FrancophonIA/ELRC3.0 huggingface dataset:
English: Mannitol (E421), water for injections
Danish: LISTE OVER HJÆLPESTOFFER Mannitol (E421), vand til injektionsvæsker
English: • Risk Management Plan (RMP)The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: *Known physiological consequence of testosterone suppression
Danish: *Kendt fysiologisk konsekvens af testosteronsuppression Beskrivelse af udvalgte bivirkninger
English: − Severe hypersensitivity.
Danish: - Alvorlig hypersensitivitet.
English: Since degarelix does not induce a testosterone surge it is not necessary to add an anti-androgen as surge protection at initiation of therapy.
Danish: Idet degarelix ikke inducerer en initial stimulation af testosteron, er det ikke nødvendigt at tilføre et antiandrogent stof som beskyttelse mod initial stimulation ved behandlingsstart.
English: Powder and solvent for solution for injection Powder: White to off-white powder Solvent: Clear, colourless solution
Danish: LÆGEMIDDELFORM Pulver og solvens til injektionsvæske, opløsning Pulver: Hvidt til off-white pulver Solvens: Klar, farveløs opløsning
English: Baseline demographics were similar between the arms.
Danish: Demografien ved start af forsøget var ens mellem armene.
English: FIRMAGON has not been studied in patients with a history of a corrected QT interval over 450 msec, in patients with a history of or risk factors for torsades de pointes and in patients receiving concomitant medicinal products that might prolong the QT interval.
Danish: FIRMAGON er ikke undersøgt hos patienter med tidligere korrigeret QT-interval over 450 msek., hos patienter, som tidligere har oplevet eller som har risikofaktorer for torsades de pointes og hos patienter, der samtidigt modtager lægemidler, som kan forlænge QT-intervallet.
English: Degarelix has not been studied in patients with a history of severe untreated asthma, anaphylactic reactions or severe urticaria or angioedema.
Danish: Degarelix er ikke undersøgt hos patienter med alvorlig ubehandlet astma, anafylaktiske reaktioner eller alvorlig urticaria eller angioødem i anamnesen.
English: The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels.
Danish: Den terapeutiske effekt af degarelix skal monitoreres ved kliniske parametre og ved prostata specifikt antigen (PSA)-niveau i serum.
English: Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the starting dose with 96% of the patients having serum testosterone levels corresponding to medical castration (T≤0.5 ng/ml) after three days and 100% after one month.
Danish: Kliniske studier har vist, at testosteron (T)-suppression sker umiddelbart efter administration af startdosis, hvor 96% af patienterne havde serum-testosteron svarende til niveauet ved medicinsk kastration (T≤0,5 ng/ml) efter 3 dage og 100% efter 1 måned.
English: Degarelix is not a substrate for the human CYP450 system and has not been shown to induce or inhibit CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 to any great extent in vitro.
Danish: Degarelix er ikke et substrat for det humane CYP450-system og har ikke induceret eller hæmmet CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4/5 i nævneværdig grad in vitro.
English: Hyperhidrosis (incl.
Danish: Hyperhidrose (inkl.
English: Surge was defined as testosterone exceeding baseline by ≥15% within the first 2 weeks.
Danish: Initial stimulation blev defineret ved, at testosteron oversteg udgangsniveauet med ≥15% inden for de første 2 uger.
English: The serum concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone.
Danish: Serumdihydrotestosteron (DHT) nedsættes på en lignende måde som testosteron.
English: − excessive sweating (including night sweats), rash
Danish: − øget svedtendens (inklusiv natlige svedeture), udslæt
English: The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone suppression, including hot flushes and weight increase (reported in 25% and 7%, respectively, of patients receiving treatment for one year), or injection site adverse reactions.
Danish: De mest almindelige bivirkninger ved brug af degarelix i det bekræftende fase III-studie (N=409) skyldtes de forventede fysiologiske virkninger af testosteronsuppression, inklusiv hedeture og vægtøgning (rapporteret hos henholdsvis 25% og 7% af de patienter, der modtog behandling i 1 år) eller reaktioner ved injektionsstedet.
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Spørg lægen, hvis du har yderligere spørgsmål om brug af dette lægemiddel.
English: If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly.
Danish: Hvis pulver sætter sig fast til hætteglasset over væskeoverfladen, kan hætteglasset vippes lidt.
