natgillin/translations-raw huggingface dataset:
Gather together the necessary items Included in the pack - one vial of Ilaris solution for injection (keep refrigerated)
Prikupite potrebne predmete Uključeno u pakiranje jedna bočica Ilaris otopine za injekciju (čuvati u hladnjaku)
Canakinumab should be used as an on-demand therapy to treat gouty arthritis attacks.
Kanakinumab se treba primjenjivati kao terapija u slučaju pojave simptoma za liječenje napada uričnog artritisa.
• 2 mg/kg for patients who weigh between 7.5 kg and less than 40 kg
• 2 mg/kg za bolesnike tjelesne težine između 7,5 kg i manje od 40 kg
Insert the needle all the way into the vial until it reaches the bottom edge.
Gurnite iglu do kraja u bočicu dok ne dođe do dna.
If a satisfactory clinical response has not been achieved 7 days after this increased dose, a third dose of canakinumab at 300 mg or 4 mg/kg can be considered.
Ako se zadovoljavajući klinički odgovor ne postigne 7 dana nakon te povećane doze, može se razmotriti treća doza kanakinumaba od 300 mg ili 4 mg/kg.
Solution for injection in a vial (type I glass) with a stopper (laminated chlorobutyl rubber) and flip-off cap (aluminium).
Otopina za injekciju u bočici (staklo tipa I) s čepom (laminirana klorobutilna guma) i flip-off kapicom (aluminij).
By blocking the activity of IL-1 beta, Ilaris may lead to an improvement in these symptoms.
Blokiranjem aktivnosti IL-1 beta Ilaris može dovesti do poboljšanja tih simptoma.
The recommended dose of canakinumab for adult patients with gouty arthritis is 150 mg administered subcutaneously as a single dose during an attack.
Preporučena doza kanakinumaba za odrasle bolesnike s uričnim artritisom je 150 mg i primjenjuje se supkutano kao jednokratna doza tijekom napada.
Packs containing 1 vial.
Pakiranja koja sadrže 1 bočicu.
Set the syringe aside.
Štrcaljku stavite sa strane.
• Neonatal-onset multisystem inflammatory disease (NOMID), also called chronic infantile neurological, cutaneous, articular syndrome (CINCA),
• Neonatalna multisistemska upalna bolest, koja se naziva i kroničnim infantilnim neurokutanim artikularnim sindromom,
Instructions for use of Ilaris powder for solution for injection
Upute za uporabu Ilaris praška za otopinu za injekciju
Keep the sharps container out of reach of children.
Čuvajte spremnik za oštre predmete izvan dohvata djece.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti nuspojave su prikazane od najozbiljnijih prema manje ozbiljnima.
TRAPS, HIDS/MKD and FMF patients with body weight  7.5 kg and ≤ 40 kg
TRAPS, HIDS/MKD i FMF u bolesnika tjelesne težine 7,5 kg i ≤40 kg
The recommended dose of canakinumab for patients with Still's disease (AOSD and SJIA) with body weight ≥ 7.5 kg is 4 mg/kg (up to a maximum of 300 mg) administered every four weeks via subcutaneous injection.
Preporučena doza kanakinumaba za oboljele od Stillove bolesti (SBOD i SJIA) s tjelesnom težinom ≥ 7,5 kg je 4 mg/kg (do najviše 300 mg) koji se primjenjuju svaka četiri tjedna supkutanom injekcijom.
For patients with a starting dose of 150 mg or 2 mg/kg, if a satisfactory clinical response (resolution of rash and other generalised inflammatory symptoms) has not been achieved 7 days after treatment start, a second dose of canakinumab at 150 mg or 2 mg/kg can be considered.
Za bolesnike s početnom dozom od 150 mg ili 2 mg/kg, ako se zadovoljavajući klinički odgovor (povlačenje osipa i drugih generaliziranih upalnih simptoma) ne postigne nakon 7 dana od početka liječenja, može se razmotriti druga doza kanakinumaba od 150 mg ili 2 mg/kg.
Ilaris is indicated for the treatment of active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.
Ilaris je indiciran za liječenje aktivne Stillove bolesti uključujući Stillovu bolest odrasle dobi (SBOD) i sistemski juvenilni idiopatski artritis (SJIA) u bolesnika u dobi od 2 i više godina koji nisu imali primjereni odgovor na prethodnu terapiju nesteroidnim protuupalnim lijekovima (NSAIL) i sistemskim kortikosteroidima.
