FrancophonIA/ELRC3.0 huggingface dataset:
English: Pathological gambling and other impulse control disorders Pathological gambling, hypersexuality, compulsive shopping and binge or compulsive eating can occur in patients treated with aripiprazole (see section 4.4).
Croatian: U bolesnika liječenih aripiprazolom mogu se razviti patološko kockanje, hiperseksualnost, kompulzivno kupovanje i kompulzivno prejedanje (vidjeti dio 4.4).
English: Potential for other medicinal products to affect aripiprazole A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Croatian: H2 receptora, smanjuje brzinu apsorpcije aripiprazola, ali taj se učinak ne smatra klinički značajnim.
English: If you have the impression that the effect of Aripiprazole Zentiva is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Zentiva prejak ili preslab, obratite se svom liječniku ili ljekarniku.
English: Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
Croatian: I te za prevenciju nove manične epizode u odraslih osoba s pretežno maničnim epizodama u kojih su prethodne manične epizode odgovorile na liječenje aripiprazolom (vidjeti dio 5.1).
English: In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Croatian: U tri kratkotrajna (4 - 6 tjedana), placebom kontrolirana ispitivanja koja su uključila 1228 odraslih bolesnika s pozitivnim ili negativnim simptomima shizofrenije, aripiprazol je bio povezan sa statistički značajno većim poboljšanjima psihotičnih simptoma u usporedbi s placebom.
English: Recurrence prevention of manic episodes in Bipolar I Disorder For preventing recurrence of manic episodes in patients who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose.
Croatian: I Za prevenciju relapsa maničnih epizoda u bolesnika koji već uzimaju aripiprazol u obliku monoterapije ili kombinirane terapije, nastavite s primjenom terapije u istoj dozi.
English: Bucuresti
Croatian: Bukurešt
English: Aripiprazole Zentiva with food, drink and alcohol This medicine can be taken regardless of meals.
Croatian: Aripiprazole Zentiva s hranom, pićem i alkoholom
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107%, while Cmax was unchanged.
Croatian: U kliničkom ispitivanju sa zdravim ispitanicima, jaki inhibitor CYP2D6 (kinidin) povećao je površinu ispod krivulje (AUC) aripiprazola za 107 %, dok je maksimalna koncentracija (Cmax) ostala neizmijenjena.
English: In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients.
Croatian: U dugotrajnoj fazi terapije održavanja u trajanju od 26 tjedana u sklopu jednog placebom kontroliranog ispitivanja, incidencija EPS-a bila je 18,2 % u bolesnika liječenih aripiprazolom i 15,7 % u bolesnika koji su primali placebo.
English: In a 26week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg)
Croatian: U 26-tjednom, olanzapinom kontroliranom, dvostruko slijepom, multinacionalnom ispitivanju shizofrenije koje je uključilo 314 odraslih bolesnika i gdje je primarna mjera ishoda bilo povećanje tjelesne težine, značajno manje bolesnika imalo je povećanje tjelesne težine od najmanje 7 % u odnosu na početnu vrijednost (tj. prirast od najmanje 5,6 kg na prosječnu početnu težinu od ~80,5 kg) u skupini na aripiprazolu (n = 18, ili 13 % bolesnika koji su se mogli procijeniti) u usporedbi sa skupinom koja je uzimala olanzapin (n = 45, ili 33 % bolesnika koji su se mogli procijeniti).
English: In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13 - 17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Croatian: U šestotjednom, placebom kontroliranom ispitivanju u koje su bila uključena 302 adolescentna bolesnika sa shizofrenijom (u dobi od 13 do 17 godina) i prisutnim pozitivnim ili negativnim simptomima, aripiprazol je bio povezan sa statistički značajno većim poboljšanjem psihotičnih simptoma u usporedbi s placebom.
