FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe should be injected intravenously over a period of 15 - 30 seconds.
Maltese: Ibandronic acid Accord 3 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest għandha tiġi njettata ġol-vina fuq perjodu ta' 15 - 30 sekonda.
English: Where the medicinal product is administered into an existing intravenous infusion line, the infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Maltese: Fejn il-prodott mediċinali jingħata ġo linja tal-infużjoni ġol-vina eżistenti, is-soluzzjoni għall-infużjoni għandha tiġi limitata għal isotonic saline jew soluzzjoni tal-glukosju ta' 50 mg/ml (5 %).
English: Primary efficacy endpoints
Maltese: Punti finali primarji ta l-effikaċja
English: Sodium chloride Sodium acetate trihydrate Glacial acetic acid Water for injections
Maltese: Sodium chloride Sodium acetate trihydrate Acetic acid glaċjat Ilma għall-injezzjonijiet
English: The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three-year fracture study (MF 4411).
Maltese: Is-sigurtà ta' kura orali b'ibandronic acid 2.5 mg kuljum kienet evalwata f'1251 pazjent ikkurati f'4 studji kliniċi kkontrollati bil-plaċebo, bil-maġġoranza l-kbira tal-pazjenti ġejjin mill-istudju pivitali ta' 3 snin dwar ksur (MF4411).
English: Plasma concentrations of ibandronic acid increase in a dose-proportional manner after intravenous administration of 0.5 mg to 6 mg.
Maltese: Konċentrazzjonijiet fil-plażma ta' ibandronic acid jiżdiedu b'mod proporzjonali mad-doża wara għotja ġol-vina ta' 0.5 mg sa 6 mg.
English: Ibandronic acid, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Maltese: Ibandronic acid, bħal bisphosphonates oħra mogħtija fil-vina, jista' jikkawża tnaqqis temporanju filvaluri tal-kalċju fis-serum.
English: ibandronic acid 2.5 mg daily (N=575)
Maltese: ibandronic acid 2.5 mg kuljum (N=575)
English: Ibandronic acid Accord contains sodium
Maltese: Ibandronic acid Accord fih is-sodium
English: Independent risk factors, for example, low BMD, age, the existence of previous fractures, a family history of fractures, high bone turnover and low body mass index should be considered in order to identify women at increased risk of osteoporotic fractures.
Maltese: Fatturi ta' riskju indipendenti, per eżempju, BMD baxx, età, l-eżistenza ta' ksur minn qabel, passat ta' ksur fil-familja, bidla għolja fl-għadam u indiċi tal-massa tal-ġisem baxx, għandhom jiġu kkunsidrati sabiex jiġu identifikati nisa f'riskju akbar ta' ksur osteoporotiku.
English: It contains the active substance ibandronic acid.
Maltese: Fih issustanza attiva ibandronic acid.
English: Prior to treatment with ibandronic acid the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride solution.
Maltese: Qabel it-trattament b'ibandronic acid il-pazjent għandu jiġi idratat mill-gdid biżżejjed b'soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: Influenza-like illness includes events reported as acute phase reaction or symptoms, including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, and bone pain.
Maltese: Marda li tixbah lill-influwenza tinkludi avvenimenti rrappurtati bħala reazzjoni jew sintomi ta' fażi akuta inkluż mijalġja, artralġja, deni, tertir, għeja, tqalligħ, nuqqas ta' aptit, u wġigħ fl-għadam.
English: Anaphylactic reaction/shock*†
Maltese: Reazzjoni/xokk anafilattiku*†
English: Ibandronic acid Accord belongs to a group of medicines called bisphosphonates.
Maltese: Ibandronic acid Accord jagħmel parti minn grupp ta' mediċini msejħa bisphosphonates.
