FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended starting dose of Farydak is 20 mg, taken on days 1, 3, 5, 8, 10 and 12 of the cycle.
Danish: Den anbefalede startdosis af Farydak er 20 mg, som tages på dagene 1, 3, 5, 8, 10 og 12 i hver cyklus.
English: The CHMP therefore decided that Farydak's benefits are greater than its risks in this group and recommended that it be approved for use in the EU.
Danish: CHMP konkluderede derfor, at fordelene ved Farydak opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Farydak is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Farydak anvendes så sikkert som muligt.
English: Because the number of patients with multiple myeloma is low, the disease is considered ‘rare', and Farydak was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 November 2012.
Danish: Da antallet af patienter med myelomatose er lavt, anses sygdommen for ‘sjælden', og Farydak blev udpeget som ‘lægemiddel til sjældne sygdomme' den 8. november 2012.
English: This is expected to stop the cancer cells from multiplying and to activate processes that kill the cell, thereby slowing down the growth of the cancer.
Danish: Denne metode forventes at standse kræftcellernes formering og aktivere de processer, som dræber cellen, hvorved kræftvæksten sker i et langsommere tempo.
English: The full EPAR and risk management plan summary for Farydak can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Farydak findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In addition, the company that markets Farydak will provide educational materials for patients, including a patient card, to help them take the medicine correctly.
Danish: Derudover vil virksomheden, som markedsfører Farydak, sørge for oplysende materiale, herunder et patientkort, til disse patienter, som skal hjælpe dem med at indtage lægemidlet korrekt.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom delay the dose in patients who experience severe side effects.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom patienter med klinisk gavnlig effekt fortsætter behandlingen i yderligere otte cyklusser.
English: What measures are being taken to ensure the safe and effective use of Farydak?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Farydak?
English: What is Farydak and what is it used for?
Danish: Hvad er Farydak, og hvad anvendes det til?
English: Farydak contains the active substance panobinostat.
Danish: Farydak indeholder det aktive stof panobinostat.
English: This means that for patients who have previously received at least two previous treatments, including bortezomib and immunomodulatory agents, who have limited treatment options and therefore a high unmet medical need, it offers a new alternative.
Danish: Det betyder, at patienter, som tidligere har modtaget mindst to behandlinger med bortezomib og immunmodulatorer, som har begrænsede behandlingsmuligheder og derfor et stort behov for medicinsk behandling, får tilbudt et nyt alternativ.
English: Although the side effects were of concern and could not be justified in patients who could be given less toxic treatments, the CHMP considered that they were acceptable in this previously treated subgroup in view of the lack of alternatives, and could be managed.
Danish: Skønt bivirkningerne var bekymrende, og selvom de ikke kunne retfærdiggøres af en gruppe patienter, som havde mulighed for at få en mindre toksisk behandling, konkluderede CHMP, at bivirkningerne var acceptable og kunne håndteres, da der ikke var andre alternativer for denne tidligere behandlede undergruppe.
English: Farydak must not be used in women who are breast-feeding.
Danish: Farydak må ikke anvendes til ammende kvinder.
English: Why is Farydak approved?
Danish: Hvorfor blev Farydak godkendt?
English: The most significant effects that led to patients having to stop treatment (which happened in about 4 patients in 10) were diarrhoea, weakness and tiredness, and pneumonia (lung infection).
Danish: De mest bemærkelsesværdige bivirkninger, som medførte, at nogle patienter var nødt til at ophøre med behandlingen (det skete for ca. 4 patienter ud af 10), var diarré, svækkelse og træthed samt pneumoni (lungebetændelse).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Farydak can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Farydak findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The main measure of effectiveness was the average length of time before the patient's disease got worse again (progression-free survival), which was 12 months in patients given Farydak, compared with around 8 months in those given placebo.
Danish: Den vigtigste målestok for effektivitet var den periode, som i gennemsnit forløb, før patientens sygdom igen blev værre (progressionsfri overlevelse), og som viste sig at være 12 måneder for patienter, som fik Farydak, sammenlignet med ca. 8 måneder for patienter, som fik placebo.
English: In multiple myeloma, panobinostat is expected to keep genes that suppress the division and growth of the cancer cells switched ‘on'.
Danish: Ved myelomatose forventes det, at panobinostat sørger for at holde de gener 'slået til', som undertrykker kræftcellernes deling og vækst.
English: When results were analysed just for the group of patients who had previously received at least two previous treatments, including bortezomib and an immunomodulatory medicine (thalidomide, lenalidomide or pomalidomide), the average time until the myeloma got worse was 12.5 months with Farydak, versus 4.7 months with placebo.
Danish: Da resultaterne blev analyseret alene for den gruppe patienter, som havde modtaget mindst to tidligere behandlinger med bortezomib og en immunmodulator (thalidomid, lenalidomid eller pomalidomid), var den gennemsnitlige periode, før myelomatosen forværredes, 12,5 måned med Farydak mod 4,7 måned med placebo.
English: What are the risks associated with Farydak?
Danish: Hvilke risici er der forbundet med Farydak?
English: The active substance in Farydak, panobinostat, is a type of medicine called a histone deacetylase (HDAC) inhibitor.
Danish: Det aktive stof i Farydak, panobinostat, er en type lægemiddel, som kaldes histon-deacetylase (HDAC)-hæmmer.
English: Patients are given the medicine for 8 cycles, and further 8 cycles of treatment are recommended in those that benefit.
Danish: Patienter bør behandles i otte cyklusser.
English: It is not intended to provide practical advice on how to use Farydak.
Danish: Det er ikke en praktisk vejledning i, hvordan Farydak bør anvendes.
English: For more information about treatment with Farydak, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Farydak, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Farydak, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Farydak herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The most common side effects with Farydak (which may affect more than 1 in 10 people) are diarrhoea, tiredness, nausea (feeling sick) and vomiting, and effects on the blood such as thrombocytopenia (low levels of blood platelets which are important for blood clotting), anaemia and neutropenia and lymphopenia (low levels of certain white blood cells).
Danish: De hyppigste bivirkninger ved Farydak (som optræder hos mere end 1 ud af 10 patienter) er diarré, træthed, svimmelhed (kvalme) og opkastning samt påvirkning af blodet såsom trombocytopeni (lavt niveau af blodplader, som spiller en vigtig rolle for at få blodet til at størkne (koagulere)), anæmi og neutropeni og lymfopeni (lavt niveau af visse hvide blodceller).
English: Treatment with Farydak must be started by a doctor experienced in the treatment of cancer and the medicine can only be obtained with a prescription.
Danish: Behandling med Farydak skal påbegyndes af en læge med erfaring i kræftbehandling.
English: It blocks the activity of enzymes called histone deacetylases (HDACs), which are involved in switching the activity of genes on and off within cells.
Danish: Det blokerer den enzymatiske aktivitet af de såkaldte HDAC'er, som medvirker til, at genaktiviteten i cellerne 'slås til eller fra'.
English: It is given to adults whose disease has come back or got worse after at least two previous treatments, including bortezomib and an immunomodulatory medicine (a medicine that acts on the immune system).
Danish: Det gives til voksne patienter, som har haft tilbagefald eller forværring af sygdommen, og som har modtaget mindst to forudgående behandlinger med bortezomib og en immunmodulator (et lægemiddel, som påvirker immunsystemet).
English: For the full list of all side effects reported with Farydak, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Farydak fremgår af indlægssedlen.
English: Farydak is available as capsules (10, 15 and 20 mg) and it is given in 21-day treatment cycles, together with bortezomib and dexamethasone.
Danish: Farydak fås som kapsler (10, 15 og 20 mg), og patienterne behandles i en 21-dages cyklus sammen med bortezomib og dexamethason.
English: Farydak is a cancer medicine used in combination with two other medicines, bortezomib and dexamethasone, to treat multiple myeloma (a cancer of the bone marrow).
Danish: Farydak er et lægemiddel mod kræft, som i kombination med to andre lægemidler, bortezomib og dexamethason, anvendes til behandling af myelomatose (knoglemarvskræft).
English: The benefits of Farydak have been shown in one main study involving 768 patients with multiple myeloma that had come back after previous treatments.
Danish: Denne undersøgelse omfattede 768 patienter med myelomatose, som havde fået tilbagefald efter tidligere behandlinger.
English: For practical information about using Farydak, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Farydak, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The medicine was compared with placebo (a dummy treatment) as an addition to treatment with bortezomib and dexamethasone.
Danish: Farydak blev sammenlignet med placebo (virkningsløs behandling) som tillæg til behandlingen med bortezomib og dexamethason.
English: How is Farydak used?
Danish: Hvordan anvendes Farydak?
English: What benefits of Farydak have been shown in studies?
Danish: Fordelene ved Farydak er blevet påvist i en hovedundersøgelse.
English: Effects on the heart occurred in between 1 and 2 patients in 10 and included tachycardia (increased heart rate), palpitations, and irregular heart rhythms (atrial fibrillation, sinus tachycardia); more rarely patients had changes in electrical conduction in the heart (prolonged QTc interval).
Danish: Påvirkning af hjertet forekom hos 1-2 patienter ud af 10 og omfattede takykardi (øget hjertefrekvens), palpitation og uregelmæssig hjerterytme (atrieflimren, sinus takykardi).
English: How does Farydak work?
Danish: Hvordan virker Farydak?
English: The doctor may have to adjust or
Danish: For patienter, som oplever alvorlige bivirkninger, kan det være nødvendigt, at lægen justerer eller forsinker behandlingsdosis.
English: For further information, see the summary of product characteristics (part of the product information).
Danish: De nærmere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: Packaging Content Package size
Danish: Emballage Pakningsstørrelse Emballagestørrelser
English: Consideration should be given to the following:
Danish: Man bør være opmærksom på følgende:
English: ATC code: G04BE10.
Danish: ATC-kode: G04BE10.
English: Do not take Spedra:
Danish: Tag ikke Spedra:
English: Therefore, M4 accounts for approximately 4% of total pharmacologic activity.
Danish: M4 tegner sig dermed for ca. 4 % af den totale farmakologiske aktivitet.
English: Do not take Spedra if any of the above apply to you.
Danish: Tag ikke Spedra, hvis noget af ovenstående gælder for dig.
English: There was no effect on the extent of exposure (AUC).
Danish: Der er ingen virkning på eksponeringsgraden (AUC).
English: Spedra should not be taken by children and adolescents under 18 years of age.
Danish: Børn og unge Spedra bør ikke anvendes af børn og unge under 18 år.
English: • If you have had a stroke or heart attack in the last 6 months
Danish: • hvis du har haft et slagtilfælde eller hjerteanfald inden for de seneste 6 måneder
English: • an erection that will not go away (“priapism”).
Danish: • en rejsning, der ikke vil gå væk (priapisme).
English: • pink or red urine, blood in the urine
Danish: • lyserød eller rød urin, blod i urinen
English: It may be risky for you to have sexual intercourse
Danish: Det kan være risikabelt for dig at have samleje.
English: • sudden decrease or loss of vision in one or both eyes.
Danish: • pludseligt større eller mindre tab af syn på et eller begge øjne
English: • antibiotics for infections such as erythromycin
Danish: • antibiotika mod infektioner såsom erythromycin
English: The maximum recommended dosing frequency is once per day.
Danish: Den anbefalede maksimale dosishyppighed er én gang daglig.
English: Avanafil has a terminal half-life of approximately 6-17 hours.
Danish: Avanafil har en terminal halveringstid på ca. 6-17 timer.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 June 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF MARKEDSFØRINGSTILLADELSEN Dato for første markedsføringstilladelse: 21. juni 2013 Dato for sidste fornyelse:
English: Avanafil is rapidly absorbed.
Danish: Avanafil absorberes hurtigt.
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: Du kan desuden indberette bivirkninger direkte via det nationale rapporteringssystem anført i Appendiks V. Ved at indberette bivirkninger kan du medvirke til at skaffe flere oplysninger om sikkerheden af dette lægemiddel.
English: Avanafil has no effect in the absence of sexual stimulation.
Danish: Avanafil har ingen virkning ved fravær af seksuel stimulation.
English: Sexual stimulation is required for a response to treatment.
Danish: Seksuel stimulation er en forudsætning for respons på behandlingen.
English: Not all pack sizes may be marketed in your country.
Danish: Ikke alle pakningsstørrelser bliver nødvendigvis markedsført i dit land.
English: If this happens, do not drive, cycle, use tools or machines.
Danish: Hvis det sker, må du ikke føre motorkøretøj, cykle eller arbejde med værktøj eller maskiner.
English: • The active substance is avanafil.
Danish: • Det aktive stof er avanafil.
English: Avanafil is approximately 99% bound to plasma proteins.
Danish: Avanafil er ca. 99 % bundet til plasmaproteiner.
English: Populations not studied
Danish: Ikke undersøgte populationer
English: You and your partner will still need to use foreplay to get ready for sex - just as you would if you were not taking a medicine to help you.
Danish: Du og din partner har stadig brug for forspil for at blive klar til sex - ligesom hvis du ikke havde taget noget lægemiddel.
English: You may get more side effects than usual and they may be worse.
Danish: Du kan få flere og værre bivirkninger end normalt.
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Danish: Der blev ikke fundet bevis for positiv klinisk virkning af kombinationen på den undersøgte population.
English: The M16 metabolite was inactive against PDE5.
Danish: M16-metabolitten var inaktiv over for PDE5.
English: Spedra does not cure your condition.
Danish: Spedra helbreder ikke din lidelse.
English: • feeling strange
Danish: • følelse af at have det mærkeligt
English: The safety profile of Spedra is based on 2,566 subjects exposed to avanafil during the clinical development program.
Danish: Sikkerhedsprofilen af avanafil er baseret på 2.566 personer, der er blevet eksponeret for avanafil under det kliniske udviklingsprogram.
English: • If you are taking riociguat.
Danish: • hvis du indtager riociguat.
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex France
Danish: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex Frankrig
English: If you are taking riociguat or are unsure tell your doctor.
Danish: Hvis du tager riociguat eller er usikker, skal du tale med din læge.
English: Potential for pharmacodynamic interactions with avanafil Nitrates
Danish: Potentiale for farmakodynamiske interaktioner med avanafil Nitrater
English: However, data on subjects older than 70 years are limited.
Danish: For personer over 70 år foreligger dog kun begrænsede data.
English: Avanafil is rapidly absorbed after oral administration, with a median Tmax of 30 to 45 minutes.
Danish: Avanafil absorberes hurtigt efter oral administration med en median Tmax på 30-45 minutter.
English: The small changes in avanafil Cmax are considered to be of minimal clinical significance.
Danish: De små ændringer i Cmax for avanafil anses for at være af minimal klinisk betydning.
English: This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited.
Danish: Dette øger blodtilførslen til penis og medvirker til, at den holder sig hård og rejst, når du er seksuelt ophidset.
English: • If you have low blood pressure or high blood pressure not controlled by medicines
Danish: • hvis du har for lavt blodtryk eller for højt blodtryk, der ikke er reguleret ved behandling
English: • spontaneous erection without sexual stimulation
Danish: • spontan rejsning uden seksuel stimulation
English: Spedra contains the active substance avanafil.
Danish: Spedra indeholder det aktive stof avanafil.
English: Effect on bleeding
Danish: Effekt på blødning
English: Dose adjustments are not required in elder patients.
Danish: Der kræves ikke dosisjustering hos ældre patienter.
English: Patients should be informed not to take Spedra in such combinations.
Danish: Patienten skal have at vide, at han ikke skal anvende Spedra i sådanne kombinationer.
English: • phenobarbital or primidone - for epilepsy
Danish: • phenobarbital eller primidon - mod epilepsi
English: • If you have heart trouble.
Danish: • hvis du har hjerteproblemer.
English: • If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for avanafil eller et af de øvrige indholdsstoffer i Spedra (angivet i punkt 6)
English: Protein binding is independent of total active substance concentrations, age, renal and hepatic function.
