FrancophonIA/ELRC3.0 huggingface dataset:
English: ● 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, odpoved srca in krvni strdki v venah (tromboza/tromboembolija)
English: You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Slovenian: Zdravilo Memantin ratiopharm skupaj s hrano in pijačo Obvestite svojega zdravnika, če ste pred kratkim spremenili ali če nameravate bistveno spremeniti prehrano (npr. če preidete iz običajne hrane na strogo vegetarijansko prehrano), ali če imate ledvično tubularno acidozo (preveliko količino kislih spojin v krvi zaradi renalne disfunkcije (slabega delovanja ledvic)) ali če ste zboleli zaradi hudega vnetja sečil (strukture po kateri se prenaša seč).
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores <20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Slovenian: Meta-analiza bolnikov z zmerno do hudo Alzheimerjevo boleznijo (skupna ocena KPSS ob vključitvi < 20), ki je zajela 6 študij faze III, kontroliranih s placebom in trajajočih 6 mesecev (vključno s študijami zdravljenja v monoterapiji ter študij bolnikov na stabilnem odmerku inhibitorjev acetilholinesteraze), je pokazala statistično značilen učinek v korist zdravljenja z memantinom na področjih spoznavnih funkcij ter globalnih in funkcionalnih domen.
English: Memantine ratiopharm contains soya lecithin, see section 4.3.
Slovenian: Zdravilo Memantin ratiopharm vsebuje sojin lecitin, glejte poglavje 4.3.
English: If you go into hospital, let your doctor know that you are taking Memantine ratiopharm.
Slovenian: V primeru, da ste sprejeti v bolnišnico, obvestite zdravnika, da jemljete zdravilo Memantin ratiopharm.
English: Furthermore, Memantine ratiopharm has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Slovenian: Prav tako ima lahko zdravilo Memantin ratiopharm blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev, zato je potrebno bolnike opozoriti na posebno previdnost.
English: In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Slovenian: V teh primerih bo vaš zdravnik nadzoroval ledvično delovanje v določenih časovnih presledkih.
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 presnovki N-3,5-dimetil-gludantan, izomerna mešanica 4- in 6-hidroksi-memantina in 1-nitrozo-3,5-dimetil-adamantana.
English: In particular, Memantine ratiopharm may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Slovenian: Posebno v primeru, da skupaj z zdravilom Memantin ratiopharm jemljete naslednja zdravila, se učinki le teh lahko spremenijo in bo morda vaš zdravnik moral prilagoditi odmerek:
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, zdravljenih z memantinom, pokazalo poslabšanje na področju vseh treh domen (21 % proti 11 %, p<0,0001).
English: ● if you have a history of epileptic seizures.
Slovenian: • če ste v preteklosti imeli epileptične napade,
English: The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows:
Slovenian: Priporočeni začetni odmerek je 5 mg na dan, ki se ga po korakih poveča v prvih štirih tednih zdravljenja, dokler se ne doseže priporočenega vzdrževalnega odmerka, kot sledi:
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg once a day) as described above.
Slovenian: Na podlagi kliničnih študij je priporočen odmerek za bolnike nad 65 let starosti 20 mg na dan (20 mg enkrat dnevno), kot je opisano zgoraj.
English: HDPE (high-density polyethylene) bottles with PP (polypropylene) caps Pack sizes of 100 film-coated tablets.
Slovenian: Plastenke iz HDPE (polietilen visoke gostote) s PP (polipropilenskimi) zaporkami Velikosti pakiranja 100 filmsko obloženih tablet.
English: The patient should take two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet per day.
Slovenian: Bolnik mora jemati dve 10 mg filmsko obloženi tableti (20 mg) ali eno 20 mg filmsko obloženo tableto na dan.
English: PVC/PVDC-Aluminium foil blister packs Pack sizes of 28 (7 +7 +7 + 7) film-coated tablets.
Slovenian: Pretisni omoti iz PVC/PVDC-aluminija Velikosti pakiranja 28 (7 +7 +7 +7) filmsko obloženih tablet.
English: The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Slovenian: Priporočeni vzdrževalni odmerek je 20 mg enkrat dnevno, dosežete pa ga na začetku četrtega tedna zdravljenja.
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 prekomernem 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: 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: EXP Shelf life after first opening: 6 months.
Slovenian: EXP Rok uporabnosti po prvem odprtju: 6 mesecev.
