natgillin/translations-raw huggingface dataset:
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. 
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.
Baseline demographics were similar between the arms. 
Izhodiščni demografski podatki so bili pri obeh krakih podobni.
The primary end-point in the study was testosterone suppression rates after one year of treatment with degarelix or leuprorelin. 
Primarno končno stanje v študiji je bila pogostnost supresije testosterona po enem letu zdravljenja z degareliksom ali levprorelinom.
The clinical benefit for degarelix compared to leuprorelin plus anti-androgen in the initial phase of treatment has not been demonstrated. 
Klinične koristi degareliksa v primerjavi z levprorelinom plus antiandrogenom v začetni fazi zdravljenja niso dokazali.
Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 97% of patients for at least one year. 
Mesečni vzdrževalni odmerek 80 mg je povzročil dolgotrajno supresijo testosterona pri 97 % bolnikov, ki je trajala vsaj eno leto.
No formal drug-drug interaction studies have been performed. 
Formalnih študij medsebojnega delovanja med zdravili niso izvedli.
The serum concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone. 
Serumska koncentracija dihidrotestosterona (DHT) se zniža na podoben način kot koncentracija testosterona.
By doing so, degarelix immediately reduces the level of the male hormone testosterone that stimulates the prostate cancer. 
Degareliks na ta način takoj zmanjša raven moškega hormona testosterona, ki spodbuja raka prostate.
From day 56 to day 364 there were no significant differences between degarelix and the comparator in the percentage change from baseline. 
Od 56. do 364. dne ni bilo signifikantnih razlik med degareliksom in primerjalnim zdravilom, kar se tiče odstotne spremembe od izhodišča.
For instructions on reconstitution and administration, please see section 6.6. 
Za navodila glede rekonstitucije in uporabe glejte poglavje 6.6.
Effect on prostate volume 
Vpliv na velikost prostate
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. 
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.
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. 
Za razliko od agonistov GnRH antagonisti GnRH ne sprožijo porasta LH s poznejšim porastom testosterona/stimulacijo tumorja in možnim izbruhom simptomov po uvedbi zdravljenja.
− If you have any further questions, ask your doctor. 
− Če imate dodatna vprašanja, se posvetujte z zdravnikom.
Administration of other concentrations is not recommended because the gel depot formation is influenced by the concentration. 
Uporaba drugih koncentracij ni priporočljiva, ker koncentracija vpliva na oblikovanje gelskega depoja.
NOTE: • THE VIALS SHOULD NOT BE SHAKEN 
OPOZORILO: • VIAL NE SMETE STRESATI
* Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. 
* Kemijsko in fizikalno stabilnost v času uporabe so dokazali za 2 uri pri 25 ºC.
Pharmacotherapeutic group: Endocrine therapy, Other hormone antagonists and related agents, ATC code: L02BX02 
Farmakoterapevtska skupina: Zdravila za endokrino zdravljenje, drugi hormonski antagonisti in sorodne učinkovine, oznaka ATC: L02BX02.
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 
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.
Other medicines and FIRMAGON 
Druga zdravila in zdravilo FIRMAGON
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. 
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.
Mild, transient increases in ALT and AST have been seen, these were not accompanied by a rise in bilirubin or clinical symptoms. 
Opazili so blage, prehodne poraste ALT in AST, ki jih niso spremljali niti zvišanje bilirubina niti klinični simptomi.
Development or aggravation of diabetes may occur; therefore diabetic patients may require more frequent monitoring of blood glucose when receiving androgen deprivation therapy. 
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.
including muscle breakdown resulting in kidney damage. 
vključno z razkrojem mišic, kar lahko vodi do poškodbe ledvic.
Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its effects. 
Degareliks posnema naravni hormon (gonadotropin sproščujoči hormon, GnRH) in neposredno blokira njegove učinke.
• 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. 
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.
MedDRA System Organ Class (SOC) 
Organski sistemi po MedDRA (SOC)
Cmax degarelix plasma concentration decreases in a biphasic fashion, with a mean terminal half-life (t½) of 29 days for the maintenance dose. 
Cmax plazemska koncentracija degareliksa se zmanjša na bifazičen način, s srednjim terminalnim razpolovnim časom (t½) 29 dni za vzdrževalni odmerek.
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. 
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.
Attainment of serum testosterone (T) ≤0.5 ng/ml FIRMAGON is effective in achieving fast testosterone suppression, see Table 2. 
Doseganje koncentracije serumskega testosterona (T) ≤0,5 ng/ml Zdravilo FIRMAGON je učinkovito za doseganje hitre supresije testosterona, glejte preglednico 2.
− The other ingredient of the powder is mannitol (E 421). 
− Pomožna snov v prašku je manitol (E 421).
Liver function may need to be monitored. 
Potrebno je spremljati jetrno funkcijo.
Both in vitro and in vivo studies showed no signs of QT prolongation. 
Študije tako in vitro kot in vivo niso pokazale znakov podaljšanja QT.
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če se zdravilo ne uporabi takoj, je za čas shranjevanja in razmere med uporabo odgovoren uporabnik.
Thus, Cmax and bioavailability tend to decrease with increasing dose concentration while the half-life is increased. 
Tako se Cmax in biološka uporabnost z naraščajočo koncentracijo zdravila v odmerku zmanjšujeta, razpolovni čas pa se podaljšuje.
− depression, mental impairment 
− depresija, duševne motnje
Remove the cover from the vial adapter pack. 
Snemite pokrovček z adapterja viale.
Leuprorelin 7.5 mg 
Levprorelin 7,5 mg
The pharmacokinetic behavior of the medicinal product is influenced by its concentration in the solution for injection. 
Na farmakokinetično vedenje zdravila vpliva njegova koncentracija v raztopini za injiciranje.
Instructions for proper use NOTE: 
Navodila za pravilno uporabo zdravila OPOZORILO:
The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels. 
Terapevtski učinek degareliksa moramo spremljati s kliničnimi parametri in serumskimi koncentracijami za prostato specifičnega antigena (PSA).
Surge was defined as testosterone exceeding baseline by ≥15% within the first 2 weeks. 
Porast je bil definiran kot koncentracija testosterona, ki v prvih 2 tednih zdravljenja preseže izhodiščno vrednost za ≥15 %.
Fertility FIRMAGON may inhibit male fertility as long as the testosterone is suppressed. 
Zdravilo FIRMAGON lahko zavira moško plodnost, dokler se vzdržuje supresija testosterona.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. 
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če metoda rekonstitucije izključuje tveganje kontaminacije z mikrobi.
Therefore, clinically significant pharmacokinetic drug-drug interactions in metabolism related to these isoenzymes are unlikely. 
Zato so klinično pomembne farmakokinetične interakcije med zdravili v presnovi, povezane s temi izoencimi, malo verjetne.
Gently pull back the plunger to check if blood is aspirated. 
Previdno povlecite bat navzad, da preverite, ali se aspirira kri.
− chills, fever or influenza-like illness after the injection 
− mrzlica, zvišana telesna temperatura ali gripi podobna bolezen po injekciji
FIRMAGON must be injected under the skin (subcutaneously) ONLY. 
Zdravilo FIRMAGON se sme injicirati SAMO pod kožo (subkutano).
• 13% had previous curative intent surgery or radiation and a rising PSA 
• 13 % predhodno operacijo z namenom zdravljenja ali obsevanje in naraščajoč PSA.
Contents of the pack and other information What FIRMAGON contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo FIRMAGON
Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix. 
Bolnikov z dokazano ali možno boleznijo jeter niso vključevali v dolgoročna klinična preskušanja z degareliksom.
Cardiovascular disease such as stroke and myocardial infarction has been reported in the medical literature in patients with androgen deprivation therapy. 
O srčnožilnih boleznih, kot sta kap in miokardni infarkt, so poročali v medicinski literaturi pri bolnikih, ki se zdravijo z deprivacijo androgenov.
Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. 
Kemijsko in fizikalno stabilnost v času uporabe so dokazali za 2 uri pri 25 ºC.
The lowest effective maintenance dose of 80 mg degarelix was chosen. 
Izbran je bil najmanjši še učinkovit vzdrževalni odmerek degareliksa, 80 mg.
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). 
Dolgi razpolovni čas po subkutanem dajanju zdravila je posledica zelo počasnega sproščanja degareliksa iz depoja, ki nastane na mestu/-ih injiciranja.
The instructions for reconstitution must be followed carefully. 
Skrbno se ravnajte po navodilih za rekonstitucijo.
Median testosterone levels after one year of treatment were 0.087 ng/ml (interquartile range 0.06-0.15) N=167. 
Mediana koncentracija testosterona po enem letu zdravljenja je bila 0,087 ng/ml (interkvartilni razpon 0,06-0,15) n=167.
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. 
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.
With the syringe still attached to the adapter, swirl gently until the liquid looks clear and without undissolved powder or particles. 
Z brizgo, še vedno pritrjeno na adapter, nežno sukajte vialo, dokler ni tekočina na pogled bistra in brez neraztopljenega praška ali delcev.
In conclusion, rhabdomyolysis should be added to the list of ADRs of the Product Information with a frequency rare. 
Rabdomiolizo je potrebno dodati na seznam neželenih učinkov v informacijah o zdravilu, s pogostnostjo redko.
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. 
Nič ne kaže, da bi nastajanje protiteles vplivalo na učinkovitost ali varnost zdravljenja z zdravilom FIRMAGON po zdravljenju, ki traja do 5,5 let.
