FrancophonIA/ELRC3.0 huggingface dataset:
English: Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.
Slovenian: 4.1 Terapevtske indikacije Zdravilo Doptelet je indicirano za zdravljenje hude trombocitopenije pri odraslih bolnikih s kronično boleznijo jeter, pri katerih je načrtovan invazivni poseg.
English: Tablet core: lactose monohydrate (see section 2 “Doptelet contains lactose”); microcrystalline cellulose [E460(i)]; crospovidone type B [E1202]; silica, colloidal anhydrous [E551]; magnesium stearate [E470b].
Slovenian: Jedro tablete: laktoza monohidrat (glejte poglavje 2 »Zdravilo Doptelet vsebuje laktozo«); mikrokristalna celuloza [E460(i)]; krospovidon tipa B [E1202]; brezvoden koloidni silicijev dioksid [E551]; magnezijev stearat [E470b].
English: Avatrombopag did not affect fertility or early embryonic development in male rats at exposures 22-times, or in female rats at exposures 114-times, the AUC observed in patients at the recommended dose of 60 mg once daily.
Slovenian: Avatrombopag ni vplival na plodnost ali zgodnji embrionalni razvoj pri samcih podgan ob izpostavljenosti 22-kratnika oz. pri samicah podgan ob izpostavljenosti 114-kratnika vrednosti AUC
English: 10 film-coated tablets 15 film-coated tablets
Slovenian: 15 filmsko obloženih tablet
English: Co-administration of avatrombopag with either a high-fat or low-fat meal did not result in clinically important changes in rate or extent of absorption of avatrombopag.
Slovenian: Sočasno dajanje avatrombopaga z obrokom z veliko vsebnostjo maščob oz. obrokom z majhno vsebnostjo maščob ni pokazalo klinično pomembnih sprememb hitrosti ali obsega absorpcije avatrombopaga.
English: Based on the known metabolic profile of avatrombopag and the fact that only 6% of the dose is excreted in urine, the likelihood of effects of renal impairment on pharmacokinetics of avatrombopag is considered to be very low (see sections 4.2 and 4.8).
Slovenian: odmerka izloča v urin, se šteje, da je verjetnost učinkov okvare ledvic na farmakokinetiko avatrombopaga zelo majhna (glejte poglavji 4.2 in 4.8).
English: The population pharmacokinetic analysis of avatrombopag in healthy subjects and subjects with thrombocytopenia due to chronic liver disease indicated similar exposures between healthy subjects and subjects with mild and moderate renal impairment (CrCL ≥ 30 mL/min, Cockcroft-Gault).
Slovenian: Populacijska farmakokinetična analiza avatrombopaga pri zdravih preiskovancih in preiskovancih s trombocitopenijo zaradi kronične bolezni jeter je pokazala podobno izpostavljenost pri zdravih preiskovancih in preiskovancih z blago do zmerno okvaro ledvic (CrCL ≥ 30 ml/min, Cockcroft-Gault).
English: Doptelet was not studied in patients with prior thromboembolic events.
Slovenian: Zdravila Doptelet pri bolnikih s tromboemboličnimi dogodki v anamnezi niso proučevali.
English: While the benefit-risk profile for procedures that were not specifically included in the clinical studies is likely to be comparable, the efficacy and safety of avatrombopag have not been established in major surgeries like laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.
Slovenian: Sicer je pri posegih, ki niso bili posebej vključeni v klinične študije, razmerje med tveganji in koristmi najverjetneje podobno, vendar pa učinkovitost in varnost avatrombopaga pri večjih kirurških posegih, npr. laparotomiji, torakotomiji,
English: Table 2: Efficacy results by baseline platelet count cohort and treatment group - Study 1 and Study 2
Slovenian: Preglednica 2: Rezultati o učinkovitosti glede na kohorto bolnikov z majhnim/velikim številom trombocitov ob izhodišču in skupino zdravljenja - Študija 1 in Študija 2
English: In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n = 1/430) with chronic liver disease and thrombocytopenia which was reported 14 days after treatment with Doptelet ended.
