FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Minħabba li l-kura tal-privazzjoni tal-androgen tista' ttawwal l-intervall QTc, l-użu fl-istess ħin ta' degarelix ma' prodotti mediċinali li huma magħrufa li jtawlu l-intervall QTc jew prodotti mediċinali li huma kapaċi jikkaġunaw torsades de pointes bħal prodotti mediċinali antiarritmiċi tal-klassi IA (eż. quinidine, disopyramide) jew tal-klassi III (eż. amiodarone, sotalol, dofetilide, ibutilide), methadone, moxifloxacin, mediċini antipsikotiċi, eċċ. għandhom jiġu evalwati b'attenzjoni (ara sezzjoni 4.4).
English: Urticaria, skin nodule, alopecia, pruritus, erythema
Maltese: Urtikarja, għoqod filġilda, alopeċja, ħakk,
English: Pack-size of 2 trays containing 2 powder vials, 2 solvent pre-filled syringes, 2 plunger rods, 2 vial adapters and 2 needles
Maltese: Daqs ta' pakkett ta' 2 trejs li jkun fih 2 kunjetti bit-trab, 2 siringa mimlija għal-lest bis-solvent, 2 lasti talplanġer, 2 adapters tal-kunjett u 2 labriet.
English: Figure 2: Percentage change in PSA from baseline by treatment group until day 56 (median with interquartile ranges).
Maltese: Figura 2: Bidla perċentwali fil-PSA mil-linja bażi skont il-grupp tal-kura sa Jum 56 (medjan bil-meded interquartile).
English: 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.
Maltese: segwita minn dożi ta' 160 mg (40 mg/ml) jew 80 mg (20 mg/ml) mogħtija kull xahar taħt il-ġilda, mqabbel ma' 7.5 mg leuprorelin mogħti kull xahar ġol-muskoli f'pazjenti b'kanċer tal-prostata li kienu jeħtieġu terapija tal-privazzjoni tal-androgen.
English: 2 plunger rods, 2 vial adapters and 2 injection needles.
Maltese: 2 lasti tal-planġer, 2 adapters tal-kunjett u 2 labriet għall-injezzjoni.
English: Very rare (may affect up to 1 in 10,000 people) − injection site infection, abscess and necrosis
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000) − infezzjoni, axxess u nekrożi fis-sit tal-injezzjoni
English: Pack-size of 1 tray containing: 1 powder vial, 1 solvent pre-filled syringe, 1 plunger rod, 1 vial adapter and 1 needle.
Maltese: Daqs ta' pakkett ta' 1 trej li jkun fih: 1 kunjett bit-trab, 1 siringa mimlija għal-lest bis-solvent, 1 lasta talplanġer, 1 adapter tal-kunjett u 1 labra.
English: Ferring S.p.A. Tel: +39 02 640 00 11
Maltese: Tel: +39 02 640 00 11
English: The reconstitution procedure usually takes a few minutes, but may take up to 15 minutes in some cases.
Maltese: Il-proċedura tarrikostituzzjoni normalment tieħu ftit minuti, iżda tista' tieħu, sa 15-il minuta f'xi każijiet.
English: − muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint
Maltese: − dgħjufija fil-muskoli, spażmi tal-muskoli, nefħa/ebusija fil-ġogi, osteoporożi/osteopenija, uġigħ fil-ġogi
English: 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.
Maltese: Degarelix hu antagonist selettiv tal-ormon li jerħi gonadotrophin (GnRH) li b'mod kompetittiv u b'mod riversibbli jeħel mar-riċetturi GnRH pitwitarji, b'hekk inaqqas malajr il-ħruġ ta' gonadotrophins, ormon luteinizing (LH) u ormon li jistimula l-follikulu (FSH), u b'hekk inaqqas it-tnixxija tat-testosterone (T) mit testikoli.
English: This medicine is stable for 2 hours at 25ºC.
