FrancophonIA/ELRC3.0 huggingface dataset:
English: In a main study involving 1,253 patients with advanced or metastatic non-small cell lung cancer which worsened despite treatment with medicines containing platinum, those treated with Cyramza and docetaxel lived longer than patients receiving docetaxel and placebo: on average 10.5 months versus 9.1 months respectively.
Maltese: Fi studju ewlieni li kien jinvolvi 1,253 pazjent b'kanċer tal-pulmun taċ-ċelloli mhux żgħar avvanzat jew metastatiku li aggrava minkejja kura b'mediċini li fihom il-platinu, dawk li ġew ikkurati b'Cyramza u docetaxel għexu aktar mill-pazjenti li kienu qed jirċievu docetaxel u plaċebo: bħala medja 10.5 xhur kontra 9.1 xhur rispettivament.
English: The safety profile of Cyramza is in line with that expected for other medicines blocking VEGFR activity and is considered manageable.
Maltese: Il-profil tas-sigurtà ta' Cyramza huwa f'konformità ma' dak mistenni għal mediċini oħrajn li jimblokkaw l-attività tal-VEGFR u huwa kkunsidrat maniġġabbli.
English: Although the effects were modest, the size of the benefit was considered clinically relevant given the normally poor prognosis in these patients.
Maltese: Għalkemm l-effetti kienu modesti, id-daqs talbenefiċċju kien ikkunsidrat klinikament rilevanti meta titqies il-pronjożi normalment fqira f'dawn ilpazjenti.
English: Similarly, in another study in 355 patients, those treated with Cyramza plus best supportive care lived longer than patients receiving placebo plus best supportive care (an average of 5.2 months versus 3.8 months, respectively).
Maltese: B'mod simili, fi studju ieħor fi 355 pazjent, dawk ikkurati b'Cyramza flimkien mal-aqwa kura ta' appoġġ għexu aktar minn pazjenti li kienu qed jirċievu plaċebo flimkien mal-aqwa kura ta' appoġġ (medja ta' 5.2 xhur kontra 3.8 xhur, rispettivament).
English: The Agency noted that Cyramza prolonged the lives of patients with gastric and gastro-oesophageal junction cancer when it was given with paclitaxel.
Maltese: L-Aġenzija nnutat li Cyramza tawwal il-ħajja tal-pazjenti b'kanċer gastriku u tal-ġunzjoni gastroesofagali meta ngħata ma' paclitaxel.
English: Cyramza is used on its own in patients with a high blood level of a protein called alpha fetoprotein (AFP) and who have been previously treated with sorafenib.
Maltese: Cyramza jintuża waħdu f'pazjenti b'livell għoli fid-demm ta' proteina li tissejjaħ alfa fetoproteina (AFP) u li qabel ikunu ġew ikkurati b'sorafenib.
English: In a study involving 292 patients with hepatocellular carcinoma that is advanced or cannot be removed with surgery and who have high AFP blood level and have been previously treated with sorafenib, patients receiving Cyramza lived longer than those receiving placebo: 8.5 versus 7.3 months, respectively.
Maltese: Fi studju li kien jinvolvi 292 pazjent b'karċinoma epatoċellulari li hija avvanzata jew li ma tistax titneħħa bil-kirurġija u li għandhom livell għoli ta' demm AFP u li qabel kienu kkurati b'sorafenib, ilpazjenti li kienu qed jirċievu Cyraza għexu aktar minn dawk li kienu qed jirċievu plaċebo: 8.5 xhur kontra 7.3 xhur, rispettivament.
English: The most common side effects with Cyramza (which may affect more than 1 in 10 people) include tiredness or weakness, leucopenia (low white blood cell counts), neutropenia (low counts of a particular type of white blood cell), diarrhoea, nosebleeds and stomatitis (inflammation of the lining of the mouth).
Maltese: L-effetti sekondarji l-aktar komuni b'Cyramza (li jistgħu jaffettwaw aktar minn persuna 1 minn 10) jinkludu għeja jew dgħjufija, lewkopenija (ammonti baxxi ta' ċelloli bojod tad-demm), newtropenija (ammonti baxxi ta' tip partikolari ta' ċelloli bojod tad-demm), dijarrea, tinfaraġ u stomatite (infjamazzjoni tar-rita tal-ħalq).
