qanastek/EMEA-V3 huggingface dataset:
94 Don’ t stop using Arixtra without advice If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the lung.
Jekk twaqqaf it- trattament qabel ma jgħidlek it- tabib, l- għoqda tad- demm tista ’ ma tkunx ittrata sew u inti jista ’ jkollok ukoll ir- riskju li tiżviluppa għoqda tad- demm ġdida f’ vina tar- riġel jew fil- pulmun.
If you have any further questions about how to use this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet kif tuża ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Common side effects These may affect more than 1 in 100 people treated with Arixtra. • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, bruising)
Effetti sekondarji komuni Dawn jistgħu jaffettwaw iżjed minn wieħed kull 100 persuna trattati b’ Arixtra • ħruġ ta ’ demm (per eżempju mis- sit ta ’ operazzjoni, ulċera fl- istonku diġa ’ eżistenti, fġir l - imnieħer, tbenġil).
Uncommon side effects These may affect up to 1 in 100 people treated with Arixtra. • swelling (oedema) • headache • pain • feeling sick or being sick (nausea or vomiting) • low number of red blood cells (anaemia) • low number of platelets (blood cells necessary for blood clotting) • increase in some chemical (enzymes) produced by the liver
Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa wieħed minn kull 100 persuna trattati b’ Arixtra • nefħa (edima) • uġigħ ta ’ ras • uġigħ • tħossok imqalla jew titqalla (dardir jew rimettar) • numru baxx ta ’ ċelloli ħomor fid- demm (anemija) • numru baxx ta ’ plejtlets (ċelloli tad- demm neċessarji biex jagħqad id- demm) • żieda f’ xi kemikali (enżimi) li jsiru fil- fwied.
Rare side effects These may affect up to 1 in every 1000 people treated with Arixtra. • allergic reaction • internal bleeding in the brain, liver or abdomen • rash • dizziness • pain and swelling at injection site • high number of platelets (blood cells necessary for blood clotting) • increase in the amount of non-protein nitrogen in the blood
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa 1 minn kull 1000 persuna trattati b’ Arixtra • reazzjoni allerġika • ħruġ ta ’ demm internament fil- moħħ, fwied jew addomenu • raxx • sturdament • uġigħ u nefħa fil- post ta ’ injezzjoni • numru għoli ta ’ plejtlets (ċelloli tad- demm neċessarji biex jagħqad id- demm) • żieda fin- nitroġenu mhux minn proteini fid- demm
If you get side effects → Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Jekk ikollok effetti mhux mixtieqa →Għid lit- tabib jew l- ispiżjar tiegħek jekk xi wieħed mill- effetti sekondarji jiggrava jew jagħtik fastidju jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett.
HOW TO STORE ARIXTRA • Keep out of the reach and sight of children • Do not freeze • Arixtra does not have to be kept in the fridge.
KIF TAĦŻEN ARIXTRA • Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal • Tiffriżahx • Arixtra m’ għandux għalfejn jinżamm fil- friġġ
Do not use Arixtra: • after the expiry date stated on the label and carton • if you notice any particles in the solution, or if the solution is discoloured • if you notice that the syringe is damaged • if you have opened a syringe and you do not use it straightaway.
Tużax Arixtra: • wara d- data ta ’ skadenza li tidher fuq it- tabella u l- kaxxa. • jekk tara xi frak fis- soluzzjoni jew jekk is- soluzzjoni titlef il- kulur • jekk tara illi s- siringa għandha xi ħsara; • jekk ftaħt siringa u ma tużahiex minnufih.
Medicines and syringes should not be disposed of via wastewater or household waste.
98 Rimi ta ’ siringi Mediċini u siringi m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Arixtra contains The active substance is: • 5 mg fondaparinux sodium in 0.4 ml solution for injection • 7.5 mg fondaparinux sodium in 0.6 ml solution for injection • 10 mg fondaparinux sodium in 0.8 ml solution for injection
X’ fiha Arixtra Is- sustanza attiva hija • 5 mg ta ’ fondaparinux sodium f’ 0. 4 ml ta ’ soluzzjoni għall- injezzjoni • 7. 5 mg ta ’ fondaparinux sodium f’ 0. 6 ml ta ’ soluzzjoni għall- injezzjoni • 10 mg ta ’ fondaparinux sodium f’ 0. 8 ml ta ’ soluzzjoni għall- injezzjoni
The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/ or sodium hydroxide to adjust the pH.
Is- sustanzi l- oħra huma sodium chloride, ilma għal injezzjonijiet, u hydrochloric acid u jew sodium hydroxide biex jaġġustaw il- pH.
What Arixtra looks like and contents of the pack Arixtra is a clear and colourless to slightly yellow solution for injection.
Arixtra hija soluzzjoni għal injezzjoni ċara, mingħajr kulur jew tagħti xi ftit fl- isfar.
It is supplied in a pre-filled syringe fitted with a safety system to help prevent needle stick injuries after use.
Hija fornita f’ siringa mimlija lesta, għall- użu ta ’ darba u mgħammra b’ sistema ta ’ sikurezza awtomatika sabiex tipprevjeni ferimenti bil- labra wara l- użu.
96 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
99 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
97 Italia GlaxoSmithKline S. p. A.
100 Italia GlaxoSmithKline S. p. A.
98 Types of safety syringe There are two types of safety syringes used for Arixtra, designed to protect you from needle stick injuries following injection.
101 Tipi ta ‘ siringa ta ’ sikurezza Hemm żewġ tipi ta ’ siringi ta ’ sikurezza għal Arixtra iddisinjati biex jipproteġuk milli tweġġa mill - labra wara injezzjoni.
STEP BY STEP GUIDE TO USING ARIXTRA
GWIDA PASS- PASS TA ’ KIF TUŻA ARIXTRA
Remove the syringe from the carton and check that: • the expiry date has not passed • the solution is clear and colourless to slightly yellow and doesn’ t contain particles
Neħħi s- siringa minn ġol- kaxxa w ara li:
99
• • •
•
d- data ta ’ skadenza m’ għadditx s- soluzzjoni hija ċara w bla kulur u ma fihiex frak s- siringa ma nfetħitx jew għandha xi ħsara
the syringe has not been opened or damaged
102
Clean the injection area with an alcohol wipe.
Naddaf iż- żona ta ’ l- injezzjoni b’ biċċa bl- alkoħol.
Remove the needle guard, by first twisting it (picture B1), and then pulling it in a straight line away from the body of the syringe (picture B2).