Maltese: Din il-mediċina hi stabbli għal sagħtejn f'temperatura ta' 25ºC.
English: Prostate specific antigen (PSA) levels are lowered by 64% two weeks after administration of degarelix, 85% after one month, 95% after three months, and remained suppressed (approximately 97%) throughout the one year of treatment.
Maltese: Il-livelli tal-antiġen speċifiku għall-prostata (PSA) tnaqqsu b'64% ġimagħtejn wara l-għoti ta' degarelix, 85% wara xahar, 95% wara tliet xhur, u baqgħu mrażżna (madwar 97%) matul is-sena tal-kura.
English: In the confirmatory study comparing FIRMAGON to leuprorelin periodic electrocardiograms were performed.
Maltese: Fi studju konfermatorju li qabbel FIRMAGON ma' leuprorelin, saru elettrokardjogrammi perjodiċi.
English: Table 1: Frequency of adverse drug reactions reported in 1259 patients treated for a total of 1781 patient years (phase II and III studies) and from post-marketing reports
Maltese: Tabella 1: Frekwenza ta' reazzjonijiet avversi tal-mediċina rrappurtati f'1259 pazjent ikkurat għal total ta' 1781 sena ta' kura tal-pazjenti (studji ta' fażi
English: It caused a dosage dependent prolongation of the time to mating and to pregnancy, a reduced number of corpora lutea, and an increase in the number of pre- and post-implantation losses, abortions, early embryo/foetal deaths, premature deliveries and in the duration of parturition.
Maltese: tnaqqis fin-numru ta' corpora lutea, u żieda fin-numru ta' telf ta' qabel u wara l-impjantazzjoni, aborti, imwiet bikrija tal-embriju/tal-fetu, twelidijiet prematuri u fit-tul tal-ħin tal-ħlas.
English: Degarelix has been investigated in a pharmacokinetic study in patients with mild to moderate hepatic impairment.
Maltese: Degarelix kien investigat fi studju farmakokinetiku f'pazjenti b'indeboliment epatiku li kien minn ħafif sa moderat.
English: The median time to testosterone >1.5 ng/mL (above lower limit of normal range) was 168 days.
Maltese: Il-ħin medjan għal livell ta' testosterone ta' >1.5 ng/mL ('il fuq mil-limitu l-baxx tal-medda normali) kien ta' 168 jum.
English: Choose a different injection site and inject 3 ml.
Maltese: Agħżel post differenti fejn tagħti l injezzjoni u injetta 3 ml.
English: Osteoporosis/osteopenia, arthralgia muscular weakness, muscle spasms, joint swelling/stiffness
Maltese: Osteoporożi/osteopenija, artralġja, dgħjufija filmuskoli, spażmi talmuskoli, nefħa/ebusija fil-ġogi
English: − The other ingredient of the powder is mannitol (E 421).
Maltese: - Is-sustanza l-oħra tat-trab hi mannitol (E 421).
English: Transient chills, fever or influenza like illness were reported to occur hours after dosing (in 3%, 2% and 1% of patients, respectively).
Maltese: Tkexkix ta' bard temporanju, deni jew mard qisu influwenza kienu rrappurtati li seħħew fis-sigħat ta' wara d-dożaġġ (fi 3%, 2% u 1% tal pazjenti, rispettivament).
English: FIRMAGON 80 mg powder for injection degarelix
Maltese: FIRMAGON 80 mg trab għall-injezzjoni degarelix
English: Cmax degarelix plasma concentration decreases in a biphasic fashion, with a mean terminal half-life (t½) of 29 days for the maintenance dose.
Maltese: Wara li s-Cmax tal-konċentrazzjoni ta' degarelix fil-plażma tonqos b'mod bifażiku, bil-medja tal-half-life (t½) terminali ta' madwar 29 jum għad-doża tal-manteniment.
English: Each vial contains 120 mg degarelix (as acetate).
Maltese: Kull kunjett fih 120 mg ta' degarelix (bħala acetate).
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).
Maltese: FIRMAGON ma' leuprorelin mogħti perjodikament (kull xahar), saru elettrokardjogrammi (ECGs); iż-żewġ terapiji wrew intervalli tal-QT/QTcs li kienu jaqbżu 450 msek f'madwar 20% tal-pazjenti, u 500 msek f'1%
English: FIRMAGON 120 mg powder for injection degarelix
Maltese: FIRMAGON 120 mg trab għall-injezzjoni degarelix
English: Pack sizes
Maltese: Effett fit-tul
English: 3 plunger rods, 3 vial adapters and 3 injection needles.
Maltese: 3 lasti tal-planġer, 3 adapters tal-kunjett u 3 labriet għall-injezzjoni.
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%).
Maltese: 28% u fi 17% tal-pazjenti, rispettivament, u b'mod inqas frekwenti kienu rrappurtati nefħa (6%), ebusija
English: This difference was statistically significant (p<0.001) for the pre-specified analysis at day 14 and day 28.
Maltese: 001) għall-analiżi pre-speċifika f'jum 14 u jum 28.
English: Rhabdomyolysis
Maltese: IL-KUNJETTI
English: Other medicines and FIRMAGON
Maltese: Mediċini oħra u FIRMAGON
English: Pharmacotherapeutic group: Endocrine therapy, Other hormone antagonists and related agents, ATC code: L02BX02
Maltese: Terapija endokrina, Antagonisti oħrajn tal-ormoni u sustanzi relatati, Kodiċi
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
Maltese: Daqs tal-pakkett ta' 2 trejs li jkun fih: 2 kunjetti b'120 mg ta' degarelix (trab) 2 siringi mimlija għal-lest bi 3 ml ta' solvent 2 lasti tal-planġer
English: Table 2: Percentage of patients attaining T≤0.5 ng/ml after start of treatment.
Maltese: Tabella 2: Perċentwali ta' pazjenti li kisbu T≤0.5 ng/ml wara l-bidu tal-kura.
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.
Maltese: Id-daqs tat-tumur ma tkejjilx direttament matul il-programm tal-provi kliniċi, iżda kien hemm rispons utli indirett għat-tumur kif muri minn tnaqqis ta' 95% wara 12-il xahar fil-medja tal-PSA għal degarelix.
English: Three months therapy with degarelix (240/80 mg dose regimen) resulted in a 37% reduction in prostate volume as measured by trans-rectal ultrasound scan (TRUS) in patients requiring hormonal therapy prior to radiotherapy and in patients who were candidates for medical castration.
Maltese: Tliet xhur ta' terapija b'degarelix (programm ta' kura ta' doża ta' 240/80 mg) irriżulta fi tnaqqis ta' 37% filvolum tal-prostata kif imkejjel minn trans-rectal ultrasound scan (TRUS) f'pazjenti li kienu jeħtieġu terapija ormonali qabel ir-radjuterapija u f'pazjenti li kienu kandidati għal kastrazzjoni medika.
English: There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation after up to 5.5 years of treatment.
Maltese: M'hemm l-ebda indikazzjoni li l-effikaċja jew is-sigurtà tal-kura b'FIRMAGON tkun affettwata mill-formazzjoni tal-antikorp wara sa 5.5 snin ta' kura.
English: Anaphylactic reactions
Maltese: Indeboliment renali
English: Ferring Magyarország Gyógyszerkereskedelmi Kft. Tel: +36 1 236 3800 ferring@ferring.hu
Maltese: Tel: +36 1 236 3800 ferring@ferring.hu
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).
