natgillin/translations-raw huggingface dataset:
DEX 10 mg/m2 oral, dag 1-5; CP 200 mg/m2 i.v., dag 3-5; MTX 15 mg intrathecal, dag 1 
DEX 10 mg/ m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3-5; MTX 15mg intrathecal, day 1
Der sås 4. grads neutropeni (ANC <0,5 x 109/l) og trombopeni (trombocyttal <10 x 109/l) hos henholdsvis 3,6% og 1% af patienterne med nydiagnosticeret CML i kronisk fase. 
In newly diagnosed chronic phase CML grade 4neutropenia (ANC < 0.5x109/1) and thrombocytopenia (platelet count < 10x109/1) were observed in 3.6% and < 1% of patients, respectively.
Hæmoragisk corpus luteum/ hæmoragisk ovariecyste Almene symptomer og reaktioner på administrationsstedet Meget almindelig Væskeretention og ødem, træthed Almindelig 
Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administrative site conditions Very common Fluid retention and oedema, fatigue Common
Hvornår og hvordan skal du tage Imatinib Accord - Tag Imatinib Accord sammen med et måltid. 
- Take Imatinib Accord with a meal.
Øre og labyrint Ikke almindelig 
Vitreous haemorrhage* Ear and labyrinth disorders Uncommon
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. 
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.
Forhøjet serumkreatinin, forhøjet serumkreatinfosfokinase og forhøjet serumlaktatdehydrogenase, forhøjet alkalisk fosfatase 
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Hæmatologisk respons1 Fuldstændigt hæmatologisk respons (CHR) Intet tegn på leukæmi (NEL) Remission til kronisk fase (RTC) 
Haematological response Complete haematological response (CHR) No evidence of leukaemia
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. 
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.
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. 
6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the
Plasmaeksponeringen af levothyroxin kan muligvis mindskes, når Imatinib gives samtidig til thyreoidektomerede patienter (se pkt. 
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
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. 
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.
Der er gennemført en større, åben, international, randomiseret, fase III multicenterundersøgelse med patienter med nydiagnosticeret Ph+ CML. 
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.
ARA-C (3 g/m2/dosis q 12 h x 4, i.v. 
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Dosering ved MDS/MPD Den anbefalede dosis af Imatinib Accord er 400 mg/dag til voksne patienter med MDS/MPD. 
The recommended dose of Imatinib Accord is 400 mg/day for adult patients with MDS/MPD.
Imatinib Accord 400 mg tabletter 
Imatinib Accord 400 mg tablets
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. 
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.
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. 
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.
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. 
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.
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. 
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.
Sådan skal du tage Imatinib Accord 
How to take Imatinib Accord
Hvis du behandles for MDS/MPD 
Posology for MDS/MPD
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. 
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.
Alu/alu-blister: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen. 
This medicinal product does not require any special storage conditions.
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. 
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.
Overordnet var den gennemsnitlige daglige dosis 406 ± 76 mg hos patienter, der fik Imatinib som førstevalg. 
Overall, in patients receiving first-line Imatinib, the average daily dose delivered was 406 ± 76 mg.
(3 timer, q 12 timer), dag 1-3; vinkristin 2 mg i.v., dag 4, 11; doxorubicin 50 mg/m2 i.v. 
(3 h, q 12 h), days 1-3; Vincristine 2 mg i.v., days 4, 11;
Leverinsufficiens: Imatinib metaboliseres primært i leveren. 
Imatinib is mainly metabolised through the liver.
Dosering ved HES/CEL Den anbefalede dosis af Imatinib Accord er 100 mg/dag til voksne patienter med HES/CEL. 
The recommended dose of Imatinib Accord is 100 mg/day for adult patients with HES/CEL.
Hver filmovertrukket tablet indeholder 400 mg imatinib (som mesilat). 
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
- Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib Accord, skal du kontakte din læge. 
- Patients who are concerned about their fertility while taking Imatinib Accord are advised to consult with their doctor.
ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l 
ANC < 1.0x109/l and/or platelets < 50 x 109/l
• Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm sygdomme). 
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
Ikke relevant Ikke relevant 
Not applicable
Hvis du har taget for meget Imatinib Accord 
If you forget to take Imatinib Accord
Meget almindelig Neutropeni, trombocytopeni, anæmi Almindelig 
Blood and lymphatic system disorders Very common Neutropenia, thrombocytopenia, anaemia Common
Imatinib Accord 100 mg filmovertrukne tabletter Imatinib Accord 400 mg filmovertrukne tabletter imatinib 
Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets imatinib
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. 
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.
Tag ikke Imatinib Accord - hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i Imatinib Accord 
- if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
DEX 10 mg/m2 oral, dag 1-5; CP 200 mg/m2 i.v., dag 3, 4, 5; MTX 
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3, 4, 5;
LÆGEMIDLETS NAVN Imatinib Accord 400 mg filmovertrukne tabletter imatinib 
NAME OF THE MEDICINAL PRODUCT Imatinib Accord 400 mg film-coated tablets imatinib
Dosering ved DFSP Den anbefalede dosis af Imatinib er 800 mg/dag til voksne patienter med DFSP. 
The recommended dose of Imatinib is 800 mg/day for adult patients with DFSP.
Meget almindelig Hovedpine2 Almindelig 
Confusional state Nervous system disorders Very common Headache2
LÆGEMIDLETS NAVN Imatinib Accord 100 mg filmovertrukne tabletter imatinib 
NAME OF THE MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets imatinib
Hver Imatinib Accord 400 mg tablet indeholder 400 mg imatinib (som mesilat). 
Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg imatinib (as mesilate).
PVC/PVdC/alu-blister: Må ikke opbevares ved temperaturer over 30°C. 
For PVC/PVdC/Alu blisters Do not store above 30C.
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. 
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.
Hæmolytisk anæmi, trombotisk mikroangiopati Metabolisme og ernæring Almindelig 
Haemolytic anaemia, thrombotic microangiopathy
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. 
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.
Disse patienter fik imatinib i en periode varierende mellem 24 dage og 
These patients received imatinib for a median of 47 months (range 24 days - 60 months).
Stomatitis, mundulcera, gastrointestinalblødning7, sure opstød, melæna, 
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Imatinib Accord 100 mg filmovertrukne tabletter 
Imatinib Accord 100 mg film-coated tablets
Imatinib Accord indeholder: - Aktivt stof: imatinibmesilat. 
- The active substance is imatinib mesilate.
I tre publikationer var der rapporteret om tre (3) patienter med HES og CEL forbundet med PDGFR-omlejring. 
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3publications.
Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse 
Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
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. 
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.
12 mg intrathecal, dag 1 
MTX 15 mg intrathecal, day1;
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 400 mg imatinib (som mesilat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg imatinib (as mesilate)
Det skal du vide, før du begynder at tage Imatinib Accord Sådan skal du tage Imatinib Accord Bivirkninger 
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
aANC<0,5 x 109/l og/eller trombocytter <10 x 109/l 
aANC < 0.5x109/1 and/or platelets < 10 x 109/1
Hyperkaliæmi, hypomagnesiæmi 
Hyperkalaemia, hypomagnesaemia Psychiatric disorders Common
Imatinib Accord 400 mg filmovertrukne tabletter 
Imatinib Accord 400 mg film-coated tablets
Den sædvanlige dosis af Imatinib Accord er 
Other medicines and Imatinib Accord
SÆRLIGE OPBEVARINGSBETINGELSER PVC/PVdC/alu-blister: 
SPECIAL STORAGE CONDITIONS For PVC/PVdC/Alu blisters Do not store above 30C.
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). 
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.
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. 
If your daily dose is 800 mg (8 tablets of 100 mg or 2 tablets of 400 mg).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 100 mg imatinib (som mesilat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg imatinib (as mesilate)
Meget almindelig Periorbitalt ødem, dermatitis/eksem/udslæt Almindelig 
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common Periorbital oedema, dermatitis/eczema/rash Common
Dosering ved CML hos voksne patienter Den anbefalede dosis af Imatinib er 400 mg/dag til voksne patienter med CML i kronisk fase. 
The recommended dosage of Imatib Accord is 400 mg/day for adult patients in chronic phase CML.
Hver Imatinib Accord 100 mg tablet indeholder 100 mg imatinib (som mesilat). 
Each 100 mg film-coated tablet of Imatinib Accorcd ontains 100 mg imatinib (as mesilate).
dag 1, 8, 15, 22; Ara-C 40 mg intrathecal, dag 1, 8, 15, 22; methylprednisolon 40 mg intrathecal, dag 1, 8, 15, 22 
Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Imatinib Accord 100 mg tabletter EU/1/13/845/001-004 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/001-004
Imatinib Accord 400 mg tabletter EU/1/13/845/009-011 
MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/009-011
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. 
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.
Forhøjet serumamylase 
Increased hepatic enzymes
Brug af anden medicin sammen med Imatinib Accord Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
During treatment with Imatinib Accord, tell your doctor straight away if you put on weight very quickly.
Studie AUS01 Induktionskonsoliderende behandling 
Study AUS01
Hypromellose 6 cps (E464) Talkum (E553b) Polyethylenglycol Jernoxid, gul (E 172) Jernoxid, rød (E 172) 
Polyethylene glycol Iron oxide yellow (E172) Iron oxide red (E172)
Trombose/emboli* Luftveje, thorax og mediastinum Almindelig 
Respiratory, thoracic and mediastinal disorders Common
): dag 4 
(24 h), day 4;
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, 
VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Tabel 1 Opsummering af bivirkninger 
Table 1 Tabulated summary of adverse reactions Infections and infestations Uncommon
Der bør udvises forsigtighed ved behandling af patienter med svært nedsat nyrefunktion. 
Patients with Severe renal impairment should be treated with caution.
Startdosis er 400 mg, som skal tages som 4 tabletter à 100 mg eller én tablet à 400 mg én gang daglig. 
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.
): dag 1 og 15 Leucovorin (75 mg/m2 i time 36, i.v. 
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
DEX 10 mg/m2 oral, dag 1-5; vindesin 3 mg/m2 i.v., dag 1; MTX 1,5 g/m2 i.v. 
Consolidation therapy DEX 10 mg/ m2oral, days 1-5; Vindesine 3 mg/ m2 i.v., day 1;
Imatinib Accord 100 mg filmovertrukne tabletter Imatinib Accord 400 mg filmovertrukne tabletter 
NAME OF MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets
RTC: <15 % blaster i BM og PB, <30 % blaster + promyelocytter i BM og PB, <20 % basofilocytter i 
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
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 
Daunorubicin 45 mg/ m2 i.v., days 6-7, 13-14
: 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. 
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
Målorganerne for neoplastiske ændringer var nyrerne, urinblæren, urinrøret, fedtkirtlerne på forhuden og klitoris, tyndtarmen, bisskjoldbruskkirtlerne, binyrererne og den ikkekirtellignende del af maven. 
urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
DEX (6 mg/m2/dag p.o.): dag 1-5; 29-33 6-MP (75 mg/m2/dag, p.o.): dag 8-28 
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
DEX (6 mg/m2/dag,p.o. 
Prednisolone 60 mg/ m2/day oral
(1 time), dag 1-3; vinkistin 1,3 mg/m2 i.v., dag 1, 8, 15, 21; prednisolon 60 mg/m2/dag oral 
Vincristine 1.3 mg/ m2 i.v., days 1, 8, 15, 21;
400 mg som skal tages som 4 tabletter à 100 mg eller én tablet af 400 mg én gang daglig. 
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.
Perikardit*, hjertetamponade* 
Pericarditis*, cardiac tamponade* Vascular disorders4
der hedder granulocyt-koloni-stimulerende faktor (F-CSF). 
granulocyte-colony-stimulating factor (G-CSF).
Hvad forventedes Efgratin anvendt til? 
What was Efgratin expected to be used for?
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. 
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.
Efgratin blev udviklet som et "biosimilært" lægemiddel. 
Efgratin was developed as a ‘biosimilar' medicine.
En yderligere undersøgelse af patienter, der fik kræftmedicin, sammenlignede sikkerheden ved og virkningen af Efgratin og Neulasta. 
A further study in patients receiving cancer medicines compared the safety and effectiveness of Efgratin and Neulasta.
Hvad er Efgratin? 
What is Efgratin?
Efgratin er et lægemiddel, der indeholder det aktive stof pegfilgrastim, som stimulerer dannelsen af neutrofiler (en type hvide blodlegemer, der bekæmper infektioner). 
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).
Det aktive stof i Efgratin, pegfilgrastim, består af filgrastim, der er blevet pegyleret, dvs. forbundet til et kemisk stof, der hedder polyethylenglykol. 
The active substance in Efgratin, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
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. 
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.
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. 
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.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Efgratin? 
What consequences does this withdrawal have for patients in clinical trials?
CHMP var betænkelig ved, at resultaterne af undersøgelserne ikke havde vist, at Efgratin blev håndteret på samme vis i kroppen som referencelægemidlet Neulasta. 
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.
Hvordan virker Efgratin? 
How does Efgratin work?
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"). 
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.
Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde påvist, at Efgratin i høj grad svarer til referencelægemidlet Neulasta. 
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.
Efgratin anvendes til at nedsætte varigheden af neutropeni og forekomsten af neutropeni med feber. 
Efgratin was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Efgratin med særlig udleveringstilladelse. 
The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Efgratin.
Efgratin skulles anvendes til behandling af neutropeni (lavt antal neutrofiler) hos kræftpatienter. 
Efgratin was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).