natgillin/translations-raw huggingface dataset:
The cumulative dose at which cardiotoxicity would become a concern for these AIDS-KS patients (> 400 mg/m2) would require more than 20 courses of Caelyx therapy over 40 to 60 weeks.
Za dosego kumulativnega odmerka (> 400 mg/m2), pri katerem bi kardiotoksičnost pri teh bolnikih postala problem, bi bilo potrebnih več kot 20 krogov zdravljenja z zdravilom Caelyx v obdobju 40 do 60 tednov.
This is probably the result of intercalation of the anthracycline between adjacent base pairs of the DNA double helix thus preventing their unwinding for replication.
Do zavore verjetno pride zaradi vrivanja antraciklina med sosednje bazne pare dvojne vijačnice DNA, kar prepreči njeno razvitje, potrebno za podvojitev.
Furthermore, based on the pooled analysis of 4,231 patients across indications, the SmPC should be updated to in order to better detail the risk of cardiotoxicity associated with Caelyx.
Na podlagi analize združenih podatkov pri 4.321 bolnikih glede na indikacije, je treba posodobiti Povzetek glavnih značilnosti zdravila (SmPC), z namenom natančnejše opredelitve tveganja za pojav kardiotoksičnost pri uporabi zdravila Caelyx.
Grade 1 (mild erythema, swelling, or desquamation not interfering with daily activities)
Stopnja 1 (blag eritem, otekanje ali deskvamacija, ki ne ovira vsakodnevnih dejavnosti)
The evaluation tests and methods mentioned above concerning the monitoring of cardiac performance during anthracycline therapy are to be employed in the following order: ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy.
Omenjene preiskave in postopke za oceno delovanja srca in njegovo spremljanje med zdravljenjem z antraciklini uporabljajte v naslednjem vrstnem redu: spremljanje EKG, merjenje iztisnega deleža levega prekata, endomiokardna biopsija.
Redose unless patient has experienced a previous grade 3 or 4 skin toxicity, in which case wait an additional week
Ponovite odmerek, razen če ni bolnik prej imel kožne toksičnosti 3. ali 4. stopnje; v tem primeru počakajte še en teden.
The pharmacokinetics of Caelyx over the dose range of 10 mg/m2 to 60 mg/m2 was best described by a two compartment non-linear model with zero order input and Michaelis-Menten elimination.
Farmakokinetiko zdravila Caelyx v odmernem območju od 10 do 60 mg/m2 najbolje opiše dvoprostorni nelinearni model z vnosom ničelnega reda in MichaelisMentenovim izločanjem.
Clinically significant laboratory abnormalities frequently ( 5%) occurred including increases in alkaline phosphatase; AST and bilirubin which were believed to be related to the underlying disease and not Caelyx.
Pogosto ( 5%) so se pojavljali klinično pomembni nenormalni laboratorijski izvidi, vključno z zvišanjem koncentracije alkalne fosfataze ter zvišanjem koncentracije AST in bilirubina, za katera menijo, da sta posledica osnovne bolezni in ne uporabe zdravila Caelyx.
Do not dose; if 2 or more doses are not given in a cycle, reduce dose by 25% in following cycles.
Ne infundirajte, če v posameznem krogu bolniku niste dali dveh ali več odmerkov, mu zmanjšajte odmerek za 25% v naslednjih krogih.
Leukopaenia is the most frequent undesirable effect experienced with Caelyx in this population; neutropaenia, anaemia and thrombocytopaenia have been observed.
Levkopenija je najpogostnejši neželeni učinek zdravila Caelyx v tej populaciji; ugotavljali so tudi nevtropenijo, anemijo in trombocitopenijo.
Solid tumour patients: in a larger cohort of 929 patients with solid tumours (including breast cancer and ovarian cancer) predominantly treated at a dose of 50 mg/m2 every 4 weeks, the safety profile and incidence of adverse effects are comparable to those of the patients treated in the pivotal breast cancer and ovarian cancer trials.
Bolnice s solidnimi tumorji: v večji kohorti 929 bolnikov s solidnimi tumorji (vključno z rakom dojk in rakom jajčnikov), ki so jih zdravili pretežno z odmerkom 50 mg/m vsake 4 tedne, sta bila profil neželenih učinkov zdravila in incidenca neželenih učinkov podobna kot pri bolnicah, zdravljenih v osrednjih preskušanjih raka dojk in raka jajčnikov.
