FrancophonIA/ELRC3.0 huggingface dataset:
English: Agents such as carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort are strong inducers of CYP3A4/5 and may decrease composite exposure of the active drug substances, temsirolimus and its metabolite, sirolimus.
Maltese: Għalhekk, il-kura fl-istess ħin b'mediċini li għandhom potenzjal li jinduċu CYP3A4/5 (eż. carbamazepine, phenobarbital, phenytoin, rifampicin, u St.
English: 100% of planned dose
Maltese: 100% tad-doża ppjanata
English: Temsirolimus elimination by the kidneys is negligible; studies in patients with varying renal impairment have not been conducted (see sections 4.2 and 5.2).
Maltese: It-tneħħija ta' temsirolimus mill-kliewi hi negliġibbli; ma sarux studji f'pazjenti b'indeboliment renali li jvarja (ara sezzjoni 4.2 u 5.2).
English: All grades n (%)
Maltese: Il-gradi kollha n (%)
English: Torisel is a concentrate and solvent for solution for infusion.
Maltese: Torisel hu konċentrat u solvent għal soluzzjoni għall-infużjoni.
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna):
English: Serious adverse reactions observed in clinical trials of temsirolimus for advanced RCC, but not in clinical trials of temsirolimus for MCL include: anaphylaxis, impaired wound healing, renal failure with fatal outcomes, and pulmonary embolism.
Maltese: Ir-reazzjonijiet avversi serji li kienu osservati fil-provi kliniċi b'temsirolimus għal RCC avanzata, iżda mhux fil-provi kliniċi b'temsirolimus għal MCL jinkludu: anafilassi, indeboliment fil-fejqan tal-feriti, insuffiċjenza renali b'eżiti fatali, u emboliżu pulmonari.
English: The starting dose of 175 mg was associated with a significant incidence of adverse events and required dose reductions/delays in the majority of patients.
Maltese: Id-doża tal-bidu ta' 175 mg kienet assoċjata ma' inċidenza sinifikanti ta' avvenimenti avversi u kienet teħtieġ tnaqqis/dewmien fid-doża fil-maġġoranza tal-pazjenti.
English: Torisel may cause non-specific interstitial pneumonitis.
Maltese: Torisel jista' jikkawża pulmonite interstizjali mhux speċifika.
English: Platelets
Maltese: LISTA
English: The concentrate- solvent mixture is stable below 25°C for up to 24 hours.
Maltese: It-taħlita tal-konċentrat-solvent hi stabbli sa 24 siegħa f'temperatura taħt il-25C.
English: In Part 2, 45 patients aged from 1 to 17 years with recurrent/relapsed rhabdomyosarcoma, neuroblastoma, or high grade glioma were administered temsirolimus at a weekly dose of 75 mg/m2.
Maltese: F'Parti 2, 45 pazjent li kellhom minn sena sa 17-il sena u li kellhom rabdomijosarkoma rikorrenti/li tirkadi, newroblastoma, jew glijoma ta' grad għoli, ingħataw temsirolimus f'doża ta' darba fil-ġimgħa ta' 75 mg/m2.
English: In rats, these changes were accompanied by a decreased weight of accessory sex organs (epididymides, prostate, seminal vesicles).
Maltese: Fil-firien, dawn it-tibdiliet kienu akkumpanjati minn tnaqqis fil-piż ta' l-organi sesswali aċċessorji (epididimu, prostata, vexxikuli seminali).
English: Temsirolimus is a selective inhibitor of the enzyme mTOR (mammalian target of rapamycin) that blocks tumour cell growth and division.
Maltese: Temsirolimus hu inibitur selettiv tal-enzim mTOR (mira mammifera ta' rapamycin) li jimblokka ttkabbir u l-qsim taċ-ċelluli tat-tumuri.
English: Therefore, concomitant treatment with agents that have CYP3A4/5 induction potential should be avoided (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort) (see section 4.4).
Maltese: Mediċini bħal carbamazepine, phenobarbital, phenytoin, rifampicin u St.
English: 50 x 109/l
Maltese: 50 x 10
English: Temsirolimus has been associated with phospholipidosis in rats.
Maltese: Temsirolimus kien assoċjat ma' fosfolipidosi fil-firien.
English: Cytotoxic
Maltese: Ipofosfatimija
English: Hypersensitivity reactions / drug hypersensitiviy
Maltese: Reazzjonijiet ta' sensittività eċċessiva / sensittività eċċessiva għall-mediċina
English: Hazard ratio (97.5% CI)a
Maltese: Xhur (95% CI)
English: You may be at risk of getting an infection of the blood, skin, upper respiratory tract (including pneumonia), and/or urinary tract while you are taking Torisel.
Maltese: Tista' tkun f'riskju li taqbdek infezzjoni fid-demm, fil-ġilda, fil-parti ta' fuq tal-apparat respiratorju (inkluża pnewmonja), u/jew fl-apparat urinarju waqt li tkun qed tieħu Torisel.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil tal-benefiċċjuu r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: One vial of Torisel concentrate contains 30 mg of temsirolimus: when the 1.2 ml concentrate is combined with 1.8 ml of the supplied solvent, a total volume of 3.0 ml is obtained, and the concentration of temsirolimus will be 10 mg/ml.
Maltese: Kunjett wieħed ta' konċentrat ta' Torisel fih 30 mg ta' temsirolimus: meta 1.2 ml tal-konċentrat jitħallat ma' 1.8 ml tas-solvent fornut, jinkiseb volum totali ta' 3.0 ml, u l-konċentrazzjoni ta' temsirolimus ser tkun ta' 10 mg/ml.
English: The admixture of Torisel in sodium chloride 9 mg/ml (0.9%) solution for injection should be protected from excessive room light and sunlight.
Maltese: It-taħlita ta' Torisel f'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni, għandha tkun protetta minn dawl eċċessiv tal-kamra jew tax-xemx.
English: Treatment of suspected adverse reactions may require temporary interruption and/or dose reduction of temsirolimus therapy.
Maltese: Il-kura ta' reazzjonijiet avversi ssuspettati jista' jkollhom bżonn ta' interruzzjoni temporanja u/jew tnaqqis tad-doża fit-terapija ta' temsirolimus.
English: STEP 2: ADMINISTRATION OF CONCENTRATE FOR SOLUTION FOR INFUSION SOLVENT MIXTURE IN SODIUM CHLORIDE 9 MG/ML (0.9%) SOLUTION FOR INJECTION
Maltese: TAL-KONĊENTRAT GĦAL SOLUZZJONI GĦALLINFUŻJONI SOLVENT F'SOLUZZJONI GĦALL-INJEZZJONI TA' SODIUM CHLORIDE 9 MG/ML (0.9%)
English: Uncommon Impaired wound healing
Maltese: Komuni ħafna Dardir Dijarea
English: Paresthaesia
Maltese: Disfaġja
English: The recommended dosing regimen of temsirolimus for MCL is 175 mg, infused over a 30-60 minute period once a week for 3 weeks followed by weekly doses of 75 mg, infused over a 30-60 minute period.
Maltese: Il-kors rakkomandat tad-dożaġġ ta' temsirolimus għal MCL hu ta' 175 mg, li jingħata bħala infużjoni fuq perjodu ta' 30-60 minuta darba fil-ġimgħa għal 3 ġimgħat, segwita minn dożi ta' kull ġimgħa ta' 75 mg, li jingħataw bħala infużjoni fuq perjodu ta' 30-60 minuta.
English: • Administration of the final diluted solution should be completed within six hours from the time that the Torisel is first added to sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: • L-għoti tas-soluzzjoni dilwita finali għandha titlesta fi żmien sitt sigħat mill-ħin li Torisel lewwel ikun żdied ma' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: How to store Torisel
Maltese: X'fih Torisel
English: Myalgia
Maltese: Pożoloġija
English: The infusion may then be resumed at a slower rate (up to 60 minutes) and should be completed within six hours from the time that temsirolimus is first added to sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: L-infużjoni tista' mbagħad titkompla b'rata inqas mgħaġġla (sa 60 minuta) u għandha titlesta fi żmien sitt sigħat mill-ħin li temsirolimus ikun żdied għall-ewwel darba ma' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għallinjezzjoni.
English: Gastrointestinal haemorrhage (including anal, rectal, haemorrhoidal, lip, and mouth haemorrhage, gingival bleeding)
Maltese: Emorraġija gastro-intestinali (li tinkludi emorraġija mill-anus, mirrektum, mill-murliti, mix-xofftejn, u mill-ħalq, fsada mill-ħanek) Gastrite **
English: if your blood levels of cholesterol and triglycerides have increased.
