FrancophonIA/ELRC3.0 huggingface dataset:
English: • upper respiratory tract infection,
Maltese: • infezzjoni fl-apparat respiratorju ta' fuq,
English: Prolia demonstrated a 40% relative reduction (0.5% absolute risk reduction) in the risk of hip fracture over 3 years (p < 0.05).
Maltese: Prolia wera tnaqqis relattiv ta' 40% (tnaqqis assolut tar-riskju ta' 0.5%) fir-riskju ta' ksur tal-ġenbejn fuq perjodu ta' 3 snin (p < 0.05).
English: Calcium and Vitamin D supplementation
Maltese: Supplimentazzjoni ta' Kalċju u Vitamina D
English: Incidence of ONJ was 0.04% at 3 years, 0.06% at 5 years and 0.44% at 10 years of Prolia treatment.
Maltese: L-inċidenza ta' ONJ kienet ta' 0.04% wara 3 snin, 0.06% wara 5 snin u 0.44% wara 10 snin ta' trattament bi Prolia.
English: No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (GFR < 30 ml/min).
Maltese: M'hemm l-ebda data disponibbli f'pazjenti b'terapija sistemika ta' glukokortikojd fit-tul u indeboliment renali sever (GFR < 30 mL/min).
English: Examples of the clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (see section 4.4).
Maltese: Eżempji tal-manifestazzjonijiet kliniċi ta' ipokalċimija sintomatika severa inkludew titwil tal-intervall QT, tetanja, aċċessjonijiet u stat mentali mibdul (ara sezzjoni 4.4).
English: Age (28-87 years), race and disease state (low bone mass or osteoporosis; prostate or breast cancer) do not appear to significantly affect the pharmacokinetics of denosumab.
Maltese: L-età (28-87 sena), razza u stat tal-marda (massa tal-għadam baxxa jew osteoporożi; kanċer tal-prostata jew tas-sider) ma jidhirx li jaffettwaw il-farmakokinetika ta' denosumab b'mod sinifikanti.
English: The following convention has been used for the classification of the adverse reactions (see table 1): very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-konvenzjoni li ġejja ntużat għall-klassifikazzjoni tar-reazzjonijiet avversi (ara tabella 1): komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Skin infections reported as serious adverse reactions were similar in the placebo (0.6%, 5 out of 845) and the Prolia (0.6%, 5 out of 860) groups in the breast and prostate cancer studies.
Maltese: Infezzjonijiet fil-ġilda rrappurtati bħala reazzjonijiet avversi serji kienu simili fil-gruppi ta' plaċebo (0.6%, 5 minn 845) u l-gruppi ta' Prolia (0.6%, 5 minn 860) fl-istudji dwar kanċer tas-sider u talprostata.
English: Open-label extension study in the treatment of postmenopausal osteoporosis A total of 4,550 women (2,343 Prolia & 2,207 placebo) who missed no more than one dose of investigational product in the pivotal study described above and completed the month 36 study visit agreed to enrol in a 7-year, multinational, multicentre, open-label, single-arm extension study to evaluate the long-term safety and efficacy of Prolia.
Maltese: Studju ta' estensjoni open-label fit-trattament ta' osteoporożi ta' wara l-menopawsa Total ta' 4,550 mara (2,343 Prolia & 2,207 plaċebo) li qabżu mhux aktar minn doża waħda tal-prodott li kien qed jiġi nvestigat fl-istudju pivitali deskritt fuq u temmew il-vista tal-istudju ta' xahar 36 qablu li jinkitbu fi studju ta' estensjoni ta' 7 snin, multinazzjonali, multiċentriku, open-label, bi grupp wieħed biex jiġu evalwati s-sigurtà u l-effikaċja fit-tul ta' Prolia.
English: Prolia demonstrated a significant relative risk reduction of new vertebral fractures: 85% (1.6% absolute risk reduction) at 1 year, 69% (2.2% absolute risk reduction) at 2 years and 62% (2.4% absolute risk reduction) at 3 years (all p < 0.01).
Maltese: Prolia wera tnaqqis sinifikanti fir-riskju relattiv ta' ksur vertebrali ġdid: 85% (tnaqqis fir-riskju assolut ta' 1.6%) wara sena, 69% (tnaqqis fir-riskju assolut ta' 2.2%) wara sentejn u 62% (tnaqqis fir-riskju assolut ta' 2.4%) wara 3 snin (kollha p < 0.01).