Maltese: FIRMAGON jista' jinterferixxi ma' xi mediċini li jintużaw biex jikkuraw problemi fir-ritmu tat-taħbit talqalb (eż. quinidine, procainamide, amiodarone u sotalol) jew mediċini oħrajn li jista' jkollhom effett fuq irritmu tal-qalb (eż. methadone (jintuża għas-solliev tal-uġigħ u bħala parti minn programm ta' detossifikazzjoni mill-vizzju tad-droga), moxifloxacin, mediċini antipsikotiċi).
English: Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer in adult male patients.
Maltese: Degarelix hu imblukkatur sintetiku tal-ormoni li jintuża fil-kura ta' kanċer tal-prostata f'pazjenti rġiel adulti.
English: * Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Maltese: * L-istabbiltà kimika u fiżika waqt l-użu ntweriet li ddum sagħtejn f'temperatura ta' 25ºC.
English: Each vial contains 80 mg degarelix (as acetate).
Maltese: Kull kunjett fih 80 mg ta' degarelix (bħala acetate).
English: 46.4 ng/ml)
Maltese: • 17.4 ng/ml (medda interquartile:
English: The pharmacokinetics of degarelix has been investigated after single intravenous administration in subjects with mild to moderate hepatic impairment (see section 5.2).
Maltese: doża waħda ġol-vini f'individwi li kellhom indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 5.2).
English: Injection site adverse reactions
Maltese: Lista tabulata ta' reazzjonijiet avversi
English: 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.
Maltese: Studji kliniċi wrew li t-trażżin tat-testosterone (T) iseħħ immedjatment wara l-għoti tad-doża tal-bidu b'96% tal-pazjenti li jkollhom livelli ta' testosterone fis-serum li jikkorrispondu għall-kastrazzjoni medika (T≤0.5 ng/mL) wara tlett ijiem u 100% wara xahar.
English: • for the leuprorelin 7.5 mg treatment group 17.4 ng/ml (interquartile range: P25 8.4 ng/ml, P75
Maltese: P25 8.4 ng/ml, P75 56.5 ng/ml) għall-grupp tal-kura ta' leuprorelin
English: The lowest effective maintenance dose of 80 mg degarelix was chosen.
Maltese: L-inqas doża effettiva tal-manteniment ta' 80 mg ta' degarelix kienet magħżula.
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.
Maltese: 409 pazjenti fil-grupp ta' degarelix u erbgħa (2%) minn 201 pazjent fil-grupp ta' 7.5 mg leuprorelin, kellhom
English: Unlike GnRH agonists, GnRH antagonists do not induce a LH surge with subsequent testosterone surge/tumour stimulation and potential symptomatic flare after the initiation of treatment.
Maltese: B'kuntrast mal-agonisti ta' GnRH, l-antagonisti ta' GnRH ma jikkaġunawx żieda f'daqqa f'LH, li sussegwentement tikkawża żieda f'daqqa fit-testosterone/stimulazzjoni tat-tumur u l aggravament sintomatiku potenzjali wara l-bidu tal-kura.
English: Results of the confirmatory Phase III study
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: 1 plunger rod, 1 vial adapter and 1 injection needle.
Maltese: 1 lasta tal-planġer, 1 adapter tal-kunjett u 1 labra għall-injezzjoni.
English: The serum concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone.
Maltese: Il-konċentrazzjoni ta' dihydrotestosterone (DHT) fis-serum tonqos b'mod jixbaħ lit-testosterone.
English: Manufacturer
Maltese: 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.
Maltese: Doża waħda ta' 240 mg ta' degarelix, segwita minn doża tal-manteniment ta' 80 mg kull xahar, malajr jikkawżaw tnaqqis fil-konċentrazzjonijiet ta' LH, FSH u sussegwentement tat-testosterone.
English: 3 injection needle
Maltese: 3 labriet għall-injezzjoni
English: Ferring Pharmaceuticals Ltd. Tel: +44 844 931 0050 contact2@ferring.com
Maltese: Tel: +44 844 931 0050 contact2@ferring.com
English: Tel: +48 22 246 06 80 ferring@ferring.pl
Maltese: Ferring Pharmaceuticals Poland Sp. z o.o. Tel: +48 22 246 06 80 ferring@ferring.pl
English: night sweats)*, rash
Maltese: Iperidrosi (li tinkludi għaraq matul il-lejl)*, raxx
English: Glucose tolerance
Maltese: Tolleranza għaz-zokkor
English: − malaise
Maltese: FIS-SUQ
English: 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.
Maltese: Valuri li kienu anormali b'mod ċar (>3*ULN) għal transaminase tal-fwied (ALT, AST u GGT) kienu osservati f'2-6% tal-pazjenti b'valuri normali qabel il-kura, wara li ngħataw kura biż-żewġ prodotti mediċinali.
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
Maltese: Daqs tal-pakkett ta' 3 trejs li jkun fih 3 kunjetti bi 80 mg ta' degarelix (trab) 3 siringi mimlija għal-lest b'4.2 ml ta' solvent 3 lasti tal-planġer
English: Transfer all solvent to the powder vial.
Maltese: Ittrasferixxi s-solvent kollu fil-kunjett bittrab.
English: E.J.
Maltese: U L-UŻU.
English: From day 56 to day 364 there were no significant differences between degarelix and the comparator in the percentage change from baseline.
Maltese: Minn jum 56 sa jum 364 ma kien hemm l-ebda differenzi sinifikanti bejn degarelix u l-komparatur fil-bidla perċentwali mil-linja bażi.
English: The therapeutic effect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels.
Maltese: L-effett terapewtiku ta' degarelix għandu jiġi mmonitorjat permezz tal-parametri kliniċi u l-livelli fis-serum ta' antiġen speċifiku għall-prostata (PSA).
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 ruħ)
English: Response Rate (confidence intervals)* * Kaplan Meier estimates within group
Maltese: Nru. ta' dawk li rrispondew 202 Rata ta' Rispons (intervalli tal-kunfidenza)* * Stimi Kaplan Meier fil-grupp Il-kisba ta' tnaqqis tal-antiġen speċifiku għall-prostata (PSA)
English: In healthy men, approximately 20-30% of a single intravenously administered dose is excreted in the urine, suggesting that 70-80% is excreted via the hepato-biliary system.
Maltese: F'irġiel b'saħħithom, madwar 20-30% ta' doża waħda mogħtija ġol-vina titneħħa fl-awrina, li jissuġġerixxi li 70-80% titneħħa permezz tas-sistema epatobiljari.
English: Plunger rods
Maltese: TAGĦRIF
English: 1 vial with powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent.
Maltese: 1 kunjett bi 80 mg ta' degarelix (trab) u 1 siringa mimlija għal-lest b'4.2 ml ta' solvent.
English: 2 injection needles
Maltese: 2 labriet għall-injezzjoni
English: In a study involving patients with rising PSA after localised therapy (mainly radical prostatectomy and radiation) were administered FIRMAGON for seven months followed by a seven months monitoring period.
Maltese: Fi studju li kien jinvolvi pazjenti b'livelli ta' PSA li jkunu qed qed jogħlew wara terapija lokalizzata (il-biċċa l-kbira prostatektomija radikali u radjazzjoni), dawn ingħataw FIRMAGON għal seba' xhur segwit minn perjodu ta' monitoraġġ ta' seba' xhur.
English: Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet li ddum sagħtejn f'temperatura ta' 25ºC.
English: − loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain
Maltese: − telf ta' aptit sesswali, uġigħ testikulari, uġigħ pelviku, insuffiċjenza fl-ejakulazzjoni, irritazzjoni ġenitali,
English: FIRMAGON is administered as a subcutaneous injection in the abdominal region.
Maltese: FIRMAGON jingħata bħala injezzjoni taħt il-ġilda fiż-żona addominali.
English: 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).
Maltese: Il-ħin medjan għall-irkuprar tal-livell ta' testosterone (>0.5 ng/mL, fuq il-livell ta' kastrazzjoni) wara t-twaqqif tal-kura kien ta' 112-il jum (magħduda mill-bidu tal-kura, i.e. 28 jum wara l-aħħar injezzjoni).
English: FIRMAGON 80 mg powder and solvent for solution for injection degarelix
Maltese: FIRMAGON 80 mg trab u solvent għal soluzzjoni għall-injezzjoni degarelix
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
Maltese: Daqs tal-pakkett ta' 1 trej li jkun fih 1 kunjett bi 80 mg ta' degarelix (trab) 1 siringa mimlija għal-lest b'4.2 ml ta' solvent 1 lasta tal-planġer
English: Surge was defined as testosterone exceeding baseline by ≥15% within the first 2 weeks.
Maltese: Iż-żieda f'daqqa kienet definita bħala testosterone li jaqbeż il-linja bażi bi ≥15% fl-ewwel ġimagħtejn.
English: Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ml.
Maltese: Degarelix hu effettiv fil-kisba u l-manteniment tat-trażżin tat-testosterone taħt sew tal-livell tal-kastrazzjoni medika ta' 0.5 ng/ml.
English: Pre-filled glass (type I) syringe with elastomer plunger stopper, tip cap and line-marking at 4 ml containing 4.2 ml solvent
Maltese: Siringa tal-ħġieġ (tip I) mimlija għal-lest b'tapp planġer tal-elastomer, għatu tat-tarf u marka ta' linja f'4 ml li fiha 4.2 ta' solvent
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.
Maltese: M'hemmx użu rilevanti ta' FIRMAGON fi tfal u adolexxenti fil-kura ta' pazjenti rġiel adulti b'kanċer tal prostata avvanzat dipendenti fuq l-ormoni.
English: Glass (type I) vial with bromobutyl rubber stopper and aluminium flip-off seal containing 80 mg powder for solution for injection
Maltese: Kunjett tal-ħġieġ (tip I) b'tapp tal-lastku tal-bromobutyl u siġill tal-aluminju li jinfetaħ b'saba' wieħed li fih 80 mg trab għal soluzzjoni għall-injezzjoni
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.
Maltese: III (N=409) kien fl istess medda għal degarelix u agonist ta' GnRH (leuprorelin) li ntuża bħala komparatur.
English: Elderly, hepatically or renally impaired patients:
Maltese: Pazjenti anzjani, u dawk b'indeboliment epatiku jew renali:
English: − musculoskeletal pain and discomfort
Maltese: − uġigħ u skonfort muskoloskeletriku
English: FIRMAGON 120 mg powder and solvent for solution for injection degarelix
Maltese: FIRMAGON 120 mg trab u solvent għal soluzzjoni għall-injezzjoni degarelix
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.
Maltese: − Kwalunkwe problemi kardjovaskulari jew problemi bir-ritmu tal-qalb (arritmija), jew qed tiġi kkurat/a b'mediċini għal din il-kundizzjoni.
English: • Risk Management Plan (RMP)The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Remove the cover from the vial adapter pack.
Maltese: Neħħi l-għatu mill-pakkett tal-adapters talkunjett.
English: The prostate volume reduction was similar to that attained with goserelin plus anti-androgen protection.
Maltese: It-tnaqqis fil-volum tal-prostata kien simili għal dak li nkiseb bi goserelin flimkien ma' protezzjoni antiandroġena kontra l aggravar .
English: Dyspnoea
Maltese: Leuprorelin
English: Pre-filled glass (type I) syringes with elastomer plunger stopper, tip cap and line-marking at 3 ml containing 3 ml solvent
Maltese: Siringi tal-ħġieġ (tip I) mimlija għal-lest b'tapp planġer tal-elastomer, għatu tat-tarf u marka ta' linja fi 3 ml li fihom 3 ml ta' solvent