FrancophonIA/ELRC3.0 huggingface dataset:
English: - Sodium chloride
Maltese: - Sodium chloride HIPRAMUNE T (solvent):
English: HIPRAMUNE T (solvent): Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Maltese: Tħallatx ma ebda prodott mediċinali veterinarju ieħor, ħlief mas-solvent ipprovdut għal użu ma' dan il-prodott mediċinali veterinarju.
English: EXP {month/year} Once diluted use within 10 hours.
Maltese: Jiskadi {xahar/sena} Ladarba jiġi dilwit, uża fi żmien 10 sigħat.
English: (Invented)
Maltese: (ivvintat)
English: 10 vials for solution for infusion
Maltese: 10 kunjetti għal konċentrat għal soluzzjoni għall-infużjoni
English: Strength
Maltese: Isem
English: Packaging
Maltese: Trab
English: Package size name
Maltese: Daqs tal-pakkett
English: • List of diagnoses or adverse events (AE) terms that trigger ADR reporting for MIRCERA .
Maltese: • Lista ta' terminoloġija ta' dijanjosi jew ta' avvenimenti avversi (AE) li jwasslu għal rapport ta' ADR għal MIRCERA.
English: • A questionnaire to gather detailed ADR report documentation.
Maltese: • Kwestjonarju biex tinġabar dokumentazzjoni dettaljata ta' rapport ta' ADR.
English: • The MAH's offer of testing or re-testing antibody (AB) status in a reference laboratory.
Maltese: • L-offerta tad-Detentur ta' L-Awtorizzazzjoni għat-Tqegħid fis-Suq li jeżamina jew jeżamina mill-ġdid l-istat ta' l-antikorpi (AB) fl-laboratorju ta' referenza.
English: • Need and clinical importance of adverse drug reaction (ADR) reporting in general.
Maltese: • Il-bżonn u l-importanza klinika ġenerali li jiġu rrappurtati reazzjonijiet avversi tal-mediċina (ADR).
English: The MAH shall provide physicians prior to launch with an educational material that will include the following components of information:
Maltese: Qabel it-tqegħid fis-suq, id-Detentur ta' L-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jipprovdi lit-tobba materjal ta' edukazzjoni li jkun jinkludi l-komponenti ta' informazzjoni li ġejjin:
English: • Background data on erythropoietin antibody-mediated pure red cell aplasia (AEAB-mediated
Maltese: • Tagħrif ġenerali dwar aplasija pura taċ-ċelloli l-ħomor ikkawżata minn antikorpi għalleritropoetin (PRCA ikkawżata minn AEAB) assoċjata ma' kura b'sustanzi li jistimulaw leritropoesi (ESA).
English: AEAB-mediated PRCA, the diagnostic work-up of potential AEAB-mediated PRCA, the need of discontinuation of ESA treatment due to cross-reactivity with other ESAs on diagnosis of
Maltese: • Letteratura biex tipprovdi informazzjoni dwar it-telf ta' effett u l-kawżi differenzjali ta' dan, definizzjoni ta' PRCA ikkawżata minn AEAB, attivitajiet li jwasslu għal dijanjosi ta' PRCA ikkawżata minn AEAB potenzjali, l-bżonn li titwaqqaf il-kura ta' ESA wara dijanjosi ta' PRCA ikkawżata minn AEAB minħabba reazzjoni nkroċjata ma' ESAs oħrajn.
English: MA (EU) number (Invented) name
Maltese: Numru MA (EU) Isem (ivvintat)
English: London, 01 April 2008 EMEA/CHMP/180097/2008
Maltese: Londra, 01 ta' April 2008 EMEA/180089/2008
English: The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Michał Pirożynski.
Maltese: IrRapporteur kien id-Dr Ian Hudson l-ko-Rapporteur kien id-Dr Michał Pirożynski.
English: Common Name: Haemophilus influenzae type b polysaccharide (polyribosyl ribitol phosphate) conjugated to tetanus toxoid and Neisseria meningitidis serogroup C (MenC) polysaccharide conjugated to tetanus toxoid
Maltese: Isem komuni: Polisakkaride tal-Haemophilus influenzae tat-tip b (polyribosyl ribitol phosphate) konjugat ma' tossojde tat-tetnu u polisakkaride tan-Neisseria meningitidis tasserogrupp C (MenC) konjugat ma' tossojde tat-tetnu
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
Maltese: OPINJONI DWAR RIFERIMENT SKOND L-ARTIKOLU 29(4)1 GĦAL
English: Menitorix, 5 micrograms PRP with 12,5 micrograms TT, 5 micrograms PSC with 5 micrograms TT in the form of Powder and Solvent for Solution for Injection is a vaccine, indicated for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) in infants from the age of 2 months and children up to the age of 2 years.
