natgillin/translations-raw huggingface dataset:
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two tablets once a day) as described above.
Na podlagi kliničnih študij je priporočen odmerek za bolnike nad 65 let starosti 20 mg na dan (dve tableti enkrat dnevno), kot je opisano zgoraj.
Ebixa is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Ebixa pri otrocih pod 18 let ni priporočljiva.
If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/ day according to standard titration scheme.
Če bolnik zdravljenje dobro prenaša, se lahko odmerek po najmanj 7 dneh zdravljenja zviša do 20 mg dnevno, po standardni titracijski shemi.
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.
Pri bolnikih z blago ali zmerno jetrno okvaro (Child- Pugh A in Child- Pugh B) prilagoditev odmerjanja ni potrebna.
These compounds act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
Te snovi delujejo na isti receptorski sistem kot memantin, zato so lahko neželeni učinki (zlasti s strani centralnega živčnega sistema (CŽS)) pogostejši in bolj izraženi (glejte tudi poglavje 4. 5).
3 • The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
• Na podlagi mehanizma delovanja se pričakuje, da se učinki L- dope, dopaminergičnih agonistov in antiholinergikov lahko okrepijo ob sočasnem zdravljenju z antagonisti NMDA kot je memantin.
Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary. • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
3 memantina in spazmolitikov, dantrolena ali baklofena lahko spremeni njihove učinke, zato je morda potrebno prilagoditi odmerke. • Sočasni uporabi memantina in amantadina se je potrebno izogniti, ker lahko pride do pojava farmakotoksične psihoze.
There is one published case report on a possible risk also for the combination of memantine and phenytoin. • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels. • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. • In post marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Na voljo je tudi objavljen klinični primer o morebitnem tveganju sočasne uporabe memantina in fenitoina. • Ostale zdravilne učinkovine, kot cimetidin, ranitidin, prokainamid, kinidin, kinin in nikotin, ki uporabljajo isti ledvični kationski transportni sistem kot amantadin, prav tako lahko interagirajo z memantinom, kar vodi v možnost zvišane plazemske vrednosti. • Obstaja možnost zmanjšane serumske koncentracije hidroklorotiazida (HCT) ob sočasni uporabi memantina in HCT oziroma kakršnikoli kombinaciji s HCT. • V okviru postmarketinških izkušenj so poročali o osamljenih primerih povečanja mednarodno umerjenega razmerja (INR) pri bolnikih, ki so bili sočasno zdravljeni z varfarinom.
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.
V raziskavah farmakokinetike (PK) posameznega odmerka pri mladih zdravih osebah ni bilo opaziti interakcij zdravilna učinkovina- zdravilna učinkovina memantina z gliburidom/ metforminom ali donepezilom.
In a clinical study in young healthy subjects no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
V klinični raziskavi pri mladih zdravih posameznikih ni bilo opaziti pomembnega vpliva memantina na farmakokinetiko galantamina.
Furthermore, Ebixa has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Prav tako lahko zdravilo Ebixa ima majhen ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji, zato je potrebno bolnike opozoriti na posebno previdnost.
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse events were usually mild to moderate in severity.
V kliničnih preskušanjih bolnikov z zmerno do hudo demenco, ki so zajeli 1784 bolnikov, zdravljenih z zdravilom Ebixa in 1595 bolnikov, ki so prejemali placebo, se skupna incidenca neželenih reakcij pri zdravilu Ebixa ni razlikovala od placeba, neželeni učinki pa so bili po resnosti večinoma blagi do zmerni.
The most frequently occurring adverse events with a higher incidence in the Ebixa group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
Najpogostejši neželeni učinki, ki so se pogosteje pojavili pri skupini bolnikov, ki je jemala zdravilo Ebixa, kot pri skupini, ki je prejemala placebo, so bili omotica (6, 3% proti 5, 6%), glavobol (5, 2% proti 3, 9%), zaprtje (4, 6% proti 2, 6%), zaspanost (3, 4% proti 2, 2%) in hipertenzija (4, 1% proti 2, 8%).
