qanastek/EMEA-V3 huggingface dataset:
Renal and urinary disorders Reproductive system and breast disorders
Pollakijurja, urġenza biex tagħmel l- awrina, indeboliment renali
Pollakiuria, micturition urgency, renal impairment Erectile dysfunction*, testicular atrophy*, gynaecomastia*, pelvic pain, prostatitis, prostate tenderness, retrograde ejaculation, testicular pain
Disfunzjoni erettili *, atrofija testikulari *, ġinekomastija *, uġigħ pelviku, prostatite, sensittività fil- prostata, ejakulazzjoni retrograda, uġigħ testikulari
Injection site adverse events
Avvenimenti avversi fis- sit tal - injezzjoni
Chills, pyrexia, asthenia, fatigue*, Influenza-like illness
Tkexkix ta ’ bard, deni, astenja, għeja kbira *, mard bħal dak tal - influwenza
Localised oedema
Edima lokalizzata
Weight increased*
Żieda fil- piż *
*Known physiological consequence of testosterone suppression
* Konsegwenza fiżjoloġika magħrufa tat- trażżin tat- testosterone
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.
Tibdil fil- parametri tal- laboratorju It- tibdil fil- valuri tal- laboratorju li kien osservat matul sena ta ’ kura kien fl- istess medda għal degarelix u agonist ta ’ GnRH (leuprorelin) li ntuża bħala komparatur.
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.
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.
Marked decrease in haematological values, hematocrit (≤ 0.37) and hemoglobin (≤ 115 g/ l) were seen in 40% and 13-15%, respectively, of patients with normal values prior to treatment, following treatment with both medicinal products.
Tnaqqis b’ mod ċar fil- valuri ematoloġiċi, fl- ematokrit (≤0. 37) u fl- emoglobina (≤115 g/ l), kienu osservati f’ 40% u fi 13 - 15%, rispettivament, tal- pazjenti li kellhom valuri normali qabel il- kura, wara li ngħataw kura biż - żewġ prodotti mediċinali.
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.
Mhux magħruf sa liema grad dan it- tnaqqis fil- valuri ematoloġiċi kien ikkawżat mill- kanċer tal- prostata nnifsu u sa liema grad kien konsegwenza tat- terapija tal- privazzjoni tal- androgen.
5 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.
Valuri anormali b’ mod ċar ta ’ potassium (≥5. 8 mmol/ l), krejatinina (≥177 μmol/ l) u BUN (≥10. 7 mmol/ l) f’ pazjenti b’ valuri normali qabel il- kura, kienu osservati f’ 6%, 2% u 15% tal - pazjenti kkurati b’ degarelix, u fi 3%, 2% u 14% tal- pazjenti kkurati b’ leuprorelin, rispettivament.
Changes in ECG measurements Changes in ECG measurements seen during one year of treatment were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator.
Tibdil fil- kejl tal- ECG It- tibdil fil- kejl tal- ECG li deher matul sena ta ’ kura kien fl- istess medda għal degarelix u agonist ta ’ GnRH (leuprorelin) li ntuża bħala komparatur.
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.
Tlieta (< 1%) minn 409 pazjenti fil- grupp ta ’ degarelix u erbgħa (2%) minn 201 pazjent fil- grupp ta ’ 7. 5 mg leuprorelin, kellhom QTcF ta ’ ≥ 500 msek.
From baseline to end of study the median change in QTcF for degarelix was 12.0 msec and for leuprorelin was 16.7 msec.
Mil - linja bażi sat- tmiem tal- istudju, il- medjan tal- bidla fil- QTcF għal degarelix kien ta ’ 12. 0 msek u għal leuprorelin kien ta ’ 16. 7 msek.
There is no clinical experience with the effects of an acute overdose with degarelix.
M’ hemm l- ebda esperjenza klinika bl- effetti ta ’ doża eċċessiva akuta b’ degarelix.
In the event of an overdose the patient should be monitored and appropriate supportive treatment should be given, if considered necessary.
Fil- każ ta ’ doża eċċessiva, il- pazjent għandu jiġi mmonitorjat u għandha tingħata kura adattata ta ’ appoġġ, jekk dan ikun ikkunsidrat bħala meħtieġ.
Other hormone antagonists and related agents, ATC code:
Antagonisti oħrajn tal- ormoni u sustanzi relatati, Kodiċi ATC:
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.
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.
Prostatic carcinoma is known to be androgen sensitive and responds to treatment that removes the source of androgen.
Il- karċinoma prostatika hi magħrufa li hi sensittiva għall - androgen u tirrispondi għall- kura li tneħħi s- sors tal- androgen.
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.
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.
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.
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.
The plasma concentration of dihydrotestosterone (DHT) decreases in a similar manner to testosterone.
Il - konċentrazzjoni fil- plażma ta ’ dihydrotestosterone (DHT) tonqos b’ mod jixbaħ lit- testosterone.
Degarelix is effective in achieving and maintaining testosterone suppression well below medical castration level of 0.5 ng/ ml.
Degarelix hu effettiv fil- kisba u l- manteniment tat- trażżin tat- testosterone taħt sew tal- livell tal - kastrazzjoni medika ta ’ 0. 5 ng/ ml.
Maintenance monthly dosing of 80 mg resulted in sustained testosterone suppression in 97% of patients for at least one year.
Id- dożaġġ tal- manteniment ta ’ kull xahar ta ’ 80 mg irriżulta fi trażżin sostnut tat- testosterone f’ 97% tal- pazjenti għal mill- inqas sena.
Median testosterone levels after one year of treatment were 0.087 ng/ ml (interquartile range 0.06-0.15) N=167.
Il- medjan tal- livelli tat - testosterone wara sena ta ’ kura kien ta ’ 0. 087 ng/ ml (medda interquartile minn 0. 06- 0. 15) N=167.
Results of the confirmatory Phase III study The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
6 Riżultati tal- istudju konfermatorju ta ’ Fażi III L- effikaċja u s- sigurtà ta ’ degarelix kienu evalwati fi studju open- label, multiċentriku, randomised, ikkontrollat minn komparatur attiv, u f’ grupp parallel.
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.
L- istudju investiga l- effikaċja u s- sigurtà ta ’ żewġ korsijiet differenti ta ’ dożaġġ ta ’ degarelix mogħtija kull xahar, b’ doża tal- bidu ta ’ 240 mg (40 mg/ ml) 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.
In total 620 patients were randomised to one of the three treatment groups, of which 504 (81%) patients completed the study.
B’ kollox 620 pazjent kienu randomised għal wieħed mit- tliet gruppi tal- kura, li minnhom 504 (81%) pazjenti temmew l- istudju.
In the degarelix 240/ 80 mg treatment group 41 (20%) patients discontinued the study, as compared to 32 (16%) patients in the leuprorelin group.
Fil- grupp tal - kura ta ’ degarelix 240/ 80 mg, 41 (20%) pazjent ma komplewx bl- istudju, meta mqabbel ma ’ 32 (16%) pazjent fil- grupp ta ’ leuprorelin.
Of the 610 patients treated • 31% had localised prostate cancer • 29% had locally advanced prostate cancer • 20% had metastatic prostate cancer • 7% had an unknown metastatic status • 13% had previous curative intent surgery or radiation and a rising PSA
Mis- 610 pazjenti li kienu kkurati • 31% kellhom kanċer tal- prostata lokalizzat • 29% kellhom kanċer tal- prostata lokalment avvanzat • 20% kellhom kanċer tal- prostata metastatiku • 7% kellhom stat metastatiku mhux magħruf • 13% kellhom operazzjoni fil- passat li l- għan tagħha kienet il- kura, jew radjazzjoni u PSA li qed jiżdied
6 Baseline demographics were similar between the arms.
Id- demografija fil- linja bażi kienet simili bejn il- fergħat tal- istudju.
The median age was 74 years (range 47 to 98 years).
Il- medjan tal- età kienet ta ’ 74 sena (medda minn 47 sa 98 sena).
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.
L- għan primarju kien biex jintwera li degarelix hu effettiv fir- rigward tal - kisba u l- manteniment tat- trażżin tat- testosterone taħt livell ta ’ 0. 5 ng/ ml, matul it- 12- il xahar tal- kura.
The lowest effective maintenance dose of 80 mg degarelix was chosen.
L- inqas doża effettiva tal- manteniment ta ’ 80 mg ta ’ degarelix kienet magħżula.
Attainment of serum testosterone (T) ≤ 0.5 ng/ ml FIRMAGON is effective in achieving fast testosterone suppression, see Table 2.
Il- kisba ta ’ testosterone fis- serum ta ’ ≤0. 5 ng/ ml FIRMAGON hu effettiv fil- kisba ta ’ trażżin mgħaġġel tat- testosterone, ara Tabella 2.
Percentage of patients attaining T≤ 0.5 ng/ ml after start of treatment.
Perċentwali ta ’ pazjenti li kisbu T≤0. 5 ng/ ml wara l- bidu tal- kura.
Time Day 1 Day 3 Day 7 Day 14 Day 28
Ħin Jum 1 Jum 3 Jum 7 Jum 14 Jum 28
Leuprorelin 7.5 mg 0% 0% 1% 18% 100%
Leuprorelin 7. 5 mg 0% 0% 1% 18% 100%
Avoidance of testosterone surge Surge was defined as testosterone exceeding baseline by ≥ 15% within the first 2 weeks.
L- ilqugħ kontra żieda f’ daqqa tat- testosterone Iż- żieda f’ daqqa kienet definita bħala testosterone li jaqbeż il- linja bażi bi ≥15% fl- ewwel ġimagħtejn.
None of the degarelix-treated patients experienced a testosterone surge; there was an average decrease of 94% in testosterone at day 3.
Ħadd mill- pazjenti kkurati b’ degarelix ma kellu żieda f’ daqqa fit- testosterone; kien hemm tnaqqis medju ta ’ 94% fit- testosterone f’ jum 3.
Most of the leuprorelin-treated patients experienced testosterone surge; there was an average increase of 65% in testosterone at day 3.
Il- biċċa l- kbira tal- pazjenti kkurati b’ leuprorelin kellhom żieda f’ daqqa fit- testosterone; kien hemm żieda medja ta ’ 65% fit- testosterone f’ jum 3.
This difference was statistically significant (p < 0.001).
Din id- differenza kienet statistikament sinifikanti (p < 0. 001).
Figure 1:
7 Figura 1:
Percentage change in testosterone from baseline by treatment group until day 28 (median with interquartile ranges).
Bidla perċentwali fit- testosterone mil- linja bażi skont il- grupp tal- kura sa jum 28 (medjan bil- meded interquartile).
The primary end-point in the study was testosterone suppression rates after one year of treatment with degarelix or leuprorelin.
Il- punt aħħari primarju fl- istudju kien ir- rati tat- trażżin tat- testosterone wara sena ta ’ kura b’ degarelix jew b’ leuprorelin.
The clinical benefit for degarelix compared to leuprorelin plus anti-androgen in the initial phase of treatment has not been demonstrated.
Il- benefiċċju kliniku għal degarelix meta mqabbel ma ’ leuprorelin flimkien ma ’ anti- androgen fil- fażi inizjali tal- kura ma ntweriex.
7 Long-term effect Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ ml.
Effett fit- tul Rispons li rnexxa fl- istudju kien definit bħala l- kisba ta ’ kastrazzjoni medika f’ jum 28 u l - manteniment sa jum 364 fejn lanqas waħda mill- konċentrazzjoni tat- testosterone ma kienet akbar minn 0. 5 ng/ ml.
