natgillin/translations-raw huggingface dataset:
Hos voksne og unge er de hyppigste bivirkninger ved Tamiflu (som optræder hos mere end 1 ud af 10 patienter) hovedpine og kvalme.
The most common side effects with Tamiflu (seen in more than 1 patient in 10) in adults and adolescents are headache and nausea (feeling sick).
Hvordan anvendes Tamiflu?
How is Tamiflu used?
Hvilke fordele viser studierne, at der er ved Tamiflu?
What benefits of Tamiflu have been shown in studies?
Hvordan virker Tamiflu?
How does Tamiflu work?
Aimovig fik en markedsføringstilladelse med gyldighed i hele EU den 26. juli 2018.
Aimovig received a marketing authorisation valid throughout the EU on 26 July 2018.
Yderligere information om Aimovig findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/aimovig.
Further information on Aimovig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aimovig.
Som for alle lægemidler er data vedrørende brug af Aimovig løbende overvåget.
As for all medicines, data on the use of Aimovig are continuously monitored.
Hvad er Aimovig, og hvad anvendes det til?
What is Aimovig and what is it used for?
Den anbefalede dosis er 70 mg som en enkelt indsprøjtning hver fjerde uge.
The recommended dose is 70 mg every 4 weeks as a single injection.
En oversigt over Aimovig og hvorfor det er godkendt i EU
An overview of Aimovig and why it is authorised in the EU
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Aimovig opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency therefore decided that Aimovig's benefits are greater than its risks and it can be authorised for use in the EU.
Hvorfor blev Aimovig godkendt i EU?
Why is Aimovig authorised in the EU?
Visse patienter kan have gavn af en dosis på 140 mg hver fjerde uge indgivet som enten én enkelt indsprøjtning på 140 mg eller to indsprøjtninger på 70 mg.
Some patients may benefit from a dose of 140 mg every 4 weeks, given as either a single injection of 140 mg or two injections of 70 mg.
Andre oplysninger om Aimovig
Other information about Aimovig
For mere information om brug af Aimovig, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Aimovig, see the package leaflet or contact your doctor or pharmacist.
Det aktive stof i Aimovig, erenumab, er et monoklonalt antistof (en type protein), der er designet til at binde sig til en receptor for CGRP på kroppens celler.
The active substance in Aimovig, erenumab, is a monoclonal antibody (a type of protein) designed to attach to a receptor (target) for CGRP on body's cells.
Bivirkninger rapporteret for Aimovig vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Aimovig are carefully evaluated and any necessary action taken to protect patients.
Kun patienter med migræne mindst fire dage om måneden indgik i studierne, da patienter med færre migræneanfald normalt ikke er egnede til forebyggende behandling.
Only patients with migraines at least 4 days a month were included in the studies as patients with less frequent migraines are not usually eligible for preventative treatment.
Aimovig udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i diagnosticering og behandling af migræne.
Aimovig can only be obtained with a prescription and treatment should be started by a doctor experienced in the diagnosis and treatment of migraine.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aimovig?
What measures are being taken to ensure the safe and effective use of Aimovig?
De hyppigste bivirkninger ved Aimovig (der optræder hos op til 1 ud af 10 patienter) er reaktioner på injektionsstedet, forstoppelse, muskelspasmer og kløe.
The most common side effects with Aimovig (which may affect up to 1 in 10 people) are reactions at the site of injection, constipation, muscle spasms and itching.
Ved at binde sig til denne receptor forhindrer lægemidlet CGRP i at binde sig til receptoren og forårsage migræne.
By attaching to this receptor, the medicine stops CGRP from attaching to it and causing migraine.
De fleste bivirkninger er lette til moderate.
Most of the side effects are mild or moderate in severity.
Aimovig er et lægemiddel til forebyggelse af migræne hos voksne, der har migræne mindst fire dage om måneden.
Aimovig is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Hvilke risici er der forbundet med Aimovig?
What are the risks associated with Aimovig?
Aimovig indsprøjtes under huden med en fyldt sprøjte eller pen.
Aimovig is injected under the skin using a pre-filled syringe or pen.
I et studie med 667 patienter, der led af migræne i gennemsnitligt 18 dage om måneden, havde de patienter, der fik Aimovig, syv færre dage med migræne om måneden sammenholdt med fire færre dage hos de patienter, der fik placebo.
In a study of 667 patients who had migraines 18 days a month on average, those treated with Aimovig had 7 fewer days with migraines per month, compared with 4 fewer days for patients on placebo.
I et andet studie med 955 patienter, der led af migræne i gennemsnitligt otte dage om måneden, havde de patienter, der fik Aimovig, i gennemsnit tre-fire færre dage med migræne om måneden sammenholdt med ca. to færre dage hos de patienter, der fik placebo.
In a second study of 955 patients who had migraines 8 days a month on average, those treated with Aimovig had on average 3 to 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo.
Den fuldstændige liste over bivirkninger og begrænsninger ved Aimovig fremgår af indlægssedlen.
For the full list of side effects and restrictions of Aimovig, see the package leaflet.
Hvordan anvendes Aimovig?
How is Aimovig used?
Aimovig er effektivt til at reducere antallet af dage med migræne hos patienterne.
Aimovig is effective at reducing the number of days patients suffer migraines.
Det er påvist, at Aimovig er effektivt til at reducere antallet af dage med migræne hos patienterne.
Aimovig was shown to be effective at reducing the number of days patients have migraines.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Aimovig.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aimovig have been included in the summary of product characteristics and the package leaflet.
Det er påvist, at udvikling af migræne er forbundet med det kemiske signalstof CGRP.
A chemical messenger called CGRP has been shown to be involved in the development of migraine.
Hvilke fordele viser studierne, at der er ved Aimovig?
What benefits of Aimovig have been shown in studies?
Hvordan virker Aimovig?
How does Aimovig work?
Hver serie varer 21 dage.
Each cycle lasts 21 days.
• du skal have en vaccination, eller du ved, at du muligvis skal have en i den nærmeste fremtid
• you are due to have a vaccine or you know you may need to have one in the near future
Det kan være nye symptomer eller en ændring i dine nuværende symptomer.
These may be new symptoms or a change in your current symptoms.
Der er rapporteret reaktivering af latente infektioner.
Reactivation of latent infections has been reported.
Polivy kan forårsage IRR, inklusiv svære tilfælde.
Polivy can cause IRRs , including severe cases.
Giv understøttende behandling.
Give supportive treatment.
80% af patienterne havde refraktær sygdom.
80% of patients had refractory disease.
PET-CT PR krævede at såvel PET-CT-kriterier og CT-kriterier var opfyldt.
PET-CT PR required meeting both PET-CT criteria and CT criteria.
Prævention (kvinder og mænd)
Contraception (women and men)
• føler dig træt
• feel tired
Sikkerhed og virkning hos børn og unge i alderen under 18 år er ikke klarlagt.
The safety and efficacy in children and adolescents less than 18 years have not been established.
Polivy er ikke blevet evalueret hos patienter med HIV.
Polivy has not been evaluated in patients with HIV.
Der er ikke gennemført studier hos patienter, der nyligt har fået levende vacciner.
Studies have not been conducted in patients who recently received live vaccines.
For at behandlingen kan være effektiv, er det vigtigt ikke at springe en dosis over.
For the treatment to be fully effective, it is very important not to miss a dose.
Meget almindelig (set hos mere end 1 ud af 10 patienter)
Very common (may affect more than 1 in 10 people)
For at forbedre sporbarheden af biologiske lægemidler, bør handelsnavn og batchnummer for det administrerede produkt registreres tydeligt.
In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Polivy opbevares af sundhedspersonalet på hospitalet eller klinikken.
Polivy will be stored by the healthcare professionals at the hospital or clinic.
Følgende bivirkninger er indberettet for dette lægemiddel:
The following side effects have been reported with this medicine:
• du tror, at du har en infektion eller, at du tidligere har haft langvarige eller gentagne infektioner såsom herpes (se under “Infektioner” i afsnit 4).
• you think you have an infection or have had long-lasting or repeated infections such as herpes (see “Infections” in section 4).
5% glukose
5% Glucose
Human Immundefekt Virus (HIV)
Human Immunodeficiency Virus (HIV)
Stop ikke behandling med Polivy uden at have diskuteret det med lægen.
Do not stop treatment with Polivy unless you have discussed this with your doctor.
Stop Polivy infusion øjeblikkeligt.
Stop Polivy infusion immediately.
Natriumchlorid 9 mg/ml (0,9%)
Sodium chloride 9 mg/mL (0.9%)
Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14-a, stk. 4, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
This being a conditional marketing authorisation and pursuant to Article 14-a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Der er ingen erfaring med overdosering i kliniske humanstudier.
There is no experience with overdose in human clinical trials.
Meget almindelig pruritis
Very common pruritis
Dosis af Polivy afhænger af din kropsvægt.
The dose of this medicine depends on your body weight.
Polivy bør ikke administreres ved tilstedeværelsen af en aktiv alvorlig infektion.
Polivy should not be administered in the presence of an active severe infection.
Hvis du får en alvorlig reaktion, så vil din læge muligvis stoppe behandling med Polivy.
If you get any serious reaction, your doctor may stop treatment with Polivy.
Vær opmærksom på følgende bivirkninger
Pay attention to the following side effects
De hyppigste gastrointestinale hændelser var diarré og kvalme.
The most common gastrointestinal toxicity events were diarrhoea and nausea.
Grad 2-3
Grade 2-3
Medianalder var 69 år (30-86 år).
The median age was 69 years (range: 30-86 years).
Det rekonstituerede produkt indeholder ikke konserveringsmidler og er udelukkende beregnet til brug som enkeltdosis.
The reconstituted product contains no preservative and is intended for single-dose only.
Se afsnit 4 for mere information om bivirkninger.
See section 4 for more information about side effects.
Det kan for eksempel være:
These include:
Infusionsrelaterede reaktioner, allergiske eller anafylaktiske (mere alvorlig allergi) reaktioner, kan ske.
Infusion-related reactions, allergic or anaphylactic (more severe allergic) reactions can happen.
Din læge eller sygeplejerske vil se efter bivirkninger under din infusion og i 30-90 minutter efter.
Your doctor or nurse will check for side effects during your infusion and for 30 to 90 minutes afterwards.
Profylaktisk administration af human granulocytkolonistimulerende faktor (G-CSF) var nødvendig i den kliniske udviklingsfase og bør overvejes.
Prophylactic granulocyte colony stimulating factor (G-CSF) administration was required in the clinical development and should be considered.
Forsinkede IRR er forekommet så sent som 24 timer efter administration af Polivy.
Delayed IRRs as late as 24 hours after receiving Polivy have occurred.
Størstedelen af patienterne (98%) havde ikke yderligere specificeret DLBCL.
The majority of patients (98%) had DLBCL not otherwise specified (NOS).
Denne patient havde 3 tidligere behandlingsregimer, der inkluderede anti-CD20antistoffer.
This patient had three prior lines of therapy that included anti-CD20 antibodies.
Korrekt aseptisk teknik bør anvendes under hele håndteringen af dette lægemiddel.
Proper aseptic technique throughout the handling of this medicinal product should be followed.
Opbevaringsbetingelserne er som følger:
The storage details are as follows
Afbryd Polivy infusion og giv understøttende behandling.
Interrupt POLIVY infusion and give supportive treatment.
Bendamustin + rituximab N = 40 Median for observationstid 22 måneder
Bendamustine + rituximab N = 40 Median observation time 22 months
Afbryd Polivy-behandling indtil bedring til ≤grad 1.
Withhold Polivy dosing until improvement to ≤ Grade 1.
Lonzastrasse CH-3930 Visp Schweiz
Lonzastrasse CH-3930 Visp Switzerland
Der foreligger ingen data for gravide kvinder behandlet med Polivy.
There are no data in pregnant women using Polivy.
• hukommelsestab, problemer med at tale, besvær med at gå eller synsforstyrrelser
• memory loss, trouble speaking, difficulty walking or problems with your eyesight
Af de 173 patienter, behandlet med Polivy i studiet GO29365, var 95 (55%) ≥ 65 år.
Among 173 patients treated with Polivy in Study GO29365, 95 (55%) were ≥65 years of age.
Bestem volumen af den 20 mg/ml rekonstituerede opløsning baseret på den ønskede dosis (se nedenfor):
Determine the volume of 20 mg/mL reconstituted solution needed based on the required dose (see below):
Hvis ingen infusionsrelaterede reaktioner opstår kan efterfølgende infusioner administreres over 30 minutter.
If no infusionrelated reaction occurs, subsequent infusions may be administered over 30 minutes.
Kliniske studier med Polivy havde ikke inkluderet et stort nok antal af patienter ≥ 65 år til at bestemme om disse reagerer anderledes fra yngre patienter.
Clinical studies of Polivy did not include sufficient numbers of patients aged ≥65 to determine whether they respond differently from younger patients.
MMAE hæmmer ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6.
MMAE does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Gravide kvinder bør rådgives i forhold til risikoen for fostret.
Pregnant women should be advised regarding risk to the foetus.
Patienter med allerede eksisterende PN kan opleve forværring af tilstanden.
Patients with pre-existing PN may experience worsening of this condition.
Hvis en planlagt dosis glemmes, bør denne administreres så hurtigt som muligt, og doseringsskemaet justeres således, at der opretholdes et 21-dages interval mellem doserne.
If a planned dose of Polivy is missed, it should be administered as soon as possible and the schedule of administration should be adjusted to maintain a 21-day interval between doses.
• Den sædvanlige startdosis er 1,8 mg pr. kg. kropsvægt.
• The usual starting dose is 1.8 mg for each kilogram of your body weight.
• ubehag eller svaghed
• discomfort or weakness.
1Hvis den primære årsag er lymfom, behøver bendamustindosis muligvis ikke reduceres.
If primary cause is due to lymphoma, the dose of bendamustine may not need to be reduced.
Samlet overlevelse (OS) var et eksplorativt endepunkt, som ikke var type 1-fejl kontrolleret.
Overall survival (OS) was an exploratory endpoint which was not type 1 error controlled.
Leverenzymer og bilirubin værdier bør monitoreres.
Liver enzymes and bilirubin level should be monitored.
Du må ikke amme, mens du er i behandling med Polivy fordi en lille mængde Polivy kan passere over i modermælken.
Do not breast-feed while receiving Polivy because small amount of Polivy may pass into your breast milk.
Niveauet af MMAE-metabolitter er ikke målt i humant plasma.
The levels of MMAE metabolites have not been measured in human plasma.
Hvis du har symptomer på perifer neuropati, kan lægen vælge at sætte din dosis ned.
If you have symptoms of peripheral neuropathy, your doctor may lower your dose.
Patienter bør monitoreres tæt for nye eller forværrede neurologiske, kognitive eller adfærdsrelaterede forandringer tydende på PML.
Patients should be monitored closely for new or worsening neurological, cognitive, or behavioural changes suggestive of PML.
• du har eller har haft leverproblemer
• you have ever had liver problems
Undgå transport af den tilberedte opløsning til infusion, da rystelser kan forårsage aggregation.
Avoid transportation of the prepared solution for infusion as agitation stress can result in aggregation.
Når der tages højde for påvirkningen af baseline-kovariater, blev OS-HR justeret til 0,59.
When accounting for the influence of baseline covariates the OS HR was adjusted to 0.59.
In vitro bindes MMAE moderat (71%-77%) til humane plasmaproteiner.
In vitro, MMAE is moderately bound (71%-77%) to human plasma proteins.
Den rekonstituerede opløsning og opløsning til infusion må ikke fryses eller udsættes for direkte sollys.
The reconstituted solution and solution for infusion should not be frozen or exposed to direct sunlight.
Sværhedsgrad af IRR på dag 1 i en given serie
Severity of IRR on Day 1 of any cycle
Din læge vil tage blodprøver for at kontrollere dine blodcelletal.
Your doctor will do blood tests to check your blood cell count.
• hvis du er allergisk over for polatuzumab vedotin eller et af de øvrige indholdsstoffer i Polivy (angivet i afsnit 6).
• if you are allergic to polatuzumab vedotin or any of the other ingredients of this medicine (listed in section 6).
Når lægemidlet har bundet sig til B-cellerne, vil lægemidlet frigive MMAE ind i B-cellerne og dræbe dem.
Once attached to B cells, the medicine releases MMAE into the B cells and kills them.
Patienter, der får en overdosis, bør straks have afbrudt infusionen og monitoreres tæt.
Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Patienter med stor tumorbyrde og hurtigt prolifererende tumor kan have øget risiko for tumorlyse syndrom (TLS).
Patients with high tumour burden and rapidly proliferative tumour may be at increased risk of TLS.
De primære årsager til, at patienterne ikke var kandidater til HSCT inkluderede alder (40%), utilstrækkeligt respons på lindrende behandling (26%) og tidligere mislykket transplantation (20%).
Primary reasons patients were not candidates for HSCT included age (40%), insufficient response to salvage therapy (26%) and prior transplant failure (20%).
Hvis en IRR forekommer, afbryd infusionen og administrer passende medicinsk behandling (se pkt.
If an IRR occurs, the infusion should be interrupted and appropriate medical management should be instituted (see section 4.2).
Hvis den forudgående infusion var veltolereret, kan den efterfølgende dosis af Polivy administreres som en 30 minutters infusion, og patienter skal monitoreres under infusionen og i mindst 30 minutter efter infusionens afslutning.
If the prior infusion was well tolerated, the subsequent dose of Polivy may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion.
Procedurer for korrekt håndtering og bortskaffelse af antineoplastiske og cytotoksiske lægemidler skal anvendes.
Procedures for proper handling and disposal of antineoplastic and cytotoxic medicines should be used.
Grad 3-4 trombocytopeni
Grade 3-4 Thrombocytopenia
Grad 4 IRR
Grade 4 IRR
• gulfarvning af huden eller det hvide i øjnene
• yellowing of skin or whites of your eyes
Derfor kan en sammenligning af incidensen af antistoffer mod polatuzumab vedotin med incidensen af antistoffer mod andre lægemidler være misvisende.
For these reasons, comparison of incidence of antibodies to polatuzumab vedotin with the incidence of antibodies to other products may be misleading.
I alt havde 48% af patienterne aktiveret B-celle-DLBCL, og 40% havde germinal center B-celle-lignende DLBCL.
Overall, 48% of patients had activated B-cell (ABC) DLBCL and 40% had germinal center B-cell like (GCB) DLBCL.
Denne mekanisme er i overensstemmelse med MMAEs farmakologiske virkning som mikrotubulus-disruptivt stof.
This mechanism is consistent with the pharmacological effect of MMAE as a microtubule disrupting agent.
• Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP.
• Do not use this medicine after the expiry date which is stated on the carton and the vial after
Grad 1-3 IRR
Grade 1-3 IRR
Du må ikke bruge dette lægemiddel, hvis du er gravid, med mindre du og lægen beslutter, at dine fordele ved behandlingen opvejer risikoen for barnet.
You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs possible risk to the unborn baby.
På grund af det begrænsede antal anti-polatuzumab vedotin-antistofpositive patienter, kan der ikke konkluderes vedrørende potentiel effekt i forhold til immunogenicitet på virkning eller sikkerhed.
Due to the limited number of anti-polatuzumab vedotin antibody positive patients, no conclusions can be drawn concerning a potential effect of immunogenicity on efficacy or safety.
Plasmaeksponering af ukonjugeret MMAE er <3% af acMMAEoptaget.
Plasma exposures of unconjugated MMAE are < 3% of acMMAE exposures.
Administrér præmedicinering ved alle serier.
Administer premedication for all cycles.
Den initiale dosis af Polivy bør administreres som en 90-minutters intravenøs infusion.
The initial dose of Polivy should be administered as a 90-minute intravenous infusion.
Investigator-vurderet progressionsfri overlevelse var et eksplorativt endepunkt, som ikke var type 1fejl kontrolleret.
Investigator-assessed progression free survival (PFS) was an exploratory endpoint which was not type 1 error controlled.
Populationsestimatet for central fordeling af acMMAE er 3,15 l, ca. svarende til plasmavolumen.
The population estimate of central volume of distribution for acMMAE was 3.15 L, which approximated plasma volume.
Der bør iværksættes relevante tiltag/ profylaktisk behandling i overensstemmelse med lokale retningslinjer inden behandling med Polivy påbegyndes.
Appropriate measures/prophylaxis in accordance with local guidelines should be taken prior to treatment with Polivy.
Kontakt straks lægen eller sundhedspersonalet, hvis du oplever én eller flere af følgende alvorlige bivirkninger - du kan have behov for akut medicinsk behandling.
Tell your doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment.
Patienter bør monitoreres tæt for TLS under behandling med Polivy.
Patients should be monitored closely for TLS during treatment with Polivy.
Der blev ikke set nogen signifikant forskel i farmakokinetikken for acMMAE og ukonjugeret MMAE blandt patienter <65 år (n = 187) og patienter ≥65 år (n = 273).
No significant difference was observed in the pharmacokinetics of acMMAE and unconjugated MMAE among patients < 65 years of age (n = 187) and patients ≥ 65 years of age (n = 273).
Før du får behandlingen og under hele behandlingen er det vigtigt at informere lægen, hvis du er gravid, tror du kan være gravid eller planlægger at blive gravid.
It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Hvis du stopper behandlingen, kan det forværre tilstanden.
This is because stopping treatment may make your condition worse.
Det aktive indholdsstof i Polivy består af et monoklonalt antistof, bundet til MMAE, et stof der kan dræbe kræftceller.
The active substance in Polivy is made up of a monoclonal antibody linked to MMAE, a substance that can kill cancer cells.
Det er vigtigt fordi Polivy kan skade barnet.
This is because Polivy can affect your baby's health.