FrancophonIA/ELRC3.0 huggingface dataset:
English: Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Maltese: Influwenza, infezzjonijiet fin-naħa ta' fuq tal-apparat tan-nifs, tnaqqis fl-għadd taċ-ċelluli ħomor, telf ta' aptit, nuqqas ta' rqad, xejra ta' ngħas li tista' tinkludi li tkun anqas żvelt u konxju ta' x'qed jiġri, sensazzjoni ta' tnemnim jew titrix, għeja estrema, tregħid, tintilef minn sensik temporanjament, infezzjoni jew irritazzjoni jew infjammazzjoni fl-għajn bl-uġigħ u l-ħmura, tħoss kollox idur bik, żieda fil-pressjoni fid-demm, fwawar, sogħla, qtugħ ta' nifs, stonku mqalleb, uġigħ fl-addome, stitikezza, ħalq xott, ħruq ta' stonku, raxx fil-ġilda, għaraq żejjed, ħakk, ħmura fil-ġilda, uġigħ fl-għonq, ebusija fil-muskoli, fl-għadam u/jew fil-ġogi, nefħa fil-ġogi, spażmi fil-muskoli, uġigħ fl-ispalla, uġigħ filmuskoli ta' sidrek jew fil-qafas ta' sidrek, infjammazzjoni fil-ġogi, dgħjufija fil-muskoli, riżultati tattestijiet tal-kliewi mhux normali, tgħaddi l-awrina b'mod frekwenti mhux normali, nefħa tal-idejn, lgħekiesi jew is-saqajn, għatx, uġigħ tas-snien, tibdil fis-sens tat-togħma.
English: 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, ipokalċimja, fibrillazzjoni tal-atrija, anafilassi, marda tal-interstizju tal-pulmun.
English: The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Maltese: L-effetti ta' zoledronic acid mogħti ġol-vina fil-kura ta' pazjenti pedjatriċi (mill-età ta' sena sa 17-il sena) b'osteoġenesi imperfecta severa (tipi I,III u IV) tqabblu ma' pamidronate mogħti ġol-vina fi studju wieħed internazzjonali, multiċentriku, b'individwi magħżula b'mod każwali, open label b'74 u 76 pazjent f'kull grupp ta' kura, rispettivament.
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
Maltese: Tabella 6: Reazzjonijiet avversi osservati f'pazjenti pedjatriċi b'osteoġenesi imperfecta severa1
English: Renal impairment has been observed following the administration of zoledronic acid (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after zoledronic acid administration.
Maltese: Ġie osservat indeboliment renali wara li ngħata zoledronic acid (ara sezzjoni 4.8), speċjalment f'pazjenti li diġà kellhom disfunzjoni renali u riskji oħra li jinkludu età avvanzata, prodotti mediċinali konkomitanti nefrotossiċi, terapija dijuretika konkomitanti (ara sezzjoni 4.5), jew deidrazzjoni li sseħħ wara l-għoti ta' zoledronic acid.
English: Zoledronic acid 4 mg (N=86)
Maltese: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104)
English: •Breast-feeding (see section 4.6).
Maltese: - Treddigħ (ara sezzjoni 4.6)
English: Tachycardia Respiratory, thoracic and mediastinal disorders Common:
Maltese: Takikardija Disturbi respiratorji, toraċiċi u medjastinali Komuni:
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: Adverse reactions are ranked under headings of frequency, the most frequent first, 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: Ir-reazzjonijiet avversi qegħdin imqassmin taħt it-titlu tal-frekwenza, l-aktar frekwenti l-ewwel, bil-konvenzjoni: 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: - Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva, għal bisphosphonates oħra jew għal kwalunkwe wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1
English: Zoledronic Acid Hospira 4 mg/5 ml sterile concentrate IV
Maltese: Zoledronic Acid Hospira 4 mg/5 ml konċentrat sterili
English: One vial contains 4 mg of zoledronic acid.
Maltese: Kull pakkett fih 4 mg zoledronic acid.
English: Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less than 2.10 mmol/l) occurred in 2.3% of zoledronic acid-treated patients in a large clinical trial compared to 21% of zoledronic acid-treated patients in the Paget's disease trials.
Maltese: Minn stima tal-laboratorju, livelli temporanji ta' kalċju taħt il-livelli tal-medda ta' referenza normali mingħajr sintomi (anqas minn 2.10 mmol/l) seħħew f'2.3% tal-pazjenti kkurati b'zoledronic acid fi prova klinika kbira meta mqabbla ma' 21% tal-pazjenti kkurati b'zoledronic acid fil-provi bil-marda ta' Paget.
