qanastek/EMEA-V3 huggingface dataset:
Aspartate amino transferase increased
Uġigħ fis- sider Uġigħ Iperbilirubinemija Ipomagnesemija
During TRISENOX treatment, 13 of the 52 patients in the APL studies had one or more symptoms of APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis (see Section 4.4).
Matul it- trattament b’ TRISENOX, 13 minn 52 pazjent fl- istudji APL kellhom wieħed jew aktar mis - sintomi ta 'sindrom ta ’ differentjazzjoni ta ’ APL, ikkaraterizzat b' deni, qtugħ ta' nifs, żjieda fil- piż, infiltrati pulmonari u effużjonijiet plewrali jew perikardjali, bil - jew mingħajr lewkoċitożi (ara Sezzjoni 4. 4).
Twenty-seven patients had leukocytosis (WBC ≥ 10 x 103/μ l) during induction, 4 of whom had values above 100,000/μ l.
Sebgħa u għoxrin pazjent kellhom lewkoċitożi (WBC ≥ 10 x 103/ μl) matul l- induzzjoni, 4 minnhom kellhom valuri ogħla minn 100, 000/ μl.
Baseline white blood cell (WBC) counts did not correlate with development of leukocytosis on study, and WBC counts during consolidation therapy were not as high as during induction.
Il- kownts tal- linjabażi taċ- ċelluli bojod fid- demm (WBC) ma kinux jikkorrelaw ma 'l- iżvilupp ta' lewkoċitożi meta ġew studjati, u l- kownts WBC matul it- terapija ta ’ konsolidazzjoni ma ’ kinux għolja daqs dawk ta ’ meta saru l- induzzjoni.
In these studies, leukocytosis was not treated with chemotherapeutic medicinal products.
F’ dawn l- istudji, il- lewkoċitożi ma kinitx ikkurata permezz ta ’ prodotti mediċinali kemoterapewtiċi.
Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leukocytosis, and no standard approach has proven effective.
Il- prodotti mediċinali li jintużaw biex ibaxxu l- kownt taċ- ċelluli bojod fid- demm spiss jiggravaw it- tossiċitajiet aktar serji li huma assoċjati ma 'lewkoċitożi, u l- ebda metodu standard ma nstab li hu effettiv.
One patient treated under a compassionate use program died from cerebral infarct due to leukocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count.
Pazjent wieħed li kien ikkurat skond programm ta 'l- użu b' kompassjoni miet minn infart ċerebrali minħabba il - lewkoċitożi wara t- trattament bil- prodotti mediċinali kemoterapewtiċi biex ibaxxu l- kownt WBC.
Observation is the recommended approach with intervention only in selected cases.
L - osservazzjoni hi l- metodu rrakkomandat bl- intervent f' każi magħżula biss.
Mortality in the pivotal studies from disseminated intravascular coagulation (DIC) associated haemorrhage was very common (> 10%), which is consistent with the early mortality reported in the literature.
Il- mortalità fi studji pivotali minn ememorraġija assoċjata ma ’ koagulazzjoni intravaskulari mifruxa (DIC) kienet komuni ħafna (> 10%), li hi konsistenti ma ’ mortalità bikrija rrapportata fil- literattura.
Arsenic trioxide can cause QT interval prolongation (see Section 4.4).
Arsenic trioxide jista ’ jikkaġuna prolongazzjoni ta ’ l- intervall QT (ara sezzjoni 4. 4).
QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Il- prolongazzjoni tal- QT tista ’ twassal għal arritmija ventrikulari tat- tip- torsade de pointes li tista ’ tkun fatali.
The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Pazjent (li rċieva prodotti
One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.
6 mediċinali multipliċi, konkomitanti, inklużi amphotericin B) kellha torsade de pointes asimptomatiku matul it- terapija ta ’ l- induzzjoni għall- APL rikadut bl- arsenic trioxide.
She went onto consolidation without further evidence of QT prolongation.
Hi avvanzat għall - konsolidazzjoni mingħajr aktar xhieda ta ’ prolongazzjoni QT.
Peripheral neuropathy, characterised by paresthesia/ dysesthesia, is a common and well known effect of environmental arsenic.
Newtropatija periferali, kkaratterizzata minn parestesija/ disestesija hi komuni u effett magħruf sew ta ’ arseniku ambjentali.
Only 2 patients discontinued treatment early due to this adverse event and one went on to receive additional TRISENOX on a subsequent protocol.
Żewġ pazjenti biss ma komplewx it- trattament fi żmien bikri minħabba l- episodju avvers u wieħed minnhom kompla u ngħata TRISENOX addizzjonali matul il- protokoll sussegwenti.
Forty-four percent of patients experienced symptoms that could be associated with neuropathy; most were mild to moderate and were reversible upon cessation of treatment with TRISENOX.
Erbgħa u erbgħin fil- mija tal- pazjenti esperjenzaw sintomi li setgħu kienu marbuta ma 'newtropatija, il- biċċa l- kbira kienu bejn mhux qawwija u moderati u kienu riversibbli hekk kif waqaf t- trattament b’ TRISENOX.
6 The following adverse events have been identified during the post-approval use of TRISENOX and have been included following consideration of the observed frequency, seriousness and possible causal relationship to TRISENOX.
L- episodji avversi li ġejjin kienu identifikati matul l- użu ta ’ wara l- approvazzjoni ta ’ TRISENOX u kienu nklużi wara l- konsiderazzjoni ta ’ frekwenza osservata, gravità u possibilità ta ’ relazzjoni kawżali ma ’ TRISENOX.
They are listed below by system organ class and frequency (frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100), not known (cannot be estimated from the available data).
