FrancophonIA/ELRC3.0 huggingface dataset:
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: Wara sentejn il-bidla relattiva medjana kienet ta' -68 % u62 %, fid-driegħ tad-doża ta' 150 mg ta' kull xahar u 2.5 mg kuljum rispettivament.
English: BMD - mean change relative to baseline total hip at year 3
Maltese: BMD - bidla relattiva meta mqabbla mal-linja bażi totali tal-ġenbejn fit-3 sena
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic Acid Teva is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Maltese: Minħabba dawn l-effetti irritanti possibbli u minħabba li dawn jistgħu jaggravaw il-marda flisfond, kawtela għandha tiġi użata meta Ibrandronic Acid Teva tingħata lil pazjenti li jkollhom problemi gastrointestinali attivi fuq in-naħa ta' fuq (eż. magħrufa bħala esofagu ta' Barrett, disfaġja, mard esofaġeali ieħor, gastrite, duwodenite jew ulċeri).
English: Due to limited clinical experience, Ibandronic Acid Teva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2).
Maltese: Minħabba esperjenza klinika limitata, Ibandronic Acid Teva mhuwiex rakkomandat għal pazjenti bi tneħħija tal-krejatinina taħt 30 mL/min (ara sezzjoni 5.2).
English: Fatigue
Maltese: Tqala
English: Biochemical markers of bone turn-over
Maltese: Markers bijokimiċi ta' turnover ta' għadam
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06
Maltese: Prodotti mediċinali għall-kura ta' disturbi fl-għadam, bisfosfonati, Kodiċi ATC:
English: Subjects with severe renal impairment (CLcr ≤ 30 mL/min) receiving oral administration of 10 mg ibandronic acid daily for 21 days, had 2-3 fold higher plasma concentrations than subjects with normal renal function (CLcr ≥80 mL/min).
Maltese: Individwi b'indeboliment sever fil-kliewi (CLcr ≤ 30 mL/min) li kienu qed jirċievu doża orali ta' 10 mg ibandronic acid kuljum għal 21 jum, kellhom żieda ta' 2-3 darbiet tal-konċentrazzjoni fil-plażma ta' pazjenti bil-kliewi normali (CLcr ≥80 mL/min).
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Maltese: Bisfosfonati li jingħataw mill-ħalq jistgħu jikkawżaw irritazzjonijiet lokali fil-mukosa gastrointestinali ta' fuq.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis (see section 4.8).
Maltese: Osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw) kienet irrappurtata b'mod rari ħafna flambjent ta' wara t-tqegħid fis-suq f'pazjenti li jirċievu Ibrandronic Acid Teva għall-osteoporożi (ara sezzjoni 4.8).
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: Markers Bijokemikali ta' turnover tal-għadam (bħal CTX urinarju u Osteocalcin fis-serum) urew l-iskema mistennija ta' trażżin fil-livelli ta' qabel il-menopawsa u laħqu t-trażżin l-massimu fi żmien perijodu ta' 3-6 xhur.
English: A clinically meaningful reduction of 50 % of biochemical markers of bone resorption was observed as early as one month after start of treatment with ibandronic acid 2.5 mg.
Maltese: Tnaqqis klinikament notevoli ta' 50 % tal-markers bijokimiċi għal assorbiment mill-ġdid tal-għadam kien osservat sa minn xahar qabel il-bidu tal-kura b'ibandronic acid 2.5 mg.
English: Ibandronic acid 2.5 mg daily (N=318)
Maltese: Ibandronic acid 2.5 mg kuljum (N=318)
English: Ibandronic Acid Teva is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Maltese: Ibrandronic Acid Teva huwa indikat fl-adulti fil-prevenzjonijiet ta' każijiet skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl-għadam li jeħtieġu r-radjuterapija jew il-kirurġija) f'pazjenti b'kanċer tas-sider u metastasi fl-għadam.
English: - If you have any swallowing or digestive problems.
Maltese: - Jekk għandek problemi biex tibla' jew problemi diġestivi.
English: Rare (may affect up to 1 in 1000 people):
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1000):
English: Bioavailability was reduced by approximately 75% when ibandronic acid tablets were administered 2 hours after a standard meal.
Maltese: Il-bijodisponibilità kienet imnaqqsa b'madwar 75 % meta l-pilloli ta' ibandronic acid ingħataw sagħtejn wara ikla standard.
