FrancophonIA/ELRC3.0 huggingface dataset:
English: This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken deferiprone in clinical studies.
Maltese: Din il-kundizzjoni, magħrufa bħala newtropenija jew agranuloċitosi seħħet 1 sa 2 persuni minn 100 li ħadu deferiprone fl-istudji kliniċi.
English: In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis and those episodes resolved once therapy was withdrawn.
Maltese: Fi provi kliniċi, l-immonitorjar ta' kull ġimgħa tal-għadd ta' newtrofili kien effettiv fl-identifikazzjoni ta' każijiet ta' newtropenija u agranuloċitosi u dawk l-episodji ġew riżolti ġaladarba t-terapija twaqqfet.
English: Coating
Maltese: Dijarea
English: Renal and urinary disorders Chromaturia General disorders and administration site conditions
Maltese: Doża eċċessiva kronika u disturbi newroloġiċi
English: What Deferiprone Lipomed looks like and contents of the pack Deferiprone Lipomed 500 mg film-coated tablets are white to off-white, glossy surface, oval filmcoated tablets.
Maltese: Kif jidher Deferiprone Lipomed u l-kontenut tal-pakkett Il-pilloli miksija b'rita ta' Deferiprone Lipomed 500 mg huma pilloli miksija b'rita, ovali, b'superfiċje tleqq ta' lewn abjad jew abjad jagħti fil-griż.
English: Deferiprone has been shown to cause neutropenia, including agranulocytosis.
Maltese: Intwera li deferiprone jikkawża n-newtropenija, li tinkludi agranuloċitosi.
English: Arthralgia
Maltese: Treddigħ
English: The higher rate of “Cardiac disorders” reported during combination therapy than monotherapy was possibly due to the higher incidence of pre-existing cardiac disorders in patients who received combination therapy.
Maltese: Ir-rata ogħla ta' “Disturbi tal-Qalb” irrapportata waqt it-terapija ta' kombinazzjoni kienet possibilment dovuta għall-inċidenza ogħla ta' disturbi kardijaċi eżistenti minn qabel f'pazjenti li rċevew terapija kombinata.
English: Peak serum concentrations of the glucuronide occur 2 to 3 hours after administration of deferiprone.
Maltese: Konċentrazzjonijiet massimi tal-glukoronide fis-serum iseħħu minn 2 sa 3 sigħat wara t-teħid ta' deferiprone.
English: Combination therapy with deferoxamine is not recommended when monotherapy with either chelator is adequate or when serum ferritin falls below 500 µg/l.
Maltese: It-terapija ta' kombinazzjoni mhix irrakkomandata meta l-monoterapija ma' kwalunkwe kelatur tkun inadegwata jew meta l-ferritin fisserum jaqa' għal inqas minn 500 µg/l.
English: Neurological disorders have been observed in children treated with more than 2.5 times the maximum recommended dose for several years but have also been observed with standard doses of deferiprone.
Maltese: Disturbi newroloġiċi kienu osservati fi tfal ikkurati b'aktar minn 2.5 darbiet tad-doża massima rakkomandata għal diversi snin kif ukoll b'dożi standard ta' deferiprone.
English: Atrophy of the thymus, lymphoid tissues, and testis, and hypertrophy of the adrenals, were reported at doses of 100 mg/kg/day or greater in non-iron-loaded animals.
Maltese: L-atrofija tat-timu, tat-tessut tal-limfa, u tat-testikoli, u ipertrofija tal-adrenali, kienu rrappurtati f'dożi ta' 100 mg/kg/jum jew iżjed f'annimali li ma kellhomx ħadid.
English: One pack contains 100 film-coated tablets.
Maltese: Pakkett wieħed fih 100 pillola miksija b'rita.
English: Deferiprone was teratogenic and embryotoxic in reproductive studies in non-iron-loaded pregnant rats and rabbits at doses at least as low as 25 mg/kg/day.
Maltese: Deferiprone kien teratoġeniku u embrijotossiku fi studji dwar ir-riproduzzjoni ta' firien u fniek tqal li ma kellhomx ħadid, f'dożi li kienu ta' mill-anqas 25 mg/kg/kuljum.
English: Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight.
Maltese: Deferiprone ġeneralment jingħata bħala 25 mg/kg piż korporali, mill-ħalq, tliet darbiet kuljum għal doża aħħarija ta' kuljum ta' 75 mg/kg piż korporali.
English: Regardless of the degree of renal impairment, the majority of the dose of deferiprone was excreted in the urine over the first 24 hours as deferiprone 3-O-glucuronide.
Maltese: Irrispettivament mill-grad ta' indeboliment renali, il-maġġoranza tad-doża ta' deferiprone kienet eliminata fl-awrina matul l-ewwel 24 siegħa bħala deferiprone 3-O-glucuronide.
English: Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Maltese: Deferiprone Lipomed jintuża biex jiġi ttrattat il-livell eċċessiv ta' ħadid ikkaġunat minn trasfużjonijiet frekwenti f'pazjenti b'talassemija meta t-terapija attwali ta' kelazzjoni hija kontraindikata jew inadegwata.
English: Neutropenia Agranulocytosis
Maltese: Tqala u treddigħ
English: There is a small chance that you may develop agranulocytosis (very low white blood cell count) while taking Deferiprone Lipomed, which may lead to a serious infection.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immunocompromised patients should not be initiated unless potential benefits outweigh potential risks.
Maltese: Minħabba li deferiprone jista' jkun assoċjat ma' newtropenija u agranuloċitosi, it-terapija f'pazjenti li huma kompromessi immunoloġikament m'għandhiex tinbeda ħlief jekk il-benefiċċji potenzjali ma jegħlbux ir-riskji potenzjali.
English: Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Deferiprone Lipomed”).
Maltese: (ara t-taqsima, “Mediċini oħra u Deferiprone Lipomed”);
English: (see 3.
Maltese: (ara 3.
English: Date of latest renewal: 18 December 2013
Maltese: Data tal-aħħar tiġdid: 18 ta' Diċembru 2013
English: INFORMATION IN BRAILLE Bonviva 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Bonviva 150 mg
English: Contains 154.6 mg anhydrous lactose (equivalent to 162.75 mg lactose monohydrate).
Maltese: Fih 154.6 mg ta' lactose anidru (ekwivalenti għal 162.75 mg lactose monohydrate).
English: Bonviva contains lactose.
Maltese: Bonviva fih lactose.
English: Bonviva is essentially sodium free.
Maltese: Bonviva huwa essenzjalment mingħajr sodium.
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 bilqiegħda dritt għal siegħa sħiħa (60 minuta).
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Maltese: Osteonekrosi talkanal estern tassmigħ (reazzjoni avversa tal-klassi ta' bisphosphonates)†
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: 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 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 issir stima mid-dejta disponibbli).
English: EU/1/03/265/003 EU/1/03/265/004
Maltese: EU/1/03/265/004
English: Osteonecrosis of jaw*†
Maltese: Osteonekrosi taxxedaq*†
English: Other medicines and Bonviva
Maltese: Mediċini oħra u Bonviva
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi huma mniżżla skont il-klassi tas-sistemi u tal-organi MedDRA u l-kategorija ta' frekwenza.
English: Lumbar spine L2-L4 BMD 3.8 [3.4, 4.2] 4.8 [4.5, 5.2] 4.8 [4.3, 5.4] 6.3 [5.7, 6.8]
Maltese: BMD 3.8 [3.4, 4.2]
English: Bonviva contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially “sodium-free”.
Maltese: Bonviva fih anqas minn 1 mmol ta' sodium (23 mg) f'kull doża (3 ml), i.e. essenzjalment “bla sodium”.
English: Bonviva intravenous injection decreased levels of serum C-telopeptide of the alpha chain of Type I collagen (CTX) within 3 - 7 days of starting treatment and decreased levels of osteocalcin within 3 months.
Maltese: Injezzjoni ġol-vina ta' Bonviva naqqset il-livelli ta' C-telopeptide tal-katina alpha tal-collagen tat-Tip 1 (CTX) fis-serum fi żmien 3 - 7 ijiem mill-bidu tal-kura u naqqset il-livelli ta' osteocalcin fi żmien 3 xhur.
English: 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: Rita tal-pillola: hypromellose, titanium dioxide (E 171), talc, macrogol 6000
English: Bonviva belongs to a group of medicines called bisphosphonates.
Maltese: Bonviva jagħmel parti minn grupp ta' mediċini msejħa bisphosphonates.
English: Arthralgia, Myalgia, Musculoskeletal pain, Muscle cramp, Musculoskeletal stiffness
Maltese: Artralġja, Mijalġja, Uġigħ muskoluskeletrali, Bugħawwieġ, Ebusija muskoluskeletrali
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta' Frar 2004
English: • Swallow your tablet with a full glass of water (at least 180 ml).
Maltese: • Ibla' l-pillola tiegħek ma' tazza mimlija bl-ilma (mill-inqas 180 ml)
English: Manufacturer Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR United Kingdom
Maltese: Il-manifattur Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14
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 Tnaqqis relattiv tar-riskju ta' ksur vertebrali kliniku
English: • For the next hour (60 minutes) after you've taken your tablet
Maltese: • Għas-siegħa sussegwenti (60 minuta) wara li tkun ħadt il-pillola tiegħek:
English: Bonviva 3 mg injection every 3 months (N=365)
Maltese: Injezzjoni ta' Bonviva 3 mg kull 3 xhur (N=365)
English: Bonviva 150 mg once monthly (N=320)
Maltese: Bonviva 150 mg darba fix-xahar (N=320)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/003 1 film-coated tablet EU/1/03/265/004 3 film-coated tablets
Maltese: FIS-SUQ EU/1/03/265/003 pillola waħda miksija b'rita EU/1/03/265/004 3 pilloli miksija b'rita
English: • Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Bonviva.
Maltese: • Supplimenti li fihom calcium, magnesium, iron jew aluminium, għax dawn jistgħu jinfluwenzaw l-effetti ta' Bonviva.
English: In vivo, ibandronic acid prevents experimentally induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.
Maltese: In vivo, ibandronic acid jippreveni d-distruzzjoni tal-għadam indotta bl-esperimenti permezz ta' waqfien tal-funzjoni gonadali, retinojdi, tumuri jew estratti tat-tumur.
English: Bonviva 3 mg solution for injection ibandronic acid
Maltese: Bonviva 3 mg soluzzjoni għall-injezzjoni Ibandronic acid
English: NAME OF THE MARKETING AUTHORISATION HOLDER Atnahs Pharma Netherlands B.V.
Maltese: Atnahs Pharma Netherlands B.V.
English: • do not take any other medicines
Maltese: • tiħux mediċini oħra
English: Bonviva, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Maltese: Bonviva, bħal bisphosphonates oħra mogħtija fil-vina, jista' jikkawża tnaqqis temporanju fil-valuri talkalċju fis-serum.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/265/005 1 pre-filled syringe EU/1/03/265/006 4 pre-filled syringes
Maltese: FIS-SUQ EU/1/03/265/005 siringa waħda mimlija għal-lest EU/1/03/265/006 4 siringi mimlija għal-lest
English: In the overall patient population of the study MF4411, no reduction was observed for non-vertebral fractures, however daily ibandronic acid appeared to be effective in a high-risk subpopulation (femoral neck BMD T-score < -3.0), where a non-vertebral fracture risk reduction of 69% was observed.
Maltese: Fil-popolazzjoni globali tal-pazjenti tal-istudju MF4411, ma kien osservat l-ebda tnaqqis għall-ksur mhux vertebrali, madankollu ibandronic acid kuljum deher li huwa effettiv f'sottopopolazzjoni ta' riskju għoli (punteġġ T tal-BMD tal-għonq femorali < -3.0), fejn kien osservat tnaqqis ta' 69% firriskju ta' ksur mhux vertebrali.
English: Femoral neck BMD 1.7 [1.3, 2.1]
Maltese: BMD tal-għonq tal-wirk 1.6 [1.2, 2.0]
English: Bonviva tablets are white to off white, of oblong shape and marked “BNVA” on one side, and “150” on the other side.
Maltese: Il-pilloli Bonviva tablets huma bojod sa offwajt, ta' forma oblung u għandhom marka “BNVA” fuq naħa, u marka “150” fuq in-naħa l-oħra.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose 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 ilprodott mediċinali.
English: The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10-72 hours.
Maltese: L-skala tal-half-lives apparenti osservati hija wiesgħa, l-half-life terminali apparenti ġeneralment hija fl-iskala ta' 10-72 siegħa.
English: Bonviva 150 mg once monthly
Maltese: Bonviva 150 mg darba fixxahar
English: • If you have any swallowing or digestive problems.
Maltese: • Jekk għandek problemi biex tibla' jew problemi diġestivi.
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 tal-esofagu bħal djuq jew akalasja - Inabbiltà li toqgħod bilwiefqa jew bilqiegħda dritt għal mill-inqas 60 minuta
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 I imwettaq fuq 72 mara wara l-menopawsa, 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: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Bonviva administration.
Maltese: Waqt ittrattament, proċeduri dentali invażivi għandhom isiru biss wara konsiderazzjoni b'attenzjoni u għandhom jiġu evitati qrib ta' għoti ta' Bonviva.
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' irritazzjoni gastro-intestinali, għandha tingħata attenzjoni waqt għoti flimkien.
English: In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bonviva 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
Maltese: Fi studju ta' sentejn f'nisa wara l-menopawsa b'osteoprożi (BM 16549) is-sigurtà globali ta' Bonviva 150 mg darba fix-xahar u ibandronic acid 2.5 mg kuljum kienet simili.
English: • If your kidneys are not functioning normally.
Maltese: • Jekk il-kliewi tiegħek mhux qed jaħdmu b'mod normali.
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 (NSAIDsNonsteroidal Anti-Inflammatory medicinal products) u bisphosphonates huma assoċjati ma' irritazzjoni gastrointestinali, għandu jkun hemm attenzjoni waqt l-għoti flimkien (ara sezzjoni 4.4).
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving Bonviva 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 Bonviva 150 mg darba fix-xahar jew ibandronic acid 2.5 mg kuljum, rispettivament, kienu dawk li rrispondew.
English: After one year (primary analysis) the median relative change from baseline was -76 % for Bonviva 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 Bonviva 150 mg darba fix-xahar u -67 % għal ibandronic acid 2.5 mg kuljum.
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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq ilportal web Ewropew tal-mediċini.
English: Bonviva 150 mg film-coated tablets are supplied in blisters (PVC/PVDC, sealed with aluminium foil) containing 1 or 3 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fiħ Bonviva 150 mg pilloli miksija b'rita huma disponibbli f'folji (PVC/PVDC, issiġillat b'fojl talaluminju) li fihom 1 jew 3 pilloli.
English: Bonviva 3 mg intravenous injection, administered every 3 months, was shown to be at least as effective as oral ibandronic acid 2.5 mg daily in a 2-year, randomised, double-blind, multicentre, noninferiority study (BM16550) of postmenopausal women (1386 women aged 55 - 80) with osteoporosis (lumbar spine BMD T-score below -2.5 SD at baseline).
Maltese: Fi studju ta' ħafna ċentri, double-blind, randomizzat, mhux ta' inferjorità ta' sentejn (BM 16550) ta' nisa wara l-menopawsa (1386 mara ta' età ta' 55 - 80) b'osteoporożi (punteġġ T tal-BMD tas-sinsla lumbari taħt -2.5
English: 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 bi 3 ml ta' soluzzjoni fiha 3 mg ibandronic acid (bħala sodium monohydrate).
English: Bonviva 150 mg film-coated tablets Ibandronic acid
Maltese: Bonviva150 mg pilloli miksija b'rita Ibandronic acid
English: Children and adolescents Do not give Bonviva to children or adolescents below 18 years.
Maltese: Tfal u adolexxenti Tagħtix Bonviva lil tfal jew adolexxenti ta' età inqas minn 18-il sena.
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: Oesophagitis, Gastritis, Gastro oesophageal reflux disease, Dyspepsia, Diarrhoea, Abdominal pain, Nausea
Maltese: Esofaġite, Gastrite, Marda ta' rifluss gastroesofagali, Dispepsja, Dijarea, Uġigħ addominali, Tqalligħ
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 bijokimiċi tal-bidla tal-għadam (bħal CTX urinarju u Osteocalcin tas-serum) urew id-disinn mistenni tas-soppressjoni għal-livelli ta' qabel il-menopawsa u laħqu s-soppressjoni massima f'perijodu ta' 3-6 xhur.
English: The overall proportion of patients who experienced an adverse reaction was 26.0 % and 28.6 % for Bonviva 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' Bonviva 3 mg kull 3 xhur wara sena u sentejn, rispettivament.
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 ogħla minn individwi b'funzjoni tal-kliewi normali u t-tneħħija totali ta' ibandronic acid kienet ta' 44 ml/min.
English: Lumbar spine L2-L4 BMD 3.9 [3.4, 4.3]
Maltese: BMD 3.9 [3.4, 4.3] BMD totali tal-ġenbejn 2.0
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 użaw imblokkaturi ta' histamine (H2) jew inibituri tal-pompi tal-protoni wara sena u sentejn, rispettivament.
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-ġenbejn totali, tal-għonq tal-wirk u tat-trokanter wara sena (analiżi primarja), u sentejn ta' kura (Popolazzjoni Per-Protokoll) flistudju BM 16549.
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)
English: Bonviva may help lower the chances of breaking bones (fractures).
Maltese: Bonviva jista' jgħin inaqqas ir-riskju ta' ksur ta' għadam (fratturi).
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: Xahar nru 1 __/__/__ 3 pilloli miksija b'rita Xahar nru 2 __/__/__ 3 pilloli miksija b'rita Xahar nru 3 __/__/__ 3 pilloli miksija b'rita Niżżel id-data ta' meta tieħu l-pillola tiegħek Iftaħ
English: In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of Bonviva 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Maltese: Fl-istudju pivitali ta' sentejn f'nisa wara l-menopawsa b'osteoprożi (BM16550), is-sigurtà globali ta' injezzjoni ġol-vina ta' Bonviva 3 mg kull 3 xhur u ibandronic acid 2.5 mg orali kuljum intweriet li kienet simili.