qanastek/EMEA-V3 huggingface dataset:
3 (1.2) 5 (1.9)
44( 22) 6( 3)
1 (0.4) 0
0( 0) 0( 0)
15 (5.7) 8 (3.1)
Infezzjoni Stomatite
2 (0.8) 0
19( 10) 34( 18)
Motor neuropathy
10( 5) 8( 4)
2(
4( 2) 2( 1)
0.8) 0
1( 1) 0( 0)
27 Combination use in bladder cancer
27 Użu kkombinat f’ kanċer ta ’ l- ovarju
Grade 3 and 4 Adverse Events MVAC versus Gemcitabine plus cisplatin
Avvenimenti Avversi Grad 3 u 4 Carboplatin kontra Gemcitabine flimkien ma ’ carboplatin Numru (%) ta ’ Pazjenti
Number (%) of Patients
Fergħa ta ’ Carboplatin
MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) arm (N=196)
Fergħa ta ’ Gemcitabine
Gemcitabine plus cisplatin arm (N=200)
flimkien ma ’ carboplatin (N=175)
Grade 3
Grad
Grade 3 and 4 Adverse Events Carboplatin versus Gemcitabine plus carboplatin Number (%) of Patients
Grad 3 Grad 4
Carboplatin arm (N=174)
Anemija
Laboratory
10( 5. 7)
Grade 3
4( 2. 3)
Grade 4 Grade 3
39( 22. 3)
2(1.1)
9( 5. 1)
Leucopaenia
Newtropenja
9 (5.1)
19( 10. 9)
Non-laboratory
2( 1. 1)
Haemorrhage
73( 41. 7)
0(0.0) 0(0.0)
50( 28. 6)
3 (1.8)
18( 10. 3) 11( 6. 3)
(0.0)
2( 1. 1) 1( 0. 6)
Febrile neutropaenia
53( 30. 3) 84( 48. 0)
0 (0.0) 0 (0.0)
8( 4. 6) 9( 5. 1)
2(1.1)
Emorraġija Newtropenja bid- deni Infezzjoni mingħajr newtropenja
(0.0)
0( 0. 0) 0( 0. 0) 0( 0)
Infection without neutropaenia
0( 0. 0) 0( 0. 0) 0( 0. 0)
(0.0) (0.0)
3( 1. 8) 2( 1. 1) (0. 0)
1(0.6)
(0. 0) (0. 0) 1( 0. 6)
Sensory neuropathy was also more frequent in the combination arm than with single agent carboplatin
Newropatija sensorjali kienet aktar komuni fil- fergħa kkombinata milli f’ dik ta ’ carboplatin waħdu.
There is no known antidote for overdose of gemcitabine.
4. 9 Doża eċċessiva M’ hemmx antidotu għal doża eċċessiva ta ’ gemcitabine.
Doses as high as 5700 mg/m2 have been administered by intravenous infusion over 30-minutes every 2 weeks with clinically acceptable toxicity.
Dożi li laħqu sa 5700 mg/ m2 ġew mogħtija permezz ta ’ infużjoni minn ġol- vini għal 30 minuta kull ġimgħatejn b’ tossiċitajiet li kienu klinikament aċċettabbli.
In the event of suspected overdose, the patient should be monitored with appropriate blood counts and receive supportive therapy, as necessary.
F’ każ ta ’ suspett ta ’ doża eċċessiva, il- pazjent għandu jiġi mmonitorjat permezz ta ’ l- għadd xieraq taċ- ċelluli tad- demm u jirċievi kura ta ’ appoġġ skond il- bżonn.
Pharmacotherapeutic group: pyrimidine analogues ATC code:
Kategorija farmakoterapewtika: analogi ta ’ pyramidine, Kodiċi ATC:
Its action is phase-specific such that gemcitabine primarily kills cells that are undergoing DNA synthesis (S-phase) and, under certain circumstances, blocks the progression of cells at the junction of the G1/S phase boundary.
Attività ċitotossika f’ kolturi ta ’ celluli Gemcitabine juri effetti ċitotossiċi sinifikanti kontra numru varjat ta ’ ċelluli tumorali kkolturati umani u tal- ġrieden. L- azzjoni tiegħu hu fażi- speċifiku, daqstant li l- aktar ċelluli li gemcitabine joqtol huma dawk li jkunu għaddejjin mis- sintesi tad- DNA (Fażi- S) u taħt ċerti ċirkostanzi, jimblokka l- progressjoni taċ- ċelluli fil- punt fejn jiltaqgħu il- fażi G1/ S.
In vitro, the cytotoxic effect of gemcitabine is dependent on both concentration and time.
In vitro, l- effett ċitotossiku ta ’ gemcitabine huwa dipendenti kemm fuq il- konċentrazzjoni u kemm fuq il- ħin.
Antitumoral activity in preclinical models In animal tumour models, antitumoural activity of gemcitabine is schedule-dependent.
Attività antitumorali f’ mudelli ta ’ qabel l- użu kliniku F’ mudelli ta ’ tumur fil- bhejjem, attività antitumorali ta ’ gemcitabine huwa dipendenti fuq l- iskeda.
When gemcitabine is administered daily, high mortality among the animals but minimal antitumoural activity is observed.
Meta gemcitabine jingħata kuljum, kien hemm mortalità kbira fost il- bhejjem u attività antitumorali minima.
If, however, gemcitabine is given every third or fourth day, it can be administered in non- lethal doses with substantial antitumoural activity against a broad spectrum of mouse tumours.
Iżda jekk gemcitabine jingħata kull tielet jew raba ’ ġurnata, jista ’ jingħata f’ dożi li mhumiex letali iżda b’ attività antitumorali sostanzjali kontra varjetà wiesa ’ ta ’ tumuri tal- ġrieden.
Mechanism of action Cellular metabolism and mechanism of action:
Mod ta ’ kif jaħdem Metaboliżmu ċellulari u mod ta ’ kif jaħdem:
Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is metabolised intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.
Gemcitabine (dFdC), li huwa antimetabolita ta ’ pyrimidine, jiġi metabolizzat ġewwa ċ- ċelluli permezz ta ’ nucleoside kinase, f’ nucleosides diphosphate (dFdCDP) u triphosphate (dFdCTP) attivi.
The cytotoxic effect of gemcitabine is due to inhibition of DNA synthesis by two mechanisms of action by dFdCDP and dFdCTP.
28 tad- DNA permezz taż- żewġ metodi ta ’ azzjoni ta ’ dFdCDP u dFdCTP.
First, dFdCDP inhibits ribonucleotide reductase, which is uniquely responsible for catalysing the reactions that produce deoxynucleoside triphosphates (dCTP) for DNA synthesis.
L- ewwel, dFdCDP, jinibixxi ribonucleotide reductase, li huwa l- uniku risponsabbli biex jikkatalizza r- reazzjonijiet li jipproduċu deoxynucleoside triphosphate (dCTP) għas- sintesi tad- DNA.
