FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Wilzin If you are allergic (hypersensitive) to zinc or any of the other ingredients of Wilzin.
Maltese: Tieħux Wilzin Jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal zinc jew sustanza oħra ta' Wilzin.
English: Dose adjustments to guarantee that the foetus will not become copper deficient must be done and close monitoring of the patient is mandatory (see section 4.4).
Maltese: Aġġustamenti fid-doża biex jiżguraw li l-fetu ma jkollux nuqqas ta' copper għandhom jsiġu w monitoraġġ mill-qrib tal-pazjenta huwa obbligatorju (ara sezzjoni 4.4)
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA
English: EXPIRY DATE
Maltese: DATA TA' META JISKADI
English: Wilzin is usually not recommended for initial therapy of patients with signs and symptoms of Wilson's disease because of its slow onset of action.
Maltese: Wilzin ġeneralment mhux rakkomandat bħala terapija inizjali f'pazjenti li għandhom sinjali u sintomi tal-marda ta' Wilson minħabba li jdum biex jibda jaħdem.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I : Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Substances in food, especially phytates and fibres, bind zinc and prevent it from entering the intestinal cells.
Maltese: Sustanzi fl-ikel, speċjalment phytates u fibri, jorbtu zinc u ma jħalluħx jidħol fiċ-ċelloli intestinali.
English: United Kingdom Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414333
Maltese: Tel: +44 (0)1491 414333
English: If you take more Wilzin than prescribed, you may experience nausea, vomiting and dizziness.
Maltese: Jekk tieħu aktar Wilzin milli suppost, jista' jkun li jħossok mqalla, tirremetti jew tistordi.
English: Urinary copper levels are usually increased with chelation therapy such as penicillamine or trientine.
Maltese: Il-livelli ta' copper fl-awrina ġeneralment jogħlew b' terapija kelanti bħal ma hija b'penicillamine jew trientine.
English: 4.1 Therapeutic indications
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Zinc acetate dihydrate is not recommended for the initial therapy of symptomatic patients because of its slow onset of action.
Maltese: Tibdil fit-terapija huwa rakkomandat f'din is-sitwazzjoni.
English: If you take more Wilzin than you should:
Maltese: Jekk tieħu Wilzin aktar milli suppost:
English: Annex IV
Maltese: Anness IV
English: Neurology.
Maltese: Neurol
English: Fatal cases
Maltese: Każijiet fatali
English: 2018 Feb ;90(7): e601-e605
Maltese: Newroloġija. 2018 Frar; 90(7): e601-e605
English: 2017 Feb;16(2):104-106
Maltese: Lancet Neurol. 2017 Frar; 16(2):104-106
English: 3 Willis M et al., An observational study of alemtuzumab following fingolimod for multiple sclerosis.
Maltese: 3 Willis M et al., “An observational study of alemtuzumab following fingolimod for multiple sclerosis” (Studju ta' osservazzjoni tal-alemtuzumab wara t-teħid tal-fingolimod għall-isklerożi multipla).
English: 2 Wehrum et al., Activation of disease during therapy with alemtuzumab in 3 patients with multiple sclerosis.
Maltese: 2 Wehrum et al., “Activation of disease during therapy with alemtuzumab in 3 patients with multiple sclerosis” (Attivazzjoni tal-marda waqt it-terapija b'alemtuzumab fi 3 pazjenti bl-isklerożi multipla).
English: 2017 Jan;4(2): e320
Maltese: Neuroimmunol Neuroinflamm. 2017 Jan;4(2): e320
English: Immune-mediated reactions
Maltese: Reazzjonijiet medjati mis-sistema immunitarja
English: Severe B-cell-mediated CNS disease secondary to alemtuzumab therapy.
Maltese: 1 Haghikia A et al. “Severe B-cell-mediated CNS disease secondary to alemtuzumab therapy” (Marda severa tasCNS medjata taċ-ċellola B sekondarja għal terapija ta' alemtuzumab).
