qanastek/EMEA-V3 huggingface dataset:
Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenza-like illness, malaise, lethargy, hyperpyrexia
Trombożi
Immune system disorders:
Għeja kbira, telqa, deni
Hypersensitivity
Edema periferali, infjammazzjoni tal- mukoża, uġigħ, tkexkix ta ’ Disturbi ġenerali u bard, edema, dgħjufija, nuqqas ta ’ affiċjenza fix- xogħol i, uġigħ fil- qafas kundizzjonijiet ta ’ mnejn tas- sider, mard jixbah l- influwenza, letarġija, deni qawwi jingħata:
Hepatobiliary disorders Reproductive system and breast disorders:
Disturbi fil- fwied u fil - marrara
Uncommon:
Mhux Komuni1:
Hyperbilirubinaemia, hepatomegaly Uncommon:
Sensittività eċċessiva Mhux Komuni:
Breast pain
Iperbilirubinemja, nefħa tal- fwied
Adverse reactions reported with Abraxane at any dose in clinical trials.
1
Uncommon:
Insomnja, dipressjoni, ansjetà Mhux komuni:
Restlessness 1 The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients
Il- frekwenza ta ’ reazzjonijiet ta ’ sensittività eċċessiva hi kkalkulata fuq il- bażi ta 'każ wieħed definittivament relatat f' popolazzjoni ta' 789 pazjent.
Post-marketing experience
Esperjenza miġbura wara l- bejgħ fis- suq
Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of Abraxane.
Paralisi tan- nervituri kranjali, paresi tal- kordi vokali, u rapporti rari ta ’ reazzjonijiet severi ta ’ sensittività eċċessiva waqt is- sorveljanza ta ’ wara l- bejgħ ta ’ Abraxane.
In some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysaesthesiae have been reported as part of the continuing surveillance of Abraxane.
F’ xi pazjenti li fil- passat kienu esposti għal capecitabine, każi ta ’ palmar- plantar erythrodysaesthesiae kienu rrappurtati bħala parti mis- sorveljanza li qed tkompli ta ’ Abraxane.
Because these events have been reported voluntarily during clinical practice, true estimates of frequency cannot be made and a causal relationship to the events has not been established.
Minħabba li dawn l - avvenimenti kienu rrappurtati b’ mod volontarju matul il- prattika klinika, l- istimi reali tal- frekwenza ma jistgħux isiru, u r- relazzjoni kawżali ma ’ l- avvenimenti ma kinitx stabbilita.
There is no known antidote for paclitaxel overdose.
M’ hemm l- ebda antidot magħruf għal doża eċċessiva ta ’ paclitaxel.
In the event of an overdose, the patient should be closely monitored.
Fil- kaz ta ’ suspett ta’ doża eċċessiva, il- pazjent għandu jkun immonitorjat mill- qrib.
Treatment should be directed at the major anticipated toxicities, which are bone marrow suppression, mucositis and peripheral neuropathy.
Il- kura għandha tkun immirata lejn it - tossiċitajiet antiċipati maġġuri, li huma t- trażżin tal- mudullun, l- mukożite u n- newropatija periferali.
Taxanes, ATC Code:
Taxanes, Kodiċi ATC:
Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Paclitaxel hu sustanza li tibni microtubules minn tubulin dimers u tistabbilizza l- microtubules billi ma tħallix issir id- depolymerisation.
This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Din l- istabbiltà tirriżulta fl- inibizzjoni tar- riorganizzazzjoni dinamika normali tax- xibka tal- microtubules li hi essenzjali għal interphase vitali u l- funzjonijiet ċellulari
In addition, paclitaxel induces abnormal arrays or “ bundles ” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Flimkien ma ’ dan, paclitaxel jorganizza sfilati jew “ qatet ” anormali ta ’ microtubules tul iċ - ċiklu kollu taċ- ċelluli, kif ukoll asters multipli ta ’ microtubules waqt il- mitosi.
Abraxane contains human serum albumin-paclitaxel nanoparticles.
Abraxane fih n- nanopartikuli magħmula minn albumina tas- serum tal- bniedem u paclitaxel.
Albumin is known to mediate endothelial transcytosis of plasma constituents and in vitro studies demonstrated that the presence of albumin enhances transport of paclitaxel across endothelial cells.
Hu magħruf li l- albumina tagħmel medjazzjoni tat- transċitosi endoteljali tal- komponenti tal- plażma, u studji in vitro urew li l- preżenza tal- albumina tiffaċilita t- trasport ta ’ paclitaxel minn naħa għall- oħra taċ- ċelluli endoteljali.
It is hypothesised that this enhanced transendothelial transport is mediated by the gp-60 albumin receptor, and that there is accumulation of paclitaxel in the area of tumour due to the albumin-binding protein SPARC (secreted protein acidic rich in cysteine).
Hu maħsub li dan it- trasport imtejjeb transendoteljali hu medjat mir- riċettur ta ’ l- albumina gp- 60, u li hemm akkumulazzjoni ta ’ paclitaxel fiż- żona tat- tumur minħabba l- proteina SPARC (secreted protein acidic rich in cysteine) li teħel ma ’ l- albumina.
Breast carcinoma:
Karċinoma tas- sider:
Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of Abraxane in metastatic breast cancer.
Informazzjoni fuq 106 pazjent li nġabret minn żewġ studji single- arm open- label u minn 454 pazjent mhux magħżula li kienu kkurati fi studju komparattiv ta ’ Fażi III, hija disponibbli biex issostni l- użu ta ’ Abraxane f’ kanċer metastatiku tas- sider.
This information is presented below.
Din l- informazzjoni hi ppreżentata hawn taħt.
Single-arm open-label studies
Studji single- arm open- label
In one study, Abraxane was administered as a 30-minute infusion at a dose of 175 mg/ m2 to 43 patients with metastatic breast cancer.
Fi studju wieħed, Abraxane ngħata bħala infużjoni fuq perijodu ta ’ 30 minuta f’ doża ta ’ 175 mg/ m2 lil 43 pazjent b’ kanċer metastatiku tas- sider.
The second trial utilised a dose of 300 mg/ m2 as a 30 minute infusion in 63 patients with metastatic breast cancer.