English: No data are available on the effect of denosumab on human fertility.
Maltese: M'hemmx dejta disponibbli dwar l-effett ta' denosumab fuq il-fertilità umana.
English: Concomitant glucocorticoid treatment is an additional risk factor for hypocalcaemia.
Maltese: Trattament tal-glukokortikojd konkomitanti huwa fattur ta' riskju addizzjonali għal ipokalċimija.
English: Osteonecrosis of the jaw1
Maltese: Osteonekrosi tax-xedaq1
English: This medicine contains 47 mg sorbitol in each mL of solution.
Maltese: Din il-mediċina fiha 47 mg ta' sorbitol f'kull mL ta' soluzzjoni.
English: Relative risk reduction (%) (95% CI)
Maltese: Tnaqqis relattiv tar-riskju (%) (CI ta' 95%)
English: Maternal mammary gland development was normal.
Maltese: Żvilupp tal-glandola mammarja fl-omm kien normali.
English: Efficacy and safety of Prolia were investigated in 795 patients (70% women and 30% men) aged 20 to 94 years treated with ≥ 7.5 mg daily oral prednisone (or equivalent).
Maltese: L-effikaċja u s-sigurtà ta' Prolia kienu investigati f'795 pazjent (70% nisa u 30% irġiel) b'età ta' 20 sa 94 sena li kienu trattati b'≥ 7.5 mg ta' prednisolone orali kuljum (jew ekwivalenti).
English: In a study of 55 patients with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab.
Maltese: Fi studju fuq 55 pazjent bi gradi varji ta' funzjoni renali, inkluż pazjenti fuq dijalisi, il-grad ta' indeboliment renali ma kellu l-ebda effett fuq il-farmakokinetika ta' denosumab.
English: In clinical studies, neutralising antibodies have not been observed for denosumab.
Maltese: Fi studji kliniċi, ma kienux osservati antikorpi newtralizzanti għal denosumab.
English: Atypical femoral fractures have also been reported in patients with certain co-morbid conditions (e.g. vitamin D deficiency, rheumatoid arthritis, hypophosphatasia) and with use of certain pharmaceutical agents (e.g. bisphosphonates, glucocorticoids, proton pump inhibitors).
Maltese: Ksur mhux tipiku tal-wirk kien irrappurtat ukoll f'pazjenti b'ċertu kondizzjonijiet komorbużi (eż. defiċjenza ta' vitamina D, artrite rewmatika, ipofosfatasja) u bl-użu ta' ċertu sustanzi farmaċewtiċi (eż. bisphosphonates, glukokortikojdi, inibituri tal-pompa tal-protoni).
English: This indicates that Prolia should not alter the pharmacokinetics of medicinal products metabolised by CYP3A4.
Maltese: Dan jindika li Prolia m'għandux jibdel ilfarmakokinetika ta' prodotti mediċinali metabolizzati minn CYP3A4.
English: Efficacy and safety of Prolia administered once every 6 months for 3 years were investigated in postmenopausal women (7,808 women aged 60-91 years, of which 23.6% had prevalent vertebral fractures) with baseline bone mineral density (BMD) T-scores at the lumbar spine or total hip between -2.5 and -4.0 and a mean absolute 10-year fracture probability of 18.60% (deciles: 7.9-32.4%) for major osteoporotic fracture and 7.22% (deciles: 1.4-14.9%) for hip fracture.
Maltese: L-effikaċja u s-sigurtà ta' Prolia mogħti darba kull 6 xhur għal 3 snin kienu nvestigati f'nisa wara lmenopawsa (7,808 mara b'età ta' 60-91 sena, li fosthom 23.6% kellhom ksur vertebrali prevalenti) b'punteġġi T tad-densità tal-minerali fl-għadam (BMD - bone mineral density) fil-linja bażi fl-ispina lumbari jew ġenbejn totali ta' bejn -2.5 u -4.0 u medja assoluta ta' probabbiltà ta' ksur fuq medda ta' 10 snin ta' 18.60% (deciles: 7.9-32.4%) għall-ksur osteoporetiku maġġuri u 7.22% (deciles: 1.414.9%) għall-ksur tal-ġenbejn.
English: Prolia increased lumbar spine BMD from baseline in 94.7% of men at 1 year.
Maltese: Prolia zied BMD fl-ispina lombari mil-linja bażi f'94.7% tal-irġiel fi sena.
English: Hypocalcaemia1
Maltese: Ipokalċimija1
English: In the post-marketing setting, rare events of drug-related hypersensitivity, including rash, urticaria, facial swelling, erythema, and anaphylactic reactions have been reported in patients receiving Prolia.
Maltese: Reazzjonijiet ta' sensittività eċċessiva relatati mal-mediċina Fl-ambjent ta' wara t-tqegħid fis-suq, avvenimenti rari ta' sensittività eċċessiva relatata mal-mediċina, inkluż raxx, urtikarja, nefħa fil-wiċċ, eritema, u reazzjonijiet anafilatiċi kienu rrappurtati f'pazjenti li kienu qed jirċievu Prolia.
English: Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Maltese: Ilma għall-injezzjonijiet * Baffer tal-acetate jiġi ffurmat billi jitħallat acetic acid ma' sodium hydroxide
English: 3 Includes pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip.
Maltese: 3 Jinkludi tal-pelvi, tarf tal-wirk, tibja prossimali (qasba tas-sieq), kustilji, omeru prossimali, driegħ, u ġenbejn.
English: Prolia significantly reduced the risk of new vertebral fractures at 1, 2 and 3 years (p < 0.0001) (see table 2).
Maltese: Prolia inaqqas b'mod sinifikanti r-riskju ta' ksur vertebrali ġdid wara sena, sentejn u 3 snin (p < 0.0001) (ara tabella 2).
English: In general, monoclonal antibodies are not eliminated via hepatic metabolic mechanisms.
Maltese: B'mod ġenerali, antikorpi monoklonali mhux eliminati permezz tal-mekkaniżmi metaboliċi tal-fwied.
English: Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.
Maltese: Denosumab huwa antikorp IgG2 monoklonali uman magħmul f'linja ta' ċelluli mammiferi (ċelluli talovarju tal-ħamster Ċiniż) permezz ta' teknoloġija tat-tfassil tad-DNA.
English: • are a smoker (as this may increase the risk of dental problems).
Maltese: • tpejjep (għax dan jista' jżid ir-riskju ta' problemi dentali).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL pre-filled syringe containing 60 mg of denosumab (60 mg/mL).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa mimlija għal-lest ta' 1 mL fiha 60 mg ta' denosumab (60 mg/mL).
English: In a post-hoc analysis in women > 75 years, a 62% relative risk reduction was observed with Prolia (1.4% absolute risk reduction, p < 0.01).
Maltese: F'analiżi post-hoc f'nisa ta' > 75 sena, kien osservat tnaqqis relattiv tar-riskju ta' 62% bi Prolia (tnaqqis assolut tar-riskju ta' 1.4%, p < 0.01).
English: At 1 year, the subject incidence of new radiological vertebral fracture was 2.7% (denosumab) versus 3.2% (risedronate).
Maltese: F'sena, l-inċidenza tas-suġġett ta' ksur vertebrali radjoloġiku ġdid kienet ta' 2.7% (denosumab) versus 3.2% (risedronate).
English: Osteonecrosis of the Jaw (ONJ) ONJ has been reported rarely in patients receiving Prolia for osteoporosis (see section 4.8).
Maltese: Osteonekrosi tax-Xedaq (ONJ - Osteonecrosis of the Jaw) ONJ kienet irrappurtata b'mod rari f'pazjenti li jirċievu Prolia għall-osteoporożi (ara sezzjoni 4.8).
English: 4 Includes clinical vertebral, hip, forearm, and humerus fractures, as defined by the WHO.
Maltese: 4 Jinkludi ksur kliniku vertebrali, tal-ġenbejn, driegħ, u tal-omeru, kif definit mid-WHO.
English: Adolescent primates dosed with denosumab at 27 and 150 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
Maltese: Primati adolexxenti iddożati b'denosumab 27 u 150 darba l-esponiment kliniku (doża ta' 10 u 50 mg/kg) kellhom pjanċi tat-tkabbir (partijiet tal-għadam li qed jikbru) mhux normali.
English: • concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Maltese: • terapiji konkomitanti: kortikosterojdi, kimoterapija, inibituri tal-anġjoġenesi, radjuterapija għar ras u l-għonq.
English: Osteonecrosis of the jaw
Maltese: Osteonekrosi tax-xedaq
English: In a single phase III placebo-controlled clinical trial in patients with prostate cancer receiving ADT an imbalance in diverticulitis adverse events was observed (1.2% denosumab, 0% placebo).
Maltese: III ikkontrollata bil-plaċebo f'pazjenti b'kanċer tal-prostata li kienu qed jirċievu ADT kien osservat żbilanċ fl-avvenimenti avversi ta' divertikulite (1.2% denosumab, 0% plaċebo).
English: Two subpopulations were studied: glucocorticoid-continuing (≥ 7.5 mg daily prednisone or its equivalent for ≥ 3 months prior to study enrolment; n = 505) and glucocorticoid-initiating (≥ 7.5 mg daily prednisone or its equivalent for < 3 months prior to study enrolment; n = 290).
Maltese: Ġew studjati żewġ subpopolazzjonijiet: dawk li komplew il-glukokortikojd (≥ 7.5 mg prednisolone kuljum jew l-ekwivalenti tiegħu għal ≥ 3 xhur qabel ir-reġistrazzjoni għall-istudju; n = 505) u dawk li bdew il-glukokortikojd (≥ 7.5 mg prednisolone kuljum jew l-ekwivalenti tiegħu < 3 xhur qabel irreġistrazzjoni għall-istudju; n = 290).
English: After Cmax, serum levels declined with a half-life of 26 days (range 6-52 days) over a period of 3 months (range 1.5-4.5 months).
Maltese: Wara Cmax, il-livelli fis-serum naqsu b'half-life ta' 26 ġurnata (firxa 6-52 ġurnata) fuq perjodu ta' 3 xhur (firxa 1.5-4.5 xhur).
English: This medicine contains less than 1 mmol sodium (23 mg) per 60 mg, that is to say essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull 60 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Drug hypersensitivity1 Anaphylactic reaction1
Maltese: Sensittività eċċessiva għall-mediċina1 Reazjoni anafilatika1
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/
English: In the glucocorticoid-initiating subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at 1 year (Prolia 3.1%, risedronate 0.8%; p < 0.001) and 2 years (Prolia 4.6%, risedronate 1.5%; p < 0.001)
Maltese: Fis-subpopolazzjoni li bdiet il-glukokortikojd, Prolia wera żieda akbar fil-BMD tal-ispina lombari meta mqabbel ma' risedronate f'sena (Prolia 3.1%, risedronate 0.8%; p < 0.001) u f'sentejn (Prolia 4.6%, risedronate 1.5%; p < 0.001)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/618/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/618/001
English: In another study of cynomolgus monkeys dosed with denosumab throughout pregnancy at AUC exposures 119-fold higher than the human dose (60 mg every 6 months), there were increased stillbirths and postnatal mortality; abnormal bone growth resulting in reduced bone strength, reduced haematopoiesis, and tooth malalignment; absence of peripheral lymph nodes; and decreased neonatal growth.
Maltese: Fi studju ieħor fuq xadini cynomolgus li ngħataw denosumab matul it-tqala kollha f'esponimenti talAUC 119-il darba ogħla mid-doża tal-bniedem (60 mg kull 6 xhur), kien hemm żieda fil-frieħ imwielda mejta u fil-mortalità wara t-twelid; tkabbir mhux normali tal-għadam li rriżulta f'għadam aktar debboli, ematopoesi mnaqqsa, u allinjament ħażin tas-snien; nuqqas ta' glandoli tal-limfa periferali; u tnaqqis fit-tkabbir ta' wara t-twelid.
English: A total of 2,626 subjects (58% of the women included in the extension study i.e. 34% of the women included in the pivotal study) completed the extension study.
Maltese: Total ta' 2,626 individwu (58% tan-nisa inklużi fl-istudju ta' estensjoni, jiġifieri 34% tan-nisa inklużi fl-istudju pivitali) spiċċaw l-istudju ta' estensjoni.
English: Osteonecrosis of the external auditory canal has been reported with denosumab.
Maltese: Ġiet irrappurtata osteonekrosi tal-kanal estern tas-smigħ b'denosumab.
English: The needle cover of the pre-filled syringe contains dry natural rubber, which is a derivative of latex (see section 4.4).
Maltese: L-għatu tal-labra tas-siringa mimlija għal-lest fih lastku naturali niexef, li huwa derivat mil-latex (ara sezzjoni 4.4).
English: In women with baseline femoral neck BMD ≤ -2.5, Prolia reduced the risk of non-vertebral fracture (35% relative risk reduction, 4.1% absolute risk reduction, p < 0.001, exploratory analysis).
Maltese: F'nisa b'BMD tal-għonq tal-wirk fil-linja bażi ta' ≤ -2.5, Prolia naqqas ir-riskju ta' ksur mhux vertebrali (tnaqqis relattiv tar-riskju ta' 35%, tnaqqis assolut tar-riskju ta' 4.1%, p < 0.001, analiżi esploratorja).
English: Clinical efficacy and safety in postmenopausal women with osteoporosis
Maltese: Effikaċja klinika u sigurtà f'nisa wara l-menopawsa b'osteoporożi
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 60 mg that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull 60 mg, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: NAME OF THE MEDICINAL PRODUCT Prolia 60 mg injection denosumab
Maltese: Prolia 60 mg injezzjoni denosumab
English: Denosumab is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Maltese: Denosumab huwa magħmul biss minn aċidi amminiċi u karboidrati bħala immunoglobulina naturali u mhux probabbli li jiġi eliminat permezz ta' mekkaniżmi metaboliċi tal-fwied.
English: In phase III placebo-controlled clinical trials, the overall incidence of skin infections was similar in the placebo and the Prolia groups: in postmenopausal women with osteoporosis (placebo [1.2%, 50 out of 4,041] versus Prolia [1.5%, 59 out of 4,050]); in men with osteoporosis (placebo [0.8%, 1 out of 120] versus Prolia [0%, 0 out of 120]); in breast or prostate cancer patients receiving hormone ablation (placebo [1.7%, 14 out of 845] versus Prolia [1.4%, 12 out of 860]).
Maltese: III ikkontrollati bil-plaċebo, l-inċidenza globali ta' infezzjonijiet fil-ġilda kienet simili fil-gruppi tal-plaċebo u fil-gruppi ta' Prolia: f'nisa wara l-menopawsa b'osteoporożi (plaċebo [1.2%, 50 minn 4,041] kontra Prolia [1.5%, 59 minn 4,050]); f'irġiel b'osteoporożi (plaċebo
English: Prolia treatment rapidly reduced the rate of bone turnover, reaching a nadir for the bone resorption marker serum type 1 C-telopeptides (CTX) (85% reduction) by 3 days, with reductions maintained over the dosing interval.
Maltese: Trattament bi Prolia naqqas malajr ir-rata ta' bidla tal-għadam, li laħqet l-aktar punt baxx għallmarkatur tal-assorbiment mill-ġdid tal-għadam fis-serum, C-telopeptides tip 1 (CTX) (tnaqqis ta' 85%) fi żmien 3 ijiem, bi tnaqqis li nżamm tul l-intervall ta' dożaġġ.
English: Using a sensitive immunoassay < 1% of patients treated with denosumab for up to 5 years tested positive for non neutralising binding antibodies with no evidence of altered pharmacokinetics, toxicity, or clinical response.
Maltese: Bl-użu ta' immunoassay sensittiv < 1% tal-pazjenti ttrattatib'denosumab għall-perjodu sa 5 snin ittestjaw pożittivi għall-antikorpi mhux newtralizzanti li jeħlu bl-ebda evidenza ta' bidla fil-farmakokinetika, tossiċità, jew rispons kliniku.
English: Uncommon cases of cellulitis, rare cases of hypocalcaemia, hypersensitivity, osteonecrosis of the jaw and atypical femoral fractures (see section 4.4 and section 4.8 - description of selected adverse reactions) have been observed in patients taking Prolia.
Maltese: Każijiet mhux komuni ta' ċellulite, każijiet rari ta' ipokalċimija, sensittività eċċessiva, osteonekrosi tax-xedaq u ksur mhux tipiku tal-wirk (ara sezzjoni 4.4 u sezzjoni 4.8 - deskrizzjoni ta' reazzjonijiet avversi magħżula) ġew osservati f'pazjenti li jieħdu Prolia.
English: Symptoms of hypocalcaemia in denosumab clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps.
Maltese: Sintomi ta' ipokalċimija fi studji kliniċi b'denosumab inkludew parasteżija jew ebusija fil-muskoli, kontrazzjonijiet, spażmi u bugħawwieġ fil-muskoli.
English: Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts.
Maltese: Denosumab huwa antikorp monoklonali uman (IgG2) li jimmira u jeħel b'affinità u bi speċifiċità għolja ma' RANKL fuq il-wiċċ ta' prekursuri ta' osteoklasts u ta' osteoklasts, u jipprevjeni lattivazzjoni tar-riċettur tiegħu, RANK.
English: It is important to identify patients at risk for hypocalcaemia.
Maltese: Huwa importanti li jiġu identifikati pazjenti b'riskju ta' ipokalċimija.
English: For a 60 mg subcutaneous dose, maximum serum denosumab concentrations (Cmax) of 6 mcg/mL (range 1-17 μg/mL) occurred in 10 days (range 2-28 days).
Maltese: Għal doża taħt il-ġilda ta' 60 mg, il-konċentrazzjonijiet massimi ta' denosumab fis-serum (Cmax) ta' 6 mcg/mL (firxa 1-17 μg/mL) seħħew fi żmien għaxart ijiem (firxa 2-28 ġurnata).
English: Clinical efficacy and safety in men with osteoporosis
Maltese: Effikaċja klinika u sigurtà f'irġiel b'osteoporożi
English: Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
Maltese: Trattament ta' telf ta' għadam assoċjat ma' terapija sistemika ta' glukokortikojd fit-tul f'pazjenti adulti li għandhom riskju miżjud ta' ksur (ara sezzjoni 5.1).
English: Each 1 mL pre-filled syringe contains 60 mg of denosumab (60 mg/mL).
Maltese: Kull siringa mimlija għal-lest ta' 1 mL fiha 60 mg denosumab (60 mg/mL).
English: All women in the extension study were to receive Prolia 60 mg every 6 months, as well as daily calcium (at least 1 g) and vitamin D (at least 400 IU).
Maltese: In-nisa kollha fl-istudju ta' estensjoni kellhom jirċievu Prolia 60 mg kull 6 xhur, kif ukoll kalċju (mill-inqas 1 g) u vitamina D (millinqas 400 IU) kuljum.
English: In patients treated with Prolia for up to 10 years, BMD increased from the pivotal study baseline by 21.7% at the lumbar spine, 9.2% at the total hip, 9.0% at the femoral neck, 13.0% at the trochanter and 2.8% at the distal 1/3 radius.
Maltese: F'pazjenti ttrattati bi Prolia sa 10 snin, il-BMD żdiedet mill-linja bażi tal-istudju pivotali b'21.7% flispina lombari, b'9.2% fil-ġenbejn totali, b'9.0% fl-għonq tal-wirk, bi 13.0% fit-trochanter u bi 2.8% fid-distal 1/3 radius.
English: • poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions.
Maltese: • iġene orali fqira, mard perjodontali, dentaturi mwaħlin ħażin, storja ta' mard tas-snien,
English: • fever, vomiting and abdominal pain or discomfort (diverticulitis),
Maltese: • deni, rimettar u uġigħ jew skomdu addominali (divertikulite),
English: At 2 years, the corresponding numbers were 4.1% versus 5.8% for new radiological vertebral fractures and 5.3% versus 3.8% for non-vertebral fractures.
Maltese: F'sentejn, in-numri korrispondenti kienu 4.1% versus 5.8% għal ksur vertebrali radjoloġiku ġdid u 5.3% versus 3.8% għal ksur mhux vertebrali ġdid.
English: ONJ has been reported rarely, in 16 patients, in clinical trials in osteoporosis and in breast or prostate cancer patients receiving hormone ablation including a total of 23,148 patients (see section 4.4).
Maltese: ONJ kienet irrappurtata b'mod rari, f'16-il pazjent, fi studji kliniċi f'osteoporożi u f'pazjienti b'kanċer tas-sider u tal-prostata li qed jirċievu asportazzjoni tal-ormoni inkluż total ta' 23,148 pazjent (ara sezzjoni 4.4).
English: In two phase III placebo-controlled clinical trials in postmenopausal women with osteoporosis, approximately 0.05% (2 out of 4,050) of patients had declines of serum calcium levels (less than 1.88 mmol/l) following Prolia administration.
Maltese: III ikkontrollati bil-plaċebo f'nisa wara l-menopawsa b'osteoporożi, madwar 0.05% (2 minn 4,050) tal-pazjenti kellhom tnaqqis fil-livelli ta' kalċju fis-serum (inqas minn 1.88 mmol/l) wara l-għoti ta' Prolia.
English: Significant increases in BMD at lumbar spine, total hip, femoral neck and hip trochanter were observed by 6 months (p < 0.0001).
Maltese: Żidiet sinifikanti fil-BMD fl-ispina lumbari, l-ġenbejn totali, l-għonq tal-wirk u t-trochanter tal-ġenbejn kienu osservati minn 6 xhur (p < 0.0001).
English: BATCH NUMBER
Maltese: NUMRU TAL LOTT