natgillin/translations-raw huggingface dataset:
Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1).
Ilaris je indiciran za simptomatsko liječenje odraslih bolesnika s učestalim napadima uričnog artritisa (najmanje 3 napada u proteklih 12 mjeseci) u kojih su nesteroidni antiinflamatorni lijekovi (NSAIL) i kolhicin kontraindicirani, bolesnici ih ne podnose, ili ne omogućuju odgovarajući odgovor te u kojih ponavljani ciklusi kortikosteroida nisu primjenjivi (vidjeti dio 5.1).
Phase III trial, pivotal placebo-controlled withdrawal period (Part II) Canakinumab N=15 n(%)
Ispitivanje faze III, ključno placebom kontrolirano razdoblje ustezanja (II. dio) Kanakinumab N=15 n(%)
Ilaris can be given as monotherapy or in combination with methotrexate.
Ilaris se može davati kao monoterapija ili u kombinaciji s metotreksatom.
The safety and efficacy of Ilaris in CAPS, TRAPS, HIDS/MKD and FMF patients under 2 years of age have not been established.
Sigurnost i djelotvornost Ilarisa u bolesnika s CAPS-om, TRAPS-om, HIDS/MKD-om i FMF-om mlađih od 2 godine nije ustanovljena.
Instructions for use of Ilaris solution for injection
Upute za uporabu Ilaris otopine za injekciju
All indications: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, gouty arthritis
Sve indikacije: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, urični artritis
In Part II of the study, patients treated with canakinumab who had persistent disease activity received an additional dose of 150 mg (or 2 mg/kg for patients ≤ 40 kg) within the first month.
U II. dijelu ispitivanja, bolesnici liječeni kanakinumabom koji su imali perzistentnu aktivnost bolesti primili su dodatnu dozu od 150 mg (ili 2 mg/kg za bolesnike ≤40 kg) unutar prvog mjeseca.
Study G2301
Ispitivanje G2301
Patients must be monitored closely for signs and symptoms of tuberculosis during and after treatment with canakinumab.
Bolesnike je potrebno pažljivo nadzirati zbog mogućih znakova i simptoma tuberkuloze tijekom i nakon liječenja kanakinumabom.
Treatment of CAPS, TRAPS, HIDS/MKD, FMF and Still's disease (AOSD and SJIA) Canakinumab should not be initiated or continued in patients during an active infection requiring medical intervention.
Liječenje CAPS-a, TRAPS-a, HIDS/MKD-a, FMF-a i Stillove bolesti (SBOD i SJIA) Liječenje kanakinumabom ne smije se započeti ili nastaviti kod bolesnika tijekom aktivne infekcije koja zahtijeva medicinsku intervenciju.
Your doctor will monitor you for potential triggering factors of MAS that include infections and re-activation of the underlying Still's disease (flare).
Vaše stanje radi čimbenika koji su mogući okidači sindroma aktivacije makrofaga a uključuju infekcije i ponovnu aktivaciju osnovne Stillove bolesti (naglo pogoršanje).
Dispose of the needle and syringe in the sharps container without recapping or removing the needle.
Odložite iglu i štrcaljku u spremnik za oštre predmete bez vraćanja kapice ili vađenja igle.
If you do not respond well enough to the second dose, a third dose of Ilaris at 300 mg or 4 mg/kg may be given.
Ako ne odgovorite dovoljno dobro na drugu dozu, može Vam se dati treća doza Ilarisa od 300 mg ili 4 mg/kg.
CAPS, TRAPS, HIDS/MKD, FMF and SJIA: Ilaris can be used in children aged 2 years and older.
CAPS, TRAPS, HIDS/MKD, FMF i SJIA: Ilaris se može koristiti u djece u dobi od 2 i više godina.
Decreases in absolute neutrophil counts (ANC) to less than 1 x 10
Smanjenje apsolutnog broja neutrofila (ABN) na manje od 1 x 10
The second patient received a starting dose of canakinumab 2 mg/kg and an add-on dose of 2 mg/kg at week 3, and was up-titrated at week 5 to receive a dose of 4 mg/kg administered every 4 weeks until the end of Part II of the study.
Drugi je bolesnik primio početnu dozu kanakinumaba od 2 mg/kg i dodatnu dozu od 2 mg/kg u 3. tjednu, te mu je doza postupno povećana u 5. tjednu da bi primao dozu od 4 mg/kg koja se primjenjuje svaka 4 tjedna do kraja II. dijela ispitivanja.
