qanastek/EMEA-V3 huggingface dataset:
Absorption Following administration of a single 25 mg intravenous dose of temsirolimus in patients with cancer, mean Cmax in whole blood was 585 ng/ ml (coefficient of variation, CV = 14%), and mean AUC in blood was 1627 ng• h/ ml (CV = 26%).
Assorbiment Wara l- għoti ta ’ doża waħda ta ’ 25 mg ġol- vini ta ’ temsirolimus f’ pazjenti bil- kanċer, il- medja tas- Cmax fid- demm sħiħ kienet ta ’ 585 ng/ ml (koeffiċjent tal- varjazzjoni, CV = 14%), u l - medja ta ’ l- AUC fid- demm kienet ta ’ 1627 ng• h/ ml (CV = 26%).
Distribution Temsirolimus exhibits a polyexponential decline in whole blood concentrations, and distribution is attributable to preferential binding to FKBP-12 in blood cells.
Distribuzzjoni Temsirolimus juri tnaqqis polijesponenzjali fil- konċentrazzjonijiet tad- demm sħiħ, u d- distribuzzjoni hi attribwibbli għat- twaħħil preferenzjali ma ’ FKBP- 12 fiċ- ċelluli tad- demm.
The mean (standard deviation, SD) dissociation constant (Kd) of binding was 5.1 (3.0) ng/ ml, denoting the concentration at which 50% of binding sites in blood cells were occupied.
Il- medja (devjazzjoni standard, SD) dissoċjazzjoni kostanti (Kd) tat- twaħħil kienet ta ’ 5. 1 (3. 0) ng/ ml, li tindika l - konċentrazzjoni li fiha 50% tas- siti tat- twaħħil fiċ- ċelluli tad- demm, kienu okkupati.
Following a single
Id- distribuzzjoni ta ’ temsirolimus tiddependi mid- doża, bil- medja (l- 10 u d- 90 percentiles) tat- twaħħil speċifiku massimu fiċ- ċelluli tad- demm ta ’ 1. 4 mg (0. 47 sa 2. 5 mg).
12 25 mg temsirolimus intravenous dose, mean steady-state volume of distribution in whole blood of patients with cancer was 172 liters.
Wara l- għoti ta ’ doża waħda ta ’ 25 mg ġol - vini ta ’ temsirolimus, il- medja tad- distribuzzjoni tal- volum fl- istat fiss fid- demm sħiħ ta ’ pazjent bil - kanċer kienet ta ’ 172 litru.
Metabolism Sirolimus, an equally potent metabolite to temsirolimus, was observed as the principal metabolite in humans following intravenous treatment.
Metaboliżmu Sirolimus, metabolit li hu qawwi bl- istess mod għal temsirolimus, kien osservat bħala l- metabolit prinċipali fil- bnedmin wara l- kura permezz ta ’ l- għoti ġol- vini.
During in vitro temsirolimus metabolism studies, sirolimus, seco-temsirolimus and seco-sirolimus were observed; additional metabolic pathways were hydroxylation, reduction and demethylation.
Waqt studji dwar il- metaboliżmu in vitro ta ’ temsirolimus, sirolimus, seco- temsirolimus u seco- sirolimus kienu osservati; passaġġi metaboliċi addizzjonali kienu hydroxylation, tnaqqis u demethylation.
Following a single 25 mg intravenous dose in patients with cancer, sirolimus AUC was 2.7-fold that of temsirolimus AUC, due principally to the longer half-life of sirolimus.
Wara doża waħda ta ’ 25 mg ġol- vini f’ pazjenti bil- kanċer, l- AUC ta ’ sirolimus kienet ta ’ 2. 7 darbiet ta ’ l- AUC ta ’ temsirolimus, minħabba prinċipalment il- half- life itwal ta ’ sirolimus.
Elimination Following a single 25 mg intravenous dose of temsirolimus, temsirolimus mean ±SD systemic clearance was 11.4 ± 2.4 l/ h.
Eliminazzjoni Wara doża waħda ta ’ 25 mg ġol- vini ta ’ temsirolimus, il- medja ±SD sistemika tat- tneħħija ta ’ temsirolimus kienet ta ’ 11. 4± 2. 4 l/ siegħa.
Mean half-lives of temsirolimus and sirolimus were 17.7 hr and 73.3 hr, respectively.
Il- medja tal- half- lives ta ’ temsirolimus u ta ’ sirolimus kienu 17. 7 sigħat u 73. 3 sigħat, rispettivament.
Following administration of [14C] temsirolimus, excretion was predominantly via the faeces (78%), with renal elimination of active substance and metabolites accounting for 4.6% of the administered dose.
Wara l- għoti ta ’ [14C] temsirolimus, it- tneħħija kienet il- biċċa l- kbira permezz ta ’ l- ippurgar (78%), b’ eliminazzjoni renali tas- sustanza attiva u tal- metaboliti li jammontaw għal 4. 6% tad- doża li tingħata.
Temsirolimus and sirolimus were demonstrated to be substrates for P-gp in vitro.
Intwera li temsirolimus u sirolimus kienu sottostrati għal P- gp in vitro.
Possible effects of inhibition of P-gp on elimination of temsirolimus and sirolimus in vivo have not been investigated.
L- effetti possibbli ta ’ l - inibizzjoni ta 'P- gp fuq l- eliminazzjoni ta ’ temsirolimus u sirolimus in vivo ma kinux investigati.
Special Populations Hepatic impairment Temsirolimus and sirolimus pharmacokinetics have not been investigated in patients with hepatic impairment (see sections 4.2 and 4.4).
Popolazzjonijiet Speċjali Indeboliment tal- fwied Il- farmakokinetiċi ta ’ temsirolimus u ta ’ sirolimus ma kinux investigati f’ pazjenti b’ indeboliment tal - fwied (ara sezzjonijiet 4. 2 u 4. 4).
Gender, weight, race, age Temsirolimus and sirolimus pharmacokinetics are not significantly affected by gender or body weight.
12 Sess, piż, razza, età Il- farmakokinetiċi ta ’ temsirolimus u ta ’ sirolimus mhumiex affettwati b’ mod sinifikanti mis- sess jew mill- piż tal- ġisem.
No relevant differences in exposure were apparent when data from the Caucasian population was compared with either the Japanese or Black population.
L- ebda differenzi rilevanti fl- espożizzjoni ma kienu evidenti meta wieħed iqabbel l - informazzjoni dwar il- popolazzjoni Kawkasa mal- popolazzjoni Ġappuniża jew Sewda.
Pharmacokinetic data on temsirolmus and sirolimus are available in patients up to age 79 years.
