FrancophonIA/ELRC3.0 huggingface dataset:
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria, which eventually kills them.
Croatian: Djeluje narušavajući stvaranje proteina koji je potreban bakteriji P. aeruginosa za stvaranje staničnih stjenki, što rezultira oštećivanjem bakterije, koja ih naposljetku ubija.
English: The active substance in Vantobra, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Croatian: Djelatna tvar u lijeku Vantobra, tobramicin, ubraja se u grupu antibiotika poznatih pod nazivom "aminoglikozidi".
English: The full EPAR and risk management plan summary for Vantobra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Vantobra nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Vantobra pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: However, Vantobra differs from Tobi by having a higher concentration of the active substance and is inhaled using a different type of nebuliser.
Croatian: No, Vantobra se razlikuje od lijeka Tobi većom koncentracijom djelatne tvari i inhalira se primjenom dugog tipa nebulizera.
English: Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule into a fine mist.
Croatian: Vantobranse inhalira pomoću uređaja Tolero nebulizer, koji konvertira otopinu u ampuli u finu maglicu.
English: Side effects with Vantobra are not common.
Croatian: Nuspojave lijeka Vantobra nisu uobičajene.
English: P. aeruginosa is a frequent cause of infections in cystic fibrosis
Croatian: P. aeruginosa je učestali uzročnik infekcija u bolesnika sa cističnom fibrozom.
English: The CHMP noted that inhaled tobramycin was the ‘gold standard' for treating P. aeruginosa infection in patients with cystic fibrosis and that some patients cannot use the dry powder form because they cannot tolerate it. For these patients Vantobra, which is inhaled as a solution from a nebuliser, would be a
Croatian: CHMP je zaključio da je inhalirani tobramicin zlatni standard za liječenje infekcije bakterijom P. aeruginosa u bolesnika sa cističnom fibrozom, te da pojedini bolesnici ne mogu koristiti suhi prašak budući da ga ne podnose.
English: Vantobra is available as a nebuliser solution in single-dose containers called ‘ampoules'.
Croatian: Vantobra je dostupan kao otopina za nebulizer u spremniku za jednu dozu naziva "ampule".
English: Tobramycin has been used for several years to treat P. aeruginosa infection in patients with cystic fibrosis and the applicant submitted data from the literature to support the use of Vantobra.
Croatian: Tobramicin je u primjeni nekoliko godina za potrebe liječenja infekcije izazvane bakterijom P. aeruginosa u bolesnika sa cističnom fibrozom, te je podnositelj zahtjeva dostavio podatke iz literature koji podržavaju primjenu lijeka Vantobra.
English: What benefits of Vantobra have been shown in studies?
Croatian: Koje su koristi lijeka Vantobra utvrđene u ispitivanjima?
English: The results of the study showed that Vantobra can be considered
Croatian: Rezultati ispitivanja pokazali su da se Vantobra može smatrati usporediv s lijekom Tobi.
English: There were no unusual safety findings with Vantobra.
Croatian: Nema neobičnih nalaza na području sigurne primjene vezanih uz lijek Vantobra.
English: For practical information about using Vantobra, patients should read the package leaflet or contact
Croatian: Praktične informacije o korištenju lijeka Vantobra pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Other incentives include:
Croatian: Ostali poticaji uključuju:
English: For information on administrative and procedural aspects of the pharmaceutical legislation
Croatian: Informacije o administrativnim i proceduralnim aspektima farmaceutskog zakonodavstva.
English: • employ less than 250 employees and have an annual turnover of not more than €50 million or an annual balance-sheet total of not more than €43 million.
Croatian: • imati manje od 250 zaposlenika i godišnji promet koji ne prelazi 50 milijuna EUR ili godišnju bilancu koja ne prelazi 43 milijuna EUR.
