FrancophonIA/ELRC3.0 huggingface dataset:
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 medikament rilevanti fl-inċidenza ta' ksur vertebrali ġdid.
English: • The other ingredients are: tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80.
Maltese: • Is-sustanzi l-oħra huma: il-qalba tal-pillola: cellulose microcrystalline, povidone K-30, crospovidone (tip A), silica colloidal anhydrous, stearic acid; il-kisi tal-pillola: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80.
English: There was also a 38% reduction in the risk of developing an SRE for ibandronic acid treated patients when compared with placebo (relative risk 0.62, p=0.003).
Maltese: Kien hemm ukoll tnaqqis ta' 38 % fir-riskju għall-iżvilupp ta' SRE għal pazjenti trattati b'ibandronic acid meta mqabbla mal-plaċebo (riskju relattiv 0.62, p=0.003).
English: Hypersensitivi ty†, bronchospasm angioedema†, anaphylactic reaction/shock
Maltese: Sensittività eċċessiva†, bronkospażmu†, anġjoedima†, reazzjoni/xokk anafilattiku†*
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 fil-medja mill-punt ta' riferiment bażi ta' spina lumbari, ġenb totali, għonq femorali u troxanter BMD wara sena (analiżi primarja) u sentejn ta' trattament (skont il-protokoll talpopolazzjoni) (fi studju BM16549).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletrali u tat-tessut konnettiv
English: In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Maltese: F'analiżi multivarjanti, l-età ma nstabitx li hi fattur independenti ta' xi parametru farmakokinetiku li ġie studjat.
English: Incidence of clinical vertebral fracture 6.97 % (4.67, 9.27) BMD - mean change relative to baseline lumbar spine at year 3
Maltese: Inċidenza ta' ksur vertebrali kliniku 6.97 % (4.67, 9.27)
English: EU/1/10/642/003 1 film-coated tablet in PVC/Aclar/PVC - Aluminium blister in cardboard boxes EU/1/10/642/004 3 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/642/003 pillola miksija b'rita f'folji tal-aluminju PVC/Aclar-PVC f'kaxxi talkartun EU/1/10/642/004 3 pilloli miksija b'rita f'folji aluminju PVC/Aclar-PVC f'kaxxi tal-kartun
English: • The active substance is ibandronic acid.
Maltese: • Is-sustanza attiva hi ibandronic acid.
English: Paraesthesia, dysgeusia (taste perversion)
Maltese: Parasteżija, disġewżja (togħma ħażina)
English: Relative Risk Reduction New morphometric vertebral fractures
Maltese: Tnaqqis Relattiv fir-Riskju Ksur vertebrali morfometriku ġdid
English: EU/1/10/642/001 28 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes EU/1/10/642/002 84 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/642/001 28 pillola miksija b'rita f'folji tal-aluminju PVC/Aclar-PVC f'kaxxi talkartun EU/1/10/642/002 84 pillola miksija b'rita f'folji tal-aluminju PVC/Aclar-PVC f'kaxxi talkartun
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 f'livelli medji fil-frxa ta' 84-160 mL/min.
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: Iż-żidiet meta mqabbla mal-linja bażi ta' riferiment kienu ta' 2.8 %fl-għonq femorali, ,3.4 % totali fil-ġenbejn u 5.5 % at the troxanter.
English: Ibandronic acid 2.5 mg daily
Maltese: Ibandronic acid 2.5 mg kuljum
English: Osteonecrosis of jaw†*, osteonecrosis of the external auditory canal (bisphosphona te class adverse reaction)†
Maltese: Osteonekrosi taxxedaq*†, osteonekrosi talkanal estern tassmigħ (reazzjoni avversa tal-klassi ta' bisphosphonates)
English: UAB "Sicor Biotech" Eesti filiaal Tel: +372 661 0801
Maltese: UAB "Sicor Biotech" filiāle Latvijā Tel: +371 673 23 666
English: Arthralgia, Myalgia, Musculoskele tal pain, Muscle cramp,
Maltese: Artralġja, Mijalġja, Uġigħ muskoluskeletrali, Bugħawwieġ, Ebusija muskoluskeletrali
English: Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC - Aluminium) in cartons of 28 or 84 tablets.
