natgillin/translations-raw huggingface dataset:
Reckitt Benckiser Healthcare International Ltd.
Clonmel Healthcare Ltd.
Ibu-Lysin Ratiopharm Ibuprofen lysine 684 mg Coated tablet
Ibuprofen lizin Ibu-Lysin Ratiopharm 684 mg
15562 Rüdersdorf Germany
Maienbergstr. 10-12 15562 Rüdersdorf Germany
Via Licinio 11
Via Ardeatina Km
Ibuprofen phenylephrine hydrochloride
Ibuprofen Fenilefrin hidroklorid
Seractil Dolo 300 mg filmtabletta
Deksibuprofen Seractil Dolo 300 mg filmtabletta
Seractil 300 mgFilmtabletten
Deksibuprofen Seractil 300 mgFilmtabletten
Tadworth, Surrey KT20 7NS
Pfizer Consumer Healthcare Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS United Kingdom
Imbun Zäpfchen Ibuprofen lysine 500 mg Suppository
Ibuprofen lizin Imbun Zäpfchen 500 mg
OM Pharma, S.A.
Generis Farmacêutica, S.A.
IBU-LYSINratiopharm 684 mg Filmtabletten
Ibuprofen lizin IBU-LYSINratiopharm 684 mg Filmtabletten
LABORATORIOS JUVENTUS, S.A.
LABORATORIOS NORMON, S.A.
Ibuprofen Lysine Mylan
Ibuprofen lizin Ibuprofen Lysine Mylan
Ibuprofen (als lysine) Mylan 200 mg, filmomhulde tabletten
Ibuprofen lizin Ibuprofen (als lysine) Mylan 200 mg, filmomhulde tabletten
IBUPROFENO FARLINE 400 mg comprimidos bucodispersables
IBUPROFENO ASTREL 400 mg comprimidos bucodispersables
Svilno 20
Darwinweg 20
Ibuprofen (als lysine) Mylan 400 mg, filmomhulde tabletten
Ibuprofen lizin Ibuprofen (als lysine) Mylan 400 mg, filmomhulde tabletten
Ibuprofen Lysine Mylan 200 mg
Ibuprofen lizin Ibuprofen Lysine Mylan 200 mg
IBU-LYSINratiopharm 342 mg Filmtabletten
Ibuprofen lizin IBU-LYSINratiopharm 342 mg Filmtabletten
Ibuprofen Lysine Mylan 400 mg
Ibuprofen lizin Ibuprofen Lysine Mylan 400 mg
Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal
Empreendimento Lagoas Park Edifício 7, 3º Piso
Nurofen Lysine 200 mg
NUROFEN (LEMON) 200 mg
Ibugesic 400 mg film-coated tablets
Ibugesic 400 mg filmcoated tablets
Ibuprofen "Alternova" Ibuprofen
Ibuprofen "Alternova" 600 mg
Deltaran 300 mg Filmtabletten
Deksibuprofen Deltaran 300 mg Filmtabletten
Maresme, s/n Polígono Urvasa 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain
Perpetua de la Mogoda (Barcelona) Spain
Zafen 400 Tablet, filmomhulde tabletten 400 mg
Ibuprofen arginin Zafen 400 Tablet, filmomhulde tabletten 400 mg
Crescent Pharma Limited Units 3 and 4
Crescent Pharma Limited
Ibuprofen Wrafton 400 mg, filmomhulde tabletten
Ibuprofen lizin Ibuprofen Wrafton 400 mg, filmomhulde tabletten
IBUPROFENO CINFA 40 MG/ML
Ibuprofeno Cinfa 400 mg
Estrada de Alfragide, 67Alfrapark - Edificio D 2610-008 Amadora Portugal
Estrada de Alfragide, 67 - Alfrapark, Edificio D
PharmaSwiss d.o.o.
PharmaSwiss d.o.o. Miramarska 23
Dexibuprofen "Gebro" 400 mgFilmtabletten
Deksibuprofen Movone 400 mgFilmtabletten
Zweigniederlassung Wick Pharma
Bronzactiv Pharma GmbH
Heumann Pharma GmbH & Co. Generika KG
Heumann Pharma GmbH & Co.
