FrancophonIA/ELRC3.0 huggingface dataset:
English: In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Slovenian: V teh primerih bo zdravnik nadzoroval ledvično delovanje v določenih časovnih presledkih.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 70 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 42 filmsko obloženih tablet 50 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 70 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet 100 filmsko obloženih tablet 112 filmsko obloženih tablet
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance-active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Slovenian: V raziskavah farmakokinetike (PK) posameznega odmerka pri mladih zdravih osebah ni bilo opaziti interakcij učinkovina-učinkovina memantina z gliburidom/metforminom ali donepezilom.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but not in monkeys.
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih so pri glodalcih in psih, ne pa tudi pri opicah,
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer's disease assessment scale (ADAS-cog) (p = 0.003) and CIBIC-plus (p = 0.004) at week 24 (last observation carried forward (LOCF)).
Slovenian: Pri bolnikih, zdravljenih z memantinom, se je pokazal statistično značilno boljši učinek kot pri bolnikih, ki so prejemali placebo, pri primarnih ciljih študije: Lestvica za ocenjevanje Alzheimerjeve bolezni (Alzheimer´s disease assessment scale ali,ADAS-cog) (p = 0,003) in CIBIC-plus (p = 0,004) po 24 tednih (last observation carried forward (LOCF)).
English: Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4- and 6-hydroxymemantine, and 1-nitroso-3,5-dimethyl-adamantane.
Slovenian: Pri človeku so poglavitni metaboliti N-3,5-dimetil-gludantan, izomerna mešanica 4- in 6-hidroksi-memantina in 1-nitrozo-3,5-dimetiladamantana.
English: Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravnik vam bo povedal, ali kljub vaši bolezni lahko varno vozite in varno upravljate strojev.
English: Breast-feeding Women taking Marixino should not breast-feed.
Slovenian: Dojenje Ženske, ki jemljejo zdravilo Marixino, ne smejo dojiti.
English: The usual starting dose is half a tablet once a day (1 x 5 mg) for the first week.
Slovenian: Običajni začetni odmerek je polovica tablete enkrat na dan (1 x 5 mg) v prvem tednu.
English: In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Slovenian: Največji dnevni odmerek je 20 mg na dan. Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, kot sledi:
English: The use of medicinal products called amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Slovenian: Potrebno se je izogibati sočasni uporabi zdravil, kot so amantadin (za zdravljenje Parkinsonove bolezni), ketamin (učinkovina, ki se običajno uporablja kot anestetik), dekstrometorfan (običajno se uporablja za zdravljenje kašlja) in ostali zaviralci receptorjev NMDA.
English: Women taking memantine should not breast-feed.
Slovenian: Ženske, ki jemljejo memantin, naj ne dojijo.
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Slovenian: Pri prevelikem odmerjanju do 140 mg ali pri neznanih odmerkih so se pri bolnikih pokazali simptomi, povezani s centralnim živčnim sistemom (zmedenost, dremavost, zaspanost, vrtoglavica, vznemirjenost, agresivnost, halucinacije in motnje hoje) in/ali prebavili (bruhanje in driska).
English: Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
English: Medicinal product subject to restricted prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: To benefit from your medicine you should take it regularly every day at the same time of the day.
Slovenian: Zdravilo Marixino jemljite peroralno enkrat na dan. Da bi vam zdravilo koristilo, ga morate jemati redno, vsak dan ob istem času.
English: Your doctor should assess your treatment on a regular basis.
Slovenian: Zdravnik mora redno preverjati učinek zdravljenja.
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5 - 1 μmol) with large interindividual variations.
Slovenian: Ob dnevnih odmerkih po 20 mg so v stanju dinamičnega ravnovesja dosežene plazemske koncentracije memantina v razponu od 70 do 150 ng/ml (0,5-1 µmol), ob veliki variabilnosti med posamezniki.
English: How to take Marixino
Slovenian: Kako jemati zdravilo Marixino
English: Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was observed in rodents.
Slovenian: Pri glodalcih so opazili fosfolipidozo v makrofagih v pljučih, ker se je memantin kopičil v lizosomih.
English: Only limited experience with overdose is available from clinical studies and post-marketing experience.