English: Lemtrada (alemtuzumab) is indicated for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Maltese: Lematrada (alemtuzumab) huwa indikat għal pazjenti adulti bl-isklerożi multipla li tirkadi-tbatti (RRMS) b'marda attiva definita b'karatteristiċi kliniċi jew tal-immaġni.
English: These safety concerns are related to:
Maltese: - Każijiet fatali:
English: Cardiovascular (including cerebrovascular) reactions temporally associated with alemtuzumab administration
Maltese: Reazzjoni kardjovaskulari (inklużi ċerebrovaskulari) li temporanjament huma assoċjati malamministrazzjoni tal-alemtuzumab
English: Literature reports1, 2, 3 have highlighted B-cell mediated central nervous system (CNS) lesions with temporal onset of 6 months after infusion of alemtuzumab.
Maltese: Rapporti tal-letteratura1, 2, 3, enfasizzaw leżjonijiet tas-sistema nervuża ċentrali medjati biċ-ċellola B (CNS) b'bidu temporali ta' 6 xhur wara l-infużjoni tal-alemtuzumab.
English: Cases of Haemophagocytic lymphohistocytosis (HLH) were identified.
Maltese: Ġew identifikati każijiet ta' limfoħistjoċitożi emofagoċitika (HLH).
English: - Cardiovascular adverse events in close temporal association with Lemtrada infusions (e.g. cardiac ischaemia and myocardial infarction, ischaemic and haemorrhagic stroke, arterial dissection, pulmonary haemorrhage and embolism, vasculitis and thrombocytopenia), including a possible mechanistic relation to these adverse events.
Maltese: - Avvenimenti avversi kardjovaskulari f'assoċjazzjoni temporali mill-qrib ma' infużjonijiet ta' Lemtrada (eż. iskemija kardijaka u infart mijokardijaku, puplesija iskemika u emorraġika, dissezzjoni arterjali, emorraġija pulmonari u emboliżmu, vaskulite u tromboċitopenija), inkluża l-possibbiltà ta' konnessjoni mekkanika għal dawn l-avvenimenti avversi.
English: Scientific conclusions
Maltese: Konklużjonijiet xjentifiċi
English: Autoimmune disorders are an important identified risk for alemtuzumab.
Maltese: Disturbi awtoimmunitarji huma riskju importanti identifikat għal alemtuzumab.
English: During the assessment procedure of the periodic safety update report (PSUSA) for Lemtrada covering the period between 13 September 2017 and 12 September 2018, limited information was available on new emerging and serious safety concerns, including lack of detailed information on the individual cases, precluding a thorough evaluation.
Maltese: Matul il-proċedura ta' valutazzjoni tar-rapport perjodiku għall-aġġornament dwar is-sigurtà (PSUSA) għal Lemtrada li jkopri l-perjodu bejn it-13 ta' Settembru 2017 u t-12 ta' Settembru 2018, kien hemm disponibbli informazzjoni limitata dwar tħassib ġdid emerġenti u serju dwar is-sigurtà, inkluż nuqqas ta' informazzjoni dettaljata dwar il-każijiet individwali, li jipprekludu evalwazzjoni bir-reqqa.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Lemtrada, in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 of Directive 2001/83/EC.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat ta' data dwar il-farmakoviġilanza għal Lemtrada, b'mod partikolari rigward il-ħtieġa għal miżuri provviżorji skont l-Artikolu 20(3) tar-Regolament (KE) Nru 726/2004, filwaqt li jitqiesu r-raġunijiet stabbiliti fl-Artikolu 116 tad-Direttiva 2001/83/KE.
