FrancophonIA/ELRC3.0 huggingface dataset:
English: Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension) EMA/612121/2016 Rev.1
Croatian: Pitanja i odgovori o lijeku Clenil i povezanim nazivima (beklometazon dipropionat, suspenzija za atomizator od 400 i 800 mikrograma) EMA/612121/2016 Rev.1
English: In children with recurrent wheezing the response to treatment should be carefully monitored; if no benefit is observed within 2-3 months, Clenil should be discontinued.
Croatian: U djece s ponavljajućim piskanjem potrebno je pozorno pratiti odgovor na liječenje; ako se unutar 23 mjeseca ne uoče koristi, potrebno je obustaviti liječenje lijekom Clenil.
English: In children up to 5 years of age, the decision to start Clenil for the treatment of recurrent wheezing should be determined by the severity and frequency of the wheezing episodes.
Croatian: U djece u dobi do pet godina odluku za početak primjene lijeka Clenil za liječenje ponavljajućeg piskanja treba donijeti na temelju ozbiljnosti i učestalosti epizoda piskanja.
English: Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension)
Croatian: Pitanja i odgovori o lijeku Clenil i povezanim nazivima (beklometazon dipropionat, suspenzija za atomizator od 400 i 800 mikrograma)
English: The Committee agreed that Clenil should no longer be used to treat common bronchostenotic conditions (narrowing of the airways in the lungs) because of the lack of rigorous evidence from adequately designed clinical studies.
Croatian: Odbor se složio da se lijek Clenil više ne bi smio primjenjivati za liječenje uobičajenih bronhostenotičkih stanja (sužavanja dišnih putova u plućima) zbog nedostatka čvrstih dokaza iz odgovarajuće izrađenih kliničkih ispitivanja.
English: The CHMP agreed that Clenil can be used for the maintenance treatment of asthma in adults and children when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate.
Croatian: CHMP se složio da se lijek Clenil može primjenjivati u odraslih osoba i djece u terapiji održavanja za liječenje astme ako je primjena inhalatora s tlačenim inhalatom ili suhim praškom nezadovoljavajuća ili neodgovarajuća.
English: The CHMP also agreed that Clenil should no longer be used to treat allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites) because the available data do not support this use and other medicines available as nasal sprays may be better tolerated.
Croatian: CHMP se također složio da se lijek Clenil više ne bi smio primjenjivati za liječenje alergijskog rinitisa (upale nosne šupljine prouzročene alergijom, primjerice peludnom groznicom ili alergijom na grinje) jer ta primjena nije poduprta dostupnim podacima te bi se bolje mogli podnositi drugi dostupni lijekovi u obliku sprejeva za nos.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave u okviru Odbora, mišljenje je CHMP-a da se sažeci opisa svojstava lijeka, označivanje i upute o lijeku moraju uskladiti na razini EU-a.
English: On 15 September 2016, the European Medicines Agency completed a review of Clenil.
Croatian: Europska agencija za lijekove dovršila je ocjenjivanje lijeka Clenil 15. rujna 2016.
English: Clenil was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska skupina za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) utvrdila je da je u pogledu lijeka Clenil potrebno provesti usklađivanje.
English: Tmax is between 3 and 8 hours.
Croatian: Vrijednost Tmax je između 3 i 8 sati.
English: 8501 Novo mesto SLOVENIA
Croatian: 8501 Novo mesto SLOVENIJA
English: BLISTER (PVC/PVDC-Alu FOIL)
Croatian: BLISTER (PVC/PVDC-Alu FOLIJA)
English: - Do not take a double dose to make up for a forgotten dose.
Croatian: - Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
English: - The other ingredients (excipients) are:
Croatian: - Ostali sastojci (pomoćne tvari) su:
English: Continue to take Marixino as long as it is of benefit to you.
Croatian: Nastavite uzimati Marixino onoliko dugo koliko od nje imate koristi.
English: Marixino with food and drink
Croatian: Marixino s hranom i pićem
English: Memantine should not be used during pregnancy unless clearly necessary.
Croatian: Memantin se ne smije upotrebljavati tijekom trudnoće, osim ako to nije izričito potrebno.
English: Paediatric population No data available.
Croatian: Pedijatrijska populacija Nema dostupnih podataka.
English: Other medicines and Marixino
Croatian: Drugi lijekovi i Marixino
English: Children and adolescents Marixino is not recommended for children and adolescents under the age of 18 years.
Croatian: Djeca i adolescenti Marixino se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: Some factors that may raise urine pH (see section 5.2 'Elimination') may necessitate careful monitoring of the patient.
Croatian: Neki čimbenici koji mogu povisiti pH mokraće (vidjeti dio 5.2 “Eliminacija”) mogu zahtijevati pažljivo nadziranje bolesnika.
English: It belongs to a group of medicines known as anti-dementia medicines.
Croatian: On pripada skupini lijekova poznatih kao lijekovi protiv demencije.
English: Your doctor should assess your treatment on a regular basis.
Croatian: Liječnik treba redovito procjenjivati Vaše liječenje.
English: If you forget to take Marixino - If you find you have forgotten to take your dose of Marixino, wait and take your next dose at the usual time.
Croatian: Ako ste zaboravili uzeti Marixino - Ako ustanovite da ste zaboravili uzeti dozu lijeka Marixino, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: The volume of distribution is around 10 l/kg.
Croatian: Volumen raspodjele je oko 10 l/kg.
English: About 45 % of memantine is bound to plasma-proteins.
Croatian: Oko 45% memantina veže se na proteine plazme.
English: Date of first authorisation: 29 April 2013 Date of latest renewal: 18 January 2018
Croatian: Datum posljednje obnove odobrenja: 18. siječnja 2018.
English: What Marixino is and what it is used for
Croatian: Što je Marixino i za što se koristi
English: There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Croatian: Objavljen je jedan slučaj o mogućem riziku također za kombinaciju memantina i fenitoina.
English: If you go into hospital, let your doctor know that you are taking Marixino.
Croatian: Ako dođete u bolnicu, obavijestite svog liječnika da uzimate Marixino.
English: Very Rare (may affect up to 1 in 10,000 people): - Seizures.
Croatian: Vrlo rijetke (mogu se javiti u manje od 1 na 10 000 osoba): - Napadaji.
English: Do not take Marixino: - if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Marixino: - ako ste alergični (preosjetljivi) na memantin ili bilo koji drugi sastojak ovog lijeka (navedenih u dijelu 6).
English: Memantine has an absolute bioavailability of approximately 100 %.
Croatian: Memantin ima apsolutnu bioraspoloživost od približno 100%.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
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 Alzheimerove demencije.
English: This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.
Croatian: Ova će se doza povećavati za 5 mg tjedno dok se ne postigne preporučena doza (doza održavanja).
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: As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Croatian: Posljedično, dostupni su samo ograničeni podaci te je potrebno pažljivo nadzirati bolesnike s navedenim stanjima.
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Croatian: Ispitivanja na dobrovoljcima pokazala su linearnu farmakokinetiku u rasponu doza od 10 do 40 mg.
English: It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
Croatian: On modulira učinke patološki povišenih toničnih razina glutamata koje mogu dovesti do disfunkcije neurona.
English: The tablets can be taken with or without food.
Croatian: Tablete se mogu uzimati s hranom ili bez nje.
English: Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Croatian: Alzheimerova bolest povezuje se s depresijom, suicidalnim idejama i suicidom.
English: Adverse reactions are ranked according to system organ class, using the following convention:very common ( 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: Nuspojave su razvrstane prema klasifikaciji organskih sustava, koristeći iduću konvenciju: vrlo često (≥1/10), često (≥1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: None of these metabolites exhibit NMDAantagonistic activity.
Croatian: Nijedan od navedenih metabolita ne pokazuje NMDA-antagonističku aktivnost.
English: Marixino should be administered orally once a day and should be taken at the same time every day.
Croatian: Marixino treba primjenjivati peroralno jednom dnevno i potrebno ga je uzimati svaki dan u isto vrijeme.
English: - If you take a large overdose of Marixino, contact your doctor or get medical advice, as you may need medical attention.
Croatian: - Ako ste uzeli preveliku dozu lijeka Marixino, javite se Vašem liječniku za savjet, jer bi Vam mogla zatrebati medicinska pomoć.
English: From Week 4 on:
Croatian: Od 4. tjedna nadalje:
English: What you need to know before you take Marixino
Croatian: Što morate znati prije nego počnete uzimati Marixino
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 u ljudi, no, uzimajući u obzir lipofilnost tvari, do toga vjerojatno dolazi.
English: - Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Croatian: - Potrebno je izbjegavati istodobnu primjenu memantina i amantadina zbog rizika od farmakotoksične psihoze.
English: See section 2 "Marixino contains lactose".
Croatian: Vidjeti dio 2 „Marixino sadrži laktozu“.
English: Elevated liver function test
Croatian: Često povišeni rezultati testa jetrene funkcije
English: Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Croatian: Halucinacije su opažene uglavnom kod bolesnika s teškom Alzheimerovom bolešću.
English: C-memantine, a mean of 84 % of the dose was recovered within 20 days, more than 99 % being excreted renally.
Croatian: C-memantin, uklonjeno je prosječno 84% doze unutar 20 dana, više od 99% izlučeno je putem bubrega.
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: In a study using orally administered
Croatian: U ispitivanju u kojem je korišten peroralno primijenjen
English: These compounds 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: The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3 % vs 5.6 %, respectively), headache (5.2 % vs 3.9 %), constipation (4.6 % vs 2.6 %), somnolence (3.4 % vs 2.2 %) and hypertension (4.1 % vs 2.8 %).
Croatian: Nuspojave koje su se najčešće pojavljivale s većom učestalošću u skupini bolesnika liječenih memantinom nego u skupini koja je uzimala placebo bile su omaglica (6,3% naspram 5,6%), glavobolja (5,2% naspram 3,9%), konstipacija (4,6% naspram 2,6%), somnolencija (3,4% naspram 2,2%) i hipertenzija (4,1% naspram 2,8%).
