FrancophonIA/ELRC3.0 huggingface dataset:
English: Insuman Comb 30 (a biphasic isophane insulin suspension with 30% dissolved insulin) is an insulin with gradual onset and long duration of action.
Maltese: Insuman Comb 30 (suspensjoni ta' l-insulina isophane f'żewġ fażijiet bi 30% ta' insulina maħlula) hija insulina li tibda taħdem bilmod u ddum taħdem għal żmien twil.
English: 9 pens of 3 ml
Maltese: 9 skartoċċi ta' 3 ml
English: Insuman Basal is supplied in pre-filled pens, SoloStar, containing 3 ml suspension (300 IU).
Maltese: Insuman Basal huwa fornut f'pinen mimlija għal-lest, SoloStar, li fiha 3 ml ta' suspensjoni (300
English: Insuman Rapid SoloStar 100 IU/ml in a pre-filled pen Insuman Rapid SoloStar 100 IU/ml in pre-filled pen is only suitable for subcutaneous injections.
Maltese: Insuman Rapid 100 UI/ml fi skartoċċ jew Insuman Rapid SoloStar 100 UI/ml f'pinna mimlija għal-lest m'għandux jitħallat ma' ebda tip ieħor ta' insulina jew ma' analogi tal-insulina.
English: 6 pens of 3 ml
Maltese: 6 skartoċċi ta' 3 ml
English: Insuman Comb 25 SoloStar 100 IU/ml suspension for injection
Maltese: Insuman Comb 25 SoloStar 100 IU/ml suspensjoni għall-injezzjoni.
English: Insuman Comb 30 100 IU/ml suspension for injection in a cartridge
Maltese: Insuman Comb 30 100 IU/ml suspensjoni għall-injezzjoni f'skartoċċ
English: Insuman Implantable must only be used in the Medtronic MiniMed pump which is implanted under the skin of your belly and infuses your insulin continuously.
Maltese: Insuman Implantable għandha tintuża biss fil-pompa Medtronic MiniMed li tiġi impjantata taħt ilġilda ta' żaqqek u tinfuża l-insulina tiegħek b'mod kontinwu.
English: Anti-insulin antibodies
Maltese: - l-antibijotiċi sulfonamidi.
English: The catheter is flushed by using 5-10 ml of sterile rinse buffer solution.
Maltese: Il-kateter jitlaħlaħ bl-użu ta' 5-10 ml ta' soluzzjoni buffer sterili għat-tlaħliħ.
English: Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
Maltese: L-imblokkaturi tar-riċetturi beta, clonidine, lithium salts, jew l-alkoħol jistgħu jżiedu jew inaqqsu l effett ta' l-insulina fuq it-tnaqqis fil-livell tal-glucose fid-demm.
English: Perform a safety test
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: London, 26 September 2008 EMEA/402698/2008
Maltese: Londra, 26 ta' Settembru 2008 EMEA/402698/2008
English: EMEA/402698/2008-EN
Maltese: EMEA/402698/2008-MT
English: Article 35 of Directive 2001/82/EC, as amended
Maltese: Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata.
English: Marketing Authorisations for veterinary medicinal products containing toltrazuril and intended for use in poultry species were previously granted to Bayer HealthCare and/or Ceva Santé Animale in Austria, Belgium, Bulgaria, Cyprus, Czech republic, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, the Netherlands and the United Kingdom following national marketing authorisation procedures.
Maltese: L-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għal prodotti mediċinali veterinarji li fihom toltrazuril u li huma maħsubin sabiex jintużaw fi speċi tat-tjur ingħataw preċedentement lil Bayer HealthCare u/jew lil Ceva Santé Animale fl-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, Franza, ilĠermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakja, isSlovenja, l-Olanda u r-Renju Unit wara proċeduri nazzjonali ta' awtorizzazzjoni għat-tqegħid fis-suq.
English: The Rapporteur and Co-Rapporteur appointed were Mrs R. Kearsley and Mr G. J. Schefferlie respectively.
Maltese: Ir-Relatur u l-KoRelatur maħturin kienu s-Sinjura R. Kearsley u s-Sur G. J. Schefferlie rispettivament.
English: On 31 August 2007 a Community referral under Article 35 of Directive 2001/82/EC, as amended, was initiated by Germany for the nationally authorised product Baycox 2.5 % (solution for poultry).