Slovenian: Iz kliničnih študij in izkušenj po prihodu zdravila na trg so na voljo le omejene izkušnje s prevelikim odmerjanjem.
English: In patients with mildly impaired renal function (creatinine clearance 50 - 80 ml/min) no dose adjustment is required.
Slovenian: Pri bolnikih z blago okvaro delovanja ledvic (očistek kreatinina 50-80 ml/min) prilagoditev odmerka ni potrebna.
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p = 0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002).
Slovenian: Po 6 mesečnem zdravljenju z memantinom se je pri opazovanih bolnikih pokazalo izboljšanje v primerjavi s placebom (analiza opazovanih bolnikov, lestvice CIBIC-plus ("Clinician's Interview Based Impression of Change" Vtis sprememb na osnovi kliničnega intervjuja): p = 0,025; lestvica ADCS-ADLsev ("Alzheimer's disease cooperative studyactivities of daily living " Vprašalnik vsakodnevnih aktivnosti): p = 0,003; SIB ("severe impairment battery" oz.
English: In man, about 80 % of the circulating memantine-related material is present as the parent compound.
Slovenian: Pri človeku je okoli 80 % memantina v obtoku v izvorni obliki.
English: Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina.
English: At the beginning of treatment you will start by using half a 10 mg tablet once a day (1 x 5 mg).
Slovenian: Na začetku zdravljenja boste jemali polovico 10-miligramske tablete (1x5 mg) enkrat na dan.
English: There are no or limited amount of data from the use of memantine in pregnant women.
Slovenian: Podatkov o uporabi memantina pri nosečnicah ni oziroma so omejeni.
English: Marixino 10 mg film-coated tablets Each film-coated tablet contains 51.45 mg lactose monohydrate.
Slovenian: Marixino 10 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 51,45 mg laktoze monohidrata.
English: These events have been reported in patients treated with memantine.
Slovenian: Pri bolnikih, zdravljenih z memantinom, so poročali o teh dogodkih.
English: In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme.
Slovenian: Da bi zmanjšali nevarnost pojava neželenih učinkov, odmerek dosegate postopoma, po priporočilu spodnje sheme dnevnega odmerjanja.
English: No adverse reactions of memantine were noted on male and female fertility.
Slovenian: Neželenih učinkov memantina v zvezi s plodnostjo pri moških ali ženskah niso opazili.
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Slovenian: Temeljna študija memantina v monoterapiji pri zdravljenju bolnikov z blago do zmerno Alzheimerjevo boleznijo (skupna ocena ob vključitvi 10 do 22 točk na KPSS) je zajela 403 bolnike.
English: Marixino 20 mg film-coated tablets Each film-coated tablet contains 102.90 mg lactose monohydrate.
Slovenian: Marixino 20 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 102,90 mg laktoze monohidrata.
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) daily dose should be 10 mg per day.
Slovenian: Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30-49 ml/min) naj bo dnevni odmerek 10 mg.
English: These factors include drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers.
Slovenian: Med te dejavnike spadajo izrazite spremembe v prehranjevanju, kot npr. prehod z običajne na vegetarijansko prehrano ali čezmerno zaužitje alkalno delujočih snovi proti želodčni kislini.
English: Also, Marixino may change your reactivity, making driving or operating machinery inappropriate.
Slovenian: Prav tako zdravilo Marixino lahko vpliva na vašo sposobnost odzivanja, zato se vožnja in upravljanje strojev ne priporoča.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja
English: The recommended dose of Marixino for adults and older people is 20 mg once a day.
Slovenian: Za odrasle in starejše osebe je priporočeni odmerek zdravila Marixino 20 mg enkrat na dan.
English: Tabulated list of adverse reactions
Slovenian: Tabelarični povzetek neželenih učinkov
English: Standard clinical procedures to remove active substance material, e.g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
Slovenian: Pri odstranjevanju učinkovine uporabljamo ustrezne standardne klinične postopke, kot so izpiranje želodca, medicinsko oglje (preprečevanje možne entero-hepatične recirkulacije), acidifikacija urina, prisilna diureza.
English: In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg per day.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic (očistek kreatinina 5-29 ml/min) naj bo dnevni odmerek 10 mg.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Marixino reassessed by your doctor on a regular basis.
Slovenian: Vaš zdravnik naj redno ocenjuje klinično korist zdravila Marixino.
English: What Marixino contains - The active substance is memantine hydrochloride.
Slovenian: Kaj vsebuje zdravilo Marixino - Učinkovina je memantinijev klorid.
English: Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
Slovenian: Alkalizacija urina lahko nastopi po izraziti spremembi v prehrani, npr. prehod z običajne na vegetarijansko, ali v primeru prevelikega zaužitja alkalnih učinkovin za uravnavanje želodčne kisline.
English: C-memantine, a mean of 84 % of the dose was recovered within 20 days, more than 99 % being excreted renally.
Slovenian: odmerka v 20 dneh, od tega več kot 99 % preko ledvic.
English: Tablet core: lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, talc (E553b), magnesium stearate (E470b).
Slovenian: Jedro tablete: laktoza monohidrat, mikrokristalna celuloza (E460), brezvodni koloidni silicijev dioksid, smukec (E553b), magnezijev stearat (E470b).
English: Week 4
Slovenian: Od 4. tedna dalje
English: The following Adverse Reactions listed in the table below have been accumulated in clinical studies with memantine and since its introduction in the market.
Slovenian: V preglednici so navedeni podatki o neželenih učinkih memantina, zbrani v kliničnih študijah in od začetka trženja dalje.
English: Latvija KRKA Latvija SIA
Slovenian: Lietuva UAB KRKA Lietuva
English: Administration of Marixino is not recommended in patients with severe hepatic impairment.
Slovenian: Dajanje zdravila Marixino bolnikom s hudo okvaro jeter ni priporočeno.
English: Week 3 (day 15-21) The patient should take one and a half 10 mg film-coated tablets (15 mg) per day for 7 days.
Slovenian: 3. teden (15.-21. dan) Bolnik mora sedem dni jemati eno in pol 10-miligramsko filmsko obloženo tableto (15 mg) na dan.
English: This is increased to one tablet once a day (1 x 10 mg) in the second week and to 1 and a half tablets once a day (1 x 15 mg) in the third week.
Slovenian: V drugem tednu povišamo odmerek na eno tableto enkrat na dan (1 x 10 mg) in v tretjem tednu na eno tableto in pol enkrat na dan. Od četrtega tedna naprej je običajni odmerek dve tableti enkrat na dan (1 x 20 mg).
English: Week 2 (day 8-14) The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Slovenian: 2. teden (8.-14. dan) Bolnik mora sedem dni jemati eno 10-miligramsko filmsko obloženo tableto (10 mg) na dan.
English: Week 1 (day 1-7) The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Slovenian: 1. teden (1.-7. dan) Bolnik mora sedem dni jemati polovico 10-miligramske filmsko obložene tablete (5 mg) na dan.
English: White, oval, biconvex film-coated tablet, scored on one side (tablet length: 12.2-12.9 mm, thickness: 3.5-4.5 mm).
Slovenian: Bele, ovalne, izbočene filmsko obložene tablete z razdelilno zarezo na eni strani (dolžina tablete: 12,2-12,9 mm, debelina: 3,5-4,5 mm).
English: Marixino contains the active substance memantine hydrochloride.
Slovenian: Zdravilo Marixino vsebuje učinkovino memantinijev klorid.
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21 % vs. 11 %, p < 0.0001).
Slovenian: Pri bolnikih, kjer so ocenili hkratno poslabšanje vseh treh domen, so rezultati pokazali statistično značilen učinek memantina pri preprečevanju poslabšanja, saj se je pri dvakrat več bolnikih, ki so prejemali placebo, kot pri bolnikih,
English: Uncommon (may affect up to 1 in 100 people): - Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism).
Slovenian: Utrujenost, glivična okužba, zmedenost, halucinacije, bruhanje, neobičajna hoja, odpovedovanje srca in krvni strdki v venah (tromboza/tromboembolija)
English: For up-titration other tablet strengths are available.
Slovenian: Za lažje povečevanje odmerka so na voljo druge jakosti.
English: Film coating: methacrylic acid-ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, talc (E553b), triacetin, simeticone.
Slovenian: Filmska obloga: kopolimer metakrilne kisline in etilakrilata (1 : 1), natrijev lavrilsulfat, polisorbat 80, smukec (E553b), triacetin, emulzija simetikona.
English: Film coating
Slovenian: Način jemanja
English: Marixino contains lactose
Slovenian: Zdravilo Marixino vsebuje laktozo
English: Venous thrombosis/thromboembolism
Slovenian: Žilne bolezni pogosti hipertenzija občasni venska tromboza/tromboembolija
English: What Marixino looks like and contents of the pack White, oval, biconvex film-coated tablet (tablet length: 15.7-16.4 mm, thickness: 4.7-5.7 mm).
Slovenian: Izgled zdravila Marixino in vsebina pakiranja Bele, ovalne, izbočene filmsko obložene tablete (dolžina tablete: 15,7-16,4 mm, debelina: 4,7-5,7 mm).
English: Marixino 10 mg film-coated tablets Marixino 20 mg film-coated tablets
Slovenian: Marixino 10 mg filmsko obložene tablete Marixino 20 mg filmsko obložene tablete
English: What Marixino looks like and contents of the pack White, oval, biconvex film-coated tablets, scored on one side (tablet length: 12.2-12.9 mm, thickness: 3.5-4.5 mm).
Slovenian: Izgled zdravila Marixino in vsebina pakiranja Bele, ovalne, izbočene filmsko obložene tablete z razdelilno zarezo na eni strani (dolžina tablete: 12,2-12,9 mm, debelina: 3,5-4,5 mm).
English: Marixino 10 mg film-coated tablets
Slovenian: Marixino 10 mg filmsko obložene tablete
English: Marixino should be administered orally once a day and should be taken at the same time every day.
Slovenian: Zdravilo Marixino je treba jemati peroralno enkrat na dan in ga je potrebno zaužiti ob istem času vsak dan. Bolnik lahko filmsko obložene tablete zaužije s hrano ali brez nje.
English: FREQUENCY ADVERSE REACTION
Slovenian: POGOSTNOST NEŽELENI UČINEK
English: Marixino 20 mg film-coated tablets
Slovenian: Marixino 20 mg filmsko obložene tablete
English: Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous Talc (E553b)
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza (E460) brezvodni koloidni silicijev dioksid smukec (E553b) magnezijev stearat (E470b)
English: In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11 - 23) were randomised.
Slovenian: Pri drugi študiji zdravljenja z monoterapijo pri blagi do zmerni Alzheimerjevi bolezni (skupna ocena KPSS ob vključitvi 11 do 23), v katero je bilo zajeto 470 bolnikov, so bili bolniki randomizirani.
English: Dosage in patients with impaired kidney function If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Slovenian: V primeru, da imate ledvično okvaro, vam bo zdravnik prilagodil odmerek v skladu z vašim stanjem.
English: How to store Marixino
Slovenian: Shranjevanje zdravila Marixino
English: This medicinal product contains lactose.
Slovenian: Zdravilo Marixino vsebuje laktozo.
English: Marixino 10 mg film-coated tablets memantine hydrochloride
Slovenian: Marixino 10 mg filmsko obložene tablete memantinijev klorid
English: Marixino 20 mg film-coated tablets memantine hydrochloride
Slovenian: Marixino 20 mg filmsko obložene tablete memantinijev klorid
English: CARTON BOX
Slovenian: ŠKATLA
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Slovenian: V temeljno klinično študijo je bilo vključenih 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo, ki so ob vključitvi pri kratkem preizkusu spoznavnih sposobnosti (KPSS, angl. Mini mental state examination, MMSE) dosegli 3-14 točk.
English: Two 10 mg tablets
Slovenian: 4. teden dve 10-miligramski tableti
English: Film coating: methacrylic acid-ethyl acrylate copolymer (1:1),sodium laurilsulfate, polysorbate 80, talc (E553b), triacetin, simeticone.
Slovenian: Filmska obloga kopolimer metakrilne kisline in etilakrilata (1 : 1) natrijev lavrilsulfat polisorbat 80 smukec (E553b) triacetin emulzija simetikona
English: No cytochrome P 450 catalysed metabolism has been detected in vitro.
Slovenian: Nobeden od teh metabolitov nima antagonističnega učinka na NMDA. In vitro niso zaznali presnove preko citokroma P450.
English: White, oval, biconvex film-coated tablet (tablet length: 15.7-16.4 mm, thickness: 4.7-5.7 mm).
Slovenian: Bele, ovalne, izbočene filmsko obložene tablete (dolžina tablete: 15,7-16,4 mm, debelina: 4,7-5,7 mm).
English: shortness of breath, high blood pressure and drug hypersensitivity.
Slovenian: Glavobol, zaspanost, zaprtje, zvišane vrednosti testov jetrne funkcije, omotica, motnje ravnotežja, zasoplost, visok krvni tlak in preobčutljivost na zdravilo
English: One 10 mg tablet
Slovenian: 2. teden ena 10-miligramska tableta
English: Cardiac failure
Slovenian: Srčne bolezni občasni srčno popuščanje
English: EU/1/13/820/014 14 film-coated tablets EU/1/13/820/015 28 film-coated tablets EU/1/13/820/016 30 film-coated tablets EU/1/13/820/017 42 film-coated tablets EU/1/13/820/018 50 film-coated tablets EU/1/13/820/019 56 film-coated tablets EU/1/13/820/020 60 film-coated tablets EU/1/13/820/021 70 film-coated tablets EU/1/13/820/022 84 film-coated tablets EU/1/13/820/023 90 film-coated tablets EU/1/13/820/024 98 film-coated tablets EU/1/13/820/025 100 film-coated tablets EU/1/13/820/026 112 film-coated tablets
Slovenian: EU/1/13/820/014 14 filmsko obloženih tablet EU/1/13/820/015 28 filmsko obloženih tablet EU/1/13/820/016 30 filmsko obloženih tablet EU/1/13/820/017 42 filmsko obloženih tablet EU/1/13/820/018 50 filmsko obloženih tablet EU/1/13/820/019 56 filmsko obloženih tablet EU/1/13/820/020 60 filmsko obloženih tablet EU/1/13/820/021 70 filmsko obloženih tablet EU/1/13/820/022 84 filmsko obloženih tablet EU/1/13/820/023 90 filmsko obloženih tablet EU/1/13/820/024 98 filmsko obloženih tablet EU/1/13/820/025 100 filmsko obloženih tablet EU/1/13/820/026 112 filmsko obloženih tablet
English: 14 film-coated tablets: EU/1/13/820/001 28 film-coated tablets: EU/1/13/820/002 30 film-coated tablets: EU/1/13/820/003 42 film-coated tablets: EU/1/13/820/004 50 film-coated tablets: EU/1/13/820/005 56 film-coated tablets: EU/1/13/820/006 60 film-coated tablets: EU/1/13/820/007 70 film-coated tablets: EU/1/13/820/008 84 film-coated tablets: EU/1/13/820/009 90 film-coated tablets: EU/1/13/820/010 98 film-coated tablets: EU/1/13/820/011 100 film-coated tablets: EU/1/13/820/012 112 film-coated tablets: EU/1/13/820/013
Slovenian: 14 filmsko obloženih tablet: EU/1/13/820/001 28 filmsko obloženih tablet: EU/1/13/820/002 30 filmsko obloženih tablet: EU/1/13/820/003 42 filmsko obloženih tablet: EU/1/13/820/004 50 filmsko obloženih tablet: EU/1/13/820/005 56 filmsko obloženih tablet: EU/1/13/820/006 60 filmsko obloženih tablet: EU/1/13/820/007 70 filmsko obloženih tablet: EU/1/13/820/008 84 filmsko obloženih tablet: EU/1/13/820/009 90 filmsko obloženih tablet: EU/1/13/820/010 98 filmsko obloženih tablet: EU/1/13/820/011 100 filmsko obloženih tablet: EU/1/13/820/012 112 filmsko obloženih tablet: EU/1/13/820/013
English: One and a half 10 mg tablets
Slovenian: 3. teden ena 10-miligramska tableta in pol
English: In a study using orally administered
Slovenian: V študiji s peroralnim