FrancophonIA/ELRC3.0 huggingface dataset:
English: Blincyto is a medicine used to treat a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory).
Maltese: Blincyto huwa mediċina li tintuża biex tikkura kanċer tad-demm imsejjaħ lewkimja limfoblastika akuta (ALL) prekursura B f'pazjenti li jkollhom aktar minn sena meta l-kanċer ikun reġa' tfaċċa (rikadut) jew ma jkunx mar għall-aħjar b'kura preċedenti (refrattarju).
English: Blincyto has also been studied in a main study in 116 patients with minimal residual disease.
Maltese: Blincyto ġie studjat ukoll fi studju ewlieni f'116-il pazjent b'marda residwali minima.
English: The company that markets Blincyto will provide data from two studies looking at the safety and use of Blincyto in clinical practice.
Maltese: Il-kumpanija li tqiegħed Blincyto fis-suq sejra tipprovdi data minn żewġ studji li jħarsu lejn is-sigurtà u l-użu ta' Blincyto fil-prattika klinika.
English: How is Blincyto used?
Maltese: Kif jaħdem Blincyto?
English: What measures are being taken to ensure the safe and effective use of Blincyto?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Blincyto?
English: Active Substance
Maltese: Sustanza Attiva
English: Sweden Medical Valley Invest AB
Maltese: Medical Valley Invest AB
English: EBASTINE BIOGARAN ebastine
Maltese: EBASTINE BIOGARAN ebastina
English: EBASTINE ZENTIVA ebastine
Maltese: EBASTINE ZENTIVA ebastina
English: EBASTINE MYLAN ebastine
Maltese: EBASTINE MYLAN ebastina
English: Tablet
Maltese: TABLETS
English: Iceland Lyfis ehf.
Maltese: Lyfis ehf.
English: FarmozSociedade Técnico Medicinal, S.A.
Maltese: Sociedade Técnico Medicinal, S.A.
English: Germany Hexal Aktiengesellschaft
Maltese: Il-Ġermanja Hexal Aktiengesellschaft
English: Rasagilin Micro Labs 1 mg Tabletten rasagiline
Maltese: Rasagilin Micro Labs 1 mg Tabletten rasagilina
English: ebastine
Maltese: ebastina
English: amoxicillin mg
Maltese: amoksiċillina mg
English: Brown & Burk UK Limited
Maltese: Burk UK Limited
English: Amoxicilline Authou amoxicillin
Maltese: Amoxicilline Authou amoksiċillina
English: Teva PharmaProdutos Farmacêuticos, Lda.
Maltese: Teva Pharma - Produtos Farmacêutico s, Lda.
English: Saquinavir Accord 500 mg plėvele dengtos tabletės saquinavir
Maltese: Saquinavir Accord 500 mg plėvele dengtos tabletės sakinavir
English: Celecoxib Medical Valley celecoxib
Maltese: Celecoxib Medical Valley celecoksib
English: Celecoxib Hetero celecoxib
Maltese: Celecoxib Hetero celecoksib
English: Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras celecoxib
Maltese: Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras celecoksib
English: Bristol Laboratories Limited
Maltese: Ir-Renju Unit Bristol Laboratories Limited
English: Saquinavir HEXAL 500 mg Filmtabletten saquinavir
Maltese: Saquinavir HEXAL 500 mg Filmtabletten sakinavir
English: Saquinavir saquinavir
Maltese: Saquinavir sakinavir
English: Genepharm SA ERLOTINIB/GENEPHARM erlotinib
Maltese: ERLOTINIB/GENEPHARM erlotinib
English: Denmark Mylan AB
Maltese: Id-Danimarka Mylan AB
English: Denmark Sandoz A/S
Maltese: Id-Danimarka Sandoz A/S
English: Annex IB: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation
Maltese: Anness IB: Prodotti li għlihom l-awtorizzazzjonijiet għat-tqegħid fis-suq huma rrakkomandati għal sospensjoni u l-applikazzjonijiet għallawtorizzazzjoni għat-tqegħid fis-suq li ma jissidosfawx il-kriterji għall-awtorizzazzjoni
English: Finland Mylan AB
Maltese: Il-Finlandja Mylan AB
English: Finland Sandoz A/S
Maltese: Il-Finlandja Sandoz A/S
English: Saquinavir Accord 500 mg film-coated tablets saquinavir
Maltese: Saquinavir Accord 500 mg film-coated tablets sakinavir
English: 250MG/100MG FILMCOATED TABLETS
Maltese: 250MG/100MG FILMCOATED
English: Amoxicilina Brown amoxicillin
Maltese: Brown amoksiċillina
English: Erlotinib Vipharm 25 mg, 100 mg, 150 mg
Maltese: Vipharm S.A. Erlotinib Vipharm 25 mg, 100 mg, 150 mg
English: Germany Aristo Pharma GmbH
Maltese: Il-Ġermanja Aristo Pharma GmbH
English: Amoxicillin Micro Labs 1000 mg amoxicillin
Maltese: Amoxicillin Micro Labs 1000 mg amoksiċillina
English: Rasagiline Brown & Burk 1mg Tablets rasagiline
Maltese: Burk 1mg Tablets rasagilina
English: Medipha Sante AMOXICILLINE MEDIPHA 1 g amoxicillin
Maltese: MEDIPHA 1 g amoksiċillina
English: Denmark Orifarm Generics A/S
Maltese: In-Norveġja Orifarm Generics A/S
English: Celecoxib VIR 200 mg cápsulas duras EFG
Maltese: Celecoxib VIR 200 mg cápsulas duras
English: Amoxicillin Micro Labs 750 mg amoxicillin
Maltese: Amoxicillin Micro Labs 750 mg amoksiċillina
English: Sweden Orifarm Generics A/S
Maltese: Id-Danimarka Orifarm Generics A/S
English: Germany Hormosan Pharma
Maltese: Il-Ġermanja Hormosan Pharma Gesellschaft mit beschränkter
English: Saquinavir Farmoz saquinavir
Maltese: Saquinavir Farmoz sakinavir
English: 25 mg Capsule, hard Oral use
Maltese: 25 mg Kapsula, iebsa Użu orali
English: 20 mg Capsule
Maltese: 20 mg Kapsula
English: Abacavir/Lamivudine Rowex
Maltese: Abacavir/Lamivudin e Rowex
English: Irbesartan / Hydrochlorothiazide Micro Labs 300 mg /25 mg Filmtabletten irbesartan/ hydrochlorothiazide
Maltese: Irbesartan / Hydrochlorothiazide Micro Labs 300 mg /25 mg Filmtabletten irbesartan/ idroklorotijażid
English: Celecoxib
Maltese: celecoksib
English: Germany 1A Pharma GmbH
Maltese: Il-Ġermanja 1A Pharma GmbH
English: 60 mg Capsule
Maltese: 60 mg Kapsula
English: 30 mg Capsule
Maltese: 30 mg Kapsula
English: Hydrochlorothiazide Micro Labs 150 mg/12.5 mg Filmtabletten irbesartan/ hydrochlorothiazide
Maltese: Hydrochlorothiazide Micro Labs 150 mg/12.5 mg Filmtabletten irbesartan/ idroklorotijażid
English: Bulgaria
Maltese: l-Bulgarija
English: Amoxicillin Micro Labs 250 mg amoxicillin
Maltese: Amoxicillin Micro Labs 250 mg amoksiċillina
English: Industria Química Y Farmacéutica VIR, S.A.
Maltese: Industria Química Y Farmacéutica
English: Sweden Sandoz A/S
Maltese: Sandoz A/S
English: Celecoxib Glenmark 200 mg Hartkapseln celecoxib
Maltese: Celecoxib Glenmark 200 mg Hartkapseln celecoksib
English: Celecoxib Glenmark 100 mg Hartkapseln celecoxib
Maltese: Celecoxib Glenmark 100 mg Hartkapseln celecoksib
English: Celecoxib axcount 100 mg Hartkapseln celecoxib
Maltese: Celecoxib axcount 100 mg Hartkapseln celecoksib
English: Celecoxib axcount 200 mg Hartkapseln celecoxib
Maltese: Celecoxib axcount 200 mg Hartkapseln celecoksib
English: Erlotinib Vipharm 25 mg potahovane tablety
Maltese: Vipharm S.A. Erlotinib Vipharm 25 mg potahovane tablety
English: Amoxicillin Micro Labs 500 mg amoxicillin
Maltese: Amoxicillin Micro Labs 500 mg amoksiċillina
English: Erlotinib Vipharm 100 mg potahovane tablety
Maltese: Vipharm S.A. Erlotinib Vipharm 100 mg potahovane tablety
English: Hydrochlorothiazide Micro Labs 300 mg/12.5 mg Filmtabletten irbesartan/ hydrochlorothiazide
Maltese: Hydrochlorothiazide Micro Labs 300 mg/12.5 mg Filmtabletten irbesartan/ idroklorotijażid
English: Erlotinib Vipharm 150 mg potahovane tablety
Maltese: Vipharm S.A. Erlotinib Vipharm 150 mg potahovane tablety
English: Irbesartan/Hydrochlorot hiazide Brown & Burk 300mg/12.5mg Filmcoated tablets irbesartan/ hydrochlorothiazide
Maltese: Irbesartan/Hydrochlorot hiazide Brown & Burk 300mg/12.5mg Filmcoated tablets irbesartan/ idroklorotijażid
English: SAQUINAVIR SANDOZ saquinavir
Maltese: Saquinavir Sandoz sakinavir
English: Saquinavir Sandoz saquinavir
Maltese: SAQUINAVIR SANDOZ sakinavir
English: Irbesartan/Hydrochlorot hiazide Brown & Burk 300mg/25mg Filmcoated tablets irbesartan/ hydrochlorothiazide
Maltese: Irbesartan/Hydrochlorot hiazide Brown & Burk 300mg/25mg Filmcoated tablets irbesartan/ idroklorotijażid
English: Finland ratiopharm GmbH
Maltese: Il-Finlandja ratiopharm GmbH
English: 200 mg Capsule, hard Oral use
Maltese: 200 mg Kapsula, iebsa Użu orali
English: Abacavir/Lamivudine Hormosan 600 mg/300 mg Filmtabletten
Maltese: Abacavir/Lamivudin e Hormosan 600 mg/300 mg Filmtabletten
English: Denmark ratiopharm GmBH
Maltese: Id-Danimarka ratiopharm GmBH
English: Erlotinib Vipharm erlotinib
Maltese: Vipharm S.A. Erlotinib Vipharm erlotinib
English: 20 mg Capsule, hard Oral use
Maltese: 20 mg Kapsula, iebsa Użu orali
English: 60 mg Capsule, hard Oral use
Maltese: 60 mg Kapsula, iebsa Użu orali
English: ERLOTINIB VIPHARM 25 mg filmtabletta
Maltese: Vipharm S.A. ERLOTINIB VIPHARM 25 mg filmtabletta
English: ERLOTINIB VIPHARM 100 mg filmtabletta
Maltese: Vipharm S.A. ERLOTINIB VIPHARM 100 mg filmtabletta
English: Germany Glenmark Arzneimittel
Maltese: Għamla Farmaċewtika
English: 100 mg Capsule, hard Oral use
Maltese: 100 mg Kapsula, iebsa Użu orali
English: Saquinavir Accord saquinavir
Maltese: Saquinavir Accord sakinavir
English: 30 mg Capsule, hard Oral use
