FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the applicant conducted a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above to determine whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Slovenian: Poleg tega je izvedel tudi študijo „biološke enakovrednosti“, v katero je bilo vključenih 58 bolnikov s cistično fibrozo, starih šest let in več, da bi ugotovil, ali zdravilo Vantobra vzpostavi podobno raven zdravilne učinkovine v telesu kot referenčno zdravilo Tobi.
English: For more information about treatment with Vantobra, read the package leaflet (also part of the EPAR) or contact
Slovenian: Za več informacij o zdravljenju z zdravilom Vantobra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali
English: P. aeruginosa is a frequent cause of infections in cystic fibrosis
Slovenian: Bakterija P. aeruginosa je pogost vzrok za okužbe pri bolnikih s cistično fibrozo.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily causing infections.
Slovenian: Cistična fibroza je dedna bolezen, pri kateri se v pljučih kopiči gosta sluz, ki omogoča lažjo rast bakterij, kar povzroča okužbe.
English: It is not intended to provide practical advice on how to use Vantobra.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: There were no unusual safety findings with Vantobra.
Slovenian: Pri zdravilu Vantobra niso zabeležili nobenih neobičajnih pojavov glede varnosti.
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.
Slovenian: Tobramicin se že več let uporablja za zdravljenje okužb z bakterijo P. aeruginosa pri bolnikih s cistično fibrozo, zato je predlagatelj v podporo uporabi zdravila Vantobra predložil podatke iz literature.
English: Vantobra therefore offers the advantage of better convenience and a higher likelihood of patients keeping to their treatment.
Slovenian: Zdravilo Vantobra je tako bolj priročno, zaradi česar je večja verjetnost, da bodo bolniki dosledni pri jemanju zdravila.
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
Slovenian: CHMP je opozoril, da je inhaliranje tobramicina „zlati standard“ za zdravljenje okužb z bakterijo P. aeruginosa pri bolnikih s cistično fibrozo in da ga nekateri bolniki ne morejo jemati v obliki suhega praška, saj ga ne prenašajo.
English: Vantobra is available as a nebuliser solution in single-dose containers called ‘ampoules'.
Slovenian: Zdravilo Vantobra je na voljo v obliki raztopine za nebulator v enoodmernih vsebnikih, imenovanih „ampule“.
English: For practical information about using Vantobra, patients should read the package leaflet or contact
Slovenian: Za praktične informacije o uporabi zdravila Vantobra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: However, Vantobra differs from Tobi by having a higher concentration of the active substance and is inhaled using a different type of nebuliser.
Slovenian: Zdravilo Vantobra se od zdravila Tobi razlikuje po tem, da ima višjo koncentracijo zdravilne učinkovine in da se
English: The results of the study showed that Vantobra can be considered
Slovenian: Rezultati študije so pokazali, da je zdravilo
English: Other incentives include:
Slovenian: Druge spodbude vključujejo:
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.
Slovenian: • zaposlujejo manj kot 250 oseb ter njihov letni promet ne presega 50 milijonov EUR oziroma njihova skupna letna bilančna vsota ne presega 43 milijonov EUR.
English: For information on administrative and procedural aspects of the pharmaceutical legislation
Slovenian: Za informacije o upravnih in postopkovnih vidikih farmacevtske zakonodaje.
English: 6Excluding parallel distribution
Slovenian: Razen vzporedne distribucije.
English: Regulatory assistance
Slovenian: Regulativno pomoč
English: Useful sources of information
Slovenian: Koristni viri informacij
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.
Slovenian: MSP so lahko delezna neposredne regulativne pomoči, vključno z informativnimi sestanki za MSP, katerih namen je spodbujati sodelovanje z agencijo in usmerjati podjetja glede regulativnega okvira EU in orodij za podporo inovativnosti.
English: Telephone +44 (0)20 3660 8787 Fax +44 (0)20 3660 5555
Slovenian: Faks: +44 (0) 20 3660 5555
English: This helps the sponsor to ensure that the appropriate studies are performed and maximises the chances of a successful marketing authorisation.
Slovenian: Sponzorju to pomaga zagotoviti, da se izvedejo ustrezne študije, kar lahko poveča verjetnost uspešne pridobitve dovoljenja za promet z zdravilom.
English: Details on fees and fee reductions are available in the explanatory note on general fees payable to the European Medicines Agency8.
Slovenian: Podrobnosti o pristojbinah in znižanjih pristojbin so na voljo v pojasnilu o splošnih pristojbinah, ki se plačujejo Evropski agenciji za zdravila
English: Post-authorisation procedures, including pharmacovigilance activities
Slovenian: Postopki po izdaji dovoljenja za promet, vključno z dejavnostmi farmakovigilance
English: Research funding
Slovenian: Financiranje raziskav
English: Addressing the needs of small and medium-sized enterprises (SMEs) and promoting innovation
Slovenian: Urad za MSP - Skrb za potrebe mikro, malih in srednje velikih podjetij (MSP) ter spodbujanje inovativnosti
English: • organisation of info days and training sessions for SMEs
Slovenian: • organizacijo informativnih dni in usposabljanj za MSP;
English: MedDRA licence7
Slovenian: Licenca za MedDRA
English: Commission Recommendation 2003/361/EC defines micro, small and medium-sized enterprises.
Slovenian: Mikro, mala in srednje velika podjetja so opredeljena v Priporočilu Komisije 2003/361/ES.
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.
Slovenian: Evropska agencija za zdravila za spodbujanje inovativnosti in razvoja novih zdravil v malih in srednje velikih podjetjih zagotavlja spodbude za tista podjetja, ki razvijajo zdravila za uporabo v humani ali veterinarski medicini
English: • fee incentives (see table)
Slovenian: • spodbude v zvezi s pristojbinami (glejte preglednico);
English: https://ec.europa.eu/programmes/horizon2020/
Slovenian: Cordis http://cordis.europa.eu/ Horizon 2020 https://ec.europa.eu/programmes/horizon2020/
English: For information on SME companies registered with the Agency
Slovenian: Za informacije o MSP, registriranih pri agenciji.
English: • assistance with translations of the product information required for the granting of an EU marketing authorisation
Slovenian: • pomoč pri zagotovitvi prevoda informacij o zdravilu, ki se zahteva pri odobritvi dovoljenja EU za promet z zdravilom;
English: To qualify for SME status, companies must meet the following criteria:
Slovenian: Do statusa MSP so upravičena podjetja, ki izpolnjujejo naslednja pogoja:
English: Scientific services
Slovenian: Znanstvene storitve
English: • guidance on clinical data publication and provision of a free redaction tool license
Slovenian: • usmerjanje pri objavi kliničnih podatkov in zagotovitev brezplačne licence za uporabo orodje za urejanje.
English: 100% fee reduction for products granted eligibility to the Priority Medicines (PRIME) scheme
Slovenian: 100-odstotno znižanje pristojbine za zdravila, ki so upravičena prek sheme prednostnih zdravil (PRIME)
English: • inclusion in the public SME register
Slovenian: • vključitev v javni register MSP;
English: A substantial fee reduction for scientific advice is available to SMEs (see table).
Slovenian: MSP so lahko upravičena do znatnega znižanja pristojbine za znanstveno svetovanje (glejte preglednico).
English: European Small Business Portal
Slovenian: Evropski portal za MSP
English: • be established in the European Economic Area
Slovenian: • imajo sedež v Evropskem gospodarskem prostoru (EGP);
English: Further information on the definition of an SME is available in the ‘User guide to the SME definition'2.
Slovenian: Več informacij o opredelitvi MSP je na voljo v publikaciji „Smernice za opredelitev MSP“
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.
Slovenian: Glede na kategorijo podjetja bo morda treba pri ugotavljanju izpolnjevanja meril za MSP deloma oziroma v celoti upoštevati tudi število zaposlenih in finančne podatke drugih partnerskih ali povezanih podjetij.
English: SMEs are encouraged to seek scientific advice from the Agency early in the development process.
Slovenian: MSP priporočamo, da že na začetku postopka razvoja zdravila agencijo zaprosijo za znanstveno svetovanje.
English: 7For micro- and small-sized enterprises only
Slovenian: Izključno za mikro in mala podjetja.
English: Website www.ema.europa.eu
Slovenian: Spletišče: www.ema.europa.eu
English: E-mail sme@ema.europa.eu
Slovenian: E-pošta: sme@ema.europa.eu
English: 90% fee reduction and deferral 100% fee reduction for designated orphan products
Slovenian: 90-odstotno znižanje pristojbine in odlog plačila 100-odstotno znižanje pristojbine za zdravila sirote
English: • regulatory updates via SME Newsletters and mailings targeted to SMEs
Slovenian: • sporočanje regulativnih sprememb prek glasila MSP in pošte, namenjene MSP;
English: Fee incentives
Slovenian: Spodbude glede pristojbin
English: Inspection (pre-authorisation)
Slovenian: Inšpekcijski pregled (pred izdajo dovoljenja za promet)
English: European Medicines Agency SME Office
Slovenian: European Medicines Agency
English: The SME Office offers assistance to SMEs through dedicated personnel within the Agency.
Slovenian: Posebna skupina zaposlenih urada za MSP znotraj agencije nudi pomoč malim in srednje velikim podjetjem.
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.
Slovenian: 3, ki je objavljen na spletni strani agencije, in ga poslati uradu za MSP skupaj z zadnjimi letnimi računovodskimi izkazi, podatki o lastništvu ter dokazilom o sedežu podjetja v EGP.
English: For information on the whole spectrum of EU policies, legislation, programmes and initiatives relevant to Europe's SMEs:
Slovenian: Za informacije o celotnem spektru politik, zakonov, programov in pobud EU, namenjenim evropskim MSP: http://ec.europa.eu/small-business/index_en.htm
English: 40% fee reduction for small or medium-sized enterprises during the first year after marketing authorisation
Slovenian: 100-odstotno znižanje pristojbine za zdravila sirote v prvem letu po izdaji dovoljenja za promet z zdravilom
English: Establishment of MRLs5
Slovenian: Določitev vrednosti MRL
English: Fee deferral Conditional fee exemption4
Slovenian: Odlog plačila Pogojna oprostitev od plačila pristojbine
English: The incentives offered by the SME Regulation apply to the human and veterinary sectors, and include:
Slovenian: Spodbude, ki jih ureja uredba o MSP, so namenjene sektorjema proizvodnje zdravil za uporabo v humani medicini in veterinarski medicini.
English: To maintain its SME status, the company should submit a completed declaration annually, based on its latest approved accounts.
Slovenian: Prosilec bo prejel številko EMA-MSP, ko bo status MSP odobren.Podjetje mora na podlagi zadnjih revidiranih računovodskih izkazov vsako leto znova predložiti izpolnjeno izjavo, da obdrži status MSP.
English: Horizon 2020
Slovenian: marec 2017
English: Administrative services6
Slovenian: Upravne storitve
English: Application for marketing authorisation
Slovenian: Vloga za izdajo dovoljenja za promet z zdravilom
English: Inspection (post-authorisation)
Slovenian: Inšpekcijski pregled (po izdaji dovoljenja za promet z zdravilom)
English: 4In the event of a negative outcome, where EMA scientific advice has been sought and followed 5Maximum Residue Limits
Slovenian: V primeru negativnega izida, če podjetje zaprosi za znanstveno mnenje agencije in ga upošteva.
English: Fee exemption for micro-sized enterprises
Slovenian: Izjeme glede pristojbin za mikro podjetja 40-odstotno znižanje pristojbine za mala in srednje velika podjetja
English: 1According to Commission Regulation (EC) No 2049/2005 2See European Commission/Growth/Publications 3See SME Office area at www.ema.europa.eu
Slovenian: V skladu z Uredbo Komisije (ES) št. 2049/2005.
English: SME support
Slovenian: Podpora MSP
English: 90% fee reduction for non-orphan products
Slovenian: Spodbuda v zvezi s pristojbinami 100-odstotno znižanje pristojbine za zdravila sirote
English: Activity/application Fee incentives
Slovenian: Spodbuda v zvezi s pristojbinami
English: 8See fees area at www.ema.europa.eu
Slovenian: Glejte razdelek urada za MSP na spletišču ema.europa.eu.
English: The applicant will receive an EMA-SME number once the SME status has been assigned.
Slovenian: Kako zaprositi za status MSP?
English: Take only one tablet per day.
Slovenian: Vzemite samo eno tableto na dan.
English: See also section 2, “Warnings and precautions”.
Slovenian: Glejte tudi poglavje 2, »Opozorila in previdnostni ukrepi«.
English: Study 101
Slovenian: Študija 101
English: Thereafter, monitoring should be performed periodically.
Slovenian: Nato je treba redno izvajati spremljanje.
English: See also the beginning of section 4.
Slovenian: Glejte tudi začetek poglavja 4.
English: CI‡
Slovenian: IZ‡
English: • sensitivity to sunlight
Slovenian: • občutljivost na sončno svetlobo
English: Version 4.0 (NCI CTCAE v4).
Slovenian: Različica 4.0 (NCI CTCAE v4).
English: 12-month survival probability (%)
Slovenian: Verjetnost preživetja 12 mesecev (%)
English: The recommended dose is
Slovenian: Priporočen odmerek je
English: Treatment should continue as long as clinical benefit is observed.
Slovenian: Zdravljenje se mora nadaljevati, dokler je opazna klinična korist.
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.
Slovenian: Vaš zdravnik lahko prilagodi vaš odmerek glede na vaše potrebe in to lahko zahteva uporabo 30 mg tablete za doseganje novega priporočenega odmerka.
English: Take your next dose at your regular time.
Slovenian: Naslednji odmerek vzemite obrednem času.
English: There are no available data on patients over 85 years of age.
Slovenian: Podatki za bolnike, starejše od 85 let, niso na voljo.
English: Available data cannot exclude potential excretion in human milk.
Slovenian: Razpoložljivi podatki ne morejo izključiti morebitnega izločanja v materino mleko.
English: 95% CI
Slovenian: 95% IZ
English: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Slovenian: Prekinitev in/ali zmanjšanje odmerka bosta morda potrebna na podlagi individualne ocene varnosti in prenašanja.
English: The median duration of follow-up was 22.9 months.
Slovenian: Povprečno trajanje sledenja zdravljenja je bilo 22,9 meseca.
English: Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Kategorije pogostnosti so zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10) in občasni (≥1/1.000 do <1/100).
English: • Take Alunbrig once daily at the same time each day.
Slovenian: • Vzemite zdravilo Alunbrig enkrat na dan, vsak dan ob istem času.
English: Symptoms may be similar to symptoms from lung cancer.
Slovenian: Znaki so lahko podobni znakom pljučnega raka.
English: IRC assessment
Slovenian: Ocena IRC
English: Transporter substrates
Slovenian: Transportni substrati
English: It is unknown if brigatinib passes into breast milk and could potentially harm the baby.
Slovenian: Ni znano, če brigatinib prehaja v materino mleko in bi lahko potencialno škodoval otroku.
English: Investigator assessment
Slovenian: Ocena preiskovalca
English: The blood-to-plasma concentration ratio is 0.69.
Slovenian: Razmerje koncentracije v plazmi in krvi je 0,69.
English: Time to response
Slovenian: Čas za odziv
English: Age, body weight, and albumin concentrations
Slovenian: Starost, telesna masa in koncentracije albumina
English: A patient alert card
Slovenian: Opozorilna kartica za bolnika
English: Tell your doctor or pharmacist right away if you have taken more tablets than recommended.
Slovenian: Takoj obvestite svojega zdravnika ali farmacevta, če ste vzeli več tablet kot je priporočeno.
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.
Slovenian: Poleg tega so bili vključeni bolniki z metastazami centralnega živčnega sistema (CNS), če so bili nevrološko stabilni in niso potrebovali povečanega odmerka kortikosteroidov.
English: The tablets should be swallowed whole and with water.
Slovenian: Tablete je treba pogoltniti cele in z vodo.
English: Hypertension should be treated according to standard guidelines to control blood pressure.
Slovenian: Hipertenzijo je treba zdraviti v skladu s standardnimi smernicami za nadzor krvnega tlaka.
English: See the package leaflet for further information.
Slovenian: Glejte priložena navodila za več informacij.
English: • increased blood clotting time shown by test of activated partial thromboplastin time
Slovenian: • podaljšan čas strjevanja krvi opažen pri preiskavah aktiviranega delnega tromboplastinskega časa
English: • Swallow the tablets whole, with a glass of water.
Slovenian: • Tablete pogoltnite cele s kozarcem vode.
English: Alunbrig blocks the action of this protein and thus slows down the growth and spread of the cancer.
Slovenian: Alunbrig blokira delovanje tega proteina in tako upočasni rast in širjenje raka.
English: The following medicines can affect or be affected by Alunbrig:
Slovenian: Naslednja zdravila lahko vplivajo na ali nanje vpliva zdravilo Alunbrig:
English: • The tablets can be taken with or without food.
Slovenian: • Tablete lahko jemljete s hrano ali brez nje.
English: Within each frequency grouping, undesirable effects are presented in order of frequency.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki razvrščeni glede na pogostnost pojavljanja.
English: • difficulty sleeping (insomnia)
Slovenian: • težave s spancem (nespečnost)
English: Table 4: Efficacy results in ALTA (ITT population) Efficacy parameter
Slovenian: Preglednica 4: Rezultati učinkovitosti v ALTA (populacija ITT) Parameter učinkovitosti
English: The major outcome measure was confirmed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) as evaluated by investigator.
