FrancophonIA/ELRC3.0 huggingface dataset:
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Maltese: L-iżbilanċ osservat f'din il-prova ma ġiex osservat fi provi oħrajn b'zoledronic acid, inklużi dawk b'4 mg ta' zoledronic acid (zoledronic acid) kull 3-4 ġimgħat f'pazjenti tal-onkoloġija.
English: The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Maltese: L-effetti avversi li ġejjin, elenkati f'Tabella 2 inġabru f'daqqa mill-istudji kliniċi u minn rapporti ta' wara t-tqegħid fis-suq wara kura li fil-parti l-kbira kienet kronika b'zoledronic acid 4 mg:
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-firien għall-possibbiltà ta' effetti mhux mixtieqa fuq il-fertilità tal-ġenerazzjoni parentali u ta' F1.
English: 4 mg
Maltese: MM MM 424
English: Zoledronic Acid Hospira contains sodium
Maltese: Zoledronic Acid Hospira fih is-sodju
English: − Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Maltese: - Indeboliment sever tal-kliewi (li normalment jiġi stabbilit mit-tabib tiegħek permezz ta' ċerti testijiet speċifiċi tad-demm).
English: The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Maltese: Id-doża rrakkomandata għall-kura ta' żieda fil-livell ta' kalċju fid-demm (livell ta' kalċju fis-serum korrett għall-albumina 12.0 mg/dl jew 3.0 mmol/l) hija doża waħda ta' 4 mg zoledronic acid.
English: - Zoledronic Acid Hospira 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
Maltese: - Zoledronic Acid Hospira 4 mg /100 ml soluzzjoni għall-infużjoni fih 4 mg zoledronic acid f'100 ml ta' soluzzjoni għall-infużjoni sabiex jintuża minnufih f'pazjenti bil-funzjoni tal-kliewi normali
English: Nasopharyngitis Gastrointestinal disorders Very common:
Maltese: Nasofarinġite Disturbi gastro-intestinali Komuni ħafna:
English: Concentrate for solution for infusion (sterile concentrate)
Maltese: Konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili)
English: Zoledronic Acid Hospira contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment “bla sodju”.
English: Zoledronic Acid Hospira with food and drink
Maltese: Zoledronic Acid Hospira ma' ikel u xorb
English: Scleritis and parophtalmia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Maltese: Ħafna minn dawn il-pazjenti kienu qed jirċievu wkoll kimoterapija u kortikosterojdi u kellhom sinjali ta' infezzjoni lokali inkluża ostejomajlite.
English: Osteonecrosis of the jaw (ONJ)
Maltese: Żmien tal-istudju (ġimgħat)
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Maltese: M'hemmx bżonn tibdil fid-doża f'pazjenti b'TIH li għandhom kreatinina fis-serum < 400 µmol/l jew < 4.5 mg/dl (ara sezzjoni 4.4).
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 cancer patients studied.
Maltese: It-tneħħija renali ta' zoledronic acid ġiet korrelata mat-tneħħija ta' kreatinina bi tneħħija renali li tirrappreżenta 75 ± 33% tat-tneħħija tal-kreatinina, li wriet medja ta' 84 ± 29 ml/min (minn 22 sa 143 ml/min) fl-64 pazjent bil-kanċer li kienu studjati.
English: − To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Hospira concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Maltese: - Biex tipprepara soluzzjoni għall-infużjoni ta' 4 mg ta' zoledronic acid, żid il-konċentrat ta' Zoledronic Acid Hospira (5.0 ml) ma' 100 ml ta' soluzzjoni għall-infużjoni ħielsa mill-kalċju jew minn soluzzjonijiet li jkun fihom divalent cations oħrajn.
English: Uncommon: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Maltese: Sturdament, parasteżija, disgewżja, ipoesteżija, iperesteżija, tregħid, ħedla ta' ngħas
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 doża inizjali ta' vitamina D qabel ma ngħataw zoledronic acid (ara sezzjoni 4.2).
English: • A single dose of zoledronic acid should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
Maltese: • Doża waħda 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: − The active substance of Zoledronic Acid Hospira is zoledronic acid.
Maltese: X'fih Zoledronic Acid Hospira - Is-sustanza attiva f'Zoledronic Acid Hospira hi zoledronic acid.
English: Table 6: Proportion of complete responders by day in the combined TIH studies Day 4
Maltese: Tabella 6: Proporzjon ta' pazjenti li rrispondew kompletament għall-kura skont il-ġurnata fl-istudji kkombinati ta' TIH
English: Zoledronic Acid Hospira should be given as a single intravenous infusion in no less than 15 minutes.
Maltese: Zoledronic Acid Hospira, għandu jingħata bħala infużjoni waħda għal ġol-vini f'mhux inqas minn 15-il minuta.
