FrancophonIA/ELRC3.0 huggingface dataset:
English: INTEGRILIN-treated patients who had a prothrombin time (PT) > 14.5 seconds and received warfarin concomitantly did not appear to be at an increased risk of bleeding.
Maltese: Pazjenti kkurati b'INTEGRILIN li kellhom ħin ta' prothrombin (PT) ta' > 14.5 sekondi u li rċevew ukoll warfarin, ma dehrux li kienu f'riskju miżjud ta' fsada.
English: However, in a population pharmacokinetic study there was no evidence of a pharmacokinetic interaction between eptifibatide and the following concomitant medicinal products: amlodipine, atenolol, atropine, captopril, cefazolin,
Maltese: Madankollu, fi studju farmakokinetiku ta' popolazzjoni, ma kien hemm l-ebda evidenza ta' interazzjoni farmakokinetika bejn eptifibatide u l prodotti mediċinali li ġejjin li kienu qed jittieħdu flimkien: amlodipine, atenolol, atropine, captopril,
English: ESPRIT: This was a double-blind, multicentre, randomised, parallel-group, placebo-controlled trial evaluating the safety and efficacy of eptifibatide therapy in patients scheduled to undergo nonemergent percutaneous coronary intervention (PCI) with stent implantation.
Maltese: Din kienet prova double-blind, multicentre, randomised, b'parallel-group u kkontrollata bil plaċebo li evalwat is-sigurtà u l-effikaċja ta' terapija b'eptifibatide f'pazjenti li kellhom jagħmlu intervent koronarju perkutanju (PCI) mhux emerġenti b'impjantazzjoni ta' stent.
English: − hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: − sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi elenkati f'sezzjoni 6.1
English: Of the patients in PURSUIT, 13 % were managed with PCI during eptifibatide infusion, of whom approximately 50 % received intracoronary stents; 87 % were managed medically (without PCI during eptifibatide infusion).
Maltese: Mill-pazjenti ta' PURSUIT, 13 % kienu mmaniġġjati b'PCI waqt l-infużjoni ta' eptifibatide, li minnhom madwar 50 % irċivew stents intrakoronarji; 87 % kienu mmaniġġjati b'mod mediku (mingħajr PCI waqt linfużjoni ta' eptifibatide).
English: − raised cardiac enzymes or markers (e.g. CK-MB, troponins) and
Maltese: − żjieda fl-enzimi jew markaturi kardijaċi (eż. CK-MB, troponins) u
English: Marketing Authorisation Holder:
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: − if you have or have had bleeding problems.
Maltese: − jekk għandek jew kellek problemi ta' fsada.
English: No genotoxic effects were observed with eptifibatide.
Maltese: Ma kienu osservati l-ebda effetti ġenotossiċi b'eptifibatide.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection contains 2 mg of eptifibatide.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni għall-infużjoni fih 2 mg ta' eptifibatide.
English: At the highest infusion rates (1.3 microgram/kg/min and 2.0 microgram/kg/min) studied, eptifibatide was associated with an increased incidence of bleeding and transfusions compared to the incidence seen when streptokinase was given alone.
Maltese: (1.3 mikrogrammi/kg/min u 2.0 mikrogrammi/kg/min) studjati, eptifibatide kien assoċjat ma' inċidenza miżjuda ta' fsada u trasfużjonijiet meta mqabbel ma' l-inċidenza osservata meta streptokinase kien mogħti waħdu.
English: Physical and chemical compatibility testing indicate that INTEGRILIN may be administered through an intravenous line with atropine sulfate, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, tissue plasminogen activator, or verapamil.
Maltese: .6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema Testijiet fiżiċi u kimiċi dwar il-kompatibilità jindikaw li INTEGRILIN jista' jingħata minn linja għal ġol vini ma' atropine sulfate, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, attivatur ta' plażminoġen fit-tessut, jew verapamil.
English: In patients with moderate to severe renal insufficiency (creatinine clearance < 50 ml/min), the clearance of eptifibatide is reduced by approximately 50% and steady-state plasma levels are approximately doubled.
Maltese: F'pazjenti b'insuffiċjenza moderata sa severa tal-kliewi (tneħħija tal-krejatinina ta' < 50 ml/min), it-tneħħija ta' eptifibatide tonqos b'madwar 50% u l-livelli fil-plażma fi stat fiss ftit jew wisq jirduppjaw.
English: The incidence of severe or life threatening bleeding events with Integrilin was 1.9% compared to 1.1% with placebo.
Maltese: L-inċidenza ta' avvenimenti ta' fsada severa jew ta' periklu għall-ħajja b'Integrilin kienet ta' 1.9% meta mqabbel ma' 1.1% bil-plaċebo.
English: What Integrilin looks like and contents of the pack Integrilin solution for injection: 10 ml vial, pack of one vial.
Maltese: Integrilin soluzzjoni għall-injezzjoni: kunjett ta' 10 ml, pakkett ta' kunjett wieħed.
English: Because INTEGRILIN inhibits platelet aggregation, caution must be employed when it is used with other medicinal products that affect haemostasis, including ticlopidine, clopidogrel, thrombolytics, oral anticoagulants, dextran solutions, adenosine, sulfinpyrazone, prostacyclin, non-steroidal antiinflammatory agents, or dypyridamole (see section 4.5).
Maltese: mediċini li jittieħdu mill-ħalq kontra il-koagulazzjoni, soluzzjonijiet ta' dextran, adenosine, sulfinpyrazone, prostacycline, sustanzi anti-infjammatorji mhux sterojdi, jew dipyridamole (ara sezzjoni
English: Early routine eptifibatide in this high-risk NSTE-ACS optimally-treated population who were managed with an invasive strategy did not result in a statistically significant reduction in the composite primary endpoint of rate of death, MI, RI-UR, and TBO within 96 hours compared with a regimen of delayed provisional eptifibatide (9.3% in early eptifibatide patients vs. 10.0% in patients assigned to delayed provisional eptifibatide; odds ratio=0.920; 95% CI=0.802-1.055; p=0.234).
Maltese: Għoti bikri ta' eptifibatide bħala rutina f'din il-popolazzjoni NSTE-ACS b'riskju għoli u kkurata bl-aħjar mod li kienu mmaniġġati bi strateġija invażiva ma wassalx għal tnaqqis sinifikanti b'mod statistiku fl iskop primarju kompost fl-aħħar tal-istudju ta' rata ta' mewt, MI, RI-UR, u TBO fi żmien 96 siegħa meta mqabbel ma' skeda ta' għoti provviżorju mdewwem ta' eptifibatide (9.3% f'pazjenti b'għoti bikri ta' eptifibatide vs. 10.
English: According to epidemiological findings, a higher incidence of cardiovascular events has been associated with certain indicators, for instance:
Maltese: Skond is-sejbiet epidemjoloġiċi, inċidenza ogħla ta' avvenimenti kardjovaskulari kienet assoċjata ma' ċerti indikaturi, per eżempju:
English: Hepatic impairment
Maltese: Disturbi Vaskulari
English: Since either repeat exposure with any GP IIb/IIIa ligand-mimetic agent (like abciximab or eptifibatide) or first-time exposure to a GP IIb/IIIa inhibitor may be associated with immune-mediated thrombocytopenic responses, monitoring is required, i.e. platelet counts should be monitored prior to treatment, within 6 hours of administration, and at least once daily thereafter while on therapy and immediately at clinical signs of unexpected bleeding tendency.
Maltese: Peress li esponiment ripetut għal kwalunkwe sustanza li timmimika l-ligand GP IIb/IIIa (bħal abciximab jew eptifibatide) jew espożizzjoni għall-ewwel darba għall-inibitur ta' GP IIb/IIIa jista' jkun assoċjat ma' risponsi tromboċitopeniċi medjati mill-immunità, sorveljanza hija meħtieġa, i.e. l-għadd tal-plejtlits għandhom jiġu ssorveljati qabel il-kura, fi żmien 6 sigħat mill-għoti, u wara dan mill-inqas darba kuljum waqt it-terapija u minnufih meta jkun hemm sinjali kliniċi ta' tendenza ta' fsada mhux mistennija.
English: INTEGRILIN is intended for use with acetylsalicylic acid and unfractionated heparin.
Maltese: INTEGRILIN huwa maħsub għall-użu flimkien ma' acetylsalicylic acid u heparin mhux frazzjonat.
English: The ESPRIT trial used a simplified regimen of heparin during PCI that consisted of an initial bolus of 60 units/kg, with a target ACT of 200 - 300 seconds.
Maltese: 60 unità/kg, b'targit ta' ACT ta' 200 - 300 sekonda.
English: There was no excessive bleeding in any of these patients, although one patient undergoing CABG surgery was reported as having had a moderate bleed.
Maltese: CABG kien irrappurtat li kellu fsada moderata.
English: Uncommon Thrombocytopenia.
Maltese: Tromboċitopenija.
English: In the subgroup of patients undergoing PCI, major bleeding was observed commonly, in 9.7 % of Integrilin-treated patients vs. 4.6 % of placebo-treated patients.
Maltese: Fis-sottogrupp ta' pazjenti li għamlu PCI, fsada maġġuri kienet osservata b'mod komuni, f'9.7 % tal-pazjenti kkurati b'Integrilin vs.
English: In patients with moderate renal impairment (creatinine clearance ≥ 30 - < 50 ml/min), an intravenous bolus of 180 microgram/kg should be administered followed by a continuous infusion dose of 1.0 microgram/kg/min for the duration of therapy.
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-krejatinina ta' ≥ 30 - < 50 ml/min), għandu jingħata bolus fil-vini ta' 180 mikrogramma/kg segwit minn doża ta' infużjoni kontinwa ta'
English: GUSTO moderate or severe/life threatening bleeding occurred significantly more often with early routine eptifibatide (7.4% vs. 5.0% in delayed provisional eptifibatide group; p <0.001).
Maltese: Fsada GUSTO moderata jew qawwija/ta' periklu għall-ħajja seħħet b'mod sinifikanti aktar ta' spiss b'għoti bikri ta' eptifibatide bħala rutina (7.4% vs. 5.0% fil-grupp ta' għoti provviżorju mdewwem ta' eptifibatide;
English: Discontinue unfractionated heparin.
Maltese: Ilma għall-injezzjonijiet
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 0.75 mg/ml solution for infusion
Maltese: INTEGRILIN 0.75 mg/ml, soluzzjoni għall-infużjoni
English: − age
Maltese: A.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01.07.1999
Maltese: Data ta' l-ewwel awtorizzazzjoni: 01.07.1999 Data ta' l-aħħar tiġdid: 09.07.2009
English: MI was identified per the CK-MB core laboratory criteria.
Maltese: MI kien identifikat skond il-kriterji prinċipali tal-laboratorju ta' CK-MB. Għal din id-dijanjosi, fi żmien
English: In patients with severe renal impairment (creatinine clearance <30mL/min) administered 1microgram/kg/min , 80% inhibition was achieved in more than 80% of patients at 24 hours.
Maltese: F'pazjenti b'indeboliment renali sever (tneħħija talkrejatinina < 30mL/min) li ngħataw 1 ug/kg/min, inkisbet inibizzjoni ta' 80% f'aktar minn 80% tal pazjenti fi żmien 24 siegħa.
English: − clinically significant hepatic impairment
Maltese: − indeboliment tal-fwied ta' sinifikanza klinika
English: In the same population, plasma elimination half-life is approximately 2.5 hours, plasma clearance 55 to 80 ml/kg/hr and volume of distribution of approximately 185 to 260 ml/kg.
Maltese: 80 ml/kg/kull siegħa u l-volum ta' distribuzzjoni ta' madwar 185 sa 260 ml/kg.
English: Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis).
Maltese: kuljum sa 72 mg/kg/kuljum (madwar 4 darbiet aktar mid-doża massima ta' kuljum rrakkomandata għall bnedmin fuq bażi ta' l-erja tas-superfiċje tal-ġisem) u fi fniek tqal b'dożi totali ta' kuljum sa
English: The expiry date refers to the last day of that month.
Maltese: Il-waqfien tat-treddigħ waqt il-perijodu ta' kura huwa rrakkomandat.
English: How to store Integrilin
Maltese: X'fih Integrilin
English: Eptifibatide inhibits platelet aggregation in a dose- and concentration-dependent manner as demonstrated by ex vivo platelet aggregation using adenosine diphosphate (ADP) and other agonists to induce platelet aggregation.
Maltese: Eptifibatide jimpedixxi l-aggregazzjoni tal-plejtlits b'mod li jiddependi mid-doża u mill-konċentrazzjoni kif intwera minn aggregazzjoni tal-plejtlits ex vivo bl-użu ta' adenosine diphosphate (ADP) u agonisti oħra biex tkun kkaġunata l-aggregazzjoni tal-plejtlits.
English: If percutaneous coronary intervention (PCI) is performed during Integrilin therapy, the intravenous solution may be continued for up to 96 hours.
Maltese: Jekk isir intervent koronarju perkutanju (PCI) matul it-terapija b'Integrilin, is-soluzzjoni fil-vini għandha mnejn titkompla sa 96 siegħa.
English: DL12 8DT
Maltese: Durham, DL12 8DT, Ir-Renju Unit
English: Batch
Maltese: Fsada
English: Very common Bleeding (major and minor bleeding including femoral artery access, CABG
Maltese: Komuni ħafna Fsada (fsada maġġuri u minuri inkluż aċċess ta' l-arterja femorali, konnessa ma'
English: It should be administered by specialist physicians experienced in the management of acute coronary syndromes.
Maltese: Għandu jingħata minn tobba speċjalisti b'esperjenza flimmaniġġjar ta' sindromi koronarji akuti.
English: EARLY-ACS trial
Maltese: NUMRU TAL-LOTT Lot
English: The pharmacokinetics of eptifibatide are linear and dose proportional for bolus doses ranging from 90 to 250 microgram/kg and infusion rates from 0.5 to 3.0 microgram/kg/min.
Maltese: 90 sa 250 mikrogramma/kg u rati ta' infużjoni minn 0.5 sa 3.0 mikrogrammi/kg/min.
English: INTEGRILIN is an antithrombotic agent that acts by inhibition of platelet aggregation; therefore the patient must be observed carefully for indications of bleeding during treatment (see section 4.8).
Maltese: B'għoti wara t-tqegħid fis-suq ta' eptifibatide kienet osservata tromboċitopenija, inkluż tromboċitopenija akuta profonda (ara sezzjoni 4.8).
English: Anaphylactic reactions.
Maltese: Reazzjonijiet anafilattiċi.
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 2 mg/ml solution for injection
Maltese: INTEGRILIN 2 mg/ml soluzzjoni għall-injezzjoni
English: Results on the primary endpoint were principally attributed to the occurrence of myocardial infarction.
Maltese: Ir-riżultati fuq il-punt finali primarju kienu prinċipalment attribwiti għall-okkorrenza ta' infart mijokardijaku.
English: If the platelet count falls below 100,000/mm3, further platelet counts are required to rule out pseudothrombocytopenia.
Maltese: Jekk l għadd tal-plejtlits jaqa' taħt 100,000/mm3, għadd tal-plejtlits addizzjonali huma meħtieġa biex tkun eskluża l-possibbiltà ta' psewdotromboċitopenija.
English: If PCI is to be performed in the setting of UA/NQMI, monitor the activated clotting time (ACT) to maintain a value between 300-350 seconds.
Maltese: Jekk il-PCI se ssir fl-ambjent ta' UA/NQMI, osserva l-ħin ta' tagħqid tad-demm attivat (ACT) biex jinżamm valur ta' bejn 300-350 sekondi.
English: How to use Integrilin
Maltese: X'għandek tkun taf qabel ma tingħata Integrilin
English: Co. Durham
Maltese: U L-UŻU
English: Integrilin is given into the vein by direct injection followed by an infusion (drip solution).
Maltese: Integrilin jingħata fill-vini b'injezzjoni diretta segwita minn infużjoni (soluzzjoni likwida bid-dripp).
English: While Thrombolysis in Myocardial Infarction TIMI bleeding criteria were used to categorize the incidence of major and minor bleeding in both the PURSUIT and the ESPRIT trials, PURSUIT data was collected within 30 days while ESPRIT data was limited to events within 48 hours or discharge, whichever came first.
Maltese: Filwaqt li kemm fil-prova PURSUIT kif ukoll f'ESPRIT intuża kriterju ta' fsada ta' Trombolisi f'Infart Mijokardijaku TIMI biex tiġi kklassifikata l-inċidenza ta' fsada maġġuri u minuri, tagħrif minn PURSUIT inġabar fi żmien 30 ġurnata waqt li tagħrif minn ESPRIT kien limitat għal avvenimenti li seħħew fi żmien 48 siegħa jew sa meta lpazjenti ħarġu mill-isptar, skond liema seħħ l-ewwel.
English: − major surgery or severe trauma within past 6 weeks
Maltese: − operazzjoni serja jew trawma severa matul l-aħħar 6 ġimgħat
English: Each ml of solution for injection contains 2 mg of eptifibatide.
Maltese: Kull ml ta' soluzzjoni għall-infużjoni fih 2 mg ta' eptifibatide.
English: The effect of eptifibatide is observed immediately after administration of a 180 microgram/kg intravenous bolus.
Maltese: L-effett ta' eptifibatide huwa osservat immedjatament wara l-għoti ta' bolus fil-vini ta' 180 mikrogramma/kg.
English: If PCI was performed, the eptifibatide infusion was continued for 24 hours after the procedure, allowing for a duration of infusion up to 96 hours.
Maltese: Jekk saret PCI, l-infużjoni ta' eptifibatide tkompliet għal 24 siegħa wara l-proċedura, u dan jippermetti tul ta' l-infużjoni sa 96 siegħa.
English: Thrombocytopenia and Immunogencity related to GP IIb/IIIa inhibitors INTEGRILIN inhibits platelet aggregation, but does not appear to affect the viability of platelets.
Maltese: INTEGRILIN jimpedixxi l-aggregazzjoni tal-plejtlits, iżda ma jidhirx li jaffettwa l-vijabilità tal-plejtlits.
English: Integrilin is an inhibitor of platelet aggregation.
Maltese: X'inhu Integrilin u gћalxiex jintuża Integrilin huwa impeditur ta' l-aggregazzjoni tal-plejtlits.
English: For a 2.0 microgram/kg/min infusion, mean steady-state plasma eptifibatide concentrations range from 1.5 to 2.2 microgram/ml in patients with coronary artery disease.
Maltese: 1.5 sa 2.2 mikrogrammi/ml f'pazjenti b'mard ta' l-arterja koronarja.
English: The full EPAR for Iasibon can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Iasibon jista' jinstab fuq is-sit web tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Iasibon is a ‘generic medicine'.
Maltese: Iasibon huwa ‘mediċina ġenerika'.
English: Iasibon ibandronic acid
Maltese: Iasibon aċidu ibandroniku
English: The active substance in Iasibon, ibandronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Iasibon, l-aċidu ibandroniku, hija l-bisfosfonat.
English: This is a summary of the European public assessment report (EPAR) for Iasibon.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Iasibon.
English: In the prevention of skeletal events, Iasibon is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day.
Maltese: Fil-prevenzjoni ta' avvenimenti skeletriċi, Iasibon jew jingħata bħala infużjoni ta' 6-mg li ddum millinqas 15-il minuta kull tlieta sa erba' ġimgħat, jew bħala pillola darba kuljum.
English: Why has Iasibon been approved?
Maltese: Għaliex ġie approvat Iasibon?
English: Other information about Iasibon
Maltese: Informazzjoni oħra dwar Iasibon
English: This means that Iasibon is similar to a ‘reference medicine' already authorised in the European Union (EU) called Bondronat.
Maltese: Dan ifisser li Iasibon huwa simili għal ‘mediċina ta' referenza' msejħa Bondronat li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: What is Iasibon?
Maltese: X'inhu Iasibon?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Iasibon on 21 January 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Iasibon valida fl-Unjoni Ewropea kollha fil-21 ta' Jannar 2011.
English: Because Iasibon is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Bondronat.
Maltese: Minħabba li Iasibon huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet sabiex tkun iddeterminata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Bondronat.
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein) and as tablets (50 mg).
Maltese: Jiġi f'konċentrat li jissawwar f'soluzzjoni li tingħata b'infużjoni (dripp fil-vina) u jiġi wkoll f'pilloli (50 mg).
English: Because Iasibon is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Iasibon huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The CHMP concluded that, in accordance with EU requirements, Iasibon has been shown to have comparable quality and to be bioequivalent to Bondronat.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Iasibon intwera li għandu kwalità li tixbah lil dik ta' Bondronat u li huwa bijoekwivalenti.
English: They must be taken with a full glass of plain water (in areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content should be used).
Maltese: Iridu jittieħdu ma' tazza mimlija bl-ilma minerali (f'żoni fejn ikun hemm ilma aħrax, jiġifieri fejn l-ilma tal-vit ikun fih ħafna kaljċu maħlul, għandu jintuża ilma tal-flixkun b'kontenut minerali baxx).
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, l-opinjoni tas-CHMP kienet li, bħal fil-każ ta' Bondronat, il-benefiċċju huwa akbar mir-riskju identifikat.
English: A risk management plan has been developed to ensure that Iasibon is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżigura li Iasibon jintuża bl-aktar mod sigur possibbli.
English: The infusion will normally bring the blood calcium level down to normal levels within a week.
Maltese: L-infużjoni normalment tniżżel il-livell tal-kalċju fid-demm għal-livelli normali fi żmien ġimgħa.
English: What are the benefits and risks of Iasibon?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Iasibon?
English: Iasibon is a medicine that contains the active substance ibandronic acid.
Maltese: Iasibon huwa mediċina li fih is-sustanza attiva aċidu ibandroniku.
English: In the treatment of hypercalcaemia caused by tumours, Iasibon is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is.
Maltese: Fil-kura tal-iperkalċimija kkawżata minn tumuri, Iasibon jingħata b‘infużjoni kemm ta' 2mg jew ta' 4 mg tul sagħtejn, dejjem skont kemm tkun gravi l-iperkalċimija.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Iasibon, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Abbażi ta' dan il-pjan, fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Iasibon, inklużi l-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti tal-kura tas-saħħa u l-pazjenti.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Maltese: Hija twaqqaf l-azzjoni talosteoklastiċi, iċ-ċelloli fil-ġisem li huma involuti fit-tkissir tat-tessut tal-għadam.
English: The concerned Member States (CMS) are: CZ, DE, ES, IT, NL, PL and UK.
Maltese: CZ, DE, ES, IT, NL, PL u UK.
English: 1 Armenian S.H., Hudson M.M., Mulder R.L., Chen M.H., Constine L.S., et al. ‘Recommendations for Cardiomyopathy Surveillance for Survivors of Childhood Cancer: A Report from the International Late Effects of Childhood Cancer Guideline Harmonization Group' Lancet Oncology, Vol. 16(3), March 2015, p. e123-e136
Maltese: 1 Armenian S.H., Hudson M.M., Mulder R.L., Chen M.H., Constine L.S., et al. ‘Recommendations for Cardiomyopathy Surveillance for Survivors of Childhood Cancer: A Report from the International Late Effects of Childhood Cancer Guideline Harmonization Group' Lancet Oncology, Vol. 16(3), Marzu 2015, p. e123-e136
English: The mutual recognition procedure FR/H/0283/001/II/27G started on 28/11/2015.
Maltese: Il-proċedura ta' rikonoxximent reċiproku FR/H/0283/001/II/27G bdiet fit-28/11/2015.
English: The reference Member State (RMS) is: FR
Maltese: L-Istat Membru ta' referenza (RMS) huwa:
English: The CMDh 60 day procedure was initiated on 02/12/2016.
Maltese: Il-proċedura ta' 60 jum tas-CMDh tnediet fit-02/12/2016.
English: Scientific conclusions
Maltese: FR
English: • removal of the contraindication in children and adolescents
Maltese: • tneħħija tal-kontraindikazzjoni fit-tfal u fl-adolexxenti