FrancophonIA/ELRC3.0 huggingface dataset:
English: In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Maltese: F'analiżi multivarjata, ma nstabx li l-età kienet fattur indipendenti ta' kwalunkwe parametru farmakokinetiku li ġie studjat.
English: EU/1/96/012/013: 10 vials
Maltese: EU/1/96/012/013: 10 kunjetti
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg Bondronat (287 patients).
Maltese: Pazjenti femminili b'kanċer tas-sider u metastasi fl-għadam ikkonfermat radjuloġikalment kienu randomised biex jirċievu plaċebo (277 pazjenta) jew 50 mg Bondronat (287 pazjenta).
English: Bondronat is indicated in adults for
Maltese: Bondronat huwa indikat fl-adulti għall
English: The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Maltese: Il-punt finali primarju tal-prova kien ir-rata tal-perjodu tal-morbidità skeletrika (SMPR - skeletal morbidity period rate).
English: • Bondronat is normally given by a doctor or other medical staff who have experience with the treatment of cancer
Maltese: • Bondronat normalment jingħata minn tabib jew minn staff mediku ieħor li għandhom esperjenza fit-trattament tal-kanċer
English: In subjects with severe renal impairment (mean estimated CLcr = 21.2 mL/min), dose-adjusted mean AUC0-24h was increased by 110% compared to healthy volunteers.
Maltese: F'individwi b'indeboliment sever tal-kliewi (CLcr medja stmata = 21.2 mL/min), l-AUC0-24h medja aġġustata għad-doża żdiedet b'110% meta mqabbel ma' voluntiera f'saħħithom.
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Maltese: M'hemmx tnaqqis sinifikattiv fil-bijodisponibilità sakemm ibandronic acid jittieħed 60 minuta qabel ikla.
English: There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Maltese: M'hemmx evidenza ta' differenzi interetniċi ta' rilevanza klinika bejn l-Asjatiċi u l-Kawkasi fiddispożizzjoni ta' ibandronic acid.
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Bondronat is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Maltese: Minħabba l-possibbiltà ta' dawn l-effetti irritanti u l-potenzjal ta' rkadar tal-marda li hemm preżenti, għandha tintuża kawtela meta Bondronat jingħata lill-pazjenti bi problemi gastrointestinali attivi tal-parti ta' fuq (eż. esofagu ta' Barrett, disfaġja, mard esofagali ieħor, gastrite, duwodenite jew ulċeri magħrufa).
English: In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
Maltese: In vivo, ibandronic acid jimpedixxi l-qerda tal-għadam stimulata b'mod sperimentali u kkawżata bilwaqfien tal-funzjoni tal-gonadi, retinojdi, tumuri jew estratti tat-tumuri.
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets.
Maltese: Prodotti u supplimenti mediċinali (inkluż il-kalċju) għandhom jiġu evitati b'mod simili qabel ma jittieħdu l-pilloli Bondronat.
English: United Kingdom
Maltese: L-Olanda
English: Manufacturer Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR United Kingdom
Maltese: Il-Manifattur Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Maltese: Bisfosfonati mogħtija b'mod orali jistgħu jikkawżaw irritazzjoni lokali tal-mukuża gastro-intestinali tal-parti ta' fuq.
English: • tooth problems
Maltese: • problemi fis-snien
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of medicinal products (bisphosphonates).
Maltese: Effetti mhux mixtieqa ta' ibandronic acid fi studji ta' tossiċità riproduttiva fil-far kienu dawk mistennija għal din il-klassi ta' prodotti mediċinali (bisfosfonati).
English: Subjects with severe renal impairment (CLcr  30 mL/min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function (CLcr ≥80 mL/min).
Maltese: Pazjenti b'indeboliment sever tal-kliewi (CLcr  30 mL/min) li kienu qed jirċievu doża orali ta' 10 mg ibandronic acid kuljum għal 21 ġurnata, kellhom konċentrazzjonijiet ogħla fil-plażma, id-doppju jew it-triplu ta' pazjenti b'funzjoni tal-kliewi normali (CLcr ≥80 mL/min).
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Maltese: Osteonekrosi tax-xedaq†** Osteonekrosi tal-kanal estern tassmigħ (reazzjoni avversa talklassi ta' bisphosphon ates)†
English: Gastrointestinal irritation
Maltese: Irritazzjoni gastro-intestinali
English: Pooled data from these studies demonstrated a significant advantage for Bondronat 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Maltese: Dejta miġbura minn dawn l-istudji wriet vantaġġ sinifikanti għal Bondronat 50 mg p.o. fuq ilplaċebo fit-tnaqqis ta' SREs imkejla permezz tal-SMPR (p=0.041).
English: The number of SREs was also significantly reduced with Bondronat 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
Maltese: In-numru ta' SREs ukoll kien imnaqqas b'mod sinifikanti b'Bondronat 6 mg u kien hemm tnaqqis ta' 40 % fir-riskju ta' SRE fuq il-plaċebo (riskju relattiv 0.6, p =0.003). Riżultati tal-effikaċja huma miġbura fil-qosor f'Tabella 2.
English: Bondronat is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Maltese: Bondronat huwa indikat fl-adulti għall-prevenzjoni ta' avvenimenti skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl-għadam li jeħtieġu r-radjuterapija jew il-kirurġija) f'pazjenti b'kanċer fis-sider u metastasi fl-għadam.
English: Albumin-corrected serum calcium (mmol/l)
Maltese: Kalċju fis-serum ikkoreġut għallalbumina (mmol/l)
English: Uncommon (may affect less than 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw inqas minn persuna waħda minn kull 100):
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), an increase in visceral variations (renal pelvis ureter syndrome) and teeth abnormalities in F1 offspring in rats.
Maltese: Dawn jinkludu numru iżgħar ta' siti ta' impjantazzjoni, interferenza fil-ħlas naturali (distoċja), żieda fil-varjazzjonijiet vixxerali (sindrome taluretru pelviku renali) u anomaliji fis-snien fil-frieħ F1 fil-firien.
English: AUTHORISATION
Maltese: Astenja
English: - Patients should not lie down for 60 minutes after taking Bondronat.
Maltese: - Il-pazjenti m'għandhomx jimteddu qabel 60 minuta wara li jieħdu Bondronat.
English: Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vialwith a bromobutyl rubber stopper).
Maltese: Bondronat huwa disponibbli f'pakketti li fihom 1, 5 jew 10 kunjetti (kunjett tal-ħġieġ ta' 6 ml tat-tip I b'għatu magħmul minn lastku bromobutyl).
English: **See further information below †Identified in post-marketing experience.
Maltese: **Ara taħt għall-aktar informazzjoni †Identifikati minn esperjenza ta' wara t-tqegħid fis-suq.
English: Haemorrage, duodenal ulcer, gastritis, dysphagia, dry mouth
Maltese: Emorraġija, ulċera duwodenali, gastrite, disfaġija, ħalq xott
English: A 15 minute infusion time has not been studied in cancer patients with CLCr <50 mL/min.
Maltese: Ħin tal-infużjoni ta' 15-il minuta ma ġiex studjat f'pazjenti tal-kanċer bi CLCr <50 mL/min.
English: Primary efficacy endpoints
Maltese: Punti finali primarji tal-effikaċja
English: This belongs to a group of medicines called bisphosphonates.
Maltese: Din tagħmel parti minn grupp ta' mediċini msejħa bisfosfonati.
English: To avoid potential incompatibilities Bondronat concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Maltese: Biex jiġu evitati inkompatibbiltajiet potenzjali Bondronat konċentrat għal soluzzjoni għall-infużjoni għandu jiġi dilwit biss ma' soluzzjoni isotonika ta' sodium chloride jew soluzzjoni ta' 5 % glucose.
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Maltese: Każijiet ta' reazzjoni/xokk anafilattiku, inkluż avvenimenti fatali, kienu irrappurati f'pazjenti ttrattati b'ibandronic acid fil-vini.
English: Bioavailability was reduced by approximately 75% when Bondronat tablets were administered 2 hours after a standard meal.
Maltese: Il-bijodisponibilità kienet imnaqqsa b'bejn wieħed u ieħor 75 % meta l-pilloli ta' Bondronat ingħataw sagħtejn wara ikla normali.
English: Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06.
Maltese: Prodotti mediċinali għat-trattament ta' mard fl-għadam, bisfosfonat, Kodiċi ATC:
English: Prior to treatment with Bondronat the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride solution.