Dawn huma mniżżla taħt skond is- sistema tal- klassifika tal- organi u l - frekwenza (frekwenzi huma definiti bħala: mhux komuni (≥1/ 1, 000 sa < 1/ 100), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
System Organ Class Infection and Infestations
Sistema tal- Klassifika tal- Organi Infezzjonijiet u infestazzjonijiet
Uncommon Sepsis Pneumonia Herpes zoster
Mhux komuni Sepsi Pnewmonja Herpes zoster
Blood and Lymphatics System Disorders
Disturbi tad- Demm u tas- Sistema Limfatika
Metabolism and Nutrition Disorders Psychiatric Disorders Nervous System Disorders
Disturbi fil- Metaboliżmu u n - Nutrizzjoni Disturbi Psikjatriċi Disturbi fis- Sistema Nervuża
Dehydration Fluid retention Confusional state Convulsions Dizziness
Deidratazzjoni Żamma tal- fluwidi Stat ta ’ konfużjoni Konvulżjonijiet Sturdament
Eye Disorders Cardiac Disorders
Disturbi fl- għajnejn Disturbi fil- qalb
Vision blurred Cardiac failure Ventricular tachycardia Ventricular extrasystoles
Vista Mċajpra Difett kardijaku Takikardija ventrikulari Ekstrasistoli ventrikulari
Vascular Disorders
Disturbi vaskulari
Respiratory, Thoracic and Mediastinal Disorders
Disturbi Respiratorji, Toraċiċi u Medjastinali:
Pneumonitis
Pnewmonite
Differentiation syndrome
Sindrome ta ’ divrenzjar
Gastrointestinal Disorders
Disturbi Gastro- Intestinali
Vomiting Abdominal pain
Rimettar Uġigħ fl- istonku
Skin and Subcutaneous Disorders
Disturbi fil- Ġilda u fit- Tessuti ta ’ Taħt il- Ġilda Disturbi fil- kliewi u fis- sistema urinarja
Face oedema Rash
Edima fil- wiċċ Raxx Insuffiċjenza renali
Renal and Urinary Disorders General Disorders and Administration Site Conditions Investigations
Disturbi Ġenerali u Kondizzjonijiet ta ’ Mnejn jingħata Investigazzjonijiet
Renal failure Oedema Chills Blood creatinine increased Weight increased
Edima Kesħa Żjieda fil- krejatinina fid- demm Żjieda fil- piż
In post marketing experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with TRISENOX.
Fl- esperjenza ta ’ wara t- tqegħid fis- suq, sindrome ta ’ divrenzjar, bħas- sindrome ta ’ retinoic acid, ukoll kienet irrapportata għall- kura ta ’ tumuri malinni minbarra APL b’ TRISENOX.
If symptoms suggestive of serious acute arsenic toxicity (e. g. convulsions, muscle weakness and confusion) appear, TRISENOX must be immediately discontinued and chelating therapy with penicilamine at a daily dose ≤ 1 gm per day may be considered.
Jekk jidhru s- sintomi li jissuġġerixxu tossiċità serja akuta arsenika (eż. konvulżjonijiet, debbolezza fil - muskoli u konfużjoni), TRISENOX għandu jitwaqqaf minnufih u terapija ta ’ kelazzjoni flimkien ma ’ penicilamine b’ doża ta ’ kuljum ta ’ ≤ 1 gm kuljum għandha mnejn tkun ikkonsidrata.
The duration of treatment with penicillamine must be evaluated taking into account the urinary arsenic laboratory values.
Iż- żmien tat - trattament bil- penicillamine jrid ikun evalwat u wieħed irid iqies il- valuri tal- laboratorju ta 'l- arseniku fl- awrina.
For patients who cannot take oral medication, dimercaprol administered at a dose of 3 mg/ kg intramuscularly every 4 hours until any immediately life-threatening toxicity has subsided may be considered.
7 jagħti dimercaprol f' doża ta ’ 3 mg/ kg ġol- muskolu kull 4 sigħat sakemm tonqos kwalunkwe tossiċità immedjata li tista ’ tikkawża l- mewt.
Thereafter, penicillamine at a daily dose ≤ 1 gm per day may be given.
Imbagħad, għandha mnejn tingħata doża ta ’ kuljum ta ’ ≤ 1 gm kuljum ta ’ penicillamine.
In the presence of coagulopathy, the oral administration of the chelating agent Dimercaptosuccinic Acid Succimer (DCI) 10 mg/ kg or 350 mg/ m2 every 8 hours during 5 days and then every 12 hours during 2 weeks is recommended.
Meta jkun hemm kojagulopatija, l- għoti mill- ħalq ta ’ aġent ta ’ kelazzjoni Dimercaptosuccinic Acid Succimer (DCI) 10 mg/ kg jew 350 mg/ m2 kull 8 sigħat matul 5 ijiem u imbagħad kull 12- il siegħa matul 2 ġimgħat hu rrakkomandat.
For patients with severe, acute arsenic overdose, dialysis should be considered
Fil- każ ta ’ pazjenti li jbatu minn doża eċċessiva severa, akuta ta ’ arseniku, wieħed għandu jara jekk għandux jingħata d- dijaliżi.
Other antineoplastic agents, ATC code:
Aġenti antineoplastiċi oħra, Kodiċi ATC:
7 TRISENOX has been authorised under “ Exceptional Circumstances”.
TRISENOX kien awtorizzat taħt “ Ċirkustanzi ta ’ Eċċezzjoni ”.
This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Dan ifisser li minħabba li l- marda li qed tbati minnha hi rari ma kienx possibbli li tinkiseb l- informazzjoni kompleta dwar dan il- prodott mediċinali.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
L- Aġenzija Ewropea dwar il- mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ dwar dan il- prodott kull sena u ser taġġorna dan is- Sommarju tal- Karatteristiċi tal - Prodott skond il- bżonn.
The mechanism of action of TRISENOX is not completely understood.
Il- mekkaniżmu ta ’ l- azzjoni ta ’ TRISENOX mhux kompletament mifhum.
Arsenic trioxide causes morphological changes and deoxyribonucleic acid (DNA) fragmentation characteristic of apoptosis in NB4 human promyelocytic leukaemia cells in vitro.
Arsenic trioxide jikkawża tibdil morfoloġikali u fragmentazzjoni ta ’ deoxyribonucleic acid (DNA) li huma karatteristika ta ’ apoptożi f’ ċelluli in vitro tal- lewkimja promijeloċitika umana NB4.
Arsenic trioxide also causes damage or degradation of the fusion protein Pro-Myelocytic Leukaemia/ Retinoic Acid Receptor-alpha (PML/ RAR alpha).
L- Arsenic trioxide jikkawża wkoll dannu jew degradazzjoni fil- protein tal- fużjoni Pro- Myelocytic Leukaemia/ Retinoic Acid Receptor- alpha (PML/ RAR alpha).
Clinical trials:
Testijiet kliniċi:
TRISENOX has been investigated in 52 APL patients, previously treated with an anthracycline and a retinoid regimen, in two open-label, single-arm, non-comparative studies.
TRISENOX ġie investigat f’ 52 pazjent APL, li qabel kienu kkurati bil- anthracycline u reġimen ta ’ retinoid, f’ żewġ studji open- label, single- arm, mhux komparattivi.
One was a single investigator clinical study (n=12) and the other was a multicentre, 9-institution study (n=40).
Wieħed minnhom kien kliniku ta ’ investigatur (n=12) u l- ieħor kien multiċentriku, studju ta ’ 9- instituzzjoni (n=40).
Patients in the first study received a median dose of 0.16 mg/ kg/ day of TRISENOX (range 0.06 to 0.20 mg/ kg/ day) and patients in the multicentre study received a fixed dose of 0.15 mg/ kg/ day.
Pazjenti ta 'l- ewwel studju ngħataw doża medjana ta ’ 0. 16 mg/ kg/ kuljum ta ’ TRISENOX (bejn 0. 06 sa 0. 20 mg/ kg/ kuljum) u pazjenti fl- istudji multiċentriku ngħataw doża fissa ta' 0. 15 mg/ kg/ kuljum.
TRISENOX was administered intravenously over 1 to 2 hours until the bone marrow was free of leukaemic cells, up to a maximum of 60 days.
TRISENOX kien mogħti ġol- vina fuq firxa ta 'minn 1 sa 2 sagħtejn sakemm il- mudullun ta' l- għadma kien ħieles miċ- ċelluli lewkemiċi, sa massimu ta '60 ġurnata.
Patients with complete remission received consolidation therapy with TRISENOX for 25 additional doses over a 5 week period.
Pażjenti li kellhom rimessjoni kompleta, ngħataw terapija ta ’ konsolidazzjoni b’ TRISENOX għal 25 doża addizzjonali fuq firxa ta ’ perijodu ta ’ 5 ġimgħat.
Consolidation therapy began 6 weeks (range, 3-8) after induction in the single institution study and 4 weeks (range, 3-6) in the multicentre study.
It- terapija ta ’ konsolidazzjoni bdiet 6 ġimgħat (firxa, 3- 8) wara l- induzzjoni fl- uniku studju instituzzjonali u 4 ġimgħat (firxa, 3- 6) fl- istudju multiċentriku.
Complete remission (CR) was defined as the absence of visible leukaemic cells in the bone marrow and peripheral recovery of platelets and white blood cells.
Remissjoni kompleta (RK) kienet definita bħala n- nuqqas ta ’ ċelluli lewkemiċi viżibbli fil- mudullun ta ’ l- għadma u rkupru periferali tal - plejtlits u lewkoċiti.
Patients in the single centre study had relapsed following 1-6 prior therapy regimens and 2 patients had relapsed following stem cell transplantation.
Pazjenti fl- istudju ċentriku uniku kellhom rikaduta wara 1- 6 ir- reġimeni ta 'terapija ta ’ qabel u 2 pazjenti kellhom rikaduta wara t- trapjant taċ- ċelluli staminali.
Patients in the multicentre study had relapsed following 1-4 prior therapy regimens and 5 patients had relapsed following stem cell transplantation.
Pazjenti fl- istudju multiċentriku kellhom rikaduta wara 1- 4 ir- reġimeni ta 'terapija ta ’ qabel u 5 pazjenti kellhom rikaduta wara t - trapjant taċ- ċelluli staminali.
The median age in the single centre study was 33 years (age range 9 to 75).
L- età medjana fl- istudju ċentriku uniku kienet 33 sena (firxa ta 'l- età minn 9 sa 75).
The median age in the multicentre study was 40 years (age range 5 to 73).
L- età medjana fl- istudju multiċentriku kienet 40 sena (firxa ta 'l- età minn 5 sa 73).
The results are summarised in the table below.
Ir- riżultati huma murija fil- qosor fit- tabella t’ hawn taħt.
Single
Studju Ċentriku Uniku N=12
Centre Trial N=12
Studju
Multicentre Trial N=40
Multiċentriku N=40
TRISENOX Dose, mg/ kg/ day (Median, Range)
Doża ta ’ TRISENOX, mg/ kg/ kuljum (Medjana, Firxa)
0.16 (0.06 – 0.20)
0. 16 (0. 06 – 0. 20)
Complete Remission Time to Bone Marrow Remission (Median)
Remissjoni Kompleta Żmien għar- Remissjoni tal - Mudullun ta ’ l- Għadma
11 (92%) 32 days
11 (92%) 32 ġurnata
34 (85%) 35 days
34 (85%) 35 ġurnata
Time to CR (Median) 18-Month Survival
Sopravivenza ta ’ 18- il Xahar
The single institution study included 2 paediatric patients (< 18 years old), both of whom achieved CR.
L- istudju ta 'istituzzjoni unika inkluda 2 pazjenti pedjatriċi (< 18- il sena), it- tnejn kellhom RK.
The multicentre trial included 5 paediatric patients (< 18 years old), 3 of whom achieved CR.
L - istudju multiċentriku inkluda 5 pazjenti pedjatriċi (< 18- il sena), 3 minnhom kellhom RK.
No children of less than 5 years of age were treated.
L- ebda tifel/ tifla ta ’ taħt il- 5 snin ma kien ikkurat/ a.
In a follow-up treatment after consolidation, 7 patients in the single institution study and 18 patients in the multicentre study received further maintenance therapy with TRISENOX.
Fi trattamenti ta ’ wara il- konsolidazzjoni, 7 pazjenti fl- istudju ta 'istituzzjoni unika u 18- il pazjent fl - istudju multiċentriku ngħataw aktar terapija ta' manteniment b’ TRISENOX.
Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing TRISENOX.
Tlett pazjenti mill- istudju ta ’ istituzzjoni unika u 15- il pazjent mill- istudju multiċentriku ngħataw trapjanti ta ’ ċelluli staminali wara t- tmiem ta ’ TRISENOX.
At last follow-up, 6 of 12 patients in the single institution study were alive with a median follow-up time of 28 months (range 25 to 29).
Il- perijodu ta ’ KR medjan ta ’ Kaplan- Meier għall- istudju ta ’ istituzzjoni unika kien 14- il xahar xhur u li qatt ma ntlaħaq fi studju multiċentriku Fil- istadju ta 'wara, 6 minn 12- il pazjent fl- istudju ta ’ istituzzjoni unika kienu ħajjin b’ medja ta' żmien medju ta ’ wara ta ’ 28- il xahar (firxa minn 25 sa 29).
In the multicentre study 27 of 40 patients were alive with a median follow-up time of 16 months (range 9 to 25).
Fl- istudju multiċentriku 27 minn 40 pazjent kienu ħajjin bi żmien medjan ta ’ 16 - il xahar (firxa ta ’ minn 9 sa 25).
Kaplan-Meier estimates of 18-month survival for each study are shown below.
L- estimi Kaplan- Meier ta ’ sopravivenza ta ’ 18- il xahar għal kull studju jidhru hawn taħt.
Cytogenetic confirmation of conversion to a normal genotype and Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) detection of PML/ RARα conversion to normal are shown in the table below.
Single Centre - Ċentru Uniku; At Risk – F’ Riskju, Deaths – Mwiet; 18- Month – 18- il Xahar Multicentre Study – Studju Multiċentriku; Months - Xhur Konfirmazzjoni ċitoġenetika tal- bidla għal ġenotip normali u l- bidla ta ’ Reverse Transcriptase - Polymerase Chain Reaction (RT- PCR) detection of PML/ RARα għan- normal huma murija fit- tabella hawn taħt.
