FrancophonIA/ELRC3.0 huggingface dataset:
English: Subjects were randomised in a 1:2 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Croatian: Ispitanici su bili randomizirani u omjeru 1:2 za primanje lijekova Exviera i ombitasvir/paritaprevir/ritonavir, u kombinaciji s ribavirinom ili bez njega, tijekom 12 tjedana liječenja.
English: Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily
Croatian: 200 mg jedanput na dan/ 300 mg jedanput na dan
English: ↔ ethinyl estradiol
Croatian: KG Knollstrasse
English: Table 8 shows the SVR12 rates for genotype 1b-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL III.
Croatian: Tablici 8 prikazane su stope SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1b koji su primali lijekove Exviera i ombitasvir/paritaprevir/ritonavir, s ribavirinom ili bez njega, tijekom 12 tjedana u ispitivanju PEARL III.
English: ANTIDEPRESSANTS Escitalopram 10 mg single dose
Croatian: Escitalopra m10 mg pojedinačna doza
English: If clinically indicated, higher doses of esomeprazole/lansopraz ole may be needed.
Croatian: Mogu biti potrebne veće doze esomeprazola/lanzoprazo la, ako je to klinički indicirano.
English: SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatment-naïve or previously treated with pegIFN/RBV
Croatian: Tablica 12. SVR12 za ispitanike s infekcijom genotipom 1 i kompenziranom cirozom koji prethodno nisu bili liječeni ili su primali pegIFN/RBV Ishod liječenja
English: TURQUOISE-II- genotype 1, treatment-naïve or peginterferon+ribavirin-experienced subjects with compensated cirrhosis
Croatian: TURQUOISE-II- ispitanici s infekcijom genotipom 1 i kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni peginterferonom i ribavirinom
English: PEARL-III was a randomised, global multicentre, double-blind, controlled trial conducted in 419 treatment-naïve adults with genotype 1b chronic hepatitis C virus infection without cirrhosis.
Croatian: PEARL-III - prethodno neliječeni ispitanici s infekcijom genotipom 1b PEARL-III bilo je randomizirano, globalno, multicentrično, dvostruko slijepo, kontrolirano ispitivanje provedeno u 419 prethodno neliječenih odraslih ispitanika s kroničnom infekcijom virusom hepatitisa C genotipa 1b bez ciroze.
English: No dose adjustment is necessary for raltegravir or Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za raltegravir ili Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Potential for other medicinal products to affect the pharmacokinetics of dasabuvir
Croatian: Mogući utjecaj drugih lijekova na farmakokinetiku dasabuvira Lijekovi koji inhibiraju CYP2C8
English: Exviera safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Croatian: Istodobna primjena s drugim antiviroticima koji djeluju izravno na HCV Ustanovljene su sigurnost i djelotvornost lijeka Exviera u kombinaciji s ombitasvirom/ paritaprevirom /ritonavirom, s ribavirinom ili bez njega.
English: When taking Exviera and ombitasvir/paritaprevir/ritonavir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - Feel sick (nauseous), are sick (vomit) or lose your appetite.
Croatian: Recite svom liječniku ako imate sljedeće simptome tijekom uzimanja lijeka Exviera i ombitasvira/paritaprevira/ritonavira jer oni mogu biti znakovi pogoršanja jetrenih tegoba:
English: Exviera and ombitasvir/paritaprevir/ritonavir (12 weeks)
Croatian: GT1b Exviera i ombitasvir/paritaprevir/ritonavir (12 tjedana)
English: Mechanism: P-gp inhibition by dasabuvir, paritaprevir, and ritonavir.
Croatian: Mehanizam: inhibicija Pgp-a koju uzrokuju dasabuvir, paritaprevir i ritonavir
English: Mechanism: CYP3A4 induction by St. John's Wort.
Croatian: Mehanizam: CYP3A4 indukcija gospinom travom
English: Exviera ombitas vir/parit aprevir/ ritonavi r atazanavir
Croatian: Exviera + ombitasvir/p aritaprevir/ri tonavir atazanavir
English: Interactions between Exviera with ombitasvir/paritaprevir/ritonavir and other medicinal products
Croatian: Tablica 2. Interakcije između lijeka Exviera s ombitasvirom/paritaprevirom/ritonavirom i drugih lijekova Lijek/mogu ći mehanizam interakcije
English: PEARL-IV was a randomised, global multicentre, double-blind, controlled trial conducted in 305 treatment-naïve adults with genotype 1a chronic hepatitis C virus infection without cirrhosis.
Croatian: PEARL-IV - prethodno neliječeni ispitanici s infekcijom genotipom 1a PEARL-IV bilo je randomizirano, globalno, multicentrično, dvostruko slijepo, kontrolirano ispitivanje provedeno u 305 prethodno neliječenih odraslih ispitanika s kroničnom infekcijom virusom hepatitisa
English: Table 11 shows the SVR12 rates for genotype 1b-infected, treatment-experienced subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL II.
Croatian: U Tablici 11 prikazane su stope SVR12 za prethodno liječene ispitanike s infekcijom genotipom 1b koji su primali lijekove Exviera i ombitasvir/paritaprevir/ritonavir, s ribavirinom ili bez njega, tijekom 12 tjedana u ispitivanju PEARL II.
English: Coadministration with ethinylestradiol may lead to increased risk of ALT elevations (see sections 4.3 and 4.4).
Croatian: Istodobna primjena s etinilestradiolom može povećati rizik od povišene razine ALT-a (vidjeti dijelove
English: Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders; and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; 21.8% had a body mass index of at least 30 kg/m2; 12.8% had a history of depression or bipolar disorder; 90.5% had IL28B non-CC genotype; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Croatian: Medijan dobi liječenih ispitanika (N=179) iznosio je 57 godina (raspon: 26 do 70); 35,2% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 28,5% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 36,3% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 54,2% ispitanika bili su muškarci; 3,9% bili su crnci; 21,8% imalo je indeks tjelesne mase od najmanje 30 kg/m2; 12,8% imalo je depresiju ili bipolarni poremećaj u anamnezi; 90,5% imalo je IL28B non-CC genotip; 87,7% imalo je početne razine HCV RNK od najmanje 800 000 IU/ml; 17,9% imalo je portalnu fibrozu (F2), a 14,0%
English: TURQUOISE-III: Clinical Trial of GT1b-Infected Subjects with Cirrhosis without RBV
Croatian: Kliničko ispitivanje provedeno u ispitanika s infekcijom genotipom 1b i cirozom bez ribavirina
English: Medicinal products transported by Pgp in the intestine While dasabuvir is an in vitro inhibitor of P-gp, no significant change was observed in the exposure of the P-gp substrate, digoxin, when administered with Exviera with ombitasvir/paritaprevir/ritonavir.
Croatian: Iako je dasabuvir in vitro inhibitor P-gp-a, nije primijećena značajna promjena izloženosti digoksinu,
English: trimethopri m
Croatian: Teriflunomi d
English: Exviera contains lactose.
Croatian: Sadrži i laktozu.
English: Lopinavir/ritonavir 400/100 mg twice daily or 800/200 mg once daily is contraindicated dasabuvir
Croatian: Lopinavir/ritonavir 400/100 mg dvaput na dan ili 800/200 mg jednaput na dan je kontraindiciran u s dasabuvirom i ombitasvirom/paritaprevi rom/ritonavirom zbog povišenja izloženosti paritapreviru (vidjeti Sažetak opisa svojstava lijeka ombitasvir/paritaprevir/ri tonavir ).
English: Digoxin 0.5 mg single dose
Croatian: Alprazolam 0,5 mg pojedinačna doza
English: Lansoprazole
Croatian: ANTIKOAGULANSI
English: CYP3A4 inhibition by ritonavir and increase in paritaprevir exposures may be due to
Croatian: Učinak na ciklosporin posljedica je inhibicije CYP3A4 ritonavirom, dok bi povećanje izloženosti paritaprevir u moglo biti posljedica inhibicije OATPa/BCRPa/P-gp-a uzrokovane primjenom ciklosporina
English: NAME OF THE MARKETING AUTHORISATION HOLDER AbbVie Ltd
Croatian: Nositelj odobrenja za stavljanje lijeka u promet AbbVie
English: Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 28.4% had a body mass index of at least 30 kg/m2; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 81.8% had IL28B non-CC genotype; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Croatian: Medijan dobi liječenih ispitanika (N=380) iznosio je 58 godina (raspon: 21 do 71); 42,1% prethodno nije bilo liječeno; 36,1% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 8,2% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 13,7% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 70,3% ispitanika bili su muškarci; 3,2% bili su crnci; 28,4% imalo je indeks tjelesne mase od najmanje 30 kg/m2; 14,7% imalo je broj trombocita manji od 90 x 109/l, 49,7% imalo je razinu albumina manju od 40 g/l; 86,1% imalo je početne razine HCV RNK od najmanje 800 000 IU po ml; 81,8% imalo je IL28B non-CC genotip;
English: The efficacy of dasabuvir has not been established in patients with HCV genotypes other than genotype 1; Exviera should not be used for the treatment of patients infected with other genotypes than
Croatian: Exviera se ne smije primjenjivati za liječenje bolesnika koji su zaraženi bilo kojim drugim genotipom osim genotipom 1.
English: No dose adjustment needed for Exviera + ombitasvir/paritaprevir/
Croatian: Exviera + ombitasvir/paritaprevir/
English: The mean EC50 of dasabuvir against replicons containingNS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
Croatian: U testu replikona HCV-a u staničnoj kulturi, srednja vrijednost EC50 dasabuvira protiv replikona koji sadrže NS5B iz palete izolata genotipa 1a odnosno 1b prikupljenih u prethodno neliječenih ispitanika iznosila je 0,77 nM
English: Exviera ombitas vir/parit aprevir/r itonavir rosuvastatin
Croatian: Exviera + ombitasvir/p aritaprevir/ri tonavir rosuvastatin
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 19.8% had a body mass index of at least 30 kg/m2; 20.6% had a history of depression or bipolar disorder; 89.6% had IL28B non-CC genotype; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Croatian: Medijan dobi liječenih ispitanika (N=394) iznosio je 54 godine (raspon: 19 do 71); 49,0% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 21,8% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 29,2% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 57,6% ispitanika bili su muškarci; 8,1% bili su crnci; 19,8% imalo je indeks tjelesne mase od najmanje 30 kg/m2; 20,6% imalo je depresiju ili bipolarni poremećaj u anamnezi; 89,6% imalo je IL28B non-CC genotip; 87,1% imalo je početnu razinu HCV RNK od najmanje 800 000 IU po ml; 17,8% imalo je portalnu fibrozu (F2), a 14,5%
English: Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Croatian: Ne preporučuje se primjena lijeka Exviera u bolesnika s umjerenim oštećenjem funkcije jetre (Child
English: Rosuvastatin
Croatian: Pravastatin
English: 24 weeks (see section 5.1.)
Croatian: (vidjetio dio 4.5).
English: No dose adjustment needed for dolutegravir when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu dolutegravira kada se primjenjuje s lijekovima Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Exviera with ombitasvir/paritaprevir/ritonavir with and without ribavirin.
Croatian: paritaprevirom /ritonavirom te u kombinaciji s ribavirinom ili bez njega prijavljeni su dekompenzacija jetre i zatajenje jetre, uključujući slučajeve koji su završili presađivanjem jetre ili smrtnim ishodom.
English: Hepatobiliary Disorders: Hepatic decompensation, hepatic failure have been observed during treatment with Exviera with ombitasvir/paritaprevir/ritonavir, with or without ribavirin (see section 4.4).
Croatian: Exviera u kombinaciji s ombitasvirom/paritaprevirom/ritonavirom i u kombinaciji s ribavirinom ili bez njega (vidjeti dio 4.4).
English: buprenorphin e/ naloxone 4-24 mg/16 mg once daily
Croatian: 4-24 mg/1-6 mg jedanput na dan
English: S-warfarin dasabuvir ombitasvir
Croatian: S-varfarin dasabuvir ombitasvir paritaprevir
English: NA No dose adjustment needed for abacavir or lamivudine when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: NP Nije potrebno prilagođavati dozu abakavira ili lamivudina kada se primjenjuju s lijekovima Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Darunavir/ ritonavir 600/100 mg twice daily
Croatian: ANTIMIKOTICI Ketokonazol 400 mg jednaput na dan
English: No dose adjustment is necessary for norethindrone or Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za kombinaciju noretindrona ili lijeka Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Exviera ombitas vir/parit aprevir/ ritonavi r duloxetine
Croatian: Exviera + ombitasvir/p aritaprevir/ri tonavir duloksetin
English: CYP3A by atazanavir and CYP3A inhibition by the additional dose of ritonavir.
Croatian: povećanje izloženosti paritaprevir u moglo bi biti posljedica inhibicije OATP1B1/ B3 i CYP3A koju uzrokuje atazanavir i inhibicije CYP3A koju uzrokuje dodatna doza ritonavira.
English: Hepatic impairment
Croatian: MIŠIĆNI RELAKSANSI
English: NA No dose adjustment is necessary for paracetamol when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: NP Nije potrebno prilagođavati dozu za paracetamol kada se primjenjuje s lijekovima Exviera + ombitasvir/paritaprevir/ri tonavir.
English: For contra-indications with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Croatian: Za kontraindikacije ombitasvira/ paritaprevira /ritonavira vidjeti njihov Sažetak opisa svojstava lijeka.
English: Film-coating
Croatian: DIURETICI Furosemid
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV 12-week arm
Croatian: Exviera i ombitasvir/paritaprevir/ritonavir s RBV-om
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
Croatian: skupina A: Exviera i ombitasvir/paritaprevir/ritonavir + RBV (12 tjedana) skupina B: Exviera i ombitasvir/paritaprevir/ritonavir + RBV (24 tjedna)
English: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets dasabuvir
Croatian: Uputa o lijeku: Informacija za bolesnika Exviera 250 mg filmom obložene tablete dasabuvir
English: Gastrointestinal disorders Very common
Croatian: Poremećaji probavnog sustava vrlo često mučnina
English: HCV ANTIVIRAL Sofosbuvir
Croatian: Sofosbuvir
English: • Itching.
Croatian: • svrbež.
English: Exviera + ombitasvir/paritaprevir/ ritonavir may increase the plasma concentrations of dabigatran etexilate.
Croatian: ritonavir može povećati koncentracije dabigatran eteksilata u plazmi.
English: Exviera ombitas vir/parit aprevir/ ritonavi r ciclosporin
Croatian: Exviera + ombitasvir/p aritaprevir/ri tonavir ciklosporin
English: For interactions with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Croatian: Za interakcije s ombitasvirom/ paritaprevirom/ritonavirom vidjeti Sažetak opisa svojstava lijeka.
English: Clinical trials in peginterferon+ribavirin-experienced adults
Croatian: Klinička ispitivanja u odraslih ispitanika prethodno liječenih kombinacijom peginterferon+ribavirin SAPPHIRE-II -ispitanici s infekcijom genotipom 1 prethodno liječeni kombinacijom peginterferon+ribavirin
English: Exviera ombitas vir/parit aprevir/r itonavir cyclobenzap rine
Croatian: ombitasvir/par itaprevir/riton avir ciklobenzapr in
English: Clinical Comments possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Croatian: Mehanizam: mogao bi biti posljedica inhbicije UGT1A1 koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
English: No dose adjustment is necessary for buprenorphine/naloxon e and Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za buprenorfin/nalokson i Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Croatian: HCV genotipa 1b Exviera i ombitasvir/paritaprevir/ritonavir
English: NA No dose adjustment needed for sofosbuvir when administered with Exviera + ombitasvir/paritaprevir /ritonavir.
Croatian: NP Nije potrebno prilagođavati dozu sofosbuvira kada se primjenjuje s lijekovima Exviera + ombitasvir/paritaprevir/ri tonavir.
English: The recommended dose is one tablet taken once a day.
Croatian: Preporučena doza je jedna tableta jedanput na dan.
English: The full EPAR for Qtern can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Qtern nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Qtern
Croatian: Ostale informacije o lijeku Qtern
English: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Croatian: Dapagliflozin je odobren u Europskoj uniji (EU) pod nazivom Forxiga od 2012.;
English: Qtern contains two different active substances, which work in different ways:
Croatian: Lijek Qtern sadrži dvije različite djelatne tvari koje različito djeluju:
English: What measures are being taken to ensure the safe and effective use of Qtern?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Qtern?
English: What is Qtern and what is it used for?
Croatian: Što je Qtern i za što se koristi?
English: It is not intended to provide practical advice on how to use Qtern.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Qtern.
English: This is a summary of the European public assessment report (EPAR) for Qtern.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Qtern.
English: Qtern saxagliptin / dapagliflozin
Croatian: Qtern saksagliptin/dapagliflozin
English: What are the risks associated with Qtern?
Croatian: Koji su rizici povezani s lijekom Qtern?
English: Saxagliptin has been authorised in the EU as Onglyza since 2009.
Croatian: Saksagliptin je odobren u Europskoj uniji (EU) pod nazivom Onglyza od 2009.
English: • saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Croatian: • saksagliptin je inhibitor dipeptidil peptidaze 4 (DPP-4).
English: The CHMP therefore considered that Qtern should only be used in patients already receiving at least one component to avoid over-treatment and so that the value of each component can be judged individually.
Croatian: CHMP je stoga zaključio da bi se lijek Qtern trebao primjenjivati samo u bolesnika koji već primaju najmanje jednu od tih sastavnica kako bi se izbjeglo prekomjerno liječenje i kako bi se vrijednost svake sastavnice mogla prosuđivati pojedinačno.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qtern 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 Qtern nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Qtern's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Qtern nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Why is Qtern approved?
Croatian: Zašto je lijek Qtern odobren?
English: The most common side effects with Qtern (which may affect more than 1 in 10 people) are upper respiratory tract infection (such as nose and throat infections) and, when used with a sulphonylurea, hypoglycaemia (low blood glucose levels).
Croatian: Najčešće su nuspojave lijeka Qtern (mogu se javiti u više od 1 na 10 osoba) infekcije gornjeg respiratornog trakta (kao što su infekcije nosa ili grla) i, kada se primjenjuje sa sulfonilurejom, hipoglikemija (niska razina glukoze u krvi).
English: It works by blocking the breakdown of incretin hormones in the body.
Croatian: Djeluje tako da onemogućuje razgradnju „inkretinskih” hormona u tijelu.
English: Although both components of Qtern contribute to lowering blood glucose levels, the effects of each may vary in different patients.
Croatian: Iako obje sastavnice lijeka Qtern doprinose smanjenju razine glukoze u krvi, učinci svake pojedinačno mogu se razlikovati kod različitih bolesnika.
English: Qtern must not be used in people who are hypersensitive (allergic) to saxagliptin, dapagliflozin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.
Croatian: Lijek Qtern ne smije se primjenjivati u bolesnika koji su preosjetljivi (alergični) na saksagliptin, dapagliflozin ili bilo koji drugi sastojak lijeka ili u bolesnika koji su imali teške alergijske reakcije na bilo koji inhibitor DPP-4 ili SGLT2.
English: On the basis of previous studies with the individual components of Qtern used together with a sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.
Croatian: Na osnovi prethodnih ispitivanja djelovanja pojedinačnih sastavnica lijeka Qtern zajedno sa sulfonilurejom, CHMP je odobrio i kombinaciju lijeka Qtern sa sulfonilurejom.
English: The main measure of effectiveness was the change after 24 weeks of treatment in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Croatian: Glavna mjera djelotvornosti bila je promjena u razini tvari u krvi koja se naziva glikozilirani hemoglobin (HbA1c) nakon 24 tjedna liječenja, što ukazuje na uspješnost kontrole glukoze u krvi.
English: Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with a prescription.
Croatian: Lijek Qtern dostupan je u obliku tableta (koje sadrže 5 mg saksagliptina i 10 mg dapagliflozina) i izdaje se samo na liječnički recept.
English: Saxagliptin does not work when the blood glucose is low.
Croatian: Saksagliptin ne djeluje ako je razina glukoze u krvi niska.
English: What benefits of Qtern have been shown in studies?
Croatian: Koje su koristi lijeka Qtern utvrđene u ispitivanjima?
English: For more information about treatment with Qtern, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Qtern pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.