natgillin/translations-raw huggingface dataset:
The population PK of siltuximab were analysed to evaluate the effects of demographic characteristics.
Populacijska farmakokinetika siltuksimaba bila je analizirana radi procjene učinaka demografskih karakteristika.
• you have a condition such as stomach ulcer or diverticulitis that may increase the risk of getting a tear in the stomach or gut (gastrointestinal perforation).
• ako imate stanje kao što je čir na želucu ili divertikulitis, koje može povećati rizik za nastajanje pukotine na želucu ili crijevima (perforacija probavnog sustava).
IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation.
Pokazalo se da je IL-6 uključen u različite normalne fiziološke procese kao što je indukcija sekrecije imunoglobulina, inicijacija sinteze jetrenih proteina akutne faze i stimulacija proliferacije i diferencijacije hematopoetske prekursorske stanice.
Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6).
Kemijska i fizikalna stabilnost tijekom primjene bila je dokazana do 8 sati pri sobnoj temperaturi
Binding bioactive IL-6 by siltuximab may result in increased metabolism of CYP450 substrates, because CYP450 enzyme activity will normalise.
Vezanje bioaktivnog IL-6 sa siltuksimabom može dovesti do povećanog metabolizma supstrata CYP450, jer će se aktivnost enzima CYP450 normalizirati.
Following the first administration of siltuximab (doses ranging from 0.9 to 15 mg/kg), the area under the concentration-time curve (AUC) and maximal serum concentration (Cmax) increased in a dose-proportional manner and clearance (CL) was independent of dose.
Nakon prve primjene siltuksimaba (doze u rasponu od 0,9 do 15 mg/kg), površina ispod krivulje koncentracija-vrijeme (AUC) i maksimalna koncentracija u serumu (Cmax) povisili su se proporcionalno s dozom, a klirens (CL) je bio neovisan o dozi.
Alternatively PE bottles may be used.
Kao alternativa, smiju se koristiti boce od polietilena.
Upon resolution of the reaction, reinitiating the infusion at a lower infusion rate and therapeutic administration of antihistamines, acetaminophen, and corticosteroids may be considered.
Po završetku reakcije, mogu se uzeti u obzir ponovno započinjanje infuzije pri sporijoj brzini infuzije i terapijska primjena antihistaminika, acetaminofena i kortikosteroida.
By binding to IL-6, siltuximab blocks its activity and stops abnormal cell growth.
Vežući se na IL-6, siltuksimab blokira njegovu aktivnost te zaustavlja abnormalan rast stanica.
If the patient develops a severe infusion related reaction, anaphylaxis, severe allergic reaction, or cytokine release syndrome related to the infusion, further administration of SYLVANT should be discontinued.
Ukoliko bolesnik razvije tešku reakciju povezanu s infuzijom, anafilaksiju, tešku alergijsku reakciju ili sindrom otpuštanja citokina koji je povezan s infuzijom, mora se prekinuti daljnja primjena lijeka SYLVANT.
The infusion should be completed within 6 hours of the addition of the reconstituted solution to the infusion bag.
Infuzija mora završiti unutar 6 sati od dodavanja rekonstituirane otopine u infuzijsku vrećicu.
Studies in animals with siltuximab have shown no adverse effect on pregnancy or on embryofetal development (see section 5.3).
Ispitivanja na životinjama sa siltuksimabom nisu pokazala nuspojave vezane za trudnoću ili embriofetalni razvoj (vidjeti dio 5.3).
Available non-clinical data do not suggest an effect on fertility under siltuximab treatment (see section 5.3).
Dostupni neklinički podaci ne ukazuju na učinak na plodnost tijekom liječenja siltuksimabom (vidjeti dio 5.3).
No major age-related differences in pharmacokinetics (PK) or in safety profile were observed in clinical studies.
U kliničkim ispitivanjima nisu opažene veće razlike u farmakokinetici (PK) ili sigurnosnom profilu povezane s dobi.
This medicinal product is for single use only.
Ovaj lijek je namijenjen samo za jednokratnu primjenu.
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
For patients who do not tolerate the infusion following these interventions, SYLVANT should be discontinued.
