FrancophonIA/ELRC3.0 huggingface dataset:
English: Before use, remove the vial containing the lyophilized powder of Xiapex and the vial containing the diluent for reconstitution from the refrigerator and allow the two vials to stand at room temperature for at least 15 minutes and no longer than 60 minutes.
Danish: Før brug skal hætteglasset med det frysetørrede pulver med Xiapex og hætteglasset med solvens til rekonstitution tages ud af køleskabet, og de to hætteglas skal stå ved stuetemperatur i mindst 15 minutter og ikke længere end 1 time.
English: The vial containing Xiapex and the vial containing the solvent for solution for injection for reconstitution must be refrigerated.
Danish: Hætteglasset med Xiapex og hætteglasset med solvens til injektionsvæske til rekonsitution skal være afkølet.
English: 12 or 13 mm needle (not supplied), withdraw a volume of 0.25 ml of reconstituted solution
Danish: 27 gauge 12 eller 13 mm kanyle (medfølger ikke), trækkes der et volumen på 0,25 ml rekonstitueret injektionsvæske op (der indeholder 0,58 mg Xiapex).
English: Dupuytren's PIP joints
Danish: Dupuytrens PIP-led
English: The white lyophilized powder is supplied in a 3 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap.
Danish: Det hvide, frysetørrede pulver fås i et 3 ml type I klart hætteglas med gummiprop, aluminiumforsegling og flip-off plastikhætte.
English: Until advised by your doctor, do not flex or extend the fingers of the injected hand.
Danish: De må ikke bøje eller udstrække fingrene på den behandlede hånd, før det tilrådes af Deres læge.
English: • scrotal redness, swelling and pain
Danish: • rødme, hævelse og smerter i pungen
English: Injection site reaction, malaise, irritation, anaesthesia, desquamation, nodule or discoloration Cold intolerance of the treated fingers
Danish: Reaktioner ved injektionsstedet, ubehag, irritation, anæstesi, afskalning, knuder eller misfarvning
English: Each vial of powder contains 0.9 mg of collagenase clostridium histolyticum*.
Danish: Hvert hætteglas med pulver indeholder 0,9 mg kollagenase clostridium histolyticum*.
English: Xiapex is used for the treatment of two different conditions: Dupuytren's contracture in adult patients with a palpable cord and Peyronie's disease in adult men.
Danish: Xiapex anvendes til behandling af to forskellige sygdomme: Dupuytrens kontraktur (kuskehånd)
English: Procedural pain Fracture of penis Skin laceration
Danish: Penisfraktur Rifter i huden Åbne sår
English: Hypertension
Danish: Hyperæstesi
English: Tendon rupture Ligament injury Limb injury Open wound Wound dehiscence
Danish: Rifter i hudena,b Seneruptur Ligamentskade Skade på ekstremiteter Åbne sår
English: • breathing trouble
Danish: • vejrtrækningsbesvær
English: For cords affecting the PIP joint, the finger extension procedure should be performed when the MP joint is in the flexed position.
Danish: For strenge, der påvirker PIP-leddet, skal manipulationen af fingeren udføres, mens MP-leddet er bøjet.
English: Do not invert the vial or shake the solution.
Danish: Vend ikke hætteglasset på hovedet og ryst ikke injektionsvæsken.
English: • constipation
Danish: • varmefølelse
English: How to store Xiapex
Danish: Sådan får De Xiapex
English: Baseline, mean (SD) Day 31, mean (SD) Change, mean (SD) % Change, mean (SD)
Danish: Ændring, gennemsnit (SD) % ændring, gennemsnit (SD)
English: MP Jointsa
Danish: MP leda
English: 3 ml solution is supplied in a 5 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap.
Danish: 3 ml opløsning fås i et 5 ml type I klart hætteglas med gummiprop, aluminiumsforsegling og flip-off plastikhætte.
English: Using a 1 ml syringe with 0.01 ml graduations with a 27-gauge 12-13 mm needle (not supplied), withdraw the correct volume of the diluent supplied:
Danish: Med en 1 ml injektionssprøjte med 0,01 ml gradueringer og en 27 gauge 12-13 mm kanyle (medfølger ikke) trækkes det korrekte volumen af tilhørende solvens op:
English: Each powder vial contains 0.9 mg collagenase clostridium histolyticum
Danish: Hvert hætteglas med pulver indeholder 0,9 mg kollagenase clostridium histolyticum
English: Finger extension procedure
Danish: Manipulation af fingeren
English: b Includes: injection site swelling, penile oedema, penile swelling, local swelling, scrotal swelling,
Danish: b Omfatter: hævelse ved injektionsstedet, penilt ødem, hævelse af penis, lokal hævelse, hævelse af skrotum og ødemer på injektionsstedet.
