natgillin/translations-raw huggingface dataset:
41 • Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina • Changes in blood pressure, faster heart beat, dilation of blood vessels • Fluid retention in the body, fever, discomfort, lethargy and weakness • Inflammation of the liver, yellowing of the skin and whites of the eyes
42 • Bolezni prebavil kot so zaprtje, slaba prebava, napenjanje, kolcanje, vnetje ustne sluznice, požiralnika, želodčne sluznice, sluznice tankega črevesa, jeter ali trebušne slinavke in gastrointestinalne krvavitve. • Krči, povečana mišična napetost, tresenje, mišična šibkost, bolečine v sklepih. • Nespečnost, omotičnost in glavobol, šumenje v ušesu ali otrplost, spremenjen okus, izguba apetita, izguba telesne mase. • Vnetja in okužbe dihalnega in prebavnega trakta, vnetje grla, vnetje sinusov, izcedek iz nosu in srbeč nos. • Rak kože ali nerakasta rast kože in glivične okužbe kože in nožnice. • Spremembe krvnega tlaka, hitrejše bitje srca, razširjenje krvnih žil. • Zadrževanje tekočin v telesu, zvišana telesna temperatura, neugodje, otrplost in šibkost. • Vnetje jeter, porumenelost kože in beločnic.
Uncommon side effects likely to affect less than 1 in 100 but more than 1 in 1000 people • Proliferation of the lymphatic tissue, including malignant tumours • Inflammation or infections of the heart and its valves and of the membrane that covers the brain and spinal cord
Občasni neželeni učinki prizadenejo manj kot 1 od 100, vendar več kot 1 od 1. 000 bolnikov: • Rast limfatičnega tkiva, vključno z malignimi tumorji. • Vnetje ali okužbe srca ter srčnih zaklopk in ovojnice, ki loči možgane od hrbtenjače.
Other side effects that have been reported where frequency has not been established • Hypersensitivity (allergic) reactions
Drugi neželeni učinki, kjer pogostnost ni bila ugotovljena: • Preobčutljivostne (alergične) reakcije.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek med jemanjem zdravila Myfenax, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE MYFENAX
SHRANJEVANJE ZDRAVILA MYFENAX
What Myfenax contains:
Kaj vsebuje zdravilo Myfenax
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) 42 Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
43 Pokrovček: indigotin (E132) titanov dioksid (E171) želatina Telo: rdeči železov oksid (E172) rumeni železov oksid (E172) titanov dioksid (E171) želatina Črnilo vsebuje: šelak, črni železov oksid (E172), propilenglikol in kalijev hidroksid.
Body: caramel opaque, printed ‘ 250 ’ axially in black ink.
Telo: karamelne barve s črnim napisom “ 250” v smeri osi kapsule.
Cap: light blue opaque printed ‘ M ’ axially in black ink.
Pokrovček: svetlo modra s črnim napisom “ M ” v smeri osi kapsule.
Myfenax 250 mg hard capsules are available in PVC/ PVdC – aluminium blisters in pack sizes of 100 or 300 capsules per carton.
Zdravilo Myfenax 250 mg trde kapsule je na voljo v prozornem PVC/ PVdC aluminijastiem pretisnem omotu, v pakiranjih po 100 in 300 kapsul v škatli
It is used in combination with other medicines with a similar function (i. e. ciclosporin and corticosteroids).
Zdravilo Myfenax uporabljamo skupaj z drugimi zdravili s podobnim delovanjem (to so ciklosporin in kortikosteroidi).
other ingredients of Myfenax. if you are breast-feeding.
sestavino zdravila Myfenax;
- if you experience any evidence of infection (e. g. fever, sore throat), unexpected bruising
- če opazite znake okužbe (npr. zvišana telesna temperatura, vneto grlo), nepričakovane
and/ or bleeding
podplutbe in/ ali krvavitve;
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
46 Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic kidney failure to reduce the absorption of phosphate), or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
včasih prejmejo po presaditveni operaciji), holestiramin (uporabljajo ga za zdravljenje bolnikov z visokim holesterolom), rifampicin (antibiotik), antacid, fosfatne vezalce (uporabljajo jih za zmanjšanje absorpcije fosfatov pri bolnikih s kronično ledvično odpovedjo) ali druga zdravila (vključno s tistimi, ki ste jih dobili brez recepta), za katera vaš zdravnik ne ve?
Liver Transplant
47 Presaditev jeter
The recommended daily dose is 6 tablets (3 g of the 45 active ingredient) taken as 2 separate doses.
Priporočeni dnevni odmerek je 6 tablet (3 g zdravilne učinkovine), razdeljenih na 2 posamezna odmerka.
If you take more Myfenax than you should It is important not to take too many tablets.
Če ste vzeli večji odmerek zdravila Myfenax, kot bi smeli:
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people: • Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid • Kidney problems with increased levels of urea • Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding • Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain • Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss • Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose • Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina • Changes in blood pressure, faster heart beat, dilation of blood vessels • Fluid retention in the body, fever, discomfort, lethargy and weakness
Pogosti neželeni učinki prizadenejo manj kot 1 od 10, vendar več kot 1 od 100 bolnikov: • Spremembe različnih laboratorijskihparametrov, vključno z zvišanimi vrednostmi jetrnih encimov, ledvičnimi parametri, kot so kreatinin, kalij, krvni sladkor, lipidi v krvi, holesterol, fosfataze, magnezij, kalcij in sečna kislina. • Težave z ledvicami z zvišanimi vrednostmi sečnine. • Bolezni prebavil kot so zaprtje, slaba prebava, napenjanje, kolcanje, vnetje ustne sluznice, požiralnika, želodčne sluznice, sluznice tankega črevesa, jeter ali trebušne slinavke in gastrointestinalne krvavitve. • Krči, povečana mišična napetost, tresenje, mišična šibkost, bolečine v sklepih. • Nespečnost, omotičnost in glavobol, šumenje v ušesu ali otrplost, spremenjen okus, izguba apetita, izguba telesne mase. • Vnetja in okužbe dihalnega in prebavnega trakta, vnetje grla, vnetje sinusov, izcedek iz nosu in srbeč
46 • Inflammation of the liver, yellowing of the skin and whites of the eyes
48 nos. • Rak kože ali nerakasta rast kože in glivične okužbe kože in nožnice. • Spremembe krvnega tlaka, hitrejše bitje srca, razširjenje krvnih žil. • Zadrževanje tekočin v telesu, zvišana telesna temperatura, neugodje, otrplost in šibkost. • Vnetje jeter, porumenelost kože in beločnic.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek med jemanjem zdravila Myfenax, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
The active substance is 500 mg mycophenolate mofetil.
Vsaka tableta vsebuje 500 mg mofetilmikofenolata.
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Obloga tablete: hipromeloza (E464) titanov dioksid (E171) makrogol smukec indigotin (E132)
Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Temno vijoličaste, filmsko obložene tablete ovalne oblike, z vgraviranim napisom “ M500 ” na eni strani in brez napisa na drugi.
47 Myfenax 500 mg film-coated tablets is available in PVC/ PVdC – aluminium blisters in pack sizes of 50 or 150 tablets per carton.
Zdravilo Myfenax 500 mg filmsko obložene tablete je na voljo v PVC/ PVdC aluminijastem pretisnem omotu, v pakiranjih po 50 in 150 tablet v škatli
Teva Pharmaceuticals Works Private Limited Company H-2100 Gödöll ő, Táncsics Mihály ut 82 Hungary
TEVA Pharmaceutical Works Private Limited Company H- 2100 Gödöllő Táncsics Mihály út 82 Madžarska
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
50 Navodilo je bilo odobreno {MM/ LLLL} Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
Myocet is a powder and solutions to be made up into a solution for infusion (drip into a vein).
Zdravilo Myocet je prašek in raztopina, ki se uporabljata za pripravo raztopine za infundiranje (kapalne infuzije v veno).
Myocet is used with cyclophosphamide (an anticancer medicine) for the treatment of metastatic breast cancer in women. ‘ Metastatic ’ means the cancer that has spread to other parts of the body.
Zdravilo Myocet se uporablja skupaj s ciklofosfamidom (zdravilo proti raku) pri zdravljenju metastaznega raka dojke pri ženskah.
The medicine can only be obtained with a prescription.
„ Metastazni ” pomeni, da se je rak razširil na druge dele telesa.
Myocet should be used in units specialised in giving cytotoxic chemotherapy (cell-killing cancer treatments) under the supervision of a doctor who is qualified in the use of chemotherapy.
Zdravilo Myocet je treba uporabljati v enotah, specializiranih za dajanje citotoksične kemoterapije (zdravljenja z ubijanjem rakastih celic) pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
Myocet needs to be made up before use by mixing the separate components supplied in the pack and using a special heater or a water bath.
Zdravilo Myocet je treba pred uporabo pripraviti z mešanjem ločenih sestavin, dostavljenih v ovojnini, pri tem pa se uporabi posebni grelnik ali vodna kopel.
The recommended starting dose of Myocet is 60 to 75 mg per square metre body surface area (calculated using the patient’ s weight and height).
Priporočeni začetni odmerek zdravila Myocet je od 60 do 75 mg na kvadratni meter telesne površine (izračuna se na podlagi višine in teže bolnika).
It is given every three weeks by infusion into a vein over a period of one hour.
Zdravilo se da vsake tri tedne z infundiranjem v veno, ki traja eno uro.
The patient ’ s liver and bone marrow should be monitored during treatment using blood tests.
Med zdravljenjem je treba s pomočjo krvnih testov nadzorovati jetra in kostni mozeg bolnika.
Treatment should be interrupted or the dose reduced if signs of liver problems or certain other side effects develop.
Če se pojavijo znaki težav z jetri ali nekateri drugi neželeni učinki, je treba zdravljenje prekiniti ali zmanjšati odmerek.
The active substance in Myocet, doxorubicin hydrochloride, is a cytotoxic (cell-killing) medicine that belongs to the group ‘ anthracyclines’.
Zdravilna učinkovina zdravila Myocet, doksorubicinijev klorid, je citotoksično (celice ubijajoče) zdravilo, ki spada v skupino „ antraciklinov ”.
It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Deluje tako, da moti DNA v celicah in jim tako preprečuje ustvarjati nove kopije DNA in proizvajati beljakovine.
This means that cancer cells cannot divide and eventually die.
To pomeni, da se celice raka ne morejo razmnoževati in sčasoma umrejo.
Myocet accumulates in tumours, where its action can be concentrated.
Zdravilo Myocet se nabira v tumorjih, kjer je mogoče koncentrirati njegovo delovanje.
Doxorubicin hydrochloride has been available since the 1960s.
Doksorubicinijev klorid je na voljo od 60. let prejšnjega stoletja.
In Myocet, doxorubicin hydrochloride is contained in microscopic fat particles called ‘ liposomes’.
Doksorubicinijev klorid se v zdravilu Myocet nahaja v mikroskopsko majhnih maščobnih delcih, imenovanih liposomi.
Reproduction is authorised provided the source is acknowledged. combination with cyclophosphamide, in 297 women.
V prvi študiji so zdravilo Myocet primerjali s standardnim (neliposomskim) doksorubicinom, obe zdravili pa so dajali v kombinaciji s ciklofosfamidom pri 297 ženskah.
In the second study, Myocet alone was compared with standard doxorubicin alone in 224 women.
V drugi študiji so zdravilo Myocet kot samostojno zdravilo primerjali s standardnim doksorubicinom kot samostojnim zdravilom pri 224 ženskah.
The third study compared the effects of Myocet with epirubicin (another anthracycline anticancer medicine), both in combination with cyclophosphamide in 160 women.
V tretji študiji so pri 160 ženskah primerjali učinke zdravila Myocet z učinki epirubicina (drugo antraciklinsko zdravilo proti raku), obe zdravili pa so dajali skupaj s ciklofosfamidom.
In all three studies, the main measure of effectiveness was the proportion of patients who had responded to treatment after six weeks.
V vseh treh študijah je bilo glavno merilo učinkovitosti delež bolnikov, ki so se po šestih tednih odzvali na zdravljenje.
What benefit has Myocet shown during the studies?
Kakšne koristi je zdravilo Myocet izkazalo med raziskavami?
Myocet was as effective as the comparator medicines in all three studies.
Zdravilo Myocet je bilo enako učinkovito kot primerjalna zdravila v vseh treh študijah.
In the first study, 43% of the patients receiving Myocet or standard doxorubicin in combination with cyclophosphamide responded to treatment, while in the study of Myocet or standard doxorubicin alone, 26% of each group responded.
V prvi študiji se je na zdravljenje odzvalo 43% bolnikov, ki so prejemali zdravilo Myocet ali standardni doksorubicin v kombinaciji s ciklofosfamidom, pri študiji zdravila Myocet ali standardnega doksorubicina kot samostojnih zdravil pa se je odzvalo 26% bolnikov iz vsake skupine.
In the third study, 46% of the patients taking Myocet in combination with cyclophosphamide responded to treatment, compared with 39% of those receiving epirubicin in combination with cyclophosphamide.
V tretji študiji se je na zdravljenje odzvalo 46% bolnikov, ki so prejemali zdravilo Myocet v kombinaciji s ciklofosfamidom, medtem ko je bil ta delež pri bolnikih, ki so prejemali epirubicin v kombinaciji s ciklofosfamidom, 39%.
Patients receiving Myocet were less likely to experience heart problems than those receiving standard doxorubicin.
Pri bolnikih, ki so prejemali Myocet, je bila verjetnost težav s srcem manjša kot pri tistih, ki so prejemali standardni doksorubicin.
The most common side effects with Myocet (seen in more than 1 patient in 10) are infection, neutropenic fever (fever associated with low white blood cell counts), neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), nausea (feeling sick) or vomiting, stomatitis (inflammation of the lining of the mouth) or mucositis (inflammation of the mouth and throat), diarrhoea, alopecia (hair loss), skin effects such as rash and dry skin, and fatigue, malaise (feeling unwell) or asthenia (weakness).
Najpogostejši neželeni učinki zdravila Myocet (opaženi pri več kot 1 bolniku od 10) so okužba, nevtropenična vročina (vročina, ki je povezana z majhnim številom belih krvnih celic), nevtropenija (majhno število belih krvnih celic), trombocitopenija (majhno število krvnih ploščic), anemija (majhno število rdečih krvnih celic), navzeja (občutek slabosti) ali bruhanje, stomatitis (vnetje ustne sluznice) ali mukozitis (vnetje ust in grla), driska, alopecija (izguba las), učinki na koži, kakršna sta izpuščaj in suha koža, utrujenost, oslabelost (slabo počutje) ali astenija (šibkost).
For the full list of all side effects reported with Myocet, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Myocet, glejte Navodilo za uporabo.
Myocet should not be used in people who may be hypersensitive (allergic) to doxorubicin or any of the other ingredients.
Zdravila Myocet ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) doksorubicin ali katerokoli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) noted that Myocet has a lower risk of heart problems than conventional doxorubicin, while both medicines have similar levels of effectiveness.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je tveganje za pojav težav s srcem nižje pri uporabi zdravila Myocet kot pri uporabi konvencionalnega doksorubicina, obe zdravili pa sta približno enako učinkoviti.
Therefore, the Committee decided that Myocet’ s benefits are greater than its risks, in combination with cyclophosphamide, for the first-line treatment of metastatic breast cancer in women.
Zaradi tega je Odbor odločil, da so korisi zdravila Myocet v kombinaciji s ciklofosfamidom za zdravljenje metastaznega raka dojke pri ženskah kot zdravilo prve izbire večje od z njim povezanih tveganj.
The Committee recommended that Myocet be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Myocet.
The marketing authorisation was renewed on 13 July 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 13. julija 2005.
The marketing authorisation holder is Cephalon Europe.
Imetnik dovoljenja za promet je družba Cephalon Europe.
The full EPAR for Myocet can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Myocet je na voljo tukaj.
EU Number
Številka postopka EMEA
Invented name
Zaščiteno ime ime
Powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Prašek in že pripravljene mešanice za koncentrat za
Vial (glass) + Vial (glass)
Prašek: ampula (steklena) Že pripravljene mešanice:
2 sets of 3 vials
2 kompleta s 3 ampulami
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Myocet 50 mg prašek in dodatki za koncentrat za liposomsko disperzijo za infundiranje
Liposome– encapsulated doxorubicin– citrate complex corresponding to 50 mg doxorubicin HCl.
Kompleks doksorubicina in citrata, enkapsuliran v liposome, ki ustreza 50 mg doksorubicinijevega klorida.
Powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Prašek in dodatki za koncentrat za liposomsko disperzijo za infundiranje
Myocet is supplied as a three-vial system:
Myocet je na voljo v obliki treh vial:
Myocet doxorubicin HCl (a red lyophilised powder), Myocet liposomes (a white to off-white, opaque and homogeneous solution), Myocet buffer (a clear colourless solution).
Myocet doksorubicinijev klorid (rdeč liofiliziran prašek), liposomi Myocet (bela ali sivo bela, neprozorna in homogena raztopina), pufer Myocet (bistra, brezbarvna raztopina).
Myocet, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in women.
Myocet je v kombinaciji s ciklofosfamidom indiciran kot zdravilo prvega izbora pri zdravljenju metastaznega raka dojke pri ženskah.
The use of Myocet should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy.
Uporaba Myoceta mora biti omejena na enote, specializirane za dajanje citotoksične kemoterapije, in dajati se ga sme le pod nadzorom zdravnika, izkušenega v uporabi kemoterapije.
Dosage When Myocet is administered in combination with cyclophosphamide (600 mg/ m2) the initial recommended dose of Myocet is 60-75 mg/ m2 every three weeks.
Odmerjanje Pri uporabi v kombinaciji s ciklofosfamidom (600 mg/ m2) je začetni priporočeni odmerek Myoceta 60- 75 mg/ m2 vsake tri tedne.
Administration Myocet must be reconstituted and further diluted prior to administration (see section 6.6).
Uporaba Myocet morate pred uporabo rekonstituirati in razredčiti (glejte poglavje 6. 6).
A final concentration of between 0.4 to 1.2 mg/ ml doxorubicin HCl, is required.
Končna koncentracija mora biti med 0, 4 in 1, 2 mg/ ml doksorubicinijevega klorida.
Myocet is administered by intravenous infusion over a period of 1 hour.
Infundiranje traja 1 uro.
Myocet must not be administered by the intramuscular or subcutaneous route or as a bolus injection.
Myocet se ne sme dajati po intramuskularni ali subkutani poti ali v obliki bolusne injekcije.
Paediatric patients The safety and efficacy of Myocet has not yet been established in paediatric patients (below 18 years of age).
Pediatrične bolnice Varnosti in učinkovitosti Myoceta pri pediatričnih bolnicah (mlajših od 18 let) še niso ocenili.
Elderly patients Safety and efficacy of Myocet have been assessed in 61 patients with metastatic breast cancer, age 65 and over.
Starejše bolnice Varnost in učinkovitost Myoceta so ocenjevali pri 61 bolnicah z metastaznim rakom dojke, starih 65 let ali več.
Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet in this population was comparable to that observed in patients less than 65 years old.
Podatki iz randomiziranega kontroliranega kliničnega preskušanja kažejo, da sta učinkovitost Myoceta in njegova varnost za srce v tej populaciji primerljivi s tistima pri bolnicah, mlajših od 65 let.
Use in patients with impaired hepatic function As metabolism and excretion of doxorubicin occurs primarily by the hepatobiliary route, evaluation of hepatobiliary function should be performed before and during therapy with Myocet.
Presnova in izločanje doksorubicina potekata predvsem po hepatobiliarni poti, zato morate pred zdravljenjem z Myocetom in med njim oceniti hepatobiliarno delovanje.
2 Based on limited data in patients with liver metastases, it is recommended that the initial dose of Myocet is reduced in accordance with the following table
2 Glede na omejene podatke pri bolnicah z metastazo jeter se priporoča, da se začetni odmerek Myoceta zmanjša v skladu s spodnjo preglednico
Bilirubin < ULN and normal AST Bilirubin< ULN and raised AST Bilirubin> ULN but< 50 μmol/l Bilirubin > 50 μmol/l
Bulirubin > ULN toda < 50 μmol/ l Bilirubin > 50 μmol/ l
Standard dose of 60 - 75mg/ m2 Consider a 25% dose reduction 50% dose reduction 75% dose reduction
50% zmanjšanje odmerka 75% zmanjšanje odmerka
If possible, Myocet should be avoided in patients with bilirubin > 50 μ mol/ l as the recommendation is based mainly on extrapolations.
Če je mogoče, Myoceta ne uporabljajte pri bolnicah z bilirubinom > 50 μmol/ l saj je priporočilo narajeno v glavnem na ekstrapolacijah.
For dose reductions due to other toxicity, see section 4.4.
Za informacije o zmanjšanju odmerka zaradi drugih toksičnosti glejte poglavje 4. 4.
Use in patients with impaired renal function Doxorubicin is metabolised largely by the liver and excreted in the bile.
Doksorubicin se presnavlja predvsem v jetrih in izloča v žolču.
Hypersensitivity to the active substance, to the pre-admixtures or to any of the excipients.
Preobčutljivost za zdravilno učinkovino, dodatke ali katerokoli pomožno snov.
Myelosuppression Therapy with Myocet causes myelosuppression.
Mielosupresija Zdravljenje z Myocetom povzroča mielosupresijo.
Myocet should not be administered to individuals with absolute neutrophil counts (ANC) lower than 1,500 cells/μ l or platelets less than 100,000/μ l prior to the next cycle.
Myoceta se ne sme dajati osebam, ki imajo pred naslednjim krogom zdravljenja absolutno število nevtrofilcev (ANC – » absolute neutrophil counts «) manjše od 1500 celic/ μl ali število krvnih ploščic manjše od 100. 000/ μl.