FrancophonIA/ELRC3.0 huggingface dataset:
English: In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Maltese: Fl-istudji kliniċi, pazjenti li kellhom kreatinina fis-serum ta' >400 µmol/l jew >4.5 mg/dl kienu esklużi.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini:http://www.ema.europa.eu
English: Zoledronic Acid Accord contains the same active substance as found in Aclasta (zoledronic acid).
Maltese: Zoledronic Acid Accord fih l-istess sustanza attiva li tinsab f'Aclasta (zoledronic acid).
English: • As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Maltese: • Bħala konsegwenza ta' valuri baxxi tal-kalċju: taħbit irregolari tal-qalb (arritmija tal-qalb;
English: • Skin reactions (redness and swelling) at the infusion site, rash, itching.
Maltese: • Reazzjonijiet fil-ġilda (ħmura u nefħa) fis-sit tal-infużjoni, raxx, ħakk.
English: Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Maltese: Hemm biss tagħrif farmakokinetiku limitat f'pazjenti b'insuffiċjenza severa tal-kliewi (tneħħija talkreatinina< 30 ml/min).
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention:
Maltese: Ir-reazzjonijiet avversi qegħdin imqassmin taħt it-titlu tal-frekwenza, l-aktar frekwenti l-ewwel, bilkonvenzjoni li ġejja:
English: The following risk factors should be considered when evaluating an individual's risk of developing ONJ:
Maltese: Il-fatturi ta' riskju li ġejjin għandhom jiġu kkunsidrati meta jiġi evalwat ir-riskju ta' individwu li jiżviluppa ONJ:
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Maltese: F'ġabra ta' analiżijiet dwar issigurtà waqt il-provi ta' reġistrazzjoni ta' zoledronic acid għall-prevenzjoni ta' problemi skelettriċi f'pazjenti li għandhom kanċer avanzat li jinvolvi l-għadam, il-frekwenza ta' episodji avversi ta' indeboliment tal-kliewi li jistgħu jkunu relatati ma' zoledronic acid (reazzjonijiet avversi) kienet kif ġej: maeloma multipla (3.2%), kanċer tal-prostata (3.1%), kanċer tas-sider (4.3%), tumuri tal-pulmun u tumuri solidi oħrajn (3.2%).
English: Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Maltese: Differenzi statistikament sinifikanti huma mmarkati (*p<0.05) għat-tqabbil bejn kura u oħra.
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Maltese: Indeboliment tal-funzjoni renali, osteonekrożi tax-xedaq, reazzjoni ta' fażi akuta, ipokalċimija, avvenimenti avversi fl-għajnejn, fibrillazzjoni tal-atrija, anafilassi.
English: In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 µmol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 µmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
Maltese: Minħabba l-impatt potenzjali ta' zoledronic acid fuq il-funzjoni tal-kliewi, u minħabba nuqqas ta' tagħrif kliniku dwar is-sigurtà f'pazjenti b'indeboliment sever tal-kliewi (iddefinit fi provi kliniċi bħala livell ta' kreatinina fis-serum ta' 400 µmol/l jew 4.5 mg/dl għal pazjenti b'TIH u 265 µmol/l jew 3.0 mg/dl għal pazjenti b'kanċer u metastasi fl-għadam, rispettivament) fil-linja bażi u minħabba t-tagħrif farmakokinetiku limitat f'pazjenti li fil-linja bażi għandhom indeboliment sever fil-funzjoni tal-kliewi (tneħħija tal-kreatinina<30 ml/min), l-użu ta' zoledronic acid f'pazjenti b'indeboliment sever fil-funzjoni tal-kliewi mhux irrakkomandat.
English: In paediatric patients with severe osteogenesis imperfecta, zoledronic acid seems to be associated with more pronounced risks for acute phase reaction, hypocalcaemia and unexplained tachycardia, in comparison to pamidronate, but this difference declined after subsequent infusions.
Maltese: F'pazjenti pedjatriċi b'osteoġenesi imperfetta severa, zoledronic acid jidher li huwa assoċjat ma' riskji li jispikkawl-aktar bħalareazzjonijiet tal-fażi akuta, ipoklaċimija u takikardija mingħajr spjegazzjoni, meta mqabbel ma' pamidronate, iżda din id-differenza naqset wara infużjonijiet sussegwenti.
English: Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Maltese: kimoterapija, inibituri tal-anġjoġenesi (ara sezzjoni 4.5), radjoterapijagħar-ras u għall-għonq, kortikosterojdi.
English: Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Maltese: Ma jidhirx li zoledronic acid jeħel b'xi mod apprezzabbli mal-proteini fil-plażma u mhuwiex impeditur tal-enzima umana P450 in vitro (ara sezzjoni 5.2), biss ma sarux studji kliniċi formali dwar l-effett ta' mediċini jew ta' affarijiet oħra fuq l-effett farmaċewtiku tal-prodott.
English: History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures
Maltese: Storja ta' mard dentali, iġjene orali dgħajfa, mard perjodontali, proċeduri dentali invażivi (eż. qlugħ ta' snien)u dentaturi li ma jeħlux tajjeb
English: • Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
Maltese: • Mard tal-pulmun interstizjali (infjammazzjoni tat-tessut madwar il-boroż tal-arja tal-pulmuni)
English: • The other ingredients are: mannitol, sodium citrate, water for injections.
Maltese: - Is-sustanzi l-oħra huma: mannitol, sodium citrate, ilma għall-injezzjonijiet.
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Maltese: L-ammont miġbud tal-konċentrat għandu jkompli jiġi dilwit f'100 ml ta' soluzzjoni sterili ta' 0.9% w/v sodium chloride jew 5% w/v soluzzjoni ta' glucose.
English: • Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zoledronic Acid Accord.
Maltese: • Fi studji li saru b'diversi tipi ta' pajpijiet għall-infużjoni magħmulin minn polyvinyl chloride, polyethylene u polypropylene ma deherx li kien hemm xi inkompatibbiltà ma' Zoledronic Acid Accord.
English: The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Maltese: Fi studji fl-annimali fuq tul ta'żmien b'dożi parentali ripetuti, il-marġini tas-sigurtà relattivi mal-effetti fil-kliewi kienu żgħar imma l-livelli kumulattivi ta' mingħajr avvenimenti avversi (NOAELs) fi studji b'doża waħda (1.6 mg/kg) u studji b'dożi multipli meħudin sa xahar (0.06-0.6 mg/kg/jum) ma indikawx effetti fil-kliewi f'dożi ekwivalenti għal jewogħla mill-ogħla dożi terapewtiċi intenzjonati għall-bniedem.
English: • High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea constipation,
Maltese: • Pressjoni għolja, qtugħ ta' nifs, sturdament, ansjeta,disturb fl-irqad, disturbi fit-togħma,
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 tal-kalċjufid-demm (livell ta' kalċju fis-serum korrett għall-albumina 12.0 mg/dl jew 3.0 mmol/l) hija doża singola ta' 4 mg zoledronic acid.
English: MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Accord Healthcare S.L.U.
English: You will be given adequate calcium and vitamin D supplements.
Maltese: Inti se tingħata supplimenti adegwati ta' kalċjuu vitaminaD.
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Maltese: Fil-programm kliniku pazjenti li l-età tagħhom kienet minnsena sa <3 snin irċivew 0.025 mg/kg zoledronic acid (sad-doża waħda massima ta' 0.35 mg) kull 3 xhur u pazjenti li l-età tagħhom kienet minn 3 snin sa 17-il sena rċivew 0.05 mg/kg zoledronic acid (sad-doża waħda massima ta' 0.83 mg) kull 3 xhur.
English: To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibbiltajiet potenzjali, il-konċentrat ta' Zoledronic Acid Accord għandujiġi ddilwitb'0.9% w/v soluzzjoni għall-Injezzjoni ta' sodium chloride jew b'5% w/v soluzzjoni ta' glucose.
English: Common (1/100 to <1/10)
Maltese: Komuni ( 1/100 sa < 1/10)
English: Common ( 1/100 to < 1/10)
Maltese: Komuni (1/100 sa <1/10)
English: Additional information on handling of Zoledronic Acid Accord, including guidance on preparation of reduced doses, is provided in section 4.2.
Maltese: Informazzjoni addizzjonali dwar l-immaniġġar ta' Zoledronic Acid Accord, inkluż gwida dwar ilpreparazzjoni ta' dożi mnaqqsa hija pprovduta fis-sezzjoni 4.2.
English: • Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Maltese: • Aminoglikosidi (mediċini li jintużaw għall-kura ta' infezzjonijiet severi), calcitonin(tip ta' mediċina użata biex tikkura l-osteoporożiwara l-menopawsa uiperkalċimija), dijuretiċiloop(tip ta' mediċina biex tikkurapressjoni għoljajewedima) jewmediċini oħrali jbaxxul-kalċju,minħabba li meta jingħataw flimkien ma' bisfosfonati jistgħu jniżżlu l-livell tal-kalċju fid-demm għal wieħed baxx wisq.
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Maltese: Zoledronic acid huwa kontraindikat f'nisa li qed ireddgħu (ara sezzjoni 4.3).
English: • Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Maltese: • Uġigħ ta' ras u sindrome bħal tal-influwenza b'deni, għeja, debbulizza, ngħas, tkexkix ta' bard u uġigħ fl-għadam, fil-ġogi u/jew fil-muskoli.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic Acid Accord 4 mg/5 ml sterile concentrate zoledronic acid
Maltese: U MNEJN GĦANDU JINGĦATA Zoledronic Acid Accord 4 mg/5 ml konċentrat sterili Zoledronic acid
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Maltese: Tabella 2: Riżultati li juru l-effikaċja (pazjenti b'kanċer tal-prostata li qed jieħdu kura b'ormoni)
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: 87 sigħat, segwit minn fażi ta' eliminazzjoni twila b'half--life ta' eliminazzjoni terminali ta' t½γ146 sigħat.
English: Single and multiple 5- and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients with bone metastases yielded the following pharmacokinetic data, which were found to be dose independent.
Maltese: Infużjonijiet ta' darba jew multipli fuq medda ta' 5-minuti u 15-il minuta, u f'dożi ta' 2,4,8, u 16 mg ta' zoledronic acid f'64 pazjent b'metastasi fl-għadam, taw tagħrif farmakokinetiku hekk kif ġej, u li nstab li ma kinux jiddependu fuq id-doża.
English: Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Maltese: 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: Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Maltese: Zoledronic acid 4 mg kien studjat ukoll fi prova double-blind, randomizzata, ikkontrollata bi plaċebo f'228 pazjent b'metastasi tal-għadam iddokumentata minn kanċer tas-sider sabiex ikun evalwat l-effett ta' 4 mg ta' zoledronic acid fuq ir-rata tal-proporzjon tal-każijiet relatati mal-għadam (SRE), ikkalkulat bħala n-numru totali ta' każijiet ta' SRE (bl-esklużjoni ta' iperkalċimija u rranġata għallqabel il-ksur), diviż mat-totali tal-perjodu ta' riskju.
English: Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Maltese: Pazjenti li ngħataw dożi ogħla minn dawk irrakkommandati (ara sezzjoni 4.2) għandhom jiġu mgħassa bir-reqqa peress li dehru indeboliment talfunzjoni renali (inkluża insuffiċjenza renali) u anormalitajiet tal-elettroliti fis-serum (inklużi kalċju, fosfru u manjesju).
English: Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodotti mediċinali li jingħataw b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Hyperkalaemia, hypernatraemia
Maltese: Tqalligħ, rimettar, anoressija
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Maltese: Tabella 4: Riżultati li juru l-effikaċja (pazjenti b'kanċer fis-sider jew b'maeloma multipla)
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 ukellhom sinjali ta' infezzjoni lokali inkluż osteomaelitis.
English: This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Maltese: Din ir-reazzjoni avversa kontra l-mediċina tikkonsisti f'sensiela ta' sintomi li jinkludu deni, mijalġja, uġigħ ta' ras, uġigħ fl-estremitajiet, nawżja, rimettar, dijarea, altralġja u artrite b'nefħa sussegwenti filġogi.
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Maltese: , titrix u tetanja (kawża ta' ipokalċimija)
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Maltese: Zoledronic acid jista' jerġa' jingħata meta l-kreatinina fis-serum terġa' lura għal 10% tal-linja bażi.
English: Concentrate for solution for infusion 1 vial
Maltese: Konċentrat għal soluzzjoni għall-infużjoni 1 wieħed
English: One vial contains 4 mg zoledronic acid (as monohydrate).
Maltese: Kunjett wieħed fih 4 mg zoledronic acid (bħala monoidrat).
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.
English: • Chemical and physical in-use stability has been demonstrated for 36 hours at 2 - 8 °C.
Maltese: • L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 36 siegħa f'2 - 8 °C.
English: Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Maltese: Zoledronic Acid Accord 4 mg/5 mt konċentrat għal soluzzjoni għall-infużjoni Zoledronic acid
English: • To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Accord concentrate (5ml) 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, erġa' ddilwixxi lkonċentrat ta' Zoledronic Acid Accord (5 ml) ma' 100 ml soluzzjoni għall-infużjoni ħielsa millkalċjujew minn soluzzjonijiet li jkun fihom divalent cations oħrajn.
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 mill-kliewita' zoledronic acid ġiet ikkorrelatata mat-tneħħija ta' kreatinina bi tneħħija millkliewili 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: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Maltese: Arritmiji tal-qalb u avvenimenti newroloġiċi avversi (inkluż aċċessjonijiet, titrix u tetanja) ġew irrappurtati kawża ta' każijiet ta' ipokalċimija qawwija.
English: Uveitis
Maltese: Tqala
English: - Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6)
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal bisfosfonatioħra jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: Uncommon ( 1/1.000 to < 1/100)
Maltese: Mhux komuni ( 1/1,000 sa < 1/100)
English: Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Maltese: Zoledronic Acid Accord 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni Zoledronic acid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Maltese: U KWANTITATTIVA Kunjett wieħed b'5 ml konċentrat fih 4 mg zoledronic acid (bħala monoidrat).
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 kull 3-4 ġimgħat f'pazjenti tal-onkoloġija.
English: • The active substance is zoledronic acid.
Maltese: X'fih Zoledronic Acid Accord - Is-sustanza attiva hi zoledronic acid.
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Maltese: Taħbit irregolari tal-qalb (arritmija tal-qalb), aċċessjonijiet, spażmu u ġbid tal-muskoli għall-għarrieda (tetanja) ġew irrappurtati kawża ta'ipokalċimija qawwija.
English: Mannitol (E421) Sodium citrate Water for injections
Maltese: Mannitol(E421)
English: • The usual single dose given is 4 mg zoledronic acid.
Maltese: • Id-doża waħda tas-soltu mogħtija hija ta' 4 mgzoledronic acid.
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 għallinsuffiċjenza renali u d-dijaliżi ġew irrappurtati f'pazjenti wara d-doża tal-bidu jew wara doża waħda ta' 4 mg zoledronic acid (ara sezzjoni 4.4).
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: Median time to SRE (days)
Maltese: Kwalunkwe SRE (+TIH)
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Maltese: Dan għaliex tista' tiżviluppa anormalitajiet tal-elettroliti fis-serum (eż. livelli anormali ta' kalċju, fosfruu manjesju) u/jew bidliet fil-funzjoni tal-kliewi, inkluża insuffiċjenza severa tal-kliewi.
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, the following zoledronic acid dose is recommended (see also section 4.4):
Maltese: F'pazjenti b'metastasi tal-għadam li jkollhom indeboliment tal-kliewi ħafif għal moderat qabel tibda tterapija, li għal din il-popolazzjoni titqies bħala CLcr 30-60 ml/min, id-doża ta' zoledronic acid li ġejja hi rrakkomandata (ara wkoll sezzjoni 4.4):
English: Instructions for preparing reduced doses of Zoledronic Acid Accord: Withdraw the appropriate volume of the liquid concentrate, as follows: o 4.4 ml for 3.5 mg dose o 4.1 ml for 3.3 mg dose o 3.8 ml for 3.0 mg dose
Maltese: o 4.4 ml għal doża ta' 3.5 mg o 4.1 ml għal doża ta' 3.3 mg o 3.8 ml għal doża ta' 3.0 mg
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: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104)
English: How much Zoledronic Acid Accord is given
Maltese: Doża ta' zoledronic acid rrakkomandata*
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic Acid .
Maltese: Barra dan, kien hemm rapporti sporadiċi ta' osteonekrożi ta' siti oħra, inklużi l-ġenbejn u l-wirk, irrappurtati l-aktar f'pazjenti adulti bil-kanċer ittrattati b' Zoledronic Acid.
English: It is used:
Maltese: In vivo:
English: Zoledronic Acid Accord 4 mg concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Maltese: Zoledronic Acid Accord 4 mg konċentrat għal soluzzjoni għall-infużjoni, dilwit aktar f'100 ml (ara sezzjoni 6.6), għandujingħata bħala infużjoni waħda għal ġol-vini f'mhux inqas minn 15-il minuta.