FrancophonIA/ELRC3.0 huggingface dataset:
English: The dosing pump should be locked after use.
Croatian: Pumpicu za doziranje treba zaključati nakon uporabe.
English: Once opened, the contents of the bottle should be used within 3 months.
Croatian: Jednom kad se otvori, sadržaj boce treba upotrijebiti unutar 3 mjeseca.
English: None of these metabolites exhibit NMDA-antagonistic activity.
Croatian: Nijedan od navedenih metabolita ne pokazuje NMDA-antagonističku aktivnost.
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.
Croatian: Nije poznato izlučuje li se memantin u majčino mlijeko ljudi, no, uzimajući u obzir lipofilnost tvari, do toga vjerojatno dolazi.
English: Once daily
Croatian: Jedanput dnevno
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.
Croatian: Sve je više dokaza da slabo funkcioniranje glutamatergične neurotransmisije, posebice na NMDA-receptorima, doprinosi izraženosti simptoma i progresiji bolesti kod neurodegenerativne demencije.
English: Memantine should not be used during pregnancy unless clearly necessary.
Croatian: Memantin se ne smije primjenjivati tijekom trudnoće, osim ako to nije izričito potrebno.
English: 1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
Croatian: 1 Halucinacije su opažene uglavnom kod bolesnika s teškom Alzheimerovom bolešću.
English: Both compounds are chemically related NMDA-antagonists.
Croatian: Oba spoja su kemijski srodni NMDA-antagonisti.
English: Psychotic reactions2
Croatian: Nepoznato psihotične reakcije2
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.
Croatian: Budući da učinci nisu bili primijećeni u dugoročnim ispitivanjima na glodavcima i neglodavcima, klinički značaj ovih nalaza nije poznat.
English: For detailed instructions on the preparation and handling of the product see end of this leaflet.
Croatian: Za detaljne upute o pripremi i postupanju s lijekom, vidjeti kraj ove upute.
English: In particular, Memantine Merz may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Croatian: Posebice, Memantine Merz može promijeniti učinak sljedećih lijekova, te će liječnik možda morati prilagoditi njihovu dozu:
English: Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient.
Croatian: Terapiju treba započeti samo ako je dostupan njegovatelj koji će redovito nadzirati bolesnikovo uzimanje lijeka.
English: This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.
Croatian: Ova doza će se povećavati za 5 mg tjedno dok se ne postigne preporučena doza (doza održavanja).
English: In short term studies in rats memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations.
Croatian: U kratkoročnim ispitivanjima na štakorima, memantin je, kao i drugi NMDA-antagonisti, uzrokovao neuronsku vakuolizaciju i nekrozu (Olney lezije) samo nakon doza koje su dovodile do vrlo visokih vršnih serumskih koncentracija.
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.
Croatian: Ako se lijek dobro podnosi tijekom razdoblja liječenja od najmanje 7 dana, doza se može povećati do 20 mg/dan prema standardnoj shemi titriranja.
English: Diagnosis should be made according to current guidelines.
Croatian: Dijagnozu treba postaviti prema važećim smjernicama.
English: Week 2 (day 8-14):
Croatian: 2. tjedan (8. - 14. dan):
English: Date of first authorisation: 22 Nov 2012 Date of latest renewal: {DD month YYYY}
Croatian: Datum prvog odobrenja: 22 studeni 2012.
English: If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Croatian: Ako imate oštećenu funkciju bubrega, liječnik će odlučiti o dozi koja odgovara Vašem stanju.
English: Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Croatian: Također, pH mokraće može biti povišen stanjima renalne tubularne acidoze (RTA) ili teških infekcija mokraćnog trakta uzrokovanih bakterijama vrste Proteus.
English: The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Croatian: Mozak sadržava takozvane N-metil-D-aspartat (NMDA) receptore koji su uključeni u prijenos živčanih signala važnih u učenju i pamćenju.
English: Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially potassium-free.
Croatian: Nadalje, ovaj lijek sadržava kalij, manje od 1 mmol (39 mg) po dozi, tj. u osnovi ne sadržava kalij.
English: Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Croatian: Preporučuje se oprez kod bolesnika s epilepsijom, konvulzijama u anamnezi ili bolesnicima s predisponirajućim čimbenicima za pojavu epilepsije.
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 opće pretjerane stimulacije središnjeg živčanog sustava (SŽS), treba razmotriti pažljivo simptomatsko kliničko liječenje.
English: There is no indication that food influences the absorption of memantine.
