FrancophonIA/ELRC3.0 huggingface dataset:
English: − decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar/diabetes mellitus, increased cholesterol, changes in blood calcium, decreased weight
Slovenian: − 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
English: − increased weight, nausea, diarrhoea, elevated levels of some liver enzymes
Slovenian: − zvečana telesna masa, navzea, driska, zvišana raven nekaterih jetrnih encimov
English: No significant metabolites were detected in plasma samples after subcutaneous administration.
Slovenian: V vzorcih plazme niso po subkutani aplikaciji odkrili nikakršnih pomembnejših presnovkov.
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.
Slovenian: 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.
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.
Slovenian: Primarni namen je bil dokazati, da je degareliks med enoletnim zdravljenjem učinkovit za doseganje in vzdrževanje supresije testosterona pod 0,5 ng/ml.
English: Pollakiuria, micturition urgency, dysuria, nocturia, renal impairment, incontinence
Slovenian: Bolezni sečil polakisurija, urgentne mikcije, dizurija, nokturija, okvare ledvic, inkontinenca
English: There is no relevant use of FIRMAGON in children and adolescents in the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Slovenian: 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 .
English: Day 14 Day 28
Slovenian: 28. dan
English: Pack-size of 3 trays containing:
Slovenian: Pakiranje s 3 podstavki vsebuje:
English: Day 1 Day 3
Slovenian: 3. dan
English: Pack-size of 2 trays containing:
Slovenian: Pakiranje z 2 podstavkoma vsebuje:
English: Rare (may affect up to 1 in 1,000 people)
Slovenian: Redki (pojavijo se največ pri 1 od 1.000 bolnikov)
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).
Slovenian: (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).
English: − The active substance is degarelix.
Slovenian: − Zdravilna učinkovina je degareliks.
English: Cardiovascular disease
Slovenian: Srčnožilne bolezni
English: Precautions must be taken to avoid accidental injection into a vein.
Slovenian: Oseba, ki injicira zdravilo, mora paziti, da zdravila ne bi pomotoma injicirala v veno.
English: In female reproduction toxicity studies degarelix revealed findings expected from the pharmacological properties.
Slovenian: Študije toksičnosti za razmnoževanje pri samicah so pokazale ugotovitve, kakršne pričakujemo zaradi farmakoloških lastnosti zdravila.
English: Tiredness and dizziness are common side effects that may impair your ability to drive and use machines.
Slovenian: Utrujenost in omotica sta pogosta neželena učinka, ki vam lahko zmanjšata sposobnost upravljanja vozil in strojev.
English: • for the degarelix 240/80 mg treatment group 19.8 ng/ml (interquartile range: P25 9.4 ng/ml, P75
Slovenian: • 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);
English: The median time to testosterone >1.5 ng/mL (above lower limit of normal range) was 168 days.
Slovenian: 28 dni po zadnjem injiciranju), mediani čas do ravni testosterona > 1,5 ng/mL (nad spodnjo mejo normale) je bil 168 dni.
English: No. of responders
Slovenian: Število responderjev
English: Each vial contains 120 mg degarelix (as acetate).
Slovenian: Ena viala vsebuje 120 mg degareliksa (v obliki acetata).
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.
Slovenian: To naredite tako, da s palcem in kazalcem primete kožo na trebuhu, dvignete podkožno tkivo in iglo globoko zabodete pod kotom vsaj 45 stopinj.
English: 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.
Slovenian: Ni znano, do kakšne mere je to zmanjšanje hematoloških vrednosti povzročila osnovna bolezen, t.j.
English: − excessive sweating (including night sweats), rash
Slovenian: − čezmerno potenje (z nočnim znojenjem vred), izpuščaj
English: Anti-degarelix antibodies
Slovenian: Protitelesa proti degareliksu
English: Monitoring of liver function in patients with known or suspected hepatic disorder is advised during treatment.
Slovenian: Pri bolnikih z dokazano ali možno boleznijo jeter je med zdravljenjem priporočljivo spremljati delovanja jeter.
English: Elderly, hepatically or renally impaired patients:
Slovenian: Starejši,bolniki z okvarami jeter ali ledvic:
English: FIRMAGON is a powder and solvent for solution for injection.
Slovenian: Zdravilo FIRMAGON je prašek in vehikel za raztopino za injiciranje.
