FrancophonIA/ELRC3.0 huggingface dataset:
English: 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%).
Croatian: Prijavljene nuspojave na mjestu primjene bile su uglavnom bol (u 28% bolesnika) i eritem (17% bolesnika), a manje često su prijavljeni oticanje (6%), otvrdnuće (4%) i noduli (3%).
English: Dose adjustment is not necessary in patients with mild or moderate hepatic impairment.
Croatian: Prilagodba doze nije potrebna u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
English: Attainment of prostate specific antigen (PSA) reduction Tumour size was not measured directly during the clinical trial programme, but there was an indirect beneficial tumour response as shown by a 95% reduction after 12 months in median PSA for degarelix.
Croatian: Veličina tumora nije bila izravno mjerena u okviru programa kliničkog ispitivanja, ali se povoljan odgovor tumora na liječenja degareliksom pokazao neizravno kao 95%-tno smanjenje medijana PSA nakon 12 mjeseci.
English: No testosterone microsurges were observed after re-injection during degarelix treatment.
Croatian: Nisu uočeni nagli manji porasti razine testosterona nakon ponovne injekcije tijekom liječenja degareliksom.
English: 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.
Croatian: Injekcije je potrebno primijeniti u dijelove tijela koji neće biti izloženi pritisku, npr. ne blizu rubova nošenja odjeće oko struka ili mjesta vezanja pojasa i ne blizu rebara.
English: − allergic reactions, hives, itching
Croatian: − alergijske reakcije, urtikarija, svrbež
English: − unexplained muscular pain or cramps, tenderness, or weakness.
Croatian: − neobjašnjiva bol ili grčevi u mišićima, osjetljivost ili slabost mišića.
English: Precautions must be taken to avoid accidental injection into a vein.
Croatian: Osoba koja daje injekciju mora poduzeti potrebne mjere opreza kako bi se izbjegla nehotična injekcija u venu.
English: The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone suppression, including hot flushes and weight increase (reported in 25% and 7%, respectively, of patients receiving treatment for one year), or injection site adverse reactions.
Croatian: Najčešće opažene nuspojave tijekom terapije degareliksom u potvrdnom ispitivanju faze III (N=409) bile su posljedica očekivanih fizioloških učinaka supresije testosterona, uključujući navale vrućine i povećanje težine (zabilježeno u 25% odnosno 7% bolesnika liječenih godinu dana) ili nuspojave na mjestu primjene injekcije.
English: How to use FIRMAGON
Croatian: Kako primjenjivati FIRMAGON
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.
Croatian: Početna doza od 240 mg degareliksa, nakon koje slijedi mjesečna doza održavanja od 80 mg, brzo dovodi do smanjenja koncentracija LH, FSH te posljedično testosterona.
English: − decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar/diabetes mellitus, increased cholesterol, changes in blood calcium, decreased weight
Croatian: − oslabljen apetit, zatvor, povraćanje, suha usta, bol i nelagoda u trbuhu, povišen šećer u krvi/šećerna bolest, povišen kolesterol, promjene razine kalcija u krvi, smanjena tjelesna težina
English: No target organ toxicity was observed from acute, subacute and chronic toxicity studies in rats and monkeys following subcutaneous administration of degarelix.
Croatian: U ispitivanjima akutne, subakutne i kronične toksičnosti u štakora i majmuna nije opažena toksičnost ciljnih organa nakon supkutane primjene degareliksa.
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetko (mogu se pojaviti u do 1 na 1000 osoba)
English: Degarelix is subject to common peptidic degradation during the passage of the hepato-biliary system and is mainly excreted as peptide fragments in the faeces.
Croatian: Degareliks se prilikom prolaska kroz hepatobilijarni sustav razgrađuje kao običan peptid i uglavnom se izlučuje u obliku peptidnih fragmenata u stolici.
English: From baseline to end of study the median change for FIRMAGON was 12.0 msec and for leuprorelin it was 16.7 msec.
Croatian: Od početka do kraja ispitivanja, medijan promjene za FIRMAGON bio je 12,0 ms a za leuprorelin 16,7 ms.
English: Most of the leuprorelin-treated patients experienced testosterone surge; there was an average increase of 65% in testosterone at day 3.
Croatian: Nagli porast testosterona zabilježen je u većine bolesnika liječenih leuprorelinom; 3. dana razina testosterona u prosjeku se povećala za 65%.
English: The effect of degarelix on insulin and glucose levels has not been studied.
Croatian: Nije ispitan učinak degareliksa na razine inzulina i glukoze.