English: Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates.
Maltese: Dan jagħmel parti minn grupp ta' mediċini msejħa bisfosfonati.
English: Duodenitis
Maltese: Treddigħ
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 ta' inqas minn 30 mL/min) li kienu qed jirċievu doża orali ta' 10 mg ibandronic acid kuljum għal 21 jum, kellhom żieda ta' 2-3 darbiet tal-konċentrazzjoni fil-plażma ta' pazjenti bil-kliewi normali u t-tneħħija totali ta' ibandronic acid kien ta' 44 mL/min.
English: Tablet coating:
Maltese: Popolazzjoni pedjatrika:
English: Ibandronic acid 2.5 mg daily (N=977)
Maltese: Ibandronic acid 2.5 mg kuljum (N=977)
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-vini.
English: Table 1 lists adverse reactions from 2 pivotal phase III studies (Prevention of skeletal events in patients with breast cancer and bone metastases: 286 patients treated with ibandronic acid 50 mg administered orally), and from post-marketing experience.
Maltese: III (Prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam: 286 pazjent ikkurati b'ibandronic acid 50 mg mogħti mill-ħalq), u minn esperjenza ta' wara t-tqegħid fis-suq.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Ibandronic Acid Teva 50 mg: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Ibrandronic Acid Teva 50 mg: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Ibandronic acid 2.5 mg daily (N=294)
Maltese: Ibandronic acid 2.5 mg kuljum (N=294)
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 iżgħar ta' siti ta' inpjantazzjoni, interferenza fil-ħlas naturali, (distoċja), żieda fil-varjazzjonijiet vixxerali (sindromu tal-uretru pelviku renali).
English: Since Nonsteroidal Anti-Inflammatory medicinal products and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Maltese: Peress li prodotti mediċinali Anti-Infjammatorji mhux Sterojdi u bisfosfonati huma t-tnejn assoċjati ma' irritazzjoni gastrointestinali, wieħed għandu joqgħod attent meta l-mediċini jingħataw flimkien.
English: Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo.
Maltese: Ilkonċentrazzjonijiet urinarji tal-marker ta' assorbiment mill-ġdid tal-għadam CTx (C-terminal telopeptide rilaxxata minn kollaġen ta' Tip I) kienu mnaqqsa b'mod sinifikattiv fil-grupp ta' ibandronic acid meta mqabbla mal-plaċebo.
English: One year data in study BM 16549 Two year data in study BM
Maltese: Tagħrif wara sena fi studju BM 16549
English: - Patients should not lie down for 60 minutes after taking Ibandronic Acid Teva.
Maltese: - Il-pazjenti m'għandhomx jimteddu qabel 60 minuta wara li jieħdu Ibandronic Acid Teva.
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg ibandronic acid (287 patients).
Maltese: Pazjenti nisa b'kanċer tas-sider u metastasi fl-għadam ikkonfermat radjoloġikament ġew magħżula b'mod każwali biex jirċievu plaċebo (277 pazjent) jew 50 mg ibandronic acid (287 pazjent).
English: *See further information below †Identified in post-marketing experience.
Maltese: *Ara taħt għall-aktar informazzjoni †Identifikati minn esperjenza ta' wara t-tqegħid fis-suq.
English: In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of ibandronic acid 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Maltese: Fi studju ta' sentejn f'nisa ta' wara l-menopawsa b'osteoporożi (BM 16549) is-sigurtà globali ta' ibandronic acid 150 mg li jittieħed darba fix-xahar u ibandronic acid 2.5 mg li jittieħed kuljum kienu l istess.
English: Ibandronic acid 2.5 mg daily (N=575)
Maltese: Ibandronic acid 2.5 mg kuljum (N=575)
English: Fasting should be continued for at least 30 minutes after taking the tablet.
Maltese: Is-sawma għandha tkompli għal mill-inqas 30 minuta wara li tieħu l-pillola.
English: Clinical studies have not shown any evidence of deterioration in renal function with long term ibandronic acid therapy.
Maltese: Studji kliniċi ma wrewx evidenza ta' deterjorazzjoni fil-funzjoni renali b'terapija fit-tul ta' ibandronic acid.
English: Medicinal product-Food Interaction
Maltese: Interazzjonijiet ma' Prodotti mediċinali oħra
English: Therefore, it is recommended that the tablets should be taken after an overnight fast (minimum 6 hours) and fasting should continue for at least 30 minutes after the dose has been taken (see section 4.2).
