FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118.
Slovenian: Sočasno dajanje enojnih odmerkov zaviralca P-gp ciklosporina A in fidaksomicina pri zdravih prostovoljcih je povzročilo 4-kratno povečanje Cmax in 2-kratno povečanje AUC fidaksomicina ter 9,5-kratno povečanje Cmax in 4-kratno povečanje AUC glavnega aktivnega presnovka OP-1118.
English: − dizziness, headache
Slovenian: − vrtoglavica, glavobol
English: If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali menite, da ste noseči, se posvetujte s svojim zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: Fidaxomicin does not induce or inhibit CYP450 enzymes in vitro.
Slovenian: Fidaksomicin ne inducira ali zavira encima CYP450 in vitro.
English: Twenty-four percent of patients met at least one of the following three criteria at baseline for scoring severity: body temperature >38.5°C, leukocyte count >15,000, or creatinine value ≥1.5 mg/dl.
Slovenian: Štiriindvajset odstotkov bolnikov je ob izhodišču izpolnjevalo vsaj enega od naslednjih treh kriterijev za resnost ocenjevanja: telesna temperatura > 38,5 °C, število levkocitov
English: If you stop taking DIFICLIR
Slovenian: Če ste prenehali jemati zdravilo DIFICLIR
English: Fidaxomicin is a locally acting drug.
Slovenian: Fidaksomicin je zdravilo, ki deluje lokalno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003-004
Slovenian: EU/1/11/733/003-004
English: Inflammatory bowel disease
Slovenian: Vnetna črevesna bolezen
English: Effect of fidaxomicin on P-gp substrates
Slovenian: Učinek fidaksomicina na substrate P-gp
English: Microcrystalline cellulose Pregelatinised starch (maize) Hydroxypropyl cellulose Butylated hydroxytoluene Sodium starch glycolate Magnesium stearate
Slovenian: Jedro tablete: mikrokristalna celuloza predgelirani škrob (koruzni) hidroksipropilceluloza butilhidroksitoluen natrijev karboksimetil škrob magnezijev stearat
English: − certain blood tests might show changed levels, e.g. increased liver enzymes (alanine aminotransferase)
Slovenian: − občutek napihnjenosti, vetrovi (flatulenca) − določeni krvni testi lahko pokažejo spremenjene vrednosti, npr. povečane jetrne encime (alanin aminotransferaza) − izpuščaj, srbenje (pruritus)
English: Fidaxomicin had no effects on fertility when evaluated in rats (see section 5.3).
Slovenian: Plodnost Fidaksomicin pri podganah ni vplival na sposobnost razmnoževanja (glejte poglavje 5.3).
English: If you take more DIFICLIR than you should
Slovenian: Če ste vzeli večji odmerek zdravila DIFICLIR, kot bi smeli
English: Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.
Slovenian: Zaradi omejenih kliničnih podatkov je treba fidaksomicin uporabljati previdno pri bolnikih s psevdomembranskim kolitisom, s fulminantno ali življenjsko nevarno CDI.
English: Fidaxomicin and the metabolite OP-1118 are substrates of P-gp.
Slovenian: Fidaksomicin in presnovek OP-1118 sta substrata P-gp.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Učinek zaviralcev P-gp na fidaksomicin
English: You should not take DIFICLIR if you are pregnant, unless your doctor tells you otherwise.
Slovenian: Nosečnost in dojenje Ne jemljite zdravila DIFICLIR, če ste noseči, razen če vam vaš zdravnik svetuje drugače.
English: DIFICLIR is an antibiotic which contains the active substance fidaxomicin.
Slovenian: Zdravilo DIFICLIR je antibiotik, ki vsebuje zdravilno učinkovino fidaksomicin.
English: Fidaxomicin is a narrow spectrum antimicrobial drug with bactericidal activity against C. difficile.
Slovenian: Fidaksomicin je ozkospektralni antibiotik z baktericidnim delovanjem na C. difficile.
English: Limited data from patients with an active history of chronic hepatic cirrhosis in the Phase 3 studies showed that median plasma levels of fidaxomicin and OP-1118 may be approximately 2- and 3-fold higher, respectively, than in non-cirrhotic patients.
Slovenian: Maloštevilni podatki bolnikov z aktivno anamnezo kronične hepatične ciroze v študijah 3. faze so pokazali, da so srednje koncentracije fidaksomicina in OP-1118 v plazmi lahko približno 2-krat oz. 3krat višje kot pri bolnikih, ki nimajo ciroze.
English: There are limited data available on the use of fidaxomicin in severe cases of the disease (e.g. pseudomembranous colitis).
Slovenian: Podatkov o uporabi fidaksomicina pri hudih primerih bolezni (npr. psevdomembranski kolitis) je malo.
English: Data from an open label, single arm study in CDI patients with concomitant inflammatory bowel disease (IBD) indicated no major difference in plasma concentrations of fidaxomicin or its main metabolite OP-1118 in patients with IBD as compared with patients without IBD in other studies.
Slovenian: Podatki odprte študije z enim krakom pri bolnikih s CDI s pridruženo vnetno črevesno boleznijo (IBD - inflammatory bowel disease) so pokazali, da ni znatnih razlik v plazemski koncentraciji fidaksomicina ali glavnega presnovka OP-1118 pri bolnikih z IBD v primerjavi z bolniki brez IBD iz drugih študij.
English: In CDI patients, average peak plasma levels of fidaxomicin and its main metabolite OP-1118 tend to be 2- to 6-fold higher than in healthy adults.
Slovenian: Pri bolnikih s CDI so maksimalne koncentracije fidaksomicina in njegovega glavnega presnovka OP-1118 v plazmi 2- do 6-krat višje kot pri zdravih odraslih.
English: Each film-coated tablet contains 200 mg of fidaxomicin.
Slovenian: Ena filmsko obložena tableta vsebuje 200 mg fidaksomicina.
English: If you have kidney or liver problems, ask your doctor for advice before using this medicine.
Slovenian: Če imate težave z ledvicami ali jetri, se posvetujte s svojim zdravnikom, preden uporabite to zdravilo.
English: It interferes with RNA polymerase at a distinct site from that of rifamycins.
Slovenian: Na RNA polimerazo deluje drugače kot rifamicini.
English: Gender, weight and race
Slovenian: Spol, rasa in telesna masa
English: How to take DIFICLIR
Slovenian: Kako jemati zdravilo DIFICLIR
English: Do not stop taking DIFICLIR, unless your doctor has advised you to do so. Keep taking this medicine until the course is finished, even if you feel better.
Slovenian: Zdravilo jemljite, dokler ni zdravljenje končano, tudi če se počutite bolje.
English: Fidaxomicin has been shown to inhibit C. difficile sporulation in vitro.
Slovenian: Ugotovljeno je bilo, da fidaksomicin zavira nastajanje spor C. difficile in vitro.
English: − cyclosporin (a medicine used to dampen down the body's immune reactions, used e.g. after an organ or bone marrow transplant, for psoriasis or eczema, or for rheumatoid arthritis or nephrotic syndrome)
Slovenian: Primeri teh zdravil so: - ciklosporin (zdravilo, ki se uporablja za preprečevanje reakcij imunskega odziva telesa, npr. po presaditvi organa ali kostnega mozga, za psoriazo ali ekcem ali za revmatoidni artritis ali nefrotični sindrom), - ketokonazol (zdravilo, ki se uporablja za zdravljenje glivičnih obolenj),
English: Fidaxomicin is a topically acting drug that cannot be used to treat systemic infections; therefore the establishment of a clinical breakpoint is not relevant.
Slovenian: Fidaksomicin je zdravilo, ki deluje lokalno in ga ni mogoče uporabiti za zdravljenje sistemskih okužb,
English: Following a single dose of 200 mg fidaxomicin, the majority of the administered dose (over 92%) was recovered in the stool as fidaxomicin or its metabolite OP-1118 (66%).
Slovenian: Izločanje Po enkratnem odmerku 200 mg fidaksomicina je bila večina danega odmerka (preko 92%) ugotovljena v blatu kot fidaksomicin ali njegov presnovek OP-1118 (66%).Glavne poti izločanja sistemsko razpoložljivega fidaksomicina niso bile določene.
English: Fidaxomicin is a substrate of P-gp.
Slovenian: Fidaksomicin je substrat P-gp.
English: Gastrointestinal disorders vomiting, nausea, constipation abdominal distention, flatulence, dry mouth
Slovenian: Bolezni prebavil bruhanje, navzea, zaprtost napetost trebuha, flatulenca, suha usta
English: The most common side effects (may affect up to 1 in 10 people) are vomiting, nausea and constipation.
Slovenian: Najpogostejši neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) so bili bruhanje,
English: Nervous system disorders dizziness, headache, dysgeusia
Slovenian: Bolezni živčevja vrtoglavica, glavobol, disgevzija
English: DIFICLIR is indicated in adults for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) (see section 5.1).
Slovenian: difficile infections), znanih tudi kot diareja, ki jo povzroča C. difficile (CDAD-C. difficile-associated diarrhoea) (glejte poglavje 5.1).
English: The maximum fidaxomicin and OP-1118 plasma levels in CDI patients with concomitant IBD were within the range of levels found in CDI patients without IBD.
Slovenian: Največja plazemska koncentracija fidaksomicina in OP-1118 pri bolnikih s CDI s pridruženo IBD je bila primerljiva koncentraciji pri bolnikih s CDI brez IBD.
English: − If you are allergic to fidaxomicin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo DIFICLIR Ne jemljite zdravila DIFICLIR če ste alergični na fidaksomicin, ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: A main metabolite, OP-1118, is formed through hydrolysis of the isobutyryl ester.
Slovenian: Glavni presnovek, OP-1118, nastaja s hidrolizo izobutiril estra.
English: − The active substance is fidaxomicin.
Slovenian: − Zdravilna učinkovina je fidaksomicin.
English: DIFICLIR 200 mg film-coated tablets Fidaxomicin
Slovenian: DIFICLIR 200 mg filmsko obložene tablete fidaksomicin
English: Fidaxomicin should be used with caution in patients with a known macrolides allergy.
Slovenian: Pri bolnikih z znano alergijo na makrolide je potrebno fidaksomicin uporabljati previdno.
English: As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see section 4.4 and 5.2).
Slovenian: Ker klinična pomembnost tega povečanja pri izpostavljenosti ni znana, se sočasno dajanje močnih zaviralcev P-gp, kot so ciklosporin, ketokonazol, eritromicin, klaritromicin,
English: Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Zaradi omejenih kliničnih podatkov pri tej populaciji je treba zdravilo DIFICLIR uporabljati previdno pri bolnikih z zmerno do hudo okvaro jeter (glejte poglavji 4.4 in 5.2).
English: Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, and reproductive toxicity.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment (see section 5.2).
Slovenian: Zaradi omejenih kliničnih podatkov je treba fidaksomicin uporabljati previdno pri bolnikih s hudo okvaro ledvic ali z zmerno do hudo okvaro jeter (glejte poglavje 5.2).
English: The most common adverse reactions are vomiting, nausea and constipation.
Slovenian: Povzetek varnostnega profila Najpogostejši neželeni učinki, so bruhanje, navzea in zaprtost.
English: Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with severe renal impairment (see sections 4.4 and
Slovenian: Zaradi omejenih kliničnih podatkov pri tej populaciji je treba zdravilo DIFICLIR uporabljati previdno pri bolnikih s hudo okvaro ledvic (glejte poglavji 4.4 in 5.2)
English: 100 x 1 film-coated tablet in alu/alu perforated unit dose blisters.
Slovenian: 100 x 1 filmsko obložena tableta v perforiranih Al/Al pretisnih omotih.
English: Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.5 and 5.2).
Slovenian: klaritromicin, verapamil, dronedaron in amiodaron, ni priporočljivo (glejte poglavji 4.5 in 5.2).
English: 20 x 1 film-coated tablet in alu/alu perforated unit dose blisters.
Slovenian: 20 x 1 filmsko obložena tableta v perforiranih Al/Al pretisnih omotih.
English: If you use one of these medicines, please ask your doctor for advice before taking this medicine.
Slovenian: Če jemljete katero od teh zdravil, se posvetujte s svojim zdravnikom, preden vzamete zdravilo DIFICLIR.
English: What you need to know before you take DIFICLIR
Slovenian: Kaj je zdravilo DIFICLIR in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo DIFICLIR Kako jemati zdravilo DIFICLIR
English: Acute hypersensitivity reactions, such as angioedema and dyspnea, have been reported during post-marketing (see section 4.3 and 4.4).
Slovenian: Opis izbranih neželenih učinkov V obdobju trženja zdravila so poročali o akutnih preobčutljivostnih reakcijah, kot sta angioedem in dispneja (glejte poglavji 4.3 in 4.4).
English: What DIFICLIR contains
Slovenian: Kaj vsebuje zdravilo DIFICLIR
English: NAME OF THE MEDICINAL PRODUCT DIFICLIR 200 mg film-coated tablets fidaxomicin
Slovenian: IME ZDRAVILA DIFICLIR 200 mg filmsko obložene tablete
English: Fidaxomicin may be a mild to moderate inhibitor of intestinal P-gp.
Slovenian: Fidaksomicin lahko blago do zmerno zavira črevesni P-gp.
English: − clarithromycin (a medicine used to treat chest infections, throat and sinus infections, skin and tissue infections and Helicobacter pylori infections associated with duodenal or stomach ulcer)
Slovenian: - eritromicin (zdravilo, ki se uporablja za zdravljenje okužb ušesa, nosu, žrela, prsnega koša ali kože), - klaritromicin (zdravilo, ki se uporablja za zdravljenje okužb prsnega koža, žrela in sinusov, kože in tkiva ter okužb z bakterijo Helicobacter pylori, povezanih z razjedo dvanajsternika ali želodca), - verapamil (zdravilo, ki se uporablja za zdravljenje visokega krvnega tlaka ali za preprečevanje napadov bolečine v prsnem košu ali po srčnem napadu za preprečevanje naslednjega), - dronedaron in amiodaron (zdravilo, ki se uporablja za nadzor srčnega utripa), - dabigatran eteksilat (zdravilo, ki se uporablja za preprečevanje nastajanja krvnih strdkov po kirurški zamenjavi kolčnega ali kolenskega sklepa).
English: No adverse reactions for acute overdose have been reported during clinical studies or from post-marketing data.
Slovenian: Med kliničnimi študijami in v obdobju trženja zdravila niso poročali o nobenem neželenem učinku akutnega prevelikega odmerjanja.
English: If you are breastfeeding ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če dojite, se posvetujte s svojim zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: Method of administration DIFICLIR is intended for oral use.
Slovenian: Zdravilo DIFICLIR je namenjeno za peroralno uporabo.
English: There was very limited accumulation of fidaxomicin or OP-1118 in plasma following administration of 200 mg fidaxomicin every 12 hours for 10 days.
Slovenian: Po odmerku 200 mg fidaksomicina vsakih 12 ur 10 dni je bila akumulacija fidaksomicina ali OP-1118 v plazmi zelo majhna.
English: − If you get any side effects, talk to your doctor or pharmacist.
Slovenian: − Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Navodilo za uporabo DIFICLIR 200 mg filmsko obložene tablete fidaksomicin Pred začetkom jemanja natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Immune system disorders rash, pruritus hypersensitivity reactions (angioedema, dyspnea)
Slovenian: Bolezni imunskega sistema izpuščaj, pruritus preobčutljivostne reakcije
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: How to store DIFICLIR
Slovenian: Shranjevanje zdravila DIFICLIR
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Astellas Pharma Europe B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Astellas Pharma Europe B.V.
English: Do not take DIFICLIR
Slovenian: PRETISNI OMOT
English: − rash, itching (pruritus)
Slovenian: (angioedem, dispneja)
English: Astellas Pharma B.V. Tel: +31 (0)71 5455745
Slovenian: Tel: +31 (0)71 5455745
English: Astellas Pharma S.p.A. Tel: +39 02 921381
Slovenian: Tel: +39 02 921381
English: Not known side effects (frequency cannot be estimated from the available data) − swelling of the face and throat (angioedema), trouble breathing (dyspnea)
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: Under conditions of clinical use, fidaxomicin has no clinically relevant effect on the exposure of rosuvastatin, a substrate for OATP2B1 and BCRP (see section 4.5).
Slovenian: Pod pogoji za klinično uporabo, fidaksomicin nima klinično pomembnega vpliva na izpostavljenost rosuvastatinu, substratu za
English: Marketing Authorisation Holder Astellas Pharma Europe B.V. Sylviusweg 62
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Astellas Pharma Europe B.V.
English: See section 4.
Slovenian: − Navodilo shranite.
English: 18 October 2012
Slovenian: 18. oktober 2012
English: It was expected to be available as tablets (20 mg/10 mg).
Slovenian: Na voljo naj bi bilo v obliki tablet (20 mg/10 mg).
English: The company did not carry out any new studies in patients with Alzheimer's disease.
Slovenian: Družba ni izvedla nobenih novih študij z bolniki z Alzheimerjevo boleznijo.
English: In addition, the company pooled and analysed the results from the different studies together.
Slovenian: Družba je prav tako zbrala in skupno analizirala izsledke različnih študij.
English: What consequences does this refusal have for patients in clinical trials?
Slovenian: Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih?
English: Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Slovenian: Živčni prenašalci so kemične snovi v živčnem sistemu, ki omogočajo medsebojno sporazumevanje živčnih celic.
English: The effectiveness of the combination treatment was assessed by comparing the patients' performance in cognitive tests and in carrying out daily living activities.
