natgillin/translations-raw huggingface dataset:
In the long-term, open-label studies with dose escalation, events of infections (gastroenteritis, respiratory tract infection, upper respiratory tract infection), vomiting and dizziness were more frequently reported in the 600 mg or 8 mg/kg dose group than in other dose groups.
U dugoročnim, otvorenim ispitivanjima s eskalacijom doze pojave infekcija (gastroenteritis, infekcija dišnog sustava, infekcija gornjeg dijela dišnog sustava), povraćanja i omaglice bile su češće u skupini koja je primala dozu od 600 mg ili 8 mg/kg nego u ostalim doznim skupinama.
What Ilaris contains
Što Ilaris sadrži
The aim of the study was to assess efficacy, safety, and tolerability of canakinumab (150 mg or 2 mg/kg every 8 weeks) in patients with CAPS.
Cilj ispitivanja bio je ocijeniti djelotvornost, sigurnost i podnošljivost kanakinumaba (150 mg ili 2 mg/kg svakih 8 tjedana) kod bolesnika s CAPS-om.
The safety and efficacy of Ilaris in SJIA patients under 2 years of age have not been established.
Sigurnost i djelotvornost Ilarisa u bolesnika sa SJIA-om mlađih od 2 godine nije ustanovljena.
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.
Nakon 24 tjedna, 71% (27/38) bolesnika koji su primali smanjenu dozu (2 mg/kg svaka 4 tjedna) i 84% (31/37) bolesnika koji su imali produljeni interval doziranja (4 mg/kg svakih 8 tjedana) uspjelo je održati status neaktivne bolesti 6 mjeseci.
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.
U kliničkim ispitivanjima bolesnici s CAPS-om, TRAPS-om, HIDS/MKD-om i FMF-om koji imaju nekontrolirano prekomjerno stvaranje IL-1 beta pokazuju brzi i održani odgovor na terapiju kanakinumabom, tj. povratak na normalne vrijednosti laboratorijskih parametara poput C-reaktivnog proteina (CRP) i serumskog amiloida A (SAA), visokog broja neutrofila i trombocita te leukocitoze.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti u skladu s lokalnim propisima.
If you received canakinumab while you were pregnant, it is important that you inform the baby's doctor or nurse before any vaccinations are given to your baby.
Ako ste primili kanakinumab tijekom trudnoće, važno je da o tome obavijestite djetetovog liječnika ili medicinsku sestru prije nego
Other activators of the innate immune system, such as endogenous agonists of toll-like receptors, may contribute to the transcriptional activation of the IL1 beta gene, initiating a gouty arthritis attack.
Drugi aktivatori prirođenog imunološkog sustava, kao što su endogeni agonisti receptora sličnih Tollu, mogu doprinijeti transkripcijskoj aktivaciji IL-1 beta gena te započeti napad uričnog artritisa.
Live vaccines: You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while you are being treated with Ilaris.
Živa cjepiva: preporučuje se da izjegavate cijepljenje vrstom cjepiva koje se naziva živim cjepivom dok se liječite Ilarisom.
• Patient Reminder Card
• Kartica s podsjetnikom za bolesnika
Antibodies against Ilaris were observed in approximately 1.5%, 3% and 2% of the patients treated with Ilaris for CAPS, SJIA and gouty arthritis, respectively.
Protutijela protiv Ilarisa uočena su u otprilike 1,5%, 3% i 2% bolesnika liječenih Ilarisom zbog CAPSa, SJIA te u 2% bolesnika liječenih Ilarisom zbog uričnog artritisa.
Macrophage activation syndrome in patients with Still's disease
Sindrom aktivacije makrofaga u bolesnika sa Stillovom bolešću
Periodic fever syndromes Ilaris is used in adults and children aged 2 years and older to treat the following: - Cryopyrin-associated periodic syndromes (CAPS) - this is a group of auto-inflammatory diseases, which include:
Ilaris se primjenjuje u odraslih osoba i djece u dobi od 2 i više godina za liječenje sljedećeg: periodičnih sindroma povezanih s kriopirinom (CAPS) - to je skupina autoinflamatornih bolesti koja uključuje:
Abnormal kidney function test results (creatinine renal clearance decreased, proteinuria).