Drop in level of blood cells which help prevent bleeding (platelets).
Smanjenje razine krvnih stanica koje pomažu spriječiti krvarenje (trombocita).
Decreased white blood cell counts (WBC) ≤ 0.8 x lower limit of normal (LLN) were reported in 6.7% of patients treated with canakinumab compared to 1.4% treated with triamcinolone acetonide.
Smanjene razine leukocita (Lkc) ≤0,8 x donje granice normale (DGN) zabilježeno je kod 6,7% bolesnika liječenih kanakinumabom u usporedbi s 1,4% liječenih triamcinolon acetonidom.
Study G2306 was an open-label study to assess maintenance of treatment response with canakinumab dose reduction (2 mg/kg every 4 weeks) or dose interval prolongation (4 mg/kg every 8 weeks) in SJIA patients who were receiving canakinumab 4 mg/kg every 4 weeks.
Ispitivanje G2306 bilo je otvoreno ispitivanje za ocjenjivanje održavanja odgovora na liječenje sa smanjenjem doze kanakinumaba (2 mg/kg svaka 4 tjedna) ili produljenjem intervala doziranja (4 mg/kg svakih 8 tjedana) u bolesnika sa SJIA-om koji su primali kanakinumab 4 mg/kg svaka 4 tjedna.
Maintenance dose: 150 mg every 4 weeks
Doza održavanja: 150 mg svaka 4 tjedna
There were 102 TRAPS, HIDS/MKD and FMF patients (2-17 years of age) who received canakinumab in a 16-week study.
Bilo je 102 bolesnika oboljelih od TRAPS-a, HIDS/MKD-a i FMF-a (dob 2-17 godina) koji su primali kanakinumab u 16-tjednom ispitivanju.
Let the vial stand unopened for 10 minutes to bring the contents to room temperature.
Pustite da bočica odstoji 10 minuta neotvorena kako bi poprimila sobnu temperaturu.
Following canakinumab treatment, the inflammatory markers CRP or SAA and signs of acute inflammation (e.g. pain, swelling, redness) in the affected joint subside rapidly.
Nakon liječenja kanakinumabom upalni markeri CRP ili SAA i znakovi akutne upale (npr. bol, oticanje, crvenilo) u zahvaćenom zglobu brzo se povlače.
If not used immediately after reconstitution, the solution should be kept at 2°C to 8°C and used within 24 hours.
Ako se ne upotrijebi odmah nakon rekonstitucije, otopinu valja čuvati na temperaturi od 2°C do 8°C i upotrijebiti u roku od 24 sata.
In Part I (open label) 177 patients were enrolled and received 4 mg/kg (up to 300 mg) canakinumab administered every 4 weeks for up to 32 weeks.
U prvi dio (otvoreni), bilo je uključeno 177 bolesnika koji su primali 4 mg/kg (do 300 mg) kanakinumaba primijenjenog svaka 4 tjedna u trajanju do 32 tjedna.
Not included in the pack one vial (or ampoule) of sterile water for injections (“water”) (at room temperature) one 1.0 ml syringe one 18 G x 2 inch (50 mm) needle for reconstituting the powder (“transfer needle”) one 27 G x 0.5 inch (13 mm) needle for injecting (“injection needle”) alcohol swabs clean, dry cotton swabs an adhesive plaster a proper disposal container for used needles, syringe and vials (sharps container)
Nije uključeno u pakiranje jedna bočica (ili ampula) sterilne vode za injekcije („voda“) (na sobnoj temperaturi) jedna štrcaljka od 1,0 ml jedna igla 18 G x 50 mm za pripremu praška („igla za prijenos“) jedna igla 27 G x 13 mm za injekciju („igla za injekciju“) jastučići natopljeni alkoholom čisti, suhi pamučni jastučići ljepljivi flaster odgovarajući spremnik za odlaganje upotrijebljenih igala, štrcaljki i bočica (spremnik za oštre predmete).
The following are suitable injection sites: upper thigh, abdomen, upper arm or buttocks.
Sljedeća su mjesta prikladna za injekciju: gornji dio bedara, abdomen, nadlaktica ili stražnjica.
Clean the rubber stopper of the vial containing the Ilaris solution with a new alcohol swab.
Očistite gumeni čep bočice koja sadrži otopinu Ilarisa novim jastučićem natopljenim alkoholom.
Predicted steady-state exposure values (Cmin,ss, Cmax,ss, AUC,ss,8w) after 150 mg subcutaneous administration (or 2 mg/kg, respectively) every 8 weeks were slightly higher in the weight category 40-70 kg (6.6 µg/ml, 24.3 µg/ml, 767 µg*d/ml) compared to the weight categories < 40 kg (4.0 µg/ml, 19.9 µg/ml, 566 µg*d/ml) and > 70 kg (4.6 µg/ml, 17.8 µg/ml, 545 µg*d/ml).
Predviđene vrijednosti izloženosti u stanju dinamičke ravnoteže (Cmin,ss, Cmax,ss, AUC,ss,8w) nakon supkutane primjene 150 mg (odnosno 2 mg/kg) svakih 8 tjedana bile su nešto više u kategoriji tjelesne težine od 40-70 kg (6,6 µg/ml, 24,3 µg/ml, 767 µg*d/ml) u usporedbi s kategorijama težine od < 40 kg (4,0 µg/ml, 19,9 µg/ml, 566 µg*d/ml) i > 70 kg (4,6 µg/ml, 17,8 µg/ml, 545 µg*d/ml).
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).
Srednja promjena u bolesnikovim rezultatima za bol (vizualna analogna skala 0-100 mm) nakon 15 dana bila je -50,0 mm za kanakinumab (N=43), u usporedbi s +4,5 mm za placebo (N=25).
Study G2305
Ispitivanje G2305
The primary objective was the proportion of patients at day 15 who achieved a minimum 30% improvement in the paediatric American College of Rheumatology (ACR) response criterion adapted to include absence of fever.
Primarni cilj bio je udio bolesnika 15. dana koji su postigli poboljšanje od najmanje 30% u odgovoru prema kriterijima Američkog društva za reumatologiju (engl.
Mean values for Cmax and AUCinf after a single subcutaneous dose of 150 mg in a typical adult CAPS patient (70 kg) were 15.9 µg/ml and 708 µg*d/ml.
Srednje vrijednosti za Cmax i AUCinf nakon jednokratne supkutane doze od 150 mg kod tipičnog odraslog bolesnika s CAPS-om (70 kg) bile su 15,9 µg/ml i 708 µg*d/ml.
Patients in Part II (double-blind) received either canakinumab 4 mg/kg or placebo every 4 weeks until 37 flare events occurred.
Bolesnici u drugom dijelu (dvostruko slijepom) primali su ili kanakinumab 4 mg/kg ili placebo svaka 4 tjedna dok se nije dogodilo 37 događaja razbuktavanja bolesti.
Once the required volume is withdrawn, recap and remove the withdrawal needle from the syringe and attach a 27 G x 0.5 inch needle (or similar as available on the market) to immediately inject the solution subcutaneously.
Nakon što izvučete potreban volumen, vratite poklopac i uklonite iglu za izvlačenje sa štrcaljke te pričvrstite iglu od 27 G x 13 mm (ili sličnu, ovisno o tome što je dostupno na tržištu) da biste odmah supkutano ubrizgali otopinu.
A 56-week, open-label study was conducted to assess the efficacy, safety and tolerability of canakinumab in paediatric CAPS patients ≤ 4 years of age.
Provedeno je 56-tjedno, otvoreno ispitivanje da bi se ocijenila djelotvornost, sigurnost i podnošljivost kanakinumaba u pedijatrijskih bolesnika s CAPS-om u dobi od ≤4 godine.
Adult-onset Still's disease and systemic juvenile idiopathic arthritis are severe autoinflammatory diseases, driven by innate immunity by means of pro-inflammatory cytokines, a key one being IL-1beta.
Stillova bolest odrasle dobi i sistemski juvenilni idiopatski artritis teške su autoinflamatorne bolesti, koje potiče prirođeni imunitet pomoću proinflamatornih citokina, od kojih je ključni IL-1-beta.
Do not touch the needles or the top of the vial.
Ne dodirujte igle ili čep bočice.
• Respiratory infections such as chest infection, flu, sore throat, runny nose, blocked nose, sneezing, feeling of pressure or pain in the cheeks or forehead with or without fever (pneumonia, bronchitis, influenza, sinusitis, rhinitis, pharyngitis, tonsilitis, nasopharyngitis, upper respiratory tract infection).
• Respiratorne infekcije kao što su infekcija dišnih puteva, gripa, grlobolja, curenje nosa, začepljen nos, kihanje, osjećaj pritiska ili boli u obrazima ili čelu s vrućicom ili bez nje (pneumonija, bronhitis, influenca, sinusitis, rinitis, faringitis, tonzilitis, nazofaringitis, infekcija gornjeg dijela dišnog sustava).