Maltese: Għalhekk, huwa rakkomandat li l-pilloli jittieħdu wara sawma ta' bil-lejl (minimu ta' 6 sigħat) u s-sawma trid titkompla għal mill-inqas 30 minuta wara li tkun ittieħdet id-doza (ara sezzjoni 4.2).
English: There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Maltese: Mhemmx evidenza għal differenzi interetniċi ta' rilevanza klinika bejn l-Azjatiċi u l-Kawkasi fiddispożizzjoni ta' ibandronic acid.
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: Wara sentejn, 87.1% (p<0.001) u 70.5%,ta' pazjenti ssodisfaw dan il-kriterju fid-driegħ ta' 150 mg kull xahar u 2.5 mg kuljum rispettivament.
English: In table 1 a complete list of known adverse reactions is presented.
Maltese: Fit-tabella 1 hija ppreżentata lista kompluta ta' reazzjonijiet avversi magħrufa.
English: Ibandronic acid 150 mg once monthly
Maltese: Ibandronic acid 150 mg darba fixxahar
English: Musculoskele tal stiffness
Maltese: Taħrix talażżma
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, ocular inflammation, (see paragraph “Description of selected adverse reactions” and section 4.4).
Maltese: L-aktar reazzjonijiet avversi serji rrappurtati huma reazzjoni/xokk anafilattika, ksur mhux tipiku talgħadma tal-wirk, osteonekrosi tax-xedaq, irritazzjoni gastro-intestinali, u infjammazzjoni fl-għajnejn (ara l-paragrafu “Deskrizzjoni ta' reazzjonijiet avversi magħżula” u sezzjoni 4.4).
English: The anti-fracture effect was consistent over the duration of the study.
Maltese: L-effett ta' kontra lksur kien konsistenti matul l-istudju.
English: After one year (primary analysis) the median relative change from baseline was -76 % for ibandronic acid 150 mg once monthly and -67 % for ibandronic acid 2.5 mg daily.
Maltese: Wara sena (analiżi primarja) il-bidla relattiva medjana mil-linja ta' riferiment bażi kienet ta' -76 % għal ibandronic acid 150 mg li jingħata darba fix-xahar u -67 % għal ibandronic acid 2.5 mg li jingħata kuljum.
English: • dizziness
Maltese: Duwodenite
English: - Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Ibandronic Acid Teva.
Maltese: - Supplimenti li fihom il-kalċju, il-manjesju, il-ħadid jew l-aluminju, peress li jpossibilment jistgħu jinfluwenza l-effetti ta' Ibrandronic Acid Teva.
English: This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
Maltese: Dan għaliex jista' jikkawża irritazzjoni, infjammazzjoni jew ulċeri fil-pajp tal-ikel/gerżuma (esofagu).
English: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Ibandronic Acid Teva tablets.
Maltese: Prodotti li fihom il-kalċju u ketajins multivalenti oħra (bħal aluminju, manjesju u l-ħadid) li jinkludu lħalib, u l-ikel, x'aktarx jinterferixxu fl-assorbiment tal-pilloli Ibrandronic Acid Teva.
English: The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Maltese: Il-mira primarja ta' effikaċja tal-provi kienet ir-rata tal-perijodu tal-morbidità skeletrika (SMPR).
English: Ibandronic acid 150 mg once monthly (N=320)
Maltese: Ibandronic acid 150 mg darba fix-xahar (N=320)
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: Sun.
Maltese: Teva
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Ibandronic Acid Teva administration.
Maltese: Waqt it-trattament, proċeduri dentali invażivi għandhom isiru biss wara konsiderazzjoni b'attenzjoni u għandhom jiġu evitati qrib ta' għoti ta' Ibrandronic Acid Teva.
English: It contains the active substance ibandronic acid.
Maltese: Hu fih is-sustanza attiva ibandronic acid.
English: Tests for genotoxicity revealed no evidence of genetic activity for ibandronic acid.
Maltese: Testijiet għal ġenotossiċità ma wrew l-ebda evidenza ta' attività ġenetika għal ibandronic acid.
English: The other ingredients are:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Maltese: Mhemm bżonn ta' ebda aġġustament fid-doża għal pazjenti li għandhom indeboliment ħafif tal-kliewi (CLcr ≥50 u <80 mL/min).
English: • headache
Maltese: • sturdament
English: You may have a severe inflammation of your gullet/food pipe, possibly with sores or constriction of the gullet/food pipe
Maltese: Jista' jkollok infjammazzjoni severa ta' griżmejk/pajp tal-ikel, possibilment b'feriti jew djuq tal-gerżuma/pajp tal-ikel
English: Ocular inflammation*†
Maltese: Infjammazzjoni fl-għajnejn*†
English: Other medicines and Ibandronic Acid Teva
Maltese: Mediċini oħra u Ibandronic Acid Teva
English: There is no relevant use of Ibandronic Acid Teva in children below 18 years, and Ibandronic Acid Teva was not studied in this population (see section 5.1 and section 5.2).
Maltese: Mhemmx użu rilevanti ta' Ibrandronic Acid Teva fi tfal b'età inqas minn 18-il sena, u Ibrandronic Acid Teva ma ġiex studjat f'din il-popolazzjoni pedjatrika (ara sezzjoni 5.1 u sezzjoni 5.2).
English: Due to the limited clinical experience, ibandronic acid is not recommended in patients with severe renal impairment (see sections 4.2 and 4.4).
Maltese: Minħabba l-esperjenza klinika ristretta, ibandronic acid mhux rakkomandat għal pazjenti li għandhom indeboliment sever talkliewi (ara sezzjonijiet 4.2 u 4.4).
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 f'espożizzjonijiet ħafna aktar eċċessivi mill-espożizzjoni massima umana li tindika ftit rilevanza għall-użu kliniku.
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Maltese: M'hemmx tnaqqis sinifikanti fil-bijodisponibilità kemm-il darba ibandronic acid jittieħed 60 minuta qabel ikla.
English: For total hip BMD, 90.0 % (p<0.001) of patients receiving ibandronic acid 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-ġenbejn, 90.0 % (p<0.001) tal-pazjenti li ħadu ibandronic acid 150 mg darba fixxahar u 76.7 % ta' pazjenti li rċevew ibandronic acid 2.5 mg kuljum kellhom żieda fil-BMD totali talġenbejn li hu ugwali għal jew aktar mill-punt ta' riferiment fil-linja bażi.
English: At two years 93.4 % (p<0.001) of patients receiving ibandronic acid 150 mg once monthly and 78.4 %, of patients receiving ibandronic acid 2.5 mg daily had total hip BMD increases above or equal to baseline.
Maltese: Wara sentejn 93.4 % (p<0.001) ta' pazjenti li ħadu ibandronic acid 150 mg darba fix-xahar u 78.4%, ta' pazjenti li ħadu ibandronic acid 2.5 mg kuljum kellhom żieda fil-BMD totali tal-ġenbejn daily li kien ugwali għal jew aktar minn dak ta' riferiment fil-linja bażi.
English: In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen.
Maltese: F'dan l-istudju, ibandronic acid kien evalwat f'dożi orali ta' 2.5 mg darba kuljum u 20 mg b'mod intermittenti bħala reġimen esploratorju.
English: Pharmachemie B.V.
Maltese: Pillola miksija b'rita.
English: It's important to follow these instructions carefully.
Maltese: Huwa importanti li ssegwi l-istruzzjonijiet b'attenzjoni.
English: There are only very few data available on patients with African origin.
Maltese: Hemm tagħrif limitat ħafna dwar pazjenti ta' oriġini Afrikana.
English: There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Maltese: L-ebda evidenza ta' tossiċita diretta fuq il-fetu jew effetti teratoġeniċi ma ġew osservati għal ibandronic acid fil-firien u fil-fniek ittrattati b'mod orali u ma kienx hemm effetti avversi fuq liżvilupp ta' ġenerazzjoni F1 ta' firien f'espożizzjoni ekstrapolata ta' mill-inqas 35 darba aktar minn dik tal-bniedem.
English: Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Maltese: Tagħrif miġbur minn dawn l-istudji wrew vantaġġ sinifikanti għal ibandronic acid 50 mg p.o. fuq il-plaċebo fit-tnaqqis ta' SREs imkejjel mill-SMPR (p=0.041).
English: The safety and efficacy of Ibandronic Acid Teva in children and adolescents below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ibandronic Acid Teva fit-tfal u l-adoloxxenti b'età inqas minn 18-il sena ma ġewx stabbiliti.
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for oncology indications (see section 4.8).
Maltese: Osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw) kienet irrappurtata b'mod rari ħafna flambjent ta' wara t-tqegħid fis-suq f'pazjenti li jirċievu Ibrandronic Acid Teva għal indikazzjonijiet onkoloġiċi (ara sezzjoni 4.8).
English: Bone mineral density (BMD)
Maltese: GĦAMLA KWALITATTIVA
English: Tel: +386 1 58 90 390
Maltese: Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic Acid Teva therapy.
Maltese: Pazjenti b'disturbi fil-metaboliżmu tal-għadam u tal-minerali L-ipokalċemija u disturbi fil-metaboliżmu tal-għadam u l-minerali għandhom jiġu trattati effettivament qabel ma tinbeda t-terapija b'Ibrandronic Acid Teva.
English: Musculoskele tal and connective tissue disorders
Maltese: Disturbi muskoluskeltriċi u tat-tessut konnettiv
English: BMD - mean change relative to baseline lumbar spine at year 3 BMD - mean change relative to baseline total hip at year 3
Maltese: BMD - bidla relattiva meta mqabbla mal-linja bażi tal-ispina lumbari fit-3 sena
English: Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Ibandronic Acid Teva.
Maltese: Irritazzjoni, infjammazzjoni jew ulċerazzjoni tal-gerżuma/pajp tal-ikel (esofagu) ta' spiss b'sintomi li jistgħu jseħħu ta' uġigħ sever fis-sider, uġigħ sever wara li tibla' l-ikel u/jew ix-xorb, nawsea severa jew remettar, speċjalment jekk tixrob tazza mimlija ilma u/jew jekk tmur tistrieħ fi żmien siegħa minn meta tieħu Ibandronic Acid Teva.
English: Oesophagitis including oesophageal ulcerations or strictures and dysphagia, Vomiting, Flatulence
Maltese: Esofaġite inkluż ulċerazzjonijiet jew kontrazzjonijiet esofagali u disfaġija, Rimettar, Gass fl-istonku
English: Other things that can increase the risk of fractures include: - not enough calcium and vitamin D in the diet, - smoking, or drinking too much alcohol, - not enough walking or other weight-bearing exercise, - a family history of osteoporosis.
Maltese: Affarijiet oħra li jistgħu jżidu r-riskju ta' ksur jinkludu: - ma jkollokx biżżejjed kalċju u vitamina D fid-dieta, - tipjip, jew meta tixrob ħafna alkoħol, - ma timxix biżżejjed jew tagħmel eżerċizzji ta' piżijiet, - storja fil-familja ta' osteoporosi.
English: Patients with hepatic impairment (see section 4.2)
Maltese: Popolazzjoni pedjatrika (ara sezzjoni 4.2 u sezzjoni 5
English: Children and adolescents Ibandronic Acid Teva should not be used in children and adolescents below the age of 18 years.
Maltese: Tfal u adolexxenti Ibandronic Acid Teva m'għandux jintuża fi tfal u adolexxenti b'età inqas minn 18-il sena.
English: A relative risk reduction of 61 % was observed after 2 years (p=0.0006).
Maltese: Tnaqqis relattiv fir-riskju ta' 61 % kien osservat wara sentejn (p=0.0006). Ebda differnza statistikament sinifikanti ma ġiet miksuba wara sena ta' trattament (p=0.056)..
English: Bioavailability is reduced by about 90 % when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Maltese: Il-bijodisponibilità hija mnaqqsa b'90 % meta ibandronic acid jingħata ma' kolazzjon normali meta mqabbla mal-bijodisponibilità f'pazjenti sajmin.
English: In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
Maltese: In vivo, ibandronic acid jimpedixxi l-qerda tal-għadam stimolat b'mod sperimentali u kkawżat bilwaqfa tal-funzjoni tal-gonadi, retinojdi, tumuri jew estratti tat-tumuri.
English: Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Maltese: Tabella 3 Riżultati Sekondarji ta' Effikaċja (Pazjenti b'Kanċer tas-Sider b'Mard Metastatiku tal-Għadam)
English: Angioedema, Face oedema, Urticaria
Maltese: Esofaġite, uġigħ addominali, dispepsja, tqalligħ
English: Atypical subtrochanteric and diaphyseal femoral fractures†
Maltese: Ksur subtrochanteric u diaphyseal mhux tipiku tal-għadma tal-wirk †