FrancophonIA/ELRC3.0 huggingface dataset:
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
Estonian: ● kõikide diabeediga seotud tüsistuste absoluutse riski märkimisväärset vähenemist metformiini rühmas (29,8 juhtu 1000 patsiendiaasta kohta) võrreldes ainult dieediga (43,3 juhtu 1000 patsiendiaasta kohta, p = 0,0023) ning sulfonüüluurea kombinatsiooni ja insuliini monoteraapia rühmadega (40,1 juhtu 1000 patsiendiaasta kohta), p = 0,0034;
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
Estonian: ● kõikide diabeedist tingitud surmajuhtude absoluutse riski märkimisväärset vähenemist: metformiini rühmas 7,5 juhtu 1000 patsiendiaasta kohta, ainult dieedi puhul 12,7 juhtu 1000 patsiendiaasta kohta, p = 0,017;
English: for placebo.
Estonian: ga platseebol.
English: • too much lactic acid in your blood (lactic acidosis).
Estonian: ● liigne piimhappe sisaldus veres (laktatsidoos).
English: (E171), and iron oxide yellow (E172).
Estonian: (E171) ja kollane raudoksiid (E172).
English: • Vokanamet 50 mg/1000 mg film-coated tablets (tablets) are beige, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “551” on the other side.
Estonian: ● Vokanamet 50 mg/1000 mg õhukese polümeerikattega tabletid (tabletid) on beežid, kapslikujulised, 21 mm pikad, mille ühel küljel on pimetrükk „CM” ja teisel küljel „551”.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Estonian: Enne Vokanameti võtmist ja ravi ajal pidage nõu oma arsti, apteekri või meditsiiniõega:
English: • Vokanamet 50 mg/850 mg film-coated tablets (tablets) are pink, capsule-shaped, 20 mm in length, and debossed with “CM” on one side and “358” on the other side.
Estonian: ● Vokanamet 50 mg/850 mg õhukese polümeerikattega tabletid (tabletid) on roosad, kapslikujulised, 20 mm pikad, mille ühel küljel on pimetrükk „CM” ja teisel küljel „358”.
English: • bone fracture
Estonian: ● luumurd;
English: • cimetidine (medicine used to treat stomach problems)
Estonian: ● tsimetidiin (kasutatakse maoprobleemide raviks);
English: • Vokanamet 150 mg/1000 mg film-coated tablets (tablets) are purple, capsule-shaped, 22 mm in length, and debossed with “CM” on one side and “611” on the other side.
Estonian: ● Vokanamet 150 mg/1000 mg õhukese polümeerikattega tabletid (tabletid) on lillad, kapslikujulised, 22 mm pikad, mille ühel küljel on pimetrükk „CM” ja teisel küljel „611”.
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)
Estonian: ● üldsuremuse absoluutse riski märkimisväärset vähenemist: metformiini rühmas 13,5 juhtu 1000 patsiendiaasta kohta võrreldes ainult dieediga (20,6 juhtu 1000 patsiendiaasta kohta, p = 0,011) ning sulfonüüluurea kombinatsiooni ja insuliini monoteraapia rühmadega (18,9 juhtu 1000 patsiendiaasta kohta, p = 0,021).
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).
Estonian: Ravi tohib uuesti alustada vähemalt 48 tunni möödumisel ja ainult siis, kui neerutalitlus on analüüside põhjal hinnatud normaalseks (vt lõik 4.4).
English: Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and 9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%.
Estonian: i Keskmine protsendiline suurenemine algtasemest kanagliflosiin 100 mg ja 300 mg vs. platseebo olid vastavalt üldkolesteroolil 3,4% ja 5,2% vs. 0,9%; HDL-kolesteroolil 9,4% ja 10,3% vs. 4,0%; LDL-kolesteroolil 5,7% ja 9,3% vs.
English: • urinary tract infections
Estonian: ● kuseteede infektsioonid;
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).
Estonian: ● müokardiinfarkti absoluutse riski märkimisväärset vähenemist: metformiini rühmas 11 juhtu 1000 patsiendiaasta kohta, ainult dieedi rühmas 18 juhtu 1000 patsiendiaasta kohta (p = 0,01).
