natgillin/translations-raw huggingface dataset:
The mean plasma clearance of Kineret in subjects with mild (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-49 ml/min) renal insufficiency was reduced by 16% and 50%, respectively.
Srednji klirens Kinereta u plazmi u bolesnika s blagom insuficijencijom bubrega (klirens kreatinina 50-80 ml/min) bio je manji za 16%, a u onih s umjerenom insuficijencom bubrega (klirens kreatinina 30-49 ml/min) 50% manji.
For a small number of patients with asthma, the incidence of serious infection was higher in Kineret-treated patients (4.5%) vs. placebo-treated patients (0%), these infections were mainly related to the respiratory tract.
U manjeg broja bolesnika s astmom, incidencija ozbiljne infekcije bila je viša u bolesnika liječenih Kineretom (4,5%) naspram bolesnika liječenih placebom (0%).
CAPS: Posology and administration in children and infants aged 8 months and older with a body weight of 10 kg or above are the same as for adult CAPS patients, based on body weight.
CAPS: Doziranje i način primjene u djece i dojenčadi u dobi od 8 mjeseci i starijih s tjelesnom težinom od najmanje 10 kg isti su kao i u odraslih bolesnika s CAPS-om, razmjerno tjelesnoj težini.
Do not inject more Kineret.
Ne injicirajte više Kinereta nego što je potrebno.
- Thrombocytopenia (low level of blood platelets).
- Trombocitopenija (niske razine trombocita u krvi)
The patient and caregiver information pack should contain:
Informacijski paket za bolesnike i njegovatelje treba sadržavati:
- In rare cases patients with Still's disease, mainly children, may develop lung disease, also during Kineret treatment.
U rijetkim slučajevima, uključujući i tijekom liječenja lijekom Kineret, bolesnici sa Stillovom bolešću, uglavnom djeca, mogu razviti bolest pluća.
You must not be given live vaccines while being treated with
Ne smijete primati živa cjepiva dok se liječite Kineretom.
Kineret.
Kineretom.
No dose adjustment is needed for patients with mild renal impairment (CLcr 60 to 89 ml/min).
Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem bubrega (CLcr 60 do 89 ml/min).
MedDRA Organ System Frequency
MedDRA organski sustav Učestalost
Clear, colourless-to-white solution for injection that may contain some product-related translucentto-white amorphous particles.
Bistra, bezbojna do bijela otopina za injekciju koja može sadržavati neke prozirne do bijele amorfne čestice porijeklom od lijeka.
This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 100 mg, tj. zanemarive količine natrija.
Discard any unused medicinal product.
Bacite neiskorišteni lijek.
Neutropenia Thrombocytopenia
Neutropenija Trombocitopenija
An adverse event profile similar to that seen in adult RA patients was observed in these studies.
U tim su ispitivanjima zabilježeni štetni događaji slični onima u odraslih bolesnika s RA.
• The early signs indicative of MAS
• Rane znakove koji upućuju na MAS
Kineret was commonly associated with neutropenia (ANC < 1.5 x 109/l) in placebo-controlled studies in RA and cases of neutropenia have been observed in patients with CAPS and Still's disease.
U ispitivanjima kontroliranim placebom Kineret je često bio povezan s neutropenijom (ABN < 1,5 x 109/l) u bolesnika s RA, a primijećeni su i slučajevi neutropenije u bolesnika s CAPS-om i Stillovom bolešću.
Accordingly, the decrease in clearance is most likely explained by a decrease in renal function in this population.
Iz toga se može zaključiti da je smanjenje klirensa posljedica smanjene bubrežne funkcije u toj populaciji.
In CAPS patients approximate dose linearity with a slight tendency to higher than proportional increase has been noted.
CAPS-om utvrđeno je da je približna linearnost doze blago povišena, a ne proporcionalna dozi.
To give yourself or your child a subcutaneous injection you will need:
Da biste sebi ili svom djetetu dali potkožnu injekciju potrebna Vam je: • napunjena štrcaljka Kinereta
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGES
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENE ŠTRCALJKE
After a 1-month blinded phase, 8 of 12 patients in the Kineret treated group were identified as modified ACRpedi30 responders compared to 1 of 12 in the placebo group.
12 bolesnika u skupini liječenoj Kineretom identificirani su kao bolesnici s modificiranim odgovorom ACRpedi30 u usporedbi s 1 od 12 bolesnika u skupini koja je primala placebo.
Concurrent Kineret and TNF-α antagonist treatment Concurrent administration of Kineret and etanercept has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone in RA patients.
Istodobna primjena Kinereta i etanercepta u bolesnika s RA povezana je s povećanim rizikom od ozbiljnih infekcija i neutropenije u usporedbi sa samim etanerceptom.
The impact of treatment with Kineret on pre-existing malignancy has not been studied.
Utjecaj liječenja Kineretom na prethodna maligna stanja nije ispitivan.
Remember
Ne zaboravite
• The importance of explaining the use of the syringe and correct injection technique to patients and/or caregivers
• Zašto je važno bolesnicima i/ili njegovateljima objasniti način uporabe štrcaljke i ispravne tehnike ubrizgavanja
Before administration, visually inspect the solution for particulate matter and discolouration.
Prije primjene vizualno pregledati otopinu na prisutnost čestica i promjenu boje.
Patients should be screened for latent tuberculosis prior to initiating Kineret.
Prije početka liječenja Kineretom bolesnici trebaju napraviti pretragu za otkrivanje latentne tuberkuloze.
Keep this medicine out of the sight and reach of children.
Kako čuvati Kineret Lijek čuvajte izvan pogleda i dohvata djece.
There is limited experience in treating elderly CAPS and Still's disease patients.
Iskustva u liječenju starijih osoba s CAPS-om i Stillovom bolešću su ograničena.
• a sterile gauze or tissue
• sterilna gaza ili maramica
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free'.
Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 100 mg, tj. zanemarive količine natrija.
For Still´s disease, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as rash, joint pain and fever.
U slučaju Stillove bolesti, Kineret se koristi za ublažavanje znakova i simptoma upale povezanih s bolesti, kao što su osip, bol u zglobovima i vrućica.
Injection site reactions
Reakcija na mjestu primjene
It must be a clear, colourless-to-white solution.
Mora biti prozirna, bezbojna do bijela otopina.
In patients who become neutropenic (ANC < 1.5 x 109/l) the ANC should be monitored closely and Kineret treatment should be discontinued.
U bolesnika u kojih se pojavi neutropenija (ABN < 1,5 x 109/l) treba pomno nadzirati apsolutni broj neutrofila te prekinuti liječenje Kineretom.
100 mg dose” section.
100 mg“.
Method of administration Kineret is administered by subcutaneous injection.
Kineret se primjenjuje supkutanom injekcijom.
These data support that no dose adjustment is required for patients with hepatic dysfunction of Child-Pugh Class B. See section 4.2.
Ti podaci potvrđuju da nije potrebna prilagodba doze za bolesnike s poremećajem jetrene funkcije Child-Pughovog stadija B.
Allergic reactions including anaphylactic reactions, angioedema, urticaria, rash, and pruritus have been reported uncommonly with Kineret.
Alergijske reakcije, uključujući anafilaktičke reakcije, angioedem, urtikariju, osip i pruritus, prijavljuju se manje često u liječenju Kineretom.
In 15 SJIA patients followed for up to 1.5 years, one event of transient neutropenia was reported.
U 15 bolesnika sa SJIA koji su praćeni do 1,5 godine prijavljen je jedan slučaj prolazne neutropenije.
X-ray examinations have been undertaken in one clinical study with anakinra.
U jednom kliničkom ispitivanju anakinre obavljeni su rendgenski pregledi.
In placebo-controlled RA studies with Kineret, treatment was associated with small reductions in the mean values for total white blood count and absolute neutrophil count (ANC).
U placebom kontroliranim kliničkim ispitivanjima u bolesnika s RA liječenje Kineretom bilo je povezano s malim sniženjem prosječnih vrijednosti za ukupni broj leukocita i apsolutni broj neutrofila
Still's disease: Children weighing less than 50 kg are dosed by body weight with a starting dose of 1-2 mg/kg/day, patients weighing 50 kg or more are dosed with 100 mg/day.
Stillova bolest: U djece s tjelesnom težinom manjom od 50 kg doza se određuje prema tjelesnoj težini s početnom dozom od 1-2 mg/kg/dan, a u bolesnika tjelesne težine 50 kg ili više primjenjuje se doza od
In 43 CAPS patients followed for up to 5 years neutropenia was reported in 2 patients.
U 43 bolesnika s CAPS-om koji su praćeni najdulje do 5 godina neutropenija je prijavljenja u
In 43 CAPS patients followed for up to 5 years no patient permanently or temporarily discontinued Kineret treatment due to injection site reactions.
U 43 bolesnika s CAPS-om koji su praćeni najdulje do 5 godina, nijedan bolesnik nije trajno ili privremeno prekinuo liječenje Kineretom zbog ISR.
Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of CAPS, including: - Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological,
Kineret je indiciran u odraslih, adolescenata, djece i dojenčadi u dobi od 8 mjeseci i starije s tjelesnom težinom od najmanje 10 kg ili više za liječenje CAPS-a, uključujući: - neonatalnu multisistemsku upalnu bolest (engl.
Cutaneous, Articular Syndrome (CINCA) - Muckle-Wells Syndrome (MWS) - Familial Cold Autoinflammatory Syndrome (FCAS)
Familial Cold Autoinflammatory Syndrome - FCAS)
The safety and efficacy of Kineret in patients with neutropenia have not been evaluated.
Sigurnost i djelotovornost Kinereta u bolesnika s neutropenijom nije utvrđena.
Kineret 100 mg/0.67 ml injection Anakinra
Kineret 100 mg/0,67 ml injekcija anakinra s.c.
Mild thrombocytopenia has also been observed in CAPS patients.
Blaga trombocitopenija zabilježena je i u bolesnika s CAPS-om.
• The prescribed dose of Kineret
• Propisanu dozu Kinereta
Clinical efficacy and safety in Still's disease
Klinička djelotvornost i sigurnost u Stillovoj bolesti
Solution for injection in pre-filled syringe 7 GRADUATED pre-filled syringes This box containing 7 pre-filled syringes is part of a 28-multipack.
Ova kutija sadrži 7 napunjenih štrcaljki te je dio višestrukog pakiranja od 28 štrcaljki.
Each graduated pre-filled syringe contains 100 mg of anakinra.
Svaka kalibrirana napunjena štrcaljka sadrži 100 mg anakinre.
With careful monitoring, Kineret treatment can be continued also during a serious infection.
Liječenje Kineretom može se nastaviti i tijekom ozbiljnih infekcija, ali uz pažljivo praćenje.
Kineret is a sterile unpreserved solution.
Kineret je sterilna otopina bez konzervansa.
In addition cases of non-infectious hepatitis, including occasional events of acute liver failure, have been reported in patients with Still's disease during Kineret treatment.
Nadalje, u bolesnika sa Stillovom bolešću tijekom liječenja Kineretom prijavljeni su slučajevi neinfektivnog hepatitisa, uključujući povremeno i slučajeve akutnog zatajenja jetre.
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Kineret 100 mg/0,67 ml otopina za injekciju u napunjenoj štrcaljki.
Patients are usually well-controlled by maintaining the recommended starting dose (1-2 mg/kg/day).
Doza održavanja kod blagog CAPS-a (FCAS, blagi MWS) Bolest se obično može dobro kontrolirati održavanjem preporučene početne doze (1-2 mg/kg/dan).
Talk to your doctor before using Kineret: - if you have a history of recurring infections, or if you suffer from asthma.
- ako imate ponavljajuće infekcije u povijesti bolesti ili patite od astme.
In a clinical study including 43 adult and paediatric patients (36 patients aged 8 months to < 18 years) with severe CAPS (NOMID/CINCA and MWS), a clinical response to anakinra was seen within 10 days after initiation of treatment in all patients and was sustained for up to 5 years with the continued administration of Kineret.
U kliničkom ispitivanju koje je uključivalo 43 odraslih i pedijatrijskih ispitanika (36 ispitanika bilo je u dobi od 8 mjeseci do < 18 godina) s teškim oblikom CAPS-a (NOMID/CINCA i MWS)
Package leaflet: Information for the user Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe
Uputa o lijeku: Informacije za korisnika Kineret 100 mg/0,67 ml otopina za injekciju u napunjenoj štrcaljki anakinra
Combined anakinra and methotrexate treatment demonstrates a statistically and clinically significant reduction in the severity of the signs and symptoms of RA in patients who have had an inadequate response to methotrexate alone (38% vs. 22% responders as measured by ACR20 criteria).
Kombinirano liječenje anakinrom i metotreksatom pokazuje statistički i klinički značajno smanjenje težine znakova i simptoma RA u bolesnika koji su imali neodgovarajući odgovor na sam metotreksat
These have shown no deleterious effect on joint cartilage.
Rendgenske snimke nisu pokazale štetni učinak na hrskavicu zgloba.
Uncommon (≥ 1/1,000 to < 1/100) Allergic reactions including anaphylactic reactions, angioedema, urticaria and pruritus
Alergijske reakcije koje uključuju anafilaktičke reakcije, angioedem, urtikariju i pruritus
The 50 patients who achieved a clinical response after a 12-week open-label run-in were randomized to Kineret (25 patients) or placebo (25 patients), administered daily for an additional 16 weeks.
16 tjedana dnevno primale Kineret (25 ispitanika) ili placebo (25 ispitanika).
It may contain some translucent-to-white particles of protein.
Može sadržavati neke prozirne do bijele čestice bjelančevina.
Uncommon side effects (may affect up to 1 in 100 people): - Serious allergic reactions including swelling of the face, tongue or throat, trouble swallowing or breathing, suddenly feeling fast pulse or sweating and itchy skin or rash.
- Ozbiljne alergijske reakcije uključujući oticanje lica, jezika ili grla, poteškoće u gutanju ili disanju, iznenadni osjećaj ubrzanog pulsa ili znojenje te svrbež kože ili osip.
The patient reminder card shall contain the following key messages:
• Savjete kako liječiti reakcije na mjestu injiciranja Kartica s podsjetnikom za bolesnike sadržavat će sljedeće ključne obavijesti:
In addition to the evaluation of clinical symptoms and inflammatory markers in severe CAPS, assessments of inflammation of the CNS, including the inner ear (MRI or CT, lumbar puncture, and audiology) and eyes (ophthalmological assessments) are recommended after an initial 3 months of treatment, and thereafter every 6 months, until effective treatment doses have been identified.
CT, lumbalna punkcija i audiologija) i oči (oftalmološki pregled), a potom svakih 6 mjeseci dok se ne utvrdi učinkovita doza liječenja.
• The patient reminder card
• Kartica s podsjetnikom za bolesnike
The absolute bioavailability of anakinra after a 70 mg subcutaneous bolus injection in healthy subjects (n = 11) is 95%.
Apsolutna bioraspoloživost anakinre nakon supkutane bolusne injekcije od 70 mg u zdravih ispitanika
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe Anakinra
Kineret 100 mg/0,67 ml otopina za injekciju u napunjenoj štrcaljki anakinra
There are limited amount of data from the use of anakinra in pregnant women.
Podaci o primjeni anakinre u trudnica su ograničeni.
During post-marketing use case reports of MAS in Kineret treated patients with Still's disease have been received.
Tijekom postmarketinške primjene prijavljeni su slučajevi MAS-a u bolesnika sa Stillovom bolešću liječenih Kineretom.
The adverse reactions table below therefore applies to Kineret treatment of RA, CAPS and Still's disease.
Tablica nuspojava u nastavku se stoga odnosi na liječenje Kineretom bolesnika s RA, CAPS-om i Stillovom bolešću.
Each 0.67 ml graduated pre-filled syringe contains 100 mg of anakinra.
Svaka kalibrirana napunjena štrcaljka od 0,67 ml sadrži 100 mg anakinre.
Adverse reactions data in CAPS patients are based on an open-label study of 43 patients with NOMID/CINCA treated with Kineret for up to 5 years, with a total Kineret exposure of 159.8 patient years.
NOMID/CINCA-om liječenih Kineretom tijekom do 5 godina, pri čemu je ukupna izloženost Kineretu iznosila 159,8 bolesnik godina.
Still's Disease
Maligne bolesti
Sodium hydroxide Water for injections
polisorbat 80, natrijev hidroksid i voda za injekcije.
Only clear, colourless-to-white solutions that may contain some product-related translucent-to-white amorphous particles should be injected.
Smije se injicirati samo bistra, bezbojna do bijela otopina za injekciju koja može sadržavati neke prozirne do bijele amorfne čestice porijeklom od lijeka.
In Kineret treated CAPS patients, there is a risk for disease flares when discontinuing Kineret treatment.
Kineretom postoji rizik od ponovnog izbijanja bolesti nakon prekida liječenja Kineretom.
Injection site reaction Uncommon (≥ 1/1,000 to < 1/100) Rash
Poremećaji imunološkog sustava Manje često (≥ 1/1000 i
• Patient and caregiver information pack
• Informacijski paket za bolesnike i njegovatelje
You should position the syringe in one hand with the needle pointing straight upwards as shown in Figure B. Put your thumb on the plunger rod and push slowly until you see a tiny liquid drop at the tip of the needle.
Štrcaljku stavite u jednu ruku tako da je igla usmjerena ravno prema gore kako je prikazano na slici B.
How to store Kineret
Moguće nuspojave Kako čuvati Kineret
0.67 ml of solution for injection in a graduated pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) and 29 gauge needle.
0,67 ml otopine za injekciju u kalibriranoj napunjenoj štrcaljki (staklo tipa I) sa čepom klipa
At the same time point, 7 of 12 in the Kineret treated group were classified as ACRpedi50 and 5 of 12 as ACRpedi70 responders compared to none in the placebo group.
od 12 bolesnika kao bolesnici s odgovorom ACRpedi70 u usporedbi s nijednim bolesnikom u skupini koja je primala placebo.
Also persistent low-grade fever, weight loss, and persistent cough can be signs of an infection.
Znakovi infekcije također mogu biti stalna blago povišena tjelesna temperatura, gubitak težine i uporan kašalj.
A corresponding decrease in creatinine clearance was seen in the hepatic failure population.
Sukladno tome utvrđen je smanjeni klirens kreatinina u populaciji s dekompenzacijom jetre.
Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of RA, CAPS and Still's disease, respectively.
4.2 Doziranje i način primjene Liječenje Kineretom treba započeti i nadzirati liječnik specijalist iskusan u dijagnosticiranju i liječenju
There may be some translucent-to-white particles of protein in the solution.
U otopini mogu postojati neke prozirne do bijele čestice bjelančevina.
• a pre-filled syringe of Kineret
• vanjski dio nadlaktica
Citric acid, anhydrous Sodium chloride Disodium edetate dihydrate Polysorbate 80
6.1 Popis pomoćnih tvari citratna kiselina, bezvodna natrijev klorid dinatrijev edetat dihidrat polisorbat 80 natrijev hidroksid voda za injekcije
Patients with trisomy 21 seem to be overrepresented.
Čini se da veći udio ovih bolesnika čine bolesnici s trisomijom 21. Nije ustanovljena uzročna povezanost s Kineretom.
Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Kineret je indiciran u odraslih, adolescenata, djece i dojenčadi u dobi od 8 mjeseci i starije s tjelesnom težinom od najmanje 10 kg ili više za liječenje Stillove bolesti, uključujući sistemski juvenilni idiopatski artritis (engl.
- The other ingredients are anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polysorbate 80 and sodium hydroxide and water for injections.
- Drugi sastojci su bezvodna citratna kiselina, natrijev klorid, dinatrijev edetat dihidrat,
Immune system disorders
Neonatal-Onset Multisystem Inflammatory
Your doctor will have to decide if you can still be given Kineret; - if you have a history of increased levels of liver enzymes; - if you require vaccinations.
Liječnik će odlučiti da li još uvijek možete primati Kineret;
In clinical studies in RA patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
U kliničkim ispitivanjima u bolesnika s reumatoidnim artritisom trombocitopenija je prijavljena u 1,9%
Anakinra
Chronic
Very common side effects (may affect more than 1 in 10 people): - Redness, swelling, bruising or itching at the injection site.
- Svrbež kože ili osip Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
Malignancies
Trombocitopenija
Kineret was studied in a single randomized, blinded multi-center trial in 86 patients with polyarticular course JIA (ages 2-17 years) receiving a dose of 1 mg/kg subcutaneously daily, up to a maximum dose of 100 mg.
86 bolesnika s poliartikularnim JIA (dob 2-17 godina) koji su primali dozu od 1 mg/kg dnevno supkutanom injekcijom, do maksimalne doze od 100 mg. 50 bolesnika u kojih je postignut klinički odgovor nakon 12 tjedana otvorene, početne faze ispitivanja randomizirani su u skupine koje su daljnjih
This is a type of cytokine (an immunosuppressive agent) that is used to treat: - Rheumatoid Arthritis (RA) - Cryopyrin-Associated Periodic Syndromes (CAPS) which includes the following autoinflammatory diseases: - Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also called Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), - Muckle-Wells Syndrome (MWS), - Familial Cold Autoinflammatory Syndrome (FCAS) - Still´s disease including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD)
Neonatal-Onset Multisystem Inflammatory Disease - NOMID) ili takozvani kronični infantilni neurološki, kutani i zglobni sindrom
Pull straight as shown in Figure A. Do not touch the needle or push the plunger.
Nemojte dodirivati iglu ili gurati klip.
(~35 times the recommended dose in RA) over a 72 hour treatment period.
U ispitivanjima sepse, 1015 bolesnika primilo je Kineret u dozama do 2 mg/kg/sat intravenski (~35 puta više od preporučene doze za bolesnike s RA) tijekom razdoblja liječenja od 72 sata.
The therapeutic response is primarily reflected by reduction in clinical symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.
bol u zglobovima i glavobolja, ali i u razini upalnih markera u serumu (CRP/SAA razine) ili u ponovnom izbijanju bolesti.
The median steady-state dose-normalized anakinra concentration in SJIA patients over 28 weeks was comparable to that observed in RA patients.
SJIA tijekom 28 tjedana bio je usporediv s onim uočenim u bolesnika s RA.
• Contact details of their physician
• Kontakt podatke bolesnikova liječnika
In RA patients the most common and consistently reported treatment-related adverse reactions associated with Kineret were ISRs.
Najčešće i dosljedno prijavljene nuspojave povezane s liječenjem Kineretom u bolesnika s RA bile su reakcije na mjestu primjene (engl.
Hearing and visual acuity did not deteriorate further during anakinra treatment.
Tijekom liječenja anakinrom nije došlo do pogoršanja oštrine sluha i vida.
Hyperlink reference not valid.http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.