FrancophonIA/ELRC3.0 huggingface dataset:
English: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomized phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Danish: Børn: I studie I2301 blev der inkluderet i alt 93 børn, unge og yngre voksne (fra 1 til 22 år) med Ph+ ALL i et åbent, multicenter, ikke-radomiseret fase III sekventielt kohorte-forsøg.
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Danish: Forhøjet serumkreatinin, forhøjet serumkreatinfosfokinase og forhøjet serumlaktatdehydrogenase, forhøjet alkalisk fosfatase
English: Haematological response Complete haematological response (CHR) No evidence of leukaemia
Danish: Hæmatologisk respons1 Fuldstændigt hæmatologisk respons (CHR) Intet tegn på leukæmi (NEL) Remission til kronisk fase (RTC)
English: Additionally Imatinib Accord 400 mg tablets are available in PVC/PVdC/Alu perforated unit dose blister in pack-sizes of 30x1, 60x1 or 90x1 film-coated tablets.
Danish: Desuden kan Imatinib Accord 400 mg tabletter fås i perforeret enhedsdosis-blister af PVC/PVdC/alu i pakningsstørrelser med 30 x 1, 60 x 1 eller 90 x 1 filmovertrukne tabletter.
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the
Danish: 6-MP (75 mg/m2/dag, p.o.): dag 11-56 (tilbagehold 6-MP i de 6-10 dage med kraniebestråling med start dag 1 i cyklus 5.
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Danish: Plasmaeksponeringen af levothyroxin kan muligvis mindskes, når Imatinib gives samtidig til thyreoidektomerede patienter (se pkt.
English: Additionally Imatinib Accord 100 mg tablets are also available in PVC/PVdC/Alu perforated unit dose blister in pack-sizes of 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.
Danish: Desuden kan Imatinib Accord 100 mg tabletter fås i perforeret enhedsdosis-blister af PVC/PVdC/alu i pakningsstørrelser med 30 x 1, 60 x 1, 90 x 1, 120 x 1 eller 180 x 1 filmovertrukne tabletter.
English: One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.In addition, children and adolescents have been treated in two phase I studies and one phase II study.
Danish: Der er gennemført en større, åben, international, randomiseret, fase III multicenterundersøgelse med patienter med nydiagnosticeret Ph+ CML.
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Danish: ARA-C (3 g/m2/dosis q 12 h x 4, i.v.
English: The recommended dose of Imatinib Accord is 400 mg/day for adult patients with MDS/MPD.
Danish: Dosering ved MDS/MPD Den anbefalede dosis af Imatinib Accord er 400 mg/dag til voksne patienter med MDS/MPD.
English: Imatinib Accord 400 mg tablets
Danish: Imatinib Accord 400 mg tabletter
English: The dose is 800 mg per day (to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.
Danish: Dosis er 800 mg pr. dag, som skal tages som 4 tabletter à 100 mg eller én tablet à 400 mg om morgenen og 4 tabletter à 100 mg eller én tablet à 400 mg om aftenen.
English: Imatinib Accord 400 mg film-coated tablets are brownish orange, oval shaped, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T2' on either side of breakline and plain on the other side.
Danish: Imatinib Accord 400 mg filmovertrukne tabletter er brun-orange, ovale, bikonvekse filmovertrukne tabletter, præget med ‘IM' og ‘T2' på hver sin side af delekærven på den ene side, jævne på den anden.
English: Imatinib Accord 100 mg film-coated tablets are brownish orange, round biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T1' on either side of breakline and plain on the other side.
Danish: Imatinib Accord 100 mg filmovertrukne tabletter er brun-orange, runde, bikonvekse filmovertrukne tabletter, præget med ‘IM' og ‘T1' på hver sin side af delekærven på den ene side, jævne på den anden side.
English: In the event of recurrence of ANC < 1.0 x 109/1 and/or platelets < 50 x 109/1, repeat step 1 and resume Imatinib Accord at reduced dose of 260 mg/m2.
Danish: I tilfælde af recidiverende ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Accord i en reduceret dosis på 260 mg/m2.
