FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not remove contents until all of the powder has been completely dissolved.
Slovenian: Vsebine ne odstranjujte iz viale, dokler se vsi trdni delci povsem ne raztopijo.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki razvrstitvi pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: It is not known if SYLVANT is safe and effective in this population, therefore SYLVANT should not be given to children and adolescents.
Slovenian: Ni znano ali je uporaba zdravila SYLVANT v tej populaciji varna in učinkovita, zato se zdravilo SYLVANT pri otrocih in mladostnikih ne sme uporabljati.
English: Common (may affect up to 1 in 10 people): • high level of cholesterol in the blood
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): • zvečana koncentracija holesterola v krvi
English: Women of childbearing potential must use effective contraception during and up to 3 months after treatment (see section 4.5).
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko metodo med zdravljenjem in še do 3 mesece po njegovem zaključku (glejte poglavje 4.5).
English: NL-2333 CB Leiden The Netherlands
Slovenian: NL-2333 CB Leiden
English: Patients should be managed according to current clinical guidelines for management of hyperlipidaemia.
Slovenian: Bolnike je treba zdraviti skladno z zadnjimi kliničnimi smernicami za zdravljenje hiperlipidemije.
English: Barnahely Ringaskiddy Co. Cork
Slovenian: Ringaskiddy Co. Cork Irska
English: Median duration of siltuximab treatment was 5.52 years (range: 0.8 to 10.8 years); more than 50% of patients received siltuximab treatment for ≥5 years.
Slovenian: Mediana trajanja zdravljenja s siltuksimabom je bila 5,52 let (razpon: 0,8 do 10,8 let); več kot 50% bolnikov je prejemalo siltuksimab ≥5 let.
English: SYLVANT does not contain preservatives; therefore do not store any unused portion of the infusion solution for re-use.
Slovenian: Zdravilo SYLVANT ne vsebuje konservansov, zato neporabljene infuzijske raztopine ne shranjujte za ponovno uporabo.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če zdravilo ne bo porabljeno takoj po pripravi in redčenju, je za čas in pogoje shranjevanja odgovoren uporabnik.
English: This leaflet was last revised in MM/YYYY Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL Drugi viri informacij
English: In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Slovenian: Za zagotavljanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije danega zdravila.
English: After a median of 6 years of follow-up, none of the 60 patients had died and maintenance of disease control was demonstrated in 58 of 60 patients.
Slovenian: Po obdobju spremljanja, ki je trajalo mediano 6 let, je preživelo vseh 60 bolnikov, pri 58 od 60 bolnikov pa je bila bolezen pod nadzorom.
English: If you are pregnant or breast-feeding, think that you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to zdravilo.
English: 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
Slovenian: A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Treatment was continued until treatment failure (defined as disease progression based on increase in symptoms, radiologic progression or deterioration in performance status) or unacceptable toxicity.
Slovenian: Zdravljenje so nadaljevali, dokler ni prišlo do neuspeha zdravljenja (ki je bil opredeljen kot napredovanje bolezni s poslabšanjem simptomov, radiološko potrjenim napredovanjem bolezni ali poslabšanjem telesne zmogljivosti bolnika) ali do nesprejemljivega toksičnega učinka zdravila.
English: • drop in the number of white blood cells (neutropenia)
Slovenian: • zmanjšanje števila belih krvnih celic (nevtropenija)
English: SYLVANT is not likely to affect your ability to drive, cycle, or use any tools or machines.
Slovenian: Ni verjetno, da bi zdravilo SYLVANT vplivalo na vašo sposobnost vožnje motornih vozil ali kolesa in uporabe naprav ali strojev.
English: The safety and efficacy of siltuximab in children aged 17 years and younger have not been established.
Slovenian: Varnost in učinkovitost siltuksimaba pri otrocih, starih 17 let ali manj, nista bili dokazani.
English: You should not stop using SYLVANT without discussing with your doctor first.
Slovenian: Z uporabo zdravila SYLVANT ne smete prenehati, ne da bi se o tem prej pogovorili z zdravnikom.
English: Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6).