Informazzjoni farmakokinetika fuq temsirolmus u sirolimus hi disponibbli f’ pazjenti sa l- età ta ’ 79 sena.
Age does not appear to affect temsirolimus and sirolimus pharmacokinetics significantly.
L- età ma tidhirx li taffettwa l- farmakokinetiċi ta ’ temsirolimus u ta ’ sirolimus b’ mod sinifikanti.
Paediatric population Temsirolimus and sirolimus pharmacokinetics in the paediatric population have not been investigated.
Popolazzjoni pedjatrika Il- farmakokinetiċi ta ’ temsirolimus u ta ’ sirolimus fil- popolazzjoni pedjatrika ma kinux investigati.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to or even lower than clinical exposure levels and with possible relevance to clinical use, were as follows: pancreatic islet cell vacuolation (rat), testicular tubular degeneration (mouse, rat and monkey), lymphoid atrophy (mouse, rat and monkey), mixed cell inflammation of the colon/ caecum (monkey), and pulmonary phospholipidosis (rat).
Reazzjonijiet avversi li ma kinux osservati fi studji kliniċi, iżda li kienu osservati fl- annimali f’ livelli ta ’ espożizzjoni simili għal, jew anki iktar baxxi mil- livelli ta ’ espożizzjoni klinika, u b’ rilevanza possibbli għall- użu kliniku, kienu kif ġej: vakwolazzjoni taċ- ċelluli islet pankreatiċi (firien), deġenerazzjoni tubulari testikulari (fil- ġrieden, fil- firien u fix- xadini), atrofija limfojde (fil- ġrieden, fil - firien u fix- xadini), infjammazzjoni taċ- ċelluli mħallta tal- kolon/ cecum (fix- xadini), u fosfolipidosi pulmonari (fil- firien).
13 Diarrhoea with mixed cell inflammation of the caecum or colon was observed in monkeys and was associated with an inflammatory response, and may have been due to a disruption of the normal intestinal flora.
Dijarea b’ infjammazzjoni taċ- ċelluli mħallta tas- caecum jew tal- kolon kienet osservata fix- xadini u kienet assoċjata ma ’ rispons infjammatorju, u setgħet seħħet minħabba l- interruzzjoni tal- flora intestinali normali.
General inflammatory responses, as indicated by increased fibrinogen and neutrophils, and/ or changes in serum protein, were observed in mice, rats, and monkeys, although in some cases these clinical pathology changes were attributed to skin or intestinal inflammation as noted above.
Risponsi infjammatorji ġenerali, kif indikati minn żieda fil- fibrinoġen u newtrofili, u/ jew bidliet fil - proteini fis- serum, kienu osservati fil- ġrieden, firien, u xadini, għalkemm f’ xi każijiet dawn il- bidliet patoloġiċi kliniċi kienu attribwiti għal infjammazzjoni tal- ġilda jew intestinali, kif innutat hawn fuq.
For some animals, there were no specific clinical observations or histological changes that suggested inflammation.
Għal xi annimali, ma kien hemm l- ebda osservazzjonijiet kliniċi speċifiċi jew bidliet istoloġiċi li ssuġġerixxew infjammazzjoni.
Temsirolimus was not genotoxic in a battery of in vitro (bacterial reverse mutation in Salmonella typhimurium and Escherichia coli, forward mutation in mouse lymphoma cells, and chromosome aberrations in Chinese hamster ovary cells) and in vivo (mouse micronucleus) assays.
Temsirolimus ma kienx ġenotossiku f’ sensiela ta ’ assaġġi in vitro (mutazzjoni reverse batterjali f’ Salmonella typhimurium u Escherichia coli, mutazzjoni forward fiċ- ċelluli tal- limfoma tal- ġrieden, u aberrazzjonijiet tal- kromosoma fiċ- ċelluli ta ’ l- ovarju tal- ħamster Ċiniż, u in vivo (mikronukleu tal - ġrieden).
Carcinogenicity studies have not been conducted with temsirolimus; however, sirolimus, the major metabolite of temsirolimus in humans, was carcinogenic in mice and rats.
Ma sarux studji dwar il- karċinoġeneċità b’ temsirolimus; madankollu, sirolimus, il- metabolit maġġuri ta ’ temsirolimus fil- bnedmin, kien karċinoġeniku fil- ġrieden u fil- firien.
The following effects were reported in mice and/ or rats in the carcinogenicity studies conducted: granulocytic leukaemia, lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.
L- effetti li ġejjin kienu rrappurtati fil- ġrieden u/ jew fil- firien fl- istudji li saru dwar il- karċinoġeneċità: lewkimja granuloċitika, limfoma, adenoma epatoċellulari u karċinoma epatoċellulari, u adenoma testikulari.
Reductions in testicular weights and/ or histological lesions (e. g., tubular atrophy and tubular giant cells) were observed in mice, rats, and monkeys.
Tnaqqis fil- piżijiet testikulari u/ jew leżjonijiet istoloġiċi (eż., atrofija tubulari u ċelluli tubulari ġganti) kienu osservati fil- ġrieden, firien, u xadini.
In rats, these changes were accompanied by a decreased weight of accessory sex organs (epididymides, prostate, seminal vesicles).
Fil- firien, dawn it- tibdiliet kienu akkumpanjati minn tnaqqis fil- piż ta ’ l- organi sesswali aċċessorji (epididimu, prostata, vexxikuli seminali).
In reproduction toxicity studies in animals, decreased fertility and partly reversible reductions in sperm counts were reported in male rats.
Fi studji dwar it- tossiċità fir- riproduzzjoni ta ’ l- annimali, tnaqqis fil- fertilità u tnaqqis parzjalment riversibbli fl - għadd ta ’ l- isperma, kienu rrappurtati fil- firien irġiel.
Exposures in animals were lower than those seen in humans receiving clinically relevant doses of temsirolimus.
L- espożizzjonijiet fl- annimali kienu iktar baxxi minn dawk li kienu osservati fil- bnedmin li kienu qed jirċievu dożi klinikament rilevanti ta ’ temsirolimus.
Anhydrous ethanol all-rac-α -Tocopherol (E 307) Propylene glycol Anhydrous citric acid (E 330)
Anhydrous ethanol all- rac- ά— Tocopherol (E 307) Propylene glycol Anhydrous citric acid (E 330)
Diluent:
Dilwent:
Polysorbate 80 (E 433) Macrogol 400 Anhydrous ethanol
Polysorbate 80 (E- 433) Macrogol 400 Anhydrous ethanol
This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
TORISEL 25 mg/ ml concentrate for solution for infusion must not be added directly to aqueous infusion solutions.
