FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Therefore in such patients, the benefit/risk ratio of FIRMAGON must be thoroughly appraised (see sections 4.5 and 4.8).
Slovenian: Zato moramo pri takih bolnikih temeljito oceniti razmerje med koristjo in tveganjem, povezanim z uporabo zdravila FIRMAGON (glejte poglavji 4.5 in 4.8).
English: Choose a different injection site and inject 3 ml.
Slovenian: Izberite drugo mesto injiciranja in injicirajte 3 ml.
English: In vitro studies have shown that degarelix is not a substrate for the human CYP450 system.
Slovenian: Študije in vitro so pokazale, da degareliks ni substrat za humani sistem CYP450.
English: Intramuscular administration is not recommended as it has not been studied.
Slovenian: Intramuskularna uporaba ni priporočljiva, ker je niso raziskovali.
English: Mannitol (E421), water for injections
Slovenian: Manitol (E421), voda za injekcije.
English: If you have diabetes, you may have to measure blood glucose more frequently.
Slovenian: Če imate sladkorno bolezen, si boste mogoče morali pogosteje meriti glukozo v krvi.
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.
Slovenian: Pri zdravih moških se približno 20-30 % posameznega intravensko danega odmerka izloči v urinu, kar kaže, da se 70-80 % zdravila izloča skozi hepatobiliarni sistem.
English: Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
Slovenian: Prekinite postopek in zavrzite brizgo in iglo (za bolnika rekonstituirajte nov odmerek).
English: If not used immediately, the use of this medicine are the responsibility of the user.
Slovenian: Če se zdravilo ne uporabi takoj, je za uporabo tega zdravila odgovoren uporabnik.
English: What you need to know before you use FIRMAGON Do not use FIRMAGON
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo FIRMAGON Ne uporabljajte zdravila FIRMAGON
English: What FIRMAGON is and what it is used for What you need to know before you use FIRMAGON How to use FIRMAGON
Slovenian: Kaj je zdravilo FIRMAGON in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo FIRMAGON Kako uporabljati zdravilo FIRMAGON
English: If you forget to use FIRMAGON
Slovenian: Če ste pozabili uporabiti zdravilo FIRMAGON
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.
Slovenian: Če se bolnikov klinični odziv zdi suboptimalen, moramo preveriti, ali serumske koncentracije testosterona ostajajo dovolj suprimirane.
English: Date of first authorisation: 17/02/2009 Date of latest renewal: 19/09/2013
Slovenian: Datum pridobitve dovoljenja za promet: 17/02/2009 Datum zadnjega podaljšanja dovoljenja za promet: 19/09/2013
English: Reduced level of testosterone may cause a reduction in bone calcium (thinning of bones).
Slovenian: Znižan nivo testosterona lahko povzroči znižanje kalcija v kosteh (tanjšanje kosti).
English: Preclinical studies on safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential revealed no special hazard for humans.
Slovenian: Predklinične študije varnostne farmakologije, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala niso pokazale posebnega tveganja za človeka.
English: What FIRMAGON is and what it is used for
Slovenian: Kaj je zdravilo FIRMAGON in za kaj ga uporabljamo
English: • Educational material
Slovenian: • izobraževalno gradivo,
English: Do not use this medicine after the expiry date which is stated on the vials, syringes and outer packaging.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali, injekcijski brizgi in zunanji ovojnini.
English: It can be anticipated that long periods of testosterone suppression in men will have effects on bone density.
Slovenian: Lahko predvidevamo, da bodo dolgotrajna obdobja testosteronske supresije pri moških vplivala na kostno gostoto.
English: Glucose tolerance
Slovenian: Toleranca za glukozo
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Slovenian: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do
English: • 7% had an unknown metastatic status
Slovenian: • 7 % neznano stanje glede metastaz,
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Slovenian: • povzetek glavnih značilnosti zdravila (SPC), navodilo za uporabo in označevanje.
