FrancophonIA/ELRC3.0 huggingface dataset:
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh er ansvarligt for at sikre ensartede sikkerhedsstandarder i hele EU for lægemidler, der godkendes via nationale procedurer.
English: • As before, valproate treatment should never be started unless alternative treatments are not suitable, including in young girls below the age of puberty.
Danish: • Ligesom tidligere må behandling med valproat aldrig påbegyndes, medmindre andre behandlinger ikke er egnede, hvilket ligeledes gælder for unge piger, der endnu ikke er nået pubertetsalderen.
English: The CMDh agreed with EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which carried out a review and recommended the new measures, that despite previous recommendations aimed at better informing patients of the risks with these medicines, women were still not always receiving the right information in a timely manner.
Danish: CMDh var enigt med EMA's Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC) - som foretog en gennemgang og anbefalede de nye forholdsregler - i, at kvinderne ikke altid fik de rette oplysninger i tide trods tidligere anbefalinger, som havde til formål at oplyse patienterne bedre om risiciene ved disse lægemidler.
English: Further, the medicines must not be used in any woman or girl able to have children unless the conditions of a new pregnancy prevention programme are met.
Danish: Lægemidlerne må desuden ikke anvendes til kvinder eller piger, der er i stand til at få børn, medmindre betingelserne i et nyt program for graviditetsforebyggelse opfyldes.
English: • There will be changes to the product information (package leaflet for patients and SmPC for healthcare professionals) to reflect these new conditions and also to the packaging of the medicine, including a visual warning in the form of boxed text which may be accompanied by other elements such as a symbol.
Danish: • Der vil blive foretaget ændringer af produktinformationen (indlægssedlen for patienter og produktresuméet for sundhedspersonale) svarende til disse nye vilkår, og ligeledes af lægemidlets pakning, herunder en visuel advarsel i form af en indrammet tekst, eventuelt ledsaget af andre elementer, såsom et symbol.
English: Because the CMDh position was agreed by majority vote it will now be sent to the European Commission, which will take a final legally binding decision valid across the EU.
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev den overgivet til EuropaKommissionen, som vedtog en retligt bindende afgørelse med gyldighed i hele EU.
English: It also includes a retrospective observational study to look at any association between exposure to valproate in men and the risk of malformations and developmental disorders including autism in offspring, and an observational study to evaluate and identify the best practice for stopping and switching of valproate treatment.
Danish: Det omfatter desuden en retrospektiv observationsundersøgelse af eventuel sammenhæng mellem eksponering af mænd for valproat og risikoen for, at deres afkom får misdannelser og udviklingsforstyrrelser, herunder autisme, samt en observationsundersøgelse til vurdering og fastlæggelse af den bedste praksis for ophør med og skift fra valproat.
English: In addition, there will be a patient alert card attached to the packaging so that pharmacists can go through it with the patient when the medicine is dispensed.
Danish: Derudover vil der være et patientadvarselskort, som er vedhæftet pakningen, og som apotekspersonalet kan gennemgå sammen med patienten, når lægemidlet udleveres.
English: It is known that if taken in pregnancy they can cause malformations in the baby and developmental disorders after birth.
Danish: Ved indtagelse under graviditet vides disse lægemidler at kunne forårsage misdannelser hos fosteret og udviklingsforstyrrelser efter fødslen.
English: • Valproate medicines are now therefore contraindicated, i.e. must not be used, in girls and women able to have children unless the terms of a special pregnancy prevention programme are followed.
Danish: • Lægemidler indeholdende valproat er derfor nu kontraindiceret (dvs. må ikke anvendes) hos piger og kvinder, der kan få børn, medmindre betingelserne i et særligt program til forebyggelse af graviditet bliver fulgt.
English: This will include surveys of healthcare professionals and patients to assess the reach and effectiveness of the new measures, and use of data from existing registries to further characterise the malformations known as foetal anticonvulsant syndrome in children whose mothers took valproate in pregnancy and how this compares to other anti-epileptic medicines.