Poremećeni rezultati testa bubrežne funkcije (smanjeni bubrežni klirens kreatinina, proteinurija).
In a subset of young adult SJIA patients aged 16 to 20 years (n=31), the safety profile of canakinumab was consistent with what was observed in SJIA patients less than 16 years of age.
U podskupini mladih bolesnika sa SJIA-om u dobi od 16 do 20 godina (n=31), sigurnosni profil kanakinumaba bio je u skladu s onim što je zabilježeno u bolesnika sa SJIA-om mlađih od 16 godina.
Immediately proceed to administering the injection.
Odmah nastavite s primjenom injekcije.
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).
Sekundarne mjere ishoda, sve temeljene na rezultatima iz 16. tjedna (kraj II. dijela), uključivale su udio bolesnika koji su postigli PGA od <2, udio bolesnika sa serološkom remisijom (definirano kao CRP ≤10 mg/l) te udio bolesnika s normaliziranom razinom SAA (definirano kao SAA ≤10 mg/l).
The CAPS interventional trials with canakinumab included a total of 80 paediatric patients with an age range from 2 to 17 years (approximately half of them treated on an mg/kg basis).
Intervencijska ispitivanja CAPS-a s kanakinumabom uključivala su ukupno 80 pedijatrijskih bolesnika u dobi od 2 do 17 godina (otprilike polovica njih bila je liječena na temelju mg/kg).
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.
Koristeći iglu od 18 G ili 21 G x 50 mm (ili sličnu, ovisno o tome što je dostupno na tržištu) i štrcaljku od 1 ml, pažljivo izvucite potreban volumen ovisno o dozi koja se primjenjuje.
Patients on urate lowering therapy (ULT)
Bolesici na terapiji za snižavanje urata (ULT)
Patients with Still's disease may develop a condition called macrophage activation syndrome (MAS), which can be life-threatening.
U bolesnika sa Stillovom bolešću može se razviti stanje koje se naziva sindrom aktivacije makrofaga, a koje može biti opasno po život.
The rate of adverse events in both treatment arms was similar to the rate seen in patients treated with canakinumab 4 mg/kg every 4 weeks.
Stopa štetnih događaja u obje skupine liječenja bila je slična stopi u bolesnika liječenih kanakinumabom u dozi od 4 mg/kg svaka 4 tjedna.
Mean and median increases in alanine transaminase (ALT) of 3.0 U/l and 2.0 U/l, respectively, and in aspartate transaminase (AST) of 2.7 U/l and 2.0 U/l, respectively, from baseline to end of study were seen in the canakinumab-treated groups versus the triamcinolone acetonide-treated group(s), however the incidence of clinically significant changes (≥ 3 x the upper limit of normal) was greater for patients treated with triamcinolone acetonide (2.5% for both AST and ALT) compared with canakinumabtreated patients (1.6% for ALT and 0.8% for AST).
Srednje povećanje alanin transaminaze (ALT) od 3,0 U/l i medijan povećanja od 2,0 U/l te srednje povećanje aspartat transaminaze (AST) od 2,7 U/l i medijan povećanja od 2,0 U/l, od početka do kraja ispitivanja, zabilježeno je u skupinama liječenim kanakinumabom u usporedbi sa skupinom (skupinama) liječenom triamcinolon acetonidom, međutim, incidencija klinički značajnih promjena (≥3 x gornja granica normale) bila je veća za bolesnike liječene triamcinolon acetonidom (2,5% i za AST i za ALT) u usporedbi s bolesnicima liječenima kanakinumabom (1,6% za ALT i 0,8% za AST).
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).
Ispitivanja na životinjama pokazala su da protutijelo na mišji IL-1 beta nije imalo neželjenih učinaka na razvoj u mladunčadi miševa koja se doji te da se protutijelo prenijelo na njih (vidjeti dio 5.3).
In clinical studies, canakinumab has been safely administered with ULT.
U kliničkim ispitivanjima kanakinumab se sigurno primjenjivao uz ULT.
