FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with moderate hypercalcaemia (albumincorrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose.
Maltese: F'pazjenti b'iperkalċimija moderata (kalċju fis-serum ikkoreġut bl-albumina < 3 mmol/l jew < 12 mg/dl) 2 mg hija doża effettiva.
English: Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the Ibandronate group compared to placebo.
Maltese: Konċentrazzjonijiet urinarji tal-markatur tal-assorbiment mill-ġdid tal-għadam CTx (C-terminal telopeptide rilaxxata minn collagen Tip I) kienu mnaqqsa b'mod sinifikattiv fil-grupp ta' ibandronic acid meta mqabbla mal-plaċebo.
English: Prior to treatment with Iasibon the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride.
Maltese: Qabel it-trattament b'Iasibon il-pazjent għandu jiġi rrijidratat biżżejjed b'9 mg/ml (0.9%) sodium chloride.
English: Hypocalcaemia
Maltese: - Ipokalċimija
English: Gastrointesti nal disorders
Maltese: Gastroenterite, gastrite,
English: As renal function decreases with age, this is the only factor to take into consideration (see renal impairment section).
Maltese: Hekk kif il-funzjoni renali tonqos bl-età, dan huwa l-uniku fattur li għandu jiġi kkunsidrat (ara s-sezzjoni dwar indeboliment tal-kliewi).
English: INFORMATION IN BRAILLE Iasibon 6 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Iasibon 6 mg
English: **See further information below †Identified in postmarketing experience.
Maltese: **Ara taħt għall-aktar informazzjoni †Identifikati minn esperjenza ta' wara t-tqegħid fis-suq.
English: • skin problems
Maltese: • problemi fis-snien
English: Sodium chloride Acetic acid, glacial Sodium acetate trihydrate Water for injections
Maltese: Sodium chloride Acetic acid, glacial Sodium acetate trihydrate Ilma għall-injezzjonijiet
English: The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50%) and the remainder is eliminated unchanged by the kidney.
Maltese: Il-frazzjoni ta' ibandronic acid assorbit jitneħħa miċ-ċirkolazzjoni permezz ta' assorbiment millgħadam (stmat bħala 40-50 %) u l-kumplament jiġi eliminat mhux mibdul permezz tal-kliewi.
English: Sodium acetate trihydrate sodium chloride, glacial acetic acid and water for injections.
Maltese: Sodium acetate trihydrate sodium chloride, glacial acetic acid, u ilma għall-injezzjonijiet.
English: Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4).
Maltese: Dijanjosi tal-kanċer, kemjoterapija, radjuterapija, kortikosterojdi u iġene orali batuta ukoll huma meqjusa bħala fatturi ta' riskju (ara sezzjoni 4.4).
English: All Skeletal Related Events (SREs) Placebo n=277
Maltese: Plaċebo n=277
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 l-isoenzimi P450 maġġuri umani tal-fwied u ntwera li ma jinduċix is-sistema taċ-ċitokromju P450 tal fwied fil-firien (ara sezzjoni 5.2).
English: • Prevention of Skeletal Events - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Maltese: Skeletriċi - miżjud ma' 100 ml ta' soluzzjoni isotonika ta' sodium chloride jew 100 ml ta' soluzzjoni ta' 5% dextrose u infuż fuq mill-inqas 15-il minuta.
English: Albumin-corrected Serum calcium (mmol/l)
Maltese: Kalċju fis-serum ikkoreġut bl-albumina (mmol/l)
English: Ocular inflammation 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: Azotaemia (uraemia)
Maltese: TWISSIJA(IET) SPEĊJALI
English: • rise in body temperature.
Maltese: • żieda fit-temperatura tal-ġisem
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg Ibandronate (154 patients).
Maltese: Pazjenti femminili b'kanċer tas-sider u metastasi fl-għadam ikkonfermat radjologikament kienu randomized biex jirċievu plaċebo (158 pazjent) jew 6 mg ibandronic acid (154 pazjent).
English: Frequency of administration
Maltese: Frekwenza ta' l-amministrazzjoni
English: Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate)
Maltese: Kull pillola miksija b'rita fiha 50 mg ta' ibandronic acid (bħala sodium monohydrate).
