FrancophonIA/ELRC3.0 huggingface dataset:
English: HbA1c (%) at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) 24 hour SBP at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) 24 hour DBP at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) Full analysis set (FAS) LOCF, values after taking antidiabetic rescue therapy censored Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001 ** p-value <0.001
Icelandic: Notast var við upplýsingar sem komu fram í síðasta mati sem fór fram, gildi eftir blóðsykurslækkandi neyðarmeðferð voru skert Meðaltal aðlagað að grunngildi HbA1c, grunngildi eGFR, landfræðilegri staðsetningu og fjölda blóðþrýstingslækkandi lyfja Notast var við upplýsingar sem komu fram í síðasta mati sem fór fram, gildi eftir blóðsykurslækkandi neyðarmeðferð eða eftir að blóðþrýstingslækkandi neyðarmeðferð var breytt voru skert Meðaltal aðlagað að grunngildi slagbilsþrýstings, grunngildi HbA1c, grunngildi eGFR, landfræðilegri staðsetningu og fjölda blóðþrýstingslækkandi lyfja Meðaltal aðlagað að grunngildi þanbilsþrýstings, grunngildi HbA1c, grunngildi eGFR, landfræðilegri staðsetningu og fjölda blóðþrýstingslækkandi lyfja * p-gildi < 0,0001 ** p-gildi < 0,001
English: Synjardy 5 mg/1,000 mg film-coated tablets EU/1/15/1003/010
Icelandic: Synjardy 5 mg/1.000 mg filmuhúðaðar töflur EU/1/15/1003/010
English: Glycaemic efficacy and cardiovascular outcomes have been assessed in a total of 10,366 patients with type 2 diabetes who were treated in 9 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 2950 patients received empagliflozin 10 mg and 3701 received empagliflozin 25 mg as add-on to metformin therapy.
Icelandic: Mat hefur verið lagt á blóðsykurstjórnandi verkun og áhrif á hjarta- og æðakerfið hjá alls 10.366 sjúklingum með sykursýki af tegund 2 meðferð í 9 tvíblindum klínískum samanburðarrannsóknum með lyfleysu eða virkum samanburði í minnst 24 vikur.
English: A greater proportion of patients treated with empagliflozin and with a baseline HbA1c ≥7.0% achieved a target HbA1c of <7% compared to placebo (Table 8).
Icelandic: ≥ 7,0 % náðu markgildi HbA1c < 7 % miðað við lyfleysu (tafla 8).
English: Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Icelandic: Hver Synjardy 12,5 mg/850 mg filmuhúðuð tafla (tafla) inniheldur 12,5 mg empagliflozin og 850 mg metformínhýdróklóríð.
English: Treatment with empagliflozin as add-on to metformin or metformin plus sulfonylurea resulted in clinically meaningful improvement of 2-hour post-prandial glucose (meal tolerance test) at 24 weeks (add-on to metformin, placebo: +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg/dl; add-on to metformin plus sulphonylurea, placebo: -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
Icelandic: -44,6 mg/dl, viðbót við metformín auk súlfónýlúrealyfs, lyfleysa -2,3 mg/dl, empagliflozin 10 mg: -35,7 mg/dl, empagliflozin 25 mg: -36,6 mg/dl).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 5 mg empagliflozin og 850 mg metformínhýdróklóríð.
English: Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019
Icelandic: Synjardy 12,5 mg/850 mg filmuhúðaðar töflur EU/1/15/1003/019
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 12,5 mg empagliflozin og 850 mg metformínhýdróklóríð.
English: The efficacy and safety of empagliflozin as add-on to multiple daily insulin with concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 52 weeks duration.
Icelandic: Empagliflozin sem viðbót við meðferð með insúlíni oft á dag Verkun og öryggi empagliflozins sem viðbót við gjöf insúlíns oft á dag, með samhliða meðferð með metformíni, var metið í tvíblindri samanburðarrannsókn með lyfleysu sem stóð yfir í 52 vikur.
English: Table 3: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapy
Icelandic: Niðurstöður varðandi verkun úr 24 vikna samanburðarrannsóknum með lyfleysu Viðbót við meðferð með metformíni
English: Synjardy 12.5 mg/850 mg film-coated tablets are pinkish white, oval, biconvex.
Icelandic: Synjardy 12,5 mg/850 mg filmuhúðaðar töflur eru fölbleikar, sporöskjulaga og tvíkúptar.
English: Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) If you take Synjardy with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is increased.
Icelandic: Ef þú tekur Synjardy með öðru lyfi sem getur leitt til lágs blóðsykurs, svo sem súlfónýlúrealyfi eða með insúlíni, eykst hættan á of lágum blóðsykri.
English: Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets.
Icelandic: 180 (2 pakkningar með 90 x 1) filmuhúðaðar töflur.
English: Synjardy 5 mg/1,000 mg film-coated tablets are brownish yellow, oval, biconvex.
Icelandic: Synjardy 5 mg/1.000 mg filmuhúðaðar töflur eru brúngular, sporöskjulaga og tvíkúptar.
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Icelandic: HbA1c (%) í viku 18 Grunnlína (meðaltal) Breyting frá grunnlínu
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 12,5 mg empagliflozin og 1000 mg metformínhýdróklóríð.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 5 mg empagliflozin og 1000 mg metformínhýdróklóríð.
English: Empagliflozin induced renal tumours in male mice at 1,000 mg/kg/day, but not at 300 mg/kg/day, which corresponds to approximately 11-times the maximal clinical exposure to empagliflozin.
Icelandic: Empagliflozin hafði í för með sér æxli í nýrum hjá karlkyns rottum við 1.000 mg/kg/sólarhring, en ekki við 300 mg/kg/sólarhring, sem samsvarar u.þ.b.
English: See subsections below for additional information
Icelandic: Sjá ítarlegri upplýsingar í köflunum hér á eftir
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.
Icelandic: < 100 mg/dl [5,5 mmól/l] fyrir máltíðir og < 140 mg/dl [7,8 mmól/l] eftir máltíðir á vikum 19 til 40.
English: Consistent with the half-life, up to 22% accumulation, with respect to plasma AUC, was observed at steady-state.
Icelandic: Uppsöfnun var allt að 22 % við jafnvægi, að því er varðar flatarmál undir blóðþéttniferli (AUC) í plasma, sem er í samræmi við helmingunartímann.
English: Colloidal anhydrous silica
Icelandic: Meltingarfæri Einkenni frá meltingarfærum
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 May 2015
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS
English: • abnormalities in liver function tests, inflammation of the liver (hepatitis)
Icelandic: óeðlilegar niðurstöður lifrarprófa, lifrarbólga
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Icelandic: D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ NOTKUN LYFSINS
English: Nervous system disorders
Icelandic: Hætta á blóðrúmmálsskerðingu
English: Urine laboratory assessments Due to its mechanism of action, patients taking Synjardy will test positive for glucose in their urine.
Icelandic: Vegna verkunarháttar lyfsins mun glúkósi mælast í þvagi sjúklinga sem nota Synjardy.
English: Synjardy 5 mg/850 mg film-coated tablets and Synjardy 5 mg/1,000 mg film-coated tablets Tablet core
Icelandic: Synjardy 5 mg/850 mg filmuhúðaðar töflur og Synjardy 5 mg/1000 mg filmuhúðaðar töflur Töflukjarni
English: Systemic exposure of empagliflozin increased in a dose-proportional manner.
Icelandic: Altæk útsetning fyrir empagliflozini jókst í réttu hlutfalli við skammta.
English: Foot care
Icelandic: Umhirða fóta
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Icelandic: Munur miðað við lyfleysu (95% CI) Fjöldi Slagbilsþrýstingur (mmHg) Grunnlína (meðaltal) Breyting frá grunnlínu
English: Urine glucose
Icelandic: Vatnsfrí kísilkvoða
English: Co-administration of metformin with Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin.