Cytogenetics after TRISENOX therapy
Ċitoġenetiċi wara terapija b’ TRISENOX
Conventional Cytogenetics [t(15; 17)]
Ċitoġenetiċi Konvenzjonali [t( 15; 17)]
Single Centre Pilot Trial N with CR = 11
Ċentru Uniku N ma ’ =11
Multicentre Trial N with CR = 34
Multiċentriku N ma ’ KR = 34
Absent Present Not evaluable
Preżenti
RT-PCR for PML/ RAR α
Ma jistgħux ikunu stmati RT- PCR għal PML /
Negative Positive Not evaluable
Negattivi
Responses were seen across all age groups tested, ranging from 6 to 75 years.
Ir- risponsi kienu osservati fuq il- medda tal- gruppi kollha ta ’ l- età li ġew ittestjati u li jvarjaw minn 6 sa 75 sena.
The response rate was similar for both genders.
Ir- rata ta ’ rispons kienet l- istess għaż- żewġ sessi.
There is no experience on the effect of TRISENOX on the variant APL containing the t(11; 17) and t(5; 17) chromosomal translocations.
M’ hemmx esperjenza fuq l- effett ta ’ TRISENOX fuq il- varjant APL li fih it- t( 11; 17) u t( 5; 17) translokazzjoni kromożomali.
The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (AsIII).
Il- forma inorganika u lajofiliżżata ta ’ arsenic trioxide, meta mqegħda ġewwa soluzzjoni, tifforma immedjatament il- prodott ta ’ idrolisi arsenious acid (AsIII).
AsIII is the pharmacologically active species of arsenic trioxide.
AsIII huwa l- ispeċi attiva farmakoloġikament ta ’ arsenic trioxide.
9 In the total single dose range of 7 to 32 mg (administered as 0.15 mg/ kg), systemic exposure (AUC) appears to be linear.
Fil- firxa totali ta ’ doża waħda ta ’ 7 sa 32 mg (mogħti bħala 0. 15 mg/ kg), l- esponiment sistemiku (AUC) jidher li huwa lineari.
The decline from peak plasma concentration of AsIII occurs in a biphasic manner and is characterized by an initial rapid distribution phase followed by a slower terminal elimination phase.
It- tnaqqis mill- konċentrazzjoni massima fil- plażma ta ’ AsIII iseħħ f’ mod bifażiku u huwa kkaratterizzat minn fażi ta ’ distribuzzjoni rapida fil- bidu segwita minn fażi ta ’ eliminazzjoni terminali aktar bil- mod.
After administration at 0.15 mg/ kg on a daily (n=6) or twice-weekly (n=3) regimen, an approximate 2-fold accumulation of AsIII was observed as compared to a single infusion.
Wara l- għoti ta ’ 0. 15 mg/ kg fuq kors ta ’ kuljum (n=6) jew ta ’ darbtejn fil- ġimgħa (n=3), kienet osservata akkumulazzjoni ta ’ madwar id- doppju ta ’ AsIII meta mqabbel ma infużjoni waħda.
This accumulation was slightly more than expected based on single-dose results.
Din l- akkumulazzjoni kienet kemmxejn aktar minn dak mistenni bbażat fuq riżultati ta ’ doża waħda.
The volume of distribution (Vd) for AsIII is large (> 400 L) indicating significant distribution into the tissues with negligible protein binding.
Il- volum ta ’ distribuzzjoni (Vd) għal AsIII huwa kbir (> 400 L) u dan jindika distribuzzjoni sinifikanti ġewwa t- tessuti bi twaħħil negliġibbli mal- proteini.
Vd is also weight dependent, increasing with increasing body weight.
Vd huwa dipendenti fuq il- piż wkoll, jiżdied b’ żjieda fil- piż tal- ġisem.
Total arsenic accumulates mainly in the liver, kidney, and heart and, to a lesser extent, in the lung, hair, and nails.
Arsenic totali jakkumula primarjament fil- fwied, kliewi, u qalb u, fi kwantità inqas, fil- pulmun, xagħar, u dwiefer.
The metabolism of arsenic trioxide involves oxidation of arsenious acid (AsIII), the active species of arsenic trioxide, to arsenic acid (AsV), as well as oxidative methylation to monomethylarsonic acid (MMAV) and dimethylarsinic acid (DMAV) by methyltransferases, primarily in the liver.
Il- metaboliżmu ta ’ arsenic trioxide jinvolvi ossidazzjoni ta ’ arsenious acid (AsIII), l- ispeċi attiva ta ’ arsenic trioxide, għal arsenic acid (AsV), kif ukoll il- metilazzjoni ossidattiva għal monomethylarsonic acid (MMAV) u dimethylarsinic acid (DMAV) permezz ta ’ methyltransferases, primarjament fil- fwied.
The pentavalent metabolites, MMAV and DMAV, are slow to appear in plasma (approximately 10-24 hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII.
Il- metaboliti pentavalenti, MMAV u DMAV, huma osservati bil- mod fil- plażma (madwar 10- 24 siegħa wara l- ewwel għoti ta ’ arsenic trioxide), iżda minħabba l- half- life itwal tagħhom, jakkumulaw aktar wara dożaġġ multiplu minn AsIII.
The extent of accumulation of these metabolites is dependent on the dosing regimen.
Il- grad ta ’ akkumulazzjoni ta ’ dawn il- metaboliti huwa dipendenti fuq il- kors ta ’ dożaġġ.
Approximate accumulation ranged from 1.4- to 8-fold following multiple as compared to single dose administration.
L- akkumulazzjoni approssimattiva varjat minn 1. 4 sa 8 darbiet wara għoti ta ’ dożi multipli meta mqabbel ma ’ l- għoti ta ’ doża waħda.
AsV is present in plasma only at relatively low levels.
AsV huwa preżenti fil- plażma f’ livelli relattivament baxxi biss.
In vitro enzymatic studies with human liver microsomes revealed that arsenic trioxide has no inhibitory activity on substrates of the major cytochrome P450 enzymes such as 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/ 5, 4A9/ 11.
Studji in vitro bl- enzimi b’ mikrosomi tal- fwied tal- bnedmin urew li arsenic trioxide m’ għandu l- ebda attività inibitorja fuq substrati ta ’ l- enzimi maġġuri taċ- ċitokromju P450 bħal 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/ 5, 4A9/ 11.
Drugs that are substrates for these P450 enzymes are not expected to interact with TRISENOX.
Mediċini li huma substrati ta ’ dawn l- enzimi ta ’ P450 mhux mistennija li jinteraġixxu ma ’ TRISENOX.
Approximately 15% of the administered TRISENOX dose is excreted in the urine as unchanged AsIII.
Madwar 15% tad- doża mogħtija ta ’ TRISENOX hija mneħħija fl- awrina bħala AsIII mhux mibdul.
The methylated metabolites of AsIII (MMAV, DMAV) are primarily excreted in the urine.
Il - metaboliti metilati ta ’ AsIII (MMAV, DMAV) huma mneħħija primarjament fl- awrina.
The plasma concentration of AsIII declines from peak plasma concentration in a biphasic manner with a mean terminal elimination half-life of 10 to 14 hours.
Il - konċentrazzjoni fil- plażma ta ’ AsIII tonqos mill- konċentrazzjoni massima fil- plażma b’ mod bifażiku b’ half- life medja ta ’ l- eliminazzjoni terminali ta ’ 10 sigħat sa 14- il siegħa.
The total clearance of AsIII over the single-dose range of 7-32 mg (administered as 0.15 mg/ kg) is 49 L/ h and the renal clearance is 9 L/ h.
It- tneħħija totali ta ’ AsIII fuq il- firxa ta ’ doża waħda ta ’ 7- 32 mg (mogħti bħala 0. 15 mg/ kg) hija 49 L/ h u t- tneħħija renali hija 9 L/ h.
Clearance is not dependent on the weight of the subject or the dose administered over the dose range studied.
Fuq il- firxa ta ’ dożi studjati t- tneħħija mhux dipendenti fuq il- piż ta ’ l- individwu jew fuq id- doża mogħtija.
The mean estimated terminal elimination half-lives of the metabolites MMAV and DMAV are 32 hours and 70 hours, respectively.
Il- half- lives medji stmati ta ’ l- eliminazzjoni terminali tal- metaboliti MMAV u DMAV huma 32 siegħa u 70 siegħa, rispettivament.
Renal Impairment:
10 Indeboliment Renali:
Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 mL/ min) or moderate renal impairment (creatinine clearance of 30-49 mL/ min).
It- tneħħija mill- plażma ta ’ AsIII ma kienetx mibdula f’ pazjenti b’ indeboliment renali ħafif (tneħħija tal - krejatinina ta ’ 50- 80 mL/ min) jew b’ indeboliment renali moderat (tneħħija tal- krejatinina ta ’ 30- 49 mL/ min).
The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 mL/ min) was 40% lower when compared with patients with normal renal function (see section 4.4).
It- tneħħija mill- plażma ta ’ AsIII f’ pazjenti b’ indeboliment renali sever (tneħħija tal - krejatinina inqas minn 30 mL/ min) kienet 40% inqas meta mqabbel ma ’ pazjenti b’ funzjoni renali normali (ara sezzjoni 4. 4).
Systemic exposure to MMAV and DMAV tended to be larger in patients with renal impairment; the clinical consequence of this is unknown but no increased toxicity was noted.
Esponiment sistemiku għal MMAV u DMAV kellu tendenza li jkun akbar f’ pazjenti b’ indeboliment renali; il- konsegwenza klinika ta ’ dan mhux magħrufa iżda ma kienet innutata l- ebda żjieda fit - tossiċità.
Hepatic Impairment:
Indeboliment Epatiku:
Pharmacokinetic data from patients with hepatocellular carcinoma having mild to moderate hepatic impairment indicate that AsIII or AsV do not accumulate following twice-weekly infusions.
Tagħrif farmakokinetiku minn pazjenti b’ karċinoma epatoċellulari b’ indeboliment epatiku ħafif sa moderat jindika li AsIII jew AsV ma jakkumulawx wara infużjonijiet ta ’ darbtejn fil- ġimgħa.
No clear trend toward an increase in systemic exposure to AsIII, AsV, MMAV or DMAV was observed with decreasing level of hepatic function as assessed by dose-normalized (per mg dose) AUC.
Ma kienet osservata l- ebda tendenza ċara lejn żjieda fl- esponiment sistemiku għal AsIII, AsV, MMAV jew DMAV bi tnaqqis fil- livell ta ’ funzjoni epatika kif stmat mill- AUC ta ’ doża normalizzata (kull mg ta ’ doża).
Limited reproductive toxicity studies of arsenic trioxide in animals indicate embryotoxicity and teratogenicity (neural tube defects, anophthalmia and microphthalmia) at administration of 1-10 times the recommended clinical dose (mg/ m2).
Studji limitati dwar it- tossiċità fuq is- sistema riproduttiva ta ’ arsenic trioxide f' bhejjem jindikaw embrijutossiċità u teratoġeniċità (difetti ta ’ tubu newrali, anoftalmija u mikroftalmija) fid- dożi mogħtija ta ’ minn 1 sa 10 darbiet id- doża klinika rakkomandata (mg/ m2).
Fertility studies have not been conducted with TRISENOX.
Ma sarux studju tal- fertililà b’ TRISENOX.
Arsenic compounds induce chromosomal aberrations and morphological transformations of mammalian cells in vitro and in vivo.
Kompownds arseniċi jikkaġunaw aberrazzjonijiet kromosomali u trasformazzjonijiet morfoloġikali ta ’ ċelluli mammaljani in vitro u in vivo.
No formal carcinogenicity studies of arsenic trioxide have been performed.
Ma saru l- ebda studji formali dwar il - karċinoġeniċità ta ’ arsenic trioxide.
However, arsenic trioxide and other inorganic arsenic compounds are recognised as human carcinogens.
Imma, arsenic trioxide u kompownds oħra arseniċi inorganiċi huma meqjusa bħala karkinoġeniċi umani.
sodium hydroxide hydrochloric acid as pH adjuster water for injections
sodium hydroxide hydrochloric acid bħala pH adjuster Ilma għall- injezzjonijiet
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in 6.6.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ 6. 6.
After dilution in intravenous solutions, TRISENOX is chemically and physically stable for 24 hours at 15-30°C and 48 hours at refrigerated (2-8°C) temperatures.
Wara d- dilwazzjoni fis- soluzzjoni fil- vini, TRISENOX hu kemikalment u fiżikament stabbli għal 24 siegħa f’ 15- 30°C u 48 siegħa f’ temperaturi fil- friġġ (2- 8°C).
From a microbiological point of view, the product must be used immediately.
Mill- lant mikrobioloġiku, il- prodott 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 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, iż- żmien u l- kondizzjonijiet tal- ħażna tal - mediċini li għadhom qed jintużaw jaqgħu fuq spallejn min juża l- prodott u normalment m’ għandhomx ikunu ta ’ aktar minn 24 siegħa f’ 2- 8°C, ħlief meta tkun saret id- dilwazzjoni taħt kondizzjonijiet kkontrollati u aseptiċi validati.
Type I borosilicate glass ampoule of 10 ml.
Ampulla Tip 1 tal- ħġieġ borosilikati ta '10 ml.
Each pack contains 10 ampoules.
Kull pakkett fih 10 ampulli.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintremew u għall- immaniġġjar ieħor.
Preparation of TRISENOX
Preparazzjoni ta ’ TRISENOX
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF TRISENOX SINCE NO PRESERVATIVE IS PRESENT.
TRID TINTUŻA B’ MOD STRETT TEKNIKA ASEPTIKA MATUL L– IMMANIĠĠJAR TA ’ TRISENOX GĦAX MA FIH L- EBDA PRESERVATTIV.
TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ ml (5%) injection or sodium chloride 9 mg/ ml (0.9%) injection immediately after withdrawal from the ampoule.
TRISENOX irid ikun dilwit ma ’ injezzjoni ta ’ minn 100 sa 250 ml ta 'glukows 50 mg/ ml (5%) jew injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) hekk kif jinġibed mill- ampulla.
Unused portions of each ampoule must be discarded properly.
Partijiet mhux użati f’ kull ampulla jridu jintremew kif suppost.
Do not save any unused portions for later administration.
Twarrabx kwalunkwe parti li ma kinitx użata biex tingħata aktar tard.
TRISENOX must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
TRISENOX m’ għandux jitħallat ma ’ jew jingħata b’ mod konkomitanti fl- istess linja ġol- vina ma ’ prodotti mediċinali oħra.
11 TRISENOX must be administered intravenously over 1-2 hours.
TRISENOX għandu jingħata fil- vina fuq firxa ta ’ 1- 2 sigħat.
The diluted solution must be clear and colourless.
Is- soluzzjoni dilwita trid tkun ċara u bla kulur.
All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration.
Is- soluzzjonijiet parenterali kollha jridu jkunu spezzjonati viżwalment għall- frak u telf ta ’ kulur qabel ma jingħataw.
Do not use the preparation if foreign particulate matter is present.
Tużax il- preparazzjoni jekk hemm frak.
Procedure for proper disposal
Proċedura ta ’ kif għandu jintrema
Any unused product, any items that come into contact with the product, and waste material must be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża, kwalunkwe affarijiet li għamlu kuntatt mal- prodott jew skart li jibqa ’ wara l- użu għandu jintrema kif jitolbu l- liġijiet lokali.
Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort FRANCE
Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort FRANZA
EU/ 1/ 02/ 204/ 001
UE/ 1/ 02/ 204/ 001
05 March 2002 Date of last renewal:
05 Marzu 2002 Data ta ’ l- aħħar tiġdid:
05 March 2007
05 Marzu 2007
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
13 A DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Almac Pharma Services Limited, Almac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, United Kingdom
Almac Pharma Services Limited, Almac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, Renju Unit
Summary of Product Characteristics, 4.2)
Sommarju tal- Karatteristiċi tal - Prodott, 4. 2)
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- Detentur ta ’ L- awtorizzazzjoni għat- tqegħid fis- suq għandu jtemm il- programm ta ’ studju li ġejjin fiż- żmien speċifikat, u r- riżultati ta 'dawn l- istudji għandhom iservu ta' bażi għall- istima tal- profil bejn il- benefiċċji / riskju li ssir kull sena.
Expected
Meta Huma
Study #
Protokoll
Title
Data ta ’
Protocol
Studju #
Study Start
sottomess
Final Results
Meta Jibda
submitted
Riżultati
date
l- Istudju
and submission
Finali u sottomissjoni
Phase I Study of TRISENOX (arsenic trioxide) injection in Patients with Hepatocellular Carcinoma
Fażi I ta ’ Studju ta ’ injezzjoni ta ’ TRISENOX (arsenic trioxide) f’ Pazjenti b’ Karċinoma Epatoċellulari
November 2001(initial protocol); protocol amendment agreed by CHMP in November 2006
Novembru 2001 (protokoll inizjali); emenda tal - protokoll miftehma mill - CHMP f’ Novembru 2006
January 2002 (on-going)
Jannar 2002 (kontinwu)
December 2008
Diċembru 2008
Phase III randomized study of concurrent tretinoin and chemotherapy with or without arsenic trioxide (As2O3) as initial consolidation therapy followed by maintenance with intermittent tretinoin therapy versus intermittent tretinoin plus mercaptopurine and methotrexate for patients with untreated acute promyelocytic leukemia.
Studju randomised Fażi III ta ’ tretinoin konkurrenti u kemoterapija ma ’ jew mingħajr arsenic trioxide (As2O3) bħala terapija inizjali ta ’ konsolidazzjoni segwita minn
November 2001
Novembru 2001
June 1999
Ġunju 1999
LABELLING
16 A. TIKKETTA
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKET LI JMISS MAL- PRODOTT
{CARTON LABEL}
{LEJBIL TAL- KARTUNA}
TRISENOX 1 mg/ ml, concentrate for solution for infusion Arsenic trioxide
TRISENOX 1 mg/ ml, konċentrat għal solużjoni għall- infużjoni Arsenic trioxide
One ml contains 1 mg of arsenic trioxide
Ml wieħed fih 1 mg ta ’ arsenic trioxide
Other ingredients: sodium hydroxide hydrochloric acid water for injections
Ingredjenti oħra: sodium hydroxide hydrochloric acid ilma għall- injezzjonijiet
concentrate for solution for infusion 10 ampoules of 10 ml (10 mg/ 10 ml)
konċentrat għal soluzzjoni għall- infużjoni 10 ampulli ta '10 ml (10 mg/ 10 ml)
Intravenous use, single use only Must be diluted before use – Read the package leaflet before use
Użu fil- vina, jintuża darba waħda biss Irid ikun dilwit qabel ma jintuża - Aqra l- fuljett ta 'tagħrif qabel l- użu
EXP {MM/ YYYY} Read the leaflet for the shelf-life of the diluted product
JIS {XX/ SSSS} Aqra l- fuljett dwar iż- żmien kemm idum tajjeb il- prodott dilwit
Do not freeze
Tiffriżax
< Justification for not including Braille accepted >
Il- Ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata
{AMPOULE LABEL}
{LEJBIL TA ’ L- AMPULLA}
TRISENOX 1 mg/ ml, concentrate for solution for infusion Arsenic trioxide Intravenous use
TRISENOX 1 mg/ ml, konċentrat għal solużjoni għall- infużjoni Arsenic trioxide Għall- użu fil- vina
Single use only, must be diluted – see leaflet
Użah darba waħda biss, irid ikun dilwit - ara l- fuljett
please tell your doctor or your pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What TRISENOX is and what it is used for 2.
X’ inhu TRISENOX u għalxiex jintuża 2.
Before you use TRISENOX 3.
3.
How to store TRISENOX 6.
Kif taħżen TRISENOX 6.
WHAT TRISENOX IS AND WHAT IT IS USED FOR
X’ INHU TRISENOX U GĦALXIEX JINTUŻA
TRISENOX is used in patients with acute promyelocytic leukaemia (APL) whose disease has not responded to other therapies.
TRISENOX jintuża fil- każ ta ’ pazjenti li jbatu minn lewkimja promijeloċitika akuta (APL) meta l - marda tagħhom ma tirreaġixxix għal terapija oħra.
APL is a unique type of myeloid leukaemia, a disease in which abnormal white blood cells and abnormal bleeding and bruising occur.
APL hi tip uniku ta ’ lewkimja mijelojdi, marda fejn ikun hemm ċelluli bojod abnormali fid- demm u ħruġ abnormali ta 'demm u tbenġil.
BEFORE YOU USE TRISENOX
QABEL MA TUŻA TRISENOX
TRISENOX must be injected under the supervision of a physician experienced in the treatment of acute leukaemias.
TRISENOX irid ikun injettat taħt is- sopervizjoni ta ’ tabib li għandu esperjenza fit- trattament ta ’ lewkimji akuti.
Do not use TRISENOX
Tużax TRISENOX
- if you are hypersensitive (allergic) to arsenic trioxide or any of the other ingredients of
- jekk int tbagħti minn sensittività eċċessiva (allerġiku/ a) għall- arsenic trioxide jew sustanzi oħra ta ’
Take special care with TRISENOX Please tell your doctor immediately if you have any of the following symptoms: shortness of breath, fever, sudden weight gain, fainting, water retention or palpitations (strong heartbeat you can feel in your chest)..
Jekk jogħġbok għid lit- tabib tigħek minnufih jekk ikollok xi wieħed mis- sintomi li ġejjin: qtugħ ta ’ nifs, deni, żjieda f’ daqqa fil- piż, iħossok ħass ħażin, ikun hemm żamma ta ’ l- ilma jew palpitazzjonijiet (taħbit qawwi tal- qalb li tħoss f’ sidrek).
Your doctor must check your blood to be sure that you do not have low amounts of potassium or magnesium before your first dose of TRISENOX.
It- tabib tiegħek irid jiċċekkja demmek biex ikun żgur li int m' għandekx ammonti baxxi ta 'potassju jew manjesju qabel ma tieħu l- ewwel doża tiegħek ta' TRISENOX.
You should also have a 12-lead electrocardiogram performed before your first dose.
Int għandek tmur għal elektrokardjogramm ta ’ 12- lead qabel l- ewwel doża tiegħek.
Blood tests should be repeated twice weekly while you are receiving TRISENOX.
Testijiet tad- demm għandhom ikunu ripetuti darbtejn fil- ġimgħa waqt li tkun qed tieħu TRISENOX.
In addition, you will receive electrocardiograms twice weekly.
Barra minn dan, int ser tmur għall - elektrokardjogrammi darbtejn fil- ġimgħa.
If you are at risk for a certain type of abnormal heart rhythm (e. g. torsade de pointes or QTc prolongation) your heart will be monitored continuously.
Jekk int tinsab f’ riskju ta ’ certu tip ta ’ ritmu abnormali tal - qalb (eż. torsade de pointes jew prolongazzjoni QTc) qalbek ser tkun immonitorjata l- ħin kollu.
You must tell your doctor if you have impaired kidney or liver function.
Għandek tgħid lit- tabib tiegħek jekk għandek indeboliment fil- funzjoni tal- kliewi jew tal- fwied.
These include:
Meta tuża mediċini oħra:
some types of antiarrhythmics (drugs used to correct irregular heart beats, e.g.
Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu xi wieħed mid- diversi tipi ta ’ mediċini li jistgħu jikkawżaw bidla fir- ritmu tat- taħbit tal- qalb tiegħek.
quinidine, amiodarone, sotalol, dofetilide)
Dawn jinkludu: xi tipi ta ’ mediċini kontra l- arritmija (mediċini wżati biex jiġi kkoreġut taħbit •
• •
irregolari tal- qalb, eż. quinidine, amiodarone, sotalol, dofetilide) antipsikotiċi (eż. thioridazine) •
antipsychotics (e.g. thioridazine) antidepressants (e.g. amitriptyline) 22
22 antidepressanti (eż. amitriptyline) •
• •
xi tipi ta ’ antibijotiċi (eż. erythromycin u sparfloxacin) •
•
xi antistaminiċi (eż. terfenadine u astemizole) •
some types of antibiotics (e.g. erythromycin and sparfloxacin) some antihistamines (e.g. terfenadine and astemizole) any medicines that cause a decrease in magnesium or potassium in your blood (e.g.
kull mediċina li tikkawża tnaqqis ta ’ magnesium jew potassium fid- demm tiegħek •
cisapride (a medicine used to relieve certain stomach problems).
(eż. amphotericin B) cisapride (mediċina wżata biex tikkura ċertu problemi fl- istonku). •
The effect of these medicines on your heartbeat can be made worse by TRISENOX.
L- effett ta ’ dawn il- mediċini fuq it- taħbit tal- qalb tiegħek jista ’ jaggrava permezz ta ’ TRISENOX.
You must be sure to tell your doctor about all medicines you are taking.
Għandek tkun ċert/ ċerta li tgħid lit- tabib tiegħek dwar kull mediċina li qed tieħu.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Using TRISENOX with food and drink
Meta tuża TRISENOX ma ’ l- ikel u max- xorb
- no restrictions on your food or drink are needed while you are receiving TRISENOX.
- m' hemmx bżonn ta 'restrizzjonijiet fuq l- ikel u x- xorb tiegħek waqt li tkun qed tieħu
Pregnancy
TRISENOX.
TRISENOX may cause harm to the foetus when used by pregnant women.
TRISENOX għandu mnejn jagħmel ħsara fil- fetu meta jkun użat minn nisa tqal.
If you are able to become pregnant, you must use effective birth control during treatment with TRISENOX.
Jekk int tista 'ssir tqila, int trid tieħu kontraċettivi effettivi waqt it- trattament b’ TRISENOX.
If you are pregnant or you become pregnant during the treatment with TRISENOX, you must ask your doctor for advice.
Jekk int tqila jew sirt tqila matul it- trattament b’ TRISENOX, int trid titlob il- parir tat- tabib tiegħek.
Men should also use effective contraception during treatment with TRISENOX.
L- irġiel għandhom jużaw ukoll mezz ta ’ kontraċezzjoni li hu effettiv matul it- trattament b’ TRISENOX
Arsenic will be present in the milk of TRISENOX patients who are breast-feeding.
L- arseniku ser ikun preżenti fil- ħalib ta ’ pazjenti li qed jieħdu TRISENOX u li qed ireddgħu.
Because of the potential for serious side-effects in nursing infants from TRISENOX, do not breast-feed while on TRISENOX.
