FrancophonIA/ELRC3.0 huggingface dataset:
English: It is given as a single 15-minute intravenous infusion in a separate infusion line.
Maltese: Tingħata darba bħala infużjoni ġol-vini fuq medda ta' 15-il minuta f'linja ta' infużjoni separata.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ 0.24 and t½ 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½ 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 146 sigħat.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Maltese: Mediċini għall-kura ta' mard tal-għadam, bisfosfonati, Kodiċi ATC:
English: EU/1/01/176/004 1 vial EU/1/01/176/005 4 vials
Maltese: EU/1/01/176/004 kunjett 1 EU/1/01/176/005 4 kunjetti
English: - History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
Maltese: - Storja ta' mard dentali, iġjene orali dgħajfa, mard perjodontali, proċeduri dentali invażivi (eż.
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 Zometa is not recommended in patients with severe renal impairment.
Maltese: Minħabba l-impatt potenzjali ta' zoledronic acid fuq il-funzjoni tal-kliewi, u minħabba nuqqas ta' tagħrif kliniku dwar is-sigurtà f'pazjenti b'indeboliment sever tal-kliewi (iddefinit fi provi kliniċi bħala livell ta' kreatinina fis-serum ta' 400 µmol/l jew 4.5 mg/dl għal pazjenti b'TIH u 265 µmol/l jew 3.0 mg/dl għal pazjenti b'kanċer u metastasi fl-għadam, rispettivament) fil-linja bażi u minħabba t-tagħrif farmakokinetiku limitat f'pazjenti li fil-linja bażi għandhom indeboliment sever fil-funzjoni tal-kliewi (tneħħija tal-kreatinina <30 ml/min), l-użu ta' Zometa f'pazjenti b'indeboliment sever filfunzjoni tal-kliewi mhux irrakkomandat.
English: Date of first authorisation: 20.03.2001 Date of latest renewal: 20.03.2006
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20.03.2001
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 kkunsidrati meta jiġi evalwat ir-riskju ta' individwu li jiżviluppa ONJ: - Potenza tal-bisfosfonat (riskju ogħla għal komposti potenti ħafna), mnejn jingħata (riskju ogħla għal għoti parenterali) u doża kumulattiva ta' bisphosphonate.
English: For patients with normal renal function (defined as CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml solution for infusion may be administered directly without any further preparation.
Maltese: Għal pazjenti b'funzjoni renali normali (definita bħala CLcr >60 ml/min), zoledronic acid 4 mg/100 ml soluzzjoni għall-infużjoni tista' tingħata direttament mingħajr aktar preparazzjoni.
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 sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: In clinical trials with Zometa, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Maltese: Fi provi kliniċi b'Zometa, pazjenti b'kreatinina fis-serum ta' >265µmol/l jew >3.0 mg/dl kienu esklużi.
English: The following are the important identified risks with Zometa in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Maltese: Indeboliment tal-funzjoni renali, osteonekrożi tax-xedaq, reazzjoni ta' fażi akuta, ipokalċimija, fibrillazzjoni tal-atrija, anafilassi, marda tal-interstizju tal-pulmun.
English: Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Maltese: Hemm biss tagħrif farmakokinetiku limitat f'pazjenti b'insuffiċjenza severa tal-kliewi (tneħħija tal-kreatinina <30 ml/min).
English: In a pooled analysis of safety data from Zometa registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to Zometa (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Maltese: F'ġabra ta' analiżijiet dwar is-sigurtà waqt il-provi ta' reġistrazzjoni ta' Zometa għall-prevenzjoni ta' problemi skelettriċi f'pazjenti li għandhom kanċer avanzat li jinvolvi l-għadam, il-frekwenza ta' episodji avversi ta' indeboliment talkliewi li jistgħu jkunu relatati ma' Zometa (reazzjonijiet avversi) kienet kif ġej: maeloma multipla (3.2%), kanċer tal-prostata (3.1%), kanċer tas-sider (4.3%), tumuri tal-pulmun u tumuri solidi oħrajn (3.2%).
English: 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 fisserum ta' >400 µmol/l jew >4.5 mg/dl kienu esklużi.