English: How is Cyramza used?
Maltese: Kif jintuża Cyramza?
English: What measures are being taken to ensure the safe and effective use of Cyramza?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Cyramza?
English: For the full list of side effects of Cyramza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Cyramza, ara l-fuljett ta' tagħrif.
English: Cyramza is used in combination with docetaxel in patients whose disease has worsened despite treatment with medicines containing platinum;
Maltese: Cyramza jintuża flimkien ma' docetaxel f'pazjenti li l-marda tagħhom tkun aggravat minkejja kura b'mediċini li fihom il-platinu.
English: Pharm. Res. 24, 73-80.
Maltese: Res. 24, 73-80.
English: Permeability/Absorption
Maltese: Permeabilità/Assorbiment
English: Solubility and dissolution
Maltese: Solubbilità u dissoluzzjoni
English: 3 Chen M. Straughn A, Sadrieh N. et al (2007).
Maltese: Straughn A, Sadrieh N. et al (2007).
English: “A Modern View of Excipient Effects on Bioequivalence: Case Study of Sorbitol”.
Maltese: “A Modern View of Excipient Effects on Bioequivalence:
English: Symposium der GD-Fachgruppe Magistralrezepturen: Neues zur Qualitätssicherung dermatologischer Rezepturen
Maltese: Symposium der GD-Fachgruppe Magistralrezepturen:
English: ‘Oral solutions
Maltese: ‘Soluzzjonijiet orali
English: The active ingredient in Okrido, prednisolone sodium phosphate, is ‘freely soluble in water' (Ph Eur).
Maltese: Is-sustanza attiva f'Okrido, prednisolone sodium phosphate, hija ‘liberament solubbli fl-ilma' (Ph Eur).
English: Okrido is an oral solution containing 6 mg/ml of the glucocorticoid prednisolone, as prednisolone sodium phosphate (PSP).
Maltese: Okrido huwa soluzzjoni orali li fiha 6 mg/ml tal-glukokortikojdi prednisolone, bħala prednisolone sodium phosphate (PSP).
English: The same requirements for similarity in excipients apply for oral solutions as for Biowaivers (see Appendix III, Section IV.2 Excipients).'
Maltese: L-istess rekwiżiti għal similarità fl-eċċipjenti japplikaw għal soluzzjonijiet orali bħal Biowaivers (ara l-Appendiċi III, Sezzjoni IV.2 Eċċipjenti).'
English: The MAH has submitted published clinical data (Lucas-Bouwmann 20011) to support the lack of a clinically relevant effect of sorbitol on prednisolone absorption.
Maltese: Il-MAH issottometta dejta klinika ppubblikata (Lucas-Bouwmann 20011) biex jappoġġja n-nuqqas ta' effett klinikament rilevanti ta' sorbitol fuq l-assorbiment ta' prednisolone.
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of Directive 2001/83/EC;
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-riferiment mibdija mir-Renju Unit skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE;
English: The excipient sorbitol is available in Okrido (500 mg/ml) and not in the reference medicinal product.
Maltese: L-eċċipjent sorbitol huwa disponibbli f'Okrido (500 mg/ml) u mhux fil-prodott mediċinali ta' referenza.
English: For Okrido, this equates to 0.536 mg/ml for prednisolone phosphate.
Maltese: Għal Okrido, dan huwa ugwali għal 0.536 mg/ml għal prednisolone phosphate.
English: Following transport across the Caco-2 cell monolayer, prednisolone was recovered in the range of 84% to 106% of the applied dose, whether as prednisolone sodium phosphate, Okrido oral solution or the reference medicinal product Prednisolone Sovereign soluble tablet.
Maltese: Wara t-trasport ġos-saff uniku ta' ċelloli Caco-2, prednisolone kien irkuprat fil-medda ta' 84% sa 106% tad-doża applikata, sew bħala prednisolone sodium phosphate, Okrido soluzzjoni orali jew il-prodott mediċinali ta' referenza
English: The MAH has provided solubility data which show that prednisolone sodium phosphate (PSP) is completely dissolved in water at a concentration of ~ 8.9 mg/ml, and that prednisolone remains in solution across the pH range of 1 to 8.