English: FIRMAGON is for subcutaneous use ONLY, not to be administered intravenously.
Croatian: FIRMAGON se primjenjuje SAMO supkutano; ovaj lijek nije namijenjen za intravensku primjenu.
English: Changes in ECG measurements
Croatian: Promjene nalaza EKG-a
English: Avoid shaking to prevent foam formation.
Croatian: Izbjegavajte tresti bočicu da se ne stvara pjena.
English: With the syringe still attached to the adapter, swirl gently until the liquid looks clear and without undissolved powder or particles.
Croatian: Ostavite štrcaljku i dalje pričvršćenu za nastavak bočice i lagano okrećite bočicu sve dok tekućina ne postane bistra i u njoj ne bude neotopljenog praška ili čestica.
English: Only about 20-30% of a given dose of degarelix is excreted unchanged by the kidneys.
Croatian: Od primijenjene doze degareliksa, samo oko 20-30% izlučuje se putem bubrega u nepromijenjenom obliku.
English: Patients with severe hepatic dysfunction have not been studied and caution is therefore warranted in this group.
Croatian: Nisu provedena ispitivanja u bolesnika s teškom disfunkcijom jetre, pa je stoga u toj skupini potreban oprez.
English: Table 3: Cumulative probability of testosterone ≤0.5 ng/ml from Day 28 to Day 364.
Croatian: Tablica 3: Kumulativna vjerojatnost testosterona ≤0,5 ng/ml od 28. do 364. dana Degareliks 240/80 mg
English: FIRMAGON is administered as a subcutaneous injection in the abdominal region.
Croatian: FIRMAGON se primjenjuje kao supkutana injekcija u predjelu trbuha.
English: FIRMAGON is a powder and solvent for solution for injection.
Croatian: FIRMAGON je prašak i otapalo za otopinu za injekciju.
English: None of the degarelix-treated patients experienced a testosterone surge; there was an average decrease of 94% in testosterone at day 3.
Croatian: Niti u jednog bolesnika liječenog degareliksom nije nastupio nagli porast testosterona; 3. dana razina testosterona u prosjeku se smanjila za 94%.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek je potrebno upotrijebiti odmah osim kad metoda rekonstitucije isključuje rizik od kontaminacije mikroorganizmima.
English: Belgique/Belgien Tel/Tél: +32 53 72 92 00 ferringnvsa@ferring.be
Croatian: Belgique/Belgien Tél/Tel: +32 53 72 92 00 ferringnvsa@ferring.be
English: Urticaria, skin nodule, alopecia, pruritus, erythema
Croatian: (uključujući noćna znojenja)*, osip urtikarija, nodul na koži, alopecija, pruritus, eritem
English: Monitoring of liver function in patients with known or suspected hepatic disorder is advised during treatment.
Croatian: U bolesnika s poznatim ili potencijalnim poremećajem funkcije jetre, preporučuje se tijekom liječenja pratiti funkciju jetre.
English: Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 97% of patients for at least one year.
Croatian: U 97% bolesnika mjesečne doze održavanja od 80 mg rezultirale su neprekinutom supresijom testosterona u trajanju od najmanje godinu dana.
English: − The other ingredient of the powder is mannitol (E 421).
Croatian: Drugi je sastojak praška manitol (E421).
English: 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.
Croatian: U medicinskoj literaturi smanjena gustoća kostiju zabilježena je u muškaraca koji su orhidektomirani ili su bili liječeni agonistom GnRH-a.
English: − loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain
Croatian: − gubitak spolne želje, bol u testisima, bol u zdjelici, nemogućnost ejakulacije, genitalna nadraženost, bol u dojkama
English: Effect on QT/QTc interval Long-term androgen deprivation therapy may prolong the QT interval.
Croatian: Dugotrajno liječenje deprivacijom androgena može produljiti QT interval.
English: SC use only
Croatian: Samo s.c. primjena
English: How to store FIRMAGON
Croatian: Kako čuvati FIRMAGON
English: Seek medical advice straight away if you develop a severe rash, itching or shortness of breath or difficulty breathing.
Croatian: U slučaju da se kod Vas pojavi teški osip, svrbež ili da osjetite nedostatak zraka ili teškoće pri disanju, odmah potražite savjet liječnika.
English: Glass (type I) vials with bromobutyl stopper and aluminium flip-off seal containing 120 mg powder for solution for injection
Croatian: Bočica od stakla (tip I) s čepom od bromobutilne gume i aluminijskim „flip-off“ zatvaračem, koja sadrži 120 mg praška za otopinu za injekciju
English: 2 injection needles
Croatian: 2 igle za injekciju
English: FIRMAGON to leuprorelin periodic (monthly) electrocardiograms (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).
