FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Vantobra, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Danish: Det aktive stof i Vantobra, tobramycin, tilhører lægemiddelgruppen aminoglykosider.
English: Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule into a fine mist.
Danish: Vantobra inhaleres med Tolero-nebulisatoren, der omdanner opløsningen i ampullerne til en fin tåge.
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.
Danish: Tobramycin har i en del år været anvendt til behandling af infektioner med P. aeruginosa hos patienter med cystisk fibrose, og ansøgeren forelagde litteraturdata som dokumentation for anvendelsen af
English: The results of the study showed that Vantobra can be considered
Danish: Undersøgelsen viste, at Vantobra kan anses for at svare til Tobi.
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
Danish: CHMP bemærkede, at tobramycin i form af inhalationsvæske var “guldstandard” for behandling af infektioner med P. aeruginosa hos patienter med cystisk fibrose, og at nogle patienter ikke tåler det tørre pulver.
English: What benefits of Vantobra have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vantobra?
English: For practical information about using Vantobra, patients should read the package leaflet or contact
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vantobra, kan du læse indlægssedlen eller
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.
Danish: Cystisk fibrose er en arvelig sygdom, der medfører ophobning af slim i lungerne.
English: Vantobra is available as a nebuliser solution in single-dose containers called ‘ampoules'.
Danish: Vantobra fås som inhalationsvæske til nebulisator i enkeltdosisbeholdere (ampuller).
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Vantobra
English: Other incentives include:
Danish: Andre incitamenter omfatter:
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.
Danish: • beskæftige færre end 250 medarbejdere og have en årlig omsætning på ikke over 50 mio. EUR eller en årlig samlet balance på ikke over 43 mio. EUR.
English: For information on administrative and procedural aspects of the pharmaceutical legislation
Danish: Information om de administrative og proceduremæssige aspekter af lægemiddellovgivningen.
English: To qualify for SME status, companies must meet the following criteria:
Danish: For at blive kvalificeret som SMV skal virksomhederne opfylde følgende kriterier:
English: The incentives offered by the SME Regulation apply to the human and veterinary sectors, and include:
Danish: Incitamenterne i SMV-forordningen gælder både på det human- og veterinærmedicinske område og omfatter:
English: The applicant will receive an EMA-SME number once the SME status has been assigned.
Danish: Ansøgeren vil modtage et SMV-nummer fra EMA, når SMV-statussen er blevet tildelt.
English: • assistance with translations of the product information required for the granting of an EU marketing authorisation
Danish: • bistand med oversættelse af den produktinformation, der kræves i forbindelse med udstedelse af en EU-markedsføringstilladelse
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.
Danish: For at fremme SMV'ernes innovation og udvikling af nye lægemidler tilbyder Det Europæiske Lægemiddelagentur incitamenter til de SMV'er, der udvikler humanmedicinske lægemidler og veterinærlægemidler
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.
Danish: SMV'er kan få direkte hjælp med den lovmæssige del af registreringen, herunder briefing-møder for SMV'er, der sigter mod at lette interaktionen med agenturet og yde vejledning vedrørende rammerne for EU-registrering og de redskaber, der kan støtte innovation.
English: Telephone +44 (0)20 3660 8787 Fax +44 (0)20 3660 5555
Danish: Fax +44 (0)20 3660 5555
English: Further information on the definition of an SME is available in the ‘User guide to the SME definition'2.
Danish: Yderligere oplysninger om definitionen af SMV er tilgængelig i "Brugervejledning til definitionen af SMV'er"
English: Useful sources of information
Danish: Nyttige informationskilder
English: SMEs are encouraged to seek scientific advice from the Agency early in the development process.
Danish: SMV'er opfordres til allerede tidligt i udviklingsprocessen at søge videnskabelig rådgivning hos agenturet.
English: Addressing the needs of small and medium-sized enterprises (SMEs) and promoting innovation
Danish: SMV-kontoret - Håndtering af behovene i mikrovirksomheder samt små og mellemstore virksomheder (SMV'er) og fremme af innovation
English: • inclusion in the public SME register
Danish: • medtagelse i det offentlige SMV-register
English: A substantial fee reduction for scientific advice is available to SMEs (see table).
Danish: SMV'er kan opnå en betragtelig gebyrnedsættelse for videnskabelig rådgivning (se tabel).
English: This helps the sponsor to ensure that the appropriate studies are performed and maximises the chances of a successful marketing authorisation.
Danish: Dermed kan den enkelte virksomhed sikre sig, at de nødvendige undersøgelser gennemføres, og at chancen for udstedelse af en markedsføringstilladelse bliver størst mulig.
English: https://ec.europa.eu/programmes/horizon2020/
Danish: http://cordis.europa.eu/ Horisont 2020 https://ec.europa.eu/programmes/horizon2020/
English: • guidance on clinical data publication and provision of a free redaction tool license
Danish: • vejledning vedrørende publicering af kliniske data og mulighed for at bruge en gratis licens til et redigeringsværktøj
English: 6Excluding parallel distribution
Danish: paralleldistribution
English: Application for marketing authorisation
Danish: Ansøgning om markedsføringstilladelse
English: • organisation of info days and training sessions for SMEs
Danish: • organisering af informationsdage og kurser for SMV'er
English: To maintain its SME status, the company should submit a completed declaration annually, based on its latest approved accounts.
Danish: For at bevare statussen som SMV skal virksomheden hvert år indsende en ny erklæring med tallene fra det seneste godkendte regnskab.
English: MedDRA licence7
Danish: MedDRA-licens
English: 1According to Commission Regulation (EC) No 2049/2005 2See European Commission/Growth/Publications 3See SME Office area at www.ema.europa.eu
Danish: I henhold til Kommissionens forordning (EF) nr. 2049/2005 Se European Commission/Growth/Publications Se SMV-kontor-sektionen på ema.europa.eu.
English: Post-authorisation procedures, including pharmacovigilance activities
Danish: Procedurer efter godkendelse, herunder bivirkningsovervågning
English: • be established in the European Economic Area
Danish: • være hjemmehørende i Det Europæiske Økonomiske Samarbejdsområde (EØS)
English: Establishment of MRLs5
Danish: Fastsættelse af MRL'er
English: For information on SME companies registered with the Agency
Danish: Oplysninger om SMV-virksomheder, der er registreret hos agenturet.
English: • fee incentives (see table)
Danish: • gebyrincitamenter (se tabel)
English: Website www.ema.europa.eu
Danish: Websted www.ema.europa.eu
English: Details on fees and fee reductions are available in the explanatory note on general fees payable to the European Medicines Agency8.
Danish: Oplysninger om gebyrer og gebyrnedsættelser findes i en forklarende note om generelle gebyrer, der skal betales til EMA
English: 4In the event of a negative outcome, where EMA scientific advice has been sought and followed 5Maximum Residue Limits
Danish: I tilfælde af et negativt resultat, hvor der er søgt om videnskabelig rådgivning hos EMA, og rådgivningen er blevet fulgt.
English: Commission Recommendation 2003/361/EC defines micro, small and medium-sized enterprises.
Danish: Mikrovirksomheder og små og mellemstore virksomheder er defineret i Kommissionens henstilling 2003/361/EF.
English: European Small Business Portal
Danish: Portal for europæiske SMV'er
English: Inspection (post-authorisation)
Danish: Inspektion (efter godkendelse)
English: Scientific services
Danish: Videnskabelige tjenester
English: 7For micro- and small-sized enterprises only
Danish: Kun for mikrovirksomheder og små virksomheder
English: Inspection (pre-authorisation)
Danish: Inspektion (før godkendelse)
English: EMA user guide for SMEs3
Danish: EMA's brugervejledning til SMV'er
English: Research funding
Danish: Forskningsstøtte
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.
Danish: Alt efter hvilken kategori virksomheden tilhører, kan det ved beregningen af, om SMV-kriterierne er opfyldt, være nødvendigt helt eller delvist at medregne antallet af ansatte hos eller finansielle data for andre partnervirksomheder eller tilknyttede virksomheder.
English: • regulatory updates via SME Newsletters and mailings targeted to SMEs
Danish: • nyheder om registrering gennem SMV-nyhedsbreve og forsendelser rettet mod SMV'er
English: 40% fee reduction for small or medium-sized enterprises during the first year after marketing authorisation
Danish: Gebyrfritagelse for mikrovirksomheder 40 %-nedsættelse af gebyret for små og mellemstore virksomheder 100 %-nedsættelse af gebyret for udpegede lægemidler til sjældne sygdomme i løbet af det første år efter markedsføringstilladelse
English: European Medicines Agency SME Office
Danish: Det Europæiske Lægemiddelagentur
English: For information on the whole spectrum of EU policies, legislation, programmes and initiatives relevant to Europe's SMEs:
Danish: Information om hele spektret af EU-politikker, lovgivning, programmer og initiativer, som er relevante for de europæiske SMV'er: http://ec.europa.eu/small-business/index_en.htm
English: The SME Office offers assistance to SMEs through dedicated personnel within the Agency.
Danish: SMV-kontoret har en særlig gruppe af medarbejdere, der yder bistand til SMV'er.
English: SME definition
Danish: findes på
English: Activity/application Fee incentives
Danish: Aktivitet/ansøgning
English: Horizon 2020
Danish: marts 2017
English: 90% fee reduction and deferral 100% fee reduction for designated orphan products
Danish: 90 %-nedsættelse af gebyret og udskydelse 100 %-nedsættelse af gebyret for udpegede lægemidler til sjældne sygdomme
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.
Danish: Det skal udfyldes og sendes til SMV-kontoret sammen med de seneste afsluttede årsregnskaber, ejerskabsoplysninger og dokumentation for, at virksomheden har hjemsted i EØS.
English: Administrative services6
Danish: Administrative tjenester
English: 100% fee reduction for products granted eligibility to the Priority Medicines (PRIME) scheme
Danish: 90 %-nedsættelse af gebyret for lægemidler til ikke-sjældne sygdomme 100 %-nedsættelse af gebyret for udpegede lægemidler til sjældne sygdomme 100 %-nedsættelse af gebyret for produkter, der er godkendt i ordningen vedrørende prioriterede lægemidler (PRIME)
English: SME support
Danish: SMV-støtte
English: For information on EU funding: Cordis http://cordis.europa.eu/
Danish: Information om forskningsstøtte: Cordis
English: Fee incentives
Danish: Gebyrudskydelse
English: 90% fee reduction for non-orphan products
Danish: 90 %-nedsættelse af gebyret for lægemidler til ikke-sjældne sygdomme 100 %-nedsættelse af gebyret for udpegede lægemidler til sjældne sygdomme
English: Regulatory assistance
Danish: Hjælp i forbindelse med registrering
English: Fee exemption for micro-sized enterprises
Danish: Støtte til SMV'er
English: Take only one tablet per day.
Danish: Tag kun én tablet om dagen.
English: Abbreviations: ITT = Intent-to-treat
Danish: Forkortelser: ITT = Intent-to-treat
English: See also section 2, “Warnings and precautions”.
Danish: Se også punkt 2, “Advarsler og forsigtighedsregler”.
English: Date of first authorisation: 22 November 2018
Danish: Dato for første markedsføringstilladelse: 22 november 2018
English: See also the beginning of section 4.
Danish: Se også begyndelsen af afsnit 4.
English: Study 101
Danish: Studie 101
English: • Take Alunbrig once daily at the same time each day.
Danish: • Tag Alunbrig en gang daglig på samme tidspunkt hver dag.
English: There are no available data on patients over 85 years of age.
Danish: Der foreligger ingen data om patienter over 85 år.
English: 12-month survival probability (%)
Danish: 12-måneders sandsynlighed for overlevelse (%)
English: Day 8 to Day 28
Danish: Dag 8 til dag 28
English: The blood-to-plasma concentration ratio is 0.69.
Danish: Blod-til-plasma-koncentrationsforholdet er 0,69.
English: Available data cannot exclude potential excretion in human milk.
Danish: Tilgængelige data kan ikke udelukke potentiel udskillelse i human mælk.
English: The median duration of follow-up was 22.9 months.
Danish: Den mediane varighed af opfølgning var 22,9 måneder.
English: • difficulty sleeping (insomnia)
Danish: • svært ved at sove (søvnløshed)
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.
Danish: Din læge kan tilpasse din dosis efter dine behov, og dette kan betyde, at du skal tage en 30 mg tablet for at opnå en ny lægeanbefalet dosis.
English: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Danish: Det kan være nødvendigt at afbryde og/eller reducere dosis på baggrund af sikkerhed og tolerabilitet hos den enkelte patient.
English: Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppighedskategorierne er meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: Treatment should continue as long as clinical benefit is observed.
Danish: Behandling bør videreføres, så længe der er kliniske fordele.
English: • sensitivity to sunlight
Danish: • følsomhed over for sollys
English: Day 1 to Day 7
Danish: Dag 1 til dag 7
English: Symptoms may be similar to symptoms from lung cancer.
Danish: Symptomerne kan ligne de symptomer, der skyldes lungekræft.
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.
Danish: Desuden blev patienter med metastaser til centralnervesystemet (CNS) medtaget, hvis de var neurologisk stabile og ikke krævede en stigende dosis kortikosteroider.
English: The following medicines can affect or be affected by Alunbrig:
Danish: Disse lægemidler kan påvirke eller påvirkes af Alunbrig:
English: • The tablets can be taken with or without food.
Danish: • Tabletterne kan tages med eller uden mad.
English: Most pulmonary adverse reactions were observed within the first 7 days of treatment.
Danish: De fleste pulmonale bivirkninger blev observeret inden for de første 7 dages behandling.
English: Thereafter, monitoring should be performed periodically.
Danish: Derefter skal testning gennemføres regelmæssigt.
English: Do not change the dose without talking to your doctor.
Danish: Undlad at ændre dosis uden at tale med lægen.
English: Note: Progression-Free survival was defined as time from initiation of treatment until the date at which disease progression was first evident or death, whichever comes first.
Danish: Bemærk: Progressionsfri overlevelse blev defineret som tiden fra indledning af behandlingen indtil den dato, hvor sygdomsprogression første gang blev tydelig, eller dødsfald (første værdi gælder).
English: • Swallow the tablets whole, with a glass of water.
Danish: • Synk tabletterne hele sammen med et glas vand.
English: Macrogol Polyvinyl alcohol Titanium dioxide
Danish: Macrogol Polyvinylalkohol Titandioxid
English: Brigatinib can be administered with or without food.
Danish: Brigatinib kan administreres med eller uden mad.
English: Age, body weight, and albumin concentrations
Danish: Alder, legemsvægt og albuminkoncentrationer
English: The clinical relevance of these findings to human fertility is unknown.
Danish: Den kliniske relevans af disse fund for human fertilitet er ukendt.
English: IRC assessment
Danish: IRC-bedømmelse
English: Alunbrig with food and drink
Danish: Brug af Alunbrig sammen med mad og drikke
English: Avoid any grapefruit products during treatment as they may change the amount of brigatinib in your body.
Danish: Undgå grapefrugt og produkter indeholdende grapefrugt under behandlingen, da de kan ændre mængden af brigatinib i din krop.
English: Antihyperglycaemic treatment should be initiated or optimised as needed.
Danish: Antihyperglykæmisk behandling skal opstartes eller optimeres efter behov.
English: Women of childbearing potential/Contraception in males and females
Danish: Kvinder i fødedygtig alder/kontraception hos mænd og kvinder
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.
Danish: Disse virkninger var generelt reversible under restitutionsperioden uden dosering, men virkninger i øjne og testes var betydningsfulde undtagelser som følge af manglende restitution.
English: Brigatinib was moderately bound (91%) to human plasma proteins and binding was not concentration-dependent.
Danish: Brigatinib var moderat bundet (91 %) til humane plasmaproteiner, og bindingen var ikke koncentrations-afhængig.
English: Do not use this medicine after the expiry date which is stated on either the bottle label or blister and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på enten etiketten på beholderen eller på blisterkortet og på pakningen efter ”EXP”.
English: Bradycardia (HR less than 60 bpm)
Danish: Bradykardi (HF under 60 bpm)
English: Alunbrig is for oral use.
Danish: Alunbrig er til oral anvendelse.
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.
Danish: Det primære effektmålt var bekræftet objektiv responsrate (ORR) i henhold til Response Evaluation Criteria in Solid Tumors (RECIST v1.1) som bedømt af investigator.
English: Talk to your doctor before taking Alunbrig or during treatment if you have:
Danish: Kontakt lægen, før du tager Alunbrig samt under behandlingen, hvis du har:
English: Investigations Common Weight decreased Uncommon
Danish: Undersøgelser Almindelig Vægttab Ikke almindelig
English: It is unknown whether Alunbrig is excreted in human milk.
Danish: Det er ukendt, om Alunbrig udskilles i human mælk.
English: Do not drive or use machines during treatment if such signs occur.
Danish: Undlad at føre motorkøretøj eller bruge maskiner under behandlingen, hvis du oplever disse symptomer.
English: Randomisation was stratified by brain metastases (present, absent) and best prior response to crizotinib therapy (complete or partial response, any other response/unknown).
Danish: Randomiseringen blev opdelt efter hjernemetastaser (til stede, fraværende) og bedste tidligere respons på crizotinib-behandling (komplet eller delvist respons, ethvert andet respons/ukendt).
English: Alunbrig has minor influence on the ability to drive and use machines.
Danish: Alunbrig påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: These factors should be considered when initiating treatment with Alunbrig.
Danish: Disse faktorer skal tages med i betragtning ved indledning af behandling med Alunbrig.
English: • pain in arms and legs
Danish: • smerter i arme og ben
English: Adverse reactions reported in ALTA and Study 101 at the recommended dosing regimen are presented in Table 3 and are listed by system organ class, preferred term and frequency.
Danish: Bivirkninger rapporteret i ALTA og Studie 101 ved det anbefalede doseringsregime er vist i tabel 3 og er anført efter systemorganklasse, foretrukken term og hyppighed.
English: Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med Alunbrig skal indledes og overvåges af en læge med erfaring i brug af lægemidler til behandling af cancer.
English: 90 mg once daily (first 7 days)
Danish: 90 mg en gang daglig (de første 7 dage)
English: There are no clinical data on the use of Alunbrig in pregnant women.
Danish: Der er ingen kliniske data fra anvendelse af Alunbrig til gravide kvinder.
English: Tell your doctor or pharmacist right away if you have taken more tablets than recommended.
Danish: Fortæl det til lægen eller apotekspersonalet med det samme, hvis du har taget flere tabletter end anbefalet.
English: Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Danish: Vurderingen af ALK-positiv NSCLC skal udføres af laboratorier med dokumenterede kompetencer i brugen af den specifikke teknologi, der bliver anvendt.
English: • inflammation of pancreas which may cause severe and persistent stomach pain, with or without nausea and vomiting (pancreatitis)
Danish: • betændelse i bugspytkirtlen, som kan medføre alvorlige og vedvarende mavesmerter, med eller uden kvalme og opkastning (pankreatit)
English: Alunbrig blocks the action of this protein and thus slows down the growth and spread of the cancer.
Danish: Alunbrig blokerer virkningen af dette protein, hvilket forsinker vækst og spredning af kræften.
English: The limited data on the safety and efficacy of Alunbrig in patients aged 65 years and older suggest that a dose adjustment is not required in elderly patients (see section 4.8).
Danish: De begrænsede data vedrørende sikkerhed og virkning af Alunbrig hos patienter i alderen 65 år og ældre tyder på, at dosisjustering ikke er nødvendig hos ældre patienter (se pkt.
English: Your doctor may need to adjust your treatment or stop Alunbrig temporarily or permanently.
Danish: Det kan være nødvendigt for lægen at ændre behandlingen eller afbryde behandling med Alunbrig midlertidigt eller permanent.
English: Visual Disturbance Grade 2 or 3
Danish: Synsforstyrrelser Grad 2 eller 3
English: In ALTA, 13.5% of patients ≥ 65 years of age experienced an early pulmonary adverse reaction compared with 4.2% of patients < 65 years of age.
Danish: I ALTA fik 13,5 % af patienterne ≥ 65 år en tidlig pulmonal bivirkning sammenlignet med 4,2 % af patienter < 65 år.
English: There is no specific antidote for overdose with Alunbrig.
Danish: Der er ingen specifikt antidot mod en overdosis af Alunbrig.
English: Hypertension should be treated according to standard guidelines to control blood pressure.
Danish: Hypertension skal behandles i henhold til rekommandationer og retningslinjer for kontrol af blodtryk.
English: Median (months)
Danish: Samlet overlevelse Median (måneder)