natgillin/translations-raw huggingface dataset:
Kliniske forsøg har vist, at testosteron (T) - suppression sker umiddelbart efter administration af startdosis, hvor 96% af patienterne havde et plasmatestosteronniveau svarende til niveauet ved medicinsk kastration (T≤0, 5 ng/ ml) efter 3 dage og 100% efter 1 måned.
Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the starting dose with 96% of the patients having plasma testosterone levels corresponding to medical castration (T≤ 0.5 ng/ ml) after three days and 100% after one month.
Langtidsbehandling med vedligeholdelsesdosis i op til 1 år viser, at 97% af patienterne stadig har et sænket testosteronniveau (T≤0, 5 ng/ ml).
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).
I tilfælde af at patientens kliniske respons er sub- optimalt, skal det bekræftes, at testosteronniveauet i serum stadig er tilstrækkeligt sænket.
In case the patient's clinical response appears to be sub-optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed.
Indgivelsesmåde FIRMAGON skal opløses før administration.
Method of administration FIRMAGON must be reconstituted prior to administration.
6. 6.
For instructions on reconstitution and administration, please see section 6.6.
Må ikke administreres intravenøst.
Subcutaneous use ONLY, not to be administered intravenously.
Intramuskulær brug er ikke undersøgt og frarådes derfor.
2 Intramuscular administration is not recommended as it has not been studied.
Ligesom med andre lægemidler, der administreres ved subkutan injektion, bør injektionsstedet varieres periodisk.
As with other medicinal products administered by subcutaneous injection, the injection site should vary periodically.
Injektionerne skal gives i områder, hvor patienten ikke er udsat for tryk, f. eks. ikke tæt på bukselinning eller bæltested og ikke tæt på ribbenene.
Injections should be given in areas where the patient will not be exposed to pressure e. g. not close to waistband or belt and not close to the ribs.
Specifikke patientgrupper Ældre, patienter med nedsat lever - eller nyrefunktion:
Special patient populations Elderly, hepatically or renally impaired patients:
5. 2).
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).
4. 4).
Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted (see section 4.4).
Der er ingen relevante indikationer for brug af FIRMAGON til kvinder, børn og unge.
There is no relevant indication for use of FIRMAGON in women, children and adolescents.
De tilgængelige data vedrørende effekt og sikkerhedserfaring med degarelix er begrænset til et års behandling.
The data available on efficacy and safety experience with degarelix is limited to a one year treatment.
Virkning på QT/ QTc- interval Langtids- deprivationsbehandling med androgen kan forlænge QT- intervallet.
Effect on QT/ QTc interval Long-term androgen deprivation therapy may prolong the QT interval.
I det bekræftende forsøg, hvor FIRMAGON blev sammenlignet med leuprorelin, blev der foretaget periodiske (månedlige) EKG’ er.
In the confirmatory study comparing FIRMAGON to leuprorelin periodic (monthly) ECGs were performed; both therapies showed QT/ QTc intervals exceeding 450 msec in approximately 20% of the patients, and 500 msec in 1% and 2% of the degarelix and leuprorelin patients, respectively (see section 5.1).
5. 1).
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.
4. 5 og 4. 8).
Therefore in such patients, the benefit/ risk ratio of FIRMAGON must be thoroughly appraised (see sections 4.5 and 4.8).
Nedsat leverfunktion Patienter med kendt eller mistænkt leversygdom har ikke været inkluderet i kliniske langtidsforsøg med degarelix.
Hepatic impairment Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix.
5. 2).
The pharmacokinetics of degarelix has been investigated after single intravenous administration in subjects with mild to moderate hepatic impairment (see section 5.2).
Nedsat nyrefunktion Degarelix er ikke undersøgt hos patienter med stærkt nedsat nyrefunktion, og forsigtighed bør derfor udvises.
Renal impairment Degarelix has not been studied in patients with severe renal impairment and caution is therefore warranted.
Hypersensitivitet Degarelix er ikke undersøgt hos patienter med alvorlig ubehandlet astma, anafylaktiske reaktioner eller alvorlig nældefeber eller angioødem i anamnesen.
Hypersensitivity Degarelix has not been studied in patients with a history of severe untreated asthma, anaphylactic reactions or severe urticaria or angioedema.
Det kan forventes, at lange perioder med
Changes in bone density Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH agonist.
3 testosteronundertrykkelse hos mænd vil have en virkning på knogledensiteten.
It can be anticipated that long periods of testosterone suppression in men will have effects on bone density.
Glukosetolerance Der er set en nedsat glukosetolerance hos mænd, som har haft orchiektomi eller som har været behandlet med en GnRH- agonist.
3 A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
Virkningen af degarelix på insulin - og glukoseniveau er ikke undersøgt.
