FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Guide for healthcare professionals shall contain the following key elements: o Relevant information of the safety concerns addressed by the aRMM (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern addressed by the aRMM (i.e. contraindications, risk factors, increased risk by interactions with certain medicine) o Details on how to minimise the safety concern addressed by the aRMM through appropriate monitoring and management (i.e. what to do, what not do, and who is most likely be impacted according to different scenarios, like when to limit or stop prescribing/ingestion, how to administer the medicine, when to increase/decrease the dosage according to laboratory measurements, signs and symptoms) o Key message to convey in patients counselling o Instructions on how to handle possible adverse events o Information about the BSRBR, ARTIS, RABBIT and BIODABASER and UC registries and the importance of contributing to these
Maltese: • Il-Gwida għall-professjonisti tal-kura tas-saħħa għandu jkun fiha l-elementi ewlenin li ġejjin: o Informazzjoni rilevanti dwar it-tħassib dwar is-sikurezza indirizzat mill-aRRM (eż. isserjetà, is-severità, il-frekwenza, iż-żmien irrappurtat sal-bidu, ir-riversibbiltà tal-AE skont kif inhi applikabbli) o Dettalji tal-popolazzjoni li tinsab f'riskju ogħla għat-tħassib dwar is-sikurezza indirizzat mill-aRMM (jiġifieri, kontraindikazzjonijiet, fatturi ta' riskju, riskju miżjud minn interazzjonijiet ma' ċerta mediċina) o Dettalji dwar kif jiġi mminimizzat it-tħassib dwar is-sikurezza indirizzat mill-aRMM permezz ta' monitoraġġ xieraq u ġestjoni xierqa (jiġifieri, x'għandu jsir, x'm'għandux isir, u min għandu l-iktar probabbiltà li jintlaqat skont xenarji differenti, bħal meta l-għoti talmediċina b'riċetta/inġestjoni għandhom jiġu llimitati jew jitwaqqfu, kif għandha tingħata l-mediċina, meta għandu jiżdied/jitnaqqas id-dożaġġ skont miżuri tal-laboratorju, sinjali u sintomi) o Il-messaġġ ewlieni li għandu jitwassal fl-għoti ta' pariri lill-pazjenti o Struzzjonijiet dwar kif għandhom jiġu mmaniġġjati avvenimenti avversi possibbli o Informazzjoni dwar BSRBR, ARTIS, RABBIT u BIODABASER u r-reġistri f'UC u limportanza tal-kontribut lejn dawn
English: Study VI (O RAL Start)
Maltese: Studju VI (ORAL Step)
English: TNFi-IR Monotherapy, Active comparator (MT X),
Maltese: Komparatur attiv ta' (MTX), X
English: Table 17: Proportion of patients meeting efficacy endpoints at week 52 (OCTAVE sustain) Central endoscopy read
Maltese: Tabella 17: Proporzjon ta' pazjenti li ssodisfaw il-punti tat-tmiem tal-effikaċja f'ġimgħa 52 (OCTAVE Sostenn)
English: Blood creatine phosphokinase increased
Maltese: Żieda fil-livell tal-kreatina talphosphokinase
English: Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).
Maltese: It-titjib tad-dehra endoskopika tal-mukuża ġie definit bħala sottopunteġġ tal-endoskopija Mayo ta' 0 (marda normali jew mhux attiva) jew 1 (eritema, xejra vaskulari mnaqqsa).
English: In an RA controlled clinical trial, elevations in LDL cholesterol and ApoB decreased to pretreatment levels in response to statin therapy.
Maltese: Fi prova klinika kkontrollata dwar RA, l-elevazzjonijiet fil-kolesterol tal-LDL u ApoB naqsu għallivelli ta' qabel il-kura f'rispons għat-terapija bi statin.
English: For oral use.
Maltese: NA ORAL Standard:
English: Possible serious side effects In rare cases, infection may be life-threatening
Maltese: Effetti sekondarji serji possibbli F'każijiet rari, l-infezzjoni tista' tkun ta' theddida għall-ħajja
English: CLINICAL PARTICULARS
Maltese: Rispons kliniku
English: In both subgroups of patients with or without prior TNF inhibitor failure, a greater proportion of patients treated with either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily achieved the following endpoints at week 52 of OCTAVE Sustain as compared to placebo: remission, improvement of endoscopic appearance of the mucosa, or sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline (Table 18).
Maltese: Fiż-żewġ sottogruppi ta' pazjenti bi jew mingħajr falliment fil-passat ta' inibitur ta' TNF, proporzjon ikbar ta' pazjenti kkurati b'jew tofacitinib 5 mg darbtejn kuljum jew tofacitinib 10 mg darbtejn kuljum kisbu l-punti tat-tmiem li ġejjin f'ġimgħa 52 ta' OCTAVE Sostenn meta mqabbel mal-plaċebp: remissjoni, titjib tad-dehra endoskopika tal-mukuża, jew remissjoni mingħajr kortikosterojdi sostnuta kemm f'ġimgħa 24 kif ukoll f'ġimgħa 52 fost pazjenti f'remissjoni fil-linja bażi (Tabella 18).
English: Clinical response was defined as a decrease from baseline in Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or absolute subscore for rectal bleeding of 0 or
Maltese: Ir-rispons kliniku ġie definit bħala tnaqqis mil-linja bażi fil-punteġġ Mayo ta' ≥ 3 punti u ≥ 30%, bi tnaqqis ta' akkumpanjament fis-sottopunteġġ għal fsada mir-rektum ta' ≥punt 1 jew sottopunteġġ assolut għal fsada mir-rektum ta' 0 jew 1.
English: - XELJANZ 11 mg prolonged-release tablet is pink and oval in appearance.
Maltese: - XELJANZ 11 mg pillola li terħi l-mediċina bil-mod għandha dehra roża u ovali.
English: Cough
Maltese: MG
English: Remission among patients in remission at baselinea,f
Maltese: Manteniment tarrispons kliniku Remissjoni fost pazjenti f'remissjoni fillinja bażi a,f
English: Steady-state AUC and Cmax of tofacitinib for tofacitinib 11 mg prolonged-release tablet administered once daily are equivalent to those of tofacitinib 5 mg film-coated tablets administered twice daily.
Maltese: L-AUC u sCmax fi stat fiss ta' tofacitinib għal tofacitinib 11 mg pillola li terħi l-mediċina bil-mod mogħtija darba kuljum huma ekwivalenti għal dawk ta' tofacitinib 5 mg pilloli miksijin b'rita mogħtija darbtejn kuljum.
English: In ORAL Standard and ORAL Scan, mean FACIT-F improvements were maintained to 12 months in tofacitinib-treated patients.
Maltese: F'ORAL Standard u ORAL Scan, it-titjib medju fiż-żewġ skali inżamm sa 12-il xahar f'pazjenti kkurati b'tofacitinib.
English: Tofacitinib 10 mg twice daily + MTX Mean difference from placebob
Maltese: Tofacitinib 10 mg darbtejn kuljum + MTX Medja ta' differenza millplaċebo (CI)
English: Durability of effect was assessed by ACR20, ACR50, ACR70 response rates in studies of duration of up to two years.
Maltese: Id-durabilità tal-effett kienet ivvalutata permezz tar-rati ta' rispons tal-ACR20, ACR50, ACR70 fi studji ta' tul ta' żmien sa sentejn.
English: Tofacitinib 5 mg twice daily Mean difference from MTXd (CI)
Maltese: Tofacitinib 5 mg darbtejn kuljum Differenza medja minn MTX
English: Table 2: Low absolute neutrophil count Low absolute neutrophil count (ANC) (see section 4.4)
Maltese: Tabella 2: Għadd assolut tan-newtrofili baxx Għadd assolut tan-newtrofili baxx (ANC) (ara sezzjoni 4.4) Valur tal-Laboratorju (ċelluli/mm
English: Tofacitinib dose should be reduced to 5 mg once daily in patients receiving 5 mg twice daily (see section 4.2).
Maltese: Id-doża ta' tofacitinib għandha titnaqqas għal 5 mg darba kuljum f'pazjenti li jirċievu 5 mg darbtejn kuljum (ara sezzjoni 5.2).
English: Each prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
Maltese: Kull pillola fiha 11 mg ta' tofacitinib (bħala tofacitinib citrate).
English: NA ORAL Start: MTX-naïve
Maltese: Tabella 3:Valur tal-emoglobina baxx
English: Month 6 (placebo subjects with < 20% improvement in swollen and tender joint counts advanced to tofacitinib at month 3)
Maltese: Xahar 3 Xahar 6 (individwi li jieħdu lplaċebo b'titjib ta' <20% flgħadd ta' ġogi minfuħin u teneri avvanzaw għal tofacitinib f'xahar 3)
English: Inadequate response to at least 1 csDMARD due to lack of efficacy and/or intolerability.
Maltese: Rispons inadegwat għal mill-inqas csDMARD 1 minħabba nuqqas ta' effikaċja u/jew intollerabilità.
English: XELJANZ 5 mg film-coated tablets XELJANZ 5 mg film-coated tablet is white and round in appearance.
Maltese: XELJANZ 5 mg pilloli miksija b'rita XELJANZ 5 mg pillola miksija b'rita għandha dehra bajda u tonda.
English: ≤3 weekly doses (MTX-naïve).
Maltese: ≤3 dożi ta' kull ġimgħa (mingħajr esperjenza ta' MTX).
English: Physical function and health-related quality of life Improvement in physical functioning was measured by the HAQ-DI.
Maltese: Funzjoni fiżika u kwalità tal-ħajja relatata mas-saħħa It-titjib fil-funzjoni fiżika tkejjel mill-HAQ-DI.
English: In the induction and maintenance studies, across tofacitinib and placebo treatment groups, the most common categories of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC.
Maltese: Fl-istudji ta' induzzjoni u manteniment, fost il-gruppi ta' kura b'tofacitinib u bil-plaċebo, l-aktar kategoriji komuni ta' reazzjonijiet avversi serji kienu disturbi u infezzjonijiet gastro-intestinali, u rreazzjoni avversa serja l-aktar komuni kienet aggravar ta' UC.
English: ORAL Start: MTX-naïve
Maltese: MTX f'ORAL Start).
English: Study duration
Maltese: Sena Sena
English: For recommended modifications based on lymphocyte counts, see section 4.2.
Maltese: Għal modifikazzjonijiet rakkomandati abbażi tal-għadd tallimfoċiti, ara sezzjoni 4.2.
English: In this study, AST elevations greater than 3x ULN were observed in 1.65%, 0.41% and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: F'dan l-istudju, l-elevazzjonijiet fl-AST akbar minn 3x ULN kienu osservati f'1.65%, 0.41%, u 0% tal-pazjenti li jirċievu l-plaċebo, tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: Erythema Pruritus
Maltese: Il-Ġermanja
English: Package leaflet: Information for the patient XELJANZ 11 mg prolonged-release tablets tofacitinib
Maltese: Informazzjoni għall-pazjent XELJANZ 11 mg pilloli li jerħu l-mediċina bil-mod tofacitinib
English: Changes in total serum IgG, IgM, and IgA levels over 6-month tofacitinib dosing in patients with RA were small, not dose-dependent and similar to those seen on placebo, indicating a lack of systemic humoral suppression.
Maltese: Il-bidliet fil-livelli ta' IgG, IgM, u IgA fis-serum fuq doża ta' tofacitinib ta' 6 xhur f'pazjenti b'RA kienu żgħar, mhux dipendenti fuq id-doża u simili għal dawk li dehru fil-plaċebo, li jindikaw nuqqas ta' suppressjoni umorali sistemika.
English: Patients were to be in clinical response at baseline of the maintenance study OCTAVE Sustain.
Maltese: Il-pazjenti kellhom ikunu f'rispons kliniku fil-linja bażi tal-Istudju ta' manteniment OCTAVE Sostenn e.
English: For patients with Baseline score > 0.
Maltese: Għal pazjenti b'punteġġ fil-Linja bażi > 0.
English: There was no evidence of a relationship between serious or opportunistic infections or herpes zoster and lymphocyte subset counts (see section 4.2 for absolute lymphocyte count monitoring).
Maltese: M'hemmx evidenza ta' relazzjoni bejn infezzjonijiet serji jew opportunistiċi jew herpes zoster u għadd tas-sottosett tal-limfoċiti (ara sezzjoni 4.2 għall-monitoraġġ assolut tal-għadd tal-limfoċiti).
English: Patients treated with tofacitinib 5 mg film-coated tablets twice daily may be switched to tofacitinib 11 mg prolonged-release tablets once daily on the day following the last dose of tofacitinib 5 mg film-coated tablets.
Maltese: Id-doża għandha titnaqqas għal 5 mg pilloli miksija b'rita darba kuljum meta d-doża indikata fil-preżenza ta' funzjoni tal-fwied normali tkun 11 mg pillola li terħi l-mediċina bil-mod darba kuljum (ara sezzjoni 5.2).
English: Dose adjustment in renal impairment for different strength tablets
Maltese: Aġġustament tad-doża f'indeboliment tal-kliewi għal pilloli ta' qawwa differenti
English: Caution should be used when administering tofacitinib 11 mg prolonged-release tablets to patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).
Maltese: Għandha tintuża l-kawtela meta tofacitinib 11 mg pilloli li jerħu l-mediċina bil-mod jingħataw lil pazjenti b'tidjiq gastrointestinali sever preeżistenti (patoloġiku jew iatroġeniku).
English: Tofacitinib should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis, patients with concomitant use of corticosteroids and/or nonsteroidal anti-inflammatory drugs).
Maltese: Tofacitinib għandu jintuża b'kawtela f'pazjenti li jistgħu jkunu f'riskju ogħla ta' perforazzjoni gastrointestinali (eż., pazjenti bi storja ta' divertikulite, pazjenti b'użu konkomitanti ta' kortikosterojdi u/jew mediċini anti-infjammatorji mhux sterojdi).
English: • The recommended dose is 10 mg twice a day for 8 weeks, followed by 5 mg twice a day.
Maltese: • Id-doża rakkomandata hija ta' 10 mg darbtejn kuljum għal 8 ġimgħat, segwita minn 5 mg darbtejn kuljum.
English: Baseline corticosteroid use
Maltese: Herpes simplex Gastroenterite virali
English: • hives (itching or skin rash)
Maltese: • ħorriqija (ħakk jew raxx tal-ġilda)
English: As with the overall ACR response in patients treated with 5 mg or 10 mg twice daily tofacitinib, each of the components of the ACR response was consistently improved from baseline including: tender and swollen joint counts; patient and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
Maltese: Bħar-rispons tal-ACR ġenerali f'pazjenti kkurati b'tofacitinib ta' 5 mg jew ta' 10 mg darbtejn kuljum, kull wieħed mill-komponenti tar-rispons tal-ACR tjieb b'mod konsistenti mil-linja bażi inkluż: għadd ta' ġogi teneri u minfuħin; valutazzjoni ġenerali tal-pazjent u tat-tabib; punteġġi talindiċi tad-diżabilità; valutazzjoni tal-uġigħ u tas-CRP mqabbla ma' pazjenti li jirċievu l-plaċebo kif ukoll MTX jew DMARDs oħrajn fl-istudji kollha.
English: Tofacitinib 10 mg twice daily Mean difference from MTXd (CI)
Maltese: Tofacitinib 10 mg darbtejn kuljum Differenza medja minn MTX
English: The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
Maltese: Il-varjabilità bejn lindividwi (koeffiċjent tal-perċentwali tal-varjazzjoni) fl-AUC ta' tofacitinib hija stmata li hija bejn wieħed u ieħor 27%.
English: Dose should be reduced to 5 mg film-coated tablet once daily when the indicated dose in the presence of normal renal function is 11 mg prolonged-release tablet once daily (see section 5.2).
Maltese: Id-doża għandha titnaqqas għal 5 mg darbtejn kuljum meta d-doża indikata fil-preżenza ta' funzjoni tal-kliewi normali tkun 10 mg darbtejn kuljum (ara sezzjoni 5.2).
English: After intravenous administration, the volume of distribution is 87 L. Approximately 40% of circulating tofacitinib is bound to plasma proteins.
Maltese: Bejn wieħed u ieħor 40% ta' tofacitinib li jiċċirkola huwa marbut mal-proteini tal-plażma.
English: Physical function response and health-related outcomes
Maltese: Rispons tal-funzjoni fiżika u riżultati relatati mas-saħħa
English: Patients treated with tofacitinib 11 mg prolonged-release tablets once daily may be switched to tofacitinib 5 mg film-coated tablets twice daily on the day following the last dose of tofacitinib 11 mg prolonged-release tablets.
Maltese: Id-doża għandha titnaqqas għal 5 mg pillola miksija b'rita darba kuljum meta d-doża indikata fil-preżenza ta' funzjoni talkliewi normali tkun 11 mg pillola li terħi l-mediċina bil-mod darba kuljum (ara sezzjoni 5.2).
English: In ORAL Scan, mean SF-36 improvements were maintained to 12 months in tofacitinib-treated patients.
Maltese: F'ORAL Scan, it-titjib medju ta' SF-36 inżamm sa 12il xahar f'pazjenti kkurati b'tofacitinib.
English: Malignancy and lymphoproliferative disorder
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: In the RA long-term extension studies, on background DMARDs, ALT elevations greater than 3x ULN were observed in 1.8% and 1.6% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively.
Maltese: Fl-istudji ta' estensjoni fit-tul dwar monoterapija dwar RA dwar DMARDs fl-isfond, żidiet fl-AST ta' aktar minn 3 darbiet tal-ULN ġew osservati f'1.8% u 1.6% tal-pazjenti li kienu qed jirċievu tofacitinib 5 mg u 10 mg darbtejn kuljum, rispettivament.
English: Patients treated with tofacitinib who are Japanese or Korean, or patients with long standing RA who have previously received two or more biological DMARDs, or patients with an ALC less than 1,000 cells/mm3, or patients treated with 10 mg twice daily may have an increased risk of herpes zoster (see section 4.4).
Maltese: Il-pazjenti kkurati b'tofacitinib li huma Ġappuniżi jew Koreani, jew pazjenti li kellhom RA għal żmien twil u li fil-passat kienu rċivew żewġ DMARDs bijoloġiċi, jew pazjenti b'ALC anqas minn 1,000 ċellula/mm3, jew pazjenti kkurati b'10 mg darbtejn kuljum jista' jkollhom riskju miżjud ta' herpes zoster (ara sezzjoni 4.4).
English: At baseline,
Maltese: U L-UŻU
English: Tofacitinib exposure is increased when coadministered with potent inhibitors of CYP3A4 (e.g., ketoconazole) or when administration of one or more concomitant medicinal products results in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole) (see section 4.2).
Maltese: (eż., ketoconazole) jew meta l-għoti ta' prodott mediċinali konkomitanti wieħed jew aktar jirriżultaw kemm f'inibizzjoni moderata ta' CYP3A4 kif ukoll f'inibizzjoni qawwija ta' CYP2C19 (eż., fluconazole) (ara sezzjoni 4.2).
English: Lymphocytes
Maltese: FARMAĊEWTIKU
English: Active substance: Ceftiofur
Maltese: Ceftiofur
English: Target species Route of administration
Maltese: Speċi Metodu ta' Amministrazzjoni
English: Milk: zero days.
Maltese: Laħam u interjuri: 9 ijiem.
English: Subcutaneous use
Maltese: Sustanza Attiva:
English: Date of first authorisation: 22nd May 2017
Maltese: Mejju 22, 2017
English: Sick sinus syndrome
Maltese: - Sindromu sick sinus
English: Bradycardia AV 1st degree block (ECG prolonged PQ
Maltese: Imblokk AV 1 grad (ECG prolongat flinterval PQ)
English: (see section 5.1)
Maltese: (ara sezzjoni 4.6)
English: Placebo (N=3264) n (%)
Maltese: Plaċebo (N=3264)
English: The median follow-up duration was 22.9 months.
Maltese: Ilperijodu ta' segwitu medjan kien 22.9 xhur.
English: Patients received standard care including beta-blockers (89 %), ACE inhibitors and/or angiotensin II antagonists (91 %), diuretics (83 %), and anti-aldosterone agents (60 %).
Maltese: Il-pazjenti rċevew kura standard li kienet tinkludi imblokkaturi tar-riċetturi beta (89 %), inibituri ACE u/jew antagonisti ta' angiotensin II (91 %), dijuretiċi (83 %), u sustanzi kontra l-aldosterone (60 %).
English: The mean ivabradine doses allowing to achieve a 20% HRR were 0.13 ± 0.04 mg/kg bid, 0.10 ± 0.04 mg/kg bid and 4.1 ± 2.2 mg bid in the age subsets [1-3] years, [3-18] years and <40 kg and [3-18] years and ≥ 40 kg, respectively.
Maltese: Id-dożi medji ta' ivabradine li jippermettu li jintlaħaq HRR ta' 20% kienu 0.13 ± 0.04 mg/kg darbtejn kuljum, 0.10 ± 0.04 mg/kg darbtejn kuljum u 4.1 ± 2.2 mg darbtejn kuljum fis-subsettijiet ta' età ta' [1-3] snin, [3-18]-il sena u <40 kg u [3-18]-il sena u ≥ 40 kg, rispettivament.
English: Ivabradine influences on retinal function.
Maltese: Ivabradine jinfluwenza fuq il-funzjoni retinali.
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000
Maltese: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 Glycerol (E 422) Talc (E553b) Iron oxide isfar (E172)
English: Reporting of side effects
Maltese: Rappourtar ta' effetti sekondarji
English: QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol,
Maltese: Mediċini li jtawwlu l-QT - Mediċini kardjovaskulari li jtawwlu l-QT (eż. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone).
English: Ivabradine Accord 7.5 mg film-coated tablets EU/1/17/1190/008
Maltese: Ivabradine Accord 7.5 mg pilloli miksija b'rita EU/1/17/1190/008
English: Ivabradine Accord 7.5 mg
Maltese: Ivabradine Accord 5 mg Ivabradine Accord 7.5 mg
English: Ivabradine Accord 5 mg film-coated tablets EU/1/17/1190/001
Maltese: Ivabradine Accord 5 mg pilloli miksija b'rita EU/1/17/1190/001
English: 14x1 film-coated tablets 28x1 film-coated tablets 56x1 film-coated tablets 84x1 film-coated tablets 98x1 film-coated tablets 100x1 film-coated tablets 112x1 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28x1 pillola miksija b'rita 56x1 pillola miksija b'rita 84x1 pillola miksija b'rita 98x1 pillola miksija b'rita 100x1 pillola miksija b'rita 112x1 pillola miksija b'rita
English: AV 2nd degree block, AV 3rd degree block
Maltese: Imblokk AV tat-2ni grad, imblokk AV
English: Ivabradine Accord film-coated tablets are available in Aluminium/ Aluminium perforated unit dose blister in pack sizes of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 or 112x1 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-pilloli miksija b'rita Ivabradine Accord huma disponibbli f'folji perforati talAluminium/Aluminium b'doża waħda f'daqsijiet tal-pakkett ta' 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 jew 112-il pillola.
English: In pivotal phase III clinical trials the following medicinal products were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, beta-blockers, diuretics, anti-aldosterone agents, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other antiplatelet medicinal products.
Maltese: III tal-provi kliniċi, il-prodotti mediċinali msemmija hawn taħt ingħataw bħas-soltu flimkien ma' ivabradine mingħajr l-ebda evidenza ta' biża fuq is-sigurtà: impedituri angiotensin converting enżemi, antagonisti angiotensin II, imblokkaturi tar-riċetturi beta, dijuretiċi, sustanzi kontra l-aldosterone agents, nitrates li jaħdmu fil-qosor u fit-tul, impedituri HMG CoA reductase, fibrates, impedituri proton pump, antidijabetiċi orali, aspirin u prodotti mediċinali oħra antiplatelet.
English: Other medicines and Ivabradine Accord
Maltese: Mediċini oħra u Ivabradine Accord
English: A small statistically significant increase in the PCE was observed in a pre-specified subgroup of patients with angina patients in CCS class II or higher at baseline (n=12049) (annual rates 3.4% versus 2.9%, relative risk ivabradine/placebo 1.18, p=0.018), but not in the subgroup of the overall angina population in CCS class ≥ I (n=14286) (relative risk ivabradine/placebo 1.11, p=0.110).
Maltese: Ġiet osservata żieda statistikament sinifikanti żgħira fil-PCE f'sottogrupp ta' pazjenti speċifikat minn qabel b'anġina fil-klassi CCS II jew ogħla fil-linja bażi (n=12,049) (rati annwali 3.4% meta mqabbel ma' 2.9%, riskju relattiv ta' ivabradine/plaċebo 1.18, p=0.018), iżda mhux fissottogrupp tal- popolazzjoni globali tal-anġina fil-klassi CCS ≥ I (n=14,286) (riskju relattiv ta' ivabradine/plaċebo 1.11, p=0.110).
English: In a 1277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0-1.7]; p=0.012).
Maltese: Fi studju randomizzat kkontrollat bi plaċebo li involva 1277 pazjent, ivabradine wera effikaċja addizzjonali statistikament sinifikanti fuq ir-rispons għall-kura (definit bħala tnaqqis ta' millinqas 3 attakki ta' anġina fil-ġimgħa u/jew żieda fil-ħin sa dipressjoni tas-segment ST ta' 1 mm ta' millinqas 60 sekonda matul ETT fuq treadmill) flimkien ma' amlodipine 5 mg o.d. jew nifedipine GITS 30 mg o.d fl-inqas punt tal-attività tal-mediċina (12-il siegħa wara it-teħid ta' ivabradine mill-ħalq) fuq perijodu ta' kura ta'6 ġimgħat (OR = 1.3, 95 % CI [1.0-1.7]; p = 0.012).