natgillin/translations-raw huggingface dataset:
1,000 mg a Approximating 10 mg/kg.
1.000 mg a Približno 10 mg/kg.
ORENCIA can cause serious side effects, which may need treatment.
Zdravilo ORENCIA lahko povzroči resne neželene učinke, ki jih bo morda treba zdraviti.
While transitioning from TNF-inhibitor therapy to ORENCIA therapy, patients should be monitored for signs of infection (see section 5.1, study VII).
Pri prehodu z zdravljenja z zaviralci TNF na zdravljenje z zdravilom ORENCIA je treba bolnike nadzirati glede znakov okužbe (glejte poglavje 5.1, študija VII).
Your doctor may also do tests to examine your blood values.
Zdravnik lahko opravi tudi preiskave krvi.
At 10 mg/kg, the mean terminal half-life was 13.1 days, ranging from 8 to 25 days.
Pri odmerku 10 mg/kg je bil srednji končni razpolovni čas 13,1 dni, gibal pa se je od 8 do 25 dni.
It is very important to use ORENCIA exactly as prescribed by your doctor.
Zelo pomembno je, da zdravilo ORENCIA uporabljate natančno po zdravnikovih navodilih.
This was mostly due to non-serious upper respiratory tract infections in the 2 to 5 year age cohort.
To je bila predvsem posledica neresnih okužb zgornjih dihal v kohorti bolnikov, starih od 2 do 5 let.
Bristol-Myers Squibb Co. 38 Jackson Road Devens, MA 01434 USA
Bristol-Myers Squibb Co. 38 Jackson Road Devens, MA 01434 ZDA
The Marketing Authorisation Holder (MAH) shall ensure that in each Member State where ORENCIA is marketed, all patients who are expected to use ORENCIA have access to the Patient Alert Card (provided within each medicine pack).
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da imajo v vsaki državi članici v kateri se trži zdravilo ORENCIA vsi bolniki, ki uporabljajo zdravilo ORENCIA, na voljo opozorilno kartico za bolnika (na voljo mora biti v vsakem pakiranju zdravila).
Patients treated with ORENCIA may receive concurrent vaccinations, except for live vaccines.
Bolniki, ki se zdravijo z zdravilom ORENCIA, lahko sočasno prejmejo cepiva, razen živih cepiv.
Abdomen, avoid 5 cm around navel
Trebuh, izognite se območju 5 cm okrog popka
Period A was a 4-month open-label lead-in designed to induce an ACR Pedi 30 response.
Obdobje A je bila 4-mesečna uvodna, odprta faza, zasnovana za indukcijo odziva ACR Pedi 30.
Always hold the syringe by its body.
Injekcijsko brizgo vedno primite za telo.
if you have any kind of infection, including long-term or localised infection, if you often get infections or if you have symptoms of infection (e.g. fever, malaise, dental problems), it is important to tell your doctor.
če imate kakršno koli okužbo, vključno z dolgotrajno ali lokalizirano okužbo, če imate pogosto okužbe ali če imate simptome okužbe (npr. zvišana telesna temperatura, splošno slabo počutje, težave z zobmi), je pomembno, da o tem obvestite svojega zdravnika.
Abatacept may cross the placenta into the serum of infants born to women treated with abatacept during pregnancy.
Abatacept lahko skozi placento preide v serum dojenčkov, rojenim ženskam, ki so se med nosečnostjo zdravile z abataceptom.
During the first 4-month open-label period, the overall safety profile in these 409 pJIA patients was similar to that observed in the RA population with the following exceptions in the pJIA patients:
Med prvimi 4 meseci odprtega obdobja študije je bil celokupen profil varnosti pri teh 409 bolnikih s pJIA podoben tistemu, opaženemu pri populaciji bolnikov z RA, z naslednjimi izjemami pri bolnikih s pJIA:
The potential clinical relevance of neutralizing antibody formation is not known.
Možen klinični pomen tvorbe nevtralizirajočih protiteles ni znan.
Remove the syringe from the refrigerator.
Injekcijsko brizgo vzemite iz hladilnika.
ORENCIA should NOT be used with siliconised syringes (see section 6.6).
