natgillin/translations-raw huggingface dataset:
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.
No injections should be given in areas where the patient will be exposed to pressure, e.g. around the belt or waistband or close to the ribs.
Injekcij ne smete dajati v predele, ki so izpostavljeni pritisku, na primer v bližini pasu ali reber.
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.
Najpogosteje opaženi neželeni učinki med zdravljenjem z degareliksom v potrditveni študiji faze III (n=409) so bili posledica pričakovanih fizioloških učinkov supresije testosterona, med drugim vročinskih valov in zvečanja telesne mase (o teh učinkih so poročali pri 25 % oziroma 7 % bolnikov, ki so prejemali zdravilo eno leto), ali o neželenih učinkih na mestu injiciranja.
• 20% had metastatic prostate cancer
• 20 % raka prostate z metastazami,
Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ml to prostate cancer patients in the pivotal study CS21, AUC0-28 days was 635 (602-668) day*ng/ml, Cmax was 66.0 (61.071.0) ng/ml and occurred at tmax at 40 (37-42) hours.
Po subkutani aplikaciji 240 mg degareliksa v koncentraciji 40 mg/ml bolnikom z rakom prostate v ključni študiji CS21 je bila AUC0-28 dni 635 (602-668) dan*ng/ml, Cmax je bila 66,0 (61,0-71,0) ng/ml, nastopila pa je ob tmax 40 (37-42) ur.
− discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction)
− nelagodje ob injekciji, vključno z znižanim krvnim tlakom in srčno frekvenco (vazovagalna reakcija) − splošno slabo počutje.
EU/1/08/504/001 Pack-size of 1 tray EU/1/08/504/003 Pack-size of 3 trays
EU/1/08/504/001 Pakiranje z 1 podstavkom EU/1/08/504/003 Pakiranje s 3 podstavki
Table 1: Frequency of adverse drug reactions reported in 1,259 patients treated for a total of 1781 patient years (phase II and III studies) and from post-marketing reports
Preglednica 1: Pogostnost neželenih učinkov, o katerih so poročali pri 1.259 bolnikih, zdravljenih skupaj 1781 bolniških let (študije faze II in III) in v poročilih v odbobju trženja zdravila.
The pharmacokinetics of degarelix has been investigated after single intravenous administration in subjects with mild to moderate hepatic impairment (see section 5.2).
Farmakokinetiko degareliksa so raziskali po enkratnem intravenskem odmerku pri osebah z blago do zmerno okvaro jeter (glejte poglavje 5.2).
Figure 1: Percentage change in testosterone from baseline by treatment group until day 28 (median with interquartile ranges).
Slika 1: Odstotna sprememba testosterona od izhodišča po zdravljenih skupinah do 28. dne (mediana z interkvartilnimi razponi).
FIRMAGON is available in 2 pack-sizes:
Zdravilo FIRMAGON je na voljo v 2 velikostih pakiranja:
None of the degarelix-treated patients experienced a testosterone surge; there was an average decrease of 94% in testosterone at day 3.
Nobeden od bolnikov, zdravljenih z degareliksom, ni imel porasta testosterona; 3. dne se je testosteron znižal povprečno za 94 %.
• 31% had localised prostate cancer
• 31 % lokaliziranega raka prostate,
− The solvent is water for injections.
− Vehikel je voda za injekcije.
Myocardial infarction, cardiac failure
miokardni infarkt, srčno popuščanje
240 mg administered as two consecutive subcutaneous injections of 120 mg each
240 mg, danih v obliki dveh zaporednih 120-miligramskih subkutanih injekcij
There is no need to adjust the dose for the elderly or in patients with mild or moderate liver or kidney function impairment (see section 5.2).
Pri starejših bolnikih ali pri bolnikih z blago do zmerno zmanjšanim delovanjem jeter ali ledvic prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
The recommended starting dose is two consecutive injections of 120 mg. After that, you will receive a monthly 80 mg injection.
Priporočeni začetni odmerek je 2 zaporedni injekciji po 120 mg. Nato boste prejemali po eno 80-miligramsko injekcijo na mesec.
Effect on QT/QTc interval Long-term androgen deprivation therapy may prolong the QT interval.
Dolgoročno zdravljenje z deprivacijo androgenov lahko podaljša interval QT.
Injection needles (25G 0.5 x 25 mm)
Injekcijska igla (25G 0,5 x 25 mm)
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema anemija*
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.
Degareliks se pri prehodu skozi hepatobiliarni sistem razgradi kot vsak peptid in se v blatu izloča večinoma v obliki peptidnih fragmentov.
Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the starting dose with 96% of the patients having serum testosterone levels corresponding to medical castration (T≤0.5 ng/ml) after three days and 100% after one month.
Klinične študije so pokazale, da takoj po aplikaciji začetnega odmerka nastopi supresija testosterona (T), tako da ima čez tri dni 96 % bolnikov, čez en mesec pa 100 % bolnikov serumske koncentracije testosterona (T≤0,5 ng/ml), ki ustrezajo medicinski kastraciji.
A thorough QT study showed that there was no intrinsic effect of degarelix on QT/QTc interval (see section
Temeljita študija intervala QT je pokazala, da degareliks ni imel intrinzičnih učinkov na interval QT/QTc (glejte poglavje 4.8).
There is no clinical experience with the effects of an acute overdose with degarelix.
Z učinki akutnega prevelikega odmerka degareliksa ni na voljo nikakršnih kliničnih izkušenj.
If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor.
Če menite, da so pozabili na vašo vsakomesečno injekcijo zdravila FIRMAGON, to povejte zdravniku.
Use of FIRMAGON has not been investigated in patients with severe kidney disease.
Uporaba zdravila FIRMAGON ni bila raziskana pri bolnikih s hudo boleznijo ledvic.
The median time to testosterone recovery (>0.5 ng/mL, above castrate level) after discontinuation of treatment was 112 days (counted from start of monitoring period, i.e 28 days after last injection).
Mediani čas do vrnitve na raven testosterona > 0,5 ng/mL (nad mejo za medicinsko kastracijo) je bil po prenehanju zdravljenja 112 dni (šteto od začetka obdobja opazovanja, t.j.
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.
V medicinski literaturi so poročali o zmanjšanju kostne gostote pri moških, ki so imeli orhiektomijo ali so jih zdravili s kakim agonistom GnRH.
FIRMAGON has no or negligible influence on the ability to drive and use machines.
Zdravilo FIRMAGON nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
80 mg administered as one subcutaneous injection
80 mg, danih v obliki ene subkutane injekcije
Use of FIRMAGON has not been investigated in patients with severe hypersensitivity reactions.
Uporaba zdravila FIRMAGON ni bila raziskana pri bolnikih s hudimi preobčutljivostnimi reakcijami.
Always make sure to withdraw the precise volume and adjust for any air bubbles.
Vedno se prepričajte, da ste povlekli iz viale pravilno količino in jo prilagodite, če so v njej zračni mehurčki.
Insomnia Depression, libido decreased*
Psihiatrične motnje nespečnost depresija, zmanjšanje libida*
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).
FIRMAGON za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2. )
Markedly abnormal (>3*ULN) liver transaminase values (ALT, AST and GGT) were seen in 2-6% of patients with normal values prior to treatment, following treatment with both medicinal products.
Znatno nenormalne (>3*ULN) vrednosti jetrnih transaminaz (ALT, AST in GGT) so našli po zdravljenju z obema zdraviloma pri 2-6 % bolnikov, ki so imeli pred zdravljenjem normalne vrednosti.
The study investigated the efficacy and safety of two different degarelix monthly dosing regimens with a starting dose of 240 mg (40 mg/ml) followed by monthly doses subcutaneous administration of 160 mg (40 mg/ml) or 80 mg (20 mg/ml), in comparison to monthly intramuscular administration of 7.5 mg leuprorelin in patients with prostate cancer requiring androgen deprivation therapy.
V študiji so raziskovali učinkovitost in varnost dveh različnih shem mesečnega odmerjanja degareliksa z začetnim odmerkom 240 mg (40 mg/ml), ki so mu sledili subkutano dani vsakomesečni odmerki po 160 mg (40 mg/ml) ali 80 mg (20 mg/ml), v primerjavi z vsakomesečnim intramuskularnim dajanjem levprorelina v odmerku 7,5 mg pri bolnikih z rakom prostate,
Table 3: Cumulative probability of testosterone ≤0.5 ng/ml from Day 28 to Day 364.