English: • for the leuprorelin 7.5 mg treatment group 17.4 ng/ml (interquartile range: P25 8.4 ng/ml, P75
Slovenian: • pri skupini, zdravljeni z levprorelinom v odmerku 7,5 mg, 17,4 ng/ml (interkvartilni razpon: P25 8,4 ng/ml, P75 56,5 ng/ml).
English: From baseline to end of study the median change for FIRMAGON was 12.0 msec and for leuprorelin it was 16.7 msec.
Slovenian: Od izhodišča do konca študije je bila mediana sprememba pri zdravilu FIRMAGON 12,0 msek, pri levprorelinu pa 16,7 msek.
English: − trouble sleeping, tiredness, dizziness, headache
Slovenian: − nespečnost, utrujenost, omotica, glavobol
English: No target organ toxicity was observed from acute, subacute and chronic toxicity studies in rats and monkeys following subcutaneous administration of degarelix.
Slovenian: V študijah akutne, subakutne in kronične toksičnosti na podganah in opicah po subkutanem dajanju degareliksa niso ugotovili nikakršne toksičnosti za tarčne organe.
English: Each vial contains 80 mg degarelix (as acetate).
Slovenian: Ena viala vsebuje 80 mg degareliksa (v obliki acetata).
English: Seek medical advice straight away if you develop a severe rash, itching or shortness of breath or difficulty breathing.
Slovenian: Če se pri vas pojavijo hudi izpuščaji, srbenje ali zadihanost ali oteženo dihanje takoj poiščite zdravniško pomoč.
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.
Slovenian: Primeri so bili dobro dokumentirani, brez očitne alterntivne etiologije ali drugih možnih vzročnih dejavnikov, združljivimi s časom pojava in prenehanjem ter povečanim krvnim CK. Degareliks je bil ukinjen v vseh primerih.
English: 1 plunger rod, 1 vial adapter and 1 injection needle.
Slovenian: 1 bat brizge, 1 adapter viale in 1 injekcijsko iglo.
English: Renal impairment Degarelix has not been studied in patients with severe renal impairment and caution is therefore warranted.
Slovenian: Pri bolnikih s težkimi okvarami ledvic degareliksa niso proučevali, zato je potrebna previdnost.
English: 2 plunger rods, 2 vial adapters and 2 injection needles.
Slovenian: 2 bata brizge, 2 adapterja viale in 2 injekcijski igli.
English: Pack-size of 1 tray containing:
Slovenian: Pakiranje z 1 podstavkom vsebuje:
English: Bilirubin increased, alkaline phosphatase increased
Slovenian: žolčnika in žolčevodov zvišane jetrne transaminaze zvišan bilirubin, zvišana alkalna fosfataza
English: The prostate volume reduction was similar to that attained with goserelin plus anti-androgen protection.
Slovenian: Velikost prostate se je zmanjšala v podobni meri kot pri zdravljenju z goserelinom v kombinaciji z antiandrogensko zaščito proti nihanju ravni testosterona.
English: Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 80 mg powder for solution for injection
Slovenian: Steklena (tip I) viala z bromobutilnim gumijastim zamaškom in aluminijasto zaščitno zaporko, ki vsebuje 80 mg praška za raztopino za injiciranje
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.
Slovenian: Trije (<1 %) od 409 bolnikov v skupini z degareliksom in štirje (2 %) od 201 bolnikov v skupini, zdravljeni z levprorelinom v odmerku 7,5 mg, so imeli QTcF ≥ 500 msek.
English: night sweats)*, rash
Slovenian: (vključno z nočnim znojenjem)*,
English: − skin redness, loss of hair, skin nodule, numbness
Slovenian: − pordelost kože, izpadanje las, vozlič v koži, odrevenelost
English: 8 cases of rhabdomyolysis have cumulativly been reported with degarelix.
Slovenian: Pri zdravljenju z degareliksom so poročali o 8 primerih rabdomiolize.
English: − Any cardiovascular conditions or heart rhythm problems (arrythmia), or are being treated with medicines for this condition.
Slovenian: Povejte svojemu zdravniku, če imate kaj od naslednjega: − kakršnekoli srčnožilne težave ali težave s srčnim ritmom (aritmija) ali se zdravite z zdravili, ki se uporabljajo za zdravljenje takih težav.
