FrancophonIA/ELRC3.0 huggingface dataset:
English: e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3%
Maltese: e Ksur fl-għadam kien irrappurtat f'0.7% u 0.6% għal canagliflozin 100 mg u 300 mg, rispettivamnet, meta mqabbel ma'
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)
Maltese: ● f'pazjenti fuq l-ogħla doża ta' metformin li huma jistgħu jittolleraw flimkien ma' prodotti mediċinali oħra li jbaxxu l-glukożju inkluża l-insulina, meta dawn ma jipprovdux kontroll gliċemiku xieraq (ara sezzjonijiet 4.4, 4.5, u 5.1 għal dejta disponibbli dwar terapiji differenti miżjuda m'oħrajn).
English: h Balanitis or balanoposthitis includes the terms balanitis, balanoposthitis, balanitis candida, and genital infection fungal.
Maltese: h Balanite jew balanopostite jinkludu t-termini balanite, balanopostite, balanite candida, u infezzjoni fil-ġenitali bil-fungu.
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).
Maltese: ● tnaqqis sinifikanti fir-riskju assolut ta' infart mijokardijaku: metformin 11-il każ/1,000 sena ta' pazjent, dieta waħedha 18-il każ/1,000 sena ta' pazjent, (p=0.01).
English: Surgery
Maltese: Dijuretiċi
English: respectively, compared to 1.5% for placebo.
Maltese: rispettivament, meta mqabbla ma' 1.5 % għall-plaċebo.
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.
Maltese: e Ksur fl-għadam kien irrappurtat f'0.7% u 0.6% għal canagliflozin 100 mg u 300 mg, rispettivamnet, meta mqabbel ma' 0.3% għall-plaċebo.
English: 50 mg twice daily (N = 93)
Maltese: 50 mg darbtejn kuljum (N=93)
English: b b
Maltese: 8b
English: Canagliflozin 100 mg once daily as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p < 0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
Maltese: Canagliflozin 100 mg darba kuljum bħala terapija doppja ma' metformin ipproduċa tnaqqis jixxiebah fl-HbA1c mil linja bażi u t-300 mg pproduċiet tnaqqis superjuri (p<0.05) fl-HbA1c meta mqabbla ma' glimepiride,
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/850 mg film-coated tablets
Maltese: Vokanamet 150 mg/850 mg pilloli miksijin b'rita
English: • digoxin or digitoxin (medicines used for certain heart problems).
Maltese: ● digoxin jew digitoxin (mediċini li jintużaw għal ċerti problemi tal-qalb).
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n=2,313) described above.
Maltese: Ir-reazzjonijiet avversi f'tabella 1 huma msejsa fuq analiżi kollettiva tal-erba' studji kliniċi ta' 26 ġimgħa kkontrollati bil-plaċebo (n=2,313) deskritti fuq.
English: • Swallow the tablet whole with at least a half glass of water.
Maltese: ● Ibla' l-pillola sħiħa ma' mill-anqas nofs tazza ilma.
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/850 mg film-coated tablets
Maltese: Vokanamet 50 mg/850 mg pilloli miksijin b'rita
English: 150 mg twice daily (N = 93)
Maltese: 150 mg darbtejn kuljum (N=93)
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.
Maltese: j Bidliet medji mil-linja bażi fl-ematokrit kienu 2.4% u 2.5% għal canagliflozin 100 mg u 300 mg, rispettivament, meta mqabbla ma' 0.0% għall-plaċebo.
English: m Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg,
Maltese: m Bidliet perċentwali medji mil-linja bażi fil-potassium fid-demm kienu 0.5% u 1.0% għal canagliflozin 100 mg u 300 mg,
English: Based on postmarketing experience with canagliflozin.
Maltese: kura b'canagliflozin.
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)
Maltese: EU/1/14/918/007 (20 pillola) EU/1/14/918/008 (60 pillola) EU/1/14/918/009 (180 pillola)
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)
Maltese: EU/1/14/918/004 (20 pillola) EU/1/14/918/005 (60 pillola) EU/1/14/918/006 (180 pillola)
English: In general, canagliflozin produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including glycosylated haemoglobin (HbA1c), the percentage of patients achieving HbA1c < 7%, change from baseline fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG).
Maltese: 001) b'mod kliniku u statistiku filkontroll gliċemiku, inkluż emoglobina glikosilata (HbA1c), il-perċentwal ta' pazjenti li kisbu
English: • an operation under general, spinal, or peridural anaesthetic.