Preglednica 3: Kumulativna verjetnost, da bo koncentracija testosterona od 28. do 364. dne ≤0,5 ng/ml.
Markedly abnormal values of potassium (≥5.8 mmol/l), creatinine (≥177 μmol/l) and BUN (≥10.7 mmol/l) in patients with normal values prior to treatment, were seen in 6%, 2% and 15% of degarelix treated patients and 3%, 2% and 14% of leuprorelin treated patients, respectively.
Znatno nenormalne vrednosti kalija (≥5,8 mmol/l), kreatinina (≥177 μmol/l) oziroma dušika iz plazemske sečnine (≥10,7 mmol/l) pri bolnikih, ki so imeli pred zdravljenjem normalne vrednosti, so ugotovili pri 6 %, 2 % oziroma 15 % bolnikov, zdravljenih z degareliksom, in pri 3 %, 2 % oziroma 14 % bolnikov, zdravljenih z levprorelinom.
Injection needle (25G 0.5 x 25 mm)
Injekcijski igli (25G 0,5 x 25 mm)
Degarelix has not been studied in patients with a history of severe untreated asthma, anaphylactic reactions or severe urticaria or angioedema.
Pri bolnikih z anamnezo težke nezdravljene astme, anafilaktičnih reakcij ali težke urtikarije ali angioedema degareliksa niso proučevali.
The clearance of degarelix when administered as single intravenous doses (0.864-49.4 µg/kg) in healthy elderly men was found to be 3550 ml/h/kg.
Ugotovili so, da je očistek degareliksa, danega zdravim starejšim moškim v obliki posameznih intravenskih odmerkov (0,864-49,4 µg/kg), 35-50 ml/h/kg.
2 injection needles
2 injekcijski igli
Patients with severe hepatic dysfunction have not been studied and caution is therefore warranted in this group.
Bolnikov s težko disfunkcijo jeter niso proučevali, zato je pri tej skupini upravičena previdnost.
What FIRMAGON looks like and contents of the pack
Izgled zdravila FIRMAGON in vsebina pakiranja
Only about 20-30% of a given dose of degarelix is excreted unchanged by the kidneys.
Ledvici izločita v nespremenjeni obliki le okrog 20-30 % danega odmerka degareliksa.
Changes in laboratory values 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.
Spremembe laboratorijskih vrednosti, ki so jih ugotovili med enoletnim zdravljenjem v potrditveni študiji faze III (n=409), so bile za degareliks in agonist GnRH (levprorelin), ki so ga uporabili kot primerjalno zdravilo, v istih mejah.
Taking into account the PRAC Assessment Report on the PSUR(s) for degarelix, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za degareliks je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Solvent for FIRMAGON Water for injections
vehikel za zdravilo FIRMAGON voda za injekcije
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.
Pritrdite adapter na vialo s praškom, tako da adapter pritiskate navzdol, dokler konica ne prodre skozi gumijasti zamašek in adapter ne tleskne na svoje mesto.
Detach the syringe from the vial adapter and attach the needle for deep subcutaneous injection to the syringe.
Snemite brizgo z adapterja viale in nataknite na brizgo iglo za globoko subkutano injiciranje.
− Severe hypersensitivity.
− resno preobčutljivost.
Attach the syringe to the powder vial by screwing it on to the adapter.
Pritrdite brizgo na vialo s praškom, tako da jo privijete na adapter.
Degarelix has been investigated in a pharmacokinetic study in patients with mild to moderate hepatic impairment.
Degareliks so raziskovali v farmakokinetični študiji pri bolnikih z blago do zmerno okvaro jeter.
Figure 2: Percentage change in PSA from baseline by treatment group until day 56 (median with interquartile ranges).
Slika 2: Odstotna sprememba PSA od izhodišča po zdravljenih skupinah do 56. dne (mediana z interkvartilnimi razponi).
Changes in bone density
Spremembe kostne gostote
FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
Zdravilo FIRMAGON je antagonist gonadotropin sproščujočega hormona (GnRH), indiciran za zdravljenje odraslih bolnikov moškega spola z napredovalim hormonsko odvisnim rakom prostate.
− decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar/diabetes mellitus, increased cholesterol, changes in blood calcium, decreased weight
− zmanjšan tek, zaprtje, bruhanje, suha usta, bolečine in nelagodje v trebuhu, zvišan krvni sladkor/sladkorna bolezen, zvišan holesterol, spremembe kalcija v krvi, zmanjšana telesna masa
− increased weight, nausea, diarrhoea, elevated levels of some liver enzymes
− zvečana telesna masa, navzea, driska, zvišana raven nekaterih jetrnih encimov
No significant metabolites were detected in plasma samples after subcutaneous administration.
V vzorcih plazme niso po subkutani aplikaciji odkrili nikakršnih pomembnejših presnovkov.
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.
Elektrokardiografske spremembe, ki so jih ugotovili med enim letom zdravljenja v potrditveni študiji faze III (n=409), so bile za degareliks in agonist GnRH (levprorelin), ki so ga uporabili kot primerjalno zdravilo, v istih mejah.
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.
Primarni namen je bil dokazati, da je degareliks med enoletnim zdravljenjem učinkovit za doseganje in vzdrževanje supresije testosterona pod 0,5 ng/ml.
Pollakiuria, micturition urgency, dysuria, nocturia, renal impairment, incontinence
Bolezni sečil polakisurija, urgentne mikcije, dizurija, nokturija, okvare ledvic, inkontinenca
There is no relevant use of FIRMAGON in children and adolescents in the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Zdravilo FIRMAGON ni primerno za uporabo pri otrocih in mladostnikih, ker je indicirano za zdravljenje odraslih bolnikov moškega spola z napredovalim hormonsko odvisnim rakom prostate .
Pack-size of 3 trays containing:
Pakiranje s 3 podstavki vsebuje:
Day 1 Day 3
3. dan
Pack-size of 2 trays containing:
Pakiranje z 2 podstavkoma vsebuje:
Rare (may affect up to 1 in 1,000 people)
Redki (pojavijo se največ pri 1 od 1.000 bolnikov)
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).
(EKG-je); pri obeh zdravilih so ugotovili intervale QT/QTc, ki so presegli 450 msek pri približno 20 % bolnikov, pri 1 % na degareliksu oziroma 2 % bolnikov na levprorelinu pa 500 msek (glejte poglavje 5.1).
− The active substance is degarelix.
− Zdravilna učinkovina je degareliks.
Cardiovascular disease
Srčnožilne bolezni
Precautions must be taken to avoid accidental injection into a vein.
Oseba, ki injicira zdravilo, mora paziti, da zdravila ne bi pomotoma injicirala v veno.
In female reproduction toxicity studies degarelix revealed findings expected from the pharmacological properties.
Študije toksičnosti za razmnoževanje pri samicah so pokazale ugotovitve, kakršne pričakujemo zaradi farmakoloških lastnosti zdravila.
Tiredness and dizziness are common side effects that may impair your ability to drive and use machines.
Utrujenost in omotica sta pogosta neželena učinka, ki vam lahko zmanjšata sposobnost upravljanja vozil in strojev.
• for the degarelix 240/80 mg treatment group 19.8 ng/ml (interquartile range: P25 9.4 ng/ml, P75
• pri skupini, zdravljeni z degareliksom v odmerkih 240/80 mg, 19,8 ng/ml (interkvartilni razpon: P25 9,4 ng/ml, P75 46,4 ng/ml);
The median time to testosterone >1.5 ng/mL (above lower limit of normal range) was 168 days.
28 dni po zadnjem injiciranju), mediani čas do ravni testosterona > 1,5 ng/mL (nad spodnjo mejo normale) je bil 168 dni.
No. of responders
Število responderjev
Each vial contains 120 mg degarelix (as acetate).
Ena viala vsebuje 120 mg degareliksa (v obliki acetata).
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.
To naredite tako, da s palcem in kazalcem primete kožo na trebuhu, dvignete podkožno tkivo in iglo globoko zabodete pod kotom vsaj 45 stopinj.
It is unknown to what extent this decrease in haematological values was caused by the underlying prostate cancer and to what extent it was a consequence of androgen deprivation therapy.
Ni znano, do kakšne mere je to zmanjšanje hematoloških vrednosti povzročila osnovna bolezen, t.j.