Croatian: Nema pokazatelja da hrana utječe na apsorpciju memantina.
English: One tablet daily
Croatian: Jedna tableta dnevno
English: The patient received symptomatic treatment and plasmapheresis.
Croatian: Bolesnik je liječen simptomatski i plazmaferezom.
English: The patient recovered without permanent sequelae.
Croatian: Bolesnik se oporavio bez trajnih sekvela.
English: - In general, taking too much Memantine Merz should not result in any harm to you.
Croatian: - Općenito, uzimanje previše Memantine Merza ne bi Vam trebalo naškoditi.
English: This medicinal product contains sorbitol.
Croatian: Ovaj lijek sadržava sorbitol.
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.
Croatian: Nakon toga, klinička korist memantina i podnošljivost liječenja trebaju biti redovito ponovno procjenjivane u skladu s kliničkim smjernicama.
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).
Croatian: Ispitivanja na životinjama upućuju na postojanje mogućnosti smanjenja intrauterinog rasta pri izloženosti dozama istim ili nešto višim nego kod ljudi (vidjeti dio 5.3).
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).
Croatian: 50 ml (i 10 x 50 ml) u smeđim staklenim bočicama (hidrolitička skupina II) i 100 ml u smeđim staklenim bočicama (hidrolitička skupina III).
English: Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but not in monkeys.
Croatian: Očne promjene su nedosljedno zabilježene u ispitivanjima toksičnosti ponovljenih doza kod glodavaca i pasa, ali ne i kod majmuna.
English: There was no evidence of any carcinogenicity in life long studies in mice and rats.
Croatian: Nije bilo dokaza ni o kakvoj kancerogenosti u ispitivanjima tijekom životnih ciklusa miševa i štakora.
English: Push down the dosing pump head in a firm but calm and steady manner - not too slowly (fig. 7, fig. 8).
Croatian: Pritisnite vrh pumpice za doziranje snažno, ali smireno i mirno - ne presporo (sl. 7, sl. 8).
English: Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse effects 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 učinci memantina na plodnost.
English: Slide the plastic dip tube carefully into the bottle.
Croatian: Pažljivo umetnite plastičnu tubu u bocu.
English: Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Croatian: Alzheimerova bolest povezuje se s depresijom, samoubilačkim mislima i samoubojstvom.
English: • In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Croatian: • U postmarketinškom iskustvu zabilježeni su izolirani slučajevi povišenja međunarodno ujednačenog omjera (INR-a) kod bolesnika koji su istodobno liječeni varfarinom.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja ovog lijeka.
English: Blister packs containing 14 film-coated tablets per PVDC/PE/PVC/Al-blister or PP/Al-blister strip.
Croatian: Pakiranja s blisterima sadržavaju 14 filmom obloženih tableta po PVDC/PE/PVC/Al-blisteru ili PP/Al-blisteru.
English: The solution must not be poured or pumped directly into the mouth from the bottle or pump.
Croatian: Otopina se ne smije uliti ili uštrcati izravno u usta iz boce ili pumpice.
English: Memantine Merz is not recommended for children and adolescents under the age of 18 years.
Croatian: Merz se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: Specific ophthalmoscopic examinations in clinical studies with memantine did not disclose any ocular changes.
Croatian: Specifični oftalmoskopski pregledi u kliničkim ispitivanjima memantina nisu otkrili nikakve promjene na očima.
English: In another case of a large overdose, the patient also survived and recovered.
Croatian: U drugom slučaju predoziranja velikom dozom, bolesnik je također preživio te se oporavio.
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.
Croatian: Relativno velika predoziranja (200 mg, odnosno, 105 mg/dan tijekom 3 dana) povezana su ili samo sa simptomima umora, slabosti i/ili proljeva, ili su bez simptoma.
English: Ataxia and other preclinical signs have preceded the vacuolisation and necrosis.
Croatian: Ataksija i drugi neklinički znakovi prethodili su vakuolizaciji i nekrozi.
English: For detailed instructions on the preparation and handling of the product see section 6.6.
Croatian: Za detaljne upute o pripremi i rukovanju lijekom, vidjeti dio 6.6.
English: The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine Merz dose during the first 3 weeks of treatment.
Croatian: Preporučena doza za liječenje od 20 mg dnevno postiže se postupnim povećanjem doze Memantine Merza tijekom prva 3 tjedna liječenja.
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Croatian: Liječenje treba započeti i nadzirati liječnik koji ima iskustva u dijagnosticiranju i liječenju
English: Continue to take Memantine Merz as long as it is of benefit to you.
Croatian: Nastavite uzimati Memantine Merz onoliko dugo koliko od nje imate koristi.
English: You may experience increased symptoms as described in section 4.
Croatian: Mogli bi Vam se javiti izraženiji simptomi opisani u dijelu 4. «Moguće nuspojave».
English: Multipack 500 ml, comprising 10 packs, each containing 1 bottle with 50 ml oral solution.
Croatian: Višestruko pakiranje od 500 ml koje uključuje 10 pakiranja od kojih svako sadrži 1 bocu s 50 ml oralne otopine.
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: Please 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 ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Memantine Merz oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml).
Croatian: Memantine Merz oralna otopina dostupna je u bocama od 50 ml, 100 ml ili višestruko pakiranje od 500 ml (10 x 50 ml).
English: Talk to your doctor or pharmacist before taking Memantine Merz - 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).
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Memantine Merz - 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: Prior to first use the dosing pump has to be screwed on the bottle.
Croatian: Prije prve uporabe pumpicu za doziranje treba pričvrstiti zavrtanjem na bocu.
English: EU/1/12/799/028 500 ml (10 bottles of 50 ml)
Croatian: EU/1/12/799/028 500 ml (10 boca od 50 ml)
English: In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Croatian: Iz većine kliničkih ispitivanja bili su isključeni bolesnici koji su nedavno imali infarkt miokarda, bolesnici s nekompenziranim kongestivnim zatajenjem srca (NYHA III-IV) ili nekontroliranom hipertenzijom.
English: For continuation of the treatment please consult your doctor.
Croatian: Za nastavak liječenja posavjetujte se sa svojim liječnikom.
English: Content of the pack and other information What Memantine Merz contains
Croatian: SADRŽAJ PAKIRANJA I DRUGE INFORMACIJE Što Memantine Merz sadrži
English: If you go into hospital, let your doctor know that you are taking Memantine Merz.
Croatian: Ako dođete u bolnicu, obavijestite svog liječnika da uzimate Memantine Merz.
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Croatian: Metaanaliza bolesnika s umjerenom do teškom Alzheimerovom bolešću (ukupni MMSE <20) iz šest faza III placebom kontroliranih ispitivanja u trajanju od 6 mjeseci (uključujući monoterapijska ispitivanja i ispitivanja s bolesnicima na stabilnoj dozi inhibitora acetilkolinesteraze) pokazala je da postoji statistički značajan učinak u korist liječenja memantinom u kognitivnom, globalnom i funkcionalnom području.
English: The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Croatian: Preporučena doza održavanja je 20 mg jednom dnevno, te se postiže na početku 4. tjedna.
English: - If you take a large overdose of Memantine Merz, contact your doctor or get medical advice, as you may need medical attention.
Croatian: Ako ste uzeli preveliku dozu Memantine Merza, javite se Vašem liječniku za savjet, jer bi Vam mogla zatrebati medicinska pomoć.
English: CARTON AND LABEL FOR BOTTLE
Croatian: KUTIJA I NAJEPNICA ZA BOCU
English: Hold a glass with a little water or a spoon below the nozzle.
Croatian: Ispod mlaznice stavite čašu s malo vode ili žlicu.
English: Take the dosing pump out of the plastic bag (fig. 2) and place it on top of the bottle.
Croatian: Izvadite pumpicu za doziranje iz plastične vrećice (sl. 2) i postavite ju na vrh boce.
English: The film-coated tablets can be taken with or without food.
Croatian: Filmom obložene tablete mogu se uzimati sa ili bez hrane.
English: The dosing pump is then ready for use.
Croatian: Pumpica za doziranje tada je spremna za uporabu.
English: In general, the observed side effects are mild to moderate.
Croatian: Općenito, opažene nuspojave su blage do umjerene.
English: For up-titration other tablet strengths are available.
Croatian: Za povećanje doze lijeka dostupne su i tablete drugih jačina.
English: Dosage in patients with impaired kidney function
Croatian: Doziranje kod bolesnika s oštećenom funkcijom bubrega
English: Memantine Merz is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Croatian: Primjena Memantine Merza kod djece mlađe od 18 godina se ne preporučuje zbog nedostatka podataka o sigurnosti i djelotvornosti.
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, te doseže preporučenu dozu održavanja na sljedeći način:
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).
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: Treatment of patients with moderate to severe Alzheimer's disease.
Croatian: Liječenje bolesnika s umjerenom do teškom Alzheimerovom bolešću.
English: The tablets can be taken with or without food.
Croatian: Tablete se mogu uzimati sa ili bez hrane.
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.
Croatian: • Način djelovanja sugerira da bi učinci L-dope, dopaminergičkih agonista i antikolinergika mogli biti pojačani pri istodobnom liječenju NMDA-antagonistima poput memantina.
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).
Croatian: Da bi se to učinilo, vrh pumpice za doziranje treba okrenuti u smjeru strelice za oko jednu osminu okretaja, dok se ne osjeti otpor (sl. 4).
English: Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
Croatian: Istodobna primjena memantina sa spazmoliticima, dantrolenom ili baklofenom može promijeniti njihov učinak te će možda biti potrebna prilagodba doze.
English: The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Croatian: Bolesnik je imao simptome središnjeg živčanog sustava poput nemira, psihoze, vizualnih halucinacija, prokonvulzivnosti, somnolencije, stupora i besvjesnog stanja.
English: Oral solution 50 ml
Croatian: Oralna otopina 50 ml
English: The bottle with the mounted pump may only be kept and transported in a vertical position.
Croatian: Boca s namještenom pumpicom može se čuvati i prenositi samo u vertikalnom položaju.
English: Memantine Merz contains sorbitol
Croatian: Memantine Merz sadrži sorbitol
English: Also, Memantine Merz may change your reactivity, making driving or operating machinery inappropriate.
Croatian: Memantine Merz također može promijeniti Vašu sposobnost reagiranja, što čini upravljanje vozilima i rad sa strojevima neprikladnima.
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: The solution is clear and colourless to light yellowish.
Croatian: Otopina je bistra i bezbojna do svijetlo žućkasta.
English: The solution can be taken with or without food.
Croatian: Otopina se može uzimati sa ili bez hrane.
English: Memantine Merz acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Croatian: Memantine Merz djeluje na navedene NMDA receptore poboljšavajući prijenos živčanih signala i pamćenje.
English: The dosing pump head should not be pushed down while in the locked position.
Croatian: Vrh pumpice za doziranje se ne smije gurati prema dolje dok je u zaključanom položaju.
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.
Croatian: Otopinu se ne smije uliti ili uštrcati u usta izravno iz boce ili pumpice, već treba biti dozirana u žlicu ili u čašu vode korištenjem pumpice.
English: The dosing pump has to be removed from the plastic bag (fig. 2) and placed on top of the bottle, sliding the plastic dip tube carefully into the bottle.
Croatian: Pumpicu za doziranje treba izvaditi iz plastične vrećice (sl. 2) i postaviti na vrh boce kližući plastičnu tubu pažljivo u bocu.
English: Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine.
Croatian: Terapija održavanja može se nastaviti dok god postoji terapijska korist i dok bolesnik dobro podnosi liječenje memantinom.
English: If you take more Memantine Merz than you should
Croatian: Ako uzmete više Memantine Merz nego što ste trebali
English: The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (fig. 6).
Croatian: Sljedeći put kada se vrh pumpice za doziranje potpuno pritisne prema dolje (odgovara jednom potisku pumpice), raspršit će se ispravna doza (sl. 6).
English: Mounting the dosing pump on the bottle:
Croatian: Namještanje pumpice za doziranje na bocu:
English: 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.
Croatian: Trebalo bi izbjegavati istodobnu primjenu lijekova koji se zovu amantadin (za liječenje Parkinsonove bolesti), ketamin (tvar koja se obično koristi kao anestetik), dekstrometorfan (obično se koristi za liječenje kašlja) i ostalih antagonista NMDA.
English: Place the bottle on a flat, horizontal surface, for example a table top, and only use it in a upright position.
Croatian: Bocu treba staviti na ravnu, horizontalnu površinu, na primjer na površinu stola i smije se koristiti samo u vertikalnom položaju.
English: Blister packs containing either 7, 10, 14 or 20 tablets per blister strip (Alu/PP).
Croatian: Pakiranja s blisterima sadržavaju 7, 10, 14 ili 20 tableta po blisteru (Al/PP).
English: Excipients: Each one millilitre of solution contains 100 mg sorbitol (E 420) and 0.5 mg potassium, see section 4.4.
Croatian: Pomoćne tvari: svaki mililitar otopine sadrži 100 mg sorbitola (E420) i 0,5 mg kalija, vidjeti dio 4.4.
English: The patient had received 400 mg memantine orally.
Croatian: Bolesnik je peroralno uzeo 400 mg memantina.