English: Degarelix is subject to common peptidic degradation during the passage of the hepato-biliary system and is mainly excreted as peptide fragments in the faeces.
Danish: Degarelix undergår almindelig peptidnedbrydning under passagen af lever-galde systemet og udskilles hovedsageligt som peptidfragmenter i fæces.
English: Median testosterone levels after one year of treatment were 0.087 ng/ml (interquartile range 0.06-0.15) N=167.
Danish: Mediane testosteronniveauer var efter et års behandling på 0,087 ng/ml (interkvartil variationsbredde 0,06-0,15), N=167.
English: − depression, mental impairment
Danish: − depression, mental svækkelse
English: Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 97% of patients for at least one year.
Danish: En månedlig vedligeholdelsesdosis på 80 mg resulterede i vedvarende testosteron suppression hos 97% of patienterne i mindst et år.
English: No testosterone microsurges were observed after re-injection during degarelix treatment.
Danish: Der blev ikke set mikrostigninger af testosteron efter gen-injektion under degarelixbehandling.
English: 56.5 ng/ml)
Danish: P75 56,5 ng/ml)
English: Serious injection site reactions were very rarely reported such as injection site infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage.
Danish: Alvorlige reaktioner på injektionsstedet så som infektion på injektionsstedet, absces på injektionsstedet eller nekrose på injektionsstedet, som vil kunne kræve kirurgisk behandling/dræn, blev rapporteret meget sjældent.
English: Use of FIRMAGON has not been investigated in patients with severe hypersensitivity reactions.
Danish: Brug af FIRMAGON er ikke undersøgt hos patienter med alvorlige hypersensitivitetsreaktioner.
English: To do so: grasp the skin of the abdomen, elevate the subcutaneous tissue and insert the needle deeply at an angle of not less than 45 degrees.
Danish: Tag fat i maveskindet, løft op i det subkutane væv og indfør nålen dybt i en vinkel på mindst 45 grader.
English: Mean trough values were approximately 11-12 ng/ml after the starting dose and 11-16 ng/ml after maintenance dosing of 80 mg at a concentration of 20 mg/ml.
Danish: Gennemsnitlige through værdier var ca. 1112 ng/ml efter startdosis og 11-16 ng/ml efter vedligeholdelsesdosis på 80 mg ved en koncentration på 20 mg/ml.
English: Special populations
Danish: Specielle grupper
English: 240 mg administered as two consecutive subcutaneous injections of 120 mg each
Danish: 240 mg administreret som to efterfølgende subkutane injektioner af hver 120 mg
English: Three months therapy with degarelix (240/80 mg dose regimen) resulted in a 37% reduction in prostate volume as measured by trans-rectal ultrasound scan (TRUS) in patients requiring hormonal therapy prior to radiotherapy and in patients who were candidates for medical castration.
Danish: Tre måneders behandling med degarelix (240/80 dosisregime) resulterede i en reduktion på 37% i prostatavolumen målt med trans-rektal ultralydsskanning (TRUS) hos patienter, hvor hormonbehandling var nødvendig forud for strålebehandling, og hos patienter, som var kandidater til medicinsk kastration.
English: Cardiac arrhythmia (incl.
Danish: Hjertearytmi (inkl.
English: SC use only
Danish: Kun til s.c. anvendelse
English: België/Belgique/Belgien
Danish: België/Belgique/Belgien Ferring N.V.
English: Tel. +45 8833 8834
Danish: Tlf. +45 8833 8834
English: Drug-related local irritation was noted in animals when degarelix was administered subcutaneously in high doses.
Danish: Der sås lægemiddelrelateret lokalirritation hos dyr, når degarelix blev administreret subkutant i høje doser.
English: Date of first authorisation: 17/02/2009 Date of latest renewal: 19/09/2013
Danish: Dato for seneste fornyelse: 19/09/2013
English: Cardiovascular disease
Danish: Kardiovaskulær sygdom
English: The primary end-point in the study was testosterone suppression rates after one year of treatment with degarelix or leuprorelin.
Danish: Studiets primære endemål var testosteron suppressionsværdierne efter et års behandling med degarelix eller leuprorelin.
English: − unexplained muscular pain or cramps, tenderness, or weakness.
Danish: − uforklarlige muskelsmerter eller kramper, ømhed eller svaghed.
