FrancophonIA/ELRC3.0 huggingface dataset:
English: − The diluted Zoledronic Acid Hospira infusion solution should be used immediately in order to avoid microbial contamination.
Maltese: - Is-soluzzjoni għall-infużjoni ta' Zoledronic Acid Hospira dilwita għandha tintuża minnufih sabiex jiġi evitat li jkun hemm kontaminazzjoni bil-mikrobi.
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 parenterali 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 jew ogħla mill-ogħla dożi terapewtiċi intenzjonati għall-bniedem.
English: Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Maltese: Analiżi tal-popolazzjoni wriet li għal pazjenti bi tneħħija tal-kreatinina ta' 20 ml/min (indeboliment sever tal-kliewi), jew 50 ml/min (indeboliment moderat), it-tneħħija ta' zoledronic acid li jikkorrispondi kien imbassar li jkun 37% jew 72%, rispettivament meta mqabbla ma' pazjenti bi tneħħija tal-kreatinina ta' 84 ml/min.
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 ta' kuljum ta' 30 mg risedronate għal xahrejn intweriet f'żewġ provi komparattivi li damu 6 xhur.
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: Other products containing zoledronic acid as active substance are available for oncology indications.
Maltese: Prodotti oħrajn li fihom iz-zoledronic acid bħala sustanza attiva huma disponibbli għal indikazzjonijiet onkoloġiċi.
English: Mannitol, sodium citrate and water for injections.
Maltese: Mannitol, sodium citrate u ilma għall-injezzjonijiet
English: Uncommon Cough, dyspnoea
Maltese: Mhux komuni Sogħla, dispnea
English: In patients with mild to moderate renal impairment, reduced Zoledronic Acid Hospira doses are recommended (see section “Posology” above and section 4.4).
Maltese: F'pazjenti b'indeboliment ħafif għal moderat, tnaqqis fid-dożi ta' Zoledronic Acid Hospira huwa rakkomandat (ara s-sezzjoni “Pożoloġija” hawn fuq u s-sezzjoni 4.4).
English: The following conventional classification is used: 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 (cannot be estimated from the available data).
Maltese: Qiegħda tintuża l-klassifikazzjoni konvenzjonali li ġejja: komuni ħafna (1/10), komuni (1/100 sa <1/10), mhux komuni (1/1,000 sa <1/100), rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic Acid Hospira.
Maltese: Il-probabbilità li tħoss dawn leffetti sekondarji tonqos bid-dożi ta' Zoledronic Acid Hospira sussegwenti.
English: Investigations Very common:
Maltese: Investigazzjonijiet Komuni ħafna:
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Maltese: Ir-rata ta' każijiet avversi serji ta' fibrillazzjoni atrijali żdiedet f'pazjenti li kienu qed jirċievu zoledronic acid (1.3%) (51 minn 3,862) meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo (0.6%) (22 minn 3,852).
English: Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Maltese: Qabel l-għoti, 5 ml konċentrat minn kunjett wieħed jew il-volum ta' konċentrat miġbud kif meħtieġ għandu jiġi dilwit aktar b'100 ml ta' soluzzjoni għall-infużjoni li ma jkunx fiha l-kalċju (9 mg/ml (0.9%) soluzzjoni ta' sodium chloride jew 5% w/v soluzzjoni ta' glucose għall-injezzjoni).
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Maltese: Arritmiji tal-qalb u avvenimenti newroloġiċi avversi (inkluż konvulżjonijiet, ipoesteżija u tetanja) ġew irrappurtati kawża ta' każijiet ta' ipokalċimija qawwija.
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 (cannot be estimated from the available data).
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 (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli.
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: - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures, e.g. tooth extractions.
Maltese: - Storja ta' mard dentali, iġene orali fjakka, mard perjodontali, proċeduri dentali invażivi (eż. qlugħ ta' snien) u dentaturi li ma ġewx imqegħda tajjeb.
English: Figure 1: Mean changes from baseline in BPI scores.