Zdravila ORENCIA se NE sme uporabljati v injekcijskih brizgah s silikonom (glejte poglavje 6.6).
Reversible pharmacological effects consisted of minimal transient decreases in serum IgG and minimal to severe lymphoid depletion of germinal centres in the spleen and/or lymph nodes.
Reverzibilni farmakološki učinki so obsegali minimalno prehodno zmanjšanje koncentracije serumskih IgG in minimalno do hudo izgubo germinalnih limfatičnih centrov v vranici in/ali bezgavkah.
The absence of concomitant methotrexate did not appear to be associated with a higher rate of seropositivity.
Kaže, da odsotnost sočasnega zdravljenja z metotreksatom ni bila povezana z višjim deležem seropozitivnosti.
Mean estimates for systemic clearance (0.28 mL/h/kg), volume of distribution (0.11 L/kg), and terminal half-life (14.3 days) were comparable between subcutaneous and intravenous administration.
Srednje ocene za sistemski očistek (0,28 ml/h/kg), volumen porazdelitve (0,11 l/kg) in končni razpolovni čas (14,3 dni) so pri subkutani in intravenski uporabi primerljive.
After proper training, you can give the injection to yourself, or it can be given by another person, for example a family member or friend.
Po ustreznem urjenju si boste zdravilo lahko injicirali sami, ali pa vam ga bo injiciral kdo drug, na primer kdo od svojcev ali prijateljev.
It is not known whether ORENCIA passes into human milk.
Ni znano, če zdravilo ORENCIA prehaja v materino mleko.
For full-dose delivery, hold the Pre-filled Pen in place for 15 seconds AND wait until blue indicator stops moving in window.
Za celotno injiciranje odmerka napolnjen injekcijski peresnik zadržite na mestu 15 sekund IN počakajte, da se moder kazalec v okencu neha premikati.
Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28.
Abatacept selektivno modulira ključni kostimulacijski signal, potreben za polno aktivacijo T limfocitne ekspresije CD28.
Other medicines: ORENCIA should not be mixed with other medicines or infused concomitantly in the same intravenous line with other medicines.
Druga zdravila: Zdravila ORENCIA ne smete mešati z drugimi zdravili ali infundirati sočasno z drugimi zdravili preko iste intravenske linije.
Month 12 41%‡
12. mesec 41%‡
e After 6 months, patients were given the opportunity to enter into an open-label study.
e Po 6 mesecih so imeli bolniki možnost vključitve v odprto študijo.
Polyarticular juvenile idiopathic arthritis is a long-term inflammatory disease affecting one or more joints in children and adolescents.
Poliartikularni juvenilni idiopatski artritis je dolgotrajna vnetna bolezen, ki prizadene enega ali več sklepov pri otrocih in mladostnikih.
Get to know your Pre-filled Syringe There are 3 types of pre-filled syringes:
Seznanite se z napolnjeno injekcijsko brizgo Na voljo so 3 vrste napolnjenih injekcijskih brizg:
Allergic reactions may occur after the use of ORENCIA.
Pri uporabi zdravila ORENCIA se lahko pojavijo alergijske reakcije.
Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic Tlymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1).
Abatacept je fuzijski protein, sestavljen iz zunajcelične domene s humanim citotoksičnim limfocitom T povezanega antigena 4 (CTLA-4 - human cytotoxic T-lymphocyte-associated antigen 4), vezane na modificirani Fc del humanega imunoglobulina G1 (IgG1).
Based on its mechanism of action, abatacept is expected to have no or negligible influence on the ability to drive and use machines.
Glede na mehanizem delovanja se domneva, da abatacept nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Treatment with ORENCIA should not be initiated in patients with active infections until infections are controlled.
Pri bolnikih z aktivnimi okužbami se zdravljenje z zdravilom ORENCIA ne sme uvesti, dokler okužbe niso pod nadzorom.
In study II, 43% of the patients who had not achieved an ACR 20 response at 6 months developed an ACR 20 response at 12 months.
V študiji II je bil pri 43% bolnikov, ki niso dosegli odziva ACR 20 po 6 mesecih, odziv ACR 20 dosežen po 12 mesecih.
