natgillin/translations-raw huggingface dataset:
Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms.
Sorazmerno veliki čezmerni odmerki (200 mg na dan oziroma 105 mg na dan, tri dni) so bili povezani samo s simptomi utrujenosti, šibkosti in/ali driske ali pa simptomov sploh ni bilo.
Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Neznana pogostnost (pogostosti iz razpoložljivih podatkov ni mogoče oceniti): • vnetje trebušne slinavke, vnetje jeter (hepatitis) in psihotične reakcije
Do not take Memantine Mylan: - if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Memantin Mylan: - če ste alergični na memantin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom.
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire EN6 1 TL, Velika Britanija
Linearity Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Študije na zdravih prostovoljcih so pokazale, da ima memantin linearno farmakokinetiko v razponu odmerkov od 10 do 40 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 do 20 mg na dan, po standardni titracijski shemi.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Posledično je za bolnike z omenjenimi obolenji na voljo le omejeno število podatkov, zato je priporočljiv skrben nadzor teh bolnikov.
2 Isolated cases reported in post-marketing experience.
2Posamezni primeri, o katerih so poročali v okviru izkušenj v obdobju trženja zdravila.
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 nagnjenostjo k epilepsiji.
There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Na voljo je tudi objavljen klinični primer o morebitnem tveganju pri sočasni uporabi memantina in fenitoina.
1, Hungary.
1, Madžarska
Very rare (may affect up to 1 in 10,000 people): • Seizures
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): • epileptični napadi
The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
V možganih se nahajajo tako imenovani receptorji N-metil-D-aspartata (NMDA), ki sodelujejo v prenosu živčnih signalov, pomembnih za učenje in spomin.
BATCH NUMBER Lot
ŠTEVILKA SERIJE LOT
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.
Pri prostovoljcih z normalnim delovanjem ledvic je celoten očistek (Cltot) 170 ml/min/1,73 m²; del celotnega ledvičnega očistka je dosežen s tubularno sekrecijo.
The most frequently occurring adverse reactions with a higher incidence in the memantine 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 memantin, 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 %).
Pregnancy The use of memantine in pregnant women is not recommended.
Nosečnost Uporaba memantina pri nosečnicah ni priporočljiva.
• 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.
• Ostale učinkovine, kot so cimetidin, ranitidin, prokainamid, kinidin, kinin in nikotin, ki uporabljajo isti ledvični kationski transportni sistem kot amantadin, prav tako lahko medsebojno reagirajo z memantinom, kar lahko vodi do povišanih vrednosti v plazmi.
In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
V prospektivno opredeljeni primarni analizi v 24. tednu ni bilo statistično značilnih razlik pri primarnih ciljih študije.
Memantine Mylan should be administered orally once a day and should be taken at the same time every day.
Zdravilo Memantin Mylan je treba jemati peroralno enkrat dnevno ter ga zaužiti vsak dan ob istem času.
In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20 days, more than 99% being excreted renally.
V študiji s peroralnim memantinom 14C se je v 20 dneh izločilo povprečno 84 % odmerka, od tega več kot 99 % preko ledvic.
Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on fertility.
Memantin ni bil teratogen pri podganah in zajcih, tudi pri odmerkih, toksičnih za mater, prav tako pa niso opazili neželenih učinkov na rodnost.
What Memantine Mylan is and what it is used for What you need to know before you take Memantine Mylan How to take Memantine Mylan Possible side effects
Kaj je zdravilo Memantin Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Memantin Mylan Kako jemati zdravilo Memantin Mylan Možni neželeni učinki
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
Pri bolnikih z blago ali zmerno jetrno okvaro (Child-Pugh A in Child-Pugh B) prilagoditev odmerjanja ni potrebna.
If you go into hospital, let your doctor know that you are taking Memantine Mylan.
V primeru, da ste sprejeti v bolnišnico, obvestite zdravnika, da jemljete zdravilo Memantin Mylan.
- If you take a large overdose of Memantine Mylan, contact your doctor or get medical advice, as you may need medical attention.
- Če ste zaužili prevelik odmerek zdravila Memantin Mylan, obvestite zdravnika, ker boste morda potrebovali zdravniško obravnavo.
What Memantine Mylan is and what it is used for
Kaj je zdravilo Memantin Mylan in za kaj ga uporabljamo
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg film-coated tablets or one 20 mg film-coated tablet once a day) as described above.
Na podlagi kliničnih študij je priporočeni odmerek za bolnike, starejše od 65 let, 20 mg na dan (dve 10-miligramski filmsko obloženi tableti ali eno 20-miligramsko filmsko obloženo tableto enkrat na dan), kot je opisano zgoraj.
Furthermore, memantine has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Tudi memantin lahko blago ali zmerno vpliva na sposobnost vožnje in upravljanja strojev, zato je potrebno bolnike opozoriti, da morajo biti posebno previdni.
It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs.
Ni znano ali se memantin izloča v materino mleko, vendar bi iz njegove lipofilnosti lahko sklepali, da se.
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 vzrok za nesposobnost vožnje in upravljanja strojev.
Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
Sočasno dajanje memantina in spazmolitikov, dantrolena ali baklofena lahko spremeni njihove učinke, zato bo morda potrebna prilagoditev odmerkov.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
In particular, Memantine Mylan may change the effects of the following medicines and their dose may need to be adjusted by your doctor: - 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
Posebno v primeru, če skupaj z zdravilom Memantin Mylan jemljete naslednja zdravila, se lahko njihovi učinki spremenijo in bo zdravnik morda moral prilagoditi odmerek: - amantadin, ketamin, dekstrometorfan - dantrolen, baklofen - cimetidin, ranitidin, prokainamid, kinidin, kinin, nikotin - hidroklorotiazid (ali kombinacije zdravil, ki vsebujejo hidroklorotiazid) - antiholinergiki (zdravila, ki se običajno uporabljajo za zdravljenje motenj gibanja in trebušnih krčev) - antikonvulzivi (zdravila za preprečevanje ali lajšanje epileptičnih krčev) - barbiturati (zdravila, ki se na splošno uporabljajo kot uspavala) - dopaminergični agonisti (učinkovine kot so L-dopa, bromokriptin) - nevroleptiki (zdravila za zdravljenje duševnih motenj) - peroralni antikoagulanti
Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.
Čeprav vzročna povezanost ni bila dokazana, je pri bolnikih, ki se sočasno zdravijo s peroralnimi antikoagulanti, priporočljivo spremljanje protrombinskega časa ali INR.
Hallucinations1
Občasni halucinacije1
In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
V kliničnih preskušanjih bolnikov z zmerno do hudo demenco, ki so zajela 1784 bolnikov, zdravljenih z memantinom in 1595 bolnikov, ki so prejemali placebo, se skupna incidenca neželenih učinkov pri memantinu ni razlikovala od placeba, neželeni učinki pa so bili po resnosti večinoma blagi do zmerni.
When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p< 0.0001).
Pri bolnikih, kjer so ocenili hkratno poslabšanje vseh treh področij, so rezultati pokazali statistično značilen učinek memantina pri preprečevanju poslabšanja, saj se je pokazalo poslabšanje pri dvakrat več bolnikih, ki so prejemali placebo, kot pri bolnikih, zdravljenih z memantinom, na vseh treh področjih (21 % proti 11 %, p < 0,0001).
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.
Meta-analiza bolnikov z zmerno do hudo Alzheimerjevo boleznijo (skupna ocena KPSS ob vključitvi <20 točk), ki je zajela šest študij III. faze, nadzorovanih s placebom in trajajočih 6 mesecev (vključno 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.
The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Pri alkalnem urinu lahko pride do za 7- do 9-krat zmanjšane hitrosti izločanja memantina (glejte poglavje 4.4).
Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4- and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane.
Pri človeku so najpomembnejši presnovki N-3,5-dimetil-gludantan, izomerna mešanica 4- in 6-hidroksi-memantina in 1- nitrozo-3,5-dimetil-adamantana.
The tablets can be divided into equal doses and can be taken with or without food.
Tablete lahko razdelite na dva enaka odmerka in ju lahko jemljete s hrano ali brez nje.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Če imate ledvično okvaro (težave z ledvicami), naj vaš zdravnik skrbno nadzira delovanje vaših ledvic in po potrebi ustrezno prilagodi odmerke memantina.
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.
Potem je treba ocenjevati klinično korist in prenašanje zdravljenja z memantinom skladno s trenutno veljavnimi kliničnimi smernicami.
Memantine Mylan is used for the treatment of patients with moderate to severe Alzheimer's disease.
Zdravilo Memantin Mylan uporabljamo za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
In the event of overdose, treatment should be symptomatic.
Pri prevelikem odmerku je potrebno simptomatsko zdravljenje.
The usual starting dose is half a 10 mg tablet once a day (5 mg) for the first week.
Običajni začetni odmerek je polovica 10-miligramske tablete enkrat na dan (5 mg) v prvem tednu.
McDermott Laboratories Ltd. T/A Gerard Laboratories Unit 35 Baldoyle Industrial Estate Grange Road
McDermott Laboratories Ltd. T/A Gerard Laboratories Unit 35 BaldoyleIndustrial Estate Grange Road
In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
V klinični raziskavi pri mladih zdravih osebah niso opazili pomembnega vpliva memantina na farmakokinetiko galantamina.
If you take more Memantine Mylan than you should - In general, taking too much Memantine Mylan should not result in any harm to you.
Če ste vzeli večji odmerek zdravila Memantin Mylan, kot bi smeli - Na splošno zaužitje večjega odmerka zdravila Memantin Mylan ne bi smelo imeti škodljivih posledic.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake »Uporabno do:«.
Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but not in monkeys.
V študijah toksičnosti pri ponavljajočih odmerkih so pri glodalcih in psih, ne pa tudi pri opicah, občasno opazili spremembe na očeh.
