FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 24.03.2003 Date of latest renewal: 20.03.2006
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24.03.2003
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Maltese: Id-deterjorament renali, il-progressjoni għall-insuffiċjenza renali u ddijaliżi ġew irrappurtati f'pazjenti wara d-doża tal-bidu jew wara doża waħda ta' 4 mg zoledronic acid (ara sezzjoni 4.4).
English: Remove the volume of Zometa 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 solution for injection.
Maltese: Neħħi l-volum indikat ta' soluzzjoni Zometa mill-flixkun u ssostitwixxih b'volum ugwali ta' 9 mg/ml sodium chloride sterili (0.9%) soluzzjoni għall-injezzjoni, jew 5% glucose soluzzjoni għall-injezzjoni.
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-parti l-kbira marbuta mat-tessut tal-għadam.
English: Stable for 24 hours at 2C - 8C after further dilution in 100 ml physiological saline or 5% w/v glucose solution.
Maltese: Stabbli għal 24 siegħa f'temperatura ta' bejn 2°C - 8°C, wara li jkun ddilwit f'100 ml ta' ilma bilmelħ fiżjoloġiku jew 5% w/v soluzzjoni ta' glucose.
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Maltese: Sabiex tħejji d-dożi mnaqqsa għal pazjenti b'bażi ta' CLcr ≤60 ml/min, irreferi għat-Tabella 1 hawn taħt.
English: Zometa is contraindicated in breast-feeding women (see section 4.3).
Maltese: Zometa huwa kontraindikat f'nisa li qed ireddgħu (ara sezzjoni 4.3).
English: Multipack comprising 4 packs, each containing 1 bottle.
Maltese: Pakkett multiplu li fih 4 pakketti, kull wieħed fih 1 flixkun.
English: Zometa 4 mg powder and solvent for solution for infusion, reconstituted and further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Maltese: Zometa 4 mg trab u solvent għal soluzzjoni għall-infużjoni, rikostitwit u ddilwit aktar f'100 ml (ara sezzjoni 6.6), għandha tingħata bħala infużjoni waħda għal ġol-vini f'mhux inqas minn 15-il minuta.
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: M'hemmx bżonn tibdil fid-doża f'pazjenti b'TIH li għandhom kreatinina fis-serum <400 µmol/l jew <4.5 mg/dl (ara sezzjoni 4.4).
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 perjodu 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: Solvent for Zometa Water for injections 5 ml
Maltese: Solvent għal Zometa Ilma għall-injezzjonijiet 5 ml
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 kontra l-mediċina tikkonsisti f'sensiela ta' sintomi li jinkludu deni, mijalġja, uġigħ ta' ras, uġigħ fl-estremitajiet, nawżja, rimettar, dijarea, altralġja u artrite b'nefħa sussegwenti filġogi.
English: Zometa should only be resumed when serum creatinine returns to within 10% of baseline.
Maltese: Zometa jista' jerġa' jingħata meta l-kreatinina fis-serum terġa' lura għal 10% tal-linja bażi.
English: One vial contains 4 mg of zoledronic acid.
Maltese: Kunjett wieħed fih 4 mg ta' zoledronic acid.
English: The diluted Zometa infusion solution should be used immediately in order to avoid microbial contamination.
Maltese: - Is-soluzzjoni għall-infużjoni ddilwita għandha tintuża minnufih sabiex tkun evitata kontaminazzjoni bil-mikrobi.
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: - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Maltese: - Kanċer, kundizzjonijiet li fl-istess waqt idgħajfu lill-pazjent (eż. anemija, mard tal koagulazzjoni, infezzjoni), it-tipjip.
English: The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Maltese: L-għoti ta' dożi sa 48 mg ta' zoledronic acid bi żball ġew irrappurtati.
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Maltese: Zoledronic acid ġie evalwat fil-firien għall-possibbiltà ta' effetti mhux mixtieqa fuq il-fertilità talġenerazzjoni parentali u ta' F1.
English: 0.5 mg/dl or 44 µmol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of
Maltese: Għall-pazjenti b'linja bażi normali ta' kreatinina fis-serum (<1.4 mg/dl jew <124 µmol/l), żieda ta' 0.5 mg/dl jew 44 µmol/l;
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Component of a multipack comprising 5 packs, each containing 1 bottle.
Maltese: Komponent ta' pakkett multiplu li fih 5 pakketti, kull wieħed fih 1 flixkun.
English: Acute phase reaction, pain
Maltese: Reazzjoni ta' fażi akuta, uġigħ
English: Component of a multipack comprising 4 packs, each containing 1 bottle.