Cumulative probability of testosterone ≤ 0.5 ng/ ml from Day 28 to Day 364.
Probabbiltà kumulattiva ta ’ testosterone ≤0. 5 ng/ ml minn Jum 28 sa Jum 364.
Leuprorelin 7.5 mg N=201
Leuprorelin 7. 5 mg N=201
No. of responders
Nru. ta ’ dawk li rrispondew Rata ta ’ Rispons (intervalli tal- kunfidenza) * * Stimi Kaplan Meier fil- grupp
202
202 97. 2% (93. 5; 98. 8%)
194
194 96. 4% (92. 5; 98. 2%)
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.
Il- kisba ta ’ tnaqqis tal- antiġen speċifiku għall- prostata (PSA) 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.
The median PSA in the study at baseline was: • for the degarelix 240/ 80 mg treatment group 19.8 ng/ ml (interquartile range:
Il- medjan tal- PSA fl- istudju fil- linja bażi kien: • 19. 8 ng/ ml (medda interquartile:
P25 9.4 ng/ ml, P75 46.4 ng/ ml) • for the leuprorelin 7.5 mg treatment group 17.4 ng/ ml (interquartile range:
P25 9. 4 ng/ ml, P75 46. 4 ng/ ml) għall- grupp tal- kura b’ degarelix 240/ 80 mg • 17. 4 ng/ ml (medda interquartile:
P25 8.4 ng/ ml, P75 56.5 ng/ ml)
P25 8. 4 ng/ ml, P75 56. 5 ng/ ml) għall- grupp tal- kura ta ’ leuprorelin 7. 5 mg
Percentage change in PSA from baseline by treatment group until day 56 (median with interquartile ranges).
Bidla perċentwali fil- PSA mil- linja bażi skont il- grupp tal- kura sa Jum 56 (medjan bil- meded interquartile).
This difference was statistically significant (p < 0.001) for the pre-specified analysis at day 14 and day 28.
Din id- differenza kienet statistikament sinifikanti (p < 0. 001) għall- analiżi pre- speċifika f’ jum 14 u jum 28.
8 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.
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.
From day 56 to day 364 there were no significant differences between degarelix and the comparator in the percentage change from baseline.
Minn jum 56 sa jum 364 ma kien hemm l- ebda differenzi sinifikanti bejn degarelix u l- komparatur fil - bidla perċentwali mil- linja bażi.
In the confirmatory study comparing FIRMAGON to leuprorelin periodic electrocardiograms were performed.
Fi studju konfermatorju li qabbel FIRMAGON ma ’ leuprorelin, saru elettrokardjogrammi perjodiċi.
Both therapies showed QT/ QTc intervals exceeding 450 msec in approximately 20% of the patients.
Iż- żewġ terapiji wrew intervalli QT/ QTcs li kienu jaqbżu 450 msek f’ madwar 20% tal- pazjenti.
From baseline to end of study the median change for FIRMAGON was 12.0 msec and for leuprorelin it was 16.7 msec.
Mil - linja bażi sat- tmiem tal- istudju, il- medjan tal- bidla għal FIRMAGON kien ta ’ 12. 0 msek u għal leuprorelin kien ta ’ 16. 7 msek.
Anti-degarelix antibody development has been observed in 10% of patients after treatment with FIRMAGON for one year.
L- iżvilupp tal- antikorp antidegarelix kien osservat f’ 10% tal- pazjenti wara l- kura b’ FIRMAGON għal sena.
There is no indication that the efficacy or safety of FIRMAGON treatment is affected by antibody formation after one year of treatment.
M’ hemm l- ebda indikazzjoni li l- effikaċja jew is- sigurtà tal- kura b’ FIRMAGON tkun affettwata mill- formazzjoni tal- antikorp wara sena ta ’ kura.
Efficacy and safety data in relation to antibody development beyond one year is not available.
Id- dejta dwar l- effikaċja u s- sigurtà fir- rigward tal - iżvilupp tal- antikorpi wara iżjed minn sena mhuwiex disponibbli.
Absorption 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 (61.0-71.0) ng/ ml and occurred at tmax at 40 (37-42) hours.
Assorbiment Wara l- għoti taħt il- ġilda ta ’ 240 mg ta ’ degarelix f’ konċentrazzjoni ta ’ 40 mg/ ml lil pazjenti b’ kanċer tal- prostata fl- istudju importanti ħafna CS21, l- AUC0- 28 jum kienet ta ’ 635 (602- 668) kuljum* ng/ ml, is - Cmax kienet ta ’ 66. 0 (61. 0- 71. 0) ng/ ml u seħħet f’ tmax f’ 40 (37- 42) siegħa.
Mean trough values were approximately 11-12 ng/ ml after the starting dose and 11-16 ng/ ml after maintenance dosing of 80 mg at a concentration of 20 mg/ ml.
Il- medja tal- valuri minimi kienu ta ’ madwar 11- 12 ng/ ml wara d- doża tal- bidu, u 11- 16 ng/ ml wara d- doża tal- manteniment ta ’ 80 mg f’ konċentrazzjoni ta ’ 20 mg/ ml.
Degarelix is eliminated in a biphasic fashion, with a median terminal half- life (t½) of approximately 43 days for the starting dose or 28 days for the maintenance dose, as estimated based on population pharmacokinetics modelling.
Degarelix jiġi eliminat b’ mod bifażiku, bil- medjan tal- half- life (t½) terminali ta ’ madwar 43 jum għad- doża tal- bidu jew 28 jum għad- doża tal- manteniment, kif stmat ibbażat fuq l- immudellar tal- farmakokinetika tal- popolazzjoni.
The long half-life after subcutaneous administration is a consequence of a very slow release of degarelix from the depot formed at the injection site(s).
Il- half- life twila wara l- għoti taħt il - ġilda hi konsegwenza tat- tnixxija bil- mod ħafna ta ’ degarelix mid- depot li jifforma fis- sit( i) tal - injezzjoni.
