FrancophonIA/ELRC3.0 huggingface dataset:
English: • Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) syndromes: ◦ Information that only one course of treatment is proposed for NTDT patients ◦ A warning on the necessity of closer monitoring of liver iron concentration and serum ferritin in the paediatric population ◦ A warning on the currently unknown safety consequences of long-term treatment in the paediatric population
Maltese: ◦ Informazzjoni li kors ta' trattament wieħed biss hu propost għal pazjenti b'NTDT ◦ Twissija dwar il-ħtieġa ta' monitoraġġ aktar mill-qrib tal-konċentrazzjoni ta' ħadid filfwied u ta' ferritin fis-serum fil-popolazzjoni pedjatrika
English: In patients treated with doses greater than 21 mg/kg, dose reductions in steps of 3.5 to 7 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time).
Maltese: F'pazjenti kkurati b'dożi ogħla minn 21 mg/kg, tnaqqis fid-doża fi stadji ta' 3.5 sa 7 mg/kg għandu jiġi kkunsidrat meta jinkiseb kontroll (eż. livelli ta' ferritin fis-serum jibqgħu taħt 2,500 µg/l u jidhru li qed jonqsu maż-żmien).
English: Deferasirox Mylan 180 mg film-coated tablets deferasirox
Maltese: Deferasirox Mylan 180 mg pilloli miksija b'rita deferasirox
English: In post-marketing reports, a high proportion of cases of metabolic acidosis occurred in children in the context of Fanconi syndrome.
Maltese: Fir-rapporti ta' wara ttqegħid fis-suq, seħħ proporzjon għoli ta' każijiet ta' aċidożi metabolika fit-tfal fil-kuntest tas-sindrome Fanconi.
English: For deferasirox film-coated tablets, a dose ratio of 3:1 can be considered (i.e. a dose of deferasirox film-coated tablets that is numerically one third of the deferoxamine dose).
Maltese: Għal deferasirox pilloli miksija b'rita, jista' jiġi kkunsidrat proporzjon tad-doża ta' 3:1 (jiġifieri. doża ta' deferasirox pilloli miksija b'rita li hija numerikament terz tad-doża ta' deferoxamine).
English: Renal excretion of deferasirox and its metabolites is minimal (8% of the dose).
Maltese: L-Leskrezzjoni ta' deferasirox u lmetaboli tiegħu permezz tal-kliewi hija minima (8% tad-doża).
English: Dose reduction or interruption may be also considered if abnormalities occur in levels of markers of renal tubular function and/or as clinically indicated:
Maltese: It-tnaqqis jew it-twaqqif tad-doża jista' wkoll jitqies jekk iseħħu anormalitajiet fil-livelli talmarkaturi tal-funzjoni tabulari tal-kliewi u/jew kif indikat klinikament:
English: Blood creatinine increased
Maltese: Proteina fl-awrina
English: Film-coated tablet (tablet)
Maltese: Pillola miksija b'rita (pillola) [Folji]
English: While no increase in renal adverse events was observed after dose escalation of deferasirox dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with film-coated tablet doses above 21 mg/kg cannot be excluded.
Maltese: Filwaqt li fi studji kliniċi ma kienu osservati lebda żidiet fil-każijiet avversi fil-kliewi wara żidiet fid-doża ta' deferasirox pilloli li jinxterdu għal dożi ogħla minn 30 mg/kg, żieda fir-riskju ta' każijiet avversi fil-kliewi b'dożi ta' pilloli miksija b'rita aktar minn 21 mg/kg ma tistax tiġi eskluża.
English: In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 7 mg/kg.
Maltese: F'pazjenti li lLIC tagħhom ma ġiex evalwat u lferritin fis-serum hu ta' ≤2000 µg/l, id-doża m'għandhiex taqbeż 7 mg/kg.
English: In addition, in patients with liver iron concentration ≥7 mg Fe/g dw with various rare anaemias or sickle cell disease, deferasirox dispersible tablets up to 20 and 30 mg/kg produced a decrease in liver iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia.
Maltese: Minbarra hekk, f'pazjenti b'konċentrazzjoni tal-ħadid fil-fwied ta' ≥7 mg Fe/g piż niexef li kellhom diversi anemiji rari jew marda tas-sickle cell, meta ngħataw sa 20 u 30 mg/kg deferasirox pilloli li jinxterdu kien hemm tnaqqis fil-konċentrazzjoni tal-ħadid fil-fwied u tal-ferritin fis-serum li jikkumpara ma' dak li nkiseb f'pazjenti b'beta-talessimja.