Maltese: Fil-31 ta' Awwissu 2007, inbeda riferiment Komunitarju skont l-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata, mill-Ġermanja għall-prodott awtorizzat fuq livell nazzjonali, Baycox 2.5% (soluzzjoni għat-tjur).
English: During its July 2008 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion concluding that the assessment of the risk presented by toltrazuril and its major metabolite, toltrazuril sulfone, to terrestrial plants and to groundwater demonstrated that use of products containing toltrazuril is acceptable.
Maltese: Matul il-laqgħa tiegħu ta' Lulju 2008, is-CVMP, fid-dawl tad-data ġenerali sottomessa u taddiskussjoni xjentifika fi ħdan il-Kumitat, adotta opinjoni b'kunsens li tikkonkludi li l-valutazzjoni tarriskji ppreżentati minn toltrazuril u l-metabolit maġġuri tiegħu, toltrazuril sulfone, għal pjanti terrestri u għall-ilma ta' taħt l-art uriet li l-użu ta' prodotti li fihom toltrazuril huwa aċċettabbli.
English: The arbitration procedure started on 11 October 2007 with the adoption of a list of questions to be put to the Marketing Authorisation Holders.
Maltese: Il-proċedura ta' arbitraġġ bdiet fil-11 ta' Ottubru 2007 bl-adozzjoni ta' lista ta' mistoqsijiet li għandhom jiġu mistoqsijin lid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR ALL AUTHORISED VETERINARY MEDICINAL PRODUCTS CONTAINING TOLTRAZURIL INTENDED FOR USE IN POULTRY SPECIES International Non-Proprietary Name (INN): Toltrazuril
Maltese: OPINJONI WARA RIFERIMENT TAĦT L-ARTIKOLU 351 GĦALL-PRODOTTI MEDIĊINALI
English: The recommended dose and duration of treatment for chickens and turkeys is 7 mg/kg bodyweight per day for two consecutive days.
Maltese: Id-doża rakkomandata u t-tul tal-kura għal tiġieġ u dundjani hija 7 mg/kg piż tal-ġisem kuljum għal jumejn konsekuttivi.
English: During its 11-13 December 2007 meeting, the CVMP agreed on a two month extension to the date for submission of responses to the list of questions following a request from Bayer HealthCare.
Maltese: Matul il-laqgħa tiegħu tal-11-13 ta' Diċembru 2007, is-CVMP qabel fuq estensjoni ta' xahrejn għaddata għas-sottomissjoni tat-tweġibiet għal-lista ta' mistoqsijiet fuq talba ta' Bayer HealthCare.
English: • An extended risk assessment on the basis of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines fully and clearly demonstrated that veterinary medicinal products containing toltrazuril and intended for use in poultry species must be expected to have impact on the environment.
Maltese: • Valutazzjoni tar-riskji estiża abbażi tal-linji gwida tal-Kooperazzjoni Internazzjoni dwar lArmonizzazzjoni ta' Rekwiżiti Tekniċi għar-Reġistrazzjoni ta' Prodotti Mediċinali Veterinarji (VICH) uriet b'mod ċar u sħiħ li l-prodotti mediċinali veterinarji li fihom toltrazuril u li huma maħsubin sabiex jintużaw fi speċi ta' tjur huma mistennija li jkollhom impatt fuq l-ambjent.
English: The final opinion was converted into a Decision by the European Commission on 26 September 2008.
Maltese: L-opinjoni finali inqelbet f'Deċiżjoni mill-Kummissjoni Ewropea fis-26 ta' Settembru 2008.
English: However, it was noted that the indications, species and posology in SPCs of some of the authorised products were different and these therefore needed to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Maltese: Madankollu, ġie nnotat li l-indikazzjonijiet, l-ispeċi u l-pożoloġija fl-SPCs ta' uħud mill-prodotti awtorizzati kienu differenti u għaldaqstant, dawn ħtieġu li jiġu emendati sabiex jinġiebu konformi ma' l-indikazzjonijiet u r-reġimi ta' dożaġġ użati fil-valutazzjoni tar-riskji ambjentali.
English: The CVMP concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided that the product is used under the conditions agreed, i.e. a dose of 7 mg/kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Maltese: Is-CVMP ikkonkluda li l-awtorizzazzjonijiet għat-tqegħid fis-suq jistgħu jinżammu mingħajr twissijiet speċjali fil-punt 5.3 (Karatteristiċi ambjentali) tal-SPC diment li l-prodott jintuża skont il-kundizzjonijiet miftehma, jiġifieri, doża ta' 7 mg/kg piż tal-ġisem fuq jumejn konsekuttivi għall-kura ta' kokkidijożi f' tiġieġ u dundjani.
English: Written explanations were provided by the Marketing Authorisation Holders on 18 March 2008.
Maltese: Fit-18 ta' Marzu 2008 ngħataw spjegazzjonijiet bil-miktub lid-Detenturi tal-Awtorizzazzjonijiet għatTqegħid fis-Suq.
English: Germany referred the issue to CVMP due to concerns that toltrazuril may present a potential serious risk to the environment on the following grounds:
Maltese: Il-Ġermanja rreferiet il-kwistjoni lis-CVMP minħabba tħassib li toltrazuril jista' jippreżenta riskju serju potenzjali għall-ambjent għar-raġunijiet li ġejjin:
English: The Marketing Authorisation Holders presented oral explanations to the CVMP on 18 June 2008.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ippreżentaw spjegi bil-fomm lis-CVMP fit-18 ta' Ġunju 2008.
English: On 10 October 2007 the European Commission decided that the scope of the referral should include all authorised veterinary medicinal products containing toltrazuril (i.e. reference product and generics thereof) and intended for use in poultry species.
Maltese: Fl-10 ta' Ottubru 2007, il-Kummissjoni Ewropea ddeċidiet li l-ambitu tar-riferiment għandu jinkludi lprodotti mediċinali veterinarji awtorizzati kollha li fihom toltrazuril (jiġifieri il-prodott ta' riferiment u l-ġeneriċi tiegħu) u maħsubin għall-użu fi speċi ta' tjur.
English: o prevention and control of coccidiosis;
Maltese: KUMITAT GĦALL-PRODOTTI MEDIĊINALI
English: 05 June 2015
Maltese: 5 ta' Ġunju 2015
English: 4.1 Therapeutic indication
Maltese: Indikazzjoni terapewtika
English: • Patients with a build-up of fluids in the lungs (acute pulmonary oedema).
Maltese: • Pazjenti b'akkumulazzjoni ta' fluwidi fil-pulmuni (edima pulmonari akuta).
English: On 26 March 2015, the European Medicines Agency completed a review of Ikorel and Dancor.
Maltese: Fis-26 ta' Marzu 2015, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Ikorel u Dancor.
English: The CHMP also harmonised other sections of the SmPC including sections 4.5 (interactions with other medicinal products), 4.8 (undesirable effects) and 5.1 (pharmacodynamic properties).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħra tal-SmPC, inklużi sezzjonijiet 4.5 (interazzjonijiet ma' prodotti mediċinali oħra), 4.8 (effetti mhux mixtieqa) u 5.1 (proprjetajiet farmakodinamiċi).
English: What are Ikorel and Dancor?
Maltese: X'inhuma Ikorel u Dancor?
English: The companies that market these medicines are Sanofi-Aventis and Merck KGaA.
Maltese: Il-kumpaniji li jqiegħdu dawn il-mediċini fis-suq huma Sanofi-Aventis and Merck KGaA.
English: Ikorel and Dancor are marketed in the following EU Member States: Austria, Denmark, France, Ireland, the Netherlands, Portugal, and the United Kingdom.
Maltese: Ikorel u Dancor huma mqegħdin fis-suq fl-Istati Membri tal-UE li ġejjin: l-Awstrija, id-Danimarka, Franza, l-Irlanda, in-Netherlands, il-Portugall u r-Renju Unit.
English: • Medicines that have a blood pressure-lowering effect.
Maltese: • Mediċini li għandhom effett li jbaxxu l-pressjoni tad-demm.
English: • Patients taking medicines known as ‘phosphodiesterase 5 inhibitors' and/or ‘soluble guanylate cyclase stimulators', since this can lead to a serious drop in blood pressure;
Maltese: • Pazjenti li jkunu qegħdin jieħdu mediċini magħrufa bħala ‘inibituri ta' phosphodiesterase 5' u/jew ‘stimulaturi ta' guanylate cyclase li jinħall', billi dan jista' jwassal għal tnaqqis serju fil-pressjoni tad-demm;
English: Ikorel and Dancor have been authorised in the EU via national procedures.
Maltese: Ikorel u Dancor ġew awtorizzati fl-UE permezz ta' proċeduri nazzjonali.
English: • Patients with shock, severe hypotension (low blood pressure), or heart problems such as ‘left ventricular dysfunction with low filling pressure' or ‘cardiac decompensation';
Maltese: • Pazjenti b'xokk, ipotensjoni (pressjoni tad-demm baxxa) severa, jew problemi fil-qalb bħal ‘disfunzjoni tal-ventrikolu tax-xellug bi pressjoni tal-mili baxxa' jew ‘skumpens tal-qalb';
English: The usual starting dose is 10 mg taken twice a day, preferably in the morning and in the evening.
Maltese: Id-doża tal-bidu tas-soltu hija 10 mg meħudin darbtejn kuljum, preferibbilment filgħodu u filgħaxija.
English: Ikorel and Dancor were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Ikorel u Dancor kienu identifikati li jeħtieġu armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: Why were Ikorel and Dancor reviewed?
Maltese: Għal xiex ġew riveduti Ikorel u Dancor?
English: Gastrointestinal ulcers and ulcers on the skin and some internal (mucosal) surfaces have been reported in patients taking Ikorel or Dancor.
Maltese: Kienu rrappurtati ulċeri gastrointestinali u ulċeri fuq il-ġilda u xi superfiċji interni (tal-mukuża) f'pazjenti li kienu qegħdin jieħdu Ikorel jew Dancor.
English: Ikorel and Dancor are medicines used to treat symptoms of angina pectoris (pain in the chest due to problems with the blood flow to the heart) in adult patients for whom treatment with medicines known as beta-blockers and/or calcium antagonists is not sufficiently effective, not indicated or not tolerated.
Maltese: Ikorel u Dancor huma mediċini użati għall-kura tas-sintomi ta' anġina pectoris (uġigħ fis-sider minħabba problemi fil-fluss tad-demm lejn il-qalb) f'pazjenti adulti li għalihom il-kura b'mediċini magħrufa bħala imblokkaturi beta u/jew antagonisti tal-kalċju ma tkunx effettiva biżżejjed, ma tkunx indikata jew ma tkunx ittollerata.
English: On 12 December 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Ikorel and Dancor in the EU.
Maltese: Fit-12 ta' Diċembru 2013, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Ikorel u Dancor fl-UE.
English: If ulcers develop, Ikorel or Dancor should be permanently discontinued.
Maltese: Jekk jiżviluppaw ulċeri, Ikorel jew Dancor għandhom jitwaqqfu b'mod permanenti.
English: Additionally, Ikorel and Dancor should be used with caution in patients lacking an enzyme called glucose-6-phosphate dehydrogenase, and in patients with heart failure class III or IV (heart disease that severely limits or makes physical activity not possible without discomfort).
Maltese: Barra minn hekk, Ikorel u Dancor għandhom jintużaw b'kawtela f'pazjenti li ma jkollhomx enzima msejħa glucose-6-phosphate dehydrogenase, u f'pazjenti b'insuffiċjenza tal-qalb tal-klassi III jew IV (marda tal-qalb li tillimita severament jew tagħmel l-attività fiżika mhux possibbli mingħajr skomdu).
English: Depending on the patient's response and tolerance to treatment, the dose can be increased up to a maximum of 40 mg twice a day.
Maltese: Skont ir-rispons u t-tolleranza tal-pazjent għall-kura, id-doża tista' tiżdied sa massimu ta' 40 mg darbtejn kuljum.
English: • Medicines that could increase the levels of potassium in the blood, especially in patients with reduced kidney function;
Maltese: • Mediċini li jistgħu jżidu l-livelli tal-potassju fid-demm, speċjalment f'pazjenti b'funzjoni mnaqqsa tal-kliewi;
English: • Aspirin or medicines called NSAIDs (non-steroid anti-inflammatory drugs), because these patients are at higher risk of developing complications of ulcers, such as bleeding in the stomach or gut;
Maltese: • Aspirina jew mediċini msejħa NSAIDs (mediċini antiinfjammatorji nonsterojdali), minħabba li dawn il-pazjenti għandhom riskju akbar li jiżviluppaw kumplikazzjonijiet tal-ulċeri, bħal fsada fl-istonku jew fl-imsaren;
English: Ikorel and Dancor should no longer be used to prevent heart problems, such as a heart attack, in patients with stable coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle), because the available clinical data do not support this indication.
Maltese: Ikorel u Dancor m'għandhomx jintużaw aktar għall-prevenzjoni ta' problemi fil-qalb, bħal attakk talqalb, f'pazjenti b'mard tal-qalb koronarju stabbli (mard tal-qalb ikkawżat mis-sadd tal-vini u l-arterji li jfornu lill-muskolu tal-qalb), minħabba li d-data klinika disponibbli ma tappoġġjax din l-indikazzjoni.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-data sottomessa u d-diskussjoni xjentifika fil-Kumitat, kien tal-opinjoni li lSmPCs, it-tikkettar u l-fuljetti ta' tagħrif għandhom jiġu armoniazzti fl-UE kollha.
English: • Patients with known hypersensitivity (allergy) to nicorandil or to any of the other ingredients;
Maltese: • Pazjenti b'sensittività eċċessiva (allerġija) magħrufa għal nicorandil jew għal kwalunkwe waħda mis-sustanzi l-oħra;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for these medicines in the European Union (EU).
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm bżonn li tiġi armonizzata l-informazzjoni ta' preskrizzjoni għal dawn il-mediċini fl-Unjoni Ewropea (UE).
English: Ikorel and Dancor contain the active substance nicorandil, which works by relaxing the muscles in the walls of the blood vessels that supply the heart, thereby improving blood flow to the heart muscle and relieving the symptoms of angina.
Maltese: Ikorel u Dancor fihom is-sustanza attiva nicorandil, li taħdem billi tirrilassa l-muskoli fil-ħitan tal-vini u l-arterji li jfornu lill-qalb, u b'hekk ittejjeb il-fluss tad-demm lejn il-muskolu tal-qalb u ttaffi s-sintomi tal-anġina.
English: • Patients suffering from hypovolaemia (low blood volume);
Maltese: • Pazjenti li jkunu qegħdin isofru minn ipovolimja (volum baxx tad-demm);
English: Iron (III) oxide (E 172) Titanium dioxide (E 171) Gelatin
Maltese: Iron (III) oxide (E 172) Titanium dioxide (E 171) Ġelatina
English: Africans
Maltese: Afrikani
English: EU/1/18/1325/001 - 004
Maltese: EU/1/18/1325/001 EU/1/18/1325/002 EU/1/18/1325/003 EU/1/18/1325/004
English: Up to 10%
Maltese: Sa 10%
English: • Sinus node dysfunction (including sinus rate < 50 bpm)
Maltese: • Disfunzjoni tas-sinus node (inkluż rata tas-sinus < 50 bpm)
English: Mexiletine Placebo
Maltese: Mexiletine Plaċebo
English: Severe systemic manifestations are responsible for a 10% mortality rate.
Maltese: Manifestazzjonijiet sistemiċi severi huma responsabbli għal rata ta' mortalità ta' 10%.
English: Up to 5%
Maltese: Sa 5%
English: Intermediate metabolisers (IM)
Maltese: Metabolizzaturi intermedji (IM)
English: More than 50% Up to 2%
Maltese: Aktar minn 50% Sa 2%
English: 30 hard capsules 50 hard capsules 100 hard capsules 200 hard capsules
Maltese: 30 kapsula iebsa 50 kapsula iebsa 100 kapsula iebsa 200 kapsula iebsa
English: • Educational guide for HCPs;
Maltese: • Gwida edukattiva għall-HCPs;
English: Caffeine
Maltese: Kaffeina
English: OCT2 substrates
Maltese: Substrati ta' OCT2
English: Lupin Healthcare (UK) Ltd The Urban Building, second floor, 3-9 Albert Street SL1 2BE Slough, Berkshire, United Kingdom
Maltese: Lupin Healthcare (UK) Ltd The Urban Building, it-tieni sular, 3-9 Albert Street SL1 2BE Slough, Berkshire, ir-Renju Unit
English: Date of first authorisation: 18.12.2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18.12.2018
English: Poor metabolisers (PM)
Maltese: Metabolizzaturi batuti (PM)
English: Substrates of other enzymes and transporters
Maltese: Substrati ta' enzimi u trasportaturi oħra
English: Ultra-rapid metabolisers(UM)
Maltese: Metabolizzaturi rapidi ħafna (UM)
English: • Myocardial infarction (acute or past), or abnormal Q-waves
Maltese: • Infart mijokardijaku (akut jew fil-passat), jew Q-waves anormali
English: Mean (SD) absolute change from baseline Effect of treatment (Wilcoxon signed-rank test)
Maltese: L-effett tat-trattament (Wilcoxon signed-rank test)
English: Each hard capsule contains: - mexiletine hydrochloride corresponding to 166.62 mg of mexiletine (active substance) - Other ingredients (maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, iron oxide [E 172], titanium dioxide [E 171]).
Maltese: 62 mg ta' mexiletine (sustanza attiva) - Ingredjenti oħra (maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, iron oxide [E 172], titanium dioxide [E 171]).
English: Primary Analysis
Maltese: Analiżi Primarja
English: Incidence of DRESS has been reported between 1:100 and 1:10.000 patients treated.
Maltese: L-inċidenza ta' DRESS ġiet irrappurtata bħala bejn 1:100 u 1:10.000 pazjenti ttrattati.
English: • Hypersensitivity to any local anaesthetic
Maltese: • Sensittività eċċessiva għal kwalunkwe anestetiku lokali
English: Not known: hallucinations, confusional state Nervous system disorders
Maltese: Mhux magħruf: alluċinazzjonijiet, stat ta' konfużjoni Disturbi fis-sistema nervuża
English: The metabolic degradation proceeds via various pathways, including aromatic and aliphatic hydroxylation, dealkylation, deamination and N-oxidation.
Maltese: Id-degradazzjoni metabolika tgħaddi minn diversi passaġġi, inkluż hydroxylation aromatika u alifatika, dealkylation, deamination u ossidazzjoni N.
English: Namuscla is a medicine that contains the active substance mexiletine.
Maltese: Namuscla hu mediċina li fiha s-sustanza attiva mexiletine.
English: Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-kapsuli huma ppakkjati f'folji tal-Aluminju/PVC/PVDC li fihom 30, 50, 100 jew 200 kapsula.
English: Namuscla is available in blister packs containing 30, 50, 100 or 200 capsules.
Maltese: Namuscla huwa disponibbli f'pakketti b'folji li jkun fihom 30, 50, 100 jew 200 kapsula.
English: • Symptomatic coronary artery disease
Maltese: • Mard sintomatiku tal-arterja koronarja
English: • medicines for heart problems (lidocaine, tocainide, propranolol, esmolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem),
Maltese: • mediċini għal problemi tal-qalb (lidocaine, tocainide, propranolol, esmolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem),
English: Common: tachycardia
Maltese: Komuni:takikardija
English: • Heart failure with mid-range (40-49%) and reduced (<40%) ejection fraction
Maltese: • Insuffiċjenza tal-qalb b'porzjon ta' tfigħ 'il barra ta' medda medja (40-49%) u mnaqqas (<40%)
English: Clinical Myotonia Scale - Severity Global Score Number of subjects
Maltese: Skala Klinika ta' Mijotonija - Punteġġ Globali tas-Severità Numru ta' individwi
English: Store below 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: Several medicinal products including anticonvulsants, antibiotics and also mexiletine have been identified as possible causes.
Maltese: Bosta prodotti mediċinali, inkluż antikonvulsanti, antibijotiċi u wkoll mexiletine, ġew identifikati bħala kawżi possibbli.
English: Mexiletine may interact with drugs transported by OCT2 (such as metformin and dofetilide).
Maltese: Mexiletine jista' jinteraġixxi ma' mediċini trasportati minn OCT2 (bħal metformin u dofetilide).
English: Stiffness score (VAS) (mm) Number of subjects
Maltese: Punteġġ tal-ebusija (VAS) (mm) Numru ta' individwi
English: Not known: atrioventricular block
Maltese: Mhux magħruf: imblokk atrijoventrikulari
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: Reazzjoni tal-mediċina b'eosinofilija u sintomi sistemiċi (DRESS, Drug reaction with eosinophilia and systemic symptoms)