FrancophonIA/ELRC3.0 huggingface dataset:
English: Empagliflozin 24 months data, as add-on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 3), and a clinically meaningful reduction in FPG, compared to glimepiride.
Croatian: U ispitivanju u kojem su uspoređivane djelotvornost i sigurnost empagliflozina 25 mg naspram glimepirida (do 4 mg na dan) u bolesnika s nezadovoljavajućom regulacijom glikemije na monoterapiji metforminom, svakodnevno liječenje empagliflozinom rezultiralo je superiornim sniženjem vrijednosti HbA1c (Tablica 3) te klinički značajnim sniženjem vrijednosti FPG u usporedbi s glimepiridom.
English: HbA1c <7% with baseline HbA1c ≥7% at week 52b, 2
Croatian: HbA1c ≥ 7 % u 52. tjednub, 2
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Croatian: Bolesnici (%) s postignutim HbA1c < 7 %
English: • muscular cramps
Croatian: • grčevi u mišićima
English: For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin In patients not adequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin, the recommended starting dose of Synjardy should provide empagliflozin 5 mg twice daily (10 mg daily dose) and the dose of metformin similar to the dose already being taken.
Croatian: U bolesnika u kojih nije postignuta zadovoljavajuća regulacija uz metformin kao monoterapiju ili u kombinaciji s drugim lijekovima za snižavanje glukoze u krvi, uključujući inzulin, preporučena početna doza lijeka Synjardy mora osigurati 5 mg empagliflozina dvaput dnevno (dnevna doza 10 mg)
English: • feeling sick (nausea), vomiting
Croatian: Vrlo često • mučnina, povraćanje
English: This medicinal product must not be used in patients with moderate or severe renal impairment (creatinine clearance <60 ml/min) (see sections 4.3 and 4.4).
Croatian: Lijek se ne smije primjenjivati u bolesnika s umjerenim ili teškim oštećenjem bubrega (klirens kreatinina < 60 ml/min.)
English: • if you need to have an injection of contrast agent that contains iodine, for example before an X-ray or scan.
Croatian: Vaš liječnik može zatražiti prekid primjene lijeka Synjardy sve dok se ne oporavite; • ako trebate primiti injekciju kontrastnog sredstva koje sadrži jod, na primjer prije rendgenskog snimanja ili skeniranja.
English: The efficacy and safety of empagliflozin as add on to basal insulin with concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Croatian: Djelotvornost i sigurnost empagliflozina kao dodatka bazalnom inzulinu s istodobnom terapijom metforminom ocjenjivane su u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od
English: N HbA1c (%) at week 18a
Croatian: N HbA1c (%) u 18. tjednu
English: Completers using last observation carried forward (LOCF) prior to glycaemic rescue therapy 1 mean adjusted for baseline value
Croatian: last observation carried forward, LOCF) prije primjene pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue)
English: 2 not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial <100 mg/dl (5.5 mmol/l), post-prandial <140 mg/dl (7.8 mmol/l) * p-value ≤0.0005
Croatian: 3 19. - 40. tjedan režima liječenja usmjerenog ka cilju (engl. treat-to-target) za prilagođavanje doze inzulina kako bi se postigle prethodno definirane ciljne razine glukoze u krvi ( < 100 mg/dl (5,5 mmol/l) preprandijalno, < 140 mg/dl (7,8 mmol/l) postprandijalno) ** p-vrijednost ≤ 0,0005 ** p-vrijednost < 0,005
English: * p-value <0.0001 ** p-value <0.01
Croatian: * p-vrijednost < 0,0001 ** p-vrijednost < 0,001
English: Major hypoglycaemia (hypoglycaemia requiring assistance) The frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin.
Croatian: Učestalost bolesnika s događajima teške hipoglikemije bila je niska (< 1 %) i slična uz empagliflozin i placeb kao dodatkom metforminu.
English: Inhibition of OATP1B1/1B3 transporters by co-administration with rifampicin resulted in a 75% increase in Cmax and a 35% increase in AUC of empagliflozin.
Croatian: Inhibicija prijenosnika OATP1B1/1B3 putem istodobne primjene s rifampicinom rezultirala je 75 %
English: • a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017,
Croatian: metformin 7,5 događaja/1000 bolesnik-godina, samo režim prehrane 12,7 događaja/1000 bolesnik-godina, p= 0,017.
English: Hypoglycaemia The frequency of hypoglycaemia depended on the background therapy in the respective studies.
Croatian: Učestalost hipoglikemije ovisila je o osnovnom liječenju u odgovarajućim ispitivanjima.
English: N HbA1c (%) at week 52b
Croatian: HbA1c (%) u 52. tjednub
English: 2 Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 LOCF, values after antihypertensive rescue censored
Croatian: 1 Srednja vrijednost prilagođena za početnu vrijednost 2 Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde 3 LOCF, cenzurirane vrijednosti nakon dodavanja terapije za postizanje zadovoljavajućeg krvnog tlaka
English: SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys.
Croatian: (šećera u krvi) putem mokraće tako što apsorbira glukozu u krvotok dok se krv filtrira u bubrezima.
English: It is important to stay on the diet and exercise program recommended by your doctor while taking Synjardy.
Croatian: Važno je, tijekom uzimanja lijeka Synjardy, pridržavati se režima prehrane i provoditi tjelovježbu prema preporuci
English: ketoacidosisa, b Lactic acidosis3
Croatian: Dijabetička ketoacidoza a, b
English: As expected, empagliflozin 5 mg administered twice daily compared with 10 mg empagliflozin once daily resulted in lower Cmax and higher trough plasma empagliflozin concentrations (Cmin).
Croatian: Kao što se pretpostavljalo, empagliflozin 5 mg primijenjen dvaput dnevno u usporedbi s empagliflozinom 10 mg primijenjenim jedanput dnevno rezultirao je nižim vrijednostima
English: • feeling or being very sick
Croatian: • mučnina ili jako povraćanje
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Croatian: Ispitivanja interakcija provedena na zdravim dobrovoljcima sugeriraju da empagliflozin nije imao klinički značajan učinak na farmakokinetiku metformina, glimepirida, pioglitazona, sitagliptina,
English: (97.5% CI) a Subgroup analysis for patients on additional background of metformin (FAS, LOCF) b Subgroup analysis for patients on additional background of metformin (PPS-Completers, LOCF) 1 Mean adjusted for baseline value
Croatian: Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5 % CI) a Analiza podskupine u bolesnika na dodatnoj osnovnoj terapiji metforminom (FAS, LOCF) b Analiza podskupine u bolesnika na dodatnoj osnovnoj terapiji metforminom (bolesnici koji su završili ispitivanje po protokolu, LOCF)
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Croatian: Dijagnostički laboratorijski nalazi su snižena pH vrijednost u krvi, razina laktata u plazmi iznad
English: • reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis,
Croatian: Metformin može djelovati putem triju mehanizama: • smanjenjem proizvodnje glukoze u jetri inhibicijom glukoneogeneze i glikogenolize,
English: Lactic acidosis.
Croatian: Laktacidoza.
English: The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps, digestive disorders as abdominal pain and severe asthenia.
Croatian: Rizik od laktacidoze mora se uzeti u obzir kod nespecifičnih znakova poput grčeva u mišićima,
English: As expected from the mechanism of action, increased urination (as assessed by PT search including pollakiuria, polyuria, nocturia) was observed at higher frequencies in metformin-treated patients who received empagliflozin 10 mg (3.0%) and empagliflozin 25 mg (2.9%) compared to placebo (1.4%) as add-on to metformin therapy.
Croatian: (pretragom preporučenih izraza uključujući polakizuriju, poliuriju i nokturiju) u bolesnika liječenih metforminom koji su primali empagliflozin 10 mg (3,0 %) i empagliflozin 25 mg (2,9 %) u usporedbi s placebom (1,4 %) kao dodatkom terapiji metforminom.
English: Co-administration of empagliflozin with probenecid, an inhibitor of UGT enzymes and OAT3, resulted in a 26% increase in peak empagliflozin plasma concentrations (Cmax) and a 53% increase in area under the concentration-time curve (AUC).
Croatian: rezultirala je 26 %-tnim povećanjem vršne koncentracije empagliflozina u plazmi (Cmax) i 53 %-tnim povećanjem površine ispod krivulje koncentracija-vrijeme (AUC).
English: An embryofetal development study in pregnant rats did not indicate a teratogenic effect attributed to the co-administration of empagliflozin and metformin at exposures of approximately 14-times the clinical AUC exposure of empagliflozin associated with the highest dose, and 4-times the clinical AUC exposure of metformin associated with the 2000 mg dose.
Croatian: Ispitivanje embrio-fetalnog razvoja u skotnih štakora nije ukazalo na teratogene učinke pripisane istodobnoj primjeni empagliflozina i metformina pri izloženosti približno 14 puta većoj od kliničke
English: 2 Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 3 LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored
Croatian: 3 LOCF, cenzurirane vrijednosti nakon uzimanja pomoćne antidijabetičke terapije (engl. antidiabetic rescue therapy) ili promjene pomoćne antihipertenzivne terapije (engl. antihypertensive rescue therapy)
English: Uncommon • straining or pain when emptying the bladder
Croatian: • naprezanje ili bol kod pražnjenja mjehura Vrlo rijetko
English: During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Croatian: Tijekom početnih 18 tjedana i posljednjih 12 tjedana doza inzulina je bila stalna, ali se između 19. i 40. tjedna prilagođavala u cilju postizanja razine glukoze < 100 mg/dl
English: 10 mg or 25 mg as add-on to metformin resulted in statistically significant reductions in HbA1c at Week 24 (adjusted mean change from baseline of -1.49% for empagliflozin 25 mg, -1.40% for empagliflozin 10 mg, and -0.44% for placebo).
Croatian: U prethodno specificiranoj analizi ispitanika s početnom vrijednošću HbA1c ≥ 9,0 % liječenje empagliflozinom 10 mg ili 25 mg kao dodatkom metforminu rezultiralo je statistički značajnim sniženjima vrijednosti HbA1c u 24. tjednu (prilagođena srednja promjena u odnosu na početnu vrijednost u iznosu od -1,49 % za empagliflozin od 25 mg, -1,40 % za empagliflozin od 10 mg te -0,44 % za placebo).
English: • diarrhoea or stomach ache
Croatian: • proljev ili bol u trbuhu • gubitak teka
English: • a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021),
Croatian: 20,6 događaja/1000 bolesnik-godina (p= 0,011) te naspram skupina liječenih kombinacijom sa sulfonilurejom i inzulinom u monoterapiji 18,9 događaja/1000 bolesnik-godina (p= 0,021),
English: (97.5% CI) N Basal insulin dose (IU/day) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1
Croatian: Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5 % CI) N Doza bazalnog inzulina (IU/dan) u 78. tjednu
English: Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1
Croatian: Početna vrijednost (prosječna) Promjena od početne vrijednosti4 Razlika od placeba4
English: Hepatic injury
Croatian: Hepatitis3
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Dijabetička ketoacidoza, dijabetička pretkoma.
English: N HbA1c (%) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2 N Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N SBP (mmHg)2 Baseline (mean) Change from baseline1 Difference from placebo1 (95% CI)
Croatian: Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5 % CI) N Bolesnici (%) s postignutim HbA1c < 7 %
English: How to store Synjardy 6.
Croatian: Moguće nuspojave 5. Kako čuvati Synjardy
English: • a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Croatian: 11 događaja/1000 bolesnik-godina, samo režim prehrane 18 događaja/1000 bolesnik-godina (p= 0,01).
English: • vomiting, stomach ache
Croatian: • povraćanje, bol u trbuhu
English: • redness of the skin (erythema) or an itchy rash (hives)
Croatian: • crvenilo kože (eritem) ili osip koji svrbi (koprivnjača) Prijavljivanje nuspojava
English: HbA1c of <7% compared to linagliptin 5 mg. Clinically meaningful reductions in HbA1c were maintained for 52 weeks.
Croatian: Klinički značajna smanjenja vrijednosti HbA1c održana su tijekom 52 tjedna.
English: A greater proportion of patients with a baseline HbA1c ≥7.0% and treated with empagliflozin plus linagliptin achieved a target
Croatian: Veći udio bolesnika s početnom vrijednošću HbA1c ≥ 7,0 % , koji su liječeni kombinacijom empagliflozin plus linagliptin, postigli su ciljnu vrijednost HbA1c < 7 % u usporedbi s linagliptinom 5 mg.
English: (95% CI)2
Croatian: Razlika od placeba1 (95 % CI)2
English: b, 3
Croatian: CI) N
English: (95% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy bSubgroup analysis for patients on additional background of metformin (FAS, LOCF) 1 Mean adjusted for baseline value
Croatian: Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5 % CI) a Analiza podskupina iz potpunog skupa za analizu (engl. full analysis set, FAS) u bolesnika na dodatnoj osnovnoj terapiji metforminom - ispitanici koji su završili ispitivanje s prenošenjem posljednjih opažanja dalje (engl. last observation carried forward, LOCF) prije primjene pomoćne terapije za postizanje zadovoljavajuće glikemije (engl. glycaemic rescue) 1 Srednja vrijednost prilagođena za početnu vrijednost
English: Patients with baseline HbA1c ≥9% In a pre-specified analysis of subjects with baseline HbA1c ≥9.0%, treatment with empagliflozin
Croatian: Bolesnici s početnom vrijednošću HbA1c ≥ 9 %
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Croatian: Svaka tableta sadrži 5 mg empagliflozina i 850 mg metforminklorida.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Croatian: Svaka tableta sadrži 12,5 mg empagliflozina i 850 mg metforminklorida.
English: At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in body weight.
Croatian: HbA1c i uštedom inzulina u usporedbi s placebom te sniženjem tjelesne težine.
English: The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) in metformin-treated patients who received empagliflozin was low: 0.6% for empagliflozin 10 mg, 0.3% for empagliflozin 25 mg and 0.1% for placebo.
Croatian: ortostatske hipotenzije i sinkope) bila je niska u bolesnika liječenih metforminom koji su primali empagliflozin: 0,6 % za empagliflozin 10 mg, 0,3 % za empagliflozin 25 mg i 0,1 % za placebo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Croatian: Svaka tableta sadrži 12,5 mg empagliflozina i 1000 mg metforminklorida.
English: Based on the mode of action of SGLT2 inhibitors, osmotic diuresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure (see section 5.1).
Croatian: Na temelju načina djelovanja inhibitora SGLT2, osmotska diureza, koja prati terapijsku glukozuriju,
English: SBP (mmHg)2, 3
Croatian: Sistolički krvni tlak (mmHg)2, 3 Početna vrijednost (prosječna)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Croatian: Svaka tableta sadrži 5 mg empagliflozina i 1000 mg metforminklorida.
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'): - 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: - 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: Empagliflozin and metformin
Croatian: Empagliflozin i linagliptin kao dodatna terapija metforminu
English: 4 Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001
Croatian: 2 Srednja vrijednost prilagođena za početnu vrijednost HbA1c, početnu vrijednost eGFR, zemljopisno područje i broj antihipertenzivnih lijekova
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Synjardy 5 mg/850 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Croatian: Synjardy 5 mg/850 mg filmom obložene tablete Svaka tableta sadrži 5 mg empagliflozina i 850 mg metforminklorida.
English: At dose levels of 500 mg/kg/day administered to Wistar Hannover rats, associated with 7-times the maximum recommended human dose (MRHD) of metformin, teratogenicity of metformin was observed, mostly evident as an increase in the number of skeletal malformations.