4 Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
4 Neželeni učinki so razporejeni glede na organske sisteme ob uporabi naslednjih navedb: zelo pogosti (≥1/ 10); pogosti (≥1/ 100 do < 1/ 10); občasni (≥1/ 1. 000 do < 1/ 100); redki (≥1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Cardiac disorders Nervous system disorders
Srčne bolezni Bolezni živčevja
Uncommon Common Uncommon Very rare
Občasni Pogosti Občasni Zelo redki
Cardiac failure Dizziness Gait abnormal Seizures
Odpoved srca Omotica Neobičajna hoja Epileptični napadi
Common Uncommon Not known
Pogosti Občasni Neznane pogostnosti
Constipation Vomiting Pancreatitis2
Zaprtje Bruhanje Pankreatitis2
Infections and infestations Vascular disorders
Infekcije in parazitske bolezni Žilne bolezni
Common Uncommon
Občasni Pogosti Občasni
Fungal infections Hypertension Venous thrombosis/ thromboembolism
Glivična okužba Hipertenzija Venska tromboza / tromboembolija
Psychiatric disorders 1
1
Common Uncommon Uncommon Not known
Pogosti Občasni Pogosti Občasni Občasni Neznane pogostnosti
Somnolence Confusion Hallucinations1 Psychotic reactions2
Glavobol Utrujenost Zaspanost Zmedenost Halucinacije1 Psihotične reakcije2
Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
Halucinacije so bile večinoma opažene pri bolnikih s hudo Alzheimerjevo boleznijo.
Alzheimer’ s disease has been associated with depression, suicidal ideation and suicide.
Alzeheimerjeva bolezen je povezana z depresijo, samomorilnimi mislimi in samomorom.
In post- marketing experience these events have been reported in patients treated with Ebixa.
V okviru postmarketinških izkušenj so te dogodke navajali pri bolnikih, zdravljenih z zdravilom Ebixa.
Relative large overdoses (200 mg and 105 mg/ day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/ or diarrhoea or no symptoms.
Sorazmerno veliki preveliki odmerki (200 mg dnevno oziroma 105 mg dnevno, tri dni) so bili povezani bodisi samo s simptomi utrujenosti, šibkosti in/ ali driske bodisi je bilo brez simptomov.
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)
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, agresivnosti, halucinacije in motnje hoje) in/ ali prebavili (bruhanje in driska).
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.
Pri odstranjevanju zdravilne učinkovine uporabljamo ustrezne standardne klinične postopke, kot so izpiranje želodca, medicinsko oglje (preprečevanje možne entero - hepatične recirkulacije), acidifikacija urina, prisilna diureza.
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
5 Pri znakih in simptomih splošne prekomerne stimulacije centralnega živčnega sistema (CŽS) je treba razmisliti o previdnem simptomatičnem kliničnem zdravljenju.
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.
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.
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).
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.
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
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)).
6 Elimination:
Izločanje:
Blister packs containing either 7, 10, 14 or 20 tablets per blister strip.
Pretisni omoti, ki vsebujejo ali 7, 10, 14 ali 20 tablet v posameznem omotu.
Pack sizes of 14, 28, 30, 42, 49 x 1, 50, 56, 56 x 1, 70, 84, 98, 98 x 1, 100, 100 x 1, 112, 980 (10 x 98) or 1000 (20 x 50) tablets are presented.
V škatli je po 14, 28, 30, 42, 49 x 1, 50, 56, 56 x 1, 70, 84, 98, 98 x 1, 100, 100 x 1, 112, 980 (10 x 98) ali 1000 (20 x 50) tablet.
The pack sizes 49 x 1, 56 x1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
V škatlah po 49 x 1, 56 x 1, 98 x 1 in 100 x 1 filmsko obloženo tableto se tablete nahajajo v pretisnem omotu za enkratni odmerek.
Lundbeck A/ S Ottiliavej 9, DK-2500 Valby Denmark
Lundbeck A/ S Ottiliavej 9, DK- 2500 Valby Danska
15/ 05/ 2002 Date of latest renewal:
8 Datum prve pridobitve dovoljenja: 15/ 05/ 2002 Datum zadnjega podaljšanja dovoljenja:
8 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Ebixa 10 mg/ g oral drops, solution.
Ebixa 10 mg/ g peroralne kapljice, raztopina
1 g of solution contains 10 mg of memantine hydrochloride (equivalent to 8.31 mg memantine).
1 gram raztopine vsebuje 10 mg memantinijevega klorida (kar ustreza 8, 31 mg memantina).
One drop of solution is equivalent to 0,5 mg memantine hydrochloride.
Ena kapljica raztopine ustreza 0, 5 mg memantinijevega hidroklorida.
