FrancophonIA/ELRC3.0 huggingface dataset:
English: When mogamulizumab has been administered to patients with T-cell lymphomas other than MF or SS, serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in less than 1% of patients during clinical trials, and also reported during the post-marketing period; some of these cases were reported with fatal outcomes.
Maltese: Meta mogamulizumab ingħata lil pazjenti b'linfomi taċ-ċelluli-T minbarra MF jew SS, reazzjonijiet serji tal-ġilda, inkluż is-sindrome ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN), kienu rrapportati f'inqas minn 1% tal-pazjenti matul provi kliniċi, u kienu rrapportati wkoll matul il perjodu ta' wara l-awtorizzazzjoni; uħud minn dawn il-każijiet irrapportati kellhom eżitu fatali.
English: • In the event of a rash (drug related) with severity of Grade 2 or 3 (moderate or severe), treatment with mogamulizumab must be interrupted and the rash should be treated appropriately until rash improves to Grade 1 or less (mild severity), at which time mogamulizumab treatment may be resumed.
Maltese: • F'każ ta' raxx (relatat mal-mediċina) b'severità ta' Grad 2 jew 3 (moderata jew severa), il-kura bi mogamulizumab għandha tiġi interrotta u r-raxx għandu jiġi trattat kif xieraq sakemm ir-raxx jitjieb għal Grad 1 jew inqas (severità ħafifa), u mbagħad il-kura bi mogamulizumab tista' terġa'
English: The effect of hepatic impairment on the clearance of mogamulizumab was evaluated by a population PK analysis in patients with mild hepatic impairment (total bilirubin [TB] less than or equal to the upper limit of normal [ULN] and AST greater than ULN or TB less than 1 to 1.5 times ULN and any AST; n= 80) or moderate (TB greater than 1.5 to 3 times ULN and any AST; n=3) hepatic impairment.
Maltese: L-effett ta' indeboliment tal-fwied fuq it-tneħħija ta' mogamulizumab ġie vvalutat minn analiżi PK tal-popolazzjoni f'pazjenti b'indeboliment tal-fwied ħafif (bilirubina totali [TB] inqas minn jew daqs il-limitu massimu tan-normal [ULN] u AST akbar mill-ULN jew TB ta' inqas minn darba għal 1.5 darbiet l-ULN u kwalunkwe AST; n= 80) jew moderat (TB ta' aktar minn 1.5 sa 3 darbiet l-ULN u kwalunkwe AST; n=3).
English: The most frequently reported serious adverse reactions were pneumonia, pyrexia, infusion related reaction and cellulitis.
Maltese: L-aktar reazzjonijiet avversi serji li ġew irrapportati b'mod frekwenti kienu pulmonite, deni, reazzjoni relatata mal-infużjoni u ċellulite.
English: Acute infusion-related reactions (IRRs) have been observed in patients treated with mogamulizumab.
Maltese: Reazzjonijiet relatati mal-infużjoni Reazzjonijiet akuti relatati mal-infużjoni (IRRs) kienu osservati f'pazjenti li ngħataw kura bi mogamulizumab.
English: Uncommon Tumour lysis syndrome
Maltese: Mhux komuni Sindrome tal-lisi tat-tumur
English: Based on a population PK analysis, the steady-state concentrations of mogamulizumab were reached after 12 weeks of repeated dosing when administered using the recommended regimen, and systemic accumulation was 1.7-fold.
Maltese: Fuq il-bażi ta' analiżi PK tal-popolazzjoni, il-konċentrazzjonijiet fi stat-fiss ta' mogamulizumab intlaħqu wara 12il ġimgħa ta' għoti ta' dożi ripetuti meta ntuża r-reġimen rakkomandat, u l-akkumulazzjoni sistemika kienet ta' 1.7-darbiet.
English: Mogamulizumab infusion was administered at a dose of 1 mg/kg once weekly for the first 28-day cycle (on Days 1, 8, 15 and 22), and on days 1 and 15 of subsequent 28-day cycles.
Maltese: L-infużjoni ta' mogamulizumab ingħatat bħala doża ta' 1 mg/kg darba fil-ġimgħa għall-ewwel ċiklu ta' 28-jum (Fil-Jiem 1, 8, 15 u 22), u fil-jiem 1 u 15 ta' ċikli sussegwenti ta' 28-jum.
English: Mogamulizumab has not been studied in patients with severe hepatic impairment (TB greater than 3 times ULN and any AST).
Maltese: Mogamulizumab ma ġiex studjat fuq pazjenti b'indeboliment tal-fwied sever (TB ta' aktar minn 3 darbiet l-ULN u kwalunkwe AST).
English: CCR4 expression was assessed retrospectively on pretreatment skin biopsies (formalin fixed paraffin embedded) using immunohistochemistry.
Maltese: (ippreservati fil-formalina u inkorporati fil-paraffina) bl-użu ta' immunoistokimika.
English: Mogamulizumab should not be infused concomitantly in the same intravenous line with other medicinal products.
Maltese: Mogamulizumab ma għandux jiġi infuż fl-istess ħin ma' prodotti mediċinali oħra flistess linja intravenuża.
English: Patients with stage IB/II disease treated with mogamulizumab had confirmed ORR of 17.6% compared to 8.3% for vorinostat, and compartment level (blood, skin, lymph node) response rates that were higher than those for vorinostat treated patients (Table 3).
Maltese: Il-pazjenti b'marda fi stadju IB/II li ngħataw kura bi mogamulizumab kellhom ORR ikkonfermata ta' 17.6 % meta mqabbel ma' 8.3 % għal vorinostat, u livell ta' kompartiment (demm, ġilda,
English: Tumour lysis syndrome (TLS) has been observed in patients receiving mogamulizumab.
Maltese: Is-sindrome tal-lisi tat-tumur (TLS) ġie osservat f'pazjenti li kienu qed jingħataw mogamulizumab.
English: The safety profile observed in the 90 days following the last dose of mogamulizumab is consistent with the safety profile observed during the study treatment period.
Maltese: Il-profil ta' sigurtà osservat fid-90 jum wara l-aħħar doża ta' mogamulizumab huwa konsistenti malprofil ta' sigurtà osservat matul il-perjodu ta' kura tal-istudju.
English: - signs of infection, which may include a fever, sweats or chills, flu-like symptoms, sore throat or difficulty swallowing, cough, shortness of breath, stomach pain, nausea or vomiting, diarrhoea and feeling very unwell.
Maltese: - sinjali ta' infezzjoni, li jistgħu jinkludu deni, għeriq jew tkexkix ta' bard, sintomi simili għal dawk tal-influwenza, uġigħ fil-griżmejn jew diffikultà biex tibla, sogħla, qtugħ ta' nifs, uġigħ flistonku, dardir jew rimettar, dijarea u tħossok ma tiflaħx ħafna.
English: The IRRs were mostly mild or moderate in severity, although there have been a few reports of severe reactions (Grade 3).
Maltese: L-IRRs kienu l-aktar ta' severità ħafifa jew moderata, għalkemm kien hemm ftit rapporti ta' reazzjonijiet severi (Grad 3).
English: CCR4 is expressed on the surface of some cancer cells including T cell malignancies, such as MF and SS in which CCR4 expression is inherent.
Maltese: bħal MF u SS li fihom l-espressjoni ta' CCR4 hija inerenti.
English: POTELIGEO contains the active substance mogamulizumab, which belongs to a group of medicines called monoclonal antibodies.
Maltese: POTELIGEO fih is-sustanza attiva mogamulizumab, li tagħmel parti minn grupp ta' mediċini msejħa antikorpi monoklonali.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Maltese: Bħal fi każ tal-proteini terapewtiċi kollha, hemm potenzjal għal immunoġeniċità.
English: V= vorinostat
Maltese: Vorinostat
English: • POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) rash (see section 4.4).
Maltese: • POTELIGEO għandu jitwaqqaf b'mod permanenti f'każ ta' raxx ta' periklu għall-ħajja (Grad 4)
English: Hypothyroidism
Maltese: Ipotirojdiżmu
English: After opening
Maltese: OĦRA TAL
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light.
Maltese: Wara t-tħejjija tal-infużjoni L-istabbiltà kimika u fiżika waqt l-użu intweriet għal 24 siegħa f'temperatura tal-kamra (ta' 25ºC)
English: See section 4.2 for dose modification information.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar ilmodifika tad-doża.
English: Of the 320 subjects exposed to mogamulizumab in Study 0761-010, 21 (6.6%), experienced at least one serious adverse drug reaction (SADR) that occurred within 90 days from the date of last study drug administration.
Maltese: Sigurtà wara l-aħħar doża Mit-320 individwu esposti għal mogamulizumab fi Studju 0761-010, 21 (6.6%), esperjenzaw mill inqas reazzjoni avversa serja waħda għall-mediċina (SADR) li seħħet fi żmien 90 jum mid-data talaħħar għoti tal-mediċina.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodju (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħielsa mis-sodju'.
English: Pharmacological activity of mogamulizumab was noted in foetuses as was evident from a decrease in CCR4 expressing lymphocytes.
Maltese: L-attività farmakoloġika ta' mogamulizumab ġiet innotata fil-feti u kienet evidenti minn tnaqqis fil-linfoċiti li jesprimu s-CCR4.
English: Patients were a median age of 64 years at the time of screening (range 25 to 101 years), 49.5% were 65 years or older, and 58.1% were male.
Maltese: 5% kellhom aktar minn 65 sena, u 58.1% kienu rġiel.
English: PFS, months ITT Population IB/II III/IV ITT=intent to treat Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with mogamulizumab in all subsets of the paediatric population in cutaneous T-cell lymphoma (CTCL) (MF and SS are subtypes of CTCL).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'mogamulizumab f'kull sett tal-popolazzjoni pedjatrika f'linfoma taċ-ċelluli-T tal-ġilda (CTCL) (MF u SS huma sottotipi ta' CTCL).
English: For patients who test positive for current/previous hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended for advice concerning appropriate measures against hepatitis B reactivation.
Maltese: Għal pazjenti li jittestjaw pożittivi għal infezzjoni tal-epatite B attwali/preċedenti, hija rakkomandata konsultazzjoni ma' tabib b'għarfien espert fil-kura tal-epatite B għal pariri dwar miżuri xierqa kontra r-riattivazzjoni tal-epatite B.
English: In clinical trial patients with other T-cell lymphomas there have been reports of stress cardiomyopathy (one case) and acute myocardial infarction (one case).
Maltese: F'pazjenti fi provi kliniċi b'linfomi oħra taċċelluli-T kien hemm rapporti ta' kardjomijopatija minn stress (każ wieħed) u infart mijokardijaku akut
English: This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas.
Maltese: Din il-mediċina tintuża għall-kura ta' adulti b'mycosis fungoides u bis-sindrome ta' Sézary, li huma tipi ta' kanċers imsejħa linfomi taċ-ċelluli-T tal-ġilda.
English: The combination of mogamulizumab with systemic immune modulating medicinal products or with other licensed therapies for MF or SS has not been studied and is, therefore, not recommended, especially in consideration of the risk of severe infections in patients treated with mogamulizumab.
Maltese: Il-kombinazzjoni ta' mogamulizumab ma' prodotti mediċinali li jimmodulaw l-immunità sistemika jew ma' terapiji liċenzjati oħra għal MF jew għal SS ma ġietx studjata u għalhekk mhijiex rakkomandata, speċjalment meta wieħed iqis ir-riskju ta' infezzjonijiet severi f'pazjenti li jingħataw kura b'mogamulizumab.
English: On a power model analysis, no deviation from dose proportionality was evident.
Maltese: F'analiżi ta' mudell tas-saħħa (power model analysis), ma kienx hemm evidenza ta' devjazzjoni mill-proporzjonalità tad-doża.
English: All remaining SOCs reported SADRs in one patient (0.3%).
Maltese: Għall-bqija tas-SOCs, is-SADRs kienu rrapportata f'pazjent wieħed (0.3%).
English: Treatment with mogamulizumab resulted in 8 confirmed complete responses (complete clearing of all affected compartments) compared with 0 patients on vorinostat: 4 of these 8 patients were initially randomized to mogamulizumab and 4 had crossed over to mogamulizumab during the study.
Maltese: Il-kura bi mogamulizumab wasslet għal 8 risponsi kompleti kkonfermati (ikklerjar totali talkompartimenti kollha affettwati) meta mqabbel ma' 0 pazjenti fuq vorinostat: 4 minn dawn it
English: Vomiting
Maltese: Tromboċitopenja
English: The metabolic pathway of mogamulizumab has not been characterised.
Maltese: Il-passaġġ metaboliku ta' mogamulizumab ma ġiex ikkaratterizzat.
English: Table 3: Overall and Compartmental Response Rate in Early Disease Stages
Maltese: Tabella 3: Rata ta' Rispons Globali u Kompartimentali fi Stadji Bikrija tal-Marda
English: Frequency Adverse reaction
Maltese: Progression-Free Survival
English: If SJS/TEN occur, appropriate medical therapy should be administered.
Maltese: F'każ ta' SJS/TEN, għandha tingħata terapija medika xierqa.
English: Subjects with MF or SS treated with mogamulizumab are at increased risk of serious infection and/or viral reactivation.
Maltese: Individwi b'MF jew b'SS li jingħataw kura b'mogamulizumab huma f'riskju akbar ta' infezzjoni serja u/jew ta' riattivazzjoni virali.
English: P-valuea Skin n=186
Maltese: Valur-Pa Linfonodi n=136
English: Symptoms may include skin rashes or blistering, nausea or diarrhoea that doesn't go away, stomach pain or vomiting, joint pain or stiffness, dry or irritated eyes or blurred vision, mouth sores, irritation or pain, a cough that does not go away or difficulty breathing, sensitive genitals, jaundice (turning yellow), dark urine, and any swelling.
Maltese: - uġigħ fil-ġilda, ħakk, infafet, raxx fuq il-ġilda jew ulċeri fil-ħalq, li huma sinjali possibbli li tista' tkun qed tiżviluppa reazzjoni severa tal-ġilda, bħas-sindrome ta' Stevens-Johnson jew nekroliżi epidermali tossika. - uġigħ fis-sider, qtugħ ta' nifs, taħbita tal-qalb mgħaġġla jew bil-mod, għeriq, sturdament, dardir jew rimettar, dgħjufija, tħossok ħażin u tħossok ma tiflaħx.
English: No clinically important differences in the clearance of mogamulizumab were found between patients with mild to severe renal impairment and patients with normal renal function.
Maltese: Ma nstabu l-ebda differenzi klinikament importanti fit-tneħħija ta' mogamulizumab bejn pazjenti b'indeboliment tal-kliewi bejn ħafif sa sever u pazjenti b'funzjoni normali tal-kliewi.
English: Patients with MF or SS are at increased risk of serious infection due to the disruption of dermal integrity caused by cutaneous disease, as well as the immunosuppressive effects of extracutaneous disease, and treatment with mogamulizumab may increase that risk.
Maltese: Pazjenti b'MF jew b'SS huma f'riskju akbar ta' infezzjoni serja minħabba t-tfixkil tal-integrità dermali kkawżata minn mard tal-ġilda, kif ukoll l-effetti immunosoppressivi ta' mard extrakutanju, u l-kura b'mogamulizumab tista' żżid dak ir-riskju.
English: Topical steroids or low doses of systemic corticosteroids may be used during treatment with mogamulizumab; however, the risk of serious infection and/or viral reactivation may be higher in case of concomitant administration with systemic immunosuppressive agents.
Maltese: Jistgħu jintużaw sterojdi topiċi jew dożi baxxi ta' kortikosterojdi sistemiċi waqt il-kura b'mogamulizumab; madankollu, ir-riskju ta' infezzjoni serja u/jew ta' riattivazzjoni virali jista' jkun ogħla fil-każ ta' għoti konkomitanti ma' aġenti immunosoppressivi sistemiċi.
English: There are no clinical data available on the effect of mogamulizumab on human fertility.
Maltese: Fertilità Ma hemm l-ebda data klinika disponibbli dwar l-effett ta' mogamulizumab fuq il-fertilità tal-bniedem.
English: Each arm enrolled 186 patients.
Maltese: F'kull fergħa kien hemm 186 pazjent.
English: Overall, the median period of progression free survival for stage IB/II subjects treated with mogamulizumab was 4.7 months compared to 3.9 months for vorinostat-treated patients (Table 4).
