FrancophonIA/ELRC3.0 huggingface dataset:
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, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia.
Slovenian: Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več Pri mladostnikih z bipolarno motnjo I so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih: somnolence (23,0 %), ekstrapiramidnih motenj (18,4 %), akatizije (16,0 %) in utrujenosti (11,8 %), ki so bili zelo pogosti (≥ 1/10), ter bolečine v zgornjem predelu trebuha, hitrejšega srčnega utripa, povečanja telesne mase, povečanega apetita, trzanja mišic in diskinezije, ki so bili pogosti (≥ 1/100, < 1/10).
English: • antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine,
Slovenian: • antidepresive ali pripravke rastlinskega izvora proti depresiji in tesnobnosti (kot so fluoksetin,
English: Aripiprazole group showed animprovement of 14.97 on TTS-YGTSS change from baseline to week 10 as compared with an improvement of 9.62 in the placebo group.
Slovenian: teden vidno izboljšanje za 14,97 točk po lestvici TTS-YGTSS od izhodiščne vrednosti, v primerjavi z izboljšanjem za 9,62 točke pri skupini, ki je prejemala placebo.
English: In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
Slovenian: V s placebom nadzorovanih preskušanjih je bila pojavnost akatizije pri bolnikih z bipolarno motnjo pri uporabi aripiprazola 12,1 %, pri uporabi placeba pa 3,2 %.
English: In another 12-week trial, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with lithium.
Slovenian: V drugem 12- tedenskem preskušanju je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 26,6 %, pri bolnikih, ki so se zdravili z litijem pa 17,6 %.
English: A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydroaripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
Slovenian: Raziskava z enim samim odmerkom pri preiskovancih z različno stopnjo jetrne ciroze (razredi A, B in C po Child-Pughu) ni pokazala pomembnega učinka okvare jeter na farmakokinetiko aripiprazola in dehidroaripiprazola.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for Aripiprazole Sandoz is 10 mg/day administered on a once-a-day schedule without regard to meals.
Slovenian: Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več: priporočeni odmerek zdravila Aripiprazol Sandoz je 10 mg enkrat na dan ne glede na obrok hrane.
English: Overall, 1.3% of aripiprazoletreated patients reported cerebrovascular adverse reactions compared with 0.6% of placebo-treated patients in these trials.
Slovenian: V celoti so v teh preskušanjih cerebrovaskularne neželene učinke zabeležili pri 1,3 % bolnikov, zdravljenih z aripiprazolom, in pri 0,6 % bolnikov, ki so dobivali placebo.
English: Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should be taken when these medicinal products are co-administered.
Slovenian: Kljub pogosti sočasni obolevnosti za bipolarno motnjo I in motnjo pomankanja pozornosti je na voljo zelo malo podatkov o sočasni uporabi aripiprazola in stimulansov.
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.
Slovenian: Manične epizode pri bipolarni motnji I pri otrocih in mladostnikih Uporabo aripiprazola so raziskovali v 30-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 296 otrok in mladostnikov (10-17 let), ki so ustrezali kriterijem DSM-IV za bipolarno motnjo I z maničnimi ali mešanimi epizodami s psihotičnimi lastnostmi ali brez njih, in so imeli v izhodišču oceno ≥ 20 po lestvici Y-MRS. Izmed bolnikov, ki so bili vključeni v primarno analizo učinkovitosti, je imelo 139 bolnikov sočasno tudi diagnozo motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD - Attention deficit hyperactivity disorder).
English: Schizophrenia in adolescents aged 15 years and older: the recommended dose for Aripiprazole Sandoz is 10 mg/day administered on a once-a-day schedule without regard to meals.
Slovenian: Shizofrenija pri mladostnikih, starih 15 let in več: priporočeni odmerek zdravila Aripiprazol Sandoz je 10 mg enkrat na dan ne glede na obroke hrane.
English: UNIQUE IDENTIFIER - 2D BARCODE [Only Carton for bottle:]
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA [Samo za zunanjo ovojnino plastenke:] Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: Sandoz d..d Pārstāvniecība Latvijā K.Valdemāra iela 33-30
Slovenian: Latvija Sandoz d..d Pārstāvniecība Latvijā
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.
Slovenian: V dolgotrajni 26-tedenski vzdrževalni fazi s placebom nadzorovanega preskušanja je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 18,2 %, pri bolnikih, ki so prejemali placebo pa 15,7 %.
