FrancophonIA/ELRC3.0 huggingface dataset:
English: One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Maltese: Kunjett wieħed b'5 ml konċentrat fih 4 mg zoledronic acid (bħala monoidrat).
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: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Maltese: Tabella 3: Riżultati ta' effikaċja (pazjenti b'tumuri solidi oħra barra dawk tas-sider u tal-prostata)
English: Zoledronic Acid Hospira 4 mg/100 ml (to appear in roundel) solution for infusion Zoledronic acid
Maltese: Zoledronic Acid Hospira 4 mg/5 ml (biex jidher fir-roundel) soluzzjoni għall-infużjoni Zoledronic acid
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Hospira - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
Maltese: Huwa rrakkomandat li ssir eżaminazzjoni dentali b'dentistrija preventiva u stima tal-benefiċċju/riskju individwali qabel jibda jingħata trattament b'Zoledronic Acid Hospira f'pazjenti li jkollhom fatturi ta' riskju konkomitanti.
English: Caution is indicated when zoledronic acid is administered in conjunction with medicinal products that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration) (see section 4.4).
Maltese: Għandha tingħata attenzjoni meta zoledronic acid jingħata ma' prodotti mediċinali li jista' jkollhom impatt sinifikanti fuq il-funzjoni renali (eż. aminoglycosides jew dijuretiċi li jikkawżaw deidrazzjoni) (ara sezzjoni 4.4).
English: Dystocia was observed at the lowest dose (0.01 mg/kg bodyweight) tested in the rat.
Maltese: Tbatija tal-ħlas kienet osservata bl-aktar doża baxxa (0.01 mg/kg piż tal ġisem) eżaminata fil-firien.
English: Pack size
Maltese: Mhux komuni
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 iwelldu, effett tal-klassi tal-bisfosfonati, distoċja u waqfien qabel iż-żmien tal-istudju.
English: Zoledronic Acid Hospira (5 mg in 100 ml ready-to-infuse solution) is administered via an infusion line and given at a constant infusion rate.
Maltese: Zoledronic Acid Hospira (5 mg f'100 ml soluzzjoni lesta biex tintuża għall-infużjoni) tingħata minn pajp tal-infuzjoni u b'rata tal-infużjoni fissa.
English: INSTRUCTIONS ON USE
Maltese: MA Mhux Applikabbli
English: 6 ml, type I clear glass vial or 5 ml plastic vial, stoppered with a fluoropolymer-coated halo-butyl closure and sealed with an aluminium seal and flip-off top.
Maltese: Kunjett ta' 6 ml ta' ħġieġ ċar ta' tip I jew kunjett tal-plastik ta' 5 ml, b'għatu li jikkonsisti minn tapp tal-halobutyl miksi bil-fluoropolymer u ssiġillat b'siġill tal-aluminju li jista' jinqala' bis-saba'
English: The infusion will take at least 15 minutes.
Maltese: L-infużjoni tieħu mill-anqas 15-il minuta.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving zoledronic acid for osteoporosis.
Maltese: Osteonekrożi tax-xedaq (ONJ-osteonecrosis of the jaw) kienet irrappurtata b'mod mhux komuni fi provi kliniċi u fl-ambjent ta' wara t-tqegħid fis-suq f'pazjenti li kienu qed jirċievu zoledronic acid.
English: The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Maltese: Id-doża rakkomandata hija ta' infużjoni waħda fil-vini ta' 5 mg zoledronic acid.
English: One bag with 100 ml contains 4 mg zoledronic acid (as monohydrate).
Maltese: Borża waħda ta'100 ml fiha 4 mg zoledronic acid (bħala monoidrat).
English: All patients received adequate supplementation with vitamin D and calcium in the post-menopausal osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget's disease trials (see also section 4.2).
Maltese: Il-pazjenti kollha rċevew supplimenti xierqa ta' vitamina D u kalċju fil-prova dwar l-osteoporożi wara l-menopawża, fil-prevenzjoni tal-ksur kliniku wara prova dwar il-ksur fil-ġenbejn, kif ukoll fil-provi dwar il-marda ta' Paget (ara wkoll sezzjoni 4.2).
English: This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
Maltese: Dan hu l-aktar importanti għall-pazjenti li jieħdu d-dijuretiċi (“pilloli tal-ilma”) u għall-pazjenti anzjani.
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: Ġiet irraportata osteonekrożi tal-kanal estern tas-smigħ bil-bifosfonati, prinċipalment assoċjata ma' terapija fit-tul.
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 ġol-vini fil-klieb f'dożi mhux aktar minn 0.02 mg/kg kuljum għal erba' ġimgħat.
English: Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), the majority of whom received a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Maltese: Disfunzjoni renali kienet osservata wara li ngħata zoledronic acid, l-aktar f'pazjenti li kellhom disfunzjoni tal-kliewi minn qabel jew li kellhom xi fatturi ta' riskji oħrajn (eż. età avvanzata, pazjenti tal-onkoloġija fuq kimoterapija, l-użu konkomitanti ta' prodotti mediċinali nefrotossiċi fl-istess waqt, terapija djuretika konkomitanti, deidrazzjoni severa), li l-parti l-kbira tagħhom irċevew doża ta' 4 mg kull 3-4 ġimgħat, iżda dehret f'pazjenti wara doża waħda.
English: The active substance in Zoledronic Acid Hospira is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Maltese: Is-sustanza attiva f'Zoledronic Acid Hospira hija zoledronic acid li jagħmel parti minn grupp ta' sustanzi li jissejħu bisphosphonates.
English: In the clinical trials, renal deterioration was defined as follows:
Maltese: Fil-provi kliniċi d-deterjorament tal-funzjoni tal-kliewi ġiet definita hekk:
English: The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
Maltese: Il-possibilità ta' osteonekrożi tal-kanal estern tas-smigħ għandha tiġi kkunsidrata f'pazjenti li qegħdin jirċievu bifosfonati li jkollhom sintomi fil-widnejn inklużi infezzjonijiet kroniċi tal-widna.
English: 90 (3 x 30) tablets
Maltese: Flixkun (HDPE) 90 (3 x 30) pillola
English: 30 tablets
Maltese: Flixkun (HDPE) 30 pillola
English: (Invented) name
Maltese: (ivvintat)
English: Pack size
Maltese: Mnejn għandu Il-pakkett li
English: Strength Pharmaceutical Form
Maltese: farmaċewtika jingħata jmiss malprodott
English: EU Number
Maltese: Numru tal-EU Isem Qawwa Għamla
English: Very rare adverse reactions:
Maltese: Reazzjonijiet avversi rari ħafna:
English: Liquid paraffin: 18.2 mg
Maltese: Paraffina likwida: 18.2 mg
English: Benzyl alcohol Liquid paraffin Sorbitan monooleate Polysorbate 80
Maltese: Benzyl alcohol Paraffin likwidu Sorbitan monooleate Polysorbate 80
English: 17170 Amer (Girona) SPAIN
Maltese: 17170- AMER (Girona) SPANJA
English: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain
Maltese: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spanja