomena i nelagoda u abdomenu
English: Placental transfer of [carbonyl-14C]-naldemedine-derived radioactivity was observed in pregnant rats.
Croatian: U skotnih ženki štakora opažen je placentalni prijenos radioaktivnosti s porijeklom iz [karbonil-14C]naldemedina.
English: A single dose of naldemedine up to 100 mg and multiple doses of up to 30 mg/day for 10 days were administered to healthy volunteers in clinical studies.
Croatian: Zdravim dobrovoljcima u kliničkim ispitivanjima davana je jedna doza naldemedina do 100 mg i višestruke doze do 30 mg na dan tijekom 10 dana.
English: Proportion of SBM responders in patients with cancer and OIC during the 2-week treatment period (Studies V9222 and V9236)
Croatian: Tablica 5. Udio bolesnika s terapijskim odgovorom u vidu spontanog pražnjenja crijeva među bolesnicima s karcinomom i konstipacijom uzrokovanom opioidima tijekom dvotjednog razdoblja liječenja (ispitivanja V9222 i V9236)
English: • cancer of the bowel or peritoneum.
Croatian: • karcinom debelog crijeva ili peritoneuma (to je sluznica koja prekriva crijeva)
English: Manufacturing Packaging Farmaca (MPF) B.V., Appelhof 13,
Croatian: Manufacturing Packaging Farmaca (MPF) B.V.
English: A single dose of naldemedine (0.01 mg to 3 mg) and multiple doses of 0.4 mg/day have been administered to patients with OIC in clinical studies.
Croatian: U kliničkim ispitivanjima bolesnicima s konstipacijom uzrokovanom opioidima bila je primijenjena jedna doza naldemedina (0,01 mg do 3 mg) i višestruke doze od 0,4 mg na dan.
English: There were 4 secondary endpoints in Studies V9231 and V9232 (see Table 3).
Croatian: U ispitivanjima V9231 i V9232 koristile su se 4 sekundarne mjere ishoda (vidjeti tablicu 3).
English: Adverse reactions presented by System Organ Class and frequency in patients with chronic non-cancer pain and opioid-induced constipation
Croatian: Nuspojave prikazane prema klasifikaciji organskih sustava i učestalosti u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima
English: Package leaflet: Information for the patient Rizmoic 200 micrograms film-coated tablets naldemedine This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Rizmoic 200 mikrograma filmom obložene tablete naldemedin
English: The mean baseline SBMs was 1.31, 1.17, and 1.60, for Studies V9231, V9232 and V9235 respectively.
Croatian: Početna srednja vrijednost broja spontanih pražnjenja crijeva bila je 1,31 u ispitivanju V9231, 1,17 u ispitivanju V9232 i 1,60 u ispitivanju V9235.
English: • hairs of the skin standing on end
Croatian: • naježenost kože
English: The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved with treatment.
Croatian: Ove gastrointestinalne nuspojave bile su većinom blage do umjerene težine i povukle su se s liječenjem.
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivosta
English: Change in the frequency of BMs per week from baseline to each visit (LS Mean) ITT population in study V9235
Croatian: Tablica 4. Promjena u učestalosti pražnjenja crijeva tjedno od početka do svakog kontrolnog pregleda populacije predviđene za liječenje u ispitivanju V9235 (srednja vrijednost dobivena metodom najmanjih kvadrata)
English: The pharmacokinetics of naldemedine between subjects with mild or moderate hepatic impairment and healthy subjects with normal hepatic function were similar.
Croatian: Farmakokinetika naldemedina u ispitanika s blagim ili umjerenim oštećenjem funkcije jetre bila je slična onoj u zdravih ispitanika s normalnom funkcijom jetre.
English: The pharmacokinetics of naldemedine between subjects with mild, moderate or severe renal impairment, or subjects with ESRD requiring hemodialysis and healthy subjects with normal renal function were similar.
Croatian: Farmakokinetika naldemedina u ispitanika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega ili ispitanika s ESRD-om na hemodijalizi bila je slična onoj u zdravih ispitanika s normalnom funkcijom bubrega.