English: EU/1/13/836/001 EU/1/13/836/002 EU/1/13/836/003 EU/1/13/836/004 EU/1/13/836/005 EU/1/13/836/006 EU/1/13/836/007 EU/1/13/836/008 EU/1/13/836/009 EU/1/13/836/010 EU/1/13/836/011 EU/1/13/836/012 EU/1/13/836/013 EU/1/13/836/014 EU/1/13/836/015 EU/1/13/836/016 EU/1/13/836/017 EU/1/13/836/018 EU/1/13/836/019 EU/1/13/836/020 EU/1/13/836/021 EU/1/13/836/022
Slovenian: EU/1/13/836/001 EU/1/13/836/002 EU/1/13/836/003 EU/1/13/836/004 EU/1/13/836/005 EU/1/13/836/006 EU/1/13/836/007 EU/1/13/836/008 EU/1/13/836/009 EU/1/13/836/010 EU/1/13/836/011 EU/1/13/836/012 EU/1/13/836/013 EU/1/13/836/014 EU/1/13/836/015 EU/1/13/836/016 EU/1/13/836/017 EU/1/13/836/018 EU/1/13/836/019 EU/1/13/836/020
English: Only limited experience with overdose is available from clinical studies and post-marketing experience.
Slovenian: Iz kliničnih študij in izkušenj iz obdobja trženja zdravila so na voljo le omejene izkušnje s prevelikim odmerjanjem.
English: At the beginning of treatment you will start by using 5 mg once a day.
Slovenian: Na začetku zdravljenja boste uporabljali 5 mg filmsko obložene tablete enkrat dnevno.
English: Memantine ratiopharm contains lactose and soya lecithin This medicine contains lactose.
Slovenian: Zdravilo Memantin ratiopharm vsebuje laktozo in sojin lecitin To zdravilo vsebuje laktozo.
English: ● anticonvulsants (substances used to prevent and relieve seizures)
Slovenian: • antikonvulzivi (zdravila za preprečevanje ali lajšanje epileptičnih krčev)
English: The use of memantine in pregnant women is not recommended.
Slovenian: Uporaba memantina med nosečnostjo ni priporočljiva.
English: This is increased to one tablet once a day (1x 10 mg) in the second week and to one and a half tablets once a day in the third week.
Slovenian: V drugem tednu povišamo odmerek na eno tableto enkrat dnevno (1 x 10 mg) in v tretjem tednu na eno tableto in pol enkrat dnevno.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg film-coated tablets or one 20 mg film-coated tablet once a day) as described above.
Slovenian: Na podlagi kliničnih študij je priporočen odmerek za bolnike nad 65 let starosti 20 mg na dan (dve 10 mg filmsko obloženi tableti enkrat ali ena 20 mg filmsko obložena tableta dnevno), kot je opisano zgoraj.
English: ● In general, taking too much Memantine ratiopharm should not result in any harm to you.
Slovenian: • Na splošno zaužitje večjega odmerka zdravila Memantin ratiopharm ne sme imeti škodljivih posledic.
English: The recommended daily dose is 20 mg once a day.
Slovenian: Priporočeni dnevni odmerek je 20 mg enkrat dnevno.
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: 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 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: Week 4 (day 22-28):
Slovenian: 4. teden (22.-28. dan):
English: For up-titration other tablet strengths are available.
Slovenian: Za zvišanje odmerka so na voljo druge jakosti.
English: 20 mg film-coated tablets
Slovenian: 20 mg filmsko obložene tablete
English: ● If you take a large overdose of Memantine ratiopharm, contact your doctor or get medical advice,
Slovenian: • V primeru, da ste zaužili prevelik odmerek zdravila Memantin ratiopharm, obvestite svojega zdravnika, ker boste morda potrebovali zdravniško obravnavo.
English: Week 3 (day 15-21):
Slovenian: 3. teden (15.-21. dan):
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 masivno zaužitje alkalno delujočih snovi proti želodčni kislini.
English: LIST OF EXCIPIENTS Contains lactose and soya lecithin.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje laktozo in sojin lecitin.
English: Uncommon (affects 1 to 10 users in 1,000):
Slovenian: Občasni (pojavijo se pri 1 do 10 bolnikov od 1.000 bolnikov):
English: Week 1 (day 1-7):
Slovenian: 1. teden (1.-7. dan):
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets once a day
Slovenian: 3. teden ena in pol 10 mg tableta 4. teden in naprej dve 10 mg tableti enkrat dnevno
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Zdravilo Memantin ratiopharm vsebuje laktozo, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
Slovenian: Druga zdravila in zdravilo Memantin ratiopharm Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Slovenian: Zdravilo Memantin ratiopharm deluje na receptorje NMDA in izboljša prenos živčnih signalov in spomin.
English: Also, Memantine ratiopharm may change your reactivity, making driving or operating machinery inappropriate.
