natgillin/translations-raw huggingface dataset:
Careful haematological monitoring (including white blood cell and platelet count, and haemoglobin) should be performed during therapy with Myocet.
Med zdravljenjem z Myocetom je treba izvajati strog hematološki nadzor (vključno s štetjem belih krvnih celic in krvnih ploščic ter spremljanjem ravni hemoglobina).
The following dosage modifications are recommended during therapy and should be performed in parallel for both Myocet and cyclophosphamide.
Upoštevajte jih vzporedno za Myocet in ciklofosfamid.
Haematological Toxicity Grade
Hematološka toksičnost Sprememba Stopnja
Nadir ANC (cells/μ l)
Najnižje število ANC (celic/ μl)
Nadir Platelet Count (cells/μ l)
Najnižje število krvnih ploščic (celic/ μl)
1500 – 1900 1000 – Less than 1500 500 – 999
1. 500– 1. 900 1. 000– manj kot 1. 500 500– 999
75,000 – 150,000 50,000 – Less than 75,000 25,000 – Less than 50,000
75. 000– 150. 000 50. 000– manj kot 75. 000 25. 000– manj kot 50. 000
None None Wait until ANC 1500 or more and/ or platelets 100,000 or more then redose at 25% dose reduction
brez spremembe brez spremembe Počakajte, da bo ANC 1. 500 ali več in/ ali število krvnih ploščic 100. 000 ali več in nato nadaljujte zdravljenje s 25% manjšim odmerkom
Less than 25,000
manj kot 25. 000
Wait until ANC 1500 and/ or platelets 100,000 or more then redose at 50% dose reduction
Počakajte, da bo ANC 1. 500 ali več in/ ali število krvnih ploščic 100. 000 ali več in nato nadaljujte zdravljenje s 50% manjšim odmerkom
3 Mucositis Grade
3 Mukozitis Stopnja
None
brez spremembe
Wait one week and if the symptoms improve redose at 100% dose
Počakajte en teden, in če se znaki izboljšajo, nadaljujte zdravljenje s 100% odmerkom
Wait one week and if symptoms improve redose at 25% dose reduction
Počakajte en teden, in če se znaki izboljšajo, nadaljujte zdravljenje s 25% manjšim odmerkom
Wait one week and if symptoms improve redose at 50% dose reduction
Počakajte en teden, in če se znaki izboljšajo, nadaljujte zdravljenje s 50% manjšim odmerkom
For dose reduction of Myocet due to liver function impairment, see section 4.2.
Za zmanjšanje odmerkov Myoceta zaradi okvare delovanja ledvic glejte poglavje 4. 2.
Cardiac toxicity Doxorubicin and other anthracyclines can cause cardiotoxicity.
Srčna toksičnost Doksorubicin in drugi antraciklini lahko povzročijo kardiotoksičnost.
Analyses of cardiotoxicity in clinical trials have shown a statistically significant reduction in cardiac events in patients treated with Myocet compared to patients treated with conventional doxorubicin at the same dose in mg.
Analize kardiotoksičnosti v kliničnih preskušanjih so pokazale značilno zmanjšanje učinkov na srce pri bolnicah, ki so jih zdravili z Myocetom, v primerjavi s tistimi, ki so jih zdravili z navadnim doksorubicinom pri enakih odmerkih v mg.
The full clinical relevance of these findings is currently unclear.
Celoten klinični pomen teh rezultatov še ni povsem znan.
In a phase III study in combination with cyclophosphamide (CPA) comparing Myocet (60 mg/ m2) + CPA (600 mg/ m2) versus doxorubicin (60 mg/ m2) + CPA (600 mg/ m2), 6% versus 21% of patients, respectively, developed a significant decrease in left ventricular ejection fraction (LVEF).
Pri kombinaciji Myoceta in CPA se je pri 6% bolnic, pri kombinaciji doksorubicina in CPA pa pri 21% bolnic značilno zmanjšal iztisni delež levega prekata (LVEF – » left ventricular ejection fraction «).
In a phase III study comparing single-agent Myocet (75 mg/ m2) versus single-agent doxorubicin (75 mg/ m2), 12% versus 27% of patients, respectively developed a significant decrease in LVEF.
Pri uporabi Myoceta se je pri 12%, pri uporabi doksorubicina pa pri 27% bolnic značilno zmanjšal LVEF.
The corresponding figures for congestive heart failure (CHF), which was less accurately assessed, were 0% for Myocet + CPA versus 3% for doxorubicin + CPA, and 2% for Myocet versus 8% for doxorubicin.
Rezultati za kongestivno srčno odpoved (CHF – » Congestive Heart Failure «), ki so jo ocenjevali manj natančno, so bili 0% za kombinacijo Myoceta in CPA, 3% za kombinacijo doksorubicina in CPA ter 2% za Myocet in 8% za doksorubicin.
The median lifetime cumulative dose of Myocet in combination with CPA to a cardiac event was > 1260 mg/ m2, compared to 480 mg/ m2 for doxorubicin combination with CPA.
Mediana kumulativnega odmerka Myoceta v kombinaciji s CPA, ki je pripeljala do srčnega bolezenskega znaka, je bila > 1260 mg/ m2, v primerjavi s 480 mg/ m2 za doksorubicin v kombinaciji s CPA.
There is no experience with Myocet in patients with a history of cardiovascular disease, e. g. myocardial infarction within 6 months prior to treatment.
Ni izkušenj z uporabo Myoceta pri bolnicah, ki so imele v zadnjih 6 mesecih pred zdravljenjem kardiovaskularno bolezen, npr. miokardni infarkt.
The cardiac function of the patients treated concomitantly with Myocet and trastuzumab must be appropriately monitored as described below.
Delovanje srca bolnic, sočasno zdravljenih z zdravilom Myocet in trastuzumabom je treba ustrezno nadzirati kot je opisano spodaj.
The total dose of Myocet should also take into account any previous, or concomitant, therapy with other cardiotoxic compounds, including anthracyclines and anthraquinones.
Pri skupnem odmerku Myoceta upoštevati tudi preteklo ali sočasno zdravljenje z drugimi kardiotoksičnimi spojinami, vključno z antraciklini in antrakinoni.
Before initiation of Myocet therapy a measurement of left ventricular ejection fraction (LVEF) is routinely recommended, either by Multiple Gated Arteriography (MUGA) or by echocardiography.
Pred začetkom zdravljenja z Myocetom je priporočena rutinska meritev iztisnega deleža levega prekata (LVEF), bodisi z večvhodno arteriografijo (MUGA – » Multiple Gated Arteriography «) ali z ehokardiografijo.
These methods should also be applied routinely during Myocet treatment.
Te preiskave morate rutinsko izvajati tudi med zdravljenjem z Myocetom.
The evaluation of left ventricular function is considered mandatory before each additional administration of Myocet once a patient exceeds a lifetime cumulative anthracycline dose of 550 mg/ m2 or whenever cardiomyopathy is suspected.
Ko bolnica preseže skupni kumulativni odmerek antraciklina 550 mg/ m2 ali če obstaja sum na kardiomiopatijo, je pred vsakim dajanjem Myoceta nujna ocena delovanja levega prekata.
If LVEF has decreased substantially from baseline e. g. by > 20 points to a final value > 50% or by > 10 points to a final value of < 50%, the benefit of continued therapy must be carefully evaluated against the risk of producing irreversible cardiac damage.
Če se vrednost LVEF znatno zmanjša od osnovne vrednosti, npr. za > 20 točk na končno vrednost > 50% ali za > 10 točk na končno vrednost < 50%, morate previdno oceniti koristi nadaljevanja zdravljenja v primerjavi z tveganjem za nastanek trajnih srčnih okvar.
However, the most definitive test for anthracycline myocardial injury, i. e., endomyocardial biopsy, should be considered.
Pretehtati je treba tudi uporabo najbolj dokončne preiskave antraciklinske poškodbe miokarda, to je endomiokardne biopsije.
All patients receiving Myocet should also routinely undergo ECG monitoring.
4 Vse bolnice, ki prejemajo Myocet, morate rutinsko pregledovati tudi z EKG.
Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the cessation of Myocet therapy.
Prehodne spremembe EKG, kot so izravnavanje vala T, depresija segmenta S- T in benigne aritmije, niso nujne indikacije za prekinitev zdravljenja z Myocetom.
Congestive heart failure due to cardiomyopathy may occur suddenly, and may also be encountered after discontinuation of therapy.
Do kongestivne srčne odpovedi kot posledice kardiomiopatije lahko pride nenadoma in tudi po prekinitvi zdravljenja.
4 Injection site reactions Myocet should be considered an irritant and precautions should be taken to avoid extravasation.
Reakcije na mestu injiciranja Myocet je dražljivec zato morate biti previdni, da preprečite ekstravazacijo.
Subsequently, the Myocet infusion should be restarted in a different vein than that in which the extravasation has occurred.
Zatem Myocet infundirajte naprej, vendar ne v veno, pri kateri je prišlo do ekstravazacije.
Note that Myocet may be administered through a central or peripheral vein.
Ne pozabite, da Myocet lahko daste v osrednjo ali v periferno veno.
In the clinical program, there were nine cases of accidental extravasation of Myocet, none of which were associated with severe skin damage, ulceration or necrosis.
Nobeden od njih ni bil povezan s hudimi poškodbami kože, nastankom razjed ali nekrozo.
Infusion associated reactions When infused rapidly acute reactions associated with liposomal infusions have been reported.
Reakcije, povezane z infundiranjem Pri hitrem infundiranju so poročali o akutnih reakcijah, povezanih z liposomskimi infuzijami.
Reported symptoms have included flushing, dyspnoea, fever, facial swelling, headache, back pain, chills, tightness in the chest and throat, and/ or hypotension.
Med simptomi, o katerih so poročali, so bili rdečica, dispneja, povišana telesna temperatura, zatekanje obraza, glavobol, bolečine v hrbtu, mrzlica, tiščanje v prsih in grlu in/ ali hipotenzija.
Other For precautions regarding the use of Myocet with other medicinal products, see section 4.5.
Drugo Za previdnostne ukrepe pri uporabi Myoceta z drugimi zdravili glejte poglavje 4. 5.
Efficacy and safety of Myocet in the adjuvant treatment of breast cancer have not been determined.
Učinkovitosti in varnosti Myoceta pri pomožnem zdravljenju raka dojke niso določili.
The importance of apparent differences in tissue distribution between Myocet and conventional doxorubicin has not been elucidated with respect to long-term antitumour efficacy.
Pomena očitnih razlik v porazdelitvi Myoceta in običajnega doksorubicina v tkivih v smislu dolgoročne učinkovitosti proti tumorjem niso razložili.
Specific drug compatibility studies have not been performed with Myocet.
Z Myocetom niso opravili specifičnih študij o združljivosti zdravil.
Myocet is likely to interact with substances that are known to interact with conventional doxorubicin.
Myocet bo verjetno medsebojno deloval s snovmi, za katere je znano, da medsebojno delujejo z običajnim doksorubicinom.
Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit P-glycoprotein (P-Gp).
Koncentracije doksorubicina in njegovega presnovka doksorubicinola v plazmi se lahko povišajo, kadar doksorubicin dajemo skupaj s ciklosporinom, verapamilom, paklitakselom ali drugo učinkovino, ki zavira P- glikoprotein (P- Gp).
Studies of the effect of Myocet on other substances are also lacking.
Študij o učinku Myoceta na druge snovi tudi ni.
Concomitant treatment with other substances reported to be cardiotoxic or with cardiologically active substances (e. g. calcium antagonists) may increase the risk for cardiotoxicity.
Sočasna uporaba z drugimi kardiotoksičnimi ali kardiološko aktivnimi snovmi (npr. antagonisti kalcija) lahko poveča tveganje kardiotoksičnosti.
Concomitant therapy with other liposomal or lipid-complexed substances or intravenous fat emulsions could change the pharmacokinetic profile of Myocet.
Sočasna uporaba z drugimi liposomskimi snovmi ali lipidnimi kompleksi ali intravenozna uporaba maščobnih emulzij lahko spremeni farmakokinetični profil Myoceta.
Due to the known cytotoxic, mutagenic and embryotoxic properties of doxorubicin, Myocet should not be used during pregnancy unless clearly necessary.
Zaradi znanih citotoksičnih, mutagenih in embriotoksičnih lastnosti doksorubicina Myoceta ne smete uporabljati med nosečnostjo, razen če je nujno.
Women of childbearing potential should use an effective contraceptive during treatment with Myocet and up to 6 months following discontinuation of therapy.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 6 mesecev po njem.
Women receiving Myocet should not breastfeed.
Ženske, ki prejemajo Myocet, ne smejo dojiti.
4.7 Effect on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Myocet has been reported to cause dizziness.
Poročali so, da Myocet povzroča vrtoglavico.
Patients who suffer from this should avoid driving and operating machinery.
Bolnice, ki imajo vrtoglavico, se morajo izogibati vožnji in upravljanju s stroji.
Clinical Program
Klinični program
Adverse drug reactions (ADR) data obtained from 323 patients with metastatic breast cancer in three randomised phase III trials of Myocet as a single agent and in combination with Cyclophosphamide (CPA) have been provided in Table 1 as pooled data.
Podatki o neželenih škodljivih posledicah zdravila (ADR), dobljeni pri 323 bolnicah z metastaznim rakom dojke v treh randomiziranih poskusih v III. stadiju bolezni z Myocetom, uporabljenim kot samostojno zdravilo ali v kombinaciji s ciklofosfamidom (CPA), so prikazani v Preglednici 1 kot skupnni podatki.
Treatment cycles were every three weeks in each trial and G-CSF was used in 38-56% of the cycles.
Krogi zdravljenja so potekali v vsakem preskusu vsake tri tedne, G- CSF pa je bil uporabljen v 38- 56% vseh krogov.
5 Table 1:
Preglednica 1:
Adverse reactions from pooled study results of three randomised Phase III clinical trials of Myocet as a single agent and in combination with Cyclophosphamide (CPA).
Neželeni učinki, vidni iz rezultatov skupne raziskave treh randomiziranih kliničnih poskusov z Myocetom v III. stadiju bolezni, uporabljenim kot samostojno zdravilo ali v kombinaciji s ciklofosfamidom (CPA) (št. =323)
(n=323)
Neželeni učinki1, 2
System Organ Class
Skupina organskega sistema
Frequency (as percentage)
Pogostnost (kot odstotek)
Adverse Reactions1,2
Okužbe (infekcije) in parazitske
Infections and Infestations
bolezni (infestacije)
Infection (All Grades) (Grade ≥ 3) Neutropenic Fever3
(vse stopnje) (stopnja ≥3)
Blood and Lymphatic System
Neutropenična vročica3
11 9
11
ANC< 500 & fever > 38˚C 3,4 ANC> 500 & fever > 38˚ C 3,4 Neutropenia
ANC > 500 & pov. tel. temperatura > 38˚C 3, 4
Disorders
Bolezni krvi in limfatičnega
< 2000/ µl < 500/ µl < 500/ µl for ≥ 7 days Thrombocytopenia
< 2000/ µl < 500/ µl < 500/ µl za ≥ 7 dni Trombocitopenia
< 100,000/ µl < 20,000/ µl Anaemia
< 100, 000/ µl < 20, 000/ µl Anemia
< 11 g/ dl < 8 g/ dl Nausea/ Vomiting (All Grades) (Grade ≥ 3) Stomatitis/ Mucositis
< 11 g/ dl < 8 g/ dl Slabost/ Bruhanje (vse stpopnje) (stopnja≥3) Stomatitis/ Mukozitis
(All Grades) (Grade ≥ 3) Diarrhoea
(vse stopnje) (stopnja ≥3) Diareja
(All Grades) (Grade ≥ 3)
(vse stopnje) (stopnja ≥3)
Skin and Subcutaneous Tissue
Bolezni kože in podkožnih tkiv
Alopecia - Pronounced
Alopecia - izrazita
Skin Related Toxicities (e. g. rash, dry skin)
S kožo povezane zastrupitve (e. g. izpuščaj, suha koža)
Administration Site Conditions
Splošne težave in težave na mestu dajanja zdravila
(All Grades) (Grade ≥ 3) Injection Site Toxicity
Utrujenost/ Oslabelost/ Asteni a (vse stopnje) (stopnja ≥3) Toksičnost na mestu injiciranja
Incidence of the adverse reaction considered at least possibly related by the investigator, from pooled clinical trials involving 323 patients taking the medicinal product.
Pogostost neželenih učinkov, za katere izvajalec raziskave meni, da so verjetno povezani, v skupnih kliničnih raziskavah, ki zajemajo 323 bolnic, ki jemljejo zdravilo.
2 all adverse reactions have been ranked by frequency within each system organ class.
2 Vsi neželeni učinki so bili razvrščeni po pogostosti v vsaki skupini organskega sistema.
3 with IV antibiotics and/ or hospitalisation 4 absolute neutrophil counts (ANC)
3 z IV antibiotiki in/ ali hospitalizacijo 4 absolutno število nevtrofilcev( ANC)
The following clinically relevant grade 3/ 4 adverse reactions with an incidence of < 5% were also observed from clinical trials involving 948 patients with solid tumours.
Opažene so bile tudi naslednje klinično pomembne neželene reakcije 3- 4 stopnje s < 5% pogostostjo v kliničnih poskusih, v katerih je sodelovalo 948 bolnic s solidnimi tumorji.
AIDS patients with Kaposi’ s sarcoma were not included.
Bolnice z AIDS- om, povezanim s Kaposijevim sarkomom, so bile izključene.
Incidence of less than 5% (Grade 3 or 4, possibly, probably, or definitely related):
Pogostost manj kot 5% (3. ali 4. stopnje, morda, verjetno ali gotovo povezana):
6 Infections and Infestations: fever, Herpes Zoster, injection site infection, sepsis
Okužbe in parazitske bolezni: povišana telesna temperatura, herpes zoster, okužba na mestu injiciranja, sepsa
Blood and Lymphatic System Disorders: leukopenia, lymphopenia, neutropenic sepsis, purpura
Bolezni krvi in limfatičnega sistema: levkopenija, limfopenija, nevtropenična sepsa, purpura
Metabolism and Nutrition Disorders: anorexia, dehydration, hypokalaemia, hyperglycaemia
Presnovne in prehranske motnje: anoreksija, dehidracija, hipokaliemija, hiperglikemija
Psychiatric Disorders: agitation
Psihiatrične motnje: agitacija
Nervous System Disorders: abnormal gait, dysphonia, insomnia, somnolence
Motnje živčnega sistema: motnje pri hoji, disfonija, nespečnost, zaspanost
Cardiac Disorders: arrhythmia, cardiomyopathy, congestive cardiac failure, pericardial effusion
Srčne bolezni: aritmija, kardiomiopatija, kongestivna odpoved srca, perikardni izlivi
Vascular Disorders: hot flushes, hypotension
Žilne bolezni: vročinski oblivi, hipotenzija
Respiratory, Thoracic and Mediastinal Disorders: chest pain, dyspnoea, epistaxis, haemoptysis, pharyngitis, pleural effusion, pneumonitis
Bolezni dihal, prsnega koša in mediastinalnega prostora: bolečine v prsih, dispneja, krvavitve iz nosu, hemoptiza, faringitis, plevralni izliv, pnevmonitis
Gastrointestinal Disorders: constipation, gastric ulcer, oesophagitis
Prebavne motnje: zaprtje, razjeda želodca, ezofagitis
Hepato-Biliary Disorders: increased hepatic transaminases, increased alkaline phosphatase, increased serum bilirubin, jaundice
Hepatobiliarne motnje: povišanje jetrnih transaminaz, povišanje alkalne fosfataze, povišanje serumskega bilirubina, zlatenica
Musculoskeletal, Connective Tissue and Bone Disorders: back pain, muscle weakness, myalgia
Mišičnoskeletne spremembe, spremembe vezivnega tkiva in kosti: bolečine v hrbtu, šibkost mišic, bolečine v mišicah
Skin and Subcutaneous Tissue Disorders: folliculitis, nail disorder, pruritus,
Bolezni kože in podkožja: folikulitis, bolezni nohtov, pruritus,
Renal and Urinary Disorders: haemorrhagic cystitis, oliguria
Bolezni ledvic in sečil: hemoragični cistitis, oligurija
General Disorders and Administration Site Conditions: dizziness, headache, injection site reaction, pain, rigors, weight loss
Splošne težave in težave na mestu dajanja zdravila: vrtoglavica, glavobol, reakcija na mestu injiciranja, bolečina, otrplost, hujšanje
Post-Marketing
Po odobritvi za promet
Relevant adverse reactions obtained from post marketing surveillance have been tabulated in Table 2.
V Preglednici 2 so navedeni relevantni neželeni učinki pridobljeni po odobritvi za promet.
Table 2:
7 Preglednica 2:
Adverse reactions obtained from post-marketing surveillance (4.5 years data).
Neželeni učinki pridobljeni iz nadzora po odobritvi za promet (podatki 4- 5 let).
System Organ Class
Neželeni učinki Skupina organskega sistema
Blood and Lymphatic System Disorders
Bolezni krvi in limfatičnega sistema.
Pancytopenia
Pancitopenia
Acute overdose with Myocet will worsen toxic side effects.
Akutno preveliko odmerjanje Myoceta poslabša toksične neželene učinke.
Treatment of acute overdose should focus on supportive care for expected toxicity and may include hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
Morda bodo potrebni hospitalizacija, zdravljenje z antibiotiki, transfuzija krvnih ploščic in granulocitov ter simptomatsko zdravljenje mukozitisa.
Cytotoxic agents (anthracyclines and related substances), ATC code:
Farmakoterapevtska skupina: citotoksične učinkovine (antraciklinski antibiotiki in sorodne učinkovine), Oznaka ATC:
7 The active substance in Myocet is doxorubicin HCl.
Zdravilna učinkovina v Myocetu je doksorubicinijev klorid.
Doxorubicin may exert its antitumour and toxic effects by a number of mechanisms including inhibition of topoisomerase II, intercalation with DNA and RNA polymerases, free radical formation and membrane binding.
Protitumorski in toksični učinki doksorubicina se lahko kažejo na številne načine, vključno z zaviranjem delovanja topoizomeraze II, interkalacijo z DNK - in RNK- polimerazo, tvorbo prostih radikalov in vezavo na membrane.
Liposomal-encapsulated compared with conventional doxorubicin was not found more active in doxorubicin resistant cell lines in vitro.
Doksorubicin, enkapsuliran v liposome, ni bil učinkovitejši od običajnega doksorubicina pri celičnih linijah, odpornih na doksorubicin in vitro.
In animals, liposome-encapsulated doxorubicin reduced the distribution to heart and gastrointestinal mucosa compared with conventional doxorubicin, while antitumoural efficacy in experimental tumours was maintained.
Pri živalih se je doksorubicin, enkapsuliran v liposome, v manjši meri porazdelil v srce in sluznico prebavil kot običajni doksorubicin, medtem ko se je protitumorski učinek na eksperimentalne tumorje ohranil.
Myocet (60 mg/ m2) + CPA (600 mg/ m2) was compared with conventional doxorubicin + CPA (at the same doses) and Myocet (75 mg/ m2) + CPA (600 mg/ m2) was compared to epirubicin + CPA (at the same doses).
Primerjali so kombinacijo Myoceta (60 mg/ m2) in CPA (600 mg/ m2) s kombinacijo običajnega doksorubicina in CPA (v istih odmerkih) ter kombinacijo Myoceta (75 mg/ m2) in CPA (600 mg/ m2) s kombinacijo epirubicina in CPA (v istih odmerkih).
In a third trial, Myocet (75 mg/ m2) monotherapy was compared with conventional doxorubicin monotherapy (at the same dose).
V tretjem preskušanju so samostojno zdravljenje z Myocetom (75 mg/ m2) primerjali s samostojnim zdravljenjem z običajnim doksorubicinom (v istem odmerku).
Findings regarding response rate and progression-free survival are provided in Table 3.
Rezultati stopnje odzivnosti in časa preživetja brez napredovanja bolezni so prikazani v tabeli 3.
Table 3 Antitumour efficacy summary for combination and single-agent studies
8 Tabela 3 Povzetek protitumorskega učinka pri študijah kombiniranega in samostojnega zdravljenja
Myocet/ CPA Dox 60/ CPA Myocet/ CPA (60/ 600 (60/ 600 (75/ 600
Myocet/ CPA Doks 60/ CPA Myocet/ CPA Epi/ CPA Myocet
Epi/ CPA (75/ 600
(60/ 600 mg/ m (60/ 600 (75/ 600 mg/ m (75/ 600 mg/ m (75 mg/ m2) (75 mg/ m2) 2
Myocet (75 mg/ m2) (75
mg/ m
Dox mg/ m2)
2
mg/ m2) mg/ m2) mg/ m2) mg/ m2)
)
(n=108)
(n = 108)
(n=116)
(n = 116)
(n=142)
(n = 142)
(n=155)
(n = 155)
Tumour response rate Relative Risk
Stopnja odzivnosti tumorja
(95% C. I.)
95%)
Median PFS (months)a Risk Ratio
Mediana PFS (meseci) a
PFS, progression-free survival; Dox, doxorubicin; Epi, epirubicin; Relative Risk, comparator taken as reference; Risk Ratio, Myocet taken as reference a Secondary endpoint
PFS (» progression free survival «) – čas preživetja brez napredovanja bolezni; Doks - doksorubicin; Epi - epirubicin; relativno tveganje - primerjana snov kot referenca; razmerje tveganja - Myocet kot referenca. a Sekundarna končna točka
The plasma pharmacokinetics for total doxorubicin in patients receiving Myocet shows a high degree of inter-patient variability.
Pri plazemski farmakokinetiki skupnega doksorubicina pri bolnicah, ki so prejemale Myocet, prihaja med bolnicami do velikih razlik.
In general however, the plasma levels of total doxorubicin are substantially higher with Myocet than with conventional doxorubicin, while the data indicate that peak plasma levels of free (not liposome-encapsulated) doxorubicin are lower with Myocet than with conventional doxorubicin.
Vendar so v splošnem koncentracije skupnega doksorubicina v plazmi bistveno višje pri Myocetu kot pri običajnem doksorubicinu, medtem ko podatki kažejo, da so najvišje plazemske koncentracije prostega doksorubicina (ne enkapsuliranega v liposome) nižje pri Myocetu kot pri običajnem doksorubicinu.