Maltese: - jekk għandek jew kellek livelli għoljin ta' kolesterol.
English: The fatal events included those due to progression of disease; however a causal relationship cannot be excluded.
Maltese: L-avvenimenti fatali inkludew dawk dovuti għall-progressjoni tal-marda; madankollu ma tistax tiġi eskluża relazzjoni kawżali.
English: Temsirolimus dose modifications based on weekly ANC and platelet counts ANC
Maltese: Tibdil fid-doża ta' temsirolimus ibbażat fuq l-għadd tal-ANC u plejtlits kull ġimgħa ANC
English: The occurrence of undesirable effects following the dose of 175 mg temsirolimus/week for MCL, e.g. Grade 3 or 4 infections or thrombocytopenia, is associated with a higher incidence than that observed with either 75 mg temsirolimus/week or conventional chemotherapy.
Maltese: Is-seħħ ta' effetti mhux mixtieqa wara d-doża ta' 175 mg ta' temsirolimus/ġimgħa għal MCL, eż. infezzjonijiet ta' Grad 3 jew 4 jew tromboċitopenija, huwa assoċjat ma' inċidenza ogħla minn dik osservata b'75 mg temsirolimus/ġimgħa jew b'kimoterapija konvenzjonali.
English: The concentrate-solvent mixture may only be administered in sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: It-taħlita ta' konċentrat-solvent tista' tingħata biss f'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: High concentrations resulted in complete cell growth inhibition in vitro, whereas inhibition mediated by FKBP-12/temsirolimus complex alone resulted in approximately 50% decrease in cell proliferation.
Maltese: Konċentrazzjonijiet għolja rriżultaw f'inibizzjonii sħiħa tat-tkabbir taċ-ċelluli in vitro, filwaqt li inibizzjoni medjata mill-kumpless FKBP-12/temsirolimus waħdu rriżultat fi tnaqqis ta' madwar 50% fil-proliferazzjoni taċ-ċelluli.
English: The required amount of concentrate--solvent mixture from each vial must be combined in one syringe for rapid injection into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2).
Maltese: L-ammont meħtieġ tat-taħlita ta' konċentrat-solvent minn kull kunjett irid jitħallat f'siringa waħda għal injezzjoni malajr ġo 250 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni (ara sezzjoni 4.2).
English: Concentrate
Maltese: Konċentrat
English: if you have mantle cell lymphoma and liver problems.
Maltese: - jekk għandek limfoma taċ-ċelluli mantle u problemi tal-fwied.
English: Temsirolimus should be used with caution in patients with severe renal impairment (see section 4.4).
Maltese: Temsirolimus għandu jintuża b'attenzjoni f'pazjenti b'indeboliment renali sever (ara sezzjoni 4.4).
English: if you are over 65 years of age.
Maltese: - jekk għandek iktar minn 65 sena.
English: Treatment with the combination of temsirolimus and IFN-α resulted in a statistically significant increase in the incidence of certain Grade 3-4 adverse events (weight loss, anaemia, neutropenia, thrombocytopenia and mucosal inflammation) when compared to the adverse events observed in the IFN-α or temsirolimus-alone arms.
Maltese: Il-kura bil-kumbinazzjoni ta' temsirolimus u IFN-α irriżultat f'żieda statistikament sinifikanti fl-inċidenza ta' ċerti avvenimenti avversi ta' Grad 3-4 (telf ta' piż, anemija, newtropenja, tromboċitopenja u infjammazzjoni mukuża) meta mqabbla mal-avvenimenti avversi osservati filpartijiet ta' l-istudju ta' IFN-α jew ta' temsirolimus waħidhom.
English: One vial of Torisel concentrate contains 30 mg of temsirolimus: when the 1.2 ml concentrate is combined with 1.8 ml of the supplied solvent, a total volume of 3.0 ml is obtained and the concentration of temsirolimus will be 10 mg/ml.
Maltese: Dejjem iddilwi l-konċentrat Torisel 30 mg b'1.8 ml tas-solvent fornut qabel ma żżidu massoluzzjonijiet għall-infużjoni.
English: Torisel, when diluted, contains polysorbate 80 and therefore appropriate administration materials must be used (see sections 6.1 and 6.2).
Maltese: Torisel, meta dilwit, ikun fih polysorbate-80 u għalhekk għandu jintuża materjal tal-amministrazzjoni xieraq (ara sezzjonijiet 6.1 u 6.2).
English: In an open-label, dose-escalation Phase 1 study in 110 subjects with advanced malignancies and either normal or impaired hepatic function, concentrations of temsirolimus and its metabolite sirolimus were increased in patients with elevated aspartate aminotransferase (AST) or bilirubin levels.
Maltese: Fi studju ta' fażi I, open label li fih id-doża tiżdied, li sar fuq 110 suġġetti li kellhom tumuri malinni fi stat avvanzat u jew funzjoni normali jew indebolita tal-fwied, il-konċentrazzjonijiet ta' temsirolimus u tal-metabolit tiegħu sirolimus żdiedu f'pazjenti b'livelli ta' aspartate aminotransferase (AST) jew ta' bilirubin għoljin.
English: Abdominal pain
Maltese: Emboliżmu fil-pulmun
English: Cataracts have been observed in some patients who received the combination of temsirolimus and interferon-α (IFN-α).
Maltese: Il-katarretti kienu osservati f'xi pazjenti li rċivew il-kumbinazzjoni ta' temsirolimus u interferon- (IFN-α).
English: Abdominal distension
Maltese: Nefħa addominali
English: In a Phase 1/2 study, 71 patients (59 patients, aged from 1 to 17 years old, and 12 patients, aged 18 to 21 years) were administered temsirolimus at doses ranging from 10 mg/m2 to 150 mg/m2 (see section 5.1).
Maltese: Fi studju ta' Fażi 1/2, 71 pazjent (59 pazjent, li kellhom minn sena sa 17-il sena, u 12-il pazjent, li kellhom minn 18 sa 21 sena) ingħataw temsirolimus f'dożi li kienu jvarjaw minn 10 mg/m2 sa
English: Interstitial lung disease
Maltese: TAL-PRODOTT MEDIĊINALI
English: Dose reduction levels
Maltese: Livelli għat-tnaqqis tad-doża
English: Each vial of 1.2 ml of concentrate for solution for infusion contains 30 mg temsirolimus.
Maltese: Kull kunjett ta' 1.2 ml ta' konċentrat għal soluzzjoni għall-infużjoni fih 30 mg ta' temsirolimus.
English: Pain
Maltese: Tilqim
English: The use of both an in-line and end-filter is not recommended.
Maltese: L-użu kemm ta' in-line kief ukoll ta' end-filter mhuwiex rakkomandat.
English: For patients with RCC and severe hepatic impairment, the recommended dose for patients who have baseline platelets 100 x 109/l is 10 mg intravenous once a week infused over a 30-60 minute period (see section 5.2).
Maltese: 9/l hi ta' 10 mg ġol-vini darba fil-ġimgħa mogħtija bħala infużjoni fuq perjodu ta' 30-60 minuta (ara sezzjoni 5.2).
English: The vial of concentrate must first be diluted with 1.8 ml of the supplied solvent to achieve a concentration of temsirolimus of 10 mg/ml.
Maltese: Wara l-ewwel dilwizzjoni tal-konċentrat b'1.8 ml tas-solvent fornut, il-konċentrazzjoni ta' temsirolimus tkun ta' 10 mg/ml.
English: Sulfate or glucuronide conjugates were not detected in the human faecal samples, suggesting that sulfation and glucuronidation do not appear to be major pathways involved in the excretion of temsirolimus.
Maltese: Konjugati ta' sulfate jew glucuronide ma kinux osservati f'kampjuni ta' ppurgar uman, u dan jissuġġerixxi li sulfation u glukoronidazzjoni ma jidhrux li huma passaġġi maġġuri involuti fit-tneħħija ta' temsirolimus.
English: Some patients were asymptomatic or had minimal symptoms with pneumonitis detected on computed tomography scan or chest radiograph.
Maltese: Xi pazjenti kienu asintomatiċi jew kellhom sintomi minimi bil-pnewmonite li kienet osservata fuq computed tomography scan jew radjografija tas-sider.
English: Your doctor may prescribe you insulin and/or oral antidiabetic agent therapy.
Maltese: Dan jista' jirriżulta fil-ħtieġa għall-insulina u/jew ta' terapija orali b'sustanza kontra d-dijabete.
English: Ageusia
Maltese: Stitikezza
English: The following effects were reported in mice and/or rats in the carcinogenicity studies conducted: granulocytic leukaemia, lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.
Maltese: L-effetti li ġejjin kienu rrappurtati fil-ġrieden u/jew fil-firien fl-istudji li saru dwar il-karċinoġeneċità: lewkimja granuloċitika, limfoma, adenoma epatoċellulari u karċinoma epatoċellulari, u adenoma testikulari.
English: This medicinal product must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Maltese: Dan il-prodott mediċinali għandu jingħata biss taħt is-superviżjoni ta' tabib b'esperjenza fl-użu ta' prodotti mediċinali antineoplastiċi.
English: Advanced cancer of the kidney (renal cancer).
Maltese: - Kanċer renali fi stat avvanzat (kanċer tal-kliewi).
English: For renal cancer, the recommended dose is 25 mg infused (as a drip) over a 30 to 60 minute period once weekly.
Maltese: Għal kanċer tal-kliewi, id-doża rakkomandata hi ta' 25 mg mogħtija bħala infużjoni (bħala dripp) fuq perijodu ta' 30 sa 60 minuta darba fil-ġimgħa.
English: Gingivitis
Maltese: Dilwizzjoni
English: Patients on temsirolimus who develop thrombocytopenia may be at increased risk of bleeding events, including epistaxis (see section 4.8).
Maltese: Pazjenti fuq temsirolimus li jiżviluppaw tromboċitopenija jistgħu jkunu f'riskju miżjud ta' avvenimenti ta' ħruġ ta' demm, li jinkludu li wieħed jinfaraġ (ara sezzjoni 4.8).
English: After first dilution of the concentrate with 1.8 ml of the supplied solvent, the mixture may be stored for up to 24 hours below 25°C and protected from light prior to further dilution.
Maltese: Wara l-ewwel dilwizzjoni tal-konċentrat b'1.8 ml tas-solvent fornut, it-taħlita tista' tinħażen f'temperatura taħt il-25C sa 24 siegħa, u għandha tkun protetta mid-dawl qabel dilwizzjoni addizzjonali.
English: Based on the results of the phase 3 studies, elderly patients may be more likely to experience certain adverse reactions, including face oedema, pneumonia, pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopenia, lymphopenia, myalgia, arthralgia, ageusia, dizziness, upper respiratory infection, mucositis, and rhinitis.
Maltese: Fuq il-bażi tar-riżultati mill-istudji ta' Fażi 3, il-pazjenti anzjani jistgħu jkunu aktar probabbli li jesperjenzaw ċerti reazzjonijiet avversi, inklużi edima fil-wiċċ, pnewmonja, effużjoni plewrali, ansjetà, dipressjoni, nuqqas ta' rqad, dispneja, lewkopenija, limfopenija, uġigħ fil-muskoli, artralġja, agewżja, sturdament, infezzjoni fil-parti ta' fuq tal-apparat respiratorju, mukożite, u rinite.
English: • Torisel, when diluted, contains polysorbate 80, and therefore appropriate administration materials must be used.
Maltese: • Meta dilwit, Torisel ikun fih polysorbate 80, u għalhekk għandu jintuża materjal talamministrazzjoni xieraq.
English: Name and address of the manufacturer responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott
English: Subjects with MCL (that was confirmed by histology, immunophenotype, and cyclin D1 analysis) who had received 2 to 7 prior therapies that included anthracyclines and alkylating agents, and rituximab (and could include haematopoietic stem cell transplant) and whose disease was relapsed and/or refractory were eligible for the study.
Maltese: Persuni b'MCL (li kienet ikkonfermata millistoloġija, immunofenotip, u analiżi ta' cyclin D1) li fil-passat irċivew minn 2 sa 7 terapiji li kienu jinkludu anthracyclines u sustanzi alkylating, u rituximab (li setgħu jinkludu trapjant ta' ċelluli staminali ematopojetiċi) u li l-marda tagħhom irkadiet u/jew kienet refrattarja, kienu eliġibbli għallistudju.
English: In order to address the uncertainties with regards to the efficacy and safety of Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names in the treatment of irritable bowel syndrome in adult patients, the MAH should conduct and submit the results of a well-designed and adequately powered multicentre double blind randomised placebo controlled post approval efficacy study allowing for relevant subpopulation analyses, in accordance with an agreed protocol to assess the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, both gender, disease severity and address the sustainability of efficacy The final study report should be submitted to the relevant National Competent Authorities.
Maltese: Sabiex jindirizza l-inċertezzi fir-rigward tal-effikaċja u s-sigurtà ta' Symbioflor 2 (batterja Escherichia coli (ċelluli u awtoliżat)) u lismijiet assoċjati fil-kura ta' sindrome tal-musrana irritabbli f'pazjenti adulti, l-MAH għandu jwettaq u jippreżenta r-riżultati ta' studju dwar l-effikaċja mfassal tajjeb u b'mod adegwat ibbażat fuq diversi ċentri, double-blind, randomizzat, ikkontrollat bil-plaċebo ta' wara l-approvazzjoni li jippermetti analiżijiet tas-sottopopolazzjoni rielvanti, skont protokoll li jkun sar qbil dwaru sabiex jivvaluta leffikaċja ta' Symbioflor 2 fil-kura tal-IBS inġenerali kontra sottotipi tal-marda bħal IBS C u IBS D, iż-żewġ sessi, is-severità tal-marda u jindirizza s-sostenibbiltà tal-effikaċja.
English: Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names
Maltese: Symbioflor 2 (batterja Escherichia coli (ċelluli u awtoliżat)) u lismijiet assoċjati
English: Conditions
Maltese: Kundizzjonijiet
English: Submission of the final study results by March
Maltese: Preżentazzjoni tar riżultati tal-istudju finali sa Marzu 2022.
English: Annex IV Conditions to the marketing authorisation(s)
Maltese: Anness IV
English: 15 January 2015 EMA/35715/2015
Maltese: EMA/35715/2015
English: Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1406430 (accessed 14/11/14).
Maltese: Disponibbli minn: http://www.nejm.org/doi/full/10.1056/NEJMoa1406430 (aċċessat 14/11/14).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom was observed in 5.3% of patients taking Corlentor/Procoralan compared with 3.8% in the placebo group.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom atrijali ġiet osservata f'5.3% tal-pazjenti li kienu qed jieħdu Corlentor/Procoralan meta mqabbel ma' 3.8% fil-grupp tal-plaċebo.
English: Corlentor/Procoralan is available as tablets.
Maltese: Corlentor/Procoralan huwa disponibbli bħala pilloli.
English: In the SIGNIFY study, atrial fibrillation
Maltese: Fl-istudju SIGNIFY fibrillazzjoni
English: Corlentor and Procoralan are identical medicines that contain the active substance ivabradine.
Maltese: Corlentor u Procoralan huma mediċini identiċi li fihom is-sustanza attiva l-ivabradina.
English: Contact our press officer Monika Benstetter
Maltese: Ikkuntattja l-uffiċjali tal-istampa tagħna Monika Benstetter
English: Corlentor/Procoralan received an EU-wide marketing authorisation on 25 October 2005.
Maltese: Corlentor/Procoralan irċieva awtorizzazzjoni għat-tqegħid fis-suq għall-UE kollha fil25 ta' Ottubru 2005.
English: The data also indicated a higher risk of bradycardia with Corlentor/Procoralan compared with placebo (17.9% vs.
Maltese: Id-data indikat ukoll riskju ogħla ta' bradikardija b'Corlentor/Procoralan meta mqabbel mal-plaċebo (17.9% vs.
English: Information to healthcare professionals
Maltese: Informazzjoni għall-pazjenti
English: 1 Fox K. Ford I, Steg PG, et al. Ivabradine in stable coronary artery disease without clinical heart failure.
Maltese: Ivabradine in stable coronary artery disease without clinical heart failure.
English: On 20 November 2014, the European Medicines Agency (EMA) completed a review of Corlentor/Procoralan (ivabradine) and made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine for angina.
Maltese: Fl-20 ta' Novembru 2014, l-Aġenzija Ewropea għall-Mediċini (EMA) lestiet reviżjoni ta' Corlentor/Procoralan (ivabradina) u għamlet rakkomandazzjonijiet indirizzati lejn it-tnaqqis tar-riskju ta' problemi tal-qalb, inklużi attakk tal-qalb u bradikardija (rata tal-qalb baxxa wisq), f'pazjenti li qed jieħdu l-mediċina għall-anġina.