qanastek/EMEA-V3 huggingface dataset:
HOW TO USE ABILIFY
KIF GĦANDEK TUŻA ABILIFY
Your doctor will decide how much ABILIFY solution for injection you need and how long you need it for.
187 It- tabib tiegħek jiddeċiedi kemm għandek bżonn soluzzjoni għall- injezzjoni ABILIFY u għal kemm żmien għandek bżonnha.
The usual dose is 9.75 mg (1.3 ml) for the first injection.
Id- doża normali hija ta '9. 75 mg (1. 3 ml) għall- ewwel injezzjoni.
Up to three injections in 24 hours may be given.
Jistgħu jingħataw sa tlett injezzjonijiet f' 24 sigħa.
The total dose of ABILIFY (all formulations) should not exceed 30 mg per day.
Id- doża totali ta 'ABILIFY (il- formulazzjonijiet kollha) ma għandhiex taqbeż it- 30 mg kuljum.
182 ABILIFY solution for injection is ready to use.
Is- soluzzjoni għall- injezzjoni ABILIFY hija lesta għall- użu.
The correct amount of solution will be injected into your muscle by your doctor or nurse.
L- ammont tajjeb għas- soluzzjoni ikun injettat fil- muskolu tiegħek mit- tabib jew min- ners.
If you are concerned that you are given more ABILIFY solution for injection than you feel necessary, tell your doctor or nurse of your concern.
Jekk inti mħasseb li ingħatajt aktar soluzzjoni għall- injezzjoni ABILIFY milli inti tħoss li kellek bżonn, għid lit- tabib jew lin- ners dwar il- ħsieb tiegħek.
Only a few doses of ABILIFY solution for injection may be needed.
Jistgħu ikunu meħtieġa biss ftit dożi ta 'soluzzjoni għall- injezzjoni ABILIFY.
Your doctor will decide when you need another dose of ABILIFY solution for injection.
It- tabib tiegħek jiddeċiedi meta għandek bżonn doża oħra ta 'soluzzjoni għall- injezzjoni ABILIFY.
Common side effects (greater than 1 in 100, less than 1 in 10 patients) of ABILIFY solution for injection include sleepiness, dizziness, headache, restlessness, nausea and vomiting.
Effetti sekondarji komuni (aktar minn 1 f' kull 100, anqas minn 1 f' kull 10 pazjenti) ta 'soluzzjoni għall- injezzjoni ABILIFY jinkludu ngħas, sturdament, uġigħ ta' ras, irrikwetezza, dardir u remettar.
Uncommon side effects (greater than 1 in 1,000, less than 1 in 100 patients) Some people may have changes in blood pressure, may feel dizzy, especially when getting up from a lying or sitting position, or may experience a fast heart rate, dry mouth or fatigue.
Effetti sekondarji mhux komuni (iktar minn 1 minn kull 1, 000, inqas minn 1 minn kull 100 pazjent) Xi nies jista ’ jkollhom tibdil fil- pressjoni tad- demm, ħalq xott jew għejja.,
In addition, the following side effects have been seen in patients treated with oral formulations of ABILIFY:
Barra minn hekk, l- effetti sekondarji li ġejjin dehru f' pazjenti ttrattati b' formulazzjonijiet orali ta 'ABILIFY:
Common side effects (greater than 1 in 100, less than 1 in 10 patients) Uncontrollable twitching or jerking movements, headache, tiredness, nausea, vomiting, an uncomfortable feeling in the stomach, constipation, increased production of saliva, light-headedness, trouble sleeping, restlessness, feeling anxious, sleepiness, shaking and blurred vision.
Effetti sekondarji komuni (iktar minn 1 minn kull 100, inqas minn 1 minn kull 10 pazjenti) Movimenti bi skossi u b’ rogħda mingħajr kontroll, uġigħ ta ’ ras, għejja, dardir, remettar, fastidju fl - istonku, stitkezza, produzzjoni eċċessiva ta ’ bżieq, sturdament, diffikulta ’ biex torqod, nervożiżmu, ansjetà, għejja, tregħid, u vista mċajpra.
Uncommon side effects (greater than 1 in 1,000, less than 1 in 100 patients) Some people may feel dizzy, especially when getting up from a lying or sitting position, or may experience a fast heart rate.
Effetti sekondarji mhux komuni (iktar minn 1 minn kull 1, 000, inqas minn 1 minn kull 100 pazjent) Xi nies jistgħu iħossuhom storduti, speċjalment meta jqumu wara li jkunu mteddew jew qagħdu bilqiegħda, jew jistgħu iħossu qalbhom tħabbat tgħaġġel ħafna.
Other infrequently reported side effects:
Effetti sekondarji oħrajn irrapportati b’ mod inqas frekwenti:
Changes in the levels of some blood cells; unusual heart beat, sudden unexplained death, heart attack; allergic reaction (e. g. swelling in the mouth, tongue, face and throat, itching, rash); high blood sugar, onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, low sodium level in the blood; weight gain, weight loss, anorexia; nervousness, agitation, feeling anxious; thoughts of suicide, suicide attempt and suicide; speech disorder, seizure, combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate; fainting, high blood pressure, blockage of a blood vessel by a blood clot formed elsewhere in the body; spasm of the muscles around the voice box, accidental inhalation of food with risk of pneumonia, difficulty in swallowing; inflammation of the pancreas; inflammation of the liver, yellowing of the skin and white part of eyes, reports of abnormal liver test values, abdominal and stomach discomfort, diarrhoea; skin rash and sensitivity to light, unusual hair loss or thinning, excessive sweating; stiffness or cramps, muscle pain, weakness; involuntary loss of urine, difficulty in passing urine; prolonged and/ or painful erection; difficulty controlling core body temperature or overheating, chest pain, and swelling of hands, ankles or feet.