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven GERMANY
Croatian: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven NJEMAČKA
English: Pharmacotherapeutic group: Psychoanaleptics, other anti-dementia drugs, ATC code: N06DX01.
Croatian: Farmakoterapijska skupina: psihoanaleptici, ostali lijekovi protiv demencije, ATK oznaka: N06DX01.
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: 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 primjenom ponovljenih doza kod glodavaca i pasa, ali ne i kod majmuna.
English: The maximum daily dose is 20 mg per day.
Croatian: Maksimalna dnevna doza je 20 mg na dan.
English: Also, Marixino may change your reactivity, making driving or operating machinery inappropriate.
Croatian: Marixino također može promijeniti Vašu sposobnost reagiranja, što čini upravljanje vozilima i rad sa strojevima neprikladnima.
English: How to take Marixino
Croatian: Kako uzimati Marixino
English: The 10 mg film-coated tablet can be divided into equal doses.
Croatian: Filmom obložena tableta od 10 mg se može podijeliti na jednake doze.
English: Once daily
Croatian: Jednom dnevno.
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 toliko dugo dok je terapijska korist povoljna i dok bolesnik dobro podnosi liječenje memantinom.
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: 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, nekompenzirano kongestivno zatajenje srca (NYHA III-IV) ili nekontroliranu hipertenziju.
English: The patient recovered without permanent sequelae.
Croatian: Bolesnik se oporavio bez trajnih posljedica.
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 ukazuju na postojanje mogućnosti smanjenja intrauterinog rasta pri izloženosti dozama istim ili nešto višim nego što su kod ljudi (vidjeti dio 5.3).
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 važećim kliničkim smjernicama.
English: The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4
Croatian: Preporučena doza održavanja je 20 mg jednom dnevno koja se postiže na početku 4. tjedna.
English: In particular, Marixino may change the effects of the following medicines and their dose may need to be adjusted by your doctor: - 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: Posebice, Marixino može promijeniti učinak sljedećih lijekova, te će liječnik možda morati prilagoditi njihovu dozu: - amantadina, ketamina, dekstrometorfana - dantrolena, baklofena - cimetidina, ranitidina, prokainamida, kinidina, kinina, nikotina - hidroklorotiazida (ili bilo koja kombinacija s hidroklorotiazidom) - antikolinergika (lijekovi koje se uglavnom koriste za liječenje poremećaja kretanja ili crijevnih grčeva) - antikonvulziva (lijekovi koji se koriste za sprječavanje i ublažavanje napadaja) - barbiturata (lijekovi koji se uglavnom koriste za uspavljivanje) - dopaminergičkih agonista (lijekovi kao što su L-dopa, bromokriptin), - neuroleptika (lijekovi koji se koriste za liječenje mentalnih poremećaja), - oralnih antikoagulansa.
English: Marixino belongs to a group of medicines called NMDA-receptor antagonists.
Croatian: Marixino spada u skupinu lijekova poznatih kao antagonisti NMDA receptora.
English: Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur: - 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: Zbog farmakoloških učinaka i mehanizma djelovanja memantina moguće su sljedeće interakcije: - Način djelovanja sugerira da bi učinci L-dope, dopaminergičkih agonista i antikolinergika mogli biti pojačani pri istodobnom liječenju NMDA-antagonistima poput memantina.
English: Furthermore, Marixino has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Croatian: Nadalje, Marixino ima blagi ili umjereni utjecaj na sposobnost upravljanja vozilima i rada sa strojevima, pa ambulantne bolesnike treba upozoriti da na to obrate posebnu pozornost.
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: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
Croatian: Kod bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije (Child-Pugh A i Child-Pugh B) nije potrebna prilagodba doze.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske Agencije za lijekove: http://www.ema.europa.eu.
English: If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Croatian: Ako imate oštećenje bubrega (problemi s bubrezima), liječnik treba pažljivo pratiti funkciju Vaših bubrega i ovisno o njoj, prilagoditi dozu memantina, ako je to potrebno.
English: Blister (PVC/PVDC-Alu foil): 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets, in a carton box.
Croatian: Blister (PVC/PVDC-Alu folija): 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 i 112 filmom obloženih tableta, u kutiji.
English: Marixino contains lactose
Croatian: Marixino sadrži laktozu
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske Agencije za lijekove http://www.ema.europa.eu.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake EXP.
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 mogli bi također stupiti u interakciju s memantinom i dovesti do potencijalnog rizika povišenja njegove koncentracije u plazmi.
English: These events have been reported in patients treated with memantine.
Croatian: Ovi su događaji prijavljivani kod bolesnika liječenih memantinom.
English: Talk to your doctor or pharmacist before taking Marixino: - 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 Marixino: - ako u povijesti bolesti 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: Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.
Croatian: Iako uzročna povezanost nije utvrđena, preporučljivo je pažljivo praćenje protrombinskog vremena, odnosno INR-a kod bolesnika koji se istodobno liječe oralnim antikoagulansima.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before talking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego što uzmete ovaj lijek.