FrancophonIA/ELRC3.0 huggingface dataset:
English: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Maltese: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *Valur-p mqabbel ma' pamidronate
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 09 Desember 2016
Maltese: Data tal-aħħar tiġdid: 09 ta' Diċembru 2016
English: 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Maltese: 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Id-dożi ġew ikkalkulati billi qieset mira ta' AUC ta' 0.66 (mg•hr/l) (CLcr = 75 ml/min).
English: Pack sizes: 1, 4 or 10 vials.
Maltese: Qisien tal-pakketti: 1, 4 jew 10 kunjetti.
English: Thrombocytopenia, leukopenia
Maltese: Tromboċitopenija, lewkopenja
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Maltese: Tabella 6: Reazzjonijiet avversi osservati f'pazjenti pedjatriċi b'osteoġenesi imperfecta severa1
English: Baseline Creatinine Clearance (ml/min)
Maltese: Tneħħija tal-kreatinina mal-linja bażi (ml/min)
English: - Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Maltese: - Terapiji konkomitanti: kimoterapija, inibituri tal-anġjoġenesi (ara sezzjoni 4.5), radjoterapija flgħonq u r-ras, kortikosterojdi.
English: Blurred vision, scleritis and orbital inflammation Uveitis
Maltese: Vista mċajpra, skleritie u infjammazzjoni orbitali
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 naqqas ir riskju ta' SRE's b'41% f'analiżi ta' ħafna avveniment (proporzjon tar-riskju=0.59, p=0.019) meta mqabbel mal-plaċebo.
English: MM/YYYY
Maltese: MM MM
English: The plasma protein binding is low, with the unbound fraction ranging from 60% at 2 ng/ml to 77% at 2000 ng/ml of zoledronic acid.
Maltese: Il-proteina fil-plażma huwa baxx, bl-frazzjoni mhux marbuta li jvarjaw minn 60% sa 2 ng/ml sa 77% fuq 2000 ng/ml ta' zoledronic acid.
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 vs 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) vs 41% (31/76).
Maltese: Każijiet avversi ta' ksur fl-għadam twil tar-riġel kienu rrappurtati f'madwar 24% (femur) u 14% (tibia) ta' pazjenti li kellhom osteoġenesi imperfetta severa kkurati b'zoledronic acid kontra 12% u 5% ta' pazjenti kkurati b'pamidronate, kienet x'kienet it-tip tal-marda u l-kawża tagħha iżda l-inċidenza globali ta' ksur kienet kumparabbli mal-pazjenti kkurati b'zoledronic acid u pamidronate: 43% (32/74) kontra 41% (31/76).
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Maltese: Konvulzjonijiet, ipoestesija u tetanja (kawża ta' ipokalċimija)
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva, għal bisfosfonati oħra jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Maltese: Ir-rata ta' SRE (każijiet/sena persuna) kienet 0.628 għal zoledronic acid u ta' 1.096 għall-plaċebo.
English: Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Maltese: Osteonekrożi tax-kanal awditorju estern (reazzjoni avversa relatata mal-klassi tal bisfosfonati) u ta' siti anatomiċi oħra inklużi l wirk u l-ġenbejn
English: While being treated with Zoledronic acid Actavis, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Maltese: Waqt li tkun qed tiġi ikkurat b'Zoledronic acid Actavis, inti għandek iżżomm l-iġjene orali tajba (inkluż li taħsel snienek regolari) u jkollok rutina ta' appuntamenti rutina dentali.
English: Risk reduction of suffering from multiple events**
Maltese: Tnaqqis ta' riskju li wieħed jiżviluppa ħafna avvenimenti f'daqqa** (%)
English: Placebo Zoledronic acid
Maltese: Δ Plaċebo  Zoledronic acid
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 micromol/l or > 3.0 mg/dl were excluded.
Maltese: Fi provi kliniċi b'Zoledronic acid Actavis, pazjenti b'kreatinina fis-serum ta' >265micromol/l jew >3.0 mg/dl kienu esklużi.
English: - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Maltese: - Kanċer, kundizzjonijiet diġà eżistenti li jaffettwaw lill-pazjent (e.ż. anemija, mard tal koagulazzjoni, infezzjoni), it-tipjip.
English: - The active substance is zoledronic acid.
Maltese: - Is-sustanza attiva ta' Zoledronic acid Actavis hi zoledronic acid.
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: Ġiet użata l-klassifika 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
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Maltese: CLcr tiġi kkalkulata mill-krejatinina fis-serum bil-formula Cockcroft
English: Zoledronic acid, used as indicated in sections 4.1 and 4.2, has been associated with reports of renal dysfunction.
Maltese: Zoledronic acid Actavis, użat bħalma hu indikat f' sezzjonijiet 4.1 u 4.2, ġie assoċjat ma' rapporti ta' nuqqas ta' funzjoni renali.
English: Zoledronic acid Actavis is contraindicated in breast-feeding women (see section 4.3).
Maltese: Zoledronic acid Actavis huwa kontra-indikat f'nisa li qed ireddgħu (ara sezzjoni 4.3).
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: il sena) b'osteoġenesi imperfecta severa (tipi I,III u IV) tqabblu ma' pamidronate mogħti ġol-vina fi studju wieħed internazzjonali, multiċentriku, randomizzat, open label b'74 u 76 pazjent f'kull grupp ta' kura, rispettivament.
English: Additional information on handling of Zoledronic acid Actavis, including guidance on preparation of reduced doses, is provided in section 4.2.
Maltese: Informazzjoni addizzjonali dwar l-immaniġġjar ta' Zoledronic acid Actavis, inkluż gwida dwar il preparazzjoni ta' dożi mnaqqsa hija pprovduta fis-sezzjoni 4.2.
English: For storage conditions of Zoledronic acid Actavis after dilution, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna ta' Zoledronic acid Actavis wara rikostitwizzjoni, ara sezzjoni 6.3.
English: - A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Maltese: Fanconi (normalment tiġi determinata mit-tabib tiegħek permezz ta' ċerti testijiet tal-awrina) .
English: Zoledronic acid Actavis can be given to people aged 65 years and over.
Maltese: Zoledronic acid Actavis jista' jingħata lill-persuni li għandhom 65 sena jew aktar.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Maltese: Zoledronic acid mogħti ġol-vina jiġi eliminat mill-ġisem bi proċess li fih tliet fażijiet: proċess mgħaġġel b'żewġ fażijiet li jneħħi l-mediċina miċ-ċirkolazzjoni sistemika, b'half-lives ta' t½α0.24 u t½β 1.87 sigħat, segwit minn fażi ta' eliminazzjoni twila b'half-life ta' eliminazzjoni terminali ta' t½γ
English: In the clinical studies, patients with serum creatinine > 400 micromol/l or > 4.5 mg/dl were excluded.
Maltese: Fl-istudji kliniċi, pazjenti li kellhom krejatinina fis-serum ta' >400 micromol/l jew >4.5 mg/dl kienu esklużi.
English: Zoledronic acid Actavis contains sodium
Maltese: Zoledronic acid Actavis fih sodium
English: In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5000 ng/ml.
Maltese: Fi studju in vitro, zoledronic acid ma wera affinità baxxa għall-komponenti ċellulari tad-demm uman, bil-demm medja għal proporzjon tal-konċentrazzjoni fil-plażma ta' 0.59 fil-medda ta' konċentrazzjoni ta' 30 ng/ml sa 5000 ng/ml.
English: After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
Maltese: L-istabbilta' kimika u fiżika waqt l-użu ġiet murija għal 24 siegħa f' 2˚C - 8˚C u f' 25 ° C wara li jitħallat ma' 100 ml ta' 0.9% w/v soluzzjoni ta sodium chloride jew 100 ml 5% w/v glucose.
English: In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 micromol/l), an increase of 0.5 mg/dl or 44 micromol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 micromol/l), an increase of
Maltese: - Għall-pazjenti b'linja bażi anormali ta' kreatinina (>1.4 mg/dl jew >124 micromol/l), żieda ta'
English: - The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Maltese: - Is-soluzzjoni ta' zoledronic acid tingħata ta' darba bħala infużjoni ġol-vini fuq medda ta' 15-il minuta, f'pajp separat għall-infużjoni.
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Maltese: − Reazzjonijiet ta' sensittività eċċessiva.
English: One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Maltese: Millilitru 1 tal-konċentrat fih 0.8 mg zoledronic acid (bħala monohydrate).
English: - The other ingredients are: mannitol, sodium citrate and water for injections.
Maltese: - Is-sustanzi l-oħra huma : mannitol, sodium citrate, ilma għall-injezzjonijiet.
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 ma' leffetti 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: 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 leffett farmaċewtiku tal-prodott.
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 li jispikkaw l-aktar bħala reazzjonijiet tal-fażi akuta, ipoklaċimija u takikardija mingħajr spjegazzjoni, meta mqabbel ma' pamidronate, iżda din id-differenza naqset wara infużjonijiet sussegwenti.
English: In clinical studies, zoledronic acid, used as indicated in sections 4.1 and 4.2, has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Maltese: Fi studji kliniċi, zoledronic acid, użat bħalma hu indikat f' sezzjonijiet 4.1 u 4.2, ngħata flimkien ma' mediċini li jintużaw ta' spiss kontra l-kanċer, dijuretiċi, antibijotiċi u analġeżiċi, mingħajr ma kien hemm interazzjonijiet li kienu klinikament evidenti.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) kull doża, jiġifieri essenzjalment "bla sodium".
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: - Potenza tal-bisfosfonat (riskju ogħla għal komposti potenti ħafna), mnejn jingħata (riskju ogħla għal għoti parenterali) u doża kumulattiva ta' bisfosfonat.
English: Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Maltese: zoledronic acid huwa kkaratterizzat minn tnaqqis ta' kalċju fis-serum u tnaqqis fl-eskrezzjoni urinarja ta' kalċju.
English: Zoledronic acid Actavis 4 mg/5 ml sterile concentrate zoledronic acid
Maltese: Zoledronic acid Actavis 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni zoledronic acid
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-kalċju fid-demm (livell ta' kalċjufis-serum korrett għall-albumina ≥12.0 mg/dl jew 3.0 mmol/l) hija doża singola ta' 4 mg zoledronic acid.
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 talBrief Pain Inventory, BPI) deher mar-4 ġimgħat u ma' kull punt sussegwenti waqt l-istudju, meta mqabbel mal-plaċebo (Figura 1).
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia)
Maltese: Bradikardija, arritmija tal-qalb (kawża ta'
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Maltese: Sturdament, parasteżija, disgewżja , ipoesteżija, iperesteżija, tregħid, ħedla ta' ngħas
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, ansjetà, disturb fl-irqad, disturbi fit-togħma, tregħid,
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: 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 micromol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 micromol/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 Actavis is not recommended in patients with severe renal impairment.
Maltese: ≥265 micromol/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 Actavis f'pazjenti b'indeboliment sever fil-funzjoni tal-kliewi mhux irrakkomandat.
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Maltese: F'pazjenti b'indeboliment renali ħafif sa moderat, huma rrakkomandati dożi mnaqqsa ta' Zoledronic acid Actavis (ara s-sezzjoni “Pożoloġija” hawn fuq u s-sezzjoni 4,4).
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: (ara sezzjoni 4.2) għandhom jiġu mgħassa bir-reqqa peress li dehru indeboliment tal-funzjoni renali (inkluża insuffiċjenza renali) u anormalitajiet tal-elettroliti fis-serum (inklużi kalċju, fosfru u manjesju).
English: Table 5: Proportion of complete responders by day in the combined TIH studies Day 4
Maltese: Tabella 5: Proporzjon ta' pazjenti li rrispondew kompletament għall-kura skond il-ġurnata fl-istudji kkombinati ta' TIH
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Maltese: Fertilità Zoledronic acid ġie evalwat fil-firien għall-possibbiltà ta' effetti mhux mixtieqa fuq il-fertilità tal ġenerazzjoni parentali u ta' F1.
English: The multiple event analysis revealed a significant risk reduction of 16% in patients treated with 4 mg zoledronic acid in comparison with patients receiving pamidronate.
Maltese: Analiżi ta' ħafna avvenimenti f'daqqa wrew tnaqqis sinifikanti ta' 16% tar-riskju f'pazjenti fuq kura b'zoledronic acid, meta mqabbla ma' pazjenti fuq pamidronate.
English: The results demonstrated that 4 mg zoledronic acid showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Maltese: Ir-riżultati wrew li 4 mg zoledronic acid kellu effikaċja komparabbli ma' 90 mg pamidronate fil-prevenżjoni ta' SREs.
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Maltese: fibrillazzjoni tal-atrija, anafilassi, marda tal-interstizju tal-pulmun.
English: In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Maltese: sigurtà fost it-tliet gruppi ttrattati (zoledronic acid 4 mg u zoledronic acid 8 mg u pamidronate) kien tal-istess mil-lat ta' tipi u severità.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 micromol/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 micromol/l jew <4.5 mg/dl (ara sezzjoni 4.4).
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
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 ma' l-għadam (SRE),
English: - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Maltese: - Prevenzjoni ta' problemi skelettriċi (ksur patoloġiku, kompressjoni tas-sinsla, radjazzjoni jew kirurġija fl-għadam, jew żieda fil-livell tal-kalċju fid-demm ikkawżat minn tumur) f'pazjenti adulti b'kanċer avvanzat li jinvolvi l-għadam.
English: TIH:
Maltese: Teл:
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: w/v soluzzjoni ta' sodium chloride jew 100ml 5% w/v glucose.
English: 5 ml concentrate in a plastic vial made of clear, colourless oleofinic polymer closed with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Maltese: bromobutyl miksi b'fluoropolymer, u b'tapp ta' l-aluminium b'komponent flip-off tal-plastik.
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 meqjusin li huma relatati mal-inibizzjoni tal-kompost tal-metabolizzazzjoni tal-calcium tal-iskeletru, li tirriżulta f'ipokalċimja ta' dawk li jkunu waslu biex iwelldu, effett tal-klassi tal-bisfosfonati, distoċja u waqfien qabel iżżmien tal-istudju.
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 ta' kalċju: taħbit tal-qalb irregolari (arritmija kardijaka;
English: < PC: {number} SN: {number} NN: {number} >
Maltese: AWTORIZZAZZJONI GĦAT-TQEGHID FIS-SUQ D.
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 'il 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: 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'zoledronic acid 4 mg kull 3-4 ġimgħat f'pazjenti tal-onkoloġija.
English: Proportion of patients with SREs p-value
Maltese: Proporzjon ta' pazjenti b'SREs (%) Valur-p
English: You will be given adequate calcium and vitamin D supplements.
Maltese: Inti ser tingħata supplimenti tal-kalċju u vitamina D adegwati.