Maltese: ● se tagħmel operazzjoni b'anestesija ġenerali, mis-sinsla jew peridurali.
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).
Maltese: 100 mg u 300 mg darba kuljum wasslet għal tnaqqis medju ta' -3.9 mmHg u -5.3 mmHg, rispettivament fil-pressjoni sistolika meta mqabbla mal-plaċebo (-0.1 mmHg) u effett iżgħar fuq il-pressjoni dijastolika b'bidliet medji għal canagliflozin 100 mg darba kuljum u 300 mg darba kuljum ta' -2.1 mmHg u -2.5 mmHg, rispettivament, meta mqabbla mal-plaċebo (-0.3 mmHg).
English: In a pooled analysis of clinical data, increases in canagliflozin AUC of 26% were observed in UGT1A9*1/*3 carriers and 18% in
Maltese: dejta klinika, żidiet ta' 26% fl-AUC ta' canagliflozin kienu osservati f'individwi li jkollhom
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)
Maltese: EU/1/14/918/001 (20 pillola) EU/1/14/918/002 (60 pillola) EU/1/14/918/003 (180 pillola)
English: For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg once daily and 8.8% on canagliflozin 300 mg once daily compared to 4.7% in the control group.
Maltese: Għal pazjenti fuq dijuretiċi loop, l-inċidenzi kienu 3.2% fuq canagliflozin 100 mg darba kuljum u 8.8% fuq canagliflozin 300 mg darba kuljum meta mqabbla ma' 4.7% fil-grupp ta' kontroll.
English: Microcrystalline cellulose Hypromellose
Maltese: metformin hydrochloride.
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/1000 mg film-coated tablets
Maltese: Vokanamet 150 mg/1000 mg pilloli miksijin b'rita
English: Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis, vaginal infection, vulvitis, and genital infection fungal.
Maltese: g Kandidjasi vulvovaġinali tinkludi t-termini kandidjasi vulvovaġinali, infezzjoni vulvovaġinali mikotika, vulvovaġinite, infezzjoni fil-vaġina, vulvite, u infezzjoni fil-ġenitali bil-fungu.
English: • dabigatran (blood thinner medicine that lowers the risk of blood clot formation)
Maltese: ● dabigatran (mediċina li traqqaq id-demm biex tnaqqas ir-riskju li jifforma tagħqid tad-demm)
English: Metformin partitions into erythrocytes.
Maltese: METFORMIN Kombinazzjonijijiet mhux irrakkomanadati
English: Lactic acidosis (very rare, may affect up to 1 in 10,000 people)
Maltese: Aċidożi lattika (rari ħafna, tista' taffettwa sa persuna waħda minn kull 10,000)
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/1000 mg film-coated tablets
Maltese: Vokanamet 50 mg/1000 mg pilloli miksijin b'rita
English: Balanitis or balanoposthitis includes the terms balanitis, balanoposthitis, balanitis candida, and genital infection fungal.
Maltese: h Balanite jew balanopostite jinkludu t-termini balanite, balanopostite, balanite candida, u infezzjoni fil-ġenitali bilfungu.
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Maltese: Dawn huma s-sinjali ta' ketoaċidożi tad-dijabete (ara wkoll sezzjoni 2 Twissijiet u prekawzjonijiet): żieda fil-livelli ta' “sustanzi marbuta mal-keton” fl-awrina jew fid-demm tiegħek telf ta' piż f'daqqa tħossok imdardar jew tirremetti uġigħ fl-istonku
English: Gastro-intestinal symptoms b
Maltese: Pazjenti b'indeboliment tal-fwied
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.
Maltese: Tabella 2 tippreżenta reazzjonijiet avversi skont SOC u skont il-kategorija ta' frekwenza rrappurtata f'pazjenti li rċivew metformin bħala monoterapija u li ma kinux osservati f'pazjenti li rċivew canagliflozin.
English: • Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock;
Maltese: ● Mard akut jew kroniku li jista' jikkawża nuqqas ta' provvista ta' ossiġnu lit-tessuti bħal: insuffiċjenza kardijaka jew respiratorja, infart mijokardijaku riċenti, xokk;
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).
Maltese: -5.3 mmHg, rispettivament fil-pressjoni sistolika meta mqabbla mal-plaċebo (-0.1 mmHg) u effett iżgħar fuq il-pressjoni dijastolika b'bidliet medji għal canagliflozin 100 mg darba kuljum u 300 mg darba kuljum ta' -2.1 mmHg u -2.5 mmHg, rispettivament, meta mqabbla mal-plaċebo (-0.3 mmHg).
