qanastek/EMEA-V3 huggingface dataset:
The efficacy and safety of paclitaxel were evaluated in two major, randomised, controlled trials (vs. cyclophosphamide 750 mg/ m2/ cisplatin 75 mg/ m2).
L- effikaċja u s- sigurtà ta ’ paclitaxel ġew evalwati f’ żewġ provi kliniċi kbar, randomised u kkontrollati (vs cyclophosphamide 750 mg/ m2 / cisplatin 75 mg/ m2).
In the first trial, over 650 patients with stage IIb-c, III or IV primary ovarian cancer received a maximum of 9 treatment courses of paclitaxel (175 mg/ m2 over 3 hours) followed by cisplatin (75 mg/ m2) or control.
Fl- ewwel prova klinika, aktar minn 650 pazjent li kienu jbatu minn kanċer ta ’ l- ovarju primarju li kien jinsab fl- istadji IIb- ċ, III jew IV ġew mogħtija massimu ta ’ 9 korsijiet ta ’ kura ta ’ paclitaxel (175 mg/ m2 mifruxa fuq 3 sigħat) segwit minn cisplatin (75 mg/ m2) jew kontroll.
The second major trial evaluated a maximum of 6 courses of either paclitaxel (135 mg/ m² over 24 hours) followed by cisplatin (75 mg/ m²) or control in over 400 patients with stage III/ IV primary ovarian cancer, with a > 1 cm residual disease after staging laparotomy, or with distant metastases.
Fit- tieni prova klinika ewlenija saret evalwazzjoni massima ta ’ 6 korsijiet jew ta ’ paclitaxel (135mg // m² fuq 24 siegħa) segwit minn cisplatin (75mg / m²) jew kontroll f’ aktar minn 400 pazjent li kienu jinsabu fl- istadju III/ IV tal- kanċer ta ’ l- ovarju, b ’ > 1 ċm ta ’ fdal marradi wara l- laparotomija jew b’ metastasi mbegħda.
Although the two different paclitaxel posologies were not compared with each other directly, in both trials patients treated with paclitaxel in combination with cisplatin had a significantly longer time to progression (Study 1: median 15.3 months vs 11.5 months, p < 0.001; Study 2: median 17 months vs 13 months, p < 0.001), and longer survival time (Study 1: median 36 months vs 26 months, p= 0.0016; Study 2: median 36 months vs 24 months, p < 0.001), and in Study 1 a significantly higher response rate (Study 1:
Għalkemm iż- żewġ pożoloġiji differenti ta ’ paclitaxel ma ġewx paragunati direttament ma ’ xulxin, fiż- żewġ provi kliniċi, pazjenti kkurati b’ paclitaxel flimkien ma ’ cisplatin kellhom perijodu sinifikanti akbar ta ’ tifrix (1el Studju: medjan 15. 3 xhur kontra 11. 5 xhur, p < 0. 001; 2ni Studju: medjan 17- il xahar vs 13- il xahar, p < 0. 001), u perijodu itwal ta ’ sopravivenza (1el Studju: medjan 36 xahar vs 26 xahar, p=0. 0016; 2ni Studju: medjan 36 xahar vs 24 xahar, p < 0. 001), u fl- 1el Studju, rata ta ’ rispons sinifikament ogħla (1el Studju:
59% vs 45%, p= 0.014; Study 2:
59% vs 45%, p=0. 014; 2ni Studju:
60% vs 50%, NS), when compared with standard therapy.
60% vs 50%, NS) meta paragunat mat- terapija standard.
Increased neurotoxicity, arthralgia/ myalgia but reduced myelosuppression were observed in advanced ovarian cancer patients administered 3 hour infusion paclitaxel/ cisplatin as compared to patients who received cyclophosphamide/ cisplatin.
Kienu osservati li kien hemm newrotossiċità u artralġja/ majalġja akbar imma kien hemm inqas trażżin tal- mudullun f’ pazjenti li kienu qed ibatu minn kanċer ta ’ l- ovarju avvanzat u li kienu qed jiġu mogħtija infużjoni ta ’ 3 sigħat b’ paclitaxel/ cisplatin meta paragunati ma ’ pazjenti li rċevew cyclophosphamide / cisplatin.
Metastatic ovarian cancer (second-line treatment):
Kanċer ta’ l- ovarju fl- istat metastatiku (it- tieni kura preferuta):
The efficacy and safety of Paxene (175 mg/ m² over 3 hours repeated at 3-week intervals) in advanced metastatic ovarian cancer were investigated in 120 women in a multicentre, open-label extended Phase II trial.
11 L- effikaċja u s- sigurtà ta ’ Paxene (175 mg/ m² fuq 3 sigħat ripetuti f’ intervalli kull 3 ġimgħat) f’ kanċer ovarjan fl- istat metastatiku avvanzat ġew investigati f’ 120 mara fi prova estiża ta ’ Fażi II, li hi multiċentrali, u bit- tikketta miftuħa.
The clinical response rate was 21.7% (CI:
Ir- rata ta ’ rispons kliniku kienet ta ’ 21, 7% (CI:
14.7 - 31.1%), median time to progression was 4.1 months (CI:
14. 7 - 31. 1%), iż - żmien medjan għal firxa kienet ta ’ 4. 1 xhur (CI:
3.3 - 4.9 months) and the median survival time was 13.4 months (CI:
3. 3 - 4. 9 xhur) u ż- żmien ta ’ sopravivenza medjan kien ta ’ 13. 4 xhur (CI:
11.5 - 15.0 months).
11. 5 - 15. 0 xhur).
The results obtained with Paxene are closely similar to those of published paclitaxel Phase III trials.
Ir- riżultati miksuba b’ Paxene jixbħu ħafna dawk ippublikati ta ’ paclitaxel fil- provi ta ’ Fazi III.
Advanced non-small cell lung carcinoma:
Karsinoma non- small cell lung avvanzata
Efficacy of paclitaxel/ cisplatin combination has been demonstrated in two randomised, controlled trials in patients with locally advanced or metastatic NSCLC.
L- effikaċja u s- sigurtà tal- kombinazzjoni ta ’ paclitaxel/ cisplatin ġiet murija f’ żewġ provi kliniċi randomised u kkontrollati li saru fuq pazjenti li għandhom NSCLC avvanzat lokalment jew fi stadju metastatiku.
In the first study, 332 patients with locally advanced or metastatic NSCLC were randomised to receive cisplatin (80 mg/ m2) in combination with teniposide (100 mg/ m2; n= 166), or cisplatin (80 mg/ m2) and paclitaxel (175 mg/ m2; n= 166).
Fl- ewwel studju, 332 pazjent li jbatu minn NSCLC avvanzat lokalment jew li kien jinsab fi stadju metastatiku kienu magħżula b’ addoċċ biex jirċievu cisplatin (80 mg/ m2) flimkien ma ’ teniposide (100 mg/ m2, n- 166), jew cisplatin (80 mg/ m2) u paclitaxel (175 mg/ m2; n=166).
5.0 months) with cisplatin/ paclitaxel vs cisplatin/ tenoposide.
Ma kienx hemm vantaġġ fis- sopravivenza (9. 5 vs 9. 9 xhur) jew sopravivenza mingħajr ma jkompli jinfirex (5. 1 vs 5. 0 xhur) b’ cisplatin / paclitaxel vs cisplatin/ tenoposide.
26%), lesser overall side effects and improved short term QoL with cisplatin/ paclitaxel vs cisplatin/ tenoposide were considered important results in a palliative population.
Madankollu, ir- rati ta ’ rispons ogħla (37% vs 26%), il - fatt li kien hemm inqas effetti sekondarji u t- titjieb fit- terminu qasir fil- kwalità tal- ħajja b’ cisplatin/ paclitaxel vs cisplatin/ tenoposide kienu kkonsidrati riżultati importanti f’ popolazzjoni paljattiva.
6%).
In- newrotossiċità periferali ta ’ Grad 2 jew 3 kienet osservata b’ mod aktar komuni b’ cisplatin/ paclitaxel (29% vs 6%).
In the second study, 599 patients with stage IIIB or IV disease were randomised to receive cisplatin (75 mg/ m2) and etoposide (100 mg/ m2; n= 200), or cisplatin (75 mg/ m2) and low-dose paclitaxel (135 mg/ m2; n= 198), or cisplatin (75 mg/ m2) and high-dose paclitaxel (250 mg/ m2) with G-CSF (n= 201).
Fit- tieni studju, 599 pazjent bil- marda fi stadju IIIB jew IV kienu magħżula bl- addoċċ biex jircievu cisplatin (75 mg/ m2) u etoposide (100 mg/ m2; n=200) jew cisplatin (75 mg/ m2) u doża baxxa ta ’ paclitaxel (135 mg/ m2; n=198), jew cisplatin (75 mg/ m2) u doża għolja ta ’ paclitaxel (250 mg/ m2) b’ G- CSF (n=201).
Median survival for each paclitaxel-containing arm was not significantly different compared to etoposide/ cisplatin (p= 0.097 and 0.090 for high-dose paclitaxel and low-dose paclitaxel, respectively).
Is- sopravivenza medjana għal kull fergħa ta l- istudju li fih kien hemm paclitaxel ma kienitx sinifikament differenti meta paragunata ma ’ etoposide/ cisplatin (p=0. 097 u 0. 090 għal doża għolja ta ’ paclitaxel u għal doża baxxa ta’ paclitaxel rispettivament).
With respect to progression free survival, highly statistically significant results were noted for the high-dose paclitaxel arm compared to etoposide/ cisplatin (p= 0.007).
Fir- rigward ta ’ sopravivenza mingħajr ma kompla jinfierex, riżultati statistikament sinjifikanti ġew innotati fil- fergħa ta ’ l- istudju fejn ingħatat doża ta ’ paclitaxel għolja meta paragunata ma ’ etoposide/ cisplatin (p=0. 007).
Response rates strongly favoured the paclitaxel-containing arms [13%, 30% and 26% for the etoposide/ cisplatin, high-dose paclitaxel (p < 0.001 vs etoposide/ cisplatin) and low-dose paclitaxel regimens (p= 0.003 vs
Ir- rati ta rispons jiffavoroxxu b’ mod qawwi l- fergħa ta ’ l- istudju fejn ingħata paclitaxel [13%, 30% u 26% għal etoposide/ cisplatin, doża għolja ta ’ paclitaxel (p < 0. 001 vs etoposidecisplatin) u doża baxxa ta ’ reġimeni b’ paclitaxel (p=0. 003 vs etoposide/ cisplatin) rispettivament].
A greater proportion of paclitaxel-treated patients had improvements in short-term QoL.
Proporzjon akbar ta ’ pazjenti kkurati b’ paclitaxel kellhom titjib fil- kwalità tal- ħajja fuq perijodu qasir.
21%).
Madankollu, in - newrotossiċità ta Grad 3 kienet sinifikament aktar komuni fil- fergħa ta ’ l- istudju fejn ingħatat doża għolja ta ’ paclitaxel meta paragunati ma ’ etoposide/ cisplatin (40% vs 21%).
AIDS-related Kaposi’ s sarcoma:
Sarkoma ta Kaposi relatata ma ’ l- AIDS
The efficacy and safety of Paxene were investigated in a single, non-comparative study in 107 patients with advanced KS, previously treated with systemic chemotherapy.
L- effikaċja u s- sigurtà ta ’ Paxene kienu mistħarġa fi studju uniku, mhux komparattiv li sar fuq 107 pazjenti b’ KS avvanzata, li qabel kienu kkurati b’ kemoterapija sistematika.
In the study, the majority of patients were administered granulocyte colony stimulating factor (G-CSF).
Fl- istudju, il- maġġoranza tal- pazjenti ngħataw fattur li jistimula l- iżvillup ta ’ razzez tal- granuloċiti (G- CSF).
The primary endpoint was best tumour response.
L - punt finali prinċipali li kellu jintlaħaq kien l- aħjar rispons tat- tumur.
Patients were given a 3 hour infusion of Paxene 100 mg/ m² administered every 14 days.
Il- pazjenti ngħataw infużjoni ta ’ tlett sigħat ta ’ Paxene 100 mg/ m2 kull erbax- il jum.
Of the 107 patients, 63 patients were considered resistant to liposomal anthracyclines.
Mill- 107 pazjenti, 63 pazjent kienu kkonsidrati reżistenti għal anthracyclines liposomali.
This subgroup of patients is considered to constitute the core efficacy population.
Dan is- sottogrupp ta ’ pazjenti huwa kkonsidrat li jikkostitwixxi l - popolazzjoni ta ’ effikaċja ewlenija
The overall success rate (complete or partial response) after 15 cycles of treatment was 57% (CI 44 – 70%) in liposomal anthracycline-resistant patients.
Ir- rata ta suċċess globali (rispons sħiħ jew parzjali) wara 15- il ċiklu ta ’ kura kienet ta’ 57% (CI 44 – 70%) f’ pazjenti, reżistenti għal anthracycline liposomali.
More than half of the responses were apparent after the first three cycles of treatment.
Aktar min - nofs ir- risponsi dehru wara l - ewwel tlett ċikli ta ’ kura.
In liposomal anthracycline-resistant patients, the response rates were comparable for patients who had never received a protease inhibitor (55.6%) and those who received one at least 2 months prior to treatment with Paxene (60.9%).
F’ pazjenti reżistenti għal anthracycline liposomali, ir- rati ta risponsi kienu paragunabbli ma dawk ta ’ pazjenti li qatt ma ħadu impeditur tal- protease (55. 6%) u dawk li rċevew ta ’ l- anqas wieħed fi żmien xahrejn qabel ma bdiet il- kura b’ Paxene (60. 9%).
The median time to progression in the core population was 468 days (95% CI 257-NE).
12 Iż- żmien medjan għal firxa fil- popolazzjoni ewlenija kien ta ’ 468 jum (95% CI 257- NE).
Median survival for Paxene could not be computed, but the lower 95% bound was 617 days in core patients.