English: Heerenveen,
Croatian: Učinci drugih lijekova na naldemedin
English: Naldemedine must not be used in patients with known or suspected GI obstruction or in patients at increased risk of recurrent obstruction, due to the potential for GI perforation (see section 4.3).
Croatian: Naldemedin se ne smije primjenjivati u bolesnika za koje se zna ili sumnja na to da imaju gastrointestinalnu opstrukciju ili u bolesnika s povećanim rizikom od rekurentne opstrukcije, zbog mogućnosti nastanka gastrointestinalne perforacije (vidjeti dio 4.3).
English: Naldemedine 200 micrograms or placebo was administered for 2 weeks to cancer patients with OIC.
Croatian: Bolesnici s karcinomom i konstipacijom uzrokovanom opioidima primali su naldemedin u dozi od 200 mikrograma ili placebo 2 tjedna.
English: Naldemedine should not be used during breast-feeding.
Croatian: Naldemedin se ne smije primjenjivati tijekom dojenja.
English: • vomiting
Croatian: • povraćanje
English: Adverse reactions presented by System Organ Class and frequency in patients with cancer and opioid-induced constipation
Croatian: Tablica 2. Nuspojave prikazane prema klasifikaciji organskih sustava i učestalosti u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima
English: Naldemedine (N=58)
Croatian: (N=58)
English: Abdominal adverse reactions (e.g. abdominal pain, vomiting and diarrhoea) have been reported with Rizmoic.
Croatian: Uz primjenu lijeka Rizmoic prijavljene su abdominalne nuspojave (npr. bol u abdomenu, povraćanje i proljev).
English: Change in frequency of SBMs without straining per week (LS Mean)
Croatian: Promjena učestalosti spontanog pražnjenja crijeva bez naprezanja tjedno (srednja vrijednost dobivena metodom najmanjih kvadrata)
English: (1 to 1.3-fold) for peak plasma concentration and area under the plasma concentration-time curve was observed after once daily multiple dose administration in the fasted state for 10 days.
Croatian: Nakon primjene višestruke doze jedanput dnevno natašte tijekom 10 dana opaženo je blago nakupljanje (1 do 1,3 puta) za vršnu koncentraciju u plazmi i površinu ispod krivulje plazmatska koncentracija-vrijeme.
English: Rizmoic contains the active substance naldemedine.
Croatian: Rizmoic sadrži djelatnu tvar naldemedin.
English: Rizmoic
Croatian: • proljev
English: Each film-coated tablet contains 200 micrograms naldemedine (as tosylate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 200 mikrograma naldemedina (u obliku naldemedintosilata).
English: The mean baseline opioid morphine equivalent daily dosage was 132.42 mg, 120.93 mg, and 122.06 mg per day for Studies V9231, V9232 and V9235 respectively.
Croatian: U ispitivanjima V9231, V9232 odnosno V9235, srednja vrijednost početne dnevne doze opioida ekvivalentnog morfiju iznosila je 132,42 mg, 120,93 mg odnosno 122,06 mg na dan.
English: The patient recovered following discontinuation from the study bMedDRA Preferred Terms: abdominal pain, abdominal pain upper, abdominal pain lower and abdominal discomfort
Croatian: bMedDRA preporučeni pojmovi: bol u abdomenu, bol u gornjem dijelu abdomena, bol u donjem dijelu abdomena i nelagoda u abdomenu
English: Naldemedine (N=621)
Croatian: (N=621)
English: There was a statistically significant difference for naldemedine treatment group versus placebo for the primary endpoint in Studies V9231 and V9232 (see Table 3).
Croatian: U ispitivanjima V9231 i V9232, postojala je statistički značajna razlika u primarnoj mjeri ishoda između skupine liječene naldemedinom i skupine koja je primala placebo (vidjeti tablicu 3).
English: One serious case of abdominal pain and one serious case of nausea were reported in patients with chronic non-cancer pain and OIC.
Croatian: U bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima zabilježen je jedan ozbiljan slučaj bola u abdomenu i jedan ozbiljan slučaj mučnine.
