FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of hepatitis B re-activation (some with severe consequences) have been reported in patients coinfected with hepatitis B and C viruses treated with interferon.
Maltese: Ġew irrappurtati każijiet ta' riattivazzjoni tal-epatite B (xi wħud b'konsegwenzi severi) f'pazjenti infettati fl-istess ħin bil-virusijiet tal-epatite B u Ċ ikkurati b'interferon.
English: Long-term data available in children treated with the combination therapy of pegylated interferon/ribavirin are indicative of substantial growth retardation.
Maltese: Dejta fit-tul disponibbli dwar tfal ikkurati bit-terapija kombinata ta' interferon pegilat/ribavirin tindika ttardjar sostanzjali fit-tkabbir.
English: EU/1/00/132/011 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/012 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab)
Maltese: EU/1/00/132/012 (kunjett wieħed ta' trab, ampulla waħda ta' solvent, siringa waħda għall-injezzjoni, 2 labriet tal-injezzjoni u mselħa waħda biex tnaddaf) EU/1/00/132/013 (4 kunjetti ta' trab, 4 ampulli ta' solvent)
English: Dispose of the syringe and needles safely in a closed container.
Maltese: Armi s-siringa u l-labar b'mod sigur f'kontenitur magħluq.
English: Important information about some of the ingredients of ViraferonPeg Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' ViraferonPeg Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, assorbiment ħażin ta' glucose galactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: Table 2b Two-step dose reduction of ViraferonPeg in combination therapy in adults First dose reduction to ViraferonPeg 1 µg/kg
Maltese: Tabella 2b Tnaqqis f'żewġ fażijiet fid-doża ta' ViraferonPeg f'terapija kkombinata fl-adulti
English: The PRAC adopted a recommendation on 6 July 2017 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni, fis-6 ta' Lulju 2017 li dak iż-żmien ġiet ikkunsidrata mis-CMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: Solu-Medrol 40 mg powder and solvent for solution for injection (hereinafter ‘Solu-Medrol') contains methylprednisolone and, as an excipient, lactose monohydrate derived from bovine milk.
Maltese: Solu-Medrol 40 mg trab u solvent għal soluzzjoni għall-injezzjoni (minn hawn ‘il quddiem imsejjaħ ‘Solu-Medrol') fih methylprednisolone u, bħala eċċipjent lactose monohydrate derivat mill-ħalib talbovini.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for medicinal products containing lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions (see Annex I).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li tirriżulta minn data dwar il-farmakoviġilanza għal prodotti mediċinali li fhom lattożju ta' oriġini bovina għal użu ġol-vini/ġol-muskoli (IV/IM) f'kondizzjonijiet allerġiċi akuti (ara Anness I).
English: Methylprednisolone-containing products formulated with lactose of bovine origin are authorised for IV/IM use in a range of different indications across EU MSs, including in relation to acute allergic conditions.
Maltese: Prodotti li fihom methylprednisolone fformulati b'lattożju ta' oriġini bovina huma awtorizzati għal użu IV/IM f'medda ta' indikazzjoniijet differenti fost l-MSs tal-UE, inkluż fir-rigward ta' kondizzjonijiet allerġiċi akuti.
English: The PRAC noted that estimates of prevalence of cow's milk allergy on double blind placebo controlled oral food challenge varies from 0% to 3% and is higher in children than adults.
Maltese: Il-PRAC innota li stimi ta' prevalenza ta' allerġija għall-ħalib tal-baqra dwar sfida tal-ikel orali kkontrollata bil-plaċebo double-blind ivarjaw minn 0 % għal 3 % u hija ogħla fit-tfal milli fl-adulti.
English: The summary of products characteristics (SmPC) and patient leaflet (PL) should be amended accordingly.
Maltese: Is-sommarju tal-karatteristiċi tal-prodott (SmPC, summary of products characteristics) u l-fuljett ta' tagħrif (PL, patient leaflet) għandhom jiġu emendati kif xieraq.
English: When considering all the data submitted by the marketing authorisation holders (MAHs), in relation to the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin, as well as data available in Eudravigilance and the literature, the PRAC was of the view that medicinal products containing lactose of bovine origin for IV/IM use in acute allergic conditions are associated with a risk of serious allergic reactions in patients allergic to cow's milk.
Maltese: Meta tiġi kkunsidrata d-data kollha ppreżentata mid-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq (MAHs, marketing authorisation holders) fir-rigward tar-riskju ta' reazzjonijiet allerġiċi serji f'pazjenti allerġiċi għall-ħalib tal-baqra kkurati għal kondizzjonijiet allerġiċi akuti bi prodotti li fihom methylprednisolone fformulati b'lattożju ta' oriġini bovina, kif ukoll id-data disponibbli f'Eudravigilance u fil-letteratura, il-PRAC kien tal-fehma li prodotti mediċinali li fihom lattożju ta' oriġini bovina għal użu IV/IM f'kondizzjonijiet allerġiċi akuti huma assoċjati ma' riskju ta' reazzjonijiet allerġiċi serji f'pazjenti allerġiċi għall-ħalib tal-baqra.
English: The PRAC concluded that the benefit-risk balance of methylprednisolone-containing products formulated with lactose of bovine origin for intravenous/intramuscular (IV/IM) use in acute allergic conditions remains favourable, provided the MAHs replace the current formulations with formulations free from cow's milk proteins and submit for assessment the corresponding documentation to the relevant National Competent Authorities by end of June 2019 and provided the agreed changes to the product information are implemented in the interim.
Maltese: Il-PRAC ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti li fihom methylprednisolone fformulati b'lattożju ta' oriġini bovina għal użu ġol-vini/ġol-muskoli (IV/IM) f'kondizzjonijiet allerġiċi akuti jibqa' favorevoli, diment li l-MAHs jissostitwixxu l-formulazzjonijiet attwali b'formulazzjonijiet mingħajr proteini tal-ħalib tal-baqra u biex id-dokumentazzjoni korrispondenti tiġi ppreżentata għal valutazzjoni lill-Awtoritajiet Nazzjonali Kompetenti relevanti sal-aħħar ta' Ġunju 2019 u diment li ttibdil fl-informazzjoni dwar il-prodott li jkun intlaħaq ftehim dwaru jiġi implimentat fl-interim.
English: • The PRAC reviewed the totality of the data provided by the marketing authorisation holders, in relation to the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin, as well as data available in Eudravigilance and the literature.
Maltese: • Il-PRAC irreveda t-totalità tad-data pprovduta mid-detenturi tal-awtorizzazzjoni għattqegħid fis-suq, fir-rigward tar-riskju ta' reazzjonijiet allerġiċi serji f'pazjenti allerġiċi għallħalib tal-baqra kkurati għal kondizzjonijiet allerġiċi akuti bi prodotti li fihom methylprednisolone fformulati b'lattożju ta' oriġini bovina, kif ukoll data disponibbli f'Eudravigilance u fil-letteratura.
English: On 21 November 2016 the Croatian NCA therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of all medicinal products for intravenous or intramuscular administration containing lactose derived from bovine milk used in the treatment of acute allergy and anaphylactic shock and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Għaldaqstant, fil-21 ta' Novembru 2016, l-NCA Kroata tat bidu għal referenza skont l-Artikolu 31 tad-Direttiva 2001/83/KE bħala riżultat tad-data dwar il-farmakoviġilanza, u talbet lill-PRAC jivvaluta l-impatt tat-tħassib imsemmi hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju talprodotti mediċinali kollha għal għoti ġol-vini jew ġol-muskoli li fihom il-lattożju derivat minn ħalib tal-bovini użati fil-kura ta' allerġija akuta jew xokk anafilattiku u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: • The PRAC notes that data currently available does not allow establishing a safe threshold for milk proteins in lactose of bovine origin used as excipient in methylprednisolonecontaining products for IV/IM use in acute allergic conditions.
Maltese: • Il-PRAC jinnota li d-data li hemm disponibbli bħalissa ma tippermettix li jiġi stabbilit limitu sigur għall-proteini tal-ħalib f'lattożju ta' oriġini bovina bħala eċċipjent fi prodotti li fihom methylprednisolone għal użu IV/IM f'kondizzjonijiet allerġiċi akuti.
English: • The PRAC considers that, in patients allergic to cow's milk, a risk of serious allergic reactions, including anaphylactic reactions, is associated to IV/IM treatment of acute allergic conditions with methylprednisolone-containing products formulated with lactose of bovine origin.
Maltese: • Il-PRAC jikkunsidra li, f'pazjenti allerġiċi għall-ħalib tal-baqra, riskju ta' reazzjonijiet allerġiċi serji, inkluż reazzjonijiet anafilattiċi, huwa assoċjat ma' kura IV/IM ta' kondizzjonijiet allerġiċi akuti bi prodotti li fihom methylprednisolone fformulati b'lattożju ta' oriġini bovina.
English: Serious cases of allergic reactions have been reported in patients allergic to cow's milk administered Solu-Medrol for acute allergic conditions, including cases reporting a positive skin prick test for Solu-Medrol, a skin test for immunoglobulin E mediated allergic response.
Maltese: Ġew irrappurtati każijiet serji ta' reazzjonijiet allerġiċi f'pazjenti allerġiċi għall-ħalib talbaqra li ngħataw Solu-Medrol għal kondizzjonijiet allerġiċi akuti, inkluż każijiet li rrappurtaw test ta' qris tal-ġilda pożittiv għal Solu-Medrol, test tal-ġilda għal rispons allerġiku medjat minn immunoglobulina E.
English: In view of the above, the Croatian national competent authority (NCA) HALMED considered that the risk of serious allergic reactions in patients allergic to cow's milk treated for acute allergic conditions with intravenous/intramuscular (IV/IM) medicinal products containing as excipient lactose from bovine origin should be reviewed.
Maltese: Fid-dawl ta' dan ta' hawn fuq, l-awtorità nazzjonali kompetenti (NCA, national competent authority) Kroata HALMED ikkunsidrat li r-riskju ta' reazzjonijiet allerġiċi serji f'pazjenti allerġiċi għall-ħalib tal-baqra kkurati għal kondizzjonijiet allerġiċi akuti bi prodotti mediċinali ġol-vini/ġol-muskoli (IV/IM, intravenous/intramuscular) li bħala eċċipjent fihom il-lattożju minn oriġini bovina għandu jiġi revedut.
English: It was noted that in the European Union member states (EU MS), Norway and Iceland, at start of the procedure, medicinal products formulated with lactose of bovine origin and authorised for IV/IM use in acute allergic conditions, and therefore concerned by this procedure, were limited to certain strengths of methylprednisolone-containing products.
Maltese: Ġie nnutat li fl-Istati Membri tal-Unjoni Ewropea (EU MS, European Union member states), in-Norveġja u l-Iżlanda, fil-bidu tal-proċedura, prodotti mediċinali fformulati b'lattożju ta' oriġini bovina u awtorizzati għal użu IV/IM f'kondizzjonijiet allerġiċi akuti, u li għalhekk huma kkonċernati minn din il-proċedura, ġew limitati għal ċerti qawwiet ta' prodotti li fihom methylprednisolone.
English: Having reviewed the PRAC recommendation, the CMDh agrees with the PRAC overall conclusions and grounds for recommendation.
Maltese: Wara li ġiet riveduta r-rakkomandazzjoni tal-PRAC, is-CMDh jaqbel mal-konklużjonijiet u rraġunijiet globali għar-rakkomandazzjoni tal-PRAC.
English: • The PRAC concludes that the risk of serious allergic reactions should be minimised through inclusion in the product information of a contraindication in patients allergic to cow's milk and warnings to inform health care professionals and patients of this risk.
Maltese: • Il-PRAC jikkonkludi li r-riskju ta' reazzjonijiet allerġiċi serji għandu jiġi mminimizzat permezz ta' inklużjoni fl-informazzjoni dwar il-prodott ta' kontraindikazzjoni f'pazjenti allerġiċi għall-ħalib tal-baqra u ta' twissijiet sabiex jinfurmaw lill-professjonisti tal-kura tassaħħa u lill-pazjenti dwar dan ir-riskju.
English: As SoluMedrol is administered for an acute allergic condition, any anaphylactic reaction possibly caused by the traces of milk proteins in the product, may be misinterpreted as a lack of therapeutic effect, delaying adequate patient care.
Maltese: Peress li Solu-Medrol jingħata għal kondizzjoni allerġika akuta, kwalunkwe reazzjoni anafilattika possibbilment ikkawżata minn traċċi ta' proteini tal-ħalib fil-prodott, tista' tiġi interpretata ħażin bħala nuqqas ta' effett terapewtiku, li ddewwem il-kura adegwata ta' pazjent.
English: The PRAC considered that methylprednisolone containing products formulated with lactose of bovine origin must not be used in patients allergic to cow's milk.
Maltese: Il-benefiċċji ta' prodotti li fihom methylprednisolone, jew waħidhom jew bħala terapija aġġuntiva, fil-kura ta' kondizzjonijiet allerġiċi akuti ġew stabbiliti kif rifless fil-linji gwida tal-kura.
English: Taking into account the severity and seriousness of conditions when methylprednisolone-containing products are used, the necessity for rapid management, the absence of a safe threshold of exposure and the population at risk, the PRAC considered that the traces of milk proteins shall be excluded from these methylprednisolone-containing products in order to fully address this risk.
Maltese: Meta jiġu kkunsidrati s-severità u s-serjetà ta' kondizzjonijiet meta jintużaw prodotti li fihom methylprednisolone, il-ħtieġa għal immaniġġjar mgħaġġel, in-nuqqas ta' limitu sigur ta' esponiment u l-popolazzjoni f'riskju, il-PRAC ikkunsidra li t-traċċi tal-proteini tal-ħalib għandhom jiġu esklużi minn dawn il-prodotti li fihom methylprednisolone sabiex dan ir-riskju jiġi indirizzat b'mod sħiħ.
English: A letter should also be disseminated to relevant HCPs to inform of the above mentioned risk and measures recommended to minimise it.
Maltese: Għandha titqassam ukoll ittra lill-HCPs relevanti sabiex tinfurmahom dwar ir-riskju msemmi hawn fuq u l-miżuri rakkomandati sabiex jiġi mminimizzat.
English: The Rapporteur and Co-Rapporteur appointed were Dr Julia Dunne and Dr Ingemar Persson, respectively.
Maltese: Ir-Rapporteur u l-Ko-Rapporteur maħtura kienu Dr Julia Dunne u Dr Ingemar Persson, rispettivament.
English: International Non-Proprietary Name (INN): bicalutamide
Maltese: Mhux Patentat (INN): bicalutamide
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68
Maltese: (44-20) 74 18 86 00 Fax (44-20) 74 18 84 68
English: Bicalutamide is an oral anti-androgen used in the management of prostate cancer.
Maltese: Bicalutamide hu anti-androġenu orali użat fil-ġestjoni tal-kanċer tal-prostata.
English: London, 16 August 2007 EMEA/378451/2007
Maltese: EMEA/378451/2007
English: It is also approved in Norway and Iceland.
Maltese: Hu approvat ukoll fin-Norveġja u fl-Iżlanda.
English: The final opinion was converted into a Decision by the European Commission on 03.09.2007.
Maltese: L-opinjoni finali ġiet konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fil-03.09.2007.
English: Bicalutamide 150 mg-containing medicinal products (See Annex 1)
Maltese: Prodotti mediċinali li fihom Bicalutamide 150 mg (Ara l-Anness 1)
English: 16 August, 2007
Maltese: 27 ta' Awwissu 2007
English: On 27 July 2006, Belgium presented a referral to the EMEA under Article 31 of Directive 2001/83, as amended.
Maltese: Fis-27 ta' Lulju 2006, il-Belġju ppreżenta riferiment lill-EMEA skond l-Artikolu 31 tad-Direttiva 2001/83, kif emendata.