Za bolesnike koji ne podnose infuziju nakon tih postupaka, primjenu lijeka SYLVANT mora se prekinuti.
Siltuximab (9.2 and 46 mg/kg/week) did not produce any toxicity of the reproductive tract in cynomolgus monkeys.
Siltuksimab (9,2 i 46 mg/kg/tjedan) nije prouzrokovao nikakvu toksičnost na reproduktivnom sustavu cynomolgus majmuna.
Symptoms of this disease may include feeling tired, sweating at night, having a tingling feeling, and loss of appetite.
Simptomi ove bolesti mogu uključivati osjećaj umora, noćno znojenje, osjećaj trnaca i gubitak teka.
Overproduction of IL-6, in chronic inflammatory diseases and malignancies has been linked to anaemia and cachexia and has been hypothesised to play a central role in driving plasma cell proliferation and systemic manifestations in patients with CD.
Prekomjerna proizvodnja IL-6, u kroničnim upalnim bolestima i u zloćudnim bolestima bila je povezana s anemijom i kaheksijom, te je postavljena hipoteza da ima glavnu ulogu u upravljanju proliferacijom plazma stanica i sistemskim manifestacijama u bolesnika s CD.
First tabulated update:
Prvi tablični prikaz:
Therefore, administering siltuximab with CYP450 substrates that have a narrow therapeutic index has the potential to change therapeutic effects and toxicity of these medicinal products due to alteration in the CYP450 pathways.
Stoga, primjena siltuksimaba sa supstratima CYP450 koji imaju uski terapijski indeks ima potencijal promjene terapijskih učinaka i toksičnosti tih lijekova zbog promjene CYP450 puteva.
Siltuximab crossed the placenta during gestation whereby fetal serum concentrations of siltuximab at gestation day (GD) 140 were similar to maternal concentrations.
Siltuksimab je prolazio posteljicu tijekom gestacije čime su koncentracije serumskog siltuksimaba na 140. gestacijski dan u fetusu bile slične maternalnim koncentracijama.
Infections (including upper respiratory tract infections), pruritus, rash, arthralgia, and diarrhoea were the most common adverse reactions , occurring in > 20% of siltuximab-treated patients in Castleman's disease (CD) clinical studies.
Infekcije (uključujući infekcije gornjeg dišnog sustava), pruritus, osip, artralgija i proljev bile su najčešće nuspojave, pojavljujući se u > 20% bolesnika liječenih siltuksimabom u kliničkim ispitivanjima Castlemanove bolesti (CD, engl.
Multicentric Castleman's disease causes benign tumours (non-cancerous growths) to develop in the lymph nodes in the body.
Multicentrična Castlemanova bolest uzrokuje dobroćudne tumore (nekancerozne izrasline) u limfnim čvorovima u tijelu.
Evidence from studies conducted with siltuximab and other IL-6 inhibitors suggest that the potential for siltuximab to cause carcinogenicity is low.
Dokazi iz ispitivanja provedenih sa siltuksimabom i drugim IL-6 inhibitorima ukazuju na nizak potencijal siltuksimaba za razvoj kancerogenosti.
Siltuximab treatment in MCD results in rapid and sustained decreases in CRP serum concentrations.
Liječenjem MCD-a siltuksimabom dolazi do brzog i trajnog pada koncentracija CRP-a u serumu.
A total of 79 patients with symptomatic MCD were randomised and treated.
Ukupno je randomizirano i liječeno 79 bolesnika sa simptomatskom MCD.
Live, attentuated vaccines should not be given concurrently or within 4 weeks before initiating SYLVANT as clinical safety has not been established.
Živa oslabljena cjepiva ne smiju se primjenjivati istovremeno ili unutar 4 tjedna prije početka liječenja lijekom SYLVANT, jer klinička sigurnost nije ustanovljena.
Infusion bags (250 mL) must contain dextrose 5% and must be made of polyvinyl chloride (PVC), or polyolefin (PO), or polypropylene (PP), or polyethylene (PE).
Infuzijske vrećice (250 ml) moraju sadržavati 5%-tnu dekstrozu i moraju biti napravljene od polivinilklorida (PVC), poliolefina (PO), polipropilena (PP) ili polietilena (PE).
Hypoglobulinaemia was observed in 4 to 11.3% of patients in the clinical study.
U kliničkom ispitivanju, hipoglobulinemija je opažena u 4 do 11,3% bolesnika.
The incidence rate of detectable anti-siltuximab antibodies was 0.9% (4/432) overall and 2.1% (4/189) in patients with at least once sample tested with the high medicinal product tolerant ECLIA assay.
Stopa incidencije detektabilnih anti-siltuksimab protutijela bila je ukupno 0,9% (4/432) i 2,1% (4/189) u bolesnika s barem jednim uzorkom ispitanim ECLIA pretragom koja je visoko tolerantna na lijek.
• high fat levels in your blood (hypertriglyceridaemia)
• visoke razine masnoća u krvi (hipertrigliceridemija)
Prescribers should also exercise caution when siltuximab is co-administered with medicinal products that are CYP3A4 substrates where a decrease in effectiveness would be undesirable (e.g., oral contraceptives).
Liječnici koji propisuju lijek također bi trebali biti oprezni kada se siltuksimab primjenjuje istovremeno s lijekovima supstratima CYP3A4 čije smanjenje učinkovitosti ne bi bilo poželjno (npr.
SYLVANT is used to treat multicentric Castleman's disease (MCD) in adult patients who do not have human immunodeficiency virus (HIV) or human herpesvirus-8 (HHV-8) infection.
SYLVANT se koristi za liječenje multicentrične Castlemanove bolesti (MCD, engl. multicentric Castleman's disease) u odraslih bolesnika koji nemaju infekciju virusom humane imunodeficijencije (HIV) ili humanim herpes virusom-8 (HHV-8).
In clinical studies, siltuximab was associated with an infusion related reaction or hypersensitivity reaction in 5.1% (severe reaction in 0.8%) of patients treated with siltuximab monotherapy.
U kliničkim ispitivanjima, siltuksimab je bio povezan s reakcijama povezanim s infuzijom ili reakcijama preosjetljivosti u 5,1% (teška reakcija u 0,8%) bolesnika liječenih siltuksimabom u monoterapiji.
Do not use if you see opaque or foreign particles and/or if the solution appears discoloured after reconstitution.
Nemojte koristiti ako uočite neprozirne ili strane čestice i/ili ako otopina nakon rekonstitucije promijeni boju.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you are given SYLVANT.
Ukoliko se bilo što od gore navedenog odnosi na Vas (ili ako niste sigurni), razgovarajte sa svojim liječnikom ili ljekarnikom prije nego primijenite SYLVANT.
An open-label, multicentre, non-randomised Phase 2 study assessed the safety and efficacy of extended treatment with siltuximab in 60 patients with MCD who were previously enrolled in Study 1 (41 patients) or Study 2 (19 patients).
Otvoreno, multicentrično, nerandomizirano ispitivanje faze 2 procijenilo je sigurnost i djelotvornost produženog liječenja siltuksimabom u 60 bolesnika s MCD-om koji su prethodno bili uključeni u Ispitivanje 1 (41 bolesnik) ili Ispitivanje 2 (19 bolesnika).
A consistent treatment effect favouring siltuximab treated patients across all major secondary endpoints was shown in the hyaline vascular subgroup.
Dosljedan učinak liječenja u korist bolesnika liječenih siltuksimabom kroz sve velike sekundarne mjere ishoda pokazao se u podskupini hijalinsko vaskularnog podtipa.
Your doctor may stop your treatment with SYLVANT straight away.
Liječnik Vam može odmah prekinuti liječenje lijekom SYLVANT.
Discontinuing the medicinal product should be considered if there are more than 2 dose delays due to toxicities related to the treatment during the first 48 weeks.
Ukoliko dođe do odgode primjene više od 2 doze zbog toksičnosti povezane s liječenjem tijekom prvih 48 tjedana, mora se razmotriti prekid primjene lijeka.
Administer the diluted solution over a period of 1 hour using administration sets lined with PVC, or polyurethane (PU), or PE, containing a 0.2-micron inline polyethersulfone (PES) filter.
Primijenite razrijeđenu otopinu kroz vremenski period od 1 sat koristeći set za primjenu od PVC-a, poliuretana (PU) ili PE, koji s unutrašnje strane sadrži polietersulfonski (PES) filter od 0,2-mikrona.
During an embryo-fetal development study where siltuximab was administered intravenously to pregnant cynomolgus monkeys (gestation day 20 - 118) at doses of 9.2 and 46 mg/kg/week, no maternal or fetal toxicity was observed.
Tijekom ispitivanja embrio-fetalnog razvoja, u kojem je siltuksimab bio intravenski primijenjen skotnim cynomolgus majmunima (gestacijski dan 20 - 118) pri dozama od 9,2 i 46 mg/kg/tjedan nije opažena maternalna ili fetalna toksičnost.
a SYLVANT may increase haemoglobin levels in MCD patients
a SYLVANT može povisiti razinu hemoglobina u bolesnika s MCD
Johannes Vermeerplein 11 1071 DV
Johannes Vermeerplein 11
16 patients with MCD treated with 11 mg/kg every 3 weeks, overall tumour response rate by independent review was 43.8% with 6.3% complete response.
U 16 bolesnika s MCD-om koji su liječeni s 11 mg/kg svaka 3 tjedna, ukupna stopa tumorskog odgovora nezavisnom procjenom bila je 43,8% s 6,3% potpunog odgovora.
A slight reduction in T-cell dependent antibody response and a reduction in the size of the splenic germinal centers following Keyhole limpet hemocyanin (KLH) immunisation was observed which were considered to be pharmacological responses of IL-6 inhibition and not of toxicological significance.
Bila je opažena blaga redukcija odgovora protutijela ovisnih o T-stanicama i redukcija veličine zametnih centara slezene nakon cijepljenja Keyhole limpet hemocyanin-om (KLH), što se smatralo farmakološkim odgovorima IL-6 inhibicije, te bez toksikološkog značaja.
Haemoglobin response was defined as a change from baseline of ≥ 15 g/L (0.9 mmol/L) at Week 13.
Odgovor hemoglobina bio je definiran kao promjena od početne vrijednosti od ≥ 15 g/L (0,9 mmol/l) u 13. tjednu.
The repeat-dose toxicology studies conducted in young cynomolgus monkeys at doses of 9.2 and 46 mg/kg/week (up to 22-fold greater exposure than in patients receiving 11 mg/kg every 3 weeks) with siltuximab showed no signs indicative of toxicity.
Ispitivanja toksičnosti ponovljene doze koja su provedena u mladih cynomolgus majmuna pri dozama od 9,2 i 46 mg/kg/tjedan (do 22 puta veća izloženost nego u bolesnika koji primaju 11 mg/kg svaka 3 tjedna) sa siltuksimabom nisu pokazala znakove koji bi upućivali na toksičnost.
The effect of anti-siltuximab antibody status was not examined, as there were insufficient numbers of anti-siltuximab antibody positive patients.
Učinak na status anti-siltuksimab protutijela nije bio ispitan, jer broj bolesnika pozitivnih na anti-siltuksimab protutijela nije bio dovoljan.
Following the repeat dose administration at the recommended dose, siltuximab clearance was found to be time-invariant, and systemic accumulation was moderate (accumulation index of 1.7).
Nakon primjene ponovljene doze pri preporučenoj dozi, otkriveno je da je klirens siltuksimaba neovisan o vremenu, a sistemsko nakupljanje bilo je umjereno (indeks nakupljanja od 1,7).
The most serious adverse reaction associated with the use of siltuximab was anaphylactic reaction.
Najozbiljnija nuspojava povezana s primjenom siltuksimaba bila je anafilaktička reakcija.
The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.
Preporučena doza siltuksimaba je 11 mg/kg primijenjena tijekom 1 sata kao intravenska infuzija koja se primjenjuje svaka 3 tjedna do neuspjeha liječenja.
