FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe rash occurred in less than 1 % of patients treated with efavirenz, and 1.7 % discontinued therapy because of rash.
Maltese: Inqas minn 1 % tal-pazjenti kkurati b'efavirenz kellhom raxx qawwi, u 1.7 % ma komplewx il-kura minħabba r-raxx.
English: If efavirenz is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Maltese: darunavir/ritonavir 600/100 mg darbtejn kuljum.
English: Bristol-Myers Squibb Pharmaceuticals Ltd. Tel: +44 (0800) 731 1736
Maltese: Tel: +44 (0800) 731 1736
English: The increased efavirenz concentrations observed following administration of STOCRIN with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).
Maltese: Il-konċentrazzjonijiet ogħla ta' efavirenz li ġew osservati wara l-għoti ta' STOCRIN mal-ikel jistgħu jwasslu għal żieda fil-frekwenza tar reazzjonijiet avversi (ara sezzjonijiet 4.4 u 5.2).
English: Co-administration with elbasvir/grazoprevir due to the expected significant decreases in elbasvir and grazoprevir plasma concentrations (see section 4.5).
Maltese: L-għoti flimkien ma' elbasvir/grazoprevir minħabba t-tnaqqis sinifikanti mistenni filkonċentrazzjonijiet fil-plażma ta' elbasvir u grazoprevir (ara sezzjoni 4.5).
English: Warfarinor acenocoumarol(medicines used to reduce clotting of the blood): your doctor may need to adjust your dose of warfarin or acenocoumarol.
Maltese: Warfarin jew acenocoumarol (mediċini użati biex inaqqsu t-tagħqid tad-demm): it-tabib tiegħek jista' jkollu bżonn jaġġusta d-doża tiegħek ta' warfarin jew ta' acenocoumarol.
English: Patients taking drugs that are known to prolong the QTc interval (proarrhythmic).
Maltese: Prodott mediċinali skond l-oqsma terapewtiċi (doża)
English: Each film-coated tablet contains: efavirenz 50 mg
Maltese: Kull pillola miksija b'rita fiha: 50 mg ta' efavirenz
English: Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Maltese: L-għoti flimkien ma' terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew ergot alkaloids (ngħidu aħna, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) billi lkompetizzjoni għal CYP3A4 minn efavirenz tista' twassal biex timpedixxi l-metaboliżmu u toħloq il potenzjal għal reazzjonijiet avversi serji u/jew ta' theddida għall-ħajja.
English: These adverse reactions were identified through post-marketing surveillance but not reported as drug-related events for efavirenz-treated patients in 16 clinical trials.
Maltese: Dawn ir-reazzjonijiet avversi kienu identifikati permezz ta' sorveljanza ta' wara t-tqegħid fis-suq iżda ma ġewx irrapportati bħala każijiet marbuta mal-mediċina fil-pazjenti kkurati b'efavirenz f'16-il prova klinika.
English: Outer carton PC:
Maltese: Kodiċi ATC:
English: Among co-infected patients, 3 % of those treated with efavirenz and 2 % in the control arm discontinued because of liver disorders (see section 4.4).
Maltese: Fost il-pazjenti koinfettati, 3% minn dawk ikkurati b'efavirenz u 2% fil-fergħa ta' kontroll ma komplewx l-istudju minħabba disturbi fil fwied (ara sezzjoni 4.4).
English: HDPE bottles with a child-resistant polypropylene closure containing 180 ml of oral solution.
Maltese: Il-fliexken fihom 180 ml ta' soluzzjoni orali.
English: The dose of lopinavir/ritonavir tablets should be increased to 500/125 mg twice daily when co-administered with efavirenz 600 mg once daily.
Maltese: Id-doża ta' pilloli ta' lopinavir/ritonavir għandu jiżdied għal 500/125 mg darbtejn kuljum meta mogħti flimkien ma'
English: The pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1 % of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.2).
Maltese: Il-karatteristiċi farmakokinetiċi ta' efavirenz ma ġewx studjati f'pazjenti b'insuffiċjenza fil-kliewi; madankollu, inqas minn 1 % tad-doża ta' efavirenz titneħħa fl-awrina bla ma tinbidel, għalhekk limpatt tal-indeboliment tal-kliewi fuq it-tneħħija ta' efavirenz huwa minimu (ara sezzjoni 4.2).
English: INFORMATION IN BRAILLE Bondenza 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Bondenza 150 mg
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Maltese: Il-manifattur Roche Pharma AG Emil-Barell-Strasse 1
English: Bondenza contains lactose.
Maltese: Bondenza fih lactose.