Overall, the efficacy, safety and tolerability profile of canakinumab in elderly patients ≥ 65 years of age was comparable to patients < 65 years of age.
Općenito je profil djelotvornosti, sigurnosti i podnošljivosti kanakinumaba u starijih bolesnika u dobi od ≥65 godina bio usporediv s onim kod bolesnika u dobi od <65 godina.
In active-controlled gouty arthritis trials, there was a mean increase in triglycerides of 33.5 mg/dl in canakinumab-treated patients compared with a modest decrease of -3.1 mg/dl with triamcinolone acetonide.
U aktivno kontroliranim ispitivanjima uričnog artritisa došlo je do srednjeg povišenja triglicerida od 33,5mg/dl kod bolesnika liječenih kanakinumabom, u usporedbi sa skromnim smanjenjem od -3,1 mg/dl s triamcinolon acetonidom.
Remove the caps from the Ilaris and water vials.
Uklonite kapice s bočice Ilarisa i bočice s vodom.
Increases in uric acid level (0.7 mg/dl at 12 weeks and 0.5 mg/dl at 24 weeks) were observed after canakinumab treatment in comparative trials in gouty arthritis.
Povišenja razine mokraćne kiseline (0,7 mg/dl nakon 12 tjedana i 0,5 mg/dl nakon 24 tjedna) bila su uočena nakon liječenja kanakinumabom u komparativnim ispitivanjima uričnog artritisa.
9/l) and transient decreases in platelet counts were observed at a higher incidence (12.7%) with canakinumab in the active-controlled clinical studies versus the comparator (7.7%) in gouty arthritis patients.
9/l) i prolazna smanjenja broja trombocita zabilježena su uz veću incidenciju (12,7%) s kanakinumabom u aktivno kontroliranim kliničkim ispitivanjima nego s komparatorom (7,7%) kod bolesnika s uričnim artritisom.
TRAPS, HIDS/MKD and FMF The efficacy and safety of canakinumab for the treatment of TRAPS, HIDS/MKD and FMF were demonstrated in a single, pivotal, phase III, 4-part study (N2301) consisting of three separate disease cohorts.
TRAPS, HIDS/MKD i FMF Djelotvornost i sigurnost kanakinumaba za liječenje TRAPS-a, HIDS/MKD-a i FMF-a dokazane su u jednom ključnom četverodijelnom ispitivanju faze III (N2301) koje se sastojalo od tri zasebne kohorte prema bolesti.
Higher proportions of patients had normalised SAA (≤ 10 mg/l) at week 16 with canakinumab treatment compared to placebo in all three cohorts, with a statistically significant difference observed in TRAPS patients (see Table 3 with study results below).
Viši udjeli bolesnika imali su normalizirani SAA (≤10 mg/l) u 16. tjednu uz liječenje kanakinumabom u usporedbi s placebom u sve tri kohorte, uz statistički značajnu razliku opaženu u bolesnika s TRAPS-om (vidjeti Tablicu 3 s rezultatima ispitivanja u nastavku).
Canakinumab binds to serum IL-1 beta.
Kanakinumab se veže za IL-1 beta u serumu.
Efficacy results in a subgroup of patients unable to use both NSAIDs and colchicine and who were on ULT, failed ULT or had a contraindication to ULT (N=101) were consistent with the overall study population with a statistically significant difference compared to triamcinolone acetonide in pain intensity at 72 hours (-10.2 mm, p=0.0208) and in reduction of risk of subsequent attacks (Hazard ratio 0.39, p=0.0047 at 24 weeks).
Rezultati djelotvornosti u podskupini bolesnika koji nisu mogli koristiti NSAIL-ove i kolhicin i koji su primali ULT, nisu imali odgovora uz ULT ili su imali kontraindikaciju na ULT (N=101) bili su u skladu s onima za cjelokupnu ispitivanu populaciju, uz statistički značajnu razliku u usporedbi s triamcinolon acetonidom u intenzitetu boli nakon 72 sata (-10,2 mm, p=0,0208) i u smanjenju rizika od naknadnih napada (omjer hazarda 0,39, p=0,0047 nakon 24 tjedna).