English: • pupils dilating
Croatian: • proširene zjenice
English: Opioid pain medicinal products
Croatian: Opioidni analgetici
English: Diarrhoea Abdominal painb Nausea
Croatian: Poremećaji probavnog sustava proljev bol u abdomenua gastrointestinalna perforacija
English: Vomiting
Croatian: Doziranje
English: Naldemedine must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
Croatian: Zbog mogućnosti nastanka gastrointestinalne perforacije, naldemedin se ne smije primjenjivati u bolesnika u kojih se zna ili sumnja na to da imaju gastrointestinalnu opstrukciju ili u bolesnika pod povećanim rizikom od rekurentne opstrukcije.
English: Each tablet contains 200 micrograms naldemedine (as tosylate).
Croatian: Što Rizmoic sadrži - Jedna tableta sadrži 200 mikrograma naldemedina (u obliku tosilata).
English: Two serious cases of diarrhoea were reported in patients with cancer and OIC.
Croatian: U bolesnika s karcinomom i konstipacijom uzrokovanom opioidima zabilježena su dva ozbiljna slučaja proljeva.
English: • diarrhoea
Croatian: • zijevanje
English: Naldemedine (N=97)
Croatian: (N=97)
English: Mannitol
Croatian: • mučnina
English: Change in frequency of CSBMs per week (LS Mean)
Croatian: Promjena učestalosti spontanog pražnjenja crijeva tjedno (srednja vrijednost dobivena metodom najmanjih kvadrata)
English: These were mild or moderate in severity and resolved.
Croatian: Te su nuspojave bile blage do umjerene težine i povukle su se.
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Rizmoic
English: Hepatic impairment
Croatian: • bolne mišiće
English: Talk to your doctor if you stop taking Rizmoic.
Croatian: Ako prestanete uzimati Rizmoic, obratite se liječniku.
English: Clinical studies in patients with cancer and OIC
Croatian: Klinička ispitivanja u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima
English: Naldemedine (N=276)
Croatian: (N=276)
English: Breast-feeding
Croatian: Heerenveen
English: Tablet core
Croatian: Oštećenje funkcije bubrega
English: Severe hepatic impairment
Croatian: Teško oštećenje funkcije jetre
English: Posology
Croatian: OBLIK
English: Do not worry.
Croatian: Ne brinite.
English: * if needed
Croatian: * ako je potrebno
English: Check with your doctor if you are not sure.
Croatian: Provjerite sa liječnikom ako niste sigurni.
English: These measures will help protect the environment.
Croatian: Ove mjere će pomoći u zaštiti okoliša.
English: Take care if you are taking the following medicines:
Croatian: Budite oprezni ako uzimate sljedeće lijekove:
English: Date of first authorisation: 18 December 2008
Croatian: Datum prvog odobrenja: 18. prosinca 2008.
English: In this case, you will have to take the tablets only once or twice a day.
Croatian: U ovom slučaju uzimat ćete tablete samo jedanput ili dvaput dnevno.
English: Do not try to make up for the missed dose.
Croatian: Ne pokušavajte nadoknaditi propuštenu dozu.
English: You should tell your doctor if this occurs.
Croatian: Obavijestite liječnika ako se to dogodi.
English: This effect was found to be similar across all doses.
Croatian: Otkriveno je da je ovaj učinak sličan pri svim dozama.
English: Date of latest renewal: 26 August 2013
Croatian: Datum posljednje obnove odobrenja: 26. kolovoza 2013.
English: Most hallucinations are visual.
Croatian: Većina halucinacija su vizualne.
English: However, these studies did not indicate direct or indirect harmful effects with respect to male fertility.
Croatian: Međutim, ova ispitivanja nisu ukazala na izravne ili neizravne štetne učinke s obzirom na mušku plodnost.
English: OF THE SIGHT AND REACHOF CHILDREN Keep out of the sight and reach of children.
Croatian: Stoga će doze biti izražene i u obliku baze pramipeksola i u obliku soli pramipeksola (u zagradama).
English: Simply leave out that dose completely and then take your next dose at the right time.
Croatian: Jednostavno izostavite propuštenu dozu i uzmite sljedeću dozu u pravo vrijeme.
English: Mania and delirium
Croatian: Manija i delirij