natgillin/translations-raw huggingface dataset:
Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6α -hydroxypaclitaxel; and to two minor metabolites, 3’ -p-hydroxypaclitaxel and 6α -3’ -p-dihydroxypaclitaxel.
Kot je navedeno v objavljeni literaturi, in vitro raziskave z mikrosomi človeških jeter in rezin tkiva kažejo, da se paklitaksel večinoma metabolizira v 6α- hidroksipaklitaksel in v dva manjša metabolita, in sicer, 3 ’ - p- hidroksipaklitaksel in 6α- 3 ’ - p- dihidroksipaklitaksel.
The formation of these hydroxylated metabolites is catalysed by CYP2C8, -3A4, and both -2C8 and -3A4 respectively.
Formacijo teh hidroksiliranih metabolitov katalizirajo CYP2C8, - 3A4 ter oba - 2C8 in - 3A4.
The effect of renal or hepatic dysfunction on the disposition of paclitaxel has not been formally investigated.
Učinek okvar ledvic ali jeter na dispozicijo paklitaksela ni bil formalno preiskovan.
In patients with metastatic breast cancer, after a 30 minute infusion of Abraxane at 260 mg/ m2, the mean value for cumulative urinary excretion of unchanged active substance accounted for 4% of the total administered dose with less than 1% as the metabolites 6α -hydroxypaclitaxel and 3’ -p-hydroxypaclitaxel, indicating extensive non-renal clearance.
Pri bolnikih z metastatskim rakom prsi, po 30- minutnem infundiranju zdravila Abraxane pri 260 mg/ m2, je bila povprečna vrednost kumulativnega izločanja nespremenjene učinkovine prek urina 4% celokupnega prejetega odmerka z manj kot 1% metabolitov 6α- hidroksipaksitaksela in 3 ’ - p - hidroksipaklitaksela, kar nakazuje velik neledvični očistek.
Paclitaxel is principally eliminated by hepatic metabolism and biliary excretion.
Paklitaksel se večinoma izloči z jetrnim metabolizmom in izločanjem žolča.
Pharmacokinetics of paclitaxel in patients aged over 65 years seems comparable to that in patients less than 65 years.
Farmakokinetika paklitaksela pri bolnikih, starejših od 65 let, se zdi primerljiva s farmakokinetiko pri bolnikih, mlajših od 65 let.
However, little information in patients over 75 years is available as only 3 patients over 75 years of age where included in the pharmacokinetic analysis.
Vendar pa je le malo podatkov o bolnikih, starejših od 75 let, saj so bili v farmakokinetično analizo vključeni le 3 bolniki, ki so bili starejši od 75 let.
However, based on the published literature, paclitaxel is a potentially carcinogenic and genotoxic agent at clinical doses, based upon its pharmacodynamic mechanism of action.
Z ozirom na objavljeno literaturo pa je paklitaksel potencialno kancerogen in genotoksičen v kliničnih odmerkih, glede na farmakodinamičen
10 in the Ames test or the Chinese hamster ovary/ hypoxanthine-guanine phosphoribosyl transferase (CHO/ HGPRT) gene mutation assay.
Paklitaksel se je izkazal za klastogenega v in vitro (kromosomske spremembe v človeških limfocitih) in in vivo okolju (mikronukleusni test pri miših).
Paclitaxel at doses below the human therapeutic dose was associated with low fertility and foetal toxicity in rats.
Paklitaksel v odmerkih, manjših od človeškega terapevstskega odmerka, so povezovali z nizko plodnostjo in fetalno toksičnostjo pri podganah.
Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Raztopina človeškega albumina (vsebuje natrij, natrijev kaprilat in N- acetil DL triptofanat).
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 6.
Stability of reconstituted suspension in the vial:
Stabilnost rekonstituirane suspenzije v viali:
However, chemical and physical in use stability has been demonstrated for 8 hours at 2°C - 8°C in the original carton, and protected from bright light.
Ugotovilo pa se je, da kemijska in fizikalna stabilnost med uporabo traja 8 ur pri 2 °C - 8 °C, v originalni embalaži in zaščiteno pred močno svetlobo.
Stability of the reconstituted suspension in the infusion bag:
Stabilnost rekonstituirane suspenzije v infuzijski vrečki:
Keep the vial in the outer carton in order to protect from light.
Hranite vialo zaščiteno pred svetlobo v zunanjem kartonu.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Za pogoje hranjenja rekonstituiranega zdravila glejte poglavje 6. 3.
Vial 50ml (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium).
Viala 50 ml (steklo tipa 1) z zamaškom (butilna guma), z zaporko (aluminij).
Pack size one vial of 100 mg paclitaxel.
Velikost pakiranja: ena viala s 100 mg paklitaksela.
Preparation and administration precautions:
Previdnostni ukrepi pri pripravi in dajanju zdravila
If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Če pride v stik s sluznico, le- to temeljito sperite z vodo.
11 Reconstitution and administration of the product:
11 Rekonstitucija in administracija zdravila:
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.
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.
Then, the vial should gently and slowly be swirled and/ or inverted for at least 2 minutes until complete resuspension of any powder occurs.
Nato vialo pazljivo in počasi sučite in/ ali obračajte vsaj 2 minuti, dokler se ves prašek popolnoma ne resuspendira.
If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.
Če pride do tvorbe oborin ali usedanja, vialo ponovno pazljivo obračajte navzgor in navzdol, da boste zagotovili popolno resuspenzijo pred uporabo.
Complete resuspension should be ensured by mild agitation before use.
Pred uporabo z rahlim stresanjem zagotovite popolno resuspenzijo.
Discard the reconstituted suspension if precipitates are observed.
Zavrzite rekonstituirano suspenzijo, če opazite oborine.
Calculate the exact total dosing volume of 5 mg/ ml suspension required for the patient and inject the appropriate amount of reconstituted Abraxane into an empty, sterile, PVC or non-PVC type intravenous bag.
Izračunajte natančen celokupen volumen odmerka 5 mg/ ml suspenzije, ki ga potrebuje bolnik, nato pa ustrezno količino rekonstituiranega zdravila Abraxane injicirajte v prazno, sterilno intravensko vrečko, polivinilkloridnega (PVC) ali ne- polivinilkloridnega tipa.
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 brez DEHP ali komplete za dajanje zdravila.
In-line filters should not be used.
Ne uporabljajte notranjih filtrov[ a1].
Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ United Kingdom
Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ Velika Britanija
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE / PODALJŠANJA DOVOLJENJA ZA PROMET
DATE OF LAST REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA
12 ANNEX II
12 DODATEK II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX United Kingdom
Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX Velika Britanija
Medicinal product subject to restricted medical prescription (See Annex I:
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I:
Summary of Product Characteristics, section 4.2).
Povzetek glavnih značilnosti zdravila, poglavje 4. 2).
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet mora zagotoviti, da pred dajanjem zdravila v promet in v času trženja zdravila deluje sistem farmakovigilance, kakor je opisan v različici 2. 0 v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) and presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt obravnavanja tveganja Imetnik dovoljenja za promet se obvezuje k izvedbi raziskav in dodatnih farmakovigilančnih aktivnosti, ki so podrobno opisane v načrtu farmakovigilance v 4. različici načrta obravnavanja tveganj (RMP) in modulu 1. 8. 2. vloge za dovoljenje za promet ter vseh dopolnilih RMP, odobrenih s strani CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skladno s smernicami CHMP o sistemih obravnavanja tveganja zdravil za uporabo v humani medicini se mora popravljen RMP vložiti sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Ne glede na to, je treba vložiti dopolnjen RMP: • v primeru ugotovitev, ki lahko vplivajo na trenutno varnostno specifikacijo, načrt farmakovigilance ali dejavnosti za zmanjšanje tveganja, • v 60 dneh po doseženem pomembnem mejniku (v farmakovigilanci ali dejavnostih za zmanjšanje tveganja), • na zahtevo EMEA.
14 ANNEX III
14 DODATEK III
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING Carton and Vial
16 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Karton in viala
Abraxane 5 mg/ml powder for suspension for infusion
Abraxane 5 mg/ ml prašek za suspenzijo za infundiranje
Each vial contains 100 mg paclitaxel.
Vsaka viala vsebuje 100 mg paklitaksela.
Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate)
Raztopina človeškega albumina (vsebuje natrij, natrijev kaprilat in N- acetil DL triptofanat).
Powder for suspension for infusion One vial of 100 mg paclitaxel
Ena viala s 100 mg paklitaksela
Single use vial Intravenous use
Viala za enkratno uporabo Intravenozna uporaba
Only to be prepared and administered by personnel appropriately trained in handling cytotoxics.
Pripravi in daje le osebje, ki je ustrezno usposobljeno za rokovanje s citotoksiki.
Abraxane may have substantially different pharmacological properties compared to other paclitaxel formulations.
Zdravilo Abraxane ima lahko v primerjavi z drugimi oblikami paklitaksela bistveno drugačne farmakološke lastnosti.
EXP IRY DATE
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Unopened Vials:
Neodprte viale:
After first reconstitution:
Po prvi rekonstituciji:
8 hours in a refrigerator in the vial when kept in the outer carton in order to protect from light.
8 ur v hladilniku v viali, če se jo hrani zaščiteno pred svetlobo v zunanjem kartonu.
In an infusion bag: up to 8 hours not above 25oC
V infuzijski vrečki: do 8 ur pri temperaturi do 25 oC
19 PACKAGE LEAFLET:
19 NAVODILO ZA UPORABO
Abraxane 5 mg/ml powder for suspension for infusion Paclitaxel
Abraxane 5 mg/ ml prašek za suspenzijo za infundiranje paklitaksel
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
please tell your doctor.
omenjen v tem navodilu, obvestite svojega zdravnika.
What Abraxane is and what it is used for 2.
Kaj je zdravilo Abraxane in za kaj ga uporabljamo 2.
Before you use Abraxane 3.
Kaj morate vedeti, preden boste uporabili zdravilo Abraxane 3.
How to use Abraxane 4.
Kako uporabljati zdravilo Abraxane 4.
How to store Abraxane 6.
Shranjevanje zdravila Abraxane 6.
WHAT ABRAXANE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ABRAXANE IN ZA KAJ GA UPORABLJAMO
Abraxane is a medicine containing paclitaxel in human albumin (portion of blood).
Abraxane je zdravilo, ki vsebuje paklitaksel v človeškem albuminu (sestavina krvi).
Paclitaxel belongs to a group of medicines called taxanes used to treat cancers.
Paklitaksel sodi v skupino zdravil, ki jih imenujemo taksani in jih uporabljamo za zdravljenje raka.
Abraxane is used for the treatment of breast cancer when other therapies have been tried but have not worked and if you are unsuitable for anthracycline containing treatments.
Zdravilo Abraxane se uporablja za zdravljenje raka prsi, kadar druga zdravljenja niso bila uspešna ali kadar zdravljenje z antraciklini ni primerno.
BEFORE YOU USE ABRAXANE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ABRAXANE
Do not use Abraxane • if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane • if you are breast feeding • if you have a low white blood cell count (baseline neutrophil counts < 1.5 x 109/l - your doctor will advise you on this)
Ne jemljite zdravila Abraxane: • če ste alergični na (preobčutljivi za) paklitaksel ali katerokoli drugo sestavino zdravila Abraxane; • če dojite; • če imate nizko število belih krvničk (osnovno število nevtrofilcev < 1, 5 x 109/ l - o tem se boste pogovorili z vašim zdravnikom).
Take special care with Abraxane • if you have poor kidney function • if you experience numbness, tingling, pricking sensations, sensitivity to touch, or muscle weakness • if you have severe liver problems • if you have heart problems
Bodite posebno pozorni pri uporabi zdravila Abraxane: • če imate zmanjšano delovanje ledvic • če začutite odrevenelost, mravljinčenje, zbadanje, občutljivost na dotik ali šibkost mišic • če imate hude težave z jetri • če imate težave s srcem.
If you experience any of these conditions your doctor may wish to stop treatment or reduce the dose.
Če boste imeli katerekoli od zgoraj navedenih težav, se bo morda vaš zdravnik odločil zaključiti zdravljenje ali pa znižati odmerek.
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, because they could interact with Abraxane.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta, saj bi lahko povzročila medsebojno delovanje z zdravilom Abraxane.
Using Abraxane with food and drink Abraxane is unaffected by food and drink.
Hrana in pijača ne vplivata na zdravilo Abraxane.
Pregnancy and breast-feeding Paclitaxel may cause serious birth defects and should therefore not be used if you are pregnant.
Paklitaksel lahko povzroči hude prirojene okvare, zato ga nosečnice ne smejo jemati.
20 Women of childbearing age should use effective contraception during and up to 1 month after receiving treatment with Abraxane.
20 Ženske v rodni dobi naj uporabljajo učinkovito kontracepcijo med in en mesec po zdravljenju z zdravilom Abraxane.
Male patients are advised to not father a child during and up to six months after treatment and should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Posvetujejo naj se o shrambi semenske tekočine pred zdravljenjem zaradi možne ireverzibilne neplodnosti kot posledice zdravljenja z zdravilom Abraxane.
It is not known if paclitaxel passes into breast milk.
Ni znano, ali se paklitaksel izloča v mleko matere.
Because of the possibility of harm to the infant, breast-feeding must be discontinued for the duration of treatment.
Zaradi morebitnih posledic za dojenčke, je treba dojenje med zdravljenjem prekiniti.
Driving and using machines Abraxane may cause side effects such as tiredness (very common) and dizziness (common) that may affect your ability to drive and use machinery.
Vpliv na sposobnost upravljanja vozil in strojev Abraxane ima lahko neželene učinke, kot je utrujenost (zelo pogosto) in omotičnost (pogosto), ki lahko vplivajo na sposobnost upravljanja vozil in strojev.
If you experience these symptoms, do not drive or operate machinery until they have fully resolved.
Če se pojavijo ti simptomi, ne vozite ali upravljajte strojev, dokler se le- ti popolnoma ne odpravijo.
Important information about some of the ingredients of Abraxane This medicinal product contains approximately 425 mg sodium per dose.
Pomembne informacije o nekaterih sestavinah zdravila Abraxane To zdravilo vsebuje približno 425 mg natrija na odmerek.
This should be taken into consideration by patients on a controlled sodium diet.
To morajo upoštevati bolniki, ki so na dieti z omejenim vnosom natrija.
HOW TO USE ABRAXANE
KAKO UPORABLJATI ZDRAVILO ABRAXANE
Abraxane will be given to you by a doctor or nurse into a vein from an intravenous drip.
Abraxane vam bo dal zdravnik ali medicinska sestra v veno, z intravenozno kanilo.
The usual dose is 260 mg/m2 of body surface area.
Običajen odmerek je 260 mg/ m2 telesne površine.
Abraxane is usually given every three weeks.
Abraxane se navadno daje vsake tri tedne.
How long will it take to give you your intravenous drip?
Kako dolgo traja infuzija z intravenozno kanilo?
Abraxane is given over a 30 minute period.
Abraxane se daje 30 minut.
If you have any further questions on the use of this product ask your doctor.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
Like all medicines, Abraxane can cause side-effects, although not everyone gets them.
Kot vsa zdravila ima lahko tudi zdravilo Abraxane neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The very common side-effects (reported in at least 1 out of 10 patients) are: • Loss of hair • Abnormal decrease in the number of neutrophils in the blood • Decrease in the number of white blood cells in the blood • Deficiency of red blood cells • Reduction in the number of lymphocytes in the blood • Effect of peripheral nerves (pain, and numbness) • Pain in a joint or joints • Pain in the muscles • Nausea, diarrhoea • Vomiting • Weakness and tiredness
Zelo pogosti neželeni učinki (ki so jih opazili pri vsaj 1 od 10 bolnikov) so: • izpadanje las • abnormalno znižanje števila nevtrofilcev v krvi • znižanje števila belih krvničk • pomanjkanje rdečih krvničk • znižanje števila limfocitov v krvi • učinki perifernega živčevja (bolečine in odrevenelost) • bolečine v sklepu ali sklepih • bolečine v mišicah • slabost, driska • bruhanje • šibkost in utrujenost
21 • Throat or abdominal pain • Indigestion, abdominal discomfort, or constipation • Difficulty in breathing • Loss of appetite, weight loss • Bone pain, muscle pain • Dizziness, diminished muscular coordination or difficulty in reading • Changes in heart rate or rhythm • Swelling of mucosal and soft tissues, soreness of the mouth or tongue, oral thrush • Sleep problems
21 Pogosti neželeni učinki (ki so jih opazili pri vsaj 1 od 100 bolnikov) so: • kožni izpuščaji, srbenje, suha koža, motnje nohtov • okužba, vročica, rdečica • bolečine v grlu ali trebuhu • prebavne motnje, nelagodje v trebuhu ali zaprtje • težave pri dihanju • izguba apetita, zmanjšanje telesne teže • bolečine v kosteh, bolečine v mišicah • omotičnost, zmanjšana mišična koordinacija ali težave pri branju • spremembe srčnega utripa ali ritma • zatekanje sluzničnih in mehkih tkiv, bolečine v ustih ali jeziku, glivična okužba v ustih • težave s spanjem
The rare side-effects (reported in at least 1 in 10,000 patients) are: • Lung infection • Skin reaction to another agent following radiation • Blood clot
Redki neželeni učinki (ki so jih opazili pri vsaj 1 od 10. 000 bolnikov) so: • okužba pljuč • kožna reakcija na drugo zdravilo zaradi obsevanja • krvni strdek
If any of the side-effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
HOW TO STORE ABRAXANE
SHRANJEVANJE ZDRAVILA ABRAXANE
Do not use Abraxane after the expiry date which is stated on the carton and the vial after EXP.
Zdravila Abraxane ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
Keep the vial in the outer carton in order to protect from light.
Hranite vialo v zunanji embalaži zaščiteno pred svetlobo.
If not used immediately, the suspension may be stored in a refrigerator (2°C – 8°C) for up to 8 hours in the vial when kept in the outer carton in order to protect it from light.
Če je ne uporabite takoj, jo lahko shranite v hladilniku (2 °C – 8 °C) do 8 ur, če je v viali in zunanjem kartonu za zaščito pred svetlobo.
The reconstituted suspension in the intravenous drip may be stored for up to 8 hours at a temperature not above 25ºC.
Rekonstituirana suspenzija za intravenozno dajanje se lahko shranjuje do 8 ur pri temperaturi do 25 ºC.
• The active substance is paclitaxel.
• Zdravilna učinkovina je paklitaksel.
Each vial contains 100 mg of paclitaxel. • After reconstitution, each ml of suspension contains 5 mg of paclitaxel. • The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Vsaka viala vsebuje 100 mg paklitaksela. • Po rekonstituciji vsebuje vsak ml suspenzije 5 mg paklitaksela. • Druga sestavina je človeški albumin (ki vsebuje natrij, natrijev kaprilat in N- acetil DL triptofanat).
Abraxane is a white to yellow powder for suspension for infusion available in glass vials containing 100 mg paclitaxel.
Zdravilo Abraxane je bel do rumen prašek za suspenzijo za infundiranje v steklenih vialah, ki vsebujejo po 100 mg paklitaksela.
Marketing Authorisation Holder Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ United Kingdom
Imetnik dovoljenja za promet z zdravilom Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ Velika Britanija
Manufacturer Catalent UK Packaging Ltd Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX United Kingdom
Izdelovalec Catalent UK Packaging Ltd Lancaster Way Wingates Industrial Park Westhoughton BL5 3XX Velika Britanija
This leaflet was last approved in {MM/YYYY}
Navodilo je bilo odobreno {MM/ LLLL}
23 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.
If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water.
Če Abraxane pride v stik s sluznico, jo takoj temeljito sperite z vodo.
Reconstitution of the product and administration
Rekonstitucija izdelka in dajanje
Abraxane should be admin istered 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.
Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should be injected into a 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 vialo z zdravilom Abraxane vsaj 1 minuto.
The generation of foam should be avoided.
Nato vialo pazljivo in počasi sučite in/ ali obračajte vsaj dve minuti, dokler se ves prašek popolnoma ne resuspendira Izogibajte se nastanku pene.