FrancophonIA/ELRC3.0 huggingface dataset:
English: 1.2 mg/24h transdermal patch
Croatian: 1.2 mg/24h transdermalni flaster
English: 50 mg/dose gel in sachetdose
Croatian: 50 mg/dose gel u vrećici
English: 3, rue du Bourg l´ Abbé FR-75003 Paris
Croatian: 3, rue du Bourg l'Abbé 75003 Paris
English: BESINS INTERNACIONAL 3, Rue du Bourg l'Abbe 75003 Paris
Croatian: Španjolska BESINS INTERNACIONAL 3, Rue du Bourg l'Abbe 75003 Paris
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate UNDESTOR TESTOCAPS 40 mg, capsule moi capsules soft
Croatian: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg kapsule, meke na usta
English: Androgel 25 mg gel in sachet gel in sachet
Croatian: Androgel 25 mg gel in sachet gel u vrećici
English: ProStrakan Limited Galabank Business Park Galashiels, TD1 1QH United Kingdom
Croatian: Mađarska ProStrakan Limited Galabank Business Park Galashiels, TD1 1QH United Kingdom
English: Androtop 50 mg gel v blazinici gel in sachet
Croatian: Androtop 50 mg gel v blazinici gel u vrećici
English: Androtop 25 mg gel v blazinici gel in sachet
Croatian: Androtop 25 mg gel v blazinici gel u vrećici
English: 25 mg/dose gel in sachetdose
Croatian: 25 mg/dose gel u vrećici
English: The Netherlands testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate
Croatian: 5340 BH Oss The Netherlands testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate
English: Denmark ProStrakan Ltd. Galabank Business Park TD1 1QH Galashiels United Kingdom
Croatian: Francuska PROSTRAKAN Ltd Galabank Business Park TD1 1QH Galashiels United Kingdom
English: The reconstitution procedure usually takes a few minutes, but may take up to 15 minutes in some cases.
Croatian: Postupak rekonstitucije obično traje nekoliko minuta, ali u nekim slučajevima može biti potrebno do 15 minuta.
English: Key elements to be included in the educational material
Croatian: Ključni sadržaji koje treba uključiti u edukacijski materijal
English: This medicine is usually injected by a nurse or a doctor.
Croatian: Ovaj lijek obično daje medicinska sestra ili liječnik.
English: A very serious allergic reaction to this medicine is rare.
Croatian: Vrlo ozbiljna alergijska reakcija na ovaj lijek je rijetka.
English: These could be symptoms of a severe allergic reaction.
Croatian: To mogu biti simptomi teške alergijske reakcije.
English: Date of first authorisation: 17/02/2009 Date of latest renewal: 19/09/2013
Croatian: Datum prvog odobrenja: 17/02/2009 Datum posljednje obnove: 19/09/2013
English: Repeat the reconstitution procedure for the second dose.
Croatian: Ponovite postupak rekonstitucije za drugu dozu.
English: Liver function may need to be monitored.
Croatian: Može biti potrebno nadzirati funkciju jetre.
English: Results of the confirmatory Phase III study
Croatian: Rezultati potvrdnog ispitivanja faze III
English: Therefore, all cardiovascular risk factors should be taken into account.
Croatian: Stoga treba uzeti u obzir sve čimbenike rizika za kardiovaskularnu bolest.
English: This difference was statistically significant (p<0.001).
Croatian: Ta je razlika bila statistički značajna (p<0,001).
English: Changes in laboratory parameters
Croatian: Promjene laboratorijskih parametara
English: The distribution volume in healthy elderly men is approximately 1 l/kg.
Croatian: Volumen distribucije u zdravih muškaraca starije dobi približno je 1 l/kg.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste dobili bez recepta.
English: What FIRMAGON is and what it is used for
Croatian: Što je FIRMAGON i za što se koristi
English: Of the 610 patients treated
Croatian: Od 610 liječenih bolesnika bilo ih je
English: Plasma protein binding is estimated to be approximately 90%.
Croatian: Procjenjuje se da je vezanje za proteine plazme približno 90%.
English: DK-2300 Copenhagen S Denmark
Croatian: DK-2300 Copenhagen S Danska
English: Do not give this medicine to children or adolescents.