English: Serum creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to therapy, weekly in the first month after initiation or modification of therapy with deferasirox (including switch of formulation), and monthly thereafter.
Maltese: Kreatinina fis-serum, tneħħija tal-kreatinina (stmat bil-formula Cockcroft-Gault jew MDRD f'adulti u bil-formula Schwartz fit-tfal) u/jew livelli ta' cystatin C fil-plasma għandhom ikunu monitorati qabel it-terapija, kull ġimgħa fl-ewwel xahar wara li tibda jew tinbidel it-terapija b'EXJADE (inkluż il-bidla fil-formulazzjoni), u kull xahar minn hemm 'il quddiem.
English: • Glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria (monitor as needed).
Maltese: magnesium jew urate fis-serum, fosfat fl-awrina, amino aċidi fl-awrina (immonitorja kif meħtieġ).
English: One of the secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter.
Maltese: Wieħed mill-parametri sekondarji tal-effikaċja kien il-bidla ta' ferritin fis-serum bejn il-linja bażi u r-raba' kwart.
English: EU/1/19/1386/004 EU/1/19/1386/005
Maltese: EU/1/19/1386/005
English: Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
Maltese: In-nisa għandhom tneħħija apparenti moderatament aktar baxxa (b'17.5%) għal deferasirox meta mqabbla mal-irġiel.
English: • Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating,
Maltese: • Mard gastrointestinali, bħal dardir, rimettar, dijarea, uġigħ ta' żaqq, nefħa, stitikezza,
English: Oesophagitis
Maltese: Kull xahar
English: The pharmacokinetics of deferasirox have not been studied in patients with renal impairment.
Maltese: Il-farmakokinetika ta' deferasirox ma kinitx studjata f'pazjenti b'indeboliment tal-kliewi.
English: • The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
Maltese: • Il-bżonn għal tabella gwida li turi b'mod ċar il-figuri, qabel ma tinbeda l-kura, tal-kreatinina fisserum, it-tneħħija tal-kreatinina, proteina fl-awrina, enzimi tal-fwied, ferritin, bħal:
English: How to store Deferasirox Mylan
Maltese: X'inhu Deferasirox Mylan
English: 1, nephrolithiasis
Maltese: 1, alopeċja
English: Physicians and patients should remain alert for signs and symptoms of gastrointestinal ulceration and haemorrhage during Deferasirox Mylan therapy and promptly initiate additional evaluation and treatment if a serious gastrointestinal adverse reaction is suspected.
Maltese: Tobba u pazjenti għandhom joqogħdu attenti għal sinjali u sintomi ta' ulċerazzjoni gastrointestinali u fsada waqt terapija b'Deferasirox Mylan u jibdew mill-ewwel evalwazzjoni oħra u kura jekk reazzjoni avversa serja gastrointestinali tkun suspettata.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil tal-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Fifty-six patients under the age of 6 years participated in this pivotal study, 28 of them receiving deferasirox dispersible tablets.
Maltese: Sitta u ħamsin pazjent taħt is-6 snin ħadu sehem f'dan listudju pivitali, 28 minnhom ingħataw deferasirox pilloli li jinxterdu.
English: <7 mg Fe/g dw or ≤2,000 µg/l
Maltese: 3.5 - 7 mg/kg/jum <7 mg Fe/g dw jew ≤2,000 µg/l Doża massima 14 mg/kg/jum
English: Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/− heterozygous mice in a 6-month study.
Maltese: Deferasirox ma żiedx irriskju tal-kanċer meta ngħata lill-firien fi studju ta' sentejn u ġrieden eterożigi transġeniċi p53+/− fi studju ta' 6 xhur.
English: In patients treated with doses >21 mg/kg/day - When target is reached
Maltese: F'pazjenti ttrattati b'dożi ta' >21 mg/kg/jum - Meta tintlaħaq il mira
English: The most frequent reactions reported during chronic treatment in clinical studies conducted with deferasirox dispersible tablets in adult and paediatric patients include gastrointestinal disturbances (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash.
Maltese: L-aktar reazzjonijiet frekwenti li kienu rappurtati waqt kura kronika fi studji kliniċi li saru b'deferasirox pilloli li jinxterdu f'pazjenti adulti u pedjatriċi jinkludu disturbi gastrointestinali (l-aktar tqalligħ, rimettar, dijarea jew uġigħ addominali) u raxx tal-ġilda.
English: Hepatitis, cholelithiasis
Maltese: Tfal u adolexxenti
English: Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g dw or serum ferritin <300 µg/l), treatment should be stopped.
Maltese: Malli jintlaħaq livell sodisfaċenti ta' ħadid fil-ġisem (LIC <3 mg Fe/g dw jew il-ferritin fis-serum <300 µg/l), it-trattament għandu jitwaqqaf.
English: ≥7 mg Fe/g dw or >2,000 µg/l
Maltese: 3.5 - 7 mg/kg/jum ≥7 mg Fe/g dw jew >2,000 µg/l Tnaqqis
English: Deferasirox Mylan 360 mg film-coated tablets
Maltese: Deferasirox Mylan 360 mg pilloli miksija b'rita
English: These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).
Maltese: Dawn leffetti sekondarji huma meqjusa bħala mhux komuni (jistgħu jaffettwaw persuna f'kull 100) jew rari (jistgħu jaffettwaw persuna f'1,000).
English: It appeared from a post-hoc analysis of this study that, in the subgroup of patients with liver iron concentration ≥7 mg Fe/g dw treated with deferasirox dispersible tablets (20 and 30 mg/kg) or deferoxamine (35 to ≥50 mg/kg), the non-inferiority criteria were achieved.
Maltese: Minn analiżi li saret wara dan listudju deher li, fis-sottogrupp tal-pazjenti li kellhom konċentrazzjoni tal-ħadid fil-fwied ≥7 mg Fe/g piż niexef ikkurati b'deferasirox pilloli li jinxterdu (20 u 30 mg/kg) jew deferoxamine (35 sa ≥50 mg/kg), il-kriterji li juru li ma kienx inferjuri intlaħqu.
English: The recommended initial daily dose of Deferasirox Mylan film-coated tablets in patients with nontransfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Maltese: Id-doża inizjali ta' Deferasirox Mylan pilloli miksija b'rita irrakkomandata għal kuljum f'pazjenti b'sindromi ta' talessimja mhux dipendenti fuq trasfużjoni hi ta' 7 mg/kg tal-piż tal-ġisem.
English: For patients, already well managed on treatment with deferoxamine, a starting dose of Deferasirox Mylan film-coated tablets that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of Deferasirox Mylan film-coated tablets).
Maltese: Għall-pazjenti li jkunu sejrin tajjeb bil-kura ta' deferoxamine, id-doża tal-bidu ta' Deferasirox Mylan pilloli miksija b'rita li tiġi numerikament terz dik ta' deferoxamine għandha tkun ikkunsidrata (eż. pazjent li qed jirċievi 40 mg/kg/jum ta' deferoxamine għal 5 ijiem fil-ġimgħa (jew ekwivalenti), jista' jinqaleb għal doża tal-bidu ta' 14 mg/kg/jum ta' Deferasirox Mylan pilloli miksija b'rita).
English: Deferasirox Mylan 180 mg film-coated tablets
Maltese: Deferasirox Mylan 180 mg pilloli miksija b'rita
English: Each film-coated tablet contains 360 mg deferasirox.
Maltese: Kull pillola miksija b'rita fiha 360 mg deferasirox.
English: Monthly
Maltese: TIKKETTAR
English: Doses (in mg/kg) must be calculated and rounded to the nearest whole tablet size.
Maltese: Id-dożi (f'mg/kg) għandhom jiġu kkalkulati u mogħtija sal-eqreb pillola sħiħa.
English: If serum ferritin falls consistently below 500 µg/l (in transfusional iron overload) or below 300 µg/l (in non-transfusion-dependent thalassaemia syndromes), an interruption of treatment should be considered.
Maltese: Jekk il-ferritin fis-serum jaqa' b'mod konsistenti taħt 500 µg/l (f'tagħbija żejda ta' ħadid dipendenti fuq trasfużjoni) jew taħt 300 µg/l (f'sindromi ta' talessimja mhux dipendenti fuq trasfużjoni), għandu jiġi kkunsidrat twaqqif tal-kura.
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with deferasirox.
Maltese: Tubulopatija tal-kliewi kienet irrappurtata l-biċċa lkbira fi tfal u adoloxxenti b'talassemija beta kkurati b'deferasirox.
English: Deferasirox Mylan 90 mg film-coated tablets
Maltese: Deferasirox Mylan 90 mg pilloli miksija b'rita
English: Elevations of liver transaminases have been reported.
Maltese: Kienu rrappurtati żidiet fit-transaminasi tal-fwied.
English: • Proteinuria (test should be performed prior to therapy and monthly thereafter)
Maltese: • Proteina fl-awrina (it-test għandu jsir qabel it-terapija u wara kull xahar)
English: > age appropriate ULN
Maltese: > ULN xieraq skont l-età u/jew Tnaqqis ta' <LLN
English: Description of selected adverse reactions
Maltese: 1, eritema multiforme
English: • Description of available deferasirox formulations on the market (e.g. dispersible tablets, filmcoated tablets and granules) ◦ Different posology regimen ◦ Different conditions of administration ◦ Dose conversion table when switching from one formulation to another
Maltese: • Deskrizzjoni tal-formulazzjonijiet disponibbli ta' deferasirox fis-suq (eż. pilloli li jinxterdu, pilloli miksija b'rita u granijiet)
English: The absolute bioavailability of the film-coated tablet formulation has not been determined.
Maltese: Il-bijodisponibilità assoluta tal-formulazzjoni tal-pillola miksija b'rita ma ġietx determinata.
English: In patients not adequately controlled with doses of 21 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a decreasing trend over time), doses of up to 28 mg/kg may be considered.
Maltese: F'pazjenti mhux ikkontrollati b'mod xieraq b'dożi ta' 21 mg/kg (eż. livelli ta' ferritin fis-serum ogħla minn 2,500 µg/l u li ma jidhrux li qed jonqsu maż-żmien), dożi sa 28 mg/kg jistgħu jiġu kkunsidrati.
English: • Headache
Maltese: Żjieda
English: Liver iron concentration (LIC)
Maltese: Konċentrazzjoni ta' ħadid fil-fwied (LIC)
English: Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3.
Maltese: Deferasirox jinkuraġġixxi l-eskrezzjoni tal-ħadid, l-aktar mal-ippurgar.
English: Concomitant administration of deferasirox and busulfan resulted in an increase of busulfan exposure (AUC), but the mechanism of the interaction remains unclear.
Maltese: L-għoti flimkien ta' deferasirox u busulfan wassal għal żieda tal-espożizzjoni ta' busulfan (AUC), imma l-mekkaniżmu ta' interazzjoni jibqa' mhux ċar.
English: Prior to launch of Deferasirox Mylan in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Deferasirox Mylan f'kull Stat Membru d-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAH) għandu jaqbel dwar il-kontenut u l-format tal-programm edukattiv, inkluż mal-mezz ta' komunikazzjoni, il-modalitajiet tat-tqassim, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: ◦ The need to consider renal biopsy:
Maltese: ◦ Il-bżonn li tikkunsidra bijopsija tal-kliewi:
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 2: “Monitoring your Deferasirox Mylan treatment”).
Maltese: It-tabib tiegħek ikun qed isegwi l-kundizzjoni tiegħek biex jara li lkura qed ikollha leffett mixtieq (ara wkoll sezzjoni 2: “Monitoraġġ tal-kura tiegħek b'Deferasirox Mylan”).
English: In patients whose serum ferritin level has reached the target (usually between 500 and 1,000 µg/l), dose reductions in steps of 3.5 to 7 mg/kg should be considered to maintain serum ferritin levels within the target range and to minimise the risk of overchelation.
Maltese: F'pazjenti li-livell ta' ferritin fis-serum tagħhom jilħaq il-mira (ssoltu bejn 500 and 1,000 µg/l), tnaqqis fid-doża fi stadji ta' 3.5 sa 7 mg/kg għandu jiġi kkunsidrat biex il-livelli ta' ferritin fis-serum jinżammu fil-medda tal-mira u jitnaqqas ir-riskju ta' kelazzjoni żejda.
English: It is recommended that serum ferritin be monitored every month to assess the patient's response to therapy and to minimise the risk of overchelation (see section 4.4).
Maltese: Huwa rrakkomandat li l-ferritin fis-serum jiġi ċċekkjat kull xahar sabiex jiġi evalwat ir-rispons talpazjent għat-terapija u jitnaqqas ir-riskju ta' kelazzjoni żejda (ara sezzjoni 4.4).
English: Deferasirox also comes as “dispersible” tablets.
Maltese: Deferasirox huwa disponibbli wkoll bħala pilloli “li jinxterdu”.
English: Agents that may decrease Deferasirox Mylan systemic exposure
Maltese: Aġenti li jistgħu jnaqqsu l-espożizzjoni sistemika ta' Deferasirox Mylan
English: It appeared from preclinical and clinical studies that deferasirox dispersible tablets could be as active as deferoxamine when used in a dose ratio of 2:1 (i.e. a dose of deferasirox dispersible tablets that is numerically half of the deferoxamine dose).
Maltese: Minn studji ta' qabel l-użu kliniku u studji kliniċi deher li deferasirox pilloli li jinxterdu jista' jkun attiv daqs deferoxamine meta jintuża f'proporzjon ta' doża ta' 2:1 (i.e. doża ta' deferasirox pilloli li jinxterdu li tiġi numerikament nofs dik tad-doża ta' deferoxamine).
English: Hepatobiliary disorders Common:
Maltese: Disturbi fil-fwied u fil-marrara Komuni:
English: Body weight, height and sexual development
Maltese: Wara li titnaqqas id-doża, waqqaf it-trattament, jekk Pazjenti adulti u pedjatriċi
English: The full EPAR for Zoledronic acid Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Zoledronic acid Mylan jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsijiet-u-tweġibiet here.
English: The usual dose of Zoledronic acid Mylan is one infusion of 4 mg over at least 15 minutes.
Maltese: Id-doża normali ta' Zoledronic acid Mylan hija ta' infużjoni waħda ta' 4 mg fuq perjodu ta' mill-inqas 15-il minuta.
English: Zoledronic acid Mylan is a ‘generic medicine'.
Maltese: Zoledronic acid Mylan huwa ‘mediċina ġenerika'.
English: It is available as a 4mg/5ml concentrate for a solution for infusion.
Maltese: Huwa disponibbli bħala konċentrat ta' 4mg/5ml għal soluzzjoni għal infużjoni.
English: EPAR summary for the public zoledronic acid
Maltese: Sommarju tal-EPAR għall-pubbliku zoledronic acid
English: The active substance in Zoledronic acid Mylan, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zoledronic acid Mylan, aċidu zoledroniku, hija bisfosfonat.
English: Other information about Zoledronic acid Mylan
Maltese: Informazzjoni oħra dwar Zoledronic acid Mylan
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Mylan on 23 August 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zoledronic acid Mylan fit-23 ta' Awwissu 2012.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Maltese: Dan jinkludi ksur (ksur fl-għadam), kompressjoni fixxewka tad-dahar (meta x-xewka tad-dahar tkun kompressa mill-għadam), disturbi fl-għadam li jeħtieġu r-radjuterapija (kura bir-radjazzjoni) jew intervent kirurġiku, u iperkalċemija (livelli għoljin ta' kalċju fid-demm).
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Mylan.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Zoledronic acid Mylan.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Mylan has been shown to have comparable quality and to be bioequivalent to Zometa.
Maltese: Is-CHMP kkonkluda li, f'konformità mar-rekwiżiti tal-UE, Zoledronic acid Mylan wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Zometa.
English: Zoledronic acid Mylan is a medicine that contains the active substance zoledronic acid.
Maltese: Zoledronic acid Mylan huwa mediċina li fiha s-sustanza attiva zoledronic acid.
English: The company provided data from the published literature on zoledronic acid.
Maltese: Il-kumpannija pprovdiet dejta minn kitbiet ippubblikati dwar zoledronic acid.
English: This means that Zoledronic acid Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Maltese: Dan ifisser li Zoledronic acid Mylan huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Zometa.
English: Because Zoledronic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Zoledronic acid Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza
English: What is Zoledronic acid Mylan?
Maltese: X'inhu Zoledronic acid Mylan?
English: What are the benefits and risks of Zoledronic acid Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Zoledronic acid Mylan?
English: Why has Zoledronic acid Mylan been approved?
Maltese: Għaliex ġie approvat Zoledronic acid Mylan?
English: How has Zoledronic acid Mylan been studied?
Maltese: Kif ġie studjat Zoledronic acid Mylan?
English: Zoledronic acid Mylan must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Maltese: Zoledronic acid Mylan jrid jintuża biss minn tabib li għandu esperjenza fl-użu ta' dan it-tip ta' mediċina mogħtija fil-vina.
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Maltese: Meta tintuża għall-prevenzjoni ta' kumplikazzjonijiet fl-għadam, l-infużjoni tista' tiġi ripetuta kull tlieta jew erba' ġimgħat, u l-pazjenti għandhom jieħdu supplimenti tal-kalċju u talvitamina D.
English: Annex
Maltese: Anness
English: - The educational pack must be available for distribution for both therapeutic indications prior to the launch of the new indication (prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors) in the Member State.
Maltese: - Il-pakkett edukattiv irid ikun disponibbli għad-distribuzzjoni kemm għal indikazzjonijiet terapewtiċi qabel it-tnedija tal-indikazzjoni l-ġdida (prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'fibrillazzjoni atrijali mhux valvulari b'wieħed jew aktar fatturi ta' riskju) fl-Istat Membru.