natgillin/translations-raw huggingface dataset:
Ristfor 50 mg/850 mg film-coated tablets
Ristfor 50 mg/850 mg filmsko obložene tablete
Ristfor is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Zdravilo Ristfor je indicirano v kombinaciji s sulfonilsečnino (tj. trojno kombinirano zdravljenje) kot dodatek dieti in telesni aktivnosti pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka metformina, ki ga prenašajo, in sulfonilsečnine.
Ristfor 50 mg/1,000 mg film-coated tablets
Ristfor 50 mg/1.000 mg filmsko obložene tablete
Studies of sitagliptin in combination with metformin In a 24-week, placebo-controlled clinical study to evaluate the efficacy and safety of the addition of sitagliptin 100 mg once daily to ongoing metformin, sitagliptin provided significant improvements in glycaemic parameters compared with placebo.
Študije sitagliptina v kombinaciji z metforminom V 24-tedenski s placebom nadzorovani študiji, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali obstoječemu zdravljenju z metforminom, je sitagliptin pomembno izboljšal glikemične parametre v primerjavi s placebom.
Maximum daily dose is 25 mg.
Največji dnevni odmerek je 25 mg.
No animal studies have been conducted with Ristfor.
Študij na živalih z zdravilom Ristfor niso opravili.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
Pri bolnikih z neustreznim nadzorom pri dvojni kombinaciji z insulinom in največjim odmerkom metformina, ki ga prenašajo
Maximum daily dose is 100 mg.
Največji dnevni odmerek je 100 mg.
Sitagliptin 50 mg + metformin 500 mg (N=183)
Začetno zdravljenje (dvakrat na dan) sitagliptin 50 mg + metformin 500 mg (n = 183)
No treatment related effects on fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Pri samcih in samicah podgan, ki so sitagliptin prejemali pred in med obdobjem parjenja, niso opazili z zdravljenjem povezanih učinkov na plodnost.
In a pre-/post-natal development study performed in rats sitagliptin showed no adverse effects.
Študije, izvedene s sitagliptinom na podganah, niso pokazale neželenih učinkov na pre-/post-natalni razvoj.
- The active substances are sitagliptin and metformin.
- Učinkovini sta sitagliptin in metformin.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a PPAR agonist
Pri bolnikih z neustreznim nadzorom pri dvojni kombinaciji z največjim odmerkom metformina, ki ga prenašajo, in agonistom PPAR
Study of sitagliptin in combination with metformin and a PPAR agonist A 26-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to the combination of pioglitazone and metformin.
Študija sitagliptina v kombinaciji z metforminom in agonistom PPAR Zasnovana je bila 26-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali kombinaciji pioglitazona in metformina.
Study of sitagliptin in combination with metformin and insulin A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Študija sitagliptina v kombinaciji z metforminom in insulinom Zasnovana je bila 24-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali insulinu (vsaj 10 tednov stabilen odmerek) z ali brez metformina (vsaj 1.500 mg).
After an oral dose of metformin, Tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60 % in healthy subjects.
Pri zdravih posameznikih je absolutna biološka uporabnost 500-miligramske tablete metformina približno 50 do 60 %.
Maximum daily dose is 50 mg.
Največji dnevni odmerek je 50 mg.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea
Pri bolnikih z neustreznim nadzorom pri dvojni kombinaciji z največjim odmerkom metformina, ki ga prenašajo, in sulfonilsečnino
No dose adjustment for sitagliptin is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Pri bolnikih z blago ali zmerno jetrno okvaro (ocena po Child-Pugh-u  9) odmerka ni treba prilagoditi.
Do not take Ristfor if any of the above apply to you and talk with your doctor about other ways of managing your diabetes.
Zdravila Ristfor ne jemljite in se z zdravnikom posvetujte o drugih možnostih za nadzor sladkorne bolezni, če kar koli od navedenega velja za vas.
Study of sitagliptin in combination with metformin and a sulphonylurea A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride (alone or in combination with metformin).
Študija sitagliptina v kombinaciji z metforminom in s sulfonilsečnino Zasnovana je bila 24-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali glimepiridu (samemu ali v kombinaciji z metforminom).
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Some patients have experienced the following side effects while taking this medicine in combination with insulin:
Pri nekaterih bolnikih, ki so jemali to zdravilo v kombinaciji z insulinom, so se pojavili naslednji neželeni učinki:
Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin.
Sitagliptin je tudi substrat za p-glikoprotein, ki je prav tako lahko vključen pri izločanju sitagliptina skozi ledvice, vendar pa ciklosporin, zaviralec pglikoproteina, ni zmanjšal ledvičnega očistka sitagliptina.
