FrancophonIA/ELRC3.0 huggingface dataset:
English: If tolerated, the infusion may then be completed over the next hour for a total infusion time of 90 minutes.
Croatian: U slučaju dobrog podnošenja infuzije istu je moguće dovršiti tijekom sljedećih sat vremena, uz ukupno trajanje cijele infuzije od 90 minuta.
English: Acute overdosing worsens side effects like sores in the mouth or decreases the number of white blood cells and platelets in the blood.
Croatian: Ako primijenite više Caelyxa nego što ste trebali Akutno predoziranje pogoršava nuspojave poput ranica u ustima ili smanjenja broja bijelih krvnih stanica i krvnih pločica.
English: GRADE
Croatian: STUPANJ
English: 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%).
Croatian: bortezomib) bile su mučnina (40%), proljev (35%), neutropenija (33%), trombocitopenija (29%), povraćanje (28%), umor (27%) i zatvor (22%).
English: Caelyx in patients has not suggested a significant nephrotoxicity liability of Caelyx, these findings in monkeys may not have relevance to patient risk assessment.
Croatian: Budući da analiza baze podataka o sigurnosti primjene nakon stavljanja lijeka u promet ne ukazuje na značajnu nefrotoksičnost Caelyxa, navedeni nalazi dobiveni u majmuna možda nisu važni za procjenu rizika u bolesnika.
English: Toxicity grade at current assessment
Croatian: Procjena postojećeg stupnja toksičnosti
English: If this change occurs, the most definitive test for anthracycline myocardial injury, i.e., endomyocardial biopsy, must be considered.
Croatian: Nastupi li ova promjena, potrebno je razmotriti primjenu biopsije endomiokarda, pretrage koja će definitivno potvrditi radi li se o antraciklinskom oštećenju miokarda.
English: Caelyx, a liposome formulation, is doxorubicin hydrochloride encapsulated in liposomes with surface-bound methoxypolyethylene glycol (MPEG).
Croatian: Caelyx je liposomalna formulacija pri čemu je doksorubicinklorid inkapsuliran u liposomima na čiju je površinu vezan metoksipolietilen glikol (MPEG).
English: Reproductive system and breast disorders Common
Croatian: Poremećaji reproduktivnog sustava i dojki
English: The haematological toxicity for ovarian cancer patients is less severe than in the AIDS-KS setting (see section for ovarian cancer patients above).
Croatian: Hematološka toksičnost teža je kod bolesnika s Kaposijevim sarkomom povezanim s AIDS-om nego kod bolesnica s karcinomom jajnika (vidjeti gore dio za bolesnice s karcinomom jajnika).
English: 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%.
Croatian: U bolesnika s Kaposijevim sarkomom povezanim s AIDS-om, reakcije povezane s infuzijom bile su obilježene napadima crvenila, nedostatkom daha, edemom lica, glavoboljom, zimicama, bolom u leđima, stezanjem u prsištu i grlu i/ili hipotenzijom, s očekivanom učestalošću od 5% do 10%.
English: The pharmacokinetics of Caelyx was evaluated in 120 patients from 10 different clinical trials using the population pharmacokinetic approach.
Croatian: Farmakokinetika Caelyxa procijenjena je populacijskim farmakokinetskim pristupom u 120 bolesnika u 10 različitih kliničkih ispitivanja.
English: Ovarian cancer Grades 3/4 n=512
Croatian: Karcinom jajnika stupanj 3/4 n=512
English: 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.
Croatian: Preporučuje se infuzijsku cijev za Caelyx spojiti preko postraničnog otvora infuzijske cijevi za intravensku primjenu 5%-tne (50 mg/ml) glukoze, kako bi se postiglo dodatno razrjeđenje i smanjio rizik za trombozu i ekstravazaciju.
English: Metabolism and nutrition disorders common anorexia
Croatian: Poremećaji metabolizma i prehrane često anoreksija
English: Caelyx is supplied as a single pack or packs of ten vials.
Croatian: Caelyx je dostupan u pakiranjima s jednom ili deset bočica.
English: 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).
Croatian: Ako se liječite zbog Kaposijevog sarkoma, Caelyx ćete primati u dozi od 20 mg po kvadratnom metru površine tijela (na temelju
English: Anaemia, leukopaenia Febrile neutropaenia, lymphopaenia
Croatian: Često leukopenija anemija, leukopenija febrilna neutropenija, limfopenija
English: EU/1/96/011/001 (1 vial) EU/1/96/011/002 (10 vials)
Croatian: EU/1/96/011/001 (1 bočica) EU/1/96/011/002 (10 bočica)
English: In this pooled analysis of 4,231 patients receiving Caelyx, ventricular arrythmia, palpitations, cardiac failure, cardiac arrest, bundle branch block right, and ejection fraction decreased were reported uncommonly, and atrioventricular block, cyanosis, and conduction disorder were reported rarely.
Croatian: U ovoj analizi objedinjenih podataka 4231 bolesnika koji su primali Caelyx, manje često su prijavljivane ventrikularna aritmija, palpitacije, zatajenje srca, srčani zastoj, blok desne grane snopa i smanjena ejekcijska frakcija, a rijetko su prijavljivani atrioventrikularni blok, cijanoza i poremećaj provođenja.
English: 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.
Croatian: Farmakokinetika Caelyxa utvrđena u 11 bolesnica s karcinomom jajnika bila je slična farmakokinetici utvrđenoj u većoj populaciji od 120 bolesnika s raznim karcinomima.
English: See the SPC for bortezomib.
Croatian: Vidjeti sažetak opisa svojstava lijeka za bortezomib.
English: See Table 7 for adverse effects reported in ≥ 5% patients treated with combination therapy of Caelyx plus bortezomib.
Croatian: Vidjeti tablicu 7 za nuspojave uočene u ≥ 5% bolesnika liječenih kombiniranom terapijom lijekovima Caelyx i bortezomib.
English: The incidence of grade 3 and 4 neutropaenia was higher in the combination therapy group than in the monotherapy group (28% vs. 14%).
Croatian: Incidencija neutropenije 3. i 4. stupnja bila je veća u skupini liječenoj kombiniranom terapijom nego u skupini koja je primala monoterapiju (28% naspram 14%).
English: EU/1/96/011/003 (1 vial) EU/1/96/011/004 (10 vials)
Croatian: EU/1/96/011/003 (1 bočica) EU/1/96/011/004 (10 bočica)
English: Cardiovascular disorder
Croatian: Srčani poremećaji
English: Guidelines for Caelyx dose modification secondary to these adverse effects are provided in the tables below.
Croatian: Smjernice za prilagodbu doze Caelyxa, zbog ovih nuspojava prikazane su u tablicama koje slijede.
English: Partially used vials must be discarded.
Croatian: Djelomično iskorištene bočice moraju se odbaciti.
English: The incidence of grade 3 and 4 thrombocytopaenia was higher in the combination therapy group than in the monotherapy group (22% vs. 14%).
Croatian: Incidencija trombocitopenije 3. i 4. stupnja bila je veća u skupini liječenoj kombinacijom lijekova nego u skupini koja je primala monoterapiju (22% naspram 14%).
English: Caelyx is an antitumour agent.
Croatian: Caelyx je antitumorski lijek.
English: 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
Croatian: U pivotalnom ispitivanju faze III usporedbe s doksorubicinom, 58/509 (11,4%) randomiziranih ispitanika (10 liječenih Caelyxom u dozi od 50 mg/m2/svaka 4 tjedna nasuprot 48 liječenih doksorubicinom u dozi od 60 mg/m2/svaka 3 tjedna) ispunilo je za vrijeme liječenja ili praćenja kriterije za kardiotoksičnost definirane planom ispitivanja.
English: Please note that each vial of Caelyx contains sucrose and the dose is administered in 5% (50 mg/ml) glucose solution for infusion.
Croatian: Imajte na umu da svaka bočica Caelyxa sadrži saharozu i da se doza primjenjuje u 5%-tnoj (50 mg/ml) otopini glukoze za infuziju.
English: The median TTP was 6.9 months for the bortezomib monotherapy patients compared with 8.9 months for the Caelyx plus bortezomib combination therapy patients.
Croatian: Medijan za TTP iznosio je 6,9 mjeseci u bolesnika liječenih monoterapijom bortezomibom u usporedbi s 8,9 mjeseci u bolesnika liječenih kombinacijom Caelyxa i bortezomiba.
English: In controlled clinical studies in patients with AIDS-KS against a bleomycin/vincristine regimen, opportunistic infections were apparently more frequent during treatment with Caelyx.
Croatian: U kontroliranim kliničkim ispitivanjima kod bolesnika s Kaposijevim sarkomom povezanim s AIDSom u usporedbi s protokolom bleomicin/vinkristin, oportunističke infekcije bile su prividno češće za vrijeme liječenja Caelyxom.
English: Partially used vials should be discarded.
Croatian: Djelomično iskorištene bočice potrebno je odbaciti.
English: * Palmar-plantar erythrodysesthesia (Hand-foot syndrome).
Croatian: * palmarno-plantarna eritrodizestezija (sindrom šake i stopala).
English: In a pooled analysis of 4,231 patients receiving Caelyx for breast cancer, ovarian cancer, multiple myeloma, or AIDS-related KS, ventricular arrythmia, palpitations, cardiac failure, cardiac arrest, bundle branch block right, and ejection fraction decreased were reported uncommonly, and atrioventricular block, cyanosis, and conduction disorder were reported rarely.
Croatian: U analizi objedinjenih podataka 4231 bolesnika koji su primali Caelyx za karcinom dojke, karcinom jajnika, multipli mijelom ili KS povezanog s AIDS-om, manje često su prijavljivane ventrikularna aritmija, palpitacije, zatajenje srca, srčani zastoj, blok desne grane snopa i smanjena ejekcijska frakcija, a rijetko su prijavljivani atrioventrikularni blok, cijanoza i poremećaj provođenja.
English: 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.
Croatian: Postotci preživljenja bolesnica koje su primale Caelyx iznosili su 74,1% na kraju 1. godine, 51,2% na kraju 2. godine i 28,4% na kraju 3. godine u usporedbi s 66,2%, 31,0% i 17,5% u bolesnica liječenih topotekanom.
English: Vascular disorders uncommon venous thromboembolism, including thrombophlebitis, venous thrombosis and pulmonary embolism
Croatian: Krvožilni poremećaji manje često venska tromboembolija, uključujući tromboflebitis, vensku trombozu i plućnu emboliju
English: If tolerated without reaction, the infusion rate may then be doubled for the next 15 minutes.
Croatian: Ukoliko nema reakcije na infuziju, brzina infuzije može se tijekom sljedećih 15 minuta udvostručiti.
English: As with other DNA-damaging antineoplastic agents, secondary acute myeloid leukemias and myelodysplasias have been reported in patients having received combined treatment with doxorubicin.
Croatian: Kao i s drugim antineoplastičkim lijekovima koji oštećuju DNK, u bolesnika koji su primili kombinirano liječenje doksorubicinom zabilježene su sekundarne akutne mijeloidne leukemije i mijelodisplazije.
English: 509 patients with advanced breast cancer who had not received prior chemotherapy for metastatic disease were treated with Caelyx (n=254) at a dose of 50 mg/m2 every 4 weeks, or doxorubicin
Croatian: U kliničkom ispitivanju faze III (I97-328), 509 bolesnica s uznapredovalim karcinomom dojke koje prethodno nisu primale kemoterapiju zbog metastatske bolesti bile su liječene Caelyxom (n=254) u dozi od 50 mg/m2 svaka 4 tjedna ili doksorubicinom (n=255) u dozi od 60 mg/m2 svaka 3 tjedna.
English: AIDS-related KS Caelyx is administered intravenously at 20 mg/m2 every two-to-three weeks.
Croatian: Kaposijev sarkom povezan s AIDS-om Caelyx se primjenjuje intravenski u dozi od 20 mg/m2 svaka dva do tri tjedna.
English: DO NOT USE INTERCHANGEABLY WITH OTHER FORMULATIONS OF DOXORUBICIN HYDROCHLORIDE.
Croatian: NEMOJTE PRIMJENJIVATI NAIZMJENCE S DRUGIM FORMULACIJAMA DOKSORUBICINKLORIDA.
English: 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.
Croatian: Pomoćne tvari: -(2-[1,2-distearoil-sn-glicero(3)fosfooksi]etilkarbamoil)- -metoksipoli(oksietilen)40 natrijeva sol, potpuno hidrogenirani fosfatidilkolin iz soje, kolesterol, amonijev sulfat, saharoza, histidin, voda za injekcije, kloridna kiselina i natrijev hidroksid.
English: The dose of Caelyx is diluted in 250 ml 5% (50 mg/ml) glucose solution for infusion and administered by intravenous infusion over 30 minutes.
Croatian: Doza Caelyxa razrjeđuje se u 250 ml 5%-tne (50 mg/ml) otopine glukoze za infuziju i primjenjuje intravenskom infuzijom tijekom 30 minuta.
English: 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.
Croatian: Medijan za TTP iznosio je 6,5 mjeseci kod bolesnika liječenih monoterapijom bortezomibom u usporedbi s 9,3 mjeseca kod bolesnika liječenih kombinacijom Caelyxa i bortezomiba.
English: Cardiac disorders Common
Croatian: Često kardiovaskularni poremećaj
English: 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.
Croatian: Iz kliničkog ispitivanja u kojem se uspoređivao Caelyx s drugim liječenjem (bleomicin/vinkristin) u bolesnika s Kaposijevim sarkomom povezanim s AIDS-om, poznato je da može postojati povećana mogućnost nekih infekcija uz Caelyx.
English: Caelyx must be handled and disposed of in a manner consistent with that of other anticancer medicinal products in accordance with local requirements.
Croatian: Način rukovanja lijekom Caelyx i njegovo uklanjanje moraju biti sukladni načinu rukovanja i uklanjanja drugih antitumorskih lijekova sukladno nacionalnim propisima.
English: Dehydration, cachexia
Croatian: Često dehidracija, kaheksija
English: It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ml) glucose.
Croatian: Preporučuje se spajanje linije za infuziju Caelyxa preko postraničnog ulaza na cijevi za intravensku infuziju 5%-tne (50 mg/ml) glukoze.
English: Anorexia
Croatian: Često anoreksija
English: The recommended dose of Caelyx for AIDS-KS patients is 20 mg/m2 every two-to-three weeks.
Croatian: Preporučena doza Caelyxa za bolesnike s Kaposijevim sarkomom povezanim s AIDS-om iznosi 20 mg/m2 svaka dva do tri tjedna.
English: Neuropathy peripheral, neuropathy, paraesthesia, polyneuropathy, dizziness, dysgeusia
Croatian: Često periferna neuropatija, neuropatija, parestezija, polineuropatija, omaglica, dizgeuzija neuralgija, periferna neuropatija, neuropatija letargija, hipoestezija, sinkopa, disestezija
English: Dehydration, hypokalaemia, hyperkalaemia, hypomagnesaemia, hyponatraemia, hypocalcaemia
Croatian: Često smanjen apetit anoreksija dehidracija, hipokalijemija, hiperkalijemija, hipomagnezijemija, hiponatrijemija, hipokalcemija
English: Peripheral sensory neuropathy, neuralgia, headache
Croatian: Poremećaji živčanog sustava Vrlo često periferna senzorna neuropatija, neuralgija, glavobolja
English: Concentrate for solution for infusion
Croatian: Koncentrat za otopinu za infuziju.
English: Haematological toxicity (ANC or platelets) - Management of patients with breast or ovarian cancer
Croatian: Tablica 3. Hematološka toksičnost (apsolutni broj neutrofila [ANC] ili broj trombocita)Liječenje bolesnica s karcinomom dojke ili jajnika
English: 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.
Croatian: Bolesnici s Kaposijevim sarkomom povezanim s AIDS-om Farmakokinetika Caelyxa u plazmi utvrđena je u 23 bolesnika s Kaposijevim sarkomom koji su primili jednokratnu dozu od 20 mg/m2 primijenjenu infuzijom u trajanju od 30 minuta.
English: Pegylated liposomes contain surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol (MPEG).
Croatian: Na površini pegiliranih liposoma nalaze se umetnuti segmenti hidrofilnog polimera metoksipolietilen glikola (MPEG).
English: 45.2-98.5 hours).
Croatian: Prosječni poluvijek bio je 71,5 sati (raspon 45,2 - 98,5 sati).
English: In patients with solid tumours, including a subset of patients with breast and ovarian cancers, treated at a dose of 50 mg/m2/cycle with lifetime cumulative anthracycline doses up to 1,532 mg/m2, the incidence of clinically significant cardiac dysfunction was low.
Croatian: U bolesnika sa solidnim tumorima, uključujući podskupinu bolesnica s karcinomom dojke ili jajnika, liječenih dozom od 50 mg/m2 po ciklusu uz doživotnu kumulativnu dozu antraciklina do
English: Dosage adjustments for Caelyx + bortezomib combination therapy - patients with multiple myeloma
Croatian: Tablica 4. Prilagodbe doze kod kombiniranog liječenja lijekovima Caelyx i bortezomib bolesnici s multiplim mijelomom
English: One ml of Caelyx contains 2 mg pegylated liposomal doxorubicin hydrochloride.
Croatian: Jedan ml lijeka Caelyx sadrži 2 mg pegiliranog liposomalnog doksorubicinklorida.
English: How Caelyx is given
Croatian: Kako se Caelyx daje
English: 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.
Croatian: Postotci preživljenja bolesnica koje su primale Caelyx iznosili su 41,5% na kraju 1. godine, 21,1% na kraju 2. godine i 13,8% na kraju 3. godine u usporedbi s preživljenjem od 43,2%, 17,2% i 9,5% u bolesnica liječenih topotekanom.
English: Headache, peripheral sensory neuropathy, paraesthesia, dizziness
Croatian: Manje često glavobolja, periferna senzorna neuropatija, parestezija, omaglica
English: Infection, oral moniliasis, herpes zoster, urinary tract infection
Croatian: Infekcije i infestacije Često faringitis infekcija, oralna monilijaza, herpes zoster, infekcija mokraćnih puteva
English: Dry skin, skin discolouration
Croatian: Poremećaji kože i potkožnog tkiva
English: For doses < 90 mg: dilute Caelyx in 250 ml 5% (50 mg/ml) glucose solution for infusion.
Croatian: Za doze < 90 mg: Caelyx razrijediti u 250 ml 5%-tne (50 mg/ml) otopine glukoze za infuziju.
English: - The other ingredients are -(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) and sodium hydroxide (for pH-adjustment).
Croatian: - Pomoćne tvari: -(2-[1,2-distearoil-sn-glicero(3)fosfooksi]etilkarbamoil)-metoksipoli(oksietilen)-40 natrijeva sol (MPEG-DSPE), potpuno hidrogenirani fosfatidilkolin iz soje (HSPC), kolesterol, amonijev sulfat, saharoza, histidin, voda za injekcije, kloridna kiselina (za prilagodbu pH) i natrijev hidroksid (za prilagodbu pH).
English: 1 vial
Croatian: 1. stupanj
English: For doses  90 mg: dilute Caelyx in 500 ml 5% (50 mg/ml) glucose solution for infusion.
Croatian: Za doze  90 mg: Caelyx razrijediti u 500 ml 5%-tne (50 mg/ml) otopine glukoze za infuziju.
English: Peripheral oedema, chills, influenza-like illness, malaise, hyperthermia
Croatian: Često astenija, umor periferni edemi, zimice, bolest slična gripi, malaksalost, hipertermija
English: Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.
Croatian: Caelyx se ne može primjenjivati naizmjence s drugim oblicima doksorubicinklorida.
English: How to use Caelyx
Croatian: Kako primjenjivati Caelyx
English: Grade 3 500 - < 1,000 25,000 - < 50,000 Wait until ANC  1,500 and platelets
Croatian: 500 - < 1000 25 000 - < 50 000 Pričekati dok ANC bude  1500 i trombociti  75 000; nastaviti primjenu bez smanjenja doze.
English: CAELYX CARTON 50 mg/25 ml - 1 vial CAELYX CARTON 50 mg/25 ml - 10 vials
Croatian: CAELYX KUTIJA 50 mg/25 ml - 1 bočica CAELYX KUTIJA 50 mg/25 ml - 10 bočica
English: Grade 2 1,000 - < 1,500 50,000 - < 75,000 Wait until ANC  1,500 and platelets
Croatian: 1000 - < 1500 50 000 - < 75 000 Pričekati dok ANC bude  1500 i trombociti  75 000; nastaviti primjenu bez smanjenja doze.
English: The appropriate dose of Caelyx must be diluted in 5% (50 mg/ml) glucose solution for infusion prior to administration.
Croatian: Odgovarajuća doza Caelyxa mora se razrijediti u 5%-tnoj (50 mg/ml) otopini glukoze za infuziju prije primjene.
English: 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.
Croatian: Kumulativna doza pri kojoj bi kardiotoksičnost bila razlog za zabrinutost u ovih bolesnika s Kaposijevim sarkomom povezanim s AIDS-om (> 400 mg/m2) bila bi doza primljena u više od
English: One ml of Caelyx contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.
Croatian: Jedan ml lijeka Caelyx sadrži 2 mg doksorubicinklorida u obliku pegiliranih liposoma.
English: 5 How to store Caelyx Contents of the pack and other information
Croatian: Kako Caelyx izgleda i sadržaj pakiranja
English: Metabolism and nutrition disorders Very common
Croatian: Poremećaji metabolizma i prehrane Vrlo često anoreksija
English: Ovarian cancer program
Croatian: Program liječenja karcinoma jajnika
English: Investigations common weight loss
Croatian: Pretrage često smanjenje tjelesne težine
English: Pharmacokinetic parameters in Caelyx-treated AIDS-KS patients Mean + standard error
Croatian: Farmakokinetički parametri u bolesnika s Kaposijevim sarkomom povezanim s AIDS-om liječenih Caelyxom
English: Caelyx pharmacokinetics determined in a small number of patients with elevated total bilirubin levels do not differ from patients with normal total bilirubin; however, until further experience is gained, the Caelyx dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian clinical trial programs as follows: at initiation of therapy, if the bilirubin is between 1.2-3.0 mg/dl, the first dose is reduced by 25%.
Croatian: Međutim, bez dodatnog iskustva, a na temelju uočenog u programu kliničkih ispitivanja liječenja karcinoma dojke i jajnika, u bolesnika s oštećenjem funkcije jetre potrebno je smanjiti dozu Caelyxa na sljedeći način: kod uvođenja lijeka, ako je bilirubin između 1,2 - 3,0 mg/dl prva se doza smanjuje za 25%.
English: 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.
Croatian: U bolesnika s multiplim mijelomom koji se liječe Caelyxom u kombinaciji s bortezomibom i koji razviju PPE ili stomatitis, dozu Caelyxa potrebno je prilagoditi kako je opisano u gornjoj tablici 1, odnosno 2. Tablica 4 pokazuje druge prilagodbe doze primjenjene u kliničkom ispitivanju liječenja bolesnika s multiplim mijelomom koji su primali kombinaciju lijekova Caelyx i bortezomib.
English: CAELYX CARTON 20 mg/10 ml - 1 vial CAELYX CARTON 20 mg/10 ml - 10 vials
Croatian: CAELYX KUTIJA 20 mg/10 ml - 1 bočica CAELYX KUTIJA 20 mg/10 ml - 10 bočica
English: Intravenous use, following dilution in 5% (50 mg/ml) glucose solution for infusion.
Croatian: Za intravensku primjenu, nakon razrjeđenja u 5%-tnoj (50 mg/ml) otopini glukoze za infuziju.
English: 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.
Croatian: Postotak preživljenja bolesnica koje su primale Caelyx na kraju 1. godine ispitivanja iznosio je 56,3%, na kraju 2. godine 34,7%, a na kraju 3. godine 20,2% u usporedbi s postotkom preživljenja od 54,0%, 23,6% odnosno 13,2% u bolesnica liječenih topotekanom.