FrancophonIA/ELRC3.0 huggingface dataset:
English: • elevations in blood tests of liver function (transaminases)
Maltese: • żidiet fit-testijiet tad-demm tal-funzjoni tal-fwied (transaminases)
English: Oval, biconvex, tan coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side.
Maltese: Pillola ovali, bikonvessa, ta' lewn kannella, 19.3 x 9.3 mm miksija b'rita b'xifer ġej għat-tond u mnaqqxa b'145/20 fuq naħa waħda u l-logo ta' Abbott fuq in-naħa l-oħra.
English: • Hypersensitivity reaction to Cholib with symptoms like: pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells)
Maltese: • reazzjoni ipersensittiva għal Cholib b'sintomi bħal: uġigħ jew infjammazzjoni fil-ġogi, infjammazzjoni tal-vini, tbenġil mhux normali, bżieżaq fuq il-ġilda u nefħa, ħorriqija, sensittività tal-ġilda għax-xemx, deni, fwawar, qtugħ ta' nifs u li tħossok ma tiflaħx, stampa ta' marda simili għal-lupus (inkluż raxx, disturbi fil-ġogi, u effetti fuq iċ-ċelloli tad-demm bojod)
English: • infection of the upper respiratory tract
Maltese: • infezzjoni tal-passaġġ respiratorju ta' fuq
English: The primary efficacy criterion was superiority of the combination fenofibrate 145 and simvastatin 20 mg versus simvastatin 40 mg on TG decrease and HDL-C increase and non-inferiority for LDL-C decrease at 12 weeks.
Maltese: Il-kriterju tal-effikaċja primarja kien is-superjorità tal-kombinazzjoni fenofibrate 145 u simvastatin 20 mg meta mqabbel ma' simvastatin 40 mg dwar it-tnaqqis tat-TG u żieda fl-HDL-C u nuqqas ta' inferjorità għal tnaqqis fl-LDL-C wara 12-il ġimgħa.
English: The pharmacokinetics of single and multiple doses of simvastatin showed that no accumulation of medicinal product occurred after multiple dosing.
Maltese: Il-farmakokinetika ta' doża unika u ta' dożi multipli ta' simvastatin wriet li ma kienx hemm akkumulazzjoni tal-prodott mediċinali wara dożi multipli.
English: Cases of interstitial lung disease have been reported with some statins and with fenofibrate, especially with long term therapy (see section 4.8).
Maltese: Każijiet ta' mard interstizjali tal-pulmun ġew irrapportati b'xi statins u b'fenofibrate, speċjalment b'terapija fit-tul (ara sezzjoni 4.8).
English: Adjust the dose of these oral anticoagulants according to INR monitoring
Maltese: Aġġusta d-doża ta' dawn l-antikoagulanti orali skont il-monitoraġġ tal-INR
English: The film-coated tablet (tablet) is a, oval, biconvex, tan coloured 19.3 x 9.3 mm tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side.
Maltese: Il-pillola miksija b'rita (pillola) hija pillola ovali, bikonvessa, ta' lewn kanella, pillola ta' 19,3 x 9,3 mm bix-xifer ġej għat-tond u mnaqqxa b'145/20 fuq naħa waħda u l-logo ta' Abbott fuq in-naħa l-oħra.
English: N Means (SD) Treatment Comparison*
Maltese: Sindromu ta' sensittività eċċessiva ***
English: Muscle disorders (e.g. myalgia, myositis, muscular spasms and weakness)
Maltese: Disturbi fil-muskoli (eż. uġigħ fil-muskoli, mijosite, spażmi u dgħjufija muskolari)
English: Therefore, Cholib is not expected to affect plasma concentrations of substances metabolised via CYP 3A4.
Maltese: Għalhekk, Cholib mhuwiex mistenni li jaffettwa l-konċentrazzjonijiet ta' sustanzi metabolizzati permezz ta' CYP 3A4 fil-plasma.