English: Breast -feeding
Maltese: Popolazzjoni pedjatrikai
English: Albumin-corrected Serum calcium (mg/dl)
Maltese: Kalċju fis-serum ikkoreġut bl-albumina (mg/dl)
English: Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder
Maltese: Dijarea, rimettar, dispepsja, uġigħ gastrointestinali, disturb f'sinna
English: INFORMATION IN BRAILLE Iasibon 2 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Iasibon 2 mg
English: Pelvic pain
Maltese: Uġigħ fil-pelvi
English: Iasibon 1 mg is supplied as pack containing 1 ampoule (2 ml type I glass ampoule).
Maltese: Iasibon 1 mg huwa disponibbli f'pakkett li fih ampulla waħda (ampulla tal-ħġieġ tip I ta' 2 ml).
English: Attention should also be paid to the possible existence of simultaneous hypomagnesaemia.
Maltese: Għandha tingħata attenzjoni wkoll għal possibbiltà ta' eżistenza ta' ipomanjesimja simultanja.
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 stimolata b'mod sperimentali u kkawżat millwaqfien tal-funzjoni tal-gonadi, retinojdi, tumuri jew estratti tat-tumuri.
English: • heart and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure) and varicose veins)
Maltese: • problemi tal-qalb u taċ-ċirkulazzjoni (inkluż palpitazzjonijiet, attakk tal-qalb, pressjoni għolja u vini varikużi)
English: Iasibon is indicated in adults for:
Maltese: Tirċievix Iasibon:
English: Tests for genotoxicity revealed no evidence of effects on genetic activity for ibandronic acid.
Maltese: Testijiet għal ġenotossiċità ma wrew l-ebda evidenza ta' effetti fuq l-attività ġenetika għal ibandronic acid.
English: Clinical studies in the treatment of tumour-induced hypercalcaemia Clinical studies in hypercalcaemia of malignancy demonstrated that the inhibitory effect of ibandronic acid on tumour-induced osteolysis, and specifically on tumour-induced hypercalcaemia, is characterised by a decrease in serum calcium and urinary calcium excretion.
Maltese: Studji kliniċi dwar iperkalċemija malinna wrew li l-effett inibitorju ta' ibandronic acid fuq osteolisi kkawżata mit-tumur, u speċifikament fuq iperkalċemija kkawżata minn tumur, hija kkaratterizzata minn tnaqqis fil-kalċju fis-serum u eliminazzjoni tal-kalċju fl-awrina.
English: Iasibon contains the active substance ibandronic acid.
Maltese: - Is-sustanza attiva hi ibandronic acid.
English: 5 vials
Maltese: 1 Kunjett 5
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' implantazzjoni, interferenza fil-ħlas naturali (distoċja), żjieda fil-varjazzjonijiet fil vixxri (sindrome tal-uretru pelviku renali) u anomaliji fis-snien fil-frieħ F1 fil-firien.
English: White round biconvex tablets
Maltese: Bluefish Pharmaceuticals AB
English: Mean Cmax was not increased in patients with mild renal impairment and increased by 12% in patients with moderate renal impairment.
Maltese: Cmax medja ma żdieditx f'pazjenti b'indeboliment renali ħafif, u żdiedet bi 12 % f'pazjenti b'indeboliment renali moderat.
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, and ocular inflammation (see paragraph “Description of selected adverse reactions” and section 4.4).
Maltese: L-aktar reazzjonijiet avversi serji rrappurtati huma reazzjoni anafilattika/xokk, ksur mhux tipiku talwirk, osteonekrosi tax-xedaq, irritazzjoni gastro-intestinali, u infjammazzjoni fl-għajnejn (ara l paragrafu “Deskrizzjoni ta' reazzjonijiet avversi magħżula” u sezzjoni 4.4).
English: 10vials
Maltese: Kunjetti 10 Kunjetti
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'madwar 90 % meta ibandronic acid jingħata ma' kolazzjon normali meta mqabbla malbijodisponibilità f'pazjenti sajmin.
English: Pooled data from these studies demonstrated a significant advantage for Ibandronate 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041).
Maltese: Dejta miġbura minn dawn l-istudji wriet vantaġġ sinifikanti għal ibandronic acid 50 mg p.o. fuq il-plaċebo biex inaqqas SREs imkejla b'SMPR (p=0.041).