Croatian: Ne primjenjujte ovaj lijek u djece ili adolescenata.
English: Hence, the procedure described below need to be repeated a second time.
Croatian: Stoga postupak opisan u nastavku treba ponoviti još jedanput.
English: Do not inject directly into a vein.
Croatian: Ne ubrizgavajte izravno u venu.
English: If blood appears in the syringe, the medicinal product can no longer be used.
Croatian: Ako se u štrcaljki pojavi krv, lijek se više ne može upotrijebiti.
English: The median age was 74 years (range 47 to 98 years).
Croatian: Medijan dobi bio je 74 godine (raspon od 47 do 98 godina).
English: • 7% had an unknown metastatic status
Croatian: • 7% s nepoznatim metastatskim statusom
English: Please tell your doctor if you have any of the following:
Croatian: Molimo obavijestite svog liječnika ako imate nešto od sljedećeg:
English: Instructions for proper use NOTE:
Croatian: Upute za pravilnu primjenu NAPOMENA:
English: FIRMAGON is available in 2 pack-sizes.
Croatian: FIRMAGON je dostupan u 2 veličine pakiranja.
English: Long-term effect
Croatian: Dugotrajni učinak
English: Effect on prostate volume
Croatian: Učinak na volumen prostate
English: Therefore, no other dose concentrations than the recommended should be used.
Croatian: Zbog toga se ne smiju primjenjivati druge koncentracije doza osim preporučenih.
English: − Osteoporosis or any condition that affects the strenght of your bones.
Croatian: − osteoporozu ili stanje koje utječe na čvrstoću Vaših kostiju.
English: This is due to the pharmacological effect; and the effect was reversible.
Croatian: To je posljedica farmakološkog učinka, a taj je učinak bio reverzibilan.
English: − excessive sweating (including night sweats), rash
Croatian: − prekomjerno znojenje (uključujući noćna znojenja), osip
English: Other medicines and FIRMAGON
Croatian: Drugi lijekovi i FIRMAGON
English: If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor.
Croatian: Smatrate li da ste zaboravili na svoju mjesečnu dozu lijeka FIRMAGON, molimo obratite se svom liječniku.
English: Due to the risk of microbial contamination, this medicine should be used immediately.
Croatian: Zbog rizika od kontaminacije mikroorganizmima, ovaj lijek treba upotrijebiti odmah.
English: Perform a deep subcutaneous injection.
Croatian: Primijenite duboku supkutanu injekciju.
English: If not used immediately, the use of this medicine are the responsibility of the user.
Croatian: Ako se ne upotrijebi odmah, primjena ovog lijeka odgovornost je korisnika.
English: The first maintenance dose should be given one month after the starting dose.
Croatian: Prvu dozu održavanja potrebno je dati mjesec dana nakon početne doze.
English: Mannitol (E421), water for injections
Croatian: manitol (E421), voda za injekcije
English: These side effects may be due to the treatment or effects resulting from the underlying disease.
Croatian: Te nuspojave mogu biti posljedica liječenja ili učinaka koji su posljedica osnovne bolesti.
English: • Information on the identified and potential risks
Croatian: • podatke o utvrđenim i potencijalnim rizicima.
English: • Information on gel depot formation and possible injections site reactions
Croatian: • informacije o stvaranju gel depoa i moguće reakcije na mjestu primjene injekcije
English: Contents of the pack and other information What FIRMAGON contains
Croatian: Sadržaj pakiranja i druge informacije Što FIRMAGON sadrži
English: Neutropenic fever
Croatian: neutropenijska vrućica
English: Choose a different injection site and inject 3 ml.
Croatian: Izaberite drugo mjesto za primjenu injekcije i ubrizgajte 3 ml.
English: The instructions for reconstitution must be followed carefully.
Croatian: Pažljivo slijedite upute za rekonstituciju.
English: In the event of an overdose the patient should be monitored and appropriate supportive treatment should be given, if considered necessary.
Croatian: U slučaju predoziranja bolesnika je potrebno nadzirati i, u slučaju potrebe, primijeniti odgovarajuće potporno liječenje.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKO
English: Therefore in such patients, the benefit/risk ratio of FIRMAGON must be thoroughly appraised (see sections 4.5 and 4.8).
