FrancophonIA/ELRC3.0 huggingface dataset:
English: Vokanamet must not be used in patients with moderate or severe renal impairment (eGFR < 60 mL/min/1.73m2 or CrCl < 60 mL/min) due to the active substance metformin (see sections 4.3, 4.4 and 5.2).
Slovenian: Bolniki z zmerno oziroma hudo okvaro ledvic (z ocenjeno glomerulno filtracijo < 60 ml/min/1,73 m2 ali z očistkom kreatinina < 60 ml/min) ne smejo uporabljati zdravila Vokanamet, ker vsebuje zdravilno učinkovino metformin (glejte poglavja 4.3, 4.4 in 5.2).
English: Patients (%) achieving HbA1c < 7% 19.8b
Slovenian: N/Ac bolniki (%), ki so dosegli HbA1c < 7% 19,8
English: A dedicated study demonstrated that co-administration of canagliflozin 50 mg and 150 mg dosed twice daily as dual therapy with metformin produced clinically and statistically significant results relative to placebo in glycemic control, including HbA1c, the percentage of patients achieving HbA1c < 7%, change from baseline FPG, and in reductions in body weight as shown in table 4.
Slovenian: V usmerjeni študiji so dokazali, da je sočasna uporaba kanagliflozina v odmerku 50 mg oziroma 150 mg dvakrat na dan v okviru dvotirnega zdravljenja z metforminom povzročila klinično pomembne in statistično značilne rezultate nadzora glikemije v primerjavi s placebom, vključno z odstotkom bolnikov, ki so dosegli HbA1c < 7%, spremembo koncentracije glukoze na tešče od izhodiščne vrednosti in zmanjšanjem telesne mase, kot je prikazano v preglednici 4.
English: When Vokanamet is used as add-on therapy with insulin or an insulin secretagogue (e.g., a sulphonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Slovenian: Pri uporabi zdravila Vokanamet kot dodatnega zdravila k insulinu ali spodbujevalcu izločanja insulina (na primer sufonilsečnini) je treba za zmanjšanje tveganja za hipoglikemijo razmisliti o znižanju odmerka insulina oziroma spodbujevalca izločanja insulina (glejte poglavji 4.5 in 4.8).
English: Triple therapy with metformin and sulphonylurea (26 weeks)
Slovenian: Trotirno zdravljenje z metforminom in s sulfonilsečnino (26 tednov)
English: The level of digoxin or digitoxin in your blood may need to be checked if taken with Vokanamet.
Slovenian: Če v času zdravljenja z zdravilom Vokanamet jemljete digoksin oziroma digitoksin, bo treba izmeriti njuni koncentraciji v krvi
English: Due to volume depletion, generally small mean decreases in eGFR were seen within the first 6 weeks of treatment initiation with canagliflozin.
Slovenian: Zaradi hipovolemije so v prvih 6 tednih po začetku zdravljenja s kanagliflozinom opazili večinoma majhno povprečno zmanjšanje ocenjene glomerulne filtracije.
English: Metformin Table 2 presents adverse reactions by SOC and by frequency category reported in patients who received metformin as monotherapy and that were not observed in patients receiving canagliflozin.
Slovenian: Metformin V preglednici 2 so po organskih sistemih in po kategoriji pogostnosti navedeni neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali metformin samostojno, niso pa teh neželenih učinkov opažali pri bolnikih, ki so prejemali kanagliflozin.
English: A substudy of patients with baseline HbA1c > 10% to ≤ 12% with canagliflozin as monotherapy resulted in reductions from baseline in HbA1c (not-placebo-adjusted) of -2.13% and -2.56% for canagliflozin 100 mg and 300 mg once daily, respectively.
Slovenian: Bolniki z izhodiščno ravnijo HbA1c od > 10% do ≤ 12% V podštudiji z bolniki z izhodiščno ravnijo HbA1c od > 10% do ≤ 12% so se pri monoterapiji s kanagliflozinom vrednosti HbA1c (niso bile prirejene glede na placebo) zmanjšale za -2,13% od izhodiščne vrednosti pri odmerku 100 mg enkrat na dan in za -2,56% pri odmerku 300 mg enkrat na dan.
English: Table 2 presents adverse reactions by SOC and by frequency category reported in patients who received metformin as monotherapy and that were not observed in patients receiving canagliflozin.
Slovenian: V preglednici 2 so po organskih sistemih in po kategoriji pogostnosti navedeni neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali metformin samostojno, niso pa teh neželenih učinkov opažali pri bolnikih, ki so prejemali kanagliflozin.
English: Dual therapy with metformin (26 weeks) Canagliflozin + metformin
Slovenian: Dvotirno zdravljenje z metforminom (26 tednov) kanagliflozin + metformin placebo + metformin (n = 183)
English: and -2.5% for canagliflozin 300 mg once daily in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%).
Slovenian: 300 mg kanagliflozina enkrat na dan v kombinaciji z metforminom in s sulfonilsečnino je v povprečju spremenilo telesno maso za -2,5% v primerjavi s sitagliptinom v kombinaciji z metforminom in s sulfonilsečnino (za 0,3%).
English: The combination of canagliflozin 300 mg once daily for 7 days with a single dose of digoxin 0.5 mg followed by 0.25 mg daily for 6 days resulted in a 20% increase in AUC and a 36% increase in Cmax of digoxin, probably due to inhibition of P-gp.
Slovenian: Digoksin Kombinacija kanagliflozina v odmerku 300 mg enkrat na dan, 7 dni, z enkratnim odmerkom 0,5 mg digoksina in nato z 0,25 mg digoksina na dan, 6 dni, je povzročila povečanje AUC digoksina za 20%
English: • in patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add-on therapies)
Slovenian: • pri bolnikih, pri katerih glikemija ni dovolj urejena z uporabo metformina v najvišjih odmerkih, ki jih še lahko prenašajo, skupaj z drugimi antihiperglikemičnimi zdravili, kar vključuje insulin (za razpoložljive podatke o različnih vrstah dodatnega zdravljenja glejte poglavja 4.4, 4.5 in
English: ● Moderate and severe renal impairment (patients with eGFR < 60 mL/min/1.73 m2 or
Slovenian: Bolniki z zmerno oziroma hudo okvaro ledvic (z ocenjeno glomerulno filtracijo < 60 ml/min/1,73 m2
English: Administration of iodinated contrast agent
Slovenian: Aplikacija jodiranih kontrastnih sredstev
English: Candidal balanitis or balanoposthitis was reported in 4.2% and 3.7% of male patients treated with canagliflozin 100 mg once daily and canagliflozin 300 mg once daily, respectively, compared to 0.6% in placebo-treated male patients.
Slovenian: O kandidoznem balanitisu oziroma balanopostitisu so med bolniki moškega spola poročali pri 4,2% bolnikov s 100 mg kanagliflozina enkrat na dan in pri 3,7% bolnikov s 300 mg kanagliflozina enkrat na dan v primerjavi z 0,6% bolnikov, ki so prejemali placebo.
English: Canagliflozin + metformin and sulphonylurea
Slovenian: kanagliflozin + metformin in sulfonilsečnina placebo + metformin in sulfonilsečnina
English: Tell your doctor as soon as possible if you have any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people)
Slovenian: Drugi neželeni učinki pri jemanju samo kanagliflozina: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov)
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
Slovenian: • statistično značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin 7,5 dogodka /1.000 bolnikov-let, samo dieta: 12,7 dogodka/1.000 bolnikov-let, p = 0,017;
English: • insulin or a sulphonylurea (such as glimepiride or glipizide) for diabetes - your doctor may want to reduce your dose in order to avoid your blood sugar level from getting too low (hypoglycaemia)
Slovenian: Zdravnika obvestite zlasti, če jemljete katero od naslednjih zdravil: • insulin ali sulfonilsečnino (kot sta glimepirid ali glipizid), ki se uporabljajo za zdravljenje sladkorne bolezni - zdravnik vam bo morda znižal odmerek teh zdravil, da se vam koncentracija sladkorja v krvi ne bi preveč znižala (da ne bi prišlo do hipoglikemije)
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).
Slovenian: • statistično značilno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin 11 dogodkov/1.000 bolnikov-let, samo dieta 18 dogodkov/1.000 bolnikov-let (p = 0,01).
English: 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Slovenian: Če ponovna ocena ledvične funkcije pokaže normalno delovanje ledvic se 48 ur po preiskavi zdravljenje lahko ponovno uvede (glejte poglavje 4.5).
English: Vokanamet must be discontinued prior to, or at the time of the test and not be reinstituted until
Slovenian: Zdravljenje z zdravilom Vokanamet je treba prekiniti pred preiskavo ali v času preiskave.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
Slovenian: nenadnega zmanjšanja odmerka insulina ali povečane potrebe po insulinu zaradi večjega kirurškega posega ali resne bolezni.
English: • corticosteroids (used to treat a variety of conditions, such as severe inﬂammation of the skin or in asthma) that are given by mouth, as an injection, or inhaled • beta-2 agonists (such as salbutamol or terbutaline) used to treat asthma.
Slovenian: • kortikosteroidi (zdravila, ki jih uporabljamo pri zdravljenju raznih bolezni, kot sta hudo vnetje kože ali astma), ki jih bolnik zaužije, inhalira ali prejme z injekcijo
English: ● a significant reduction of the absolute risk of any diabetesrelated complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patientyears), p=0.0034
Slovenian: • statistično značilno zmanjšanje absolutnega tveganja za katerikoli zaplet sladkorne bolezni v skupini z metforminom (29,8 dogodka/1.000 bolnikov-let) v primerjavi s skupino bolnikov, zdravljenih samo z dieto (43,3 dogodka/1.000 bolnikov-let), p = 0,0023, in v primerjavi z združeno skupino bolnikov, zdravljenih samo s sulfonilsečnino, in bolnikov, zdravljenih samo z insulinom (40,1 dogodka/1.000 bolnikov-let), p = 0,0034;
English: Sitagliptin 100 mg + metformin and sulfonylurea (N=378)
Slovenian: sitagliptin 100 mg + metformin in sulfonilsečnina
English: Cardiac failure
Slovenian: - mišični krči
English: 150 mg twice daily (N=93)
Slovenian: 150 mg dvakrat na dan (n = 93)
English: The tablet is pink, capsule-shaped, 20 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “358” on the other side.
Slovenian: Tableta s takojšnjim sproščanjem je roza, ovalna, dolga 20 mm, filmsko obložena z vtisnjeno oznako "CM" na eni in "358" na drugi strani.
English: 50 mg twice daily (N=93)
Slovenian: 50 mg dvakrat na dan (n = 93)
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)
Slovenian: • statistično značilno zmanjšanje absolutnega tveganja za celokupno umrljivost: skupina z metforminom 13,5 dogodka/1.000 bolnikov-let v primerjavi s skupino bolnikov, zdravljenih samo z dieto, 20,6 dogodka/1.000 bolnikov-let (p = 0,011) in v primerjavi z združeno skupino bolnikov, zdravljenih samo s sulfonilsečnino ali samo z insulinom, 18,9 dogodka/1.000 bolnikov-let (p = 0,021);
English: Your kidneys will be tested by a blood test before you start taking and while you are taking this medicine.
Slovenian: Preden začnete jemati to zdravilo in med jemanjem tega zdravila bo zdravnik preverjal delovanje vaših ledvic s krvno preiskavo.
English: Lactic acidosis
Slovenian: Diagnostika laktacidoze
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/850 mg film-coated tablets
Slovenian: IME ZDRAVILA Vokanamet 150 mg/850 mg filmsko obložene tablete
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172)
Slovenian: rdeči železov oksid (E172) črni železov oksid (E172)
English: Your blood sugar levels may rise if you stop taking this medicine.
Slovenian: Če prenehate jemati to zdravilo, se vam koncentracije sladkorja v krvi lahko zvišajo.
English: Avoid consumption of large amounts of alcohol, or medicines containing alcohol, when taking this medicine.
Slovenian: V času jemanja tega zdravila se izogibajte uživanju večjih količin alkohola in zdravil, ki vsebujejo alkohol, ker prevelika količina alkohola lahko poveča tveganje za kopičenje mlečne kisline v krvi (laktacidozo).
English: • cholestyramine (medicine used to reduce cholesterol levels in the blood).
Slovenian: • holestiramin (zdravilo za zniževanje koncentracije holesterola v krvi) Glejte poglavje 3 "Koliko zdravila je potrebno vzeti".
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/1000 mg film-coated tablets
Slovenian: IME ZDRAVILA Vokanamet 50 mg/1.000 mg filmsko obložene tablete
English: Nervous system disorders common
Slovenian: Bolezni živčevja pogosti motnje okušanja
English: ● Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Slovenian: 4.3 Kontraindikacije • Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: ‘shock' or breathing difficulties
Slovenian: - nepojasnjeno hujšanje - hitro dihanje
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/850 mg film-coated tablets
Slovenian: IME ZDRAVILA Vokanamet 50 mg/850 mg filmsko obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/1000 mg film-coated tablets
Slovenian: IME ZDRAVILA Vokanamet 150 mg/1.000 mg filmsko obložene tablete
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 or CrCl 30 to < 60 mL/min, the incidences were 4.8% on canagliflozin 100 mg once daily and 8.1% on canagliflozin 300 mg once daily compared to 2.6% in the control group.
Slovenian: Pri bolnikih z izhodiščno vrednostjo ocenjene glomerulne filtracije od 30 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 oziroma z očistkom kreatinina od 30 do < 60 ml/min je bila pogostnost teh neželenih učinkov 4,8% pri uporabi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/010 (20 tablets) EU/1/14/918/011 (60 tablets) EU/1/14/918/012 (180 tablets)
Slovenian: EU/1/14/918/010 (20 tablet) EU/1/14/918/011 (60 tablet) EU/1/14/918/012 (180 tablet)
English: Therefore, Vokanamet must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).
Slovenian: Če ponovna ocena ledvične funkcije pokaže normalno delovanje ledvic se 48 ur po preiskavi zdravljenje lahko ponovno uvede (glejte poglavje 4.4).
English: You may need to stop taking Vokanamet for a couple of days before and after the operation.
Slovenian: Morda boste morali za nekaj dni pred kirurškim posegom in po njem prekiniti uporabo zdravila Vokanamet
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 50 mg kanagliflozina, in 850 mg metforminijevega klorida.
English: In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 to
Slovenian: Rezultati te združene analize so pokazali večinoma večjo pogostnost teh neželenih učinkov pri bolnikih, ki so jemali diuretike Henleyeve zanke, pri bolnikih z izhodiščno vrednostjo ocenjene glomerulne filtracije od 30 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 in pri bolnikih, ki so bili stari ≥ 75 let.
English: Canagliflozin + insulin
Slovenian: kanagliflozin 300 mg +
English: Diagnosis
Slovenian: Zdravljenje
English: • in patients not adequately controlled on their maximally tolerated doses of metformin alone
Slovenian: • pri bolnikih, pri katerih glikemija ni dovolj urejena z uporabo metformina v najvišjih odmerkih,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/004 (20 tablets) EU/1/14/918/005 (60 tablets) EU/1/14/918/006 (180 tablets)
Slovenian: EU/1/14/918/004 (20 tablet) EU/1/14/918/005 (60 tablet) EU/1/14/918/006 (180 tablet)
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with Vokanamet (see sections 4.2 and 4.8).
Slovenian: (na primer sufonilsečnini) je treba za zmanjšanje tveganja za hipoglikemijo razmisliti o znižanju odmerka insulina oziroma spodbujevalca izločanja insulina (glejte poglavji 4.5 in 4.8).
English: ● in patients not adequately controlled on their maximally tolerated doses of metformin alone
Slovenian: • pri bolnikih, pri katerih glikemija s samostojno uporabo metformina v najvišjih odmerkih, ki jih še lahko prenašajo ni dovolj urejena,
English: ● in patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add-on therapies)
Slovenian: ki jih še lahko prenašajo, skupaj z drugimi antihiperglikemičnimi zdravili, kar vključuje insulin (za razpoložljive podatke o različnih vrstah dodatnega zdravljenja glejte poglavja 4.4, 4.5 in
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/007 (20 tablets) EU/1/14/918/008 (60 tablets) EU/1/14/918/009 (180 tablets)
Slovenian: EU/1/14/918/007 (20 tablet) EU/1/14/918/008 (60 tablet) EU/1/14/918/009 (180 tablets)
English: metformin and a sulphonylurea, and metformin and pioglitazone).
Slovenian: metformin in sulfonilsečnina
English: Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and
Slovenian: Po odmerjanju enkratnega s [14C] označenega peroralnega odmerka kanagliflozina zdravim osebam so
English: Baseline (mean) in kg % change from baseline (adjusted mean)
Slovenian: telesna masa izhodiščna (povprečna) vrednost v kg sprememba od izhodiščne vrednosti v % (prilagojena povprečna vrednost)
English: on canagliflozin 100 mg once daily and 8.7% on canagliflozin 300 mg once daily compared to 2.6% in the control group (see sections 4.2 and 4.4).
Slovenian: 100 mg kanagliflozina enkrat na dan in 8,1% pri uporabi 300 mg kanagliflozina enkrat na dan v primerjavi z 2,6% v kontrolni skupini.
English: In patients ≥ 75 years of age, the incidences were 4.9%
Slovenian: 65 let, 510 bolnikov pa najmanj 75 let.
English: Hypoglycaemia in add-on therapy with insulin or insulin secretagogues The frequency of hypoglycaemia was low (approximately 4%) among treatment groups, including placebo, when used as monotherapy or as an add-on to metformin.
Slovenian: vključno s skupino s placebom, pogostnost hipoglikemije majhna (približno 4%).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/001 (20 tablets) EU/1/14/918/002 (60 tablets) EU/1/14/918/003 (180 tablets)
Slovenian: EU/1/14/918/001 (20 tablet) EU/1/14/918/002 (60 tablet) EU/1/14/918/003 (180 tablet)
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: rdeči železov oksid (E172)
English: Baseline (mean) in kg % change from baseline (adjusted mean) -1.8 Difference from placebo (adjusted mean) (97.5% CI)
Slovenian: 57,1b telesna masa izhodiščna (povprečna) vrednost v kg sprememba od izhodiščne vrednosti v % (prilagojena povprečna vrednost)
English: - 150 mg/1000 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Slovenian: 150 mg/1.000 mg: makrogol 3350 polivinilalkohol smukec titanov dioksid (E171)
English: Possible signs of lactic acidosis are: - feeling sick (nausea) or being sick (vomiting) - stomach ache - severe weakness - muscle cramps - unexplained weight loss - rapid breathing - feeling cold or uncomfortable.
Slovenian: Znaki laktacidoze so lahko: - siljenje na bruhanje (navzea) ali bruhanje
English: In two 52-week active-controlled studies comparing canagliflozin to glimepiride and sitagliptin, sustained and statistically significant mean reductions in the percentage of body weight for canagliflozin as add-on therapy to metformin were -4.2% and -4.7% for canagliflozin 100 mg and 300 mg once daily, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5% for canagliflozin 300 mg once daily in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%).
Slovenian: (Cmax) in njegova AUC sta se povečevali sorazmerno z odmerkom v okviru odmerjanja od 50 mg do 300 mg. Navidezni končni razpolovni čas (t1/2) (izražen kot povprečna vrednost ± standardna deviacija) je bil 10,6 ± 2,13 ure oziroma 13,1 ± 3,28 ure pri odmerku 100 mg oziroma 300 mg. Do stanja dinamičnega ravnovesja je prišlo po 4 do 5 dneh odmerjanja 100 mg do 300 mg kanagliflozina enkrat na dan. Farmakokinetika kanagliflozina ni odvisna od časa odmerjanja, po večkratnih odmerkih 100 mg in 300 mg pa je prišlo do kopičenja kanagliflozina v plazmi v obsegu do 36%.
English: This may induce metformin accumulation which may increase the risk for lactic acidosis.
Slovenian: Intravaskularna aplikacija jodiranih kontrastnih sredstev pri radioloških preiskavah lahko povzroči odpoved ledvic, kar lahko povzroči kopičenje metformina, kar lahko poveča nevarnost razvoja laktacidoze.
English: Further information on Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Več informacij o zdravilu Xgeva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For 31 patients their disease got worse during treatment.
Slovenian: Pri 31 bolnikih se je bolezen med zdravljenjem poslabšala.
English: Prevention of bone complications
Slovenian: Preprečevanje z okostjem povezanih zapletov
English: A response to treatment was defined as elimination of at least 90% of the giant cells or no progression of the condition after 25 weeks of treatment.
Slovenian: Odziv na zdravljenje je bil opredeljen kot uničenje vsaj 90 % gigantskih celic ali nenapredovanje bolezni po 25 tednih zdravljenja.
English: What measures are being taken to ensure the safe and effective use of Xgeva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xgeva?
English: The first study involved 37 patients, 86 % of whom responded to treatment with Xgeva.
Slovenian: V prvo študijo je bilo vključenih 37 bolnikov, od katerih se jih je 86 % odzvalo na zdravljenje z zdravilom Xgeva.
English: Xgeva received a marketing authorisation valid throughout the EU on 13 July 2011.
Slovenian: Za zdravilo Xgeva je bilo 13. julija 2011 izdano dovoljenje za promet, veljavno po vsej EU.
English: About 20% of patients were able to have complete surgical removal of the cancer.
Slovenian: Pri približno 20 % bolnikov je bilo mogoče s kirurškim posegom v celoti odstraniti raka.
English: Other information about Xgeva
Slovenian: Druge informacije o zdravilu Xgeva
English: As for all medicines, data on the use of Xgeva are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xgeva stalno spremljajo.
English: This protein activates osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Slovenian: Ta beljakovina aktivira osteoklaste, tj. celice v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
English: Of the remainder, 84 were able to have less extensive surgery than previously planned.
Slovenian: Pri preostalih bolnikih so v 84 primerih opravili kirurški poseg, vendar v manjšem obsegu, kot je bilo sprva načrtovano.