FrancophonIA/ELRC3.0 huggingface dataset:
English: Vokanamet 150 mg/1000 mg film-coated tablets
Croatian: Vokanamet 150 mg/1000 mg filmom obložene tablete
English: Vokanamet 50 mg/850 mg film-coated tablets
Croatian: Vokanamet 50 mg/850 mg filmom obložene tablete
English: Avoid excessive alcohol intake while taking this medicine since this may increase the risk of lactic acidosis.
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate ovaj lijek jer to može povećati rizik od laktacidoze (vidjeti dio “Upozorenja i mjere opreza”).
English: • Vokanamet 150 mg/850 mg film-coated tablets (tablets) are light yellow, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “418” on the other side.
Croatian: • Vokanamet 150 mg/850 mg filmom obložene tablete (tablete) su svijetložute boje, oblika kapsule, duljine 21 mm, s utisnutim “CM” na jednoj strani i “418” na drugoj strani.
English: Because of the way canagliflozin works, your urine will test positive for sugar (glucose) while you are taking this medicine.
Croatian: Glukoza u mokraći Radi načina na koji djeluje kanagliflozin, Vaša će mokraća dati pozitivan rezultat na šećere (glukozu)
English: Possible signs of low blood sugar are: blurred vision tingling lips trembling, sweating, looking pale a change in mood or feeling anxious or confused.
Croatian: zamagljenje vida trnci usana drhtanje, znojenje, bljedilo promjene raspoloženja, osjećaj tjeskobe ili smetenosti.
English: Consideration may also be given to stopping treatment with Vokanamet in patients that develop events preceding amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Croatian: U bolesnika kod kojih se razviju događaji koji prethode amputaciji poput kožnog čira na donjim ektremitetima, infekcije, osteomijelitisa ili gangrene, u obzir se također može uzeti prekid liječenja lijekom Vokanamet.
English: The reductions in RTG led to increased UGE in subjects with type 2 diabetes treated with either 100 mg or 300 mg once daily of canagliflozin ranging from 77 g/day to 119 g/day across the phase 1 studies; the UGE observed translates to a loss of 308 kcal/day to 476 kcal/day.
Croatian: Smanjenja RTG dovela su do povišenog izlučivanja glukoze urinom u ispitanika s dijabetesom tipa 2 liječenih bilo sa 100 mg ili 300 mg kanagliflozina jednom dnevno u rasponu od 77 g/dan do 119 g/
English: Your blood sugar levels may rise if you stop taking this medicine.
Croatian: Ako prestanete uzimati ovaj lijek, može Vam porasti razina šećera u krvi.
English: Bone fracturee
Croatian: Fraktura kostijue
English: Use in patients at risk for adverse reactions related to volume depletion Due to its mechanism of action, canagliflozin, by increasing urinary glucose excretion (UGE), induces an osmotic diuresis, which may reduce intravascular volume and decrease blood pressure (see section 5.1).
Croatian: inducira osmotsku diurezu, što može reducirati intravaskularni volumen i smanjiti krvni tlak (vidjeti dio 5.1).
English: • a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p = 0.01).
Croatian: 11 događaja/1000 bolesnik-godini, dijeta sama 18 događaja/1000 bolesnik-godini, (p = 0,01).
English: Tell your doctor as soon as possible if you get any signs of low blood sugar.
Croatian: Ako Vam se pojavi bilo koji znak niskog šećera u krvi, obratite se svom liječniku što je prije moguće.
English: Each 150 mg/850 mg tablet contains 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Croatian: Jedna tableta od 150 mg/850 mg sadrži 150 mg kanagliflozina i 850 mg metforminklorida.
English: Each 50 mg/1000 mg tablet contains 50 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Croatian: Jedna tableta od 50 mg/1000 mg sadrži 50 mg kanagliflozina i 1000 mg metforminklorida.
English: Each 50 mg/850 mg tablet contains 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Croatian: Jedna tableta od 50 mg/850 mg sadrži 50 mg kanagliflozina i 850 mg metforminklorida.
English: • insulin or a sulphonylurea (such as glimepiride or glipizide) for diabetes - your doctor may want to reduce your dose in order to avoid your blood sugar level from getting too low
Croatian: • inzulin ili sulfonilureju (poput glimepirida ili glipizida) za liječenje šećerne bolest - liječnik će
English: Each 150 mg/1000 mg tablet contains 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Croatian: Jedna tableta od 150 mg/1000 mg sadrži 150 mg kanagliflozina i 1000 mg metforminklorida.
