FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that none of the studies was designed to address the specific indication under question (symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)), and that the data is further weakened by publication biases and changes in the understanding of proper criteria for current diagnoses.
Croatian: CHMP je napomenuo da niti jedno ispitivanje nije dizajnirano tako da obuhvati predmetnu specifičnu indikaciju (simptomatsko liječenje kroničnog patološkog kognitivnog i neurosenzoričkog oštećenja u starijih osoba (isključujući Alzheimerovu bolest i druge demencije)), te da su podaci još više nepouzdani uslijed pristranosti publikacija i izmjena u razumijevanju ispravnih kriterija za trenutne dijagnoze.
English: Overall summary of the scientific evaluation of nicergoline containing medicinal products (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene lijekova koji sadrže nicergolin (vidjeti Dodatak I)
English: However, the CHMP considered whether some of these studies could be used in support of the indication “ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)”.
Croatian: No, CHMP je razmatrao mogu li se pojedina ispitivanja iskoristiti u prilog indikacije „pomoćno liječenje intermitentne klaudikacije u slučaju simptomatske bolesti perifernih arterija (PAOD stadij II)“.
English: • The variation to the terms of the marketing authorisation for nicergoline containing medicinal products referred to in Annex I, to delete the below indications (specific wording of the indication may vary from product to product and from country to country) as well as any relevant reference to these indications, when there are other therapeutic indications approved as part of their marketing authorisation:
Croatian: I kako bi se obrisale niže navedene indikacije (specifična formulacija indikacija može varirati od proizvoda do proizvoda i od države do države) kao i bilo koja relevantna referenca na ove indikacije, ako postoje druge terapijske indikacije odobrene kao dio njihovog odobrenja za stavljanje lijeka u promet:
English: • The Committee considered that the benefit-risk balance of nicergoline containing products:
Croatian: • Povjerenstvo smatra da omjer koristi i rizika lijekova koji sadrže nicergolin:
English: − Acute retinopathies of vascular origin.
Croatian: − akutne retinopatije vaskularnog porijekla.
English: These data were considered insufficient by the CHMP to conclude on a beneficial efficacy of nicergoline in the prophylaxis of migraine headache.
Croatian: CHMP smatra ove podatke nedostatnima za donošenje zaključka o blagotvornom djelovanju nicergolina na profilaksu mingrenske glavobolje.
English: The CHMP concluded that, as result, no conclusion on efficacy of nicergoline as “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)” can be drawn from the data provided.
Croatian: CHMP smatra da se, kao rezultat istog, iz dostavljenih podataka ne može donijeti nikakav zaključak o djelotvornosti nicergolina kao „simptomatskog liječenja kroničnog patološkog kognitivnog i neurosenzoričkog oštećenja u starijih osoba (isključujući Alzheimerovu bolest i druge demencije)“.
English: • Adverse drug reaction with a substance marketed for a long time is generally less reported
Croatian: • se nuspojave s tvari stavljenom u promet za dugoročno uzimanje načelno rjeđe prijavljuju,
English: − Is not favourable for prophylaxis of migraine headache.
Croatian: − nije povoljan za profilaksu mingrenske glavobolje.
English: − Prophylaxis of migraine headache.
Croatian: − profilaksa mingrenske glavobolje.
English: The Committee concluded that the benefit-risk balance of nicergoline containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia), for ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II), for ancillary treatment of Raynaud's syndrome, for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin, for acute retinopathies of vascular origin and for prophylaxis of migraine headache.
Croatian: Direktive 2001/83/EC za simptomatsko liječenje kroničnog kognitivnog i neurosenzoričkog oštećenja u starijih osoba (isključujući Alzheimerovu bolest i druge demecije), za pomoćno liječenje intermitentne klaudikacije u slučaju simptomatske bolesti perifernih arterija (PAOD stadij II), za pomoćno liječenje Raynaudovog sindroma, za pomoćno liječenje smanjivanja oštrine vida i poremećaja vidnoga polja vjerojatno vaskularnog porijekla, za akutne retinopatije vaskularnog porijekla i za profilaksu mingrenske glavobolje.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations or suspension of the marketing authorisations, as applicable, taking into consideration the approved indications for each product
Croatian: Dodatak II Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet ili suspenziju odobrenja za stavljanje lijeka u promet,
English: − Is not favourable for ancillary treatment of Raynaud's syndrome.