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 mogħtija tiġi rkuprata fl-awrina, filwaqt li l-bqijja tkun fil-parti l-kbira marbuta mat-tessut tal-għadam.
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid -treated group versus 49.6% in the placebo group (p=0.003).
Maltese: Il-proporzjon ta' pazjenti li almenu kellhom SRE wieħed (bl-esklużjoni ta' iperkalċimja) kienet 29.8% fil-grupp ikkurat b'zoledronic acid kontra 49.
English: Each bag with 100 ml of solution contains 4 mg zoledronic acid (as monohydrate).
Maltese: Kull borża b'100 ml ta' soluzzjoni fih 4 mg zoledronic acid (bħala monohydrate).
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing) Uncommon: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Maltese: Astenja, edima periferali, reazzjoni fis-sit tal-injezzjoni (li jinkludi uġigħ, irritazzjoni, nefħa, ebusija), uġigħ fis-sider, u żieda fil-piż, reazzjoni anafilattika/xokk anafilattiku, urtikarja
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Maltese: F'pazjenti b'indeboliment renali ħafif sa moderat, huma rrakkomandati dożi mnaqqsa ta' zoledronic acid (ara s-sezzjoni “Pożoloġija” hawn fuq u s-sezzjoni 4.4).
English: Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Maltese: Iż-żmien medjan sabiex beda l-ewwel SRE ma ntlaħaqx fil-fergħa kkurata b'zoledronic acid meta ntemm l-istudju u kien imtawwal b'mod sinifikanti meta mqabbel mal-plaċebo (p=0.007). Zoledronic acid 4 mg naqqas ir-riskju ta SRE's b'41% f'analiżi ta' ħafna avveniment (proporzjon tar-riskju=0.59, p=0.019) meta mqabbel mal-plaċebo.
English: Very rare Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Maltese: Osteonekrożi tal-kanal estern tas-smigħ (reazzjoni avversi għall-klassi bifosfonati) u siti anatomiċi oħrajn inkluż ksur tal-għadma tal-koxxa u tal-ġenbejn
English: − The other ingredients are: mannitol, sodium citrate, water for injections.
Maltese: - Is-sustanzi l-oħra huma: mannitol, sodium citrate, ilma għal injezzjonijiet.
English: Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Maltese: Zoledronic Acid Hospira 4 mg/100 ml soluzzjoni għall-infużjoni
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml dose of Zoledronic Acid Hospira, i.e. essentially “sodium free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodju (23 mg) f'kull doża ta' 100 ml Zelodronic Acid Hospira, jiġifieri essenzjalment hu “bla sodju”.
English: Radiation therapy to bone zoledronic acid
Maltese: Kif gћandek tieћu Zoledronic Acid Hospira
English: The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used.
Maltese: 4%, 10.7% wara l-ewwel, it-tieni u t-tielet infużjoni, rispettivament), fejn intużat profilassi kontra r-reazzjonijiet avversi.
English: Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Maltese: Zoledronic acid ma jimpedixxix l-enzimi tal-bniedem P450 in vitro, ma jurix bijotrasformazzjoni, u fi studji li saru fuq annimali, <3% tad-doża mogħtija nstabet fl-ippurgar, li jissuġġerixxi li l-funzjoni tal-fwied ftit li xejn għandha rwol rilevanti fil-farmakokinetika ta' zoledronic acid.
English: Zoledronic Acid Hospira 5 mg/100 ml solution for infusion
Maltese: Zoledronic Acid Hospira 5 mg/100 ml soluzzjoni għall-infużjoni
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibilitajiet, is-soluzzjoni ghall-infużjoni għandha tigi ddilwita b' sodium chloride 9 mg/m; (0.9%) jew 5% w/v soluzzjoni ta' glucose.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, reduced Zoledronic Acid Hospira doses are recommended (see also section 4.4).
Maltese: F'pazjenti b'metastasi fl-għadam li jkollhom indeboliment tal-kliewi ħafif għal moderat qabel tibda t-terapija, li għal din il-popolazzjoni titqies bħala CLcr 30-60 ml/min, id-dożi ta' zoledronic acid Hospira li ġejjin huma rrakkomandati (ara wkoll sezzjoni 4.4):
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Maltese: Id-deterjorament renali, il-progressjoni għall-insuffiċjenza renali u d-dijaliżi ġew irrapportati f'pazjenti wara d-doża tal-bidu jew wara doża waħda ta' 4 mg zoledronic acid (ara sezzjoni 4.4).
English: In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Maltese: Fi provi kliniċi fuq pazjenti b'żieda fil-livell tal-kalċju fid-demm minħabba tumuri (TIH), il-profil ta' sigurtà fost it-tliet gruppi ttrattati (zoledronic acid 4 mg u zoledronic acid 8 mg u pamidronate) kien tal-istess mil-lat ta' tipi u severità.
