FrancophonIA/ELRC3.0 huggingface dataset:
English: In paediatric patients with severe osteogenesis imperfecta, zoledronic acid seems to be associated with more pronounced risks for acute phase reaction, hypocalcaemia and unexplained tachycardia, in comparison to pamidronate, but this difference declined after subsequent infusions.
Maltese: F'pazjenti pedjatriċi b'osteoġenesi imperfecta severa, zoledronic acid jidher li huwa assoċjat ma' riskji jispikkaw aktar għal reazzjonijiet tal-fażi akuta, ipoklaċimija u takikardija mingħajr spjegazzjoni, meta mqabbel ma' pamidronate, iżda din id-differenza naqset wara infużjonijiet sussegwenti.
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: F'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: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 x 5 ml vial
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 1 x 5 ml kunjett
English: Zoledronic Acid Teva recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Maltese: 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid
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 konċentrat 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 renali ta' zoledronic acid ġiet korrelatata mat-tneħħija ta' kreatinina bi tneħħija renali 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: - Low blood pressure.
Maltese: − Pressjoni baxxa.
English: Zoledronic Acid Teva can be given to people aged 65 years and over.
Maltese: Zoledronic acid Teva jista' jingħata lill-persuni li għandhom 65 sena jew aktar.
English: For instructions of the dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni ta' dan il-prodott mediċinali qabel lamministrazzjoni, ara sezzjoni 6.6.
English: Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Maltese: Zoledronic acid Teva 4 mg/5 ml konċentrat sterili zoledronic acid
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 parenterali 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 ndikawx effetti fil-kliewi f'dożi ekwivalenti għal jew għola mill-ogħla dożi terapewtiċi intenzjonati għall-bniedem.
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: - Blurred vision, tearing of the eye, eye sensitivity to light.
Maltese: − Reazzjonijiet ta' sensittiità eċċessiva.
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;
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic Acid Teva is used in combination with thalidomide.
Maltese: F'pazjenti b'majeloma multipla,ir-riskju ta' disfunzjoni tal-kliewi jista' jiżdied meta Zoledronic acid Teva jintuża flimkien ma' thalidomide.
English: Skeletal morbidity rate p-value
Maltese: Rata ta' morbożità skeletrika
English: - High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation,
Maltese: − Pressjoni għolja, qtugħ ta' nifs, sturdament, ansjetà, disturb fl-irqad, disturbi fit-togħma, rogħda,
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 ta' 0.9% w/v sodium chloride jew 5% w/v soluzzjoni ta' glucose.
English: Within three days after zoledronic acid 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' zoledronic acid, 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: Important information about some of the ingredients in Zoledronic Acid Teva
Maltese: Mediċini oħra u Zoledronic acid Teva
English: 10 000 Zagreb Croatia
Maltese: PLIVA Croatia Ltd Prilaz baruna Filipovića 25 10 000 Zagreb Croatia
English: The active substance is zoledronic acid.
Maltese: X'fih Zoledronic acid Teva - Is-sustanza attiva hi zoledronic acid.
English: A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
Maltese: Parti minnhom reġgħu ħarġulhom is-sintomi meta reġgħu ingħataw zoledronic acid jew bisphosphonate ieħor.
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 gastro-intestinali, fil-fwied, fil-milsa u fil-pulmun, u fil-postijiet minn fejn ikunu ngħataw l-injezzjoniet ġol-vini.
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 randomised, double-blind u kkontrollat bi plaċebo qabbel zoledronic acid4 mg ma' plaċebo fil-prevenzjoni ta' effetti skeletriċi (SRE) f'pazjenti b'kanċer tal-prostata.
English: Figure 1: Mean changes from baseline in BPI scores.
Maltese: Figura 1: Medja tal-bidliet mil-linja bażi fil-punteġġi BPI.
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 ostejomajelitis.
English: Headache
Maltese: Uvejite
English: Zoledronic Acid Teva should only be resumed when serum creatinine returns to within 10% of baseline.
Maltese: Zoledronic acid Teva jista' jerġa jingħata meta l-kreatinina fis-serum terġa lura għal 10% tal-linja bażi.
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' żieda fil-livell ta' calcium fid-demm (livell ta' calcium fis-serum korrett għall-albumina ≥12.0 mg/dl jew 3.0 mmol/l) hija doża singola ta' 4 mg zoledronic acid.
English: Hrvatska
Maltese: Il-Kroazja
English: Pain in extremities, arthralgia, musculoskeletal pain
Maltese: Insuffiċjenza renali, ħematurja, proteinurja
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg of zoledronic acid (as monohydrate)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 4 mg zoledronic acid, (bħala monohydrate).