Maltese: Il-MAH ipprovda dejta dwar is-solubbilità li turi li prednisolone sodium phosphate (PSP) jinħall kompletament fl-ilma f'konċentrazzjoni ta' ~ 8.9 mg/ml, u li prednisolone jibqa' fis-soluzzjoni madwar il-firxa tal-pH ta' 1 sa 8.
English: - Prednisolone is rapidly and almost completely absorbed in the upper gastrointestinal tract.
Maltese: - Prednisolone jiġi assorbit b'mod mgħaġġel u jiġi kważi kompletament assorbit filpassaġġ gastrointestinali ta' fuq.
English: According to the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 rev 1), a drug substance is considered as highly soluble if the highest single dose administered as immediate release formulation(s) is completely dissolved in 250 ml of buffers within the range of pH 1 - 6.8 at 37±1 °C.
Maltese: Skont il-Linja Gwida tas-CHMP dwar l-Investigazzjoni ta' Bijoekwivalenza (CPMP/EWP/QWP/1401/98 rev 1), sustanza mediċinali hija meqjusa solubbli ħafna jekk l-ogħla doża unika mgħotija bħala formulazzjoni(jiet) b'rilaxx immedjat tinħall(jinħallu) kompletament f'250 ml ta' buffers fil-firxa ta' pH 1 - 6.8 f'37±1 °C.
English: The proposed indications for Okrido oral solution 6mg/ml include a wide range of conditions where symptomatic anti-inflammatory/ immunosuppressive therapy is required.
Maltese: L-indikazzjonijiet posposti għal Okrido soluzzjoni orali ta' 6mg/ml jinkludu firxa kbira ta' kundizzjonijiet fejn ikun hemm il-ħtieġa ta' terapija anti-infjammatorja/ immunosuppressiva sintomatika.
English: The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Maltese: Għalhekk is-CMDh irrefera lkwistjoni lis-CHMP permezz ta' proċedura ta' referenza tal-Art 29(4).
English: - Prednisolone (as sodium phosphate) exhibits high permeability as determined by the in vitro Caco-2 cell permeability model, and the permeability of Okrido is unaffected by the excipient sorbitol.
Maltese: - Prednisolone (bħala sodium phosphate) juri permeabilità għolja kif determinat millmudell in vitro tal-permeabilità taċ-ċelloli Caco-2, u l-permeabilità ta' Okrido mhijiex affettwata mill-eċċipjent sorbitol.
English: Solubility and/or dissolution are therefore not considered to be a limiting factor in terms of in vivo absorption.
Maltese: Issolubbilità u/jew id-dissoluzzjoni mhumiex meqjusa fatturi li jillimitaw f'termini ta' assorbiment in vivo.
English: Based on the submitted in-vitro Caco-2 monolayer cell model (permeability assay model), published literature and the oral explanation by the MAH on 26 June 2013, the CHMP considers that the biowaiver is acceptable, and therefore concluded that the benefit-risk balance for Okrido in the applied indications is favourable.
Maltese: Abbażi tal-mudell in-vitro ppreżentat ta' saff uniku ta' ċelloli Caco-2 (mudell tal-analiżi talpermeabilità), letteratura ppubblikata u l-ispjegazzjoni orali mill-MAH fis-26 ta' Ġunju 2013, isCHMP iqis li l-biowaiver hija aċċettabbli, u għalhekk ikkonkluda li l-bilanċ bejn il-benefiċċju u rriskju għal Okrido fl-indikazzjonijiet applikati huwa favorevoli.
English: Considering that the reference medicinal product and Okrido are oral solutions at the time of administration, the following provision of Appendix II of the Guideline on Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98, Rev.1) is applicable:
Maltese: Meta wieħed iqis li l-prodott mediċinali ta' referenza u Okrido huma soluzzjonijiet orali fil-ħin tal-għoti, id-dispożizzjoni li ġejja tal-Appendiċi II tal-Linja Gwida dwar l-Investigazzjoni ta' Bijoekwivalenza (CPMP/EWP/QWP/1401/98, Rev.1) hija applikabbli:
English: However if the excipients may affect gastrointestinal transit (e.g. sorbitol, mannitol, etc.), absorption (e.g. surfactants or excipients that may affect transport proteins), in vivo solubility (e.g. cosolvents) or in vivo stability of the active substance, a bioequivalence study should be conducted, unless the differences in the amounts of these excipients can be adequately justified by reference to other data.
