natgillin/translations-raw huggingface dataset:
The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Pri bolnikih, ki imajo zmerne ali hude težave z ledvicami, bo treba odmerek zdravila morda zmanjšati.
The safety and effectiveness of Axura have not been established in patients with severe liver problems.
Varnost in učinkovitost zdravila Axura pri bolnikih s hudimi težavami z jetri nista bili dokazani.
The cause of Alzheimer’ s disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain.
Vzrok za Alzheimerjevo bolezen ni znan, vendar se domneva, da izguba spomina pri bolezni nastane zaradi motenj v prenosu signalov v možganih.
Axura works by blocking special types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches.
Zdravilo Axura deluje tako, da zavira posebno vrsto receptorjev, imenovanih receptorji NMDA, na katere se živčni prenašalec glutamat navadno veže.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer’ s disease.
Spremembe načina, kako glutamat prenaša signale v možganih, se povezujejo z izgubo spomina, kakršno opažamo pri Alzheimerjevi bolezni.
In addition, high levels of glutamate in the brain can cause the nerve cells in the brain to become overstimulated, which may result in cell damage or death.
Poleg tega lahko visoke ravni glutamata v možganih povzročijo prekomerno stimulacijo živčnih celic v možganih, kar lahko povzroči poškodbo ali odmiranje celic.
By blocking NMDA receptors, memantine hydrochloride blocks these effects of glutamate, improving the transmission of signals in the brain and reducing the symptoms of Alzheimer’ s disease.
Memantinijev klorid z zaviranjem receptorjev NMDA zavira te učinke glutamata, s tem pa izboljšuje prenos signalov v možganih in zmanjšuje simptome Alzheimerjeve bolezni.
Axura has been studied in three main studies including a total of 1,125 patients with Alzheimer’ s disease, some of whom had taken other medicines for their disease in the past.
Zdravilo Axura so preučevali v treh glavnih študijah s skupno 1125 bolniki z Alzheimerjevo boleznijo, pri čemer so nekateri izmed njih v preteklosti prejemali druga zdravila za zdravljenje te bolezni.
The effects of Axura were compared with those of placebo (a dummy treatment) over 24 to 28 weeks.
Učinke zdravila Axura so primerjali z učinki placeba (zdravilo brez zdravilne učinkovine) v obdobju 24 do 28 tednov.
The main measures of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Glavno merilo učinkovitosti je bila sprememba simptomov na treh glavnih področjih: funkcionalnem (stopnja invalidnosti), kognitivnem (sposobnost mišljenja, učenja in pomnjenja) in globalnem (kombinacija več področij, vključno s splošno funkcijo, kognitivnimi simptomi, vedenjem in sposobnostjo izvajanja vsakodnevnih opravil).
Axura was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Zdravilo Axura so preučevali še v treh dodatnih študijah, ki so vključevale skupno 1186 bolnikov z blago do hudo boleznijo.
Axura was more effective than placebo at controlling the symptoms of Alzheimer’ s disease.
Zdravilo Axura je bilo pri nadzorovanju simptomov Alzheimerjeve bolezni učinkovitejše od placeba.
In the study of moderately severe to severe disease, patients taking Axura had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
V študiji z bolniki z zmerno hudo do hudo boleznijo je bilo po 28 tednih pri bolnikih, ki so jemali zdravilo Axura, manj simptomov kot pri bolnikih, ki so jemali placebo, merjeno na globalnem in funkcionalnem merilu.
In the two studies of mild to moderate disease, patients on Axura had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
V dveh študijah z bolniki z blago do zmerno boleznijo so imeli bolniki, ki so prejemali zdravilo Axura, po 24 tednih manj hudih simptomov, merjeno na podlagi globalnih in kognitivnih meril.
However, when these results were considered along with those of the three additional studies, it was noted that the effect of Axura was smaller in patients with mild disease.
Vendar pa je bilo ob primerjavi teh rezultatov z rezultati treh dodatnih študij ugotovljeno, da je bil učinek zdravila Axura manjši pri bolnikih z blago boleznijo.
The most common side effects with Axura (seen in between 1 and 10 patients in 100) are headache, somnolence (sleepiness), hypertension (high blood pressure), constipation and dizziness.
Najpogostejši neželeni učinki zdravila Axura (opaženi pri 1 do 10 bolnikih izmed 100) so glavobol, somnolenca (zaspanost), hipertenzija (visok krvni tlak), zaprtje in omotica.
