FrancophonIA/ELRC3.0 huggingface dataset:
English: Iblias is available as a powder and solvent used to make a solution for injection.
Danish: Iblias fås som et pulver og en opløsningsvæske (et solvens), som bruges til at fremstille en opløsning, der gives som indsprøjtning.
English: For practical information about using Iblias, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Iblias, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Patients may develop antibodies to hamster or mouse proteins; the medicine must not be used in patients who are hypersensitive (allergic) to octocog alfa or to hamster or mouse proteins.
Danish: Lægemidlet må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for octocog alfa eller hamster- eller museproteiner.
English: What benefits of Iblias have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Iblias?
English: For further information, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: The number of bleeds that occurred during Iblias treatment was calculated as 3.8 bleeds per year on average (mostly into joints).
Danish: Ved behandling med Iblias forekom der gennemsnitligt 3,8 blødninger om året (hovedsagelig i led).
English: Iblias is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII).
Danish: Iblias er et lægemiddel til behandling og forebyggelse af blødning ved den arvelige blødningsforstyrrelse hæmofili A, der skyldes mangel på proteinet faktor VIII, som medvirker ved blodets størkning.
English: How does Iblias work?
Danish: Hvordan virker Iblias?
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems such as bleeding into the joints, muscles and internal organs.
Danish: Som følge heraf har de nemt til at bløde og kan få problemer såsom blødning i led, muskler og indre organer.
English: In addition, the safety of the medicine was considered acceptable.
Danish: Desuden blev lægemidlets sikkerhed anset for acceptabel.
English: This overview was last updated in 12-2019.
Danish: Denne oversigt blev sidst ajourført i 12-2019.
English: Zydelig received a marketing authorisation valid throughout the EU on 18 September 2014.
Danish: Zydelig fik en markedsføringstilladelse med gyldighed i hele EU den 18. september 2014.
English: Other information about Zydelig
Danish: Andre oplysninger om Zydelig
English: Further information on Zydelig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zydelig.
Danish: Yderligere information om Zydelig findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/zydelig.
English: The Agency therefore concluded that Zydelig's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Zydelig opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: As for all medicines, data on the use of Zydelig are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Zydelig løbende overvåget.
English: If the patient has severe side effects, treatment must be stopped and can be restarted at a lower dose of 100 mg twice a day.
Danish: Hvis patienten har svære bivirkninger, skal behandlingen stoppes og kan genstartes med en lavere dosis på 100 mg to gange dagligt.
English: Patients should also be monitored for infection and have regular blood tests to measure the level of white blood cells.
Danish: Patienterne bør også overvåges for infektion og jævnligt have taget blodprøver for at måle antallet af hvide blodlegemer.
English: Why is Zydelig authorised in the EU?
Danish: Hvorfor er Zydelig godkendt i EU?
English: Zydelig is available as 100 mg and 150 mg tablets.
Danish: Zydelig fås som tabletter på 100 mg og 150 mg.
English: What is Zydelig and what is it used for?
Danish: Hvad er Zydelig, og hvad anvendes det til?
English: An overview of Zydelig and why it is authorised in the EU
Danish: En oversigt over Zydelig, og hvorfor det er godkendt i EU
English: Zydelig can only be obtained with a prescription and it should be prescribed by a doctor experienced in using cancer medicines.
Danish: Zydelig fås kun på recept og bør ordineres af en læge med erfaring i brug af kræftmedicin.
English: The recommended dose is 150 mg twice a day, and treatment should be continued for as long as the patient improves or remains stable and the side effects are tolerable.
Danish: Den anbefalede dosis er 150 mg to gange dagligt, og behandlingen bør fortsætte, så længe patientens tilstand forbedres eller forbliver stabil, og så længe bivirkningerne tåles.
English: What measures are being taken to ensure the safe and effective use of Zydelig?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zydelig?
English: Side effects reported with Zydelig are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Zydelig vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The active substance in Zydelig, idelalisib, blocks the effects of an enzyme called PI3K-delta.
