FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon (may affect up to 1 in 100 people) - Problems with your heartbeat such as slow heartbeat - Seeing things that are not really there (hallucinations) - Stomach ulcer - Dehydration (losing too much fluid) - Hyperactivity (high level of activity, restlessness) - Aggression
Maltese: - Problemi fit-taħbit tal-qalb bħal taħbit tal-qalb bil-mod - Tara affarijiet li mhumiex qegħdin hemm (alluċinazzjonijiet) - Ulċera fl-istonku - Deidrazzjoni (titlef ħafna ilma) - Attività eċċessiva (livell għoli ta' attività, nuqqas ta' kwiet) - Aggressjoni
English: 7 transdermal patches 30 transdermal patches 60 transdermal patches 90 transdermal patches
Maltese: Garża waħda biss għandha tintlibes
English: Oral and topical repeated-dose toxicity studies in mice, rats, rabbits, dogs and minipigs revealed only effects associated with an exaggerated pharmacological action.
Maltese: Studji tat-tossiċità bid-doża ripetuta orali u dik mogħtija b'mod topiku li saru fuq firien, ġrieden, fniek, klieb u minipigs wrew biss effetti assoċjati ma' azzjoni farmakoloġika esaġerata.
English: How to apply your Rivastigmine 3M Health Care Ltd. transdermal patch Rivastigmine 3M Health Care Ltd. patches are transparent to translucent, plastic patches that stick to the skin.
Maltese: Rivastigmine 3M Health Care Ltd. jintuża għat-trattament ta' pazjenti adulti b'dimenzja ta' Alzheimer minn ħafifa sa moderata, disturb progressiv tal-moħħ li bil-mod il-mod jaffettwa lmemorja, l-ħila intellettwali u l-imġiba.
English: Isopropyl myristate
Maltese: Disturbi psikjatriċi Komuni
English: The percentages decreased in both rivastigmine 13.3 mg/24 h transdermal patch and rivastigmine 9.5 mg/24 h transdermal patch treatment groups over time (>24 weeks): application site erythema (0.8% vs. 1.6%) and application site pruritus (0.4% vs. 1.2%), respectively.
Maltese: Ilperċentwali naqsu matul iż-żmien (> 24 ġimgħa) kemm fil-grupp tal-garża Exelon li tipprovdi mediċina li tgħaddi minn ġol-ġilda 13.3 mg/24 siegħa kif ukoll fil-grupp tal-garża Exelon li tipprovdi mediċina li tgħaddi minn ġol-ġilda 9.5 mg/24 siegħa: eritema fis-sit tal-applikazzjoni (0.8% vs 1.6%) u ħakk fis-sit tal-applikazzjoni (0.4% vs 1.2%), rispettivament.
English: If you are pregnant, the benefits of using Rivastigmine 3M Health Care Ltd. transdermal patches must be assessed against the possible effects on your unborn child. Rivastigmine 3M Health Care Ltd. should not be used during pregnancy unless clearly necessary.
Maltese: Jekk ħriġt tqila, il-benefiċċji ta' Rivastigmine 3M Health Care Ltd. għandhom jiġu evalwati kontra leffetti li jista' jkun hemm fuq it-tarbija li għadha ma twelditx.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Rivastigmine 3M Health Care Ltd. is marketed, at launch and after launch of the transdermal patch all physicians who are expected to prescribe Rivastigmine 3M Health Care Ltd. are provided with an information pack containing the following elements:
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jara li, wara li jsiru ddiskussjonijiet u jintlaħaq il-ftehim mal-Awtoritajiet Kompetenti Nazzjonali f'kull Stat Membru fejn RIVASTIGMINE 3M HEALTH CARE LTD. jinsab għall-bejgħ, waqt it-tnedija u wara t-tnedija talgarża li tipprovdi mediċina li tgħaddi minn ġol-ġilda, it-tobba li huma mistennija li jippreskrivu RIVASTIGMINE 3M HEALTH
English: Very rare (may affect up to 1 in 10,000 people) - Stiff arms or legs - Trembling hands
Maltese: Rari ħafna (jista' jaffettwa sa persuna waħda minn kull 10,000)
English: Efficacy was established by the use of ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance-based measure of cognition) and the ADCS-IADL (Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living) assessing instrumental activities which include maintaining finances, meal preparation, shopping, ability to orient oneself to surroundings, ability to be left unattended.
