FrancophonIA/ELRC3.0 huggingface dataset:
English: Bone specific alkaline phosphatase (BSAP), serum N-terminal propeptide of type I collagen (P1NP) and serum beta-C-telopeptides (b-CTx) were evaluated in subsets ranging from 517 to 1,246 patients at periodic intervals throughout the study.
Maltese: Alkaline phosphatase speċifiku għall-għadam (BSAP), propeptajd N-terminali fis-serum tal-kollaġen tat-tip I (P1NP) u beta-C-telopeptajds (b-CTx) fis-serum kienu evalwati fis-sottosettijiet li kienu jvarjaw minn 517 sa 1,246 pazjent f'intervalli perjodiċi matul l-istudju.
English: Concomitant osteoporosis therapy included: calcitonin, raloxifene, tamoxifen, hormone replacement therapy, tibolone; but excluded other bisphosphonates.
Maltese: Terapija għall-osteoporożi fl-istess ħin kienet tinkludi: calcitonin, raloxifene, tamoxifen, terapija tal-hormone replacement, tibolone; iżda kienet teskludi bisphosphonates oħrajn.
English: Frequency categories are defined using the following convention: 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); not known
Maltese: Kategoriji tal-frekwenza huma ddefiniti bl-użu tal-konvenzjoni li jmiss: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari
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 tal-Ksur [PFT] (ara sezzjoni 5.1), l-inċidenza globali talfibrillazzjoni atrijali kienet 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: EXP After opening: 24 hours at 2°C - 8°C
Maltese: Wara li jinfetaħ: 24 siegħa f'2°C - 8°C.
English: - Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
Maltese: − Indeboliment renali sever bi tneħħija tal-kreatinina < 35 ml/min (ara sezzjoni 4.4).
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 jiġu biss bħala pakketti multipli li fihom 5 jew 10 pakketti, kull wieħed fih flixkun wieħed.
English: - Patients with hypocalcaemia (see section 4.4).
Maltese: − Pazjenti f'ipokalċimija (ara sezzjoni 4.4).
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: 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: Frattura mhux tal-irkiekel (1) *valur-p <0.05, **valur-p <0.01 (1) Esklużi fratturi fis-swaba' tal-idejn, saqajn u fratturi fil-wiċċ
English: Zoledronic acid is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Maltese: Zoledronic acid huwa kontraindikat f'pazjenti bi tneħħija tal-kreatinina < 35 ml/min (ara sezzjonijiet 4.3 u 4.4).
English: Táncsics Mihály út 82.,
Maltese: TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82.,
English: Effect on bone mineral density (BMD)
Maltese: Effett fuq id-densità minerali tal-għadam (BMD)
English: (≥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); not known (cannot be estimated from the available data).
Maltese: (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli.
English: The zoledronic acid group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
Maltese: Il-grupp fuq zoledronic acid wera madwar 2.5 mm anqas telf fit-tul meta mqabbel malplaċebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
English: Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Maltese: Influwenza, infezzjonijiet fin-naħa ta' fuq tal-apparat tan-nifs, tnaqqis fl-għadd taċ-ċelluli ħomor, telf ta' aptit, nuqqas ta' rqad, xejra ta' ngħas li tista' tinkludi li tkun anqas ilvent u konxju ta' x'qed jiġri, sensazzjoni ta' tnemnim jew titrix, għeja estrema, tregħid, tintilef minn sensik temporanjament, infezzjoni jew irritazzjoni jew infjammazzjoni fl-għajn bl-uġigħ u l-ħmura, tħoss kollox idur bik, żieda fil-pressjoni fid-demm, fwawar, sogħla, qtugħ ta' nifs, stonku mqalleb, uġigħ fl-addome, stitikezza, ħalq xott, ħruq ta' stonku, raxx fil-ġilda, għaraq żejjed, ħakk, ħmura fil-ġilda, uġigħ fl-għonq, ebusija fil-muskoli, fl-għadam u/jew fil-ġogi, nefħa fil-ġogi, spażmi fil-muskoli, uġigħ fl-ispalla, uġigħ fil muskoli ta' sidrek jew fil-qafas ta' sidrek, infjammazzjoni fil-ġogi, dgħjufija fil-muskoli, riżultati tat testijiet tal-kliewi mhux normali, tgħaddi l-awrina b'mod frekwenti mhux normali, nefħa tal-idejn, lgħekiesi jew is-saqajn, għatx, uġigħ tas-snien, tibdil fis-sens tat-togħma.
English: Uncommon Lethargy, paraesthesia, somnolence, tremor, syncope, dysgeusia
Maltese: Mhux komuni Tħeddil, parasteżija, ngħas, tregħid, sinkope, disgewżja
English: Tabulated list of adverse reactions Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi f'Tabella 1 huma mniżżla skont is-sistema MedDRA ta' klassifikazzjoni talorgani u tal-kategorija ta' frekwenza.
English: The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy.
Maltese: It tnaqqis fir-riskju kien ta' 51% fil-pazjenti li ma ħadux bisphosphone u 42% fil-pazjenti li tħallew jieħdu terapija konkomitanti għall-osteoporożi.
English: Observed in patients taking concomitant glucocorticosteroids.
Maltese: Osservata f'pazjenti li jieħdu glukokortikosterojdi konkomitanti.
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 żied 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: 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: Rikorrenti [RFT]) l-inċidenza tal-każijiet ta' fibrillazzjoni fl-atrija miġbura flimkien kienu jaqblu bejn zoledronic acid (2.6%) u l-plaċebo (2.1%).
English: Zoledronic acid Teva Generics contains the active substance zoledronic acid.
Maltese: Zoledronic acid Teva Generics fih is-sustanza attiva zoeldronic acid.
English: Zoledronic acid is eliminated by renal excretion.
Maltese: Zoledronic acid jiġi eliminat permezz tal-eskrezzjoni renali.
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 ngħata 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: 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 tal-vitamina D ma ġewx imkejla b'mod regolari iżda ngħatat loading dose ta' vitamina D (50,000 sa 125,000
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-krejatinina fis-serum) u f'każijiet rari indeboliment renali akuta.
English: Zoledronic acid Teva Generics is supplied in packs of 1, 5 or 10 bottles.
Maltese: Zoledronic acid Teva Generics jiġi f'pakketti ta' 1, 5 jew 10 fliexken.
English: Headache, dizziness
Maltese: Mhux komuni Influwenza, nażofarinġite
English: Limited data on re-treatment of Paget's disease are available (see section 5.1).
Maltese: Teżisti informazzjoni limitata dwar trattament mill ġdid tal-marda ta' Paget (ara sezzjoni 5.1).
English: Placebo (N = 1,062) event rate
Maltese: (N=1,062) rata tal-każ
English: Κύπρος Teva Ελλάς Α.Ε.
Maltese: Κύπρος Teva
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 wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000
Maltese: Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
English: Histomorphometric analysis showed a 63% reduction in bone turnover.
Maltese: Analiżi istomorfometrika wriet tnaqqis ta' 63% fit-tibdil tal-għadam.
English: Uncommon Blood creatinine increased, pollakiuria, proteinuria
Maltese: Mhux komuni Żieda fil-kreatinina tad-demm, pollakijurja, proteinurja
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 jiem 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 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 mal proteini mhuwiex probabbli.
English: Uveitis, episcleritis, iritis
Maltese: Dardir, rimettar, dijarea
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 bħala element flimkien ma' 800 sa 1,200 IU ta' suppliment ta' vitamina D kuljum.
English: - Pregnancy and breast-feeding (see section 4.6).
Maltese: − Tqala u t-treddigħ (ara sezzjoni 4.6).
English: The efficacy of one infusion of 5 mg zoledronic acid versus daily doses of 30 mg risedronate for 2 months was demonstrated in two 6-month comparative trials.
Maltese: L-effikaċja ta' infużjoni waħda ta' 5 mg zoledronic acid kontra d-dożi kuljum ta' 30 mg risedronate għal xahrejn intweriet f'żewġ provi komparattivi li damu 6 xhur.
English: Summary of vertebral fracture efficacy at 12, 24 and 36 months
Maltese: Tabella 2 Sommarju tal-effikaċja fuq il-fratturi tal-irkiekel mat-12, 24 u 36 xahar
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Madankollu, id-detentur talawtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali jekk il-prodott huwa inkluż fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
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, double-blind, 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: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Generics for the treatment of postmenopausal osteoporosis.
Maltese: Ritmu tal-qalb irregolari (fibrillazzjoni atrijali) dehret f'pazjenti mogħtija Zoledronic acid Teva Generics għat-trattament ta' osteoporożi postmenopawżali.
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: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Mediċini http://www.ema.europa.eu
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Maltese: Mediċini għall-kura tal-mard tal-għadam, bisphosphonates, Kodiċi ATC:
English: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Maltese: Għall-każijiet serji ta' fibrillazzjoni fl-atrija miġbura flimkien il-każijiet kienu 1.3% għal zoledronic acid u 0.8% għal plaċebo.
English: All women received 1,000 to 1,500 mg elemental calcium and 400 to 1,200 IU of vitamin D supplements daily.
Maltese: In-nisa kollha rċevew minn 1,000 sa 1,500 mg kalċju bħala element u 400 sa 1,200 IU ta' vitamina D bħala suppliment kuljum.
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: Absolute reduction in fracture incidence % (CI)
Maltese: frattura % (CI)
English: Malta Drugsales Ltd
Maltese: Il-Pajjiżi l-Baxxi
English: 2031 GA Haarlem The Netherlands
Maltese: 2031GA Haarlem
English: Relative risk reduction in fracture incidence % (CI)
Maltese: Tnaqqis relattiv tar riskju fl-inċidenza tal-frattura % (CI)
English: Special populations (see section 4.2)
Maltese: Prodott, sezzjoni 4.2).
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Maltese: Ahżen f'temperatura taħt 30°C.
English: In the intravenous bolus studies, the doses that were welltolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks.
Maltese: Fi studji ta' bolus mogħti ġol-vina, id-dożi li kienu ttollerati sew naqsu aktar ma twal l-istudju: 0.2 u 0.02 mg/kg kuljum kienu ttollerati sew għal 4 ġimgħat f'firien u klieb, rispettivament iżda 0.01 mg/kg u 0.005 mg/kg biss f'firien u klieb, rispettivament, meta jingħata għal 52 ġimgħa.
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Maltese: Zoledronic acid ġie evalwat fil-ġrieden għal effetti avversi potenzjali fuq il-fertilità tal-ġenerazzjoni tal-ġenituri u dik F1.
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 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 tal-għonq 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 inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively.
Maltese: Il-varjazzjoni bejn l-individwi u fl-individwu u għat-tneħħija ta' zoledronic acid mill-plażma ntwera li kienet 36% u 34% rispettivament.
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 tal kalċju fis-serum (anqas minn 1.87 mmol/l) wara li ngħataw zoledronic acid.
English: Zoledronic acid Teva Generics is supplied in multipacks containing 5 or 10 bags.
Maltese: Zoledronic acid Teva Generics jiġi f'pakketti multipli li fihom 5 jew 10 boroż.
English: Intravenous use.
Maltese: Teva Generics.
English: It comes in a polyolefin/styrene-ethylene-butylene (SEB) foil bag with a foil over pouch.
Maltese: Jiġi f'borża ta' fojl tal-polyolefin/styrene-ethylene-butylene (SEB) b'borża fuq barra tal-fojl.
English: In patients with a recent low-trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first zoledronic acid infusion.
Maltese: F'pazjenti bi ksur tal-ġenbejn bi trawma baxxa reċenti, doża ta' tagħbija 50 000 sa 125 0000 IU tal vitamina D mogħtija oralment jew permezz tar-rotta intramuskolari, hija rrakkomandata qabel l-ewwel infużjoni ta' zoledronic acid.
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 medication.
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-medikazzjoni tal-istudju.
English: België/Belgique/Belgien Teva Pharma Belgium N.V. Tel/Tél: +32 3 820 73 73
Maltese: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tel/Tél:
English: In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
Maltese: Fl-istudju HORIZON-RFT, 508 irġiel ġew randomised fl-istudju u 185 pazjent kellhom il-BMD
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Maltese: Ksur subtrokanteriku u diaphyseal atipiku tal-wirk (reazzjoni avversa tal-klassi tal-bisphosphonates).
English: Zoledronic acid (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate.
Maltese: Zoledronic acid (5 mg f'100 ml soluzzjoni lesta biex tintuża) tingħata minn pajp tal-infuzjoni ventat u b'rata tal-infużjoni fissa.
English: It is prudent to avoid dental surgery as recovery may be prolonged (see section 4.4).
Maltese: Ikun għaqli li kirurġiji dentali jiġu evitati minħabba li l konvalexxenza tista' tittawwal (ara sezzjoni 4.4).
English: LIST OF EXCIPIENTS Excipients: Mannitol, sodium citrate and water for injections.
Maltese: Eċċipjenti: Mannitol, sodium citrate u ilma għall-injezzjonijiet.
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 hip fracture event rate was 1.44% for zoledronic acid-treated 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 mill kliewi 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: 1 bag of 100 ml
Maltese: Flixkun 1 ta'100 ml
English: Each bag contains 100 ml of solution.
Maltese: Kull borża fiha 100 ml ta' soluzzjoni.
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Generics.
Maltese: Il-probabbilità li tħoss dawn l-effetti sekondarji tonqos bid-dożi ta' Zoledronic acid Teva Generics sussegwenti.
English: Zoledronic acid is contraindicated during pregnancy (see section 4.3).
Maltese: Zoledronic acid hu kontraindikat matul it-treddigħ (ara sezzjoni 4.3).
English: - Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Maltese: - L-istabilità kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2 sa 8ºC u 25ºC.