English: Vokanamet 50 mg/1000 mg film-coated tablets EU/1/14/918/004 (20 tablets) EU/1/14/918/005 (60 tablets) EU/1/14/918/006 (180 tablets)
Croatian: Vokanamet 50 mg/1000 mg filmom obložene tablete EU/1/14/918/004 (20 tableta) EU/1/14/918/005 (60 tableta) EU/1/14/918/006 (180 tableta)
English: Vokanamet 50 mg/850 mg film-coated tablets EU/1/14/918/001 (20 tablets) EU/1/14/918/002 (60 tablets) EU/1/14/918/003 (180 tablets)
Croatian: Vokanamet 50 mg/850 mg filmom obložene tablete EU/1/14/918/001 (20 tableta) EU/1/14/918/002 (60 tableta) EU/1/14/918/003 (180 tableta)
English: Following single and multiple oral doses of canagliflozin to patients with type 2 diabetes, dose-dependent decreases in RTG and increases in UGE were observed.
Croatian: Nakon pojedinačnih i višekratnih oralnih doza kanagliflozina, kod bolesnika s dijabetesom tipa 2,
English: Vokanamet 150 mg/1000 mg film-coated tablets EU/1/14/918/010 (20 tablets)
Croatian: Vokanamet 150 mg/850 mg filmom obložene tablete EU/1/14/918/007 (20 tableta)
English: c Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Croatian: c Osip uključuje pojmove eritemni osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip, pruritički osip, pustularni osip i vezikularni osip.
English: Other special populations
Croatian: Druge posebne populacije Farmakogenetika
English: Cationic medicinal products
Croatian: Kationski lijekovi
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih dodatnih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku,
English: A delayed time to peak plasma concentration was observed for both components (2 hours for canagliflozin and 1 hour for metformin) under fed conditions.
Croatian: (2 sata za kanagliflozin i 1 sat za metformin).
English: • Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure,
Croatian: • Akutna ili kronična bolest koja može izazvati hipoksiju tkiva kao što je: srčano ili respiratorno zatajenje, nedavni infarkt miokarda, šok; • Oštećenje jetrene funkcije, akutno trovanje alkoholom, alkoholizam (vidjeti dijelove 4.2 i 4.5).
English: - 150 mg/1000 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Croatian: - tablete od 150 mg/1000 mg: makrogol (3350), poli(vinilni alkohol), talk, titanijev dioksid (E171), željezov oksid, crveni (E172) i željezov oksid, crni (E172).
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 850 mg metformin hydrochloride.
Croatian: Jedna filmom obložena tableta sadrži kanagliflozin hemihidrat, što odgovara 50 mg kanagliflozina i sadrži 850 mg metforminklorida.
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in Vokanamet-treated patients.
Croatian: U bolesnika liječenih lijekom Vokanamet potreban je oprez kad se započinje s primjenom lijekova koji mogu akutno oštetiti funkciju bubrega (kao što su antihipertenzivi, diuretici i NSAIL-ovi).
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 850 mg metformin hydrochloride.
Croatian: Jedna filmom obložena tableta sadrži kanagliflozin hemihidrat, što odgovara 150 mg kanagliflozina i sadrži 850 mg metforminklorida.
English: In a pooled analysis of eight placebo-controlled and active-controlled studies, the safety profile of canagliflozin in elderly patients was generally consistent with younger patients.
Croatian: sigurnosni profil u starijih bolesnika općenito je u skladu s onim u mlađih bolesnika.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 1000 mg metformin hydrochloride.
Croatian: Jedna filmom obložena tableta sadrži kanagliflozin hemihidrat, što odgovara 50 mg kanagliflozina i sadrži 1000 mg metforminklorida.
English: • vomiting
Croatian: • mučnina
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 1000 mg metformin hydrochloride.
Croatian: Jedna filmom obložena tableta sadrži kanagliflozin hemihidrat, što odgovara 150 mg kanagliflozina i sadrži 1000 mg metforminklorida.
English: Canagliflozin has been observed to inhibit P-gp in vitro.
Croatian: Primijećeno je da kanagliflozin inhibira
English: - 150 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Croatian: Vokanamet 150 mg/850 mg filmom obložene tablete makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, žuti (E172)
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba) • osip ili crvena koža - koji može svrbiti i biti izbočen, uz curenje tekućine ili mjehuriće.
English: Adults with normal renal function (GFR ≥ 90 mL/min) The dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability, using the recommended daily dose of 100 mg or 300 mg canagliflozin and not exceeding the maximum recommended daily dose of metformin orally.
Croatian: Doza lijeka Vokanamet u terapiji snižavanja šećera mora se odrediti za svakog bolesnika ponaosob na temelju dosadašnje terapije, učinkovitosti i podnošljivosti, uz primjenu preporučene dnevne doze od
English: Vokanamet 150 mg/850 mg film-coated tablets EU/1/14/918/007 (20 tablets) EU/1/14/918/008 (60 tablets) EU/1/14/918/009 (180 tablets)
Croatian: Vokanamet 150 mg/1000 mg filmom obložene tablete EU/1/14/918/010 (20 tableta) EU/1/14/918/011 (60 tableta) EU/1/14/918/012 (180 tableta)
English: Difference from glimepiride (adjusted mean) (95% CI)
Croatian: (prilagođena srednja vrijednost) (95%
English: Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin
Croatian: Tablica 5: Rezultati djelotvornosti iz aktivno-kontroliranih ispitivanjaa Usporedba s glimepiridom kao dvojnom terapijom s metforminom (52 tjedna) Kanagliflozin + metformin
English: - 50 mg/1000 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Croatian: Vokanamet 50 mg/1000 mg filmom obložene tablete makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172)
English: Film-coating: - 50 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Croatian: Vokanamet 50 mg/850 mg filmom obložene tablete makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: l Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 2.7% for placebo.
Croatian: l Srednje vrijednosti postotka promjene ureje u krvi u odnosu na početnu bila je 17,1% i 18,0% za kanagliflozin od 100
English: Together you will decide how to continue.
Croatian: Zajedno ćete odlučiti kako nastaviti.
English: How and when to take
Croatian: Kako i kada uzeti
English: This study comprised a total of 665 patients.
Croatian: Ovo ispitivanje uključilo je ukupno 665 bolesnika.
English: Libido decreased (including loss of libido)
Croatian: Smanjeni libido (uključujući gubitak libida)
English: The estimated volume of distribution (Vd/F) is approximately 3200 l.
Croatian: Procijenjeni volumen distribucije(Vd/F) je približno 3200 l.
English: During pivotal trials the greatest improvement was observed within the first 4 weeks.
Croatian: Tijekom pivotalnih ispitivanja najveće je poboljšanje opaženo unutar prva 4 tjedna.
English: Elderly patients (≥65 years of age)
Croatian: Stariji bolesnici (≥65 godina)
English: - You should take the tablet 1-2 hours before you start drinking alcohol.
Croatian: - Trebate uzeti tabletu 1-2 sata prije nego što ćete početi piti alkohol.
English: EU/1/12/815/001 7 tablets EU/1/12/815/002 14 tablets EU/1/12/815/003 28 tablets EU/1/12/815/004 42 tablets EU/1/12/815/005 98 tablets EU/1/12/815/006 49 tablets
Croatian: EU/1/12/815/001 7 tableta EU/1/12/815/002 14 tableta EU/1/12/815/003 28 tableta EU/1/12/815/004 42 tablete EU/1/12/815/005 98 tableta EU/1/12/815/006 49 tableta
English: A high level of alcohol consumption is associated with an increased risk of health and social problems.
Croatian: Visoka razina konzumacije alkohola povezana je s povećanim rizikom od zdravstvenih i društvenih problema.
English: - You can take Selincro with or without food.
Croatian: - Možete uzeti Selincro sa ili bez hrane.
English: The tablet is engraved with ‘S' on one side.
Croatian: Tableta ima ugravirano ‘S' na jednoj strani.
English: How much to take
Croatian: Koju količinu uzeti
English: In this post hoc population, the treatment effect was larger than that in the total population.
Croatian: U toj post hoc populaciji, učinci liječenja bili su veći nego u ukupnoj populaciji.
English: Thereafter, the patient should be asked to record his or her alcohol consumption for approximately two weeks.
Croatian: Nakon toga bi trebalo zamoliti bolesnika da bilježi svoju konzumaciju alkohola tijekom približno 2 tjedna.
English: No unusual pattern of adverse reactions was observed in these settings, but experience is limited.
Croatian: Nisu opaženi neuobičajeni obrasci nuspojava u ovim okolnostima, ali je iskustvo ograničeno.
English: This change is considered unlikely to be of clinical relevance.
Croatian: Smatra se da ova promjena vjerojatno nije od kliničke važnosti.
English: Alcohol dependence occurs when a person has a physical or psychological dependence on the consumption of alcohol.
Croatian: Ovisnost o alkoholu se javlja kad osoba ima fizičku ili psihološku ovisnost o konzumaciji alkohola.
English: Date of first authorisation: 25 February 2013 Date of latest renewal: 10 November 2017
Croatian: Datum posljednje obnove odobrenja: 10. studenoga 2017.
English: An updated RMP shall be submitted annually until renewal.
Croatian: Dopunjeni RMP podnosi se jednom godišnje do obnove.
English: If unusually large doses are required, close observation is necessary.
Croatian: Ako su potrebne neuobičajeno velike doze, pomno promatranje je nužno.
English: However, the frequency of these side effects cannot be estimated from the available data.
Croatian: Međutim, učestalost ovih nuspojava ne može se procijeniti iz dostupnih podataka.
English: Frequencies are defined as: 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), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: 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), ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Les Bouillides Sophia Antipolis 06560 Valbonne France
Croatian: Les Bouillides Sophia Antipolis 06560 Valbonne Francuska
English: Management of an overdose should be observational and symptomatic.
Croatian: Zbrinjavanje predoziranja treba biti opservacijsko i simptomatsko.
English: Selincro can be taken with or without food (see section 5.2).
Croatian: Selincro se može uzeti sa ili bez hrane (vidjeti dio 5.2).
English: Patients with severe hepatic impairment (Child-Pugh classification).
Croatian: Bolesnici s teškim oštećenjem jetre (Child-Pugh klasifikacija).
English: The maximum dose of Selincro is one tablet per day.
Croatian: Maksimalna doza Selincra je jedna tableta dnevno.
English: The film-coated tablet should be swallowed whole.
Croatian: Filmom obložene tablete treba progutati cijele.
English: - You can expect to be able to reduce your alcohol consumption within the first month after you start treatment with Selincro.
Croatian: - Možete očekivati da ćete biti u stanju smanjiti konzumaciju alkohola unutar prvog mjeseca nakon što počnete liječenje Selincrom.
English: At randomisation, these patients consumed such a small amount of alcohol that there was little room for further improvement (floor effect).
Croatian: Ovi su bolesnici u trenutku randomizacije konzumirali toliko male količine alkohola da je bilo malo mjesta za daljnja poboljšanja (floor effect).
English: - Your doctor will follow up with you on a regular basis, for example, monthly after you start treatment with Selincro; the actual frequency will depend on your progress.
Croatian: - Vaš liječnik će Vas redovito nadzirati, na primjer, mjesečno nakon što počnete liječenje Selincrom; stvarna učestalost ovisit će o Vašem napretku.
English: If you take more Selincro than you should
Croatian: Ako uzmete više Selincra nego što ste trebali
English: Malaise Feeling abnormal
Croatian: Malaksalost Abnormalno osjećanje
English: Reduction of alcohol consumption is an intermediate goal on the way to abstinence.
Croatian: Smanjenje konzumacije alkohola je prijelazni cilj na putu do apstinencije.
English: Inform your doctor about any other diseases you may have, for example, depression, seizure, liver or kidney disease.
Croatian: Obavijestite svog liječnika o svim drugim bolestima koje možda imate, na primjer, depresiji, napadajima, bolestima jetre ili bubrega.
English: Patients with severe renal impairment (eGFR <30 ml/min per 1.73 m
Croatian: Bolesnici s teškim oštećenjem bubrega (eGFR <30 ml/min na 1,73 m
English: Somnolence Tremor
Croatian: Somnolencija Tremor
English: If opioids are needed in an emergency, the dose must always be titrated individually.
Croatian: Ako su opioidi potrebni u hitnom stanju, doza uvijek mora biti titrirana individualno.
English: Selincro should not be used in children or adolescents below the age of 18 years because Selincro has not been tested in this age group.
Croatian: Selincro se ne smije primjenjivati u djece ili adolescenata mlađih od 18 godina jer Selincro nije bio ispitan u ovoj dobnoj skupini.
English: If you feel detached from yourself, see or hear things that are not there, and this continues to recur for more than a few days, stop taking Selincro and talk to your doctor.
Croatian: Ako se osjećate odvojenima od samoga sebe, vidite ili čujete stvari koje ne postoje te se to ponavlja kroz više od nekoliko dana, prestanite uzimati Selincro i obratite se svom liječniku.
English: - Do not use this medicine if you notice defects in the tablets, such as chipped or broken tablets.
Croatian: - Ovaj lijek se ne smije upotrijebiti ako primijetite oštećenja tableta, kao što su okrhnute ili slomljene tablete.
English: In some cases, it may be difficult for you to distinguish side effects from the symptoms you may feel when you reduce your alcohol consumption.
Croatian: U nekim će slučajevima biti teško razlikovati nuspojave od simptoma koje ćete možda osjećati nakon što smanjite konzumaciju alkohola.
English: The AUC at the no observed adverse effect level (NOAEL) for these effects was below the human exposure at the recommended clinical dose.
Croatian: AUC pri razini na kojoj se ne uočava štetni učinak (engl. no observed adverse effect level, NOAEL) za ove učinke bio je ispod razine ljudske izloženosti pri preporučenim kliničkim dozama.
English: Clinical data for the use of Selincro under randomised controlled conditions are available for a period of 6 to 12 months.
Croatian: Klinički podaci o uporabi Selincra u randomiziranim kontroliranim uvjetima dostupni su za razdoblje od 6 do 12 mjeseci.
English: These side effects may affect your skills when driving or doing anything that requires you to be alert, including operating machinery.
Croatian: Ove nuspojave mogu utjecati na Vaše sposobnosti tijekom upravljanja vozilima ili obavljanja bilo kakvih aktivnosti koje zahtijevaju Vašu pozornost, uključujući rad sa strojevima.
English: Caution is advised if treatment aimed at reduction of alcohol consumption is started in such patients.
Croatian: Savjetuje se oprez ako se počinje liječenje sa svrhom smanjenja konzumacije alkohola u takvih bolesnika.
English: While these events were generally shortlasting, they could represent alcoholic psychosis, alcohol withdrawal syndrome, or comorbid psychiatric disease.
Croatian: Iako su ovi događaji bili općenito kratkoga trajanja, mogli bi predstavljati alkoholnu psihozu, sindrom ustezanja od alkohola ili komorbidnu psihijatrijsku bolest.
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in alcohol dependence; ATC code: N07BB05
Croatian: Farmakoterapijska skupina: Ostali lijekovi živčanog sustava, lijekovi za liječenje ovisnosti o alkoholu; ATK oznaka: N07BB05
English: Caution is advised if Selincro is prescribed for more than 1 year.
Croatian: Savjetuje se oprez ako se Selincro propisuje dulje od 1 godine.
English: The nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, or carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti ili kancerogenog potencijala.
English: Hallucination (including hallucination auditory, hallucination tactile, hallucination visual, and somatic hallucination)
Croatian: Halucinacije (uključujući auditorne halucinacije, taktilne halucinacije, vizualne halucinacije i somatske halucinacije)
English: 1 year study
Croatian: Jednogodišnje ispitivanje
English: Nalmefene does not exhibit any substantial pharmacokinetic differences between sexes, between young and elderly, or between ethnic groups.
Croatian: Nalmefen ne pokazuje znatne farmakokinetičke razlike između spolova, između mladih i starijih ili između etničkih skupina.
English: Selincro with food and alcohol
Croatian: Selincro s hranom i alkoholom
English: The physician should continue to assess the patient's progress in reducing alcohol consumption, overall functioning, treatment adherence, and any potential side effects.
Croatian: Liječnik treba nastaviti procjenjivati bolesnikov napredak u smanjenju konzumacije alkohola, sveukupno funkcioniranje, pridržavanje liječenja i bilo kakve moguće nuspojave.
English: Your doctor will provide you with counselling to help you keep to your treatment and thereby reduce your alcohol consumption.
Croatian: Vaš liječnik će Vas savjetovati kako bi Vam pomogao da se pridržavate liječenja i time smanjite konzumaciju alkohola.
English: For example, a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.
Croatian: Na primjer, boca vina (750 ml; 12% alkohola u volumenu) sadrži približno 70 g alkohola, a boca piva (330 ml; 5% alkohola u volumenu) sadrži približno 13 g alkohola.
English: Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies.
Croatian: Konfuzno stanje i rijetko, halucinacije i disocijacija, prijavljeni su u kliničkim ispitivanjima.
English: Talk to your doctor or pharmacist before taking Selincro.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Selincro.
English: Intake of a single dose of 450 mg nalmefene has been reported without changes in blood pressure, heart rate, respiration rate, or body temperature.
Croatian: Prijavljeno je uzimanje pojedinačne doze od 450 mg nalmefena bez promjena u krvnom tlaku, srčanom ritmu, brzini disanja ili tjelesnoj temperaturi.
English: No specific study with oral dosing has been conducted in patients ≥65 years of age.
Croatian: Nije provedeno posebno ispitivanje s oralnim doziranjem u bolesnika ≥65 godina.