Fit- tieni prova, intużat doża ta ’ 300 mg/ m2 bħala infużjoni fuq perijodu ta ’ 30 minuta fi 63 pazjent b’ kanċer metastatiku tas- sider.
Patients were treated without steroid pre- treatment or planned G-CSF support.
Il- pazjenti li kienu kkurati ma ħadux minn qabel sterojdi jew appoġġ ippjanat G- CSF.
Cycles were administered at 3 week intervals.
Iċ- ċikli ngħataw f’ intervalli ta ’ 3 ġimgħat.
The response rates in all patients were 39.5% (95% CI:
Ir - rati ta ’ rispons fil- pazjenti kollha kienu ta ’ 39. 5% (95% CI:
24.9% - 54.2%) and 47.6%
24. 9% - 54. 2%) u 47. 6% (95% CI:
35.3% - 60.0%), respectively.
35. 3% - 60. 0%), rispettivament.
The median time to disease progression was 5.3 months (175 mg/ m2; 95% CI:
Iż- żmien medjan tar- rispons għall- kura tal- marda kien ta ’ 5. 3 xhur (175 mg/ m2; 95% CI:
4.6 – 6.2 months) and 6.1 months (300 mg/ m2; 95% CI:
4. 6 – 6. 2 xhur) u 6. 1 xhur (300 mg/ m2; 95% CI:
4.2 – 9.8 months).
4. 2 – 9. 8 xhur).
Randomised comparative study:
Studju randomised komparattiv:
This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/ m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as Abraxane 260 mg/ m2 given as a 30 minute infusion without premedication (N = 229).
Din il- prova f’ ħafna ċentri saret f’ pazjenti b’ kanċer metastatiku tas- sider, li kienu kkurati kull 3 ġimgħat b’ paclitaxel waħdu, jew bħala paclitaxel ibbażat fuq is- solvent 175 mg/ m2 mogħti bħala infużjoni ta ’ 3 sigħat bi premedikazzjoni biex tiġi evitata s- sensittività eċċessiva (N = 225), jew bħala Abraxane 260 mg/ m2 mogħti bħala infużjoni ta ’ 30 minuta mingħajr premedikazzjoni (N = 229).
Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases.
Erbgħa u sittin fil- mija tal- pazjenti kellhom indeboliment fl- istat tal- prestazzjoni (ECOG 1 jew 2) fil - bidu ta ’ l- istudju; 79% kellhom metastasi vixxerali; u 76% kellhom > 3 siti ta ’ metastasi.
Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting only, 40% in the metastatic setting only, and 19% in both metastatic and adjuvant settings.
Erbatax fil - mija tal- pazjenti ma kinux irċivew kimoterapija fil- passat; 27% kienu rċivew il- kimoterapija biss bħala kura addizjonali, 40% f’ setting metastatiku biss, u 19% kemm f’ setting metastatiku kif ukoll f’ setting addizjonali.
Fifty-nine percent received study medicinal product as second or greater than second-line therapy.
Disa ’ u ħamsin fil- mija rċivew il- prodott mediċinali li kien qed ikun studjat bħala t- tieni terapija jew iktar mit- tieni terapija.
Seventy-seven percent of the patients had been previously exposed to anthracyclines.
Sebgħa u sebgħin fil- mija tal- pazjenti kienu esposti fil- passat għal anthracyclines.
Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.
Riżultati għar- rata tar- rispons totali u ż- żmien għall- progressjoni tal- marda, u s- sopravivenza mingħajr progressjoni u s- sopravivenza għall- pazjenti li kienu qed jirċievu > terapija ewlenija, huma murija hawn taħt.
Results for overall response rate, median time to disease progression, and progression-free survival as assessed by the investigator
Riżultati għar- rata tar- rispons totali, il- medjan taż- żmien għall- progressjoni tal - marda u s- sopravivenza mingħajr progressjoni, hekk kif evalwata mill- investigatur
Efficacy variable
Effikaċja varjabbli
Solvent-based paclitaxel (175 mg/ m2)
Paclitaxel ibbażat fuq is - solvent (175 mg/ m2)
Response rate [95% CI] (%)
Rata ta ’ rispons [95% CI] (%)
> 1st-line therapy
> Terapija ewlenija
26.5 [18.98, 34.05] (n = 132)
26. 5 [18. 98, 34. 05] (n = 132)
13.2 [7.54, 18.93] (n = 136)
13. 2 [7. 54, 18. 93] (n = 136)
*Median time to disease progression [95% CI] (weeks)
* Żmien medjan għall- progressjoni tal- marda [95% CI] (ġimgħat)
20.9 [15.7, 25.9] (n = 131)
20. 9 [15. 7, 25. 9] (n = 131)
16.1 [15.0, 19.3] (n = 135)
16. 1 [15. 0, 19. 3] (n = 135)
*Median Progression Free Survival [95% CI] (weeks)
* Medjan tal- Progressjoni tas- Sopravivenza Ħielsa [95% CI] (ġimgħat)
20.6 [15.6, 25.9] (n = 131)
20. 6 [15. 6, 25. 9] (n = 131)
16.1 [15.0, 18.3] (n = 135)
16. 1 [15. 0, 18. 3] (n = 135)
*Survival [95% CI] (weeks)
* Sopravivenza [95% CI] (ġimgħat)
56.4 [45.1, 76.9] (n = 131)
56. 4 [45. 1, 76. 9] (n = 131)
46.7 [39.0, 55.3] (n = 136)
46. 7 [39. 0, 55. 3] (n = 136)
* This data is based on Clinical Study Report:
* Din l- informazzjoni hi bbażata fuq ir- Rapport dwar Studju Kliniku:
CA012-0 Addendum dated Final (23 March-2005) a Chi-squared test b Log-rank test
CA012- 0 Addendum bid- data finali (23 ta ’ Marzu, 2005) a Chi- squared test b Log- rank test
9 229 patients treated with Abraxane in the randomized, controlled clinical trial were evaluated for safety.
229 pazjent ikkurati b’ Abraxane fil- prova klinika randomized u kkontrollata li kienu evalwati għas - sigurtà.
Neurotoxictiy to paclitaxel was evaluated through improvement by one grade for patients experiencing grade 3 peripheral neuropathy at any time during therapy.
