natgillin/translations-raw huggingface dataset:
In addition the MAH is requested to assess cases for which there is loss of efficacy to determine whether this is due to changes over time in PK/PD or antibody development.
Poleg tega mora imetnik dovoljenja za promet z zdravilom oceniti primere, pri katerih je prišlo do izgube učinkovitosti, da se ugotovi, ali je to posledica sprememb PK/PD, ki se pojavijo sčasoma, ali razvoja protiteles.
The patient or care giver should be advised to speak to the treating physician before adjusting the dose.
Bolniku ali negovalcu je treba svetovati, naj se pred prilagajanjem odmerka pogovori z lečečim zdravnikom.
Reproductive toxicity studies have been conducted in animals and have shown no effects on fertility or foetal morphology; however a study in pregnant monkeys showed reduced levels of oestrogen (see section 5.3).
Pri živalih so opravili študije reproduktivne toksičnosti, ki niso pokazale učinkov na plodnost ali fetalno morfologijo, vendar je študija pri brejih opicah pokazala znižane ravni estrogena (glejte poglavje 5.3).
Four additional adolescents (12-17 years) all with a diagnosis of FCAS subsequently enrolled in the open label extension where efficacy assessments were not collected.
Štirje dodatni mladostniki (12-17 let), od katerih so imeli vsi diagnozo FCAS, se je vključilo v odprto podaljšanje pozneje, ko ocen učinkovitosti niso zbirali.
Interleukin-1 (IL-1) blockade may interfere with immune response to infections.
Blokada interlevkina-1 (IL-1) lahko ovira imunski odziv na okužbe.
This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin).
To je klinično pomembno za substrate CYP450 z ozkim terapevtskim oknom, kjer se odmerek prilagaja vsakemu bolniku posebej (npr. varfarin).
Active Rilonacept Baseline Period (Weeks 13 to 15)
Aktivno izhodiščno obdobje z rilonaceptom (tedni 13 do 15)
Rilonacept Regeneron has not been tested in pregnant women and should not be used during pregnancy unless clearly necessary.
Zdravila Rilonacept Regeneron niso preučevali pri nosečnicah, zato se ne sme uporabljati med nosečnostjo, razen če je to nujno.
The risk for the foetus/mother is unknown.
Tveganje za plod/mater ni znano.
• The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Rilonacept Regeneron;
• o tveganju resnih okužb, vključno z oportunističnimi bakterijskimi, virusnimi in glivičnimi okužbami, pri bolnikih, zdravljenih z zdravilom Rilonacept Regeneron;
The effect of race could not be assessed because only Caucasian patients participated in the clinical studies in CAPS, reflecting the epidemiology of the disease.
Vpliva rase niso mogli ocenjevati, ker so v kliničnih študijah CAPS sodelovali samo belci, kar zrcali epidemiologijo bolezni.
If blood comes into the syringe, the needle has entered a blood vessel.
Če se v brizgi pojavi kri, je igla vstopila v žilo.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu in posodobila navodilo za uporabo, če bo potrebno.
Choose the area for the injection.
Izberite predel za injekcijo.
If necessary, the product may be kept at room temperature, but should be used within 3 hours of mixing.
Če je potrebno, lahko zdravilo hranite pri sobni temperaturi, a ga morate porabiti v 3 urah po mešanju.
• SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
• SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
It is unknown whether the use of IL-1 inhibitors like rilonacept increases the risk of reactivation of TB or of opportunistic infections.
Ni znano, ali uporaba zaviralcev IL-1, kakršen je rilonacept, zveča tveganje reaktivacije TB ali oportunističnih okužb.
Tumour necrosis factor (TNF) inhibitors have been associated with an increased risk of reactivation of latent tuberculosis (TB).
Zaviralce faktorja tumorske nekroze (TNF) povezujejo z zvečanim tveganjem reaktivacije latentne tuberkuloze (TB).
