natgillin/translations-raw huggingface dataset:
A similar low incidence of myelosuppression was seen in patients with metastatic breast cancer receiving Caelyx in a first-line clinical trial.
Slično niska incidencija mijelosupresije nađena je u bolesnica s metastatskim karcinomom dojke koje su primale Caelyx kao prvu liniju u kliničkom ispitivanju.
Caelyx is a unique formulation.
Caelyx je jedinstveni oblik lijeka.
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.
Ako bolesnik osjeti rane simptome i znakove reakcije na infuziju, odmah prekinite infuziju, primijenite odgovarajuću premedikaciju (antihistaminik i/ili kratkodjelujući kortikosteroid) i nastavite infuziju smanjenom brzinom protoka.
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.
Od 418 bolesnika liječenih Caelyxom u dozi od 50 mg/m2 po ciklusu, kojima je na početku ispitivanja izmjerena ejekcijska frakcija lijeve klijetke (LVEF) i učinjeno najmanje jedno MUGA mjerenje tijekom praćenja, 88 bolesnika primilo je kumulativnu dozu antraciklina od > 400 mg/m2, što predstavlja razinu izloženosti povezanu s povećanim rizikom od kardiovaskularne toksičnosti kod konvencionalnog doksorubicina.
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.
Caelyx se može primijeniti u bolesnika s metastazama u jetri i istovremeno povišenom razinom bilirubina i jetrenih enzima do 4 puta iznad gornje granice normale.
Leukopaenia is the most frequent undesirable effect experienced with Caelyx in this population; neutropaenia, anaemia and thrombocytopaenia have been observed.
Leukopenija je najčešća nuspojava Caelyxa u ove populacije; primijećene su i neutropenija, anemija i trombocitopenija.
Acute overdosing with doxorubicin hydrochloride worsens the toxic effects of mucositis, leukopaenia and thrombocytopaenia.
Akutno predoziranje doksorubicinkloridom pogoršava toksične učinke mukozitisa, leukopenije i trombocitopenije.
Studies in rabbits have shown that the cardiotoxicity of Caelyx is reduced compared with conventional doxorubicin hydrochloride preparations.
Ispitivanja u kunića pokazala su da je Caelyx manje kardiotoksičan nego konvencionalni pripravci doksorubicinklorida.
Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30
Nositelj odobrenja za stavljanje lijeka promet Janssen-Cilag International NV Turnhoutseweg 30
Breast cancer Grades 3/4 n=254
Karcinom dojke stupanj 3/4 n=254
A phase III comparative study of Caelyx versus topotecan in patients with epithelial ovarian cancer following the failure of first-line, platinum-based chemotherapy was completed in 474 patients.
Komparativno ispitivanje faze III u kojem je Caelyx uspoređivan s topotekanom u bolesnica s epitelnim karcinomom jajnika nakon neuspješne prve linije kemoterapije na bazi platine, dovršile su 474 bolesnice.
Stomatitis/mucositis and nausea were also commonly reported in breast/ovarian cancer patient populations, whereas the AIDS-KS Program (20 mg/m2 every 2 weeks), myelosuppression (mostly leukopaenia) was the most common side effect (see AIDS-KS).
Stomatitis/mukozitis i mučnina također su često uočavani u populacije bolesnica s karcinomom dojke/jajnika, dok je u programu liječenja Kaposijevog sarkoma povezanog s AIDS-om (20 mg/m2 svaka 2 tjedna) mijelosupresija (većinom leukopenija) bila najčešća nuspojava (vidi Karposijev sarkom povezan s AIDS-om).
Caelyx 2 mg/ml concentrate for solution for infusion
Caelyx 2 mg/ml koncentrat za otopinu za infuziju
The most frequently observed OI's in clinical studies were candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumonia, and mycobacterium avium complex.
Najčešće oportunističke infekcije u kliničkim ispitivanjima bile su kandidijaza, infekcija citomegalovirusom, herpes simpleks infekcija, upala pluća prouzročena Pneumocystis carinii i infekcija Mycobacterium avium kompleksom.
A phase III randomised study of Caelyx versus doxorubicin in patients with metastatic breast cancer was completed in 509 patients.
Randomizirano ispitivanje faze III u kojem je Caelyx uspoređivan s doksorubicinom u bolesnica s metastatskim karcinomom dojke dovršilo je 509 bolesnica.
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).
Slučajevi sekundarnog karcinoma u ustima bili su prijavljeni u bolesnika koji su dugotrajno (duže od jedne godine) izloženi Caelyxu ili u onih kod koji primaju ukupnu dozu Caelyxa veću od 720 mg/m2 (vidjeti dio 4.4).