Maltese: Menitorix, 5 mikrogrammi PRP bi 12.5 mikrogrammi TT, 5 mikrogrammi PSC b'5 mikrogrammi TT filforma ta' trab u solvent għal soluzzjoni injettabbli huwa vaċċin, indikat għall-prevenzjoni ta' mard invażiv ikkawżat minn Haemophilus influenzae tat-tip b (Hib) u Neisseria meningitidis tal-grupp C (MenC) fit-trabi mill-età ta' xahrejn u tfal żgħar sa l-età ta' sentejn.
English: GlaxoSmithKline Biologicals submitted applications for mutual recognition of Menitorix, 5 micrograms PRP with 12,5 micrograms TT, 5 micrograms PSC with 5 micrograms TT in the form of powder and solvent for solution for injection, on the basis of the marketing authorisation granted by the United Kingdom on 19 December 2005.
Maltese: GlaxoSmithKline Biologicals ippreżentat applikazzjonijiet għar-rikonoxximent reċiproku ta' Menitorix, 5 mikrogrammi PRP bi 12.5 mikrogrammi TT, 5 mikrogrammi PSC b'5 mikrogrammi TT fil-forma ta' trab u solvent għal soluzzjoni injettabbli, fuq il-bażi ta' l-awtorizzazzjoni għat-tqegħid fis-suq mir-Renju Unit fid19 ta' Diċembru 2005.
English: The United Kingdom referred the reasons for disagreement to the EMEA on 29 March 2007.
Maltese: Ir-Renju Unit rrefera rraġunijiet għan-nuqqas ta' qbil lill-EMEA fid-29 ta' Marzu 2007.
English: The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Maltese: Il-proċedura ta' arbitraġġ bdiet fis-26 ta' April 2007 permezz ta' l-adozzjoni ta' lista ta' mistoqsijiet.
English: The Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Greece, Ireland, Poland and Spain.
Maltese: L-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri Konċernati kienu l-Belġju, il-Greċja, l-Irlanda, ilPolonja u Spanja.
English: A positive opinion was adopted by consensus on 15 November
Maltese: Ġiet adottata opinjoni pożittiva permezz ta' kunsens fil-15 ta' Novembru 2007.
English: During their November 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Menitorix, that the objections raised by Greece, Poland and Spain should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Waqt il-laqgħa tiegħu f'Novembru 2007, is-CHMP, fid-dawl tat-tagħrif globali ppreżentat u fid-dawl taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-fehma li l-bilanċ bejn il-benefiċċji u r-riskji kien favorevoli għal Menitorix, li l-objezzjonijiet imqajma mill-Greċja, il-Polonja u Spanja ma għandhomx jimpedixxu lgħoti ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju tal-Karatteristiċi tal-Prodott, it-tikketta u lfuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom jiġu emendati.
English: The Marketing Authorisation Holder provided written explanations on 19 July 2007 and on 17 October 2007.
Maltese: Id-Detentur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq ta spjegazzjonijiet bil-miktub fid-19 ta' Lulju 2007 u fis-17 ta' Ottubru
English: The final opinion was converted into a Decision by the European Commission on 01 April 2008.
Maltese: L-opinjoni finali hija konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fl-01 ta' April 2008.
English: EU/1/11/685/001 EU/1/11/685/002 EU/1/11/685/003 EU/1/11/685/004 EU/1/11/685/005
Maltese: EU/1/11/685/001 EU/1/11/685/002 EU/1/11/685/003 EU/1/11/685/004
English: Date of latest renewal: 13 April 2016
Maltese: Data tal-aħħar tiġdid: 13 ta' April 2016
English: Representative Office in Latvia K.Valdemāra Str. 33 - 30
Maltese: Sandoz d.d. Representative Office in Latvia K.Valdemāra Str. 33 - 30
English: Titanium dioxide
Maltese: Hypromellose Titanium dioxide
English: Azotaemia (uraemia)
Maltese: Ażotemija (uraemia)
English: LV-1010 Riga
Maltese: LV-1010
English: System Organ Class
Maltese: Klassi tal-Organi
English: Domaniewska 50 C 02-672 Warszawa Poland
Maltese: Domaniewska 50 C 02-672 Warszawa
English: - tablet coat: titanium dioxide, lactose monohydrate, hypromellose, macrogol 4000
Maltese: - kisja tal-pillola: titanium dioxide, lactose monohydrate, hypromellose, macrogol 4000.
