FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Farydak
Croatian: Kako čuvati Farydak
English: • abdominal pain, diarrhoea, swelling or bloating of the abdomen (signs of inflamed stomach lining)
Croatian: • bol u trbuhu, proljev, oticanje ili nadutost trbuha (znakovi upaljene ovojnice želuca)
English: Haemorrhage intracranial, syncope, tremor, dysgeusia
Croatian: Intrakranijalno krvarenje, sinkopa, tremor, poremećaj osjeta okusa
English: A dose escalation from 15 mg to 20 mg may be considered based on patient tolerability.
Croatian: Može se razmotriti povećanje doze s 15 mg na 20 mg na temelju bolesnikove podnošljivosti.
English: Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation and sinus tachycardia) were reported in 17.6% of panobinostat + bortezomib + dexamethasone-treated patients versus 9.8% of placebo + bortezomib + dexamethasone-treated patients and syncope events were reported in 6.0% versus 2.4%, respectively.
Croatian: Srčani događaji (najučestaliji fibrilacija atrija, tahikardija, palpitacija i sinusna tahikardija) bili su prijavljeni u 17,6% bolesnika liječenih panobinostatom + bortezomibom
English: A total of 768 patients were randomised in a 1:1 ratio to either the panobinostat + bortezomib + dexamethasone (n=387) or the placebo + bortezomib + dexamethasone (n=381) arm, stratified by prior use of bortezomib [Yes (n=336 (43.8%)), No (n=432 (56.3%))] and number of prior lines of anti-myeloma therapy [1 prior line (n=352 (45.8%)), 2 to 3 prior lines (n=416 (54.2%))].
Croatian: [Da (n=336 (43,8%)), Ne (n=432 (56,3%))] i broju prethodnih linija antimijelomske terapije [1 prethodna linija (n=352 (45,8%)), 2 do 3 prethodne linije (n=416 (54,2%))]. Demografske karakteristike i karakteristike bolesti na početku bile su uravnotežene i usporedive između terapijskih skupina.
English: If you have any questions about how Farydak works or why you have been given it, ask your doctor or pharmacist.
Croatian: Ako imate ikakvih pitanja o tome kako Farydak djeluje ili zašto
English: Farydak 15 mg hard capsules
Croatian: Farydak 15 mg tvrde kapsule
English: Decrease in blood cell count
Croatian: Smanjenje razina krvnih stanica
English: The median PFS (95% CI) was 12.5 months (7.26, 14.03) in the panobinostat + bortezomib + dexamethasone arm and 4.7 months (3.71, 6.05) in the placebo + bortezomib + and dexamethasone arm [HR: 0.47 (0.31, 0.72)].
Croatian: Medijan PFS-a (95% CI) bio je 12,5 mjeseci (7,26, 14,03) u skupini koja je primala panobinostat + bortezomib
English: The median duration of follow-up was 28.75 months in the panobinostat + bortezomib + dexamethasone arm and 29.04 months in the placebo + bortezomib + dexamethasone arm.
Croatian: Medijan trajanja praćenja bio je 28,75 mjeseci u skupini koja je primala panobinostat + bortezomib
English: 33.3% patients in the panobinostat + bortezomib + dexamethasone arm and 10.3% patients in the placebo + bortezomib + dexamethasone arm received platelet transfusions during treatment.
Croatian: + deksametazon i 10,3% bolesnika koji su primali placebo + bortezomib
English: • flatulence
Croatian: • vjetrovi
English: Omit dose Resume at same dose
Croatian: Propustiti dozu Nastaviti u istoj dozi
English: Cardiac monitoring and assessment of electrolytes and platelet counts should be undertaken and supportive care given as necessary in the event of overdose.
Croatian: U slučaju predoziranja potrebno je provesti praćenje rada srca, pretrage elektrolita i broja trombocita te prema potrebi pružiti suportivnu skrb.