Danish: Proteinbindingen er uafhængig af den totale koncentration af aktivt stof, alder og nyre- og leverfunktion.
English: Adverse reaction (MedDRA Preferred Term) System Organ Class Common
Danish: Bivirkning (MedDra-betegnelse) Systemorganklasse Almindelig
English: Spedra has minor influence on the ability to drive and use machines.
Danish: Spedra påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Dose adjustments can also be required if Spedra is used together with certain other medicines.
Danish: Dosisændring kan desuden være nødvendig, hvis Spedra bruges sammen med visse andre lægemidler.
English: • trouble sleeping (insomnia)
Danish: • søvnproblemer (søvnløshed)
English: Angina pectoris Tachycardia
Danish: Angina pectoris Takykardi
English: Older patients (65 years or over) had comparable exposure to that seen in younger patients (18-45 years).
Danish: Hos ældre patienter (65 år og derover) var eksponeringen den samme som hos yngre patienter (18-45 år).
English: Some men taking medicines like Spedra have had problems with their sight and hearing - see “Serious side effects” in section 4 for more details.
Danish: Nogle mænd, der har taget lægemidler som Spedra, har fået problemer med synet og hørelsen - se nærmere under “alvorlige bivirkninger” i afsnit 4.
English: • carbamazepine - for epilepsy, to stabilise your mood or for certain types of pain
Danish: • carbamazepin - mod epilepsi, til stabilisering af sindsstemning eller mod visse typer smerter.
English: Elderly(≥ 65 years old)
Danish: Ældre(≥ 65 år)
English: Patients were instructed to take 1 dose of study medicinal product approximately 30 minutes prior to initiation of sexual activity.
Danish: Patienterne blev instrueret i at tage en dosis af studielægemidlet ca. 30 minutter før påbegyndelse af seksuel aktivitet.
English: If you take too much Spedra, you should tell your doctor straight away.
Danish: Hvis du har fået for meget Spedra, skal du straks sige til lægen.
English: • If you suffer from priapism, that is a persistent erection lasting 4 hours or more.
Danish: • hvis du lider af priapisme, dvs. rejsning, der varer ved i mere end 4 timer.
English: Spedra is not for women.
Danish: Spedra er ikke beregnet til kvinder.
English: Patients should be advised to avoid grapefruit juice within 24 hours prior to taking avanafil.
Danish: Patienten bør rådes til at undgå grapefrugtjuice i en periode på 24 timer, inden han tager avanafil.
English: After oral administration, avanafil is excreted as metabolites predominantly in the faeces (approximately 63% of administered oral dose) and to a lesser extent in the urine (approximately 21% of the administered oral dose).
Danish: Efter oral administration udskilles avanafil som metabolitter hovedsagelig i fæces (ca. 63 % af den administrerede orale dosis) og i mindre grad i urinen (ca. 21 % af den administrerede orale dosis).
English: Remember that Spedra will only help you to get an erection if you are sexually stimulated.
Danish: • Husk, at Spedra kun hjælper dig med at få erektion, hvis du bliver seksuelt stimuleret.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development (see section 5.3).
Danish: Dyrestudier viser ingen direkte eller indirekte skadelige effekter på graviditet, embryonal/føtal udvikling, fødsel eller postnatal udvikling (se pkt.
English: In a patient who has taken avanafil within 12 hours, where nitrate administration is deemed medically necessary in a lifethreatening situation, the likelihood of a significant and potentially dangerous drop in blood pressure is increased.
Danish: Hos patienter, der har fået avanafil inden for de seneste 12 timer, og hos hvem administration af nitrat anses for akut nødvendigt i en livstruende situation, er der øget risiko for et væsentligt og potentielt farligt blodtryksfald.
English: The use of avanafil is contraindicated in:
Danish: Avanafil er kontraindiceret ved:
English: This is thought to result from the combined effects of nitrates and avanafil on the nitric oxide/cGMP pathway.
Danish: Dette antages at skyldes den kombinerede virkning af nitrater og avanafil på nitrogenoxid-/cGMPsignalvejen.