Il- konċentrat TORISEL 25 mg/ ml għal soluzzjoni għall- infużjoni ma tridx tiżdied direttament ma ’ soluzzjonijiet akweji ta ’ l- infużjoni.
Direct addition of TORISEL 25 mg/ ml concentrate to aqueous solutions will result in precipitation of medicinal product.
Iż- żieda diretta ta ’ konċentrat TORISEL 25 mg/ ml ma ’ soluzzjonijiet akweji ser tirriżulta fil- preċipitazzjoni tal- prodott mediċinali.
Always dilute TORISEL 25 mg/ ml concentrate for solution for infusion with the supplied diluent before adding to infusion solutions.
Dejjem iddilwi l- konċentrat TORISEL 25 mg/ ml għal soluzzjoni għall- infużjoni bid- dilwent fornut qabel ma żżidu mas- soluzzjonijiet għall- infużjoni.
TORISEL may only be administered in sodium chloride 9 mg/ ml (0.9%)
TORISEL jista ’ jingħata biss f’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni wara d- dilwizzjoni inizjali tal- konċentrat TORISEL 25 mg/ ml b’ 1. 8 ml ta ’ dilwent li jkun inġibed.
TORISEL, when diluted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl) phthalate extraction (DEHP) from polyvinyl chloride (PVC).
Meta dilwit, TORISEL ikun fih polysorbate 80, li hu magħruf li jżid ir- rata ta ’ l- estrazzjoni ta ’ di - (2- ethylhexyl) phthalate (DEHP) minn polyvinyl chloride (PVC).
This incompatibility has to be considered during the preparation and administration of TORISEL.
Din l- inkompatibilità għandha tiġi kkunsidrata waqt il- preparazzjoni u l- għoti ta ’ TORISEL.
It is important that the recommendations in sections 4.2 and 6.6 be followed closely.
Huwa importanti li r- rakkomandazzjonijiet f’ sezzjonijiet 4. 2 u 6. 6 ikunu segwiti mill- qrib.
PVC bags and medical devices must not be used for the administration of preparations containing polysorbate 80, because polysorbate 80 leaches DEHP from PVC.
Boroż tal- PVC u tagħmir mediku ma jridux jintużaw għall- għoti ta ’ preparazzjonijiet li jkun fihom polysorbate 80, għax polysorbate 80 jerħi DEHP mill- PVC.
After first dilution of TORISEL 25 mg/ ml concentrate with 1.8 ml of withdrawn diluent:
Wara l- ewwel dilwizzjoni tal- konċentrat TORISEL 25 mg/ ml b’ 1. 8 ml ta ’ dilwent li jkun inġibed:
24 hours when stored below 25°C and protected from light.
24 siegħa f’ temperatura taħt il- 25°C sa 24 siegħa u għandu jkun protett mid- dawl.
After further dilution of the concentrate-diluent mixture with sodium chloride 9 mg/ ml (0.9%) solution for injection:
Wara dilwizzjoni addizzjonali tat- taħlita ta ’ konċentrat- dilwent b’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni:
6 hours when stored below 25°C and protected from light.
6 sigħat meta jinħażen f’ temperatura taħt il- 25°C u għandu jkun protett mid- dawl.
For storage conditions of the diluted medicinal product, see section 6.3.
14 Għal kundizzjonijiet tal- ħażna tal- prodott mediċinali dilwit, ara sezzjoni 6. 3.
TORISEL 25 mg/ ml concentrate:
Konċentrat TORISEL 25 mg/ ml:
Clear glass vial (type 1 glass) with butyl rubber stopper and a plastic flip-top closure sealed with aluminum.
Kunjett ta ’ ħġieġ ċar (ħġieġ ta ’ tip 1) b’ tapp tal- lastku tal- butyl u għatu flip- top tal- plastik issiġillat bl - aluminju.
1 vial of 1.2 ml of TORISEL 25 mg/ ml concentrate and 1 vial of 2.2 ml of diluent.
1 kunjett ta ’ 1. 2 ml ta ’ konċentrat TORISEL 25 mg/ ml u 1 kunjett ta ’ 2. 2 ml ta ’ dilwent.
During handling and preparation of admixtures, TORISEL should be protected from excessive room light and sunlight.
Waqt l- immaniġġjar u l- preparazzjoni tat- taħlita, TORISEL għandu jkun protett minn dawl eċċessiv tal- kamra jew tax- xemx.
TORISEL, when diluted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl) phthalate (DEHP) extraction from polyvinyl chloride (PVC).
TORISEL, meta dilwit, ikun fih polysorbate- 80, li hu magħruf li jżid ir- rata tal- estrazzjoni ta ’ di - (2- ethylhexyl) phthalate (DEHP) minn polyvinyl chloride (PVC).
15 Therefore, PVC bags and medical devices must not be used for the preparation, storage and administration of TORISEL solutions for infusions.
Għalhekk, il- boroż tal- PVC u tagħmir mediku m’ għandux jintuża għall- preparazzjoni, ħażna u l- għoti ta ’ soluzzjonijiet għall- infużjoni ta ’ TORISEL.
Bags/ containers that come in contact with TORISEL must be made of glass, polyolefin, or polyethylene.
Boroż/ kontenituri li jmissu ma ’ TORISEL iridu jkunu tal- ħġieġ, tal- polyolefin, jew tal- polyethylene.
Dilution TORISEL 25 mg/ ml concentrate must be diluted with the supplied diluent before administration in sodium chloride infusion.
Dilwizzjoni Il- konċentrat TORISEL 25 mg/ ml irid jiġi dilwit bid- dilwent fornut qabel l- għoti ġo infużjoni ta ’ sodium chloride.
In preparing the solution, the following two-step process must be carried out in an aseptic manner according to local standards for handling cytotoxic/ cytostatic drugs:
Meta tipprepara s- soluzzjoni TORISEL, il- proċess li ġej li fih żewġ passi, irid jitwettaq b’ mod asettiku skont l- istandards lokali dwar l- immaniġġjar ta ’ mediċini ċitotossiċi/ ċitostatiċi:
STEP 1:
PASS 1:
DILUTION OF TORISEL 25 MG/ ML CONCENTRATE WITH THE SUPPLIED DILUENT • Withdraw 1.8 ml of the supplied diluent. • Inject the 1.8 ml of diluent into the vial of TORISEL 25 mg/ ml concentrate which contains 30 mg of temsirolimus (1.2 ml of concentrate). • Mix the diluent and the concentrate well by inversion of the vial.
ID- DILWIZZJONI TAL- KONĊENTRAT TORISEL 25 MG/ ML BID- DILWENT FORNUT • Iġbed 1. 8 ml tad- dilwent fornut. • Injetta l- 1. 8 ml tad- dilwent ġol- kunjett tal- konċentrat TORISEL 25 mg/ ml li jkun fih 30 mg ta ’ temsirolimus (1. 2 ml ta ’ konċentrat). • Ħallat id- dilwent u l- konċentrat tajjeb billi taqleb il- kunjett ta ’ taħt fuq.
Sufficient time should be allowed for air bubbles to subside.
Għandu jitħalla żmien suffiċjenti biex il- bżieżaq ta ’ l- arja jisparixxu.
The solution should be a clear to slightly turbid, colourless to light-yellow to yellow solution, essentially free from visual particulates.
Is- soluzzjoni għandha tkun minn ċara sa ftit imdardra, soluzzjoni minn bla kulur sa safra ċara, li tkun essenzjalment ħielsa minn partikuli viżibbli.
One vial of 1.2 ml of TORISEL 25 mg/ ml concentrate contains 30 mg of temsirolimus: when the 1.2 ml concentrate is combined with 1.8 ml of withdrawn diluent, a total volume of 3.0 ml is obtained, and the concentration of temsirolimus will be 10 mg/ ml.
Kunjett wieħed ta ’ 1. 2 ml ta ’ konċentrat ta ’ TORISEL 25 mg/ ml fih 30 mg ta ’ temsirolimus: meta 1. 2 ml tal- konċentrat jitħallat ma ’ 1. 8 ml ta ’ dilwent li jinġibed, jinkiseb volum totali ta ’ 3. 0 ml, u l - konċentrazzjoni ta ’ temsirolimus ser tkun ta ’ 10 mg/ ml.
The concentrate-diluent mixture is stable below 25°C for up to 24 hours.
It- taħlita konċentrat- dilwent hi stabbli sa 24 siegħa f’ temperatura ta ’ taħt il- 25°C.
STEP 2:
PASS 2:
ADMINISTRATION OF CONCENTRATE-DILUENT MIXTURE IN SODIUM CHLORIDE INFUSION • Withdraw the required amount of concentrate-diluent mixture (containing temsirolimus 10 mg/ ml) from the vial; i. e., 2.5 ml for a temsirolimus dose of 25 mg. • Inject the withdrawn volume rapidly into 250 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to ensure adequate mixing.
L- GĦOTI TAT- TAĦLITA TAL- KONĊENTRAT- DILWENT F’ INFUŻJONI TA ’ SODIUM CHLORIDE • Iġbed l- ammont meħtieġ tat- taħlita ta ’ konċentrat- dilwent (li jkun fiha 10 mg/ ml ta ’ temsirolimus) mill- kunjett; i. e., 2. 5 ml għal doża ta ’ temsirolimus ta ’ 25 mg. • Injetta l- volum li jkun inġibed malajr ġo 250 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni biex ikun żgurat taħlit adegwat.
The admixture should be mixed by inversion of the bag or bottle, avoiding excessive shaking, as this may cause foaming.
15 It- taħlita għandha titħallat billi l- borża jew il- flixkun jinqalbu ta ’ taħt fuq, u jiġi evitat ċaqliq eċċessiv, għax dan jista ’ jikkawża li tifforma r- ragħwa.
The resulting solution should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
Is- soluzzjoni li tirriżulta għandha tiġi eżaminata viżwalment għal frak u tibdil fil- kulur qabel ma tingħata, kull meta s- soluzzjoni u l- kontenitur jippermettu.
The admixture of TORISEL in sodium chloride 9 mg/ ml (0.9%) solution for injection should be protected from excessive room light and sunlight.
It- taħlita ta ’ TORISEL f’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni, għandha tkun protetta minn dawl eċċessiv tal- kamra jew tax- xemx.
• Administration of the final diluted solution should be completed within six hours from the time that the TORISEL is first added to sodium chloride 9 mg/ ml (0.9%) solution for injection.
Kif Jingħata • L- għoti tas- soluzzjoni dilwita finali għandha titlesta fi żmien sitt sigħat mill- ħin li TORISEL l- ewwel ikun żdied ma ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
• TORISEL is infused over a 30- to 60-minute period once weekly.
• TORISEL jingħata bħala infużjoni fuq perijodu ta ’ minn 30 sa 60- minuta darba f’ ġimgħa.
The use of an infusion pump is the preferred method of administration to ensure accurate delivery of the medicinal product.
L- użu ta ’ pompa ta ’ l- infużjoni hu l- metodu ppreferut ta ’ l- għoti biex tiżgura l- forniment preċiż tal- prodott mediċinali.
• Appropriate administration materials must be composed of glass, polyolefin, or polyethylene to avoid excessive loss of medicinal product and to decrease the rate of DEHP extraction.
• Il- materjali adattati ta ’ l- għoti għandhom iridu jkunu magħmula mill- ħġieġ, polyolefin, jew polyethylene biex jiġi evitat telf eċċessiv tal- prodott mediċinali u biex titnaqqas ir- rata ta ’ estrazzjoni ta ’ DEHP.
The administration materials must consist of non-DEHP, non-PVC tubing with appropriate filter.
Il- materjal ta ’ l- għoti jrid ikun jikkonsisti minn non- DEHP, non- PVC b’ filtru adattat.
An in-line polyethersulfone filter with a pore size of not greater than 5 microns is recommended for administration to avoid the possibility of particles bigger than 5 microns being infused.
Filtru in- line tal- polyethersulfone b’ daqs tal- pori ta ’ mhux aktar minn 5 mikrons hu rakkomandat għall- għoti biex tiġi evitata l- possibbiltà li partikuli ta ’ iktar minn 5 microns jiġu infużi.
If the administration set available does not have an in-line filter incorporated, a filter should be added at the end of the set (i. e., an end-filter) before
Jekk is- sett li jkun disponibbli għall- għoti ma jkunx fih filtru in- line inkorporat, għandu jitwaħħal filtru fit- tarf tas- sett (i. e., end- filter) qabel ma t- taħlita tilħaq il- vina tal- pazjent.
Different end-filters can be used ranging in filter pore size from 0.2 microns up to 5 microns.
End- filters differenti jistgħu jintużaw, li jvarjaw fid- daqs tal- pori tal- filtru minn 0. 2 microns sa 5 microns.
The use of both an in-line and end-filter is not recommended.
L- użu kemm ta ’ in- line kief ukoll ta ’ end- filter mhuwiex rakkomandat.
• TORISEL, when diluted, contains polysorbate 80, which is known to increase the rate of DEHP extraction from PVC.
• Meta dilwit, TORISEL ikun fih polysorbate 80, li hu magħruf li jżid ir- rata ta ’ l- estrazzjoni ta ’ DEHP minn PVC.
