FrancophonIA/ELRC3.0 huggingface dataset:
English: • A single dose of Zoledronic acid Teva Generics 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 m'għandhiex tkun ikbar minn 5 mg u t-tul tal-infużjoni għandu jkun ta' mill-inqas 15-il minuta (ara sezzjoni 4.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS (with blue box)
Maltese: KARTUNA TA' BARRA GĦALL-PAKKETTI MULTIPLI (bil-kaxxa blu)
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: Clinical vertebral fracture
Maltese: Fibrillazzjoni atrijali
English: Ocular hyperaemia
Maltese: Iperemija okulari
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' t½α 0.24 u t½β 1.87 sigħat, segwit b'fażi twila ta'
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
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 mill konċentrazzjoni.
English: In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
Maltese: Fir-riżultati magħqudin flimkien, tnaqqis simili fis-severità tal-uġigħ u fil-punteġġi ta' interferenza taluġigħ meta mqabbel mal-linja bażi kien osservat fuq 6 xhur għal zoledronic acid u risedronate.
English: What Zoledronic acid Teva Generics contains - The active substance is zoledronic acid.
Maltese: X'fiha Zoledronic acid Teva Generics - Is-sustanza attiva hi zoledronic acid.
English: It comes in a clear plastic bottle.
Maltese: Jiġi fi fliexkun tal-plastik ċar.
English: Microcomputed tomography (μCT) analysis demonstrated increased trabecular bone volume and preservation of trabecular bone architecture in patients treated with zoledronic acid 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'zoledronic acid meta mqabbla ma' plaċebo.
English: Severe and occasionally incapacitating bone, joint and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including zoledronic acid (see section 4.8).
Maltese: Uġigħ sever u kultant dgħufija fl-għadam, il-ġogi u/jew il-muskoli kien irrappurtat b'mod mhux frekwenti f'pazjenti fuq bisphosphonates, inkluż zoledronic acid (ara sezzjoni 4.8).
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: 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: In a large clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with zoledronic acid 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'zoledronic acid u f'pazjent wieħed ikkurat bi plaċebo.
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 talparatirojde, malassorbiment tal-kalċju mill-imsaren).
English: Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of drug with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Maltese: 30% sa 40% fl-indeboliment tal-kliewi ħafif għal moderat, imqabbel ma' pazjent b'funzjoni renali normali, u nuqqas ta' akkumulu tal-mediċina b'dożi multipli irrispettivament mill-funzjoni renali,
English: Clinical efficacy in the treatment of Paget's disease of the bone Zoledronic acid 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: Zoledronic acid 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 fis-serum 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: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Maltese: L-istabilità kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2 sa 8°C u 25ºC
English: Hypocalcaemia* Uncommon Anorexia, decreased appetite
Maltese: Mhux komuni Anoressija, tnaqqis fl-aptit
English: Each ml of solution contains 0.05 mg zoledronic acid (as monohydrate).
Maltese: Kull ml ta' soluzzjoni fih 0.05 mg zoledronic acid (bħala monohydrate).
English: Teva Pharma Belgium N.V.
Maltese: Nederland Teva Nederland B.V.
English: Therefore, interactions resulting from displacement of highly proteinbound drugs are unlikely.
Maltese: Għaldaqstant, nuqqas ta' qbil minħabba qlugħ ta' mediċini li jintrabtu ħafna mal proteini mhuwiex probabbli.
English: Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, anti-angiogenic medicinal products, radiotherapy, corticosteroids) and co-morbid conditions (e.g. anaemia, coagulopathies, infection, pre-existing dental disease).
Maltese: Għandu jkun ikkonsidrat li jkunu eżaminati s-snien u tingħata terapija preventiva xierqa qabel jibda ttrattament bil-bisphosphonates f'pazjenti li jkollhom fatturi ta' riskju konkomitanti (eż. kanċer, kimoterapija, prodotti mediċinali anti-anġjoġeniċi, kortikosterojdi, nuqqas ta' iġjene fil-ħalq).
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 mill-kawżi kollha kienet 10% (101 pazjent) fil-grupp li ngħata kura b'zoledronic acid meta mqabbel ma' 13% (141 pazjent) fil-grupp li ħa l-plaċebo.
English: You may eat normally on the day you are treated with Zoledronic acid Teva Generics.
Maltese: tiekol normali dakinhar meta qed tingħata t-trattament b'Zoledronic acid Teva Generics.
English: C-reactive protein increased Uncommon Blood calcium decreased
Maltese: Żieda fil-proteina reattiva C
English: It is supplied in multipacks containing 5 or 10 bags.
Maltese: Huwa jiġi f'pakketti multipli li fihom 5 jew 10 boroż.
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-ġenb totali u fl-għonq femorali meta mqabbel mal-kura bi plaċebo fil-punti kollha taż-żmien.
English: Teratogenicity was observed in rats at doses ≥ 0.2 mg/kg and was manifested by external, visceral and skeletal malformations.
Maltese: Teratoġeniċità dehret f'firien b'dożi ≥ 0.2 mg/kg u ħarġet bħala malformazzjonijiet esterni, vixxerali u skeletriċi.
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: Other products containing zoledronic acid as active substances are available for oncology indications.
Maltese: Huma disponibbli prodotti oħra li fihom zoledronic acid bħala sustanza attiva għal indikazzjonijiet tal-onkoloġija.
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 l esponiment 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: How to store Zoledronic acid Teva Generics
Maltese: Kif tingħata Zoledronic acid Teva Generics
English: Zoledronic acid Teva Generics 5 mg solution for infusion in bags zoledronic acid
Maltese: Zoledronic acid Teva Generics 5 mg soluzzjoni għall-infużjoni zoledronic acid
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 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 (ara sezzjoni 4.4).
English: For information on the infusion of Zoledronic acid Teva Generics, see section 6.6.
Maltese: Għal aktar tagħrif dwar l-infużjoni ta' Zoledronic acid Teva Generics, ara sezzjoni 6.6. 4.3 Kontraindikazzjonijiet
English: One bag contains 5 mg zoledronic acid (as monohydrate).
Maltese: Borża waħda fiha 5 mg zoledronic acid (bħala monohydrate).
English: Effect on morphometric vertebral fractures
Maltese: L-effett fuq fratturi morfometriċi tal-irkiekel
English: 6.5 Nature and contents of container multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Maltese: Borża b'ħafna saffi tal-polyolefin/styrene-ethylene-butylene (SEB) b'fetħa għall-infużjoni tal-SFC polypropylene magħluqa b'tapp tal-lastku u għatu li tneħħih b'sebgħek.
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: All participants received 1,000 mg elemental calcium plus 400 to 1,000 IU vitamin D supplementation per day.
Maltese: 1,000 mg kalċju bħala element flimkien ma' żieda ta' bejn 400 u 1000
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,
English: One bottle contains 5 mg zoledronic acid (as monohydrate).
Maltese: Kull borża fiha 5 mg zoledronic acid (bħala monohydrate).
English: INFORMATION FOR THE HEALTHCARE PROESSIONAL
Maltese: IL-PRODOTT MEDIĊINALI
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 mal inibizzjoni 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: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with zoledronic acid (see section 4.3).
Maltese: prodotti mediċinali oħra li jistgħu jkollhom impatt fuq il-funzjoni renali (ara sezzjoni 4.5).
English: Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis#
Maltese: Mhux komuni Dispepsja, uġigħ fin-naħa ta' fuq tal addome, uġigħ fl-addome, mard ta' rifluss gastroesofaġali, stitikezza, ħalq xott, esofaġite, uġigħ tas-snien, gastrite#
English: Uncommon Influenza, nasopharyngitis
Maltese: Ilma għall-injezzjonijiet
English: The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Maltese: Id-doża rrakkomandata hija ta' infużjoni waħda filvini ta' 5 mg zoledronic acid.