Croatian: − nije povoljan za pomoćno liječenje Raynaudovog sindroma.
English: − Is not favourable for ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II).
Croatian: − nije povoljan za pomoćno liječenje intermitentne klaudikacije u slučaju simptomatske bolesti perifernih arterija (PAOD stadij II).
English: − Is not favourable for acute retinopathies of vascular origin.
Croatian: − nije povoljan za akutne retinopatije vaskularnog porijekla.
English: For the indication “ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)” no data were submitted and as a result was considered as unsupported by the CHMP.
Croatian: Podaci nisu dostavljeni za indikaciju „pomoćno liječenje intermitentne klaudikacije u slučaju simptomatske bolesti perifernih arterija (PAOD stadij II)“, te slijedom toga CHMP smatra ovu indikaciju nepodržanom.
English: • Prophylaxis of migraine headache
Croatian: • profilaksa mingrenske glavobolje
English: − Ancillary treatment of Raynaud's syndrome.
Croatian: − pomoćno liječenje Raynaudovog sindroma.
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Croatian: − simptomatsko liječenje kroničnog patološkog kognitivnog i neurosenzoričkog oštećenja u starijih osoba (isključujući Alzheimerovu bolest i druge demencije).
English: The MAH further provided information on six clinical comparative studies in senile cerebral insufficiency and a short description of a non-comparative study and three observational studies in support of the efficacy of nicergoline in a specific indication “symptomatic treatment of mild cognitive impairment of vascular origin in the elderly”.
Croatian: Nadalje, nositelj odobrenja dostavio je u prilog djelotvornosti nicergolina za specifičnu indikaciju „simptomatsko liječenje blagog kognitivnog oštećenja vaskularnog porijekla u starijih osoba“informaciju o šest kliničkih komparativnih ispitivanja senilne cerebralne insuficijencije i kratak opis nekomparativnog ispitivanja te tri opservacijska ispitivanja.
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Croatian: − pomoćno liječenje smanjenja oštrine vida i poremećaja vidnoga polja za koje se pretpostavlja da su vaskularnog porijekla.
English: − Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Croatian: − nije povoljan za simptomatski liječenje kroničnog kognitivnog i neurosenzoričkog oštećenja u starijih osoba (isključujući Alzheimerovu bolest i druge demecije).
English: − Is not favourable for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Croatian: − nije povoljan za pomoćno liječenje smanjivanja oštrine vida i poremećaja vidnoga polja vjerojatno vaskularnog porijekla.
English: • The suspension of the marketing authorisation for nicergoline containing medicinal products referred to in Annex I in the event that no other indications are approved as part of their marketing authorisation.
Croatian: • Suspenzija odobrenja za stavljanje lijeka u promet za lijekove koji sadrže nicergolin, a koji su navedeni u Dodatku
English: The referral started on 15 May 2013.
Croatian: Postupak arbitraže započeo je 15. svibnja 2013.
English: International non-proprietary name (INN): enrofloxacin
Croatian: Međunarodno nezaštićeno ime (INN): enrofloksacin
English: Written explanations were provided by some of the applicants and marketing authorisation holders by 30 September 2013 and 3 February 2014.
Croatian: Neki predlagatelji i nositelji odobrenja podnijeli su pisana objašnjenja do 30. rujna 2013. i 3. veljače 2014. godine.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Croatian: Na temelju procjene trenutno dostupnih podataka, CVMP je smatrao da ukupni profil koristi i rizika za te proizvode ostaje pozitivan i podložan promjenama u informacijama o proizvodu.
English: The CVMP was requested to consider what indications, dosage regimens and durations of treatments should be applied for the products concerned in order to ensure efficacy and target animal safety and to minimise the development of antimicrobial resistance, taking into account the available data.
Croatian: Od CVMP-a se zahtijevalo da razmotri koje indikacije, režime doziranja i trajanja liječenja treba primijeniti za dotične proizvode kako bi se osigurala djelotvornost proizvoda i sigurnost ciljnih životinja te da se umanji razvoj antimikrobne rezistencije, uzimajući u obzir dostupne podatke.
English: The CVMP was also requested to consider what withdrawal periods should be applied to the concerned products for each target species.
Croatian: Od CVMP-a se također zahtijevalo da razmotri koje karencije treba primijeniti na dotične proizvode za svaku ciljnu vrstu.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Croatian: Znanstveni zaključci nalaze se u Prilogu II. skupa s izmjenama u sažetku opisa svojstava VMP-a, označavanju i pakiranju u Prilogu III.
English: The Committee appointed C. Muñoz Madero as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Croatian: Muñoz Madera kao procjenitelja i M.
English: On 22 April 2013, Spain presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products.
Croatian: Španjolska je 22. travnja 2013. godine podnijela Agenciji obavijest o arbitraži u skladu s člankom 35. Direktive 2011/82/EZ u vezi lijekova Baytril 2,5% injekcijske otopine, Baytril 5% injekcijske otopine, Baytril 10% injekcijska otopine i pridruženih naziva te povezanih veterinarsko-medicinskih proizvoda.
English: Opinion following an Article 351 referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products
Croatian: Baytril 2,5% injekcijsku otopinu, Baytril 5% injekcijsku otopinu, Baytril 10% injekcijsku otopinu i njihove povezane nazive, kao i povezane veterinarsko-medicinske proizvode
English: Opinion following an Article 350F referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products
Croatian: Mišljenje nakon arbitraže u skladu s člankom 35.0F za Baytril 2,5% injekcijsku otopinu,
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/122)
Croatian: Ishod postupka u skladu s člankom 34. Direktive 2001/82/EZ (EMEA/V/A/122)
English: 8 May 2018
Croatian: 8. svibnja 2018.
English: Girolan (and its associated name Apralan) is marketed in Denmark, France, Germany, Ireland, Italy, The Netherlands, Portugal, Spain and the United Kingdom.
Croatian: Girolan (i njegovo pridruženo ime Apralan) stavljen je u promet u Danskoj, Francuskoj, Njemačkoj, Irskoj, Italiji, Nizozemskoj, Portugalu, Španjolskoj i Ujedinjenoj Kraljevini.
English: The European Commission issued a decision on 8 May 2018.
Croatian: Europska komisija donijela je odluku 8. svibnja 2018.
English: Girolan is authorised in the EU via national procedures.
Croatian: VMP Girolan odobren je u EU-u u okviru nacionalnih postupaka.
English: Questions and answers on Girolan and its associated name Apralan EMA/295529/2018
Croatian: Pitanja i odgovori o VMP-u Girolan i njegovu pridruženom imenu Apralan EMA/295529/2018
English: The amended product information is available on the 'All documents' tab.
Croatian: Izmijenjene informacije o VMP-u dostupne su u kartici „All documents” (Svi dokumenti).
English: Questions and answers on Girolan and its associated name Apralan
Croatian: Pitanja i odgovori o VMP-u Girolan i njegovu pridruženom imenu Apralan
English: Spain noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Girolan (and its associated name Apralan) is marketed.
Croatian: Španjolska je primijetila da u državama članicama postoje odstupanja u načinu na koji se veterinarsko-medicinski proizvod može primjenjivati, kao što je uočeno u razlikama u informacijama o VMP-u u zemljama u kojima je VMP Girolan (i njegovo pridruženo ime Apralan) stavljen u promet.
English: On 15 February 2018, the European Medicines Agency (the Agency) completed a review of Girolan and its associated name, Apralan.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 15. veljače 2018. ocjenjivanje VMP-a Girolan i njegova pridruženog imena Apralan.
English: Girolan is a veterinary medicinal product available as a powder for use in drinking water/milk containing apramycin sulfate as the active substance.
Croatian: Girolan je veterinarsko-medicinski proizvod dostupan u obliku praška za primjenu u vodi za piće/mlijeku koji sadržava djelatnu tvar apramicin sulfat.
English: What is Girolan and its associated name Apralan?