English: - Patients should not lie down for 60 minutes after taking Iasibon.
Maltese: - Il-pazjenti m'għandhomx jimteddu qabel 60 minuta wara li jieħdu Iasibon.
English: Iasibon 6 mg concentrate for solution for infusion ibandronic acid
Maltese: Iasibon 6 mg konċentrat għal soluzzjoni għall-infużjoni ibandronic acid
English: Iasibon 2 mg concentrate for solution for infusion ibandronic acid
Maltese: Iasibon 2 mg konċentrat għal soluzzjoni għall-infużjoni ibandronic acid
English: Iasibon 6mg is supplied as packs containing 1, 5 and 10 vials (9 ml type I glass vial with a bromobutyl rubber stopper).
Maltese: Iasibon 6 mg huwa disponibbli bħala pakketti li fihom 1, 5 u 10 kunjetti (kunjett tal-ħġieġ tip I ta'
English: PHARMACEUTICAL FORM Film-coated tablets.
Maltese: calcium gluconate fil-vini.
English: No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Maltese: M'hemmx bżonn ta' aġġustament fid-dożaġġ għall-pazjenti b'indeboliment ħafif tal-kliewi (CLcr ≥50 u <80 ml/min).
English: Musculoskele tal and connective tissue disorders
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi
English: Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Iasibon in patients less than 18 years old.
Maltese: Popolazzjoni pedjatrika (ara sezzjoni 4.2 u sezzjoni 5.1) M'hemm l-ebda tagħrif dwar l-użu ta' Iasibon f'pazjenti b'età inqas minn 18-il sena.
English: Iasibon 2 mg is supplied as pack containing 1 ampoule (4 ml type I glass ampoule).
Maltese: Iasibon 2 ml huwa disponibbli f'pakkett li fih ampulla waħda (ampulla tal-ħġieġ tip I ta' 4 ml).
English: Iasibon contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: Iasibon fih inqas minn 1 mmol sodium (23 mg) f'kull kunjett, i.e. ‘essenzjalment bla sodju'
English: • aching joints, arthritis, or other joint problems
Maltese: • uġigħ fil-ġogi, artrite, jew problemi oħra fil-ġogi
English: In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Maltese: Barra dan, ibandronic acid ma jinibixxix lisoenzimi P450 maġġuri umani tal-fwied u ma jinduċix is-sistema taċ-ċitokromju P450 tal-fwied fil firien.
English: Table 1 lists adverse drug reactions from the pivotal phase III studies (Treatment of tumour induced hypercalcaemia: 311 patients treated with ibandronic acid 2 mg or 4 mg; Prevention of skeletal events in patients with breast cancer and bone metastases: 152 patients treated with ibandronic acid 6 mg), and from post-marketing experience.
Maltese: Tabella 1 telenka r-reazzjonijiet avversi tal-mediċina mill-istudji pivitali ta' fażi III (Kura ta' iperkalċimija kkawżata minn tumur: 311-il pazjent ikkurati b'ibandronic acid 2 mg jew 4 mg;
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Hypocalcaemia
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thusinteraction with other medicinal products, due to displacement is unlikely.
Maltese: L-għaqda mal-proteini fil-plażma umana hija bejn wieħed u ieħor 87% f'konċentrazzjonijiet terapewtiċi, u għalhekk interazzjoni ma' prodotti mediċinali oħra u oħra minħabba spostament mhux probabbli.
English: Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration.
Maltese: ibandronic acid mal-proteini hija madwar 87 % f'konċentrazzjonijiet terapewtiċi, ipoprotenemija f'mard sever tal-fwied x'aktarx ma twassalx għal żidiet ta' sinifikanza klinika fil-konċentrazzjoni ħielsa fil-plażma.
English: Bioavailability was reduced by approximately 75% when Iasibon tablets were administered 2 hours after a standard meal.
Maltese: Il-bijodisponibilità kienet imnaqqsa b'bejn wieħed u ieħor 75% meta pilloli Iasibon ingħataw sagħtejn wara ikla normali.