English: European Small Business Portal
Croatian: Europski portal za male poduzetnike (European Small Business Portal)
English: Research funding
Croatian: Financiranje istraživanja
English: Telephone +44 (0)20 3660 8787 Fax +44 (0)20 3660 5555
Croatian: Telefaks: +44 (0)20 3660 5555
English: Useful sources of information
Croatian: Korisni izvori informacija
English: The incentives offered by the SME Regulation apply to the human and veterinary sectors, and include:
Croatian: Poticaji koji se predviđaju Uredbom o MSP-ovima primjenjuju se na humani i veterinarski sektor i obuhvaćaju sljedeće:
English: To qualify for SME status, companies must meet the following criteria:
Croatian: Za dobivanje statusa MSP-a društva moraju zadovoljiti sljedeće kriterije:
English: This helps the sponsor to ensure that the appropriate studies are performed and maximises the chances of a successful marketing authorisation.
Croatian: Time se sponzoru pomaže u jamčenju izvođenja odgovarajućih istraživanja te se maksimalno povećava vjerojatnost uspješnog dobivanja odobrenja za stavljanje lijeka u promet.
English: Details on fees and fee reductions are available in the explanatory note on general fees payable to the European Medicines Agency8.
Croatian: Pojedinosti o naknadama i smanjenju naknada dostupne su u objašnjenju o općim naknadama koje se plaćaju Europskoj agenciji za lijekove8.
English: To maintain its SME status, the company should submit a completed declaration annually, based on its latest approved accounts.
Croatian: Da bi održalo status MSP-a društvo bi svake godine trebalo dostaviti popunjenu izjavu na temelju najnovijih odobrenih financijskih izvještaja.
English: With the aim of promoting innovation and development of new medicines by SMEs, the European Medicines Agency provides incentives for SMEs that are developing human or veterinary medicines1.
Croatian: U cilju promicanja inovacija i razvoja novih lijekova na razini MSP-ova Europska agencija za lijekove pruža poticaje MSP-ovima koji se bave razvojem lijekova za humanu ili veterinarsku primjenu.
English: Further information on the definition of an SME is available in the ‘User guide to the SME definition'2.
Croatian: Dodatne informacije o definiciji MSP-ova dostupne su u „Vodiču za korisnike o definiciji malih i srednjih poduzeća”
English: SMEs can benefit from direct regulatory assistance including SME briefing meetings, which aim to facilitate the interaction with the Agency and provide guidance on the EU regulatory framework and the tools to support innovation.
Croatian: MSP-ovi se mogu koristiti pogodnostima izravne regulatorne pomoći, što obuhvaća i pripremne sastanke za MSP-ove, čiji je cilj olakšavanje suradnje s Agencijom i pružanje smjernica o regulatornom okviru EU-a i alatima kojima se potiču inovacije.
English: Commission Recommendation 2003/361/EC defines micro, small and medium-sized enterprises.
Croatian: Mikro, mala i srednja poduzeća definirana su u Preporuci Komisije 2003/361/EZ.
English: Inspection (post-authorisation)
Croatian: Inspekcija (nakon izdavanja odobrenja)
English: SMEs are encouraged to seek scientific advice from the Agency early in the development process.
Croatian: MSP-ove se potiče da od Agencije zatraže znanstvene savjete u ranoj fazi razvoja.
English: • be established in the European Economic Area
Croatian: • imati poslovni nastan u Europskom gospodarskom prostoru (EGP-u)
English: • guidance on clinical data publication and provision of a free redaction tool license
Croatian: • smjernice o objavi kliničkih podataka i davanje besplatne licencije za alat za uređivanje.
English: 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2. ožujka 2017.
