FrancophonIA/ELRC3.0 huggingface dataset:
English: Pyrantel is active against immature stages (L5) and adults of Toxocara canis, adults of Ancylostoma caninum, Toxascaris leonina and Uncinaria stenocephala.
Danish: Pyrantel virker mod uudviklede stadier (L5) og voksne Toxocara canis, voksne Ancylostoma caninum, Toxascaris leonina og Uncinaria stenocephala.
English: Sarolaner is slowly eliminated from plasma (half-life of approximately 12 days) via biliary excretion and elimination through the faeces with minor contributions of metabolic clearance.
Danish: Sarolaner udskilles langsomt fra plasma (halveringstiden er ca. 12 dage) via galde og fæces og i mindre grad hjulpet af metabolisk clearance.
English: Fleas on the animal prior to administration are killed within 8 hours.
Danish: Lopper, der forefindes på hunden, før den får produktet, dør i løbet af 8 timer.
English: − Toxascaris leonina adults;
Danish: − Toxascaris leonina voksne
English: Moxidectin is slowly eliminated from plasma (half-life of approximately 11 days) via biliary excretion and elimination through the faeces with minor contributions of metabolic clearance.
Danish: Moxidectin udskilles langsomt fra plasma (halveringstiden er ca. 11 dage) via galde og fæces i mindre grad hjulpet af metabolisk clearance.
English: Moxidectin is active against adults of Toxocara canis, L4 larvae and immature stages (L5) of Ancylostoma caninum, L4 of Dirofilaria immitis and immature stages (L5) of Angiostrongylus vasorum.
Danish: Moxidectin er aktiv mod voksne Toxocara canis, L4 larver og uudviklede stadier (L5) af Ancylostoma caninum, L4 af Dirofilaria immitis og uudviklede stadier (L5) af Angiostrongylus vasorum.
English: Other nematodes
Danish: Andre nematoder
English: The veterinary medicinal product can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a mono-active flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infections.
Danish: Dette veterinærlægemiddel kan anvendes som en del af den sæsonbetonede behandling af lopper og flåter (til erstatning for behandling med et ensidigt loppe- og flåtmiddel) til hunde, der samtidigt er diagnosticeret med infektion med gastrointestinale nematoder.
English: The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors).
Danish: Sarolaner virker hovedsageligt på insekter og acariner ved at foretage en funktionel blokade af den ligand-styrede kloridkanal (GABAreceptorer og glutamat-receptorer).
English: Simparica Trio tablets are palatable and readily consumed by the majority of dogs when offered by the owner.
Danish: De fleste hunde fortærer dem beredvilligt, når de tilbydes af ejeren.
English: The veterinary medicinal product also provides concurrent efficacy for the prevention of heartworm disease and angiostrongylosis.
Danish: Veterinærlægemidlet er samtidigt også virksomt til forebyggelse mod hjerteorm og angiostrongylose.
English: Lactose monohydrate Sodium starch glycolate type A Meglumine
Danish: Natriumstivelsesglykolat type A Meglumin
English: Sarolaner binding to these receptors prevents the uptake of chloride ions by GABA and glutamate gated ion channels, thus resulting in increased nerve stimulation and death of the target parasite.
Danish: Når disse receptorer ødelægges af sarolaner, hindres optagelsen af kloridioner af GABA og de glutamat-styrede ionkanaler, hvilket resulterer i øget nervestimulation og døden for den parasit, der er målet for behandlingen.
English: 3 mg/0.06 mg/12.5 mg 6 mg/0.12 mg/25 mg 12 mg/0.24 mg/50 mg 24 mg/0.48 mg/100 mg 48 mg/0.96 mg/200 mg 72 mg/1.44 mg/300 mg sarolaner/moxidectin/pyrantel (EN or Latin)
Danish: 3 mg/0.06 mg/12.5 mg 6 mg/0.12 mg/25 mg 12 mg/0.24 mg/50 mg 24 mg/0.48 mg/100 mg 48 mg/0.96 mg/200 mg 72 mg/1.44 mg/300 mg sarolaner/moxidectin/pyrantel (EN eller Latin)
English: Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class.
Danish: Hyppig og gentagen brug af et produkt fra samme klasse kan føre til udvikling af parasitær resistens over for en særlig gruppe af parasitdræbende midler.
English: − Toxocara canis immature adults (L5) and adults;
Danish: − Toxocara canis uudviklede voksne (L5) og voksne
English: sarolaner 3 mg/moxidectin 0.06 mg/pyrantel (as embonate) 12.5 mg sarolaner 6 mg/moxidectin 0.12 mg/pyrantel (as embonate) 25 mg sarolaner 12 mg/moxidectin 0.24 mg/pyrantel (as embonate) 50 mg sarolaner 24 mg/moxidectin 0.48 mg/pyrantel (as embonate) 100 mg sarolaner 48 mg/moxidectin 0.96 mg/pyrantel (as embonate) 200 mg sarolaner 72 mg/moxidectin 1.44 mg/pyrantel (as embonate) 300 mg
Danish: sarolaner 3 mg/moxidectin 0,06 mg/pyrantel (som embonat) 12,5 mg sarolaner 6 mg/moxidectin 0,12 mg/pyrantel (som embonat) 25 mg sarolaner 12 mg/moxidectin 0,24 mg/pyrantel (som embonat) 50 mg sarolaner 24 mg/moxidectin 0,48 mg/pyrantel (som embonat) 100 mg sarolaner 48 mg/moxidectin 0,96 mg/pyrantel (som embonat) 200 mg sarolaner 72 mg/moxidectin 1,44 mg/pyrantel (som embonat) 300 mg
English: − For the prevention of angiostrongylosis by reducing the level of infection with immature adult
Danish: − Til forebyggelse mod angiostrongylose ved at reducere infektionsniveauet med uudviklede voksenstadier (L5) af Angiostrongylus vasorum.
English: EU/2/19/243/001 (3 mg / 0.06 mg / 12.5 mg, 1 tablet) EU/2/19/243/002 (3 mg / 0.06 mg / 12.5 mg, 3 tablets) EU/2/19/243/003 (3 mg / 0.06 mg / 12.5 mg, 6 tablets) EU/2/19/243/004 (6 mg / 0.12 mg / 25 mg, 1 tablet) EU/2/19/243/005 (6 mg / 0.12 mg / 25 mg, 3 tablets) EU/2/19/243/006 (6 mg / 0.12 mg / 25 mg, 6 tablets) EU/2/19/243/007 (12 mg / 0.24 mg / 50 mg, 1 tablet) EU/2/19/243/008 (12 mg / 0.24 mg / 50 mg, 3 tablets) EU/2/19/243/009 (12 mg / 0.24 mg / 50 mg, 6 tablets)
Danish: EU/2/19/243/001 (3 mg / 0,06 mg / 12,5 mg, 1 tablet) EU/2/19/243/002 (3 mg / 0,06 mg / 12,5 mg, 3 tabletter) EU/2/19/243/003 (3 mg / 0,06 mg / 12,5 mg, 6 tabletter) EU/2/19/243/004 (6 mg / 0,12 mg / 25 mg, 1 tablet) EU/2/19/243/005 (6 mg / 0,12 mg / 25 mg, 3 tabletter) EU/2/19/243/006 (6 mg / 0,12 mg / 25 mg, 6 tabletter) EU/2/19/243/007 (12 mg / 0,24 mg / 50 mg, 1 tablet) EU/2/19/243/008 (12 mg / 0,24 mg / 50 mg, 3 tabletter) EU/2/19/243/009 (12 mg / 0,24 mg / 50 mg, 6 tabletter) EU/2/19/243/010 (24 mg / 0,48 mg / 100 mg, 1 tablet) EU/2/19/243/011 (24 mg / 0,48 mg / 100 mg, 3 tabletter) EU/2/19/243/012 (24 mg / 0,48 mg / 100 mg, 6 tabletter)
English: Ticks and fleas need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded.
Danish: Lopper og flåter skal begynde at æde på værten for at blive eksponeret for sarolaner.
English: The product should only be used in dogs when treatment of ticks / fleas and gastrointestinal nematodes is indicated at the same time.
Danish: Produktet må kun anvendes til hunde ved samtidig indikation for behandling mod flåter eller lopper og gastroentestinale nematoder.
English: EU/2/19/243/010 (24 mg / 0.48 mg / 100 mg, 1 tablet) EU/2/19/243/011 (24 mg / 0.48 mg / 100 mg, 3 tablets) EU/2/19/243/012 (24 mg / 0.48 mg / 100 mg, 6 tablets) EU/2/19/243/013 (48 mg / 0.96 mg / 200 mg, 1 tablet) EU/2/19/243/014 (48 mg / 0.96 mg / 200 mg, 3 tablets) EU/2/19/243/015 (48 mg / 0.96 mg / 200 mg, 6 tablets) EU/2/19/243/016 (72 mg / 1.44 mg / 300 mg, 1 tablet) EU/2/19/243/017 (72 mg / 1.44 mg / 300 mg, 3 tablets) EU/2/19/243/018 (72 mg / 1.44 mg / 300 mg, 6 tablets)
Danish: EU/2/19/243/013 (48 mg / 0,96 mg / 200 mg, 1 tablet) EU/2/19/243/014 (48 mg / 0,96 mg / 200 mg, 3 tabletter) EU/2/19/243/015 (48 mg / 0,96 mg / 200 mg, 6 tabletter) EU/2/19/243/016 (72 mg / 1,44 mg / 300 mg, 1 tablet) EU/2/19/243/017 (72 mg / 1,44 mg / 300 mg, 3 tabletter) EU/2/19/243/018 (72 mg / 1,44 mg / 300 mg, 6 tabletter)
English: for dogs 1.25-2.5 kg for dogs >2.5-5 kg for dogs >5-10 kg for dogs >10-20 kg for dogs >20-40 kg for dogs >40-60 kg
Danish: til hunde 1,25-2,5 kg til hunde >2,5-5 kg til hunde >5-10 kg til hunde >10-20 kg til hunde >20-40 kg til hunde >40-60 kg
English: Pork liver powder
Danish: Svineleverpulver
English: Corden Pharma GmbH Otto-Hahn-Str., Plankstadt Baden-Wuerttemberg
Danish: Otto-Hahn-Str., Plankstadt
English: Tablet strength 72 mg/1.44 mg/300 mg
Danish: Tablettens styrke 72 mg/1,44 m g/300 mg
English: Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus.
Danish: samt flere forskellige flåtarter (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus og Rhipicephalus sanguineus).
English: The veterinary medicinal product is exclusively indicated when use against ticks or fleas and gastrointestinal nematodes is indicated at the same time.
Danish: Veterinærlægemidlet er udelukkende angivet til brug mod flåter eller lopper og gastroentestinale nematoder når samtidig brug er indiceret.
English: Special warnings for each target species:
Danish: Særlige advarsler for hver dyreart
English: The treatment schedule should be based on veterinary diagnosis, the local epidemiological situation and/or the epidemiological situation of other areas the dog has visited or is going to visit.
Danish: Behandlingsplanen skal udarbejdes på grundlag af den veterinære diagnose, det lokale epidemiologiske billede og/eller det epidemiologiske billede for andre områder, hunden har været i eller vil komme i. Hvis det ud fra den veterinære vurdering er påkrævet at administrere produktet igen (en eller flere gange), skal efterfølgende administration foretages med mindst 1 måneds intervaller.
English: Tablet strength 48 mg/0.96 mg/200 mg
Danish: Tablettens styrke 48 mg/0,96 m g/200 mg
English: Tablet strength 24 mg/0.48 mg/100 mg
Danish: Tablettens styrke 24 mg/0,48 m g/100 mg
English: Confectioner's sugar Glucose, liquid
Danish: Glucose, flydende
English: Tablet strength 3 mg/0.06 mg/ 12.5 mg
Danish: Tablettens styrke 3 mg/0,06 mg /12,5 mg
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Corden Pharma GmbH
English: Tablet strength 12 mg/0.24 mg/50 mg
Danish: Tablettens styrke 12 mg/0,24 mg/50 mg
English: For the treatment of gastrointestinal roundworm and hookworm infections:
Danish: Til behandling af gastroentestinale angreb af spolorm og hageorm:
English: Tablet strength 6 mg/0.12 mg/25 mg
Danish: Tablettens styrke 6 mg/0,12 mg/ 25 mg
English: Ectoparasites
Danish: Ektoparasiter
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Vask hænder efter håndtering af præparatet.
English: Hypromellose
Danish: Flormelis
English: Simparica Trio chewable tablets for dogs 1.25-2.5 kg Simparica Trio chewable tablets for dogs >2.5-5 kg Simparica Trio chewable tablets for dogs >5-10 kg Simparica Trio chewable tablets for dogs >10-20 kg Simparica Trio chewable tablets for dogs >20-40 kg Simparica Trio chewable tablets for dogs >40-60 kg sarolaner/moxidectin/pyrantel
Danish: Simparica Trio tyggetabletter til hunde på 1,25-2,5 kg Simparica Trio tyggetabletter til hunde på >2,5-5 kg Simparica Trio tyggetabletter til hunde på >5-10 kg Simparica Trio tyggetabletter til hunde på >10-20 kg Simparica Trio tyggetabletter til hunde på >20-40 kg Simparica Trio tyggetabletter til hunde på >40-60 kg sarolaner/moxidectin/pyrantel
English: PACKAGE LEAFLET: Simparica Trio chewable tablets for dogs 1.25-2.5 kg Simparica Trio chewable tablets for dogs >2.5-5 kg Simparica Trio chewable tablets for dogs >5-10 kg Simparica Trio chewable tablets for dogs >10-20 kg Simparica Trio chewable tablets for dogs >20-40 kg Simparica Trio chewable tablets for dogs >40-60 kg
Danish: INDLÆGSSEDDEL: Simparica Trio tyggetabletter til hunde på 1,25-2,5 kg Simparica Trio tyggetabletter til hunde på >2,5-5 kg Simparica Trio tyggetabletter til hunde på >5-10 kg Simparica Trio tyggetabletter til hunde på >10-20 kg Simparica Trio tyggetabletter til hunde på >20-40 kg Simparica Trio tyggetabletter til hunde på >40-60 kg
English: Simparica Trio chewable tablets for dogs 1.25-2.5 kg Simparica Trio chewable tablets for dogs >2.5-5 kg Simparica Trio chewable tablets for dogs >5-10 kg Simparica Trio chewable tablets for dogs >10-20 kg Simparica Trio chewable tablets for dogs >20-40 kg Simparica Trio chewable tablets for dogs >40-60 kg
Danish: Simparica Trio tyggetabletter til hunde på 1,25-2,5 kg Simparica Trio tyggetabletter til hunde på >2,5-5 kg Simparica Trio tyggetabletter til hunde på >5-10 kg Simparica Trio tyggetabletter til hunde på >10-20 kg Simparica Trio tyggetabletter til hunde på >20-40 kg Simparica Trio tyggetabletter til hunde på >40-60 kg
English: If based on veterinarian opinion re-administration(s) of the product is required, any subsequent administration(s) must follow the minimum 1-month interval schedule.
Danish: Behandlingsplanen skal udarbejdes på basis af den veterinære diagnose, det lokale epidemiologiske billede og/eller det epidemiologiske billede for andre områder, hunden har været i eller vil komme i. Hvis det ud fra den veterinære vurdering er påkrævet at administrere produktet igen (en eller flere gange), skal efterfølgende administration foretages med mindst 1 måneds intervaller.
English: The European Commission issued a decision on 1 July 2010.
Danish: Europa-Kommissionen traf en afgørelse den 1. juli 2010.
English: 2 Article 20 of Regulation (EC) No 726/2004.
Danish: 2 Artikel 20 i forordning (EF) nr. 726/2004.
English: Ref. EMEA/727399/2009 rev. EMEA/H/A-31/1097
Danish: EMEA/727399/2009 rev. EMEA/H/A-31/1097
English: Most of these medicines are authorised nationally.
Danish: Størstedelen af disse er nationalt godkendte lægemidler.
English: Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Danish: Artikel 31 i direktiv 2001/83/EF, med senere ændringer, indbringelse af interesse for Fællesskabet.
English: A communication containing the key messages of this review will be distributed to doctors at national level.
Danish: En meddelelse med hovedbudskaberne i denne vurdering uddeles til læger på nationalt plan.
English: • These medicines should only be used in accordance with the updated prescribing information.
Danish: • Disse lægemidler bør derfor kun anvendes i overensstemmelse med de opdaterede ordinationsoplysninger.
English: It may affect several organs such as the liver, lungs and heart.
Danish: Sygdommen kan påvirke adskillige organer, herunder lever, lunger og hjerte.
English: The medicines are only used by MR specialists.
Danish: Lægemidlerne anvendes udelukkende af MR-specialister.
English: London, 1 July 2010 Doc.
Danish: London, den 1. juli 2010 Dok.ref.
English: • information on the cases of NSF reported for each agent.
Danish: • oplysninger om de indberettede tilfælde af NSF for hvert stof.
English: At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised agents.
Danish: Samtidig anmodede Europa-Kommissionen CHMP om at foretage samme vurdering af de centralt godkendte stoffer.
English: This included information from preclinical and clinical studies, as well as information provided by the companies that make the medicines.
Danish: Dette omfattede data fra prækliniske og kliniske undersøgelser samt oplysninger fra de virksomheder, der fremstiller lægemidlerne.
English: Two of these products - OptiMARK (gadoversetamide) and Vasovist (gadofosveset) - have received a marketing authorisation that is valid throughout the European Union (EU).
Danish: To af lægemidlerne - OptiMARK (gadoversetamid) og Vasovist (gadofosveset) - har opnået markedsføringstilladelse med gyldighed i hele Den Europæiske Union (EU).
English: Patients receive an injection of the contrast agent just before or during the scan.
Danish: Patienterne injiceres med kontraststoffet umiddelbart inden eller under scanningen.
English: The Committee also concluded that an additional factor that may contribute to the risk of NSF is the way these medicines are used (such as the dose, how often they are given and for how long).
Danish: CHMP konkluderede endvidere, at en yderligere faktor, der kan øge risikoen for NSF, er måden, hvorpå disse lægemidler anvendes (såsom dosis, hvor hyppigt de gives, og hvor længe).
English: In December 2007, the Scientific Advisory Group (SAG) for Diagnostics of the CHMP was convened to discuss the approach of the PhVWP.
Danish: I december 2007 blev CHMP's videnskabelige rådgivende gruppe (SAG) for diagnostik indkaldt for at drøfte PhVWP's tilgang.
English: (Magnevist, Magnegita, and Gado-MRT-ratiopharm);
Danish: (Magnevist, Magnegita og Gado-MRT-ratiopharm)
English: • a warning that the elderly may be at particular risk of NSF, because their kidneys are less able to remove gadolinium from the body;
Danish: • en advarsel om, at ældre kan have særlig stor risiko for NSF, fordi deres nyrer har sværere ved at fjerne gadolinium fra kroppen;
English: Questions and answers on the review of gadolinium-containing contrast agents
Danish: Spørgsmål og svar vedrørende vurdering af gadoliniumholdige kontraststoffer
English: • a statement that there is no evidence to support the initiation of haemodialysis (a blood clearance technique) to prevent or treat NSF in patients not already undergoing haemodialysis;
Danish: • en erklæring om, at der ikke er nogen dokumentation, der understøtter påbegyndelse af hæmodialyse (en blodrensningsteknik) til forebyggelse eller behandling af NSF hos patienter, som ikke allerede er i hæmodialyse;
English: An association between the use of gadolinium-containing contrast agents and NSF was first observed in January 2006, when cases of the disease were reported in Denmark and Austria in patients with kidney problems undergoing MRI scans.
Danish: En forbindelse mellem anvendelsen af gadoliniumholdige kontraststoffer og NSF blev første gang observeret i januar 2006, hvor der blev indberettet tilfælde af sygdommen i Danmark og Østrig hos nyrepatienter, der fik foretaget MR-scanning.
English: Finally, the CHMP recommended that further studies should be carried out on the long-term retention of gadolinium in human tissues (such as bone) released from gadolinium-containing contrast agents.
Danish: Endelig anbefalede CHMP, at der skulle foretages yderligere undersøgelser af den langsigtede ophobning af gadolinium i humant væv (f.eks. knoglerne), der frigives fra gadoliniumholdige kontraststoffer.
English: They contain gadolinium, a ‘rare earth' metal, which is used as a ‘contrast enhancer' to help make the inside of the body more visible on the scan.
Danish: De indeholder gadolinium, som er et metal i gruppen af "sjældne jordarter", og som anvendes til kontrastforstærkning for at give et tydeligere scanningsbillede af kroppens indre dele.
English: In addition, the prescribing information of all gadolinium-containing contrast agents should include:
Danish: Desuden bør ordinationsoplysningerne for alle gadoliniumholdige kontraststoffer indeholde:
English: The review was carried out under ‘Article 31'1 and ‘Article 20'2 referrals.
Danish: Vurderingen blev gennemført inden for rammerne af en indbringelsesprocedure i henhold til artikel 311 og artikel 202.
English: During 2007, more cases of the disease were reported and the CHMP's Pharmacovigilance Working Party (PhVWP) held several discussions to establish how the risk of NSF could be reduced.
Danish: I løbet af 2007 blev der indberettet flere tilfælde af sygdommen, og CHMP's arbejdsgruppe vedrørende lægemiddelovervågning (PhVWP) afholdt en række drøftelser om, hvordan risikoen for NSF kunne reduceres.
English: However, the CHMP recognised that within the high-risk group the risk of NSF with gadoversetamide and gadodiamide appears higher than with gadopentetic acid, based on physicochemical properties, studies in animals and the number of cases of NSF reported worldwide.
Danish: CHMP anerkendte imidlertid, at risikoen for NSF ved gadoversetamid og gadodiamid virker højere inden for højrisikogruppen end ved gadopentetinsyre på grundlag af fysisk-kemiske egenskaber, dyreforsøg og antallet af indberettede tilfælde af NSF på verdensplan.
English: Gadolinium-containing contrast agents include nine different active substances: gadobenic acid, gadobutrol, gadodiamide, gadofosveset, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Danish: Gadoliniumholdige kontraststoffer omfatter følgende ni forskellige aktive stoffer: gadobensyre, gadobutrol, gadodiamid, gadofosveset, gadopentetinsyre, gadoterinsyre, gadoteridol, gadoversetamid og gadoxetsyre.
English: Consequently, in November 2008 the Danish medicines regulatory agency asked the CHMP to carry out an assessment of the risk of NSF for the non-centrally authorised gadolinium-containing contrast agents, and to recommend measures that could be taken to reduce this risk.
Danish: Således anmodede den danske lægemiddelstyrelse i november 2008 CHMP om at foretage en vurdering af risikoen ved NSF for de decentralt godkendte gadoliniumholdige kontraststoffer og anbefale, hvilke foranstaltninger der kunne træffes for at reducere denne risiko.
English: NSF is a rare disease that causes thickening of the skin and connective tissues in patients with severe kidney problems.
Danish: NSF er en sjælden sygdom, der forårsager fortykkelse af huden og bindevævet hos patienter med svære nyreproblemer.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed with the SAG classification of gadolinium-containing contrast agents into high-, medium- and low-risk agents based on their risk of causing NSF.
Danish: På baggrund af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget godkendte CHMP den videnskabelige rådgivende gruppes klassificering af gadoliniumholdige kontraststoffer i en høj, middelhøj og lav risikogruppe på baggrund af risikoen for, at de forårsager NSF.
English: The SAG also highlighted the need to harmonise the prescribing information regarding the use of these agents particularly in high-risk groups, such as pregnant and breast-feeding women, children, the elderly and patients undergoing liver transplant.
Danish: Den videnskabelige rådgivende gruppe fremhævede endvidere behovet for at harmonisere ordinationsoplysningerne vedrørende anvendelsen af disse stoffer, særlig hos højrisikogrupper, såsom gravide og ammende kvinder, børn, ældre og patienter, der skal have en levertransplantation.
English: • as a precaution, breastfeeding should be discontinued for at least 24 hours after the patient has received a high-risk agent;
Danish: • amning som en sikkerhedsforanstaltning indstilles i mindst 24 timer, efter at patienten har modtaget stoffer fra højrisikogruppen
English: Why were gadolinium-containing contrast agents reviewed?
Danish: Hvorfor blev gadoliniumholdige kontraststoffer vurderet?
English: The European Medicines Agency has completed a review of the risk of nephrogenic systemic fibrosis (NSF) in patients receiving gadolinium-containing contrast agents.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en vurdering af risikoen for nefrogen systemisk fibrose (NSF) hos patienter, der får gadoliniumholdige kontraststoffer.
English: • Gadolinium-containing contrast agents remain suitable diagnostic agents for use in patients undergoing an MRI scan, but doctors should be aware of the associated risk of NSF especially in patients with kidney problems, and other high-risk groups.
Danish: • Gadoliniumholdige kontraststoffer er fortsat egnede diagnostiske midler til anvendelse hos patienter, der skal have foretaget en MR-scanning, men lægen skal være opmærksom på den tilknyttede risiko for NSF, særlig hos patienter med nyreproblemer og andre højrisikogrupper.
English: What are gadolinium-containing contrast agents?
Danish: Hvad er gadoliniumholdige kontraststoffer?