Is - Sopravivenza medjana għal Paxene ma setgħatx tiġi magħduda, imma l- 95% fil- faxxa ta ’ isfel kienet ta ’ 617- il jum fil- pazjenti ewlenin.
Following intravenous administration, plasma concentrations decline in a biphasic or triphasic manner.
Wara l- għoti ġol- vina, il- konċentrazzjonijiet tal- plażma jonqsu b’ mod bifażiku jew trifażiku.
The disposition of paclitaxel is non-linear (concentration dependent) as the systemic exposure increases more than expected following an increase in dosage.
Il - forniment ta ’ paclitaxel m’ huwiex linejari (jiddependi mill- konċentrazzjoni) hekk kif tiżdied l - espozizzjoni sistematika aktar minn dak mistenni wara żieda fid- doża.
Based on in vitro studies, the degree of plasma protein binding has been reported to range from 88 to 98%.
Msejsa fuq studji in vitro, il- grad ta ’ rabta ta ’ proteina fil- plażma ġie rapportat li jinsab fil- firxa ta ’ bejn 88 sa 98%.
In spite of this high protein binding, paclitaxel is widely distributed to tissues.
Minkejja r- rabta qawwija mal- proteina, paclitaxel huwa distribwit sew fit- tessuti.
Metastatic breast cancer:
Kanċer tas- sider f’ istat metastatiku:
Pharmacokinetic parameters of paclitaxel at 175 mg/ m2 given over 3 hours in 13 patients with breast cancer were as follows: maximum concentration (Cmax) was 3,890 ng/ ml, area under the plasma concentration vs. time curve (AUClast) was 14,090 ng·h/ ml and clearance (CL) was 13.3 l/ h/ m2.
Parametri farmakokinetiċi ta ’ paclitaxel f’ doża ta’ 175 mg/ m2 mogħtija fuq perijodu ta ’ tlett sigħat fi 13- il pazjent b’ kanċer tas- sider kienu kif ġej: konċentrazzjoni massima (Cmax) kienet ta ’ 3, 890 ng/ ml, erja taħt il- kurva ta ’ konċentrazzjoni ta ’ plażma kontra ħin (AUClast) kienet ta ’ 14, 090 ng· h/ ml u rata ta ’ eliminazzjoni (CL) kienet ta ’ 13. 3 l/ h/ m2.
Metastatic breast or ovarian cancer:
Kanċer ovarjan jew tas- sider fl- istat metastatiku:
Pharmacokinetic parameters of paclitaxel at 175 mg/ m2 given over 3 hours in 5 patients with breast cancer and 3 patients with ovarian cancer were as follows: maximum concentration (Cmax) was 4,213 ng/ ml, area under the plasma concentration vs. time curve (AUClast) was 12,603 ng·h/ ml and clearance (CL) was 20.4 l/ h/ m2.
Parametri farmakokinetiċi ta ’ paclitaxel f’ doża ta ’ 175 mg/ m2 mogħtija fuq perijodu ta ’ tlett sigħat f’ 5 pazjenti bil- kanċer tas- sider u 3 pazjenti bil- kanċer ovarjan kienu kif ġej: konċentrazzjoni massima (Cmax) kienet ta ’ 4, 213 ng/ ml, erja taħt il- kurva ta ’ konċentrazzjoni fil- plażma kontra ħin (AUClast) kienet ta ’ 12, 603 ng· h/ ml u rata ta ’ eliminazzjoni kienet ta ’ 20. 4 l/ h/ m2.
Renal excretion plays a minor role in the elimination of paclitaxel, less than 10% of the dose has been reported to be excreted in the urine as unchanged drug.
Anqas minn 10% tad- doża ġiet rappurtata li tiġi eliminata fl- awrina fi stat mhux mibdul.
The major elimination pathway is metabolism followed by biliary excretion; in six patients 39% to 87% of an intravenous dose (175 mg/ m2) was excreted in faeces and, on average, only 10% of the dose was excreted as unchanged paclitaxel.
Il- metaboliżmu huwa l- mezz ewlieni segwit b’ eliminazzjoni mill- bili tal- marrara; f’ sitt pazjenti 39% sa 87% tad- doża mogħtija ġol- vina (175 mg/ m2) ġiet eliminata fl- ipurgar u, fuq medja, 10% biss tad- doża ta ’ paclitaxel baqgħet l- istess.
Several metabolites have been detected, but only three of them have been identified:
Diversi metaboliti ġew intraċċati, imma tlieta minnhom biss ġew identifikati:
6 alpha-hydroxypaclitaxel, 3’ -para-hydroxypaclitaxel and 6 alpha, 3’ -para-dihydroxypaclitaxel.
6 alpha - hydroxypaclitaxel, 3 ’ - para- hydroxypaclitaxel u 6 alpha, 3 ’ - para- dihydroxypaclitaxel.
6 alpha-hydroxypaclitaxel is the major component excreted in faeces.
6 alpha - hydroxypaclitaxel huwa l- komponent ewlieni eliminat fl- ippurgar.
In vitro studies have shown that CYP2C8 and 3A4 are involved in the formation of 6 alpha-hydroxypaclitaxel and 3’ -para-dihydroxypaclitaxel, respectively.
Fi studji in vitro ġie muri li CYP2C8 u 3A4 huma involuti fil- formazzjoni ta ’ 6 alpha- hydroxypaclitaxel u 3 ’ - para - dihydroxypaclitaxel, rispettivament.
AIDS-related Kaposi’ s sarcoma:
Sarkoma ta ’ Kaposi relatata ma ’ l- AIDS
12 Following an intravenous dose of 100 mg/ m2 given as a 3 hour infusion to 19 patients with AIDS- related Kaposi’ s sarcoma, the maximum concentrations ranged from 761 to 2,860 ng/ ml (mean 1,530) and average area under the plasma concentration vs. time curve (AUC) was 5,619 ng·h/ ml (range 2,609 - 9,428).
Wara li ngħatat doża ġol- vina ta’ 100 mg/ m2 b’ infużjoni ta ’ 3 sigħat lil 19- il pazjent li jbatu minn sarkoma ta ’ Kaposi relatata ma ’ l- AIDS, il- konċentrazzjonijiet massimi varjaw minn 761 sa 2, 860 ng/ ml (medja 1, 530) u l- erja medja taħt il- konċentrazzjoni tal- plażma kontra l- kurva tal- ħin (AUC) kienet ta ’ 5, 619 ng. h/ ml (medda ta ’ bejn 2, 609 – 9, 428).
Clearance was 20.6 l/ h/ m2 (range 11 - 38) and the volume of distribution was 291 l/ m2 (range 121 - 638).
Ir- rata ta ’ l- eliminazzjoni kienet ta ’ 20. 6 l/ h/ m2 (medda ta ’ bejn 11- 38) u l- volum ta ’ distribuzzjoni kien ta ’ 291 l/ m2 (medda 121 – 638).
The terminal elimination half-life averaged 23.7 hours (range 12 - 33).
Il- half - life terminali għall- eliminazzjoni kienet f’ medja ta 23. 7 sigħat (medda 12- 33).
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Karsinoġenisi, Mutagenisi, Indeboliment tal- Fertilità:
Paclitaxel has been shown to be genotoxic in vivo (micronucleus test in mice), but it did not induce mutagenicity in the Ames test or the Chinese hamster ovary/ hypoxanthine-guanine phosphoribosyl transferase (CHO/ HGPRT) gene mutation assay.
Paclitaxel intwera li hu ġenotossiku in vivo (test mikronucleju fil- ġrieden), imma ma ssensittizzax mutaġeniċità fit- test ta ’ Ames jew fl- assaġġ ta ’ mutazzjoni fil- ġene ta ’ hypoxanthine- guanine phosphoribosyl transferase fl- ovarju tal- ħamster Ċiniż.
The carcinogenic potential of paclitaxel has not been studied.
Il- potenzjal karsinoġeniku ta ’ paclitaxel għadu ma ’ ġiex studjat.
Paclitaxel at low doses of 0.6 mg/ kg/ day was associated with low fertility and foetal toxicity in rats.
Madankollu, paclitaxel jagħmel parti minn kategorija ta ’ sustanzi li minħabba l - mekkaniżmu ta ’ reazzjoni tagħhom huma potenzjalment karsinoġeniċi.
6.
Paclitaxel f’ dożi baxxi ta ’ 0. 6 mg/ kg/ jum kien assoċjat ma ’ fertilità baxxa u tossiċità fil- fetu fil- firien.
Polyethoxylated castor oil, Citric acid (anhydrous), Ethanol (approximately 392 mg/ ml).
Polyethoxylated castor oil, Citric acid (anidru) ethanol (madwar 392 mg/ ml).
Contact of the undiluted concentrate with plasticised PVC equipment or devices used to prepare solutions for infusion is not recommended.
Kuntatt tal- konċentrat mhux mgħammed ma tagħmir jew apparat tal- PVC f’ għamla ta ’ plastik, użati biex jippreparaw soluzzjonijiet għal infużjoni mhux rakkomandat.
In order to minimise patient exposure to the plasticiser DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted Paxene solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
Sabiex titnaqqas l- espożizzjoni tal - pazjent għal plastiċizzur DEHP [di - (2- ethylhexyl) phthalate], li jista ’ jilissa mill- boroż ta ’ infużjoni ta ’ PVC, soluzzjonijiet ta ’ Paxene dilwit għandu jiġi maħżun fi fliexken (ħġieġ, polypropylene) jew boroż tal- plastik (polypropylene, polyolefin) u mogħtija minn settijiet b’ inforra tal- polyethylene.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fin- nuqqas ta ’ studji ta ’ kompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra.
2 years in the unopened vial.
Sentejn fil- fjala mhux miftuħa.
Chemical, physical and microbial stability of unused, undiluted product remaining in the vial has been demonstrated for up to 28 days when stored below 25 °C.
Instab li l- istabbiltà kimika, fiżika u mikrobika ta ’ prodott mhux użat u mhux dilwit li jifdal fil- fjala ntwera li jista ’ jdum sa 28 ġurnata meta maħżun f’ temperatura ta ’ inqas min 25°C.
Other in-use storage times and conditions are the responsibility of the user.
Żminijiet u kundizzjonijiet oħra ta ħażna waqt l- użu huma r- responsabilità ta ’ l- utent.
Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for 24 hours when stored below 25 ºC.
Wara li jkun dilwit, l- istabbiltà kimika u fiżika f’ boroż ta ’ l- infużjoni tal- polypropylene waqt l- użu nstabet li ddum għal mill- anqas 24 siegħa f’ temperatura ta ’ anqas minn 25°C.
From a microbiological point of view, the diluted product should be used immediately.
Mil- lat mikrobijoloġiku, il- prodott dilwit għandu jintuża minnufih.
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 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih, il - ħinijiet ta ’ ħażna waqt l- użu u l- kundizzjonijiet qabel l- użu huma r- responsabbiltà ta ’ l- utent u m’ għandhomx ikunu aktar minn 24 siegħa f’ temperatura ta ’ 2 sa 8°C, kemm- il darba t- tgħammid ikun sar f’ lok fejn il- kundizzjonijiet huma kkontrollati u asettikament ivvalidati.
Do not store above 25 °C.
Taħżinx f’ temperatura ′ l fuq minn 25°C.
Keep container in the outer carton.
Żomm il- kontenitur fil- kartuna ta ’ barra.
30 mg/ 5 ml vial, 100 mg/ 16.7 ml vial, 300 mg/ 50 ml vial packaged in a carton.
Erba ’ daqsijiet ta ’ pakketti huma disponibbli: fjala ta ’ 30 mg/ 5 ml, fjala ta ’ 100 mg/ 16. 7 ml, fjala ta ’ 150 mg/ 25 ml u fjala ta ’ 300 mg/ 50 ml ippakkettjati f’ kartuna.
The Paxene 30 mg vial is a 5 ml clear glass (type I) vial fitted with a flip-off cap.
Il- fjala ta ’ Paxene ta ’ 30 mg hija fjala ta ’ 5 ml ta ’ ħġieġ ċar (tip I) li huwa mwaħħal b’ għatu li jinqala bis- saba ’.
The Paxene 100 mg vial is a 20 ml clear glass (type I) vial fitted with a flip-off cap
Il- fjala ta ’ Paxene ta ’ 100 mg hija fjala ta ’ 20 ml ta ’ ħġieġ ċar (tip I) li huwa mwaħħal b’ għatu li jinqala bis- saba ’.
The Paxene 150 mg vial is a 30 ml clear glass (type I) vial fitted with a flip-off cap.
Il- fjala ta ’ Paxene ta ’ 150 mg hija fjala ta ’ 30 ml ta ’ ħġieġ ċar (tip I) li huwa mwaħħal b’ għatu li jinqala bis- saba ’.
The Paxene 300 mg vial is a 50 ml clear glass (type I) vial fitted with a flip-off cap.
Il- fjala ta ’ Paxene ta ’ 300 mg hija fjala ta ’ 50 ml ta ’ ħġieġ ċar (tip I) li huwa mwaħħal b’ għatu li jinqala bis- saba ’.
6.6 Instructions for use, handling and disposal
14 6. 6 Prekawzjonijiet speċjali għar- rimi
Preparation and administration precautions: paclitaxel is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling Paxene.
Bħal fil- każ ta ’ komposti tossiċi potenzjali oħrajn, għandu jkun hemm attenzjoni fil- maniġġjar ta ’ Paxene.
The use of gloves, goggles and protective clothing is recommended.
Huwa rakkomandat li jintużaw ingwanti, gogils u ilbies protettiv.
If Paxene solution contacts the skin, wash the skin immediately and thoroughly with soap and water.
Jekk is- soluzzjoni ta ’ Paxene tagħmel kuntatt mal- ġilda, aħsel sew il- ġilda b’ sapun u ilma.