English: − loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain
Slovenian: − izguba spolnega poželenja, bolečina v modih, bolečina v medenici, nezmožnost ejakulacije, draženje spolovil, bolečina v dojkah
English: EU/1/08/504/001
Slovenian: EU/1/08/504/001 EU/1/08/504/003
English: Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 4 ml containing 4.2 ml solvent
Slovenian: Napolnjena steklena (tip I) injekcijska brizga z batno zaporko iz elastomera, kapico in črtno oznako pri 4 ml, ki vsebuje 4,2 ml vehikla
English: The lack of intrinsic effect of degarelix on cardiac repolarisation (QTcF), heart rate, AV conduction, cardiac depolarisation, or T or U wave morphology was confirmed in a thorough QT study in healthy subjects (N=80) receiving an i.v.
Slovenian: Odsotnost intrinzičnega učinka degareliksa na repolarizacijo srčnih prekatov (QTcF), srčni utrip, prevodnost AV-vozla, depolarizacijo srčnih prekatov ali morfologije vala T ali U je bila potrjena v temeljiti študiji intervala QT pri zdravih osebah (N = 80), ki so prejemale intravensko infuzijo učinkovine degareliks več kot 60 minut in so dosegle povprečno Cmax 222 ng/mL, kar predstavlja približno 3- do 4-kratno vrednost Cmax, prejeto med zdravljenjem raka na prostati.
English: Dose adjustment is not necessary in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter prilagajanje odmerka ni potrebno.
English: − reduced size of testicles, breast swelling, impotence
Slovenian: − zmanjšanje mod, otekanje dojk, impotenca.
English: Perform a deep subcutaneous injection.
Slovenian: Vsebino brizge injicirajte globoko subkutano.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE FOR SOLVENT 3 ml water for injections
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA ZA VEHIKEL 3 ml voda za injekcije
English: Urticaria, skin nodule, alopecia, pruritus, erythema
Slovenian: izpuščaj koprivnica, vozlič v koži, plešavost, pruritus, eritem
English: Turn the vial upside down and draw up to the line mark on the syringe for injection.
Slovenian: Zasukajte vialo na glavo in povlecite iz nje količino do črtne oznake na brizgi za injiciranje.
English: Hot flush*
Slovenian: Žilne bolezni vročinski valovi*
English: Hyperglycemia/Diabetes mellitus, cholesterol increased, weight decreased, appetite decreased, changes in blood calcium
Slovenian: hiperglikemija /diabetes mellitus, zvišan holesterol, zmanjšana telesna masa, zmanjšan tek, spremembe kalcija v krvi
English: Avoid shaking to prevent foam formation.
Slovenian: Viale ne stresajte, da ne bo nastala pena.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE FOR SOLVENT 4.2 ml water for injections
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA ZA VEHIKEL 4,2 ml voda za injekcije
English: Glass (type I) vials with bromobutyl stopper and aluminium flip-off seal containing 120 mg powder for solution for injection
Slovenian: Stekleni (tip I) viali z bromobutilnim gumijastim zamaškom in aluminijasto zaščitnoodtržno zaporko, ki vsebujeta po 120 mg praška za raztopino za injiciranje
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).
Slovenian: kinidina, prokainamida, amiodarona in solatola), ali drugih zdravil, ki lahko vplivajo na srčni ritem (npr. metadona (uporablja se za lajšanje bolečine in pri odvajanju od zasvojenosti z zdavili),
English: No signs of increased exposure in the hepatically impaired subjects were observed compared to healthy subjects.
Slovenian: primerjavi z zdravimi osebami niso pri osebah z okvaro jeter ugotovili nikakršnih znakov zvečane izpostavljenosti.
English: − muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint
Slovenian: − šibkost mišic, mišični spazmi, otekanje/otrdelost sklepov, osteoporoza/osteopenija, bolečine v sklepih
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
English: If you get any of the side effects, talk to your doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: The pack contains two vials of powder and two pre-filled syringes with solvent that must be prepared for subcutaneous injection.
Slovenian: Zloženka vsebuje dve viali s praškom in dve napolnjeni injekcijski brizgi z vehiklom, ki ju je treba pripraviti za subkutano injekcijo.
English: 1 vial adapter
Slovenian: 1 adapter viale
English: 2 vial adapters
Slovenian: 2 adapterja viale
English: − Keep this leaflet.
Slovenian: izpuščaj koprivnica,
English: − If you get any of the side effects, talk to your doctor.