For the full list of all side effects reported with Axura, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Axura, glejte navodilo za uporabo.
Axura should not be used in people who may be hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Zdravila Axura ne smejo uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) memantinijev klorid ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Axura’ s benefits are greater than its risks for the treatment of patients with moderate to severe Alzheimer’ s disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Axura pri zdravljenju bolnikov z zmerno do hudo Alzheimerjevo boleznijo večje od z njim povezanih tveganj.
The Committee recommended that Axura be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Axura odobri dovoljenje za promet.
Other information about Axura:
Druge informacije o zdravilu Axura:
The European Commission granted a marketing authorisation valid throughout the European Union to Merz Pharmaceuticals GmbH for Axura on 17 May 2002.
Evropska komisija je dovoljenje za promet z zdravilom Axura, veljavno po vsej Evropski uniji, odobrila družbi Merz Pharmaceuticals GmbH dne 17. maja 2002.
The marketing authorisation was renewed on 17 May 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano 17. maja 2007.
The full EPAR for Axura can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Axura je na voljo tukaj.
Invented name
Izmišljen ime
Packaging
Pot uporabe
Oral use Oral use Oral use
Vsebina Velikost pakiranja
10 mg/ g 10 mg/ g 10 mg/ g 10 mg 10 mg 10 mg 10 mg
10 mg 10 mg 10 mg 10 mg/ g 10 mg/ g 10 mg/ g 10 mg 10 mg 10 mg 10 mg 10 mg/ g 10 mg 10 mg 10 mg 10 mg 5mg+10mg +15mg+20mg
Oral drops solution Oral drops solution Oral drops solution Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Peroralne kapljice, raztopina Peroralne kapljice, raztopina Peroralne kapljice, raztopina Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Peroralne kapljice, raztopina Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete
Oral drops solution Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
bottle (glass) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP)
Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Steklenička Steklenička Steklenička Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Steklenička Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP)
10 bottles 14 tablets 42 tablets 98 tablets 980 (10 x 98) tablets 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
30 tablet 50 tablet 100 tablet 20g 1 steklenička 50g 1 steklenička 100g 1 steklenička 28 tablet 56 tablet 112 tablet 1000 (20 x 50) tablet 50 g 10 stekleničk 14 tablet 42 tablet 98 tablet 980 (10 x 98) tablet 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablet
20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 5mg+10 mg +15mg+20mg
20mg 20mg 20mg 20mg 20mg 20mg 5mg+10mg +15mg+20mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete
Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) blister (alu/ PP) PVDC/ PE/ PVC/ AL
Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) Pretisni omot (Alu/ PP) PVDC/ PE/ PVC/ AL
14 tablets 28 tablets 42 tablets 56 tablets 98 tablets 840 tablets (20 x 42 tablets) 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
14 tablet 28 tablet 42 tablet 56 tablet 98 tablet 840 (20 x 42) tablet 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete Filmsko obložene tablete
Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
14 tablets 28 tablets 42 tablets 56 tablets 98 tablets 840 tablets (20 x 42 tablets)
14 tablet 28 tablet 42 tablet 56 tablet 98 tablet 840 (20 x 42) tablet
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 166 mg lactose, see section 4.4.
Pomožna snov: vsaka filmsko obložena tableta vsebuje 166 mg laktoze, glejte poglavje 4. 4.
White to off-white film-coated tablets, centrally tapered oblong, biconvex, with a single breakline on both sides.
Filmsko obložene tablete Bele do belkaste filmsko obložene tablete, centralno stanjšane, podolgovate, bikonveksne, z enojno zarezo na obeh straneh.
Treatment of patients with moderate to severe Alzheimer’ s disease.
Zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
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.
Dose titration The maximum daily dose is 20 mg per day.
Prilagajanje odmerka Najvišji dnevni odmerek je 20 mg.
Week 1 (day 1-7):
1. teden (1. - 7. dan):
Week 2 (day 8-14):
2. teden (8. - 14. dan):
Week 3 (day 15-21):
3. teden (15. - 21. dan):
The patient should take two 10 mg film-coated tablets (20 mg) per day.
Od 4. tedna dalje Bolnik naj jemlje dve 10 mg filmsko obloženi tableti (20 mg) na dan.