Croatian: Stoga se u takvih bolesnika mora temeljito procijeniti omjer koristi i rizika pri primjeni lijeka FIRMAGON (vidjeti dijelove 4.5 i 4.8).
English: Preclinical studies on safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential revealed no special hazard for humans.
Croatian: Neklinička ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala nisu pokazala poseban rizik za ljude.
English: Baseline demographics were similar between the arms.
Croatian: Početni demografski podaci bili su slični u sve tri skupine.
English: This medicine is stable for 2 hours at 25ºC.
Croatian: Ovaj lijek je stabilan 2 sata na temperaturi od 25 ºC.
English: The European Medicines Agency has waived the obligation to submit the results of studies with FIRMAGON in all subsets of the paediatric population (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka FIRMAGON u svim podskupinama pedijatrijske populacije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
Croatian: Prekinite postupak i bacite štrcaljku i iglu (za bolesnika rekonstituirajte novu dozu).
English: Intramuscular administration is not recommended as it has not been studied.
Croatian: Intramuskularna primjena se ne preporučuje jer nije ispitana.
English: − If you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6).
Croatian: − ako ste alergični na degareliks ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Maintenance dose - monthly administration
Croatian: Doza održavanja - mjesečna primjena
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Croatian: Nositelj odobrenja (MAH) dogovorit će s nacionalnim nadležnim tijelima detalje edukacijskog programa i uvesti takav program u zemlji kako bi se osiguralo da svi liječnici, prije nego što počnu propisivati lijek, dobiju paket tiskanog materijala namijenjen zdravstvenim djelatnicima koji će uključivati sljedeće:
English: − chills, fever or influenza-like illness after the injection
Croatian: − zimica, vrućica ili bolest slična gripi nakon injekcije
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.
Croatian: U slučaju da se bolesnikov klinički odgovor čini suboptimalan potrebno je potvrditi da su razine testosterona u serumu ostale dovoljno niske.
English: *Known physiological consequence of testosterone suppression
Croatian: *Poznata fiziološka posljedica supresije testosterona
English: In 4 of the 8 cases, the causal relationship between degarelix and the event could not be ruled out; the cases were well documented, without evident alternative aetiology or confounding factors, with compatible time-to-onset and positive dechallenge and increased blood CPK.
Croatian: U 4 od tih 8 slučajeva nije se mogla isključiti uzročno-posljedična veza između degareliksa i događaja; slučajevi su bili dobro dokumentirani, bez vidljive druge etiologije ili zbunjujućih faktora, s usklađenim vremenom do pojave nuspojave i pozitivnim dechallenge i povišenom CPK u krvi.
English: − depression, mental impairment
Croatian: − depresija, mentalno oštećenje
English: FIRMAGON must be reconstituted prior to administration.
Croatian: Prije primjene FIRMAGON se mora rekonstituirati.
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.
Croatian: U zdravih muškaraca, približno 20-30% jednostruke intravenski primijenjene doze izlučuje se mokraćom što upućuje na činjenicu da se 70-80% izluči putem hepatobilijarnog sustava.
English: atrial fibrillation), palpitations, QT prolongation*(see sections 4.4 and 4.5)
Croatian: fibrilaciju atrija), palpitacije, produljenje QT intervala* (vidjeti dijelove 4.4 i 4.5)
English: What FIRMAGON looks like and contents of the pack
Croatian: Kako FIRMAGON izgleda i sadržaj pakiranja
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.
Croatian: Nema naznaka da razvoj protutijela utječe na djelotvornost i sigurnost liječenja lijekom FIRMAGON nakon razdoblja do 5,5 godina liječenja.
English: If you forget to use FIRMAGON
Croatian: Ako ste zaboravili primijeniti FIRMAGON
English: In each case degarelix was discontinued.
Croatian: U svakom od slučajeva prekinuta je primjena degareliksa.
English: The injected liquid forms a gel from which degarelix is released over a period of one month.
Croatian: Ubrizgana tekućina oblikuje gel iz kojega se tijekom mjesec dana oslobađa degareliks.
English: The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
Croatian: Djelotvornost i sigurnost degareliksa procijenjene su u otvorenom, multicentričnom, randomiziranom ispitivanju na usporednim skupinama, kontroliranom aktivnim usporednim lijekom.
