FrancophonIA/ELRC3.0 huggingface dataset:
English: Salicylate metabolism is saturable and total body clearance decreases at higher serum concentrations due to the limited ability of the liver to form both salicyluric acid and phenolic glucuronide.
Maltese: Hemm limitu ta' kemm jista' jiġi metabolizzat salicylic acid u t-tneħħija totali mill-ġisem tonqos meta jogħlew ilkonċentrazzjonijiet tas-serum minħabba l-kapaċità limitata tal-fwied li jifforma kemm salicyluric acid u glukuronidu fenoliku.
English: Acetylsalicylic acid inhibits platelet aggregation by irreversible inhibition of prostaglandin cyclo-oxygenase and thus inhibits the generation of thromboxane A2, an inducer of platelet aggregation and vasoconstriction.
Maltese: Acetylsalicylic acid jinibixxi l-aggregazzjoni ta' plejtlits permezz tal-inibizzjoni b'mod irriversibbli tal-prostaglandin cyclo-oxygenase u b'hekk jiġi inibit il-produzzjoni ta' thromoxane A2, li hija ssustanza li tikkawża l-aggregazzjoni tal-plejtlits u l-vasokostrizzjoni.
English: The ASA in the combination of clopidogrel/acetylsalicylic acid is rapidly hydrolyzed in plasma to salicylic acid, with a half-life of 0.3 to 0.4 hours for ASA doses from 75 to 100 mg. Salicylic acid is primarily conjugated in the liver to form salicyluric acid, a phenolic glucuronide, an acyl glucuronide, and a number of minor metabolites.
Maltese: L-ASA fil-kombinazzjoni ta' clopidogrel/acetylsalicylic acid, malajr jiġi idrolizzat fil-plażma għal salicylic acid, b'half-life ta' 0.3 sa 0.4 sigħat għal dożi ta' ASA minn 75 mg sa 100 mg.
English: The incidence of major bleeding was similar between groups.
Maltese: L-inċidenza ta' fsada maġġuri kienet simili bejn il-gruppi .
English: • rashes
Maltese: • raxxijiet
English: Patients should be evaluated for history of hypersensitivity to another thienopyridine (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu evalwati għal storja ta' sensittività eċċessiva għal thienopyridines (bħal clopidogrel, ticlopidine, prasugrel) minħabba li ġiet irrappurtata reattività inkroċjata fost thienopyridines (ara sezzjoni 4.8).
English: Tablet coating:
Maltese: Kisi tal-pillola:
English: Pack size of 30 film-coated tablets.
Maltese: Daqs tal-pakkett ta' 30 pillola miksijin b'rita.
English: Clopidogrel/Acetylsalicylic acid Teva is a fixed-dose combination medicinal product for continuation of therapy in:
Maltese: Clopidogrel/Acetylsalicylic acid Teva huwa prodott mediċinali ta' kombinazzjoni b'doża fissa sabiex titkompla t-terapija fi:
English: The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8).
Maltese: L-inċidenza tad-dmija klinikament sinifikanti kienet simili għal dik osservata meta sustanzi trombolitiċi u eparina jingħataw flimkien ma' ASA (ara sezzjoni 4.8).
English: Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 30,000 patients treated with clopidogrel plus ASA, and over 9,000 patients treated for 1 year or more.
Maltese: Clopidogrel ġie evalwat għas-sigurtà f'iktar minn 42,000 pazjent li ħadu sehem fi studji kliniċi, inklużi iktar minn 30,000 pazjent ikkurati b'clopidogrel flimkien ma' ASA u aktar minn 9,000 pazjent li kienu kkurati għal sena jew iktar.
English: As a precaution, concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti ta' inibituri qawwijin jew moderati ta' CYP2C19 għandu jiġi skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Investigations
Maltese: Epistassi
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: platelet aggregation inhibitors excl. Heparin, ATC Code: B01AC30.
Maltese: L-effetti kemm farmakokinetiċi kif ukoll dawk kontra l-plejtlits tal-metabolit attiv ta' clopidogrel, kif imkejla b'analiżi.ex vivo tal-aggregazzjoni tal-plejtlis, jinbidlu skont il-ġenotip ta' CYP2C19.
English: • sore mouth (stomatitis)
Maltese: • rimettar (tkun ma tiflaħx)
English: Initial hyperventilation leads to respiratory alkalosis.
Maltese: L-ewwel ikun hemm liperventilazzjoni li twassal għall-alkalożi respiratorja.
English: Clopidogrel/Acetylsalicylic acid Teva is used following initiation of therapy with clopidogrel and ASA given separately.
Maltese: Clopidogrel/Acetylsalicylic acid Teva jintuża wara li l-ewwel tkun inbdiet it-terapija b'clopidogrel u ASA mogħtija b'mod separat.
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Maltese: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg pilloli Clopidogrel/Acetylsalicylic acid
English: You have been prescribed Clopidogrel/Acetylsalicylic acid Teva in place of the two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have experienced a severe type of chest pain known as ‘unstable angina' or heart attack (myocardial infarction).
Maltese: Ingħatajt Clopidogrel/Acetylsalicylic acid Teva minflok ma tingħata żewġ mediċini separati, clopidogrel u ASA, biex jgħin biex ma jifformawx ċapep tad-demm u dan għaliex kellek uġigħ sever f'sidrek magħruf bħala ‘unstable angina' jew ‘myocardial infarction' (attakk ta' qalb).
English: Other concomitant therapy with clopidogrel
Maltese: Terapija oħra meħuda flimkien ma' clopidogrel
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Maltese: • Għandek ukoll tgħid minnufih lit-tabib tiegħek jekk toħroġlok xi kundizzjoni medika (magħrufa wkoll bħala Purpura Tromboċitopenika Trombotika jew PTT) li tinkludi deni u tbenġil taħt il-ġilda li jista' jidher bħala ponot zgħar ħomor flimkien ma' jew mingħajr għeja kbira, konfużjoni, sfurija tal-ġilda jew tal-għajnejn (suffejra) li jkunu bla spjegazzjoni (ara sezzjoni 4 ‘Effetti sekondarji possibbli').
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Maltese: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg pilloli Clopidogrel/Acetylsalicylic acid
English: Hearing loss* or tinnitus*
Maltese: Telf tas-smigħ* jew żanżin fil-widnejn (tinnitus)*
English: In one study, when a single dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81 mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred.
Maltese: F'studju wieħed, fejn doża waħda ta' ibuprofen 400 mg ġiet meħuda sa 8 sigħat qabel jew sa 30 minuta wara dożaġġ ta' asperina (81 mg) li taħdem b'mod immedjat, ntwera li kien hemm tnaqqis fl-effett ta' ASA fuq il-produzzjoni ta' thrombaxane jew fuq l-aggregazzjoni tal-plejtlits.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Maltese: Kull pillola miksija b'rita fiha 75 mg of clopidogrel (bħala hydrogen sulphate) u 100 mg ta' acetylsalicylic acid (ASA).
English: Due to the presence of ASA, the combination of clopidogrel/acetylsalicylic acid is contraindicated during the third trimester of pregnancy.
Maltese: Minħabba li fih ASA, il-kombinazzjoni ta' clopidogrel/acetylsalicylic acid hija kontra-indikata waqt it-tielet trimestru tat-tqala.
English: • fever
Maltese: • suffejra
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Maltese: Kull pillola fiha 75 mg ta' clopidogrel (bħala hydrogen sulphate) u 75 mg ta' acetylsalicylic
English: At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
Maltese: F'dożi għolja ħafna, ġiet irrapurtata tollerabilità baxxa fiż-żaqq (gastrite, erożjonijiet gastriċi u/jew rimettar) ta' clopidogrel fil-firien u l-babwini.
English: Acute renal impairment (especially in patients with existing renal impairment, heart decompensation, nephritic syndrome, or concomitant treatment with diuretics)*, glomerulonephritis, blood creatinine increased
Maltese: Indeboliment renali akut (speċjalment f'pazjenti li diġà għandhom indeboliment renali, il-qalb ma tkunx qiegħda tikkumpensa, sindromu nefritiku jew kura fl-istess ħin b'dijuretiċi)*, glomerulonefrite, jiżdied il-livell tal-krejatinin fiddemm.
English: Light pink to pink, film-coated capsule shaped tablets.
Maltese: Pilloli roża ċari għal roża, għamla ta' kapsula, miksijin b'rita.
English: Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole.
Maltese: Ikun hemm ukoll l-aċidożi metabolika minħabba l-presenza tas-saliċilati.
English: The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Maltese: Ir-riżultati f'popolazzjonijiet b'karatteristiċi differenti (eż. anġina instabbli jew MI ta' mewġa mhux Q, minn livelli baxxa sa għolja ta' riskju, dijabete, il-bżonn ta' revaskularizzazzjoni, età, sess, eċċ.) kienu konsistenti mar-riżultati tal-analiżi primarja.
English: The combination of clopidogrel/acetylsalicylic acid should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Maltese: Il-kombinazzjoni ta' clopidogrel/acetylsalicylic acid m'għandhiex tintuża f'pazjenti b'indeboliment renali sever (ara sezzjoni 4.3).
English: Cross-reactions among thienopyridines
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI
English: • Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous
Maltese: • Sindromu koronarju akut mingħajr ma jkun elevat is-segment ST (anġina instabbli jew infart mijokardijaku mingħajr il-mewġa-Q) inklużi l-pazjenti fi proċess li titpoġġa stent wara intervent
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Maltese: Emorraġija gastrointestinali u minn wara lperitonew b'eżitu fatali, pankreatite.
English: The combination of clopidogrel/acetylsalicylic acid is
Maltese: Il-kombinazzjoni ta' clopidogrel/acetylsalicylic acid mhijiex rakkomandata
English: Renal excretion of unchanged active substance depends upon urinary pH. As urinary pH rises above 6.5, the renal clearance of free salicylate increases from <5% to >80%.
Maltese: Hekk kif il-pH tal-awrina togħla 'l fuq minn 6.5, it-tneħħija renali ta' salicylate li ma jkunx f'rabta mal-proteini jiżdied minn <5 % sa >80 %.
English: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Peress li parti mill-metaboliżmu ta' clopidogrel għall-metabolit attiv tiegħu jsir minn CYP2C19, huwa mistenni li l-użu ta' prodotti mediċinali li jinibixxu l-attività ta' din l-enzima jwasslu għal tnaqqis fillivell tal-metabolit attiv ta' clopidogrel.
English: Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Maltese: Omeprazole 80 mg mogħti darba kuljum jew fl-istess ħin ma' clopidogrel jew b'differenza ta' 12-il siegħa bejn it-teħid taż-żewġ mediċini naqqas l-espożizzjoni tal-metabolit attiv b'45 % ( id-doża ta' kkargar) u b'40 % (id-doża ta' manteniment).
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information reported in published information for ASA (frequency “not known”).
Maltese: * Informazzjoni rrappurtata f'informazzjoni ppubblikata għal ASA bi frekwenza “mhux magħrufa”.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali (ara sezzjoni 6.1.
English: How to store Clopidogrel/Acetylsalicylic acid Teva
Maltese: X'fih Clopidogrel/Acetylsalicylic acid Teva
English: In CURE there was no excess in major bleeds with clopidogrel plus ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery.
Maltese: Jekk għal żmien temporanju l-pazjenti jkollhom iwaqqfu tterapija kontra l-plejtlits, il-kombinazzjoni ta' clopidogrel/acetylsalicylic acid għandha titwaqqaf 7 ijiem qabel il-kirurġija.
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Maltese: Meta l-metabolizzaturi dgħajfa rċevew issistema ta' dożaġġ ta' 600 mg/150 mg, l-espożizzjoni tal-metabolit attiv kienet akbar milli bissistema ta' dożaġġ ta' 300 mg/75 mg.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji b'frekwenza mhux magħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli):
English: Neutropenia, including severe neutropenia
Maltese: Newtropenija, li tinkludi newtropenija severa
English: At high ASA doses, the elimination of salicylic acid follows zero-order kinetics (i.e., the rate of elimination is constant in relation to plasma concentration), with an apparent half-life of 6 hours or higher.
Maltese: F'dożi għolja ta' ASA, l-eliminazzjoni ta' salicylic acid issegwi kinetika tat-tip zeroorder (jiġifieri, ir-rata ta' eliminazzjoni hija kostanti fir-rigward tal-konċentrazzjoni fil-plażma), b'half-life apparenti ta' 6 sigħat jew iżjed.
English: A pharmacodynamic interaction between the combination of clopidogrel/acetylsalicylic acid and heparin is possible, leading to increased risk of bleeding.
Maltese: Huwa possibbli li jkun hemm interazzjoni farmakodinamika bejn il-kombinazzjoni ta' clopidogrel/acetylsalicylic acid u l-eparina, li tista' twassal għal riskju ikbar ta' dmija.
English: • itching
Maltese: • stitikezza
English: It is unknown whether ASA alters fertility.
Maltese: Mhuwiex magħruf jekk ASA jikkawżax tibdil fil-fertilità.
English: There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Maltese: Ma kienx hemm evidenza ta' riskju ta' kanċer meta clopidogrel ingħata għal 78 ġimgħa lill-ġrieden u 104 ġimgħa mill-firien meta dawn ingħataw dożi sa 77 mg/kg kuljum (li jirrappreżenta espożizzjoni mill-inqas 25 darba dik osservata fil-bnedmin li kienu qed jingħataw doża klinika ta' 75 mg/jum).
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Maltese: • Kull pillola fiha 75 mg ta' clopidogrel (bħala hydrogen sulphate) u 100 mg ta' acetylsalicylic
English: Clopidogrel/Acetylsalicylic acid Teva contains lactose If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Maltese: Clopidogrel/Acetylsalicylic acid Teva fih il-lactose Jekk it-tabib qallek li għandek xi intolleranza għal ċerti tipi ta' zokkor (eż. lactose), ikkuntattja lit-tabib tiegħek qabel tieħu din il-mediċina.
English: After repeated doses of 75 mg clopidogrel per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.
Maltese: Wara dożi ripetuti ta' 75 mg clopidogrel kuljum għal 10 ijiem f'pazjenti b'indeboliment epatiku sever, l-inibizzjoni tat-tgħaqqid f'massa tal-plejtlits kawża tal-ADP kien simili għal dak osservat f'suġġetti b'saħħithom.
English: 2 capsules
Maltese: 2 kapsuli
English: Sachet (PET/Alu/LLDPE)
Maltese: Qartas (PET/Alu/LLDPE)
English: 1 capsule (125 mg) + 2 capsules (80 mg)
Maltese: Kapsula, iebsa kapsula 1 (125 mg) + 2 kapsuli (80 mg)
English: 125 mg Powder for oral suspension
Maltese: 125 mg Trab għal suspensjoni orali
English: 1 sachet + 2 dispensers + 1 cap + 1 mixing cup
Maltese: qartas 1 + dispensers 2 + għatu 1 + tazza 1 fhiex tħallat
English: The marketing authorisation holders should provide convincing and robust data to identify a patient population in which the clinical benefits of ketoconazole-containing products for oral use clearly outweigh the risks.
Maltese: Id-detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq għandu/għandhom jipprovdi/jipprovdu dejta konvinċenti u robusta li tidentifika popolazzjoni ta' pazjenti li fihom il-benefiċċji kliniċi tal-prodotti li fihom ketoconazole għall-użu orali jegħlbu r-riskji b'mod ċar.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istat(i) Membru(i) jew tal-Istat(i) Membru(i) ta' Referenza jekk applikabbli, għandhom jassiguraw li l-kundizzjonijiet li ġejjin ikunu ssodisfati mid-detentur(i) talawtorizzazzjoni għat-tqegħid fis-suq:
English: Annex III Conditions for lifting the suspension of the Marketing Authorisation(s)
Maltese: Anness III Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-Awtorizzazzjoni(jiet) għat-Tqegħid fis-Suq
English: Conditions for lifting the suspension of the Marketing Authorisation(s)
Maltese: Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-Awtorizzazzjoni(jiet) għat-Tqegħid fis-Suq
English: 16 September 2016 EMA/541043/2016 EMEA/H/C/0004235
Maltese: EMA/541043/2016 EMEA/H/C/0004235
English: It was to be available as tablets.
Maltese: Kellu jkun disponibbli bħala pilloli.
English: What is Cokiera?
Maltese: X'inhu Cokiera?
English: Cokiera is an antiviral medicine containing the active substances dasabuvir, ombitasvir, paritaprevir and ritonavir.
Maltese: Cokiera huwa mediċina antivirali li fiha s-sustanzi attivi dasabuvir, ombitasvir, paritaprevir and ritonavir.
English: The active substances in Cokiera are effective against hepatitis C virus genotypes 1a and 1b.
Maltese: Is-sustanzi attivi f'Cokiera huma effettivi kontra l-ġenotipi 1a u 1b tal-virus tal-epatite Ċ.
English: Dasabuvir blocks the action of an enzyme in the hepatitis C virus, called ‘NS5B RNA-dependent polymerase', which the virus needs to multiply.
Maltese: Dasabuvir jimblokka l-azzjoni ta' enzima fil-virus tal-epatite Ċ imsejħa "NS5B polimerażi dipendenti fuq RNA", li l-virus għandu bżonn biex jimmultiplika.
English: The active substances in Cokiera work in different ways.
Maltese: Is-sustanzi attivi f'Cokiera jaħdmu b'modi differenti.
English: Ombitasvir blocks the action of a protein in the hepatitis C virus called ‘NS5A' and paritaprevir blocks the action of another protein called ‘NS3/4A', both of which the virus needs to multiply.
Maltese: Ombitasvir jimblokka l-azzjoni ta' proteina fil-virus tal-epatite Ċ imsejħa "NS5A" u paritaprevir jimblokka l-azzjoni ta' proteina oħra msejħa "NS3/4A", li t-tnejn li huma għandu bżonnhom il-virus biex jimmultiplika.
English: Ritonavir itself does not have an antiviral effect on hepatitis C virus.
Maltese: Ritonavir innifisha ma għandhiex effett antivirali fuq il-virus tal-epatite Ċ.
English: What was Cokiera expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Cokiera?
English: On 3 August 2016, AbbVie Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cokiera, for the treatment of chronic hepatitis C.
Maltese: Fit-3 ta' Awwissu 2016, AbbVie Ltd għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għattqegħid fis-suq għal Cokiera, għall-kura tal-epatite Ċ kronika.
English: How is Cokiera expected to work?
Maltese: Kif huwa mistenni li jaħdem Cokiera?
English: Ritonavir, the fourth active substance, slows down the removal of paritaprevir from the body by blocking an enzyme called CYP3A that breaks down paritaprevir.
Maltese: billi jimblokka enzima msejħa CYP3A li tkisser paritaprevir.
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Il-mediċini huma bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: The CHMP considered that the data provided did not properly show how the size of meals affect absorption of the active substances from Cokiera and therefore how well Cokiera works.
Maltese: Is-CHMP ikkunsidra li d-data pprovduta ma wrietx kif suppost, kif id-daqs tal-ikliet jaffettwa lassorbiment tas-sustanzi attivi minn Cokiera u għalhekk kif jaħdem Cokiera.
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cokiera could not have been approved for the treatment of chronic hepatitis C in adults.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Cokiera ma setax jiġi approvat għall-kura tal-epatite Ċ kronika fl-adulti.
English: EMA/541043/2016
Maltese: (dasabuvir / ombitasvir / paritaprevir / ritonavir) EMA/541043/2016
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this specific product.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm ebda prova klinika kontinwa jew programm ta' użu ta' kompassjoni għal dan il-prodott speċifiku.
English: Cokiera was expected to be used for treating adults with chronic (long-term) hepatitis C. Hepatitis C is an infection of the liver caused by the hepatitis C virus.
Maltese: Cokiera kien mistenni li jintuża għall-kura tal-adulti b'epatite Ċ kronika (fit-tul).
English: Important notes:
Maltese: Noti importanti:
English: Wincentego Pola 21 58-500 Jelenia Góra, Poland
Maltese: Wincentego Pola 21 58-500 Jelenia Góra, Il-Polonja
English: Dose (mL) = patient weight (kg) x 0.0075
Maltese: Doża (mL) = piz tal-pazjent (kg) x 0.0075
English: Date of latest renewal: 27 May 2013
Maltese: Data tal-aħħar tiġdid: 27 Mejju, 2013
English: PharmaSwiss Česká republika s.r.o.
Maltese: FIS-SUQ PharmaSwiss Česká republika s.r.o.
English: A total of 136, 21, and 82 patients received at least one open-label dose in studies 301, 301EXT, and 302EXT, respectively.
Maltese: Total ta' 136, 21, u 82 pazjent irċevew minn ta' lanqas doża waħda open label fl-istudji 301, 301EXT, u 302EXT, rispettivament.
English: INFORMATION IN BRAILLE RELISTOR 8 mg
Maltese: INFORMAZZJONI BIL-BRAILLE RELISTOR 8 mg
English: Methylnaltrexone bromide does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes.
Maltese: Methylnaltrexone bromide ma jaffettwax il-farmakokinetiċi ta' prodotti mediċinali oħrajn metabolizzati bl-isoenzimi P450 (CYP) ta' cytochrome.
English: The terminal disposition half-life (t1/2) is approximately 8 hours.
Maltese: Il-half-life terminali ta' dispozizzjoni t1/2) huwa ta' madwar 8 sigħat.
English: INFORMATION IN BRAILLE RELISTOR 12 mg/0.6 mL
Maltese: INFORMAZZJONI BIL-BRAILLE RELISTOR 12 mg/0.6 mL
English: The steady-state volume of distribution (Vss) is approximately 1.1 L/kg.
Maltese: distribuzzjoni (Vss) huwa madwar 1.1 l/kg.
English: INFORMATION IN BRAILLE RELISTOR 12 mg
Maltese: INFORMAZZJONI BIL-BRAILLE RELISTOR 12 mg
English: Common: Dizziness
Maltese: Komuni: Remettar