English: Long term treatment with the maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels (T≤0.5 ng/ml).
Danish: Langtidsbehandling med vedligeholdelsesdosis i op til 1 år viser, at 97% af patienterne stadig har et sænket testosteronniveau (T≤0,5 ng/ml).
English: 8 cases of rhabdomyolysis have cumulativly been reported with degarelix.
Danish: Der er kumulativt blevet indberettet 8 tilfælde af rabdomyolyse for degarelix.
English: Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients.
Danish: Degarelix er en syntetisk hormonblokker, der anvendes til behandling af prostatakræft hos voksne mænd.
English: − The other ingredient of the powder is mannitol (E 421).
Danish: - Øvrigt indholdsstof i pulveret er mannitol (E421).
English: FIRMAGON has no or negligible influence on the ability to drive and use machines.
Danish: FIRMAGON påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: − Osteoporosis or any condition that affects the strenght of your bones.
Danish: - Du har knogleskørhed eller en tilstand, der påvirker styrken af dine knogler.
English: A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
Danish: Der er set en nedsat glukosetolerance hos mænd, som har haft orchiektomi eller som har været behandlet med en GnRH-agonist.
English: Тел: +359 2 807 5022 aquachim@aquachim.bg
Danish: Tел: +359 2 807 5022 aquachim@aquachim.bg
English: night sweats)*, rash
Danish: natlige svedeture)*, udslæt
English: Attainment of prostate specific antigen (PSA) reduction Tumour size was not measured directly during the clinical trial programme, but there was an indirect beneficial tumour response as shown by a 95% reduction after 12 months in median PSA for degarelix.
Danish: Tumorstørrelse blev ikke målt direkte under det kliniske forsøg, men der sås et indirekte fordelagtigt tumorrespons med degarelix som vist med en 95% reduktion efter 12 måneder i median PSA.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal produktet anvendes umiddelbart, medmindre metoden for rekonstituering kan udelukke risikoen for mikrobiologisk kontaminering.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ}.
English: Cmax degarelix plasma concentration decreases in a biphasic fashion, with a mean terminal half-life (t½) of 29 days for the maintenance dose.
Danish: Degarelix-Cmax falder bifasisk med en gennemsnitlig terminal halveringstid (t½) på 29 dage for vedligeholdelsesdosis.
English: The study investigated the efficacy and safety of two different degarelix monthly dosing regimens with a starting dose of 240 mg (40 mg/ml) followed by monthly doses subcutaneous administration of 160 mg (40 mg/ml) or 80 mg (20 mg/ml), in comparison to monthly intramuscular administration of 7.5 mg leuprorelin in patients with prostate cancer requiring androgen deprivation therapy.
Danish: Studiet undersøgte effekten og sikkerhed af to forskellige månedlige doseringsregimer af degarelix med en startdosis på 240 mg (40 mg/ml) efterfulgt af månedlige subkutane doser på 160 mg (40 mg/ml) eller 80 mg (20 mg/ml), sammenlignet med månedlig intramuskulær administration af 7,5 mg leuprorelin hos patienter med prostatakræft, der krævede androgen deprivationsbehandling.
English: • 29% had locally advanced prostate cancer
Danish: • 29% regionalt avanceret prostatakræft
English: Depression, libido decreased*
Danish: Depression, nedsat libido*
English: None of the degarelix-treated patients experienced a testosterone surge; there was an average decrease of 94% in testosterone at day 3.
Danish: Ingen af de patienter, der blev behandlet med degarelix oplevede en initial stimulation af testosteron ; der var en gennemsnitlig nedsættelse af testosteron på 94% på dag 3.
English: − frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at night, impaired renal function, incontinence
Danish: − hyppig vandladning, vandladningstrang (må skynde sig for at lade vandet), vanskelig eller smertefuld vandladning, natlig vandladning, nedsat nyrefunktion, inkontinens
English: Animal reproduction studies showed that degarelix caused infertility in male animals.
Danish: Reproduktionsstudier hos dyr viste, at degarelix medførte infertilitet hos hanner.
English: Development or aggravation of diabetes may occur; therefore diabetic patients may require more frequent monitoring of blood glucose when receiving androgen deprivation therapy.
Danish: Derfor kan diabetiske patienter kræve hyppigere monitorering af blodglukose, når de får androgen deprivationsbehandling.
English: Ferring Slovakia s.r.o.
Danish: Slovenská republika Ferring Slovakia s.r.o.
English: Markedly abnormal values of potassium (≥5.8 mmol/l), creatinine (≥177 μmol/l) and BUN (≥10.7 mmol/l) in patients with normal values prior to treatment, were seen in 6%, 2% and 15% of degarelix treated patients and 3%, 2% and 14% of leuprorelin treated patients, respectively.
Danish: Markant unormale værdier af kalium (≥5,8 mm/l), kreatinin (≥177 μmol/l) og BUN (≥10,7 mmol/l) sås hos patienter, der havde normale værdier før behandling hos henholdsvis 6%, 2% og 15% af de patienter, der blev behandlet med degarelix og 3%, 2% og 14% af de patienter, der blev behandlet med leuprorelin.
English: Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ml to prostate cancer patients in the pivotal study CS21, AUC0-28 days was 635 (602-668) day*ng/ml, Cmax was 66.0 (61.071.0) ng/ml and occurred at tmax at 40 (37-42) hours.
Danish: Efterfølgende subkutan administration af 240 mg degarelix ved en koncentration på 40 mg/ml til patienter med prostatakræft i det pivotale studie CS21, var AUC0-28 days 635 (602-668) dag*ng/ml, Cmax var 66,0 (61,0-71,0) ng/ml og forekom ved tmax ved 40 (37-42) timer.
English: Most of the leuprorelin-treated patients experienced testosterone surge; there was an average increase of 65% in testosterone at day 3.
Danish: De fleste patienter behandlet med leuprorelin oplevede initial stimulation af testosteron; der var en gennemsnitlig øgning af testosteron på 65% på dag 3.
English: Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ml.
Danish: Degarelix er effektiv til at nå og vedligeholde testosteronsuppression et godt stykke under medicinsk kastrationsniveau på 0,5 ng/ml.
English: Musculoskeletal pain and discomfort
Danish: Muskuloskeletale smerter og ubehag
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til FIRMAGON
English: No signs of increased exposure in the hepatically impaired subjects were observed compared to healthy subjects.
Danish: Der sås ikke tegn på øget eksponering hos dem med nedsat leverfunktion sammenlignet med raske forsøgspersoner.
English: Very common (may affect more than 1 in 10 people) Hot flushes, injection site pain and redness.
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 brugere) Hedeture, smerter og rødme ved injektionsstedet.
English: FIRMAGON is available in 2 pack-sizes:
Danish: FIRMAGON findes i 2 pakningsstørrelser:
English: Figure 1: Percentage change in testosterone from baseline by treatment group until day 28 (median with interquartile ranges).
Danish: Figur 1: Procentvis ændring i testosteron fra udgangsniveauet ved behandlingsgrupperne indtil dag 28 (median med interkvartile variationsbredder).
English: Anti-degarelix antibodies
Danish: Anti-degarelix-antistof
English: There is no need to adjust the dose for the elderly or in patients with mild or moderate liver or kidney function impairment (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos ældre patienter eller hos patienter med let til moderat nedsat lever- eller nyrefunktion (se pkt.
English: Perform a deep subcutaneous injection.
Danish: Injicer dybt subkutant.
English: This is due to the pharmacological effect; and the effect was reversible.
Danish: Dette skyldes den farmakologiske virkning.
English: − The solvent is water for injections.
Danish: - Solvensen er vand til injektionsvæsker.
English: With the syringe still attached to the adapter, swirl gently until the liquid looks clear and without undissolved powder or particles.
Danish: Med sprøjten stadig fastgjort til adapteren roteres hætteglasset varsomt, indtil opløsningen er klar og uden uopløst pulver eller partikler.
English: Chills, pyrexia, fatigue*, Influenzalike illness
Danish: Kuldegysninger, pyrexi, træthed*, influenzalignende sygdom
English: The primary objective was to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to below 0.5 ng/ml, during 12 months of treatment.
Danish: Hovedmålet var at demonstrere, at degarelix er effektivt i forhold til at nå og opretholde testosteron suppression på under 0,5 ng/ml i løbet af 12 måneders behandling.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.emea.europa.eu/.
English: • 31% had localised prostate cancer
Danish: • 31% lokaliseret prostatakræft
English: Bone density has not been measured during treatment with degarelix.
Danish: Knogledensiteten er ikke målt under behandling med degarelix.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.emea.europa.eu/.
English: − Diabetes mellitus.
Danish: - Du har sukkersyge (diabetes mellitus).
English: If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor.
Danish: Fortæl det til din læge, hvis du tror, at din månedlige dosis af FIRMAGON er blevet glemt.
English: Day 14 Day 28
Danish: Dag 28
English: Figure 2: Percentage change in PSA from baseline by treatment group until day 56 (median with interquartile ranges).
Danish: Figur 2: Procentvis ændring i PSA fra udgangsniveau ved behandlingsgrupperne indtil dag 56 (median med interkvartile variationsbredder).
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 brugere)
English: In female reproduction toxicity studies degarelix revealed findings expected from the pharmacological properties.
Danish: I kvindelige reproduktionstoksicitetsstudier viste degarelix forventede fund i forhold til de famakologiske egenskaber.
English: A population pharmacokinetics analysis of the data from the confirmatory Phase III study has demonstrated that the clearance of degarelix in patients with mild to moderate renal impairment is reduced by approximately 23%; therefore, dose adjustment in patients with mild or moderate renal impairment is not recommended.
Danish: En farmakokinetisk analyse af data fra det bekræftende fase III-studie har vist, at clearance af degarelix er reduceret med ca. 23% hos patienter med mild til moderat nedsat nyrefunktion.
English: • 20% had metastatic prostate cancer
Danish: • 20% metastaserende prostatakræft
English: Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Danish: Kemisk og fysisk stabilitet i brug er vist i 2 timer ved 25ºC.
English: Degarelix has been investigated in a pharmacokinetic study in patients with mild to moderate hepatic impairment.
Danish: Degarelix er undersøgt i et farmakokinetisk studie hos patienter med mild til moderat nedsat leverfunktion.
English: Injection needles (25G 0.5 x 25 mm)
Danish: Injektionskanyler (25G, 0,5 x 25 mm)
English: The pharmacokinetics of degarelix has been investigated after single intravenous administration in subjects with mild to moderate hepatic impairment (see section 5.2).
Danish: Farmakokinetikken af degarelix er undersøgt efter en enkelt intravenøs administration hos personer med mild til moderat leverfunktionsnedsættelse (se pkt.
English: FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
Danish: FIRMAGON er en antagonist til det gonadotropinfrigørende hormon (GnRH), og er indiceret til behandling af voksne mænd med fremskræden hormon-afhængig prostatakræft.
English: Effect on QT/QTc interval Long-term androgen deprivation therapy may prolong the QT interval.
Danish: Langtids-deprivationsbehandling med androgen kan forlænge QT-intervallet.
English: Gently pull back the plunger to check if blood is aspirated.
Danish: Træk sprøjtestemplet forsigtigt tilbage for at kontrollere, om der bliver suget blod med op.
English: Pack-size of 3 trays containing:
Danish: Pakningsstørrelse med 3 bakker indeholder:
English: Use of FIRMAGON has not been investigated in patients with severe kidney disease.
Danish: Brug af FIRMAGON er ikke undersøgt hos patienter med alvorlig nyresygdom.
English: Both therapies showed QT/QTc intervals exceeding 450 msec in approximately 20% of the patients.
Danish: Begge behandlingsformer viste QT/QTc-intervaller, der oversteg 450 msek.
English: From baseline to end of study the median change for FIRMAGON was 12.0 msec and for leuprorelin it was 16.7 msec.
Danish: Fra udgangsniveauet til slutningen af studiet var den mediane ændring for FIRMAGON 12,0 msek., og for leuprorelin var den 16,7 msek.
English: 2 injection needles
Danish: 2 injektionskanyler
English: Vistor hf. Sími: +354 535 70 00
Danish: Sími: +354 535 70 00
English: Mild, transient increases in ALT and AST have been seen, these were not accompanied by a rise in bilirubin or clinical symptoms.
Danish: Dette var ikke ledsaget af en stigning i bilirubin eller kliniske symptomer.
English: − increased weight, nausea, diarrhoea, elevated levels of some liver enzymes
Danish: − vægtøgning, kvalme, diarré, forhøjet niveauer af visse leverenzymer
English: Pack-size of 1 tray containing:
Danish: Pakningsstørrelse med 1 bakke indeholder: