natgillin/translations-raw huggingface dataset:
If you have long-lasting or worsening symptoms, you should contact your doctor, as MEPACT treatment may need to be delayed or discontinued.
Če imate dolgotrajne simptome ali simptome, ki se slabšajo, o tem obvestite zdravnika, saj bo zdravljenje z zdravilom MEPACT morda treba preložiti ali prekiniti.
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.
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.
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.
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.
There was no effect of mild hepatic impairment on the systemic exposure (AUCinf) of total MTP-PE.
Blaga okvara jeter ni imela nobenega vpliva na sistemsko izpostavljenost (AUCinf) skupnemu MTP-PE.
Occasional allergic reactions have been associated with mifamurtide treatment, including rash, shortness of breath and grade 4 hypertension (see section 4.8).
Zdravljenje z mifamurtidom je bilo občasno povezano s pojavom alergijskih reakcij, vključno z izpuščajem, zasoplostjo in hipertenzijo 4. stopnje (glejte poglavje 4.8).
One patient in the phase III study experienced 2 episodes of grade 4 seizure while on study therapy with chemotherapy and mifamurtide.
Pri enem bolniku v študiji III. faze sta pri zdravljenju s kemoterapijo in z mifamurtidom pojavila 2 epizodi epileptičnih napadov 4. stopnje.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na enoto odmerka, kar v bistvu pomeni "brez natrija".
Dizziness, vertigo, fatigue and blurred vision have shown as very common or common undesirable effects of mifamurtide treatment.
Izkazalo se je, da so omotica, vrtoglavica, utrujenost in zamegljen vid zelo pogosti ali pogosti neželeni učinki mifamurtida.
• 1 Filter for MEPACT
• 1 filter za zdravilo MEPACT
It is recommended that the reconstitution of the liposomal suspension should be performed in a laminar flow cabinet utilising sterile gloves using aseptic technique.
Priporočljivo je, da rekonstitucijo liposomske suspenzije opravite v komori z laminarnim pretokom zraka z uporabo sterilnih rokavic in z aseptično tehniko.
The recommended dose of MEPACT is 2 mg mifamurtide/m body surface area.
Priporočeni odmerek zdravila MEPACT je 2 mg mifamurtida/m2 telesne površine.
• Sodium chloride 9 mg/mL (0.9%) solution for injection, 100 mL bag
• raztopina natrijevega klorida 9 mg/ml (0,9%) za injiciranje, 100 ml vrečka
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%).
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%).
Association of mifamurtide with signs of pronounced inflammatory response, including pericarditis and pleuritis, was uncommon.
Mifamurtid je bil občasno povezan z znaki poudarjenega vnetnega odziva, vključno s perikarditisom in plevritisom.
Episodes of neutropenic fever should be monitored and managed appropriately.
Epizode nevtropenije z zvišano telesno temperaturo je treba nadzirati in ustrezno zdraviti.
There was also one report of a grade 4 allergic reaction (hypertension) requiring hospitalization in the phase III study (see section 4.4).
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).
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.
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.
- 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).
- če jemljete zdravila, ki vsebujejo ciklosporin ali druge zaviralce kalcinevrina ali velike odmerke nesteroidnih protivnetnih zdravil (glejte “Druga zdravila in zdravilo MEPACT” v nadaljevanju).
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.
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.
Mifamurtide is, therefore, not expected to interact with the metabolism of substances that are hepatic cytochrome P450 substrates.
Zato se ne pričakuje, da bi mifamurtid vplival na presnovo snovi, ki so substrati jetrnega citokroma P450.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
PRILOGA IV ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
The vial should then be shaken vigorously for 1 minute while keeping the filter and syringe attached.
Vialo nato močno stresajte 1 minuto, pri čemer naj ostaneta filter in brizga pritrjena v njej.
Also, it has been demonstrated in vitro that high-dose NSAIDs (cyclooxygenase inhibitors) can block the macrophage activating effect of liposomal mifamurtide.
Poleg tega je bilo in vitro dokazano, da lahko visok odmerek nesteroidnih protivnetnih zdravil (zaviralci ciklooksigenaze) zavre učinek aktivacije makrofagov z liposomskim mifamurtidom.
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.
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.
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.
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.
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.
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).
These changes were not considered to be clinically meaningful as the maximum tolerated dose (4-6 mg/m2) of mifamurtide is
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).
The cap of the vial should be removed and the stopper cleaned using an alcohol pad.
Z viale odstranite zaporko in zamašek očistite z alkoholno blazinico.
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
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.
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.
Izgled zdravila MEPACT in vsebina pakiranja Zdravilo MEPACT je bel ali skoraj bel homogen zbit ali prost prašek za koncentrat za disperzijo za infundiranje.
The vial should be allowed to stand undisturbed for 1 minute to ensure thorough hydration of the dry substance.
Vialo pustite stati pri miru 1 minuto, da se prašek temeljito prepoji.
Leukopenia, Thrombocytopenia, Granulocytopenia, Febrile neutropenia
Levkopenija, Trombocitopenija, Granulocitopenija, Febrilna nevtropenija
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).
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).
• MEPACT powder for concentrate for dispersion for infusion (vial)
• MEPACT prašek za koncentrat za disperzijo za infundiranje (viala)
In the SmPC of mifamurtide, pericarditis is mentioned in section 4.4.
V povzetku glavnih značilnosti zdravila za mifamurtid je v poglavju 4.4 že omenjen perikarditis.
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).
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.
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.
In vitro študije medsebojnega delovanja so pokazale, da liposomski in neliposomski mifamurtid ne zavira presnovne aktivnosti citokroma P450 v zbranih humanih jetrnih mikrosomih.
• Filter for MEPACT
• filter za zdravilo MEPACT
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%).
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%).
Based on the liposomal nature of the product, use of an infusion set with an in-line filter during administration is not recommended.
Zaradi liposomskih značilnosti izdelka med dajanjem zdravila ni priporočljiva uporaba infuzijskega sistema z linijskim filtrom.
Mifamurtide is not recommended for use during pregnancy and in women of childbearing potential not using effective contraception.
Mifamurtida ni priporočljivo uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
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,
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,
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.
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.
Mifamurtide treatment was continued for the remainder of the study without seizure recurrence.
V preostanku študije se je zdravljenje z mifamurtidom nato nadaljevalo brez ponovitve epileptičnega napada.
Paraesthesia, Hypoaesthesia, Tremor, Somnolence, Lethargy
Parestezija, Hipestezija, Tremor, Somnolenca, Letargija
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.
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.
Confusional state, Depression, Insomnia, Anxiety
Zmedenost, Depresija, Nespečnost, Anksioznost
Concurrent use with ciclosporin or other calcineurin inhibitors (see section 4.5).
Sočasna uporaba s ciklosporinom ali z drugimi zaviralci kalcinevrina (glejte poglavje 4.5).
If your problems increase, you should contact your doctor, as these may have been caused by MEPACT when used with chemotherapy.
Če se težave slabšajo, se posvetujte z zdravnikom, saj bi lahko bile posledica uporabe zdravila MEPACT v kombinaciji s kemoterapijo.
No dedicated fertility studies have been conducted with mifamurtide (see section 5.3).
Posebnih študij o vplivu mifamurtida na plodnost niso izvedli (glejte poglavje 5.3).
Some very common and common side effects of MEPACT treatment (such as dizziness, vertigo, fatigue and blurred vision) may affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri zelo pogosti in pogosti neželeni učinki zdravljenja z zdravilom MEPACT (kot so omotica, vrtoglavica, utrujenost in zamegljen vid) lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
MEPACT is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection.
Zdravilo MEPACT je indicirano za zdravljenje operabilnega nerazsejanega osteosarkoma visoke stopnje pri otrocih, mladostnikih in mladih odraslih po popolni makroskopski kirurški odstranitvi.
Taking into account the PRAC Assessment Report on the PSUR(s) for mifamurtide, the scientific conclusions of the CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za mifamurtid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
• 2 medium (18) gauge sterile injection needles
• 2 sterilni injekcijski igli srednje dimenzije (18)
Unopened vial of powder
Zaprta viala s praškom
For intravenous use after reconstitution, filtering using the filter provided and further dilution.
Za intravensko uporabo po rekonstituciji, filtriranju s priloženim filtrom in nadaljnjem redčenju.
Oedema, chest discomfort, local infusion or catheter site reactions and ‘feeling cold' were less frequently reported in these patients, mostly with late stage malignant disease.
Pri teh bolnikih so redkeje poročali o edemu, nelagodju v prsnem košu, lokalnih reakcijah na mestu aplikacije ali katetra ter “občutku mraza”, večinoma pri bolnikih z maligno boleznijo v poznem stadiju.
if you have stomach problems such as nausea, vomiting and lack of appetite.
- če imate prebavne težave, kot so siljenje na bruhanje, bruhanje in izguba apetita.
If you have worsening symptoms, you should contact your doctor, as these may have been caused by MEPACT.
V primeru simptomov, ki se slabšajo, se posvetujte z zdravnikom, saj bi le-ti lahko bili posledica zdravila MEPACT.
Each vial contains 4 mg of mifamurtide.
Ena viala vsebuje 4 mg mifamurtida.
Other generalised symptoms that were typically mild to moderate and very common included hypothermia (23%), malaise (13%), pain (15%), asthenia (13%) and chest pain (11%).
Ostali generalizirani simptomi, ki so bili tipično blagi do zmerni in zelo pogosti, so hipotermija (23%), splošno slabo počutje (13%), bolečina (15%), astenija (13%) in bolečina v prsih (11%).
50 mL type I glass vial with a grey butyl rubber stopper, aluminium seal and plastic flip-off cap, containing 4 mg of mifamurtide.
50-mililitrska viala iz stekla tipa I, zaprta z zamaškom iz sive butilne gume, aluminijastim obročkom in dvižno plastično zaporko, ki vsebuje 4 mg mifamurtida.
Mean half-lives of total and free MTP-PE in mild hepatic impairment were 2.02 hours and 1.99 hours, respectively, and were comparable to those in subjects with normal hepatic function (2.15 hours and 2.26 hours, respectively).
Pri blagi okvari jeter je bil srednji razpolovni čas skupnega MTP-PE 2,02 ure, prostega MTP-PE pa 1,99 ure, kar je primerljivo z vrednostmi pri osebah z normalnim delovanjem jeter (2,15 ure oziroma 2,26 ure).
Continued monitoring of the kidney and liver function is recommended if mifamurtide is used beyond completion of chemotherapy until all therapy is completed.
Če se mifamurtid uporablja po zaključku kemoterapije, se priporoča neprekinjeno spremljanje ledvične in jetrne funkcije, dokler ni celotno zdravljenje zaključeno.
The volume of reconstituted suspension corresponding to the calculated dose is extracted through the filter provided and further diluted with additional 50 mL sodium chloride 9 mg/mL (0.9%) solution for injection according to the detailed instructions shown below.
Volumen rekonstituirane suspenzije, ki ustreza izračunanemu odmerku, se izvleče skozi priloženi filter in nato razredči z dodatnimi 50 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje v skladu s podrobnimi navodili, ki so navedena spodaj.
Consistent with other generalised symptoms, the very common nervous system disorders were headache (50%) and dizziness (17%).
V skladu z ostalimi generaliziranimi simptomi sta bili zelo pogosti bolezni živčevja glavobol (50%) in omotica (17%).
Vertigo, Tinnitus, Hearing loss
Vrtoglavica, Tinitus, Izguba sluha
Anaemia has very commonly been reported when mifamurtide is used in conjunction with chemotherapeutic agents.
O anemiji so zelo pogosto poročali pri uporabi mifamurtida skupaj s kemoterapevtskimi zdravili.
Administration of mifamurtide was commonly associated with transient neutropenia, usually when used in conjunction with chemotherapy.
Uporaba mifamurtida je bila pogosto povezana s prehodno nevtropenijo, ponavadi ko se je zdravilo uporabljalo v kombinaciji s kemoterapijo.
Additionally, the geometric mean plasma AUCinf of free (non-liposome associated) MTP-PE in mild and moderate hepatic impairment were 47% higher than the corresponding values in the matched normal hepatic function groups.
Razen tega pa je bila pri blagi in zmerni okvari jeter geometrijska srednja vrednost AUCinf prostega (nevezanega na liposome) MTP-PE v plazmi za 47% večja od ustreznih vrednosti pri primerljivih skupinah z normalnim delovanjem jeter.
There are no clinically meaningful effects of mild to moderate renal (creatinine clearance (CrCL) ≥ 30 mL/min) or hepatic impairment (Child-Pugh class A or B) on the pharmacokinetics of mifamurtide; therefore, dose adjustments are not necessary for these patients.
Blaga do zmerna okvara ledvic (kreatininski očistek (CrCL) ≥ 30 ml/min) ali jeter (Child-Pugh razred A ali B) nimata klinično pomembnih učinkov na farmakokinetiko mifamurtida, zato pri teh bolnikih odmerka ni treba prilagajati.
Musculoskeletal and connective tissue disorders Low grade pain was very common in patients receiving mifamurtide, including myalgia (31%), back pain (15%), extremity pain (12%) and arthralgia (10%).
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pri bolnikih, ki so prejemali mifamurtid, je bila zelo pogosta blaga bolečina, vključno z mialgijo (31%), bolečino v hrbtu (15%), bolečino v okončinah (12%) in artralgijo (10%).
Concurrent use with high-dose non-steroidal-anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors) (see section 4.5).
Sočasna uporaba z visokim odmerkom nesteroidnih protivnetnih zdravil (NSAIDs, zaviralci ciklooksigenaze) (glejte poglavje 4.5).
Sepsis, Cellulitis, Nasopharyngitis, Catheter site infection, Upper respiratory tract infection, Urinary tract infection, Pharyngitis, Herpes simplex infection
Sepsa, Celulitis, Nazofaringitis, Okužba na mestu vstavljenega katetra, Okužba zgornjih dihal, Okužba sečil, Faringitis, Okužba s Herpes simplex
Patients with a history of venous thrombosis, vasculitis or unstable cardiovascular disorders should be closely monitored during mifamurtide administration.
Bolnike z vensko trombozo, vaskulitisom ali nestabilnimi srčno-žilnimi boleznimi v anamnezi je treba med uporabo mifamurtida skrbno nadzirati.
if you have a history of asthma or other breathing disorders.
- če imate ali ste kdaj imeli astmo ali druga obolenja dihal.
What MEPACT contains - The active substance is mifamurtide.
Kaj vsebuje zdravilo MEPACT - Zdravilna učinkovina je mifamurtid.
Rash, Pruritis, Erythema, Alopecia, Dry skin
Izpuščaj, Srbenje, Rdečina, Alopecija, Suha koža
In addition, pericardial effusion is a listed ADR for another immunostimulant, i.e. aldesleukin.
Poleg tega je perikardialni izliv naveden kot neželeni učinek tudi pri drugem imunostimulantu, tj. aldeslevkin.
The bag injection site should be wiped with an alcohol pad and the suspension in the syringe should be injected into the original bag containing the remaining 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (figure 4).
Mesto, kjer boste prebodli vrečko, morate obrisati z alkoholno blazinico, suspenzijo v brizgi pa injicirajte v originalno vrečko, ki vsebuje preostalih 50 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje (slika 4).
Additionally, the systemic exposures AUC from zero to infinity (AUCinf of free (non-liposome associated) MTP-PE in mild or moderate renal insufficiency were similar to those observed in healthy adult subjects with normal renal function.
Tudi sistemska izpostavljenost za AUC od nič do neskončnosti (AUCinf) prostemu (nevezanemu na liposome) MTP-PE je bila pri odraslih prostovoljcih z blago ali zmerno ledvično insuficienco podobna kot pri zdravih odraslih osebah z normalnim delovanjem ledvic.
The spike should then be inserted into the vial septum firmly until seated.
Konico nato trdno potisnite v septum viale, dokler ni nameščena.