FrancophonIA/ELRC3.0 huggingface dataset:
English: If you take more Aripiprazole Sandoz than you should If you realise you have taken more Aripiprazole Sandoz than your doctor has recommended (or if someone else has taken some of your Aripiprazole Sandoz), contact your doctor right away.
Croatian: Sandoz tableta nego što Vam je preporučio liječnik (ili ako je neka druga osoba popila dio Vašeg lijeka Aripiprazol
English: Schizophrenia: the recommended starting dose for Aripiprazole Sandoz is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.
Croatian: Sandoz je 10 ili 15 mg/dan uz dozu održavanja od 15 mg/dan koja se primjenjuje jedanput dnevno neovisno o obrocima.
English: Aripiprazole Sandoz with food, drink and alcohol This medicine can be taken regardless of meals.
Croatian: Sandoz tablete s hranom, pićem i alkoholom
English: Aripiprazole Sandoz 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTERS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE ZA BLISTER
English: Aripiprazole Sandoz is for oral use.
Croatian: Sandoz namijenjen je za peroralnu primjenu.
English: On the basis of the scientific conclusions for aripiprazole the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aripiprazole is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za aripiprazol, CHMP smatra da je omjer koristi i rizika lijeka(ova)
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 (1017 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: In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapinetreated 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: Excipient(s) with known effect 132.33 mg lactose monohydrate per tablet.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom 132,33 mg laktoze hidrata po tableti.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Croatian: Krvožilni poremećaji ortostatska hipotenzija venska tromboembolija (uključujući plućnu emboliju i
English: 18 years and presented an average score of 29 on TTS-YGTSS at baseline.
Croatian: Bolesnici su bili u dobi od 6 do 18 godina i imali su prosječno 29 bodova na ljestvici TTS-YGTSS na početku ispitivanja.
English: Tics associated with Tourette's disorder: the safety and efficacy of Aripiprazole Sandoz in children and adolescents 6 to 18 years of age have not yet been established.
Croatian: Sandoz u djece i adolescenata u dobi od 6 do 18 godina nisu još ustanovljene.
English: : + 359 2 970 47 47 regaffairs.bg@sandoz.com
Croatian: 1407 Sofia, Bulgaria Teл.: + 359 2 970 47 47 regaffairs.bg@sandoz.com
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE ZA BLISTERE
English: Excipient(s) with known effect 71.02 mg lactose monohydrate per tablet.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom 71,02 mg laktoze hidrata po tableti.
English: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets After first opening of the bottle: 3 months
Croatian: Aripiprazol Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablete
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: EU/1/15/1029/043 14 tablets EU/1/15/1029/044 28 tablets EU/1/15/1029/045 49 tablets EU/1/15/1029/046 56 tablets EU/1/15/1029/047 98 tablets
Croatian: EU/1/15/1029/043 14 tableta EU/1/15/1029/044 28 tableta EU/1/15/1029/045 49 tableta EU/1/15/1029/046 56 tableta EU/1/15/1029/047 98 tableta
English: Increased mortality
Croatian: Povećanje tjelesne težine
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.
Croatian: hidroksipropilceluloza, magnezijev stearat, boja indigo carmine aluminium lake (E132).
English: Blister packs in cartons: 14, 28, 49, 56, 98 tablets
Croatian: Aripiprazol Sandoz 20 mg tablete Blisteri u kartonskoj kutiji: 14, 28, 49, 56, 98 tableta
English: Aripiprazole Sandoz contains lactose
Croatian: Sandoz sadrži laktozu
English: Aripiprazole Sandoz 20 mg tablets EU/1/15/1029/043 (14 tablets) EU/1/15/1029/044 (28 tablets) EU/1/15/1029/045 (49 tablets) EU/1/15/1029/046 (56 tablets) EU/1/15/1029/047 (98 tablets)
Croatian: Aripiprazol Sandoz 20 mg tablete EU/1/15/1029/043 (14 tableta) EU/1/15/1029/043 (28 tableta) EU/1/15/1029/043 (49 tableta) EU/1/15/1029/043 (56 tableta) EU/1/15/1029/043 (98 tableta)
English: Irritability associated with autistic disorder: the safety and efficacy of Aripiprazole Sandoz in children and adolescents aged below 18 years have not yet been established.
Croatian: Sandoz u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vanjsko pakiranje: Aripiprazol Sandoz 15 mg
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Aripiprazol Sandoz 5 mg
English: Excipient(s) with known effect 97.75 mg lactose monohydrate per tablet.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom 97,75 mg laktoze hidrata po tableti.
English: Excipient(s) with known effect 196.50 mg lactose monohydrate per tablet.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom 196,50 mg laktoze hidrata po tableti.
English: Excipient(s) with known effect 65.97 mg lactose monohydrate per tablet.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom 65,97 mg laktoze hidrata po tableti.
English: Manic episodes in Bipolar I Disorder: the recommended starting dose for Aripiprazole Sandoz is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Croatian: Sandoz je 15 mg i primjenjuje se jedanput dnevno neovisno o obrocima u obliku monoterapije ili kombinirane terapije (vidjeti dio 5.1).
English: What Aripiprazole Sandoz tablets look like and contents of the pack´
Croatian: Sandoz izgleda i sadržaj pakiranja
English: Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).The safety profile in a 26-week open-label extension trial was similar to that observed in the short-term, placebo-controlled trial.
Croatian: Somnolencija/sedacija i ekstrapiramidni poremećaji bili su prijavljeni vrlo često (≥ 1/10), dok su često bili prijavljeni suha usta, pojačan apetit i ortostatska hipotenzija (≥ 1/100, < 1/10).
English: Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section
Croatian: Aripiprazol može izazvati reakcije preosjetljivosti, čije su značajke alergijski simptomi (vidjeti dio 4.8).
English: White coloured, round shaped tablet, with an approximate diameter of 7.8 mm, debossed with “SZ” on one side and “448” on the other side.
Croatian: Bijela, okrugla tableta, približnog promjera 7,8 mm, s utisnutom oznakom “SZ” na jednoj strani i “448” na drugoj strani.
English: Aripiprazole Sandoz20mg tablets are white coloured, round shaped tablets, with an approximate diameter of 7.8mm, debossed with “SZ” on one side and “448” on the other side.
Croatian: Aripiprazol Sandoz 20 mg tablete su bijele, okrugle tablete, približnog promjera 7,8 mm, s utisnutom oznakom “SZ“ na jednoj strani i “448“ na drugoj strani.
English: How to take Aripiprazole Sandoz
Croatian: Kako uzimati Aripiprazol
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: • cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease,
Croatian: • srčanih i krvožilnih bolesti, srčanih ili krvožilnih bolesti u obitelji, moždanog udara,
English: Yellow coloured, mottled, round shaped tablet, with an approximate diameter of 7.0 mm, debossed with “SZ” on one side and “447” on the other side.
Croatian: Žuta, prošarana, okrugla tableta, približnog promjera 7,0 mm, s utisnutom oznakom “SZ” na jednoj strani i “447” na drugoj strani.
English: Pink coloured, mottled, round shaped tablet, with an approximate diameter of 9.0 mm, debossed with “SZ” on one side and “449” on the other side.
Croatian: Ružičasta, prošarana, okrugla tableta, približnog promjera 9,0 mm, s utisnutom oznakom “SZ” na jednoj strani i “449” na drugoj strani.
English: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Red iron oxide (E172)
Croatian: hidroksipropilceluloza, magnezijev stearat, crveni željezov oksid (E172).
English: Each tablet contains 20 mg of aripiprazole.
Croatian: Jedna tableta sadrži 20 mg aripiprazola.
English: Aripiprazole Sandoz15mg tablets are yellow coloured, mottled, round shaped tablets, with an approximate diameter of 7.0mm, debossed with “SZ” on one side and “447” on the other side.
Croatian: Aripiprazol Sandoz 15 mg tablete su žute, prošarane, okrugle tablete, približnog promjera 7,0 mm, s utisnutom oznakom “SZ“ na jednoj strani i “447“ na drugoj strani.
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.
Croatian: • Drugi sastojci su laktoza hidrat, kukuruzni škrob, mikrokristalična celuloza,
English: Aripiprazole Sandoz 20 mg tablets
Croatian: Aripiprazol Sandoz 20 mg tablete
English: Aripiprazole Sandoz 5 mg tablets are blue coloured, mottled, round shaped tablets, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Croatian: Aripiprazol Sandoz 5 mg tablete su plave, prošarane, okrugle tablete, približnog promjera 6,0 mm, s utisnutom oznakom “SZ“ na jednoj strani i “444“ na drugoj strani.
English: Blue coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Croatian: Plava, prošarana, okrugla tableta, približnog promjera 6,0 mm, s utisnutom oznakom “SZ” na jednoj strani i “444” na drugoj strani.
English: •• feeling aggressive,
Croatian: • agresivnost,
English: Pink coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “446” on the other side.
Croatian: Ružičasta, prošarana, okrugla tableta, približnog promjera 6,0 mm, s utisnutom oznakom “SZ” na jednoj strani i “446” na drugoj strani.
English: obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
Croatian: generalizirani anksiozni poremećaj, opsesivno kompulzivni poremećaj (OKP) i socijalnu fobiju,
English: Aripiprazole Sandoz30mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 9.0mm, debossed with “SZ” on one side and “449” on the other side.
Croatian: Sandoz 30 mg tablete su ružičaste, prošarane, okrugle tablete, približnog promjera 9,0 mm, s oznakama “SZ“ na jednoj strani i “449“ na drugoj strani.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip fotosenzitivna reakcija alopecija hiperhidroza
English: Grand mal convulsion Serotonin syndrome Speech disorder
Croatian: Serotoninski sindrom
English: Aripiprazole Sandoz 15 mg tablets
Croatian: Aripiprazol Sandoz 15 mg tablete
English: Aripiprazole Sandoz 10 mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 6.0mm, debossed with “SZ” on one side and “446” on the other side.
Croatian: Sandoz 10 mg tablete su ružičaste, prošarane, okrugle tablete, približnog promjera 6,0 mm, s utisnutom oznakom “SZ“ na jednoj strani i “446“ na drugoj strani.
English: Aripiprazole Sandoz 5 mg tablets EU/1/15/1029/001 (10 tablets) EU/1/15/1029/002 (14 tablets) EU/1/15/1029/003 (16 tablets) EU/1/15/1029/004 (28 tablets) EU/1/15/1029/005 (30 tablets) EU/1/15/1029/006 (35 tablets) EU/1/15/1029/007 (56 tablets) EU/1/15/1029/008 (70 tablets) EU/1/15/1029/009 (14 x 1 tablets) EU/1/15/1029/010 (28 x 1 tablets) EU/1/15/1029/011 (49 x 1 tablets) EU/1/15/1029/012 (56 x 1 tablets) EU/1/15/1029/013 (98 x 1 tablets) EU/1/15/1029/014 (100 tablets)
Croatian: Aripiprazol Sandoz 5 mg tablete EU/1/15/1029/001 (10 tableta) EU/1/15/1029/002 (14 tableta) EU/1/15/1029/003 (16 tableta) EU/1/15/1029/004 (28 tableta) EU/1/15/1029/005 (30 tableta) EU/1/15/1029/006 (35 tableta) EU/1/15/1029/007 (56 tableta) EU/1/15/1029/008 (70 tableta) EU/1/15/1029/009 (14 x 1 tableta) EU/1/15/1029/010 (28 x 1 tableta) EU/1/15/1029/011 (49 x 1 tableta) EU/1/15/1029/012 (56 x 1 tableta) EU/1/15/1029/013 (98 x 1 tableta) EU/1/15/1029/014 (100 tableta)
English: Aripiprazole Sandoz 5 mg tablets
Croatian: Aripiprazol Sandoz 5 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole
Croatian: NAZIV LIJEKA Aripiprazol Sandoz 30 mg tablete aripiprazol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1029/042
English: Schizophrenia in adolescents aged 15 years and older
Croatian: Shizofrenija u adolescenata u dobi od 15 i više godina: preporučena doza za Aripiprazol
English: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Yellow iron oxide (E172)
Croatian: Aripiprazol Sandoz 15 mg tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat žuti željezov oksid (E172)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/061
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1029/061
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole
Croatian: NAZIV LIJEKA Aripiprazol Sandoz 20 mg tablete aripiprazol
English: Salivary hypersecretion Vomiting
Croatian: Nepoznato duboku vensku trombozu) hipertenzija sinkopa
English: Pancreatitis Dysphagia Diarrhoea
Croatian: abnormalnog krvnog tlaka
English: Aripiprazole Sandoz 15 mg tablets EU/1/15/1029/029 (10 tablets) EU/1/15/1029/030 (14 tablets) EU/1/15/1029/031 (16 tablets) EU/1/15/1029/032 (28 tablets) EU/1/15/1029/033 (30 tablets) EU/1/15/1029/034 (35 tablets) EU/1/15/1029/035 (56 tablets) EU/1/15/1029/036 (70 tablets) EU/1/15/1029/037 (14 x 1 tablets) EU/1/15/1029/038 (28 x 1 tablets) EU/1/15/1029/039 (49 x 1 tablets) EU/1/15/1029/040 (56 x 1 tablets) EU/1/15/1029/041 (98 x 1 tablets) EU/1/15/1029/042 (100 tablets)
Croatian: Aripiprazol Sandoz 15 mg tablete EU/1/15/1029/029 (10 tableta) EU/1/15/1029/030 (14 tableta) EU/1/15/1029/031 (16 tableta) EU/1/15/1029/032 (28 tableta) EU/1/15/1029/033 (30 tableta) EU/1/15/1029/034 (35 tableta) EU/1/15/1029/035 (56 tableta) EU/1/15/1029/036 (70 tableta) EU/1/15/1029/037 (14 x 1 tableta) EU/1/15/1029/038 (28 x 1 tableta) EU/1/15/1029/039 (49 x 1 tableta) EU/1/15/1029/040 (56 x 1 tableta) EU/1/15/1029/041 (98 x 1 tableta) EU/1/15/1029/042 (100 tableta)
English: The safety and efficacy of Aripiprazole Sandoz in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established.
Croatian: Sandoz u liječenju shizofrenije ili maničnih epizoda kod bipolarnog poremećaja tipa
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
Croatian: NAZIV LIJEKA Aripiprazol Sandoz 10 mg tablete aripiprazol
English: EU/1/15/1029/015 10 tablets EU/1/15/1029/016 14 tablets EU/1/15/1029/017 16 tablets EU/1/15/1029/018 28 tablets EU/1/15/1029/019 30 tablets EU/1/15/1029/020 35 tablets EU/1/15/1029/021 56 tablets EU/1/15/1029/022 70 tablets EU/1/15/1029/023 14 x 1 tablets EU/1/15/1029/024 28 x 1 tablets EU/1/15/1029/025 49 x 1 tablets EU/1/15/1029/026 56 x 1 tablets EU/1/15/1029/027 98 x 1 tablets
Croatian: EU/1/15/1029/015 10 tableta EU/1/15/1029/016 14 tableta EU/1/15/1029/017 16 tableta EU/1/15/1029/018 28 tableta EU/1/15/1029/019 30 tableta EU/1/15/1029/020 35 tableta EU/1/15/1029/021 56 tableta EU/1/15/1029/022 70 tableta EU/1/15/1029/023 14x1 tableta EU/1/15/1029/024 28x1 tableta EU/1/15/1029/025 49x1 tableta EU/1/15/1029/026 56x1 tableta EU/1/15/1029/027 98x1 tableta
English: Aripiprazole Sandoz 30 mg tablets EU/1/15/1029/048 (10 tablets) EU/1/15/1029/049 (14 tablets) EU/1/15/1029/050 (16 tablets) EU/1/15/1029/051 (28 tablets) EU/1/15/1029/052 (30 tablets) EU/1/15/1029/053 (35 tablets) EU/1/15/1029/054 (56 tablets) EU/1/15/1029/055 (70 tablets) EU/1/15/1029/056 (14 x 1 tablets) EU/1/15/1029/057 (28 x 1 tablets) EU/1/15/1029/058 (49 x 1 tablets) EU/1/15/1029/059 (56 x 1 tablets) EU/1/15/1029/060 (98 x 1 tablets) EU/1/15/1029/061 (100 tablets)
Croatian: Sandoz 30 mg tablete EU/1/15/1029/048 (10 tableta) EU/1/15/1029/049 (14 tableta) EU/1/15/1029/050 (16 tableta) EU/1/15/1029/051 (28 tableta) EU/1/15/1029/052 (30 tableta) EU/1/15/1029/053 (35 tableta) EU/1/15/1029/054 (56 tableta) EU/1/15/1029/055 (70 tableta) EU/1/15/1029/056 (14 x 1 tableta) EU/1/15/1029/057 (28 x 1 tableta) EU/1/15/1029/058 (49 x 1 tableta) EU/1/15/1029/059 (56 x 1 tableta) EU/1/15/1029/060 (98 x 1 tableta) EU/1/15/1029/061 (100 tableta)
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
Croatian: NAZIV LIJEKA Aripiprazol Sandoz 5 mg tablete aripiprazol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1029/028
English: EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets
Croatian: EU/1/15/1029/048 10 tableta EU/1/15/1029/049 14 tableta EU/1/15/1029/050 16 tableta EU/1/15/1029/051 28 tableta EU/1/15/1029/052 30 tableta EU/1/15/1029/053 35 tableta EU/1/15/1029/054 56 tableta EU/1/15/1029/055 70 tableta EU/1/15/1029/056 14 x 1 tableta EU/1/15/1029/057 28 x 1 tableta EU/1/15/1029/058 49 x 1 tableta EU/1/15/1029/059 56 x 1 tableta EU/1/15/1029/060 98 x 1 tableta
English: Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Croatian: Aripiprazol Sandoz 5 mg tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat boja
English: EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets
Croatian: EU/1/15/1029/001 10 tableta EU/1/15/1029/002 14 tableta EU/1/15/1029/003 16 tableta EU/1/15/1029/004 28 tableta EU/1/15/1029/005 30 tableta EU/1/15/1029/006 35 tableta EU/1/15/1029/007 56 tableta EU/1/15/1029/008 70 tableta EU/1/15/1029/009 14x1 tableta EU/1/15/1029/010 28x1 tableta EU/1/15/1029/011 49x1 tableta EU/1/15/1029/012 56x1 tableta EU/1/15/1029/013 98x1 tableta
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM (Samo kutija za bocu:)
English: EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets
Croatian: EU/1/15/1029/029 10 tableta EU/1/15/1029/030 14 tableta EU/1/15/1029/031 16 tableta EU/1/15/1029/032 28 tableta EU/1/15/1029/033 30 tableta EU/1/15/1029/034 35 tableta EU/1/15/1029/035 56 tableta EU/1/15/1029/036 70 tableta EU/1/15/1029/037 14x1 tableta EU/1/15/1029/038 28x1 tableta EU/1/15/1029/039 49x1 tableta EU/1/15/1029/040 56x1 tableta EU/1/15/1029/041 98x1 tableta
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
Croatian: NAZIV LIJEKA Aripiprazol Sandoz 15 mg tablete aripiprazol
English: Hydroxypropyl cellulose
Croatian: hidroksipropilceluloza, magnezijev stearat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1029/014
English: - 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)
Croatian: • nemogućnost odupiranja nagonu, porivu ili iskušenju za vršenje radnji koje bi mogle naškoditi Vama ili drugima, što može uključivati: - snažan nagon za pretjeranim kockanjem usprkos ozbiljnim posljedicama za osobu ili obitelj, - promijenjen ili povećan seksualni interes i ponašanje koje znatno zabrinjava Vas ili druge, na primjer, povećani seksualni poriv, - pretjerano kupovanje ili trošenje koje se ne može kontrolirati, - 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), - sklonost da se odluta.
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.
Croatian: hidroksipropilceluloza, magnezijev stearat, žuti željezov oksid.
English: Aripiprazole Sandoz 20 mg tablets Lactose monohydrate Maize starch
Croatian: Aripiprazol Sandoz 20 mg tablete laktoza hidrat kukuruzni škrob celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat