natgillin/translations-raw huggingface dataset:
Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine during the conduct of a trial in pancreatic adenocarcinoma.
O sepsi so poročali pri 5 % bolnikov z nevtropenijo ali brez nje, ki so prejemali zdravilo Abraxane v kombinaciji z gemcitabinom med preskušanjem pri adenokarcinomu trebušne slinavke.
pA+G/pG (95% CI)
HRA+G/G (95 % IZ)a p-vrednostb
Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with Abraxane.
Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijo med zdravljenjem z zdravilom Abraxane in do en mesec po zdravljenju.
Of the 421 patients with pancreatic adenocarcinoma in the randomized study who received Abraxane in combination with gemcitabine, 41% were 65 years and older and 10% were 75 years and older.
Od 421 bolnikov z adenokarcinomom trebušne slinavke v randomizirani študiji, ki so prejemali zdravilo Abraxane v kombinaciji z gemcitabinom, jih je bilo 41 % starih 65 let in več, 10 % pa 75 let in več.
Common: Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased gamma-glutamyltransferase, increased blood alkaline phosphatase
Pogosti: zmanjšana telesna masa, zvišana alanin-aminotransferaza, zvišana aspartat-aminotransferaza, znižana vrednost hematokrita, manjše število rdečih krvnih celic, zvišana telesna temperatura, zvišana gamaglutamiltransferaza, zvišana alkalna fosfataza v krvi
The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
V kliničnih študijah je bila določena farmakokinetika celokupnega paklitaksela po 30- in 180-minutni infuziji zdravila Abraxane pri odmerkih od 80 do 375 mg/m2.
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.
Periferno nevropatijo (večinoma senzorično nevropatijo 1. ali 2. stopnje) so opazili pri 68 % bolnikov, ki so prejemali zdravilo Abraxane.
In some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysaesthesiae have been reported as part of the continuing surveillance of Abraxane.
V okviru nadaljnjega spremljanja zdravila Abraxane so pri nekaterih bolnikih, ki so predhodno prejemali kapecitabin, poročali o palmarno-plantarni eritrodisesteziji.
Table 6: Adverse reactions reported with Abraxane monotherapy at any dose in clinical studies Infections and infestations
Preglednica 6: Neželeni dogodki, o katerih so poročali pri monoterapiji z zdravilom Abraxane v katerem koli odmerku v kliničnih študijah
Abraxane should not be administered until neutrophil counts recover to >1500 cells/mm3.
Zdravila Abraxane ni dovoljeno dajati, dokler število nevtrofilcev ne doseže vrednosti > 1.500 celic/mm3.
Abraxane (100 mg/m2/week) + carboplatin (N=521)
Zdravilo Abraxane (100 mg/m2/teden) + karboplatin (N=521)
Abraxane should be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Zdravilo Abraxane se jemlje pod nadzorom ustrezno usposobljenega onkologa v enoti, ki je specializirana za uporabo citotoksičnih snovi.
100 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Viala 100 ml (steklo tipa 1) z zamaškom (butilna guma), z zaporko (aluminij), ki vsebuje 250 mg paklitaksela, vezanega na albuminske nanodelce.
Pancreatic adenocarcinoma (Abraxane administered in combination with gemcitabine)
Adenokarcinom trebušne slinavke (zdravilo Abraxane uporabljeno skupaj z gemcitabinom)
MARKETING AUTHORISATION NUMBER(S) EU/1/07/428/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/428/001
At the clinical dose range of 80 to 300 mg/m2, the mean plasma clearance of paclitaxel ranges from 13 to 30 L/h/m2, and the mean terminal half-life ranges from 13 to 27 hours.
V mejah kliničnih odmerkov od 80 do 300 mg/m2 je povprečni plazemski očistek paklitaksela med 13
Women of childbearing age should use effective contraception during and up to 1 month after receiving treatment with Abraxane.
Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijo med zdravljenjem z zdravilom Abraxane in do 1 mesec po njem.
Gastrointestinal Toxicity: Grade 3 mucositis or diarrhoea
Toksičnost za prebavila: mukozitis 3. stopnje ali driska
Uncommon: Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor
Občasni: polinevropatija, arefleksija, diskinezija, hiporefleksija, nevralgija, senzorična izguba, sinkopa, posturalna omotičnost, nevropatska bolečina, tremor
The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Ni nujno, da pri pripravi ali dajanju infuzij zdravila Abraxane uporabljate specializirane vsebnike ali komplete za dajanje zdravila brez DEHP.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 100 mg paklitaksela, vezanega na albuminske nanodelce.
