FrancophonIA/ELRC3.0 huggingface dataset:
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 avvenimenti (proporzjon tar-riskju=0.59, p=0.019) meta mqabbel mal-plaċebo.
English: - A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Maltese: - Disturb tal-funzjoni tal-kliewi msejjaħ sindrome Fanconi (normalment se jkun iddeterminat mit tabib tiegħek permezz ta' ċerti testijiet tal-awrina).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 4 (4 packs of 1) vials of 5 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-injezzjoni Pakkett multiplu: 4 (4 pakketti ta' 1) kunjetti ta' 5 ml
English: What Zoledronic acid Mylan contains - The active substance is zoledronic acid.
Maltese: X'fih Zoledronic acid Mylan - Is-sustanza attiva hi zoledronic acid.
English: The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Maltese: L-effetti ta' zoledronic acid mogħti ġol-vina fil-kura ta' pazjenti pedjatriċi (mill-età ta' sena sa 17-il sena) b'osteoġenesi imperfetta 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: Zoledronic acid Mylan can be given to people aged 65 years and over.
Maltese: Zoledronic acid Mylan jista' jingħata lill-persuni li għandhom 65 sena jew aktar.
English: Zoledronic acid Mylan contains sodium
Maltese: Zoledronic acid Mylan fih sodium
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 f'sezzjoni 6.1
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: Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: - Flu-like symptoms including arthritis and joint swelling.
Maltese: - Sintomi jixbħu lill-influwenza inkluż artrite u nefħa fil-ġogi.
English: Each vial contains 5 ml of concentrate.
Maltese: Kull pakkett fih 5 ml ta' konċentrat.
English: In the clinical studies, patients with serum creatinine > 400 μmol/l or > 4.5 mg/dl were excluded.
Maltese: Fl-istudji kliniċi, pazjenti li kellhom kreatinina fis-serum ta' > 400 µmol/l jew > 4.5 mg/dl kienu esklużi.
English: LIST OF EXCIPIENTS It also contains sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: TA' EĊĊIPJENTI Fih ukoll, sodium citrate, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet.
English: Contraindications
Maltese: .3. Kontraindikatazzjonijiet
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
Maltese: Fi provi kliniċi b'zoledronic acid, pazjenti b'kreatinina fis-serum ta' > 265µmol/l jew > 3.0 mg/dl kienu esklużi.
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Maltese: Astenja, edima periferali, reazzjoni fis-sit tal-injezzjoni (inklużi uġigħ, irritazzjoni, nefħa, ebusija), uġigħ fis-sider, u żieda fil-piż, reazzjoni anafilattika/xokk anafilattiku, urtikarja
English: BOX OF 10 VIALS
Maltese: KAXXA TA' 10 KUNJETTI
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Maltese: L-istabilità kimika u fiżika waqt l-użu ġiet murija għal 48 siegħa f'temperatura ta' 2°C-8°C u f'temperatura ta' 25°C wara dilwazzjoni f'soluzzjoni ta' 100 ml ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni jew soluzzjoni ta' 5% w/v glukożju (konċentrazzjoni minima ta' 3 mg/100 ml; konċentrazzjoni massima 4 mg/100 ml).
English: In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum 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),
English: - The other ingredients are: sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: - Is-sustanzi l-oħra huma: sodium citrate, sodium hydroxide, hydrochloric acid u ilma għal injezzjonijiet.
English: During post-marketing experience the following reactions have been reported (frequency rare): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).
Maltese: Mill-esperjenza ta' wara t-tqegħid fis-suq dawn il-ġrajjiet kienu rrappurtati (frekwenza rari): ksur subtrochanteric u diaphyseal mhux tipiku tal-għadma tal-wirk (reazzjoni avversa tal-klassi tal-bisfosfonat).
English: In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 μmol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 μmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
Maltese: Minħabba l-impatt potenzjali ta' zoledronic acid fuq il-funzjoni tal-kliewi, u minħabba nuqqas ta' tagħrif kliniku dwar is-sigurtà f'pazjenti b'indeboliment sever tal-kliewi (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' zoledronic acid f'pazjenti b'indeboliment sever fil-funzjoni tal-kliewi mhux irrakkomandat.
English: Zoledronic acid Mylan is supplied as packs containing 1, 4 or 10 vials or as multipacks comprising 4 packs, each containing 1 vial.
Maltese: Zoledronic acid Mylan jiġi f'pakketti ta' 1, 4 jew 10 kunjetti jew bħala pakketti multipli li fihom 4 pakketti, kull wieħed fih kunjett.
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Maltese: Osteonekrożi tal-kanal estern tas-smigħ (reazzjoni avversa għall-klassi bifosfonati) u ta' siti anatomiċi oħra inklużi l-wirk u lġenbejn.
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'ġabra ta' diversi analiżidwar is-sigurtà waqt il-provi ta' reġistrazzjoni ta' zoledronic acid għall-prevenzjoni ta' problemi skelettriċi f'pazjenti li għandhom kanċer avanzat li jinvolvi l-għadam, il-frekwenza ta' episodji avversi ta' indeboliment tal-kliewi li jistgħu jkunu relatati ma' zoledronic acid (reazzjonijiet avversi) kienet kif ġej: maeloma multipla (3.2%), kanċer tal-prostata (3.1%), kanċer tas-sider (4.3%), tumuri tal-pulmun u tumuri solidi oħrajn (3.2%).
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: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Maltese: Zoledronic acid hu kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
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 anormali ta' kreatinina (> 1.4 mg/dl jew > 124 µmol/l), żieda ta'
English: Additional information on handling of Zoledronic acid Mylan, including guidance on preparation of reduced doses, is provided in section 4.2.
Maltese: Informazzjoni addizzjonali dwar il-ġestjoni ta' Zoledronic acid Mylan, li tinkludi gwida dwar il-preparazzjoni ta' dożi mnaqqsa, hija pprovduta fis-sezzjoni 4.2.
English: BOX OF 4 VIALS
Maltese: KAXXA TA' 4 KUNJETTI
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: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001-004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/786/001-004
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 mal-effetti 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: Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Maltese: Differenzi statistikament sinifikanti huma mmarkati (*p< 0.05) għat-tqabbil bejn kura u oħra.
English: 1 vial of 5 ml 4 vials of 5 ml 10 vials of 5 ml
Maltese: 4 kunjetti ta' 5 ml
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5.
English: Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Maltese: Iż-żmien medjan biex jerġa' jogħla (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: 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 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 għall-qabel il-ksur), diviż mat-totali tal-perjodu ta' riskju.
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Maltese: - Reazzjonijiet ta' sensittiità eċċessiva.
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: 1 Reazzjonijiet avversi li seħħew bi frekwenzi < 5% kienu stmati b'mod mediku u intwera li dawn il-każijiet kienu konsistenti mal-profil ta' sigurtà stabbilit tajjeb ta' zoledronic acid (ara sezzjoni 4.8).
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: One vial contains 4 mg zoledronic acid (as monohydrate).
Maltese: Kunjett wieħed fih 4 mg zoledronic acid, (bħala monohydrate).
English: Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Maltese: Zoledronic acid Mylan 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni zoledronic acid
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic acid Mylan.
Maltese: - Jekk qed tingħata l-kura sabiex jitnaqqas l-ammont ta' kalċju fid-demm tiegħek, normalment tingħata biss infużjoni waħda ta' Zoledronic acid Mylan.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘hieles mis-sodium'.
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: Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Maltese: Studji fuq boroż tal-polyolefin (mimlijin minn qabel b'soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride jew 5% w/v soluzzjoni ta' glucose), ma wrewx inkompattibilità ma' Zoledronic acid Mylan.
English: Zoledronic acid Mylan 4 mg/5 ml 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: Zoledronic acid Mylan 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni, iddilwit aktar f'100 ml (ara sezzjoni 6.6), għandu jingħata bħala infużjoni waħda għal ġol-vini f'mhux inqas minn 15-il minuta.
English: Packs containing 1, 4 or 10 vials or multipacks containing 4 (4 cartons of 1) vials.
Maltese: Il-pakketti fihom 1. 4 jew 10 kunjetti jew pakketti multipli li fihom 4 (4 kartuniet ta'1) kunjetti.
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: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg zoledronic acid (as monohydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 4 mg zoledronic acid (bħala monohydrate).
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 tal-kalċju: taħbit irregolari tal-qalb (arritmija tal-qalb;
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 konentrat fih 4 mg zoledronic acid (bħala monohydrate).
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: - 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, ansjeta, disturb fl-irqad, disturbi fit-togħma, tregħid,
English: Warnings and precautions Talk to your doctor before you are given Zoledronic acid Mylan: - if you have or have had a kidney problem.
Maltese: Twissijiet u prekawzjonijiet Kellem lit-tabib tiegħek qabel tingħata Zoledronic acid Mylan: - jekk għandek jew qatt kellek problema fil-kliewi.
English: Zoledronic acid Mylan contains the same active substance as found in medicinal products indicated for treatment of osteoporosis and Paget´s disease of the bone.
Maltese: Zoledronic acid Mylan fih l-istess sustanza attiva li tinsab fi prodotti mediċinali għat-trattament għall-osteoporożi u l-marda ta' Paget fl-għadam.
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 tal-Brief Pain Inventory, BPI) deher mar-4 ġimgħa u ma' kull punt sussegwenti waqt l-istudju, meta mqabbel mal-plaċebo (Figura 1).
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Maltese: Ħafna minn dawn il-pazjenti kienu qed jirċievu wkoll kimoterapija u kortikosterojdi u kellhom sinjali ta' infezzjoni lokali inkluż osteomaelitis.
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: Skeletal morbidity rate 0.77 p-value
Maltese: Rata ta' morbożità skelettrika Valur-p
English: Mean changes from baseline in BPI scores.
Maltese: - Livell baxx ta' manjesju u potassju fid-demm.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Maltese: Tabella 2:Riżultati li juru l-effikaċja (pazjenti b'kanċer tal-prostata li qed jieħdu kura b'ormoni) Kwalunkwe SRE (+TIH)
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 krejatinina fis-serum < 400 µmol/l jew < 4.5 mg/dl (ara sezzjoni 4.4).
English: Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
Maltese: L-ipokalċimija hija riskju identifikat importanti b' Zoledronic acid Mylan fl-indikazzjonijiet approvati.
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 tal-kliewi ħafif għal moderat qabel tibda t-terapija, li għal din il-popolazzjoni titqies bħala CLcr 30-60 ml/min, id-doża ta' zoledronic acid li ġejja hi rrakkomandata (ara wkoll sezzjoni 4.4):
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: - Do not use Zoledronic acid Mylan after the expiry date stated on the vial and carton after EXP. - The unopened vial does not require any specific storage conditions.
Maltese: - Tużax Zoledronic acid Mylan wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara EXP.
English: Marketing Authorisation Holder Mylan S.A.S.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Mylan S.A.S.
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 d-dijaliżi ġew irrappurtati f'pazjenti wara d-doża tal-bidu jew wara doża waħda ta' 4 mg zoledronic acid (ara sezzjoni 4.4).
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Maltese: L-ammont miġbud tas-soluzzjoni rikostitwita għandu jiġi dilwit f'100 ml ta' soluzzjoni sterili għall-injezzjoni ta' 9mg/ml (0.9%) sodium chloride jew 5% w/v soluzzjoni ta' glucose.
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 għall-karċinoġeniċità ma indikawx li għandu potenzjal karċinoġeniku.
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: Angioneurotic oedema
Maltese: Osteonekrożi tax-xedaq
English: Zoledronic acid 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: Zoledronic acid 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: Radiation therapy to bone zoledronic acid 4 mg
Maltese: Plaċebo zoledronic acid 4mg