natgillin/translations-raw huggingface dataset:
(~35 times the recommended dose in RA) over a 72 hour treatment period.
(~35-krat priporočeni odmerek pri RA) skozi 72 urno obdobje zdravljenja.
Pharmacokinetic parameters were not substantially different from healthy volunteers, other than a decrease in clearance of approximately 30% in comparison with data from a study with healthy volunteers.
Farmakokinetični parametri niso bili bistveno drugačni kot pri zdravih prostovoljcih, razen zmanjšanja očistka za približno 30 % v primerjavi s podatki iz študije z zdravimi prostovoljci.
The presence of these particles does not affect the quality of the product.
Prisotnost teh delcev ne vpliva na kakovost zdravila.
No dose adjustment is required based on age or gender.
Prilagoditev odmerka na podlagi starosti ali spola ni potrebna.
Do not warm Kineret in any other way (for example, do not warm it in a microwave or in hot water).
Ne ogrevajte zdravila Kineret kako drugače (ne grejte ga npr. v mikrovalovni pečici ali vroči vodi).
Distribution into the cerebrospinal fluid has been demonstrated.
Dokazana je bila porazdelitev v cerebrospinalno tekočino.
Anakinra is produced by DNA technology using the micro-organism E. coli.
Anakinra je izdelana s tehnologijo DNA z uporabo mikroorganizma E. coli.
Treatment with Kineret resulted in normalization of body temperature in 18 of 20 patients.
Zdravljenje z zdravilom Kineret je povzročilo normalizacijo telesne temperature pri 18 od 20 bolnikov.
No data are available on LDL or HDL cholesterol.
Podatki o LDL in HDL holesterolu niso na voljo.
This was not associated with any clinically significant effects on pharmacokinetics, efficacy, or safety.
To ni bilo povezano s klinično pomembnimi učinki na farmakokinetiko, učinkovitost ali varnost.
Do not reuse a syringe as this can cause infection.
Ne uporabljajte brizge ponovno, ker lahko to povzroči okužbo.
• A description of the signs of serious infections
• opis znakov resnih okužb.
Your doctor will tell you the dose that you need or whether you need a dose higher than 100 mg.
Zdravnik vam bo povedal, kateri odmerek potrebujete in če potrebujete odmerek, višji od 100 mg.
The majority (95%) of ISRs were reported as mild to moderate.
O večini (95 %) ISR so poročali kot o blagih do zmernih.
During the 5-year study 14 patients (32.6%) reported 24 serious events.
V 5-letni študiji je 14 bolnikov (32,6 %) poročalo o 24 resnih dogodkih.
This results in harmful effects leading to inflammation, causing the symptoms of the disease.
Zaradi tega pride do škodljivih učinkov, ki vodijo do vnetja in povzročijo simptome bolezni.
None of these patients had serious infections associated with the neutropenia.
Nobeden od teh bolnikov ni imel hudih okužb, povezanih z nevtropenijo.
Do not use Kineret if you think it has been frozen.
Ne uporabljajte zdravila Kineret, če mislite, da je bilo zamrznjeno.
Check the appearance of Kineret.
Preverite izgled zdravila Kineret.
Rheumatoid Arthritis (RA)
Revmatoidni artritis (RA)
The plasma concentration decreased with no discernible distribution phase and the terminal half-life ranged from 4 to 6 hours.
Koncentracije v plazmi so se zmanjšale brez opazne porazdelitvene faze in končni razpolovni čas je bil od 4 do 6 ur.
Posology and administration are the same as for adults 18 to 64 years of age.
Odmerjanje in način uporabe sta enaka kot pri odraslih, starih od 18 do 64 let.
However, you should contact your doctor, nurse or pharmacist if this does happen.
Vendar morate stopiti v stik s svojim zdravnikom, medicinsko sestro ali farmacevtom, če se to zgodi.
The main objectives of the programme are to provide information on the method of administration, raise awareness on the potential risk of macrophage activation syndrome (MAS) and on the potential risk of serious infections.