English: How to take Imatinib Accord
Danish: Sådan skal du tage Imatinib Accord
English: Posology for MDS/MPD
Danish: Hvis du behandles for MDS/MPD
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children and adolescents (based on AUC) at 340 mg/m2/day.
Danish: Renale adenomer/carcinomer, papillomaer i blæren og urinrøret, adenocarcinomer i tyndtarmen, adenomer i bisskjoldbruskkirtlerne, de benigne og maligne tumorer i binyremarven og ikkekirtellignende ventrikelpapillomaer/carcinomer blev observeret ved 60 mg/kg/dag.
English: This medicinal product does not require any special storage conditions.
Danish: Alu/alu-blister: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume Imatinib Accord at reduced dose of 300 mg.
Danish: I tilfælde af recidiverende ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Accord i en reduceret dosis på 300 mg.
English: Overall, in patients receiving first-line Imatinib, the average daily dose delivered was 406 ± 76 mg.
Danish: Overordnet var den gennemsnitlige daglige dosis 406 ± 76 mg hos patienter, der fik Imatinib som førstevalg.
English: (3 h, q 12 h), days 1-3; Vincristine 2 mg i.v., days 4, 11;
Danish: (3 timer, q 12 timer), dag 1-3; vinkristin 2 mg i.v., dag 4, 11; doxorubicin 50 mg/m2 i.v.
English: Imatinib is mainly metabolised through the liver.
Danish: Leverinsufficiens: Imatinib metaboliseres primært i leveren.
English: The recommended dose of Imatinib Accord is 100 mg/day for adult patients with HES/CEL.
Danish: Dosering ved HES/CEL Den anbefalede dosis af Imatinib Accord er 100 mg/dag til voksne patienter med HES/CEL.
English: Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Danish: Hver filmovertrukket tablet indeholder 400 mg imatinib (som mesilat).
English: - Patients who are concerned about their fertility while taking Imatinib Accord are advised to consult with their doctor.
Danish: - Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib Accord, skal du kontakte din læge.
English: ANC < 1.0x109/l and/or platelets < 50 x 109/l
Danish: ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l
English: • Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
Danish: • Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm sygdomme).
English: Not applicable
Danish: Ikke relevant Ikke relevant
English: If you forget to take Imatinib Accord
Danish: Hvis du har taget for meget Imatinib Accord
English: Study ADE10 Prephase
Danish: Studie ADE10
English: Blood and lymphatic system disorders Very common Neutropenia, thrombocytopenia, anaemia Common
Danish: Meget almindelig Neutropeni, trombocytopeni, anæmi Almindelig
English: Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets imatinib
Danish: Imatinib Accord 100 mg filmovertrukne tabletter Imatinib Accord 400 mg filmovertrukne tabletter imatinib
English: Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Danish: Aktive stoffer der kan reducere plasmakoncentrationen af imatinib Stoffer, der inducerer CYP3A4-aktivitet (f.eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon eller perikon (Hypericum perforatum), kan signifikant reducere følsomheden for Imatinib og dermed potentielt øge risikoen for terapeutisk svigt.
English: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Imatinib Accord - hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i Imatinib Accord
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3, 4, 5;
Danish: DEX 10 mg/m2 oral, dag 1-5; CP 200 mg/m2 i.v., dag 3, 4, 5; MTX
English: NAME OF THE MEDICINAL PRODUCT Imatinib Accord 400 mg film-coated tablets imatinib
Danish: LÆGEMIDLETS NAVN Imatinib Accord 400 mg filmovertrukne tabletter imatinib
English: The recommended dose of Imatinib is 800 mg/day for adult patients with DFSP.
Danish: Dosering ved DFSP Den anbefalede dosis af Imatinib er 800 mg/dag til voksne patienter med DFSP.
English: Confusional state Nervous system disorders Very common Headache2
Danish: Meget almindelig Hovedpine2 Almindelig
English: NAME OF THE MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets imatinib
Danish: LÆGEMIDLETS NAVN Imatinib Accord 100 mg filmovertrukne tabletter imatinib
English: Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg imatinib (as mesilate).
Danish: Hver Imatinib Accord 400 mg tablet indeholder 400 mg imatinib (som mesilat).