Slovenian: − Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: Gynaecomastia*, testicular atrophy*, erectile dysfunction*
Slovenian: Motnje reprodukcije in dojk ginekomastija*, atrofija mod*, erektilna disfunkcija*
English: − allergic reactions, hives, itching
Slovenian: − alergijske reakcije, koprivnica, srbenje
English: Pack-size of 1 tray containing: 1 powder vial, 1 solvent pre-filled syringe, 1 plunger rod, 1 vial adapter and 1 needle.
Slovenian: Pakiranje z 1 podstavkom vsebuje: 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom, 1 bat brizge,1 adapter viale in 1 iglo.
English: 3 vial adapter
Slovenian: 3 adapterje viale
English: SC use only
Slovenian: Samo za s.c. uporabo.
English: A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
Slovenian: Pri moških, ki so imeli orhiektomijo ali so jih zdravili s kakim agonistom GnRH, so opazili zmanjšano toleranco za glukozo.
English: Pack sizes
Slovenian: Bat brizge
English: 1 injection needle
Slovenian: 1 injekcijska igla
English: − Liver disease.
Slovenian: − bolezni ledvic.
English: Inject 4 ml of FIRMAGON 80 mg slowly,
Slovenian: Počasi injicirajte 4 ml zdravila FIRMAGON 80 mg takoj po rekonstituciji.
English: Remove the cap of the pre-filled syringe.
Slovenian: Snemite kapico z napolnjene injekcijske brizge.
English: How to store FIRMAGON
Slovenian: Shranjevanje zdravila FIRMAGON
English: Marked decrease in haematological values, hematocrit (≤0.37) and hemoglobin (≤115 g/l) were seen in 40% and 13-15%,
Slovenian: Znatno zmanjšanje hematoloških vrednosti, hematokrita (≤0,37) pri 40 % bolnikov in hemoglobina (≤115 g/l) pri 13-15 % bolnikov, so ugotovili po zdravljenju z obema zdraviloma pri bolnikih, ki so imeli pred zdravljenjem normalne vrednosti.
English: Prepare the pre-filled syringe by attaching the plunger rod.
Slovenian: Pripravite napolnjeno injekcijsko brizgo, tako da pritrdite bat brizge.
English: Pack-size of 2 trays containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles
Slovenian: Pakiranje z 2 podstavkoma vsebuje 2 viali s praškom, 2 napolnjeni injekcijski brizgi z vehiklom, 2 bata brizge, 2 adapterja viale in 2 igli.
English: The pack contains one vial of powder and one pre-filled syringe with solvent that must be prepared for subcutaneous injection.
Slovenian: Zloženka vsebuje eno vialo praška in eno napolnjeno injekcijsko brizgo z vehiklom, ki ga je treba pripraviti za subkutano injekcijo.
English: Pack-size of 3 trays containing: 3 powder vials, 3 solvent pre-filled syringes, 3 plunger rods, 3 vial adapters and 3 needles.
Slovenian: Pakiranje s 3 podstavki vsebuje: 3 viale s praškom, 3 napolnjene injekcijske brizge z vehiklom, 3 bate brizge, 3 adapterje viale in 3 igle.
English: FIRMAGON is administered as a subcutaneous injection in the abdominal region.
Slovenian: Zdravilo FIRMAGON se daje s subkutano injekcijo v predel trebuha.
English: Busuttil Ltd. Tel: +356 21447184 info@ejbusuttil.com
Slovenian: Tel: +356 21447184 info@ejbusuttil.com
English: Hyperglycemia/Diabe tes mellitus, cholesterol increased, weight decreased, appetite decreased, changes in blood calcium
Slovenian: hiperglikemija/diab etes mellitus, zvišan holesterol, zmanjšana telesna masa, zmanjšan tek, spremembe kalcija v krvi
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se pri največ 1 od 100 bolnikov)
English: Hypertension, vasovagal reaction (incl.
Slovenian: hipertenzija, vazovagalna reakcija (vključno s hipotenzijo)
English: Bone density has not been measured during treatment with degarelix.
Slovenian: Med zdravljenjem z degareliksom kostne gostote niso merili.
English: Mental impairment, hypoaesthesia
Slovenian: Bolezni živčevja omotica, glavobol duševne motnje, hipestezija
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (pojavijo se pri največ 1 od 10 bolnikov)
English: No testosterone microsurges were observed after re-injection during degarelix treatment.
Slovenian: Po ponovnem injiciranju med zdravljenjem z degareliksom ni prišlo do porasta testosterona.
English: Pregnancy and breast-feeding There is no relevant indication for use of FIRMAGON in women.