English: • cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or “mini” stroke, abnormal blood pressure
Croatian: • srčanih i krvožilnih bolesti, srčanih ili krvožilnih bolesti u obitelji, moždanog udara ili „mini“
English: In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
Croatian: U dva trotjedna, placebom kontrolirana ispitivanja monoterapije fleksibilnom dozom u bolesnika s maničnom ili miješanom epizodom bipolarnog poremećaja tipa I, aripiprazol je pokazao superiornu djelotvornost u odnosu na placebo u smanjenju maničnih simptoma tijekom 3 tjedna.
English: • low levels of white blood cells;
Croatian: • nizak broj bijelih krvnih stanica
English: In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.
Croatian: U dugotrajnom placebom kontroliranom ispitivanju u trajanju od 26 tjedana, incidencija EPS-a bila je 19 % u bolesnika liječenih aripiprazolom i 13,1 % u bolesnika koji su primali placebo.
English: • fast heart beat,
Croatian: • ubrzani otkucaji srca,
English: strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) a tendency to wander away.
Croatian: - prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi),
English: Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (10 - 17 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score ≥ 20 at baseline.
Croatian: I u djece i adolescenata Aripiprazol se ispitivao u 30-tjednom placebom kontroliranom ispitivanju u kojem je sudjelovalo 296 djece i adolescenata (10-17 godina) koji su zadovoljavali DSM-IV kriterije za bipolarni poremećaj tipa
English: Excipient with known effect: each orodispersible tablet contains 55.5 mg of lactose (as monohydrate) and 1.97 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna raspadljiva tableta za usta sadrži 55.5 mg laktoze (u obliku hidrata) i 1.97 mg natrija.
English: In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapine-treated patients.
Croatian: U drugom dugotrajnom kontroliranom ispitivanju od 26 tjedana, incidencija EPS-a bila je 14,8 % u bolesnika liječenih aripiprazolom i 15,1 % u bolesnika liječenih olanzapinom.
English: The orodispersible tablets may be used as an alternative to Aripiprazole Zentiva tablets for patients who have difficulty swallowing Aripiprazole Zentiva tablets (see section 5.2).
Croatian: Raspadljive tablete za usta mogu se primjenjivati kao zamjena za Aripiprazole Zentiva tablete u onih bolesnika kojima je teško progutati Aripiprazole
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, acesulfame potassium, mango flavour, magnesium stearate.
Croatian: Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, krospovidon, hidroksipropilceluloza, bezvodni koloidni silicijev dioksid, umrežena karmelozanatrij, acesulfamkalij, aroma manga, magnezijev stearat.
English: In both of these short term trials, the clinical relevance of the efficacy findings has not been established, considering the magnitude of treatment effect compared to the large placebo effect and the unclear effects regarding psycho-social functioning.
Croatian: S obzirom na veličinu terapijskog učinka u odnosu na veliki učinak placeba i nejasne učinke u pogledu psihosocijalnog funkcioniranja, u ova dva kratkotrajna ispitivanja nije ustanovljena klinička važnost utvrđene djelotvornosti.
English: • Pain killers (such as tramadol and pethidine) used for pain relief
Croatian: • lijekovi protiv bolova (kao što su tramadol i petidin) koji se primjenjuju za ublažavanje boli
English: Talk to your doctor before taking Aripiprazole Zentiva.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete lijek Aripiprazole Zentiva.
English: Each orodispersible tablet contains 10 mg/15 mg/30 mg of aripiprazole.
Croatian: Jedna raspadljiva tableta za usta sadrži 10 mg/15 mg/30mg aripiprazola.
English: • slower heart beat,
Croatian: • usporeni otkucaji srca,
English: How to take Aripiprazole Zentiva
Croatian: Kako uzimati lijek Aripiprazole Zentiva
English: In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, who were partially non-responsive to lithium or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole as adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium or valproate monotherapy.
Croatian: I sa ili bez psihotičnih značajki i djelomičnim nedostatkom odgovora na monoterapiju litijem ili valproatom tijekom 2 tjedna pri terapijskim razinama tih lijekova u serumu, dodatak aripiprazola kao adjuvantne terapije pokazao je superiornu djelotvornost u smanjenju maničnih simptoma u odnosu na monoterapiju litijem ili valproatom.
English: 14 orodispersible tablets
Croatian: 14 raspadljivih tableta za usta
English: White to off-white capsule shaped uncoated tablets with ‘30' debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm.
Croatian: Bijele do bjelkaste, neobložene tablete u obliku kapsule, s utisnutom oznakom '30' s jedne strane i razdjelnom crtom s druge strane, dimenzija približno 15,5 x 8 mm.
English: Excipient with known effect: each orodispersible tablet contains 111 mg of lactose (as monohydrate) and 3.93 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna raspadljiva tableta za usta sadrži 111 mg laktoze (u obliku hidrata) i 3.93 mg natrija.
English: Excipient with known effect: each tablet contains 198 mg of lactose (as monohydrate) and 5.62 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 198 mg laktoze (u obliku hidrata) i 5.62 mg natrija.
English: Hyponatremia Anorexia Weight decreased Weight gain
Croatian: Poremećaji metabolizma i prehrane šećerna bolest hiperglikemija hiponatremija anoreksija smanjena tjelesna težina povećanje tjelesne težine
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4) Pathological gambling Impulse-control disorders Binge eating
Croatian: Psihijatrijski poremećaji nesanica anksioznost nemir depresija hiperseksualnost pokušaj samoubojstva, suicidalne misli i počinjeno samoubojstvo (vidjeti dio patološko kockanje poremećaji kontrole nagona kompulzivno prejedanje kompulzivno kupovanje poriomanija agresija agitacija nervoza
English: Aripiprazole Zentiva contains lactose
Croatian: Aripiprazole Zentiva sadrži natrij
English: Excipient with known effect: each tablet contains 33 mg of lactose (as monohydrate) and 0.94 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 33 mg laktoze (u obliku hidrata) i 0.94 mg natrija.
English: How to store Aripiprazole Zentiva
Croatian: Kako čuvati lijek Aripiprazole Zentiva
English: Neuroleptic Malignant Syndrome (NMS) Grand mal convulsion Serotonin syndrome Speech disorder
Croatian: Poremećaji živčanog sustava akatizija ekstrapiramidalni poremećaj tremor glavobolja sedacija somnolencija omaglica tardivna diskinezija distonija neuroleptički maligni sindrom (NMS) konvulzije tipa grand mal serotoninski sindrom poremećaj govora
English: In the adolescent (13 - 17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 25.6% and 45.0%, respectively.
Croatian: U populaciji adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom koji su bili izloženi aripiprazolu u dozi od 5 do 30 mg do 72 mjeseca, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 25,6 %, a u mladića (< 2 ng/ml) 45,0 %.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate.
Croatian: Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, krospovidon, hidroksipropilceluloza, bezvodni koloidni silicijev dioksid, umrežena karmelozanatrij, magnezijev stearat.
English: Excipient with known effect: each tablet contains 66 mg of lactose (as monohydrate) and 1.87 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 66 mg laktoze (u obliku hidrata) i 1.87 mg natrija.
English: The safety and efficacy of aripiprazole in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established.
Croatian: Sigurnost i djelotvornost aripiprazola u liječenju shizofrenije ili maničnih epizoda kod bipolarnog poremećaja tipa
English: • Antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
Croatian: • antidepresive ili biljne lijekove koji se primjenjuju za liječenje depresije i tjeskobe (kao što su fluoksetin, paroksetin, venlafaksin, gospina trava)
English: Blood glucose fluctuation Increased creatine phosphokinase
Croatian: Pretrage povišena glukoza u krvi povišen glikirani hemoglobin fluktuacija glukoze u krvi povišena vrijednost kreatin fosfokinaze
English: Excipient with known effect: each tablet contains 99 mg of lactose (as monohydrate) and 2.81 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 99 mg laktoze (u obliku hidrata) i 2.81 mg natrija.
English: Excipient with known effect: each orodispersible tablet contains 37 mg of lactose (as monohydrate) and 1.31 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom: jedna raspadljiva tableta za usta sadrži 37 mg laktoze (u obliku hidrata) i 1.31 mg natrija.
English: The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 16% in aripiprazole + lithium and 18% in aripiprazole + valproate compared to 45% in placebo + lithium and 19% in placebo + valproate.
Croatian: + valproat u odnosu na 45 % kod kombinacije placebo + litij te 19 % kod kombinacije placebo + valproat.
English: Mean changes in body weight in adolescents with Bipolar I Disorder at 12 and 30 weeks for aripiprazole were 2.4 kg and 5.8 kg, and for placebo 0.2 kg and 2.3 kg, respectively.
Croatian: I iznosile su 2,4 kg za aripiprazol i 0,2 kg za placebo u 12. tjednu odnosno 5,8 kg za aripiprazol i 2,3 kg za placebo u 30. tjednu.
English: 50 Theodor Pallady Blvd. Bucharest 032266
Croatian: Bukurešt 032266
English: Aripiprazole Zentiva 30 mg tablets
Croatian: Aripiprazole Zentiva 30 mg tablete
English: What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Croatian: Zentiva izgleda i sadržaj pakiranja Aripiprazole Zentiva 5 mg su bijele do bjelkaste, okrugle, plosnate, neobložene tablete ukošenih rubova, s utisnutom oznakom '5' s jedne strane i bez oznake s druge strane, promjera približno 6 mm.
English: In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol at week 12.
Croatian: I sa ili bez psihotičnih značajki, aripiprazol je pokazao superiornu djelotvornost u odnosu na placebo u 3. tjednu, a održanje učinka bilo je usporedivo s onim litija ili haloperidola u 12. tjednu.
English: Manic episodes in Bipolar I Disorder - in a 12-week controlled trial, the incidence of EPS was 23.5% for aripiprazole-treated patients and 53.3% for haloperidol-treated patients.
Croatian: I - u kontroliranom ispitivanju u trajanju od 12 tjedana, incidencija EPS-a bila je 23,5 % u bolesnika liječenih aripiprazolom i 53,3 % u bolesnika liječenih haloperidolom.
English: Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm.
Croatian: Aripiprazole Zentiva 30 mg raspadljive tablete za usta su bijele do bjelkaste, okrugle tablete, s utisnutom oznakom '30' s jedne strane i razdjelnom crtom s druge strane, promjera približno 10,2 mm.
English: Aripiprazole Zentiva 30 mg tablets EU/1/15/1009/016
Croatian: Aripiprazole Zentiva 30 mg tablete EU/1/15/1009/016
English: LIST OF EXCIPIENTS Contains lactose and sodium.
Croatian: Sadrži laktozu hidrat i natrij.
English: In the paediatric bipolar population (10 - 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0% and 53.3%, respectively.
Croatian: U pedijatrijskoj populaciji s bipolarnim poremećajem (10-17 godina), koja je lijeku bila izložena tijekom najviše 30 tjedana, incidencija niskih vrijednosti prolaktina u serumu iznosila je 28,0 % u djevojčica (< 3 ng/ml) i 53,3 % u dječaka (< 2 ng/ml).
English: In the pooled adolescent schizophrenia population (13 - 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 29.5% and 48.3%, respectively.
Croatian: U cjelokupno ispitanoj populaciji adolescenata sa shizofrenijom (u dobi od 13 do 17 godina) koji su primali lijek u trajanju do 2 godine, incidencija niske razine prolaktina u serumu u djevojaka (< 3 ng/ml) bila je 29,5 %, a u mladića (< 2 ng/ml) 48,3 %.
English: Aripiprazole Zentiva 15 mg tablets
Croatian: Aripiprazole Zentiva 15 mg tablete
English: In two long term trials with adolescent (13 - 17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 37.0 % and 59.4 %, respectively.
Croatian: U dva dugotrajna ispitivanja u adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom i u bolesnika s bipolarnim poremećajem liječenih aripiprazolom, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 37,0 %, a u mladića (< 2 ng/ml) 59,4 %.
English: It is important that you carry on taking Aripiprazole Zentiva for as long as your doctor has told you to.
Croatian: Zentiva onoliko dugo koliko Vam je to rekao liječnik.
English: Aripiprazole Zentiva 15 mg orodispersible tablets are white to off-white round flat bevel edged tablets debossed ‘15' on one side and plain on the other side with diameter approx. 8 mm.
Croatian: Aripiprazole Zentiva 15 mg raspadljive tablete za usta su bijele do bjelkaste, okrugle, plosnate tablete ukošenih rubova, s utisnutom oznakom '15' s jedne strane i bez oznake s druge strane, promjera približno 8 mm.
English: Pregnancy, puerperium and perinatal conditions
Croatian: Trudnoća i dojenje
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0%), extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100,
Croatian: I bile su slične onima u odraslih bolesnika, osim sljedećih nuspojava: vrlo često (≥ 1/10) somnolencija (23,0 %), ekstrapiramidni poremećaj (18,4 %), akatizija (16,0 %) i umor (11,8 %); te često (≥ 1/100, < 1/10) bol u gornjem dijelu abdomena, ubrzan srčani ritam, povećanje tjelesne težine, pojačan tek, trzanje mišića i diskinezija.
English: Aripiprazole Zentiva 10 mg tablets
Croatian: Aripiprazole Zentiva 10 mg tablete
English: Aripiprazole Zentiva 10 mg orodispersible tablets White to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm.
Croatian: Aripiprazole Zentiva 10 mg raspadljive tablete za usta Bijele do bjelkaste, okrugle tablete, s utisnutom oznakom '10' s jedne strane i razdjelnom crtom s druge strane, promjera približno 7 mm.
English: Aripiprazole Zentiva 5 mg tablets EU/1/15/1009/001
Croatian: Aripiprazole Zentiva 5 mg tablete EU/1/15/1009/001
English: Aripiprazole Zentiva 10 mg tablets EU/1/15/1009/006
Croatian: Aripiprazole Zentiva 10 mg tablete EU/1/15/1009/006
English: Aripiprazole Zentiva 5 mg tablets
Croatian: Aripiprazole Zentiva 5 mg tablete
English: Aripiprazole Zentiva 15 mg tablets EU/1/15/1009/011
Croatian: Aripiprazole Zentiva 15 mg tablete EU/1/15/1009/011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/021
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1009/021
English: Temperature regulation disorder (e.g. hypothermia, pyrexia)
Croatian: Opći poremećaji i reakcije na mjestu primjene umor poremećaj regulacije tjelesne temperature (npr. hipotermija, pireksija) bol u prsištu periferni edem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/024
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1009/024
English: White to off-white round uncoated tablets with ‘10' debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm.
Croatian: Bijele do bjelkaste, okrugle, neobložene tablete, s utisnutom oznakom '10' s jedne strane i razdjelnom crtom s druge strane, promjera približno 8 mm.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/027
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1009/027
English: Hyperhidrosis
Croatian: fenobarbital)
English: White to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm.
Croatian: Bijele do bjelkaste, okrugle, plosnate, neobložene tablete ukošenih rubova, s utisnutom oznakom '5' s jedne strane i bez oznake s druge strane, promjera približno 6 mm.
English: Aripiprazole Zentiva 30 mg orodispersible tablets EU/1/15/1009/027
Croatian: Aripiprazole Zentiva 30 mg raspadljive tablete za usta EU/1/15/1009/027
English: Aripiprazole Zentiva 10 mg orodispersible tablets EU/1/15/1009/021
Croatian: Aripiprazole Zentiva 10 mg raspadljive tablete za usta EU/1/15/1009/021
English: Aripiprazole Zentiva 15 mg orodispersible tablets EU/1/15/1009/024
Croatian: Aripiprazole Zentiva 15 mg raspadljive tablete za usta EU/1/15/1009/024
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 30 mg orodispersible tablets aripiprazole
Croatian: NAZIV LIJEKA Aripiprazole Zentiva 30 mg tablete aripiprazol