Inhibition of this enzyme by dFdCDP reduces the concentration of deoxynucleosides in general and, in particular, dCTP.
L- inibizzjoni ta ’ din l- enzima permezz ta ’ dFdCDP tnaqqas b’ mod ġenerali l- konċentrazzjonijiet tad- deoxynucleosides u b’ mod partikulari ta ’ dCTP.
Second, dFdCTP competes with dCTP for incorporation into DNA (self-potentiation).
Bħala t- tieni ħaġa, dFdCTP jikkompeti ma ’ dCTP biex jiġi inkorporat fid- DNA (isaħħaħ lilu nnifsu)
Likewise, a small amount of gemcitabine may also be incorporated into RNA.
B’ mod simili, ammont żgħir ta ’ gemcitabine jista ’ jiġi inkorporat ukoll fl- RNA.
Thus, the reduced intracellular concentration of dCTP potentiates the incorporation of dFdCTP into DNA.
B’ hekk it- tnaqqis fil - konċentrazzjoni ġewwa ċ- ċelluli ta ’ dCTP isaħħaħ l- inkorporazzjoni ta ’ dFdCTP ġewwa d- DNA.
After gemcitabine is incorporated into DNA, one additional nucleotide is added to the growing DNA strands.
DNA polymerase epsilon m’ għandux il- kapaċità li jelimina lil gemcitabine u li jsewwi l- istrixxi tad- DNA li qegħdin jikbru. Wara li gemcitabine jiġi inkorporat fid- DNA, tiżdied nucleotide waħda ma ’ l- istrixxi tad - DNA li qegħdin jikbru.
After this addition there is essentially a complete inhibition in further DNA synthesis (masked chain termination).
Wara din iż- żieda ikun hemm tista ’ tgħid inibizzjoni totali ta ’ iżjed sintesi tad - DNA (terminazzjoni b’ xebh tal- katina).
After incorporation into DNA, gemcitabine appears to induce the programmed cell death process known as apoptosis.
Wara l- inkorporazzjoni fid- DNA, gemcitabine jidher li jistimula l - proċess ipprogrammat tal- mewt taċ- ċellula magħruf bħala apoptożi.
Clinical data Bladder cancer A randomised phase III study of 405 patients with advanced or metastatic urothelial transitional cell carcinoma showed no difference between the two treatment arms, gemcitabine/cisplatin versus methotrexate/vinblastine/adriamycin/cisplatin (MVAC), in terms of median survival (12.8 and 14.8 months respectively, p=0.547), time to disease progression (7.4 and 7.6 months respectively, p=0.842) and response rate (49.4% and 45.7% respectively, p=0.512).
Tagħrif kliniku Kanċer fil- bużżieqa ta ’ l- awrina Ma kien hemm ebda differenza, fi studju randomised ta ’ fażi III b’ 405 pazjenti b’ karċinoma ta ’ ċellula tranżitorja uroteljali avvanzat jew metastatiku, fiż- żewġ fergħat ta ’ kura gemcitabine/ cisplatin kontra methotrexate/ vinblastine/ adriamycin/ cisplatin (MVAC), f’ termini ta ’ sopravivenza medjana (12. 8 u 14. 8 xhur rispettivament, p=0. 547) żmien għall- progressjoni tal- marda (7. 4 u 7. 6 xhur rispettivament, p=0. 842) u rata ta ’ rispons (49. 4% u 45. 7% rispettivament, p=0. 512).
However, the combination of gemcitabine and cisplatin had a better toxicity profile than MVAC.
Madankollu l- profil ta ’ tossiċità tal- kombinazzjoni gemcitabine u cisplatin kien aħjar minn MVAC.
Pancreatic cancer In a randomised phase III study of 126 patients with advanced or metastatic pancreatic cancer, gemcitabine showed a statistically significant higher clinical benefit response rate than 5-fluorouracil (23.8% and 4.8% respectively, p=0.0022).
Kanċer tal- frixa Fi studju randomised ta ’ fażi IIII b’ 126 pazjenti b’ kanċer tal- frixa avvanzat jew metastatiku, gemcitabine wera rata ta ’ rispons ta ’ benefiċju kliniku statistikament ogħla b’ mod sinifikanti meta mqabbel ma ’ 5- fluorouracil (23. 8% u 4. 8% rispettivament, p=0. 0022).
Also, a statistically significant prolongation of the time to progression from 0.9 to 2.3 months (log-rank p < 0.0002) and a statistically significant prolongation of median survival from 4.4 to 5.7 months (log-rank p < 0.0024) was observed in patients treated with gemcitabine compared to patients treated with 5-fluorouracil.
Ġiet osservata wkoll żieda statistikament sinifikanti fil- ħin għall - progressjoni minn 0. 9 sa 2. 3 xhur (log- rank p < 0. 0002) u żieda statistikament sinifikanti fis- sopravivenza medjana minn 4. 4 sa 5. 7 xhur (log- rank p < 0. 0024) f’ pazjenti kkurati b’ gemcitabine meta mqabbla ma ’ 5 - fluorouracil.
29 Non small cell lung cancer In a randomised phase III study of 522 patients with inoperable, locally advanced or metastatic NSCLC, gemcitabine in combination with cisplatin showed a statistically significant higher response rate than cisplatin alone (31.0% and 12.0%, respectively, p < 0.0001).
Kanċer tal- pulmun mhux b’ ċelluli żgħar Fi studju randomised ta ’ fażi III f’ 522 pazjent b’ NSCLC avvanzat lokalment jew metastatiku u mhux operabbli, gemcitabine flimkien ma ’ cisplatin urew rata ta ’ rispons statistikament ogħla b’ mod sinifikanti meta mqabbla ma ’ cisplatin waħdu (31. 0% u 12. 0%, rispettivament, p < 0. 0001).
A statistically significant prolongation of the time to progression, from 3.7 to 5.6 months (log-rank p < 0.0012) and a statistically significant prolongation of median survival from 7.6 months to 9.1 months (log-rank p < 0.004) was observed in patients treated with gemcitabine/cisplatin compared to patients treated with cisplatin.
Ġiet osservata żieda fiż - żmien għal progressjoni statistikament sinifikanti minn 3. 7 sa 5. 6 xhur (log- rank p < 0. 0012) u żieda statistikament sinifikanti fis- sopravivenza medjana minn 7. 6 xhur għal 9. 1 xhur (log- rank p < 0. 004) f’ pazjenti kkurati b’ gemcitabine/ cisplatin meta mqabbla ma ’ pazjenti kkurati b’ cisplatin.
In another randomised phase III study of 135 patients with stage IIIB or IV NSCLC, a combination of gemcitabine and cisplatin showed a statistically significant higher response rate than a combination of cisplatin and etoposide (40.6% and 21.2%, respectively, p=0.025).
Fi studju ieħor randomised ta ’ fażi III b’ 135 pazjent b’ NSCLC fi stadju IIIB jew IV kombinazzjoni ta ’ gemcitabine u cisplatin urew rata ta ’ rispons statistikament ogħla b’ mod sinfikanti meta mqabbla ma ’ kombinazzjoni ta’ cisplatin u etopside (40. 6% u 21. 2%, rispettivament, p=0. 025).
A statistically significant prolongation of the time to progression, from 4.3 to 6.9 months (p=0.014) was observed in patients treated with gemcitabine/cisplatin compared to patients treated with etoposide/cisplatin.
Ġiet osservata żieda fiż - żmien għal progressjoni statistikament sinifikanti minn 4. 3 sa 6. 9 xhur (p=0. 014) f’ pazjenti kkurati b’ gemcitabine/ cisplatin meta mqabbla ma ’ pazjenti kkurati b’ etoposide/ cisplatin.
In both studies it was found that tolerability was similar in the two treatment arms.
Irriżulta li fiż- żewġ studji t- tollerabbilità kienet simili fiż- żewġ fergħat ta ’ kura.
Ovarian carcinoma In a randomised phase III study, 356 patients with advanced epithelial ovarian carcinoma who had relapsed at least 6 months after completing platinum based therapy were randomised to therapy with gemcitabine and carboplatin (GCb), or carboplatin (Cb).
Karċinoma ta ’ l- ovarji Fi studju randomised ta ’ fażi III, 356 pazjent, b’ karċinoma ta ’ l- ovarji epitiljali avvanzat u li rkadew wara għallinqas 6 xhur minn meta kienu spiċċaw terapija bbażata fuq il- platinum, ġew mogħtija b’ mod arbitrarju jew gemcitabine u carboplatin (GCb), jew carboplatin (Cb).
A statistically significant prolongation of the time to progression of disease, from 5.8 to 8.6 months (log-rank p= 0.0038) was observed in the patients treated with GCb compared to patients treated with Cb.
Ġiet osservata żieda statistikament sinifikanti fiż - żmien għall- progressjoni tal- marda minn 5. 8 sa 8. 6 xhur (log- rank p= 0. 0038) f’ pazjenti kkurati b’ GCb meta mqabbla ma ’ pazjenti kkurati b’ Cb.
Differences in response rate of 47.2% in the GCb arm versus 30.9% in the Cb arm (p=0.0016) and median survival 18 months (GCb) versus 17.3 (Cb) (p=0.73) favoured the GCb arm.
29 fil- fergħa ta ’ Cb (p=0. 0016) u sopravivenza medjana ta ’ 18- il xahar (GCb) kontra 17. 3 (Cb) (p=0. 73) iffavorixxew il- fergħa ta ’ GCb.
Breast cancer In a randomised phase III study of 529 patients with inoperable, locally recurrent or metastatic breast cancer with relapse after adjuvant/neoadjuvant chemotherapy, gemcitabine in combination with paclitaxel showed a statistically significant prolongation of time to documented disease progression from 3.98 to 6.14 months (log-rank p=0.0002) in patients treated with gemcitabine/paclitaxel compared to patients treated with paclitaxel.
Kanċer tas- sider Fi studju randomised ta ’ fażi III, b’ 529 pazjent b’ kanċer tas- sider, lokalment rikorrenti jew metastatiku, inoperabbli u b’ rikadenza wara kimoterapija awżiljarja/ awżiljarja għall- ewwel darba, gemcitabine flimkien ma ’ paclitaxel urew żieda statistikament sinifikanti fiż- żmien għal progressjoni ta ’ mard dokument minn 3. 98 sa 6. 14 xhur (log- rank p=0. 0002) f’ pazjenti kkurati b’ gemcitabine/ paclitaxel meta mqabbla ma ’ pazjenti kkurati b’ paclitaxel.
After 377 deaths, the overall survival was 18.6 months versus 15.8 months (log rank p=0.0489, HR 0.82) in patients treated with gemcitabine/paclitaxel compared to patients treated with paclitaxel and the overall response rate was 41.4% and 26.2% respectively (p= 0.0002).
Wara li mietu 377 pazjent is- sopravivenza totali kienet ta ’ 18. 6 xhur kontra 15. 8 xhur (log rank p=0. 0489, HR 0. 82) f’ pazjenti kkurati b’ gemcitabine/ paclitaxel meta mqabbla ma ’ pazjenti kkurati b’ paclitaxel u r- rata ta ’ rispons in ġenerali kienet ta ’ 41. 4% u 26. 2% rispettivament (p= 0. 0002).
The pharmacokinetics of gemcitabine have been examined in 353 patients in seven studies.
Il- farmakokinetika ta ’ gemcitabine ġiet eżaminata fi 353 pazjent f’ seba ’ studji.
The 121 women and 232 men ranged in age from 29 to 79 years.
Il- 121 mara u 232 raġel kellhom etá li tvarja minn 29 sa 79 sena.
Of these patients, approximately 45% had non-small cell lung cancer and 35% were diagnosed with pancreatic cancer.
Minn dawn il- pazjenti, madwar 45% kellhom kanċer tal- pulmun mhux b’ ċelluli żgħar u 35% kellhom kanċer tal- frixa.
The following pharmacokinetic parameters were obtained for doses ranging from 500 to 2,592 mg/m2 that were infused from 0.4 to 1.2 hours.
Il- parametri farmakokinetiċi li ġejjin ġew miksuba minn dożi li jvarjaw minn 500 sa 2, 592 mg/ m2 u kellhom ħin ta ’ infużjoni li jvarja minn 0. 4 sa 1. 2 sigħat.
Peak plasma concentrations (obtained within 5 minutes of the end of the infusion) were 3.2 to 45.5 µg/ml.
L- ogħla konċentrazzjonijiet fil- plażma (miksuba fi żmien 5 minuti mit- tmiem ta ’ l- infużjoni) kienu 3. 2 sa 45. 5 µg/ ml.
Plasma concentrations of the parent compound following a dose of 1,000 mg/m2/30-minutes are greater than 5 µg/ml for approximately 30-minutes after the end of the infusion, and greater than 0.4 µg/ml for an additional hour.
Wara doża ta ’ 1, 000 mg/ m2/ 30- minuta l- konċentrazzjonijiet fil- plażma tas- sustanza oriġinali huma iżjed minn 5 µg/ ml għal madwar 30 minuta mit- tmiem ta ’ l- infużjoni, u għal siegħa oħra huma iżjed minn 0. 4 µg/ ml.
Distribution The volume of distribution of the central compartment was 12.4 l/m2 for women and 17.5 l/m2 for men (inter-individual variability was 91.9%).
Distribuzzjoni Il- volum ta ’ distribuzzjoni fil- kompartiment ċentrali kien ta ’ 12. 4 l/ m2 għan- nisa u ta ’ 17. 5 l/ m2 għall - irġiel (il- varjabbilità bejn indivdwu u ieħor kienet ta ’ 91. 9%).
The volume of distribution of the peripheral compartment was 47.4 l/m2.
Il- volum ta ’ distribuzzjoni fil- kompartiment periferali kien ta ’ 47. 4 l/ m2.
The volume of the peripheral compartment was not sensitive to gender.
It- tip ta ’ sess m’ għandux effett fuq il- volum tal- kompartiment periferali.
The plasma protein binding was considered to be negligible.
L- ammont ta ’ rbit mal- proteini fil- plażma kien ikkunsidrat negliġibbli.
Half-life:
Half- life:
This ranged from 42 to 94 minutes depending on age and gender.
Din kienet tvarja minn 42 sa 94 minuta skond l- età u s- sess.
Gemcitabine does not accumulate when administered once weekly.
Għall- iskeda rakkomandata ta ’ dożaġġ, gemcitabine għandu jkun kważi kollu eliminat fi żmien 5 sa 11- il siegħa mill- bidu ta ’ l - infużjoni. Ma jkunx hemm akkumulazzjoni ta ’ gemcitabine meta dan jingħata darba fil- ġimgħa.
Intracellular metabolism of gemcitabine produces the gemcitabine mono, di and triphosphates (dFdCMP, dFdCDP and dFdCTP) of which dFdCDP and dFdCTP are considered active.
Metaboliżmu Gemcitabine malajr jiġi metabolizzat permezz ta ’ cytidine deaminase fil- fwied, kliewi, demm u tessuti oħra. Il- metaboliżmu intraċellulari ta ’ gemcitabine jipproduċi il- mono, id- di u t- trifosfati ta ’ gemcitabine (dFdCMP, dFdCDP and dFdCTP) li minnhom dFdCDP u dFdCTP huma kkunsidrati attivi.
These intracellular metabolites have not been detected in plasma or urine.
Dawn il - metaboliti intraċellulari ma ġewx osservati fil- plażma u fl- awrina.
The primary metabolite, 2'-deoxy-2', 2'-difluorouridine (dFdU), is not active and is found in plasma and urine.
Il- metabolita primarja, 2 '- deoxy- 2', 2 '- difluorouridine (dFdU), m’ hijiex attiva u ssibha fil- plażma u fl- awrina.
Excretion Systemic clearance ranged from 29.2 l/hr/m2 to 92.2 /hr/m2 depending on gender and age (inter-individual variability was 52.2%).
Eskrezzjoni It- tneħħija sistemika tvarja minn 29. 2 l/ siegħa/ m2 sa 92. 2 siegħa/ m2 skond is- sess u l- età (il- varjabbilità bejn individwu u ieħor kienet ta ’ 52. 2%).
Clearance for women is approximately 25% lower than the values for men.
It- tneħħija fin- nisa hija madwar 25% inqas mill- valuri ta ’ l - irġiel.
Although rapid, clearance for both men and women appears to decrease with age.
Għalkemm hija mgħaġġla, it- tneħħija kemm għall- irġiel u kemm għan- nisa tidher li tonqos ma ’ l - età.
For the recommended gemcitabine dose of 1000 mg/m2 given as a 30-minute infusion, lower clearance values for women and men should not necessitate a decrease in the gemcitabine dose.
Għad- doża rakkomandata ta ’ gemcitabine ta’ 1000 mg/ m2 mogħti bħala infużjoni għal 30 minuta, valuri aktar baxxi ta ’ tneħħja fin- nisa u fl- irġiel m’ għandux bilfors jagħti lok għal tnaqqis fid- doża.
Urinary excretion:
Eskrezzjoni awrinarja:
Less than 10% is excreted as unchanged drug.
Inqas minn 10% jiġi eliminat bħala mediċina li ma sar ebda tibdil fuqha.
Renal clearance was 2 to 7 l/hr/m2.
Tneħħija renali kienet minn 2 sa 7 l/ siegħa/ m2.
During the week following administration, 92 to 98% of the dose of gemcitabine administered is recovered, 99% in the urine, mainly in the form of dFdU and 1% of the dose is excreted in faeces.
99% fl- awrina, l- iżjed taħt forma ta ’ dFdU u 1% tiġi eliminata fl- ippurgar.
dFdCTP kinetics This metabolite can be found in peripheral blood mononuclear cells and the information below refers to these cells.
30 Il- kinetika ta ’ dFdCTP Din il- metabolita tista ’ ssibha fiċ- ċelluli mononukleari tad- demm periferali u l- informazzjoni t’ hawn taħt tirreferi għal dawn iċ- ċelluli.
Intracellular concentrations increase in proportion to gemcitabine doses of 35-350 mg/ m2/30-minutes, which give steady state concentrations of 0.4-5 µg/ml.
Il- konċentrazzjonijiet intraċellulari jiżdiedu b’ mod proporzjonali ma ’ dożi ta ’ gemcitabine ta ’ 35- 350 mg / m2/ 30- minuta, li jagħtu konċentrazzjonijiet fissi ta ’ 0. 4- 5 µg/ ml.
At gemcitabine plasma concentrations above 5 µg/ml, dFdCTP levels do not increase, suggesting that the formation is saturable in these cells.
Meta l - konċentrazzjoni ta ’ gemcitabine fil- plażma tkun iżjed minn 5 µg/ ml, il- livelli ta ’ dFdCTP ma jiżdidux, dan jissuġġerixxi li f’ dawn iċ- ċelluli din il- forma tkun laħqet is- saturazzjoni tagħha.
Half-life of terminal elimination:
Half- life ta ’ eliminazzjoni terminali:
0.7-12 hours.
0. 7- 12- il siegħa.
dFdU kinetics Peak plasma concentrations (3-15 minutes after end of 30-minute infusion, 1000 mg/m2):
Il- kinetika ta ’ dFdU L- ogħla konċentrazzjonijiet fil- plażma (3- 15- il minuta wara t- tmiem ta ’ 30 minuta ta ’ infużjoni, 1000 mg/ m2):
Trough concentration following once weekly dosing:
L- inqas konċentrazzjoni wara dożaġġ ta ’ darba fil- ġimgħa:
0.07-1.12 µg/ml, with no apparent accumulation.
0. 07- 1. 12 µg/ ml, bla ma deher li kien hemm xi akkumulazzjoni.
Triphasic plasma concentration versus time curve, mean half-life of terminal phase - 65 hours (range 33-84 hr).
Kurva ta ’ konċentrazzjoni fil- plażma trifażiku kontra l- ħin, il- medja tal- half- life tal- fażi terminali - 65 siegħa (marġni ta ’ 33- 84 siegħa).
Formation of dFdU from parent compound:
Formazzjoni ta ’ dFdU mis- sustanza oriġinali:
Mean volume of distribution of central compartment:
Medja tal- volum tad- distribuzzjoni fil- kompartiment ċentrali:
18 l/m2 (range 11-22 l/m2).
18 l/ m2 (marġni 11- 22 l/ m2).
Mean steady state volume of distribution (Vss):
Medja tal- volum tad- distribuzzjoni fiss (Vss):
150 l/m2 (range 96-228 l/m2).
150 l/ m2 (marġni 96- 228 l/ m2).