Slovenian: V okviru kliničnih preskušanj ADAPT-1 in ADAPT-2 so 14 dni po končanem zdravljenju z zdravilom Doptelet poročali o enem dogodku tromboze portalne vene, nastalem zaradi zdravljenja, in sicer pri bolniku (n = 1/430) s kronično boleznijo jeter in trombocitopenijo.
English: Doptelet is not recommended in pregnancy and in women who are able to have children and are not using contraception.
Slovenian: Zdravila Doptelet ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Avatrombopag is a substrate for p-glycoprotein (P-gp) mediated transport, although no clinically important differences in platelet count elevations are expected when avatrombopag is co-administered with a strong P-gp inhibitor.
Slovenian: Avatrombopag je substrat za prenos s p-glikoproteinom (P-gp), čeprav pri sočasnem dajanju avatrombopaga in močnega zaviralca P-gp ni pričakovati klinično pomembnih razlik v povečanju števila trombocitov.
English: If you have any questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna kakršna koli vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: High baseline platelet count (≥ 40 to < 50 x 109/L)
Slovenian: Veliko število trombocitov ob izhodišču (≥ 40 do < 50 x 109/l)
English: Film coating: poly(vinyl alcohol) [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; iron oxide yellow [E172].
Slovenian: Filmska obloga: polivinilalkohol [E1203]; smukec [E553b]; makrogol 3350 [E1521]; titanijev dioksid [E171]; železov oksid [E172].
English: Avatrombopag does not stimulate platelet production in mice, rats, monkeys, or dogs because of the unique TPO receptor specificity.
Slovenian: Avatrombopag zaradi edinstvene specifičnosti za receptorje TPO ne spodbuja tvorbe trombocitov pri miših, podganah, opicah ali psih.
English: The apparent volume of distribution of avatrombopag in patients with thrombocytopenia and chronic liver disease based on population pharmacokinetic analysis is approximately 180 L, suggesting that avatrombopag is extensively distributed.
Slovenian: Glede na populacijsko farmakokinetično analizo pri bolnikih s trombocitopenijo in kronično boleznijo jeter znaša navidezni volumen porazdelitve avatrombopaga približno 180 l, kar kaže na obsežno porazdelitev avatrombopaga.
English: The usual recommended dose is either 40 mg (2 tablets) or
Slovenian: Običajen priporočeni odmerek je bodisi 40 mg (2 tableti) ali 60 mg (3 tablete) na dan 5 dni zapored.
English: Mean platelet count (+/- standard error) by days from start of dosing by baseline platelet count cohort and treatment group - pooled Study 1 and Study 2
Slovenian: Slika 1:Povprečno število trombocitov (+/- standardna napaka) po dnevih od začetka odmerjanja glede na kohorto bolnikov z majhnim/velikim številom trombocitov ob izhodišču in skupino zdravljenja - zbrani podatki iz Študije 1 in Študije 2
English: Portal vein thrombosis
Slovenian: Tromboza portalne vene
English: There is limited information on the use of avatrombopag in patients previously exposed to avatrombopag.
Slovenian: O uporabi avatrombopaga pri bolnikih, ki so se predhodno zdravili z avatrombopagom, je malo podatkov.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Doptelet in all subsets of the paediatric population in thrombocytopenia secondary to liver disease (see section 4.2 for information on paediatric use).
Slovenian: Doptelet za vse podskupine pediatrične populacije pri zdravljenju trombocitopenije, ki je posledica bolezni jeter (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Population pharmacokinetic analysis of avatrombopag plasma concentrations from the clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease indicated that avatrombopag exposures were similar across the different races studied.
Slovenian: Populacijska farmakokinetična analiza plazemskih koncentracij avatrombopaga iz kliničnih študij pri zdravih preiskovancih in bolnikih s trombocitopenijo zaradi kronične bolezni jeter je pokazala podobno izpostavljenost avatrombopagu v vseh proučevanih rasnih skupinah.
English: A population pharmacokinetic analysis evaluated avatrombopag plasma exposures in patients with mild to moderate hepatic impairment based on Model for End-Stage Liver Disease (MELD) scores and Child-Turcotte-Pugh scores.