English: What you need to know before you use FIRMAGON Do not use FIRMAGON
Croatian: Što morate znati prije nego počnete primjenjivati FIRMAGON
English: In conclusion, rhabdomyolysis should be added to the list of ADRs of the Product Information with a frequency rare.
Croatian: Zaključno, rabdomiolizu treba dodati na popis nuspojava uz učestalost rijetko u informacijama o lijeku.
English: In total 620 patients were randomised to one of the three treatment groups, of which 504 (81%) patients completed the study.
Croatian: Od ukupno 620 bolesnika randomiziranih u jednu od tri skupine liječenja, ispitivanje je završilo njih 504 (81%).
English: Powder Mannitol (E421)
Croatian: Prašak manitol (E421)
English: Degarelix 240/80 mg
Croatian: Degareliks 240/80 mg
English: FIRMAGON contains degarelix.
Croatian: FIRMAGON sadrži degareliks.
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.
Croatian: Degareliks nije supstrat sustava CYP450 u ljudi i nije se pokazalo da in vitro u većoj mjeri inducira ili inhibira CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ili CYP3A4/5.
English: Administration of other concentrations is not recommended because the gel depot formation is influenced by the concentration.
Croatian: Ne preporučuje se primjena drugih koncentracija jer koncentracija utječe na stvaranje gel depoa.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Croatian: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i <1/1000)
English: • 13% had previous curative intent surgery or radiation and a rising PSA
Croatian: • 13% prethodno podvrgnutih kirurškom zahvatu s namjerom izlječenja ili zračenju i s porastom PSA.
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.
Croatian: Za razliku od agonista GnRH-a, antagonisti GnRH-a ne uzrokuju nagli porast LH s posljedičnim porastom testosterona/stimulacijom tumora i potencijalnim razbuktavanjem simptoma nakon početka liječenja.
English: Effect on QT/QTc intervals
Croatian: Učinak na QT/QTc intervale
English: Glucose tolerance
Croatian: Podnošljivost glukoze
English: Do not use this medicine after the expiry date which is stated on the vials, syringes and outer packaging.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočicama, štrcaljkama i vanjskom pakiranju.
English: Testosterone Reversibility
Croatian: Reverzibilnost testosterona
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.
Croatian: U ispitivanju koje je uključivalo bolesnike s rastućim PSA nakon lokalizirane terapije (uglavnom radikalna prostatektomija i zračenje), FIRMAGON je primjenjivan tijekom sedam mjeseci nakon čega je slijedilo sedmomjesečno razdoblje praćenja.
English: − febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart failure
Croatian: − febrilna neutropenija (vrlo nizak broj bijelih krvnih stanica u kombinaciji s vrućicom), srčani udar,
English: It can be anticipated that long periods of testosterone suppression in men will have effects on bone density.
Croatian: Može se pretpostaviti da će duga razdoblja supresije testosterona u muškaraca utjecati na gustoću kostiju.
English: The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels.
Croatian: Terapijski učinak degareliksa potrebno je procjenjivati na temelju kliničkih parametara i serumskih razina prostata specifičnog antigena (PSA).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for degarelix, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za degareliks, znanstveni zaključci CHMP-a su sljedeći:
English: Pharmacotherapeutic group: Endocrine therapy, Other hormone antagonists and related agents, ATC code: L02BX02
Croatian: Farmakoterapijska skupina: lijekovi s djelovanjem na endokrini sustav, drugi antagonisti hormona i srodni lijekovi, ATK oznaka: L02BX02
English: Reduced level of testosterone may cause a reduction in bone calcium (thinning of bones).
Croatian: Smanjena razina testosterona može prouzročiti smanjenje kalcija u kostima (smanjuje se gustoća kostiju).
English: From day 56 to day 364 there were no significant differences between degarelix and the comparator in the percentage change from baseline.
Croatian: Od 56. do 364. dana nije bilo značajnih razlika između degareliksa i usporednog lijeka u postotku promjene od početne vrijednosti.
English: Fertility FIRMAGON may inhibit male fertility as long as the testosterone is suppressed.
Croatian: FIRMAGON može inhibirati plodnost u muškaraca sve dok traje supresija testosterona.
English: The pharmacokinetic behavior of the medicinal product is influenced by its concentration in the solution for injection.
