natgillin/translations-raw huggingface dataset:
If bleeding occurs, apply a clean, dry cotton swab over the area, and press gently for 1 to 2 minutes, or until bleeding stops.
Če pride do krvavitve na tem mestu, ga pokrijte s čistim suhim bombažnim zložencem in nežno pritiskajte 1 do 2 minuti oziroma dokler se krvavitev ne ustavi, nato mesto prelepite z adhezivnim obližem.
Your doctor will discuss with you the need to start or adjust a urate lowering therapy to lower the uric acid level in your blood.
Zdravnik vam bo povedal, da morate začeti oziroma ustrezno spremeniti zdravljenje z zdravili za zmanjševanje količine urata, ki omogočajo znižanje koncentracije sečne kisline v krvi.
It is recommended that white blood cell (WBC) counts including neutrophil counts be assessed prior to initiating treatment and again after 1 to 2 months.
Določanje števila levkocitov vključno s številom nevtrofilcev je priporočeno pred začetkom zdravljenja in nato spet 1 do 2 meseca po začetku zdravljenja.
Check the expiry dates on the vial and syringes.
Preverite datum izteka roka uporabnosti zdravila na viali in na brizgah.
Patients who maintained inactive disease status for 6 additional months at this lowest dose regimen were allowed to discontinue canakinumab.
Bolnikom, ki so uspeli ohraniti status neaktivne bolezni dodatnih 6 mesecev, so dovolili, da prekinejo zdravljenje s kanakinumabom.
Formal carcinogenicity studies have not been conducted with canakinumab.
Formalnih študij kancerogenosti s kanakinumabom niso opravili.
Of the patients in clinical remission who continued with further dose reduction (1 mg/kg every 4 weeks) or dose interval prolongation (4 mg/kg every 12 weeks), 93% (26/28) and 91% (30/33) of patients, respectively, were able to maintain inactive disease status for 6 months.
Med bolniki, ki so bili v klinični remisiji in so nadaljevali zdravljenje z nadaljnjim znižanjem odmerka (1 mg/kg vsake 4 tedne) ali podaljšanjem odmernega intervala (4 mg/kg vsakih 12 tednov), jih je 93 % (26/28) oziroma 91 % (30/33) uspelo še 6 mesecev ohraniti status neaktivne bolezni.
After 24 weeks, 71% (27/38) of patients who received the reduced dose (2 mg/kg every 4 weeks) and 84% (31/37) of patients who received the prolonged dosing interval (4 mg/kg every 8 weeks) were able to maintain inactive disease status for 6 months.
Po 24 tednih je 71 % (27/38) bolnikov, ki so prejemali znižan odmerek (2 mg/kg vsake 4 tedne), in 84 % (31/37) tistih bolnikov, ki so zdravilo prejemali s podaljšanim intervalom (4 mg/kg vsakih 8 tednov), uspelo 6 mesecev ohranjati status neaktivne bolezni.
Find a clean place in which to prepare and give yourself the injection.
Poiščite čist prostor, v katerem boste pripravljali in si injicirali zdravilo.
For the primary efficacy endpoint, canakinumab was superior to placebo for all three disease cohorts.
Pri primarnem cilju študije je bil kanakinumab boljši od placeba v vseh treh kohortah.
Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype.
Kanakinumab je humano monoklonsko protitelo proti humanemu interlevkinu-1 beta (IL-1 beta) izotipa IgG1/κ.
Significant improvements were seen in physician's clinical assessment of autoinflammatory disease activity: global assessment of autoinflammatory disease activity, assessment of skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, assessment of other related symptoms, and patient's assessment of symptoms.
Pomembno izboljšanje so opažali pri zdravnikovi klinični oceni aktivnosti avotimunske bolezni: pri celotni oceni aktivnosti avtoimunske bolezni, pri oceni kožne bolezni (urtikarijski izpuščaj), artralgije, mialgije, glavobola/migrene, konjunktivitisa, utrujenosti/splošnega slabega počutja, pri oceni drugih povezanih simptomov in pri bolnikovi oceni simptomov.
What Ilaris is and what it is used for What you need to know before you use Ilaris How to use Ilaris
Kaj je zdravilo Ilaris in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ilaris Kako uporabljati zdravilo Ilaris Možni neželeni učinki
Although ≥ Grade 2 reductions in neutrophil count occurred in 6.5% of patients (common) and Grade 1 reductions occurred in 9.5% of patients, the reductions are generally transient and neutropenia-associated infection has not been identified as an adverse reaction.
