natgillin/translations-raw huggingface dataset:
The safety and efficacy of ONIVYDE pegylated liposomal were investigated in a multinational, randomised, open label, controlled clinical trial (NAPOLI-1) that tested two treatment regimens for patients with metastatic pancreatic adenocarcinoma who had documented disease progression after gemcitabine or gemcitabine-containing therapy.
Varnost in učinkovitost zdravila ONIVYDE pegilirani liposomski so preučevali v večnacionalnem, randomiziranem, odprtem, nadzorovanem kliničnem preskušanju (NAPOLI-1), v katerem so preskušali dva režima zdravljenja za bolnike z metastatskim adenokarcinomom trebušne slinavke, ki so imeli dokumentirano napredovalo bolezen po zdravljenju z gemcitabinom ali zdravljenju, ki je vključevalo gemcitabin.
METHOD AND ROUTE OF ADMINISTRATION For single use only.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za enkratno uporabo.
ONIVYDE pegylated liposomal can cause harm to the foetus when administered to the pregnant woman, as the main ingredient irinotecan has been shown to be embryotoxic and teratogenic in animals (see section 5.3).
ONIVYDE pegilirani liposomski lahko škoduje plodu, če ga jemljejo nosečnice, saj je bila glavna sestavina irinotekan pri živalih dokazano embriotoksična in teratogena (glejte poglavje 5.3).
The plasma protein binding of non-liposomal irinotecan is moderate (30% to 68%), and SN-38 is highly bound to human plasma proteins (approximately 95%).
Vezava neliposomskega irinotekana na plazemske beljakovine je zmerna (30 - 68-odstotna), SN-38 pa se močno veže na plazemske beljakovine (približno 95-odstotno).
The concentrate must be diluted prior to administration and given as single intravenous infusion over 90 minutes.
Koncentrat morate pred uporabo razredčiti in ga dati v obliki enkratne intravenske infuzije, ki traja 90 minut.
• The other ingredients are: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC); cholesterol, N-(carbonyl-methoxypolyethylene glycol-2000)-1,2-distearoly-sn-glycero-3-phosphoethanolam ine (MPEG-2000-DSPE); Sucrose octasulphate; 2- [4- (2-Hydroxyethyl)piperazin-1-yl]ethanesulfonic acid (HEPES buffer); sodium chloride and water for injections.
• Druge sestavine zdravila so: 1,2-distearoil-sn-glicero-3-fosfoholin (DSPC); holesterol, N-(karbonil-metoksipolietilenglikol-2000)-1,2-distearoil-sn-glicero-3-fosfoetanolamin (MPEG-2000-DSPE); saharozni oktasulfat; 2- [4- (2-hidroksietil)piperazin-1-il]etansulfonska kislina (pufer HEPES); natrijev klorid in voda za injekcije.
There are no adequate data on the use of ONIVYDE pegylated liposomal in pregnant women.
Ni zadostnih podatkov o uporabi zdravila ONIVYDE pegilirani liposomski pri nosečnicah.
• Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.
• Potrebna je previdnost, da ne pride do ekstravazacije, mesto infuzije pa je treba spremljati glede znakov vnetja.
This active substance is held in tiny lipid (fatty) particles called liposomes.
Ta učinkovina je shranjena v majhnih lipidnih (maščobnih) delcih, imenovanih liposomi.
Before you start treatment with ONIVYDE pegylated liposomal, your doctor will perform blood tests (or other medical examinations) to determine the best starting dose for you.
Krvne preiskave in zdravstvene preiskave Pred začetkom zdravljenja z zdravilom ONIVYDE pegilirani liposomski bo zdravnik opravil krvne preiskave (ali druge zdravstvene preiskave), s katerimi bo določil za vas najprimernejši začetni odmerek.
Frequencies categories used for adverse reactions are: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000)**.
1/10); občasni (≥ 1/1.000 do < 1/100) in redki (≥ 1/10.000 do < 1/1.000)**.
You may receive pre-medication against nausea and vomiting.
Morda boste pred infuzijo prejeli zdravila proti slabosti in bruhanju.
In patients who experienced severe haematological events, a dose reduction or treatment discontinuation is recommended (see section 4.2).
Pri bolnikih, ki doživijo hude hematološke neželene učinke, se priporoča zmanjšanje odmerka ali prekinitev zdravljenja (glejte poglavje 4.2).
