FrancophonIA/ELRC3.0 huggingface dataset:
English: In Phase 2 studies, this increase was dose-dependent.
Slovenian: V študijah 2. faze je bilo to povečanje odvisno od odmerka.
English: Duration of follow-up ranged up to 55 months.
Slovenian: Obdobje spremljanja je trajalo do 55 mesecev.
English: Human IgG1 crosses the placental barrier.
Slovenian: Humani IgG1 prehaja preko placentarne bariere.
English: Table 9: Overall survival in observational studies
Slovenian: Preglednica 9: Celokupno preživetje v opazovalnih študijah
English: Number of Patients (%)
Slovenian: Število bolnikov (%)
English: a gp100 peptide vaccine is an experimental control.
Slovenian: Peptidno cepivo gp100 je eksperimentalna kontrola.
English: widespread/intense pruritus regardless of etiology
Slovenian: razširjeno/intenzivno srbenje ne glede na etiologijo
English: All patients were followed for at least 1 year.
Slovenian: Vse bolnike so spremljali najmanj 1 leto.
English: Do not try to treat your symptoms with other medicines.
Slovenian: Simptomov ne poskušajte zdraviti z drugimi zdravili.
English: No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Slovenian: O razlikah v varnosti in učinkovitosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let) niso poročali.
English: Responses are summarised in Table 11.
Slovenian: Povzetek odzivov je prikazan v preglednici 11.
English: The primary efficacy endpoint was 1-year survival rate.
Slovenian: Primarni opazovani dogodek učinkovitosti je bil delež 1-letnega preživetja.
English: Age ≥ 12 to 21 years
Slovenian: Starost ≥12 do 21 let
English: In CA184178, deaths were reported at least 90 days of the last dose.
Slovenian: V študiji CA184178 so o smrtnih izidih poročali najmanj 90 dni po zadnjem odmerku.
English: Age 12 to < 18 years
Slovenian: Starost 12 do < 18 let
English: Children younger than 12 years of age
Slovenian: Otroci, mlajši od 12 let
English: Tumor assessment was performed at Week 12.
Slovenian: Vrednotenje tumorja je bilo izvedeno v 12. tednu.
English: The most common clinical presentation includes headache and fatigue.
Slovenian: Najpogostejša klinična slika vključuje glavobol in utrujenost.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA samo za enkratno uporabo
English: The median age was 57 years.
Slovenian: Mediana starost je bila 57 let.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe YERVOY are provided with the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo YERVOY, prejeli:
English: Adults and adolescents 12 years of age and older
Slovenian: Odrasli in mladostniki, stari 12 let in starejši
English: Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer.
Slovenian: Zdravljenje mora uvesti in nadzirati zdravnik specialist z izkušnjami pri zdravljenju raka.
English: Permanent discontinuation of treatment or withholding of doses
Slovenian: Trajna ukinitev zdravljenja ali zadržanje odmerkov
English: Additional efficacy results are presented in Table 13.
Slovenian: Dodatni rezultati učinkovitosti so prikazani v preglednici 13.
English: Age (2-87 years) had no clinically important effect on the CL of ipilimumab.
Slovenian: Starost (2-87 let) ni imela klinično pomembnega vpliva na očistek ipilimumaba.
English: Data presented in those sections primarily reflect experience from a Phase 3 study, MDX010-20.
Slovenian: Podatki v teh poglavjih se v glavnem nanašajo na izkušnje iz študije 3. faze, MDX010-20.
English: a. Summary of the safety profile
Slovenian: a. Povzetek profila varnosti
English: The final concentration should range from 1 to 4 mg/ml.
Slovenian: Končna koncentracija mora biti v razponu od 1 do 4 mg/ml.
English: Deaths for pediatric patients are those with on-study events within 30 days of the last dose, except for “All Deaths,” which were >30 days after the last dose.
Slovenian: Smrtni izidi pri pediatričnih bolnikih so tisti dogodki med trajanjem študije, do katerih je prišlo v 30 dneh po zadnjem odmerku, razen za “Vsi smrtni izidi”, do katerih je prišlo v > 30 dneh po zadnjem odmerku.
English: - inflammation of the eyes.
Slovenian: - vnetje oči.
English: Not reached (5.2, NE)
Slovenian: Ni dosežena (5,2; NE)
English: Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Korea
Slovenian: Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Koreja
English: The amount of YERVOY you will be given will be calculated based on your body weight.
Slovenian: Količina zdravila YERVOY, ki jo boste prejeli, se izračuna na osnovi vaše telesne mase.
English: if you have recently been prescribed Zelboraf (vemurafenib, another medicine for the treatment of skin cancer).
Slovenian: če so vam nedavno predpisali zdravilo Zelboraf (vemurafenib, drugo zdravilo za zdravljenje kožnega raka).
English: For instructions on the preparation and handling of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede priprave in ravnanja z zdravilom pred dajanjem glejte poglavje 6.6.
English: Disease specific precautions
Slovenian: Za bolezen specifični previdnostni ukrepi
English: Table 3C:
Slovenian: Preglednica 3C:
English: The study enrolled 13 patients < 12 of age and 20 patients ≥ 12 years of age.
Slovenian: V študijo je bilo vključenih 13 bolnikov, starih < 12 let, in 20 bolnikov, starih ≥ 12 let.
English: If there are signs of adrenal insufficiency but the patient is not in adrenal crisis, further investigations should be considered including laboratory and imaging assessment.
Slovenian: Če so prisotni znaki insuficience nadledvične žleze, vendar pa bolnik ni v adrenalni krizi, je treba razmisliti o nadaljnjih preiskavah, vključno z laboratorijskimi in slikovnimi.
English: Date of first authorisation: 13 July 2011 Date of latest renewal: 21 April 2016
Slovenian: Datum zadnjega podaljšanja: 21. april 2016
English: In clinical trials, patients received up to 20 mg/kg without apparent toxic effects.
Slovenian: V kliničnih preskušanjih so bolniki zdravilo prejemali v odmerkih do 20 mg/kg brez očitnih toksičnih učinkov.
English: Median duration of responseg
Slovenian: Mediana trajanja odzivag
English: Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Slovenian: Pripravo raztopine za infundiranje mora izvesti ustrezno usposobljena oseba v skladu s pravili dobre prakse, še posebej glede aseptičnih pogojev.
English: Appropriate hormone replacement should also be initiated.
Slovenian: Začeti je treba tudi z ustreznim nadomeščanjem hormonov.
English: • Obligation to conduct post-authorisation measure
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
English: There are no data on the use of ipilimumab in pregnant women.
Slovenian: Podatkov o uporabi ipilimumaba pri nosečnicah ni.
English: Tapering should occur over a period of at least 1 month.
Slovenian: Odmerek je treba zmanjševati v obdobju vsaj enega meseca.
English: Long-term hormone replacement therapy may be necessary.
Slovenian: Morda bo potrebno dolgotrajno hormonsko nadomestno zdravljenje.
English: Skin:
Slovenian: Koža:
English: As the subgroups analysis includes only small numbers of patients, no definitive conclusions can be drawn from these data.
Slovenian: Ker je analiza po podskupinah vključevala le manjše število bolnikov, iz teh podatkov ni mogoče podati zanesljivih zaključkov.
English: Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 United States
Slovenian: Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 Združene države Amerike
English: 14 months
Slovenian: 14 mesecev
English: The majority had received all 4 doses during induction.
Slovenian: Večina bolnikov je med indukcijo prejela vse 4 odmerke.
English: Rare proteinuriad
Slovenian: Redki proteinurijad
English: if you are taking any medicines that stop your blood from clotting (anticoagulants).
Slovenian: če jemljete katero koli zdravilo za preprečevanje nastanka krvnih strdkov (antikoagulanti).
English: No. at Risk mg/kg 965 429 127 73 41 29 28 12 8 4 0
Slovenian: Št. ogroženih oseb mg/kg 965 429 127 73 41 29 28 12 8 4 0
English: The development or maintenance of clinical activity following ipilimumab treatment was similar with or without the use of systemic corticosteroids.
Slovenian: Razvoj in vzdrževanje klinične aktivnosti po zdravljenju z ipilimumabom je bil podoben ob uporabi sistemskih kortikosteroidov ali brez.
English: The primary endpoints were safety and pharmacokinetics (PK).
Slovenian: Primarna opazovana dogodka sta bila varnost in farmakokinetika.
English: You should not be given YERVOY if you are allergic to ipilimumab or any of the other ingredients of this medicine (listed in Section 6 "Contents of the pack and other information").
Slovenian: Zdravila YERVOY ne smete prejeti če ste alergični na ipilimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6 "Vsebina pakiranja in dodatne informacije").
English: YERVOY should not be frozen.
Slovenian: Zdravila YERVOY ne smete zamrzovati.
English: Key elements for the Patient Information Brochure and Alert Card:
Slovenian: Ključni elementi vodnika z informacijami za bolnike in opozorilne kartice:
English: Because of the limited number of patients in these analyses, no definitive conclusion regarding the efficacy of ipilimumab re-treatment can be drawn.
Slovenian: Zaradi majhnega števila bolnikov, vključenih v te analize, dokončnih zaključkov o učinkovitosti ipilimumaba pri ponovnem zdravljenju ni mogoče podati.
English: Symptomatic treatment (e.g. loperamide, fluid replacement) and close monitoring are advised.
Slovenian: Priporočljivo je simptomatsko zdravljenje (npr. loperamid, nadomeščanje tekočine) in skrben nadzor.
English: The effects of ipilimumab on prenatal and postnatal development were investigated in a study in cynomolgus monkeys.
Slovenian: Vpliv ipilimumaba na prenatalni in postnatalni razvoj so raziskovali v študiji pri opicah cynomolgus.
English: What you need to know before you use YERVOY 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo YERVOY 3.
English: Additional information about these potentially inflammatory adverse reactions is provided in “Description of selected adverse reactions” and section 4.4.
Slovenian: Dodatne informacije o teh potencialno vnetnih neželenih učinkih so na voljo v poglavju »Opis izbranih neželenih učinkov« in v poglavju 4.4.
English: What YERVOY is and what it is used for 2.
Slovenian: Kaj je zdravilo YERVOY in za kaj ga uporabljamo 2.
English: However, for women above 50 years of age, the data supporting an OS benefit of ipilimumab treatment were limited.
Slovenian: Pri ženskah, starejših od 50 let, pa je podatkov, ki podpirajo korist zdravljenja z ipilimumabom na celokupno preživetje, malo.
English: Severe or life-threatening adverse reactions
Slovenian: Hudi ali življenjsko nevarni neželeni učinki
English: Overall Survival (proportion)
Slovenian: Celokupno preživetje (delež)
English: loosening of membrane at the back of the eye (serous retinal detachment)
Slovenian: odstopanje membrane na zadnji strani očesa (serozni odstop mrežnice)
English: Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis.
Slovenian: Bolnike s srčnimi ali srčno-pljučnimi simptomi je treba ovrednotiti glede možnega miokarditisa.
English: - Inflammation or problems with your kidneys.
Slovenian: - vnetje ali težave z ledvicami.
English: Until administration of all 4 doses or 16 weeks from first dose, whichever occurs earlier.
Slovenian: Do aplikacije vseh 4 odmerkov ali 16 tednov od prvega odmerka, karkoli nastopi prej.
English: Advanced Melanoma and NonMelanoma Solid Tumors
Slovenian: Napredovali melanom in nemelanomski solidni tumorji
English: How to use YERVOY 4.
Slovenian: Kako uporabljati zdravilo YERVOY 4.
English: A summary of adverse events in adolescents 12 years of age and older, as well as adults, is presented in Table 7.
Slovenian: Povzetek neželenih učinkov pri mladostnikih, starih 12 let in starejših, in odraslih je prikazan v preglednici 7.
English: Thus, the effect of ipilimumab on male and female fertility is unknown.
Slovenian: Učinek ipilimumaba na plodnost pri moških in ženskah ni znan.
English: - Problems with your lungs such as breathing difficulties or cough.
Slovenian: - težave s pljuči, kot so težave z dihanjem ali kašelj.
English: Fertility studies have not been performed.
Slovenian: Študije vplivov na plodnost niso bile izvedene.
English: Early diagnosis and appropriate management are essential to minimise life-threatening complications.
Slovenian: Zgodnje odkritje in ustrezno ukrepanje sta nujna za zmanjšanje pojavnosti življenjsko nevarnih zapletov.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available post-marketing data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Patients were enrolled regardless of their baseline BRAF mutation status.
Slovenian: Bolniki so bili vključeni ne glede na status mutacije BRAF.
English: Median time to response Months (range)
Slovenian: Mediana časa do odziva Meseci (razpon)
English: Adrenal crisis as a cause of the patient's symptoms must be excluded.
Slovenian: Pri bolniku je kot vzrok simptomov treba izključiti adrenalno krizo.
English: CTLA-4 blockade can also reduce T-regulatory cell function, which may contribute to an anti-tumour immune response.
Slovenian: Z zavrtjem CTLA-4 se lahko zmanjša tudi regulatorna funkcija celic T, kar lahko prispeva k protitumorskemu imunskemu odzivu.
English: Neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
Slovenian: Pojavnost nevtralizirajočih protiteles proti ipilimumabu je bila v razponu od 0 % do 0,3 %.
English: More than one vial may be necessary to obtain the required dose.
Slovenian: Za potreben odmerek bo morda treba uporabiti več kot eno vialo.
English: Exposures in adolescents are comparable with those in adults receiving the same mg/kg dose.
Slovenian: Pri mladostnikih je bila izpostavljenost primerljiva z izpostavljenostjo pri odraslih, ki so prejemali enak odmerek v mg/kg.
English: - problems with your heart such as a change in the rhythm or rate of the heartbeat or an abnormal heart rythm.
Slovenian: - težave s srcem, kot so spremembe ritma ali hitrosti utripanja srca ali nenormalen srčni ritem.
English: No other endocrine abnormalities were reported.
Slovenian: O drugih endokrinih nepravilnostih niso poročali.
English: Attribution to ipilimumab reported as Possible, Probable, Definite, or Missing for CA184178 and Adult Safety Pool, and Related or Missing for CA184070.
Slovenian: Atributi za ipilimumab so navedeni kot možni, verjetni, določni ali manjkajoči za študijo CA184178 in združene podatke o varnosti pri odraslih ter povezani ali manjkajoči za študijo CA184070.
English: Management recommendations for diarrhoea or colitis are based on severity of symptoms (per NCI-CTCAE v4 severity grading classification).
Slovenian: Priporočila za ukrepanje v primeru driske ali kolitisa temeljijo na resnosti simptomov (po klasifikaciji stopenj resnosti NCI-CTCAE v4).
English: In the two observational studies, 12.1% and 33.1% of the patients had brain metastases at the time of advanced melanoma diagnosis.
Slovenian: V dveh opazovalnih študijah je imelo 12,1 % oz. 33,1 % pacientov ob postavitvi diagnoze napredovalega melanoma metastaze v možganih.
English: YERVOY is not recommended during pregnancy or in women of childbearing potential not using effective contraception, unless the clinical benefit outweighs the potential risk.
Slovenian: Zdravila YERVOY ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, razen v primeru, ko klinična korist odtehta možno tveganje.
English: Renal Cell Carcinoma (RCC)
Slovenian: Karcinom ledvičnih celic (RCC)
English: Assessment of tumour response to ipilimumab was conducted at approximately Week 12, after completion of induction therapy.
Slovenian: Vrednotenje odziva tumorja na zdravljenje z ipilimumabom je bilo opravljeno približno v 12. tednu, po dokončanem indukcijskem zdravljenju.
English: Skin: Moderate to severe (Grade 3)b skin rash or (Grade 2)
Slovenian: Koža: zmeren do hud (stopnja 3)b kožni izpuščaj ali (stopnja 2)
English: The use of anticoagulants is known to increase the risk of gastrointestinal haemorrhage.
Slovenian: Znano je, da se pri uporabi antikoagulantov poveča tveganje za pojav gastrointestinalne krvavitve.
English: YERVOY has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo YERVOY ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: The adverse reaction mostly responded well to treatment with corticosteroids.
Slovenian: Neželeni učinek se je večinoma dobro odzval na zdravljenje s kortikosteroidi.
English: • Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen.
Slovenian: • Opis glavnih simptomov imunsko pogojenih neželenih učinkov in pomembnost takojšnjega obveščanja zdravnika, če se ti neželeni učinki pojavijo, vztrajajo ali poslabšajo.
English: Overall survival (OS) was also evaluated.
Slovenian: Vrednotili so tudi celokupno preživetje.
English: A total of 77 patients had a history of previously treated brain metastases.
Slovenian: Skupaj 77 bolnikov je imelo v anamnezi predhodno zdravljene zasevke v možganih.
English: See section 4.4 for detailed management guidelines.
Slovenian: Za podrobne smernice za ukrepanje glejte poglavje 4.4.
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and need to be addressed immediately
Slovenian: • Informacija, da lahko ipilimumab povzroči resne neželene učinke na številnih delih telesa, ki lahko povzročijo smrt in jih je treba nemudoma začeti zdraviti.
English: Most patients were male (58%) and white (92%).
Slovenian: Večina bolnikov je bilo moškega spola (58 %) in belcev (92 %).
English: These medicines may interfere with the effect of YERVOY.
Slovenian: Ta zdravila lahko vplivajo na učinek zdravila YERVOY.
English: MedDRA v.17.0 for CA184070, v.19.0 for CA184178, and V.12.1 for Adult Safety Pool.
Slovenian: MedDRA različica 17.0 za študijo CA184070, različica 19.0 za študijo CA184178 in različica 12.1 za združene podatke o varnosti pri odraslih.
English: The relationship of these malformations to treatment is unclear.
Slovenian: Povezava med temi razvojnimi nepravilnostmi in uporabo zdravila ni jasna.
English: • Brief introduction to ipilimumab (and the purpose of this risk minimisation tool).
Slovenian: • Kratka predstavitev ipilimumaba (in namen tega vodnika).
English: It is available in packs containing either 1 glass vial of 10 ml or 1 glass vial of 40 ml.
Slovenian: Zdravilo je na voljo v pakiranjih, ki vsebujejo 1 stekleno vialo z 10 ml zdravila ali 1 stekleno vialo s 40 ml zdravila.
English: (HR 0.89 with a 95% CI of 0.76, 1.04 and log-rank test P-value = 0.1548).
Slovenian: (HR 0,89 s 95 % intervalom zaupanja: 0,76; 1,04 in log-rank test P-vrednost = 0,1548).
English: Transfer the concentrate into a sterile, evacuated glass bottle or intravenous bag (PVC or non-PVC).
Slovenian: Koncentrat prenesite v sterilno, izpraznjeno intravensko infuzijsko steklenico ali vrečko (PVC ali ne-PVC tipa).
English: Before you are given YERVOY, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids.
Slovenian: Preden prvič prejmete zdravilo YERVOY, obvestite zdravnika, če jemljete katero koli zdravilo, ki deluje zaviralno na imunski sistem, kot so na primer kortikosteroidi.
English: The effects of YERVOY in pregnant women are not known, but it is possible that the active substance, ipilimumab, could harm an unborn baby.
Slovenian: Učinki zdravila YERVOY pri nosečnici niso znani, vendar pa obstaja možnost, da učinkovina ipilimumab škoduje nerojenemu otroku.
English: Assessments of tumour response should be conducted only after completion of induction therapy.
Slovenian: Vrednotenje odziva tumorja je treba izvesti šele po zaključenem indukcijskem zdravljenju.
English: if you have previously experienced a severe skin adverse reaction on a prior cancer therapy.
Slovenian: če se je pri vas pri predhodnem zdravljenju raka že kdaj pojavila huda kožna reakcija.
English: It is currently unknown if the corticosteroid treatment reverses the gland dysfunction.
Slovenian: Trenutno ni znano, če zdravljenje s kortikosteroidi obnovi delovanje žleze.
English: Other side effects that have been reported (frequency not known) with ipilimumab in combination with nivolumab include:
Slovenian: Drugi neželeni učinki, o katerih so poročali (njihova pogostnost ni znana) pri uporabi ipilimumaba v kombinaciji z nivolumabom, so:
English: Upon repeated dosing of ipilimumab administered every 3 weeks, CL was found to be time-invariant, and minimal systemic accumulation was observed as evident by an accumulation index 1.5 fold or less.
Slovenian: Pri ponavljajočem se odmerjanju ipilimumaba na vsake 3 tedne so ugotovili, da se očistek ne spreminja s časom, opaženo pa je bilo tudi minimalno sistemsko kopičenje, kar je razvidno iz indeksa akumulacije 1,5-krat ali manj.
English: Vogt-Koyanagi-Harada syndromeh
Slovenian: Sindrom Vogt-Koyanagi-Haradah
English: Very rare (may affect up to 1 in 10,000 people) Serious, potential life-threatening allergic reaction
Slovenian: Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov) resne alergijske reakcije, ki so lahko smrtno nevarne
English: Be aware of important symptoms of inflammation YERVOY acts on your immune system and may cause inflammation in parts of your body.
Slovenian: Bodite pozorni na pomembne simptome vnetja Zdravilo YERVOY deluje na imunski sistem in lahko povzroči vnetje na posameznih delih telesa.
English: What YERVOY is and what it is used for
Slovenian: Kaj je zdravilo YERVOY in za kaj ga uporabljamo
English: Calculating the dose:
Slovenian: Določitev odmerka:
English: What you need to know before you use YERVOY
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo YERVOY
English: NA = not assessed For adults, deaths reported in this table are within 70 days of the last dose, regardless of relationship.
Slovenian: Pri odraslih je do smrtnih izidov, navedenih v tej preglednici, prišlo v 70 dneh po zadnjem odmerku, ne glede na povezavo.
English: For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po prvem odprtju ali redčenju zdravila glejte poglavje 6.3.
English: These medicines may increase the likelihood of bleeding in the stomach or intestine, which is a sideeffect of YERVOY.
Slovenian: Ta zdravila lahko povečajo verjetnost za pojav krvavitev v želodcu ali črevesu, kar je neželeni učinek zdravila YERVOY.
English: Other medicines and YERVOY
Slovenian: Druga zdravila in zdravilo YERVOY
English: Cmax, Cmin and AUC of ipilimumab were found to be dose proportional within the dose range examined.
Slovenian: Vrednosti Cmax, Cmin in AUC ipilimumaba so bile v preiskovanem razponu odmerkov proporcionalne z odmerkom.
English: 10 months
Slovenian: 10 mesecev
English: Based on a population PK analysis using available pooled data from 565 patients from 4 phase 2 adult studies (N=521) and 2 paediatric studies (N=44), CL of ipilimumab increased with increasing baseline body weight.
Slovenian: Na osnovi analize populacijske farmakokinetike z uporabo razpoložljivih združenih podatkov pri 565 bolnikih iz 4 študij 2. faze pri odraslih (N=521) in 2 pediatričnih študij (N=44) se očistek ipilimumaba povečuje s povečevanjem izhodiščne telesne mase.