natgillin/translations-raw huggingface dataset:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 2016
Datum prve odobritve: 14. oktober 2016
Clearance (CL)
Očistek (CL)
The appropriate starting dose for patients taking these anticonvulsants or other strong inducers has not been defined.
Ustrezen začetni odmerek za bolnike, ki jemljejo te antikonvulzive ali druge močne induktorje, ni bil določen.
The primary outcome measure was Overall Survival (OS).
Primarno merilo izida je bilo celokupno preživetje (OS, overall survival).
Patients who require further dose reduction should discontinue treatment.
Bolniki, ki potrebujejo nadaljnje zmanjšanje odmerka, morajo zdravljenje prekiniti.
Each pack contains one vial.
Eno pakiranje vsebuje eno vialo.
Your doctor may give you a medicine which contains loperamide to begin treatment at home but it must not be used for longer than 48 consecutive hours.
Zdravnik vam bo morda dal zdravilo, ki vsebuje loperamid, s katerim se boste začeli zdraviti doma, vendar ga ne smete uporabljati dlje kot 48 ur zaporedoma.
Immunosuppressive effects and vaccines
Imunosupresivni učinki in cepiva
Contact your doctor immediately to give you a suitable treatment.
Takoj se obrnite na zdravnika, ki bo uvedel primerno zdravljenje.
For more details see section 6.6.
Za več podrobnosti glejte poglavje 6.6.
Your doctor may need to adjust the dose or stop treatment.
Vaš zdravnik bo morda moral spremeniti odmerek ali zdravljenje prekiniti.
Grade 3 or 4
3. ali 4. stopnje
stomatitis and pyrexia.
stomatitis in pireksija.
Per RECIST guidelines, v 1.1.
Skladno s smernicami RECIST, v 1.1.
Grade 3 or 4 (despite antiemetic therapy)
3. ali 4. stopnje (kljub antiemetičnemu zdravljenju)
It is important that you are aware of what these side effects may be.
Pomembno je, da veste, kateri so možni neželeni učinki.
• The active substance is irinotecan.
• Učinkovina je irinotekan.
Results are shown in Table 4.
Rezultati so prikazani v preglednici 4.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik.
You will need to have further (blood or other) tests during treatment so that your doctor can monitor your blood cells and assess how you are responding to the treatment.
Med zdravljenjem boste morali iti še na dodatne (krvne ali drugačne) preiskave, tako da bo zdravnik lahko spremljal krvne celice in ocenil, kako se odzivate na zdravljenje.
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1130/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1130/001
Overall survival is illustrated in Figure 1.
Celokupno preživetje je prikazano na sliki 1.
Total SN-38
Skupni SN-38
In certain cases, lower doses or longer dosing intervals may be required.
V določenih primerih so potrebni manjši odmerki ali daljši intervali med odmerjanjem.
The severity of effects was dose-related and reversible.
Resnost učinkov je bila povezana z odmerkom in je bila reverzibilna.
The following side effects may occur:
Pojavijo se lahko naslednji neželeni učinki:
Tell your doctor if you are or think you may be pregnant.
Obvestite zdravnika, če ste noseči ali menite, da bi lahko bili noseči.
Median is the Kaplan-Meier estimate of the median survival time
Mediana je ocena srednjega časa preživetja po Kaplan-Meierju
Patients should be informed about the signs and symptoms of thromboembolism and advised to contact their physician or nurse immediately if any such signs or symptoms should occur.
Bolnike je treba obvestiti o znakih in simptomih trombembolije in jim svetovati, da se v primeru katerega od teh znakov ali simptomov takoj obrnejo na svojega zdravnika ali medicinsko sestro.
The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
Koncentrat ima pH 7,2 in osmolalnost 295 mOsm/kg.
Figure 1: Overall survival
Slika 1 Celokupno preživetje
* MedDRA version 14.1 ** Rare occurrence cannot be estimated from the NAPOLI-1study due to the small sample size
* Različica MedDRA 14.1 ** Redkih pojavnosti iz študije NAPOLI-1 zaradi majhne velikosti vzorca ni mogoče oceniti
The adverse reactions in these patients were similar to those reported with the recommended dosage and regimen.
Neželeni učinki pri teh bolnikih so bili podobni kot tisti, o katerih so poročali pri priporočenih odmerkih in režimu odmerjanja.
• From a microbiological point of view, the product should be used as soon as possible after dilution.
• Z mikrobiološkega vidika je treba zdravilo uporabiti čim prej po razredčitvi.
ONIVYDE pegylated liposomal must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ONIVYDE pegilirani liposomski ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
Patient demographic and entry disease characteristics were well balanced between trial arms.
Demografski podatki bolnikov in značilnosti bolezni ob vključitvi so bili uravnoteženi med vejami preskušanja.
Neutropenia/leukopenia was the most notable important haematological toxicity.
Nevtropenija/levkopenija je bila najopaznejša pomembna hematološka toksičnost.
Your doctor may also prescribe other medicines to help control your side effects.
Zdravnik vam lahko predpiše tudi druga zdravila, ki vam bodo pomagala obvladati neželene učinke.
Hypersensitivity reactions, including acute infusion reaction may occur.
Lahko se pojavijo preobčutljivostne reakcije, vključno z akutno infuzijsko reakcijo.
Each pack contains one vial with 10 ml of concentrate.
Eno pakiranje vsebuje eno vialo z 10 ml koncentrata.
You can also report side effects directly via the national reporting system listed in
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v
During treatment patients should observe caution when driving or using machines.
Bolniki morajo biti med zdravljenjem pri vožnji in upravljanju strojev previdni.
Therefore, based on results from animal studies and the mechanism of action of irinotecan, ONIVYDE pegylated liposomal should not be used during pregnancy unless clearly necessary.
Zato na podlagi rezultatov študij na živalih in mehanizma delovanja irinotekana zdravila ONIVYDE pegilirani liposomski ne smemo uporabljati med nosečnostjo, razen če je nujno potrebno.
Additional outcome measures included Progression Free Survival (PFS) and Objective Response Rate (ORR).
Dodatna merila izida so vključevala preživetje brez napredovanja (PFS, progression-free survival) in objektivni odziv na zdravljenje (ORR, objective response rate).
Due to its mechanism of action, irinotecan is considered a potential carcinogen.
Irinotekan zaradi svojega mehanizma delovanja velja za potencialni kancerogen.
A thorough medical history should be obtained in order to identify patients with multiple risk factors in addition to the underlying neoplasm.
Treba je pridobiti podrobno zdravstveno anamnezo, da bi prepoznali bolnike z več dejavniki tveganja poleg osnovne neoplazme.
The most significant adverse reactions reported were severe neutropenia and severe diarrrhoea.
Najpomembnejša neželena učinka, o katerih so poročali, sta bila huda nevtropenija in huda driska.
Irinotecan is a derivative of camptothecin.
Irinotekan je derivat kamptotecina.
Adverse reaction frequency**
Pogostnost neželenih učinkov**
The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby allowing it to act for longer.
Liposomi naj bi se nakopičili v tumorju in sčasoma počasi sproščali zdravilo ter tako omogočili, da učinkuje dlje časa.
Total irinotecan
Skupni irinotekan
Prior Whipple procedure
Predhodna Whipplova operacija
If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Če raztopina pride v stik s kožo, kožo takoj in temeljito izperite z milom in vodo.
Carefully follow all instructions given to you by your doctor or nurse.
Natančno upoštevajte vsa navodila, ki ste jih prejeli od zdravnika ali medicinske sestre.
Within each system organ class and frequency category, adverse reactions are presented in order of decreasing seriousness.
Znotraj vsake kategorije organskega sistema in pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Precautions to be taken before handling or administering the medicinal product
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila
Marketing Authorisation Holder Les Laboratoires Servier 50, rue Carnot
Imetnik dovoljenja za promet z zdravilom Les Laboratoires Servier 50, rue Carnot
Patients should be aware of the risk of neutropenia and the significance of fever.
Bolniki se morajo zavedati tveganja za nevtropenijo in pomena povišane telesne temperature.
In patients experiencing early diarrhoea, therapeutic and prophylactic atropine should be considered unless contraindicated.
Pri bolnikih, ki doživijo zgodnji pojav driske, je treba razmisliti o terapevtskem in profilaktičnem zdravljenju z atropinom, razen če je kontraindicirano.
Abbreviations: 5-FU/LV=5-fluorouracil/leucovorin; CI=confidence interval
Okrajšave: 5-FU/LV = 5-fluorouracil/levkovorin; IZ = interval zaupanja
Febrile neutropenia (body temperature > 38°C and neutrophil count ≤ 1,000 cells/mm³) should be urgently treated in the hospital with broad-spectrum intravenous antibiotics.
Febrilno nevtropenijo (telesna temperatura > 38 °C in število nevtrofilcev ≤ 1.000 celic/mm³) je treba nujno zdraviti v bolnišnici s širokospektralnimi intravenskimi antibiotiki.
The LV dose does not require adjustment.
Odmerka LV ni treba prilagajati.
Loperamide should be given until patient is without diarrhoea for at least 12 hours.
Loperamid je treba dajati, dokler bolnik ni brez driske vsaj 12
If diarrhoea persists for more than 48 hours, stop loperamide, monitor and replace fluid electrolytes and continue antibiotic support until resolution for accompanying symptoms.
Če driska traja več kot 48 ur, zdravljenje z loperamidom prekinite, nadzirajte in nadomeščajte tekočinske elektrolite in nadaljujte z antibiotično podporo, dokler spremljevalni simptomi ne izginejo.
Grade 2
2. stopnje
Acute infusion and related reactions
Akutne infuzijske in povezane reakcije
Non-liposomal irinotecan displays a large volume of distribution (138 l/m2).
Neliposomski irinotekan ima velik porazdelitveni volumen (138 l/m2).
Do not throw away this medicine via wastewater or household waste.
Tega zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
It blocks an enzyme called topoisomerase I, which is involved in the division of cell DNA.
Zavira encim, imenovan topoizomeraza I, ki je vključen v delitev celične DNA.
The safety and efficacy of ONIVYDE pegylated liposomal in children and adolescents aged ≤ 18 years have not yet been established.
Varnost in učinkovitost zdravila ONIVYDE pegilirani liposomski pri otrocih in mladostnikih, starih ≤ 18 let, še nista bili dokazani.
There have been reports of overdosage with non-liposomal irinotecan at doses up to approximately twice the recommended therapeutic dose of irinotecan, which may be fatal.
Poročali so o primerih prevelikega odmerjanja z neliposomskim irinotekanom v odmerkih do približno dvakrat večjih od priporočenega terapevtskega odmerka za irinotekan, ki so lahko usodni.
Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France
Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex Francija
Disease characteristics included 68% of patients with liver metastases and 31% with lung metastases; 12% of patients had no prior lines of metastatic therapy, 56 % of patients had 1 prior line of metastatic therapy, 32% of patients had 2 or more prior lines of metastatic therapy.
Značilnosti bolezni so zajemale 68 % bolnikov z jetrnimi metastazami in 31 % s pljučnimi metastazami; 12 % bolnikov se predhodno ni zdravilo zaradi metastaz, 56 % bolnikov se je predhodno zdravilo z eno linijo zdravljenja za metastaze, 32 % bolnikov se je predhodno zdravilo z dvema ali več linijami zdravljenja za metastaze.
Patients should have loperamide (or equivalent) readily available to begin treatment for late diarrhoea.
Bolniki morajo imeti takoj na voljo loperamid (ali enakovredno zdravilo) za zdravljenje pozne driske.
Grade 3 or Grade 4 (< 1,000 cells/mm3) or
3. ali 4. stopnja (< 1.000 celic/mm3) ali nevtropenična vročina
Neutropenic fever/neutropenic sepsis was reported in 6% of Asian patients compared to 1% of Caucasians patients.
O nevtropenični vročini/nevtropenični sepsi so poročali pri 6 % bolnikov azijskega porekla v primerjavi z 1 % kavkazijskih bolnikov.
Loperamide should be initiated at first occurrence of poorly formed or loose stools or at the earliest onset of bowel movements more frequent than normal.
Loperamid je treba uvesti ob prvem pojavu neoblikovanega ali mehkega blata ali takoj, ko odvajanje blata postane pogostejše kot običajno.
Loperamide should not be used for more than 48 consecutive hours due to risk of paralytic ileus.
Loperamida zaradi tveganja za paralitični ileus ne smemo uporabljati več kot 48 ur zaporedoma.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat za raztopino za infundiranje.
Third occurrence Discontinue treatment
Tretji pojav Prekinite zdravljenje
If diarrhoea persists while patient is on loperamide for more than 24 hours, adding oral antibiotic support (e.g. fluoroquinolone for 7 days) should be considered.
Če driska traja tudi, ko bolnik prejema loperamid več kot 24 ur, je treba razmisliti o dodatni peroralni antibiotični podpori (npr. fluorokinolonu, ki ga bolnik jemlje 7 dni).
There was insufficient data in patients with severe renal impairment (CLcr < 30 ml/min) to assess its effect on pharmacokinetics (see sections 4.2 and 4.4).
Pri bolnikih s hudo ledvično okvaro (CLcr < 30 ml/min) ni bilo dovolj podatkov, da bi lahko ocenili njen učinek na farmakokinetiko (glejte poglavji 4.2 in 4.4).
Irinotecan belongs to a group of cancer medicines called ‘topoisomerase inhibitors'.
Irinotekan spada v skupino zdravil za zdravljenje raka, imenovanih „zaviralci topoizomeraze“.
Infusion reaction
Infuzijska reakcija
Excludes asthenia and anorexia; asthenia and Grade 3 anorexia do not require dose adjustment.
Brez astenije in anoreksije; pri asteniji in anoreksiji 3. stopnje odmerka ni treba prilagoditi.
Forty-one percent (41%) of patients treated with ONIVYDE pegylated liposomal across the clinical program were ≥ 65 years.
Enainštirideset odstotkov (41 %) bolnikov, zdravljenih z zdravilom ONIVYDE pegilirani liposomski v kliničnem programu, je bilo starih ≥ 65 let.
This needs to be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija.
Patients with UGT1A1 allele
Bolniki z alelom UGT1A1
As soon as the first liquid stool occurs, the patient should start drinking large volumes of beverages containing electrolytes.
Ob prvem pojavu tekočega blata mora bolnik začeti piti večje količine pijač z elektroliti.
No data are available in patients with total bilirubin more than 2 times the ULN.
Podatki za bolnike s skupnim bilirubinom, ki je več kot 2-krat višji od ULN, niso na voljo.
In single and repeated dose toxicity studies in mice, rats and dogs, the target organs of toxicity were the gastrointestinal tract and the hematologic system.
V študijah toksičnosti enkratnih in ponavljajočih odmerkov pri miših, podganah in psih sta bila tarčna organa toksičnosti prebavni trakt in hematološki sistem.
Your doctor will decide upon the doses you will receive.
O odmerkih, ki jih boste prejemali, bo presodil zdravnik.
Description of selected adverse reactions The following adverse reactions were observed in the NAPOLI-1 clinical study:
Opis izbranih neželenih učinkov Naslednje neželene učinke so opazili v klinični študiji NAPOLI-1:
UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity such as the UGT1A1*28 polymorphism.
UGT1A1 je manjša pri posameznikih z genetskimi polimorfizmi, ki povzročajo zmanjšano aktivnost encima, kot je polimorfizem UGT1A1*28.
Table 4: Efficacy results from NAPOLI-1 clinical study
Preglednica 4 Rezultati učinkovitosti iz klinične študije NAPOLI-1
History of severe hypersensitivity to irinotecan or to any of the excipients listed in section 6.1.
Anamneza hude preobčutljivosti na irinotekan ali katero koli pomožno snov, navedeno v poglavju 6.1.
Maximum supportive care should be instituted to prevent dehydration due to diarrhoea and to treat any infectious complications.
Treba je uvesti maksimalno podporno nego, s katero preprečimo dehidracijo zaradi driske in zdravimo zaplete zaradi okužb.
In the intent to treat (all randomised) population, the median age was 63 years (range 31-87 years), 57 % were males, and 61% were Caucasian and 33% were Asian.
V populaciji z namenom zdravljenja (celotni randomizirani populaciji) je bila mediana starost 63 let (razpon 31 - 87 let), 57 % je bilo moških ter 61 % oseb kavkazijskega porekla in 33 % oseb azijskega porekla.
Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic medicinal products including ONIVYDE pegylated liposomal may result in serious or fatal infections; therefore vaccination with a live vaccine should be avoided.
Dajanje živih ali atenuiranih cepiv bolnikom z oslabljenim imunskim sistemom zaradi kemoterapevtskih zdravil, vključno z zdravilom ONIVYDE pegilirani liposomski, lahko povzroči resne ali smrtne okužbe, zato se je treba cepljenju z živimi cepivi izogibati.
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Cholesterol
1,2-distearoil-sn-glicero-3-fosfoholin (DSPC) holesterol
It is recommended that patients receive pre-medication with standard doses of dexamethasone (or an equivalent corticosteroid) together with a 5-HT3 antagonist (or other antiemetic) at least 30 minutes prior to ONIVYDE pegylated liposomal infusion.
Priporoča se, da bolniki prejmejo premedikacijo s standardnimi odmerki deksametazona (ali enakovrednega kortikosteroida), skupaj z antagonistom 5-HT3 (ali drugim antiemetikom), vsaj 30 minut pred infuzijo zdravila ONIVYDE pegilirani liposomski.
This prevents the cancer cells from multiplying and growing, and they eventually die.
Tako prepreči razmnoževanje in rast rakavih celic, ki sčasoma odmrejo.
Diarrhoea can occur early (onset in ≤ 24 hours after starting ONIVYDE pegylated liposomal) or late (> 24 hours) (see section 4.8).
Driska se lahko pojavi zgodaj (v ≤ 24 urah po začetku zdravljenja z zdravilom ONIVYDE pegilirani liposomski) ali pozno (> 24 ur) (glejte poglavje 4.8).
Risk factors include pre-existing lung disease, use of pneumotoxic medicinal products, colony stimulating factors or having previously received radiation therapy.
Dejavniki tveganja vključujejo obstoječo pljučno bolezen, uporabo pnevmotoksičnih zdravil, kolonije stimulirajočih faktorjev in predhodno zdravljenje z obsevanjem.
For Grade 1 and 2 toxicities there are no dose modifications recommended.
Pri toksičnosti 1. in 2. stopnje spreminjanje odmerka ni potrebno.
Direct measurement of irinotecan shows that 95% of irinotecan remains liposome-encapsulated during circulation.
Neposredno merjenje liposomskega irinotekana kaže, da 95 % irinotekana v obtoku ostane inkapsuliranega v liposomu.
Overall Survival Number of deaths, n (%) Median OS (months) (95% CI)
Število smrti, n (%) Mediana OS (meseci) (95-odstotni IZ)
However, in other studies with irinotecan they have been shown to be devoid of any mutagenic potential in the Ames test.
V drugih študijah z irinotekanom z Amesovim testom niso opazili mutagenega potenciala.
Toxicity grade (value) by NCI CTCAE v 4.01
toksičnosti po NCI CTCAE v 4.01
If ONIVYDE pegylated liposomal is used during pregnancy or if the patient becomes pregnant while receiving therapy, the patient should be informed about the potential hazard to the foetus.
Če zdravilo ONIVYDE pegilirani liposomski uporabljamo med nosečnostjo ali če bolnica zanosi med zdravljenjem, jo je treba obvestiti o možni nevarnosti za plod.
Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
Zdravljenje metastatskega adenokarcinoma trebušne slinavke v kombinaciji s 5-fluorouracilom (5-FU) in levkovorinom (LV) pri odraslih bolnikih, pri katerih je bolezen po zdravljenju na osnovi gemcitabina napredovala.
Neutropenia/leukopenia
Nevtropenija/levkopenija
Cytotoxic: handle with caution and special disposal.
Citotoksično: ravnajte previdno; posebno odstranjevanje.
Caution is required when ONIVYDE pegylated liposomal is given in combination with other hepatotoxic medicinal products, especially in patients with pre-existing hepatic impairment.
Previdnost je potrebna, če zdravilo ONIVYDE pegilirani liposomski dajemo v kombinaciji z drugimi hepatotoksičnimi zdravili, zlasti v primeru obstoječe okvare jeter.
The use of ONIVYDE pegylated liposomal in patients with significant renal impairment has not been established (see section 5.2).
Uporaba zdravila ONIVYDE pegilirani liposomski pri bolnikih s pomembno ledvično okvaro ni bila ocenjena (glejte poglavje 5.2).
SN-38 is approximately 1,000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumour cell lines.
SN-38 je približno 1.000-krat močnejši kot irinotekan kot zaviralec topoizomeraze I, očiščene iz tumorskih celičnih linij človeka in glodavcev.
ONIVYDE pegylated liposomal must not be used instead of other medicines containing irinotecan because it behaves differently when it is contained in the liposomes than when it is given in its free form.
Zdravila ONIVYDE pegilirani liposomski ne smete uporabljati namesto drugih zdravil, ki vsebujejo irinotekan, ker zaprt v liposome deluje drugače kot v prosti obliki.
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX19
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX19
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 farmakokinetična analiza pri bolnikih, starih med 28 in 87 leti, od katerih jih je bilo 11 % starih ≥ 75 let, kaže, da starost nima klinično pomembnega učinka na izpostavljenost irinotekanu in
Patients with deficient glucuronidation of bilirubin, such as those with Gilbert's syndrome, may be at greater risk of myelosuppression when receiving therapy with ONIVYDE pegylated liposomal.
Bolniki s pomanjkljivo glukuronidacijo bilirubina, kot so bolniki z Gilbertovim sindromom, imajo med zdravljenjem z zdravilom ONIVYDE pegilirani liposomski lahko večje tveganje za mielosupresijo.
The dose concentration and strength are different in comparison to non-liposomal irinotecans.
Koncentracija in jakost odmerka sta v primerjavi z neliposomskimi irinotekani drugačni.
If loose stools persist, contact your doctor.
Če mehko blato vztraja, se obrnite na zdravnika.
SN-38 is subsequently conjugated predominantly by the enzyme UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite.
SN-38 se nato konjugira, večinoma z encimom UDP-glukuronozil-transferazo 1A1 (UGT1A1), da nastane glukuronidni presnovek.
In clinical trials, ONIVYDE pegylated liposomal was administered at doses up to 210 mg/m to patients with various cancers.
V kliničnih preskušanjih so zdravilo ONIVYDE pegilirani liposomski dajali v odmerkih do 210 mg/m2 bolnikom z različnimi vrstami raka.
Individuals who are 7/7 homozygous for the UGT1A1*28 allele are at increased risk for neutropenia from non-liposomal irinotecan.
Posamezniki s homozigotnostjo 7/7 za alel UGT1A1*28 imajo povečano tveganje za nevtropenijo v primerjavi z neliposomskim irinotekanom.
Irinotecan is metabolized by carboxylesterase to SN-38.
Irinotekan se presnavlja s karboksilesterazo do SN-38.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 43mg/10 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 43 mg/10 ml