Glavni cilji programa so zagotovitev informacij o načinu uporabe, povečanje ozaveščenosti o možnem tveganju sindroma aktivacije makrofagov (MAS) in o možnem tveganju resnih okužb.
- CAPS: Kineret is not recommended for children younger than 8 months of age because there is no data in this age group.
- CAPS: Zdravilo Kineret ni priporočljivo za otroke, mlajše od 8 mesecev, ker ni podatkov za to starostno skupino.
The dose should be administered at approximately the same time each day.
Odmerek je treba dati vsak dan približno ob istem času.
One out of the 15 patients discontinued due to ISRs.
Eden od 15 bolnikov je prekinil zdravljenje zaradi ISR.
This could mean that the doses of some other medicines, e.g. warfarin or phenytoin, have to be adjusted.
To lahko pomeni, da bo treba prilagoditi odmerek nekaterih drugih zdravil, npr. varfarina ali fenitoina.
With the exception of infections and related symptoms that were more frequently reported in patients <2 years of age, the safety profile was similar in all paediatric age groups.
Razen okužb in povezanih simptomov, o katerih so pogosteje poročali pri bolnikih, starih do < 2 leti, je bil varnostni profil podoben v vseh pediatričnih starostnih skupinah.
- RA: Use of Kineret in children and adolescents with Rheumatoid Arthritis has not been fully investigated and therefore cannot be recommended.
- RA: Uporaba zdravila Kineret pri otrocih in mladostnikih z revmatoidnim artritisom ni bila povsem raziskana, zato je ni mogoče priporočiti.
What Kineret is and what it is used for
Kaj je zdravilo Kineret in za kaj ga uporabljamo
EU/1/02/203/005 - 1-pack EU/1/02/203/006 - 7-pack EU/1/02/203/007 - 28-pack
EU/1/02/203/005 - pakiranje po 1 EU/1/02/203/006 - pakiranje po 7 EU/1/02/203/007 - pakiranje po 28
No data are available in children under the age of 8 months.
Podatkov za otroke, mlajše od 8 mesecev, ni na voljo.
You will need to give yourself or your child an injection at the same time every day.
Injekcijo boste morali dati sebi ali svojemu otroku vsak dan ob istem času.
Accordingly, the decrease in clearance is most likely explained by a decrease in renal function in this population.
V skladu s tem se lahko zmanjšanje očistka najverjetneje pojasni z zmanjšanjem ledvične funkcije pri tej populaciji.
The risk for developing MAS is increased if you have an infection or if your Still's disease symptoms are poorly controlled.
Tveganje za razvoj MAS je večje, če imate okužbo ali če so vaši simptomi Stillove bolezni slabo nadzorovani.
For information on vaccinations see section 4.4.
Za informacije o vakcinacijah glejte poglavje 4.4.
When you start taking Kineret the chronic inflammation in your body will decrease.
Ko boste začeli jemati zdravilo Kineret, se bo kronično vnetje v vašem telesu zmanjšalo.
RA: The efficacy of Kineret in children with RA (JIA) aged 0 to 18 years has not been established.
RA: Učinkovitost zdravila Kineret pri otrocih z RA (JIA), starih od 0 do 18 let, ni bila dokazana.
Placebo treatment (n=213) resulted in a decrease of approximately 2.2% in total cholesterol levels at week 2 and 2.3% at week 24.
Zdravljenje s placebom (n = 213) je povzročilo zmanjšanje skupne ravni holesterola za približno 2,2 % v drugem tednu in 2,3 % v 24. tednu.
RA: No dose adjustment is required.
RA: Prilagoditev odmerka ni potrebna.
Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating elderly patients.
Ker je v starejši populaciji na splošno večja incidenca okužb, morate biti pri zdravljenju starejših bolnikov previdni.
Upon start or end of Kineret treatment in patients on these types of medicinal products, it may be relevant to consider therapeutic monitoring of the effect or concentration of these products and the individual dose of the medicinal product may need to be adjusted.
