FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg imatinib (as mesilate).
Croatian: Jedna filmom obložena tableta Imatinib Accorda od 400 mg sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: How to store Imatinib Accord
Croatian: Kako čuvati Imatinib Accord
English: Cytogenetic response
Croatian: Veliki citogenetski odgovor2
English: Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Croatian: Veliki odgovor je kombinacija potpunih i djelomičnih odgovora: potpuni (0% Ph+ metafaza), djelomični (1-35%)
English: Thrombosis/embolism*
Croatian: Nepoznato Tromboza/embolija
English: Each 100 mg film-coated tablet of Imatinib Accorcd ontains 100 mg imatinib (as mesilate).
Croatian: Jedna filmom obložena tableta Imatinib Accorda od 100 mg sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Croatian: Manje često Trombocitemija, limfopenija, depresija koštane srži, eozinofilija, limfadenopatija Rijetko
English: Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets imatinib
Croatian: Imatinib Accord 100 mg filmom obložene tablete Imatinib Accord 400 mg filmom obložene tablete imatinib
English: MTX 1.5 g/ m2 i.v.
Croatian: MTX 1,5 g/m2 i.v. (24 h), dan 1;
English: (3h), days1-4; Mitoxantrone 10 mg/m2 i.v.
Croatian: Ara-C 1000 mg/m2/12 h i.v.(3 h), dani 1-4; Mitoksantron 10 mg/m2 i.v. dani 3-5;
English: The recommended dose of Imatinib Accord is 400 mg/day for adult patients with MDS/MPD.
Croatian: Za odrasle bolesnike s MDS/MPD-om preporučena doza Imatinib Accorda iznosi 400 mg/dan.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.
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.
Croatian: Pored toga, Imatinib Accord 100 mg tablete također su dostupne u PVC/PVdC/Alu perforiranom blisteru s jediničnim dozama u veličinama pakiranja od 30x1, 60x1, 90x1, 120x1 ili 180x1 filmom obložena tableta.
English: MTX 15 mg intrathecal, day1;
Croatian: MTX 15 mg intratekalno, dan 1;
English: Very common Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6 Common
Croatian: Mučnina, proljev, povraćanje, dispepsija, bol u trbuhu6
English: The recommended dosage of Imatinib Accord is 600 mg/day for adult patients in accelerated phase.
Croatian: Za odrasle bolesnike u ubrzanoj fazi preporučena doza Imatinib Accorda iznosi 600 mg/dan.
English: - if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Accord, contact your doctor.
Croatian: Prije početka liječenja liječnik će pažljvo pregledati bolesnike radi utvrđivanja eventualnih znakova te infekcije. - ako dobijete modrice, krvarenje, vrućicu, umor i smetenost prilikom uzimanja Imatinib Accorda, kontaktirajte liječnika.
English: Investigations
Croatian: dijagnoze
English: (1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/ m2 oral, days 26-46
Croatian: Indukcijska terapija II CP 1 g/m2 i.v. (1 h), dani 26, 46; Ara-C 75 mg/m2 i.v. (1 h), dani 28-31, 35-38, 42-45; 6-MP 60 mg/m2peroralno, dani 26-46
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.
Croatian: Pored toga, Imatinib Accord 400 mg tablete dostupne su u PVC/PVdC/Alu perforiranom blisteru s jediničnim dozama u veličinama pakiranja od 30x1, 60x1 ili 90x1 filmom obložena tableta.
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.
Croatian: U slučaju da je ABN ponovno < 1,0 x 109/l i/ili trombociti < 50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu Imatinib Accorda u smanjenoj dozi od 400 mg.
English: Additionally Imatinib Accord 100 mg tablets are also available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.
Croatian: Pored toga, Imatinib Accord 100 mg tablete također su dostupne u perforiranom blisteru s jediničnim dozama (PVC/PVdC/Alu) u veličinama pakiranja od 30x1, 60x1, 90x1, 120x1 ili 180x1 filmom obložena tableta.
English: VCR (1.5 mg/m2/day, IV): days 1, 29
Croatian: VCR (1,5 mg/m2/dan, i.v.): dani 1, 8, i 15
English: (1 h), days 1-5; VM26 60 mg/ m2 i.v.
Croatian: Ara-C 75 mg/m2 i.v. (1 h), dani 1-5; VM26 60 mg/m2 i.v. (1 h), dani 1-5
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: Tablica 1 Tablični sažetak nuspojava
English: Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Croatian: Metilprednizolon 40 mg intratekalno, dani 1, 8, 15, 22
English: Imatinib Accord 100 mg film-coated tablets
Croatian: Imatinib Accord 100 mg filmom obložene tablete
English: Additionally Imatinib Accord 400 mg tablets are available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1or 90x1 film-coated tablets.
Croatian: Pored toga, Imatinib Accord 400 mg tablete dostupne su u perforiranom blisteru s jediničnim dozama (PVC/PVdC/Alu) u veličinama pakiranja od 30x1, 60x1 ili 90x1 filmom obložena tableta.
English: Imatinib Accord 400 mg film-coated tablets
Croatian: Imatinib Accord 400 mg filmom obložene tablete
English: Moderate
Croatian: Umjereni
English: Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
Croatian: 9 Nakon stavljanja lijeka u promet primijećena je mišićno-koštana bol koja se javlja tijekom liječenja imatinibom, kao i nakon prekida liječenja.
English: Doxorubicine 50 mg/ m2 i.v.
Croatian: Doksorubicin 50 mg/m2 i.v. (24 h), dan 4;
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/001-004
Croatian: Imatinib Accord 100 mg tablete EU/1/13/845/001-004
English: The recommended dose of Imatinib is 600 mg/day for adult patients in blast crisis.
Croatian: Za odrasle bolesnike u blastičnoj krizi preporučena doza imatinibaiznosi 600 mg/dan.
English: If your daily dose is 800 mg (8 tablets of 100 mg or 2 tablets of 400 mg).
Croatian: Ako Vaša dnevna doza iznosi 800 mg (8 tableta od 100 mg ili 2 tablete od 400 mg), trebate uzimati 4 tablete od 100 mg ili 1 tabletu od 400 mg ujutro i 4 tablete od 100 mg ili 1 tabletu od 400 mg navečer.
English: (24 h), days 1, 15; 6-MP 25 mg/ m2 oral, days 1-20
Croatian: MTX 500 mg/m2 i.v. (24 h), dani 1, 15; 6-MP 25 mg/m2peroralno, dani 1-20
English: urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Croatian: Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra, žlijezda prepucija i klitorisa, tanko crijevo, paratireoidne žlijezde, nadbubrežne žlijezde i nežljezdani dio želuca.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/009-011
Croatian: Imatinib Accord 400 mg tablete EU/1/13/845/009-011
English: Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Croatian: Manje često Hipertenzija, hematom, subduralni hematom, periferna hladnoća, hipotenzija,
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/ m2 i.v.
Croatian: DEX 40 mg/danna dane 1-4 i 11-14, izmjenjivano sMTX 1 g/m2 i.v. (24 h), dan 1, Ara-C 1 g/m2 i.v. (2 h, svakih 12 h), dani 2-3 (ukupno 8 ciklusa)
English: Use in adults
Croatian: Primjena uodraslih osoba
English: Induction therapy II
Croatian: Konsolidacijska terapija 2
English: NAME OF MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets
Croatian: Imatinib Accord 100 mg filmom obložene tablete Imatinib Accord 400 mg filmom obložene tablete
English: BM = bone marrow, PB = peripheral blood Cytogenetic response criteria: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%) 3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Croatian: * p<0,001, Fischerov egzaktni test ** postotci molekularnog odgovora se temelje na dostupnim uzorcima Kriteriji hematološkog odgovora (svi se odgovori moraju potvrditi nakon ≥4 tjedna): WBC <10 x 109/l, trombociti < 450 x 109/l, mijelociti+metamijelociti <5% u krvi, nema blasta i promijelocita u krvi, bazofili < 20%, nema ekstramedularne zahvaćenosti Kriteriji citogenetskog odgovora: potpun (0% Ph+ metafaza), djelomičan (1-35%), manji (36-65%) ili minimalan (66-95%).
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets of 100 mg or one tablet of 400 mg once a day, depending on how you respond to treatment.
Croatian: Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, a uzimaju se 4 tablete od 100 mg ili jedna tableta od 400 mg jednom dnevno.
English: SPECIAL STORAGE CONDITIONS For PVC/PVdC/Alu blisters Do not store above 30C.
Croatian: POSEBNE MJERE ČUVANJA Za PVC/PVdC/Alu blistere
English: CP 1 g/ m2 i.v.
Croatian: CP 500 mg/m2 i.v.(1 h) dan 1;
English: Tumour haemorrhage/tumour necrosis* Immune system disorders Not known
Croatian: Nepoznato Tumorsko krvarenje/tumorska nekroza* Poremećaji imunološkog sustava Nepoznato Anafilaktički šok* Poremećaji krvi i limfnog sustava Vrlo često
English: The recommended dose of Imatinib Accord is 100 mg/day for adult patients with HES/CEL.
Croatian: Za odrasle bolesnike s HES/KEL-om preporučena doza Imatinib Accorda iznosi 100 mg/dan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg imatinib (as mesilate)
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
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.
Croatian: Smećkastonarančaste, okrugle, bikonveksne filmom obložene tablete s utisnutom oznakom „IM“ na jednoj strani razdjelne crte i „T1“ na drugoj strani razdjelne crte te bez oznaka na drugoj strani tablete.
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the
Croatian: 6-MP (75 mg/m2/dan, p.o.): dani 11-56 (Uskratiti 6-MP tijekom 6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1-og dana nakon završetka kranijalne iradijacije.)
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.
Croatian: Početna doza je 600 mg, koja se uzima kao 6 tableta od 100 mg ili kao jedna tableta od 400 mg te 2 tablete od 100 mg jednom na dan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg imatinib (as mesilate)
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: Etoposide 250 mg/ m2 i.v.
Croatian: Etopozid 250 mg/m2 i.v. (1 h) dani 4-5;
English: Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Croatian: Prednizon 60 mg/m2peroralno, dani 1-7, 15-21;
English: VCR 2 mg i.v., days 6, 13, 20;
Croatian: I DEX 10 mg/m2peroralno, dani 1-5; VCR 2 mg i.v., dani 6, 13, 20;
English: • Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
Croatian: • teška glavobolja, slabost ili oduzetostudova ili lica, otežan govor, iznenadni gubitak svijesti
English: aANC < 0.5x109/1 and/or platelets < 10 x 109/1
Croatian: aABN <0,5 x 109/l i/ili trombociti <10 x 109/l
English: Consolidation therapy DEX 10 mg/ m2oral, days 1-5; Vindesine 3 mg/ m2 i.v., day 1;
Croatian: DEX 10 mg/m2peroralno, dani 1-5; CP 200 mg/m2 i.v., dani 3-5;
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.
Croatian: Smećkastonarančaste, ovalne, bikonveksne filmom obložene tablete s utisnutom oznakom „IM“ na jednoj strani razdjelne crte i „T2“ na drugoj strani razdjelne crte te bez oznaka na drugoj strani tablete.
English: • Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
Croatian: • mučnina, povraćanje, proljev ili probavne smetnje.
English: Imatinib Accord is indicated for the treatment of
Croatian: Accord je indiciran za liječenje
English: Pericarditis*, cardiac tamponade* Vascular disorders4
Croatian: Periorbitalni edem, dermatitis/ekcem/osip
English: 3) [95% CI]
Croatian: Potpuni (Potvrđeni3) [95% CI]
English: Common
Croatian: Djelomični
English: Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.
Croatian: Za odrasle bolesnike s Ph+ ALL-om preporučena doza imatiniba iznosi 600 mg/dan.Specijalisti hematolozi uključeni u liječenje ove bolesti trebaju nadzirati terapiju kroz sve faze liječenja.
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.
Croatian: Osim toga, djeca i adolescenti liječeni su u dva ispitivanja faze I i jednom ispitivanju faze II.
English: NAME OF THE MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets imatinib
Croatian: Imatinib Accord 100 mg filmom obložene tablete imatinib
English: NAME OF THE MEDICINAL PRODUCT Imatinib Accord 400 mg film-coated tablets imatinib
Croatian: Imatinib Accord 400 mg filmom obložene tablete imatinib
English: • For PVC/PVdC/Alu blisters Do not store above 30C.
Croatian: • Za PVC/PVdC/Alu blistere
English: (3 h, q 12 h), days 1-3; Vincristine 2 mg i.v., days 4, 11;
Croatian: Hiper-CVAD režim: CP 300 mg/m2 i.v. (3 h, svakih 12 h), dani 1-3; Vinkristin 2 mg i.v., dani 4, 11;
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.
Croatian: Početna doza je 400 mg, koja se uzima kao 4 tablete od 100 mg ili 1 tableta od 400 mg jednom na dan.
English: Daunorubicin 60 mg/ m2 i.v.
Croatian: Vindezin 3 mg/m2 i.v., dan 1;
English: Inductionconsolidation therapy
Croatian: Studija AUS01 Indukcijskokonsolidacijska terapija
English: Molecular response**
Croatian: gastrična antralna vaskularna ektazija (GAVE)*
English: The recommended dosage of Imatib Accord is 400 mg/day for adult patients in chronic phase CML.
Croatian: Za odrasle bolesnike u kroničnoj fazi KML-a preporučena doza Imatinib Accorda iznosi 400 mg/dan.
English: Vertigo, tinnitus, hearing loss
Croatian: Manje često Vrtoglavica, tinitus, gubitak sluha Srčani poremećaji
English: • Stomach pain with feeling sick (nausea).
Croatian: • bol u trbuhu s mučninom.
English: Ara-C 2x 2 g/ m2 i.v.
Croatian: Ara-C 2x 2 g/m2 i.v. (3 h, svakih 12 h), dan 5
English: Elderly
Croatian: sepsa
English: MTX 12 mg intrathecal, day 1 Remission induction DEX 10 mg/ m2 oral, days 6-7, 13-16;
Croatian: Indukcija remisije DEX 10 mg/m2peroralno, dani 6-7, 13-16; VCR 1 mg i.v., dani 7, 14;
English: 16 December 2016 EMA/822770/2016 EMEA/H/C/004023
Croatian: EMA/822770/2016 EMEA/H/C/004023
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.
Croatian: Dana 16. studenoga 2016., tvrtka Gedeon Richter Plc službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Efgratin za smanjenje neutropenije.
English: What is Efgratin?
Croatian: Što je 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.
Croatian: To znači da je Efgratin trebao biti vrlo sličan biološkom lijeku („referentnom lijeku”) koji je već odobren u Europskoj uniji (EU) pod nazivom Neulasta.
English: Efgratin was developed as a ‘biosimilar' medicine.
Croatian: Efgratin je razvijen kao biosličan lijek.
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.
Croatian: Tvrtka je predočila rezultate ispitivanja u zdravih ljudi koja su provedena kako bi se dokazalo da je Efgratin vrlo sličan svojem referentnom lijeku Neulasta u smislu kemijske strukture, čistoće, načina djelovanja i načina na koji tijelo podnosi lijek.
English: A further study in patients receiving cancer medicines compared the safety and effectiveness of Efgratin and Neulasta.
Croatian: U dodatnom ispitivanju, koje je uključivalo bolesnike koji su dobivali lijekove za liječenje raka, provedena je usporedba sigurnosti i učinkovitosti lijekova Efgratin i Neulasta.
English: What was Efgratin expected to be used for?
Croatian: Za što se Efgratin trebao koristiti?
English: Withdrawal of the marketing authorisation application for Efgratin (pegfilgrastim)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Efgratin (pegfilgrastim)
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments because the treatments also kill white blood cells.
Croatian: Neutropenija je nuspojava određenih citotoksičnih (ubijanje stanica) načina liječenja raka jer se takvim liječenjem ubijaju i bijele krvne stanice.
English: How does Efgratin work?
Croatian: Kako djeluje Efgratin?
English: The active substance in Efgratin, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Croatian: Djelatna tvar u lijeku Efgratin, pegfilgrastim, sastoji se od filgrastima koji je „pegiliran” (spojen s kemijskom tvari koja se naziva polietilen glikol).
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Efgratin.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja ili programa milosrdnog davanja lijeka Efgratin koji su u tijeku.
English: Withdrawal of the marketing authorisation application for Efgratin (pegfilgrastim) EMA/822770/2016
Croatian: (pegfilgrastim) EMA/822770/2016
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).
Croatian: Efgratin je lijek koji sadrži djelatnu tvar pegfilgrastim koja potiče stvaranje neutrofila (vrsta bijelih krvnih stanica koje se bore protiv infekcija).
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.
Croatian: Na temelju pregleda podataka te odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je izrazio svoju zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Efgratin za smanjenje neutropenije.
English: Efgratin was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Croatian: Lijek Efgratin trebao se primjenjivati za smanjenje trajanja neutropenije i pojave febrilne neutropenije (neutropenija praćena vrućicom).
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.
Croatian: CHMP je izrazio zabrinutost zbog toga što rezultati ispitivanja nisu pokazali da tijelo podnosi lijek Efgratin na isti način kao i referentni lijek Neulasta.
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.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao da tvrtka nije dokazala da je lijek Efgratin vrlo sličan lijeku Neulasta.
English: Efgratin was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Croatian: Lijek Efgratin trebao se primjenjivati u bolesnika oboljelih od raka radi smanjenja neutropenije (niske razine neutrofila).
English: Filgrastim is very similar to a human protein called
Croatian: Filgrastim je vrlo sličan ljudskom proteinu koji se naziva faktor stimulacije kolonije granulocita (G-CSF).
English: The full EPAR for Abraxane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Abraxane nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Croatian: "Metastatski" znači da se rak proširio na druge dijelove tijela;
English: The main measure of effectiveness was the number of patients who ‘responded' after at least five weeks of treatment.
Croatian: Osnovna mjera djelotvornosti bio je broj bolesnica koje su "odgovorile na liječenje" nakon barem pet tjedana terapije.
English: A response was defined as the patient's main tumours disappearing or shrinking in size by at least 30%.
Croatian: Taj je odgovor definiran kao nestanak osnovnog tumora bolesnica ili njegovo smanjenje za barem 30%.
English: Abraxane is used to treat the following cancers in adults:
Croatian: Abraxane se koristi za liječenje sljedećih vrsta raka u odraslih:
English: Abraxane is given into a vein over a period of 30 minutes.
Croatian: Abraxane se daje u venu u razdoblju od 30 minuta.
English: Paclitaxel has been available as a cancer medicine since 1993.
Croatian: Paklitaksel se koristi kao lijek protiv raka od 1993.
English: The recommended dose is 125 mg per square metre of body surface area once a day on days 1, 8 and 15 of each cycle.
Croatian: Preporučena doza je 125 mg po kvadratnom metru tjelesne površine jednom na dan, 1., 8. i 15. dana svakog ciklusa.
English: It should not be interchanged with other medicines containing paclitaxel.
Croatian: Ne smije se naizmjence koristiti s drugim lijekovima koji sadrže paklitaksel.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abraxane on 11 January 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Abraxane na snazi u Europskoj uniji od 11. siječnja 2008.
English: The most common important side effects with Abraxane (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cells), gastrointestinal disorders (disorders of the digestive system), peripheral neuropathy (nerve damage including damage to the nerves in the hand and feet), arthralgia (joint pain) and myalgia (muscle pain).
Croatian: Najčešće važne nuspojave lijeka Abraxane (kod više od 1 na 10 bolesnika) bile su neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica), gastrointestinalni poremećaji (poremećaji probavnog sustava), periferna neuropatija (oštećenja živaca, uključujući oštećenja živaca dlanova i stopala), antralgija (bol u zglobovima) i mijalgija (bol u mišićima).
English: The recommended dose is 260 mg per square metre of body surface area (calculated using the patient's height and weight).
Croatian: Preporučena doza iznosi 260 mg po kvadratnom metru tjelesne površine (izračunato temeljem visine i tjelesne težine bolesnika).
English: This document is a summary of the European Public Assessment Report (EPAR) for Abraxane.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Abraxane.