natgillin/translations-raw huggingface dataset:
Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding.
Anemija (zmanjšanje števila eritrocitov) lahko povzroči utrujenost, zmanjšano število trombocitov v krvi pa lahko poveča nevarnost za krvavitve.
If the drip stings or hurts while you are receiving a dose of Caelyx, tell your doctor immediately.
Če vam infuzija povzroča pekoč občutek ali bolečino, ko prejemate odmerek zdravila Caelyx, to nemudoma povejte zdravniku.
Haematological toxicity may require dose reduction or suspension or delay of therapy.
Zaradi hematoloških toksičnih učinkov je lahko potrebno zmanjšanje odmerka ali prekinitev oz. odložitev zdravljenja.
In the study in dogs, the occurrence and severity of these lesions was reduced by lowering the dose or prolonging the intervals between doses.
Pri psih so pojavljanje in stopnjo jakosti teh lezij omilili z zmanjšanjem odmerka ali s podaljšanjem časovnega razmika med odmerki.
Pharmacotherapeutic group: Cytotoxic agents (anthracyclines and related substances), ATC code: L01DB01.
Farmakoterapevtska skupina: citotoksična zdravila (antraciklinski antibiotiki in sorodne učinkovine), oznaka ATC: L01DB01.
Cardiac toxicity was defined as a decrease of 20 points or greater from baseline if the resting LVEF remained in the normal range or a decrease of 10 points or greater if the LVEF became abnormal (less than the lower limit for normal).
Kardiotoksičnost je bila opredeljena kot zmanjšanje za 20 točk ali več od začetne vrednosti, če je iztisni delež levega prekata (LVEF) v mirovanju ostal v normalnem razponu vrednosti, ali zmanjšanje za 10 točk ali več, če je iztisni delež levega prekata postal nenormalen (manjši od spodnje meje normale).
0.96-3.85 l/m2) approximating the plasma volume.
(razpon od 0,96 do 3,85 l/m2), kar se približuje volumnu plazme.
Wait until ANC  1,500 and platelets  75,000; decrease dose by 25% or continue full dose with growth factor support.
Počakajte, da bo AŠN  1.500 in število trombocitov  75.000; nato zmanjšajte odmerek za 25% ali nadaljujte s polnim odmerkom in podporo z rastnim faktorjem.
- For treatment of AIDS-related Kaposi's sarcoma (KS) in patients with low CD4counts (< 200 CD4 lymphocytes/mm
- Z aidsom povezanega Kaposijevega sarkoma (KS) pri bolnikih z majhnim številom celic CD4 (< 200 limfocitov CD4/mm
All Severities n=318
Vse jakosti n=318
The frequency of lichenoid keratosis was determined as “rare” based on clinical trials.
Pogostnost lihenoidne keratoze je bila na podlagi podatkov kliničnih študij določena kot “redka”.
The reported incidence of life-threatening (grade 4) cases was < 1%.
Incidenca smrtno nevarnih (4. stopnje) primerov je bila < 1%.
To manage adverse events such as palmar-plantar erythrodysesthesia (PPE), stomatitis or haematological toxicity, the dose may be reduced or delayed.
Za obvladovanje neželenih učinkov, npr. palmarno-plantarne eritrodizestezije (PPE), stomatitisa ali hematološke toksičnosti, lahko odmerek zdravila zmanjšate ali odložite njegovo dajanje.
In the breast cancer trial program, modification of the infusion was permitted for those patients experiencing an infusion reaction as follows: 5% of the total dose was infused slowly over the first 15 minutes.
V raziskavi raka dojk so pri bolnicah z infuzijsko reakcijo dovolili naslednjo prilagoditev infundiranja: 5% celotnega odmerka so infundirali počasi v prvih 15 minutah.
The hypotensive response was reduced in magnitude by pretreatment with antihistamines.
Stopnjo hipotenzivnega učinka je zmanjšala premedikacija z antihistaminiki.
It did not interfere with patients completing therapy and no dosage adjustments are generally required, unless stomatitis is affecting a patient's ability to eat.
Zaradi stomatitisa ni bilo treba predčasno prekiniti zdravljenja in prilagoditev odmerka zdravila praviloma ni potrebna, razen če stomatitis negativno vpliva na zmožnost bolnika za uživanje hrane.
Grade 1 1,500 - 1,900
Stopnja 2 1.000 - < 1.500
Infusion reactions rarely recur after the first treatment cycle with Caelyx (see section 4.2).
Infuzijske reakcije se po prvem krogu zdravljenja z zdravilom Caelyx ponovijo le redko (glejte poglavje 4.2).
For common adverse events which required dose modification or discontinuation see section 4.8.
Za pogoste neželene učinke, ki so zahtevali prilagoditev odmerka ali ukinitev zdravila, glejte poglavje 4.8.
Although the biological mechanism of lichenoid keratosis after doxorubicin is not known, the PRAC considers that “lichenoid keratosis” should be included as a new adverse drug reaction in section 4.8 of the SmPC based on the review of the cases.
Čeprav biološki mehanizen lihenoidne keratoze po uporabi doksorubicina ni znan, je odbor PRAC mnenja, da je treba na podlagi pregleda primerov “lihenoidno keratozo” kot nov neželeni učinek vključiti v poglavje 4.8 Povzetka glavnih značilnosti zdravila (SmPC).
Grade 3 or 4 non-haematologic medicine related toxicity
V primeru pojava nehematološke toksičnosti 3. ali 4. stopnje, povezane z uporabo zdravila
Pyridoxine at a dose of 50-150 mg per day and corticosteroids have been used for the prophylaxis and treatment of PPE, however, these therapies have not been evaluated in phase III trials.
Za profilakso in zdravljenje PPE so uporabljali piridoksin v odmerku 50 do 150 mg na dan in kortikosteroide, vendar tovrstnega zdravljenja še niso ovrednotili v raziskavah faze III.
This interim analysis showed a TTP risk reduction of 45% (95% CI: 29-57%), p < 0.0001.
Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45% (95% IZ; od 29 do 57%), p < 0,0001.
These linear MPEG groups extend from the liposome surface creating a protective coating that reduces interactions between the lipid bilayer membrane and the plasma components.
Te linearne skupine MPEG segajo s površine liposomov in oblikujejo zaščitno prevleko, ki zmanjšuje medsebojno delovanje med lipidno dvoplastno membrano in sestavinami plazme.
What you need to know before you use Caelyx
Kaj morate vedeti, preden boste uporabili zdravilo Caelyx
Stinging or swelling of the skin at the site of injection may also occur.
Pojavi se lahko tudi občutek zbadanja ali otekanje kože na mestu injiciranja.
Very rarely, convulsions have been observed in relation to infusion reactions.
Zelo redko se lahko v povezavi z infuzijskimi reakcijami pojavijo tudi konvulzije.
Cases of secondary oral cancer were diagnosed both, during treatment with Caelyx, and up to 6 years after the last dose.
Primere sekundarnega raka v ustni votlini so ugotovili tako med zdravljenjem z zdravilom Caelyx in še do 6 let po zadnjem odmerku.
It is recommended that all patients receiving Caelyx routinely undergo frequent ECG monitoring.
Pri vseh bolnikih, ki prejemajo zdravilo Caelyx, je priporočljivo rutinsko pogosto spremljanje EKG.
Patients should be examined at regular intervals for the presence of oral ulceration or any oral discomfort that may be indicative of secondary oral cancer.
Bolnike je treba redno pregledovati na prisotnost razjed v ustni votlini ali zaradi kakršnega koli neprijetnega občutka v ustih, ki bi lahko kazal na sekundarno neoplazmo v ustih.
PPE is characterised by painful, macular reddening skin eruptions.
Za PPE je značilen boleč, makularen pordel kožni izpuščaj.
The incidence of life threatening (grade 4) haematologic effects was < 1.0% and sepsis was reported in 1% of patients.
Incidenca smrtno nevarnih (4. stopnja) hematoloških učinkov je bila < 1,0%, o sepsi pa so poročali pri 1% bolnikov.
The apparent half-life ranged from 24-231 hours, with a mean of 73.9 hours.
Navidezni razpolovni čas je od 24 do 231 ur, srednja vrednost pa je 73,9 ur.
At equivalent doses, the plasma concentration and AUC values of Caelyx which represent mostly pegylated liposomal doxorubicin hydrochloride (containing 90% to 95% of the measured doxorubicin) are significantly higher than those achieved with standard doxorubicin hydrochloride preparations.
V ekvivalentnih odmerkih sta plazemska koncentracija in vrednost AUC za Caelyx, ki predstavljata predvsem pegiliran liposomski doksorubicinijev klorid (vsebuje 90% do 95% izmerjenega doksorubicina), bistveno večja kot pri standardnih pripravkih doksorubicinijevega klorida.
Grades 3/4** n=318
3. ali 4. stopnje** n=318
Determine the dose of Caelyx to be administered (based upon the recommended dose and the patient's body surface area).
Določite odmerek zdravila Caelyx, ki ga mora bolnik prejeti (glede na priporočeni odmerek in bolnikovo telesno površino).
Dose modification in patients with AIDS-KS is addressed in section 4.8.
Prilagoditev odmerka za bolnike, ki imajo z aidsom povezan Kaposijev sarkom, je opisana v poglavju 4.8.
Caelyx must not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic alfa-interferon.
Zdravila Caelyx ne smete uporabljati za zdravljenje z aidsom povezanega Kaposijevega sarkoma, ki bi ga bilo mogoče učinkovito zdraviti lokalno ali s sistemskim interferonom alfa.
Store in a refrigerator (2C - 8C).
Shranjujte v hladilniku (2 °C-8 °C).
3 and/or the platelet count is < 50,000/mm
3 in/ali število trombocitov < 50.000/mm
This process is known as pegylation and protects liposomes from detection by the mononuclear phagocyte system (MPS), which increases blood circulation time.
Ta postopek, znan kot pegilacija, zavaruje liposome pred tem, da bi jih spoznal mononuklearni fagocitni sistem (MPS), kar podaljša njihovo zadrževanje v krvnem obtoku.
Breast cancer n=404
Rak dojk n=404
Other medicines and Caelyx Tell your doctor or pharmacist - if you are taking or have recently taken any other medicines, including medicines obtained without a prescription; - about any other cancer treatments you are on or have been taking, as particular care needs to be taken with treatments which reduce the number of white blood cells, as this may cause further reduction in the number of white blood cells.
Druga zdravila in zdravilo Caelyx Obvestite svojega zdravnika ali farmacevta - če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta - o vsakem drugem zdravilu proti raku, ki ga jemljete ali ste ga jemali, saj je pri jemanju zdravil, ki zmanjšajo število levkocitov, potrebna posebna previdnost, ker lahko ta zdravila dodatno zmanjšajo število levkocitov.
In patients with cardiac disease requiring treatment, administer Caelyx only when the benefit outweighs the risk to the patient.
Pri bolnikih s srčno boleznijo, ki zahteva zdravljenje, uporabite zdravilo Caelyx le, če koristi zdravljenja odtehtajo tveganje za bolnika.
Doxorubicin becomes available after the liposomes are extravasated and enter the tissue compartment.
Doksorubicin postane razpoložljiv, ko liposomi ekstravazirajo in preidejo v tkivni prostor.
In contrast, the pharmacokinetic profile of Caelyx indicates that Caelyx is confined mostly to the vascular fluid volume and that the clearance of doxorubicin from the blood is dependent upon the liposomal carrier.
V nasprotju s tem pa kaže farmakokinetični profil zdravila Caelyx, da je zdravilo v glavnem omejeno na volumen žilne tekočine in da je očistek doksorubicina iz krvi odvisen od liposomskega nosilca.
The evaluation of left ventricular function is considered to be mandatory before each additional administration of Caelyx that exceeds a lifetime cumulative anthracycline dose of 450 mg/m
Ocena delovanja levega prekata je nujna pred vsakim dodatnim dajanjem zdravila Caelyx, ki presega življenjski kumulativni odmerek antraciklinov 450 mg/m
Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with Caelyx.
Ker lahko doksorubicinijev klorid škoduje dojenčku, mora ženska prenehati z dojenjem še pred začetkom zdravljenja z zdravilom Caelyx.
Take the appropriate volume of Caelyx up into a sterile syringe.
Izvlecite ustrezni volumen zdravila Caelyx v sterilno brizgo.
Secondary haematological malignancies
Sekundarne hematološke maligne bolezni
Therefore, any patient treated with doxorubicin should be kept under haematological supervision.
Zato je treba vse bolnike, zdravljene z doksorubicinom, hematološko nadzorovati.
The suspension is sterile, translucent and red.
Suspenzija je sterilna, prosojna in rdeče barve.
During clinical trials in patients with solid tumours (including breast and ovarian cancer) who have received concomitant cyclophosphamide or taxanes, no new additive toxicities were noted.
Med kliničnimi raziskavami pri bolnikih s solidnimi tumorji (vključno z rakom dojk ali rakom jajčnikov), sočasno zdravljenih s ciklofosfamidom ali taksani, niso zasledili novih aditivnih toksičnih učinkov.
Following marketing, bullous eruption has been reported rarely in this population.
V obdobju trženja zdravila so pri tej populaciji poročali o redkih primerih z buloznim izpuščajem.
It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival.
Zdravilo uničuje rakave celice, zmanjšuje velikost tumorja in upočasni njegovo rast ter podaljšuje preživetje bolnice.
In rare cases, having low white blood cells may lead to severe infection.
V redkih primerih lahko premajhno število levkocitov privede do hude okužbe.
If any signs or symptoms of extravasation occur (e.g., stinging, erythema) terminate the infusion immediately and restart in another vein.
Če se pojavijo kakršni koli znaki ali simptomi ekstravazacije (npr. občutek zbadanja, eritem), je treba infundiranje nemudoma prekiniti in infuzijo nastaviti na drugi veni.
Because the active ingredient doxorubicin hydrochloride in Caelyx may cause birth defects, it is important to tell your doctor if you think you are pregnant.
Ker lahko učinkovina zdravila Caelyx, doksorubicinijev klorid, povzroči prirojene napake pri novorojencu, je pomembno, da zdravniku poveste, če mislite, da ste noseči.
Increases in AST were less frequently (< 1%) reported.
O zvečanju koncentracije AST so poročali manj pogosto (< 1%).
What Caelyx is and what it is used for What you need to know before you use Caelyx How to use Caelyx
Kaj je zdravilo Caelyx in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Caelyx Kako uporabljati zdravilo Caelyx Možni neželeni učinki
Skin and subcutaneous tissue disorders rare lichenoid keratosis very rare erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis
Bolezni kože in podkožja redki lihenoidna keratoza zelo redki multiformni eritem, Stevens Johnson sindrom in toksična epidermalna nekroliza
Week 5
5. teden
In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/m2-1,680 mg/m2.
Dodatno so endomiokardno biopsijo opravili tudi pri 8 bolnikih s solidnimi tumorji s kumulativnimi odmerki antraciklinov od 509 do 1.680 mg/m2.
The use of gloves is required.
Pri delu morate uporabljati rokavice.
This leaflet was last approved on
Navodilo je bilo nazadnje revidirano {MM/LLLL}
If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a 60-minute period.
Če se ne pojavi infuzijska reakcija, lahko naslednje infuzije zdravila Caelyx date v 60 minutah.
The primary analysis of cardiac toxicity showed the risk of developing a cardiac event as a function of cumulative anthracycline dose was significantly lower with Caelyx than with doxorubicin (HR=3.16, p < 0.001).
Primarna analiza kardiotoksičnosti je pokazala, da je tveganje za kardialne sopojave kot funkcija kumulativnega odmerka antraciklina bistveno manjše pri zdravilu Caelyx kot pri standardnem doksorubicinu (HR = 3,16, p < 0,001).
Other strategies to prevent and treat PPE include keeping hands and feet cool, by exposing them to cool water (soaks, baths, or swimming), avoiding excessive heat/hot water and keeping them unrestricted (no socks, gloves, or shoes that are tight fitting).
Med drugimi načini za preprečevanje in zdravljenje PPE so hlajenje dlani in stopal s hladno vodo (namakanje, kopeli, plavanje), izogibanje prekomerni toploti ali topli vodi in skrb, da jih nič ne stiska (izogibanje nošenja nogavic, rokavic ali tesne obutve).
Evidence of penetration of pegylated liposomes from blood vessels and their entry and accumulation in tumours has been seen in mice with C-26 colon carcinoma tumours and in transgenic mice with KS-like lesions.
Znake prodiranja pegiliranih liposomov iz krvnih žil in njihovega vstopa ter kopičenja v tumorjih so opažali pri miših s karcinomskimi tumorji kolona C-26 in pri transgenskih miših z lezijami, podobnimi Kaposijevemu sarkomu.
Patient status
Stanje bolnika
The bortezomib regimen consists of 1.3 mg/m² on days 1, 4, 8, and 11 every 3 weeks.
Shema zdravljenja z bortezomibom sestoji iz infundiranja odmerkov po 1,3 mg/m² na 1., 4., 8. in 11. dan, na vsake 3 tedne.
Palmar-Plantar erythrodysesthesia Week after prior Caelyx dose
Palmarno-plantarna eritrodizestezija Teden po prejšnjem odmerku zdravila Caelyx
Whenever cardiomyopathy is suspected, i.e., the left ventricular ejection fraction has substantially decreased relative to pre-treatment values and/or left ventricular ejection fraction is lower than a prognostically relevant value (e.g., < 45%), endomyocardial biopsy may be considered and the benefit of continued therapy must be carefully evaluated against the risk of developing irreversible cardiac damage.
Kadarkoli se pojavi sum na kardiomiopatijo, tj. če se iztisni delež levega prekata bistveno zmanjša glede na vrednost pred začetkom zdravljenja in/ali je iztisni delež levega prekata manjši od prognostično relevantne vrednosti (npr. < 45%), po potrebi opravite endomiokardno biopsijo in skrbno pretehtajte koristi nadaljnjega zdravljenja v primerjavi s tveganjem za ireverzibilno okvaro srca.
As doxorubicin is metabolised by the liver and excreted in the bile, dose modification should not be required.
Ker se doksorubicin presnavlja v jetrih in izloča z žolčem, prilagoditev odmerka naj ne bi bila potrebna.
Growth factor support or transfusion support was necessary in 5.1% and 5.5% of patients, respectively (see section 4.2).
Podpora z dajanjem rastnega faktorja je bila potrebna pri 5,1% bolnikov, dajanje transfuzij pa pri 5,5% bolnikov (glejte poglavje 4.2).
The total dose of doxorubicin hydrochloride must also take into account any previous (or concomitant) therapy with cardiotoxic compounds such as other anthracyclines/anthraquinones or e.g., 5-fluorouracil.
Pri celokupnem odmerku doksorubicinijevega klorida morate upoštevati tudi morebitno predhodno ali sočasno zdravljenje s kardiotoksičnimi spojinami, npr. z drugimi antraciklini ali antrakinoni ali npr. 5-fluorouracilom.
In those patients who experience an infusion reaction, the method of infusion should be modified as follows:
Pri bolnicah z infuzijsko reakcijo prilagodite način infundiranja zdravila, kot sledi:
Caelyx is also used to produce an improvement in your Kaposi's sarcoma including flattening, lightening and even shrinkage of the cancer.
Zdravilo Caelyx se uporablja tudi za izboljšanje stanja pri Kaposijevem sarkomu, vključno s sploščenjem rakavih poškodb, njihovo posvetlitvijo in celo zmanjšanjem velikosti.
Prior to Caelyx administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/AST, alkaline phosphatase, and bilirubin.
Pred uporabo zdravila Caelyx morate oceniti delovanje jeter z običajnimi kliničnimi laboratorijskimi testi, npr. ALT/AST, alkalno fosfatazo in bilirubinom.
PPE*, alopecia, rash PPE*
PPE*, alopecija, izpuščaj
Avoid becoming pregnant while you or your partner are taking Caelyx and in the six months following discontinuation of Caelyx treatment.
Pazite, da ne zanosite v času, ko vi ali vaš partner prejemate zdravilo Caelyx, in še šest mesecev po prekinitvi zdravljenja z njim.
In nearly all patients, Caelyx treatment can be resumed after all symptoms have resolved without recurrence.
Pri skoraj vseh bolnikih lahko zdravljenje z zdravilom Caelyx nadaljujete, ko izginejo vsi simptomi, in ti se potem ne ponovijo.
In a subset of 410 patients with ovarian cancer, clinically significant laboratory abnormalities occurring in clinical trials with Caelyx included increases in total bilirubin (usually in patients with liver metastases) (5%) and serum creatinine levels (5%).
V podskupini 410 bolnic z rakom jajčnikov so bili med klinično pomembnimi nenormalnimi laboratorijskimi izvidi, ki so se pojavili v kliničnih preskušanjih z zdravilom Caelyx, zvečanje koncentracije celokupnega bilirubina (običajno pri bolnikih z jetrnimi metastazami) (5%) in serumske koncentracije kreatinina (5%).
The treatment HR for PFS when adjusted for prognostic variables was consistent with PFS for the ITT population.
Terapevtski HR za PFS, korigiran z upoštevanjem prognostičnih spremenljivk, je bil v skladu z vrednostjo PFS za populacijo, ki naj bi jo zdravili ("intent-to-treat").
Population pharmacokinetic data (in the range of creatinine clearance tested of 30-156 ml/min) demonstrate that Caelyx clearance is not influenced by renal function.
Podatki populacijske farmakokinetike (v testiranem razponu očistka kreatinina od 30 do 156 ml/min) kažejo, da delovanje ledvic ne vpliva na ledvični očistek zdravila Caelyx.
Some of these abnormalities may have been related to the underlying HIV infection and not Caelyx.
Nekateri od teh nenormalnih laboratorijskih izvidov so lahko posledica okužbe s HIV in ne uporabe zdravila Caelyx.
Rare side effects (may affect up to 1 in 1,000 people) - blue colour to the skin and mucosa caused by low oxygen in the blood; - patches of skin thickening.
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - modro obarvana koža in sluznice zaradi nizke vsebnosti kisika v krvi, - zadebelitev delov kože.
Do not use Caelyx - if you are allergic to doxorubicin hydrochloride, peanut or soya, or any of the ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Caelyx - če ste alergični na doksorubicinijev klorid, arašide, sojo ali katero koli sestavino tega zdravila
Do not use material that shows evidence of precipitation or any other particulate matter.
Ne uporabljajte pripravka, ki kaže znake obarjanja ali vsebuje kakršnekoli druge vidne delce.
The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom.
Although local necrosis following extravasation has been reported very rarely, Caelyx is considered to be an irritant.
Čeprav so o lokalni nekrozi po ekstravazaciji poročali zelo redko, zdravilo Caelyx velja za dražečo snov.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Week 6
6. teden
Renal toxicity has been observed with even lower single doses of doxorubicin HCl in rats and rabbits.
Ledvično toksičnost pa so opažali tudi pri manjših enkratnih odmerkih doksorubicin klorida pri podganah in kuncih.
- In combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
- V kombinaciji z bortezomibom za zdravljenje napredovalega diseminiranega plazmocitoma pri bolnikih, ki so pred tem že prejeli najmanj eno vrsto predhodnega zdravljenja in so bodisi že imeli presaditev kostnega mozga ali pa niso primerni zanjo.
Infusion reactions rarely recur after the first treatment cycle.
Infuzijske reakcije se le redko ponovijo po prvem krogu kemoterapije.
In the pivotal trial in patients with ovarian cancer treated at a dose of 50 mg/m myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis.
V osrednji raziskavi pri bolnicah z rakom jajčnikov, zdravljenih z odmerkom 50 mg/m2, je bila mielosupresija na splošno blaga do zmerna in reverzibilna ter ni bila povezana z epizodami okužb zaradi nevtropenije ali sepso.