FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Alunbrig and what is it used for?
Danish: Hvad er Alunbrig, og hvad anvendes det til?
English: Patients with severely reduced kidney function should be closely monitored especially during the first week of treatment for symptoms of lung disease such as cough or difficulty breathing.
Danish: Patienter med svært nedsat nyrefunktion bør overvåges nøje, navnlig i den første uge af behandlingen for symptomer på lungesygdom, såsom hoste eller vejrtrækningsbesvær.
English: An overview of Alunbrig and why it is authorised in the EU
Danish: En oversigt over Alunbrig, og hvorfor det er godkendt i EU
English: Once appropriate measures are taken to manage the potentially serious side effect of lung disease, the safety profile of Alunbrig is considered manageable.
Danish: Når der træffes passende foranstaltninger til at håndtere den potentielt alvorlige bivirkning lungesygdom, anses sikkerhedsprofilen for Alunbrig for at være håndterbar.
English: Alunbrig can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Danish: Alunbrig udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge med erfaring i brug af kræftlægemidler.
English: Side effects reported with Alunbrig are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Alunbrig vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The patient's cancer should be tested before starting treatment to confirm it has the gene changes affecting ALK (‘ALK-positive' status).
Danish: Patientens kræft bør testes, før behandlingen påbegyndes, for at bekræfte, at genforandringerne vedrørende ALK ("ALK-positiv"-status) er til stede.
English: The most common serious side effects (which may affect more than 1 in 50 people) are pneumonitis (inflammation in the lungs), pneumonia (infection of the lungs) and dyspnoea.
Danish: De hyppigste alvorlige bivirkninger (som optræder hos mere end 1 ud af 50 patienter) er pneumonitis (betændelse i lungerne), lungebetændelse (pneumoni) og dyspnø (vejrtrækningsbesvær).
English: Alunbrig contains the active substance brigatinib.
Danish: Alunbrig indeholder det aktive stof brigatinib.
English: Reduced doses are recommended in patients with severely reduced liver or kidney function.
Danish: Nedsat dosis anbefales til patienter med svært nedsat lever- eller nyrefunktion.
English: The active substance in Alunbrig, brigatinib, works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.
Danish: Det aktive stof i Alunbrig, brigatinib, virker ved at blokere aktiviteten af ALK, hvorved kræftens vækst og udbredelse nedsættes.
English: What are the risks associated with Alunbrig?
Danish: Hvilke risici er der forbundet med Alunbrig?
English: ALK belongs to a family of enzymes called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Danish: ALK tilhører en familie af enzymer kaldet receptor-tyrosinkinaser (RTK), der medvirker ved cellevækst og udvikling af nye blodkar, der forsyner dem.
English: It will also provide an alert card for patients summarising key safety information about the risk of lung disease with the medicine and what to do in case of signs and symptoms.
Danish: Den vil desuden udlevere et patientinformationskort med de vigtigste oplysninger om risikoen for lungesygdom ved lægemidlet samt anvisninger om, hvad man skal gøre, hvis man oplever symptomer.
English: Why is Alunbrig authorised in the EU?
Danish: Hvorfor blev Alunbrig godkendt i EU?
English: For the full list of side effects and restrictions with Alunbrig, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Alunbrig fremgår af indlægssedlen.
English: The company that markets Alunbrig will submit the results of an ongoing study on the effectiveness and safety of Alunbrig in patients with ALK-positive NSCLC who have not received previous treatment targeted to ALK.
Danish: Virksomheden, der markedsfører Alunbrig, indsender resultaterne af et igangværende studie af effektiviteten af og sikkerheden ved Alunbrig hos patienter med ALK-positiv ikke-småcellet lungekræft, som ikke tidligere har modtaget behandling målrettet ALK.
English: Alunbrig is used on its own and only if the NSCLC is ‘ALK-positive', which means that the cancer cells have certain changes affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Danish: Alunbrig anvendes alene og kun ved ikke-småcellet lungekræft, der er "ALK-positiv", dvs. at kræftcellerne har visse forandringer i det gen, der producerer proteinet ALK (anaplastisk lymfom kinase).
English: Alunbrig has been shown to be effective in treating ALK-positive NSCLC in one main study involving 222 patients in whom the disease progressed despite previous treatment with crizotinib.