English: For PVC/PVdC/Alu blisters Do not store above 30C.
Danish: PVC/PVdC/alu-blister: Må ikke opbevares ved temperaturer over 30°C.
English: In the event of recurrence of ANC < 1.0x109/1 and/or platelets < 50x109/1, repeat step1 and resume Imatinib Accordat reduced dose of 400 mg.
Danish: I tilfælde af tilbagevenden af ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentages trin 1 og Imatinib Accord reintroduceres med nedsat dosering på 400 mg.
English: Haemolytic anaemia, thrombotic microangiopathy
Danish: Hæmolytisk anæmi, trombotisk mikroangiopati Metabolisme og ernæring Almindelig
English: Brownish orange, round, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T1' on either side of breakline and plain on the other side.
Danish: Brun-orange, runde, bikonvekse filmovertrukne tabletter, præget med ‘IM' og ‘T1' på hver sin side af delekærven på den ene side, jævne på den anden side.
English: These patients received imatinib for a median of 47 months (range 24 days - 60 months).
Danish: Disse patienter fik imatinib i en periode varierende mellem 24 dage og
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Danish: Stomatitis, mundulcera, gastrointestinalblødning7, sure opstød, melæna,
English: Imatinib Accord 100 mg film-coated tablets
Danish: Imatinib Accord 100 mg filmovertrukne tabletter
English: - The active substance is imatinib mesilate.
Danish: Imatinib Accord indeholder: - Aktivt stof: imatinibmesilat.
English: Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3publications.
Danish: I tre publikationer var der rapporteret om tre (3) patienter med HES og CEL forbundet med PDGFR-omlejring.
English: Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Danish: Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse
English: Brownish orange, oval shaped, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T2' on either side of breakline and plain on the other side.
Danish: Brun-orange, ovale, bikonvekse filmovertrukne tabletter, præget med ‘IM' og ‘T2' på hver sin side af delekærven på den ene side, jævne på den anden.
English: MTX 15 mg intrathecal, day1;
Danish: 12 mg intrathecal, dag 1
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg imatinib (as mesilate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 400 mg imatinib (som mesilat).
English: What Imatinib Accord is and what it is used for What you need to know before you take Imatinib Accord How to take Imatinib Accord Possible side effects
Danish: Det skal du vide, før du begynder at tage Imatinib Accord Sådan skal du tage Imatinib Accord Bivirkninger
English: aANC < 0.5x109/1 and/or platelets < 10 x 109/1
Danish: aANC<0,5 x 109/l og/eller trombocytter <10 x 109/l
English: Hyperkalaemia, hypomagnesaemia Psychiatric disorders Common
Danish: Hyperkaliæmi, hypomagnesiæmi
English: Imatinib Accord 400 mg film-coated tablets
Danish: Imatinib Accord 400 mg filmovertrukne tabletter
English: Other medicines and Imatinib Accord
Danish: Den sædvanlige dosis af Imatinib Accord er
English: SPECIAL STORAGE CONDITIONS For PVC/PVdC/Alu blisters Do not store above 30C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER PVC/PVdC/alu-blister:
English: Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking imatinib.
Danish: Hos ca. 2,5% af nyligt diagnosticerede CML-patienter i behandling med imatinib er der rapporteret tilfælde af svær væskeretention (pleuraeksudat, ødem, pulmonalt ødem,ascites, perifert ødem).
English: If your daily dose is 800 mg (8 tablets of 100 mg or 2 tablets of 400 mg).
Danish: Hvis din daglige dosis er 800 mg (8 tabletter à 100 mg eller to tabletter à 400 mg), skal du tage 4 tabletter à 100 mg eller én tablet à 400 mg om morgenen og 4 tabletter à 100 mg eller én tablet à 400 mg om aftenen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg imatinib (as mesilate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 100 mg imatinib (som mesilat).
English: Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common Periorbital oedema, dermatitis/eczema/rash Common
Danish: Meget almindelig Periorbitalt ødem, dermatitis/eksem/udslæt Almindelig
English: The recommended dosage of Imatib Accord is 400 mg/day for adult patients in chronic phase CML.
Danish: Dosering ved CML hos voksne patienter Den anbefalede dosis af Imatinib er 400 mg/dag til voksne patienter med CML i kronisk fase.
English: Each 100 mg film-coated tablet of Imatinib Accorcd ontains 100 mg imatinib (as mesilate).
Danish: Hver Imatinib Accord 100 mg tablet indeholder 100 mg imatinib (som mesilat).
English: Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Danish: dag 1, 8, 15, 22; Ara-C 40 mg intrathecal, dag 1, 8, 15, 22; methylprednisolon 40 mg intrathecal, dag 1, 8, 15, 22
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/001-004
Danish: Imatinib Accord 100 mg tabletter EU/1/13/845/001-004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/009-011
Danish: Imatinib Accord 400 mg tabletter EU/1/13/845/009-011
English: If you are being treated for Ph-positive ALL The starting dose is 600 mg to be taken as 6 tablets of 100 mg or one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Danish: Startdosis er 600 mg, som skal tages som 6 tabletter à 100 mg eller én tablet à 400 mg plus to tabletter à 100 mg én gang daglig.
English: Increased hepatic enzymes
Danish: Forhøjet serumamylase
English: During treatment with Imatinib Accord, tell your doctor straight away if you put on weight very quickly.
Danish: Brug af anden medicin sammen med Imatinib Accord Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Study AUS01
Danish: Studie AUS01 Induktionskonsoliderende behandling
English: Polyethylene glycol Iron oxide yellow (E172) Iron oxide red (E172)
Danish: Hypromellose 6 cps (E464) Talkum (E553b) Polyethylenglycol Jernoxid, gul (E 172) Jernoxid, rød (E 172)
English: Respiratory, thoracic and mediastinal disorders Common
Danish: Trombose/emboli* Luftveje, thorax og mediastinum Almindelig
English: (24 h), day 4;
Danish: ): dag 4
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Danish: Daunorubicin 30 mg/m2 i.v., dag 1-3, 15-16; VCR 2 mg total dose i.v., dag 1, 8, 15, 22; CP 750 mg/m2 i.v., dag 1, 8; prednison 60 mg/m2 oral, dag 1-7, 15-21; IDA 9 mg/m2 oral, dag 1-28; MTX 15 mg intrathecal,
English: Table 1 Tabulated summary of adverse reactions Infections and infestations Uncommon
Danish: Tabel 1 Opsummering af bivirkninger
English: Patients with Severe renal impairment should be treated with caution.
Danish: Der bør udvises forsigtighed ved behandling af patienter med svært nedsat nyrefunktion.
English: If you are being treated for MDS/MPD The starting dose is 400 mg to be taken as 4 tablets of 100 mg or one tablet of 400 mg once a day.
Danish: Startdosis er 400 mg, som skal tages som 4 tabletter à 100 mg eller én tablet à 400 mg én gang daglig.
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x
Danish: ): dag 1 og 15 Leucovorin (75 mg/m2 i time 36, i.v.
English: Consolidation therapy DEX 10 mg/ m2oral, days 1-5; Vindesine 3 mg/ m2 i.v., day 1;
Danish: DEX 10 mg/m2 oral, dag 1-5; vindesin 3 mg/m2 i.v., dag 1; MTX 1,5 g/m2 i.v.
English: NAME OF MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets
Danish: Imatinib Accord 100 mg filmovertrukne tabletter Imatinib Accord 400 mg filmovertrukne tabletter
English: WBC < 10 x 109/l, platelet < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement
Danish: RTC: <15 % blaster i BM og PB, <30 % blaster + promyelocytter i BM og PB, <20 % basofilocytter i
English: Daunorubicin 45 mg/ m2 i.v., days 6-7, 13-14
Danish: DEX 10 mg/m2 oral, dag 1-5; VCR 2 mg i.v., dag 6, 13, 20; daunorubicin 45 mg/m2 i.v., dag 6-7, 13-14
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Danish: : dag 1, 29 DEX (6 mg/m2/dag, p.o.): dag 1-5; 29-33 6-MP (75 mg/m2/dag, p.o.): dag 1-56 Methotrexat (20 mg/m2/uge, p.o.): dag 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyt-koloni-stimulerende faktor, VP-16 = etoposid, MTX = methotrexat, i.v.