How to store Memantine Mylan Contents of the pack and other information
Shranjevanje zdravila Memantin Mylan Vsebina pakiranja in dodatne informacije
What you need to know before you take Memantine Mylan
Kaj morate vedeti, preden boste vzeli zdravilo Memantin Mylan
• In post-marketing experience, isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
• V okviru izkušenj iz obdobja trženja so pri bolnikih, ki so bili sočasno zdravljenji z varfarinom, poročali o posameznih primerih povečanja mednarodnega umerjenega razmerja (INR).
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In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Pri prevelikih odmerkih do 140 mg ali pri neznanih odmerkih so se pri bolnikih pokazali simptomi, povezani s centralnim živčnim sistemom (zmedenost, dremavost, zaspanost, vrtoglavica, vznemirjenost, agresivnost, halucinacije in motnje ravnotežja) in/ali prebavili (bruhanje in driska).
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance active substance interaction of memantine with glyburide/metformin or donepezil was observed.
V raziskavah farmakokinetike (PK) posameznega odmerka pri mladih zdravih osebah ni bilo opaziti interakcij memantina z gliburidom/metforminom ali donepezilom.
Pancreatitis2
Neznana pankreatitis2
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Če imate ledvično okvaro, vam bo zdravnik prilagodil odmerek v skladu z vašim stanjem.
The film-coated tablets can be taken with or without food.
Filmsko obložene tablete lahko bolnik zaužije s hrano ali brez nje.
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
Pri bolnikih, zdravljenih z memantinom, se je pokazal statistično značilno boljši učinek kot pri bolnikih, ki so prejemali placebo pri primarnih ciljih študije: lestvica za ocenjevanje Alzheimerjeve bolezni (ADAS-cog-Alzheimer´s disease assessment scale) (p=0,003) in CIBIC-plus (p=0,004) po 24 tednih (prenos zadnjega opažanja (LOCF-last observation carried forward)).
Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5 - 1 μmol) with large interindividual variations.
Ob dnevnih odmerkih po 20 mg so v stanju dinamičnega ravnovesja dosežene plazemske koncentracije memantina od 70 do 150 ng/ml (0,5 - 1 µmol), z veliko variabilnostjo med posamezniki.
Talk to your doctor or pharmacist before taking Memantine Mylan - if you have a history of epileptic seizures - if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
Pred začetkom jemanja zdravila Memantin Mylan se posvetujte z zdravnikom ali farmacevtom: - če ste v preteklosti imeli epileptične napade, - če ste pred kratkim preboleli srčni infarkt (srčno kap), če imate kongestivno srčno popuščanje ali neurejeno hipertenzijo (visok krvni tlak).
In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
V teh primerih bo nadzoroval ledvično delovanje v določenih časovnih presledkih.
117 Allée des Parcs, 69800 Saint-Priest, France.
117 Allée des Parcs, 69800 Saint-Priest, Francija
Memantine Mylan belongs to a group of medicines called NMDAreceptor antagonists.
Zdravilo Memantin Mylan spada v skupino zdravil, ki se imenujejo antagonisti receptorjev NMDA.
McDermott Laboratories Ltd. T/A Gerard Laboratories Unit 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
McDermott Laboratories Ltd. T/A Gerard Laboratories Unit 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
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 odmerjanja ni potrebna.
Venous thrombosis/thromboembolism
Občasni venska tromboza/ tromboembolija
Memantine Mylan acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Zdravilo Memantin Mylan deluje na receptorje NMDA in tako izboljša prenos živčnih signalov in spomin.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo za uporabo.
In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
Da bi zmanjšali nevarnost pojava neželenih učinkov, odmerek dosegate postopoma, po priporočilu spodnje sheme dnevnega odmerjanja:
The use of medicinal products called amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Izogniti se je treba sočasni uporabi zdravil, kot so amantadin (za zdravljenje Parkinsonove bolezni), ketamin (običajno se uporablja kot anestetik), dekstrometorfan (običajno se uporablja za zdravljenje kašlja) in ostali zaviralci receptorjev NMDA.
In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Največji dnevni odmerek je 20 mg. Da bi zmanjšali pojavnost neželenih učinkov, je potrebno postopno zviševanje odmerka po 5 mg na teden v prvih treh tednih zdravljenja, dokler ni dosežen vzdrževalni odmerek, kot sledi:
Fertility No adverse reactions of memantine were noted on male and female fertility.
Plodnost Neželenih učinkov memantina v zvezi s plodnostjo pri moških ali ženskah niso opazili.
Only limited experience with overdose is available from clinical studies and post-marketing experience.
Iz kliničnih študij in izkušenj iz obdobja trženja zdravila, so na voljo le omejene izkušnje s prevelikim odmerjanjem.
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).
Po 6-mesečni monoterapiji z memantinom se je pri opazovanih bolnikih pokazalo izboljšanje v primerjavi 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 testov za hudo prizadetost (SIB-severe impairment battery)) p=0,002).
When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated.
Izračunali so, da je pri dnevnih odmerkih od 5 do 30 mg razmerje med koncentracijo v cerebrospinalnem likvorju (CSL) in serumu 0,52.