In the overall SJIA programme, high ALT and/or AST > 3 x upper limit of normal (ULN) were reported in 19 patients (9.5%).
U cjelokupnom programu za SJIA-u zabilježene su visoke razine ALT-a i/ili AST-a > 3 x gornja granica normale (GGN) u 19 bolesnika (9,5%).
Talk to your doctor before using Ilaris if any of the following applies to you: if you currently have an infection or if you have had repeated infections or a condition such as a known low level of white blood cells which makes you more likely to get infections.
Obratite se svom liječniku prije nego primijenite Ilaris ako se bilo što od sljedećeg odnosi na Vas: ako trenutačno imate infekciju ili ste imali opetovane infekcije ili stanje kao što je utvrđena niska razina leukocita zbog koje ste skloniji infekcijama. ako imate ili ste ikad imali tuberkulozu ili izravan kontakt s osobom s aktivnom infekcijom tuberkuloze.
Ilaris is used in adults, adolescents and children to treat active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older if other treatments have not worked well enough.
Ilaris se koristi u odraslih, adolescenata i djece 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 ako druge terapije nisu dovoljno dobro djelovale.
Using aseptic technique, reconstitute each vial of canakinumab at room temperature (typically 15°C to 25°C) by slowly injecting 1 ml water for injections with a 1 ml syringe and an 18 G x 2 inch (50 mm) needle.
Primjenom aseptičke tehnike rekonstituirajte svaku bočicu kanakinumaba na sobnoj temperaturi (obično 15°C do 25°C) tako da polako ubrizgate 1 ml vode za injekcije pomoću štrcaljke od 1 ml i igle od 18 G x 50 mm.
Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype.
Kanakinumab je humano monoklonsko protutijelo protiv humanog interleukina-1 beta (IL-1 beta) izotipa IgG1/κ.
No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving canakinumab.
Nema dostupnih podataka o učincima živih cjepiva ili o sekundarnom prijenosu infekcije putem živih cjepiva kod bolesnika koji primaju kanakinumab.
Now, gently turn the vial upside down and back again ten times, again taking care not to touch the rubber stopper.
Sada lagano deset puta okrenite bočicu naopako i vratite je u prvobitan položaj, pazeći pritom da ne dodirujete gumeni čep.
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.
Dugoročni podaci i laboratorijske abnormalnosti u bolesnika s CAPS-om Tijekom kliničkih ispitivanja s kanakinumabom kod bolesnika s CAPS-om srednje vrijednosti hemoglobina su se povisile, a leukocita, neutrofila i trombocita su se snizile.
Apparent clearance (CL/F) in the TRAPS, HIDS/MKD and FMF population at body weight of 55 kg (0.14 l/d) was comparable to CAPS population at body weight of 70 kg (0.17 l/d).
Prividni klirens (CL/F) u populaciji s TRAPS-om, HIDS/MKD-om i FMF-om pri tjelesnoj težini od 55 kg (0,14 l/d) bio je usporediv s populacijom s CAPS-om pri tjelesnoj težini od 70 kg (0,17 l/d).
Read all the way through these instructions before injecting.
Pročitajte ove upute do kraja prije primjene injekcije.
Activation of macrophages and concomitant over-production of IL-1 beta results in an acute painful inflammatory response.
Aktivacija makrofaga i konkomitantna prekomjerna proizvodnja IL-1 beta imaju za posljedicu akutni bolni upalni odgovor.
In this study, 25 patients who had a strong ACR response for a minimum of 5 months reduced their canakinumab dose to 2 mg/kg every 4 weeks and maintained a paediatric ACR100 response throughout the time the reduced dose was given (median 32 weeks, 8-124 weeks).
U tom ispitivanju, 25 bolesnika koji su imali snažan ACR odgovor najmanje 5 mjeseci smanjilo je dozu kanakinumaba na 2 mg/kg svaka 4 tjedna i održalo pedijatrijski odgovor ACR100 tijekom cijelog razdoblja uzimanja smanjene doze (medijan 32 tjedna, 8-124 tjedana).
Do not use if particles are present in the solution.
Ne upotrebljavajte ako su u otopini prisutne čestice.
Seventy five patients aged 2 to 22 years who maintained inactive disease status for at least 6 consecutive months (clinical remission) with canakinumab monotherapy, including patients who were able to maintain inactive disease status with discontinuation of concomitant corticosteroid and/or methotrexate use for at least 4 weeks, were randomised to receive canakinumab 2 mg/kg every 4 weeks (N=38) or canakinumab 4 mg/kg every 8 weeks (N=37).
Sedamdeset pet bolesnika u dobi od 2 do 22 godine koji su održali status neaktivne bolesti najmanje 6 uzastopnih mjeseci (kliničku remisiju) s monoterapijom kanakinumabom, uključujući bolesnike koji su uspjeli održati status neaktivne bolesti prekidom istodobnog korištenja kortikosteroida i/ili metotreksata najmanje 4 tjedna, bili su randomizirani na primanje 2 mg/kg kanakinumaba svaka 4 tjedna (N=38) ili 4 mg/kg kanakinumaba svakih 8 tjedana (N=37).
CAPS in children 2-< 4 years of age or children  4 years of age  7.5 kg and < 15 kg
CAPS u djece u dobi od 2 do <4 godine ili djeca u dobi od 4 godine i 7,5 kg i <15 kg
Canakinumab treatment improved all paediatric ACR response scores as compared to placebo at days 15 and 29 (Table 4).
Liječenje kanakinumabom poboljšalo je sve rezultate pedijatrijskog ACR odgovora u usporedbi s placebom nakon 15 i 29 dana (Tablica 4).
Common features of AOSD and SJIA include fever, rash, hepatosplenomegaly, lymphadenopathy, polyserositis and arthritis.
Uobičajene karakteristike SBOD-a i SJIA-e uključuju vrućicu, osip, hepatosplenomegaliju, limfadenopatiju, poliserozitis i artritis.
At day 15, the median change from baseline in the number of joints with active arthritis and limited range of motion were -67% and -73% for canakinumab (N=43), respectively, compared to a median change of 0% and 0% for placebo (N=41).
Nakon 15 dana, medijan promjene od početne vrijednosti u broju zglobova s aktivnim artritsom i ograničenim rasponom pokreta bio je -67% odnosno -73% za kanakinumab (N=43), u usporedi s medijanom promjene od 0% odnosno 0% za placebo (N=41).
Do not use after the expiry date which is stated on the label and carton.
Nemojte upotrebljavati nakon isteka roka valjanosti koji je naveden na naljepnici i kutiji.
When stratified by weight, a lower (30-40%) median of exposure for Cmin,ss (11.4 vs 19 µg/ml) and AUCss (594 vs 880 µg*d/ml) for the lower bodyweight category (≤ 40 kg) vs the higher bodyweight category (> 40 kg) was observed.
Kada se stratificira prema težini, uočen je niži (30-40%) medijan izloženosti za Cmin,ss (11,4 naspram 19 µg/ml) i AUCss (594 naspram 880 µg*d/ml) za nižu kategoriju tjelesne težine (≤ 40 kg) u usporedbi s višom kategorijom tjelesne težine (> 40 kg).
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.
Žene koje su primile kanakinumab tijekom trudnoće potrebno je uputiti da o tome obavijeste djetetovog liječnika i medicinsku sestru prije nego novorođenče primi bilo koje cjepivo.
Additional dose of 150 mg can be considered
Može se razmotriti dodatna doza od 150 mg
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).
Djelotvornost kanakinumaba za liječenje akutnih napada uričnog artritisa dokazana je u dva multicentrična, randomizirana, dvostruko slijepa, aktivno kontrolirana ispitivanja kod bolesnika s učestalim uričnim artritisom (≥3 napada u prethodnih 12 mjeseci) koji nisu mogli koristiti NSAIL-ove ili kolhicin (zbog kontraindikacije, intolerancije ili nedostatka djelotvornosti).
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.
Umetnite iglu za prijenos kroz središte čepa na bočici s Ilaris praškom, pazeći pritom da ne dodirujete iglu ili čep.
• Other infections such as ear infection, skin infection (cellulitis), stomach pain and feeling sick (gastroenteritis) and painful and frequent urination with or without fever (urinary tract infection).
• Druge infekcije kao što su infekcija uha, kožna infekcija (celulitis), bol u želucu i osjećaj mučnine (gastroenteritis) te bolno i učestalo mokrenje s vrućicom ili bez nje (infekcija mokraćnog sustava).
Your doctor will discuss with you the potential risks of taking Ilaris before breast-feeding.
Liječnik će razgovarati s Vama o potencijalnim rizicima primjene Ilarisa prije dojenja.
A gouty arthritis attack is caused by urate (monosodium urate monohydrate) crystals in the joint and surrounding tissue, which trigger resident macrophages to produce IL-1 beta via the “NALP3 inflammasome” complex.
Napad uričnog artritisa uzrokuju kristali urata (mononatrij urat monohidrat) u zglobu i okolnom tkivu, što potiče rezidentne makrofage na proizvodnju IL-1 beta preko kompleksa „NALP3 inflamasoma“.
Statistically significant improvements in the Child Health Questionnaire-PF50 scores were reported for canakinumab vs placebo in study G2305 (physical p=0.0012; psychosocial well-being p=0.0017).
Child Health Questionnaire-PF50) bila su zabilježena uz kanakinumab u odnosu na placebo u ispitivanju G2305 (tjelesna p=0,0012; psihosocijalna dobrobit p=0,0017).
Study G2306
Ispitivanje G2306
Adverse reactions are listed according to MedDRA system organ class.
Nuspojave su navedene prema klasifikaciji organskih sustava po MedDRA-i.
Then apply an adhesive plaster.
Zatim stavite ljepljivi flaster.
Ilaris should be given in combination with colchicine, if appropriate.
Ilaris je potrebno davati u kombinaciji s kolhicinom, ako je primjereno.
Each vial is for single use in a single patient, for a single dose.
Svaka bočica namijenjena je za jednokratnu primjenu jedne doze u jednog bolesnika.
If there are air bubbles in the syringe, remove bubbles as instructed by your healthcare provider.
Ako u štrcaljki ima mjehurića zraka, uklonite mjehuriće prema uputama zdravstvenog djelatnika.
Efficacy and safety of canakinumab in young adult SJIA patients aged 16 to 20 years were consistent with the efficacy and safety observed for patients less than 16 years of age.
Djelotvornost i sigurnost kanakinumaba u mladih bolesnika sa SJIA-om u dobi od 16 do 20 godina bile su u skladu sa zabilježenom djelotvornošću i sigurnošću u bolesnika mlađih od 16 godina.
These include shivering, chills, malaise, loss of appetite, body aches, typically in connection with a sudden onset of illness, sore throat or mouth ulcers, cough, phlegm, chest pain, difficulty breathing, ear pain, prolonged headache or localised redness, warmth or swelling of your skin or inflammation of connective tissue (cellulitis).
Oni uključuju drhtanje, zimicu, malaksalost, gubitak apetita, tupe bolove u tijelu, obično povezane s iznenadnim nastupom bolesti, grlobolju ili čireve u ustima, kašalj, sluz, bol u grudima, poteškoće s disanjem, bol u uhu, produljenu glavobolju ili lokalizirano crvenilo, toplinu ili oticanje kože ili upalu vezivnog tkiva (celulitis).
Pooled efficacy analysis
Objedinjena analiza djelotvornosti
In TRAPS, HIDS/MKD and FMF, exposure parameters (trough concentrations) were comparable across age groups from 2 to < 20 years old following subcutaneous administration of canakinumab 2 mg/kg every 4 weeks.
Kod TRAPS-a, HIDS/MKD-a i FMF-a, parametri izloženosti (najniže koncentracije) bili su usporedivi među dobnim skupinama od 2 do <20 godina starosti nakon supkutane primjene kanakinumaba od 2 mg/kg svaka 4 tjedna.