natgillin/translations-raw huggingface dataset:
Paclitaxel blocks the ability of cancer cells to break down their internal ‘ skeleton ’ that allows them to divide and multiply.
Paklitaksel zavira sposobnost rakastih celic za razgradnjo njihovega notranjega „ skeleta “, ki jim omogoča, da se delijo in množijo.
With their skeleton still in place, the cells cannot divide and they eventually die.
Če ostane njihov skelet čvrsto na svojem mestu, se celice ne morejo deliti in sčasoma odmrejo.
Abraxane also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Zdravilo Abraxane deluje tudi na nerakaste celice, kakršne so krvne ali živčne celice, kar lahko povzroči neželene učinke.
Paclitaxel has been available as an anticancer medicine since 1993.
Učinkovina paklitaksel je na voljo kot zdravilo proti raku od leta 1993.
Conventional types of paclitaxel contain substances (solvents) that dissolve the paclitaxel, but can cause side effects.
Običajni tipi paklitaksela vsebujejo snovi (vehikle), ki raztopijo paklitaksel, vendar lahko povzročijo tudi neželene učinke.
Abraxane does not contain these solvents.
Zdravilo Abraxane teh vehiklov ne vsebuje.
Instead, the paclitaxel is attached to a human protein called albumin in tiny particles known as ‘ nanoparticles’.
Namesto tega je paklitaksel povezan s človeško beljakovino, imenovano albumin, ki se nahaja v majhnih delcih, imenovanih nanodelci.
This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Zaradi tega je priprava suspenzije paklitaksela za infundiranje v veno preprosta.
The nanoparticles may also affect the way the medicine is distributed within the
Nanodelci lahko vplivajo tudi na način porazdelitve zdravila v telesu in s tem na njegove koristne učinke in tveganja, kar ne velja za običajna zdravila, ki vsebujejo paklitaksel.
(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 Kako je bilo zdravilo Abraxane raziskano?
The effects of Abraxane were first tested in experimental models before being studied in humans.
Učinki zdravila Abraxane so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The company also presented data from the published literature.
Družba je predstavila tudi podatke iz izdane literature.
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.
Učinkovitost zdravila Abraxane so raziskovali v eni glavni študiji, ki je vključevala 460 žensk z metastatskim rakom na prsih, od katerih jih je približno tri četrtine v preteklosti prejemalo antraciklin.
Around half of the patients in the study had already received treatments for their cancer after it had become metastatic.
Približno polovica bolnic v študiji je že prejemala zdravila za zdravljenje raka po prehodu v metastatski stadij.
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).
Učinke zdravila Abraxane (kot samostojno zdravilo) so primerjali z učinki običajnega zdravila, ki vsebuje paklitaksel (dajanega skupaj z drugimi zdravili za ublažitev neželenih učinkov).
The main measure of effectiveness was the number of patients who ‘ responded ’ after at least five weeks of treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so se „ odzvali “ po najmanj petih tednih zdravljenja.
This was defined as the patient’ s main tumours having disappeared or having shrunk in size by at least 30%.
Odziv je bil opredeljen kot izginotje glavnih tumorjev ali njihovo skrčenje za vsaj 30% velikosti.
What benefit has Abraxane shown during the studies?
Kakšne koristi je zdravilo Abraxane izkazalo med raziskavami?
Abraxane was more effective than conventional paclitaxel-containing medicines.
Zdravilo Abraxane je bilo učinkovitejše od običajnih zdravil, ki vsebujejo paklitaksel.
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.
V glavni študiji se je na zdravljenje odzvalo 72 (31%) od 229 žensk, ki so prejemale zdravilo Abraxane, v primerjavi s 37 (16%) od 225 tistih, ki so prejemale običajna zdravila s paklitakselom.
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.
Če se osredotočimo samo na bolnice, ki so prejemale prvo zdravilo za zdravljenje metastatskega raka na prsih, ni bilo opaziti razlik med zdravili glede na merila učinkovitosti, kakršna sta čas do poslabšanja bolezni in stopnja preživetja.
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.
V nasprotju s tem so ti dodatni ukrepi pri bolnicah, ki so že jemale druga zdravila za zdravljenje metastatskega raka na prsih, izkazali večjo učinkovitost zdravila Abraxane v primerjavi z običajnimi zdravili, ki vsebujejo paklitaksel.
Therefore, the company withdrew its application for the use of Abraxane as first-line treatment during the assessment of the medicine.
Zato je družba med vrednotenjem zdravila umaknila svojo vlogo za uporabo zdravila Abraxane kot zdravila prve izbire.
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).
Najpogostejši neželeni učinki zdravila Abraxane (opaženi pri več kot 1 bolniku od 10) so nevtropenija (majhno število nevtrofilcev, vrste belih krvničk), anemija (majhno število rdečih krvničk), levkopenija (majhno število levkocitov, vrste belih krvničk), trombocitopenija (majhno število trombocitov), limfopenija (majhno število limfocitov, vrste belih krvničk), periferna nevropatija (poškodbe živcev rok in nog), nevropatija (poškodbe živcev), hipoestezija (poslabšan čut dotika), parestezija (nenavadni občutki, podobni mravljinčenju), navzea (občutek slabosti), diareja, bruhanje, zaprtost, stomatitis (vnetje ustne sluznice), alopecija (izguba las), izpuščaj, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), anoreksija (izguba teka), utrujenost, astenija (šibkost) in pireksija (visoka telesna temperatura).
For the full list of all side effects reported with Abraxane, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Abraxane, glejte Navodilo za uporabo.
Abraxane should not be used in people who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients.
Zdravila Abraxane ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) paklitaksel ali katerokoli drugo sestavino zdravila.
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.
Prav tako ga ne smejo uporabljati bolnice, ki dojijo ali ki imajo pred začetkom zdravljenja v krvi nizke ravni nevtrofilcev.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je bilo zdravilo Abraxane pri bolnikih, pri katerih je prvo zdravljenje nehalo učinkovati, učinkovitejše od običajnih zdravil, ki vsebujejo paklitaksel, in da za razliko od drugih takih zdravil ne potrebuje dodatnih zdravil za blaženje neželenih učinkov.
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.
Odbor je sklenil, da so koristi zdravila Abraxane pri zdravljenju metastatskega raka na prsih pri bolnikih, pri katerih zdravilo prve izbire za metastatske bolezni ni bilo uspešno in pri katerih zdravljenje z običajnimi zdravili, ki vsebujejo antraciklin, ni indicirano, večje od z njim povezanih tveganj.
The Committee recommended that Abraxane be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Abraxane.
Other information about Abraxane:
Druge informacije o zdravilu Abraxane:
The European Commission granted a marketing authorisation valid throughout the European Union for Abraxane to Abraxis BioScience Limited on 11 January 2008.
Evropska komisija je dovoljenje za promet z zdravilom Abraxane, veljavno po vsej Evropski uniji, odobrila družbi Abraxis BioScience Limited dne 11. januarja 2008.
The full EPAR for Abraxane can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Abraxane je na voljo tukaj.
This summary was last updated in 11-2007.
Povzetek je bil nazadnje posodobljen 11- 2007.
EU/ 1/ 07/ 428/ 001
Številka EU EU/ 1/ 07/ 428/ 001
Abraxane
Izmišljeno ime Abraxane
5 mg/ ml
jakost 5 mg/ ml
Powder for suspension for infusion
farmacevtska oblika Prašek za suspenzijo za infundiranje
Intravenous use
pot uporabe Intravenozna uporaba
vial (glass)
ovojnina viala (steklo)
100 mg
vsebina 100 mg
1 vial
velikost pakiranja 1 viala
ANNEX 1
DODATEK 1
Abraxane 5 mg/ ml powder for suspension for infusion.
Abraxane 5 mg/ ml prašek za suspenzijo za infundiranje.
Each vial contains 100 mg of paclitaxel.
Vsaka viala vsebuje 100 mg paklitaksela.
After reconstitution, each ml of suspension contains 5 mg of paclitaxel.
Po rekonstituciji vsebuje vsak ml suspenzije 5 mg paklitaksela.
Excipients The reconstituted medicinal product contains approximately 425 mg sodium per dose.
Pomožne snovi Rekonstituirano zdravilo vsebuje približno 425 mg natrija na odmerek.
The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/ kg.
Rekonstituirana suspenzija ima pH vrednost 6- 7, 5 in osmolalnost 300- 360 mOsm/ kg.
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).
Kot samostojno zdravilo je Abraxane indiciran za zdravljenje metastatskega raka na prsih pri bolnikih, pri katerih je bilo zdravljenje prve izbire neuspešno, ali pri bolnikih, pri katerih zdravljenje z antraciklinom ni indicirano (glejte tudi poglavje 4. 4).
Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Abraxane se jemlje pod nadzorom kvalificiranega onkologa v enoti, ki je specializirana za uporabo citotoksičnih snovi.
The procedure for reconstitution is described in section 6.6.
Postopek rekonstitucije je opisan v poglavju 6. 6.
The recommended dose of Abraxane is 260 mg/ m2 administered intravenously over 30 minutes every 3 weeks.
Priporočeni odmerek zdravila Abraxane je 260 mg/ m2 intravensko 30 minut na vsake 3 tedne.
Dose adjustments during treatment:
Prilagajanje odmerka med zdravljenjem:
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.
Pri bolnikih, ki imajo med zdravljenjem z zdravilom Abraxane hudo nevtropenijo (število nevtrofilcev < 0, 50 x 109/ l v obdobju enega tedna ali dlje) ali hudo senzorično nevropatijo, je treba odmerek zmanjšati na 220 mg/ m2 za vsa nadaljnja zdravljenja.
Following recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/ m2.
Ob ponovitvi hude nevtropenije ali hude senzorične nevropatije je treba odmerek dodatno zmanjšati na 180 mg/ m2.
Abraxane should not be administered until neutrophil counts recover to > 1.5 x 109/ l.
Zdravila Abraxane se ne sme dajati, dokler število nevtrofilcev ne doseže vrednosti > 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.
Pri senzorični nevropatiji 3. stopnje prekinite zdravljenje, dokler se le- ta ne spusti na 1. ali 2. stopnjo, nato zmanjšajte odmerek za vsa nadaljnja zdravljenja.
2 Patients with hepatic impairment:
2 Bolniki z okvarami jeter:
Insufficient data are currently available to recommend dose modifications in patients with mild to moderate hepatic impairment (see sections 4.4. and 5.2).
Trenutno ni na voljo podatkov, ki bi priporočali prilagajanje odmerkov pri bolnikih z blago do zmerno okvaro jeter (glejte poglavji 4. 4. in 5. 2).
Patients with severe hepatic impairment should not be treated with paclitaxel.
Bolniki s hudo okvaro jeter ne smejo prejemati paklitaksela.
Patients with impaired renal function:
Bolniki z okvarami ledvic:
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).
Raziskave pri bolnikih z okvarami ledvic niso bile opravljene in trenutno ni na voljo zadosti podatkov, ki bi priporočali prilagajanje odmerkov pri bolnikih z okvarami ledvic (glejte poglavje 5. 2).
Abraxane is not recommended for use in children below age 18 years due to insufficient data on safety and efficacy.
Uporaba zdravila Abraxane pri otrocih, mlajših od 18 let, ni priporočljiva zaradi pomanjkljivih podatkov o varnosti in učinkovitosti.
In the clinical studies, no toxicities occurred notably more frequently among elderly patients who received Abraxane.
V kliničnih raziskavah se ni pojavila opazno pogostejša toksičnost pri starejših bolnikih, ki so jemali Abraxane.
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost na učinkovino ali katerokoli pomožno snov.
Lactation.
Dojenje.
Patients who have baseline neutrophil counts < 1.5 x 109/ l.
Bolniki, ki imajo izhodiščno število nevtrofilcev < 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)..
Zdravilo Abraxane je albuminsko vezana formulacija paklitaksela v obliki nanodelcev, ki ima lahko bistveno drugačne funkcionalne značilnosti kot druge formulacije paklitaksela (glejte poglavji 5. 1 in 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.
Če se pojavi preobčutljivost, je treba takoj prekiniti uporabo zdravila; uvede se simptomatsko zdravljenje, bolniku pa se ne sme ponovno dajati paklitaksela.
Haematology:
Hematologija:
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.
Nadaljnjih ciklov zdravila Abraxane se ne sme začeti, dokler se nevtrofilci ne vrnejo na vrednost > 1, 5 x 109/ l, tromobociti pa na vrednost > 100 x 109/ l.
Neuropathy:
Nevropatija:
The occurrence of grade 1 or 2 sensory neuropathy does not generally require dose reduction.
Če se pojavi senzorična nevropatija 1. ali 2. stopnje, odmerka navadno ni treba zmanjšati.
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).
(glejte poglavje 4. 2).
3 Hepatic Impairment:
3 Okvare jeter:
Patients with hepatic impairment may be at increased risk of toxicity, particularly from myelosuppression, and such patients should be closely monitored for development of profound myelosuppression.
Takšne bolnike je treba strogo nadzorovati zaradi morebitnega pojava izrazite mielosupresije.
The use of Abraxane has not been formally studied in patients specifically with hepatic impairment.
Do sedaj še ni bilo nobenih uradnih raziskav o uporabi zdravila Abraxane pri bolnikih z okvarami jeter.
Patients with severe hepatic impairment (bilirubin > 5 x ULN or ASL/ ALT > 10 x ULN) should not be treated with Abraxane.
Bolniki s hudimi okvarami jeter (bilirubin > 5 x ULN ali ASL/ ALT > 10 x ULN) ne smejo jemati zdravila Abraxane.
The appropriate dose regimen in patients with less severe hepatic impairment is unknown.
Ustrezen režim odmerjanja pri bolnikih s zmernimi okvarami jeter ni znan.
Cardiotoxicity:
Kardiotoksičnost:
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.
Čeprav kardiotoksičnost, ki bi bila neizpodbitno povezana z zdravilom Abraxane, ni bila dokazana, težave z delovanjem srca niso neobičajne pri indicirani populaciji, še posebej pri bolnikih, ki so predhodno jemali antracikline oziroma ki imajo osnovno bolezen srca ali pljuč.
Thus patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events.
Zaradi pojavov težav z delovanjem srca morajo biti bolniki, ki jemljejo Abraxane, pod strogim nadzorom zdravnikov.
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).
Spolno aktivni moški in ženske naj uporabljajo učinkovite kontracepcijske metode med zdravljenjem; moški naj z metodami nadaljujejo še šest mesecev po zdravljenju, ženske pa en mesec po zdravljenju (glejte poglavje 4. 6).
The effectiveness and safety of Abraxane in patients with central nervous system (CNS) metastases has not been established.
Učinkovitost in varnost zdravila Abraxane pri bolnikih z metastazami v centralnem živčnem sistemu (CŽS) nista bili proučevani.
Gastrointestinal Symptoms:
Gastrointestinalni simptomi:
If patients experience nausea, vomiting and diarrhoea following the administration of Abraxane, they may be treated with commonly used anti-emetics and constipating agents.
Če se pri bolnikih pojavijo slabost, bruhanje in driska po prejetju zdravila Abraxane, se jih lahko zdravi z običajnimi anti- emetiki in zdravili proti zaprtju.
When reconstituted, Abraxane contains approximately 425 mg sodium per dose.
Po rekonstituciji vsebuje Abraxane približno 425 mg natrija na odmerek.
4.5 Interactions with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
No interaction studies have been performed.
Raziskave o interakcijah niso bile opravljene.
The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Metabolizem paklitaksela katalizirata - deloma - izoencima CYP2C8 in CYP3A4 citokroma P450 (glejte poglavje 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.
Zato je treba paziti pri sočasnem dajanju paklitaksela in zdravil, ki znano zavirajo (npr. eritromicin, fluoksetin, protiglivična sredstva imidazola) ali izzivajo (npr. rifampicin, karbamazepin, fenitoin, efavirenz, nevirapin) CYP2C8 oziroma CYP3A4.
Abraxane is indicated for mono-therapy.
Abraxane je indiciran za monoterapijo.
There are very limited data on the use of paclitaxel in human pregnancy.
Obstajajo le zelo omejeni podatki o uporabi paklitaksela med nosečnostjo pri ljudeh.
Paclitaxel is suspected to cause serious birth defects when administered during pregnancy.
Obstaja sum, da paklitaksel povzroča resne prirojene okvare, če se ga jemlje med nosečnostjo.
Studies in animals have shown reproductive toxicity (see section 5.3).
Raziskave pri živalih so pokazale reproduktivno toksičnost (glejte poglavje 5. 3).
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.
Zdravila Abraxane se ne sme dajati nosečnicam in ženskam v rodni dobi, ki ne uporabljajo zanesljive kontracepcije, razen če je zdravljenje s paklitakselom nujno zaradi kliničnega stanja matere.
4 Women of childbearing potential should use effective contraception during and up to 1 month after receiving treatment with Abraxane.
4 Ženske v rodni dobi naj uporabljajo učinkovito kontracepcijo med in en mesec po zdravljenju z zdravilom Abraxane.
It is not known if paclitaxel is excreted in human milk.
Ni znano, ali se paklitaksel izloča v mleko matere.
Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation.
Zaradi morebitnih hudih neželenih dogodkov pri dojenčkih je Abraxane med dojenjem kontraindiciran.
Breastfeeding must be discontinued for the duration of therapy.
V času zdravljenja je treba dojenje prekiniti.
Abraxane induced infertility in male rats (see section 5.3).
Zdravilo Abraxane je povzročilo neplodnost pri samcih podgan (glejte poglavje 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.
Moški bolniki naj se posvetujejo o shrambi semenske tekočine pred začetkom zdravljenja zaradi možne ireverzibilne neplodnosti kot posledice zdravljenja z zdravilom Abraxane.
Abraxane has minor or moderate influence on the ability to drive and use machines.
Zdravilo Abraxane ima manjhen do zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Abraxane may cause side effects such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery.
Abraxane ima lahko neželene učinke, kot je utrujenost (zelo pogosto) in omotičnost (pogosto), ki lahko vplivajo na sposobnost upravljanja vozil in strojev.
Patients should be advised not to drive and use machines if they feel tired or dizzy.
Bolnikom se svetuje, da ne vozijo in upravljajo s stroji, če so utrujeni ali se jim vrti.
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.
Spodaj so navedeni najbolj pogosti in pomembni pojavi neželenih učinkov pri 229 bolnikih z metastatskim rakom na prsih, ki so jemali enkraten odmerek 260 mg/ m2 zdravila Abraxane vsake tri tedne v ključni klinični raziskavi 3. faze.