Sitagliptin 100 mg once daily added to ongoing metformin therapy (N=453)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z metforminom (n = 453)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH
Talk to your doctor or pharmacist before taking Ristfor: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Pred začetkom jemanja zdravila Ristfor se posvetujte z zdravnikom ali farmacevtom: - če imate ali ste kdaj imeli bolezen trebušne slinavke (kot je pankreatitis).
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Ristfor 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Ristfor 50 mg/1.000 mg tablete sitagliptin/metformin HCl
EU/1/10/620/009 14 film-coated tablets EU/1/10/620/010 28 film-coated tablets EU/1/10/620/011 56 film-coated tablets EU/1/10/620/021 60 film-coated tablets EU/1/10/620/012 112 film-coated tablets EU/1/10/620/013 168 film-coated tablets EU/1/10/620/022 180 film-coated tablets EU/1/10/620/014 196 film-coated tablets EU/1/10/620/015 50 x 1 film-coated tablets EU/1/10/620/016 196 (2 x 98) film-coated tablets EU/1/10/620/018 168 (2 x 84) film-coated tablets
EU/1/10/620/009 14 filmsko obloženih tablet EU/1/10/620/010 28 filmsko obloženih tablet EU/1/10/620/011 56 filmsko obloženih tablet EU/1/10/620/021 60 filmsko obloženih tablet EU/1/10/620/012 112 filmsko obloženih tablet EU/1/10/620/013 168 filmsko obloženih tablet EU/1/10/620/022 180 filmsko obloženih tablet EU/1/10/620/014 196 filmsko obloženih tablet EU/1/10/620/015 50 x 1 filmsko obložena tableta EU/1/10/620/016 196 (2 x 98) filmsko obloženih tablet EU/1/10/620/018 168 (2 x 84) filmsko obloženih tablet
No metabolites have been identified in humans.
Presnovkov pri človeku niso ugotovili.
Sitagliptin 100 mg once daily added to ongoing insulin + metformin therapy (N=223)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z insulinom in metforminom (n = 223)
In this study there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
V tej študiji je bila pojavnost hipoglikemije, o kateri so poročali, podobna pri bolnikih, ki so prejemali sitagliptin, in pri bolnikih, ki so prejemali placebo.
Ristfor 50 mg/850 mg tablets sitagliptin/metformin HCl
Ristfor 50 mg/850 mg tablete sitagliptin/metformin HCl
EU/1/10/620/001 14 film-coated tablets EU/1/10/620/002 28 film-coated tablets EU/1/10/620/003 56 film-coated tablets EU/1/10/620/019 60 film-coated tablets EU/1/10/620/004 112 film-coated tablets EU/1/10/620/005 168 film-coated tablets EU/1/10/620/020 180 film-coated tablets EU/1/10/620/006 196 film-coated tablets EU/1/10/620/007 50 x 1 film-coated tablets EU/1/10/620/008 196 (2 x 98) film-coated tablets EU/1/10/620/017 168 (2 x 84) film-coated tablets
EU/1/10/620/001 14 filmsko obloženih tablet EU/1/10/620/002 28 filmsko obloženih tablet EU/1/10/620/003 56 filmsko obloženih tablet EU/1/10/620/019 60 filmsko obloženih tablet EU/1/10/620/004 112 filmsko obloženih tablet EU/1/10/620/005 168 filmsko obloženih tablet EU/1/10/620/020 180 filmsko obloženih tablet EU/1/10/620/006 196 filmsko obloženih tablet EU/1/10/620/007 50 x 1 filmsko obložena tableta EU/1/10/620/008 196 (2 x 98) filmsko obloženih tablet EU/1/10/620/017 168 (2 x 84) filmsko obloženih tablet
depending on how your kidneys are working - if you have recently had a heart attack or have severe circulatory problems, such as ‘shock' or breathing difficulties - if you have liver problems - if you drink alcohol to excess (either every day or only from time to time) - if you are breast-feeding.
- če ste pred nedavnim imeli srčni napad ali imate hude težave s krvnim obtokom, kot so "šok" ali težave pri dihanju.
Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z glimepiridom in metforminom (n = 115)
What Ristfor contains
Kaj vsebuje zdravilo Ristfor
Paediatric No studies with sitagliptin have been performed in paediatric patients.
Otroci Pri otrocih študij s sitagliptinom niso izvedli.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Ristfor.
Če niste prepričani, se pred začetkom jemanja zdravila Ristfor, posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju s pioglitazonom in metforminom (n = 152)
Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache or vomiting when starting the combination of sitagliptin and metformin together (frequency is common).
Po začetku zdravljenja s kombinacijo sitagliptina in metformina so se pri nekaterih bolnikih pojavili driska, siljenje na bruhanje, napenjanje, zaprtje, bolečine v trebuhu ali bruhanje (pojavijo se pogosto).
Do not take Ristfor: - if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6) - if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
- če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
If pancreatitis is suspected, Ristfor and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Ristfor should not be restarted.
V primeru potrjenega akutnega pankreatitisa se zdravila Ristfor ne sme ponovno uvesti.
The incidence of hypoglycaemia was also similar in patients treated with sitagliptin or placebo.
Tudi pojavnost hipoglikemije je bila pri bolnikih, ki so prejemali sitagliptin in tistih, ki so prejemali placebo, podobna.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
Ena filmsko obložena tableta (tableta) vsebuje sitagliptinijev fosfat monohidrat, ki ustreza 50 mg sitagliptina, in 850 mg metforminijevega klorida.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
Ena filmsko obložena tableta (tableta) vsebuje sitagliptinijev fosfat monohidrat, ki ustreza 50 mg sitagliptina, in 1.000 mg metforminijevega klorida.
In addition, patients should be alerted to the risk of hypoglycaemia when Ristfor is used in combination with a sulphonylurea or with insulin.
Poleg tega je treba bolnike, ki jemljejo zdravilo Ristfor skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
Ristfor 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Ristfor 50 mg/850 mg filmsko obložene tablete sitagliptin/metforminijev klorid
This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Ristfor (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Ristfor, as you may experience low blood sugar levels (hypoglycaemia).
- če imate ali ste imeli alergijsko reakcijo na sitagliptin, metformin ali zdravilo Ristfor (glejte poglavje 4).
Ristfor 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Ristfor 50 mg/1.000 mg filmsko obložene tablete sitagliptin/metforminijev klorid
Some patients taking metformin have experienced the following side effects after starting sitagliptin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): nizek krvni sladkor, siljenje na bruhanje, napenjanje, bruhanje
How to store Ristfor
Kako jemati zdravilo Ristfor
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
Ena tableta vsebuje sitagliptinijev fosfat monohidrat, ki ustreza 50 mg sitagliptina, in 850 mg metforminijevega klorida.
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
Ena tableta vsebuje sitagliptinijev fosfat monohidrat, ki ustreza 50 mg sitagliptina, in 1.000 mg metforminijevega klorida.
Uncommon nausea
Ledvična okvara
Ristfor combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Vsebuje sitagliptinijev fosfat, ki je zaviralec dipeptidil-peptidaze 4 (DPP-4), in metforminijev klorid, ki spada med bigvanide.
Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Ristfor) or during post-approval use of Ristfor or sitagliptin alone or with other diabetes medicines:
Pri nekaterih bolnikih, ki so v kliničnih študijah jemali samo sitagliptin (eno od učinkovin v zdravilu Ristfor) ali so v obdobju trženja jemali zdravilo Ristfor ali sitagliptin, sam ali z drugimi zdravili za zdravljenje sladkorne bolezni, so se pojavili naslednji neželeni učinki: Pogosti: nizek krvni sladkor, glavobol, okužba zgornjih dihal, zamašen nos ali izcedek iz nosu in vnetje grla, osteoartritis, bolečine v rokah ali nogah Občasni: omotica, zaprtje, srbenje
Body weight did not increase from baseline with sitagliptin therapy.
faze starost ni imela kliničnega pomena za farmakokinetiko sitagliptina.
If bullous pemphigoid is suspected, Ristfor should be discontinued.
Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Ristfor prekiniti.
Mean change from baseline HbA1c (%)
Povprečna sprememba vrednosti HbA1c od izhodišča
Frequency not known exfoliative skin conditions including Stevens-Johnson syndrome
Bolezni kože in podkožja pruritus občasni angioedem neznana pogostnost izpuščaj neznana pogostnost urtikarija neznana pogostnost kožni vaskulitis neznana pogostnost eksfoliativna stanja na koži, vključno s Stevens-Johnsonovim sindromom neznana pogostnost bulozni pemfigoid neznana pogostnost
tmax is between 3 and 8 hours.
tmax je med 3 in 8 urami.
The volume of distribution is around 10 l/kg.
Volumen porazdelitve je okoli 10 l/kg.
Diagnosis should be made according to current guidelines.
Diagnozo je potrebno postaviti v skladu z veljavnimi smernicami.
In another case of a large overdose, the patient also survived and recovered.
V nekem drugem primeru velikega prevelikega odmerka je bolnik prav tako preživel in okreval.
Week 1, 2, 3, 4 Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28
Teden 1, 2, 3, 4 Dan 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28
Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Zaradi nekaterih dejavnikov, ki lahko povišajo pH urina (glejte poglavje 5.2 »Izločanje«) je potreben skrben nadzor bolnika.
2 Isolated cases reported in post-marketing experience.
2 Osamljeni primeri, o katerih so poročali v okviru postmarketinških izkušenj.
Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur:
Glede na farmakološke učinke in mehanizem delovanja memantina se lahko pojavijo naslednje interakcije:
1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
1 Halucinacije so bile večinoma opažene pri bolnikih s hudo Alzheimerjevo boleznijo.
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Vaš zdravnik vam bo povedal, če zaradi vaše bolezni lahko varno vozite in varno upravljate s stroji.
The effects of barbiturates and neuroleptics may be reduced.
Učinki barbituratov in nevroleptikov so lahko zmanjšani.
You may experience increased symptoms as described in section 4.
Morda boste občutili bolj izražene znake, ki so opisani v poglavju 4.
Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain.
Izguba spomina pri Alzheimerjevi bolezni nastane zaradi motenj v prenosu signalov v možganih.
The patient received symptomatic treatment and plasmapheresis.
Bolnik je bil deležen simptomatičnega zdravljenja in plazmafereze.
Psychotic reactions2
Psihotične reakcije2
Memantine has an absolute bioavailability of approximately 100%.
Memantin ima absolutno biološko uporabnost okoli 100 %.
The clinical relevance of these findings is unknown.
Klinična pomembnost teh pojavov ni poznana.
About 45% of memantine is bound to plasma-proteins.
Okoli 45 % memantina se veže na plazemske beljakovine.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Zdravljenje naj prične in nadzoruje zdravnik, ki ima izkušnje z diagnozo in zdravljenjem Alzheimerjeve demence.
There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
Možna je povezava med tem kopičenjem in nastankom vakuol v pljučih.
Component of a multipack, can't be sold separately.
Sestavni del večkratnega pakiranja se ne sme prodajati ločeno.
Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours.
Memantin se izloča na monoekspotencialni način s končnim razpolovnim časom (t½) 60 do 100 ur.
No specific antidote for intoxication or overdose is available.
Antidota za zastrupitev ali preveliko odmerjanje ni na voljo.
For detailed instructions on the preparation and handling of the product see section 6.6.
Za podrobna navodila o pripravi in ravnanju s produktom glejte poglavje 6.6.
The treatment scheme is also indicated on the treatment initiation pack.
Shema zdravljenja je prikazana tudi na ovojnini za začetek zdravljenja.
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Vse več je dokazov, da motnje v delovanju glutamatnega živčnega prenosa, še posebej preko receptorjev NMDA, prispevajo tako k izraženosti simptomov kot napredovanju bolezni pri nevrodegenerativni demenci.
Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
O prekinitvi zdravljenja z memantinom je treba razmisliti, ko ni več dokazov o zdravilnem učinku ali če bolnik zdravljenja ne prenaša.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V razvrstitvah pogostosti so neželeni učinki navedeni po padajoči resnosti.
Memantine should not be used during pregnancy unless clearly necessary.
Memantina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Alzheimerjeva bolezen je povezana z depresijo, samomorilnimi mislimi in samomorom.
Pharmacotherapeutic group: Other Anti-dementia drugs, ATC code: N06DX01.
Farmakoterapevtska skupina: druga zdravila za zdravljenje demence, oznaka ATC: N06DX01.
It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
Modulira učinke patološko zvišanih toničnih vrednosti glutamata, ki lahko vodijo v nevronsko disfunkcijo.
Once opened, the contents of the bottle should be used within 3 months.
Po odprtju je potrebno vsebino stekleničke porabiti v 3 mesecih.
Balance disorder
Motnje ravnotežja
Instruction for proper use of the pump
Navodilo za pravilno uporabo črpalke
There is no indication that food influences the absorption of memantine.
Kot kaže, hrana ne vpliva na absorpcijo memantina.
Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Previdnost se priporoča pri bolnikih z epilepsijo, s krči v anamnezi ali pri bolnikih z dejavniki nagnjenosti k epilepsiji.
Push down the dosing pump head in a firm but calm and steady manner - not too slowly (fig. 7, fig. 8).
Odmerno črpalko pritiskajte navzdol odločno, a mirno in enekomerno - ne prepočasi (sl. 7, sl. 8).
The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment.
Prenašanje in odmerjanje memantina je treba redno ocenjevati, najbolje v prvih treh mesecih po začetku zdravljenja.
In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
V prospektivno opredeljeni primarni analizi ni bilo statistično značilnih razlik pri primarnih ciljih študije v 24. tednu.
Tabulated list of adverse reactions
Tabeliran seznam neželenih reakcij
This medicinal product does not require any special storage conditions.
Za shranjevanje zdravila niso potrebni posebni pogoji.
This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.
Ta odmerek boste povečevali vsak teden za 5 mg, dokler ne boste dosegli priporočenega (vzdrževalnega) odmerka.
Hallucinations1
Halucinacije1