Slovenian: S populacijsko farmakokinetično analizo so ocenili plazemsko izpostavljenost avatrombopagu pri bolnikih z blago do zmerno okvaro jeter na podlagi točk po prognostičnem modelu napredovale jetrne bolezni (MELD - Model for End-Stage Liver Disease) in točk po Child-Turcotte-Pughovi lestvici.
English: - you are allergic to avatrombopag or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Doptelet Ne jemljite zdravila Doptelet: če ste alergični na avatrombopag ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Hypersensitivity to avatrombopag or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na avatrombopag ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: Moderate CYP2C9 and strong CYP3A inducer
Slovenian: Zmerni zaviralec CYP2C9 in močan zaviralec CYP3A
English: Pharmacokinetics and pharmacodynamics of avatrombopag have not been investigated in patients with severe renal impairment (CrCL < 30 mL/min, Cockcroft-Gault) including patients requiring haemodialysis.
Slovenian: (CrCL < 30 ml/min, Cockcroft-Gault), vključno z bolniki, ki potrebujejo hemodializo, niso preučevali.
English: Due to limited information available, the safety and efficacy of avatrombopag in patients with severe hepatic impairment (Child-Pugh class C, MELD score > 24) have not been established (see section 4.4).
Slovenian: Varnost in učinkovitost avatrombopaga pri bolnikih s hudo okvaro jeter (razred C po Child-Pughovi lestvici, > 24 točk po lestvici MELD) zaradi pomanjkanja podatkov še nista bili dokazani (glejte poglavje 4.4).
English: Lactose monohydrate Microcrystalline cellulose (E460(i)) Crospovidone type B (E1202) Silica, colloidal anhydrous (E551) Magnesium stearate (E470b)
Slovenian: Mikrokristalna celuloza (E460(i)) Krospovidon tipa B (E1202) Brezvoden koloidni silicijev dioksid (E551) Magnezijev stearat (E470b)
English: Two doses should not be taken at one time to make up for a missed dose.
Slovenian: Bolnik ne sme vzeti dvojnega odmerka, da bi nadomestil izpuščenega.
English: Co-administered drug*
Slovenian: Sočasno uporabljeno zdravilo*
English: - The active substance is avatrombopag.
Slovenian: Učinkovina je avatrombopag.
English: Strong CYP3A inhibitor
Slovenian: Močan zaviralec CYP3A
English: Doptelet 20 mg film-coated tablets avatrombopag
Slovenian: Doptelet 20 mg filmsko obložene tablete avatrombopag
English: Doptelet 20 mg tablets avatrombopag
Slovenian: IME ZDRAVILA Doptelet 20 mg tablete avatrombopag
English: No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
Slovenian: Pri bolnikih z blago (razred A po Child-Pughovi lestvici) ali zmerno (razred B po Child-Pughovi lestvici) okvaro jeter prilagoditev odmerka ni potrebna.
English: In each study, patients were assigned to the low baseline platelet count cohort (˂ 40 x 109/L) or the high baseline platelet count cohort (≥ 40 to ˂ 50 x 109/L) based on their platelet count at baseline.
Slovenian: V posamezni študiji so bili bolniki na podlagi njihovega števila trombocitov ob izhodišču razvrščeni bodisi v kohorto bolnikov z majhnim številom trombocitov ob izhodišču (˂ 40 x 109/l) ali pa v kohorto bolnikov z velikim številom trombocitov ob izhodišču (≥ 40 do ˂ 50 x 109/l).
English: There is limited information on the use of avatrombopag in patients with severe (Child-Pugh class C, MELD score > 24) hepatic impairment.
Slovenian: Huda okvara jeter O uporabi avatrombopaga pri bolnikih s hudo okvaro jeter (razred C po Child-Pughovi lestvici,
English: Strong CYP3A4/5 or CYP2C9 inducers
Slovenian: Močni induktorji CYP3A4/5 ali CYP2C9
English: If you are not sure, talk to your doctor or pharmacist before taking Doptelet.
Slovenian: Če dojite, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Doptelet.
English: Low baseline platelet count cohort (< 40 x 109/L)
Slovenian: Kohorta bolnikov z majhnim številom trombocitov ob izhodišču (< 40 x 109/l)
English: P-gp and moderate CYP3A inhibitor
Slovenian: Zaviralec P-gp in zmerni zaviralec CYP3A Verapamil
English: CYP3A4/5 and CYP2C9 inhibitors
Slovenian: Zaviralci CYP3A4/5 in CYP2C9
English: Moderate CYP3A and CYP2C9 inhibitor
Slovenian: Zmerni zaviralec CYP3A in CYP2C9 Flukonazol
English: Contains lactose, see leaflet for further information.
Slovenian: Za več informacij glejte navodilo za uporabo.
English: Macrogol 3350 (E1521) Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: Filmska obloga Polivinilalkohol (E1203) Smukec (E553b) Makrogol 3350 (E1521) Titanijev dioksid (E171) Rumeni železov oksid (E172)
English: However, there was a significant reduction (by approximately 50%) in the between- and within-subject variability of avatrombopag AUC and Cmax when administered with food (see sections 4.2 and 4.5).
Slovenian: Vendar pa so pri dajanju skupaj s hrano (glejte poglavji 4.2 in 4.5) ugotovili pomembno zmanjšanje (za približno 50%) interindividualne in intraindividualne variabilnosti za AUC in Cmax avatrombopaga.
English: Avatrombopag was present in milk of lactating rats after oral administration of radioactive labeled avatrombopag.
Slovenian: Po peroralnem dajanju radioaktivno označenega avatrombopaga so v mleku doječih podgan ugotovili prisotnost avatrombopaga.
English: Doptelet 20 mg film-coated tablets
Slovenian: IME ZDRAVILA Doptelet 20 mg filmsko obložene tablete
English: Hepatic impairment
Slovenian: Žilne bolezni
English: Retreatment
Slovenian: ZDRAVILA
English: In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.9 x 109/L.
Slovenian: V kohorti bolnikov z velikim številom trombocitov ob izhodišču je povprečno število trombocitov ob izhodišču pri bolnikih, zdravljenih z avatrombopagom, znašalo 44,3 x 109/l, pri bolnikih, zdravljenih s placebom, pa 44,9 x 109/l.
English: Avatrombopag has not been studied in patients with severe renal impairment (see section 5.2); however, given the short duration of treatment, no dose adjustment is recommended.
Slovenian: Pri bolnikih s hudo okvaro ledvic avatrombopaga niso proučevali (glejte poglavje 5.2.
English: How to store Doptelet
Slovenian: Shranjevanje zdravila Doptelet
English: Based on in vitro studies, no other transporting proteins (OATP1B1, OATP1B3, OCT2, OAT1, and OAT3) are expected to play a significant role in the disposition of avatrombopag.
Slovenian: OATP1B3, OCT2, OAT1 oz. OAT3) imela pomembno vlogo pri porazdelitvi avatrombopaga.
English: In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.5 x 109/L.
Slovenian: V kohorti bolnikov z velikim številom trombocitov ob izhodišču je povprečno število trombocitov ob izhodišču pri bolnikih, zdravljenih z avatrombopagom, znašalo 44,3 x 109/l, pri bolnikih, zdravljenih s placebom, pa 44,5 x 109/l.
English: Bone pain Myalgia
Slovenian: Ok vara jeter
English: Population pharmacokinetic analysis of avatrombopag plasma concentrations from clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease, that included 11% (84/787) of the study population ≥ 65 years of age, suggested that avatrombopag exposures are not affected by age (see section 4.2).
Slovenian: 11% (84/787) študijske populacije preiskovancev, starih ≥ 65 let, je pokazala, da starost ne vpliva na izpostavljenost avatrombopagu (glejte poglavje 4.2).
English: Driving and using machines
Slovenian: OZNAČEVANJE IN NAVODILA ZA UPORABO
English: Package leaflet: Information for the patient Doptelet 20 mg film-coated tablets avatrombopag This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo: Informacije za bolnika Doptelet 20 mg filmsko obložene tablete avatrombopag
English: Doptelet 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Doptelet 20 mg
English: Avatrombopag 40 mg (n = 58) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec a Two-sided 95% confidence interval based on normal approximation.
Slovenian: Povprečna vrednost x 109/l P-vrednostc a Dvostranski 95-odstotni interval zaupanja na osnovi normalne aproksimacije.
English: Obtain a platelet count prior to the administration of Doptelet therapy and on the day of a procedure to ensure an adequate increase in platelet count, and no unexpectedly high increase in platelet count in the patient populations specified in sections 4.4 and 4.5.
Slovenian: Doptelet in na dan posega, določite število trombocitov, da zagotovite zadostno povečanje števila trombocitov in odsotnost nepričakovano velikega povečanja števila trombocitov.
English: No clinically important difference in avatrombopag exposures were observed between patients with Child-Turcotte-Pugh Scores (Range = 5 to 12) or MELD scores (Range = 4 to 23) and healthy subjects.
Slovenian: Med bolniki, ocenjenimi s točkami (razpon = 5 do 12) po Child-Turcotte-Pughovi lestvici, oz. bolniki,
English: In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 32.7 x 109/L and for placebo-treated patients was 32.5 x 109/L.
Slovenian: zdravljenih z avatrombopagom, znašalo 32,7 x 109/l, pri bolnikih, zdravljenih s placebom, pa
English: Verapamil
Slovenian: Mialgija
English: Avatrombopag 60 mg (n = 70) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec
Slovenian: Sprememba števila trombocitov od izhodišča do dneva posega Povprečna vrednost (SD) x 109/l Povprečna vrednost x 109/l
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Dova Pharmaceuticals Ireland Limited
English: In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 31.1 x 109/L and for placebo-treated patients was 30.7 x 109/L.
Slovenian: zdravljenih z avatrombopagom, znašalo 31,1 x 109/l, pri bolnikih, zdravljenih s placebom, pa
English: Memantine Accord should be given once a day at the same time every day.
Slovenian: Zdravilo Memantine Accord se daje enkrat dnevno, vsak dan ob istem času.
English: It is used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Slovenian: Uporablja se za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo, ki je vrsta demence (možganske bolezni), ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
English: To prevent side effects, the dose of Memantine Accord is gradually increased over the first three weeks of treatment: during the first week, the daily dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Slovenian: Da se preprečijo neželeni učinki, se odmerek zdravila Memantine Accord v prvih treh tednih zdravljenja postopoma povečuje: prvi teden je odmerek 5 mg; drugi teden 10 mg, tretji teden pa 15 mg. Od četrtega tedna naprej je priporočeni vzdrževalni odmerek 20 mg enkrat na dan.
English: Memantine Accord is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Memantine Accord je na voljo v obliki tablet (5 mg, 10 mg, 15 mg in 20 mg) in se izdaja le na recept.
English: The full EPAR for Memantine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Memantine Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Memantine Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Axura.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Axura.
English: Memantine works by blocking types of receptors called N-methyl-D-aspartate (NMDA) receptors, to which the neurotransmitter glutamate normally attaches.
Slovenian: Memantin deluje tako, da zavira vrsto receptorjev, imenovanih receptorji za N-metil-D-aspartat (NMDA), na katere se navadno veže živčni prenašalec glutamat.
English: This is a summary of the European public assessment report (EPAR) for Memantine Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Memantine Accord.
English: The company provided data on the medicine's solubility, composition and absorption in the body.
Slovenian: Družba je predložila podatke o topnosti in sestavi zdravila ter o njegovi absorpciji v telesu.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine Accord by the patient.
Slovenian: Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo uporabo zdravila Memantine Accord.
English: The Committee recommended that Memantine Accord be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Memantine Accord odobri za uporabo v EU.
English: Because Memantine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Memantine Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Slovenian: Memantin z zaviranjem receptorjev NMDA izboljša prenos signalov v možganih in zmanjša simptome Alzheimerjeve bolezni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Accord on 04 December 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Memantine Accord, veljavno po vsej Evropski uniji, izdala 04. decembra 2013.
English: What measures are being taken to ensure the safe and effective use of Memantine Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Memantine Accord?
English: A risk management plan has been developed to ensure that Memantine Accord is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Memantine Accord je bil pripravljen načrt obvladovanja tveganj.
English: What are the benefits and risks of Memantine Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Memantine Accord?
English: Memantine Accord memantine
Slovenian: Memantine Accord memantin