This should be considered during the preparation and administration of TORISEL following constitution.
Dan il- fatt għandu jiġi kkunsidrat waqt il- preparazzjoni u l- għoti ta ’ TORISEL wara li jkun kostitwit.
It is important that the recommendations in section 4.2 be followed closely.
Huwa importanti li r- rakkomandazzjonijiet f’ sezzjoni 4. 2 jkunu segwiti mill - qrib.
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH United Kingdom
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH Ir- Renju Unit
19 November 2007
19 ta ’ Novembru, 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA): http: // www. emea. europa. eu
Via Franco Gorgone Zona Industriale 95100 Catania Italy
Via Franco Gorgone Zona Industriale 95100 Catania L- Italja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 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 Id- Detentur ta' l- Awtorizzazzjoni tal- Manifattura jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f' verżjoni 1. 0, ippreżentata f' Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta 'l- 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 1.7 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 Id- Detentur ta 'l- Awtorizzazzjoni tal- Manifattura jrid ikun obbligat li jwettaq l- istudji u attivitajiet addizzjonali ta' farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f' verżjoni 1. 7 tal - Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f' Modulu 1. 8. 2. ta 'l - Applikazzjoni ta' l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Flimkien ma 'dan, RMP aġġornat għandu jkun sottomess • Meta informazzjoni ġdida tkun irċevuta li jista' 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
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each vial of 1.2 ml of TORISEL 25 mg/ ml concentrate contains 30 mg temsirolimus.
Kull kunjett ta ’ 1. 2 ml ta ’ konċentrat TORISEL 25 mg fih 30 mg ta ’ temsirolimus.
After first dilution of TORISEL 25 mg/ ml concentrate with 1.8 ml of withdrawn diluent, the concentration of temsirolimus is 10 mg/ ml.
Wara l- ewwel dilwizzjoni tal- konċentrat TORISEL 25 mg/ ml b’ 1. 8 ml ta ’ dilwent li jkun inġibed, il - konċentrazzjoni ta ’ temsirolimus tkun ta ’ 10 mg/ ml.
The other ingredients in the concentrate are:
Is- sustanzi l- oħra fil- konċentrat huma:
Anhydrous ethanol, all-rac-α -tocopherol (E 307), propylene glycol, anhydrous citric acid (E 330).
Anhydrous ethanol, all- rac- a- tocopherol (E 307), propylene glycol, anhydrous citric acid (E 330).
The diluent contains: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
Id- dilwent fih: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
Concentrate and diluent for solution for infusion:
Konċentrat u dilwent għal soluzzjoni għall- infużjoni:
One vial of 1.2 ml TORISEL concentrate for solution for infusion.
Kunjett wieħed ta ’ 1. 2 ml ta ’ konċentrat ta ’ TORISEL għal soluzzjoni għall- infużjoni.
One vial of2.2 ml diluent.
Kunjett wieħed ta ’ 2. 2 ml ta ’ dilwent.
For intravenous use after dilution and administration in infusion.
Użu għal ġol- vini wara li jkun dilwit u l- għoti fl- infużjoni.
The 1.2 ml of concentrate must be diluted with 1.8 ml of withdrawn diluent before administration of the dose in sodium chloride 9 mg/ ml (0.9%) solution for injection.
Il- 1. 2 ml ta ’ konċentrat irid ikun dilwit b’ 1. 8 ml ta ’ dilwent li jkun inġibed qabel l- għoti tad- doża f’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
Read the package leaflet before use and for dilution instructions.
Aqra l- fuljett ta ’ tagħrif qabel l- użu u għall- istruzzjonijiet dwar id- dilwizzjoni..
Contains ethanol.
Fih ethanol.
Read the leaflet for the shelf life of the diluted product.
Aqra l- fuljett għaż- żmien kemm idum tajjeb il- prodott dilwit.
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CONCENTRATE VIAL
24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TORISEL 25 mg/ ml concentrate.
TORISEL 25 mg/ ml konċentrat.
Temsirolimus. i. v. use
Użu għal ġol- vini
DILUTE BEFORE USE.
IDDILWA QABEL L- UŻU.
Store in a refrigerator (2ºC-8ºC)
Aħżen fi friġġ (2ºC- 8ºC)
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS DILUENT VIAL
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Diluent for TORISEL. i. v. use
Dilwent għal TORISEL.
See package leaflet.
Ara l- fuljett ta ’ tagħrif.
2.2 ml.
2. 2 ml.
Contains:
Il- prodott fih:
Polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
Polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
Read all of this leaflet carefully before you are given this medicine.
Aqra sew dan il- fuljett kollu qabel ma tingħata din il- mediċina.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex
What TORISEL is and what it is used for 2.
X’ inhu TORISEL u għalxiex jintuża 2.
Before you receive TORISEL 3.
Qabel ma tirċievi TORISEL 3.
How TORISEL is given 4.
Kif jingħata TORISEL 4.
How to store TORISEL 6.
Kif taħżen TORISEL 6.
WHAT TORISEL IS AND WHAT IT IS USED FOR
X’ INHU TORISEL U GĦALXIEX JINTUŻA
TORISEL is used as an initial treatment for advanced cancer of the kidney.
TORISEL jintuża bħala kura inizjali għal kanċer avvanzat tal- kliewi.
TORISEL is a selective inhibitor of mTOR (mammalian target of rapamycin) that blocks tumour cell growth and division.
TORISEL hu inibitur selettiv ta ’ mTOR (mira mammifera ta ’ rapamycin) li jimblokka t- tkabbir u d - diviżjoni ta ’ ċelluli tat- tumur.
BEFORE YOU RECEIVE TORISEL
QABEL MA TIRĊIEVI TORISEL
Do not use TORISEL
Tużax TORISEL
- If you are allergic (hypersensitive) to temsirolimus, to polysorbate 80 or any of the other ingredients
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal temsirolimus, għal polysorbate 80
of TORISEL
jew sustanzi oħra ta ’ TORISEL
- If you are allergic (hypersensitive) to sirolimus (used to prevent the body from rejecting
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal sirolimus (użat biex ma jħallix il -
transplanted kidneys) since sirolimus is released from temsirolimus in the body.
ġisem jirrifjuta kliewi trapjantati) minħabba li sirolimus jintreħa minn temsirolimus fil- ġisem.
Take special care with TORISEL
Oqgħod attent ħafna b’ TORISEL
- If you are allergic (hypersensitive) to antihistamines or cannot take antihistamines for other medical
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- antistamini jew ma tistax tieħu
reasons.
l- antistamini għal raġunijiet mediċi oħrajn.
- If you have high cholesterol, TORISEL may elevate triglycerides and/ or cholesterol.