In- newtrossiċità għal paclitaxel kienet evalwata permezz ta 'titjib bi grad wieħed għall- pazjenti li kellhom newtropatija periferali ta ’ grad 3 fi kwalunkwe ħin matul it- terapija.
The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.
Il- kors naturali tan - newtropatija periferali għar- riżoluzzjoni għal- linja bażi minħabba tossiċità kumulattiva ta 'Abraxane wara > 6 korsijiet ta' kura ma kienx evalwat u għadu mhux magħruf.
The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/ m2 were determined in clinical studies.
Il- farmakokinetika tat- total ta ’ paclitaxel wara infużjonijiet ta ’ 30 u 180 minuta ta ’ Abraxane f’ dożi ta ’ minn 80 sa 375 mg/ m2 kienu stabbiliti fl- istudji kliniċi.
The drug exposure (AUC) increased linearly from 2653 to 16736 ng. hr/ ml following dosing from 80 to 300 mg/ m2.
L- espożizzjoni tal- mediċina (AUC) żdiedet b’ mod lineari minn 2653 sa 16736 ng. siegħa/ ml wara dożaġġ minn 80 sa 300 mg/ m2.
Following intravenous administration of Abraxane to patients with metastatic breast cancer at the recommended clinical dose of 260 mg/ m2, paclitaxel plasma concentrations declined in a multiphasic manner.
Wara l- għoti fil- vini ta ’ Abraxane lil pazjenti b’ kanċer metastatiku tas- sider fid- doża klinika rrakkomandata ta ’ 260 mg/ m2, il- konċentrazzjonijiet ta ’ paclitaxel fil- plażma naqsu b’ mod multifażiku.
The mean Cmax of paclitaxel, which occurred at the end of the infusion, was 18.7 µg/ ml.
Il- medja tas- Cmax ta ’ paclitaxel, li seħħet fit- tmiem ta ’ l- infużjoni, kienet ta ’ 18. 7 µg/ ml.
The mean total clearance was 15 l/ hr/ m2.
Il- medja tat- tneħħija totali kienet ta ’ 15 l/ siegħa/ m2.
The terminal half-life was about 27 hours.
Il- half- life terminali kienet ta ’ madwar 27 siegħa.
The mean volume of distribution was 632 l/ m2; the large volume of distribution indicates extensive extravascular distribution and/ or tissue binding of paclitaxel.
Il- medja tal- volum tad- distribuzzjoni kienet ta ’ 632 l/ m2; il- volum estensiv tad- distribuzzjoni jindika distribuzzjoni extravaskulari estensiva u/ jew rabta ta ’ paclitaxel mat- tessuti.
In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following Abraxane administered intravenously at 260 mg/ m2 over 30 minutes were compared with those following 175 mg/ m2 of the solvent-based paclitaxel injection administered over 3 hours.
10 Fi studju f’ pazjenti b’ tumuri solidi avanzati, il- karatteristiċi farmakokinetiċi ta ’ paclitaxel wara li Abraxane ngħata fil- vina b’ rata ta ’ 260 mg/ m2 fuq perijodu ta ’ 30 minuta, tqabblu ma dawk wara l - għoti ta ’ 175 mg/ m2 ta ’ injezzjoni ta ’ paclitaxel ibbażata fuq is- solvent, mogħtija fuq perijodu ta ’ 3 sigħat.
The clearance of paclitaxel with Abraxane was larger (43%) than that following a solvent-based paclitaxel injection and its volume of distribution was also higher (53%).
It- tneħħija ta ’ paclitaxel li jiġi minn Abraxane kienet ikbar (43%) minn dik b’ injezzjoni ta ’ paclitaxel ibbażata fuq is- solvent, u l- volum tad- distribuzzjoni tiegħu kien ukoll ogħla (53%).
Differences in Cmax and Cmax corrected for dose reflected differences in total dose and rate of infusion.
Id - differenzi fis- Cmax u Cmax ikkoreġut skond id- doża, irriflettew differenzi fid- doża totali u r- rata ta ’ l - infużjoni.
There were no differences in terminal half-lives.
Ma kien hemm l- ebda differenzi fil- half- lives terminali.
The protein binding of paclitaxel following Abraxane administration is estimated at about 90%.
Ir- rabta ta ’ paclitaxel wara l- għoti ta ’ Abraxane hija stmata bejn wieħed u ieħor ta ’ 90%.
Based on the published literature, in vitro studies of binding to human serum proteins, using paclitaxel at concentrations ranging from 0.03 to 1.2 µM, indicate that about 87% of paclitaxel is bound; the presence of ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel.
Ibbażat fuq il- letteratura ppubblikata, studji in vitro tal- għaqda ma ’ proteini fis- serum uman, bl- użu ta ’ paclitaxel f’ konċentrazzjonijiet li jvarjaw minn 0. 03 sa 1. 2 µM, jindikaw li jintrabat madwar 87% ta ’ paclitaxel; il- preżenza tar- ranitidine, id- dexamethasone, jew id- diphenhydramine ma affettwatx l- għaqda tal - paclitaxel mal- proteina.
Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6α -hydroxypaclitaxel; and to two minor metabolites, 3’ -p-hydroxypaclitaxel and 6α -3’ -p-dihydroxypaclitaxel.
Ibbażat fuq il- letteratura ppubblikata, studji in vitro b’ mikrosomi tal- fwied tal- bniedem u biċċiet ta ’ tessut juru li paclitaxel hu mmetabolizzat primarjament għal 6α- hydroxypaclitaxel; u għal żewġ metaboliti żgħar, 3 ’ - p- hydroxypaclitaxel u 6α- 3 ’ - p- dihydroxypaclitaxel.
The formation of these hydroxylated metabolites is catalysed by CYP2C8, -3A4, and both -2C8 and -3A4 respectively.
Il- formazzjoni ta ’ dawn il - metaboliti hydroxylated hi katalizzata minn CYP2C8, - 3A4, u kemm - 2C8 u - 3A4 rispettivament.
The effect of renal or hepatic dysfunction on the disposition of paclitaxel has not been formally investigated.
