FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kepivance 6.25 mg powder for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Kepivance 6,25 mg pulver til injektionsvæske Palifermin
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 6,25 mg
English: Prior to administration, visually inspect the solution for discolouration and particulate matter before administration, see section 6.6.
Danish: Inden indgivelsen skal opløsningen kontrolleres visuelt for misfarvning og partikeldannelse, før den indgives, se pkt.
English: - if you are allergic to palifermin, Escherichia coli derived proteins or any other ingredients of
Danish: Det skal De vide, før De begynder at bruge Kepivance Brug ikke Kepivance: - Hvis De er allergisk over for palifermin, over for proteiner, som er produceret af Escherichia coli, eller et af de øvrige indholdsstoffer i Kepivance (angivet i punkt 6).
English: These patient-reported outcomes were highly correlated to the clinician grading of
Danish: Disse patient-rapporterede resultater var i høj grad korreleret til klinikerens graduering af oral mucositis efter WHO skalaen.
English: After single intravenous doses of 20 to 250 micrograms/kg (healthy volunteers) and 60 micrograms/kg (cancer patients), palifermin exhibited rapid extravascular distribution In patients with haematological malignancies mean Vss was 5 l/kg and mean clearance about 1300 ml/hour/kg with an average terminal half-life of approximately 4.5 hours.
Danish: Hos patienter med hæmatologiske maligniteter var gennemsnitlig Vss 5 l/kg, og gennemsnitlig clearance cirka 1300 ml/time/kg med en gennemsnitlig terminal halveringstid på cirka 4,5 timer.
English: Justification for not including Braille accepted
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om blindeskrift
English: NAME OF THE MEDICINAL PRODUCT Kepivance 6.25 mg powder for solution for injection
Danish: LÆGEMIDLETS NAVN Kepivance 6,25 mg pulver til injektionsvæske, opløsning.
English: Patient incidence of WHO Grade 4 oral Median (25th, 75th percentile) days of
Danish: Median (25., 75. percentil) dage med WHO Grad 3/4 oral mucositis hos berørte patienter
English: Each vial contains 6.25 mg of palifermin Reconstituted Kepivance contains 5 mg/ml of palifermin
Danish: Rekonstitueret Kepivance indeholder 5 mg/ml palifermin
English: • tingling of the mouth;
Danish: • prikkende følelse i munden,
English: It is not known whether Kepivance is excreted in human milk, therefore Kepivance should not be administered to women who are breast-feeding.
Danish: Det vides ikke, om Kepivance udskilles i human modermælk.
English: Days
Danish: Lot
English: The efficacy results are presented
Danish: Virkningsmekanisme
English: One of the side effects of these treatments is oral mucositis.
Danish: En af bivirkningerne ved disse behandlinger er mucositis (ømhed, tørhed og betændelse i munden).
English: Median (25th, 75th percentile) Cumulative Dose (morphine mg equivalents) Patient Incidence of Total Parenteral Nutrition (TPN)
Danish: Median (25., 75. percentil) dage med WHO Grad 3/4 oral mucositis** Patientforekomst af WHO Grad 3/4 oral mucositis**
English: Median (25th, 75th percentile) days of Median (25th, 75th percentile) days of
Danish: Median (25., 75. percentil) dage med WHO Grad 2/3/4 oral mucositis** Opioide analgesika for oral mucositis:
English: Skin and subcutaneous tissue disorders
Danish: Knogler, led, muskler og bindevæv
English: 6 vials containing powder for solution for injection
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 6 hætteglas indeholdende pulver til injektionsvæske, opløsning.
English: Sucrose
Danish: Skarpsyn
English: None were considered serious in nature.
Danish: Ingen blev betragtet som alvorlige.
English: 17% previously treated
Danish: 17 % tidligere behandlet
English: These symptoms are not really flu, see below.
Danish: Disse symptomer er ikke rigtig influenza, se nedenfor.
English: Date of first authorisation: 18 July 2014 Date of latest renewal: 25 March 2019
Danish: Dato for første markedsføringstilladelse: 18. juli 2014 Dato for seneste fornyelse: 25. marts 2019
English: 125 (full dose)
Danish: 125 (fuld dosis)
English: - Depression or problems affecting your mood
Danish: - Depression eller problemer, som påvirker dit humør
English: See section 4 for the symptoms of an allergic reaction.
Danish: Se punkt 4 for symptomer på en allergisk reaktion.
English: This is normal and will not affect your dose.
Danish: Det er normalt, og det påvirker ikke din dosis.
English: The majority of enzyme elevations were <3 times the upper limit of normal (ULN).
Danish: De fleste enzymforhøjelser var <3 gange den øvre normalgrænse (ULN).
English: This regular schedule helps to deliver the treatment as evenly as possible.
Danish: Denne regelmæssige plan er med til at give dig behandlingen så jævnt som muligt.
English: Results for this study are shown in Table 3.
Danish: Resultaterne for dette studie er vist i tabel 3.
English: • Each pen can be used once only.
Danish: • Hver pen må kun bruges én gang.
English: open here
Danish: åbnes her
English: The study design and patient demographics are presented in Table 2.
Danish: Studiedesignet og patientdemografien præsenteres i tabel 2.
English: You will hear the clicking sounds start.
Danish: Du vil nu høre, at kliklydene starter.
English: Treatment can then continue with the next scheduled dose as planned.
Danish: Behandlingen kan derefter fortsætte med den næste planlagte dosis efter skemaet.
English: If a dose is missed, it should be administered as soon as possible.
Danish: Hvis en dosis glemmes, skal den tages så hurtigt som muligt.
English: - Serious allergic reaction
Danish: - Alvorlig allergisk reaktion
English: Clinical experience in patients aged above 65 years is limited.
Danish: De kliniske erfaringer hos patienter over 65 år er begrænsede.
English: They may be signs of a possible liver problem.
Danish: Det kan være tegn på et muligt leverproblem.
English: Do not use the pen if:
Danish: Du må ikke bruge pennen, hvis:
English: - Contact a doctor immediately.
Danish: - Kontakt omgående en læge.
English: Speak to your doctor or pharmacist about how much to take and how long to take it.
Danish: Tal med din læge eller apotekspersonalet om, hvor meget du skal tage, og hvor længe du skal tage det.
English: Results in this subgroup were numerically consistent with those in the overall population but not statistically significant.
Danish: Resultaterne i denne undergruppe var numerisk overensstemmende med den generelle population, men var ikke statistisk signifikante.
English: Table 2: Study design
Danish: Tabel 2: Studiedesign
English: Day 0
Danish: Dag 0
English: Interferons are natural substances made in the body to help protect from infections and diseases.
Danish: Interferoner er naturlige stoffer, der dannes i kroppen, og som hjælper med at beskytte mod infektioner og sygdomme.
English: Plegridy is not to be used in children and adolescents below 18 years old.
Danish: Plegridy må ikke bruges til børn og unge under 18 år.
English: - Blood problems
Danish: - Blodproblemer
English: • Record the date and location of each injection.
Danish: • Notér dato og sted for hver injektion.
English: The average molecular mass is approximately 44 kDa of which the protein moiety constitutes approximately 23 kDa.
Danish: Den gennemsnitlige molekylmasse er ca. 44 kDa, hvoraf proteinfraktionen udgør ca. 23 kDa.
English: Therefore, the long-term safety of chronic administration of Plegridy to patients cannot be assessed on the basis of these studies.
Danish: Derfor kan den langsigtede sikkerhed af kronisk administration af Plegridy hos patienter ikke vurderes på grundlag af disse studier.
English: Results in this subgroup were consistent with those in the overall population.
Danish: Resultaterne i denne undergruppe stemmer overens med den generelle population.
English: The validity of extrapolating these non-clinical data to humans is unknown.
Danish: Gyldigheden af ekstrapolering af disse prækliniske data til mennesker er ikke kendt.
English: Treatment with Plegridy can help to prevent you from getting worse, although it will not cure MS.
Danish: Behandling med Plegridy kan være med til at forhindre, at du får det værre, men det vil ikke helbrede din MS.
English: Patients who failed previous MS treatment were not included in the study.
Danish: Patienter, som ikke havde haft gavn af tidligere MS-behandling, blev ikke inkluderet i studiet.
English: This disrupts the messages between the brain and other parts of the body, causing the symptoms of MS.
Danish: Det afbryder signalerne mellem hjernen og andre dele af kroppen, og det er det, der forårsager MS-symptomerne.
English: The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Danish: Proceduren for selvadministration af patienten bør gennemgås jævnligt, især hvis der har været reaktioner på injektionsstedet.
English: In case of over-dose, patients may be hospitalized for observation and appropriate supportive treatment should be given.