English: There is an increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition, or hepatic impairment) due to the metformin active substance of Vokanamet (see section 4.4).
Estonian: Et Vokanameti toimeaineks on metformiin (vt lõik 4.4), suurendab äge alkoholimürgistus laktatsidoosi tekke ohtu (eriti paastumise, alatoitumise või maksapuudulikkuse korral).
English: l Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and
Estonian: l Keskmine protsendiline muutus algtasemes vere uurealämmastikus oli vastavalt 17,1% ja 18,0% kanagliflosiin 100 mg ja
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/850 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Vokanamet 150 mg/850 mg õhukese polümeerikattega tabletid
English: Your kidneys will be tested by a blood test before you start taking and while you are taking this medicine.
Estonian: Neerutalitlus Enne ravi algust selle ravimiga ja ravi ajal kontrollitakse teie neere veretesti abil.
English: Based on AUC exposure, the NOEL of 30 mg/kg/day for pheochromocytomas and renal tubular tumours is approximately 4.5 times the exposure at the daily clinical dose of 300 mg. Based on preclinical and clinical mechanistic studies, Leydig cell tumours, renal tubule tumours and pheochromocytomas are considered to be rat-specific.
Estonian: 30 mg/kg päevas feokromotsütoomide ja neeru tubulaarsete kasvajate korral umbes 4,5 korda suurem kui ekspositsioon ööpäevase kliinilise annuse 300 mg korral.
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.
Estonian: ● kortikosteroidid (kasutatakse erinevate haiguste, nt raske nahapõletiku või astma, ravis), mida manustatakse suukaudselt, süstena või inhalatsiooni teel;
English: • rash or redness of the penis or foreskin (yeast infection)
Estonian: ● peenise või eesnaha lööve või punetus (seeninfektsioon);
English: • Vokanamet 150 mg/850 mg film-coated tablets (tablets) are light yellow, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “418” on the other side.
Estonian: ● Vokanamet 150 mg/850 mg õhukese polümeerikattega tabletid (tabletid) on helekollased, kapslikujulised, 21 mm pikad, mille ühel küljel on pimetrükk „CM” ja teisel küljel „418”.
English: Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 1.5% for placebo.
Estonian: k Keskmine protsendiline muutus algtasemel kreatiniinis oli vastavalt 2,8% ja 4,0% 100 mg ja 300 mg kanagliflosiinil võrreldes 1,5%-ga platseebol.
English: The tablet is beige, capsule-shaped, 21 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “551” on the other side.
Estonian: Tablett on toimeainet kiiresti vabastav, õhukese polümeerikattega, beež, kapslikujuline, 21 mm pikk, mille ühel küljel on pimetrükk „CM” ja teisel küljel „551”.
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/850 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Vokanamet 50 mg/850 mg õhukese polümeerikattega tabletid
English: ● in patients not adequately controlled on their maximally tolerated doses of metformin alone
Estonian: ● patsientidel, kelle puhul metformiini maksimaalselt talutavad annused ei taga piisavat vere glükoosisisalduse kontrolli;
English: 1 x 20 film-coated tablets 1 x 60 film-coated tablets 180 (3 x 60) film-coated tablets.
Estonian: 180 (3 x 60) õhukese polümeerikattega tabletti.
English: respectively, compared to 0.6% for placebo.
Estonian: 300 mg võrreldes 0,6% platseebol.
English: In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 to
Estonian: Ühendatud analüüsis esines lingudiureetikume saavatel patsientidel, algse eGFR-iga 30 kuni
English: Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg, compared to 1.5% for placebo.
Estonian: n Keskmine protsendiline muutus algtasemes seerumi fosfaadisisalduses oli 100 mg kanagliflosiinil 3,6% ja 300 mg kanagliflosiinil 5,1% võrreldes 1,5%-ga platseebol.
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/1000 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Vokanamet 50 mg/1000 mg õhukese polümeerikattega tabletid
English: m Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg,
Estonian: m Keskmine protsendiline muutus algtasemes vere kaaliumisisalduses oli vastavalt 0,5% ja 1,0% kanagliflosiin 100 mg ja
English: The tablet is purple, capsule-shaped, 22 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “611” on the other side.
Estonian: Tablett on toimeainet kiiresti vabastav, õhukese polümeerikattega, lilla, kapslikujuline, 22 mm pikk, mille ühel küljel on pimetrükk „CM” ja teisel küljel „611”.
English: • Do not take a double dose to make up for a forgotten dose.
Estonian: ● Ärge võtke kahekordset annust (kaht annust samal päeval), kui annus jäi eelmisel korral võtmata.
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/1000 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Vokanamet 150 mg/1000 mg õhukese polümeerikattega tabletid
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.
Estonian: Tablett on toimeainet kiiresti vabastav, õhukese polümeerikattega, roosa, kapslikujuline, 20 mm pikk, mille ühel küljel on pimetrükk „CM” ja teisel küljel „358”.
English: Each 150 mg/1000 mg tablet contains 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Estonian: - Üks 150 mg/1000 mg tablett sisaldab 150 mg kanagliflosiini ja 1000 mg metformiinvesinikkloriidi.
English: Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3% for placebo.
Estonian: e Luumurdudest teatati 100 mg ja 300 mg kanagliflosiini korral vastavalt 0,7%-l ja 0,6%-l juhtudest, platseebo korral
English: In an analysis of four 26-week, placebo-controlled studies (N=2,313), treatment with canagliflozin 100 mg and 300 mg once daily resulted in mean reductions in systolic blood pressure of -3.9 mmHg and -5.3 mmHg, respectively, compared to placebo (-0.1 mmHg) and a smaller effect on diastolic blood pressure with mean changes for canagliflozin 100 mg once daily and 300 mg once daily of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg).
Estonian: Neljas 26-nädalases platseebokontrollitud uuringus (N = 2313) põhjustas ravi 100 mg ja 300 mg kanagliflosiiniga keskmist süstoolse vererõhu langust vastavalt -3,9 mmHg ja -5,3 mmHg võrreldes platseeboga (-0,1 mmHg).
English: - 150 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Estonian: - 150 mg/850 mg tabletid: makrogool (3350), polüvinüülalkohol, talk, titaandioksiid
English: Baseline (mean) in kg % change from baseline (adjusted mean) -1.8 Difference from placebo (adjusted mean) (97.5% CI)
Estonian: Algväärtus (keskmine) kg % muutus võrreldes algväärtusega (kohandatud keskmine) Erinevus võrreldes platseeboga (kohandatud keskmine) (97,5% CI)
English: The tablet is light yellow, capsule-shaped, 21 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “418” on the other side.
Estonian: Tablett on toimeainet kiiresti vabastav, õhukese polümeerikattega, helekollane, kapslikujuline, 21 mm pikk, mille ühel küljel on pimetrükk „CM” ja teisel küljel „418”.
English: Titanium dioxide (E171)) Iron oxide yellow (E172) Iron oxide red (E172)
Estonian: Titaandioksiid (E171)) Kollane raudoksiid (E172) Punane raudoksiiid (E172)
English: Change from baseline (adjusted mean) Difference from glimepiride (adjusted mean) (95% CI)
Estonian: Muutus võrreldes algväärtusega (kohandatud keskmine) Erinevus võrreldes glimepiriidiga (kohandatud keskmine) (95% CI)
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)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/918/010 (20 tabletti) EU/1/14/918/011 (60 tabletti) EU/1/14/918/012 (180 tabletti)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks tablett sisaldab kanagliflosiinhemihüdraati koguses, mis vastab 50 mg kanagliflosiinile ja 850 mg metformiinvesinikkloriidile.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks tablett sisaldab kanagliflosiinhemihüdraati koguses, mis vastab 150 mg kanagliflosiinile ja 850 mg metformiinvesinikkloriidile.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 1000 mg of metformin hydrochloride.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks tablett sisaldab kanagliflosiinhemihüdraati koguses, mis vastab 50 mg kanagliflosiinile ja 1000 mg metformiinvesinikkloriidile.
English: j Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively,
Estonian: j Keskmine muutus algtasemel hematokritis oli vastavalt 2,4% ja 2,5% 100 mg ja 300 mg kanagliflosiinil võrreldes
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 1000 mg of metformin hydrochloride.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks tablett sisaldab kanagliflosiinhemihüdraati koguses, mis vastab 150 mg kanagliflosiinile ja 1000 mg metformiinvesinikkloriidile.
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.
Estonian: < 60 ml/min patsientidel oli esinemissagedus 4,8% 100 mg kanagliflosiini (üks kord ööpäevas) puhul ja 8,1% 300 mg kanagliflosiini (üks kord ööpäevas) puhul võrreldes 2,6%-ga kontrollrühmas.
English: • feeling thirsty
Estonian: ● kõhukinnisus;
English: Vokanamet should not be used during breast-feeding.
Estonian: Kanagliflosiini ei tohi imetamise ajal kasutada.
English: Dual therapy with metformin (26 weeks) Canagliflozin + metformin
Estonian: Efektiivsuse tulemused platseebokontrollitud kliinilistest uuringutesta Kaksikravi koos metformiiniga (26 nädalat) Kanagliflosiin + metformiin
English: Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 2.7% for placebo.
Estonian: m Keskmine protsendiline muutus algtasemes vere kaaliumisisalduses oli vastavalt 0,5% ja 1,0% kanagliflosiin 100 mg ja 300 mg võrreldes 0,6% platseebol.
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)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/918/007 (20 tabletti) EU/1/14/918/008 (60 tabletti) EU/1/14/918/009 (180 tabletti)
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)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/918/004 (20 tabletti) EU/1/14/918/005 (60 tabletti) EU/1/14/918/006 (180 tabletti)
English: • about what you can do to prevent dehydration
Estonian: ● kuidas ära hoida organismi vedelikupuudust (dehüdratsiooni);
English: Decreases in eGFR (-3.6% and -5.2%) were reported with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to the control group (-3.0%) (see sections 4.2 and 4.4).
Estonian: −3,6% ja -5,2%) võrreldes kontrollrühmaga (-3,0%) (vt lõigud 4.2 ja 4.4).
English: Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.0% for placebo.
Estonian: j Keskmine muutus algtasemel hematokritis oli vastavalt 2,4% ja 2,5% 100 mg ja 300 mg kanagliflosiinil võrreldes 0,0%
English: ● by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis
Estonian: Metformiinil on kolm erinevat toimemehhanismi: ● maksa glükoositootmise vähendamine glükoneogeneesi ja glükogenolüüsi pärssimise kaudu;
English: Baseline (mean) in kg % change from baseline (adjusted mean) -2.1 Difference from placebo (adjusted mean) (95% CI)
Estonian: Algväärtus (keskmine) kg % muutus võrreldes algväärtusega (kohandatud keskmine) Erinevus võrreldes platseeboga (kohandatud keskmine) (95% CI)
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)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/918/001 (20 tabletti) EU/1/14/918/002 (60 tabletti) EU/1/14/918/003 (180 tabletti)
English: Baseline (mean) in kg % change from baseline (adjusted mean) -4.2 Difference from glimepiride (adjusted mean) (95% CI)
Estonian: Algväärtus (keskmine) kg % muutus võrreldes algväärtusega (kohandatud keskmine) Erinevus võrreldes glimepiriidiga (kohandatud keskmine) (95% CI)
English: - 150 mg/1000 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Estonian: - 150 mg/1000 mg tabletid: makrogool (3350), polüvinüülalkohol, talk,
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Estonian: Suukaudset annusest leiti 20…30% väljaheitest mitteimendunud ravimi fraktsioonina.
English: h
Estonian: , m
English: Baseline (mean) in kg % change from baseline (adjusted mean)
Estonian: Algväärtus (keskmine) kg % muutus võrreldes algväärtusega (kohandatud keskmine)
English: Xgeva (denosumab)
Estonian: Xgeva (denosumaab)
English: Prevention of bone complications
Estonian: Luukahjustuste ennetamine
English: Further information on Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Lisateave Xgeva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Xgeva?
Estonian: Mis meetmed võetakse, et tagada Xgeva ohutu ja efektiivne kasutamine?
English: Xgeva received a marketing authorisation valid throughout the EU on 13 July 2011.
Estonian: Xgeva on saanud müügiloa, mis kehtib kogu ELis, 13. juulil 2011.
English: About 20% of patients were able to have complete surgical removal of the cancer.
Estonian: Ligikaudu 20%-l patsientidest oli võimalik vähk kirurgiliselt täielikult eemaldada.
English: What is Xgeva and what is it used for?
Estonian: Mis on Xgeva ja milleks seda kasutatakse?
English: For 31 patients their disease got worse during treatment.
Estonian: 31 patsiendil haigus ravi ajal süvenes.
English: As for all medicines, data on the use of Xgeva are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Xgeva kasutamise kohta pidevat järelevalvet.
English: In patients with giant cell tumour of bone, 120 mg is injected under the skin once a week for 3 weeks, and then once every 4 weeks.
Estonian: Hiidrakulise luukasvajaga patsientidel süstitakse 120 mg naha alla üks kord nädalas 3 järjestikusel nädalal ning seejärel iga 4 nädala järel.
English: Other information about Xgeva
Estonian: Muu teave Xgeva kohta
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xgeva have also been included in the summary of product characteristics and the package leaflet.
Estonian: Xgeva ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Side effects reported with Xgeva are carefully evaluated and any necessary action taken to protect patients.
Estonian: Xgeva kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
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.
Estonian: Ravivastuseks peeti vähemalt 90% hiidrakkude hävitamist või seisundit, mil haigus ei olnud 25-nädalase ravi järel progresseerunud.
English: The first study involved 37 patients, 86 % of whom responded to treatment with Xgeva.
Estonian: Esimeses uuringus osales 37 patsienti, kellest 86%-l tekkis Xgevaga ravivastus.
English: Xgeva contains the active substance denosumab.
Estonian: Xgeva sisaldab toimeainena denosumaabi.
English: The Agency noted that there is a need for an effective treatment for bone disease in advanced cancer, particularly for patients with kidney problems since currently available treatments can be toxic for the kidneys.
Estonian: Amet märkis, et kaugelearenenud vähi korral esinevate luukahjustuste jaoks on vaja efektiivset ravimit, eelkõige neeruprobleemidega patsientidel, sest praegu saadaolevad ravimid võivad olla neerudele toksilised.
English: It is used in patients who cannot be treated by surgery or in whom surgery is likely to cause complications.
Estonian: Ravimit kasutatakse patsientidel, keda ei saa ravida kirurgiliselt või kellel kirurgiline ravi põhjustaks tõenäoliselt kahjustusi.
English: In the second study which involved 507 patients treatment with Xgeva prevented surgery in about half (109 of 225) of the group in whom surgery would have resulted in complications.
Estonian: Teises uuringus, milles osales 507 patsienti, õnnestus Xgevaga kirurgilist ravi vältida ligikaudu pooltel (109 patsienti 225-st) nendest patsientidest, kellel kirurgiline ravi oleks põhjustanud kahjustusi.
English: For more information about using Xgeva, see the package leaflet or contact a doctor or pharmacist.
Estonian: Lisateavet Xgeva kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: What are the risks associated with Xgeva?
Estonian: Mis riskid Xgevaga kaasnevad?
English: For patients with giant cell tumour of bone the possibility of complete surgical removal of the tumour after treatment and the reduction in extent of the surgery in some patients were considered clinically important.
Estonian: Hiidrakulise luukasvajaga patsientidel peeti kliiniliselt tähtsaks võimalust kasvaja pärast ravi kirurgiliselt täielikult eemaldada ning kirurgilise ravi väiksemat ulatust teatud patsientidel.
English: The company that markets Xgeva will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they have symptoms.
Estonian: Xgeva turustaja varustab patsiendid kaardiga, milles neid teavitatakse lõualuu osteonekroosi riskist ning soovitatakse neil sümptomite tekkimisel pöörduda oma arsti poole.
English: Of the remainder, 84 were able to have less extensive surgery than previously planned.
Estonian: Ülejäänud patsientidest oli 84 patsiendile võimalik teha plaanitust väiksema ulatusega operatsioon.