FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the user Baraclude 1 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika Baraclude 1 mg filmom obložene tablete entekavir
English: EU/1/06/343/003 30 x 1 film-coated tablet EU/1/06/343/006 90 x 1 film-coated tablet
Croatian: EU/1/06/343/003 30 x 1 filmom obložena tableta EU/1/06/343/006 90 x 1 filmom obložena tableta
English: Talk to your doctor or pharmacist before taking Baraclude if you have ever had problems with your kidneys, tell your doctor.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Baraclude.
English: The oral solution is a clear, colorless to pale yellow solution.
Croatian: Oralna otopina je bistra, bezbojna do blijedožuta otopina.
English: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (< 300 copies/ml by PCR)c
Croatian: HBV DNK nemjerljiva (< 300 kopija/ml pomoću PCR)c
English: EU/1/06/343/002 30 film-coated tablets
Croatian: EU/1/06/343/002 30 filmom obloženih tableta
English: Each ml oral solution contains 0.05 mg entecavir (as monohydrate).
Croatian: Jedan ml oralne otopine sadrži 0,05 mg entekavira (u obliku hidrata).
English: Baraclude 1 mg tablets entecavir
Croatian: Baraclude 1 mg tablete entekavir
English: Albumin levels < 2.5 g/dl occurred in < 1% of patients, amylase levels > 3 times baseline in 2%, lipase levels > 3 times baseline in 11% and platelets < 50,000/mm3 in < 1%.
Croatian: Razine albumina < 2,5 g/dl bile su prisutne u < 1% bolesnika, razine amilaze > 3 puta iznad početne vrijednosti bile su prisutna u 2%, razine lipaze > 3 puta iznad početne vrijednosti pronašle su se u 11%, a trombociti < 50 000/mm3 u < 1% bolesnika.
English: Package leaflet: Information for the user Baraclude 0.5 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika Baraclude 0,5 mg filmom obložene tablete entekavir
English: For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
Croatian: Ova se indikacija temelji, kako za kompenziranu, tako i za dekompenziranu bolest jetre, na podacima iz kliničkog ispitivanja u bolesnika s HBeAg pozitivnom i HBeAg negativnom HBV infekcijom koji prethodno nisu bili liječeni analozima nukleozida.
English: The Baraclude oral solution is recommended for patients weighing from 10 kg to 32.5 kg.Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablet.
Croatian: Za bolesnike tjelesne težine od 10 kg do 32,5 kg preporučuje se Baraclude oralna otopina.Djeca tjelesne težine od najmanje 32,6 kg mogu uzimati oralnu otopinu ili tabletu od 0,5 mg.
English: Blister pack :
Croatian: POSEBNE MJERE ČUVANJA Blister pakiranje:
English: Severe Managed with CAPD
Croatian: Teško, liječeni KAPDom
English: Some people get very serious hepatitis symptoms when they stop taking Baraclude.
Croatian: Nemojte prestati uzimati Baraclude bez savjeta liječnika Neke osobe dobiju vrlo ozbiljne simptome hepatitisa kad prestanu uzimati Baraclude.
English: Results at 48 weeks of randomised, double blind studies comparing entecavir (ETV) to lamivudine (LVD) in HBeAg positive (022) and HBeAg negative (027) patients are presented in the table.
Croatian: Iskustvo u bolesnika prethodno neliječenih analozima nukleozida s kompenziranom bolešću jetre: Rezultati u 48. tjednu randomiziranih, dvostruko slijepih ispitivanja u kojima se uspoređivao entekavir (ETV) s lamivudinom (LVD) u HBeAg pozitivnih (022) i HBeAg negativnih (027) bolesnika prikazani su u sljedećoj tablici.
English: Baraclude contains maltitol, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216) and sodium
Croatian: Baraclude sadrži maltitol, metilhidroksibenzoat (E218), propilhidroksibenzoat (E216) i natrij Ovaj lijek sadrži maltitol.
English: Blister pack: 30 x 1 film-coated tablet 90 x 1 film-coated tablet
Croatian: OBLIK I SADRŽAJ Blister pakiranje: 30 x 1 filmom obložena tableta 90 x 1 filmom obložena tableta Pakiranje u boci: 30 filmom obloženih tableta
English: In HBeAg positive paediatric patients, treatment should be administered for at least 12 months after achieving undetectable HBV DNA and HBeAg seroconversion (HBeAg loss and anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy.
Croatian: Kod HBeAg pozitivnih pedijatrijskih bolesnika liječenje treba primjenjivati najmanje 12 mjeseci nakon postizanja nemjerljivih razina HBV DNK i HBeAg serokonverzije ( nestanak HBeAg i detekcija anti-HBe protutijela u dva uzastopna uzorka seruma u razmaku od najmanje 3 do 6 mjeseci) ili do HBs serokonverzije ili do gubitka djelotvornosti.
English: HIV/HBV co-infected patients receiving concomitant antiretroviral therapy: entecavir has been studied in 68 adults with HIV/HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
Croatian: Entekavir se ispitao u 68 odraslih osoba s istodobnom infekcijom HIV-om i HBV-om koji su primali HAART koji sadrži lamivudin (vidjeti dio 5.1).
English: HBeAg negative (study 027): treatment with entecavir up to 96 weeks (n = 325) resulted in cumulative response rates of 94% for HBV DNA < 300 copies/ml by PCR and 89% for ALT normalisation versus 77% for HBV DNA < 300 copies/ml by PCR and 84% for ALT normalisation for lamivudine-treated patients (n = 313).
Croatian: HBeAg negativni (ispitivanje 027): Liječenje entekavirom u trajanju do 96 tjedana (n = 325) rezultiralo je kumulativnim stopama odgovora od 94% za HBV DNK < 300 kopija/ml mjereno PCRom i 89% za normalizaciju ALT-a, naspram kumulativne stope odgovora na liječenje lamivudinom (n = 313) od 77% za HBV DNK < 300 kopija/ml mjereno PCR-om i 84% za normalizaciju ALT-a.
English: Blister pack:
Croatian: Blisteri:
English: What BARACLUDE is and what it is used for Baraclude oral solution is an anti-viral medicine, used to treat chronic (long term) hepatitis B
Croatian: Baraclude oralna otopina je antivirusni lijek, koji se primjenjuje za liječenje kronične (dugotrajne) infekcije virusom hepatitisa B (HBV) u odraslih.
English: EU/1/06/343/001 30 film-coated tablets
Croatian: EU/1/06/343/001 30 filmom obloženih tableta
English: Baraclude 0.5 mg film-coated tablets Baraclude 1 mg film-coated tablets
Croatian: Baraclude 0,5 mg filmom obložene tablete Baraclude 1 mg filmom obložene tablete
English: n
Croatian: b.
English: Laboratory test abnormalities: through week 48 among entecavir-treated patients with decompensated liver disease, none had ALT elevations both > 10 times ULN and > 2 times baseline, and 1% of patients had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2
Croatian: Abnormalnosti laboratorijskih nalaza: Do 48. tjedna niti jedan od bolesnika liječenih entekavirom s dekompenziranom bolešću jetre nije imao povišenja ALT > 10 puta iznad GGN i > 2 puta iznad početne vrijednosti, a 1% bolesnika imao je povišenja ALT > 2 puta iznad početne vrijednosti s ukupnim bilirubinom > 2 puta iznad GGN i > 2 puta iznad početne vrijednosti.
English: What BARACLUDE is and what it is used for Baraclude tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus
Croatian: Baraclude tablete su antivirusni lijek, koji se primjenjuje za liječenje kronične (dugotrajne) infekcije virusom hepatitisa B (HBV) u odraslih.
English: Baraclude 0.5 mg tablets entecavir
Croatian: Baraclude 0,5 mg tablete entekavir
English: The oral solution should be used for patients with body weight less than 32.6 kg.
Croatian: Za bolesnike tjelesne težine manje od 32,6 kg treba primijeniti oralnu otopinu.
English: 0.05 mg once daily OR 0.5 mg every 5-7 days
Croatian: 0,05 mg jednom dnevno ILI 0,5 mg svakih 5-7 dana
English: The Cmax, AUC(024), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng∙h/ml, and 0.28 ng/ml, respectively.
Croatian: U tih je ispitanika Cmax iznosio 6,31 ng/ml, AUC(0-24) 18,33 ng∙h/ml, a Cmin 0,28 ng/ml.
English: Each film-coated tablet contains 0.5 mg entecavir.
Croatian: Jedna filmom obložena tableta sadrži 0,5 mg entekavira.
English: Crospovidone
Croatian: Entekavir
English: Titanium dioxide Hypromellose Macrogol 400
Croatian: Ovojnica tablete: titanijev dioksid hipromeloza makrogol 400 željezov oksid, crveni
English: The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults.