What Ilaris looks like and contents of the pack Ilaris is supplied as a powder for solution for injection (150 mg in a 6 ml glass vial).
Ilaris se isporučuje kao prašak za otopinu za injekciju (150 mg u staklenoj bočici od 6 ml).
All up-titrated patients remained at the increased dose of 300 mg (or 4 mg/kg for patients ≤ 40 kg) every 4 weeks.
Svi bolesnici kojima je postupno povećana doza ostali su na povećanoj dozi od 300 mg (ili 4 mg/kg za bolesnike ≤40 kg) svaka 4 tjedna.
The recommended dose of Ilaris for patients with Still's disease (AOSD or SJIA) with body weight of 7.5 kg and above is 4 mg/kg (up to a maximum of 300 mg).
Preporučena doza Ilarisa za bolesnike sa Stillovom bolešću (SBOD ili SJIA) tjelesne težine od 7,5 kg i više je 4 mg/kg (do najviše 300 mg).
Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF).
Familial Mediterranean fever, FMF) Ilaris je indiciran za liječenje obiteljske mediteranske groznice (FMF).
The clinical impact of this is unknown.
Nije poznato kakav klinički učinak to ima.
If the child responds well enough to this, treatment may be continued with a dose of 8 mg/kg every 8 weeks.
Ako dijete ima dovoljno dobar odgovor na nju, liječenje se može nastaviti s dozom od 8 mg/kg svakih 8 tjedana.
Dispose of it as directed by your healthcare provider or pharmacist.
Odložite ga prema uputama zdravstvenog djelatnika ili ljekarnika.
Laboratory abnormalities in gouty arthritis patients Haematology
Laboratorijske abnormalnosti kod bolesnika s uričnim artritisom Hematologija
Properly dispose of vials containing remaining water and Ilaris solution (if any) as directed by your healthcare provider or pharmacist.
Pravilno odložite bočice koje sadrže preostalu vodu i Ilaris otopinu (ako je ima) prema uputama zdravstvenog djelatnika ili ljekarnika.
Time to flare:
Vrijeme do naglog pogoršanja bolesti:
Carefully remove the transfer needle from the vial and recap the needle as instructed by your healthcare provider or pharmacist.
Pažljivo izvucite iglu za prijenos iz bočice i vratite kapicu na iglu prema uputama koje ste dobili od zdravstvenog djelatnika ili ljekarnika.
Tap the side of the vial to remove any residual liquid from the stopper.
Lagano kucnite bočicu sa strane kako biste uklonili ostatak tekućine sa čepa.
For patients with a starting dose of 4 mg/kg, if a satisfactory clinical response has not been achieved 7 days after treatment start, a second dose of canakinumab 4 mg/kg can be considered.
Za bolesnike s početnom dozom od 4 mg/kg, ako se zadovoljavajući klinički odgovor ne postigne 7 dana nakon početka liječenja, može se razmotriti druga doza kanakinumaba od 4 mg/kg.
If you have CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA) and have forgotten to inject a dose of Ilaris, inject the next dose as soon as you remember.
Ako imate CAPS, TRAPS, HIDS/MKD, FMF ili Stillovu bolest (SBOD ili SJIA) i zaboravili ste ubrizgati dozu Ilarisa, ubrizgajte sljedeću dozu čim se sjetite.
Based on the population pharmacokinetic modelling analysis, the pharmacokinetics of canakinumab in children aged 2 to < 4 years were similar to those in patients 4 years of age and older.
Na temelju analize populacijskog farmakokinetičkog modeliranja, farmakokinetika kanakinumaba kod djece u dobi od 2 do <4 godine bila je slična onoj kod bolesnika u dobi od 4 i više godina.
In study G2305, the Childhood Health Assessment Questionnaire Least Squares means improvement was 0.69 for canakinumab vs placebo representing 3.6 times the minimal clinically important difference of 0.19 (p=0.0002).
Childhood Health Assessment Questionnaire) izračunato metodom najmanjih kvadrata bilo je 0,69 za kanakinumab u odnosu na placebo, što predstavlja vrijednost 3,6 puta veću od najmanje klinički važne razlike od 0,19 (p=0,0002).
Ilaris can be used together with colchicine, if appropriate.