However, clinical experience in patients above 65 years is limited, therefore caution is recommended.
Vendar so klinične izkušnje pri bolnikih, starejših od 65 let, omejene, zato priporočamo previdnost.
Other medicines and Rilonacept Regeneron Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Druga zdravila in zdravilo Rilonacept Regeneron Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katero koli zdravilo.
The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP.
PSUR Cikel PSUR za zdravilo mora slediti polletnemu ciklu, dokler CHMP ne odloči drugače.
Elderly (65 years old or older)
Starejši bolniki (stari 65 let ali več)
Using a daily diary questionnaire, patients rated the following five signs and symptoms of CAPS: joint pain, rash, feeling of fever/chills, eye redness/pain, and fatigue, each on a scale of 0 (none, no severity) to 10 (very severe).
Z uporabo vsakodnevnega vprašalnika v obliki dnevnika so bolniki ocenjevali naslednjih pet znakov in simptomov CAPS: bolečina v sklepih, izpuščaj, občutek vročine/mrzlice, rdečica oči/bolečina v očeh in utrujenost, in to vsakega na lestvici od 0 (nič, brez izraženosti) do 10 (zelo močno izražen).
• 3 alcohol wipes
• 3 alkoholne zložence
Let the vial sit for about 1 minute.
Nato naj viala približno 1 minuto miruje.
• Do not inject into skin that is tender, red, or hard.
• Ne injicirajte v kožo, ki je občutljiva, trda ali rdeča.
Reported ISRs were generally mild to moderate in severity.
ISR, o katerih so poročali, so bile po stopnji izraženosti na splošno blage do zmerne.
The solvent is a colourless liquid.
Vehikel je brezbarvna tekočina.
STEP 5: Preparing the injection
KORAK 5: Priprava injekcije
If a patient becomes neutropenic the ANC should be monitored closely and treatment discontinuation should be considered.
Če bolnik postane nevtropeničen, je treba skrbno spremljati ANC, v poštev pride prekinitev zdravljenja.
• Allergic reactions.
• Alergijske reakcije.
Blood and lymphatic system disorder
Bolezni krvi in limfatičnega sistema
Hold the vial containing the mixture of powder and sterile water (solvent) sideways (not upright) with your thumb and a finger at the top and bottom of the vial, and quickly shake the vial back and forth (side-to-side) for about 1 minute.
Držite vialo, ki vsebuje mešanico praška in sterilne vode (vehikla), postrani (ne pokonci) s palcem in kazalcem na vrhu in dnu viale in hitro stresajte vialo naprej in nazaj (z ene strani na drugo) približno 1 minuto.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Rilonacept Regeneron are provided with a physician information pack containing the following:
Imetnik dovoljenja za promet z zdravilom (MAH) mora zagotoviti, da bodo pred uvedbo zdravila na trg vsi zdravniki, ki nameravajo predpisovati/izdajati zdravilo Rilonacept Regeneron, prejeli paket izobraževalnega gradiva za zdravnike, ki bo vseboval naslednje:
In Part A and Part B, physician's and patient's global assessment of disease activity and patients' assessment of the degree of limitation of their daily activities due to their disease were significantly improved for patients treated with rilonacept compared with those on placebo.
V delu A in delu B se je zdravnikova in bolnikova globalna ocena aktivnosti bolezni in bolnikova ocena stopnje omejitve dnevnih aktivnosti zaradi bolezni signifikantno izboljšala pri bolnikih, zdravljenih z rilonaceptom, v primerjavi s tistimi na placebu.
Thus it is expected that for a molecule that binds to IL-1, such as rilonacept, the formation of CYP450 enzymes could be normalized.
Zato je pričakovati, da bo molekula, ki se veže na IL-1, na primer rilonacept, lahko normalizirala nastajanje encimov s CYP450.
Bioavailability of rilonacept after a subcutaneous injection is estimated to be approximately 50%.
Ocenjujejo, da je biološka uporabnost rilonacepta po subkutani injekciji približno 50 %.