If Paxene contacts mucous membranes, the membranes should be flushed thoroughly with water.
Jekk Paxene tagħmel kuntatt mar- riti mukużi, il- membrani għandhom jitlaħalħu sew bl- ilma.
Paxene should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Paxene għandu jitħejja u jingħata biss minn personal imħarreġ b’ mod xieraq fil- ġestjoni ta ’ l- aġenti ċitotossiċi.
Pregnant staff should not handle Paxene.
Nisa tqal m’ għandhomx imissu Paxene.
Preparation for intravenous infusion:
Preparazzjoni għal infużjoni ġol- vina:
Paxene concentrate for solution for infusion must be diluted prior to infusion.
Il- konċentrat Paxene għal soluzzjoni għal infużjoni għandu jiġi mgħammed qabel l- infużjoni.
Paxene should be diluted in 0.9% w/ v sodium chloride solution for infusion, 5% glucose solution for infusion, or 5% glucose in Ringer’ s solution for infusion to a final concentration of 0.3 to 1.2 mg/ ml.
Paxene għandu jiġi dilwit f’ 0. 9% w/ v klorur tas- sodju għall- infużjoni, 5% soluzzjoni ta ’ glukows għall- infużjoni, jew 5% soluzzjoni ta ’ Ringer fil- glukows għal konċentrat finali ta ’ 0. 3 sa 1. 2 mg/ ml.
Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for at least 24 hours below 25 °C.
Wara li jkun dilwit, l- istabbilità kimika u fiżika fil- boroż ta ’ l- infużjoni tal - polypropylene waqt l- użu nstabet li ddum għal mill- anqas 24 siegħa f’ temperatura ta ’ anqas minn 25°C.
From a microbiological point of view, the diluted product should be used immediately.
Mil- lat mikrobijoloġiku l- prodott dilwit għandu jintuża minnufih.
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 2 to 8° C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih il - ħinijiet ta ’ ħażna u l- kundizzjonijiet qabel l- użu huma r- responsabbiltà ta ’ l- utent u m’ għandhomx ikunu ta ’ aktar minn 24 siegħa f’ temperatura ta ’ 2 sa 8°C, kemm- il darba t- tgħammid ikun sar f’ kundizzjonijiet ikkontrollati u asettikament validati.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Prodotti mediċinali parenterali għandhom jiġu spezzjonati viżwalment għal frak u tibdil fil- kulur qabel ma jingħataw.
Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle.
Waqt il- preparazzjoni, soluzzjonijiet jistgħu jidhru mdardra, u dan minħabba l- mod ta ’ taħlit.
Paxene solutions should be prepared and stored in glass, polypropylene, or polyolefin containers.
Soluzzjonijiet ta ’ Paxene għandhom jiġi ppreparati u maħżuna f’ reċipjenti tal- ħġieġ, polypropylene jew polyolefin.
Non- PVC containing administration sets, such as those which are polyethylene-lined, should be used.
Għandhom jiġu wżati settijiet ta ’ amministrazzjoni li ma fihomx PVC, bħal dawk inforrati b’ polyethylene.
Paxene should be administered through an in-line filter with a microporous membrane not greater than 0.22 µm.
Paxene għandu jiġi mogħti f’ filtru b’ membrana mikroporuża li mhix akbar minn 0. 22 µm.
Use of filter devices such as those which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.
L- użu ta ’ tagħmir li jiffiltra bħal dak li jinkorpora bokka qasira u żbokk ta ’ pajpijiet miksija bil- PVC ma rriżultatx f’ lissi sinifikanti ta ’ DEHP.
Handling and disposal: procedures for proper handling and disposal of cytotoxic medicinal products should be followed.
Maniġġjar u rimi: għandhom jiġu segwiti l- proċeduri xierqa għal maniġġjar u rimi ta ’ prodotti mediċinali ċitotossiċi.
Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom
Norton Healthcare Limited Albert Basin Royal Docks Londra E16 2QJ Renju Unit
MARKETING AUTHORISATION NUMBER(S)
NUMRI TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
EU/ 1/ 99/ 113/ 001-002 for 30 mg/ 5 ml and 150 mg/ 25 ml EU/ 1/ 99/ 113/ 003-004 for 100 mg/ 16.7 ml and 300 mg/ 50 ml
EU/ 1/ 99/ 113/ 001- 002 għal 30 mg/ 5 ml u 150 mg/ 25 ml EU/ 1/ 99/ 113/ 003- 004 għal 100 mg/ 16. 7 ml u 300 mg/ 50 ml
19th July 1999.
19 ta ’ Lulju 1999.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
IVAX Pharmaceuticals UK (Runcorn, Cheshire), Aston Lane North Preston Brook Runcorn, Cheshire, United Kingdom
IVAX Pharmaceuticals UK (Runcorn, Cheshire) Aston Lane North Preston Brook Runcorn Cheshire Renju Unit
Ostravská 29/ 305 747 70 Opava – Komárov Czech Republic
Ostravská 29/ 305 747 70 Opava - Komárov Ir – Repbblika Ċeka
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ SID L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
Medicinal product subject to restricted medical prescription (see Annex I:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (ara Anness I:
•
• KUNDIZZJONIJIET OĦRA
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Sid ta ’ din l- awtorizzazzjoni għall- kummerċ għandu jagħti tagħrif lill- Kummissjoni Ewropea dwar il - pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
The MAH should continue to submit PSURs on a yearly basis.
Rapporti Perjodíċi Aġġornati dwar is- Sigurtà:
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
TIKKETTA
CARTON TEXT FOR PAXENE 30 mg/5 ml
KITBA FUQ IL- KARTUNA GĦAL PAXENE 30 mg/ 5ml
Paxene 6 mg/ml concentrate for solution for infusion (paclitaxel)
Paxene 6mg/ ml konċentrat għal soluzzjoni għall- infużjoni (paclitaxel)
Active ingredient: paclitaxel 6 mg/ml (30 mg/5 ml)
Sustanza attiva: paclitaxel 6mg/ ml (30 mg/ 5 ml)
Also contains: polyoxyl castor oil; citric acid (anhydrous) and 49.7% (v/v) ethanol
Fih ukoll: castor oil polyoxyl; citric acid (anidru) u 49. 7% (v/ v) ethanol
Concentrate for solution for infusion, 6 mg/ml
Konċentrat għal soluzzjoni għall- infużjoni, 6mg/ ml
Diluted product to be delivered by intravenous infusion.
Prodott dilwit li għandu jingħata b’ infużjoni ġol- vina.
CAUTION: dilution required.
Meħtieġ li jiġi dilwit.
Expiry Date:
JIS:
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
Discard any unused contents according to standard practice for cytotoxic agents.
Armi kull prodott mhux użat b’ mod konformi mal- prattika standard għal aġenti ċitotossiċi.
Norton Healthcare Limited Albert Basin, Royal Docks London E16 2QJ UK
Norton Healthcare Limited Albert Basin, Royal Docks Londra E16 2QJ Renju Unit
MARKETING AUTHORISATION NUMBER(S)
NUMRU TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
Batch Number:
Lott:
Please read enclosed package leaflet.
