natgillin/translations-raw huggingface dataset:
The active substance in ONIVYDE pegylated liposomal is irinotecan (topoisomerase I inhibitor) encapsulated in a lipid bilayer vesicle or liposome.
Djelatna tvar lijeka ONIVYDE pegilirani liposomalni je irinotekan (inhibitor topoizomeraze I) inkapsuliran u vezikul s lipidnim dvoslojem, odnosno liposom.
ONIVYDE pegylated liposomal is for intravenous use.
ONIVYDE pegilirani liposomalni je namijenjen za intravensku primjenu.
You can also report side effects directly via the national reporting system listed in
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
Following recovery to Grade 1 diarrhoea, resume ONIVYDE pegylated liposomal at a reduced dose (see section 4.2).
Nakon oporavka na proljev stupnja 1, treba nastaviti primjenu lijeka ONIVYDE pegilirani liposomalni u smanjenoj dozi (vidjeti dio 4.2).
Renal impairment and acute renal failure have been identified, usually in patients who become volume depleted from nausea/vomiting and/or diarrhoea.
Oštećenje bubrega i akutno zatajenje bubrega identificirani su uglavnom u bolesnika s deplecijom volumena zbog mučnine/povraćanja i/ili proljeva.
ONIVYDE pegylated liposomal must only be given by healthcare professionals trained in giving anticancer medicines
Kako se ONIVYDE pegilirani liposomalni primjenjuje ONIVYDE pegilirani liposomalni smije dati samo zdravstveni radnik obučen za davanje lijekova protiv raka
A new cycle of therapy should not begin until the adverse reaction resolves to ≤ Grade 1
Novi ciklus liječenja ne smije se započinjati sve dok se nuspojava ne povuče na ≤ stupanj 1
Nausea/vomiting
Mučnina/povraćanje
ONIVYDE pegylated liposomal (irinotecan) is not equivalent to non-liposomal irinotecan formulations and should not be interchanged.
ONIVYDE pegilirani liposomalni (irinotekan) nije ekvivalentan neliposomalnim formulacijama irinotekana te se ne smiju međusobno zamjenjivati.
ONIVYDE is supplied as a sterile liposomal dispersion at a concentration of 4.3 mg/ml and must be diluted prior to administration.
ONIVYDE pegilirani liposomalni se isporučuje kao sterilna liposomalna disperzija u koncentraciji od 4,3 mg/ml i mora se razrijediti prije primjene.
Table 2: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities in patients homozygous for UGT1A1*28
Tablica 2: Preporučene modifikacije doze za ONIVYDE pegilirani liposomalni +5-FU/LV za toksičnosti stupnja 3-4 u bolesnika koji su homozigoti za UGT1A1*28
ONIVYDE pegylated liposomal is not equivalent to other non-liposomal irinotecan formulations and should not be interchanged.
ONIVYDE pegilirani liposomalni nije ekvivalentan drugim neliposomalnim formulacijama irinotekana te se ne smiju međusobno zamjenjivati.
METHOD AND ROUTE OF ADMINISTRATION For single use only.
Samo za jednokratnu uporabu.
Consideration should be given to substituting with non-enzyme inducing therapies at least 2 weeks prior to initiation of ONIVYDE pegylated liposomal therapy (see section 4.5).
Potrebno je razmotriti zamjenu terapijama koje ne induciraju enzim najmanje 2 tjedna prije započinjanja terapije lijekom ONIVYDE
• ONIVYDE pegylated liposomal is a cytotoxic medicinal product and caution should be exercised in handling it.
• ONIVYDE pegilirani liposomalni je citotoksični lijek s kojim je potrebno oprezno rukovati.
ONIVYDE pegylated liposomal should not be administered with strong CYP3A4-enzyme inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John's wort unless there are no therapeutic alternatives.
CYP3A4 kao što su antikonvulzivi (fenitoin, fenobarbital ili karbamazepin), rifampicin, rifabutin i gospina trava osim ako ne postoje terapijske alternative.
Hazard Ratio (95% CI) p-value
Omjer hazarda (95% CI)3 p-vrijednost4
Rate Difference (95% CI) p-value
Razlika stopa (95% CI)5
ONIVYDE pegylated liposomal is supplied as a white to slightly yellow opaque isotonic liposomal dispersion in a glass vial.
Kako ONIVYDE pegilirani liposomalni izgleda i sadržaj pakiranja ONIVYDE pegilirani liposomalni se isporučuje kao bijela do blago žuta neprozirna izotonična liposomalna disperzija u staklenoj bočici.
Therefore, co-administration of ONIVYDE pegylated liposomal with other inhibitors of CYP3A4 (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) may increase systemic exposure of ONIVYDE pegylated liposomal.
Stoga, istodobna primjena lijeka ONIVYDE pegilirani liposomalni s drugim inhibitorima CYP3A4 (npr. sok od grejpa, klaritromicin, indinavir, itrakonazol, lopinavir, nefazodon, nelfinavir, ritonavir, sakvinavir, telaprevir,
Pregnant staff should not handle ONIVYDE pegylated liposomal.
Trudno osoblje ne smije rukovati lijekom ONIVYDE pegilirani liposomalni.
Renal impairment and acute renal failure have been identified, usually in patients who became volume depleted from severe vomiting and/or diarrhoea.
Oštećenje bubrega i akutno zatajenje bubrega identificirani su uglavnom u bolesnika s deplecijom volumena zbog teškog povraćanja i/ili proljeva.
Diarrhoea is a very common adverse reaction leading to colitis, ileus, gastroenteritis, fatigue, dehydration, weight loss, renal toxicities, hyponatraemia, and hypokalaemia.
Proljev je vrlo česta nuspojava koja dovodi do kolitisa, ileusa, gastroenteritisa, umora, dehidracije,
Water for injections See leaflet for further information.
Za dodatne informacije vidjeti uputu o lijeku.
Grade 3 or higher anaemia occurred in 10.3% of patients treated with ONIVYDE pegylated liposomal +5-FU/LV and in 6.7% of patients treated with 5-FU/LV.
Anemija stupnja 3 ili višeg javila se u 10,3% bolesnika koji su primali ONIVYDE pegilirani liposomalni +5-FU/LV i u 6,7% bolesnika koji su primali samo 5-FU/LV.
Type I glass vial with a grey chlorobutyl stopper and an aluminium seal with a flip-off cap, containing 10 ml of concentrate.
I sa sivim klorobutilnim čepom i aluminijskim prstenom s flip-off poklopcem,
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Patients who are known to be homozygous for UGT1A1*28 and without drug related toxicities during the first cycle of therapy (reduced dose of 50 mg/m2) may have the dose of ONIVYDE pegylated liposomal increased to a total dose of 70 mg/m in subsequent cycles based on individual patient tolerance.
Bolesnicima za koje je poznato da su homozigoti za UGT1A1*28 i nemaju toksičnosti povezane s lijekom tijekom prvog ciklusa liječenja (smanjena doza od 50 mg/m2) doza lijeka ONIVYDE
A new cycle of therapy should not begin until the platelet count is ≥ 100,000 platelets/mm
Novi ciklus liječenja ne smije se započinjati sve dok broj trombocita nije ≥100 000 trombocita/mm3
Sepsis with neutropenic fever and consequent septic shock with fatal outcome has been observed in patients with metastatic pancreatic adenocarcinoma treated with ONIVYDE pegylated liposomal.
U bolesnika s metastatskim adenokarcinomom gušterače koji su liječeni lijekom ONIVYDE pegilirani liposomalni zabilježena je sepsa s neutropenijskom vrućicom te posljedičnim septičkim šokom sa smrtnim ishodom.
How to handle and dispose of ONIVYDE pegylated liposomal
Kako rukovati i zbrinuti ONIVYDE pegilirani liposomalni
Strong CYP3A4 inducers
Snažni induktori CYP3A4
Table 1: Recommended dose modifications for ONIVYDE pegylated liposomal +5-FU/LV for Grade 3-4 toxicities for patients not homozygous for UGT1A1*28
Tablica 1: Preporučene modifikacije doze za ONIVYDE pegilirani liposomalni +5-FU/LV za toksičnosti stupnja 3-4 u bolesnika koji nisu homozigoti za UGT1A1*28
In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, 5 of 8 underweight patients experienced a Grade 3 or 4 adverse reactions, mostly myelosuppression, while 7 of the 8 patients required dose modification such as dose delay, dose reduction or dose discontinuation.
+5-FU/LV, 5 od 8 pothranjenih bolesnika imalo je nuspojave stupnja 3 ili 4, uglavnom mijelosupresiju, dok je za 7 od 8 bolesnika bila potrebna modifikacija doze kao što je odgađanje doze, smanjenje doze ili prekid doziranja.
The population pharmacokinetic analysis suggest that Asians have 56% lower total irinotecan average steady state concentration (3.93 [95%CI: 3.68-4.2] and 1.74 [95%CI: 1.58-1.93] mg/l, respectively) and 8% higher total SN-38 average steady state concentration (0.97 [95%CI: 0.92-1.03] and 1.05 [95%CI: 0.98-1.11] ng/ml, respectively) than Caucasians.
odnosno 1,74 [95%CI: 1,58-1,93] mg/l) i 8% višu prosječnu koncentraciju ukupnog SN-38 u stanju dinamičke ravnoteže (0,97 [95%CI: 0,92-1,03] odnosno 1,05 [95%CI: 0,98-1,11] ng/ml) od bijelaca.
Patients with severe bone marrow failure should not be treated with ONIVYDE pegylated liposomal.
Bolesnici s teškim zatajenjem koštane srži ne smiju se liječiti lijekom
The population pharmacokinetic analysis in patients aged 28 to 87 years, of whom 11% were ≥75 years suggests that age had no clinically meaningful effect on the exposure to irinotecan and SN-38.
Populacijska farmakokinetička analiza u bolesnika u dobi od 28 do 87 godina, od kojih je 11% bilo
What ONIVYDE pegylated liposomal contains
Što ONIVYDE pegilirani liposomalni sadrži
Grade 3 or higher thrombocytopenia occurred in 2.6% of patients treated with ONIVYDE pegylated liposomal +5-FU/LV and 0% in patients treated with 5-FU/LV.
Trombocitopenija stupnja 3 ili višeg javila se u 2,6% bolesnika koji su primali ONIVYDE pegilirani liposomalni +5-FU/LV i u 0% bolesnika koji su primali samo 5-FU/LV.
The volume of distribution of ONIVYDE pegylated liposomal 70 mg/m was 2.6 l/m 2, which suggests that
Volumen distribucije lijeka ONIVYDE pegilirani liposomalni 70 mg/m2 bio je 2,6 l/m2, što upućuje na to da je ONIVYDE pegilirani liposomalni u velikoj mjeri ograničen na vaskularnu tekućinu.
No carcinogenicity studies have been performed with ONIVYDE pegylated liposomal.
Nisu provedena ispitivanja kancerogenosti s lijekom ONIVYDE pegilirani liposomalni.
Regular monitoring of complete blood counts should be conducted in patients with total bilirubin of 1.0-2.0 mg/dl.
U bolesnika s ukupnim bilirubinom od 1,0-2,0 mg/dl potrebno je provesti redovito praćenje kompletne krvne slike.
A new cycle of therapy should not begin until nausea/vomiting resolves to ≤ Grade 1 or baseline
Novi ciklus liječenja ne smije se započinjati sve dok se mučnina/povraćanje ne povuče na ≤ stupanj 1 ili na prvobitno stanje
Complete blood cell count monitoring is recommended during ONIVYDE pegylated liposomal treatment.
Tijekom liječenja lijekom ONIVYDE pegilirani liposomalni preporučuje se praćenje kompletne krvne slike.
ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
ONIVYDE pegilirani liposomalni 4,3 mg/ml koncentrat za otopinu za infuziju Irinotekan
Gastrointestinal disorders Very common: Diarrhoea, Vomiting, Nausea, Abdominal pain, Stomatitis
Vrlo često: proljev, povraćanje, mučnina, bol u abdomenu, stomatitis
Based on the drug interaction of non-liposomal irinotecan and ketoconazole, co-administration of ONIVYDE pegylated liposomal with other inhibitors of UGT1A1 (e.g. atazanavir, gemfibrozil, indinavir) may also increase systemic exposure of ONIVYDE pegylated liposomal.
pegilirani liposomalni s drugim inhibitorima UGT1A1 (npr. atazanavir, gemfibrozil, indinavir) može također povećati sustavnu izloženost lijeku ONIVYDE pegilirani liposomalni.
Diarrhoea and related adverse reactions
Proljev i povezane nuspojave
No dedicated pharmacokinetic study has been conducted in patients with hepatic impairment.
Nije provedeno posebno farmakokinetičko ispitivanje u bolesnika s oštećenjem jetre.
Servier Pharma, d. o. o. Tel: + 385 (0)1 3016 222
Tel: + 385 (0)1 3016 222
Optimise antiemetic therapy Reduce ONIVYDE pegylated liposomal dose to 50 mg/m
Optimizirati antiemetsku terapiju Smanjiti dozu lijeka ONIVYDE pegilirani liposomalni na 50 mg/m2
One ml of concentrate contains 4.3 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Jedan ml koncentrata sadrži 4,3 mg bezvodne slobodne baze irinotekana (u obliku irinotekansaharozasulfata u pegiliranoj liposomskoj formulaciji).
Suomi/Finland Servier Finland Oy P. /Tel: +358 (0)9 279 80 80
P. /Tel: +358 (0)9 279 80 80
A reduced starting dose of ONIVYDE pegylated liposomal (irinotecan) of 50 mg/m should be considered for patients known to be homozygous for the UGT1A1*28 allele (see sections 4.8 and 5.1).
Za bolesnike za koje je poznato da su homozigoti za alel UGT1A1*28 potrebno je razmotriti smanjenu početnu dozu lijeka ONIVYDE pegilirani liposomalni (irinotekan) od 50 mg/m2 (vidjeti dijelove 4.8 i 5.1).
How to store ONIVYDE pegylated liposomal
Kako čuvati ONIVYDE pegilirani liposomalni
70 mg/m
≥ 3,0 g/dl.
ONIVYDE pegylated liposomal is a cytotoxic medicinal product, and caution should be exercised in handling it.
ONIVYDE pegilirani liposomalni je citotoksični lijek s kojim je potrebno oprezno rukovati.
What ONIVYDE pegylated liposomal is used for
Za što se ONIVYDE pegilirani liposomalni koristi
(anaemia) - Low level of blood platelets (thrombocytopenia) - Diarrhoea (loose or watery and frequent stools) - Nausea and vomiting - Pain in the stomach or in the gut area - Sore mouth - Loss of weight - Loss of appetite - Loss of body fluid (dehydration) - Low level of salts (electrolytes) in the body (e.g. of potassium, magnesium) - Unusual hair loss - Tiredness - Dizziness - Swelling and fluid retention in the soft tissues (peripheral oedema)
- Niske razine bijelih krvnih stanica (neutropenija i leukopenija), niske razine crvenih krvnih stanica (anemija) - Niska razina trombocita (trombocitopenija) - Proljev (mekane ili vodenaste i česte stolice)
Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie
A PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
Store in a refrigerator (2°C-8°C).
6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2°C-8°C).
Servier Laboratories (Ireland) Ltd. Tel: + 353 (0)1 663 8110
Tel: + 353 (0)1 663 8110
Acute renal failure
- Opća slabost
AUC= area under the plasma concentration curve (extrapolated to infinity for ONIVYDE pegylated liposomal and AUC24h for non-liposomal irinotecan) Cmax= maximum plasma concentration t1/2 effective= effective half-lives
AUC= površina ispod krivulje koncentracije u plazmi (ekstrapolirano do beskonačnosti za ONIVYDE
No dedicated pharmacokinetic study has been conducted in patients with renal impairment.
Nije provedeno posebno farmakokinetičko ispitivanje u bolesnika s oštećenjem bubrega.
Tabulated list of adverse reactions
Opis odabranih nuspojava
Optimise antiemetic therapy Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Optimizirati antiemetsku terapiju Smanjiti dozu lijeka ONIVYDE pegilirani liposomalni na 43 mg/m2
Water for injections
Infekcije i infestacije
Česká republika Servier s.r.o.
Servier Slovensko spol. s r.o.
OTHER SPECIAL WARNING(S), IF NECESSARY Onivyde pegylated liposomal (irinotecan) is not equivalent to non-liposomal formulations.
Onivyde pegilirani liposomalni (irinotekan) nije ekvivalentan neliposomalnim formulacijama.
A dose increase of ONIVYDE pegylated liposomal to 70 mg/m should be considered if tolerated in subsequent cycles.
pegilirani liposomalni može se povećati do ukupne doze od 70 mg/m2 u narednim ciklusima temeljeno na podnošljivosti pojedinog bolesnika.
A reticulo-nodular pattern on chest X-ray was observed in a small percentage of patients enrolled in a clinical study with irinotecan.
Kod malog postotka bolesnika uključenih u kliničko ispitivanje s irinotekanom na rendgenu prsnog koša uočen je retikulonodularni oblik.
tightness in the chest or throat during or shortly after your infusion - if you experience fever, chills or other symptoms of infection - if you get diarrhoea with frequent liquid stools and cannot control this after 12 to 24 hours of treatment (see below) - if you get breathlessness or cough.
- ako osjetite vrućicu, zimicu ili druge simptome infekcije - ako dobijete proljev s čestim tekućim stolicama i ne možete to kontrolirati nakon 12 do 24 sata liječenja (vidjeti u nastavku) - ako osjetite nedostatak zraka ili kašljete - ako primijetite znakove ili simptome krvnog ugruška, poput iznenadne boli i oticanja noge ili ruke, iznenadnog napada kašlja, iznenadne boli u prsnom košu ili otežanog disanja.
Overall, no major clinical differences in safety or efficacy were reported between patients ≥ 65 years and patients < 65 years, although a higher frequency of discontinuation (14.8% vs 7.9%) was noted in the former group treated with ONIVYDE pegylated liposomal +5-FU/LV in the NAPOLI-1 study and in some cases the adverse reactions did not resolve.
Sveukupno, nisu prijavljene velike kliničke razlike u sigurnosti i djelotvornosti lijeka između bolesnika ≥ 65 godina i bolesnika < 65 godina, iako je veća učestalost prekida liječenja (14,8%
The safety and efficacy of ONIVYDE pegylated liposomal in children and adolescents aged ≤ 18 years have not yet been established.
Pedijatrijska populacija Sigurnost i djelotvornost lijeka ONIVYDE pegilirani liposomalni u djece i adolescenata u dobi
No genotoxicity studies have been performed with ONIVYDE pegylated liposomal.
Nisu provedena ispitivanja genotoksičnosti s lijekom ONIVYDE pegilirani liposomalni.
Neutropenic fever/sepsis appeared more frequently in the ONIVYDE pegylated liposomal +5-FU/LV combination arm [in 4 patients (3.4%)] compared to 5-FU/LV control arm [in 1 patient (0.7%)].
Neutropenijska vrućica/sepsa javila se učestalije u skupini bolesnika koji su primali kombinaciju ONIVYDE pegilirani liposomalni +5-FU/LV [u 4 bolesnika (3,4%)] u usporedbi s kontrolnom skupinom koja je primala samo 5-FU/LV
A total of 417 patients were randomised to the ONIVYDE pegylated liposomal +5-FU/LV arm (N=117), ONIVYDE pegylated liposomal monotherapy arm (N=151) and 5-FU/LV arm (N=149).
Ukupno 417 bolesnika randomizirano je za skupinu koja je primala ONIVYDE pegilirani liposomalni +5-FU/LV (N=117), za skupinu koja je primala ONIVYDE pegilirani liposomalni u monoterapiji
Cholesterol
DSPC kolesterol
Nervous system disorders Very common: Dizziness Common: Cholinergic syndrome, Dysgeusia
Često: kolinergički sindrom, disgeuzija
How ONIVYDE pegylated liposomal is used
Kako se ONIVYDE pegilirani liposomalni primjenjuje
Reduce ONIVYDE pegylated liposomal dose to 50 mg/m
Smanjiti dozu lijeka ONIVYDE pegilirani liposomalni na 50 mg/m2
Reduce ONIVYDE pegylated liposomal dose to 43 mg/m
Smanjiti dozu ONIVYDE pegilirani liposomalni na 43 mg/m2
Servier Pharma d. o. o. Tel: + 386 (0)1 563 48 11
Tel: + 386 (0)1 563 48 11
headache, tightness in the chest or throat - Abnormal fluid retention in the body causing swelling in the affected tissues (oedema)
- Upala želuca i crijeva (gastroenteritis) - Sustavna upala tijela uzrokovana infekcijom (sepsa)
Thrombocytopenia
topoizomeraze I.
(maculo-papular rash) - Change in the colour of the nail plates
Manje često: makulopapularni osip, promjene boje noktiju
Adverse reaction frequency** Infections and infestations Common: Septic shock, Sepsis, Pneumonia, Febrile neutropenia, Gastroenteritis, Oral candidiasis Uncommon: Biliary sepsis
Često: septički šok, sepsa, upala pluća, febrilna neutropenija,
Servier Deutschland GmbH Tel: +49 (0)89 57095 01
Tel: +49 (0)89 57095 01
Lot:
Serija:
STATEMENT OF ACTIVE SUBSTANCE One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
NAVOĐENJE DJELATNE TVARI Jedna bočica sa 10 ml koncentrata sadrži 43 mg bezvodne slobodne baze irinotekana (u obliku irinotekansaharozasulfata u pegiliranoj liposomskoj formulaciji).
Acute infusion reactions were reported in 8 of 117 patients (6.8%) in the ONIVYDE pegylated liposomal +5-FU/LV arm, 3 of 147 patients (2.0%) in the ONIVYDE pegylated liposomal monotherapy arm, and 8 of 134 patients (6.0%) in the 5-FU/LV arm.
ONIVYDE pegilirani liposomalni +5-FU/LV, u 3 od 147 bolesnika (2,0%) u skupini koja je primala ONIVYDE pegilirani liposomalni kao monoterapiju i u 8 od 134 bolesnika (6,0%) u skupini koja je primala samo 5-FU/LV.
In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, the frequency of ≥ Grade 3 neutropenia in these patients [2 of 7 (28.6%)] was similar to the frequency in patients not homozygous for the UGT1A1*28 allele who received a starting dose of ONIVYDE pegylated liposomal of 70 mg/m
U kliničkom ispitivanju koje je procjenjivalo ONIVYDE pegilirani liposomalni +5-FU/LV, učestalost neutropenije stupnja ≥3 u tih bolesnika [2 od 7 (28,6%)]
ONIVYDE pegylated liposomal should not be administered as a single agent.
ONIVYDE pegilirani liposomalni se ne smije primjenjivati kao monoterapija.
Vascular disorders
Trombocitopenija
Reduce ONIVYDE pegylated liposomal dose to 35 mg/m
Smanjiti dozu lijeka ONIVYDE pegilirani liposomalni na 35 mg/m2
Patients randomised to ONIVYDE pegylated liposomal +5-FU/LV received ONIVYDE pegylated liposomal at 70 mg/m as an intravenous infusion over 90 minutes, followed by
Bolesnici randomizirani za ONIVYDE pegilirani liposomalni +5-FU/LV primali su 70 mg/m2 lijeka ONIVYDE pegilirani liposomalni putem intravenske infuzije tijekom 90 minuta, nakon čega je slijedio LV 400 mg/m2 intravenski tijekom 30 minuta te potom 5-FU 2400 mg/m2 intravenski tijekom 46 sati, primijenjeno svaka 2 tjedna.
Close monitoring of blood counts is recommended, and the use of myeloid growth factors should be considered for patients with a history of abdominal radiation.
Kod bolesnika s anamnezom zračenja abdomena preporučuje se pomno praćenje krvne slike, a potrebno je razmotriti i primjenu mijeloidnih faktora rasta.
Uncommon (may affect up to 1 in 100 people) - Systemic body inflammation, caused by infection of the gall bladder and bile ducts (biliary sepsis) - Allergic reaction to ONIVYDE pegylated liposomal (the active substance or the excipients) - Diminished availability of oxygen to the body tissues - Inflammation of the oesophagus (food pipe) - Formation or presence of a blood clot within a blood vessel - vein or artery (thrombosis) - Inflammation of the lining of the rectum (the end of the large intestine) - Type of rash, characterised by appearance of a flat, red area on the skin covered with bumps
- Smanjena raspoloživost kisika u tjelesnim tkivima - Upala jednjaka (cijevi kroz koju prolazi hrana do želuca) - Stvaranje ili prisutnost krvnog ugruška u krvnoj žili - veni ili arteriji (tromboza)
The use of gloves, goggles and protective clothing when handling or administering ONIVYDE pegylated liposomal is recommended.
pegilirani liposomalni preporučuje se uporaba rukavica, naočala i zaštitne odjeće.
ONIVYDE pegylated liposomal is a cancer medicine that contains the active substance irinotecan.
Što je ONIVYDE pegilirani liposomalni i za što se koristi Što je ONIVYDE pegilirani liposomalni i kako djeluje ONIVYDE pegilirani liposomalni je lijek protiv raka koji sadrži djelatnu tvar irinotekan.
- If you get any side effects, talk to your doctor or nurse.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
Excipients
Proljev
Non haematological toxicities
Nehematološke toksičnosti2
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion Irinotecan
Uputa o lijeku: Informacije za korisnika ONIVYDE pegilirani liposomalni 4,3 mg/ml koncentrat za otopinu za infuziju
One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
Jedna bočica sa 10 ml koncentrata sadrži 43 mg bezvodne slobodne baze irinotekana (u obliku irinotekansaharozasulfata u pegiliranoj liposomskoj formulaciji).
Servier Laboratories c/o Icepharma hf Sími: + 354 540 8000
Servier Laboratories c/o Icepharma hf
NAME OF THE MEDICINAL PRODUCT ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for solution for infusion
ONIVYDE pegilirani liposomalni 4,3 mg/ml koncentrat za otopinu za infuziju
Common: Colitis, Haemorrhoids
- Umor - Omaglica
Сервие Медикал ЕООД Тел.
Stoga, istodobna primjena lijeka ONIVYDE