English: − febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart failure
Slovenian: − febrilna nevtropenija (zelo nizko število belih krvnih celic v kombinaciji z vročino), srčni napad, srčno popuščanje.
English: The injected liquid forms a gel from which degarelix is released over a period of one month.
Slovenian: Iz vbrizgane tekočine nastane gel, iz katerega se degareliks sprosti v obdobju enega meseca.
English: The median PSA in the study at baseline was:
Slovenian: Mediani PSA v študiji ob izhodišču je bil:
English: Effect on QT/QTc intervals
Slovenian: Vpliv na interval QT/QTc
English: Side effects at the injection site are most common with the starting dose and less common with the maintenance dose.
Slovenian: Neželeni učinki na mestu injiciranja so najbolj pogosti pri začetnem odmerku in manj pogosti pri vzdrževalnem odmerku.
English: − If you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6).
Slovenian: − če ste alergični na degareliks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
Slovenian: Učinkovitost in varnost degareliksa so ovrednotili v odprti, multicentrični, randomizirani študiji s paralelnimi skupinami, kontrolirani z aktivnim primerjalnim zdravilom.
English: FIRMAGON must NOT be given into a blood vessel (intravenously).
Slovenian: Zdravilo FIRMAGON se NE sme dati v krvno žilo (intravensko).
English: *Known physiological consequence of testosterone suppression
Slovenian: *znana fiziološka posledica supresije testosterona
English: Powder Mannitol (E421)
Slovenian: Prašek manitol (E421)
English: The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (<1%).
Slovenian: Dogodki, o katerih so poročali, so bili večinoma prehodni, blago do zmerno izraženi in so povzročili zelo malo prekinitev zdravljenja (<1 %).
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.
Slovenian: Degareliks ni substrat humanega sistema CYP450 in zanj niso dokazali, da bi in vitro v večjem obsegu induciral ali inhibiral CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A4/5.
English: Baseline demographics were similar between the arms.
Slovenian: Izhodiščni demografski podatki so bili pri obeh krakih podobni.
English: The primary end-point in the study was testosterone suppression rates after one year of treatment with degarelix or leuprorelin.
Slovenian: Primarno končno stanje v študiji je bila pogostnost supresije testosterona po enem letu zdravljenja z degareliksom ali levprorelinom.
English: The clinical benefit for degarelix compared to leuprorelin plus anti-androgen in the initial phase of treatment has not been demonstrated.
Slovenian: Klinične koristi degareliksa v primerjavi z levprorelinom plus antiandrogenom v začetni fazi zdravljenja niso dokazali.
English: Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 97% of patients for at least one year.
Slovenian: Mesečni vzdrževalni odmerek 80 mg je povzročil dolgotrajno supresijo testosterona pri 97 % bolnikov, ki je trajala vsaj eno leto.
English: No formal drug-drug interaction studies have been performed.
Slovenian: Formalnih študij medsebojnega delovanja med zdravili niso izvedli.
English: The serum concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone.
Slovenian: Serumska koncentracija dihidrotestosterona (DHT) se zniža na podoben način kot koncentracija testosterona.
English: By doing so, degarelix immediately reduces the level of the male hormone testosterone that stimulates the prostate cancer.
Slovenian: Degareliks na ta način takoj zmanjša raven moškega hormona testosterona, ki spodbuja raka prostate.
English: From day 56 to day 364 there were no significant differences between degarelix and the comparator in the percentage change from baseline.
Slovenian: Od 56. do 364. dne ni bilo signifikantnih razlik med degareliksom in primerjalnim zdravilom, kar se tiče odstotne spremembe od izhodišča.
English: For instructions on reconstitution and administration, please see section 6.6.
Slovenian: Za navodila glede rekonstitucije in uporabe glejte poglavje 6.6.
English: Effect on prostate volume
Slovenian: Vpliv na velikost prostate
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.