Jekk jogħġbok aqra l- fuljett ta ’ tagħrif li jinsab ġewwa.
VIAL TEXT FOR PAXENE 30 mg/5 ml
KITBA FUQ IL- FJALA GĦAL PAXENE 30mg/ 5ml
Paxene 6 mg/ml concentrate for solution for infusion (paclitaxel)
Paxene 6 mg/ ml konċentrat għal soluzzjoni għall- infużjoni (paclitaxel)
Intravenous use Read the package leaflet before use
Għal użu ġol- vina Aqra l- fuljett ta ’ tagħrif qabel tuża.
Batch Number:
[numru]
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA ’ DAN FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
CARTON TEXT FOR PAXENE 100 mg/16.7 ml
KITBA FUQ IL- KARTUNA GĦAL PAXENE 100 mg/ 16. 7 ml
Active ingredient: paclitaxel 6 mg/ml (100 mg/16.7 ml)
Sustanza attiva: paclitaxel 6mg/ ml (100 mg/ 16. 7 ml)
Concentrate for solution for infusion, 6 mg/ml
Konċentrat għal soluzzjoni għall- infużjoni 6 mg/ ml
Please read the enclosed package leaflet.
Jekk jogħġbok aqra l- fuljett ta ’ tagħrif li jinsab ġewwa.
VIAL TEXT FOR PAXENE 100 mg/16.7 ml
KITBA FUQ IL- FJALA GĦAL PAXENE 100 mg/ 16. 7 ml
Intravenous use.
Użu ġol- vina.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel ma ’ tuża.
100 mg/16.7 ml
100 mg/ 16. 7 ml
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA ’ DAN FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
CARTON TEXT FOR PAXENE 150 mg/25 ml
KITBA FUQ IL- KARTUNA GĦAL PAXENE 150mg/ 25ml
Active ingredient: paclitaxel 6 mg/ml (150 mg/25 ml)
Sustanza attiva: paclitaxel 6mg/ ml (150 mg/ 25 ml)
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET TA ’ ĦAŻNA SPEĊJALI
27 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT FOR PAXENE 150 mg/25 ml
KITBA FUQ IL- FJALA GĦAL PAXENE 150mg/ 25ml
Intravenous use.
Għal użu ġol- vina.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel ma tuża.
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA ’ DAN FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
CARTON TEXT FOR PAXENE 300 mg/50 ml
KITBA FUQ IL- KARTUNA GĦAL PAXENE 300 mg/ 50 ml
Active ingredient: paclitaxel 6 mg/ml (300 mg/50 ml)
Sustanza attiva: paclitaxel 6mg/ ml (300 mg/ 50 ml)
Concentrate for solution for infusion, 6 mg/ml
Konċentrat għal soluzzjoni għall- infużjoni, 6 mg/ ml
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAħAQX U MA JIDHIRX MIT- TFAL
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA JEKK MEĦTIEĠA
Please read the enclosed package leaflet.
Jekk jogħġbok aqra l- fuljett ta ’ tagħrif li jinsab fil- pakkett.
30 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT FOR PAXENE 300 mg/50 ml
KITBA FUQ IL- FJALA GĦAL PAXENE 300 mg/ 50 ml
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif li jinsab ġol- pakkett.
Batch Number:
Lott [numru]
32 PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
Paxene 6 mg/ml Concentrate for Solution for Infusion Paclitaxel
Paxene 6mg / ml Konċentrat għal Soluzzjoni għall- Infużjoni Paclitaxel
Read all of this leaflet before you start using this medicine:
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
- Keep this leaflet safe as you may need to read it again.
Jista ’ jkollok bżonn terġa taqrah.
It
TAGĦTIHIEX lil persuni oħra.
may harm them, even if their symptoms are the same as yours.
Tista ’ tagħmilhom il- ħsara,
In this leaflet:
anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Paxene is and what it is used for 2.
X’ inhu Paxene u għalxiex jintuża 2.
Before you use Paxene 3.
Qabel ma tieħu Paxene 3.
How to use Paxene 4.
Kif tieħu Paxene 4.
Possible side effects 5 Storing Paxene 6.
X’ effetti oħra jista ’ jkollu 5.
Further information
Kif taħżen Paxene 6.
Each ml of the concentrate contains:
Aktar tagħrif
• paclitaxel 6 mg as active substance (equivalent to 30 mg/5 ml or 100 mg/16.7 ml or 150 mg/25 ml or 300 mg/50 ml) and • polyoxyl (polyethoxylated) castor oil, citric acid (anhydrous) and ethanol as inactive ingredients.
Kull ml ta ’ konċentrat fih: • paclitaxel 6 mg bħala s- sustanza attiva (ekwivalenti għal 30 mg/ 5 ml jew 100 mg/ 16. 7 ml jew 150 mg/ 25 ml jew 300 mg/ 50 ml) u • castor oil polyoxyl (polyethoxylated), citric acid (anidru) u ethanol bħala sustanzi mħux attivi.
is Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom.
Sid l- Awtorizzazzjoni għall- Kummerċ huwa Norton Healthcare Limited, Albert Basin, Royal Docks, Londra E16 2QJ, Renju Unit.
is IVAX Pharmaceuticals s.r.o.,,Ostravská 29/305, 747 70 Opava – Komárov, Czech Republic and IVAX Pharmaceuticals UK (Runcorn, Cheshire), Runcorn, Cheshire, United Kingdom.
Il- manifattur hu IVAX Pharmaceuticals s. r. o., Opava - Komárov, Ir – Repbblika Ċeka u IVAX Pharmaceuticals UK (Runcorn, Cheshire), Runcorn, Cheshire, Renju Unit.
WHAT PAXENE IS AND WHAT IT IS USED FOR
X’ INHU PAXENE U GĦALXIEX JINTUŻA
Your concentrate for solution for infusion is called Paxene.
Il- konċentrat għal soluzzjoni għall- infużjoni tiegħek jismu Paxene.
The common name of the active substance is paclitaxel.
L- isem komuni tas- sustanza attiva huwa paclitaxel.
It is part of a group of medicines known as antineoplastic agents.
Huwa jagħmel parti minn grupp ta ’ mediċini magħrufa bħala aġenti anti- nejoplastiċi.
These agents are used to treat cancer.
Dawn l- aġenti jintużaw biex jittrattaw kanċer.
Paxene is a clear, colourless to slightly yellow, thickish solution which comes in vials containing 5 ml, 16.7 ml, 25 ml and 50 ml of concentrate.
Hi tiġi fi fjali ta ’ konċentrat li fihom 5 ml, 16. 7 ml, 25 ml u 50 ml.
Paxene concentrate for solution for infusion is used to treat: • advanced AIDS-related Kaposi’s sarcoma when certain other treatments (liposomal anthracyclines) have been tried but have not worked.