The effect of degarelix on insulin and glucose levels has not been studied.
Der er ikke udført interaktionsundersøgelser.
No formal drug-drug interaction studies have been performed.
4. 4).
Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes such as class IA (e. g. quinidine, disopyramide) or class III (e. g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, cisapride, moxifloxacine, antipsychotics, etc. should be carefully evaluated (see section 4.4).
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.
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.
Der er ikke foretaget undersøgelser af virkningen af degarelix på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects of degarelix on the ability to drive and use machines have been performed.
Dog er træthed og svimmelhed almindeligt forekommende bivirkninger, som kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
However, fatigue and dizziness are common adverse reactions that might influence the ability to drive and use machines.
De mest almindelige bivirkninger ved brug af degarelix i det bekræftende fase III- forsøg (N=409) skyldtes de forventede fysiologiske virkninger af testosteron suppression, inklusiv hedeture og vægtøgning (rapporteret hos henholdsvis 25% og 7% af de patienter, der modtog behandling i 1 år) eller bivirkninger ved injektionsstedet.
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 events.
Mindre hyppigt rapporteret var hævelse (6%), induration (4%) og knuder (3%).
The injection site adverse events reported were mainly pain and erythema, reported in 28% and 17% of patients, respectively, less frequently reported were swelling (6%), induration (4%) and nodule (3%).
100 injektioner under vedligeholdelsesbehandling med en dosis på 80 mg var:
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 smerte og < 1 for erythem, hævelse, knuder og induration.
3 for pain and < 1 for erythema, swelling, nodule and induration.
De rapporterede bivirkninger var primært forbigående, af mild til moderat intensitet og førte til meget få seponeringer (< 1%).
The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (< 1%).
Frekvensen af de bivirkninger, der er nævnt nedenfor er defineret i henhold til følgende konvention:
The frequency of undesirable effects listed below is defined using the following convention:
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100).
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100).
Frekvens af bivirkninger rapporteret i bekræftende fase III- forsøg (N=409).
Frequency of adverse drug reactions reported in confirmatory phase III study (N=409).
4 MedDRA system - organklasse (SOC) Blod og lymfesystem Immunsystemet Metabolisme og ernæring
MedDRA System Organ Class (SOC)
Ikke almindelig Anæmi * Hypersensitivitet Nedsat appetit
Blood and lymphatic system disorders
Psykiske forstyrrelser
Immune system disorders
Søvnløshed
Hypersensitivity
Nedsat libido *, depression, angst
Metabolism and nutrition disorders
Nervesystemet
Appetite decreased
Svimmelhed, hovedpine
Insomnia Dizziness, headache
Øre og labyrint Hjerte
Ear and labyrinth disorders
Tinnitus Atrio- ventrikulært blok af 1. grad QT- forlængelse * (se pkt.
Tinnitus
4. 4 og 4. 5)
Cardiac disorders
Hedeture *
Hot flush*
Hypertension, vasovagal synkope, åreknuder
Hypertension, vasovagal syncope, varicose vein
Luftveje, thorax og mediastinum
Respiratory, thorasic and mediastinal disorders
Diarré, opkastning, abdominalt ubehag, mundtørhed, forstoppelse
Diarrhoea, vomiting, abdominal discomfort, dry mouth, constipation
Forhøjede lever transaminaser
Liver transaminases increased
Hyperhidrose (inkl. natlige svedeture) *
Hyperhidrosis (incl. night sweats)*
Nældefeber, hyperpigmentation af huden, hårtab, bløde negle, udslæt, erythem
Urticaria, skin hyperpigmentation, allopecia, soft nails, rash, erythema
Knogler, led, muskler og bindevæv Nyrer og urinveje
Musculoskeletal, connective tissue and bone disorders
Muskuloskeletale smerter, muskelsvaghed Pollakisuri, vandladningstrang, nedsat nyrefunktion
Musculoskeletal pain, muscular weakness
Det reproduktive system og mammae
Renal and urinary disorders Reproductive system and breast disorders
Erektil dysfunktion *, testikulær atrofi *, gynækomasti *, bækkensmerter, prostatitis, prostata ømhed, retrograd ejakulation, testikelsmerter
Pollakiuria, micturition urgency, renal impairment Erectile dysfunction*, testicular atrophy*, gynaecomastia*, pelvic pain, prostatitis, prostate tenderness, retrograde ejaculation, testicular pain
Bivirkninger ved injektionsstedet
Injection site adverse events
Kuldegysninger, pyrexi, asteni, træthed *, influenzalignende sygdom
Chills, pyrexia, asthenia, fatigue*, Influenza-like illness
Lokale ødemer
Localised oedema
Vægtøgning *
Weight increased*
* Kendt fysiologisk konsekvens af testosteron suppression
*Known physiological consequence of testosterone suppression
Ændringer i laboratorieparametre Ændringerne i de laboratorieværdier, der sås gennem 1 års behandling var i samme størrelsesorden for degarelix som for en GnRH- agonist (leuprorelin), der blev anvendt som komparator.
Changes in laboratory parameters Changes in laboratory values seen during one year of treatment were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator.
For begge lægemidler sås markant unormale (> 3* øvre grænse for normalværdi) levertransaminaseværdier (ALAT, ASAT og GGT) efter behandling hos 2- 6% af de patienter, der havde normale værdier før behandlingen.
Markedly abnormal (> 3*ULN) liver transaminase values (ALT, AST and GGT) were seen in 2-6% of patients with normal values prior to treatment, following treatment with both medicinal products.
Der sås efter behandlingen markant nedsættelse af hæmatologiske værdier, hæmatokrit (≤0, 37) og hæmoglobin (≤115 g/ l) for begge lægemidler hos henholdsvis 40% og 13- 15% af de patienter, der havde normale værdier før behandling.
Marked decrease in haematological values, hematocrit (≤ 0.37) and hemoglobin (≤ 115 g/ l) were seen in 40% and 13-15%, respectively, of patients with normal values prior to treatment, following treatment with both medicinal products.
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
Markedly abnormal values of potassium (≥ 5.8 mmol/ l), creatinine (≥ 177 μ mol/ l) and BUN (≥ 10.7 mmol/ l) in patients with
5 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.
5 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.
Ændringer i EKG- målinger De ændringer, der blev set i EKG- målinger i løbet af et års behandling var i den samme størrelsesorden for degarelix som for en GnRH- agonist (leuprorelin), der blev anvendt som komparator.
Changes in ECG measurements Changes in ECG measurements seen during one year of treatment were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator.
Tre (< 1%) ud af 409 patienter i degarelix gruppen og fire (2%) ud af 201 patienter i leuprorelin 7, 5 mg gruppen havde et QTcF ≥ 500 msek.
Three (< 1%) out of 409 patients in the degarelix group and four (2%) out of 201 patients in the leuprorelin 7.5 mg group, had a QTcF ≥ 500 msec.
Fra udgangsværdien til slutningen af forsøget var median ændringen i QTcF for degarelix 12, 0 msek., og for leuprorelin var den 16, 7 msek.
From baseline to end of study the median change in QTcF for degarelix was 12.0 msec and for leuprorelin was 16.7 msec.
Andre hormonantagonister og beslægtede stoffer, ATC- kode:
Other hormone antagonists and related agents, ATC code:
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.
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.
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.
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.
Plasmakoncentrationen af dihydrotestosteron (DHT) nedsættes på en lignende måde som testosteron.
The plasma concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone.
Degarelix er effektiv til at nå og vedligeholde testosteron suppression et godt stykke under medicinsk kastrationsniveau på 0, 5 ng/ ml.
Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ ml.
Mediane testosteronniveauer var efter et års behandling på 0, 087 ng/ ml (interkvartile variationsbredde 0, 06- 0, 15), N=167.
Median testosterone levels after one year of treatment were 0.087 ng/ ml (interquartile range 0.06-0.15) N=167.
Effekt og sikkerhed af degarelix blev evalueret i et åbent, multi- center, randomiseret, aktiv komparator kontrolleret, parallel- gruppe forsøg.
Results of the confirmatory Phase III study The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
Forsøget 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.
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.
I alt blev 620 patienter randomiseret i en af de tre behandlingsgrupper, hvoraf 504 (81%) af patienterne fuldførte forsøget.
In total 620 patients were randomised to one of the three treatment groups, of which 504 (81%) patients completed the study.
I degarelix 240/ 80 mg behandlingsgruppen afbrød 41 (20%) patienter forsøget, sammenlignet med 32 (16%) patienter i leuprorelin gruppen.
In the degarelix 240/ 80 mg treatment group 41 (20%) patients discontinued the study, as compared to 32 (16%) patients in the leuprorelin group.
Af de 610 behandlede patienter havde • 31% lokaliseret prostatakræft • 29% regionalt avanceret prostatakræft • 20% metastaserende prostatakræft 6 • 7% en ukendt metastatisk status • 13% tidligere undergået kirurgi med kurativ intension eller strålebehandling og havde en stigende PSA
Of the 610 patients treated • 31% had localised prostate cancer • 29% had locally advanced prostate cancer • 20% had metastatic prostate cancer • 7% had an unknown metastatic status • 13% had previous curative intent surgery or radiation and a rising PSA
Demografien ved start af forsøget var ens mellem armene.
6 Baseline demographics were similar between the arms.
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.
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.
Opnåelse af serumtestosteron (T) ≤0, 5 ng/ ml FIRMAGON er effektiv til at opnå en hurtig testosteron suppression, se tabel 2.
Attainment of serum testosterone (T) ≤ 0.5 ng/ ml FIRMAGON is effective in achieving fast testosterone suppression, see Table 2.
Procent of patienter, der opnåede T≤0, 5 ng/ ml efter start af behandlingen.
Percentage of patients attaining T≤ 0.5 ng/ ml after start of treatment.
Tid Dag 1 Dag 3 Dag 7 Dag 14 Dag 28
Time Day 1 Day 3 Day 7 Day 14 Day 28
Undgåelse af initial stimulation af testosteron Initial stimulation blev defineret ved, at testosteron oversteg udgangsniveauet med ≥15% inden for de første 2 uger.
Avoidance of testosterone surge Surge was defined as testosterone exceeding baseline by ≥ 15% within the first 2 weeks.
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.
None of the degarelix-treated patients experienced a testosterone surge; there was an average decrease of 94% in testosterone at day 3.
Denne forskel var statistisk signifikant (p < 0, 001).
This difference was statistically significant (p < 0.001).
Procentvis ændring i testosteron fra udgangsniveauet ved behandlingsgrupperne indtil dag 28 (median med interkvartile variationsbredder).
Percentage change in testosterone from baseline by treatment group until day 28 (median with interquartile ranges).
Forsøgets primære endemål var testosteron suppressionsværdierne efter et års behandling med degarelix eller leuprorelin.
The primary end-point in the study was testosterone suppression rates after one year of treatment with degarelix or leuprorelin.
Den kliniske fordel for degarelix sammenlignet med leuprorelin plus anti - androgen i den initiale fase af behandlingen er ikke påvist.
The clinical benefit for degarelix compared to leuprorelin plus anti-androgen in the initial phase of treatment has not been demonstrated.
Langtidseffekt Succesfuldt respons i forsøget 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.
7 Long-term effect 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.
Kumulativ sandsynlighed for testosteron ≤0. 5 ng/ ml fra dag 28 til dag 364.
Cumulative probability of testosterone ≤ 0.5 ng/ ml from Day 28 to Day 364.
FIRMAGON 240/ 80 mg N=207
Degarelix 240/ 80 mg N=207
202 97, 2%
202
194 96, 4%
194
(konfidensintervaller) *
Response Rate (confidence intervals)* * Kaplan Meier estimates within group
(93, 5; 98, 8%)
97.2% (93.5; 98.8%)
(92, 5; 98, 2%)
96.4% (92.5; 98.2%)
Nedsættelse af prostata specifik antigen (PSA) 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.
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.
Den mediane PSA i forsøget ved udgangsniveauet var: • 19, 8 ng/ ml for degarelix 240/ 80 mg behandlingsgruppen (interkvartile variationsbredde:
The median PSA in the study at baseline was: • for the degarelix 240/ 80 mg treatment group 19.8 ng/ ml (interquartile range:
P25 9, 4 ng/ ml, P75 46, 4 ng/ ml) • 17, 4 ng/ ml for leuprorelin 7, 5 mg behandlingsgruppen (interkvartile variationsbredde:
P25 9.4 ng/ ml, P75 46.4 ng/ ml) • for the leuprorelin 7.5 mg treatment group 17.4 ng/ ml (interquartile range:
8 Procentvis ændring Procentvis ændring i PSA fra dag 0 til 56
Percentage change in PSA from baseline by treatment group until day 56 (median with interquartile ranges).
Denne forskel var statistisk signifikant (p < 0, 001) for den forudbestemte analyse på dag 14 og dag 28.
This difference was statistically significant (p < 0.001) for the pre-specified analysis at day 14 and day 28.
97%) gennem hele behandlingslængden på et år.
8 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.
I det bekræftende forsøg sammenlignende FIRMAGON med leuprorelin blev der foretaget periodiske elektrokardiogrammer.
In the confirmatory study comparing FIRMAGON to leuprorelin periodic electrocardiograms were performed.
20% af patienterne.
Both therapies showed QT/ QTc intervals exceeding 450 msec in approximately 20% of the patients.
Fra udgangsniveauet til slutningen af forsøget var den mediane ændring for FIRMAGON 12, 0 msek., og for leuprorelin var den 16, 7 msek.
From baseline to end of study the median change for FIRMAGON was 12.0 msec and for leuprorelin it was 16.7 msec.
Udvikling af anti- degarelix antistof blev set hos 10% af patienterne efter behandling med FIRMAGON i et år.
Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for one year.