1 g of solution contains 100 mg of sorbitol E420 and 0.5 mg potassium, see section 4.4.
1 g raztopine vsebuje 100 mg sorbitola E420 in 0, 5 mg kalija, glejte poglavje 4. 4.
The patient should take 10 drops (5 mg) per day for 7 days.
Bolnik mora sedem dni jemati 10 kapljic (5 mg) na dan.
The patient should take 20 drops (10 mg) per day for 7 days.
Bolnik mora sedem dni jemati 20 kapljic (10 mg) na dan.
The patient should take 30 drops (15 mg) per day for 7 days.
Bolnik mora sedem dni jemati 30 kapljic (15 mg) na dan.
The patient should take 40 drops (20 mg) once a day.
Bolnik mora jemati 40 kapljic (20 mg) na dan.
10 Maintenance dose
Vzdrževalni odmerek
The recommended maintenance dose is 20 mg per day.
10 Priporočeni vzdrževalni odmerek je 20 mg na dan.
On the basis of the clinical studies the recommended dose for patients over the age of 65 years is 20 mg per day (40 drops once a day) as described above.
Na podlagi kliničnih študij je priporočen odmerek za bolnike nad 65 let starosti 20 mg na dan (40 kapljic enkrat dnevno), kot je opisano zgoraj.
If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/ day according to standard titration scheme.
Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30 – 49 ml/ min) naj bo dnevni odmerek 10 mg. Če bolnik zdravljenje dobro prenaša, se lahko odmerek po najmanj 7 dneh zdravljenja zviša do 20 mg dnevno, po standardni titracijski shemi.
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.
Pri bolnikih z blago ali zmerno jetrno okvaro (Child- Pugh A in Child- pugh B) prilagoditev odmerka ni potrebna.
Concomitant use of other N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Sočasni uporabi drugih antagonistov N- metil- D- aspartata (NMDA), kot so amantadin, ketamin ali dekstrometorfan se je potrebno izogniti.
There is one published case report on a possible risk also for the combination of memantine and phenytoin. • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels. • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. • In post marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Na voljo je tudi objavljen klinični primer o morebitnem tveganju sočasne uporabe memantina in fenitoina. • Ostale zdravilne učinkovine, kot cimetidin, ranitidin, prokainamid, kinidin, kinin in nikotin, ki uporabljajo isti ledvični kationski transportni sistem kot amantadin, prav tako lahko interagirajo z memantinom, kar vodi v možnost zvišane plazemske vrednosti. • Obstaja možnost zmanjšane serumske koncentracije hidroklorotiazida (HCT) ob sočasni uporabi memantina in HCT, oziroma zdravil, ki vsebujejo HCT. • V okviru postmarketinških izkušenj so poročali o osamljenih primerih povečanja mednarodnega umerjenega razmerja (INR) pri bolnikih, ki so bili sočasno zdravljeni z varfarinom.
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.
V raziskavah farmakokinetike (PK) posameznega odmerka pri mladih zdravih osebah ni bilo opaziti interakcij memantina z gliburidom/ metforminom ali donepezilom.
Furthermore, Ebixa has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Prav tako lahko zdravilo Ebixa ima majhen ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji, zato je potrebno bolnike opozoriti na posebno previdnost.
12 Cardiac disorders Nervous system disorders
Neželeni učinki so razporejeni glede na organske sisteme, ob uporabi naslednjih navedb: zelo pogosti (≥1/ 10); pogosti (≥1/ 100 do < 1/ 10); občasni (≥1/ 1. 000 do < 1/ 100); redki (≥1/ 10. 000 do
Uncommon Common Uncommon Very rare
12 < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Cardiac failure Dizziness Gait abnormal Seizures
Srčne bolezni Bolezni živčevja
Common Uncommon Not known
Občasni Pogosti Občasni Zelo redki
Constipation Vomiting Pancreatitis2
Odpoved srca Omotica Neobičajna hoja Napadi s krči
Infections and infestations Vascular disorders
Bolezni prebavil
Common Uncommon
Pogosti Občasni Neznane pogostnosti
Fungal infections Hypertension Venous thrombosis/ thromboembolism
Zaprtje Bruhanje Pankreatitis2
General disorders and administration site conditions
Infekcije in parazitske bolezni Žilne bolezni
Uncommon
Občasni Pogosti Občasni
Fatigue
Glivična okužba Hipertenzija Venska tromboza / tromboembolija
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).
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).
