FrancophonIA/ELRC3.0 huggingface dataset:
English: − In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, antiadhesion/invasion activity.
Maltese: Inibizzjoni tal-proliferazzjoni ta' osteoblasts u attività diretta ċitostatika u proapoptotika fuq ċelluli tat-tumur, effett ċitostatiku u sinerġistiku ma' prodotti mediċinali oħrajn kontra l-kanċer, u attività kontra l-adeżjoni/invażjoni.
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Maltese: Zoledronic acid hu kontra-indikat waqt treddigħ (ara sezzjoni 4.3).
English: Adjusted dose (mg zoledronic acid in 100 ml)
Maltese: Doża aġġustata (mg ta' zoledronic acid f'100 ml)
English: 1 x 5 ml vial
Maltese: 1 x 5 mL kunjett
English: There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Maltese: Kien hemm normalizzazzjoni iktar mgħaġġla ta' calcium fis-serum ikkoreġut f'jum 4 għal 8 mg zoledronic acid u f'jum 7 għal 4 mg u 8 mg zoledronic acid.
English: Excipients: mannitol, sodium citrate, water for injections.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: mannitol, sodium citrate, ilma għall-injezzjonijiet.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing) Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Maltese: Deni, sindromu li jixbah l-influwenza (li jinkludi għeja, tertir, telqa u fwawar) Astenja, edema periferali, reazzjonijiet fis-sit tal-injezzjoni (li jinkludu wġigħ, irritazzjoni, nefħa, ebusija), uġigħ fis-sider, żieda fil-piż, reazzjoni anafilattika/xokk anafilattiku, urtikarja
English: In use stability: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 2-8°C and 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu wara d-dilwizzjoni ntweriet għal 24 siegħa f'temperatura ta' 2-8°C u 25°C.
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 hi ta' 5.04 ± 2.5 l/siegħa, hi indipendenti mid-doża, u ma tiġix affettwata mis-sess tal-persuna, età, razza u piż tal-ġisem.
English: − For patients with normal baseline serum creatinine (< 1.4 mg/dl or 124 µmol/l), an increase of
Maltese: • Għal pazjenti bi kreatinina fis-serum fil-linja bażi anormali (> 1.4 mg/dl jew > 124 µmol/l),
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: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Maltese: Il-parametri metaboliċi standard relatati ma' iperkalċemija, bħal livelli fis-serum ta' kalċju, fosfat u manjesju, għandhom jiġu mmonitorjati bir-reqqa wara li tinbeda t-terapija b'zoledronic acid.
English: One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Maltese: 1 ml ta' konċentrat fih 0.8 mg ta' zoledronic acid (bħala monohydrate).
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
Maltese: Qed tintuża l-klassifikazzjoni 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 < 1/1,000), rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
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 normali tal-kliewi (definita bħala CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml soluzzjoni għall-infużjoni tista' tingħata direttament mingħajr preparazzjoni addizzjonali.
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: Fi provi kliniċi li twettqu fuq pazjenti b'iperkalċemija kkawżata minn tumur (TIH), il-profil ta' sigurtà globali fost it-tliet gruppi kollha tal-kura (zoledronic acid 4 u 8 mg u pamidronate 90 mg) kien simili fir-rigward ta' tipi u severità.
English: In a pooled analysis of safety data from zoledronic acid 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 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'analiżi miġbura tad-dejta dwar is-sigurtà minn provi ta' reġistrazzjoni ta' zoledronic acid għall-prevenzjoni ta' każijiet skelettriċi relatati f'pazjenti b'tumuri malinni avanzati li jinvolvu l-għadam, il-frekwenza ta' każijiet avversi ta' indeboliment tal-kliewi li kienu ssuspettati li huma relatati ma' zoledronic acid (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: - Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Maltese: − Ritmu irregolari tal-qalb (fibrillazzjoni atrijali) ġiet osservata f'pazjenti li kienu qed jirċievu zoledronic acid għall-osteoporosi ta' wara l-menopawsa.