English: • If you have any disturbance of mineral metabolism (such as vitamin D deficiency)
Maltese: • Jekk għandek xi disturbi fil-metaboliżmu tal-minerali (bħal defiċjenza ta' vitamina D)
English: Two year data in study BM 16550
Maltese: Tagħrif kumulattiv ta' wara sentejn fl-istudju BM 16550
English: After dilution:
Maltese: Twissijiet u prekawzjonijiet:
English: Sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
Maltese: Sodium chloride, sodium acetate trihydrate, acetic acid glaċjat u ilma għall-injezzjoni.
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 ilklassi ta' prodotti mediċinali (bisfosfonati).
English: ibandronic acid 2.5 mg daily (N=334)
Maltese: ibandronic acid 2.5 mg kuljum (N=334)
English: The primary analysis of data from study BM16550 at one year and the confirmatory analysis at 2 years demonstrated the non-inferiority of 3 mg every 3 months injection dosing regimen compared to 2.5 mg oral daily dosing regimen, in terms of mean increases in BMD at lumbar spine, total hip, femoral neck and trochanter (Table 2).
Maltese: Analiżi primarja ta' tagħrif mill-istudju BM16550 wara sena u l-analiżi ta' konferma wara sentejn wrew li kors ta' dożaġġ ta' injezzjoni ta' 3 mg kull 3 xhur mhux inferjuri meta mqabbel ma' kors ta' dożaġġ ta' 2.5 mg orali kuljum, f'termini ta' żieda medja fil-BMD tas-sinsla lumbari, tal-ġenbejn totali, tal-għonq tal-wirk u tat-trokanter (Tabella 2).
English: To avoid potential incompatibilities Ibandronic acid concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Maltese: Biex jiġu evitati inkompatabiltajiet potenzjali, ibandronic acid konċentrat għal soluzzjoni għallinfużjoni għandu jiġi dilwit biss ma' soluzzjoni ta' sodium chloride isotonika jew soluzzjoni ta' 5% glucose.
English: Daily oral treatment with ibandronic acid 2.5 mg tablets resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Maltese: Kura orali kuljum b'pilloli ibandronic acid 2.5 mg irriżultat f'żidiet progressivi fil-BMD f'postijiet vertebrali u mhux vertebrali tal-iskeletru.
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: 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' impiantazzjoni, interferenza fil-ħlas naturali (distoċja), żieda fil-varjazzjonijiet vixxerali (sindromu tal-uretru pelviku renali) u anomaliji fis-snien fil- frieħ F1 fil-firien.
English: Hypocalcaemia*
Maltese: Ipokalċimija** Ipofosfatimija
English: Ibandronic acid Accord may help lower the chances of breaking bones (fractures).
Maltese: Ibandronic acid Accord jista' jgħin inaqqas ir-riskju ta' ksur ta' għadam (fratturi).
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: Solution for injection 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
Maltese: Siringa mimlija għal-lest waħda + labra għall-injezzjoni waħda 4 siringi mimlija għal-lest + 4 labar għall-injezzjoni
English: The safety and efficacy of ibandronic acid in children and adolescents below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ibandronic acid fit-tfal u l-adolexxenti b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Maltese: Avvenimenti ta' infjammazzjoni fl-għajnejn bħal uveite, episklerite u sklerite kienu rrappurtati b'ibandronic acid.
English: Pharmaco-therapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06.
Maltese: Prodotti mediċinali għa trattament ta' mard fl-għadam, bisfosfonat, Kodiċi ATC:
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: They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome).
Maltese: Dawn jinkludu numru mnaqqas ta' siti ta' impjantazzjoni, interferenza fil-ħlas naturali (distoċija), u żjieda fil-varjazzjonijiet vixxerali (sindrome renali tal-pelvi tal-ureteru).
English: Skin disorder, ecchymosis
Maltese: Disturb filġilda, ekkimozi
English: ibandronic acid 2.5 mg daily (N=377)
Maltese: ibandronic acid 2.5 mg kuljum (N=377)
English: The histological analysis of bone biopsies after two and three years of treatment of postmenopausal women with doses of oral ibandronic acid 2.5 mg daily and intermittent intravenous doses of up to 1 mg every 3 months showed bone of normal quality and no indication of a mineralisation defect.
Maltese: L-analiżi istoloġika ta' bijopsiji tal-għadam wara sentejn u tliet snin ta' kura ta' nisa wara lmenopawsa b'dożi ta' ibandronic acid 2.5 mg orali kuljum u dożi intermittenti ġol-vina sa 1 mg kull 3 xhur uriet għadam ta' kwalità normali u l-ebda indikazzjoni ta' difett fil-mineralizzazjoni.
English: • One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Maltese: • Siringa waħda mimlija għal-lest ta' 3 ml ta' soluzzjoni fiha 3 mg ibandronic acid (bħala sodium monohydrate).
English: Total clearance of ibandronic acid is low with average values in the range 84 - 160 ml/min.
Maltese: It-tneħħija totali ta' ibandronic acid hija baxxa b'valuri medji fl-iskala ta' 84 - 160 ml/min.
English: Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
Maltese: Kull kunjett fih 6 mg ta' ibandronic acid (bħala sodium monohydrate).
English: • bruising
Maltese: • infezzjonijiet
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 kkurati b'ibandronic acid fil-vina.
English: At two years, 80.1 % and 68.8 % of patients met this criterion in the 3 mg every 3 months injection arm and the 2.5 mg daily arm (p=0.001).
Maltese: 1 % u 68.8 % tal-pazjenti laħqu dan ilkriterju fil-grupp ta' injezzjoni ta' 3 mg kull 3 xhur u fil-grupp ta' 2.5 mg kuljum (p=0.001).
English: Renal and urinary
Maltese: Ir-Renju Unit
English: Not known
Maltese: Jista'
English: It is supplied as packs containing 1, 5 or 10 vials.
Maltese: Dan jiġi f'pakketti li fihom kunjett 1, 5 jew 10 kunjetti.
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: Where Ibandronic acid Accord is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Maltese: Fejn Ibandronic acid Accord jingħata minn ġo pajp talinfużjoni ġol-vina eżistenti, l-infusat għal ġol-vina għandu jiġi ristrett għal isotonic saline jew soluzzjoni ta' 50 mg/ml (5 %) ta' glukosju.
English: Ibandronic acid 3 mg injection every 3 months Bone mineral density (BMD)
Maltese: Injezzjoni ta' ibandronic acid 3 mg kull tliet xhur Densità tal-minerali tal-għadam (BMD)
English: Clinically relevant hypocalcaemia should be corrected by intravenous administration of calcium gluconate.
Maltese: Ipokalċimija li tkun klinikament rilevanti għandha tkun ittrattatapermezz ta' amministrazzjoni ġol-vina ta' calcium gluconate.
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as 2.25 mg ibandronate sodium monohydrate).
Maltese: U KWANTITATTIVA Kunjett wieħed b'2 ml konċentrazzjoni għal soluzzjoni għall-infużjoni fih 2 mg ibandronic acid (bħala sodium monohydrate).
English: Pharmacokinetics in special clinical situations
Maltese: Farmakokinetika f'sitwazzjonijiet kliniċi speċjali
English: • kidney cyst(fluid-filled sac in the kidney)
Maltese: • ċesta fil-kliewi (borża mimlija fluwidu fil-kliewi)
English: Patients with disturbances of bone and mineral metabolism
Maltese: Pazjenti b'disturbi fil-metaboliżmu tal-għadam u tal-minerali
English: There is no relevant use of ibandronic acid in children below 18 years, and ibandronic acid was not studied in this population (see section 5.1 and 5.2).
Maltese: M'hemm l-ebda użu rilevanti ibandronic acid fi tfal ta' età inqas minn 18-il sena, u ibandronic acid ma kienx studjat f'din il-popolazzjoni (ara sezzjoni 5.1 u sezzjoni 5.2).