English: 6, Dervenakion EL-15351 Pallini Attiki Greece
Maltese: 6, Dervenakion EL-15351 Pallini Attiki
English: Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Maltese: Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Il-Greċja
English: Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany
Maltese: Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Il-Ġermanja
English: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
Maltese: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Il-Greċja
English: No data are available (see section 5.1 and 5.2).
Maltese: Dejta mhux disponibbli (ara sezzjoni 5.1 u 5.2).
English: Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Germany
Maltese: Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Il-Ġermanja
English: Stevens-Johnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Maltese: Sindrome ta' Stevens-Johnson †, Eritema Multiforme†, Dermatite Bulluża†
English: Verovškova 57, 1526 Ljubljana Slovenia
Maltese: Lek Pharmaceuticals d.d. Verovškova 57, 1526 Ljubljana Is-Slovenja
English: Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki
Maltese: Il-Manifatturi Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki
English: Str. Livezeni nr. 7A, RO-540472 Targu-Mures Romania
Maltese: Livezeni nr. 7A, RO-540472 Targu-Mures
English: 8B, fl. 6 BG-1766 Sofia
Maltese: BG-1766 Sofia
English: Hypocalcaemia**
Maltese: Ipokalċemija**
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 tal-frekwenzi huma definiti permezz tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: This reduction in urinary CTx levels was significantly correlated with the primary efficacy endpoint SMPR (Kendall-tau-b (p<0.001)).
Maltese: Dan it-tnaqqis fil-livelli urinarji ta' CTx kien ikkorrelat b'mod sinifikattiv mal-mira primarja tal-effikaċja ta' SMPR (Kendall-tau-b (p 0.001)).
English: - organizačná zložka Galvaniho 15/C
Maltese: Slovenská republika Sandoz d.d. - organizačná zložka Galvaniho 15/C
English: Ibandronic acid 50 mg n=287
Maltese: Ibandronic acid Sandoz 50 mg n=287
English: All Skeletal Related Events (SREs) Placebo n=277
Maltese: L-Avvenimenti Kollha Relatati mal-Iskeletru (SREs) Plaċebo n=277
English: Ibandronic acid Sandoz 50 mg film-coated tablets are supplied in Polyamide/Al/PVC - Aluminium foil blister with 3, 6, 9, 28 or 84 tablets, packaged in a cardboard box.
Maltese: Pilloli miksija b'rita ta' Ibandronic acid Sandoz 50 mg huma disponibbli f'folji ta' Polyamide/Al/PVC - Aluminum li fihom 3, 6, 9, 28 u 84 pillola, ippakjati f'kaxxa tal-kartun.
English: Hypersensitivity†, bronchospasm†, angioedema†, Anaphylactic reaction/shock†**
Maltese: Sensittività eċċessiva†, Bronkospażmi†, anġjoedema†, Reazzjoni anafilattika/xokk anafilattiku †**
English: Κηφισίας 18 & Γκύζη GR - 151 25 Μαρούσι Τηλ: +30 216 600 500 0
Maltese: Sandoz Pharmaceuticals D.D. Κηφισίας 18 & Γκύζη GR - 151 25 Μαρούσι Τηλ: +30 216 600 500 0
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi MedRA u l-kategorija tal-frekwenza.