English: Sexual dysfunction Scrotal erythema Genital discomfort Genital haemorrhage Pelvic pain
Danish: Penile forstyrrelser Progression af Peyronies sygdom Seksuel dysfunktion Erytem på skrotum Genitalt besvær
English: Skin disorder, nodule, granuloma, blister, irritation or oedema
Danish: Hudgener, knude, granulom, blister, irritation eller ødem Pigmentforandring Hyperpigmentering af hud
English: Elevate the injected hand as much as possible until the day after the finger extension procedure.
Danish: Efter udstrækning af fingeren skal De holde den behandlede hånd opad så meget som muligt indtil dagen efter.
English: Questionnaire (PDQ)
Danish: (Peyronie's Disease Questionnaire, PDQ)
English: Alanine aminotransferase increased Aspartate aminotransferase increased Body temperature increased
Danish: Palpable lymfeknuder Øget alaninaminotransferase
English: • reactions at the site of injection including peeling of the skin, skin discolouration, infection, pain, skin tightness, numbness, irritation or nodules, scab, wound
Danish: • reaktioner på injektionsstedet herunder afskalning af hud, misfarvning af huden, infektion,
English: • lymph node pain and swollen lymph nodes
Danish: • smerte i lymfeknuder og hævede lymfeknuder
English: • rupture of a tendon, ligament injury
Danish: • seneruptur, ligamentskade
English: • penis disorder
Danish: • penissygdom
English: Influenza like illness Oedema
Danish: Influenzalignende sygdom Ødem
English: A single-use syringe containing 0.01-ml graduations with a permanently fixed 27-gauge 12 or 13 mm needle (not supplied) should be used to withdraw the volume of reconstituted solution.
Danish: En injektionssprøjte til engangsbrug med 0,01 ml gradueringer med en permanent fastgjort 27 gauge 12 eller 13 mm kanyle (medfølger ikke) bør anvendes til at trække volumen af den rekonstituerede injektionsvæske op. Der vil være en lille mængde rekonstitueret injektionsvæske tilbage i hætteglasset.
English: f) The reconstituted Xiapex solution can be kept at room temperature (20º to 25ºC) for up to one hour or refrigerated at 2º to 8°C for up to 4 hours prior to administration.
Danish: f) Rekonstituerede Xiapex-injektionsvæske kan opbevares ved stuetemperatur (20 ºC-25 ºC) i op til en time, eller i køleskab ved 2 ºC til 8 °C i op til 4 timer før administration.
English: The vial containing the solution should not be inverted or shaken.
Danish: Hætteglasset med injektionsvæske må ikke vendes rundt eller rystes.
English: Breast tenderness Hypertrophy breast
Danish: Ømhed i brystet Brysthypertrofi
English: Do not attempt to disrupt the injected cord by self manipulation at any time.
Danish: Forsøg ikke at sprænge den streng, der er indsprøjtet i, ved selv at udstrække fingeren på noget som helst tidspunkt.
English: Use caution with cords as they approach the PIP flexion crease area.
Danish: Vær forsigtig med strenge som er tæt på PIP palmar digital bøjefuren.
English: The symptoms of musculoskeletal syndrome could be joint or muscle pain, shoulder stiffness, hand swelling, fibrosis of the palms, and thickening or nodule forming of tendons.
Danish: Hvis De bemærker nogen af følgende tegn og symptomer, bør De sige det til Deres læge: led- eller muskelsmerter, skulderstivhed, hævelse af hånden, fortykkelse og/eller fremkomst af små knuder i sener.
English: • increased perspiration
Danish: • øget svedproduktion
English: Dupuytren's MP joints
Danish: Dupuytrens MP-led
English: B. PACKAGE LEAFLET
Danish: Baselinea Referenceb
English: • rash, eczema
Danish: • udslæt, eksem
English: • tenderness in ligament at base of penis
Danish: • ømhed i ledbåndet ved roden af penis
English: ∗ reported from a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture.
Danish: * rapporteret fra et klinisk studie efter markedsføring hos en patient med tidligere eksponering for
English: Reconstituted Xiapex can be kept at ambient room temperature (20ºC-25ºC) for up to one hour or refrigerated at 2ºC-8˚C for up to 4 hours prior to administration.
Danish: Rekonstitueret Xiapex kan opbevares ved stuetemperatur (20 °C-25 °C) i op til en time eller i køleskab ved 2 °C-8 °C i op til 4 timer før administration.