It is not meant to go into any muscle, vein, or artery.
Ni mišljeno, da bi šla v kako mišico, veno ali arterijo.
The observed incidence of antibody positivity in an assay may be influenced by several factors including assay sensitivity and specificity, sample handling, concomitant medicinal products, and underlying disease.
Na opaženo incidenco pozitivnosti protiteles v testu lahko vpliva več dejavnikov, vključno z občutljivostjo in specifičnostjo testa, ravnanjem z vzorci, sočasnim jemanjem drugih zdravil in osnovno boleznijo.
A study of embryo-foetal development was conducted with rilonacept in monkeys at doses up to approximately 4 times the human dose.
Pri opicah so opravili študijo embriofetalnega razvoja z rilonaceptom z odmerki, ki so bili do približno štirikrat večji od odmerka za človeka.
During the open-label extension, reductions in mean symptom scores, serum CRP, and serum SAA levels were maintained for up to one year.
Med odprtim podaljšanjem so se zmanjšanje povprečnih izidov simptomov, znižanje plazemskega CRP in ravni plazemskega SAA vzdrževali do enega leta.
Do not touch the needle with your hands or allow it to come into contact with any surfaces.
Ne dotaknite se igle z rokami in ne dovolite, da bi se igla dotaknila katerekoli površine.
By blocking the activity of IL-1 beta, Rilonacept Regeneron leads to an improvement in these symptoms.
Z blokiranjem aktivnosti IL-1 beta zdravilo Rilonacept Regeneron povzroči izboljšanje teh simptomov.
The safety and efficacy of rilonacept for the treatment of CAPS, including patients with FCAS, also known as familial cold urticaria syndrome (FCUS), and MWS was demonstrated in a randomised, double-blind, placebo-controlled study with two parts (A and B) conducted sequentially in the same patients.
Varnost in učinkovitost rilonacepta za zdravljenje CAPS, vključno z bolniki s FCAS, ki je znan tudi kot familiarni sindrom urtikarije zaradi mraza (FCUS), in MWS so dokazali v randomizirani, dvojno slepi, s placebom kontrolirani študiji v dveh delih (A in B), zaporedno opravljeni pri istih bolnikih.
Treatment should not be initiated in patients with an active or chronic infection (see section 4.3) and physicians should exercise caution when administering Rilonacept Regeneron to patients with a history of recurring infections or with underlying conditions that may predispose them to infections.
Zdravljenja ne smemo uvesti pri bolnikih z aktivno ali kronično okužbo (glejte poglavje 4.3), zdravniki pa morajo biti previdni, kadar dajejo zdravilo Rilonacept Regeneron bolnikom z anamnezo ponavljajočih se okužb ali z osnovnimi boleznimi, ki jih lahko naredijo dovzetne za okužbe.
• To protect yourself and others from possible needle sticks, it is very important to throw away every syringe, with the needle attached, in the puncture-resistant container right after use.
• Da sebe in druge zaščitite pred morebitnimi vbodi z iglo, je zelo pomembno, da po uporabi vsako iglo, pritrjeno na injekcijsko brizgo, zavržete v vsebnik, odporen na vbode.
Put the following items on a clean flat surface (see Figure 1):
Naslednje predmete položite na čisto in ravno površino (glejte sliko 1):
• Areas where you may inject Rilonacept Regeneron include the left and right sides of the abdomen, and left and right thighs.
• Predeli, kamor lahko injicirate zdravilo Rilonacept Regeneron, vključujejo levo in desno stran trebuha in levo in desno stegno.
Put the vial back on the table and let the vial sit for about 1 minute.
Položite vialo spet na mizo, kjer naj miruje približno 1 minuto.
Wye Valley Business Park Brecon Road, Hay-on-Wye Hereford HR3 5PG United Kingdom
Wye Valley Business Park Brecon Road, Hay-on-Wye Hereford HR3 5PG Velika Britanija
Improvement in key symptom scores was noted within one day of initiation of rilonacept therapy in most patients.