The pharmacokinetic behavior of the medicinal product is influenced by its concentration in the solution for injection.
L- imġiba farmakokinetika tal- prodott mediċinali hi influwenzata mill- konċentrazzjoni tagħha fis- soluzzjoni għall- injezzjoni.
Thus, Cmax and bioavailability tend to decrease with increasing dose concentration while the half-life is increased.
Għaldaqstant, is- Cmax u l- bijodisponibilità għandhom tendenza li
Therefore, no other dose concentrations than the recommended should be used.
9 jonqsu maż- żieda fil- konċentrazzjoni tad- doża, filwaqt li l- half- life tiżdied.
Distribution The distribution volume in healthy elderly men is approximately 1 l/ kg.
Distribuzzjoni Il- volum tad- distribuzzjoni f’ irġiel anzjani b’ saħħithom hu ta ’ madwar 1 l/ kg.
Plasma protein binding is estimated to be approximately 90%.
It- twaħħil mal- proteini fil- plażma hu stmat li hu ta ’ madwar 90%.
Metabolism 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.
Metaboliżmu Degarelix hu suġġett għal degradazzjoni peptidika komuni matul il- passaġġ mis- sistema epatobiljari u jitneħħa primarjament bħala bċejjeċ tal- peptide fl- ippurgar.
No significant metabolites were detected in plasma samples after subcutaneous administration.
L- ebda metaboliti sinifikanti ma kienu osservati fil- kampjuni tal- plażma wara l- għoti taħt il- ġilda.
In vitro studies have shown that degarelix is not a substrate for the human CYP450 system.
Studji in vitro wrew li degarelix mhuwiex substrat għas- sistema CYP450 umana.
Excretion 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.
Tneħħija 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.
The clearance of degarelix when administered as single intravenous doses (0.864-49.4 µg/ kg) in healthy elderly men was found to be 35-50 ml/ h/ kg.
Instab li t- tneħħija ta ’ degarelix, meta mogħti bħala dożi waħidhom ġol- vini (0. 864- 49. 4 µg/ kg) f’ irġiel anzjani b’ saħħithom, kienet ta ’ 35- 50 ml/ siegħa/ kg.
Patients with renal impairment No pharmacokinetic studies in renally impaired patients have been conducted.
Pazjenti b’ indeboliment renali Ma saru l- ebda studji farmakokinetiċi f’ pazjenti li kellhom indeboliment renali.
Only about 20-30% of a given dose of degarelix is excreted unchanged by the kidneys.
Minn 20- 30% biss tad - doża mogħtija ta ’ degarelix titneħħa mhux mibdula mill- kliewi.
Data on patients with severe renal impairment is scarce and caution is therefore warranted in this patient population.
Analiżi dwar il- farmakokinetika tal - popolazzjoni tad- dejta minn studju konfermatorju ta ’ Fażi III wriet li t- tneħħija ta ’ degarelix f’ pazjenti b’ indeboliment renali minn ħafif sa moderat titnaqqas b’ madwar 23%; għalhekk, l- aġġustament fid - doża f’ pazjenti b’ indeboliment renali ħafif jew moderat mhuwiex rakkomandat.
Patients with hepatic impairment
Dejta fuq pazjenti b’ indeboliment renali sever hi skarsa u għalhekk il- kawtela hija meħtieġa f’ din il- popolazzjoni ta ’ pazjenti.
9 Degarelix has been investigated in a pharmacokinetic study in patients with mild to moderate hepatic impairment.
Pazjenti b’ indeboliment epatiku Degarelix kien investigat fi studju farmakokinetiku f’ pazjenti b’ indeboliment epatiku li kien minn ħafif sa moderat.
No signs of increased exposure in the hepatically impaired subjects were observed compared to healthy subjects.
Ma kienu osservati l- ebda sinjali ta ’ żieda fl- esponiment f’ persuni li kellhom indeboliment epatiku meta mqabbel ma ’ persuni b’ saħħithom.
Dose adjustment is not necessary in patients with mild or moderate hepatic impairment.
M’ hemmx bżonn ta ’ aġġustament fid - dożaġġ għal pazjenti li għandhom indeboliment epatiku ħafif jew moderat.
Patients with severe hepatic dysfunction have not been studied and caution is therefore warranted in this group.
Pazjenti li jkollhom disfunzjoni epatika severa ma kinux studjati u għalhekk hu rakkomandat li tintuża l- kawtela f’ dan il - grupp.
Animal reproduction studies showed that degarelix caused infertility in male animals.
Studji dwar ir- riproduzzjoni fl- annimali wrew li degarelix ikkawża l- infertilità f’ annimali rġiel.
This is due to the pharmacological effect; and the effect was reversible.
Dan hu minħabba l- effett farmakoloġiku; u l- effett kien riversibbli.
In female reproduction toxicity studies degarelix revealed findings expected from the pharmacological properties.
Fi studji dwar it- tossiċità tar- riproduzzjoni fin- nisa, degarelix żvela sejbiet mistennija mit- tagħrif farmakoloġiku.
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.
Hu kkawża titwil, li kien dipendenti fuq id- dożaġġ, taż- żmien għat- tgħammir u t- tqala, 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.
Preclinical studies on safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential revealed no special hazard for humans.
Studji mhux kliniċi ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il - ġeni, u riskju ta ’ kanċer, ma turi l- ebda periklu speċjali għall- bnedmin.
Both in vitro and in vivo studies showed no signs of QT prolongation.
Kemm studji in vitro kif ukoll in vivo ma wrew l- ebda sinjali ta ’ titwil tal- QT.
No target organ toxicity was observed from acute, subacute and chronic toxicity studies in rats and monkeys following subcutaneous administration of degarelix.