English: Mutagenicity/Carcinogenicity:
Maltese: Mutaġeniċità/Karċinoġeniċità
English: P-2740-255 Porto Salvo Tel: +351 21 924 1911
Maltese: Porto Salvo Tel: +351 21 924 1911
English: Osteonecrosis of jaw†**, osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) †
Maltese: Osteonekrosi taxxedaq†** Osteonekrożi talkanal estern tassmigħ (reazzjoni avversa għallklassi bifosfonati)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 July 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 ta' Lulju 2011
English: H-1114 Budapest Tel: +36 1 430 2890 info.hungary@sandoz.com
Maltese: Budapest Tel: +36 1 430 2890 info.hungary@sandoz.com
English: 3 film-coated tablets 6 film-coated tablets 9 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Maltese: 3 pilloli miksija b'rita 6 pilloli miksija b'rita 9 pilloli miksija b'rita 28 pillola miksija b'rita 84 pillola miksija b'rita
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions
Maltese: Il-fatturi ta' riskju li ġejjin għandhom jiġu kkunsidrati meta jiġi evalwat ir-riskju tal-pazjent li jiżviluppa ONJ: - Il-qawwa tal-prodott mediċinali li jinibixxi assorbiment mill-ġdid tal-għadam (riskju ogħla għal komposti potenti ħafna), mnejn jingħata (riskju ogħla għall-għoti parenterali) u d-doża kumulattiva ta' terapija għall-assorbiment mill-ġdid tal-għadam - Kanċer, kondizzjonijiet ko-morbużi (eż. anemija, disturbi fit-tagħqid tad-demm, infezzjoni), tipjip - Terapiji mogħtija fl-istess waqt: kortikosterojdi, kimoterapija, inibituri tal-anġjoġenesi, radjuterapija għar-ras u l-għonq - Iġjene orali fqira, mard fil-ħanek, dentaturi li ma jeħlux sew, storja ta' mard dentali, proċeduri dentali invażivi eż. qlugħ ta' snien.
English: Each film-coated tablet contains 0.86 mg lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 0.86 mg ta' lactose (bħala lactose monohydrate).
English: INFORMATION IN BRAILLE Ibandronic acid Sandoz 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ibandronic acid Sandoz 50 mg
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.
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: Ibandronic acid Sandoz tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Maltese: Pilloli Ibandronic acid Sandoz fihom lactose u m'għandhomx jingħataw lill-pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta' glucose-galactose.
English: When taken 30 minutes before a meal, the reduction in bioavailability is approximately 30%.
Maltese: Meta jittieħed 30 minuta qabel ikla, it-tnaqqis fil-bijodisponibilità hija ta' bejn wieħed u ieħor 30%.
English: - Patients should not lie down for 60 minutes after taking Ibandronic acid Sandoz.
Maltese: - Il-pazjenti m'għandhomx jimteddu għal 60 minuta wara li jkunu ħadu Ibandronic acid Sandoz.
English: As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Maltese: Bħall-bisfosfonati l-oħra, ilkilwa ġiet identifikata bħala l-organu primarju ta' tossiċità sistemika.
English: Macrogol 4000
Maltese: Lactose monohydrate Macrogol 4000
English: There was also a 38% reduction in the risk of developing an SRE for ibandronic acid treated patients when compared with placebo (relative risk 0.62, p=0.003).
Maltese: Kien hemm ukoll tnaqqis ta' 38 % firriskju ta' żvilupp ta' SRE għall-pazjenti kkurati b'Ibandronic acid Sandoz meta mqabbla mal-plaċebo (riskju relattiv 0.62, p=0.003).
English: Oesophagitis, abdominal pain, dyspepsia, nausea
Maltese: Esofaġite, uġigħ addominali, dispepsja, nawseja
English: Haemorrhage, duodenal ulcer, gastritis, dysphagia, dry mouth
Maltese: Emorraġija, ulċera duwodenali, gastrite, disfaġja, ħalq xott
English: The other ingredients are: - tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised,
Maltese: Is-sustanzi l-oħra huma: - qalba tal-pillola: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.
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 Sandoz 50 mg administered orally), and from post-marketing experience.
Maltese: III pivotali (Prevenzjoni ta' avvenimenti skeletali f'pazjenti b'kanċer tas-sider u b'metastasi tal-għadam: 286 pazjent ikkurati b'Ibandronic acid Sandoz 50 mg mogħti oralment), u minn esperjenza ta' wara t-tqegħid fis-suq.
English: Ibandronic acid Sandoz contains the active substance ibandronic acid.
Maltese: Ibandronic acid Sandoz fih is-sustanza attiva, ibandronic acid.
English: Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min.
Maltese: It-tneħħija totali ta' ibandronic acid hija baxxa b'livelli medji f'firxa ta' 84-160 mL/min.
English: Largo Umberto Boccioni, 1 I-21040 Origgio / VA Tel: +39 02 96541
Maltese: Origgio / VA Tel: +39 02 96541
English: ul.
Maltese: Str.