Po začetku ali koncu zdravljenja z zdravilom Kineret pri bolnikih, ki se zdravijo s temi vrstami zdravil, je morda ustrezno razmisliti o terapevtskem spremljanju učinka ali koncentracije teh zdravil in morebitni potrebi po prilagoditvi odmerka zdravila.
It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby.
Pomembno je, da zdravniku poveste, da ste noseči, menite, da bi lahko bili noseči, ali če nameravate zanositi.
Cytokines are proteins made by your body that co-ordinate communication between cells and help control cell activity.
Citokini so beljakovine, ki jih izdeluje vaše telo za uravnavanje komuniciranja med celicami in kot pomoč pri kontroli celične aktivnost.
Maintenance dose in severe CAPS (MWS and NOMID/CINCA)
Vzdrževalni odmerek pri težkih oblikah CAPS (MWS in NOMID/CINCA)
• The importance of explaining the use of the syringe and correct injection technique to patients and/or caregivers
• pomembnost obrazložitve uporabe injekcijske brizge in pravilne tehnike injiciranja bolnikom in/ali skrbnikom,
Do not try to inject yourself if you have not been trained.
Ne poskušajte si sami dajati injekcij, če vas tega še niso naučili.
The most suitable places to inject yourself or your child are (See Figure D):
Najprimernejša mesta, kamor boste dali injekcijo sebi ali vašemu otroku (glejte sliko D)
Your doctor will discuss with you the potential risks of taking Kineret during pregnancy.
Vaš zdravnik vam bo razložil morebitna tveganja zaradi jemanja zdravila Kineret med nosečnostjo.
Turn the syringe so that the needle is now pointing downwards.
Obrnite brizgo tako, da je igla zdaj obrnjena navzdol.
Your doctor may decide that it would be more convenient for you to inject Kineret yourself.
Vaš zdravnik bo morda odločil, da bo za vas primerneje, če si boste zdravilo Kineret injicirali sami.
• the abdomen (except for the area around the navel)
• trebuh (razen predela okrog popka)
Immediately discard the needle cover.
Takoj zavrzite pokrovček igle.
Long-term studies have not been performed to evaluate the carcinogenic potential of anakinra.
Dolgoročnih študij za ovrednotenje kancerogenega potenciala anakinre niso opravili.
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 ves čas stalen.
The risk may be increased in patients with Down's syndrome (trisomy 21).
Tveganje je lahko večje pri bolnikih z Downovim sindromom (trisomijo 21).
These study data are insufficient to demonstrate efficacy and, therefore, Kineret is not recommended for paediatric use in JIA.
Podatki iz te študije ne zadoščajo za dokaz učinkovitosti in zato se zdravilo Kineret ne priporoča za pediatrično uporabo pri JIA.
Check the expiry date on the pre-filled syringe label (EXP).
Preverite datum izteka roka uporabnosti na nalepki napolnjene injekcijske brizge („EXP“).
- if you are allergic to anakinra or any of the other ingredients of this medicine, listed in section 6; - if you are allergic to other products that are produced by DNA technology using the micro organism E. coli; - if you have neutropenia (low white blood cell count) determined after a blood test.
če ste alergični na anakinro ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če ste alergični na druga zdravila, izdelana s tehnologijo DNA z uporabo mikroorganizma E. coli; če imate nevtropenijo (nizko število belih krvnih celic), ugotovljeno po preiskavi krvi.
Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25 °C) it must either be used within 12 hours or disposed of.
Ko injekcijsko brizgo vzamete iz hladilnika in le-ta doseže sobno temperaturo (do 25 °C), jo morate v 12 urah bodisi porabiti ali zavreči.
In children with inadequate response the dose can be escalated up to 4 mg/kg/day.
Pri otrocih z nezadostnim odzivom se odmerek lahko poviša na 4 mg/kg/dan.
Less than 2.5% of the administered dose of Kineret was removed by hemodialysis or continuous ambulatory peritoneal dialysis.
Manj kot 2,5 % danega odmerka zdravila Kineret je bilo odstranjenega s hemodializo ali stalno ambulantno peritonealno dializo.