Excipient with known effect
Pomožna snov z znanim učinkom:
ONIVYDE pegylated liposomal is used to treat adult patients with metastatic pancreatic cancer (cancer of the pancreas that has already spread elsewhere in the body) whose previously cancer treatment included a medicine called gemcitabine.
Zdravilo ONIVYDE pegilirani liposomski se uporablja za zdravljenje odraslih bolnikov z metastatskim rakom trebušne slinavke (rakom trebušne slinavke, ki se je že razširil drugje po telesu), ki so se predhodno zdravili zaradi raka z zdravilom, imenovanim gemcitabin.
Very common: Hypokalaemia, Hypomagnesaemia, Dehydration, Decreased appetite
Zelo pogosti: hipokaliemija, hipomagneziemija, dehidracija, zmanjšan apetit
In pregnant rats there was a decrease in placental weight and in the offspring a decrease in foetal viability and increase in behavioural abnormalities.
Pri brejih podganah so opazili zmanjšano placentalno maso, pri potomstvu pa manjše preživetje plodov ter povečano pojavnost vedenjskih nepravilnosti.
In a pooled analysis from 353 patients, higher plasma SN-38 Cmax was associated with increased likelihood of experiencing neutropenia, and higher plasma total irinotecan Cmax was associated with increased likelihood of experiencing diarrhoea.
V združeni analizi 353 bolnikov je bila višja vrednost SN-38 Cmax v plazmi povezana z večjo verjetnostjo za pojav nevtropenije, višja vrednost skupnega irinotekana Cmax pa z večjo verjetnostjo za pojav driske.
You should not be given ONIVYDE pegylated liposomal if you are pregnant as it may harm the baby.
Zdravila ONIVYDE pegilirani liposomski ne smete prejemati, če ste noseči, ker lahko škoduje otroku.
In case of cholinergic symptoms atropine should be administered.
Pri bolnikih s holinergičnimi simptomi moramo uporabiti atropin.
Ask your doctor for advice if you are planning to have a baby.
Posvetujte se z zdravnikom, če načrtujete zanositev.
The urinary excretion of non-liposomal irinotecan is 11% to 20%; SN-38 < 1%; and SN-38 glucuronide is 3%.
Izločanje neliposomskega irinotekana z urinom je med 11 in 20 %, SN-38 < 1 % in glukuronida
In vitro studies indicate that irinotecan, SN-38 and another metabolite aminopentane carboxylic acid (APC) do not inhibit cytochrome P-450 isozymes.
Študije in vitro kažejo, da irinotekan, SN-38 in drug presnovek aminopentan karboksilna kislina (APC) ne zavirajo izoencimov citokroma P-450.
headache, tightness in the chest or throat - Abnormal fluid retention in the body causing swelling in the affected tissues (oedema)
tiščanje v prsih ali grlu, - nenormalno zadrževanje tekočine v telesu, ki povzroči otekanje prizadetih tkiv (edem).
This was not seen in morphologically normal pups.
Pri morfološko normalnih mladičih tega niso opazili.
Cholinergic reactions
Holinergične reakcije
Patients should not breast-feed until one month after the last dose.
Bolnice lahko začnejo dojiti šele en mesec po zadnjem odmerku.
It is unknown whether ONIVYDE pegylated liposomal or its metabolites are excreted into human milk.
Ni znano, ali se zdravilo ONIVYDE pegilirani liposomski ali njegovi presnovki izločajo v materino mleko.
Myelosuppression/neutropenia
Mielosupresija/nevtropenija
Non-liposomal irinotecan and SN-38 were genotoxic in vitro in the chromosomal aberration test on CHO-cells as well as in the in vivo micronucleus test in mice.
Neliposomski irinotekan in SN-38 sta bila genotoksična in vitro v testu kromosomskih aberacij na celicah CHO ter in vivo v testu mikronukleusov na miših.
Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
If you have experienced sweating, abdominal cramping and salivation together with early frequent and liquid stools in previous treatments with ONIVYDE pegylated liposomal, you may receive additional medicines before ONIVYDE pegylated liposomal to prevent or reduce this in the following treament cycles.
Če ste pri predhodnih zdravljenjih z zdravilom ONIVYDE pegilirani liposomski občutili znojenje, trebušne krče in slinjenje, skupaj z zgodnjim pogostim in tekočim odvajanjem blata, boste morda pred odmerkom zdravila ONIVYDE pegilirani liposomski prejeli dodatna zdravila za preprečevanje ali zmanjševanje teh učinkov v naslednjem ciklu zdravljenja.