Slovenian: Učinkovitost kombiniranega zdravljenja so ocenili s primerjanjem uspešnosti bolnikov na preskusih kognitivnih sposobnosti in pri izvajanju vsakodnevnih opravil.
English: The effects of Acrescent were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Acrescent so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The company that applied for authorisation is H. Lundbeck A/S, Denmark.
Slovenian: Zahtevo za dovoljenje za promet z zdravilom je vložila danska družba H. Lundbeck A/S.
English: The causes of Alzheimer's disease are unknown, but the associated memory loss, disorientation and behavioural symptoms are believed to be due to a disturbance of neurotransmitters in the brain.
Slovenian: Vzroki za pojav Alzheimerjeve bolezni niso znani, z njo povezana izguba spomina, izguba orientacije in vedenjski simptomi pa naj bi bili posledica motenj živčnih prenašalcev v možganih.
English: However, the CHMP considered that the treatment guidelines were not consistent across European countries and the company had not provided enough evidence to support the use of a combination tablet in these patients.
Slovenian: Ne glede na to odbor CHMP meni, da smernice za zdravljenje niso skladne v vseh evropskih državah in da družba ni zagotovila dovolj dokazov, ki bi podpirali uporabo kombiniranih tablet pri teh bolnikih.
English: On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Acrescent, intended for the treatment of moderate to moderately severe Alzheimer's disease in patients who are already taking memantine and donepezil.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je 18. oktobra 2012 sprejel negativno mnenje, s katerim priporoča zavrnitev odobritve dovoljenja za promet z zdravilom Acrescent, ki naj bi se uporabljalo za zdravljenje zmerne do zmerno hude Alzheimerjeve bolezni pri bolnikih, ki že prejemajo memantin in donepezil.
English: The company also presented information intended to show the use of memantine and donepezil in combination to treat Alzheimer's disease across the European Union, including the available guidelines for treating Alzheimer's disease in different European countries.
Slovenian: Predložila je tudi podatke, ki naj bi prikazali uporabo memantina v kombinaciji z donepezilom za zdravljenje Alzheimerjeve bolezni v Evropski uniji, vključno z razpoložljivimi smernicami za zdravljenje Alzheimerjeve bolezni v različnih evropskih državah.
English: One main study involved 404 patients with moderate to severe Alzheimer's disease who were already taking donepezil.
Slovenian: V eni od študij so sodelovali 404 bolniki z zmerno do hudo Alzheimerjevo boleznijo, ki so že prejemali donepezil.
English: The CHMP considered that the additional analyses provided by the company did not satisfy these concerns.
Slovenian: Odbor CHMP je ugotovil, da dodatne analize, ki jih je predložila družba, ne izključujejo teh zadržkov.
English: Therefore, the CHMP was of the opinion that the benefits of Acrescent did not outweigh its risks and recommended that it be refused marketing authorisation.
Slovenian: Posledično je odbor CHMP menil, da koristi zdravila Acrescent ne odtehtajo z njim povezanih tveganj, zato je priporočil zavrnitev dovoljenja za promet z zdravilom.
English: The company informed the CHMP that there are no patients currently included in clinical trials with Acrescent in the European Union.
Slovenian: Družba je odbor CHMP obvestila, da v Evropski uniji v klinična preskušanja zdravila Acrescent trenutno ni vključenih bolnikov.
English: It presented the results of seven main studies, including patients (or a subset of patients) who received memantine and donepezil together.
Slovenian: Predstavila je rezultate sedmih glavnih študij, v katerih so sodelovali bolniki (ali podskupina bolnikov), ki so prejemali hkratno zdravljenje z memantinom in donepezilom.
English: Acrescent is a medicine that contains two active substances, memantine hydrochloride and donepezil hydrochloride.
Slovenian: Acrescent je zdravilo, ki vsebuje dve zdravilni učinkovini, memantinijev hidroklorid in donepezilijev hidroklorid.
English: The effects of adding memantine to donepezil was compared with adding placebo for six months of treatment.
Slovenian: Učinke dodatka memantina k donepezilu so primerjali z dodatkom placeba v šestih mesecih zdravljenja.
English: The combination of memantine and donepezil is used in some European countries to treat patients with moderate to moderately severe Alzheimer's disease.
Slovenian: Kombinacija memantina in donepezila se v nekaterih evropskih državah uporablja za zdravljenje bolnikov z zmerno do zmerno hudo Alzheimerjevo boleznijo.