- Jekk għandek kolesterol għoli, TORISEL jista ’ jżid it- triglycerides u/ jew il- kolesterol.
This may
Dan
require treatment with lipid-lowering agents (medicine used to reduce cholesterol in the blood).
jista ’ jkun jeħtieġ il- kura b’ mediċini li jbaxxu l- lipidi (mediċina li tintuża biex tnaqqas il - kolesterol fid- demm).
- If you are going to have an operation, if you have had recent major surgery, or if you still have an
- Jekk ser ikollok xi operazzjoni, jekk dan l- aħħar kellek operazzjoni maġġuri, jew jekk għad
unhealed wound following surgery, you should tell your doctor before receiving this medicine, as TORISEL may increase the risk of problems with wound healing.
baqgħalek xi ferita mhix imfejqa wara xi operazzjoni, għandek tgħid lit- tabib tiegħek qabel ma tirċievi din il- mediċina, għax TORISEL jista ’ jżid ir- riskju ta ’ problemi bil- fejqan tal- feriti.
- If you are planning to have a vaccination during treatment with TORISEL, the vaccination may be
- Jekk qed tippjana li ser ikollok xi tilqima matul il- kura b’ TORISEL, it- tilqima tista ’ tkun inqas
less effective.
effettiva.
The use of certain vaccinations should be avoided during treatment with TORISEL.
L- użu ta ’ ċertu tilqim għandu jkun evitat matul il- kura b’ TORISEL.
- If you have a history of kidney failure or kidney problems.
- Jekk għandek storja medika ta ’ insuffiċjenza tal- kliewi jew problemi tal- kliewi.
- If you have a history of liver problems.
- Jekk għandek storja medika ta ’ problemi tal- fwied.
- If you are a child or adolescent under 18 years of age, your doctor will consider the potential benefit
- Jekk inti tifel/ tifla jew adolexxent taħt it- 18- il sena, it- tabib tiegħek ser jikkunsidra l- benefiċċju
to you in relation to any risk.
potenzjali għalik fir- rigward ta ’ kwalunkwe riskju.
- If you are over 65 years of age, you may be more likely to have certain side effects including
- Jekk għandek iktar minn 65 sena, tista ’ tkun aktar suxxettibbli li jkollok ċerti effetti sekondarji
swelling of your face and pneumonia.
li jinkludu nefħa fil- wiċċ u pnewmonja.
- If you have tumours in your brain or spinal cord, or are taking medicines to prevent your blood from
- Jekk għandek tumuri f’ moħħok jew fis- sinsla, jew jekk qed tieħu mediċini biex tevita t- tagħqid
clotting (such as warfarin), you may be more likely to have bleeding into your brain.
tad- demm (bħal warfarin), tista ’ tkun aktar suxxettibbli li jkollok ħruġ tad- demm f’ moħħok.
TORISEL may also
28 TORISEL jista ’ wkoll
- increase blood glucose levels and worsen diabetes mellitus.
- iżid il- livelli tal- glucose fid- demm u jħarrax id- dijabete mellitus.
This may result in the need for insulin
Dan jista ’ jirriżulta fil- ħtieġa
and/ or oral antidiabetic agent therapy.
għall- insulina u/ jew ta ’ terapija orali b’ sustanza kontra d- dijabete.
Tell your doctor if you experience any excessive thirst or increased frequency and quantity of urination.
Għid lit- tabib tiegħek jekk ikollok xi għatx eċċessiv jew żieda fil- frekwenza u l- kwantità ta ’ awrina.
- weaken your immune system; therefore, you may be at risk of getting an infection while you are
- idgħajjef is- sistema immuni tiegħek; għalhekk, inti tista ’ tkun f’ riskju li jkollok infezzjoni waqt li
taking TORISEL.
tkun qed tieħu TORISEL.
- cause shortness of breath, cough, and fever.
- jikkawża qtugħ ta ’ nifs, sogħla, u deni.
Tell your doctor if you experience these symptoms.
Għid lit- tabib tiegħek jekk ikollok xi wieħed minn dawn
- increase the risk of cerebral haemorrhage (bleeding in the brain).
- iżid ir- riskju ta ’ emorraġija ċerebrali (ħruġ ta ’ demm fil- moħħ).
- cause cataracts when taken with interferon-α (a medicine used in the treatment of hepatitis and
- jikkawża katarretti meta jittieħed ma ’ interferon- α( mediċina li tintuża fil- kura ta ’ l- epatite u tal -
cancer).
kanċer).
- cause serious allergic reactions.
- jikkawża reazzjonijiet allerġiċi serji.
Tell your doctor if you experience difficulty in breathing and/ or
Għid lit- tabib tiegħek jekk ikollok diffikultà biex tieħu n- nifs
swelling of the face.
u/ jew ikollok nefħa fil- wiċċ.
Some medicines can interfere with the breakdown or metabolism of TORISEL.
Meta tuża TORISEL ma ’ mediċini oħra Xi mediċini jistgħu jinterferixxu mat- tkissir jew mal- metaboliżmu ta ’ TORISEL.
In particular, you should inform your doctor if you are taking any of the following:
B’ mod partikolari, għandek tinforma lit- tabib tiegħek jekk qed tieħu xi waħda minn dawn il- mediċini li ġejjin:
- protease inhibitors used in the treatment of HIV
- inibituri tal- protease li jintużaw fil- kura ta ’ HIV
- antibiotics (including rifampicin) or antifungal medicines (including ketoconazole) used to treat
- mediċini antibijotiċi (li jinkludu rifampin) jew antifungali (li jinkludu ketoconazole) użati biex
infections
jikkuraw l- infezzjonijiet
- nefazodone or selective serotonin re-uptake inhibitors used to treat depression
- nefazodone jew inibituri selettivi re- uptake ta ’ serotonin li jintużaw biex jikkuraw id- dipressjoni
- anti-epileptic medicines, including carbamazepine, phenytoin and phenobarbital
- mediċini anti- epilettiċi, li jinkludu carbamazepine, phenytoin u phenobartital
- rifabutin used to treat infection in people with HIV and other diseases
- rifabutin li jintuża għall- kura ta ’ infezzjoni f’ nies bl- HIV u b’ mard ieħor
- herbal medicines or natural remedies containing St.
- mediċini li ġejjin mill- ħxejjex jew rimedji naturali li jkun fihom St.
John’ s Wort (Hypericum perforatum) used to
John’ s Wort (Hypericum
treat mild depression
perforatum) jintuża biex jikkura dipressjoni ħafifa
- Angiotensin converting enzyme (ACE)-inhibitors used to treat high blood pressure or other
- Inibituri tal- enzima li tibdel angiotensin (ACE) li jintużaw għall- kura ta ’ pressjoni tad- demm
cardiovascular problems (such as enalapril, ramipril, lisinopril), amphiphilic medicines used to treat heart arrhythmias (such as amiodarone), or statins used to treat high cholesterol
għolja jew problemi kardjovaskulari oħrajn (bħal enalapril, ramipril, lisinopril), mediċini amfifiliċi li jintużaw għall- kura ta ’ arritmiji tal- qalb (bħal amiodarone), jew statins li jintużaw għall- kura ta ’ kolesterol għoli
Using TORISEL with food and drink
Meta tuża TORISEL ma ’ l- ikel u max- xorb
- Grapefruit juice may increase blood concentrations of TORISEL and should be avoided.
- Il- meraq tal- grejpfrut jista ’ jżid il- konċentrazzjonijiet ta ’ TORISEL fid- demm u għandu jkun
Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
TORISEL has not been studied in pregnant women, and it must not be used during pregnancy.
TORISEL ma kienx studjat f’ nisa tqal u ma jridx jintuża waqt it- tqala.
It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving TORISEL.
Hu importanti li tgħid lit- tabib tiegħek jekk inti tqila jew jekk qed tippjana li toħroġ tqila qabel ma ’ tieħu TORISEL.
29 Women of childbearing potential must avoid pregnancy by using an effective method of birth control during treatment with TORISEL.
Nisa li jista ’ jkollhom it- tfal għandhom jevitaw it- tqala billi jużaw kontraċezzjoni effettiva matul il - kura b’ TORISEL.
Men with partners of childbearing potential should use medically acceptable contraception while receiving TORISEL.
Irġiel li għandhom is- sieħba tagħhom li jista ’ jkollha t- tfal, għandhom jużaw kontraċezzjoni li hi medikament aċċettabbli waqt li jkunu qed jirċievu TORISEL.
Women should not breast-feed during treatment with TORISEL, as this medicine may interfere with the growth and development of the baby.
In- nisa m’ għandhomx ireddgħu matul il- kura b’ TORISEL, għax din il- mediċina tista ’ tinterferixxi mat- tkabbir u l- iżvilupp tat- tarbija.
Ask your doctor for advice before breast-feeding your baby, as it is not known if TORISEL passes into breast milk.
Staqsi it- tabib tiegħek għal parir qabel ma tredda ’ lit- tarbija tiegħek, għax m’ huwiex magħruf jekk TORISEL jgħaddix ġol- ħalib tas- sider.
No studies on the ability to drive and use machines have been performed.
29 Sewqan u tħaddim ta ’ magni Ma saru l- ebda studji dwar l- effetti fuq il- ħila li ssuq u tħaddem magni.
However, the very common side effects include feeling or being sick (nausea and vomiting); therefore, it is recommended you do not drive immediately after treatment.
Madankollu, l- effetti sekondarji komuni ħafna jinkludu li tħossok, jew fil- fatt tkun, imqalla ’ (nawseja u rimettar), u għalhekk, hu rakkomandat li ma ssuqx immedjatament wara l- kura.
Important information about some of the ingredients of TORISEL
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ TORISEL Din il- mediċina fiha ethanol (alkoħol), ekwivalenti għal 17. 6 ml ta ’ birra, 7. 3 ml ta ’ nbid f’ kull doża.
Harmful for those suffering from alcoholism.
Jagħmel il- ħsara lil dawk li jbatu mill- alkoħoliżmu.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Għandu jkun ikkunsidrat f’ nisa tqal jew li qed ireddgħu, tfal u gruppi li qegħdin f’ riskju għoli bħal pazjenti b’ mard fil- fwied jew epilessija.
HOW TORISEL IS GIVEN
KIF JINGĦATA TORISEL
TORISEL will always be prepared and given to you by a doctor or another healthcare professional as an intravenous infusion (into your vein).
TORISEL ser ikun dejjem ippreparat għalik u jingħatalek minn tabib jew professjonist fil- qasam tal - kura tas- saħħa bħala infużjoni (fil- vina tiegħek).
TORISEL 25 mg/ ml concentrate must be diluted with 1.8 ml of withdrawn diluent before administration in sodium chloride 9 mg/ ml (0.9%) solution for injection (see dilution instructions at the end of the package leaflet).
Il- konċentrat TORISEL 25 mg/ ml irid ikun dilwit b’ 1. 8 ml ta ’ dilwent li jkun inġibed qabel l - għoti f’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) (ara l- istruzzjonijiet dwar id- dilwizzjoni fit- tmiem tal- fuljett ta ’ tagħrif).
The recommended dose is 25 mg infused (as a drip) over a 30- to 60-minute period once weekly.
Id- doża rakkomandata hi ta ’ 25 mg mogħtija bħala infużjoni (bħala dripp) fuq perijodu ta ’ 30 sa 60 minuta darba f’ ġimgħa.
You should receive an injection of antihistamine (to try to prevent allergic reaction to TORISEL) directly into your vein approximately 30 minutes before your dose of TORISEL.
Inti għandek tirċievi injezzjoni ta ’ antistamina (biex tipprova tevita reazzjoni allerġika għal TORISEL) direttament ġol- vina, madwar 30 minuta qabel id- doża tiegħek ta ’ TORISEL.
Treatment with TORISEL should continue until you are no longer benefiting from therapy or until unacceptable side effects occur.
Il- kura b’ TORISEL għandha tkompli sakemm int ma tkunx qed tibbenefika iżjed mit- terapija, jew sakemm isseħħu effetti sekondarji inaċċettabbli.
If too much TORISEL is given or you miss a dose
Jekk tingħata TORISEL aktar milli suppost jew tinsa tieħu doża
As this medicine is prepared and given by a healthcare professional, it is unlikely you will be given too much.
Minħabba li din il- mediċina tkun ippreparata u tingħata minn professjonist fil- qasam tal- kura tas - saħħa, x’ aktarx li mhux ser tingħata żżejjed minnha.
If you are concerned about this, or think you may have missed a dose, tell your doctor immediately.
Jekk qed tinkwieta dwar dan, jew taħseb li qbiżt xi doża, għid lit- tabib tiegħek immedjatament.
Like all medicines, TORISEL can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, TORISEL jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
30 Very common serious side effects observed in more than 1 in 10 patients treated with TORISEL are:
Efetti sekondarji serji komuni ħafna osservati f’ aktar minn 1 minn kull 10 pazjenti kkurati b’ TORISEL huma:
- Decreased number of white cells in the blood, which may increase your risk of infection.
- Tnaqqis fin- numru ta ’ ċelluli bojod fid- demm, li jistgħu jżidu r- riskju ta ’ infezzjoni.
Common serious side effects observed in more than 1 in 100 patients treated with TORISEL are:
Effetti sekondarji serji komuni osservati f’ aktar minn 1 minn kull 100 pazjenti kkurati b’ TORISEL huma:
- Blood clots in the veins.
- Emboli tad- demm fil- vini.
- Allergic (hypersensitivity)/ infusion reactions (including some life-threatening and rare fatal
- Reazzjonijiet allerġiċi minħabba sensittività eċċessiva/ għall- infużjoni (li jinkludu xi
reactions [rare is less than 1 in 1,000 patients]).
reazzjonijiet li huma ta ’ periklu għall- ħajja u reazzjonijiet rari fatali [rari jfisser inqas minn 1 minn kull 1, 000 pazjent]).
You should inform your doctor immediately if you have symptoms of angioedema, such as swollen face, tongue or pharynx, and difficulty in breathing.
Għandek tinforma lit- tabib tiegħek immedjatament jekk għandek sintomi ta ’ anġjodema bħal wiċċ, ilsien jew larinġi minfuħin, u diffikultà biex tieħu n- nifs.
- Decreased number of cells in the blood, which help the blood to clot.
- Tnaqqis fin- numru ta ’ ċelluli fid- demm, li jgħinu lid- demm jagħqad.
- Pleural effusion (fluid around the lungs).
- Ħruġ ta ’ likwidu mill- plewra (fluwidu madwar il- pulmuni).
The following side effects and frequencies are those that have been seen in patients treated with TORISEL:
30 L- effetti sekondarji u l- frekwenzi li ġejjin huma dawk li kienu osservati f’ pazjenti li kienu kkurati b’ TORISEL:
Very Common side effects occurring in more than 1 in 10 patients are:
Effetti sekondarji komuni ħafna li jseħħu f’ aktar minn 1 minn kull 10 pazjenti huma:
General feeling of weakness, swelling due to fluid retention, pain (including abdominal, back, chest and joint pain), feeling or being sick (nausea and vomiting), diarrhoea, fever, sore throat, sores and inflammation in the mouth and/ or the digestive tract, cough nose bleed, runny nose, rash, itching, nail disorder, acne, dry skin, anorexia, shortness of breath, low levels of potassium in the blood (which may cause muscle weakness), low red blood cell count, high blood sugar, high cholesterol and other blood fats, abscess, infections, urinary tract infections, abnormal kidney function (including kidney failure), change in the sense of taste.
Sensazzjoni ġenerali ta ’ dgħjufija, nefħa minħabba żamma ta ’ fluwidu, uġigħ (li jinkludi wġigħ fiż - żaqq, fid- dahar, fis- sider u fil- gogi), tħossok, jew fil- fatt tkun, imqalla ’ (nawseja u rimettar), dijarea, deni, uġigħ fil- griżmejn, feriti u infjammazzjoni fil- ħalq u/ jew fl- apparat diġestiv, sogħla, ħruġ ta ’ demm mill- imnieħer, imnieħer inixxi, raxx, ħakk, disturbi fid- dwiefer, akne, ġilda xotta, anoreksja, qtugħ ta ’ nifs, livelli baxxi ta ’ potassium fid- demm (li jista ’ jikkawża dgħjufija fil- muskoli), għadd baxx ta ’ ċelluli tad- demm ħomor, livell għoli ta ’ zokkor fid- demm, livell għoli ta ’ kolesterol u xaħmijiet oħrajn fid- demm, axxess, infezzjonijiet, infezzjoni fl- apparat urinarju, funzjoni anormali tal - kliewi (li tinkludi insuffiċjenza tal- kliewi), tibdil fis- sens tat- togħma.
Common side effects occurring in less than 1 out of 10 patients, but more than 1 per 100 patients, are:
Effetti sekondarji komuni li jseħħu f’ anqas minn 1 minn kull 10 pazjent, iżda f’ aktar minn 1 minn kull 100 pazjent, huma:
Gum redness and swelling, mouth pain (including sores inside the mouth), stomach bloating, high blood pressure, redness and swelling of the tissues around the eye, including watery eye disorder, taste loss, redness and swelling of the follicles in the skin, allergic (hypersensitivity) reactions, severe scaling of the skin, and problems with healing after surgery.
Ħmura u nefħa fil- ħanek, uġigħ fil- ħalq (li jinkludi feriti fil- ħalq), stonku minfuħ, pressjoni għolja tad - demm, ħmura u nefħa tal- tessut madwar l- għajnejn, li tinkludi disturb ta ’ għajnejn li jdemmgħu, telf fis- sens tat- togħma, ħmura u nefħa tal- follikuli fil- ġilda, reazzjonijiet allerġiċi (ta ’ sensittività eċċessiva), tqaxxir sever tal- ġilda, u problemi fil- fejqan wara xi operazzjoni.
Blood tests that show changes in the way the liver is working, low levels of phosphate in the blood, increased blood clotting (including thrombosis of the veins, embolism in the lung), upper respiratory infections, pneumonia, interstitial lung disease, decreased number of white blood cells, decreased number of lymphocytes.
Testijiet tad- demm li juru tibdil fil- mod li l- fwied jkun qed jaħdem, livelli baxxi ta ’ phosphate fid - demm, żieda fl- emboli tad- demm (li jinkludu trombożi tal- vini, emboliżmu fil- pulmuni), infezzjonijiet ta ’ l- apparat respiratorju ta ’ fuq, pnewmonja, mard interstizjali tal- pulmuni, tnaqqis fin- numru ta ’ limfoċiti.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 jew lill- ispiżjar tiegħek.
Uncommon side effects occurring in less than 1 out of 100 patients, but more than 1 per 1,000 patients are:
Effetti sekondarji mhux komuni li jseħħu f’ inqas minn 1 minn kull 100 pazjent, iżda f’ iktar minn 1 minn kull 1, 000 pazjent, huma:
Pericardial effusion (fluid around the heart that may require drainage and can affect the pumping of blood).
Ħruġ ta ’ likwidu mill- perikardju (fluwidu madwar il- qalb li jista ’ jkollu bżonn li jitneħħa u li jista jaffettwa l- ippumpjar tad- demm).
HOW TO STORE TORISEL
KIF TAĦŻEN TORISEL TORISEL
31 Do not use TORISEL after the expiry date, which is stated on the vial label and carton.
Tużax TORISEL wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kunjett u fuq il- kaxxa tal- kartun.
The first two numbers indicate the month; the next four numbers indicate the year.
L- ewwel żewġ numri jindikaw ix- xahar; l- erba ’ numri li jmiss jindikaw is- sena.