FrancophonIA/ELRC3.0 huggingface dataset:
English: 60 mg/m2/every 3 weeks) met the protocol-defined criteria for cardiac toxicity during treatment and/or follow-up.
Slovenian: 60 mg/m2 na vsake 3 tedne) izpolnjevalo kriterije kardiotoksičnosti po protokolu, med zdravljenjem in/ali med spremljanjem po zdravljenju.
English: Patients who suffer from these effects must avoid driving and operating machinery.
Slovenian: Bolniki, pri katerih se pojavita ta dva neželena učinka, naj ne vozijo in ne upravljajo s stroji.
English: It is not known whether Caelyx is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Caelyx izloča v mleko pri ljudeh.
English: Congestive heart failure due to cardiomyopathy may occur suddenly, without prior ECG changes and may also be encountered several weeks after discontinuation of therapy.
Slovenian: Kongestivno srčno popuščanje zaradi kardiomiopatije se lahko pojavi nenadoma in brez predhodnih EKG sprememb, lahko tudi več tednov po koncu zdravljenja.
English: Therefore, Caelyx should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Caelyx ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: - From a microbiological point of view, the product should be used immediately.
Slovenian: - Z mikrobiološkega stališča velja, da je treba zdravilo uporabiti takoj.
English: Grade 4 (requires parenteral or enteral support)
Slovenian: Stopnja 4 (potrebno parenteralno ali enteralno hranjenje)
English: Doses of bortezomib should be at least 72 hours apart.
Slovenian: Med zaporednimi odmerki bortezomiba mora preteči najmanj 72 ur.
English: Do not use with in-line filters.
Slovenian: Ne uporabljajte linij s filtri.
English: Temporarily stopping the infusion usually resolves these symptoms without further therapy.
Slovenian: Začasna prekinitev infundiranja običajno odpravi te simptome, ne da bi bilo potrebno dodatno zdravljenje.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih sprejetih posodobitvah RMP.
English: For all patients
Slovenian: Za vse bolnike
English: Treatment discontinuation of one or both agents due to adverse events was seen in 38% of patients.
Slovenian: Zdravljenje z enim ali obema zdraviloma so zaradi pojava neželenih učinkov ukinili pri 38% bolnikov.
English: In patients experiencing this event, it is generally seen after two or three cycles of treatment.
Slovenian: Ta učinek se pri bolnikih običajno pojavi po dveh ali treh krogih zdravljenja.
English: Caelyx should not be used in children and adolescents, because it is not known how the medicine will affect them.
Slovenian: Zdravila Caelyx se ne sme uporabljati pri otrocih in mladostnikih, ker vpliv zdravila pri tej populaciji ni znan.
English: Population based analysis demonstrates that age across the range tested (21-75 years) does not significantly alter the pharmacokinetics of Caelyx.
Slovenian: Populacijska analiza kaže, da starost v preskušanem razponu (21 do 75 let) bistveno ne spremeni farmakokinetike zdravila Caelyx.
English: Avoid intervals shorter than 10 days as medicinal product accumulation and increased toxicity cannot be ruled out.
Slovenian: Presledki naj ne bodo krajši od 10 dni, ker ni mogoče izključiti kopičenja zdravila in posledične povečane toksičnosti.
English: If the bilirubin is > 3.0 mg/dl, the first dose is reduced by 50%.
Slovenian: Če je koncentracija bilirubina > 3,0 mg/dl, prvi odmerek zmanjšajte za 50%.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Slovenian: Če se ne uporabi takoj, čas in pogoje shranjevanja pred uporabo z lastno odgovornostjo določi uporabnik na lastno odgovornost, vendar ne sme presegati 24 ur pri temperaturi 2 °C do 8 °C.
English: If Caelyx comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water.
Slovenian: Če pride zdravilo Caelyx v stik s kožo ali sluznico, jo takoj in temeljito umijte z milom in vodo.
English: Other less frequently (< 5%) observed undesirable effects included hypersensitivity reactions including anaphylactic reactions.
Slovenian: Med drugimi, redkejšimi (< 5%) neželenimi učinki so bile preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami.
English: The infusion may be given through a peripheral vein.
Slovenian: Infuzija lahko teče v periferno veno.
English: Treatment of patients for two-to-three months is recommended to achieve a therapeutic response.
Slovenian: Za doseganje terapevtskega odziva je priporočljivo bolnike zdraviti dva do tri mesece.
English: When Caelyx is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Slovenian: Pri samostojni uporabi zdravila Caelyx je verjetnost, da se bodo pojavili nekateri od teh učinkov, manjša, drugi pa se sploh ne pojavljajo.
English: Improvement usually occurs in one - two weeks, and in some cases, may take up to 4 weeks or longer for complete resolution.
Slovenian: Izboljšanje običajno nastopi v enem do dveh tednih, v nekaterih primerih pa lahko traja tudi do 4 tedne ali celo dlje, da izpuščaj popolnoma mine.
English: Section 4 of the package leaflet should be updated accordingly with the term “patches of skin thickening”.
Slovenian: Ustrezno je treba posodobiti tudi poglavje 4 Navodila za uporabo in vključiti izraz “zadebelitev delov kože”.
English: The dose is repeated every 4 weeks for as long as the disease does not progress and you are able to tolerate the treatment.
Slovenian: Odmerek je treba ponoviti na vsake 4 tedne, če bolezen ne napreduje in če dobro prenašate zdravljenje.
English: Decrease dose by 25%; return to 4 week interval
Slovenian: Zmanjšajte odmerek za 25%; vrnite se na 4-tedenski presledek
English: Growth factor support was required infrequently (< 5%) and transfusion support was required in approximately 15% of patients (see section 4.2).
Slovenian: Redko je bila potrebna podpora z rastnim faktorjem (< 5%), transfuzijo pa je potrebovalo približno 15% bolnic (glejte poglavje 4.2).
English: 75,000 - 150,000 Resume treatment with no dose reduction.
Slovenian: 75.000 - 150.000 Nadaljujte zdravljenje, ne da bi zmanjšali odmerek.
English: If the patient tolerates the first dose without an increase in serum bilirubin or liver enzymes, the dose for cycle 2 can be increased to the next dose level, i.e., if reduced by 25% for the first dose, increase to full dose for cycle 2; if reduced by 50% for the first dose, increase to 75% of full dose for cycle 2.
Slovenian: Če bolnik prenese prvi odmerek brez povečanja koncentracije serumskega bilirubina ali jetrnih encimov, lahko odmerek za 2. krog povečate na naslednjo odmerno raven, tj. če je bil prvi odmerek zmanjšan za 25%, ga v 2. krogu povečajte na polni odmerek; če je bil prvi odmerek zmanjšan za 50%, ga v 2. krogu povečajte na 75% polnega odmerka.
English: On the basis of the scientific conclusions for doxorubicin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing doxorubicin is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za doksorubicin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) doksorubicin nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
English: Caelyx must not be given by the intramuscular or subcutaneous route (see section 6.6).
Slovenian: Zdravila Caelyx ne smete dajati intramuskularno ali subkutano (glejte poglavje 6.6).
English: Grade 4 (diffuse or local process causing infectious complications, or a bedridden state or hospitalisation)
Slovenian: Stopnja 4 (difuzni ali lokalni procesi, ki povzročajo infekcijske zaplete; priklenjenost na posteljo ali bolnišnično zdravljenje)
English: These methods must be applied routinely before the initiation of Caelyx therapy and repeated periodically during treatment.
Slovenian: Takšen pregled je treba opraviti rutinsko še pred začetkom terapije z zdravilom Caelyx in ga med zdravljenjem redno ponavljati.
English: Other side effects Between infusions, the following may occur:
Slovenian: Drugi neželeni učinki Med posameznimi infuzijami se lahko pojavijo:
English: A similar, but less severe response was also noted in dogs treated with Caelyx and standard doxorubicin.
Slovenian: Podoben, a manj močan odziv je bil zabeležen tudi pri psih, zdravljenih z zdravilom Caelyx in standardnim doksorubicinom.
English: No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/min.
Slovenian: Podatki o farmakokinetiki zdravila pri bolnikih z očistkom kreatinina pod 30 ml/min niso na voljo.
English: However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Slovenian: Zmanjšanje kompleksa QRS pa velja za izrazitejši znak toksičnega učinka na srce.
English: Very rarely, convulsions also have been observed in relation to infusion reactions (see section 4.8).
Slovenian: Zelo redko se lahko v povezavi z infuzijskimi reakcijami pojavijo tudi konvulzije (glejte poglavje 4.8).
English: What Caelyx is and what it is used for
Slovenian: Kaj je zdravilo Caelyx in za kaj ga uporabljamo
English: Furthermore, only 1 patient (cumulative anthracycline dose of 944 mg/m2), discontinued study treatment because of clinical symptoms of congestive heart failure.
Slovenian: Poleg tega je le 1 bolnik (ki je dobil kumulativni odmerek antraciklina 944 mg/m2) prekinil zdravljenje v raziskavi zaradi kliničnih simptomov kongestivnega srčnega popuščanja.
English: For further instructions on preparation and special precautions for handling see section 6.6.
Slovenian: Za navodila o pripravi in posebnih previdnostnih ukrepih za ravnanje z zdravilom glejte poglavje 6.6.
English: Only 13 of these 88 patients (15%) had at least one clinically significant change in their LVEF, defined as an LVEF value less than 45% or a decrease of at least 20 points from baseline.
Slovenian: Le 13 od teh 88 bolnikov (15%) je imelo vsaj eno klinično pomembno spremembo LVEF, kar je bilo opredeljeno kot LVEF manjši od 45% ali zmanjšanje LVEF za vsaj 20 točk glede na vrednost na začetku raziskave.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Slovenian: Kemična in fizikalna stabilnost zdravila med uporabo je dokazana za čas 24 ur pri temperaturi od 2 °C do 8 °C.
English: Pegylated liposomes are small enough (average diameter of approximately 100 nm) to pass intact (extravasate) through defective blood vessels supplying tumours.
Slovenian: Pegilirani liposomi so dovolj majhni (povprečni premer je približno 100 nm), da nespremenjeni preidejo (ekstravazirajo) skozi okvarjene žile, ki oskrbujejo tumorje s krvjo.
English: Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding.
Slovenian: Anemija (zmanjšanje števila eritrocitov) lahko povzroči utrujenost, zmanjšano število trombocitov v krvi pa lahko poveča nevarnost za krvavitve.
English: If the drip stings or hurts while you are receiving a dose of Caelyx, tell your doctor immediately.
Slovenian: Če vam infuzija povzroča pekoč občutek ali bolečino, ko prejemate odmerek zdravila Caelyx, to nemudoma povejte zdravniku.
English: Haematological toxicity may require dose reduction or suspension or delay of therapy.
Slovenian: Zaradi hematoloških toksičnih učinkov je lahko potrebno zmanjšanje odmerka ali prekinitev oz. odložitev zdravljenja.
English: In the study in dogs, the occurrence and severity of these lesions was reduced by lowering the dose or prolonging the intervals between doses.
Slovenian: Pri psih so pojavljanje in stopnjo jakosti teh lezij omilili z zmanjšanjem odmerka ali s podaljšanjem časovnega razmika med odmerki.
English: Pharmacotherapeutic group: Cytotoxic agents (anthracyclines and related substances), ATC code: L01DB01.
Slovenian: Farmakoterapevtska skupina: citotoksična zdravila (antraciklinski antibiotiki in sorodne učinkovine), oznaka ATC: L01DB01.
English: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Slovenian: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgija
English: 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).
Slovenian: 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).
English: 0.96-3.85 l/m2) approximating the plasma volume.
Slovenian: (razpon od 0,96 do 3,85 l/m2), kar se približuje volumnu plazme.
English: Wait until ANC  1,500 and platelets  75,000; decrease dose by 25% or continue full dose with growth factor support.
Slovenian: 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.
English: - For treatment of AIDS-related Kaposi's sarcoma (KS) in patients with low CD4counts (< 200 CD4 lymphocytes/mm
Slovenian: - Z aidsom povezanega Kaposijevega sarkoma (KS) pri bolnikih z majhnim številom celic CD4 (< 200 limfocitov CD4/mm
English: All Severities n=318
Slovenian: Vse jakosti n=318
English: The frequency of lichenoid keratosis was determined as “rare” based on clinical trials.
Slovenian: Pogostnost lihenoidne keratoze je bila na podlagi podatkov kliničnih študij določena kot “redka”.
English: The reported incidence of life-threatening (grade 4) cases was < 1%.
Slovenian: Incidenca smrtno nevarnih (4. stopnje) primerov je bila < 1%.
English: To manage adverse events such as palmar-plantar erythrodysesthesia (PPE), stomatitis or haematological toxicity, the dose may be reduced or delayed.
Slovenian: Za obvladovanje neželenih učinkov, npr. palmarno-plantarne eritrodizestezije (PPE), stomatitisa ali hematološke toksičnosti, lahko odmerek zdravila zmanjšate ali odložite njegovo dajanje.
English: 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.
Slovenian: V raziskavi raka dojk so pri bolnicah z infuzijsko reakcijo dovolili naslednjo prilagoditev infundiranja: 5% celotnega odmerka so infundirali počasi v prvih 15 minutah.
English: The hypotensive response was reduced in magnitude by pretreatment with antihistamines.
Slovenian: Stopnjo hipotenzivnega učinka je zmanjšala premedikacija z antihistaminiki.
English: 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.
Slovenian: 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.
English: Grade 1 1,500 - 1,900
Slovenian: Stopnja 2 1.000 - < 1.500
English: Infusion reactions rarely recur after the first treatment cycle with Caelyx (see section 4.2).
Slovenian: Infuzijske reakcije se po prvem krogu zdravljenja z zdravilom Caelyx ponovijo le redko (glejte poglavje 4.2).
English: For common adverse events which required dose modification or discontinuation see section 4.8.
Slovenian: Za pogoste neželene učinke, ki so zahtevali prilagoditev odmerka ali ukinitev zdravila, glejte poglavje 4.8.
English: 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.
Slovenian: 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).
English: Grade 3 or 4 non-haematologic medicine related toxicity
Slovenian: V primeru pojava nehematološke toksičnosti 3. ali 4. stopnje, povezane z uporabo zdravila
English: 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.
Slovenian: 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.
English: This interim analysis showed a TTP risk reduction of 45% (95% CI: 29-57%), p < 0.0001.
Slovenian: Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45% (95% IZ; od 29 do 57%), p < 0,0001.
English: 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.
Slovenian: Te linearne skupine MPEG segajo s površine liposomov in oblikujejo zaščitno prevleko, ki zmanjšuje medsebojno delovanje med lipidno dvoplastno membrano in sestavinami plazme.
English: What you need to know before you use Caelyx
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Caelyx
English: Stinging or swelling of the skin at the site of injection may also occur.
Slovenian: Pojavi se lahko tudi občutek zbadanja ali otekanje kože na mestu injiciranja.
English: Very rarely, convulsions have been observed in relation to infusion reactions.
Slovenian: Zelo redko se lahko v povezavi z infuzijskimi reakcijami pojavijo tudi konvulzije.
English: Cases of secondary oral cancer were diagnosed both, during treatment with Caelyx, and up to 6 years after the last dose.
Slovenian: Primere sekundarnega raka v ustni votlini so ugotovili tako med zdravljenjem z zdravilom Caelyx in še do 6 let po zadnjem odmerku.
English: It is recommended that all patients receiving Caelyx routinely undergo frequent ECG monitoring.
Slovenian: Pri vseh bolnikih, ki prejemajo zdravilo Caelyx, je priporočljivo rutinsko pogosto spremljanje EKG.
English: 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.
Slovenian: 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.
English: PPE is characterised by painful, macular reddening skin eruptions.
Slovenian: Za PPE je značilen boleč, makularen pordel kožni izpuščaj.
English: The incidence of life threatening (grade 4) haematologic effects was < 1.0% and sepsis was reported in 1% of patients.
Slovenian: Incidenca smrtno nevarnih (4. stopnja) hematoloških učinkov je bila < 1,0%, o sepsi pa so poročali pri 1% bolnikov.
English: The apparent half-life ranged from 24-231 hours, with a mean of 73.9 hours.
Slovenian: Navidezni razpolovni čas je od 24 do 231 ur, srednja vrednost pa je 73,9 ur.
English: 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.
Slovenian: 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.
English: Grades 3/4** n=318
Slovenian: 3. ali 4. stopnje** n=318
English: Determine the dose of Caelyx to be administered (based upon the recommended dose and the patient's body surface area).
Slovenian: Določite odmerek zdravila Caelyx, ki ga mora bolnik prejeti (glede na priporočeni odmerek in bolnikovo telesno površino).
English: Dose modification in patients with AIDS-KS is addressed in section 4.8.
Slovenian: Prilagoditev odmerka za bolnike, ki imajo z aidsom povezan Kaposijev sarkom, je opisana v poglavju 4.8.
English: Caelyx must not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic alfa-interferon.
Slovenian: 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.
English: Store in a refrigerator (2C - 8C).
Slovenian: Shranjujte v hladilniku (2 °C-8 °C).
English: 3 and/or the platelet count is < 50,000/mm
Slovenian: 3 in/ali število trombocitov < 50.000/mm
English: This process is known as pegylation and protects liposomes from detection by the mononuclear phagocyte system (MPS), which increases blood circulation time.
Slovenian: Ta postopek, znan kot pegilacija, zavaruje liposome pred tem, da bi jih spoznal mononuklearni fagocitni sistem (MPS), kar podaljša njihovo zadrževanje v krvnem obtoku.
English: Breast cancer n=404
Slovenian: Rak dojk n=404
English: 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.
Slovenian: 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.
English: In patients with cardiac disease requiring treatment, administer Caelyx only when the benefit outweighs the risk to the patient.
Slovenian: Pri bolnikih s srčno boleznijo, ki zahteva zdravljenje, uporabite zdravilo Caelyx le, če koristi zdravljenja odtehtajo tveganje za bolnika.
English: Doxorubicin becomes available after the liposomes are extravasated and enter the tissue compartment.
Slovenian: Doksorubicin postane razpoložljiv, ko liposomi ekstravazirajo in preidejo v tkivni prostor.
English: 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.
Slovenian: 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.
English: 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
Slovenian: Ocena delovanja levega prekata je nujna pred vsakim dodatnim dajanjem zdravila Caelyx, ki presega življenjski kumulativni odmerek antraciklinov 450 mg/m
English: Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with Caelyx.
Slovenian: Ker lahko doksorubicinijev klorid škoduje dojenčku, mora ženska prenehati z dojenjem še pred začetkom zdravljenja z zdravilom Caelyx.
English: Local toxicity
Slovenian: Lokalna toksičnost