English: 18 years and presented an average score of 29 on TTS-YGTSS at baseline.
Slovenian: Bolniki so bili stari od 6 do 18 let, njihov povprečni izhodiščni rezultat na lestvici TTS-YGTSS pa je bil 29.
English: These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole Sandoz, you should see your doctor.
Slovenian: Če opazite kakršen koli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Aripiprazol Sandoz, obiščite zdravnika.
English: It may harm them, even iftheirsignsof illnessarethesameasyours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
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.
Slovenian: V drugem dolgoročnem 26-tedenskem nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 14,8 % in pri bolnikih, zdravljenih z olanzapinom, 15,1 %.
English: Patients were 6
Slovenian: Starejši bolniki
English: How to take Aripiprazole Sandoz
Slovenian: Kako jemati zdravilo Aripiprazol Sandoz
English: Excipient(s) with known effect 132.33 mg lactose monohydrate per tablet.
Slovenian: Pomožna(e) snov(i) z znanim učinkom 132,33 mg laktoze monohidrat na tableto
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)
Slovenian: Aripiprazol Sandoz 20 mg tablete EU/1/15/1029/043 (14 tablet) EU/1/15/1029/044 (28 tablet) EU/1/15/1029/045 (49 tablet) EU/1/15/1029/046 (56 tablet) EU/1/15/1029/047 (98 tablet)
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
Slovenian: EU/1/15/1029/043 14 tablet EU/1/15/1029/044 28 tablet EU/1/15/1029/045 49 tablet EU/1/15/1029/046 56 tablet EU/1/15/1029/047 98 tablet
English: venlafaxine, St. John's Wort)
Slovenian: paroksetin, venlafaksin, šentjanževka),
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.
Slovenian: Pri dveh dolgotrajnih preskušanjih pri mladostnikih (starosti od 13 do 17 let) s shizofrenijo in bipolarno motnjo, ki so se zdravili z aripiprazolom, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah 37,0 % (< 3 ng/ml) in pri moških (< 2 ng/ml) 59,4 %.
English: Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Slovenian: Zdravilo Aripiprazol Sandoz je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več.
English: Aripiprazole Sandoz contains lactose
Slovenian: Zdravilo Aripiprazol Sandoz vsebuje laktozo
English: Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n=99, placebo: n=44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weightbased treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Slovenian: Tiki, povezani s Tourettovim sindromom, pri pediatričnih bolnikih (glejte poglavje 4.2) Učinkovitost aripiprazola je bila raziskana pri pediatrični populaciji s Tourettovo motnjo (aripiprazol: n = 99, placebo: n = 44) v 8-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, zasnovani z zdravljenimi skupinami, ki so prejemale nespremenjen odmerek glede na telesno maso posameznika v razponu od 5 mg/dan do 20 mg/dan, z začetnim odmerkom 2 mg. Bolniki so bili stari od 7 do 17 let, povprečni izhodiščni rezultat njihovega števila tikov po skupni oceni resnosti tikov na lestvici TTS-YYGTSS (angl. Total Tic Severity Score - Yale Global Tic Severity Scale) pa je bil 30.
English: What Aripiprazole Sandoz tablets look like and contents of the pack´
Slovenian: Izgled zdravila Aripiprazol Sandoz in vsebina pakiranja
English: Excipient(s) with known effect 71.02 mg lactose monohydrate per tablet.
Slovenian: Pomožna(e) snov(i) z znanim učinkom 71,02 mg laktoze monohidrat na tableto
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.
Slovenian: Pri populaciji mladostnikov (starosti od 13 do 17 let) s shizofrenijo, ki so največ 72 mesecev izpostavljeni apriprazolu 5 do 30 mg, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah (< 3 ng/ml) 25,6 % in pri moških (< 2 ng/ml) 45,0 %.
English: Tel: +420 225 775 111 office.cz@sandoz.com
Slovenian: CZ-140 00 Praha 4 - Nusle Tel: +420 225 775 111 office.cz@sandoz.com
English: Aripiprazole Sandoz 20 mg tablets Each tablet contains 20 mg aripiprazole.
Slovenian: Aripiprazol Sandoz 20 mg tablete Ena tableta vsebuje 20 mg aripiprazola.