English: Excipients: sodium chloride, acetic acid, glacial, sodium acetate trihydrate and water for injections.
Maltese: Eċċipjenti: sodium chloride, acetic acid, glaċjali sodium acetate trihydrate u ilma għall-injezzjonijiet.
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Maltese: L-osteonekrosi tal-kanal estern tas-smigħ kienet irrapportata bil-bisfosfonati, ġeneralment assoċjata ma' terapija fit-tul.
English: Pyrexia,Influenz a-like illness**, oedema peripheral, asthenia, thirst
Maltese: Deni, marda li tixbaħ lillinfluwenza**, edima periferali, astenja, għatx
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as 6.75 mg ibandronate sodium monohydrate).
Maltese: Kunjett wieħed b'6 ml konċentrazzjoni għal soluzzjoni għall-infużjoni fih 6 mg ibandronic acid (bħala sodium monohydrate).
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Maltese: Listudju involva nisa b'età minn 55 sa 80 sena, li kienu mill-inqas 5 snin wara l-menopawsa u li kellhom BMD fis-sinsla lumbari ta' -2 sa -5
English: Method of administration For intravenous use over 15 - 30 seconds, every three months.
Maltese: Metodu ta' kif għandu jingħata Użu għal ġol-vina fuq medda ta' 15 - 30 sekonda, kull tliet xhur.
English: Atypical subtrochante ric and diaphyseal femoral fractures†
Maltese: Ksur subtrochant eric u diaphyseal mhux tipiku talgħadma talwirk †
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: Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Maltese: Ibandronic acid Accord 2 mg konċentrat għal soluzzjoni għall-infużjoni Ibandronic acid Accord 6 mg konċentrat għal soluzzjoni għall-infużjoni ibandronic acid
English: Sodium chloride Acetic acid, glacial Sodium acetate trihydrate Water for injections
Maltese: Sodium chlorideAcetic acid, glaċjali Sodium acetate trihydrate Ilma għall-injezzjonijiet
English: Do not receive Ibandronic acid Accord
Maltese: Tiħux Ibandronic acid Accord
English: There was a marked depression of urinary markers of bone resorption (pyridinoline and deoxypyridinoline) in patients treated with ibandronic acid 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'ibandronic acid li kien statistikament sinifikanti meta mqabbel mal-plaċebo.
English: (mmol/l)
Maltese: NUMRU(I)
English: For the prevention of skeletal events in patients with breast cancer and bone metastases, the Ibandronic acid Accord infusion is repeated at 3-4 week intervals.
Maltese: Għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam, linfużjoni ta' Ibandronic acid Accord hija ripetuta f'intervalli ta' 3-4 ġimgħat.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for oncology indications (see section 4.8).
Maltese: Osteonekrosi tax-xedaq (ONJ) ġiet irrappurtata b'mod rari ħafna fl-ambjent ta' wara t-tqegħid fis-suq f'pazjenti li jirċievu ibandronic acid għal indikazzjonijiet onkoloġiċi (ara sezzjoni 4.8).
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 ta' linfużjoni ta' 15-il minuta.
English: ibandronic acid 3 mg injection every 3 months (N=365)
Maltese: Injezzjoni ta' ibandronic acid 3 mg kull 3 xhur (N=365)
English: Tests for genotoxicity revealed no evidence of genetic activity for ibandronic acid.
Maltese: Testijiet għall-ġenotossiċità ma żvelaw l-ebda evidenza ta' attività ġenetika għal ibandronic acid.
English: 1 vial (2 mg/2 ml)
Maltese: 2 mg
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥ 30 u <50 ml/min) jew b'indeboliment sever tal-kliewi (CLcr <30 ml/min) li qed jiġu ttrattati għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u mard metastatiku tal-għadam għandhom jiġu segwiti r-rakkomandazzjonijiet ta' dożaġġ li ġejjin:
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as ibandronic acid (see section 4.4.)