English: During the assessment of the periodic safety update report (PSUSA) for Lemtrada (EMEA/H/C/PSUSA/00010055/201809), the following new emerging and serious safety concerns were highlighted in addition to the known safety profile of alemtuzumab, which raised major concerns to the Pharmacovigilance Risk Assessment Committee (PRAC):
Maltese: Matul il-valutazzjoni tar-rapport perjodiku għall-aġġornament dwar is-sigurtà (PSUSA) għal Lemtrada (EMEA/H/C/PSUSA/00010055/201809), ġie enfasizzat it-tħassib emerġenti u serju ġdid li ġej dwar issigurtà flimkien mal-profil dwar is-sigurtà magħruf għal alemtuzumab, li qajjem tħassib kbir għallKumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC):
English: Both T and B lymphocytes are involved in the pathogenesis of MS. Alemtuzumab binds to CD52, a cell surface antigen present at high levels on T and B lymphocytes, and at lower levels on natural killer cells, monocytes and macrophages.
Maltese: L-alemtuzumab teħel mas-CD52, antiġen tas-superfiċje taċ-ċelloli preżenti f'livelli għoljin fil-limfoċiti T u B, u f'livelli aktar baxxi fuq iċ-ċelloli natural killer, il-monoċiti u l-makrofagi.
English: Several cases with various cardiovascular reactions were identified, including pulmonary alveolar haemorrhage, myocardial infarction, and ischaemic and haemorrhagic stroke as well as arterial dissection.
Maltese: Ġew identifikati diversi każijiet b'reazzjonijiet kardjovaskulari varji, inkluż emorraġija alveolari pulmonari, infart mijokardijaku, puplesija iskemika u emorraġika kif ukoll dissezzjoni arterjali.
English: This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) No 726/2004.
Maltese: Din ir-rakkomandazzjoni hija mingħajr preġudizzju għall-konklużjonijiet finali tal-proċedura li għadha għaddejja skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: - Immune-mediated diseases such as auto-immune hepatitis, hepatic injury, auto-immune-mediated central nervous system disease and Guillain-Barre syndrome.
Maltese: - Mard b'medjazzjoni immunitarja bħall-epatite awtoimmunitarja, il-korriment epatiku, il-marda tassistema nervuża ċentrali bil-medjazzjoni awtoimmunitarja u s-sindrome ta' Guillain-Barré.
English: There is little or no CD52 detected on neutrophils, plasma cells, or bone marrow stem cells.
Maltese: Hemm ftit li xejn jew ebda CD52 misjub fuq newtrofili, ċelloli tal-plażma, jew ċelloli staminali talmudullun.
English: New life-threatening and potentially fatal immune-mediated adverse reactions were identified, including haemophagocytic lymphohistocytosis and autoimmune hepatitis.
Maltese: Ġew identifikati reazzjonijiet avversi medjati mis-sistema immunitarja ġodda u potenzjalment fatali, inkluż l-limfoħistjoċitożi emofagoċitika u l-epatite awtoimmunitarja.
English: The PRAC recommended as part of the PSUSA procedure the addition of warnings related to serious reactions temporally associated with alemtuzumab infusion including pulmonary alveolar haemorrhage, myocardial infarction, stroke (including ischaemic and haemorrhagic stroke), cervicocephalic (e.g. vertebral, carotid) arterial dissection.
Maltese: Bħala parti mill-proċedura PSUSA, il-PRAC irrakkomanda ż-żieda ta' twissijiet relatati ma' reazzjonijiet serji temporanjament assoċjati ma' infużjoni tal-alemtuzumab li tinkludi emorraġija alveolari pulmonari, infart mijokardijaku, puplesija (inkluża puplesija iskemika u emorraġika), dissezzjoni arterjali ċervikoċefalika (eż. vertebrali, karotidi).
English: Overall summary of the scientific evaluation by the PRAC
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika mill-PRAC
English: Furthermore, the following new adverse reactions are added: pulmonary alveolar haemorrhage, haemophagocytic lymphohistiocytosis, myocardial infarction, stroke (including ischemic and haemorrhagic stroke), cervicocephalic arterial dissection and neutropenia.
