FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1 Example calculations for weights ranging from 40 kg to 200 kg
Danish: Tabel 1 Eksempler på beregninger for legemsvægt i intervallet 40-200 kg
English: Co-administration of a strong CYP3A4 inducer (such as phenobarbital, rifampicin, carbamazepine, phenytoin, St. John's Wort) is expected to reduce the effect of eravacycline (see sections 4.2 and 4.5).
Danish: Samtidig administration af en potent CYP3A4-inducer (f.eks. phenobarbital, rifampicin, karbamazepin, phenytoin eller prikbladet perikon) forventes at reducere effekten af eravacyclin (se pkt.
English: Mild to moderate infusion site reactions, including pain or discomfort, erythema and swelling or inflammation at the injection site as well as superficial thrombophlebitis and/or phlebitis have been reported in patients treated with eravacycline.
Danish: Der er rapporteret om lette til moderate reaktioner på infusionsstedet, herunder smerter eller ubehag, erytem og hævelse eller inflammation ved injektionsstedet samt overfladisk tromboflebitis og/eller flebitis hos patienter i behandling med eravacyclin.
English: In patients co-administered strong CYP3A4 inducers the recommended dose regimen is 1.5 mg/kg eravacycline every 12 hours for 4 to 14 days (see sections 4.4 and 4.5).
Danish: Hos patienter, der samtidig får potente CYP3A4-inducere, er det anbefalede dosisregime 1,5 mg/kg eravacyclin hver 12. time i 4-14 dage (se pkt.
English: Potential for other medicinal products to affect the pharmacokinetics of eravacycline
Danish: Andre lægemidler, der kan påvirke eravacyclins farmakokinetik
English: The geometric mean AUC0-inf for eravacycline was increased by 22.9%, 37.9%, and 110.3% for subjects with mild, moderate, and severe hepatic impairment versus healthy subjects, respectively.
Danish: Det geometriske AUC0-inf-gennemsnit for eravacyclin steg med hhv. 22,9 %, 37,9 % og 110,3 % hos patienter med let, moderat og svært nedsat leverfunktion vs. raske forsøgspersoner.
English: Each vial should be reconstituted with 5 mL water for injections, and swirled gently until the powder has dissolved entirely.
Danish: Hvert hætteglas bør rekonstitueres med 5 ml vand til injektionsvæsker og omrystes forsigtigt, indtil pulveret er helt opløst.
English: • Swelling of the face
Danish: • hævelse i ansigtet
English: Thrombophlebitis a
Danish: Tromboflebitisa Flebitis b
English: Rash Hyperhidrosis
Danish: Udslæt Hyperhidrose
English: Bone discolouration (in the absence of histological findings), which was not fully reversible over recovery periods of up to 7-weeks, was observed in rats and monkeys after 13 weeks of dosing.
Danish: Der sås misfarvning af knogler (ingen histologiske fund) hos rotter og aber efter 13 ugers dosering, en tilstand, der ikke var fuldt reversibel efter restitutionsperioder på op til 7 uger.
English: In repeated dose toxicity studies in rats, dogs and monkeys, lymphoid depletion/atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets (dog and monkey), in association with bone marrow hypocellularity, and adverse gastrointestinal effects (dog and monkey) were observed with eravacycline.
Danish: I toksicitetsstudier med gentagne doser eravacyclin hos rotter, hunde og aber sås lymfoid depletion/atrofi i lymfeknuder, milt og brissel, nedsat antal erytrocytter, retikulocytter, leukocytter og trombocytter (hund og abe) i forbindelse med hypocellularitet i knoglemarven samt gastrointestinale bivirkninger (hund og abe).
English: • Losing consciousness
Danish: • bevidsthedstab.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine and phenytoin (used to treat epilepsy), St. John's Wort (a herbal remedy used for treatment of depression and anxiety) itraconazole (a medicine to treat fungal infections), ritonavir, atazanavir, lopinavir and saquinavir (medicines used to treat viral infections), and cyclosporine (a medicine used to suppress the immune system).
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig (herunder rifampicin og clarithromycin (antibiotika), phenobarbital, karbamazepin og phenytoin (mod epilepsi), prikbladet perikon (naturlægemiddel mod depression og angst), itraconazol (mod svampeinfektioner), ritonavir, atazanavir, lopinavir og saquinavir (mod virusinfektioner) og cyclosporin (anvendes til at dæmpe immunforsvaret)).
English: Seek urgent medical attention if you suspect you have an anaphylactic reaction, or develop any of the following symptoms, whilst receiving Xerava:
Danish: Søg straks lægehjælp, hvis du tror, at du oplever en anafylaktisk reaktion eller får et eller flere af følgende symptomer under behandlingen med Xerava:
English: The contents of the required number of vials should each be reconstituted with 5 mL water for injections, and swirled gently until the powder has dissolved entirely.
Danish: Det ønskede antal hætteglas skal hver især rekonstitueres med 5 ml vand til injektionsvæsker og drejes forsigtigt rundt, indtil pulveret er helt opløst.
English: Viridans Streptococcus spp.
Danish: Streptococcus spp.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INNER CARTON: MULTIPACK, CONTAINS NO BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE INDRE KARTON: MULTIPAKNING, UDEN BLUE BOX
English: Eravacycline, TP-498 and TP-6208 are not inducers of CYP1A2, CYP2B6 or CYP3A4.
Danish: Eravacyclin, TP-498 og TP-6208 er ikke inducere af CYP1A2, CYP2B6 og CYP3A4.
English: Hypersensitivity to tetracycline class antibiotics.
Danish: Overfølsomhed over for antibiotika i tetracyclin-klassen.
English: The geometric mean Cmax for eravacycline was increased by 13.9%, 16.3%, and 19.7% for subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), and severe (Child-Pugh Class C) hepatic impairment versus healthy subjects, respectively.
Danish: Det geometriske Cmax-gennemsnit for eravacyclin steg med hhv. 13,9 %, 16,3 % og 19,7 % hos patienter med let (Child-Pugh A), moderat (Child-Pugh B) og svært (Child-Pugh C) nedsat leverfunktion vs. raske forsøgspersoner.
English: Xerava is given by an infusion (drip) directly into your vein.
Danish: Xerava gives som infusionsvæske (drop) i en blodåre.
English: Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 12 hours at 25°C.
Danish: Der er påvist kemisk og fysisk brugsstabilitet efter fortynding i infusionsposen i 12 timer ved temperaturer på 25 °C.
English: If you miss a dose of Xerava
Danish: Hvis du har glemt en dosis
English: Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.
Danish: Kontakt lægen eller sundhedspersonalet med det samme, hvis du tror, at en dosis måske er glemt.
English: Antibiotic class adverse reactions include pseudomembranous colitis, and overgrowth of nonsusceptible organisms, including fungi (see section 4.4).
Danish: Klasseeffekter for antibiotika omfatter pseudomembranøs kolitis og kraftig vækst af ikke-følsomme organismer, herunder svampe (se pkt.
English: Animal studies have shown excretion of eravacycline and its metabolites in breast milk (see section 5.3).
Danish: Dyrestudier har vist, at eravacyclin og dets metabolitter udskilles i human mælk (se pkt.
English: The recommended dose regimen is 1 mg/kg eravacycline every 12 hours for 4 to 14 days.
Danish: Det anbefalede dosisregime er 1 mg/kg eravacyclin hver 12. time i 4-14 dage.
English: • Viridans Streptococcus spp.
Danish: • Streptococcus spp.
English: Eravacycline did affect mating and fertility in male rats at clinically relevant exposures (see section 5.3).
Danish: Eravacyclin havde indvirkning på parringen og fertiliteten hos hanrotter ved klinisk relevante eksponeringer (se pkt.
English: Eravacycline dosing
Danish: Eravacyclin-dosis
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: 1 VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON: 1 HÆTTEGLAS
English: Talk to your doctor or nurse if you are suffering from diarrhoea before being given Xerava.
Danish: Fortæl det til din læge eller sundhedspersonalet, hvis du har diarré, før du får Xerava.
English: In clinical trials in cIAI, there were no immunocompromised patients, and the majority of patients (80%) had APACHE II scores <10 at baseline; 5.4% of the patients had concurrent bacteraemia at baseline; 34% of the patients had complicated appendicitis.
Danish: I kliniske studier af komplicerede intraabdominale infektioner var der ingen immunkompromitterede patienter, og størstedelen af dem (80 %) havde APACHE II-scorer <10 ved baseline.
English: Number of vials to reconstitute
Danish: Antal hætteglas til rekonstitution
English: Pancreatitis has been reported with eravacycline and other tetracycline class antibiotics, and has been severe in some cases (see section 4.8).
Danish: Der er rapporteret om pankreatitis ved anvendelse af eravacyclin og andre antibiotika i tetracyclinklassen, i nogle tilfælde af svær grad (se pkt.
English: Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults (see sections 4.4 and 5.1).
Danish: Xerava er indiceret til behandling af komplicerede intraabdominale infektioner hos voksne (se pkt.
English: The increased exposure is not likely to be clinically significant; thus, no dose adjustment is required when eravacycline is co-administered with CYP3A inhibitors.
Danish: Det er således ikke nødvendigt at justere dosis, når eravacyclin administreres samtidig med CYP3A-hæmmere.
English: The geometric least square mean Cmax for eravacycline was increased by 8.8% for subjects with end stage renal disease (ESRD) versus healthy subjects with 90% CI -19.4, 45.2.
Danish: Det geometriske mindste kvadraters Cmax-gennemsnit for eravacyclin steg med 8,8 % hos patienter med terminal nyresygdom vs. raske forsøgspersoner ved 90 %KI -19,4;45,2).
English: The solution should not be used if particles are present or the solution is cloudy.
Danish: Opløsningen bør ikke anvendes, hvis der er synlige partikler i den, eller hvis den er grumset.
English: Dizziness may occur following administration of eravacycline (see section 4.8).
Danish: Svimmelhed kan forekomme efter administration af eravacyclin (se pkt.
English: The recommended dose regimen of Xerava is 1 mg/kg every 12 hours for 4 to 14 days.
Danish: Den anbefalede Xerava-dosis er 1 mg/kg hver 12. time i 4-14 dage.
English: Chemical and physical in-use stability after reconstitution in the vial has been demonstrated for 1 hour at 25°C.
Danish: Der er påvist kemisk og fysisk brugsstabilitet efter rekonstitution i hætteglasset i 1 time ved temperaturer på 25 °C.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed for cIAI that were susceptible to eravacycline in vitro:
Danish: I kliniske studier er der påvist effekt mod de patogener, der er anført for komplicerede intraabdominale infektioner, hvor der sås følsomhed for eravacyclin in vitro:
English: The eravacycline dose should be increased by approximately 50% (1.5 mg/kg IV q12h) when co-administered with rifampicin or other strong CYP3A inducers such as phenobarbital, carbamazepine, phenytoin and St. John's Wort (see sections 4.2 and 4.4).
Danish: Eravacyclin-dosis bør øges med ca. 50 % (1,5 mg/kg intravenøst hver 12. time) ved samtidig administration af rifampicin eller andre potente CYP3A-inducere som f.eks. phenobarbital, karbamazepin, phenytoin eller prikbladet perikon (se pkt.
English: • Breathing difficulties
Danish: • vejrtrækningsbesvær
English: How you will be given Xerava
Danish: Sådan vil du få Xerava
English: Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xerava.
Danish: Kontakt lægen eller sundhedspersonalet med det samme, hvis du tror, at du måske har fået for meget Xerava.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Danish: Saltsyre (til justering af pH)
English: General disorders and administration site conditions Infusion site reactionsc a. Thrombophlebitis includes the preferred terms thrombophlebitis and infusion site thrombosis b. Phlebitis includes the preferred terms phlebitis, infusion site phlebitis, superficial phlebitis and injection site phlebitis c. Infusion site reactions includes the preferred terms injection site erythema, infusion site hypoaesthesia,
Danish: Reaktioner på infusionsstedetc a. Tromboflebitis omfatter de foretrukne termer tromboflebitis og trombose ved infusionsstedet b. Flebitis omfatter de foretrukne termer flebitis, flebitis ved infusionsstedet, overfladisk flebitis og flebitis ved injektionsstedet c. Reaktioner på infusionsstedet omfatter de foretrukne termer erytem ved injektionsstedet, hypoæstesi ved infusionsstedet, erytem ved indstiksstedet og smerter ved indstiksstedet Beskrivelse af udvalgte bivirkninger
English: Xerava is a pale yellow to dark yellow cake in a 10mL glass vial.
Danish: Xerava er et bleggul til mørkegul kompakt pulver i et 10 ml-hætteglas.
English: What Xerava is and what it is used for What Xerava is
Danish: Virkning og anvendelse Hvad er Xerava?
English: Tell your doctor or nurse if you have any of these side effects.
Danish: Fortæl det til din læge eller sundhedspersonalet, hvis du bemærker en eller flere af disse bivirkninger.
English: In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in the pharmacokinetics of eravacycline were observed with respect to age.
Danish: I en farmakokinetisk populationsanalyse sås ingen klinisk relevante forskelle mellem ældre og yngre personer, hvad angår eravacyclins farmakokinetik.
English: Xerava should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 4.6).
Danish: Xerava bør ikke anvendes hos børn under 8 år, da tændernes misfarves (se pkt.
English: Each vial contains 50 mg eravacycline After reconstitution 1 mL contains 10 mg eravacycline.
Danish: Hvert hætteglas indeholder 50 mg eravacyclin Efter rekonstitution indeholder 1 ml opløsning 10 mg eravacyclin.
English: For patients weighing ≥ 40 kg - 49 kg:
Danish: For patienter med en legemsvægt på ≥ 40-49 kg:
English: Xerava must be reconstituted with water for injections and subsequently diluted using sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Xerava skal rekonstitueres med vand til injektionsvæsker og fortyndes derefter med natriumchloridvæske (9 mg/ml (0,9 %)) til injektion.
English: Infusion site reactions
Danish: Reaktioner på infusionsstedet
English: The geometric least square mean AUC0-inf for eravacycline was decreased by 4.0% for subjects with ESRD versus healthy subjects with 90% CI -14.0, 12.3.
Danish: Det geometriske mindste kvadraters AUC0-inf-gennemsnit for eravacyclin faldt med 4,0 % hos patienter med terminal nyresygdom vs. raske forsøgspersoner ved 90 %-KI (-14,0-12,3).
English: Each vial is for single use only.
Danish: Hætteglassene er kun til engangsbrug.
English: Eravacycline, TP-498 and TP-6208 are not inhibitors of BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 or MATE2-K transporters.
Danish: Eravacyclin, TP-498 og TP-6208 er ikke hæmmere af transporterne BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 og MATE2-K. Metabolitterne TP-498 og TP-6208 er ikke hæmmere af P-gp in vitro.
English: Elderly (≥ 65 years old) No dose adjustment is required in elderly patients (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos ældre patienter (se pkt.
English: Therefore, such patients should be monitored for adverse reactions (see Section 4.8), particularly if these patients are obese and/or are also being treated with strong CYP3A inhibitors where the exposure may be further increased (see sections 4.5 and 5.2).
Danish: 4.8), navnlig hvis de er overvægtige og/eller samtidig behandles med potente CYP3A-hæmmere, hvilket kan øge eksponeringen yderligere (se pkt.
English: Seek urgent medical attention if you suspect you have an anaphylactic reaction whilst receiving Xerava.
Danish: Søg straks lægehjælp, hvis du tror, at du oplever en anafylaktisk reaktion under behandlingen med Xerava.
English: • Abnormal blood test results for liver
Danish: • unormale blodtal i leverfunktionstest.
English: Pale yellow to dark yellow cake.
Danish: Bleggult til mørkegult kompakt pulver.
English: Tell your doctor or nurse if you notice any of these side effects during your treatment with Xerava.
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du får en eller flere af disse bivirkninger under behandlingen med Xerava.
English: No adverse effects on mating or fertility were observed in female rats.
Danish: Der sås ingen negativ påvirkning af parring eller fertiliteten hos hunrotter.
English: • Inflammation of the pancreas which causes severe pain in the abdomen or back (pancreatitis)
Danish: • betændelse i bugspytkirtlen, som kan medføre kraftige smerter i maven eller ryggen
English: Each vial contains 50 mg of eravacycline.
Danish: Hvert hætteglas indeholder 50 mg eravacyclin.
English: If you are given more Xerava than you should
Danish: Hvis du har fået for meget Xerava
English: MIC Breakpoints (µg/mL) Susceptible (S ≤)
Danish: MIC-grænseværdier (µg/ml)
English: Xerava 50 mg powder for concentrate eravacycline
Danish: Xerava 50 mg pulver til koncentrat eravacyclin i.v.
English: Patient weight (kg)
Danish: Patientens vægt
English: Tetracycline class effects
Danish: Klasseeffekter for tetracycliner
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 250 mL infusion bag.
Danish: Beregn den ønskede mængde rekonstitueret opløsning ud fra patientens vægt, og injicér opløsningen i en 250 mlinfusionspose.
English: For patients weighing 50 kg - 100 kg:
Danish: For patienter med en legemsvægt på 50-100 kg:
English: Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately.
Danish: Når pulveret er blevet blandet med vand og fortyndet, bør du få infusionsvæsken med det samme.
English: For administration, the reconstituted solution must be further diluted using sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Inden administration skal den rekonstituerede opløsning fortyndes yderligere med en natriumchloridvæske (9 mg/ml (0,9 %)) til injektion.
English: Xerava 50 mg powder for concentrate for solution for infusion eravacycline
Danish: Xerava 50 mg pulver til koncentrat til infusionsvæske, opløsning eravacyclin
English: After reconstitution each mL contains 10 mg eravacycline.
Danish: Efter rekonstitution indeholder 1 ml opløsning 10 mg eravacyclin.
English: Infusion-site erythema, pain/tenderness, phlebitis and thrombophlebitis were observed with intravenous eravacycline in clinical trials (see section 4.8).
Danish: I kliniske studier er der observeret erytem, smerter/ømhed, flebitis og tromboflebitis ved infusionsstedet (se pkt.
English: If the same intravenous line is used for sequential infusion of several different medicinal products, the line should be flushed before and after infusion with sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Hvis den samme intravenøse slange anvendes til sekventiel infusion af flere forskellige lægemidler, skal den skylles med en natriumchloridvæske (9 mg/ml (0,9 %)) til injektion.
English: For patients weighing >100 kg:
Danish: For patienter med en legemsvægt på> 100 kg:
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 100 mL infusion bag.
Danish: Beregn den ønskede mængde rekonstitueret opløsning ud fra patientens vægt, og injicér opløsningen i en 100 mlinfusionspose.
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 500 mL infusion bag.
Danish: Beregn den ønskede mængde rekonstitueret opløsning ud fra patientens vægt, og injicér opløsningen i en 500 mlinfusionspose.
English: The reconstituted solution will be withdrawn from the vial and added to an infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection in the hospital.
Danish: Det rekonstituerede koncentrat trækkes op af hætteglasset og tilsættes en infusionspose med natriumchloridinfusionsvæske (9 mg/ml (0,9 %)) (foregår på hospitalet).
English: Xerava 50 mg powder for concentrate for solution for infusion
Danish: Xerava 50 mg pulver til koncentrat til infusionsvæske, opløsning
English: Powder for concentrate for solution for infusion 1 vial.
Danish: Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas.
English: If the same intravenous line is used for sequential infusion of different medicinal products, the line should be flushed before and after infusion with sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Hvis den samme intravenøse slange anvendes til sekventiel infusion af forskellige lægemidler, skal den skylles med en natriumchloridvæske (9 mg/ml (0,9 %)) til injektion.
English: Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see sections 4.4, 4.5 and 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat leverfunktion (se pkt.
English: Xerava should not be used during tooth development (during the 2nd and 3rd trimester of pregnancy,
Danish: Xerava bør ikke anvendes i tandudviklingsperioden (dvs. i 2. og 3. graviditetstrimester og hos børn under 8 år), da det kan forårsage permanent misfarvning af tænderne (fra gullig til gråbrun) (se pkt.
English: Component of a multipack, can't be sold seperately.
Danish: Sælges ikke separat.
English: Mannitol (E421)
Danish: Mannitol (E421) Natriumhydroxid (til justering af pH)
English: Nordimet received a marketing authorisation valid throughout the EU on 18 August 2016.
Danish: Nordimet fik en markedsføringstilladelse med gyldighed i hele EU den 18. august 2016.
English: Nordimet should be injected under the skin once a week on the same day each week.
Danish: Nordimet bør injiceres under huden én gang ugentligt på samme ugedag.
English: Further information on Nordimet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nordimet.
Danish: Yderligere information om Nordimet findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/nordimet.
English: It must not be used if the patient is pregnant, breastfeeding or is receiving live vaccines.
Danish: Det må ikke anvendes, hvis patienten er gravid, ammer eller får levende vacciner.
English: Nordimet (methotrexate)
Danish: Nordimet (methotrexat)
English: Other information about Nordimet
Danish: Andre oplysninger om Nordimet
English: As for all medicines, data on the use of Nordimet are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Nordimet løbende overvåget.
English: The dose injected each week depends on which condition it is being used for and how well the treatment is working and, for children, on the child's height and weight.
Danish: Den ugentlige injicerede dosis afhænger af, hvilken tilstand den anvendes mod, hvor godt behandlingen virker, og, for så vidt angår børn, barnets højde og vægt.
English: The company that markets Nordimet will send out follow-up questionnaires for dosing errors that result in overdose.
Danish: Virksomheden, der markedsfører Nordimet, vil udsende opfølgende spørgeskemaer vedrørende doseringsfejl, der medfører overdosis.
English: Nordimet is a ‘hybrid medicine'.
Danish: Nordimet er et "hybridlægemiddel".
English: It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Danish: Det bør kun ordineres af læger med ekspertise i brugen af methotrexat og et grundigt kendskab til risiciene ved methotrexatbehandling.
English: What measures are being taken to ensure the safe and effective use of Nordimet?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nordimet?