L- effett tad- disfunzjoni tal- kliewi jew epatka fuq id- dispożizzjoni ta ’ paclitaxel ma kienx investigat formalment.
In patients with metastatic breast cancer, after a 30 minute infusion of Abraxane at 260 mg/ m2, the mean value for cumulative urinary excretion of unchanged active substance accounted for 4% of the total administered dose with less than 1% as the metabolites 6α -hydroxypaclitaxel and 3’ -p-hydroxypaclitaxel, indicating extensive non-renal clearance.
F’ pazjenti b’ kanċer metastatiku tas- sider, wara 30 minuta ta ’ infużjoni ta ’ Abraxane b’ doża ta ’ 260 mg/ m2, il- medja tal- ammont kumulattiv tas- sustanza attiva mhux mibdula li tneħħa fl- awrina kienet ta ’ 4% tad- doża totali mogħtija, b’ inqas minn 1% bħala l- metaboliti 6α- hydroxypaclitaxel u 3 ’ - p- hydroxypaclitaxel, li jindika tneħħija estensiva mhux tal- kliewi.
Paclitaxel is principally eliminated by hepatic metabolism and biliary excretion.
Paclitaxel hu eliminat primarjament permezz tal- metaboliżmu tal- fwied u tneħħija biljari.
Pharmacokinetics of paclitaxel in patients aged over 65 years seems comparable to that in patients less than 65 years.
Il- farmakokinetika ta ’ paclitaxel f’ pazjenti li għandhom iktar minn 65 sena tidher li hi komparabbli ma ’ dik f’ pazjenti li għandhom inqas minn 65 sena.
However, little information in patients over 75 years is available as only 3 patients over 75 years of age where included in the pharmacokinetic analysis.
Madankollu, ftit informazzjoni hi disponibbli f’ pazjenti li kellhom iktar minn 75 sena, għax 3 pazjenti biss fuq il- 75 sena kienu inklużi fl- analiżi farmakokinetika.
The carcinogenic potential of paclitaxel has not been studied.
Il- potenzjal karċinoġeniku ta ’ paclitaxel ma kienx studjat.
However, based on the published literature, paclitaxel is a potentially carcinogenic and genotoxic agent at clinical doses, based upon its pharmacodynamic mechanism of action.
Madankollu, ibbażat fuq il- letteratura ppubblikata, paclitaxel hu sustanza potenzjalment karċinoġenika u ġenotossika f’ dożi kliniċi, ibbażat fuq il- mekkaniżmu farmakodinamiku ta ’ l- azzjoni tiegħu.
Paclitaxel has been shown to be clastogenic in vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice).
Intwera li paclitaxel kien klastoġeniku in vitro (aberrazzjonijiet tal- kromosoma f’ limfoċiti umani) u in vivo (test tal- mikronukleu fil- ġrieden).
10 in the Ames test or the Chinese hamster ovary/ hypoxanthine-guanine phosphoribosyl transferase (CHO/ HGPRT) gene mutation assay.
Intwera li paclitaxel kien ġenotossiku in vivo (test tal- mikronukleu fil- ġrieden), iżda ma kkawżax mutaġeniċità fit- test ta ’ Ames jew fl- assaġġ tal- mutazzjoni tal- ġeni ta ’ l- ovarju tal- ħamster Ċiniż/ hypoxanthine- guanine phosphoribosyl transferase (CHO/ HGPRT).
Paclitaxel at doses below the human therapeutic dose was associated with low fertility and foetal toxicity in rats.
F’ dożi li kienu inqas mid- doża terapewtika fil- bniedem, paclitaxel kien assoċjat ma ’ fertilità baxxa u tossiċità tal- fetu fil- firien.
Animal studies with Abraxane showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Studji fuq l- annimali b’ Abraxane urew effetti tossiċi mhux riversibbli fuq l - organi riproduttivi ta ’ l- irġiel f’ livelli ta ’ espożizzjoni klinikament rilevanti.
Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Soluzzjoni ta ’ l- albumina umana (li fiha sodium, sodium caprylate u N- acetyl DL tryptophanate).
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
11 Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn għajr dawk li kienu msemmija f’ sezzjoni 6. 6.
Unopened vials:
Vjala mhux miftuħa:
Stability of reconstituted suspension in the vial:
L- istabbiltà tas- suspensjoni rrikostitwita fil- vjala:
After first reconstitution, the suspension should be filled into an infusion bag immediately.
Wara l- ewwel rikostituzzjoni, is- suspensjoni għandha timtela f’ borża ta ’ l- infużjoni immedjatament.
However, chemical and physical in use stability has been demonstrated for 8 hours at 2°C - 8°C in the original carton, and protected from bright light.
Madankollu, l- istabbiltà kimika u fiżika waqt l- użu ntweriet għal 8 sigħat f’ temperatura ta ’ 2°C - 8°C fil- kaxxa tal- kartun oriġinali li kienet protetta minn dawl qawwi.
Stability of the reconstituted suspension in the infusion bag:
L- istabbiltà tas- suspensjoni rrikostitwita fil- borża ta ’ l- infużjoni:
After reconstitution, the reconstituted suspension in the infusion bag should be used immediately.
Wara r- rikostituzzjoni, is- suspensjoni rrikostitwita fil- borża ta ’ l- infużjoni għandha tintuża immedjatament.
However chemical and physical in use stability has been demonstrated for 8 hours not above 25°C.
Madankollu, l- istabbiltà kimika u fiżika waqt l- użu ntweriet għal 8 sigħat f’ temperatura ta ’ mhux iktar minn 25°C.
Keep the vial in the outer carton in order to protect from light.
Żomm il- vjala fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall- kundizzjonijiet tal- ħażna tal- prodott mediċinali rrikostitwit, ara sezzjoni 6. 3.
Vial 50ml (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium).
Vjala ta ’ 50ml (ħġieġ ta ’ tip 1) b’ tapp (lastku tal- butyl), b’ siġill fuqu (aluminju).
Pack size one vial of 100 mg paclitaxel.
Daqs tal- pakkett: vjala waħda ta ’ 100 mg ta ’ paclitaxel.
Preparation and administration precautions:
Prekawzjonijiet dwar il- preparazzjoni u l- għoti:
Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane.
Paclitaxel hu prodott mediċinali ċitotossiku kontra l- kanċer, u, bħalma jiġri b’ mediċinali komposti oħrajn li huma potenzjalment tossiċi, għandha tingħata attenzjoni fl- immaniġġjar ta ’ Abraxane.
The use of gloves, goggles and protective clothing is recommended.
L- użu ta ’ ingwanti, goggles (bħala protezzjoni għall- għajnejn) u lbies protettiv hu rrakkomandat.
If the suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Jekk is - suspensjoni tmiss mal- ġilda, il- ġilda għandha tinħasel immedjatament u bir- reqqa bis- sapun u bl- ilma.
If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Jekk il- mediċina tmiss mal- membrani mukużi, il- membrani għandhom jitlaħalħu tajjeb bl- ilma.
Abraxane should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Abraxane għandu jkun ippreparat u mogħti biss minn staff li jkun imħarreġ kif suppost fl- immaniġġjar ta ’ sustanzi ċitotossiċi.
Pregnant staff should not handle Abraxane.
Membri ta ’ l- istaff li jkunu ħarġu tqal m’ għandhomx jippreparaw/ jagħtu Abraxane.
11 Reconstitution and administration of the product:
Ir- rikostituzzjoni u l- għoti tal- prodott:
Abraxane is supplied as a sterile lyophilised powder for reconstitution before use.
Abraxane jiġi fis- suq bħala trab lajofilizzat li għandu jkun ippreparat qabel l- użu.
After reconstitution, each ml of suspension contains 5 mg of paclitaxel.
Wara r - rikostituzzjoni, kull ml ta ’ suspensjoni jkun fih 5 mg ta ’ paclitaxel.
Using a sterile syringe, 20 ml of sodium chloride 9 mg/ ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Bl- użu ta ’ siringa sterili, 20 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- infużjoni għandhom ikunu injettati bil- mod fil- vjala ta ’ Abraxane fuq perijodu minimu ta ’ minuta.
The solution should be directed onto the inside wall of the vial.
Is- soluzzjoni għandha tkun immirita fuq in- naħa ta ’ ġewwa tal- ġenb tal- vjala.
The solution should not be injected directly onto the powder as this will result in foaming.
Is- soluzzjoni m’ għandhiex tkun injettata dritt fuq it- trab għax dan jifforma r- ragħwa.
Once the addition is complete, the vial should be allowed to stand for a minimum of 5 minutes to ensure proper wetting of the solid.
Ġaladarba dan isir, il- vjala għandha titħalla toqgħod għal mill- inqas 5 minuti biex jiġi żgurat li l - materjal solidu jixxarrab kif suppost.
Then, the vial should gently and slowly be swirled and/ or inverted for at least 2 minutes until complete resuspension of any powder occurs.
Il- formazzjoni tar- ragħwa għandha
The generation of foam must be avoided.
12 tkun evitata.
If foaming or clumping occurs, the solution must stand for at least 15 minutes until foam subsides.
Jekk tifforma r- ragħwa jew jiffurmaw ċapep, is- soluzzjoni trid toqgħod għal mill- inqas 15- il minuta sakemm ma jkunx hemm aktar ragħwa.
The reconstituted suspension should be milky and homogenous without visible precipitates.
Is- suspensjoni rrikostitwita għandha tkun qisha ħalib u omoġenja, mingħajr ma jkun hemm materjal solidu viżibbli.
If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.
Jekk materjal solidu jew materjal li jkun qagħad fil- qiegħ ikun viżibbli, il- vjala għandha tinqaleb bil- mod mill- ġdid ta ’ taħt fuq, sabiex tiġi żgurata s- suspensjoni kompleta mill- ġdid qabel l- użu.
Some settling of the reconstituted suspension may occur.
Jista ’ jkun hemm xi materjal li jkun niżel fil- qiegħ tas- suspensjoni rrikostitwita.
Complete resuspension should be ensured by mild agitation before use.
Is - suspensjoni kompleta trid tkun aċċertata billi tħawwad il- vjala bil- mod mill- ġdid qabel l- użu.
Discard the reconstituted suspension if precipitates are observed.
Armi s- suspensjoni rrikostitwita jekk jidher materjal solidu.
Calculate the exact total dosing volume of 5 mg/ ml suspension required for the patient and inject the appropriate amount of reconstituted Abraxane into an empty, sterile, PVC or non-PVC type intravenous bag.
Ikkalkula l- volum totali meħtieġ eżatt tad- dożaġġ ta ’ suspensjoni ta ’ 5 mg/ ml għall- pazjent u injetta l - ammont ta ’ Abraxane rrikostitwit li suppost f’ borża għall- għoti fil- vina, vojta u sterili, tal- PVC jew mhux tal- PVC.
The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
L- użu ta ’ kontenituri speċjalizzati għas- soluzzjoni, ħielsa minn DEHP, jew settijiet ta ’ l- għoti, mhumiex meħtieġa biex tipprepara jew tagħti infużjonijiet ta ’ Abraxane.
In-line filters should not be used.
Filtri in- line m’ għandhomx jintużaw.
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
Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ United Kingdom
Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ Ir- Renju Unit
13
13 ANNESS II
and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX United Kingdom
Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX Ir- Renju Unit
Summary of Product Characteristics, section 4.2).
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (Ara Anness I: Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema Farmakoviġilanza L- MAH irid jiżgura li s- sistema ta ’ farmakoviġilanza hekk kif inhi deskritta f’ verżjoni 2. 0 ippreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, hi implimentata u qed taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) and presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġjar tar- Riskju L- MAH jimpenja ruħu li jagħmel l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil - Pjan ta ’ Farmakoviġilanza, hekk kif kien miftiehem f’ verżjoni 4 tal- Pjan ta ’ l- Immaniġġjar tal- Riskju (RMP) u ppreżentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni tat- Tqegħid fis- Suq u kwalunkwe aġġornamenti sussegwenti tal- RMP kif miftiehem mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP tas- Sistemi ta ’ l- Immaniġġjar tar- Riskju għall- prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin tar- Rapport dwar l- Aġġornament tas- Sigurtà Perjodika (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn dan, RMP aġġornat għandu jkun sottomess • Meta jasal tagħrif ġdid li jista ’ ikollu impatt fuq l- Ispeċifikazzjoni kurrenti tas- Sigurtà, il- Pjan tal- Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • Fi żmien 60 ġurnata minn meta tintlaħaq milestone importanti (farmakoviġilanza jew tnaqqis tar- riskju) • Fuq talba ta ’ l- EMEA
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING Carton and Vial
TIKKETTA
Abraxane 5 mg/ml powder for suspension for infusion
Abraxane 5 mg/ ml trab għal suspensjoni għall- infużjoni
Each vial contains 100 mg paclitaxel.
Kull vjala fiha 100 mg ta ’ paclitaxel
Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate)
Soluzzjoni ta ’ l- albumina umana (li fiha sodium, sodium caprylate u l- N- acetyl DL tryptophanate)
Contains sodium, see package leaflet for further information.
Fiha sodium, ara l- fuljett fil- pakkett għal aktar tagħrif.
Powder for suspension for infusion One vial of 100 mg paclitaxel
Trab għal suspensjoni għall- infużjoni Kull vjala fiha 100 mg ta ’ paclitaxel
Single use vial Intravenous use
Vjala li tintuża darba biss Użu għal fil- vini
Only to be prepared and administered by personnel appropriately trained in handling cytotoxics.
Irid ikun ippreparat u mogħti biss minn staff li jkun imħarreġ kif suppost fl- immaniġġjar ta ’ sustanzi ċitotossiċi.
Abraxane may have substantially different pharmacological properties compared to other paclitaxel formulations.
Abraxane jista ’ ikollu proprjetajiet farmkoloġiċi sostanzjalment differenti meta mqabbla ma ’ formulazzjonijiet oħra ta ’ paclitaxel.
Unopened Vials:
Fjali Mhux Miftuħa:
After first reconstitution:
Wara l- ewwel rikostituzzjoni:
8 hours in a refrigerator in the vial when kept in the outer carton in order to protect from light.
8 sigħat fil- friġġ meta jinżamm fi vjala fil- kartuna ta ’ barra biex tipproteġih mid- dawl.
In an infusion bag: up to 8 hours not above 25oC
F’ borża ta ’ l- infużjoni: sa 8 sigħat f’ temperatura ta ’ mhux iktar minn 25oC.
Abraxane 5 mg/ml powder for suspension for infusion Paclitaxel
Abraxane 5 mg/ ml trab għal suspensjoni għall- infużjoni Paclitaxel
What Abraxane is and what it is used for 2.
X’ inhu Abraxane u għalxiex jintuża 2.
Before you use Abraxane 3.
Qabel ma tuża Abraxane 3.
How to use Abraxane 4.
Kif għandek tuża Abraxane 4.
How to store Abraxane 6.
Kif għandek taħżen Abraxane 6.
WHAT ABRAXANE IS AND WHAT IT IS USED FOR
X’ INHU ABRAXANE U GĦALXIEX JINTUŻA
Paclitaxel belongs to a group of medicines called taxanes used to treat cancers.
Abraxane hu mediċina li fih paclitaxel fl- albumina umana (porzjon ta ’ demm). paclitaxel jappartieni għal grupp ta ’ mediċini msejħa taxanes li jintużaw għall- kura tal- kanċer.
Abraxane is used for the treatment of breast cancer when other therapies have been tried but have not worked and if you are unsuitable for anthracycline containing treatments.
Abraxane jintuża għall- kura ta ’ kanċer tas- sider meta terapiji oħra kienu ġew ippruvati imma ma ħadmux u jekk int ma tkunx tajba għalik kura li jkun fiha anthracycline.
BEFORE YOU USE ABRAXANE
QABEL MA TUŻA ABRAXANE
Do not use Abraxane • if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane • if you are breast feeding • if you have a low white blood cell count (baseline neutrophil counts < 1.5 x 109/l - your doctor will advise you on this)
Tużax Abraxane • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal paclitaxel jew sustanzi oħra ta ’ Abraxane. • jekk qed tredda ’ • jekk għandek għadd baxx taċ- ċelluli tad- demm bojod (għadd tan- newtrofili fil- linja bażi ta ’ < 1. 5 x 109/ l - it- tabib tiegħek ser jagħtik parir dwar dan)
Take special care with Abraxane • if you have poor kidney function • if you experience numbness, tingling, pricking sensations, sensitivity to touch, or muscle weakness • if you have severe liver problems • if you have heart problems
Oqgħod attent ħafna b’ Abraxane • jekk għandek funzjoni tal- kliewi batuta • jekk ikollok sensazzjonijiet ta ’ tmewwit, tnemnim jew tniggiż, sensittività fis- sens tal- mess, jew dgħjufija fil- muskoli • jekk għandek problemi severi tal- fwied • jekk għandek problemi tal- qalb
If you experience any of these conditions your doctor may wish to stop treatment or reduce the dose.
Jekk ikollok xi waħda minn dawn il- kundizzjonijiet, it- tabib tiegħek jista ’ jkun jixtieq iwaqqaf il- kura jew inaqqas id- doża.
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, because they could interact with Abraxane.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, għax dawn jistgħu ma jaqblux ma ’ Abraxane.
Using Abraxane with food and drink Abraxane is unaffected by food and drink.
Meta tieħu Abraxane ma ’ l- ikel u x- xorb Abraxane mhuwiex affettwat mill- ikel u x- xorb.
Pregnancy and breast-feeding Paclitaxel may cause serious birth defects and should therefore not be used if you are pregnant.
Tqala u treddigħ Paclitaxel jista ’ jikkawża difetti serji tat- twelid u għalhekk m’ għandux jintuża jekk inti tqila.
20 Women of childbearing age should use effective contraception during and up to 1 month after receiving treatment with Abraxane.
21 Nisa li jista ’ jkollhom it- tfal, għandhom jużaw kontraċezzjoni effettiva matul u sa xahar wara li jirċievu l- kura b’ Abraxane.
Male patients are advised to not father a child during and up to six months after treatment and should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Pazjenti rgiel huma avżati biex ma jnisslux tfal waqt u sa 6 xhur wara l - kura, u biex jieħdu parir dwar il- konservazzjoni ta ’ l- isperma qabel il- kura minħabba l- possibbiltà ta ’ infertilità irriversibbli minħabba t- terapija b’ Abraxane.