If you are not able to set the correct dose, dispose of the syringe and use a new one.
Če ne morete nastaviti pravilnega odmerka, odvrzite injekcijsko brizgo in uporabite novo.
However, after adjusting for creatinine clearance and body weight, gender and age were not significant factors for mean plasma clearance.
Vendar po prilagoditvi na očistek kreatinina in telesno maso spol in starost nista bila pomembna dejavnika za srednji plazemski očistek.
• If you had a dose lower than 100 mg you will have been told to eject liquid from the syringe onto a gauze or tissue.
• Če imate odmerek, manjši od 100 mg, vam je bilo naročeno, da izbrizgate tekočino iz brizge v gazo ali robček.
For instructions on how to inject yourself or your child with Kineret, please read the “Instructions for preparing and giving an injection of Kineret” section at the end of this leaflet.
Glede navodil, kako zdravilo Kineret injicirate sebi ali svojemu otroku, preberite poglavje „Navodila za pripravo in dajanje injekcije zdravila Kineret“ na koncu tega navodila.
None of the syringe or needle shield components are made with natural rubber latex.
Nobena izmed komponent brizge ali ščita igle ni izdelana iz lateksa iz naravne gume.
Normally, your body produces a protein that blocks the harmful effects of interleukin-1.
Normalno vaše telo izdeluje beljakovino, ki blokira škodljive učinke interlevkina-1.
Interactions between Kineret and other medicinal products have not been investigated in formal studies.
Interakcij med zdravilom Kineret in drugimi zdravili niso raziskovali v uradnih študijah.
If you forget to use Kineret
Če ste pozabili uporabiti zdravilo Kineret
Dose increases may become necessary within 1-2 months based on therapeutic response.
Na podlagi terapevtskega odziva bo morda v 1-2 mesecih treba povečati odmerek.
Response to treatment should be evaluated after 1 month: In case of persistent systemic manifestations dose may be adjusted in children or continued treatment with Kineret should be reconsidered by the treating physician.
Odziv na zdravljenje je treba oceniti po 1 mesecu: V primeru vztrajnih sistemskih manifestacij je odmerek pri otrocih mogoče prilagoditi oziroma lahko lečeči zdravnik ponovno razmisli o nadaljevanju zdravljenja z zdravilom Kineret.
- Elevated levels of liver enzymes determined after a blood test.
- zvišane vrednosti jetrnih encimov, ugotovljene po preiskavi krvi.
How to prepare a 100 mg dose
Kako pripraviti odmerek 100 mg
Immunogenicity See section 4.8.
Imunogenost Glejte poglavje 4.8.
What Kineret is and what it is used for What you need to know before you use Kineret How to use Kineret
Kaj je zdravilo Kineret in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Kineret Kako uporabljati zdravilo Kineret
Before you inject Kineret you must do the following:
Pred injiciranjem zdravila Kineret morate narediti naslednje:
The safety of Kineret in individuals with latent tuberculosis is unknown.
Varnost zdravila Kineret pri posameznikih z latentno tuberkulozo ni znana.
At the end of this period, the product must not be put back in the refrigerator and must be disposed of.
Po koncu hranjenja izven hladilnika se zdravila ne sme ponovno shraniti v hladilnik, ampak ga je treba zavreči.
The adverse event profile from these studies show no overall difference from that seen in the rheumatoid arthritis studies.
Profil neželenih učinkov iz teh študij v celoti gledano ne kaže razlik od tistega, ki so ga ugotovili v študijah revmatoidnega artritisa.
These symptoms are generally mild to moderate and are more common at the start of your treatment.
Ti učinki so v splošnem blagi do zmerni in pogostejši na začetku zdravljenja;
Kineret was temporarily stopped in one patient, all other patients continued Kineret treatment during the infections.
Zdravilo Kineret je bilo začasno ustavljeno pri enem bolniku, vsi drugi bolniki so med okužbami nadaljevali zdravljenje z zdravilom Kineret.
The usual maintenance dose in severe CAPS is 3-4 mg/kg/day, which can be adjusted to a maximum of 8 mg/kg/day.
Običajni vzdrževalni odmerek pri težkih oblikah CAPS je 3-4 mg/kg/dan in se lahko prilagodi do največ 8 mg/kg/dan.
At 1 year follow-up, 18 of 20 patients showed at least an adapted ACRpedi 70 response, and 17 of 20 patients reached an adapted ACRpedi 90 response as well as inactive disease.
Ob kontroli po 1 letu se je pri 18 od 20 bolnikov pokazal vsaj prilagojeni odziv ACRpedi 70, 17 od 20 bolnikov pa je doseglo tako prilagojeni odziv ACRpedi 90, kot tudi neaktivno bolezen.
The majority of CAPS patients in Study 03-AR-0298 developed anakinra anti-drug antibodies.
Pri večini bolnikov s CAPS v študiji 03-AR-0298 so se razvila protitelesa proti zdravilu anakinra.
The occurrence of antibodies was typically transient and not associated with clinical adverse reactions or diminished efficacy.
Pojav protiteles je bil praviloma prehoden in ni bil povezan s kliničnimi neželenimi učinki ali manjšo učinkovitostjo.
The MAH shall ensure that in each Member State where Kineret is marketed, all healthcare professionals and patients/caregivers who are expected to prescribe or use Kineret have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici, v kateri se zdravilo Kineret trži, zagotoviti, da vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Kineret, prejmejo naslednji paket izobraževalnih gradiv:
Routine testing of hepatic enzymes during the first month should be considered, especially if the patient has pre-disposing factors or develops symptoms indicating liver dysfunction.
Treba je razmisliti o rutinskem testiranju jetrnih encimov v prvem mesecu, zlasti če ima bolnik predispozicijske dejavnike ali se pri njem razvijejo simptomi, ki kažejo na motnje v delovanju jeter.
You should try to have the injection at the same time each day.
Poskusite si dati injekcijo vsak dan ob istem času.
Thus, it may be expected that for an IL-1 receptor antagonist, such as anakinra, the formation of CYP450 enzymes could be normalized during treatment.
Tako je mogoče pričakovati, da se bo pri antagonistih receptorjev IL-1, kot je anakinra, nastajanje encimov CYP450 med zdravljenjem lahko normaliziralo.
Medicines called tumour necrosis factor (TNF-α) inhibitors, such as etanercept should not be used with Kineret because this may increase the risk of infections.
Zdravila, imenovana zaviralci tumorje nekrotizirajočega faktorja (TNF-α), kot npr. etanercept, se ne smejo uporabljati z zdravilom Kineret, ker lahko to poveča tveganje za okužbo.
Eleven serious events in 4 (9.3%) patients were considered related to Kineret.
Enajst resnih dogodkov pri 4 (9,3 %) bolnikih je bilo povezanih z zdravilom Kineret.
It is important that you do not try to give yourself or your child the injection unless you have received training from a doctor, nurse or pharmacist.
Pomembno je, da ne poskušate dajati injekcij sebi ali svojemu otroku, dokler vas tega ne nauči zdravnik, medicinska sestra ali farmacevt.
If you have forgotten to take a dose of Kineret, you should contact your doctor to discuss when you should take the next dose.
Če ste si pozabili vbrizgati odmerek zdravila Kineret, se posvetujte z zdravnikom glede tega, kdaj si boste injicirali naslednji odmerek.
During an open-label extension phase, switching or add-on treatment with the comparator drug was possible if improvement did not occur within 24 weeks.
Med odprto podaljšano fazo je bilo mogoče preiti na primerjalno zdravilo ali ga uvesti kot dodatno zdravilo, če v 24 tednih ni prišlo do izboljšanja.
Kineret is for patients whose response to methotrexate on its own is not good enough to control the rheumatoid arthritis.
Zdravilo Kineret je namenjeno bolnikom, katerih odziv na metotreksat sam ni dovolj dober, da bi obvladal revmatoidni artritis.
• The early signs indicative of MAS
• zgodnje znake, ki so značilni za MAS,
Furthermore, the overall incidence of malignancies was not increased during 3 years of patient exposure to Kineret.
Poleg tega se celotna incidenca malignomov v 3 letih izpostavljenosti zdravilu Kineret ni povečala.
The recommended dose is either 20 to 90 mg or 100 mg.
Priporočeni odmerek je bodisi od 20 do 90 mg bodisi 100 mg.
INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF KINERET
NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA KINERET
Take your Kineret pre-filled syringe out of the refrigerator.
Vzemite napolnjeno injekcijsko brizgo zdravila Kineret iz hladilnika.
A formal toxicologic and toxicokinetic interaction study in rats revealed no evidence that Kineret alters the toxicologic or pharmacokinetic profile of methotrexate.
Uradna študija o toksikoloških in toksikokinetičnih interakcijah pri podganah ni razkrila dokazov, da zdravilo Kineret spreminja toksikološki ali farmakokinetični profil metotreksata.
Maximal clinical response was generally seen within 12 weeks after starting treatment.
Največji klinični odziv je bil običajno viden v obdobju prvih 12 tednov po začetku zdravljenja.
• Information on macrophage activation syndrome (MAS) in patients receiving the product for the treatment of Still's disease
• podatke o sindromu aktivacije makrofagov (MAS) pri bolnikih, ki zdravilo prejemajo za zdravljenje Stillove bolezni,
Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC03
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci interlevkina, oznaka ATC: L04AC03
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 zdravila Kineret in uvesti ustrezno zdravljenje.
For more information on neutropenia see section 4.8.
Za več informacij o nevtropeniji glejte poglavje 4.8.
The majority of these reactions were maculopapular or urticarial rashes.
Večina teh reakcij je bila makulopapuloznih ali urtikarijskih izpuščajev.
Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI).
Anakinra nevtralizira biološko aktivnost interlevkina-1α IL-1α in interlevkina-1β IL-1β s kompetitivno inhibicijo njune vezave na receptor za interlevkin-1 tipa I (IL-1RI).
A similar pattern was seen after 24 weeks Kineret treatment.
Podoben vzorec je bilo opaziti 24 tednov po zdravljenju z zdravilom Kineret.
In clinical studies transient elevations of liver enzymes have been seen.
V kliničnih študijah so opazili prehodna zvišanja vrednosti jetrnih encimov.
There have been reports of tuberculosis in patients receiving several biological anti-inflammatory treatment regimens.
Poročali so o tuberkulozi pri bolnikih, ki so bili deležni različnih bioloških protivnetnih programov zdravljenja.
• Patient identification
• identifikacijo bolnika,
When patients are clinically well-controlled, CNS and ophthalmological monitoring may be conducted yearly.
Ko je bolezen pri bolnikih klinično dobro urejena, se lahko spremljanje CŽS in oftalmološki pregledi izvajajo enkrat letno.
In a standard battery of tests designed to identify hazards with respect to DNA, anakinra did not induce bacterial or mammalian cell gene mutations.
V standardni testni bateriji, namenjeni identifikaciji nevarnosti glede DNA, anakinra ni povzročila genskih mutacij v bakterijskih ali sesalskih celicah.
The role of IL-1 in the pathogenesis of Still's disease has been demonstrated by ex vivo and gene expression studies.
Vloga IL-1 v patogenezi Stillove bolezni je bila dokazana s študijami ex vivo in študijami genske ekspresije.
Child
Otrok
In RA patients, no unexpected accumulation of anakinra was observed after daily subcutaneous doses for up to 24 weeks.
Pri bolnikih z RA niso opazili nikakršnega nepričakovanega kopičenja anakinre po dnevnih subkutanih odmerkih do 24 tednov.
Significant improvements are seen in the pain, tender joint count, physical function (HAQ score), acute phase reactants and in the patient's and physician's global assessment.
Pomembno izboljšanje vidimo pri bolečini, številu občutljivih sklepov, telesnem funkcioniranju (lestvica HAQ), reaktantih akutne faze in globalni oceni tako bolnika kot zdravnika.