FrancophonIA/ELRC3.0 huggingface dataset:
English: Eucreas is used to treat adult patients with type 2 diabetes.
Croatian: Eucreas se primjenjuje za liječenje bolesnika sa šećernom bolešću tipa
English: No data are available with regard to overdose of Eucreas.
Croatian: Nema dostupnih podataka o predoziranju Eucreasom.
English: Bioequivalence has been demonstrated between Eucreas at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Croatian: Potvrđena je bioekvivalencija triju jačina doza Eucreasa (50 mg/500 mg, 50 mg/850 mg i 50 mg/1000 mg) u usporedbi sa slobodnom kombinacijom tableta vildagliptina i metforminklorida u odgovarajućim dozama.
English: Animal studies of up to 13-week duration have been conducted with the combined substances in Eucreas.
Croatian: Ispitivanja kombinacije tvari iz Eucreasa provedena su na životinjama u trajanju do 13 tjedana.
English: Other side effects Some patients have experienced the following side effects while taking Eucreas:
Croatian: Neki su bolesnici imali sljedeće nuspojave kada su uzimali Eucreas:
English: A test to determine your liver function will be performed before the start of Eucreas treatment, at three-month intervals for the first year and periodically thereafter.
Croatian: Testovi jetrene funkcije će se napraviti prije početka liječenja Eucreasom, potom tijekom prve godine u razmacima od tri mjeseca te poslije toga periodički.
English: Metabolism and nutrition disorders Very rare
Croatian: Poremećaji metabolizma i prehrane Vrlo rijetko
English: - Eucreas is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.
Croatian: - Eucreas je indiciran u kombinaciji sa sulfonilurejom (tj. trojna kombinirana terapija) kao dodatak dijeti i tjelovježbi u odraslih bolesnika u kojih je kontrola nedostatna s metforminom i sulfonilurejom.
English: How to take Eucreas
Croatian: Kako uzimati Eucreas
English: - Eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Croatian: - Eucreas je indiciran u trojnoj kombiniranoj terapiji sa inzulinom kao dodatak dijeti i tjelovježbi za poboljšanje kontrole glikemije u odraslih bolesnika u kojih stabilna doza inzulina i metformina ne omogućuju odgovarajuću kontrolu glikemije.
English: LFTs should be performed prior to the initiation of treatment with Eucreas in order to know the patient's baseline value.
Croatian: Testove jetrene funkcije treba napraviti prije početka liječenja Eucreasom kako bi se utvrdile početne vrijednosti.
English: The dose of Eucreas should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Croatian: Doza lijeka Eucreas mora biti 50 mg vildagliptina dvaput na dan (ukupna dnevna doza 100 mg) i doza metformina slična dosadašnjoj dozi.
English: Eucreas may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Croatian: Liječenje Eucrasom može se započeti s jačinom tablete ili od 50 mg/850 mg ili od 50 mg/1000 mg dvaput na dan, kao jedna tableta ujutro i druga navečer.
English: Eucreas is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Croatian: Eucreas je dostupan u pakiranjima od 10, 30, 60, 120, 180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima od 120 (2x60), 180 (3x60) ili 360 (6x60) filmom obloženih tableta.
English: Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Eucreas (see sections 4.2, 4.3 and 4.8).
Croatian: Eucreas se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre, uključujući one u kojih su ALT ili AST prije početka liječenja bili >3x GGN (vidjeti dijelove 4.2, 4.3 i 4.8).
English: Eucreas 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Croatian: Eucreas 50 mg/1000 mg filmom obložene tablete su tamnožute, ovalne tablete s oznakom „NVR” na jednoj strain i „FLO” na drugoj strani.
English: How to store Eucreas
Croatian: Kako čuvati Eucreas
English: What Eucreas looks like and contents of the pack Eucreas 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Croatian: Eucreas 50 mg/850 mg filmom obložene tablete su žute, ovalne tablete s oznakom „NVR” na jednoj strain i „SEH” na drugoj strani.
English: Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Eucreas in order to avoid low blood glucose (hypoglycaemia).
Croatian: Da bi izbjegao nisku koncentraciju glukoze u krvi (hipoglikemija), Vaš će liječnik možda htjeti smanjiti Vašu dozu sulfonilureje kad je uzimate zajedno s Eucrasom.
English: Eucreas 50 mg/1000 mg film-coated tablets
Croatian: Eucreas 50 mg/1000 mg filmom obložene tablete
English: Eucreas 50 mg/850 mg film-coated tablets
Croatian: Eucreas 50 mg/850 mg filmom obložene tablete
English: - if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Croatian: Ako mislite da biste mogli biti alergični na bilo što od navedenog, razgovarajte sa svojim liječnikom prije uzimanja Eucreasa. - ako imate nekontroliranu šećernu bolest, uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti “Rizik od laktacidoze” niže) ili ketoacidozu.
English: - Each Eucreas 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Croatian: - Jedna Eucreas 50 mg/1000 mg filmom obložena tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina).
English: - Each Eucreas 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Croatian: - Jedna Eucreas 50 mg/850 mg filmom obložena tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina).
English: Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets
Croatian: Eucreas 50 mg/850 mg filmom obložene tablete Eucreas 50 mg/1000 mg filmom obložene tablete
English: Polychlorotrifluoroethylene (PCTFE)/PVC/Alu blister Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Croatian: Dostupno u pakiranjima koja sadrže 10, 30, 60, 120, 180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima koja sadrže 120 (2 pakiranja od 60), 180 (3 pakiranja od 60) ili 360 (6 pakiranja od 60) filmom obloženih tableta.
English: Talk to your doctor, pharmacist or nurse before taking Eucreas if you have or have had a disease of the pancreas.
Croatian: Ako imate ili ste imali bolest gušterače, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Eucreas.
English: Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Croatian: Eucreas 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
English: Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Croatian: Eucreas 50 mg/850 mg filmom obložene tablete Eucreas 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
English: Eucreas 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Croatian: Eucreas 50 mg/850 mg filmom obložene tablete vildagliptin/metforminklorid
English: EU/1/07/425/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/030 360 film-coated tablets (PCTFE/PVC/Alu)
Croatian: EU/1/07/425/007 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/008 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/009 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/010 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/011 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/012 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/025 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/026 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/027 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/028 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/029 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/030 360 filmom obloženih tableta (PCTFE/PVC/Al)
English: EU/1/07/425/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/024 360 film-coated tablets (PCTFE/PVC/Alu)
Croatian: EU/1/07/425/001 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/002 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/003 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/004 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/005 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/006 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/019 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/020 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/021 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/022 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/023 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/024 360 filmom obloženih tableta (PCTFE/PVC/Al)
English: EU/1/07/425/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/036 360 film-coated tablets (PCTFE/PVC/Alu)
Croatian: EU/1/07/425/016 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/017 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/018 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/034 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/035 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/036 360 filmom obloženih tablet (PCTFE/PVC/Al)
English: EU/1/07/425/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/07/425/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/07/425/033 360 film-coated tablets (PCTFE/PVC/Alu)
Croatian: EU/1/07/425/013 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/014 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/015 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/07/425/031 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/032 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/07/425/033 360 filmom obloženih tableta (PCTFE/PVC/Al)
English: - For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Eucreas should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Croatian: Uobičajena početna doza Eucreasa mora biti 50 mg vildagliptina dvaput na dan (ukupna dnevna doza 100 mg) plus dosadašnja doza metformina.
English: EU/1/99/097/001 Beromun
Croatian: EU/1/99/097/001 Beromun 1 mg
English: vial (glass)
Croatian: bočica (staklo)
English: Isolated limb perfusion (intra-arterial use)
Croatian: Namijenjeno primjeni putem izolirane perfuzije ekstremiteta (primjena u arteriju)
English: Immediate Packaging
Croatian: Unutarnje pakovanje Sastav Veličina pakovanja
English: MA (EU) number Invented name Strength Pharmaceutical form
Croatian: Doza Farmaceutski oblik Put primjene
English: Primula flower EMA/423706/2016EMA/423706/2016
Croatian: EMA/423706/2016
English: Allergic reactions have been reported with these medicines.
Croatian: Tijekom primjene ovih lijekova zabilježene su alergijske reakcije.
English: Primula veris L. and/or Primula elatior (L.) Hill, flos
Croatian: Primula veris L. i/ili Primula elatior (L.) Hill, flos
English: If symptoms last longer than one week or worsen during the use of the medicine, a doctor or a qualified
Croatian: Ako simptomi traju dulje od jednog tjedna ili se pogoršaju tijekom primjene, potrebno je obratiti se liječniku ili kvalificiranom zdravstvenom radniku.
English: What is primula flower?
Croatian: Što je jaglačev cvijet?
English: Primula flower medicines should only be used in adults and adolescents over the age of 12 years.
Croatian: Lijekovi koji sadrže jaglačev cvijet smiju se koristiti samo u odraslih osoba i adolescenata starijih od 12 godina.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/423706/2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● Ujedinjena Kraljevina
English: No clinical studies have been carried out with primula flower.
Croatian: Nisu provedena klinička ispitivanja s jaglačevim cvijetom.
English: Primula flower is the common name for the flowers of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Croatian: Jaglačev cvijet je uobičajen naziv za cvjetove biljke Primula veris L. i/ili Primula elatior (L.) Hill.
English: The HMPC conclusions only cover primula flower preparations which are obtained by comminuting (reducing into tiny pieces) the flowers or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Croatian: Zaključcima HMPC-a obuhvaćeni su samo pripravci jaglačevog cvijeta koji su dobiveni usitnjavanjem (smanjivanjem na manje komadiće) cvjetova ili primjenom tehnike za ekstrakciju spojeva stavljanjem biljnog materijala u otapalo (npr. etanol) radi otapanja spojeva i dobivanja tekućeg ekstrakta.
English: Further information on the HMPC assessment of primula flower medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Daljnje informacije o HMPC-ovoj ocjeni lijekova koji sadrže jaglačev cvijet, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This summary is not intended to provide practical advice on how to use medicines containing primula flower.
Croatian: Svrha ovog sažetka nije davati praktične savjete o načinu primjene lijekova koji sadrže jaglačev cvijet.
English: Any applications for the licensing of medicines containing primula flower have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže jaglačev cvijet moraju se podnijeti nacionalnim tijelima nadležnima za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the risks associated with these primula flower medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više o rizicima povezanim s ovim lijekovima koji sadrže jaglačev cvijet, uključujući odgovarajuće mjere opreza za njihovu sigurnu primjenu, možete pronaći u monografiji pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Information on the use and licensing of primula flower medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o primjeni i davanju odobrenja za lijekove koji sadrže jaglačev cvijet u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: The HMPC conclusions on the use of these primula flower medicines for coughs are based on their ‘traditional use' .
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže jaglačev cvijet za kašalj temelje se na njihovoj „tradicionalnoj primjeni”.
English: Primula flower medicines must not be used in patients who are allergic to primula flower or to other plants of the primula species.
Croatian: Lijekovi koji sadrže jaglačev cvijet ne smiju se primjenjivati u bolesnika koji su alergični na jaglačev cvijet ili druge biljne vrste iz roda Primula.
English: Herbal medicines containing these primula flower preparations are usually available as herbal tea to be drunk and in liquid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže te pripravke jaglačevog cvijeta najčešće su dostupni kao biljni čaj koji se pije i u tekućem obliku za uzimanje kroz usta.
English: Primula flower preparations may also be found in combination with other herbal substances in some herbal medicines.
Croatian: Pripravci jaglačevog cvijeta mogu postojati također i u kombinaciji s drugim biljnim tvarima u nekim biljnim lijekovima.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula flower.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske primjene jaglačevog cvijeta.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing primula flower.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže jaglačev cvijet.
English: Detailed instructions on how to take primula flower medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu uzimanja lijekova koji sadrže jaglačev cvijet i o tome tko ih smije uzimati navedene su u uputi o lijeku koja je priložena uz lijek.
English: Other information about primula flower medicines
Croatian: Ostale informacije o lijekovima koji sadrže jaglačev cvijet
English: What are the risks associated with primula flower medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže jaglačev cvijet?
English: In its assessment, the HMPC considered laboratory studies which showed primula flower increased production of airway secretions, making phlegm less thick and easier to expel.
Croatian: Prilikom svoje ocjene HMPC je razmotrio ispitivanja provedena u laboratoriju koja su pokazala da je jaglačev cvijet povećao stvaranje sekreta u dišnim putovima, čime je smanjio gustoću sluzi i olakšao iskašljavanje.
English: For more information about treatment with primula flower medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekovima koji sadrže jaglačev cvijet pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: The HMPC concluded that, on the basis of its long-standing use, these primula flower primula flower preparations can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Croatian: Na temelju dugotrajne primjene, HMPC je zaključio da se ovi pripravci jaglačevog cvijeta mogu koristiti kao ekspektorans (lijek za olakšavanje iskašljavanja sluzi) za kašalj uslijed prehlade.
English: For practical information about using primula flower medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o primjeni lijekova koji sadrže jaglačev cvijet bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: What evidence supports the use of primula flower medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže jaglačev cvijet?
English: How are primula flower medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže jaglačev cvijet?
English: 26 April 2019
Croatian: Dana 26. travnja 2019.
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Croatian: Tvrtka može zatražiti ponovno ispitivanje mišljenja u roku od 15 dana od primitka obavijesti o ovom negativnom mišljenju.
English: To support this claim, the company referred to published data and provided an expert opinion.
Croatian: U prilog toj tvrdnji tvrtka se pozvala na objavljene podatke i dostavila mišljenje stručnjaka.
English: Data from clinical studies also showed differences in the safety profile of the two active substances.
Croatian: Podatci iz kliničkih ispitivanja ujedno su pokazali različitosti u sigurnosnom profilu dviju djelatnih tvari.
English: The company that applied for authorisation is Teva B.V.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka Teva B.V.
English: Furthermore, patients receiving cabazitaxel are exposed to the unchanged substance plus two active breakdown products, which are not formed when docetaxel is given.
Croatian: Nadalje, bolesnici koji primaju kabazitaksel izloženi su nepromijenjenoj tvari i dvama aktivnim proizvodima razgradnje koji se ne stvaraju kada se daje docetaksel.
English: Cabazitaxel Teva was developed as a ‘hybrid medicine'.
Croatian: Cabazitaxel Teva je razvijen kao „hibridni lijek”.
English: Additionally, laboratory data suggest that cabazitaxel can be effective at treating cancer that is resistant to docetaxel.
Croatian: Osim toga, laboratorijski podatci upućuju na to da kabazitaksel može biti učinkovit u liječenju raka koji je otporan na docetaksel.
English: The applicant also made reference to another medicine, Taxotere, which contains docetaxel.
Croatian: Podnositelj zahtjeva također se pozvao na drugi lijek, Taxotere, koji sadrži docetaksel.
English: There was no need for ‘bioequivalence' studies to investigate whether Cabazitaxel Teva is absorbed similarly to Jevtana to produce the same level of the active substance in the blood.
Croatian: Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Cabazitaxel Teva na sličan način kao lijek Jevtana kako bi proizveo istu razinu djelatne tvari u krvi.
English: Because Cabazitaxel Teva was developed as a hybrid medicine, the company presented data from the published literature to demonstrate that it is similar to Jevtana.
Croatian: Budući da je Cabazitaxel Teva razvijen kao hibridni lijek, tvrtka je dostavila podatke iz objavljene literature kako bi dokazala da je sličan lijeku Jevtana.