English: Combinations requiring precautions for use
Maltese: .2 Inkompatibbiltajiet Mhux applikabbli.
English: Polyuria or Pollakiuriaf, Urinary tract infection (pyelonephritis and urosepsis have been reported postmarketing)
Maltese: ● komuni ħafna: tħossok imdardar/ra (nawsja), tirremetti, dijarea, uġigħ fl-istonku, u telf t'aptit
English: If an inducer of these UGT enzymes must be co-administered with canagliflozin, increasing the dose to Vokanamet containing 150 mg twice daily may be considered if patients are currently tolerating canagliflozin 50 mg twice daily and require additional glycaemic control (see sections 4.2 and 4.4).
Maltese: Jekk induttur ta' dawn l-enzimi UGT jkollu jingħata flimkien ma' canagliflozin, għandha titqies żieda fid-doża għal Vokanamet li fih 150 mg darbtejn kuljum jekk f'dak iż-żmien il pazjenti jkunu qed jittolleraw canagliflozin 50 mg darbtejn kuljum, u jkunu jeħtieġu kontroll gliċemiku addizzjonali (ara sezzjonijiet 4.2 u 4.4).
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni ma kinitx tipika b'żieda moderata ta' inqas minn 14 mmol/l (250 mg/dl) biss fil-valuri tal-glukożju fid-demm.
English: The mean steady-state volume of distribution (Vd) of canagliflozin following a single intravenous infusion in healthy subjects was 119 litres, suggesting extensive tissue distribution.
Maltese: Il-medja tal-volum ta' distribuzzjoni (Vd - volume of distribution) ta' canagliflozin fl-istat fiss wara infużjoni waħda fil-vina f'individwi f'saħħithom kienet 119-il litru, li tissuġġerixxi distribuzzjoni estensiva fit-tessuti.
English: The majority of genital mycotic infections were treated with topical antifungal treatments, either prescribed by a healthcare professional or self-treated while continuing therapy with Vokanamet.
Maltese: Rappurtar ta' reazzjonijiet avversi ssuspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Overall, 0.5% of male patients discontinued canagliflozin due to candidial balanitis or balanoposthitis.
Maltese: B'kollox, 0.5% tal-pazjenti rġiel waqqfu canagliflozin minħabba balanite jew balanopostite kandidjali.
English: Pharmacodynamic effects of canagliflozin
Maltese: Effetti ta' canagliflozin fuq prodotti mediċinali oħra
English: • at least annually in patients with normal renal function
Maltese: ● rari ħafna: tnaqqis fil-livelli ta' vitamina
English: In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 to
Maltese: Għal pazjenti b'eGFR minn 30 mL/min/1.73 m2 sa
English: The effect of concomitant administration of canagliflozin (a weak P-gp inhibitor) on dabigatran etexilate (a P-gp substrate) has not been studied.
Maltese: Ma kienu osservati l-ebda effetti ta' canagliflozin jew metformin fuq il-fertilità fi studji b'annimali (ara sezzjoni 5.3).
English: • cholestyramine (medicine used to reduce cholesterol levels in the blood).
Maltese: ● cholestyramine (mediċina li tintuża biex tnaqqas il-livelli tal-kolesterol fid-demm).
English: Further information on Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Aktar informazzjoni dwar Xgeva tinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Xgeva
Maltese: Informazzjoni oħra dwar Xgeva
English: Xgeva contains the active substance denosumab.
Maltese: Xgeva fih is-sustanza attiva denosumab.
English: The active substance in Xgeva, denosumab, is a monoclonal antibody which has been designed to recognise and attach to a protein called RANKL.
Maltese: Is-sustanza attiva f'Xgeva, denosumab, hija antikorp monoklonali, li tfasslet biex tagħraf u teħel ma' proteina msejħa RANKL.
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.
Maltese: Fit-tieni studju li involva 507 pazjenti, il-kura b'Xgeva evitat il-kirurġija f'madwar nofs (109 minn 225) il-grupp li fuqhom il-kirurġija kienet tirriżulta f'kumplikazzjonjiet.
English: The first study involved 37 patients, 86 % of whom responded to treatment with Xgeva.
Maltese: L-ewwel studju involva 37 pazjent, li 86 % minnhom irrispondew għall-kura b'Xgeva.
English: The third study involved 1,776 patients with advanced solid tumours in various parts of the body or with multiple myeloma (a cancer of the bone marrow).
Maltese: It-tielet studju involva 1,776 pazjent b'tumuri solidi avvanzati f'diversi partijiet tal-ġisem jew b'majeloma multipla (kanċer tal-mudullun).
English: The first study involved 2,046 patients with breast cancer and the second study involved 1,901 men with prostate cancer which did not respond to hormonal treatment.
Maltese: L-ewwel studju involva 2,046 pazjent bil-kanċer tas-sider u t-tieni studju involva 1,901 raġel bil-kanċer tal-prostata li ma rrispondewx għall-kura ormonali.
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.
Maltese: Rispons għall-kura ġie ddefinit bħala eliminazzjoni ta' mill-inqas 90 % taċ-ċelluli ġganteski jew li ma kienx hemm progressjoni tal-kundizzjoni wara 25 ġimgħa ta' kura.
English: What are the risks associated with Xgeva?
Maltese: X'inhuma r-riskji assoċjati ma' Xgeva?
English: About 20% of patients were able to have complete surgical removal of the cancer.
Maltese: Madwar 20 % tal-pazjenti seta' jkollhom tneħħija kompleta tal-kanċer permezz ta' kirurġija.
English: The most common side effects with Xgeva (seen in more than 1 patient in 10) are hypocalcaemia (low levels of calcium in the blood), pain in the muscles and bones, dyspnoea (difficulty breathing) and diarrhoea.
Maltese: L-effetti sekondarji l-aktar komuni b'Xgeva (osservati f'aktar minn pazjent 1 minn 10) huma ipokalċimija (livelli baxxi ta' kalċju fid-demm), uġigħ fil-muskoli u fl-għadam, dispnea (tbatija biex tieħu nifs) u dijarea.
English: Xgeva received a marketing authorisation valid throughout the EU on 13 July 2011.
Maltese: Xgeva rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-13 ta' Lulju 2011.
English: In another study involving 1,718 patients with newly diagnosed multiple myeloma, Xgeva was as effective as zoledronic acid in delaying the patients' first skeletal-related event.
Maltese: Fi studju ieħor li involva 1,718-il pazjent b'majeloma multipla dijanjostikata reċentement, Xgeva kien effettiv daqs l-aċidu żoledroniku biex jittardja l-ewwel avveniment relatat mal-iskeletru tal-pazjenti.
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.
Maltese: Fil-pazjenti b'tumur fl-għadam b'ċelluli ġganteski, il-possibilità ta' tneħħija kompleta tat-tumur b'kirurġija wara l-kura u t-tnaqqis fl-ammont ta' kirurġija f'xi pazjenti kienu kkunsidrati klinikament importanti.
English: How is Xgeva used?
Maltese: Kif jintuża Xgeva?
English: This protein activates osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Maltese: Din il-proteina tattiva l-osteoklasti, iċ-ċelloli fil-ġisem li huma involuti fit-tkissir tat-tessut tal-għadam.
English: In these studies, Xgeva reduced the risk of developing a first skeletal-related event by 18% compared with zoledronic acid.
Maltese: F'dawn l-istudji, Xgeva naqqas ir-riskju li jiżviluppa l-ewwel avveniment relatat mal-iskeletru bi 18 % meta mqabbel mal-aċidu żoledroniku.
English: To prevent bone complications in cancer that has spread to the bone, 120 mg is given once every 4 weeks as a single injection under the skin in the thigh, abdomen (belly) or upper arm.
Maltese: Biex jiġu pprevenuti kumplikazzjonijiet fl-għadam f'kanċer li jkun infirex lejn l-għadam, darba kull 4 ġimgħat jingħataw 120 mg bħala injezzjoni waħda taħt il-ġilda fil-koxxa, l-addome (iż-żaqq) jew filparti ta' fuq tad-driegħ.
English: Other common side effects (seen in up to 1 patient in 10) are development of another form of cancer in patients with advanced cancer, hypophosphataemia (low levels of phosphate in the blood), excessive sweating, tooth loss and osteonecrosis in the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth and loose teeth).
Maltese: fosfat fid-demm), għaraq eċċessiv, telf ta' snien u osteonekrożi fix-xedaq (ħsara fl-għadam tax-xedaq, li jistgħu jwasslu għal uġigħ, feriti fil-ħalq u snien laxki).
English: In patients with giant cell tumour of bone, Xgeva was effective in controlling the disease.
Maltese: F'pazjenti b'tumur fl-għadam b'ċelluli ġganteski, Xgeva kien effettiv biex jikkontrolla l-marda.
English: The cells in giant cell tumour of bone are also activated via RANKL, and treatment with denosumab prevents them from growing and breaking down bone, allowing normal bone to replace the tumour.
Maltese: Iċ-ċelluli fit-tumur fl-għadam b'ċelluli ġganteski huma attivati wkoll permezz ta' RANKL, u l-kura b'denosumab tipprevjeni milli dawn jikbru u jkissru l-għadam, u tippermetti lill-għadam normali sabiex jissostitwixxi t-tumur.
English: Xgeva was compared with zoledronic acid (another medicine used to prevent bone complications) in four main studies in patients with different types of cancer which had spread to the bone.
Maltese: Xgeva tqabbel mal-aċidu żoledroniku (mediċina oħra użata fil-prevenzjoni tal-kumplikazzjonijiet flgħadam) f'erba' studji ewlenin fuq pazjenti b'tipi differenti ta' kanċer li nfirex lejn l-għadam.
English: These complications include fractures (breaks in the bone), spinal compression (pressure on the spinal cord caused by damage to the surrounding bone), or bone problems requiring radiotherapy (treatment with radiation) or surgery.
Maltese: Dawn il-kumplikazzjonijiet jinkludu fratturi (ksur fl-għadam), kompressjoni tal-ispina dorsali (pressjoni fuq l-ispina dorsali kkawżata minn ħsara għall-għadma talmadwar), jew problemi fl-għadam li jeħtieġu r-radjoterapija (kura bir-radjazzjoni) jew kirurġija.
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.
Maltese: Fil-pazjenti b'tumur fl-għadam b'ċelluli ġganteski, 120 mg jiġu injettati taħt il-ġilda darba fil-ġimgħa għal 3 ġimgħat, u mbagħad darba kull 4 ġimgħat.
English: Of the remainder, 84 were able to have less extensive surgery than previously planned.
Maltese: Mill-bqija, 84 setgħu jgħaddu minn kirurġija inqas estensiva minn kemm kien ippjanat qabel.
English: How does Xgeva work?
Maltese: X'inhu Xgeva u għal xiex jintuża?
English: In this study, Xgeva reduced the risk of developing a first skeletal-related event by 16% compared with zoledronic acid.
Maltese: F'dan l-istudju, Xgeva naqqas ir-riskju li jiżviluppa l-ewwel avveniment relatat mal-iskeletru b'16 % meta mqabbel mal-aċidu żoledroniku.
English: As for all medicines, data on the use of Xgeva are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Xgeva hija ssorveljata kontinwament.
English: Two main studies looked at the effect of Xgeva in adults or full-grown adolescents with giant cell tumour of bone that was unsuitable for surgery or in whom surgery would have resulted in severe complications like amputation of a limb.
Maltese: Żewġ studji ewlenin ħarsu lejn l-effett ta' Xgeva f'adulti jew f'adolexxenti li jkunu kibru għalkollox b'tumur flgħadam b'ċelluli ġganteski li ma kinux xierqa għal kirurġija jew li fuqhom, il-kirurġija kienet tirriżulta f'kumplikazzjonijiet severi bħal amputazzjoni ta' riġel.
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.
Maltese: Xgeva ma għandux jintuża f'pazjenti li jkollhom feriti minn interventi kirurġiċi dentali jew fil-ħalq li jkunu għadhom ma fiequx, jew f'nies b'ipokalċimija severa u mhux ikkurata.
English: The Agency considered that Xgeva was effective in preventing bone-related events and was less toxic to the kidneys and easier to use than existing treatments.
Maltese: L-Aġenzija kkunsidrat li Xgeva kien effettiv fil-prevenzjoni ta' avvenimenti relatati mal-għadam u kien inqas tossiku għall-kliewi u aktar faċli li jintuża minn kuri eżistenti.
English: Why is Xgeva authorised in the EU?
Maltese: Għaliex Xgeva ġie awtorizzat fl-UE?
English: EMA/828729/2009
Maltese: 17 ta' Diċembru 2009 EMA/828729/2009
English: It contains the active substance thrombin alfa.
Maltese: Fih is-sustanza attiva thrombin alfa.
English: 17 December 2009 EMA/828729/2009 EMEA/H/C/1063
Maltese: EMEA/H/C/1063
English: What is Recothrom?
Maltese: X'inhu Recothrom?
English: The active substance in Recothrom, thrombin alfa, is a copy of thrombin, a protein that is found naturally in the blood.
Maltese: Is-sustanza attiva f'Recothrom, thrombin alfa, hija kopja tat-trombina, proteina li tinsab b'mod naturali fid-demm.