FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Alimta, used on its own or with other anticancer medicines, are bone marrow suppression (when the bone marrow produces less blood cells than normal) and gastrointestinal toxicities (side effects affecting the stomach and gut).
Danish: De hyppigste bivirkninger ved Alimta, givet alene eller sammen med andre lægemidler mod kræft, er nedsat knoglemarvsfunktion (hvor knoglemarven danner færre blodlegemer end normalt) og gastrointestinal toksicitet (bivirkninger, der påvirker mave og tarme).
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Alimta.
Danish: For at mindske bivirkningerne bør patienten under behandlingen med Alimta tage et kortikosteroid (et lægemiddel, som reducerer inflammationen) og folinsyre (et vitamin) og få indsprøjtninger med vitamin B12.
English: Bone marrow suppression causes decreased levels in the blood of white blood cells (the cells that fight infection), platelets (components that help the blood to clot) and haemoglobin (the protein found in red blood cells that carries oxygen around the body).
Danish: Nedsat knoglemarvsfunktion medfører et for lavt antal hvide blodlegemer (som bekæmper infektion), blodplader (som hjælper blodet med at størkne) og hæmoglobin (det protein i røde blodlegemer, der transporterer ilt rundt i kroppen).
English: How has Alimta been studied?
Danish: Hvordan blev Alimta undersøgt?
English: • advanced ‘non small cell' lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received anticancer treatment.
Danish: • fremskreden ”ikke-småcellet” lungekræft, der ikke er af ”pladecelletypen”, hvor det gives enten i kombination med cisplatin for at behandle patienter, der ikke tidligere er blevet behandlet, eller alene til behandling af patienter, som tidligere har fået kræfthæmmende behandling.
English: What is Alimta used for?
Danish: Hvad anvendes Alimta til?
English: Alimta was also compared with docetaxel (another anticancer medicine) in one study involving 571 patients who had received chemotherapy in the past.
Danish: Alimta blev også sammenlignet med docetaxel (et andet kræftmiddel) i én undersøgelse af 571 patienter, som tidligere havde fået kemoterapi.
English: For maintenance treatment, Alimta was compared with placebo (a dummy treatment) in two main studies involving 1,202 patients whose cancer had not got worse during platinum-based chemotherapy.
Danish: Med hensyn til vedligeholdelsesbehandling blev Alimta sammenlignet med placebo (en virkningsløs behandling) i to hovedundersøgelser af 1 202 patienter, hvis kræftsygdom ikke var blevet forværret under behandling med platinbaseret kemoterapi.
English: What benefit has Alimta shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Alimta?
English: For the treatment of malignant pleural mesothelioma, Alimta in combination with cisplatin has been compared with cisplatin alone in one main study in 456 patients who had not received chemotherapy for their disease before.
Danish: Alimta i kombination med cisplatin blev sammenlignet med cisplatin anvendt alene til behandling af malignt pleura mesotheliom i én hovedundersøgelse af 456 patienter, der ikke tidligere havde fået kemoterapi mod sygdommen.
English: What is Alimta?
Danish: Hvad er Alimta
English: When Alimta is given with cisplatin, an ‘anti emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Danish: Når Alimta gives sammen med cisplatin, bør der desuden før og efter cisplatindosen gives et lægemiddel mod kvalme og opkastninger samt væsketilskud for at forhindre dehydrering.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Danish: I kræftceller sker omdannelsen af pemetrexed til den aktive form hurtigere end i normale celler.
English: How is Alimta used?
Danish: Hvordan anvendes Alimta?
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Danish: Hvis patienten får unormale blodtal, eller der opstår visse andre bivirkninger, bør behandlingen udsættes eller standses, eller dosen nedsættes.
English: For the treatment of locally advanced or metastatic non small cell lung cancer, Alimta was compared with gemcitabine (another anticancer medicine), in combination with cisplatin, in a study involving 1,725 patients who had not received chemotherapy before.
Danish: Alimta blev sammenlignet med gemcitabin (et andet lægemiddel mod kræft), i kombination med cisplatin, til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft i en undersøgelse af 1 725 patienter, som ikke tidligere havde fået kemoterapi.
English: In the treatment of non small cell lung cancer, Alimta was as effective as the comparators, with survival times around 10.3 months in patients who had not received chemotherapy in the past, and around 8.1 months in those who had received chemotherapy in the past.
Danish: Hos patienter, der ikke tidligere havde fået kemoterapi, var den gennemsnitlige overlevelsestid 10,3 måneder, og 8,1 måned for patienter, der havde fået kemoterapi tidligere.
English: Alimta affects fertility, so both men and women who receive it need to be made aware of this.
Danish: Alimta påvirker fertiliteten.
English: 11 February 2015
Danish: Den 11. februar 2015
English: The final opinion was converted into a Decision by the European Commission on 11 February 2015.
Danish: Den endelige udtalelse blev den 11. februar 2015 omarbejdet til en beslutning af EuropaKommissionen.
English: International non-proprietary name (INN): gentamicin
Danish: Internationalt fællesnavn (INN): gentamicin
English: It is normally used as the sulphate salt.
Danish: Normalt anvendes det i form af sulfatsaltet.
English: Written explanations were provided by the applicants and marketing authorisation holders on 16 May 2014 and 4 September 2014.
Danish: Ansøgerne og indehaverne af markedsføringstilladelserne afgav skriftlige redegørelser den 16. maj 2014 og den 4. september 2014.
English: The referral started on 12 March 2014.
Danish: Indbringelsesproceduren blev indledt den 12. marts 2014.
English: The Committee appointed K. Baptiste as rapporteur and C. Muñoz Madero as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis K. Baptiste og C. Muñoz Madero.
English: It is currently included in the list of essential medicines for human use of the World Health Organisation (WHO).
Danish: Der er optaget på Verdenssundhedsorganisationen (WHO's) liste over essentielle lægemidler til mennesker.
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.
Danish: Efter vurdering af de foreliggende data fandt CVMP, at det overordnede benefit/risk-forhold fortsat er positivt for disse produkter, forudsat at der ændres i produktinformationen.
English: In veterinary medicine gentamicin is used mainly as a solution for injection for pigs, cattle and horses and as an oral solution for poultry.
Danish: I veterinærmedicinen anvendes gentamicin hovedsagelig som injektionsvæske til svin, kvæg og heste og som oral opløsning til fjerkræ.
English: It is also used in human medicine, usually as a solution for injection for intramuscular administration.
Danish: Det anvendes desuden i humanmedicinen, sædvanligvis som injektionsvæske til intramuskulær indgift.
English: The CVMP was requested to harmonise the indications and dosing regimens of the concerned products, taking into account the available data and in particular with regard to the target animal safety.
Danish: CVMP blev anmodet om at harmonisere indikationer og doseringsregimer for de pågældende lægemidler på grundlag af de foreliggende data, navnlig under hensyn til sikkerheden for måldyrearten.
English: Opinion following an Article 350F referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses EMA/106359/2015
Danish: Udtalelse efter en artikel 35-indbringelse0F for veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske til anvendelse hos heste EMA/106359/2015
English: Therefore, on 6 November 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Danish: Udvalget vedtog derfor den 6. november 2014 enstemmigt en positiv udtalelse, der anbefaler ændring af betingelserne for markedsføringstilladelserne for veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske, opløsning, til anvendelse hos heste.
English: On 14 February 2014, Denmark presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Danish: Den 14. februar 2014 foretog Danmark i medfør af artikel 35 i direktiv 2011/82/EF en indbringelse vedrørende veterinærlægemidler, der indeholder gentamicin og dispenseres som injektionsvæske, opløsning, til heste.
English: Opinion following an Article 351 referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses
Danish: Udtalelse efter en artikel 35-indbringelse for veterinærlægemidler indeholdende gentamicin dispenseret som injektionsvæske til anvendelse hos heste
English: < PC {number} [product code]
Danish: <PC {nummer} [produktkode]
English: At the request of the European Medicines Agency;
Danish: på anmodning fra Det Europæiske Lægemiddelagentur
English: <There are also links to other websites about rare diseases and treatments.>
Danish: <Der er også links til andre websteder om sjældne sygdomme og om, hvordan de behandles.>
English: Risk management plan (RMP)
Danish: Risikostyringsplan (RMP)
English: <This product contains cells of <human> <animal> origin.>
Danish: <Dette lægemiddel indeholder celler af <human> <animalsk> oprindelse.>
English: <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...>
Danish: <...> <6 måneder> <...> <1 år> <18 måneder> <2 år> <30 måneder> <3 år> <...>
English: NN {number} [national reimbursement number or other national number identifying the medicinal product]>
Danish: NN {nummer} [nationalt refusionsnummer eller andet nationalt nummer, der identificerer lægemidlet]>
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.>
Danish: I henhold til artikel 114 i direktiv 2001/83/EF foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.>
English: Pharmacotherapeutic group: {group}, ATC code: <{code}> <not yet assigned>
Danish: Farmakoterapeutisk klassifikation: {kategori}, ATC-kode: <{kode}> <endnu ikke tildelt.>
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.>
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn og batchnummer tydeligt registreres.>
English: <{(Invented) name} is a biosimilar medicinal product.
Danish: <{(Sær)navn} er et biosimilært lægemiddel.
English: Periodic safety update reports (PSURs)
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: <No data are available.>
Danish: <Der foreligger ingen data.>
English: <X contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Danish: <{X} indeholder samme aktive stof og virker på samme måde som et ”referencelægemiddel”, der allerede er godkendt i EU.
English: <Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.>
Danish: <Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogent potentiale samt reproduktions- og udviklingstoksicitet.>
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.>
Danish: <Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.>
English: <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Danish: <4.8> <5.1> <5.2>, men der kan ikke gives nogen anbefalinger vedrørende dosering.>
English: <The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.>
Danish: <Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.>
English: <2.2 Qualitative and quantitative composition> [For advanced therapy products only]
Danish: <2.2 Kvalitativ og kvantitativ sammensætning> [Kun for lægemidler til avanceret terapi]
English: <An updated RMP shall be submitted by {CHMP agreed deadline}.>
Danish: <En opdateret RMP skal fremsendes senest {tidsfrist fastsat af CHMP}.>
English: <The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.>
Danish: <På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.>
English: <Non-interventional post-authorisation safety study (PASS):>>
Danish: < Ikke-interventionelle sikkerhedsstudier efter tilladelse til markedsføring (PASS):>
English: <Additional risk minimisation measures>
Danish: <Yderligere risikominimeringsforanstaltninger>
English: <This leaflet is available in all EU/EEA languages on the European Medicines Agency website.>
Danish: <Denne indlægsseddel findes på alle EU-/EØS-sprog på Det Europæiske Lægemiddelagenturs hjemmeside.>
English: 6.5 Nature and contents of container <and special equipment for use, administration or implantation>
Danish: Emballagetype og pakningsstørrelser <og specielt udstyr til anvendelse, administration eller implantation>
English: <Postauthorisation efficacy study (PAES):>
Danish: <Virkningsstudie efter tilladelse til markedsføring (PAES):>
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.*
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V*.