The pegylated liposomes also have a low permeability lipid matrix and internal aqueous buffer system that combine to keep doxorubicin hydrochloride encapsulated during liposome residence time in circulation.
Pegilirani liposomi imajo tudi lipidni matriks majhne permeabilnosti in notranji vodni pufrski sistem, ki skupaj ohranjata doksorubicinijev klorid inkapsuliran, dokler liposomi krožijo v krvi.
Caelyx is administered as an intravenous infusion.
Zdravilo Caelyx se uporablja v obliki intravenske infuzije.
The dosage can be increased to full dose for subsequent cycles if tolerated.
Odmerek smete v naslednjih krogih povečati do polnega odmerka, če bolnik to dobro prenaša.
If a test result indicates possible cardiac injury associated with Caelyx therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury.
Če izvid pokaže možno okvaro srca v povezavi z zdravljenjem z zdravilom Caelyx, morate skrbno pretehtati koristnost nadaljnjega zdravljenja v primerjavi s tveganjem za okvaro miokarda.
To minimise the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute.
Da bi kar najbolj zmanjšali nevarnost infuzijskih reakcij, hitrost dajanja začetnega odmerka ne sme preseči 1 mg/minuto.
Caelyx is also used to treat cancer of the ovary.
Zdravilo Caelyx se uporablja tudi za zdravljenje raka jajčnikov.
Guidelines for Caelyx dose modification secondary to these adverse effects are provided in the tables below.
Smernice za prilagajanje odmerka zdravila Caelyx v primeru pojava teh neželenih učinkov so podane v spodnjih preglednicah.
Many patients treated with Caelyx have baseline myelosuppression due to such factors as their pre-existing HIV disease or numerous concomitant or previous medications, or tumours involving bone marrow.
Številni bolniki, zdravljeni z zdravilom Caelyx, imajo mielosupresijo že na začetku zdravljenja zaradi dejavnikov, kot so npr. obstoječa okužba s HIV, številna sočasna ali predhodno uporabljena zdravila ali pa infiltracija kostnega mozga.
Caelyx contains less than 1 mmol sodium (23 mg) per dose, that is to say ‘essentially sodium-free'.
Zdravilo Caelyx vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
The table for haematological toxicity (Table 3) provides the schedule followed for dose modification in clinical trials in the treatment of patients with breast or ovarian cancer only.
Preglednica za hematološko toksičnost (Preglednica 3) podaja shemo za prilagajanje odmerka, uporabljeno v kliničnih študijah le pri zdravljenju bolnic z rakom dojk ali rakom jajčnikov.
If the patient experiences early symptoms or signs of infusion reaction (see sections 4.4 and 4.8), immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
Če se pojavijo zgodnji simptomi ali znaki infuzijske reakcije (glejte poglavji 4.4. in 4.8), infuzijo takoj prekinite, bolniku dajte ustrezno premedikacijo (antihistaminik in/ali kratkodelujoči kortikosteroid) in nato nadaljujte infuzijo z manjšo hitrostjo.
5 How to store Caelyx Contents of the pack and other information
Shranjevanje zdravila Caelyx Vsebina pakiranja in dodatne informacije
Similar dermal lesions, which are described as palmar-plantar erythrodysesthesia were also observed in patients after long-term intravenous infusion (see section
Podobne kožne lezije, ki jih opisujejo kot palmo-plantarno eritrodizestezijo, so opažali tudi pri bolnikih po dolgotrajnih intravenskih infuzijah (glejte poglavje 4.8).
Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells.
Zdravilo Caelyx vsebuje zdravilno učinkovino, ki deluje tako, da selektivno uničuje rakave celice.
Treatment will include administration of antibiotics, platelet cell transfusions, use of factors which stimulate production of white blood cells and symptomatic treatment of mouth sores.
Zdravljenje bo vključevalo uporabo obsega antibiotikov, transfuzij trombocitov, dajanje faktorjev, ki spodbujajo nastajanje levkocitov in simptomatsko zdravljenje razjed v ustih.
Ovarian cancer n=512
Rak jajčnikov n=512
Toxicity grade at current assessment
Trenutna ocena stopnje toksičnosti
If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.
Če se pri bolniku pojavijo zgodnji simptomi ali znaki infuzijske reakcije, infuzijo takoj prekinite, mu dajte ustrezno premedikacijo (antihistaminik in/ali kratkodelujoči kortikosteroid) in nato infuzijo nadaljujte z manjšo hitrostjo.
The active ingredient of Caelyx is doxorubicin hydrochloride, a cytotoxic anthracycline antibiotic obtained from Streptomyces peucetius var. caesius.
Učinkovina zdravila Caelyx je doksorubicinijev klorid, ki je citotoksičen antraciklinski antibiotik, pridobljen iz Streptomyces peucetius var. caesius.
EU/1/96/011/001 (1 vial) EU/1/96/011/002 (10 vials)
EU/1/96/011/001 (1 viala) EU/1/96/011/002 (10 vial)
After dilution: - Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Po razredčenju: - Zdravilo je med uporabo kemično in fizikalno stabilno 24 ur pri temperaturi 2 °C do 8 °C.
EU/1/96/011/003 (1 vial) EU/1/96/011/004 (10 vials)
EU/1/96/011/003 (1 viala) EU/1/96/011/004 (10 vial)
Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
- Zdravilo Caelyx lahko uporabljate kot sistemsko kemoterapijo prve izbire ali kot kemoterapijo druge izbire pri bolnikih, ki imajo z aidsom povezan Kaposijev sarkom in bolezen, ki je napredovala kljub predhodni kombinirani sistemski kemoterapiji z vsaj dvema od naslednjih citostatikov: alkaloid vinke, bleomicin in standardni doksorubicin (ali kakšen drug antraciklin) ter pri tistih bolnikih, ki so slabo prenašali takšno predhodno kombinirano sistemsko kemoterapijo.
Decrease dose by 25%; return to 4 week interval or withdraw patient per physician's assessment
Zmanjšajte odmerek za 25%; vrnite se na 4-tedenski razmik ali prenehajte s to terapijopo presoji zdravnika
At cumulative doses greater than 450 mg/m2 there were no cardiac events with Caelyx.
Pri kumulativnih odmerkih, večjih od 450 mg/m2, ni bilo pri zdravilu Caelyx nobenih kardialnih sopojavov.
The plasma pharmacokinetics of Caelyx in humans differ significantly from those reported in the literature for standard doxorubicin hydrochloride preparations.
Farmakokinetika zdravila Caelyx v plazmi pri ljudeh se bistveno razlikuje od farmakokinetike, opisane v literaturi za standardne pripravke doksorubicinijevega klorida.
Infusion-associated reactions
Infuzijske reakcije
Respiratory undesirable effects commonly occurred in clinical studies of Caelyx and may be related to opportunistic infections (OI's) in the AIDS population.
Neželeni učinki na dihala so bili v kliničnih študijah z zdravilom Caelyx pogosti in bi lahko bili povezani z oportunističnimi okužbami pri bolnikih z aidsom.
Vascular disorders uncommon venous thromboembolism, including thrombophlebitis, venous thrombosis and pulmonary embolism
Žilne bolezni občasni venski trombembolizem, vključno s tromboflebitisom, vensko trombozo in pljučno embolijo
Based on the review of the safety data of pegylated liposomal doxorubicin hydrochloride (Caelyx), a signal of lichenoid keratosis was detected with a total of 10 cases reported.
Na podlagi pregleda podatkov o varnosti doksorubicinijevega klorida v pegiliranem liposomskem pripravku (zdravilo Cealyx), so pri 10 poročanih primerih ugotovili varnostni signal za lihenoidno keratozo.
Breast cancer/Ovarian cancer Caelyx is administered intravenously at a dose of 50 mg/m once every 4 weeks for as long as the disease does not progress and the patient continues to tolerate treatment.
Zdravilo Caelyx se daje intravensko v odmerku 50 mg/m2 enkrat na vsake 4 tedne, dokler bolezen ne napreduje in bolnica dobro prenaša zdravljenje.
A phase III randomised study of Caelyx versus doxorubicin in patients with metastatic breast cancer was completed in 509 patients.