English: • The summary of product characteristics and the patient information leaflet.
Danish: • Produktresumé og indlægsseddel
English: Instructions on how to gently straighten your penis Gently straighten your penis one time a day.
Danish: Ret forsigtigt Deres penis ud 1 gang om dagen.
English: The reconstituted Xiapex solution can be kept at room temperature (20º to 25ºC) for up to one hour or refrigerated at 2º to 8°C for up to 4 hours prior to administration.
Danish: Den rekonstituerede Xiapex-injektionsvæske kan opbevares ved stuetemperatur (20 ºC-25 ºC) i op til en time, eller i køleskab ved 2 ºC til 8 °C i op til 4 timer før administration.
English: Headache Dizziness Dysgeusia Paraesthesia Burning sensation Hyperaesthesia Hypoaesthesia
Danish: Brændende fornemmelse Hyperæstesi
English: Renal impairment
Danish: Ødemer periferec
English: Oedema peripheralc Injection site haemorrhage, pain or swelling Tenderness
Danish: Blødning ved injektionsstedet, smerte eller hævelse Ømhed
English: • genital discomfort and bruising
Danish: • utilpashed fra kønsdele og blå mærker
English: Abdominal distension Constipation
Danish: Udspilet abdomen Forstoppelse
English: • dizziness
Danish: • ømhed
English: • chest pain
Danish: • bækkensmerter
English: Pain in extremity Arthralgia Axillary mass
Danish: Artralgi Aksillær masse Hævede led Myalgi
English: Due to the lack of quantifiable systemic exposure of Xiapex in patients with Dupuytren's contracture and minimal and short-lived systemic exposure of Xiapex in patients with Peyronie's disease, no dose adjustment is necessary.
Danish: Der er ingen kvantificerbar systemisk eksposition efter en enkelt injektion af Xiapex hos patienter med Dupuytrens kontraktur, og kun en minimal eller kortvarig systemisk eksposition for Xiapex hos patienter med Peyronies sygdom.
English: • water retention
Danish: Opbevaring
English: • purple bruising and swelling of your penis
Danish: • blåsorte mærker og hævelse af penis
English: 0.9 mg of collagenase clostridium histolyticum.
Danish: Hvert hætteglas Xiapex indeholder 0,9 mg kollagenase clostridium histolyticum.
English: The company withdrew the application on 29 October 2019.
Danish: Virksomheden trak ansøgningen tilbage den 29. oktober 2019.
English: In addition, more data were needed to show that the quality of the medicine is consistent.
Danish: Derudover var der behov for flere oplysninger for at vise, at kvaliteten af lægemidlet er konsistent.
English: What did the Agency recommend at that time?
Danish: Hvad anbefalede agenturet på daværende tidspunkt?
English: As a result, bacteria cannot multiply and they die.
Danish: Som følge heraf kan bakterierne ikke formere sig, og de dør.
English: The Agency considered that the two studies presented did not show convincingly that the medicine was effective.
Danish: Agenturet vurderede, at de to fremlagte studier ikke i overbevisende grad påviste, at lægemidlet var effektivt.
English: What is Linhaliq and what was it intended to be used for?
Danish: Hvad er Linhaliq, og hvad forventedes det anvendt til?
English: How does Linhaliq work?
Danish: Hvordan virker Linhaliq?
English: The company presented the results of two studies in a total of 582 patients with non-cystic fibrosis bronchiectasis.
Danish: Virksomheden fremlagde resultaterne af to studier hos i alt 582 patienter med non-cystisk-fibrosebronkiektasi.
English: Fluoroquinolones work by preventing bacteria from making copies of their DNA (genetic material).
Danish: Fluoroquinoloner virker ved at forhindre bakterier i at lave kopier af deres DNA (genetisk materiale).
English: This was intended to slow down the medicine's release into the lungs, allowing it to act for longer.
Danish: Formålet med dette var, at lægemidlet skulle frigives langsommere i lungerne og dermed virke i længere tid.
English: The application was withdrawn after that the European Medicines Agency had evaluated the information from the company and prepared questions for the company.
Danish: Ansøgningen blev trukket tilbage, efter at Det Europæiske Lægemiddelagentur havde vurderet den dokumentation, som virksomheden havde fremlagt, og udarbejdet spørgsmål til virksomheden.
English: Therefore, at the time of the withdrawal, the Agency's opinion was that the benefits of Linhaliq did not outweigh its risks.
Danish: Derfor var agenturet på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Linhaliq ikke opvejede risiciene.