English: Immune system disorders Hypersensitivity rare
Maltese: Reazzjonijiet ta' fotosensittività rari
English: Dermatitis and eczema
Maltese: TWISSIJA(IET) SPEĊJALI
English: Paediatric population Cholib is contraindicated in children and adolescents up to 18 years old.
Maltese: Popolazzjoni pedjatrika Cholib huwa kontraindikat fit-tfal u fl-adoloxxenti taħt it-18-il sena.
English: Simvastatin is a substrate of cytochrome P450 3A4.
Maltese: Simvastatin huwa substrat taċ-ċitokromju P450
English: • itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections)
Maltese: • antikoagulanti bħal warfarina, fluindione, phenprocoumone jew acenocoumarol (mediċini li jipprevjenu l-emboli tad-demm)
English: Based on conventional animal studies regarding pharmacodynamics, repeated dose toxicity, genotoxicity and carcinogenicity, there are no other risks for the patient than may be expected on account of the pharmacological mechanism.
Maltese: Abbażi ta' studji konvenzjonali fuq l-annimali dwar il-farmakodinamika, tossiċità b'dożi ripetuti, ġenotossiċità u karċinoġeniċità, ma hemmx riskji oħra għall-pazjent li jistgħu jiġu mistennija minħabba l-mekkaniżmu farmakoloġiku.
English: The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of gemfibrozil with simvastatin.
Maltese: Ir-riskju ta' mijopatija u rabdomijolisi jiżdied b'mod sinifikanti bl-użu konkomittanti ta' gemfibrozil ma' simvastatin.
English: Cholib should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m2 (see section 4.2).
Maltese: • Insuffiċjenza renali minn moderata għal severa (rata stmata ta' filtrazzjoni glomerulari ta' < 60 mL/min/1.73 m2)
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Maltese: Kien hemm rapporti rari ħafna ta' mijopatija li tinnekrotizza medjata mis-sistema immunitarja (IMNM) waqt jew wara t-trattament b'xi statini.
English: Cholib should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m
Maltese: Cholib għandu jintuża b'kawtela f'pazjenti b'insuffiċjenza renali ħafifa b'rata stmata ta' filtrazzjoni glomerulari ta' 60 sa 89 mL/min/1.73 m
English: Because rifampicin is a potent CYP 3A4 inducer that interferes with simvastatin metabolism, patients undertaking long-term rifampicin therapy (e.g. treatment of tuberculosis) may experience loss of efficacy of simvastatin.
Maltese: Minħabba li rifampicin huwa induttur qawwi ta' CYP 3A4 li jinterferixxi mal-metaboliżmu ta' simvastatin, pazjenti li qegħdin jieħdu terapija fit-tul ta' rifampicin (eż. kura għat-tuberkolożi) jistgħu jesperjenzaw telf fl-effikaċja ta' simvastatin.
English: Blood creatinine increased: 10% of patient had a creatinine increase from baseline greater than 30 µmol/L with co-administered fenofibrate and simvastatin versus 4.4% with statin monotherapy.
Maltese: Żieda fil-kreatinina fid-demm: 10% tal-pazjenti kellhom żieda fil-kreatinina mil-linja bażi akbar minn 30 µmol/L bl-għoti flimkien ta' fenofibrate u simvastatin kontra 4.4% b'monoterapija b'statin. 0.3% tal-pazjenti li kienu qed jirċievu l-għoti flimkien kellhom żidiet klinikament rilevanti fil-kreatinina għal valuri ≥ 200 µmol/l.
English: The risk of high dose (80 mg) simvastatin related myopathy is about 1 % in general, without genetic testing.
Maltese: Irriskju ta' mijopatija relatata ma' doża għolja (80 mg) ta' simvastatin huwa madwar 1% b'mod ġenerali,
English: Concomitant intake of large quantities (over 1 liter daily) of grapefruit juice and simvastatin resulted in a 7-fold increase in plasma exposure to simvastatin acid.
Maltese: It-teħid konkomittanti ta' kwantitajiet kbar (aktar minn litru 1 kuljum) ta' meraq tal-grejpfrut u simvastatin irriżulta f'żieda fl-espożizzjoni għal simvastatin acid fil-plasma ta' 7 darbiet.
