FrancophonIA/ELRC3.0 huggingface dataset:
English: The ANDROMEDA study was conducted in 627 patients with left ventricular dysfunction, hospitalised with new or worsening heart failure and who had had at least one episode of shortness of breath on minimal exertion or at rest (NYHA class III or IV) or paroxysmal nocturnal dyspnoea within the month before admission.
Danish: indlagt med ny eller forværret hjerteinsufficiens og som havde haft mindst ét tilfælde af stakåndethed under minimal fysisk anstrengelse, eller under hvile (NYHA klasse III eller IV), eller som havde haft mindst et tilfælde af paroksystisk natlig dyspnø inden for en måned inden indlæggelsen.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (forekommer hos flere end 1 patient ud af 10)
English: • Opaque PVC/Aluminium blister in packs of 20, 50 and 60 film-coated tablets • Opaque PVC/Aluminium perforated unit dose blister in packs of 100x1 film-coated tablets.
Danish: • Uigennemsigtige PVC/aluminium perforerede enhedsdosis-blister i pakninger af 100x1 filmovertrukne tabletter.
English: Maintenance of sinus rhythm
Danish: Vedligeholdelse af sinusrytme
English: The effect of severe hepatic impairment on the pharmacokinetics of dronedarone was not assessed (see section 4.3).
Danish: Effekten af svært nedsat leverfunktion på dronedarons farmakokinetik er ikke fastlagt (se pkt.
English: Therefore, co-administration of rifampicin and other potent CYP 3A4 inducers such as phenobarbital, carbamazepine, phenytoin or St John's Wort is not recommended as they decrease dronedarone exposure.
Danish: Derfor frarådes samtidig administration af rifampicin og andre potente CYP3A4-induktorer såsom phenobarbital, carbamazepin, phenytoin eller perikon, da de vil nedsætte plasmakoncentrationen af dronedaron.
English: Patients should be appropriately anti-coagulated as per clinical AF guidelines.
Danish: Vitamin K antagonister Patienterne skal antikoagulansbehandles relevant i henhold til kliniske retningslinjer for AF.
English: Cases of CHF have also been reported in post-marketing experience (frequency not known) (see section 4.4).
Danish: Der er også indrapporteret tilfælde af kongestiv hjerteinsufficiens post-marketing (ikke kendt frekvens) (se pkt.
English: These medicinal products should be initiated at low dose and up titration should be done only after ECG assessment.
Danish: Behandling med disse lægemidler bør påbegyndes ved lav dosis, og optitrering bør kun ske efter vurdering af ekg.
English: Interaction with warfarin and losartan (CYP 2C9 substrates) Warfarin and other vitamin K antagonists
Danish: Interaktion med warfarin og losartan (CYP2C9-substrater)
English: Dronedarone is contraindicated in patients in unstable hemodynamic conditions, with history of, or current heart failure or left ventricular systolic dysfunction (see section 4.3).
Danish: Dronedaron er kontraindiceret hos patienter i ustabil hæmodynamisk tilstand og med en anamnese med hjerteinsufficiens eller systolisk dysfunktion af venstre ventrikel (se pkt.
English: Also contains: lactose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også: Lactose.
English: Common (1/100 to
Danish: Almindelig (≥ 1/100 to < 1/10)
English: Potent CYP 3A4 inhibitors
Danish: Potente CYP3A4-inhibitorer
English: If heart failure develops, treatment with dronedarone should be discontinued.
Danish: Hvis hjerteinsufficiens udvikles, skal dronedaron seponeres.
English: • skin problems such as rash or itching,
Danish: • hudproblemer såsom udslæt eller kløe,
English: Therefore, inhibitors and inducers of CYP 3A4 have the potential to interact on dronedarone.
Danish: Derfor kan CYP3A4-inhibitorer oginduktorer potentielt interagere med dronedaron.
English: Dronedarone does not affect the pharmacokinetics of omeprazole, a CYP 2C19 substrate.
Danish: Interaktion med omeprazol (CYP2C19-substrat) Dronedaron påvirker ikke omeprazols farmakokinetik (et CYP2C19-substrat).
English: It should be taken as:
Danish: Denne dosis bør tages som
English: If left ventricular systolic dysfunction develops, treatment with dronedarone should be discontinued.
Danish: Hvis der udvikles systolisk dysfunktion af venstre ventrikel, skal dronedaron seponeres.
English: Four thousand six hundred and twenty eight (4,628) patients were randomised and treated for up to 30 months maximum (median follow-up: 22 months) with either dronedarone 400 mg twice daily (2,301 patients) or placebo (2,327 patients), in addition to conventional therapy including beta-blockers (71%), ACE inhibitors or AIIRAs (69%) digitalis (14%), calcium antagonists (14%), statins (39%), oral anticoagulants (60%), chronic antiplatelet therapy (6%) and/or diuretics (54%).
Danish: 4628 patienter blev randomiseret og behandlet i op til maksimalt 30 måneder (median opfølgning: 22 måneder) med enten dronedaron 400 mg to gange daglig (2301 patienter) eller placebo (2327 patienter), ud over konventionel behandling inklusive betablokkere (71 %), ACE-hæmmere eller AIIRA'er (69 %),
English: • tell your doctor immediately if you develop any of these signs and symptoms of liver problems: stomach (abdominal) area pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching,
Danish: • hvis du udvikler nedenstående tegn og symptomer på leverproblemer, skal du straks fortælle det til din læge: smerter i maveregionen eller ubehag, appetitløshed, kvalme, opkastning, gulfarvning af huden eller det hvide i øjnene (gulsot), usædvanlig mørkfarvning af urinen, træthed (særligt i forbindelse med andre symptomer anført ovenfor), kløe,
English: Potent CYP3A4 inducers
Danish: Potent CYP3A4-induktorer
English: Dronedarone is contraindicated in patients with severe hepatic impairment because of the absence of data (see sections 4.3 and 4.4).
Danish: Dronedaron er kontraindiceret hos patienter med alvorlig leverinsufficiens på grund af mangel på dokumentation (se pkt.
English: Interaction with medicinal products metabolized by CYP 3A4 Dabigatran
Danish: Interaktion med lægemidler, der metaboliseres af CYP3A4
English: 4.7 Effects on ability to drive and use machines MULTAQ has no or negligible influence on the ability to drive and use machines.
Danish: MULTAQ påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: MULTAQ contains lactose
Danish: MULTAQ indeholder lactose
English: MULTAQ 400 mg film-coated tablets dronedarone
Danish: MULTAQ 400 mg filmovertrukne tabletter dronedaron
English: Dronedarone 400 mg twice daily does not increase the steady state theophylline exposure.
Danish: Interaktion med theofyllin (CYP1A2-substrat) Dronedaron 400 mg to gange daglig medførte ikke en stigning i steady-state theofyllinplasmakoncentrationen.
English: Lactose monohydrate Colloidal anhydrous silica Magnesium stearate (E572)
Danish: Magnesiumstearat (E572)
English: Sotalol must be stopped before starting dronedarone (see sections 4.2 and 4.3).
Danish: Sotalol skal seponeres før opstart af dronedaron (se pkt.
English: Dronedarone is primarily metabolised by CYP 3A4 (see section 5.2).
Danish: Dronedaron bliver metaboliseret primært af CYP3A4 (se pkt.
English: CYP 3A4 inducers
Danish: CYP3A4-induktorer
English: In 2-year oral carcinogenicity studies, the highest dronedarone dose administered for 24 months was 70 mg/kg/day in rats and 300 mg/kg/day in mice.
Danish: 70 mg/kg/dag i rotter, og 300 mg/kg/dag i mus.
English: Grapefruit juice should not be taken together with to dronedarone (see section 4.5).
Danish: Dronedaron bør ikke tages sammen med grapefrugtjuice (se pkt.
English: Titanium dioxide (E171) Carnauba wax (E903)
Danish: Carnaubavoks (E903)
English: Reduction of risk of AF-related hospitalisation
Danish: Nedsættelse af risiko for AF-relateret indlæggelse Effekten af dronedaron på reduktion af risiko for AF-relateret indlæggelse blev demonstreret hos patienter,
English: Signs include breathlessness or non-productive cough.
Danish: Symptomer inkluderer åndenød eller tør hoste.
English: How to take MULTAQ
Danish: Sådan skal du tage MULTAQ
English: Forty seven percent (47%) of patients were female and a majority was Caucasian (89%).
Danish: 47 % af patienterne var kvinder,
English: Treatment with dronedarone should be stopped during the course of treatment, in case the patient develops any of the conditions which would lead to a contraindication as mentioned in section 4.3.
Danish: Dronedaron bør seponeres, hvis patienten udvikler nogle af de kontraindicerede tilstande (se pkt.
English: In such cases dronedarone should be stopped (see sections 4.3 and 4.4).
Danish: I sådanne tilfælde skal dronedaron seponeres (se pkt.
English: Dronedarone was not shown to alter fertility in animal studies.
Danish: Dyreforsøg har ikke påvist, at dronedaron påvirker fertiliteten.
English: Liver function
Danish: Nedsat leverfunktion
English: • Co-administration with potent cytochrome P 450 (CYP) 3A4 inhibitors, such as ketoconazole,
Danish: • Co-administration med potente CYP3A4-inhibitorer såsom ketoconazol, itraconazol, voriconazol,
English: Dronedarone (600 mg twice daily) increased by 1.2-fold S-warfarin with no change in R-warfarin and only a 1.07 increase in International Normalised Ratio (INR).
Danish: Warfarin og andre vitamin K-antagonister Dronedaron (600 mg to gange daglig) forøgede niveauet af S-warfarin 1,2 gange uden ændring i R-warfarin,
English: • History of, or current heart failure or left ventricular systolic dysfunction
Danish: • Anamnese med hjerteinsufficiens eller systolisk dysfunktion af venstre ventrikel
English: In patients ≥75years old, clinical signs of heart failure and ECG should be monitored on a regular basis when co-morbidities are present (see sections 4.3, 4.4 and 5.1).
Danish: Hos patienter ≥75 år, skal kliniske tegn på hjertesinsufficiens og EKG overvåges regelmæssigt hvis der foreligger komorbiditeter (se pkt.
English: NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg tablets dronedarone
Danish: LÆGEMIDLETS NAVN MULTAQ 400 mg tabletter dronedaron
English: Electrolytes imbalance
Danish: Elektrolytforstyrrelser
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
Danish: Indehaver af markedsføringstilladelsen sanofi-aventis groupe 54, rue La Boétie
English: NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN MULTAQ 400 mg filmovertrukne tabletter
English: No dose adjustment is required in other patients with renal impairment (see sections 4.4 and 5.2).
Danish: Dosisjustering er ikke nødvendigt hos andre patienter med nedsat nyrefunktion (se pkt.
English: Patients with history of, or current heart failure or left ventricular systolic dysfunction
Danish: Patienter med en anamnese med hjerteinsufficiens eller systolisk dysfunktion af venstre ventrikel
English: Liver injury
Danish: Leverskader
English: In patients already taking beta-blockers at time of dronedarone initiation, an ECG should be performed and the dose of beta-blocker should be adjusted if needed (see section 4.4).
Danish: Hos patienter som allerede er i behandling med beta-blokkere på det tidspunkt at dronedaronbehandlingen initieres, skal et EKG udføres og doseringen af beta-blokkere bør justeres hvis nødvendigt (se pkt.
English: Sanofi S.p.A Tel: +39 02 39394275
Danish: Tel: +39 02 39394275
English: • Patients in unstable hemodynamic conditions
Danish: • Ustabil hæmodynamisk tilstand
English: Pharmacodynamic properties
Danish: Farmakodynamisk virkning
English: Ageusia
Danish: Ageusi
English: Although plasma exposure in elderly females was increased in a pharmacokinetic study conducted in healthy subjects, dose adjustments are not considered necessary (see sections 5.1 and 5.2).
Danish: 4.3, 4.4 og 5.1) Dosisjustering anses ikke for nødvendig, selvom et farmakokinetisk studie udført med raske individer viste øget plasmakoncentration hos ældre kvinder (se pkt.
English: • some medicines for reducing the cholesterol in your blood (such as simvastatin, lovastatin,
Danish: • visse typer kolesterolsænkende medicin (såsom simvastatin, lovastatin, atorvastatin eller rosuvastatin),
English: Moderate/weak CYP 3A4 inhibitors
Danish: Moderate/svage CYP3A4-inhibitorer: Calciumantagonister
English: In elderly patients ≥75 years with multiple co-morbidities, clinical signs of heart failure and ECG should be monitored on a regular basis (see sections 4.2 and 5.1).
Danish: Hos ældre patienter ≥75 år med multiple komorbiditeter skal kliniske tegn på hjerteinsufficiens og EKG
English: Moreover, due to their heart rate-lowering properties, verapamil and diltiazem have the potential to interact with dronedarone from a pharmacodynamic point of view.
Danish: Desuden kan verapamil og diltiazem ud fra et farmakodynamisk synspunkt potentielt interagere med dronedaron, på grund af deres evne til at nedsætte hjertefrekvensen.
English: Uncommon (1/1,000 to
Danish: Ikke almindelig (≥ 1/1.000 to < 1/100)
English: Monitoring of their plasma concentrations and appropriate dose adjustment is recommended in case of coadministration with dronedarone.
Danish: Ved administration sammen med dronedaron anbefales monitorering af disse stoffers plasmakoncentration og passende dosisjustering.
English: Losartan and other Angiotensin II Receptor Antagonists (AIIRAs)
Danish: ACE eller AII receptor-antagonister Ja
English: Screen patients before treatment initiation Contra indication of Permanent Atrial fibrillation Contra indication of history, or current heart failure or left ventricular systolic dysfunction (LVSD)
Danish: • Screening af patienter før behandlingsstart - kontra indikation ved permanent atrieflimmer - kontra indikation ved tidligere eller nuværende hjertesvigt eller venstre ventrikel systolisk dysfunktion (LVSD) - forebyggelse af lægemiddelinteraktioner - lever, lunge og renal sikkerhed ved anvendelse.
English: Bradycardia (see sections 4.3 and
Danish: Bradykardi (se pkt.
English: Blood creatinine increased* QTc Bazett prolonged # * ≥10% five days after treatment initiation (see section 4.4) # >450 msec in male >470 msec in female (see section 4.4) Description of selected adverse reactions
Danish: 4.4) # > 450 millisekunder for mænd, > 470 millisekunder for kvinder (se pkt.
English: Fatigue Asthenia
Danish: Opkastning Kvalme
English: NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg film-coated tablets dronedarone
Danish: LÆGEMIDLETS NAVN MULTAQ 400 mg filmovertrukne tabletter dronedaron
English: 100x1 film-coated tablets
Danish: 20 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 100x1 filmovertrukne tabletter
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjælden (forekommer hos 1 til 10 patienter ud af 10.000)
English: Uncommon (may affect up to 1 in 100 people)
Danish: Almindelig (forekommer hos 1 til 10 patienter ud af 100)
English: What MULTAQ is and what it is used for What you need to know before you take MULTAQ How to take MULTAQ
Danish: Det skal du vide, før du begynder at tage MULTAQ Sådan skal du tage MULTAQ Bivirkninger
English: Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Danish: Tel: +40 (0) 21 317 31 36
English: In patients already on calcium antagonists at time of dronedarone initiation, an ECG should be performed and the calcium antagonist dose should be adjusted if needed (see section 4.4).
Danish: Hos patienter, der allerede er i behandling med calciumantagonister på det tidspunkt, hvor dronedaronbehandling påbegyndes, bør der udføres ekg, og calciumantagonist-dosis bør justeres om nødvendigt (se pkt.
English: The efficacy of dronedarone in the reduction of risk of AF-related hospitalisation was demonstrated in patients with AF or a history of AF and additional risk factors in the ATHENA multicenter, multinational, double blind, and randomised placebo-controlled study.
Danish: der havde eller tidligere havde haft AF med yderligere risikofaktorer i ATHENA, der er et multicenter-,
English: In patients already on calcium antagonists or beta blockers at time of dronedarone initiation, an ECG should be performed and the dose should be adjusted if needed.
Danish: Der bør tages ekg på patienter i behandling med calciumantagonister eller betablokkere, når dronedaron initieres, og dosis bør om nødvendigt justeres.
English: MULTAQ 400 mg
Danish: INFORMATION I BRAILLESKRIFT MULTAQ 400 mg
English: In patients already taking beta-blockers at time of dronedarone initiation, an ECG should be performed and the betablocker dose should be adjusted if needed (see section 4.4).
Danish: Hos patienter der allerede er i behandling med betablokkere ved påbegyndelse af behandling med dronedaron, bør der udføres ekg, og dosis af betablokkeren bør justeres om nødvendigt (se pkt.
English: tricyclic antidepressants, terfenadine and certain oral macrolides (such as erythromycin), Class I
Danish: • Lægemidler, der inducerer torsades de pointes såsom phenothiaziner, cisaprid, bepridil, tricykliske antidepressiva, terfenadin og visse orale makrolider såsom erythromycin, antiarytmika af klasse I og
English: If you take more MULTAQ than you should
Danish: Hvis du har taget for meget MULTAQ
English: Renal impairment
Danish: Træthed Asteni
English: France sanofi-aventis France
Danish: Eesti sanofi-aventis Estonia OÜ
English: Tablet coat
Danish: Calciumantagonister
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN sanofi-aventis groupe
English: • St John's Wort - a herbal medicine for depression,
Danish: • perikon - naturlægemiddel mod depression,
English: The active substance is dronedarone.
Danish: MULTAQ indeholder: - Aktivt stof: dronedaron.
English: Danmark Sanofi A/S Tlf: +45 45 16 70 00
Danish: Tlf.: +45 45 16 70 00
English: Beta-blockers that are metabolised by CYP 2D6 can have their exposure increased by dronedarone.
Danish: Dronedaron kan øge plasmakoncentrationen af betablokkere, der metaboliseres af CYP2D6.
English: Each tablet also contains 41.65 mg of lactose (as monohydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 400 mg dronedaron (som hydrochlorid) Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 41,65 mg lactose (som monohydrat) Alle hjælpestoffer er anført under pkt.
English: MULTAQ.
Danish: Mand
English: Moreover, beta-blockers have the potential to interact with dronedarone from a pharmacodynamic point of view.
Danish: Fra et farmakodynamisk synspunkt kan betablokkere desuden potentielt interagere med dronedaron.
English: Sanofi S.p.A. Tel: 800.536389
Danish: Tel: 800.536 389
English: Tél: 0 800 222 555
Danish: France sanofi-aventis France Tél: 0 800 222 555
English: In subjects with moderate hepatic impairment, dronedarone unbound exposure is increased by 2-fold.
Danish: Plasmakoncentrationen af ubundet dronedraron var fordoblet hos forsøgspersoner med moderat nedsat leverfunktion.
English: • Problem where your heart does not adequately pump the blood round your body as well as it should (congestive heart failure) In clinical studies, this side effect was observed at a similar rate in patients receiving MULTAQ and in patients receiving placebo.
Danish: I kliniske studier blev denne bivirkning set med samme hyppighed hos de patienter, der fik MULTAQ, og de patienter, der fik uvirksom medicin (placebo).
English: System organ class
Danish: Tabel 1: Bivirkninger Systemorganklasse Meget almindelig
English: PHARMACEUTICAL FORM AND CONTENTS 20 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: Tablet core
Danish: Mave-tarm-kanalen
English: Malta
Danish: Frankrig
English: Cardiac clinical symptoms
Danish: Strukturel hjertesygdom Ja
English: 16 December 2011
Danish: Den 16. December 2011
English: The European Commission issued a decision on 16 December 2011.
Danish: Europa-Kommissionen traf en afgørelse den 16. december 2011.
English: What is the background to the current investigation?
Danish: Hvad er baggrunden for den aktuelle undersøgelse?
English: Which products are affected by the review?
Danish: Hvilke produkter berøres af gennemgangen?
English: The Irish medicines agency will inspect the plant again in October 2011 after which it will go through a 12-month ‘requalification period' where the plant will be carefully monitored and the products will undergo rigorous testing.
Danish: Den irske lægemiddelstyrelse vil inspicere anlægget igen i oktober 2011, hvorefter anlægget vil gennemgå en 12-måneders “rekvalificeringsperiode”, hvor det regelmæssigt overvåges og produkterne nøje testes.
English: • Patients who have any questions should contact their doctors to discuss their treatment.
Danish: • Patienter, der ønsker yderligere oplysninger, bør kontakte lægen for at drøfte deres behandling.
English: The Committee also adopted a strategy to ensure adequate supply of products in the EU should problems reoccur in the future.
Danish: Udvalget vedtog desuden en strategi, der skal sikre tilstrækkelige forsyninger af produkter i EU, hvis problemerne gentager sig.
English: However the Committee aimed to reduce reliance on the plant and made recommendations in January 2011 for the use of products imported from four production sites outside the EU (in Canada, USA, Singapore and Turkey).
Danish: Udvalget tilsigtede imidlertid at mindske afhængigheden af anlægget og afgav derfor i januar 2011 anbefalinger for anvendelse af produkter importeret fra fire produktionsanlæg uden for EU (i Canada, USA, Singapore og Tyrkiet).
English: What are the risks of exposure to endotoxins?
Danish: Hvad er risikoen ved at blive udsat for endotoksiner?
English: These include changes to the design of the plant, new cleaning regimens and the introduction of improved testing methods.
Danish: Forbedringerne vedrører anlæggets konstruktion, nye rengøringsprocedurer og bedre testmetoder.
English: Endotoxins are harmful substances (toxins) released from bacteria after they have died.
Danish: Endotoksiner er skadelige stoffer (toksiner), der afgives fra bakterier, efter at de er døde.
English: If a patient receives a medicine that contains endotoxins, there is a risk that the immune system, the body's defence mechanism, will react against the endotoxins and cause inflammation.
Danish: Hvis en patient får medicin, der indeholder endotoksiner, er der risiko for at immunsystemet, kroppens forsvarssystem, reagerer mod endotoksinerne, så der opstår inflammation.
English: The corrective measures being made at Castlebar will also be applied to Baxter's other manufacturing sites.
Danish: De korrigerende foranstaltninger, der indføres i Castlebar, vil også blive indført på Baxters øvrige fremstillingssteder.
English: The CHMP concluded that the root cause of the presence of endotoxins in the affected production lines was a combination of factors: undetected cracks in equipment may have allowed the growth of bacteria, while the design of the plant and the cleaning methods used may have allowed the contamination to spread.
Danish: CHMP konkluderede, at den tilgrundliggende årsag til tilstedeværelsen af endotoksiner i de pågældende produktionslinjer var en kombination af flere forskellige faktorer: Uopdagede revner i udstyret kan have givet mulighed for bakterievækst, samtidig med at anlæggets konstruktion og de anvendte rengøringsmetoder kan have tilladt forureningen at sprede sig.
English: • Healthcare professionals should continue to monitor dialysis patients for any adverse events including aseptic peritonitis and report any suspected cases to the company using the reporting forms that will be provided by Baxter.
Danish: • De relevante sundhedspersoner skal fortsat overvåge dialysepatienter for alle bivirkninger, herunder aseptisk peritonitis, og indberette alle formodede tilfælde til virksomheden ved hjælp af indberetningsformularer udleveret af Baxter.
English: The European Medicines Agency has completed an investigation into the production processes at Baxter's manufacturing plant in Castlebar, Ireland.
Danish: Det Europæiske Lægemiddelagentur har foretaget en undersøgelse af fremstillingsprocesserne på Baxters anlæg i Castlebar, Irland.