Danish: Hertil hører spørgeundersøgelser blandt sundhedspersonale og patienter til vurdering af de nye foranstaltningers rækkevidde og effektivitet, anvendelse af data fra eksisterende registre til yderligere karakterisering af misdannelser, der betegnes føtalt antikonvulsivum-syndrom, hos børn af mødre, der har fået valproat under graviditeten, og sammenligning med andre antiepileptiske lægemidler.
English: Valproate medicines are used to treat epilepsy and bipolar disorder.
Danish: Lægemidler indeholdende valproat anvendes til behandling af epilepsi og bipolar sygdom.
English: • Medicines containing valproate have been available in EU countries for many years to treat epilepsy, bipolar disorder and in some countries migraine.
Danish: • Lægemidler indeholdende valproat har i mange år kunnet fås i EU-lande til behandling af epilepsi, bipolar (maniodepressiv) sygdom og i nogle lande migræne.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Danish: CMDh er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater samt Island, Liechtenstein og Norge.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Danish: CMDh er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater, Island, Liechtenstein og Norge.
English: A visual warning of the pregnancy risks (in the form of boxed text with other possible elements such as a warning symbol) must also be placed on the packaging of the medicines and warnings be included on patient cards attached to the box and supplied with the medicine each time it is dispensed.
Danish: Lægemiddelpakningen skal endvidere være påført en visuel advarsel om risiciene ved graviditet (i form af en indrammet tekst med eventuelle andre elementer, såsom et advarselssymbol), og patientkort forsynet med advarsler skal være vedhæftet kartonen, så de følger med lægemidlet, hver gang det udleveres.
English: Companies marketing these medicines are also required to carry out additional studies on the nature and extent of the risks and to monitor valproate use and the long-term effects from affected pregnancies.
Danish: De virksomheder, der markedsfører disse lægemidler, skal desuden foretage supplerende undersøgelser af risicienes art og omfang og skal overvåge anvendelsen af valproat og de langsigtede virkninger forbundet med de berørte graviditeter.
English: The CMDh1 has endorsed new measures to avoid exposure of babies to valproate medicines in the womb, because exposed babies are at high risk of malformations and developmental problems.
Danish: Den 21. marts 2018 godkendte CMDh1 nye forholdsregler der skal forebygge eksponering af fosteret for lægemidler indeholdende valproat, da eksponering af fosteret medfører høj risiko for misdannelser og udviklingsproblemer.
English: Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine.
Danish: Valproatholdige lægemidler er godkendt nationalt i EU til behandling af epilepsi og bipolar (maniodepressiv) sygdom og i nogle lande til forebyggelse af migræne.
English: The companies that market valproate must carry out further studies to characterise the nature and extent of the risks posed by valproate and monitor ongoing valproate use and the long-term effects from affected pregnancies.
Danish: De virksomheder, der markedsfører valproat, skal foretage yderligere undersøgelser til karakterisering af arten og omfanget af de risici, der er forbundet med valproat, og løbende overvåge anvendelsen af valproat og de langsigtede virkninger som følge af berørte graviditeter.
English: • In pregnancy, valproate is contraindicated and an alternative treatment should be decided on, with appropriate specialist consultation, for women planning pregnancy; however, there may be a small number of women with epilepsy for whom there is no suitable alternative treatment to valproate and who should be appropriately supported and counselled.
Danish: • Ved graviditet er valproat kontraindiceret, og for kvinder, der planlægger graviditet, bør der på baggrund af relevant specialistrådgivning træffes afgørelse om anden behandling.
English: − introduction of a new risk acknowledgement form that patients and prescribers will go through at each such annual review to confirm that appropriate advice has been given and understood.
Danish: en vurdering af hver patients mulighed for at blive gravid graviditetstest før påbegyndelse af behandlingen og efter behov under behandlingen rådgivning om risiciene ved behandling med valproat og nødvendigheden af effektiv prævention under hele behandlingen gennemgang af den igangværende behandling af en specialist mindst en gang om året indførelse af en ny formular til risikoanerkendelse, som patienter og ordinerende læger gennemgår ved hver sådan årlig undersøgelse, hvor de bekræfter, at der er givet tilbørlig rådgivning, og at denne er forstået.
English: Watch for at least 10 seconds.
Danish: Kig i mindst 10 sekunder.
English: These measures will help to protect the environment.
Danish: Disse forholdsregler er med til at beskytte miljøet.
English: This is ok.
Danish: Det er ok.
English: There is no evidence that such an interaction would be harmful.
Danish: Der er intet, som tyder på, at sådan interaktion vil være skadelig.
English: You can use:
Danish: De kan bruge:
English: Date of first authorisation: 22 August 2002 Date of latest renewal: 16 July 2007
Danish: Dato for første markedsføringstilladelse: 22. august 2002 Dato for seneste fornyelse: 16. juli 2007
English: It is important to tell your doctor if you:
Danish: Det er vigtigt at fortælle Deres læge, hvis De:
English: The relevance of these findings for humans is not known.
Danish: Relevansen af disse observationer for mennesker er ikke kendt.
English: If there are particles in it, you must not use it.
Danish: Hvis der er partikler i, må De ikke bruge den.
English: Pull straight as shown in pictures 1 and 2.
Danish: Træk lige som vist på billederne 1 og 2.
English: 27 hours
Danish: 27 timer
English: Consider wearing loose clothing and take care when changing clothes.
Danish: Overvej at bruge løstsiddende tøj og vær forsigtig, når De skifter tøj.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Danish: Som ved alle terapeutiske proteiner er der mulighed for immunogenicitet.
English: 45 minutes
Danish: 45 minutter
English: - Radiation treatment.
Danish: - Strålebehandling.
English: Splenomegaly, generally asymptomatic, is uncommon.
Danish: Splenomegali, generelt asymptomatisk, er ikke almindelig.
English: • some changes may occur in your blood, but these will be detected by routine blood tests.
Danish: • der kan forekomme forandringer i blodet, men de vil blive opdaget ved de rutinemæssige blodprøver.
English: Let your skin dry.
Danish: Lad huden tørre.
English: 100% (full)
Danish: 100% (fuld)
English: You should talk to your doctor about your risks of developing cancers of the blood.
Danish: Tal med Deres læge om risikoen for at udvikle kræft i blodet.
English: Equipment that you need
Danish: Udstyr De skal bruge
English: Neulasta has not been tested in pregnant women.
Danish: Neulasta er ikke blevet testet på gravide kvinder.
English: MedDRA system organ class
Danish: MedDRA systemorganklasse
English: • You may hear a series of clicks.
Danish: • En række kliklyde kan eventuelt høres.
English: Urinalysis monitoring is recommended.
Danish: Monitorering med urinalyser anbefales.
English: Electrical equipment
Danish: Elektrisk udstyr
English: This may affect your medicine.
Danish: Det kan påvirke medicinen.
English: Wash your hands thoroughly.
Danish: Vask Deres hænder grundigt.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: Latex may be transferred to your skin.
Danish: Latex kan overføres til Deres hud.
English: Apply a plaster if needed.
Danish: Sæt om nødvendigt et plaster på.
English: Tell your doctor if you experience those symptoms.
Danish: Fortæl det til lægen, hvis De oplever disse symptomer.
English: • Any part appears cracked or broken.
Danish: • Der er dele, som ser ud til at være revnede eller ødelagte.
English: There is a small cannula which sits just under your skin.
Danish: Der er en lille kanyle, der sidder umiddelbart under huden.
English: If it is exposed to direct sunlight for more than 1 hour, it may affect your medicine.
Danish: Hvis den udsættes for direkte sollys i mere end 1 time, kan det påvirke medicinen.
English: This means that the delivery is complete.
Danish: Det betyder, at tilførslen er færdig.
English: C RELEASE your thumb.
Danish: C GIV SLIP med tommelfingeren.
English: Step 1: Prepare
Danish: Trin 1: Forberedelse
English: • are pregnant;
Danish: • er gravid,
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med fruktoseintolerans bør ikke tage denne medicin.
English: Figure 1.
Danish: Figur 1.
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving Neulasta in nine randomised clinical trials.
Danish: Frekvensen blev estimeret ud fra en statistisk beregning baseret på 1.576 patienter, der fik Neulasta i ni randomiserede kliniske studier.
English: Step 2: Get ready A Wash your hands thoroughly.
Danish: Trin 2: Klargøring A Vask Deres hænder grundigt.
English: • think you may be pregnant; or
Danish: • tror De er gravid, eller
English: Do not warm Neulasta in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Opvarm ikke Neulasta på nogen anden måde (De bør for eksempel ikke opvarme den i mikrobølgeovn eller i varmt vand).
English: Push the plunger down with a slow constant pressure.
Danish: Tryk stemplet ned med et langsomt, konstant tryk.
English: Avoid vigorous shaking.
Danish: Undgå voldsom omrystning.
English: Wash your hands thoroughly with soap and water.
Danish: Vask Deres hænder grundigt med vand og sæbe.
English: Neulasta is for use in adults aged 18 and over.
Danish: Neulasta er beregnet til voksne fra 18 år og opefter.
English: The number of cases is small, but because of the seriousness of the ADR, the PRAC recommends that the Product Information should be updated accordingly.
Danish: Der er et lille antal tilfælde, men da bivirkningen er alvorlig, anbefaler PRAC, at produktinformationen opdateres.
English: • if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine.
Danish: • hvis De er allergisk over for pegfilgrastim, filgrastim eller et af de øvrige indholdsstoffer i dette lægemiddel.
English: • Check your status light again.
Danish: • Kontrollér statuslampen igen.
English: Check the appearance of Neulasta.
Danish: Kontroller udseendet af Neulasta.
English: The concentration is 10 mg/mL based on protein only**.
Danish: Koncentrationen er 10 mg/ml udelukkende baseret på protein**.
English: Do not reapply it.
Danish: Sæt den ikke på igen.
English: If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Danish: Hvis der opstår en alvorlig allergisk reaktion, skal passende behandling institueres med nøje patientopfølgning i flere dage.
English: • Avoid activities and places that may interfere with monitoring during the dosing of Neulasta.
Danish: • Undgå aktiviteter og steder, der gør det svært at udføre kontrollen under doseringen af Neulasta.
English: The patient alert card shall contain the following key messages:
Danish: Patientkortet skal indeholde følgende vigtige elementer:
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Danish: B PRES stemplet ned med et langsomt og konstant tryk, indtil De mærker eller hører et “klik”.
English: No adverse events directly attributable to this degree of leukocytosis have been reported.
Danish: Der er ikke blevet rapporteret nogen uønskede hændelser, der direkte kan tilskrives denne grad af leukocytosis.
English: • You should see a black line next to the 0% (empty) indicator to confirm you have received a full dose.
Danish: • Der skal være en sort streg ved siden af 0% (tom) indikatoren for at vise, at De har fået hele dosen.
English: • nausea and headaches.
Danish: • kvalme og hovedpine.
English: Your doctor or nurse will show you how to inject yourself.
Danish: Deres læge eller sygeplejerske vil vise Dem, hvordan De tager en indsprøjtning.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Do not try to inject yourself if you have not been trained.
Danish: Prøv ikke selv at indsprøjte, hvis De ikke er blevet undervist heri.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden De begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Ask your caregiver to be nearby for the first use.
Danish: Bed en plejeperson om at være i nærheden den første gang.
English: Median time to recovery from severe neutropenia was estimated as 22 days in both treatment groups.
Danish: Mediantiden til helbredelse fra alvorlig neutropeni blev vurderet til 22 dage i begge behandlingsgrupper.
English: White blood cells are important as they help your body fight infection.
Danish: Hvide blodlegemer er vigtige, idet de hjælper Deres krop med at bekæmpe infektion.
English: • Serious allergic reactions can happen with Neulasta.
Danish: • Der kan opstå alvorlige allergiske reaktioner efter anvendelse af Neulasta.
English: This is known as a subcutaneous injection.
Danish: Dette betegnes som en subkutan indsprøjtning.
English: If needed, you may cover the injection site with a plaster.
Danish: De kan om nødvendigt dække injektionsstedet med et plaster.
English: Before you inject Neulasta you must do the following:
Danish: Før De indsprøjter Neulasta, skal De gøre følgende:
English: Not working correctly
Danish: Virker ikke korrekt
English: Grab here
Danish: Tag fat her
English: Do not shake Neulasta vigorously as this may affect its activity.
Danish: Ryst ikke Neulasta kraftigt, da dette kan have negativ indflydelse på dets virkning.
English: This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler, især ikke med natriumchloridopløsninger.
English: Neulasta contains sorbitol.
Danish: Neulasta indeholder sorbitol.
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Danish: Pegfilgrastim er et protein, der produceres ved hjælp af bioteknologi i bakterier, der kaldes for E. coli.
English: Your doctor will tell you what you can take to ease the bone pain.
Danish: Deres læge vil fortælle Dem, hvad De kan tage for at lindre knoglesmerterne.
English: Note: It is normal to see a few drops of fluid at the application site, but not normal to see a noticeably wet (saturated) adhesive.
Danish: Bemærk: Det er normalt at se et par dråber væske på påsætningsstedet, men ikke normalt, hvis man kan se et tydeligt vådt (gennemblødt) klæbemiddel.
English: This should be considered when interpreting bone-imaging results.
Danish: Dette bør tages i betragtning ved analyse af knogleskanningsresultater.
English: If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Danish: Hvis antallet af hvide blodlegemer falder til et lavt niveau, er der risiko for, at der ikke er nok celler tilbage i kroppen til at bekæmpe bakterier, og De kan have en øget risiko for infektion.
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Danish: Det tilhører en gruppe proteiner, der hedder cytokiner, og ligner meget et naturligt protein (granulocytkoloni-stimulerende faktor), som kroppen selv producerer.
English: Wear the on-body injector under your clothing.
Danish: Bær on-body-injektoren under Deres tøj.
English: ** The concentration is 20 mg/mL if the PEG moiety is included.
Danish: ** Koncentrationen er 20 mg/ml, hvis PEG-delen er inkluderet.
English: Do not use this medicine if you notice it is cloudy or there are particles in it.
Danish: Brug ikke lægemidlet, hvis De bemærker, at det er grumset eller at der er partikler i det.
English: Long term outcome was not studied (see section 4.4).
Danish: Det langsigtede resultat blev ikke undersøgt (se pkt.
English: Name and address of the manufacturers of the biological active substance
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: • The medicine is cloudy or there are particles in it.
Danish: • Medicinen er grumset, eller der er partikler i den.
English: 2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults.
Danish: 2 Denne bivirkning er påvist i forbindelse med overvågning efter markedsføring, men ikke observeret i de randomiserede, kontrollerede kliniske studier hos voksne.
English: Do not use Neulasta
Danish: Brug ikke Neulasta
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende midler, kolonistimulerende faktor; ATC-kode: L03AA13
English: The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Danish: Dette produkts styrke bør ikke sammenlignes med et andet pegyleret eller ikke-pegyleret proteins styrke af samme terapeutiske klasse.
English: The patient should also be given the Patient Alert Card.
Danish: Patienten skal desuden have udleveret patientkortet.
English: • the abdomen, except for the area around the navel.
Danish: • maveregionen, undtagen området omkring navlen.
English: These elevations are transient and return to baseline.
Danish: De forhøjede værdier er forbigående og aftager til baselineniveauerne.
English: There are no or limited amount of data from the use of pegfilgrastim in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af pegfilgrastim til gravide kvinder.
English: These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Danish: Disse celler er meget modtagelige for effekterne af kemoterapi, hvilket kan medføre, at antallet af disse celler i Deres krop minsker.
English: • Only expose the on-body injector to temperatures between 5°C - 40°C.
Danish: • On-body-injektoren må kun udsættes for temperaturer fra 5 °C - 40 °C.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Danish: Giv ikke injektionen på steder, hvor huden er øm, ødelagt, rød eller hård.
English: 1 See section “Description of selected adverse reactions” below.
Danish: 1 Se afsnittet ”Beskrivelse af udvalgte bivirkninger” nedenfor.
English: This means the dose is complete.
Danish: Det betyder, at doseringen er færdig.
English: Papaellinas Ltd Τηλ.
Danish: C.A. Papaellinas Ltd Τηλ.
English: Do not touch the cleaned area of the skin.
Danish: Rør ikke ved det afrensede område af huden