FrancophonIA/ELRC3.0 huggingface dataset:
English: • breathing problems.
Danish: • åndedrætsproblemer.
English: If this happens, you may not receive your dose of Neulasta.
Danish: Hvis det sker, får De muligvis ikke den dosis Neulasta, De skal have.
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicine.
Danish: En sådan forhøjelse i leukocytter er forbigående, ses typisk 24 til 48 timer efter administration og er i overensstemmelse med de farmakodynamiske effekter af dette lægemiddel.
English: If someone else is injecting you, they can also use the back of your arms.
Danish: Hvis en anden person giver Dem indsprøjtningen, kan bagsiden af Deres arme desuden benyttes.
English: Stop using Neulasta and seek medical attention immediately if you notice any of the symptoms described in section 4.
Danish: Hold op med at bruge Neulasta, og søg øjeblikkeligt lægehjælp, hvis De bemærker et eller flere af de symptomer, der er beskrevet i afsnit 4.
English: Only use each syringe for one injection.
Danish: Anvend kun hver injektionssprøjte til én indsprøjtning.
English: This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Danish: Dette lægemiddel bør ikke anvendes til at øge dosis af cytotoksisk kemoterapi udover de fastsatte dosisregimer.
English: • Even with a leak, the status light may remain green and the fill indicator may be at 0% (empty).
Danish: • Selvom der er en utæthed, kan statuslampen stadig lyse grønt, og indikatoren kan være på 0% (tom).
English: • Outer area of upper arm (only if someone else is giving you the injection).
Danish: • forsiden af overarmen (kun, hvis en anden person giver Dem injektionen)
English: Your doctor may want to monitor you more closely.
Danish: Deres læge vil muligvis overvåge Dem nøjere.
English: Remember
Danish: Husk
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Neulasta.
Danish: Tilfældig udsættelse for frostgrader i en enkelt periode på mindre end 24 timer har ikke nogen skadelig indvirkning på stabiliteten af Neulasta.
English: • Keep the on-body injector at least 10 cm (4 inches) away from electrical equipment such as mobile phones, cordless telephones, microwaves and other common appliances.
Danish: • Hold on-body-injektoren på afstand af elektrisk udstyr (mindst 10 cm), såsom mobiltelefoner, trådløse telefoner, mikrobølgeovne og andre almindelige apparater.
English: Allergies
Danish: Allergier
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om håndtering af lægemidlet før administration, se pkt.
English: The most suitable places to inject yourself are:
Danish: De bedste steder at give indsprøjtningen er:
English: • when to expect dose delivery to begin
Danish: • information om, hvornår tilførslen af dosen kan forventes at begynde
English: Uncommon cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Danish: Der er indberettet ikke almindelige tilfælde af Sweets syndrom, omend underliggende maligne hæmatologiske sygdomme i nogle tilfælde kan spille en rolle.
English: • Remove any extra adhesive using soap and water.
Danish: • Fjern eventuelt resterende klæbemiddel med sæbe og vand.
English: In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Danish: I dyremodeller er samtidig administration af Neulasta og 5-fluoruracil (5-FU) eller andre antimetabolitter blevet vist at øge myelosuppression.
English: • after the injection is complete you are concerned that you may not have received the full dose.
Danish: • De efter at have givet en injektion er bekymret for, at De ikke har fået hele dosen.
English: This may result in a missed or incomplete dose of Neulasta.
Danish: Det kan medføre manglende eller ufuldstændig dosis af Neulasta.
English: If the patient has developed SJS with the use of pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.
Danish: Hvis patienten udvikler SJS under brug af pegfilgrastim, må behandlingen med pegfilgrastim ikke genoptages hos denne patient på noget tidspunkt.
English: Guide to parts
Danish: Vejledning til delene
English: It must be a clear and colourless liquid.
Danish: Det skal være en klar og farveløs væske.
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to 7 days, and a 30-40% incidence of febrile neutropenia.
Danish: Ved fravær af vækstfaktorstøtte har det været rapporteret, at regimet resulterede i gennemsnitlig varighed af grad 4 neutropeni på 5-7 dage, og en incidens for febril neutropeni på 30-40%.
English: Your doctor may monitor your condition more closely.
Danish: Deres læge vil muligvis overvåge Deres tilstand nøjere.
English: Neulasta therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Danish: Neulasta-terapi skal påbegyndes og overvåges af læger, der har erfaring med onkologi og/eller hæmatologi.
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Danish: Der skal udvises særlig omhu for at skelne diagnosen blast-transformation af kronisk myeloid leukæmi fra AML.
