FrancophonIA/ELRC3.0 huggingface dataset:
English: After one year (primary analysis) the median relative change from baseline was -76 % for Bondenza 150 mg once monthly and -67 % for ibandronic acid 2.5 mg daily.
Maltese: Wara sena (analiżi primarja) il-bidla medjana relattiva mil-linja bażi kienet -76 % għal Bondenza 150 mg darba fix-xahar u -67 % għal ibandronic acid 2.5 mg kuljum.
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 ta' 3 snin dwar ksur, MF 4411 (%, 95% CI), għall-pazjenti b'punteġġ T tal-BMD tas-sinsla lumbari taħt -2.5 fil-linja bażi.
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving Bondenza 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Maltese: Mas-sentejn, 93.5 % (p=0.004) u 86.4 % tal-pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix-xahar jew ibandronic acid 2.5 mg kuljum, rispettivament, kienu dawk li rrispondew.
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-iskla ta' 84 - 160 ml/min.
English: The tablets are supplied in blisters containing 1 or 3 tablets.
Maltese: Il-pilloli huma disponnibli f'folji li fihom pillola waħda 1 jew 3 pilloli.
English: At one year, 83.5 % (p= 0.006) of patients receiving Bondenza 150 mg once monthly and 73.9 % of patients receiving ibandronic acid 2.5 mg daily were identified as responders (defined as a decrease ≥50 % from baseline).
Maltese: Ma' l-ewwel sena, 83.5 % (p= 0.006) tal-pazjenti li kienu qed jirċievu Bondenza 150 mg darba fixxahar u 73.9 % tal-pazjenti li kienu qed jirċievu ibandronic acid 2.5 mg kuljum kienu identifikati bħala dawk li rrispondew (definit bħala tnaqqis ta' ≥50 % mil-linja bażi).
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before the first food of the day.
Maltese: M'hemmx tnaqqis sinifikanti fil-biodisponibiltà jekk ibandronic acid jittieħed 60 minuta qabel l-ewwel ikel tal-ġurnata.
English: After intravenous administration of 0.5 mg, 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, 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: Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74 % with reduction to a median inhibition of 56 % seen 28 days following the fourth dose.
Maltese: Wara t-tielet u r-raba' doża, l-inibizzjoni medjana massima 6 ijiem wara d-doża kienet ta' 74 %, bi tnaqqis għal inibizzjoni medjana ta' 56 % osservata 28 ġurnata wara r-raba' doża.
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.
Maltese: Markaturi biokimiċi tal-bidla ta' l-għadam (bħal CTX urinarju u Osteocalcin tas-serum) urew id-disinn mistenni tas-soppressjoni għal-livelli ta' qabel il-menopawża u laħqu s-soppressjoni massima f'perijodu ta' 3-6 xhur.
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: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Maltese: Effetti avversi ta' ibandronic acid fi studji tattossiċità riproduttiva fil-far kienu dawk osservati bil-bisphosphonates bħala klassi.
English: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in men and women.
Maltese: Sess Il-biodisponibiltà u l-farmakokinetika ta' ibandronic acid huma simili fl-irġiel u fin-nisa.
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: 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-vini ta' 3 mg kull 3 xhur u -62.6 % għall-kors ta' 2.5 mg orali kuljum.
English: Subjects with severe renal failure (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 għola minn individwi b'funzjoni tal-kliewi normali u t-tneħħija totali ta' ibandronic acid kienet ta' 44 ml/min.
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Maltese: Eżami dentali b'dentistrija ta' prevenzjoni xierqa għandha tiġi kkunsidrata qabel il-kura b'bisphosphonates f'pazjenti b'fatturi ta' riskju fl-istess ħin (e.ż. kanċer, kimoterapija, radjuterapija, kortikosterojdi, iġene tal-ħalq ħażina).
English: The overall proportion of patients who experienced an adverse reaction was 26.0 % and 28.6 % for Bondenza 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' Bondenza 3 mg kull 3 xhur wara sena u sentejn, rispettivament.