Slovenian: Ustreznih indikacij za uporabo zdravila FIRMAGON pri ženskah ni. Plodnost
English: methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics ).
Slovenian: moksifloksacina (antibiotik), antipsihotikov).
English: 2 vials with powder containing 120 mg of degarelix and 2 pre-filled syringes with 3 ml of solvent.
Slovenian: 2 viali s praškom, ki vsebujeta po 120 mg degareliksa, in 2 napolnjeni injekcijski brizgi s 3 ml vehikla.
English: FIRMAGON 120 mg powder for injection degarelix
Slovenian: FIRMAGON 120 mg prašek za injekcijo degareliks
English: 1 vial with powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent.
Slovenian: 1 vialo s praškom, ki vsebuje 80 mg degareliksa, in 1 napolnjeno injekcijsko brizgo s 4,2 ml vehikla.
English: FIRMAGON 80 mg powder for injection degarelix
Slovenian: FIRMAGON 80 mg prašek za injekcijo degareliks
English: Malaise, peripheral oedema
Slovenian: periferni edemi
English: Pack-size of 2 trays containing: 2 vials with 120 mg degarelix (powder) 2 pre-filled syringes with 3 ml solvent 2 plunger rods
Slovenian: Pakiranje z 2 podstavkoma vsebuje 2 viali s 120 mg degareliksa (prašek) 2 napolnjeni injekcijski brizgi s 3 ml vehikla 2 bata brizge
English: 3 injection needle
Slovenian: 3 injekcijske igle
English: Ferring Magyarország Gyógyszerkereskedelmi Kft. Tel: +36 1 236 3800 ferring@ferring.hu
Slovenian: Tel: +36 1 236 3800 ferring@ferring.hu
English: Name and address of the manufacturer responsible for batch release Ferring GmbH
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: Constipation, vomiting, abdominal pain, abdominal discomfort, dry mouth
Slovenian: bolečine v trebuhu, nelagodje v trebuhu, suha usta
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).
Slovenian: Ker zdravljenje z deprivacijo androgenov lahko podaljša interval QTc, moramo skrbno ovrednotiti sočasno uporabo degareliksa z zdravili, za katere je znano, da podaljšujejo interval QTc, ali zdravili, ki lahko sprožijo torsades de pointes, n.pr.
English: − Diabetes mellitus.
Slovenian: − sladkorno bolezen.
English: Anaphylactic reactions
Slovenian: hipertenzija, vazovagalna reakcija
English: Ferring S.p.A. Tel: +39 02 640 00 11
Slovenian: Tel: +39 02 640 00 11
English: Pre-filled glass (type I) syringes with elastomer plunger stopper, tip cap and line-marking at 3 ml containing 3 ml solvent
Slovenian: Napolnjeni stekleni (tip I) injekcijski brizgi z batno zaporko iz elastomera, kapico in črtno oznako pri 3 ml,
English: − frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at night, impaired renal function, incontinence
Slovenian: oteženo odvajanje vode ali bolečine pri odvajanju vode, odvajanje vode ponoči, zmanjšano delovanje ledvic, inkontinenca − zameglen vid
English: Vial adapter
Slovenian: Adapter viale
English: Pack-size of 3 trays containing 3 vials with 80 mg degarelix (powder) 3 pre-filled syringe with 4.2 ml solvent 3 plunger rod
Slovenian: Pakiranje s 3 podstavki vsebuje 3 viale z 80 mg degareliksa (prašek) 3 napolnjene injekcijske brizge s 4,2 ml vehikla 3 bate brizge
English: Pack-size of 1 tray containing 1 vial with 80 mg degarelix (powder) 1 pre-filled syringe with 4.2 ml solvent 1 plunger rod
Slovenian: Pakiranje z 1 podstavkom vsebuje 1 viala z 80 mg degareliksa (prašek) 1 napolnjena injekcijska brizga s 4,2 ml vehikla 1 bat brizge
English: − musculoskeletal pain and discomfort
Slovenian: − bolečine in nelagodje v mišicah in kosteh
English: Testicular pain, breast pain, pelvic pain, genital irritation, ejaculation failure
Slovenian: bolečina v modih, bolečina v dojkah, bolečina v medenici, draženje spolovil, nezmožnost ejakulacije
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FIRMAGON 80 mg powder and solvent for solution for injection
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA FIRMAGON 80 mg prašek in vehikel za raztopino za injiciranje