Measurement of IL-6 concentrations in serum or plasma during treatment should not be used as a pharmacodynamic marker, as siltuximab-neutralised antibody-IL-6 complexes interfere with current immunological-based IL-6 quantification methods.
Mjerenje koncentracija IL-6 u serumu ili plazmi tijekom liječenja ne smije se koristiti kao farmakodinamički marker, jer kompleksi siltuksimab neutralizirajućeg protutijela i IL-6 interferiraju sa sadašnjim metodama kvantifikacije IL-6 koje se temelje na imunološkim metodama.
SYLVANT is a medicine that contains the active substance siltuximab.
SYLVANT je lijek koji sadrži djelatnu tvar siltuksimab.
The primary endpoint of the study was durable tumour and symptomatic response, defined as tumour response assessed by independent review and complete resolution or stabilisation of prospectively collected MCD symptoms, for at least 18 weeks without treatment failure.
Mjera primarnog ishoda ispitivanja bio je trajan tumorski odgovor i simptomatski odgovor, definirano kao tumorski odgovor procijenjen nezavisnom procjenom i potpuni oporavak ili stabilizacija prospektivno prikupljenih simptoma MCD, za najmanje 18 tjedna bez zatajenja liječenja.
Siltuximab is a chimeric (human-murine) immunoglobulin G1κ (IgG1κ) monoclonal antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology.
Siltuksimab je kimerično (ljudsko-mišje) imunoglobulin G1κ (IgG1κ) monoklonsko protutijelo proizvedeno u staničnoj liniji jajnika kineskog hrčka (CHO) tehnologijom rekombinantne DNK.
During intravenous infusion of SYLVANT, mild to moderate infusion reactions may improve following slowing of or stopping the infusion.
Blage do umjerene reakcije na infuziju tijekom intravenske infuzije lijeka SYLVANT mogu se poboljšati nakon usporavanja ili prekida infuzije.
Upon initation or discontinuation of siltuximab in patients being treated with concomitant medicinal products that are CYP450 substrates and have a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or concentration of medicinal product (e.g., cyclosporine or theophylline) is recommended.
Nakon početka ili prestanka primjene siltuksimaba u bolesnika koji se istodobno liječe lijekovima koji su supstrati CYP450 i imaju uzak terapijski indeks, preporučeno je praćenje učinka (npr. varfarin) ili koncentracije lijeka (npr. ciklosporin ili teofilin).
ECOG performance status score (0/1/2) at baseline was 42%/45%/13% in the siltuximab arm and 39%/62%/0% in the placebo arm, respectively.
Rezultat ECOG funkcionalnog stanja (0/1/2) na početku je bio 42%/45%/13% u skupini liječenoj siltuksimabom, odnosno 39%/62%/0% u placebo skupini.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
Elevations in triglycerides and cholesterol (lipid parameters) were observed in patients treated with SYLVANT (see section 4.8).
Povišenja triglicerida i kolesterola (lipidnih parametara) opažena su u bolesnika koji su liječeni lijekom SYLVANT (vidjeti dio 4.8).
Cross-study population PK analyses were performed using data from 378 patients with a variety of conditions who received single-agent siltuximab at doses ranging from 0.9 to 15 mg/kg.
Analize farmakokinetike u križnom populacijskom ispitivanju bile su provedene pomoću podataka za 378 bolesnika s raznovrsnim stanjima, koji su primili samo lijek siltuksimab pri dozama u rasponu od 0,9 do 15 mg/kg.
There are no data from the use of siltuximab in pregnant women.
Nema podataka o primjeni siltuksimaba u trudnica.
You should not stop using SYLVANT without discussing with your doctor first.
Ako prestanete uzimati lijek SYLVANT Ne smijete prestati uzimati lijek SYLVANT bez prethodnog savjetovanja s liječnikom.
No evidence of altered safety or efficacy was identified in the patients who developed antibodies to siltuximab.
Nije dokazana promijenjena sigurnost ili djelotvornost u bolesnika koji su razvili protutijela na siltuksimab.
Patients with MCD produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in lymph nodes.
Bolesnici koji imaju MCD proizvode previše IL-6 i smatra se da to doprinosi poremećenom rastu određenih stanica u limfnim čvorovima.
For patients with baseline alanine transaminase up to 3.7 times the upper limit of normal baseline albumin ranging from 15 to 58 g/L, and baseline bilirubin ranging from 1.7 to 42.8 mg/dL there was no meaningful effect on siltuximab PK.
Za bolesnike s početnom vrijednošću alanin transaminaze do 3,7 puta gornje granice normale, početnom vrijednošću albumina u rasponu od 15 do 58 g/L, i početnom vrijednošću bilirubina u rasponu od 1,7 do 42,8 mg/dL nije bilo značajnog učinka na farmakokinetiku siltuksimaba.
A Phase 2, multinational, randomised (2:1) double-blind, placebo-controlled study was conducted to assess the efficacy and safety of siltuximab (11 mg/kg every 3 weeks) compared with placebo in combination with best supportive care in patients with MCD.
Multinacionalno, randomizirano (2:1) dvostruko slijepo, placebom kontrolirano ispitivanje faze 2, bilo je provedeno radi procjene djelotvornosti i sigurnosti siltuksimaba (11 mg/kg svaka 3 tjedna) u usporedbi s placebom u kombinaciji s najboljom potpornom njegom u bolesnika s MCD.
As with other immunoglobulin G antibodies, siltuximab crosses the placenta as observed in studies in monkeys.
Kao i druga imunoglobulin G protutijela, siltuksimab prolazi kroz posteljicu, što je opaženo u ispitivanjima na majmunima.
Study 2 In addition to Study 1, efficacy data are available in patients with CD from a single arm Phase 1 study
Dodatno uz Ispitivanje 1, podaci o djelotvornosti dostupni su od bolesnika s CD-om iz jedne skupine ispitivanja faze 1 (Ispitivanje 2).
What you need to know before you are given SYLVANT You should not be given SYLVANT if:
Što morate znati prije nego počnete primati SYLVANT Nemojte primati SYLVANT ako:
In Study 1 a statistically significant difference in independently reviewed durable tumour and symptomatic response rate in the siltuximab arm compared with the placebo arm (34% vs. 0%, respectively; 95% CI: 11.1, 54.8; p = 0.0012) was observed.
U Ispitivanju 1 opažena je statistički značajna razlika u nezavisno procijenjenoj stopi trajnog tumorskog odgovora i stopi simptomatskog odgovora u skupini liječenoj siltuksimabom u usporedbi s placebo skupinom (34% naspram 0%; 95% CI: 11,1, 54,8; p = 0,0012).
In long-term treatment of MCD patients with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks, infusion related reactions or hypersensitivity reactions occurred at a frequency of 6.3% (1.3% for severe reactions).
U dugotrajnom ispitivanju sa siltuksimabom u bolesnika s MCD pri preporučenom doziranju od 11 mg/kg svaka 3 tjedna, reakcije povezane s infuzijom ili reakcije preosjetljivosti pojavile su se s učestalošću od 6,3% (1,3% za teške reakcije).
At baseline, 55% of patients in the siltuximab arm and 65% of patients in the placebo arm had received prior systemic therapies for MCD and 30% of patients in the siltuximab arm and 31% in the placebo arm were using corticosteroids.
Na početku je 55% bolesnika u skupini liječenoj siltuksimabom i 65% bolesnika u placebo skupini, primilo prethodne sistemske terapije za MCD i 30% bolesnika u skupini liječenoj siltuksimabom, te
Slowly add the total volume of reconstituted SYLVANT solution to the 250 mL infusion bag.
Polako dodajte ukupni volumen rekonstituirane otopine lijeka SYLVANT u infuzijsku vrećicu od 250 ml.
Select efficacy results from Study 1 in the hyaline vascular subgroup are summarised in Table 4.
Odabrani rezultati djelotvornosti iz Ispitivanja 1 u podskupini hijalinsko vaskularnog podtipa sažeto su prikazani u Tablici 4.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
Inspect the vials for particulate matter and discolouration prior to dose preparation.
Provjerite da bočice ne sadrže čestice i obratite pažnju na promjenu boje prije pripreme doze.