FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence rates for larger decreases in eGFR (> 30%) at any time during treatment were 7.3, 8.1, and 6.5 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Croatian: Stope incidencije većih smanjenja eGFR (> 30%) u bilo kojem trenutku tijekom liječenja kanagliflozinom od 100 mg, kanagliflozinom od 300 mg, odnosno placebom iznosile su 7,3, 8,1 odnosno 6,5 događaja na 100 bolesnik-godina izloženosti.
English: Canagliflozin 300 mg + metformin XR (N = 237)
Croatian: Kanagliflozin 300 mg + metformin XR (N = 237)
English: Canagliflozin 100 mg titrated to 300 mg p < 0.01 compared to placebo
Croatian: Kanagliflozin 100 mg titriran do 300 mg p < 0,01 u usporedbi s placebom 90,7% ispitanika u skupini s kanagliflozinom titrirano je na 300 mg
English: Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi nekrotizirajućeg fasciitisa perineuma u bolesnica i bolesnika koji uzimaju SGLT2 inhibitore (što je poznato i kao Fournierova gangrena).To je rijedak, no ozbiljan i potencijalno po život opasan događaj koji zahtijeva hitnu kiruršku intervenciju i liječenje antibioticima.
English: Canagliflozin 100 mg + metformin XR (N = 237)
Croatian: Kanagliflozin 100 mg + metformin XR (N = 237)
English: * Intent-to-treat population
Croatian: * „Intent to treat“ populacija (planirana za liječenje)
English: In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to
Croatian: U kliničkom razvojnom programu bilo je procijenjeno 1085 bolesnika s početnom vrijednosti eGFR 30 ml/min/1,73 m2 do < 60 ml/min/1,73 m
English: The tablet is beige, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “551” on the other side.
Croatian: Tableta je bež boje, oblika kapsule, duljine 21 mm, filmom obložena, s “CM” utisnutim s jedne strane i “551” s druge strane.
English: EU/1/14/918/003 (50 mg/850 mg - 180 film-coated tablets) EU/1/14/918/006 (50 mg/1000 mg - 180 film-coated tablets) EU/1/14/918/009 (150 mg/850 mg - 180 film-coated tablets) EU/1/14/918/012 (150 mg/1000 mg - 180 film-coated tablets)
Croatian: EU/1/14/918/003 (50 mg/850 mg - 180 filmom obloženih tableta) EU/1/14/918/006 (50 mg/1000 mg - 180 filmom obloženih tableta) EU/1/14/918/009 (150 mg/850 mg - 180 filmom obloženih tableta) EU/1/14/918/012 (150 mg/1000 mg - 180 filmom obloženih tableta)
English: The tablet is pink, capsule-shaped, 20 mm in length, film-coated, and debossed with “CM” on one side and “358” on the other side.
Croatian: Tableta je ružičaste boje, oblika kapsule, duljine 20 mm, filmom obložena, s “CM” utisnutim s jedne strane i “358” s druge strane.
English: Ankle, below knee and above knee
Croatian: * Nožni prst i srednji dio stopala † Gležanj, potkoljenica i natkoljenica
English: Mean baseline eGFR was 62.5, 64.7, and 63.5 mL/min/1.73 m2 for canagliflozin 100 mg, canagliflozin 300 mg, and the control group, respectively (see sections 4.2 and
Croatian: na početku ispitivanja iznosila je 62,5, 64,7 i 63,5 ml/min/1,73 m2 u skupini koja je primala kanagliflozin od 100 mg i kanagliflozin od 300 mg, odnosno u kontrolnoj skupini (vidjeti dijelove 4.2 i 4.4).
English: The tablet is purple, capsule-shaped, 22 mm in length, film-coated, and debossed with “CM” on one side and “611” on the other side.
Croatian: Tableta je ljubičaste boje, oblika kapsule, duljine 22 mm, filmom obložena, s “CM” utisnutim s jedne strane i “611” s druge strane.
English: For patients on loop diuretics, the incidence rates were 5.0 on canagliflozin 100 mg and 5.7 on canagliflozin 300 mg compared to 4.1 events per 100 patient-years of exposure in the control group.
Croatian: Za bolesnike na diureticima Henleove petlje, stope incidencije bile su 5,0 i 5,7 događaja na 100 bolesnik-godina izloženosti uz kanagliflozin od 100 mg odnosno uz kanagliflozin od 300 mg u usporedbi s 4,1 događajem na 100 bolesnik-godina izloženosti u kontrolnoj skupini.
English: Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 2.7% for placebo.
Croatian: Srednje vrijednosti postotka promjene ureje u krvi u odnosu na početnu bila je 17,1% i 18,0% za kanagliflozin od 100 mg odnosno 300 mg u usporedbi s 2,7% za placebo.
English: The tablet is light yellow, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “418” on the other side.
Croatian: Tableta je svijetložute boje, oblika kapsule, duljine 21 mm, filmom obložena, s “CM” utisnutim s jedne strane i“418” s druge strane.
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2, the incidence rates were 5.2 on canagliflozin 100 mg and 5.4 on canagliflozin 300 mg compared to 3.1 events per 100 patient-years of exposure in the control group.
Croatian: < 60 ml/min/1,73 m2 stope incidencije bile su 5,2 i 5,4 događaja na 100 bolesnik-godina izloženosti uz kanagliflozin od 100 mg odnosno kanagliflozin od 300 mg u usporedbi s 3,1 događajem na 100 bolesnik-godina izloženosti u kontrolnoj skupini.
English: Patients with a baseline eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 treated with canagliflozin 100 mg and
Croatian: Bolesnici s početnom vrijednošću eGFR 45 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 liječeni kanagliflozinom od
English: Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 1.5% for placebo.
Croatian: Srednje vrijednosti postotka promjene kreatinina u odnosu na početnu bila je 2,8% i 4,0% za kanagliflozin od 100 mg odnosno 300 mg u usporedbi s 1,5% za placebo.
English: Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.0% for placebo.
Croatian: Srednje vrijednosti promjene hematokrita u odnosu na početnu bila je 2,4% i 2,5% za kanagliflozin od 100 mg odnosno 300 mg u usporedbi s 0,0% za placebo.
English: Mundipharma Pharmaceuticals B.V. Leusderend 24
Croatian: Mundipharma Pharmaceuticals B.V.
English: Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.6% for placebo.
Croatian: Srednje vrijednosti postotka promjene kalija u krvi u odnosu na početnu bila je 0,5% i 1,0% za kanagliflozin od 100 mg odnosno 300 mg u usporedbi s 0,6% za placebo.
English: Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg, compared to 1.5% for placebo.
Croatian: Srednje vrijednosti postotka promjene fosfata u krvi u odnosu na početnu bila je 3,6% i 5,1% za kanagliflozin od 100 mg odnosno 300 mg u usporedbi s 1,5% za placebo.
English: Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Croatian: Osip uključuje pojmove eritemni osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip, pruritički osip, pustularni osip i vezikularni osip.
English: Each 150 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Croatian: Jedna tableta od 150 mg/850 mg sadrži kanagliflozin hemihidrat, što odgovara 150 mg kanagliflozina i sadrži 850 mg metforminklorida.
English: Each 50 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Croatian: Jedna tableta od 50 mg/850 mg sadrži kanagliflozin hemihidrat, što odgovara 50 mg kanagliflozina i sadrži 850 mg metforminklorida.
English: Add-on therapy with insulin d (18 weeks)
Croatian: Dodatna terapija s inzulinom d (18 tjedana) Kanagliflozin + inzulin
English: Each 150 mg/1000 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Croatian: Jedna tableta od 150 mg/1000 mg sadrži kanagliflozin hemihidrat, što odgovara 150 mg kanagliflozina i sadrži 1000 mg metforminklorida.
English: Each 50 mg/1000 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Croatian: Jedna tableta od 50 mg/1000 mg sadrži kanagliflozin hemihidrat, što odgovara 50 mg kanagliflozina i sadrži 1000 mg metforminklorida.
English: increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Croatian: Dijabetička ketoacidoza (rijetko, može se javiti u do 1 na 1000 osoba) Ovo su znakovi dijabetičke ketoacidoze (također pogledajte dio 2): povišene razine “ketonskih tijela” u mokraći ili krvi nagli gubitak tjelesne težine mučnina ili povraćanje bol u trbuhu prekomjerna žeđ ubrzano i duboko disanje smetenost neuobičajena pospanost ili umor zadah slatkog mirisa, slatki ili metalni okus u ustima ili drugačiji miris mokraće ili znoja.
English: The overall incidence rate of elevated serum potassium was higher in patients with moderate renal impairment with incidence rates of 4.9, 6.1, and 5.4 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Croatian: Ukupna stopa incidencije povišenog kalija u serumu bila je viša u bolesnika s umjerenim oštećenjem bubrega uz kanagliflozin od 100 mg, kanagliflozin od 300 mg, odnosno placebo, sa stopama incidencije od 4,9, 6,1 odnosno 5,4 događaja na 100 bolesnik-godina izloženosti.
English: EU/1/14/918/010 (20 film-coated tablets) EU/1/14/918/011 (60 film-coated tablets) EU/1/14/918/012 (180 film-coated tablets)
Croatian: EU/1/14/918/010 (20 filmom obloženih tableta) EU/1/14/918/011 (60 filmom obloženih tableta) EU/1/14/918/012 (180 filmom obloženih tableta)
English: Baseline (mean) 8.81 Change from baseline (adjusted mean) -1.30 Difference from canagliflozin 100 mg (adjusted mean) (95% CI)
Croatian: Promjena od početne vrijednosti (prilagođena srednja vrijednost) Razlika u odnosu na kanagliflozin od 100 mg (prilagođena srednja vrijednost) (95% CI)
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and non-steroidal anti-inflammatory drugs [NSAIDs]) should be initiated with caution in Vokanamettreated patients.
Croatian: U bolesnika liječenih lijekom Vokanamet potreban je oprez kad se započinje s primjenom lijekova koji mogu akutno oštetiti funkciju bubrega (kao što su antihipertenzivi, diuretici i nesteroidni protuupalni lijekovi [NSAIL-ovi]).
English: Body weight Baseline (mean) in kg % change from baseline (adjusted mean) -2.1 Difference from metformin XR (adjusted mean) (95% CI)
Croatian: Početna vrijednost (srednja vrijednost) u kg % promjene od početne vrijednosti (prilagođena srednja vrijednost) Razlika u odnosu na placebo (prilagođena srednja vrijednost) (95% CI)
English: < 60 mL/min/1.73 m2, canagliflozin provided clinically meaningful reduction in HbA1c compared to placebo, with -0.47% for canagliflozin 100 mg and -0.52% for canagliflozin 300 mg.
Croatian: U analizi objedinjenih podataka bolesnika (N = 721) s početnom vrijednošću eGFR 45 ml/min/1,73 m do < 60 ml/min/1,73 m2, kanagliflozin je doveo do klinički značajnog smanjenja HbA1c u usporedbi s placebom, s -0,47% za kanagliflozin od 100 mg i -0,52% za kanagliflozin od 300 mg.
English: Change from baseline (adjusted mean) -0.85 Difference from placebo (adjusted mean) (95% CI)
Croatian: Promjena od početne vrijednosti (prilagođena srednja vrijednost) Razlika u odnosu na placebo (prilagođena srednja vrijednost) (95% CI)
English: Patients with eGFR 45 mL/min/1.73 m 2 to < 60 mL/min/1.73 m In a pooled analysis of patients (N = 721) with a baseline eGFR 45 mL/min/1.73 m 2 to
Croatian: Bolesnici s eGFR 45 ml/min/1,73 m2 do < 60 ml/min/1,73 m
English: Film-coating: - 50 mg/850 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide red (E172) and iron oxide black (E172).
Croatian: Vokanamet 50 mg/850 mg filmom obložene tablete makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: - 50 mg/1000 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide yellow (E172), and iron oxide red (E172).
Croatian: Vokanamet 50 mg/1000 mg filmom obložene tablete makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172)
English: Baseline (mean) in kg % change from baseline (adjusted mean)
Croatian: Početna (srednja) vrijednost u kg % promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost)
English: EU/1/14/918/007 (20 film-coated tablets) EU/1/14/918/008 (60 film-coated tablets) EU/1/14/918/009 (180 film-coated tablets)
Croatian: EU/1/14/918/007 (20 filmom obloženih tableta) EU/1/14/918/008 (60 filmom obloženih tableta) EU/1/14/918/009 (180 filmom obloženih tableta)
English: - 150 mg/1000 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide red (E172) and iron oxide black (E172).
Croatian: Vokanamet 150 mg/1000 mg filmom obložene tablete makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: EU/1/14/918/004 (20 film-coated tablets) EU/1/14/918/005 (60 film-coated tablets) EU/1/14/918/006 (180 film-coated tablets)
Croatian: EU/1/14/918/004 (20 filmom obloženih tableta) EU/1/14/918/005 (60 filmom obloženih tableta) EU/1/14/918/006 (180 filmom obloženih tableta)
English: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 850 mg metformin hydrochloride.
Croatian: Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 50 mg kanagliflozina i sadrži 850 mg metforminklorida.
English: - 150 mg/850 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), and iron oxide yellow (E172).
Croatian: Vokanamet 150 mg/850 mg filmom obložene tablete makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, žuti (E172)
English: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 850 mg metformin hydrochloride.
Croatian: Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 150 mg kanagliflozina i sadrži 850 mg metforminklorida.
English: EU/1/14/918/001 (20 film-coated tablets) EU/1/14/918/002 (60 film-coated tablets) EU/1/14/918/003 (180 film-coated tablets)
Croatian: EU/1/14/918/001 (20 filmom obloženih tableta) EU/1/14/918/002 (60 filmom obloženih tableta) EU/1/14/918/003 (180 filmom obloženih tableta)
English: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 1000 mg metformin hydrochloride.
Croatian: Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 50 mg kanagliflozina i sadrži 1000 mg metforminklorida.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 1000 mg metformin hydrochloride.
Croatian: Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 150 mg kanagliflozina i sadrži 1000 mg metforminklorida.
English: Patients (%) achieving HbA1c < 7% 47.6 Body weight
Croatian: Bolesnici (%) koji su postigli HbA1c
English: < 60 mL/min/1.73 m2, and patients ≥ 75 years of age had generally higher incidences of these adverse reactions.
Croatian: U ovoj objedinjenoj analizi, bolesnici na diureticima Henleove petlje, bolesnici s početnom vrijednosti eGFR 30 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 i bolesnici starosti ≥ 75 godina imali su općenito veće incidencije ovih nuspojava.
English: • St. John's wort (a herbal medicine used to treat depression)
Croatian: • gospina trava (biljni lijek za liječenje depresije)
English: There were 2,011 patients with eGFR 30 to < 60 mL/min/1.73 m 2.
Croatian: Za bolesnike s početnom vrijednosti eGFR 30 ml/min/1,73 m2 do
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Croatian: 0,6 ml (10 mg/ml)
English: Subcutaneous use pre-filled syringe (glass)
Croatian: 6 mg otopina za injekciju potkožno napunjena štrcaljka (staklo)
English: Further information on Udenyca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Udenyca nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Udenyca and what is it used for?
Croatian: Što je Udenyca i za što se primjenjuje?
English: What measures are being taken to ensure the safe and effective use of Udenyca?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Udenyca?
English: This means that Udenyca is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Udenyca je vrlo sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
English: The most common side effect with Udenyca (which may affect more than 1 in 10 people) is pain in the bones.
Croatian: Najčešća nuspojava lijeka Udenyca (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
English: Side effects reported with Udenyca are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Udenyca pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Udenyca is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Croatian: Udenyca se daje kao pojedinačna doza od 6 mg koja se ubrizgava ispod kože najmanje 24 sata nakon kraja svakog ciklusa kemoterapije (terapije protiv raka).
English: Udenyca is a ‘biosimilar medicine'.
Croatian: Udenyca je „biosličan lijek”.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Croatian: Posebno se daje za skraćivanje trajanja neutropenije i sprječavanje febrilne neutropenije (kad je neutropenija popraćena vrućicom).
English: Other information about Udenyca
Croatian: Ostale informacije o lijeku Udenyca
English: What are the risks associated with Udenyca?
Croatian: Koji su rizici povezani s lijekom Udenyca?
English: Because Udenyca is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Udenyca.
Croatian: Budući da je lijek Udenyca biosličan lijek, ispitivanja djelotvornosti i sigurnosti pegfilgrastima provedena za lijek Neulasta nije potrebno ponavljati za lijek Udenyca.
English: The reference medicine for Udenyca is Neulasta.
Croatian: Referentni lijek za Udenyca je Neulasta.
English: An overview of Udenyca and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Udenyca i zašto je odobren u EU-u
English: Why is Udenyca authorised in the EU?
Croatian: Zašto je lijek Udenyca odobren u EU-u?
English: Udenyca can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Croatian: Lijek Udenyca izdaje se samo na liječnički recept, a terapiju mora započeti i pratiti liječnik s iskustvom u liječenju raka ili poremećaja krvi.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Udenyca has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Udenyca ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Neulasta te se u tijelu raspoređuje na isti način.
English: As for all medicines, data on the use of Udenyca are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Udenyca kontinuirano se prate.
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Udenyca outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Udenyca, kao i od lijeka Neulasta, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Udenyca have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Udenyca nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Filgrastim works by encouraging the
Croatian: Filgrastim stimulira koštanu srž na
English: Udenyca is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Croatian: Lijek Udenyca nije namijenjen za korištenje u bolesnika s rakom krvi, kroničnom mijeloidnom leukemijom i mijelodisplastičnim sindromima (stanjima kod kojih se stvara veliki broj abnormalnih krvnih stanica, koja se mogu razviti u leukemiju).
English: For more information about using Udenyca, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Udenyca pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Croatian: stvaranje više bijelih krvnih stanica, što dovodi do povećanja broja bijelih krvnih stanica i liječenja neutropenije.
English: All these data were considered sufficient to conclude that Udenyca will behave in the same way as Neulasta in terms of effectiveness and safety in its approved uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Udenyca za odobrene indikacije djelovati na isti način kao lijek Neulasta u pogledu djelotvornosti i sigurnosti.
English: How does Udenyca work?
Croatian: Kako djeluje Udenyca?
English: The active substance in Udenyca, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Croatian: Djelatna tvar u lijeku Udenyca, pegfilgrastim, sastoji se od filgrastima, koji je vrlo sličan ljudskoj bjelančevini naziva faktor stimulacije rasta granulocita (G-CSF).
English: Laboratory studies comparing Udenyca with Neulasta have shown that the active substance in Udenyca is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Udenyca i Neulasta pokazala su da je djelatna tvar u lijeku Udenyca vrlo slična djelatnoj tvari u lijeku Neulasta u pogledu strukture, čistoće i biološke aktivnosti.
English: Udenyca is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Croatian: Udenyca je lijek koji se primjenjuje u bolesnika s rakom radi ublaživanja neutropenije (niskih razina neutrofila, vrste bijelih krvnih stanica), koja je česta nuspojava liječenja raka i koja može dovesti do osjetljivosti bolesnika na infekcije.
English: In Udenyca, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: U lijeku Udenyca filgrastim je „pegiliran” (konjugiran s kemijskom tvari koja se naziva polietilenglikol).
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Croatian: Lijek je dostupan u obliku prethodno napunjene štrcaljke koja sadrži otopinu za potkožnu injekciju.