Slovenian: Populacijska farmakokinetična analiza podatkov iz potrditvene študije faze III je pokazala, da se očistek degareliksa pri bolnikih z blago do zmerno okvaro ledvic zmanjša za približno 23 %; zato prilagajanja odmerka pri bolnikih z blago do zmerno okvaro ledvic ne priporočajo.
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.
Slovenian: Za razliko od agonistov GnRH antagonisti GnRH ne sprožijo porasta LH s poznejšim porastom testosterona/stimulacijo tumorja in možnim izbruhom simptomov po uvedbi zdravljenja.
English: − If you have any further questions, ask your doctor.
Slovenian: − Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: Administration of other concentrations is not recommended because the gel depot formation is influenced by the concentration.
Slovenian: Uporaba drugih koncentracij ni priporočljiva, ker koncentracija vpliva na oblikovanje gelskega depoja.
English: NOTE: • THE VIALS SHOULD NOT BE SHAKEN
Slovenian: OPOZORILO: • VIAL NE SMETE STRESATI
English: * Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Slovenian: * Kemijsko in fizikalno stabilnost v času uporabe so dokazali za 2 uri pri 25 ºC.
English: Pharmacotherapeutic group: Endocrine therapy, Other hormone antagonists and related agents, ATC code: L02BX02
Slovenian: Farmakoterapevtska skupina: Zdravila za endokrino zdravljenje, drugi hormonski antagonisti in sorodne učinkovine, oznaka ATC: L02BX02.
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
Slovenian: Na podlagi znanstvenih zaključkov za degareliks odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) degareliks nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Other medicines and FIRMAGON
Slovenian: Druga zdravila in zdravilo FIRMAGON
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.
Slovenian: Razvoj protiteles proti degareliksu so ugotovili pri 10 % bolnikov po enoletnem zdravljenju z zdravilom FIRMAGON in pri 29 % bolnikov, ki so bili zdravljeni z zdravilom FIRMAGON do 5,5 let.
English: Mild, transient increases in ALT and AST have been seen, these were not accompanied by a rise in bilirubin or clinical symptoms.
Slovenian: Opazili so blage, prehodne poraste ALT in AST, ki jih niso spremljali niti zvišanje bilirubina niti klinični simptomi.
English: Development or aggravation of diabetes may occur; therefore diabetic patients may require more frequent monitoring of blood glucose when receiving androgen deprivation therapy.
Slovenian: Lahko se razvije ali poslabša sladkorna bolezen; zato je pri bolnikih z diabetesom, ki se zdravijo z deprivacijo androgenov, lahko potrebno pogostejše spremljanje krvne glukoze.
English: including muscle breakdown resulting in kidney damage.
Slovenian: vključno z razkrojem mišic, kar lahko vodi do poškodbe ledvic.
English: Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its effects.
Slovenian: Degareliks posnema naravni hormon (gonadotropin sproščujoči hormon, GnRH) in neposredno blokira njegove učinke.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
English: MedDRA System Organ Class (SOC)
Slovenian: Organski sistemi po MedDRA (SOC)
English: Cmax degarelix plasma concentration decreases in a biphasic fashion, with a mean terminal half-life (t½) of 29 days for the maintenance dose.
Slovenian: Cmax plazemska koncentracija degareliksa se zmanjša na bifazičen način, s srednjim terminalnim razpolovnim časom (t½) 29 dni za vzdrževalni odmerek.
English: Degarelix 240/80 mg
Slovenian: Degareliks 240/80 mg
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.
Slovenian: V študiji, ki je vključevala bolnike z naraščajočim PSA po lokalnem zdravljenju (predvsem radikalni prostatektomiji in obsevanju), so bolniki sedem mesecev prejemali zdravilo FIRMAGON, nato pa je sledilo sedemmesečno obdobje opazovanja.
English: Attainment of serum testosterone (T) ≤0.5 ng/ml FIRMAGON is effective in achieving fast testosterone suppression, see Table 2.