English: Please tell your doctor immediately if you have any of the following or combination of the following side effects:
Danish: Fortæl det straks til Deres læge, hvis De får en eller flere af følgende bivirkninger:
English: It may harm them, even if their symptoms of illness are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som De har.
English: For example AVOID, travelling, driving, or operating heavy machines during 26-29 hours following application of the on-body injector (this includes the 45-minute dose delivery period plus an hour post-delivery).
Danish: UNDGÅ for eksempel at rejse, køre bil og betjene kraftige maskiner i 26-29 timer efter påsætning af on-body-injektoren (dette inkluderer de 45 minutter, hvor medicinen tilføres, plus 1 time efter tilførslen).
English: This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 6 mg dosis, det vil sige, at det er stort set natriumfrit.
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Danish: Begrænsede data indikerer, at farmakokinetikken for pegfilgrastim hos ældre forsøgspersoner (> 65 år) er tilsvarende den hos voksne.
English: Check the instructions at the end of this leaflet and contact your healthcare provider if:
Danish: Læs instruktionerne sidst i denne indlægsseddel og kontakt Deres læge, hvis:
English: The on-body injector will use sounds and lights to let you know its status.
Danish: On-body-injektoren bruger lyde og lys til at vise sin status.
English: • It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
Danish: • Det er vigtigt, at De ikke forsøger at give Dem selv injektionen, medmindre De har fået instruktioner af Deres læge eller sundhedspersonalet.
English: Step 4: Finish
Danish: Trin 4: Afslut
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pegfilgrastim, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for pegfilgrastim er CHMP nået frem til følgende videnskabelige konklusioner:
English: Always take Neulasta exactly as your doctor has told you.
Danish: Brug altid Neulasta nøjagtigt efter lægens anvisning.
English: However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
Danish: Den langsigtede virkning af pegfilgrastim er dog ikke blevet fastslået ved AML, og midlet skal derfor anvendes med forsigtighed i denne patientpopulation.
English: Step 2: Monitor Dose Delivery
Danish: Trin 2: Kontrol af doseringen
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • The expiry date printed on the label has passed the last day of the month shown.
Danish: • Udløbsdatoen, der er trykt på etiketten, er overskredet (den sidste dag i den viste måned er passeret).
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor bør miltstørrelsen overvåges nøje (f.eks. ved klinisk undersøgelse med ultralyd).
English: The experience in children is limited.
Danish: Der er kun begrænset erfaring med anvendelse til børn.
English: Neulasta is injected subcutaneously via:
Danish: Neulasta injiceres subkutant via:
English: Attention!
Danish: Bemærk!
English: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
Danish: Stevens-Johnsons syndrom (SJS), som kan være livstruende eller letalt, er blevet rapporteret med hyppigheden sjælden i forbindelse med behandling med pegfilgrastim.
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Danish: Muligheden for interaktion med lithium, som også øger frisætningen af neutrofile granulocytter, er ikke blevet specifikt undersøgt.
English: Some cases of splenic rupture were fatal.
Danish: Nogle tilfælde af miltruptur var dødelige.
English: Avoid getting lotions, creams, oils or cleaning agents near the on-body injector, as these products may loosen the adhesive.
Danish: Undgå lotions, cremer, olier og rensemidler tæt på on-body-injektoren, da disse produkter kan få klæbemidlet til at løsne sig.
English: Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Danish: Knoglesmerte var generelt af let til moderat sværhedsgrad, forbigående og kunne kontrolleres med standardanalgetika hos de fleste patienter.
English: - Oxygen rich environments, such as hyperbaric chambers (a transparent chamber with an increase in atmospheric pressure).
Danish: - Iltrige omgivelser, for eksempel et trykkammer (et gennemsigtigt rum med forhøjet lufttryk).
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Danish: Find et behageligt, godt oplyst sted og læg alt, hvad De skal bruge i Deres nærhed.
English: Dispose of it in a sharps disposal container as instructed by your healthcare provider or in accordance with local requirements.
Danish: Kassér den i en kanylebøtte i overensstemmelse med sundhedspersonalets anvisninger eller i overensstemmelse med de lokale retningslinjer.
English: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Danish: For at forbedre sporbarheden af præparater indeholdende granulocytkoloni-stimulerende faktor (G-CSF) skal handelsnavnet på det administrerede præparat registreres tydeligt i patientjournalen.
English: 9/L or greater have been observed in less than 1% of patients receiving pegfilgrastim.
Danish: 9/l eller højere er set hos mindre end 1% af patienter, behandlet med pegfilgrastim.
English: Approximately 27 hours after the on-body injector is applied to the patient's skin, Neulasta will be delivered over approximately 45 minutes.
Danish: Cirka 27 timer efter, at on-body-injektoren er sat på patientens hud, vil Neulasta blive tilført i løbet af cirka 45 minutter.
English: Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Danish: Deres læge har ordineret Neulasta til Dem for at støtte Deres knoglemarv (hvor blodceller dannes) til at producere flere hvide blodlegemer, der hjælper Deres krop med at bekæmpe infektion.
English: Do not remove the on-body injector at this time.
Danish: Fjern ikke on-body-injektoren på dette tidspunkt.
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Danish: Der er rapporteret pulmonale bivirkninger, især interstitial pneumoni, efter administration af G-CSF.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: In the event of a partial or missed dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered.
Danish: I tilfælde af delvis eller manglende tilførsel af dosen, kan patienten have større risiko for bivirkninger som neutropeni, febril neutropeni og/eller infektion, end hvis dosen var blevet tilført korrekt.
English: Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Danish: På samme måde som med filgrastim, viser neutrofile granulocytter, der er dannet som reaktion på pegfilgrastim, normal eller forstærket funktion påvist via test af den kemotaksiske og fagocyterende funktion.
English: Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.
Danish: Neulasta kan anvendes, hvis det ved et uheld har været nedfrosset en enkelt gang i mindre end 24 timer.
English: Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Danish: Der er indberettet aortisis efter administration af G-CSF hos raske forsøgspersoner og kræftpatienter.
English: What should I do before I give myself a subcutaneous injection of Neulasta?
Danish: Hvad skal jeg gøre, før jeg selv foretager subkutan indsprøjtning med Neulasta?
English: The safety and efficacy of Neulasta in children has not yet been established.
Danish: Neulastas sikkerhed og virkning hos børn er endnu ikke klarlagt.
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common [≥ 1/100 to < 1/10]).
Danish: De hyppigst rapporterede bivirkninger var knoglesmerter (meget almindelig [≥ 1/10]) og muskuloskeletale smerter (almindelig [≥ 1/100 til < 1/10]).
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står efter EXP på kartonen og på injektionssprøjtens etiket.
English: See leaflet for further information.
Danish: Se indlægssedlen for yderligere oplysninger.
English: Before use
Danish: Inden brug
English: You may notice a small air bubble in the pre-filled syringe.
Danish: Man kan se en lille luftboble i den fyldte sprøjte.
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Danish: Human granulocytkolonistimulerende faktor (G-CSF) er et glykoprotein, der regulerer produktionen og afgivelsen af neutrofile granulocytter fra knoglemarven.
English: Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy.
Danish: I overensstemmelse med den kliniske effekt og risikoen for leukocytose skal WBC måles med regelmæssige intervaller under behandlingen.
English: • The on-body injector contains batteries, electronics, and a needle.
Danish: • On-body-injektoren indeholder batterier, elektronik og en kanyle.
English: Important: Do not grasp the on-body injector itself to try to pull it off of your body.
Danish: Vigtigt: Tag ikke fat i selve injektoren i et forsøg på at fjerne den fra kroppen.
English: If you are injecting yourself and have forgotten your dose of Neulasta, you should contact your doctor to discuss when you should inject the next dose.
Danish: Hvis De selv foretager injektionerne og har glemt en dosis Neulasta, kontakt da Deres læge for at aftale, hvornår De skal tage den næste dosis.
English: • Neulasta is given as an injection into the tissue just under the skin (subcutaneous injection).
Danish: • Neulasta gives som en injektion i vævet lige under huden (subkutan injektion).
English: If you develop or are likely to develop cancers of the blood, you should not use Neulasta, unless instructed by your doctor.
Danish: Hvis De udvikler kræft i blodet, eller det er sandsynligt, at De vil gøre det, bør De ikke bruge Neulasta, medmindre Deres læge sagt, at De skal gøre det.
English: Turn the plunger to move the label into a position where you can remove the syringe label.
Danish: Drej på stemplet for at få etiketten i en position, hvor den kan tages af.
English: Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of pegfilgrastim is not expected to be affected by renal or hepatic impairment.
Danish: På grund af den neutrofil-medierede clearancemekanisme forventes farmakokinetikken for pegfilgrastim ikke at blive påvirket af renal eller hepatisk svækkelse.
English: In rat studies, it was shown that pegfilgrastim may cross the placenta.
Danish: I rottestudier er det blevet vist, at pegfilgrastim kan passere placenta.
English: Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical trials.
Danish: Mulige interaktioner med andre hæmatopoietiske vækstfaktorer og cytokiner er ikke blevet specifikt undersøgt i kliniske studier.
English: B Examine the injection site.
Danish: B Undersøg injektionsstedet.
English: The on-body injector should be applied to intact, non-irritated skin on the back of the arm or abdomen.
Danish: On-bodyinjektoren skal sættes på intakt, ikke-irriteret hud på bagsiden af armen eller abdomen.
English: Your white blood cell count may become high for a short period of time.
Danish: Antallet af hvide blodlegemer kan blive kortvarigt forøget.
English: You should check with your doctor or pharmacist if you are unsure.
Danish: De bør konsultere Deres læge eller apotek, hvis De er usikker.
English: The manually administered injections should be given into the thigh, abdomen or upper arm.
Danish: De manuelt administrerede injektioner skal gives i lår, abdomen eller overarm.
English: Your doctor will check your blood and urine regularly as Neulasta can harm the tiny filters inside your kidneys (glomerulonephritis).
Danish: Deres læge vil regelmæssigt kontrollere Deres blod og urin, da Neulasta kan beskadige de bittesmå filtre i nyrerne (glomerulonefritis).
English: B After about 27 hours, your on-body injector will produce a series of beeps to let you know your dose delivery is about to begin.
Danish: B Efter cirka 27 timer vil on-body-injektoren aktivere en række biptoner for at fortælle, at tilførslen af Deres dosis er ved at starte.
English: Neulasta left at room temperature for more than 72 hours should be discarded.
Danish: Neulasta, der opbevares ved stuetemperatur i mere end 72 timer, skal kasseres.
English: Avoid injecting into areas with scars or stretch marks.
Danish: Undgå at injicere på steder, hvor der er ar eller strækmærker.
English: The elimination of pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with increasing dose.
Danish: Eliminationen af pegfilgrastim er ikke-lineær med hensyn til dosis; serumclearance af pegfilgrastim falder med stigende dosis.
English: Important
Danish: Vigtigt
English: On the basis of the scientific conclusions for pegfilgrastim the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pegfilgrastim is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for pegfilgrastim er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder pegfilgrastim, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Rates of generation of antibodies against pegfilgrastim is generally low.
Danish: Raterne for dannelse af antistoffer mod pegfilgrastim er generelt lave.
English: Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Danish: Voldsom omrystning kan medføre, at pegfilgrastim aggregerer og dermed bliver biologisk inaktivt.
English: If you have a cough, fever and difficulty breathing please tell your doctor.
Danish: Hvis De får hoste, feber og åndedrætsbesvær, skal De kontakte lægen.
English: Stop using Neulasta if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Hold op med at bruge Neulasta, hvis De udvikler disse symptomer, og søg øjeblikkeligt lægehjælp eller kontakt Deres læge.
English: If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Danish: Hvis De oplever tab af virkningen af pegfilgrastim, eller hvis virkningen ikke opretholdes, vil Deres læge undersøge grunden til det, for eksempel om De har udviklet antistoffer, der kan neutralisere pegfilgrastims aktivitet.
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Danish: Patienter, der udvikler symptomer på kapillærlækage-syndrom, bør monitoreres nøje og have symptomatisk standardbehandling, inklusive eventuel intensiv behandling efter behov (se pkt.
English: Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Danish: Der er indgivet enkelt doser på 300 mikrog/kg subkutant til et begrænset antal raske frivillige og patienter med ikke-småcellet lungecancer uden alvorlige bivirkninger.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Neulasta.
Danish: Medmindre Deres læge har sagt andet, skal De holde op med at amme, hvis De bruger Neulasta.
English: A Your dose delivery will take around 45 minutes to complete.
Danish: A Tilførslen af Deres dosis tager cirka 45 minutter.
English: Guide to parts for on-body injector for Neulasta Green flashing status light
Danish: Guide til delene på on-body-injektoren til Neulasta Blinkende grøn statuslampe
English: Neulasta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours.
Danish: Neulasta kan udsættes for stuetemperatur (ikke over 30 °C) i maksimalt en enkelt periode på op til 72 timer.
English: • Dose delivery will start and take about 45 minutes to complete.
Danish: • Tilførslen af dosen starter og varer cirka 45 minutter.
English: Profile of median pegfilgrastim serum concentration and Absolute Neutrophil Count (ANC) in chemotherapy treated patients after a single 6 mg injection
Danish: Profil over median pegfilgrastim serumkoncentration og absolut neutrofiltal (ANC) i kemoterapi-behandlede patienter efter en enkelt 6 mg injektion