natgillin/translations-raw huggingface dataset:
IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis.
IL-6 je vpleten v različna fiziološka dogajanja, npr. aktiviranje celic T, indukcijo sekrecije imunoglobulinov, indukcijo jetrne sinteze beljakovin akutne faze in stimulacijo hematopoeze.
• If your injection is given by another person, this person must also be careful when removing the pre-filled pen and disposing of it to prevent accidental needle stick injury and passing infection.
• Če injiciranje opravlja druga oseba, mora biti tudi ta oseba previdna pri odlaganju in odstranjevanju napolnjenega injekcijskega peresnika, da prepreči nenamerno poškodbo z iglo in prenos okužbe.
These results are consistent with those observed in patients treated with intravenous RoActemra.
Ti rezultati so skladni z opaženimi pri bolnikih, zdravljenih z intravenskim zdravilom
Continued therapy should be carefully reconsidered in a patient exhibiting no improvement within this timeframe.
O nadaljevanju zdravljenja pri bolnikih, pri katerih v tem časovnem obdobju ni izboljšanja, je treba skrbno premisliti.
In the SC Study 5.8% [3/52] developed positive neutralizing anti-tocilizumab antibodies without developing a serious or clinically significant hypersensitivity reaction.
V študiji s subkutano obliko so se pri 5,8 % [3/52] bolnikov pojavila pozitivna nevtralizirajoča protitelesa proti tocilizumabu brez razvoja resne ali klinično pomembne preobčutljivostne reakcije.
The double-blind controlled period was 6 months in four studies (studies I, III, IV and V) and was up to 2 years in one study (study II).
Obdobje dvojno slepe kontrole je v štirih študijah (študije I, III, IV in V) trajalo 6 mesecev, v eni študiji pa do 2 leti (študija II).
The European Medicines Agency has waived the obligation to submit the results of studies with RoActemra in all subsets of the paediatric population in treatment of cytokine release syndrome associated with chimeric antigen receptor (CAR) T cell therapy.
Evropska agencija za zdravila je opustila obvezo za oddajo rezultatov študij z zdravilom RoActemra v vseh podskupinah pediatrične populacije pri zdravljenju sindroma sproščanja citokinov, povezanega s terapijo s T-celicami s himernim antigenskim receptorjem (CAR).
Population pharmacokinetic analyses in any patient population tested so far indicate no relationship between apparent clearance and the presence of anti-drug antibodies.
Populacijske farmakokinetične analize doslej v nobeni od testiranih populacij bolnikov niso pokazale razmerja med navideznim očistkom in prisotnostjo protiteles proti zdravilu.
In the majority of patients, there was no increase in atherogenic indices, and elevations in total cholesterol responded to treatment with lipid lowering agents.
Pri večini bolnikov se aterogeni indeksi niso povečali in zvišanje celotnega holesterola se je odzvalo na zdravljenje s hipolipemiki.
Corticosteroid tapering was permitted from week six for patients who achieved a JIA ACR70 response.
Prilagoditev odmerka kortikosteroidov je bila dovoljena od 6. tedna za bolnike, ki so dosegli odziv JIA ACR 70.
Do not attempt to administer an injection until you are sure that you understand how to use the RoActemra syringe.
Ne poskušajte si dati injekcije, dokler niste prepričani, kako uporabljati napolnjeno injekcijsko brizgo RoActemra.
Doses above 1.2 g have not been evaluated in clinical studies (see section 5.1).
V kliničnih študijah niso ocenili odmerkov, večjih od 1,2 g (glejte poglavje 5.1).
If any of these applies to you, tell the doctor or nurse giving you the infusion.
Če se karkoli od naštetega nanaša na vas, obvestite zdravnika ali medicinsko sestro, ki vam bo dala infuzijo.
It is important to remain under your healthcare provider's care while using RoActemra.
Pomembno je, da ostanete pod zdravniškim nadzorom, medtem ko uporabljate zdravilo RoActemra.
• skin infection (cellulitis) sometimes with fever and chills
• okužba kože (celulitis), včasih z zvišano telesno temperaturo in mrzlico,
Patients transitioning from intravenous to subcutaneous formulation should administer their first subcutaneous dose instead of the next scheduled intravenous dose under the supervision of a qualified healthcare professional.