English: The adverse reactions ranked under headings of frequency, are presented in Table 6.
Maltese: Ir-reazzjonijiet avversi kklassifikati taħt ittitli ta' frekwenza, huma elenkati f'Tabella 6.
English: In Phase I dose
Maltese: DATA TA' SKADENZA
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip Renal and urinary disorders Common:
Maltese: Osteonekrożi tal-kanal estern tas-smigħ (reazzjoni avversa għall-klassi bifosfonati) u ta' siti anatomiċi oħra inklużi l-wirk u l-ġenbejn Disturbi fil-kliewi u fis-sistema urinarja Komuni:
English: Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of medicinal product with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Maltese: Żidiet żgħar fl-AUC(0-24hr), b'madwar 30% sa 40% fl-indeboliment tal-kliewi ħafif għal moderat, imqabbel ma' pazjent b'funzjoni renali normali, u nuqqas ta' akkumulu tal-prodott mediċinali b'dożi multipli irrispettivament mill-funzjoni renali, jissuġġerixxu li tibdil fid-dożi ta' zoledronic acid f'pazjenti li għandhom indeboliment renali ħafif (Clcr = 50-80 ml/min) u moderat sakemm it-tneħħija tal-kreatinina tinżel għal 35 ml/min mhux neċessarju.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Maltese: It-tneħħija totali mill-ġisem hija ta' 5.04 ± 2.5 l/h, indipendenti mid-doża, u mhix affettwata minn sess, età, razza u piż tal-ġisem.
English: Limited data on re-treatment of Paget's disease are available (see section 5.1).
Maltese: Teżisti informazzjoni limitata dwar trattament millġdid tal-marda ta' Paget (ara sezzjoni 5.1).
English: Uncommon: Thrombocytopenia, leukopenia Rare:
Maltese: Thromboċitopenja, lewkopenja
English: − Low level of magnesium and potassium in the blood.
Maltese: - Livell baxx ta' magnesium u potassium fid-demm.
English: The following precautions should be taken into account to minimise the risk of renal adverse reactions:
Maltese: Il-prekawzjonijiet li ġejjin għandhom jiġu kkunsidrati sabiex jiminimizzaw ir-riskju ta' reazzjonijiet renali avversi:
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Maltese: L-ipokalċimija hija riskju identifikat importanti b'zoledronic acid fl-indikazzjonijiet approvati.
English: Abdominal pain Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi Komuni:
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Maltese: It-tneħħija totali mill-ġisem hija 5.04 ± 2.5 l/h, indipendenti mid-doża, u mhux affettwat mis-sess, età, razza jew piż tal-ġisem.
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 ingħata flimkien ma' mediċini li jintużaw ta' spiss kontra l-kanċer, dijuretiċi, antibijotiċi u analġeżiċi, mingħajr ma kien hemm interazzjonijiet li kienu klinikament evidenti.
English: − Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
Maltese: - Fi studji li saru fuq il-boroż tal-polyvinylchloride, polyethylene u polypropylene ma deherx li kien hemm xi inkompatibbiltà b'zoledronic acid.
English: Zoledronic Acid Hospira can be given to people aged 65 years and over.
Maltese: Zoledronic Acid Hospira jista' jingħata lill-persuni li għandhom 65 sena jew aktar.
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
Maltese: Fl-istudju HORIZON - Prova Pivitali tal-Ksur [PFT] (ara sezzjoni 5.1), l-inċidenza globali tal-fibrillazzjoni atrijali kienet 2.5% (96 minn 3,862) u 1.9% (75 minn 3,852) f'pazjenti li kienu qed jirċievu zoledronic acid u plaċebo, rispettivament.
English: Hypophosphataemia
Maltese: Ipofosfatimija
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 (definit 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: For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
Maltese: Għall-każijiet serji ta' fibrillazzjoni flatrija miġbura flimkien il-każijiet kienu 1.3% għal zoledronic acid u 0.8% għal plaċebo.
English: Proportion of patients with SREs (%) p-value Median time to SRE (days)
Maltese: Proporzjon ta' pazjenti b'SREs (%) Valur-p
English: Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent.
Maltese: Infużjoni waħda jew multipla ta' 5 u 15-il minuta ta' 2, 4, 8 u 16 mg zoledronic acid f'64 pazjent taw it-tagħrif farmakokinetiku li ġej, li nstab li kien marbut mad-doża.
English: Before receiving Zoledronic Acid Hospira, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
Maltese: Qabel ma tingħata trattament b'Zoledronic Acid Hospira, għid lit-tabib, lill-ispiżjar jew lill-infermiera tiegħek jekk - ikollok xi problemi b'ħalqek jew snienek, bħal nuqqas ta' saħħa fis-snien, mard fil-ħanek jew jekk tkun qed tippjana li taqla' xi snien; - ma tmurx għal kura dentali ta' rutina jew ilek żmien twil ma tmur għal check-up tas-snien; - tpejjep (minħabba li dan jista' jżid ir-riskju ta' problemi fis-snien); - preċedentement tkun ingħatajt trattament b'bisphosphonate (użat biex jikkura jew jipprevjeni disturbi fl-għadam); - qed tieħu mediċini msejħa kortikosterojdi (bħal prednisolone jew dexamethasone) - għandek kanċer.
English: Zoledronic Acid Hospira, 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 Hospira, iddilwit aktar f'100 ml (ara sezzjoni 6.6), għandu jingħata bħala infużjoni waħda ġol-vini għal mhux inqas minn 15-il minuta.
English: In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were reported (0.7%) following the administration of zoledronic acid.
Maltese: Fi prova klinika kbira, reazzjonijiet lokali fis-sit mnejn ingħatat l-infużjoni, bħal ħmura, nefħa u/jew uġigħ, kienu rrappurtati (0.7%) wara l-għotja ta' zoledronic acid.
English: Zoledronic acid has been associated with reports of renal dysfunction.
Maltese: Zoledronic acid ġie assoċjat ma' rapporti ta' nuqqas ta' funzjoni renali.
English: 100 ml polypropylene bags with a polypropylene twist-off port fitted with a cap, with a polyester/polypropylene overwrap
Maltese: Boroż tal-polypropylene ta' 100 ml b'port li jintlewa tal-polypropylene ffittjat b'gatu b'inforra ta' barra tal-polyester/polypropylene
English: Additional information on handling of Zoledronic Acid Hospira, including guidance on preparation of reduced doses, is provided in section 4.2.
Maltese: Informazzjoni addizzjonali dwar il-ġestjoni ta' Zoledronic Acid Hospira, li tinkludi gwida dwar il-preparazzjoni ta' dożi mnaqqsa, hija pprovduta fis-sezzjoni 4.2.
English: In a pooled analysis of safety data from trials for the use of zoledronic acid 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' diversi analiżi dwar is-sigurtà waqt il-provi ta' reġistrazzjoni ta' zoledronic acid għall-prevenzjoni ta' problemi skeletriċi f'pazjenti li għandhom kanċer avvanzat 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: majeloma multipla (3.2 %), kanċer tal-prostata (3.1 %), kanċer tas-sider (4.3 %), tumuri tal-pulmun u tumuri solidi oħrajn (3.2 %).
English: Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Maltese: Peress li zoledronic acid ma jiġix immetabolizzat mill-bnedmin u s-sustanza nstabet li kellha ftit jew l-ebda ħila bħala impeditur tal-enzimi P450 li jaħdem b'mod dirett u/jew b'mod irriversibbli dipendenti fuq il-metaboliżmu, mhux probabbli li zoledronic acid jnaqqas it-tneħħija ta' sustanzi li jiġu mmetabolizzati permezz tas-sistemi ta' enzimi ta' cytochrome P450.
English: Zoledronic Acid Hospira is contraindicated during pregnancy (see section 4.3).
Maltese: Zelodronic Acid Hospira hu kontraindikat matul it-treddigħ (ara sezzjoni 4.3).
English: Τηλ.
Maltese: Deni.
English: Median time to relapse (re-increase of albumin-corrected serum calcium 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Maltese: Iż--żmien medjan biex jerġa' jogħla (livell ta' kaljċu fis-serum ikkoreġut għall-albumina reġa' tela' għal  2.9 mmol/l) kien ta' 30 sa 40 ġurnata għall-pazjenti fuq kura b'zoledronic acid kontra 17-il ġurnata f'pazjenti li kienu fuq pamidronate 90 mg (valuri-p: 0.001 għal 4 mg u 0.007 għal 8 mg zoledronic acid).
English: Common (may affect up to 1 in 10 people):− Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Maltese: Komuni (li jista' jaffettwa sa persuna 1 f'10): - 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: − Hypersensitivity reactions.
Maltese: Reazzjoni ta' sensittività eċċessiva
English: Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) Flu-like symptoms including arthritis and joint swelling.
Maltese: - Mard interstizzjali tal-pulmun (infjammazzjoni tat-tessut madwar il-boroż tal-arja fil-pulmun) - Sintomi jixbhu lill-influwenza inkluż artrite u nefħa fil-ġogi.
English: Concentrate for solution for infusion 4 mg/5 ml
Maltese: Konċentrat għal soluzzjoni għall-injezzjoni 4 mg/5 ml
English: − The other ingredients are: mannitol, sodium citrate, sodium chloride and water for injections.
Maltese: - Is-sustanzi l-oħra huma: mannitol, sodium citrate, sodium chloride u ilma għal injezzjonijiet.
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 apprezzabli 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 ta' interazzjoni.
English: Uncommon: Blurred vision, scleritis and orbital inflammation Rare
Maltese: Vista mċajpra, sklerite u infjammazzjoni orbitali
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Maltese: Fi prova waħda kkontrollata, double-blind u magħmula b'mod każwali fuq 3 snin li evalwat l-effikaċja u s-sigurtà ta' 5 mg ta' zoledronic acid darba fis-sena mqabbel ma' plaċebo fil-kura tal-osteoporożi ta' wara l-menopawża (PMO), l-inċidenza globali ta' fibrillazzjoni tal-atrija kienet ta' 2.5% (96 minn 3,862) u 1.9% (75 minn 3,852) f'pazjenti li kienu qegħdin jingħataw 5 mg ta' zoledronic acid u plaċebo, rispettivament.
English: There was a transient increase in serum creatinine observed within 10 days in 1.8% of zoledronic acid-treated patients versus 0.8% of placebo-treated patients.
Maltese: Kien hemm żieda momentanja tal-kreatinina fis-serum fi żmien 10 ijiem f'1.8% tal-pazjenti kkurati b'zoledronic acid kontra 0.8% tal-pazjenti kkurati bi plaċebo.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Maltese: Prodotti mediċinali għall-kura ta' mard tal-għadam, bisphosphonates, Kodiċi ATC:
English: Clinical experience with acute overdose of zoledronic acid is limited.
Maltese: L-esperjenza klinika b'doża eċċessiva akuta ta' zoledronic acid hija limitata.
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: 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 sorveljati bir-reqqa peress li deher indeboliment tal-funzjoni renali (li jinkludi insuffiċjenza renali) u anormalitajiet tal-elettroliti fis-serum (li jinkludu tal-calcium, phosphorus u magnesium).
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Maltese: Tabella 4: Riżultati ta' effikaċja (pazjenti b'kanċer fis-sider jew b'majeloma multipla) Kwalunkwe SRE (+TIH)
English: In the intravenous bolus studies, the doses that were well-tolerated decreased with increasing study duration: 0.2 and 0.02 mg/kg daily was well tolerated for 4 weeks in rats and dogs, respectively but only 0.01 mg/kg and 0.005 mg/kg in rats and dogs, respectively, when given for 52 weeks.
Maltese: Fi studji ta' bolus mogħti ġol-vina, id-dożi li kienu ttollerati sew naqsu aktar ma twal l-istudju: 0.2 u 0.02 mg/kg kuljum kienu ttollerati sew għal 4 ġimgħat f'firien u klieb, rispettivament iżda 0.01 mg/kg u 0.005 mg/kg biss f'firien u klieb, rispettivament, meta jingħata għal 52 ġimgħa.
English: Uncommon: Acute renal failure, haematuria, proteinuria Rare
Maltese: Insuffiċjenza renali, ematurja, proteinurja
English: Low levels of phosphate in the blood.
Maltese: Livelli baxxi ta' phosphate fid-demm.
English: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Maltese: Pfizer Luxembourg SARL filialas Lietuvoje Tel.
English: Monitoring test
Maltese: Test ta' monitoraġġ
English: Hypocalcaemia
Maltese: Ipokalċemija
English: For storage conditions of the diluted solution for infusion, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara d-dilwizzjoni tas-soluzzjoni għall-infużjoni, ara sezzjoni 6.3.
English: Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Maltese: Il-pazjenti għandhom jingħataw ukoll suppliment mill-ħalq ta' 500 mg calcium u 400 IU vitamina D kuljum.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Komuni (li jaffettwa minn utent 1 sa 10 f'100)::
English: In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 1.87 mmol/l) following zoledronic acid administration.
Maltese: Fi provi kliniċi dwar l-osteoporożi, madwar 0.2% tal-pazjenti kellhom tnaqqis notevoli fil-livelli tal-kalċju fis-serum (anqas minn 1.87 mmol/l) wara li ngħataw zoledronic acid.
English: To avoid potential incompatibilities, Zoledronic Acid Hospira is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibbiltajiet potenzjali, Zoledronic Acid Hospira għandu jiġi dilwita b'9 mg/ml (0.9%) ta' soluzzjoni ta' sodium chloride jew b'5% w/v soluzzjoni ta' glucose għallinjezzjonijiet.