Slovenian: Po pripravi in redčenju Dokazano je, da je raztopina pri sobni temperaturi kemijsko in fizikalno stabilna do 8 ur (glejte poglavje 6.6).
English: < 1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000).
Slovenian: (≥1/10.000 in <1/1.000); zelo redki (<1/10.000).
English: • SYLVANT will be given as an “intravenous infusion” (a drip into a vein, usually in your arm).
Slovenian: • Zdravilo SYLVANT boste prejemali v obliki intravenske infuzije (skozi cevko v veno, običajno na roki).
English: Siltuximab should be given to a pregnant woman only if the benefit clearly outweighs the risk.
Slovenian: Nosečnice smejo prejemati siltuksimab samo kadar koristi zdravljenja nedvomno presegajo tveganja.
English: Other medicines and SYLVANT
Slovenian: Druga zdravila in zdravilo SYLVANT
English: Treatment criteria
Slovenian: Kriteriji za zdravljenje
English: All tumour responses were durable for > 18 weeks.
Slovenian: Vsi tumorski odzivi so trajali več kot 18 tednov.
English: Clinical efficacy and safety
Slovenian: Klinična učinkovitost in varnost Študija 1
English: Infusion related reactions and hypersensitivity
Slovenian: Infuzijske reakcije in preobčutljivost
English: • oral contraceptives, used to prevent pregnancy.
Slovenian: • peroralni kontraceptivi za preprečevanje zanositve.
English: 2333 CB Leiden The Netherlands
Slovenian: 2333 CB Leiden
English: The European Medicines Agency has waived the obligation to submit the results of studies with siltuximab in all subsets of the paediatric population in CD (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s siltuksimabom za vse podskupine pediatrične populacije s Castlemanovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If you think you have been given too much SYLVANT, tell your doctor or nurse straight away.
Slovenian: Če menite, da ste prejeli preveč zdravila SYLVANT, takoj opozorite zdravnika ali medicinsko sestro.
English: • you are due to have a vaccination or may need to have one in the near future - this is because some vaccines should not be given with SYLVANT.
Slovenian: • če se ravno nameravate cepiti ali če boste cepivo morda potrebovali v bližnji prihodnosti - med zdravljenjem z zdravilom SYLVANT namreč ne smete prejeti nekaterih cepiv.
English: Durable complete symptomatic responsed Duration of durable complete symptomatic response (days) median (min, max)
Slovenian: trajni popolni simptomatski odzivd trajanje trajnega popolnega simptomatskega odziva (dnevi), mediana vrednost (najmanjša ,
English: Live, attentuated vaccines should not be given concurrently or within 4 weeks before initiating SYLVANT as clinical safety has not been established.
Slovenian: Bolniki ne smejo prejeti živih atenuiranih cepiv sočasno ali v roku 4 tednov pred začetkom uporabe zdravila SYLVANT, saj klinična varnost ni bila dokazana.
English: Further immunogenicity analyses were conducted for all positive samples from the 4 patients with detectable anti-siltuximab antibodies.
Slovenian: Nadaljnje analize imunogenosti so izvedli pri vseh pozitivnih vzorcih 4 bolnikov z merljivimi protitelesi proti siltuksimabu.
English: A decision must be made whether to discontinue breast-feeding or discontinue/abstain from siltuximab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s siltuksimabom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Alternatively PE bottles may be used.
Slovenian: Uporablja se lahko tudi PE plastenke.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o rekonstituciji in redčenju zdravila pred dajanjem glejte poglavje 6.6.
English: The infusion should be completed within 6 hours of the addition of the reconstituted solution to the infusion bag.
Slovenian: Infundiranje je treba zaključiti v roku 6 ur od dodajanja rekonstituirane raztopine v infuzijsko vrečko.
English: Name and address of the manufacturers of the biological active substances
Slovenian: Ime in naslov izdelovalcev biološke učinkovine
English: However, there is also evidence to suggest that IL-6 inhibition may suppress immune responses, immune surveillance and lower defense against established tumours.