Danish: Det aktive stof i Zydelig, idelalisib, blokerer virkningerne af et enzym kaldet PI3K-delta.
English: For more information about using Zydelig, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Zydelig, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: By targeting this enzyme and blocking its effects, idelalisib causes death of the cancer cells, thereby delaying or stopping the progression of the cancer.
Danish: Ved at målrette dette enzym og blokere dets virkninger dræber idelalisib kræftcellerne, og forsinker eller standser dermed forværring af kræften.
English: The European Medicines Agency noted that data from the main studies showed high response rates with Zydelig in patients with chronic lymphocytic leukaemia and follicular lymphoma.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at dataene fra de vigtigste studier viste store responsrater med Zydelig hos patienter med kronisk lymfatisk leukæmi og follikulært lymfom.
English: This enzyme plays a role in the growth, migration and survival of white blood cells but is overactive in blood cancers, where it enables the survival of the cancer cells.
Danish: Dette enzym bidrager til de hvide blodcellers vækst, migration og overlevelse, og ved blodkræft er det overaktivt og gør det muligt for kræftcellerne at overleve.
English: Zydelig contains the active substance idelalisib.
Danish: Zydelig indeholder det aktive stof idelalisib.
English: What are the risks associated with Zydelig?
Danish: Hvilke risici er der forbundet med Zydelig?
English: Zydelig was also more effective than placebo in patients who had a specific genetic mutation in their cancer cells that makes them unsuitable for certain other therapies.
Danish: Zydelig var også mere effektivt end placebo hos patienter, der havde en specifik genetisk mutation i deres kræftceller, som gør dem uegnede til visse andre behandlingsformer.
English: Zydelig was effective, with 54% of patients with follicular lymphoma having either a complete or partial response to treatment.
Danish: Zydelig var effektivt, idet 54 % af patienterne med follikulært lymfom responderede enten fuldstændigt eller delvist på behandlingen.
English: All patients treated with Zydelig should also be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia, and this should be continued for up to 6 months after stopping treatment with Zydelig.
Danish: Alle patienter, der behandles med Zydelig, bør også have forebyggende medicin mod lungeinfektionen Pneumocystis jirovecii-lungebetændelse i op til 6 måneder efter afslutningen af behandlingen med Zydelig.
English: Zydelig with ofatumumab was more effective than ofatumumab alone in the treatment of CLL.
Danish: Zydelig i kombination med ofatumumab var mere effektivt end ofatumumab alene til behandling af CLL.
English: In a study of 261 previously treated CLL patients, it took over 16 months on average before the disease got worse in patients treated with Zydelig plus ofatumumab, compared with 8 months in those treated with ofatumumab alone.
Danish: I et studie med 261 tidligere behandlede CLL-patienter varede det i gennemsnit over 16 måneder, før sygdommen blev værre hos patienter, der blev behandlet med Zydelig plus ofatumumab, sammenlignet med 8 måneder hos dem, der blev behandlet med ofatumumab alene.
English: The most common side effects with Zydelig (which may affect more than 1 in 10 people) are infections (including lung infection caused by Pneumocystis jirovecii, and cytomegalovirus infections), neutropenia (low levels of neutrophils, a type of white blood cell), lymphocytosis (increased levels of lymphocytes, another type of white blood cell), diarrhoea, blood tests showing changes in the liver, rash, fever and increased blood fat levels.
Danish: De hyppigste bivirkninger ved Zydelig (som kan forekomme hos mere end 1 ud af 10 personer) er infektioner (herunder lungeinfektion forårsaget af Pneumocystis jirovecii og cytomegalovirusinfektioner), neutropeni (lavt antal neutrofiler, en type hvide blodlegemer), lymfocytose (forhøjet indhold af lymfocytter, en anden type hvide blodlegemer), diarré, blodprøver, der viser ændringer i leveren, udslæt, feber og forhøjet fedtindhold i blodet.
English: For the full list of side effects and restrictions of Zydelig, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Zydelig fremgår af indlægssedlen.
English: In a main study of 220 patients with previously treated CLL, Zydelig was more effective at treating the cancer than placebo (a dummy treatment) when both were given in combination with rituximab: 75% of patients taking Zydelig had an improvement in their disease compared with 15% of patients receiving placebo.
Danish: I et hovedstudie med deltagelse af 220 patienter med tidligere behandlet CLL var Zydelig mere effektivt til behandling af kræft end placebo (en uvirksom behandling), når de begge blev givet i kombination med rituximab: 75 % af de patienter, der fik Zydelig, oplevede en forbedring af deres sygdom sammenlignet med 15 % af de patienter, der fik placebo.
English: In follicular lymphoma, Zydelig is used on its own in patients whose disease has not improved with two previous treatments.
Danish: Til follikulært lymfom anvendes Zydelig alene hos patienter, hvis sygdomstilstand ikke er blevet bedre med to tidligere behandlinger.
English: Another main study evaluated Zydelig in patients with different lymphomas, including 72 patients with follicular lymphoma that had failed two previous treatments.
Danish: Et andet hovedstudie så nærmere på Zydelig hos patienter med forskellige lymfomer, herunder 72 patienter med follikulært lymfom, som ikke havde haft gavn af to tidligere behandlinger.
English: Zydelig was also effective in chronic lymphocytic leukaemia patients whose cancer cells have the 17p deletion or TP53 mutation, who usually have a poor outcome.
Danish: Zydelig var også effektivt hos patienter med kronisk lymfatisk leukæmi, hos hvem kræftcellerne havde den 17p-deletion eller TP53-mutation, som normalt giver dårlige resultater.
English: In CLL, Zydelig is used in combination with another medicine (rituximab or ofatumumab) in patients who have received at least one previous treatment and in patients whose cancer cells have genetic mutations (changes) called 17p deletion or TP53 mutation and who cannot be treated with any other therapy.
Danish: Til CLL anvendes Zydelig i kombination med et andet lægemiddel (rituximab eller ofatumumab) hos patienter, der har fået mindst én tidligere behandling, og hos patienter, hvis kræftceller har genetiske mutationer (ændringer) kaldet 17p-deletion eller TP53-mutation, og som ikke kan behandles med anden terapi.
English: Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (CLL, a cancer of a type of white blood cells called B lymphocytes) and follicular lymphoma (another cancer that affects B lymphocytes).
Danish: Zydelig er et kræftlægemiddel, der anvendes til behandling af kronisk lymfatisk leukæmi (CLL, en type kræft i de hvide blodlegemer kaldet B-lymfocytter) og follikulært lymfom (en anden type kræft, der påvirker B-lymfocytterne).
English: How is Zydelig used?
Danish: Hvordan anvendes Zydelig?
English: Zydelig should not be started in patients with any generalised infection (infection that has spread with symptoms affecting the whole body, such as fever and chills).
Danish: Patienter med en generaliseret infektion (en infektion, der har spredt sig med symptomer, der berører hele kroppen, f.eks. feber og kulderystelser), bør ikke behandles med Zydelig.
English: What benefits of Zydelig have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zydelig?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zydelig have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zydelig.
English: How does Zydelig work?
Danish: Hvordan virker Zydelig?
English: Wash your hands.
Danish: Vask hænderne.
English: SN: {number} [serial number]
Danish: SN: {nummer} [serienummer]
English: 2 years.
Danish: 2 år.
English: • At the request of the European Medicines Agency.
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: It is important to have your hands and the items you use as clean as possible.
Danish: Det er vigtigt, at dine hænder og de genstande, du bruger, er så rene som muligt.
English: General information:
Danish: Generelle oplysninger:
English: This half-life may vary from patient to patient.
Danish: Denne halveringstid kan variere fra patient til patient.
English: All other patients should be observed for at least 20 minutes after administration.
Danish: Alle andre patienter skal observeres i mindst 20 minutter efter administration.
English: Arms: The back of the upper arm should be used.
Danish: Arme: Bagsiden af overarmen bør bruges.
English: The dose will depend on your condition.
Danish: Dosis afhænger af din tilstand.
English: Self-administration was feasible for most patients.
Danish: Selvadministration var mulig for de fleste patienter.
English: IgG and IgG-complexes are broken down in the reticuloendothelial system.
Danish: IgG og IgG-komplekser nedbrydes i det retikuloendoteliale system.
English: True hypersensitivity reactions are rare.
Danish: Ægte overfølsomhedsreaktioner er sjældne.
English: All patients used antiviral medicine.
Danish: Alle patienter anvendte antiviral medicin.
English: The individual treatment duration per patient was planned to be up to 24 weeks after transplantation.
Danish: Den individuelle behandlingsvarighed var planlagt til op til 24 uger efter transplantation.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/600/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/600/001
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: Then start the rotation again.
Danish: Derefter kan du begynde forfra på rotationen.
English: It's harder to give yourself an injection here.
Danish: Det er sværere at give sig selv en injektion her.
English: No other non-clinical trials have been carried out.
Danish: Der er ikke udført andre non-kliniske studier.
English: Zutectra has a half-life of about 3-4 weeks.
Danish: Zutectra har en halveringstid på ca. 3-4 uger.
English: Find a clean place where you can spread out all the items you are going to use:
Danish: Find et rent sted, hvor du kan sprede alt det ud, som du skal bruge:
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: An updated RMP should be submitted
Danish: En opdateret RMP skal fremsendes:
English: Try to take the injection at the same time of day.
Danish: Forsøg at tage injektionen på det samme tidspunkt hver dag.
English: All patients included in this study had to run through a training period of at least 29 days and home self-administration could start on day 36 at the earliest.
Danish: Alle patienter, der deltog i dette studie, skulle gennemføre en træningsperiode på mindst 29 dage, og selvadministrationen i hjemmet kunne tidligst starte på dag 36.
English: Paediatric population There is no relevant indication for use of Zutectra in children under the age of 18.
Danish: Pædiatrisk population Der er ingen relevante indikationer for brug af Zutectra til børn under 18 år.
English: In most cases you will be given the injection by your doctor or nurse.
Danish: I de fleste tilfælde vil du få injektionen af lægen eller sygeplejersken.
English: Before the injection:
Danish: Inden injektionen:
English: With the exception of 6 patients who withdrew prior to day 36, all patients achieved complete hospital and home self-administration.
Danish: Med undtagelse af 6 patienter, der udgik før dag 36, gennemførte alle patienter fuldstændigt hospitals- og selvadministrationen i hjemmet.
English: - Examine the solution carefully.
Danish: - Undersøg nøje opløsningen.
English: Zutectra might affect the results of certain blood tests (serological tests).
Danish: Zutectra kan påvirke resultatet af visse blodprøver (serologiske prøver).
English: Consequences of an overdose are not known.
Danish: Konsekvenserne af overdosering kendes ikke.
English: Rotating sites means starting at one site and using all other sites before going back to the first site you used.
Danish: Du roterer injektionssteder ved at starte ét sted og bruge alle de andre steder, inden du vender tilbage til det sted, du brugte først.
English: Your doctor will explain you how to use it.
Danish: Din læge vil forklare dig, hvordan du skal bruge den.
English: Inject beneath the skin as you have been shown by the doctor or nurse.
Danish: Foretag injektion under huden, som lægen eller sygeplejersken har vist dig.
English: ATC code: J06BB04
Danish: ATC-kode: J06BB04
English: It may be helpful to keep a record of where you had the last injection to avoid problems.
Danish: Det kan være en hjælp at notere, hvor du sidst har foretaget en injektion for at undgå problemer.
English: Possible interference with blood tests
Danish: Mulig påvirkning af blodprøver
English: No re-infection was observed.
Danish: Reinfektion blev ikke observeret.
English: In a local tolerance trial in rabbits, there was no evidence of irritation attributable to Zutectra.
