FrancophonIA/ELRC3.0 huggingface dataset:
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki= inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Croatian: Pri dozi od 20 mg memantina dnevno, razine u CSL-u odgovaraju ki-vrijednosti (ki = konstanta inhibicije) memantina, koja u frontalnom korteksu kod ljudi iznosi 0,5 µmol.
English: These active substances act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
Croatian: Ovi spojevi djeluju na isti sustav receptora kao i memantin, te bi nuspojave (uglavnom povezane sa središnjim živčanim sustavom (SŽS)) mogle biti učestalije ili izraženije (vidjeti također dio 4.5).
English: Furthermore, Memantine LEK has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Croatian: Nadalje, Memantine LEK ima blagi ili umjereni utjecaj na sposobnost upravljanja vozilima i rada na strojevima, pa ambulantne bolesnike treba upozoriti da na to obrate posebnu pozornost.
English: • if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Memantine LEK • ako ste alergični na memantinklorid ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: What Memantine LEK is and what it is used for What you need to know before you take Memantine LEK How to take Memantine LEK Possible side effects
Croatian: Što je Memantine LEK i za što se koristi Što morate znati prije nego počnete uzimati Memantine LEK Kako uzimati Memantine LEK
English: The recommended dose of Memantine LEK for adults and elderly patients is 20 mg once a day.
Croatian: Preporučena doza lijeka Memantin LEK za odrasle i starije bolesnike je 20 mg jedanput na dan.
English: Adults
Croatian: Odrasli:
English: 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.
Croatian: Glavni metaboliti kod ljudi su N-3,5-dimetil-gludantan, izomerna mješavina 4- i 6-hidroksi-memantina i 1-nitrozo-3,5dimetil-adamantan.
English: (≥1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: 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.
Croatian: U farmakokinetičkim ispitivanjima (PK) u kojima su primijenjene pojedinačne doze kod mladih zdravih ispitanika nije uočena značajna interakcija djelatna tvar-djelatna tvar između memantina i gliburida/metformina ili donepezila.
English: Memantine LEK acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Croatian: Memantine LEK djeluje na navedene NMDA receptore poboljšavajući prijenos živčanih signala i pamćenje.
English: What Memantine LEK contains
Croatian: Što Memantine LEK sadrži
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 mL/min) daily dose should be 10 mg per day.
Croatian: Kod bolesnika s umjerenim oštećenjem bubrega (klirens kreatinina 30-49 mL/min) dnevna doza bi trebala biti 10 mg na dan.
English: Concomitant administration of memantine with the antispasmodic medicinal products, 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: This is increased to one tablet of 10 mg once a day (1x 10 mg) in the second week and to 1 and a half tablet of 10 mg once a day in the third week.
Croatian: Ova doza se povećava na jednu tabletu od 10 mg jedanput na dan (1 x 10 mg) u drugom tjednu te na jednu i pol tabletu od 10 mg jedanput na dan u trećem tjednu.
English: The usual starting dose is half a tablet of 10 mg once a day (1x 5 mg) for the first week.
Croatian: Uobičajena početna doza iznosi pola tablete od 10 mg jedanput na dan (1 x 5 mg) tijekom prvog tjedna.
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20
Croatian: U ispitivanju u kojem je korišten oralno primijenjen 14C-memantin, uklonjeno je prosječno 84% doze unutar 20 dana, više od 99% izlučeno je putem bubrega.
English: In volunteers with normal kidney function, total clearance (Cltot) amounts to 170 mL/min/1.73 m² and part of total renal clearance is achieved by tubular secretion.
Croatian: Kod dobrovoljaca s normalnom funkcijom bubrega ukupni klirens (Cltot) iznosi do 170 ml/min/1,73 m², a dio se ukupnog bubrežnog klirensa postiže tubularnom sekrecijom.
English: 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Croatian: 28 filmom obloženih tableta 30 filmom obloženih tableta 42 filmom obložene tablete 56 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta
English: 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Croatian: 28 filmom obloženih tableta 30 filmom obloženih tableta 42 filmom obložene tablete 50 filmom obloženih tableta 56 filmom obloženih tableta 60 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta 112 filmom obloženih tableta
English: In patients with mildly impaired renal function (creatinine clearance 50 - 80 mL/min) no dose adjustment is required.
Croatian: Kod bolesnika s blagim oštećenjem funkcije bubrega (klirens kreatinina 50-80 mL/min) nije potrebna prilagodba doze.
English: 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).
Croatian: U 6. mjesecu ispitivanja pokazani su povoljni učinci liječenja memantinom u usporedbi s placebom (analiza opaženih slučajeva za promjene bazirane na dojmu kliničara nakon intervjua (CIBIC-plus): p=0,025; kooperativno ispitivanje Alzheimerove bolesti - aktivnosti svakodnevnog života (ADCS-ADLsev): p=0,003; skup znakova teške onesposobljenosti (SIB): p=0,002).
English: Memantine LEK should be administered orally once a day.
Croatian: Memantine LEK treba primjenjivati kroz usta jedanput na dan.
English: 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).
Croatian: Kada je ustanovljeno istodobno pogoršanje stanja bolesnika u sva tri područja, rezultati su pokazali statistički značajan učinak memantina u sprječavanju pogoršanja, u skupini bolesnika liječenih placebom bilo je dvostruko više pogoršanja u sva tri područja nego u skupini bolesnika liječenih memantinom (21% naspram 11%, p<0,0001).
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets or one 20 mg tablet once a day
Croatian: 4. tjedan i nadalje dvije tablete od 10 mg ili jedna tableta od 20 mg jedanput na dan
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IFAPPROPRIATE
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
English: What Memantine LEK looks like and contents of the pack Memantine LEK 10 mg film-coated tablets are presented as yellow, oval film-coated tablet scored in one side.
Croatian: Kako Memantine LEK izgleda i sadržaj pakiranja Memantine LEK 10 mg filmom obložene tablete su žute boje, ovalnog oblika, urezane na jednoj strani.
English: Common (may affect up to 1 in 10 people):
Croatian: Česte (mogu se javiti kod 1 na 10 osoba):
English: The recommended maintenance dose is 20 mg per day.
Croatian: Preporučena doza održavanja je 20 mg dnevno.
English: Tablet core: croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate
Croatian: Jezgra tablete: umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid, mikrokristalična celuloza, magnezijev stearat.
English: Somnolence Confusion Hallucinations1
Croatian: Manje često konfuzija Manje često halucinacije1
English: Sandoz d.d Representative office Teл.
Croatian: Sandoz d.d. representative office Latvia.
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje česte (mogu se javiti kod 1 na 100 osoba):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER
English: Memantine LEK belongs to a group of medicines called NMDA-receptor antagonists.
Croatian: Memantine LEK spada u skupinu lijekova poznatih kao antagonisti NMDA
English: Memantine LEK 20 mg film-coated tablets are presented as pale red, oval film-coated tablet scored in one side.
Croatian: Memantine LEK 20 mg filmom obložene tablete su blijedo crvene boje, ovalnog oblika, urezane na jednoj strani.
English: INFORMATION IN BRAILLE Memantine LEK 20 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Memantine LEK 20 mg
English: INFORMATION IN BRAILLE Memantine LEK 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Memantine LEK 10 mg
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: Nema podataka ili su podaci o primjeni memantina u trudnica ograničeni.Ispitivanja na životinjama upućuju na postojanje mogućnosti smanjenja intrauterinog rasta pri izloženosti dozama istim ili nešto višim nego što su kod ljudi (vidjeti dio 5.3).
English: In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Croatian: nekompenzirano kongestivno zatajenje srca (NYHA III-IV) ili nekontroliranu hipertenziju.
English: Memantine LEK contains the active substance memantine hydrochloride.
Croatian: Memantin LEK sadrži djelatnu tvar memantinklorid.
English: Memantine LEK is for oral use.
Croatian: Memantin LEK je za peroralnu primjenu.
English: Constipation Vomiting Pancreatitis2
Croatian: Nepoznato pankreatitis2
English: Marketing Authorisation Holder Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greece
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Grčka
English: From the fourth week on, the usual dose is 2 tablets once a day (1 x 20 mg).
Croatian: uobičajena doza je 2 tablete jedanput na dan (1 x 20 mg).
English: In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Croatian: U tom slučaju liječnik bi trebao u određenim razmacima nadzirati funkciju bubrega.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day as described above.
Croatian: Temeljem kliničkih ispitivanja, preporučena doza za bolesnike starije od 65 godina iznosi 20 mg dnevno
English: Women taking Memantine LEK should not breast-feed.
Croatian: Žene koje uzimaju Memantin LEK ne smiju dojiti.
English: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, iron oxide yellow (E172) and iron oxide red (E-172)
Croatian: Film ovojnica: poli(vinilni alkohol), titanijev dioksid (E171), talk, makrogol 3350, žuti željezov oksid (E172) i crveni željezov oksid (E172).
English: Very Rare (may affect up to 1 in 10,000 people): • Seizures
Croatian: Vrlo rijetke (mogu se javiti kod 1 na 10 000 osoba):
English: How to take Memantine LEK
Croatian: Kako uzimati Memantine LEK
English: Common Common Uncommon Very rare
Croatian: Manje često abnormalni hod Vrlo rijetko napadaji
English: 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
Croatian: amantadina, ketamina, dekstrometorfana dantrolena, baklofena cimetidina, ranitidina, prokainamida, kinidina, kinina, nikotina hidroklorotiazida (ili bilo koje kombinacije s hidroklorotiazidom)
English: Talk to your doctor or pharmacist before taking Memantine LEK
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Memantin LEK.
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: NMDA-receptorima, doprinosi izraženosti simptoma i progresiji bolesti kod neurodegenerativne demencije.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmathen S.A.
English: Administration of Memantine LEK is not recommended in patients with severe hepatic impairment.
Croatian: Ne preporučuje se primjena lijeka Memantine LEK kod bolesnika s teškim oštećenjem jetre.
English: Yellow, oval film-coated tablet scored in one side.
Croatian: Žuta filmom obložena tableta ovalnog oblika urezana na jednoj strani.
English: The patient should take one 20 mg film-coated tablet (20 mg) per day for 7 days.
Croatian: Bolesnik treba uzimati jednu filmom obloženu tabletu od 20 mg dnevno za 7 dana.
English: • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is coadministered with HCT or any combination with HCT.
Croatian: • Pri istodobnoj primjeni memantina i hidroklorotiazida (HCT-a), ili bilo koje od kombinacija s
English: Pale red, oval film-coated tablet scored in one side.
Croatian: Blijedo crvena filmom obložena tableta ovalnog oblika, urezana na jednoj strani.
English: What Memantine LEK is and what it is used for
Croatian: Što je Memantine LEK i za što se koristi Kako djeluje Memantine LEK
English: In patients with severe renal impairment (creatinine clearance 5 - 29 mL/min) daily dose should be 10 mg per day.
Croatian: Kod bolesnika s teškim oštećenjem bubrega (klirens kreatinina 5-29 mL/min) dnevna doza bi trebala biti
English: Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Croatian: Pharmathen S.A , 6, Dervenakion str., 15351 Pallini, Attiki, Grčka Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
English: How to store Memantine LEK
Croatian: Kako čuvati Memantine LEK
English: organizacna zlozka Tel: + 421-2/48 200 600
Croatian: Slovenská republika Sandoz d.d. organizacna zlozka Tel: + 421-2/48 200 600
English: 10 mg: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E
Croatian: Film ovojnica: poli(vinilni alkohol), titanijev dioksid (E171), talk, makrogol 3350 i žuti željezov oksid (E172).
English: Estonia Tel: + 372 6652405
Croatian: Sandoz d.d. Estonia Tel: + 372 6652405
English: Each 20 mg tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Croatian: Jedna 20 mg tableta sadrži 20 mg memantinklorida što odgovara 16,62 mg memantina.
English: Package leaflet: Information for the user Memantine LEK 10 mg film-coated tablets Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Croatian: Uputa o lijeku: Informacije za korisnika Memantin LEK 10 mg filmom obložene tablete Memantin LEK 20 mg filmom obložene tablete memantinklorid
English: Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Croatian: Jedna 10 mg tableta sadrži 10 mg memantinklorida što odgovara 8,31 mg memantina.
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Croatian: Alzheimerove bolesti (početne vrijednosti kratkog testa određivanja mentalnog statusa (MMSE) bile su 3-14) uključivalo je ukupno 252 ambulantna bolesnika.
English: PC:
Croatian: Tel.:
English: 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).
Croatian: Bolesnici liječeni memantinom pokazali su statistički značajno bolji učinak nego bolesnici koji su primali placebo u pogledu primarnih ishoda: skala procjene Alzheimerove bolesti (ADAS-cog) (p=0,003) i CIBIC-plus
English: Memantine LEK 20 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 56, 98 and 100 tablets.
Croatian: Memantine Lek 20 mg filmom obložene tablete su dostupne u PVC/PVDC-aluminij blister pakiranju sa 28, 30, 42, 56, 98 i 100 tableta.
English: EU/1/13/826 /007 28 film-coated tablets EU/1/13/826 /008 30 film-coated tablets EU/1/13/826 /009 42 film-coated tablets EU/1/13/826 /010 56 film-coated tablets EU/1/13/826 /011 98 film-coated tablets EU/1/13/826 /015 100 film-coated tablets
Croatian: EU/1/13/826 /007 28 filmom obloženih tableta EU/1/13/826 /008 30 filmom obloženih tableta EU/1/13/826 /009 42 filmom obloženih tableta EU/1/13/826 /010 56 filmom obloženih tableta EU/1/13/826 /011 98 filmom obloženih tableta EU/1/13/826 /015 100 filmom obloženih tableta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg memantinklorida, što odgovara 16,62 mg memantina.
English: 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.
Croatian: 1595 ih je dobivalo placebo, sveukupna stopa incidencije nuspojava u skupini liječenoj memantinom nije se razlikovala od stope incidencije nuspojava u skupini koja je primala placebo.
English: Memantine LEK 10 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 50, 56, 60, 98, 100 and 112 tablets.
Croatian: Memantine Lek 10 mg filmom obložene tablete su dostupne u PVC/PVDC-aluminij blister pakiranju sa 28, 30, 42, 50, 56, 60, 98, 100 i 112 tableta.
English: These factors include drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers.
Croatian: prelazak s mesne na vegetarijansku prehranu ili uzimanje izrazito velike količine alkalizirajućih želučanih pufera.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets
Croatian: NAZIV LIJEKA Memantin LEK 10 mg filmom obložene tablete
English: Tel: + 386 1 580 3327
Croatian: Lek Pharmaceuticals d.d. Tel: + 386 1 580 3327
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 50, 56, 60, 98, 100 and 112 film-coated tablets.
Croatian: Aluminij-PVC/PVDC blisteri, pakirani u kartonske kutije koje sadrže 28, 30, 42, 50, 56, 60, 98, 100 i 112 filmom obloženih tableta.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets
Croatian: NAZIV LIJEKA Memantin LEK 20 mg filmom obložene tablete
English: half 10 mg tablet week 2
Croatian: 1. tjedan pola tablete od 10 mg
English: België/Belgique/Belgien Sandoz n.v./s.a.
Croatian: België/Belgique/Belgien
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 56, 98 and 100 filmcoated tablets.
Croatian: Aluminij-PVC/PVDC blisteri, pakirani u kartonske kutije koje sadrže 28, 30, 42, 56, 98 i 100 filmom obloženih tableta.
English: Tel: + +420 225 775 111
Croatian: Sandoz s.r.o. Tel: + +420 225 775 111
English: P.T.Hadjigeorgiou Co Ltd Τηλ: + 357 - 25372425
Croatian: Τηλ: + 357 - 25372425
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Croatian: Memantine LEK 20 mg filmom obložene tablete memantinklorid
English: In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
Croatian: U drugom monoterapijskom ispitivanju blage do umjerene Alzheimerove bolesti randomizirano je ukupno 470
English: Do not take Memantine LEK
Croatian: Ako ste zaboravili uzeti Memantine LEK
English: 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 tablets once a day) as described above.
Croatian: Temeljem kliničkih ispitivanja, preporučena doza za bolesnike starije od 65 godina iznosi 20 mg na dan,
English: Slovenská republika Sandoz d.d.
Croatian: Sandoz d.d Representative office
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets memantine hydrochloride
Croatian: Memantin LEK 10 mg filmom obložene tablete memantinklorid
English: Iron oxide yellow (E 172) Iron oxide red (E 172)
Croatian: Ovojnica tablete poli(vinilni alkohol) makrogol 3350 titanijev dioksid (E 171) Talk željezov oksid, žuti (E 172) željezov oksid, crveni (E 172)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Croatian: Jedna filmom obložena tableta sadrži 20 mg memantinklorida, što odgovara 16,62 mg memantina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Croatian: Jedna filmom obložena tableta sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.
English: Dose
Croatian: Raspodjela
English: Dyspnoea
Croatian: Doziranje
English: Tablet coat
Croatian: IME NOSITELJA
English: Generally one kit is sufficient.
Croatian: Općenito dovoljan je jedan komplet.
English: It can be used in the following situations:
Croatian: Može se koristiti u sljedećim situacijama:
English: • patients who are still growing;
Croatian: • bolesnicima koji još uvijek rastu;
English: This summary was last updated in 02-2015.
Croatian: Sažetak je posljednji put obnovljen 02.2015.
English: The full EPAR for Inductos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • treating a fracture that is related to a disease such as Paget's disease or cancer.
Croatian: • liječenje frakture koje je povezano s bolešću, poput Pagetove bolesti ili raka.
English: Inductos must not be used in the following situations:
Croatian: Inductos se ne smije primjenjivati u sljedećim situacijama:
English: After two years, 57% of the patients treated with Inductos (69 out of 122) had responded to treatment, compared with 59% of the patients treated with a bone graft (78 out of 133).
Croatian: Nakon dvije godine, 57% bolesnika liječenih lijekom Inductos (69 od 122) odgovorilo je na terapiju, u usporedbi s 59% bolesnika liječenih koštanim presatkom (78 od 133).