English: Landeggerstrasse 7 A-2491 Neufeld/Leitha Austria medac
Maltese: 2491 Neufeld / Leitha L-Awstrija medac
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Maltese: − Mediċini antianġjoġeniċi (li jintużaw għal kura tal-kanċer), għax il-kombinazzjoni ta' dawn ma' zoledronic acid ġiet assoċjata ma' żieda fir-riskju ta' osteonekrosi tax-xedaq (osteonecrosis of the jaw , ONJ).
English: Patients aged 65 years and over
Maltese: Pazjenti li għandhom 65 sena jew iżjed
English: • Zoledronic acid medac 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: • Zoledronic acid medac 4 mg/100 ml soluzzjoni għall-infużjoni fih 4 mg ta' zoledronic acid f'100 ml ta' soluzzjoni għall-infużjoni għal użu immedjat f'pazjenti b'funzjoni normali talkliewi.
English: Additional information on handling of Zoledronic acid medac, including guidance on preparation of reduced doses, is provided in section 4.2.
Maltese: Informazzjoni addizzjonali dwar l-immaniġġjar ta' Zoledronic acid medac, li tinkludi gwida dwar il-preparazzjoni ta' dożi mnaqqsa, hi pprovduta f'sezzjoni 4.2.
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'mill-inqas SRE wieħed (bl-esklużjoni ta' iperkalċemija) kien ta' 29.8 % fil-grupp ikkurat b'zoledronic acid kontra 49.6 % fil-grupp tal-plaċebo (p=0.003).
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 li damet 3 snin, li fiha l-parteċipanti ntgħażlu b'mod każwali, ikkontrollata u double-blind, li evalwat l-effikaċja u s-sigurtà ta' zoledronic acid 5 mg darba fis-sena vs. plaċebo fil-kura ta' osteoporożi ta' wara l-menopawsa (PMO), l-inċidenza globali ta' fibrillazzjoni atrijali kienet ta' 2.5 % (96 minn 3,862) u 1.9 % (75 minn 3,852) f'pazjenti li kienu qed jirċievu 5 mg ta' zoledronic acid u plaċebo, rispettivament.
English: Zoledronic acid medac contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodium-free'.
Maltese: Zoledronic acid medac fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
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 rakkomandata għall-kura ta' iperkalċemija (livell ta' calcium fis-serum ikkoreġut għall-albumina ≥ 12.0 mg/dl jew 3.0 mmol/l) hi doża waħda ta' 4 mg ta' zoledronic acid.
English: One ml solution contains 0.04 mg zoledronic acid (as monohydrate).
Maltese: 1 ml ta' soluzzjoni fih 0.04 mg ta' zoledronic acid (bħala monohydrate).
English: The following are the important identified risks with zoledronic acid 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 tal-kliewi, osteonekrosi tax-xedaq, reazzjoni ta' fażi akuta, ipokalċemija, fibrillazzjoni atrijali, anafilassi, marda tal-interstizju tal-pulmun.
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 għal rikaduta (żieda mill-ġdid ta' kalċju fis-serum ikkoreġut għall-albumina ta' ≥ 2.9 mmol/l) kien ta' 30 sa 40 jum għal pazjenti kkurati b'zoledronic acid kontra s-17-il jum għal dawk ikkurati b'pamidronate 90 mg (valuri p: 0.001 għal 4 mg u 0.007 għal 8 mg zoledronic acid).
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 5,000 ng/ml.
Maltese: Fi studju in vitro, zoledronic acid wera affinità baxxa għall-komponenti ċellulari tad-demm uman, bi proporzjon ta' konċentrazzjoni medja ta' demm għal plażma ta' 0.59 f'firxa ta' konċentrazzjonijiet ta' 30 ng/mL sa 5,000 ng/ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/001<1 vial>
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/779/001 <1 vial>
English: Colourless glass bottle type I with fluoropolymer coated halobutyl rubber stopper and aluminium flipoff cap.