English: Kaplan Meier medians PAN+BTZ+Dex: 12.48 months PBO+BTZ+Dex: 4.70 months
Croatian: 95% CI [0,31; 0,72] Logrank p-vrijednost=0,0003 Kaplan Meierovi medijani PAN+BTZ+Dex: 12,48 mjeseci PBO+BTZ+Dex: 4,70 mjeseci
English: Farydak 10 mg hard capsules
Croatian: Farydak 10 mg tvrde kapsule
English: - For men taking Farydak
Croatian: • Za muškarce koji uzimaju Farydak
English: Farydak 20 mg hard capsules
Croatian: Farydak 20 mg tvrde kapsule
English: Infections and infestations Very common Upper respiratory tract infection, pneumonia
Croatian: Infekcija gornjeg dijela dišnog sustava, pneumonija
English: Panobinostat dose on recovery to grade 2 neutropenia
Croatian: Doza panobinostata nakon oporavka do neutropenije 2. stupnja
English: Panobinostat dose on recovery to ≤ grade 1
Croatian: Doza panobinostata nakon oporavka do ≤1. stupnja
English: Table 1 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 1-8)
Croatian: Tablica 1 Preporučeni raspored uzimanja Farydaka u kombinaciji s bortezomibom i deksametazonom (1.-8. ciklus)
English: Fatigue and asthenia
Croatian: Infekcije i infestacije
English: The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
Croatian: Drugi sastojci su: magnezijev stearat, manitol, mikrokristalična celuloza, prethodno geliran škrob, želatina, titanijev dioksid (E171), briljantno plava FCF (E133), žuti željezov oksid (E172), crni željezov oksid (E172), propilenglikol (E1520), glazura šelaka.
English: Omit dose Resume at reduced dose
Croatian: Propustiti dozu Nastaviti u smanjenoj dozi
English: Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Croatian: željezov oksid, žuti (E172) Farydak 15 mg tvrde kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: Very common Weight decreased Common
Croatian: Smanjena tjelesna težina
English: • stomach or abdominal pain, nausea, diarrhoea, vomiting, black or bloody stools, constipation,
Croatian: • bol u želucu ili trbuhu, mučnina, proljev, povraćanje, crna ili krvava stolica, zatvor, žgaravica, oticanje ili nadutost trbuha (znakovi želučano-crijevnog problema)
English: QT prolongation and ECG abnormalities
Croatian: Produljenje QT-a i poremećaji EKG-a
English: Microcrystalline cellulose Pregelatinised starch (maize)
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Sadržaj kapsule magnezijev stearat manitol celuloza, mikrokristalična škrob, prethodno geliran (kukuruzni)
English: Rest period
Croatian: ROK VALJANOSTI
English: The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
Croatian: Drugi sastojci su: magnezijev stearat, manitol, mikrokristalična celuloza, prethodno geliran škrob, želatina, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172), propilenglikol (E1520), glazura šelaka.
English: Package leaflet: Information for the patient Farydak 10 mg hard capsules
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Farydak 10 mg tvrde kapsule
English: Table 1 Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 1-8)
Croatian: Tablica 1 Preporučeni raspored doziranja panobinostata u kombinaciji s bortezomibom i deksametazonom (1.-8. ciklus)
English: - if you have heart or heartbeat problems, such as irregular heartbeat or a condition called long
Croatian: - ako imate problema sa srcem ili otkucajima srca, kao što su neredoviti otkucaji ili stanje koje se naziva sindrom dugog QT-a. - ako imate bakterijsku, virusnu ili gljivičnu infekciju. - ako imate želučano-crijevne tegobe kao što su proljev, mučnina ili povraćanje.
English: grade ≤1 and resume treatment at a reduced dose.
Croatian: CTC-u - propustiti dozu do oporavka do ≤1. stupnja prema CTC-u te nastaviti liječenje u smanjenoj dozi.
English: The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
Croatian: Drugi sastojci su: magnezijev stearat, manitol, mikrokristalična celuloza, prethodno geliran škrob, želatina, titanijev dioksid (E171), crveni željezov oksid (E172), crni željezov oksid (E172), propilenglikol (E1520), glazura šelaka.
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 15 mg panobinostat.
Croatian: Svaka tvrda kapsula sadrži bezvodni panobinostatlaktat što odgovara 15 mg panobinostata.
English: Farydak 15 mg capsules panobinostat
Croatian: NAZIV LIJEKA Farydak 15 mg kapsule panobinostat
English: Farydak bortezomib and dexamethasone N=73
Croatian: Farydak bortezomib i deksametazon
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 20 mg panobinostat.
Croatian: Svaka tvrda kapsula sadrži bezvodni panobinostatlaktat što odgovara 20 mg panobinostata.
English: Titanium dioxide (E171) Brilliant blue FCF (E133) Iron oxide, yellow (E172)
Croatian: briljantno plava FCF (E133)
English: Table 2 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 9-16).
Croatian: Tablica 2 Preporučeni raspored uzimanja Farydaka u kombinaciji s bortezomibom i deksametazonom (9.-16. ciklus)
English: 95% CI [0.31; 0.72] Logrank p-value=0.0003
Croatian: + deksametazon [HR: 0,47 (0,31, 0,72)].
English: Farydak 20 mg hard capsules are red opaque capsules (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
Croatian: Farydak 20 mg tvrde kapsule su crvene neprozirne kapsule (19,1-19,7 mm) koje sadrže bijeli do gotovo bijeli prašak, s radijalnom oznakom „LBH 20 mg“ otisnutom crnom tintom na kapici i dvije radijalne pruge otisnute crnom tintom na tijelu, koje se isporučuju u blisterima.
English: Farydak 20 mg capsules panobinostat
Croatian: NAZIV LIJEKA Farydak 20 mg kapsule panobinostat
English: - if you are allergic to panobinostat or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete uzimati Farydak Nemojte uzimati Farydak: - ako ste alergični na panobinostat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako dojite.
English: Grade 4 neutropenia (<0.5 x 109/l) or febrile neutropenia (<1.0 x 109/l and fever ≥38.5°C)
Croatian: (<0,5 x 109/l) ili febrilna neutropenija
English: Farydak 10 mg hard capsules are light green opaque capsules (15.6-16.2 mm) containing white to almost white powder, with radial marking “LBH 10 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
Croatian: Farydak 10 mg tvrde kapsule su svijetlo zelene neprozirne kapsule (15,6-16,2 mm) koje sadrže bijeli do gotovo bijeli prašak, s radijalnom oznakom „LBH 10 mg“ otisnutom crnom tintom na kapici i dvije radijalne pruge otisnute crnom tintom na tijelu, koje se isporučuju u blisterima.
English: The median OS was 40.3 months in the panobinostat + bortezomib + dexamethasone arm and 35.8 months in the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.94 (95% CI: 0.78, 1.14)).
Croatian: + deksametazon (omjer hazarda: 0,94 (95% CI: 0,78, 1,14)).
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 10 mg panobinostat.
Croatian: Svaka tvrda kapsula sadrži bezvodni panobinostatlaktat što odgovara 10 mg panobinostata.
English: Table 2 Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 9-16)
Croatian: Tablica 2 Preporučeni raspored doziranja panobinostata u kombinaciji s bortezomibom i deksametazonom (9.-16. ciklus)
English: Farydak 15 mg hard capsules are orange opaque capsules (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 15 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
Croatian: Farydak 15 mg tvrde kapsule su narančaste neprozirne kapsule (19,1-19,7 mm) koje sadrže bijeli do gotovo bijeli prašak, s radijalnom oznakom „LBH 15 mg“ otisnutom crnom tintom na kapici i dvije radijalne pruge otisnute crnom tintom na tijelu, koje se isporučuju u blisterima.
English: Conjunctival haemorrhage
Croatian: Hemoragijski šok
English: Farydak 10 mg capsules panobinostat
Croatian: NAZIV LIJEKA Farydak 10 mg kapsule panobinostat
English: Farydak 15 mg hard capsules panobinostat
Croatian: NAZIV LIJEKA Farydak 15 mg tvrde kapsule panobinostat
English: - medicines that may have an unwanted effect on the heart (called QT prolongation), such as chloroquine, halofantrine, methadone, moxifloxacin, bepridil or pimozide.
Croatian: - lijekove koji bi mogli imati neželjeni učinak na srce (koji se zove produljenje QT-a), kao što su klorokin, halofantrin, metadon, moksifloksacin, bepridil ili pimozid. - lijekove koji se koriste za liječenje hipertenzije, kao što je metoprolol ili nebivolol. - lijekove koji se koriste za liječenje teških problema s mentalnim zdravljem, kao što je risperidon. - lijekove koji se koriste za liječenje raka dojke, kao što je tamoksifen. - lijekove koji se koriste za liječenje mučnine i povraćanja kao što su dolasetron, granisetron,
English: Any
Croatian: Dani
English: Red opaque hard gelatin capsule (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on cap and two radial bands in black ink on body.
Croatian: Crvena neprozirna tvrda želatinska kapsula (19,1-19,7 mm) koja sadrži bijeli do gotovo bijeli prašak, s radijalnom oznakom „LBH 20 mg“ otisnutom crnom tintom na kapici i dvije radijalne pruge otisnute crnom tintom na tijelu.
English: Grade 4 Platelets <25 x 109/l
Croatian: <25 x 109/l
English: Gastrointestinal disorders Very common Diarrhoea, nausea, vomiting, abdominal pain, dyspepsia
Croatian: Proljev, mučnina, povraćanje, bol u abdomenu, dispepsija
English: Farydak 20 mg hard capsules panobinostat
Croatian: NAZIV LIJEKA Farydak 20 mg tvrde kapsule panobinostat
English: Grade 3 neutropenia (<1.0-0.5 x 109/l)
Croatian: (<1,0-0,5 x 109/l)
English: Orange opaque hard gelatin capsule (19.1-19.7 mm) containing white to almost white powder, with radial marking “LBH 15 mg” in black ink on cap and two radial bands in black ink on body.
Croatian: Narančasta neprozirna tvrda želatinska kapsula (19,1-19,7 mm) koja sadrži bijeli do gotovo bijeli prašak, s radijalnom oznakom „LBH 15 mg“ otisnutom crnom tintom na kapici i dvije radijalne pruge otisnute crnom tintom na tijelu.
English: as per mEBMT criteria.
Croatian: nakon 8 ciklusa terapije prema kriterijima mEBMT-a.
English: Farydak 10 mg hard capsules panobinostat
Croatian: NAZIV LIJEKA Farydak 10 mg tvrde kapsule panobinostat
English: Bortezomib dose on recovery to grade 2 thrombocytopenia
Croatian: Doza bortezomiba nakon oporavka do trombocitopenije 2. stupnja (≥50 x 109/l) 1 doza propušte na
English: Haemorrhage
Croatian: Nesanica
English: Light green opaque hard gelatin capsule (15.6-16.2 mm) containing white to almost white powder, with radial marking “LBH 10 mg” in black ink on cap and two radial bands in black ink on body.
Croatian: Svijetlo zelena neprozirna tvrda želatinska kapsula (15,6-16,2 mm) koja sadrži bijeli do gotovo bijeli prašak, s radijalnom oznakom „LBH 10 mg“ otisnutom crnom tintom na kapici i dvije radijalne pruge otisnute crnom tintom na tijelu.
English: - atomoxetine, a medicine used to treat attention deficit hyperactivity disorder.
Croatian: ondansetron ili tropisetron; oni bi mogli imati i neželjeni učinak na srce (produljenje QT-a). - atomoksetin, lijek koji se koristi za liječenje poremećaja hiperaktivnosti i deficita pažnje.
English: Omit dose
Croatian: Propustiti dozu
English: SGOT (AST) levels
Croatian: Razine SGOT-a
English: • joint pain or inflammation
Croatian: • bol ili upala zglobova
English: What Farydak is and what it is used for What Farydak is
Croatian: Sadržaj pakiranja i druge informacije Što je Farydak i za što se koristi
English: EU/1/15/1023/004 6 capsules EU/1/15/1023/005 12 capsules EU/1/15/1023/006 24 capsules
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1023/004
English: Moderate >1.5 x ULN and ≤3.0 x ULN
Croatian: ≤3,0 x GGN
English: - Based on the recommendation of your doctor, the dose of Farydak is either 20 mg or 15 mg or
Croatian: • Na temelju preporuke Vašeg liječnika, doza Farydaka je ili 20 mg ili 15 mg ili 10 mg, a uzima se jedanput dnevno i to 1., 3., 5., 8., 10. i 12. dana 21-dnevnog ciklusa.
English: Day 2
Croatian: Dublin 2
English: Day 5
Croatian: Dodatku V.
English: Results showed that:
Croatian: Rezultati ispitivanja pokazali su sljedeće:
English: The recommended dose is 5 mg once a day.
Croatian: Preporučena doza je 5 mg jedanput na dan.
English: This summary was last updated in 06-2017.
Croatian: Sažetak je posljednji put ažuriran: 06.2017.
English: The full EPAR for Onglyza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Onglyza nalazi se na internetskim stranicama Agencije:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Regarding safety, Onglyza is generally well tolerated.
Croatian: U pogledu sigurnosti, Onglyza se općenito dobro podnosi.
English: Onglyza saxagliptin
Croatian: Onglyza saksagliptin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onglyza on 1 October 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Onglyza na snazi u Europskoj uniji od 1. listopada 2009.
English: This is a summary of the European public assessment report (EPAR) for Onglyza.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Onglyza.
English: The European Medicine Agency therefore decided that Onglyza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi lijeka Onglyza nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: What measures are being taken to ensure the safe and effective use of Onglyza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Onglyza?
English: What is Onglyza and what is it used for?
Croatian: Što je Onglyza i za što se koristi?
English: However, the results were not considered to be clinically relevant and the company withdrew its application for the use of saxagliptin as an initial combination medicine in previously untreated patients.
Croatian: Međutim, rezultati nisu smatrani klinički važnima i tvrtka je povukla svoj zahtjev za primjenu saksagliptina kao kombinacijskog lijeka u inicijalnom liječenju bolesnika koji nisu prethodno liječeni.
English: Onglyza is available as tablets (2.5 and 5 mg) and can only be obtained with a prescription.
Croatian: Lijek Onglyza dostupan je u obliku tableta (od 2,5 mg i 5 mg) i izdaje se samo na liječnički recept.
English: It works by blocking the breakdown of incretin hormones in the body.
Croatian: Djeluje inhibirajući razgradnju inkretinskih hormona u tijelu.
English: The dose of Onglyza should be reduced to 2.5 mg once a day in patients with moderate or severe kidney problems.
Croatian: Dozu lijeka Onglyza treba smanjiti na 2,5 mg jedanput na dan u bolesnika s umjerenim ili teškim oštećenjem funkcije bubrega.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onglyza 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 Onglyza nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: If used in combination with a sulphonylurea (medicines that make the body produce insulin) or insulin, the dose of these medicines may need to be reduced to avoid hypoglycaemia (low blood sugar levels).
Croatian: Ako se primjenjuje u kombinaciji sa sulfonilurejom (lijekovima koji tijelo potiču na stvaranje inzulina) ili inzulinom, dozu tih lijekova možda će trebati smanjiti kako bi se izbjegla pojava hipoglikemije (niske razine šećera u krvi).
English: It is not intended to provide practical advice on how to use Onglyza.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Onglyza.
English: Other information about Onglyza
Croatian: Ostale informacije o lijeku Onglyza
English: HbA1c levels were on average around 9% at the start of the study.
Croatian: Razine HbA1c iznosile su u prosjeku oko 9 % na početku ispitivanja.
English: The main measure of effectiveness was the reduction in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje razine glikoziliranog hemoglobina (HbA1c) u krvi nakon 24 tjedna liječenja.
English: Saxagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Croatian: Saksagliptin također smanjuje količinu glukoze koju proizvodi jetra tako što povećava razinu inzulina i snižava razinu hormona glukagona.
English: Onglyza must not be used in people who are hypersensitive (allergic) to saxagliptin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 inhibitor.
Croatian: Onglyza se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na saksagliptin ili bilo koji drugi sastojak lijeka ili u bolesnika koji su imali tešku alergijsku reakciju na bilo koji inhibitor DPP-4.
English: Saxagliptin does not work when the blood glucose is low.
Croatian: Saksagliptin ne djeluje ako su razine glukoze u krvi niske.
English: Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Croatian: Ti procesi zajedno snižavaju razinu glukoze u krvi i pomažu pri kontroli dijabetesa tipa 2.
English: It is used either on its own in patients who cannot take metformin (another diabetes medicine) or as ‘add-on' to other diabetes medicines, including insulin.
Croatian: Primjenjuje se kao monoterapija u bolesnika koji ne mogu uzimati metformin (drugi lijek protiv dijabetesa) ili kao „dodatak” drugim lijekovima protiv dijabetesa, uključujući inzulin.
English: The active substance in Onglyza, saxagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Croatian: Djelatna tvar u lijeku Onglyza, saksagliptin, inhibitor je dipeptidil peptidaze 4 (DPP-4).
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Croatian: Ti se hormoni otpuštaju nakon obroka i potiču gušteraču na proizvodnju inzulina.
English: HbA1c levels were around 8% at the start of the study.
Croatian: Razine HbA1c iznosile su oko 8 % na početku ispitivanja.
English: The most common side effects with Onglyza (seen in more than 5 patients in 100) are upper respiratory tract infection (nose and throat infection), urinary tract infection and headache.
Croatian: Najčešće nuspojave lijeka Onglyza (zabilježene u više od 5 na 100 bolesnika) su infekcija gornjeg dijela dišnog sustava (infekcije nosa i grla), infekcija mokraćnog sustava i glavobolja.
English: This gives an indication of how well the blood glucose is controlled.
Croatian: To pokazuje koliko se dobro kontrolira razina glukoze u krvi.
English: What are the risks associated with Onglyza?
Croatian: Koji su rizici povezani s lijekom Onglyza?
English: Adding dapagliflozin to metformin reduced HbA1c levels by 1.2 percentage points.
Croatian: Dodavanjem dapagliflozina metforminu razina HbA1c smanjena je za 1,2 postotna boda.
English: For more information about treatment with Onglyza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Onglyza pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.