qanastek/EMEA-V3 huggingface dataset:
Within each frequency grouping adverse reactions are reported in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza ir- reazzjonijiet avversi huma r- rapportati f’ ordni li tonqos is- serjeta tagħhom.
3 Table 1 Adverse Drug Reactions
Tabella 1 Reazzjonijiet avversi tal- mediċina
Very common
Komuni ħafna Komuni
Common
Mhux komuni
Uncommon
• •
Nervous system disorders Gastrointestinal disorders
Disturbi tas- sistema nervuża
Headache Vomiting, nausea and diarrhoea
Uġigħ ta ’ ras
Renal and urinary disorders
Disturbi urinarji u renali
Urinary tract infections
Infezzjoni fis- sistema ta ’ l- awrina
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u t- tessuti ta ’ taħt il - ġilda
Musculoskeletal and connective tissue disorders
Disturbi muskolu - skeletali u t- tessut konnettiv
Back pain
Uġigħ fid- dahar
Metabolism and nutrition disorders
Disturbi tal - metaboliżmu u n - nutrizzjoni
Hot flushes
Fwawar ta ’ sħana
Venous thromboembolism
Tromboemboliżmu fil- vina
General disorders and administration site conditions
Disturbi ġenerali u l- kundizzjoni tal - post fejn jingħata
Asthenia Injection site reactions including injection site pain and injection site inflammation1
Astenja Reazzjoni fil- post ta ’ l- injezzjoni fosthom uġigħ u infjammazzjoni1
Immune system disorders
Disturbi tas- sistema
Hypersensitivity reactions, including angioedema and urticaria
eċċessiva li tinkludi angjoedema u
Hepatobiliary disorders
Disturbi fil- fwied u fil - marrara
Increased Hepatic Enzymes2
Żieda fl- enzimi epatiċi2
Reproductive system and breast disorders 1
Diturbi fis- sistema
Vaginal moniliasis Leukorrhea Vaginal haemorrhage
• Monilasi Vaġinali • Leukorrhea
injection site reactions pain is transient 7% of patients (1% of injections) when given as a single 5 ml injection.
1 • L- ugieħ tar- reazzjoni fil- post tal- injezzjoni huwa transitorju f’ 7% tal- pazjenti (1% ta ’ l - injezzjonijiet) meta ngħataw injezzjoni waħda ta ’ 5ml injezzjoni.
2 the vast majority < 2xULN
2 l- akbar numru < 2xULN
There is no human experience of overdose.
L- ebda każ ta ’ doża eċċessiva ma ġie rrappurtat fil- bnedmin.
If overdose occurs, symptomatic supportive treatment is recommended.
Studji li saru fuq l- annimali implikaw li l - ebda effett ma kien evidenti ħlief dawk relatati direttament jew indirettament ma ’ l- attivita` anti - estroġenika b’ dożi għolja ta ’ fulvestrant (ara sezzjoni 5. 3) F’ każ ta ’ doża eċċessiva wieħed għandu jikkura skond is- sintomi.
Anti-estrogens, ATC code:
Kategorija Farmakoterapewtika: anti- estroġenu, ATC code:
Mechanism of action Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.
Mekkaniżmu ta ’ l- azzjoni Fulvestrant huwa antagonist kompetittiv tar- riċettur ta ’ l- estroġenu u jorbot mar- riċetturi ta ’ l- estroġenu b’ affinita` li tqabbel ma dik ta ’ estradiol.
Fulvestrant blocks the trophic actions of estrogens without any partial agonist (estrogen-like) activity.
Fulvestrant jimblokka l- azzjoni ittrofika ta ’ l- estrogeni mingħajr ma hu stess ma għandu xi attivita` agonistika parzjali (bħal estrogenu).
The mechanism of action is associated with down-regulation of estrogen receptor protein levels.
Il- mekkaniżmu ta ’ kif jaħdem huwa relatat ma ’ tnaqqis (down- regulation) tar- riċettur tal- proteina ta ’ l- estrogenu (ER).
4 Clinical trials in postmenopausal women with primary breast cancer have shown that fulvestrant significantly down-regulates ER protein in ER positive tumours compared with placebo.
Provi kliniċi li saru fuq nisa li għaddew mill- menopawża li kellhom tumur tas- sider primarju indikaw li fulvestrant inaqqas( down- regulation) b’ mod sinifikattiv, il - proteina ER f’ tumuri li huma posittivi għal ER meta mqabbla ma ’ placebo.
There was also a significant decrease in progesterone receptor expression consistent with a lack of intrinsic estrogen agonist effects.
Kien hemm ukoll nuqqas sinifikanti f’ espressjonijiet tar- riċettur ta ’ progesterone konsistenti ma nuqqas ta ’ effetti agonistiċi intrinsiċi estroġenali.
Clinical safety and efficacy in advanced breast cancer Two phase III clinical trials were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Effikaċja u sigurta klinika f ’ kanċer tas- sider fi stat avvanzat Żewġ provi kliniċi Fażi III saru fuq total ta ’ 851 nisa li għaddew mill - menopawża u li kellhom kanċer tas- sider fi stat avvanzat u reġgħet qabdithom il- marda waqt jew wara t- terapija miżjuda endrokinali jew li l- marda kompliet tiżdied wara t- terapija endokrinali għal marda avvanzata.
77% of the study population had estrogen receptor positive breast cancer.
77% tal- popolazzjoni fl - istudju kellhom kanċer tas- sider posittiv għar- riċettur ormonali ta ’ l- estroġenu.
These trials compared the safety and efficacy of monthly administration of 250 mg fulvestrant versus the daily administration of 1 mg anastrozole (aromatase inhibitor).
Dawn il- provi qabblu s- sigurta u l- effikaċja ta ’ l- amministrazzjoni ta ’ 250mg fulvestrant kull xahar ma anastrozole, (inibittur ta ’ aromatase) b’ doża ta ’ 1mg kuljum.
Overall, fulvestrant at the 250 mg monthly dose was at least as effective as anastrozole in terms of time to progression, objective response, and time to death.
Kollox ma kollox, fulvestrant b’ doża ta ’ 250mg kull xahar kellu mill- inqas l- istess effett bħal anastrozole f’ dak li hu żmien biex il- marda tiżdied, rispons oġġettiv u tul ta ’ ħajja.