Common: Hypotension
Pogosti: hipotenzija
Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.
Potrebna je previdnost, da ne pride do ekstravazacije, mesto infuzije pa je treba spremljati glede znakov vnetja.
ONIVYDE pegylated liposomal may influence your ability to drive and use machines (as you may be sleepy, dizzy and exhausted with the use of ONIVYDE pegylated liposomal).
Zdravilo ONIVYDE pegilirani liposomski lahko vpliva na sposobnost upravljanja vozil in strojev (ker ste zaradi uporabe zdravila ONIVYDE pegilirani liposomski lahko zaspani, omotični in izčrpani).
Table 5: Summary of mean (±standard deviation) total irinotecan and total SN-38 Analyte PK parameters
Preglednica 5: Povzetek povprečnih vrednosti (± standardni odklon) skupnega irinotekana in skupnega SN-38 Analit
Caution should be exercised when using ONIVYDE pegylated liposomal in patients with body mass index < 18.5 kg/m
Previdnost je potrebna pri uporabi zdravila ONIVYDE pegilirani liposomski pri bolnikih z indeksom telesne mase < 18,5 kg/m2.
ONIVYDE pegylated liposomal should be withheld if neutropenic fever occurs or the absolute neutrophil count drops below 1,500 cells/mm
Dajanje zdravila ONIVYDE pegilirani liposomski je treba odložiti, če se pojavi nevtropenična vročina ali če absolutno število nevtrofilcev pade pod 1.500
NCI CTCAE v 4.0 = National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
NCI CTCAE v 4.0 = Terminološko poenotena merila neželenih učinkov Nacionalnega onkološkega inštituta, različica 4.0 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0)
Common: Increased bilirubin, Increased alanine aminotransferase, Increased aspartate aminotransferase, Increased international normalised ratio
Zelo pogosti: zmanjšana telesna masa Pogosti: zvišana raven bilirubina, zvišana raven alaninaminotransferaze, zvišana raven aspartat-aminotransferaze, zvišano mednarodno umerjeno razmerje
ONIVYDE pegylated liposomal is given as a drip (infusion) into a vein, which should take at least 90 minutes and should be given as a single dose.
Zdravilo ONIVYDE pegilirani liposomski se daje s kapalno infuzijo (infundiranjem) v veno, kar mora trajati vsaj 90 minut, prejeti pa ga morate v enkratnem odmerku.
Underweight patients (body mass index < 18.5 kg/m2)
Bolniki s premajhno telesno maso (indeks telesne mase < 18,5 kg/m2)
Compared to Caucasians, Asian patients were observed with a lower incidence of diarrhoea [14 (19.2%) out of 73 Caucasians had a ≥ Grade 3 diarrhoea, and 1 out of 33 (3.3%) Asians had a ≥ Grade 3 diarrhoea], but a higher incidence and higher severity of neutropenia.
V primerjavi z bolniki kavkazijskega porekla imajo bolniki azijskega porekla manjšo pojavnost driske [drisko ≥ 3. stopnje je imelo 14 (19,2 %) od 73 bolnikov kavkazijskega porekla in 1 od 33 (3,3 %) bolnikov azijskega porekla], vendar višjo pojavnost in resnost nevtropenije.
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).
O menjavi z zdravili, ki ne inducirajo encima, je treba razmisliti vsaj 2 tedna pred začetkom zdravljenja z zdravilom ONIVYDE pegilirani liposomski (glejte poglavje 4.5).
Onivyde pegylated liposomal has been associated with thromboembolic events such as pulmonary embolism, venous thrombosis and arterial thromboembolism.
Zdravilo Onivyde pegilirani liposomski je bilo povezano s trombemboličnimi dogodki, kot so pljučna embolija, venska tromboza in arterijska trombembolija.
Strong CYP3A4 inhibitors should be discontinued at least 1 week prior to starting ONIVYDE pegylated liposomal therapy.
Zdravljenje z močnimi zaviralci encima CYP3A4 je treba prekiniti vsaj 1 teden pred začetkom zdravljenja z zdravilom ONIVYDE pegilirani liposomski.
The volume of distribution of ONIVYDE pegylated liposomal 70 mg/m was 2.6 l/m 2, which suggests that
Porazdelitveni volumen zdravila ONIVYDE pegilirani liposomski 70 mg/m2 je bil 2,6 l/m2, kar kaže,
Common: Infusion related reaction, Oedema
Pogosti: z infuzijo povezana reakcija, edem
The diluted solution is clear to slightly white to slightly opalescent and free from visible particles.
Razredčena raztopina je bistra do belkasta do rahlo mlečna in brez vidnih delcev.
Patients should be made aware of the risk of delayed diarrhoea which can be debilitating and, on rare occasions, life threatening since persistent loose or watery stools can result in dehydration, electrolyte imbalance, colitis, gastrointestinal (GI) ulceration, infection or sepsis.
Bolnike je treba opozoriti na tveganje za zapoznelo drisko, ki je izčrpavajoča in v redkih primerih tudi življenjsko nevarna, saj dolgotrajno mehko ali vodeno blato lahko privede do dehidracije, elektrolitskega neravnovesja, kolitisa, razjed v črevesju, okužbe ali sepse.
Pulmonary toxicity
Pljučna toksičnost
After you have been given ONIVYDE pegylated liposomal you will be given two other medicines, leucovorin and 5-fluorouracil.
Po prejemu zdravila ONIVYDE pegilirani liposomski boste prejeli še dve zdravili, levkovorin in 5-fluorouracil.
The pharmacokinetic parameters of total irinotecan and SN-38 analytes, following the administration of ONIVYDE pegylated liposomal 70 mg/m are presented in Table 5.
Farmakokinetični parametri analitov skupnega irinotekana in SN-38 po dajanju zdravila ONIVYDE pegilirani liposomski 70 mg/m2 so predstavljeni v preglednici 5.
Patients receiving concomitant non-liposomal irinotecan and CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital or carbamazepine have substantially reduced exposure to irinotecan (AUC reduction by 12% with St John's wort, 57%-79% with phenytoin, phenobarbital, or carbamazepine) and SN-38 (AUC reduction by 42% with St John's wort, 36%-92% with phenytoin phenobarbital, or carbamazepine).
Bolniki, ki sočasno prejemajo neliposomski irinotekan in antikonvulzive, ki inducirajo encim CYP3A4, tj. fenitoin, fenobarbital ali karbamazepin, imajo bistveno zmanjšano izpostavljenost irinotekanu (zmanjšanje AUC s šentjanževko za 12 % in s fenitoinom, fenobarbitalom in karbamazepinom za 57 - 79 %) in SN-38 (zmanjšanje AUC s šentjanževko za 42 % in s fenitoinom, fenobarbitalom in karbamazepinom za 36-92 %).
Following Grade 3 or 4 diarrhoea, the subsequent dose of ONIVYDE pegylated liposomal should be reduced, (see section 4.2).
Po driski 3. ali 4. stopnje je treba naslednji odmerek zdravila ONIVYDE pegilirani liposomski zmanjšati (glejte poglavje 4.2).
In the limited number of patients with prior exposure to non-liposomal irinotecan, no benefit of ONIVYDE pegylated liposomal has been demonstrated.
Pri omejenem številu bolnikov, ki so bili predhodno izpostavljeni neliposomskemu irinotekanu, koristen vpliv zdravila ONIVYDE pegilirani liposomski ni bil ugotovljen.
History of prior abdominal radiation increases the risk of severe neutropenia and febrile neutropenia following ONIVYDE pegylated liposomal treatment.
Anamneza predhodnega obsevanja trebuha poveča tveganje za hudo nevtropenijo in febrilno nevtropenijo po zdravljenju z zdravilom ONIVYDE pegilirani liposomski.
Non-liposomal irinotecan caused atrophy of male reproductive organs both in rats and dogs after multiple daily doses of 20 mg/kg and 0.4 mg/kg, respectively.These effects were reversible upon cessation of treatment.
Neliposomski irinotekan je povzročil atrofijo moških reproduktivnih organov pri podganah in psih po večkratnih dnevnih odmerkih 20 mg/kg oziroma 0,4 mg/kg.
In animal models, ONIVYDE pegylated liposomal has been shown to extend plasma levels of irinotecan and prolong the exposure to the active metabolite SN-38 at the site of the tumour.
V živalskih modelih so dokazali, da zdravilo ONIVYDE pegilirani liposomski zviša plazemsko raven irinotekana in podaljša izpostavljenost aktivnemu presnovku SN-38 na mestu tumorja.
[30 of 110 (27.3%)] (see section 5.1).
[13 od 73 (18 %)].
One ml of concentrate contains 0.144 mmol (3.31 mg) sodium.
En mililiter koncentrata vsebuje 0,144 mmol (3,31 mg) natrija.
Grade 3 or higher and serious treatment emergent adverse reactions were more frequent in patients < 65 years (84.1% and 50.8%) compared to patients ≥ 65 years (68.5 % and 44.4%).
(84,1 % in 50,8 %) pogostejši kot pri bolnikih, starih ≥ 65 let (68,5 % in 44,4 %).
Liposome forming lipids
Lipidi za tvorbo liposomov
This is consistent with the population pharmacokinetic analysis that showed a lower exposure to irinotecan and a higher exposure to its active metabolite SN-38 in Asians than in Caucasians.
To je skladno s populacijsko farmakokinetično analizo, ki je pokazala, da imajo osebe azijskega porekla nižjo izpostavljenost irinotekanu in višjo izpostavljenost njegovemu aktivnemu presnovku SN-38 kot bolniki kavkazijskega porekla.
• Aseptic techniques must be followed during the preparation of the infusion.
• Med pripravo infuzije morate uporabljati aseptične tehnike.
The most common adverse reactions (incidence ≥ 20%) of ONIVYDE pegylated liposomal +5-FU/LV were: diarrhoea, nausea, vomiting, decreased appetite, neutropenia, fatigue, asthenia, anaemia,
Najpogostejši neželeni učinki (pojavnost ≥ 20 %) zdravila ONIVYDE pegilirani liposomski +5FU/LV so bili: driska, navzea, bruhanje, zmanjšan apetit, nevtropenija, utrujenost, astenija, anemija,
The plasma pharmacokinetics of total irinotecan and total SN-38 were evaluated in patients with cancer who received ONIVYDE pegylated liposomal, as a single agent or as part of combination chemotherapy, at doses between 50 and 155 mg/m2.
Plazemsko farmakokinetiko skupnega irinotekana in skupnega SN-38 so ocenjevali pri bolnikih z rakom, ki so prejemali zdravilo ONIVYDE pegilirani liposomski samostojno ali kot del kombinirane kemoterapije v odmerkih med 50 in 155 mg/m2.
The plasma protein binding of ONIVYDE pegylated liposomal is negligible (< 0.44% of total irinotecan in ONIVYDE pegylated liposomal).
Vezava zdravila ONIVYDE pegilirani liposomski na plazemske beljakovine je zanemarljiva (< 0,44 % skupnega irinotekana v zdravilu ONIVYDE pegilirani liposomski).
In rats, pups born from treated animals and having external abnormalities showed a decrease in fertility.
Pri podganah so imeli mladiči, ki so se skotili živalim, ki so prejemale zdravilo, in so imeli zunanje nepravilnosti, zmanjšano plodnost.
Key eligibility criteria for patients with metastatic adenocarcinoma of the pancreas in the NAPOLI-1 clinical study were Karnofsky Performance Status (KPS) ≥ 70, normal bilirubin level, transaminase levels ≤ 2.5 times the ULN or ≤ 5 times the ULN for patients with liver metastases and albumin ≥ 3.0 g/dl.
Glavna merila primernosti bolnikov z metastatskim adenokarcinomom trebušne slinavke za vključitev v klinično študijo NAPOLI-1 so bila stanje zmogljivosti po Karnofskyju (KPS) ≥ 70, normalna raven bilirubina, raven aminotransferaz ≤ 2,5-krat ULN ali ≤ 5-krat ULN za bolnike z jetrnimi metastazami in albumin ≥ 3,0 g/dl.
ONIVYDE pegylated liposomal +5-FU/LV (N= 117)
ONIVYDE pegilirani liposomski +5-FU/LV (N= 117)
Objective Response Rate
Objektivna stopnja odziva2 N
In the clinical study, early diarrhoea onset occurred in 35 patients (29.9%) and cholinergic events occurred in 4 patients (3.4%) receiving ONIVYDE pegylated liposomal +5-FU/LV.
V klinični študiji se je zgodnja driska pojavila pri 35 bolnikih (29,9 %), holinergične reakcije pa pri 4 bolnikih (3,4 %), ki so prejemali zdravilo ONIVYDE pegilirani liposomski +5-FU/LV.
ONIVYDE pegylated liposomal is used in combination with other cancer medicines, called 5-fluorouracil and leucovorin.
Zdravilo ONIVYDE pegilirani liposomski se uporablja v kombinaciji z drugima zdraviloma za zdravljenje raka, imenovanima 5-fluorouracil in levkovorin.
ONIVYDE pegylated liposomal (irinotecan) must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies.
Zdravilo ONIVYDE pegilirani liposomski (irinotekan) smejo bolnikom predpisati in dajati samo zdravstveni delavci, ki imajo izkušnje pri uporabi zdravil za zdravljenje raka.
Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas.
V teh pogojih je bila pojavnost kombiniranih endometrijskih stromalnih polipov na materničnem rogu in endometrijskih stromalnih sarkomov linearno povezana z odmerkom.
- if you experience signs or symptoms of a blood clot, like sudden pain and swelling in a leg or an arm, sudden onset of coughing, chest pain or difficulty breathing.
- če ste brez sape ali kašljate, - če se pojavijo znaki ali simptomi krvnega strdka, kot so nenadna bolečina in otekanje v nogi ali roki, nenaden pojav kašlja, bolečine v prsih ali oteženo dihanje.
Aseptic techniques must be followed during the preparation of the infusion.
Med pripravo infuzije morate uporabljati aseptične tehnike.
Because of the potential for serious adverse reactions of ONIVYDE pegylated liposomal in breast-feeding infants, ONIVYDE pegylated liposomal is contraindicated during breast-feeding (see section 4.3).
Zaradi možnosti resnih neželenih učinkov zdravila ONIVYDE pegilirani liposomski pri dojenih otrocih je zdravilo ONIVYDE pegilirani liposomski med dojenjem kontraindicirano (glejte poglavje 4.3).
In safety pharmacology studies in dogs, ONIVYDE pegylated liposomal had no effect on cardiovascular, hemodynamic, electrocardiographic, or respiratory parameters at doses up to 18 mg/kg or 360 mg/m
V farmakoloških študijah varnosti zdravilo ONIVYDE pegilirani liposomski v odmerkih do 18 mg/kg ali 360 mg/m2 ni imelo učinka na kardiovaskularne, hemodinamske, elektrokardiografske in respiratorne parametre.
ONIVYDE pegylated liposomal is not recommended for use in patients with severe renal impairment (CLcr < 30 ml/min).
Uporaba zdravila ONIVYDE pegilirani liposomski pri bolnikih s hudo ledvično okvaro (CLcr < 30 ml/min) ni priporočljiva.
What ONIVYDE pegylated liposomal is and what it is used for What you need to know before you use ONIVYDE pegylated liposomal How ONIVYDE pegylated liposomal is used Possible side effects
Kaj je zdravilo ONIVYDE pegilirani liposomski in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ONIVYDE pegilirani liposomski Kako se uporablja zdravilo ONIVYDE pegilirani liposomski
5-FU dose modification as in Table 1
Sprememba odmerka 5-FU skladno s preglednico 1
The no-observed-adverse-effect level (NOAEL) in rats and dogs following 90 min intravenous infusion of ONIVYDE pegylated liposomal once every 3 weeks for 18 weeks was 155 mg/m
no-observed-adverse-effect level) pri podganah in psih po 90-minutni intravenski infuziji zdravila ONIVYDE pegilirani liposomski na 3 tedne, kar je trajalo skupaj 18 tednov, je bila 155 mg/m2.
Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
2- [ 4- (2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES buffer) Sodium chloride
2- [ 4- (2-hidroksietil)piperazin-1-il] etansulfonska kislina (pufer HEPES) natrijev klorid voda za injekcije
The use of ONIVYDE pegylated liposomal should be avoided in patients with bilirubin > 2.0 mg/dl, or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) or > 5 times ULN if liver metastasis is present (see section 4.4).
Uporabi zdravila ONIVYDE pegilirani liposomski se je treba izogibati pri bolnikih z vrednostjo bilirubina > 2,0 mg/dl ali > 2,5-kratno zgornjo mejo normalnih vrednosti (ULN) aspartataminotransferaze (AST) in alanin-aminotransferaze (ALT) ali > 5-kratno ULN v primeru prisotnosti jetrnih metastaz (glejte poglavje 4.4).