Cardiac toxicity also may occur at cumulative anthracycline doses lower than 450 mg/m2 in patients with prior mediastinal irradiation or in those receiving concurrent cyclophosphamide therapy.
Kardiotoksičnost može nastati i pri kumulativnim dozama antraciklina manjim od 450 mg/m u bolesnika koji su prethodno prošli zračenje sredoprsja ili onih koji istovremeno primaju ciklofosfamid.
Caelyx is also used to treat cancer of the ovary.
Caelyx se primjenjuje i u liječenju raka jajnika.
Do not use this medicine if you notice that it shows evidence of precipitation or any other particulate matter.
Ovaj lijek se ne smije upotrijebiti ako primijetite znakove taloženja ili druge čestice.
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).
Za razliku od iskustva u bolesnica s karcinomom dojke ili karcinomom jajnika, čini se da je mijelosupresija nuspojava koja ograničava dozu u bolesnika s Kaposijevim sarkomom povezanim s AIDS-om (vidjeti dio 4.8).
Caelyx is used to treat cancer of the breast in patients at risk for heart problems.
Caelyx se primjenjuje u liječenju raka dojke u bolesnica s rizikom za srčane tegobe.
To minimise the risk of infusion reactions, the initial dose should be administered at a rate no greater than 1 mg/minute (see section
U svrhu smanjenja rizika za reakciju na infuziju, početnu dozu treba primijeniti brzinom koja nije veća od 1 mg u minuti (vidjeti dio 4.2).
Permanent treatment discontinuation was infrequently reported at 2%.
Trajni prekid liječenja nije bio čest, zabilježene učestalosti od samo 2%.
However, in contrast to the experience with patients with AIDS-KS, when Caelyx was compared to a standard treatment for advanced ovarian cancer (topotecan), the risk of infections was substantially lower in the Caelyx-treated patients.
Međutim, za razliku od iskustva s bolesnicima koji imaju Kaposijev sarkom povezan s AIDS-om, kad je Caelyx uspoređen sa standardnim liječenjem uznapredovalog raka jajnika (topotekan), rizik od infekcija bio je znatno niži u bolesnica liječenih Caelyxom.
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.
Odmah se javite liječniku ako: - koža na šakama i stopalima postane crvena i bolna; - se pojavi bolno crvenilo kože i/ili mjehuri na tijelu ili u ustima; - se pojave srčane tegobe; - dobijete ranice u ustima; - razvijete vrućicu ili neki drugi znak infekcije; - iznenada osjetite nedostatak daha ili oštru bol u prsištu koja se može pogoršavati pri dubokom disanju ili kašljanju; - meka tkiva na nogama postanu otečena, topla ili osjetljiva na dodir, ponekad uz bolove koji se pogoršavaju pri stajanju ili hodanju.
Anxiety, depression, insomnia
Psihijatrijski poremećaji Često tjeskoba, depresija, nesanica
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.
Zbog moguće supresije koštane srži, za vrijeme trajanja liječenja Caelyxom potrebne su česte kontrole krvne slike, a obavezno prije primjene svake doze Caelyxa.
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.
Osim toga, pegilirani liposomi imaju slabo propusni lipidni matriks i unutarnji vodeni puferski sustav, koji zajedno čine omotač oko doksorubicinklorida i čuvaju ga dok se liposomi nalaze u krvotoku.
Week after prior Caelyx dose
Tjedan nakon prethodne doze Caelyxa
Endomyocardial biopsies on nine of ten AIDS-KS patients receiving cumulative doses of Caelyx greater than 460 mg/m2 indicate no evidence of anthracycline-induced cardiomyopathy.
Biopsije endomiokarda u devet od deset bolesnika s Kaposijevim sarkomom povezanim s AIDS-om koji su primili kumulativnu dozu Caelyxa veću od 460 mg/m2 nisu pokazale prisutnost antraciklinom prouzročene kardiomiopatije.
Caelyx should only be administered under the supervision of a qualified oncologist specialised in the administration of cytotoxic agents.
Caelyx se smije primjenjivati samo pod nadzorom specijaliste onkologa s iskustvom u primjeni citotoksičnih lijekova.
75,000 - 150,000 Resume treatment with no dose reduction.
1500 - 1900 75 000 - 150 000 Nastaviti liječenje bez smanjenja doze.
Grade 1 (painless ulcers, erythema, or mild soreness)
1. stupanj (bezbolni ulkusi, eritem ili blaga osjetljivost)
Caelyx contains less than 1 mmol sodium (23 mg) per dose, that is to say ‘essentially sodium-free'.
Caelyx sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
Over the dose range of 10 mg/m 2-60 mg/m 2 Caelyx displayed non-linear pharmacokinetics.
U rasponu doza od 10 mg/m 2 - 60 mg/m 2, farmakokinetika Caelyxa je nelinearna.
The plasma pharmacokinetics of Caelyx in humans differ significantly from those reported in the literature for standard doxorubicin hydrochloride preparations.
Farmakokinetika Caelyxa u plazmi u ljudi značajno se razlikuje od farmakokinetike standardnih pripravaka doksorubicinklorida zabilježene u literaturi.
On any day of medicine administration after day 1 of each cycle:
Bilo koji dan primjene lijeka nakon 1. dana svakog ciklusa: Broj trombocita < 25 000/mm
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.
Mučnina i povraćanje bili su češći u skupini koja je primala kombiniranu terapiju (40% i 28%) nego u skupini koja je primala monoterapiju (32% i 15%) i bili su uglavnom 1. i 2. stupnja težine.
During repeat dose toxicology studies in dogs, an acute response characterised by hypotension, pale mucous membranes, salivation, emesis and periods of hyperactivity followed by hypoactivity and lethargy was observed following administration of pegylated liposomes (placebo).
Za vrijeme ispitivanja toksičnosti ponovljene doze u pasa, nakon primjene pegiliranih liposoma (placebo) primijećen je akutni odgovor obilježen hipotenzijom, bljedoćom sluznica, salivacijom, povraćanjem i razdobljima hiperaktivnosti nakon kojih su slijedile hipoaktivnost i letargija.
See Table 5 for complete listing of undesirable effects reported in Caelyx-treated patients.
Vidjeti tablicu 5 za potpuni popis nuspojava zabilježenih u bolesnika liječenih Caelyxom.
Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells.
Caelyx sadrži djelatnu tvar koja djeluje na stanice tako da ubija isključivo stanice raka.
Caelyx is available in glass vials as a single pack or packs of ten vials.
Caelyx je dostupan u staklenim bočicama u pakiranjima od jedne ili deset bočica.
- Partially used vials must be discarded.
- Djelomično iskorištene bočice moraju se odbaciti.
None of the 10 Caelyx subjects who had cardiac toxicity by LVEF criteria developed signs and symptoms of CHF.
Niti jedan od 10 ispitanika liječenih Caelyxom koji su pokazivali znakove kardiotoksičnosti prema LVEF kriterijima, nije razvio znakove i simptome kroničnog zatajenja srca.
Standard doxorubicin hydrochloride displays extensive tissue distribution (volume of distribution: 700 to 1,100 l/m 2) and a rapid elimination clearance (24 to
Standardni doksorubicinklorid opsežno se raspodjeljuje u tkiva (volumen raspodjele: 700 do 1100 l/m 2) i brzo eliminira klirensom (24 do 73 l/h/m 2).
The protocol-specified objective of demonstrating non-inferiority between Caelyx and doxorubicin was met, the hazard ratio (HR) for progression-free survival (PFS) was 1.00 (95% CI for HR=0.82-1.22).
Cilj određen planom ispitivanja bio je pokazati neinferiornost Caelyxa u odnosu na doksorubicin te je i postignut, a omjer rizika (HR) za preživljenje bez napredovanja bolesti iznosio je 1,00 (95% CI za HR=0,82 - 1,22).
There was a benefit in overall survival (OS) for Caelyx-treated patients over topotecan-treated patients as indicated by a hazard ratio (HR) of 1.216 (95% CI: 1.000; 1.478), p=0.050.
Postojala je korist za opće preživljenje (OS) u bolesnica liječenih Caelyxom u odnosu na bolesnice liječene topotekanom, kako je pokazao omjer rizika (HR) od 1,216 (95% CI: 1,000; 1,478), p=0,050.
For the sub-group of patients with platinum-sensitive disease the difference was greater: HR of 1.432 (95% CI: 1.066; 1.923), p=0.017.
U podskupini bolesnica koje su reagirale na platinu, razlika je bila veća: HR od 1,432 (95% CI: 1,066; 1,923), p=0,017.
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).
Program liječenja Kaposijevog sarkoma povezanog s AIDS-om Klinička ispitivanja u bolesnika s Kaposijevim sarkomom povezanim s AIDS-om liječenih dozom od 20 mg/m2 Caelyxa pokazuju da je mijelosupresija bila najčešća nuspojava koja se smatra povezanom s Caelyxom i koja se javljala vrlo često (u približno jedne polovice bolesnika).
Hypersensitivity to the active substance, peanut or soya, or to any of the excipients listed in section
Preosjetljivost na djelatnu tvar, kikiriki ili soju ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Adverse drug reactions identified during the post-marketing experience with Caelyx Neoplasms benign, malignant and unspecified (incl cysts and polyps) very rare secondary oral neoplasms
Tablica 9. Nuspojave identificirane nakon stavljanja lijeka Caelyx u promet Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) vrlo rijetko sekundarna neoplazma u ustima
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.
Stomatitis je bio češći u skupini s kombiniranim liječenjem (16%) nego u skupini koja je primala monoterapiju (3%), a težina stomatitisa je u većini slučajeva bila 2. stupnja ili manja.
Grade 2 (painful erythema, oedema, or ulcers, but can eat)
2. stupanj (bolni eritem, edemi ili ulkusi, ali bolesnik može jesti)
Stomatitis has been reported in patients receiving continuous infusions of conventional doxorubicin hydrochloride and was frequently reported in patients receiving Caelyx.
Stomatitis je bio uočen u bolesnika koji su primali kontinuiranu infuziju konvencionalnog doksorubicinklorida i bio je čest u bolesnika koji su primali Caelyx.
Of 646 patients with multiple myeloma who have received at least 1 prior therapy, 318 patients were treated with combination therapy of Caelyx 30 mg/m2 as a one hour intravenous infusion administered on day 4 following bortezomib which is administered at 1.3 mg/m² on days 1, 4, 8, and 11, every three weeks or with bortezomib monotherapy in a phase III clinical trial.
U kliničkom ispitivanju faze III, od 646 bolesnika s multiplim mijelomom koji su prethodno primili najmanje jednu liniju terapije, 318 bolesnika liječeno je kombiniranom terapijom Caelyxa u dozi od 30 mg/m2 u obliku jednosatne intravenske infuzije primijenjene 4. dan nakon bortezomiba koji se primjenjivao u dozi od 1,3 mg/m² 1., 4., 8. i 11. dana svaka tri tjedna, ili monoterapijom bortezomiba.
Platelet count < 25,000/mm Haemoglobin < 8 g/dl ANC < 500/mm
Hemoglobin < 8 g/dl ANC < 500/mm
For doses < 90 mg, dilute Caelyx in 250 ml, and for doses  90 mg, dilute Caelyx in 500 ml.
Za doze < 90 mg, razrijedite Caelyx u 250 ml, a za doze  90 mg, razrijedite Caelyx u 500 ml.
Caelyx 2 mg/ml concentrate for solution for infusion Pegylated liposomal doxorubicin hydrochloride
Caelyx 2 mg/ml koncentrat za otopinu za infuziju pegilirani liposomalni doksorubicinklorid
Skin and subcutaneous tissue disorders Very common
Poremećaji kože i potkožnog tkiva Vrlo često
Treatment related undesirable effects reported in multiple myeloma clinical trial (Caelyx 30 mg/m2 in combination with bortezomib every 3 weeks) by severity, MedDRA system organ class and preferred term Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100)
Nuspojave povezane s liječenjem multiplog mijeloma u kliničkim ispitivanjima (Caelyx 30 mg/m2 u kombinaciji s bortezomibom svaka 3 tjedna)po stupnju težine, MedDRA klasifikaciji organskih sustava i MedDRA izrazu Vrlo često (≥ 1/10); Često (≥ 1/100, < 1/10); Manje često (≥ 1/1000, < 1/100)
Opportunistic infections are observed in KS patients after administration with Caelyx, and are frequently observed in patients with HIV-induced immunodeficiency.
Oportunističke infekcije znaju se javiti u bolesnika s Kaposijevim sarkomom nakon primjene Caelyxa, a često se opaze u bolesnika s imunodeficijencijom prouzročenom HIV-om.
Pruritus, papular rash, allergic dermatitis, erythema, skin hyperpigmentation, petechiae, alopecia, medicine eruption
pruritus, papularni osip, alergijski dermatitis, eritem, hiperpigmentacija kože, petehije, alopecija, erupcija izazvana lijekom
Caelyx exhibits unique pharmacokinetic properties and must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Caelyx ima jedinstvena farmakokinetička svojstva i ne smije se zamjenjivati s drugim oblicima doksorubicinklorida.
Neutropaenia, thrombocytopaenia, and anaemia were the most frequently reported haematologic events reported with both combination therapy of Caelyx plus bortezomib and bortezomib monotherapy.
Neutropenija, trombocitopenija i anemija bile su najčešće hematološke nuspojave kako uz kombinirano liječenje Caelyxom i bortezomibom, tako i uz monoterapiju bortezomibom.
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
Postupci procjene i praćenja srčanih funkcija koji su specifičniji od EKG-a su ehokardiografsko mjerenje ejekcijske frakcije lijeve klijetke ili, po mogućnosti, višekanalna angiografija (MUGA).
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).
Ako se liječite zbog raka dojke ili raka jajnika, Caelyx ćete primati u dozi od 50 mg po kvadratnom metru površine tijela (na temelju
For more detailed information on bortezomib dosing and dosage adjustments, see the SPC for bortezomib.
Za detaljnije informacije o doziranju i prilagodbi doze bortezomiba, vidjeti sažetak opisa svojstava lijeka za bortezomib.
Moreover, in a controlled clinical trial of Caelyx vs. topotecan, the incidence of treatment related sepsis was substantially less in the Caelyx-treated ovarian cancer patients as compared to the topotecan treatment group.
Štoviše, u kontroliranom kliničkom ispitivanju Caelyxa u usporedbi s topotekanom, incidencija sepse povezane s liječenjem bila je znatno manja u bolesnica s karcinomom jajnika liječenih Caelyxom nego u skupini liječenoj topotekanom.
PPE was reported in 16% of multiple myeloma patients treated with Caelyx plus bortezomib combination therapy.
PPE je bio uočen u 16% bolesnika s multiplim mijelomom liječenih kombinacijom lijekova Caelyx i bortezomib.
During the infusion of Caelyx, the following reactions may occur: flushing of the face, shortness of breath, headache, chills, back pain, tightness in the chest and/or throat, sore throat, low or increase in blood pressure, rapid heart beat, puffing of the face, fever, dizziness, nausea, indigestion, itching, rash and sweating.
Za vrijeme infuzije Caelyxa mogu nastati sljedeće reakcije: crvenilo lica, nedostatak daha, glavobolja, zimice, križobolja, stezanje u prsištu i/ili grlu, grlobolja, nizak ili povišen krvni tlak, ubrzan rad srca, otok lica, vrućica, omaglica, mučnina, probavne tegobe, svrbež, osip i znojenje.
-(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)--methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE) fully hydrogenated soy phosphatidylcholine (HSPC) cholesterol ammonium sulphate sucrose histidine water for injections hydrochloric acid (for pH-adjustment) sodium hydroxide (for pH-adjustment)
-(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) natrijev hidroksid (za prilagodbu pH)
* for more information on bortezomib dosing and dosage adjustment, see the SPC for bortezomib
* Za dodatne informacije o doziranju i prilagodbama doze bortezomiba, vidjeti sažetak opisa svojstava lijeka za bortezomib.
Uncommon side effects (may affect up to 1 in 100 people) - confusion; - inflammation of the veins and formation of blood clots in the veins which could lead to blockage of blood flow to your lungs causing difficulty breathing, chest pain and palpitations; - abnormal heart rhythm, heart beat feels fast or uneven (palpitations), heart failure, which makes you short of breath and may lead to swollen legs, cardiac arrest.
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - smetenost; - upala vena i nastanak krvnih ugrušaka koji mogu dovesti do zaustavljanja protoka krvi u pluća i uzrokovati poteškoće s disanjem, bol u prsištu i lupanje srca; - nenormalan srčani ritam, osjećaj ubrzanog ili nepravilnog lupanja srca (palpitacije), zatajenje srca, koje uzrokuje nedostatak zraka i može dovesti do oticanja nogu, srčani zastoj.
Grade 3 (painful erythema, edema, or ulcers, but cannot eat)
3. stupanj (bolni eritem, edemi ili ulkusi, bolesnik ne može jesti)
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.
Tijekom liječenja Caelyxom, u 100 od 929 bolesnika (10,8%) sa solidnim tumorima prijavljene su reakcije povezane s infuzijom definirane u skladu sa sljedećim Costart izrazima: alergijska reakcija, anafilaktoidna reakcija, astma, edem lica, hipotenzija, vazodilatacija, urtikarija, križobolja, bol u prsištu, zimice, vrućica, hipertenzija, tahikardija, dispepsija, mučnina, vrtoglavica, dispneja, faringitis,
Do not dose this cycle if before day 4; if after day 4, reduce next dose by 25%.
Nemojte primijeniti dozu u ovom ciklusu ako su navedene nuspojave uočene prije 4. dana ciklusa; ako se jave nakon 4. dana, smanjite sljedeću dozu za 25%.