Tibdil fil- livelli ta 'xi ċelloli tad- demm; taħbit tal- qalb mhux normali, mewt għall- għarrieda bla spjegazzjoni, attakk tal- qalb; reazzjoni allerġika (eż. nefħa fil- ħalq, ilsien, wiċċ u gerżuma, ħakk, raxx); livell għoli ta' zokkor fid- demm, bidu jew aggravar tad- dijabete, ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma, livell baxx ta 'sodju fid- demm; żjieda fil- piż, telf fil- piż, anoreksja; nervożiżmu, aġitazzjoni; tħossok ansjuż/ a; ħsibijiet ta' suwiċidju, tentattiv ta ’ suwiċidju, suwiċidju; disturbi fid - diskors, attakk tal- qalb, kombinazzjoni ta ’ deni, ebusija tal- muskoli, teħid tan- nifs aktar mgħaġġel, ħruġ ta ’ għaraq, nuqqas ta ’ konoxxenza u tibdil f’ daqqa fil- pressjoni tad- demm u fir- rata tat- tħabbit tal- qalb; ħass ħażin; pressjoni għolja; imblokk ta ’ vina jew arterja b’ embolu li fforma xi mkien ieħor fil- ġisem; spażmi tal- muskoli madwar il- kaxxa vokali, bligħ aċċidentali ta 'ikel b' riskju ta' pnewmonja, diffikultà biex tibla '; infjammazzjoni tal- pankreas, produzzjoni akbar ta' bżieq; infjammazzjoni tal - fwied, sfurija tal- ġilda u tal- parti bajda ta 'l- għajnejn, rapporti ta' valuri anormali ta 'testijiet tal- fwied; diqa addominali u fl- istonku, dijarea; raxx tal- ġilda u sensittività għad- dawl, telf jew tħaffif mhux normali tax- xagħar, togħroq iżżejjed; ebusija jew bugħawwiġ, uġigħ fil- muskoli, dgħjufija; telf involontarju ta' awrina, diffikultà fil- mogħdija ta 'l- awrina; erezzjoni prolongata u/ jew bl- uġigħ; diffikultà fil- kontroll tat- temperatura tal- ġisem jew sħana eċċessiva, uġigħ fis- sider u nefħa ta ’ l- idejn, l- għekiesi jew is- saqajn.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole.
188 F' pazjenti anzjani b' dimensja, ġew irrapportati każijiet aktar fatali mat- teħid ta 'aripiprazole.
Do not use ABILIFY after the expiry date which is stated on the carton and on the vial.
Tużax ABILIFY wara d- data ta 'skadenza li tidher fuq il- kartuna u fuq il- kunjett.
Each ml contains 7.5 mg aripiprazole.
Kull ml fih 7. 5 mg ta 'aripiprazole.
The other ingredients are sulfobutylether β -cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection.
Kunjett fih 9. 75 mg ta 'aripiprazole. huma sulfobutylether β- cyclodextrin (SBECD), tartaric acid, sodium hydroxide, u ilma għall - injezzjoni.
What ABILIFY looks like and contents of the pack The ABILIFY solution for injection is a clear, colourless, aqueous solution.
Id- Dehra ta 'ABILIFY u l- kontenuti tal- pakkett Is- soluzzjoni għall- injezzjoni ABILIFY hija soluzzjoni fl- ilma ċara, bla kulur.
Each carton contains one single-use type I glass vial with a rubber butyl stopper and a "flip-off" aluminium seal.
Kull kartuna għandha kunjett tal- ħġieġ tat- tip I għal użu ta 'darba f' tapp tal- gomma tal- butyl u siġill ta' l- aluminju tat- tip "flip- off".
This leaflet was last approved in
190 Dan il- fuljett kien approvat l- aħħar f '
What is Abraxane?
X’ inhu Abraxane?
Abraxane is a powder that is made up into a suspension for infusion (drip into a vein).
Abraxane hu trab li jintuża biex jifforma sospensjoni għall- infużjoni (dripp fil- vina).
It contains the active substance paclitaxel (5 mg/ ml).
Fih is- sustanza attiva paclitaxel (5 mg/ ml).
What is Abraxane used for?
Għal xiex jintuża Abraxane?
Abraxane is used to treat metastatic breast cancer in patients whose first treatment for their metastatic disease has stopped working and for whom standard treatment including an ‘ anthracycline’ (a type of anticancer medicine) is not suitable. ‘ Metastatic’ means that the cancer has spread to other parts of the body.
Abraxane jintuża għat- trattament ta ’ kanċer metastatiku tas- sider f’ pazjenti li l- ewwel trattament għall - marda metastatika tagħhom ma jkunx ħadem u li ma jkunux jistgħu jingħataw trattament standard inkluża l - ‘ antraċiklina ’ (antraċiklina - tip ta ’ mediċina ta ’ kontra l- kanċer). ‘ Metastatiku ’ tfisser li l - kanċer ikun infirex għal partijiet oħra tal- ġisem.
Abraxane is used on its own.
Abraxane jintuża waħdu.
How is Abraxane used?
Kif jintuża Abraxane?
Abraxane should only be given under the supervision of a specialist cancer doctor in wards that are specialised in giving ‘ cytotoxic’ (cell-killing) medicines.
Abraxane għandu jingħata taħt is- superviżjoni ta ’ onkologu (tabib speċjalizzat fil- kanċer) fi swali speċjalizzati fil- għoti ta ’ mediċini ‘ ċitotossiċi ’ (li joqtlu ċ- ċelloli).
The recommended dose is 260 mg per square metre of body surface area (calculated using the patient ’ s height and weight).
Id- doża rakkomandata hi ta ’ 260 mg għal kull metru kwadru ta ’ l- erja tas- superfiċje tal- ġisem (ikkalkolata mit- tul u l- piż tal- pazjent).
It is given over a period of 30 minutes, every three weeks.
Jingħata fuq perjodu ta ’ 30 minuta, kull tliet ġimgħat.
The dose may be reduced or treatment interrupted in patients who have certain side effects affecting the blood or the nerves.
F’ pazjenti li jkollhom ċerti effetti sekondarji li jaffettwaw id- demm jew in- nervituri, id- doża tista ’ titnaqqas jew jista ’ jitwaqqaf it- trattament.
Abraxane should not be used in patients who have severe problems with their liver.
Abraxane m’ għandux jingħata lil pazjenti li jkollhom problemi gravi fil- fwied.
The appropriate doses for patients with mild or moderate liver problems or with kidney problems are not known.
Id- dożi xierqa għal pazjenti bi problemi ħfief jew moderati fil- fwied jew bi problemi fil- kliewi mhumiex magħrufa.
How does Abraxane work?
Kif jaħdem Abraxane?
The active substance in Abraxane, paclitaxel, belongs to the group of anticancer medicines known as the ‘ taxanes’.
Is- sustanza attiva f’ Abraxane, paclitaxel, tagħmel parti mill- grupp ta ’ mediċina ta ’ kontra l- kanċer magħrufa bħala ‘ taxanes ’.
Paclitaxel blocks the ability of cancer cells to break down their internal ‘ skeleton ’ that allows them to divide and multiply.
Paclitaxel jimblokka l- kapaċità taċ- ċelloli tal- kanċer li jkissru l - ‘ iskeletru ’ intern tagħhom li jippermettilhom jinqasmu u jitkattru.
With their skeleton still in place, the cells cannot divide and they eventually die.
Meta l- iskeletru ma jkunx għadu f’ postu, iċ - ċelloli ma jkunux jistgħu jinqasmu u eventwalment imutu.
Abraxane also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Abraxane jaffettwa wkoll iċ- ċelloli mhux tal- kanċer bħad- demm u ċ- ċelloli tan- nervituri, u dan jista ’ jikkawża xi effetti sekondarji.
Paclitaxel has been available as an anticancer medicine since 1993.
Paclitaxel ilu disponibbli bħala mediċina ta ’ kontra l- kanċer sa mill- 1993.
Conventional types of paclitaxel contain substances (solvents) that dissolve the paclitaxel, but can cause side effects.
It- tipi konvenzjonali ta ’ paclitaxel ikun fihom sustanzi (solventi) li jiddissolvu l- paclitaxel, iżda jistgħu jikkawżaw xi effetti sekondarji.
Abraxane does not contain these solvents.
Abraxane ma fihx dawn is- solventi.
Instead, the paclitaxel is attached to a human protein called albumin in tiny particles known as ‘ nanoparticles’.
Minflok paclitaxel jeħel ma ’ proteina umana magħrufa bħala albumina f’ partiċelli żgħar magħrufa bħala ‘ nanopartiċelli ’.
This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Dan jagħmilha faċli biex titħejja sospensjoni ta ’ paclitaxel, li tkun tista ’ tingħata f’ vina.
The nanoparticles may also affect the way the medicine is distributed within the
In- nanopartiċelli jistgħu jaffettwaw ukoll il - mod ta ’ kif il- mediċina tiġi distribwita fil- ġisem, u għalhekk il- benefiċċji u r- riskji tagħha, meta mqabbla ma ’ mediċini konvenzjonali li jkun fihom paclitaxel.
(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 body, and therefore its benefits and risks, in comparison with conventional medicines containing paclitaxel.
(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 Kif ġie studjat Abraxane?
The effects of Abraxane were first tested in experimental models before being studied in humans.
L- effetti ta ’ Abraxane għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil - bnedmin.
The company also presented data from the published literature.
Il- kumpanija ppreżentat ukoll dejta mil- letteratura xjentifika ppubblikata.
The effectiveness of Abraxane has been studied in one main study involving 460 women with metastatic breast cancer, around three-quarters of whom had received an anthracycline in the past.
L- effikaċja ta ’ Abraxane ġiet studjata fi studju wieħed ewlieni li fih ħadu sehem 460 mara b’ kanċer metastatiku fis- sider, li madwar tliet kwarti minnhom kienu ngħataw antraċiklina fl- imgħoddi.
Around half of the patients in the study had already received treatments for their cancer after it had become metastatic.
Madwar nofs il- pazjenti li ħadu sehem fl- istudju diġà kienu ngħataw trattament għal kontra l- kanċer wara li kien sar metastatiku.
The effects of Abraxane (given on its own) were compared with those of a conventional paclitaxel- containing medicine (given together with other medicines to reduce side effects).
L- effetti ta ’ Abraxane (mogħti waħdu) tqabblu ma ’ dawk ta ’ mediċina li fiha il- paclitaxel konvenzjonali (mogħtija flimkien ma ’ mediċini oħra biex inaqqsu l- effetti sekondarji).
The main measure of effectiveness was the number of patients who ‘ responded ’ after at least five weeks of treatment.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien in- numru ta ’ pazjenti li ‘ rrispondew ’ wara trattament ta ’ mill- inqas ħames ġimgħat.
This was defined as the patient’ s main tumours having disappeared or having shrunk in size by at least 30%.
Dan kien definit bħala li t- tumuri ewlenin tal- pazjent jisparixxu jew jonqsu fid- daqs b’ ta ’ l - inqas 30%.
What benefit has Abraxane shown during the studies?
X’ inhu l- benefiċċju ta ’ Abraxane li ntwera f’ dawn l- istudji?
Abraxane was more effective than conventional paclitaxel-containing medicines.
Abraxane kien iktar effikaċi minn mediċini konvenzjonali li fihom paclitaxel.
Overall, in the main study, 72 (31%) of the 229 women receiving Abraxane responded to treatment, compared with 37 (16%) of the 225 receiving conventional paclitaxel-containing medicines.
Globalment, fl- istudju ewlieni, 72 (31%) mill- 229 mara li kienu qed jingħataw Abraxane rrispondew għat- trattament, meta mqabbla ma ’ 37 (16%) mill- 225 li kienu qed jieħdu mediċini konvenzjonali bil- mediċini li fihom paclitaxel.
When looking only at the patients who were receiving their first treatment for metastatic breast cancer, there was no difference between the medicines in terms of measures of effectiveness such as the time until the disease got worse and survival.
Meta wieħed iħares biss lejn il- pazjenti li jkunu ngħataw l- ewwel trattament tagħhom għall- kanċer metastatiku tas- sider, ma kienx hemm differenza bejn il- mediċini f’ termini ta ’ mezzi tal- kejl ta ’ l - effikaċja bħall- ħin sakemm il- marda qalbet għall- agħar u s- sopravivenza.
In contrast, in patients who had taken other treatments for metastatic breast cancer before, these additional measures showed that Abraxane was more effective than conventional paclitaxel-containing medicines.
B’ kuntrast, fil- pazjenti li kienu ħadu iktar trattamenti għall- kanċer metastatiku tas- sider minn qabel, dawn il- miżuri addizzjonali wrew li Abraxane kien iktar effikaċi minn mediċini konvenzjonali b’ paclitaxel.
Therefore, the company withdrew its application for the use of Abraxane as first-line treatment during the assessment of the medicine.
Għalhekk il - kumpanija rtirat l- applikazzjoni tagħha għall- użu ta ’ Abraxane bħala l- ewwel linja ta ’ trattament waqt il- valutazzjoni tal- mediċina.
What is the risk associated with Abraxane?
X’ inhu r- riskju assoċjat ma ’ Abraxane?
The most common side effects with Abraxane (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), leucopenia (low levels of leucocytes, a type of white blood cell), thrombocytopenia (low blood platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), peripheral neuropathy (nerve damage in the hands and feet), neuropathy (nerve damage), hypoaesthesia (reduced sense of touch), paraesthesia (unusual sensations like pins and needles), nausea (feeling sick), diarrhoea, vomiting, constipation, stomatitis (inflammation of the lining of the mouth), alopecia (hair loss), rash, arthralgia (joint pain), myalgia (muscle pain), anorexia (loss of appetite), fatigue (tiredness), asthenia (weakness) and pyrexia (fever).