English: Pharmacokinetic/pharmacodynamic relationships
Maltese: Effetti farmakodinamiċi
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness Atypical subtrochanteric and diaphyseal fermoral fractures† (bisphosphonate class adverse reaction)
Maltese: 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, l għekiesi jew is-saqajn, għatx, uġigħ tas-snien, tibdil fis-sens tat-togħma.
English: Zoledronic acid Teva Generics 5 mg solution for infusion in bottles zoledronic acid
Maltese: Zoledronic acid Teva Generics 5 mg soluzzjoni għall-infużjoni fi fliexken Zoledronic acid
English: Effect on height
Maltese: Ksur atipiku tal-wirk
English: Not known** Scleritis and orbital inflammation
Maltese: Uveite, episklerite, irite Sklerite u infjammazzjoni orbitali
English: What Zoledronic acid Teva Generics is and what it is used for What you need to know before you are given Zoledronic acid Teva Generics How Zoledronic acid Teva Generics is given Possible side effects
Maltese: X'għandek tkun taf qabel ma tingħata Zoledronic acid Teva Generics Kif jingħata Zoledronic acid Teva Generics Effetti sekondarji possibbli
English: STATEMENT OF ACTIVE SUBSTANCE(S) One bag contains 5 mg zoledronic acid (as monohydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Borża waħda fiha 5 mg zoledronic acid (bħala monohydrate).
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 rriżultat f'żieda fil-BMD ta' 5.4% fil-ġenb totali u ta' 4.3% fl-għonq femorali fuq perjodu ta'
English: - The other ingredients are mannitol, sodium citrate and water for injections.
Maltese: Mannitol, sodium citrate u ilma għall-injezzjonijiet.
English: The highest non-lethal single intravenous dose was 10 mg/kg body weight in mice and 0.6 mg/kg in rats.
Maltese: L-ogħla doża minn ġol-vina li ma kkawżatx il-mewt kienet ta' 10 mg/kg skont il-piż tal-ġisem filġrieden u 0.6 mg/kg fil-firien.
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 fis-sistema riproduttiva inklużi malformazzjonijiet (ara sezzjoni 5.3). Ir-riskju potenzjali fuq in-nies mhuwiex magħruf.
English: • Reminder card with the following key messages: o Need to calculate creatinine clearance based on actual body weight using the CockcroftGault formula before each treatment with Zoledronic acid Teva Generics 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 Zoledronic acid Teva Generics 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 zoledronic acid administration o Need for appropriate physical activity, non-smoking and healthy diet
Maltese: Disfunzjoni renali kienet osservata wara li ngħata zoledronic acid, l-aktar f'pazjenti li kellhom disfunzjoni talkliewi minn qabel jew li kellhom xi fatturi ta' riskji oħrajn (eż. età avvanzata, pazjenti tal-onkoloġija fuq kimoterapija, l-użu konkomitanti ta' prodotti mediċinali nefrotossiċi fl-istess waqt, terapija djuretika konkomitanti, deidrazzjoni severa), li l-parti l-kbira tagħhom irċevew doża ta' 4 mg kull
English: In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to zoledronic acid administration (see section 4.2).
Maltese: Fil-prova għall-prevenzjoni tal-ksur kliniku wara ksur riċenti fil-ġenbejn, il-livelli tal-vitamina D ma ġewx imkejla b'mod regolari iżda l-maġġoranza tal-pazjenti rċevew loading dose ta' vitamina D qabel ma ngħataw zoledronic acid (ara sezzjoni 4.2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One bottle contains 5 mg zoledronic acid (as monohydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Flixkun wieħed fih 5 mg zoledronic acid (bħala monohydrate).
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: Frattura mhux tal-irkiekel (1) *valur-p <0.001, **valur-p <0.
English: Novartis Hrvatska d.o.o.
