FrancophonIA/ELRC3.0 huggingface dataset:
English: • 2 sterile, disposable needles (27-gauge, ½-inch)
Danish: • 2 sterile engangskanyler (27-gauge, ½-inch)
English: With the other hand, take the syringe with the sterile water (solvent) and slowly insert the needle straight down through the centre of the rubber stopper of the Rilonacept Regeneron powder vial.
Danish: Med den anden hånd tages sprøjten med det sterile vand (solvens), og kanylen stikkes langsomt lige ned gennem midten på gummiproppen på hætteglasset med Rilonacept Regeneron pulveret.
English: With the needle cover on, pull back the plunger on the syringe to the mark that is equal to the volume of the solution that your doctor has prescribed for you to inject, filling the syringe with air (see Figure 9).
Danish: Med nålehætten på trækkes sprøjtens stempel tilbage til den markering, der svarer til den mængde opløsning, som Deres læge har ordineret til injektion, og der trækkes luft ind i sprøjten (se Figur 9).
English: Although neutropenia was observed uncommonly in CAPS patients, the numbers studied are small.
Danish: Der blev observeret neutropeni hos CAPS-patienter, men det var ikke almindeligt, og antallet af undersøgte patienter var ikke stort.
English: Rilonacept Regeneron is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older.
Danish: Rilonacept Regeneron er indikeret for behandling af kryopyrin-associerede periodiske syndromer (CAPS) med svære symptomer, herunder familiær kulde autoinflammatorisk syndrom (FCAS) og Muckle-Wells syndrom (MWS), hos voksne og børn i alderen 12 år og derover.
English: The dissolved Rilonacept Regeneron solution should be a thick, clear liquid, colourless to pale yellow.
Danish: Den opløste Rilonacept Regeneron opløsning bør være en farveløs til lysegul, tyk, klar væske.
English: During Part A of the pivotal study (see section 5.1), the incidence of patients reporting infections and considered by the investigator as related to treatment was greater with Rilonacept Regeneron (9%) than with placebo (0%).
Danish: 5.1) var incidensen af patienter, som indberettede infektioner, der af investigatoren blev anset som behandlingsrelateret, større med Rilonacept Regeneron (9 %) end med placebo (0 %).
English: Attach the needle securely to the syringe without removing the needle cover.
Danish: Sæt kanylen godt fast på sprøjten uden at fjerne kanylens hætte.
English: • one used for adding the sterile water (solvent) to the Rilonacept Regeneron powder
Danish: • en sprøjte til at tilføje det sterile vand (solvens) til Rilonacept Regeneron pulveret
English: 4 vials of powder for solution for injection 4 vials of solvent
Danish: 4 hætteglas med pulver til injektionsvæske, opløsning 4 hætteglas med solvens
English: Hold the vial in one hand and the syringe in the other hand and carefully turn the vial upside down so that the needle is pointing straight up.
Danish: Hold hætteglasset i den ene hånd, og sprøjten i den anden hånd, og vend forsigtigt hætteglasset på hovedet, så kanylen peger lige opad.
English: For small children or persons with little fat under the skin, you may need to hold the syringe and needle at a 45° angle (see Figure 13b).
Danish: Det kan være nødvendigt at holde sprøjten og kanylen i en 45° vinkel (se Figur 13b) hos små børn og personer, der kun har et lille fedtlag under huden.
English: • 8 sterile, 3-ml disposable syringes
Danish: • 8 sterile 3-ml engangssprøjter
English: Uncommon side effects (affects 1 to up to 10 users in 1,000)
Danish: Ikke almindelige bivirkninger (påvirker fra 1 op til 10 brugere ud af 1000)
English: • 1 gauze pad
Danish: • 1 gazebind
English: Do not use Rilonacept Regeneron:
Danish: Tag ikke Rilonacept Regeneron:
English: Turn the syringe so that the needle is facing straight up.
Danish: Drej sprøjten så kanylen peger lige opad.
English: Remove the vial from the syringe.
Danish: Fjern hætteglasset fra sprøjten.
English: • Do not reuse needles or syringes.
Danish: • Kanyler og sprøjter må ikke genbruges.
English: While holding the syringe at eye level, slowly pull the syringe plunger back to the 2.5-ml line so that the sterile water (solvent) moves from the vial into the syringe (see Figure 3).
Danish: Hold sprøjten i øjenhøjde, og træk langsomt sprøjtens stempel tilbage til markeringen med 2,5 ml, så det sterile vand (solvens) løber fra hætteglasset og ind i sprøjten (se Figur 3).
English: Age group (range)
Danish: Aldersgruppe (interval)
English: With the other hand gently pinch a fold of skin around the site that you cleaned for injection.
Danish: Med den anden hånd klemmes en hudfold forsigtigt sammen på det rengjorte injektionssted.
English: The concomitant use of Rilonacept Regeneron with other IL-1 inhibitors is not recommended (see section
Danish: Samtidig anvendelse af Rilonacept Regeneron og andre IL-1-hæmmere anbefales ikke (se pkt.
English: Do not use any vial of Rilonacept Regeneron more than one time.
Danish: Et hætteglas med Rilonacept Regeneron må ikke anvendes mere end én gang.
English: • one used for injection
Danish: • en sprøjte til injektionen
English: p-value for within group comparison of change from Baseline
Danish: Gennemsnitlig ændring fra baseline til endepunkt p-værdi for sammenligning af ændring fra baseline inden for gruppen
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 220 mg of rilonacept.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas med pulver indeholder 220 mg rilonacept.
English: • A puncture-resistant container for disposal of used needles, syringes, and vials
Danish: • En punkterfri beholder til bortskaffelse af brugte kanyler, sprøjter og hætteglas
English: Using aseptic technique, Rilonacept Regeneron powder should be reconstituted with 2.3 ml solvent (water for injections) prior to administration.
Danish: Ved hjælp af aseptisk teknik skal Rilonacept Regeneron-pulveret rekonstitueres med 2,3 ml solvens (vand til injektionsvæske) før administrering.
English: Attach the exposed top of the sterile water vial to the top of a syringe by twisting the syringe onto the vial of sterile water (solvent) (see Figure 2).
Danish: Fastgør den blotlagte top på hætteglasset med sterilt vand på toppen af sprøjten ved at dreje sprøjten fast på hætteglasset med sterilt vand (solvens) (se Figur 2).
English: ADRs to Rilonacept Regeneron reported during the Phase 2/3 program in a total of 109 patients, some treated for longer than 2 years, are listed below using the following categories of frequency: very common (≥1/10); common (≥ 1/100 to <1/10), uncommon (≥1/1000 to <1/100).
Danish: Følgende hyppighedsfrekvenser anvendes: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10) ikke almindelig (≥1/1.000 til <1/100).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING POWDER VIAL LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET PÅ HÆTTEGLAS MED PULVER
English: With your free hand hold the syringe near its base.
Danish: Hold fast på sprøjten tæt ved bunden med den frie hånd.
English: Using aseptic technique, the recommended dose volume, up to 2 ml (160 mg) of the solution should be withdrawn with a new 27-gauge, ½-inch injection needle attached to a new 3-ml syringe for subcutaneous injection.
Danish: Ved at anvende en aseptisk teknik, skal det anbefalede dosisvolumen på op til 2 ml (160 mg) af opløsningen trækkes op med en ny 27-gauge, ½-inch injektionskanyle, som er sat på en ny 3-ml sprøjte til subkutan injektion.
English: Other medicines and Rilonacept Regeneron Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig, eller overvejer at bruge anden medicin.
English: If you have any questions about how Rilonacept Regeneron works or why this medicine has been prescribed for you, ask your doctor.
Danish: Spørg Deres læge hvis De har nogle spørgsmål om, hvordan Rilonacept Regeneron virker, eller hvorfor De har fået ordineret dette lægemiddel.
English: Remove the syringe and needle from the stopper and throw away the syringe attached to the needle and sterile water (solvent) vial in the puncture-resistant container.
Danish: Sprøjten og kanylen fjernes fra proppen, og sprøjten, der sidder på kanylen, og hætteglasset med det sterile vand (solvens) bortskaffes i den punkterfri beholder.
English: INSTRUCTIONS FOR USE OF RILONACEPT REGENERON POWDER FOR SOLUTION FOR INJECTION
Danish: BRUGSVEJLEDNING TIL OPLØSNING AF RILONACEPT REGENERON PULVER TIL INJEKTIONSVÆSKE
English: 45.5 to 49.0 49.1 to 52.6 52.7 to 56.3 56.4 to 59.9 60.0 to 63.5 63.6 to 67.2 67.3 to 70.8 70.9 or greater
Danish: 52,7 til 56,3
English: Thus it is expected that for a molecule that binds to IL-1, such as rilonacept, the formation of CYP450 enzymes could be normalized.
Danish: Derfor forventes det, at dannelsen af CYP450-enzymer kan normaliseres efter administration af et molekyle, der binder til IL-1, såsom rilonacept.
English: Each vial of powder contains 220 mg rilonacept.
Danish: Hvert hætteglas med pulver indeholder 220 mg rilonacept.
English: General guidelines when giving a Rilonacept Regeneron injection:
Danish: Generelle retningslinjer for injektion af Rilonacept Regeneron:
English: Remove the needle, discard the syringe and needle.
Danish: Kanylen fjernes, og sprøjten samt kanylen bortskaffes.
English: • 8 sterile, disposable needles (27-gauge, ½-inch)
Danish: • 8 sterile engangskanyler (27-gauge, ½-inch)
English: Rilonacept Regeneron is for subcutaneous use only.
Danish: Rilonacept Regeneron er kun til subkutan anvendelse.
English: Neutropenia (absolute neutrophil count [ANC] < 1.5 x 109/l) has been observed commonly with another medicinal product that inhibits IL-1 used in a patient population (rheumatoid arthritis) other than CAPS.
Danish: 9/l) er hyppigt observeret ved anvendelse af et andet lægemiddel, der hæmmer IL-1, i en anden patientpopulation (reumatoid artritis) end CAPS.
English: Rilonacept Regeneron is intended for subcutaneous use.
Danish: Rilonacept Regeneron er kun beregnet til subkutan brug.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget fra krav om blindeskrift.
English: Other sources of information
Danish: Anden information
English: Prior to injection, the reconstituted solution should be carefully inspected for any discolouration or particulate matter.
Danish: Før injektion skal den rekonstituerede opløsning inspiceres nøje for at se, om der er misfarvning eller partikler i opløsningen.
English: Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection rilonacept
Danish: Rilonacept Regeneron 80 mg/ml pulver og solvens til injektionsvæske, opløsning rilonacept
English: Prior to injection, the solution should be carefully inspected for any discolouration or particulate matter.
Danish: Før injektion skal opløsningen inspiceres nøje, for at se om der er misfarvning eller partikler i opløsningen.
English: • 4 vials of Rilonacept Regeneron powder
Danish: • 4 hætteglas med Rilonacept Regeneron pulver
English: NAME OF THE MEDICINAL PRODUCT Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection.
Danish: LÆGEMIDLETS NAVN Rilonacept Regeneron 80 mg/ml pulver og solvens til injektionsvæske, opløsning.
English: Keep out of the sight and reach of children.
Danish: Opbevares uden for børns syns- og rækkevidde.
English: Keep the puncture-resistant container out of reach of children.
Danish: Den punkterfri beholder skal opbevares utilgængeligt for børn.
English: What you need to know before you use Rilonacept Regeneron
Danish: Det skal De vide, før De begynder at tage Rilonacept Regeneron
English: Do not throw any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Table 5: Rilonacept steady-state pharmacokinetic properties1
Danish: Tabel 5: Steady state farmakokinetiske egenskaber af rilonacept Parameter
English: Do not throw away vials, needles, or syringes in the household rubbish.
Danish: Hætteglas, kanyler og sprøjter må ikke smides i skraldespanden.
English: Open a wrapper containing a new, disposable syringe.
Danish: Åbn en indpakning med en ny, steril engangskanyle.
English: Baseline Mean KSS
Danish: Baseline Gennemsnitlig KSS
English: - fever lasting longer than 3 days, or any other symptoms possibly related to an infection, such as prolonged cough, prolonged headache or localised redness, warmth or swelling of your skin.
Danish: De skal straks fortælle det til Deres læge, hvis De udvikler symptomer på en infektion, mens De behandles med Rilonacept Regeneron, såsom: - langvarig feber, dvs. feber som varer mere end 3 dage, eller andre symptomer med mulig forbindelse til en infektion, såsom langvarig hoste, langvarig hovedpine eller lokaliseret rødmen, varme eller hævelse af huden.
English: LIST OF EXCIPIENTS Also contains: glycine, arginine hydrochloride, histidine, histidine hydrochloride monohydrate polyethylene glycol 3350, sucrose PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også: glycin, argininhydrochlorid, histidin, histidinhydrochloridmonohydrat, polyethylenglycol 3350, sakkarose, og vand til injektionsvæske.
English: • 1 vial of Rilonacept Regeneron powder
Danish: • 1 hætteglas med Rilonacept Regeneron pulver
English: Keep Rilonacept Regeneron away from light.
Danish: Rilonacept Regeneron skal beskyttes mod lys.
English: Hypertension, flushing
Danish: Hypertension, rødmen almindelig
English: Hepatic impairment Rilonacept Regeneron has not been studied in patients with hepatic impairment.
Danish: Nedsat leverfunktion Rilonacept Regeneron er ikke blevet undersøgt hos patienter med nedsat leverfunktion.
English: The reconstituted solution is viscous, clear and colourless to pale yellow.
Danish: Den rekonstituerede opløsning er viskøs, klar og farveløs til lysegul.
English: - The other ingredients in the powder are glycine, arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polyethylene glycol 3350 and sucrose.
Danish: - Øvrige indholdsstoffer i pulveret: Glycin, argininhydrochlorid, histidin, histidinhydrochloridmonohydrat, polyethylenglycol 3350 og sakkarose.
English: STEP 6: Giving the injection Rilonacept Regeneron is injected into the tissue directly below the layers of skin.
Danish: Rilonacept Regeneron injiceres i vævet lige under huden.
English: Treatment should not be initiated in patients with an active or chronic infection (see section 4.3) and physicians should exercise caution when administering Rilonacept Regeneron to patients with a history of recurring infections or with underlying conditions that may predispose them to infections.
Danish: Desuden bør læger udvise forsigtighed, når Rilonacept Regeneron administreres til patienter med gentagne infektioner i anamnesen, eller med underliggende tilstande, der kan gøre patienterne sårbare over for infektioner.
English: The following items are included in each Rilonacept Regeneron dose pack:
Danish: Hver enkelt Rilonacept Regeneron dosispakning inderholder følgende dele:
English: Throw away the vials, used syringes and needles in the punctureresistant container.
Danish: Hætteglassene, anvendte sprøjter og kanyler bortskaffes i den punkterfri beholder.
English: • Upper respiratory infection
Danish: • Infektion i de øvre luftveje
English: STEP 3: Filling a syringe with sterile water for injection (solvent) Snap off the plastic tab on the top of the vial containing sterile water for injection (solvent).
Danish: TRIN 3: Påfyldning af sprøjte med sterilt vand til injektion (solvens) 1.
English: • Stomach/Intestinal infection
Danish: • Mave-tarm-infektion
English: • Pneumonia
Danish: • Lungebetændelse
English: Carefully turn the vial upside down.
Danish: Vend forsigtigt hætteglasset på hovedet.
English: The solution is viscous, clear and colourless to pale yellow.
Danish: Opløsningen er viskos, klar og farveløs til lysegul.
English: - The active substance is rilonacept.
Danish: Rilonacept Regeneron indeholder: - Aktivt stof: rilonacept.
English: 220 mg rilonacept METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: How to store Rilonacept Regeneron
Danish: Sådan skal De tage Rilonacept Regeneron
English: NOTE: Contact your pharmacy to report any dissolved Rilonacept Regeneron that is discoloured or contains particles.
Danish: BEMÆRK: Hvis det opløste Rilonacept Regeneron er misfarvet eller indeholder partikler, skal De kontakte apoteket for at informere dem om det.
English: Adults (including the elderly)
Danish: Mængden af Rilonacept Regeneron Voksne (herunder ældre)
English: Ask your doctor any questions that you have about rotating injection sites.
Danish: Hvis De har spørgsmål om, hvordan injektionsstederne roteres, skal De spørge Deres læge.
English: Instructions for reconstitution
Danish: Rekonstitutionsanvisninger
English: Solvent vial
Danish: SOLVENSETIKET
English: Parameter
Danish: Bivirkning
English: 23.6 to 27.2 27.3 to 30.8 30.9 to 34.4 34.5 to 38.1 38.2 to 41.7 41.8 to 45.4 45.5 to 49.0 49.1 to 52.6 52.7 to 56.3 56.4 to 59.9 60.0 to 63.5 63.6 to 67.2 67.3 to 70.8 70.9 or greater
Danish: 41,8 til 45,4
English: STEP 2: Preparing the vial of Rilonacept Regeneron powder Remove the plastic cap from the Rilonacept Regeneron vial.
Danish: TRIN 2: Klargøring af hætteglasset med Rilonacept Regeneron pulver
English: Open the wrapper that contains a syringe by pulling apart the tabs.
Danish: åbnes ved at trække fligene fra hinanden.
English: The concomitant administration of Rilonacept Regeneron with any TNF inhibitor is not recommended (see section 4.4), because an increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors.
Danish: 4.4), da en forhøjet incidens af svære infektioner er blevet associeret med administration af en anden IL-1hæmmer i kombination med TNF-hæmmere.
English: B. PACKAGE LEAFLET
Danish: B INDLÆGSSEDDEL
English: 8 disposable 3 ml syringes 8 disposable 27-gauge, 1/2-inch needles
Danish: 8 27-gauge, 1/2-tommer engangskanyler
English: 8 disposable 3-ml syringes 8 disposable 27-gauge, ½-inch needles
Danish: 8 27-gauge, ½-inch engangskanyler
English: • Flushing
Danish: • Gazebind
English: Gently pull back the plunger.
Danish: Stemplet trækkes forsigtigt tilbage.
English: the Commission Decision
Danish: Inden for en måned efter besked om Kommissionens beslutning
English: 4 vials of powder containing 220 mg rilonacept 4 vials of 5 ml solvent
Danish: 4 hætteglas med 5 ml solvens 8 engangssprøjter på 3 ml
English: NAME OF THE MEDICINAL PRODUCT Rilonacept Regeneron 80 mg/ml powder for solution for injection rilonacept STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 220 mg of rilonacept.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med pulver indeholder 220 mg rilonacept.
English: Renal impairment
Danish: Misfarvet/uklar
English: - If you get any side effects, talk to your doctor or pharmacist.
Danish: - Tal med lægen eller apoteket, hvis De får nogen form for bivirkninger.
English: Pull the needle cap straight off. Do not twist the needle or the cap as you pull it off. Gently tap the syringe until air bubbles rise to the top of the syringe (see Figure 5).
Danish: Bank forsigtigt på sprøjten, indtil luftboblerne stiger op øverst i sprøjten (se Figur 5).
English: Vertigo
Danish: Vertigo almindelig
English: Point the syringe and needle straight upward.
Danish: Vend sprøjten og kanylen lige opad.
English: 5 ml
Danish: 8 engangssprøjter på 3 ml
English: How to inject Rilonacept Regeneron
Danish: Sådan skal Rilonacept Regeneron injiceres
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Tal med lægen eller apoteket, hvis De får nogen form for bivirkninger.
English: It is injected under the skin once a month.
Danish: Det injiceres under huden én gang om måneden.
English: • These recommendations update provisional measures introduced in July 2017 which were communicated directly to healthcare professionals in the EU.
Danish: • Disse anbefalinger opdaterer de foreløbige foranstaltninger fra juli 2017, der blev fremsendt direkte til sundhedspersoner i EU.
English: The review of Zinbryta was initiated on 9 June 2017 at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af Zinbryta blev indledt den 9. juni 2017 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: Your doctor may stop your treatment and refer you to a liver specialist.
Danish: Din læge kan standse behandlingen og henvise dig til en leverspecialist.
English: Zinbryta contains the active substance daclizumab and was authorised in the EU in July 2016.
Danish: Zinbryta indeholder det aktive stof daclizumab og blev godkendt i EU i juli 2016.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 08/01/2018.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som vedtog en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 08/01/2018.
English: If you do not have your liver checked as required, your prescriptions may be stopped.
Danish: Hvis du ikke får tjekket din lever efter forskrifterne, kan dine recepter blive standset.
English: More information can be found on the medicine's dedicated page on EMA's website.
Danish: Yderligere oplysninger findes på EMA's websted under Find medicine.
English: A new written communication will be sent out to healthcare professionals with the updated recommendations.
Danish: En ny skriftlig meddelelse med de opdaterede anbefalinger vil blive fremsendt til sundhedspersoner.
English: • Contact your doctor immediately if you develop any signs and symptoms of liver problems, such as unexplained nausea (feeling sick), vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes and dark urine.
Danish: • Kontakt din læge omgående, hvis du udvikler tegn og symptomer på leverproblemer, f.eks. uventet kvalme, opkastning, mavesmerter, træthed, appetitløshed, gulfarvning af hud og øjne og mørk urin.
English: • In addition, healthcare professionals are advised of the following measures to minimise risks:
Danish: • Derudover anbefales nedenstående risikominimerende foranstaltninger, idet sundhedspersoner bør:
English: On 9 November 2017, the European Medicines Agency (EMA) concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage.
Danish: Den 9. november 2017 afsluttede det Europæiske Lægemiddelagentur (EMA) sin gennemgang af lægemidlet Zinbryta (daclizumab) til behandling af multipel sklerose og bekræftede indførelsen af yderligere begrænsninger for at reducere risikoen for alvorlig leverskade.
English: • Zinbryta can cause serious and life-threatening liver problems in some patients.
Danish: • Zinbryta kan forårsage alvorlige og livstruende leverproblemer hos nogle patienter.
English: Information for healthcare professionals
Danish: Information til sundhedspersonale
English: Details of the recommendations for patients and healthcare professionals are given below.
Danish: Nedenfor opstilles anbefalinger for patienter og sundhedspersoner.
English: An acknowledgement form for patients will be made available to confirm that patients have understood the risk.
Danish: Der udleveres en erklæringsblanket, som patienterne skal underskrive til bekræftelse af, at de har forstået risikoen.
English: • You will be given a form to fill in to show that you understand the risk to the liver and the need for regular check-ups.
Danish: • Du vil få udleveret en erklæringsblanket, som du skal udfylde for at vise, at du forstår leverrisikoen og nødvendigheden af regelmæssig kontrol.