Slovenian: Vendar pa obstoječi podatki kažejo tudi, da zaviranje IL-6 lahko zavre imunski odgovor, zmanjša imunski nadzor in obrambo proti prisotnim tumorjem.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: EU/1/14/928/001 (100 mg) EU/1/14/928/002 (400 mg)
Slovenian: EU/1/14/928/002 (400 mg)
English: 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).
Slovenian: V odprti, multicentrični, nerandomizirani študiji faze 2 so ocenjevali varnost in učinkovitost zdravljenja s siltuksimabom pri 60 bolnikih z MCD, ki so bili predhodno vključeni v študijo 1 (41 bolnikov) ali študijo 2 (19 bolnikov).
English: • In some cases, if you are pregnant and need treatment for MCD, your doctor may advise that the benefit of taking SYLVANT for your health outweighs the possible risks to your unborn baby, including increased risk of infection and use of certain vaccines in babies born to mothers exposed to SYLVANT while pregnant.
Slovenian: • Če ste noseči in je potrebno zdravljenje multicentrične Castelmanove bolezni, vam v nekaterih primerih zdravnik lahko svetuje, da prednosti zdravljenja z zdravilom SYLVANT odtehtajo tveganja za vašega nerojenega otroka, kar vključuje povečano tveganje za okužbo in tveganja uporabe določenih cepiv pri otrocih mater, ki so bile med nosečnostjo izpostavljene zdravilu
English: As with all therapeutic proteins, there is potential for the generation of anti-medicine antibodies (immunogenicity).
Slovenian: Imunogenost Kot pri vseh terapevtskih proteinih obstaja možnost za razvoj protiteles proti zdravilu (imunogenost).
English: • Use aseptic technique.
Slovenian: • Uporabljajte aseptično tehniko priprave.
English: Histopathological examination of lymphoid tissues from GD140 fetuses showed no morphological abnormalities in the development of the immune system.
Slovenian: Histopatološki pregled limfatičnega tkiva ploda na 140. dan brejosti ni pokazal morfoloških nepravilnosti v razvoju imunskega sistema.
English: Symptoms of this disease may include feeling tired, sweating at night, having a tingling feeling, and loss of appetite.
Slovenian: Simptomi te bolezni so lahko utrujenost, nočno znojenje, občutek mravljinčenja in izguba apetita.
English: Paediatric population No interaction studies have been performed in this population.
Slovenian: Pediatrična populacija Študij medsebojnega delovanja zdravil v tej populaciji niso izvedli.
English: 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.
Slovenian: Ugotovili so, da je IL-6 vpleten v različne normalne fiziološke procese, kot so indukcija sekrecije imunoglobulinov, prva stopnja sinteze proteinov akutne faze v jetrih in stimulacija proliferacije in diferenciacije prekurzorskih hematopoetskih celic.
English: • Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: • Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: A total score of all symptoms (referred to as the MCD-related Overall Symptom Score) is the sum of the severity grades (NCI-CTCAE grade) of the MCD-related signs and symptoms [general MCD-related (fatigue, malaise, hyperhidrosis, night sweats, fever, weight loss, anorexia, tumour pain, dyspnea, and pruritus), autoimmune phenomena, fluid retention, neuropathy, and skin disorders].
Slovenian: Skupna ocena vseh simptomov (skupna ocena simptomov multicentrične Castlemanove bolezni po MCD-related Overall Symptom Score) je vsota vseh stopenj izraženosti (po NCI-CTCAE*) znakov in simptomov multicentrične Castlemanove bolezni [splošnih simptomov multicentrične Castlemanove bolezni (utrujenosti, splošnega slabega počutja, prekomernega znojenja, nočnega znojenja, zvišane telesne temperature, izgubljanja telesne mase, anoreksije, tumorske bolečine, dispneje in srbenja), izražanja avtoimunskih dogajanj, zastajanja tekočine, nevropatije in kožnih sprememb].
English: On the basis of limited experience with siltuximab the present data do not suggest any increased risk of malignancy.
Slovenian: Trenutni podatki (na osnovi omejenih izkušenj s siltuksimabom) ne kažejo povečanega tveganja za malignome.
English: If you are given more SYLVANT than you should
Slovenian: Če ste prejeli večji odmerek zdravila SYLVANT, kot bi smeli
English: Use aseptic technique.
Slovenian: Uporabljajte aseptično tehniko priprave.
English: SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute-phase reactants, such as C-reactive protein (CRP).
Slovenian: Zdravilo SYLVANT lahko prikrije znake in simptome akutnega vnetja, vključno z zvišano telesno temperaturo in pojavljanjem beljakovin akutne faze, kot je C-reaktivni protein (CRP).
English: The effect of siltuximab on CYP450 enzyme activity can persist for several weeks after stopping therapy.
Slovenian: Učinek siltuksimaba na encimsko aktivnost CYP450 lahko traja še nekaj tednov po koncu zdravljenja.
English: In this study 37 patients with CD (35 MCD patients) were treated with siltuximab.
Slovenian: V tej študiji so s siltuksimabom zdravili 37 bolnikov s CD (o tega 35 bolnikov z MCD).
English: EUSA Pharma (Netherlands) B.V.
Slovenian: (Netherlands) B.V.
English: If you stop treatment with SYLVANT
Slovenian: Če ste prenehali uporabljati zdravilo SYLVANT
English: Key efficacy results from Study 1 are summarised in Table 3.
Slovenian: Glavni rezultati za oceno učinkovitosti iz študije 1 so navedeni v preglednici 3.
English: • The recommended dose is 11 milligrams per kilogram of body weight, given once every
Slovenian: • Priporočeni odmerek je 11 miligramov na kilogram telesne mase enkrat na 3 tedne.
English: 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.
Slovenian: Okužbe (vključno z okužbami zgornjih dihal), srbenje, izpuščaj, artralgija in driska so najbolj pogosti neželeni učinki v kliničnih študijah Castlemanove bolezni, ki so se pojavili pri > 20% bolnikov zdravljenih s siltuksimabom.
English: Contents of the pack and other information What SYLVANT contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo SYLVANT
English: Two cases of reactivated hepatitis B have been reported when SYLVANT was administered concomitantly with high dose dexamethasone, and bortezomib, melphalan and prednisone in multiple myeloma patients.
Slovenian: Poročali so o dveh primerih reaktivacije hepatitisa B, ko je bilo zdravilo SYLVANT uporabljeno sočasno z velikim odmerkom deksametazona ter bortezomibom, melfalanom in prednizolonom pri bolnikih z diseminiranim plazmocitomom.
English: • severe allergic reaction - the signs may include: difficulty breathing, chest tightness, wheezing,
Slovenian: • huda alergijska reakcija - znaki so lahko oteženo dihanje, tiščanje v prsih, piskanje v pljučih,
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Slovenian: Zdravnika ali farmacevta obvestite če jemljete katero od naslednjih zdravil:
English: • theophylline, used to treat asthma
Slovenian: • teofilin za zdravljenje astme
English: 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.
Slovenian: Celokupna pogostnost merljivih protiteles proti siltuksimabu je bila 0,9% (4/432) in 2,1% (4/189) pri bolnikih, pri katerih so testirali vsaj en vzorec z metodo ECLIA.
English: 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.
Slovenian: Multinacionalno, randomizirano (2:1), dvojno slepo, s placebom kontrolirano študijo faze II so izvedli za oceno učinkovitosti in varnosti siltuksimaba (11 mg/kg vsake 3 tedne) v primerjavi s placebom v kombinaciji z najboljšo podporno oskrbo pri bolnikih z multicentrično Castlemanovo boleznijo.
English: Within the system organ class, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to
Slovenian: V okviru vsakega organskega sistema so neželeni učinki navedeni po pogostnosti, ki je opredeljena z naslednjima kategorijama: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥1/1.000 in <1/100); redki
English: The mechanism of action of siltuximab is neutralisation of IL-6 bioactivity, which can be measured indirectly by suppression of CRP.
Slovenian: Mehanizem delovanja siltuksimaba je nevtralizacija biološke aktivnosti IL-6, ki jo je mogoče posredno meriti z obsegom supresije CRP.
English: SYLVANT 100 mg powder for concentrate for solution for infusion EU/1/14/928/001
Slovenian: SYLVANT 100 mg prašek za koncentrat za raztopino za infundiranje EU/1/14/928/001
English: Pharmacotherapeutic group: Immunosuppresants, interleukin inhibitors, ATC code: L04AC11.
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci interlevkina, oznaka ATC: L04AC11.
English: It is not known what the possible side effects could be from having too much SYLVANT.
Slovenian: Ni znano, do kakšnih neželenih učinkov bi lahko prišlo zaradi prejema prevelike količine zdravila SYLVANT.
English: Evidence from studies conducted with siltuximab and other IL-6 inhibitors suggest that the potential for siltuximab to cause carcinogenicity is low.
Slovenian: Dokazi iz študij siltuksimaba in drugih zaviralcev IL-6 kažejo ja je kancerogeni potencial siltuksimaba majhen.
English: 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).
Slovenian: Previdnost je potrebna tudi pri bolnikih, ki sočasno prejemajo siltuksimab in zdravila, ki so substrati CYP3A4, pri katerih zmanjšana učinkovitost (npr. peroralnega kontraceptiva) ni zaželjena.
English: 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).
Slovenian: Po večkratnem odmerjanju priporočenega odmerka je bil očistek siltuksimaba časovno nespremenljiv, sistemsko kopičenje pa je bilo zmerno (razmerje kopičenja 1,7).
English: Your doctor may stop your treatment with SYLVANT straight away.
Slovenian: Zdravnik bo morda takoj prekinil zdravljenje z zdravilom SYLVANT.
English: Studies in animals with siltuximab have shown no adverse effect on pregnancy or on embryofetal development (see section 5.3).
Slovenian: Študije siltuksimaba na živalih ne kažejo neželenih učinkov na nosečnost ali na embriofetalni razvoj (glejte poglavje 5.3).
English: Siltuximab clearance increased with increasing body weight; however, no dose adjustment is required for body weight since administration is on an mg/kg basis.
Slovenian: Očistek siltuksimaba se je povečeval z večjo telesno maso, vendar prilagajanje odmerjanja ni potrebno, saj se zdravilo odmerja glede na telesno maso (mg/kg).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA
English: Siltuximab treatment in MCD results in rapid and sustained decreases in CRP serum concentrations.
Slovenian: Zdravljenje Castlemanove bolezni s siltuksimabom povzroči hitro in trajno zmanjšanje koncentracije CRP v serumu.
English: It is not known if SYLVANT may affect the baby or a pregnant or breast-feeding woman.
Slovenian: Ni znano, ali zdravilo SYLVANT lahko škoduje otroku, nosečnici oziroma doječi materi.
English: 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.
Slovenian: Če v prvih 48 tednih zdravljenja več kot dvakrat odložite odmerjanje zaradi toksičnosti povezanih z zdravljenjem, je treba razmisliti o prenehanju zdravljenja s tem zdravilom.
English: In non-clinical studies, interleukin-6 (IL-6) is known to decrease the activity of cytochrome P450 (CYP450).
Slovenian: Iz predkliničnih študij je znano, da interlevkin-6 (IL-6) zmanjšuje aktivnost encimov citokroma P450
English: 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.
Slovenian: Po prvem odmerjanju siltuksimaba (z odmerki od 0,9 do 15 mg/kg) sta se krivulja časovnega poteka koncentracije (AUC) in najvišja koncentracija v serumu (Cmax) povečevali v odvisnosti od velikosti odmerka, očistek pa je bil neodvisen od velikosti odmerka.
English: Infections, including localised infections, should be treated prior to administration of SYLVANT.
Slovenian: Okužbe, vključno z lokaliziranimi, je treba pozdraviti pred odmerjanjem zdravila SYLVANT.
English: It is well established that IL-6 stimulates the acute-phase expression of C-reactive protein (CRP).
Slovenian: Znano je, da IL-6 stimulira ekspresijo C-reaktivnega proteina, ki je protein akutne faze.
English: Haematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every third dosing cycle thereafter.
Slovenian: V prvih 12 mesecih zdravljenja je treba laboratorijske preiskave krvi opraviti pred vsakim odmerjanjem zdravila SYLVANT in nato pred vsakim tretjim krogom odmerjanja.