English: NAME OF THE MEDICINAL PRODUCT Iasibon 50 mg film-coated tablets ibandronic acid
Maltese: Kull pillola miksija b'rita fiha 50 mg ta' ibandronic acid,
English: Atypical subtrocha nteric and diaphysea l femoral fractures†
Maltese: Ksur subtrochanteric u diaphyseal mhux tipiku tal għadma tal-wirk
English: There is no evidence for clinically relevant interethnic differences between Asians and Caucasians in ibandronic acid disposition.
Maltese: M'hemmx evidenza ta' differenzi ta' rilevanza klinika bejn razza u oħra bejn l-Ażjatiċi u l-Kawkasi fid-disposizzjoni ta' ibandronic acid.
English: Othermedicines and Iasibon
Maltese: IL-PRODOTT MEDIĊINALI
English: Manufacturer Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki
Maltese: Il-Manifatturi Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki
English: Iasibon contains less than 1 mmol sodium (23 mg) per ampoule, i.e. essentially sodium free.
Maltese: Iasibon fih anqas minn 1 mmol sodium (23 mg) f'kull ampulla, ie essenzjalment 'sodium ħielsa.
English: In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or
Maltese: F'pazjenti b'iperkalċimija moderata (kalċju fis-serum ikkoreġut bl-albumina < 3 mmol/l jew <
English: The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Maltese: Il-firxa osservata ta' half-lifes apparenti hija wiesgħa u tiddependi fuq id-doża u s-sensittività tal-analażi, iżda l-half-life terminali apparenti ġeneralment hija fil-firxa ta' 10-60 siegħa.
English: Pegnancy
Maltese: Kunjett
English: Film-coated tablet
Maltese: Disturbi filqalb
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg Ibandronate (287 patients).
Maltese: Pazjenti femminili b'kanċer tas-sider u metastasi fl-għadam ikkonfermat radjoloġikament kienu randomized biex jirċievu plaċebo (277 pazjent) jew ibandronic acid 50 mg
English: • deafness
Maltese: • infezzjonijiet
English: • fluid in your lungs
Maltese: • fluwidu fil-pulmuni tiegħek
English: Urinary retention, renal cyst
Maltese: disfaġija, ħalq xott
English: The overall adverse event profile of ibandronic acid following the 15 minute infusion was consistent with the known safety profile over longer infusion times and no new safety concerns were identified relating to the use of a 15 minute infusion time.
Maltese: Il-profil totali ta' reazzjonijiet avversi ta' ibandronic acid wara l-infużjoni ta' 15-il minuta kien konsistenti mal-profil magħruf ta' sigurtà għall-infużjonijiet fuq medda ta' ħin itwal, u ma kien identifikat l-ebda tħassib ġdid dwar is-sigurtà relatat mal-użu ta' ħin tal-infużjoni ta' 15-il minuta.
English: Bone pain *
Maltese: FEJN MA
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 rrakkomandat 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-doża (ara sezzjoni 4.2).
English: Iasibon 1 mg concentrate for solution for infusion ibandronic acid
Maltese: Iasibon 1 mg konċentrat għal soluzzjoni għall-infużjoni ibandronic acid
English: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Maltese: Il-bijodisponibiltà u l-farmakokinetika ta' ibandronic acid huma simili fl-irġiel u fin-nisa.
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints.
Maltese: • sintomi jixbħu lill-influwenza, inkluż deni, tregħid u tertir, sensazzjoni ta' skomdu, għeja, uġigħ fl-għadam u uġigħ fil-muskoli u l-ġogi.
English: Sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections.
Maltese: Sodium chloride, glacial acetic acid, sodium acetate trihydrate u ilma għall-injezzjonijiet.
English: Store in the original package in order to protect from moisture.
Maltese: Aħżen fil-pakkett oriġinali sabiex tipproteġi mill-umdità.
English: One ampoule with 2 ml of a concentrate for solution for infusion contains2 mg ibandronic acid (as sodium monohydrate)
Maltese: Ampulla waħda b'2 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 2 mg ibandronic acid (bħala sodiummonohydrate).
English: See package leaflet for further information.
Maltese: Ara il-fuljett ta' tagħrif għal aktar informazzjoni.
English: Uncommon (may affect less than 1 in 100 people):
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000):
English: • shaking or shivering
Maltese: • rogħda jew tertir
English: Anaemia, blood dyscrasia
Maltese: Anemija, diskrasja taddemm
English: After reconstitution: 24 hours.
Maltese: Wara r-rikostituzzjoni: 24 siegħa.
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Iasibon tablets.
Maltese: Prodotti u supplimenti mediċinali (inkluż il-kalċju) għandhom jiġu evitati qabel ma jittieħdu l-pilloli Iasibon.
English: Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Iasibon therapy for metastatic bone disease.
Maltese: Ipokalċemija u disturbi oħra fil-metaboliżmu tal-għadam u l-minerali għandhom jiġu kkurati b'mod effettiv qabel ma tinbeda terapija b'Iasibon.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section 5.2):
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥30 u <50 ml/min) jew indeboliment sever tal-kliewi (CLcr <30 ml/min) li qed jiġu kkurati għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u marda metastatika tal-għadam għandhom jiġu segwiti r-rakkomandazzjonijiet ta' dożaġġ li ġejjin (ara sezzjoni 5.2):
English: Treatment of tumour-induced hypercalcaemia
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: • itching or tingling skin (paraesthesia)
Maltese: • ħakk jew tnemnim fil-ġilda (parasteżija)
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 dwar l-effett fuq is sistema riproduttiva fuq il-firien b'għoti fil-vina, ibandronic acid naqqas l-għadd tal-isperma b'dożi ta' 0.3 u 1 mg/kg/kuljum u naqqas il-fertilità fl-irġiel b'1 mg/kg/kuljum u fin-nisa b'1.2 mg/kg/kuljum.
English: Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Maltese: It-tneħħija totali ta' ibandronic acid kienet imnaqqsa għal 44 ml/min f'individwi b'indeboliment sever tal-kliewi meta mqabbel ma' 129 ml/min f'individwi b'funzjoni normali tal-kliewi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Maltese: U KWANTITATTIVA Kunjett wieħed b'6 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 6 mg ta' ibandronic acid (bħala sodium monohydrate).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/659/003
Maltese: FIS-SUQ EU/1/10/659/003
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Maltese: Osteonekrosi tax-xedaq, ġeneralment assoċjata mal-qligħ tas-snien u/jew infezzjoni lokali (inkluż osteomijelite) kienet irrappurtata f'pazjenti bil-kanċer li kienu qed jingħataw korsijiet ta' kura inkluż bisfosfonati primarji mogħtija fil-vini.
English: The number of SREs was also significantly reduced with Ibandronate 6 mg and there was a 40% reduction in the risk of a SRE over placebo (relative risk 0.6, p = 0.003).
Maltese: fuq il-plaċebo (riskju relattiv 0.6, p =0.
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: kellhom konċentrazzjonijiet ogħla fil-plażma, id-doppju jew it-triplu ta' individwi b'funzjoni normali tal-kliewi (CLcr ≥80 ml/min).
English: Pruritus
Maltese: Ipotermja
English: Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
Maltese: Osteonekrosi tax-xedaq huwa ġeneralment assoċċjat malqligħ tas-snien u/jew infezzjoni lokali (inkluż osteomijelite).
English: <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 b'indeboliment moderat tal-kliewi (CLcr ≥30 u <50 ml/min) jew indeboliment sever tal-kliewi (CLcr <30 ml/min) huwa rrakkomandat aġġustament fid-doża (ara Sezzjoni 4.2).
English: The median time to relapse (re-increase of serum albumin-corrected serum calcium above 3 mmol/l) was 1819 days for the 2 mg and 4 mg doses.
Maltese: kalċju fis-serum ikkoreġut bl-albumina) kien ta' 18 - 19-il ġurnata b'dożi ta' 2 mg u 4 mg.
English: Slovenija Pharmathen S.A.
Maltese: España Pharmathen S.A.
English: Pharmathen S.A. Dervenakion 6
Maltese: Kif taħżen Iasibon 6.
English: One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Maltese: Kunjett wieħed b'6 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 6 mg ibandronic acid (bħala sodium monohydrate).
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Maltese: Eżaminazzjoni tas-snien b'dentistrija preventiva xierqa għandha tiġi kkunsidrata qabel il-kura b'bisfosfonati f'pazjenti li għandhom fatturi ta' riskju oħra (eż. kanċer, kimoterapija, radjuterapija, kortikosterojdi, iġene orali batuta).