Ilaris se može koristiti zajedno s kolhicinom, kada je primjereno.
Concomitant treatment with ULTs was reported by 42% of patients at entry.
Istodobno liječenje lijekovima za snižavanje urata (ULT) bilo je zabilježeno kod 42% bolesnika prilikom uključivanja u ispitivanje.
The expected accumulation ratio was 1.1-fold following subcutaneous administration of 150 mg canakinumab every 12 weeks.
Očekivani omjer akumulacije bio je 1,1 puta veći nakon supkutane primjene 150 mg kanakinumaba svakih 12 tjedana.
Table 3 Tabulated summary of efficacy in Phase III trial, pivotal, randomised, placebocontrolled treatment period (Part II)
Tablica 3 Tablični sažetak djelotvornosti u ispitivanju faze III, ključnom, randomiziranom, placebom kontroliranom razdoblju liječenja (II. dio)
Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).
D syndrome, HIDS)/nedostatak mevalonat kinaze (engl. mevalonate kinase deficiency, MKD) Ilaris je indiciran za liječenje sindroma hiperimunoglobulina D (HIDS)/nedostatka mevalonat kinaze (MKD).
TRAPS, HIDS/MKD and FMF patients with body weight > 40 kg
TRAPS, HIDS/MKD i FMF u bolesnika tjelesne težine >40 kg
- Part III: Patients who completed 16 weeks of treatment and were classified as responders were re-randomised into a 24-week, double-blind withdrawal period during which they received canakinumab 150 mg (2 mg/kg for patients ≤ 40 kg) s.c. or placebo every 8 weeks.
- III. dio: bolesnici koji su dovršili 16 tjedana liječenja i kategorizirani su kao bolesnici s odgovorom ponovno su bili randomizirani u 24-tjedno, dvostruko slijepo razdoblje ustezanja tijekom kojeg su primali kanakinumab 150 mg (2 mg/kg za bolesnike ≤40 kg) s.c. ili placebo svakih 8 tjedana.
The solution should be colourless or may have a slight brownish-yellow tint.
Otopina mora biti bezbojna ili imati blago smećkasto-žutu nijansu.
CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA): You should continue using Ilaris for as long as the doctor tells you.
CAPS, TRAPS, HIDS/MKD, FMF ili Stillova bolest (SBOD ili SJIA): trebate nastaviti primjenjivati Ilaris dokle god Vam to liječnik kaže.
UNIT PACK CARTON
KUTIJA JEDINIČNOG PAKIRANJA
Powder for solution for injection in a vial (type I glass) with a stopper (coated chlorobutyl rubber) and flip-off cap (aluminium).
Prašak za otopinu za injekciju u bočici (staklo tipa I) s čepom (obložena klorobutilna guma) i flip-off kapicom (aluminij).
Keep the needle all the way in the skin while slowly pushing the syringe plunger down until the barrel is empty.
Držite iglu do kraja u koži i lagano potiskujte klip štrcaljke prema dolje dok se tijelo štrcaljke ne isprazni.
Bioavailability in SJIA patients has not been determined independently.
Bioraspoloživost u bolesnika sa SJIA-om nije još neovisno utvrđena.
- Put the withdrawal needle on the syringe.
- Stavite iglu za izvlačenje na štrcaljku.
Overall, there were no clinically meaningful differences in the safety and tolerability profile of canakinumab in paediatric patients compared to the overall population.
Općenito nije bilo klinički značajnih razlika u profilu sigurnosti i podnošljivosti kanakinumaba u pedijatrijskih bolesnika u usporedbi s cjelokupnom populacijom.
By blocking the activity of IL-1 beta, Ilaris may improve these symptoms.
Blokiranjem aktivnosti IL-1 beta Ilaris može ublažiti te simptome.
Open the wrappers containing the syringe and the transfer needle (the 50 mm needle) and attach the needle to the syringe.
Otvorite omote u kojima su štrcaljka i igla za prijenos (igla od 50 mm) i pričvrstite iglu na štrcaljku.
Do not turn the vial and syringe upside down, the vial should stay upright.
Ne okrećite bočicu sa spojenom štrcaljkom naopako, bočica mora stajati uspravno.
Properly dispose of vials containing remaining Ilaris solution (if any) as directed by your healthcare provider or pharmacist.
Pravilno odložite bočice koje sadrže preostalu Ilaris otopinu (ako je ima) prema uputama zdravstvenog djelatnika ili ljekarnika.
Opportunistic infections have been reported in patients treated with canakinumab (see section 4.4).
Kod bolesnika liječenih kanakinumabom zabilježene su oportunističke infekcije (vidjeti dio 4.4).
In the overall SJIA programme, transient decreases in platelet counts (< LLN) were observed in 19 patients (9.5%).
U cjelokupnom programu za SJIA-u zabilježena su prolazna smanjenja broja trombocita (< DGN) u 19 bolesnika (9,5%).
- Do not use this medicine after the expiry date which is stated on the label and carton.
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
Gastrointestinal disorders Very common Upper abdominal pain Uncommon Gastro-oesophageal reflux disease Skin and subcutaneous tissue disorders Very common Injection site reaction Musculoskeletal and connective tissue disorders Very common Arthralgia Common
Poremećaji probavnog sustava vrlo često bol u gornjem dijelu abdomena manje često bolest gastroezofagealnog refluksa Poremećaji kože i potkožnog tkiva vrlo često reakcija na mjestu primjene injekcije Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često artralgija često mišićno-koštana bol bol u leđima Opći poremećaji i reakcije na mjestu primjene često umor/astenija
Based on the population pharmacokinetic modelling analysis, the pharmacokinetics of canakinumab in young adult SJIA patients aged 16 to 20 years were similar to those in patients less than 16 years of age.
Na temelju analize populacijskog farmakokinetičkog modeliranja, farmakokinetika kanakinumaba u mladih osoba sa SJIA-om u dobi od 16 do 20 godina bila je slična onoj u bolesnika mlađih od 16 godina.
Feeling weak or very tired (fatigue, asthenia).
Osjećaj slabosti ili jakog umora (umor, astenija).
If full treatment response is achieved, maintenance dose: 300 mg every 4 weeks
Ako se postigne potpuni odgovor na liječenje, doza održavanja: 300 mg svaka 4 tjedna
If you have not responded well enough to the treatment after 7 days, your doctor may give you another dose of 150 mg or 2 mg/kg.
Ako niste dovoljno dobro odgovorili na liječenje nakon 7 dana, liječnik Vam može dati još jednu dozu od 150 mg ili 2 mg/kg.
Ensure that the correct amount of solution is in the syringe.
Provjerite da je u štrcaljki odgovarajuća količina otopine.
Treatment with canakinumab induced a reduction of pain and reduced the risk of subsequent attacks in patients using ULT and unable to use both NSAIDs and colchicine, although the observed treatment difference compared to triamcinolone acetonide was less pronounced than with the overall study population.
Rezultati djelotvornosti za striktniju podskupinu ograničenu na aktualne korisnike ULT-a (N=62) prikazani su u Tablici 5. Liječenje kanakinumabom induciralo je smanjenje boli i smanjilo rizik od naknadnih napada kod bolesnika koji koriste ULT i koji ne mogu koristiti ni NSAIL-ove niti kolhicin, iako je uočena terapijska razlika u usporedbi s triamcinolon acetonidom bila manje izražena nego u cjelokupnoj ispitivanoj populaciji.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. Aktivne, teške infekcije (vidjeti dio 4.4).
Apparent clearance per kg body weight (CL/F per kg) was comparable between the gouty arthritis and CAPS population (0.004 l/d/kg).
Prividni klirens po kg tjelesne težine (CL/F po kg) bio je usporediv između populacije s uričnim artritisom i populacije s CAPS-om (0,004 l/d/kg).
Still's disease
Zloćudne bolesti
If a satisfactory clinical response has not been achieved 7 days after treatment start, a second dose of canakinumab at 150 mg or 2 mg/kg can be considered.
Ako se zadovoljavajući klinički odgovor ne postigne 7 dana nakon početka liječenja, može se razmotriti druga doza kanakinumaba od 150 mg ili 2 mg/kg.
Study G2301 was a randomised, double-blind, placebo-controlled withdrawal study of flare prevention by canakinumab.
Ispitivanje G2301 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje sprječavanja naglih pogoršanja kanakinumabom s fazom ustezanja aktivne terapije.
No impact on the type or frequency of adverse drug reactions was seen with longer-term treatment.
Nije bio uočen nikakav utjecaj na vrstu ili učestalost nuspojava na lijek pri dugotrajnom liječenju.
Pharmacokinetic properties are similar in CAPS, TRAPS, HIDS/MKD, FMF and SJIA paediatric populations.
Farmakokinetička svojstva slična su u pedijatrijskim populacijama s CAPS-om, TRAPS-om, HIDS/MKD-om, FMF-om i SJIA-om.
Avoid touching the needles and the tops of the vials.
Izbjegavajte dodirivanje igala i čepova bočica.
CAPS, TRAPS, HIDS/MKD and FMF
CAPS, TRAPS, HIDS/MKD i FMF
If full treatment response after 7 days, maintenance dose: 600 mg or 8 mg/kg every 8 weeks
Ako se javi potpuni odgovor na liječenje nakon 7 dana, doza održavanja: 600 mg ili 8 mg/kg svakih 8 tjedana
Open the wrappers containing the syringe and the withdrawal needle.
Otvorite omote koji sadrže štrcaljku i iglu za izvlačenje.
One was a safety, tolerability, and efficacy study of canakinumab in patients with CAPS.
Jedno je bilo ispitivanje sigurnosti, podnošljivosti i djelotvornosti kanakinumaba kod bolesnika s CAPS-om.
Resolution of the index disease flare was defined as having a Physician's Global Assessment (PGA) of Disease Activity score < 2 (“minimal or no disease”) and CRP within normal range (≤ 10 mg/l) or reduction ≥ 70% from baseline.
Physician's Global Assessment, PGA) od <2 („minimalna bolest ili bez bolesti“) i CRP unutar normalnog raspona (≤10 mg/l) ili smanjenje ≥70% u odnosu na početnu vrijednost.
5.2 Pharmacokinetic properties
5.2 Farmakokinetička svojstva CAPS
Treatment of gouty arthritis
Liječenje uričnog artritisa
Overall, there were no clinically meaningful differences in the efficacy, safety and tolerability profile of canakinumab in paediatric patients compared to the overall CAPS population.
Općenito nije bilo klinički relevantnih razlika u profilima djelotvornosti, sigurnosti i podnošljivosti kanakinumaba kod pedijatrijskih bolesnika u usporedbi s cjelokupnom populacijom oboljelih od CAPS-a.
Giving the injection
Davanje injekcije
Bioavailability in TRAPS, HIDS/MKD and FMF patients has not been determined independently.
Bioraspoloživost u bolesnika s TRAPS-om, HIDS/MKD-om i FMF-om nije neovisno utvrđena.
After reconstitution, each ml of solution contains 150 mg canakinumab.
Nakon rekonstitucije, svaki ml otopine sadrži 150 mg kanakinumaba.
- If you respond well enough to this, your treatment will be continued with 300 mg or 4 mg/kg every 4 weeks.
- Ako ste na to dovoljno dobro odgovorili, Vaše će se liječenje nastaviti s 300 mg ili 4 mg/kg svaka 4 tjedna.
• Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD),
Hyperimmunoglobulin D syndrome, HIDS)/nedostatka mevalonat kinaze (engl.
TRAPS, HIDS/MKD and FMF
TRAPS, HIDS/MKD i FMF
If a full treatment response is subsequently achieved, maintaining the intensified dosing regimen of 8 mg/kg every 8 weeks should be considered, based on individual clinical judgement.
Ako se naknadno postigne potpuni odgovor na liječenje, potrebno je razmotriti održavanje intenziviranog režima doziranja od 8 mg/kg svakih 8 tjedana, na temelju individualne kliničke procjene.
Pain in joints (arthralgia).
Bol u zglobovima (artralgija).
1 In SJIA
1 Kod SJIA-e
Laboratory abnormalities in TRAPS, HIDS/MKD and FMF patients Neutrophils
Laboratorijske abnormalnosti u bolesnika s TRAPS-om, HIDS/MKD-om i FMF-om Neutrofili
Ilaris has not been studied in patients with hepatic impairment.
Oštećenje jetre Ilaris nije bio ispitivan kod bolesnika s oštećenjem jetre.
Very common Respiratory tract infections (including pneumonia, bronchitis, influenza, viral infection, sinusitis, rhinitis, pharyngitis, tonsillitis, nasopharyngitis, upper respiratory tract infection)
Infekcije i infestacije vrlo često infekcije dišnog sustava (uključujući pneumoniju, bronhitis, gripu, virusnu infekciju, sinusitis, rinitis, faringitis, tonzilitis, nazofaringitis, infekciju gornjeg dijela dišnog sustava) infekcija uha celulitis gastroenteritis infekcija mokraćnog sustava često vulvovaginalna kandidijaza Poremećaji živčanog sustava često omaglica/vrtoglavica
Continued treatment with canakinumab in patients without clinical improvement should be reconsidered by the treating physician.
Liječnik mora ponovno razmotriti nastavak liječenja kanakinumabom u bolesnika bez kliničkog poboljšanja.
Secondary endpoints (disease and inflammatory markers)
Sekudnarne mjere ishoda (markeri bolesti i upale)
If full treatment response is achieved, maintenance dose: 4 mg/kg every 4 weeks
Ako se postigne potpuni odgovor na liječenje, doza održavanja: 4 mg/kg svaka 4 tjedna
Ilaris is injected every 4 weeks as a single dose.
Svaka 4 tjedna ubrizgava se jedna doza Ilarisa .
- Part II: Patients at flare onset were randomised into a 16-week double-blind, placebo-controlled treatment period during which they received either 150 mg canakinumab (2 mg/kg for patients with body weight ≤ 40 kg) subcutaneous (s.c.) or placebo every 4 weeks.
- II. dio: bolesnici su kod nastupa razbuktavanja bolesti bili randomizirani u 16-tjedno dvostruko slijepo, placebom kontrolirano razdoblje liječenja tijekom kojeg su primali ili 150 mg kanakinumaba (2 mg/kg za bolesnike tjelesne težine ≤40 kg) supkutano (s.c.) ili placebo svaka 4 tjedna.
Gently push the plunger all the way down until all of the air is injected into the vial.
Lagano gurnite klip do kraja dok se sav zrak ne ubrizga u bočicu.
The solution should be free of visible particles and clear to opalescent.
Otopina treba biti bez vidljivih čestica i bistra do opalescentna.
The solution is clear to opalescent and colourless to slightly brownish yellow.
Otopina je bistra do opalescentna i bezbojna do blago smećkasto-žuta.
Take off the protective cap from the Ilaris vial.
Uklonite zaštinu kapicu s bočice Ilarisa.
Remove the transfer needle from the syringe.
Maknite iglu za prijenos sa štrcaljke.
Additional dose of 150 mg or 2 mg/kg can be considered
Može se razmotriti dodatna doza od 150 mg ili 2 mg/kg
Table 2 Tabulated summary of efficacy in Phase III trial, pivotal placebo-controlled withdrawal period (Part II)
Tablica 2 Tablični sažetak djelotvornosti u ispitivanju faze III, ključno placebom kontrolirano razdoblje ustezanja (II. dio)
Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).
Ilaris je indiciran za liječenje periodičnog sindroma povezanog s receptorom faktora nekroze tumora (engl. tumour necrosis factor, TNF)(TRAPS).
Carefully remove the cap from the transfer needle and set the cap aside.
Pažljivo uklonite kapicu s igle za prijenos i stavite je sa strane.
- The solution should be used immediately after first piercing the vial stopper to prepare the injection.
- Nakon što ste proboli čep bočice, otopinu je potrebno odmah upotrijebiti za pripremu injekcije.
Safely dispose of needles and syringe in the sharps container or as directed by your healthcare provider or pharmacist.
Sigurno odložite igle i štrcaljku u spremnik za oštre predmete ili prema uputama zdravstvenog djelatnika ili ljekarnika.
If a full treatment response is subsequently achieved, maintaining the intensified dosing regimen of 600 mg or 8 mg/kg every 8 weeks should be considered, based on individual clinical judgement.
Ako se naknadno postigne potpuni odgovor na liječenje, potrebno je razmotriti održavanje intenziviranog režima doziranja od 600 mg ili 8 mg/kg svakih 8 tjedana, na temelju individualne kliničke procjene.
Maintenance dose: 300 mg or 4 mg/kg every 8 weeks
Doza održavanja: 300 mg ili 4 mg/kg svakih 8 tjedana
Gather together the necessary items Included in the pack - one vial of Ilaris powder for solution for injection (keep refrigerated)
Uključeno u pakiranje jedna bočica Ilaris praška za otopinu za injekciju (čuvati u hladnjaku)