English: Written explanations were provided by the Marketing Authorisation Holders on 20 October 2006, 22 March 2007 and on 15 May 2007.
Maltese: Ingħataw tifsiriet bil-miktub lid-Detentur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq fl-20 ta' Ottubru 2006, fit-22 ta' Marzu 2007 u fil-15 ta' Mejju ta' l
English: - the lack of an overall survival benefit versus adverse events in ‘locally advanced prostate cancer'; - statistical concerns regarding multiplicity; - the standard of care for the placebo group in the relevant studies; - the number of deaths due to cardiac failure.
Maltese: - in-nuqqas ta' benefiċċju globali ta' sopravivenza meta mqabbel ma' l-avvenimenti avversi fil-'kanċer talprostata avvanzat lokalment '; - tħassib statistiku dwar il-multiċipliċità; - l-istandard tal-kura tal-grupp tal-plaċebo fl-istudji relevanti; - l-għadd ta' mwiet minħabba indeboliment kardijaku.
English: The CHMP considered that bicalutamide 150 mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to treatment of patients at high risk of disease progression.
Maltese: Is-CHMP ikkonsidra li bicalutamide 150 mg hu effettiv fit-trattament tal-kankru tal-prostata avvanzat lokalment; madankollu s-CHMP ikkonsidra li l-indikazzjoni terapewtika għandha tkun ristetta għattrattament ta' pazjenti b'riskju għoli ta' progress tal-marda.
English: Based on evaluation of the available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of bicalutamide 150 mg-containing medicinal products remains favourable, and therefore adopted an opinion on 24 May 2007 recommending the maintenance or the granting, as appropriate, of the Marketing Authorisations with amendments to the relevant sections of the Summary of Product Characteristics, for bicalutamide 150 mg-containing medicinal products.
Maltese: Skond l-evalwazzjoni tad-dejta disponibbli u tar-rapporti ta' valutazzjoni tar-Rapporteurs, is-CHMP ikkonsidra li l-profil tal-benefiċċju/riskju ta' mediċini li fihom bicalutamide 150 mg jibqa' wieħed favorevoli, u għalhekk adotta opinjoni fl-24 ta' Mejju ta' l-2007 li tirrakkomanda ż-żamma jew l-għoti, kif inhu xieraq, ta' l-Awtorizzazzjonijiet tat-Tqegħid fis-Suq bl-emendi għat-taqsimiet relevanti tasSommarju tal-Karatteristiċi tal-Prodott għal prodotti mediċinali li fihom bicalutamide 150 mg.
English: Oral explanations were given on 22 May 2007.
Maltese: Ingħataw tifsiriet orali fit-22 ta' Mejju 2007.
English: The reasons for referral concerned a review of the benefit/risk profile of medicinal products containing bicalutamide 150 mg.
Maltese: Ir-raġunijiet għar-riferiment kellhom x'jaqsmu ma' analiżi tal-profil talbenefiċċju/riskju ta' prodotti mediċinali li fihom bicalutamide 150 mg.
English: BACKGROUND INFORMATION
Maltese: Isem Internazzjonali
English: Locally advanced prostate cancer refers to larger tumours or tumours with spread to lymph nodes, but not involving spread to other organs.
Maltese: Kanċer tal-prostata lokalment avvanzat jirreferi għal tumuri kbar jew tumuri li jkunu nfirxu għan-noduli limfatiċi, iżda li ma jkunux infirxu għal organi oħra.
English: SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 31 OF COUNCIL DIRECTIVE 2001/83/EC, AS AMENDED, FOR
Maltese: FIL-QOSOR DWAR L-OPINJONI TA' RIFERIMENT SKOND L-ARTIKOLU 31 TAD-DIRETTIVA TAL-KUNSILL 2001/83/KE, KIF EMENDATA GĦAL
English: Its authorised indications include the treatment of patients with locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Maltese: L-indikazzjonijiet awtorizzati tiegħu jinkludu t-trattament ta' pazjenti b'kanċer tal-prostata avvanzat lokalment, bħala terapija immedjata jew waħdu jew bħala għajnuna għat-trattament bit-tneħħija radikali tal-prostata jew bir-radjuterapija.