English: Pruritus, rash (including erythematous and macular rash), increased sweating
Maltese: Ħakk, raxx, (inklużi raxx bi ħmura u dak makulari), żieda fl-għaraq
English: Acute renal failure, haematuria, proteinuria
Maltese: Insuffiċjenza renali, ħematurja, proteinurja
English: Zometa 4 mg/100 ml solution for infusion zoledronic acid
Maltese: Zometa 4 mg/100 ml soluzzjoni għall-infużjoni zoledronic acid
English: - 4.1 ml for 3.3 mg dose
Maltese: - 4.1 ml għal doża ta' 3.3 mg
English: - 3.8 ml for 3.0 mg dose
Maltese: - 3.8 ml għal doża ta' 3.0 mg
English: Zometa contains the same active substance as found in Aclasta (zoledronic acid).
Maltese: Zometa fih l-istess sustanza attiva li tinsab f'Aclasta (zoledronic acid).
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Maltese: Fil-programm kliniku pazjenti li l-età tagħhom kienet minn sena sa <3 snin irċivew 0.025 mg/kg zoledronic acid (sad-doża waħda massima ta' 0.35 mg) kull 3 xhur u pazjenti li l-età tagħhom kienet minn 3 snin sa 17-il sena rċivew 0.05 mg/kg zoledronic acid (sad-doża waħda massima ta' 0.83 mg) kull 3 xhur.
English: NR NR NR 640
Maltese: MM MM MM 640
English: Multipack comprising ten packs, each containing one vial and one ampoule of solvent 5 ml.
Maltese: Jagħmel parti minn pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1 u ampulla 1 b'5 ml solvent.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (tista' taffettwa sa persuna 1 minn kull 1,000):
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: Overhydration should be avoided in patients at risk of cardiac failure.
Maltese: Għandha tiġi evitata l-idratazzjoni eċċessiva f'pazjenti li għandhom riskju ta' insuffiċjenza kardijaka.
English: Vial: 5-ml plastic vial made of clear, colourless cycloolefine copolymer with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Maltese: Kunjett magħmula minn cycloolefine copolymer ċar u bla kulur b'tapp tal-lasktu ta' bromobutyl miksi b'fluoropolymer, u b'tapp ta' l-aluminium b'komponent flip-off tal-plastik.
English: Zometa 4 mg/100 ml solution for infusion
Maltese: Zometa 4 mg/100 mg soluzzjoni għall-infużjoni
English: NA NA NA NA
Maltese: U MNEJN GĦANDU JINGĦATA
English: In paediatric patients with severe osteogenesis imperfecta, zoledronic acid seems to be associated with more pronounced risks for acute phase reaction, hypocalcaemia and unexplained tachycardia, in comparison to pamidronate, but this difference declined after subsequent infusions.
Maltese: F'pazjenti pedjatriċi b'osteoġenesi imperfetta severa, zoledronic acid jidher li huwa assoċjat ma' riskji li 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: Solvent ampoule: 5-ml colourless glass ampoule.
Maltese: Ampulla tas-solvent: 5 ml ampulla magħmula minn ħġieġ bla kulur.
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: Iżżmien medjan biex jerġa' jogħla (il-livell tal-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 s-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: 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: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Maltese: Sturdament, parasteżija, disgewżja, ipoesteżija, iperesteżija, tregħid, ħedla ta' ngħas
English: Muscle spasms, osteonecrosis of the jaw
Maltese: Spażmi fil-muskoli, osteonekrożi tax-xedaq
English: In patients with mild to moderate renal impairment, reduced Zometa 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' Zometa (ara s-sezzjoni “Pożoloġija” hawn fuq u s-sezzjoni 4.4).
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 maleffetti 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: Hypersensitivity reactions.
Maltese: Reazzjonijiet ta' sensittività eċċessiva.
English: Bone pain, myalgia, arthralgia, generalised pain
Maltese: Uġigħ fl-għadam, mijalġja, artralġja, uġigħ mal-ġisem kollu
English: Day 4
Maltese: Dublin 4
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 randomizzat, double-blind u kkontrollat bi plaċebo qabbel zoledronic acid 4 mg ma' plaċebo fil-prevenzjoni ta' effetti skelettriċi (SRE) f'pazjenti b'kanċer tal-prostata.
English: 3.8 ml for 3.0 mg dose
Maltese: 3.8 ml għal doża ta' 3.0 mg
English: The active substance of Zometa is zoledronic acid.
Maltese: X'fih Zometa - Is-sustanza attiva ta' Zometa hi zoledronic acid.
English: Clinical experience with acute overdose of Zometa is limited.
Maltese: L-esperjenza klinika b'doża eċċessiva akuta ta' Zometa hija limitata.
English: Zometa 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
Maltese: Zometa 4 mg/100 ml soluzzjoni għall-infużjoni fiha 4 mg ta' zoledronic acid f'100 ml soluzzjoni għall-infużjoni għall-użu immedjat f'pazjenti b'funzjoni renali normali.
English: Replace with the following volume of sterile sodium chloride 9 mg/ml (0,9%) or 5% glucose solution for injection (ml)
Maltese: Issostitwixxi b'dan ilvolum ta' sodium chloride sterili 9 mg/ml (0.9%), jew 5% glucose soluzzjoni għal injezzjoni (ml)
English: Powder vial:
Maltese: Huwa jintuża:
English: 4.1 ml for 3.3 mg dose
Maltese: 4.1 ml għal doża ta' 3.3 mg
English: Sodium citrate Water for injections
Maltese: Sodium citrate Ilma għall-injezzjonijiet
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 ta' 37% jew 72%, rispettivament meta mqabbla ma' pazjenti bi tneħħija tal-kreatinina ta' 84 ml/min.
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 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 rrappurtaw inqas żieda fl-uġigħ minn dawk li kienu fuq plaċebo, u d-differenza kienet sinifikanti fit-3, 9, 21 u 24 xhar.
English: Additional information on handling of Zometa, including guidance on the preparation of reduced doses using the Zometa ready-to-use bottle, is provided in section 4.2.
Maltese: Informazzjoni addizzjonali dwar l-immanniġġar ta' Zometa, inkluż gwida dwar il-preparazzjoni ta' dożi mnaqqsa hija pprovduta fis-sezzjoni 4.2.
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 4mg kien studjat ukoll fi prova double-blind, randomizzata, ikkontrollata bi plaċebo f'228 pazjent b'metastasi tal-għadam iddokumentata minn kanċer tas-sider sabiex ikun evalwat l-effett ta' 4 mg ta' zoledronic acid fuq ir-rata tal-proporzjon tal-każijiet relatati mal-għadam (SRE), ikkalkulat bħala n-numru totali ta' każijiet ta' SRE (bl-esklużjoni ta' iperkalċimija u rranġata għallqabel il-ksur), diviż mat-totali tal-perjodu ta' riskju.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following Zometa dose is recommended (see also section 4.4):
Maltese: F'pazjenti b'metastasi tal-għadam li jkollhom indeboliment tal-kliewi ħafif għal moderat qabel tibda tterapija, li għal din il-popolazzjoni titqies bħala CLcr 30-60 ml/min, huma rrakkomandati dożi mnaqqsa ta' Zometa (ara wkoll sezzjoni 4.4):
English: Zometa can be given to people aged 65 years and over.
Maltese: Zometa jista' jingħata lill-persuni li għandhom 65 sena jew aktar.
English: Immune system disorders Uncommon:
Maltese: Disturbi fis-sistema immuni Mhux komuni:
English: Day 10
Maltese: 10 Ġurnata
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Maltese: Ħafna minn dawn ilpazjenti kienu qed jirċievu wkoll kimoterapija u kortikosterojdi u kellhom sinjali ta' infezzjoni lokali inkluż osteomaelitis.
English: Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
Maltese: Pazjenti li ngħataw dożi ogħla minn dawk irrakkommandati (ara sezzjoni 4.2) għandhom jiġu mgħassa bir-reqqa peress li dehru indeboliment tal-funzjoni renali (inkluża insuffiċjenza renali) u anormalitajiet tal-elettroliti fis-serum (inklużi kalċju, fosfru u manjesju).
English: Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Maltese: Zoledronic acid ma kienx mutaġenetiku f'testijiet għall-mutaġeniċità, filwaqt li testijiet għallkarċinoġeniċità ma indikawx li għandu potenzjal karċinoġeniku.
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: 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: 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 ġimgħa u ma' kull punt sussegwenti waqt l-istudju, meta mqabbel mal-plaċebo (Figura 1).
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zometa is used in combination with thalidomide.
Maltese: F'pazjenti b'maeloma multipla, ir-riskju ta' disfunzjoni tal-kliewi jista' jiżdied meta Zometa jintuża flimkien ma' thalidomide.
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, ipoestesija u tetanja) ġew irrappurtati kawża ta' każijiet ta' ipokalċimija qawwija.
English: Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Maltese: Zoledronic acid ma jiġix immetabolizzat u jiġi eliminat fi stat mhux mibdul mill-kliewi.
English: In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
Maltese: Fi provi kliniċi, 69 pazjent li rkadew jew ma kellhomx effett bl-ewwel kura (b'zoledronic acid 4 mg, 8 mg jew pamidronate 90 mg), reġgħu ngħataw 8 mg zoledronic acid.
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 avanzat li jinvolvi l-għadam.
English: Multipack comprising 5 packs, each containing 1 bottle.
Maltese: Pakkett multiplu li fih 5 pakketti, kull wieħed fih 1 flixkun.
English: Within three days after Zometa administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Maltese: Fi żmien tlett ijiem wara l-għoti ta' Zometa, ġiet irrappurtata spiss reazzjoni ta' fażi akuta, b'sintomi li jinkludu uġigħ fl-għadam, deni, għeja, artralġja, mijalġja, tertir u artrite b'nefħa sussegwenti fil-ġogi; dawn is-sintomi normalment jgħaddu fi ftit ġranet (ara d-deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Table 1 Preparation of reduced doses of Zometa 4 mg/100 ml solution for infusion
Maltese: Tabella 1 Tħejjija ta' dożi mnaqqsa ta' Zometa 4 mg/100 ml soluzzjoni għall-infużjoni
English: Figure 1 Mean changes from baseline in BPI scores.
Maltese: Figura 1 Medja tal-bidliet mil-linja bażi fil-punteġġi BPI.
English: Fewer zoledronic acid 4 mg patients suffered pathological fractures.
Maltese: Pazjenti fuq zoledronic acid 4 mg sofrew anqas ksur patoloġiku.
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 imperfetta severa f'pazjenti pedjattriċi mill-età ta' sena sa 17-il sena
English: 100 ml solution in a transparent, colourless, plastic (cycloolefinic copolymer) bottle closed with a fluorocarbon polymer coated bromobutyl rubber stopper and an aluminum cap with a flip-off component of polypropylene.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Soluzzjoni ta' 100 ml fi flixkun trasparenti, bla kulur tal-plastik (cycloolefinic copolymer) magħluq b'tapp tal-lastiku tal-bromobutyl miksi b'polimeru tal-fluworkarbonju u b'kappa tal-aluminju b'komponent li jfaqqa' meta jinfetaħ tal-polypropylene.
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' kalċju fis-serum korrett għall-albumina 12.0 mg/dl jew 3.0 mmol/l) hija doża singola ta' 4 mg zoledronic acid.
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-għotja ripetuta tal-mediċina fuq żmien itwal b'dożi li laħqu l-ogħla doża terapewtika ta' zoledronic acid intenzjonata għall-bniedem ikkawżat effetti tossikoloġiċi f'organi oħrajn, inkluż fis-sistema gastrointestinali, fil-fwied, fil-milsa u fil-pulmun, u fil-postijiet minn fejn ikunu ngħataw linjezzjoniet ġol-vini.
English: Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zometa.
Maltese: - Studji b'diversi tipi ta' linji għall-infużjoni magħmulin minn polyvinyl chloride, polyethylene u polypropylene ma wrew ebda inkompatibbiltà ma' Zometa.
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 (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Maltese: Qabel ma tiġi mogħtija, 5.0 ml konċentrat minn kunjett wieħed għandu jiġi ddilwit b'100 ml ta' soluzzjoni għall-infużjoni mingħajr kalċju (0.9% w/v soluzzjoni ta' sodium chloride jew 5% w/v soluzzjoni ta' glucose).