Tissue distribution:
Distribuzzjoni fit- tessuti:
Extensive.
Estensiva.
Mean apparent clearance:
Medja tat- tneħħija apparenti:
2.5 l/hr/m2 (range 1-4 l/hr/m2).
2. 5 l/ siegħa/ m2 (marġni 1- 4 l/ siegħa/ m2).
All.
Kollha.
Gemcitabine and paclitaxel combination therapy Combination therapy did not alter the pharmacokinetics of either gemcitabine or paclitaxel.
Terapija kkombinata ta ’ gemcitabine u paclitaxel Il- farmakokinetika kemm ta ’ gemcitabine u kemm ta ’ paclitaxel ma tbidlitx minħabba t- terapija kkombinata.
Gemcitabine and carboplatin combination therapy When given in combination with carboplatin the pharmacokinetics of gemcitabine were not altered
Terapija kkombinata ta ’ gemcitabine u carboplatin Il- farmakokinetika ta ’ gemcitabine ma inbidlitx meta ingħata flimkien ma ’ carboplatin.
Renal impairment Mild to moderate renal insufficiency (GFR from 30 ml/min to 80 ml/min) has no consistent, significant effect on gemcitabine pharmacokinetics.
Indeboliment renali Insuffiċjenza renali ħafifa sa moderata (GFR minn 30 ml/ min sa 80 ml/ min) m’ għandha ebda effett konsistenti sinifikanti fuq il- farmakokinetika ta ’ gemcitabine
In repeat-dose studies of up to 6 months in duration in mice and dogs, the principal finding was schedule and dose-dependent haematopoietic suppression which was reversible.
Fi studji b’ dożi ripetuti fil- ġrieden u l- klieb li damu sa 6 xhur, l- aktar skoperta importanti kienet is - suppressjoni ematopoetika li kienet dipendenti fuq l- iskeda u d- dożaġġ u li kienet riversibbli.
31 Gemcitabine is mutagenic in an in vitro mutation test and an in vivo bone marrow micronucleus test.
Gemcatibine huwa mutaġeniku f’ test ta ’ mutazzjoni magħmul in vitro u f’ test ta ’ mikronukleus fil - mudullun magħmul in vivo.
Long term animal studies evaluating the carcinogenic potential have not been performed.
Studji fil- bhejjem fit- tul biex jiġi evalwat il- potenzjal karċiniġeniku ma ġewx magħmula.
In fertility studies, gemcitabine caused reversible hypospermatogenesis in male mice.
Fi studji ta ’ fertilità, gemcitabine kkawża ipospermatoġeneżi riversibbli fil- ġrieden maskili.
No effect on the fertility of females has been detected.
Ma ġie osservat ebda effett fuq il- fertilità tas- sess femminili.
Evaluation of experimental animal studies has shown reproductive toxicity e.g. birth defects and other effects on the development of the embryo or foetus, the course of gestation or peri- and postnatal development.
Evalwazzjoni ta ’ studji sperimentali fuq il- bhejjem urew tossiċità riproduttiva eż. difetti mat- twelid u effetti oħra fuq l- iżvilupp ta ’ l- embriju jew fetu, il- kors ta ’ ġestazzjoni jew żvilupp ta ’ waqt jew wara t - twelied.
Gemzar 200 mg contains:
Gemzar 200 mg fih:
Mannitol (E421) Sodium acetate (E262) Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment)
Mannitol (E421) Sodium acetate (E262) Hydrochloric acid (E507) (għall- aġġustament tal- pH) Sodium hydroxide (E524) (għall- aġġustament tal- pH)
Gemzar 1000 mg contains:
Gemzar 1000 mg fih:
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.
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
L- istabbilità waqt l- użu kemm kimika u kemm fiżika ġiet ippruvata għal 24 siegħa f’ temperatura ta ’ 30°C.
From a microbiological point of view, the product should be used immediately.
Mil- lat mikrobijoloġiku l- prodott għandu jintuża immedjatament.
If not used immediately, in- use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution(and further dilution, if applicable) has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, il - ħinijiet ta ’ ħażna waqt l- użu u l- kundizzjonijiet qabel l- użu huma r- responsabbiltà ta ’ min qed jużah u s - soltu ma jkunux iżjed minn 24 siegħa f’ temperatura ambjentali, sakemm ir- rikostituzzjoni/ dilwizzjoni ma saretx f’ kundizzjonijiet asettiċi kontrollati u validati.
Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.
Soluzzjonijiet ta ’ gemcitabine rikostitwit m’ għandhomx jitqiegħdu fil- friġġ, għax jista ’ jkun hemm il - kristallizzazzjoni.
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna Kunjett mhux miftuħ:
Store below 30°C
Aħżen f’ temperatura taħt 30°C
For storage conditions of the reconstituted medicinal product see section 6.3
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikonstitwit, ara sezzjoni 6. 3
Type I flint glass vials, stoppered with a grey bromobutyl rubber stopper and sealed with an aluminium seal, combined with a polypropylene cap.
Kunjetti tal- ħġieġ taż- żnied tat- tip I, magħluq b’ tapp tal- lastku tal- bromobutyl griż u ssiġilat b’ siġill ta ’ l - aluminju flimkien ma ’ għatu tal- polypropylene.
32 Each pack contains 1 vial
Kull pakkett fih kunjett 1
6.6 Special precautions for disposal and other handling
32 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Handling The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution.
Immaniġġjar Il- prekawzjonijiet normali ta ’ sigurtà għas- sustanzi ċitostatiċi għandhom jiġu osservati waqt il - preparazzjoni u r- rimi tas- soluzzjoni għall- infużjoni.
Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used.
L- immaniġġjar tas- soluzzjoni għall- infużjoni għandu jsir f’ armarju ta ’ siġurtà u għandhom jintużaw ġkieket u ngwanti protettivi.
If no safety box is available, the equipment should be supplemented with a mask and protective glasses.
Jekk m’ hemmx armarju ta ’ sigurtà t- tagħmir għandu jiġi miżjud b’ maskra u nuċċalijiet protettivi.
If the preparation comes into contact with the eyes, this may cause serious irritation.
Jekk is- soluzzjoni tiġi f’ kuntatt ma ’ l- għajnejn, din tista ’ tikkawża irritazzjoni serja.
The eyes should be rinsed immediately and thoroughly with water.
B’ mod immedjat l - għajnejn għandhom jiġu mlaħalħa sew bl- ilma.
If there is lasting irritation, a doctor should be consulted.
Jekk l- irritazzjoni tibqa ’, għandu jiġi msejjaħ tabib.
If the solution is spilled on the skin, rinse thoroughly with water.
Jekk is- soluzzjoni titwaqqa ’ fuq il- ġilda, laħlaħ sew bl- ilma.
Instructions for reconstitution (and further dilution, if performed) The only approved diluent for reconstitution of gemcitabine sterile powder is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative).
L- uniku dilwent approvat għar- rikostituzzjoni tat- trab sterili ta ’ gemcitabine huwa sodium chloride 9 mg/ ml (0. 9%), soluzzjoni għall- injezzjoni (mingħajr preservant).
Due to solubility considerations, the maximum concentration for gemcitabine upon reconstitution is 40 mg/ml.
Minħabba konsiderazzjonijiet ta ’ solubilità, l- ogħla konċentrazzjoni ta ’ gemcitabine fi tmiem ir- rikostituzzjoni hija ta ’ 40 mg/ ml.
Reconstitution at concentrations greater than 40 mg/ml may result in incomplete dissolution and should be avoided.
Jekk ir - rikostituzzjoni issir f’ konċentrazzjonijiet ogħla minn 40 mg/ ml, jista ’ jkun li t- trab ma jkunx inħall sew u dan għandu jiġi evitat.
Use aseptic technique during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration.
Waqt ir- rikostituzzjoni u għal iżjed dilwizzjoni ta ’ gemcitabine għall- għoti ta ’ infużjoni minn ġol - vini uża teknika asettika.
To reconstitute, add 5 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, to the 200 mg vial or 25 ml sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, to the 1000 mg vial.
Irrikostitwixxi l- kunjetti ta ’ 200 mg b’ 5 ml ta ’ 9 mg/ ml (0. 9%) ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride sterili, mingħajr preservanti jew għall- kunjett ta ’ 1000 mg, 25 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride sterili mingħajr preservanti.
The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively.
Il- volum totali wara r - rikostituzzjoni hu ta ’ 5. 26 ml (kunjett ta ’ 200 mg) jew ta ’ 26. 3 ml (kunjett ta ’ 1000 mg) rispettivament.
This yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder.
Dan jagħti konċentrazzjoni ta ’ gemcitabine ta ’ 38 mg/ ml, li jinkludi fih il- volum ta ’ spustament tat- trab lijofilizzat.
Shake to dissolve.
Ħawwad biex jinħall.
Further dilution with sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative can be done.
Tista ’ ssir iżjed dilwizzjoni permezz ta ’ soluzzjoni għall- injezzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride sterili mingħajr preservanti.
Reconstituted solution is a clear colourless to light straw-coloured solution.
Is - soluzzjoni rikostitwita hija ċara u l- kulur ivarja minn bla kulur għal kulur it- tiben ċar.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Qabel ma jiġu mogħtija, prodotti mediċinali għall- użu parenterali għandhom jiġu eżaminati viżwalment għal xi frak jew għal xi tibdil fil- kulur.
If particulate matter is observed, do not administer.
Jekk tara xi frak m’ għandekx tagħtih.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali.
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
34 TIKKETTA
Gemzar 1000 mg powder for solution for infusion Gemcitabine
Gemzar 1000 mg trab għal soluzzjoni għall- infużjoni Gemcitabine
Each vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine.
Kull kunjett fih gemcitabine hydrochloride ekwivalenti għal 200 mg gemcitabine
Each vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine
Kull kunjett fih gemcitabine hydrochloride ekwivalenti għal 1000 mg gemcitabine
Mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.
Mannitol (E421), sodium acetate, hydrochloric acid u sodium hydroxide.
See leaflet for further information.
Ara l- fuljett għal aktar tagħrif..
1 vial, powder for solution for infusion
kunjett 1, trab għal soluzzjoni għall- infużjoni
METHOD AND R OUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
For single use only
Għall- użu minn ġol- vini wara r- rikostituzzjoni Aqra l- fuljett ta ’ tagħrif qabel l- użu Għall- użu ta ’ darba biss
Do not refrigerate the reconstituted solution
Tagħmilx is- soluzzjoni rikostitwita fil- friġġ
Read the leaflet for the shelf life of the reconstituted product
Aqra l- fuljett sabiex tara kemm idum tajjeb il- prodott rikostitwit
Discard unused contents appropriately.
Armi l- affarijiet mhux użati kif suppost
Gemcitabine For intravenous use after reconstitution
Gemzar 1000 mg trab għal soluzzjoni għall- infużjoni
1000 mg gemcitabine
1000 mg gemcitabine
38 PACKAGE LEAFLET:
38 FULJETT TA ’ TAGĦRIF
Gemzar 200 mg powder for solution for infusion Gemzar 1000 mg powder for solution for infusion Gemcitabine
Gemzar 200 mg trab għal soluzzjoni għall- infużjoni Gemzar 1000 mg trab għal soluzzjoni għall- infużjoni
Read all of this leaflet carefully before you start receiving this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tirċievi din il- mediċina
- If you have further questions, please ask your doctor, nurse or pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib, lin- ners jew lill- ispiżjar tiegħek.
What Gemzar is and what it is used for 2.
X’ inhu Gemzar u għalxiex jintuża 2.
Before you are given Gemzar 3.
Qabel ma tingħata Gemzar 3.
How Gemzar is given 4.
Kif jingħata Gemzar 4.
How to store Gemzar 6.
Kif taħżen Gemzar 6.
WHAT GEMZAR IS AND WHAT IT IS USED FOR
X’ INHU GEMZAR U GĦALXIEX JINTUŻA
These medicines kill dividing cells, including cancer cells.
Gemzar jagħmel parti minn grupp ta ’ mediċini li jissejħu “ ċitotossiċi ”. Dawn il- mediċini joqtlu ċelluli li jkunu qed jiddividu inklużi ċ- ċelluli tal- kanċer.
Gemzar may be given alone or in combination with other anti -cancer medicines, depending on the type of cancer.
Skond it- tip ta ’ kanċer, Gemzar jista ’ jingħata waħdu jew flimkien ma ’ mediċini oħra kontra l- kanċer.
Gemzar is used in the treatment of the following types of cancer: • non -small cell lung cancer (NSCLC), alone or together with cisplatin • pancreatic cancer. • breast cancer, together with paclitaxel. • ovarian cancer, together with carboplatin. • bladder cancer, together with cisplatin.
Gemzar jintuża fil- kura ta ’ dawn it- tipi ta ’ kanċer: • kanċer tal- pulmun mhux b’ ċelluli żgħar (NSCLC), waħdu jew flimkien ma ’ cisplatin. • kanċer tal- frixa. • kanċer tas- sider, flimkien ma ’ paclitaxel. • kanċer ta ’ l- ovarji, flimkien ma ’ carboplatin. • kanċer fil- bużżieqa ta ’ l- awrina, flimkien ma ’ cisplatin.
BEFORE YOU ARE GIVEN GEMZAR
QABEL MA TINGĦATA GEMZAR
You should not be given Gemzar:
M’ għandekx tingħata Gemzar:
- if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemzar.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal gemcitabine jew sustanzi oħra ta ’ Gemzar
Take special care with Gemzar:
Oqgħod attent ħafna b’ Gemzar:
Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function.
Qabel l- ewwel infużjoni se jeħdulek kampjuni tad- demm sabiex jaraw jekk il- kliewi u l- fwied humiex jaħdmu b’ mod suffiċjenti.
Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemzar.
Qabel kull infużjoni se jeħdulek kampjuni tad- demm sabiex jaraw jekk għandekx biżżejjed celluli tad- demm biex tirċievi Gemzar.
Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low.
It- tabib tiegħek jista ’ jiddeċiedi li jbiddel id - doża jew jistenna ftit ieħor qabel ma jibda l- kura skond il- kundizzjoni ġenerali tiegħek u jekk l- għadd taċ - ċelluli tad- demm ikun baxx wisq.
Periodically you will have samples of your blood taken to evaluate your kidney and liver function.
Kull tant żmien se jeħdulek kampjuni tad- demm sabiex jaraw kif qed jaħdmu l- kliewi u l- fwied tiegħek.
Please tell your doctor if: • you have, or have previously had liver disease, heart disease or vascular disease. • you have recently had, or are going to have radiotherapy,
40 Jekk jogħġbok għid lit- tabib tiegħek jekk: • għandek, jew kellekx xi darba mard tal- fwied, mard tal- qalb jew mard vaskulari • reċentement ingħatajt jew se tingħata r- radjoterapija • ġejt imlaqqam/ a dan l- aħħar • għandek diffikultà biex tieħu n- nifs jew tħossok għajjien/ a ħafna u inti pallidu/ a ħafna (jista ’ jkun sinjal ta ’ insuffiċjenza tal- kliewi) L- irġiel huma mwissa biex ma jsirux missirijiet waqt u sa 6 xhur wara l- kura b’ gemzar.
Men are advised not to father a child during and up to 6 months following treatment with Gemzar.
Jekk tkun trid li ssir missier waqt il- kura jew sa 6 xhur wara l- kura, ħu parir mingħand it- tabib jew l- ispiżjar tiegħek.
You may want to seek counselling on sperm storage before starting your therapy.
Jista ’ jkun li tkun trid tieħu parir dwar ħażna ta ’ l- isperma qabel ma tibda l- kura tiegħek.
Taking other medicines Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar ta ’ l- isptar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, inkluż tilqim u mediċini miksuba mingħajr riċetta.
Pregnancy and breast-feeding If you are pregnant, or thinking about becoming pregnant, tell your doctor.
Tqala u Treddigħ Jekk inti tqila jew qiegħda taħseb biex toħroġ tqila, għid lit- tabib tiegħek.
The use of Gemzar should be avoided during pregnancy.
L- użu ta ’ Gemzar għandu jiġi evitat waqt it- tqala.
Your doctor will discuss with you the potential risk of taking Gemzar during pregnancy.
It- tabib tiegħek se jiddiskuti miegħek ir- riskju li jista ’ jkun hemm meta tieħu Gemzar waqt it- tqala.
If you are breast-feeding, tell your doctor.
Jekk qed tredda ’ għid lit- tabib tiegħek.
You must discontinue breast-feeding during Gemzar treatment.
Trid twaqqaf it- treddigħ waqt il- kura b’ Gemzar.
Driving and using machines Gemzar may make you feel sleepy, particularly if you have consumed any alcohol.
B’ Gemzar tista ’ tħossok bi ngħas, speċjalment jekk xrobt l- alkoħol.
Do not drive a car or use machinery until you are sure that Gemzar treatment has not made you feel sleepy.
Issuqx karozza jew tħaddem magni sakemm tkun ċert li l- kura b’ Gemzar ma tagħmlekx bi ngħas.
Important information about some of the ingredients of Gemzar Gemzar contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial and 17.5 mg (< 1 mmol) sodium in each 1000 mg vial.
Gemzar fih 3. 5 mg (< 1 mmol) ta ’ sodium f’ kull kunjett ta ’ 200 mg u 17. 5 mg (< 1 mmol) ta ’ sodium f’ kull kunjett ta ’ 1000mg.
To be taken into consideration by patients on a controlled sodium diet.
Trid iżżomm dan f’ moħħok f’ pazjenti li qegħdin fuq dieta kontrollata ta ’ sodium.
HOW GEMZAR IS GIVEN
KIF JINGĦATA GEMZAR
Your height and weight are measured to work out the surface area of your body.
Normalment id- doża ta ’ Gemzar hija ta ’ 1000- 1250 mg għal kull metru kwadru ta ’ l- erja tal- wiċċ tal - ġisem tiegħek.
Your doctor will use this body surface area to work out the right dose for you.
Jieħdulek it- tul u l- piż tiegħek sabiex tinħadem l- erja tal- wiċċ tal- ġisem tiegħek.
This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
It- tabib tiegħek se juża din l- erja tal- wiċċ tal- ġisem sabiex jaħdimlek id- doża adatta għalik. Din id- doża tista ’ tiġi aġġustata jew il- kura posposta skond l- għadd taċ- ċelluli tad- demm u l- kundizzjoni ġenerali tiegħek.
How frequently you receive your Gemzar infusion depends on the type of cancer that you are being treated for.
Kemm- il darba tirċievi l- infużjoni ta ’ Gemzar jiddipendi mit- tip ta ’ kanċer li għalih qed tiġi kkurat/ a.
A hospital pharmacist or doctor will have dissolved the Gemzar powder before it is given to you.
Spiżjar ta ’ l- isptar jew tabib se jkun ħall it- trab ta ’ Gemzar qabel ma jiġi mogħti lilek.
You will always receive Gemzar by infusion into one of your veins.
Dejjem ser tirċievi Gemzar permezz ta ’ infużjoni f’ waħda mill- vini tiegħek.
The infusion will last approximately 30 minutes.
L- infużjoni ser iddum madwar 30 minuta.
Like all medicines, Gemzar can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Gemzar jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
40 • 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 can’t be estimated from the available data
41 Il- frekwenzi li bihom ġew osservati l- effetti sekondarji huma mfissra hekk: • komuni ħafna: jaffettwa aktar minn pazjent 1 minn kull 10 • komuni: jaffettwa minn 1 sa 10 pazjenti minn kull 100 • mhux komuni: jaffettwa minn 1 sa 10 pazjenti minn kull 1, 000 • rari: jaffettwa minn 1 sa 10 pazjenti minn kull 10, 000 • rari ħafna: jaffettwa inqas minn pazjent 1 minn kull 10, 000 • mhux magħruf: il- frekwenza ma tistax tiġi stmata mid- dejta disponibbli
Difficulty breathing (it is very common to have mild breathing difficulty soon after the Gemzar infusion which soon passes, however uncommonly or rarely there can be more severe lung problems)
Trid tikkuntattja lit- tabib tiegħek immedjatament jekk tinduna b’ xi wieħed minn dawn li ġejjin: • Deni jew infezzjoni (komuni): jekk għandek temperatura ta ’ 38°C jew iżjed, qed tegħreq jew xi sinjali oħra ta ’ infezzjoni (għax jista ’ jkollok inqas ċelluli bojod tad- demm min- normal li huwa komuni ħafna) • Il- qalb tħabbat b’ rata irregolari (arritmja) (frekwenza mhux magħrufa) • Uġigħ, ħmura, nefħa jew infafet fil- ħalq (komuni) • Reazzjonijiet allerġiċi: jekk tiżviluppa raxx fil- ġilda (komuni ħafna) / hakk (komuni), jew deni (komuni ħafna) • Għeja, tħossok ħażin, jinqatalek nifsek malajr, jew tidher pallidu/ a (peress li jista ’ jkollok inqas emoglobina min- normal li huwa komuni ħafna) • Demm ħiereġ mill- ħanek, mill- imnieħer jew mill- ħalq jew xi demm ieħor li ma jieqafx, awrina li tagħti fl- aħmar jew fir- roża, tbenġil mhux mistenni (peress li jista ’ jkollok inqas plejtlits min - normal li huwa komuni ħafna) • Diffikultà biex tieħu n- nifs (huwa komuni ħafna li jkollok xi ftit diffikultà biex tieħu n- nifs ftit wara l- infużjoni ta ’ Gemzar iżda din tgħaddi malajr, madankollu b’ mod mhux komuni jew rari jista ’ jkun hemm problemi aktar severi fil- pulmun)
Side effects with Gemzar may include:
Effetti sekondarji b’ Gemzar jistgħu jinkludu:
Very common side effects Low haemoglobin level (anaemia) Low white blood cells Low platelet count Difficulty breathing Vomiting Nausea Skin rash- allergic skin rash, frequently itchy Hair loss Liver problems: found through abnormal blood test results Blood in urine Abnormal urine tests: protein in urine Flu like symptoms including fever Oedema (swelling of ankles, fingers, feet, face)
Effetti sekondarji komuni ħafna Livell baxx ta ’ emoglobina (anemija) Livell baxx ta ’ ċelluli bojod tad- demm Għadd baxx tal- plejtlits Diffikultà biex tieħu n- nifs Rimettar Tqalligħ Raxx fil- ġilda- raxx allerġiku fil- ġilda, ħafna drabi bil- ħakk Twaqqigħ tax- xagħar Problemi fil- fwied: li jinstabu mir- riżultati mhux normali tat- testijiet tad- demm Demm fl- awrina Testijiet ta ’ l- awrina mhux normali: proteini fl- awrina Sintomi li jixbħu dawk ta ’ l- influwneza inkluż id- deni Edima (nefħa fl- għekiesi, swaba ’, saqajn, wiċċ)
Common side effects Fever accompanied by low white blood cell count (febrile neutropaenia) Anorexia (poor appetite) Headache Insomnia Sleepiness Cough Runny nose Constipation Diarrhoea Pain, redness, swelling or sores in the mouth Itching Sweating Muscle pain Back pain Fever Weakness
Effetti sekondarji komuni Deni flimkien ma ’ għadd baxx ta ’ ċelluli bojod tad- demm (newtropenja bid- deni) Anoressija (ma tantx għandek aptit) Uġigħ ta ’ ras Insomnja Ngħas Sogħla Imnieħrek iqattar Stitikezza
41 Chills
42 Dijarea Uġigħ, ħmura, nefħa jew infafet fil- ħalq Ħakk Għaraq Uġigħ fil- muskoli Uġigħ fid- dahar Deni Debbulizza Tregħid
Uncommon side effects Interstitial pneumonitis (scarring of the air sacs of the lung) Spasm of the airways (wheeze) Abnormal chest X ray/scan (scarring of the lungs)
Effetti sekondarji mhux komuni Pulmonite interstizjali (il- boroż żgħar ta ’ l- arja fil- pulmun irabbu qoxra) Spażmu fil- passaġġi ta ’ l- arja (tħarħir) X ray/ ritratt tas- sider mhux normali (il- pulmuni jrabbu qoxra)
Rare side effects Heart attack (myocardial infarction) Low blood pressure Skin scaling, ulceration or blister formation Injection site reactions
Effetti sekondarji rari Attakk tal- qalb (infart mijokardiku) Pressjoni baxxa tad- demm Qxur fil- ġilda, formazzjoni ta ’ ulċeri u nfafet Reazzjonijiet fis- sit ta ’ l- injezzjoni
Very rare side effects Increased platelet count Anaphylactic reaction (severe hypersensitivity/ allergic reaction) Sloughing of skin and severe skin blistering
Effetti sekondarji rari ħafna Żieda fl- għadd tal- plejtlits Reazzjoni anafilattika (reazzjoni ta ’ sensittività eċċessiva / allerġika severa) Ikun hemm tessut mejjet li jaqa ’ minn mal- ġilda u nfafet severi fil- ġilda
Side effects with frequency not known Irregular heart beat (arrhythmia) Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure) Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.
Effetti sekondarji li l- frekwenza tagħhom mhix magħrufa Tħabbit irregolari tal- qalb (arritmja) Sindromu ta ’ Diffikultà Respiratorja ta ’ l- Adulti (infjammazzjoni severa fil- pulmun li tikkawża insuffiċjenza respiratorja) Effetti ta ’ radjazzjoni li tkun ngħatat qabel - (raxx fil- ġilda simili għal dik ta ’ ħarqa severa mix- xemx) li tista ’ sseħ fuq ġilda li xi darba tkun ġiet esposta għar- radjoterapija.
Fluid in the lungs Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply) Heart failure Kidney failure Gangrene of fingers or toes Serious liver damage, including liver failure Stroke
Fluwidi fil- pulmun Tossiċità minħabba radjazzjoni - il- boroż żgħar ta ’ l- arja fil- pulmun irabbu qoxra minħabba t- terapija bir - radjazzjoni Kolite iskemika (infjammazzjoni fit- tessut li jiksi l- intestin il- kbir, minħabba tnaqqis fiċ- ċirkolazzjoni tad - demm) Insuffiċjenza tal- qalb Insuffiċjenza tal- kliewi Is- swaba ’ ta ’ l- idejn u tas- saqajn jikkankraw Ħsara serja fil- fwied inkluż l- insuffiċjenza tal- fwied Puplesija
You might have any of these symptoms and/or conditions.
Jista ’ jkollok xi wħud minn dawn is- sintomi u/ jew kundizzjonijiet.
You must tell your doctor as soon as possible when you start experiencing any of these side effects.
Trid tgħid lit- tabib tiegħek mill- aktar fis possibli jekk tibda tħoss xi wieħed minn dawn l- effetti sekondarji.
If you are concerned about any side effects, talk to your doctor.
Jekk int imħasseb/ a dwar xi effetti sekondarji, tkellem mat- tabib tiegħek.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE GEMZAR
KIF TAĦŻEN GEMZAR
Keep out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx lit- tfal.
Do not use after the expiry date (EXP) which is stated on the carton.
Tużax wara d- data ta ’ skadenza (JIS) li tidher fuq il- kartuna.
Store below 30°C.
Aħżen f’ tempaeratura inqas minn 30°C.