Bolniki, ki preidejo z intravenske na subkutano obliko, morajo prejeti prvi subkutani odmerek namesto naslednjega načrtovanega intravenskega odmerka pod nadzorom usposobljenega zdravstvenega delavca.
• Low absolute neutrophil count (ANC)
• Majhno absolutno število nevtrofilcev (absolute neutrophil count, ANC)
RoActemra should not be used during pregnancy unless clearly necessary.
Zdravila RoActemra ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors; ATC code: L04AC07.
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov; oznaka ATC: L04AC07.
In the open label extension phase (Part II), the overall rate of infections remained similar at 306.6 per 100 patient years.
V odprti, podaljšani fazi (del II) je celokupen delež okužb ostal podoben in sicer 306,6 na 100
If a child has a history of macrophage activation syndrome (activation and uncontrolled proliferation of specific blood cells), tell your doctor.
Če je otrok v preteklosti imel sindrom aktivacije makrofagov (aktivacijo in nekontrolirano razmnoževanje določene vrste krvnih celic), morate to povedati zdravniku.
Doses exceeding 800 mg per infusion are not recommended in CRS patients.
Odmerki, ki presegajo 800 mg na infuzijo, pri bolnikih s CRS niso priporočljivi.
• The outer area of the upper arms may also be used only if the injection is being given by a caregiver.
• Zunanji del nadlahti se za injiciranje lahko uporablja le, če vam injekcijo daje negovalec.
Thirty-nine patients (76.5%; 95% CI: 62.5%-87.2%) achieved a response.
Odziv je doseglo 39 bolnikov (76,5 %, 95-% IZ: 62,5 % - 87,2 %).
• Do not hold or push on the plunger while inserting the needle into the skin.
• Ne držite ali pritiskajte bata, ko vstavljate injekcijsko iglo v kožo.
• redness, heat, unusual swelling of skin or joint
• rdečina, toplota, nenavadno otekanje kože ali sklepa,
Cholesterol increased sJIA
zvišan holesterol sJIA
No clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation were reported.
Klinično pomembnih preobčutljivostnih reakcij, povezanih s tocilizumabom, ki bi zahtevale prekinitev zdravljenja, ni bilo.
RoActemra is used to treat:
Zdravilo RoActemra se uporablja za zdravljenje:
Results of the population PK analysis for sJIA and pJIA patients confirmed that body size is the only covariate which has an appreciable impact on the pharmacokinetics of RoActemra including elimination and absorption so that body-weight based dosing should be taken into consideration (see Tables 8 and 9).
Rezultati populacijske farmakokinetične analize za bolnike s sJIA in pJIA so potrdili, da je velikost telesa edina spremenljivka, ki ima znaten vpliv na farmakokinetiko zdravila RoActemra, vključno z izločanjem in absorpcijo, tako da je treba upoštevati odmerjanje na osnovi telesne mase (glejte preglednici 8 in 9).
The non-clinical safety profile of RoActemra in the cynomolgus monkey does not suggest a difference between intravenous and subcutaneous routes of administration.
Neklinične varnostne značilnosti zdravila RoActemrav opicah Cynomolgus ne kažejo na razlike med intravensko in subkutano potjo uporabe.
If either of these applies to you, tell a doctor.
Če se kar koli od naštetega nanaša na vas, obvestite zdravnika.
IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia.
IL-6 je domnevno vpleten v patogenezo nekaterih bolezni, med drugim vnetnih bolezni, osteoporoze in neoplazem.
Following subcutaneous dosing in RA patients, the time to peak serum RoActemra concentrations tmax was 2.8 days.
Po subkutanem odmerjanju pri bolnikih z revmatoidnim artritisom je bil čas do največje serumske koncentracije zdravila RoActemra tmax 2,8 dni.
• Do not press the green activation button yet.
• Zelenega gumba za aktivacijo v tem trenutku še ne pritisnite.
Patients should be advised to immediately seek medical help if they experience signs and symptoms of hepatic injury.
Bolnikom je treba svetovati, naj nemudoma poiščejo zdravniško pomoč, če se pojavijo znaki in simptomi okvare jeter.
Eighty five percent (64/75) of tocilizumab treated patients and 24.3% (9/37) of placebo treated patients achieved this endpoint.
85 % (64/75) bolnikov, zdravljenih s tocilizumabom in 24,3 % (9/37) bolnikov, zdravljenih s placebom, je doseglo ta cilj.
• fluid retention (oedema) in the lower legs, weight increase
• zadrževanje tekočine (edemi) v spodnjem delu nog, povečanje telesne mase,
• calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure
• zaviralce kalcijevih kanalčkov (npr. amlodipin), ki se uporabljajo za zdravljenje zvišanega krvnega tlaka,
Preparing for a RoACTEMRA Injection Find a comfortable space with a clean, flat, working surface.
Priprava na injiciranje zdravila RoACTEMRA Poiščite udoben prostor s čisto, ravno delovno površino.
• Check the Window area to see that it is filled with the purple indicator (See Figure L).
• Preverite okence in se prepričajte, da je napolnjeno z vijoličnim indikatorjem (glejte sliko L).
The MAH must agree the content and format of the educational material, together with a communication plan (including means of distribution), with the national competent authority prior to distribution of the educational material.
Imetnik dovoljenja za promet se mora pred razdeljevanjem izobraževalnega gradiva s pristojnim nacionalnim organom dogovoriti glede njegove vsebine in oblike, skupaj z načrtom obveščanja
• Check the expiration date on the pre-filled pen box.
• Preverite datum izteka roka uporabnosti na škatli napolnjenega injekcijskega peresnika
However, doses below 1025 mg of this medicine contain less than 23 mg sodium, so they are virtually sodium free.
Vendar pa odmerki tega zdravila, ki so manjši od 1025 mg, vsebujejo manj kot 23 mg natrija in so torej praktično "brez natrija".
• Guidance on how to diagnose Macrophage Activation Syndrome in sJIA patients
• smernice za diagnozo sindroma aktivacije makrofagov pri bolnikih s sJIA,
• Choose a different injection site for each new injection at least 1 inch (2.5cm) from the last area you injected.
• Za vsako novo injiciranje izberite drugo mesto injiciranja, ki naj bo od zadnjega območja injiciranja oddaljeno najmanj 1 palec (2,5 cm).
• Keep pressing down on the plunger while you take the needle out of the skin at the same angle as inserted.
• Bat še naprej potiskajte, medtem ko odstranite iglo iz kože pod enakim kotom, kot ste jo vstavili
NOTE: Once the needle-cap is removed, the syringe must be used immediately.
OPOMBA: Potem ko pokrovček injekcijske igle odstranite, je treba napolnjeno injekcijsko brizgo uporabiti nemudoma.
• You should use a different place each time you give yourself an injection, at least three centimeters from the area you used for your previous injection.
• Vsakič, ko si daste injekcijo, uporabite drugo mesto, vsaj tri centimetre oddaljeno od prejšnjega mesta injiciranja.
• To be sure the needle can be inserted correctly under the skin, pinch a fold of loose skin at the clean injection site with your free hand.
• Da bi zagotovo pravilno vstavili iglo pod kožo, s prosto roko naredite kožno gubo na očiščenem mestu za injiciranje.
Infections with neutropenia have been reported.
Poročali so o okužbah z nevtropenijo.
Suitability of the patient or parent/guardian for subcutaneous home use should be assessed and patients or parent/guardian instructed to inform a healthcare professional before administering the next dose if they experience symptoms of an allergic reaction.
O primernosti bolnika ali njegovega starša/skrbnika za subkutano domačo uporabo je treba presoditi in bolnikom ali njihovim staršem/skrbnikom naročiti, da pred aplikacijo naslednjega odmerka obvestijo zdravstvenega delavca, če izkusijo simptome alergijske reakcije.
• any part of the syringe appears to be damaged
• je kateri koli del napolnjene injekcijske brizge videti poškodovan.
• ciclosporin, used to suppress your immune system during organ transplants
• ciklosporin, ki se uporablja za zaviranje imunskega sistema pri presaditvi organa,
• When the purple indicator has stopped moving, release the green button.
• Ko se vijolični indikator ustavi, spustite zeleni gumb.
Choose and Prepare an Injection Site Choose an Injection Site
Izberite in pripravite mesto injiciranja Izberite mesto injiciranja
Continued durable responses were seen for over 3 years in the open label extension studies I-V.
Neprekinjene trajne odzive prek 3 let so opazili v odprtih, podaljšanih fazah študij I-V.
Allergic reactions during or after injection:
Alergijske reakcije med injiciranjem ali po njem:
Twist and pull off the green cap with the other hand (See Figure E).
Z drugo roko zasučite in potegnite zelen pokrovček (glejte sliko E).
• the medicine is any color besides colorless to yellowish
• je zdravilo drugačne barve od brezbarvne do rumenkaste,
Dose adjustments due to laboratory abnormalities (sJIA and pJIA)
Prilagoditev odmerka zaradi nenormalnih laboratorijskih vrednosti (sJIA in pJIA)
In an independent cohort of 15 patients (range: 9-75 years old) with axicabtagene ciloleucel-induced CRS, 53% responded.
V neodvisni kohorti 15 bolnikov (razpon: 9 - 75 let) s CRS, ki ga je povzročil aksicabtagen ciloleucel, je odziv doseglo 53 % bolnikov.
• Stevens-Johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin)
• Stevens-Johnsonov sindrom (kožni izpuščaj, ki lahko vodi do hudih mehurjev in luščenja kože),
Side effects in children and adolescents with sJIA or pJIA
Neželeni učinki pri otrocih in mladostnikih s sJIA ali pJIA
• Risk of Hepatotoxicity
• tveganje za hepatotoksičnost:
Action
Ukrepanje
Allergic reactions during or after infusion:
Alergijske reakcije med infuzijo ali po njej:
Cases of opportunistic infections have been reported.
Opisani so bili primeri oportunističnih okužb.
TCZ + Placebo (SC) N = 163
TCZ + placebo (s.c.) n = 163
Do not inject RoACTEMRA if the liquid is cloudy, discolored, or has lumps or particles in it because it may not be safe to use.
Ne injicirajte zdravila RoACTEMRA, če je raztopina motna, drugačne barve ali so v njej prisotne grudice ali delci, ker morda ni varna za uporabo.
Impaired lung function may increase the risk for developing infections.
Motnje v delovanju pljuč lahko povečajo tveganje za razvoj okužb.
• Hold the RoACTEMRA pre-filled pen firmly with one hand.
• Napolnjeni injekcijski peresnik zdravila RoACTEMRA trdno držite z eno roko.
The safety profile of tocilizumab in the pediatric population is summarized in the sections on pJIA and sJIA below.
Varnostni profil tocilizumaba pri pediatrični populaciji je povzet v spodnjih poglavjih za pJIA in sJIA.
At steady-state following a dose of 8 mg/kg every 4 weeks, the effective t1/2 decreased with decreasing concentrations within a dosing interval from 18 days to 6 days.
V stanju dinamičnega ravnovesja po odmerku 8 mg/kg na 4 tedne se je efektivni t1/2 skrajševal z zniževanjem koncentracij v odmernem intervalu od 18 dni do 6 dni.
• Check that the pre-filled pen box is not damaged.
• Preverite, da škatla napolnjenega injekcijskega peresnika ni poškodovana.
L-Histidine monohydrochloride monohydrate L-Arginine
L-histidinijev monoklorid monohidrat L-arginin
Lift the pre-filled pen straight off of the injection site at a 90° angle to remove the needle from the skin.
Napolnjeni injekcijski peresnik dvignite z mesta injiciranja pod kotom 90 °, da odstranite iglo iz kože.
After 12 weeks or at the time of escape, due to disease worsening, patients were treated in the open label phase at weight appropriate dosing.
Po 12 tednih ali zaradi poslabšanja bolezni so bili bolniki zdravljeni v odprti fazi z odmerjanjem primernim telesni masi.
Continued durable responses were seen for over 3 years in the ongoing open label extension studies I-V.
Neprekinjene trajne odzive prek 3 let so opazili v odprtih, podaljšanih fazah študij I-V, ki še potekajo.
Patients should inform their doctor immediately if they experience signs and symptoms of liver toxicity including tiredness, abdominal pain and jaundice.
Bolniki morajo nemudoma obvestiti zdravnika, če se pri njih pojavijo znaki in simptomi jetrne toksičnosti, vključno z utrujenostjo, bolečino v trebuhu in zlatenico;
RoActemra is given by injection under the skin (subcutaneously).
Zdravilo RoActemra se daje v obliki injekcije pod kožo (subkutano).
• Preparation of injection/infusion
• priprava injekcije/infuzije,
The proportion of patients with serious adverse events was balanced between the treatment groups (tocilizumab 11.7% vs. adalimumab 9.9%).
Delež bolnikov z resnimi neželenimi učinki je bil med zdravljenima skupinama uravnotežen (tocilizumab 11,7 % v primerjavi z adalimumabom 9,9 %).
Check with your healthcare provider for instructions about the right way to throw away used syringes.
Pri svojem zdravstvenem delavcu preverite, kako pravilno zavreči uporabljene napolnjene injekcijske brizge.
RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6.
Zdravilo RoActemra vsebuje učinkovino tocilizumab, ki je beljakovina, narejena iz specifičnih imunskih celic (monoklonsko protitelo), ki blokira delovanje posebne beljakovine (citokina), imenovane interlevkin-6.
• Wipe the injection site with an alcohol pad in a circular motion and let it air dry to reduce the chance of getting an infection.
• Mesto injiciranja obrišite z alkoholno blazinico s krožnimi gibi in pustite, da se posuši, da zmanjšate možnost okužbe.
ACR responses in study SC-I (% patients) at Week 24
Odzivi ACR v študiji SC-I (% bolnikov) v 24. tednu
Events reported during the infusion were primarily episodes of hypertension; events reported within 24 hours of finishing an infusion were headache and skin reactions (rash, urticaria).
Učinki, opisani med infundiranjem, so bile predvsem epizode hipertenzije, učinki, opisani v 24 urah po koncu infundiranja, pa so bili glavobol in kožne reakcije (izpuščaj, urtikarija).
Driving and using machines This medicine can cause dizziness.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo lahko povzroči omotico.
Treatment with a murine analogue did not exert toxicity in juvenile mice.
Zdravljenje z murinskim analogom ni predstavljalo toksičnosti za juvenilne miši.
Switching from 8 mg/kg intravenous once every 4 weeks to 162 mg subcutaneous once every week, will alter exposure in the patient.
Prehod z 8 mg/kg intravenske oblike enkrat na 4 tedne na 162 mg subkutano enkrat na teden spremeni izpostavljenost pri bolniku.
Population pharmacokinetic analysis for pJIA patients showed body size related impact on linear clearance so that body-weight based dosing should be taken into consideration (see Table 9).
Populacijska farmakokinetična analiza je pri bolnikih s pJIA pokazala, da velikost telesa vpliva na linearni očistek, zato je treba upoštevati odmerjanje na osnovi telesne mase (glejte preglednico 9).
Keep track of your next dose.
Zabeležite si svoj naslednji odmerek.
3 This adverse reaction was identified through post marketing surveillance but not observed in controlled clinical trials.
3 Ta neželeni učinek so zabeležili v spremljanju po prihodu zdravila na trg, v kontroliranih kliničnih preskušanjih pa ga niso opazili.
• The Patient Information Packs (to be given to patients by healthcare professionals)
• izobraževalno gradivo za bolnike, ki ga bolniku izroči zdravstveni delavec,
No (N = 55)
ne (n = 55)
Prescribers are reminded of the risk of false negative tuberculin skin and interferon-gamma TB blood test results, especially in patients who are severely ill or immunocompromised.
Zdravniki, ki predpisujejo zdravilo RoActemra, naj se zavedajo, da obstaja tveganje za lažno negativni rezultat tuberkulinskega kožnega testa in krvnega gama-interferonskega tuberkulinskega testa, posebno pri bolnikih, ki so hudo bolni ali imunokompromitirani.
Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Kožna guba je pomembna, da zagotovite injiciranje pod kožo (v maščobno tkivo), a ne globlje (v mišico).
At one year in the open label extension phase the overall rate of serious infections remained stable at 11.3 per 100 patient years.
Po enem letu je v odprti, podaljšani fazi celoten delež resnih okužb ostal stabilen pri 11,3 na 100 bolnik-let.
Exploratory Endpoints Annualized relapse rate, Week 52§
Eksplorativni opazovani dogodki Na leto preračunani delež recidivov, 52. teden§
No case of an overdose in the paediatric population has been observed.
Pediatrična populacija Primerov prekomernega odmerjanja v pediatrični populaciji ni bilo.
The most serious ADRs were serious infections, complications of diverticulitis, and hypersensitivity reactions.
Najbolj resni neželeni učinki so bile resne okužbe, zapleti divertikulitisa in preobčutljivostne reakcije.
• Details on how to report serious adverse reactions
• navodilo, kako poročati resne neželene učinke.
The study consisted of a 52-week blinded period (Part 1),
Študija je obsegala 52-tedensko slepo obdobje (1. del), ki mu je sledilo
Study III evaluated 623 patients who had an inadequate clinical response to MTX.
Študija III je ocenila 623 bolnikov, ki se klinično niso dovolj odzvali na metotreksat.
At high serum concentrations, when total clearance of RoActemra is dominated by linear clearance, an effective t ½ of approximately 32 days was derived from the population parameter estimates.
Pri velikih koncentracijah v serumu, ko v celotnem očistku zdravila RoActemra prevladuje linearni očistek, so na podlagi populacijskih ocen parametra ugotovili efektivni t1/2 približno 32 dni.
Due to the dependence of total clearance on RoActemra serum concentrations, the half-life of RoActemra is also concentration-dependent and varies depending on the serum concentration level.
Zaradi odvisnosti celotnega očistka od koncentracije zdravila RoActemra v serumu je tudi razpolovni čas zdravila RoActemra odvisen od koncentracije in se spreminja s koncentracijo zdravila v serumu.
Part I consisted of a 16-week active tocilizumab treatment lead-in period (n=188) followed by Part II, a 24-week randomized double-blind placebo-controlled withdrawal period (n=163), followed by Part III, a 64-week open-label period.
V I. delu je bilo 16-tedensko aktivno uvajalno zdravljenje s tocilizumabom (n = 188), sledil je II., 24-tedenski randomizirani, dvojno slepi, s placebom kontrolirani del (n = 163) in III., 64-tedenski odprti del.
There are no adequate data from the use of RoActemra in pregnant women.
Ni zadostnih podatkov o uporabi zdravila RoActemra pri nosečnicah.
• Do not use the pre-filled pen through clothing.
• Napolnjenega injekcijskega peresnika ne uporabljajte skozi oblačila.
Keep the green button pressed in and continue holding the pre-filled pen pressed firmly against your skin (See Figure J).
Še naprej pritiskajte zeleni gumb za aktivacijo in držite napolnjeni injekcijski peresnik trdno pritisnjen na kožo (glejte sliko J).
The safety profile of RoActemra across these indications remains similar and undifferentiated.
Varnostne značilnosti zdravila RoActemra pri teh indikacijah so podobne in se ne razlikujejo.
- to address the risk that patients using RoActemra may develop serious hepatic injury.
- da opozori na tveganje, da lahko zdravilo RoActemra povzroči resno okvaro jeter.
The safety profile of subcutaneous RoActemra was also evaluated in 52 paediatric patients with pJIA.
Varnostni profil subkutanega zdravila RoActemra je bil ovrednoten tudi pri 52 pediatričnih bolnikih s pJIA.
• Dispose of the full container as instructed by your healthcare provider or pharmacist.
• Napolnjen zabojnik odstranite po navodilih zdravstvenega delavca ali farmacevta.
Clinical response
Klinični odziv