English: • fee incentives (see table)
Croatian: • poticaje u pogledu naknada (vidi tablicu)
English: Regulatory assistance
Croatian: Regulatorna pomoć
English: • assistance with translations of the product information required for the granting of an EU marketing authorisation
Croatian: • pružanje pomoći u vezi s prevođenjem informacija o lijeku za potrebe davanja odobrenja EU-a za stavljanje lijeka u promet
English: European Medicines Agency SME Office
Croatian: Europska agencija za lijekove
English: Inspection (pre-authorisation)
Croatian: Inspekcija (koji prethodi izdavanju odobrenja)
English: E-mail sme@ema.europa.eu
Croatian: E-pošta: sme@ema.europa.eu
English: 7For micro- and small-sized enterprises only
Croatian: Samo za mikropoduzeća i mala poduzeća.
English: Website www.ema.europa.eu
Croatian: Internetska stranica www.ema.europa.eu
English: Depending on the category of the enterprise, some or all of the headcount and financial data from other partner or linked enterprises may need to be counted when calculating whether the SME criteria are met.
Croatian: Ovisno o kategoriji poduzeća, pri izračunu u svrhu utvrđivanja jesu li zadovoljeni kriteriji da bi se društvo smatralo MSP-om možda će biti potrebno uračunati neke ili sve podatke o broju zaposlenih i financijske podatke partnerskih ili povezanih poduzeća.
English: A substantial fee reduction for scientific advice is available to SMEs (see table).
Croatian: MSP-ovima se stavlja na raspolaganje mogućnost znatnog smanjenja naknada za znanstvene savjete (vidi tablicu).
English: For information on the whole spectrum of EU policies, legislation, programmes and initiatives relevant to Europe's SMEs:
Croatian: Informacije o cijelom spektru politika, zakonodavstva, programa i inicijativa EU-a relevantnih za MSPove u Europi: http://ec.europa.eu/small-business/index_en.htm
English: 6Excluding parallel distribution
Croatian: Isključujući paralelni promet lijekova.
English: The applicant will receive an EMA-SME number once the SME status has been assigned.
Croatian: Podnositelju zahtjeva dostavit će se broj MSP-a iz registra Europske agencije za lijekove nakon što mu se dodijeli status MSP-a.
English: https://ec.europa.eu/programmes/horizon2020/
Croatian: Informacije o financijskim sredstvima EU-a: Cordis http://cordis.europa.eu/ Obzor 2020. (Horizon 2020) https://ec.europa.eu/programmes/horizon2020/
English: Addressing the needs of small and medium-sized enterprises (SMEs) and promoting innovation
Croatian: Ured za MSP-ove - rješavanje potreba mikro, malih i srednjih poduzeća (MSP-ova) te promicanje inovacija
English: The SME Office offers assistance to SMEs through dedicated personnel within the Agency.
Croatian: U Uredu za MSP-ove pomoć MSP-ovima pruža posebno posvećeno osoblje Agencije za ove potrebe.
English: Administrative services6
Croatian: Administrativne usluge
English: • organisation of info days and training sessions for SMEs
Croatian: • organizaciju dana otvorenih vrata i osposobljavanja za MSP-ove
English: • regulatory updates via SME Newsletters and mailings targeted to SMEs
Croatian: • obavješćivanje o regulatornim novostima u biltenima za MSP-ove i slanje informacija usmjerenih na MSP-ove e-poštom
English: The form 'Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME)3', available from the Agency's website, should be completed and submitted to the SME Office, together with the most recent annual accounts, information on ownership, and proof of establishment in the EEA.
Croatian: 3, koji je dostupan na internetskoj stranici Agencije, i dostaviti ga Uredu za MSP-ove, zajedno s najnovijim godišnjim financijskim izvještajem, podatcima o vlasništvu i dokazom o poslovnom nastanu u EGP-u.
English: • inclusion in the public SME register
Croatian: • upis u javni registar MSP-ova
English: 90% fee reduction and deferral 100% fee reduction for designated orphan products
Croatian: smanjenje naknade za 90 % i odgoda plaćanja naknade smanjenje naknade za 100 % za određene
English: For information on SME companies registered with the Agency
Croatian: Informacije o MSP-ovima upisanima u registar Agencije.