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4)
Slovenian: Psihiatrične motnje nespečnost anksioznost nemir depresija hiperseksualnost poskus samomora, misli na samomor in samomor (glejte poglavje 4.4) patološko hazardiranje
English: Blister packs in cartons: 14, 28, 49, 56, 98 tablets
Slovenian: Aripiprazol Sandoz 20 mg tabletePretisni omoti v škatlah: 14, 28, 49, 56, 98 tablet
English: • diarrhoea,
Slovenian: sladkorna bolezen,
English: Excipient(s) with known effect 196.50 mg lactose monohydrate per tablet.
Slovenian: Pomožna(e) snov(i) z znanim učinkom 196,50 mg laktoze monohidrat na tableto
English: Aripiprazole Sandoz 30 mg tablets Each tablet contains 30 mg aripiprazole.
Slovenian: Aripiprazol Sandoz 30 mg tablete Ena tableta vsebuje 30 mg aripiprazola.
English: Excipient(s) with known effect 97.75 mg lactose monohydrate per tablet.
Slovenian: Pomožna(e) snov(i) z znanim učinkom 97,75 mg laktoze monohidrat na tableto
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.
Slovenian: V populaciji mladostnikov s shizofrenijo (13-17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
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.
Slovenian: Tablete Aripiprazol Sandoz 20 mg so bele okrogle tablete s približnim premerom 7,8 mm, z vtisnjeno oznako “SZ” na eni strani in “448” na drugi strani.
English: In a 26- week, 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) on aripiprazole (n= 18, or 13% of evaluable patients), compared to olanzapine (n= 45, or 33% of evaluable patients).
Slovenian: za vsaj 5,6 kg pri povprečni izhodiščni masi ~ 80,5 kg) značilno redkejše pri bolnikih, ki so dobivali aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
English: In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo):
Slovenian: V kratkotrajnem, s placebom nadzorovanem kliničnem preskušanju, ki je vključevalo 302 mladostnika (13-17 let) s shizofrenijo, so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih neželenih učinkov, ki so bili pri mladostnikih, ki so prejemali aripiprazol, pogostejši kot pri odraslih, ki so prejemali aripiprazol (in pogostejši kot pri placebu): somnolenca/sedacija in ekstrapiramidne motnje so bili zelo pogosti (≥ 1/10), suha usta, povečan apetit in ortostatska hipotenzija pa pogosti (≥ 1/100, < 1/10) neželeni učinki.
English: Each tablet contains 20 mg of aripiprazole.
Slovenian: Ena tableta vsebuje 20 mg aripiprazola.
English: Excipient(s) with known effect 65.97 mg lactose monohydrate per tablet.
Slovenian: Pomožna(e) snov(i) z znanim učinkom 65,97 mg laktoze monohidrat na tableto
English: Pathological gambling Impulse-control disorders Binge eating
Slovenian: Neznana pogostnost motnje nadzora impulzov kompulzivno prenajedanje kompulzivno nakupovanje poriomanija agresija agitacija živčnost
English: Musculoskeletal and connective tissue disorders
Slovenian: Neznana pogostnost in vezivnega tkiva togost
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Slovenian: • Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat, rdeči železov oksid (E172).
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.
Slovenian: • Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat, indigotin (E132).
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.
Slovenian: Bele, okrogle, tablete s približnim premerom 7,8 mm, z vtisnjeno oznako “SZ” na eni strani in “448” na drugi strani.
English: Rhabdomyolysis Myalgia Stiffness
Slovenian: Bolezni mišičnoskeletnega sistema rabdomioliza mialgija
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.
Slovenian: Modre, lisaste, okrogle tablete s približnim premerom 6,0 mm, z vtisnjeno oznako “SZ” na eni strani in “444” na drugi strani.
English: Aripiprazole Sandoz 5 mg tablets Each tablet contains 5 mg aripiprazole.
Slovenian: Aripiprazol Sandoz 5 mg tablete Ena tableta vsebuje 5 mg aripiprazola.
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.
Slovenian: Rumene, lisaste, okrogle tablete s približnim premerom 7,0 mm, z vtisnjeno oznako “SZ” na eni strani in “447” na drugi strani.
English: OUTER CARTON FOR BOTTLE AND LABEL FOR BOTTLE
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA OVOJNINA ZA PLASTENKO IN NALEPKA ZA PLASTENKO
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.
Slovenian: Rožnate, lisaste, okrogle tablete s približnim premerom 9,0 mm, z vtisnjeno oznako “SZ” na eni strani in “449” na drugi strani.
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.
Slovenian: Tablete Aripiprazol Sandoz 30 mg so rožnate lisaste okrogle tablete s približnim premerom 9,0 mm, z vtisnjeno oznako “SZ” na eni strani in “449” na drugi strani.
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.
Slovenian: Tablete Aripiprazol Sandoz 5 mg so modre lisaste okrogle tablete s približnim premerom 6,0 mm, z vtisnjeno oznako “SZ” na eni strani na eni strani in “444” na drugi strani.
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.
Slovenian: Tablete Aripiprazol Sandoz 15 mg so rumene lisaste okrogle tablete s približnim premerom 7,0 mm, z vtisnjeno oznako “SZ” na eni strani in “447” na drugi strani.
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.
Slovenian: V pediatrični populaciji z bipolarno motnjo (10-17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa
English: Aripiprazole Sandoz 15 mg tablets Each tablet contains 15 mg aripiprazole.
Slovenian: Aripiprazol Sandoz 15 mg tablete Ena tableta vsebuje 15 mg aripiprazola.
English: • seizure,
Slovenian: Pri odmerkih,
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.
Slovenian: Rožnate, lisaste, okrogle tablete s približnim premerom 6,0 mm, z vtisnjeno oznako “SZ” na eni strani in “446” na drugi strani.
English: Renal impairment
Slovenian: Jeterna okvara
English: Aripiprazole Sandoz 20 mg tablets
Slovenian: Aripiprazol Sandoz 20 mg tablete
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.
Slovenian: • Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat, rumen železov oksid.
English: These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Sandoz; if you get any unusual symptom taking any of these medicines together with Aripiprazole Sandoz you should see your doctor.
Slovenian: Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila Aripiprazol Sandoz.
English: Aripiprazole Sandoz 10 mg tablets Each tablet contains 10 mg aripiprazole.
Slovenian: Aripiprazol Sandoz 10 mg tablete Ena tableta vsebuje 10 mg aripiprazola.
English: Aripiprazole Sandoz 30 mg tablets
Slovenian: Aripiprazol Sandoz 30 mg tablete
English: Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section
Slovenian: Tudi pri aripiprazolu se lahko pojavijo preobčutljivostne reakcije v obliki simptomov alergije (glejte poglavje 4.8).
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.
Slovenian: Tablete Aripiprazol Sandoz 10 mg so rožnate lisaste okrogle tablete s približnim premerom 6,0 mm, z vtisnjeno oznako “SZ” na eni strani in “446” na drugi strani.
English: Pancreatitis Dysphagia Diarrhoea
Slovenian: Očesne bolezni zamegljen vid diplopija okulogirna kriza
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 20 mg
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.
Slovenian: • Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of aripiprazole.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 20 mg aripiprazola.
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 30 mg
English: Aripiprazole Sandoz 10 mg tablets
Slovenian: Aripiprazol Sandoz 10 mg tablete
English: Other medicines and Aripiprazole Sandoz
Slovenian: Shranjevanje zdravila Aripiprazol Sandoz
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 5 mg
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Sandoz 30 mg tablete aripiprazol
English: Aripiprazole Sandoz 5 mg tablets
Slovenian: Aripiprazol Sandoz 5 mg tablete
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanji ovoj: Aripiprazol Sandoz 30 mg
English: Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Slovenian: Aripiprazol Sandoz 5 mg tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat indigotin (E132)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1029/042
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Sandoz 20 mg tablete aripiprazol
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)
Slovenian: Aripiprazol Sandoz 5 mg tablete EU/1/15/1029/001 (10 tablet) EU/1/15/1029/002 (14 tablet) EU/1/15/1029/003 (16 tablet) EU/1/15/1029/004 (28 tablet) EU/1/15/1029/005 (30 tablet) EU/1/15/1029/006 (35 tablet) EU/1/15/1029/007 (56 tablet) EU/1/15/1029/008 (70 tablet) EU/1/15/1029/009 (14 x 1 tablet) EU/1/15/1029/010 (28 x 1 tablet) EU/1/15/1029/011 (49 x 1 tablet) EU/1/15/1029/012 (56 x 1 tablet) EU/1/15/1029/013 (98 x 1 tablet) EU/1/15/1029/014 (100 tablet)
English: Aripiprazole Sandoz 15 mg tablets
Slovenian: Aripiprazol Sandoz 15 mg tablete