L- iktar effetti sekondarji komuni ma ’ Abraxane (li dehru f’ iktar minn pazjenti wieħed minn kull 10) huma n- newtropenija, (livelli baxxi ta ’ newtrofili, tip ta ’ ċelloli tad- demm bojod), l- anemija (għadd baxx ta ’ ċelloli tad- demm ħomor), lewkopenija (livelli baxxi ta ’ lewkoċiti, tip ta ’ ċelloli tad- demm bojod, tromboċitopenija (livelli baxxi ta ’ platelets fid- demm), limfopenija (livelli baxxi ta ’ limfoċiti, tip ta ’ ċelloli td- demm bojod), newropatija periferika (ħsara fin- nervituri fl- idejn u s- saqajn), newropatija (ħsara fin- nervituri), ipoestesija (tnaqqis fis- sens tal- mess), paraestesija (sensazzjonijiet mhux tas- soltu bħal tnemnim, nawsea (dardir), dijarea, remettar, kostipazzjoni, stomatite (infjammazzjoni tal- kisi tal- ħalq), alopeċja (twaqqigħ ta ’ xagħar u suf), raxx, artralġija (uġigħ fil- ġogi) mijalġija (uġigħ fil- muskoli), anoressija (nuqqas ta ’ aptit), għeja kbira, astenija (dgħjufija) u piressija (deni).
For the full list of all side effects reported with Abraxane, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati ma ’ Abraxane, ara l- Fuljett ta ’ Tagħrif.
Abraxane should not be used in people who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients.
Abraxane m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal paclitaxel jew għal kwalunkwe sustanza oħra tiegħu.
It should also not be used in patients who are breast feeding or who have low levels of neutrophils in the blood before starting treatment.
M’ għandux jintuża f’ pazjenti li jkunu qed ireddgħu jew li jkollhom livelli baxxi ta ’ newtrofili fid- demm qabel ma jibdew it- trattament.
Why has Abraxane been approved?
Għaliex ġie approvat Abraxane?
The Committee for Medicinal Products for Human Use (CHMP) noted that Abraxane was more effective than conventional paclitaxel-containing medicines in patients whose first treatment had stopped working, and that, unlike other paclitaxel-containing medicines, it does not need other medicines to reduce side effects.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) innota li Abraxane kien iktar effikaċi minn mediċini konvenzjonali li fihom paclitaxel f’ pazjenti li l- ewwel trattament tagħhom ma jkunx ħadem fuqhom u li, għall- kuntrarju ta ’ mediċini oħra li fihom paclitaxel, ma jkollux bżonn ta ’ mediċini oħra għat- tnaqqis ta ’ l- effetti sekondarji.
The Committee decided that Abraxane’ s benefits are greater than its risks for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Abraxane huma ikbar mir- riskji tiegħu meta użat għat- trattament tal- kanċer metastatiku tas- sider f’ pazjenti li jkun fallielhom it- trattament ta ’ l- ewwel linja għall- mard metastatiku u li għalihom ma tkunx indikata t- terapija standard li jkun fiha antraċiklina.
The Committee recommended that Abraxane be given marketing authorisation.
Il- Kumitat irrakkomanda li Abraxane jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Abraxane:
Tagħrif ieħor dwar Abraxane:
The European Commission granted a marketing authorisation valid throughout the European Union for Abraxane to Abraxis BioScience Limited on 11 January 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Abraxane lil Abraxis BioScience Limited fi 11 ta ’ Jannar 2008.
The full EPAR for Abraxane can be found here.
L- EPAR sħiħ għal Abraxane jista ’ jinstab minn hawnhekk.
EU/ 1/ 07/ 428/ 001
Numru ta ’ l- EU EU/ 1/ 07/ 428/ 001
Abraxane
Isem inventat Abraxane
5 mg/ ml
Qawwa 5 mg/ ml
Powder for suspension for infusion
Għamla farmaċewtika Trab għal suspensjoni għall - infużjoni
Intravenous use
Mnejn jingħata Użu għal fil- vini
vial (glass)
Il- pakkett Vjala (tal - ħġieġ)
100 mg
Kontenut 100 mg
1 vial
Daqs tal- pakkett 1 vjala
ANNEX 1
ANNESS 1
Abraxane 5 mg/ ml powder for suspension for infusion.
Abraxane 5 mg/ ml trab għal suspensjoni għall- infużjoni.
Each vial contains 100 mg of paclitaxel.
Kull vjala fiha 100 mg ta ’ paclitaxel.
After reconstitution, each ml of suspension contains 5 mg of paclitaxel.
Wara r- rikostituzzjoni, kull ml ta ’ suspensjoni jkun fih 5 mg ta ’ paclitaxel.
Excipients The reconstituted medicinal product contains approximately 425 mg sodium per dose.
Sustanzi mhux attivi Il- prodott mediċinali rrikostitwit fih madwar 425 mg ta ’ sodium f’ kull doża.
Powder for suspension for infusion.
Trab għal suspensjoni għall- infużjoni.
The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/ kg.
Is- suspensjoni rrikostitwita għandha pH ta ’ 6- 7. 5 u osmolalità ta ’ 300- 360 mOsm/ kg.
The powder is white to yellow.
It- trab huwa bejn abjad u isfar
Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (See also section 4.4).
Bħala mediċina weħidha, Abraxane hu indikat għall- kura ta ’ kanċer metastatiku tas- sider f’ pazjenti fejn il- kura inizjali tkun falliet u li għalihom it- terapija standard li jkun fiha anthracycline ma tkunx indikata (Ara wkoll sezzjoni 4. 4).
Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Abraxane għandu jingħata biss taħt is- superviżjoni ta ’ onkoloġista kkwalifikat, f’ ċentri speċjalizzati fl - għoti ta ’ sustanzi ċitotossiċi.
The procedure for reconstitution is described in section 6.6.
Il- proċedura għar- rikostituzzjoni hi deskritta f’ sezzjoni 6. 6.
The recommended dose of Abraxane is 260 mg/ m2 administered intravenously over 30 minutes every 3 weeks.
Id- doża rrakkomandata ta ’ Abraxane hi ta ’ 260 mg/ m2 li tingħata fil- vina tul perijodu ta ’ 30 minuta kull 3 ġimgħat.
Dose adjustments during treatment:
Aġġustamenti fid- doża matul il- kura:
Patients who experience severe neutropenia (neutrophil count < 0.50 x 109/ l for a week or longer) or severe sensory neuropathy during Abraxane therapy should have the dose reduced to 220 mg/ m2 for subsequent courses.
Pazjenti li jkollhom newtropenja severa (għadd tan- newtrofili ta ’ < 0. 50 x 109/ l għal ġimgħa jew aktar) jew newropatija sensorja severa waqt it- terapija b’ Abraxane, għandu jkollhom id- doża mnaqqsa għal 220 mg/ m2 għal korsijiet sussegwenti.
Following recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/ m2.
Wara r- rikorrenza ta ’ newtropenja severa jew newropatija severa tas- sensi, għandu jsir tnaqqis aktar fid- doża għal 180 mg/ m2.
Abraxane should not be administered until neutrophil counts recover to > 1.5 x 109/ l.
Abraxane m’ għandux jingħata sakemm l- għadd tan- newtrofili jirkupra għal > 1. 5 x 109/ l.
For grade 3 sensory neuropathy withhold treatment until resolution to grade 1 or 2, followed by a dose reduction for all subsequent courses.
Għal newropatija sensorja ta ’ grad 3, waqqaf il- kura sakemm il- marda ssir ta ’ grad 1 jew 2, imbagħad naqqas id- doża għal korsijiet sussegwenti kollha.
2 Patients with hepatic impairment:
Pazjenti b’ indeboliment tal- fwied:
Insufficient data are currently available to recommend dose modifications in patients with mild to moderate hepatic impairment (see sections 4.4. and 5.2).
2 Bħalissa hemm dejta insuffiċjenti biex tirrakkomanda modifikazzjonijiet fid- dozaġġ f’ pazjenti li jkollhom indeboliment tal- fwied minn ħafif sa moderat (ara sezzjonijiet 4. 4 u 5. 2).
Patients with severe hepatic impairment should not be treated with paclitaxel.
Pazjenti b’ indeboliment sever tal- fwied m’ għandhomx ikunu kkurati b’ paclitaxel.
Patients with impaired renal function:
Pazjenti b’ indeboliment fil- funzjoni tal- kliewi:
Studies in patients with impaired renal function have not been performed and insufficient data are currently available to recommend dose modifications in patients with renal impairment (see section 5.2).
Ma sarux studji f’ pazjenti b’ indeboliment fil- funzjoni tal- kliewi u bħalissa hemm dejta insuffiċjenti biex isiru rakkomandazzjonijiet dwar modifikazzjonijiet fid- doża f’ pazjenti b’ impediment tal- kliewi (ara sezzjoni 5. 2).
Abraxane is not recommended for use in children below age 18 years due to insufficient data on safety and efficacy.
Abraxane mhuwiex irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena minħabba li m’ hemmx tagħrif biżżejjed dwar is- sigurtà u l- effikaċja.
In the clinical studies, no toxicities occurred notably more frequently among elderly patients who received Abraxane.
Fi studji kliniċi, ma seħħew l- ebda tossiċitajiet partikolarment spissi fost pazjenti anzjani li ngħataw Abraxane.
Lactation.
Treddigħ.
Patients who have baseline neutrophil counts < 1.5 x 109/ l.
Pazjenti li jkollhom għadd tan- newtrofili fil- linja bażi ta ’ < 1. 5 x 109/ l.
Abraxane is an albumin-bound nanoparticle formulation of paclitaxel, which may have substantially different pharmacological properties compared to other formulations of paclitaxel (see sections 5.1 and 5.2)..
Abraxane hu formulazzjoni ta ’ nanopartikuli ta ’ paclitaxel li jeħlu ma ’ l- albumina li jista ’ jkollhom kwalitajiet farmakoloġiċi li huma differenti b’ mod sostanzjali meta mqabbla ma ’ formulazzjonijiet oħrajn ta ’ paclitaxel (ara sezzjonijiet 5. 1 u 5. 2).
If hypersensitivity occurs, the medicinal product should be discontinued immediately, symptomatic treatment should be initiated, and that patient should not be rechallenged with paclitaxel.
Jekk ikun hemm sensittività eċċessiva, il- prodott mediċinali għandu jitwaqqaf immedjatament, kura sintomatika għandha tinbeda, u l- pazjent m’ għandux jerġa ’ jingħata paclitaxel.
Bone marrow suppression (primarily neutropenia) occurs frequently with Abraxane.
Trażżin tal- mudullun (primarjament newtropenja) iseħħ b’ mod frekwenti b’ Abraxene.
Neutropenia is dose-dependent and a dose-limiting toxicity.
In- newtropenja tiddependi mid- doża u tossiċità li tillimita d- doża.
Frequent monitoring of blood cell counts should be performed during Abraxane therapy.
Monitoraġġ frekwenti ta ’ l- għadd taċ- ċelluli tad - demm għandu jitwettaq matul it- terapija b’ Abraxane.
Patients should not be retreated with subsequent cycles of Abraxane until neutrophils recover to > 1.5 x 109/ l and platelets recover to > 100 x 109/ l.
Il- pazjenti m’ għandhomx ikunu kkurati mill - ġdid b’ ċikli oħra ta ’ Abraxane sakemm in- newtrofili jirkupraw għal > 1. 5 x 109/ l u l- plejtlits jirkupraw għal > 100 x 109/ l.
Neuropathy:
Newropatija:
Sensory neuropathy occurs frequently with Abraxane, although development of severe symptoms is less common.
Newropatija tas- sensi sseħħ b’ mod frekwenti b’ Abraxane, għalkemm l- iżvilupp ta ’ sintomi severi hu inqas komuni.
The occurrence of grade 1 or 2 sensory neuropathy does not generally require dose reduction.
L- okkorrenza ta ’ newropatija sensorja ta ’ grad 1 jew 2, ġeneralment ma tkunx teħtieġ tnaqqis fid- doża.
If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of Abraxane is recommended (see section 4.2).
Jekk tiżviluppa newropatija sensorja ta ’ grad 3, hu rrakkomandat li l- kura għandha titwaqqaf sakemm il- marda ssir ta ’ grad 1 jew 2, segwita minn tnaqqis fid- doża għal korsijiet oħra kollha ta ’ Abraxane (ara sezzjoni 4. 2).
3 Hepatic Impairment:
3 Pazjenti b’ indeboliment tal- fwied jistgħu jkunu f’ riskju akbar ta ’ tossiċità, partikularment minħabba majelosoppressjoni, u dawn il- pazjenti għandhom ikunu mmonitorjati għall- iżvilupp ta ’ majelosoppressjoni profonda.
The use of Abraxane has not been formally studied in patients specifically with hepatic impairment.
L- użu ta ’ Abraxane ma kienx studjat formalment f’ pazjenti speċifikament b’ indeboliment tal- fwied.
Patients with severe hepatic impairment (bilirubin > 5 x ULN or ASL/ ALT > 10 x ULN) should not be treated with Abraxane.
Pazjenti b’ indeboliment sever tal- fwied (bilirubina > 5 x ULN jew ASL/ ALT > 10 x ULN) m’ għandhomx ikunu kkurati b’ Abraxane.
The appropriate dose regimen in patients with less severe hepatic impairment is unknown.
Il- kors adattat tad- doża f’ pazjenti b’ indeboliment tal- fwied inqas sever mhuwiex magħruf.
While cardiotoxicity unequivocally related to Abraxane has not been demonstrated, cardiac events are not uncommon in the indicated population, especially in patients who have previously received anthracyclines or have underlying cardiac or pulmonary disease.
Filwaqt li ma ntweriex b’ mod mhux ċar li l- kardjotossiċità kienet marbuta ma ’ Abraxane, l - avvenimenti kardijaċi huma komuni fil- popolazzjoni studjata, speċjalment f’ pazjenti li qabel kienu rċivew anthracyclines jew li jkollhom mard bażiku kardijaku jew pulmonari.
Thus patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events.
Għaldaqstant, il- pazjenti li jkunu qed jirċievu Abraxane, għandhom ikunu mmonitorjati bl- attenzjoni għal xi avvenimenti kardijaċi.
Sexually active men and women should use effective methods of contraception during treatment and up to six months after treatment for men, and one month after treatment for women (see section 4.6).
Irġiel u nisa li huma attivi sesswalment għandhom jużaw metodi effettivi ta ’ kontraċezzjoni matul il - kura, u sa sitt xhur wara l- kura għall- irġiel, u sa xahar wara l- kura għan- nisa (ara sezzjoni 4. 6).
The effectiveness and safety of Abraxane in patients with central nervous system (CNS) metastases has not been established.
L- effettività u s- sigurtà ta ’ Abraxane f’ pazjenti b’ metastasi fis- sistema nervuża ċentrali (CNS) ma kinux stabbiliti.
CNS metastases are generally not well controlled by systemic chemotherapy.
Il- metastasijiet tas- CNS mhumiex ġeneralment ikkontrollati tajjeb bil- kimoterapija sistemika.
Gastrointestinal Symptoms:
Sintomi Gastrointestinali:
If patients experience nausea, vomiting and diarrhoea following the administration of Abraxane, they may be treated with commonly used anti-emetics and constipating agents.
Jekk il- pazjenti jkollhom dardir, rimettar u dijarea wara l- għoti ta ’ Abraxane, jistgħu jkunu kkurati b’ anti- emetiċi jew sustanzi konstipanti li s- soltu wieħed juża Sustanzi mhux attivi
When reconstituted, Abraxane contains approximately 425 mg sodium per dose.
Meta rrikostitwit, Abraxane fih madwar 425 mg ta ’ sodium f’ kull doża.
To be taken into consideration by patients on a controlled sodium diet.
Wieħed għandu jagħti kas dan l- ammont f’ pazjenti li qegħdin fuq dieta kkontrollata tas- sodium.
4.5 Interactions with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Il- metaboliżmu ta ’ paclitaxel hu kkatalizzat, parzjalment, mill- isoenżimi CYP2C8 u CYP3A4 ta ’ ċitokrom P450 (ara sezzjoni 5. 2).
Therefore, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit (e. g. erythromycin, fluoxetine, imidazole antifungals) or induce (e. g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) either CYP2C8 or CYP3A4.
Għalhekk, għandha tingħata attenzjoni meta tagħti paclitaxel fl - istess ħin ma ’ mediċini li huma magħrufa li jinibixxu (eż. erythromycin, fluoxetine, antifungals ta ’ imidazole) jew li jinduċu (eż. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) CYP2C8 jew CYP3A4.
Abraxane is indicated for mono-therapy.
Abraxane hu indikat għal monoterapija.
Abraxane should not be used in combination with other anticancer agents.
Abraxane m’ għandux jintuża flimkien ma ’ sustanzi oħra ta ’ kontra l- kanċer.
There are very limited data on the use of paclitaxel in human pregnancy.
Hemm informazzjoni limitata ħafna dwar l- użu ta ’ paclitaxel waqt it- tqala fil- bniedem.
Paclitaxel is suspected to cause serious birth defects when administered during pregnancy.
Paclitaxel hu ssuspettat li jikkawża difetti serji tal- wild meta jingħata waqt it- tqala.
Abraxane should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
Abraxane m’ għandux jintuża waqt it- tqala u f’ nisa li jista ’ jkollhom it- tfal u li ma jkunux qed jużaw kontraċezzjoni effettiva, ħlief jekk il- kundizzjoni klinika ta ’ l- omm tkun teħtieġ il- kura b’ paclitaxel.
4 Women of childbearing potential should use effective contraception during and up to 1 month after receiving treatment with Abraxane.
4 Nisa li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni effettiva matul u sa xahar wara li jirċievu l- kura b’ Abraxane.
Male patients treated with Abraxane are advised not to father a child during and up to six months after treatment.
Pazjenti rġiel kkurati b’ Abraxane huma mwissija biex ma jnisslux tfal waqt u sa sitt xhur wara li tispiċċa l- kura.
It is not known if paclitaxel is excreted in human milk.
Mhux magħruf jekk paclitaxel jitneħħiex fil- ħalib tal- bniedem.
Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation.
Minħabba li jista ’ jkun hemm reazzjonijiet avversi serji fit- trabi li jkunu qed jerdgħu, Abraxane hu kontra- indikat matul it- treddigħ.
Breastfeeding must be discontinued for the duration of therapy.
It- treddigħ għandu jitwaqqaf matul il- kura.
Abraxane induced infertility in male rats (see section 5.3).
Abraxane jikkaġuna infertilità fi ġrieden irġiel (ara sezzjoni 5. 3).
Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Il- pazjenti rġiel għandhom jieħdu parir dwar il- ħażna ta ’ l- isperma qabel il- kura minħabba l- possibbiltà ta ’ infertilità irriversibbli minħabba t- terapija b’ Abraxane.
Abraxane has minor or moderate influence on the ability to drive and use machines.
Abraxane għandu effett minuri jew moderat fuq il- ħila biex issuq u tħaddem il- magni.
Patients should be advised not to drive and use machines if they feel tired or dizzy.