Maltese: Qabel it-trattament b'Bondronat il-pazjent għandu jiġi idratat mill-ġdid biżżejjed b'soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: Albumin-corrected serum calcium (mg/dl)
Maltese: Kalċju fis-serum ikkoreġut għallalbumina (mg/dl)
English: • The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injections
Maltese: • Is-sustanzi l-oħra huma sodium chloride, acetic acid, sodium acetate u ilma għall-injezzjonijiet
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving Bondronat for oncology indications (see section 4.8).
Maltese: Osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw) kienet irrappurtata b'mod rari ħafna flambjent ta' wara t-tqegħid fis-suq f'pazjenti li jirċievu Bondronat għal indikazzjonijiet onkoloġiċi (ara sezzjoni 4.8).
English: Clinical studies have not shown any evidence of deterioration in renal function with long term Bondronat therapy.
Maltese: Studji kliniċi ma wrewx evidenza ta' deterjorazzjoni fil-funzjoni renali b'terapija fit-tul ta' Bondronat.
English: Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the Bondronat group compared to placebo.
Maltese: Konċentrazzjonijiet urinarji talmarkatur tal-assorbiment tal-għadam CTx (C-terminal telopeptide rilaxxat mill-kollaġen Tip I) kienu mnaqqsa b'mod sinifikattiv fil-grupp ta' Bondronat meta mqabbla mal-plaċebo.
English: A tabular summary of the secondary efficacy results is presented in Table 3.
Maltese: Sommarju f'tabella tar-riżultati sekondarji tal-effikaċja huwa ppreżentat f'Tabella 3.
English: Headache, dizziness, dysgeusia (taste perversion)
Maltese: Uġigħ ta' ras, sturdament, disġewżja (perverżjoni tat-togħma)
English: Cerebrovascular disorder, nerve root lesion, amnesia, migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia
Maltese: Disturb ċerebrovaskulari, leżjoni fl-għerq tannerv, telf talmemorja, emigranja, nevralġija, ipertonija, iperestesija, parestesija ċirkumorali, parosmija
English: In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose.
Maltese: F'pazjenti b'iperkalċimija moderata (kalċju fis-serum ikkoreġut għall-albumina <3 mmol/l jew < 12 mg/dl) 2 mg hija doża effettiva.
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products, due to displacement is unlikely.
Maltese: Lgħaqda mal-proteini fil-plażma umana hija bejn wieħed u ieħor 87 % f'konċentrazzjonijiet terapewtiċi, u għalhekk interazzjoni ma' prodotti mediċinali oħrajn minħabba spostament mhuwiex probabbli.
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Bondronat in patients less than 18 years old.
Maltese: Popolazzjoni pedjatrika (ara sezzjoni 4.2 u sezzjoni 5.1) M'hemm l-ebda tagħrif fuq l-użu ta' Bondronat f'pazjenti ta' eta' inqas minn 18-il sena.
English: The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration.
Maltese: L-assorbiment ta' ibandronic acid fil-passaġġ gastro-intestinali ta' fuq huwa mgħaġġel wara amministrazzjoni orali.
English: The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Maltese: Il-firxa osservata ta' half-lives apparenti hija wiesgħa u tiddependi fuq id-doża u s-sensittività talanalażi, iżda l-half-life terminali apparenti ġeneralment hija fil-firxa ta' 10-60 siegħa.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥30 u <50 mL/min) jew b'indeboliment sever tal-kliewi (CLcr <30 mL/min) huwa rakkomandat aġġustament fid-doża (ara sezzjoni 4.2).
English: If you have breast cancer that has spread to your bones, then the recommended dose is 3 vials (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Maltese: Jekk għandek kanċer tas-sider li nfirex fl-għadam, id-doża rakkomandata hija ta' kunjett wieħed (6 mg) kull 3-4 ġimgħat, bħala infużjoni fil-vini fuq medda ta' mill-inqas 15-il minuta.
English: Bondronat 50 mg film-coated tablets ibandronic acid
Maltese: Bondronat 50 mg pilloli miksija b'rita ibandronic acid
English: However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Maltese: Iżda, livelli bikrija fil-plażma jinżlu malajr, u jilħqu 10 % tal-valuri massimi fi żmien 3 u 8 sigħat wara amministrazzjoni ġol-vina jew orali rispettivament.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Bondronat administration.
Maltese: Waqt ittrattament, proċeduri dentali invażivi għandhom isiru biss wara konsiderazzjoni b'attenzjoni u għandhom jiġu evitati qrib ta' għoti ta' Bondronat.
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Maltese: Peress li Acetylsalicylic acid, prodotti mediċinali Anti-Infjammatorji Mhux Sterojdi (NSAIDsNonsteroidal Anti-Inflammatory medicinal products) u bisphosphonates huma assoċjati ma' irritazzjoni gastro-intestinali, għandu jkun hemm attenzjoni waqt l-għoti ta' dawn il-mediċini flimkien.
English: Ibandronic acid selectively inhibits osteoclast activity, reducing bone resorption and thereby reducing skeletal complications of the malignant disease.
Maltese: Ibandronic acid jinibixxi selettivament l-attività tal-osteoclasts, inaqqas l-assorbiment tal-għadam u b'hekk inaqqas ilkomplikazzjonijiet skeletriċi tal-marda malinna.
English: NAME OF THE MEDICINAL PRODUCT Bondronat 50 mg film-coated tablets.
Maltese: IL-PRODOTT MEDIĊINALI Bondronat 50 mg pilloli miksija b'rita.
English: As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Maltese: Bħall-bisfosfonati l-oħra, il-kilwa ġiet identifikata bħala l-organu primarju fil-mira ta' tossiċità sistemika.
English: Bondronat 50 mg film coated tablets are supplied in blisters (aluminium) containing 7 tablets, which are presented as packs containing 28 or 84 tablets.
Maltese: Il-pilloli miksija b'rita ta' Bondronat 50 mg huma fornuti f'folji (aluminju) ta' 7 pilloli, li huma preżentati bħala pakketti li fihom 28 jew 84 pillola.
English: No systemic accumulation was observed when ibandronic acid was administered intravenously once every 4 weeks for 48 weeks to patients with metastatic bone disease.
Maltese: L-ebda akkumulazzjoni sistematika ma ġiet osservata meta ibandronic acid ġie amministrat ġol-vina darba kull 4 ġimgħat għal 48 ġimgħa lillpazjenti b'mard metastatiku tal-għadam.
English: In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day.
Maltese: Fi studji dwar l-effett fuq issistema riproduttiva fuq il-firien b'għoti fil-vina, ibandronic acid naqqas l-għadd tal-isperma b'dożi ta' 0.3 u 1 mg/kg/jum u naqqas il-fertilità fl-irġiel b'1 mg/kg/jum u fin-nisa b'1.2 mg/kg/jum.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Hypocalcaemia
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: After dilution the infusion solution is stable for 24 hours at 2 °C - 8 °C (in a refrigerator)
Maltese: Wara li jiġi dilwit is-soluzzjoni għall-infużjoni hija stabbli għal 24 siegħa f'temperatura ta' 2 °C8 °C (fil-friġġ)
English: • if you cannot stand or sit upright for at least one hour (60 minutes) at a time
Maltese: • jekk ma tistax toqgħod bilwiefa jew toqgħod bilqiegħda wieqaf għal mill-inqas siegħa (60
English: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Bondronat tablets.
Maltese: Prodotti li fihom il-kalċju u ketajins mutivalenti oħra (bħal aluminju, manjesju, ħadid), inkluż il-ħalib u l-ikel, x'aktarx jinterferixxu fl-assorbiment tal-pilloli Bondronat.
English: The overall adverse event profile of ibandronic acid following the 15 minute infusion was consistent with the known safety profile over longer infusion times and no new safety concerns were identified relating to the use of a 15 minute infusion time.
Maltese: Il-profil ta' reazzjonijiet avversi totali ta' ibandronic acid wara linfużjoni ta' 15-il minuta kien konsistenti mal-profil magħruf ta' sigurtà għall-infużjonijiet fuq medda ta' ħin itwal, u ma kien identifikat l-ebda tħassib ġdid dwar is-sigurtà relatat mal-użu ta' ħin talinfużjoni ta' 15-il minuta.
English: Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Maltese: Bondronat 6 mg konċentrat għal soluzzjoni għall-infużjoni ibandronic acid
English: Bondronat 2 mg concentrate for solution for infusion ibandronic acid
Maltese: Bondronat 2 mg konċentrat għal soluzzjoni għall-infużjoni ibandronic acid
English: NAME OF THE MEDICINAL PRODUCT Bondronat 50 mg film-coated tablets ibandronic acid
Maltese: TAL-PRODOTT MEDIĊINALI Bondronat 50 mg pilloli miksija b'rita ibandronic acid
English: Therefore, it is recommended that the tablets should be taken after an overnight fast (minimum 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Maltese: Għalhekk, huwa rakkomandat li l-pilloli jittieħdu wara sawma ta' bil-lejl (minimu ta' 6 sigħat) u s-sawma trid titkompla għal mill-inqas 30 minuta wara li tkun ittieħdet id-doża (ara sezzjoni 4.2).