Maltese: Madankollu jekk l-eċċipjenti jistgħu jaffettwaw it-tranżitu gastrointestinali (eż. sorbitol, mannitol, eċċ.), l-assorbiment (eż. surfetanti jew eċċipjenti li jistgħu jaffettwaw il-proteini ta' trasport), issolubbilità in vivo (eż. kosolventi) jew l-istabbiltà in vivo tas-sustanza attiva, għandu jsir studju ta' bijoekwivalenza, sakemm id-differenzi fl-ammonti ta' dawn l-eċċipjenti jistgħu jiġu adegwatament iġġustifikati b'referenza għal dejta oħra.
English: The indications and posology are consistent with those of the cited reference medicinal product Prednisolone Tablets Sovereign (5 mg soluble tablet).
Maltese: L-indikazzjonijiet u l-pożoloġija huma konsistenti ma' dawk talprodott ta' referenza kkwotat Prednisolone Tablets Sovereign (pillola li tinħall ta' 5 mg).
English: The MAH has also provided the abstract of an observational study (Staubach 20102) to support the clinical efficacy of the oral prednisolone solution containing sorbitol on emergency care patients presenting with urticaria and/or Quincke´s oedema.
Maltese: Il-MAH ipprovda wkoll astratt ta' studju ta' osservazzjoni (Staubach 20102) biex jappoġġja leffikaċja klinika tas-soluzzjoni orali ta' prednisolone li fiha sorbitol fuq pazjenti fuq kura ta' emerġenza li jippreżentaw b'urtikarja u/jew edema ta' Quincke.
English: Indeed Chen et al3 (2007)4 showed that in the presence of sorbitol, Cmax and AUC of ranitidine (BCS class III, low permeability substance) were significantly reduced while only the Cmax of metoprolol (BCS class I
Maltese: Tabilħaqq Chen et al3 (2007)4 urew li fil-preżenza ta' sorbitol, is-Cmax u
English: One of the key excipients in Okrido is sorbitol which is included as a sweetener and is present at a concentration of 500 mg/ml (total amount at the highest dose being 8.3g) in the medicinal product.
Maltese: Wieħed mill-eċċipjenti ewlenin f'Okrido huwa sorbitol li huwa inkluż bħala dolċifikant u huwa preżenti f'konċentrazzjoni ta' 500 mg/ml (l-ammont totali fl-ogħla doża huwa ta' 8.3g) fil-prodott mediċinali.
English: • The Committee therefore concluded that biowaver was justified and the risk-benefit balance for Okrido in the applied indications is favourable,
Maltese: • Għalhekk il-Kumitat ikkonkluda li l-biowaiver kien ġustifikat u l-bilanċ bejn il-benefiċċju u rriskju għal Okrido fl-indikazzjonijiet applikati huwa favorevoli,
English: The cited reference medicinal product Prednisolone Tablets Sovereign (5 mg soluble tablet), does not contain sorbitol and is recommended to be dissolved in water at the time of administration.
Maltese: Il-prodott mediċinali ta' referenza kkwotat Prednisolone Tablets Sovereign (pillola li tinħall ta' 5 mg), ma fihx sorbitol u huwa rrakkomandat li jinħall fl-ilma fil-ħin tal-għoti.
English: Permeability has been investigated using in vitro Caco-2 monolayer cell model and the results showed that prednisolone exhibits high permeability characteristic of BCS class I substances, and also that the permeability of prednisolone is not significantly affected by the excipient sorbitol in Okrido.
Maltese: Il-permeabilità ġiet investigata bl-użu tal-mudell ta' saff uniku ta' ċelloli Caco-2 u r-riżultati wrew li prednisolone juri permeabilità għolja karatteristika ta' sustanzi tal-klassi I tal-BCS, u wkoll li lpermeabilità ta' prednisolone mhijiex affettwata b'mod sinifikanti mill-eċċipjent sorbitol f'Okrido.
English: • The Committee reviewed all the data submitted by the marketing authorisation holder to address the potential serious risk to public health with regard to the efficacy and safety for Okrido 6 mg/ml oral solution.
Maltese: • Il-Kumitat irreveda d-dejta kollha sottomessa mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq sabiex jiġi indirizzat ir-riskju serju potenzjali għas-saħħa pubblika fir-rigward taleffikaċja u s-sigurtà għal Okrido 6 mg/ml soluzzjoni orali.
English: This is in accordance with bioavailability literature data of prednisolone.
Maltese: Dan huwa skont id-dejta dwar il-bijodisponibilità ta' prednisolone fil-letteratura.
English: The applicant has submitted the results of an in vitro investigation of the permeability of prednisolone using validated methodology involving the Caco-2 monolayer cell model.
Maltese: L-applikant ippreżenta r-riżultati ta' investigazzjoni in vitro tal-permeabiltà ta' prednisolone bl-użu ta' metodoloġija validata li tinvolvi l-mudell ta' saff uniku ta' ċelloli Caco-2.
English: The permeability data is reflective of the available literature, which indicates that prednisolone is rapidly and almost completely absorbed across the upper gastrointestinal tract.
Maltese: Id-dejta dwar il-permeabilità tirrifletti l-letteratura disponibbli, li tindika li prednisolone jiġi assorbit b'mod mgħaġġel u jiġi kważi kompletament assorbit mill-passaġġ gastrointestinali ta' fuq.
English: The Scientific Expert Statements provided by the MAH, suggest that prednisolone is rapidly and almost completely absorbed passively from the upper gastrointestinal tract (stomach, duodenum and small intestines) before reaching the colon, where sorbitol at a sufficiently high concentration may exert some osmotic laxative effect.
Maltese: Id-Dikjarazzjonijiet Xjentifiċi Esperti pprovduti mill-MAH, jissuġġerixxu li prednisolone jiġi assorbit b'mod mgħaġġel u jiġi kważi kompletament assorbit b'mod passiv mill-passaġġ gastrointestinali ta' fuq (l-istonku, id-duwodenu u l-musrana ż-żgħira) qabel ma jilħaq il-kolon, fejn f'konċentrazzjoni għolja biżżejjed sorbitol jista' jeżerċita xi effett lassattiv osmotiku.
English: The permeability data is reflective of the available literature data, which indicate that prednisolone is rapidly and almost completely absorbed passively from the upper gastrointestinal tract.
Maltese: Id-dejta dwar il-permeabilità tirrifletti d-dejta disponibbli mil-letteratura, li tindika li prednisolone jiġi assorbit b'mod mgħaġġel u jiġi kważi kompletament assorbit b'mod passiv mill-passaġġ gastrointestinali ta' fuq.
English: The mutual recognition marketing authorisation application (MAA) for Okrido was submitted in the UK as a generic medicinal product under article 10(1) of Directive 2001/83/EC, and the marketing authorisation was granted by the UK on the basis of a biowaiver.
Maltese: L-applikazzjoni għal rikonoxximent reċiproku għall-awtorizzazzjoni għat-tqegħid fis-suq (MAA) għal Okrido intbagħtet lir-Renju Unit bħala prodott mediċinali ġeneriku skont l-Artikolu 10(1) tadDirettiva 2001/83/KE, u l-awtorizzazzjoni għat-tqegħid fis-suq ingħatat mir-Renju Unit abbażi ta' biowaiver.
English: In summary, the results of the in vitro investigation of the permeability of prednisolone using the Caco-2 cell model showed that prednisolone exhibits high permeability, characteristic of BCS class I substances, and also that the permeability of prednisolone is not affected by the excipient sorbitol in Okrido.
Maltese: Fil-qosor, ir-riżultati tal-investigazzjoni in vitro tal-permeabilità ta' prednisolone bl-użu tal-mudell taċ-ċelloli Caco-2 urew li prednisolone juri permeabilità għolja, karatteristika ta' sustanzi tal-klassi I tal-BCS, u wkoll li l-permeabilità ta' prednisolone mhijiex affettwata mill-eċċipjent sorbitol f'Okrido.
English: • The Committee also noted the literature data that was submitted, which showed that sorbitol in oral prednisolone solutions would not exert a clinically relevant effect in terms of efficacy and safety, although recognised that this literature was less relevant to the consideration of the biowaver.
Maltese: • Il-Kumitat innota wkoll id-dejta mil-letteratura li ġiet sottomessa, li wriet li sorbitol f'soluzzjonijiet orali ta' prednisolone ma kienx se jeżerċita effett klinikament rilevanti f'termini ta' effikaċja u sigurtà, għalkemm irrikonoxxa li din il-letteratura kienet anqas rilevanti għallkunsiderazzjoni tal-biowaiver.
English: Crushed prednisolone tablets were compared to prednisolone syrup (with sorbitol), in children with acute asthma, using dyspnoea as clinical end point.
Maltese: Pilloli mgħaffġa ta' prednisolone kienu mqabbla ma' xiropp ta' prednisolone (b'sorbitol), fit-tfal b'ażżma akuta, bl-użu ta' dispneja bħala l-punt ta' tmiem kliniku.
English: It is acknowledged that sorbitol can increase gastrointestinal motility, as a consequence of its osmotic effect, thereby reducing gastrointestinal transit time, which in turn can reduce drug absorption.
Maltese: Ġie rikonoxxut li sorbitol jista' jżid il-motilità gastrointestinali, bħala konsegwenza tal-effett osmotiku tiegħu, u b'hekk inaqqas iż-żmien ta' tranżitu gastrointestinali, li dan jista' jnaqqas lassorbiment tal-mediċina.
English: Scientific conclusions
Maltese: KONKLUŻJONIJIET XJENTIFIĊI
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 December 2014 EMA/300/2015
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Diċembru 2014
English: Outcome of a procedure under Article 13(2) of Regulation (EC) 1234/2008
Maltese: Riżultat ta' proċedura skont l-Artikolu 13(2) tar-Regolament (KE) 1234/2008
English: The company wanted the authorisation for the additional use in restless legs syndrome to be recognised in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni għall-użu addizzjonali fis-sindromu ta' riġlejn irrekwieti tiġi rikonoxxuta fl-Istati Membri li ġejjin: l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, idDanimarka, l-Estonja, il-Finlandja, Franza, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Lussemburgu, ilPajjiżi l-Baxxi, in-Norveġja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja, lIsvezja u r-Renju Unit (l-Istati Membri ”konċernati”).
English: Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride)
Maltese: Mistoqsijiet u tweġibiet fuq Oxynal, Targin u ismijiet assoċjati (oxycodone hydrochloride / naloxone hydrochloride)
English: The Committee concluded that the benefits of Oxynal, Targin and associated names outweigh their risks in the new use and the change to the marketing authorisation can be granted in Germany and the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
Maltese: Il-Kumitat ikkonkluda li l-benefiċċji ta' Oxynal, Targin u ismijiet assoċjati jegħlbu r-riskji tagħhom fl-użu l-ġdid u l-bidla għall-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fil-Ġermanja u fl-Istati Membri li ġejjin: l-Awstrija, il-Belġju, ilBulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, Franza, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Lussemburgu, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, ir-Rumanija, il-Portugall, isSlovakkja, is-Slovenja, Spanja, l-Isvezja u r-Renju Unit.
English: What are Oxynal and Targin?
Maltese: X'inhuma Oxynal u Targin?
English: Oxynal and Targin contain two active substances: oxycodone hydrochloride, an opioid painkiller, and naloxone hydrochloride, an opioid antagonist, which is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors found locally in the gut.
Maltese: Oxynal u Targin fihom żewġ sustanzi attivi: oxycodone hydrochloride, analġesiku opjojde, u naloxone hydrochloride, antagonista opjojde, li jiġi miżjud biex jaħdem kontra stitikezza indotta minn opjojdi billi jimblokka l-azzjoni oxycodone f'riċetturi tal-opjojdi li jinstabu lokalment fl-imsaren.
English: The company that markets these medicines is Mundipharma GmbH.
Maltese: Il-kumpanija li tqiegħed dawn il-prodotti fis-suq hija Mundipharma GmbH.
English: Why was Oxynal and Targin reviewed?
Maltese: Għaliex ġew riveduti Oxynal u Targin?
English: In November 2012, the company for Oxynal and Targin applied for an additional use in Germany: treatment of symptoms of severe to very severe restless legs syndrome when treatment with other medicines called dopaminergics has failed.
Maltese: F'Novembru 2012, il-kumpanija għal Oxynal u Targin applikat għal użu addizzjonali fil-Ġermanja: kura għal sintomi tas-sindromu ta' riġlejn irrekwieti severi sa severi ħafna meta tkun falliet kura b'mediċini oħrajn imsejħun dopaminerġiċi.