FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 30 ml syringe contains 9927 mg gadoversetamide.
Danish: Hver 30 ml injektionssprøjte indeholder 9.927 mg gadoversetamid.
English: Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of the dose of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.
Danish: Begrænsede data fra andre gadolinium-kontrastmidler tyder på, at foretagelse af en MR-undersøgelse med injektion af en dosis på 300 mikromol/kg legemsvægt Optimark muligvis kan føre til større diagnostisk sikkerhed med hensyn til udelukkelse af yderligere kranielle metastaser hos patienter med en kendt, solitær, resektabel metastase.
English: Each 20 ml syringe contains 6618 mg gadoversetamide.
Danish: Hver 20 ml injektionssprøjte indeholder 6.618 mg gadoversetamid.
English: What Optimark looks like and contents of the pack Optimark syringes contain a clear, colourless to pale yellow solution.
Danish: Optimark hætteglas indeholder en klar, farveløs til lys gul opløsning.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Text for the immediate packaging of the 10 ml pre-filled syringe
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Tekst til den ydre emballage for 10 ml fyldte injektionssprøjter
English: 20 ml of the solution contain 28.75 mg sodium.
Danish: 20 ml opløsning indeholder 28,75 mg natrium.
English: Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15 millimol.
Danish: Hver 30 ml injektionssprøjte indeholder 9.927 mg gadoversetamid, svarende til 15 millimol.
English: As with any paramagnetic contrast agent, enhancement of MRI with Optimark may impair the visualization of existing lesions.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Som ved alle paramagnetiske kontrastmidler kan MRI-billede-kontrastforstærkning med Optimark hæmme visualiseringen af eksisterende læsioner.
English: Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol.
Danish: Hvert 20 ml hætteglas indeholder 6618 mg gadoversetamid, svarende til 10 millimol.
English: Pre-filled syringes:
Danish: Fyldte injektionssprøjter:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Text for the immediate packaging of the 10 ml vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Tekst til den ydre emballage for 10 ml hætteglas
English: The most common side effects were a strange taste in the mouth, feeling hot, headache and dizziness.
Danish: En mærkelig smag i munden, hedeture, hovedpine og svimmelhed er de almindeligste bivirkninger.
English: Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10 millimol.
Danish: Hver 20 ml injektionssprøjte indeholder 6.618 mg gadoversetamid, svarende til 10 millimol.
English: How to store Optimark
Danish: Sådan vil De få Optimark
English: swelling around the eyes, abnormal ECG heart tracing, fainting, vomiting
Danish: Hævelser omkring øjnene, unormalt elektrokardiogram (ekg), besvimelse,
English: Each 10 ml syringe contains 3309 mg gadoversetamide.
Danish: Hver 10 ml injektionssprøjte indeholder 3.309 mg gadoversetamid.
English: Final Study Report:
Danish: Oversigt over indlægssedlen:
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m²) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Danish: Optimark er kontraindiceret til patienter med alvorligt nedsat nyrefunktion (GFR < 30 ml/min/1,73 m²) og/eller akut nyreskade, samt til patienter, som har gennemgået en levertransplantation, og patienter i den perioperative levertransplantationsperiode.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml, 20 ml and 30 ml pre-filled syringes
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Tekst til den ydre emballage for 10 ml, 15 ml, 20 ml and 30 ml fyldte injektionssprøjter
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Danish: Optimark er kontraindiceret til patienter med alvorligt nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2) og/eller akut nyreskade, samt til patienter, som har gennemgået en levertransplantation, og patienter i den perioperative levertransplantationsperiode.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml indeholder 330,9 mg gadoversetamid svarende til 500 mikromol.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Optimark 500 mikromol/ml injektionsvæske, opløsning i hætteglas Gadoversetamid
English: Each 15 ml syringe contains 4963.5 mg gadoversetamide.
Danish: Hvert 15 ml hætteglas indeholder 4963,5 mg gadoversetamid.
English: Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Danish: Hvert 15 ml hætteglas indeholder 4963,5 mg gadoversetamid, svarende til 7,5 millimol.
English: to <1/100)
Danish: Almindelig (≥1/100 til <1/10)
English: Pruritus, Rash
Danish: Pruritus, udslæt
English: Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions (see section 4.8).
Danish: Disse kan vise sig i form af kardiovaskulære og respiratoriske reaktioner samt hudreaktioner (Se pkt.
English: Precautions are necessary when examining these patients (e.g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.
Danish: Det er nødvendigt at tage forholdsregler ved undersøgelse af disse patienter (f.eks. monitorering af patienten).
English: 1 x 15 ml 10 x 15 ml
Danish: 1 x 15 ml
English: Pre-filled syringe Solution for injection in pre-filled syringe.
Danish: Injektionsvæske, opløsning, i fyldt injektionssprøjte.
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3).
Danish: Optimark er kontraindiceret til patienter med alvorligt nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2) og/eller akut nyreskade, samt til patienter, som har gennemgået en levertransplantation, og patienter i den perioperative levertransplantationsperiode (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Optimark 500 micromol/ml solution for injection in pre-filled syringe Optimark 500 micromol/ml solution for injection in vial
Danish: Optimark 500 mikromol/ml injektionsvæske, opløsning i fyldt injektionssprøjte Optimark 500 mikromol/ml injektionsvæske, opløsning i hætteglas
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml and 20 ml vials
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Tekst til den ydre emballage for 10 ml, 15 ml og 20 ml hætteglas
English: Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol.
Danish: Hvert 10 ml hætteglas indeholder 3309 mg gadoversetamid, svarende til 5 millimol.
English: Keep the syringe in the outer carton in order to protect from light.
Danish: Opbevar sprøjterne i den ydre karton for at beskytte mod lys.
English: Uncommon (≥1/1,000
Danish: Ikke almindelig (≥1/1.000 til <1/100)
English: 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Danish: 1 ml indeholder 330,9 mg gadoversetamid svarende til 500 mikromol.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
English: 30 ml (1, 10 syringes)
Danish: 30 ml (1, 10 sprøjter)
English: IV use.
Danish: brug.
English: 15 ml (1, 10 syringes)
Danish: 15 ml (1, 10 sprøjter)
English: Blood creatinine increased, Haematuria
Danish: Blodkreatinin forhøjet, hæmaturi
English: 1 x 20 ml 10 x 20 ml
Danish: 10 x 20 ml
English: 20 ml (1, 10 syringes)
Danish: 20 ml (1, 10 sprøjter)
English: 1 x 30 ml 10 x 30 ml
Danish: 10 x 30 ml
English: Somnolence, Burning sensation Syncope
Danish: Krampeanfald, tremor, døsighed, brændende fornemmelse
English: Vial 20 ml of the solution contain 28.75 mg sodium.
Danish: Hætteglas 20 ml opløsning indeholder 28,75 mg natrium.
English: The peel-off tracking label on the pre-filled syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used.
Danish: Den aftagelige etiket på hætteglassene, som kan spores, skal klæbes ind i patientens journal for at sikre akkurat registrering af anvendt gadolinium kontrastmiddel.
English: 1 x 10 ml 10 x 10 ml
Danish: 1 x 10 ml
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Tekst til den indre emballage for 15 ml, 20 ml and 30 ml fyldte injektionssprøjter
English: 15 ml (1, 10 vials)
Danish: 15 ml (1, 10 hætteglas)
English: Excipient(s) with known effect: 20 ml of the solution contain 28.75 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på 20 ml opløsning indeholder 28,75 mg natrium.
English: 20 ml (1, 10 vials)
Danish: 20 ml (1, 10 hætteglas)
English: Pre-filled syringe 1 x 10 ml: EU/1/07/398/007 10 x 10 ml: EU/1/07/398/008 1 x 15 ml: EU/1/07/398/009 10 x 15 ml: EU/1/07/398/010 1 x 20 ml: EU/1/07/398/011 10 x 20 ml: EU/1/07/398/012
Danish: Fyldt injektionssprøjte 1 x 10 ml: EU/1/07/398/007 10 x 10 ml: EU/1/07/398/008 1 x 15 ml: EU/1/07/398/009 10 x 15 ml: EU/1/07/398/010 1 x 20 ml: EU/1/07/398/011 10 x 20 ml: EU/1/07/398/012
English: Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Danish: Optimark 500 mikromol/ml injektionsvæske, opløsning i hætteglas Gadoversetamid
English: How Optimark is given
Danish: Hvis De har fået for meget Optimark
English: Nasal congestion, Throat irritation
Danish: Nasal tilstopning, halsirritation
English: Vial 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Danish: Hætteglas 1 ml indeholder 330,9 mg gadoversetamid svarende til 500 mikromol.
English: Pre-filled syringe
Danish: Nyrer og urinveje
English: Not all pack-sizes may be marketed.
Danish: 10 x 30 ml Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
Danish: Optimark 500 mikromol/ml injektionsvæske, opløsning, i fyldt injektionssprøjte Gadoversetamid
English: Posology
Danish: Dato
English: Pre-filled syringe 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Danish: Fyldt injektionssprøjte 1 ml indeholder 330,9 mg gadoversetamid svarende til 500 mikromol.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml and 20 ml vials
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Tekst til den ydre emballage for 15 ml and 20 ml hætteglas
English: Each 10 ml vial contains 3309 mg gadoversetamide.
Danish: Hvert 10 ml hætteglas indeholder 2209 mg gadoversetamid.
English: Common
Danish: Synkope
English: ml/h/kg) and the two adult populations (82.1 ± 16.8 and 56.5 ± 9.7 ml/h/kg in the 19 to 64 and ≥ 65
Danish: 2,5 ± 0,5 h-1 i aldersgrupperne 19 til 64 og ≥ 65 år).
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), ansøger(e) i medlemsstaterne
English: Alapis Romania SRL, Romania, Leordeni nr.13 Street, Bragadiru, IIfov County, 077025
Danish: Alapis Romania SRL, Romania, Leordeni nr.13 Street, Bragadiru, IIfov County, 077025 Romania
English: Oral Solution Oral use
Danish: Oral opløsning
English: Levotiroxina Alapis
Danish: Levotiroxina Alapis 100 microgram/ml
English: This summary was last updated on 28 January 2013.
Danish: Dette sammendrag blev sidst ajourført den 28/01/2013.
English: Continuous release means that monensin is released slowly from the device.
Danish: Kontinuerlig frigivelse betyder at monensin frigives langsomt fra anordningen.
English: It is mainly active against Gram-positive bacteria.
Danish: Det er hovedsagelig aktivt mod grampositive bakterier.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Kexxtone on 28 January 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Kexxtone den 28/01/2013.
English: Kexxtone must not be used in animals weighing less than 300 kg.
Danish: Kexxtone må ikke anvendes til dyr, der vejer under 300 kg.
English: Exposure to monensin may result in an allergic response in certain people.
Danish: Udsættelse for monensin kan medføre en allergisk reaktion hos nogle personer.
English: If this occurs, the product should be re-administered if undamaged.
Danish: Hvis dette sker, skal produktet indgives på ny, hvis det er ubeskadiget.
English: The cumulative ketosis rate was 11.5% in the Kexxtone group compared with 25.6% in the placebo group.
Danish: Den samlede andel af ketose var 11,5 % i Kexxtone-gruppen, sammenholdt med 25,6 % i placebogruppen.
English: It attaches to the surface of bacterial cells and interferes with the mechanism for transporting nutrients.
Danish: Det bindes til bakteriernes overflade og griber ind i deres mekanisme til transport af næringsstoffer.
English: Kexxtone has been studied in one main study involving 1,312 commercial dairy cows.
Danish: Kexxtone blev undersøgt i én hovedundersøgelse, der omfattede 1 312 malkekøer fra kommercielle brug.
English: Other information about Kexxtone:
Danish: Andre oplysninger om Kexxtone:
English: Dogs, horses, other equines or guinea fowl must not be allowed access to Kexxtone as consumption of intraruminal device contents can be fatal in these species.
Danish: Hunde, heste, andre dyr af hestefamilien eller perlehøns må ikke få adgang til Kexxtone, da indtagelse af indholdet i det intraruminale indlæg kan være dødelig for disse arter.
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysningerne om udleveringsbestemmelserne for dette lægemiddel findes på etiketten/yderemballagen.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og før kødet eller mælken kan anvendes til konsum.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Kexxtone exceed the risks for the approved indication and recommended that Kexxtone be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Kexxtone overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Kexxtone.
English: This improves energy production in the cow's body and reduces the level of ketones in the blood.
Danish: Dette øger energiproduktionen i koens krop og nedsætter indholdet af ketonstoffer i blodet.
English: People who are known to be hypersensitive (allergic) to monensin or any of the ingredients should avoid contact with the product.
Danish: Hvis man er overfølsom (allergisk) over for monensin eller andre af indholdsstofferne, bør man undgå kontakt med produktet.
English: Kexxtone is a veterinary medicine that contains the active substance monensin.
Danish: Kexxtone er veterinærlægemiddel, der indeholder det aktive stof monensin.
English: A single dose of Kexxtone was compared with a placebo (dummy treatment) given three to four weeks before the expected calving date.
Danish: En enkelt dosis af Kexxtone blev sammenlignet med placebo (virkningsløs behandling) og blev givet 3-4 uger før den forventede kælvningsdato.
English: The withdrawal period for Kexxtone for cattle is zero days for meat and milk.
Danish: Tilbageholdelsestiden for Kexxtone for kød og mælk er nul dage.
English: The active substance in Kexxtone, monensin, is an antibiotic produced by natural fermentation.
Danish: Det aktive stof i Kexxtone, monensin, er et antibiotikum, der fremstilles ved naturlig gæring.
English: Kexxtone is used to reduce the incidence of ketosis in dairy cows and heifers which are expected to develop ketosis in the period around calving.
Danish: Kexxtone anvendes til at mindske forekomsten af ketose hos malkekøer og drægtige kvier, der forventes at udvikle ketose i tidsrummet omkring kælvning.
English: People should not eat, drink or smoke while handling Kexxtone.
Danish: Ved håndtering Kexxtone må man ikke spise, drikke eller ryge.
English: Accidental administration of more than one intraruminal device could result in side effects typical of monensin overdose, including decreased appetite, scouring (diarrhoea) and lethargy.
Danish: Utilsigtet indgivelse af mere end et intraruminalt indlæg kan medføre bivirkninger, der er typiske for overdosering af monensin, herunder nedsat appetit, diarré og sløvhed.
English: Clinical ketosis was defined based on a minimum level of the substance ß-hydroxybutyrate in the blood in combination with one or more clinical signs of ketosis.
Danish: Klinisk ketose blev defineret som et minimumsindhold af stoffet ß-hydroxysmørsyre i blodet kombineret med et eller flere kliniske tegn på ketose.
English: Treated cattle should be held in a confined area for one hour after administration to observe for failure to swallow or regurgitation.
Danish: De behandlede kreaturer skal holdes i et aflukket område i en time efter indgivelsen for at iagttage dem for svigtende synkning eller opgylpning.
English: A single intraruminal device is given to a dairy cow or heifer three to four weeks before the expected calving, using an appropriate administration tool.
Danish: Der anbringes et enkelt intraruminalt indlæg i koen eller kvien 3-4 uger før forventet kælvning ved hjælp af et passende redskab til indgivelse.
English: If damaged a new intraruminal device should be used.
Danish: Hvis det er beskadiget, skal der anvendes et nyt intraruminalt indlæg.
English: Ketosis is a metabolic disturbance in which blood glucose levels are low and substances called ketones (such as acetoacetatic acid and β-hydroxybutyrate) accumulate in the blood.
Danish: Ketose er en stofskifteforstyrrelse, hvor blodets indhold af glukose er lavt, og der ophober sig ketonstoffer (såsom aceteddikesyre og βhydroxysmørsyre) i blodet.
English: The main measure of effectiveness was the cumulative rate of clinical ketosis in the cows over the 15 to 16 weeks after calving.
Danish: Behandlingens virkning blev hovedsagelig bedømt på stigningen i forekomsten af klinisk ketose hos køerne i løbet af en periode på 15-16 uger efter kælvning.
English: What is the risk associated with Kexxtone?
Danish: Hvilken risiko er der forbundet med Kexxtone?
English: It is available as a continuous-release intraruminal device (a device administered through the animal's mouth and placed within the rumen, or first stomach, of cattle).
Danish: Et intraruminalt indlæg er en anordning, der indføres gennem dyrets mund og anbringes i dyrets vom eller første mave.
English: Why has Kexxtone been approved?
Danish: Hvorfor blev Kexxtone godkendt?
English: What is Kexxtone?
Danish: Hvad er Kexxtone?
English: The person administering Kexxtone should wear gloves when handling the product, including when retrieving a regurgitated intraruminal device.
Danish: Der skal anvendes handsker ved håndtering af produktet, herunder ved udtagelse af et opgylpet intraruminalt indlæg.
English: Gloves should be removed and hands and exposed skin washed after handling the product.
Danish: Efter håndtering af produktet skal handskerne aftages, og den udsatte hud vaskes.
English: How has Kexxtone been studied?
Danish: Hvordan blev Kexxtone undersøgt?
English: What is Kexxtone used for?
Danish: Hvad anvendes Kexxtone til?
English: Cattle should be re-checked for up to four days after dosing in case the intraruminal device has not been fully swallowed and has lodged in the oesophagus (the gullet or tube leading from the mouth to the rumen).
Danish: Kontrollen af kreaturerne skal gentages i indtil fire dage efter indgivelsen med henblik på, at det intraruminale indlæg ikke er fuldstændig nedsvælget eller har sat sig fast i spiserøret.
English: What benefit has Kexxtone shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Kexxtone?
English: Monensin changes the population of microbes in the rumen resulting in an increase of the bacteria that produce propionate, a substance used to make glucose.
Danish: så der kommer flere bakterier, der producerer propionsyre, som anvendes til dannelse af glukose.
English: How does Kexxtone work?
Danish: Hvordan virker Kexxtone?
English: In accordance with EU legislation, this type of action required that an EU review procedure be carried out.
Danish: I henhold til EU-lovgivningen kræver sådanne handlinger, at der foretages en EU-gennemgang.
English: More about the procedures
Danish: Mere om procedurerne
English: Contact our press officers Monika Benstetter or Martin Harvey
Danish: Kontakt vores pressemedarbejder Monika Benstetter eller Martin Harvey
English: For the re-examination procedure the PRAC confirmed its previous position.
Danish: Ved den fornyede overvejelse bekræftede PRAC sit tidligere standpunkt.
English: 19 December 2013 EMA/809470/2013
Danish: Den 19. december 2013 EMA/809470/2013
English: Siegemund M. Firstly presented at European Society of Anaesthesiology conference 2012.
Danish: Siegemund M. Første gang fremlagt på European Society of Anaesthesiology's konference i 2012.
English: While the re-examination was ongoing, some Member States decided to suspend or limit the marketing or use of these medicines in their territories.
Danish: Mens den fornyede overvejelse foregik, besluttede nogle medlemsstater at suspendere eller begrænse markedsføringen eller anvendelsen af disse lægemidler på deres område.
English: References: 1.
Danish: Litteraturhenvisninger: 1.
English: * The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Danish: * CMDh er en lægemiddelkontrolmyndighed, der repræsenterer Den Europæiske Unions (EU's) medlemsstater.
English: This review procedure ran in parallel with the re-examination of the PRAC's June 2013 recommendation and both procedures were finalised on 10 October 2013.
Danish: Denne gennemgang fandt sted sideløbende med den fornyede overvejelse af PRAC's anbefaling fra juni 2013, og begge procedurer afsluttedes den 10. oktober 2013.
English: • Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse.
Danish: • Patienter, der har spørgsmål eller betænkeligheder, bør tale med den behandlende læge, apotekspersonalet eller en sygeplejerske.
English: The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety, and other available treatment options should be considered.
Danish: Den forventede fordel ved behandlingen bør nøje afvejes mod usikkerheden omkring den langsigtede sikkerhed, og andre behandlingsmuligheder bør overvejes.