natgillin/translations-raw huggingface dataset:
Once the required volume is withdrawn, recap and remove the withdrawal needle from the syringe and attach a 27 G x 0.5 inch needle (or similar as available on the market) to immediately inject the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.
Ko v brizgo potegnete ustrezno količino raztopine, iglo za izvlek pokrijte s pokrovčkom in jo odstranite z brizge, nato pa na brizgo namestite iglo 27 G x 0,5 palca (ali podobno iglo, ki je na voljo na trgu) in raztopino takoj subkutano injicirajte.
2 In gouty arthritis
2 pri uričnem artritisu
If not used immediately after reconstitution, the solution should be kept at 2°C to 8°C and used within 24 hours.
Če raztopine ne uporabite takoj po rekonstituciji, jo shranite pri temperaturi od 2 °C do 8 °C in uporabite v roku 24 ur.
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).
Vrednost navideznega očistka (CL/F) v populaciji bolnikov s sindromi TRAPS, HIDS/MKD ali FMF s telesno maso 55 kg (0,14 l/dan) je podobna kot v populaciji bolnikov s CAPS s telesno maso 70 kg (0,17 l/dan).
A 6-year observational registry study was conducted to provide data on the long-term safety and effectiveness of canakinumab treatment in paediatric and adult CAPS patients in routine clinical practice.
Za pridobitev podatkov o dolgoročni varnosti in učinkovitosti zdravljenja s kanakinumabom pri pediatričnih in odraslih bolnikih s CAPS v okviru rutinske klinične prakse so izvedli 6-letno opazovalno registrsko študijo.
p=0.2798 Risk reduction of subsequent gouty arthritis attacks as measured by time to first new flare (24 weeks)
zmanjševanje tveganja za nadaljnje napade uričnega artritisa: čas do prvega novega napada (v 24 tednih)
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 preskušanja zdravljenja periodičnih sindromov, povezanih s kriopirinom (CAPS), s kanakinumabom so vključevala skupno 80 pediatričnih bolnikov v starosti od 2 do 17 let (približno polovica teh bolnikov je prejemala odmerke zdravila na osnovi mg/kg telesne mase).
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 bolezen z začetkom v odrasli dobi in sistemski juvenilni idiopatski artritis sta hudi avtovnetni bolezni, pri katerih ima poglavitno vlogo prirojena imunost, in sicer provnetni citokini, med katerimi je najbolj pomemben IL-1-beta.
In the overall study population, patients on ULT had a less pronounced treatment difference in both pain reduction and reduction in the risk of subsequent gouty arthritis attacks compared to patients not on ULT.
V celotni študijski populaciji je bila pri bolnikih, ki so uporabljali zdravila za zmanjševanje količine urata, razlika med načinoma zdravljenja glede zmanjševanja bolečine in tveganja za nadaljnje napade uričnega artritisa manj izrazita kot pri bolnikih, ki niso jemali zdravil za zmanjševanje količine urata.
This is consistent with the observed increase in CL/F with body weight.
To se ujema z ugotovitvijo, da se navidezni očistek (Cl/F) povečuje z večanjem telesne mase.
Allow the vial to warm to room temperature before injection.
Vialo z zdravilom pred injiciranjem ogrejte na sobno temperaturo.
The decision whether to breast-feed during canakinumab therapy should therefore only be taken after a thorough benefit-risk evaluation.
Za dojenje v času zdravljenja s kanakinumabom se je zato smiselno odločiti šele po temeljitem razmisleku o razmerju med tveganji in koristmi.
Very common Respiratory tract infections (including pneumonia, bronchitis, influenza, viral infection, sinusitis, rhinitis, pharyngitis, tonsillitis, nasopharyngitis, upper respiratory tract infection)
Infekcijske in parazitske bolezni zelo pogosti okužbe dihal (kar vključuje pljučnico, bronhitis, gripo, virusno okužbo, sinusitis, rinitis, faringitis, tonzilitis, nazofaringitis, okužbo zgornjih dihal) okužba ušesa flegmona gastroenteritis okužba sečil pogosti vulvovaginalna kandidoza
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).
V vseh treh kohortah je do konca 16. tedna prišlo do normalizacije vrednosti SAA (≤ 10 mg/l) pri večjem deležu bolnikov s kanakinumabom kot pri tistih s placebom, pri čemer so statistično značilno razliko opažali pri bolnikih s sindromom TRAPS (glejte spodaj rezultate v preglednici 3).
Overall, the efficacy, safety and tolerability profile of canakinumab in elderly patients ≥ 65 years of age was comparable to patients < 65 years of age.
V celoti so bile učinkovitost, varnost in prenašanje kanakinumaba pri bolnikih, starih 65 let ali več, primerljive s tistimi pri bolnikih, mlajših od 65 let.
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Zdravila ne uporabljajte, če tekočina vsebuje vidne delce, je motna ali izrazito rjave barve.
canakinumab treatment improved all paediatric ACR response scores as compared to placebo at days 15 and 29 (Table 4).
Zdravljenje s kanakinumabom je v primerjavi s placebom izboljšalo vse ocene pediatričnih kriterijev odziva ACR na 15. in 29. dan (preglednica 4).
Part I: A complete clinical and biomarker response to canakinumab (defined as composite of physician's global assessment on autoinflammatory and on skin disease ≤ minimal and CRP or SAA values < 10 mg/litre) was observed in 97% of patients and appeared within 7 days of initiation of treatment.
1. obdobje: Popoln klinični odziv na kanakinumab in odziv z biološkimi označevalci (opredeljen kot malo aktivna ali neaktivna tako avtoimunska kot kožna bolezen glede na zdravnikovo celotno oceno hkrati s koncentracijami CRP ali SAA, nižjimi od 10 mg/liter) so opažali pri 97 % bolnikov, do takega odziva pa je prišlo v 7 dneh od začetka zdravljenja.
The apparent volume of distribution per kg (V/F per kg) was 0.14 l/kg.
Navidezni volumen porazdelitve na kilogram telesne mase (V/F na kg) je znašal 0,14 l/kg.
Your healthcare provider will instruct you on the right amount for you.
Usposobljen zdravstveni delavec vam bo povedal, koliko raztopine morate uporabiti vi.
Laboratory abnormalities in SJIA patients
Patološki laboratorijski izvidi pri bolnikih s SJIA
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.
Pri sindromih CAPS, TRAPS, HIDS/MKD in FMF ter Stillovi bolezni sme zdravljenje uvesti in nadzirati zdravnik specialist, ki ima izkušnje z odkrivanjem in zdravljenjem omenjenih indikacij.
Multipack: 4 (4x1) vials.
prašek za raztopino za injiciranje Skupno pakiranje: 4 (4x1) viale.
There was no indication of accelerated clearance or time-dependent change in the pharmacokinetic properties of canakinumab following repeated administration.
Po večkratnem odmerjanju ni bilo znakov za pospešeno izločanje ali za spremenjen časovni potek farmakokinetičnih lastnosti kanakinumaba.
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.
O znižanem številu levkocitov (vrednostih, ki so bile enake ali nižje kot 0,8-kratnik spodnje meje normalnih vrednosti) so poročali pri 6,7 % bolnikov, ki so prejemali kanakinumab, v primerjavi z 1,4 % bolnikov, ki so prejemali triamcinolon acetonid.
Instructions for use of Ilaris powder for solution for injection
Navodila za uporabo zdravila Ilaris prašek za raztopino za injiciranje
A murine antimurine IL-1 beta antibody had no undesirable effects on fertility in male or female mice (see section 5.3).
Glodalsko protitelo proti glodalskemu IL-1 beta ni škodljivo vplivalo na plodnost niti pri mišjih samcih niti pri samicah (glejte poglavje 5.3).
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).
Zdravilo Ilaris je na voljo v obliki praška za raztopino za injiciranje v (150 mg v 6-mililitrski stekleni viali).
• 150 mg for patients with body weight > 40 kg
150 mg za bolnike s telesno maso > 40 kg
Slowly pull the syringe plunger up to the correct mark (amount to be given), filling the syringe with Ilaris solution.
Počasi potegnite bat brizge navzgor do pravilne oznake (do oznake za količino, ki jo morate injicirati) in tako napolnite brizgo z raztopino Ilaris.
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).
Priporočeni odmerek zdravila Ilaris za bolnike s Stillovo boleznijo (AOSD ali SJIA) in telesno maso najmanj 7,5 kg je 4 mg/kg (do največ 300 mg).
Disease activity was rated as absent or mild/moderate in more than 90% of patients at all post-baseline time points in the study, and median serological markers of inflammation (CRP and SAA) were normal (< 10 mg/litre) at all post-baseline time points.
Pri več kot 90 % bolnikov so v študiji, pri vseh časovnih točkah opazovanja po izhodiščnem, ocenili aktivnost bolezni kot odsotno ali blago/zmerno, mediane vrednosti seroloških označevalcev vnetja (CRP in SAA) pa so bile normalne (< 10 mg/liter) pri vseh časovnih točkah opazovanja po izhodiščnem.
All up-titrated patients remained at the increased dose of 300 mg (or 4 mg/kg for patients ≤ 40 kg) every 4 weeks.
Vsi bolniki, ki so jim tako zvišali odmerjanje, so še naprej prejemali zvišan odmerek 300 mg (oziroma 4 mg/kg pri bolnikih s telesno maso ≤ 40 kg) vsake 4 tedne.
If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible.
Če pride do razvoja sindroma aktivacije makrofagov ali je postavljen sum nanj, je treba čimprej začeti s preiskavami in zdravljenjem.
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).
Na 15. dan je bila v skupini s kanakinumabom (N=43) mediana sprememba od izhodišča glede števila sklepov z aktivnim artritisom -67 %, glede števila sklepov z omejeno gibljivostjo pa -73 % v primerjavi s tovrstnima medianima spremembama 0 % oziroma 0 % v skupini s placebom (N=41).
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.
Priporočeni odmerek kanakinumaba za bolnike s Stillovo boleznijo (AOSD ali SJIA) s telesno maso ≥ 7,5 kg je 4 mg/kg (do največ 300 mg), ki jih bolnik dobi vsake štiri tedne s subkutano injekcijo.
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) in prehodna znižanja števila trombocitov opažali z večjo pogostnostjo (12,7 %) pri bolnikih, ki so prejemali kanakinumab, kot pri tistih, ki so prejemali primerjalno zdravilo (7,7 %).
Patients in Part II (double-blind) received either canakinumab 4 mg/kg or placebo every 4 weeks until 37 flare events occurred.
V 2. obdobju (dvojno slepo zdravljenje) so bolniki prejemali bodisi kanakinumab 4 mg/kg ali placebo vsake 4 tedne, dokler ni prišlo do 37 dogodkov, ki pomenijo zagon bolezni.
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.
V 1. obdobju (odprto zdravljenje) je bilo vključenih 177 bolnikov, ki so prejemali odmerke 4 mg/kg (največ 300 mg) kanakinumaba vsake 4 tedne do 32 tednov.
Set the syringe aside.
Odložite brizgo.
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.
Skupno ni bilo klinično pomembnih razlik glede učinkovitosti, varnosti in prenašanja kanakinumaba pri pediatričnih bolnikih v primerjavi s celotno populacijo bolnikov s CAPS.
- Keep the vial in the outer carton in order to protect from light.
- Shranjujte vialo v zunanji škatli za zagotovitev zaščite pred svetlobo.
A total of 225 patients were treated with subcutaneous canakinumab 150 mg and 229 patients were treated with intramuscular triamcinolone acetonide (TA) 40 mg at study entry, and when experiencing a new attack thereafter.
Ob vstopu v študijo je skupno 225 bolnikov subkutano prejemalo kanakinumab 150 mg, 229 bolnikov pa intramuskularno triamcinolon acetonid (TA) 40 mg.
Bioavailability in gouty arthritis patients has not been determined independently.
Biološke uporabnosti zdravila pri bolnikih z uričnim artritisom niso določali posebej.
The recommended dose of canakinumab for adult patients with gouty arthritis is 150 mg administered subcutaneously as a single dose during an attack.
Priporočeni odmerek kanakinumaba za odrasle bolnike z uričnim artritisom je 150 mg, ki ga prejmejo subkutano kot enkraten odmerek v času napada.
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 uričnega artritisa sprožijo uratni kristali (natrijev urat monohidrat) v sklepih in okolnem tkivu, ki aktivirajo tamkajšnje makrofage, da začno s pomočjo kompleksa "imflamasom NALP3" izdelovati IL-1 beta.
Laboratory abnormalities in gouty arthritis patients Haematology
Patološki laboratorijski izvidi pri bolnikih z uričnim artritisom Hematološki izvidi
Injection into scar tissue should be avoided as this may result in insufficient exposure to canakinumab.
Injiciranje zdravila v brazgotino ni primerno, ker bi lahko prišlo do prenizke koncentracije kanakinumaba v telesu.
Choose an injection site on the upper thigh, abdomen, upper arm or buttocks.
Izberite mesto za injiciranje na zgornjem delu stegna, na trebuhu, na nadlakti ali na zadnjici.
Mild and transient Grade 1 reduction in platelets occurred in 15.9% of patients without any associated bleeding adverse events.
Pri 15,9 % bolnikov je prišlo do blagega in prehodnega znižanja števila trombocitov stopnje 1 brez neželenih krvavitev, ki bi bile povezane s tem.
The efficacy and safety profile in AOSD patients are expected to be similar to SJIA patients based on literature reports.
Po podatkih poročil iz literature je pri bolnikih z AOSD mogoče pričakovati podobna profila učinkovitosti in varnosti kot pri bolnikih s SJIA.
Open the wrappers containing the syringe and the transfer needle (the 50 mm needle) and attach the needle to the syringe.
Odprite zavoja z brizgo in z iglo za prenos (dolžine 50 mm) in iglo namestite na brizgo.
Efficacy results for a more stringent subgroup limited to current users of ULT (N=62) are presented in Table 5.
Rezultati učinkovitosti za ožjo podskupino bolnikov, ki so tedaj uporabljali zdravila za zmanjševanje količine urata, (N=62), so prikazani v preglednici 5.
• Cryopyrin-associated periodic syndromes (CAPS),
• s kriopirinom povezani periodični sindromi (angl. cryopyrin-associated periodic syndromes, s kratico CAPS),
All indications: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, gouty arthritis
Vse indikacije: sindromi CAPS, TRAPS, HIDS/MKD in FMF, SJIA, urični artritis
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.
Če ne pride do zadovoljivega kliničnega odziva 7 dni po tem zvišanju odmerka, je mogoče razmisliti o uporabi tretjega odmerka 300 mg oziroma 4 mg/kg kanakinumaba.
Treatment difference for all ACR scores was significant (p ≤ 0.0001)
ACR100 neaktivna bolezen razlika med ocenami ACR pri obeh načinih zdravljenja je bila v vseh primerih statistično značilna (p ≤ 0,0001)
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).
Primarni cilj študije za oceno učinkovitosti v obdobju randomiziranega zdravljenja (v 2. obdobju) je bil za vsako od kohort delež bolnikov z odzivom, pri katerih so do 15. dne izzveneli njihovi značilni znaki in simptomi zagona, v preostanku 16-tedenskega obdobja zdravljenja pa ni prišlo do novega zagona (kar je bilo opredeljeno kot popolni odziv).
Ilaris has not been studied in patients with hepatic impairment.
Uporabe zdravila Ilaris pri bolnikih z okvaro jeter niso proučevali.
A total of 243 CAPS patients (85 paediatric patients aged ≥ 2 to ≤ 17 years and 158 adult patients aged ≥ 18 years) were treated with canakinumab in routine clinical practice in a long-term registry study (mean of 3.8 years of canakinumab exposure).
V dolgoročni registrski študiji so v okviru rutinske klinične prakse s kanakinumabom zdravili skupno 243 bolnikov s CAPS (85 pediatričnih bolnikov v starosti od ≥ 2 do ≤ 17 let in 158 odraslih bolnikov, starih ≥ 18 let) s povprečno 3,8 let izpostavljenosti kanakinumabu.
Inflammatory markers* C-reactive protein, mg/l Serum amyloid A, mg/l * mean (median) change from beginning of Part II
vrednost p primarni cilj opazovanja (zagon bolezni) delež bolnikov z zagonom bolezni v 2. obdobju vnetni označevalci* C-reaktivni protein, mg/l serumski amiloid A, mg/l * povprečje (mediana) spremembe od začetka 2. obdobja
- 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.
- 3. obdobje: bolnike, ki so zaključili 16 tednov zdravljenja in so bili opredeljeni kot odzivni bolniki, so randomizirali v 24-tedensko dvojno slepo obdobje opuščanja zdravila, v katerem so subkutano prejemali kanakinumab v odmerku 150 mg (oziroma 2 mg/kg pri bolnikih s telesno maso ≤ 40 kg) ali placebo vsakih 8 tednov.
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.
Pri bolnikih s sindromi TRAPS, HIDS/MKD in FMF so bili parametri izpostavljenosti (najnižje koncentracije pred naslednjim odmerkom) po subkutanem odmerjanju kanakinumaba 2 mg/kg vsake 4 tedne primerljivi med vsemi starostnimi skupinami pri bolnikih, ki so bili stari od 2 leti do < 20 let.
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.
Priporočeni odmerek zdravila za odrasle bolnike z uričnim artritisom je 150 mg v enkratnem odmerku v času napada uričnega artritisa.
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
Bolezni prebavil zelo pogosti bolečine v zgornjem delu trebuha občasni gastro-ezofagealna refluksna bolezen Bolezni kože in podkožja zelo pogosti reakcija na mestu injiciranja
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).
Predvidene vrednosti izpostavljenosti v stanju dinamičnega ravnovesja (najnižje koncentracije v stanju dinamičnega ravnovesja (Cmin,ss), najvišje koncentracije v stanju dinamičnega ravnovesja (Cmax,ss), površina pod krivuljo v stanju dinamičnega ravnovesja pri odmerjanju vsakih 8 tednov (AUC,ss,8w)) po subkutanem odmerjanju 150 mg (oziroma 2 mg/kg) vsakih 8 tednov so bile nekoliko višje v kategoriji bolnikov s telesno maso 40-70 kg (6,6 µg/ml, 24,3 µg/ml, 767 µg*d/ml) v primerjavi s kategorijama < 40 kg (4,0 µg/ml, 19,9 µg/ml, 566 µg*d/ml) in > 70 kg (4,6 µg/ml, 17,8 µg/ml, 545 µg*d/ml).
Overall, there were no clinically meaningful differences in the safety and tolerability profile of canakinumab in paediatric patients compared to the overall population.
V celoti niso opažali klinično pomembnih razlik glede varnostnih lastnosti in prenosljivosti kanakinumaba pri pediatričnih bolnikih v primerjavi s celotno populacijo.
Instructions for use of Ilaris solution for injection
Navodila za uporabo raztopine za injiciranje zdravila Ilaris
The safety profile of canakinumab appeared similar to that in patients aged 2 years and above.
Pokazalo se je, da so bile varnostne lastnosti kanakinumaba podobne kot pri bolnikih, ki so stari 2 leti ali več.
Ilaris is injected every 8 weeks as a single dose.
Bolnik prejme zdravilo Ilaris v obliki injekcije, in sicer vsakih 8 tednov en odmerek.
In the overall SJIA programme, transient decreased white blood cell (WBC) counts ≤ 0.8 x LLN were reported in 33 patients (16.5%).
V celotnem programu študij SJIA so o prehodno znižanem številu levkocitov na ≤ 0,8-kratnik spodnje meje normalnih vrednosti poročali pri 33 bolnikih (16,5 %).
- 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.
- Če 7 dni po začetku zdravljenja ne pride do dovolj dobrega odziva na zdravljenje, vam bo zdravnik morda dal še en odmerek 150 mg oziroma 2 mg/kg.
Hypersensitivity reactions have been reported in patients treated with canakinumab (see sections 4.3 and 4.4).
Pri bolnikih, ki so prejemali kanakinumab, so poročali o preobčutljivostnih reakcijah (glejte poglavji 4.3 in 4.4).
Do not touch the vial stoppers.
Ne dotikajte se zamaška na viali.
Canakinumab should be used as an on-demand therapy to treat gouty arthritis attacks.
Kanakinumab je treba uporabljati le po potrebi za zdravljenje napadov uričnega artritisa.
Data from the first 12 weeks of canakinumab treatment from studies G2305, G2301 and the extension study were pooled to assess maintenance of efficacy.
Analiza združenih podatkov za oceno učinkovitosti Za oceno ohranjanja učinkovitosti so združili podatke prvih 12 tednov zdravljenja s kanakinumabom iz študij G2305, G2301 in iz podaljšanja študije.
Dispose of the needle and syringe in the sharps container without recapping or removing the needle.
Iglo in brizgo zavrzite v zbiralnik za ostre predmete, ne da bi prej pokrili iglo s pokrovčkom ali iglo odstranjevali z brizge.
Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during canakinumab treatment.
V času zdravljenja s kanakinumabom so poročali o posameznih primerih neobičajnih ali oportunističnih okužb (kar vključuje aspergilozo, atipične okužbe z mikobakterijami, herpes zoster).
Do not touch the needles or the top of the vial.
Pri rokovanju se ne dotikajte igle in vrha vial.
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.
Prenehanje značilnih znakov in simptomov zagona je bilo opredeljeno z oceno < 2 na lestvici zdravnikove splošne ocene (PGA-Physician's Global Assessment) na lestvici aktivnosti bolezni (kar pomeni “minimalna aktivnost ali odsotnost bolezni”) in vrednostjo CRP v okviru normalnih vrednosti (≤ 10 mg/l) ali znižanjem vrednosti CRP za ≥ 70 % od izhodiščne.