FrancophonIA/ELRC3.0 huggingface dataset:
English: The Hazard Ratio (Edoxaban 60 mg vs. warfarin) for the primary endpoint in the centres with a lower average time of INR in the target range (INR TTR) for warfarin was 0.73 - 0.80 for the lowest 3 quartiles (INR TTR ≤ 57.7% to ≤ 73.9%).
Maltese: kwartili l-iktar baxxi (INR TTR ≤ 57.7% sa ≤ 73.9%).
English: Like other similar medicines (medicines to reduce blood clotting), Lixiana may cause bleeding which may potentially be life-threatening.
Maltese: Bħal mediċini simili oħrajn (mediċini biex inaqqsu t-tagħqid tad-demm), Lixiana jista' jikkawża emorraġija li jista' potenzjalment jkun ta' periklu għall-ħajja.
English: 100 film-coated tablets 10 x 1 film-coated tablets 50 x 1 film-coated tablets 100 x 1 film-coated tablets
Maltese: Jiġu f'folji f'kaxxi tal-kartun ta' 10 pilloli miksija b'rita jew folji tad-doża tal-unità f'kaxxi tal-kartun ta' 10 x 1 pillola miksija b'rita.
English: In a pre-specified subgroup analysis of PE subjects 447 (30.6%) and 483 (32.2%) of edoxaban and warfarin treated subjects, respectively, were identified as having PE and NT-proBNP ≥ 500 pg/mL.
Maltese: 6%) u 483 (32.2%) individwu kkurati b'edoxaban u warfarin, rispettivament, ġew identifikati bħala li kellhom PE u NT-proBNP ≥ 500 pg/mL.
English: The results for all-cause mortality (adjudicated deaths) in the ENGAGE AF-TIMI 48 study were 769 (3.99% per year) for subjects taking edoxaban 60 mg (30 mg dose reduced) as opposed to 836 (4.35% per year) for warfarin [HR (95% CI): 0.91 (0.83, 1.01)].
Maltese: Ir-riżultati għall-mortalità mill-kawżi kollha (imwiet aġġudikati) fl-istudju ENGAGE AF-TIMI 48 kienu 769 (3.99% kull sena) għal individwi li kienu qed jieħdu edoxaban 60 mg (doża mnaqqsa ta' 30 mg) meta mqabbla ma' 836 (4.35% kull sena) għal warfarin [HR (95% CI): 0.91 (0.83, 1.01).
English: Therefore Lixiana is contraindicated during breast-feeding (see section 4.3).
Maltese: Għalhekk, Lixiana huwa kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study (for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors), the event rate was: 2.29% per year for the primary endpoint, compared to the event rate of 2.66% per year for the matching subjects in the warfarin group [HR (95% CI): 0.86 (0.66, 1.13)].
Maltese: F'analiżijiet tas-sottogruppi, għal individwi fil-grupp ta' kura ta' 60 mg li tnaqqsitilhom id-doża għal 30 mg fl-istudju ENGAGE AF-TIMI 48 (minħabba piż tal-ġisem ta' ≤ 60 kg, indeboliment moderat tal-kliewi, jew l-użu fl-istess ħin ta' inibituri ta' P-gp), ir-rata t'avvenimenti kienet: 2.29% kull sena għall-punt aħħari primarja, meta mqabbla mar-rata ta' avvenimenti ta' 2.66% kull sena għall-individwi mqabbla fil-grupp ta' warfarin [HR (95% CI): 0.86 (0.66, 1.13)].
English: Lixiana 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Maltese: Lixiana 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (pilloli ta' 15 u 30 mg biss) (E172), iron oxide yellow (pillola ta' 15 u 60 mg biss) (E172).
English: EU/1/15/993/002 10 film-coated tablets
Maltese: EU/1/15/993/002, EU/1/15/993/004-015
English: Co-administration of edoxaban with the P-gp inducer rifampicin led to a decrease in mean edoxaban AUC and a shortened half-life, with possible decreases in its pharmacodynamic effects.
Maltese: L-għoti ta' edoxaban flimkien mal-induttur ta' P-gp rifampicin wassal għal tnaqqis fl-AUC medja ta' edoxaban u half-life imqassra, bi tnaqqis possibbli fl-effetti farmakodinamiċi tiegħu.
English: In subgroup analyses, for subjects who were dose reduced to 30 mg in the Hokusai-VTE study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 58 (7.9%) of edoxaban 30 mg dose reduced subjects and 92 (12.8%) of warfarin subjects had a major bleeding or CRNM event [HR (95%): 0.62 (0.44, 0.86)].
Maltese: F'analiżijiet tas-sottogruppi, għal individwi li tnaqqsitilhom id-doża għal 30 mg fl-istudju HokusaiVTE minħabba piż tal-ġisem ta' ≤ 60 kg, indeboliment moderat tal-kliewi, jew l-użu fl-istess ħin ta' inibituri ta' P-gp, 58 (7.9%) ta' individwi li ngħataw doża imnaqqsa ta' edoxaban 30 mg u 92 (12.8%) ta' individwi li ngħataw doża mnaqqsa ta' warfarin, kellhom avveniment ta' emorraġija maġġuri jew CRNM [HR (95%): 0.62 (0.44, 0.86)].
English: Changing from Lixiana to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban)
Maltese: Meta tibdel minn Lixiana għal antikoagulanti orali mhux VKA (dabigatran, rivaroxaban, jew apixaban)
English: Taking an anticoagulant medicine such as Lixiana can increase your risk of bleeding.
Maltese: Meta tieħu mediċina antikoagulanti bħal Lixiana, dan jista' jżid ir-riskju tiegħek għal emorraġija.
English: If you currently take 60 mg Lixiana:
Maltese: Lixiana 30 mg:
English: In case of clinically significant bleeding, stop treatment immediately.
Maltese: F'każ ta' emorraġija klinikament sinifikanti, waqqaf il kura immedjatament.
English: There was a significant risk reduction in favour of edoxaban compared with warfarin for the primary safety endpoint of clinically relevant bleeding, a composite of major bleeding or clinically relevant non-major bleeding (CRNM), which occurred in 349 of 4,118 subjects (8.5%) in the edoxaban group and in 423 of 4,122 subjects (10.3%) in the warfarin group [HR (95% CI): 0.81 (0.71, 0.94); p = 0.004 for superiority].
Maltese: Kien hemm tnaqqis sinifikanti fir-riskju favur edoxaban meta mqabbel ma' warfarin għall-punt aħħari tas-sigurtà primarja ta' emorraġija klinikament rilevanti, kompost ta' emorraġija maġġuri jew emorraġija klinikament rilevanti mhux maġġuri (CRNM), li seħħew fi 349 minn 4,118-il individwu (8.5%) fil-grupp ta' edoxaban u f'423 minn 4,122 individwu (10.
English: Detailed information on this product is available by scanning the QR Code below with a smartphone.
Maltese: Informazzjoni dettaljata fuq dan prodott hi disponibbli billi tiskennja l-Kodiċi QR hawn taħt bi smartphone.
English: How to store Lixiana
Maltese: Kif taqleb minn Lixiana
English: NAME OF THE MEDICINAL PRODUCT Lixiana 60 mg film-coated tablets edoxaban
Maltese: Lixiana 60 mg, pilloli miksija b'rita edoxaban
English: EU/1/15/993/025 100 film-coated tablets EU/1/15/993/026 10 x 1 film-coated tablets EU/1/15/993/027 50 x 1 film-coated tablets EU/1/15/993/028 100 x1 film-coated tablets
Maltese: EU/1/15/993/003 10 pilloli miksija b'rita EU/1/15/993/017 14-il pillola miksija b'rita EU/1/15/993/018 28 pillola miksija b'rita EU/1/15/993/019 30 pillola miksija b'rita EU/1/15/993/020 56 pillola miksija b'rita EU/1/15/993/021 60 pillola miksija b'rita EU/1/15/993/022 84 pillola miksija b'rita EU/1/15/993/023 90 pillola miksija b'rita EU/1/15/993/024 98 pillola miksija b'rita EU/1/15/993/025 100 pillola miksija b'rita EU/1/15/993/026 10 x 1 pillola miksija b'rita EU/1/15/993/027 50 x 1 pillola miksija b'rita EU/1/15/993/028 100 x 1 pillola miksija b'rita
English: Ciclosporin, dronedarone, erythromycin, ketoconazole
Maltese: Piż Baxx tal-Ġisem ≤ 60 kg Inibituri ta' P-gp Ciclosporin, dronedarone, erythromycin, ketoconazole
English: Subjects in both edoxaban treatment groups had their dose halved if one or more of the following clinical factors were present: moderate renal impairment (CrCL 30 - 50 mL/min), low body weight (≤ 60 kg) or concomitant use of specific P-gp inhibitors (verapamil, quinidine, dronedarone).
Maltese: L-individwi fiż-żewġ gruppi ta' kura b'edoxaban kellhom doża mnaqqsa bin-nofs jekk xi wieħed jew aktar mill-fatturi kliniċi li ġejjin kienu preżenti: indeboliment moderat tal-kliewi (CrCL 30 - 50 mL/min), piż baxx tal-ġisem (60 kg) jew l-użu fl-istess ħin ta' inibituri speċifiċi ta' P-gp (verapamil, quinidine, dronedarone).
English: For subjects presenting with PE (with or without DVT), 47 (2.8%) of edoxaban and 65 (3.9%) of warfarin subjects had a recurrent VTE [HR (95% CI): 0.73 (0.50,
Maltese: Għal individwi li kellhom PE (bi jew mingħajr DVT), 47 (2.8%) ta' edoxaban u 65 (3.9%) tal-individwi li kienu fuq warfarin kellhom VTE rikorrenti [HR (95% CI): 0.73 (0.50, 1.06)].
English: NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets edoxaban
Maltese: Informazzjoni għall-utent Lixiana 15 mg, pilloli miksija b'rita
English: What Lixiana looks like and contents of the pack Lixiana 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.
Maltese: Lixiana 15 mg pilloli miksija b'rita huma ta' lewn oranġjo, tondi (dijametru ta' 6.7 mm) u mnaqqxa b'“DSC L15” fuq naħa waħda.
English: The safety and efficacy of Lixiana in children and adolescents less than 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Lixiana fit-tfal u adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: LDA Tel: +351 21 4232010
Maltese: Tel: +421 (2) 58282010
English: Discontinue dabigatran, rivaroxaban or apixaban and start Lixiana at the time of the next dose of the oral anticoagulant (see section 5.1).
Maltese: Waqqaf dabigatran, rivaroxaban or apixaban u ibda Lixiana fil-ħin tad-doża mhux talantikoagulant orali li jkun imiss (ara sezzjoni 5.1).
English: The primary safety endpoint was major bleeding.
Maltese: Il-punt aħħari tas-sigurtà primarja kien emorraġija maġġuri.
English: • Itching
Maltese: • Sturdament
English: Breast-feeding
Maltese: TAL-PAZJENT
English: In patients concomitantly taking Lixiana and the following P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is 30 mg Lixiana once daily (see section 4.5).
Maltese: L-użu fl-istess ħin ta' Lixiana ma' inibituri ta' P-glikoproteina (P-gp) F'pazjenti li jkunu qed jieħdu Lixiana u l-inibituri ta' P-gp li ġejjin fl-istess ħin: ciclosporin, dronedarone, erythromycin, jew ketoconazole, id-doża rakkomandata hija ta' 30 mg ta' Lixiana darba kuljum (ara sezzjoni 4.5).
English: (%/year)
Maltese: NUMRU(I)
English: In patients with end stage renal disease (ESRD) (CrCL < 15 mL/min) or on dialysis, the use of Lixiana is not recommended (see sections 4.4 and 5.2).
Maltese: F'pazjenti b'mard tal-kliewi li jkun fl-aħħar stadju (end stage renal disease, ESRD) (CrCL < 15 mL/min) jew fuq id-dijalisi, l-użu ta' Lixiana mhuwiex rakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: Lixiana 60 mg film-coated tablets
Maltese: Lixiana 60 mg, pilloli miksija b'rita
English: Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding, as judged to be appropriate.
Maltese: Għalhekk, minbarra sorveljanza klinika adegwata, ittestjar tal-laboratorju tal-emoglobina/ematokrita jista' jkun ta' valur biex jinkixef fsad li ma jidhirx, kif meqjus xieraq.
English: Lixiana 30 mg film-coated tablets
Maltese: Lixiana 30 mg, pilloli miksija b'rita
English: Lower GI haemorrhage
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: NAME OF THE MEDICINAL PRODUCT Lixiana 30 mg film-coated tablets edoxaban
Maltese: Lixiana 30 mg, pilloli miksija b'rita edoxaban
English: Edoxaban inhibits free factor Xa, and prothrombinase activity.
Maltese: Edoxaban jinibixxi fattur Xa ħieles, u l-attività ta' prothrombinase.
English: For patients with body weight ≤ 60 kg, the recommended dose is 30 mg Lixiana once daily (see section 5.2).
Maltese: F'pazjenti b'piż tal-ġisem ta' ≤ 60 kg, id-doża rakkomandata hija ta' 30 mg ta' Lixiana darba kuljum (ara sezzjoni 5.2).
English: EU/1/15/993/017 14 film-coated tablets
Maltese: EU/1/15/993/003, EU/1/15/993/017-028
English: The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see section 4.9 Management of bleeding).
Maltese: Is-sinjali, sintomi, u s-severità (inkluż riżultat fatali) se jvarjaw skont il-post u l-grad, jew skont il-vastità tal-fsada u/jew anemija (ara sezzjoni 4.9 Immaniġġar ta' Fsada).
English: EU/1/15/993/019 30 film-coated tablets
Maltese: EU/1/15/993/00, EU/1/15/993/016
English: In the clinical studies mucosal bleedings (e.g. epistaxis, gastrointestinal, genitourinary) and anaemia were seen more frequently during long term edoxaban treatment compared with VKA treatment.
Maltese: Fl-istudji kliniċi fsada mill-mukuża (jiġifieri epistassi, gastro-intestinali, sistema ġenitali u tal-awrina) u anemija kienu osservati aktar ta' spiss waqt kura fit-tul b'edoxaban meta mqabbla ma' kura b'VKA.
English: Concomitant use of edoxaban with ciclosporin, dronedarone, erythromycin, or ketoconazole requires dose reduction to 30 mg once daily.
Maltese: L-użu flistess ħin ta' edoxaban ma' ciclosporin, dronedarone, erythromycin, jew ketoconazole, jeħtieġ tnaqqis fid-doża għal 30 mg darba kuljum.
English: Edoxaban 60 mg was non-inferior to warfarin for the primary efficacy endpoint of stroke or SEE (upper limit of the 97.5% CI of the HR was below the prespecified non-inferiority margin of 1.38) (Table 4).
Maltese: Edoxaban 60 mg ma kienx inferjuri għal warfarin għall-punt aħħari tal-effikaċja primarja ta' puplesija jew SEE (limitu ta' fuq tan-97.5% CI tal-HR kien taħt il-marġni ta' noninferjorità speċifikata minn qabel ta' 1.38) (Tabella 4).
English: Patients with mild or moderate hepatic impairment exhibited comparable pharmacokinetics and pharmacodynamics to their matched healthy control group.
Maltese: Pazjenti b'indeboliment ħafif jew moderat tal-fwied urew farmakokinetika u farmakodinamika komparabbli mal-grupp ta' kontroll imqabbel tagħhom.
English: Magyarország MSD Pharma Hungary Kft. Tel.: +36 1 888-5300
Maltese: MSD Polska Sp. z o.o. Tel: +48 22 549 51 00
English: P-gp inhibitors
Maltese: Inibituri ta' P-gp
English: Haemodialysis
Maltese: FARMAĊEWTIKU
English: NAME OF THE MEDICINAL PRODUCT Lixiana 60 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI FOLJA TAD-DOŻA TAL-UNITÀ (10 x 1 PILLOLI)
English: In clinical studies, co-administration of NSAIDs resulted in increased clinically relevant bleeding.
Maltese: Fl-istudji kliniċi, l-għoti flimkien ta' NSAIDs irriżulta f'żieda klinikament rilevanti ta' emorraġija.
English: PHARMACEUTICAL FORM AND CONTENTS 10 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 10 pilloli miksija b'rita
English: Investigations Liver function test abnormal
Maltese: Investigazzjonijiet Test tal-funzjoni tal-fwied b'riżultat anormali
English: Subcutaneous anticoagulant (i.e.: LMWH, fondaparinux): Discontinue subcutaneous anticoagulant and start Lixiana at the time of the next scheduled subcutaneous anticoagulant dose.
Maltese: Meta tibdel minn Lixiana għal antikoagulanti parenterali (eż. eparin) Waqqaf it-teħid ta' Lixiana u ibda l-antikoagulant parenterali (eż. eparina) fil-ħin tad-doża skedata ta' Lixiana li jkun imiss.
English: In vitro plasma protein binding is approximately 55%.
Maltese: Ir-rabta ma' proteini in vitro fil-plażma hu ta' madwar 55%.
English: NAME OF THE MEDICINAL PRODUCT Lixiana 15 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Maltese: Waqqaf l-antikoagulant taħt il-ġilda u ibda Lixiana fil-ħin tad-doża skedata li jkun imiss talantikoagulant taħt il-ġilda.
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
Maltese: neoplażmi malinni f'riskju għoli ta' emorraġija, korriment reċenti fil-moħħ jew fis-sinsla, kirurġija reċenti fil-moħħ, fis-sinsla jew fl-għajnejn, emorraġija reċenti fil-kranju, variċi flesofagu magħrufa jew issuspettati, malformazzjonijiet arterjovenużi, anewriżmi vaskulari jew anormalitajiet vaskulari maġġuri fis-sinsla jew fil-moħħ.
English: The efficacy results for pre-specified major subgroups (with dose reduction as required), including age, body weight, gender, status of renal function, prior stroke or TIA, diabetes and P-gp inhibitors were generally consistent with the primary efficacy results for the overall population studied in the trial.
Maltese: Ir-riżultati tal-effikaċja għal sottogruppi maġġuri speċifikati minn qabel (bi tnaqqis fid-doża skont ilħtieġa), li jinkludu l-età, il-piż tal-ġisem, is-sess tal-persuna, l-istat tal-funzjoni tal-kliewi, puplesija jew TIA fil-passat, dijabete u inibituri ta' P-gp, kienu ġeneralment konsistenti mar-riżultati taleffikaċja primarja għall-popolazzjoni globali studjata fil-prova.
English: NAME OF THE MEDICINAL PRODUCT Lixiana 30 mg film-coated tablets edoxaban NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (logo) EXPIRY DATE
Maltese: Din il-mediċina tgħin sabiex timpedixxi milli jiffurmaw emboli tad-demm.
English: To
Maltese: Minn
English: Although treatment with edoxaban does not require routine monitoring, the effect on anticoagulation can be estimated by a calibrated quantitative anti-Factor Xa assay which may help to inform clinical decisions in particular situations as, e.g. overdose and emergency surgery (see also section 5.2).
Maltese: Xa kwantitattiv kkalibrat li jista' jgħin biex joffri informazzjoni f'deċiżjonijiet kliniċi f'sitwazzjonijiet partikulari bħal e.ż. doża eċċessiva u kirurġija ta' emerġenza (ara wkoll sezzjoni 5.2).
English: Although treatment with edoxaban does not require routine monitoring, the effect on anticoagulation can be estimated by a calibrated quantitative anti-Factor Xa assay which may be useful in exceptional situations where knowledge of edoxaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery (see also section 4.4).
Maltese: Xa li jista' jkun utli f'sitwazzjonijiet eċċezzjonali fejn l-għarfien tal-esponiment ta' edoxaban jista' jgħin biex jinforma deċiżjonijiet kliniċi, eż., doża eċċessiva u operazzjoni ta' emerġenza (ara wkoll sezzjoni 4.4).
English: For the subjects who were dose reduced to 30 mg (predominantly low body weight or renal function) 15 (2.1%) edoxaban and 22 (3.1%) of warfarin subjects had a recurrent VTE [HR (95% CI): 0.69
Maltese: Għall-individwi li tnaqqsitilhom id-doża għal 30 mg (fil-biċċa l-kbira tagħhom kellhom piż baxx talġisem jew funzjoni tal-kliewi baxxa) 15 (2.1%) edoxaban u 22 (3.1%) tal-individwi li kienu fuq warfarin kellhom VTE rikorrenti [HR (95% CI): 0.69 (0.36, 1.34)].
English: It is only indicated in the process of switching from Lixiana 30 mg (patients with one or more clinical factors for increased exposure; see table 1) to VKA, together with an appropriate VKA dose (see table 2, section 4.2).
Maltese: Hu indikat biss fil-proċess ta' qlib minn Lixiana 30 mg (f'pazjenti b'fatturi kliniku wieħed jew aktar għal żieda fl-esponiment; ara tabella 1) għal VKA, flimkien ma' doża VKA adattata (ara tabella 2, sezzjoni
English: Changing from Lixiana to parenteral anticoagulants (e.g. heparin)
Maltese: Eparina mhux frazzjonata ġol-vini (UFHunfractionated heparin):
English: Ref. EMEA/254399/2009
Maltese: EMEA/410313/2009 EMEA/H/C/1052
English: It was to be available as tablets (75 mg).
Maltese: Hija disponibbli f'pilloli (75 mg).
English: What is Clopidogrel Teva Pharma?
Maltese: X'inhu Clopidogrel Teva Pharma?
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Teva Pharma huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: The active substance in Clopidogrel Teva Pharma and in Plavix, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva fi Clopidogrel Teva Pharma u fi Plavix, clopidogrel, hu inibitur tal-aggregazzjoni tal-pjastrini (platelets).
English: Clopidogrel Teva Pharma was developed as a ‘generic medicine'.
Maltese: Clopidogrel Teva Pharma ġie żviluppat bħala ‘mediċina ġenerika'.
English: On 22 April 2009, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Clopidogrel Teva Pharma, for the prevention of atherothrombotic events in patients who have myocardial infarction, ischaemic stroke or established peripheral arterial disease.
Maltese: Fit-22 t'April 2009, Teva Pharma B.V. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-modifika flawtorizzazzjoni għat-tqegħid fis-suq għal Clopidogrel Teva Pharma, għal prevenzjoni ta' każijiet aterotrombotiċi f'pazjenti li għandhom infarti mijokardijaċi, puplesija iskemika jew mard periferiku stabbilit tal-arterji.
English: Clopidogrel Teva Pharma was expected to be used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel Teva Pharma kien mistenni li jintuża f'pazjenti adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis ta' l-arterji).
English: Questions and answers on the withdrawal of the marketing authorisation application for Clopidogrel Teva Pharma clopidogrel
Maltese: Mistoqsija u tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Clopidogrel Teva Pharma clopidogrel
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Clopidogrel Teva Pharma could not have been approved for the prevention of atherothrombotic events in patients who have had myocardial infarction, ischaemic stroke or who have established peripheral arterial disease.
Maltese: Ibbażat fuq analiżi tad-dejta u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Clopidogrel Teva Pharma ma setax jiġi approvat għal prevenzjoni ta' każijiet aterotrombotiċi f'pazjenti li għandhom infarti mijokardijaċi, puplesija iskemika jew mard periferiku stabbilit tal-arterji.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għall-aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsija u tweġiba hawn.
English: The CHMP concluded that the studies presented did not provide enough evidence to show that Clopidogrel Teva Pharma was bioequivalent to the reference medicine Plavix.
Maltese: Is-CHMP ikkonkluda li l-istudji ppreżentati ma tawx biżżejjed evidenza li turi li Clopidogrel Teva Pharma kien bijoekwivalenti għall-mediċina ta' referenza Plavix.
English: This means that Clopidogrel Teva Pharma was intended to be similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Clopidogrel Teva Pharma huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: At this point in time, the CHMP was of the opinion that Clopidogrel Teva Pharma could not be considered a generic medicine of Plavix, the reference medicinal product.
Maltese: Clopidogrel Teva Pharma kien mistenni li jaħdem bl-istess mod bħala mediċina ta' referenza, Plavix.
English: It was to be used in patients who had recently had a myocardial infarction (heart attack) or an ischaemic stroke (non-bleeding stroke), or in patients with peripheral arterial disease (problems with blood flow in the arteries).
Maltese: Kellu jintuża f'pazjenti li reċentement kellhom infart mijokarijaku (attakk tal-qalb) jew puplesija iskemika (puplesija bla emoraġġija) jew f'pazjenti b'mard periferiku fl-arterji) (problemi fil-fluss tad-demm flarterji).
English: How is Clopidogrel Teva Pharma expected to work?
Maltese: Kif kien mistenni li jaħdem Clopidogrel Teva Pharma?
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Fuq il bażi tar-reviżjoni tad-dokumentazzjoni inizjali, is-CHMP jħejji lista ta' mistoqsijiet fil-jum 120, limbagħad tintbagħat lill-kumpanija.