Slovenian: Doseganje koncentracije serumskega testosterona (T) ≤0,5 ng/ml Zdravilo FIRMAGON je učinkovito za doseganje hitre supresije testosterona, glejte preglednico 2.
English: − The other ingredient of the powder is mannitol (E 421).
Slovenian: − Pomožna snov v prašku je manitol (E 421).
English: Liver function may need to be monitored.
Slovenian: Potrebno je spremljati jetrno funkcijo.
English: Both in vitro and in vivo studies showed no signs of QT prolongation.
Slovenian: Študije tako in vitro kot in vivo niso pokazale znakov podaljšanja QT.
English: Testosterone Reversibility
Slovenian: Reverzibilnost testosterona
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če se zdravilo ne uporabi takoj, je za čas shranjevanja in razmere med uporabo odgovoren uporabnik.
English: Thus, Cmax and bioavailability tend to decrease with increasing dose concentration while the half-life is increased.
Slovenian: Tako se Cmax in biološka uporabnost z naraščajočo koncentracijo zdravila v odmerku zmanjšujeta, razpolovni čas pa se podaljšuje.
English: − depression, mental impairment
Slovenian: − depresija, duševne motnje
English: Remove the cover from the vial adapter pack.
Slovenian: Snemite pokrovček z adapterja viale.
English: Leuprorelin 7.5 mg
Slovenian: Levprorelin 7,5 mg
English: The pharmacokinetic behavior of the medicinal product is influenced by its concentration in the solution for injection.
Slovenian: Na farmakokinetično vedenje zdravila vpliva njegova koncentracija v raztopini za injiciranje.
English: Instructions for proper use NOTE:
Slovenian: Navodila za pravilno uporabo zdravila OPOZORILO:
English: The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels.
Slovenian: Terapevtski učinek degareliksa moramo spremljati s kliničnimi parametri in serumskimi koncentracijami za prostato specifičnega antigena (PSA).
English: Degarelix
Slovenian: Degareliks
English: Surge was defined as testosterone exceeding baseline by ≥15% within the first 2 weeks.
Slovenian: Porast je bil definiran kot koncentracija testosterona, ki v prvih 2 tednih zdravljenja preseže izhodiščno vrednost za ≥15 %.
English: Fertility FIRMAGON may inhibit male fertility as long as the testosterone is suppressed.
Slovenian: Zdravilo FIRMAGON lahko zavira moško plodnost, dokler se vzdržuje supresija testosterona.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če metoda rekonstitucije izključuje tveganje kontaminacije z mikrobi.
English: Therefore, clinically significant pharmacokinetic drug-drug interactions in metabolism related to these isoenzymes are unlikely.
Slovenian: Zato so klinično pomembne farmakokinetične interakcije med zdravili v presnovi, povezane s temi izoencimi, malo verjetne.
English: Gently pull back the plunger to check if blood is aspirated.
Slovenian: Previdno povlecite bat navzad, da preverite, ali se aspirira kri.
English: − chills, fever or influenza-like illness after the injection
Slovenian: − mrzlica, zvišana telesna temperatura ali gripi podobna bolezen po injekciji
English: FIRMAGON must be injected under the skin (subcutaneously) ONLY.
Slovenian: Zdravilo FIRMAGON se sme injicirati SAMO pod kožo (subkutano).
English: • 13% had previous curative intent surgery or radiation and a rising PSA
Slovenian: • 13 % predhodno operacijo z namenom zdravljenja ali obsevanje in naraščajoč PSA.
English: Contents of the pack and other information What FIRMAGON contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo FIRMAGON
English: Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix.
Slovenian: Bolnikov z dokazano ali možno boleznijo jeter niso vključevali v dolgoročna klinična preskušanja z degareliksom.
English: Cardiovascular disease such as stroke and myocardial infarction has been reported in the medical literature in patients with androgen deprivation therapy.