English: 4In the event of a negative outcome, where EMA scientific advice has been sought and followed 5Maximum Residue Limits
Croatian: U slučaju negativnog ishoda, ako je zatražen znanstveni savjet Europske agencije za lijekove i ako se postupalo u skladu s tim savjetom.
English: 1According to Commission Regulation (EC) No 2049/2005 2See European Commission/Growth/Publications 3See SME Office area at www.ema.europa.eu
Croatian: Vidi internetsku stranicu Europske komisije: European Commission/Growth/Publications Vidi dio o Uredu za MSP-ove na internetskoj stranici ema.europa.eu.
English: Establishment of MRLs5
Croatian: Utvrđivanje MRL-ova
English: 40% fee reduction for small or medium-sized enterprises during the first year after marketing authorisation
Croatian: Postupci nakon davanja odobrenja za stavljanje lijeka u promet, uključujući farmakovigilancijske aktivnosti oslobađanje mikropoduzeća od plaćanja naknade smanjenje naknade za 40 % malim i srednjim poduzećima smanjenje naknade za 100 % za određene lijekove koji se upotrebljavaju u liječenju rijetkih bolesti u prvoj godini nakon dobivanja odobrenja za stavljanje lijeka u promet
English: EMA user guide for SMEs3
Croatian: Korisnički vodič Europske agencije za lijekove za MSP-ove
English: 100% fee reduction for products granted eligibility to the Priority Medicines (PRIME) scheme
Croatian: Poticaj u pogledu naknade smanjenje naknade za 90 % za lijekove koji se upotrebljavaju u liječenju bolesti koje nisu rijetke smanjenje naknade za 100 % za određene lijekove koji se upotrebljavaju u liječenju rijetkih bolesti smanjenje naknade za 100 % za lijekove koji ispunjavaju uvjete za sudjelovanje u programu prioritetnih lijekova (PRIME)
English: Fee incentives
Croatian: Poticaji u pogledu naknada
English: SME Office
Croatian: Ured za MSP-ove
English: SME definition
Croatian: Definicija MSP-a
English: Post-authorisation procedures, including pharmacovigilance activities
Croatian: Licenca za Medicinski rječnik za regulatorne poslove (MedDRA)
English: SME public register3
Croatian: Javni registar MSP-ova
English: Fee exemption for micro-sized enterprises
Croatian: Postupak svrstavanja poduzeća u kategoriju MSP-a
English: Take only one tablet per day.
Croatian: Uzimajte samo jednu tabletu dnevno.
English: Date of first authorisation: 22 November 2018
Croatian: Datum prvog odobrenja: 22 studenoga 2018
English: See also section 2, “Warnings and precautions”.
Croatian: Također pogledajte dio 2 "Upozorenja i mjere opreza".
English: See also the beginning of section 4.
Croatian: Pogledajte također početak dijela 4.
English: Version 4.0 (NCI CTCAE v4).
Croatian: Verzija 4.0 (NCI CTCAE v4).
English: Alunbrig with food and drink
Croatian: Alunbrig s hranom i pićem
English: If you take more Alunbrig than you should
Croatian: Ako uzmete više Alunbriga nego što ste trebali
English: Symptoms may be similar to symptoms from lung cancer.
Croatian: Simptomi mogu biti slični simptomima raka pluća.
English: • sensitivity to sunlight
Croatian: • osjetljivost na sunčevo svjetlo
English: They are convex on the upper and lower side.
Croatian: Konveksne su s gornje i donje strane.
English: There are no available data on patients over 85 years of age.
Croatian: Za bolesnike starije od 85 godina nema dostupnih podataka.
English: Your doctor may adjust your dose according to your needs and this may require use of a 30 mg tablet to achieve the new recommended dose.
Croatian: Vaš liječnik može prilagoditi dozu prema Vašim potrebama, a to može zahtijevati uporabu tablete od 30 mg kako bi se postigla nova, preporučena doza.
English: The median duration of follow-up was 22.9 months.
Croatian: Medijan trajanja praćenja bio je 22,9 mjeseci.
English: The tablets should be swallowed whole and with water.
Croatian: Tablete treba progutati cijele i s vodom.
English: • Swallow the tablets whole, with a glass of water.
Croatian: • Tablete progutajte cijele, s čašom vode.
English: Treatment should continue as long as clinical benefit is observed.
Croatian: Liječenje treba nastaviti sve dok postoji klinička korist.
English: • Take Alunbrig once daily at the same time each day.
Croatian: • Alunbrig uzimajte jedanput dnevno, uvijek u isto vrijeme.
English: Day 8 to Day 28
Croatian: Dan 8 do Dan 28
English: Talk to your doctor before taking Alunbrig or during treatment if you have:
Croatian: Obratite se svom liječniku prije nego uzmete Alunbrig ili za vrijeme liječenja ako imate:
English: Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Croatian: Kategorije učestalosti su vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10) i manje često (≥ 1/1000 do < 1/100).
English: Study 101
Croatian: Ispitivanje 101
English: Age, body weight, and albumin concentrations
Croatian: Dob, tjelesna težina i koncentracije albumina
English: • increased blood clotting time shown by test of activated partial thromboplastin time
Croatian: • povećano vrijeme zgrušavanja krvi utvrđeno testom aktiviranog parcijalnog tromboplastinskog vremena
English: Thereafter, monitoring should be performed periodically.
Croatian: Nakon toga je potrebno periodičko praćenje.
English: Hypertension should be treated according to standard guidelines to control blood pressure.
Croatian: Hipertenziju treba liječiti prema standardnim smjernicama kako bi se kontrolirao krvni tlak.
English: Do not drive or use machines during treatment if such signs occur.
Croatian: Ne smijete voziti ili koristiti strojeve ako se jave takvi znakovi za vrijeme liječenja.
English: Alunbrig blocks the action of this protein and thus slows down the growth and spread of the cancer.
Croatian: Alunbrig blokira djelovanje tog proteina i tako usporava rast i širenje raka.
English: Alunbrig has not been studied in children or adolescents.
Croatian: Alunbrig nije ispitan u djece ili adolescenata.
English: Your doctor may need to adjust your treatment or stop Alunbrig temporarily or permanently.
Croatian: Vaš liječnik će možda trebati prilagoditi liječenje ili ga privremeno ili trajno prekinuti.
English: The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka provesti niže navedene mjere:
English: The median duration of peripheral neuropathy adverse reactions was 4.5 months, with a maximum duration of 28.7 months.
Croatian: Medijan trajanja periferne neuropatije bio je 4,5 mjeseci, uz maksimalno trajanje od 28,7 mjeseci.
English: What Alunbrig is and what it is used for What you need to know before you take Alunbrig How to take Alunbrig
Croatian: Što je Alunbrig i za što se koristi Što morate znati prije nego počnete uzimati Alunbrig Kako uzimati Alunbrig
English: Tell your doctor or pharmacist right away if you have taken more tablets than recommended.
Croatian: Odmah obavijestite liječnika ili ljekarnika ako ste uzeli više tableta nego što je preporučeno.
English: Do not change the dose without talking to your doctor.
Croatian: Ne smijete mijenjati dozu bez savjetovanja sa liječnikom.
English: What Alunbrig is and what it is used for
Croatian: Što je Alunbrig i za što se koristi
English: The blood-to-plasma concentration ratio is 0.69.
Croatian: Omjer koncentracije u krvi i plazmi iznosi 0,69.
English: If you are pregnant or think you may be pregnant or are planning to have a baby, talk to your doctor to discuss the risks of taking Alunbrig during pregnancy.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, razgovarajte sa svojim liječnikom o rizicima uzimanja lijeka Alunbrig tijekom trudnoće.
English: Avoid any grapefruit products during treatment as they may change the amount of brigatinib in your body.
Croatian: Za vrijeme liječenja izbjegavajte sve proizvode s grejpom jer oni mogu izmijeniti količinu brigatiniba u tijelu.
English: Available data cannot exclude potential excretion in human milk.
Croatian: Dostupni podaci ne mogu isključiti mogućnost izlučivanja u majčino mlijeko.
English: 90 mg once daily (first 7 days)
Croatian: 90 mg jedanput dnevno (prvih 7 dana)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.(c) stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: These effects were generally reversible during the non-dosing recovery period; however, effects in the eyes and testes were notable exceptions due to lack of recovery.
Croatian: Ovi učinci općenito su bili reverzibilni za vrijeme razdoblja oporavka bez primjene doze; ipak, učinci na oči i testise bili su značajne iznimke zbog nedostatka oporavka.
English: • inflammation of pancreas which may cause severe and persistent stomach pain, with or without nausea and vomiting (pancreatitis)
Croatian: • upala gušterače koja može uzrokovati tešku i stalnu bol u trbuhu, sa ili bez mučnine i povraćanja (pankreatitis)
English: Additionally, patients with central nervous system (CNS) metastases were included, provided they were neurologically stable and did not require an increasing dose of corticosteroids.
Croatian: uključeni su bolesnici s metastazama u središnjem živčanom sustavu (CNS), pod uvjetom da su bili neurološki stabilni i nisu trebali povećanu dozu kortikosteroida.
English: Randomisation was stratified by brain metastases (present, absent) and best prior response to crizotinib therapy (complete or partial response, any other response/unknown).
Croatian: Randomizacija je stratificirana po metastazama na mozgu (prisutne, odsutne) i najboljem prethodnom odgovoru na liječenje krizotinibom (kompletan ili djelomičan odgovor, bilo koji drugi odgovor/nepoznato).
English: Ask your doctor about the birth control methods that may be right for you.
Croatian: Posavjetujte se sa svojim liječnikom o metodama kontrole začeća koje su najbolje za Vas.
English: Median (months)
Croatian: Ukupno preživljenje Medijan (mjeseci)
English: Of these, three Grade 3 adverse reactions (2.7%) including macular oedema and cataract were reported.
Croatian: Među njima su prijavljene tri nuspojave 3. stupnja (2,7 %) uključujući makularni edem i kataraktu.
English: Antihyperglycaemic treatment should be initiated or optimised as needed.
Croatian: Po potrebi, treba započeti ili optimizirati antihiperglikemijsko liječenje.
English: Day 1 to Day 7
Croatian: Dan 1 do Dan 7
English: Alunbrig may also induce other enzymes and transporters (e.g., CYP2C, P-gp) via the same mechanisms responsible for induction of CYP3A (e.g., pregnane X receptor activation).
Croatian: Alunbrig također može inducirati druge enzime i transportere (npr. CYP2C, P-gp) putem istih mehanizama odgovornih za induciranje CYP3A (npr. aktiviranje pregnan X receptora).
English: What Alunbrig looks like and contents of the pack
Croatian: Kako Alunbrig izgleda i sadržaj pakiranja
English: It is unknown if brigatinib passes into breast milk and could potentially harm the baby.
Croatian: Nije poznato izlučuje li se brigatinib u majčino mlijeko i može li potencijalno naškoditi bebi.
English: reduce to 60 mg once daily permanently discontinue not applicable
Croatian: smanjiti na 60 mg jedanput dnevno trajno prekinuti nije primjenjivo
English: • reduced number of red blood cells (anaemia)
Croatian: • smanjen broj crvenih krvnih stanica (anemija)
English: Heart rate and blood pressure should be monitored regularly.
Croatian: Srčana frekvencija i krvni tlak se moraju redovito pratiti.
English: Most pulmonary adverse reactions were observed within the first 7 days of treatment.
Croatian: Većina nuspojava na plućima opažena je tijekom prvih 7 dana liječenja.