L- ebda tossiċità tal- organu fil- mira ma kienet osservata minn studji dwar tossiċità akuta, sottoakuta u kronika fuq firien u xadini wara l- għoti taħt il- ġilda ta ’ degarelix.
Drug-related local irritation was noted in animals when degarelix was administered subcutaneously in high doses.
Irritazzjoni lokali marbuta mal - mediċina kienet osservata fl- annimali meta degarelix ingħata taħt il- ġilda f’ dożi qawwija.
Powder Mannitol (E421)
Trab Mannitol (E421)
Solvent Water for injections
Solvent Ilma għall- injezzjonijiet
After reconstitution Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
Wara r- rikostituzzjoni L- istabbiltà kimika u fiżika waqt l- użu ntweriet li ddum sagħtejn f’ temperatura ta ’ 25ºC.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Mill- aspett mikrobijoloġiku, ħlief jekk il- metodu tar- rikostituzzjoni jipprekludi r- riskju ta ’ kontaminazzjoni mikrobjali, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Jekk ma jintużax immedjatament, iż- żmien tal - ħażna u l- kundizzjonijiet waqt l- użu huma r- responsabbiltà ta ’ min jagħmel użu minnu.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall- kundizzjonijiet tal- ħażna tal- prodott mediċinali rikostitwit, ara sezzjoni 6. 3.
10 Vials of glass Type I with bromobutyl rubber stopper and aluminium flip-off seal.
Kunjetti tal- ħġieġ tat- Tip I, b’ tapp tal- lastku bromobutyl u siġill tal- aluminju li jinfetaħ b’ saba ’ wieħed.
1 vial containing 80 mg powder for solution for injection 1 vial containing 6 ml solvent 1 syringe (5 ml) 1 reconstitution needle (21G 0.8 x 50 mm) 1 injection needle (27G 0.4 x 25 mm)
Kunjett wieħed li fih 80 mg trab għal soluzzjoni għall- injezzjoni Kunjett wieħed li fih 6 ml ta ’ solvent Siringa waħda (5 ml) Labra waħda tar- rikostituzzjoni (21G 0. 8 x 50 mm) Labra waħda tal- injezzjoni (27G 0. 4 x 25 mm)
No special requirements for disposal.
M’ hemm bzonn li jittiehdu l- ebda htigijiet specjali meta jintrema.
Instructions for use:
Struzzjonijiet għall- użu:
The instructions for reconstitution must be followed carefully.
L- istruzzjonijiet għar- rikostituzzjoni għandhom jiġu segwiti b’ kawtela.
Administration of other concentrations is not recommended because the gel depot formation is influenced by the concentration.
L- għoti ta ’ konċentrazzjonijiet oħrajn mhuwiex rakkomandat minħabba li l- formazzjoni tal- ġell depot jiġi influwenzat mill- konċentrazzjoni.
The reconstituted solution should be a clear liquid, free of undissolved matter.
Is- soluzzjoni rikostitwita għandha tkun likwidu ċar, li ma jkollux materjal mhux maħlul.
NOTE: • THE VIALS SHOULD BE KEPT VERTICAL AT ALL TIMES • THE VIALS SHOULD NOT BE SHAKEN
NOTA: • IL- KUNJETTI GĦANDHOM JINŻAMMU F’ POŻIZZJONI VERTIKALI L- ĦIN KOLLU • IL- KUNJETTI M’ GĦANDHOMX JITĦAWDU
The pack contains 1 set of powder and solvent that must be prepared for subcutaneous injection.
Il- pakkett fih sett 1 ta ’ trab u solvent li jridu jiġu ppreparati għal injezzjoni taħt il- ġilda.
Draw up 4.2 ml solvent for injection with the reconstitution needle (green needle, 21G / 0.8 x 50 mm).
Iġbed 4. 2 ml ta ’ solvent għall- injezzjoni bil- labra tar- rikostituzzjoni (labra ħadra, 21G / 0. 8 x 50 mm).
Discard the vial with the remaining solvent.
Armi l- kunjett bis- solvent li jkun fadal.
Inject the solvent slowly into the vial with powder.
Injetta s- solvent bil- mod ġol- kunjett bit- trab.
DO NOT REMOVE THE SYRINGE AND THE NEEDLE, to keep the medicinal product and syringe sterile.
TNEĦĦIX IS - SIRINGA U L- LABRA, biex iżżomm il- prodott mediċinali u s - siringa sterili.
KEEP THE VIAL IN AN UPRIGHT POSITION.
ŻOMM IL- KUNJETT F’ POŻIZZJONI VERTIKALI.
Swirl very gently until the liquid looks clear and without undissolved powder or particles.
Dawwar il- likwidu bil- mod ħafna sakemm ikun jidher ċar mingħajr trab mhux maħlul jew frak.
In case the powder adheres to the vial over the liquid surface, the vial can be tilted slightly.
F’ każ li t- trab jeħel mal- kunjett ’ il fuq mill- wiċċ tal- likwidu, il- kunjett jista ’ jitmejjel ftit.
AVOID SHAKING TO PREVENT FOAM FORMATION.
EVITA LI TĦAWDU BIEX MA TIFFURMAX RAGĦWA.
A ring of small air bubbles on the surface of the liquid is acceptable.
Ċirku ta ’ bżieżaq żgħar tal- arja fuq il- wiċċ tal- likwidu hu aċċettabbli.
The reconstitution procedure may take, in some cases, up to 15 minutes, but usually takes a few minutes.
Il- proċedura tar- rikostituzzjoni tista ’ tieħu, f’ xi każijiet, sa 15- il minuta, iżda normalment tieħu ftit minuti.
Tilt the vial slightly and keep the needle in the lowest part of the vial.
Mejjel ftit il- kunjett u żomm il- labra fl- iktar parti l- isfel tal- kunjett.
Withdraw 4.0 ml of the solution without turning the vial upside down.