English: Withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin) EMA/610519/2019
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Linhaliq (ciprofloxacin) EMA/610519/2019
English: In each study Linhaliq was compared with placebo (a dummy treatment).
Danish: I begge studier blev Linhaliq sammenlignet med placebo (en uvirksom behandling).
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it decided to withdraw its application because the data provided do not allow EMA's committee for human medicines to conclude on a positive benefit-risk balance for the medicine.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak ansøgningen tilbage, fordi de fremlagte data ikke gjorde det muligt for EMA's Udvalg for Lægemidler til Mennesker at konkludere, at benefit/risk-forholdet for lægemidlet var positivt.
English: Does this withdrawal affect patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske studier eller i programmer for anvendelse med særlig udleveringstilladelse?
English: Withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Linhaliq (ciprofloxacin)
English: The company had responded to the last round of questions, and the Agency was completing its assessment of the responses at the time of the withdrawal.
Danish: Virksomheden havde svaret på den sidste spørgsmålsrunde, og agenturet var i gang med at vurdere virksomhedens svar på spørgsmålene, da ansøgningen blev trukket tilbage.
English: Linhaliq was developed for patients with ‘non-cystic fibrosis bronchiectasis', which means it was not intended for patients with bronchiectasis due to cystic fibrosis.
Danish: Linhaliq blev udviklet til patienter med "non-cystisk-fibrose-bronkiektasi", hvilket vil sige, at det ikke var rettet mod patienter med bronkiektasi forårsaget af cystisk fibrose.
English: The active substance in Linhaliq, ciprofloxacin, is an antibiotic belonging to a group called fluoroquinolones.
Danish: Det aktive stof i Linhaliq, ciprofloxacin, er et antibiotikum, der tilhører gruppen af fluoroquinoloner.
English: In Linhaliq, some of the active substance is enclosed in tiny fat particles called liposomes.
Danish: I Linhaliq er en del af det aktive stof indkapslet i bittesmå fedtpartikler kaldet liposomer.
English: The company informed the Agency that there are no ongoing clinical trials or compassionate use programmes with Linhaliq.
Danish: Virksomheden har til agenturet oplyst, at der aktuelt ikke gennemføres kliniske studier eller programmer for anvendelse med særlig udleveringstilladelse for Linhaliq.
English: Bronchiectasis is a long-term condition in which the airways have widened and become flabby and scarred, with a build-up of mucus.
Danish: Bronkiektasi er en langvarig lidelse, hvor luftvejene har udvidet sig og er blevet slappe og arrede, og hvor der akkumuleres slim.
English: Linhaliq contains the active substance ciprofloxacin and was to be available for inhalation using an inhaler device.
Danish: Linhaliq indeholder det aktive stof ciprofloxacin, og det skulle inhaleres ved hjælp af en inhalator.
English: Based on the review of the data, at the time of the withdrawal, the Agency had several concerns and its provisional opinion was that Linhaliq could not have been authorised for treating or preventing flare-ups in adults with non-cystic fibrosis bronchiectasis who have long-term lung infection with Pseudomonas aeruginosa.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde agenturet visse betænkeligheder og var af den foreløbige opfattelse, at Linhaliq ikke kunne være blevet godkendt til behandling eller forebyggelse af opblussen af non-cystisk-fibrose-bronkiektasi hos voksne med langvarig lungebetændelse forårsaget af Pseudomonas aeruginosa.
English: The main measure of effectiveness was the time it took until patients had a flare-up of bronchiectasis.
Danish: Virkningen blev hovedsagelig bedømt på, hvor lang tid der gik, før patienternes bronkiektasi blussede op.
English: Aradigm Pharmaceuticals Limited withdrew its application for a marketing authorisation of Linhaliq for treating and preventing flare-ups of bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria.
Danish: Aradigm Pharmaceuticals Limited har tilbagetrukket sin ansøgning om markedsføringstilladelse for Linhaliq til behandling og forebyggelse af opblussen af bronkiektasi hos patienter med langvarig lungebetændelse forårsaget af Pseudomonas aeruginosa-bakterien.
English: Linhaliq was developed as a medicine for preventing and reducing exacerbations (flare-ups) of bronchiectasis in adults who have long-term lung infection with Pseudomonas aeruginosa bacteria.
Danish: Linhaliq blev udviklet som et lægemiddel til forebyggelse og reduktion af forværring (opblussen) af bronkiektasi hos voksne med langvarig lungebetændelse forårsaget af Pseudomonas aeruginosabakterien.
English: Protection lasts for one year.
Danish: Beskyttelsen varer i 1 år.
English: For booster vaccination a single injection is given every year.
Danish: Ved booster-vaccination gives en enkelt injektion én gang om året.
English: In all studies the vaccinated sheep and cattle were compared with unvaccinated animals (controls).
Danish: I alle undersøgelserne blev de vaccinerede får og kvæg sammenlignet med ikke-vaccinerede dyr (kontrolemner).
English: The most common side effect with Bovilis Blue-8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.
Danish: De hyppigste bivirkninger ved Bovilis Blue-8 (som kan forekomme hos op til 1 ud af 10 dyr) er øget kropstemperatur med mellem 0,5 og 1,0 ˚C, som varer i højest 1-2 dage.
English: The full EPAR for Bovilis Blue-8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Bovilis Blue-8 findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age.
Danish: Vaccinens virkning blev undersøgt i forbindelse med en række laboratorieundersøgelser af får og kvæg i den anbefalede minimumsalder.
English: The European Commission granted a marketing authorisation valid throughout the EU for Bovilis Blue-8 on 21 November 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bovilis Blue-8 den 21/11/2017.
English: This medicine is the same as Bluevac BTV8, which is already authorised in the EU.
Danish: Lægemidlet er identisk med Bluevac BTV8, som allerede er godkendt i EU.
English: The withdrawal period for meat and milk from cattle and sheep treated with Bovilis Blue-8 is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra kvæg og får, der behandles med Bovilis Blue-8, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The first injection is given from two and a half months of age and a second injection is given three weeks later.
Danish: Den første injektion gives, når dyret er 2,5 måned gammelt, og den anden injektion gives tre uger senere.
English: This is a summary of the European public assessment report (EPAR) for Bovilis Blue-8.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bovilis Blue-8.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovilis Blue-8's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Bovilis Blue-8 opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The company that makes Bluevac BTV8 has agreed that its scientific data can be used for Bovilis Blue-8 (‘informed consent').
Danish: Den virksomhed, som fremstiller Bluevac BTV8, har indvilget i, at dens videnskabelige oplysninger må anvendes for Bovilis Blue-8 (informeret samtykke).
English: Bovilis Blue-8 is a vaccine.
Danish: Bovilis Blue-8 er en vaccine.
English: This authorisation was based on the authorisation granted to Bluevac BTV8 in 2011 (‘informed consent').
Danish: Denne tilladelse byggede på den tilladelse, som blev udstedt for Bovilis Blue-8 i 2011 ("informeret samtykke").
English: The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection.
Danish: Det primære mål for virkning for vaccinen var viræmi (niveauet af BTV8 i blodet) og kliniske tegn på bluetonguevirus-infektion.
English: Bovilis Blue-8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Danish: Bovilis Blue-8 indeholder en bluetonguevirus, der er blevet inaktiveret, så den ikke kan fremkalde sygdommen.
English: Bovilis Blue-8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Danish: Bovilis Blue-8 anvendes til får og kvæg for at beskytte dem mod sygdommen bluetongue, som er en infektion, der forårsages af bluetonguevirus, som overføres gennem mitter.
English: The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.
Danish: Undersøgelserne viste, at vaccinen forebygger viræmi hos får og kvæg og reducerer de kliniske tegn hos får, der er smittet med bluetonguevirus, serotype 8.
English: bluetongue virus vaccine, serotype 8 (inactivated)
Danish: Vaccine mod bluetonguevirus, serotype 8 (inaktiveret)
English: It is not intended to provide practical advice on how to use Bovilis Blue-8.
Danish: Det er ikke en praktisk vejledning i, hvordan Bovilis Blue-8 bør anvendes.
English: For the full list of restrictions and all side effects reported with Bovilis Blue-8, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og indberettede bivirkninger ved Bovilis Blue-8 fremgår af indlægssedlen.
English: Bovilis Blue-8 contains bluetongue viruses of one type (‘serotype 8').
Danish: Bovilis Blue-8 indeholder én type bluetonguevirus ("serotype 8").
English: The vaccine contains inactivated (killed) bluetongue virus, serotype 8.
Danish: Vaccinen indeholder inaktiveret (dræbt) bluetonguevirus, serotype 8.
English: What is Bovilis Blue-8 and what is it used for?
Danish: Hvad er Bovilis Blue-8, og hvad anvendes det til?
English: What are the risks associated with Bovilis Blue-8?
Danish: Hvilke risici er der forbundet med Bovilis Blue-8?
English: Why is Bovilis Blue-8 approved?
Danish: Hvorfor blev Bovilis Blue-8 godkendt?