FrancophonIA/ELRC3.0 huggingface dataset:
English: There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
Slovenian: Možna je povezava med tem kopičenjem in nastankom vakuol v pljučih.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del večkratnega pakiranja se ne sme prodajati ločeno.
English: Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours.
Slovenian: Memantin se izloča na monoekspotencialni način s končnim razpolovnim časom (t½) 60 do 100 ur.
English: No specific antidote for intoxication or overdose is available.
Slovenian: Antidota za zastrupitev ali preveliko odmerjanje ni na voljo.
English: For detailed instructions on the preparation and handling of the product see section 6.6.
Slovenian: Za podrobna navodila o pripravi in ravnanju s produktom glejte poglavje 6.6.
English: The treatment scheme is also indicated on the treatment initiation pack.
Slovenian: Shema zdravljenja je prikazana tudi na ovojnini za začetek zdravljenja.
English: 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.
Slovenian: 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.
English: Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
Slovenian: O prekinitvi zdravljenja z memantinom je treba razmisliti, ko ni več dokazov o zdravilnem učinku ali če bolnik zdravljenja ne prenaša.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostosti so neželeni učinki navedeni po padajoči resnosti.
English: Memantine should not be used during pregnancy unless clearly necessary.
Slovenian: Memantina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Slovenian: Alzheimerjeva bolezen je povezana z depresijo, samomorilnimi mislimi in samomorom.
English: Pharmacotherapeutic group: Other Anti-dementia drugs, ATC code: N06DX01.
Slovenian: Farmakoterapevtska skupina: druga zdravila za zdravljenje demence, oznaka ATC: N06DX01.
English: It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
Slovenian: Modulira učinke patološko zvišanih toničnih vrednosti glutamata, ki lahko vodijo v nevronsko disfunkcijo.
English: Once opened, the contents of the bottle should be used within 3 months.
Slovenian: Po odprtju je potrebno vsebino stekleničke porabiti v 3 mesecih.
English: Balance disorder
Slovenian: Motnje ravnotežja
English: Instruction for proper use of the pump
Slovenian: Navodilo za pravilno uporabo črpalke
English: There is no indication that food influences the absorption of memantine.
Slovenian: Kot kaže, hrana ne vpliva na absorpcijo memantina.
English: Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Slovenian: Previdnost se priporoča pri bolnikih z epilepsijo, s krči v anamnezi ali pri bolnikih z dejavniki nagnjenosti k epilepsiji.
English: Push down the dosing pump head in a firm but calm and steady manner - not too slowly (fig. 7, fig. 8).
Slovenian: Odmerno črpalko pritiskajte navzdol odločno, a mirno in enekomerno - ne prepočasi (sl. 7, sl. 8).
English: The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment.
Slovenian: Prenašanje in odmerjanje memantina je treba redno ocenjevati, najbolje v prvih treh mesecih po začetku zdravljenja.
English: In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
Slovenian: V prospektivno opredeljeni primarni analizi ni bilo statistično značilnih razlik pri primarnih ciljih študije v 24. tednu.
English: Tabulated list of adverse reactions
Slovenian: Tabeliran seznam neželenih reakcij
English: This medicinal product does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila niso potrebni posebni pogoji.
English: This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.
Slovenian: Ta odmerek boste povečevali vsak teden za 5 mg, dokler ne boste dosegli priporočenega (vzdrževalnega) odmerka.
English: Hallucinations1
Slovenian: Halucinacije1
English: Treatment of patients with moderate to severe Alzheimer's disease.
Slovenian: Zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
English: The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Slovenian: V možganih se nahajajo tako imenovani receptorji N-metil-D-aspartata (NMDA, ki sodelujejo v prenosu živčnih signalov, ki so pomembni za učenje in spomin.
English: Elevated liver function test
Slovenian: Zvišani testi jetrne funkcije
English: The same may be true for ketamine and dextromethorphan (see also section 4.4).
Slovenian: Podobno velja za ketamin in dekstrometorfan (glejte tudi poglavje 4.4).
English: Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins.
Slovenian: V ledvično delovanje je vključena tudi tubularna reabsorpcija, verjetno preko beljakovinskega kationskega transporta.
English: As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Slovenian: Posledično so na voljo le omejeni podatki, zato priporočamo skrben nadzor bolnikov z omenjenimi obolenji.
English: To benefit from your medicine you should take it regularly every day at the same time of the day.