Abraxane jista ’ jikkawża effetti sekondarji bħal għeja (komuni ħafna) u sturdament (komuni) li jistgħu jkollhom effett ħażin fuq il- ħila biex issuq u tħaddem magni. ll- pazjenti għandhom ikunu mwissija biex la jsuqu u l - anqas iħaddmu magni jekk iħossuhom għajjenin jew storduti.
The following are the most common and important incidences of adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/ m2 Abraxane once every three weeks in the pivotal phase III clinical study.
L- inċidenzi ta ’ avvenimenti avversi li ġejjin huma ta ’ l- iktar reazzjonijiet komuni u importanti fl - istudju kliniku importanti ħafna ta ’ fażi III ta ’ 229 pazjent b’ kanċer metastatiku tas- sider li kienu kkurati b’ 260 mg/ m2 ta ’ Abraxane darba kull tliet ġimgħat.
Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients.
In- newtropenja kienet l- iktar tossiċità ematoloġika notevoli (irrappurtata f’ 79% tal- pazjenti), u kienet riversibbli fi żmien qasir u skond id- doża; il- lewkopenja kienet irrappurtata f’ 71% tal- pazjenti.
Grade 4 neutropenia (< 0.5 x 109/ l) occurred in 9% of patients treated with Abraxane.
Newtropenja ta ’ Grad 4 (< 0. 5 x 109/ l) seħħet f’ 9% ta ’ pazjenti kkurati b’ Abraxane.
Febrile neutropenia occurred in four patients on Abraxane.
Newtropenja bid- deni seħħet f’ erba ’ pazjenti fuq Abraxane.
Anaemia (Hb < 10 g/ dl) was observed in 46% of patients on Abraxane, and was severe (Hb < 8 g/ dl) in three cases.
L- anemija (Hb < 10 g/ dl) kienet osservata f’ 46% tal- pazjenti li kienu fuq Abraxane, u kienet severa (Hb < 8 g/ dl) fi tliet każijiet.
Lymphopenia was observed in 45% of the patients.
Il- limfopenija kienet osservata f’ 45% tal- pazjenti.
In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving Abraxane.
B’ mod ġenerali, il- frekwenza u s- severità tan- newrotossiċità kienet tiddependi mid- doża f’ pazjenti li kienu qed jirċievu Abraxane.
Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on Abraxane with 10% being Grade 3, and no cases of Grade 4.
Newropatija periferali (l- aktar komuni newropatija sensorja ta ’ Grad 1 jew 2) kienet osservata fi 68% tal- pazjenti li kienu fuq Abraxane, b’ 10% li kienu ta ’ Grad 3, u l- ebda każijiet ta ’ Grad 4.
Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Id- dardir instab f’ 29% tal- pazjenti u d- dijarea seħħet f’ 25% tal- pazjenti.
Skin and subcutaneous system disorders:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda:
Alopecia was observed in 90% of the patients treated with Abraxane.
L- alopeċja kienet osservata f’ 90% tal- pazjenti kkurati b’ Abraxane.
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeletrali u tat- tessut konnettiv:
Arthralgia occurred in 32% of patients on Abraxane and was severe in 6% of cases.
L- artralġija seħħet fi 32% tal- pazjenti li kienu fuq Abraxane, u kienet severa f’ 6% tal- każijiet.
Myalgia occurred in 24% of patients on Abraxane and was severe in 7% of cases.
Il- majalġja seħħet f’ 24% tal- pazjenti li kienu fuq Abraxane, u kienet severa f’ 7% tal- każijiet.
The symptoms were usually transient, typically occurred three days after Abraxane administration and resolved within a week.
Normalment is- sintomi ma damux, tipikament bdew tlett ijiem wara l- għoti ta ’ Abraxane u fiequ fi żmien ġimgħa.
General disorders and administration site disorders:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
Asthenia/ Fatigue was reported in 40% of the patients.
Astenja/ għeja kbira kienu rrappurtati f’ 40% tal - pazjenti.
Table 1 lists adverse reactions associated with the administration of Abraxane to patients from studies in which Abraxane has been administered as a single agent at any dose in any indication (N = 789).
Tabella 1 telenka reazzjonijiet avversi wara l- għoti ta ’ Abraxane lil pazjenti, fi studji li fihom ingħata biss Abraxane bħala mediċina fi kwalunkwe doża fi kwalunkwe indikazzjoni (N = 789).
5 The frequency of undesirable effects listed in table 1 is defined using the following convention:
5 Il- frekwenza ta ’ l- effetti mhux mixtieqa elenkati f’ Tabella 1 hi definita bl- użu tal- konvenzjoni li ġejja:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla f’ ordni li tibda b’ dak l- iżjed serju u tispiċċa b’ dak l- inqas serju.
Adverse reactions reported with Abraxane at any dose in clinical trials.
Reazzjonijiet avversi rrappurtati b’ Abraxane fi kwalunkwe doża fi provi kliniċi.
Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased Investigations: gamma-glutamyltransferase, increased blood alkaline phosphatase
Tnaqqis fil- piż, żieda fl- alanine aminotransferase, żieda fl - aspartate aminotransferase, tnaqqis fl- ematokrit, tnaqqis fl- għadd taċ - ċelluli ħomor tad- demm, żieda fit- temperatura tal- ġisem, żieda fil - Investigazzjonijiet:
Increased blood pressure, increased weight, increased blood lactate dehydrogenase, increased blood creatinine, increased blood glucose, increased blood phosphorus, decreased blood potassium Cardiac disorders:
Żieda fil- pressjoni tad- demm, żieda fil- piż, żieda fil- lactate dehydrogenase fid- demm, żieda tal- krejatinina fid- demm, żieda tal- glucose fid- demm, żieda tal- phosphorus fid- demm, tnaqqis ta ’ potassium fid - demm
Tachycardia Very Common:
Takikardija (taħbit tal- qalb mgħaggel) Komuni Ħafna:
Neutropenia, anaemia, leukopenia, thrombocytopenia,
Newtropenja, anemija, lewkopenja, tromboċitopenja, limfopenja
Blood and lymphatic system disorders:
sistema limfatika:
lymphopenia Common:
Komuni:
Febrile neutropenia Very Common:
Newtropenja bid- deni
Nervous system disorders:
Komuni Ħafna:
Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence.
Newropatija sensorja periferali, uġigħ ta ’ ras, disturb fis- sens tat - Disturbi fis- sistema togħma, sturdament, newropatija tal- moviment tad- dirgħajn u s- saqajn, nervuża: atassja, disturb tas- sensi, ngħas tqil.
Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor Common:
Polinewropatija, assenza ta ’ riflessi, diskinesja, hyporeflexia, nevralġija, ma tibqax tħoss normali, sinkope, sturdament li jiddependi mill- pożizzjoni, uġigħ newropatiku, rogħda Komuni:
Increased lacrimation, blurred vision, dry eye, keratoconjunctivitis sicca, madarosis Eye disorders:
Żieda fl- ammont ta ’ dmugħ, vista mċajpra, għajnejn xotti, keratoconjunctivitis sicca, madarosis Disturbi fl- għajnejn:
Eye irritation, eye pain, abnormal vision, reduced visual acuity, conjunctivitis, visual disturbance, eye pruritus Ear and labyrinth disorders:
Irritazzjoni fl- għajnejn, uġigħ fl- għajnejn, vista mhix normali, tara inqas ċar, konġunktivite, disturb tal- vista, ħakk fl- għajnejn Disturbi fil- widnejn u fis- sistema labirintika:
Vertigo Uncommon:
Sturdament Mhux Komuni:
Ear pain, tinnitus Common:
Uġigħ fil- widnejn, żanżin fil- widnejn Komuni:
Dyspnoea, epistaxis, pharyngolaryngeal pain, cough, rhinitis, rhinorrhoea
Qtugħ ta ’ nifs, tinfaraġ, uġigħ faringolarinġejali, sogħla, rinite, tnixxija żejda mill- imnieħer
Respiratory, thoracic and mediastinal disorder:
Disturbi respiratorji, toraċiċi u medjastinali:
Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing
Sogħla bil- bili, qtugħ ta ’ nifs bl- istrapazz, konġestjoni tas - sinus, tnaqqis fil- ħsejjes tan- nifs, ħruġ ta ’ likwidu mill- plewra, rinite allerġika, tinħanaq, konġestjoni nażali, nixfa nażali, tħarħir
Interstitial pneumonitis Very Common:
Pnewmonite interstizjali
Common:
6 Tabella 1:
Abdominal pain, abdominal distension, upper abdominal pain, Gastrointestinal dyspepsia, gastrooesophageal reflux disease, oral hypoaesthesia disorders:
Reazzjonijiet avversi rrappurtati b’ Abraxane fi kwalunkwe doża fi provi kliniċi.
Uncommon:
Komuni Ħafna:
Dysuria, pollakiuria, haematuria, nocturia, polyuria, urinary incontinence
Dardir, dijarea, rimettar, stitikezza, stomatite
6 Table 1:
Komuni:
Adverse reactions reported with Abraxane at any dose in clinical trials.
Uġigħ ta ’ żaqq, nefħa taż- żaqq, uġigħ fin- naħa ta ’ fuq taż- żaqq, Disturbi gastro - dispepsja, mard tar- rifluss gastro- esofagali, ipoestesija orali intestinali:
Very Common:
Mhux Komuni:
Nail disorder, pruritus, dry skin, erythema, nail discolouration, skin hyperpigmentation, onycholysis Skin and subcutaneous tissue disorders:
Disturbi fid- dwiefer, ħakk, ġilda xotta, ġilda ħamra, tibdil fil - kulur tad- dwiefer, il- ġilda toskura, onikolisi (jinqalgħu id- dwiefer) Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda:
Nail bed tenderness, urticaria, skin pain, photosensitivity reaction, pigmentation disorder, pruritic rash, skin disorder, hyperhidrosis, onychomadesis, erythematous rash, generalised rash, dermatitis, night sweats, maculo-papular rash, vitiligo, hypotrichosis, nail discomfort, generalized pruritus, macular rash, papular rash, skin lesion, swollen face Very Common:
Sensittività fil- bażi tad- dwiefer, urtikarja, uġigħ fil- ġilda, reazzjoni tas- sensittività għad- dawl, disturbi tal- pigmentazzjoni, raxx pruritiku, disturbi fil- ġilda, iperidrosi, onikomadesi, raxx bil- ħmura, raxx ġeneralizzat, dermatite, għaraq matul il- lejl, raxx makulopapulari, vitiligo, ipotrikosi, skonfort fid- dwiefer, ħakk ġeneralizzat, raxx makulari, raxx papulari, leżjonijiet fil- ġilda, wiċċ minfuħ Komuni Ħafna:
Arthralgia, myalgia.
Artralġja, mijalġja
Musculoskeletal and connective tissue disorders:
Disturbi muskolu - skeltrali u tal- connective
Metabolism and nutrition disorders:
Uġigħ fl- estremitajiet, uġigħ fl- għadam, uġigħ fid- dahar, bugħawwieġ fil- muskoli, uġigħ fir- riġlejn jew fid- dirgħajn
Infections and
tissue:
Common:
Mhux Komuni:
Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness Very common:
Uġigħ fil- qafas tas- sider, dgħjufija fil- muskoli, uġigħ fl - għonq, uġigħ bejn il- koxxa u ż- żaqq, spażmi tal- muskoli, uġigħ muskoloskeletriku, uġigħ fil- ġenb tal- ġisem, diqa fir- riġlejn jew fid - dirgħajn, dgħjufija fil- muskoli Komuni ħafna:
Anorexia Common:
Nuqqas t’ aptit Komuni:
Dehydration, decreased appetite, hypokalaemia Uncommon:
Deidrazzjoni (telf ta ’ ilma mill- ġisem), nuqqas t’ aptit, ipokalemja
infestations:
u n- nutrizzjoni:
Injury, poisoning and procedural complications:
Infezzjonijiet u infestazzjonijiet:
Radiation recall phenomenon
Ipofosfatemja, akkumulazzjoni tal- fluwidu, ipoalbuminemja, polidipsja, ipergliċemja, ipokalċimja, ipogliċemja, iponatremja Komuni:
Vascular disorders:
Infezzjoni, infezzjoni fl- apparat urinarju, follikulite, infezzjoni fl - apparat respiratorju ta ’ fuq, kandidijasite, sinusite Mhux Komuni:
Metastatic pain, tumour necrosis Common:
Kontużjoni Korriment u avvelenament u komplikazzjonijiet ta ’ xi proċedura:
Flushing, hot flushes, hypertension, lymphoedema Uncommon:
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi):
Hypotension, peripheral coldness, orthostatic hypotension Rare:
Fenomenu tar- recall tar- radjazzjoni Mhux komuni:
Thrombosis Very Common:
Uġigħ metastatiku, nekrosi tat- tumur
Fatigue, asthenia, pyrexia.
Reazzjonijiet avversi rrappurtati b’ Abraxane fi kwalunkwe doża fi provi kliniċi.
General disorders and administration site conditions:
Fwawar, fwawar bis- sħana, pressjoni għolja, limfoedema