Slovenian: Prav tako Memantin ratiopharm lahko vpliva na vašo sposobnost odzivanja, zato se vožnja in upravljanje strojev ne priporoča.
English: If you take more Memantine ratiopharm than you should
Slovenian: Če ste vzeli večji odmerek zdravila Memantin ratiopharm, kot bi smeli
English: Memantine ratiopharm should be administered orally once a day.
Slovenian: Zdravilo Memantin ratiopharm jemljite peroralno enkrat dnevno.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg or 10 mg or 15 mg or 20 mg of memantine hydrochloride equivalent to 4.15 mg or 8.31 mg or 12.46 mg or 16.62 mg memantine.
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg ali 10 mg ali 15 mg ali 20 mg memantinijevega klorida, kar ustreza 4,15 mg ali 8,31 mg ali 12,46 mg ali 16,62 mg memantina.
English: ● neuroleptics (substances used in the treatment of mental disorders)
Slovenian: • nevroleptiki (zdravila za zdravljenje duševnih motenj)
English: PHARMACEUTICAL FORM Film-coated tablet (tablet)
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta)
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: Week 2 (day 8-14):
Slovenian: 2. teden (8.-14. dan):
English: What Memantine ratiopharm is and what it is used for
Slovenian: Kaj je zdravilo Memantin ratiopharm in za kaj ga uporabljamo
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: The maximum daily dose is 20 mg per day.
Slovenian: Največji dnevni odmerek je 20 mg.
English: ● if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na memantinijev klorid, arašide ali sojo ali katero koli sestavino tega zdravila
English: Shelf life after first opening of the container: 6 months
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 6 mesecev
English: Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer's disease.
Slovenian: Za kaj uporabljamo zdravilo Memantin ratiopharm Zdravilo Memantin ratiopharm uporabljamo za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
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: HDPE bottles:
Slovenian: Plastenke HDPE:
English: What you need to know before you take Memantine ratiopharm
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Memantin ratiopharm
English: 10 film-coated tablets 14 film-coated tablets 21 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 14 filmsko obloženih tablet 21 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 42 filmsko obloženih tablet 50 filmsko obloženih tablet 56 filmsko obloženih tablet 98 filmsko obloženih tablet 100 filmsko obloženih tablet 112 filmsko obloženih tablet
English: If you forget to take Memantine ratiopharm
Slovenian: Če ste pozabili vzeti zdravilo Memantin ratiopharm
English: 10 film-coated tablets 14 film-coated tablets 21 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 14 filmsko obloženih tablet 21 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 42 filmsko obloženih tablet 56 filmsko obloženih tablet 98 filmsko obloženih tablet 100 filmsko obloženih tablet
English: Administration of Memantine ratiopharm is not recommended in patients with severe hepatic impairment.
Slovenian: Dajanje zdravila Memantin ratiopharm bolnikom s hudo jetrno okvaro ni priporočeno.
English: Constipation Vomiting Pancreatitis2
Slovenian: Neznana pogostnost zaprtje bruhanje pankreatitis2
English: Outer packaging for 4 week treatment initiation pack (28 tablets, week 1-4)
Slovenian: Zunanja ovojnina za 4-tedensko pakiranje za začetno zdravljenje (28 tablet, 1.-4. teden)
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within
Slovenian: V študiji peroralnega 14C-memantina se je izločilo 84 % odmerka v 20 dneh, več kot 99 % preko ledvic.
English: ● Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders,
Slovenian: • glavobol, zaspanost, zaprtje, zvišane vrednosti testov jetrne funkcije, omotica, motnje ravnotežja, zasoplost, visok krvni tlak in preobčutljivost za zdravilo
English: The recommended dose of Memantine ratiopharm for adults and older patients is 20 mg once a day.
Slovenian: Za odrasle in starejše bolnike je priporočeni odmerek zdravila Memantin ratiopharm 20 mg enkrat dnevno.
English: EU/1/13/836/013 10 film-coated tablets EU/1/13/836/014 14 film-coated tablets EU/1/13/836/015 21 film-coated tablets EU/1/13/836/016 28 film-coated tablets EU/1/13/836/017 30 film-coated tablets EU/1/13/836/018 42 film-coated tablets EU/1/13/836/019 56 film-coated tablets EU/1/13/836/020 98 film-coated tablets EU/1/13/836/021 100 film-coated tablets
Slovenian: EU/1/13/836/013 10 filmsko obloženih tablet EU/1/13/836/014 14 filmsko obloženih tablet EU/1/13/836/015 21 filmsko obloženih tablet EU/1/13/836/016 28 filmsko obloženih tablet EU/1/13/836/017 30 filmsko obloženih tablet EU/1/13/836/018 42 filmsko obloženih tablet EU/1/13/836/019 56 filmsko obloženih tablet EU/1/13/836/020 98 filmsko obloženih tablet EU/1/13/836/021 100 filmsko obloženih tablet
English: Women taking Memantine ratiopharm should not breast-feed.
Slovenian: Ženske, ki jemljejo zdravilo Memantin ratiopharm, ne smejo dojiti.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine ratiopharm reassessed by your doctor on a regular basis.
Slovenian: Vaš zdravnik naj redno ocenjuje klinično korist zdravila Memantin ratiopharm.
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: V temeljni klinični študiji pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3-14 točk na lestvici KPSS ("Kratkem preskusu spoznavnih sposobnosti" oz. MMSE ali "Mini-mental State Examination") ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice CIBIC-plus - ("Clinician's Interview-Based Impression of Change Plus Caregiver Input" oz. "Vtis sprememb na osnovi kliničnega intervjuja"): p=0,025; ADCS-ADLsev ("Alzheimer's Disease Consortium Studies Activities of Daily Living-modified for severe dementia" oz. "Vprašalnik vsakodnevnih aktivnosti): p=0,003; SIB ("Severe Impairment Battery" oz. "Sklop testov za hudo prizadetost"): p=0,002).
English: ● anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
Slovenian: • antiholinergiki (zdravila, ki se na splošno uporabljajo za zdravljenje motenj gibanja in trebušnih krčev)
English: Polysorbate 80 (E 433) Polyvinyl alcohol (E 1203) Titanium dioxide (E 171) Talc (E 553b) Soya lecithin (E 322) Xanthan gum (E 415)
Slovenian: Obloga polisorbat 80 (E 433) polivinilalkohol (E 1203) titanov dioksid (E 171) smukec (E 553b) sojin lecitin (E 322) ksantanski gumi (E 415)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Memantine ratiopharm 10 mg
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Memantin ratiopharm 10 mg
English: Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).
Slovenian: Obloga polisorbat 80 (E 433), polivinilalkohol (E 1203), titanov dioksid (E 171), smukec (E 553b), sojin lecitin (E 322), ksantanski gumi (E 415).
English: EU/1/13/836/001 10 film-coated tablets EU/1/13/836/002 14 film-coated tablets EU/1/13/836/003 21 film-coated tablets EU/1/13/836/004 28 film-coated tablets EU/1/13/836/005 30 film-coated tablets EU/1/13/836/006 42 film-coated tablets EU/1/13/836/007 50 film-coated tablets EU/1/13/836/008 56 film-coated tablets EU/1/13/836/009 98 film-coated tablets EU/1/13/836/010 100 film-coated tablets EU/1/13/836/011 112 film-coated tablets
Slovenian: EU/1/13/836/001 10 filmsko obloženih tablet EU/1/13/836/002 14 filmsko obloženih tablet EU/1/13/836/003 21 filmsko obloženih tablet EU/1/13/836/004 28 filmsko obloženih tablet EU/1/13/836/005 30 filmsko obloženih tablet EU/1/13/836/006 42 filmsko obloženih tablet EU/1/13/836/007 50 filmsko obloženih tablet EU/1/13/836/008 56 filmsko obloženih tablet EU/1/13/836/009 98 filmsko obloženih tablet EU/1/13/836/010 100 filmsko obloženih tablet EU/1/13/836/011 112 filmsko obloženih tablet
English: 15 mg tablet week 4 and beyond 20 mg tablets once a day
Slovenian: 4. teden in naprej 20 mg tablete enkrat dnevno
English: Venous thrombosis/thromboembolism
Slovenian: Pogosti Občasni hipertenzija venska tromboza/tromboembolija
English: Cellulose microcrystalline (E 460) Starch pregelatinised (E 1404) Lactose anhydrous Colloidal anhydrous silica (E 551) Magnesium stearate (E 470b)
Slovenian: Jedro tablete mikrokristalna celuloza (E 460) predgelirani škrob (E 1404) brezvodna laktoza brezvoden koloidni silicijev dioksid (E 551) magnezijev stearat (E 470b)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/023
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/836/023
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: 1. teden (1.-7. dan): Bolnik mora sedem dni jemati polovico 10 mg filmsko obložene tablete (5 mg) na dan. 2. teden (8.-14. dan): Bolnik mora sedem dni jemati eno 10 mg filmsko obloženo tableto (10 mg) na dan. 3. teden (15.-21. dan): Bolnik mora sedem dni jemati eno in pol 10 mg filmsko obloženo tableto (15 mg) na dan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/836/012