Iġbed 4. 0 ml mis- soluzzjoni mingħajr ma taqleb il- kunjett ta ’ taħt fuq.
5. Exchange the green needle with the white needle for deep subcutaneous injection (27G / 0.4 x 25 mm).
Ibdel il- labra l- ħadra mal- labra l- bajda li qegħda għal injezzjoni profonda taħt il- ġilda (27G / 0. 4 x 25 mm).
Remove any air bubbles.
Neħħi kwalunkwe bżieżaq tal- arja.
Grasp the skin of the abdomen, elevate the subcutaneous tissue.
Aqbad il- ġilda tal- addome, u erfa ’ t- tessut ta ’ taħt il- ġilda.
Perform a profound subcutaneous injection.
Agħti injezzjoni profonda taħt il- ġilda.
To do so, insert the needle deeply at an angle of not less than 45 degrees.
Biex tagħmel hekk, daħħal il- labra fil- fond f’ angolu ta ’ mhux inqas minn 45 grad.
Do not inject directly into a vein.
Tinjettax direttament ġo vina.
Gently pull back the plunger to check if blood is aspirated.
Iġbed lura l- planġer bil- mod biex tiċċekkja jekk id- demm jinġibidx.
If blood appears in the syringe, the medicinal product can no longer be used.
Jekk id- demm jidher fis- siringa, il- prodott mediċinali ma jistax jintuża aktar.
Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).
Waqqaf il- proċedura u armi s- siringa u l- labra (irrikostitwixxi doża ġdida għall- pazjent).
Please be aware:
Jekk jogħġbok innota:
• 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.
• L- ebda injezzjonijiet m’ għandhom jingħataw f’ żoni fejn il- pazjent ser ikun espost għal pressjoni, eż. madwar il- qadd jew fejn jintlibes iċ- ċinturin jew qrib il- kustilji.
* Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC.
* L- istabbiltà kimika u fiżika waqt l- użu ntweriet li ddum sagħtejn f’ temperatura ta ’ 25ºC.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Mill - aspett mikrobijoloġiku, ħlief jekk il- metodu tar- rikostituzzjoni jipprekludi r- riskju ta ’
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna u l- kundizzjonijiet waqt l- użu huma r- responsabbiltà ta ’ min qed jagħmel użu minnu.
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 DK-2300 Copenhagen S Denmark Tel: +45 88 33 88 34
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 DK- 2300 Copenhagen S Id- Danimarka Tel: +45 88 33 88 34
{DD/ MM/ YYYY}
{JJ/ XX/ SSSS}
FIRMAGON 120 mg powder and solvent for solution for injection
FIRMAGON 120 mg trab u solvent għal soluzzjoni għall- injezzjoni
Each vial contains 120 mg degarelix (as acetate).
Kull kunjett fih 120 mg ta ’ degarelix (bħala acetate).
After reconstitution, each ml solution contains 40 mg of degarelix.
Wara r- rikostituzzjoni, kull millilitru ta ’ soluzzjoni jkun fih 40 mg ta ’ degarelix.
Subcutaneous use ONLY, not to be administered intravenously.
14 Użu għal taħt il- ġilda BISS, m’ għandux jingħata ġol- vina.
13 Intramuscular administration is not recommended as it has not been studied.
L- għoti ġol- muskoli mhuwiex rakkomandat għax għadu ma kienx studjat.
14 A reduction in glucose tolerance has been observed in men who have had orchiectomy or who have been treated with a GnRH agonist.
15 Tolleranza għaz- zokkor Tnaqqis fit- tolleranza għaz- zokkor kien osservat f’ irġiel li kellhom orkijektomija jew li kienu kkurati b’ agonist ta ’ GnRH.
16 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.
Valuri anormali b’ mod ċar ta ’ potassium (≥5. 8 mmol/ l), krejatinina (≥177 μmol/ l) u BUN (≥10. 7 mmol/ l) f’ pazjenti b’ valuri normali qabel il- kura, kienu osservati f’ 6%, 2% u 15% tal - pazjenti kkurati b’ degarelix, u fi 3%, 2% u 14% tal- pazjenti kkurati b’ leuprorelin, rispettivament.
Results of the confirmatory Phase III study The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
18 Riżultati tal- istudju konfermatorju ta ’ Fażi III L- effikaċja u s- sigurtà ta ’ degarelix kienu evalwati fi studju open- label, multiċentriku, randomised, ikkontrollat minn komparatur attiv, u f’ grupp parallel.
17 Baseline demographics were similar between the arms.
Id- demografija fil- linja bażi kienet simili bejn il- fergħat tal- istudju.
18 Long-term effect Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ ml.
Effett fit- tul Rispons li rnexxa fl- istudju kien definit bħala l- kisba ta ’ kastrazzjoni medika f’ jum 28 u l - manteniment sa jum 364 fejn lanqas waħda mill- konċentrazzjoni tat- testosterone ma kienet akbar minn 0. 5 ng/ ml.
Figure 2:
20 Figura 2:
19 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.
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.
Therefore, no other dose concentrations than the recommended should be used.
21 jonqsu maż- żieda fil- konċentrazzjoni tad- doża, filwaqt li l- half- life tiżdied.
20 Degarelix has been investigated in a pharmacokinetic study in patients with mild to moderate hepatic impairment.
Pazjenti b’ indeboliment epatiku Degarelix kien investigat fi studju farmakokinetiku f’ pazjenti b’ indeboliment epatiku li kien minn ħafif sa moderat.
21 Vials of glass Type I with bromobutyl rubber stopper and aluminium flip-off seal.
Kunjetti tal- ħġieġ tat- Tip I, b’ tapp tal- lastku bromobutyl u siġill tal- aluminju li jinfetaħ b’ saba ’ wieħed.