Peress li hemm potenzjal ta ’ effetti sekondarji serji fil- każ ta ’ trabi li qed jieħdu ż- żejża kaġun ta ’ TRISENOX, treddax waqt li tkun qed tieħu TRISENOX.
The effect of TRISENOX on your ability to drive is not known.
L- effett ta ’ TRISENOX fuq il- ħila tiegħek li ssuq mhux magħruf.
If you experience discomfort or if you feel unwell after a TRISENOX injection, you should wait until the symptoms go away before driving or using machines.
Jekk int tħoss xi problema jew tħossok ma tiflaħx wara injezzjoni ta ’ TRISENOX, int għandek tistenna sakemm is- sintomi jgħaddu qabel ma tibda ssuq jew tħaddem il- magni.
Important information about some of the ingredients of TRISENOX
Tagħrif importanti dwax xi wħud mis- sustanzi ta ’ TRISENOX
Trisenox contains less than 1 mmol sodium (23 mg) per dose i.e. essentially ‘sodium-free’.
Trisenox fih inqas minn 1 mmol sodium (23 mg) kull doża i. e. essenzjalment “ mingħajr sodium ”.
HOW TO USE TRISENOX
KIF GĦANDEK TUŻA TRISENOX
Your doctor will dilute TRISENOX with 100 to 250 ml of glucose 50 mg/ml (5%) injection, or sodium chloride 9 mg/ml (0.9%) injection.
It- tabib tiegħek ser jiddilwa TRISENOX ma ’ injezzjoni ta ’ minn 100 sa 250 ml ta ’ glukows 50 mg/ ml (5%), jew injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
Your doctor will infuse TRISENOX through a tube into a blood vessel over 1-2 hours, but the infusion may last longer if side-effects like flushing and dizziness occur.
It- tabib tiegħek ser jinfuża TRISENOX minn ġo tubu fil- vina tad- demm fuq perijodu ta ’ minn siegħa sa sagħtejn, imma l- infużjoni għandha mnejn tieħu aktar żmien jekk ikun hemm effetti sekondarji bħal ħmura fil- wiċċ jew sturdament.
Your doctor will give you TRISENOX once every day as a single infusion each day.
It- tabib tiegħek ser jagħtik TRISENOX darba kuljum bħala infużjoni waħda kuljum.
In your first treatment cycle, you may be treated every day up to 50 days at most, or until your doctor determines that your disease is better.
Fl- ewwel ċiklu tiegħek ta ’ trattament, int għandek mnejn tkun ikkurat kuljum għal mhux aktar minn 50 ġurnata, jew sakemm it- tabib tiegħek jiddeċiedi li l- marda tiegħek qalbet għall- aħjar.
If your disease responds to TRISENOX, you will be given a second treatment cycle of 25 doses, one infusion every weekday for 5 weeks.
Jekk il- marda tiegħek tirreaġixxi għal TRISENOX, int ser tingħata t- tieni ċiklu ta ’ trattament ta ’ 25 doża, infużjoni waħda
Your doctor will decide exactly how long you must continue on therapy with TRISENOX.
It- tabib tiegħek ser jiddeċiedi eżattament kemm għandek tkompli tingħata t- terapija b’ TRISENOX
Each TRISENOX ampoule must be used only once and does not contain any preservatives.
Kull ampulla ta ’ TRISENOX trid tintuża darba waħda biss u ma fihiex preservattivi.
23 Do not save any unused portions for later use.
Twarrabx kwalunkwe parti li ma kinitx użata biex tingħata aktar tard.
TRISENOX must not be mixed with, or infused through the same tube with other medicinal products.
TRISENOX m’ għandux jitħallat ma ’, jew ikun infużat mill- istess tubu ma ’ prodotti mediċinali oħra.
If your doctor gives you more TRISENOX than he/she should
Jekk it- tabib tiegħek jagħtik TRISENOX aktar milli suppost
You may experience convulsions, muscle weakness and confusion.
Int għandek mnejn ikollok konvulsjonijiet, indebboliment muskolari u konfużjoni.
If this happens, treatment with TRISENOX must be stopped immediately and your doctor will treat the arsenic overdose.
Jekk jiġri dan, it - trattament b’ TRISENOX irid jitwaqqaf minnufih u t- tabib tiegħek ser jikkura d- doża eċċessiva arsenika.
Like all medicines, TRISENOX can have side effects.
Bħal kull mediċina oħra, TRISENOX jista ’ jkollu effetti sekondarji.
While on treatment with TRISENOX, you may experience some of the following reactions: common side effects (greater than or equal to 1 in 100 but less than 1 in 10): fatigue (weariness), increased blood sugar, shortness of breath, cough, headache. uncommon side effects (greater than or equal to 1 in 1000 but less than 1 in 100): increased white blood cell count, Herpes zoster, pneumonia, sepsis, anaemia, dehydration, confusion, blurry vision, cardiac failure, hypotension, pneumonitis, chills, renal failure, increased weight, nausea, vomiting, diarrhoea, stomach ache, oedema (water retention), rash or itching, change in your heart rhythm or dizziness.
Waqt li tkun qed tingħata l- kura b’ TRISENOX, int għandek mnejn tħoss wieħed mir- reazzjonijiet li ġejjin: effetti sekondarji komuni (aktar minn jew daqs 1 fil- 100 imma inqas minn 1 f' 10) għeja (għeja), żjieda fiż- żokkor fid- demm, qtugħ ta 'nifs, sogħla, uġigħ ta ’ ras. effetti sekondarji mhux komuni (aktar minn jew daqs 1 f’ 1000 imma inqas minn 1 fil- 100): numru ogħla ta ’ ċelluli bojod fid- demm, Herpes zoster, pnewmonja, sepsi, anemija, deidratazzjoni, konfużjoni, vista mċajpra, falliment kardijaku, pressjoni baxxa, pnewmonite, kesħa, insuffiċjenza renali, żjieda fil- piż, tqallih, rimettar, dijarea, uġigħ fl- istonku, edima (akkumulazzjoni ta ’ l- ilma), raxx jew ħakk, bidla fir- ritmu ta ’ qalbek jew sturdament.
Frequency unknown: decreased blood cell counts, a syndrome including fever, together with difficulty in breathing, coughing and chest pain.
Frekwenza mhux magħrufa: tnaqqis fl- għadd ta ’ ċelluli tad- demm, sindrome li tinkludi deni flimkien ma ’ diffikultà biex tieħu n- nifs, sogħla u uġigħ fis- sider.
If you experience these symptoms, you should inform your doctor immediately.
Jekk ikollok esperjenza ta ’ dawn is- sintomi, għandek tgħarraf lit- tabib tiegħek minnufih.
Other side effects not mentioned above may also occur in some patients.
Xi pazjenti għandu mnejn iħossu effetti sekondarji oħra li ma ġewx imsemmija hawn fuq.