English: <Name and address of the manufacturer(s) of the biological active substance(s)
Danish: <Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer)
English: <Environmental risk assessment (ERA)>
Danish: <Miljørisikovurdering>
English: <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:>
Danish: <Følgende bivirkninger er ikke observeret i kliniske studier, men er set i dyreforsøg efter eksponeringsniveauer, der svarer til kliniske eksponeringsniveauer, og kan muligvis være klinisk relevante:>
English: <2.1 General description> [For advanced therapy products only]
Danish: <2.1 Generel beskrivelse> [Kun for lægemidler til avanceret terapi]
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP {ART/TYPE}
English: <This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:>
Danish: <Dette er en godkendelse under særlige vilkår, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:>
English: <Official batch release
Danish: <Officiel batchfrigivelse
English: <The requirements for submission of PSURs 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 web-portal.>
Danish: <Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.>
English: <This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:>
Danish: <Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14-a, stk. 4, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:>
English: <Traceability
Danish: <Sporbarhed
English: Description Due date
Danish: Beskrivelse Tidsfrist
English: A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. <FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG> FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.>
Danish: <I non-kliniske studier blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i tilstrækkelig grad.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER {ART/TYPE}
English: See the end of section 4 for how to report side effects.> [For medicinal products subject to additional monitoring ONLY]
Danish: Se sidst i <afsnit> <punkt> 4, hvordan <De> <du> indberetter bivirkninger.> [KUN for lægemidler, der er underlagt supplerende overvågning]
English: See section 4.8 for how to report adverse reactions.> [For medicinal products subject to additional monitoring ONLY]
Danish: 4.8, hvordan bivirkninger indberettes.> [KUN for lægemidler, der er underlagt supplerende overvågning]
English: PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING>
Danish: MÆRKNING, DER SKAL ANFØRES <PÅ DEN YDRE EMBALLAGE> <OG> <PÅ DEN INDRE EMBALLAGE> {ART/TYPE}
English: <{(Invented) name} has <no or negligible influence> <minor influence> <moderate influence> <major influence> on the ability to drive and use machines.>
Danish: <{X} påvirker <ikke eller kun i ubetydelig grad> <i mindre grad> <i moderat grad> <i væsentlig grad> evnen til at føre motorkøretøj og betjene maskiner.>
English: Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <…> <after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.>
Danish: <Tag> <Brug> ikke <{X}> <lægemidlet> efter den udløbsdato, der står på <etiketten> <æsken> <beholderen> <…> <efter {angiv forkortelsen for udløbsdatoen}>.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.>
Danish: Yderligere oplysninger findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.>
English: <The European Medicines Agency has deferred the obligation to submit the results of studies with <{(Invented) name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in one or more subsets of the paediatric population in {condition, as per paediatric investigation plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Danish: <Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med <{(sær)navn}> [for generiske lægemidler: <referencelægemidlet, som indeholder {navn på de(t) aktive stof(fer)},>] i en eller flere undergrupper af den pædiatriske population <ved> <med> {tilstand i den godkendte indikation i henhold til afgørelsen i den pædiatriske undersøgelsesplan (PIP)} (se pkt.
English: <The reference medicinal product containing {active substance} has been authorised under ‘exceptional circumstances'.
Danish: <Referencelægemidlet, der indeholder {aktivt stof} er godkendt under ”særlige vilkår”.
English: <Obligation to conduct post-authorisation measures
Danish: <Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse>
English: <The European Medicines Agency has waived the obligation to submit the results of studies with <{(Invented) name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in all subsets of the paediatric population in {condition as per paediatric investigation plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Danish: <Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med <{(sær)navn}> [for generiske lægemidler: <referencelægemidlet, som indeholder {navn på de(t) aktive stof(fer)},>] i alle undergrupper af den pædiatriske population <ved> <med> {tilstand i den godkendte indikation i henhold til afgørelsen i den pædiatriske undersøgelsesplan (PIP)} (se pkt.
English: Talk to your doctor <or> <,> <pharmacist> <or nurse> before <taking> <using> X
Danish: Kontakt lægen<,> <eller> <apotekspersonalet> <eller sygeplejersken>, før <De> <du> <tager> <bruger> {X}.
English: <Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.>
Danish: <Fortæl <altid> <det altid til> <lægen> <eller apotekspersonalet>, hvis <De> <du> <tager> <bruger> anden medicin, for nylig har <taget> <brugt> anden medicin eller planlægger at <tage> <bruge> anden medicin.>
English: <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3.>
Danish: <Opbevaringsforhold efter <rekonstitution> <fortynding> <anbrud> af lægemidlet, se pkt.
English: The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for X, such as this leaflet.>
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om referencelægemidlet, og eventuelle opdateringer for referencelægemidlet vil om nødvendigt også blive inkluderet i produktinformationen for {X}, såsom i denne indlægsseddel>.