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.
V temeljni klinični študiji pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3– 14 točk na lestvici Kratkega preskusa spoznavnih sposobnosti (KPSS oz.
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinican´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of the daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
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.
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
Lestvica za ocenjevanje Alzheimerjeve bolezni (ADAS- cog) (p=0, 003) in CIBIC- plus (p=0, 004) po 24 tednih (LOCF).
14 Elimination:
Izločanje:
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.
V primeru alkalnega urina lahko pride do zmanjšane hitrosti izločanja memantina za faktor 7 do 9 (glejte poglavje 4. 4). Alkalizacija urina lahko nastopi po izraziti spremembi v prehrani, npr. prehod z običajne na vegetarijansko ali v primeru masivnega zaužitja alkalnih učinkovin za uravnavanje želodčne kisline.
15/ 05/ 2002 Date of latest renewal:
15/ 05/ 2002 Datum zadnjega podaljšanja dovoljenja:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobni podatki o tem zdravilu so na voljo na strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
Ebixa 20 mg film-coated tablets.
Ebixa 5 mg filmsko obložene tablete Ebixa 10 mg filmsko obložene tablete Ebixa 15 mg filmsko obložene tablete Ebixa 20 mg filmsko obložene tablete
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Vsaka filmsko obložena tableta vsebuje 5 mg memantinijevega klorida (kar ustreza 4, 15 mg memantina).
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Vsaka filmsko obložena tableta vsebuje 10 mg memantinijevega klorida (kar ustreza 8, 31 mg memantina).
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Vsaka filmsko obložena tableta vsebuje 15 mg memantinijevega klorida (kar ustreza 12, 46 mg memantina).
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Vsaka filmsko obložena tableta vsebuje 20 mg memantinijevega klorida (kar ustreza 16, 62 mg memantina).
The 10 mg film-coated tablet contains 166 mg lactose, see section 4.4.
10 mg filmsko obložena tableta vsebuje 166 mg laktoze, glejte poglavje 4. 4.
The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘ 5 ’ on one side and imprint ‘ MEM’ on the other side.
5 mg filmsko obložene tablete so bele do belkaste, ovalno podolgovate, z vtisnjeno številko "5" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
The 10 mg film-coated tablets are white to off-white film-coated tablets, centrally tapered oblong, biconvex, with a single breakline on both sides.
10 mg filmsko obložene tablete so bele do belkaste obložene tablete, centralno stanjšane, podolgovate, bikonveksne, z enojno zarezo na obeh straneh.
The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint ‘ 15 ’ on one side and imprint ‘ MEM’ on the other side.
15 mg filmsko obložene tablete so oranžne do sivo oranžne, ovalno podolgovate, z vtisnjeno številko "15" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
The 20 mg film-coated tablets are pale red to grey-red, oval-oblong film-coated tablets with imprint ‘ 20 ’ on one side and imprint ‘ MEM’ on the other side.
20 mg filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalno podolgovate, z vtisnjeno številko "20" na eni strani in vtisnjeno besedo "MEM" na drugi strani.
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:
17 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:
17 Week 1 (day 1-7):
1. teden (1. - 7. dan):
The patient should take one 10 mg film-coated tablet per day (white to off-white, centrally tapered oblong, biconvex, with a single breakline on both sides) for 7 days.
Bolnik naj 7 dni jemlje eno 10 mg filmsko obloženo tableto na dan (bela do belkasta, centralno stanjšana, podolgovata, bikonveksna, z enojno zarezo na obeh straneh).
The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong film) for 7 days.
Bolnik naj 7 dni jemlje eno 15 mg filmsko obloženo tableto na dan (sivo oranžna, ovalno podolgovata).
The patient should take one 20 mg film-coated tablet per day (grey-red, oval-oblong film) for 7 days.
Bolnik naj 7 dni jemlje eno 20 mg filmsko obloženo tableto na dan (sivo rdeča, ovalno podolgovata).
In patients with severe renal impairment (creatinine clearance 5 – 29 ml/ min) daily dose should be 10 mg per day.
Pri bolnikih s hudo okvaro delovanja ledvic (očistek kreatinina 5 – 29 ml/ min) naj bo dnevni odmerek 10 mg na dan.
These factors include drastic changes in diet, e. g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers.
18 prehod z običajne na vegetarijansko prehrano ali masivno zaužitje alkalno delujočih snovi proti želodčni kislini.