Danish: I tilfælde af overdosering kan patienterne indlægges til observation på hospitalet, og der bør gives passende understøttende behandling.
English: See section 6.3 for additional information on storage at room temperature.
Danish: 6.3 for yderligere oplysninger om opbevaring ved stuetemperatur.
English: Results over 2 years confirmed that efficacy was maintained beyond the placebo controlled first year of the study.
Danish: Resultater over 2 år bekræftede, at virkningen blev opretholdt ud over det placebokontrollerede første år af studiet.
English: • If some areas are too difficult for you to reach, ask a carer who has been trained to help you.
Danish: • Hvis nogle områder er for svære for dig at nå, kan du bede en anden, som har fået undervisning, om at hjælpe dig.
English: Mean age (years)
Danish: Gennemsnitsalder (år)
English: The primary endpoint was the annualised relapse rate (ARR) over 1 year.
Danish: Det primære endepunkt var attakkfrekvensen på årsbasis (ARR) over 1 år.
English: The potency of this medicinal product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Danish: Dette lægemiddels styrke bør ikke sammenlignes med styrken af et andet pegyleret eller non-pegyleret protein i den samme terapeutiske klasse.
English: However, do not inject more than once in a 7-day period.
Danish: Du må dog ikke injicere mere end én gang i løbet af en periode på 7 dage.
English: This can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Danish: Det kan være med til at reducere antallet af dine attakker, og det kan forsinke de invaliderende virkninger af MS.
English: - If you have severe depression or think about committing suicide.
Danish: - Hvis du lider af svær depression eller har selvmordstanker.
English: The pack contains 3 inner cartons.
Danish: Pakningen indeholder 3 indre pakninger.
English: The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Danish: Bivirkningerne er præsenteret med de foretrukne MedDRA-termer under MedDRAsystemorganklassen.
English: b. Check the expiry date.
Danish: b. Kontrollér udløbsdatoen.
English: Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.
Danish: Behandlingen bør indledes under supervision af en læge med erfaring i behandling af multipel sklerose.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1, 000 to <1/100) Rare (≥1/10, 000 to <1/1,000)
Danish: Meget almindelig (≥1/10) Almindelig (≥1/100 til <1/10) Ikke almindelig (≥1/1.000 til <1/100) Sjælden (≥1/10.000 til <1/1.000)
English: Plegridy has no or negligible influence on the ability to drive and use machines.
Danish: Plegridy påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Decreased peripheral blood counts
Danish: Nedsatte perifere blodtællinger
English: Note: You might see air bubbles in the medicine window.
Danish: Bemærk: Du kan måske se luftbobler i medicinvinduet.
English: Neutralising antibodies have the potential to reduce clinical efficacy.
Danish: Neutraliserende antistoffer kan reducere den kliniske virkning.
English: Time*
Danish: Tidspunkt*
English: The Initiation Pack contains your first two injections to gradually adjust your dose.
Danish: Startpakken indeholder de to første injektioner, for at du gradvist kan øge dosen.
English: Sometimes you will need to remind other healthcare professionals that you are being treated with Plegridy.
Danish: Sommetider vil det være nødvendigt, at du minder sundhedspersonalet om, at du bliver behandlet med Plegridy.
English: Warnings and precautions Talk to your doctor if you have ever had:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, hvis du tidligere har haft:
English: Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Danish: Patienter med myelosuppresion kan have behov for mere intensiv overvågning af komplette blodtællinger med differential- og trombocyttælling.
English: Proportion with 12 week confirmed disability progression*
Danish: Antal med 12 ugers bekræftet udvikling af handicap*
English: If you do not hear clicking sounds or you do not see green ticks in the injection status window after attempting to inject, the pen may have locked and you may not have received your injection.
Danish: Hvis du ikke hører kliklyde, eller du ikke ser grønne striber i injektionsstatusvinduet, når du har forsøgt at injicere, kan pennen være låst, og du har måske ikke fået din injektion.
English: This is normal and does not need to be expelled before your injection.
Danish: Det er normalt, og de behøver ikke at blive fjernet før injektionen.
English: Table 1: Titration schedule at initiation Dose
Danish: Tabel 1: Titreringsskema ved initiering Dosis
English: • If 7 days or more to the next planned dose: Patients should administer their missed dose immediately.
Danish: • Hvis der er 7 dage eller mere til næste planlagte dosis: Patienten skal tage den glemte dosis med det samme.
English: Amount (micrograms)
Danish: Mængde (mikrogram)
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
Danish: • Den anbefalede opbevaring er i køleskab ved 2 °C til 8 °C i den lukkede originalpakning for at beskytte mod lys.
English: - If you have used more than one injection of Plegridy in a 7-day period, contact your doctor or nurse straight away.
Danish: - Hvis du har taget mere end én injektion af Plegridy i løbet af en periode på 7 dage, skal du omgående kontakte din læge eller sygeplejerske.
English: - Contact a doctor as they may be signs of a possible kidney problem.
Danish: Kontakt en læge, da disse symptomer kan være tegn på et muligt nyreproblem.
English: The incidence of the adverse reactions below are expressed according to the following categories:
Danish: Frekvensen af nedenstående bivirkninger er udtrykt i følgende kategorier:
English: Day 28
Danish: Dag 28
English: a. Check the injection status window.
Danish: a. Kontrollér injektionsstatusvinduet.
English: Wash your hands with soap and water.
Danish: Vask hænder med vand og sæbe.
English: This is to reduce the risk of injection site reactions.
Danish: Det vil mindske risikoen for reaktioner på injektionsstedet.
English: • You do not see the green stripes in the injection status window.
Danish: • Du ikke kan se de grønne striber i injektionsstatusvinduet.
English: This tells you that the injection is happening (see Figure G).
Danish: Det fortæller dig, at injektionen er i gang (se figur G).
English: If the patient experiences any break in the skin, which may be accompanied by swelling or drainage of fluid from the injection site, the patient should be advised to speak with their doctor.
Danish: Hvis patienten oplever læsioner i huden, som kan være ledsaget af hævelse eller væske fra injektionsstedet, bør patienten rådes til at tale med lægen.
English: Only open the pack when you need a new pen.
Danish: Du må kun åbne pakningen, når du skal bruge en ny pen.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, immunostimulants, interferons, ATC code: L03AB13
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende agens, immunostimulanser, interferoner, ATC-kode: L03AB13
English: Day 28 and then every two weeks after that (125 micrograms)
Danish: Dag 28 og derefter hver 2. uge (125 mikrogram)
English: If you accidentally prick yourself or someone else with the needle in Plegridy, the area affected should be washed immediately with soap and water and a doctor or nurse should be contacted as soon as possible.
Danish: Hvis du kommer til at stikke dig selv eller en anden med kanylen i Plegridy, skal du straks vaske det berørte område med vand og sæbe, og du skal kontakte en læge eller sygeplejerske så hurtigt som muligt.
English: Interferons are a family of naturally occurring proteins that are induced by cells in response to biological and chemical stimuli, and mediate numerous cellular responses that have been classified as antiviral, antiproliferative, and immunomodulatory in nature.
Danish: Interferoner er en familie af naturligt forekommende proteiner, der induceres af celler som reaktion på biologiske og kemiske stimuli og medierer flere cellerespons, som er blevet klassificeret som antivirale, antiproliferative og immunmodulerende.
English: Data from studies with other interferon beta compounds did not show teratogenic potential.
Danish: Data fra studier med andre interferon beta-forbindelser viste ikke teratogent potentiale.
English: On average, flu-like symptoms begin approximately 10 hours after injection and last between 12 and 24 hours.
Danish: I gennemsnit begynder de influenzalignende symptomer ca. 10 timer efter injektionen og varer i 12 til 24 timer.
English: CI: Confidence interval * Sustained disability progression was defined as at least a 1 point increase from baseline EDSS ≥ 1 or 1.5 point increase for patients with baseline EDSS of 0, sustained for 12 / 24 weeks.
Danish: CI: Konfidensinterval * Vedvarende udvikling af handicap blev defineret som mindst 1 points stigning fra baseline-EDSS ≥1 eller 1,5 points stigning for patienter med baseline-EDSS på 0 opretholdt i 12/24 uger.
English: Patients with relapsing-remitting MS have periods when the disease is not active (remission) in between flare-ups of symptoms (relapses).
Danish: Mennesker med attakvis MS har perioder, hvor sygdommen ikke er aktiv imellem opblussen af symptomer (attakker).
English: The safety and effectiveness of Plegridy in this age group are not known.
Danish: Sikkerheden og virkningen af Plegridy i denne aldersgruppe er ikke kendt.
English: - Your doctor may still prescribe Plegridy for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your mood in the past.
Danish: Din læge vil måske alligevel ordinere Plegridy til dig, men det er vigtigt, at du fortæller det til din læge, hvis du har haft en depression, eller hvis du har haft lignende problemer, der påvirker dit humør.
English: Each inner carton contains 2 pens in a protective plastic tray.
Danish: Hver indre pakning indeholder 2 penne i en beskyttende plasticbakke.
English: Reversibility of the effects on menstrual cycle length was demonstrated.
Danish: Virkningerne på menstruationscyklussens længde blev påvist reversible.
English: Subgroups of patients with higher disease activity were defined by relapse and MRI criteria as reported below, with the following efficacy results:
Danish: Undergrupper af patienter med højere sygdomsaktivitet blev definerede ved attak- og MR-kriterier som beskrevet herunder med følgende effektresultater:
English: Do not touch, clean, or manipulate the needle cover.
Danish: Du må ikke røre ved, rengøre eller håndtere kanylehætten.
English: See below for simple ways to manage these flu-like symptoms if you get them.
Danish: Se nedenfor, hvordan du håndterer de influenzalignende symptomer, hvis du får dem.
English: • Wash your hands with soap and water.
Danish: • Vask hænder med vand og sæbe.
English: Take paracetamol or ibuprofen half an hour before your Plegridy injection and continue to take paracetamol or ibuprofen for the duration of your flu-like symptoms.
Danish: Tag paracetamol eller ibuprofen en halv time inden din Plegridy-injektion og fortsæt med at tage paracetamol eller ibuprofen, så længe du har influenzalignende symptomer.
English: The experience in the randomised, uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of the ADVANCE study.
Danish: Erfaringen i den randomiserede, ukontrollerede fase (år 2) af ADVANCE-studiet og i forlængelsesstudiet ATTAIN (patienter fik behandling i op til 4 år) var i overensstemmelse med den etårige placebokontrollerede fase af ADVANCE-studiet.
English: You can inject Plegridy yourself without the help of your doctor, if you have been trained how to do this.
Danish: Du kan selv injicere Plegridy uden hjælp fra din læge, hvis lægen har vist dig, hvordan man gør.
English: Nephrotic syndrome, glomerulosclerosis
Danish: Nefrotisk syndrom, glomerulosklerose
English: • If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose.
Danish: • Hvis der er under 7 dage til næste planlagte dosis: Patienten skal påbegynde et nyt 2-ugers doseringsskema startende fra det tidspunkt, hvor patienten tager den glemte dosis.
English: Injection site erythema was the most commonly reported injection site reaction.
Danish: Erytem på injektionsstedet var den hyppigst rapporterede reaktion på injektionsstedet.
English: Collect all the supplies you will need to give yourself or to receive an injection.
Danish: Saml alle de ting sammen, du skal bruge til at give dig selv eller få en injektion.
English: Serious side effects - Liver problems
Danish: Alvorlige bivirkninger - Leverproblemer
English: To minimise the risk of injection site reactions patients should be instructed in the use of an aseptic injection technique.
Danish: For at minimere risikoen for reaktioner på injektionsstedet skal patienterne instrueres i at anvende aseptisk teknik.
English: This medicinal product contains less than 1 mmol (23 mg) sodium, that is to say it is essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium, dvs. det er i det væsentlige natriumfrit.
English: Your doctor will tell you how long you need to keep using Plegridy.
Danish: Din læge vil fortælle dig, hvor længe du behøver at bruge Plegridy.
English: Make sure you can see the green stripes in the injection status window (see Figure F).
Danish: Kontrollér, at du kan se de grønne striber i injektionsstatusvinduet (se figur F).
English: (frequency cannot be estimated from the available data) - Pulmonary arterial hypertension: A disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Danish: (hyppighed kan ikke bestemmes ud fra de foreliggende data) - Pulmonal arteriel hypertension: en sygdom med alvorlig forsnævring af blodkarrene i lungerne, hvilket medfører højt blodtryk i de blodkar, der fører blodet fra hjertet til lungerne.
English: • After 2 hours, check the injection site for redness, swelling, or tenderness.
Danish: • Efter 2 timer skal du kontrollere injektionsstedet for rødme, hævelse eller ømhed.
English: This could lock the pen
Danish: Det kan låse pennen
English: Additional supplies which are not included in the pack (See Figure B):
Danish: Andre ting, som ikke følger med i pakken (se figur B):
English: They gradually get less as you keep using your injections.
Danish: De forsvinder gradvist i takt med, at du får dine injektioner.