FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was the duration of severe neutropenia.
Danish: Virkningen blev hovedsageligt bedømt på varigheden af alvorlig neutropeni.
English: In addition, a study in 279 female adult patients with breast cancer who were being treated with cancer medicines showed that Nivestim is comparable to the reference medicine, Neupogen.
Danish: Endvidere viste et studie, som omfattede 279 voksne kvindelige patienter med brystkræft, der blev behandlet med kræftlægemidler, at Nivestim var sammenligneligt med referencelægemidlet, Neupogen.
English: The most common side effects with Nivestim (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Nivestim (der kan forekomme hos mere end 1 ud af 10 personer) er feber, smerter i muskler og knogler, anæmi (lavt antal røde blodlegemer), opkastning og kvalme.
English: What are the risks associated with Nivestim?
Danish: Hvilke risici er der forbundet med Nivestim?
English: Nivestim is a ‘biosimilar' medicine.
Danish: Nivestim er et "biosimilært" lægemiddel.
English: Side effects reported with Nivestim are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Nivestim vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The way Nivestim is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Danish: Indgivelsesvejen, dosen og varigheden af behandlingen med Nivestim afhænger af den sygdom, som det anvendes til, samt patientens kropsvægt og respons på behandlingen.
English: The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Danish: Det aktive stof i Nivestim, filgrastim, svarer stort set til et humant protein kaldet granulocytkolonistimulerende faktor (G-CSF).
English: For more information about using Nivestim, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Nivestim, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The reference medicine for Nivestim is Neupogen.
Danish: Referencelægemidlet for Nivestim er Neupogen.
English: Nivestim is a medicine that stimulates the production of white blood cells and is used:
Danish: Nivestim er et lægemiddel, der stimulerer dannelsen af hvide blodlegemer, og det anvendes til:
English: Because Nivestim is a biosimilar medicine the studies on effectiveness and safety of filgrastim carried out with Neupogen do not all need to be repeated for Nivestim.
Danish: Da Nivestim er et biosimilært lægemiddel, behøver de studier af filgrastims virkning og sikkerhed, der er udført for Neupogen, ikke alle at blive gentaget for Nivestim.
English: The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.
Danish: I hovedstudiet havde de patienter, som fik Nivestim, svær neutropeni i en lige så lang tidsperiode som de patienter, der fik Neupogen.
English: The medicine is available in pre-filled syringes and is given by injection under the skin or infusion (drip) into a vein.
Danish: Lægemidlet fås som fyldte sprøjter og gives ved injektion under huden eller som infusion (drop) i en blodåre.
English: The safety of Nivestim has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neupogen.
Danish: Sikkerheden ved Nivestim er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne ved referencelægemidlet, Neupogen.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Nivestim has a highly similar structure, purity and biological activity to Neupogen and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Nivestim har en struktur, renhed og biologisk aktivitet, der svarer til Neupogens, og at det fordeles i kroppen på samme måde.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes).
Danish: • at reducere varigheden af neutropeni (lavt antal neutrofiler, der er en type hvide blodlegemer) og til at forebygge febril neutropeni (neutropeni med feber) hos kræftpatienter (bortset fra patienter med kronisk myeloid leukæmi eller myelodysplastisk syndrom).
English: All these data were considered sufficient to conclude that Nivestim will behave in the same way as Neupogen in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Nivestim vil have de samme egenskaber som Neupogen, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: Laboratory studies comparing Nivestim with Neupogen have shown that the active substance in Nivestim is highly similar to that in Neupogen in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, hvor Nivestim sammenlignes med Neupogen, har vist, at det aktive stof i Nivestim i meget høj grad svarer til Neupogen, hvad angår struktur, renhed og biologisk aktivitet.
English: Therefore, the Agency's view was that, as for Neupogen, the benefits of Nivestim are greater than its risks and it can be authorised or use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Nivestim opvejer risiciene, som for Neupogen, og at det kan godkendes til anvendelse i EU.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Danish: • til at øge neutrofiltallet og reducere risikoen for infektioner hos patienter med neutropeni, der tidligere har haft gentagne og svære infektioner
English: For the full list of side effects and restrictions with Nivestim, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Nivestim fremgår af indlægssedlen.
English: Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen.
Danish: Studier har desuden vist, at behandling med Nivestim frembringer en tilsvarende mængde aktivt stof i kroppen som behandling med Neupogen.