There were no statistically significant differences in any of these endpoints between the two treatment groups.
Ma kien hemm l- ebda differenzi statistikament sinifikanti bejn iż- żewġ metodi ta ’ kura fl- ebda wieħed minn dawn il- punti tat- tmiem.
Time to progression was the primary endpoint.
Iż - żmien sa kemm il- marda tiżdied kien il- punt tat- tmiem primarju.
Combined analysis of both trials showed that 83% of patients who received fulvestrant progressed, compared with 85% of patients who received anastrozole.
L- analiżi meħudin f’ daqqa taż- żewġ provi wrew li fi 83% tal- pazjenti li ħadu fulvestrant, il- marda żdiedet, meta mqabbla ma ’ 85% tal- pazjenti li ħadu anastrozole.
The hazard ratio of fulvestrant to anastrozole for time to progression was 0.95 (95% CI 0.82 to 1.10).
Il- proporzjon ta’ riskju bejn fulvestrant u anastrozole fi żmien biex tiżdied il- marda kien 0. 95 (95% CI 0. 82 għal 1. 10).
The objective response rate for fulvestrant was 19.2% compared with 16.5% for anastrozole.
Ir- rata ta ’ rispons oġġettiv għal fulvestrant kienet ta ’ 19. 2% u 16. 5% għal anastrozole.
The median time to death was 27.4months for patients treated with fulvestrant and 27.6 months for patients treated with anastrozole.
Iż- żmien medju sal- mewt kien ta ’ 27. 4 il- xahar għal pazjenti trattati b’ fulvestrant u 27. 6 il- xahar għall- pazjenti trattati b’ anastrozole.
The hazard ratio of fulvestrant to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
5 u anastrozole kien ta ’ 1. 01 (95% CI 0. 86 għal 1. 19).
Analysis of results by ER status showed that the use of fulvestrant should be restricted to patients with ER positive breast cancer.
Analiżi tar- riżultati permess ta ’ l- istat ER wrew li l - użu ta ’ fulvestrant għandu jkun ristrett għal pazjenti b’ kanċer tas- sider posittiv għal ER.
A 2-week study in healthy postmenopausal volunteers treated with 20 μ g per day ethinylestradiol showed that pre-treatment with 250 mg fulvestrant resulted in significantly reduced stimulation of the postmenopausal endometrium, compared to pre-treatment with placebo, as judged by ultrasound measurement of endometrium thickness
Effetti fuq l- endometriju fi żmien ta ’ wara il- menopawża Data preklinika ma tindikax effett stimulanti ta ’ fulvestrant fuq l- endometriju fi żmien ta ’ wara l - menopawża. (ara sezzjoni 5. 3) Studju ta ’ 2 ġimgħat li sar fuq voluntiera b’ saħħithom, trattati b’ 20ug ethinylestradiol kuljum bi trattament minn qabel b’ doża ta ’ 250mg fulvestrant,, irriżulta f’ effett sinifikanti ta ’ nuqqas ta ’ stimulu ta ’ l- endometriju postmenopawżali, meta mqabbla ma oħrajn li ħadu plaċebo kif deher mill- ultrasound li kejjel il- ħxuna ta ’ l- endometriju tal- voluntiera li nagħtaw 20 mikrogramma ta ’ ethinyl estradiol kuljum.
There are no data on the long-term effects of fulvestrant on the postmenopausal endometrium.
M’ hemmx data fuq l- effetti fit- tul li fulvestrant għandu fuq l- endometriju f’ nisa li għaddew mill - menopawża.
No data are available regarding endometrial morphology.
M’ hemmx data rigward il- morfoloġija ta ’ l- endometriju.
In two short-term studies (1 and 12 weeks) with premenopausal patients with benign gynaecologic disease, no significant differences in endometrial thickness were observed by ultrasound measuring between fulvestrant and placebo groups.
F’ żewġ studji qosra (1 u 12 il- ġimgħa) f’ pazjenti fi żmien ta ’ qabel l- menopawża b’ mard ġinekoloġiku beninn, ma ġewx osservati differenzi fil- ħxuna ta ’ l- endometriju imkejjel bl- ultrasound bejn il- gruppi fulvestrant u plaċebo..
Effects on bone There are no long-term data on the effect of fulvestrant on bone.
Effeti fuq l- għadam M’ hemmx data fuq l- effett fit- tul ta ’ fulvestrant fuq l- għadam.
Absorption After administration of Faslodex long-acting as an intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (Cmax) are reached after about 7 days.
Wara li tingħata injezzjoni ta ’ Faslodex b’ injezzjoni intramuskolari li taħdem fit- tul, fulvestrant jiġi assorbit bil- mod u l- ogħla konċentrazzjoni fil- plażma (Cmax) tintlaħaq wara xi 7 ijiem.
Absorption continues for over one month, and monthly administration results in an approximate 2-fold accumulation.
Jibqa ’ jiġi assorbit għal aktar minn xahar u doża mgħotija kull xahar tirriżulta f’ akkumulazzjoni ta ’ kważi d- doppju.
Steady-state levels are reached after about 6 monthly injections, with the major part of the accumulation achieved after 3-4 doses.
Livelli fissi jintlaħqu wara xi 6 injezzjonijiet bil- parti l- kbira ta ’ l- akkumulazzjoni tirriżulta wara 3- 4 dożi.
At steady state, fulvestrant plasma concentrations are maintained within a relatively narrow range with approximately 2- to 3-fold difference between maximum and trough concentrations.
Konċentrazzjoni fissa fil- plażma ta ’ fulvestrant tinżamm f’ limiti relattivament dojoq b’ differenza bejn wieħed u ieħor ta ’ 2- 3 darbiet iktar bejn l- ogħla u l- inqass livelli ta ’ konċentrazzjoni.
After intramuscular administration, the exposure is approximately dose-proportional in the dose range 50 to 250 mg.
Wara injezzjoni fil- muskolu, il- ġisem huwa espost għal mediċina proporzjonalment skond id- doża fi skala minn 50 sa 250mg.
Distribution Fulvestrant is subject to extensive and rapid distribution.
Fulvestrant huwa suġġett għal distrubuzzjoni estensiva u ta ’ malajr.
The large apparent volume of distribution at steady state (Vdss) of approximately 3 to 5 l/ kg suggests that distribution is largely extravascular.
Il- volum kbir apparenti ta ’ distribuzzjoni fi stat (Vdss) huwa bejn wieħed u ieħor minn 3 sa 5l/ kg, li jissuġerixxi li d- distribuzzjoni komposta tas- sustanza huwa l- iktar exstra- vaskulari.
Fulvestrant is highly (99%) bound to plasma proteins.
Fulvestrant jingħaqad b’ rata għolja (99%) mal - proteini tal- plasma.
Very low density lipoprotein (VLDL), low 5 density lipoprotein (LDL), and high density lipoprotein (HDL) fractions are the major binding components.
Lipoproteini ta ’ densita` żgħira ħafna (VLDL), densita` żgħira (LDL) u ta ’ densita` għolja (HDL) huma prinċiparjament l- iktar komponenti li jingħaqdu.
No interaction studies were conducted on competitive protein binding.
Għalhekk ma sar l- ebda studju dwar l- interazzjoni tal- mediċina meta tingħaqad mal- proteina b’ mod kompetittiv.
The role of sex hormone-binding globulin (SHBG) has not been determined.
Ir- rwol tal- globulina li tingħaqqad ma ’ l- ormoni sesswali għadu ma ġiex determinat.
Metabolism The metabolism of fulvestrant has not been fully evaluated, but involves combinations of a number of possible biotransformation pathways analogous to those of endogenous steroids.
Il- metaboliżmu ta ’ fulvestrant ma ġiex evalwat kompletament, iżda jinvolvi numru ta ’ possibilitajiet ta ’ kombinazzjonijiet ta ’ meded ta ’ biotransformazzjoni analogi għal dawk ta ’ l - isterojdi endoġini.
Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in anti-estrogen models.
Il - metaboliti identifikati (jinkludu ta ’ 17- ketone, sulphone, 3- sulphate, 3 u 17- glucuronide). huma jew inqas attivi jew juru attivitajiet simili għal fulvestrant f’ mudelli ta ’ anti- estroġenu.
Studies using human liver preparations and recombinant human enzymes indicate that CYP3A4 is the only P450 isoenzyme involved in the oxidation of fulvestrant; however, non-P450 routes appear to be more predominant in vivo.
Studji fejn intużaw preparazzjonijiet tal- fwied tal- bniedem u enżimi umani rikombinanti jindikaw li CYP3A4 huwa l- uniku isoeżima P450 involut fl- ossidita` ta ’ fulvestrant, madankollu, in vivo, rotot ta` non- P450 jidhru li huma iktar dominanti.
In vitro data suggest that fulvestrant does not inhibit CYP450 isoenzymes.
Data in vitro tissuġerixxi li fulvestrant ma jimpedixxix isoenżimi CYP450.
Elimination Fulvestrant is eliminated mainly in metabolised form.
6 Fulvestrant jiġi eliminat l- iktar forma metaboliżżat.
The major route of excretion is via the faeces, with less than 1% being excreted in the urine.
Il- mod prinċipali ta ’ eliminazzjoni huwa fl- ippurgar u inqas minn 1% jiġi eliminat fl- urina.
Fulvestrant has a high clearance, 11±1.7 ml/ min/ kg, suggesting a high hepatic extraction ratio.
Fulvestrant għandu tneħħija ta ’ livell għoli 11 ±1. 7ml/ min/ kg li tindika proporzjon għolji ta ’ estrazzjoni epatika.
The terminal half-life (t1/ 2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
Il half – life terminali tiġi regolata skond ir- rata ta ’ assorbiment u ġiet stmata li hi ta ’ madwar 50 jum.
Special populations In a population pharmacokinetic analysis of data from phase III studies, no difference in fulvestrant’ s pharmacokinetic profile was detected with regard to age (range 33 to 89 years), weight (40-127 kg) or race.
Tagħrif farmakokinetiku li ħareġ b’ analiżi f’ popolazzjoni minn studji f ’ Fażi III ma wera l- ebda differenza fil- profil farmakokinetiku ta ’ fulvestrant ma dak li għandu x’ jaqsam ma l- eta (fil- limiti ta ’ bejn 33- 89 sena), mal- piż (40 - 127kg) jew mar- razza.
Renal impairment Mild to moderate impairment of renal function did not influence the pharmacokinetics of fulvestrant to any clinically relevant extent.
Indeboliment renali ħafif sa moderat ma kellux influwenza klinikament relevanti fil- farmakokinetika ta ’ fulvestrant.
Hepatic impairment The pharmacokinetics of fulvestrant has been evaluated in a single-dose clinical trial conducted in subjects with mild to moderate hepatic impairment (Child-Pugh class A and B).
Il- farmakokinteka ta ’ fulvestrant ġiet evalwata fi studju kliniku b’ doża waħda kondott f’ suġġetti b’ indeboliment epatiku ħafif sa moderat (Child- Pugh klassi A u B).
There was up to about 2.5-fold increase in AUC in subjects with hepatic impairment compared to healthy subjects.
Kien hemm żieda fl - AUC sa madwar 2. 5 aktar f’ suġġetti b’ indeboliment epatiku meta mqabbla ma suġġetti b’ saħħithom.
In patients administered Faslodex, an increase in exposure of this magnitude is expected to be well tolerated.
Żieda fl- espożizzjoni ta ’ dan il - kobor hi mistennija li tkun tollerata tajjeb minn pazjenti li jingħataw Faslodex.
Subjects with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Suġġetti li għandhom Suġġetti b’ indeboliment epatiku qawwi (Child- Pugh klassi C) ma ġewx evalwati.
5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurta ’ tal- mediċina
The acute toxicity of fulvestrant is low.
It- tossicita ’ akuta ta ’ fulvestrant hija baxxa.
Faslodex and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
Faslodex u formulazzjonijiet oħra ta ’ fulvestrant kienu tollerati tajjeb fi studji f’ dożi multipli meta ġew użati fl- annimali.
Local reactions, including myositis and granulomatoma at the injection site were attributed to the vehicle but the severity of myositis in rabbits increased with fulvestrant, compared to the saline control.
Reazzjonijiet lokali, inkluż miosite u granulomatoma fil- post ta ’ l- injezzjoni kienu attribwiti għas- sustanzi mħallta mal- mediċina, iżda, l- ħsara tal- miosite fil- fniek żdiedet b’ fulvestrant meta mqabbla ma kontrolli tas- salina.