It is unknown whether canakinumab is excreted in human milk.
Nije poznato izlučuje li se kanakinumab u majčino mlijeko u ljudi.
Predicted canakinumab steady state exposures at a dose level of 4 mg/kg (maximum 300 mg) in patients over the age of 20 years were comparable to those in SJIA patients younger than 20 years of age.
Predviđeno izlaganje kanakinumabu u stanju dinamičke ravnoteže pri doziranju od 4 mg/kg (maksimum 300 mg) u bolesnika starijih od 20 godina bilo je usporedivo s onim u bolesnika sa SJIA-om mlađih od 20 godina.
For CAPS, TRAPS, HIDS/MKD, FMF and Still's disease, the treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of the relevant indication.
Za CAPS, TRAPS, HIDS/MKD, FMF i Stillovu bolest, liječenje mora započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju relevantne indikacije.
Ilaris blocks the activity of IL-1 beta, which may improve the signs and symptoms of Still's disease.
Ilaris blokira aktivnosti IL-1 beta, što može ublažiti znakove i simptome Stillove bolesti.
In the overall SJIA programme, transient decreased white blood cell (WBC) counts ≤ 0.8 x LLN were reported in 33 patients (16.5%).
U cjelokupnom programu za SJIA-u prolazno snižene razine broja leukocita (Lkc) ≤ 0,8 x DGN bile su zabilježene u 33 bolesnika (16,5%).
Slowly pull the syringe plunger up to the correct mark (amount to be given as per healthcare provider's instructions), filling the syringe with Ilaris solution.
Polako povucite klip štrcaljke do odgovarajuće oznake (za količinu koja će se primijeniti prema uputama zdravstvenog djelatnika), tako da se štrcaljka napuni Ilaris otopinom.
- Still's disease including adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) - Gouty arthritis
- Stillova bolest uključujući Stillovu bolest odrasle dobi (SBOD) i sistemski juvenilni idiopatski artritis (SJIA) - urični artritis
One patient had resolution of index flare by day 15 after receiving one single dose of canakinumab 2 mg/kg, but discontinued treatment after this first dose due to serious adverse events (pancytopenia and hepatic failure).
U jednog se bolesnika razbuktavanje osnovne bolesti povuklo do 15. dana nakon jednokratne doze kanakinumaba od 2 mg/kg, ali bolesnik je prekinuo liječenje nakon te prve doze zbog ozbiljnih nuspojava (pancitopenija i zatajenje jetre).
Overall, there were no clinically meaningful differences in the safety and tolerability profile of canakinumab in paediatric patients compared to the overall CAPS population (comprised of adult and paediatric patients, N=211), including the overall frequency and severity of infectious episodes.
Općenito nije bilo klinički relevantnih razlika u profilu sigurnosti i podnošljivosti kanakinumaba kod pedijatrijskih bolesnika u usporedbi s cjelokupnom populacijom bolesnika s CAPS-om (koju čine odrasli i pedijatrijski bolesnici, N=211), što uključuje cjelokupnu učestalost i težinu infektivnih epizoda.
This is administered every four weeks as a single dose via subcutaneous injection.
Jedna doza se primjenjuje svaka četiri tjedna kao supkutana injekcija.
Study G2305 was a randomised, double-blind, placebo-controlled, 4-week study assessing the shortterm efficacy of canakinumab in 84 patients randomised to receive a single dose of 4 mg/kg (up to 300 mg) canakinumab or placebo.
Ispitivanje G2305 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano, 4-tjedno ispitivanje kojim se ocjenjivala kratkoročna djelotvornost kanakinumaba u 84 bolesnika randomiziranih na primanje jednokratne doze od 4 mg/kg (do 300 mg) kanakinumaba ili placeba.
No dose adjustment is needed in patients with renal impairment.
Nije potrebno prilagođavati dozu kod bolesnika s oštećenjem bubrega.
TRAPS n=number of responders; N=number of evaluable patients * indicates statistical significance (one-sided) at the 0.025 level based on Fisher exact test **Indicates statistical significance (one-sided) at the 0.025 level based on the logistic regression model with treatment group and baseline PGA, CRP or SAA respectively, as explanatory variables for each cohort
TRAPS n=broj bolesnika s odgovorom; N=broj bolesnika koje je bilo moguće ocijeniti * označava statističku značajnost (jednostrano) pri 0,025 na temelju Fisherovog egzaktnog testa ** označava statističku značajnost (jednostrano) pri 0,025 na temelju modela logističke regresije s terapijskom skupinom odnosno početnim PGA-om, CRP-om ili SAA-om, kao eksplanatornim varijablama za svaku kohortu
What Ilaris is
Što je Ilaris
Ilaris treatment may give you a spinning sensation (dizziness or vertigo) or intense tiredness (asthenia).
Liječenje Ilarisom može Vam uzrokovati osjećaj vrtnje (omaglica ili vrtoglavica) ili intenzivan umor (asteniju).
The peak serum canakinumab concentration (Cmax) occurred approximately 7 days following single subcutaneous administration of 150 mg in adult CAPS patients.
Do vršne koncentracije kanakinumaba u serumu (Cmax) došlo je otprilike 7 dana nakon jednokratne supkutane primjene 150 mg u odraslih bolesnika s CAPS-om.
Unable to use both NSAIDs and colchicine; on ULT N=62 Treatment of gouty arthritis attacks as measured by pain intensity (VAS) at 72 h Least Squares mean estimated difference to triamcinolone acetonide CI p-value, 1-sided p < 0.0001*
Ne mogu koristiti ni NSAILove niti kolhicin; na ULT-u N=62 Liječenje napada uričnog artritisa mjereno intenzitetom boli (VAS) nakon 72 h Srednja vrijednost razlike procijenjena metodom najmanjih kvadrata u odnosu na triamcinolon acetonid CI p-vrijednost, jednostrana p<0,0001*
How long to use Ilaris
Koliko dugo primjenjivati Ilaris
150 mg or 2 mg/kg
150 mg ili 2 mg/kg
The solution is a clear to opalescent liquid.
Otopina je bistra do opalescentna tekućina.
Slowly pull the syringe plunger up to the correct mark (amount to be given), filling the syringe with Ilaris solution.
Polako povucite klip štrcaljke do odgovarajuće oznake (za količinu koju treba primijeniti), tako da se štrcaljka napuni Ilaris otopinom.
Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during canakinumab treatment.
Tijekom liječenja kanakinumabom zabilježeni su izolirani slučajevi neuobičajenih ili oportunističkih infekcija (uključujući aspergilozu, atipične mikobakterijske infekcije, herpes zoster).
Read these instructions all the way through before beginning.
Prije nego počnete pročitajte u cijelosti ove upute.
Candida - vaginal yeast infection (vulvovaginal candidiasis).
Gljivična infekcija rodnice kandidom (vulvovaginalna kandidijaza).
A pro-inflammatory protein called IL-1 beta plays an important role in Still's disease inflammation.
Proinflamatorni protein koji se zove IL-1 beta igra važnu ulogu u upalnim procesima kod Stillove bolesti.
After repeated administration of 4 mg/kg every 4 weeks the accumulation ratio of canakinumab was 1.6 fold in SJIA patients.
Nakon opetovane primjene 4 mg/kg svaka 4 tjedna omjer akumulacije kanakinumaba bio je 1,6 puta veći u bolesnika sa SJIA-om.
Triglycerides
Trigliceridi
Women should use effective contraceptives during treatment with canakinumab and for up to 3 months after the last dose.
Žene reproduktivne dobi / Kontracepcija u muškaraca i žena Žene moraju koristiti učinkovitu kontracepciju tijekom liječenja kanakinumabom te do 3 mjeseca nakon posljednje doze.
Therefore patients should be monitored carefully for signs and symptoms of infections during and after treatment with canakinumab.
Stoga kod bolesnika valja pozorno pratiti moguću pojavu znakova i simptoma infekcije tijekom i nakon liječenja kanakinumabom.
If you stop using Ilaris
Ako prestanete primjenjivati Ilaris
2 In gouty arthritis
2 Kod uričnog artritisa
Hypersensitivity reactions with canakinumab therapy have been reported.
Zabilježene su reakcije preosjetljivosti tijekom terapije kanakinumabom.
The recommended dose of Ilaris for adult gouty arthritis patients is 150 mg given as a single dose at the time of a gouty arthritis attack.
Preporučena doza Ilarisa za odrasle bolesnike s uričnim artritisom je 150 mg i daje se kao jednokratna doza u vrijeme napada uričnog artritisa.
An additional pharmacokinetics analysis showed that the pharmacokinetics of canakinumab in 6 paediatric CAPS patients under the age of 2 years were similar to the pharmacokinetics in paediatric patients 2-4 years of age.
Dodatna farmakokinetička analiza pokazala je da je farmakokinetika kanakinumaba u 6 pedijatrijskih bolesnika s CAPS-om mlađih od 2 godine bila slična farmakokinetici u pedijatrijskih bolesnika u dobi od 2-4 godine.
Injecting Ilaris yourself or injecting a patient with Ilaris If you are a patient with CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA), or a caregiver of a patient with one of these conditions, you may administer Ilaris injections yourself after proper training in the correct injection technique.
Ako sami sebi ili bolesniku dajete injekciju Ilarisa Ako ste bolesnik koji ima CAPS, TRAPS, HIDS/MKD, FMF ili Stillovu bolest (SBOD ili SJIA), ili osoba koja njeguje bolesnika s jednim od navedenih stanja, možete sami primijeniti injekcije Ilarisa nakon odgovarajuće obuke iz pravilne tehnike davanja injekcije.
Peak concentrations of canakinumab occurred between 2 to 7 days (Tmax) following single subcutaneous administration of canakinumab 150 mg or 2 mg/kg in paediatric patients 4 years of age and older.
Vršne koncentracije kanakinumaba javile su se između 2 do 7 dana (Tmax) nakon jednokratne supkutane primjene kanakinumaba 150 mg ili 2 mg/kg kod pedijatrijskih bolesnika u dobi od 4 godine i više.
Phase III trial, pivotal, randomised placebo-controlled treatment period (Part II) Canakinumab n/N (%)
Ispitivanje faze III, ključno, randomizirano, placebom kontrolirano razdoblje liječenja (II. dio) Kanakinumab n/N (%)
Remove the withdrawal needle from the syringe and place it in the sharps container.
Maknite iglu za izvlačenje sa štrcaljke i odložite ju u spremnik za oštre predmete.
The primary efficacy endpoint of the randomised treatment period (Part II) was the proportion of responders within each cohort who had resolution of their index disease flare at day 15 and did not experience a new flare during the remainder of the 16-week treatment period (defined as complete response).
Primarna mjera djelotvornosti u randomiziranom razdoblju liječenja (II. dio) bila je udio bolesnika s odgovorom u svakoj kohorti u kojih se povuklo razbuktavanje osnovne bolesti do 15. dana i u kojih nije došlo do ponovnog razbuktavanja tijekom ostatka 16-tjednog razdoblja liječenja (definirano kao potpuni odgovor).
Slowly inject the water into the vial containing the Ilaris powder.
Polako ubrizgajte vodu u bočicu s Ilaris praškom.
Bioavailability in gouty arthritis patients has not been determined independently.
Bioraspoloživost kod bolesnika s uričnim artritisom nije još neovisno utvrđena.
This is administered every eight weeks as a single dose via subcutaneous injection.
Jedna doza se primjenjuje svakih osam tjedana kao supkutana injekcija.
Mean exposure in a typical gouty arthritis patient (93 kg) after a single subcutaneous 150 mg dose (Cmax: 10.8 µg/ml and AUCinf: 495 µg*d/ml) was lower than in a typical 70 kg CAPS patient (15.9 µg/ml and 708 µg*d/ml).
Srednja izloženost kod tipičnog bolesnika s uričnim artritisom (93 kg) nakon jednokratne supkutane doze od 150 mg (Cmax: 10,8 µg/ml i AUCinf: 495 µg*d/ml) bila je niža nego kod tipičnog bolesnika s CAPS-om težine od 70 kg (15,9 µg/ml i 708 µg*d/ml).
Open the wrapper containing the injection needle and attach the needle to the syringe.
Otvorite omot koji sadrži iglu za injekciju i pričvrstite iglu na štrcaljku.
The expected accumulation ratio was 1.3-fold following 6 months of subcutaneous administration of 150 mg canakinumab every 8 weeks.
Očekivani omjer akumulacije bio je 1,3 puta veći nakon 6 mjeseci supkutane primjene 150 mg kanakinumaba svakih 8 tjedana.
If you see bubbles in the syringe, remove bubbles as instructed by your healthcare professional or pharmacist.
Ako vidite mjehuriće u štrcaljki, uklonite mjehuriće prema uputama zdravstvenog radnika ili ljekarnika.
Hypersensitivity reactions have been reported in patients treated with canakinumab (see sections 4.3 and 4.4).
Kod bolesnika liječenih kanakinumabom zabilježene su reakcije preosjetljivosti (vidjeti dio 4.3 i 4.4).
If you forget to use Ilaris
Ako ste zaboravili primijeniti Ilaris