natgillin/translations-raw huggingface dataset:
The recommended dose of Firazyr is one injection (3 ml, 30 mg) applied subcutaneously (under the skin) as soon as you notice the attack of hereditary angioedema becoming moderately or severely worse (for example increased skin swelling, particularly affecting the face and neck, or increasing tummy pain).
Priporočeni odmerek zdravila Firazyr je ena injekcija (3 ml, 30 mg), dana subkutano (pod kožo), kakor hitro opazite, da se napad hereditarnega (prirojenega) angioedema zmerno ali močno poslabša (na primer povečano otekanje kože, zlasti na obrazu in vratu, ali močnejše bolečine v trebuhu).
If you experience no relief of symptoms after 6 hours, an additional injection of Firazyr (3 ml) can be given.
Če po 6 urah ne občutite olajšanja simptomov, se lahko da dodatna injekcija zdravila Firazyr (3 ml).
If after a further 6 hours you still experience no relief you might have a third injection Firazyr (3 ml).
Če po nadaljnjih 6 urah še vedno ne občutite olajšanja, bo morda potrebna tretja injekcija zdravila Firazyr (3 ml).
You should not have more than 3 injections in a 24 hour period and no more than 8 injections of Firazyr in total per month.
V 24- urnem obdobju smete prejeti največ 3 injekcije, v enem mesecu pa največ 8 injekcij zdravila Firazyr.
Like all medicines, Firazyr can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Firazyr neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Almost all patients receiving Firazyr will experience a reaction at the site of the injection.
Skoraj vsi bolniki, ki prejemajo zdravilo Firazyr, občutijo reakcijo na mestu injiciranja.
The reaction may include burning sensations, reddening of the skin (erythema), pain, swelling, feeling of warmth and itching (pruritus).
Reakcija lahko vključuje pekoč občutek, pordečitev kože (eritem), bolečino, oteklino, občutek toplote in srbečico (pruritus).
These effects are usually mild and clear up by themselves without the need for any additional treatment.
Ti učinki so navadno blagi in izginejo sami brez dodatnega zdravljenja.
20 The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10), common (affects 1 to 10 users in 100), uncommon (affects 1 to 10 users in 1,000), rare (affects 1 to 10 users in 10,000), very rare (affects less than 1 user in 10,000), not known (frequency cannot be estimated from the available data).
20 Pogostnost spodaj naštetih možnih neželenih učinkov je opredeljena sledeče: zelo pogosti (prizadenejo več kot enega bolnika izmed 10), pogosti (prizadenejo 1 do 10 izmed 100 bolnikov), občasni (prizadenejo 1 do 10 izmed 1000 bolnikov), redki (prizadenejo 1 do 10 izmed 10. 000 bolnikov), zelo redki (prizadenejo manj kot enega bolnika izmed 10. 000), neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Asthma Bruising Cough Fever Hot flushes Increased amount of uric acid in the blood (indicator of gout) Itching Sore throat Positive test for protein in your urine Vomiting Tiredness Weight gain
Zelo pogosti: reakcije na mestu injiciranja (pekoč občutek, pordečitev kože, bolečina, oteklina, občutek toplote in srbečica) Pogosti: neobičajni izvidi nekaterih krvnih preiskav zamašen nos glavobol omotica šibkost mišic navzea (slabost) bolečina v trebuhu izpuščaji, pordelost kože Občasni astma podplutba kašelj povišana telesna temperatura navali vročine povečana količina sečne kisline v krvi (pokazatelj protina) srbečica bolečine v grlu pozitivni test proteinov v seču bruhanje utrujenost povečanje telesne mase
Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received Firazyr.
Nemudoma obvestite svojega zdravnika, če opazite, da so se simptomi napada po uporabi zdravila Firazyr poslabšali.
HOW TO STORE FIRAZYR
SHRANJEVANJE ZDRAVILA FIRAZYR
Do not use Firazyr after the expiry date stated on the label.
Zdravila Firazyr ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
The expiry date refers to the last day of the month stated on the label.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Firazyr should not be used if the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.
Zdravila Firazyr ne smete uporabljati, če je ovojnina brizge ali igle poškodovana ali če so vidni znaki kvarjenja, na primer, če je raztopina motna, če v njej plavajo delci ali če se je spremenila barva raztopine.
What Firazyr contains
Kaj vsebuje zdravilo Firazyr
- The active substance is icatibant 30 milligrams (as acetate) in 3 ml solution for injection in each
- Zdravila učinkovina je ikatibant 30 miligramov (v obliki acetata) v 3 ml raztopine za injiciranje
pre-filled syringe.
v posamezni napolnjeni injekcijski brizgi.
- The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for
- Pomožne snovi so natrijev klorid, koncentrirana ocetna kislina, natrijev hidroksid in voda za
injection.
injekcije.
The solution does not contain any preservative.
Raztopina ne vsebuje konzervansov.
Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe (3 ml).
Zdravilo Firazyr je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski stekleni brizgi (3 ml).
130 10115 Berlin Germany.
130 10115 Berlin Nemčija.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI NAJ JIH IZPOLNIJO ALI UVELJAVIJO DRŽAVE ČLANICE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI NAJ JIH IZPOLNIJO ALI UVELJAVIJO DRŽAVE ČLANICE
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: • Educational material • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Imetnik dovoljenja za promet z zdravilom (MAH) se mora z nacionalnimi pristojnimi organi dogovoriti o podrobnostih izobraževalnega programa in mora ta program uvesti nacionalno, s čimer bo zagotovil, da bodo pred začetkom predpisovanja vsi zdravniki prejeli paket z zdravstvenimi profesionalnimi informacijami, ki bo vseboval: • izobraževalni material, • povzetek glavnih značilnosti zdravila (SPC) in navodilo za uporabo in označevanje.
• Posology • Instructions for administration • Information on gel depot formation and possible injections site reactions • Information on the identified and potential risks.
• odmerjanje, • navodila za uporabo, • informacije o oblikovanju gelskega depoja in možnih reakcijah na mestu injiciranja, • informacije o znanih in možnih nevarnostih.
This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen. ‘ Advanced ’ means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs.
Izraz „ napredovali “ pomeni, da se je rak iz žleze razširil na nekatere bezgavke, ne pa tudi na druge organe.
Firmagon can be used if the cancer is ‘ hormone-dependent’, which means that it responds to treatments that reduce the levels of the hormone testosterone.
Zdravilo Firmagon se lahko uporablja, če je rak „ hormonsko odvisen “, kar pomeni, da se odziva na zdravljenja, ki zmanjšajo koncentracijo hormona testosterona.
Treatment starts with two 120-mg injections, followed by single 80-mg injections every month.
Zdravljenje se začne z dvema 120- miligramskima injekcijama, ki jima sledi ena 80- miligramska injekcija vsak mesec.
During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level.
Med prvim letom je imelo 97% bolnikov, ki so prejemali zdravilo Firmagon pri odobrenem odmerku 80 mg enkrat mesečno, nižjo koncentracijo testosterona od zahtevane.
This was compared with 96% of patients receiving leuprorelin.
Pri bolnikih, ki so prejemali levprorelin, je bila ta vrednost 96%.
However, because the main study looked at the medicine ’ s effects on testosterone levels rather than the cancer or the patient’ s outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer.
Ker pa so v glavni študiji raziskovali učinke zdravila na koncentracijo testosterona in ne neposredno na raka ali izid za bolnika ter ker se levprorelin uporablja samo za napredovalega raka prostate, se je Odbor odločil omejiti uporabo zdravila Firmagon na napredovalega raka prostate.
The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘ GnRH agonists’ (other medicines for prostate cancer that stimulate the production of GnRH).
Odbor je prav tako ugotovil, da zdravljenje z zdravilom Firmagon ne sproži začasnega hitrega dviga koncentracije testosterona, ki je značilna za „ agoniste gonadotropin sproščujočega hormona “ (druga zdravila za raka prostate, ki spodbujajo tvorjenje gonadotropin sproščujočega hormona).
Therefore, the CHMP decided that Firmagon’ s benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Zaradi tega je CHMP zaključil, da so koristi zdravila Firmagon pri zdravljenju odraslih moških bolnikov z napredovalim rakom prostate, ki je odvisen od hormonov, večje od z njim povezanih tveganj.
The materials will include information on Firmagon’ s safety and remind doctors how to administer the medicine.
Ta gradiva bodo vključevala informacije o varnosti zdravila Firmagon in zdravnike opominjala na pravilen način dajanja zdravila.
The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/ S on 17 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Firmagon, veljavno po vsej Evropski uniji, odobrila družbi Ferring Pharmaceuticals A/ S dne 17. februarja 2009.
EU/ 1/ 08/ 504/ 001
Številka EU EU/ 1/ 08/ 504/ 001
FIRMAGON
Izmišljeno ime FIRMAGON
80 mg
jakost 80 mg
Powder and solvent for solution for injection
farmacevtska oblika prašek in vehikel za raztopino za injiciranje
Subcutaneous use
pot uporabe subkutana uporaba
Powder: vial (glass) Solvent: vial (glass)
ovojnina prašek: viala (steklo) vehikel: viala (steklo)
1 vial +1 vial +1 syringe +2 needles
velikost pakiranja 1 viala + 1 viala + 1 brizga + 2 igli
2 vials+2 vials+ 2 syringes +4 needles
2 viali + 2 viali + 2 brizgi + 4 igle
Powder and solvent for solution for injection (Powder for injection and solvent)
Prašek in vehikel za raztopino za injiciranje (prašek za injekcijo in vehikel).
Powder:
Prašek: bel do belkast prašek.
White to off-white powder Solvent:
Vehikel: bistra, brezbarvna raztopina.
FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
FIRMAGON je antagonist gonadotropin sproščujočega hormona (GnRH), indiciran za zdravljenje odraslih bolnikov moškega spola z napredovalim hormonsko odvisnim rakom prostate.
240 mg administered as two subcutaneous injections of 120 mg each
240 mg, danih v obliki dveh 120- miligramskih subkutanih injekcij
The first maintenance dose should be given one month after the starting dose.
Prvi vzdrževalni odmerek moramo dati en mesec po
Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the starting dose with 96% of the patients having plasma 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 plazemske koncentracije testosterona (T≤0, 5 ng/ ml), ki ustrezajo medicinski kastraciji.
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).
Method of administration FIRMAGON must be reconstituted prior to administration.
Način uporabe Pred uporabo moramo zdravilo FIRMAGON rekonstituirati.
For instructions on reconstitution and administration, please see section 6.6.
Za navodila za rekonstitucijo in uporabo glejte poglavje 6. 6.
2 Intramuscular administration is not recommended as it has not been studied.
2 SAMO za subkutano uporabo, zdravilo ni namenjeno za intravensko uporabo.
As with other medicinal products administered by subcutaneous injection, the injection site should vary periodically.
Tako kot pri drugih zdravilih, ki se dajejo s subkutano injekcijo, moramo mesto injiciranja občasno menjavati.
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.
Injekcij ne smete dajati v predele, ki so izpostavljeni pritisku, na primer v bližini pasu ali reber.
Special patient populations Elderly, hepatically or renally impaired patients:
Posebne skupine bolnikov Starejši bolniki, bolniki z okvarami jeter ali ledvic:
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).
Patients with severe liver or kidney impairment have not been studied and caution is therefore warranted (see section 4.4).
Bolnikov s težkimi okvarami jeter ali ledvic niso proučevali, zato je pri njih potrebna previdnost (glejte poglavje 4. 4).
There is no relevant indication for use of FIRMAGON in women, children and adolescents.
Ustreznih indikacij za uporabo zdravila FIRMAGON pri ženskah, otrocih in mladostnikih ni.
The data available on efficacy and safety experience with degarelix is limited to a one year treatment.
Podatki o izkušnjah glede učinkovitosti in varnosti degareliksa, ki so na voljo, so omejeni na enoletno zdravljenje.
Effect on QT/ QTc interval Long-term androgen deprivation therapy may prolong the QT interval.
Vpliv na interval QT/ QTc Dolgoročno zdravljenje z deprivacijo androgenov lahko podaljša interval QT.
In the confirmatory study comparing FIRMAGON to leuprorelin periodic (monthly) 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).
V potrditveni študiji, v kateri so primerjali zdravilo FIRMAGON z levprorelinom, so snemali periodične EKG- je (enkrat na mesec); 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).
Therefore in such patients, the benefit/ risk ratio of FIRMAGON must be thoroughly appraised (see sections 4.5 and 4.8).
Zato moramo pri takih bolnikih temeljito oceniti razmerje med koristjo in tveganjem, povezanim z uporabo zdravila FIRMAGON (glejte poglavji 4. 5 in 4. 8).
Hepatic impairment Patients with known or suspected hepatic disorder have not been included in long-term clinical trials with degarelix.
Okvara jeter Bolnikov z dokazano ali možno boleznijo jeter niso vključevali v dolgoročna klinična preskušanja z degareliksom.
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).
Renal impairment Degarelix has not been studied in patients with severe renal impairment and caution is therefore warranted.
Okvara ledvic Pri bolnikih s težkimi okvarami ledvic degareliksa niso proučevali, zato je potrebna previdnost.
Hypersensitivity Degarelix has not been studied in patients with a history of severe untreated asthma, anaphylactic reactions or severe urticaria or angioedema.
Preobčutljivost Pri bolnikih z anamnezo težke nezdravljene astme, anafilaktičnih reakcij ali težke urtikarije ali angioedema degareliksa niso proučevali.
Changes in bone density 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.
Spremembe kostne gostote V medicinski literaturi so poročali o zmanjšanju kostne gostote pri moških, ki so imeli orhiektomijo ali so jih zdravili s kakim agonistom GnRH.