English: Bicalutamide 150 mg is marketed in the EU following national and Mutual Recognition application procedures.
Maltese: Bicalutamide 150 mg tqiegħed fis-suq fl-UE wara proċeduri ta' applikazzjoni nazzjonali u ta' Rikonoxximent Reċiproku.
English: In view of the available data, the CHMP concluded that a potential association between the use of bicalutamide 150 mg and heart failure cannot be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
Maltese: Fid-dawl tad-dejta disponibbli, is-CHMP ikkonkluda li ma tistax tkun eskluża assoċjazzjoni potenzjali bejn bicalutamide 150 mg u l-falliment tal-qalb u għalhekk ikkonsidra l-ħtieġa ta' iktar studju dwar ilmortalità u l-morbidità kardjovaskulari għadha teżisti.
English: * Note: The information given in this document and Annexes reflect only the CHMP Opinion dated 24 May 2007.
Maltese: * Nota: It-tagħrif mogħti f'dan id-dokument u fl-Annessi jirriflettu biss l-Opinjoni tas-CHMP bid-data ta' l-24 ta' Mejju ta' l-2007 / L-awtoritajiet kompetenti ta' l-Istati Membri se jkomplu għaddejjin b'analiżi regolari tal-prodott.
English: • The need for intake of the 15 mg and 20 mg tablets with food
Maltese: • Il-ħtieġa għat-teħid tal-pilloli ta' 15 mg u 20 mg mal-ikel
English: • The MAH shall provide an educational pack, targeting all physicians who are expected to prescribe/use Xarelto prior to the launch of the new indication for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Maltese: • Id-Dententur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jipprovdi pakkett edukattiv immirat għat-tobba kollha li huma mistennija jiktbu/jużaw Xarelto qabel it-tendija tal-indikazzjoni il-ġdida għall-kura ta' ta' trombożi fil-vini l-fondi (DVT) u l-prevenzjoni ta' DVT rikorrenti u emboliżmu pulmonari (PE) wara
English: • The Prescriber Guide should contain the following key safety messages: Details of populations potentially at higher risk of bleeding Recommendations for dose reduction in at risk populations Guidance regarding switching from or to rivaroxaban treatment The need for intake of the 15 mg and 20 mg tablets with food Management of overdose situations The use of coagulation tests and their interpretation That all patients should be provided with a Patient alert card and be counselled about:
Maltese: Dettalji ta' popolazzjonijiet b'potenzjal akbar ta' riskju ta' fsada Rakkomandazzjonijiet għal tnaqqis fid-doża fil-popolazzjonijiet f'riskju Gwida dwar il-bidla minn jew għal kura b'rivoroxaban Il-ħtieġa għat-teħid tal-pilloli ta' 15 mg u 20 mg mal-ikel Immaniġġjar ta' sitwazzjonijiet ta' doża eċċessiva
English: • The MAH shall provide an educational pack, targeting all physicians who are expected to prescribe/use Xarelto prior to the launch of the new indication for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors.
Maltese: • Id-Dententur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jipprovdi pakkett edukattiv immirat għat-tobba kollha li huma mistennija jiktbu/jużaw Xarelto qabel it-tendija tal-indikazzjoni il-ġdida għall-kura ta' prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti adulti b'fibrillazzjoni talatriju mhux valvulari b'fattur ta' riskju wieħed jew aktar.
English: The need for intake of the 15 mg and 20 mg tablets with food Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals that they are taking Xarelto if they need to have any surgery or invasive procedure.
Maltese: Il-ħtieġa tat-teħid tal-pilloli ta' 15 mg u 20 mg mal-ikel Il-bżonn li l-Kartua ta' twissija għall-pazjent tinżamm magħhom kull ħin Il-ħtieġa li Professjonisti fil-Kura tas-Saħħa jiġu mgħarfa li qegħdin jieħdu rivoroxaban jekk ikunu jeħtieġu xi kirurġija jew xi proċedura invażiva.