Maltese: Barra minn hekk, ir-reazzjonijiet avversi ġodda li ġejjin huma miżjuda: emorraġija alveolari pulmonari, limfoħistjoċitożi emofagoċitika, infart mijokardijaku, puplesija (inkluża puplesija iskemika u emorraġika), dissezzjoni arterjali ċervikoċefalika u newtropenija.
English: Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system that is characterized by inflammation, demyelination and neuronal loss.
Maltese: L-isklerożi multipla (MS) hija marda infjammatorja u newrodeġenerattiva tas-sistema nervuża ċentrali li hija karatterizzata minn infjammazzjoni, demjelinazzjoni u telf newronali.
English: Limited information, including lack of detailed information on the individual cases, precluded a thorough evaluation of their impact on the benefit risk of Lemtrada in view of the time constraints for the PSUSA assessment.
Maltese: Informazzjoni limitata, inkluż nuqqas ta' informazzjoni dettaljata dwar il-każijiet individwali, ipprekludiet evalwazzjoni bir-reqqa tal-impatt tagħhom fuq ir-riskju ta' benefiċċju ta' Lemtrada fid-dawl tal-limiti ta' żmien għall-valutazzjoni PSUSA.
English: • The PRAC also reviewed the available data on immune-mediated adverse events, including data provided by the marketing authorisation holder in the context of the PSUSA procedure.
Maltese: • Il-PRAC irrieżami wkoll id-data disponibbli dwar avvenimenti avversi medjati mis-sistema immunitarja, inkluż data pprovduta mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq filkuntest tal-proċedura PSUSA.
English: Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to T and B lymphocytes.
Maltese: L-alemtuzumab taġixxi permezz ta' ċitoliżi ċellulari li hija dipendenti mill-antikorp u liżi kumplimentari-medjata wara li l-wiċċ taċ-ċelloli jeħel mal-limfoċiti T u B.
English: Therefore, in view of the seriousness of the events observed, the PRAC recommended provisional amendments to the product information to restrict use of alemtuzumab in new patients to adults with highly active relapsing remitting multiple sclerosis despite a full and adequate course of treatment with at least two other disease modifying treatments, or to adults with highly active relapsing remitting multiple sclerosis where all other disease modifying treatments are contraindicated or otherwise unsuitable.
Maltese: Għalhekk il-PRAC irrakkomanda li trattament ġdid b'Lemtrada għandu jinbeda biss f'pazjenti adulti bi sklerożi multipla li tirkadi-tbatti attiva ħafna minkejja kors sħiħ u adegwat ta' kura b'mill-inqas żewġ kuri oħra li jimmodifikaw il-marda, jew f'pazjenti adulti bi sklerożi multipla li tirkadi-tbatti attiva ħafna fejn il-kuri l-oħrajn kollha li jimmodifikaw il-marda huma kontraindikati jew inkella mhux adattati.
English: • In addition, several fatal cases were identified both in the literature and in the Eudravigilance database.
Maltese: • Barra minn hekk, ġew identifikati diversi każijiet fatali kemm fil-letteratura kif ukoll fil-bażi taddata tal-Eudravigilance.
English: The temporal onset corresponded to the time of reconstitution of the immune system after depletion of B- and T-lymphocytes following Lemtrada treatment.
Maltese: Il-bidu temporali kien jikkorrispondi mal-ħin tar-rikostituzzjoni tassistema immunitarja wara t-tnaqqis ta' limfoċiti B u T wara kura b'Lemtrada.
English: The PRAC also noted that recent literature reports have highlighted B-cell mediated central nervous system (CNS) lesions with temporal onset of 6 months after infusion of alemtuzumab.
Maltese: Il-PRAC innota wkoll li rapporti reċenti tal-letteratura enfasizzaw leżjonijiet tas-sistema nervuża ċentrali medjati biċ-ċellola B (CNS) b'bidu temporali ta' sitt (6) xhur wara l-infużjoni tal-alemtuzumab.
English: • The PRAC noted that although efficacy of alemtuzumab in relapsed remitting multiple sclerosis patients is well established, these emerging and serious safety concerns can impact the benefit-risk balance of Lemtrada, and that until a thorough review is finalised, it would be appropriate as a provisional measure to limit the patients exposed to alemtuzumab.
Maltese: • Barra minn hekk, il-PRAC ikkunsidra li huwa importanti li l-miżuri ta' minimizzazzjoni tar-riskju rakkomandati fi ħdan il-valutazzjoni tal-proċedura attwali tal-PSUSA jiġu wkoll implimentati flimkien mal-miżuri provviżorji.
English: • The applicant should submit the final results of the study 14701 by 28 February 2013.
Maltese: • L-applikant għandu jissottometti r-riżultati finali tal-istudju 14701 sat-28 ta' Frar 2013.
English: National Competent Authorities, coordinated by the Reference Member State as applicable, shall ensure the following:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill-Istat Membru ta' Referenza kif applikabbli, għandhom jiżguraw dan li ġej:
English: Conditions of the marketing authorisation
Maltese: Kundizzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq
English: EMA/513708/2016
Maltese: EMA/513708/2016 EMEA/H/C/004267
English: The full EPAR for Airexar Spiromax 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: Airexar Spiromax is a ‘hybrid medicine'.
Maltese: Airexar Spiromax huwa ‘mediċina ibrida'.
English: Since Airexar Spiromax is only available in one high strength (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower strength become appropriate, patients should be switched to an alternative combination of salmeterol and fluticasone propionate containing a lower
Maltese: Peress li Airexar Spiromax huwa disponibbli biss f'qawwa għolja waħda (li fiha 50 mikrogramma ta' salmeterol u 500 mikrogramma ta' fluticasone propionate), jekk ikun xieraq li tintuża qawwa aktar baxxa, il-pazjenti għandhom jinqalbu għal kombinazzjoni alternattiva ta' salmeterol u fluticasone propionate li fiha doża aktar baxxa ta' fluticasone propionate.
English: Salmeterol is a long-acting beta-2 agonist.
Maltese: Salmeterol huwa agonist tal-beta-2 li jaħdem fit-tul.
English: Airexar Spiromax is available as an inhalation powder in a portable inhaler device.
Maltese: Airexar Spiromax huwa disponibbli bħala trab għall-inalazzjoni f'inalatur portabbli.
English: It contains the active substances salmeterol (a so-called long-acting beta-2 agonist) and fluticasone
Maltese: Fih is-sustanzi attivi salmeterol (l-hekk imsejjaħ agonist tal-beta-2 li jaġixxi fit-tul) u fluticasone propionate (kortikosterojde).
English: Other information about Airexar Spiromax
Maltese: Informazzjoni oħra dwar Airexar Spiromax
English: This is a summary of the European public assessment report (EPAR) for Airexar Spiromax.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Airexar Spiromax.
English: This means that Airexar Spiromax is similar to a ‘reference medicine' called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active substances.
Maltese: Dan ifisser li Airexar Spiromax huwa simili għal ‘mediċina ta' referenza' msejħa Seretide Diskus (magħrufa wkoll bħala Seretide Accuhaler), li fiha l-istess sustanzi attivi.
English: Fluticasone propionate belongs to a group of anti-inflammatory medicines known as corticosteroids.
Maltese: Fluticasone propionate jagħmel parti minn grupp ta' mediċini antiinfjammatorji magħrufa bħala kortikosterojdi.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Maltese: Huwa jaħdem b'mod simili għal ormoni kortikosterojdi li jseħħu b'mod naturali, inaqqas l-attività tas-sistema immunitarja billi jintrabat ma' riċetturi f'diversi tipi ta' ċelloli immunitarji.
English: What are the benefits and risks of Airexar Spiromax?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Airexar Spiromax?
