natgillin/translations-raw huggingface dataset:
No new adverse reactions were identified through Week 96 in 2 clinical studies of virologically suppressed patients who switched from emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) to Odefsey (Study GS-US-366-1216) or from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to Odefsey (Study GS-US-366-1160). 
V 2 kliničnih študijah pri bolnikih z virološko supresijo, ki so prešli z emtricitabina/rilpivirina/dizoproksiltenofovirijevega fumarata (FTC/RPV/TDF) na zdravilo Odefsey (študija GS-US-366-1216) ali z efavirenza/emtricitabina/dizoproksiltenofovirijevega fumarata (EFV/FTC/TDF) na zdravilo Odefsey (študija GS-US-366-1160), do konca 96. tedna niso opazili nobenih novih neželenih učinkov.
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 5.2). 
Novih vprašanj glede varnosti pri bolnikih s končno ledvično odpovedjo na kronični hemodializi, ki so dobivali emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov, niso prepoznali (glejte poglavje 5.2).
Each Odefsey tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. 
Ena filmsko obložena tableta zdravila Odefsey vsebuje 200 mg emtricitabina, 25 mg rilpivirina v obliki rilpivirinijevega klorida in 25 mg tenofoviralafenamida v obliki tenofoviralafenamidijevega fumarata.
In the pooled efficacy analysis from the two Phase 3 clinical studies in adults (C209 [ECHO] and C215 [THRIVE]) through 96 weeks, patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure (17.6% with rilpivirine versus 7.6% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL (5.9% with rilpivirine versus 2.4% with efavirenz). 
HIV-1 RNA kopij/ml tveganje za virološki neuspeh (17,6 % z rilpivirinom v primerjavi s 7,6 % z efavirenzom) v primerjavi z bolniki z začetno virusno obremenitvijo ≤ 100.000 HIV-1 RNA kopij/ml (5,9 % z rilpivirinom v primerjavi s 2,4 % z efavirenzom) večje.
-0.3% (95% CI: -4.2% to 3.7%) 
IZ: -4,2 % do 3,7 %)
dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) 
deksametazon (kortikosteroid, ki se uporablja za zdravljenje vnetij in zaviranje imunskega sistema) pri peroralnem jemanju ali injiciran (razen v obliki enkratnega odmerka)
omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acid reflux disease) dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) 
- karbamazepin, okskarbazepin, fenobarbital in fenitoin (zdravila za zdravljenje epilepsije in preprečevanje epileptičnih napadov) - rifabutin, rifampicin in rifapentin (uporablja se za zdravljenje nekaterih bakterijskih okužb, kot je tuberkuloza) - omeprazol, dekslansoprazol, lansoprazol, rabeprazol, pantoprazol in esomeprazol (uporabljajo se za preprečevanje in zdravljenje razjed na želodcu, zgage in refluksne bolezni) - deksametazon (kortikosteroid, ki se uporablja za zdravljenje vnetij in zaviranje imunskega sistema) pri peroralnem jemanju ali injiciran (razen v obliki enkratnega odmerka)
rash1, 3 
izpuščaj1,3
clarithromycin erythromycin These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood. 
Ta zdravila lahko povečajo količino rilpivirina in tenofoviralafenamida (sestavini zdravila Odefsey) v krvi.
Odefsey: Emtricitabine and tenofovir alafenamide exposures were bioequivalent when comparing one Odefsey 200/25/25 mg film-coated tablet to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (150/150/200/10 mg) fixed-dose combination tablet following single dose administration to healthy subjects (n = 82) under fed conditions. 
Zdravilo Odefsey: Biološka enakovrednost izpostavljenosti emtricitabinu in tenofoviralafenamidu je bila ugotovljena pri primerjavi ene filmsko obložene tablete zdravila Odefsey 200/25/25 mg s tableto s fiksno kombinacijo odmerkov elvitegravirja/kobicistata/emtricitabina/tenofoviralafenamida
In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of E/C/F/TAF FDC tablet were evaluated in an open-label study of 50 HIV-1 infected, treatment-naïve adolescents. 
Režim, ki vsebuje emtricitabin + tenofoviralafenamid V študiji GS-US-292-0106 so ocenili učinkovitost, varnost in farmakokinetiko tablet E/C/F/TAF FDC v odprti študiji s 50 predhodno nezdravljenimi mladostniki, okuženimi s HIV1.
EFV + FTC/TDF (n = 546) 
FTC/TDF (n = 437)
Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1 
famotidin (40 mg enkratni odmerek, vzet 2 ur pred rilpivirinom)/rilpivirin1
Patients receiving Odefsey may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases. 
Pri bolnikih, ki se zdravijo z zdravilom Odefsey, se lahko še naprej razvijajo oportunistične okužbe in drugi zapleti okužbe z virusom HIV.
You must remain under the care of your doctor while taking Odefsey. 
Pri jemanju zdravila Odefsey morate ostati pod zdravniškim nadzorom.
ANTIARRHYTHMICS Digoxin/ Rilpivirine 
Protivirusna zdravila ledipasvir/sofosbuvir
The safety of emtricitabine + tenofovir alafenamide was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112), in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet. 
(GS-US-292-0112), v kateri je 248 bolnikov, okuženih s HIV-1, ki se bodisi predhodno še niso zdravili (n = 6) ali so imeli virusno supresijo (n = 242), z blago do zmerno ledvično okvaro (ocenjena hitrost glomerularne filtracije po metodi Cockcroft-Gault [eGFRCG]: 30-69 mL/min) prejemalo emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
Co-administration may cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp). 
Sočasna uporaba lahko pomembno zmanjša koncentracije rilpivirina (indukcija encimov CYP3A) in tenofoviralafenamida (indukcija P-gp) v plazmi.
The combination of Odefsey with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp). 
Kombinacija zdravila Odefsey s temi makrolidnimi antibiotiki lahko povzroči povečanje koncentracij rilpivirina (zaviranje encimov CYP3A)
Emtricitabine/Rilpivirine/Tenofovir alafenamide (200 mg/25 mg/25 mg once daily) 
voksilaprevir (400 mg/100 mg/100 mg + 100 mg enkrat dnevno)3/ emtricitabin/rilpivirin/ tenofoviralafenamid (200 mg/25 mg/25 mg once daily)
Co-administration of ciclosporin is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp). 
Pričakuje se, da bo sočasna uporaba ciklosporina povečala koncentracije rilpivirina (zaviranje encimov CYP3A) in tenofoviralafenamida (indukcija P-gp) v plazmi.
AUC: ↓ 24% Cmin: ↓ 66% Cmax: ↔ 
ketokonazol: AUC: ↓ 24 % Cmin: ↓ 66 % Cmax: ↔
• feeling sick (nausea) 
• omotičnost • občutek siljenja na bruhanje (navzea)
The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813). 
664 celic/mm3 (razpon 126-1.813).
Small improvements in BMD were noted at 48 weeks after switching to E/C/F/TAF compared to maintaining the tenofovir disoproxil fumarate-containing regimen. 
V primerjavi z režimom, ki vsebuje dizoproksiltenofovirijev fumarat, so po prehodu na E/C/F/TAF po 48 tednih zdravljenja opazili majhno izboljšanje MGK.
Cmax: ↑ 21% Sofosbuvir metabolite GS-331007: 
presnovek sofosbuvirja GS-331007: AUC: ↑ 8 %
0% (95% CI: -4.8% to 4.8%) 
-4,8 % do 4,8 %)
Pharmacokinetics in special populations 
Farmakokinetika pri posebnih populacijah Starost, spol in etnična pripadnost
The pharmacokinetics, safety, tolerability, and efficacy of rilpivirine 25 mg once daily, in combination with an investigator-selected BR containing two NRTIs, were evaluated in Study TMC278-C213, a single-arm, open-label Phase 2 study in antiretroviral-naïve HIV-1 infected paediatric patients 12 to < 18 years of age and weighing at least 32 kg. 
prenašanje in učinkovitost 25 mg rilpivirina enkrat dnevno v kombinaciji z osnovno shemo zdravljenja po izbiri raziskovalca, ki vsebuje dva NRTI, pri pediatričnih bolnikih, okuženih z virusom HIV-1, ki se predhodno niso zdravili s protiretrovirusnimi zdravili, starih od 12 do < 18 let s telesno maso najmanj 32 kg. Mediana trajanja izpostavljenosti za bolnike je bila 63,5 tednov.
Children and adolescents Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg. 
Otrokom, starim 11 let ali manj, ali s telesno maso manj kot 35 kg, ne dajajte tega zdravila.
AUC: ↓ 16% Cmin: ↓ 21% Cmax: ↓ 13% 
S(+) metadon: AUC: ↓ 16 % Cmin: ↓ 21 % Cmax: ↓ 13 %
One patient with emergent resistance (M184M/I) was identified in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine + tenofovir disoproxil fumarate to E/C/F/TAF in a fixed-dose combination (FDC) tablet (GS-US-292-0109, n = 959). 
V klinični študiji pri bolnikih z virološko supresijo, ki so prešli z režima, ki je vseboval emtricitabin + dizoproksiltenofovirijev fumarat, na E/C/F/TAF v obliki tablete s fiksno kombinacijo odmerkov (FDC) (GS-US-292-0109, n = 959), je bil opredeljen en bolnik s pojavom rezistence (M184M/I).
In a clinical study of HIV virologically suppressed patients co-infected with chronic hepatitis B, who received E/C/F/TAF for 48 weeks (GS-US-292-1249, n = 72), 2 patients qualified for resistance analysis. 
ki so 48 tednov prejemali E/C/F/TAF (GS-US-292-1249, n = 72), sta bila 2 bolnika primerna za analizo rezistence.
Inhibition of CYP3A Expected: 
Zaviranje encimov CYP3A
(78.6%, 22/28) as compared to those with a baseline viral load > 100,000 copies/mL (50.0%, 4/8). 
> 100.000 kopij/ml (50,0 %, 4/8).
AUC: ↑ 8% 
Cmax: ↑ 8 %
Induction of CYP3A Expected: 
Indukcija encimov CYP3A
tenofovir alafenamide tenofovir disoproxil lamivudine adefovir dipivoxil 
tenofoviralafenamid dizoproksiltenofovirat lamivudin dipivoksiladefovirat
The proportion of patients with HIV-1 RNA < 50 copies/mL at Week 48 (TLOVR) was 72.2% (26/36). 
Na začetku je bila mediana plazemska HIV-1 RNA 4,8 log10 kopij/ml, mediano število celic CD4+ je bilo 414 celic/mm3 (razpon: Delež bolnikov s HIV-1 RNA < 50 kopij/ml v 48. tednu (TLOVR) je bil 72,2 % (26/36).
Co-administration of these antifungal agents is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp). 
Pričakuje se, da bo sočasna uporaba teh antimikotikov povzročila povečanje koncentracij rilpivirina (zaviranje encimov CYP3A) in tenofoviralafenamida (zaviranje P-gp) v plazmi.
Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily) 
Priporočilo glede sočasne uporabe z zdravilom Odefsey sofosbuvir (400 mg enkrat dnevno)/rilpivirin (25 mg enkrat dnevno)
-2.0% (95% CI: -5.9% to 1.8%) 
-5,9 % do 1,8 %)
Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet (E/C/F/TAF) in Study GS-US-292-1825 were significantly higher than in patients with normal renal function. 
Izpostavljenosti emtricitabinu in tenofovirju pri 12 bolnikih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi, ki so prejemali emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov
Odefsey should not be co-administered with other medicinal products containing tenofovir alafenamide, lamivudine, tenofovir disoproxil or adefovir dipivoxil (see section 4.5). 
Zdravila Odefsey se ne sme dajati skupaj z zdravili, ki vsebujejo tenofoviralafenamid, lamivudin,
The mean baseline CD4+ cell count was 709 cells/mm3 (range 104-2,527). 
Povprečno število celic CD4+ na začetku je bilo 709 celic/mm3
Exposures of emtricitabine and tenofovir alafenamide given with elvitegravir + cobicistat achieved in 24 paediatric patients aged 12 to < 18 years were similar to exposures achieved in treatment-naïve adults (Table 6). 
ki jih je doseglo 24 pediatričnih bolnikov, starih 12 do < 18 let, so bile podobne izpostavljenostim,
No dose adjustment of Odefsey is required in adults or in adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min. 
Odmerka zdravila Odefsey pri odraslih ali mladostnikih (starih vsaj 12 let in s telesno maso vsaj
Overall response (HIV-1 RNA < 50 copies/mL (TLOVRa))b 
Celokupni odziv (HIV-1 RNA
The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet. 
Varnost emtricitabina + tenofoviralafenamida so ocenili v 48 tednih z odprto klinično študijo (GS-US-292-0106), v kateri so predhodno nezdravljeni pediatrični bolniki, okuženi s HIV-1 in stari od
Co-administration is likely to cause significant decreases in the plasma concentrations of tenofovir alafenamide (induction of P-gp). 
Verjetno je, da bo sočasna uporaba povzročila pomembno zmanjšanje koncentracij tenofoviralafenamida v plazmi
ANTIDIABETICS Metformin (850 mg single dose)/ Rilpivirine 
ANTIDIABETIKI metformin (enkratni odmerek 850 mg)/rilpivirin metformin: AUC: ↔ Cmin: N/A Cmax: ↔
• Periodic Safety Update Reports 
*na podlagi zgodovinskih kontrol
The mean baseline CD4+ cell count was 697 cells/mm3 (range 
Povprečno število celic CD4+ na začetku je bilo 700 celic/mm3
Tablet core: 
Torsade de Pointes.
fatigue1, 3 
utrujenost1,3
Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Tenofovir alafenamide 
(90 mg/400 mg enkrat dnevno)/tenofoviralafenamid tenofoviralafenamid:
ORAL CONTRACEPTIVES Ethinylestradiol (0.035 mg once daily)/ Rilpivirine 
PERORALNI KONTRACEPTIVI etinilestradiol (0,035 mg enkrat dnevno)/rilpivirin noretindron (1 mg enkrat dnevno)/rilpivirin etinilestradiol: AUC: ↔ Cmin: ↔ Cmax: ↑ 17 %
0.7% (95% CI: -4.3% to 5.8%) 
0,7 % (95 % IZ:
PROTON PUMP INHIBITORS Omeprazole (20 mg once daily)/ Rilpivirine1 
omeprazol (20 mg enkrat dnevno)/rilpivirin1
Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased tenofovir alafenamide exposure (AUC) by 45-53%. 
Odefsey zdravim odraslim osebam z obrokom, povzročilo večjo izpostavljenost tenofoviralafenamidu
QT prolonging medicinal products 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
and CD4+ T-lymphocytes. 
CYP2D6.
The safety of emtricitabine + tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [E/C/F/TAF]) was evaluated in 72 HIV/HBV co-infected patients receiving treatment for HIV in an open-label clinical study (GS-US-292-1249), through Week 48, in which patients were switched from another antiretroviral regimen (which included TDF in 69 of 72 patients) to E/C/F/TAF. 
HIV v odprti klinični študiji (GS-US-292-1249) do konca 48. tedna, v kateri so bolniki prešli z drugega protiretrovirusnega režima (ki je vključeval TDF pri 69 od 72 bolnikov) na E/C/F/TAF.
• hives (urticaria) 
• koprivnica (urtikarija)
This effect was maintained for almost one year. 
Ta učinek je trajal skoraj eno leto.
The recommended dose is 11 mg per kilogram body weight, and the infusion should last around one hour. 
Priporočeni odmerek je 11 mg na kilogram telesne mase, infuzija pa traja približno eno uro.
The Agency also acknowledged that there is an unmet medical need for these patients. 
Agencija je tudi menila, da za te bolnike ostaja neizpolnjena medicinska potreba.
What measures are being taken to ensure the safe and effective use of Sylvant? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sylvant?
The most serious side effect is anaphylactic reaction (a severe allergic reaction). 
Najresnejši neželeni učinek je anafilaktična reakcija (huda alergijska reakcija).
Sylvant received a marketing authorisation valid throughout the EU on 22 May 2014. 
Za zdravilo Sylvant je bilo 22. maja 2014 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Sylvant's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Sylvant večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The company will ensure that healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry. 
Podjetje bo zagotovilo, da bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo, poučeni o tem, kako vnesti bolnike v register.
What benefits of Sylvant have been shown in studies? 
Kakšne koristi zdravila Sylvant so se pokazale v študijah?
Further information on Sylvant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije za zdravilo Sylvant so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
As for all medicines, data on the use of Sylvant are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Sylvant stalno spremljajo.
For more information about using Sylvant, see the summary of product characteristics or contact a doctor or pharmacist. 
Za več informacij glede uporabe zdravila Sylvant glejte povzetek glavnih značilnosti zdravila ali se posvetujte z zdravnikom ali farmacevtom.
During the first 12 months of treatment the patient should have a blood test before each dose of Sylvant, and every nine weeks afterwards; treatment may need to be delayed in patients whose blood tests are abnormal or who have certain side effects. 
V prvih 12 mesecih zdravljenja je treba pri bolniku pred posameznim odmerkom zdravila Sylvant in vsakih devet tednov po njem izvesti krvni test; zdravljenje je morda treba odložiti pri bolnikih, ki imajo nenormalni krvni test ali nekatere neželene učinke.
The Agency concluded that Sylvant has shown beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman's disease, and that this positive effect seems to be maintained over time. 
Agencija je zaključila, da je zdravilo Sylvant pokazalo pozitiven učinek glede zmanjševanja velikosti tumorjev in simptomov pri bolnikih z multicentrično Castlemanovo boleznijo ter da ta pozitivni učinek traja dalj časa.
The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety. 
Podjetje, ki trži zdravilo Sylvant, mora oblikovati register bolnikov, da se zagotovijo dodatni podatki o dolgoročni varnosti.
Sylvant is given every three weeks, until the patient no longer benefits from treatment. 
Zdravilo Sylvant se daje vsake tri tedne, dokler ima bolnik še koristi od zdravljenja.
Why is Sylvant authorised in the EU? 
Zakaj je bilo zdravilo Sylvant odobreno v EU?
Other information about Sylvant 
Druge informacije o zdravilu Sylvant
Side effects of Sylvant were considered acceptable but further long-term data are to be collected. 
Neželeni učinki zdravila Sylvant so sprejemljivi, vendar je treba zbrati dodatne dolgoročne podatke.
Multicentric means that the disease affects several lymph nodes as well as other organs in the body. 
Multicentrična pomeni, da bolezen vpliva na več bezgavk in drugih organov v telesu.
Side effects reported with Sylvant are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Sylvant, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sylvant have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Sylvant upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The effect of the medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients who responded to treatment for at least 18 weeks, as shown by a 50% reduction (‘partial response') or complete disappearance (‘complete response') of tumours and symptoms of the disease. 
Učinek zdravila so primerjali s placebom (zdravilom brez učinkovine), glavno merilo učinkovitosti pa je bil delež bolnikov, ki so se vsaj 18 tednov odzivali na zdravljenje, kar se je odražalo v 50-odstotnem zmanjšanju („delni odziv“) ali popolnem izginotju („popolni odziv“) tumorjev in simptomov bolezni.
What are the risks associated with Sylvant? 
Kakšna tveganja so povezana z zdravilom Sylvant?
Castleman's disease is rare, and Sylvant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 November 2007. 
Castlemanova bolezen je redka, zato je bilo zdravilo Sylvant 30. novembra 2007 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6). 
Siltuksimab je bil zasnovan tako, da se veže na beljakovino v telesu, ki se imenuje interlevkin 6 (IL-6).
An overview of Sylvant and why it is authorised in the EU 
Pregled zdravila Sylvant in zakaj je odobreno v EU
What is Sylvant and what is it used for? 
Kaj je zdravilo Sylvant in za kaj se uporablja?
Sylvant was more effective than placebo in reducing tumour size and disease symptoms: 17 out of 53 patients who received Sylvant showed a partial response and one showed a complete response, compared with none of the 26 patients who received placebo. 
Zdravilo Sylvant je bilo pri zmanjševanju velikosti tumorjev in bolezenskih simptomov učinkovitejše od placeba: pri 17 od 53 bolnikov, ki so prejeli zdravilo Sylvant, se je pokazal delni odziv in pri enem popolni odziv, medtem ko se ni odzval nobeden od 26 bolnikov, ki so prejeli placebo.
Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision. 
Predpisovanje in izdaja zdravila Sylvant je le na recept, zdravljenje pa lahko izvajajo samo usposobljeni zdravstveni delavci pod ustreznim zdravstvenim nadzorom.