If the powder adheres to the side of the vial above the liquid surface, the vial can be tilted slightly. 
Če se prašek drži notranje stene viale nad površino tekočine, lahko vialo rahlo nagnete.
Therefore, no other dose concentrations than the recommended should be used. 
Zato se sme v odmerku uporabljati samo priporočena koncentracija zdravila.
Leuprorelin 7.5 mg N=201 
Levprorelin 7,5 mg n=201
Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted (see section 4.4). 
Bolnikov s hudimi okvarami jeter ali ledvic niso proučevali, zato je pri njih potrebna previdnost (glejte poglavje 4.4).
Very common (may affect more than 1 in 10 people) Hot flushes, injection site pain and redness. 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) Vročinski valovi, bolečina in rdečina na mestu injiciranja.
FIRMAGON is available in 2 pack-sizes. 
Zdravilo FIRMAGON je na voljo v dveh velikostih pakiranja.
• 29% had locally advanced prostate cancer 
• 29 % lokalno napredovalega raka prostate,
Hypersensitivity to the active substance or to any of the excipients listed in section 6. 
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.
Since degarelix does not induce a testosterone surge it is not necessary to add an anti-androgen as surge protection at initiation of therapy. 
Ker degareliks ne povzroča porasta testosterona, ob uvedbi zdravljenja ni treba dodajati antiandrogena za zaščito pred porastom.
Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ml. 
Degareliks je učinkovit za dosego in vzdrževanje supresije testosterona precej pod ravnijo medicinske kastracije, ki je 0,5 ng/ml.
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. 
En sam 240-miligramski odmerek degareliksa, ki mu sledi mesečni 80-miligramski vzdrževalni odmerek, hitro povzroči znižanje koncentracij LH, FSH in nato testosterona.
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. 
Degareliks je povzročil od odmerka odvisno podaljšanje časa do parjenja in brejosti, zmanjšano število rumenih telesc (corpora lutea) in zvečano število pred- in postimplantacijskih izgub, splavov, zgodnjih smrti zarodkov/plodov, prezgodnjih kotitev in trajanja poroda.
atrial fibrillation), palpitations, QT prolongation*(see sections 4.4 and 4.5) 
Srčne bolezni srčna aritmija (vključno z atrijsko fibrilacijo), palpitacije, podaljšanje intervala QT* (glejte poglavji 4.4 in 4.5)
How to use FIRMAGON 
Kako uporabljati zdravilo FIRMAGON
Both therapies showed QT/QTc intervals exceeding 450 msec in approximately 20% of the patients. 
Pri obeh zdravilih so intervali QT/QTc pri približno 20 % bolnikov presegali 450 msek.
How to store FIRMAGON Contents of the pack and other information 
Shranjevanje zdravila FIRMAGON Vsebina pakiranja in dodatne informacije
Most of the leuprorelin-treated patients experienced testosterone surge; there was an average increase of 65% in testosterone at day 3. 
Večina bolnikov, zdravljenih z levprorelinom, je dobila porast testosterona; 3. dne se je testosteron povprečno zvišal za 65 %.
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. 
Zelo redko so poročali o resnih reakcijah na mestu injiciranja, kot so okužba na mestu injiciranja, absces na mestu injiciranja ali nekroza na mestu injiciranja, zaradi katerih je lahko potrebno kirurško zdravljenje/drenaža.
• DO NOT SHAKE THE VIALS 
• VIAL NE STRESAJTE
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. 
Koncentracije za prostato specifičnega antigena (PSA) se znižajo za 64 % dva tedna po aplikaciji degareliksa, za 85 % po enem mesecu, za 95 % po treh mesecih, nato pa ostanejo suprimirane (za približno
Neutropenic fever 
nevtropenična vročina
Transfer all solvent to the powder vial. 
Ves vehikel prenesite v vialo s praškom.
Prostatic carcinoma is known to be androgen sensitive and responds to treatment that removes the source of androgen. 
Znano je, da je karcinom prostate občutljiv za androgene in se odziva na zdravljenje, s katerim odstranimo vir androgenov.
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. 
Ti dogodki so se pojavili predvsem pri začetnem odmerku, medtem ko je bila med vzdrževalnim zdravljenjem z 80-miligramskim odmerkom pogostost teh dogodkov na 100 injekcij: bolečina 3, eritem, oteklina, vozlič in zatrdlina pa <1.
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. 
Zniževanje za prostato specifičnega antigena (PSA) Med programom kliničnega preskušanja velikosti tumorja niso merili neposredno, pač pa se je posreden koristni odziv tumorja pri degareliksu po 12 mesecih pokazal s 95-odstotnim znižanjem medianega PSA.
− high blood pressure, changes in heart rhythm, changes in ECG (QT-prolongation), feeling of abnormal heart beat, dyspnoea, peripheral oedema 
− zvišan krvni tlak, spremembe srčnega ritma, spremembe v EKG (podaljšanje intervala QT), občutek nenormalnega utripanja srca, dispneja, periferni edemi
In the degarelix 240/80 mg treatment group 41 (20%) patients discontinued the study, as compared to 32 (16%) patients in the leuprorelin group. 
V skupini, zdravljeni z degareliksom 240/80 mg, je 41 (20 %) bolnikov prekinilo sodelovanje v študiji, v skupini z levprorelinom pa 32 (16 %) bolnikov.
The injection site adverse reactions 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%). 
Neželena učinka na mestu injiciranja, o katerih so poročali, sta bila predvsem bolečina in eritem, o katerih so poročali pri 28 % oziroma 17 % bolnikov, redkeje so poročali o oteklini (6 %), zatrdlini (4 %) in vozliču (3 %).
Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients. 
Degareliks je sintetičen hormonski blokator, ki se uporablja pri zdravljenju raka prostate pri odraslih bolnikih moškega spola.
Animal reproduction studies showed that degarelix caused infertility in male animals. 
Študije razmnoževanja na živalih so pokazale, da degareliks pri samcih povzroča jalovost.
Transient chills, fever or influenza like illness were reported to occur hours after dosing (in 3%, 2% and 1% of patients, respectively). 
Poročali so, da so se prehodna mrzlica, zvišana telesna temperatura ali gripi podobna bolezen pojavljale nekaj ur po prejemu odmerka (pri 3 %, 2 % oziroma 1 % bolnikov).
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). 
Dolgoročno, do 1 leto dolgo zdravljenje z vzdrževalnimi odmerki kaže, da ima 97 % bolnikov trajno suprimirane koncentracije testosterona (T≤0,5 ng/ml).
− unexplained muscular pain or cramps, tenderness, or weakness. 
− nepojasnjene bolečine ali krči v mišicah, občutljivost ali šibkost.
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. 
Zdravila FIRMAGON niso proučevali pri bolnikih z anamnezo korigiranega intervala QT, daljšega od 450 ms; pri bolnikih z anamnezo ali dejavniki tveganja za torsades de pointes; in pri bolnikih, ki sočasno jemljejo zdravila, ki bi lahko podaljšala interval QT.
Degarelix 240/80 mg N=207 
Degareliks 240/80 mg n=207
FIRMAGON contains degarelix. 
Zdravilo FIRMAGON vsebuje degareliks.
FIRMAGON is for subcutaneous use ONLY, not to be administered intravenously. 
Zdravilo FIRMAGON je SAMO za subkutano uporabo, zdravilo ni namenjeno za intravensko uporabo.
FIRMAGON must be reconstituted prior to administration. 
Pred uporabo moramo zdravilo FIRMAGON rekonstituirati.
Avoidance of testosterone surge 
Izogibanje porastu testosterona
Table 2: Percentage of patients attaining T≤0.5 ng/ml after start of treatment. 
Preglednica 2: Odstotek bolnikov, ki so po začetku zdravljenja dosegli T≤0,5 ng/ml.
The effect of degarelix on insulin and glucose levels has not been studied. 
Delovanja degareliksa na koncentracijo insulina in glukoze niso proučevali.
This difference was statistically significant (p<0.001) for the pre-specified analysis at day 14 and day 28. 
Ta razlika je bila za vnaprej določeno analizo 14. dne in 28. dne statistično signifikantna (p<0,001).
The injection site should vary periodically. 
Mesto injiciranja moramo občasno menjavati.
The reconstituted solution should be a clear liquid, free of undissolved matter. 
Rekonstituirana raztopina mora biti bistra tekočina, brez neraztopljenih snovi.
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. 
Degareliks je selektiven antagonist gonadotropin sproščujočega hormona (GnRH), ki se kompetitivno in reverzibilno veže na hipofizne receptorje za GnRH, s čimer hitro zmanjša sproščanje gonadotropinov, luteinizirajočega hormona (LH) in folikle stimulirajočega hormona (FSH), s čimer zmanjša izločanje testosterona (T) iz mod.
Data on patients with severe renal impairment is scarce and caution is therefore warranted in this patient population. 
Podatkov o bolnikih s težko okvaro ledvic je malo, zato je pri tej skupini bolnikov upravičena previdnost.
In the confirmatory study comparing FIRMAGON to leuprorelin periodic electrocardiograms were performed. 
V potrditveni študiji, v kateri so primerjali zdravilo FIRMAGON z levprorelinom, so občasno snemali elektrokardiograme.
The risk of heart rhythm problems may be increased when using FIRMAGON. 
Pri uporabi zdravila FIRMAGON se lahko nevarnost težav s srčnim ritmom zveča.