Do znižanja števila nevtrofilcev stopnje ≥2 je prišlo pri 6,5 % bolnikov (pogosto), do znižanja stopnje 1 pa pri 9,5 % bolnikov, vendar so bila ta znižanja večinoma prehodna, med neželenimi učinki pa niso opažali z nevtropenijo povezanih okužb.
See also section 3, “Injecting Ilaris yourself or injecting a patient with Ilaris”.
Glejte tudi poglavje 3 "Samoinjiciranje zdravila Ilaris ali injiciranje zdravila Ilaris bolniku".
Corticosteroid dose tapering:
Postopno zniževanje odmerkov kortikosteroidov:
The risk for the development of malignancies with anti-interleukin (IL)-1 therapy is unknown.
Obseg tveganja za razvoj malignih bolezni pri zdravljenju z antagonisti interlevkina 1 (IL-1) ni znan.
Animal studies have shown that a murine anti-murine IL-1 beta antibody had no undesirable effects on development in nursing mouse pups and that the antibody was transferred to them (see section 5.3).
Študije na živalih so pokazale, da glodalsko protitelo proti glodalskemu IL-1 beta ni imelo neželenih učinkov na razvoj dojenih mišjih mladičev in da je to protitelo prehajalo k mladičem (glejte poglavje 5.3).
Overall, 33% (25/75) of patients randomised to dose reduction or dose interval prolongation arms were able to discontinue treatment with canakinumab and maintain inactive disease status for 6 months.
Skupno je 33 % (25/75) bolnikov, ki so jih randomizirali v skupini z znižanim odmerkom oziroma podaljšanim intervalom odmerjanja, uspelo prekiniti zdravljenje s kanakinumabom in 6 mesecev ohraniti status neaktivne bolezni.
Other medicines and Ilaris
Druga zdravila in zdravilo Ilaris
Never re-use the leftover solution.
Nikoli ne poskušajte ponovno uporabiti preostanka raztopine.
This patient presented at study entry with a history of immune thrombocytopenic purpura and an active medical condition of abnormal hepatic function.
Ob vstopu v študijo so pri temu bolniku zabeležili anamnezo imunske trombocitopenične purpure in aktivno bolezen z nepravilnim delovanjem jeter.
Canakinumab binds to serum IL-1 beta.
Kanakinumab se veže na IL-1 beta v serumu.
Long-term data and laboratory abnormalities in CAPS patients During clinical trials with canakinumab in CAPS patients mean values for haemoglobin increased and those for white blood cell, neutrophils and platelets decreased.
Dolgoročni podatki in patološki laboratorijski izvidi pri bolnikih s CAPS V kliničnih preskušanjih s kanakinumabom pri bolnikih s CAPS so se njihove vrednosti hemoglobina zvišale, vrednosti levkocitov, nevtrofilcev in trombocitov pa znižale.
Women who received canakinumab during pregnancy should be instructed to inform the baby's healthcare professional before any vaccinations are given to their newborn infant.
Ženske, ki v času nosečnosti prejemajo kanakinumab, morajo o tem obvestiti otrokovega zdravnika, preden novorojenček prejme katerokoli cepivo.
CAPS in children 2-< 4 years of age or children  4 years of age  7.5 kg and < 15 kg
CAPS pri otrocih, starih 2-< 4 leta, ali pri otrocih, starih  4 leta in z  7,5 kg ter < 15 kg
Packs containing 1 vial or multipacks containing 4 (4x1) vials.
Pakiranja vsebujejo 1 vialo, skupna pakiranja pa vsebujejo 4 viale (4x1 vialo).
Patients taking canakinumab in Part II had a 64% reduced risk of a flare event as compared to the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75; p=0.0032).
Pri bolnikih, ki so v 2. obdobju prejemali kanakinumab, je bilo tveganje za dogodke, ki pomenijo zagon bolezni, nižje za 64 % v primerjavi z bolniki v skupini s placebom (razmerje ogroženosti je bilo 0,36; 95-odstotni IZ: 0,17 do 0,75; p=0,0032).
The mean change in patient pain score (0-100 mm visual analogue scale) at day 15 was -50.0 mm for canakinumab (N=43), as compared to +4.5 mm for placebo (N=25).
Povprečna sprememba bolnikove ocene bolečine (0-100 mm na vizualni analogni lestvici) na 15. dan je bila -50,0 mm pri uporabi kanakinumaba (N=43) v primerjavi s +4,5 mm pri uporabi placeba (N=25).
A new flare was defined as a PGA score ≥ 2 (“mild, moderate, or severe disease”) and CRP ≥ 30 mg/l.
Nov zagon je bil opredeljen z oceno ≥ 2 na lestvici PGA (kar pomeni “blaga, zmerna ali huda aktivnost bolezni”) in vrednostjo CRP ≥ 30 mg/l.
Your doctor may want to check your vaccination history and give you any vaccinations that you have missed before you start treatment with Ilaris.
Vaš zdravnik bo morda hotel preveriti, proti čemu ste že bili cepljeni, in vas v primeru, da niste bili cepljeni po programu, dodatno cepiti še pred začetkom zdravljenja z zdravilom Ilaris.
Physicians should be attentive to symptoms of infection or worsening of Still's disease, as these are known triggers for MAS.
Zdravniki morajo biti pozorni na simptome okužbe ali poslabšanja Stillove bolezni, saj so to znani sprožilci sindroma aktivacije makrofagov.
The AUCss4w in each age group was 692, 615, 707 and 742 µg*d/ml for 2-3, 4-5, 6-11, and 12-19 years old, respectively.
Vrednosti AUCss v starostnih skupinah 2-3, 4-5, 6-11 in 12-19 let so znašale 692, 615, 707 in 742 µg*d/ml.
Study G2306
Študija G2306
If a patient becomes neutropenic or leukopenic, the WBC counts should be monitored closely and treatment discontinuation should be considered.
Če pride do nevtropenije ali levkopenije, je treba pri bolniku skrbno spremljati število levkocitov in razmisliti o prekinitvi zdravljenja.
Without touching the rubber stopper, swirl (do not shake) the vial slowly at an angle of about 45 degrees for about 1 minute.
Ne da bi se dotikali gumijastega zamaška, počasi vrtite vialo pod kotom približno 45 stopinj približno 1 minuto (viale pri tem ne stresajte).
What Ilaris is used for Ilaris is used for treatment of the following inflammatory diseases: - Periodic fever syndromes:
Za kaj uporabljamo zdravilo Ilaris Zdravilo Ilaris uporabljamo za zdravljenje naslednjih vnetnih bolezni: - periodični vročinski sindromi:
It is unknown whether canakinumab is excreted in human milk.
Ni znano, ali se kanakinumab izloča v materino mleko.
This may cause fever, headache, fatigue, skin rash, or painful joints and muscles.
To lahko povzroča simptome, kot so zvišana telesna temperatura, glavobol, utrujenost, kožni izpuščaj ter bolečine v sklepih in mišicah.
Resolution of disease flare was achieved by week 5 and the patient had not experienced any new flare at the end of Part II of the study (week 16).
Zagon bolezni je pri tem bolniku izzvenel do konca 5. tedna, nato pa pri bolniku ni prišlo do novega zagona do konca 2. obdobja v študiji (do konca 16. tedna).
Adverse reactions are listed according to MedDRA system organ class.
Neželeni učinki so navedeni glede na organski sistem po MedDRA klasifikaciji.
Insert the transfer needle through the centre of the stopper of the vial of Ilaris powder, taking care not to touch the needle or the stopper.
Iglo za prenos vstavite skozi osrednji del gumijastega zamaška viale s praškom Ilaris, pri tem pa pazite, da se ne dotaknete niti igle niti zamaška.
These data showed similar improvements from baseline to week 12 in the adapted paediatric ACR responses and its components to those observed in the placebo controlled study (G2305).
Ti podatki kažejo podobno izboljšanje po prirejenih pediatričnih kriterijih odziva ACR in po posameznih ocenah ACR kot pri rezultatih s placebom kontrolirane študije (G2305).
Macrophage activation syndrome in patients with Still's disease
Sindrom aktivacije makrofagov pri bolnikih s Stillovo boleznijo
Tip the vial to ensure that the required amount of solution can be drawn into the syringe.
Nagnite vialo, da boste lahko iz nje potegnili potrebno količino raztopine v brizgo.
No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving canakinumab.
O vplivu na cepljenje z živimi cepivi ali na sekundarni prenos okužb z živimi cepivi pri bolnikih, ki so prejemali kanakinumab, ni podatkov.
The Marketing Authorisation Holder has completed four Paediatric Investigation Plans for Ilaris (for CAPS, SJIA, FMF - HIDS/MKD and TRAPS respectively).
Imetnik dovoljenja za promet z zdravilom je izvedel štiri načrte pediatričnih raziskav za zdravilo Ilaris (in sicer za sindrome CAPS, SJIA, FMF - HIDS/MKD in TRAPS).
In approximately 12% of CAPS patients tested with a PPD (purified protein derivative) skin test in clinical trials, follow-up testing yielded a positive test result while treated with canakinumab without clinical evidence of a latent or active tuberculosis infection.
Pri približno 12 % bolnikov, ki imajo katerega od s kriopirinom povezanih periodičnih sindromov in so jim v kliničnih preskušanjih izvedli kožni test s PPD (s prečiščenim proteinskim derivatom), je pri kontrolnem testiranju v času zdravljenja s kanakinumabom prišlo do pozitivnih rezultatov, ne da bi imeli bolniki klinične znake latentne ali aktivne tuberkuloze.
Keep the needle all the way in the skin while slowly pushing the syringe plunger down until the barrel is empty.
Medtem ko je igla še vedno v celoti v kožni gubi, počasi potiskajte bat brizge navzdol, dokler brizge povsem ne izpraznite.
Allergic reactions with rash and itching and possibly also hives, difficulty breathing or swallowing, dizziness, unusual awareness of your heart beat (palpitations) or low blood pressure.
alergijske reakcije z izpuščajem in srbenjem, lahko tudi z urtikarijo, z oteženim dihanjem ali požiranjem, z omotičnostjo, z neprijetnim občutkom razbijanja srca (s palpitacijami) ali z nizkim krvnim tlakom.
All patients should be instructed to seek medical advice if signs or symptoms suggestive of tuberculosis (e.g. persistent cough, weight loss, subfebrile temperature) appear during canakinumab therapy.
Vsem bolnikom je treba naročiti, naj obiščejo zdravnika, če v času zdravljenja s kanakinumabom opazijo znake ali simptome, ki bi kazali na tuberkulozo (na primer trdovraten kašelj, zmanjševanje telesne mase, subfebrilne temperature).
Using an 18 G or 21 G x 2 inch needle (or similar as available on the market) and a 1 ml syringe, carefully withdraw the required volume depending on the dose to be administered.
Z uporabo igle 18 G ali 21 G x 2 palca (ali podobne igle, ki je na voljo na trgu) in 1-mililitrske injekcijske brizge previdno izvlecite toliko raztopine, kolikor je potrebno za injiciranje predpisanega odmerka.
For the overall study population, pain intensity was statistically significantly lower for canakinumab 150 mg compared with triamcinolone acetonide at 72 hours.
V celotni populaciji je bila intenzivnost bolečine 72 ur po odmerjanju statistično značilno manjša po uporabi kanakinumaba 150 mg v primerjavi z uporabo triamcinolon acetonida.
Prior to initiation of canakinumab therapy it is recommended that adult and paediatric patients receive all vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine (see section 4.5).
Priporočeno je, da odrasli in pediatrični bolniki že pred začetkom zdravljenja s kanakinumabom opravijo vsa cepljenja, ki jih potrebujejo, tudi cepljenje proti pnevmokoku in cepljenje z inaktiviranim virusom gripe (glejte poglavje 4.5).
Phase III trial, pivotal placebo-controlled withdrawal period (Part II) Canakinumab N=15 n(%)
Preskušanja faze III: obdobje s placebom kontroliranega opuščanja zdravila (2. obdobje) kanakinumab N=15 n(%)
Patients enrolled were aged 2 to < 20 years (mean age of 8.5 years and mean disease duration of 3.5 years at baseline) and had active disease defined as ≥ 2 joints with active arthritis, fever and elevated CRP.
Vključeni bolniki so bili stari od 2 do < 20 let (povprečna starost je znašala 8,5 let, povprečno trajanje bolezni ob izhodišču pa 3,5 let) in so imeli aktivno bolezen, opredeljeno z aktivnim artritisom v najmanj 2 sklepih, zvišano telesno temperaturo in zvišano vrednostjo C-reaktivnega proteina (CRP).
After proper training in the correct injection technique, patients or their caregivers may inject Ilaris if the physician determines that it is appropriate and with medical follow-up as necessary (see section 6.6).
Bolniki ali njihovi skrbniki smejo sami injicirati zdravilo Ilaris, če so se naučili pravilne tehnike injiciranja in če zdravnik presodi, da je to za njih primerno, in kasneje na ustrezen način preveri, če tako zdravljenje pri bolnikih pravilno poteka (glejte poglavje 6.6).
Canakinumab binds with high affinity specifically to human IL-1 beta and neutralises the biological activity of human IL-1 beta by blocking its interaction with IL-1 receptors, thereby preventing IL-1 beta-induced gene activation and the production of inflammatory mediators.
Kanakinumab se z veliko afiniteto specifično veže na humani interlevkin-1 beta in onemogoča njegovo biološko delovanje tako, da zavira njegovo interakcijo z receptorji za IL-1, s tem pa prepreči z IL-1 beta sproženo aktivacijo genov in tvorbo vnetnih mediatorjev.
Do not use after the expiry date which is stated on the label and carton.
Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
In clinical studies, CAPS, TRAPS, HIDS/MKD and FMF patients who have uncontrolled overproduction of IL-1 beta show a rapid and sustained response to therapy with canakinumab, i.e. laboratory parameters such as high C-reactive protein (CRP) and serum amyloid A (SAA), high neutrophil and platelet counts, and leukocytosis rapidly returned to normal.
V kliničnih študijah je pri bolnikih, ki so imeli katerega od sindromov CAPS, TRAPS, HIDS/MKD ali FMF in nenadzorovano prekomerno tvorbo IL-1 beta, prišlo do hitrega in dolgotrajnega odziva na zdravljenje s kanakinumabom, kar pomeni, da so se pri njih laboratorijski parametri, kot so koncentracije C-reaktivnega proteina (CRP), serumskega amiloida A (SAA) in zvišano število nevtrofilcev ter trombocitov in levkocitoza hitro vrnili na normalne vrednosti.
Preparing the injection
Pripravljanje injekcije
For maximum effect, canakinumab should be administered as soon as possible after the onset of a gouty arthritis attack.
Za doseganje največjega učinka mora bolnik prejeti kanakinumab čimprej po začetku napada uričnega artritisa.
It was estimated to be 6.2 litres in a CAPS patient of body weight 70 kg.
Ocenjujejo, da pri bolniku s CAPS, ki ima telesno maso 70 kg, znaša 6,2 litra.
The needle should not be in the liquid at this point.
Tokrat konica igle ne sme biti pokrita s tekočino.
After repeated subcutaneous administration of 150 mg every 4 weeks, canakinumab minimal concentration at week 16 (Cmin) was estimated to be 15.4 ± 6.6 g/ml.
Pri ponavljanju subkutanega odmerjanja 150 mg vsake 4 tedne je po 16 tednih ocenjena najnižja koncentracija kanakinumaba (Cmin) 15,4 ± 6,6 g/ml.
Secondary endpoints, all based on week 16 results (end of Part II), included the proportion of patients who achieved a PGA score of < 2, the proportion of patients with serological remission (defined as CRP ≤ 10 mg/l), and the proportion of patients with a normalised SAA level (defined as SAA ≤ 10 mg/l).
Vsi sekundarni cilji študije so izhajali iz rezultatov 16 tednov zdravljenja (ob zaključku 2. obdobja) in so vključevali delež bolnikov, ki so dosegli oceno < 2 na lestvici PGA, delež bolnikov s serološko remisijo (opredeljeno z vrednostjo CRP ≤ 10 mg/l) in delež bolnikov z normalizacijo vrednosti SAA (opredeljeno z vrednostjo SAA ≤ 10 mg/l).
Stopping your treatment with Ilaris may cause your condition to get worse.
Če prenehate uporabljati zdravilo Ilaris, se lahko vaša bolezen poslabša.
Time to flare:
Čas do zagona bolezni:
Study G2301
Študija G2301
Carefully withdraw the required volume depending on the dose to be administered (0.1 ml to 1 ml) and subcutaneously inject using a 27 G x 0.5 inch (13 mm) needle.
Previdno izvlecite toliko raztopine, kolikor je potrebno za injiciranje predpisanega odmerka (od 0,1 ml do 1 ml), in subkutano injicirajte raztopino z uporabo igle 27 G x 0,5 palca (13 mm).
• Patient Reminder Card
• opozorilno kartico za bolnika.
The efficacy of canakinumab for the treatment of acute gouty arthritis attacks was demonstrated in two multicentre, randomised, double-blind, active-controlled studies in patients with frequent gouty arthritis (≥ 3 attacks in the previous 12 months) unable to use NSAIDs or colchicine (due to contraindication, intolerance or lack of efficacy).
Učinkovitost kanakinumaba pri zdravljenju akutnih napadov uričnega artritisa so dokazali v dveh multicentričnih, randomiziranih, dvojno slepih, aktivno kontroliranih študijah z bolniki, ki so imeli pogoste napade uričnega artritisa (3 ali več napade v predhodnih 12 mesecih) in niso mogli uporabljati nesteroidnih protivnetnih zdravil ali kolhicina (zaradi kontraindikacij, neprenašanja ali nezadostnega učinka).
Women should use effective contraceptives during treatment with canakinumab and for up to 3 months after the last dose.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske morajo med zdravljenjem s kanakinumabom in do 3 mesece po zadnjem odmerku uporabljati učinkovita kontracepcijska sredstva.
Safety results showed an increased incidence of adverse events for canakinumab compared to triamcinolone acetonide, with 66% vs 53% of patients reporting any adverse event and 20% vs 10% of patients reporting an infection adverse event over 24 weeks.
Rezultati glede varnosti kažejo večjo pogostnost neželenih dogodkov pri uporabi kanakinumaba v primerjavi z uporabo triamcinolon acetonida, saj je v 24 tednih o neželenem dogodku poročalo 66 % bolnikov s kanakinumabom v primerjavi s 53 % bolnikov s triamcinolon acetonidom, o okužbi kot o neželenem dogodku pa je poročalo 20 % bolnikov s kanakinumabom v primerjavi z 10 % bolnikov s triamcinolon acetonidom.
Read these instructions all the way through before beginning.
Preden začnete, preberite ta navodila v celoti.
Ilaris is also indicated for the treatment of:
Zdravilo Ilaris je indicirano tudi za zdravljenje naslednjih dveh bolezni:
TRAPS, HIDS/MKD and FMF: Adults, adolescents and children aged 2 years and older The recommended starting dose of canakinumab in TRAPS, HIDS/MKD and FMF patients is:
Sindromi TRAPS, HIDS/MKD in FMF: odrasli, mladostniki in otroci, stari 2 leti ali več Priporočeni začetni odmerek kanakinumaba za bolnike, ki imajo sindrome TRAPS, HIDS/MKD ali FMF je:
The pivotal study consisted of a 48-week three-part multicentre study, i.e. an 8-week open-label period (Part I), a 24-week randomised, double-blind, placebo-controlled withdrawal period (Part II), followed by a 16-week open-label period (Part III).
Ena ključnih študij je bila multicentrična in je obsegala 48-tedensko zdravljenje v treh različnih obdobjih: 8-tedensko odprto zdravljenje (1. obdobje), 24-tedensko randomizirano dvojno slepo, s placebom kontrolirano obdobje opuščanja zdravila (2. obdobje), temu pa je sledilo 16-tedensko odprto zdravljenje (3. obdobje).
Ilaris contains the active substance canakinumab, a monoclonal antibody that belongs to a group of medicines called interleukin inhibitors.
Zdravilo Ilaris vsebuje učinkovino kanakinumab, ki je monoklonsko protitelo in sodi v skupino zdravil, ki jih imenujemo zaviralci interlevkina.
Allow to stand for about 15 minutes at room temperature to obtain a clear to opalescent solution.
Vialo spet pustite, da stoji približno 15 minut pri sobni temperaturi, da dobite bistro ali opalescentno raztopino.
Do not turn the vial and syringe upside down, the vial should stay upright.
Viale z brizgo ne obračajte na glavo, viala mora stati pokonci.
Appropriate screening tests (e.g. tuberculin skin test, interferon gamma release assay or chest X-ray) should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih je treba izvesti ustrezne presejalne teste (na primer tuberkulinski kožni test, gama interferonske teste ali rentgensko slikanje pljuč; v skladu z lokalnimi priporočili).