English: Airexar Spiromax is a medicine used for the regular treatment of adults with severe asthma and for the relief of symptoms of chronic obstructive pulmonary disease (COPD, a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing).
Maltese: Airexar Spiromax huwa mediċina li tintuża għall-kura regolari ta' adulti b'ażma severa u għas-serħan mis-sintomi ta' mard pulmonari ostruttiv kroniku (COPD, marda fit-tul li fiha l-passaġġi tan-nifs u lboroż tal-arja ġewwa l-pulmuni ssirilhom il-ħsara jew jisfaw imblokkati, u dan iwassal għal diffikultà fitteħid tan-nifs).
English: Because Airexar Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Airexar Spiromax huwa mediċina ibrida u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Studies in people have been limited to tests to determine that Airexar Spiromax is bioequivalent to the reference medicine, Seretide Diskus.
Maltese: L-istudji fuq persuni kienu limitati għal testijiet sabiex jiġi determinat li Airexar Spiromax huwa bijoekwivalenti għall-mediċina ta' referenza, Seretide Diskus.
English: Each inhalation provides a fixed dose of the medicine.
Maltese: Kull inalazzjoni tipprovdi doża fissa tal-mediċina.
English: In COPD, Airexar Spiromax is used in adults who have had exacerbations (flare-ups) of the disease in the past and have significant symptoms despite regular treatment.
Maltese: F'COPD, Airexar Spiromax jintuża f'adulti li fil-passat kellhom aggravar tal-marda u li għandhom sintomi sinifikanti minkejja kura regolari.
English: In asthma, Airexar Spiromax can be used in patients whose disease is not adequately controlled despite treatment with a combination of a beta-2 agonist and a lower dose of inhaled corticosteroid, or those whose asthma is already controlled with a long-acting beta-2 agonist and a high-dose of inhaled
Maltese: Fl-ażma, Airexar Spiromax jista' jintuża f'pazjenti li l-marda tagħhom ma tkunx ikkontrollata b'mod adegwat minkejja kura b'kombinazzjoni ta' agonist tal-beta-2 u doża aktar baxxa ta' kortikosterojde li jittieħed man-nifs, jew li l-ażma tagħhom tkun diġà kkontrollata b'agonist tal-beta-2 li jaġixxi fit-tul u doża għolja ta' kortikosterojde li jittieħed man-nifs.
English: The Committee recommended that Airexar Spiromax be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Airexar Spiromax ikun approvat għall-użu fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Airexar Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li Airexar Spiromax wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Seretide Diskus.
English: It works by attaching to receptors known as beta-2 receptors in the muscles of the airways.
Maltese: Jaħdem billi jeħel ma' riċetturi magħrufa bħala riċetturi beta-2 fil-muskoli tal-passaġġi tal-arja.
English: How has Airexar Spiromax been studied?
Maltese: Kif ġie studjat Airexar Spiromax?
English: How is Airexar Spiromax used?
Maltese: Kif jintuża Airexar Spiromax?
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: However, Airexar Spiromax is available only as a single high strength, whereas the reference medicine is available in three strengths, the same high strength and two lower strengths.
Maltese: Madankollu, Airexar Spiromax huwa disponibbli biss bħala qawwa għolja waħdanija, filwaqt li lmediċina ta' referenza hija disponibbli fi tliet qawwiet, l-istess qawwa għolja u żewġ qawwiet aktar baxxi.
English: Page 2/2
Maltese: Paġna 2/2
English: 2 February 2016 EMA/283374/2014
Maltese: EMA/283374/2014
English: Eleutherococcus root EMA/283374/2014
Maltese: Għerq tal-elewterokokku EMA/283374/2014
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom consulted if the symptoms continue for more than 2 weeks of treatment.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 ta' Frar 2016
English: Herbal medicine: summary for the public
Maltese: Mediċina tal-ħxejjex: sommarju għall-pubbliku
English: Eleutherococcus senticosus (Rupr.
Maltese: Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix