FrancophonIA/ELRC3.0 huggingface dataset:
English: In one study (n = 157), which used a 6mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63).
Maltese: Fi studju wieħed (n = 157), fejn intużat doża fissa ta' 6 mg ta' pegfilgrastim id-dewmien medju ta' newtropenija ta' grad 4 għall-grupp b'pegfilgrastim kien ta' 1.8 ijiem meta mqabbel ma' 1.6 ijiem tal-grupp b'filgrastim (differenza ta' 0.23 jum, 95% CI0.15, 0.63). Matul l-istudju kollu, ir-rata ta' newtropenija bid-deni kienet ta' 13% tal-pazjenti kkurati b'pegfilgrastim mqabbla ma' 20% tal-pazjenti kkurati b'filgrastim (differenza ta' 7%, 95% CI ta'19%, 5%).
English: Ristempa contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol (23 mg) sodium għal kull 6 mg doża, ie essenzjalment mingħajr sodium.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 yrs (75%) compared to older children aged 6-11 years and 12-21 years (70% and 33%, respectively) and adults (see sections 4.8 and 5.2).
Maltese: Barra dan kienet osservata inċidenza ogħla ta' newtropenija bid-deni fi tfal iżgħar b'età ta' 0-5 snin (75%) meta mqabbel ma' tfal akbar b'età ta' 6-11-il sena u 12-21 sena (70% u 33%, rispettivament) u ma' adulti (ara sezzjonijiet 4.8 u
English: Common cases of thrombocytopenia have been reported.
Maltese: Prodott mediċinali jingħata bir-riċetta tat-tabib.
English: The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-imnaġġar tal-prodott mediċinali qabel l-amminisstrazzjoni, ara sezzjoni 6.6.
English: Single doses of 300 µg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Maltese: Dożi singoli ta' 300 μg/kg ġew amministrati taħt il-ġilda lil numru limitat ta' voluntiera b'saħħithom u pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun mingħajr effetti avversi serji.
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Maltese: Il-fattur uman li jistimola l-kolonji ta' granuloċiti (G-CSF) huwa glikoproteina li tirregola ilproduzzjoni u l-ħelsien ta' newtrofili mill-mudullun.
English: The most common adverse reaction reported was bone pain (see section 5.1 and 5.2).
Maltese: L-aktar reazzjoni avversa rrappurtata b'mod komuni kienet uġigħ flgħadam (ara sezzjoni 5.1 u 5.2).
English: In animal models concomitant administration of Ristempa and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Maltese: Fi studji fuq lannimali, l-għoti ta' Ristempa ma' 5-fluorouracil (5- FU) jew anti-metaboliti oħra wriet żjieda filmajelosoppressjoni.
English: Remember
Maltese: Ara
English: • serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty
Maltese: • reazzjonijiet allerġiċi serji, inkluż anafilassi (debbulizza, pressjoni titbaxxa, tbatija biex tieħu n
English: This medicinal product contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially ‘sodium-free'
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol (23 mg) sodium għal kull 6 mg ma, ie huwa essenzjalment mingħajr sodium.
English: Amgen Europe BV Minervum 7061
Maltese: Amgen Europe BV Minervum 7061 NL-4817 ZK Breda L-Olanda
English: This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults.
Maltese: Din ir-reazzjoni avversa kienet identifikata permezz ta' sorveljanza ta' wara t-tqegħid fis-suq iżda ma kienetx osservatia fi provi kliniċi randomised ukkontrollati f'adulti.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-kartuna u fuq it-tikketta tas-siringa (wara EXP).
English: Women who become pregnant during Ristempa treatment are encouraged to enrol in Amgen's Pregnancy Surveillance Programme.
Maltese: Rappurtar suspettati reazzjonijiet avversi wara l-awtorizzazzjoni tal-prodott mediċinali huwa importanti.
English: Thrombocytopenia1 Leukocytosis
Maltese: Anemija taċ-ċellula b'forma ta' minġel
English: Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Maltese: Intwera li pegfilgrastim u filgrastim għandhom mekkaniżmu ta' azzjoni identiku, u jikkawżaw żjieda sinifikanti fl-għadd ta' newtrofili fid-demm periferali fi żmien 24 siegħa, b'żjidiet minuri fil-monoċiti u/jew fil-limfoċiti.
English: After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained during the period of neutropenia after myelosuppressive chemotherapy.
Maltese: Wara doża waħda ta' pegfilgrastim taħt il-ġilda, l-ogħla konċentrazzjoni fis-serum ta' pegfilgrastim tintlaħaq minn 16 sa 120 siegħa wara d-dożaġġ u l-konċentrazzjonijiet fis-serum ta' pegfilgrastim jinżammu tul il-perijodu ta' newtropenija wara kimoterapija majelosoppressiva.
English: See section “Description of selected adverse reactions” below.
Maltese: 1 Ara sezzjoni “Deskrizzjoni ta' xi reazzjonijiet avversi magħżula” ta' taħt.
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti kienu uġigħ fl-għadam (komuni ħafna [≥ 1/10]) u uġigħ muskolu-skeletrali (komuni).
English: The safety and efficacy of Ristempa have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Maltese: Is-sigurtà u l-effikaċja ta' Ristempa ma ġewx investigati f'pazjenti b'sindrome majelodisplastika, lewkimja majeloġenika kronika, u f'pazjenti b'Lewkimja Majelojde Akuta (AML) sekondarja; għalhekk, Ristempa m'għandux jintuża f'pazjenti bħal dawn.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim* f'0.6 ml ta' soluzzjoni għall-injezzjoni.
English: Back- Ristempa reference guide:
Maltese: Instruzjonijiet għall-użu:
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
Maltese: Il-fattur li jistimola l-kolonji ta' granuloċiti jista' jippromwovi it-tkabbir ta' ċelluli majelojdi in vitro u effetti simili jistgħu jiġu osservati f'xi ċelluli mhux majelojdi in vitro.
English: UNBLISTERED SYRINGE LABEL
Maltese: Vaskulite fil-ġilda
English: • general aches and pains in the joints and muscles.
Maltese: • uġigħ ġenerali u uġigħ fil -ġogi u fil-muskoli .
English: • think you may be pregnant; or
Maltese: • taħseb li inti tqila; jew
English: How do I prepare my Ristempa injection?
Maltese: Kif nipprepara l-injezzjoni ta' Ristempa?
English: Ristempa may be exposed to room temperature (not above 30C) for a maximum single period of up to 72 hours.
Maltese: Ristempa jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 30°C) għal perijodu wieħed ta' massimu ta' 72 siegħa.
English: Profile of Median Pegfilgrastim Serum Concentration and Absolute Neutrophil Count (ANC) in Chemotherapy Treated Patients after a Single 6 mg Injection
Maltese: Profil tal-Konċentrazzjoni Medjana fis-Serum ta' Pegfilgrastim u l-Għadd Assolut ta' Newtrofili (ANC) f'Pazjenti Kkurati b'Kimoterapija wara
English: Splenomegaly and splenic rupture
Maltese: Disturbi taddemm u tassistema limfatika
English: Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Maltese: Bħal fil-każ ta' filgrastim, in-newtrofili li jiġu prodotti b'rispons għal pegfilgrastim juru funzjonijiet normali jew miżjuda kif intwera f'testijiet dwar il-funzjoni kimotattika u fagoċitika.
English: Do not use the pre-filled syringe if:
Maltese: Sustanzi mhux attivi li għandhom azzjoni magħrufa:
English: Grab here
Maltese: Jekk ikun
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section
Maltese: B'mod mhux komuni, każijiet irriżultaw f'insuffiċjenza respiratorja jew Sindrome ta' Distress Respiratorju Akut (ARDS), li jistgħu jkunu fatali (ara sezzjoni 4.4).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA' L-AWTORIZZAZZJONI TAL-MANIFATTURI RESPONSABBLI
English: The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section
Maltese: It-tap tal-labra tas-siringa mimlija għal-lest fih lastiku naturali niexef (mnissel mill-latex) (ara sezzjoni
English: Sickle cell crisis2; Splenomegaly Splenic rupture2
Maltese: Kriżi taċ-ċellula forma ta' minġel Tkabbir tal-milsa2 Milza mifqugħha
English: Do not use Ristempa
Maltese: Rimi ta' siringi użati
English: • soft-tissue sarcoma.
Maltese: • sarkoma tat-tessut artab.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 27 May 2015.
Maltese: Peress li lkumpanija kienet ipprovdiet l-informazzjoni addizzjonali mitluba, iċ-‘ċirkostanzi ta' eċċezzjoni' ntemmew fis-27 ta' Mejju 2015.
English: The full EPAR for Yondelis 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: • ovarian cancer;
Maltese: • kanċer tal-ovarji;
English: Other information about Yondelis
Maltese: Informazzjoni oħra dwar Yondelis
English: Fatal side effects have occurred in 1.9% and 0.9% of patients treated with Yondelis as a single agent and combination therapy, respectively.
Maltese: Effetti sekondarji fatali seħħew f'1.9% u 0.9% tal-pazjenti li ngħataw Yondelis waħdu u bħala terapija kkombinata rispettivament.
English: EPAR summary for the public trabectedin
Maltese: Sommarju tal-EPAR għall-pubbliku trabestedin
English: Yondelis is used in combination with pegylated liposomal doxorubicin (PLD, another cancer medicine).
Maltese: Yondelis jintuża flimkien ma' liposomal doksorubicin pegilat (PLD, mediċina oħra kontra lkanċer).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Yondelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Yondelis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Yondelis.
English: Yondelis is a cancer medicine that contains the active substance trabectedin.
Maltese: Yondelis huwa mediċina kontra l-kanċer li fih is-sustanza attiva trabestedin.
English: The most common side effects of any severity were neutropenia (low levels of neutrophils, a type of white blood cell), nausea (feeling sick), vomiting, increase in liver enzymes, anaemia (low red blood cell counts), tiredness, thrombocytopenia (low blood platelet counts), loss of appetite and diarrhoea.
Maltese: L-effetti sekondarji l-aktar komuni ta' kwalunkwe severità huma newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda fid-demm), nawżja (tħossok ma tiflaħx), remettar, żieda fl-enżimi tal-fwied, anemija (għadd baxx ta' ċelloli ħomor fid-demm), għeja, tromboċitopenija (għadd baxx ta' pjastrini fid-demm), telf ta' aptit u dijarrea.
English: The active substance in Yondelis, trabectedin, is a synthetic version of a substance that was originally extracted from a species of tunicate or ‘sea squirt' (a marine animal).
Maltese: Is-sustanza attiva f'Yondelis, it-trabestedin, hija verżjoni sintetika ta' sustanza kimika estratta oriġinarjament minn speċi ta' tunikat jew “sea squirt” (annimal tal-baħar).
English: • ovarian cancer (cancer of the ovaries) that has relapsed (come back after previous treatment) and is sensitive to medicines containing platinum.
Maltese: • kanċer tal-ovarji reċidiv (jerġa' jitfaċċa wara kura preċedenti) u sensittiv għal mediċini li fihom ilplatinu.
English: Because the numbers of patients with soft-tissue sarcoma and ovarian cancer are low, the diseases are considered ‘rare', and Yondelis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 May 2001 (for soft-tissue sarcoma) and on 17 October 2003 (for ovarian cancer).
Maltese: Minħabba li n-numru ta' pazjenti morda bis-sarkoma tat-tessut artab u l-kanċer tal-ovarji huwa wieħed baxx, dan il-mard huwa kkunsidrat bħala “rari”, u Yondelis ġie kklassifikat bħala “mediċina orfni” (mediċina użata fil-mard rari) fit-30 ta' Mejju 2001 (għas-sarkoma tat-tessut artab) u fis-17 ta' Ottubru 2003 (għal kanċer tal-ovarji).
English: Around 10% of those patients treated with Yondelis as a single agent and 25% treated with Yondelis in combination therapy can be expected to have serious side effects.
Maltese: Madwar 10% ta' dawk il-pazjenti li jingħataw Yondelis waħdu u 25% li jingħataw Yondelis bħala terapija kkombinata jistgħu jistennew li jkollhom effetti sekondarji serji.
English: Why has Yondelis been approved?
Maltese: Għaliex ġie approvat Yondelis?
English: What is Yondelis?
Maltese: X'inhu Yondelis?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis on 17 September 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Yondelis fis-17 ta' Settembru 2007.
English: For soft-tissue sarcoma, Yondelis has been studied in one main study involving 266 patients with liposarcoma (a sarcoma originating in fat cells) or leiomyosarcoma (a sarcoma originating in ‘smooth' or involuntary muscle cells) that was advanced or metastatic (had spread to other parts of the body).
Maltese: Għas-sarkoma tat-tessut artab, Yondelis ġie studjat fi studju ewlieni wieħed li involva 266 pazjent li jbatu minn liposarkoma (sarkoma li toriġina fiċ-ċelloli tax-xaħam) jew lejomjosarkoma (sarkoma li toriġina fiċ-ċelloli tal-muskolu “lixx” jew involontarja) fi stadju avvanzat jew metastatiku (infirex ma' partijiet oħra tal-ġisem).
English: For ovarian cancer, Yondelis in combination with PLD was compared with PLD alone in one main study involving 672 women whose disease had come back or got worse after previous treatment.
Maltese: Għall-kanċer tal-ovarji, Yondelis flimkien ma' PLD tqabbel ma' PLD waħdu fi studju ewlieni wieħed li involva 672 mara li l-marda li kellhom reġgħet feġġet jew aggravat wara kura li kienu diġà ħadu.
English: For the full list of restrictions, see the package leaflet.
Maltese: Għal-lista ta' restrizzjonijiet, ara l-pakkett ta' tagħrif.
English: Yondelis is used to treat adults with two types of cancer:
Maltese: Yondelis jintuża fil-kura ta' adulti b'żewġ tipi ta' kanċer:
English: What is the risk associated with Yondelis?
Maltese: X'inhu r-riskju assoċjat ma' Yondelis?
English: For ovarian cancer, the combination of Yondelis and PLD was more effective than PLD alone: patients receiving the combination treatment lived for an average of 7.3 months without their disease getting worse, compared with 5.8 months in those receiving PLD alone.
Maltese: Għall-kanċer tal-ovarji, il-kombinazzjoni ta' Yondelis u PLD kienet aktar effikaċi minn PLD waħdu: ilpazjenti li ngħataw il-kura ta' kombinazzjoni għexu medja ta' 7.3 xhur mingħajr ma l-marda qalbet għall-agħar, meta mqabbla mal-5.8 xhur f'dawk li ngħataw PLD waħdu.
English: A risk management plan has been developed to ensure that Yondelis is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Yondelis jintuża bl-aktar mod sigur possibbli.
English: Yondelis was originally authorised under ‘exceptional circumstances', because, limited information was available at the time of approval on soft-tissue sarcoma.
Maltese: Yondelis kien oriġinarjament awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni', minħabba li, fiż-żmien talapprovazzjoni dwar is-sarkoma tat-tessut artab, kienet disponibbli informazzjoni limitata.
English: For ovarian cancer, it is given at a dose of 1.1 mg/m2 every three weeks as an infusion lasting three hours, immediately after the PLD infusion.
Maltese: Għall-kanċer tal-ovarji, id-doża għandha tkun ta' 1.1 mg/m2 kull tliet ġimgħat bħala infużjoni li ddum tliet sigħat, immedjatament wara l-infużjoni tal-PLD.
English: Yondelis is used when treatment with anthracyclines and ifosfamide (other cancer medicines) have stopped working, or in patients who cannot be given these medicines;
Maltese: Yondelis jintuża meta l-kura bl-antraċiklini u l-ifosfamidi (mediċini oħra kontra l-kanċer) ma tibqax taħdem, jew f'pazjenti li ma jkunux jistgħu jingħataw dawn il-mediċini;
English: For soft-tissue sarcoma, the recommended dose of Yondelis is 1.5 mg per square metre of body surface area (calculated using the patient's height and weight), given as a single infusion lasting 24 hours every three weeks.
Maltese: Għas-sarkoma tat-tessut artab, id-doża rakkomandata ta' Yondelis hija 1.5 mg għal kull metru kwadru tas-superfiċje tal-ġisem (ikkalkolata skont it-tul u l-piż tal-pazjent), mogħtija f'infużjoni waħda fuq 24 siegħa kull tliet ġimgħat.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal iktar informazzjoni, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Patients receiving it once every three weeks lived for an average of 3.8 months without their disease getting worse, compared with 2.1 months in those receiving Yondelis three times per month.
Maltese: Il-pazjenti li ngħataw il-mediċina darba kull tliet ġimgħat, għexu għal medja ta' 3.8 xhur mingħajr ma aggravatilhom il-marda meta mqabbla ma' 2.1 xahar tal-pazjenti ttrattati b'Yondelis tliet darbiet fix-xahar.
English: The CHMP concluded that Yondelis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Yondelis huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The effect of Yondelis was more pronounced in the women whose cancer was sensitive to platinum-containing medicines.
Maltese: Madwar żewġ terzi tal-pazjenti kellhom kanċer li kien sensittiv għal mediċini li jkun fihom il-platinu.
English: Namuscla (mexiletine)
Maltese: Namuscla (meksiletina)
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/EU3141353.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/medicines/human/orphan-designations/EU3141353.
English: The recommended starting dose is 1 capsule a day.
Maltese: Id-doża inizjali rakkomandata hija kapsula 1 kuljum.
English: Further information on Namuscla can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Namuscla.
Maltese: ema.europa.eu/medicines/human/EPAR/Namuscla.
English: Myotonic disorders are rare, and Namuscla was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 November 2014.
Maltese: Disturbi mijotoniċi huma rari, u Namuscla ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fid-19 ta' Novembru 2014.
English: Other information about Namuscla
Maltese: Informazzjoni oħra dwar Namuscla
English: After 18 days of treatment, the average score for patients treated with Namuscla decreased from 66 to 24, while the score for patients given placebo went from 75 to 66.
Maltese: Wara 18-il jum ta' kura, il-punteġġ medju għall-pazjenti kkurati b'Namuscla naqas minn 66 għal 24, filwaqt li l-punteġġ għall-pazjenti li ngħataw il-plaċebo mar minn 75 għal 66.
English: The most serious side effects reported (which may affect up to 1 in 10,000 people) are arrhythmias (disturbances of heart rhythm) and a severe reaction affecting skin, blood and internal organs, known as drug reaction with eosinophilia and systemic symptoms (DRESS).
Maltese: L-effetti sekondarji l-aktar serji rrapportati (li jistgħu jaffettwaw sa persuna 1 minn 10 000) huma arritmiji (disturbi tar-ritmu tal-qalb) u reazzjoni severa li taffettwa l-ġilda, l-organi tad-demm u interni, magħrufa bħala reazzjoni għallmediċina b'eosinofilja u sintomi sistematiċi (DRESS).
English: Namuscla is a medicine used to treat symptoms of myotonia (muscle stiffness) in patients with nondystrophic myotonic disorders, a group of inherited muscle disorders.
Maltese: Namuscla huwa mediċina li tintuża għall-kura ta' sintomi ta' mijotonja (egħbusija tal-muskoli) f'pazjenti li jbatu minn disturbi mijotoniċi mhux distrofiċi, grupp ta' disturbi tal-muskoli li jintirtu.
English: The company that markets Namuscla will provide educational material for doctors and a ‘patient alert card' with important information about the risks associated with the medicine, in particular the risk of arrhythmias.
Maltese: Il-kumpanija li tqiegħed Namuscla fis-suq ser tipprovdi materjal edukattiv għat-tobba u ‘kard tattwissija tal-pazjent' b'informazzjoni importanti dwar ir-riskji assoċjati mal-mediċina, b'mod partikolari r-riskju ta' arritmiji.
English: What are the risks associated with Namuscla?
Maltese: X'inhuma r-riskji assoċjati ma' Namuscla?
English: Namuscla must not be used in patients who are hypersensitive (allergic) to the active substance, mexiletine, to any other ingredients of the medicine, or to local anaesthetics (medicines that block out sensation used to prevent pain in a part of the body).
Maltese: Namuscla m'għandux jintuża f'pazjenti li jkunu sensittivi ħafna (allerġiċi) għas-sustanza attiva, ilmeksiletina, u għal kwalunkwe sustanza oħra tal-mediċina, jew għal anestetiċi lokali (mediċini li jimblokkaw is-sensazzjoni użati għall-prevenzjoni tal-uġigħ f'parti tal-ġisem).
English: Why is Namuscla authorised in the EU?
Maltese: Għaliex Namuscla huwa awtorizzat fl-UE?
English: The active substance in Namuscla, mexiletine, works by blocking channels in muscle cells that allow sodium ions (electrically charged particles) to pass in and out.
Maltese: Is-sustanza attiva f'Namuscla, il-meksiletina, taħdem billi timblokka kanali fiċ-ċelloli tal-muskoli li jippermettu l-joni tas-sodju (partikuli ċċarġjati bl-elettriku) jgħaddu ‘l ġewwa u ‘l barra.
English: The most common side effects with Namuscla (which may affect more than 1 in 10 people) are abdominal (belly) pain and insomnia (difficulty sleeping).
Maltese: L-effetti sekondarji l-aktar komuni b'Namuscla (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma wġiegħ addominali (taż-żaqq) u insomnja (diffikultà fl-irqad).
English: The company also provided supportive data on the effectiveness of Namuscla from the literature.
Maltese: Aktar informazzjoni dwar Namuscla tinstab fis-sit elettroniku tal-Aġenzija:
English: By blocking them, the medicine helps to reduce the stiffness that occurs when the contractions are prolonged.
Maltese: Meta timblukkahom, il-mediċina tgħin biex titnaqqas l-ebusija li sseħħ meta l-kontrazzjonijiet jittawlu.
English: For the full list of side effects of Namuscla, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Namuscla, ara l-fuljett ta' tagħrif.