Maltese: Komponent ta' pakkett multiplu li fih 4 pakketti, kull wieħed fih 1 flixkun.
English: Unit packs containing 1 or 4 vials and 1 or 4 ampoules of water for injections, respectively.
Maltese: Pakketti individwali li fihom 1 jew 4 kunjetti u 1 jew 4 ampulli b'ilma għall-injezzjoni, rispettivament.
English: 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; kawża ta' ipokalċimija).
English: NA
Maltese: MA
English: Low blood pressure.
Maltese: Pressjoni baxxa.
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-kalċju tal-iskeletru, li tirriżulta f'ipokalċimija ta' dawk li jkunu waslu biex iwelldu, effett tal-klassi tal-bisfosfonati, distoċja u waqfien qabel iż-żmien tal-istudju.
English: Aseptic techniques must be followed during the preparation of the infusion.
Maltese: Waqt il-preparazzjoni tal-infużjoni, għandhom jiġu segwiti tekniċi asettiċi.
English: High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation, abdominal pain, dry mouth.
Maltese: Pressjoni għolja, qtugħ ta' nifs, sturdament, ansjeta, disturb fl-irqad, disturbi fit-togħma, tregħid, tingiż jew titrix fl-idejn jew fis-saqajn, dijarea, stitikezza, uġigħ addominali, ħalq xott.
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 kalċju u 400 IU vitamina D kuljum.
English: Table 4 Efficacy results (breast cancer and multiple myeloma patients)
Maltese: Tabella 4 Riżultati li juru l-effikaċja (pazjenti b'kanċer fis-sider jew b'maeloma multipla)
English: Zometa is supplied as unit packs containing 1 or 4 vials and as multi-packs containing 10 (10x1) vials.
Maltese: Zometa jiġi f'pakketti individwali ta' 1 jew 4 kunjetti u bħala pakketti multipli li fihom 10 (10x 1) kunjetti.
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 darba bħala infużjoni ġol-vini fuq medda ta' 15-il minuta, f'pajp separat għall-infużjoni.
English: Dyspnoea, cough, bronchoconstriction
Maltese: Qtugħ ta' nifs, sogħla, għafis tal-bronki
English: Unit packs containing 1 or 4 vials.
Maltese: Pakketti individwali li fihom 1 jew 4 kunjetti.
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 mill-kliewi ta' zoledronic acid ġiet ikkorrelatata mat-tneħħija ta' kreatinina bi tneħħija millkliewi li tirrappreżenta 75 ± 33% tat-tneħħija tal-kreatinina, li wriet medja ta' 84 ± 29 ml/min (minn 22 sa 143 ml/min) fl-64 pazjent bil-kanċer li kienu studjati.
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: L-ammont miġbud tas-soluzzjoni rikostitwita għandu jiġi dilwit f'100 ml ta' soluzzjoni sterili ta' 0.9% w/v sodium chloride jew 5% w/v soluzzjoni ta' glucose.
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
Maltese: Il-proporzjon ta' pazjenti b'almenu SRE wieħed (bl-esklużjoni ta' iperkalċimija) kienet ta' 29.8% filgrupp ikkurat b'zoledronic acid kontra 49.
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with Zometa (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'4 mg ta' Zometa (zoledronic acid) kull 3-4 ġimgħat f'pazjenti talonkoloġija.
English: Arthritis and joint swelling as a symptom of acute phase reaction
Maltese: Artrite u nefħa fil-ġogi bħala sintomu ta' reazzjoni ta' fażi akuta
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Maltese: Ritmu irregolari tal-qalb (fibrillazzjoni tal-atrija) deher f'pazjenti li kienu qegħdin jingħataw zoledronic acid għall-osteoporożi ta' wara l-menopawża.
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 4 mg zoledronic acid kellu effikaċja komparabbli ma' 90 mg pamidronate fil-prevenżjoni ta' SREs.
English: Zometa 4 mg powder and solvent for solution for infusion zoledronic acid
Maltese: Zometa 4 mg trab u solvent għal soluzzjoni għall-infużjoni zoledronic acid
English: NR
Maltese: C.
English: Zometa 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Maltese: Zometa 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni zoledronic acid
English: One bottle contains 100 ml solution.
Maltese: Flixkun wieħed fih 100 ml soluzzjoni.
English: For storage conditions of the reconstituted solution for infusion, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna tas-soluzzjoni rikostitwita għall-infużjoni, ara sezzjoni 6.3.
English: Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Maltese: 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: In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Maltese: Fi studji kliniċi, il-kura b'Zometa reġgħet inbdiet biss meta l-livell ta' kreatinina kien reġa' ġie lura għal 10% tal-valur tal-linja bażi (ara sezzjoni 4.4).
English: Zometa 4 mg powder for solution for infusion zoledronic acid
Maltese: Zometa 4 mg trab għal soluzzjoni għall-infużjoni zoledronic acid
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 renali normali, definita bħala CLcr >60 ml/min, zoledronic acid 4 mg/100 ml soluzzjoni għall-infużjoni ma għandhiex tkun dilwita aktar.
English: Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Maltese: Pazjenti li jkollhom livelli għoljin fid-demm li ma jkunux ikkurati ġeneralment ikollhom xi grad ta' indeboliment tal-funzjoni renali, għaldaqstant monitoraġġ b'attenzjoni tal-funzjoni renali għandu jitqies.
English: To avoid potential incompatibilities, Zometa reconstituted solution is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibbiltajiet potenzjali, is-soluzzjoni rikostitwita ta' Zometa għandha tiġi ddilwita b'0.9% w/v soluzzjoni ta' sodium chloride jew b'5% w/v soluzzjoni ta' glucose.
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Maltese: Pressjoni għolja, pressjoni baxxa, fibrillazzjoni atrijali, pressjoni baxxa li twassal għal sinkope jew kollass ċirkolatorju
English: Table 2 Efficacy results (prostate cancer patients receiving hormonal therapy)
Maltese: Tabella 2 Riżultati li juru l-effikaċja (pazjenti b'kanċer tal-prostata li qed jieħdu kura b'ormoni)
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: Iż-żmien medjan sabiex beda l-ewwel SRE ma ntlaħaqx fil-fergħa kkurata b'zoledronic acid meta ntemm l-istudju u kien imtawwal b'mod sinifikanti meta mqabbel mal-plaċebo (p=0.007). Zoledronic acid 4 mg naqqas irriskju ta' SRE's b'41% f'analiżi ta' ħafna avvenimenti (proporzjon tar-riskju=0.59, p=0.019) meta mqabbel mal-plaċebo.
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Maltese: Dan għaliex tista' tiżviluppa anormalitajiet tal-elettroliti fis-serum (eż. livelli anormali ta' kalċju, fosfru u manjesju) u/jew bidliet fil-funzjoni tal-kliewi, inkluża insuffiċjenza severa tal-kliewi.
English: WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA TINTLEWA - REĊIPJENT TA' BAXXA TA' PAKKETT MULTIPLU (B'KAXX BLU)
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Maltese: III, 4 mg ta' zoledronic acid jew 90 mg ta' pamidronate, mogħtija kull 3 sa 4 gimgħat ġew imqabbla f'pazjenti b'maeloma multipla jew kanċer tas-sider li kellhom mill-inqas leżjoni waħda fl-għadam.
English: Withdraw an appropriate volume of the reconstituted solution (4 mg/5 ml) as needed: - 4.4 ml for 3.5 mg dose
Maltese: Iġbed volum xieraq tas-soluzzjoni rikostitwita (4 mg/5 ml) kif meħtieġ: - 4.4 ml għal doża ta' 3.5 mg
English: Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Maltese: Zoledronic acid ma jimpedixxix l-enzimi tal-bniedem P450 in vitro, ma jurix bijotrasformazzjoni, u fi studji li saru fuq annimali, <3% tad-doża mogħtija nstabet fl-ippurgar li jissuġġerixxi li l-funzjoni tal-fwied ftit li xejn għandha rwol rilevanti fil-farmakokinetiċi ta' zoledronic acid.
English: Zometa 4 mg 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: Zometa 4 mg konċentrat għal solulzzjoni għall-infużjoni, dilwita aktar f'100 ml (ara sezzjoni 6.6), għandha tingħata bħala infużjoni waħda għal ġol-vini f'mhux inqas minn 15-il minuta.
English: It is used:
Maltese: - In vivo:
English: The other ingredients are mannitol, sodium citrate, water for injections.
Maltese: Fih ukoll mannitol, sodium citrate u ilma għall-injezzjonijiet.
English: The following response rates were observed:
Maltese: Disturbi psikjatriċi Mhux komuni:
English: • To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Maltese: • Għall-prevenzjoni ta' kumplikazzjonijiet tal-għadam, eż. ksur, f'pazjenti adulti b'metastasi tal-għadam (firxa tal-kanċer minn sit primarju għall-għadam).
English: Headache
Maltese: Pożoloġija
English: Osteonecrosis of the jaw
Maltese: Osteonekrożi tax-xedaq
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Maltese: Taħbit irregolari tal-qalb (arritmija tal-qalb), aċċessjonijiet, spażmu u ġbid tal-muskoli għal għarrieda (tetanja) kienu rrappurtati kawża ta' ipokalċimija qawwija.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Maltese: Deni, sindrome li tixbah l-influwenza (inklużi għeja, tertir, tħossok marid u ssir ruxxan)
English: AMPOULE LABEL
Maltese: MA Mhux Applikabbli
English: 1 bottle contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.
Maltese: 1 flixkun fih 4 mg zoledronic acid, daqs 4.264 mg zoledronic acid monohydrate.
English: Zometa 4 mg/5 ml concentrate for solution for infusion
Maltese: Zometa 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni
English: Hypophosphataemia
Maltese: Edima anġjonewrotika
English: Zometa 4 mg powder and solvent for solution for infusion
Maltese: Zometa 4 mg trab u solvent għal soluzzjoni għall-infużjoni
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 ma ġewx determinati s'issa.
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Maltese: Fi studji ta' Fażi I għat-tfittxija tad-doża li għandha tingħata f'pazjenti b'TIH ta' grad ħafif sa moderat, id-dożi effettivi li ġew ittestjati kienu fil-medda ta' madwar 1.2-2.5 mg.
English: FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AND 4 AMPOULES AS UNIT PACK (INCLUDING BLUE BOX
Maltese: KAXXA TINTLEWA GĦAL KUNJETT 1 U AMPULLA 1 BĦALA PAKKETT INDIVIDWALI (KAXXA ĊELESTI INKLUŻA) KAXXA TINTLEWA GĦAL 4
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy.
Maltese: Ġiet irrapportata osteonekrożi tal-kanal estern tas-smigħ bil-bifosfonati, prinċipalment assoċjata ma' terapija fit-tul.
English: One vial with 5 ml concentrate for solution for infusion Component of a multipack comprising ten packs, each containing one vial
Maltese: Kunjett wieħed b'5 ml ta' konċentrat għal soluzzjoni għall-infużjoni Jagħmel parti minn pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1.
English: One vial with 5 ml concentrate contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.
Maltese: U KWANTITATTIVA Kunjett wieħed fih 5 ml konċentrat li fih 4 mg zoledronic acid, ekwivalenti għal 4.264 mg zoledronic acid monohydrate.
English: Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Maltese: Żieda fil-ħin tal-infużjoni minn 5 għal 15-il minuta, ikkawżat tnaqqis ta' 30% filkonċentrazzjoni ta' zoledronic acid fi tmiem l-infużjoni, iżda ma kellha l-ebda effett fuq l-erja taħt ilkurva ta' konċentrazzjoni fil-plażma kontra l-ħin.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 5.1 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as Zometa (see section 4.4).
Maltese: Każijiet ta' osteonekrożi (tax-xedaq) kienu rrappurtati, l-aktar f'pazjenti bil-kanċer ikkurati bi prodotti mediċinali li jinibixxu r-risorbiment tal-għadam, bħal Zometa (ara sezzjoni 4.4).
English: Zometa is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Maltese: Zometa mhux irrakkomandat għall-pazjenti li jkollhom indeboliment sever tal-kliewi qabel tibda t-terapija, li għal din il-popolazzjoni hi meqjusa bħala CLcr <30 ml/min.
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 jitnaqqas ir-riskju b'doża ta' 4 mg zoledronic acid li tingħata fuq medda ta' 15-il minuta, xorta waħda l-funzjoni tal-kliewi tista' tmur għall-agħar.
English: Component of a multipack comprising ten packs, each containing one vial and one ampoule
Maltese: Jagħmel parti minn pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1 u ampulla 1.
English: Table 3 Efficacy results (prostate cancer patients receiving hormonal therapy)
Maltese: Tabella 3 Riżultati li juru l-effikaċja (pazjenti b'kanċer tal-prostata li qed jieħdu kura b'ormoni)
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 għall-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, minħabba li meta jingħataw flimkien ma' bisfosfonati jistgħu jniżżlu l-livell tal-kalċju fid-demm għal wieħed baxx wisq.
English: The amount of reconstituted solution as required is then further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Maltese: Issoluzzjoni rrikostitwita terġa' mbagħad tiġi ddilwita b'100 ml soluzzjoni għall-infużjoni li ma jkunx fiha kalċju (0.9% w/v soluzzjoni ta' sodium chloride jew 5%w/v soluzzjoni ta' glucose).