natgillin/translations-raw huggingface dataset:
Caelyx is not recommended in patients below 18 years of age. 
Zdravljenje bolnikov, mlajših od 18 let, z zdravilom Caelyx ni priporočljivo.
During repeat dose toxicology studies in dogs, an acute response characterised by hypotension, pale mucous membranes, salivation, emesis and periods of hyperactivity followed by hypoactivity and lethargy was observed following administration of pegylated liposomes (placebo). 
Med toksikološkimi raziskavami uporabe večkratnih odmerkov zdravila pri psih so po uporabi pegiliranih liposomov (placeba) opažali akutni odziv s hipotenzijo, bledico sluznic, slinjenjem, emezo in obdobjem hiperaktivnosti, ki sta ji sledili hipoaktivnost in letargija.
Investigations common weight loss 
Preiskave pogosti izguba telesne mase
Although no studies have been conducted with Caelyx, doxorubicin hydrochloride, the pharmacologically active ingredient of Caelyx, is mutagenic and carcinogenic. 
Čeprav z zdravilom Caelyx niso opravili raziskav mutagenosti in kancerogenosti, je doksorubicinijev klorid, farmakološka učinkovina v zdravilu Caelyx, mutagen in kancerogen.
Caelyx, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies. 
Kot druga zdravila doksorubicinijevega klorida lahko tudi zdravilo Caelyx okrepi toksičnost drugih zdravil proti raku.
Standard doxorubicin hydrochloride displays extensive tissue distribution (volume of distribution: 700 to 1,100 l/m 2) and a rapid elimination clearance (24 to 
Standardni doksorubicinijev klorid se izdatno porazdeli po tkivih (volumen porazdelitve: od 700 do 1.100 l/m2) in ima hiter eliminacijski očistek (24 to 73 l/uro/m2).
Uncommon side effects (may affect up to 1 in 100 people) - confusion; - inflammation of the veins and formation of blood clots in the veins which could lead to blockage of blood flow to your lungs causing difficulty breathing, chest pain and palpitations; - abnormal heart rhythm, heart beat feels fast or uneven (palpitations), heart failure, which makes you short of breath and may lead to swollen legs, cardiac arrest. 
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - zmedenost - vnetje ven in nastanek krvnih strdkov v venah, ki lahko zamašijo pretok krvi do pljuč in povzročijo težave z dihanjem, bolečino v prsnem košu in razbijanje srca (palpitacije) - motnje srčnega ritma, pospešeno ali neenakomerno bitje srca (palpitacije), srčno popuščanje zaradi katerege težko dihate in lahko povzroči otekanje nog, zastoj srca.
It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ml) glucose. 
Priporočljivo je, da je infuzijska linija za zdravilo Caelyx prek stranskega nastavka priključena na intravensko infuzijo 5% (50 mg/ml) glukoze.
○C and ANC < 1,000/mm 
○C z absolutnim številom nevtrofilcev (AŠN) < 1.000/mm
For the sub-group of patients with platinum-sensitive disease the difference was greater: HR of 1.432 (95% CI: 1.066; 1.923), p=0.017. 
V podskupini bolnic z rakom, ki se je odzival na platinsko kemoterapijo, pa je bila ta razlika večja: razmerje med tveganji (HR) je bilo 1,432 (95% IZ; 1,066, 1,923), p=0,017.
In the pivotal phase III trial versus doxorubicin, 58/509 (11.4%) randomised subjects (10 treated with Caelyx at a dose of 50 mg/m2/every 4 weeks versus 48 treated with doxorubicin at a dose of 
V osrednji raziskavi faze III, v kateri so zdravilo Caelyx primerjali s standardnim doksorubicinom, je 58 od 509 (11,4%) randomiziranih preiskovancev (od tega jih je bilo 10 zdravljenih z zdravilom Caelyx v odmerku 50 mg/m2 na vsake 4 tedne in 48 s standardnim doksorubicinom v odmerku
Stomatitis/mucositis and nausea were also commonly reported in breast/ovarian cancer patient populations, whereas the AIDS-KS Program (20 mg/m2 every 2 weeks), myelosuppression (mostly leukopaenia) was the most common side effect (see AIDS-KS). 
Pri bolnicah z rakom dojk in rakom jajčnikov so pogosto poročali tudi o stomatitisu oz. mukozitisu ter navzei, medtem ko je bil v programu raziskav z aidsom povezanega Kaposijevega sarkoma (20 mg/m2 na vsaka 2 tedna) najpogostejši neželeni učinek mielosupresija, večinoma v smislu levkopenije (glejte poglavje o z aidsom povezanem Kaposijevem sarkomu).
Caution must be exercised when giving any other cytotoxic agents, especially myelotoxic agents, at the same time. 
Med sočasno uporabo drugih citotoksičnih zdravil, zlasti mielotoksičnih, je potrebna previdnost.
Exercise caution in the concomitant use of medicinal products known to interact with standard doxorubicin hydrochloride. 
Med sočasno uporabo zdravil, za katera je znano, da medsebojno delujejo s standardnim doksorubicinijevim kloridom, je potrebna previdnost.
Caelyx must not be given by the intramuscular or subcutaneous route. 
Zdravila Caelyx ne smete dajati intramuskularno ali subkutano.
Caelyx in patients has not suggested a significant nephrotoxicity liability of Caelyx, these findings in monkeys may not have relevance to patient risk assessment. 
Ker ovrednotenje podatkovne baze o varnosti zdravila Caelyx za bolnike v postmarketinškem obdobju ni pokazalo bistvene nefrotoksične obremenitve zaradi jemanja zdravila Caelyx, omenjeni izsledki pri opicah morda niso pomembni za oceno tveganja pri bolnikih.
You should tell your doctor about any of the following: - if you are receiving any treatment for heart disease or liver disease; - if you are diabetic, because Caelyx contains sugar which may require an adjustment to the treatment of your diabetes; - if you have Kaposi's sarcoma and have had your spleen removed; - if you notice sores, discolouration or any discomfort in your mouth. 
Svojega zdravnika morate obvestiti, če imate kaj od naslednjega: - če prejemate kakršna koli zdravila za srčno ali jetrno bolezen - če imate sladkorno bolezen, saj zdravilo Caelyx vsebuje sladkor, zaradi česar bo morda treba prilagoditi zdravljenje sladkorne bolezni
* Palmar-plantar erythrodysesthesia (Hand-foot syndrome). 
* Palmarno-plantarna eritrodisestezija (sindrom rok in stopal).
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the Caelyx plus bortezomib combination therapy patients. 
Mediana vrednost TTP je znašala 6,5 mesecev pri bolnikih, ki so prejemali monoterapijo z bortezomibom, v primerjavi z vrednostjo 9,3 mesece pri tistih, ki so prejemali kombinirano terapijo z zdravilom Caelyx in bortezomibom.
Driving and using machines Do not drive or use any tools or machines if you feel tired or sleepy from treatment with Caelyx. 
Vpliv na sposobnost upravljanja vozil in strojev Če ste zaradi zdravljenja z zdravilom Caelyx utrujeni ali zaspani, ne upravljajte vozil in strojev.
In patients with AIDS, exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with standard doxorubicin hydrochloride. 
Pri bolnikih z aidsom so med uporabo standardnega doksorubicinijevega klorida opisali poslabšanje hemoragičnega cistitisa, ki ga je povzročila uporaba ciklofosfamida, in povečanje hepatotoksičnosti 6-merkaptopurina.
Table 4, below provides the schedule followed for other dose modifications in the clinical trial in the treatment of patients with multiple myeloma receiving Caelyx and bortezomib combination therapy. 
V Preglednici 4 spodaj je podan načrt, ki so ga uporabljali za druge prilagoditve odmerka v kliničnem preskušanju zdravljenja bolnikov z diseminiranim plazmocitomom, ki prejemajo zdravilo Caelyx v kombinaciji z bortezomibom.
Given the difference in pharmacokinetic profiles and dosing schedules, Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride. 
Zaradi razlik v farmakokinetičnih značilnostih in režimu odmerjanja, zdravila Caelyx ne smete prosto zamenjevati z drugimi zdravili z doksorubicinijevim kloridom.
Caelyx concentrate for solution for infusion: vials which provide 10 ml (20 mg) or 25 ml (50 mg). 
Caelyx 2 mg/ml koncentrat za raztopino za infundiranje: viale, ki vsebujejo po 10 ml (20 mg) ali 25 ml (50 mg) zdravilne učinkovine.
Caelyx is indicated: - As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. 
Zdravilo Caelyx je indicirano za zdravljenje: - Metastatskega raka dojk pri bolnicah s povečanim tveganjem za bolezni srca, v obliki monoterapije.
Caelyx is an antitumour agent. 
Caelyx je zdravilo s protitumornim delovanjem.
With Caelyx, the encapsulation of doxorubicin hydrochloride in pegylated liposomes results in these effects having a differing strength, as follows. 
Inkapsuliranost doksorubicinijevega klorida v pegiliranih liposomih pri zdravilu Caelyx povzroči, da imajo ti učinki drugačno jakost, kar je opisano v nadaljevanju.
Permanent treatment discontinuation was infrequently reported at 2%. 
O dokončni prekinitvi zdravljenja so poročali redko, t.j.
This allows the Caelyx liposomes to circulate for prolonged periods in the blood stream. 
To liposomom z zdravilom Caelyx omogoči, da dlje časa krožijo v krvnem obtoku.
If tolerated without reaction, the infusion rate was doubled for the next 15 minutes. 
Če je bolnica to dobro prenašala in ni imela reakcije, so v naslednjih 15 minutah podvojili hitrost infundiranja.
Do not dose until recovered to grade < 2 and reduce dose by 25% for all subsequent doses. 
Ne infundirajte zdravila, dokler bolnik ne okreva do stopnje toksičnosti < 2, potem pa pri vseh naslednjih odmerkih zmanjšajte velikost njegovega odmerka za 25% .
** Grade 3/4 adverse events are based on the adverse event terms of all severities with an overall incidence ≥ 5% (see adverse events listed in first column). 
** Neželeni učinki 3. ali 4. stopnje so navedeni s termini pogostnosti za neželene učinke vseh jakosti s splošno incidenco
In patients with multiple myeloma receiving Caelyx plus bortezomib, infusion-associated reactions have been reported at a rate of 3%. 
Pri bolnikih z diseminiranim plazmocitomom, ki so prejemali zdravilo Caelyx v kombinaciji z bortezomibom, so o infuzijskih reakcijah poročali s 3% pogostnostjo.
How to use Caelyx 
Kako uporabljati zdravilo Caelyx
Grade 1 (painless ulcers, erythema, or mild soreness) 
Stopnja 1 (neboleče razjede, eritem ali blage bolečine)
Metabolism and nutrition disorders common anorexia 
Presnovne in prehranske motnje pogosti anoreksija
Endomyocardial biopsies on nine of ten AIDS-KS patients receiving cumulative doses of Caelyx greater than 460 mg/m2 indicate no evidence of anthracycline-induced cardiomyopathy. 
Pri devetih od desetih bolnikov, ki so imeli z aidsom povezani Kaposijev sarkom in so prejeli kumulativni odmerek zdravila Caelyx nad 460 mg/m2, endomiokardna biopsija ni pokazala nobenih znakov antraciklinske kardiomiopatije.
During the infusion of Caelyx, the following reactions may occur: flushing of the face, shortness of breath, headache, chills, back pain, tightness in the chest and/or throat, sore throat, low or increase in blood pressure, rapid heart beat, puffing of the face, fever, dizziness, nausea, indigestion, itching, rash and sweating. 
Med infuzijo zdravila Caelyx se lahko pojavijo naslednje reakcije: rdečica obraza, težko dihanje, glavobol, mrzlica, bolečine v hrbtu, stiskanje v prsih in/ali žrelu, vnetje žrela, nizek ali zvišan krvni tlak, hiter srčni utrip, zabuhlost obraza, zvišana telesna temperatura, omotica, slabost, prebavne motnje, srbenje, izpuščaj in znojenje.
The mean intrinsic clearance of Caelyx was 0.030 l/h/m (range 0.008 to 0.152 l/h/m2) and the mean central volume of distribution was 1.93 l/m 
Srednja vrednost intrinzičnega očistka zdravila Caelyx je 0,030 l/uro/m (razpon od 0,008 do 0,152 l/uro/m2), srednja vrednost osrednjega volumna porazdelitve pa 1,93 l/m
Pyridoxine (Vitamin B6): - vitamin B6 is available without prescription; - take 50-150 mg daily beginning at the first signs of redness or tingling. 
Piridoksin (vitamin B6): - Vitamin B6 je na voljo brez recepta.
However, in contrast to the experience with patients with AIDS-KS, when Caelyx was compared to a standard treatment for advanced ovarian cancer (topotecan), the risk of infections was substantially lower in the Caelyx-treated patients. 
Toda v nasprotju z izkušnjami pri bolnikih z aidsom in Kaposijevem sarkomom je bila nevarnost za okužbe pri bolnicah z napredovalim rakom jajčnikov, ki so prejemale Caelyx, bistveno manjša kot pri standardnem zdravljenju raka jajčnikov (topotekan).
The pharmacokinetics of Caelyx was evaluated in 120 patients from 10 different clinical trials using the population pharmacokinetic approach. 
Farmakokinetiko zdravila Caelyx so ovrednotili po načelih populacijske farmakokinetike pri 120 bolnikih iz 10 različnih kliničnih raziskav.
The survival rates at 1, 2 and 3 years were 74.1%, 51.2% and 28.4% respectively on Caelyx, compared to 66.2%, 31.0% and 17.5% on topotecan. 
Stopnje preživetja za Caelyx so bile po 1 letu 74,1%, po 2 letih 51,2% in po 3 letih 28,4%, v primerjavi z ustreznimi stopnjami za topotekan, ki so bile 66,2%, 31,0% in 17,5%.
Pegylated liposomes contain surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol (MPEG). 
Pegilirani liposomi vsebujejo površinsko vezane delce hidrofilnega polimera metoksipolietilenglikola (MPEG).
Of 646 patients with multiple myeloma who have received at least 1 prior therapy, 318 patients were treated with combination therapy of Caelyx 30 mg/m2 as a one hour intravenous infusion administered on day 4 following bortezomib which is administered at 1.3 mg/m² on days 1, 4, 8, and 11, every three weeks or with bortezomib monotherapy in a phase III clinical trial. 
Program zdravljenja diseminiranega plazmocitoma Od 646 bolnikov z diseminiranim plazmocitomom, ki so prejeli najmanj eno vrsto predhodnega zdravljenja, jih je bilo skupaj 318 zdravljenih s kombinirano terapijo z zdravilom Caelyx v odmerku 30 mg/m2 v obliki enourne intravenske infuzije, dane na 4. dan po bortezomibu (le-tega pa so infundirali v odmerku 1,3 mg/m² v 1., 4., 8. in 11. dnevu na vsake tri tedne), oziroma z bortezomibom v monoterapiji v kliničnem preskušanju faze III. Za neželene učinke, poročane pri ≥ 5% bolnikov, zdravljenih z zdravilom Caelyx v kombinaciji z bortezomibom, glejte Preglednico 7.
Moreover, in a controlled clinical trial of Caelyx vs. topotecan, the incidence of treatment related sepsis was substantially less in the Caelyx-treated ovarian cancer patients as compared to the topotecan treatment group. 
Poleg tega je bila v nadzorovani klinični raziskavi zdravila Caelyx v primerjavi s topotekanom incidenca z zdravljenjem povezane sepse bistveno manjša pri bolnicah z rakom jajčnikov, ki so prejemale zdravilo Caelyx, kot v skupini, ki je prejemala topotekan.
From a clinical study in patients with AIDS-KS comparing Caelyx against another treatment (bleomycin/vincristine), there may be a higher chance of some infections with Caelyx. 
Klinična raziskava pri bolnikih z aidsom in Kaposijevem sarkomom, v kateri so zdravilo Caelyx primerjali z drugim načinom zdravljenja (z bleomicinom in vinkristinom), je pokazala, da je nevarnost za pojav nekaterih okužb lahko večja pri prejemanju zdravila Caelyx.
The dose should be repeated as long as patients respond satisfactorily and tolerate treatment. 
Infuzije navedenega odmerka ponavljajte dokler se bolnik zadovoljivo odziva na zdravljenje in ga dobro prenaša.
For doses < 90 mg, dilute Caelyx in 250 ml, and for doses  90 mg, dilute Caelyx in 500 ml. 
Za odmerke < 90 mg razredčite Caelyx v 250 ml, za odmerke ≥ 90 mg pa v 500 ml.
Breast cancer Grades 3/4 n=254 
Rak dojk stadij 3. ali 4. stopnje n=254
The pharmacokinetics of Caelyx determined in 18 patients with breast carcinoma were similar to the pharmacokinetics determined in the larger population of 120 patients with various cancers. 
Farmakokinetika zdravila Caelyx, ugotovljena pri 18 bolnicah z rakom dojk, je bila podobna farmakokinetiki pri večji populaciji 120 bolnikov z različnimi vrstami raka.
A similar low incidence of myelosuppression was seen in patients with metastatic breast cancer receiving Caelyx in a first-line clinical trial. 
Podobno majhno incidenco mielosupresije so ugotavljali tudi pri bolnicah z metastatskim rakom dojk v klinični raziskavi, v kateri so zdravilo Caelyx uporabili kot zdravljenje prve izbire.
Exercise caution in patients with impaired cardiac function who receive Caelyx. 
Pri bolnikih z okvarjenim delovanjem srca, ki prejemajo zdravilo Caelyx, morate biti previdni.
Week after prior Caelyx dose 
Teden po prejšnjem odmerku zdravila Caelyx
The plasma pharmacokinetics of Caelyx were evaluated in 23 patients with KS who received single doses of 20 mg/m2 administered by a 30-minute infusion. 
Bolniki, ki imajo z aidsom povezan Kaposijev sarkom Plazemsko farmakokinetiko zdravila Caelyx so ovrednotili pri 23 bolnikih s Kaposijevim sarkomom, ki so prejeli po en odmerek 20 mg/m2 v 30-minutni infuziji.
If tolerated without reaction, the infusion rate may then be doubled for the next 15 minutes. 
Če bolnica to dobro prenese in nima reakcije, lahko v naslednjih 15 minutah podvojite hitrost infuzije.
The survival rates at 1, 2 and 3 years were 41.5%, 21.1% and 13.8% respectively on Caelyx, compared to 43.2%, 17.2% and 9.5% on topotecan. 
Stopnje preživetja za Caelyx so bile po 1 letu 41,5%, po 2 letih 21,1% in po 3 letih 13,8%, v primerjavi z ustreznimi stopnjami za topotekan, ki so bile 43,2%, 17,2% in 9,5%.
Temporarily suspend Caelyx treatment in patients when the ANC count is < 1,000/mm 
Zdravljenje z zdravilom Caelyx začasno prekinite pri bolnikih, ki imajo absolutno število nevtrofilcev < 1.000/mm
The mean intrinsic clearance was 0.021 l/h/m2 (range 0.009-0.041 l/h/m2), the mean central volume of distribution was 1.95 l/m 2 (range 1.67-2.40 l/m 2). 
Srednja vrednost intrinzičnega očistka je bila 0,021 l/uro/m2 (razpon od 0,009 do 0,041 l/uro/m2), srednja vrednost osrednjega volumna porazdelitve pa 1,95 l/m 2 (razpon od 1,67 do 2,40 l/m 2).
The range of Billingham cardiotoxicity scores was grades 0-1.5. 
Razpon stopnje kardiotoksičnosti po Billinghamu je bil od 0 do 1,5, kar pomeni odsotnost kardiotoksičnosti ali le blago kardiotoksičnost.
Caelyx is administered at 30 mg/m² on day 4 of the bortezomib 3 week regimen as a 1 hour infusion administered immediately after the bortezomib infusion. 
Zdravilo Caelyx bolniku infundirajte v odmerku 30 mg/m² na 4. dan 3-tedenske sheme zdravljenja z bortezomibom v obliki 1-urne infuzije, ki jo dajte takoj po infuziji bortezomiba.
Fatigue, weakness, pain 
edem, edem nog občasni utrujenost, šibkost, bolečine
However, medications to treat these symptoms (e.g., antihistamines, corticosteroids, adrenaline, and anticonvulsants), as well as emergency equipment should be available for immediate use. 
Te simptome lahko običajno odpravimo z začasno prekinitvijo infuzije, običajno že brez dodatne terapije, kljub temu pa morate imeti vedno pri roki ustrezna zdravila za njihovo zdravljenje (npr. antihistaminike, kortikosteroide, adrenalin in antikonvulzive) in opremo za urgentno zdravljenje, pripravljeno za takojšnjo uporabo.
Uncommon  1/1,000 and < 1/100 Rare 
 1/1.000 in < 1/100
The mean intrinsic clearance was 0.016 l/h/m2 (range 0.008-0.027 l/h/m2), the mean central volume of distribution was 1.46 l/m 2 (range 1.10-1.64 l/m 2). 
Srednja vrednost intrinzičnega očistka je bila 0,016 l/uro/m2 (razpon od 0,008 do 0,027 l/uro/m2), srednja vrednost osrednjega volumna porazdelitve pa 1,46 l/m 2 (razpon od 1,10 do 1,64 l/m 2).
Grade 3 stomatitis was reported in 2% of patients in the combination therapy group. 
O stomatitisu 3. stopnje so poročali pri 2% bolnikov v skupini, ki je prejemala kombinirano zdravljenje, primerov stomatitisa 4. stopnje pa ni bilo.
Grade 2 (painful erythema, oedema, or ulcers, but can eat) 
Stopnja 2 (boleč eritem, edem ali razjede, vendar bolnik lahko je)
None of the 10 Caelyx subjects who had cardiac toxicity by LVEF criteria developed signs and symptoms of CHF. 
Pri nobenem od 10 bolnikov, ki so prejemali zdravilo Caelyx s kardiotoksičnostjo po merilih LVEF, se niso pojavili znaki ali simptomi kongestivnega srčnega popuščanja.
Caelyx, a liposome formulation, is doxorubicin hydrochloride encapsulated in liposomes with surface-bound methoxypolyethylene glycol (MPEG). 
Caelyx, liposomski pripravek, je doksorubicinijev klorid, inkapsuliran v liposomih s površinsko vezanim metoksipolietilenglikolom (MPEG).
The pharmacokinetics of Caelyx determined in 11 patients with ovarian carcinoma were similar to the pharmacokinetics determined in the larger population of 120 patients with various cancers. 
Farmakokinetika zdravila Caelyx, ugotovljena pri 11 bolnicah z rakom jajčnikov, je bila podobna farmakokinetiki pri večji populaciji 120 bolnikov z različnimi vrstami raka.
Please note that each vial of Caelyx contains sucrose and the dose is administered in 5% (50 mg/ml) glucose solution for infusion. 
Upoštevajte, da vsaka viala zdravila Caelyx vsebuje saharozo in da odmerek dajete v 5% (50 mg/ml) raztopini glukoze za infundiranje.
Excipients: -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide. 
Pomožne snovi: α-(2-[1,2-distearoil-sn-glicero(3)fosfooksi]etilkarbamoil)-ω-metoksipoli(oksietilen)40 natrijeva sol, popolnoma hidrogeniran sojin fosfatidilholin, holesterol, amonijev sulfat, saharoza, histidin, voda za injekcije, klorovodikova kislina, natrijev hidroksid.
CAELYX CARTON 50 mg/25 ml - 1 vial CAELYX CARTON 50 mg/25 ml - 10 vials 
CAELYX ŠKATLA 50 mg/25 ml - 1 viala CAELYX ŠKATLA 50 mg/25 ml - 10 vial
-(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)--methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE) fully hydrogenated soy phosphatidylcholine (HSPC) cholesterol ammonium sulphate sucrose histidine water for injections hydrochloric acid (for pH-adjustment) sodium hydroxide (for pH-adjustment) 
6.1 Seznam pomožnih snovi α-(2-[1,2-distearoil-sn-glicero(3)fosfooksi]etilkarbamoil)-ω-metoksipoli(oksietilen)-40 natrijeva sol (MPEG-DSPE) popolnoma hidrogeniran sojin fosfatidilholin (HSPC) holesterol amonijev sulfat saharoza histidin voda za injekcije klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
Grade 3 (painful erythema, edema, or ulcers, but cannot eat) 
Stopnja 3 (boleč eritem, edem ali razjede; bolnik ne more jesti)
One ml of Caelyx contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation. 
En ml zdravila Caelyx vsebuje 2 mg doksorubicinijevega klorida v pegiliranem liposomskem pripravku.
Partially used vials should be discarded. 
Delno porabljene viale zavrzite.
The survival rates at 1, 2 and 3 years were 56.3%, 34.7% and 20.2% respectively on Caelyx, compared to 54.0%, 23.6% and 13.2% on topotecan. 
Stopnje preživetja za Caelyx po 1 letu so bile 56, %, po 2 letih 34,7% in po 3 letih 20,2%, v primerjavi z ustreznimi stopnjami za topotekan, ki so bile 54,0%, 23,6% in 13,2%.
In controlled clinical studies in patients with AIDS-KS against a bleomycin/vincristine regimen, opportunistic infections were apparently more frequent during treatment with Caelyx. 
V nadzorovanih kliničnih študijah pri z aidsom povezanem Kaposijevem sarkomu so bile oportunistične okužbe med zdravljenjem z zdravilom Caelyx očitno pogostejše kot med zdravljenjem s kombinacijo bleomicina in vinkristina.
To minimise the risk of infusion reactions, the initial dose should be administered at a rate no greater than 1 mg/minute (see section 
Da bi tveganje za njihov pojav zmanjšali na najmanjšo možno mero, začetnega odmerka ne smete infundirati hitreje kot 1 mg/min (glejte poglavje 4.2).
There was a benefit in overall survival (OS) for Caelyx-treated patients over topotecan-treated patients as indicated by a hazard ratio (HR) of 1.216 (95% CI: 1.000; 1.478), p=0.050. 
Ugotovili so ugoden učinek zdravila v smislu daljšega skupnega preživetja pri bolnicah, zdravljenih z zdravilom Caelyx, od tistega pri bolnicah, zdravljenih s topotekanom, kot je pokazala vrednost razmerja med tveganji (HR) 1,216 (95% IZ; 1,000, 1,478), p=0,050.
CAELYX CARTON 20 mg/10 ml - 1 vial CAELYX CARTON 20 mg/10 ml - 10 vials 
CAELYX ŠKATLA 20 mg/10 ml - 1 viala CAELYX ŠKATLA 20 mg/10 ml - 10 vial