English: Therefore, the co-administration of Cholib with gemfibrozil, other fibrates, or statins is contraindicated (see section 4.3).
Maltese: Għalhekk, l-għoti flimkien ta' Cholib ma' gemfibrozil, fibrati oħra, jew statins huwa kontraindikat (ara sezzjoni 4.3).
English: • Concomitant administration of fibrates, statins, danazol, ciclosporin or potent cytochrome
Maltese: • L-għoti konkomittanti ta' fibrati, statins, danazol, ciclosporin jew inibituri qawwija taċ-ċitokromju P450 (CYP) 3A4 (ara sezzjoni 4.5)
English: Nervous system disorders Headache uncommo n
Maltese: Dermatite u ekżema mhux komuni
English: LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high affinity LDL receptor.
Maltese: LDL jiġi ffurmat minn proteina b'densità baxxa ħafna (VLDL) u jiġi kkatabolizzat prinċipalment mir-riċettur b'affinità għolja għal-LDL.
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination.
Maltese: Kien hemm rapporti ta' rabdomijoliżi (inkluż xi fatalitajiet) f'pazjenti li rċivew din il-kombinazzjoni.
English: • Unexplained muscle pain, tenderness, or weakness may be sign of muscle break down.
Maltese: • Uġigħ, sensittività, jew dgħjufija fil-muskoli mhux mistennija jistgħu jkunu sinjal ta' deterjorament tal-muskoli.
English: Patients
Maltese: Il
English: EMA/214091/2016 EMEA/H/C/001241
Maltese: EMA/61037/2016 EMA/H/C/001241
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom taking Brilique should also be taking aspirin as directed by their doctor.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom pazjenti għandhom jieħdu wkoll aspirina skont l-istruzzjonijiet tat-tabib.
English: The full EPAR for Brilique can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Wieħed jista' jfittex l-EPAR sħiħ għal Brilique fuq is-sit web tal-Aġenzija website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (60 and 90 mg).
Maltese: Jiġi bħala pilloli (60 u 90 mg).
English: Brilique is a medicine that contains the active substance ticagrelor.
Maltese: Brilique huwa mediċina li fiha s-sustanza attiva ticagrelor.
English: This is a summary of the European public assessment report (EPAR) for Brilique.
Maltese: Dan huwa sommarju tar-rapport ta' valutazzjoni pubblika Ewropew (EPAR) għal Brilique.
English: Other information about Brilique
Maltese: Informazzjoni oħra dwar Brilique
English: The active substance in Brilique, ticagrelor, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva fi Brilique, it-ticagrelor, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: These are medicines such as ketoconazole (used to treat fungal infections), clarithromycin (an antibiotic), atazanavir and ritonavir (medicines used in HIV-positive patients) and nefazodone (used to treat depression).
Maltese: Dawn huma mediċini bħal ketoconazole (użat biex jikkura infezzjonijiet fungali), clarithromycin (antibijotiku), atazanavir u ritonavir (mediċini użati biex jikkuraw pazjenti li huma pożittivi għall-HIV) u nefazodone (użat biex jikkura d-dipressjoni).
English: Patients took Brilique twice a day in a dose of either 60 mg or 90 mg.
Maltese: Ilpazjenti ħadu Brilique darbtejn kuljum f'doża ta' 60 mg jew 90 mg.
English: The CHMP considered that in patients with acute coronary artery syndrome, Brilique at a dose of 90 mg twice daily and given with aspirin, reduces the risk of atherothrombotic events such as heart attack, stroke and death from a cardiovascular event.
Maltese: Is-CHMP ikkunsidra li fil-pazjenti bis-sindromu koronarju akut, Brilique, f'doża ta' 90 mg darbtejn kuljum u mogħti flimkien mal-aspirina, inaqqas ir-riskju ta' episodji aterotrombotiċi bħal attakk talqalb, puplesija u mewt minħabba episodju kardjovaskulari.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Brilique on 3 December 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Brilique fit-3 ta' Diċembru 2010.
English: In the first main study (in patients with acute coronary syndrome), 9.3% of the patients taking Brilique had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.
Maltese: Fl-ewwel studju ewlieni (fil-pazjenti bis-sindromu koronarju akut), 9.3% tal-pazjenti li kienu qed jieħdu Brilique kellhom attakk tal-qalb ieħor, puplesija jew mietu minħabba marda kardjovaskulari meta mqabbla ma' 10.9% li kienu qed jieħdu clopidogrel.
English: Brilique was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina.
Maltese: Brilique tqabbel ma' clopidogrel (inibitur ieħor ta' aggregazzjoni tal-pjastrini) fi studju prinċipali li fih ħadu sehem aktar minn 18,000 adult li kellhomm attakk tal-qalb jew li kellhom anġina mhux stabbli.
English: Why has Brilique been approved?
Maltese: Għaliex ġie approvat Brilique?
English: In the second main study (in patients with a history of the heart attack), 7.8% of patients taking Brilique 60 mg twice a day had another heart attack, stroke or died from cardiovascular disease compared with 9.0% of patients taking placebo.
Maltese: Fit-tieni studju ewlieni (fil-pazjenti li fil-passat kellhom attakk tal-qalb), 7.8% tal-pazjenti li kienu qed jieħdu Brilique ta' 60 mg darbtejn kuljum kellhom attakk tal-qalb ieħor, puplesija jew mietu minħabba marda kardjovaskulari meta mqabbla ma' 9.0% tal-pazjenti li kienu qegħdin jieħdu plaċebo.
English: For patients with acute coronary syndrome, the starting dose of Brilique is two 90-mg tablets taken at once, followed by a regular dose of one 90-mg tablet twice a day.
Maltese: Għall-pazjenti bis-sindromu koronarju akut, id-doża tal-bidu ta' Brilique hija żewġ pilloli ta' 90-mg meħudin f'daqqa, segwita minn doża regolari ta' pillola waħda ta' 90-mg li tittieħed darbtejn kuljum.
English: How has Brilique been studied?
Maltese: Kif ġie studjat Brilique?
English: How does Brilique work?
Maltese: Għal xiex jintuża Brilique?
English: What is the risk associated with Brilique?
Maltese: X'inhu r-riskju assoċjat ma' Brilique?
English: What benefit has Brilique shown during the studies?
Maltese: Liema benefiċċju wera Brilique waqt l-istudji?
English: Brilique is used together with aspirin (acetylsalicylic acid) to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes.
Maltese: Brilique jintuża flimkien mal-aspirina (aċidu aċetilsaliċiliku) biex jimpedixxi episodji aterotrombotiċi (problemi kkawżati mill-emboli tad-demm u l-ebusija tal-arterji) bħal attakki tal-qalb jew puplesiji.
English: In another main study, Brilique was compared with placebo (a dummy treatment) in over 21,000 adults who had a heart attack one to three years previously and were at high risk of an atherothrombotic event.
Maltese: Fi studju prinċipali ieħor, Brilique tqabbel ma' plaċebo (kura finta) f'aktar minn 21,000 adult li kellhom attakk tal-qalb minn sena sa tliet snin qabel u li kienu f'riskju għoli ta' episodju aterotrombotiku.
English: What is Brilique?
Maltese: Kif jaħdem Brilique?
English: The most common side effects with Brilique (seen in more than 1 patient in 10) are dyspnoea (difficulty breathing), bleeding and raised uric acid level in the blood.
Maltese: L-effetti sekondarji l-aktar komuni rrappurtati bi Brilique (li dehru f'aktar minn pazjent 1 minn kull 10) huma dispnea (diffikultà biex tieħu n-nifs), fsada u żieda fil-livell ta' aċidu uriku fid-demm.
English: For patients who have had a heart attack a year or more ago (but less than 2 years ago) and are at high risk of an atherothrombotic event, the dose of Brilique is one 60-mg tablet twice a day.
Maltese: Għall-pazjenti li kellhom attakk tal-qalb sena ilu jew aktar (iżda inqas minn sentejn ilu) u qegħdin f'riskju għoli ta' episodju aterotrombotiku, id-doża ta' Brilique hija pillola ta' 60-mg darbtejn kuljum.
English: It is used in adults with acute coronary syndrome, a group of conditions in which blood flow in the vessels supplying the heart is blocked so heart tissue cannot work properly or dies, and which includes heart attack and unstable angina (a severe type of chest pain).
Maltese: Jintuża fl-adulti bis-sindromu koronarju akut, grupp ta' kundizzjonijiet li fihom il-fluss tad-demm filvażijiet li jissupplixxu l-qalb ikun blukkat u għalhekk it-tessut tal-qalb ma jistax jaħdem kif suppost jew imut, u li jinkludu attakk tal-qalb jew anġina mhux stabbli(tip sever ta' uġigħ fis sider).
English: The patients also took aspirin and were treated for up to a year.
Maltese: Il-pazjenti ħadu wkoll aspirina u ġew ikkurati għal massimu ta' sena.
English: For the full list of restrictions with Brilique, see the package leaflet.
Maltese: Għal-lista sħiħa tar-restrizzjonijiet bi Brilique, ara l-fuljett ta' tagħrif.
English: For the full list of all side effects reported with Brilique, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati bi Brilique, ara l-fuljett ta' tagħrif.
English: Benefit regarding heart attack, stroke and death from a cardiovascular event has also been shown in patients who had a heart attack at least one year ago and have a high risk of an atherothrombotic event and a lower 60 mg dose twice daily dose is recommended for these patients.
Maltese: Il-benefiċċju fir-rigward ta' attakk tal-qalb, puplesija u mewt minħabba episodju kardjovaskulari ntwera fil-pazjenti li minn tal-inqas sena ilu kellhom attakk tal-qalb u li qegħdin f'riskju għoli għal episodju aterotrombotiku u doża inqas ta' 60 mg darbtejn kuljum hija rrakkomandata għal dawn il-pazjenti.
English: The patients also took aspirin and were treated for up to 3 years.
Maltese: Il-pazjenti ħadu wkoll l-aspirina u ġew ikkurati għal massimu ta' 3 snin.
English: EMA/658100/2014 EMEA/H/C/001138
Maltese: EMEA/H/C/001138
English: The full EPAR for Clopidogrel BGR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Clopidogrel BGR is a ‘generic medicine'.
Maltese: Clopidogrel BGR huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zylagren on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Zylagren valida fl-UE kollha fil-21 ta' Settembru 2009.
English: Previously known as Zylagren
Maltese: Preċedentement magħruf bħala Zylagren.
English: The standard dose of Clopidogrel BGR is one 75 mg tablet once a day.
Maltese: Id-doża standard ta' Clopidogrel BGR hija pillola waħda ta' 75 mg darba kuljum.
English: The active substance in Clopidogrel BGR, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel BGR, klopidogrel, hu inibitur tal-aggregazzjoni tal-pjastrini.
English: Clopidogrel BGR is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel BGR jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel BGR has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel BGR wera li għandu kwalità kumparabbli ma' Plavix u li huwa bijoekwivalenti għalih.
English: Because Clopidogrel BGR is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel BGR huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw ilbijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: Clopidogrel BGR is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel BGR huwa mediċina li fiha s-sustanza attiva klopidogrel.
English: This means that Clopidogrel BGR is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Clopidogrel BGR huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Clopidogrel BGR can be given to the following groups of patients:
Maltese: Clopidogrel BGR jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: What are the benefits and risks of Clopidogrel BGR?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Clopidogrel BGR?
English: Why has Clopidogrel BGR been approved?
Maltese: Għaliex ġie approvat Clopidogrel BGR?
English: Because Clopidogrel BGR is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Clopidogrel BGR huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: What is Clopidogrel BGR?
Maltese: Kif ġie studjat Clopidogrel BGR?
English: A-1121 Vienna
Maltese: A-1121 Vjenna
English: Pfizer Health AB Mariefredsvägen 37 SE-645 41 Strängnäs Sweden
Maltese: Pfizer Health AB Mariefredsvägen 37 SE-645 41 Strängnäs
English: Date of first authorisation: 8 March 2002 Date of latest renewal: 20 March 2007
Maltese: Data tal-ewwel awtorizzazzjoni: 8 ta' Marzu, 2002 Data tal-aħħar tiġdid: 20 ta' Marzu, 2007
English: Pulmonary Events
Maltese: Avvenimenti pulmonari
English: EU/1/02/203/005 - 1-pack EU/1/02/203/006 - 7-pack EU/1/02/203/007 - 28-pack
Maltese: EU/1/02/203/005 - Pakkett ta' 1 EU/1/02/203/006 - Pakkett ta' 7 EU/1/02/203/007 - Pakkett ta' 28
English: - The active substance is anakinra.
Maltese: - Is-sustanza attiva hi anakinra.
English: CIAS1/NLRP3 encodes for cryopyrin, a component of the inflammasome.
Maltese: CIAS1/NLRP3 jikkodifika għal cryopyrin, komponent tal-inflammasome.
English: Citric acid, anhydrous Sodium chloride Disodium edetate dihydrate Polysorbate 80
Maltese: Sodium chloride Disodium edetate dihydrate Polysorbate 80
English: Cytochrome P450 Substrates
Maltese: Substrati taċ-ċitokromju P450
English: Anakinra is produced by DNA technology using the micro-organism E. coli.
Maltese: Anakinra tiġi magħmula minn teknoloġija tad-DNA bl-użu tal-mikro-organiżmu E. coli.
English: Kineret is eliminated by glomerular filtration and subsequent tubular metabolism.
Maltese: Kineret jiġi eliminat permezz ta' filtrazzjoni mill-glomeruli u metaboliżmu tubulari sussegwenti.
English: Immunogenicity See section 4.8.
Maltese: Ara sezzjoni 4.8.
English: Safety in paediatric RA (JIA) patients
Maltese: Sigurtà f'pazjenti pedjatriċi b'RA (JIA)
English: Kineret 100 mg/0.67 ml injection Anakinra
Maltese: Kineret 100 mg/0.67 mL injezzjoni Anakinra
English: Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI).
Maltese: Anakinra jinnewtralizza l-attività bijoloġika ta' interleukin-1α (IL-1α) u interleukin-1β (IL-1β)
English: In clinical studies of RA, 775 patients treated with daily Kineret doses of 30 mg, 75 mg, 150 mg, 1 mg/kg or 2 mg/kg, there was an increase of 2.4% to 5.3% in total cholesterol levels 2 weeks after start of Kineret treatment, without a dose-response relationship.
Maltese: Fi studji kliniċi ta' RA, 775 pazjent ikkurati b'dożi ta' kuljum ta' Kineret ta' 30 mg, 75 mg, 150 mg, 1 mg/kg jew 2 mg/kg, kien hemm żieda ta' 2.4% sa 5.3% fil-livelli totali tal-kolesterol, ġimagħtejn wara l-bidu tal-kura b'Kineret, mingħajr relazzjoni bejn id-doża u r-rispons.
English: At Week 24, 6 of 12 patients on anakinra were in remission versus 2 of 10 patients on DMARDs.
Maltese: F'Ġimgħa 24, 6 minn 12-il pazjent fuq anakinra kienu f'remissjoni kontra 2 minn 10 pazjenti fuq DMARDs.
English: For more information on neutropenia see section 4.8.
Maltese: Għal aktar informazzjoni dwar in-newtropenja ara sezzjoni 4.8.
English: Hepatic Events
Maltese: Avvenimenti epatiċi
English: Kineret contains sodium
Maltese: Kineret fih sodium
English: A total of 752 RA patients ≥ 65 years of age, including 163 patients ≥ 75 years of age, were studied in clinical trials.
Maltese: Total ta' 752 pazjent b'RA li kellhom 65 sena, fosthom 163 pazjent li kellhom ≥ 75 sena, ġew studjati waqt studji kliniċi.