English: Contains 162.75 mg lactose monohydrate (equivalent to 154.6 mg anhydrous lactose).
Maltese: Fih 162.75 mg lactose monohydrate (ekwivalenti għal 154.6 mg ta' lactose anidru).
English: Marketing Authorisation Holder Roche Registration Limited 6 Falcon Way
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq Roche Registration Limited 6 Falcon Way
English: Galactose intolerance
Maltese: Intolleranza għal galactose
English: Clinically meaningful reductions in serum CTX levels were observed at all time points measured, i.e. months 3, 6, 12 and 24.
Maltese: Tnaqqis ta' sinifikat kliniku fil-livelli fis-serum ta' CTX kienu osservati fil-punti kollha ta' ħin imkejjla, i.e. xhur 3, 6, 12 u 24.
English: In table 1 an overview of adverse reactions is presented.
Maltese: Fit-tabella 1 hija ppreżentata deskrizzjoni qasira ta' reazzjonijiet avversi.
English: Frequency categories are defined using the following convention: very common (>1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) ,very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti skont il-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: Femoral neck BMD 1.7 [1.3, 2.1]
Maltese: BMD tal-għonq tal-wirk 1.7 [1.3, 2.1]
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jissottometti PSURs għal dan il-prodott skont il-kondizzjonijiet stipulati fil-lista ta' dati ta' referenza tal-Unjoni (lista EURD) ipprovduta taħt Artiklu 107c(7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-Web-portal Ewropea għall-Mediċini.
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 oħra anti-infjammatorji mhux sterojdi (NSAIDs) (inkluż ibuprofen, diclofenac sodium u naproxen) jistgħu jirritaw l-istonku u l-imsaren.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23.02.2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23.02.2004
English: Paediatric population (see section 4.2 and section 5.2).
Maltese: Popolazzjoni pedjatrika (ara sezzjoni 4.2 u sezzjoni 5.2).
English: Lactose monohydrate Povidone
Maltese: Qalba tal-pillola Lactose monohydrate Povidone
English: Titanium dioxide (E 171)
Maltese: Kisja tal-pillola Hypromellose Titanium dioxide (E 171) Talc
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 bilqegħda dritt għal siegħa sħiħa (60 minuta).
English: Other medicines and Bondenza
Maltese: Mediċini oħra u Bondenza
English: Trochanter BMD
Maltese: BMD tat-trokanter
English: There is limited data available on patients of African origin.
Maltese: Hemm tagħrif limitat disponibbli dwar pazjenti ta' oriġini Afrikana.
English: Bone mineral density (BMD)
Maltese: Densità tal-minerali tal-għadam (BMD)
English: Bondenza 150 mg once monthly (N=291)
Maltese: Bondenza 150 mg darba fixxahar (N=291)
English: Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI) Placebo (N=974)
Maltese: Tabella 3: Riżultati mill-istudju ta' 3 snin dwar ksur, MF 4411(%, 95%, CI) Plaċebo (N=974)
English: Vascular disorders Gastrointestinal disorders
Maltese: Disturbi vaskulari Disturbi gastrointestinali
English: Also contains sodium chloride, glacial acetic acid, sodium acetate trihydrate, water for injections.
Maltese: Fih ukoll sodium chloride, glacial acetic acid, sodium acetate trihydrate, ilma għall-injezzjonijiet.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration Ltd.
Maltese: Roche Registration Ltd.
English: Bondenza is essentially sodium free.
Maltese: Bondenza huwa essenzjalment mingħajr sodium.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/266/005 1 pre-filled syringe EU/1/03/266/006 4 pre-filled syringes
Maltese: FIS-SUQ EU/1/03/266/005 siringa mimlija għal-lest EU/1/03/266/006 4 siringi mimlija għal-lest
English: Bondenza belongs to a group of medicines called bisphosphonates.
Maltese: Bondenza jagħmel parti minn grupp ta' mediċini msejħa bisphosphonates.
English: Bondenza 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-vini ta' Bondenza naqqset il-livelli ta' C-telopeptide tal-katina alpha tal-collagen tat-Tip 1 (CTX) fis-serum fi żmiet 3 - 7 ijiem mill-bidu tal-kura u naqqset il-livelli ta' osteocalcin fi żmien 3 xhur.
English: - The active substance is ibandronic acid.
Maltese: - Is-sustanza attiva hi ibandronic acid.
English: Bondenza contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially “sodiumfree”.
Maltese: Bondenza fih anqas minn 1 mmol ta' sodium (23 mg) f'kull doża (3 ml), i.e. essenzjalment “bla sodium”.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3 mg/3 ml
Maltese: INDIVIDWALI 3 mg/3 ml
English: Musculoskeletal and , connective tissue disorders
Maltese: Disturbi muskoluskeletrali u tat-tessut konnettiv
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH
Maltese: A MANIFATTUR(I) RESPONSABBLI
English: Bondenza 150 mg film-coated tablets are supplied in blisters (PVC/PVDC, sealed with aluminium foil) containing 1 or 3 tablets.
Maltese: Bondenza 150 mg pilloli miksija b'rita huma disponibbli f'folji (PVC/PVDC, issiġillat b'fojl talaluminju) li fihom 1 jew 3 pilloli.
English: Missed dose:
Maltese: Doża eċċessiva:
English: - Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Bondenza.
Maltese: - Supplimenti li fihom calcium, magnesium, iron jew aluminium, għax dawn jistgħu jinfluwenzaw l-effetti ta' Bondenza.
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 ta' l-annimali Ibandronic acid ipproduċa bidliet biokimiċi li jindikaw inibizzjoni talassorbiment mill-ġdid ta' l-għadam li tiddependi fuq id-doża, inkluż soppressjoni ta' markaturi biokimiċi tad-degradazzjoni tal-kollaġen ta' l-għadam (bħal deoxypyridinoline, u cross linked Ntelopeptides ta' kollaġen tat-tip I (NTX).
English: The incidence of clinical vertebral fractures was also significantly reduced by 49 % (p=0.011).
Maltese: L-inċidenza ta' ksur vertebrali kliniku kienet ukoll mnaqqsa b'mod sinifikanti b'49% (p=0.011).
English: - The other ingredients are: tablet core: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid purified, silica colloidal anhydrous tablet coat: hypromellose, titanium dioxide (E 171), talc, macrogol 6000
Maltese: Qalba tal-pillola: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid purified, silica colloidal anhydrous
English: In vivo, ibandronic acid prevents bone destruction experimentally induced by cessation of gonadal function, retinoids, tumours or tumour extracts.
Maltese: In vivo, ibandronic acid jipprevjeni id-distruzzjoni ta' l-għadam indotta bl-esperimenti permezz ta' waqfien tal-funzjoni gonadali, retinojdi, tumuri jew estratti tat-tumur.
English: Bondenza 150 mg once monthly (N=320)
Maltese: Bondenza 150 mg darba fix-xahar (N=320)
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Bondenza 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 l-possibbiltà ta' dawn l-effetti irritanti u l-potenzjal ta' rkadar talmarda prinċipali, għandu jkun hemm kawtela meta Bondenza jingħata lill-pazjenti bi problemi attivi tal-apparat gastro-intestinali ta' fuq (eż. esofagu ta' Barrett magħruf, disfaġija, mard esofagali ieħor, gastrite, duwodenite jew ulċeri).
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 ta' l-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: In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Maltese: F'analiżi multivarjata, l-età ma nstabitx li hija fattur indipendenti fl-ebda wieħed mill-parametri farmakokinetiċi studjati.
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: Bondenza 3 mg injection every 3 months (N=365)
Maltese: Injezzjoni ta' Bondenza 3 mg kull 3 xhur (N=365)
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 bisphosphonates it-tnejn, huma assoċjati ma' rritazzjoni gastro-intestinali, għandha tingħata attenzjoni waqt għoti flimkien.
English: Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Maltese: Osteonekrosi tax-xedaq huwa ġeneralment assoċjat mal-qlugħ ta' sinna u / jew infezzjoni lokali (inkluż osteomijelite).
English: Month 1 __/__/__ 3 film-coated tablets Month 2 __/__/__ 3 film-coated tablets Month 3 __/__/__ 3 film-coated tablets Note down the date you take your tablet
Maltese: 2 __/__/__ 3 pilloli miksija b'rita Xahar no. 3 __/__/__ 3 pilloli miksija b'rita Niżżel id-data ta' meta tieħu l-pillola tiegħek Iftaħ
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-biodisponibiltà tonqos b'madwar 90% meta ibandronic acid jingħata ma' kolazzjon stàndard meta mqabbla ma' biodisponibiltà osservata f'individwi sajmin.
English: Bondenza 3 mg solution for injection ibandronic acid
Maltese: Bondenza 3 mg soluzzjoni għall-injezzjoni Ibandronic acid
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 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 ta' użu ta' ibandronic acid 2.5 mg kuljum.
English: - Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 - Hypocalcaemia - Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes
Maltese: - Sensittività eċċessiva għal ibandronic acid jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1. - Ipokalċimija - Anormalitajiet tal-esofagu li jittardjaw t-tbattil ta' l-esofagu bħal djuq jew akalasja - Inabbiltà li toqgħod bilwiefqa jew bilqiegħda dritt għal mill-inqas 60 minuta
English: 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
Maltese: Siringa mimlija għal-lest waħda + labra għall-injezzjoni waħda 4 siringi mimlija għal-lest + 4 labar għall-injezzjoni.
English: One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
Maltese: Pillola waħda fiha 150 mg ta' ibandronic acid (bħala sodium monohydrate).
English: Bondenza tablets are white to off white, of oblong shape and marked “BNVA” on one side, and “150” on the other side.
Maltese: Il-pilloli Bondenza tablets huma bojod sa offwajt, ta' forma oblung u mmarkati b' “BNVA” fuq naħa, u b'“150” fuq in-naħa l-oħra.
English: Where Bondenza is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.
Maltese: Fejn il-prodott mediċinali jingħata ġo linja ta' l-infużjoni ġol-vini eżistenti, is-soluzzjoni għallinfużjoni għandha tiġi limitata għal isotonic saline jew soluzzjoni tal-glukosju ta' 50 mg/ml (5 %).
English: What Bondenza contains - The active substance is ibandronic acid.
Maltese: X'fih Bondenza - Is-sustanza attiva hi ibandronic acid.
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-vini ta' dożi xierqa ta' calcium gluconate, potassium jew sodium phosphate, u magnesium sulfate.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta' glucose-galactose m' għandhomx jieħdu dan il-prodott mediċinali.
English: In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bondenza 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Maltese: Fi studju ta' sentejn f'nisa wara l-menopawża b'osteoprożi (BM 16549), is-sigurtà globali ta' Bondenza 150 mg darba fix-xahar u ibandronic acid 2.5 mg kuljum kienet simili.
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: Mat-tieni sena 78.7 % (p=0.002) u 65.6 % tal-pazjenti kienu identifikati bħala dawk li rrispondew fil-gruppi ta' 150 mg kull xahar u 2.5 mg kuljum rispettivament.
English: It's important to keep taking Bondenza every month.
Maltese: Huwa importanti li tibqa' tieħu Bondenza kull xahar.
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 manjesju fis-serum għandu jiġi kkoreġut b'għotja minn ġol-vini ta' calcium gluconate, potassju jew sodium phosphate, u magnesium sulfate, rispettivament.
English: It contains the active substance ibandronic acid.
Maltese: Fih is-sustanza attiva ibandronic acid.
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-ġembejn, 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: Bondenza 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, randomized, mhux ta' inferjorità ta' sentejn (BM 16550) ta' nisa wara l-menopawża (1386 mara b'età ta' 55 - 80) b'osteoporożi (punteġġ T tal-BMD tas-sinsla lumbari taħt -2.5
English: Bondenza 3 mg injection every 3 months (N=334)
Maltese: Injezzjoni ta' Bondenza 3 mg kull 3 xhur (N=334)
English: Gastrointestinal adverse reactions
Maltese: Reazzjonijiet gastro-intestinali avversi
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
Maltese: Fi studju ta' bioekwivalenza ta' Fażi I imwettaq f'72 mara wara l-menopawża li kienu qed jirċievu 150 mg orali kull 28 ġurnata għal total ta' erba' dożi, kienet osservata inibizzjoni fis-CTX tas-serum wara l-ewwel doża sa minn 24 siegħa wara d-doża (inibizzjoni medjana ta' 28 %), b'inibizzjoni medjana massima (69 %) osservata 6 ijiem wara.
English: General advice:
Maltese: Parir ġenerali:
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-vini 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: 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 biokimiċi ta' assorbiment mill-ġdid ta' l-għadam kien osservat minn xahar wara l-bidu tal-kura b'ibandronic acid 2.5 mg.
English: Plasma concentrations of ibandronic acid increase in a dose-proportional manner after intravenous administration of 0.5 mg to 6 mg.
Maltese: Konċentrazzjonijiet fil-plażma ta' ibandronic acid jiżdiedu b'mod proporzjonali mad-doża wara għotja ġol-vini ta' 0.5 mg sa 6 mg.
English: Incidence of new morphometric vertebral fractures Relative risk reduction of clinical vertebral fracture Incidence of clinical vertebral fracture
Maltese: Tnaqqis relattiv tar-riskju Ksur vertebrali morfometriku ġdid Inċidenza ta' ksur vertebrali morfometriku ġdid
English: - The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.
Maltese: - Is-sustanzi l-oħra huma sodium chloride, acetic acid, sodium acetate trihydrate u ilma għallinjezzjonijiet.
English: ibandronic acid 2.5 mg daily
Maltese: Ibandronic acid 2.5 mg kuljum