FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, Cmax and bioavailability tend to decrease with increasing dose concentration while the half-life is increased.
Danish: Derfor har Cmax og biotilgængeligheden en tendens til at falde med øgning af koncentrationen af dosis, mens halveringstiden øges.
English: Administration of other concentrations is not recommended because the gel depot formation is influenced by the concentration.
Danish: Administration af andre koncentrationer anbefales ikke, da dannelsen af gel-depotet er påvirket af koncentrationen.
English: Do not give this medicine to children or adolescents.
Danish: Børn og teenagere Giv ikke denne medicin til børn eller teenagere
English: In vitro studies have shown that degarelix is not a substrate for the human CYP450 system.
Danish: In vitro-studier har vist, at degarelix ikke er et substrat for det humane CYP450system.
English: • Information on gel depot formation and possible injections site reactions
Danish: • Information om dannelsen af et gel-depot og mulige reaktioner ved injektionsstedet
English: If you have diabetes, you may have to measure blood glucose more frequently.
Danish: Hvis du har sukkersyge, kan det være nødvendigt at måle blodglukose oftere.
English: The injected liquid forms a gel from which degarelix is released over a period of one month.
Danish: Den indsprøjtede væske danner en gel, hvorfra degarelix frigives over en tidsperiode på en måned.
English: In total 620 patients were randomised to one of the three treatment groups, of which 504 (81%) patients completed the study.
Danish: I alt blev 620 patienter randomiseret i en af de tre behandlingsgrupper, hvoraf 504 (81%) af patienterne fuldførte studiet.
English: A ring of small air bubbles on the surface of the liquid is acceptable.
Danish: En ring af små luftbobler på væskeoverfladen er acceptabel.
English: This difference was statistically significant (p<0.001) for the pre-specified analysis at day 14 and day 28.
Danish: Denne forskel var statistisk signifikant (p<0,001) for den forudbestemte analyse på dag 14 og dag 28.
English: Instructions for proper use NOTE:
Danish: Brugsanvisning for korrekt brug:
English: The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
Danish: Effekt og sikkerhed af degarelix blev evalueret i et åbent, multi-center, randomiseret, aktiv komparator kontrolleret, parallel-gruppestudie.
English: Worsening or onset of diabetes may occur.
Danish: Udvikling eller forværring af diabetes kan forekomme.
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Danish: • Produktresumé (SPC), indlægsseddel og mærkning
English: Side effects at the injection site are most common with the starting dose and less common with the maintenance dose.
Danish: De bivirkninger, der er set ved injektionsstedet forekommer oftest ved den første dosis og er mindre almindelige ved vedligeholdelsesdosis.
English: Pregnancy and breast-feeding There is no relevant indication for use of FIRMAGON in women.
Danish: Graviditet og amning Der er ingen relevant indikation for brug af FIRMAGON til kvinder.
English: In case the patient's clinical response appears to be sub-optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed.
Danish: I tilfælde af at patientens kliniske respons er sub-optimalt, skal det bekræftes, at testosteronniveauet i serum stadig er tilstrækkeligt sænket.
English: If not used immediately, the use of this medicine are the responsibility of the user.
Danish: Hvis det ikke anvendes umiddelbart, er brugen af dette lægemiddel på brugerens ansvar.
English: Monitoring of liver function in patients with known or suspected hepatic disorder is advised during treatment.
Danish: Monitorering af leverfunktionen hos patienter med kendt eller mistænkt leversygdom anbefales under behandlingen.
English: It is unknown to what extent this decrease in haematological values was caused by the underlying prostate cancer and to what extent it was a consequence of androgen deprivation therapy.
Danish: Det er ukendt i hvilken grad denne nedsættelse af hæmoglobinværdier skyldtes den underliggende prostatakræft, og i hvilken grad det var en konsekvens af androgen deprivationsbehandling.
English: These side effects may be due to the treatment or effects resulting from the underlying disease.
Danish: Disse bivirkninger kan skyldes behandlingen eller opstå på grund af din sygdom.
English: If you forget to use FIRMAGON
Danish: Hvis du har glemt at bruge FIRMAGON
English: Taking into account the PRAC Assessment Report on the PSUR(s) for degarelix, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR(erne) for degarelix er CHMP nået frem til følgende videnskabelige konklusioner:
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal blive enig med de relevante nationale myndigheder om indholdet af et undervisningsprogram og skal implementere sådan et program nationalt for at sikre, at alle læger før receptudskrivelse får en informationspakke til sundhedspersonale indeholdende følgende:
English: FIRMAGON must NOT be given into a blood vessel (intravenously).
Danish: FIRMAGON må IKKE gives ind i en blodåre (intravenøst).
English: It can be anticipated that long periods of testosterone suppression in men will have effects on bone density.
Danish: Det kan forventes, at lange perioder med testosteronundertrykkelse hos mænd vil have en virkning på knogledensiteten.
English: Fertility FIRMAGON may inhibit male fertility as long as the testosterone is suppressed.
Danish: Fertilitet FIRMAGON kan hæmme den mandlige fertilitet, så længe testosteron er undertrykt.
English: The pharmacokinetic behavior of the medicinal product is influenced by its concentration in the solution for injection.
Danish: Den farmakokinetiske opførsel af lægemidlet er påvirket af dets koncentration i injektionsvæsken.
English: Seek medical advice straight away if you develop a severe rash, itching or shortness of breath or difficulty breathing.
Danish: Søg lægehjælp straks, hvis du udvikler alvorligt udslæt, kløe eller åndenød eller åndedrætsbesvær.
English: Testosterone Reversibility
Danish: Testosteron reversibilitet
English: The solvent is a clear, colourless solution.
Danish: Solvensen er en klar, farveløs opløsning.
English: • 13% had previous curative intent surgery or radiation and a rising PSA
Danish: • 13% tidligere undergået kirurgi med kurativ intension eller strålebehandling og havde en stigende
English: DK-2300 Copenhagen S Denmark
Danish: DK-2300 København S Danmark
English: In a study involving patients with rising PSA after localised therapy (mainly radical prostatectomy and radiation) were administered FIRMAGON for seven months followed by a seven months monitoring period.
Danish: I et studie med patienter med stigende PSA efter lokal behandling (hovedsageligt radikal prostatektomi og strålebehandling) blev FIRMAGON givet i 7 måneder efterfulgt af en 7 måneders monitoreringsperiode.
English: The clinical benefit for degarelix compared to leuprorelin plus anti-androgen in the initial phase of treatment has not been demonstrated.
Danish: Den kliniske fordel for degarelix sammenlignet med leuprorelin plus anti-androgen i den initiale fase af behandlingen er ikke påvist.
English: It caused a dosage dependent prolongation of the time to mating and to pregnancy, a reduced number of corpora lutea, and an increase in the number of pre- and post-implantation losses, abortions, early embryo/foetal deaths, premature deliveries and in the duration of parturition.
Danish: Det medførte en dosisafhængig forlængelse af tidsperioden til parring og til graviditet, nedsat antal af corpora lutea, og et øget antal af præ- og post-implantationstab, aborter, tidlig embryo/føtale dødsfald, for tidlig fødsel og en øget fødselsvarighed.
English: FIRMAGON is available in 2 pack-sizes.
Danish: FIRMAGON findes i 2 pakningsstørrelser.
English: FIRMAGON contains degarelix.
Danish: FIRMAGON indeholder degarelix.
English: The prostate volume reduction was similar to that attained with goserelin plus anti-androgen protection.
Danish: Reduktionen i prostatavolumen svarede til det, der blev opnået med goserelin plus anti-androgen beskyttelse.
English: Do not use this medicine after the expiry date which is stated on the vials, syringes and outer packaging.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på hætteglassene, sprøjter og yderpakningen.
English: There is no clinical experience with the effects of an acute overdose with degarelix.
Danish: Der er ingen klinisk erfaring med virkningerne af et akut tilfælde af overdosering med degarelix.
English: Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
Danish: Afbryd proceduren og kassér sprøjten og kanylen (klargør en ny dosis til patienten).
English: Both in vitro and in vivo studies showed no signs of QT prolongation.
Danish: Hverken in vitro- eller in vivo-studier viste tegn på QT-forlængelse.
English: Therefore, clinically significant pharmacokinetic drug-drug interactions in metabolism related to these isoenzymes are unlikely.
Danish: Derfor er det usandsynligt, at der er klinisk relevante farmakokinetiske lægemiddelinteraktioner relateret til metabolisme med disse isoenzymer.
English: Hypertension, vasovagal reaction (incl.
Danish: Hypertension, vasovagal reaktion (inkl.
English: The long half-life after subcutaneous administration is a consequence of a very slow release of degarelix from the depot formed at the injection site(s).
Danish: Den lange halveringstid efter subkutan administration er en konsekvens af en meget langsom frigivelse af degarelix fra depotet dannet ved injektionsstedet/-stederne.
English: The lowest effective maintenance dose of 80 mg degarelix was chosen.
Danish: Den mindste effektive vedligeholdelsesdosis på 80 mg degarelix blev valgt.
English: In conclusion, rhabdomyolysis should be added to the list of ADRs of the Product Information with a frequency rare.
Danish: Konklusionen er, at rabdomyolyse skal føjes til listen af bivirkninger i produktinformationen med frekvensen sjældent.
English: The effect of degarelix on insulin and glucose levels has not been studied.
Danish: Virkningen af degarelix på insulin- og glukoseniveau er ikke undersøgt.
English: Choose a different injection site and inject 3 ml.
Danish: Vælg et andet injektionssted og injicér 3,0 ml.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet i rækkefølge med aftagende alvorlighedsgrad.
English: Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix.
Danish: Patienter med kendt eller mistænkt leversygdom har ikke været inkluderet i kliniske langtidsforsøg med degarelix.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes umiddelbart, er opbevaringstid og -betingelser for brug brugerens ansvar.
English: Powder Mannitol (E421)
Danish: Pulver Mannitol (E421)
English: From day 56 to day 364 there were no significant differences between degarelix and the comparator in the percentage change from baseline.
Danish: Fra dag 56 til dag 364 var der ingen signifikante forskelle mellem degarelix og komparatoren i den procentvise ændring fra udgangsniveau.
English: Attainment of serum testosterone (T) ≤0.5 ng/ml FIRMAGON is effective in achieving fast testosterone suppression, see Table 2.
Danish: Opnåelse af serumtestosteron (T) ≤0,5 ng/ml FIRMAGON er effektiv til at opnå en hurtig testosteronsuppression, se tabel 2.
English: The site of injection is likely to vary within the abdominal region.
Danish: Injektionsstedet varierer sandsynligvis inden for maveregionen.
English: Reduced level of testosterone may cause a reduction in bone calcium (thinning of bones).
Danish: Reduceret niveau af testosteron kan medføre en reduktion af calcium i knoglerne (udtynding af knoglerne).
English: − febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart failure
Danish: − febril neutropeni (meget lavt antal af hvide blodlegemer i kombination med feber), hjerteanfald,
English: On the basis of the scientific conclusions for degarelix the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing degarelix is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for degarelix er CHMP af den opfattelse, at benefit/riskforholdet for det lægemiddel/de lægemidler, der indeholder degarelix, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for one year and 29% of patients after treatment with FIRMAGON for up to 5.5 years.
Danish: Udvikling af anti-degarelix-antistof blev set hos 10% af patienterne efter behandling med FIRMAGON i et år og hos 29% af patienterne efter behandling med FIRMAGON i op til 5,5 år.
English: This medicine is stable for 2 hours at 25ºC.
Danish: Dette lægemiddel er stabilt i 2 timer ved 25ºC.
English: − discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction)
Danish: − ubehag ved injektion, inklusive fald i blodtryk og hjerterytme (vasovagal reaktion)
English: NOTE: • THE VIALS SHOULD NOT BE SHAKEN
Danish: BEMÆRK: • HÆTTEGLASSENE MÅ IKKE RYSTES
English: Cardiovascular disease such as stroke and myocardial infarction has been reported in the medical literature in patients with androgen deprivation therapy.
Danish: Kardiovaskulær sygdom såsom slagtilfælde og myokardieinfarkt er blevet rapporteret i den medicinske litteratur hos patienter med androgen kastrationsbehandling.
English: Effect on QT/QTc intervals
Danish: Virkning på QT/QTc-interval
English: In the confirmatory study comparing FIRMAGON to leuprorelin periodic electrocardiograms were performed.
Danish: I det bekræftende studie sammenlignende FIRMAGON med leuprorelin blev der foretaget periodiske elektrokardiogrammer.
English: Do not inject directly into a vein.
Danish: Injicér ikke direkte ind i en vene.
English: Prostate specific antigen (PSA) levels are lowered by 64% two weeks after administration of degarelix, 85% after one month, 95% after three months, and remained suppressed (approximately 97%) throughout the one year of treatment.
Danish: Prostata specifikt antigen (PSA) niveau er nedsat med 64% to uger efter administration af degarelix, 85% efter en måned, 95% efter tre måneder, og forblev undertrykt (ca. 97%) gennem hele behandlingslængden på et år.
English: A thorough QT study showed that there was no intrinsic effect of degarelix on QT/QTc interval (see section
Danish: Et grundigt QT-studie viste, at degarelix ikke havde nogen intrinsic effekt på QT/QTc-intervallet (se pkt.
English: Avoid shaking to prevent foam formation.
Danish: Undgå omrystning for at hindre skumdannelse.
English: The median PSA in the study at baseline was:
Danish: Den mediane PSA i studiet ved udgangsniveauet var:
English: A single dose of 240 mg degarelix, followed by a monthly maintenance dose of 80 mg, rapidly causes a decrease in the concentrations of LH, FSH and subsequently testosterone.
Danish: En enkelt dosis på 240 mg degarelix, efterfulgt af en månedlig vedligeholdelsesdosis på 80 mg, medfører hurtigt en nedsættelse af koncentrationerne af LH, FSH og efterfølgende af testosteron.
English: There is no relevant use of FIRMAGON in children and adolescents in the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Danish: Der er ingen relevant brug af FIRMAGON hos børn og unge til behandling af voksne mænd med fremskræden hormon-afhængig prostatakræft.
English: In healthy men, approximately 20-30% of a single intravenously administered dose is excreted in the urine, suggesting that 70-80% is excreted via the hepato-biliary system.
Danish: Hos raske mænd blev ca. 20-30% af en enkelt intravenøst administreret dosis udskilt i urinen, hvilket tyder på, at 70-80% udskilles via lever-galde systemet.
English: Prostatic carcinoma is known to be androgen sensitive and responds to treatment that removes the source of androgen.
Danish: Prostatakræft er kendt for at være sensitiv over for androgener og responderer på behandling, der fjerner kilden til androgener.
English: 80 mg administered as one subcutaneous injection
Danish: 80 mg administreret som én subkutan injektion
English: Changes in ECG measurements
Danish: Ændringer i ekg
English: These events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, the incidence of these events pr 100 injections was: 3 for pain and <1 for erythema, swelling, nodule and induration.
Danish: Disse bivirkninger forekom primært ved startdosis, mens frekvensen af disse pr. 100 injektioner under vedligeholdelsesbehandling med en dosis på 80 mg var: 3 for smerte og <1 for erythem, hævelse, knuder og induration.
English: Only about 20-30% of a given dose of degarelix is excreted unchanged by the kidneys.
Danish: Kun omkring 20-30% af en given dosis af degarelix udskilles uomdannet via nyrerne.
English: In each case degarelix was discontinued.
Danish: I alle tilfældene blev degarelix seponeret.
English: Bilirubin increased, alkaline phosphatase increased
Danish: Øget bilirubin-niveau, øget basisk fosfatase
English: Table 3: Cumulative probability of testosterone ≤0.5 ng/ml from Day 28 to Day 364.
Danish: Tabel 3: Kumulativ sandsynlighed for testosteron ≤0.5 ng/ml fra dag 28 til dag 364.
English: FIRMAGON must be injected under the skin (subcutaneously) ONLY.
Danish: FIRMAGON må KUN injiceres under huden (subkutant).
English: In 4 of the 8 cases, the causal relationship between degarelix and the event could not be ruled out; the cases were well documented, without evident alternative aetiology or confounding factors, with compatible time-to-onset and positive dechallenge and increased blood CPK.
Danish: I 4 af de 8 tilfælde kunne den kausale sammenhæng mellem degarelix og bivirkningen ikke udelukkes; tilfældene var veldokumenterede, uden en åbenbar alternativ ætiologi eller forstyrrende faktorer, med overensstemmelse mellem tid til indtræden, positivt udfald ved seponering (positiv dechallenge) og forhøjet blod-kreatinin-fosfokinase.
English: Table 1: Frequency of adverse drug reactions reported in 1,259 patients treated for a total of 1781 patient years (phase II and III studies) and from post-marketing reports
Danish: Tabel 1: Frekvens af bivirkninger rapporteret hos 1.259 patienter, der blev behandlet i 1.781 patientår i alt (fase II- og III-studier) og fra post-marketing rapporter.
English: Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its effects.
Danish: Degarelix efterligner et naturligt hormon (gonadotropinfrigørende hormon, GnRH) og blokerer direkte for dets virkninger.
English: No formal drug-drug interaction studies have been performed.
Danish: Der er ikke udført interaktionsstudier.
English: The European Medicines Agency has waived the obligation to submit the results of studies with FIRMAGON in all subsets of the paediatric population (see section 4.2 for information on paediatric use).
Danish: Det europæiske Lægemiddelagentur har dispenseret fra kravet om indsendelse af resultater fra studier med FIRMAGON i alle undergrupper af den pædiatriske population (se pkt.
English: No significant metabolites were detected in plasma samples after subcutaneous administration.
Danish: Ingen signifikante metabolitter sås i plasmaprøver efter subkutan administration.
English: Transient chills, fever or influenza like illness were reported to occur hours after dosing (in 3%, 2% and 1% of patients, respectively).
Danish: Forbigående kuldegysninger, feber eller influenzalignende sygdom blev rapporteret at forekomme timer efter doseringen (hos henholdsvis 3%, 2% og 1% af patienterne).
English: The reconstituted solution should be a clear liquid, free of undissolved matter.
Danish: Den rekonstituerede opløsning skal være en klar væske, fri for uopløst stof.
English: Myocardial infarction, cardiac failure
Danish: Myokardieinfarkt, hjertesvigt
English: Unlike GnRH agonists, GnRH antagonists do not induce a LH surge with subsequent testosterone surge/tumour stimulation and potential symptomatic flare after the initiation of treatment.
Danish: I modsætning til GnRH-agonister, inducerer GnRH-antagonister ikke en initial stimulation af LH med efterfølgende initial stimulation af testosteron/tumorstimulering og potentiel symptomatisk opblussen efter start af behandlingen.
English: Table 2: Percentage of patients attaining T≤0.5 ng/ml after start of treatment.
Danish: Tabel 2: Procent of patienter, der opnåede T≤0,5 ng/ml efter start af behandlingen.
English: Pharmacotherapeutic group: Endocrine therapy, Other hormone antagonists and related agents, ATC code: L02BX02
Danish: Farmakoterapeutisk klassifikation: Endokrin terapi, Andre hormonantagonister og beslægtede stoffer, ATC-kode: L02BX02
English: FIRMAGON is administered as a subcutaneous injection in the abdominal region.
Danish: FIRMAGON administreres som en subkutan injektion i maveregionen.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Danish: Frekvensen af de bivirkninger, der er nævnt nedenfor er defineret i henhold til følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: By doing so, degarelix immediately reduces the level of the male hormone testosterone that stimulates the prostate cancer.
Danish: Hermed nedsætter degarelix øjeblikkeligt niveauet af det mandlige hormon testosteron, som stimulerer prostatakræften.
English: In the degarelix 240/80 mg treatment group 41 (20%) patients discontinued the study, as compared to 32 (16%) patients in the leuprorelin group.
Danish: I degarelix 240/80 mg behandlingsgruppen afbrød 41 (20%) patienter studiet, sammenlignet med 32 (16%) patienter i leuprorelin gruppen.
English: Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes.
Danish: Degarelix er en selektiv gonadotropinfrigørende hormon (GnRH)-antagonist som kompetitivt og reversibelt binder til de hypofysære GnRH receptorer, og herved hurtigt nedsætter frigørelsen af gonadotropiner, luteiniserende hormon (LH) og follikelstimulerende hormon (FSH) og dermed reducerer sekretionen af testosteron (T) fra testiklerne.
English: − chills, fever or influenza-like illness after the injection
Danish: − kuldegysninger, feber eller influenzalignende sygdom efter injektionen
English: Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ml.
Danish: Succesfuldt respons i studiet blev defineret som opnåelse af medicinsk kastration på dag 28 og vedligeholdelse til og med dag 364 uden en enkelt testosteronkoncentration på over 0,5 ng/ml.
English: Precautions must be taken to avoid accidental injection into a vein.
Danish: Forsigtighedsregler skal tages for at undgå injektion ind i en blodåre ved en fejl.
English: Effect on prostate volume
Danish: Virkning på prostatavolumen
English: Plasma protein binding is estimated to be approximately 90%.
Danish: Plasmaproteinbinding er estimeret til at være ca.