Maltese: Flixkun tal-ħġieġ ta' tip I, b'tapp tal-lastku tal-fluoropolymer miksi bil-halobutyl, u siġill tat-tip flipoff tal-aluminju.
English: Uncommon: Rare:
Maltese: Mhux komuni: Rari ħafna:
English: Zoledronic acid has been associated with reports of renal dysfunction.
Maltese: Zoledronic acid ġie assoċjat ma' rapporti ta' disfunzjoni tal-kliewi.
English: Zoledronic acid medac 4mg/5ml concentrate for solution for infusion Sanochemia Pharmazeutika AG
Maltese: Zoledronic acid medac 4mg/5ml konċentrat għal soluzzjoni għall-infużjoni Sanochemia Pharmazeutika AG
English: In the event of hypocalcaemia, calcium gluconate infusions should be administered as clinically indicated.
Maltese: F'każ ta' ipokalċemija, infużjonijiet ta' calcium gluconate hekk kif ikun indikat klinikament.
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 livell ta' kreatinina fis-serum ta' > 400 µmol/l jew > 4.5 mg/dl ġew esklużi.
English: Chemical and physical in-use stability has been demonstrated for glass bottles, polyethylene, polyvinylchloride and polypropylene infusion lines and infusion bags (prefilled with sodium chloride 9 mg/ml (0.9 %) solution for injection or 5 % w/v glucose solution) for 96 hours at 2-8°C and 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal fliexken tal-ħġieġ, pajpijiet tal-infużjoni u boroż tal-infużjoni tal-polyethylene, polyvinylchloride u polypropylene (mimlija għal-lest b'sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni jew 5 % w/v soluzzjoni ta' glucose) għal 96 siegħa f'temperatura ta' 2-8°C u 25°C.
English: • Studies with glass bottles, several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution) showed no incompatibility with zoledronic acid.
Maltese: • Studji li saru dwar fliexken tal-ħġieġ u diversi tipi ta' boroż tal-infużjoni u linji tal-infużjoni magħmula minn polyvinylchloride, polyethylene u polypropylene (mimlija għal-lest b' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride jew 5% w/v soluzzjoni ta' glucose), ma wrew l-ebda inkompatibilità ma' zoledronic acid.
English: The analysis of the individual safety reports from clinical trials, spontaneous reports and literature retrieved 62 cases of osteonecrosis of other anatomical sites in association with zoledronic acid, with the majority of events occurring in the hip/femur (46).
Maltese: L-analiżi tar-rapporti individwali tas-sigurtà minn provi kliniċi, rapporti spontanji u mill-letteratura kisbet 62 każ ta' osteonekrożi ta' siti anatomiċi oħra assoċjati ma' zoledronic acid, bil-maġġoranza talavvenimenti jseħħu fil-ġenbejn/wirk (46).
English: Table 1: Preparation of reduced doses of Zoledronic acid medac 4 mg/100 ml solution for infusion
Maltese: Tabella 1: Preparazzjoni ta' dożi mnaqqsa ta' Zoledronic acid medac 4 mg/100 ml soluzzjoni għallinfużjoni
English: After first opening: Chemical and physical in-use stability has been demonstrated for 4 days at 2 - 8°C and 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 4 sigħat f'temperatura ta' 2 - 8°C u 25°C.
English: Bone pain, myalgia, arthralgia, generalised pain
Maltese: Uġigħ fl-għadam, mijalġja, artralġja, uġigħ ġeneralizzat
English: There is preponderance of specific location (head of femur, humerus and medial condyle of femur) due to local anatomical features.
Maltese: Hemm prevalenza ta' postijiet speċifiċi (ir-ras tal-wirk, l-omeru u l-condyle medjan tal-wirk) minħabba karatteristiċi anatomiċi lokali.