Croatian: U potvrdnom ispitivanju u kojemu je FIRMAGON uspoređivan s leuprorelinom, periodički (jednom mjesečno) je sniman elektrokardiogram (EKG); uz obje su terapije QT/QTc intervali bili dulji od 450 ms u približno 20% bolesnika te dulji od 500 ms u 1% bolesnika koji su primali degareliks i 2% bolesnika koji su primali leuprorelin (vidjeti dio 5.1).
English: 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, , moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).
Croatian: Budući da liječenje deprivacijom androgena može produljiti QTc interval, potrebno je pažljivo procijeniti učinak istovremene primjene degareliksa i lijekova za koje se zna da produljuju QTc interval ili onih koji mogu prouzročiti torsades de pointes, kao što su antiaritmici skupine IA (npr. kinidin, dizopiramid) ili skupine III (npr. amiodaron, sotalol, dofetilid, ibutilid), metadon, moksifloksacin, antipsihotici i drugi (vidjeti dio 4.4).
English: Day 14 Day 28
Croatian: 28. dan
English: Cardiac arrhythmia (incl.
Croatian: Srčani poremećaji srčana aritmija (uklj.
English: Use of FIRMAGON has not been investigated in patients with severe kidney disease.
Croatian: Primjena lijeka FIRMAGON nije ispitana u bolesnika s teškom bolešću bubrega.
English: Prepare the pre-filled syringe by attaching the plunger rod.
Croatian: Pripremite napunjenu štrcaljku tako da pričvrstite klip.
English: Anti-degarelix antibodies
Croatian: Protutijela na degareliks
English: Remove the cover from the vial adapter pack.
Croatian: Skinite pokrov s pakiranja nastavka za bočicu.
English: Long term treatment with the maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels (T≤0.5 ng/ml).
Croatian: Dugotrajno liječenje dozom održavanja do 1 godine pokazuje neprekinutu supresiju razina testosterona (T≤0,5 ng/ml) u 97% bolesnika.
English: Hyperglycemia/Diabetes mellitus, cholesterol increased, weight decreased, appetite decreased, changes in blood calcium
Croatian: Poremećaji metabolizma i prehrane povećanje težine* hiperglikemija/dijabetes melitus, povišen kolesterol, smanjena težina, oslabljen apetit, promjene razine kalcija u krvi
English: including muscle breakdown resulting in kidney damage.
Croatian: Problemi s mišićima mogu biti ozbiljni, uključujući razgradnju mišićnog tkiva koja ima za posljedicu oštećenje bubrega.
English: Bilirubin increased, alkaline phosphatase increased
Croatian: Poremećaji jetre i žuči povišene jetrene transaminaze povišen bilirubin, povišena alkalna fosfataza
English: Gynaecomastia*, testicular atrophy*, erectile dysfunction*
Croatian: Poremećaji reproduktivnog sustava i dojki ginekomastija*, testikularna atrofija, erektilna disfunkcija*
English: Use of FIRMAGON has not been investigated in patients with severe hypersensitivity reactions.
Croatian: Primjena lijeka FIRMAGON nije ispitana u bolesnika s teškim reakcijama preosjetljivosti.
English: − skin redness, loss of hair, skin nodule, numbness
Croatian: − crvenilo kože, gubitak kose, čvorići u koži, utrnulost
English: FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g. methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics).
Croatian: FIRMAGON može ometati djelovanje nekih lijekova za liječenje tegoba sa srčanim ritmom (npr. kinidin, prokainamid, amiodaron i sotalol) ili drugih lijekova koji mogu utjecati na srčani ritam (npr. metadon (koristi se za ublažavanje bolova te kao dio detoksikacije, tj. čišćenja organizma kod ovisnosti o drogama), moksifloksacin (antibiotik), antipsihotici).
English: • for the leuprorelin 7.5 mg treatment group 17.4 ng/ml (interquartile range: P25 8.4 ng/ml, P75
Croatian: • 17,4 ng/ml za skupinu liječenu leuprorelinom 7,5 mg (interkvartilni raspon: P25 8,4 ng/ml, P75 56,5 ng/ml)
English: Surge was defined as testosterone exceeding baseline by ≥15% within the first 2 weeks.
Croatian: Nagli porast bio je definiran kao razina testosterona koja je u prva 2 tjedna premašila početnu vrijednost za
English: Pregnancy and breast-feeding There is no relevant indication for use of FIRMAGON in women.
Croatian: Nema odgovarajuće indikacije za primjenu lijeka FIRMAGON u žena.
English: This difference was statistically significant (p<0.001) for the pre-specified analysis at day 14 and day 28.
Croatian: Za unaprijed određenu analizu 14. i 28. dana, ta je razlika bila statistički značajna (p<0,001).
English: For instructions on reconstitution and administration, please see section 6.6.
Croatian: Za upute o rekonstituciji i primjeni molimo vidjeti dio
English: Degarelix has been investigated in a pharmacokinetic study in patients with mild to moderate hepatic impairment.
Croatian: Degareliks je ispitivan u farmakokinetičkom ispitivanju u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: How to store FIRMAGON Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije
English: Figure 1: Percentage change in testosterone from baseline by treatment group until day 28 (median with interquartile ranges).
Croatian: Slika 1: Postotak promjene koncentracije testosterona od početne koncentracije do 28. dana (medijan s interkvartilnim rasponima) po skupini liječenja
English: Hypertension, vasovagal reaction (incl.
Croatian: hipertenzija, vazovagalna reakcija (uklj. hipotenziju)
English: Marked decrease in haematological values, hematocrit (≤0.37) and hemoglobin (≤115 g/l) were seen in 40% and 13-15%,
Croatian: Nakon liječenja s oba lijeka primijećeno je izrazito smanjenje hematoloških parametara; hematokrita (≤0,37) u 40% i hemoglobina (≤115 g/l) u 13-15%
English: Turn the vial upside down and draw up to the line mark on the syringe for injection.
Croatian: Okrenite bočicu naopako i iz nje izvucite količinu do oznake na štrcaljki za injekciju.
English: − muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint
Croatian: − mišićna slabost, grčevi mišića, oticanje/ukočenost zglobova, osteoporoza/osteopenija, bol u zglobovima
English: Injection needles (25G 0.5 x 25 mm)
Croatian: Igla za injekciju (25G 0,5 x 25 mm) Veličine pakiranja
English: Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 4 ml containing 4.2 ml solvent
Croatian: Napunjena štrcaljka od stakla (tip I) s čepom klipa od elastomera, zatvaračem vrha i oznakom za 4 ml, koja sadrži 4,2 ml otapala
English: Response Rate (confidence intervals)* * Kaplan Meier estimates within group
Croatian: Broj bolesnika s odgovorom 202 Stopa odgovora (intervali pouzdanosti)* *Procjene unutar skupine prema Kaplan Meieru Ostvareno smanjenje prostata specifičnog antigena (PSA)
English: − The active substance is degarelix.
Croatian: Djelatna tvar je degareliks.
English: The primary objective was to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to below 0.5 ng/ml, during 12 months of treatment.
Croatian: Primarni cilj bio je dokazati da je tijekom liječenja od 12 mjeseci degareliks učinkovit s obzirom na postizanje supresije testosterona i održavanje njegove razine ispod 0,5 ng/ml.
English: − frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at night, impaired renal function, incontinence
Croatian: − učestalo mokrenje, urgentno mokrenje (neodgodiva potreba za mokrenjem), teškoće s mokrenjem ili bolno mokrenje, noćno mokrenje, oštećena bubrežna funkcija, nemogućnost zadržavanja mokraće
English: Tel: +386 1 5899 179 regulatory@salus.si
Croatian: SALUS, Veletrgovina, d.o.o. Tel: +386 1 5899 179 regulatory@salus.si
English: − discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction)
Croatian: − nelagoda u trenutku primjene injekcije uključujući sniženje krvnog tlaka i brzine otkucaja srca
English: Changes in bone density
Croatian: Promjene gustoće kostiju
English: 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. From baseline to end of study the median change in QTcF for degarelix was 12.0 msec and for leuprorelin was 16.7 msec.
Croatian: Tri (<1%) bolesnika od ukupno 409 u skupini koja je primala degareliks i četiri bolesnika (2%) od ukupno 201 u skupini koja je primala leuprorelin 7,5 mg, imali su QTcF ≥ 500 ms.
English: Tabulated list of adverse reactions The frequency of undesirable effects listed below is defined using the following convention:
Croatian: Učestalost nuspojava navedenih u nastavku definirana je na sljedeći način:
English: Renal impairment Degarelix has not been studied in patients with severe renal impairment and caution is therefore warranted.
Croatian: Degareliks nije ispitivan u bolesnika s teškim oštećenjem funkcije bubrega pa je stoga potreban oprez.
English: Common (may affect up to 1 in 10 people)
Croatian: Često (mogu se pojaviti u do 1 na 10 osoba)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE FOR SOLVENT 4.2 ml water for injections
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA ZA OTAPALO 4,2 ml voda za injekcije
English: The pack contains one vial of powder and one pre-filled syringe with solvent that must be prepared for subcutaneous injection.
Croatian: Pakiranje sadrži jednu bočicu s praškom i jednu štrcaljku napunjenu otapalom za pripremu supkutane injekcije.
English: Attach the adapter to the powder vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snaps in place.
Croatian: Nastavak pričvrstite na bočicu s praškom tako da ga gurate prema dolje sve dok šiljak ne probije gumeni čep bočice i nastavak se ne uglavi na mjestu.
English: Pre-filled glass (type I) syringes with elastomer plunger stopper, tip cap and line-marking at 3 ml containing 3 ml solvent
Croatian: Napunjena štrcaljka od stakla (tip I) s čepom klipa od elastomera, zatvaračem vrha i oznakom za 3 ml, koja sadrži 3 ml otapala Klipovi štrcaljke
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE FOR SOLVENT 3 ml water for injections
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA ZA OTAPALO 3 ml voda za injekcije
English: Testicular pain, breast pain, pelvic pain, genital irritation, ejaculation failure
Croatian: bol u testisima, bol u dojkama, bol u zdjelici, genitalna iritacija,
English: Changes in ECG measurements seen during one year of treatment in the confirmatory phase III study (N=409) were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator.
Croatian: U potvrdnom ispitivanju faze III (N=409), promjene u EKG-u utvrđene tijekom liječenja u trajanju od jedne godine kretale su se u istom rasponu i za degareliks i za agonist GnRH-a (leuprorelin) kao usporedni lijek.
English: Figure 2: Percentage change in PSA from baseline by treatment group until day 56 (median with interquartile ranges).
Croatian: Slika 2: Postotak promjene vrijednosti PSA od početne vrijednosti do 56. dana (medijan s interkvartilnim rasponima) po skupini liječenja.
English: Transient chills, fever or influenza like illness were reported to occur hours after dosing (in 3%, 2% and 1% of patients, respectively).
Croatian: Zabilježena je pojava prolazne zimice (u 3% bolesnika), vrućice (u 2%) ili bolesti nalik gripi (u 1% bolesnika) nekoliko sati nakon primjene doze.
English: Pack-size of 3 trays containing: 3 powder vials, 3 solvent pre-filled syringes, 3 plunger rods, 3 vial adapters and 3 needles.
Croatian: pakiranje od 3 podloška koje sadrži: 3 bočice s praškom, 3 štrcaljke napunjene otapalom, 3 klipa za štrcaljku, 3 nastavka za bočicu i 3 igle.
English: Data on patients with severe renal impairment is scarce and caution is therefore warranted in this patient population.
Croatian: Zbog nedostatnih podataka o primjeni u bolesnika s teškim oštećenjem funkcije bubrega, u toj je populaciji bolesnika potreban oprez.
English: • At the request of the European Medicines Agency
Croatian: Nadalje, nadopunjeni RMP treba dostaviti: • Na zahtjev Europske agencije za lijekove
English: Detach the syringe from the vial adapter and attach the needle for deep subcutaneous injection to the syringe.
Croatian: Odvojite štrcaljku od nastavka na bočici i na štrcaljku pričvrstite iglu za duboku supkutanu injekciju.
English: 1 plunger rod, 1 vial adapter and 1 injection needle.
Croatian: 1 klip štrcaljke, 1 nastavak za bočicu i 1 iglu za injekciju.
English: Pack-size of 2 trays containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles
Croatian: Pakiranje od 2 podloška koje sadrži 2 bočice s praškom, 2 štrcaljke napunjene otapalom, 2 klipa za štrcaljku, 2 nastavka za bočicu i 2 igle.
English: Busuttil Ltd. Tel: +356 21447184 info@ejbusuttil.com
Croatian: Tel: +356 21447184 info@ejbusuttil.com
English: infusion of degarelix over 60 min, reaching a mean Cmax of 222 ng/mL, approx. 3-4fold the Cmax obtained during prostate cancer treatment.
Croatian: intervala na zdravim ispitanicima (N=80) koji su primili i.v. infuziju degareliksa tijekom 60 minuta i dosegli srednju vrijednost Cmax od 222 ng/ml, što je približno 3 do 4 puta više od vrijednosti Cmax postignute tijekom liječenja karcinoma prostate.
English: − Diabetes mellitus.
Croatian: − šećernu bolest.