Danish: I lokale toleransforsøg hos kaniner var der ingen dokumentation for irritation, som skyldes Zutectra.
English: It's important to change (rotate) the injection sites.
Danish: Det er vigtigt at skifte (rotere) injektionsstedet.
English: It should be clear and contain no particles.
Danish: Den skal være klar og må ikke indeholde partikler.
English: Summary of the safety profile
Danish: Oversigt over sikkerhedsprofilen
English: C/Frederic Mompou, 5 - 6° 3a A
Danish: C/ Frederic Mompou, 5 - 6º 3ª A
English: There is no data about efficacy in post-exposure prophylaxis.
Danish: Der findes ingen data om effektiviteten ved profylakse efter eksponering.
English: Do not take a double dose to make up for a forgotten injection.
Danish: Du må ikke tage dobbeltdosis som erstatning for den glemte injektion.
English: No patient experienced HBV re-infection.
Danish: Ingen patient oplevede HBV-reinfektion.
English: If you do choose to inject your arm yourself, try to pinch up the tissue by placing your upper arm over the back of a chair or brace it against a wall.
Danish: Hvis du vælger selv at foretage injektion i armen, så prøv at klemme vævet sammen ved at placere overarmen over ryggen på en stol eller holde den mod væggen.
English: However, if your antibody levels are sufficient and you have a fixed dose regimen, you or your caregiver may be trained to carry out the injection at home (see below).
Danish: Men hvis dit antistof-niveau er tilstrækkeligt, og du har et fast dosisprogram, kan du eller din plejer trænes til at udføre injektionen hjemme (se nedenfor).
English: A failure rate of 0 % was also found for the facultative extension phase (week 24) (95 % CI: [0, 20.6 %])
Danish: Der blev fundet en fejlprocent på 0 % for den fakultative ekstensionsfase (uge 24) (95 % CI: [0; 20,6 %]).
English: Carefully push the plunger in until the air bubbles have disappeared.
Danish: Tryk forsigtigt stemplet ind, indtil luftboblerne er væk.
English: Dispose of all used items
Danish: Bortskaf alle brugte dele
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal der anvendes almindelig shockbehandling.
English: No fertility studies have been performed (see section 5.3).
Danish: Der er ikke udført fertilitetsstudier (se pkt.
English: Do not inject into a blood vessel.
Danish: Må ikke sprøjtes ind i et blodkar.
English: Interference with serological testing
Danish: Interferens med serologiske analyser
English: If the recipient is a carrier of HBsAg, there is no benefit in administering this medicinal product.
Danish: Hvis modtageren er bærer af HBsAg, er der ingen fordel ved at administrere dette lægemiddel.
English: Rare*
Danish: Sjælden*
English: Choose the area where you will make the injection and make a note of it in the diary.
Danish: Vælg det sted, hvor du vil foretage injektionen, og noter det i din dagbog.
English: Distribution of IgG subclasses: IgG1:
Danish: Fordeling af IgG-underklasser: IgG1:
English: You can inject Zutectra yourself without the help of your doctor, if they have trained you to do this.
Danish: Du kan selv foretage injektion med Zutectra uden hjælp fra din læge, hvis du trænes i at gøre det.
English: * single case reports Adverse reactions observed with other human immunoglobulin preparations
Danish: * Enkeltstående rapporterede tilfælde Bivirkninger observeret med andre humane immunglobulinpræparater
English: For subcutaneous use only.
Danish: Kun til subkutan anvendelse.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Patients should be HBsAg negative before treatment start.
Danish: Patienterne skal være HBsAg-negative før behandlingsstart.
English: For your own safety you will be monitored for antibody levels regularly.
Danish: For din egen sikkerheds skyld kontrolleres dit antistof-niveau løbende.
English: No patient prematurely discontinued the study due to lack of feasibility of home self-treatment.
Danish: Ingen patienter afbrød studiedeltagelse før tid på grund af manglende muligheder for at foretage selvadministration i hjemmet.