FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare (may affect up to 1 in 1,000 people): - 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: Manufacturer Sanochemia Pharmazeutika AG
Maltese: GĦAMLA FARMAĊEWTIKA
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Maltese: Pressjoni għolja, pressjoni baxxa, fibrillazzjoni atrijali, pressjoni baxxa li twassal għal sinkope jew kollass ċirkolatorju Bradikardija, arritmija tal-qalb (kawża ta' ipokalċimija)
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 li kienu qed jirċievu zoledronic acid 4 mg irrappurtaw inqas żieda fl-uġigħ minn dawk li kienu qed jirċievu plaċebo, u d-differenza laħqet livell sinifikanti fit-3, 9, 21 u 24 xahar.
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphopsphonate class adverse reaction).
Maltese: Ksur atipiku subtrokanteriku u dijafiseali fil-qasba tas-sieq (reazzjoni avversa tal-klassi ta' bisfosfonat).
English: What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as solution for infusion in a 100 ml colourless glass bottle (type I) with rubber stoppers (halobutyl, fluoropolymer coated) and aluminium flip-off caps.
Maltese: Kif jidher Zoledronic acid medac u l-kontenut tal-pakkett Zoledronic acid medac hu fornut bħala soluzzjoni għall-infużjoni fi flixkun tal-ħġieġ (ta' tip I), ta' 100 ml, bla kulur, b'tappijiet tal-lastku (halobutyl, miksi bil-fluoropolymer) u siġill tat-tip flip-off talaluminju.
English: In the clinical trials, renal deterioration was defined as follows:
Maltese: Fil-provi kliniċi, iddeterjorament tal-funzjoni tal-kliewi ġie definit kif ġej:
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: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Maltese: Sturdament, parastesija, disgewżja, ipoestesija, iperestesija, rogħda, ngħas Konvulżjonijiet, ipoestesija u tetanja (kawża ta' ipokalċimija)
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 medac.
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 medac.
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-għoti ripetut fuq żmien itwal b'dożi li laħqu l-ogħla doża terapewtika ta' zoledronic acid intenzjonata għall-bniedem, ipproduċa effetti tossikoloġiċi f'organi oħrajn, inkluż fil-passaġġ gastrointestinali, fil-fwied, fil-milsa u fil-pulmun, u f'siti minn fejn tingħata l-injezzjoni ġol-vini.
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' każijiet multipli wriet tnaqqis ta' 30.7 % fir-riskju li wieħed jiżviluppa
English: One bottle contains 100 ml of solution.
Maltese: Kull flixkun fih 100 ml ta' soluzzjoni.
English: What Zoledronic acid medac contains - The active substance is zoledronic acid.
Maltese: − Is-sustanza attiva hi zoledronic acid.
English: Zoledronic acid medac 4 mg/5 ml 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 medac 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni, iddilwit b'mod addizzjonali f'100 ml (ara sezzjoni 6.6), għandu jingħata bħala infużjoni waħda ġol-vini f'mhux inqas minn 15-il minuta.
English: LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate, water for injections.
Maltese: − Is-sustanzi mhux attivi l-oħra huma: mannitol, sodium citrate, ilma għall-injezzjonijiet.
English: Within three days after zoledronic acid administration, an acute phase reaction has 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: Fi żmien tlett ijiem wara l-għoti ta' zoledronic acid, ġiet irrappurtata b'mod reazzjoni ta' fażi akuta, b'sintomi li jinkludu wġigħ 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: The multiple event analysis revealed a significant risk reduction of 16% in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate.
Maltese: L-analiżi ta' każijiet multipli żvelat tnaqqis sinifikanti ta' 16 % fir-riskju f'pazjenti kkurati b'zoledronic acid 4 mgf meta mqabbla ma' pazjenti fuq li kienu qed jirċievu pamidronate.
English: Replace with the following volume of sterile sodium chloride 9 mg/ml (0.9%), or 5% glucose solution for injection (ml)
Maltese: Issostitwixxi bilvolum li ġej ta' sodium chloride 9 mg/ml (0.9%) sterili, jew 5% glucose soluzzjoni għallinjezzjoni (ml)
English: 6.6 Special precautions for disposal and other handling Additional information on handling of Zoledronic acid medac 4 mg/100 ml solution for infusion, including guidance on the preparation of reduced doses using the Zoledronic acid medac ready-to-use bottle, is provided in section 4.2.
Maltese: Informazzjoni addizzjonali dwar l-immaniġġjar ta' Zoledronic acid medac 4 mg/100 ml soluzzjoni għall-infużjoni, li tinkludi gwida dwar il-preparazzjoni ta' dożi mnaqqsa bl-użu tal-flixkun lest biex jintuża ta' Zoledronic acid medac, hi pprovduta f'sezzjoni 4.2.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg of zoledronic acid (as monohydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Flixkun wieħed fih 4 mg ta' zoledronic acid (bħala monohydrate).