Slovenian: Da bi imeli od zdravila koristi, ga morate jemati redno, vsak dan ob istem času.
English: The dosing pump head should not be pushed down while in the locked position.
Slovenian: Glave odmerne črpalke ne smemo pritiskati navzdol, ko je v zaklenjenem položaju.
English: Memantine Merz is not recommended for children and adolescents under the age of 18 years.
Slovenian: Zdravila Memantine Merz ne priporočajo otrokom in mladostnikom, mlajšim od 18 let.
English: In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Slovenian: V večini kliničnih preskušanj so bili bolniki z nedavnim srčnim infarktom, dekompenziranim kongestivnim srčnim popuščanjem (NYHA III-IV) ali neurejeno hipertenzijo izključeni.
English: Once daily
Slovenian: Enkrat na dan
English: Pancreatitis2
Slovenian: Pankreatitis2
English: Date of first authorisation: 22 Nov 2012 Date of latest renewal: {DD month YYYY}
Slovenian: Datum prve pridobitve dovoljenja: 22 november 2012 Datum zadnjega podaljšanja dovoljenja: dd/mm/yyyy
English: • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Slovenian: • Sočasni uporabi memantina in amantadina se je potrebno izogniti, ker lahko pride do pojava farmakotoksične psihoze.
English: The patient recovered without permanent sequelae.
Slovenian: Bolnik je okreval brez trajnih posledic.
English: The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Slovenian: V primeru alkalnega urina lahko pride do zmanjšane hitrosti izločanja memantina za faktor 7 do 9 (glejte poglavje 4.4).
English: • In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Slovenian: • V okviru postmarketinških izkušenj so poročali o osamljenih primerih povečanja mednarodno umerjenega razmerja (INR) pri bolnikih, ki so bili sočasno zdravljeni z varfarinom.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: „Possible side effects“.
Slovenian: »Možni neželeni učinki«.
English: In general, the observed side effects are mild to moderate.
Slovenian: Na splošno so opaženi neželeni učinki blagi do zmerni.
English: - If you find you have forgotten to take your dose of Memantine Merz, wait and take your next dose at the usual time.
Slovenian: - ce ste ugotovili, da ste pozabili vzeti predpisani odmerek zdravila Memantine Merz, počakajte in vzemite naslednji odmerek ob običajnem času.
English: There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Slovenian: Na voljo je tudi objavljen klinični primer o morebitnem tveganju sočasne uporabe memantina in fenitoina.
English: The dosing pump should be locked after use.
Slovenian: Odmerno črpalko je treba po uporabi zakleniti.
English: If the pump does not function as described during intended use and according to instruction, the patient should consult the treating physician or a pharmacist.
Slovenian: Če odmerna črpalka med uporabo, za katero je namenjena ne deluje, kot je opisano in v skladu z navodili, se naj bolnik posvetuje s svojim zdravnikom ali s farmacevtom.
English: If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Slovenian: V primeru, da imate renalno okvaro (težave z ledvicami), naj vaš zdravnik skrbno nadzira delovanje ledvic in po potrebi ustrezno prilagodi odmerke memantina.
English: The dosing pump head can then be released and is ready for the next pump actuation.
Slovenian: Glavo odmerne črpalke lahko nato spustimo in pripravljena je za naslednji pritisk navzdol.
English: This effect was only observed at high doses in rodents.
Slovenian: Ta učinek so opazili le pri visokih odmerkih pri glodalcih.
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.
Slovenian: • 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.
English: Very rare (may affect up to 1 in 10,000 users): • Seizures
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): • epileptični napadi
English: The dosing pump is then ready for use.
Slovenian: Odmerna črpalka je tako pripravljena za uporabo.
English: The tablet can be divided into equal doses.
Slovenian: Tableto je mogoče razdeliti na dve enaki polovici.
English: 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.
Slovenian: Če bolnik zdravljenje dobro prenaša, se lahko odmerek po najmanj 7 dneh zdravljenja zviša na do 20 mg dnevno, po standardni titracijski shemi.
English: Slide the plastic dip tube carefully into the bottle.
Slovenian: Plastično cevko previdno vstavite v stekleničko.
English: The tablets can be taken with or without food.
Slovenian: Tablete lahko jemljete s hrano ali brez.
English: 20 mg tablets once a day
Slovenian: 20 mg tableta enkrat dnevno
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Neznane pogostnosti (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Slovenian: V najekstremnejšem primeru prevelikega odmerjanja je bolnik preživel peroralni vnos 2000 mg memantina z učinki na centralni živčni sistem (desetdnevna koma, kasneje diplopija in vznemirjenost).
English: Take one tablet once a day.
Slovenian: Vzemite eno tableto na dan.
English: 50 ml (and 10 x 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles (Hydrolytic Class III).
Slovenian: 50 ml (in 10 × 50 ml) v rjavih stekleničkah (hidrolitski razred II) in 100 ml v rjavih stekleničkah
English: shortness of breath, high blood pressure and drug hypersensitivity
Slovenian: zasoplost, visok krvni tlak in preobčutljivost za zdravilo
English: Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Slovenian: Prav tako se lahko zviša pH urina v primeru ledvične tubularne acidoze (RTA) ali pri hudi okužbi mehurja, ki ga povzročajo bakterije vrste Proteus.
English: One tablet daily
Slovenian: Ena tableta na dan
English: <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: <1/1.000); zelo redki (<1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Week 2 (day 8-14):
Slovenian: 4. teden (22.-28. dan):
English: Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery.
Slovenian: Zmerna do huda Alzheimerjeva bolezen je običajno sama vzrok za nesposobnost vožnje in upravljanja s stroji.
English: In volunteers with normal kidney function, total clearance (Cltot) amounts to 170 ml/min/1.73 m² and part of total renal clearance is achieved by tubular secretion.
Slovenian: Pri prostovoljcih z normalnim delovanjem ledvic je celoten očistek (Cltot) 170 ml/min/1,73 m²; del celotnega ledvičnega očistka je dosežen s pomočjo tubularne sekrecije.
English: This effect is known from other active substances with cationic amphiphilic properties.
Slovenian: Ta učinek je poznan pri zdravilnih učinkovinah s kationskimi amfifilnimi lastnostmi.
English: Specific ophthalmoscopic examinations in clinical studies with memantine did not disclose any ocular changes.
Slovenian: Specifične oftalmoskopske preiskave v raziskavah z memantinom niso razkrile sprememb na očeh.
English: Excipients: Each one millilitre of solution contains 100 mg sorbitol (E 420) and 0.5 mg potassium, see section 4.4.
Slovenian: Pomožne snovi: En mililiter raztopine vsebuje 100 mg sorbitola (E 420) in 0,5 mg kalija, glejte poglavje 4.4.
English: Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Slovenian: Memantin in vitro ni zaviral CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monooksigenaze, ki vsebuje flavin, epoksidne hidroksilaze ali sulfatacije.
English: The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Slovenian: Priporočen vzdrževalni odmerek je 20 mg enkrat dnevno, kar boste dosegli na začetku četrtega tedna.
English: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.
Slovenian: Pri bolnikih z blago ali zmerno jetrno okvaro (Child-Pugh A in Child-Pugh B) prilagoditev odmerka ni potrebna.
English: Place the bottle on a flat, horizontal surface, for example a table top, and only use it in a upright position.
Slovenian: Postavite stekleničko na ravno vodoravno površino, na primer na mizo, in jo uporabljate samo v navpičnem položaju.
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.
Slovenian: Ni znano, ali se memantin izloča v materino mleko, čeprav bi iz njegove lipofilnosti lahko sklepali, da se.
English: Multipack 500 ml, comprising 10 packs, each containing 1 bottle with 50 ml oral solution.
Slovenian: Večkratno pakiranje s 500 ml sestoji iz 10 pakiranj, od katerih vsako vsebuje 1 stekleničko s 50 ml peroralne raztopine.
English: In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Slovenian: Pri znakih in simptomih splošne prekomerne stimulacije centralnega živčnega sistema (OŽS) je treba razmisliti o previdnem simptomatičnem kliničnem zdravljenju.
English: 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).
Slovenian: 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).
English: Memantine Merz oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml).
Slovenian: Memantine Merz peroralna raztopina je na voljo v stekleničkah po 50 ml, 100 ml ali v večkratnem pakiranju po 500 ml (10 x 50 ml).
English: As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
Slovenian: Ker ti učinki niso bili opaženi v dolgotrajnih študijah pri glodavcih ali drugih živalih, je klinična pomembnost teh pojavov neznana.
English: Both compounds are chemically related NMDA-antagonists.
Slovenian: Obe učinkovini sta kemijsko sorodna antagonista NMDA.
English: The solution must not be poured or pumped into the mouth directly from the bottle or the pump, but should be dosed onto a spoon or into a glass of water using the pump.
Slovenian: Raztopine ne smemo vlivati ali črpati v usta neposredno iz stekleničke oziroma črpalke, temveč jo je potrebno s črpalko odmeriti na žlico ali v kozarec vode.
English: Your doctor should assess your treatment on a regular basis.
Slovenian: Vaš zdravnik naj redno preverja učinek zdravljenja.
English: When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated.
Slovenian: Ob dnevnih odmerkih 5 do 30 mg so izračunali razmerje cerebrospinalni likvor (CSL)/serum 0,52.
English: Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
Slovenian: Sočasno dajanje memantina in spazmolitikov, dantrolena ali baklofena lahko spremeni njihove učinke, zato je morda potrebno prilagoditi odmerke.
English: In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Slovenian: V teh primerih bo vaš zdravnik nadzoroval ledvično delovanje v določenih časovnih intervalih.
English: • 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.
Slovenian: • 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.
English: To do this, the dosing pump head has to be turned in the direction of the arrow about one eighth of a turn, until a resistance is felt (fig. 4).
Slovenian: Da to storimo, moramo glavo odmerne črpalke obračati v smeri puščice približno za eno osmino obrata, dokler ne začutiomo upora (sl. 4).
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with Memantine Merz and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Memantine Merz did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Slovenian: V kliničnih preskušanjih bolnikov z zmerno do hudo demenco, ki so zajeli 1784 bolnikov, zdravljenih z zdravilom Memantine Merz in 1595 bolnikov, ki so prejemali placebo, se skupna incidenca neželenih učinkov pri zdravilu Memantine Merz ni razlikovala od placeba, neželeni učinki pa so bili po resnosti večinoma blagi do zmerni.
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.
Slovenian: Potem je treba ocenjevati klinično korist in prenašanje zdravljenja z memantinom v skladu s trenutno veljavnimi kliničnimi smernicami.
English: Hold a glass with a little water or a spoon below the nozzle.
Slovenian: Pod cevnim izvodilom pridržite kozarec z malo vode ali žlico.
English: - If you take a large overdose of Memantine Merz, contact your doctor or get medical advice, as you may need medical attention.
Slovenian: - v primeru, da ste zaužili prevelik odmerek zdravila Memantine Merz, obvestite svojega zdravnika ali se obrnite po nasvet na zdravstveno službo, ker boste morda potrebovali zdravniško obravnavo.
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.
Slovenian: 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.
English: Prior to first use the dosing pump has to be screwed on the bottle.
Slovenian: Pred prvo uporabo je treba odmerno črpalko priviti na stekleničko.
English: In particular, Memantine Merz may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Slovenian: Posebno v primeru, da skupaj z zdravilom Memantine Merz jemljete naslednja zdravila, se učinki le teh lahko spremenijo in bo morda vaš zdravnik moral prilagoditi odmerek:
English: In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly higher than at human exposure.
Slovenian: Pri podganah so ugotovili zmanjšano rast ploda v odmerkih, ki so bili primerljivi ali malo višji kot pri ljudeh.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovaje in izdaja zdravila je le s posebnim režimom (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: At the beginning of treatment you will start by using Memantine Merz 5 mg film-coated tablets once a day.
Slovenian: Na začetku boste zdravljenje začeli z jemanjem zdravila Memantine Merz 5 mg filmsko obložene tablete enkrat dnevno.
English: In the event of overdose, treatment should be symptomatic.
Slovenian: Pri prevelikem odmerjanju je potrebno simptomatično zdravljenje.
English: For the intended use the dosing pump is only screwed on once when starting the use, and should never be unscrewed.
Slovenian: Ko nameravamo uporabljati odmerno črpalko, jo privijemo samo enkrat ob začetku uporabe in je nikdar več ne odvijemo.
English: Dosage in patients with impaired kidney function
Slovenian: Odmerjanje pri bolnikih z ledvično okvaro
English: Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient.
Slovenian: Zdravljenje naj se začne le v primeru, če je na voljo ustrezna oseba, ki za bolnika skrbi in ki lahko nadzoruje redno jemanje zdravila.
English: Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.
Slovenian: Čeprav vzročna povezanost ni bila ugotovljena, je pri bolnikih, ki se sočasno zdravijo s peroralnimi antikoagulanti, priporočljivo spremljanje protrombinskega časa ali INR.