Croatian: Što je Girolan i njegovo pridruženo ime Apralan?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for the aforementioned product in the European Union (EU).
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija o VMP-u (sažetka opisa svojstava VMP-a, označivanja i uputa o VMP-u) za navedeni proizvod u Europskoj uniji (EU).
English: Why was Girolan and its associated name Apralan reviewed?
Croatian: Zašto su Girolan i njegovo pridruženo ime Apralan ponovno ocjenjivani?
English: On 24 June 2016, Spain referred the matter to the CVMP in order to harmonise the product information for Girolan (and its associated name Apralan) in the EU.
Croatian: Španjolska je 24. lipnja 2016. uputila predmet CVMP-u radi usklađivanja informacija o VMP-u za VMP Girolan (i njegovo pridruženo ime Apralan) u EU-u.
English: Based on the evaluation of the currently-available data, the CVMP concluded by majority that the product information for Girolan and its associated name Apralan should be harmonised across the EU.
Croatian: CVMP je na temelju evaluacije trenutačno dostupnih podataka većinom glasova zaključio da se informacije o VMP-u za Girolan i njegovo pridruženo ime Apralan moraju uskladiti na razini EU-a.
English: enterica serovar Dublin (Salmonella Dublin) in pre-ruminant calves; treatment of colibacillosis caused by Escherichia coli in chickens and treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli in rabbits.
Croatian: VMP Girolan indiciran je za liječenje bakterijskog enteritisa prouzročenog bakterijom Escherichia coli u svinja; liječenje bakterijskog enteritisa prouzročenog bakterijom Escherichia coli i kliničkih izbijanja bolesti prouzročenih bakterijom Salmonella enterica subsp. enterica serovar Dublin (Salmonella Dublin) u predpreživačke teladi; liječenje kolibakciloze prouzročene bakterijom Escherichia coli u pilića te liječenje i metafilaksu bakterijskog enteritisa prouzročenog bakterijom Escherichia coli u zečeva.
English: SE = standard error.
Croatian: SE = standardna pogreška.
English: During the injection you will hear 2 loud clicks.
Croatian: Tijekom injekcije čut ćete 2 glasna klika.
English: Erelzi can be taken with or without food or drink.
Croatian: Erelzi se može primjenjivati sa ili bez hrane ili pića.
English: DO NOT USE
Croatian: NEMOJTE KORISTITI
English: READY TO BE USED
Croatian: SPREMNO ZA UPORABU
English: • Educational materials will be constantly updated for further improvements
Croatian: • edukacijski materijal stalno će se ažurirati novim poboljšanjima
English: • Wash your hands with soap and hot water.
Croatian: • Operite ruke sapunom i vrućom vodom.
English: The syringe cannot be re-used.
Croatian: Štrcaljka se ne može ponovno upotrijebiti.
English: Erelzi is a medicine that is made from two human proteins.
Croatian: Erelzi je lijek napravljen od dva ljudska proteina.
English: If you use more Erelzi than you should
Croatian: Ako primijenite više Erelzija nego što ste trebali
English: When you are ready to use the syringe, open the blister and wash your hands thoroughly with soap and water.
Croatian: Kada ste spremni upotrijebiti štrcaljku, otvorite blister i temeljito operite ruke sapunom i vodom.
English: Component of a multipack, cannot be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se pojedinačno prodati.
English: Other medicines and Erelzi
Croatian: Drugi lijekovi i Erelzi
English: Caregivers and healthcare professionals only:
Croatian: Samo za njegovatelje i zdravstvene radnike:
English: Educational materials
Croatian: Edukacijski materijal
English: • Never try to re-use your pen.
Croatian: • Nikada nemojte pokušavati ponovno upotrijebiti svoju brizgalicu.
English: Use in adult patients (aged 18 years or over)
Croatian: Primjena u odraslih bolesnika (u dobi od 18 ili više godina)
English: • Patient´s name, Doctor´s name and phone number
Croatian: • ime pacijenta, ime i telefonski broj liječnika
English: This appearance is normal for Erelzi.
Croatian: Ovaj izgled je normalan za Erelzi.
English: Talk to your doctor before taking Erelzi.
Croatian: Obratite se svom liječniku prije nego uzmete lijek Erelzi.
English: 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: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1).
Croatian: Kontinuirana terapija dulja od 24 tjedna može biti prikladna u nekih odraslih bolesnika (vidjeti dio 5.1.).
English: Be careful not to touch the needle guard wings before use.
Croatian: Pazite da ne dodirujete krilca štitnika igle prije uporabe.
English: • Free lines for adding additional information:
Croatian: • prazni retci za dodatne informacije:
English: You must keep holding the pen firmly against your skin until you see a green indicator fill the window and stop moving.
Croatian: Morate i dalje držati brizgalicu čvrsto uz kožu dok ne vidite da je zeleni indikator ispunio prozorčić i prestao se micati.
English: What Erelzi looks like and contents of the pack
Croatian: Kako Erelzi izgleda i sadržaj pakiranja
English: For the safety and health of you and others, needles and used syringes must never be re-used.
Croatian: Radi zdravlja i sigurnosti kako Vas tako i drugih osoba, igle i upotrijebljene štrcaljke ne smiju se nikada ponovno koristiti.
English: • Information that Erelzi can increase risk for getting serious infection:
Croatian: • informacije o tome da Erelzi može povećati rizik obolijevanja od ozbiljnih infekcija:
English: • Information regarding the need for evaluation on tuberculosis (TB)
Croatian: • informacije o potrebi za pregledom s obzirom na tuberkulozu
English: Never leave the syringe lying around where others might tamper with it.
Croatian: Nikada nemojte ostavljati štrcaljku negdje gdje bi je drugi mogli dirati.
English: If you received Erelzi during pregnancy, your baby may have a higher risk of getting an infection.
Croatian: Ako primite Erelzi tijekom trudnoće, Vaše dijete može imati veći rizik za dobivanje infekcije.
English: You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
Croatian: Možete iskoristiti i donji dio trbuha, ali ne područje 5 centimetara oko pupka.
English: If you have psoriasis, you should NOT inject directly into any raised, thick,
Croatian: Ako imate psorijazu, NE smijete izravno ubrizgati u povišena,
English: Responses of patients with psoriasis in studies 2, 3 and 4
Croatian: ODGOVOR bolesnika sa psorijazom u ispitivanjima 2, 3 i 4
English: Hold the syringe finger flange as shown.
Croatian: Držite hvatište za prst na štrcaljki kako je prikazano.
English: Contact your pharmacist if the pen fails any of these checks.
Croatian: Obratite se svom ljekarniku ako brizgalica ne prođe bilo koju od ovih provjera.
English: It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis.
Croatian: Vrlo je važno da napomenete liječniku ako ste Vi ili dijete ikada imali tuberkulozu ili ste bili u bliskom dodiru s osobom koja je imala tuberkulozu.
English: In all these cases, return the entire product pack to the pharmacy.
Croatian: U svim tim slučajevima vratite cijelo pakiranje s lijekom u ljekarnu.
English: However, any of the above symptoms may indicate an allergic reaction to Erelzi, so you should seek immediate medical attention.
Croatian: Međutim, bilo koji od gore navedenih simptoma može upućivati na alergijsku reakciju na Erelzi, stoga je potrebno odmah zatražiti liječničku pomoć.
English: What Erelzi is and what it is used for
Croatian: Što je Erelzi i za što se koristi
English: Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor.
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vi ili dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove (uključujući anakinru, abatacept ili sulfasalazin), čak i one koje nije propisao liječnik.
English: 0.8 †, ϕ a: Patients who did not complete 12 months in the study were considered to be non-responders.
Croatian: 0,8†,φ a: Za bolesnike koji nisu završili 12 mjeseci u ispitivanju smatralo se da nisu odgovorili na terapiju.
English: • Signs of cancers: cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
Croatian: • Znakovi raka: rak može zahvatiti bilo koji dio tijela uključujući kožu i krv, a mogući znakovi ovise o vrsti i lokaciji raka.
English: A-6336 Langkampfen AUSTRIA
Croatian: A-6336 Langkampfen Austrija