English: In clinical studies, zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Maltese: Fi studji kliniċi, zoledronic acid medac ingħata fl-istess ħin ma' mediċini li jintużaw b'mod komuni kontra l-kanċer, dijuretiċi, antibijotiċi u analġeżiċi, mingħajr ma seħħew interazzjonijiet kliniċi apparenti.
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' zoledronic acid fit-tfal minn età ta' sena sa 17-il sena għadhom ma ġewx determinati s'issa.
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 normali tal-kliewi, definita bħala CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml soluzzjoni għall-infużjoni m'għandux jiġi dilwit b'mod addizzjonali.
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: Il-marġini tas-sigurtà fir-rigward ta' effetti fuq il-kliewi kienu żgħar fl-istudji fit-tul dwar dożi ripeturi parenterali fl-annimali, imma l-livelli kumulattivi ta' mingħajr każijiet avversi (NOAELs) fi studji b'doża waħda (1.6 mg/kg) u studji b'dożi multipli li ngħataw għal sa xahar (0.06 - 0.6 mg/kg/kuljum) ma indikawx l-ebda effetti fil-kliewi f'dożi ekwivalenti għal, jew ogħla mill-ogħla doża terapewtika intenzjonata għall-bniedem.
English: Remove the volume of Zoledronic acid medac 4 mg/100 ml solution indicated from the bottle and replace with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% glucose.
Maltese: Neħħi l-volum ta' Zoledronic acid medac 4 mg/100 ml soluzzjoni indikat mill-flixkun u ssostitwih b'volum ugwali ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni sterili, jew 5% glucose.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid
Maltese: Zoledronic acid medac 4 mg/100 ml soluzzjoni għall-infużjoni
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' każijiet skelettriċi relatati (ksur patoloġiku, kompressjoni tas-sinsla, radjazzjoni jew operazzjoni fl-għadam, jew iperkalċemija kkawżata minn tumur) f'pazjenti adulti b'tumuri malinni avvanzati li jinvolvu l-għadam.
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Maltese: Indeboliment tal-kliewi Insuffiċjenza akuta tal-kliewi, ematurja, proteinurija
English: Cardiac disorders Common:
Maltese: Kodiċi ATC:
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 ta' zoledronic acid mill-kliewi ġiet korrelata mat-tneħħija tal-kreatinina, bit-tneħħija millkliewi li tirrappreżenta 75 ± 33 % tat-tneħħija tal-kreatinina, li wriet medja ta' 84 ± 29 ml/min (medda ta' 22 sa 143 ml/min) fl-64 pazjent bil-kanċer li ġew studjati.
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: L-ebda aġġustament fid-doża mhu meħtieġ f'pazjenti b'TIH li għandhom livell ta' kreatinina fis-serum ta' < 400 µmol/l jew < 4.5 mg/dl (ara sezzjoni 4.4).
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: Ir-reazzjonijiet avversi li ġejjin, elenkati f'Tabella 1, ġew akkumulati minn studji kliniċi u minn rapporti ta' wara t-tqegħid fis-suq wara kura li fil-parti l-kbira kienet kronika b'4 mg zoledronic acid:
English: While the risk is reduced with a dose of 4 mg zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Maltese: Filwaqt li r-riskju jitnaqqas b'doża ta' 4 mg ta' zoledronic acid mogħtija f'perjodu ta' 15-il minuta, id-deterjorament fil-funzjoni tal-kliewi xorta jista' jseħħ.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle with 100 ml solution contains 4 mg zoledronic acid (as monohydrate).
Maltese: U KWANTITATTIVA Flixkun wieħed b'100 ml ta' soluzzjoni fih 4 mg ta' zoledronic acid (bħala monohydrate).
English: In patients with mild to moderate renal impairment, reduced Zoledronic acid medac 4 mg/100 ml solution for infusion doses are recommended (see section “Posology” above and section 4.4).
Maltese: Hu rakkomandat li pazjenti b'indeboliment ħafif sa moderat tal-kliewi, jingħataw dożi mnaqqsa ta' Zoledronic acid medac 4 mg/100 ml soluzzjoni għall-infużjoni (ara sezzjoni “Pożoloġija” hawn fuq u sezzjoni 4.4).
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Maltese: Tabella 2: Riżultati tal-effikaċja (pazjenti b'kanċer tal-prostata li kienu qed jirċievu terapija ormonali)
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'osteogenesi imperfecta severa, zoledronic acid jidher li hu assoċjat ma' riskji iktar prominenti għal reazzjoni ta' fażi akuta, ipokalċemija u takikardija mhux spjegata, meta mqabbel ma' pamidronate, iżda din id-differenza naqset wara infużjonijiet sussegwenti.
