FrancophonIA/ELRC3.0 huggingface dataset:
English: The reconstituted, filtered and diluted suspension for infusion is a homogenous, white to off-white, opaque liposomal suspension, free of visible particles and free of foam and lipid lumps.
Slovenian: Rekonstituirana, filtrirana in razredčena suspenzija za infundiranje je homogena, bela do umazano bela, neprozorna liposomska suspenzija, ki ne vsebuje vidnih delcev, pene in lipidnih gmot.
English: After removing the needle from the syringe, the syringe should be attached to the filter by opening the filter luer connector cap (figure 1).
Slovenian: Ko iglo snamete z brizge, morate slednjo pritrditi na filter, tako da odprete pokrovček filtrskega luer nastavka (slika 1).
English: These are not expected at the recommended dose, however monitoring of clotting parameters after the first dose and once again after several doses is recommended.
Slovenian: Krvavitve pri priporočenem odmerku niso pričakovane, vendar pa je po prvem odmerku priporočljivo preveriti parametre strjevanja krvi in preiskavo po naslednjih nekaj odmerkih ponoviti.
English: Mifamurtide may be given during periods of neutropenia, but subsequent fever attributed to the treatment should be monitored closely.
Slovenian: Mifamurtid se lahko uporablja v obdobjih nevtropenije, posledično zvišano telesno temperaturo, pripisano zdravljenju, pa je treba skrbno nadzirati.
English: Chemical and physical in-use stability has been demonstrated for 6 hours at room temperature (between approximately 20 C-25 °C).
Slovenian: Ugotovljena je bila kemijska in fizikalna stabilnost pripravljene suspenzije 6 ur pri sobni temperaturi (med približno 20 C - 25 °C).
English: The maximum tolerated dose in phase I studies was 4-6 mg/m with a high variability of adverse reactions.
Slovenian: Največji še toleriran odmerek v študijah I. faze je bil 4-6 mg/m2 z zelo različnimi neželenimi učinki.
English: In patients with a history of asthma or other chronic obstructive pulmonary disease, consideration should be given to administration of bronchodilators on a prophylactic basis.
Slovenian: Pri bolniki z astmo ali drugo kronično obstruktivno pljučno boleznijo v anamnezi je treba razmisliti o profilaktični uporabi bronhodilatatorjev.
English: Each carton contains 1 vial and 1 single-use, non-pyrogenic, sterile filter for MEPACT supplied in a PVC-grade blister.
Slovenian: Ena škatla vsebuje 1 vialo in 1 nepirogeni sterilni filter za enkratno uporabo za zdravilo MEPACT, ki je priložen v PVC pretisnem omotu.
English: Talk to your doctor before using MEPACT: if you have or have had problems with your heart or blood vessels, like blood clots (thrombosis), bleeding (haemorrhage) or inflammation of the veins (vasculitis).
Slovenian: Pred začetkom uporabe zdravila MEPACT se posvetujte z zdravnikom: - če imate ali ste kdaj imeli težave s srcem ali ožiljem, na primer krvne strdke (tromboza), krvavitve (hemoragija) ali vnetje žil (vaskulitis).
English: All patients received a total dose of cisplatin of 480 mg/m2 as part of their induction (neoadjuvant) and/or maintenance (adjuvant) chemotherapy regimen.
Slovenian: Vsi bolniki so prejeli skupni odmerek cisplatina 480 mg/m2 v sklopu njihovega začetnega (neoadjuvantnega) in/ali vzdrževalnega
English: Therefore, the use of high-dose NSAIDs is contraindicated (see section 4.3).
Slovenian: Zato je uporaba visokih odmerkov nesteroidnih protivnetnih zdravil kontraindicirana (glejte poglavje 4.3).
English: if you develop chills or shivering, or feel warm.
Slovenian: - če se pojavi mrzlica, tresenje ali čutite vročino.
English: One serious incident of subacute thrombosis was reported in early studies, but no serious cardiac events were associated with mifamurtide in a large randomised controlled study (see section 4.4).
Slovenian: V zgodnjih študijah so poročali o enem resnem primeru subakutne tromboze, v obsežni randomizirani nadzorovani študiji pa z mifamurtidom niso bili povezani nobeni resni srčni dogodki (glejte poglavje 4.4).
English: After injection of radiolabelled liposomes containing mifamurtide, mean half-life of radiolabelled material was biphasic with an α-phase of about 15 minutes and a terminal half-life of approximately 18 hours.
Slovenian: Po injiciranju z radioaktivnim izotopom označenih liposomov, ki so vsebovali mifamurtid, je bil povprečni razpolovni čas z radioaktivnim izotopom označenega materiala dvofazen, pri čemer je α-faza trajala približno 15 minut, končni razpolovni čas pa približno 18 ur.
English: Metabolism of liposomal MTP-PE has not been studied in humans.
Slovenian: Presnove liposomskega MTP-PE pri človeku niso raziskovali.
English: MEPACT is a liposomal formulation specifically designed for in vivo targeting to macrophages by intravenous infusion.
Slovenian: Zdravilo MEPACT je liposomska formulacija, posebej zasnovana za in vivo ciljanje makrofagov z intravensko infuzijo.
English: Like all medicines, MEPACT can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: How to use MEPACT
Slovenian: Kako uporabljati zdravilo MEPACT
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na enoto odmerka.
English: See section 2 “MEPACT contains sodium”
Slovenian: Glejte poglavje 2 Zdravilo MEPACT vsebuje natrij
English: It is unknown whether mifamurtide is excreted in human milk.
Slovenian: Ni znano, če se mifamurtid izloča v materino mleko.
English: However, as the variability in pharmacokinetics of mifamurtide is greater in subjects with moderate hepatic impairment (see section 5.2), and safety data in patients with moderate hepatic impairment is limited, caution when administering mifamurtide to patients with moderate hepatic impairment is recommended.
Slovenian: Ker pa je pri osebah z zmerno okvaro jeter variabilnost farmakokinetike mifamurtida večja (glejte poglavje 5.2), podatki o varnosti pri bolnikih z zmerno okvaro jeter pa omejeni, je pri bolnikih z zmerno okvaro jeter treba mifamurtid vseeno uporabljati previdno.
English: From a microbiological point of view, immediate use is recommended.
Slovenian: Z mikrobiološkega stališča je priporočljivo, da zdravilo uporabite takoj.
English: The PIL should be updated accordingly.
Slovenian: Navodilo za uporabo je treba ustrezno posodobiti.
English: Before using MEPACT, you should discuss with your doctor whether you should take medicine for your asthma when using MEPACT.
Slovenian: Pred uporabo zdravila MEPACT se posvetujte z zdravnikom, če morate med zdravljenjem z zdravilom MEPACT jemati zdravilo za zdravljenje astme.
English: At 6 hours after injection of radiolabelled liposomes containing 1 mg mifamurtide, radioactivity was found in liver, spleen, nasopharynx, thyroid, and, to a lesser extent, in lung.
Slovenian: Šest ur po injiciranju z radioaktivnim izotopom označenih liposomov, ki so vsebovali 1 mg mifamurtida, je bila radioaktivnost zaznana v jetrih, vranici, nazofarinksu, ščitnici in v manjši meri v pljučih.
English: Once reconstituted in sodium chloride 9 mg/mL (0.9%) solution, store at room temperature (approximately 20ºC - 25ºC) and use within 6 hours.
Slovenian: Rekonstituirano suspenzijo v raztopini natrijevega klorida 9 mg/ml (0,9%) hranite pri sobni temperaturi (približno 20 ºC - 25 ºC) in porabite v 6 urah.
English: In vitro-treated human monocytes killed allogeneic and autologous tumour cells (including melanoma, ovarian, colon, and renal carcinoma), but had no toxicity towards normal cells.
Slovenian: Človeški monociti, obravnavani in vitro, so uničili alogenske in avtologne tumorske celice (vključno z melanomom, ovarijskim karcinomom, karcinomom kolona in ledvičnim karcinomom), niso pa bili toksični za normalne celice.
English: In 28 osteosarcoma patients aged 6 to 39 years serum total (liposomal and free) mifamurtide concentrations declined rapidly with a mean half-life of 2.04 ± 0.456 hours.
Slovenian: Pri 28 bolnikih z osteosarkomom, starih od 6 do 39 let, so se koncentracije skupnega mifamurtida (liposomskega in prostega) v serumu hitro zmanjševale s povprečnim razpolovnim časom 2,04 ± 0,456 ure.
English: Limited studies of the interaction of mifamurtide with chemotherapy have been conducted.
Slovenian: Izvedenih je bilo le nekaj študij o medsebojnem delovanju mifamurtida s kemoterapijo.
English: If you have long-lasting or worsening symptoms, you should contact your doctor, as MEPACT treatment may need to be delayed or discontinued.
Slovenian: Če imate dolgotrajne simptome ali simptome, ki se slabšajo, o tem obvestite zdravnika, saj bo zdravljenje z zdravilom MEPACT morda treba preložiti ali prekiniti.
English: If not used immediately, the reconstituted, filtered and diluted solution in-use storage times and conditions prior to use of the reconstituted product must not be longer than 6 hours at 25 ºC.
Slovenian: Če ni uporabljeno takoj, čas shranjevanja rekonstituirane, filtrirane in razredčene, za uporabo pripravljene suspenzije pred uporabo rekonstituiranega zdravila ne sme preseči 6 ur pri temperaturi 25 °C.
English: Major toxic effects associated with these high daily and cumulative doses of mifamurtide were mainly exaggerated pharmacological effects: pyrexia, signs of pronounced inflammatory response manifested as synovitis, bronchopneumonia, pericarditis and inflammatory necrosis of the liver and bone marrow.
Slovenian: Glavni toksični učinki, povezani s temi visokimi dnevnimi odmerki in kumulativnimi odmerki mifamurtida, so bili predvsem poudarjeni farmakološki učinki: pireksija, znaki izrazitega vnetnega odziva v obliki sinovitisa, bronhopnevmonije, perikarditisa in vnetne nekroze jeter in kostnega mozga.
English: There was no effect of mild hepatic impairment on the systemic exposure (AUCinf) of total MTP-PE.
Slovenian: Blaga okvara jeter ni imela nobenega vpliva na sistemsko izpostavljenost (AUCinf) skupnemu MTP-PE.
English: Occasional allergic reactions have been associated with mifamurtide treatment, including rash, shortness of breath and grade 4 hypertension (see section 4.8).
Slovenian: Zdravljenje z mifamurtidom je bilo občasno povezano s pojavom alergijskih reakcij, vključno z izpuščajem, zasoplostjo in hipertenzijo 4. stopnje (glejte poglavje 4.8).
English: One patient in the phase III study experienced 2 episodes of grade 4 seizure while on study therapy with chemotherapy and mifamurtide.
Slovenian: Pri enem bolniku v študiji III. faze sta pri zdravljenju s kemoterapijo in z mifamurtidom pojavila 2 epizodi epileptičnih napadov 4. stopnje.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na enoto odmerka, kar v bistvu pomeni "brez natrija".
English: Dizziness, vertigo, fatigue and blurred vision have shown as very common or common undesirable effects of mifamurtide treatment.
Slovenian: Izkazalo se je, da so omotica, vrtoglavica, utrujenost in zamegljen vid zelo pogosti ali pogosti neželeni učinki mifamurtida.
English: • 1 Filter for MEPACT
Slovenian: • 1 filter za zdravilo MEPACT
English: It is recommended that the reconstitution of the liposomal suspension should be performed in a laminar flow cabinet utilising sterile gloves using aseptic technique.
Slovenian: Priporočljivo je, da rekonstitucijo liposomske suspenzije opravite v komori z laminarnim pretokom zraka z uporabo sterilnih rokavic in z aseptično tehniko.
English: The recommended dose of MEPACT is 2 mg mifamurtide/m body surface area.
Slovenian: Priporočeni odmerek zdravila MEPACT je 2 mg mifamurtida/m2 telesne površine.
English: • Sodium chloride 9 mg/mL (0.9%) solution for injection, 100 mL bag
Slovenian: • raztopina natrijevega klorida 9 mg/ml (0,9%) za injiciranje, 100 ml vrečka
English: Moderate hepatic impairment resulted in a small increase in AUCinf of total MTP-PE, with the geometric least square mean ratio (expressed as %) for moderate hepatic impairment in reference to the matched normal hepatic function group being 119% (90% confidence interval [CI]: 94.1%-151%).
Slovenian: Zmerna okvara jeter je povzročila majhno povečanje AUCinf skupnemu MTP-PE, pri čemer je razmerje geometrijskih srednjih vrednosti najmanjših kvadratov (izraženo v%) pri zmerni okvari jeter v primerjavi s primerljivo skupino z normalnim delovanjem jeter znašalo 119% (90% interval zaupanja [IZ]: 94,1%-151%).
English: Association of mifamurtide with signs of pronounced inflammatory response, including pericarditis and pleuritis, was uncommon.
Slovenian: Mifamurtid je bil občasno povezan z znaki poudarjenega vnetnega odziva, vključno s perikarditisom in plevritisom.
English: Episodes of neutropenic fever should be monitored and managed appropriately.
Slovenian: Epizode nevtropenije z zvišano telesno temperaturo je treba nadzirati in ustrezno zdraviti.
English: There was also one report of a grade 4 allergic reaction (hypertension) requiring hospitalization in the phase III study (see section 4.4).
Slovenian: Tudi v študiji III. faze so poročali o enem primeru alergijske reakcije 4. stopnje (hipertenzija), zaradi katere je bilo treba bolnika sprejeti in zdraviti v bolnišnici (glejte poglavje 4.4).
English: In a large controlled randomised study, mifamurtide used at the recommended dose and schedule with other medicinal products that have known renal (cisplatin, ifosfamide) or hepatic (high-dose methotrexate, ifosfamide) toxicities did not exacerbate those toxicities and there was no need to adjust mifamurtide dose.
Slovenian: V obsežni nadzorovani randomizirani študiji se pri uporabi mifamurtida v priporočenem odmerku in režimu odmerjanja skupaj z drugimi zdravili, za katera je znano, da so toksična za ledvice (cisplatin, ifosfamid) ali jetra (visok odmerek metotreksata, ifosfamid), toksičnost ni povečala, odmerka mifamurtida pa ni bilo treba prilagajati.
English: - if you are taking medicines containing ciclosporin or other calcineurin inhibitors or high doses of non-steroidal-anti-inflammatory drugs (NSAIDs) (see “Using other medicines” below).
Slovenian: - če jemljete zdravila, ki vsebujejo ciklosporin ali druge zaviralce kalcinevrina ali velike odmerke nesteroidnih protivnetnih zdravil (glejte “Druga zdravila in zdravilo MEPACT” v nadaljevanju).
English: In 21 healthy adult subjects mifamurtide was cleared rapidly from serum (minutes) with a half-life of 2.05 ± 0.40 hours, resulting in a very low serum concentration of total (liposomal and free) mifamurtide.
Slovenian: Pri 21 zdravih odraslih preiskovancih se je mifamurtid hitro očistil iz seruma (minute) z razpolovnim časom 2,05 ± 0,40 ure, zato je bila koncentracija skupnega mifamurtida (liposomskega in prostega) v serumu zelo nizka.
English: Mifamurtide is, therefore, not expected to interact with the metabolism of substances that are hepatic cytochrome P450 substrates.
Slovenian: Zato se ne pričakuje, da bi mifamurtid vplival na presnovo snovi, ki so substrati jetrnega citokroma P450.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Slovenian: PRILOGA IV ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: The vial should then be shaken vigorously for 1 minute while keeping the filter and syringe attached.
Slovenian: Vialo nato močno stresajte 1 minuto, pri čemer naj ostaneta filter in brizga pritrjena v njej.
English: Also, it has been demonstrated in vitro that high-dose NSAIDs (cyclooxygenase inhibitors) can block the macrophage activating effect of liposomal mifamurtide.
Slovenian: Poleg tega je bilo in vitro dokazano, da lahko visok odmerek nesteroidnih protivnetnih zdravil (zaviralci ciklooksigenaze) zavre učinek aktivacije makrofagov z liposomskim mifamurtidom.
English: Respiratory disorders, including dyspnoea (21%), cough (18%) and tachypnoea (13%) were very commonly reported, and 2 patients with pre-existing asthma developed mild to moderate respiratory distress associated with MEPACT treatment in a phase II study.
Slovenian: Zelo pogosto so poročali o boleznih dihal, vključno z dispnejo (21%), kašljem (18%) in tahipnejo (13%), pri 2 bolnikih s predhodno astmo pa se je razvila blaga do zmerna dihalna stiska, povezana z zdravljenjem z zdravilom MEPACT v študiji II.
English: Signs and symptoms that were associated with higher doses and/or were dose limiting were not life-threatening, and included fever, chills, fatigue, nausea, vomiting, headache and hypoor hypertension.
Slovenian: Znaki in simptomi, ki so bili povezani z večjimi odmerki in/ali zaradi katerih je bilo treba odmerek zmanjšati, niso bili življenjsko nevarni, vključevali pa so zvišano telesno temperaturo, mrzlico, utrujenost, navzeo, bruhanje, glavobol in hipotenzijo ali hipertenzijo.
English: Based upon the review of the cases, a causal association between mifamurtide and the occurrence of pericardial effusion is considered likely in view of cases with a plausible TTO, absence of other causative factors, and positive dechallenge.
Slovenian: Na podlagi pregleda primerov se smatra, da je vzročna povezanost med mifamurtidom in pojavom perikardialnega izliva verjetna, predvsem na osnovi primerov s skladnim časovnim obdobjem do pojava neželenega učinka, odsotnost drugih vzročnih dejavnikov in izzvenitev neželenega učinka po prenehanju jemanja zdravila (positive dechallenge).
English: These changes were not considered to be clinically meaningful as the maximum tolerated dose (4-6 mg/m2) of mifamurtide is
Slovenian: Te spremembe niso ocenili za klinično pomembne, saj je največji prenosljivi odmerek mifamurtida (4-6 mg/m2) za 2- do 3-krat večji od priporočenega odmerka (2 mg/m2).
English: The cap of the vial should be removed and the stopper cleaned using an alcohol pad.
Slovenian: Z viale odstranite zaporko in zamašek očistite z alkoholno blazinico.
English: BSA-normalised clearance and half-life were similar across the age range and consistent with that determined in healthy adult subjects, supporting the recommended dose of 2 mg/m
Slovenian: Vrednosti na telesno površino prilagojenega očistka in razpolovnega časa so bile pri vseh starostih podobne in konsistentne z vrednostmi pri zdravih odraslih osebah, kar podpira uporabo priporočenega odmerka 2 mg/m2.
English: What MEPACT looks like and contents of the pack MEPACT is a white to off-white homogeneous cake or powder for concentrate for dispersion for infusion.
Slovenian: Izgled zdravila MEPACT in vsebina pakiranja Zdravilo MEPACT je bel ali skoraj bel homogen zbit ali prost prašek za koncentrat za disperzijo za infundiranje.
English: The vial should be allowed to stand undisturbed for 1 minute to ensure thorough hydration of the dry substance.
Slovenian: Vialo pustite stati pri miru 1 minuto, da se prašek temeljito prepoji.
English: Leukopenia, Thrombocytopenia, Granulocytopenia, Febrile neutropenia
Slovenian: Levkopenija, Trombocitopenija, Granulocitopenija, Febrilna nevtropenija
English: Gastrointestinal disorders were frequently associated with mifamurtide administration, including nausea (57%) and vomiting (44%) in about half of patients, constipation (17%), diarrhoea (13%) and abdominal pain (see section 4.4).
Slovenian: Bolezni prebavil so pogosto povezovali z mifamurtidom, vključno z navzeo (57%) in bruhanjem (44%) pri približno polovici bolnikov, zaprtjem (17%), diarejo (13%) in bolečinami v trebuhu (glejte poglavje 4.4).
English: • MEPACT powder for concentrate for dispersion for infusion (vial)
Slovenian: • MEPACT prašek za koncentrat za disperzijo za infundiranje (viala)
English: In the SmPC of mifamurtide, pericarditis is mentioned in section 4.4.
Slovenian: V povzetku glavnih značilnosti zdravila za mifamurtid je v poglavju 4.4 že omenjen perikarditis.
English: There was no effect of mild (50 mL/min ≤ creatinine clearance [CLcr] ≤ 80 mL/min) or moderate (30 mL/min ≤ CLcr < 50 mL/min) renal insufficiency on the clearance of total MTP-PE, when compared with that observed in healthy adult subjects with normal renal function (CLcr > 80 mL/min).
Slovenian: Vpliva blage (50 ml/min ≤ kreatininski očistek [CLcr] ≤ 80 ml/min) ali zmerne (30 ml/min ≤ CLcr < 50 ml/min) ledvične insuficience na očistek skupnega MTP-PE v primerjavi z očistkom pri zdravih odraslih osebah z normalnim delovanjem ledvic (CLcr > 80 ml/min) niso opazili.
English: In vitro interaction studies showed that liposomal and non-liposomal mifamurtide do not inhibit the metabolic activity of cytochrome P450 in pooled human liver microsomes.
Slovenian: In vitro študije medsebojnega delovanja so pokazale, da liposomski in neliposomski mifamurtid ne zavira presnovne aktivnosti citokroma P450 v zbranih humanih jetrnih mikrosomih.
English: • Filter for MEPACT
Slovenian: • filter za zdravilo MEPACT
English: In a randomised controlled study, the incidence of myeloid malignancy (acute myeloid leukaemia/myelodysplastic syndrome) was the same in patients receiving MEPACT plus chemotherapy as in patients receiving only chemotherapy (2.1%).
Slovenian: V randomizirani nadzorovani študiji je bila pojavnost mieloidnih novotvorb (akutna mieloična levkemija/mielodisplastični sindrom) pri bolnikih, ki so se zdravili z zdravilom MEPACT in s kemoterapijo, enaka kot pri bolnikih, ki so se zdravili samo s kemoterapijo (2,1%).
English: Based on the liposomal nature of the product, use of an infusion set with an in-line filter during administration is not recommended.
Slovenian: Zaradi liposomskih značilnosti izdelka med dajanjem zdravila ni priporočljiva uporaba infuzijskega sistema z linijskim filtrom.
English: Mifamurtide is not recommended for use during pregnancy and in women of childbearing potential not using effective contraception.
Slovenian: Mifamurtida ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Very common side effects (may affect more than 1 in 10 people): - fever, shaking/shivering, weakness, tiredness or general discomfort - nausea and/or vomiting, diarrhoea or constipation - headache or dizziness - rapid beating of the heart - high blood pressure or low blood pressure - no appetite for food - sweating - pain, including general pain, pain in your muscles and/or joints and pain in back, chest,
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - zvišana telesna temperatura, tresenje/drgetanje, oslabelost, utrujenost ali splošno slabo počutje - siljenje na bruhanje in/ali bruhanje, driska ali zaprtost - glavobol ali omotica - hitro bitje srca - visok krvni tlak ali nizek krvni tlak - pomanjkanje apetita - znojenje - bolečina, vključno s splošno bolečino, bolečino v mišicah in/ali sklepih in bolečino v hrbtu,
English: The pharmacokinetics of mifamurtide have been characterised in healthy adult subjects following a 4 mg intravenous infusion and in paediatric and adult patients with osteosarcoma following a 2 mg/m intravenous infusion.
Slovenian: Farmakokinetiko mifamurtida so pri zdravih odraslih osebah vrednotili po intravenskem infundiranju 4-mg odmerka, pri pediatričnih in odraslih bolnikih z osteosarkomom pa po intravenskem infundiranju odmerka 2 mg/m2.
English: Mifamurtide treatment was continued for the remainder of the study without seizure recurrence.
Slovenian: V preostanku študije se je zdravljenje z mifamurtidom nato nadaljevalo brez ponovitve epileptičnega napada.
English: Paraesthesia, Hypoaesthesia, Tremor, Somnolence, Lethargy
Slovenian: Parestezija, Hipestezija, Tremor, Somnolenca, Letargija
English: An osteosarcoma patient in a phase II study who had high creatinine level at enrolment showed an increase in blood urea and blood creatinine which was associated with mifamurtide use.
Slovenian: faze so pri bolniku z osteosarkomom, ki je imel ob vključitvi visoko vrednost kreatinina, poročali o zvišanih vrednostih sečnine v krvi in kreatinina v krvi, ki so bile povezane z uporabo mifamurtida.
English: Confusional state, Depression, Insomnia, Anxiety
Slovenian: Zmedenost, Depresija, Nespečnost, Anksioznost
English: Concurrent use with ciclosporin or other calcineurin inhibitors (see section 4.5).
Slovenian: Sočasna uporaba s ciklosporinom ali z drugimi zaviralci kalcinevrina (glejte poglavje 4.5).