Maltese: Ibrandronic Acid Teva jiġi fil-folji (PVC/Aclar/PVC - Aluminju) f'kartuni ta' 28 jew 84 pillola.
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: għaqda mal-proteini fil-plażma tal-bniedem hi ta' madwar 85 %-87 % (stabbiliti in vitrof'konċentrazzjonijiet terapewtiċi) u għalhekk interazzjoni bejn mediċini minħabba spostament mhuwiex probabbli.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi huma mniżżla skont is-sistema tal-klassifika tal-organi MedDRA u l-kategorija ta' frekwenza.
English: Table 1: Adverse reactions occurring in postmenopausal women receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily in the phase III studies BM 16549 and MF 4411 and in post-marketing experience.
Maltese: Tabella 1: Reazzjonijiet avversi li jseħħu f'nisa wara l-menopawsa li qed jirċievu ibandronic acid 150 mg darba fix-xahar jew ibandronic acid 2.5 mg kuljum fl-istudji BM 16549 u MF4411 u wara lesperjenza ta' wara t-tqegħid fis-suq.
English: Incidence of new morphometric vertebral fractures Relative risk reduction of clinical vertebral fracture Incidence of clinical vertebral fracture
Maltese: Tnaqqis Relattiv fir-Riskju Ksur vertebrali morfometriku ġdid Inċidenza ta' ksur vertebrali morfometriku ġdid Tnaqqis relattiv fir-riskju ta' ksur vertebrali kliniku
English: Relative risk reduction of clinical vertebral fracture
Maltese: Tnaqqis relattiv fir-riskju ta' ksur vertebrali kliniku
English: Analgesic use *
Maltese: Użu analġeżiku *
English: Efficacy was evaluated in 2,928 patients.
Maltese: Effikaċja kienet evalwata f'2,928 pazjent.
English: Elderly (see section 4.2)
Maltese: Anzjani (ara sezzjoni 4.2)
English: When taken 30 minutes before a meal, the reduction in bioavailability is approximately 30%.
Maltese: Meta jittieħed 30 minuta qabel ikla, ittnaqqis fil-bijodisponibilità hija ta' madwar 30 %.
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 konsistenti ma dak li ġie osservat fil-popolazzjoni globali.
English: Azotaemia (uraemia)
Maltese: Ażotemija (uremija)
English: Teva Pharmaceuticals CR, s.r.o.
Maltese: Česká republika Teva Pharmaceuticals CR, s.r.o.
English: Haemorrhage, duodenal ulcer, gastritis, dysphagia, dry mouth
Maltese: Emorraġija, ulċera duodenali, gastrite, disfaġija, ħalq xott
English: Ibandronic Acid Teva contains the active substance ibandronic acid.
Maltese: Ibrandronic Acid Teva fih is-sustanza attiva ibandronic acid.
English: • anaemia(bloodlessness)
Maltese: • anemija (nuqqas ta' demm)
English: As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Maltese: Bħal bisfosfonati oħra, til-kliewi kienu identifikati bħala l-organi prinċipali ta' tossiċità sistemika.
English: H2-antagonists or other medicinal products that increase gastric pH.
Maltese: Antagonisti ta' H2 jew prodotti mediċinali oħra li jżidu l-pH tal-istonku.
English: Ibandronic Acid Teva 150 mg: Medicinal product subject to medical prescription.
Maltese: Ibandronic Acid Teva 150 mg: Prodott mediċinali li jingħata bir-riċetta tat-tabib.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
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 amministrazzjoni ġol-vina ta' 0.5 mg, it-tneħħija totali, mill-kliewi u mhux mill-kliewi naqsu b'67 %, 77 % u 50 %, rispettivament, f'individwi b'indeboliment sever tal-kliewi, imma, ma kien hemm l-ebda tnaqqis fit-tollerabilità assoċjata maż-żieda fl-espożizzjoni.
