FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 ml/min) and moderate (mean estimated CLcr= 41.2 ml/min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 ml/min).
Maltese: Fil-prova klinika tal-farmakoloġija WP18551, wara l-għotia ta' doża waħda ta' 6 mg (fuq medda ta' 15-il minuta) ġol-vina, lAUC0-24 medja żdiedet b'14% u 86% rispettivament, f'individwi b'indeboliment ħafif (CLcr medja stmata =68.1 ml/min) u moderat (CLcr medja stmata =41.2 ml/min) tal-kliewi, meta mqabbla ma' voluntiera f'saħħithom (CLcr medja stmata=120 ml/min).
English: The number of SREs was also significantly reduced with ibandronic acid 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'ibandronic acid 6 mg u kien hemm tnaqqis ta' 40% fir-riskju ta' SRE fuq il-plaċebo (riskju relattiv 0.6, p =0.
English: Each pack contains 1 vial.
Maltese: Kull pakkett fih kunjett 1.
English: The incidence of clinical vertebral fractures was also significantly reduced by 49 % after 3 years (p=0.011).
Maltese: L-inċidenza ta' ksur vertebrali kliniku kienet ukoll mnaqqsa b'mod sinifikanti b'49% wara 3 snin (p=0.011).
English: The primary endpoint of the trial 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: Ibandronic acid 2.5 mg administered daily, showed a statistically significant and medically relevant reduction in the incidence of new vertebral fractures.
Maltese: Ibandronic acid 2.5 mg mogħti kuljum wera tnaqqis statistikament sinifikanti u ta' relevanza medika fl-inċidenza ta' ksur vertebrali ġdid.
English: • fluid build up and swelling (‘“lymphoedema”')
Maltese: • akkumulazzjoni ta' fluwidu u nefħa (‘limfoedima')
English: Mutagenicity/Carcinogenicity
Maltese: Mutaġeniċità/Karċinoġeniċità
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ: Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions
Maltese: Il-fatturi tar-riskju li ġejjin għandhom jiġu kkunsidrati meta ssir evalwazzjoni tar-riskju ta' pazjent li jiżviluppa ONJ: - il-qawwa tal-prodott mediċinali li jinibixxi l-assorbiment tal-għadam (riskju ogħla ta' komposti qawwija ħafna), mod ta' kif u mnejn jingħata (riskju ogħla ta' għoti b'injezzjoni) u doża kumulattiva ta' terapija tal-assorbiment tal-għadam - kanċer, kundizzjonijiet li fl-istess waqt idgħajfu l-pazjent (eż. enemija, koagulopatiji, infezzjoni), tipjip - terapiji konkomittanti: kimoterapija, inibituri anġjoġenesi, radjuterapija għar-ras u l-għonq
English: Method and route of administration
Maltese: Il-metodu u rotta tal-amministrazzjoni
English: Efficacy was evaluated in 2,928 patients.
Maltese: L-effikaċja ġiet evalwata f'2,928 pazjent.
English: Ibandronic acid intravenous injection decreased levels of serum C-telopeptide of the alpha chain of Type I collagen (CTX) within 3 - 7 days of starting treatment and decreased levels of osteocalcin within 3 months.
Maltese: Injezzjoni ġol-vina ta' ibandronic acid naqqset il-livelli ta' C-telopeptide tal-katina alpha tal-collagen tat-Tip 1 (CTX) fis-serum fi żmien 3 - 7 ijiem mill-bidu tal-kura u naqqset il-livelli ta' osteocalcin fi żmien 3 xhur.
English: Table 1 lists adverse drug reactions from the pivotal phase III studies (Treatment of tumour induced hypercalcaemia: 311 patients treated with ibandronic acid 2 mg or 4 mg; Prevention of skeletal events in patients with breast cancer and bone metastases: 152 patients treated with ibandronic acid 6 mg), and from post-marketing experience.
Maltese: Tabella 1 telenka r-reazzjonijiet avversi tal-mediċina mill-istudji pivitali ta' fażi III (Trattament ta' iperkalċimija kkawżata minn tumur: 311-il pazjent ittrattat b'ibandronic acid 2 mg jew 4 mg; Prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam: 152 pazjent ittrattat b'ibandronic acid 6 mg), u minn esperjenza ta' wara t-tqegħid fis-suq.
English: Osteonecrosis of jaw*†
Maltese: Osteonekrosi tax-xedaq*†
English: Chemical and physical in-use stability after dilution in 9 mg/ml (0.9 %) sodium chloride solution or 5% glucose solution has been demonstrated for 36 hours at 25°C and 2°C to 8°C.
Maltese: L-istabilità kimika u fiżika waqt l-użu wara dilwizzjoni f'soluzzjoni ta' 9 mg/ml (0.9 %) sodium chloride jew f'soluzzjoni ta' 5% glucose intweriet għal 36 siegħa f'25°C u f'2°C sa 8°C
English: After intravenous administration of 0.5 mg of ibandronic acid, total, renal, and non-renal clearances decreased by 67 %, 77 % and 50 %, respectively, in subjects with severe renal failure, but there was no reduction in tolerability associated with the increase in exposure.
Maltese: Wara għoti minn ġol-vina ta' 0.5 mg ta' ibandronic acid, it-tneħħija totali, renali u mhux renali naqsu b'67%, 77% u 50% rispettivament, f'individwi b'insuffiċjenza severa tal-kliewi iżda ma kien hemm l-ebda tnaqqis fit-tollerabilità assoċjata maż-żjieda fl-espożizzjoni.
English: Angioedema, Facial swelling/oedema, Urticaria
Maltese: Anġjoedima, nefħa/edima filwiċċ, Urtikarja
English: In the initial three-year, randomised, double-blind, placebo-controlled, fracture study (MF 4411), a statistically significant and medically relevant decrease in the incidence of new radiographic morphometric and clinical vertebral fractures was demonstrated (table 3).
Maltese: Fl-istudju tal-bidu, ta' tliet snin dwar il-ksur, tat-tip randomised, double-blind u kkontrollat bil-plaċebo (MF 4411), intwera tnaqqis statistikament sinifikanti u ta' relevanza medika fl-inċidenza ta' ksur vertebrali ġdid radjografiku, morfometriku u kliniku (tabella 3).
English: Paediatric population (see section 4.2 and section 5.1)
Maltese: Popolazzjoni pedjatrika (ara sezzjoni 4.2 u sezzjoni 5.1)
English: = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8
Maltese: = Kalċju fis-serum (mmol/l) - [0.02 x albumina (g/l)] + 0.8 Jew
English: In animal models ibandronic acid produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including suppression of urinary biochemical markers of bone collagen degradation (such as deoxypyridinoline, and cross-linked N-telopeptides of type I collagen (NTX)).
Maltese: F'mudelli tal-annimali ibandronic acid ipproduċa bidliet bijokimiċi li jindikaw inibizzjoni talassorbiment mill-ġdid tal-għadam li tiddependi fuq id-doża, inkluż soppressjoni ta' markaturi bijokimiċi tad-degradazzjoni tal-kollaġen tal-għadam (bħal deoxypyridinoline, u cross linked Ntelopeptides ta' kollaġen tat-tip I (NTX).
English: Albumin-corrected serum calcium (mg/dl)
Maltese: Kalċju fis-serum ikkoreġut għall-albumina (mg/dl)
English: There is limited data available on patients of African origin.
Maltese: Hemm tagħrif limitata ħafna fuq pazjenti ta' oriġini Afrikana.
English: Protein binding in human plasma is approximately 85 % - 87 % (determined in vitro at therapeutic ibandronic acid concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Maltese: It-twaħħil malproteini fil-plażma umana hija madwar 85% - 87% (determinata in vitro f'konċentrazzjonijiet terapewtiċi ta' ibandronic acid), u għalhekk hemm potenzjal żgħir għall-interazzjoni ma' prodotti mediċinali minħabba spostament.
English: Elderly population (>65 years)
Maltese: Popolazzjoni anzjana (> 65 sena)
English: 5 vials (6 mg/6 ml) 10 vials (6 mg/6 ml)
Maltese: Konċentrat għal soluzzjoni għall-infużjoni Kunjett 1 (6 mg/6 ml) 5 kunjetti (6 mg/6 ml) 10 kunjetti (6 mg/6 ml)
English: Increases at the hip compared to baseline were 2.8 % at the femoral neck, 3.4 % at the total hip, and 5.5 % at the trochanter.
Maltese: Żidiet fil-ġenbejn meta mqabbla mal-linja bażi kienu ta' 2.8% fl-għonq femorali, 3.4% fil-ġenbejn totali, u 5.5% fit-troċantru.
English: 6 mg (6 ml of concentrate for solution for infusion)
Maltese: 6 mg (6 ml ta' konċentrat għal soluzzjoni għall-infużjoni)
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'livelli medji filfirxa ta' 84-160 ml/min.
English: Table 2: Mean relative change from baseline of lumbar spine, total hip, femoral neck and trochanter BMD after one year (primary analysis) and two years of treatment (Per-Protocol Population) in study BM 16550.
Maltese: Tabella 2: Bidla relattiva medja mil-linja bażi fil-BMD tas-sinsla lumbari, tal-ġenbejn totali, tal-għonq tal-wirk u tat-trokanter wara sena (analiżi primarja), u sentejn ta' kura (Popolazzjoni Per-Protokoll) flistudju BM 16550.
English: Table 4: Results from 3 years fracture study MF 4411 (%, 95 % CI) for patients with lumbar spine BMD T-score below -2.5 at baseline
Maltese: Tabella 4: Riżultati mill-istudju fuq 3 snin dwar il-ksur, MF 4411 (%, 95% CI), għall-pazjenti b'punteġġ T tal-BMD tas-sinsla lumbari taħt -2.5 fil-linja bażi.
English: = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 Or
Maltese: = kalċju fis-serum (mmol/l) - [0.02 x albumina (g/l)] + 0.8 Jew
English: Ibandronic acid 2.5 mg daily tablets
Maltese: Pilloli ibandronic acid 2.5 mg kuljum
English: EU/1/12/798/005 1 pre-filled syringe EU/1/12/798/006 4 pre-filled syringe
Maltese: EU/1/12/798/005 siringa 1 mimlija għal-lest EU/1/12/798/006 4 siringi mimlijin għal-lest
English: Relative risk reduction of clinical vertebral fracture
Maltese: Tnaqqis relattiv tar-riskju ta' ksur vertebrali kliniku
English: In subjects with severe renal impairment (mean estimated CLcr=21.2 ml/min), doseadjusted 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: In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69 % was observed.
Maltese: Fil-popolazzjoni globali tal-pazjenti tal-istudju MF4411, ma kien osservat l-ebda tnaqqis għall-ksur mhux vertebrali, madankollu ibandronic acid kuljum deher li huwa effettiv f'sottopopolazzjoni ta' riskju għoli (punteġġ T tal-BMD tal-għonq femorali < -3.0), fejn kien osservat tnaqqis ta' 69% firriskju ta' ksur mhux vertebrali.
English: The overall proportion of patients who experienced an adverse reaction was 26.0 % and 28.6 % for ibandronic acid 3 mg injection every 3 months after one year and two years, respectively.
Maltese: Il-proporzjon globali ta' pazjenti li kellhom esperjenza ta' reazzjoni avversa, kien ta' 26.0 % u 28.6 % għall-injezzjoni ta' ibandronic acid 3 mg kull 3 xhur wara sena u sentejn, rispettivament.