Slovenian: Glavni dejavnik izida je bila potrjena objektivna stopnja odziva (ORR-objective response rate) v skladu s kriteriji ocenjevanja odziva pri solidnih tumorjih (RECIST v1.1), kot jih je ocenil raziskovalec.
English: Testicular toxicity was observed in repeat-dose animal studies.
Slovenian: Toksičnost je bila opažena pri študijah ponavljajočih se odmerkov na živalih.
English: (3.7, NE)
Slovenian: (3,7; NO)
English: Avoid any grapefruit products during treatment as they may change the amount of brigatinib in your body.
Slovenian: Med zdravljenjem se izogibajte izdelkom iz grenivk, ker lahko spremenijo količino brigatiniba v telesu.
English: Modest accumulation was observed upon repeated dosing (geometric mean accumulation ratio: 1.9 to 2.4).
Slovenian: Manjše kopičenje je bilo opaženo pri ponavljajočem odmerjanju (geometrično povprečno razmerje kopičenja: 1,9 do 2,4).
English: The clinical relevance of these findings to human fertility is unknown.
Slovenian: Klinični pomen teh ugotovitev na plodnost pri ljudeh ni znan.
English: Grade 3 hyperglycemia occurred in 7.3% of patients.
Slovenian: Hiperglikemija stopnja 3 se je pojavila pri 7,3% bolnikov.
English: 90 mg once daily (first 7 days)
Slovenian: 90 mg enkrat na dan (prvih 7 dni)
English: Most pulmonary adverse reactions were observed within the first 7 days of treatment.
Slovenian: Večina neželenih učinkov na pljuča je bila opažena v prvih 7 dneh zdravljenja.
English: Brigatinib was moderately bound (91%) to human plasma proteins and binding was not concentration-dependent.
Slovenian: Brigatinib je bil zmerno vezan (91%) na proteine humane plazme in vezava ni odvisna od koncentracije.
English: Carcinogenicity studies have not been performed with brigatinib.
Slovenian: Študije kancerogenosti z brigatinibom niso bile izvedene.
English: Women of childbearing potential/Contraception in males and females
Slovenian: Ženske v rodni dobi/Kontracepcija za moške in ženske
English: Antihyperglycaemic treatment should be initiated or optimised as needed.
Slovenian: Po potrebi je treba začeti ali optimizirati antihiperglikemično zdravljenje.
English: Randomisation was stratified by brain metastases (present, absent) and best prior response to crizotinib therapy (complete or partial response, any other response/unknown).
Slovenian: Randomizacija je bila stratificirana z metastazami v možganih (prisotno, odsotno) in najboljšim predhodnim odzivom na terapijo s krizotinibom (popolni ali delni odziv, kateri koli drugi odziv/neznano).
English: Heart rate and blood pressure should be monitored regularly.
Slovenian: Redno je treba spremljati srčni utrip in krvni tlak.
English: Liver function, including AST, ALT and total bilirubin should be assessed prior to the initiation of Alunbrig and then every 2 weeks during the first 3 months of treatment.
Slovenian: Delovanje jeter, vključno z AST, ALT in celotnim bilirubinom, je treba oceniti pred začetkom zdravljenja z zdravilom Alunbrig in nato vsaka 2 tedna v prvih 3 mesecih zdravljenja.
English: Additional outcome measures included confirmed ORR as evaluated by an Independent Review Committee (IRC); time to response; progression free survival (PFS); duration of response (DOR); overall survival; and intracranial ORR and intracranial DOR as evaluated by an IRC.
Slovenian: Dodatni ukrepi so vključevali potrjen ORR, ki ga je ocenil neodvisni revizijski odbor (IRC- Independent Review Committee); čas za odziv; preživetje brez napredovanja bolezni (PFSprogression free survival); trajanje odziva (DOR- duration of response); celokupno preživetje; in intrakranialni ORR in intrakranialni DOR, kot jih oceni IRC.
English: • inflammation of pancreas which may cause severe and persistent stomach pain, with or without nausea and vomiting (pancreatitis)
Slovenian: • vnetje trebušne slinavke, ki lahko povzroči hude in trajne bolečine v želodcu, z ali brez siljenja na bruhanje bruhanja (pankreatitis)
English: Objective response rate
Slovenian: Objektivna stopnja odziva
English: Bradycardia with life-threatening consequences, urgent intervention indicated
Slovenian: Bradikardija z življenjsko ogrožajočimi posledicami, potrebno je bilo nujno posredovanje
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.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, da se pogovorite o tveganjih povezanih z jemanjem zdravila Alunbrig med nosečnostjo.