FrancophonIA/ELRC3.0 huggingface dataset:
English: The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market.
Bulgarian: V spodnji preglednici so navedeni podatki o neželenih učinkih zdravila, zbrani v kliničnih študijah z memantinom in od začetka trženja dalje.
English: It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs.
Bulgarian: se memantin izloča v materino mleko, vendar bi iz njegove lipofilnosti lahko sklepali, da se.
English: Very Rare (may affect up to 1 in 10,000 people): • Seizures
Bulgarian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Bulgarian: so na voljo na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu
English: System organ class
Bulgarian: Organski sistem
English: Also, Memantine LEK may change your reactivity, making driving or operating machinery inappropriate.
Bulgarian: Prav tako Memantin LEK lahko vpliva na vašo sposobnost odzivanja, zato se vožnja in upravljanje strojev ne priporoča.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki= inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Bulgarian: s ki vrednostjo (ki = konstanta inhibicije) memantina, ki je 0,5 µmol v frontalnem korteksu pri človeku.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day as described above.
Bulgarian: Na podlagi kliničnih študij je priporočen odmerek za bolnike, starejše od 65 let, 20 mg na dan (dve
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Bulgarian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Memantine LEK 20 mg film-coated tablets are presented as pale red, oval film-coated tablet scored in one side.
Bulgarian: Memantin LEK 20 mg filmsko obložene tablete so bledo rdeče, ovalne, filmsko obložene tablete z razdelilno zarezo na eni strani.
English: Marketing Authorisation Holder Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greece
Bulgarian: Imetnik dovoljenja za promet z zdravilom Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Grčija
English: PHARMACEUTICAL PARTICULARS
Bulgarian: FARMAKOLOŠKE LASTNOSTI
English: Always take this medicine exactly as your doctor has told you.
Bulgarian: tega zdravila natančno upoštevajte navodila zdravnika.
English: Fungal infections
Bulgarian: Žilne bolezni
English: Pale red, oval film-coated tablet scored in one side.
Bulgarian: Bledo rdeče, ovalne filmsko obložene tablete z razdelilno zarezo na eni strani.
English: Women taking Memantine LEK should not breast-feed.
Bulgarian: Ženske, ki jemljejo zdravilo Memantin LEK, ne smejo dojiti.
English: Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
Bulgarian: Alkalizacija urina lahko nastopi po izraziti spremembi v prehrani, npr. prehod z običajne na vegetarijansko, ali pri čezmernem zaužitju alkalnih učinkovin za uravnavanje želodčne kisline.
English: Only limited experience with overdose is available from clinical studies and post-marketing experience.
Bulgarian: iz obdobja trženja zdravila so na voljo le omejene izkušnje
English: Women taking memantine should not breast-feed.
Bulgarian: Ženske, ki prejemajo memantin, naj ne dojijo.
English: No cytochrome P 450 catalysed metabolism has been detected in vitro.
Bulgarian: In vitro niso zaznali presnove preko citokroma P 450.
English: In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Bulgarian: srčnim popuščanjem (NYHA III-IV) ali neurejeno hipertenzijo izključeni.
English: Treatment of adult patients with moderate to severe Alzheimer's disease.
Bulgarian: 4.1 Terapevtske indikacije Zdravljenje odraslih bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
English: If you take more Memantine LEK than you should - In general, taking too much Memantine LEK should not result in any harm to you.
Bulgarian: Če ste vzeli večji odmerek zdravila Memantin LEK, kot bi smeli - Na splošno zaužitje večjega odmerka zdravila Memantin LEK ne bi smelo imeti škodljivih posledic. Morda boste občutili bolj izražene znake, ki so opisani v poglavju 4.
English: These active substances 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).
Bulgarian: Sočasni uporabi antagonistov N-metil-D-aspartata (NMDA), kot so amantadin, ketamin ali dekstrometorfan, se je potrebno izogniti. Te učinkovine delujejo na isti receptorski sistem kot memantin, zato so lahko neželeni učinki (zlasti na centralni živčni sistem (CŽS)) pogostejši in bolj izraženi (glejte tudi poglavje 4.5).
English: No genotoxicity has been observed following testing of memantine in standard assays.
Bulgarian: V standardnih poskusih niso opazili genotoksičnosti.
English: Tel.: +30 210 66 65 067 Email: info@pharmathen.com
Bulgarian: Tel.: +30 210 66 65 067 E-pošta:
English: • 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.
Bulgarian: Na podlagi mehanizma delovanja se pričakuje, da se ob sočasnem zdravljenju z antagonisti NMDA kot je memantin, učinki L-dope, dopaminergičnih agonistov in antiholinergikov, lahko okrepijo.
English: Memantine LEK 10 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 50, 56, 60, 98, 100 and 112 tablets.
Bulgarian: Memantin LEK 10 mg filmsko obložene tablete so na voljo v pretisnih omotih iz PVC / PVDCaluminija s 28, 30, 42, 50, 56, 60, 98, 100 in 112 tablet.
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 mL/min) daily dose should be 10 mg per day.
Bulgarian: Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30 - 49 ml/min) naj bo dnevni odmerek 10 mg.
English: Hepatic impairment
Bulgarian: Neznana hepatitis
English: PC:
Bulgarian: Izdelovalec:
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Bulgarian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
English: See section 4.
Bulgarian: Od 4.
English: Common Common Uncommon Very rare
Bulgarian: Občasni nenormalna hoja
English: What you need to know before you take Memantine LEK
Bulgarian: Kaj morate vedeti, preden boste vzeli zdravilo Memantin LEK Ne jemljite zdravila Memantin LEK
English: organizacna zlozka Tel: + 421-2/48 200 600
Bulgarian: Slovenská republika Sandoz d.d. organizacna zlozka Tel: + 421-2/48 200 600
English: How to take Memantine LEK
Bulgarian: Kako jemati zdravilo Memantin LEK
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Bulgarian: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
English: Thereafter, the clinical benefit of memantine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines.
Bulgarian: Potem je treba ocenjevati klinično korist in prenašanje zdravljenja z memantinom skladno
English: 5.1 Pharmacodynamic properties
Bulgarian: 5.1 Farmakodinamične lastnosti
English: Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Bulgarian: , 6, Dervenakion str., 15351 Pallini, Attiki, Grčija Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
English: Yellow, oval film-coated tablet scored in one side.
Bulgarian: Rumene, ovalne filmsko obložene tablete, z razdelilno zarezo na eni strani.
English: 10 mg: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E
Bulgarian: Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E 171), smukec in rumen železov oksid (E 172).
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 56, 98 and 100 filmcoated tablets.
Bulgarian: Al-PVC/PVDC pretisni omoti v kartonskih škatlah, ki vsebujejo 28, 30, 42, 56, 98 in 100 filmsko obloženih tablet.
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20
Bulgarian: s peroralnim memantinom 14C se je v 20 dneh izločilo povprečno 84% odmerka, od tega več kot 99 % preko ledvic.
English: Memantine LEK is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Bulgarian: Zdravilo Memantin LEK ni priporočljivo uporabljati pri otrocih in mladostnikih mlajših od 18 let,
English: There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
Bulgarian: Možna je povezava med tem kopičenjem
English: In patients with severe renal impairment (creatinine clearance 5 - 29 mL/min) daily dose should be 10 mg per day.
Bulgarian: s hudo okvaro delovanja ledvic (očistek kreatinina 5 - 29 ml/min) naj bo dnevni odmerek 10 mg.
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 50, 56, 60, 98, 100 and 112 film-coated tablets.
Bulgarian: Al-PVC/PVDC pretisni omoti v kartonskih škatlah, ki vsebujejo 28, 30, 42, 50, 56, 60, 98, 100 in 112 filmsko obloženih tablet.
English: MARKETING AUTHORISATION HOLDER
Bulgarian: IMETNIK DOVOLJENJA
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine LEK reassessed by your doctor on a regular basis.
Bulgarian: Vaš zdravnik naj redno ocenjuje klinično korist zdravila Memantin LEK.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets
Bulgarian: IME ZDRAVILA Memantin LEK 10 mg filmsko obložene tablete
English: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Bulgarian: Jedro tablete mikrokristalna celuloza premrežen natrijev karmelozat brezvoden koloidni
English: In particular, Memantine LEK may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Bulgarian: teh lahko spremenijo in bo morda vaš zdravnik moral prilagoditi odmerek:
English: Reporting of side effects
Bulgarian: Poročanje o neželenih učinkih
English: amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (or any combination with hydrochlorothiazide) anticholinergics (substances generally used to treat movement disorders or intestinal cramps) anticonvulsants (substances used to prevent and relieve seizures) barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine) neuroleptics (substances used in the treatment of mental disorders) oral anticoagulants
Bulgarian: cimetidin, ranitidin, prokainamid, kinidin, kinin, nikotin hidroklorotiazid (ali kombinacije zdravil, ki vsebujejo hidroklorotiazid)
English: The film-coated tablets can be taken with or without food.
Bulgarian: Filmsko obložene tablete se lahko jemlje
English: Standard clinical procedures to remove active substance material, e.g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
Bulgarian: Antidota za zastrupitev ali preveliko odmerjanje ni. Pri odstranjevanju učinkovine uporabljamo ustrezne standardne klinične postopke, kot so izpiranje želodca, medicinsko oglje (preprečevanje možne enterohepatične recirkulacije), nakisanje urina, prisilna diureza.
English: Ataxia and other preclinical signs have preceded the vacuolisation and necrosis.
Bulgarian: se je pojavila ataksija in drugi predklinični znaki.
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).
Bulgarian: s placebom (analiza opazovanih primerov po lestvici CIBIC-plus (vtis sprememb na podlagi kliničnega intervjuja (CIBIC- clinician's interview based impression of change)), p=0,025; po lestvici ADCS-ADLsev (vprašalnik vsakodnevnih aktivnosti (ADCS-ADLsev-Alzheimer's disease cooperative study - activities of daily living)), p=0,003; testi po SIB (sklop
English: half 10 mg tablet week 2
Bulgarian: teden polovica 10 mg tablete
English: Memantine LEK should be administered orally once a day.
Bulgarian: Zdravilo Memantin LEK je treba jemati enkrat dnevno
English: - If you take a large overdose of Memantine LEK, contact your doctor or get medical advice, as you may need medical attention.
Bulgarian: - Če ste zaužili prevelik odmerek zdravila Memantin LEK, obvestite
English: 6.1 List of excipients
Bulgarian: 6.1 Seznam pomožnih snovi
English: Not applicable.
Bulgarian: Navedba smiselno ni potrebna.
English: one 10 mg tablet week 3
Bulgarian: teden ena 10 mg tableta
English: The patient should take one 20 mg film-coated tablet (20 mg) per day for 7 days.
Bulgarian: Bolnik mora jemati dve 10 mg filmsko obloženi tableti (20 mg) na dan.
English: Each 20 mg tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Bulgarian: Ena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina.
English: Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Bulgarian: Ena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
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.
Bulgarian: s študijami zdravljenja v monoterapiji ter študijami bolnikov, ki so prejemali stabilni odmerek zaviralcev acetilholinesteraze), je pokazala statistično značilen učinek v korist zdravljenja z memantinom pri spoznavnih funkcijah ter globalnih in funkcionalnih področjih.
English: General disorders and administration site conditions
Bulgarian: Splošne težave in spremembe na mestu aplikacije
English: Estonia Tel: + 372 6652405
Bulgarian: Eesti Sandoz d.d. Estonia Tel: + 372 6652405
English: Film-coated tablet.
Bulgarian: 50 filmsko obloženih tablet.
English: Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse events of memantine were noted on fertility.
Bulgarian: Memantin ni bil teratogen pri podganah in zajcih,
English: Memantine LEK acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Bulgarian: NMDA in tako izboljša prenos živčnih
English: EU/1/13/826 /007 28 film-coated tablets EU/1/13/826 /008 30 film-coated tablets EU/1/13/826 /009 42 film-coated tablets EU/1/13/826 /010 56 film-coated tablets EU/1/13/826 /011 98 film-coated tablets EU/1/13/826 /015 100 film-coated tablets
Bulgarian: EU/1/13/826 /007 28 filmsko obloženih tablet EU/1/13/826 /008 30 filmsko obloženih tablet EU/1/13/826 /009 42 filmsko obloženih tablet EU/1/13/826 /010 56 filmsko obloženih tablet EU/1/13/826 /011 98 filmsko obloženih tablet EU/1/13/826 /015 100 filmsko obloženih tablet
English: If you get any side effects, talk to your doctor or pharmacist.
Bulgarian: izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Bulgarian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: • Periodic safety update reports
Bulgarian: Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve za predložitev rednih posodobljenih poročil o varnosti zdravila za to zdravilo
English: 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.
Bulgarian: Sorazmerno veliki čezmerni odmerki (200 mg dnevno oziroma 105 mg dnevno, tri dni)
English: 6.6 Special precautions for disposal
Bulgarian: 6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
English: Common Not known
Bulgarian: Ni znano, ali
English: The patient recovered without permanent sequelae.
Bulgarian: Bolnik je okreval brez
English: Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.
Bulgarian: Čeprav vzročna povezanost ni bila dokazana, je pri bolnikih, ki se sočasno zdravijo
English: Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Bulgarian: Neznana pogostnost (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
English: SPECIAL STORAGE CONDITIONS
Bulgarian: POSEBNI VARNOSTNI UKREPI
English: Talk to your doctor or pharmacist before taking Memantine LEK
Bulgarian: Pred začetkom jemanja zdravila Memantine LEK se posvetujte z zdravnikom ali
English: Dose titration
Bulgarian: PRETISNI OMOT
English: Tel: + 386 1 580 3327
Bulgarian: Lek Pharmaceuticals d.d. Tel: + 386 1 580 3327
English: Polyvinyl alcohol Macrogol 3350
Bulgarian: Obloga tablete polivinilalkohol makrogol 3350 titanov dioksid (E 171)
English: In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
Bulgarian: Pri drugi študiji zdravljenja v monoterapiji pri blagi do zmerni Alzheimerjevi bolezni (skupna ocena KPSS ob vključitvi 11 do 23 točk), v katero je bilo zajetih in naključno razdeljenih 470 bolnikov.
English: How does Memantine LEK work
Bulgarian: Kako deluje zdravilo Memantin LEK
English: CLINICAL PARTICULARS
Bulgarian: KLINIČNI PODATKI
English: 6.5 Nature and contents of container
Bulgarian: Vrsta ovojnine in vsebina
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
Bulgarian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: In short term studies in rats, memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations.
Bulgarian: povzročil nastanek vakuol in nekrozo v nevronih (Olneyeve lezije), vendar le pri odmerkih, ki dajo zelo visoko maksimalno plazemsko koncentracijo.
English: België/Belgique/Belgien Sandoz n.v./s.a.
Bulgarian: België/Belgique/Belgien
English: Tabulated list of adverse reactions
Bulgarian: Seznam neželenih učinkov v preglednici
English: • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is coadministered with HCT or any combination with HCT.
Bulgarian: Ob sočasni uporabi memantina in hidroklorotiazida (HCT) oziroma zdravil, ki vsebujejo HCT, lahko pride do zmanjšanja serumske koncentracije HCT.
English: Tablet coat
Bulgarian: ZA TABLETE
English: No data on the use of memantine in patients with severe hepatic impairment are available.
Bulgarian: Podatkov o uporabi memantina pri bolnikih
English: Dyspnoea
Bulgarian: Odmerek
English: PHARMACEUTICAL FORM
Bulgarian: NAČIN IZDAJANJA ZDRAVILA
English: Package leaflet: Information for the user Memantine LEK 10 mg film-coated tablets Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Bulgarian: Navodilo za uporabo Memantin LEK 10 mg filmsko obložene tablete Memantin LEK 20 mg filmsko obložene tablete memantinijev klorid
English: Tel: + +420 225 775 111
Bulgarian: Sandoz s.r.o. Tel: + +420 225 775 111
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Bulgarian: Ena filmsko obložena tableta vsebuje 20 mg memantinijevega klorida, kar ustreza 16,62 mg memantina.
English: Dose
Bulgarian: Dojenje
English: p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Bulgarian: CIBIC-plus (vtis sprememb na podlagi kliničnega intervjuja (CIBIC- clinician's interview based impression of change)), p=0,025; po lestvici ADCS-ADLsev (vprašalnik vsakodnevnih aktivnosti (ADCS-ADLsev-Alzheimer's disease cooperative study - activities of daily living)), p=0,003; testi po SIB (sklop
English: - Keep this leaflet.
Bulgarian: Glejte poglavje
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Bulgarian: Ena filmsko obložena tableta vsebuje 10 mg memantinijevega klorida, kar ustreza 8,31 mg memantina.
English: Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
Bulgarian: teden (15.-21. dan): Bolnik mora sedem dni jemati eno 15 mg filmsko obloženo tableto na dan.
English: There was no evidence of any carcinogenicity in life long studies in mice and rats.
Bulgarian: V šudijah na miših in podganah, ki so potekale celo življenjsko dobo, niso opazili karcinogenosti.
English: • The active substance is memantine hydrochloride.
Bulgarian: Učinkovina je memantinijev klorid.
English: Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Bulgarian: teden (1.-7. dan): Bolnik mora sedem dni jemati eno 5 mg filmsko obloženo tableto na dan.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Bulgarian: Memantin LEK 20 mg filmsko obložene tablete memantinijev klorid
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Bulgarian: Klinične študije V temeljno klinično študijo je bilo vključenih 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo, ki so ob vključitvi pri kratkem preizkusu spoznavnih sposobnosti (MMSE - mini-mental state examination) dosegli 3-14 točk. Po 6-mesečni monoterapiji z memantinom se je pri opazovanih bolnikih pokazalo
English: This effect is known from other active substances with cationic amphiphilic properties.
Bulgarian: s kationskimi amfifilnimi lastnostmi.
English: Elevated liver function test Hepatitis
Bulgarian: Bolezni jeter, žolčnika in žolčevodov Pogosti zvišane vrednosti testov jetrne funkcije
English: P.T.Hadjigeorgiou Co Ltd Τηλ: + 357 - 25372425
Bulgarian: Τηλ: + 357 - 25372425
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Bulgarian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Bulgarian: UPORABE ZDRAVILA Pred uporabo preberite navodilo za uporabo.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets
Bulgarian: Memantin LEK 20 mg filmsko obložene tablete
English: Fertility
Bulgarian: Plodnost
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets memantine hydrochloride
Bulgarian: Memantin LEK 10 mg filmsko obložene tablete memantinijev klorid
English: The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment.
Bulgarian: Prenašanje in odmerjanje memantina je treba redno ocenjevati,
English: Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but not in monkeys.
Bulgarian: so pri glodalcih in psih, ne pa tudi pri opicah, občasno opazili spremembe na očeh.
English: No adverse reactions of memantine were noted on male and female fertility.
Bulgarian: s plodnostjo pri moških ali ženskah niso opazili.