Randomizirano raziskavo faze III, v kateri so zdravilo Caelyx primerjali s standardnim doksorubicinom pri bolnikih z metastatskim rakom dojk, je zaključilo 509 bolnikov.
The use of any diluent other than 5% (50 mg/ml) glucose solution for infusion, or the presence of any bacteriostatic agent such as benzyl alcohol may cause precipitation of Caelyx.
Uporaba katerega koli drugega vehikla kot 5% (50 mg/ml) raztopine glukoze za infundiranje oz. prisotnost kakršnegakoli bakteriostatika, npr. benzil alkohola, lahko povzroči obarjanje zdravila Caelyx.
Do not dose this cycle if before day 4; if after day 4 reduce next dose by 25% in the following cycles if bortezomib is reduced for haematologic toxicity.
V tem krogu ne infundirajte zdravila, če se to pojavi pred 4. dnevom, po 4. dnevu pa bolniku zmanjšajte naslednji odmerek za 25% v naslednjih krogih, če je bil odmerek bortezomiba zmanjšan zaradi hematološke toksičnosti.
There was a significant improvement in the primary endpoint of time to progression (TTP) for patients treated with combination therapy of Caelyx plus bortezomib compared to patients treated with bortezomib monotherapy as indicated by a risk reduction (RR) of 35% (95% CI: 21-47%), p < 0.0001, based on 407 TTP events.
Opazno je bilo bistveno izboljšanje kar zadeva primarni končni rezultat, ki je bil čas do napredovanja bolezni (TTP) pri bolnikih, ki so bili zdravljeni s kombinirano terapijo z zdravilom Caelyx in bortezomibom, v primerjavi s tistimi, ki so prejemali bortezomib v monoterapiji; to so ugotovili na podlagi zmanjšanja tveganja (RR) za 35% (95% interval zaupanja IZ; od 21 do 47%), p < 0,0001 na osnovi 407 TTP dogodkov.
Maximum plasma concentration* (µg/ml) Plasma clearance (l/h/m Volume of distribution (l/m AUC (µg/mlh)
Največja koncentracija v plazmi* (μg/ml) Plazemski očistek (l/h/m Volumen porazdelitve (l/m AUC (μg/ml∙h) λ1 razpolovni čas (h) λ2 razpolovni čas (h)
Caelyx is also used in combination with another medicine, bortezomib, to treat multiple myeloma, a cancer of the blood in patients who have received at least 1 prior therapy.
Zdravilo Caelyx uporabljamo tudi v kombinaciji z drugim zdravilom, bortezomibom, za zdravljenje diseminiranega plazmocitoma, vrste krvnega raka pri bolnikih, ki so že prejeli najmanj 1 vrsto predhodnega zdravljenja.
Caelyx contains soya oil and sodium
Zdravilo Caelyx vsebuje sojino olje in natrij
In studies performed after the repeated administration of Caelyx to rats and dogs, serious dermal inflammations and ulcer formations were observed at clinically relevant dosages.
V raziskavah večkratnega dajanja zdravila Caelyx podganam in psom so pri klinično relevantnih odmerkih opažali resna kožna vnetja in nastajanje razjed.
- Partially used vials must be discarded.
- Delno porabljene viale morate zavreči.
The most frequently reported (medicine-related treatment-emergent) adverse events in combination therapy (Caelyx + bortezomib) were nausea (40%), diarrhoea (35%), neutropaenia (33%), thrombocytopaenia (29%), vomiting (28%), fatigue (27%), and constipation (22%).
Najpogosteje poročani neželeni učinki (ki so bili povezani s prejemanjem zdravil in so se pojavili med zdravljenjem z njimi) pri zdravljenju z zdravilom Caelyx v kombinaciji z bortezomibom so bili slabost (40%), driska (35%), nevtropenija (33%), trombocitopenija (29%), bruhanje (28%), utrujenost (27%) in zaprtje (22%).
Mucositis (23% vs. 13%; grade 3/4 4% vs. 2%), and stomatitis (22% vs. 15%; grade 3/4 5% vs. 2%) were reported more commonly with Caelyx than with doxorubicin.
O mukozitisu (23% in 13%, 3. do 4. stopnja 4% in 2%) in stomatitisu (22% in 15%, 3. do 4. stopnja 5% in 2%) so poročali pogosteje pri zdravilu Caelyx kot pri standardnem doksorubicinu.