Croatian: Na farmakokinetičko ponašanje lijeka utječe njegova koncentracija u otopini za injekciju.
English: <1/1,000) and very rare (<1/10,000).
Croatian: te vrlo rijetko (<1/10 000).
English: These events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, the incidence of these events pr 100 injections was: 3 for pain and <1 for erythema, swelling, nodule and induration.
Croatian: Ove nuspojave javljale su se uglavnom pri primjeni početne doze, dok je tijekom terapije održavanja uz dozu od 80 mg incidencija tih događaja na 100 injekcija iznosila: 3 za bol a <1 za eritem, oticanje, nodule i otvrdnuće.
English: FIRMAGON must be injected under the skin (subcutaneously) ONLY.
Croatian: FIRMAGON se smije ubrizgati JEDINO pod kožu (supkutano).
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.
Croatian: To učinite tako da uhvatite kožu na trbuhu, podignete potkožno tkivo i duboko uvedete iglu pod kutom ne manjim od 45 stupnjeva.
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.
Croatian: Vrlo su rijetko prijavljene ozbiljne reakcije na mjestu primjene injekcije, kao što su infekcija na mjestu injiciranja, apsces na mjestu injiciranja ili nekroza na mjestu iniciranja koje bi mogle zahtijevati kirurško liječenje/drenažu.
English: If you have diabetes, you may have to measure blood glucose more frequently.
Croatian: Ako imate šećernu bolest, možda ćete morati češće mjeriti šećer u krvi.
English: Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ml.
Croatian: Uspješan odgovor definiran je u ispitivanju kao medikamentna kastracija koja je postignuta 28. dan i održala se do 364. dana, pri čemu nijedna koncentracija testosterona nije bila veća od 0,5 ng/ml.
English: Cmax degarelix plasma concentration decreases in a biphasic fashion, with a mean terminal half-life (t½) of 29 days for the maintenance dose.
Croatian: Cmax plazmatska koncentracija degareliksa smanjuje se bifazično, s prosječnim terminalnim poluvijekom (t½) od 29 dana za dozu održavanja.
English: By doing so, degarelix immediately reduces the level of the male hormone testosterone that stimulates the prostate cancer.
Croatian: Na taj način degareliks odmah smanjuje razine muškog hormona testosterona koji potiče rast raka prostate.
English: The lowest effective maintenance dose of 80 mg degarelix was chosen.
Croatian: Kao najniža učinkovita doza održavanja izabrana je doza od 80 mg degareliksa.
English: There is no clinical experience with the effects of an acute overdose with degarelix.
Croatian: Nema kliničkog iskustva s učincima akutnog predoziranja degareliksom.
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.
Croatian: Srednje najniže vrijednosti bile su otprilike 11-12 ng/ml nakon početne doze i 11-16 ng/ml nakon doze održavanja od 80 mg pri koncentraciji od 20 mg/ml.
English: The serum concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone.
Croatian: Koncentracija dihidrotestosterona (DHT) u serumu smanjuje se na sličan način kao i koncentracija testosterona.
English: FIRMAGON has no or negligible influence on the ability to drive and use machines.
Croatian: FIRMAGON ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i strojevima.
English: Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its effects.
Croatian: Degareliks oponaša prirodni hormon (hormon koji oslobađa gonadotropin, GnRH) i izravno blokira njegove učinke.
English: Median testosterone levels after one year of treatment were 0.087 ng/ml (interquartile range 0.06-0.15) N=167.
Croatian: Medijan razina testosterona nakon jedne godine liječenja iznosio je 0,087 ng/ml (interkvartilni raspon 0,06-0,15) N=167.
English: Powder and solvent for solution for injection Powder: White to off-white powder Solvent: Clear, colourless solution
Croatian: Prašak i otapalo za otopinu za injekciju Prašak: bijeli do bjelkasti prašak Otapalo: bistra, bezbojna otopina
English: Both therapies showed QT/QTc intervals exceeding 450 msec in approximately 20% of the patients.
Croatian: Obje terapije uzrokovale su intervale QT/QTc dulje od 450 ms u približno 20% bolesnika.
English: FIRMAGON must NOT be given into a blood vessel (intravenously).
Croatian: FIRMAGON se NE SMIJE ubrizgati u krvnu žilu (u venu).