English: The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney.
Maltese: Il-frazzjoni assorbita ta' ibandronic acid titneħħa miċ-ċirkolazzjoni permezz ta' assorbiment millgħadam (stmata bħala 40-50 %) u l-kumplament jiġi eliminat kif inhu permezz tal-kliewi.
English: • Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours
Maltese: • Trattament ta' iperkalċimija kkawżata minn tumur - miżjud ma' 500 ml ta' soluzzjoni isotonika ta' sodium chloride jew 500 ml ta' soluzzjoni ta' 5% dextrose u infuż fuq medda ta' sagħtejn
English: Exposure to ibandronic acid in patients with various degrees of renal impairment is related to creatinine clearance (CLcr).
Maltese: Espożizzjoni għal ibandronic acid f'pazjenti bi gradi differenti ta' indeboliment tal-kliewi hija relatata mat-tneħħija tal-krejatinina (CLcr - creatinine clearance).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Maltese: U KWANTITATTIVA Kunjett wieħed b'6 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 6 mg ibandronic acid (bħala sodium monohydrate).
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Bondronat System Organ
Maltese: Tabella 1 Reazzjonijiet Avversi għall-Mediċina Irrappurtati mill-Għoti Orali ta' Bondronat Klassi tas
English: • you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
Maltese: • irċevejt trattament qabel b'bisphosphonate (użati għat-trattament jew prevenzjoni ta' disturbi fl għadam)
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Bondronat therapy.
Maltese: Pazjenti b'disturbi fil-metaboliżmu tal-għadam u tal-minerali Ipokalċimija u disturbi oħra fil-metaboliżmu tal-għadam u l-minerali għandhom jiġu trattati effettivament qabel ma tinbeda terapija b'Bondronat.
English: Mean Cmax was not increased in patients with mild renal impairment and increased by 12% in patients with moderate renal impairment.
Maltese: Cmax medja ma żdieditx f'pazjenti b'indeboliment ħafif tal-kliewi, u żdiedet bi 12 % f'pazjenti b'indeboliment moderat tal-kliewi.
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Maltese: L-aktar reazzjonijiet avversi serji rrappurtati huma reazzjoni/xokk anafilattika, ksur mhux tipiku talgħadma tal-wirk, osteonekrosi tax-xedaq, irritazzjoni gastro-intestinali, u infjammazzjoni fl-għajnejn (ara l-paragrafu “Deskrizzjoni ta' reazzjonijiet avversi magħżula” u sezzjoni 4.4).
English: • skin problems
Maltese: • problemi fil-ġilda
English: Your doctor may ask you to undergo a dental examination before starting treatment with Bondronat.
Maltese: M'hemm l-ebda informazzjoni speċifika dwar it-trattament ta' doża eċċessiva b'Bondronat.
English: - radiotherapy to bone for treatment of fractures/impending fractures - surgery to bone for treatment of fractures - vertebral fractures - non-vertebral fractures
Maltese: - radjuterapija fl-għadam għat-trattament ta' fratturi/fratturi imminenti - kirurġija fl-għadam għat-trattament ta' fratturi - fratturi vertebrali - fratturi mhux vertebrali
English: White to off-white film-coated tablets, of oblong shape engraved “L2” on one side and “IT” on the other side.
Maltese: Pilloli miksija b'rita, ta' forma tawwalija, bojod jagħtu fl-offwajt, b'inċiżjoni “L2” fuq naħa waħda u “IT” fuq in-naħa l-oħra.
English: Secondary efficacy endpoints
Maltese: Punti finali sekondarji tal-effikaċja
English: There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with Bondronat that was statistically significant compared to placebo.
Maltese: Kien hemm tnaqqis sinifikanti ta' markaturi fl-awrina ta' assorbiment tal-għadam (pyridinoline u deoxypyridinoline) f'pazjenti ttrattati b'Bondronat li kien statistikament sinifikanti meta mqabbel malplaċebo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/012/004