English: Other medicinal products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Maltese: Prodotti mediċinali oħra li fihom zoledronic acid bħala s-sustanza attiva huma disponibbli għallindikazzjonijiet ta' osteoporożi u l-kura tal-marda ta' Paget's fl-għadam.
English: Hypophosphataemia
Maltese: Edema anġjonewrotika
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 'l quddiem naqset malajr għal < 10% tal-ogħla livelli wara 4 sigħat u <1% tal-għola 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: To avoid potential incompatibilities, Zoledronic Acid Teva concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibilitajiet potenzjali, is-soluzzjoni konċentrata ta' Zoledronic acid Teva għandha tiġi ddilwita b'0.9% w/v soluzzjoni ta' sodium chloride jew b'5% w/v soluzzjoni ta' glucose.
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
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 fuq pazjenti b'żieda fil-livell tal-calcium fid-demm minħabba tumuri (TIH), il-profil ta' sigurtà fost it-tliet gruppi ttrattati (zoledronic acid 4 mg u zoledronic acid 8 mg u pamidronate) kien tal-istess mill-lat ta' tipi u severità.
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: 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 għallinsuffiċjenza renali u d-dijaliżi ġew irrapportati f'pazjenti wara d-doża tal-bidu jew wara doża waħda ta' 4 mg zoledronic acid (ara sezzjoni 4.4).
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 Teva 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, id-doża ta' Zoledronic acid Teva li ġejja hi rakkomandata (ara wkoll sezzjoni 4.4):
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with zoledronic acid.
Maltese: Barra dan, kien hemm rapporti sporadiċi ta' osteonekrożi ta' siti oħra, inklużi l-ġenbejn u l-wirk, irrappurtati l-aktar f'pazjenti adulti bil-kanċer ittrattati b'zoledronic acid.
English: Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Maltese: Luxembourg/Luxemburg Tél: +32 3 820 73 73Teva Pharma Belgium N.V./S.
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic Acid Teva therapy.
Maltese: Ġiet irrapportata osteonekrożi tal-kanal estern tas-smigħ bil-bifosfonati, prinċipalment assoċjata ma' terapija fit-tul.
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 eżaġerati meqjusin li huma relatati mal-inibizzjoni tal-kompost tal-metabolizzazzjoni tal-kalċju tal-iskeletru, li tirriżulta f'ipokalċimja ta' dawk li jkunu waslu biex jwelldu, effett tal-klassi tal-bisfosfonati, distoċja u waqfien qabel iż-żmien tal-istudju.
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: UAB "Sicor Biotech" Tel: +370 5 266 02 03
Maltese: Tel: +370 5 266 02 03
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given a single infusion of Zoledronic Acid Teva.
Maltese: - Jekk qed tiġi kkurat sabiex jitnaqqas l-ammont ta' kalċju fid-demm tiegħek, normalment tingħata biss infużjoni waħda ta' Zoledronic acid Teva.
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 talfunzjoni renali għandu jitqies.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Maltese: Każijiet ta' osteonekrożi tax-xedaq kienu rappurtati, l-aktar f'pazjenti bil-kanċer kurati bi prodotti mediċinali li jinibixxu r-resorbiment tal-għadam, bħal zoledronic acid (ara sezzjoni 4.4).
English: Zoledronic acid was well tolerated when administered subcutaneously to rats and intravenously to dogs at doses up to 0.02 mg/kg daily for 4 weeks.
Maltese: Zoledronic acid kien tollerat tajjeb meta ġie mogħti permezz ta' injezzjoni taħt il-ġilda fil-firien u ġolvini fil-klieb f'dożi mhux aktar minn 0.02 mg/kg kuljum għal erba' ġimgħat.
English: In the clinical studies, zoledronic acid 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'zoledronic acid reġgħet inbdiet biss meta l-livell ta' kreatinina kien reġa ġie lura għal 10% tal-valur tal-linja bażi (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Teva 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Maltese: Informazzjoni gall-utent Zoledronic acid Teva 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni zoledronic acid
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
English: Instructions for preparing reduced doses of Zoledronic Acid Teva Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose - 4.1 ml for 3.3 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 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 ndikawx li għandu potenzjal karċinoġeniku.
English: Zoledronic Acid Teva 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 Teva mhux rakkomandat għall-pazjenti li jkollhom indeboliment sever talkliewi qabel tibda t-terapija, li għal din il-popolazzjoni hi meqjusa bħala CLcr <30 ml/min.
English: Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Maltese: Popolazzjoni pedjatrika Riżultati ta' prova klinika fil-kura ta' osteoġenesi imperfecta severa f'pazjenti pedjatriċi mill-età ta'
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 biotrasformazzjoni, 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 filfarmakokinetiċi ta' zoledronic acid.
English: The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Maltese: Iż-żmien ta' meta tibda huwa ≤3 ijiem wara l-infużjoni ta' zoledronic acid, u r-reazzjoni hija wkoll magħrufa bit-termini ta' sintomi “li jixbħu l-influwenza” jew “ta' wara d-doża”.
English: When initiating treatment with Zoledronic Acid Teva in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Maltese: Meta tkun ser tibda l-kura b'Zoledronic acid Teva f'pazjenti b'majeloma multipla jew ġrieħi ta' metastasi fl-għadam minn tumuri solidi, il-kreatinina fis-serum u t-tneħħija tal-krejatinina (CLcr) għandhom jiġu determinati.
English: Additional information on handling on Zoledronic Acid Teva, including guidance on preparation of reduced doses, is provided in section 4.2.
Maltese: Informazzjoni addizzjonali dwar il-maniġġ ta' Zoledronic acid Teva, li tinkludi gwida dwar ilpreparazzjoni ta' dożi mnaqqsa u, hija pprovduta fis-sezzjoni 4.2.
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: - Aminoglycosides (mediċini li jintużaw għall-kura ta' infezzjonijiet severi), calcitonin(tip ta' mediċina użata biex tikkura l-osteoporożiwara l-menopawsa uiperkalċimija), dijuretiċiloop(tip ta' mediċina biex tikkurapressjoni għoljajewedima) jewmediċini oħrali jbaxxul-kalċju,minħabba li meta jingħataw flimkien ma' bisfosfonati jistgħu jniżżlu l-livell ta' calcium fid-demm għal wieħed baxx wisq.
English: How to prepare and administer Zoledronic Acid Teva - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Teva concentrate (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Maltese: Kif tipprepara u tagħti Zoledronic acid Teva - Biex tipprepara soluzzjoni għall-infużjoni ta' 4 mg ta' zoledronic acid, żid il-konċentrat ta' Zoledronic acid Teva (5 ml) ma' 100 ml ta' soluzzjoni għall-infużjoni ħielsa mill-calcium jew minn soluzzjonijiet li jkun fihom divalent cations oħrajn.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Maltese: Deni, sindrome li tixbah l-influwenza (inklużi għejja, tertir, tħossok marid u ssir ruxxan)
English: United Kingdom Teva UK Limited Tel: +44 1977 628 500 This leaflet was last revised in {MM/YYYY} Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Warnings and precautions Talk to your doctor before you are given Zoledronic Acid Teva: - if you have or have had a kidney problem.
Maltese: Twissijiet u prekawzjonijiet Kellem lit-tabib tiegħek qabel ma tingħata Zoledronic acid Teva - jekk għandek jew qatt kellek problema fil-kliewi.
English: Pyrexia, fatigue
Maltese: Reazzjoni ta' fażi akuta
English: Nasopharyngitis
Maltese: Ipokalċemija
English: While being treated with Zoledronic Acid Teva, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Maltese: Waqt it-trattament b'Zoledronic Acid Teva, għandek iżżomm iġjene tajba fil-ħalq (inkluż billi taħsel snienek regolarment) u tagħmel check-ups tas-snien regolari.
English: The response rate in these patients was about 52%.
Maltese: Ir-rata ta' rispons f'dawn il pazjenti kienet ta' madwar 52%.
English: 6.6 Special precautions for disposal and other handling Prior to administration, 5 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 (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Maltese: Qabel l-għoti, 5 ml konċentrat minn kunjett wieħed jew il-volum ta' konċentrat miġbud kif meħtieġ għandu jiġi dilwit aktar b'100 ml ta' soluzzjoni għall-infużjoni li ma jkunx fiha calcium (0.9% w/v soluzzjoni ta' sodium chloride jew 5% w/v soluzzjoni ta' glucose).
English: - Do not use Zoledronic Acid Teva after the expiry date stated on the vial and carton after EXP.
Maltese: - Tużax Zoledronic acid Teva wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara
English: How to store Zoledronic Acid Teva Contents of the pack and other information
Maltese: Kif taħżen Zoledronic acid Teva Kontenut tal-pakkett u informazzjoni oħra
English: Common (may affect up to 1 in 10 people): - 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: To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibilitajiet, is-soluzzjoni ghallinfużjoni għandha tigi ddilwita b' 0.9% w/v sodium chloride jew 5% w/v soluzzjoni ta' glucose.
English: The treatment effects were less pronounced in patients with blastic lesions.
Maltese: L-effetti tal-kura kienu inqas f'pazjenti li kellhom leżjonijiet blastiċi.
English: November 2017
Maltese: Novembru 2017