2 vials containing 120 mg powder for solution for injection 2 vials containing 6 ml solvent 2 syringes (5 ml) 2 reconstitution needles (21G 0.8 x 50 mm) 2 injection needles (27G 0.4 x 25 mm)
2 kunjetti li fihom 120 mg trab għal soluzzjoni għall- injezzjoni 2 kunjetti li fihom 6 ml ta ’ solvent 2 siringi (5 ml) 2 labar tar- rikostituzzjoni (21G 0. 8 x 50 mm) 2 labar tal- injezzjoni (27G 0. 4 x 25 mm)
The pack contains 2 sets of powder and solvent that must be prepared for subcutaneous injection.
23 Il- pakkett fih 2 settijiet ta ’ trab u solvent li jridu jiġu ppreparati għal injezzjoni taħt il- ġilda.
Hence, the instructions here below need to be repeated a second time.
Għaldaqstant, l- istruzzjonijiet t’ hawn taħt jeħtieġ li jiġu rripetuti għat- tieni darba.
Draw up 3.0 ml solvent for injection with the reconstitution needle (green needle, 21G / 0.8 x 50 mm).
Iġbed 3. 0 ml ta ’ solvent għall- injezzjoni bil- labra tar- rikostituzzjoni (labra ħadra, 21G / 0. 8 x 50 mm).
Withdraw 3.0 ml of the solution without turning the vial upside down.
Iġbed 3. 0 ml mis- soluzzjoni mingħajr ma taqleb il- kunjett ta ’ taħt fuq.
22 5. Exchange the green needle with the white needle for deep subcutaneous injection (27G / 0.4 x 25 mm).
5. Ibdel il- labra l- ħadra mal- labra l- bajda li qegħda għal injezzjoni profonda taħt il- ġilda (27G / 0. 4 x 25 mm).
Inject 3.0 ml of FIRMAGON 120 mg immediately after reconstitution. *
Injetta 3. 0 ml ta ’ FIRMAGON 120 mg immedjatament wara r- rikostituzzjoni. *
Repeat the reconstitution procedure for the second dose.
Irrepeti l- proċedura tar- rikostituzzjoni għat- tieni doża.
Choose a different injection site and inject 3.0 ml.
Agħżel post differenti fejn tagħti l - injezzjoni u injetta 3. 0 ml.
Please be aware:
24 Jekk jogħġbok innota:
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Mill - aspett mikrobijoloġiku, ħlief jekk il- metodu tar- rikostituzzjoni jipprekludi r- riskju ta ’ kontaminazzjoni mikrobjali, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna u l- kundizzjonijiet waqt l- użu huma r- responsabbiltà ta ’ min jagħmel użu minnu.
Name and address of the manufacturer responsible for batch release Ferring GmbH Wittland 11 D-24109 Kiel Germany
Ferring GmbH Wittland 11 D- 24109 Kiel Il- Ġermanja
• Posology • Instructions for administration • Information on gel depot formation and possible injections site reactions • Information on the identified and potential risks
• Pożoloġija • Struzzjonijiet għall- għoti • Informazzjoni dwar il- formazzjoni ta ’ ġell depot u reazzjonijiet possibbli fis- sit tal- injezzjonijiet • Informazzjoni dwar ir- riskji identifikati u potenzjali
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 2. 0 ippreżentata f’ Modulu 1. 8. 1. tal- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jibda jinbiegħ.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju L- MAH irid ikun obbligat li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 4. 2 tal- Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2. tal- Applikazzjoni tal- Awtorizzazzjoni għat - Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
27 • Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir - riskju. • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
25 ANNEX III
28 ANNESS III
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR FIRMAGON 80 mg powder and solvent for solution for injection
KARTUNA GĦAL FIRMAGON 80 mg trab u solvent għal soluzzjoni għall- injezzjoni
FIRMAGON 80 mg powder and solvent for solution for injection degarelix
FIRMAGON 80 mg trab u solvent għal soluzzjoni għall- injezzjoni degarelix
After reconstitution each ml of the solution contains 20 mg degarelix.
Wara r- rikostituzzjoni, kull 1 ml tas- soluzzjoni jkun fih 20 mg ta ’ degarelix.
Mannitol (E421), water for injections
Mannitol (E421), ilma għall- injezzjonijiet
Powder and solvent for solution for injection 1 vial with 80 mg degarelix (powder) 1 vial with 6 ml solvent 1 syringe 1 reconstitution needle 1 injection needle
Trab u solvent għal soluzzjoni għall- injezzjoni 1 kunjett bi 80 mg ta ’ degarelix (trab) 1 kunjett b’ 6 ml ta ’ solvent 1 siringa 1 labra tar- rikostituzzjoni 1 labra tal- injezzjoni
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 2300 Copenhagen S Denmark +45 88 33 88 34
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 2300 Copenhagen S Id- Danimarka +45 88 33 88 34
29 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL FOR FIRMAGON 80 mg powder for solution for injection
KUNJETT GĦAL FIRMAGON 80 mg trab għal soluzzjoni għall- injezzjoni
FIRMAGON 80 mg powder for injection degarelix SC use only
FIRMAGON 80 mg trab għall- injezzjoni degarelix Użu għal taħt il- ġilda (SC) biss
BN
Lott
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR FIRMAGON 120 mg powder and solvent for solution for injection
KARTUNA GĦAL FIRMAGON 120 mg trab u solvent għal soluzzjoni għall- injezzjoni
FIRMAGON 120 mg powder and solvent for solution for injection degarelix
FIRMAGON 120 mg trab u solvent għal soluzzjoni għall- injezzjoni degarelix
After reconstitution each ml of the solution contains 40 mg degarelix.
Wara r- rikostituzzjoni, kull 1 ml tas- soluzzjoni jkun fih 40 mg ta ’ degarelix.