Maltese: Figura 1: Medja tal-bidliet mill-linja bażi fil-punteġġi BPI.
English: ONJ has been reported in the post-marketing setting in patients receiving zoledronic acid for osteoporosis (see section 4.8).
Maltese: Kienet irrapportata ONJ f'kuntest wara t-tqegħid fis-suq f'pazjenti li jingħataw zoledronic acid għallosteoporożi (ara sezzjoni 4.8).
English: For information on the infusion of Zoledronic Acid Hospira, see section 6.6.
Maltese: Għal aktar tagħrif dwar l-infużjoni ta' Zoledronic Acid Hospira ara sezzjoni 6.6.
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Maltese: L-ewwel studju każwali, double-blind u kkontrollat bi plaċebo qabbel zoledronic acid 4 mg ma' plaċebo fil-prevenzjoni ta' effetti marbuta mal-iskeletru (SRE-skeletal related events) f'pazjenti b'kanċer tal-prostata.
English: Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
Maltese: Pazjenti fuq kura b'zoledronic acid 4 mg rrapurtaw inqas żieda fl-uġigħ minn dawk li kienu fuq plaċebo, u d-differenza kienet sinifikanti fit-3, 9, 21 u 24 xhar.
English: Pancytopenia Immune system disorders Uncommon: Hypersensitivity reaction Rare:
Maltese: Panċitopenja Disturbi fis-sistema immuni Mhux komuni:
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects)
Maltese: Ġew irrappurtati każijiet rari ta' insuffiċjenza renali li teħtieġ dijaliżi u każijiet rari li kellhom riżultat fatali f'pazjenti li diġà jkollhom disfunzjoni tal-kliewi jew xi fatturi oħra ta' riskju fosthom l-età avvanzata, prodotti mediċinali nefrotossiċi konkomitanti, terapija dijuretika konkomitanti jew deidrazzjoni fil-perjodu ta' wara l-infużjoni (ara l-effetti skont ilklassi f'sezzjonijiet 4.4 u 4.8)
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: This medicine contains 16 mmol (or 360 mg) sodium per dose.
Maltese: Din il-mediċina fiha 16 mmol (jew 360 mg) ta' sodju f'kull doża.
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 imperfecta severa, zoledronic acid jidher li huwa assoċjat ma' riskji jispikkaw aktar għal reazzjonijiet tal-fażi akuta, ipokalċimija u takikardija mingħajr spjegazzjoni, meta mqabbel ma' pamidronate, iżda din id-differenza naqset wara infużjonijiet sussegwenti.
English: Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Maltese: Zoledronic acid ma jiġix metabolizzat u jiġi eliminat fi stat mhux mibdul mill-kliewi.
English: tremor, syncope, dysgeusia
Maltese: Tħeddil, parasteżija, ngħas, tregħid, sinkope, disgewżja
English: Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
Maltese: Ipofosfatimija Reazzjonijiet avversi li seħħew bi frekwenzi <5% kienu stmati b'mod mediku u ntwera li dawn il-każijiet kienu konsistenti mal-profil magħruf ta' sigurtà ta' zoledronic acid (ara sezzjoni 4.8).
English: The use of Zoledronic Acid Hospira in children and adolescents has not been studied.
Maltese: L-użu ta' Zoledronic Acid Hospira fi tfal u adolexxenti ma kienx studjat.
English: - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Maltese: - It-terapiji konkomitanti: kortikosterojdi, kimoterapija, inibituri tal-anġjoġenesi, radjuterapija għar-ras u għall-għonq.
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for the treatment of postmenopausal osteoporosis.
Maltese: Ritmu tal-qalb irregolari (fibrillazzjoni atrijali) dehret f'pazjenti mogħtija zoledronic acid għattrattament ta' osteoporożi postmenopawżali.
English: Interstitial lung disease Gastrointestinal disorders Common:
Maltese: Mard interstizzjali tal-pulmun Disturbi gastro-intestinali
English: The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
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 għal għoti parenterali) u doża kumulattiva ta' bisphosphonate.
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 Hospira.
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 Hospira.
English: You may eat normally on the day you are treated with Zoledronic Acid Hospira.
Maltese: Tista' tiekol normali dakinhar meta qed tingħata t-trattament b'Zoledronic Acid Hospira.
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 kienux jiddependu fuq id-doża.
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: Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
Maltese: Ksur subtrochanteric u diaphyseal mhux tipiku tal-għadma tal-wirk†
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Maltese: Tabella 2:Riżultati ta' effikaċja (pazjenti b'kanċer tal-prostata li qed jieħdu kura b'ormoni) Kwalunkwe SRE (+TIH)
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: In the zoledronic acid -treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Maltese: Fil-grupp ikkurat b'zoledronic acid, titjib statistikament sinifikanti fil-punteġġi tal-uġigħ (permezz tal-Brief Pain Inventory, BPI) deher mar-4 ġimgħa u ma' kull punt sussegwenti waqt l-istudju, meta mqabbel mal-plaċebo (Figura 1).
English: Zoledronic Acid Hospira is supplied as packs containing 1 vial.
Maltese: Zoledronic Acid Hospira jiġi f'pakketti li jkun fihom kunjett 1.
English: Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Maltese: Riżultati ta' prova klinika fil-kura ta' osteoġenesi imperfecta severa f'pazjenti pedjatriċi mill-età ta' sena sa 17-il sena
English: Table 1: Preparation of reduced doses of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Maltese: Tabella 1: Preparazzjoni ta' dożi mnaqqsa ta' soluzzjoni ta' 4 mg/100 ml Zoledronic Acid Hospira għall-infużjoni.
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Maltese: Fi prova ta' III fażi double-blind u b'pazjenti magħżula , 4 mg ta' zoledronic acid jew 90 mg ta' pamidronate, mogħtija kull 3 sa 4 gimgħat ġew imqabbla f'pazjenti b'majeloma multipla jew kanċer tas-sider li kellhom mill-inqas leżjoni waħda fl-għadam.
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: li kienet manifestata bħala tħażżin fil-funzjoni renali (jiġifieri żieda tal-kreatinina fis-serum) u f'każijiet rari indeboliment renali akuta.
English: One ml solution contains 0.05 mg zoledronic acid (as monohydrate).
Maltese: Millilitru wieħed ta' soluzzjoni fih 0.05 mg zoledronic acid (bħala monohydrate).
English: Placebo zoledronic acid
Maltese: Plaċebo Δ Zoledronic Acid 
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, b'individwi magħżula b'mod każwali, kontrollata bi plaċebo f'228 pazjent b'metastasi tal-għadam dokumentata minn kanċer tas-sider sabiex ikun evalwat l-effett ta' 4 mg ta' zoledronic acid fuq ir-rata tal-proporzjon tal-każijiet relatati malgħadam (SRE), kalkulat bħala n-numru totali ta' każijiet ta' SRE (bl-esklużjoni ta' iperkalċimja u rranġata għall-qabel il-ksur), diviż mat-totali tal-perijodu ta' riskju.
English: Each pack contains one bag.
Maltese: Kull pakkett fih borża waħda.
English: After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of zoledronic acid on day 28.
Maltese: Wara li nbdiet l-infużjoni ta' zoledronic acid, il-konċentrazzjoni ta' zoledronic acid fil-plażma telgħet malajr ħafna u laħqet l-ogħla livelli ma' tmiem l-infużjoni u minn hemm 'l quddiem naqset malajr għal < 10% tal-ogħla livelli wara 4 sigħat u <1% tal-ogħla livell wara 24 siegħa, u wara dan kien hemm perijodu twil fejn il-konċentrazzjoni kienet baxxa ħafna, mhux aktar minn 0.1% tal-ogħla livell sa ma kienet tmiss it-tieni infużjoni ta' zoledronic acid fit-28 jum.
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 tal-uġigħ meta mqabbel mal-linja bażi kien osservat fuq 6 xhur għal zoledronic acid u risedronate.
English: (included in section 1 text)
Maltese: (inkluż fit-test ta' sezzjoni 1)
English: Other medicines and Zoledronic Acid Hospira
Maltese: Mediċini oħra u Zoledronic Acid Hospira
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: somnolence
Maltese: Pożoloġija
English: The following adverse reactions, listed in Table 1, 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 1 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: One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Maltese: Millilitru wieħed fih 0.8 mg zoledronic acid (bħala monohydrate)
English: • Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each Zoledronic Acid Hospira dose.
Maltese: • It-tneħħija tal-kreatinina għandha titkejjel skont il-piż attwali tal-ġisem billi tintuża l-formula Cockcroft-Gault qabel kull doża ta' Zoledronic Acid Hospira.
English: One ml solution contains 0.04 mg zoledronic acid (as monohydrate).
Maltese: Millilitru wieħed ta' soluzzjoni fih 0.04 mg zoledronic acid (bħala monohydrate).
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' calcium, phosphorous u magnesium) u/jew bidliet fil-funzjoni tal-kliewi, inkluża insuffiċjenza severa tal-kliewi.
English: Zoledronic Acid Hospira 4 mg/100 ml solution for infusion Zoledronic acid
Maltese: Zoledronic acid Hospira 4 mg/100 ml soluzzjoni għall-infużjoni Zoledronic acid
English: Zoledronic Acid Hospira 5 mg/100 ml solution for infusion Zoledronic acid
Maltese: Zoledronic acid Hospira 5 mg/100 ml soluzzjoni għall-infużjoni Zoledronic acid
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Maltese: L-għoti ta' dożi sa 48 mg ta' zoledronic acid bi żball ġew irrapportati.
English: Statistically significant differences are marked (*p<0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Maltese: Differenzi statistikament sinifikanti huma mmarkati (*p<0.05) għat-tqabbil bejn kura u oħra.
English: Conjunctivitis
Maltese: Komuni
English: Other products containing zoledronic acid as active substance are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Maltese: Prodotti oħra li fihom zoledronic acid bħala s-sustanza attiva huma disponibbli għal indikazzjonijiet ta' osteoporożi u għat-trattament tal-marda tal-għadam ta' Paget.
English: 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 ġie studjat 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 ta' 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: Special populations (see section 4.2)
Maltese: Popolazzjonijiet speċjali (ara sezzjoni 4.2)
English: - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Maltese: - Kanċer, kundizzjonijiet li fl-istess waqt idgħajfu lill-pazjent (eż. anemija, mard talkoagulazzjoni, infezzjoni), it-tipjip.
English: Zoledronic Acid Hospira is contraindicated during breast-feeding (see section 4.3).
Maltese: Zoledronic acid huwa kontraindikat f'nisa li qed ireddgħu (ara sezzjoni 4.3).
English: Pfizer SA/NV Tél/Tel: +32 2 554 62 11
Maltese: Pfizer Polska Sp. z o.o. Tel: +48 22 335 61 00
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra u forom ora ta' interazzjoni
English: Angioneurotic oedema
Maltese: Ir-Renju Unit
English: What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is supplied as a liquid concentrate (referred to as a ‘concentrate for solution for infusion' or ‘sterile concentrate') in a vial.
Maltese: Kif jidher Zoledronic Acid Hospira u l-kontenut tal-pakkett Zoledronic Acid Hospira jiġi bħala konċentrat likwidu (magħruf bħala konċentrat għal soluzzjoni għall-infużjoni' jew ‘konċentrat sterili') f'kunjett.
English: It also contains mannitol, sodium citrate, water for injections and sodium chloride.
Maltese: Fiha wkoll mannitol, sodium citrate, ilma għall-injezzjonijiet u sodium chloride.
English: − Low blood pressure.
Maltese: - Pressjoni baxxa.
English: A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Maltese: Disturb tal-funzjoni tal-kliewi msejjaħ is-sindrome Fanconi (normalment se jkun iddeterminat mit-tabib tiegħek permezz ta' ċerti testijiet tal-awrina).