Izboljšanje rezultatov ključnih simptomov so pri večini bolnikov opazili v enem dnevu po uvedbi zdravljenja z rilonaceptom.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Rilonacept Regeneron should be made taking into account the benefit of breast-feeding to the child and the benefit of Rilonacept Regeneron therapy to the woman.
Pri odločanju o nadaljevanju/prekinitvi dojenja oziroma nadaljevanju/prekinitvi zdravljenja z zdravilom Rilonacept Regeneron moramo upoštevati koristi dojenja za otroka in korist zdravljenja z zdravilom Rilonacept Regeneron za žensko.
Lipid profile changes
Spremembe lipidnega profila
You or your caregiver will receive adequate training on how to mix the powder (dissolve to make a solution), prepare the dose, and administer the injection.
Vas ali vašega negovalca bodo ustrezno izurili v mešanju praška (treba ga je raztopiti, da nastane raztopina), pripravljanju odmerka in dajanju injekcije.
Clean the top of the Rilonacept Regeneron vial with a fresh, never-used alcohol wipe, wiping in one direction around the top.
Očistite vrh viale zdravila Rilonacept Regeneron z novim, neuporabljenim alkoholnim zložencem, tako da obrišete okrog vrha v eno smer.
After the addition of solvent, the vial contents should be reconstituted by shaking the vial for approximately one minute and then allowing it to sit for one minute.
Po dodatku vehikla morate rekonstituirati vsebino viale, tako da vialo približno eno minuto stresate in jo nato pustite eno minuto stati.
Before starting treatment with Rilonacept Regeneron, all patients should be evaluated for both active and inactive (latent) tuberculosis.
Pred začetkom zdravljenja z zdravilom Rilonacept Regeneron je treba vse bolnike pregledati glede aktivne in neaktivne (latentne) tuberkuloze.
Patients treated with rilonacept experienced more improvement in each of the five components of the composite endpoint than placebo-treated patients.
Bolnikom, ki so jih zdravili z rilonaceptom, se je stanje izraziteje izboljšalo v vsaki od petih komponent sestavljenega končnega stanja kot bolnikom, ki so prejemali placebo.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Start over with ‘STEP 1: Setting up for an injection' using new supplies.
Spet začnite s ‘KORAK 1: Priprava na injiciranje' in uporabite nove potrebščine.
Pre-treatment Baseline Period (Weeks -3 to 0)
Izhodiščno obdobje pred zdravljenjem (tedni -3 do 0)
In patients with CAPS, the most common and consistently reported adverse event associated with treatment was injection-site reaction (ISR).
Pri bolnikih s CAPS je bil najpogostejši neželeni dogodek, povezan z zdravljenjem, o katerem so dosledno poročali, reakcija na mestu injiciranja (ISR).
• OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES
• OBVEZNOST IZVEDBE UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET
Rilonacept Regeneron is not recommended for children younger than 12 years of age.
Zdravilo Rilonacept Regeneron ni priporočljivo za otroke, mlajše od 12 let.
If no blood appears, inject all the medicine in the syringe at a slow, steady rate, pushing the plunger all the way down.
Če se kri ne pojavi, počasi in enakomerno vbrizgajte vse zdravilo v brizgi in potisnite bat do konca navzdol.
CL /F (l/day)
CL /F (l/dan)
The sterile water should be at the 2.3-ml line (see Figure 6).
Sterilna voda mora segati do črte 2,3 ml (glejte sliko 6).
• Alcohol wipes
• alkoholni robčki;
Remove the needle cover and be careful not to touch the needle.
Odstranite pokrovček igle in pazite, da se ne boste dotaknili igle.
• After that, the recommended dose is 2.2 milligrams per kilogram, up to 160 mg, once weekly on the same day of the week.
• Temu sledi priporočeni odmerek 2,2 miligrama na kilogram, do 160 mg, enkrat na teden istega dne v tednu.
CONTENTS BY WEIGHT, BY VOLUMEN OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Twelve additional patients enrolled during the open label extension in which efficacy data were collected, 8 adults with a diagnosis of FCAS and 4 adolescents (13-16 years old), 3 with FCAS and 1 with FCAS/MWS overlap.
Med odprtim podaljšanjem, v katerem so zbirali podatke o učinkovitosti, se je vključilo 12 dodatnih bolnikov, 8 odraslih z diagnozo FCAS in 4 mladostniki (stari 13-16 let), 3 s FCAS in 1 s prekrivanjem FCAS in MWS.
An assessment of efficacy with respect to age group and diagnosis was obtained by comparing KSS at the end of the 24 week open label extension with KSS at baseline using time averaged daily mean scores.
Oceno učinkovitosti glede starostne skupine in diagnoze so dobili tako, da so primerjali izide ključnih simptomov (key symptom scores, KSS) na koncu 24-tedenskega odprtega podaljšanja s KSS v izhodišču in pri tem uporabili dnevne srednje izide, povprečene za čas.
The MAH is requested to perform a PK study in children.
Imetnik dovoljenja za promet z zdravilom mora opraviti PK študijo pri otrocih.
Should vaccination with live vaccines be indicated after initiation of Rilonacept Regeneron treatment, the recommendation is to wait for at least 6 weeks after the last Rilonacept Regeneron injection and before the next one (see section 4.4).
Če je po uvedbi zdravljenja z zdravilom Rilonacept Regeneron indicirano cepljenje z živimi cepivi, priporočamo, da počakate vsaj 6 tednov po zadnji injekciji zdravila Rilonacept Regeneron in 6 tednov pred naslednjo (glejte poglavje 4.4).
• The starting dose is 4.4 milligrams per kilogram of body weight, up to 320 milligrams (mg), given as one or two injections.
• Začetni odmerek je 4,4 miligrama na kilogram telesne mase, do 320 miligramov (mg), v obliki ene ali dveh injekcij.
Of the 19 patients, 7 tested positive at the last assessment (Week 18 or 24 of the open-label extension period), and 5 patients tested positive for neutralising antibodies on at least one occasion.
Sedem od teh 19 bolnikov je bilo pozitivnih ob zadnjem testiranju (18. ali 24. teden odprtega podaljšanega obdobja), pri 5 bolnikih pa je bil test za ugotavljanje nevtralizirajočih protiteles pozitiven vsaj enkrat.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
After preparing the Rilonacept Regeneron solution, it is best if used right away because it does not contain a preservative.
Po pripravi raztopine zdravila Rilonacept Regeneron je najbolje, če jo uporabite takoj, ker ne vsebuje konservansa.
For these reasons, comparison of the incidence of antibodies to rilonacept with the incidence of antibodies to other products may be misleading.
Zaradi teh razlogov lahko primerjava incidence protiteles proti rilonaceptu z incidenco protiteles proti drugim zdravilom zavaja.
Endpoint Period (Weeks 4 to 6)
Obdobje končnega stanja (tedni 4 do 6)
If you develop signs of an allergic (hypersensitivity) reaction during treatment with Rilonacept Regeneron (such as chest tightness, wheezing, trouble breathing, severe dizziness or lightheadedness, swelling of lips, or rash during or after the injection) then stop taking Rilonacept Regeneron and tell your doctor right away.
Če se med zdravljenjem z zdravilom Rilonacept Regeneron pri vas razvijejo znaki alergijske (preobčutljivostne) reakcije (kot so stiskanje v prsnem košu, sopenje, težave z dihanjem, huda omotica ali omedlevica, otekanje ustnic ali izpuščaj med injiciranjem ali po njem), takoj prekinite uporabo zdravila Rilonacept Regeneron in povejte zdravniku.
T1/2 terminal (day)
Končni razpolovni čas (T1/2) (dni)
Patients who experience vertigo during Rilonacept Regeneron treatment should wait for this to resolve completely before driving or operating machines.
Bolniki, ki imajo med zdravljenjem z zdravilom Rilonacept Regeneron vrtoglavico, morajo počakati, da ta povsem izzveni, preden začnejo voziti ali upravljati stroje.
The MAH shall complete, within the stated timeframe, the following measures:
Imetnik dovoljenja za promet z zdravilom mora v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
The risk for severe hypersensitivity reactions, which is not uncommon for injectable proteins, cannot be excluded (see section 4.3).
Nevarnosti resnih preobčutljivostnih reakcij, ki pri beljakovinah, ki se injicirajo, niso redke, ne moremo izključiti (glejte poglavje 4.3).
The fact that a limited number of paediatric patients were included in the clinical studies combined with the lack of data on the effect of long term IL-1ß suppression is a concern in view of the orphan nature of the condition.
Dejstvo, da je bilo vključenih v klinične študije omejeno število pediatričnih bolnikov, skupaj s pomanjkanjem podatkov o učinku dolgoročne supresije IL-1ß, je spričo dejstva, da ima zdravilo Rilonacept Regeneron za otroke naravo zdravila sirote, razlog za pozornost.
No pharmacokinetic data are available in patients with hepatic impairment.
Pri bolnikih z okvarami jeter ni na voljo nobenih farmakokinetičnih podatkov.
Hold the syringe and needle in your hand ready for injecting.
Držite brizgo in iglo, pripravljeno na injiciranje, v roki.
This medicine has been given ‘conditional approval'.
Zdravilo je pridobilo tako imenovano »pogojno dovoljenje za promet«.
• Check the expiration date (month and year) on the Rilonacept Regeneron carton and vial.
• Preverite rok uporabnosti (mesec in leto) na škatli in viali zdravila Rilonacept Regeneron.
Changes in your blood cholesterol levels or in your blood counts may also occur.
Lahko nastanejo tudi spremembe koncentracije holesterola v krvi ali vaše krvne slike.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Za navodila o rekonstituciji zdravila pred uporabo glejte poglavje 6.6.
Ask your pharmacist for these supplies.
Za te potrebščine se obrnite na farmacevta.
Based on limited data obtained from the clinical study, steady-state trough concentrations were similar between male and female patients.
Na podlagi omejenih podatkov, dobljenih iz klinične študije, so bile minimalne koncentracije v stanju ravnovesja pri bolnicah in bolnikih podobne.
Hypersensitivity to rilonacept or to any of the excipients.
Preobčutljivost za rilonacept ali katerokoli pomožno snov.
Patients were then given the option to enroll in a 24-week, open-label treatment extension phase during which all patients were treated with rilonacept 160 mg weekly.
Nato so bolniki imeli možnost, da se vključijo v 24-tedensko fazo podaljšanja odprtega zdravljenja, med katero so vsi bolniki prejemali rilonacept v odmerku 160 mg na teden.
Throw away the vial in the puncture-resistant container even if there is some medicine left in the vial.
Zavrzite vialo v vsebnik za ostre odpadke, tudi če je v viali še nekaj zdravila.
One patient in an open-label study of CAPS died after developing sinusitis and bacterial (Streptococcus pneumoniae) meningitis.
En bolnik v odprti študiji CAPS je umrl, potem ko sta se pri njem razvila sinuzitis in bakterijski meningitis (Streptococcus pneumoniae).
• Medicines called Tumour Necrosis Factor (TNF) inhibitors (such as etanercept, adalimumab, or infliximab) predominantly used in rheumatoid and autoimmune disease.
• zdravila, imenovana zaviralci faktorja tumorske nekroze (TNF) (kot so etanercept, adalimumab ali infliksimab), ki se večinoma uporabljajo za zdravljenje revmatoidne in avtoimunske bolezni;