Slovenian: O srčnožilnih boleznih, kot sta kap in miokardni infarkt, so poročali v medicinski literaturi pri bolnikih, ki se zdravijo z deprivacijo androgenov.
English: Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Slovenian: Kemijsko in fizikalno stabilnost v času uporabe so dokazali za 2 uri pri 25 ºC.
English: The lowest effective maintenance dose of 80 mg degarelix was chosen.
Slovenian: Izbran je bil najmanjši še učinkovit vzdrževalni odmerek degareliksa, 80 mg.
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).
Slovenian: Dolgi razpolovni čas po subkutanem dajanju zdravila je posledica zelo počasnega sproščanja degareliksa iz depoja, ki nastane na mestu/-ih injiciranja.
English: The instructions for reconstitution must be followed carefully.
Slovenian: Skrbno se ravnajte po navodilih za rekonstitucijo.
English: Median testosterone levels after one year of treatment were 0.087 ng/ml (interquartile range 0.06-0.15) N=167.
Slovenian: Mediana koncentracija testosterona po enem letu zdravljenja je bila 0,087 ng/ml (interkvartilni razpon 0,06-0,15) n=167.
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.
Slovenian: Srednje najnižje vrednosti so bile približno 11-12 ng/ml po začetnem odmerku in 1116 ng/ml po vzdrževalnem odmerjanju 80 mg v koncentraciji 20 mg/ml.
English: With the syringe still attached to the adapter, swirl gently until the liquid looks clear and without undissolved powder or particles.
Slovenian: Z brizgo, še vedno pritrjeno na adapter, nežno sukajte vialo, dokler ni tekočina na pogled bistra in brez neraztopljenega praška ali delcev.
English: In conclusion, rhabdomyolysis should be added to the list of ADRs of the Product Information with a frequency rare.
Slovenian: Rabdomiolizo je potrebno dodati na seznam neželenih učinkov v informacijah o zdravilu, s pogostnostjo redko.
English: There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation after up to 5.5 years of treatment.
Slovenian: Nič ne kaže, da bi nastajanje protiteles vplivalo na učinkovitost ali varnost zdravljenja z zdravilom FIRMAGON po zdravljenju, ki traja do 5,5 let.
English: If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly.
Slovenian: Če se prašek drži notranje stene viale nad površino tekočine, lahko vialo rahlo nagnete.
English: Therefore, no other dose concentrations than the recommended should be used.
Slovenian: Zato se sme v odmerku uporabljati samo priporočena koncentracija zdravila.
English: Leuprorelin 7.5 mg N=201
Slovenian: Levprorelin 7,5 mg n=201
English: Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted (see section 4.4).
Slovenian: Bolnikov s hudimi okvarami jeter ali ledvic niso proučevali, zato je pri njih potrebna previdnost (glejte poglavje 4.4).
English: Very common (may affect more than 1 in 10 people) Hot flushes, injection site pain and redness.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) Vročinski valovi, bolečina in rdečina na mestu injiciranja.
English: FIRMAGON is available in 2 pack-sizes.
Slovenian: Zdravilo FIRMAGON je na voljo v dveh velikostih pakiranja.
English: • 29% had locally advanced prostate cancer
Slovenian: • 29 % lokalno napredovalega raka prostate,
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.
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.
Slovenian: Ker degareliks ne povzroča porasta testosterona, ob uvedbi zdravljenja ni treba dodajati antiandrogena za zaščito pred porastom.
English: Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ml.
Slovenian: Degareliks je učinkovit za dosego in vzdrževanje supresije testosterona precej pod ravnijo medicinske kastracije, ki je 0,5 ng/ml.
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.
Slovenian: En sam 240-miligramski odmerek degareliksa, ki mu sledi mesečni 80-miligramski vzdrževalni odmerek, hitro povzroči znižanje koncentracij LH, FSH in nato testosterona.