FrancophonIA/ELRC3.0 huggingface dataset:
English: Zoledronic acid Teva Pharma is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Maltese: Zoledronic acid Teva Pharma huwa kontraindikat f'pazjenti bi tneħħija tal-kreatinina < 35 ml/min (ara sezzjonijiet 4.3 u 4.4).
English: Zoledronic acid significantly increased BMD at the lumbar spine, hip, and distal radius relative to treatment with placebo at all timepoints (6, 12, 24 and 36 months).
Maltese: Zoledronic acid żiedet b'mod sinifikanti l-BMD fis-sinsla lumbari, fil-ġenbejn u fid-distal radius meta mqabbel mal-kura bil-plaċebo fit-timepoints kollha (6, 12, 24 u 36 xhur).
English: The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy.
Maltese: Ittnaqqis fir-riskju kien ta' 51% fil-pazjenti li ma ħadux bisphosphone u 42% fil-pazjenti li tħallew jieħdu terapija konkomitanti għall-osteoporożi.
English: The incidence of fractures was 8 for zoledronic acid-treated patients versus 7 for risedronate-treated patients (p=0.8055).
Maltese: L-inċidenza ta' ksur kienet 8 għal pazjenti kkurati b'Zoledronic acid versus 7 għal pazjenti kkurati b'risedronate-(p=0.8055).
English: Zoledronic acid Teva Pharma contains the active substance zoledronic acid.
Maltese: Zoledronic acid Teva Pharma fiha s-sustanza attiva zoeldronic acid.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Maltese: Zoledronic acid mogħti ġol-vina jiġi eliminat minn proċess ta' tliet fażijiet: l-għajbien mgħaġġel miċċirkolazzjoni sistemika f'żewġ fażijiet, b'half-lives ta' t½ 0.24 u t½ 1.87 sigħat, segwit b'fażi twila ta' eliminazzjoni b'half-life terminali ta' eliminazzjoni ta' t½ 146 siegħa.
English: In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between zoledronic acid (2.6%) and placebo (2.1%).
Maltese: Fil-provi dwar l-osteoporożi (PFT, HORIZON - Prova dwar Ksur Rikorrenti [RFT - Recurrent Fracture Trial]) l-inċidenza tal-każijiet ta' fibrillazzjoni tal-atriju miġbura flimkien kienu jaqblu bejn zoledronic acid (2.6%) u l-plaċebo (2.1%).
English: All participants received 1,000 to 1,500 mg of elemental calcium plus 800 to 1,200 IU of vitamin D supplementation per day.
Maltese: Il-parteċipanti kollha rċevew 1,000 sa 1,500 mg ta' kalċju elementali flimkien ma' 800 sa 1,200 IU ta' suppliment ta' vitamina D kuljum.
English: Solution for infusion Multipack: 5 bags of 100 ml Multipack: 10 bags of 100 ml
Maltese: Soluzzjoni għall-infużjoni Pakkett b'ħafna: 5 fliexken ta' 100 ml Pakkett b'ħafna: 10 fliexken ta' 100 ml
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
Maltese: Fl-istudju HORIZON - Prova Pivitali dwar il-Ksur [PFT - Pivotal Fracture Trial] (ara sezzjoni 5.1), l-inċidenza globali ta' fibrillazzjoni tal-atriju kienet ta' 2.5% (96 minn 3,862) u 1.9% (75 minn 3,852) f'pazjenti li kienu qed jirċievu zoledronic acid u plaċebo, rispettivament.
English: Cockcroft-Gault formula before each Zoledronic acid Teva Pharma dose.
Maltese: Cockcroft-Gault qabel kull doża ta' Zoledronic acid Teva Pharma.
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound drugs are therefore unlikely.
Maltese: Zoledronic acid ma jingħaqadx bil-qawwa mal-proteini tal-plażma (madwar 43-55% jingħaqad) u għaldaqstant nuqqas ta' qbil li jirriżulta minn qlugħ ta' mediċini li jkunu marbutin malproteini mhuwiex probabbli.
English: All cause mortality was 10% (101 patients) in the zoledronic acid-treated group compared to 13% (141 patients) in the placebo group.
Maltese: Il-mortalità minn kwalunkwe kawża kienet 10 % (101 pazjent)fil-grupp ikkurat b'zoledronic acidmeta mqabbel ma' 13 % (141 pazjent) fil-grupp ta' plaċebo.
English: Renal impairment has been observed following the administration of zoledronic acid (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 zoledronic acid administration.
Maltese: Ġie osservat indeboliment renali wara li ngħatat Zoledronic acid (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' Zoledronic acid.
English: Table 2 Summary of vertebral fracture efficacy at 12, 24 and 36 months Outcome
Maltese: Tabella 2 Sommarju tal-effikaċja fuq il-fratturi tal-irkiekel mat-12, 24 u 36 xahar
English: The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Maltese: Id-daqsijiet tal-pakkett ta' 5 u 10 fliexken jinbiegħu biss f'pakketti multipli li jkun fihom 5 jew 10 pakketti, kull wieħed ikun fih flixkun 1.
English: - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Maltese: - It-terapiji konkomitanti: kortikosterojdi, kimoterapija, inibituri tal-anġjoġenesi, radjuterapija
English: • Physician educational material
Maltese: • Materjal edukattiv għall-pazjent
English: 2031 GA Haarlem The Netherland
Maltese: 2031 GA Haarlem L-Olanda
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (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 tal-atriju żdiedet f'pazjenti li kienu qed jirċievu zoledronic acid (1.3%) (51 minn 3,862) meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo (0.6%) (22 minn 3,852).
English: Zoledronic acid has been associated with renal impairment manifested as deterioration in renal function (i.e. increased serum creatinine) and in rare cases acute renal failure.
Maltese: Zoledronic acid kien assoċjat ma' indeboliment renali li kienet manifestata bħala tħażżin fil-funzjoni renali (jiġifieri żieda tal-kreatinina fis-serum) u f'każijiet rari indeboliment renali akuta.
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Pharma for the treatment of postmenopausal osteoporosis.
Maltese: Ritmu tal-qalb irregolari (fibrillazzjoni atrijali) deher f'pazjenti mogħtija Zoledronic acid Teva Pharma għat-trattament ta' osteoporożi postmenopawżali.
English: oesophagitis, toothache, gastritis#
Maltese: Uġigħ ta' ras, sturdament
English: Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Maltese: Peress li zoledronic acid ma jiġix immetabolizzat mill-bnedmin u s-sustanza nstabet li kellha ftit jew l-ebda ħila bħala impeditur tal-enzimi P450 li jaħdem b'mod dirett u/jew b'mod irriversibbli dipendenti fuq ilmetaboliżmu, mhux probabbli li zoledronic acid jnaqqas it-tneħħija ta' sustanzi li jiġu mmetabolizzati permezz tas-sistemi ta' enzimi ta' cytochrome P450.
English: Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Maltese: Ksur mhux vertebrali (1) *valur-p <0.05, **valur-p<0.01 (1) Eskluż ksur tal-wiċċ, tas-swaba' tal-idejn u tas-swaba' tas-saqajn (2)
English: Cyclic olefin polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc.
Maltese: Flixkun tal-plastik tat-tip polimeru ċikliku olefiniku (COP), it-tnejn b'tapp tal-gomma klorobutil/butil u għatu tal-aluminju b'tagħmir tal-plastik ta' lew vjola biex tkun tista' tiftħu b'subgħajk.
English: Clinical efficacy in osteoporosis associated with long-term systemic glucocorticoid therapy The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, doubleblind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent).
Maltese: L-effikaċja u s-sigurtà ta' Zoledronic acid fil-kura u l-prevenzjoni tal-osteoporożi assoċjata mal-kura sistemika bi glukokortikojdi għal perjodu twil ta' żmien kienu stmati fi studju randomised, multiċentriku, double-blind, stratifikat, u kkontrollat b'mod attiv ta' 833 raġel u mara li għandhom bejn it-18 u l-85 sena (età medja għall-irġiel 56.4 snin; għan-nisa 53.5 snin) ikkurati b' > 7.5 mg/kuljum ta' prednisone mill-ħalq (jew ekwivalenti).
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 zoledronic acid 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 Zoledronic acid.
English: - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
Maltese: - qed tieħu mediċini msejħa kortikosterojdi (bħal prednisolone jew dexamethasone) - għandek kanċer.
English: • A single dose of Zoledronic acid Teva Pharma should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
Maltese: • Doża singola ta' Zoledronic acid Teva Pharma m'għandhiex tkun ikbar minn 5 mg u t-tul talinfużjoni għandu jkun ta' mill-inqas 15-il minuta (ara sezzjoni 4.2).
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 zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-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'Zoledronic acid fi prova klinika kbira meta mqabbla ma' 21% tal-pazjenti kkurati b'Zoledronic acid fil-provi bil-marda ta' Paget.
English: Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT) The efficacy and safety of zoledronic acid 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s).
Maltese: L-effikaċja klinika tal-kura tal-osteoporożi ta' wara l-menopawża (PFT) L-effikaċja u s-sigurtà ta' Zoledronic acid 5 mg darba fis-sena għal tliet snin konsekuttivi ntwerew f'nisa ta' wara l-menopawża (7,736 mara ta' etajiet bejn 65-89 sena) b'densità minerali tal-għadam talgħonq femorali (BMD) bil-punteġġ-T ≤ -1.5 u almenu żewġ fratturi fl-irkiekel ħfief jew jekk ikun hemm frattura(i) tal-irkiekel waħda moderata; jew inkella BMD tal-għonq femorali bil-punteġġ-T ≤2.5 b'evidenza ta' frattura(i) fl-irkiekel jew mingħajrha. 85% tal-pazjenti qatt ma kienu ħadu kura b'bisphosphonate.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan ilprodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Treatment with zoledronic acid resulted in a 6.7% increase in BMD at the lumbar spine, 6.0% at the total hip, 5.1% at the femoral neck, and 3.2% at the distal radius over 3 years as compared to placebo.
Maltese: Il-kura b'zoledronic acid wasslet għal żieda ta' 6.7% fil-BMD fis-sinsla lumbari, 6.0% tal-ġenb totali, 5.1% fl-għonq femorali, u 3.2% fid-distal radius fuq 3 snin meta mqabbla mal-plaċebo.
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 zoledronic acid versus 8.7% for placebo.
Maltese: L-istudju ma kienx potenzjat biex juri tnaqqis fil-fratturi kliniċi fl-irġiel; l-inċidenza ta' fratturi kliniċi f'irġiel ikkurati b'Zoledronic acid kienet 7.5% kontra 8.7% għall-plaċebo.
English: Zoledronic acid significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01).
Maltese: Zoledronic acid naqqas b'mod sinifikanti l-medja tal-jiem ta' attività limitata u l-jiem ta' serħan ġossodda minħabba uġigħ tad-dahar b'17.9 jiem u 11.3 ijiem rispettivament meta mqabbla mal-plaċebo u naqqas b'mod sinifikanti l-medja ta' ġranet ta' attività limitata u l-ġranet ta' serħan ġos-sodda minħabba fratturi b'2.9 jiem u 0.5 jiem rispettivament meta mqabbla mal-plaċebo (kollha p<0.01).
English: Zoledronic acid Teva Pharma is contraindicated during pregnancy (see section 4.3).
Maltese: Zoledronic acid Teva Pharma hu kontraindikat matul it-tqala (ara sezzjoni 4.3).
English: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Maltese: Għall-każijiet avversi serji ta' fibrillazzjoni tal-atriju l-inċidenza tal-każijiet miġbura flimkien kienet ta' 1.3% għal zoledronic acid u 0.8% għal plaċebo.
English: What Zoledronic acid Teva Pharma contains - The active substance is zoledronic acid.
Maltese: X'fih Zoledronic acid Teva Pharma - Is-sustanza attiva hi zoledronic acid.
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 zoledronic acid (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'Zoledronic acid (N=82) jew plaċebo (N=70).
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Pharma.
Maltese: Il-probabbilità li tħoss dawn l-effetti sekondarji tonqos bid-dożi ta' Zoledronic acid Teva Pharma sussegwenti.
English: The hip fracture event rate was 1.44% for zoledronic acidtreated patients compared to 2.49% for placebo-treated patients.
Maltese: Ir-rata tal-każijiet tal-frattura tal-ġenbejn kienet 1.44% għall-pazjenti kkurati b'Zoledronic acid meta mqabbla ma' 2.49% għall-pazjenti kkurati bi plaċebo.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Maltese: It-tneħħija renali ta' zoledronic acid kienet relatata mat-tneħħija tal-kreatinina, fejn it-tneħħija millkliewi kienet tirrappreżenta 75  33% tat-tneħħija tal-kreatinina, li wriet medja ta' 84  29 ml/min (medda minn 22 sa 143 ml/min) fl-64 pazjent li kien studjat.
English: • in adult men at increased risk of fracture.
Maltese: • f'irġiel adulti li jkollhom riskju akbar ta' ksur.
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, 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 fl-ispallejn, uġigħ muskoluskeletriku fis-sider, uġigħ muskoluskeletriku, ebusija fil-ġogi, artrite, dgħjufija tal-muskoli
English: For information on the infusion of Zoledronic acid Teva Pharma, see section 6.6.
Maltese: Għal aktar tagħrif dwar l-infużjoni ta' Zoledronic acid Teva Pharma, ara sezzjoni 6.6.
English: Zoledronic acid Teva Pharma is contraindicated during breast-feeding (see section 4.3).
Maltese: Zoledronic acid Teva Pharma hu kontraindikat matul it-treddigħ (ara sezzjoni 4.3).
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 wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: EXP After opening: 24 hours at 2°C - 8°C
Maltese: JIS Wara li jinfetaħ: 24 siegħa f'2°C - 8°C
English: In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001).
Maltese: Fis-sottopopolazzjoni ta' pazjenti li rċevew glukokortikojdi għal aktar minn 3 xhur qabel randomisation, Zoledronic acid żied il-BMD tas-sinsla lumbari b'4.06% versus 2.71% għal risedronate (differenza medja: 1.36%; p<0.001).