Maltese: L-effikaċja ġiet stabbilita bl-użu tal-ADAS-Cog (Skala ta' Evalwazzjoni tal-Marda ta' Alzheimer - Sottoskala konjittiva, kejl tal-konjizzjoni ibbażata fuq ilħila) u l-ADCS-IADL (Studju Kooperattiv tal-Marda ta' Alzheimer - Attivitajiet Strumentali tal-Ħajja ta' Kuljum), li jevalwaw attivitajiet strumentali li jinkludu ż-żamma tal-finanzi, il-preparazzjoni talikel, ix-xirja, il-ħila li wieħed jorjenta ruħu għall-inħawi, il-ħila biex wieħed jitħalla waħdu.
English: INSTRUCTIONS ON USE
Maltese: Mhux magħruf
English: Care must be taken when prescribing Rivastigmine 3M Health Care Ltd. transdermal patches: - to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8) - to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8) - to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases.
Maltese: - lill-pazjenti b'sindrome ta' sinus marid jew difetti tal-konduzzjoni (imblukkar sinoatrijali, imblukkar atrijuventrikulari) (ara sezzjoni 4.8); - lill-pazjenti b'ulċeri attivi fl-istonku jew tad-duwodenu jew pazjenti li huma predisposti għal dawn il-kondizzjonijiet għaliex rivastigmine jista' jżid is-sekrezzjonijiet tal-istonku (ara sezzjoni 4.8); - lill-pazjenti li huma predisposti li jsofru minn imblukkar tal-awrina u aċċessjonijiet għaliex ilkolinomimetiċi jistgħu jikkawżaw jew jaggravaw dan il-mard; - lill-pazjenti li fil-passat sofrew bl-ażżma jew b'mard ostruttiv tal-pulmun.
English: Patients with clinically significant response (%)
Maltese: Pazjenti b'rispons klinikament rilevanti (%) Kapsuli Rivastigmine 12 mg/jum
English: Less than 1% of the administered dose is excreted in the faeces.
Maltese: Anqas minn 1% tad-doża mogħtija tneħħiet millġisem mal-ippurgar.
English: Package Leaflet: Information for the user Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Maltese: Rivastigmine 3M Health Care Ltd. 4.6 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda Rivastigmine 3M
English: Rectangular patches, approximately 2.5 cm by 1.8 cm with rounded corners.
Maltese: Garżi rettangolari, qies ta' madwar 2.5 ċm x 1.8 ċm b' kantunieri għat-tond.
English: Efficacy was established by the use of independent, domain-specific assessment tools which were applied at regular intervals during the 24-week treatment period.
Maltese: L-effikaċja kienet stabbilita permezz ta' għodod indipendenti li jevalwaw iddominju speċifiku li kienu applikati f'intervalli regolari waqt il-perjodu ta' 24 ġimgħa ta' kura.
English: 2 Based on CMH test (van Elteren test) blocking for country.
Maltese: 2 Ibbażat fuq l-eżami CMH (eżami van Elteren) li jimblokka għall-pajjiż.
English: ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward 1 Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
Maltese: ITT: Intenzjoni-Li-Tikkura; LOCF: L-Aħħar Osservazzjoni li Tmexxiet 'L Quddiem 1 Ibbażat fuq ANCOVA bil-kura u l-pajjiż bħala fatturi u valur fil-linja bażi bħala kovarjant.
English: United Kingdom Tel: +44 (0)1509 611611
Maltese: Sors: Studju D2340-Tabella 11-6 u Tabella 11-7
English: How to store Rivastigmine 3M Health Care Ltd.
Maltese: Kif gћandek tuża Rivastigmine 3M Health Care Ltd.
English: Transdermal use.
Maltese: Sintomi ekstrapiramidali
English: PHARMACOLOGICAL PROPERTIES
Maltese: IL-PRODOTT MEDIĊINALI
English: Transdermal patches
Maltese: Bradikardija
English: Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine patch (see section 4.4).
Maltese: Teżisti storja ta' reazzjonijiet fis-sit tal-applikazzjoni li jissuġġerixxu dermatite minħabba kuntatt allerġiku għall-garża ta' rivastigmine (ara sezzjoni 4.4).
English: Application site reactions were mostly mild to moderate in severity and were rated as severe in less than 2% of patients.
Maltese: Reazzjonijiet fis-sit tal-applikazzjoni kienu l-aktar ta' natura ħafifa għal moderata u ġew ikklassifikati bħala gravi f'inqas minn 2% tal-pazjenti.
English: - Fast or uneven heartbeat - High blood pressure - Fits (seizures) - Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite) - Changes in tests which show how well the liver is working - Feeling restless
Maltese: Ħakk, eritema, urtikarja, infafet, dermatite allerġika, reazzjonijiet mifruxin fuq il-ġilda minħabba sensittività eċċessiva Disturbi fil-kliewi u fis-sistema urinarja
English: Rivastigmine 9.5 mg/24 h N = 271
Maltese: ġilda Rivastigmine 9.5 mg/24 siegħa
English: The typical symptoms reported among these cases are similar to those seen with cases of overdose associated with rivastigmine oral formulations.
Maltese: Issintomi tipiċi rrapurtati fost dawn il-każijiet huma simili għal dawk osservati f'każijiet ta' doża eċċessiva assoċjata ma' formulazzjonijiet orali ta' rivastigmine.
English: The most commonly observed severe symptoms with rivastigmine 9.5 mg/24 h transdermal patches were pruritus (1.7%) and erythema (1.1%).
Maltese: L-aktar sintomi severi b'garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Rivastigmine 3M Health Care Ltd. 9.5 mg/24 siegħa kienu ħakk (1.7%) u ħmura (1.1%).
English: - Treatment usually starts with Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h. - The recommended daily dose is Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h (this high strength is currently not available from 3M but may be available from other Marketing
Maltese: Meta dożi ogħla minn 13.3 mg/24 siegħa ntużaw f'dan l-istudju kkontrollat bi plaċebo ta' hawn fuq, nuqqas ta' rqad u insuffiċjenza kardijaka dehru aktar ta' spiss milli bi 13.3 mg/24 siegħa jew plaċebo, li tindika li hemm relazzjoni mad-doża.
English: After oral administration, Cmax and AUC of rivastigmine were more than twice as high in Alzheimer patients with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in Alzheimer patients with severe renal impairment.
Maltese: Wara li jittieħed mill-ħalq, is-Cmax ta' rivastigmine kien aktar minn darbtejn ogħla f'pazjenti bil-marda ta' Alzheimer li kellhom indeboliment renali moderat meta dawn kienu mqabbla ma' individwi b'saħħithom; madankollu ma kien hemm l-ebda tibdiliet fis-Cmax u lAUC ta' rivastigmine f'pazjenti bil-marda ta' Alzheimer li kellhom indeboliment renali serju.
English: Release liner
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
English: As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Maltese: Bħala sustanza li tinibixxi cholinesterase, rivastigmine jista' jeżaġera l-effetti rilassanti tal-muskoli tattip succinylcholine waqt il-loppju.
English: In a 48-week active-controlled clinical trial, cases of skin irritation were captured as patient or caregiver reported adverse reactions.
Maltese: Fi prova klinika kkontrollata ta' 48 ġimgħa, każijiet ta' irritazzjoni tal-ġilda ġew identifikati bħala reazzjonijiet avversi rrappurtati mill-pazjenti jew minn min ikun qed jieħu ħsiebhom.
English: Each transdermal patch of 8.3 cm2 contains 14.33 mg of rivastigmine.
Maltese: 33 mg ta' rivastigmine.
English: Most skin reactions were limited to the application site and resulted in discontinuation in only 2.4% of the patients in the rivastigmine 9.5 mg/24 h transdermal patch group.
Maltese: Fil-parti lkbira, ir-reazzjonijiet tal-ġilda kienu limitati għas-sit mnejn ġiet applikata u wasslet għat-twaqqif fi 2.4% biss tal-grupp ta' kura tal-pazjenti b'garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda 9.5 mg/24 siegħa.
English: The full EPAR for Bonviva 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: This summary was last updated in 04-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'04-2016.
English: Bonviva ibandronic acid
Maltese: Bonviva aċidu ibandroniku
English: Other information about Bonviva
Maltese: Informazzjoni oħra dwar Bonviva
English: It is available as tablets (150 mg) and as a solution for injection in a prefilled syringe (3 mg).
Maltese: Jiġi bħala pilloli (150 mg) u bħala soluzzjoni għall-injezzjoni f'siringa diġà mimlija (3 mg).
English: The active substance in Bonviva, ibandronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Bonviva, l-aċidu ibandroniku, hija bisfosfonat.
English: This is a summary of the European public assessment report (EPAR) for Bonviva.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bonviva.
English: The most serious side effects with Bonviva are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), gastrointestinal (stomach and gut) irritation and eye inflammation.
Maltese: L-effetti sekondarji l-iktar serji b'Bonviva huma reazzjoni anafilattika (reazzjoni allerġika qawwija), ksur atipiku tal-wirk (tip mhux tassoltu tal-ksur tal-għadma tas-sieq ta' fuq), osteonekrożi tax-xedaq (ħsara lill-għadam tax-xedaq, li tista' twassal għal uġigħ, selħiet fil-ħalq jew laxkament tas-snien) irritazzjoni gastrointestinali (stonku u intestini) u infjammazzjoni fl-għajn.
English: The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5-mg once-daily tablets.
Maltese: Iż-żewġ studji l-oħra qabblu l-pilloli ta' 150 mg li jittieħdu darba fix-xahar (1,609 pazjenti) u l-injezzjonijiet (1,395 pazjent) mal-pilloli ta' 2.5 mg li jittieħdu kuljum.
English: Bonviva is a medicine that contains the active substance ibandronic acid.
Maltese: Bonviva huwa mediċina li fiha s-sustanza attiva aċidu ibandroniku.
English: Why has Bonviva been approved?
Maltese: Għaliex ġie approvat Bonviva?
English: The most common side effects with Bonviva (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms.
Maltese: L-effetti sekondarji l-iktar komuni bil-kura b'Bonviva (li dehru f'bejn pazjent 1 u 10 f'100) huma artralġja (uġiegħ fil-ġogi) u sintomi li jixbhu lil dawk tal-influwenza.
English: How has Bonviva been studied?
Maltese: Kif ġie studjat Bonviva?
English: In the first study, daily treatment with Bonviva 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
Maltese: Fl-ewwel studju, il-kura li saret kuljum b'Bonviva f'għamla ta' pilloli ta' 2.5 mg naqqset ir-riskju ta' ksur ġdid fis-sinsla tad-dahar b'62% apparagun mal-plaċebo.
English: What is Bonviva?
Maltese: X'inhu Bonviva?
English: What is the risk associated with Bonviva?
Maltese: X'inhu r-riskju assoċjat ma' Bonviva?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva on 23 February 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Bonviva valida fl-Unjoni Ewropea kollha fit-23 ta' Frar 2004.
English: In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.
Maltese: Fil-ġenbejn, id-densità tal-għadam żdiedet b'4% bil-pilloli li jittieħdu kull xahar u bi 3% bl-injezzjonijiet, apparagun ma' 2% bil-pilloli li jittieħdu kuljum.
English: A risk management plan has been developed to ensure that Bonviva is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Bonviva jintuża bl-aktar mod sigur possibbli.
English: (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.)
Maltese: (F'żoni fejn ikun hemm ilma aħrax, jiġifieri fejn l-ilma tal-vit ikun fih ħafna kaljċu maħlul, jista' jintuża ilma tal-flixkun b'kontenut minerali baxx.)
English: Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets.
Maltese: Matul sentejn, iddensità tal-għadam fis-sinsla tad-dahar żdiedet b'7% bil-pilloli li jittieħdu kull xahar u b'6% blinjezzjonijiet, apparagun ma' 5% bil-pilloli li jittieħdu kuljum.
English: What measures are being taken to ensure the safe and effective use of Bonviva?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Bonviva?
English: Bonviva has been studied in three main studies involving women with osteoporosis.
Maltese: Bonviva ġie studjat fi tliet studji ewlenin fuq nisa bl-osteoporożi.
English: In addition, the company that markets Bonviva will provide a card to inform patients receiving Bonviva infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Bonviva fis-suq ser tipprovdi kard biex tinforma lill-pazjenti bir-riskju ta' osteonekrożi tax-xedaq u tagħtihom parir jikkuntattjaw lit-tabib tagħhom jekk jesperjenzaw sintomi.
English: The first study compared Bonviva 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
Maltese: L-ewwel studju qabbel lil Bonviva f'għamla ta' pilloli ta' 2.5 mg li jittieħdu darba kuljum ma' plaċebo (kura finta) fi kważi 3,000 mara, u eżamina kemm deher ksur ġdid fis-sinsla tad-dahar tal-pazjenti tul tliet snin.
English: The other two studies showed that the 150-mg monthly tablets and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in the spine and the hip.
Maltese: Iż-żewġ studji l-oħra wrew li kemm il-pilloli ta' 150 mg li jittieħdu darba fix-xahar u kemm l-injezzjonijiet kienu iktar effikaċi mill-pilloli ta' 2.5 mg li jittieħdu kuljum fiż-żieda tad-densità tal-għadam tas-sinsla tad-dahar u tal-ġenbejn.
English: Bonviva is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Maltese: Bonviva jintuża fil-kura tal-osteoporożi (marda li ġġib l-għadam fraġli) fin-nisa li jkunu għaddew millmenopawża u li jkunu f'riskju li jiżviluppaw ksur fl-għadam.
English: The CHMP decided that Bonviva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Bonviva huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Bonviva must not be used in patients who have hypocalcaemia (low blood calcium levels).
Maltese: Bonviva ma għandux jintuża minn pazjenti li jbatu mill-ipokalċemija (livelli baxxi ta' kalċju fid-demm).
English: Julie Le Normand, France
Maltese: Julie Le Normand, Franza
English: John Crowley, Luxembourg
Maltese: John Crowley, il-Lussemburgu
English: Andrea Noya, Italy
Maltese: Andrea Noya, l-Italja
English: Notes
Maltese: Noti
English: Background
Maltese: Sfond
English: Jaroslaw Linka, Poland
Maltese: Jaroslaw Linka, il-Polonja
English: Comments were provided by Stephanie Fowler, Elizabeth Pyne (attending on behalf of her son), Deborah Kinrade and David Morison.
Maltese: Ġew ipprovduti kummenti minn Stephanie Fowler, Elizabeth Pyne (li attendiet f'isem binha), Deborah Kinrade u David Morison.
English: Enikő Pongrácz, Hungary
Maltese: Enikő Pongrácz, l-Ungerija
English: Neal L Millar, Institute of Infection, Immunity and Inflammation, University of Glasgow, UK Speaker 19:
Maltese: Neal L Millar, Istitut tal-Infezzjonijiet, Immunità u Infjammazzjoni, Università ta' Glasgow, ir-Renju Unit
English: Florian Wagenlehner, European Association of Urology (EAU) Additional interventions
Maltese: Florian Wagenlehner, Assoċjazzjoni Ewropea tal-Uroloġija (EAU) Interventi addizzjonali
English: Graham Bothamley, European Respiratory Society (ERS) Speaker 17:
Maltese: Graham Bothamley, Soċjetà Respiratorja Ewropea (ERS) Kelliem 17:
English: Manex Bettan Arguinzoniz, Spain Speaker 3:
Maltese: Manex Bettan Arguinzoniz, Spanja
English: The legal basis for public hearings is Article 107j of Directive 2001/83/EC of the pharmacovigilance legislation, which gives the PRAC the possibility to hold public hearings for safety reviews conducted by the Committee under Article 20 of Regulation (EC) No 726/2004, and Articles 31 or 107i of Directive 2001/83/EC.
Maltese: Il-bażi legali għas-seduti pubbliċi hija l-Artikolu 107j tad-Direttiva 2001/83/KE tal-leġiżlazzjoni talfarmakoviġilanza, li tagħti lill-PRAC il-possibbiltà li jorganizza seduti pubbliċi għal reviżjonijiet ta' sigurtà li jsiru mill-Kumitat skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, u l-Artikoli 31 jew 107i tad-Direttiva 2001/83/KE.
English: Jamie Wilkinson, Pharmaceutical Group of the European Union (PGEU) Speaker 16:
Maltese: Jamie Wilkinson, Grupp Farmaċewtiku tal-Unjoni Ewropea (PGEU) Kelliem 16:
English: Elizabeth Carmouche, Belgium
Maltese: Elizabeth Carmouche, il-Belġju
English: The hearing was chaired by June Raine, the Chair of the PRAC, with an introduction of the topic from by Eva Jirsová, the PRAC Rapporteur (lead assessor) and additional guidance from Juan Garcia-Burgos, EMA's Head of Public Engagement.
Maltese: Is-seduta ġiet ippreseduta minn June Raine, il-President tal-PRAC, b'introduzzjoni tas-suġġett minn Eva Jirsová, ir-Rapporteur tal-PRAC (valutatur ewlieni) u gwida addizzjonali minn Juan Garcia-Burgos, il-President tal-EMA tal-Ingaġġ Pubbliku.
English: 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Ġunju 2018 EMA/413844/2018
English: Questions addressed to participants
Maltese: Mistoqsijiet indirizzati lill-parteċipanti
English: Miriam Knight, Quinolone Toxicity Support UK Raymond Miller, Quinolone Toxicity Support UK Geoffrey Robinson, Fluoroquinolone Toxicity Victims in Europe Speaker 6:
Maltese: Miriam Knight, Appoġġ ta' Tossiċità b'Kinolon ir-Renju Unit Raymond Miller, Appoġġ ta' Tossiċità b'Kinolon ir-Renju Unit Geoffrey Robinson, Vittmi ta' Tossiċità bi Fluworokinolon fl-Ewropa Kelliem 6:
English: The most commonly used medicines in this class are ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.
Maltese: Il-mediċini li jintużaw bl-aktar mod komuni f'din il-klassi huma ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.
English: Proposals
Maltese: Proposti
English: Nigel Stacey provided comments after the video recording had been stopped.
Maltese: Nigel Stacey ipprovda kummenti wara li twaqqfet ir-reġistrazzjoni bil-vidjo.
English: Ber Oomen, European Specialist Nurses Organisations (ESNO) Speaker 20:
Maltese: Ber Oomen, Organizzazzjonijiet Ewropej ta' Infermiera Speċjalisti (ESNO) Kelliem 20:
English: Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics
Maltese: Sommarju tas-seduta pubblika tal-EMA dwar l-antibijotiċi kinolon u fluworokinolon
English: Richard Cooknell, UK
Maltese: Richard Cooknell, ir-Renju Unit
English: Paul Tulkens, Louvain Drug Research Institute, Belgium Speaker 21:
Maltese: Paul Tulkens, Istitut tar-Riċerka dwar il-Mediċini ta' Louvain, il-Belġju Kelliem 21: