natgillin/translations-raw huggingface dataset:
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:
Dermal toxicity 
Dermalna toksičnost
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%).
A similar incidence of infusion reactions (12.4%) and treatment discontinuation (1.5%) was observed in the breast cancer program. 
Pri bolnicah z rakom dojk so poročali o podobni incidenci infuzijskih reakcij (12,4%) in prekinitve zdravljenja (1,5%).
Contact your doctor immediately if: - you get reddening painful skin on your hands and feet; - you get painful reddening of the skin and/or blisters on the body or in the mouth; - you get heart problems; - you get mouth sores; - you develop a fever or any other sign of an infection; - you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or coughing; - you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain which gets worse when you stand or walk. 
Nemudoma se posvetujte z zdravnikom, če: - vam koža na dlaneh in stopalih pordi in vas boli - se pojavi boleča pordelost kože in/ali mehurji na telesu ali v ustih - se pojavijo težave s srcem - se pojavijo razjede v ustih - se vam zviša telesna temperatura ali se pojavi kakšen drug znak okužbe - se pri vas nenadno pojavijo težave z dihanjem ali ostre bolečine v prsih, ki se lahko poslabšajo z globokim dihanjem ali kašljanjem - se pojavi otekanje, občutek toplote ali občutljivost v mehkih tkivih nog včasih skupaj z bolečino, ki se poslabša, kadar stojite ali med hojo
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 (see section 4.4). 
O 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 skupni odmerek zdravila Caelyx, ki je bil večji od 720 mg/m2 (glejte poglavje 4.4).
In repeat dose studies conducted in animals, the toxicity profile of Caelyx appears very similar to that reported in humans who receive long-term infusions of standard doxorubicin hydrochloride. 
V raziskavah pri živalih z večkratnimi odmerki je bil toksični profil zdravila Caelyx videti zelo podoben profilu pri ljudeh, ki so dlje časa prejemali infuzije standardnega doksorubicinijevega klorida.
A study has shown that Caelyx at a single intravenous dose of over twice the clinical dose produces renal toxicity in monkeys. 
Študija je pokazala, da je zdravilo Caelyx v enkratnem intravenskem odmerku, večjem od dvakratnika kliničnega odmerka, toksično za ledvice pri opicah.
Do not use this medicine if you notice that it shows evidence of precipitation or any other particulate matter. 
Tega zdravila ne uporabljajte, če opazite znake obarjanja ali če vsebuje zdravilo kakršnekoli druge vidne delce.
Eye disorders common retinitis 
Očesne bolezni pogosti retinitis
Acute overdosing with doxorubicin hydrochloride worsens the toxic effects of mucositis, leukopaenia and thrombocytopaenia. 
Akutno preveliko odmerjanje doksorubicinijevega klorida poslabša toksične učinke: mukozitis, levkopenijo in trombopenijo.
If tolerated, the infusion was completed over the next hour for a total infusion time of 90 minutes. 
Če še vedno ni bilo težav, so infuzijo dokončali v naslednji uri, da je bil skupni čas infundiranja 90 minut.
In contrast to the experience in patients with breast cancer or ovarian cancer, myelosuppression appears to be the dose-limiting adverse event in patients with AIDS-KS (see section 4.8). 
V nasprotju z izkušnjami pri bolnicah z rakom dojk ali rakom jajčnikov pa kaže, da je pri bolnikih, ki imajo z aidsom povezan Kaposijev sarkom, ravno mielosupresija tisti neželeni učinek, ki omejuje odmerek (glejte poglavje 4.8).
If you are being treated for breast cancer or ovarian cancer, Caelyx will be administered at a dose of 50 mg per square metre of your body surface area (based on your height and weight). 
Če se zdravite zaradi raka dojk ali jajčnikov, boste zdravilo Caelyx prejeli v odmerku 50 mg na kvadratni meter telesne površine (izračunane na podlagi vaše telesne višine in mase).
Of the 418 patients treated with Caelyx 50 mg/m2/cycle, and having a baseline measurement of left ventricular ejection fraction (LVEF) and at least one follow-up measurement assessed by MUGA scan, 88 patients had a cumulative anthracycline dose of > 400 mg/m2, an exposure level associated with an increased risk of cardiovascular toxicity with conventional doxorubicin. 
Pri 418 bolnikih, zdravljenih z zdravilom Caelyx v odmerku 50 mg/m2 na krog, pri katerih so opravili meritev vrednosti iztisnega deleža levega prekata na začetku raziskave in vsaj eno kontrolno meritev s slikanjem MUGA, jih je 88 prejelo kumulativni odmerek antraciklina > 400 mg/m2- to je količina, ki je bila pri standardnih pripravkih doksorubicina povezana z večjim tveganjem za pojav kardiovaskularne toksičnosti.
If you are being treated for Kaposi'sarcoma, Caelyx will be administered at a dose of 20 mg per square metre of your body surface area (based on your height and weight). 
Če se zdravite zaradi Kaposijevega sarkoma, boste zdravilo Caelyx prejeli v odmerku 20 mg na kvadratni meter vaše telesne površine (izračunane na podlagi vaše telesne višine in mase).
Decreased testicular weights and hypospermia were present in rats after repeat doses 0.25mg/kg/day and diffuse degeneration of the seminiferous tubules and a marked decrease in spermatogenesis were observed in dogs after repeat doses of 1 mg/kg/day (see section 4.6). 
Pri podganah sta se po večkratnih odmerkih  0,25 mg/kg/dan pojavili zmanjšana teža mod in hipospermija, pri psih pa so po večkratnih odmerkih 1 mg/kg/dan ugotavljali difuzno degeneracijo semenskih kanalov in izrazito zmanjšanje spermatogeneze (glejte poglavje 4.6).
No dosage adjustments. 
Prilagoditev odmerka zdravila ni potrebna .
* for more information on bortezomib dosing and dosage adjustment, see the SPC for bortezomib 
*za dodatne informacije o odmerjanju bortezomiba in prilagoditvi odmerka glejte povzetek glavnih značilnosti zdravila za bortezomib
Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the suspension of Caelyx therapy. 
Prehodne elektrokardiografske spremembe, npr. sploščenje valov T, znižanje veznice ST in benigne motnje srčnega ritma, ne zahtevajo nujno prenehanja zdravljenja z zdravilom Caelyx.
Partially used vials must be discarded. 
Delno porabljene viale morate zavreči.
No formal medicinal product interaction studies have been performed with Caelyx, although phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological malignancies. 
Formalnih raziskav medsebojnega delovanja zdravila Caelyx z drugimi zdravili ni bilo, le pri bolnicah z ginekološkimi malignomi so opravili kombinirane raziskave faze II s konvencionalnimi kemoterapevtiki.
Caelyx contains soya oil. 
Zdravilo Caelyx vsebuje sojino olje.
Caelyx can be administered to patients with liver metastases with concurrent elevation of bilirubin and liver enzymes up to 4 x the upper limit of the normal range. 
Zdravilo Caelyx lahko uporabite pri bolnikih z metastazami v jetrih in s sočasnim povečanjem koncentracije bilirubina in jetrnih encimov do 4-kratne zgornje meje normalnega razpona vrednosti.
Do not dose this cycle if before day 4; if after day 4, reduce next dose by 25%. 
V tem krogu ne infundirajte zdravila, če se to pojavi pred 4. dnevom, po 4. dnevu pa bolniku zmanjšajte naslednji odmerek za 25%.
Skin and subcutaneous tissue disorders Very common 
Bolezni kože in podkožja zelo pogosti
It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ml) glucose to achieve further dilution and minimise the risk of thrombosis and extravasation. 
Priporočljivo je, da je infuzijska linija za zdravilo Caelyx prek stranskega nastavka priključena na intravensko infuzijo 5% (50 mg/ml) glukoze, da zagotovite dodatno razredčenje in na najmanjšo možno mero zmanjšate nevarnost tromboze in ekstravazacije.
The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the Caelyx plus bortezomib combination therapy patients. 
Za bolnike, zdravljene samo z bortezomibom, je bilo mediano OS 30,8 mesecev (95% IZ; 25,2-36,5 mesecev) za bolnike, zdravljene z zdravilom Caelyx v kombinaciji z bortezomibom, pa 33,0 mesecev (95% IZ; 28,9-37,1 meseca).
For multiple myeloma patients treated with Caelyx in combination with bortezomib who experience PPE or stomatitis, the Caelyx dose should be modified as described in Table 1 and 2 above respectively. 
Pri bolnikih z diseminiranim plazmocitomom, ki se zdravijo z zdravilom Caelyx v kombinaciji z bortezomibom in pri katerih se pojavi palmarno-plantarna eritrodisestezija (PPE) oziroma stomatitis, je treba odmerek zdravila Caelyx prilagoditi, kot je opisano v Preglednicah 1 in 2 zgoraj.
More specific methods for the evaluation and monitoring of cardiac functions as compared to ECG are a measurement of left ventricular ejection fraction by echocardiography or preferably by Multigated 
Bolj specifičen način ocenjevanja in spremljanja delovanja srca od EKG je merjenje iztisnega deleža levega prekata z ehokardiografijo ali, še bolje, z multiplo proženo angiografijo (Multiple Gated Angiography - MUGA).
Pharmacokinetic parameters in Caelyx-treated AIDS-KS patients Mean + standard error 
Farmakokinetični parametri zdravila Caelyx pri bolnikih s Kaposijevim sarkomom, povezanim z aidsom Srednja vrednost ± standardna napaka
Studies in rabbits have shown that the cardiotoxicity of Caelyx is reduced compared with conventional doxorubicin hydrochloride preparations. 
Raziskave pri kuncih so pokazale, da je kardiotoksičnost zdravila Caelyx manjša kot pri standardnih pripravkih doksorubicinijevega klorida.
Adverse drug reactions identified during the post-marketing experience with Caelyx are described in Table 9. 
Neželeni učinki, ugotovljeni v obdobju trženja zdravila Caelyx, so opisani v Preglednici 9.
Very common side effects (may affect more than 1 in 10 people) - redness, swelling and sores on the palms of your hands and feet. 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - pordelost ter rane ali otekanje dlani in stopal.
The cardiac safety profile for the dosing schedule recommended for both breast and ovarian cancer (50 mg/m 2) is similar to the 20 mg/m 2 profile in patients with AIDS-KS (see section 4.8). 
Kardialni varnostni profil zdravila pri režimu odmerjanja, priporočenem za rak dojk in rak jajčnikov (50 mg/m 2), je podoben kot pri odmerjanju 20 mg/m 2 za bolnike, ki imajo z aidsom povezan
Caelyx will be given to you by your doctor in a drip (infusion) into a vein. 
Zdravnik vam bo zdravilo Caelyx dal v (kapalni) infuziji v veno.
Caelyx is used to treat cancer of the breast in patients at risk for heart problems. 
Zdravilo Caelyx uporabljamo za zdravljenje raka dojk pri bolnicah, s tveganjem zaradi težav s srcem.
In patients with AIDS-KS, infusion-associated reactions, were characterised by flushing, shortness of breath, facial oedema, headache, chills, back pain, tightness in the chest and throat and/or hypotension and can be expected at the rate of 5% to 10%. 
Pri bolnikih s Kaposijevim sarkomom, povezanim z aidsom, so bili za infuzijske reakcije značilni rdečica, težko dihanje, edem obraza, glavobol, mrzlica, bolečine v hrbtu, tiščanje v prsih in žrelu in/ali hipotenzija in te lahko pričakujete v 5 do 10% primerov.
Type I glass vials, each with a siliconised grey bromobutyl stopper, and an aluminium seal, with a deliverable volume of 10 ml (20 mg) or 25 ml (50 mg). 
Viale (steklo tipa I) s silikoniziranim sivim brombutilnim zamaškom in aluminijasto zaporko, ki vsebujejo po 10 ml (20 mg) ali 25 ml (50 mg) uporabnega volumna.
Pruritus, papular rash, allergic dermatitis, erythema, skin hyperpigmentation, petechiae, alopecia, medicine eruption 
pruritus, papulozni izpuščaj, alergijski dermatitis, eritem, hiperpigmentacija kože, petehije, alopecija, medikamentozni izpuščaj
Caelyx 2 mg/ml concentrate for solution for infusion 
Caelyx 2 mg/ml koncentrat za raztopino za infundiranje
If tolerated, the infusion may then be completed over the next hour for a total infusion time of 90 minutes. 
Če to še vedno dobro prenaša, lahko infuzijo dokončate v naslednji uri, da bo skupni čas infundiranja 90 minut
How much Caelyx is given 
Koliko zdravila Caelyx boste prejeli
Sepsis related to leukopaenia was observed infrequently (< 1%). 
V redkih primerih so opažali sepso, povezano z levkopenijo (< 1%).
The recommended dose of Caelyx for AIDS-KS patients is 20 mg/m2 every two-to-three weeks. 
Priporočeni odmerek zdravila Caelyx za bolnike, ki imajo z aidsom povezani Kaposijev sarkom, je 20 mg/m2 na vsaka dva do tri tedne.
Treatment of acute overdose of the severely myelosuppressed patient consists of hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis. 
Zdravljenje akutnega predoziranja pri močno mielosuprimiranih bolnikih obsega bolnišnično zdravljenje z antibiotiki, transfuzijami trombocitov in granulocitov ter simptomatskim zdravljenjem mukozitisa.
512 patients with ovarian cancer (a subset of 876 solid tumour patients) were treated with Caelyx at a dose of 50 mg/m2 in clinical trials. 
V kliničnih preskušanjih so 512 bolnic z rakom jajčnikov (podskupina 876 bolnic s solidnimi tumorji) zdravili z zdravilom Caelyx v odmerku 50 mg/m2.