English: How is Nivestim used?
Danish: Hvordan anvendes Nivestim?
English: What benefits of Nivestim have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nivestim?
English: infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Danish: • til behandling af vedvarende neutropeni hos patienter med fremskreden hivinfektion for at reducere risikoen for bakterielle infektioner, når andre former for behandling ikke er egnede.
English: How does Nivestim work?
Danish: Hvordan virker Nivestim?
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Danish: • til at reducere varigheden af neutropeni hos patienter, der er i behandling, for at tilintetgøre knoglemarvsceller inden en knoglemarvstransplantation (såsom hos visse patienter med leukæmi),
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nivestim have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nivestim.
English: The first European approval was in NL on 29 May 1981.
Danish: Den første europæiske godkendelse var i NL den 29. maj 1981.
English: The pregnancy section has been revised in line with the relevant guideline[9].
Danish: Afsnittet om graviditet er revideret i henhold til den relevante vejledning[9].
English: The product was subsequently approved in AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI and UK.
Danish: Produktet blev efterfølgende godkendt i AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI og UK.
English: The safety and efficacy of Vepesid and associated names in children below 18 years of age have not been established.
Danish: Sikkerheden og virkningen af Vepesid og relaterede navne hos børn under 18 år er ikke fastlagt.
English: Based on data on bioavailability[1][2], the recommended oral dose is 100 to 200 mg/m2/day on day 1-5 in a cycle of 21 or 28 days; or 200 mg/m2/day on three days (most often days 1-3 or day 1, 3, and 5) in a cycle of 21 or 28 days.
Danish: Baseret på data om biotilgængeligheden[1][2] er den anbefalede orale dosis 100-200 mg/m2/dag på dag 1-5 i en cyklus på 21 eller 28 dage, eller 200 mg/m2/dag i tre dage (oftest dag 1-3 eller på dag 1, 3 og 5) i en cyklus på 21 eller 28 dage.
English: • The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: • den af markedsføringstilladelsesindehaverne foreslåede produktinformation er blevet vurderet på grundlag af den forelagte dokumentation og den videnskabelige drøftelse i udvalget,
English: Vepesid is available as 50mg and 100 mg capsules for oral use.
Danish: Vepesid dispenseres som 50 mg- og 100 mg-kapsler til oral brug.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Vepesid and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Danish: På grund af de divergerende nationale afgørelser, der var truffet af medlemsstaterne ved godkendelsen af ovenstående produkt, anmeldte Europa-Kommissionen den 14. oktober 2015 en officiel indbringelse til CHMP/Det Europæiske Lægemiddelagentur i medfør af artikel 30 i direktiv 2001/83/EF for Vepesid og relaterede navne med henblik på at få ophævet divergenserne mellem de nationalt godkendte produktinformationer og dermed få produktinformationerne harmoniseret i EU.
English: The coefficient of variation is around 30% for oral administration, versus 10% for intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30-40%).
Danish: Variationskoefficienten er ca. 30 % ved oral administration, mod 10 % ved intravenøs administration (variabiliteten mellem patienter er den samme efter intravenøs og oral administration, dvs. 30-40 %).
English: This is particularly relevant when patients are treated in the curative setting (e.g. for testicular cancer).
Danish: Dette er særlig relevant ved et kurativt behandlingsregime (f.eks. til testikelkræft).
English: The available efficacy data for etoposide in the different indications are based for the most part on studies in which etoposide was used intravenously.
Danish: De foreliggende data om virkning for etoposid ved de forskellige indikationer er for størstedelen baseret på undersøgelser, hvor etoposid er anvendt intravenøst.
English: With regards to lactation, etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) and it has been included as a contraindication.
Danish: Hvad angår amning, udskilles etoposid i mælken (Medications and Mothers' Milk: Thomas W. Hale), og amning er derfor medtaget som kontraindikation.
English: - Acute myeloid leukaemia
Danish: - akut myeloid leukæmi
English: For this reason, it is critical that the advantages of the oral administration route are carefully weighed against the disadvantages of larger within-patient variability in exposure after oral administration, which should be evaluated on an individual basis.
Danish: Det er derfor kritisk afgørende, at fordelene ved oral administration opvejes nøje i forhold til ulemperne ved større intraindividuel variation i eksponering efter oral administration, hvilket bør vurderes individuelt.
English: Lactation has been included as a contraindication, since breastfeeding women could replace breastfeeding by dairy products to feed their child.
Danish: Amning er indsat som kontraindikation, da ammende kvinder kan erstatte amning af barnet med mejeriprodukter.
English: Vepesid contains etoposide, a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Danish: Vepesid indeholder etoposid, der er et semisyntetisk derivat af podophyllotoxin, som bryder dobbeltstrenget DNA gennem interaktion med DNA-topoisomerase II eller gennem dannelse af frie radikaler.
English: • The Committee considered the divergences identified in the notification for Vepesid and associated names, as well as the remaining sections of the product information.
Danish: • udvalget behandlede de divergenser, der var konstateret i anmeldelsen vedrørende Vepesid og relaterede navne samt de øvrige punkter i produktinformationen,
English: In renal impairment (creatinine clearance (CrCl) 15-5 mL/min) a dose reduction of 25% is recommended.
Danish: Ved nedsat nyrefunktion (kreatininclearance 15-5 ml/min) anbefales en dosisreduktion på 25 %.
English: In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[3][4][5][6][7].
Danish: Hos patienter med nedsat nyrefunktion vedtog CHMP at undlade at anbefale dosisreduktion ved kreatininclearance > 50 ml/min, som understøttet af den tilgængelige litteratur[3][4][5][6][7].
English: In particular, for the concomitant use of live vaccines, immunosuppression is a common side effect of etoposide listed as very common in the SmPC.
Danish: Navnlig ved samtidig brug af levende vacciner er immunosuppression en almindelig bivirkning af etoposid og er i produktresuméet opført som meget almindelig.
English: Vepesid and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Danish: Vepesid og relaterede navne er optaget på listen over produkter, der kræver harmonisering af produktresuméet som angivet af CMDh, i overensstemmelse med artikel 30, stk. 2, i direktiv 2001/83/EF.
English: - Recurrent or refractory testicular cancer
Danish: - recidiverende eller refraktær testikelcancer
English: The data in literature for patients with CrCl less than 15 mL/min and on dialysis strongly suggest that further dose reduction is required in these patients as reviewed by Inoue et al. (2004)[8].
Danish: Litteraturdata om dialysepatienter med kreatininclearance under 15 ml/min tyder stærkt på, at der kræves yderligere dosisreduktion hos disse patienter, som det fremgår af oversigtsartiklen af Inoue et al. (2004)[8].
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
Danish: De foretagne ændringer af produktresuméet afspejler sig konsekvent i etiketteringen i relevant omfang, dog er de fleste afsnit overladt til national udarbejdelse.
English: - Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
Danish: - ovariecancer: ikke-epiteliel ovariecancer og platinresistent/-refraktær epiteliel ovariecancer
English: The text on breastfeeding has been amended accordingly.
Danish: Teksten om amning er rettet tilsvarende.
English: The revised indications in section 4.1 of the Summary of Product Characteristics (SmPC) are:
Danish: 4.1 i produktresuméet er:
English: In section 4.3 of the SmPC Contraindications, the inclusions of hypersensitivity and concomitant use of live vaccines have been agreed as these are in line with the SmPC guidelines.
Danish: 4.3 om kontraindikationer er det vedtaget at medtage hypersensitivitet og sideløbende anvendelse af levende vacciner, da dette er i overensstemmelse med retningslinjerne for produktresuméer.
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: within-patient variability, myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Danish: 4.4, hvor de i forvejen var anført i de fleste nationale produktresuméer: intraindividuel variation, myelosuppression, sekundær leukæmi, hypersensitivitet, reaktion på injektionsstedet, lavt serumalbumin, nedsat nyre- og leverfunktion, tumorlysesyndrom og mutagent potentiale.
English: For this reason, the CHMP agreed to include additional information in section 4.2 and 4.4 to inform physicians about the potential disadvantages of oral versus intravenous administration of etoposide.
Danish: 4.2 og 4.4 for at informere læger om de potentielle ulemper ved oral i forhold til intravenøs administration af etoposid.
English: The adult dosing section contains details on monotherapy, combination therapy, an alternative dosing schedule, and dosing adjustments for a low neutrophil count.
Danish: Punktet om dosering til voksne indeholder oplysninger om monoterapi, kombinationsterapi, en alternativ doseringsplan og doseringsjusteringer ved lavt neutrofiltal.
English: It has been found that with oral administration, within-patient variability in exposure (i.e. between cycles) is notably larger than after intravenous administration.
Danish: Det har vist sig, at den intraindividuelle variation i eksponering (dvs. mellem cyklusser) er markant større ved oral end ved intravenøs administration.
English: Increased within-patient variability in exposure may lead to greater variability in the dose-response relationship, i.e., leading to greater variability in patients' sensitivity to experience treatment
Danish: Øget intraindividuel variabilitet i eksponering kan føre til større variation i dosis-responsforholdet, dvs. større variation i patienternes følsomhed over for den oplevede behandlingsrelaterede toksicitet fra cyklus til cyklus, og kan hos nogle patienter potentielt påvirke den overordnede
English: • The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Danish: • udvalget gennemgik alle data, som markedsføringstilladelsesindehaveren har forelagt til underbygning af den foreslåede harmonisering af produktinformationen,
English: - Non-Hodgkin's lymphoma
Danish: - non-Hodgkins lymfom
English: Appendix 3 (EMEA/CHMP/203927/2005).
Danish: Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labellingAppendix 3 (EMEA/CHMP/203927/2005).
English: - Hodgkin's lymphoma
Danish: - Hodgkins lymfom
English: The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Vepesid and associated names (see Annex I).
Danish: • udvalget vedtog en harmoniseret produktinformation for Vepesid og relaterede navne, anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktinformationen fremgår af bilag III for Vepesid og relaterede navne (se bilag I), konkluderede CHMP, at benefit/risk-forholdet for Vepesid og relaterede navne fortsat er positivt under forudsætning af, at de vedtagne ændringer af produktinformationen gennemføres.
English: As regards the posology, all 17 SmPCs state in section 4.2 that the oral dose of etoposide capsules is based on the recommended intravenous (IV) dose and mention the need to consider bioavailability when prescribing, since it varies from patient to patient.
Danish: 4.2, at den orale dosis af etoposid kapsler er baseret på den anbefalede intravenøse (i.v.)
English: With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Danish: 4.6 i produktresuméet) er der tilføjet oplysninger vedrørende kvinder i den fødedygtige alder om antikonception til mænd og kvinder.
English: Other information about Firmagon:
Danish: Andre oplysninger om Firmagon:
English: It contains the active substance degarelix.
Danish: Det indeholder det aktive stof degarelix.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/S on 17 February 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Firmagon til Ferring Pharmaceuticals A/S den 17. februar 2009.
English: This means that patients do not need to take other medicines to block testosterone at the start of treatment.
Danish: Det betyder, at patienterne ikke behøver at tage andre lægemidler for at hæmme testosteron i starten af behandlingen.
English: The full EPAR for Firmagon can be found here.
Danish: Den fuldstændige EPAR for Firmagon findes her.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FIRMAGON EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) FIRMAGON EPAR - sammendrag for offentligheden
English: The effects of Firmagon were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Firmagon blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The Committee recommended that Firmagon be given marketing authorisation
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Firmagon.
English: Treatment starts with two 120-mg injections, followed by single 80-mg injections every month.
Danish: Behandlingen starter med to 120-mg-injektioner efterfulgt af månedlige 80-mg-injektioner.
English: The company that makes Firmagon will make sure that educational materials are provided to all doctors in all Member States who will prescribe the medicine.
Danish: Virksomheden, som fremstiller Firmagon, vil sørge for, at der i alle medlemsstater udleveres informationsmateriale til alle læger, som udskriver lægemidlet.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that Firmagon was as effective as leuprorelin in the main study.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) noterede sig, at Firmagon var lige så effektivt som leuprorelin i hovedundersøgelsen.
English: When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.
Danish: Efter injektion danner Firmagon en gel under huden, hvorfra det aktive stof langsomt frigøres over en periode på nogle uger.
English: Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men with prostate cancer at all stages of the disease.
Danish: Man har sammenlignet to doser Firmagon med leuprorelin i én hovedundersøgelse med 610 mænd med prostatakræft i alle de forskellige stadier af sygdommen.
English: Firmagon must not be injected into a vein or a muscle.
Danish: Firmagon må ikke injiceres i en vene eller en muskel.
English: The most common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and problems at the injection site such as pain and redness.
Danish: De hyppigste bivirkninger ved Firmagon (som optræder hos flere end 1 ud af 10 patienter) er hedeture og problemer ved injektionsstedet, såsom smerter og rødme.