English: • Ibandronic acid Accord is normally given by a doctor or other medical staff who have experience with the treatment of cancer.
Maltese: • Ibandronic acid Accord normalment jingħata minn tabib jew minn staff mediku ieħor li għandhom esperjenza fit trattament tal-kanċer
English: No statistically significant difference was attained after 1 year of treatment (p=0.056).
Maltese: L-ebda differenza statistikament sinifikanti ma ntlaħqet wara sena ta' kura (p=0.056).
English: Biochemical markers of bone turnover (such as urinary CTX and serum Osteocalcin) showed the expected pattern of suppression to premenopausal levels and reached maximum suppression within a period of 3 - 6 months of using 2.5 mg ibandronic acid daily.
Maltese: Markaturi bijokimiċi tal-bidla tal-għadam (bħal CTX urinarju u Osteocalcin tas-serum) urew id-disinn mistenni tas-soppressjoni għal-livelli ta' qabel il-menopawsa u laħqu s-soppressjoni massima f'perijodu ta' 3 - 6 xhur ta' użu ta' ibandronic acid 2.5 mg kuljum.
English: In severe cases intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, may be needed.
Maltese: F'każijiet severi jista' jkun hemm bżonn ta' infużjoni ġol-vina ta' dożi xierqa ta' calcium gluconate, potassium jew sodium phosphate, u magnesium sulfate.
English: • you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
Maltese: • qed tieħu mediċini li jissejħu kortikosterojdi (bħal prednisolone jew dexamethasone)
English: Ibandronic acid Accord contains the active substance ibandronic acid.
Maltese: Ibandronic acid Accord fih is-sustanza attiva ibandronic acid.
English: Due to the limited clinical experience, ibandronic acid is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Maltese: Minħabba li lesperjenza klinika hija limitata, ibandronic acid mhux rakkomandat f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 4.2 u sezzjoni 4.4).
English: Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.
Maltese: Tnaqqis ta' relevanza klinika fil-livelli ta' kalċju, fosfru u manjeżju fis-serum għandu jiġi kkoreġut b'għoti fil-vina ta' calcium gluconate, potassju jew sodium phosphate, u magnesium sulfate, rispettivament.
English: Very rare (may affect up to 1 in 10000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000):
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: Fi studji mhux kliniċi ġew osservati effetti biss f'esposizzjonijiet ħafna aktar eċċessivi millesposizzjoni massima umana li jindikaw ftit rilevanza għall-użu kliniku.
English: Ibandronic acid is indicated in adults for
Maltese: Ibandronic acid huwa indikat fl-adulti għall
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 jippreveni id-distruzzjoni tal-għadam indotta bl-esperimenti permezz ta' waqfien tal-funzjoni gonadali, retinojdi, tumuri jew estratti tat-tumur.
English: Subjects with severe renal impairment (CLcr less than 30 ml/min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2 - 3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/min.
Maltese: Individwi b'indeboliment sever tal-kliewi (CLcr inqas minn 30 ml/min) li rċevew għoti orali kuljum ta' 10 mg ibandronic acid għal 21 ġurnata, kellhom konċentrazzjonijiet fil-plażma 2 - 3 darbiet ogħla minn individwi b'funzjoni tal-kliewi normali u t-tneħħija totali ta' ibandronic acid kienet ta' 44 ml/min.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. ‘essentially sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) f'kull doża (3 ml), i.e. essenzjalment ‘bla sodium'.
English: Paediatric population (see section 4.2 and section 5.2).
Maltese: Popolazzjoni pedjatrika (ara sezzjoni 4.2 u sezzjoni 5
English: Ibandronic acid Accord 2 mg and 6 mg concentrate for solution for infusion (for oncology indications)
Maltese: Ibandronic acid Accord 2 mg u 6 mg konċentrat għal soluzzjoni għal infużjoni (għal indikazzjonijiet onkoloġiċi)
English: (N=974)
Maltese: Plaċebo (N=974)
English: • not enough calcium and vitamin D in the diet
Maltese: • insuffiċjenza ta' kalċju u vitamina D fid-dieta
English: A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after starting treatment with ibandronic acid 2.5 mg.
Maltese: Tnaqqis ta' sinifikanza klinika ta' 50% tal-markaturi bijokimiċi ta' assorbiment mill-ġdid tal-għadam kien osservat minn xahar wara l-bidu tal-kura b'ibandronic acid 2.5 mg.
English: Musculoskeletal and , connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg ibandronic acid (154 patients).
Maltese: Pazjenti femminili b'kanċer tas-sider u metastasifl-għadam ikkonfermat radjulogikament kienu randomised biex jirċievu l-plaċebo (158 pazjent) jew 6 mg ibandronic acid (154 pazjent).
English: As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Maltese: Bħall-bisfosfonati l-oħra, ilkilwa ġiet identifikata bħala l-organu primarju fil-mira ta' tossiċità sistemika.
English: Arthralgia, Myalgia, Musculoskeletal pain, Back pain
Maltese: Artralġja, Mijalġja, Uġigħ muskoluskeletrali, Uġigħ fiddahar
English: Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5).
Maltese: Il-pazjenti għandhom jirċievu kalċju u/jew vitamina D supplimentari (ara sezzjoni 4.4 u sezzjoni 4.5).
English: In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of ibandronic acid 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Maltese: Fl-istudju pivitali ta' sentejn f'nisa wara l-menopawsa b'osteoprożi (BM16550), is-sigurtà globali ta' injezzjoni ġol-vina ta' ibandronic acid 3 mg kull 3 xhur u ibandronic acid 2.5 mg orali kuljum intweriet li kienet simili.
English: Ibandronic acid 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, noninferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
Maltese: Fi studju ta' ħafna ċentri, double-blind, randomizzat, mhux ta' inferjorità ta' sentejn (BM 16550) ta' nisa wara l-menopawsa (1386 mara ta'età ta' 55 - 80) b'osteoporożi (punteġġ T tal-BMD tas-sinsla lumbari taħt -2.5
English: 6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with lavender flip-off cap.
Maltese: Kunjett tal-ħġieġ ta' 6 ml (tip I) bi stopper tal-ethylene tetrafluoroethylene u gomma u siġilli talaluminju b'tapp kulur il-lavandra tat-tip 'flip-off'.
English: PRE-FILLED SYRINGE
Maltese: Ġebel fil-marrara
English: The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10 - 72 hours.
Maltese: L-skala tal-half-lives apparenti osservati hija wiesgħa, l-half-life terminali apparenti ġeneralment hija fl-iskala ta' 10 - 72 siegħa.
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Maltese: Osteonekrosi tax-xedaq†** Osteonekrosi tal-kanal estern tassmigħ (reazzjoni avversa talklassi talbisfosfonat)
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: Relative Risk Reduction New morphometric vertebral fractures
Maltese: Tnaqqis relattiv tar-riskju Ksur vertebrali morfometriku ġdid Inċidenza ta' ksur vertebrali morfometriku ġdid
English: For total hip BMD, 82.3 % of patients receiving 3 mg injection every 3 months were responders at one year, compared with 75.1 % of patients receiving 2.5 mg daily orally (p=0.02).
Maltese: Għal BMD totali tal-ġenbejn, 82.3 % tal-pazjenti li kienu qed jirċievu injezzjoni ta' 3 mg kull 3 xhur kienu dawk li rripsondew wara sena, meta mqabbel ma' 75.1 % tal-pazjenti li kienu qed jirċievu 2.5 mg orali kuljum (p=0.02).
English: In addition, 64.8 % of patients receiving 3 mg every 3 months injection were identified as responders (defined as a decrease ≥ 50 % from baseline), compared with 64.9 % of patients receiving 2.5 mg daily orally.
Maltese: Barra minn hekk 64.8 % tal-pazjenti li kienu qed jirċievu injezzjoni ta' 3 mg kull 3 xhur kienu identifikati bħala dawk li rrispondew (definiti bħala tnaqqis ta' ≥50 % mil-linja bażi), meta mqabbel ma' 64.9 % tal-pazjenti li kienu qed jirċievu 2.5 mg orali kuljum.
English: A tabular summary of these secondary efficacy results is presented in Table 3.
Maltese: Sommarju f' tabella ta' dawn irriżultati sekondarji tal-effikaċja huwa ppreżentat f'Tabella 3.
English: Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats (see section 5.2).
Maltese: Interazzjonijiet metaboliċi mhux ikkunsidrati bħala probabbli peress li ibandronic acid ma jinibixxix liżoenzimi P450 maġġuri umani tal-fwied u ntwera li ma jinduċix is-sistema taċ-ċitokromju P450 talfwied fil-firien (ara sezzjoni 5.2).
English: After 2 years of treatment, 85.6 % of patients receiving 3 mg injections and 77.0 % of patient receiving 2.5 mg oral therapy had increased or maintained total hip BMD (p=0.004).
Maltese: Wara sentejn ta' kura, 85.6 % tal-pazjenti li kienu qed jirċievu injezzjonijiet ta' 3 mg u 77.0 % tal-pazjenti li kienu qed jirċievu 2.5 mg ta' terapija orali kellhom BMD totali tal-ġenbejn miżjud jew miżmum (p=0.004).
English: Due to limited clinical experience, ibandronic acid injection is not recommended for patients with a serum creatinine above 200 μmol/l (2.3 mg/dl) or with a creatinine clearance below 30 ml/min (see section 4.2 and section 5.2).
Maltese: Minħabba esperjenza klinika limitata, injezzjoni ta' ibandronic acid mhix irrakkomandata għal pazjenti bi krejatinina fis-serum 'il fuq minn 200 μmol/l (2.3 mg/dl) jew bi tneħħija tal-krejatinina taħt 30 ml/min (ara sezzjoni 4.2 u sezzjoni 5.2).
English: Ibandronic acid Accord 3 mg injection Ibandronic acid
Maltese: Ibandronic acid Accord 3 mg injezzjoni
English: The vertebral fracture risk reduction was very consistent with that seen in the overall population.
Maltese: It-tnaqqis fir-riskju ta' ksur vertebrali kien ferm konsistenti ma' dak li kien osservat fil-popolazzjoni ġenerali.
English: It is supplied as packs containing 1, 5 or 10 vials with 6 ml of concentrate.
Maltese: Jiġi f'pakketti li fihom kunjett 1, 5 jew 10 kunjetti b'6 ml ta' konċentrat.
English: At 12 months median relative changes from baseline were -58.6 % for the intravenous injection of 3 mg every 3 months regimen and -62.6 % for oral 2.5 mg daily regimen.
Maltese: Wara 12-il xahar, bidliet medjani relattivi mil-linja bażi kienu ta' -58.6 % għall-injezzjoni ġol-vina ta' 3 mg kull 3 xhur u -62.6 % għall-kors ta' 2.5 mg orali kuljum.
English: Prior to treatment with Ibandronic acid Accord the patient should be adequately rehydrated with 9 mg/ml (0.9 %) sodium chloride.
Maltese: Qabel it-trattament b'Ibandronic acid Accord il-pazjent għandu jiġi idratat mill-ġdid biżżejjed b'9 mg/ml (0.9%) sodium chloride.
English: 6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with pink flip-off cap.
Maltese: Kunjett tal-ħġieġ ta' 6 ml (tip I) bi stopper tal-ethylene tetrafluoroethylene u gomma u siġilli talaluminju b'tapp roża tat-tip 'flip-off'.