FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, the Committee recommends that the concerned marketing authorisations should be suspended unless the medicinal product is considered critical by the relevant national competent authorities.
Croatian: Nadalje, Odbor preporučuje da se dotična odobrenja za stavljanje lijeka u promet obustave ako relevantna nacionalna nadležna tijela taj lijek ne smatraju izrazito važnim.
English: For all other marketing authorisation applications subject to this referral the CHMP considers that the applicants did not submit information which allows establishing bioequivalence to the EU reference medicinal product, and therefore the marketing authorisation applications do not currently fulfil the criteria for authorisation.
Croatian: U pogledu svih ostalih zahtjeva za odobrenje za stavljanje lijeka u promet koji su podložni ovom upućivanju, CHMP smatra da podnositelji zahtjeva nisu dostavili informacije koje bi omogućile utvrđivanje bioekvivalencije u odnosu na referentni lijek odobren u EU-u i stoga zahtjevi za odobrenje za stavljanje lijeka u promet trenutačno ne ispunjavaju kriterije za izdavanje odobrenja.
English: Bioequivalence (BE) is required for the conclusion that efficacy and safety are similar to those of the reference medicinal product for a medicinal product with a marketing authorisation or marketing authorisation application under Article 10(1) of Directive 2001/83/EC.
Croatian: Bioekvivalencija (BE) je potrebna kako bi se utvrdilo da su djelotvornost i sigurnost lijeka koji je odobren za stavljanje u promet ili za koji je podnesen zahtjev za odobrenje za stavljanje lijeka u promet slični onima referentnog lijeka u skladu s člankom 10. stavka 1. Direktive 2001/83/EZ.
English: The CHMP therefore recommended the suspension of the marketing authorisations for all remaining medicinal products concerned by this referral procedure, as bioequivalence vis-à-vis the EU reference medicinal products has not been demonstrated.
Croatian: CHMP je stoga preporučio obustavu odobrenja za stavljanje lijeka u promet za sve preostale lijekove koji su obuhvaćeni ovim postupkom upućivanja s obzirom na to da nije utvrđena bioekvivalencija u odnosu na referentne lijekove odobrene u EU-u.
English: For these medicinal products considered critical by EU Member State(s), the marketing authorisations holders shall submit a bioequivalence study conducted vis-à-vis the EU Reference Medicinal Product within 12 months from the Commission Decision.
Croatian: Za lijekove koje država članica EU-a (ili više njih) smatra izrazito važnima, nositelji odobrenja za stavljanje lijeka u promet dostavit će ispitivanje bioekvivalencije provedeno u odnosu na referentni lijek odobren u EU-u unutar 12 mjeseci od donošenja odluke Komisije.
English: An authorised medicinal product may be considered critical by the EU Member States based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member States and, as appropriate, the nature of the disease to be treated.
Croatian: Države članice EU-a mogu zaključiti da je lijek izrazito važan na temelju ocjene potencijalno neudovoljene medicinske potrebe, uzimajući u obzir dostupnost odgovarajućih alternativnih lijekova u dotičnim državama članicama EU-a i, ako je primjereno, prirodu bolesti koja će se liječiti.
English: In addition, a study performed at the Micro Therapeutic Research Labs Pvt. Ltd site in Coimbatore was inspected.
Croatian: Osim toga, proveden je inspekcijski nadzor ispitivanja provedenog u tvrtki Micro Therapeutic Research Labs Pvt.
English: For the Hydrokortison Alternova (Orifarm) and Hydrokortison BBS marketing authorisation applications, the CHMP concluded that the Member State(s) will have to consider whether the bridging between the proposed product and the medicinal products described in the literature as par Annex I of Directive 2001/83/EC is sufficiently established as the applications relate to Article 10a of Directive 2001/83/EC (‘Well-established use').
Croatian: Za zahtjeve za izdavanje odobrenja za stavljanje u promet lijekova Hydrokortison Alternova (Orifarm) i Hydrokortison BBS, CHMP je utvrdio da će država članica (ili više njih) morati razmotriti je li dostatno utvrđena veza između predloženog lijeka i lijeka navedenog u literaturi prema Prilogu I.
English: Some of these authorised medicinal products may be considered critical by the individual EU Member States on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Croatian: Pojedine države članice mogu neke od navedenih lijekova smatrati izrazito važnima na temelju ocjene potencijalno nezadovoljene medicinske potrebe, uzimajući u obzir dostupnost primjerenih alternativnih lijekova u dotičnoj državi članici (ili više njih) i, prema potrebi, prirodu bolesti koja će se liječiti.
English: b. Marketing authorisation applications for which data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product do not satisfy the criteria for authorisation, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 26 of Directive 2001/83/EC.
Croatian: Zahtjevi za odobrenje za stavljanje lijeka u promet za koje nisu dostavljeni podatci ili obrazloženja ili za koje podatci ili obrazloženja o bioekvivalenciji prema mišljenju CHMP-a nisu dostatni za utvrđivanje bioekvivalencije u odnosu na referentni lijek odobren u EU-u ne ispunjavaju kriterije za izdavanje odobrenja s obzirom na to da su određeni podatci koji potkrepljuju odobrenja za stavljanje lijeka u promet netočni te da se omjer koristi i rizika ovih odobrenja za stavljanje lijeka u promet ne smatra povoljnim u skladu s člankom 26. Direktive 2001/83/EZ.
English: c. Marketing authorisations for medicinal products for which the bioequivalence vis-à-vis the EU reference medicinal product has been established should be maintained, as the benefit risk balance of these marketing authorisation is considered favourable.
Croatian: Odobrenja za stavljanje lijeka u promet za koja je bioekvivalencija utvrđena u odnosu na referentni lijek odobren u EU-u treba zadržati jer se smatra da je omjer koristi i rizika tih odobrenja za stavljanje lijeka u promet povoljan.
English: Critical findings were identified following inspections to check compliance with Good clinical practice (GCP) by the Austrian Federal Office for Safety in Healthcare (BASG) and the Health Care Inspectorate of the Netherlands (IGZ) in February 2016 at Micro Therapeutic Research Labs Pvt. Ltd, Chennai, India.
Croatian: Savezni ured za sigurnost u zdravstvu (BASG) u Austriji i Inspektorat za zdravstvenu zaštitu (IGZ) u Nizozemskoj utvrdili su ključne nalaze inspekcija za provjeru sukladnosti s dobrom kliničkom praksom (GCP) provedenih u tvrtki Micro Therapeutic Research Labs Pvt.
English: • The Committee concluded that, for both marketing authorisations and marketing authorisation applications where there was alternative data to establish bioequivalence vis-à-vis the EU reference medicinal product the benefit-risk balance is considered favourable.
Croatian: • Odbor je zaključio da se omjer koristi i rizika smatra povoljnim za odobrenja za stavljanje lijeka u promet i zahtjeve za odobrenje za stavljanje lijeka u promet ako su postojali alternativni podatci s pomoću kojih se utvrdila bioekvivalencija u odnosu na referentni lijek odobren u EU-u.
English: Should during this period the EU Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation shall apply.
Croatian: Ako tijekom tog razdoblja država članica (ili više njih) zaključi da lijek više nije izrazito važan, primjenjuje se obustava dotičnog odobrenja za stavljanje lijeka u promet.
English: In the absence of the demonstration of bioequivalence vis-à-vis the EU reference medicinal product, the requirements of Article 10 of Directive 2001/83/EC cannot be considered fulfilled, the efficacy and safety of the concerned medicinal products cannot be established, hence the benefit-risk balance cannot be considered positive.
Croatian: Direktive 2001/83/EZ ne mogu se smatrati ispunjenima te se djelotvornost i sigurnost navedenih lijekova ne može se utvrditi te se stoga omjer koristi i rizika ne može smatrati pozitivnim.
English: For the suspension of the marketing authorisations to be lifted the MAH shall demonstrate bioequivalence data vis-à-vis a valid EU reference medicinal product based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Croatian: Kako bi se ukinula obustava odobrenja za stavljanje lijeka u promet, nositelj odobrenja za stavljanje lijeka u promet mora dokazati bioekvivalenciju u odnosu na referentni lijek, odobrenu u EU-u na temelju relevantnih podataka, u skladu sa zahtjevima iz članka 10.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that: a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
Croatian: Potrebno je obustaviti odobrenja za stavljanje u promet lijekova za koje nisu dostavljeni podatci ili obrazloženja o bioekvivalenciji ili za koje podatci i obrazloženja o bioekvivalenciji prema mišljenju CHMP-a nisu dostatni za utvrđivanje bioekvivalencije u odnosu na referentni lijek odobren u EU-u s obzirom na to da su određeni podatci koji potkrepljuju odobrenja za stavljanje lijeka u promet netočni te da se omjer koristi i rizika tih odobrenja za stavljanje lijeka u promet ne smatra povoljnim u skladu s člankom 116.
English: Scientific conclusions
Croatian: c.