The recommended dose of Abraxane is 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of each 21-day cycle.
Priporočeni odmerek zdravila Abraxane je 100 mg/m2, ki se daje kot intravenska infuzija v času 30 minut 1., 8. in 15. dan vsakega 21-dnevnega cikla.
Common: Insomnia, depression, anxiety Uncommon: Restlessness
Pogosti: nespečnost, depresivnost, anksioznost Občasni: nemirnost
Beginning immediately after the end of Abraxane administration, carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 only of each 21-day cycle.
Takoj po končanem dajanju zdravila Abraxane so bolnikom samo 1. dan vsakega 21-dnevnega cikla dali karboplatin intravensko v odmerku AUC = 6 mg•min/ml.
Day 15: IF Day 8 doses were withheld: Day 15 ≥ 1000
15. dan: Če bolnik ni prejel odmerkov 8. dne: 15. dan ≥ 1.000
• Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight,
• bolečine nohtov, neugoden občutek nohtov, izguba nohtov, kožna bolečina, pordela koža zaradi sončne svetlobe, razbarvanje kože, povečano znojenje, nočno znojenje, bela območja na koži,
Table 7: Adverse reactions reported with Abraxane in combination with gemcitabine (N =421) Infections and infestations
Preglednica 7: Neželeni učinki, o katerih so poročali pri zdravilu Abraxane v kombinaciji z gemcitabinom (N =421)
Unopened vials: Keep the vial in the outer carton in order to protect from light.
Neodprte viale: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Solvent-based paclitaxel (200 mg/m2 every 3 weeks) + carboplatin (N=531)
Paklitaksel na bazi topila (200 mg/m2 vsake 3 tedne) + karboplatin (N=531)
After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.
Po rekonstituciji vsebuje 1 ml suspenzije 5 mg paklitaksela, vezanega na albuminske nanodelce.
Cycle Day
Dan cikla
Common: Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis
Pogosti: okužbe, okužbe sečil, folikulitis, okužbe zgornjih dihal, kandidoza, sinusitis
Patients should not be retreated with subsequent cycles of Abraxane until neutrophils recover to >1500 cells/mm3 and platelets recover to >100,000 cells/mm3 (see section
Nadaljnjih ciklov zdravila Abraxane ne smete začeti, dokler se nevtrofilci ne vrnejo na vrednost > 1.500 celic/mm3, trombociti pa na vrednost > 100.000 celic/mm3 (glejte poglavje 4.2).
Day 15: If Day 8 doses were given without modification: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
15. dan: Če so bili odmerki 8. dne dani brez sprememb: 15. dan ≥ 500 ali
There was a significant difference in overall response rate in the Abraxane/carboplatin arm compared to the control arm in patients with non-small cell lung cancer of squamous histology (N=450, 41% vs. 24%, p<0.001), however this difference did not translate into a difference in PFS or OS.
V skupini z zdravilom Abraxane/karboplatinom se je stopnja celokupnega odziva značilno razlikovala od kontrolne skupine pri bolnikih z nedrobnoceličnim pljučnim rakom s ploščatocelično histologijo (N=450, 41 % proti 24 %, p<0,001), vendar se ta razlika ni prenesla v razliko v PFS ali OS. Razlike v ORR med zdravljenima skupinama pri bolnikih z neploščatocelično histologijo ni bilo (N=602, 26 % proti 25 %, p=0,808).
Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression Common: Febrile neutropenia
Zelo pogosti: nevtropenija, anemija, levkopenija, trombocitopenija, limfopenija, supresija kostnega mozga Pogosti: febrilna nevtropenija
Common: Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes
Pogosti: motnje nohtov, srbenje, suha koža, eritem, obarvanje/razbarvanje nohtov, hiperpigmentacija kože, oniholiza, spremembe nohtov
The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Pomožna snov je humani albumin (ki vsebuje natrij, natrijev kaprilat in N-acetil DL triptofanat).
Very common: Fatigue, asthenia, pyrexia Common: Peripheral oedema, mucosal inflammation, pain, rigors, oedema, weakness, decreased performance status, chest pain, influenza-like illness, malaise, lethargy, hyperpyrexia
Zelo pogosti: utrujenost, astenija, pireksija Pogosti: periferni edem, vnetje sluznice, bolečine, okorelost, edem, šibkost, manjša zmogljivost, bolečine v prsih, gripi podobna bolezen, slabo počutje, letargija, hiperpireksija
Very common: Arthralgia, myalgia Common: Back pain, pain in extremity, musculoskeletal pain
Zelo pogosti: artralgija, mialgija Pogosti: bolečina v hrbtu, bolečina v udih, bolečina v mišicah in kosteh
Occurrence Dose of Abraxane (mg/m2)1
Pojavljanje Odmerek zdravila Abraxane (mg/m2)1
The recommended dose of Abraxane in combination with gemcitabine is 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle.
Priporočeni odmerek zdravila Abraxane v kombinaciji z gemcitabinom je 125 mg/m2, ki se daje intravensko 30 minut 1., 8. in 15. dan vsakega 28-dnevnega cikla.
The usual dose is for breast cancer is 260 mg/m2 of body surface area given over a 30 minute period.
Običajni odmerek pri raku dojk je 260 mg/m2 telesne površine.
Talk to your doctor or nurse if you experience any of these conditions whilst being treated with Abraxane, your doctor may wish to stop treatment or reduce the dose:
Posvetujte se z zdravnikom ali medicinsko sestro, če se vam pojavijo katere koli od spodaj navedenih težav, medtem ko vas zdravijo z zdravilom Abraxane.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/428/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/28/002
Very common: Rash, alopecia Common: Pruritus, nail disorder Uncommon: Skin exfoliation, dermatitis allergic, urticaria
Zelo pogosti: izpuščaj, alopecija Pogosti: pruritus, bolezni nohtov Občasni: luščenje kože, alergijski dermatitis, urtikarija
Abraxane Dose (mg/m2)
Odmerek zdravila Abraxane (mg/m2)
The concurrent recommended dose of gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Abraxane administration on Days 1, 8 and 15 of each 28-day cycle.
Sočasni priporočeni odmerek gemcitabina je 1.000 mg/m2, ki se daje intravensko 30 minut takoj po končanem dajanju zdravila Abraxane 1., 8. in 15. dan vsakega 28-dnevnega cikla.
• Gas, stomach cramps, painful or sore gums, rectal bleeding
• vetrovi, trebušni krči, bolečine ali razjede na dlesnih, krvavenje iz danke
The uncommon side effects may affect up to 1 in 100 people:
Občasni neželeni učinki se lahko pojavijo pri največ 1 od 100 bolnikov:
Common: Lacrimation increased Uncommon: Cystoid macular oedema
Pogosti: zvečano solzenje Občasni: cistoidni makularni edem
There were no clinically relevant pharmacokinetic interactions between Abraxane and carboplatin.
Med zdravilom Abraxane in karboplatinom ni bilo klinično pomembnih farmakokinetičnih interakcij.
Erlotinib should not be coadministered with Abraxane plus gemcitabine (see section 4.5).
Erlotiniba ne smete dajati skupaj s kombinacijo zdravila Abraxane in gemcitabina (glejte poglavje
• Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst,
• znižana raven fosforja v krvi, zadrževanje tekočine, znižana raven albumina v krvi, povečana žeja, znižana raven kalcija v krvi, znižana raven krvnega sladkorja, znižana raven natrija v krvi
• medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz,
sakvinavir, indinavir, nelfinavir, efavirenz, nevirapin)
Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Raztopina humanega albumina (vsebuje natrij, natrijev kaprilat in N-acetil DL triptofanat).
Table 3: Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma Adverse Drug Reaction (ADR)
Preglednica 3: Prilagajanje odmerka pri drugih neželenih učinkih zdravila pri bolnikih z adenokarcinomom trebušne slinavke
Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane.
Tako kot pri drugih potencialno toksičnih spojinah je treba tudi z zdravilom Abraxane previdno ravnati.
Abraxane was administered to patients (N=521) as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8 and
Bolnikom (N=521) so dajali zdravilo Abraxane v obliki intravenske infuzije 30 minut v odmerku 100 mg/m2 1.,
Bone marrow suppression (primarily neutropenia) occurs frequently with Abraxane.
Pri zdravilu Abraxane pogosto pride do zavrtja delovanja kostnega mozga (večinoma nevtropenija).
This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as Abraxane 260 mg/m2 given as a
To raziskavo so izvedli v več centrih pri bolnikih z metastatskim rakom dojk, ki so vsake 3 tedne prejemali paklitaksel kot samostojno zdravilo, ali kot paklitaksel na bazi topila v odmerku 175 mg/m2
What Abraxane is
Kaj je zdravilo Abraxane
In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving Abraxane.
Na splošno je bila pri bolnikih, ki so prejemali zdravilo Abraxane, pogostnost in resnost nevrotoksičnosti odvisna od odmerka.
Rare: Cystoid macular oedema2
Redki: cistoidni makularni edem2
Some people may feel tired or dizzy after being given Abraxane.
Po uporabi zdravila Abraxane so lahko nekateri ljudje utrujeni ali omotični.
Abraxane(125 mg/m2)/
Zdravilo Abraxane (125 mg/m2)/ gemcitabin gemcitabin
Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism
Občasni: produktiven kašelj, dispneja ob naporu, kongestija sinusov, plitvejši zvok dihanja, plevralni izliv, alergijski rinitis, hripavost, zamašitev nosu, suhost v nosu, piskanje v pljučih, pljučna embolija, pljučna trombembolija
Powder for suspension for infusion.
FARMACEVTSKA OBLIKA prašek za suspenzijo za infundiranje
Lung Cancer
Pljučni rak
Table 5: Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer Non-haematologic Toxicity
Preglednica 5: Zmanjšanje odmerka zaradi hematoloških toksičnosti pri bolnikih z nedrobnoceličnim pljučnim rakom
The rare side effects may affect up to 1 in 1,000 people:
Redki neželeni učinki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Pri 1.052 bolnikih z nedrobnoceličnim pljučnim rakom stadija IIIb/IV, ki prej še niso prejeli kemoterapije, so opravili multicentrično, randomizirano, odprto študijo.
(PT at Risk)
(navedeno v poglavju 6),
Each vial contains 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Ena viala vsebuje 100 mg ali 250 mg paklitaksela, vezanega na albuminske nanodelce.
Very common: Alopecia, rash Common: Pruritus, dry skin, nail disorder, flushing
Zelo pogosti: alopecija, izpuščaj Pogosti: pruritus, suha koža, bolezni nohtov, zardevanje
Common: Flushing, hot flushes, hypertension, lymphoedema Uncommon: Hypotension, peripheral coldness, orthostatic hypotension Rare: Thrombosis
Pogosti: zardevanje, vročinski oblivi, hipertenzija, limfedem Občasni: hipotenzija, občutek perifernega mrazenja, ortostatska hipotenzija
The very rare side effects may affect up to 1 in 10,000 people:
Zelo redki neželeni učinki se lahko pojavijo pri največ 1 od 10.000 bolnikov:
Patients received a median treatment duration of 3.9 months in the Abraxane/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the Abraxane/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
V skupini z zdravilom Abraxane/gemcitabinom je 32 % bolnikov prejelo 6 ali več mesecev zdravljenja, v skupini z gemcitabinom pa 15 %.
Hepatobiliary disorders Common: Cholangitis
Občasni: hepatomegalija
Solventbased paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL.
Paklitaksel na bazi topila so bolnikom (N=531) dali v odmerku 200 mg/m2 v obliki intravenske infuzije, ki je tekla 3 ure, s standardno premedikacijo, takoj nato je sledil
What Abraxane contains
Kaj vsebuje zdravilo Abraxane
Warnings and precautions Talk to your doctor or nurse before using Abraxane
Pred začetkom uporabe zdravila Abraxane se posvetujte z zdravnikom ali medicinsko sestro
*Median progression free survival [95% CI] (weeks)
*Mediana preživetja brez napredovanja bolezni [95 % IZ] (tedni)
Platelet count (cells/mm3)
Število krvnih ploščic (celice/mm3)
• Anxiety
• nemirnost
Pneumonitis has been reported at a rate of 4% with the use of Abraxane in combination with gemcitabine.
Pnevmonitis se je pojavil pri 4 % bolnikov, kadar so bolniki prejemali zdravilo Abraxane skupaj z gemcitabinom.
Reproductive system and breast disorders
Infekcijske in parazitske bolezni
Common: Vertigo Uncommon: Ear pain, tinnitus
Pogosti: vrtoglavica Občasni: bolečine v ušesih, tinitus
• Pain in the breast
• bolečine v prsih
Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Ena viala vsebuje 250 mg paklitaksela, vezanega na albuminske nanodelce.
Thus patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events.
Zaradi pojavljanja težav pri delovanju srca morajo biti bolniki, ki jemljejo zdravilo Abraxane, pod strogim nadzorom zdravnikov.
Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of Abraxane.
V obdobju spremljanja zdravila Abraxane po začetku trženja so opazili paralizo kranialnih živcev, parezo glasilk in redke primere reakcij hude preobčutljivosti.
There was a statistically significant improvement in PFS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS.
Pri bolnikih, zdravljenih z zdravilom Abraxane/gemcitabinom, v primerjavi s tistimi, ki so se zdravili samo z gemcitabinom, se je preživetje brez napredovanja bolezni statistično značilno izboljšalo, mediano preživetje brez napredovanja bolezni se je podaljšalo za 1,8 meseca.
Reconstitution and administration of the product
Rekonstitucija in dajanje zdravila
Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 250 mg vial of Abraxane over a minimum of 1 minute.
S sterilno brizgo počasi injicirajte 50 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v 250 mg vialo z zdravilom Abraxane najmanj 1 minuto.
Rare: Radiation recall phenomenon, radiation pneumonitis
Redki: preobčutljivost predhodno obsevanih predelov, obsevalni pnevmonitis
Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Abraxane over a minimum of 1 minute.
S sterilno brizgo počasi injicirajte 20 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v 100 mg vialo z zdravilom Abraxane najmanj 1 minuto.
• Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function,
• zvečana telesna masa, povišana laktat dehidrogenaza v krvi, zmanjšana funkcija ledvic, povišan krvni sladkor, povišana vrednost fosforja v krvi
Overall Survival Number of deaths, n (%) Median OS (95% CI) (months) HRA/T (95.1% CI)
Celokupno preživetje število smrti, n (%) mediana celokupnega preživetja (95 % IZ) (meseci)
A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients.
Pri bolnikih z nedrobnoceličnim pljučnim rakom so opravili farmakokinetično študijo z zdravilom Abraxane in karboplatinom.
If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water.
Če zdravilo Abraxane pride v stik s sluznico, jo takoj temeljito sperite z vodo.
When Abraxane is used as monotherapy, 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).
Če se razvije senzorična nevropatija 3. stopnje, ko se zdravilo Abraxane uporablja kot monoterapija, je treba zdravljenje prekiniti, dokler se le-ta ne izboljša do 1. ali 2. stopnje.
Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI)
smrt ali napredovanje bolezni, n (%) mediana preživetja brez napredovanja bolezni (95 % IZ) (meseci)
250 mg vial: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Viala z 250 mg: S sterilno brizgo počasi injicirajte 50 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v vialo z zdravilom Abraxane najmanj 1 minuto.
For treatment of non-small cell lung cancer Abraxane is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Abraxane dose has been given.
1., 8. in 15. dan 21-dnevnega cikla), skupaj s karboplatinom, ki se daje enkrat na tri tedne (t.j.
100 mg vial: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Viala s 100 mg: S sterilno brizgo počasi injicirajte 20 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v vialo z zdravilom Abraxane vsaj 1 minuto.
Administer Abraxane using an infusion set incorporating a 15 µm filter to avoid administration of these strands.
Da se boste izognili dajanju teh vlaken, dajajte zdravilo Abraxane z infuzijskim sistemom, ki vključuje 15 µm filter.
Very common: Nausea, diarrhoea, vomiting, constipation, abdominal pain, abdominal pain upper
Zelo pogosti: navzea, driska, bruhanje, zaprtost, bolečine v trebuhu, bolečina v zgornjem delu trebuha
Very common: Diarrhoea, vomiting, nausea, constipation
Zelo pogosti: slabost, driska, bruhanje, zaprtost, stomatitis
• Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)
• draženje oči, očesna bolečina, rdečina v očeh, srbenje oči, dvojni vid, poslabšanje vida,
Gemcitabine
Dojenje