Croatian: Nuspojave primijećene u pedijatrijskih ispitanika koji su primili liječenje entekavirom bile su sukladne onima primijećenima u kliničkim ispitivanjima entekavira u odraslih (vidjeti Sažetak profila sigurnosti i dio 5.1).
English: d ≥1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
Croatian: d Povećanje od ≥ 1 log10 iznad najniže točke HBV DNK mjerene PCR-om, što je bilo potvrđeno uzastopnim mjerenjima ili na kraju specificirane vremenske točke. e ETVr u bilo kojoj godini, virološki proboj u određenoj godini.
English: Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG Plaza 254
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet: Bristol-Myers Squibb Pharma EEIG Plaza 254
English: HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Croatian: HBeAg pozitivni (ispitivanje 022): kumulativne stope odgovora na liječenje entekavirom u trajanju do 96 tjedana (n = 354) bile su 80% za HBV DNK < 300 kopija/ml mjereno PCR-om, 87% za normalizaciju ALT, 31% za HBeAg serokonverziju i 2% za HBsAg serokonverziju (5% za nestanak HBsAg).
English: Each film-coated tablet contains 1 mg entecavir.
Croatian: Jedna filmom obložena tableta sadrži 1 mg entekavira.
English: Each ml of oral solution contains 0.05 mg entecavir.
Croatian: Jedan ml oralne otopine sadrži 0,05 mg entekavira.
English: Bottle pack:
Croatian: Pakiranje u boci:
English: Baseline Creatinine Clearance (ml/min) Unimpaired
Croatian: Klirens kreatinina na početku ispitivanja (ml/min) Neošteće n
English: Baraclude 1 mg film-coated tablets entecavir
Croatian: Baraclude 1 mg filmom obložene tablete entekavir
English: Package leaflet: Information for the user Baraclude 0.05 mg/ml oral solution
Croatian: Uputa o lijeku: Informacije za korisnika Baraclude 0,05 mg/ml oralna otopina entekavir
English: Baraclude dosage
Croatian: Doza lijeka Baraclude
English: Baraclude 0.5 mg film-coated tablets
Croatian: Baraclude 0,5 mg filmom obložene tablete
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)c
Croatian: Srednja vrijednost promjene od početne vrijednosti (log10 kopija/ml)c
English: 0.3 mg once daily OR 0.5 mg every 48 hours
Croatian: 0,3 mg jednom dnevno ILI 0,5 mg svakih 48 sati
English: Baraclude 1 mg film-coated tablets Tablet core:
Croatian: Baraclude 1 mg filmom obložene tablete Blister pakiranje:
English: 0.25 mg once daily OR 0.5 mg every 48 hours
Croatian: 0,25 mg jednom dnevno ILI 0,5 mg svakih 48 sati
English: 0.15 mg once daily OR 0.5 mg every 72 hours
Croatian: 0,15 mg jednom dnevno ILI 0,5 mg svaka 72 sata
English: Lactose monohydrate Magnesium stearate Cellulose, Microcrystalline Povidone
Croatian: Baraclude 1 mg filmom obložene tablete Jezgra tablete: krospovidon laktoza hidrat magnezijev stearat celuloza, mikrokristalična povidon
English: 0.1 mg once daily OR 0.5 mg every 72 hours
Croatian: 0,1 mg jednom dnevno ILI 0,5 mg svaka 72 sata
English: Baraclude 0.05 mg/ml oral solution entecavir
Croatian: Baraclude 0,05 mg/ml oralna otopina entekavir
English: Each ml contains 0.05 mg entecavir.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml sadrži 0,05 mg entekavira.
English: The oral solution should be used for patients with body weight less than 32.6 kg. Paediatric patients with body weight at least 32.6 kg, should be administered 10 ml (0.5 mg) of the oral solution or one 0.5 mg tablet once daily.
Croatian: Pedijatrijskim bolesnicima tjelesne težine od najmanje 32,6 kg treba primijeniti 10 ml (0,5 mg) oralne otopine ili jednu tabletu od 0,5 mg jednom dnevno.
English: Baseline HBV
Croatian: Nestanak HBsAgb
English: {MM/YYYY}
Croatian: Umjere no
English: Baraclude 0.5 mg film-coated tablets Blister packs: EU/1/06/343/003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/06/343/005
English: Oral solution Clear, colourless to pale yellow solution
Croatian: Bistra, bezbojna do blijedožuta otopina
English: Dosing for nucleoside naive paediatric patients aged 2 to < 18 years
Croatian: Doziranje za pedijatrijske bolesnike u dobi od 2 to < 18 godina koji prethodno nisu bili liječeni analozima nukleozida
English: Bristol-Myers Squibb S.r.l.
Croatian: Bristol-Myers Squibb B.V.
English: Baraclude 0.5 mg film-coated tablets entecavir
Croatian: Baraclude 0,5 mg filmom obložene tablete entekavir
English: Baraclude 0.05 mg/ml oral solution
Croatian: NAZIV LIJEKA Baraclude 0,05 mg/ml oralna otopina
English: if you have previously received treatment for chronic hepatits B, please inform your doctor.
Croatian: Ako ste ikad prije imali tegobe s bubrezima, recite to svom liječniku.
English: If you take more Baraclude than you should
Croatian: Ako uzmete više lijeka Baraclude nego što ste trebali Odmah se javite liječniku.
English: (in HBeAg negative patients).
Croatian: Opis odabranih nuspojava).
English: Bristol-Myers Squibb Kft. Tel: +371 67708347
Croatian: Bristol-Myers Squibb spol. s r.o. TEL: +385 1 2078 508
English: NA
Croatian: e.
English: Moderate
Croatian: OBLIK
English: Bristol-Myers Squibb Pharma EEIG
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bristol-Myers Squibb Pharma EEIG
English: From Week 4 on (day 22-28):
Croatian: Od 4. tjedna nadalje (22. - 28. dan):
English: EL-69300 Rodopi Greece
Croatian: EL-69300 Rodopi
English: You may experience increased symptoms as described in section 4 “Possible side effects”.
Croatian: Mogli bi Vam se javiti izraženiji simptomi opisani u dijelu 4 „Moguće nuspojave“.
English: 2Isolated cases reported in post-marketing experience.
Croatian: 2 Izolirani slučajevi prijavljeni u postmarketinškom iskustvu.
English: The score line is not intended for breaking the tablet.
Croatian: Razdjelna crta nije namijenjena za lomljenje tablete.
English: The volume of distribution is around 10 L/kg.
Croatian: Volumen raspodjele je oko 10 L/kg.
English: Memantine LEK with food and drink
Croatian: Memantin LEK s hranom i pićem
English: Continue to take Memantine LEK as long as it is of benefit to you.
Croatian: Nastavite uzimati Memantine LEK onoliko dugo koliko od njega imate koristi.
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.
Croatian: Ako uzmete više Memantine LEK nego što ste trebali - općenito, uzimanje previše Memantine LEK ne bi Vam trebalo naškoditi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013
Croatian: Datum prvog odobrenja: 22. travanj 2013.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate,ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: If you go into hospital, let your doctor know that you are taking Memantine LEK.
Croatian: Ako dođete u bolnicu, obavijestite svog liječnika da uzimate Memantine LEK.
English: The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows:
Croatian: Preporučena početna doza je 5 mg dnevno, koja se postupno povećava tijekom prva 4 tjedna liječenja, a doseže preporučenu dozu održavanja kako slijedi:
English: How to store Memantine LEK Contents of the pack and other information
Croatian: Kako čuvati Memantine LEK Sadržaj pakiranja i druge informacije
English: Pharmacotherapeutic group: Psychoanaleptics; Other Anti-dementia drugs, ATC code: N06DX01.
Croatian: Farmakoterapijska skupina: psihoanaleptici; ostali lijekovi protiv demencije, ATK oznaka: N06DX01.
English: Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse events of memantine were noted on fertility.
Croatian: Memantin nije bio teratogen kod štakora i kunića, čak ni kod maternalno toksičnih doza, a nisu zamijećeni niti štetni događaji memantina na plodnost.
English: In particular, Memantine LEK may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Croatian: Posebice, Memantine LEK može promijeniti učinak sljedećih lijekova te će liječnik možda morati prilagoditi njihovu dozu:
English: In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Croatian: U slučaju znakova i simptoma općenite pretjerane stimulacije središnjeg živčanog sustava (SŽS) treba razmotriti pažljivo simptomatsko kliničko liječenje.
English: 1Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Croatian: 1 Halucinacije su opažene uglavnom kod bolesnika s teškom Alzheimerovom bolešću.
English: - If you take a large overdose of Memantine LEK, contact your doctor or get medical advice, as you may need medical attention.
Croatian: Ako ste uzeli preveliku dozu Memantine LEK, javite se Vašem liječniku za savjet jer bi Vam mogla zatrebati medicinska pomoć.
English: You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Croatian: Ako ste nedavno promijenili, ili namjeravate značajno promijeniti svoj način prehrane (npr. s normalne prehrane na strogu vegetarijansku prehranu), ili ako bolujete od stanja renalne tubularne acidoze (RTA - izrazito povećana količina tvari koje tvore kiseline u krvi zbog poremećaja rada bubrega (slaba funkcija bubrega)) ili teških infekcija mokraćnog trakta (struktura kroz koje prolazi mokraća), trebali biste obavijestiti svog liječnika jer će Vam liječnik možda morati prilagoditi dozu lijeka.
English: Other medicines and Memantine LEK
Croatian: Drugi lijekovi i Memantine LEK
English: • 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).
Croatian: • ako u anamnezi imate epileptičke napadaje • ako ste nedavno imali infarkt miokarda (srčani udar) ili ako bolujete od kongestivnog zatajenja srca ili nekontrolirane hipertenzije (povišeni krvni tlak).
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.
Croatian: • Ostale djelatne tvari poput cimetidina, ranitidina, prokainamida, kinidina, kinina i nikotina koje koriste isti sustav bubrežnog kationskog transporta kao i amantadin mogle bi također stupiti u interakciju s memantinom i dovesti do potencijalnog rizika povišenja njegove koncentracije u plazmi.
English: Both active substances are chemically related NMDA-antagonists.
Croatian: Oba spoja su kemijski srodni NMDA-antagonisti.
English: 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:
Croatian: Radi smanjenja rizika od nuspojava, doza održavanja se postiže titracijom povećavanjem doze od 5 mg tjedno tijekom prva 3 tjedna na sljedeći način:
English: If you forget to take Memantine LEK - If you find you have forgotten to take your dose of Memantine LEK, wait and take your next dose at the usual time.
Croatian: - Ako ustanovite da ste zaboravili uzeti dozu Memantine LEK, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: Children and adolescents Memantine LEK is not recommended for children and adolescents under the age of 18 years.
Croatian: Memantine LEK se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: What you need to know before you take Memantine LEK
Croatian: Što morate znati prije nego počnete uzimati Memantine LEK
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ ili „EXP“.
English: Dose in patients with impaired kidney function
Croatian: Doziranje kod bolesnika s oštećenom funkcijom bubrega
English: Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin-containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Croatian: Memantin nije in vitro inhibirao CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monooksigenazu koja sadržava flavin, epoksid hidrolazu niti sulfaciju.
English: Memantine LEK belongs to a group of medicines known as anti-dementia medicines.
Croatian: Memantine LEK se ubraja u skupinu lijekova poznatih kao lijekovi protiv demencije.
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Croatian: U najekstremnijem slučaju predoziranja, bolesnik je preživio peroralno uzimanje ukupne količine od 2000 mg memantina s učincima na središnji živčani sustav (koma tijekom 10 dana, a nakon toga diplopija i agitacija).
English: What is Memantine LEK used for Memantine LEK is used for the treatment of adult patients with moderate to severe Alzheimer's disease.
Croatian: Za što se Memantine LEK koristi Memantine LEK se koristi za liječenje odraslih bolesnika s umjerenom do teškom Alzheimerovom bolešću.
English: Memantine LEK should be administered once a day and should be taken at the same time every day.
Croatian: Memantine LEK treba primjenjivati jedanput na dan i potrebno ga je uzimati svaki dan u isto vrijeme.
English: Elevated liver function test Hepatitis
Croatian: Često povišeni rezultat testa jetrene funkcije
English: Also, Memantine LEK may change your reactivity, making driving or operating machinery inappropriate.
Croatian: Memantine LEK također može promijeniti Vašu sposobnost reagiranja, što čini upravljanje vozilima i rad na strojevima neprikladnima.
English: Verovškova 57, 1526 Ljubljana Slovenia
Croatian: Lek Pharmaceuticals d.d. Verovškova 57, 1526 Ljubljana Slovenija
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.
Croatian: Primjena lijeka Memantine LEK kod djece i adolescenata mlađih od 18 godina se ne preporučuje zbog nedostatka podataka o sigurnosti i djelotvornosti.
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.
Croatian: U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja lijeka Memantine LEK.
English: 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.
Croatian: Dnevne doze od 20 mg dovode do plazmatskih koncentracija memantina u stanju dinamičke ravnoteže u rasponu od 70 do 150 ng/mL (0,5 - 1 µmol) s velikim interindividualnim razlikama.