English: d. Bioequivalence vis-à-vis a valid EU reference medicinal product has been established for marketing authorisation applications listed in Annex Ia of the CHMP Opinion.
Croatian: Za zahtjeve za odobrenja za stavljanje lijeka u promet navedene u Prilogu I.a mišljenja CHIMPa utvrđena je bioekvivalencija u odnosu na valjani referentni lijek odobren u EU-u.
English: Content
Croatian: Sastav
English: The tablets should be swallowed with a little water.
Croatian: Tablete treba progutati s malo vode.
English: Week 1 Week 2 Week 3 Week 4
Croatian: Tjedan 1 Tjedan 2 Tjedan 3 Tjedan 4
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati lijek jer ona sadrži Vama važne podatke.
English: Once daily.
Croatian: Jednom dnevno.
English: Not known (frequency cannot be estimated from the available data):
Croatian: Nepoznate učestalosti (učestalost se ne može procijeniti iz raspoloživih podataka):
English: Ergates Industrial Area, 2643 Nicosia Cyprus
Croatian: Ergates Industrial Area, 2643 Nicosia Cipar
English: Date of first authorisation: 04 December 2013 Date of latest renewal: 3rd August 2018
Croatian: Datum prvog odobrenja: 04-12-2013 Datum posljednje obnove: 3. kolovoza 2018
English: Memantine Accord should be administered once a day and should be taken at the same time every day.The film-coated tablets can be taken with or without food.
Croatian: Memantin Accord se mora primjenjivati jednom dnevno i potrebno ga je uzimati svaki dan u isto vrijeme.Filmom obložene tablete mogu se uzimati sa ili bez hrane.
English: Memantine Accord is not recommended for children and adolescents under the age of 18 years.
Croatian: Memantin Accord se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Croatian: Posljedično tome, dostupni su samo ograničeni podaci te je potrebno pažljivo nadzirati bolesnike s navedenim stanjima.
English: if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Croatian: ako ste alergični na memantinklorid ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Memantine is eliminated in a monoexponential manner with a terminal t½ of 60-100hours.
Croatian: Memantin se eliminira monoeksponencijalno s terminalnim t½ od 60 do 100 sati.
English: The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7-9 (see section 4.4).
Croatian: Brzina bubrežne eliminacije memantina u uvjetima alkalnog urina može biti smanjena za faktor od 7 do 9 (vidjeti dio 4.4).
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10-40 mg.
Croatian: Ispitivanja na dobrovoljcima pokazala su linearnu farmakokinetiku u rasponu doza od 10 do 40 mg.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: One tablet daily.
Croatian: Jedna tableta dnevno.
English: Do not take Memantine Accord:
Croatian: Nemojte uzimati Memantin Accord:
English: In particular, Memantine Accord may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Croatian: Posebice, Memantin Accord može promijeniti učinak sljedećih lijekova, te će liječnik možda morati prilagoditi njihovu dozu:
English: If you go into hospital, let your doctor know that you are taking Memantine Accord.
Croatian: Ako dođete u bolnicu, obavijestite svog liječnika da uzimate Memantin Accord.
English: Continue to take Memantine Accord as long as it is of benefit to you.
Croatian: Nastavite uzimati Memantin Accord onoliko dugo koliko od njega imate koristi.
English: If you find you have forgotten to take your dose of Memantine Accord, wait and take your next dose at the usual time.
Croatian: Ako ustanovite da ste zaboravili uzeti dozu lijeka Memantin Accord, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
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: Memantine Accord is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Croatian: Primjena lijeka Memantin Accord kod djece mlađe od 18 godina se ne preporučuje zbog nedostatka podataka o sigurnosti i djelotvornosti.
English: In general, taking too much Memantine Accord should not result in any harm to you.
Croatian: Općenito, uzimanje previše lijeka Memantin Accord ne bi Vam trebalo naškoditi.
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 imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Croatian: U ekstremnom 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: The Memantine Accord treatment initiation pack is only to be used for the beginning of the treatment with Memantine Accord.
Croatian: Pakovanje lijeka Memantin Accord za početak liječenja se treba koristiti samo na početku liječenja lijekom Memantin Accord.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se očekuje da prijave sve sumnje na nuspojave prijave putem nacionalnog sustava prijavljivanja navedenog u Dodatku V.
English: Talk to your doctor or pharmacist before taking Memantine Accord if you have a history of epileptic seizures if you have recently experienced a myocardial infarction (heart attack), or if you are suffering rom congestive heart failure or from an uncontrolled hypertension (high blood pressure).
