natgillin/translations-raw huggingface dataset:
- The other ingredients are microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate and anhydrous colloidal silica.The tablet coating is made of hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, iron oxide yellow (E172) and iron oxide red (E172).
Oblogo tablete sestavljajo hipromeloza 6 cps (E464), smukec (E553b), polietilenglikol, rumeni železov oksid (E172) in rdeči železov oksid (E172).
Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Učinkovine, katerih plazemske koncentracije lahko imatinib spremeni Imatinib povečuje povprečno Cmax in AUC simvastatina (substrat CYP3A4) 2-krat oziroma 3,5-krat, kar kaže na to, da imatinib zavira CYP3A4.
(24 h), days 1, 15; 6-MP 25 mg/ m2 oral, days 1-20
(24 ur), 1., 15. dan; 6-MP 25 mg/m2 peroralno, 1.-20. dan konsolidacijska terapija II, IV
(3h), days1-4; Mitoxantrone 10 mg/m2 i.v.
(3 ure), 1.-4. dan; mitoksantron 10 mg/m2 i.v.
DEX 10 mg/ m2 oral, days 1-5;
DEX 10 mg/m2 peroralno, 1.-5. dan;
Very common (may affect more than 1 in 10 people)
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and
Če bolnik odmerek dobro prenaša, ga je mogoče v primeru nezadostnega učinka povečati (glejte poglavji 4.4 in 5.2).
Organ function impairment
Motnje v delovanju organov
6 doses)iii: days 2, 3, 16, and 17
ali peroralno vsakih 6 ur x 6 odmerkov) iii: 2., 3., 16. in 17. dan trojno i.t.
ANC < 1.0x109/l and/or platelets < 50 x 109/l
ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l
The recommended dosage of Imatinib Accord is 600 mg/day for adult patients in accelerated phase.
Priporočeno odmerjanje zdravila Imatinib Accord za odrasle bolnike v pospešeni fazi je 600 mg/dan.
Additionally Imatinib Accord 400 mg tablets are available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1or 90x1 film-coated tablets.
Imatinib Accord 400 mg tablete so na voljo tudi v perforiranem pretisnem omotu za enkratni odmerek (PVC/ PVdC/aluminij) v pakiranjih po 30 x 1, 60 x 1, 90 x 1 filmsko obložena tableta.
(3 h, q 12 h), days 1-3; Vincristine 2 mg i.v., days 4, 11;
(3 ure, na 12 ur), 1.-3. dan; vinkristin 2 mg i.v., 4., 11. dan; doksorubicin 50 mg/m2 i.v.
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.
Če se pojav/a ANC  1,0 x 109/l in/ali koncentracija trombocitov  50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z zdravilom Imatinib Accord z zmanjšanim odmerkom 260 mg/m2.
In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).When needed,discontinuation of Imatinib treatment may be considered.
Poleg tega so v okviru izkušenj v obdobju trženja zdravila pri bolnikih s KML, ALL in drugimi boleznimi poročali o žilnih ektazijah antruma želodca (GAVE - gastric antral vascular ectasia), redkem vzroku gastrointestinalne krvavitve (glejte poglavje 4.8).
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
- z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph pozitivna ALL).
Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
9/l, trombociti < 450 x 109/l, mielociti+metamielociti < 5 % v krvi, brez blastov in promielocitov v krvi, bazofilci < 20 %, brez ekstramedularne prizadetosti Kriteriji citogenetičnega odziva: popolni (0 % Ph+ metafaz), delni (1-35 %), manjši (36-65 %) ali minimalni (66-95 %).
In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4% and 0.7% of patients, respectively, and may have been related to gastrointestinal or intra-tumoural bleeding in at least some of these patients.
V študiji pri bolnikih z neresektabilnimi in/ali metastatskimi GIST so poročali o anemiji 3. in 4. stopnje pri 5,4 % oziroma 0,7 % bolnikov.
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 400 mg filmsko obložene tablete so rjavooranžne, ovalne, bikonveksne filmsko obložene tablete z vtisnjenima oznakama “IM” in “T2” na vsaki strani zareze na eni strani tablete in brez oznake na drugi strani.
PVC/PVdC/Alu blisters
POSEBNA NAVODILA ZA SHRANJEVANJE Za pretisne omote iz PVC/PVdC/aluminija
(24 h), day 1, and Ara-C 2 g/ m2 i.v.
(24 ur), 1.dan in Ara-C 2 g/m2 i.v.
Posology for MDS/MPD
- Če se zdravite zaradi MDS/MPD
Maintenance (8-week cycles) Cycles 1cy
): 44. dan vzdrževalno zdravljenje (8-tedenski ciklusi) 1.-4. ciklus
The recommended dose of Imatinib Accord is 400 mg/day for adult patients with MDS/MPD.
Odmerjanje pri MDS/MPD Priporočeni odmerek zdravila Imatinib Accord pri odraslih bolnikih z MDS/MPD je 400 mg/dan.
Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg imatinib (as mesilate).
- Ena 400 mg filmsko obložena tableta zdravila Imatinib Accord vsebuje 400 mg imatiniba (v obliki mesilata).
The recommended dosage of Imatib Accord is 400 mg/day for adult patients in chronic phase CML.
Priporočeno odmerjanje zdravila Imatinib Accord za odrasle bolnike v kronični fazi KML je
Stop Imatinib Accord until ANC ≥ 1.5x109/1 and platelets ≥ 75x109/1.
Prekinite zdravljenje z zdravilom Imatinib Accord dokler ni ANC  1,5 x 109/l in koncentracija trombocitov  75 x 109/l.
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children and adolescents in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
pride v poštev pri otrocih in mladostnikih, ki nimajo hudih neželenih učinkov na zdravilo in hude nevtropenije ali trombocitopenije, ki ni povezana z levkemijo, in sicer v sledečih okoliščinah: napredovanje bolezni (kadarkoli); odsotnost zadovoljivega hematološkega odziva po najmanj 3 mesecih zdravljenja; odsotnost citogenetičnega odziva po 12 mesecih zdravljenja; ali izguba že prej doseženega hematološkega ali citogenetičnega odziva ali obojega.
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• občutek slabosti s siljenjem na bruhanje (navzea) z drisko, in bruhanjem, bolečine v trebuhu ali povišana telesna temperatura (znaki težav s črevesjem),
Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
9 V obdobju trženja zdravila so opažali mišično-skeletne bolečine med zdravljenjem z imatinibom ali po prekinitvi zdravljenja.
days3-5;
3.-5. dan;
You may become more sensitive to the sun while taking Imatinib Accord.
Med jemanjem zdravila Imatinib Accord lahko postanete občutljivejši na sonce.
However, always take this medicine exactly as your doctor or pharmacist has told you.
Seveda pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
MTX 15 mg intrathecal, days 1, 8, 15, 22;
MTX 15 mg intratekalno,1., 8., 15., 22. dan; Ara-C 40 mg intratekalno, 1., 8., 15., 22. dan;
MTX 15 mg intrathecal, day1;
MTX 15 mg intratekalno, 1. dan indukcijsko zdravljenje I
The recommended dose of Imatinib is 800 mg/day for adult patients with DFSP.
Odmerjanje pri DFSP Priporočeni odmerek zdravila Imatinib pri odraslih bolnikih z DFSP je 800 mg/dan.
Table 1 Tabulated summary of adverse reactions Infections and infestations Uncommon
Preglednica 1 Preglednica neželenih učinkov
How to store Imatinib Accord
Shranjevanje zdravila Imatinib Accord
Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets imatinib
Imatinib Accord 100 mg filmsko obložene tablete Imatinib Accord 400 mg filmsko obložene tablete imatinib
An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Pri bolnikih z mieloproliferativnimi neoplazmami s preureditvijo PDGFR-β, ki so se zdravili z zdravilom imatiniba, je bila izvedena opazovalna študija (študija L2401) in sicer uvedba registra za dolgoročno zbiranje podatkov o varnosti in učinkovitosti.
aANC < 0.5x109/1 and/or platelets < 10 x 109/1
aANC < 0,5 x 109/l in/ali koncentracija trombocitov < 10 x 109/l
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
pogosti flatulenca, napihnjen trebuh, gastroezofagealni refluks, obstipacija, suha usta, gastritis občasni stomatitis, razjede ustne sluznice, krvavitev iz prebavil7, spahovanje, melena, ezofagitis, ascites, želodčna razjeda, hematemeza, vnetje ustnice, disfagija, pankreatitis redki kolitis, ileus, vnetna bolezen črevesa pogostnost neznana ileus/zapora črevesja*, gastrointestinalna perforacija*, divertikulitis*, žilne ektazije antruma želodca (GAVE)*
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.
Izgled zdravila Imatinib Accord in vsebina pakiranja Imatinib Accord 100 mg filmsko obložene tablete so rjavooranžne, okrogle, bikonveksne filmsko obložene tablete z vtisnjenima oznakama “IM” in “T1” na vsaki strani zareze na eni strani tablete in brez oznake na drugi strani
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.
Če se pojav/a ANC  1,0 x 109/l in/ali koncentracija trombocitov  50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z zdravilom Imatinib Accord z zmanjšanim odmerkom 300 mg.
Consolidation therapy DEX 10 mg/ m2oral, days 1-5; Vindesine 3 mg/ m2 i.v., day 1;
DEX 10 mg/m2 peroralno, 1.-5. dan; vindezin 3 mg/m2 i.v., 1. dan;
Polyethylene glycol Iron oxide yellow (E172) Iron oxide red (E172)
Obloga tablete hipromeloza 6 cps (E464) smukec (E553b) polietilenglikol rumeni železov oksid (E172) rdeči železov oksid (E172)
You may feel dizzy or drowsy or get blurred vision while taking this medicine.
Vpliv na sposobnost upravljanja vozil in strojev V času jemanja tega zdravila lahko postanete omotični ali zaspani ali se vam zamegli vid.
VCR (1.5 mg/m2/day, IV): days 1, 8, and 15 DAUN (45 mg/m2/day bolus, IV): days 1 and 2
): 1., 8. in 15. dan DAUN (45 mg/m2/dan bolus, i.v.
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3publications.
V 3 publikacijah so objavljeni podatki treh (3) bolnikov s HES oziroma CEL s preureditvijo gena za PDGFR.
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
in 3. dan G-CSF (5 μg/kg, s.c.): 4.-13. dan oziroma do ANC > 1500 po doseženem najnižjem številu
For PVC/PVdC/Alu blisters Do not store above 30C.
Pretisni omoti iz PVC/PVdC/aluminija Shranjujte pri temperaturi do 30 C.
urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Tarčni organi za neoplastične spremembe so bili: ledvice, sečni mehur, sečnica, žleze prepucija in klitorisa, tanko črevo, obščitnične žleze, nadledvične žleze in ne-žlezni del želodca.
Imatinib Accord 100 mg film-coated tablets
Imatinib Accord 100 mg filmsko obložene tablete
• Muscle cramps or joint, muscle or bone pain, during Imatinib Accord treatment or after you have stopped taking Imatinib Accord.
• mišični krči ali bolečine v sklepih, mišicah ali kosteh v obdobju, ko se zdravite z zdravilom
The recommended dose of Imatinib Accord is 100 mg/day for adult patients with HES/CEL.
Odmerjanje pri HES/CEL Priporočeni odmerek zdravila Imatinib Accord pri odraslih bolnikih s HES/CEL je 100 mg/dan.
Each 100 mg film-coated tablet of Imatinib Accorcd ontains 100 mg imatinib (as mesilate).
- Ena 100 mg filmsko obložena tableta zdravila Imatinib Accord vsebuje 100 mg imatiniba (v obliki mesilata).
Newly diagnosed Ph+ ALL
Novo odkrita Ph+ ALL
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.
Rjavooranžne, okrogle, bikonveksne filmsko obložene tablete z vtisnjenima oznakama “IM” in “T1” na vsaki strani zareze na eni strani tablete in brez oznake na drugi strani.
During treatment with Imatinib Accord, tell your doctor straight away if you put on weight very quickly.
Če med jemanjem zdravila Imatinib Accord začnete hitro pridobivati telesno maso, takoj obvestite zdravnika.
The recommended dose of Imatinib is 600 mg/day for adult patients in blast crisis.
Priporočeni odmerek zdravila Imatinib Accord za odrasle bolnike v blastni krizi je 600 mg/dan.
Imatinib Accord 400 mg film-coated tablets
Imatinib Accord 400 mg filmsko obložene tablete
If any of these affects you severely, tell your doctor.
Če imate hudo obliko katerega od zgoraj navedenih učinkov, obvestite zdravnika.
NAME OF MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets
Imatinib Accord 100 mg filmsko obložene tablete Imatinib Accord 400 mg filmsko obložene tablete
• Painful and/or blistering skin lesions.
• boleče spremembe na koži z ali brez nastanka mehurjev.
Severe elevation of transaminases (< 5%) or bilirubin (< 1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Navadno so to urejali z zmanjšanjem odmerka ali s prekinitvijo zdravljenja (povprečno trajanje teh epizod je bilo približno en teden).
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
9/l, mielociti+metamielociti < 5 % v krvi, brez blastov in promielocitov v krvi, bazofilci < 20 %, brez prizadetosti zunaj kostnega mozga] in v študijah 0102 in 0109 [ANC 1,5 x 10
Total bilirubin: > 3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
IULN = zgornja meja normalnih vrednosti, specifična za ustanovo
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.
Rjavooranžne, ovalne, bikonveksne filmsko obložene tablete z vtisnjenima oznakama “IM” in “T2” na vsaki strani zareze na eni strani tablete in brez oznake na drugi strani.
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
ARA-C (3 g/m2, vsakih 12 ur, i.v.
Daunorubicin 45 mg/ m2 i.v., days 6-7, 13-14
VCR 2 mg i.v., 6., 13., 20. dan; daunorubicin 45 mg/m2 i.v., 6.-7., 13.-14. dan indukcijsko zdravljenje II
G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
): 22.-26. dan G-CSF (5 μg/kg, s.c.): 27.-36. dan oziroma do ANC > 1500 po doseženem najnižjem številu
Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
hipotenzija, Raynaudov fenomen pogostnost neznana tromboza/embolija* Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja, krvavitev iz nosu, kašelj občasni plevralni izliv5, bolečine v žrelu in grlu, vnetje žrela redki plevritična bolečina, pljučna fibroza, pljučna hipertenzija, pljučna krvavitev pogostnost neznana akutna respiratorna odpoved11*, intersticijska pljučna bolezen* Bolezni prebavil zelo pogosti navzea, driska, bruhanje, dispepsija, bolečine v trebuhu6
You should take
• izpuščaj,
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Podatki kažejo, da so lahko citopenije pogostejše pri velikih odmerkih  750 mg (študija prve faze),
When and how to take Imatinib Accord
Kdaj in kako jemati zdravilo Imatinib Accord - Zdravilo Imatinib Accord vzemite z obrokom hrane.
Manufacturer
ZDRAVILA
Common (may affect up to 1 in 10 people)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
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.
Začetni odmerek je 400 mg, kar vzamete kot 4 tablete po 100 mg ali eno tableto po 400 mg enkrat na dan.
DEX 10 mg/ m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3-5; MTX 15mg intrathecal, day 1
DEX 10 mg/m2 peroralno, 1.-5. dan; CP 200 mg/m2 i.v., 3.-5. dan;
Partial Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): CHR: Study 0110 [WBC < 10 x 109/l, platelets < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
RTC < 15 % blastov v BM in PB, < 30 % blastov+promielocitov v BM in PB, < 20 % bazofilcev v PB, brez bolezni zunaj kostnega mozga, razen v vranici in jetrih (samo za 0102 in 0109).
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
): 1. in 15. dan levkovorin (75 mg/m2 36 ur po začetku, i.v.
NAME OF THE MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets imatinib
Imatinib Accord 100 mg filmsko obložene tablete imatinib
Increased intracranial pressure, convulsions, optic neuritis
Prilagajanje odmerkov zaradi nevtropenije in trombocitopenije:
If your daily dose is 800 mg (8 tablets of 100 mg or 2 tablets of 400 mg).