It is not known if paclitaxel passes into breast milk.
Mhux magħruf jekk paclitaxel jitneħħiex fil- ħalib tas- sider.
Because of the possibility of harm to the infant, breast-feeding must be discontinued for the duration of treatment.
Minħabba l- possibbiltà ta ’ ħsara lit- tarbija, it- treddigħ għandu jitwaqqaf sakemm iddum il- kura.
Ask your doctor for advice before taking this medicine.
Itlob il- parir tat- tabib tiegħek qabel tieħu xi mediċina.
Driving and using machines Abraxane may cause side effects such as tiredness (very common) and dizziness (common) that may affect your ability to drive and use machinery.
Sewqan u l- użu tal- magni Abraxane jista ’ jikkawża effetti sekondarji bħal għeja (komuni ħafna) u sturdament (komuni) li jistgħu jaffettwaw il- ħila tiegħek li ssuq u tużu l- makkinarju.
If you experience these symptoms, do not drive or operate machinery until they have fully resolved.
Jekk ikollok dawn is- sintomi, m’ għandekx issuq jew tħaddem xi makkinarju sakemm ikun għaddew għal kollox.
If you are given other medicines as part of your treatment, you should ask your doctor for advice on driving and using machines.
Jekk tingħata mediċini oħrajn bħala parti mill- kura tiegħek, għandek issaqsi lit- tabib tiegħek għal parir dwar is- sewqan u l- użu tal- magni.
Important information about some of the ingredients of Abraxane This medicinal product contains approximately 425 mg sodium per dose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Abraxane Dan il- prodott mediċinali fih madwar 425 mg ta ’ sodium f’ kull doża.
This should be taken into consideration by patients on a controlled sodium diet.
Dan għandu jkun ikkunsidrat minn pazjenti li qegħdin fuq dieta kkontrollata ta ’ sodium.
HOW TO USE ABRAXANE
KIF TUŻA ABRAXANE
Abraxane will be given to you by a doctor or nurse into a vein from an intravenous drip.
Abraxane ser jingħatalek minn tabib jew infermiera fil- vina forsi ta ’ dripp.
The dose you receive is based on your body surface area and blood test results.
Id- doża li tirċievi hi bbażata fuq l- erja tas- superfiċje tal- ġisem u fuq ir- riżultati tat- testijiet tad- demm.
The usual dose is 260 mg/m2 of body surface area.
Id- doża normali hi ta ’ 260 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem.
How often will you receive Abraxane?
Kemm ta ’ spiss ser tingħata Abraxane?
Abraxane is usually given every three weeks.
Abraxane normalment jingħata kull tliet ġimgħat.
How long will it take to give you your intravenous drip?
Kemm iddum biex jingħatalek id- dripp fil- vina?
Abraxane is given over a 30 minute period.
Abraxane jingħata fuq perijodu a 30 minuta.
If you have any further questions on the use of this product ask your doctor.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, jekk jogħġbok staqsi lit- tabib tiegħek.
Like all medicines, Abraxane can cause side-effects, although not everyone gets them.
Bħal kull mediċina oħra, Abraxane jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The very common side-effects (reported in at least 1 out of 10 patients) are: • Loss of hair • Abnormal decrease in the number of neutrophils in the blood • Decrease in the number of white blood cells in the blood • Deficiency of red blood cells • Reduction in the number of lymphocytes in the blood • Effect of peripheral nerves (pain, and numbness) • Pain in a joint or joints • Pain in the muscles • Nausea, diarrhoea • Vomiting • Weakness and tiredness
L- effetti sekondarji komuni ħafna (irrappurtati f’ mill- inqas 1 minn kull 10 pazjenti) huma: • Telf ta ’ xagħar • Tnaqqis anormali fin- numru ta ’ newtrofili fid- demm • Tnaqqis fin- numru ta ’ ċelluli bojod tad- demm • Defiċjenza ta ’ ċelluli ħomor tad- demm • Tnaqqis fin- numru ta ’ limfoċiti fid- demm • Effett fuq nervituri periferali (uġigħ, u tmewwit) • Uġigħ f’ xi ġog jew ġogi • Uġigħ fil- muskoli • Dardir, dijarea • Rimettar • Dgħjufija u għeja
If any of the side-effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
L- effetti komuni oħrajn (irrappurtati f’ mill- inqas 1 minn kull 100 pazjent) huma: • Raxx tal- ġilda, ħakk, ġilda xotta, disturbi fid- dwiefer • Infezzjoni, deni, fwawar
22 5.
22
HOW TO STORE ABRAXANE
KIF TAĦŻEN ABRAXANE
Do not use Abraxane after the expiry date which is stated on the carton and the vial after EXP.
Tużax Abraxane wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun u fuq il- vjala wara JIS.
If not used immediately, the suspension may be stored in a refrigerator (2°C – 8°C) for up to 8 hours in the vial when kept in the outer carton in order to protect it from light.
Wara l- ewwel rikostituzzjoni, is- suspensjoni għandha tintuża minnufih, Jekk ma tintużax minnufih is - suspensjoni tista ’ tinħażen fi friġġ (2°C – 8°C) sa 8 sigħat fil- vjala meta tinżamm fil- kartuna ta ’ barra biex tipproteġiha mid- dawl
The reconstituted suspension in the intravenous drip may be stored for up to 8 hours at a temperature not above 25ºC.
Is- suspensjoni rrikonstitwita fid- dripp fil- vina tista ’ tinħażen sa 8 sigħat f’ temperatura ta ’ mhux iktar minn 25ºC.
What Abraxane contains
X’ fih Abraxane
• The active substance is paclitaxel.
• Is- sustanza attiva hi paclitaxel.
Each vial contains 100 mg of paclitaxel. • After reconstitution, each ml of suspension contains 5 mg of paclitaxel. • The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Kull vjala fiha 100 mg ta ’ paclitaxel. • Wara r- rikostituzzjoni, kull ml ta ’ suspensjoni jkun fih 5 mg ta ’ paclitaxel. • Is- sustanza l- oħra hi l- albumina umana (li fiha sodium, sodium caprylate u l- N- acetyl DL tryptophanate).