English: Table 4: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Maltese: Tabella 4: Riżultati tal-effikaċja (tumuri solidi li ma kinux kanċer tas-sider jew tal-prostata)
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: Il-marġini tas-sigurtà fir-rigward ta' effetti fuq il-kliewi kienu żgħar fl-istudji fit-tul dwar dożi ripeturi parenterali fl-annimali, imma l-livelli kumulattivi ta' mingħajr każijiet avversi (NOAELs) fi studji b'doża waħda (1.6 mg/kg) u studji b'dożi multipli li ngħataw għal sa xahar (0.06-0.6 mg/kg/kuljum) ma indikawx l-ebda effetti fil-kliewi f'dożi ekwivalenti għal, jew ogħla mill-ogħla doża terapewtika intenzjonata għall-bniedem.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zoledronic acid medac (see section 4.4).
Maltese: Każijiet ta' osteonekrosi tax-xedaq ġew irrappurtati, l-aktar f'pazjenti bil-kanċer ikkurati bi prodotti mediċinali li jinibixxu l-assorbiment mill-ġdid, bħal Zoledronic acid medac (ara sezzjoni 4.4).
English: A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Maltese: Eżami dentali b'dentistrija preventiva adattata u evalwazjoni tal-benefiċċju-riskju huma rakkomandati qabel il-kura b'bisfosfonati f'pazjenti b'fatturi ta' riskju fl-istess ħin.
English: How to store Zoledronic acid medac
Maltese: Mediċini oħra u Zoledronic acid medac
English: ≥ 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, in-nuqqas ta' dejta klinika dwar is-sigurtà f'pazjenti b'indeboliment sever tal-kliewi (fil-provi kliniċi definit 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 tal-għadam, rispettivament) fil-linja bażi, u minħabba dejta farmakokinetika limitata f'pazjenti b'indeboliment sever fil-funzjoni tal-kliewi fil-linja bażi (tneħħija tal-kreatinina ta' < 30 ml/min), l-użu ta' Zoledronic acid medac mhuwiex irrakkomandat f'pazjenti b'indeboliment sever fil-funzjoni tal-kliewi.
English: This resulted in exaggerated pharmacological effects considered to be related to the compound's inhibition of skeletal calcium metabolisation, resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Maltese: Dan irriżulta f'effetti farmakoloġiċi esaġerati li huma kkunsidrati li huma relatati mal-inibizzjoni tal-kompost tal-metabolizzazzjoni tal-calcium fl-iskeletru, li tirriżulta f'ipokalċemija ta' firen li jkunu waslu biex iwelldu, effett tal-klassi tal-bisfosfonati, distoċija u waqfien bikri tal-istudju.
English: - High blood pressure, shortness of breath, dizziness, sleep disturbances, taste disturbances,
Maltese: − Pressjoni għolja, qtugħ ta' nifs, sturdament, disturbi fl-irqad, disturbi fit-togħma, tregħid,
English: Table 3: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Maltese: Tabella 3: Riżultati tal-effikaċja (pazjenti b'kanċer tal-prostata li kienu qed jirċievu terapija ormonali)
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Maltese: Tabella 4: Riżultati tal-effikaċja (pazjenti b'kanċer fis-sider u b'majeloma multipla)
English: The active substance in Zoledronic acid medac is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Maltese: Is-sustanza attiva f'Zoledronic acid medac hi zoledronic acid, li jappartjeni għal grupp ta' sustanzi li jissejħu bisfosfonati.
English: The cases from safety database did report multiple risk factors including underlying malignancy, bone metastases; concomitant therapy with steroids, angiogenesis inhibitors, radiotherapy but the exact underlying cause for the osteonecrosis was not ascertained.
Maltese: Il-każijiet mid-dejtabażi tas-sigurtà irrappurtaw fatturi ta' riskju multipli inklużi tumuri malinni sottostanti, metastasi fl-għadam; terapija konkomitanti bi sterojdi, inibituri talanġjoġenesi, radjuterapija, iżda l-kawża prinċipali eżatta għall-osteonekrożi ma kinitx aċċertata.
English: Fewer zoledronic acid 4 mg patients suffered pathological fractures.
Maltese: Inqas pazjenti fuq zoledronic acid 4 mg sofrew ksur patoloġiku.
English: Fracture adverse events of long bones in the lower extremities were reported in approximately 24 % (femur) and 14 % (tibia) of zoledronic acid-treated patients versus 12 % and 5 % of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43 % (32/74) versus 41 % (31/76).
Maltese: Każijiet avversi ta' ksur fl-għadam it-twil tar-riġlejn ġew irrappurtati f'madwar 24 % (wirk) u 14 % (qasba tas-sieq) ta' pazjenti kkurati b'zoledronic acid kontra 12 % u 5 % ta' pazjenti kkurati b'pamidronate li kellhom osteoġenesi imperfecta severa, kien x'kien it-tip tal-marda u l-kawżalità, iżda l-inċidenza globali ta' ksur kienet komparabbli għall-pazjenti kkurati b'zoledronic acid u pamidronate:
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-bqija tkun fil-biċċa l-kbira tagħha mwaħħla mat-tessut tal-għadam.
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: Ir-reazzjonijiet avversi li ġejjin, elenkati f'Tabella 2, ġew akkumulati minn studji kliniċi u minn rapporti ta' wara t-tqegħid fis-suq wara kura li fil-parti l-kbira kienet kronika b'4 mg zoledronic acid:
English: Nausea, vomiting, decreased appetite Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Maltese: Tqallih, rimettar, telf ta' aptit Dijarea, stitikezza, uġigħ addominali, dispepsja, stomatite, ħalq xott
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 ta' zoledronic acid mill-kliewi ġiet ikkorrelata mat-tneħħija tal-kreatinina, bit-tneħħija millkliewi li tirrappreżenta 75 ± 33 % tat-tneħħija tal-kreatinina, li wriet medja ta' 84 ± 29 ml/min (medda ta' 22 sa 143 ml/min) fl-64 pazjent bil-kanċer li ġew studjati.
English: Solution for infusion.
Maltese: fosfru u manjesju).
English: Plastic vial made of clear, colourless cycloolefine copolymer with Type I bromobutyl rubber stopper and sealed with aluminium polypropylene flip-off seal.
Maltese: Kunjett tal-plastik magħmul minn cycloolefine copolymer ċar u bla kulur, b'tapp tal-lastku talbromobutyl ta' Tip I u ssiġillat b'siġill tat-tip li jinqala' bis-saba' tal-aluminju polypropylene.
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 medac.
Maltese: − Jekk qed tiġi kkurat biex jitnaqqas l-ammont ta' calcium fid-demm tiegħek, normalment se tingħata infużjoni waħda biss ta' Zoledronic acid medac.
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 tal-mediċina tikkonsisti f'diversi sintomi li jinkludu deni, mijalġja, uġigħ ta' ras, uġigħ fl-estremitajiet, tqalligħ, rimettar, dijarea, altralġja u artrite b'nefħa sussegwenti fil-ġogi.
English: Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Maltese: Zoledronic acid ma jiġix immetabolizzat u jiġi eliminat mhux mibdul mill-kliewi.
English: It is especially important that you tell your doctor if you are also taking: - 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 għal kura ta' infezzjonijiet severi), calcitonin (tip ta' mediċina użata biex tikkura l-osteoporożi wara l-menopawsa u iperkalċimija), dijuretiċi loop (tip ta' mediċina biex tikkura pressjoni għolja jew edima) jew mediċini oħra li jbaxxu l-kalċju, għax il-kombinazzjoni ta' dawn ma' bisfosfonati tista' tikkawża li l-livell tal- kalċju fid-demm jitbaxxa żżejjed.
English: Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
Maltese: Għalkemm ma ġiet osservata l-ebda teratoġeniċità u fetotossiċità fil-fniek, instabet tossiċità materna.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One bottle contains 4 mg of zoledronic acid (as monohydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 4 mg ta' zoledronic acid (bħala monohydrate).
English: Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Maltese: Riżultati tal-provi kliniċi fil-kura ta' osteoġenesi imperfecta severa f'pazjenti pedjatriċi li kellhom minn sena sa 17-il sena
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Maltese: Ir-riżultati wrew li zoledronic acid 4 mg wera effikaċja komparabbli ma' 90 mg pamidronate fil-prevenżjoni ta' SREs.
English: Remove the volume of Zoledronic acid medac solution indicated from the bottle and replace with an equal volume of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, or 5% w/v glucose solution for injection.
Maltese: Neħħi l-volum ta' Zoledronic acid medac soluzzjoni indikat mill-flixkun u ssostitwih b'volum ugwali ta' soluzzjoni għall-injezzjoni sterili ta' 9 mg/ml (0.9%) sodium chloride, jew 5% glucose soluzzjoni għall-injezzjoni.
English: • The readily prepared Zoledronic acid medac infusion solution should preferably be used immediately.
Maltese: • Is-soluzzjoni għall-infużjoni ppreparata lesta ta' Zoledronic acid medac għandha preferibbilment tintuża immedjatament.