Croatian: Posavjetujte se sa svojim liječnikom ili ljekarnikom prije početka uzimanja lijeka Memantin Accord 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: The tablets can be divided into equal doses.
Croatian: Tablete se mogu razdijeliti na jednake doze.
English: What Memantine Accord is and what it is used for 2.
Croatian: Što je Memantin Accord i za što se koristi 2.
English: Not known Psychotic reactions2
Croatian: Nepoznato psihotične reakcije2
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, prema sljedećim skupinama učestalosti: 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: Other medicines and Memantine Accord
Croatian: Drugi lijekovi i Memantin Accord
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactosemalabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: PVC/PE/PVDC-aluminium blister
Croatian: PVC/PE/PVDC-aluminijski blister
English: If you take more Memantine Accord than you should
Croatian: Ako uzmete više lijeka Memantin Accord nego što ste trebali
English: If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, molimo obratite se svom liječniku prije uzimanja ovog lijeka.
English: What Memantine Accord looks like and contents of the pack
Croatian: Kako Memantin Accord izgleda i sadržaj pakiranja
English: The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine Accord dose during the first 3 weeks of treatment.
Croatian: Preporučena doza za liječenje od 20 mg dnevno postiže se postupnim povećanjem doze lijeka Memantin Accord tijekom prva 3 tjedna liječenja.
English: • Periodic safety update reports
Croatian: • Periodična izvješća o neškodljivosti
English: What you need to know before you take Memantine Accord 3.
Croatian: Što morate znati prije nego počnete uzimati Memantin Accord 3.
English: Memantine Accord should be administered orally once a day.
Croatian: Memantin Accord treba primjenjivati na usta jedanput na dan.
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 incidencijom 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: From the fourth week on, the usual dose is 2tablets once a day (1 x 20 mg).
Croatian: Od četvrtog tjedna nadalje uobičajena doza je 2 tablete jedanput na dan (1 x 20 mg).
English: Additional for 15 mg and 20 mg film-coated tablets Iron oxide yellow and red (E 172)
Croatian: Dodatno kod 15 mg i 20 mg filmom obloženih tableta željezov oksid, žuti i crveni (E 172)
English: The recommended dose of Memantine Accord for adults and older people is 20 mg once a day.
Croatian: Preporučena doza lijeka Memantin Accord za odrasle i starije osobe je 20 mg jednom dnevno.
English: Balance disorders Uncommon Gait abnormal Very rare
Croatian: Često poremećaji ravnoteže Manje često abnormalni hod Vrlo rijetko napadaji
English: 319 Pinner Road North Harrow Middlesex, HA1 4HF United Kingdom
Croatian: 319 Pinner Road North Harrow Middlesex, HA1 4HF Velika Britanija
English: Very Rare (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetke (mogu se javiti kod do 1 na 10 000 osoba):
English: Furthermore, memantine 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, memantin ima blagi do umjereni utjecaj na sposobnost upravljanja vozilima i rada na strojevima pa ambulantne bolesnike treba upozoriti da na to obrate posebnu pozornost.
English: Accord Healthcare Limited Sage house, 319 Pinner road North Harrow, Middlesex, HA1 4HF United Kingdom
Croatian: Accord Healthcare Limited Sage house, 319 Pinner road North Harrow, Middlesex, HA1 4HF Velika Britanija
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilacijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2.
English: What Memantine Accord is and what it is used for
Croatian: Što je Memantin Accord i za što se koristi
English: If you forget to take Memantine Accord
Croatian: Ako ste zaboravili uzeti Memantine Accord
English: Standard clinical procedures to remove active substance material, e.g. gastric lavage, carbomedicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
Croatian: Treba koristiti standardne kliničke postupke za uklanjanje djelatne tvari, npr. ispiranje želuca, primjenu medicinskog ugljena (prekidanje potencijalne enterohepatičke recirkulacije), zakiseljavanje urina te forsiranu diureza, kako je prikladno.
English: • Inflammation of the pancreas, inflammation of the liver and psychotic reactions
Croatian: • upala gušterače, upala jetre i psihotične reakcije
English: What you need to know before you take Memantine Accord
Croatian: Što morate znati prije nego počnete uzimati Memantin Accord
English: Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: 7 x Memantine Accord 5 mg
Croatian: Svako pakiranje s 28 filmom obloženih tableta za plan liječenja za 4 tjedna sadržava: 7 x Memantin Accord 5 mg
English: When daily doses of 5-30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated.
Croatian: Pri primjeni dnevnih doza od 5 do 30 mg izračunata je aritmetička sredina omjera cerebrospinalni likvor (CSL)/serum od 0,52.