Maltese: Każijiet ta' osteonekrosi tax-xedaq ġew irrappurtati, b'mod predominanti f'pazjenti tal-kanċer ikkurati bi prodotti mediċinali li jinibixxu l-assorbiment tal-għadam, bħal ibandronic acid (ara sezzjoni 4.4).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 6 mg/6 ml
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 6 mg/6 ml
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Maltese: U KWANTITATTIVA Siringa mimlija għal lest b'3 ml ta' soluzzjoni fiha 3 mg ibandronic acid (bħala sodium monohydrate).
English: Other medicines and Ibandronic acid Accord
Maltese: Mediċini oħra u Ibandronic acid Accord
English: For this purpose the contents of the vial are to be used as follows: - Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5 % dextrose solution and infused over at least 15 minutes.
Maltese: Skeletriċi - miżjud ma' 100 ml ta' soluzzjoni isotonika ta' sodium chloride jew 100 ml ta' soluzzjoni ta' 5% dextrose u infuż fuq mill-inqas 15-il minuta.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease 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) li qed jiġu ttrattati għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u mard metastatiku tal-għadam huwa rakkomandat aġġustament fid-doża (ara sezzjoni 4.2).
English: In order to avoid potential incompatibilities, Ibandronic acid Accord concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Maltese: Sabiex jiġu evitati inkompatibilitajiet potenzjali, Ibandronic acid Accord konċentrat għal soluzzjoni għall-infużjoni għandu jitħallat biss ma' soluzzjoni isotonika ta' sodium chloride jew ma' soluzzjoni ta' 5 % dextrose.
English: This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Maltese: Dan kien punt finali kompost li kellu l-episodji relatati ma' l-iskeletru (SREsskeletal related events) li ġejjin bħala sottokomponenti tiegħu:
English: Ibandronic acid is removed from the circulation via bone absorption (estimated to be 40 - 50 % in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Maltese: Ibandronic acid jitneħħa miċ-ċirkolazzjoni permezz ta' assorbiment fl-għadam (stmat li huwa 4050% f'nisa wara l-menopawsa) u l-bqija jiġi eliminat mingħajr ma jinbidel mill-kliewi.
English: Dosage: Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Maltese: Id-doża rrakkomandata għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam hija ta' 6 mg bħala injezzjoni ġol-vini li tingħata kull 3-4 ġimgħat.
English: Pharmacokinetics of ibandronic acid are similar in men and women.
Maltese: L-farmakokinetika ta' ibandronic acid huma simili fl-irġiel u fin-nisa.
English: While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Maltese: Waqt li qed tiġi kkurat/a, għandek iżżomm iġjene orali tajba (inkluż ħasil regolari tas-snien) u tirċievi spezzjonijiet dentali ta' rutina.
English: Number of events (per patient)
Maltese: Related Events)
English: Ibandronic acid leads to progressive net gains in bone mass and a decreased incidence of fractures through the reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.
Maltese: Ibandronic acid iwassal għal żidiet progressivi netti fil-massa tal-għadam u għalinċidenza mnaqqsa ta' ksur billi jnaqqas it-tibdil elevat tal-għadam lejn livelli ta' qabel ilmenopawsa f'nisa wara l-menopawsa.
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of ibandronic acid 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' ibandronic acid f'pazjenti ta' eta' inqas minn 18-il sena.
English: Benign skin neoplasm
Maltese: Neoplażma beninna fil-ġilda
English: Children and adolescents Ibandronic acid Accord should not be used in children and adolescents below the age of 18 years.
Maltese: Tfal u adolexxenti Ibandronic acid Accord m'għandux jintuża fi tfal jew adolexxenti ta'età inqas minn 18-il sena.
English: There are no pharmacokinetic data for ibandronic acid in patients who have hepatic impairment.
Maltese: M'hemm l-ebda informazzjoni farmakokinetika għal ibandronic acid f'pazjenti b'indeboliment epatiku.