Sepsis related to leukopaenia was rarely (< 1%) observed. 
Z levkopenijo povezano sepso so opazili redko (< 1%).
A phase III randomised, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients. 
Pri 646 bolnikih je bila opravljena randomizirana, odprta, multicentrična študija faze III pri vzporednih skupinah za primerjavo varnosti in učinkovitosti kombinirane terapije z zdravilom Caelyx in bortezomibom in monoterapije z bortezomibom pri bolnikih z diseminiranim plazmocitomom, ki so prejeli najmanj eno predhodno terapijo in pri katerih bolezen ni napredovala med prejemanjem antraciklinske terapije.
The treatments were similar in the sub-group of patients with platinum-refractory disease: HR of 1.069 (95% CI: 0.823; 1.387), p=0.618. 
Terapija je bila podobna v podskupini bolnic z rakom, ki se ni odzival na platinsko kemoterapijo: razmerje med tveganji (HR) je bilo 1,069 (95% IZ; 0,823, 1,387), p=0,618.
Neutropaenia, thrombocytopaenia, and anaemia were the most frequently reported haematologic events reported with both combination therapy of Caelyx plus bortezomib and bortezomib monotherapy. 
Nevtropenija, trombocitopenija in anemija so bili najpogosteje poročani hematološki učinki tako pri kombinirani terapiji z zdravilom Caelyx in bortezomibom kot pri monoterapiji z bortezomibom.
If this change occurs, the most definitive test for anthracycline myocardial injury, i.e., endomyocardial biopsy, must be considered. 
Če se pojavi ta sprememba, premislite o potrebi po endomiokardni biopsiji, ki je najbolj dokončna preiskava za ugotovitev okvare miokarda zaradi antraciklinov.
100 out of 929 patients (10.8%) with solid tumours were described as having an infusion-associated reaction during treatment with Caelyx as defined by the following Costart terms: allergic reaction, anaphylactoid reaction, asthma, face oedema, hypotension, vasodilatation, urticaria, back pain, chest pain, chills, fever, hypertension, tachycardia, dyspepsia, nausea, dizziness, dyspnoea, pharyngitis, rash, pruritus, sweating, injection site reaction and medicinal product interaction. 
100 od 929 bolnikov (10,8%) s solidnimi tumorji je imelo med zdravljenjem z zdravilom Caelyx infuzijsko reakcijo, kot jo opredeljujejo naslednji izrazi Costart: alergijska reakcija, anafilaktoidna reakcija, astma, edem obraza, hipotenzija, vazodilatacija, urtikarija, bolečine v hrbtu, bolečine v prsih, mrzlica, zvišana telesna temperatura, hipertenzija, tahikardija, dispepsija, slabost, omotica, dispneja, faringitis, izpuščaj, srbenje, znojenje, reakcija na mestu injekcije in medsebojno delovanje zdravil.
Subcutaneous tolerance studies indicate that Caelyx, as against standard doxorubicin hydrochloride, causes slighter local irritation or damage to the tissue after a possible extravasation. 
Raziskave subkutane tolerance za zdravilo kažejo, da zdravilo Caelyx v primerjavi s standardnim doksorubicinijevim kloridom po morebitni ekstravazaciji povzroči manj lokalnega draženja oz. poškodbe tkiva.
It is generally believed that inhibition of DNA, RNA and protein synthesis is responsible for the majority of the cytotoxic effects. 
Na splošno menijo, da je večina citotoksičnih učinkov posledica zavore sinteze DNA, RNA in beljakovin.
Common adverse events which led to treatment discontinuation of bortezomib and Caelyx included PPE, neuralgia, peripheral neuropathy, peripheral sensory neuropathy, thrombocytopaenia, decreased ejection fraction, and fatigue. 
Pogosti neželeni učinki, ki so vodili do ukinitve zdravljenja z bortezomibom in zdravilom Caelyx, so bili med drugim: PPE, nevralgija, periferna nevropatija, periferna senzorična nevropatija, trombocitopenija, zmanjšana iztisna frakcija srca in utrujenost.
MODIFICATION 
PRILAGODITEV
PPE was reported in 16% of multiple myeloma patients treated with Caelyx plus bortezomib combination therapy. 
O PPE so poročali pri 16% bolnikov z diseminiranim plazmocitomom, zdravljenih z zdravilom Caelyx v kombinaciji z bortezomibom.
For more detailed information on bortezomib dosing and dosage adjustments, see the SPC for bortezomib. 
Za podrobnejše informacije o odmerjanju bortezomiba in prilagajanju odmerka glejte povzetek glavnih značilnosti zdravila za bortezomib.