In toxicity studies with multiple intramuscular doses of fulvestrant in rats and dogs, the anti-estrogenic activity of fulvestrant was responsible for most of the effects seen, particularly in the female reproductive system, but also in other organs sensitive to hormones in both sexes.
Minn studji fuq it- tossiċita li saru fuq firien u fi klieb, b’ dożi multipli ta ’ fulvestrant, l- attivita anti- estroġenika ta ’ fulvestrant kienet responsabbli għall- iktar mill- effetti li ġew osservati, speċjalment fis- sistema riproduttiva tas- sess femminili, iżda wkoll f’ organi oħra sensittivi għal ormoni fiż- żewġ sessi.
In dog studies following oral and intravenous administration, effects on the cardiovascular system (slight elevations of the S-T segment of the ECG [oral], and sinus arrest in one dog [intravenous]) were seen.
Minn studji fuq klieb ġie osservat li dożi li ngħataw kemm orali kif ukoll ġol- vina, kellhom effet fuq is - sistema kardjovaskulari (S- T segment ta ’ ECG [orali] kien ftit għoli, u każ wieħed ta ’ sinus arrest fuq kelb (ġol- vina).
These occurred at exposure levels higher than in patients (Cmax > 40 times) and are likely to be of limited significance for human safety at the clinical dose.
Dan ġara f’ annimali li ħadu dożi ta ’ fulvestrant ogħla milli ħadu il- pazjenti (Cmax > 40 il - darba) u għalhekk huma x’ aktarx ta ’ sinifikat limitat rigward is- sigurta ’ ta ’ doża klinika użata fil- bniedem.
Fulvestrant showed no genotoxic potential.
Fulvestrant ma wera l- ebda potenzjal ġenotossiku.
Fulvestrant showed effects upon reproduction and embryo/ foetal development consistent with its anti-estrogenic activity, at doses similar to the clinical dose.
Fulvestrant wera effett fuq is- sistema riproduttiva u l- iżvilupp ta’ embriju/ fetu konsistenti ma ’ l- azzjoni anti- estroġenika tiegħu b’ dożi simili għal dawk kliniċi.
In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed.
Fil- firien, ġie osservat, b’ mod riversibbli, nuqqas fil- fertilita ’ fis- sess femminili u fin- numru ta’ embriji li baqgħu ħajjin, ikkaġuna distoċja u żied l - anomalitajiet fil- fetu inkluż tagħwiġ fit- tarsu.
Rabbits given fulvestrant failed to maintain pregnancy.
Fi ’ fniek li ħadu fulvestrant ma wasslux it- tqala.
6 placental weight and post-implantation loss of foetuses were seen.
Kien hemm żieda fil- piż tal- plaċenta u telf tal- fetu, wara l- implant.
There was an increased incidence of foetal variations in rabbits (backwards displacement of the pelvic girdle and 27 pre-sacral vertebrae).
Kien hemm żieda ta ’ varjazzjonijiet tal - fetu tal- fniek (iċ- ċintura pelvika u is- 27 vertebra pre- sakrali resqu lura).
A two-year oncogenicity study in rats (intramuscular administration of Faslodex) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/ rat/ 15 days and an increased incidence of testicular Leydig cell tumours in males.
Studju ta ’ sentejn onkoġeniku fil- firien, (Faslodex mogħti ġol- muskolu) wera li kibret l- inċidenza ta ’ tumur beninn taċ- ċelluli granulożi ta ’ l- ovarju fil- firien feminili b’ doża għolja, 10mg/ far/ 15 – il ġurnata u żdiedet ukoll l- inċidenza ta ’ tumuri testikulari taċ- ċelluli Leydig fil- firien ta ’ sess maskili.
Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations.
Induzzjoni ta ’ dawn it- tumuri huwa konsistenti ma tibdil relatat mar- rispons farmakoloġiku endokrinali.
These findings are not of clinical relevance for the use of fulvestrant in postmenopausal women with advanced breast cancer.
Dawn l- istudji m’ għandhomx relevanza klinika għall- użu ta ’ fulvestrant f’ nisa li għaddew mill- menopawża b’ kanċer tas - sider fi stat avvanzat.
6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi.
Ethanol (96 per cent) Benzyl alcohol Benzyl benzoate Castor oil
Ethanol 96% Benzyl alcohol Benzyl benzoate Castor oil
Store the pre-filled syringe in the original package in order to protect from light.
Aħżen fil- friġġ 2°C - 8°C Aħżen is- siringa diġa mimlija fil- pakkett oriġinali biex ikun protett mid- dawl.
One clear type 1 glass pre-filled syringe with polystyrene plunger rod, fitted with a tamper-evident closure, containing 5 ml solution for injection.
Siringa, tal- ħġieġ, ċar (Tip 1) ġa mimlija li jkollha planġer ta ’ polystyrene. magħluqa b’ mod li tinduna jekk tiġi mbabsa Fiha soluzzjoni ta ’ 5ml għal injezzjoni u.
A safety needle (SafetyGlide) for connection to the barrel is also provided.
Ikollha safety needle (SafetyGlide) li tista ’ titwaħħal mas- siringa.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali għar- rimi u maniġġar
Instructions for administration Remove glass syringe barrel from tray and check that it is not damaged.
Istruzzjonijiet ta ’ kif jingħata Neħħi s- siringa tal- ħġieġ mit- trej u ċċekkja li ma fihiex ħsara.
Peel open the safety needle (SafetyGlide) outer packaging.
Iftaħ il- pakkett ta ’ barra li fih is- safety needle (SafetyGlide).
(For safety needle instructions see below).
(Għall- użu ta ’ safety needle aqra aktar l - isfel).
Twist to lock the needle to the Luer connector.
Dawwar biex twaħħal il- labra mal- Luer konnekter.
Remove needle sheath.
Neħħi l- għatu tal- labra.
Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
Qabel ma tuża soluzzjonijiet parenterali ara li ma tbiddilx il- kulur u li m ’ hemmx frak.
Remove excess gas from the syringe (a small gas bubble may remain).
Neħħi arja żejda mis- siringa (tista ’ tibqa ’ xi bużżieqa żgħira ta ’ arja).
Administer intramuscularly slowly into the buttock.
Agħti bil- mod fil- muskolu tal - warrani.
Visually confirm that the lever arm has fully advanced and the needle tip is covered.
Ara li d- driegħ tal- lever daħal kollu ’ l ġewwa u li l- ponta tal- labra hija mgħottija għal kollox.
If unable to activate the safety needle, discard immediately into an approved sharps collector.
Jekk ma tistax tattiva is- safety needle armi minufih f’ kaxxa approvata biex fiha tarmi affarijiet bil- ponta jew li jaqtgħu.
7 SafetyGlide Information from Becton Dickinson WARNING: - Do not autoclave safety needle before use.
Tisteriliżżax is- safety needle qabel l- użu.
Hands must remain behind the needle at all times during use and disposal.
Dejjem żomm il- labra minn wara waqt l- użu u meta tkun qed tarmiha.
Directions for Use of safety needle Peel apart packaging of the safety needle, break the seal of the white plastic cover on the syringe Luer connector and attach the safety needle to the Luer Lock of the syringe by twisting.
Neħħi s- safety needle mill- pakkett oriġinali, ikser is- siġill ta ’ l- għatu tal- plastik abjad oħroġ il- Luer konnekter tas- siringa u waħħal is- safety needle mal- Luer Lock tas- siringa billi ddawwar ’ l hawn u ’ l hinn.
Transport filled syringe to point of administration.
Ħu s- siringa mimlija sa ħdejn fejn se tiġi mogħtija.
Pull shield straight off needle to avoid damaging needle point.
Ikxef il- labra billi tneħħi l- għatu b’ mod dritt biex tevita li tagħmel ħsara lil- ponta tal- labra.
Administer injection following package instruction.
Agħti l- injezzjoni skond it- tagħrif fuq il- pakkett.
For user convenience, the needle ‘ bevel up’ position is orientated to the lever arm, as shown in Figure 3.
3.
Immediately activate needle protection device upon withdrawal from patient by pushing lever arm completely forward until needle tip is fully covered (Figure 2).
(Fig 2).
Visually confirm that the lever arm has fully advanced and the needle tip is covered.
Aċċerta ruħek viswalment li d- driegħ tal- lever mexa kollu ’ l quddiem u li l- ponta tal- labra hija mgħottija.
If unable to activate, discard immediately into an approved sharps collector.
Jekk ma tkunx tista ’ tattiva, armi minnufih fil- kaxxa appruvata biex jintremew affarijiet bil- ponta u li jaqtgħu.
Activation of the protective mechanism may cause minimal splatter of fluid that may remain on the needle after injection.
Attivazzjoni tal- mekkaniżmu prottetiv jista ’ jikkaġuna tixrid minimu tal- likwidu li jista ’ jibqa fuq il- labra wara l- injezzjoni
For greatest safety, use a one-handed technique and activate away from self and others.
Għall- aħjar sigurta` uża it- teknika t ’ id waħda u attiva il- bogħod minnek u minn oħrajn.
Disposal Pre-filled syringes are for single use only.
SID TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
Any unused product or waste material should be disposed of in accordance with local requirements.
Ltd Alderley Park Macclesfield Cheshire SK 10 4TG Renju Unit
MARKETING AUTHORISATION HOLDER AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom 8.
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID GĦALL- KUMMERĊ
10 March 2009
10 ta ’ Marzu 2004 10 ta ’ Marzu 2009 10.
DATE OF REVISION OF THE TEXT 9 ANNEX II
DATA TA’ META ĠIET RIVEDUTA IL- KITBA
CONDITIONS OF THE MARKETING AUTHORISATION
10 ANNESS II
10 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Name and address of the manufacturer responsible for batch release AstraZeneca UK Limited Silk Road Business Park, Macclesfield, SK10 2NA United Kingdom
11 A. < MANIFATTUR U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
B CONDITIONS OF THE MARKETING AUTHORISATION
AstraZeneca UK Limited Silk Road Business Park, Macclesfield, SK 10 2NA Renju Unit
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
B KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Medicinal product subject to medical prescription.
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Prodott mediċinali jingħata bir- riċetta tat- tabib.
12 A.
12 ANNESSI III
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW FIN- NUQQAS TA ’ DAN, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
CARTON
PAKKETT TAL- KARTUN
Faslodex 250 mg solution for injection. fulvestrant
Fulvestrant
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
Siringa diġa` mimlija u li fiha 250mg fulvestrant f’ soluzzjoni ta ’ 5ml.
See the package leaflet for further information.
LISTA TA ’ SUSTANZI MHUX ATTIVI Ethanol 96% Benzyl alcohol Benzyl benzoate Castor oil Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni
Solution for injection in a pre-filled syringe.
Soluzzjoni għall- injezzjoni f’ siringa diga` mimlija.
1 pre-filled syringe (5 ml) 1 safety needle (SafetyGlide)
1 Siringa diġa ’ mimlija (5ml) 1 safety needle (SafetyGlide).
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu Fil- muskolu.
Intramuscular use.
Għal użu ta ’ darba biss.
For full instructions on the administration of Faslodex and the use of the safety needle see enclosed Instructions for Use.
Għal aktar tagħrif fuq kif jingħata Faslodex u l- użu tas- safety needle ara l- Karatteristiċi tal- Prodott li ssib fil- pakkett.
Store in a refrigerator.
DATA TA ’ META JISKADI 15 JIS
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻENJALI Aħżen fil- friġġ, Aħżen is- siringa diġa mimlija fil- kontenitur oriġinali biex tħares mid- dawl.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom
AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK 10 4TG Renju Unit
Justification for not including Braille accepted.
INFORMAZZJONI BIL - BRAILLE Ġustifikazzjoni biex ma tinkludix braille aċċettata
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA SIRINGA DIGA MIMLIJA
Faslodex 250 mg solution for injection fulvestrant IM use
Faslodex 250mg soluzzjoni għal Injezzjoni. fulvestrant użu IM
METHOD OF ADMINISTRATION
METODU TA ’ KIF GĦANDU JINGHATA
17 PACKAGE LEAFLET:
19 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN JUŻAĦ
Read all of this leaflet carefully before you start using this medicine.
Aqra dan il- fuljett b’ attenzjoni qabel tibda tieħu din il- mediċina.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi t- tabib, infermiera jew lill- ispiżjar tiegħek.
It may harm them, even
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lill- persuni oħra.
if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħall- tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi effetti sekondarji jkunu serji, jew jekk tinnota xi effetti sekondarji li ma humiex elenkati f’ dan
please tell your doctor, nurse or pharmacist.
il- fuljett, jekk joġgħbok għid lit- tabib, infermier jew lill- ispiżjar tiegħek
How to store Faslodex 6.
X’ inhu Faslodex u għalxiex jintuża Qabel ma tuża Faslodex Kif għandek tuża Faslodex X’ effetti oħra jista ’ jkollu Kif taħżen Faslodex.
Further information
Aktar tagħrif.
WHAT FASLODEX IS AND WHAT IT IS USED FOR
X’ inhu faslodex u għalxiex jintuża
Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Faslodex fih is- sustanza attiva fulvestrant li jagħmel parti mill- grupp li jibblokka l- estroġenu.
Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.
Estroġeni huma tip ta ’ ormoni sesswali femminili li f’ ċerti każijiet jistgħu jkunu involuti fit- tkabbir tal- kanċer tas - sider
Faslodex is used to treat advanced or metastatic breast cancer in postmenopausal women.
Faslodex jintuża għall- kura tal- kanċer tas- sider fi stat avvanzat jew metastatiku f’ nisa li għaddew mill - menopawża
BEFORE YOU USE FASLODEX
QABEL MA TUŻA FASLODEX
Do not use Faslodex
Tużax Faslodex
- if you are allergic (hypersensitive) to fulvestrant or to any of the other ingredients of Faslodex
- Jekk tbagħti minn sensittivita eċċessiva (allerġija) għal fulvestrant jew sustanzi oħra ta ’ Faslodex.
(listed in section 6 ‘ What Faslodex contains’)
(elenkati f’ sezzjoni 6 ‘ X’ fih Faslodex ’)
- if you are pregnant or breast-feeding
- Jekk int tqila jew qed tredda`.
- if you have severe liver problems
- Jekk għandek problemi serji fil- fwied.
Take special care with Faslodex Tell your doctor if any of these apply to you:
Avża lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik:
- kidney or liver problems
- problemi fil- kliewi jew fil- fwied.
- low numbers of platelets (which help blood clotting) or bleeding disorders
- numru ta ’ plejtlet fid- demm baxx,. (li jgħinu d- demm jagħqad) jew kundizzjonijiet ta ’ telf tad- demm
- previous problems with blood clots
- kellek problemi ta ’ tagħqid ta demm.
- osteoporosis (loss of bone density)
(tnaqqis fid- densita tal- għadam)
- Alcoholism
- Alkoħoliżmu
In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).
Użu ta ’ mediċini oħra:
If you can become pregnant, you should use effective contraception while being treated with Faslodex.
20 Jekk jogħġbok għarraf lit- tabib, l- infermiera jew l- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra anki mhux bir- riċetta Mod partikulari għid lit- tabib tiegħek jekk qed tuża xi antikoagulanti (mediċini li jwaqqfu d- demm milli jagħqad).
You must not breast-feed while on treatment with Faslodex.
Tqala u treddigħ:
18 Driving and using machines Faslodex is not expected to affect your ability to drive or use machines.
Tużax Faslodex jekk int tqila.
However, if you feel tired after treatment do not drive or use machines.
Jekk tista toħroġ tqila għandek tuża kontraċezzjoni effettiva waqt it - trattament b’ Faslodex.
Important information about some of the ingredients of Faslodex
Ma għandekx tredda ’ waqt li tkun fuq trattament b’ Faslodex
Harmful for those suffering from alcoholism.
Sewqan u tħaddim ta ’ magni:
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Mhux suppost li Faslodex itellfek milli ssuq jew tħaddem magni, iżda jekk tħossok għajjiena wara il- kura b’ Faslodex issuqx u tħaddimx magni.
The usual dose is 250 mg fulvestrant (one 5 ml injection) given once a month.
KIF TUŻA FASLODEX Id- doża normali hija 250mg fulvestrant (injezzjoni waħda ta ’ 5ml) darba fix- xahar.
Your doctor or nurse will give you Faslodex as a slow intramuscular injection into your buttock.
Bħala injezzjoni trid tingħata bil- mod fil - muskolu tal- warrani.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA JKOLLU
Like all medicines, Faslodex can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Faslodex jista ’ jkollu effetti Jista ’ jkun li ma tħossx xejn minn dawn.
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jokkorru b’ ċertu frekwenzi, definiti kif ġej: • komuni ħafna: jaffetwa aktar minn 1 minn kull 10 pazjenti • komuni: jaffetwa minn 1 sa 10 minn kull 100 pazjent • mhux komuni: jaffetwa minn 1 sa 10 minn kull 1, 000 pazjent • rari: jaffetwa minn 1 sa 10 minn kull 10, 000 pazjent • rari ħafna: jaffetwa inqas minn 1 minn kull 10, 000 pazjent • mhux magħruf: il- frekwenxa ma tistax tiġi stmata minn data li għandna
Very common side effects • Hot flushes
• Fwawar ta ’ sħana
Common side effects • Injection site reactions, such as pain and/ or inflammation • Headache • Weakness and tiredness • Nausea (feeling sick), vomiting, diarrhoea or loss of appetite • Rash • Urinary tract infections • Back pain • Increased risk of blood clots • Abnormal levels of liver enzymes (in blood tests)
• Reazzjonijiet fil- post ta ’ l- injezzjoni, bħal uġigħ u/ jew infjammazzjoni • Uġigħ ta ’ ras • Għajja u bla saħħa • dardir (tħossok imdardar) remettar (tirremetti), dijarea jew nuqqas ta ’ aptit. • Raxx • Infezzjoni fil- passaġġ ta ’ l- awrina • Uġigħ fid- dahar • Żieda fir- riskju li jagħqad id- demm • Livelli abnormali tal- enzimi tal- fwied (fit- testijiet tad- demm)
Uncommon side effects • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/ or throat • Vaginal bleeding, thick, whitish discharge and candidiasis (infection)
Effetti sekondarji mhux komuni • Reazzjonijiet allerġiċi, li jinkludu nefħa tal- wiċċ, xuftejn, ilsien u/ jew grismejn • Telf ta ’ demm mill- vaġina • Infezzjoni ta ’ fungu fil- vaġina, (candidiasis), tisfija mill- vaġina
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
21 Jekk xi effetti sekondarji jsiru serji jew jekk tinduna b’ xi effeti sekondarji oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib, l- infermiera jew spiżjar tiegħek.
HOW TO STORE FASLODEX
KIF TAĦŻEN FASLODEX
Store in a refrigerator (2°C – 8°C) Keep the pre-filled syringe in the original package, in order to protect from light.
Żomm is- siringa diġa mimlija fil- pakkett oriġinali sabiex tilqa mid- dawl.
Do not use after the expiry date which is stated on the carton or syringe label after the abbreviation EXP.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq il- pakkett jew fuq it- tikketta tas- siringa, wara JIS.
The expiry date refers to the last day of that month.
Id - data ta ’ meta jiskadi hija l- aħħar ġurnata ta ’ dak ix- xahar
Your health care professional will be responsible for the correct storage, use and disposal of Faslodex.
L- istaff mediku huwa reponsabbli għal ħażna, użu u rimi ta ’ Faslodex kif suppost.
What Faslodex contains
X’ fiħ Faslodex Is- sustanza attiva hi fulvestrant.
Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Kull siringa diġa mimlija (5ml) fiha 250mg fulvestrant.
- The other ingredients are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil.
Sustanzi oħra huma ethanol 96%, benzyl alcohol, benzyl benzoate u castor oil.
What Faslodex looks like and contents of the pack Faslodex is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection A safety needle (SafetyGlide) for connection to the barrel is also provided.
U Ikollha safety needle (SafetyGlide) li tista ’ titwaħħal mas- siringa
Marketing Authorisation Holder AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom
Astra Zeneca Uk Limtied Alderley Park Macclesfield Cheshire SK10 4 TG Renju Unit
Manufacturer AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
Astra Zeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK 10 2NA Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
22 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ.
Magyarország AstraZeneca Kft Tel: +36 23 517 300
Tel: +36 23 517 300
Ltd Tel: +356 21232175
Tel: +356 22778000
Nederland AstraZeneca BV Tel: +31 79 363 2222
Tel: +31 79 363 2222
Österreich AstraZeneca Österreich GmbH
Österreich Polska AstraZeneca Österreich GmbH Tel: +43 1 711 31 310
Polska AstraZeneca Pharma Poland Sp. z o. o.
AstraZeneca Pharma Poland Sp. z o. o.
United Kingdom AstraZeneca UK Ltd
United Kingdom AstraZeneca UK Ltd Tel: + 44 01582 836 836
21 This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar f ’
The following information is intended for healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku
Faslodex 250 mg/ 5 ml solution for injection.
Faslodex 250mg/ 5ml soluzzjoni għall- injezzjoni..
Pre-filled syringe.
Siringa diga` mimlija
Instructions for administration
Struzzjonijiet ta ’ kif jingħata
Remove glass syringe barrel from tray and check that it is not damaged.
Neħħi s- siringa tal- ħġieġ mit- trej u ċċekkja li ma fihiex ħsara.
Remove excess gas from the syringe (a small gas bubble may remain).
24 Neħħi arja żejda mis- siringa (tista ’ tibqa ’ xi bużżieqa żgħira ta ’ arja).
SafetyGlide Information from Becton Dickinson
Tagħrif fuq SafetyGlide minn Becton Dickinson
WARNING: - Do not autoclave safety needle before use.
Tisteriliżżax is- safety needle qabel l- użu.
Directions for Use of safety needle
Tagħrif dwar l -- użu tas- safety needle
Peel apart packaging of the safety needle, break the seal of the white plastic cover on the syringe Luer connector and attach the safety needle to the Luer Lock of the syringe by twisting.
Neħħi s- safety needle mill- pakkett oriġinali, ikser is- siġill ta ’ l- għatu tal- plastik abjad oħroġ il- Luer konnekter tas- siringa u waħħal is- safety needle mal- Luer Lock tas- siringa billi ddawwar ’ l hawn u ’ l hinn.
Administer injection following instructions above.
Agħti l- injezzjoni skond it- tagħrif fuq il- pakkett.
Any unused product or waste material should be disposed of in accordance with local requirements.
Rimi Siringi ġa mimlija għandhom jintużaw darba biss Prodott li ma jintużax u materjal ieħor għandu jiġi mormi skond ir- regolamenti lokali għal imaniġġjar u r - rimi
22 23
25 26
What is Fasturtec?
X’ inhu Fasturtec?
Fasturtec is a medicine containing the active substance rasburicase.
Fasturtec hu mediċina li fiha s- sustanza attiva rasburicase.
It is available as a powder and solvent, which are made up into a solution for infusion (drip into a vein) with 1.5 mg rasburicase in 1 ml.
Jiġi bħala trab u solvent, li jitħalltu biex jiffurmaw soluzzjoni għall- infużjoni (dripp f’ vina) b’ 1. 5 mg rasburicase f’ 1 ml.
What is Fasturtec used for?
Għal xiex jintuża Fasturtec?
Fasturtec is used to treat and prevent acute (sudden) hyperuricaemia (increased levels of uric acid in the blood), in order to prevent kidney failure.
Fasturtec jintuża biex jittratta u jipprevjeni żidiet akuti (f’ daqqa) ta ’ l- aċidu uriku fid- demm, biex jipprevjeni l- falliment tal- kliewi.
Fasturtec is used in patients with haematological malignancies (blood cancers) who are at risk of a rapid tumour lysis (breakdown) or shrinkage at the start of chemotherapy (medicines given for cancer).
Fasturtec jintuża f’ pazjenti b’ tibdiliet malinni ematoloġiċi (kankrijiet fid- demm) li jkollhom riskju li t- tumur jitkisser jew jinxtorob malajr fil- bidu tal- kimoterapija (mediċini li jingħataw għall- kankru).
How is Fasturtec used?
Għal xiex jintuża Fasturtec?
Fasturtec treatment should be supervised by a doctor who has been trained in the chemotherapy of haematological malignancies.
It- trattament b’ Fasturtec għandu jiġi sorveljat minn tabib li jkun tħarreġ fil- kimoterapija ta ’ tibdiliet malinni ematoloġiċi.
Fasturtec is given at the start of chemotherapy.
Fasturtec jingħata fil- bidu tal- kimoterapija.
The recommended dose is 0.20 mg per kilogram body weight in both children and adults given as a daily infusion for up to seven days.
Id- doża rakkomandata hi ta ’ 0. 20 mg għal kull kilogramma li jiżen il- pazjent kemm fit- tfal u kemm f’ adult u tingħata bħala infużjoni kuljum għal sebat ijiem.
The duration of treatment is adjusted depending on the patient ’ s uricaemia (blood levels of uric acid) and the doctor's judgment.
Id- dewmien tat- trattament jiġi aġġustat skond l- uriċemija (il- livelli ta ’ l- aċidu uriku fid- demm) tal- pazjent u skond il- ġudizzju tat- tabib.
The infusion should last 30 minutes.
L- infużjoni għandha ddum 30 minuta.
How does Fasturtec work?
Kif jaħdem Fasturtec?
When patients with blood cancers start chemotherapy, they are at risk of developing hyperuricaemia.
Meta l- pazjenti b’ kankri fid- demm jibdew il- kimoterapija, dawn ikunu f’ riskju li jiżviluppaw livelli għolja ta ’ iperuriċemija.
This is because the chemotherapy destroys the tumour cells, breaking down the genetic material in the cells, and leading to a sharp increase in the levels of uric acid in the blood.
Dan għaliex il- kimoterapija teqred iċ- ċelloli tat- tumur u tkisser il- materjal ġenetiku fiċ- ċelloli tat- tumur, u dan iwassal għal żieda f’ daqqa fil- livelli ta ’ l- aċidu uriku fid- demm.
The body cannot get rid of too much uric acid, so it can accumulate in the kidneys, causing them to fail (stop working).
Il- ġisem ma jkunx jista ’ jeħles minn ħafna mill- aċidu uriku, u għalhekk dan jista ’ jakkumula fil- kliewi u jġegħelhom ifallu (jieqfu jaħdmu).
The active substance in Fasturtec, rasburicase, is an enzyme called urate oxidase, which is able to transform uric acid into another chemical called allantoin.
Is- sustanza attiva f’ Fasturtec, rasburicase, hu enżim magħruf bħala urate oxidase, li hu kapaċi jittrasforma l- aċidu uriku f’ kimika oħra magħrufa bħala allantoin.
Allantoin can easily be excreted by the kidneys in the urine.
Allantoin jista ’ jinħareġ mill- kliewi għal ġo l- awrina.
The enzyme was originally extracted from a fungus, but in Fasturtec it is produced by a method known as ‘ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA) that makes it able to produce urate oxidase.
L- enżim oriġinarjament kien estratt minn fungu, iżda f’ Fasturtec jiġi prodott b’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: jiġi magħmul minn ħmira li tkun irċeviet ġene (DNA) li tagħmilha kapaċi tipproduċi urate oxidase.
How has Fasturtec been studied?
Kif ġie studjat Fasturtec?
Fasturtec has been studied in four studies involving a total of 372 patients.
Fasturtec ġie studjat f’ erba ’ studji ewlenin li fihom b’ kollox ħadu sehem 372 pazjent.
Fasturtec was only compared to another treatment (allopurinol, the 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Żewġ studji minnhom ġew disinjati b’ mod li tiġi definita l- aħjar doża għall- użu. F’ wieħed mill- istudji, li fih ħadu sehem 52 pazjent, Fasturtec tqabbel biss ma ’ trattament ieħor (allopurinol, it- trattament standard għat - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged standard treatment for reducing uric acid levels) in one of the studies, which included 52 patients.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged tnaqqis tal- livelli ta ’ l- aċidu uriku).
In this study, the main measure of effectiveness was the amount of uric acid in the blood, measured over 96 hours.
F’ dan l- istudju, il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien l - ammont ta ’ aċidu uriku fid- demm, imkejjel matul 96 siegħa.
What benefit has Fasturtec shown during the studies?
X’ benefiċċju ta ’ Fasturtec intwera f’ dawn l- istudji?
The dose-finding studies showed that, after 48 hours, Fasturtec at a dose of 0.20 mg/ kg reduced the uric acid levels to normal values in 95% of patients.
L- istudji għas- sejbien ta ’ l- aħjar doża wrew li, wara 48 siegħa, Fasturtec f’ doża ta ’ 0. 20 mg/ kg naqqas il- livelli ta ’ aċidu uriku għall- valuri normali f’ 95% tal- pazjenti.
In the comparative study, Fasturtec was more effective than allopurinol: over the first 96 hours after treatment, patients treated with Fasturtec had a lower average blood level of uric acid compared that in the patients treated with allopurinol (128.1 and 328.5 mg. h/ dl, respectively).
Fl- istudju tat- tqabbil, Fasturtec kien iktar effettiv minn allopurinol: matul l- ewwel 96 siegħa wara t- trattament, il- pazjenti ttrattati b’ Fasturtec kellhom medja iktar baxxa ta ’ aċidu uriku fid- demm imqabbla ma ’ pazjenti ttrattati b ’ allopurinol (128. 1 u 328. 5 mg. h/ dl, rispettivament).
What is the risk associated with Fasturtec?
X’ riskju hu assoċjat ma ’ Fasturtec?
The most common side effects with Fasturtec (seen in between 1 and 10 patients in 100) are allergic reactions, mainly rashes, and fever.
L- iktar effetti sekondarji komuni ma ’ Fasturtec (li dehru b’ bejn pazjent wieħed u għaxra minn kull mija) jinkludu reazzjonijiet allerġiċi, prinċiparjament raxx, u deni.
Patients should be closely monitored for allergic reactions during treatment.
Il- pazjenti għandhom jiġu sorveljati mill- qrib għal reazzjonijiet allerġiċi waqt it- trattament.
For the full list of all side effects reported with Fasturtec, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rappurtati ma ’ Fasturtec, ara l- Fuljett ta ’ Tagħrif.
Fasturtec should not be used in patients who are hypersensitive (allergic) to rasburicase or any of the other ingredients.
Fasturtec m’ għandux jintuża għal pazjenti allerġiċi għal rasburicase jew għal kwalunkwe mill - ingredjenti l- oħra.