Maltese: Il-parteċipanti kollha rċevew
English: Nederland Teva Nederland B.V. Tel: +31 800 0228400
Maltese: Tel: +31 800 0228400
English: The use of Zoledronic acid Teva Generics in children and adolescents has not been studied.
Maltese: Zoledronic acid Teva Generics fi tfal u adolexxenti ma kienx studjat.
English: The use of Zoledronic acid Teva Generics in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Maltese: L-użu ta' Zoledronic acid Teva Generics f'pazjenti b'indeboliment renali sever (tneħħija tal-kreatinina < 35 ml/min) huwa kontraindikat minħabba riskju akbar ta' insuffiċjenza renali f'din il popolazzjoni.
English: Patients were stratified with respect to duration of glucocorticoid use prior to randomisation (≤ 3 months versus > 3 months).
Maltese: Il-pazjenti ġew imqassma fi gruppi skont it-tul ta' żmien ta' użu ta' glukokortikojdi qabel randomisation (≤ 3 xhur versus > 3 xhur).
English: Zoledronic acid Teva Generics may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Maltese: Zoledronic acid Teva Generics jista' wkoll jikkawża effetti sekondarji oħrajn Komuni ħafna (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10)
English: Zoledronic acid significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2).
Maltese: Zoledronic acid naqqas b'mod sinifikanti l-inċidenza ta' wieħed jew aktar fratturi ġodda fl-irkiekel fuq perjodu ta' tliet snin u dan sa mill-ewwel sena li ttieħdet bħala timepoint (ara Tabella 2).
English: Package leaflet: Information for the user
Maltese: • Pakkett ta' informazzjoni għall-pazjent
English: How Zoledronic acid Teva Generics is given
Maltese: Zoledronic acid Teva Generics tista'
English: Uncommonly, cases of osteonecrosis (primarily of the jaw) have been reported, predominantly in cancer patients treated with bisphosphonates, including zoledronic acid.
Maltese: Każijiet mhux komuni ta' osteonekrożi (l-aktar tax-xedaq) kienu rrappurtati, l-aktar f'pazjenti li jsofru minn kanċer ikkurati bil-bisphosphonates, inkluż zoledronic acid.
English: Before stopping Zoledronic acid Teva Generics therapy If you are considering stopping Zoledronic acid Teva Generics treatment, please go to your next appointment and discuss this with your doctor.
Maltese: Qabel twaqqaf it-terapija b'Zoledronic acid Teva Generics Jekk qed tikkonsidra li twaqqaf il-kura b'Zoledronic acid Teva Generics, jekk jogħġbok mur għall appuntament tiegħek li jmiss u ddiskuti dan mat-tabib tiegħek.
English: Table 3 Between treatment comparisons of the incidence of key clinical fracture variables over 3 years
Maltese: Tabella 3 Tqabbil bejn il-kuri tal-inċidenza ta' varjanti kliniċi ewlenin fuq 3 snin
English: Zoledronic acid Teva Generics 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: BATCH NUMBER
Maltese: U KWANTITATTIVA
English: Longer-term repeat administration at cumulative exposures sufficiently exceeding the maximum intended human exposure produced toxicological effects in other organs, including the gastrointestinal tract and liver, and at the site of intravenous administration.
Maltese: Meta ngħataw dożi ripetuti għal tul ta' żmien li laħqu esponimenti kumulattivi li qabżu biżżejjed logħla esponiment intiż għall-bniedem wasslu għal effetti tossikoloġiċi f'organi oħrajn, inklużi lpassaġġ gastrointestinali u l-fwied, u fil-post mnejn tingħata l-infużjoni ġol-vina.
English: It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Generics, as directed by your healthcare provider.
Maltese: Importanti li tixrob mill-inqas 2 tazzi fluwidu (bħal ilma), fi żmien ftit sigħat qabel ma tieħu Zoledronic acid Teva Generics, kif indikat minn min qed jiddireġik.
English: - After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Maltese: - Wara l-ftuħ tal-borża, l-istabilità kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2 sa 8ºC u 25ºC.