FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal impairment has been observed following the administration of Aclasta (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after Aclasta administration.
Maltese: Ġie osservat indeboliment renali wara li ngħatat Aclasta (ara sezzjoni 4.8), speċjalment f'pazjenti li diġà kellhom disfunzjoni renali u riskji oħra li jinkludu età avvanzata, prodotti mediċinali konkomitanti nefrotossiċi, terapija djuretika konkomitanti (ara sezzjoni 4.5), jew deidrazzjoni li sseħħ wara l-għoti ta' Aclasta.
English: ONJ has been reported in the post-marketing setting in patients receiving Aclasta (zoledronic acid) for osteoporosis (see section 4.8).
Maltese: Kienet irrapportata ONJ f'kuntest wara t-tqegħid fis-suq f'pazjenti li jingħataw Aclasta (zoledronic acid) għall-osteoporożi (ara sezzjoni 4.8).
English: Other medicines and Aclasta
Maltese: Mediċini oħra u Aclasta
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving Aclasta (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Maltese: Ir-rata ta' każijiet avversi serji ta' fibrillazzjoni atrijali żdiedet f'pazjenti li kienu qed jirċievu Aclasta (1.3%) (51 minn 3,862) meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo (0.6%) (22 minn 3,852).
English: Before receiving Aclasta treatment, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
Maltese: Qabel ma tingħata trattament b'Aclasta, għid lit-tabib, lill-ispiżjar jew lill-infermiera tiegħek jekk - ikollok xi problemi b'ħalqek jew snienek, bħal nuqqas ta' saħħa fis-snien, mard fil-ħanek jew jekk tkun qed tippjana li taqla' xi snien; - ma tmurx għal kura dentali ta' rutina jew ilek żmien twil ma tmur għal check-up tas-snien; - tpejjep (minħabba li dan jista' jżid ir-riskju ta' problemi fis-snien); - preċedentement tkun ingħatajt trattament b'bisphosphonate (użat biex jikkura jew jipprevjeni disturbi fl-għadam); - qed tieħu mediċini msejħa kortikosterojdi (bħal prednisolone jew dexamethasone) - għandek kanċer.
English: Multipack: 5 bottles, each bottle of 100 ml.
Maltese: Soluzzjoni għall-infużjoni Pakkett multiplu: 5 fliexken, kull flixkun ta' 100 ml.
English: At month 12, a statistically significant (p<0.05) reduction in three bone turnover markers (P1NP, BSAP, NTX) was observed in the zoledronic acid group as compared to the placebo group.
Maltese: Fit-12-il xahar, deher tnaqqis sinjifikanti statistikament (p<0.05) fi tliet markaturi ta' tibdil tal-għadam (P1NP, BSAP, NTX) filgrupp mogħti zoledronic acid meta mqabbel mal-grupp mogħti l-plaċebo.
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and binding is concentration independent.
Maltese: Zoledronic acid ma jintrabatx bil-qawwa mal-proteini tal-plażma (madwar 43-55% jintrabat) u l-irbit huwa indipendenti millkonċentrazzjoni.
English: Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of Aclasta-treated patients in a large clinical trial compared to 21% of Aclasta-treated patients in the Paget's disease trials.
Maltese: Minn stima tal-laboratorju, livelli ta' kalċju taħt il-livelli tal-medda ta' referenza normali mingħajr sintomi għal mument (anqas minn 2.10 mmol/l) seħħew f'2.3% tal-pazjenti kkurati b'Aclasta fi prova klinika kbira meta mqabbla ma' 21% tal-pazjenti kkurati b'Aclasta fil-provi bil-marda ta' Paget.
English: The study was not powered to show a reduction in clinical fractures in men; the incidence of clinical fractures was 7.5% in men treated with Aclasta versus 8.7% for placebo.
Maltese: L-istudju ma kienx potenzjat biex juri tnaqqis filfratturi kliniċi fl-irġiel; l-inċidenza ta' fratturi kliniċi f'irġiel ikkurati b'Aclasta kienet 7.5% kontra 8.7% għall-plaċebo.
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Aclasta for the treatment of postmenopausal osteoporosis.
Maltese: Ritmu tal-qalb irregolari (fibrillazzjoni atrijali) dehret f'pazjenti mogħtija Aclasta għat-trattament ta' osteoporożi postmenopawżali.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml vial of Aclasta, i.e., essentially “sodium free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett ta' 100 ml Aclasta, jiġifieri huwa essenzjalment “bla sodium”.
English: A randomised, double-blind, placebo-controlled study was conducted in paediatric patients aged 5 to 17 years treated with glucocorticoids who had decreased bone mineral density (lumbar spine BMD Zscore of -0.5 or less) and a low impact/fragility fracture.
Maltese: Sar studju randomizzat, double-blind, ikkontrollat bil-plaċebo fost pazjenti pedjatriċi li kellhom bejn 5 snin u 17-il sena ttrattati bi glukokortikojdi li kellhom tnaqqis fid-densità minerali tal-għadam (punteġġ Z tal-BMD tas-sinsla lumbari ta' -0.5 jew anqas) u ksur minn impatt jew fraġilità baxxi.
English: Aclasta-treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients (p<0.0001).
Maltese: Pazjenti kkurati b'Aclasta li għandhom 'il fuq minn 75 sena wrew tnaqqis ta' 60% fir-riskju għal fratturi fl-irkiekel meta mqabbla ma' pazjenti fuq plaċebo (p<0.
English: Uncommon Insomnia
Maltese: Mhux komuni Anemija
English: Class effects
Maltese: Effetti skont il-klassi
English: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for Aclasta and 0.8% for placebo.
Maltese: Għall-każijiet serji ta' fibrillazzjoni fl-atrija miġbura flimkien il-każijiet kienu 1.3% għal Aclasta u 0.8% għal plaċebo.
English: The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) low-trauma hip fracture who were followed for an average of 2 years on study treatment (Aclasta).
Maltese: L-inċidenza tal-ksur kliniku, inkluż ksur tal-irkiekel, ksur mhux tal-irkiekel u ksur tal-ġenbejn, ġiet evalwata f'2,127 raġel u mara b'etajiet ta' bejn 50 u 95 sena (età medja ta' 74.5 sena) bi ksur riċenti (fi żmien 90 ġurnata) fil-ġenbejn bi trawma żgħira li kienu segwiti għal perjodu medju ta' sentejn fuq il-kura tal-istudju (Aclasta).
English: Bone biopsies were obtained from the iliac crest 1 year after the third annual dose in 152 post-menopausal patients with osteoporosis treated with Aclasta (N=82) or placebo (N=70).
Maltese: Bijopsiji tal-għadam inkisbu mill-iliac crest sena 1 wara t-tielet doża ta' kull sena f'152 pazjenta wara l-menopawża b'osteoporożi kkurati b'Aclasta (N=82) jew plaċebo (N=70).
English: - Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal kwalunkwe biphosphonates jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5.
Maltese: Madwar 42% tal-pazjenti kellhom punteġġ-T BMD għall-għonq talfemori taħt -2.5 u madwar 45% tal-pazjenti kellhom punteġġ-T BMD għall-għonq tal-femori 'l fuq minn -2.5.
English: The hip fracture event rate was 1.44% for Aclasta-treated patients compared to 2.49% for placebo-treated patients.
Maltese: Ir-rata tal-każijiet tal-frattura tal-ġenbejn kienet 1.44% għallpazjenti kkurati b'Aclasta meta mqabbla ma' 2.49% għall-pazjenti kkurati bi plaċebo.
English: In the intravenous infusion studies, renal tolerability of zoledronic acid was established in rats when given 0.6 mg/kg as 15-minute infusions at 3-day intervals, six times in total (for a cumulative dose that corresponded to AUC levels about 6 times the human therapeutic exposure) while five 15-minute infusions of 0.25 mg/kg administered at 2-3-week intervals (a cumulative dose that corresponded to 7 times the human therapeutic exposure) were well tolerated in dogs.
Maltese: Fi studji b'infużjoni fil-vini, l-ammont ta' zoledronic acid li jifilħu l-kliewi kienet stabbilita fil-firien meta kienu mogħtija 0.6 mg/kg bħala infużjonijiet ta' 15-il minuta b'intervalli ta' 3 ijiem, sitt darbiet b'kollox (għal doża kumulattiva li kienet tikkorrispondi għal-livelli tal-AUC ta' madwar 6 darbiet lesponiment terapewtiku fil-bniedem), filwaqt li ħames infużjonijiet ta' 15-il minuta ta' 0.25 mg/kg mogħtija f'intervalli ta' bejn ġimagħtejn u 3 ġimgħat (doża kumulattiva li kienet tikkorrispondi għal 7 darbiet l-esponiment terapewtiku fil-bniedem) kienu ttollerati sew fi klieb.
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Maltese: Majalġja, artralġja, uġigħ fl-għadam, uġigħ fid-dahar, uġigħ fit-truf Mhux komuni Uġigħ fl-għonq, ebusija muskoluskeletrika, nefħa fil-ġogi, spażmi fil-muskoli, uġigħ muskoluskeletriku fissider, uġigħ muskoluskeletriku, ebusija fil-ġogi, artrite, dgħjufija tal-muskoli
English: One ml solution contains 0.05 mg zoledronic acid (as monohydrate).
Maltese: Kull ml ta' soluzzjoni fih 0.05 mg zoledronic acid (bħala monohydrate).
English: - The other ingredients are mannitol, sodium citrate and water for injections.
Maltese: - Is-sustanzi l-oħra huma mannitol, sodium citrate u ilma għall-injezzjonijiet.
English: In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/l) following Aclasta administration.
Maltese: Fi provi kliniċi dwar l-osteoporożi, madwar 0.2% tal-pazjenti kellhom tnaqqis notevoli fil-livelli talkalċju fis-serum (anqas minn 1.87 mmol/l) wara li ngħataw Aclasta.
English: In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, Aclasta increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96% ; p<0.001).
Maltese: Fis-sottopopolazzjoni ta' pazjenti li rċevew glukokortikojdi għal aktar minn 3 xhur qabel randomisation, Aclasta żied il-BMD tas-sinsla lumbari b'4.06% versus 2.71% għal risedronate (differenza medja: 1.36%; p<0.001). Fissottopopolazzjoni ta' pazjenti li kienu rċevew glukokortikojdi għal 3 xhur jew inqas qabel randomisation, Aclasta żied il-BMD tas-sinsla lumbari b'2.60% versus 0.64% għal risedronate (differenza medja: 1.96%; p<0.001).
English: Aclasta is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Maltese: Aclasta hija kontraindikata f'pazjenti bi tneħħija tal-kreatinina < 35 ml/min (ara sezzjonijiet 4.3 u
English: At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with Aclasta as compared to the effects observed in post-menopausal women in the HORIZON-PFT study.
Maltese: Wara 24 xahar kienet osservata żieda sinifikanti simili ta' 3.6% filBMD tal-ġenb kollu għall-pazjenti kkurati b'Aclasta, meta mqabbel mal-effetti osservati f'nisa ta' wara l-menopawża fl-istudju HORIZON-PFT.
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects)
Maltese: Ġew irrappurtati każijiet rari ta' insuffiċjenza renali li teħtieġ dijaliżi u każijiet rari li kellhom riżultat fatali f'pazjenti li diġà jkollhom disfunzjoni tal-kliewi jew xi fatturi oħra ta' riskju fosthom l-età avvanzata, prodotti mediċinali nefrotossiċi konkomitanti, terapija djuretika konkomitanti jew deidrazzjoni fil-perjodu ta' wara l-infużjoni (ara l-effetti skont ilklassi f'sezzjonijiet 4.4 u 4.8)
English: Aclasta is contraindicated during breast-feeding (see section 4.3).
Maltese: Aclasta hu kontraindikat matul it-treddigħ (ara sezzjoni 4.3).
English: 1 bottle of 100 ml Component of a multipack.
Maltese: Jagħmel parti minn pakkett multiplu.
English: Treatment with Aclasta resulted in an increase in BMD of 5.4% at the total hip and 4.3% at the femoral neck over 24 months as compared to placebo.
Maltese: Il-kura b'Aclasta rriżultat f'żieda fil-BMD ta' 5.4% fil-ġenb totali u ta' 4.3% fl-għonq femorali fuq perjodu ta' 24 xahar meta mqabbel mal-plaċebo.
English: Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with Aclasta compared to placebo.
Maltese: Analiżi tat-tomografija mikrokomputata (μCT) wriet żieda fil-volum trabekulari tal-għadam u priżervazzjoni tal-arkitettura trabekulari tal-għadam f'pazjenti kkurati b'Aclasta meta mqabbla ma' plaċebo.
English: - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures, e.g. tooth extractions.
Maltese: - Nuqqas ta' iġjene fil-ħalq, mard perjodontali, dentaturi mwaħħlin ħażin, storja ta' mard dentali, proċeduri dentali invażivi, eż. qlugħ ta' snien.
English: 1 bottle contains 5 mg zoledronic acid (as monohydrate).
Maltese: Flixkun 1 fih 5 mg zoledronic acid (bħala monoidrat).
English: CARTON (WITH BLUE BOX) FOR UNIT PACK
Maltese: KARTUNA (BIL-KAXXA ĊELESTI)
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4).
Maltese: Każijiet ta' osteonekrożi tax-xedaq kienu rrappurtati, l-aktar f'pazjenti li jsofru minn kanċer ikkurati bi prodotti mediċinali li jinibixxu r-risorbiment tal-għadam, inkluż zoledronic acid (ara sezzjoni 4.4).
English: Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Maltese: Disturbi oħrajn fil-metaboliżmu tal-minerali għandhom ikunu kkurati wkoll b'mod effettiv (eż. tnaqqis fir-riserva tal-paratirojde, malassorbiment tal-kalċju mill-imsaren).
English: Relative risk reduction in fracture incidence % (CI)
Maltese: Tnaqqis relattiv tarriskju fl-inċidenza tal-frattura % (CI)
English: There was a transient increase in serum creatinine observed within 10 days in 1.8% of Aclasta-treated patients versus 0.8% of placebo-treated patients.
Maltese: Kien hemm żieda momentanja talkreatinina fis-serum fi żmien 10 ijiem f'1.8% tal-pazjenti kkurati b'Aclasta kontra 0.8% tal-pazjenti kkurati bi plaċebo.
English: • Reminder card with the following key messages: o Need to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Aclasta o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diuretic therapy o Need to infuse Aclasta slowly over a period of no less than 15 minutes o Once-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration o Need for appropriate physical activity, non-smoking and healthy diet
Maltese: • Biljett biex ifakkar b'dawn il-messaġġi essenzjali: o Il-bżonn li jsir kalkolu tat-tneħħija tal-kreatinina skont il-piż attwali tal-ġisem billi tintuża l-formula Cockcroft-Gault qabel kull trattament b'Aclasta o Il-kontraindikazzjoni f'pazjenti bi tneħħija tal-kreatinina ta' < 35 ml/min o Il-kontraindikazzjoni f'nisa tqal u li qed ireddgħu minħabba li jista' jkun teratoġeniku o Il-bżonn li tiżgura l-idratazzjoni xierqa tal-pazjent b'mod speċjali dawk li għandhom età avvanzata u dawk mogħtija terapija dijuretika o Il-bżonn li l-infużjoni ta' Aclasta tingħata bilmod fuq perjodu ta' mhux anqas minn 15-il minuta o Il-frekwenza tad-doża li tingħata darba f'sena o Li ammonti xierqa ta' kalċju u vitamina D huma rrakkomandati li jittieħdu meta tingħata Aclasta o Il-bżonn ta' attività fiżika xierqa, li ma tpejjipx u dieta tajba għas-saħħa.
English: Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Maltese: Studji fuq bhejjem b'zoledronic acid urew effetti tossikoloġiċi fissistema riproduttiva inklużi malformazzjonijiet (ara sezzjoni 5.3). Ir-riskju potenzjali fuq in-nies mhuwiex magħruf.
English: The mechanism behind the increased incidence of atrial fibrillation is unknown.
Maltese: Mhux magħruf ilmekkaniżmu taż-żieda fil-fibrillazzjoni atrijali.
English: This resulted in exaggerated pharmacological effects considered related to the compound's inhibition of skeletal calcium mobilisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Maltese: Dan irriżulta f'effetti farmakoloġiċi esaġerati kkunsidrati bħala relatati malinibizzjoni tat-taħlita tal-mobilizzazzjoni skeletrika tal-kalċju, li rriżultat f'ipokalċimija fiż-żmien tattwelid, effet tal-klassi ta' bisphosphonates, dystocia u terminazzjoni bikrija tal-istudju.
English: Aclasta was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Maltese: Aclasta kienet studjata f'pazjenti rġiel u nisa ta' etajiet ‘l fuq minn 30 sena li kellhom primarjament marda ta' Paget tal-għadam minn ħafifa sa moderata (il-medja tal-livell ta' alkaline phosphatase fisserum kienet 2.6-3.0 darbiet l-ogħla limitu tal-medda tar-referenza normali skont l-età fil-ħin li ddaħħlu għall-istudju) konfermata b'evidenza radjugrafika.
English: All cause mortality was 10% (101 patients) in the Aclasta-treated group compared to 13% (141 patients) in the placebo group.
Maltese: Il-mortalità mill-kawżi kollha kienet 10% (101 pazjent) fil-grupp li ngħata kura b'Aclasta meta mqabbel ma' 13% (141 pazjent) fil-grupp li ħa l-plaċebo.
English: In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with Aclasta and one patient treated with placebo.
Maltese: Fi prova klinika kbira, minn 7,736 pazjent, l-osteonekrożi tax-xedaq kienet irrappurtata f'pazjent wieħed ikkurat b'Aclasta u f'pazjent wieħed ikkurat bi plaċebo.
English: Aclasta is contraindicated during pregnancy (see section 4.3).
Maltese: Aclasta hu kontraindikat matul it-tqala (ara sezzjoni 4.3).
English: The chance of experiencing these side effects decreases with subsequent doses of Aclasta.
Maltese: Il-probabbilità li tħoss dawn l-effetti sekondarji tonqos bid-dożi ta' Aclasta sussegwenti.
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Maltese: Fl-ewwel 24 siegħa, 39 ± 16% tad-doża li tingħata tiġi rkuprata fl-awrina, filwaqt li jibqa' jkun fil-parti l-kbira mwaħħal mat-tessuti tal-għadam.
English: The study was planned to include 92 patients, however only 34 patients were enrolled and randomised to receive either a twice-yearly 0.05 mg/kg (max. 5 mg) intravenous zoledronic acid infusion or placebo for one year.
Maltese: L-istudju tħejja biex jinkludi 92 pazjent, madanakollu 34 pazjent biss issieħbu u kienu randomizzati biex jirċievu jew 0.05 mg/kg infużjoni ta' zoledronic acid fil-vina darbtejn fis-sena (massimu ta' 5 mg) jew plaċebo għal sena waħda.
English: Table 4 Between treatment comparisons of the incidence of key clinical fracture variables
Maltese: Tabella 4 Tqabbil bejn kura u oħra tal-varjabbli kliniċi tal-fratturi ewlenin
English: No interaction studies with other medicinal products have been performed with zoledronic acid.
Maltese: Ma saru l-ebda studji ta' interazzjoni ma' prodotti medċinali oħra b'zoledronic acid.
English: Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid.
Maltese: L-istoloġija tal-għadam kienet eżaminata f'7 pazjenti bil-marda ta' Paget 6 xhur wara kura b'5 mg zoledronic acid.
English: Children and adolescents Aclasta is not recommended for anyone under 18 years of age.
Maltese: Tfal u adolexxenti Aclasta mhux irrakkomandat għall-ebda persuna taħt it-18-il sena.
English: All patients were required to receive background therapy of vitamin D and calcium.
Maltese: Il-pazjenti kollha kellhom bżonn jirċievu terapija bażilari b'vitamina D u kalċju.
English: Non-vertebral fracture (1) *p-value <0.001, **p-value <0.0001 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Maltese: 0001 (1) Esklużi fratturi tas-swaba' tal-idejn, tas-saqajn jew fratturi tal-wiċċ (2) Inklużi fratturi kliniċi toraċiċi u l-irkiekel lumbari.
English: Absolute reduction in fracture incidence % (CI)
Maltese: Tnaqqis relattiv flinċidenza tal-fratturi % (CI)
English: Each bottle of 100 ml contains 5 mg zoledronic acid (as monohydrate).
Maltese: Kull flixkun b'100 ml ta' soluzzjoni fih 5 mg zoledronic acid (bħala monohydrate).
English: All participants received 1,000 mg elemental calcium plus 400 to 1,000 IU vitamin D supplementation per day.
Maltese: Il-parteċipanti kollha rċevew 1,000 mg kalċju bħala element flimkien ma' żieda ta' bejn 400 u 1000
English: Of the 153 Aclasta-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a mean duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%).
Maltese: Mill-153 pazjent ikkurati b'Aclasta u 115 pazjenti kkurati b'risedronate li ddaħħlu fl-istudju estiż ta' osservazzjoni, wara perjodu medju ta' 3.8 snin minn meta ngħataw id-dożaggi, il-proporzjon ta' pazjenti li temmu l-Perjodu Estiż ta' Osservazzjoni minħabba l-ħtieġa għal trattament mill-ġdid (ġudizzju kliniku) kien ogħla għal risedronate (48 pazjent, jew 41.7%) meta mqabbel ma' zoledronic acid (11-il pazjent, jew 7.2%).
English: The following should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Maltese: Dawn li ġejjin għandhom jiġu kkunsidrati fl-evalwazzjoni tar-riskju ta' pazjent li jiżviluppa ONJ: - Il-potenza tal-prodott mediċinali li jinibixxi risorbiment tal-għadam (riskju ogħla għal komposti potenti ħafna), ir-rotta tal-amministrazzjoni (riskju ogħla għal amministrazzjoni parenteli) u ddoża kumulattiva tat-terapija ta' risorbiment tal-għadam.
English: In another study in men (study CZOL446M2308) an annual infusion of Aclasta was non-inferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline.
Maltese: Fi studju ieħor fuq l-irġiel (studju CZOL446M2308), infużjoni darba f'sena ta' Aclasta ma kinetx inferjuri għal alendronate kull ġimgħa għall-bidla medja fil-BMD tal-ispina lumbari wara 24 xahar meta mqabbel mal-linja bażi.