English: Pain in extremities, arthralgia, musculoskeletal pain General disorders and administration site conditions Very common:
Maltese: Uġigħ fl-idejn u s-saqajn, artralġja, uġigħ muskoluskeletriku Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Maltese: Il-perċentwali globali tal-pazjenti li ħassew reazzjonijet avversi kienu 44.7%, 16.7% u 10.
English: Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Maltese: (reazzjoni avversa tal-klassi tal-bisphosphonate)
English: - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Maltese: - Prevenzjoni ta' problemi skeletriċi (ksur patoloġiku, kompressjoni tas-sinsla, radjazzjoni jew kirurġija fl-għadam, jew żieda fil-livell ta' calcium fid-demm kawżat minn tumur) f'pazjenti adulti b'kanċer avvanzat li jinvolvi l-għadam.
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Maltese: Analiżi ta' ħafna avvenimenti f'daqqa wrew tnaqqis ta' 30.7% tar-riskju li wieħed jiżviluppa
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Hospira.
Maltese: - Jekk qed tiġi kkurat sabiex jitnaqqas l-ammont ta' kalċju fid-demm tiegħek, normalment tingħata biss infużjoni waħda ta' Zoledronic Acid Hospira.
English: Treatment of Paget's disease of the bone in adults.
Maltese: It-trattament tal-marda ta' Paget fl-għadam ta' adulti.
English: This uptake into bone is common for all bisphosphonates and is presumably a consequence of the structural analogy to pyrophosphate.
Maltese: Dan it-twaħħil ġewwa l-għadam huwa komuni għall-bisfosfonati kollha u huwa preżumibbilment konsegwenza tal-analoġija strutturali mal-pirofosfati.
English: Longer-term repeat administration at doses bracketing the highest intended human therapeutic dose of zoledronic acid produced toxicological effects in other organs, including the gastrointestinal tract, liver, spleen and lungs, and at intravenous injection sites.
Maltese: L-għotja ripetuta tal-mediċina fuq żmien itwal b'dożi li laħqu l-ogħla doża terapewtika ta' zoledronic acid intenzjonata għall-bniedem ikkawżat effetti tossikoloġiċi f'organi oħrajn, inkluż fis-sistema gastrointestinali, fil-fwied, fil-milsa u fil-pulmun, u fil-postijiet minn fejn ikunu ngħataw l-injezzjoniet ġol-vini.
English: Zoledronic Acid Hospira 5 mg/100 ml (to appear in roundel) solution for infusion Zoledronic acid
Maltese: Zoledronic Acid Hospira 5 mg/100 ml (biex jidher fir-roundel) soluzzjoni għall-infużjoni Zoledronic acid
English: - Zoledronic Acid Hospira is ready for use.
Maltese: - Zoledronic Acid Hospira hija lesta għall-użu.
English: Common Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue Common Myalgia, arthralgia, bone pain, back pain,
Maltese: Fi żmien tlett ijiem wara l-għoti ta' zoledronic acid, ġiet irrappurtata spiss reazzjoni ta' fażi akuta, b'sintomi li jinkludu uġigħ fl-għadam, deni, għeja, artralġja, mijalġja, tertir u artrite b'nefħa sussegwenti fil-ġogi; dawn is-sintomi normalment jgħaddu fi ftit ġranet (ara d-deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Each bag with 100 ml of solution contains 5 mg zoledronic acid anhydrous (as monohydrate).
Maltese: Kull borża b'100 ml ta' soluzzjoni fih 5 mg zoledronic acid anidru (bħala monohydrate).
English: Aseptic techniques must be followed during the preparation of the infusion.
Maltese: Waqt il-preparazzjoni tal-infużjoni, għandhom jiġu segwiti tekniki asettiċi.
English: Zoledronic Acid
Maltese: Doża ta' zoledronic acid rakkomandata*
English: B. PACKAGE LEAFLET
Maltese: PAKKETT WIEĦED
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Maltese: F'pazjenti b'majeloma multipla, ir-riskju ta' disfunzjoni tal-kliewi jista' jiżdied meta Zoledronic Acid Hospira jintuża flimkien ma' thalidomide.
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Maltese: Fi studji ta' Fazi I għat-tfittxija tad-doża li għandha tingħata f'pazjenti b'TIH ta' grad ħafif sa moderat, id-dożi effettivi li ġew ittestjati kienu fil-medda ta' madwar 1.2-2.5 mg.
English: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 mg dose - 3.8 ml for 3.0 mg dose
Maltese: Iġbed il-volum meħtieġ tas-soluzzjoni rrikostitwita (4 mg/5 ml), kif ġej: - 4.4 ml għal doża ta' 3.5 mg
English: Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.