Persistent severe myelosuppression, may result in superinfection or haemorrhage.
Dolgotrajna huda mielosupresija lahko vodi do sekundarnih okužb ali krvavitev.
The haematological toxicity for ovarian cancer patients is less severe than in the AIDS-KS setting (see section for ovarian cancer patients above).
Hematološki toksični učinki pri bolnicah z rakom jajčnikov so manj resni kot pri bolnikih, ki imajo z aidsom povezan Kaposijev sarkom (glejte poglavje o bolnicah z rakom jajčnikov).
Stomatitis was reported more frequently in the combination therapy group (16%) than in the monotherapy group (3%), and most cases were grade 2 or less in severity.
O stomatitisu so poročali pogosteje v skupini, ki je prejemala kombinirano zdravljenje (16%) kot v skupini, ki je prejamala monoterapijo (3%), in večina primerov je bila po jakosti 2. stopnje ali manj.
The dose is repeated as long as you respond satisfactorily and tolerate treatment.
Infuzije bodo ponavljali tako dolgo, dokler se boste zadovoljivo odzivali na zdravljenje in ga boste dobro prenašali.
Guidelines for Caelyx dose modification
Smernice za prilagajanje odmerka zdravila Caelyx
Animal studies indicate that administration of doxorubicin hydrochloride as a liposomal formulation reduces the potential for extravasation injury.
Raziskave pri živalih kažejo, da uporaba liposomskega pripravka doksorubicinijevega klorida zmanjša nevarnost ekstravazacijske poškodbe.
Because of the potential for bone marrow suppression, periodic blood counts must be performed frequently during the course of Caelyx therapy, and at a minimum, prior to each dose of Caelyx.
Zaradi nevarnosti mielosupresije morate med zdravljenjem z zdravilom Caelyx pogosto in redno opravljati preiskave krvne slike, vsaj pred vsakim odmerkom zdravila.
The pharmacokinetic parameters of Caelyx (primarily representing pegylated liposomal doxorubicin hydrochloride and low levels of unencapsulated doxorubicin hydrochloride) observed after the 20 mg/m2 doses are presented in
Farmakokinetični parametri zdravila Caelyx (v prvi vrsti za pegiliran liposomski doksorubicinijev klorid in majhno koncentracijo neinkapsuliranega doksorubicinijevega klorida), ugotovljeni po odmerku 20 mg/m2, so prikazani v
Taking into account the PRAC Assessment Report on the PSUR(s) for doxorubicin, the scientific conclusions of the CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za doksorubicin, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
AIDS-related KS program Clinical studies on AIDS-KS patients treated at 20 mg/m2 with Caelyx show that myelosuppression was the most frequent undesirable effect considered related to Caelyx occurring very commonly (in approximately one-half of the patients).
Raziskave pri bolnikih, ki imajo z aidsom povezan Kaposijev sarkom Klinične študije pri teh bolnikih z zdravilom Caelyx v odmerku 20 mg/m2 kažejo, da je najpogostnejši neželeni učinek, povezan z zdravilom, mielosupresija in se pojavlja zelo pogosto (pojavila se je pri približno polovici bolnikov).
If you are being treated for multiple myeloma, and have already received at least 1 prior therapy, Caelyx will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1 hour intravenous infusion on day 4 of the bortezomib 3 week regimen immediately after the bortezomib infusion.
Če se zdravite zaradi diseminiranega plazmocitoma in ste že prejeli najmanj 1 vrsto predhodnega zdravljenja, vam bodo zdravilo Caelyx dali v odmerku 30 mg na kvadratni meter telesne površine (ta pa je odvisna od vaše telesne višine in mase) v obliki enourne intravenske infuzije na 4. dan 3-tedenske sheme zdravljenja z bortezomibom, in sicer takoj po infuziji bortezomiba.
Aspartate aminotransferase increased, ejection fraction decreased, blood creatinine increased, alanine aminotransferase increased
Preiskave pogosti zmanjšana telesna masa zvišana vrednost aspartat aminotransferaze, zmanjšana iztisna frakcija srca, zvišana vrednost kreatinina v krvi, zvišana vrednost alanin aminotransferaze
Very rare cases of secondary oral cancer have been reported in patients with long-term (more than one year) exposure to Caelyx or those receiving a cumulative Caelyx dose greater than 720 mg/m2.
O zelo redkih primerih sekundarnega raka v ustni votlini so poročali pri bolnikih, ki so bili dalj časa (več kot eno leto) izpostavljeni zdravilu Caelyx ali pri bolnikih, ki so prejemali celokupni odmerek zdravila Caelyx, ki je bil večji od 720 mg/m2.
Do not administer Caelyx as a bolus injection or undiluted solution.
Zdravila Caelyx ne smete dati v obliki bolusne injekcije ali nerazredčene raztopine.
The doxorubicin hydrochloride in Caelyx is enclosed in tiny spheres called pegylated liposomes which help to deliver the medicinal product from the blood stream to the cancerous tissue rather than healthy normal tissue.
Doksorubicinijev klorid se v zdravilu Caelyx nahaja v obliki zelo majhnih kroglic, pegiliranih liposomov, ki pomagajo, da pride zdravilo iz krvi predvsem v rakavo tkivo, in čimmanj v zdravo normalno tkivo.
Redose unless patient has experienced a previous grade 3 or 4 stomatitis in which case wait an additional week
Ponovite odmerek, razen če ni bolnik prej imel stomatitisa 3. ali 4. stopnje; v tem primeru počakajte še en teden.
In contrast, 10 of 48 doxorubicin subjects who had cardiac toxicity by LVEF criteria also developed signs and symptoms of CHF.
Nasprotno pa so se pri 10 od 48 bolnikov, ki so prejemali standardni doksorubicin s kardiotoksičnostjo po merilih LVEF pojavili tudi znaki in simptomi kongestivnega srčnega popuščanja.
Caelyx is available in glass vials as a single pack or packs of ten vials.
Caelyx je na voljo v pakiranju z eno ali desetimi vialami.
Caelyx should only be administered under the supervision of a qualified oncologist specialised in the administration of cytotoxic agents.
Zdravilo Caelyx smete uporabljati le pod nadzorom usposobljenega onkologa, specializiranega za dajanje citotoksičnih zdravil.
Nausea and vomiting were reported more frequently in the combination therapy group (40% and 28%) than in the monotherapy group (32% and 15%) and were mostly grade 1 and 2 in severity.
O slabosti in bruhanju so poročali pogosteje v skupini za kombinirano zdravljenje (40% in 28%) kot v skupini za monoterapijo (32% in 15%), po jakosti pa sta bila večinoma 1. ali 2. stopnje.
The most frequently observed OI's in clinical studies were candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumonia, and mycobacterium avium complex.
V kliničnih študijah so bile najpogostnejše oportunistične okužbe kandidiaza, okužba s citomegalovirusom, herpes simpleks, pljučnica zaradi okužbe s Pneumocystis carinii in kompleks Mycobacterium avium.
Psychiatric disorders uncommon confusion
Psihiatrične motnje občasni zmedenost
Women of child-bearing potential must be advised to avoid pregnancy while they or their male partner are receiving Caelyx and in the six months following discontinuation of Caelyx therapy (see section
Ženskam v rodni dobi morate svetovati, naj ne zanosijo, medtem ko same ali njihov partner prejemajo zdravilo Caelyx in še šest mesecev po prenehanju zdravljenja z njim (glejte poglavje 5.3).
The following common adverse events were reported more often with doxorubicin than with Caelyx: nausea (53% vs. 37%; grade 3/4 5% vs. 3%), vomiting (31% vs. 19%; grade 3/4 4% vs. less than 1%), any alopecia (66% vs. 20%), pronounced alopecia (54% vs.7%), and neutropaenia (10% vs. 4%; grade 3/4 8% vs.
O naslednjih pogostih neželenih učinkih so poročali pogosteje pri standardnem doksorubicinu kot pri zdravilu Caelyx: navzea (53% za standardni doksorubicin in 37% za zdravilo Caelyx, za jakost 3. do 4. stopnje pa 5% in 3%), bruhanje (31% in 19%; 3. do 4. stopnja 4% in manj kot 1%), kakršna koli alopecija (66% in 20%), izrazita alopecija (54% in 7%) in nevtropenija (10% in 4%, 3. do 4. stopnja 8% in 2%).