Croatian: Teratogenost metformina, koja se većinom očitovala kao povećanje broja malformacija skeleta, bila je opažena u štakora soja Wistar Hannover pri dozama od 500 mg/kg/dan,
English: Body Weight (kg) at week 52b
Croatian: Doza inzulina (IU/dan) u 52. tjednub, 3
English: Your kidneys will be tested by a blood test before you start taking and while you are taking this medicine.
Croatian: Prije nego počnete uzimati ovaj lijek i tijekom njegovog uzimanja, Vaši bubrezi će biti kontrolirani pomoću krvnih pretraga.
English: Maize starch
Croatian: bikonveksne.
English: There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance (see section 4.4)).
Croatian: pothranjenosti ili oštećenja jetre zbog djelatne tvari metformina (vidjeti dio 4.4.)).
English: Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm).
Croatian: Boehringer Ingelheim utisnutima na jednoj te oznakom „1000“ na drugoj strani (duljina tablete: 21,1 mm, širina tablete: 9,7 mm).
English: Baseline (mean) Change from baseline1 Difference from placebo1
Croatian: Promjena od početne vrijednosti1 Razlika od placeba1 (95 %
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1
Croatian: Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5 %
English: Boehringer Ingelheim spol.
Croatian: Boehringer Ingelheim Ltd.
English: Baseline (mean) Change from baseline5
Croatian: Početna vrijednost (prosječna) Promjena od početne vrijednosti5
English: Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex.
Croatian: Synjardy 12,5 mg/1000 mg filmom obložene tablete su tamnosmećkasto ljubičaste, ovalne,
English: 1 Bottle
Croatian: 1 boca
English: 200 mg (1 mg/ml) after reconstitution
Croatian: 200 mg (1 mg/ml) nakon rekonstitucije
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Croatian: Doza Farmaceutski oblik Put primjene Pakovanje
English: 200 mg Powder for oral solution Oral use
Croatian: 200mg Prašak za oralnu otopinu
English: EMEA 2006
Croatian: Zaštićeno ime
English: Bottle (HDPE) 14 capsules
Croatian: Bočica (HDPE) 14 kapsula
English: 20 mg Gastro-resistant capsule, hard
Croatian: 20 mg Želučanootporna tvrda kapsula
English: (Invented) name Strength Pharmaceutical form Route of administration
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Both co-primary objectives were met:
Croatian: Oba su primarna cilja bila postignuta:
English: • or through an evaluation of individual case reports.
Croatian: ● ili ocjenom izvješća o pojedinačnim slučajevima.
English: If indicated, therapy should either be permanently discontinued or temporarily suspended as described in section 4.4.
Croatian: Ako je indicirano, liječenje je potrebno ili trajno obustaviti ili privremeno prekinuti, kako je opisano u dijelu 4.4.
English: • epidemiological studies\non-interventional or observational studies,
Croatian: ● iz epidemioloških ispitivanja odnosno neintervencijskih ili opservacijskih ispitivanja
English: There were no objective (partial or complete) radiological responses (MacDonald criteria).
Croatian: Nije bilo objektivnih (djelomičnih ili potpunih) radioloških odgovora (kriterij prema MacDonaldu).
English: The incidence varied between 10% (4/40) and 20% (3/15).
Croatian: Incidencija je varirala između 10 % (4/40) i 20 % (3/15).
English: Objective response rate was low in both treatment arms and the difference was not significant.
Croatian: Stopa objektivnog odgovora bila je niska u obje terapijske skupine, a razlika nije bila značajna.
English: If you are considering having children you should discuss this with your doctor before your treatment starts.
Croatian: Ako namjeravate imati djecu, o tome razgovarajte sa svojim liječnikom prije nego započnete liječenje.
English: • spontaneous reporting,
Croatian: ● iz spontanih prijava,
English: Efficacy results for study ML18147 (ITT population)
Croatian: Rezultati djelotvornosti za ispitivanje ML18147 (ITT populacija)