Maltese: Uġigħ ta' ras, sturdament, dardir, rimettar, dijarea, uġigħ fil-muskoli, uġigħ fl-għadam u/jew fil-ġogi, uġigħ fid-dahar, fid-dirgħajn jew fir-riġlejn, sintomi bħal tal-influwenza (eż. għeja, tkexkix ta' bard, uġigħ fil-ġogi u fil-muskoli) tkexkix ta' bard, tħoss għeja u nuqqas ta' interess, dgħufija, uġigħ u tħossok ma tiflaħx, nefħa u/jew uġigħ fil-post tal-infużjoni.
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
English: Local reactions
Maltese: Reazzjonijiet lokali
English: − Sleepiness
Maltese: Tliet snin
English: Each ml of the solution contains 0.05 mg zoledronic acid anhydrous (as monohydrate).
Maltese: Kull millilitru tas-soluzzjoni fiha 0.05 mg zoledronic acid anhydrous (monoidrat).
English: One vial contains 4 mg zoledronic acid (as monohydrate).
Maltese: Borża waħda fiha 4 mg zoledronic acid (bħala monoidrat).
English: The onset time is 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Maltese: Iż-żmien ta' meta tibda huwa ≤3 ijiem wara l-infużjoni ta' zoledronic acid, u r-reazzjoni hija wkoll magħrufa bit-termini ta' sintomi “li jixbħu l-influwenza” jew “ta' wara d-doża”.
English: Remove the volume of Zoledronic Acid Hospira solution indicated from the bag prior to administration.
Maltese: Neħħi l-volum ta' soluzzjoni ta' Zoledronic Acid Hospira indikat mill-borża qabel l-għoti.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 5.1 imma l-ebda rakkomandazzjoni fuq il-pożoloġija ma tista' tingħata.
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Maltese: Biex tipprepara dożi mnaqqsa għall-pazjenti b'linja bażi ta' riferiment ta' CLer ≤ 60 ml/min, irreferi għal Tabella I hawn isfel.
English: In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted.
Maltese: F'pazjenti b'funzjoni tal-fwied normali, imfisser bħala CLer > 60 ml/min is-soluzzjoni għall-infużjoni ta' 4 mg/100 ml zoledronic acid m'għandux jiġi dilwit aktar.
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: Il-fatturi ta' riskju li ġejjin għandhom jiġu kkonsidrati meta jiġi evalwat r-riskju ta' individwu li jiżviluppa ONJ: - Il-qawwa tal-bisphosphonate (riskju ogħla għal komposti qawwija ħafna), mnejn jingħata (riskju ogħla għall-għoti parenterali) u doża kumulattiva ta' bisphosphonate.
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Maltese: Zoledronic acid mhux rakkomandat għall-pazjenti li jkollhom indeboliment sever tal-kliewi qabel tibda t-terapija, li għal din il-popolazzjoni hi meqjusa bħala CLcr <30 ml/min.
English: Talk to your doctor before you are given Zoledronic Acid Hospira: - if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Zoledronic Acid Hospira (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
Maltese: Kellem lit-tabib tiegħek qabel tingħata Zoledronic Acid Hospira: - jekk qed tingħata kura b'xi mediċina oħra li fiha zoledronic acid, li huwa wkoll is-sustanza attiva ta' Zoledronic Acid Hospira (zoledronic acid jintuża f'pazjenti adulti b'ċerti tipi ta' kanċers biex jipprevjeni kumplikazzjonijiet fl-għadam jew biex inaqqas l-ammont ta' kalċju).. - jekk għandek problema fil-kliewi jew xi darba kellek problema fil-kliewi.
English: A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
Maltese: Parti minnhom reġgħu ħarġulhom is-sintomi meta reġgħu ngħataw zoledronic acid jew bisphosphonate ieħor.
English: Paediatric patients
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Maltese: Fi studji kliniċi, il-kura b'zoledronic acid reġgħet inbdiet biss meta l-livell ta' kreatinina kien reġa' ġie lura għal 10 % tal-valur tal-linja bażi (ara sezzjoni 4.4).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu.
English: Each bag of 100 ml contains 5 mg zoledronic acid (as monohydrate).
Maltese: Borża waħda ta' 100 ml fiha 5 mg zoledronic acid (bħala monoidrat).
English: − Conjunctivitis.
Maltese: U KWANTITATTIVA
English: Table 4: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Maltese: Tabella 4: Riżultati ta' effikaċja (pazjenti b'tumuri solidi oħra barra dawk tas-sider u tal-prostata)
English: Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain
Maltese: Edema periferali, għatx, reazzjoni tal-fażi akuta, uġigħ fis-sider mhux ġej mill-qalb
English: − Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Maltese: - Ritmu irregolari tal-qalb (fibrillazzjoni tal-atrija) deher f'pazjenti li kienu qegħdin jingħataw zoledronic acid għall-osteoporożi ta' wara l-menopawża.