Sardenya, 350 08025 Barcelona Spain
C/ Grassot, 16 08025 Barcelona Spain
IBUPROFENRATIOPHARM 200 MG
Ibuprofen ratiopharm 200 mg
SERACTIL TABLETS 300MG
Deksibuprofen SERACTIL TABLETS 300MG
IBUPROFENO ASTREL 400 mg comprimidos recubiertos
Ibuprofen arginin ESPIDIFEN 400 mg comprimidos recubiertos
Ibuprofen EG 800 mg Ibuprofen
Ibuprofen EG 800 mg 800 mg
Monactil 200 mgFilmtabletten
Deksibuprofen Monactil 200 mgFilmtabletten
Atriscal 200 mgFilmtabletten
Deksibuprofen Atriscal 200 mgFilmtabletten
IBALGIN RAPID IBUPROFEN
Ibuprofen lizin Ibalgin Rapid
Ibuprofen Wrafton 200 mg, filmomhulde tabletten
Ibuprofen lizin Ibuprofen Wrafton 200 mg, filmomhulde tabletten
Ibu 600 - 1 A Pharma Ibuprofen
Ibu 600 - 1 A Pharma 600 mg
Ibuprofeno Phagecon Ibuprofen
Ibuprofen lizin WRAFTON LABS IBUPROFEN PERRIGO
Bronzactiv Pharma GmbH Carl-von-Linde-Str. 30 85716 Unterschleißheim Germany
Procter & Gamble Service GmbH Zweigniederlassung Wick Pharma Sulzbacher Str. 40 65824 Schwalbach / Taunus
Belupo, lijekovi i kozmetika d.d.
Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia
Ibuprofen Perrigo 400 mg
Ibuprofen lizin Ibuprofen Perrigo 400 mg
Mibe GmbH Arzneimittel Münchener Str. 15
Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany
Dexibuprofen "Gebro" 300 mgFilmtabletten
Deksibuprofen Movone 300 mgFilmtabletten
600 mg Coated tablet
600 MG Obložena tableta
IBUPROFENO (ARGININA) SANDOZ 600 mg GRANULADO PARA SOLUCION ORAL EFG
Ibuprofen arginin IBUPROFENO (ARGININA) SANDOZ 600 mg GRANULADO PARA SOLUCION
Alcobendas (Madrid), 28108 Spain
Alcobendas (Madrid),
Seractil 200 mgFilmtabletten
Deksibuprofen Seractil 200 mgFilmtabletten
NORVECTAN 600 Ibuprofen
Ibuprofen lizinata NORVECTAN 600 POLVO PARA
Ziebicka st. 40
Partyzancka st.
Ibu KD 400 mg akut Ibuprofen
Ibu KD 400 mg akut 400 mg
Atriscal 400 mgFilmtabletten
Deksibuprofen Atriscal 400 mgFilmtabletten
IBUPROFENO STADA GENERICOS 400 mg comprimidos recubiertos EFG
IBUPROFENO STADAGEN 400 mg comprimidos recubiertos EFG
Ibuprofen arginine 600 mg Granules for oral solution
Ibuprofen arginin IBUPROFENO (ARGININA) ZENTIVA 600 mg GRANULADO PARA SOLUCION
Ibuprofen Abbott 400 mg šumeće granule
Ibuprofen arginin ESPIDIDOL 400 mg GRANULADO PARA
Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal
Avenida Dr. Afonso Costa, 1370
MERCURY PHARMS IBUPROFEN TABLETS BP 600MG
PHARMS IBUPROFEN TABLETS BP 600MG
Íbúprófen Portfarma Ibuprofen
Ibuprofen lizinata ALOGESIA
Ibuprofen arginine 400 mg Granules for oral solution
Ibuprofen arginin IBUPROFENO (ARGININA) CINFA 400 mg GRANULADO PARA SOLUCION
Ibuprofen lysine 342 mg Tablet
Ibuprofen lizin Nurofen Migraine Pain 342 mg
Ibuprofen phenylephrine
Ibuprofen Fenilefrin
Ibuprofen Lannacher Ibuprofen
Ibuprofen lizin Ibuzin
Ibuprofen Aflofarm Ibuprofen
Ibuprofen Aflofarm 200 mg
DALKEITH LABS IBUPROFEN TABLETS BP 600MG
LABS IBUPROFEN TABLETS BP 600MG
ATRISCAL 400 mg comprimidos recubiertos con película
Deksibuprofen ATRISCAL 400 mg comprimidos recubiertos con película
IBUPROFENO (ARGININA) TECNIGEN 600 mg GRANULADO PARA SOLUCION ORAL EFG
TECNIGEN 600 mg GRANULADO PARA SOLUCION ORAL EFG
The Boots Company PLC Nottingham Support Office D90 West First 17
D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom
Perrdophen 400mg Ibuprofen lysine 684 mg Coated tablet
Ibuprofen lizin Perrdophen 400mg 684 mg
Ibuprofen Perrigo 200 mg potahované tablety
Ibuprofen lizin Ibuprofen Perrigo 200 mg potahované tablety
Estrada de Alfragide, 67Alfrapark, Edificio D 2610-008 Amadora Portugal
OM Pharma, S.A. R. da Indústria, 2Quinta Grande 2610 - 088 AmadoraLisboa
IBUPROFENO MYLAN PHARMACEUTICALS 600 mg comprimidos recubiertos con película EFG
MYLAN PHARMACEUTICALS 600 mg comprimidos recubiertos con película EFG
Seractil Dolo 200 mg filmtabletta
Deksibuprofen Seractil Dolo 200 mg filmtabletta
Plom 2-4, 5º planta 08038 Barcelona Spain
Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain
Ibuberl 400 mg
IBUFLUX 400 MG 400 mg
Infirst Healthcare Ltd. Strand 265
Infirst Healthcare Ltd.
Ibuprofen PB 400 mg Ibuprofen
Ibuprofen PB 400 mg 400 mg
Ibuprofen EG 200 mg Ibuprofen
Ibuprofen EG 200 mg 200 mg
IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG
IBUPROFENO STADA GENÉRICOS 600 mg comprimidos recubiertos con película EFG
1000 Ljubljana Slovenia
1800 Vilvoorde Belgium
Boehringer Ingelheim International GmbH Binger Straße 173
Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein
Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom
Department Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ
Nurofen Lysine 400 mg
NUROFENCAPS 400 mg
McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss
Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium
IBUPROFENO (ARGININA) CINFAMED 400 mg GRANULADO PARA SOLUCION ORAL EFG
CINFAMED 400 mg GRANULADO PARA SOLUCION ORAL EFG
Northamptonshire NN11 8PB United Kingdom
7 Sopwith Way, Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom
Nurofen 400 tablet Female, filmomhulde tabletten 400mg
Ibuprofen lizin Nurofen 400 tablet Female, filmomhulde tabletten 400mg
Drayton Fields Industrial Estate, Daventry
North Way Wealworth Industrial Estate
IBUPROFENO TEVA 400 mg comprimidos recubiertos con película EFG
IBUKERN 400 mg comprimidos recubiertos con película EFG
IBUPROFENO (ARGININA) CINFAMED 600 mg GRANULADO PARA SOLUCION ORAL EFG
CINFAMED 600 mg GRANULADO PARA SOLUCION ORAL EFG
Spidifen 400 tablet, filmomhulde tabletten 400 mg
Ibuprofen arginin Spidifen 400 tablet, filmomhulde tabletten 400 mg
Reckitt Benckiser Healthcare (UK) Ltd. Dansom Lane Hull HU8 7DS
Dansom Lane Hull HU8 7DS United Kingdom
Dexibuprofen "Gebro" 200 mgFilmtabletten
Deksibuprofen Dexibuprofen "Gebro" 200 mg
SERACTIL 400 mg comprimidos recubiertos con película
Deksibuprofen SERACTIL 400 mg comprimidos recubiertos con película
Deltaran 200 mg Filmtabletten
Deksibuprofen Deltaran 200 mg Filmtabletten
IBUPROFENO (ARGININA) RATIOPHARM 600 mg GRANULADO PARA SOLUCION ORAL EFG
RATIOPHARM 600 mg GRANULADO PARA SOLUCION ORAL EFG
Ibuprofen EG 600 mg Ibuprofen
Ibuprofen EG 600 mg 600 mg
DK-2800 Kongens Lyndby Denmark
Teva Danska A/S Parallelvej 10-12 DK-2800 Kongens Lyndby
Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Farmacêuticos, Sociedade Unipessoal, Lda.
IBUPROFENO (ARGININA) FARMALIDER 200 MG GRANULADO PARA SOLUCION ORAL
Ibuprofen arginin IBUPROFENO (ARGININA) MYLAN 600 mg GRANULADO PARA SOLUCION
Nurofen 400 tablet Migraine, filmomhulde tabletten 400 mg
Ibuprofen lizin Nurofen 400 tablet Migraine, filmomhulde tabletten 400 mg
Pharmachemie B.V. Swensweg 5
BGP Products s.r.o. Karadžičova 10
PADUDEN® 200 mg IBUPROFEN
PADUDEN® 200 mg 200 mg
Ibuprofen Rockspring 200 mg šumivý granulát
Ibuprofen arginin POINDOL 200 MG GRANULADO PARA
The active substance in Dany's BienenWohl is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Djelatna tvar u VMP Dany's BienenWohl je dozvoljena tvar kako je navedeno u tablici 1. priloga Uredbe Komisije (EU) br. 37/2010:
The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Vanjska temperatura tijekom primjene veterinarsko-medicinskog proizvoda Dany's BienenWohl treba biti najmanje 3 °C.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
<Datum prvog odobrenja:> <14/06/2018>
Sucrose Anise oil Eucalyptus oil
saharoza ulje anisa ulje eukaliptusa
The use of Dany's BienenWohl with the above dosing scheme only applies to hives with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.
Uporaba veterinarsko-medicinskog proizvoda Dany's BienenWohl prema prethodnom režimu doziranja primjenjuje se samo na košnice s okomitim okvirima kojima se može pristupiti s vrha budući da primjena proizvoda u drugim vrstama košnica nije istražena.
Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Dany's BienenWohl ne smije ući u vodene tokove jer to može biti opasno za ribe i druge vodene organizme.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 colonies treated displaying adverse reaction(s)) - common (more than 1 but less than 10 colonies in 100 colonies treated) - uncommon (more than 1 but less than 10 colonies in 1,000 colonies treated) - rare (more than 1 but less than 10 colonies in 10,000 colonies treated) - very rare (less than 1 colony in 10,000 colonies treated, including isolated reports.
Učestalost nuspojava određena je u skladu sa sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih kolonija pokazuju nuspojavu(e)) - česte (više od 1, ali manje od 10 kolonija na 100 tretiranih kolonija) - manje česte (više od 1, ali manje od 10 kolonija na 1 000 tretiranih kolonija)
Dany's BienenWohl should not be used when honey supers are present.
Dany's BienenWohl ne smije se koristiti ako su prisutne posude za prikupljanje meda.
TARGET SPECIES Honey bees (Apis mellifera)
Medonosne pčele (Apis mellifera)
Do not exceed the recommended dose and do not administer this veterinary medicinal product more than once.
Ne prekoračujte preporučenu dozu i ne primjenjujte ovaj veterinarsko-medicinski proizvod (VMP) više od jednog puta.
Powder:
Prah:
Place the bottle containing the oxalic acid dihydrate solution into warm (30 - 35 °C) water.
bocu koja sadrži otopinu dihidrata oksalne kiseline stavite u toplu vodu (30 - 35 °C).
Dany's BienenWohl must only be applied only once in brood-free colonies.
Dany's BienenWohl treba primijeniti samo jednokratno u kolonijama bez legla.
Oxalic acid is an organic acid used for the treatment of Varroa destructor.
5.1 Farmakodinamička svojstva Oksalna kiselina organska je kiselina koja se upotrebljava za liječenje varooze (Varroa destructor).
Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Dany's BienenWohl ima nagrizajuća svojstva i djeluje na pčelarsku opremu osjetljivu na nagrizanje.
Mix with Dany's BienenWohl solution before use.
Prije uporabe pomiješati s Dany's BienenWohl otopinom.
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/225/001-002
EU/2/18/225/002 (750 g solution)
EU/2/18/225/002 (750 g otopina)
Mix with Dany's BienenWohl powder as instructed, before use.
Prije uporabe pomiješati s Dany's BienenWohl prahom prema uputama.
EU/2/18/225/002 (750 g g solution)
EU/2/18/225/002 (otopina od 750 g)
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Dany's BienenWohl prah za disperziju za košnice saharoza
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Dany's BienenWohl otopina za disperziju za košnice dihidrat oksalne kiseline
PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET Periodička izvješća o neškodljivosti lijeka sinkroniziraju se i predaju u istim vremenskim razmacima kao i za referentni lijek.
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/225/001 (otopina od 375 g)
Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Dany's BienenWohl prah i otopina 39,4 mg/ml za disperziju za košnice za medonosne pčele
Preparation of the final bee-hive dispersion:
Priprema gotove disperzije za košnicu:
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Dany's BienenWohl prah i otopina 39,4 mg/ml za disperziju za košnice dihidrat oksalne kiseline
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g g solution)
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/225/001 (375 g otopina)
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
PRILOG I. SAŽETAK OPISA SVOJSTAVA
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Dany's BienenWohl prah i otopina za disperziju od 39,4 mg/ml za košnice za medonosne pčele
insecticides
FARMACEUTSKI
Dany's BienenWohl must only be applied once in brood-free colonies.
4.4 Posebna upozorenja za svaku od ciljnih vrsta životinja Dany's BienenWohl treba primijeniti jednokratno u kolonijama bez legla.
40 mg/ml Oral solution bottle (glass)
Bočica (staklo) 3,0 ml (6 milijuna IU/ml) 2 bočice + 12 injekcijskih setova4
Packaging
Sastav (koncentracija)
The treatment should be repeated every two to six weeks.
Liječenje treba ponoviti svakih dva do šest tjedana.
Evoltra clofarabine
Evoltra klofarabin
Evoltra has been authorised under ‘exceptional circumstances'.
Lijek Evoltra odobren je u „iznimnim okolnostima”.
The average age of the treated patients was 12 years.
Prosječna dob liječenih bolesnika bila je 12 godina.
This summary was last updated in 12-2015.
Ovaj sažetak posljednji je put ažuriran u 12.2015.
It is given by infusion lasting two hours every day for five days.
Daje se pet dana u obliku infuzije koja traje 2 sata svaki dan.
The recommended dose is 52 mg per square metre of body surface area (calculated using the patient's height and weight).
Preporučena doza iznosi 52 mg po kvadratnom metru tjelesne površine (izračunato temeljem visine i tjelesne težine bolesnika).
The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Evoltra na snazi u Europskoj uniji od 29. svibnja 2006.
The most common side effects with Evoltra (seen in more than 1 patient in 10) were febrile neutropenia (low white blood cell counts with fever), anxiety, headache, flushing (reddening of the face), vomiting, diarrhoea, nausea (feeling sick), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), pruritus (itching), pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth) and fatigue (tiredness).
Najčešće nuspojave lijeka Evoltra (uočene u više od 1 na 10 bolesnika) bile su neutropenijska vrućica (niska razina bijelih krvnih stanica s vrućicom), anksioznost, glavobolja, navala crvenila (crveni obrazi), povraćanje, proljev, mučnina (osjećaj slabosti), sindrom palmarno-plantarne eritrodizestezije (osip i utrnulost dlanova i stopala), pruritus (svrbež), pireksija (vrućica), upala sluznice (upala vlažnih površina tijela, kao što je upala sluznice usne šupljine) te umor (malaksalost).
Breast-feeding should be stopped before, during and after treatment with Evoltra.
Dojenje treba prekinuti prije, za vrijeme i nakon liječenja lijekom Evoltra.
In the main study, 20% of the patients went into remission (12 out of 61).
U glavnom je ispitivanju zabilježena remisija kod 20 % bolesnika (12 od 61).
What measures are being taken to ensure the safe and effective use of Evoltra?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Evoltra?
Stem cells are cells that can develop into different types of cell.
Matične stanice su stanice koje se mogu razviti u različite vrste stanica.
Overall, the patients in the study survived for an average of 66 weeks.
Sveukupno su bolesnici u ispitivanju u prosjeku preživjeli 66 tjedana.
Because the number of patients with ALL is low, the disease is considered ‘rare', and Evoltra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 February 2002.
Budući da je broj bolesnika s ALL-om nizak, bolest se smatra „rijetkom” te se Evoltra označava kao lijek za liječenje rijetkih bolesti od 5. veljače 2002.
Other information about Evoltra
Ostale informacije o lijeku Evoltra
It is used when the disease has not responded to or has come back (relapsed) after at least two other treatments, and when no other treatment is expected to work.
Koristi se kada se bolest nije počela povlačiti ili se vratila (došlo je do relapsa) nakon barem dva druga oblika liječenja i kada se ne očekuje djelovanje niti jednog drugog oblika liječenja.
The full EPAR for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Evoltra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Evoltra must not be given to patients with severe kidney or liver disease.
Lijek Evoltra ne smije se dati bolesnicima s teškim bolestima bubrega ili jetre.
Evoltra is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), which is a cancer of the lymphocytes (a type of white blood cell).
Evoltra se koristi za liječenje djece i odraslih u dobi do 21 godine koji imaju akutnu limfoblastičnu leukemiju (ALL), odnosno rak limfocita (vrste bijelih krvnih stanica).
For more information about treatment with Evoltra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Evoltra pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
The main measure of effectiveness was the number of patients who went into ‘remission' (clearance of leukaemia from the bone marrow and complete or partial recovery of blood cell counts to normal levels).
Glavna mjera učinkovitosti bio je broj bolesnika kod kojih je zabilježena remisija (povlačenje leukemije iz koštane srži i potpun ili djelomičan povrat broja krvnih stanica na uobičajene razine).
This is a summary of the European public assessment report (EPAR) for Evoltra.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Evoltra.
It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Dostupan je kao koncentrat od kojega se pravi otopina za infuziju (drip) u venu.
The study did not compare Evoltra with any other treatments.
Tijekom ispitivanja lijek Evoltra nije uspoređen ni s jednim drugim oblikom liječenja.
Evoltra has been examined in one study of 61 patients below 21 years of age with ALL.
Lijek Evoltra ispitan je u jednom ispitivanju na 61 bolesniku mlađem od 21 godine koji je imao ALL.
All of the patients had previously received at least two other types of treatment but were not eligible for any other treatment.
Svi su bolesnici prije toga primili barem dva druga oblika liječenja, no nisu ispunjavali uvjete ni za jedan drugi oblik liječenja.
It belongs to the group of cancer medicines called ‘antimetabolites'.
Ubraja se u grupu lijekova protiv raka naziva „antimetaboliti”.
The summary of opinion of the Committee for Orphan Medicinal Products for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Evoltra dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
Evoltra treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias.
Liječenje lijekom Evoltra mora započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s akutnim leukemijama.
Most patients who respond to treatment do so after one or two treatment cycles.
Kod većine bolesnika koji pozitivno reagiraju na liječenje do reakcije dolazi nakon jednog ili dva ciklusa liječenja.
Why has Evoltra been approved?
Zašto je Evoltra odobrena?
What is the risk associated with Evoltra?
Koji su rizici povezani s lijekom Evoltra?
This means that clofarabine takes the place of adenine in the body, and interferes with the enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
To znači da klofarabin u tijelu preuzima mjesto adenina i ometa enzime koji sudjeluju u izgradnji genetskog materijala, odnosno DNK polimerazu i RNK reduktazu.
A risk management plan has been developed to ensure that Evoltra is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Evoltra.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evoltra, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Evoltra nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Patients with ALL who have not responded to or who have relapsed after receiving at least two treatments have a very poor chance of survival.
Bolesnici koji imaju ALL i koji nisu pozitivno reagirali na liječenje ili u kojih je došlo do relapsa nakon barem dva oblika liječenja imaju jako malu šansu za preživljavanje.
After treatment with Evoltra, 10 patients were able to go on to have a stem cell transplant.
Nakon liječenja lijekom Evoltra deset bolesnika bilo je sposobno za transplantaciju matičnih stanica.