What Abraxane looks like and contents of the pack
Id- dehra ta ’ Abraxane u l- kontenuti tal- pakkett
Abraxane is a white to yellow powder for suspension for infusion available in glass vials containing 100 mg paclitaxel.
Abraxane hu trab bejn abjad u isfar għal suspensjoni għall- infużjoni li hu disponibbli fi vjala tal- ħġieġ li fihom 100 mg ta ’ paclitaxel kull waħda.
Marketing Authorisation Holder Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ United Kingdom
Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ Ir- Renju Unit
Manufacturer Catalent UK Packaging Ltd Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX United Kingdom
Catalent UK Packaging Ltd Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX Ir- Renju Unit
Preparation and administration precautions
Struzzjonijiet għall- użu, immaniġġjar u rimi
23 Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane.
24 Prekawzjonijiet dwar il- preparazzjoni u l- għoti Paclitaxel hu prodott mediċinali ċitotossiku kontra l- kanċer, u, bħal ma jiġri b’ komposti oħrajn li huma potenzjalment tossiċi, għandha tingħata attenzjoni fl- immaniġġjar ta ’ Abraxane.
Gloves, goggles and protective clothing should be used.
Ingwanti, goggles u lbies protettiv għandhom jintużaw.
If Abraxane suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Jekk is- suspensjoni ta ’ Abraxane tmiss mal- ġilda, il- ġilda għandha tinħasel immedjatament u bir- reqqa bis- sapun u bl- ilma.
If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water.
Jekk Abraxane imiss il- membrani mukużi, il - membrani għandhom jitlaħalħu tajjeb bl- ilma.
Pregnant staff should not handle Abraxane.
Membri ta ’ l- istaff li jkunu ħarġu tqal m’ għandhomx jimmaniġġjaw Abraxane.
Reconstitution of the product and administration
Ir- rikostituzzjoni tal- prodott u l- għoti
Abraxane should be admin istered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Abraxane għandu jingħata taħt is- superviżjoni ta ’ onkoloġista li jkun ikkwalifikat, f’ unitajiet speċjalizzati fl- għoti ta ’ sustanzi ċitotossiċi.
Abraxane is supplied as a sterile lyophilised powder for reconstitution before use.
Abraxane hu fornut bħala trab lajofilizzat għar- rikostituzzjoni qabel l- użu.
Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should be injected into a vial of Abraxane over a minimum of 1 minute.
Bl- użu ta ’ siringa sterili, 20 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- infużjoni għandha tkun injettata bil- mod ġo vjala ta ’ Abraxane fuq perijodu minimu ta ’ minuta.
The solution should not be injected directly onto the powder as this will result in foaming.
Is- soluzzjoni m’ għandhiex tkun injettata fuq it - trab għax dan ser jirriżulta li tifforma r- ragħwa.
Once the addition is complete, the vial should be allowed to stand for a minimum of 5 minutes to ensure proper wetting of the solid.
Ġaladarba dan isir, il- vjala għandu jitħalla joqgħod għal mill- inqas 5 minuti biex jiġi żgurat li s- solidu jixxarrab kif suppost.
The n, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete resuspension of any powder occurs.
Imbagħad, il- vjala għandu jiddawwar bil- mod u/ jew jinqaleb bil- mod għal mill - inqas 2 minuti sakemm isseħħ is- suspensjoni kompleta mill- ġdid tat- trab kollu.
The generation of foam should be avoided.
Il- formazzjoni tar - ragħwa għandha tkun evitata.
If foaming or clumping occurs, the suspension should stand for at least 15 minutes until foam subsides.
Jekk tifforma r- ragħwa jew jiffurmaw ċapap, is- suspensjoni għandha toqgħod għal mill- inqas 15- il minuta sakemm ir- ragħwa tisparixxi.
The reconstituted suspension should be milky and homogenous without visible precipitates.
Is- suspensjoni rikostitwita għandha tkun qisha ħalib u omoġenja, mingħajr ma jkun hemm materjal solidu viżibbli.
If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.
Jekk materjal solidu jew materjal li jkun issetilja fil- qiegħ ikun viżibbli, il- vjala għandu jinqaleb bil- mod ta ’ taħt fuq mill- ġdid, sabiex tiġi żgurata s- suspensjoni mill- ġdid kompleta qabel l - użu.
Some settling of the reconstituted suspension may occur.
Jista ’ jkun hemm xi materjal li jkun issetilja fil- qiegħ tas- suspensjoni rikostitwita.
Complete resuspension should be ensured by mild agitation of the vial before use.
Is- suspensjoni mill- ġdid kompleta għandha tkun aċċertata billi tħawwad bil- mod il- vjala qabel l- użu.
If precipitates are observed, the reconstituted suspension should be discarded.
Jekk ikun hemm materjal solidu, is- suspensjoni rikostitwita għandha tintrema.
The exact total dosing volume of 5 mg/ml suspension required for the patient should be calculated and the appropriate amount of reconstituted Abraxane should be injected into an empty, sterile, polyvinyl chloride (PVC) type IV bag.
Il- volum totali eżatt tad- dożaġġ ta ’ suspensjoni ta ’ 5 mg/ ml meħtieġa għall- pazjent għandu jkun ikkalkulat u l- ammont li suppost ta ’ Abraxane rikostitwit għandu jkun injettat ġo borża vojta, sterili, tal- polyvinyl chloride (PVC) ta ’ tip IV.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Prodotti mediċinali li jingħataw b’ injezzjoni għandhom ikunu eżaminati viżwalment għal frak u tibdil fil- kulur qabel ma jingħataw, kull meta s- soluzzjoni u l- kontenitur jippermettu.
Stability Unopened vials of Abraxane are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Stabbiltà Vjala mhux miftuħa ta ’ Abraxane hija stabbli sad- data indikata fuq il- pakkett meta l- vjala tibqa ’ fil - kartuna ta ’ barra biex tipproteġiha mid- dawl.
Neither freezing nor refrigeration adversely affects the stability of the product.
La l- iffriżar u lanqas ir- refriġerazzjoni ma għandhom effett ħażin fuq l- istabbiltà tal- prodott.