Icelandic: OCT1 hemlum (svo sem verapamíli) getur dregið úr verkun metformíns.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg tablets empagliflozin/metformin HCL
Icelandic: Synjardy 12,5 mg/850 mg töflur empagliflozin/metformínhýdróklóríð
English: • thirst
Icelandic: • kláði
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg tablets empagliflozin/metformin HCL
Icelandic: Synjardy 5 mg/1000 mg töflur empagliflozin/metformínhýdróklóríð
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL
Icelandic: Synjardy 5 mg/850 mg töflur empagliflozin/metformínhýdróklóríð
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Icelandic: Synjardy 5 mg/1000 mg filmuhúðaðar töflur empagliflozin/metformínhýdróklóríð
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg tablets empagliflozin/metformin HCL
Icelandic: Synjardy 12,5 mg/1000 mg töflur empagliflozin/metformínhýdróklóríð
English: Urinary tract infection events were reported more frequently for empagliflozin 10 mg compared with placebo in female patients, but not for empagliflozin 25 mg.
Icelandic: 10 mg af empagliflozini en þeim sem fengu lyfleysu, en ekki hjá þeim sem fengu 25 mg af empagliflozini.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Icelandic: Synjardy 5 mg/850 mg filmuhúðaðar töflur empagliflozin/metformínhýdróklóríð
English: Hepatic impairment
Icelandic: Þvaglátstreg ða
English: What you need to know before you take Synjardy
Icelandic: Áður en byrjað er að nota Synjardy
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.
Icelandic: OCT2 hemlum (svo sem címetidíni, dólútegravíri, ranólazíni, trímetóprími, vandetanibi,
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
Icelandic: EU/1/15/1003/001 10 filmuhúðaðar töflur EU/1/15/1003/002 14 filmuhúðaðar töflur EU/1/15/1003/003 30 filmuhúðaðar töflur EU/1/15/1003/004 56 filmuhúðaðar töflur EU/1/15/1003/005 60 filmuhúðaðar töflur EU/1/15/1003/037 90 filmuhúðaðar töflur EU/1/15/1003/006 100 filmuhúðaðar töflur
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Icelandic: Synjardy 12,5 mg/850 mg filmuhúðaðar töflur empagliflozin/metformínhýdróklóríð
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Icelandic: Synjardy 12,5 mg/1000 mg filmuhúðaðar töflur empagliflozin/metformínhýdróklóríð
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
Icelandic: EU/1/15/1003/019 10 filmuhúðaðar töflur EU/1/15/1003/020 14 filmuhúðaðar töflur EU/1/15/1003/021 30 filmuhúðaðar töflur EU/1/15/1003/022 56 filmuhúðaðar töflur EU/1/15/1003/023 60 filmuhúðaðar töflur EU/1/15/1003/039 90 filmuhúðaðar töflur EU/1/15/1003/024 100 filmuhúðaðar töflur
English: Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core
Icelandic: Synjardy 12,5 mg/850 mg filmuhúðaðar töflur og Synjardy 12,5 mg/1000 mg filmuhúðaðar töflur Töflukjarni
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
Icelandic: EU/1/15/1003/028 10 filmuhúðaðar töflur EU/1/15/1003/029 14 filmuhúðaðar töflur EU/1/15/1003/030 30 filmuhúðaðar töflur EU/1/15/1003/031 56 filmuhúðaðar töflur EU/1/15/1003/032 60 filmuhúðaðar töflur EU/1/15/1003/040 90 filmuhúðaðar töflur EU/1/15/1003/033 100 filmuhúðaðar töflur
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).
Icelandic: Sporöskjulaga, dökkar, purpurabrúnar, tvíkúptar filmuhúðaðar töflur með „S12“ og kennimerki Boehringer Ingelheim ígreyptu á annarri hliðinni og „1000“ á hinni (lengd töflu:
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
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/15/1003/034 120 (2 x 60 x 1) filmuhúðaðar töflur EU/1/15/1003/035 180 (2 x 90 x 1) filmuhúðaðar töflur EU/1/15/1003/036 200 (2 x 100 x 1) filmuhúðaðar töflur
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
Icelandic: EU/1/15/1003/010 10 filmuhúðaðar töflur EU/1/15/1003/011 14 filmuhúðaðar töflur EU/1/15/1003/012 30 filmuhúðaðar töflur EU/1/15/1003/013 56 filmuhúðaðar töflur EU/1/15/1003/014 60 filmuhúðaðar töflur EU/1/15/1003/038 90 filmuhúðaðar töflur EU/1/15/1003/015 100 filmuhúðaðar töflur
English: Subgroup analysis of full analysis set (FAS) for patients on additional background of metforminCompleters using last observation carried forward (LOCF) prior to glycaemic rescue therapy mean adjusted for baseline value * p-value <0.0001 ** p-value ≤0.025
Icelandic: Greining á undirhópi sjúklinga úr heildarþýði sem einnig fengu metformín sem grunnmeðferðnotast var við upplýsingar varðandi einstaklinga sem luku meðferð, sem komu fram í síðasta mati sem fór fram áður en neyðarlyf var gefið til að ná stjórn á blóðsykri Meðaltal aðlagað að grunngildi * p-gildi < 0,0001 ** p-gildi ≤ 0,025
English: Overall exposure (AUCss) of empagliflozin over a 24-hour period with empagliflozin 5 mg administered twice daily was similar to empagliflozin 10 mg administered once daily.
Icelandic: (AUCss) empagliflozins á sólarhringstímabili með 5 mg af empagliflozini tvisvar á sólarhring var svipuð og með 10 mg af empagliflozini einu sinni á sólarhring.
English: Gastrointestinal symptoms
Icelandic: Samkvæmt samantektargreiningu á tvíblindum
English: Metformin Concomitant use not recommended
Icelandic: Ekki má nota metformín
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Icelandic: Munur miðað við lyfleysu (97,5 % CI) Fjöldi Slagbilsþrýstingur (mmHg) Grunnlína (meðaltal) Breyting frá grunnlínu
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
Icelandic: Munur miðað við lyfleysu (95 % CI) Greining á heildarþýði þar sem notast var við upplýsingar sem komu fram í síðasta mati sem fór fram áður en blóðsykurslækkandi neyðarmeðferð hóst Greining á undirhópi sjúklinga sem einnig fengu metformín sem grunnmeðferð (greining á heildarþýði, upplýsingar úr síðasta mati sem fór fram) Meðaltal aðlagað að grunngildi
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Synjardy.
Icelandic: Eftirfarandi upplýsingar lýsa lyfjahvörfum virkra innihaldsefna Synjardy.
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
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/15/1003/025 120 (2 x 60 x 1) filmuhúðaðar töflur EU/1/15/1003/026 180 (2 x 90 x 1) filmuhúðaðar töflur EU/1/15/1003/027 200 (2 x 100 x 1) filmuhúðaðar töflur
English: Basal insulin dose (IU/day) at week 78
Icelandic: Skammtur grunninsúlíns (a.e./sólarhring) í viku 78 Grunnlína (meðaltal) Breyting frá grunnlínu
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
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/15/1003/007 120 (2 x 60 x 1) filmuhúðaðar töflur EU/1/15/1003/008 180 (2 x 90 x 1) filmuhúðaðar töflur EU/1/15/1003/009 200 (2 x 100 x 1) filmuhúðaðar töflur
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
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/15/1003/016 120 (2 x 60 x 1) filmuhúðaðar töflur EU/1/15/1003/017 180 (2 x 90 x 1) filmuhúðaðar töflur EU/1/15/1003/018 200 (2 x 100 x 1) filmuhúðaðar töflur
English: Therefore, special attention should be given to their volume intake in case of coadministered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).
Icelandic: Gæta skal varúðar hjá sjúklingum sem fá metformín þegar hefja á meðferð með lyfjum sem geta valdið bráðri skerðingu á nýrnastarfsemi (t.d. blóðþrýstingslækkandi lyf, þvagræsilyf og bólgueyðandi verkjalyf).
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Icelandic: Fjöldi HbA1c (%) Grunnlína (meðaltal) Breyting frá grunnlínu
English: Subgroup analysis for patients on additional background of metformin (FAS, LOCF)
Icelandic: marktæka minnkun á raunáhættu á heildardánartíðni: metformín:
English: Baseline (mean) Change from baseline Difference from glimepiride
Icelandic: Grunnlína (meðaltal) Breyting frá grunnlínu
English: The intensity of urinary tract infections (i.e. mild/moderate/severe) was similar to placebo.
Icelandic: Alvarleiki þvagfærasýkinga (væg, miðlungsalvarleg eða alvarleg) var svipaður og hjá þeim sem fengu lyfleysu.
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).
Icelandic: Sporöskjulaga, brúngular, tvíkúptar filmuhúðaðar töflur með „S5“ og kennimerki Boehringer Ingelheim ígreypt á annarri hliðinni og „1000“ á hinni (lengd töflu:
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Icelandic: B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN Lyfseðilsskylt lyf.
English: Do not take Synjardy if you are pregnant.
Icelandic: Ekki má nota Synjardy á meðgöngu.
English: The single-dose and steady-state pharmacokinetic parameters of empagliflozin were similar suggesting linear pharmacokinetics with respect to time.
Icelandic: Lyfjahvarfabreytur stakra skammta empagliflozins og við jafnvægi voru svipaðar og bentu til línulegra lyfjahvarfa að því er varðar tíma.
English: • reduced body temperature and heartbeat
Icelandic: Niðurstaða með tilliti til hjarta- og æðakerfisins
English: • other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Icelandic: önnur blóðsykurslækkandi lyf, svo sem insúlín eða súlfónýlúrealyf.
English: Empagliflozin did not increase the incidence of tumours in female mice at doses up to 1,000 mg/kg/day, which corresponds to approximately 62-times the maximal clinical exposure to empagliflozin.
Icelandic: Empagliflozin jók ekki tíðni æxlamyndunar hjá kvenkyns músum með skömmtum upp að 1.000 mg/kg/sólarhring, sem samsvarar u.þ.b.
English: The removal of empagliflozin by haemodialysis has not been studied.
Icelandic: Ekki hefur verið rannsakað hvort empagliflozin skiljist út með blóðskilun.
English: 1st injection: from 1.5 months of age.
Icelandic: Fyrri inndæling: frá 1,5 mánaðar aldri.
English: 2nd injection: after 3 weeks.
Icelandic: Seinni inndæling: eftir 3 vikur.
English: Date of last renewal: 07/01/2016
Icelandic: Nýjasta dagsetning endurnýjunar markaðsleyfis: 07/01/2016
English: ATCvet code: QI04AA02.
Icelandic: QI04AA02
English: The level of efficacy for other species may differ from that observed in sheep.
Icelandic: Verkun hjá öðrum tegundum getur verið önnur en sést hefur hjá sauðfé.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Icelandic: *(Cycling value (Ct) ≥ 36 samkvæmt gildaðri RT-PCR-aðferð (Real-Time Polymerase Chain Reaction Method), sem bendir til þess að ekkert veiruerfðaefni sé fyrir hendi).
English: Off-white or pink liquid.
Icelandic: Beinhvítur eða bleikur vökvi.
English: a) the administration of the product to animals will interfere with the implementation of national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Icelandic: a) sé lyfið gefið dýrum muni það trufla framkvæmd innlendrar áætlunar er varðar greiningu, útrýmingu eða baráttu gegn dýrasjúkdómum eða geri erfitt um vik að staðfesta að smit sé ekki til staðar í lifandi dýrum eða matvælum eða öðrum afurðum úr dýrum sem hafa fengið lyfið.
English: The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Icelandic: Hjálparefnin (þ.m.t. ónæmisglæðar) sem talin eru upp í kafla 6.1 í samantekt á eiginleikum lyfsins eru ýmist leyfð innihaldsefni sem ekki þurfa gildi fyrir hámark lyfjaleifa samkvæmt töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010 eða talin falla utan reglugerðar Evrópuráðsins nr. 470/2009 þegar þau eru notuð eins og í þessu dýralyfi.
English: High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Icelandic: Hettuglös úr þéttu pólýetýleni (High Density Polyethylene (HDPE)) með tappa úr teygjanlegu klórbútýl-efni og innsigli úr áli, sem taka 20, 100 eða 240 ml og innihalda 10, 50 eða 120 skammta af bóluefninu.
English: Each dose of 2 ml of vaccine contains:
Icelandic: Hver 2 ml skammtur af bóluefni inniheldur: