natgillin/translations-raw huggingface dataset:
The active substance in Kineret, anakinra, is an immunosuppressive medicine.
Zdravilna učinkovina zdravila Kineret je anakinra, ki je zdravilo za zmanjšanje imunskega odziva.
It blocks the receptors for a chemical messenger in the body called interleukin-1.
Zavira receptorje za kemično sporočilno molekulo telesa, ki se imenuje interlevkin- 1.
This messenger is produced in high levels in patients with rheumatoid arthritis, causing inflammation of the joints and joint damage.
To sporočilno molekulo bolniki z revmatoidnih artritisom tvorijo v velikih količinah, povzroča pa vnetje in poškodbe sklepov.
By attaching to the receptors that interleukin-1 would normally attach itself to, anakinra blocks the activity of interleukin-1, helping to relieve the symptoms of the disease.
Z vezanjem na receptorje, na katere se običajno veže interlevkin- 1, anakinra blokira aktivnost interlevkina- 1 in tako ublaži simptome bolezni.
The active substance in Kineret, anakinra, is a copy of a natural human protein called ‘ human interleukin-1 receptor antagonist’.
Zdravilna učinkovina zdravila Kineret, anakinra, je kopija naravne človeške beljakovine, imenovane „ antagonist človeškega receptorja za interlevkin- 1 ”.
It is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce anakinra.
Proizvaja se z metodo, znano kot „ tehnologija rekombinantne DNK ”, pri kateri bakterije prejmejo gen (DNK), s katerim lahko tvorijo zdravilno učinkovino anakinra.
The replacement anakinra acts in same way as the natural protein.
Nadomestna anakinra deluje na enako kot naravna beljakovina.
The first study included 468 patients, some of whom had taken other medicines for their 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V vseh treh študijah so učinkovitost zdravila Kineret primerjali s placebom 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. disease in the past, and who were given either Kineret on its own or placebo.
(zdravilom brez zdravilne učinkovine).
In the other two studies, the medicines were used as an add-on to existing treatment including methotrexate: one study, which involved 419 patients, used a range of doses of Kineret that depended on the patient’ s weight, and the other study, which involved 501 patients, used Kineret at a fixed dose of 100 mg once a day.
V dveh drugih študijah so zdravilo uporabili kot dodatek k obstoječemu zdravljenju, ki je vključevalo metotreksat: v prvi študiji, ki je vključevala 419 bolnikov, so uporabili različne odmerke zdravila Kineret, ki so bili odvisni od bolnikove telesne mase, v drugi študiji, ki je vključevala 501 bolnika, pa so uporabili fiksni odmerek zdravila Kineret 100 g enkrat dnevno.
In all three studies, the main measure of effectiveness was the number of patients with an improvement in symptoms of at least 20% after six months.
V vseh treh študijah je bilo glavno merilo učinkovitosti število bolnikov z najmanj 20- odstotnim izboljšanjem simptomov po šestih mesecih.
Symptoms were measured by the doctor and the patient using the ‘ American College of Rheumatology ’ score, which includes measurements of the number of painful or tender joints, disease activity, pain, disability and levels of C-reactive protein in the blood (a marker of inflammation).
Simptome so merili zdravnik in bolniki s pomočjo lestvice rezultatov „ Ameriškega kolidža za revmatologijo ”, ki vključuje merjenje števila bolečih ali občutljivih sklepov, aktivnosti bolezni, bolečine, onesposobljenosti in ravni C- reaktivne beljakovine v krvi (znamenje vnetja).
The first study showed that certain doses of Kineret were more effective than placebo in reducing the symptoms of rheumatoid arthritis.
Prva študija je pokazala, da so bili določeni odmerki zdravila Kineret učinkovitejši od placeba pri zmanjševanju simptomov revmatoidnega artritisa.
However, because of the way the study was designed, the results were considered insufficient to support the use of the medicine on its own.
Vendar so bili rezultati te študije zaradi tega, kako je bila študija načrtovana, označeni kot nezadostni za podporo uporabe zdravila kot samostojnega zdravila.
The other two studies showed that Kineret was more effective than placebo when used as an add-on to methotrexate.
Drugi dve študiji sta pokazali, da je bilo zdravilo Kineret učinkovitejše od placeba, če se je uporabljalo kot dodatek metotreksatu.
In the study using a fixed dose of Kineret, 38% of the patients adding Kineret had at least a 20% reduction in symptoms after six months, compared with 22% of those adding placebo.
V študiji, kjer so uporabljali fiksni odmerek zdravila Kineret, je bilo pri 38% bolnikov, ki so kot dodatek prejemali zdravilo Kineret, po šestih mesecih opaženo vsaj 20- odstotno zmanjšanje simptomov, medtem ko je bil pri bolnikih, ki so kot dodatek prejemali placebo, ta delež 22%.
The most common side effects with Kineret (seen in more than 1 patient in 10) are headache and injection site reactions (redness, bruising, pain and inflammation).
Najpogostejši neželeni učinki zdravila Kineret (opaženi pri več kot 1 bolniku od 10) so glavobol in reakcije na mestu injiciranja (rdečina, podplutba, bolečina in vnetje).
For the full list of all side effects reported with Kineret, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kineret, glejte navodilo za uporabo.
Kineret should not be used in people who may be hypersensitive (allergic) to anakinra, to any of the other ingredients, or to proteins produced by Escherichia coli (a type of bacterium).
Zdravila Kineret ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilno učinkovino anakinra, katerokoli drugo sestavino zdravila ali beljakovine, ki jih tvori Escherichia coli (vrsta bakterije).
Kineret should not be used in patients who have severe problems with their kidneys.
Zdravilo Kineret se prav tako ne sme uporabljati pri bolnikih s hudimi težavami z ledvicami.
The use of Kineret with tumour necrosis factor (TNF) antagonists (other medicines used in rheumatoid arthritis) is not recommended.
Uporaba zdravila Kineret z antagonisti faktorja tumorske nekroze (TNF) (druga zdravila, ki se uporabljajo pri revmatoidnem artritisu) ni priporočena.
The Committee for Medicinal Products for Human Use (CHMP) decided that Kineret’ s benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Kineret pri zdravljenju znakov in simptomov revmatoidnega artritisa v kombinaciji z metotreksatom pri bolnikih z nezadostnim odzivom na zgolj metotreksat večji od z njim povezanih tveganj.
The Committee recommended that Kineret be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Kineret odobri dovoljenje za promet.
Other information about Kineret:
Druge informacije o zdravilu Kineret:
The European Commission granted a marketing authorisation valid throughout the European Union for Kineret on 8 March 2002.
Evropska komisija je dovoljenje za promet z zdravilom Kineret, veljavno po vsej Evropski uniji, odobrila dne 8. marca 2002.
The marketing authorisation was renewed on 8 March 2007.
Dovoljenje za promet je bilo obnovljeno dne 8. marca 2007.
The marketing authorisation holder is Biovitrum AB (publ).
Imetnik dovoljenja za promet je družba Biovitrum AB (publ.).
The full EPAR for Kineret can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kineret je na voljo tukaj.
Kineret 100 mg solution for injection in a pre-filled syringe.
Kineret 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi.
Each pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ ml).
Ena napolnjena injekcijska brizga vsebuje 100 mg anakinre * na 0, 67 ml (150 mg/ ml).
* Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.
* Antagonist človeškega receptorja za interlevkin- 1 (r- metHuIL- 1ra), ki ga izdelujejo v celicah Escherichie coli s tehnologijo rekombinantne DNA.
Solution for injection (injection) in a pre-filled syringe.
Raztopina za injiciranje (injekcijo) v napolnjeni injekcijski brizgi.
Clear, colourless-to-white solution for injection that may contain some product-related translucent-to- white amorphous particles.
Bistra, brezbarvna do bela raztopina za injiciranje, ki lahko vsebuje nekaj prosojnih do belih amorfnih delce
Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Kineret je indiciran za zdravljenje znakov in simptomov revmatoidnega artritisa v kombinaciji z metotreksatom pri bolnikih z nezadostnim odzivom na metotreksat sam.
The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection.
Priporočeni odmerek Kinereta je 100 mg, dan enkrat na dan s subkutano injekcijo.
For patient convenience, Kineret is supplied ready for use in a pre-filled syringe.
Da je za bolnika bolj prikladno, je Kineret na voljo pripravljen za uporabo v napolnjeni injekcijski brizgi.
The instructions for use and handling are given in section 6.6.
Navodila za uporabo in ravnanje so podana v poglavju 6. 6.
Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Zdravljenje s Kineretom morajo uvesti in nadzorovati zdravniki specialisti, ki so izkušeni v diagnostiki in zdravljenju revmatoidnega artritisa.
There are insufficient data to recommend the use of Kineret in children and adolescents under 18 years of age.
Na voljo je premalo podatkov, da bi lahko priporočili uporabo Kinereta pri otrocih in mladostnikih, mlajših od 18 let.
2 Hepatic impairment
2 Ledvična okvara
No dosage adjustment is needed for patients with mild renal impairment (CLcr 50 to 80 ml/ minute).
Pri bolnikih z blago ledvično okvaro (CLcr 50 do 80 ml/ minuto) ni potrebno prilagajanje odmerjanja.
In the absence of adequate data, Kineret should be used with caution in patients with moderate renal impairment (CLcr 30 to 50 ml/ minute).
Ker ni na voljo primernih podatkov, je treba pri bolnikih z zmerno ledvično okvaro (CLcr 30 do 50 ml/ minuto) Kineret uporabljati previdno.
Kineret should not be used in patients with severe renal impairment (CLcr < 30 ml/ minute) (see section 4.3).
Kinereta ne smete uporabljati pri bolnikih s hudo ledvično okvaro (CLcr < 30 ml/ minuto) (glejte poglavje 4. 3).
Hypersensitivity to the active substance, any of the excipients or to E. coli derived proteins.
Preobčutljivost za zdravilno učinkovino, katerokoli pomožno snov ali za beljakovine, ki izvirajo iz E. coli.
Kineret should not be used in patients with severe renal impairment (CLcr < 30 ml/ minute) (see section 4.2).
Kinereta ne smete uporabljati pri bolnikih s hudo ledvično okvaro (CLcr < 30 ml/ minuto) (glejte poglavje 4. 2).
Allergic reactions associated with administration of Kineret during clinical trials were rare.
Alergijske reakcije, povezane z uporabo Kinereta med kliničnimi preskušanji, so bile redke.
If a severe allergic reaction occurs, administration of Kineret should be discontinued and appropriate treatment initiated.
Če se pojavi huda alergijska reakcija, je treba prekiniti uporabo Kinereta in uvesti ustrezno zdravljenje.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suh naravni kavčuk (derivat lateksa), ki lahko povzroči alergijske reakcije.
Kineret has been associated with an increased incidence of serious infections (1.8%) vs. placebo (0.7%).
Kineret povezujejo z zvečano incidenco hudih okužb (1, 8%) proti placebu (0, 7%).
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%).
Pri majhnem številu bolnikov z astmo je bila incidenca resnih okužb večja pri bolnikih, ki so dobivali Kineret (4, 5%), kot pri tistih, ki so dobivali placebo (0%).
The safety and efficacy of Kineret in patients with chronic infections have not been evaluated.
Varnosti in učinkovitosti Kinereta pri bolnikih s kroničnimi okužbami niso ovrednotili.
Physicians should exercise caution when administering Kineret to patients with a history of recurring infections or with underlying conditions which may predispose them to infections.
Pri predpisovanju Kinereta bolnikom z anamnezo ponavljajočih se okužb ali z osnovnimi boleznimi, ki bi jih lahko naredile dovzetne za okužbe, morajo biti zdravniki previdni.
Administration of Kineret was associated with neutropenia (ANC < 1.5 x 109/ l) in 2.4% of patients compared with 0.4% of placebo patients.
Uporaba Kinereta je bila povezana z nevtropenijo (ANC < 1, 5 x 109/ l) pri 2, 4% bolnikov v primerjavi z 0, 4% bolnikov, ki so dobivali placebo.
Kineret treatment should not be initiated in patients with neutropenia (ANC < 1.5 x 109/ l).
Pri bolnikih z nevtropenijo (ANC < 1, 5 x 109/ l) ne smemo uvesti zdravljenja s Kineretom.
It is recommended that neutrophil counts be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly during the first 6 months of treatment and quarterly hereafter.
Priporočajo določanje nevtrofilcev pred uvedbo zdravljenja s Kineretom, med zdravljenjem s Kineretom pa prvih šest mesecev vsak mesec, nato pa na četrt leta.
In patients who become neutropenic (ANC < 1.5 x 109/ l) the ANC should be monitored closely and Kineret treatment should be discontinued.
Pri bolnikih, ki postanejo nevtropenični (ANC < 1, 5 x 109/ l), je treba skrbno spremljati ANC, zdravljenje s Kineretom pa je treba prekiniti.
The impact of treatment with Kineret on pre-existing malignancy has not been studied.
V kliničnem preskušanju (n = 126), kontroliranem s placebom, so sočasno s Kineretom uporabili toksoid tetanusa/ davice.
Therefore the use of Kineret in patients with pre-existing malignancy is not recommended.
Pri tem med skupino, ki je dobivala Kineret, in tisto, ki je dobivala placebo, niso ugotovili razlik v odzivu protiteles proti tetanusu.
3 Vaccinations
3 O učinkih živih cepiv in o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, ki so dobivali Kineret, ni nobenih podatkov.
Therefore, live vaccines should not be given concurrently with Kineret.
Živih cepiv zato ne smete uporabljati sočasno s Kineretom.
A total of 635 patients ≥ 65 years of age, including 131 patients ≥ 75 years of age, were studied in clinical trials.
V kliničnih preskušanjih so proučili skupaj 635 bolnikov, starih 65 let ali več, med njimi je bilo 131 bolnikov, starih 75 let ali več.
No overall differences in safety or effectiveness were observed between these patients and younger patients.
V celoti gledano med temi bolniki in mlajšimi bolniki ni razlik glede varnosti ali učinkovitosti.
Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Ker je v starejši populaciji na splošno večja incidenca okužb, morate biti pri zdravljenju starejših bolnikov previdni.
Concurrent Kineret and TNF antagonist treatment
Sočasno zdravljenje s Kineretom in antagonisti TNF
Concurrent administration of Kineret and etanercept has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
Sočasno uporabo Kinereta in etanercepta povezujejo z večjim tveganjem hudih okužb in nevtropenije v primerjavi z uporabo etanercepta samega.
The concurrent administration of Kineret and etanercept or other TNF antagonists is not recommended (see section 4.5).
Sočasna uporaba Kinereta in etanercepta ali drugih antagonistov TNF ni priporočljiva (glejte poglavje 4. 5).
Interactions between Kineret and other medicinal products have not been investigated in formal studies.
Interakcij med Kineretom in drugimi zdravili niso raziskovali v uradnih študijah.
In clinical trials, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory drugs, corticosteroids, and DMARDs) have not been observed.
V kliničnih preskušanjih niso opazili interakcij med Kineretom in drugimi zdravili (vključno z nesteroidnimi protivnetnimi zdravili, kortikosteroidi in DMARD).
In a clinical trial with patients receiving background methotrexate, patients treated with Kineret and etanercept were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept alone and higher than observed in previous trials where Kineret was used alone.
V kliničnem preskušanju bolnikov, ki so kot osnovno zdravilo dobivali metotreksat, so pri bolnikih, zdravljenih s Kineretom in etanerceptom, opazili večjo pogostost hudih okužb (7%) in nevtropenije kot pri bolnikih, zdravljenih samo z etanerceptom, in tudi večjo kot v prejšnjih preskušanjih, v katerih so uporabljali samo Kineret.
Concurrent Kineret and etanercept treatment has not demonstrated increased clinical benefit.
Sočasno zdravljenje s Kineretom in etanerceptom ni pokazalo zvečane klinične koristnosti.
The concurrent use of Kineret with etanercept or any other TNF antagonist is not recommended (see section 4.4).
Kinereta ni priporočljivo uporabljati sočasno z etanerceptom ali kakšnim drugim antagonistom TNF (glejte poglavje 4. 4).
For information on vaccinations see section 4.4.
Za informacije o vakcinacijah glejte poglavje 4. 4.
There are no adequate data from the use of Kineret in pregnant women.
Ni zadostnih podatkov o uporabi Kinereta pri nosečnicah.
The use of Kineret in pregnant women is not recommended.
Uporabe Kinereta pri nosečnicah ne priporočajo.
4 Women of child-bearing potential must use effective contraception during treatment.
Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
The use of Kineret in women who are breast-feeding is not recommended.
Uporabe Kinereta pri doječih materah ne priporočajo.
No studies on the effects of Kineret on the ability to drive and use machines have been performed.
Študije o vplivu Kinereta na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
In all placebo-controlled studies, the most frequently reported adverse event with Kineret was injection site reaction (ISRs), which was mild to moderate in the majority of patients.
V vseh s placebom kontroliranih študijah je bil neželeni učinek pri Kineretu, o katerem so najpogosteje poročali, reakcija na mestu injiciranja (ISR – » injection site reaction «), ki je bila pri večini bolnikov blaga do zmerna.
The most common reason for withdrawal from study in Kineret-treated patients is injection site reaction.
Najpogostejši razlog za izstop bolnikov, zdravljenih s Kineretom, iz študije je bila reakcija na mestu injiciranja.
The subject incidence of serious adverse events at the recommended dose of Kineret (100 mg/ day) is comparable with placebo (7.1% compared with 6.5% in the placebo group).
Incidenca resnih neželenih učinkov pri priporočenem odmerku Kinereta (100 mg/ dan) je primerljiva s placebom (7, 1% v primerjavi s 6, 5% v skupini s placebom).
0.7%).
Incidenca hudih okužb je bila večja pri bolnikih, zdravljenih s Kineretom, kot pri bolnikih, ki so dobivali placebo (1, 8% proti 0, 7%).
Neutrophil decreases occurred more frequently in patients receiving Kineret compared with placebo.
Nevtrofilci so se znižali pogosteje pri bolnikih, ki so dobivali Kineret, kot pri tistih s placebom.
MedDRA Organ System Blood and lymphatic system disorders
Organski sistem bolezni krvi in limfatičnega sistema bolezni živčevja bolezni kože in podkožja infekcijske in parazitske bolezni
Frequency Common (≥ 1/ 100 to < 1/ 10)
Pogostnost pogost (≥ 1/ 100 do < 1/ 10) zelo pogost (≥ 1/ 10) zelo pogost (≥ 1/ 10) pogost (≥ 1/ 100 do < 1/ 10)
Nervous system disorders Skin and subcutaneous tissue disorders
Neželeni učinek nevtropenija glavobol reakcija na mestu injiciranja resne okužbe, zaradi katerih je bil potreben sprejem v bolnišnico
The most common and consistently reported treatment-related adverse events associated with Kineret were ISRs.
Najpogostejši neželeni učinek, ki je povezan z zdravljenjem in o katerem so pri Kineretu najdosledneje poročali, je ISR.
The majority (95%) of ISRs were reported as mild to moderate.
O večini (95%) ISR so poročali kot o blagih do zmernih.
At a dose of 100 mg/ day, 71% of patients developed an ISR compared to 28% of the placebo treated patients, which was typically reported within the first 4 weeks of therapy.
O ISR so običajno poročali v prvih 4 tednih zdravljenja.
The median duration of the above mentioned typical symptoms was 14 to 28 days.
Mediana trajanja zgoraj omenjenih tipičnih simptomov je bila 14 do 28 dni.
The incidence of serious infections in the studies conducted at the recommended dose (100 mg/ day) was 1.8% in Kineret treated patients and 0.7% in placebo-treated patients.
Incidenca hudih okužb v študijah, opravljenih s priporočenim odmerkom (100 mg/ dan) je bila 1, 8% pri bolnikih zdravljenih s Kineretom in 0, 7% pri bolnikih, ki so dobivali placebo.
In observations up to 3 years, the serious infection rate remained stable over time.
V opazovanjih, ki so trajala do 3 leta, je bil delež resnih okužb skozi čas stalen.
Most patients continued on study drug after the infection resolved.
Potem ko se je okužba pozdravila, je večina bolnikov nadaljevala s proučevanim zdravilom.
There were no on-study deaths due to serious infectious episodes.
Zaradi epizod hudih okužb ni bilo med študijo nobenega smrtnega primera.
In clinical studies and post-marketing experience, rare cases of opportunistic infections have been observed and included fungal, mycobacterial, bacterial, and viral pathogens.
V kliničnih študijah in v pomarketinškem obdobju so zabeležili redke primere oportunističnih okužb, ki so vključevale glivične, mikobakterijske, bakterijske in virusne patogene.
Infections have been noted in all organ systems and have been reported in patients receiving Kineret alone or in combination with immunosuppressive agents.
Okužbe so opažali na vseh organskih sistemih ter so bile opisane pri bolnikih, ki so dobivali Kineret sam ali v kombinaciji z imunosupresivnimi zdravili.
5 Neutropenia
Nevtropenija
In placebo-controlled studies with Kineret, treatment was associated with small reductions in the mean values for total white blood count and absolute neutrophil count (ANC).
V študijah s Kineretom, kontroliranih s placebom, je bilo zdravljenje povezano z majhnim znižanjem srednjih vrednosti vseh belih krvničk in absolutnega števila nevtrofilcev (ANC – » absolute neutrophil bcount «).
Neutropenia (ANC < 1.5 x 109/ l) was reported in 2.4% patients receiving Kineret compared with 0.4% of placebo patients.
O nevtropeniji (ANC < 1, 5 x 109/ l) so poročali pri 2, 4% bolnikov, ki so prejemali Kineret, v primerjavi z 0, 4% pri bolnikih s placebom.
Rheumatoid arthritis (RA) patients may be at a higher risk (on average 2-3 fold) for the development of lymphoma.
Bolnike z revmatoidnim artritisom (RA) bolj (v povprečju 2 - do 3- krat bolj) ogroža pojav limfomov.
In clinical trials, whilst patients treated with Kineret had a higher incidence of lymphoma than the expected rate in the general population, this rate is consistent with rates reported in general for RA patients.
V kliničnih preskušanjih pri bolnikih, zdravljenih s Kineretom, je bila incidenca limfomov sicer večja kot je pričakovana v splošni populaciji, se je pa delež skladal z deležem, ki ga na splošno navajajo pri bolnikih z RA.
In clinical trials, the crude incidence rate of malignancy was the same in the Kineret-treated patients and the placebo-treated patients and did not differ from that in the general population.
V kliničnih študijah je bila sama incidenca malignih bolezni je pri bolnikih, ki so dobivali Kineret in placebo, enaka in se ni razlikovala od tiste v splošni populaciji.