FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters Not all pack sizes may be marketed.
Slovenian: Velikosti pakiranj s 30 x 1 in 90 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10% for dapagliflozin and 0.20% for glipizide.
Slovenian: 208. teden je bila prilagojena povprečna sprememba HbA1c od izhodišča pri dapagliflozinu -0,10 % in pri glipizidu 0,20 %.
English: dUrinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
Slovenian: Okužbe sečil obsegajo naslednje prednostne izraze, naštete v zaporedju opisanih pogostnosti: okužba sečil, cistitis, okužba sečil z Escherichio, okužba genitourinarnega trakta, pielonefritis, trigonitis, uretritis, okužba ledvic in prostatitis.
English: The proportion of subjects remaining in the study at Week 104 was 72.4% for the group treated with dapagliflozin 10 mg and 54.8% for the placebo group.
Slovenian: Delež preiskovancev, ki so 104. teden še ostali v študiji, je bil v skupini z 10 mg dapagliflozina 72,4 % in v skupini s placebom
English: Dapagliflozin exposure increased proportional to the increment in dapagliflozin dose over the range of 0.1 to 500 mg and its pharmacokinetics did not change with time upon repeated daily dosing for up to 24 weeks.
Slovenian: Izpostavljenost dapagliflozinu se je v razponu odmerkov od 0,1 do 500 mg povečevala sorazmerno s povečevanjem odmerka.
English: • urinary tract infection, seen commonly.
Slovenian: • okužba sečil, ki se lahko pojavi pogosto.
English: The mean plasma terminal half-life (t1/2) for dapagliflozin was 12.9 hours following a single oral dose of dapagliflozin 10 mg to healthy subjects.
Slovenian: Po enkratnem peroralnem odmerku 10 mg dapagliflozina pri zdravih osebah je bil povprečni plazemski končni razpolovni čas (t1/2) dapagliflozina 12,9 ure.
English: What Forxiga contains
Slovenian: Kaj vsebuje zdravilo Forxiga
English: Kidney function Your kidneys should be checked before you start taking and whilst you are on this medicine.
Slovenian: Pred začetkom jemanja in med zdravljenjem s tem zdravilom je treba preverjati vaše ledvice.
English: INFORMATION IN BRAILLE Forxiga 10 mg
Slovenian: forxiga 10 mg
English: 6.6 Special precautions for disposal No special requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje
English: Approximately 70 g of glucose was excreted in the urine per day (corresponding to 280 kcal/day) at a dapagliflozin dose of 10 mg/day in subjects with type 2 diabetes mellitus for 12 weeks.
Slovenian: Med 12-tedensko uporabo dapagliflozina v odmerku 10 mg na dan, se je pri osebah s sladkorno boleznijo tipa 2 izločilo z urinom približno 70 g glukoze na dan (to ustreza 280 kcal/dan).
English: • Forxiga 10 mg film-coated tablets are yellow and diamond-shaped approximately 1.1 x 0.8 cm diagonally.
Slovenian: • Tablete zdravila Forxiga 10 mg filmsko obložene tablete so rumene barve in rombaste oblike s približnimi diagonalami 1,1 x 0,8 cm. Na eni strani imajo vtisnjeno oznako "10" in na drugi strani "1428".
English: Constipation** Dry mouth**
Slovenian: Bolezni prebavil zaprtost suha usta
English: It is not known if DKA is more likely to occur with higher doses of dapagliflozin.
Slovenian: Ali je verjetnost za DKA med uporabo večjih odmerkov dapagliflozina večja, ni znano.
English: In the extension period, HbA1c reductions were sustained through Week 102 (-0.61%, and -0.17% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
Slovenian: V obdobju podaljšanja se je zmanjšanje HbA1c ohranilo do 102. tedna (prilagojena povprečna sprememba od izhodišča -0,61 % z 10 mg dapagliflozina in -0,17 % s placebom).
English: See package leaflet for further information.
Slovenian: Za dodatne informacije glejte navodilo za uporabo.
English: Body weight (kg) Baseline (mean) Change from baseline c
Slovenian: Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča c
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 November, 2012
Slovenian: 12. november 2012
English: Dapagliflozin 10 mg + insulin ± oral glucose-lowering medicinal products2
Slovenian: Parameter dapagliflozin 10 mg + insulin ± peroralni antidiabetiki placebo + insulin ± peroralni antidiabetiki b
English: A double-blind, placebo-controlled study of 24-week duration (with an additional extension period) was conducted to evaluate the safety and efficacy of monotherapy with Forxiga in subjects with inadequately controlled type 2 diabetes mellitus.
Slovenian: Za oceno varnosti in učinkovitosti monoterapije z zdravilom Forxiga pri osebah z neustrezno urejeno sladkorno boleznijo tipa 2 so izvedli 24-tedensko, dvojno slepo, s placebom kontrolirano študijo (z dodatnim obdobjem podaljšanja).
English: This grouping of reactions was reported in 3.2% and 1.8% of patients who received dapagliflozin 10 mg and placebo, respectively.
Slovenian: Ta skupina učinkov je bila opisana pri 3,2 % bolnikov, ki so prejemali 10 mg dapagliflozina, in pri 1,8 % tistih, ki so prejemali placebo.
English: Results at Week 24 (LOCFa) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products)
Slovenian: Rezultati s placebom kontrolirane študije dapagliflozina v kombinaciji z insulinom (samim ali skupaj s peroralnim antidiabetikom) po 24 tednih (LOCF
English: Dapagliflozin did not show any toxicity in healthy subjects at single oral doses up to 500 mg (50 times the maximum recommended human dose).
Slovenian: Enkratni peroralni odmerki dapagliflozina do 500 mg (tj. 50-kratnik največjega priporočenega odmerka za človeka) pri zdravih preiskovancih niso povzročili toksičnih učinkov.
English: Alu/Alu blister Pack sizes of 14, 28 and 98 film-coated tablets in non-perforated calendar blisters
Slovenian: Velikosti pakiranj s 14, 28 in 98 filmsko obloženimi tabletami v neperforiranih koledarskih pretisnih omotih.
English: At 48 weeks, the difference for dapagliflozin as add-on to sitagliptin (with or without metformin) compared with placebo was -2.22 kg. At 102 weeks, the difference for dapagliflozin as add-on to metformin compared with placebo, or as add-on to insulin compared with placebo was -2.14 and -2.88 kg, respectively.
Slovenian: Po 102 tednih je bila razlika z dapagliflozinom kot dodatkom metforminu v primerjavi s placebom -2,14 kg in kot dodatkom insulinu v primerjavi s placebom -2,88 kg.
English: ≥ 0.2% of subjects and ≥ 0.1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Slovenian: Opisano pri ≥ 2 % preiskovancev ter pri ≥ 1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
English: At Weeks 48 and 104, the insulin dose remained stable compared to baseline in subjects treated with dapagliflozin 10 mg at an average dose of 76 IU/day.
Slovenian: Pri preiskovancih, zdravljenih z 10 mg dapagliflozina je ostal odmerek insulina 48. in 104. teden v primerjavi z izhodiščem stabilen, povprečni odmerek je bil 76 i.e./dan.
English: Dapagliflozin + metformin
Slovenian: Parameter dapagliflozin + metformin glipizid + metformin b
English: Blood creatinine increased**,b
Slovenian: **,b povečanje sečnine v krvi
English: Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2% of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4).
Slovenian: O učinkih, povezanih s pomanjkanjem volumna (vključno s poročili o dehidraciji, hipovolemiji ali hipotenziji) so poročali pri 1,1 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,7 % oseb, ki so prejemale placebo.
English: For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78% and 0.02% adjusted mean change from baseline for 10 mg and placebo, respectively).
Slovenian: V študiji dodatka k metforminu se je zmanjšanje HbA1c ohranilo do 102. tedna (prilagojena povprečna sprememba od izhodišča -0,78 % z 10 mg dapagliflozina in 0,02 % s placebom).
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32% for dapagliflozin and -0.14% for glipizide.
Slovenian: 104. teden je bila prilagojena povprečna sprememba HbA1c od izhodišča pri dapagliflozinu -0,32 % in pri glipizidu -0,14 %.
English: Urinary tract infections were more frequently reported for dapagliflozin 10 mg compared to placebo in a pooled analysis up to 24 weeks (see section 4.8).
Slovenian: V kumulativni analizi so okužbe sečil v obdobju do 24 tednov pogosteje zabeležili med uporabo 10 mg dapagliflozina kot med uporabo placeba (glejte poglavje 4.8).
English: Tabulated list of adverse reactions
Slovenian: Pregledni seznam neželenih učinkov
English: Do not drive or use any tools or machines, if you feel dizzy taking Forxiga.
Slovenian: Če med jemanjem zdravila Forxiga občutite omotico, ne vozite in ne uporabljajte orodij ali strojev.
English: Results at Week 24 (LOCFa) of a placebo-controlled study of dapagliflozin as monotherapy
Slovenian: Rezultati s placebom kontrolirane študije dapagliflozina kot monoterapije po 24 tednih (LOCF
English: Not applicable.
Slovenian: Ni posebnih zahtev.
English: Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets dapagliflozin
Slovenian: Forxiga 5 mg filmsko obložene tablete Forxiga 10 mg filmsko obložene tablete dapagliflozin
English: Bone mineral density measurements in patients with normal or mildly impaired renal function did not indicate bone loss over a treatment period of two years.
Slovenian: Poročali so o majhnih povečanjih vrednosti PTH v serumu, ki so bila izrazitejša pri preiskovancih z večjo izhodiščno koncentracijo PTH. Merjenja mineralne kostne gostote pri bolnikih z normalno ali blago okvaro ledvic v dveletnem obdobju zdravljenja niso pokazala izgube kostne mase.
English: Mean changes from baseline in haematocrit were 2.30% for dapagliflozin 10 mg versus -0.33% for placebo.
Slovenian: Povprečni odstotek spremembe hematokrita od izhodišča je bil 2,30 % z 10 mg dapagliflozina in -0,33 % s placebom.
English: HbA1c < 7%
Slovenian: HbA1c < 7 % (LOCF)
English: NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB
Slovenian: Imetnik dovoljenja za promet z zdravilom AstraZeneca AB
English: Diuretics
Slovenian: Dojenje
English: Use in patients with hepatic impairment
Slovenian: Uporaba pri bolnikih z okvaro jeter
English: Dapagliflozin 10 mg
Slovenian: Monoterapija dapagliflozin 10 mg placebo b
English: Add-on combination therapy
Slovenian: Dodatek h kombiniranemu zdravljenju
English: In an add-on to insulin study, episodes of major hypoglycaemia were reported in 0.5% and 1.0% of subjects treated with dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5% of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
Slovenian: V študiji dodatka k insulinu so hude hipoglikemije do 24. oziroma 104. tedna zabeležili pri 0,5 % oziroma 1,0 % prejemnikov kombinacije 10 mg dapagliflozina in insulina ter pri 0,5 % prejemnikov kombinacije placeba in insulina.
English: Use in patients with renal impairment
Slovenian: Uporaba pri bolnikih z okvaro ledvic
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350
Slovenian: Filmska obloga polivinilalkohol (E1203) titanov dioksid (E171) makrogol 3350 smukec (E553b) železov oksid, rumeni (E172)
English: • Your doctor may start you on a 5 mg dose if you have a liver problem.
Slovenian: • Če imate težave z jetri, vam zdravnik lahko predpiše začetni odmerek 5 mg.
English: adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7% and 0.8% of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Slovenian: Pri osebah, starih ≥ 65 let, so o pomanjkanju volumna kot neželenemu učinku, najpogosteje poročali kot o hipotenziji in jo zabeležili pri 1,7 % oseb, ki so prejemale dapagliflozin in pri 0,8 % oseb, ki so prejemale placebo (glejte poglavje 4.4).
English: (95% CI) Subjects (%) achieving: HbA1c < 7% (LOCF)d Adjusted for baseline Body weight (kg) (LOCF)d Baseline (mean) Change from baselinec Difference from placeboc (95% CI) 1glimepiride 4 mg/day; 2Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrollment.
Slovenian: 2Metformin (oblike s takojšnjim ali podaljšanim sproščanjem) ≥ 1500 mg/dan ter največji tolerirani odmerek (ki mora biti vsaj polovičen maksimalni odmerek) sulfonilsečnine vsaj 8 tednov pred zajetjem v študijo.
English: LIST OF EXCIPIENTS Contains lactose.
Slovenian: Zdravilo Forxiga vsebuje laktozo
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
English: The mean change from baseline in HbA1c at 24 weeks was -0.44% and -0.33%, for dapagliflozin 10 mg and placebo, respectively.
Slovenian: Povprečna sprememba HbA1c od izhodišča za 10 mg dapagliflozina je bila 24. teden -0,44 % in -0,33 % za placebo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
English: Each Forxiga 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Slovenian: Ena tableta zdravila Forxiga 5 mg filmsko obložene tablete vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
English: • dry mouth
Slovenian: • suha usta
English: Stop taking Forxiga and see a doctor as soon as possible if you notice any of the following serious side effects:
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, prenehajte z jemanjem zdravila Forxiga in čim prej obiščite zdravnika:
English: • dizziness
Slovenian: • omotica
English: Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Slovenian: Puh/Tel: +358 10 23 010
English: • genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
Slovenian: • okužba spolovil (glivice) na spolnem udu ali v nožnici (med znaki so lahko draženje, srbenje,
English: Each Forxiga 10 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Slovenian: Ena tableta zdravila Forxiga 10 mg filmsko obložene tablete vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
English: Contact your doctor as soon as possible if you have any of the following side effects:
Slovenian: Čim prej se posvetujte z zdravnikom, če imate katerega od naslednjih neželenih učinkov: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
English: Evidence of sustained glucose excretion was seen in subjects with type 2 diabetes mellitus given dapagliflozin 10 mg/day for up to 2 years.
Slovenian: Pri osebah s sladkorno boleznijo tipa 2, ki so prejemale 10 mg dapagliflozina na dan, do 2 leti, so ugotovili ohranjeno izločanje glukoze.
English: Dizziness
Slovenian: Malignomi
English: Results at Week 52 (LOCFa) in an active-controlled study comparing dapagliflozin to glipizide as add-on to metformin
Slovenian: Rezultati z zdravilno učinkovino kontrolirane študije, ki je primerjala dapagliflozin z glipizidom kot dodatkom k metforminu po 52 tednih (LOCF
English: Talk to your doctor if you would like to or are breast-feeding before taking this medicine.
Slovenian: Če dojite ali želite dojiti, se posvetujte z zdravnikom pred jemanjem tega zdravila.
English: • Keep this medicine out of the sight and reach of children.
Slovenian: • Zdravilo shranjujte nedosegljivo otrokom!
English: • Forxiga 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm.
Slovenian: • Tablete zdravila Forxiga 5 mg filmsko obložene tablete so rumene barve, okrogle oblike s premerom 0,7 cm. Na eni strani imajo vtisnjeno oznako "5" in na drugi strani "1427".
English: (95% CI) Mean daily insulin dose (IU)1
Slovenian: Razlika glede na placebo (95 % IZ) Povprečni dnevni odmerek insulina (i.e.) Izhodišče (povprečje) Sprememba od izhodišča c
English: Increases in the amount of glucose excreted in the urine were observed in healthy subjects and in subjects with type 2 diabetes mellitus following the administration of dapagliflozin.
Slovenian: Pri zdravih osebah in osebah s sladkorno boleznijo tipa 2 se je po uporabi dapagliflozina povečala količina glukoze, izločene z urinom.
English: How to store Forxiga
Slovenian: Shranjevanje zdravila Forxiga
English: Na
Slovenian: i
English: Nocturia** Renal impairment**,b
Slovenian: *,f nikturija okvara ledvic
English: Parameter
Slovenian: Odmerjanje
English: • weight decreased
Slovenian: • zmanjšanje telesne mase
English: HbA1c (%) Baseline (mean) Change from baselinec
Slovenian: HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča
English: (95% CI) Subjects with mean daily insulin dose reduction of at least 10% (%) LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Slovenian: Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost in prisotnost peroralnega antidiabetika Vrednost p < 0,0001 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Vrednost p < 0,05 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Povečevanje insulinske sheme (vključno s kratkodelujočim, srednjedolgodelujočim in bazalnim insulinom) je bilo dovoljeno le, če so bolniki izpolnjevali vnaprej določena merila glede glukoze v plazmi na tešče.
English: NAME OF THE MEDICINAL PRODUCT Forxiga 10 mg tablets dapagliflozin
Slovenian: Forxiga 10 mg tablete dapagliflozin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5 mg
Slovenian: NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI 5 mg
English: Volume depletion
Slovenian: Pomanjkanje volumna
English: EU/1/12/795/008 98 film-coated tablets
Slovenian: EU/1/12/795/008 98 filmsko obloženih tablet
English: EU/1/12/795/007 28 film-coated tablets
Slovenian: EU/1/12/795/007 28 filmsko obloženih tablet
English: EU/1/12/795/002 28 film-coated tablets
Slovenian: EU/1/12/795/002 28 filmsko obloženih tablet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10 mg
Slovenian: NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI 10 mg
English: EU/1/12/795/001 14 film-coated tablets
Slovenian: EU/1/12/795/001 14 filmsko obloženih tablet
English: EU/1/12/795/003 98 film-coated tablets
Slovenian: EU/1/12/795/003 98 filmsko obloženih tablet
English: (95% CI) LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medication during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo § Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Slovenian: Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost Vrednost p < 0,0001 v primerjavi s placebom Ni ocenjeno za statistično značilnost zaradi postopka zaporednega preskušanja za sekundarne opazovane dogodke
English: Back pain*
Slovenian: • bolečine v hrbtu
English: NAME OF THE MEDICINAL PRODUCT Forxiga 10 mg film-coated tablets
Slovenian: Forxiga 10 mg filmsko obložene tablete
English: EU/1/12/795/006 14 film-coated tablets
Slovenian: EU/1/12/795/006 14 filmsko obloženih tablet
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Slovenian: Petdeset odstotkov preiskovancev je bilo izhodiščno na monoterapiji z insulinom; 50 % jih je poleg insulina jemalo 1 ali 2 peroralna antidiabetika.
English: NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg film-coated tablets
Slovenian: Forxiga 5 mg filmsko obložene tablete
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo.
English: 2Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Slovenian: Med slednjimi jih je 80 % jemalo samo metformin, 12 % jih je jemalo metformin in sulfonilsečnino, preostali pa so uporabljali druge peroralne antidiabetike.
English: Uncommon**
Slovenian: **,b
English: (95% CI) Body weight (kg) Baseline (mean) Change from baselinec Difference from placeboc
Slovenian: (95 % IZ) Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča c
English: NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg tablets dapagliflozin
Slovenian: Forxiga 5 mg tablete dapagliflozin
English: Forxiga contains lactose
Slovenian: Vsebuje laktozo.
English: Your doctor may want to lower the dose of these other medicines,
Slovenian: Zdravnik vam bo morda zmanjšal odmerek teh drugih zdravil, da bi preprečil prekomerno zmanjšanje količine sladkorja v vaši krvi (hipoglikemijo).
English: Each tablet contains 50 mg of lactose anhydrous.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 50 mg brezvodne laktoze.
English: Vulvovaginitis, balanitis and related genital infections*,b,c Urinary tract infection*,b,d
Slovenian: Infekcijske in parazitske bolezni vulvovaginitis, balanitis in sorodne okužbe spolovil
English: Renal and urinary disorders
Slovenian: Glukoza v urinu
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE 10 mg
Slovenian: PERFORIRANI PRETISNI OMOTI ZA POSAMEZNI ODMEREK 10 mg
English: AstraZeneca S.p.A. Tel: +39 02 9801 1
Slovenian: Tel: +39 02 9801 1
English: Pruritus genital
Slovenian: Delovanje ledvic
English: Each tablet contains 25 mg of lactose anhydrous.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 25 mg brezvodne laktoze.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE 5 mg
Slovenian: PERFORIRANI PRETISNI OMOTI ZA POSAMEZNI ODMEREK 5 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Slovenian: Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
English: Hepatic impairment
Slovenian: Okužbe sečil
English: Your body can also make too much sugar.
Slovenian: Vaše telo lahko izdela tudi preveč sladkorja.
English: A risk to newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojenčke/otroke ne moremo izključiti.
English: • about what you can do to prevent dehydration
Slovenian: • kaj lahko storite, da boste preprečili dehidracijo
English: • Try to take it at the same time each day.
Slovenian: • Poskušajte jemati tableto vsak dan ob istem času.