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'bejn wieħed u ieħor 75% meta pilloli ibandronic acid ingħataw sagħtejn wara ikla normali.
English: Ibandronic acid Sandoz contains lactose
Maltese: Ibandronic acid Sandoz fih lactose
English: Ibandronic acid Sandoz 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: Ibandronic acid Sandoz huwa indikat f'persuni adulti għall-prevenzjoni ta' avvenimenti skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl-għadam li jirrikjedu radjuterapija jew kirurġija) f'pazjenti b'kanċer tas-sider u metastasi fl-għadam.
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction 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 minħabba spostament mhux probabbli.
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Maltese: Bisphosphonates mogħtija b'mod orali jistgħu jikkawżaw irritazzjoni lokali tal-mukuża gastrointestinali ta' fuq.
English: S.C. Sandoz, S.R.L.
Maltese: Sandoz, S.R.L.
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: Mhux probabbli li jkun hemm interazzjonijiet metaboliċi minħabba li ibandronic acid ma jimpedixxix l-isoenzimi P450 epatiċi umani maġġuri u intwera li ma jinduċix is-sistema tas-cytochrome P450 epatiku fil-firien (ara sezzjoni 5.2).
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Maltese: Każijiet ta' reazzjoni anafilattika/xokk anafilattika, inkluż avvenimenti fatali, ġew irrapportati f'pazjenti kkurati b'ibandronic acid ġol-vini.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
Maltese: Għall-pazjenti 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 (are sezzjoni 4.2).
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Maltese: Ladarba Acetylsalicylic acid, prodotti mediċinali Anti-Infjammatorji Nonsterojdali (NSAIDs) u bifosfonati huma assoċjati ma' irritazzjoni gastro-intestinali, wieħed irid joqgħod attent meta jieħu dawn il-mediċini fl-istess ħin (ara sezzjoni 4.4).
English: • if you have kidney problems
Maltese: • jekk għandek problemi tal-kliewi
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with ibandronic acid.
Maltese: Madankollu, skont l-evalwazzjoni klinika tal-pazjent individwali, hu rakkomandat li funzjoni tal-kliewi, serum calcium, phosphate u magnesium għandhom jiġu mmonitorjati f'pazjenti kkurati b'ibandronic acid.
English: Water may be taken at any time during the course of Ibandronic acid Sandoz treatment (see section 4.5).
Maltese: Ilma jista' jittieħed fi kwalunkwe ħin matul il-kors ta' trattament ta' Ibandronic acid Sandoz (ara sezzjoni 4.5).
English: Verovškova 57
Maltese: Industriestr. 25
English: **See further information below †Identified in post-marketing experience.
Maltese: **Ara informazzjoni addizzjonali hawn taħt †Identifikata fl-esperjenza ta' wara t-tqegħid fis-suq.
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 tal-kliewi (CLcr  30 mL/min) li kienu qed jirċievu doża orali ta' 10 mg ibandronic acid kuljum għal 21 ġurnata, kellhom konċentrazzjonijiet ogħla fil-plażma, id-doppju jew it-triplu ta' individwi b'funzjoni normali tal-kliewi (CLcr ≥80 mL/min).
English: Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid.
Maltese: Avvenimenti ta' infjammazzjoni okulari bħal uveite, episklerite u sklerite ġew irrappurtati b'ibandronic acid.
English: Ibandronic acid Sandoz 50 mg film-coated tablets ibandronic acid
Maltese: Ibandronic acid Sandoz 50 mg pilloli miksija b'rita ibandronic acid
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).Treatment was most frequently associated with a decrease in serum calcium to below normal range (hypocalcaemia), followed by dyspepsia.
Maltese: L-aktar reazzjonijiet avversi serji rrapportati huma reazzjoni/xokk anafilattiku, ksur atipiku tal-wirk, osteonekrożi tax-xedaq, irritazzjoni gastrointestinali, u infjammazzjoni okulari (ara l-paragrafu “Deskrizzjoni ta' reazzjonijiet avversi magħżula” u sezzjoni 4.4).
English: Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronate sodium monohydrate).
Maltese: Kull pillola miksija b'rita fiha 50 mg ta' ibandronic acid (bħala ibandronate sodium monohydrate).
English: • After taking your tablet, wait at least 30 minutes.
Maltese: • Wara li tieħu l-pillola tiegħek, stenna mill-inqas 30 minut.