Maltese: il-perjodu medjan ta' sopravivenza mingħajr progressjoni għal individwi b'marda fi stadju IB/II li ngħataw kura b'mogamulizumab kien 4.7 xhur meta mqabbel ma' 3.9 xhur għal pazjenti li ngħataw kura b'vorinostat (Tabella 4).
English: reducing to ≤ 3.8% of subjects after two or more infusions.
Maltese: iseħħ f'4.3% tal-pazjenti.
English: OTHER
Maltese: Fi
English: • Calculate the required volume of POTELIGEO needed to prepare the infusion solution for the 1 mg/kg dosage based on patient weight (see section 4.2).
Maltese: • Ikkalkula l-volum meħtieġ ta' POTELIGEO li teħtieġ biex tipprepara s-soluzzjoni għallinfużjoni għad-doża ta' 1 mg/kg abbażi tal-piż tal-pazjent (ara sezzjoni 4.2).
English: No clinically important differences in the clearance of mogamulizumab were found between patients with mild to moderate hepatic impairment and patients with normal hepatic function.
Maltese: Ma nstabu l-ebda differenzi klinikament importanti fit-tneħħija ta' mogamulizumab bejn pazjenti b'indeboliment tal-fwied bejn ħafif sa moderat u pazjenti b'funzjoni normali tal-fwied.
English: In the mogamulizumab arm, baseline CCR4 expression levels were available in 75% of patients (N=140).
Maltese: Fil-fergħa ta' mogamulizumab, il-livelli tal-espressjoni ta' CCR4 fil-linja bażi kienu disponibbli f'75 % tal-pazjenti
English: 25 September 2013 EMA/592685/2013
Maltese: 25 ta' Settembru 2013 EMA/592685/2013
English: Lancet.
Maltese: Tel.
English: 2013. doi:10.1016/S0140-6736(13)60900-9.
Maltese: Lancet. 2013. doi:10.1016/S0140-6736(13)60900-9.
English: The latter found that, compared with placebo, the risk of major vascular events was increased by about one third by a COX-2 inhibitor (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.312.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032).
Maltese: Tal-aħħar sabet li, meta mqabbla ma' plaċebo, ir-riskju ta' avvenimenti vaskulari maġġuri żdied b'madwar terz b'inibitur ta' COX-2 (proporzjon tar-rata [RR] ta' 1.37, intervall tal-kunfidenza [CI] ta' 95% ta' 1.14-1.66; p=0.0009) jew b'diclofenac (1.41, 1.12-1.78; p=0.0036), prinċipalment minħabba żieda f'avvenimenti koronarji maġġuri (coxibs: 1.76, 1.31-2.37; p=0.0001; diclofenac:
English: Diclofenac is an NSAID.
Maltese: Diclofenac huwa NSAID.
English: Information to healthcare professionals
Maltese: Informazzjoni lill-pazjenti
English: It is currently available in the European Union (EU) in a number of different formulations.
Maltese: Attwalment huwa disponibbli flUnjoni Ewropea (UE) f'għadd ta' formulazzjonijiet differenti.
English: A subgroup of NSAIDs, called ‘selective COX-2 inhibitors' (also known as ‘coxibs'), acts by blocking the COX-2 enzyme rather than both.
Maltese: Sottogrupp ta' NSAIDs, imsejħa ‘inibituri selettivi ta' COX-2' (magħrufa wkoll bħala ‘coxibs'), jaġixxu billi jimblokkaw l-enzima COX-2 minflok it-tnejn li huma.
English: • The PRAC has further reviewed available data including several new case-control and cohort studies, a post-hoc analysis of data from the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) programme,1 and a meta-analysis2 by the Coxib and traditional NSAID Trialists Collaboration which involved over 600 clinical trials.
Maltese: • Il-PRAC ulterjorment irreveda dejta disponibbli fosthom bosta studji ġodda tal-kontroll tal-każ u studji ta' koorti, analiżi post-hoc ta' dejta mill-programm MEDAL1 (Multinational Etoricoxib and Diclofenac Arthritis Long-term) u meta-analiżi2 mill-Coxib and traditional NSAID Trialists Collaboration li kienet tinvolvi aktar minn 600 prova klinika.
English: The review of systemic diclofenac was initiated on 31 October 2012 at the request of the United Kingdom medicines agency, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' diclofenac sistemiku inbdiet fil-31 ta' Ottubru 2012 fuq talba tal-aġenzija tal-mediċini tar-Renju Unit, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: New safety advice for diclofenac
Maltese: Pariri ġodda dwar is-sigurtà għal diclofenac
English: Traditional NSAIDs act by blocking the effects of the two cyclo-oxygenase (COX) enzymes, known as COX-1 and COX-2, resulting in a reduced production of substances called prostaglandins.
Maltese: NSAIDs tradizzjonali jaġixxu billi jimblokkaw l-effetti taż-żewġ enzimi ċiklooxygenase (COX), magħrufa bħala COX-1 u COX-2, li jwassal għal tnaqqis fil-produzzjoni ta' sustanzi msejħa prostaglandini.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: IsCMDh, korp li jirrappreżenta lill-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards armonizzati tas-sigurtà għal mediċini awtorizzati permezz ta' proċeduri nazzjonali madwar l-UE.
English: It belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs).
Maltese: Jagħmel parti minn grupp ta' mediċini msejħa ‘mediċini antiinfjammatorji mhux sterojdi' (NSAIDs).
English: In addition to diclofenac, widely used NSAIDs also include ibuprofen and naproxen.
Maltese: Minbarra diclofenac, NSAIDs li jintużaw b'mod wiesgħa jinkludu wkoll ibuprofen u naproxen.
English: Cardiovasc Ther.
Maltese: Aktar dwar il-mediċina
English: • Use of diclofenac is contra-indicated in patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.
Maltese: • L-użu ta' diclofenac huwa kontra-indikat f'pazjenti b'insuffiċjenza konġestiva stabbilita tal-qalb (NYHA tal-klassi II-IV), mard iskemiku tal-qalb, mard arterjali periferali jew mard ċerebrovaskulari.
English: • Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg daily) and in long-term treatment.
Maltese: • Dejta minn provi kliniċi u dejta epidemjoloġika konsistentement tindika żieda fir-riskju ta' avvenimenti trombotiċi arterjali (pereżempju infart mijokardijaku jew puplesija) assoċjat mal-użu ta' diclofenac, b'mod partikolari f'doża għolja (150 mg kuljum) u f'kura fit-tul.
English: Diclofenac is authorised for the relief of pain and inflammation in a wide range of conditions, including arthritic conditions and acute musculoskeletal disorders.
Maltese: Diclofenac huwa awtorizzat għas-serħan mill-uġigħ u l-infjammazzjoni f'firxa wiesa ta' kundizzjonijiet, fosthom kondizzjonijiet tal-artrite u disturbi muskuloskeletali akuti.
English: New measures aim to minimise cardiovascular risks
Maltese: Miżuri ġodda bil-għan li jiġu minimizzati r-riskji kardjovaskulari
English: Diclofenac is effective in reducing inflammation and pain.
Maltese: Diclofenac huwa effettiv fit-tnaqqis tal-infjammazzjoni u l-uġigħ.
English: The PRAC review of diclofenac was started at the request of the UK medicines regulatory agency, the MHRA, in October 2012 in response to findings from the 2012 review of NSAIDs.
Maltese: Ir-reviżjoni tal-PRAC ta' diclofenac inbdiet fuq talba tal-aġenzija regolatorja tal-mediċini tar-Renju Unit, l-MHRA, f'Ottubru 2012 bi tweġiba għas-sejbiet mir-reviżjoni tal-NSAIDs tal-2012.
English: However, considering that the cardiovascular risk with systemic diclofenac appears similar to that of selective COX-2 inhibitors, it was considered that any risk minimisation in place for COX-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac.
Maltese: Madankollu, meta wieħed iqis li rriskju kardjovaskulari b'diclofenac sistemiku jidher simili għal dak ta' inibituri selettivi ta' COX-2, kien ikkunsidrat li kwalunkwe minimizzazzjoni tar-riskju fis-seħħ għal inibituri ta' COX-2 fir-rigward tarriskju kardjovaskulari għandha tapplika wkoll għal diclofenac.