English: Multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Maltese: Borża b'bosta kisjiet magħmulin minn polyolefin/styrene-ethylene-butylene (SEB) b'tapp tal-gomma SFC polypropylene bit-toqba għall-infużjoni magħluqa u b'għatu li jinfetaħ b'subgħajk.
English: Zoledronic Placebo Absolute reduction Relative risk acid (N=3,875) event rate
Maltese: Rata ta' avveniment i b'Zoledroni c acid (N=1,065)
English: There was a transient increase in serum creatinine observed within 10 days in 1.8% of zoledronic acid-treated patients versus 0.8% of placebo-treated patients.
Maltese: Kien hemm żieda momentanja tal-kreatinina fis-serum fi żmien 10 ijiem f'1.8% tal-pazjenti kkurati b'Zoledronic acid kontra 0.8% tal-pazjenti kkurati bi plaċebo.
English: In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid 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 kienu rċevew glukokortikojdi għal 3 xhur jew inqas qabel randomisation, Zoledronic acid żied il-BMD tas-sinsla lumbari b'2.60% versus 0.64% għal risedronate (differenza medja: 1.96%; p<0.001).
English: Teva Ελλάς Α.Ε.
Maltese: Mekkaniżmu ta' azzjoni
English: Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Maltese: (reazzjoni avversa għall-klassi bifosfonati) Osteonekrożi tax-xedaq (ara l-effetti skont il-klassi f'sezzjonijiet 4.4 u 4.8)
English: Sodium citrate Water for injections
Maltese: Sodium citrate
English: Special populations Patients with renal impairment
Maltese: Popolazzjonijiet speċjali Pazjenti b'indeboliment renali
English: EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles EU/1/12/772/005 1 bottle
Maltese: EU/1/12/772/001 pakkett b'ħafna b'5 fliexken EU/1/12/772/002 pakkett b'ħafna b'10 fliexken EU/1/12/772/005 flixkun wieħed
English: Zoledronic acid-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'Zoledronic acid 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: Osteonecrosis of the external auditory canal† (bisphosphonate class adverse reaction)
Maltese: (reazzjoni avversa tal-klassi tal-bisphosphonate) Osteonekrożi tal-kanal estern tas-smigħ†
English: In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.4).
Maltese: F'pazjenti bil-marda ta' Paget, huwa rrakkomandat ħafna li jiġi żgurat kalċju supplimentali adegwat li jikkorrespondi għal mill-inqas 500 mg kalċju elementali darbtejn kuljum għal mill-inqas 10 ijiem wara l-għoti ta' Zoledronic acid Teva Pharma (ara sezzjoni 4.4).
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 malproteini tal-plażma (madwar 43-55% jintrabat) u l-irbit huwa indipendenti mill-konċentrazzjoni.
English: Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion.
Maltese: Il-livelli ta' vitamina D ma tkejlux b'mod regolari iżda d-doża ta' manteniment ta' vitamina D (50,000 sa 125,000
English: Relative reduction in fracture incidence % (CI)
Maltese: Tnaqqis relattiv tarriskju fl-inċidenza tal-frattura % (CI)
English: At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in postmenopausal 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'Zoledronic acid, meta mqabbel mal-effetti osservati f'nisa ta' wara l-menopawża fl-istudju HORIZON-PFT.
English: In the HORIZON-RFT study zoledronic acid treatment significantly increased BMD at the total hip and femoral neck relative to treatment with placebo at all timepoints.
Maltese: Fl-istudju HORIZON-RFT, il-kura b'zoledronic acid żiedet b'mod sinifikanti l-BMD fil-ġenbejn totali u l-għonq femorali relattivament għall-kura bi plaċebo fil-punti ta' żmien kollha.
English: Relative risk reduction in fracture incidence % (CI)
Maltese: Tnaqqis fir-riskju relattiv fl-inċidenza ta' ksur % (CI)
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 tal-BMD tal-għonq femorali taħt -2.5 u madwar 45 % tal-pazjenti kellhom punteġġ-T tal-BMD tal-għonq femorali 'l fuq minn 2.5. Zoledronic acid ingħata darba fis-sena, sakemm tal-inqas 211-il pazjent fil-popolazzjoni tal-istudju kienu kkonfermati bi ksur kliniku.
English: Zoledronic acid Teva Pharma contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull 100 ml, jiġifieri essenzjalment “ħieles mis-sodium”.
English: EU/1/12/772/004 multipack with 10 bags
Maltese: EU/1/12/772/004 pakkett b'ħafna b'10 boroż
English: Treatment with zoledronic acid 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'zoledronic acid irriżultat f'żieda fil-BMD ta' 5.4 % fil-ġenbejn totali u 4.3 % fl-għonq femorali matul 24 xahar meta mqabbel ma' plaċebo.