FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Synjardy 5 mg/850 mg
Slovak: BLUE BOXU - 5 mg/850 mg
English: Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Slovak: Rozdiel oproti placebu (97,5
English: Synjardy 5 mg/850 mg film-coated tablets Synjardy 5 mg/1,000 mg film-coated tablets Synjardy 12.5 mg/850 mg film-coated tablets Synjardy 12.5 mg/1,000 mg film-coated tablets
Slovak: Synjardy 5 mg/850 mg filmom obalené tablety Synjardy 5 mg/1000 mg filmom obalené tablety Synjardy 12,5 mg/850 mg filmom obalené tablety Synjardy 12,5 mg/1000 mg filmom obalené tablety
English: Synjardy 5 mg/850 mg film-coated tablets Synjardy 5 mg/1,000 mg film-coated tablets Synjardy 12.5 mg/850 mg film-coated tablets Synjardy 12.5 mg/1,000 mg film-coated tablets Empagliflozin/metformin hydrochloride
Slovak: Synjardy 5 mg/850 mg filmom obalené tablety Synjardy 5 mg/1000 mg filmom obalené tablety Synjardy 12,5 mg/850 mg filmom obalené tablety Synjardy 12,5 mg/1000 mg filmom obalené tablety empagliflozín/metformíniumchlorid
English: Therefore the effect was attenuated at week 94, with an adjusted mean (SE) improvement in HbA1c of 0.08% (0.02) in the placebo group, 0.50% (0.02) and 0.55% (0.02) in the empagliflozin 10 and 25 mg groups.
Slovak: % (0,02) v skupine s placebom, 0,50 % (0,02) v skupine s 10 mg empagliflozínu a 0,55
English: A greater proportion of patients with a baseline HbA1c ≥7.0% and treated with empagliflozin plus linagliptin achieved a target HbA1c of <7% compared to linagliptin 5 mg. Clinically meaningful reductions in HbA1c were maintained for 52 weeks.
Slovak: 7 % sa dosiahla pri väčšom podiele pacientov liečených empagliflozínom, s východiskovou hodnotou HbA1c ≥ 7,0 % a liečených empagliflozínom a linagliptínom v porovnaní s 5 mg linagliptínu.
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Subgroup analysis for patients on additional background of metformin (FAS, LOCF) Mean adjusted for baseline value Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure LOCF, values after antihypertensive rescue censored * p-value <0.0001 ** p-value <0.01
Slovak: Celý analyzovaný súbor (FAS) s použitím prevodu hodnôt z posledného sledovania (LOCF) pred podaním záchrannej liečby glykémie Analýza podskupiny u pacientov užívajúcich základnú liečbu metformínom (FAS, LOCF)
English: Synjardy 5 mg/850 mg film-coated tablets EU/1/15/1003/001
Slovak: Synjardy 5 mg/850 mg filmom obalené tablety EU/1/15/1003/001
English: EU/1/15/1003/019 10 film-coated tablets EU/1/15/1003/020 14 film-coated tablets EU/1/15/1003/021 30 film-coated tablets EU/1/15/1003/022 56 film-coated tablets EU/1/15/1003/023 60 film-coated tablets EU/1/15/1003/039 90 film-coated tablets EU/1/15/1003/024 100 film-coated tablets
Slovak: EU/1/15/1003/019 10 filmom obalených tabliet EU/1/15/1003/020 14 filmom obalených tabliet EU/1/15/1003/021 30 filmom obalených tabliet EU/1/15/1003/022 56 filmom obalených tabliet EU/1/15/1003/023 60 filmom obalených tabliet EU/1/15/1003/039 90 filmom obalených tabliet EU/1/15/1003/024 100 filmom obalených tabliet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/1,000 mg
Slovak: BYŤ UVEDENÉ NA VONKAJŠOM OBALE VIACPOČETNÉ BALENIE - DOČASNÁ ŠKATUĽKA BEZ BLUE BOXU - 12,5 mg/1 000 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/1,000 mg
Slovak: BYŤ UVEDENÉ NA VONKAJŠOM OBALE VIACPOČETNÉ BALENIE - DOČASNÁ ŠKATUĽKA BEZ BLUE BOXU - 5 mg/1 000 mg
English: Major hypoglycaemia (events requiring assistance) The overall frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin, and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components, and as adjunct to standard care therapy.
Slovak: %) a podobná pri empagliflozíne a placebe vo forme prídavnej liečby k metformínu a pri kombinácii empagliflozínu s metformínom u pacientov doteraz neliečených liekmi v porovnaní s pacientmi liečenými empagliflozínom a metformínom ako samostatnými zložkami a ako prídavná liečba k štandardnej liečbe.
English: Synjardy 12.5 mg/1,000 mg film-coated tablets EU/1/15/1003/028
Slovak: Synjardy 12,5 mg/1000 mg filmom obalené tablety EU/1/15/1003/028
English: Synjardy 5 mg/1,000 mg film-coated tablets EU/1/15/1003/010
Slovak: Synjardy 5 mg/1000 mg filmom obalené tablety EU/1/15/1003/010
English: In patients with mild, moderate or severe renal impairment (creatinine clearance <30 - <90 ml/min) and patients with kidney failure/end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively compared to subjects with normal renal function.
Slovak: 90 ml/min) o 66 % a u pacientov so zlyhávaním obličiek/ochorením obličiek v terminálnom štádiu (ESRD) približne o 48
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 6), and a clinically meaningful reduction in FPG, compared to glimepiride.
Slovak: u pacientov s nedostatočnou kontrolou glykémie užívajúcich metformín samostatne viedla liečba empagliflozínom podávaným denne k superiórnemu zníženiu hodnoty HbA1c (tabuľka 6) a ku klinicky významnému zníženiu FPG v porovnaní s glimepiridom.
English: Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovak: Synjardy 5 mg/850 mg obsahuje 5 mg empagliflozínu a 850 mg metformíniumchloridu.
English: Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019
Slovak: Synjardy 12,5 mg/850 mg filmom obalené tablety EU/1/15/1003/019
English: Empagliflozin as add-on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone and metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 3).
Slovak: Empagliflozín vo forme prídavnej liečby k metformínu, sulfonylmočovine, pioglitazónu Empagliflozín vo forme prídavnej liečby k metformínu, metformínu a sulfonylmočovine alebo pioglitazónu a metformínu viedol k štatisticky významným (p <
English: Do not drive or use any tools or machines if you feel dizzy while taking Synjardy.
Slovak: Ak počas užívania lieku Synjardy pociťujete závrat, neveďte vozidlo ani neobsluhujte žiadne nástroje alebo stroje.
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).
Slovak: Tmavohnedé fialové, oválne, bikonvexné filmom obalené tablety s vyrazeným „S12“ a logom Boehringer Ingelheim na jednej strane a „1000“ na druhej strane (dĺžka tablety: 21,1 mm, hrúbka tablety: 9,7 mm).
English: Dysuria
Slovak: Dysúria
English: Pinkish white, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm).
Slovak: Ružovobiele, oválne, bikonvexné filmom obalené tablety s vyrazeným „S12“ a logom Boehringer Ingelheim na jednej strane a „850“ na druhej strane (dĺžka tablety: 19,2 mm, hrúbka tablety: 9,4 mm).
English: Yellowish white, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm).
Slovak: Žltobiele, oválne, bikonvexné filmom obalené tablety s vyrazeným „S5“ a logom Boehringer Ingelheim na jednej strane a „850“ na druhej strane (dĺžka tablety: 19,2 mm, hrúbka tablety: 9,4 mm).
English: Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
Slovak: • inhibítormi transportéra OCT2 (napr. cimetidín, dolutegravir, ranolazín, trimetoprim, vandetanib,
English: The results of bioequivalence studies in healthy subjects demonstrated that Synjardy (empagliflozin/metformin hydrochloride) 5 mg/850 mg, 5 mg/1,000 mg, 12.5 mg/850 mg, and 12.5 mg/1,000 mg combination tablets are bioequivalent to co-administration of corresponding doses of empagliflozin and metformin as individual tablets.
Slovak: 5 mg/850 mg, 5 mg/1000 mg, 12,5 mg/850 mg a 12,5 mg/1000 mg sú bioekvivalentné so súbežným podávaním príslušných dávok empagliflozínu a metformínu vo forme oddelených tabliet.
English: Met = metformin; empa = empagliflozin mean adjusted for baseline value Analyses were performed on the full analysis set (FAS) using an observed cases (OC) approach Given in two equally divided doses per day when given together with metformin Given in two equally divided doses per day *p≤0.0062 for HbA1c
Slovak: Podávané v dvoch rovnako rozdelených dávkach denne pri podávaní spolu s metformínom Podávané v dvoch rovnako rozdelených dávkach denne *p ≤
English: In a prespecified subgroup of patients with baseline HbA1c greater or equal than 8.5% the reduction from baseline in HbA1c was -1.3% with empagliflozin 10 mg or 25 mg at 24 weeks (p<0.0001) compared to placebo.
Slovak: Vo vopred špecifikovanej podskupine pacientov s východiskovou hodnotou HbA1c vyššou alebo rovnou 8,5 % bol pokles východiskovej hodnoty HbA1c -1,3
English: Synjardy 12.5 mg/850 mg film-coated tablets are pinkish white, oval, biconvex.
Slovak: Synjardy 12,5 mg/850 mg filmom obalené tablety sú ružovobiele, oválne, po obidvoch stranách vypuklé.
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%
Slovak: 7 % sa dosiahla pri väčšom podiele pacientov liečených empagliflozínom a s východiskovou hodnotou HbA1c ≥ 7,0
English: Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovak: Synjardy 12,5 mg/850 mg obsahuje 12,5 mg empagliflozínu a 850 mg metformíniumchloridu.
English: Empagliflozin as add-on to multiple daily insulin
Slovak: Empagliflozín dvakrát denne oproti dávkovaniu jedenkrát denne vo forme prídavnej liečby k liečbe metformínom
English: Eli Lilly Italia S.p.A. Tel: +39 055 42571
Slovak: Tel: +39 055 42571
English: Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex.
Slovak: Synjardy 12,5 mg/1000 mg filmom obalené tablety sú tmavohnedé fialové, oválne, po obidvoch stranách vypuklé.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovak: Každá tableta obsahuje 12,5 mg empagliflozínu a 850 mg metformíniumchloridu.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL
Slovak: Synjardy 5 mg/850 mg tablety empagliflozín/metformínium
English: Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovak: Synjardy 5 mg/1000 mg obsahuje 5 mg empagliflozínu a 1000 mg metformíniumchloridu.
English: Blood creatinine increased/Glomerular filtration rate decreased The overall frequency of patients with increased blood creatinine and decreased glomerular filtration rate were similar between empagliflozin and placebo as add-on to metformin (blood creatinine increased: empagliflozin 10 mg 0.5%, empagliflozin 25 mg 0.1%, placebo 0.4%; glomerular filtration rate decreased: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, placebo 0.2%).
Slovak: Celková frekvencia výskytu pacientov so zvýšenou hladinou kreatinínu v krvi a poklesom glomerulárnej filtrácie bola podobná pri empagliflozíne a placebe vo forme prídavnej liečby k metformínu (nárast kreatinínu v krvi: empagliflozín 10 mg 0,5
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Slovak: Synjardy 5 mg/850 mg filmom obalené tablety empagliflozín/metformíniumchlorid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovak: Každá tableta obsahuje 12,5 mg empagliflozínu a 1000 mg metformíniumchloridu.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovak: Každá tableta obsahuje 5 mg empagliflozínu a 850 mg metformíniumchloridu.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg tablets empagliflozin/metformin HCL
Slovak: Synjardy 12,5 mg/850 mg tablety empagliflozín/metformínium
English: No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea and as add-on to linagliptin and metformin.
Slovak: Pri kombinácii metformínu a sulfonylmočoviny a vo forme prídavnej liečby k linagliptínu a metformínu sa udalosť silnej hypoglykémie nevyskytla u žiadneho pacienta.
English: Brownish yellow, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm).
Slovak: Hnedožlté, oválne, bikonvexné filmom obalené tablety s vyrazeným „S5“ a logom Boehringer Ingelheim na jednej strane a „1000“ na druhej strane (dĺžka tablety: 21,1 mm, hrúbka tablety: 9,7 mm).
English: INFORMATION IN BRAILLE Synjardy 5 mg/1,000 mg
Slovak: BLUE BOXU - 5 mg/1000 mg
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg tablets empagliflozin/metformin HCL
Slovak: Synjardy 5 mg/1000 mg tablety empagliflozín/metformínium
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Slovak: Synjardy 12,5 mg/850 mg filmom obalené tablety empagliflozín/metformíniumchlorid
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Slovak: Synjardy 5 mg/1000 mg filmom obalené tablety empagliflozín/metformíniumchlorid
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Slovak: Synjardy 12,5 mg/1000 mg filmom obalené tablety empagliflozín/metformíniumchlorid
English: Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovak: Synjardy 12,5 mg/1000 mg obsahuje 12,5 mg empagliflozínu a 1000 mg metformíniumchloridu.
English: Synjardy 5 mg/1,000 mg film-coated tablets are brownish yellow, oval, biconvex.
Slovak: Synjardy 5 mg/850 mg filmom obalené tablety sú žltobiele, oválne, po obidvoch stranách vypuklé.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg tablets empagliflozin/metformin HCL
Slovak: Synjardy 12,5 mg/1000 mg tablety empagliflozín/metformínium
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority CV Death N (%) Hazard ratio vs. placebo (95% CI) p-value Non-fatal MI N (%) Hazard ratio vs. placebo (95% CI) p−value Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI) CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Slovak: KV = kardiovaskulárne, IM = infarkt myokardu Liečený súbor (LS), t.j. pacienti, ktorí dostali minimálne jednu dávku skúšaného lieku Združené dávky empagliflozínu 10 mg a 25 mg Keďže údaje zo skúšania boli súčasťou predbežnej analýzy, uvádza sa 95,02 % interval spoľahlivosti s dvomi desatinnými miestami
English: HbA1c (%) Baseline (mean) Change from baseline Comparison vs. empa (95% CI)
Slovak: 0,0001) zníženia hodnoty HbA1c (zmena od východiskovej hodnoty -1,08
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/034 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/035 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/036 200 (2 x 100 x 1) film-coated tablets
Slovak: REGISTRAČNÉ ČÍSLA EU/1/15/1003/034 120 (2 x 60 x 1) filmom obalených tabliet EU/1/15/1003/035 180 (2 x 90 x 1) filmom obalených tabliet EU/1/15/1003/036 200 (2 x 100 x 1) filmom obalených tabliet
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovak: Každá tableta obsahuje 5 mg empagliflozínu a 1000 mg metformíniumchloridu.
English: Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo, respectively, were total cholesterol 5.0% and 5.2% versus 3.7%; HDL-cholesterol 4.6% and 2.7% versus -0.5%; LDL-cholesterol 9.1% and 8.7% versus 7.8%; triglycerides 5.4% and 10.8% versus 12.1%.
Slovak: Priemerné percentuálne nárasty v porovnaní s východiskovou hodnotou boli pri celkovom cholesterole 5,0 % pre 10 mg empagliflozínu a 5,2 % pre 25 mg empagliflozínu v porovnaní s 3,7 % pre placebo; pri HDL-cholesterole
English: Baseline (mean) Change from baseline Difference from glimepiride
Slovak: Rozdiel oproti glimepiridu
English: What Synjardy contains
Slovak: Ako vyzerá Synjardy a obsah balenia
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/025 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/026 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/027 200 (2 x 100 x 1) film-coated tablets
Slovak: REGISTRAČNÉ ČÍSLA EU/1/15/1003/025 120 (2 x 60 x 1) filmom obalených tabliet EU/1/15/1003/026 180 (2 x 90 x 1) filmom obalených tabliet EU/1/15/1003/027 200 (2 x 100 x 1) filmom obalených tabliet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/016 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/017 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/018 200 (2 x 100 x 1) film-coated tablets
Slovak: REGISTRAČNÉ ČÍSLA EU/1/15/1003/016 120 (2 x 60 x 1) filmom obalených tabliet EU/1/15/1003/017 180 (2 x 90 x 1) filmom obalených tabliet EU/1/15/1003/018 200 (2 x 100 x 1) filmom obalených tabliet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/007 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/008180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/009 200 (2 x 100 x 1) film-coated tablets
Slovak: REGISTRAČNÉ ČÍSLA EU/1/15/1003/007 120 (2 x 60 x 1) filmom obalených tabliet EU/1/15/1003/008 180 (2 x 90 x 1) filmom obalených tabliet EU/1/15/1003/009 200 (2 x 100 x 1) filmom obalených tabliet
English: Adults with normal renal function (GFR ≥90 ml/min) The recommended dose is one tablet twice daily.
Slovak: Dospelí s normálnou funkciou obličiek (GFR ≥
English: Your doctor may ask you to stop taking Synjardy until you have recovered.
Slovak: aby ste Synjardy prestali užívať dovtedy, kým sa stav neupraví.
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Slovak: Pomer rizika v porovnaní s placebom (95 % CI) p-hodnota Nefatálny IM N (%)
English: Colloidal anhydrous silica
Slovak: U pacientov s diabetes mellitus
English: p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups
Slovak: 0,0023 a oproti skupinám s kombinovanou liečbou sulfonylmočovinou a inzulínom v monoterapii (40,1 udalostí/1000 pacientorokov), p =
English: EU/1/15/1003/001 10 film-coated tablets EU/1/15/1003/002 14 film-coated tablets EU/1/15/1003/003 30 film-coated tablets EU/1/15/1003/004 56 film-coated tablets EU/1/15/1003/005 60 film-coated tablets EU/1/15/1003/037 90 film-coated tablets EU/1/15/1003/006 100 film-coated tablets
Slovak: 56 filmom obalených tabliet EU/1/15/1003/005 60 filmom obalených tabliet EU/1/15/1003/037 90 filmom obalených tabliet EU/1/15/1003/006 100 filmom obalených tabliet
English: • diarrhoea or stomach ache
Slovak: • hnačka alebo bolesť žalúdka, • strata chuti do jedla.
English: Synjardy 5 mg/850 mg film-coated tablets and Synjardy 5 mg/1,000 mg film-coated tablets Tablet core
Slovak: Synjardy 5 mg/850 mg filmom obalené tablety a Synjardy 5 mg/1000 mg filmom obalené tablety Jadro tablety kukuričný škrob kopovidón (K-hodnota nominálne 28) bezvodý koloidný oxid kremičitý magnéziumstearát
English: EU/1/15/1003/028 10 film-coated tablets EU/1/15/1003/029 14 film-coated tablets EU/1/15/1003/030 30 film-coated tablets EU/1/15/1003/031 56 film-coated tablets EU/1/15/1003/032 60 film-coated tablets EU/1/15/1003/040 90 film-coated tablets EU/1/15/1003/033 100 film-coated tablets
Slovak: 56 filmom obalených tabliet EU/1/15/1003/032 60 filmom obalených tabliet EU/1/15/1003/040 90 filmom obalených tabliet EU/1/15/1003/033 100 filmom obalených tabliet
English: EU/1/15/1003/010 10 film-coated tablets EU/1/15/1003/011 14 film-coated tablets EU/1/15/1003/012 30 film-coated tablets EU/1/15/1003/013 56 film-coated tablets EU/1/15/1003/014 60 film-coated tablets EU/1/15/1003/038 90 film-coated tablets EU/1/15/1003/015 100 film-coated tablets
Slovak: 56 filmom obalených tabliet EU/1/15/1003/014 60 filmom obalených tabliet EU/1/15/1003/038 90 filmom obalených tabliet EU/1/15/1003/015 100 filmom obalených tabliet
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Slovak: HbA1c a telesnej hmotnosti v porovnaní s placebom (tabuľka 5).
English: Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core
Slovak: Synjardy 12,5 mg/850 mg filmom obalené tablety a Synjardy 12,5 mg/1000 mg filmom obalené tablety Jadro tablety kukuričný škrob kopovidón (K-hodnota nominálne 28) bezvodý koloidný oxid kremičitý magnéziumstearát
English: 90 (3 x 30) tablets (multipack)
Slovak: 90 (3 x 30) tabliet (viacpočetné balenie)
English: The application was withdrawn in the Netherlands and United Kingdom.
Slovak: V Holandsku a Spojenom kráľovstve bola žiadosť stiahnutá.
English: Portugal and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Slovak: Portugalsko a Nemecko upozornili na dôvody nesúhlasu agentúru EMEA 15. decembra 2004.
English: 21 February 2006 EMEA/CHMP/373061/2005
Slovak: 21 február 2006 EMEA/CHMP/373061/2005
English: The Reference Member State was Finland and the Concerned Member States were Austria, Belgium, Denmark, Germany, Italy, Luxembourg, the Netherlands, Portugal, Sweden and United Kingdom.
Slovak: Fínsko bolo referenčným členským štátom a Rakúsko, Belgicko, Dánsko, Nemecko, Taliansko, Luxembursko, Holandsko, Portugalsko, Švédsko a Spojené kráľovstvo boli dotknutými členskými štátmi.
English: The final opinion was converted into a Decision by the European Commission on 21 February 2006.
Slovak: Konečné stanovisko bolo prepracované na rozhodnutie Európskej komisie zo dňa 21 februára 2006.
English: The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovak: Tieto členské štáty nedospeli k dohode v rámci postupu vzájomného uznávania rozhodnutia o uvedení na trh, ktoré bolo udelené referenčnému členskému štátu.
English: The Marketing Authorisation Holder provided written explanations on 20 July 2005.
Slovak: Držiteľ rozhodnutia o uvedení lieku na trh predložil písomné vysvetlenie 20. júla 2005.
English: During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazol-ratiopharm.
Slovak: Na zasadnutí v septembri 2005 výbor CHMP vzhľadom na všetky predložené údaje a vedeckú diskusiu v rámci výboru dospel k stanovisku, že pomer prínosu a rizika pre liek Lansoprazol