Maltese: 30 mg Kapsula, iebsa Użu orali
English: Sandoz Limited
Maltese: Ir-Renju Unit Sandoz Limited
English: Abacavir/Lamivudina Sandoz 600 mg/300 mg comprimimidos recubiertos con película EFG
Maltese: Abacavir/Lamivudin a Sandoz 600 mg/300 mg comprimimidos recubiertos con película EFG
English: ERLOTINIB VIPHARM 150 mg filmtabletta
Maltese: Vipharm S.A. ERLOTINIB VIPHARM 150 mg filmtabletta
English: Duloxetin-Hormosan 20 mg magensaftresistente Hartkapseln duloxetine
Maltese: Duloxetin-Hormosan 20 mg magensaftresistente Hartkapseln duloksetina
English: Duloxetine Lupin 60mg GR capsules duloxetine
Maltese: Duloxetine Lupin 60mg GR capsules duloksetina
English: Abacavir/Lamivudine Aristo
Maltese: Abacavir/Lamivudin e Aristo
English: 40 mg Capsule, hard Oral use
Maltese: 40 mg Kapsula, iebsa Użu orali
English: Duloxetine Lupin 20mg GR capsules duloxetine
Maltese: Duloxetine Lupin 20mg GR capsules duloksetina
English: Duloxetin-Hormosan 30 mg magensaftresistente Hartkapseln duloxetine
Maltese: Duloxetin-Hormosan 30 mg magensaftresistente Hartkapseln duloksetina
English: Duloxetine Lupin 30mg GR capsules duloxetine
Maltese: Duloxetine Lupin 30mg GR capsules duloksetina
English: Sandoz d.d.
Maltese: Il-Bulgarija Sandoz d.d.
English: Duloxetin-Hormosan 40 mg magensaftresistente Hartkapseln duloxetine
Maltese: Duloxetin-Hormosan 40 mg magensaftresistente Hartkapseln duloksetina
English: Abacavir/Lamivudina Aristo 600 mg/300 mg comprimidos recubiertos con película EFG
Maltese: Abacavir/Lamivudin a Aristo 600 mg/300 mg comprimidos recubiertos con película EFG
English: Abacavir/Lamivudina Amneal 600 mg/300 mg comprimidos recubiertos con película EFG
Maltese: Abacavir/Lamivudin a Amneal 600 mg/300 mg comprimidos recubiertos con película EFG
English: Abacavir/Lamivudine Lupin
Maltese: Abacavir/Lamivudin e Lupin
English: Duloxetine Lupin 40mg GR capsules duloxetine
Maltese: Duloxetine Lupin 40mg GR capsules duloksetina
English: Duloxetin-Hormosan 60 mg magensaftresistente Hartkapseln duloxetine
Maltese: Duloxetin-Hormosan 60 mg magensaftresistente Hartkapseln duloksetina
English: Abacavir/Lamivudina Mylan 600 mg/300 mg comprimidos recubiertos con película EFG
Maltese: Abacavir/Lamivudin a Mylan 600 mg/300 mg comprimidos recubiertos con película EFG
English: Abacavir / Lamivudine abacavir/ lamivudine
Maltese: Abacavir / Lamivudine
English: Pharmaceutica l Form
Maltese: Anness I
English: REPRAPOG 62.5 MG/25 MG FILM-COATED TABLETS
Maltese: MG/25 MG FILM-COATED TABLETS
English: Vipharm S.A.
Maltese: VIR, S.A.
English: Luxembour g ratiopharm GmbH
Maltese: IlLussemburgu ratiopharm GmbH
English: GmbH
Maltese: Farmoz
English: Strength
Maltese: Haftung
English: Str. Bega Nr. 4
Maltese: Bega Nr. 4
English: LABORATORIO Dr. ESTEVE, S.A.
Maltese: LABORATORIO Dr. ESTEVE, S.A. Avda.
English: S.C. BIO EEL S.R.L.
Maltese: BIO EEL S.R.L.
English: Târgu-Mureş 540390 România
Maltese: 540390 România
English: Depridol
Maltese: Târgu-Mureş
English: METADON BIOEEL
Maltese: METADON BIOEEL methadone
English: Alternova A/S Lodshusvej 11 4230 Skælskør Denmark
Maltese: Id-Danimarka Alternova A/S Lodshusvej 11
English: Metadon-EP 20 mg methadone
Maltese: Metadon-EP 20 mg tabletta
English: Metadon-EP 5 mg methadone
Maltese: Metadon-EP 5 mg tabletta
English: Bampton
Maltese: Bampton Road
English: Avda.
Maltese: Str.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for all authorised methadone medicinal products for oral use containing povidone
Maltese: Lista tal-ismijiet, għamla farmaċewtika (għamliet farmaċewtiċi), qawwa (qawwiet) tal-prodott(i) mediċinali, mnejn jingħata, id-detentur(i) ta` l-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: Martindale Pharmaceuticals Limited
Maltese: Martindale Pharmaceuticals
English: Martindale Pharmaceuticals Ltd.
Maltese: In-Norveġja Martindale Pharmaceuticals
English: Ref.: EMEA/356093/2009 EMEA/H/C/1031
Maltese: EMEA/484299/2009 EMEA/H/C/1031
English: Topotecan Actavis topotecan EPAR summary for the public
Maltese: Topotecan Actavis topotecan Sommarju tal-EPAR għall-pubbliku
English: It contains the active substance topotecan.
Maltese: Fih is-sustanza attiva topotecan.
English: The active substance in Topotecan Actavis, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Maltese: Is-sustanza attiva ta' Topotecan Actavis, topotecan, huwa mediċina kontra l-kanċer li tappartjeni għall-grupp tal-‘inibituri tat-topoisomerażi'.
English: It is used when giving the original treatment again is not recommended.
Maltese: No property name supplied.
English: What are the benefit and risk of Topotecan Actavis?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Topotecan Actavis?
English: It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Maltese: Timblokka enzima li tissejjaħ topoisomerażi I li hija involuta fid-duplikazzjoni tad-DNA.
English: This means that Topotecan Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Maltese: Topotecan Actavis huwa ‘mediċina ġenerika' li jfisser li Topotecan Actavis huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Hycamtin.
English: What is Topotecan Actavis?
Maltese: Kif jaħdem Topotecan Actavis?
English: Treatment may continue until the disease gets worse.
Maltese: It-trattament jista' jitkompla sa ma taggrava lmarda.
English: The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Actavis to Actavis Group PTC ehf.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Topotecan Actavis lil Actavis Group PTC ehf. fi 24 ta' Lulju 2009.
English: Why has Topotecan Actavis been approved?
Maltese: Għaliex ġie approvat Topotecan Actavis?
English: Other information about Topotecan Actavis:
Maltese: Aktar tagħrif dwar Topotecan Actavis:
English: How has Topotecan Actavis been studied?
Maltese: Kif ġie studjat Topotecan Actavis?
English: Because Topotecan Actavis is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Topotecan Actavis huwa mediċina ġenerika, il-benefiċċju u r-riskju tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: When used with cisplatin in cervical cancer, Topotecan Actavis is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Maltese: Topotecan Actavis, meta użat maċ-ċisplatinu fil-kanċer tal-għonq tal-utru, jingħata bħala infużjoni filjiem nru 1, 2 u 3 (biċ-ċisplatinu jingħata fil-jum 1).
English: No additional studies were needed as Topotecan Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali billi Topotecan Actavis huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attivi bħal dik tal-mediċina ta' referenza, Hycamtin.
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Maltese: Jintuża wkoll flimkien maċ-ċisplatinu (cisplatin - mediċina oħra kontra l-kanċer) fit-trattament ta' nisa bil-kanċer tal-għonq tal-utru (ċerviċi), f'każ ta' kanċer reċidiv wara r-radjoterapija jew fil-każ meta lmarda tkun fi stadju avvanzat (stadju IVB: il-kanċer ikun infirex lil hinn miċ-ċerviċi).
English: Because Topotecan Actavis is a generic medicine, the company has provided data from the published literature on topotecan.
Maltese: Billi Topotecan Actavis huwa mediċina ġenerika, il-kumpanija ppovdiet tagħrif mil-letteratura ppubblikata dwar topotecan.
English: The patient's blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, to ensure that they are above set minimum levels.
Maltese: Il-livelli tad-demm tal-pazjent taċ-ċelloli bojod tad-demm, tal-platelets u tal-emoglobina għandhom ikunu kkontrollati qabel it-trattament biex ikun aċċertat li jkunu ogħla mil-livelli minimi stabbiliti.
English: Topotecan Actavis is a powder to be made up into a solution for infusion (drip into a vein).
Maltese: Topotecan Actavis huwa trab biex jinħall f'soluzzjoni għall-infużjoni (dripp fil-vina).
English: 12 January 2016 EMA/788882/2015
Maltese: EMA/788882/2015
English: It contains antigens for types 16 and 18 of the virus.
Maltese: Fih antiġeni għat-tipi 16 u 18 tal-virus.
English: 1 Donegan K, et al. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK.
Maltese: Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK.
English: Vaccine
Maltese: Tel.
English: It contains antigens (proteins that help product antibodies) against 4 types of HPV (types 6, 11, 16 and 18).
Maltese: Fih antiġeni (proteini li jgħinu lill-antikopri tal-prodott) kontra 4 tipi ta' HPV (tipi 6, 11, 16 u 18).
English: The final stage of the review procedure was the adoption by the European Commission of a legally binding decision applicable in all EU Member States on 12/01/2016.
Maltese: L-istadju finali tal-proċedura ta' reviżjoni kien l-adozzjoni mill-Kummissjoni Ewropea ta' deċiżjoni li torbot legalment applikabbli flIstati Membri tal-UE kollha fi 12/01/2016.
English: HPV vaccines are available in the European Union under the names Gardasil/Silgard, Gardasil 9, and Cervarix.
Maltese: Il-vaċċini tal-HPV huma disponibbli fl-Unjoni Ewropea bl-ismijiet Gardasil/Silgard, Gardasil 9, u Cervarix.
English: On 19 November EMA completed its review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines.
Maltese: Fid-19 ta' Novembru, l-EMA lestiet ir-reviżjoni tal-evidenza relatata mar-rapporti taż-żewġ sindromi, issindrome ta' uġigħ reġjonali kumpless (CRPS) u s-sindrome ta' takikardija ortostatika posturali (POTS) f'nisa żgħażagħ li ngħataw vaċċini tal-papillomavirus uman (HPV).
English: Gardasil 9 (approved in June 2015) is used similarly but contains antigens for 9 types of the virus (types 6, 11, 16, 18, 31, 33, 45, 52 and 58).
Maltese: Gardasil 9 (approvat f'Ġunju 2015) jintuża b'mod simili iżda fih antiġeni għal 9 tipi tal-virus (tipi 6, 11, 16, 18, 31, 33, 45, 52 u 58). Cervarix ilu approvat minn Settembru 2007 għall-użu fin-nisa u l-bniet għal protezzjoni kontra tkabbir ta' qabel il-kanċer fiċ-ċerviċi u l-parti ġenitali.
English: The review of HPV vaccines was initiated on 9 July 2015 by the European Commission at the request of Denmark, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni tal-vaċċini tal-HPV inbdiet fid-9 ta' Lulju 2015 mill-Kummissjoni Ewropea fuq talba midDanimarka, skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom account detailed information received from a number of patient groups that also highlighted the impact these syndromes can have on patients and families.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The Agency's Pharmacovigilance Risk Assessment Committee (PRAC) was responsible for the initial review.
Maltese: Il-Kumitat tal-Evalwazzjoni tar-Riskju fil-qasam tal-Farmakoviġilanza (PRAC) tal-Aġenzija kien responsabbli għar-reviżjoni inizjali.
English: It is estimated that more than 63 million girls and women worldwide have been vaccinated with Gardasil/Silgard and more than 19 million with Cervarix.
Maltese: Huwa stmat li iktar minn 63 miljun tifla u mara madwar id-dinja tlaqqmu b'Gardasil/Silgard u iktar minn 19-il miljun b'Cervarix.
English: • CRPS (chronic regional pain syndrome) is defined as continuing pain that is disproportionate to the inciting event (typically an episode of trauma or limb immobilisation), and is associated with sensory, sudomotor, motor and dystrophic changes.
Maltese: • Is-CRPS (sindrome ta' uġigħ reġjonali kroniku) hija definita bħala uġigħ kontinwu li mhuwiex proporzjonat mal-avveniment ta' inċitament (ġeneralment episodju ta' trawma jew immobilizzazzjoni ta' driegħ/riġel), u hija assoċjata ma' tibdil fis-sensi, sudomotorji, motorji u distrofiċi.
English: Gardasil has been authorised since September 2006, and is approved for use in males and females for preventing precancerous growths and cancer in the cervix and anus, and genital warts.
Maltese: Gardasil ilu awtorizzat minn Settembru 2006, u huwa approvat għal użu fl-irġiel u n-nisa għall-prevenzjoni ta' tkabbir ta' qabel il-kanċer u kanċer fil-ċerviċi u l-anus, u felul ġenitali.
English: The above recommendations are based on analyses of clinical trial and post-marketing data and included review of published literature, spontaneous reports of suspected adverse effects, reports submitted by Member States as well as information from other countries, and information submitted voluntarily by the public.
Maltese: Ir-rakkomandazzjonijiet imsemmija hawn fuq huma bbażati fuq analiżijiet tal-provi kliniċi u d-data ta' wara t-tqegħid fis-suq u inkludew reviżjoni ta' dokumentazzjoni ppubblikata, rapporti spontanji ta' effetti avversi suspettati, rapporti sottomessi mill-Istati Membri kif ukoll informazzjoni minn pajjiżi oħrajn, u informazzjoni sottomessa b'mod volontarju mill-pubbliku.
English: These are accompanied by symptoms (e.g. light-headedness, syncope, weakness, headaches, chronic aches and pains, gastrointestinal symptoms and fatigue) which differ between patients.
Maltese: Dawn huma akkumpanjati minn sintomi (eż. mejt, sinkope, dgħjufija, uġigħ ta' ras, uġigħ kroniku, sintomi gastrointestinali u għeja) li jvarjaw bejn il-pazjenti.
English: The Agency also consulted a group of experts in these syndromes and in neurology, cardiology and pharmacoepidemiology.
Maltese: L-Aġenzija kkonsultat ukoll grupp ta' esperti f'dawn is-sindromi u fin-newroloġija, il-kardjoloġija u l-farmakoepidemjoloġija.
English: • A careful review looking at the available evidence has concluded that the occurrence of CRPS and POTS in vaccinated girls is no higher than would be expected in girls in the general population (around 150 cases of CRPS and at least 150 of POTS per million each year), and that there is no evidence that the vaccines can trigger these syndromes.
Maltese: • Reviżjoni bir-reqqa li teżamina l-evidenza disponibbli kkonkludiet li l-okkorrenza ta' CRPS u POTS fi bniet imlaqqmin mhijiex ogħla milli jkun mistenni fi bniet fil-popolazzjoni ġenerali (madwar 150 każ ta' CRPS u tal-inqas 150 ta' POTS għal kull miljun kull sena), u li m'hemm ebda evidenza li l-vaċċini jistgħu jiskattaw dawn is-sintomi.
English: • Available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year and at least 150 girls and young women per million may develop POTS each year.
Maltese: • L-istimi disponibbli jissuġġerixxu li fil-popolazzjoni ġenerali madwar 150 tifla u tfajla minn kull miljun li għandhom bejn 10 u 19-il sena jistgħu jiżviluppaw CRPS kull sena, u tal-inqas 150 tifla u tfajla minn kull miljun jistgħu jiżviluppaw POTS kull sena.