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 P450 umani in vitro, ma juri l-ebda bijotrasformazzjoni, u fi studji fuq l-annimali, < 3% tad-doża mogħtija ġiet irkuprata fl-ippurgar, u dan jissuġġerixxi li m'hemm l-ebda rwol rilevanti tal-funzjoni tal-fwied fil-farmakokinetika ta' zoledronic acid.
English: Aseptic techniques must be followed during the preparation of the infusion.
Maltese: Tekniki asettiċi jridu jiġu segwiti waqt il-preparazzjoni tal-infużjoni.
English: Dystocia was observed at the lowest dose (0.01 mg/kg bodyweight) tested in the rat.
Maltese: Ġiet osservata distoċija fl-iktar doża baxxa (0.01 mg/kg piż tal-ġisem) ittestja fil-firien.
English: Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Maltese: Iġbed volum adattat tas-soluzzjoni meħtieġa, kif ġej: - 4.4 ml għal doża ta' 3.5 mg
English: • History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures.
Maltese: • Storja ta' mard dentali, iġjene orali dgħajfa, mard perjodontali, proċeduri dentali invażivi (eż. qlugħ ta' snien) u dentaturi li ma jeħlux tajjeb.
English: Rare: Very rare:
Maltese: Rari ħafna:
English: 1 Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well-established safety profile of zoledronic acid (see section 4.8)
Maltese: Ipokalċemija Ipofosfatemija 1 Reazzjonijiet avversi li seħħew bi frekwenzi ta' < 5% ġew evalwati b'mod mediku u ntwera li dawn il-każijiet kienu konsistenti mal-profil ta' sigurtà stabbilit tajjeb ta' zoledronic acid (ara sezzjoni 4.8).
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),
Maltese: 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-dejta disponibbli).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Maltese: U KWANTITATTIVA Kunjett wieħed b'5 ml ta' konċentrat fih 4 mg ta' zoledronic acid (bħala monohydrate).
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 pazjent bi tneħħija tal-kreatinina ta' 20 ml/min (indeboliment sever tal-kliewi), jew 50 ml/min (indeboliment moderat), it-tneħħija korrispondenti mbassra ta' zoledronic acid tkun ta' 37% jew 72%, rispettivament, ta' dik ta' pazjenti bi tneħħija tal-kreatinina ta' 84 ml/min.
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skelettriċi u tat-tessuti konnettivi
English: Zoledronic acid medac is supplied as unit packs containing 1 vial or 4 vials and as multipacks of 4 or 10 packs each containing 1 vial.
Maltese: Zoledronic acid medac hu fornut bħala pakketti li jkun fihom flixkun 1 jew bħala pakketti multipli li jkun fihom 4 jew 10 pakketti, li kull wieħed ikun fih 1 flixkun.
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 rċivew dożi ogħla minn dawk irrakkommandati (ara sezzjoni 4.2) għandhom jiġu mmonitorjati bir-reqqa, biili ġew osservati indeboliment fil-funzjoni tal-kliewi (inkluża insuffiċjenza tal-kliewi) u anormalitajiet tal-elettroliti fis-serum (li jinkludu kalċju, fosfru u manjesju).
English: 1 bottle of 100 ml.
Maltese: Flixkun 1 ta' 100 mL.
English: Each vial contains 5 ml of concentrate.
Maltese: Kull kunjett fih 5 mL ta' konċentrat.
English: Limited pharmacokinetic data in children with severe osteogenesis imperfecta suggest that zoledronic acid pharmacokinetics in children aged 3 to 17 years are similar to those in adults at a similar mg/kg dose level.
Maltese: Dejta farmakokinetika limitata fi tfal b'osteoġenesi imperfecta severa tissuġġerixxi li l-farmakokinetika ta' zoledronic acid fi tfal li għandhom minn 3 sa 17-il sena hi simili għal dik fladulti f'livell simili ta' doża f'mg/kg.
English: Pruritus, rash (including erythematous and macular rash), increased sweating
Maltese: Ħakk, raxx, (li jinkludi raxx eritematuż u makulari), żieda fl-għaraq
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: Deterjorament talkliewi, progressjoni għal insuffiċjenza tal-kliewi u dijalisi ġew irrappurtati f'pazjenti wara d-doża inizjali jew doża waħda ta' 4 mg ta' zoledronic acid (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 events (excluding hypercalcaemia and adjusted for prior fracture), divided by the total risk period.
Maltese: Zoledronic acid 4 mg ġie studjat ukoll fi prova double-blind, li fiha l-parteċipanti ntgħażlu b'mod każwali, ikkontrollata bi plaċebo, f'228 pazjent b'metastasi tal-għadam dokumentata minn kanċer tassider biex jiġi evalwat l-effett ta' 4 mg zoledronic acid fuq il-proporzjon tar-rata ta' każijiet relatati skeletriċi (SRE), ikkalkulat bħala n-numru totali ta' każijiet ta' SRE (bl-esklużjoni ta' iperkalċemija u aġġustat għal ksur fil-passat), u diviż bil-perjodu tar-riskju totali.
English: • Zoledronic acid medac 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Maltese: • Zoledronic acid medac 4 mg/100 ml soluzzjoni għall-infużjoni jista' jintuża immedjatament mingħajr preparazzjoni addizzjonali għal pazjenti b'funzjoni normali tal-kliewi.
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-konċentrazzjonijiet ta' zoledronic acid fil-plażma żdiedu malajr ħafna, u laħqu l-massimu tagħhom fit-tmiem tal-perjodu tal-infużjoni, segwit minn tnaqqis mgħaġel għal < 10 % tal-livell massimu wara 4 sigħat u < 1 % tal-livell massimu wara 24 siegħa, b'perjodu mtawwal sussegwenti fejn il-konċentrazzjonijiet kienu baxxi ħafna li ma jaqbżux 0.1 % tal-livell massimu qabel it-tieni infużjoni ta' zoledronic acid f'jum 28.
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 zoledronic acid dose is recommended (see also section 4.4):
Maltese: F'pazjenti b'metastasi tal-għadam li jkollhom indeboliment ħafif sa moderat tal-kliewi qabel tinbeda tterapija, li għal din il-popolazzjoni hi definita bħala CLcr 30-60 ml/min, id-doża li ġejja ta' zoledronic acid hi rrakkomandata (ara wkoll sezzjoni 4.4):
English: Zoledronic acid medac can be given to people aged 65 years and over.
Maltese: Zoledronic acid medac jista' jingħata lil nies li għandhom 65 sena jew iżjed.
English: To avoid potential incompatibilities, Zoledronic acid medac concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution or 5% glucose solution.
Maltese: Biex wieħed jevita inkompatibbiltajiet potenzjali, il-konċentrat ta' Zoledronic acid medac għandu jiġi ddilwit b'soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) jew soluzzjoni ta' glucose 5%.
English: 1 bottle of 100 ml
Maltese: Flixkun 1 ta' 100 mL
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: Studji kliniċi dwar iperkalċemija kkaġunata minn tumur (TIH) urew li l-effett ta' zoledronic acid hu kkaratterizzat minn tnaqqis fit-tneħħija ta' kalċju fis-serum u calcium urinarju.
English: What Zoledronic acid medac looks like and contents of the pack Zoledronic acid medac is supplied as a concentrate for solution for infusion in a 5 ml plastic vial made of clear, colourless plastic (cycloolefine copolymer) with rubber stopper (type I bromobutyl) and sealed with flip-off seal (aluminium and polypropylene).
Maltese: Kif jidher Zoledronic acid medac u l-kontenut tal-pakkett Zoledronic acid medac hu fornut bħala konċentrat għal soluzzjoni għall-infużjoni f'kunjett tal-plastik ta' 5 ml magħmul minn plastik ċar u bla kulur (cycloolefine copolymer) b'tapp tal-lastku (bromobutyl ta' tip I ) u ssiġillat b'siġill tal-aluminju tat-tip flip-off (aluminju u polypropylene).