English: urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Danish: Målorganerne for neoplastiske ændringer var nyrerne, urinblæren, urinrøret, fedtkirtlerne på forhuden og klitoris, tyndtarmen, bisskjoldbruskkirtlerne, binyrererne og den ikkekirtellignende del af maven.
English: MTX (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Danish: DEX (6 mg/m2/dag p.o.): dag 1-5; 29-33 6-MP (75 mg/m2/dag, p.o.): dag 8-28
English: Prednisolone 60 mg/ m2/day oral
Danish: DEX (6 mg/m2/dag,p.o.
English: Vincristine 1.3 mg/ m2 i.v., days 1, 8, 15, 21;
Danish: (1 time), dag 1-3; vinkistin 1,3 mg/m2 i.v., dag 1, 8, 15, 21; prednisolon 60 mg/m2/dag oral
English: 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.
Danish: 400 mg som skal tages som 4 tabletter à 100 mg eller én tablet af 400 mg én gang daglig.
English: Pericarditis*, cardiac tamponade* Vascular disorders4
Danish: Perikardit*, hjertetamponade*
English: granulocyte-colony-stimulating factor (G-CSF).
Danish: der hedder granulocyt-koloni-stimulerende faktor (F-CSF).
English: What was Efgratin expected to be used for?
Danish: Hvad forventedes Efgratin anvendt til?
English: On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Efgratin, for reducing neutropenia.
Danish: Den 16. november 2016 meddelte Gedeon Richter Plc officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Efgratin til behandling af neutropeni.
English: Efgratin was developed as a ‘biosimilar' medicine.
Danish: Efgratin blev udviklet som et "biosimilært" lægemiddel.
English: A further study in patients receiving cancer medicines compared the safety and effectiveness of Efgratin and Neulasta.
Danish: En yderligere undersøgelse af patienter, der fik kræftmedicin, sammenlignede sikkerheden ved og virkningen af Efgratin og Neulasta.
English: What is Efgratin?
Danish: Hvad er Efgratin?
English: Efgratin is a medicine that contains the active substance pegfilgrastim, which stimulates the production of neutrophils (a type of white blood cell that fights infections).
Danish: Efgratin er et lægemiddel, der indeholder det aktive stof pegfilgrastim, som stimulerer dannelsen af neutrofiler (en type hvide blodlegemer, der bekæmper infektioner).
English: The active substance in Efgratin, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Danish: Det aktive stof i Efgratin, pegfilgrastim, består af filgrastim, der er blevet pegyleret, dvs. forbundet til et kemisk stof, der hedder polyethylenglykol.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Efgratin could not have been approved for reducing neutropenia.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Efgratin ikke kunne godkendes til behandling af neutropeni.
English: The company presented results of studies in healthy people designed to show that Efgratin is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Danish: Virksomheden fremlagde resultaterne af undersøgelser hos raske personer for at vise, at Efgratin i høj grad svarer til referencelægemidlet Neulasta, hvad angår stoffets kemiske struktur, renhed og virkningsmekanisme samt kroppens håndtering af lægemidlet.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Efgratin?
English: The CHMP was concerned that study results had not shown that Efgratin was handled by the body in the same way as the reference medicine Neulasta.
Danish: CHMP var betænkelig ved, at resultaterne af undersøgelserne ikke havde vist, at Efgratin blev håndteret på samme vis i kroppen som referencelægemidlet Neulasta.
English: How does Efgratin work?
Danish: Hvordan virker Efgratin?
English: This means that Efgratin was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Neulasta.
Danish: Det betyder, at det var hensigten, at Efgratin skulle svare til og indeholde det samme aktive stof som et biologisk lægemiddel, der allerede er godkendt i Den Europæiske Union ("referencelægemidlet").
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not demonstrated that Efgratin is highly similar to Neulasta.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde påvist, at Efgratin i høj grad svarer til referencelægemidlet Neulasta.