3 A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
3 Toleranca za glukozo Pri moških, ki so imeli orhiektomijo ali so jih zdravili s kakim agonistom GnRH, so opazili zmanjšano toleranco za glukozo.
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, cisapride, moxifloxacine, antipsychotics, etc. should be carefully evaluated (see section 4.4).
(glejte poglavje 4. 4).
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.
No studies on the effects of degarelix on the ability to drive and use machines have been performed.
Študij o vplivu degareliksa na sposobnost vožnje in upravljanja s stroji niso izvedli.
However, fatigue and dizziness are common adverse reactions that might influence the ability to drive and use machines.
Pogosti neželeni reakciji, ki bi lahko vplivali na sposobnost vožnje in upravljanja s stroji, pa sta utrujenost in vrtoglavost.
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 events.
Najpogosteje opažene neželene reakcije med zdravljenjem z degareliksom v potrditveni študiji faze III (N=409) so bile 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 dogodkih na mestu injiciranja.
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, vročina ali gripi podobna bolezen pojavljale nekaj ur po prejemu odmerka (pri 3%, 2% oziroma 1% bolnikov).
The injection site adverse events 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 dogodka 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%).
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.
The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (< 1%).
Dogodki, o katerih so poročali, so bili večinoma prehodni, blago do zmerno izraženi in so povzročili zelo malo prekinitev zdravljenja (< 1%).
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100).
Pogostnost spodaj navedenih neželenih učinkov je opredeljena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1. 000 do < 1/ 100).
Table 1:
4 Preglednica 1:
Frequency of adverse drug reactions reported in confirmatory phase III study (N=409).
Pogostnost neželenih reakcij na zdravilo, o katerih so poročali v potrditveni študiji faze III (N=409).
Anaemia*
anemija *
Appetite decreased
zmanjšan tek
Psychiatric disorders Nervous system disorders
Psihiatrične motnje
Insomnia Dizziness, headache
nespečnost
Loss of libido*, depression, anxiety
izguba libida *, depresija, anksioznost
Ear and labyrinth disorders
Bolezni živčevja Ušesne bolezni, vključno z motnjami labirinta
Atrio-ventricular block 1st degree QT prolongation*(see sections 4.4 and 4.5)
atrioventrikularni blok 1. stopnje podaljšanje intervala QT * (glejte poglavji 4. 4 in 4. 5)
Vascular disorders
Žilne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Hot flush*
vročinski valovi *
Respiratory, thorasic and mediastinal disorders
hipertenzija, vazovagalna sinkopa, krčnica kašelj
Diarrhoea, vomiting, abdominal discomfort, dry mouth, constipation
driska, bruhanje, nelagodje v trebuhu, suha usta, zaprtje
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Bolezni mišično - skeletnega sistema, vezivnega tkiva in kosti
Hyperhidrosis (incl. night sweats)*
hiperhidroza (vključno z nočnim znojenjem) *
Urticaria, skin hyperpigmentation, allopecia, soft nails, rash, erythema
koprivnica, hiperpigmentacija kože, plešavost, mehki nohti, izpuščaj, eritem bolečine v mišicah in kosteh, šibkost mišic
Musculoskeletal, connective tissue and bone disorders
Bolezni sečil
Musculoskeletal pain, muscular weakness
polakisurija, urgentne mikcije, okvare ledvic
Renal and urinary disorders Reproductive system and breast disorders
Motnje reprodukcije in dojk
Pollakiuria, micturition urgency, renal impairment Erectile dysfunction*, testicular atrophy*, gynaecomastia*, pelvic pain, prostatitis, prostate tenderness, retrograde ejaculation, testicular pain
erektilna disfunkcija *, atrofija mod *, ginekomastija *, bolečina v medenici, prostatitis, občutljivost prostate, retrogradna ejakulacija, bolečina v modih
Injection site adverse events
neželeni dogodki na mestu injiciranja
Chills, pyrexia, asthenia, fatigue*, Influenza-like illness
mrzlica, vročina, astenija, utrujenost *, gripi podobna bolezen porast telesne mase *
Weight increased*
lokaliziran edem hujšanje
*Known physiological consequence of testosterone suppression
* znana fiziološka posledica supresije testosterona
Changes in laboratory parameters Changes in laboratory values seen during one year of treatment were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator.
5 Spremembe laboratorijskih parametrov Spremembe laboratorijskih vrednosti, ki so jih ugotovili med enoletnim zdravljenjem, so bile za degareliks in agonist GnRH (levprorelin), ki so ga uporabili kot primerjalno zdravilo, v istih mejah.