2 Maintenance dose The recommended maintenance dose is 20 mg per day.
2 Vzdrževalni odmerek Priporočeni vzdrževalni odmerek je 20 mg na dan.
Axura 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 Axura pri otrocih pod 18 let ni priporočljiva.
In patients with mildly impaired renal function (creatinine clearance 50 - 80 ml/ min) no dose adjustment is required.
Pri bolnikih z blago okvaro delovanja ledvic (očistek kreatinina 50 – 80 ml/ min) prilagoditev odmerka ni potrebna.
In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/ min) daily dose should be 10 mg per day.
Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30 – 49 ml/ min) naj bo dnevni odmerek 10 mg.
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 na do 20 mg dnevno, po standardni titracijski shemi.
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.
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 N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Sočasni uporabi antagonistov N- metil- D- aspartata (NMDA), kot so amantadin, ketamin ali dekstrometorfan, se je potrebno izogniti.
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 osrednjega živčnega sistema (OŽS) pogostejši in bolj izraženi (glejte tudi poglavje 4. 5).
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.
These factors include drastic changes in diet, e. g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers.
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.
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
V večini kliničnih preskušanj so bili bolniki z nedavnim srčnim infarktom, dekompenziranim kongestivnim srčnim popuščanjem (NYHA III– IV) ali neurejeno hipertenzijo izključeni.
The film-coated tablets contain lactose monohydrate.
Filmsko obložene tablete vsebujejo laktozo monohidrat.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malasorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
• 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
Sočasno dajanje
3 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.
The same may be true for ketamine and dextromethorphan (see also section 4.4).
Podobno velja za ketamin in dekstrometorfan (glejte tudi poglavje 4. 4).
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 součinkovanja memantina z gliburidom/ metforminom ali donepezilom.
Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
V študijah na živalih so ugotovili, da memantin lahko zavira intrauterino rast pri izpostavljenosti, ki je enaka ali le malo višja od izpostavljenosti pri ljudeh (glejte poglavje 5. 3).
Moderate to severe Alzheimer’ s disease usually causes impairment of driving performance and compromises the ability to use machinery.
Zmerna do huda Alzheimerjeva bolezen je običajno sama vzrok za nesposobnost vožnje in upravljanja s stroji.
The most frequently occurring adverse reactions with a higher incidence in the Axura 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 Axura, 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%).
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).
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
4 Cardiac disorders
4 < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Uncommon
Bolezni srca Bolezni živčevja
Cardiac failure
Občasni Pogosti Občasni Zelo redki
Nervous system
Odpoved srca Omotica Neobičajna hoja Epileptični napadi
Gait abnormal
Bolezni prebavil
Gastrointestinal disorders
Pogosti Občasni Neznane pogostnosti
Pancreatitis2
Zaprtje Bruhanje Pankreatitis2
Infections and infestations
Infekcije in parazitske bolezni Žilne bolezni
Fungal infections
Občasni Pogosti Občasni
Vascular disorders
Glivična okužba Hipertenzija Venska tromboza / tromboembolija
Common
1
Venous thrombosis/ thromboembolism
Splošne težave in spremembe na mestu aplikacije Psihiatrične motnje
General disorders and administration site conditions
Pogosti Občasni Pogosti Občasni Občasni Neznane pogostnosti
Psychiatric disorders
Glavobol Utrujenost Zaspanost Zmedenost Halucinacije1 Psihotične reakcije2
1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
Halucinacije so bile večinoma opažene pri bolnikih s hudo Alzheimerjevo boleznijo.
2 Isolated cases reported in post-marketing experience Alzheimer ’ s disease has been associated with depression, suicidal ideation and suicide.
2 Osamljeni primeri, o katerih so poročali v okviru postmarketinških izkušenj.
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 veliko preveliko odmerjanje (200 mg dnevno oziroma 105 mg dnevno, tri dni) je bilo povezano 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 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).
5 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.
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 osrednjega živčnega sistema (OŽS) je treba razmisliti o previdnem simptomatičnem kliničnem zdravljenju.
Other Anti-dementia drugs, ATC code:
Farmakoterapevtska skupina: druga zdravila za zdravljenje demence, oznaka ATC:
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.
Klinične študije 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 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 Vtis sprememb na osnovi kliničnega intervjuja (CIBIC- plus - "Clinician' s Interview- Based Impression of Change Plus Caregiver Input"): p=0, 025; Vprašalnik vsakodnevnih aktivnosti (ADCS- ADLsev oz.