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: Fuq mudelli ta' annimali ibandronic acid ipproduċa bidliet bijokimiċi li huma indikattivi ta' impediment li jiddependi mid-doża ta' assorbiment mill-ġdid tal-għadam, li jinkludi t-trażżin ta' markers bijokimiċi urinarji ta' deterjorament ta' kollaġen tal-għadam (bħal deoxypyridinoline, u Ntelopeptides inkroċjati ta' kollaġen ta' tip I (NTX)).
English: At two years 78.7 % (p=0.002) and 65.6 % of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
Maltese: Wara sentejn 78.7 % (p=0.002) u 65.6 % tal-pazjenti kienu identifikati bħala li rrispondew fid-driegħ ta' 150 mg ta' kull xahar u 2.5 mg ta' darba kuljum rispettivament.
English: Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic Acid
Maltese: Tabella 1 Reazzjonijiet Avversi tal-mediċina rrapportati għall-għoti orali ta' Ibandronic Acid
English: Gastrointestinal adverse reactions
Maltese: Reazzjonijiet gastrointestinali avversi
English: • if you cannot stand or sit upright for at least one hour (60 minutes) at a time
Maltese: • jekk ma tistax toqgħod bilwieqfa jew toqgħod bilqegħda dritta għal tal-anqas siegħa (60 minuta) fi kwalunkwe ħin
English: 747 70 Opava-Komarov Czech Republic
Maltese: Opava-Komarov Ir-Repubblika Ċeka
English: Ibandronic acid was taken 60 minutes before the first food or drink of the day (post-dose fasting period).
Maltese: Ibandronic acid ittieħed 60 minuta qabel l-ewwel ikla jew xarba tal-ġurnata (perijodu ta' sawm ta' wara d-doża).
English: In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
Maltese: F'voluntiera rġiel b'saħħithom u nisa li għaddew mill-menopawża, ranitidina ġol-vina ġab żieda fil-bijodisponibiltà ta' ibandronic acid ta' madwar 20 % (li hi fil-varjabilità normali tal-bijodisponibiltà ta' ibandronic acid), probabilment bħala riżultat ta' aċidità gastrika mnaqqsa.
English: • tummy pain, indigestion
Maltese: • uġigħ ta' żaqq, indiġestjoni
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' ksur mifrux fuq 3 snin MF 4411 (%, 95 % CI) għal pazjenti b'punteġġ T tal-BMD tal-ispina lumbari inqas minn -2.5 fil-linja bażi ta' riferiment
English: - If you can't stand or sit upright for at least one hour (60 minutes) at a time.
Maltese: - Jekk ma tistax toqgħod bilwieqfa jew toqgħod bilqegħda dritta għal tal-anqas siegħa (60 minuta) fi kwalunkwe ħin.
English: • After taking your tablet, wait at least 30 minutes.
Maltese: • Wara li tieħu l-pillola tiegħek, stenna mill-inqas 30 minuta.
English: - Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
Maltese: - Acetylsalicylic acid u mediċini antinflammatorji mhux sterojdi oħra (NSAIDs) (li jinkludu ibuprofen, diclofenac sodium u naproxen) jistgħu jirritaw l-istonku u l-imsaen.
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 (MF 4411) inizjali ta' tliet snin, li sar b'mod każwali, double-blind, u bil-plaċebo bħala kontrolli, fuq il-ksur, intwera tnaqqis statistikament sinifikanti u medikament rilevanti dwar linċidenza ta' ksur morfometriku radjografiku ġdid u ksur vertebrali kliniku (tabella 3).
English: In the overall patient population of the study MF 4411, 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 tal-pazjenti globali tal-istudju MF 4411, ma ġie osservat ebda tnaqqis għal ksur mhux vertebrali, madankollu ibandronic acid li jittieħed kuljum deher effettiv f'sottopopolazzjoni ta' riskju għoli (punteġġ T ta' BMD ta' għonq femorali < -3.0), meta ġie osservat tnaqqis fir-riskju ta' ksur mhux vertebrali ta' 69 %.
English: Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
Maltese: Trattament ta' osteoporosi f'nisa li jkunu għaddew il-menopawsa u li jinsabu f'riskju ogħla ta' ksur (ara sezzjoni 5.1).
English: • Periodic Safety Update Reports
Maltese: • Rapporti Perjodi Aġġornati dwar is-Sigurtà
English: Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC - Aluminium) in cartons of 1 or 3 tablets.
Maltese: Ibrandronic Acid Teva jiġi fil-folji (PVC/Aclar/PVC - Aluminju) f'kartuni ta' pillola waħda jew 3 pilloli.
English: (see 3.
Maltese: Xahar 3
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 li għandhom indeboliment moderat tal-kliewi (CLcr ≥30 u <50 mL/min) jew indeboliment sever tal-kliewi (CLcr <30 mL/min) aġġustament fid-doża hu rakkomandat (ara sezzjoni 4.2).
English: Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see sections 4.4 and 4.5).
Maltese: Il-pazjenti għandhom jirċievu kalċju supplimentali u/jew vitamina D jekk it-teħid mid-dieta mhux adegwat (ara sezzjoni 4.4 u 4.5).
English: Pruritus
Maltese: Pożoloġija
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-impediment massimu medjan 6 ijiem wara d-doża kien ta' 74% bi tnaqqis fl-impediment medjan ta' 56% li ġie osservat 28 jum wara r-4 doża.
English: Most cases did not lead to cessation of therapy.
Maltese: Ħafna millkażijiet ma waslux għal waqfien ta' terapija.
English: Osteonecrosis of jaw
Maltese: Osteonekrosi tax-xedaq
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare
Maltese: Il-kategoriji ta' frekwenza huma definiti b'użu tal-konvenzjoni li ġejja: komuni ħafna (> 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
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, jew uġigħ fl-għadam.
English: Hypocalcaemia
Maltese: Ipokalċimija
English: In a Phase 1 bioequivalence study conducted in 72 postmenopausal women receiving 150 mg orally every 28 days for a total of four doses, inhibition in serum CTX following the first dose was seen as early as 24 hours post-dose (median inhibition 28 %), with median maximal inhibition (69 %) seen 6 days later.
Maltese: Fi studju ta' bijoekwivalenza ta' Fażi 1 li sar fuq 72 mara wara l-menopawsa li rċevew 50 mg millħalq kull 28 jum għal total ta' 4 dożi, l-impediment fis-serum ta' CTX wara l-ewwel doża kien muri minn kmieni sa 24 siegħa wara d-doża (impediment medjan ta' 28%), b'impediment massimu medjan (69%) li ġie osservat 6 ijiem wara.
English: If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic Acid Teva.
Maltese: Jekk qed tirċievi trattament dentali jew ser tagħmel kirurġija dentali (eż. qlugħ ta' snien), għarraf littabib tiegħek dwar it-trattament dentali tiegħek u għid lid-dentist tiegħek li qed tiġi ttrattat b'Ibrandronic Acid Teva.
English: This regimen reduced the occurrence of new radiographic vertebral fractures by 62 % (p=0.0001) over the three year duration of the study.
Maltese: Dan irreġimen naqqas il-każijiet ta' ksur vertebrali radjografiku ġdid bi 62 % (p=0.0001) fuq it-tliet snin tul tal-istudju.
English: - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions.
Maltese: - Iġene orali fqira, mard fil-ħanek, dentaturi li ma jeħlux sew, storja ta' mard dentali, proċeduri dentali invażivi eż. qlugħ ta' snien.
English: Patients should pay particular attention and be able to comply with the dosing instructions (see section 4.2).
Maltese: Il-pazjenti għandhom joqgħodu attenti partikolarment u jkunu kapaċi jikkonformaw mal-istruzzjonijiet dwar id-doża (ara sezzjoni 4.2).
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' inpjantazzjoni, interferenza fil-ħlas naturali, (distoċja), żieda fil-varjazzjonijiet vixxerali (sindromu tal-uretru pelviku renali) u abnormalitajiet tassnien fil-ġenerazzjoni F1 tal-firien.
English: Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see sections 4.4 and 5.2).
Maltese: Ibandronic Acid Teva mhux rakkomandat għal pazjenti li għandhom tneħħija tal-kreatinina inqas minn 30 mL/min minħabba l-esperjenza klinika limitata (ara sezzjonijiet 4.4 u 5.2).
English: Since acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Maltese: Peress li Acetylsalicylic acid, prodotti mediċinali Anti-Infjammatorji Mhux Sterojdi (NSAIDs) u bisphosphonates huma assoċjati ma' irritazzjoni gastrointestinali, għandu jkun hemm attenzjoni waqt għoti fl-istess waqt (ara sezzjoni 4.4).
English: Teva Nederland B.V. Tel: +31 800 0228 400
Maltese: Tel: +31 800 0228 400
English: Tabulated list of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi f'Tabella
English: • itching or tingling skin (paraesthesia)
Maltese: • ħakk jew tingiż fil-ġilda (parasteżija)
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 lisoenzimi P450 maġġuri umani tal-fwied u ntwera li ma jinduċix is-sistema taċ-ċitokromju P450 talfwied fil-firien (ara sezzjoni 5.2).
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Ibandronic Acid Teva tablets.
Maltese: Prodotti u supplimenti mediċinali (inkluż il-kalċju) għandhom jiġu evitati qabel ma jittieħdu l-pilloli Ibandronic Acid Teva.
English: Ibandronic acid 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Maltese: Densita minerali tal-għadam (Bone mineral density (BMD)) Ibandronic acid 150 mg li jingħata darba fix-xahar intwera li hu effettiv daqs ibandronic acid 2.5 mg li jingħata kuljum b'żieda fil-BMD fi studju (BM 16549) ta' sentejn li kien double-blind, multicentrali, b'osteoporosi li sar fuq nisa wara l-menopawsa (spina lumbarib'punteġġ ta' BMD T inqas minn2.5
English: At one year, 83.5 % (p= 0.006) of patients receiving ibandronic acid 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: Wara sena, 83.5 % (p= 0.006) ta' pazjenti li ħadu ibandronic acid 150 mg darba fix-xahar u 73. 9% ta' pazjenti li jirċievu ibandronic acid 2.5 mg kuljum kienu identifikati bħala li rrispondew (mfissra bi tnaqqis ta' ≥ 50 % mil-linja bażi ta' riferiment).
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 ta' riproduzzjoni fuq firien mogħtija l-mediċina minn ġolvina, ibandronic acid naqqas l-ammont ta' sperma meta mogħtija dożi ta' 0.3 u 1 mg/kg/kuljum u naqqas il-fertilità f-irġiel meta mogħtija 1 mg/kg/kuljum u fin-nisa meta mogħtija 1.2 mg/kg/kuljum.
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Maltese: Wara sentejn, 93.5% (p=0.004) u 86.4 % tal-pazjenti li ħadu ibandronic acid 150 mg darba fix-xahar jew ibandronic acid 2.5 mg kuljum, rispettivament irrispondew.
English: • asthma attacks
Maltese: • attakki tal-ażżma
English: Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea
Maltese: Esofaġite, Gastrite, Marda ta' rifluss gastro-esofagali, Dispepsja, Dijarea, Uġigħ addominali, Tqalligħ
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 indipendenti ta' riskju, pereżempju, BMD baxx, età, l-eżistenza ta' ksur preċedenti, storja filfamilja ta' ksur, rendiment għoli tal-għadam u indiċi baxx tal-massa korporali għandhom jiġu kkonsidrati sabiex jidentifikaw nisa li jisgħu jkunu f'riskju ta' ksur osteoporotiku.
English: Hypersensitivity reaction
Maltese: Reazzjoni ta' sensittività eċċessiva
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 avversi ta' ibandronic acid fi studji ta' tossiċità riproduttiva fil-far kienu dawk mistennija għal din il-klassi ta' prodotti mediċinali (bisfosfonati).