English: Protein binding in human plasma is approximately 85 % - 87 % (determined in vitro at therapeutic 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), u għalhekk hemm potenzjal żgħir għall-interazzjoni ma' prodotti mediċinali oħra minħabba spostament.
English: ibandronic acid 2.5 mg daily (N=294)
Maltese: ibandronic acid 2.5 mg kuljum (N=294)
English: Bondenza 150 mg film-coated tablets Ibandronic acid
Maltese: BONDENZA 150 mg pilloli miksija b'rita Ibandronic acid
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 għola minn individwi b'funzjoni tal-kliewi normali u t-tneħħija totali ta' ibandronic acid kienet ta' 44 ml/min.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Maltese: Prodotti mediċinali għall-kura ta' mard tal-għadam, bisphosphonates, kodiċi ATC:
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as sodium monohydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa mimlija għal lest b'3 ml ta' soluzzjoni fiha 3 mg ibandronic acid (bħala sodium monohydrate).
English: Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14 % and 18 % of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Maltese: Imblokkaturi ta' H2 jew inibituri tal-pompi tal-protoni Fost aktar minn 1500 pazjent imdaħħla fl-istudju BM 16549 li qabbel korsijiet ta' dożaġġ ta' ibandronic acid ta' kull xahar ma' dożaġġ ta' kuljum, 14 % u 18 % tal-pazjenti wżaw imblokkaturi ta' histamine (H2) jew inibituri tal-pompi tal-protoni wara sena u sentejn, rispettivament.
English: Bondenza, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Maltese: Bondenza, bħal bisphosphonates oħra mogħtija minn ġol-vini, jista' jikkawża tnaqqis temporanju filvaluri tal-kalċju fis-serum.
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-lifes apparenti osservati hija wiesgħa, l-half-life terminali apparenti ġeneralment hija fl-iskala ta' 10 - 72 siegħa.
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-iskla ta' 84-160 ml/min.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Maltese: Tużax din il-mediċina wara id-data ta' meta tiskadi li tidher fuq il-kartuna wara “EXP”.
English: Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Maltese: Osteonekrosi tax-xedaq kienet irrappurtata wkoll f'pazjenti b'osteoporożi li qed jirċievu bisphosphonates orali.
English: The safety profile of Bondenza is derived from controlled clinical trials and post-marketing experience .
Maltese: Il-profil tas-sigurtà ta' Bondenza huwa derivat minn provi kliniċi kkontrollati u esperjenza ta' wara ttqegħid fis-suq.
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-ġembejn totali, ta' lgħonq tal-wirk u tat-trokanter wara sena (analiżi primarja), u sentejn ta' kura (Popolazzjoni PerProtokoll) fl-istudju BM 16550.
English: Due to the limited clinical experience, Bondenza is not recommended in patients with severe renal impairment (see section 4.2 and section 4.4).
Maltese: Minħabba li lesperjenza klinika hija limitata, Bondenza mhux rakkomandat f'pazjenti b'indeboliment sever talkliewi (ara sezzjoni 4.2 u sezzjoni 4.4).
English: In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bondenza 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-menopawża b'osteoprożi (BM16550), is-sigurtà globali ta' injezzjoni ġol-vini ta' Bondenza 3 mg kull 3 xhur u ibandronic acid 2.5 mg orali kuljum intweriet li kienet simili.
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: Bondenza is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see section 4.4 and section 5.2).
Maltese: Bondenza mhux irrakkomandat għal pazjenti bi tneħħija tal-krejatinina taħt 30 ml/min minħabba esperjenza klinika limitata (ara sezzjoni 4.4 u 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-ġembejn miżjud jew miżmum (p=0.004).
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 (MF4411).
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: 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 16549.
Maltese: Tabella 2: Bidla relattiva medja mil-linja bażi fil-BMD tas-sinsla lumbari, tal-ġembejn totali, ta' lgħonq tal-wirk u tat-trokanter wara sena (analiżi primarja), u sentejn ta' kura (Popolazzjoni PerProtokoll) fl-istudju BM 16549.
English: Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6 %.
Maltese: Ilkonċentrazzjonijiet massimi osservati fil-plażma ntlaħqu fi żmien 0.5 sa 2 sigħat (medjan ta' siegħa) fi stat sajjem u l-biodisponibiltà assoluta kienet madwar 0.6%.
English: ibandronic acid 2.5 mg daily (N=977)
Maltese: Ibandronic acid 2.5 mg kuljum (N=977)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/003 1 film-coated tablet EU/1/03/266/004 3 film-coated tablets
Maltese: FIS-SUQ EU/1/03/266/003 pillola miksija b'rita
English: Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Maltese: Marda li tixbaħ lill-influwenza tinkludi avvenimenti rrappurtati bħala reazzjoni jew sintomi ta' fażi akuta inkluż mijalġja, artralġja, deni, tertir, għeja, tqalligħ, nuqqas ta' aptit, u uġigħ fl-għadam.
English: Acetylsalicylic acid and NSAIDs In a two-year study in postmenopausal women with osteoporosis (BM 16549), the incidence of upper gastrointestinal events in patients concomitantly taking acetylsalicylic acid or NSAIDs was similar in patients taking ibandronic acid 2.5 mg daily or 150 mg once monthly after one and two years.
Maltese: Fi studju ta' sentejn f'nisa wara l-menopawża b'osteoprożi (BM 16549), l-inċidenza ta' avvenimenti gastro-intestinali ta' fuq, wara sena u sentejn, f'pazjenti li qed jieħdu acetylsalicylic acid jew NSAIDs fl-istess waqt kienet simili f'pazjenti li qed jieħdu ibandronic acid 2.5 mg kuljum jew 150 mg darba fix-xahar.
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 urew 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: Due to limited clinical experience, Bondenza 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' Bondenza mhix irrakkomandata għal pazjenti bi krejatinina fis-serum 'l 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: 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, eta', 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: 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 ta' l-għadam wara sentejn u tliet snin ta' kura ta' nisa wara lmenopawża b'dożi ta' ibandronic acid 2.5 mg orali kuljum u dożi intermittenti ġol-vini sa 1 mg kull 3 xhur wriet għadam ta' kwalità normali u l-ebda indikazzjoni ta' difett fil-mineralizzazjoni.
English: How to store Bondenza
Maltese: X'fih Bondenza
English: NAME OF THE MEDICINAL PRODUCT Bondenza 150 mg film-coated tablets Ibandronic acid
Maltese: TAL-PRODOTT MEDIĊINALI Bondenza 150 mg pilloli miksija b'rita Ibandronic acid
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 ta' l-iskeletru.
English: NAME OF THE MEDICINAL PRODUCT Bondenza 3 mg solution for injection Ibandronic acid
Maltese: TAL-PRODOTT MEDIĊINALI Bondenza 3 mg soluzzjoni għall-injezzjoni Ibandronic acid
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving Bondenza 150 mg once monthly and 76.7 % of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline at one year.
Maltese: Għal BMD totali tal-ġembejn, 90.0 % (p<0.001) tal-pazjenti li kienu qed jirċievu Bondenza 150 mg darba fix-xahar u 76.7 % tal-pazjenti li kienu qed jirċievu ibandronic acid 2.5 mg kuljum kellhom żieda fil-BMD totali tal-ġembejn 'l fuq jew daqs il-linja bażi ma' l-ewwel sena.
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 filvarjazzjonijiet vixxerali (sindrome renali tal-pelvi tal-ureteru).
English: Ocular inflammation*†
Maltese: Infjammazzjoni flgħajnejn*†
English: At two years the median relative change was -68 % and -62 %, in the 150 mg monthly and 2.5 mg daily arms respectively.
Maltese: Mat-tieni sena l-bidla medjana relattiva kienet -68 % u -62 %, fil-gruppi ta' 150 mg kull xahar u 2.5 mg kuljum rispettivament.
English: There are few data available on patients of African origin.
Maltese: Ftit hemm tagħrif disponibbli dwar pazjenti ta' oriġini Afrikana.
English: Bisphosphonates (like Bondenza) may also do so.
Maltese: Bisphosphonates (bħal Bondenza) jistġħu jagħmlu dan ukoll.
English: Overdose:
Maltese: Speċjalment:
English: INFORMATION IN BRAILLE [Justification for not including Braille accepted]
Maltese: [Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata]
English: - not enough calcium and vitamin D in the diet - smoking cigarettes, or drinking too much alcohol - not enough walking or other weight-bearing exercise - a family history of osteoporosis
Maltese: - insuffiċjenza ta' kalċju u vitamina D fid-dieta - tipjip ta' sigaretti, jew xorb ta' alkoħol żejjed - mhux biżżejjed mixi jew eżerċizzju ieħor ta' rfigħ ta' piżijiet - passat mediku ta' osteoporożi fil-familja
English: Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Maltese: Dijanjosi tal-kanċer, kimoterapija, radjuterapija, koritikosterojdi u iġene orali ħażina wkoll huma meqjusa bħala fatturi ta' riskju (ara sezzjoni 4.4).
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 mg kull 3 xhur u fil-grupp ta' 2.5 mg kuljum (p=0.001).
English: The absorbed fraction of 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: Il-frazzjoni ta' ibandronic acid assorbita titneħħa miċ-ċirkolazzjoni permezz ta' assorbiment fl-għadam (stmat li huwa 40-50% f'nisa wara l-menopawża) u l-bqija jiġi eliminat mingħajr ma jinbidel millkliewi.
English: At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively.
Maltese: Mat-tieni sena, 87.1 % (p<0.001) u 70.5 %, tal-pazjenti laħqu dan il-kriterju filgruppi ta' 150 mg kull xahar u 2.5 mg kuljum rispettivament.
English: Gender Pharmacokinetics of ibandronic acid are similar in men and women.
Maltese: Sess L-farmakokinetika ta' ibandronic acid huma simili fl-irġiel u fin-nisa.
English: Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance (CLcr).
Maltese: It-tneħħija ta' ibandronic acid mill-kliewi f'pazjenti bi gradi diversi ta' indeboliment tal-kliewi hija relatata b'mod lineari mat-tneħħija tal-krejatinina (CLcr).
English: Pre-filled syringes (5 ml) made of colourless type I glass, the grey rubber plunger stopper and tip cap are made of fluororesin-laminated butyl rubber, containing 3 ml of solution for injection.
Maltese: Siringi mimlija għal-lest (5 ml) li fihom 3 ml ta' soluzzjoni għall-injezzjoni, magħmula minn ħġieġ bla kulur tat-Tip I, it-tapp tal-planġer griż tal-lasktu u l-għatu tat-tarf huma magħmula minn lastku llaminat b'fluororesin.
English: 3 mg injections and 84.7 % of patient receiving 2.5 mg oral therapy had increased or maintained lumbar spine BMD (p=0.001).
Maltese: 7 % tal-pazjenti li kienu qed jirċievu 2.5 mg ta' terapija orali kellhom BMD tas-sinsla lumbari miżjud jew miżmum (p=0.001).
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Maltese: Osteonekrosi tax-xedaq, ġeneralment assoċjata mal-qlugħ ta' sinna u/jew infezzjoni lokali (inkluż osteomijelite) kienet irrappurtata f'pazjenti bil-kanċer li qed jirċievu korsijiet ta' kura inkluż primarjament bisphosphonates mogħtija minn ġol-vini.
English: The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 1530 seconds, every three months.
Maltese: Id-doża rakkomandata ta' ibandronic acid hija ta' 3 mg, mogħtija bħala injezzjoni ġol-vini fuq medda ta' 15 - 30 sekonda, kull tliet xhur.
English: While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications.
Maltese: Filwaqt li ma kienet osservata l-ebda żjieda fir-riskju fi provi kliniċi kkontrollati, wara t-tqegħid fissuq kien hemm rapporti ta' ulċeri gastriċi u duwodenali bl-użu ta' bisphosphonate orali, xi wħud severi u b'kumplikazzjonijiet.