FrancophonIA/ELRC3.0 huggingface dataset:
English: Plom 2-4, 5º planta 08038 Barcelona Spain
Croatian: Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain
English: Ibuprofen 600mg Effervescent Granules
Croatian: Brufen 600mg Effervescent Granules
English: Ibuberl 400 mg
Croatian: IBUFLUX 400 MG 400 mg
English: Infirst Healthcare Ltd. Strand 265
Croatian: Infirst Healthcare Ltd.
English: Ibuprofen PB 400 mg Ibuprofen
Croatian: Ibuprofen PB 400 mg 400 mg
English: Ibuprofen EG 200 mg Ibuprofen
Croatian: Ibuprofen EG 200 mg 200 mg
English: IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG
Croatian: IBUPROFENO STADA GENÉRICOS 600 mg comprimidos recubiertos con película EFG
English: Ibuprofen "Orifarm" Ibuprofen
Croatian: Ibuprofen "Orifarm" 600 mg
English: 1000 Ljubljana Slovenia
Croatian: 1800 Vilvoorde Belgium
English: Boehringer Ingelheim International GmbH Binger Straße 173
Croatian: Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein
English: Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom
Croatian: Department Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ
English: Nurofen Express 400 mg meke kapsule
Croatian: Nurofen Rapid Forte 400 mg meke kapsule
English: Nurofen Lysine 400 mg
Croatian: NUROFENCAPS 400 mg
English: McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss
Croatian: Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium
English: IBUPROFENO (ARGININA) CINFAMED 400 mg GRANULADO PARA SOLUCION ORAL EFG
Croatian: CINFAMED 400 mg GRANULADO PARA SOLUCION ORAL EFG
English: Northamptonshire NN11 8PB United Kingdom
Croatian: 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom
English: Nurofen 400 tablet Female, filmomhulde tabletten 400mg
Croatian: Ibuprofen lizin Nurofen 400 tablet Female, filmomhulde tabletten 400mg
English: Drayton Fields Industrial Estate, Daventry
Croatian: North Way Wealworth Industrial Estate
English: IBUPROFENO TEVA 400 mg comprimidos recubiertos con película EFG
Croatian: IBUKERN 400 mg comprimidos recubiertos con película EFG
English: IBUPROFENO (ARGININA) CINFAMED 600 mg GRANULADO PARA SOLUCION ORAL EFG
Croatian: CINFAMED 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Spidifen 400 tablet, filmomhulde tabletten 400 mg
Croatian: Ibuprofen arginin Spidifen 400 tablet, filmomhulde tabletten 400 mg
English: Reckitt Benckiser Healthcare (UK) Ltd. Dansom Lane Hull HU8 7DS
Croatian: Dansom Lane Hull HU8 7DS United Kingdom
English: Dexibuprofen "Gebro" 200 mgFilmtabletten
Croatian: Deksibuprofen Dexibuprofen "Gebro" 200 mg
English: SERACTIL 400 mg comprimidos recubiertos con película
Croatian: Deksibuprofen SERACTIL 400 mg comprimidos recubiertos con película
English: Deltaran 200 mg Filmtabletten
Croatian: Deksibuprofen Deltaran 200 mg Filmtabletten
English: IBUPROFENO (ARGININA) RATIOPHARM 600 mg GRANULADO PARA SOLUCION ORAL EFG
Croatian: RATIOPHARM 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Ibuprofen EG 600 mg Ibuprofen
Croatian: Ibuprofen EG 600 mg 600 mg
English: DK-2800 Kongens Lyndby Denmark
Croatian: Teva Danska A/S Parallelvej 10-12 DK-2800 Kongens Lyndby
English: Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Croatian: Farmacêuticos, Sociedade Unipessoal, Lda.
English: IBUPROFENO (ARGININA) FARMALIDER 200 MG GRANULADO PARA SOLUCION ORAL
Croatian: Ibuprofen arginin IBUPROFENO (ARGININA) MYLAN 600 mg GRANULADO PARA SOLUCION
English: Berkshire SL6 3UG United Kingdom
Croatian: Wrexham, LL13 9UF United Kingdom
English: Nurofen 400 tablet Migraine, filmomhulde tabletten 400 mg
Croatian: Ibuprofen lizin Nurofen 400 tablet Migraine, filmomhulde tabletten 400 mg
English: Pharmachemie B.V. Swensweg 5
Croatian: BGP Products s.r.o. Karadžičova 10
English: PADUDEN® 200 mg IBUPROFEN
Croatian: PADUDEN® 200 mg 200 mg
English: Ibuprofen Rockspring 200 mg šumivý granulát
Croatian: Ibuprofen arginin POINDOL 200 MG GRANULADO PARA
English: 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:
Croatian: Djelatna tvar u VMP Dany's BienenWohl je dozvoljena tvar kako je navedeno u tablici 1. priloga Uredbe Komisije (EU) br. 37/2010:
English: The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Croatian: Vanjska temperatura tijekom primjene veterinarsko-medicinskog proizvoda Dany's BienenWohl treba biti najmanje 3 °C.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
Croatian: <Datum prvog odobrenja:> <14/06/2018>
English: Sucrose Anise oil Eucalyptus oil
Croatian: saharoza ulje anisa ulje eukaliptusa
English: 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.
Croatian: 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.
English: Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Croatian: Dany's BienenWohl ne smije ući u vodene tokove jer to može biti opasno za ribe i druge vodene organizme.
English: 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.
Croatian: 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)
English: Dany's BienenWohl should not be used when honey supers are present.
Croatian: Dany's BienenWohl ne smije se koristiti ako su prisutne posude za prikupljanje meda.
English: TARGET SPECIES Honey bees (Apis mellifera)
Croatian: Medonosne pčele (Apis mellifera)
English: Do not exceed the recommended dose and do not administer this veterinary medicinal product more than once.
Croatian: Ne prekoračujte preporučenu dozu i ne primjenjujte ovaj veterinarsko-medicinski proizvod (VMP) više od jednog puta.
English: Powder:
Croatian: Prah:
English: Place the bottle containing the oxalic acid dihydrate solution into warm (30 - 35 °C) water.
Croatian: bocu koja sadrži otopinu dihidrata oksalne kiseline stavite u toplu vodu (30 - 35 °C).
English: Dany's BienenWohl must only be applied only once in brood-free colonies.
Croatian: Dany's BienenWohl treba primijeniti samo jednokratno u kolonijama bez legla.
English: Oxalic acid is an organic acid used for the treatment of Varroa destructor.
Croatian: 5.1 Farmakodinamička svojstva Oksalna kiselina organska je kiselina koja se upotrebljava za liječenje varooze (Varroa destructor).
English: Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Croatian: Dany's BienenWohl ima nagrizajuća svojstva i djeluje na pčelarsku opremu osjetljivu na nagrizanje.
English: Mix with Dany's BienenWohl solution before use.
Croatian: Prije uporabe pomiješati s Dany's BienenWohl otopinom.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/225/001-002
English: EU/2/18/225/002 (750 g solution)
Croatian: EU/2/18/225/002 (750 g otopina)
English: Mix with Dany's BienenWohl powder as instructed, before use.
Croatian: Prije uporabe pomiješati s Dany's BienenWohl prahom prema uputama.
English: EU/2/18/225/002 (750 g g solution)
Croatian: EU/2/18/225/002 (otopina od 750 g)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Dany's BienenWohl prah za disperziju za košnice saharoza
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Dany's BienenWohl otopina za disperziju za košnice dihidrat oksalne kiseline
English: PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Croatian: 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.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/225/001 (otopina od 375 g)
English: Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Croatian: Dany's BienenWohl prah i otopina 39,4 mg/ml za disperziju za košnice za medonosne pčele
English: Preparation of the final bee-hive dispersion:
Croatian: Priprema gotove disperzije za košnicu:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Dany's BienenWohl prah i otopina 39,4 mg/ml za disperziju za košnice dihidrat oksalne kiseline
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g g solution)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/225/001 (375 g otopina)
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Croatian: Dany's BienenWohl prah i otopina za disperziju od 39,4 mg/ml za košnice za medonosne pčele
English: insecticides
Croatian: FARMACEUTSKI
English: Dany's BienenWohl must only be applied once in brood-free colonies.
Croatian: 4.4 Posebna upozorenja za svaku od ciljnih vrsta životinja Dany's BienenWohl treba primijeniti jednokratno u kolonijama bez legla.
English: 40 mg/ml Oral solution bottle (glass)
Croatian: Bočica (staklo) 3,0 ml (6 milijuna IU/ml) 2 bočice + 12 injekcijskih setova4
English: Packaging
Croatian: Sastav (koncentracija)
English: The treatment should be repeated every two to six weeks.
Croatian: Liječenje treba ponoviti svakih dva do šest tjedana.
English: Evoltra clofarabine
Croatian: Evoltra klofarabin
English: Evoltra has been authorised under ‘exceptional circumstances'.
Croatian: Lijek Evoltra odobren je u „iznimnim okolnostima”.
English: The average age of the treated patients was 12 years.
Croatian: Prosječna dob liječenih bolesnika bila je 12 godina.
English: This summary was last updated in 12-2015.
Croatian: Ovaj sažetak posljednji je put ažuriran u 12.2015.
English: It is given by infusion lasting two hours every day for five days.
Croatian: Daje se pet dana u obliku infuzije koja traje 2 sata svaki dan.
English: The recommended dose is 52 mg per square metre of body surface area (calculated using the patient's height and weight).
Croatian: Preporučena doza iznosi 52 mg po kvadratnom metru tjelesne površine (izračunato temeljem visine i tjelesne težine bolesnika).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Evoltra na snazi u Europskoj uniji od 29. svibnja 2006.
English: 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).
Croatian: 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).
English: Breast-feeding should be stopped before, during and after treatment with Evoltra.
Croatian: Dojenje treba prekinuti prije, za vrijeme i nakon liječenja lijekom Evoltra.
English: In the main study, 20% of the patients went into remission (12 out of 61).
Croatian: U glavnom je ispitivanju zabilježena remisija kod 20 % bolesnika (12 od 61).
English: What measures are being taken to ensure the safe and effective use of Evoltra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Evoltra?
English: Stem cells are cells that can develop into different types of cell.
Croatian: Matične stanice su stanice koje se mogu razviti u različite vrste stanica.
English: Overall, the patients in the study survived for an average of 66 weeks.
Croatian: Sveukupno su bolesnici u ispitivanju u prosjeku preživjeli 66 tjedana.
English: 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.
Croatian: 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.
English: Other information about Evoltra
Croatian: Ostale informacije o lijeku Evoltra
English: 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.
Croatian: 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.
English: The full EPAR for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Evoltra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Evoltra must not be given to patients with severe kidney or liver disease.
Croatian: Lijek Evoltra ne smije se dati bolesnicima s teškim bolestima bubrega ili jetre.
English: 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).
Croatian: 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).
English: For more information about treatment with Evoltra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Evoltra pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: 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).
Croatian: 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).
English: This is a summary of the European public assessment report (EPAR) for Evoltra.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Evoltra.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Croatian: Dostupan je kao koncentrat od kojega se pravi otopina za infuziju (drip) u venu.
English: The study did not compare Evoltra with any other treatments.
Croatian: Tijekom ispitivanja lijek Evoltra nije uspoređen ni s jednim drugim oblikom liječenja.
English: Evoltra has been examined in one study of 61 patients below 21 years of age with ALL.
Croatian: Lijek Evoltra ispitan je u jednom ispitivanju na 61 bolesniku mlađem od 21 godine koji je imao ALL.
English: All of the patients had previously received at least two other types of treatment but were not eligible for any other treatment.
Croatian: Svi su bolesnici prije toga primili barem dva druga oblika liječenja, no nisu ispunjavali uvjete ni za jedan drugi oblik liječenja.
English: It belongs to the group of cancer medicines called ‘antimetabolites'.
Croatian: Ubraja se u grupu lijekova protiv raka naziva „antimetaboliti”.
English: 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.
Croatian: 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.
English: Evoltra treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias.
Croatian: Liječenje lijekom Evoltra mora započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s akutnim leukemijama.
English: Most patients who respond to treatment do so after one or two treatment cycles.
Croatian: Kod većine bolesnika koji pozitivno reagiraju na liječenje do reakcije dolazi nakon jednog ili dva ciklusa liječenja.
English: Why has Evoltra been approved?
Croatian: Zašto je Evoltra odobrena?
English: What is the risk associated with Evoltra?
Croatian: Koji su rizici povezani s lijekom Evoltra?
English: 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'.
Croatian: To znači da klofarabin u tijelu preuzima mjesto adenina i ometa enzime koji sudjeluju u izgradnji genetskog materijala, odnosno DNK polimerazu i RNK reduktazu.
English: A risk management plan has been developed to ensure that Evoltra is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Evoltra.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: After treatment with Evoltra, 10 patients were able to go on to have a stem cell transplant.
Croatian: Nakon liječenja lijekom Evoltra deset bolesnika bilo je sposobno za transplantaciju matičnih stanica.
English: This stops the cells making new DNA and RNA, and slows down the growth of tumour cells.
Croatian: Time se stanice sprečava u izgradnji novoga DNK i RNK te se usporava rast tumorskih stanica.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evoltra.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Evoltra.
English: This is a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow.
Croatian: Transplantacija je složen postupak u kojem bolesnik prima matične stanice od odgovarajućeg darivatelja kako bi došlo do obnove koštane srži.
English: The company that makes Evoltra will set up a registry to monitor the medicine's side effects.
Croatian: Tvrtka koja proizvodi lijek Evoltra uspostavit će registar za praćenje nuspojava lijeka.
English: Clofarabine is an ‘analogue' of adenine, which is part of the fundamental genetic material of cells (DNA and RNA).
Croatian: Klofarabin je analogan adeninu koji je dio osnovnog genetskog materijala stanica (DNK i RNK).
English: The Committee decided that Evoltra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka Evoltra nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What information is still awaited for Evoltra?
Croatian: Koje se još informacije očekuju o lijeku Evoltra?
English: The active substance in Evoltra, clofarabine, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells).
Croatian: Djelatna tvar lijeka Evoltra, klofarabin, je citotoksik (lijek koji ubija stanice koje se dijele, kao što su stanice raka).
English: Evoltra is a cancer medicine that contains the active substance clofarabine.
Croatian: Evoltra je lijek protiv raka koji sadrži djelatnu tvar klofarabin.
English: This means that, because the disease is rare, it has not been possible to obtain complete information about Evoltra.
Croatian: Tome je razlog nemogućnost dobivanja potpunih informacija o lijeku Evoltra zbog rijetkosti bolesti.
English: What is Evoltra?
Croatian: Što je Evoltra?
English: The CHMP concluded that Evoltra treatment may provide a way of obtaining remission, and of facilitating a stem cell transplant.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) zaključio je da je lijekom Evoltra moguće postići remisiju i olakšati transplantaciju matičnih stanica.
English: What benefit has Evoltra shown during the studies?
Croatian: Koje su koristi lijeka Evoltra utvrđene u ispitivanjima?
English: What is Evoltra used for?
Croatian: Za što se Evoltra koristi?
English: For the full list of all side effects reported with Evoltra, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Evoltra potražite u uputi o lijeku.
English: How is Evoltra used?
Croatian: Kako se Evoltra koristi?
English: How has Evoltra been studied?
Croatian: Kako je Evoltra ispitivana?
English: How does Evoltra work?
Croatian: Kako djeluje Evoltra?
English: 30 sachets + 2 syringes + 1 mixing cup
Croatian: 30 vrećica + 2 štrcaljke + 1 čaša za miješanje
English: 100 mg Powder for Oral Suspension
Croatian: 100 mg prašak za oralnu suspenziju kroz usta vrećica (PE/alu/PET)
English: Wash your hands before opening the pack.
Croatian: Operite ruke prije otvaranja pakiranja.
English: This would be checked by your doctor.
Croatian: Vaš će liječnik to provjeriti.
English: Date of first authorisation: 12 May 2016
Croatian: Datum prvog odobrenja: 12. svibanj 2016.
English: See sections 5.1 and 5.2.
Croatian: Vidjeti dijelove 5.1 i 5.2.
English: Phone: +46 8 697 20 00
Croatian: Tel: +46 8 697 20 00
English: 1 See section 4.2; NA: Not available
Croatian: 1 Vidjeti dio 4.2; ND: Nije dostupno
English: 144h 168h 192h 240 h 288 h
Croatian: 24 h 48 h 96 h 144 h 168 h 192 h 240 h 288 h
English: You or somebody else may administer ALPROLIX after receiving adequate training.
Croatian: Vi ili netko drugi možete primjenjivati ALPROLIX nakon što dobijete odgovarajuću obuku.