Neħħi l- apparat protettiv tal- labra, billi l- ewwel iddawwar (figura B1) imbagħad tiġbdu f’ linja dritta lil hinn miċ- ċilindru tas- siringa (figura B2).
Picture B1
Tippruvax tneħħi din il- bużżieqa Figura B1 ta ’ l- arja qabel ma tagħmel l- injezzjoni - tista ’ titlef xi ftit mill- mediċina jekk tagħmel hekk.
Inject ALL of the contents of the syringe by pressing down on the plunger as far as it goes (picture E).
Figura E Sistema awtomatika ta ’ siringa
This is shown in Picture 3 at the beginning of these instructions
Din tidher fi Stampa 3 fil- bidu ta ’ dawn l- istruzzjonijiet.
What is Atriance?
X' inhu Atriance?
Atriance is a solution for infusion.
Atriance huwa soluzzjoni għal infużjoni.
It contains the active substance nelarabine.
Fih is- sustanza attiva nelarabine.
What is Atriance used for?
Għal x' hiex jintuża Atriance?
Atriance is used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Atriance jintuża biex jittratta pazjenti b' T- cell acute lymphoblastic leukaemia (T- ALL) jew b' T- cell lymphoblastic lymphoma (T- LBL).
These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly.
Dawn huma tipi ta 'kanċer fejn it- T- lymphoblasts (tip ta' ċellola tad- demm bajda immatura) jimmultiplikaw malajr wisq.
In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland).
F' T- ALL, iċ- ċelloli anormali huma prinċipalment fid- demm u fil- mudullun ta 'l- għadam, u f' T- LBL dawn huma prinċipalment fis- sistema limfatika (glandola limfatika jew il- glandola tat- timu).
Atriance is used when patients have failed to respond to, or have stopped responding to at least two types of chemotherapy.
Atriance jintuża meta l- pazjenti ma jkunux wieġbu għal, jew ma jibqgħux jirrispondu għal mill- inqas żewġ tipi ta 'kimoterapija.
The medicine can only be obtained with a prescription.
Minħabba li l- għadd ta 'pazjenti b' dan it- tip ta' mard huwa wieħed baxx, il- mard huwa meqjus 'rari' u Atriance ġie propost bħala 'mediċina orfni' (mediċina użata fil- mardiet rari) fis- 16 ta 'Ġunju 2005 Il- mediċina tista' tinkiseb biss b' riċetta ta 'tabib.
How is Atriance used?
Kif jintuża Atriance?
Atriance is given by intravenous infusion (a drip into a vein) under the supervision of a doctor who has experience in the use of these types of medicine.
Atriance jingħata bħala infużjoni ġol- vini (dripp ġol- vini) taħt is- sorveljanza ta 'tabib li għandu esperjenza fl- użu ta' dawn it- tipi ta 'mediċini.
The dose and frequency of infusion depend on the patient ’ s age and body surface area.
Id- doża u l- frekwenza ta 'l- infużjoni jiddependu fuq l- età tal- pazjent u s- superfiċje tal- ġisem.
In adults and adolescents aged over 16 years, the recommended starting dose is 1,500 mg per square metre, given over two hours on days 1, 3 and 5, repeated every 21 days.
Fl- adulti u fl- adoloxxenti li għandhom iktar minn 16- il sena, id - doża tal- bidu rrakkomandata hija ta '1, 500 mg għal kull metru kwadru, mogħtija fuq sagħtejn fil- jiem 1, 3 u 5, ripetuta kull 21 jum.
Younger patients receive a lower dose (650 mg per square metre) given over one hour on five consecutive days, repeated every 21 days.
Pazjenti iżgħar jirċievu doża iżgħar (650 mg għal kull metru kwadru) mogħtija fuq siegħa matul ħamest ijiem konsekuttivi, ripetuta kull 21 jum.
This schedule can also be used in patients aged 16 to 21 years.
Din l- iskeda tista 'tintuża wkoll f' pazjenti ta' età bejn 16 u 21 sena.
Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system.
It- trattament għandu jitwaqqaf jekk il- pazjent jiżviluppa effetti sekondarji serji li jaffettwaw il- moħħ jew is- sistema nervuża.
Patients receiving Atriance should be monitored regularly for changes in blood counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Pazjenti li qed jirċievu Atriance għandhom jiġu mmonitorjati regolarment għal bidliet fl- għadd tad - demm u għandhom jirċievu idratazzjoni adegwata jekk ikunu f' riskju tas- sindromu ta 'tumour lysis (komplikazzjoni dovuta għat- tkissir taċ- ċelloli tal- kanċer).
Patients who have problems with their kidneys should be closely monitored for side effects during Atriance treatment.
Pazjenti li għandhom problemi bil- kliewi tagħhom għandhom jiġu mmonitorjati mill- qrib għal effetti sekondarji matul trattatment b' Atriance.
Atriance should be used with caution in patients with liver problems.
Atriance għandu jintuża b' attenzjoni f' pazjenti bi problemi tal- fwied.
How does Atriance work?
Kif jaħdem Atriance?
The active substance in Atriance, nelabarine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Is- sustanza attiva f' Atriance, nelabarine, hija ċitotossika, mediċina li toqtol ċelloli li qegħdin jinqasmu, bħal ċelloli tal- kanċer.
It belongs to the group of anti-cancer medicines called ‘ antimetabolites’.
Tappartieni għall- grupp ta 'mediċini kontra l- kanċer imsejħa ‘ antimetaboliti ’.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Nelarabine is converted within cells to an analogue of guanine, one of the fundamental chemicals that make up DNA.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Nelarabine jinbidel fiċ- ċelloli għal analogue ta 'guanine, waħda mill- kimiċi fundamentali li jiffurmaw id- DNA.
In the body, this active analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases.
Fil- ġisem, dan l- analogue attiv jieħu post guanine u jinterferixxi ma 'l- enzimi involuti fl - għemil ta' DNA, DNA polymerases ġodda.
This stops the production of DNA and thus slows down the growth and multiplication of tumour cells.
Dan iwaqqaf il- produzzjoni tad- DNA u b' hekk jitnaqqas it - tkabbir u l- multiplikazzjoni taċ- ċelloli tat- tumur.
As the active guanine analogue accumulates in T-cells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.
Minħabba li l- guanine analogue attiv jakkumula f' T - cells u jdum iktar f' dawn iċ- ċelloli, Atriance inaqqas it- tkabbir u l- multiplikazzjoni taċ- ċelloli involuti f' T- ALL u f' T- LBL.
How has Atriance been studied?
Kif ġie studjat Atriance?
The effects of Atriance were first tested in experimental models before being studied in humans.
L- effetti ta 'Atriance ġew l- ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Atriance has been studied in two main studies of patients with T-ALL and T-LBL who had stopped responding to one or more previous anticancer treatments.
Atriance ġie studjat f' żewġ studji prinċipali ta 'pazjenti b' T- ALL u b' T- LBL li ma baqgħux jirrispondu għal trattament wieħed jew aktar kontra l- kanċer preċedenti.
The first study involved a total of 70 children and young adults aged below 21 years, and the second involved a total of 40 adults and adolescents aged over 16 years.
L- ewwel studju kien jinvolvi total ta '70 tifel/ tifla u żgħażagħ taħt il- 21 sena, u t- tieni kien jinvolvi total ta' 40 adult u adoloxxent ta 'aktar minn 16- il sena.
Around half of the patients had failed two or more previous treatments.
Madwar nofs il- pazjenti ma għaddewx minn żewġ trattamenti preċedenti jew aktar.
In both studies, the patients were treated with Atriance, but its effects were not compared with those of any other medicine.
Fiż - żewġ studji, il- pazjenti ġew ittrattati b' Atriance, madankollu, l- effetti tiegħu ma ġewx imqabbla ma 'dawk ta' mediċina oħra.
The main measure of effectiveness was the proportion of patients who responded to treatment, defined as no evidence of disease and recovery of blood cell counts, within a month of starting Atriance treatment.
Il- kejl ewlieni ta 'l- effikaċja kien il- proporzjon ta' pazjenti li wieġbu għat - trattament, definiti bħala ebda evidenza tal- marda u rkupru ta 'l- għadd taċ- ċelloli tad- demm, fi żmien xahar mill- bidu tat- trattament b' Atriance.
What benefit has Atriance shown during the studies?
X' benefiċċji ta 'Atriance intwerew f' dawn l- istudji?
Atriance was shown to be effective in a proportion of the patients in both studies.
Atriance intwera li kien effettiv fi proporzjon tal- pazjenti fiż- żewġ studji.
In the first study, among the 39 children and young adults who had failed two or more previous treatments, five (13%) had a complete response to treatment after a month, with no evidence of disease and normal blood counts.
Fl- ewwel studju, fost id- 39 tifel/ tifla u żgħażagħ li ma għaddewx minn żewġ trattamenti preċedenti jew aktar, ħamsa (13%) kellhom rispons sħiħ għat- trattament wara xahar, mingħajr ebda evidenza ta 'mard u għadd tad- demm normali.
In the second study, among the 28 adults and adolescents who had failed two or more previous treatments, five (18%) had a complete response to treatment.
Fit- tieni studju, fost it- 28 adult u adoloxxenti li ma għaddewx minn żewġ trattamenti preċedenti jew aktar, ħamsa (18%) kellhom rispons sħiħ għat- trattament.
In both studies, more patients had a partial response to Atriance treatment, with blood counts returning towards normal levels.
Fiż- żewġ studji, aktar pazjenti kellhom rispons parzjali għat- trattament b' Atriance, bl- għadd tad- demm imorru lura għal - livelli normali.
What is the risk associated with Atriance?
X' inhu r- riskju assoċjat ma 'Atriance?
The most common side effects with Atriance in adults (seen in more than 1 patient in 10) are infection, febrile neutropenia (low white blood cell counts with fever), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoesthesia (a reduced sense of touch), paresthesia (abnormal sensations), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), oedema (swelling), pyrexia (fever), pain, fatigue (tiredness) and asthenia (weakness).
L- aktar effetti sekondarji komuni b' Atriance fl- adulti (jidhru f' iktar minn pazjent 1 minn kull 10) huma infezzjoni, newtropenja bid- deni (għadd baxx ta 'ċelloli tad- demm bojod bid- deni), newtropenja (għadd baxx ta' ċelloli tad- demm bojod), tromboċitopenja (għadd baxx ta 'pjastrini), anemija (għadd baxx ta' ċelloli tad- demm bojod), ħedla (ngħas), newropatija periferali (ħsara għan- nervituri fl - estremitajiet), ipoestesija (sens ta 'ħass imnaqqas), parestesija (sensazzjonijiet anormali), sturdament, uġigħ ta' ras, dispnea (qtugħ ta 'nifs), sogħla, dijarrea, rimettar, kostipazzjoni, nawsja (dardir), mijalġja (uġigħ muskolari), edema (nefħa), pyrexia (deni), uġigħ, għejja u astenja (dgħjufija).
Most of these side effects were also seen very commonly in children.
Ħafna minn dawn l- effetti sekondarji dehru wkoll b' mod komuni ħafna fuq it- tfal.
For the full list of all side effects reported with Atriance, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Atriance, ara l- Fuljett ta 'Tagħrif.
Severe side effects affecting the brain and nervous system have been reported in patients taking Atriance, including somnolence, convulsions, and peripheral neuropathy causing numbness, unusual sensations, weakness and even paralysis.
Effetti sekondarji serji li jaffettwaw il- moħħ u s- sistema nervuża ġew irrapportati f' pazjenti li qegħdin jieħdu Atriance, inkluż ħedla, konvulżjonijiet u newropatija periferali li tikkawża tirżiħ, sensazzjonijiet mhux normali, dgħjufija u anki paraliżi.
Patients should be monitored closely for these side effects and treatment stopped if necessary.
Il- pazjenti għandhom jiġu mmonitorjati mill - qrib għal dawn l- effetti sekodarji u t- trattament għandu jitwaqqaf jekk ikun hemm bżonn.
Atriance should not be used in people who may be hypersensitive (allergic) to nelarabine or any of the other ingredients.
Atriance m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal nelarabine jew għal xi sustanza oħra tiegħu.
Why has Atriance been approved?
Għaliex ġie approvat Atriance?
The Committee for Medicinal Products for Human Use (CHMP) noted that, due to the small number of patients with these diseases, the information to support the approval of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive a bone marrow transplant, increasing their chances of survival.
Il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) innota li, minħabba n- numru żgħir ta 'pazjenti b' dan il- mard, l- informazzjoni biex tkun appoġġjata l- approvazzjoni ta' Atriance hija limitata, iżda qabel li l- mediċina tista 'tippermetti lil xi pazjenti sabiex jirċievu trapjant tal- mudullun ta' l- għadam, u b' hekk jiżdiedu ċ- ċansijiet ta 'għajxien tagħhom.
Therefore, the Committee decided that Atriance’ s benefits are greater than its risks for the treatment of patients with T-ALL and T-LBL whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Għaldaqstant, il- Kumitat iddeċieda li l- benefiċċji ta 'Atriance huma akbar mir- riskji tiegħu għat- trattament ta' pazjenti b' T- ALL u b' T- LBL li l- marda tagħhom ma weġbitx għal, jew marret għall- agħar, wara trattament b' għallinqas żewġ kimoterapiji differenti.
The Committee recommended that Atriance be given marketing authorisation.
Il- Kumitat irrakkomanda li Atriance jingħata awtorizzazzjoni għat- tqegħid fis - suq.
Atriance has been authorised under “ Exceptional Circumstances”.
Atriance kien awtorizzat taħt "Ċirkustanzi ta 'Eċċezzjoni".
This means that because the diseases are rare, it has not been possible to obtain complete information about Atriance.
Dan ifisser li minħabba li l- mard huwa rari, ma kienx possibbli li jinġabar it- tagħrif kollu dwar Atriance.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea dwar il -
What information is still awaited for Atriance?
X' tagħrif dwar Atriance għadu mistenni?
The company that makes Atriance will supply information from studies into the safety of Atriance in children and young adults, including one study of Atriance taken in combination with other anticancer medicines.
Il- kumpanija li tagħmel Atriance se tagħti informazzjoni minn studji dwar is- sigurtà ta 'Atriance fi tfal u żgħażagħ, inkluż studju wieħed ta' Atriance meħud f' kombinazzjoni ma 'mediċini oħra kontra l - kanċer.
Other information about Atriance:
Tagħrif ieħor dwar Atriance:
The European Commission granted a marketing authorisation valid throughout the European Union for Atriance to Glaxo Group Limited on 22 August 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Atriance valida fl- Unjoni Ewropea kollha lil Glaxo Group Limited fl- 22 ta 'Awwissu 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Atriance is available here.
Is- sommarju ta 'l- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni dwar Atriance jista' jinstab hawn.
The full EPAR for Atriance can be found here.
L- EPAR sħiħ għal Atriance jinstab hawn.
This summary was last updated in 07-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' 07- 2007.
EU Number EU/ 1/ 07/ 403/ 001
Numru ta ’ l- EU EU/ 1/ 07/ 403/ 001
Invented name Atriance
Isem inventat Atriance
Strength 5 mg/ ml
Qawwa 5 mg/ ml
Pharmaceutical Form Solution for infusion
Għamla Farmaċewtika Soluzzjoni għal infużjoni
Route of Administration Intravenous use
Mnejn jingħata Użu mill- vina
Packaging vial (glass)
Il- Pakkett fjala (ħġieġ)
Content 50 ml
Kontenut 50 ml
Package size 6 vials
Daqs tal- pakkett 6 fjali
Atriance 5 mg/ ml solution for infusion
Atriance 5 mg/ ml soluzzjoni għall- infużjoni
Each ml contains 5 mg of nelarabine.
Kull ml fih 5 mg ta 'nelarabine.
Each vial contains 250 mg of nelarabine.
Kull fjala fiha 250 mg ta 'nelarabine.
Each ml contains 1.725 mg (75 micromols) of sodium.
Kull ml fih 1. 725 mg (75 micromols) ta 'sodju.
Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
4. 1 Indikazzjonijiet terapewtiċi
Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Minħabba l- popolazzjoni żgħira ta 'pazjenti b' dan it- tip ta' mard, l- informazzjoni li ssostni dawn l- indikazzjonijiet hija bbażata fuq tagħrif limitat.
Nelarabine is for intravenous use only and must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Nelarabine qiegħed biss għall- użu ġol- vini u għandu jingħata biss taħt sorveljanza ta 'tabib b' esperjenza fl- użu ta' sustanzi ċitotossiċi.
Nelarabine is not diluted prior to administration.
Nelarabine ma jkunx dilwit qabel ma jiġi amministrat.
The appropriate dose of nelarabine is transferred into polyvinylchloride (PVC) or ethyl vinyl acetate (EVA) infusion bags or glass containers and administered as a two-hour infusion in adult patients and as a one-hour infusion in paediatric patients.
Id- doża adatta ta 'nelarabine tiġi trasferita f' boroż ta' infużjoni ta 'polyvinylchloride (PVC) jew ethyl- vinyl- acetate (EVA) jew kontenituri tal- ħġieġ u tingħata bħala infużjoni fuq sagħtejn f' pazjenti adulti u bħala infużjoni fuq siegħa f' pazjenti pedjatriċi.
Complete blood counts including platelets must be monitored regularly (see sections 4.4 and 4.8).
Għandu jiġi monitorjat regolarment l- għadd komplet taċ- ċelluli tad- demm inklużi l- plejtlets (ara sezzjonijiet 4. 4 u 4. 8).
Patients receiving nelarabine are recommended to receive intravenous hydration according to standard medical practice for the management of hyperuricemia in patients at risk for tumour lysis syndrome.
Hu rrakkomandat li pazjenti li jingħataw nelarabine għandhom jingħataw idratazzjoni minn ġol- vina skond il- prattika medika standard għall- immaniġġjar ta 'iperuriċemija f' pazjenti b' riskju tas- sindrome ta' diżintegrazzjoni tat- tumur.
For patients at risk of hyperuricemia, the use of allopurinol should be considered (see section 4.4).
L- użu ta 'allopurinol għandu jiġi kkunsidrat f' pazjenti b' riskju ta' iperuriċemija (ara sezzjoni 4. 4).
Adults and adolescents (aged 16 years and older)
2 Adulti u adolexxenti (eta 'ta' 16- il sena u aktar)
2 The recommended dose of nelarabine for adults is 1,500 mg/ m2 administered intravenously over two hours on days 1, 3 and 5 and repeated every 21 days.
Id- doża rakkomandata ta 'nelarabine fl- adulti hija 1, 500 mg/ m2 li tingħata f' sagħtejn ġol- vina f' ewwel, fit- tielet u fil- ħames jum b' ripetizzjoni kull 21 ġurnata.
Children and adolescents (aged 21 years and younger)
Tfal u adolexxenti (eta 'ta' 21- il sena u iżgħar)
The recommended dose of nelarabine for children is 650 mg/ m2 administered intravenously over one hour daily for 5 consecutive days, repeated every 21 days.
Id- doża rakkomandata ta 'nelarabine fit- tfal hija ta' 650 mg/ m2 li tingħata ġol- vina fuq siegħa kuljum għal ħamest ijiem konsekuttivi b' ripetizzjoni kull 21 ġurnata.
In clinical studies, the 650 mg/ m2 and 1,500 mg/ m2 dose have both been used in patients in the age range 16 to 21 years.
Fi studji kliniċi, kemm id- doża ta '650 mg/ m2 kif ukoll id- doża ta' 1, 500 mg/ m2 intużaw f' pazjenti bejn l- eta 'ta' 16 u 21 sena.
Efficacy and safety were similar for both regimens.
L- effikaċa u s- sigurta 'kienu l- istess fiż- żewġ sistemi.
The prescribing physician should consider which regimen is appropriate when treating patients in this age range.
It- tabib li jippreskrivi għandu jikkunsidra liema sistema hija adatta meta jikkura pazjenti f' din l- eta '
Limited clinical pharmacology data are available for patients below the age of 4 years.
M’ hemmx tagħrif kliniku biżżejjed dwar pazjenti li għandhom anqas minn 4 snin.
Dose modification
Bidla fid- doża
Nelarabine must be discontinued at the first sign of neurological events of National Cancer Institute Common Terminology Criteria Adverse Event (NCI CTCAE) grade 2 or greater.
Nelarabine għandu jitwaqqaf ma 'l- ewwel sinjal ta' effetti newroloġiċi ta 'l- Eventi Avversi tal- Kriterji Komuni ta' Terminoloġija 'ta' l- Istitut Nazzjonali tal- Kanċer (NCI- CTCAE) grad 2 jew aktar.
Delaying subsequent dosing is an option for other toxicities, including haematological toxicity.
Fil- każ ta 'tossiċita' oħra, inkluża it- tossiċita fid- demm, tista 'tiġi kkunsidrata l- possibilita' li d- doża li jmiss tingħata aktar tard.
Insufficient numbers of patients aged 65 years of age and older have been treated with nelarabine to determine whether they respond differently than younger patients (see sections 4.4 and 5.2).
Ġew ikkurati numru insuffiċjenti ta 'pazjenti ta' 65 sena u fuqhom b' nelarabine biex jiġi deċiż jekk dawn il- pazjenti jirrejaġġixxux b' mod differenti minn pazjenti iżgħar (ara sezzjoni 4. 4 u 5. 2).
Renal Impairment
Indeboliment tal- kliewi
Nelarabine has not been studied in individuals with renal impairment.
Nelarabine ma ġiex studjat f' persuni b' indeboliment tal- kliewi.
Nelarabine and 9-β -D-arabinofuranosylguanine (ara-G) are partially renally excreted (see section 5.2 — Renal impairment).
Nelarabine u 9- β- D- arabinofuranosylguanine (ara- G) jitneħħew mil- ġisem parzjalment mill- kliewi (ara sezzjoni 5. 2
There are insufficient data to support a dose adjustment recommendation for patients with a renal clearance of creatinin Clcr less than 50 ml/ min.
aġġustament tad- doża f' pazjenti li jneħħu kreatinina CI cr ta 'anqas minn 50 ml/ min.
Patients with renal impairment must be closely monitored for toxicities when treated with nelarabine.
Meta jingħataw nelarabine pazjenti b' indeboliment tal- kliewi għandhom jiġu segwiti mill- qrib għal tossiċitajiet.
Hepatic Impairment
Indeboliment tal- fwied
Nelarabine has not been studied in patients with hepatic impairment.
Nelarabine ma ġiex studjat f' persuni b' indeboliment tal- fwied.
These patients should be treated with caution.
F' dawn il- pazjenti dan it- trattament għandu jingħata b' kawtela.
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għas- sustanzi attivi jew għal xi- sustanzi mhux attivi.
NEUROLOGICAL ADVERSE EVENTS Severe neurological events have been reported with the use of nelarabine.
EFFETTI AVVERSI NEWROLOĠIĊI Ġew irrappurtati effetti avversi newroloġiċi serji meta ntuża nelarabine.
These events have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis.
Dawn l- effetti inkludew bdil fl- istat mentali bħal ħedla severa ta 'nagħas, effetti fis- sistema nervuża ċentrali li jinkludu aċċessjonijiet, u newropatija periferali minn nuqqas ta' sensazzjoni u parasteżiji sa indeboliment
There have also been reports of events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré Syndrome.
Kien hemm ukoll rapporti ta 'każi assoċjati ma' demajlinazzjoni u newropatiji periferali axxendenti li jixbħu lis- Sindromu ta 'Guillain Barré.
Full recovery from these events has not always occurred with cessation of nelarabine.
Mhux dejjem kien hemm fejqan totali minn dawn il- każi meta twaqqaf nelarabine.
Therefore, close monitoring for neurological events is strongly recommended, and nelarabine must be discontinued at the first sign of neurological events of NCI CTCAE Grade 2 or greater.
Għalhekk hu rakkomandat b' mod qawwi li jkun hemm monitoraġġ mill qrib għal każi newroloġiċi u nelarabine għandu jitwaqqaf ma 'l- ewwel sinjal ta' effetti newroloġiċi ta 'NCI CTCAE grad 2 jew aktar.
3 Neurotoxicity is the dose-limiting toxicity of nelarabine.
In- newrotossiċita 'hija t- tossiċita li tillimita d- doża ta' nelarabine.
It is advised that patients undergoing therapy with nelarabine be closely observed for signs and symptoms of neurological toxicity.
Hu rrakkomandat li pazjenti li jkunu fuq trattament b' nelarabine jkunu osservati mill- qrib għal sinjali u sintomi ta 'tossiċita' newroloġika.
Common signs and symptoms of nelarabine-related neurotoxicity include somnolence, confusion, convulsions, ataxia, paraesthesias, and hypoesthesia.
Ħedla ta 'nagħas, konfużjoni, aċċessjonijiet, atassja, parasteżiji u nuqqas ta' sensazzjoni huma sinjali u sintomi komuni ta 'newrotossiċita' relatata ma 'nelarabine.
Severe neurological toxicity can manifest as coma, status epilepticus, demyelination, or ascending neuropathy similar in appearance to Guillain-Barré syndrome (see section 4.8).
Tossiċita 'newroloġika qawwija tista' timmanifesta ruħha bħala koma, status epilepticus, demajlinazzjoni jew newropatija axxendenti li tixbah fid- dehra lis- Sindromu ta 'Guillain Barré (ara sezzjoni 4. 8).
Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation are potentially at increased risk for neurological adverse events (see section 4.2
Pazjenti trattati qabel jew fl- istess ħin b' kemoterapija ġewwa t- teka jew minn qabel b' radjazzjoni kranjospinali huma potenzjalment f' riskju akbar għal effetti avversi newroloġiċi (ara sezzjoni 4. 2 - bidla fid- doża) u għalhekk m' humiex rakkomandati terapija ġewwa t- teka u/ jew radjazzjoni kranjospinali flimkien.
- dose modification) and therefore concomitant intrathecal therapy and/ or craniospinal irradiation is
Tilqim b' vaċċin ta 'organiżmu ħaj għandu l- potenzjal li jikkawża infezzjoni f' pazjenti bl- immunita' kompromessa.
Therefore, immunisations with live organism vaccines are not recommended.
Għalhekk mhuwiex rakkomandat tilqim b' vaċċin ta 'organiżmu ħaj.
Leukopenia, thrombocytopenia, anaemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy.
Lewkopenija, tromboċitopenija, anemija u newtropenja (li tinkludi newtropenja b' deni) ġew assoċjati ma 'trattament b' nelarabine.
Complete blood counts including platelets must be monitored regularly (see sections 4.2 and 4.8).
Għandu jiġi osservat regolarment l- għadd komplet taċ- ċelluli tad- demm inklużi l- plejtlets (ara sezzjonijiet 4. 2 u 4. 8).
Patients receiving nelarabine are recommended to receive intravenous hydration according to standard medical practice for the management of hyperuricemia in patients at risk of tumour lysis syndrome.
Hu rrakkomandat li pazjenti li jingħataw nelarabine għandhom jingħataw idratazzjoni minn ġol- vini skond il- prattika medika normali għall- maniġġjar ta 'iperuriċemija f' pazjenti b' riskju tas- sindrome ta' diżintegrazzjoni tat- tumur.
For patients at risk of hyperuricemia, the use of allopurinol should be considered.
L- użu ta 'allopurinol għandu jiġi kkunsidrat f' pazjenti b' riskju ta' iperuriċemija.
Clinical studies of nelarabine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Studji kliniċi b' nelarabine ma nkludewx numru suffiċċjenti ta 'pazjenti ta' u 'l fuq minn 65 sena biex ikun determinat jekk jirrispondux differenti minn pazjenti iżgħar.
In an exploratory analysis, increasing age, especially aged 65 years and older, appeared to be associated with increased rates of neurological adverse events.
F' analiżi esploratorja, żieda fl- eta 'speċjalment f' dawk ta' 65 sena jew akbar, dehret li kienet assoċjata ma 'rati akbar ta' efetti avversi newroloġiċi.
Carcinogenicity and mutagenicity
Karċinoġenita 'u mutaġeniċita'
Carcinogenicity testing of nelarabine has not been performed.
Ma sarux testijiet dwar il- karċinoġeniċita 'ta' nelarabine.
Nelarabine however, is known to be genotoxic to mammalian cells (see section 5.3).
Madankollu huwa magħruf li nelarabine huwa ġenotossiku għal ċelluli mammiferi (ara sezzjoni 5. 3).
Sodium warning
Twissija dwar sodju
This medicinal product contains 1.725 mg/ ml (75 mmol) of sodium.
Dan il- prodott mediċinali fih 1. 725 mg/ ml (75 mmol) ta 'sodju.
To be taken into consideration by patients on a controlled sodium diet.
Għandha tingħata konsiderazzjoni ta 'dan f' pazjenti fuq dieta kkontrollata ta' sodju.
Nelarabine and ara-G did not significantly inhibit the activities of the major hepatic cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in vitro.
Nelarabine u ara- G ma tellfux b' mod sinifikanti l- attivitajiet ta 'l- isoenżimi CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, jew CYP3A4 in vitro taċ- ċitokroma ewlenija tal- fwied, P450 (CYP).
4 4.6 Pregnancy and lactation
4 Mhuwiex rakkomandat l- użu ta 'nelarabine flimkien ma' inibituri ta 'adenosine deaminase bħal pentostatin.
There are no adequate data from the use of nelarabine in pregnant women.
Ma hemmx biżżejjed tagħrif dwar l- użu ta 'nelarabine f' nisa tqal.
Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Studji f’ annimali wrew tossiċita ’ fis- sistema riproduttiva li jinkludu malformazzjonijiet (ara s- sezzjoni 5. 3).
The potential risk in humans is unknown, however, exposure during pregnancy will likely lead to anomalies and malformations of the foetus.
Mhuwiex magħruf ir- riskju potenzjali fil- bnedmin; madankollu hemm ċans kbir li esponiment waqt it- tqala jwassal għal anomaliji u malformazzjonijiet tal- fetu.
Nelarabine should not be used during pregnancy unless clearly necessary.
Nelarabine m' għandux jintuża fit- tqala sakemm in- neċessita 'tiegħu ma tkunx tidher biċ- ċar.
If a patient becomes pregnant during treatment with nelarabine, they should be informed of the possible risk to the foetus.
Jekk pazjenta toħroġ tqila waqt trattament b' nelarabine, għandha tkun infurmata bil- ħsara li tista 'tiġri lil- fetu.
Both sexually active men and women should use effective methods of contraception during treatment and for at least three months following cessation of treatment.
Kemm nisa u rġiel li huma sesswalment attivi għandhom jużaw metodi ta 'kontraċezzjoni effettivi waqt it- trattament mill- inqas għal tlett xhur wara li jitwaqqaf it- trattament.
The effect of nelarabine on fertility in humans is unknown.
Mhux magħruf l- effett ta 'nelarabine fuq il- fertilita' tal- bnedmin.
Based on the pharmacological action of the compound, undesirable effects on fertility are possible.
Effetti mhux mixtieqa fuq il- fertilita 'huma possibbli fuq il- bażi ta' l- azzjoni farmakoloġika tal- prodott.
Family planning should be discussed with patients as appropriate.
L- ippjanar tal- familja għandu jiġi diskuss mal- pazjenti kif jixraq.
It is unknown whether nelarabine or its metabolites are excreted in human breast milk.
Mhux magħruf jekk nelarabine jew is- sustanzi ffurmati fil- metaboliżmu tiegħu jitneħħewx fil- ħalib tas- sider uman.
The excretion of nelarabine in milk has not been studied in animals.
It- tneħħija ta 'nelarabine fil- ħalib ma ġietx studjata f' annimali.
However, because of the potential for serious adverse reactions in infants, breastfeeding should be discontinued.
Madankollu it- treddigħ għandu jitwaqqaf minħabba l- potenzjal ta 'reazzjonijiet avversi serji fit- trabi.
Patients treated with nelarabine are potentially at risk of suffering from somnolence during and for several days after treatment.
Pazjenti ttrattati b' nelarabine huma fir- riskju li jsofru minn sonnolenza waqt u għal numru ta 'ġranet wara t- trattament.
Patients must be cautioned that somnolence can affect performance of skilled tasks, such as driving.
Il- pazjenti għandhom jiġu mwissija li s- sonnolenza tista 'taffetwa l- ħila f' ħidmiet li jeħtieġu s- sengħa' bħas- sewqan.
Clinical trial data
Data minn Studji Kliniċi
Pivotal clinical trial data
Data minn Studji Kliniċi Prinċipali
The safety profile from pivotal clinical trials at the recommended doses of nelarabine in adults (1,500 mg/ m2) and children (650 mg/ m2) is based on data from 103 adults and 84 paediatric patients respectively.
Il- profil ta 'sigurta' minn studji kliniċi prinċipali dwar- dożi ta 'nelarabine rakkommandati fl- adulti (1, 500 mg/ m2 u t- fal (650mg/ m2 huwa bbażat fuq data minn 103 pazjent adult u 84 pazjenti pedjatriċi rispettivament.
The most frequently occurring adverse events were fatigue; gastrointestinal disorders; haematological disorders; respiratory disorders; nervous system disorders; and pyrexia.
L- aktar effetti avversi li seħħew spiss kienu għejja, disturbi gastrointestinali, disturbi ematoloġiċi, disturbi respiratorji, disturbi tas- sistema nervuża u deni.
Neurotoxicity is the dose limiting toxicity associated with nelarabine therapy (see section 4.4).
In- newrotossiċita 'assoċjata ma' trattament b' nelarabine hija t- tossiċita 'li tillimita d- doża (ara sezzjoni 4. 4).
The following convention has been utilised for the classification of frequency:
Il- konvenzjoni li ġejja kienet utilizzata għall- klassifikazzjoni ta 'frekwenza:
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100), Rare (≥ 1/ 10,000 to < 1/ 1,000) and Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)
Komuni ħafna (≥1/ 10), Komuni (≥1/ 100 sa < 1/ 10), Mhux komuni (≥1/ 1, 000 sa 1/ 100), Rari (≥1/ 10, 000 sa < 1/ 1, 000) u Rari ħafna (< 1/ 10, 000), mhux magħrufa (ma jistgħux ikunu ikkalkulati mid- data disponibbli)
MedDRA Preferred Term(s) Infections and infestations
5 Terminu( i) Preferiti minn MedRA Infezzjonijiet u infestazzjonijiet
Adults (1,500 mg/ m2) N=103 (%)
Adulti (1, 500 mg/ m2) N=103 (%)
Children (650 mg/ m2) N=84 (%)
Tfal (650 mg/ m2) N=84 (%)
There was a single additional report of biopsy confirmed progressive multifocal leukoencephalopathy in the adult population.
Kien hemm rapport addizzjonali wieħed ta 'bijopsija li kkonfermat lewkoenċefalopatija progressiva f' aktar minn post wieħed fil- popolazzjoni adulta.
There have been reports of sometimes fatal opportunistic infections in patients receiving nelarabine therapy.
Kien hemm rapporti ta 'infezzjonijiet opportunistiċi xi kultant fatali f' pazjenti li kienu fuq trattament b' nelarabine.
Neoplasms benign and malignant (including cysts and polyps) Tumour lysis syndrome (see also Data from compassionate use programme and non-pivotal studies)
Neoplażmi beninni u malinni (li jinkludu ċesti u qarnit/ polipi) Sindromu ta 'diżintegrazzjoni tat- tumur (ara wkoll Data minn programm għal użu kompassjonali u studji mhux prinċipali)
Blood and lymphatic system disorders Febrile neutropenia Neutropenia Leukopenia Thrombocytopenia Anaemia
Disturbi fid- demm u fis- sistema limfatika Newtropenja bid- deni Newtropenja Lewkopenja Tromboċitopenja Anemija
12 (12) Very common:
12 (12) Komuni ħafna:
83(81) Common:
83 (81) Komuni:
3 (3) Very common:
3 (3) Komuni ħafna:
89 (86) Very common:
89 (86) Komuni ħafna:
1(1) Very common:
1 (1) Komuni ħafna:
79 (94) Very common:
79 (94) Komuni ħafna:
32 (38) Very common:
32 (38) Komuni ħafna:
74 (88) Very common:
74 (88) Komuni ħafna:
Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni Ipogliċemija Nuqqas ta 'kalċju fid- demm Nuqqas ta' manjesju fid- demm Ipokalimja Anoressija
N/ A Common:
N/ A Komuni:
3 (3) Common:
3 (3) Komuni:
4 (4) Common:
4 (4) Komuni:
5 (6) Common:
5 (6) Komuni:
7 (8) Common:
7 (8) Komuni:
5 (6) Very common:
5 (6) Komuni ħafna:
Psychiatric disorders Confusional state
Disturbi psikjatriċi
Nervous system disorders
Disturbi tas- sistema nervuża Aċċessjonijiet (li jinkludu konvulżjonijiet, konvulżjonijiet grand mal, status epilepticus)
Seizures (including convulsions, Common:
Komuni:
Amnesia Common:
Komuni:
3 (3) Somnolence Very common:
3 (3) Komuni ħafna:
24 (23) Peripheral neurological Very common:
24 (23) Komuni ħafna:
6 (7) Very common:
6 (7) Komuni ħafna:
6 MedDRA Preferred Term(s)
6 Terminu( i) Preferiti minn MedRA Disturbi newroloġiċi periferali (tas- sensi u motorji)
Ataxia Balance disorder Tremor Dizziness Headache Dysgeusia
Nuqqas ta 'sensazzjoni Paresteżija Atassja Disturbi tal- bilanċ Rogħda Sturdament Uġigħ ta` ras Disturbi fit- togħma
Common:
15 (15) Komuni:
9 (9) Common:
9 (9) Komuni:
2 (2) Common:
2 (2) Komuni:
5 (5) Very common:
5 (5) Komuni ħafna:
22 (21) Very common:
22 (21) Komuni ħafna:
15 (15) Common:
15 (15) Komuni:
2 (2) N/ A Common:
2 (2) N/ A Komuni:
3 (4) N/ A Very common:
3 (4) N/ A Komuni ħafna:
There have also been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Kien hemm ukoll rapporti ta 'effetti assoċjati ma' demajlinazzjoni u newropatiji periferali axxendenti li jixbhu fid- dehra lis- Sindromu ta 'Guillain Barré.
One subject in the paediatric group had a fatal neurological event of status epilepticus.
Suġġett mill- grupp pedjatriku kellu effett newroloġiku fatali ta 'status epilepticus
Eye disorders Blurred vision
Disturbi fl- għajnejn Vista mċajpra
Respiratory, thoracic, and mediastinal disorders Pleural effusion Wheezing Dyspnea Cough
Disturbi respiratorji, toraċiċi, u medjastinali Effużjoni fil- plewra Tħarħir Qtugħ ta 'nifs Sogħla
10 (10) Common:
10 (10) Komuni:
21 (20) Very common:
21 (20) Komuni ħafna:
Diarrhoea Stomatitis Vomiting Abdominal pain Constipation Nausea
Dijarea Infjammazzjoni tal- ħalq Rimettar Ugigħ ta 'żaqq Stitikezza Dardir
23 (22) Common:
23 (22) Komuni:
8 (8) Very common:
8 (8) Komuni ħafna:
9(9) Very common:
9 (9) Komuni ħafna:
1 (1) Common:
1 (1) Komuni:
8 (10) N/ A Common:
8 (10) N/ A Komuni:
Hepatobiliary disorders Hyperbilirubinaemia Transaminases increased Aspartate aminotransferase increased
Disturbi fil- fwied u fil- marrara Żieda fil- bilirubin Żieda fit- transaminases
8 (10) Very common:
8 (10) Komuni ħafna:
7 MedDRA Preferred Term(s)
7 Terminu( i) Preferiti minn MedRA Żieda fl- aspartate aminotransferase
Arthralgia Back pain Pain in extremity
Disturbi muskolu- skeltrali u tal- connective tissue Debbolizza fil- muskoli Uġigħ fil- muskoli Uġigħ fil- ġogi Ugigħ fid- dahar Uġigħ fl- idejn u s- saqajn
8 (8) Common:
8 (8) Komuni:
Common:
N/ A N/ A Komuni:
1 (1) N/ A Common:
1 (1) N/ A Komuni:
Blood creatinine increased
Disturbi fil- kliewi u fis- sistema urinarja Żieda tal- kreatinina fid- demm
General disorders and administrative site conditions Oedema Gait abnormal Oedema peripheral Pyrexia Pain Fatigue Asthenia
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Nefħa minn akkumulazzjoni ta 'ilma fil- ġisem
11 (11) Common:
11 (11)
6 (6) Very common:
6 (6) Komuni ħafna:
15 (15) Very common:
15 (15)
24 (23) Very common:
24 (23) Komuni ħafna:
11 (11) Very common:
11 (11) Komuni ħafna:
51 (50) Very common:
51 (50) Komuni ħafna:
N/ A N/ A N/ A Common:
Komuni:
Data from NCI studies/ compassionate use programme and phase I studies
Data minn studji ta 'l- NCI/ programm dwar l- użu kompassjonali u studji Fażi I
In addition to the adverse reactions seen in the pivotal clinical trials, there are also data from 875 patients from NCI studies/ compassionate use programme (694 patients) and Phase I (181 patients) studies of nelarabine.
Barra r- reazzjonijiet avversi li kien hemm fl- istudji kliniċi prinċipali, hemm ukoll data minn 875 pazjent minn studji ta 'l- NCI / programm dwar l- użu kompassjonali (694 pazjent) u dwar nelarabine Fażi I (181 pazjent).
The following additional adverse reactions were seen:
Kien hemm dawn ir- reazzjonijiet avversi oħra li ġejjin:
Neoplasms benign and malignant (including cysts and polyps)
Neoplażmi beninni u malinni (li jinkludu ċestijiet u qarnit/ polipi)
Tumour lysis syndrome – 7 cases (see sections 4.2 and 4.4)
Is- sindromu ta 'diżintegrazzjoni tat- tumur - 7 każijiet (ara sezzjonijiet 4. 2 u 4. 4)
No case of overdose has been reported.
Ma kien hemm l- ebda każ irrapurtat ta 'doża eċċessiva.
Nelarabine has been administered in clinical trials up to a dose of 75 mg/ kg (approximately 2,250 mg/ m2) daily for 5 days to a paediatric patient, up to a dose of 60 mg/ kg (approximately 2,400 mg/ m2) daily for 5 days to 5 adult patients and up to 2,900 mg/ m2 in a further 2 adults on days 1, 3 and 5.
Nelarabine ingħata fi studji kliniċi sa doża ta '75 mg/ kg (bejn wieħed u ieħor 2, 250 mg/ m2) kuljum għal ħamest ijiem lil pazjent pedjatriku wieħed, sa doża ta' 60 mg/ kg (bejn wieħed u ieħor 2, 400 mg/ m2 kuljum għal ħamest ijiem lil 5 pazjenti adulti u sa 2, 900 mg/ m2 lil 2 adulti oħra f' jiem 1, 3 u 5.
Symptoms and signs
8 Sintomi u sinjali
It is likely that nelarabine overdose would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression and potentially death.
Hemm probabbilta 'li doża eċċessiva b' nelarabine tirriżulta f' newrotossiċita' qawwija (li tinkludi possibilment paraliżi, koma) soppressjoni tal- mudullun u potenzjalment il- mewt.
At a dose of 2200 mg/ m2 given on days 1, 3 and 5 every 21 days, 2 patients developed a significant grade 3 ascending sensory neuropathy.
B' doża ta '2200 mg/ m2li ngħataw fi ġranet 1, 3 u 5 kull 21 ġurnata, 2 pazjenti żviluppaw newropatija tas- sensi axxendenti ta' grad 3.
MRI evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
Evalwazzjoni taż- 2 pazjenti b' MRI uriet sejbiet konsistenti ma 'proċess ta' demajelinizzazzjoni fl- ispina ċervikali.
8 There is no known antidote for nelarabine overdose.
Ma hemm l- ebda antidot magħruf għal doża eċċessiva ta 'nelarabine.
Supportive care consistent with good clinical practice should be provided.
Għandha tiġi pprovduta kura ta 'għajnuna konsistenti ma' prattika klinika tajba.