Powder and solvent for solution for injection 2 vials with 120 mg degarelix (powder) 2 vials with 6 ml solvent 2 syringes 2 reconstitution needles 2 injection needles
Trab u solvent għal soluzzjoni għall- injezzjoni 2 kunjetti b’ 120 mg ta ’ degarelix (trab) 2 kunjetti b’ 6 ml ta ’ solvent 2 siringi 2 labar tar- rikostituzzjoni 2 labar tal- injezzjoni
32 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
35 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL FOR FIRMAGON 120 mg powder for solution for injection
KUNJETT GĦAL FIRMAGON 120 mg trab għal soluzzjoni għall- injezzjoni
FIRMAGON 120 mg powder for injection degarelix SC use only
FIRMAGON 120 mg trab għall- injezzjoni degarelix Użu għal taħt il- ġilda (SC) biss
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL FOR SOLVENT 6 ml water for injections
KUNJETT GĦAS- SOLVENT 6 ml ilma għall- injezzjonijiet
Solvent for FIRMAGON
Solvent għal FIRMAGON
35 PACKAGE LEAFLET:
38 FULJETT TA ’ TAGĦRIF:
FIRMAGON 80 mg powder and solvent for solution for injection Degarelix
FIRMAGON 80 mg trab u solvent għal soluzzjoni għall- injezzjoni Degarelix
− Keep this leaflet.
– Żomm dan il- fuljett.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. – Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek.
What FIRMAGON is and what it is used for 2.
X’ inhu FIRMAGON u għalxiex jintuża 2.
Before you use FIRMAGON 3.
Qabel ma tuża FIRMAGON 3.
How to use FIRMAGON 4.
Kif għandek tuża FIRMAGON 4.
How to store FIRMAGON 6.
Kif taħżen FIRMAGON 6.
WHAT FIRMAGON IS AND WHAT IT IS USED FOR
X’ INHU FIRMAGON U GĦALXIEX JINTUŻA
FIRMAGON contains degarelix.
FIRMAGON fih degarelix.
Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer.
Degarelix hu imblukkatur sintetiku tal- ormoni li jintuża fil- kura ta ’ kanċer tal- prostata.
Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its effects.
Degarelix jimita ormon naturali (ormon li jerħi gonadotrophin, GnRH) u direttament jimblokka l- effetti tiegħu.
By doing so, degarelix immediately reduces the level of the male hormone testosterone that stimulates the prostate cancer.
Billi jagħmel hekk, degarelix immedjatament inaqqas il- livell tal- ormon testosterone fl- irġiel li jistimula l- kanċer tal- prostata.
BEFORE YOU USE FIRMAGON
QABEL MA TUŻA FIRMAGON
Do not use FIRMAGON
Tużax FIRMAGON
− If you are allergic (hypersensitive) to degarelix or any of the other ingredients of FIRMAGON.
− Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal degarelix jew sustanzi oħra ta ’ FIRMAGON.
Take special care with FIRMAGON
Oqgħod attent ħafna b’ FIRMAGON
Please tell your doctor if you have any of the following: − Heart rhythm problems (arrythmia), or are being treated with medicines for this condition.
Jekk jogħġbok għid lit- tabib tiegħek jekk għandek kwalunkwe minn dawn li ġejjin: − Problemi bir- ritmu tal- qalb (arritmija), jew qed tiġi kkurat/ a b’ mediċini għal din il- kundizzjoni.
The risk of heart rhythm problems may be increased when using FIRMAGON. − Diabetes mellitus.
Ir - riskju ta ’ problemi bir- ritmu tal- qalb jista ’ jiżdied meta tuża FIRMAGON. − Dijabete mellitus.
Worsening or onset of diabetes may occur.
L- aggravament jew il- bidu tad- dijabete jista ’ jseħħ.
If you have diabetes, you may have to measure blood glucose more frequently.
Jekk għandek id- dijabete, jista ’ jkollok tkejjel il- livell ta ’ zokkor fid- demm iktar ta ’ spiss.
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, cisapride, moxifloxacine, antipsychotics).
FIRMAGON jista ’ jinterferixxi ma ’ xi mediċini li jintużaw biex jikkuraw problemi fir- ritmu tat- taħbit tal- qalb (eż. quinidine, procainamide, amiodarone u sotalol) jew mediċini oħrajn li jista ’ jkollhom effett fuq ir- ritmu tal- qalb (eż. methadone, cisapride, moxifloxacine, mediċini antipsikotiċi)
Driving and using machines
39 Sewqan u tħaddim ta ’ magni
36 Tiredness and dizziness are common side effects that may impaire your ability to drive and use machines.
L- għeja u l- isturdament huma effetti sekondarji komuni li jistgħu jindebolixxu l- ħila tiegħek li ssuq u tħaddem il- magni.
These side effects may be due to the treatment or effects resulting from the underlying disease.
Dawn l- effetti sekondarji jistgħu jkunu minħabba l- kura jew effetti li jirriżultaw mill- marda nnifisha.
HOW TO USE FIRMAGON
KIF GĦANDEK TUŻA FIRMAGON
This medicine is usually injected by a nurse or a doctor.
Din il- mediċina normalment tiġi injettata minn infermier jew tabib.
The usual starting dose is two injections of 120 mg.
Id- doża normali tal- bidu hi ta ’ żewġ injezzjonijiet ta ’ 120 mg.
After that, you will receive a monthly 80 mg injection.
Wara dik, inti ser tirċievi injezzjoni ta ’ 80 mg kull xahar.
The injected liquid forms a gel from which a continuous release of degarelix takes place over a period of one month.
Il- likwidu injettat jifforma ġell li minnu jkun hemm tnixxija kontinwa ta ’ degarelix fuq perjodu ta ’ xahar.
FIRMAGON must be injected under the skin (subcutaneously) ONLY.
FIRMAGON irid ikun injettat taħt il- ġilda BISS.
FIRMAGON must NOT be given into a blood vessel (intravenously).
FIRMAGON M’ GĦANDUX jingħata ġo vina jew arterja (għal ġol- vina).