Če je vaš dnevni odmerek 800 mg (8 tablet po 100 mg ali 2 tableti po 400 mg), morate vzeti 4 tablete po 100 mg ali 1 tableto po 400 mg zjutraj in 4 tablete po 100 mg ali 1 tableto po 400 mg zvečer.
Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50
): 1. in 29. dan DEX (6 mg/m2/dan, peroralno): 1.-5. dan in 29.-33. dan 6-MP (75 mg/m2/dan, peroralno): 1.-56. dan metotreksat (20 mg/m2/teden, peroralno): 1., 8., 15., 22., 29., 36., 43. in 50. dan
DAUN (45 mg/m2/day bolus, IV): days 1 and 2
):1., 8. in 15. dan DAUN (45 mg/m2/dan bolus, i.v.
Clinical studies in chronic myeloid leukaemia
Preglednica 3 Odziv pri odraslih bolnikih s KML v kliničnih študijah
Muscular weakness, arthritis, rhabdomyolysis/myopathy
Taka zdravila so karbamazepin, okskarbazepin in fenitoin.
Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
prednizolon 200 mg peroralno, 5 dni na mesec v obdobju 13 mesecev
NAME OF THE MEDICINAL PRODUCT Imatinib Accord 400 mg film-coated tablets imatinib
Imatinib Accord 400 mg filmsko obložene tablete imatinib
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg imatinib (as mesilate)
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 doses)iii: Days 2 and 3
zdravljenje (prilagojeno na starost): 1. dan ARA-C (3 g/m2/odmerek vsakih 12 ur x 4, i.v.):2.
Haematological response criteria (all responses to be confirmed after ≥ 4 weeks):
1 Kriteriji hematološkega odziva (vsi odzivi morajo biti potrjeni po 4 tednih): CHR študija 0110 [WBC < 10 x 10
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.
Družba Gedeon Richter Plc je 16. novembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Efgratin, namenjenim zmanjševanju nevtropenije.
Withdrawal of the marketing authorisation application for Efgratin (pegfilgrastim) EMA/822770/2016
Umik vloge za pridobitev dovoljenja za promet z zdravilom Efgratin (pegfilgrastim) EMA/822770/2016
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.
To pomeni, da naj bi bilo zelo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji, in sicer zdravilu Neulasta.
A further study in patients receiving cancer medicines compared the safety and effectiveness of Efgratin and Neulasta.
V drugi študiji pri bolnikih, ki so prejemali zdravila za zdravljenje raka, so primerjali varnost in učinkovitost zdravil Efgratin in Neulasta.
The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Efgratin.
Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe zdravila Efgratin.
Withdrawal of the marketing authorisation application for Efgratin (pegfilgrastim)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Efgratin (pegfilgrastim)
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.
Družba je predstavila rezultate študij pri zdravih ljudeh, ki naj bi pokazale, da je zdravilo Efgratin po kemijski strukturi, čistosti, načinu delovanja in tem, kako ga telo presnavlja, zelo podobno referenčnemu zdravilu Neulasta.
Efgratin was developed as a ‘biosimilar' medicine.
Zdravilo Efgratin je bilo razvito kot „podobno biološko zdravilo“.
The active substance in Efgratin, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Zdravilna učinkovina v zdravilu Efgratin, pegfilgrastim, je sestavljena iz filgrastima, ki je bil pegiliran (nanj je bila pritrjena kemična snov, imenovana polietilenglikol).
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).
Efgratin je zdravilo, ki vsebuje zdravilno učinkovino pegfilgrastim, ki spodbuja nastajanje nevtrofilcev (vrste belih krvnih celic, ki se borijo proti okužbam).
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.
Zato je odbor CHMP ob umiku vloge menil, da družba ni dokazala, da je zdravilo Efgratin zelo podobno zdravilu Neulasta.
What was Efgratin expected to be used for?
Za kaj naj bi se zdravilo Efgratin uporabljalo?
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.
Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Efgratin ni mogoče odobriti za zmanjševanje nevtropenije.
Efgratin was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Zdravilo Efgratin naj bi se uporabljajo pri rakavih bolnikih za zmanjševanje nevtropenije (nizkih ravni nevtrofilcev).
How does Efgratin work?
Kako zdravilo Efgratin deluje?