Il- konċentrat Paxene għal soluzzjoni għall- infużjoni huwa intiż biex jikkura: • sarkoma ta ’ Kaposi avvanzata relatata ma ’ l- AIDS meta mediċini speċifiċi oħrajn li ġew ippruvati (anthracyclines liposomali) ma jkunux ħadmu.
This is a tumour that arises from blood vessels in the skin or internal organs and typically appears as flat or raised, purple to dark brown patches on the skin. • advanced breast cancer when certain other treatments (standard anthracycline-containing therapy) have been tried but have not worked or when the patient is unsuitable for these treatments. • advanced ovarian cancer or remaining tumour (> 1 cm) after initial surgery, in combination with cisplatin as first-line treatment.
Dan hu tumur li joħroġ mill- vażi tad - demm fil- ġilda jew l- organi interni u ġeneralment jidher bħala rqajja ’ ċatti jew mogħlija, ta ’ lewn vjola jew kannella skur fuq il- ġilda. • kanċer tas- sider fl- istadju avvanzat meta mediċini speċifiċi oħrajn (terapija standard li fiha anthracycline) ippruvati jkunu fallew u ma ħadmux jew meta l- pazjent ma jkunx tajjeb għal dawn it- trattamenti. • kanċer ta ’ l- ovarju fi stadju avvanzat jew meta jibqa ’ il- fdal ta ’ tumur (> 1ċm) wara l - l- ewwel intervent kirurġiku, li jingħata flimkien ma ’ cisplatin bħala l- kura preferuta. • kanċer ta ’ l- ovarju fl- istadju avvanzat meta mediċini speċifiċi oħrajn (terapija kombinata li fiha l- platinu mingħajr taxanes) ġew ippruvati imma ma ħadmux (bħala t- tieni kura preferuta). • kanċer non- small cell lung (NSCLC) avvanzat jekk il- kura kirurġika u/ jew terapija ta ’ radjazzjoni, mhumiex possibbli, u tingħata flimkien ma ’ cisplatin.
There is limited information to support treatment of this condition.
Hemm tagħrif ristrett li jissostanza l- kura ta ’ din il- kondizzjoni.
BEFORE YOU USE PAXENE
QABEL MA TIEĦU PAXENE
• if you are hypersensitive (allergic) to paclitaxel or any of the other ingredients of Paxene; • if you have ever had any problems with your liver; • if you have been told that your white blood cell count is very low; • if you have a serious, uncontrolled infection; • if you are pregnant, may become pregnant or are breast-feeding.
Tieħux Paxene: • jekk tbati minn sensittività eċċessiva (allerġija) għal paclitaxel jew għal sustanzi oħra ta ’ Paxene; • jekk qatt kellek xi problemi bil- fwied; • jekk qalulek li l- għadd ta ’ ċelluli bojod fid- demm tieħek huwa baxx ħafna; • jekk għandek xi infezzjoni serja, mhux ikkontrollata; • jekk inti tqila, tista ’ tinqabad tqila jew qed tredda ’.
• Before you start treatment with Paxene and during treatment you will have regular blood tests, to check that it is safe for you to continue with your treatment. • Paxene is not recommended for use in children (under 18 years). • Tell your doctor immediately if you develop severe or prolonged or bloody diarrhoea during or after treatment with Paxene.
Oqgħod attenta ħafna b’ Paxene: • Qabel ma tibda l- kura b’ Paxene u waqt it- trattament ser ikollok testijiet ta ’ demm b’ mod regolari sabiex jiġi vverifikat li jkun sikur għalik li tissokta bit- trattament tiegħek. • Paxene mhux rakkomandat għal użu fi tfal (taħt 18- il sena). • Għid lit- tabib tiegħek minnufih jekk ikollok dijarrea serja jew fit- tul jew wara trattament b’ Paxene.
This may be a sign of a serious bowel inflammation (pseudomembranous colitis). • If you experience an irregular heart beat, dizziness or faintness during treatment. • If you previously had radiation treatment (radiotherapy) to your chest (see section 4:
Dan jista ’ jkun sinjal ta ’ infjammazzjoni serja fl- imsaren (kolite psewdomembranuża). • Jekk ikollok taħbit tal- qalb irregolari, tistordi jew iħossok ħażin waqt it- trattament.. • Jekk diġà kellek xi kura bir- radjazzjoni (radjuterapija) fuq sidrek (ara sezzjoni 4:
Possible Side Effects). • If you are taking other medicinal products which could interact with paclitaxel (see Using other medicines).
X’ Effetti Oħra). • Jekk qed tieħu mediċini oħrajn li jistgħu jirreaġixxu ma ’ paclitaxel (ara Użu ta ’ mediċini oħrajn).
Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding before you receive treatment with Paxene.
Għid lit- tabib tiegħek jekk inti tqila, jekk taħseb li int tista ’ tkun tqila jew qed tredda ’ qabel ma ’ tirċievi trattament b’ Paxene.
Paxene cannot be used in pregnancy, and women receiving Paxene must not breast-feed.
Paxene ma jistax jintuża fit- tqala u nisa li qed jieħduh m’ għandhomx iredgħu.
Adequate contraceptive precautions should be used when receiving Paxene.
Għandhom jittieħdu prekawzjonijiet xierqa ta ’ kontraċezzjoni meta jkun qed jittieħed Paxene.
Male patients treated with Paxene are advised not to father a child during and up to six months after the treatment.
Pazjenti rġiel trattati b’ Paxene huma rakkomandati sabiex jevitaw rapport li jista ’ jwassal għat- twelid ta ’ tarbija matul u fis- sitt xhur ta ’ wara t- trattament.
Paxene contains alcohol.
Paxene fih l- alkoħol.
Thus it may not be safe for you to drive or to use machinery for up to several hours after you have had your treatment.
Għalhekk tista ’ ma tkunx sikur li ssuq jew tħaddem magni għal diversi sigħat wara li tkun ħadt it- trattament tiegħek.
Check with your doctor.
Iċċekja mat- tabib tiegħek.
You should be able to drive and use machinery between your treatments with Paxene, unless you feel tired or dizzy
Bejn it- trattamenti ta ’ Paxene għandhek mnejn tkun tajba biex issuq u tħaddem magni, kemm- il darba ma tħossokx għajjiena jew storduta.
Important information about some of the ingredients of Paxene:
Tagħrif importanti dwar xi sustanzi f’ Paxene:
This product contains approximately 50% by volume of alcohol.
Dan il- prodott fih madwar 50% bil- volum ta ’ alkoħol.
Each infusion contains up to 21 g of alcohol.
Kull infużjoni fiha sa 21 g ta ’ alkoħol.
Following an infusion of Paxene, your ability to drive or operate machinery may be affected.
Wara infużjoni ta ’ Paxene, il- kapaċità li ssuq jew tħaddem il- magni tista ’ tkun affetwata.
Paxene contains polyoxyl castor oil, which can cause an allergic reaction.
Paxene fih castor oil polyoxyl, li jista ’ jikkaġuna reazzjoni allerġika.
34 Using other medicines:
Użu ta ’ mediċini oħra:
Please tell your doctor before you are given Paxene if you: • are taking ritonavir, nelfinavir, efavirenz, nevirapine (for the treatment of AIDS) or any other prescribed drugs for your condition; • are taking any other medicines prescribed by a physician for any condition (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals, rifampicin, carbamazepine, phenytoin, phenobarbital); • are taking other medicines that you have bought for yourself without a prescription.
Jekk jogħġbok għarraf lit- tabib qabel ma tingħata Paxene jekk inti: • Qed tieħu ritonavir, nelfinavir, efavirenz, nevirapine (għal kura ta ’ AIDS) jew xi mediċini oħra mogħtija bir- riċetta għal kundizzjoni tiegħek; • Qed tieħu xi mediċini oħra mogħtija bir- riċetta mit- tabib tiegħek għal kwalunkwe kundizzjoni (p. e. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals, rifampicin, carbamazepine, phenyton, phenobarbital); • Qed tieħu xi mediċini oħra li int xtrajt għalik mingħajr riċetta.
If you are already being treated with doxorubicin for your condition, then your first dose of paclitaxel should be given 24 hours after doxorubicin.
Jekk diġà qed tiġi kkurata b’ doxorubicin għal kanċer tas- sider u t- tabib tiegħek jixtieq jagħtik paclitaxel ukoll, allura l- ewwel doża tiegħek ta ’ paclitaxel għandha tingħata 24 siegħa wara doxorubicin.
Paxene may alter the effect of other medicines because of its high alcohol content.
35 Paxene jista ’ jibdel l- effett ta ’ mediċini oħra minħabba l- kontenut għoli ta ’ alkoħol li hemm ġo fih.
If you see another doctor or visit a hospital, remember to tell them what medicines you are taking.
Jekk tara xi tabib ieħor jew tmur fi sptar għarrafhom bil- mediċini li qed tieħu.
HOW TO USE PAXENE
KIF JITTIEĦED PAXENE
Your concentrate for solution for infusion will be diluted and given slowly into a vein over about 3 hours unless otherwise stated.
Il- konċentrat tiegħek għal soluzzjoni għall- infużjoni għandu jiġi dilwit u mogħti bil- mod ġo vina fuq perijodu ta ’ madwar 3 sigħat, sakemm ma jiġix dikjarat mod ieħor.
The amounts (dose) of Paxene you will be given will be worked out depending on your body surface area in square meters (m2) and will also take into account the results of your blood tests and your medical condition.
L- ammonti (doża) ta ’ Paxene li inti ser tingħata ser tiġi maħduma skond l- erja superfiċjali tal- ġisem f’ metri kwadri (m2) u ser tieħu inkonsiderazzjoni r- riżultati tat- testijiet tad- demm li għamilt u l- kundizzjoni medika tiegħek.
If necessary, your doctor will adjust the dosage during the treatment.
Jekk ikun meħtieġ, it- tabib tiegħek ser jaġġusta d- doża waqt il- kura.
AIDS-related Kaposi’s sarcoma:
Sarkoma ta ’ Kaposi relatata ma ’ AIDS:
The usual dose of Paxene is 100 mg/m2 of body surface area.
Ġeneralment, id- doża ta ’ Paxene hija ta ’ 100 mg/ m2 ta ’ l- erja suferfiċjali tal- ġisem.
You will be given Paxene every two weeks, as long as the results of your blood tests show that it is safe to carry on with your treatment.
Ser tingħata Paxene kull ġimagħtejn, kemm- il darba r- riżultati tad- demm juru li hu sikur li tkompli tieħu t - trattament tiegħek.
The usual dose of Paxene is 175 mg/m2 of body surface area.
Kanċer tas- sider avvanzat u kanċer ta ’ l- ovarju avvanzat (it- tieni kura preferuta) Ġeneralment, id- doża ta ’ Paxene hija ta ’ 175 mg/ m2 ta ’ l- erja superfiċjali tal- ġisem.
You will be given Paxene every three weeks, as long as the results of your blood tests show that it is safe to carry on with your treatment.
Ser tingħata Paxene kull tlett ġimgħat, kemm- il darba r- riżultati tad- demm juru li hu sikur li tkompli tieħu t - trattament tiegħek.
Advanced ovarian cancer (first-line therapy):
Kanċer ta’ l- ovarju avvanzat (l- ewwel kura preferuta) Jistgħu jingħataw żewġ dożi ta ’ Paxene:
Paxene 175 mg/m2 of body surface area administrated as a 3 hour infusion into a vein, followed by another medicine, cisplatin, every three weeks; alternatively Paxene 135 mg/m2 given as a 24 hour infusion, followed by cisplatin, every three weeks.
Paxene 175 mg/ m2 ta ’ l- erja superfiċjali tal- ġisem mogħti bħala infużjoni ta ’ 3 sigħat ġol- vina, segwit minn mediċina oħra msejħa cisplatin kull tlett ġimgħat; inkella Paxene 135 mg/ m2 mogħti bħala infużjoni fuq 24 siegħa, segwit minn cisplatin, kull tlett ġimgħat.
Your continued treatment will depend on the results of your blood tests showing that it is safe to carry on with your treatment.
Il- kura li ser tkompli tingħata inti tiddependi mir- riżultati tat- testijiet tad- demm kemm- il darba dawn juru li hu sikur li tkun tista ’ tkompli bil- kura tiegħek.
The usual dose of Paxene is 175 mg/m2 of body surface area, followed by cisplatin every three weeks.
Kancer non- small cell lung avvanzat Id- doża ta ’ Paxene li ġeneralment tingħata hi ta ’ 175 mg/ m2 ta ’ l- erja superfiċjali tal- ġisem, segwit minn cisplatin kull tlett ġimgħat.
You will be given this therapy as long as the results of your blood tests show that it is safe to carry on with your treatment.
Inti ser tingħata din it- terapija kemm- il darba r- riżultati tat- testijiet tad- demm juru li hu sikur li tista ’ tkompli bil- kura tiegħek.
To help prevent allergic reactions occurring while you are receiving your infusion you will be given medication before your treatment starts.
Sabiex tgħin tevita li jkollok reazzjonijiet allerġiċi waqt li qed tieħu l- infużjoni ser tingħata mediċini qabel ma jibda t- trattament tiegħek.
Twelve and then six hours before your infusion you will be given dexamethasone (a steroid), either as a tablet to swallow or as an injection.
Tnax- il siegħa u mbagħad sitt sigħat qabel l- infużjoni ser tingħata dexamethasone (sterojdi), jew bħala pillola biex tibla jew bħala injezzjoni.
Half to one hour before your infusion you will be given two different types of injection (an antihistamine and an H2 antagonist).
Minn nofs siegħa sa siegħa qabel l- infużjoni ser tingħata żewġ tipi differenti ta ’ injezzjoni (antihistamine u antagonista H2).
If you have a history of heart
Inti ser tingħata l- infużjoni taħt sorveljanza medika, u ser tiġi ċċekkjat b’ mod regolari waqt li qed tieħu l- infużjoni biex jiġi osservat kif int ser tirreaġixxi għaliha.