Danish: Alunbrig har vist sig at være effektivt til behandling af ALK-positiv ikke-småcellet lungekræft i ét hovedstudie med 222 patienter, hos hvem sygdommen var forværret trods tidligere behandling med crizotinib.
English: How is Alunbrig used?
Danish: Hvordan anvendes Alunbrig?
English: Alunbrig is a cancer medicine that is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC) who have been treated before with a cancer medicine called crizotinib.
Danish: Alunbrig er et kræftlægemiddel til behandling af voksne med lungekræft af typen ikke-småcellet lungekræft (NSCLC), som tidligere er blevet behandlet med kræftlægemidlet crizotinib.
English: positive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion.
Danish: Hos patienter med ALK-positiv ikke-småcellet lungekræft dannes en unormal form af ALK, der stimulerer kræftcellerne til at dele sig og vokse ukontrolleret.
English: What benefits of Alunbrig have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Alunbrig?
English: Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Danish: Virkningen af behandlingen (responsen) blev vurderet ved kropsskanning og standardiserede kriterier for solide tumorer.
English: How does Alunbrig work?
Danish: Hvordan virker Alunbrig?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alunbrig have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Alunbrig.
English: Alunbrig was effective in treating patients with ALK-positive NSCLC previously treated with crizotinib.
Danish: Alunbrig var effektivt til behandling af patienter med ALK-positiv ikke-småcellet lungekræft, der tidligere var blevet behandlet med crizotinib.
English: Both medicines have been authorised in the EU through national procedures for over 40 years.
Danish: Begge lægemidler har været godkendt i EU ved nationale procedurer i over 40 år.
English: 19 August 2014 EMA/515780/2014
Danish: Den 19. august 2014 EMA/515780/2014
English: Patients using these creams should be aware of the following:
Danish: Patienter, der bruger disse cremer, skal være opmærksomme på følgende:
English: The CHMP issued an opinion in December 2013.
Danish: CHMP afgav en udtalelse i december 2013.
English: 1 For more information, see here.
Danish: 1 Yderligere information findes her.
English: Linoladiol N is marketed in Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania and Slovakia, while Linoladiol HN is marketed in Estonia, Germany, Latvia and Lithuania.
Danish: Linoladiol N markedsføres i Bulgarien, Tjekkiet, Estland, Tyskland, Ungarn, Letland, Litauen og Slovakiet, mens Linoladiol HN markedsføres i Estland, Tyskland, Letland og Litauen.
English: The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP) responsible for questions concerning medicines for human use.
Danish: Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker.
English: The German medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance of these medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Danish: Den tyske lægemiddelstyrelse bad CHMP om at foretage en fyldestgørende vurdering af forholdet mellem fordele og risici for disse lægemidler og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: • Both creams should not be used for more than 4 weeks.
Danish: • Ingen af de to cremer må bruges længere end 4 uger.
English: The review of the topical estradiol-containing medicines Linoladiol N and Linoladiol HN was triggered on 24 May 2012 by Germany, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende estradiol til lokal brug blev indledt den 24. maj 2012 af Tyskland i medfør af artikel 31 i direktiv 2001/83/EF.
English: Following a request from the company, a reexamination of the opinion for Linoladiol N was carried out and concluded in April 2014.
Danish: På anmodning af virksomheden blev der foretaget en fornyet vurdering af udtalelsen for Linoladiol N, som blev afsluttet i april 2014.
English: The CHMP's recommendations were sent to the European Commission which endorsed them and issued a final, legally binding decision valid throughout the EU on 19 August 2014.
Danish: CHMP's anbefalinger blev overgivet til Europa-Kommissionen, som godkendte dem og traf en endelig, retligt bindende afgørelse med gyldighed i hele EU den 19. august 2014.
English: The Linoladiol N cream (0.01 %w/w) contains 100 microgram of estradiol per gram, while Linoladiol HN (0.005 %w/w, 0.4 %w/w) contains 50 microgram of estradiol and 4 mg of the corticosteroid prednisolone per gram.
Danish: Linoladiol N creme (0,01 vægtprocent) indeholder 100 µg estradiol per gram, mens Linoladiol HN (0,005 vægtprocent, 0,4 vægtprocent) indeholder 50 µg estradiol og 4 mg af binyrebarkhormonet prednisolon pr. gram.
English: The final CHMP opinion was forwarded to the European Commission, which issued a final decision on 19 August 2014.
Danish: CHMP's endelige udtalelse blev overgivet til Europa-Kommissionen, der traf en endelig afgørelse den 19. august 2014.
English: If you have been using Linoladiol HN for this condition, contact your doctor to discuss alternative treatments.
Danish: Hvis du har brugt Linoladiol HN mod denne sygdom, bedes du kontakte lægen for at drøfte andre behandlingsmuligheder.
English: Treatment with both creams should be limited to a maximum duration of 4 weeks.
Danish: For begge cremer bør behandlingstiden begrænses til højst 4 uger.
English: The product information of Linoladiol N and Linoladiol HN have been updated to inform patients and healthcare professionals about these potential risks.
Danish: Produktinformationen for Linoladiol N og Linoladiol HN er blevet bragt ajour, så patienter og sundhedspersoner orienteres om disse potentielle risici.
English: In addition, for Linoladiol N, the cream with the higher amount of estradiol, the CHMP has required the company to limit the amount of cream available in the packs to prevent patients from using them for longer than recommended.
Danish: For Linoladiol N, der har det største estradiolindhold af de to cremer, har CHMP desuden krævet, at virksomheden begrænser mængden af creme i pakningen, for at patienterne ikke skal kunne bruge den i længere tid end anbefalet.
English: • Both Linoladiol N and Linoladiol HN should not be used beyond four weeks due to the risks associated with possible systemic exposure to estradiol.
Danish: • Hverken Linoladiol N og Linoladiol HN må bruges længere end fire uger på grund af risiciene ved mulig systemisk eksponering for estradiol.
English: This is because the creams contain the hormone estradiol which can be absorbed into the bloodstream and may increase your risks of side effects such as blood clots and strokes if the creams are used for extended periods.
Danish: Dette skyldes, at cremerne indeholder hormonet estradiol, der kan optages i blodbanen og kan medføre øget risiko for bivirkninger såsom blodpropper og slagtilfælde, hvis cremerne bruges i længere perioder.
English: The CHMP reiterated the need to limit treatment with both creams to 4 weeks because of their relatively high estradiol content and the potential risks of side effects from estradiol being absorbed systemically (throughout the body).
Danish: For begge cremer fastholdt CHMP, at behandlingen bør begrænses til fire uger på grund af deres forholdsvis høje indhold af estradiol og den potentielle risiko for bivirkninger ved optagelse af estradiol i hele kroppen (systemisk absorption).
English: On 25 April 2014, the EMA's Committee for Medicinal Products for Human Use (CHMP) updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.
Danish: Den 25. april 2014 anbefalede EMA's udvalg for lægemidler til mennesker (CHMP) begrænsninger i brugen af de estradiolholdige højstyrkecremer Linoladiol N og Linoladiol HN.
English: Systemic absorption of estradiol may be associated with risks similar to those seen in systemic hormone replacement therapy (HRT), including blood clots, stroke and endometrial (womb) cancer.
Danish: Systemisk absorption af estradiol kan være forbundet med samme risici som systemisk hormonsubstitutionsbehandling, dvs. blodpropper, slagtilfælde og livmoderkræft (corpuscancer).
English: The European Medicines Agency has updated advice on how to use Linoladiol N and Linoladiol HN creams.
Danish: Det europæiske Lægemiddelagentur har ajourført vejledningen for, hvordan cremerne Linoladiol N og Linoladiol HN skal bruges.
English: Linoladiol HN also contains low-dose prednisolone, which acts as an anti-inflammatory agent.
Danish: Linoladiol HN indeholder desuden en lav dosis prednisolon, der modvirker hudirritation (er antiinflammatorisk).
English: • If you have any questions about your treatment, you should contact your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide om din behandling.
English: • Linoladiol HN should no longer be prescribed for lichen sclerosus.
Danish: • Linoladiol HN bør ikke længere ordineres mod lichen sclerosus.
English: The Linoladiol N cream is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of the hormone estrogen, while the Linoladiol HN cream is for postmenopausal women with mild, inflammatory skin conditions around the genital area.
Danish: Linoladiol N creme er kun til brug indvendigt i skeden hos kvinder, der efter overgangsalderen lider af udtynding af skedevæggen som følge af mangel på hormonet østrogen, mens Linoladiol HN er til kvinder efter overgangsalderen med let irritation af huden omkring de ydre kønsdele.
English: • Linoladiol HN was previously being used to treat a condition called lichen sclerosus.
Danish: • Linoladiol HN blev tidligere anvendt til behandling af hudsygdommen lichen sclerosus.
English: • Linoladiol N should be applied into the vagina while Linoladiol HN should be applied to the external genital area.
Danish: • Linoladiol N påføres i skeden, mens Linoladiol HN påføres på området omkring de ydre kønsdele.
English: • Linoladiol N is indicated for the treatment of vaginal atrophy due to estrogen deficiency in postmenopausal women.
Danish: • Linoladiol N er indiceret til behandling af vaginal atrofi som følge af østrogenmangel hos postmenopausale kvinder.
English: In addition, Linoladiol HN is no longer to be used to treat lichen sclerosus, a skin condition that commonly affects the genital area, because of a lack of evidence of benefit in this condition.
Danish: Desuden skal Linoladiol HN ikke længere anvendes til behandling af hudsygdommen lichen sclerosus, der sædvanligvis rammer området omkring kønsdelene.
English: The EMA has concluded a review of Linoladiol N and Linoladiol HN estradiol-containing creams and has updated recommendations on their use.
Danish: EMA har foretaget en gennemgang af de estradiolholdige cremer Linoladiol N og Linoladiol HN og har ajourført anbefalingerne for brugen af dem. Produktinformationen for de to cremer vil blive ajourført med følgende anbefalinger:
English: A limit to the duration of use and other measures put in place to manage potential risk of side effects
Danish: For at imødegå den potentielle risiko for bivirkninger er der indført begrænset behandlingstid foruden andre foranstaltninger
English: In December 2013, the CHMP had concluded a review of the benefits and risks of both creams and made recommendations on their use.1 Following a request by the company for a re-examination of Linoladiol N, the recommendations for this cream have been updated, taking into account new measures to manage the potential risk of side effects.
Danish: I december 2013 havde CHMP foretaget en gennemgang af fordele og risici ved de to cremer og fremsat anbefalinger fra deres anvendelse1.
English: • Linoladiol HN is indicated in the short-term treatment of acute, mild inflammatory skin diseases of the external genital area in postmenopausal women.
Danish: • Linoladiol HN er indiceret til korttidsbehandling af lette inflammatoriske hudgener omkring genitalia externa hos kvinder efter overgangsalderen.
English: Linoladiol N and Linoladiol HN are a type of local ‘hormone replacement therapy': they contain a female hormone, estradiol, used to replace the estradiol hormone the body no longer makes after menopause.
Danish: De indeholder det kvindelige kønshormon estradiol, der anvendes som erstatning for det estradiol, som kroppen ikke længere danner efter overgangsalderen.
English: • Linoladiol N is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of estrogen.
Danish: • Linoladiol N er kun til brug indvendigt i skeden til behandling af kvinder efter overgangsalderen med udtyndet skedeslimhinde som følge af østrogenmangel.
English: • Linoladiol HN should only be used for treating postmenopausal women with mild, inflammatory skin conditions affecting the external genital area.
Danish: • Linoladiol HN bør kun bruges til behandling af kvinder efter overgangsalderen med let irritation
English: A reduction of 6 points is considered a clinically meaningful improvement.
Danish: En reduktion på 6 point anses som en klinisk betydningsfuld forbedring.
English: Date of first authorisation: 22 November 2018
Danish: Dato for første markedsføringstilladelse: 22. november 2018
English: Interim analysis indicates that the effect was sustained up to one year of treatment.
Danish: En interimanalyse viser, at virkningen blev opretholdt op til et års behandling.
English: This is because it has not been studied in this age group.
Danish: Det skyldes, at medicinen ikke er blevet undersøgt i denne aldersgruppe.
English: Repeat these steps until large air bubbles are removed.
Danish: Gentag disse trin, indtil store luftbobler er fjernet.
English: Your doctor will discuss with you the risks and benefits of taking this medicine.
Danish: Din læge vil drøfte risici og fordele ved at tage denne medicin med dig.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal navnet og batchnummeret på det administrerede produkt tydeligt registreres.
English: There were no differences in international normalised ratio (INR) between treatment groups.
Danish: Der var ingen forskel i INR (International Normalized Ratio) mellem behandlingsgrupper.
English: LS mean change (SD) from baseline at week 26
Danish: LS gennemsnitsændring (SD) fra baseline i uge 26
English: There is no available information to identify potential signs and symptoms of overdose.
Danish: Der er ingen tilgængelig information, der gør det muligt at identificere potentielle tegn og symptomer på overdosering.
English: Each pack also contains the following items:
Danish: Hver pakning indeholder også følgende dele:
English: Results of the subgroup analysis were consistent with overall study results for all subjects.
Danish: Resultaterne fra undergruppeanalysen var i overensstemmelse med de generelle studieresultater for alle forsøgspersoner.
English: The anticipated time to reach steady state concentration was approximately 70 days.
Danish: Den forventede tid til at nå steady state-koncentrationen var ca. 70 dage.
English: Important: Do not shake.
Danish: Vigtigt: Må ikke rystes.
English: Adjusted p-values for multiple testing.
Danish: Justerede p-værdier for flere tests.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstiden og -forholdene indtil anvendelsen brugerens ansvar.
English: Important:
Danish: Vigtigt:
English: • It is important to use different injection sites to keep skin healthy.
Danish: • Det er vigtigt at skifte mellem forskellige injektionssteder for at holde huden sund.
English: Adjusted p-values d
Danish: Justerede p-værdier d
English: Do not inject yourself or someone else until you have been trained to inject the medicine.
Danish: Du må ikke injicere dig selv eller en anden, før du er blevet oplært i injektion af medicinen.
English: • Inject the medicine in a different place each time.
Danish: Injicer medicinen et forskelligt sted hver gang.
English: Interference with coagulation test
Danish: Interferens med koagulationstest
English: Do not touch any surface or your body, especially your face, after washing your hands before injection.
Danish: Du må ikke berøre nogen overflade eller kropsdel, særligt dit ansigt, efter at du har vasket hænder før injektionen.
English: e) Gently invert the vial 3 to 5 times to ensure the solution is mixed.
Danish: e) Vend hætteglasset forsigtigt 3 til 5 gange for at sikre, at opløsningen er blandet.
English: Endpoint statistics a
Danish: Endepunktsstatistik a
English: The injection of TAKHZYRO can be summarised in 5 steps:
Danish: Injektion af TAKHZYRO kan opsummeres i 5 trin:
English: This is so that you keep a record of the batches used.
Danish: På den måde har du en oversigt over anvendte batch.
English: All antibody titres were low.
Danish: Alle antistoftitre var lave.
English: Results of primary and secondary efficacy measures-ITT population
Danish: Resultater af primære og sekundære effektivitetsmålinger i ITT-populationen
English: Solutions that are discoloured or contain particles should not be used.
Danish: Opløsninger, der er misfarvede eller indeholder partikler, må ikke anvendes.
English: Tel: +44(0)1256 894 959
Danish: Tlf.: +44(0)1256 894 959
English: If symptoms should occur, symptomatic treatment is recommended.
Danish: Hvis der indtræder symptomer, anbefales det at give symptomatisk behandling.
English: - placebo vs TAKHZYRO at week 26 in HELP study
Danish: - placebo vs TAKHZYRO ved uge 26 i HELP-studiet.
English: Health related Quality of Life
Danish: Sundhedsrelateret livskvalitet
English: Avoid vigorous agitation.
Danish: Undgå kraftig omrysten.
English: It is important that you keep injecting TAKHZYRO as instructed by your doctor even if you feel better.
Danish: Det er vigtigt, at du bliver ved med at injicere TAKHZYRO som anvist af din læge, selv om du får det bedre.
English: % reduction relative to placebo corresponds to 100% * (1-rate ratio).
Danish: Reduktion i % i forhold til placebo svarer til 100 % * (1 - rate ratio).