Blood glucose testing
Testiranje glukoze v krvi
Complete ALL steps for full-dose delivery:
Dokončajte VSE korake za popolno injiciranje odmerka:
The time to and proportion of patients with the relapse of the disease observed between the two groups were similar.
Obdobje do povrnitve bolezni in delež bolnikov s povrnitvijo bolezni sta bila podobna v obeh skupinah.
Patient's Name: ____________________
Ime in priimek bolnika:
Placebo group in Period B
skupina s placebom v obdobju B
The rate is consistent with previous experience, and there was no effect of immunogenicity on pharmacokinetics, safety, or efficacy.
Delež je v skladu s predhodnimi izkušnjami, vpliva imunogenosti na farmakokinetiko, varnost ali učinkovitost zdravila pa niso zaznali.
Studies in vitro and in animal models demonstrate that abatacept modulates T lymphocyte-dependent antibody responses and inflammation.
Študije in vitro in na živalskih modelih kažejo, da abatacept modulira od limfocitov T odvisni protitelesni odziv in vnetje.
If you received ORENCIA while you were pregnant, your baby may be at a higher risk for getting such an infection for up to approximately 14 weeks after the last dose you received during pregnancy.
Če ste zdravilo ORENCIA prejeli med nosečnostjo, lahko pri otroku obstaja večje tveganje za takšno okužbo do približno 14 tednov po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
Uncommon Depression, anxiety, sleep disorder (including insomnia)
Psihiatrične motnje občasni depresija, tesnoba, motnje spanja (vključno z nespečnostjo)
There is no need to remove the air bubble.
Zračnega mehurčka ni treba odstranjevati.
if you are using a blood glucose monitor to check your blood glucose levels.
če uporabljate merilce krvnega sladkorja za nadziranje vrednosti glukoze v krvi.
The overall safety profile with respect to adverse reactions was similar between the two groups over the 24-month period.
V 24-mesečnem obdobju je bil celokupen varnostni profil glede na neželene učinke podoben med obema skupinama.
Data were analysed in an as-observed analysis using mean change in total score from the previous annual visit.
Podatki so bili analizirani z opazovalno analizo na osnovi povprečne spremembe v skupni oceni od predhodnega letnega obiska.
If you forget to use ORENCIA
Če ste pozabili uporabiti zdravilo ORENCIA
Immunogenicity to abatacept following long-term subcutaneous administration was assessed by a new electrochemiluminescence (ECL) assay.
Imunogenost abatacepta po dolgotrajni subkutani uporabi so ovrednotili z novim elektrokemiluminiscenčnim (ECL) testom.
Step 6: After the Injection
6. korak: Po injiciranju
After reconstitution and dilution, the infusion solution is stable for 24 hours in a refrigerator, but for bacteriological reasons, it is to be used immediately.
Po rekonstituciji in redčenju je raztopina za infundiranje stabilna 24 ur, če se jo shranjuje v hladilniku, vendar pa jo je zaradi bakterioloških razlogov treba uporabiti takoj.
DAS28-CRP Remissione
DAS28-CRP remisijae
In study SC-II, structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde-modified Total Sharp Score (mTSS) and its components.
V študiji SC-II so strukturne poškodbe sklepa vrednotili radiološko in jih izrazili kot spremembo od izhodišča na osnovi skupne Sharpove ocene, modificirane po van der Heijdeu (mTSS; “van der Heijde-modified Total Sharp Score”), in njenih komponent.
Your doctor may recommend a different method for monitoring your blood glucose levels.
Zdravnik vam bo morda priporočil drugo metodo za nadziranje vrednosti krvnega sladkorja.
What ORENCIA is and what it is used for
Kaj je zdravilo ORENCIA in za kaj ga uporabljamo
Doses up to 50 mg/kg have been administered without apparent toxic effect.
Uporabljeni so bili odmerki do 50 mg/kg brez očitnih toksičnih učinkov.
The primary outcome was the mean change in disease activity in abatacept-treated patients compared to placebo-treated patients at 6 months with a subsequent double-blind assessment of safety and efficacy of abatacept and infliximab at 12 months.
Primarni cilj je bil srednja sprememba aktivnosti bolezni pri bolnikih, ki so prejemali abatacept v primerjavi z bolniki, ki so prejemali placebo po 6 mesecih s kasnejšim dvojno slepim vrednotenjem varnosti in učinkovitosti abatacepta in infliksimaba po 12 mesecih.
The solution is clear, colourless to pale yellow with a pH of 6.8 to 7.4.
Bistra, brezbarvna do bledo rumena raztopina z vrednostjo pH od 6,8 do 7,4. 4.
Certain vaccinations may cause infections from the vaccine.
Pri nekaterih cepljenjih lahko pride do okužbe, ki je posledica vnosa cepiva.
Study SC-II: abatacept versus adalimumab
Študija SC-II: abatacept v primerjavi z adalimumabom
ORENCIA should not be used during pregnancy unless the clinical condition of the woman requires treatment with abatacept.
Zdravila ORENCIA ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje z abataceptom.
walking, hygiene, reach, grip, and activities.
hranjenje, hoja, higiena, doseganje stvari, moč prijemanja in aktivnosti.
It may also be helpful to write down any questions or concerns about the injection so you can ask your doctor, nurse or pharmacist.
Morda bo koristno tudi, če si zabeležite kakršno koli vprašanje ali dvom o injiciranju zdravila, da se boste lahko posvetovali s svojim zdravnikom, z medicinsko sestro ali s farmacevtom.
Study III
Študija III
Keep refrigerated until ready to use.
Shranjujte v hladilniku, dokler niste pripravljeni na uporabo.
A study in the subcutaneous program was conducted to investigate the effect of withdrawal (three months) and restart of abatacept subcutaneous treatment on immunogenicity.
V okviru programa subkutane uporabe zdravila je bila izvedena študija, ki je raziskovala vpliv prekinitve (tri mesece) in ponovne uvedbe subkutanega zdravljenja z abataceptom na imunogenost.
Look at the liquid in the syringe (Figure 2).
Preverite tekočino v injekcijski brizgi (slika 2).
The increased incidence of lymphomas and mammary tumours observed in mice treated with abatacept may have been associated with decreased control of murine leukaemia virus and mouse mammary tumour virus, respectively, in the presence of long-term immunomodulation.
Večja pojavnost limfomov in tumorjev mlečne žleze pri miših, ki so prejemale abatacept, je lahko povezana z zmanjšanim nadzorom virusa mišje levkemije in virusa mišjega tumorja mlečne žleze (mouse mammary tumour virus) v prisotnosti dolgotrajne imunomodulacije.
Study VII: Safety of abatacept in patients with or without washout of previous TNF-inhibitor therapy
Študija VII: Varnost abatacepta pri bolnikih z ali brez faze izpiranja po predhodnem zdravljenju z zaviralcem TNF
HAQc Disability Index
Indeks nezmožnosti HAQc
Proportion (%) of polyarticular JIA patients with ACRP responses or inactive disease at end of short-term period (4 months) Ages 2 to 17 years n=219
Preglednica 9: Delež (%) bolnikov s poliartikularnim JIA z ACRP odzivom ali neaktivno boleznijo ob koncu kratkoročnega obdobja (4 meseci) Starost 2 do 17 let n=219
The primary endpoint for both PsA-I and PsA-II was the proportion of patients achieving ACR 20 response at Week 24 (day 169).
Primarni cilj obeh študij, študije PsA-I in študije PsA-II, je bil delež bolnikov z doseženim odzivom ACR 20 v 24. tednu (169. dan).
ACR30 65 ACR50 50 ACR70 28 ACR90 13 Inactive disease
ACRP30 ACRP50 ACRP70 ACRP90 ACRP100 neaktivna bolezen*
If neurological symptoms suggestive of PML occur during ORENCIA therapy, treatment with ORENCIA should be discontinued and appropriate diagnostic measures initiated.
Če se med zdravljenjem z zdravilom ORENCIA pojavijo nevrološki simptomi, ki kažejo na PML, je treba zdravljenje z zdravilom ORENCIA prekiniti in izvesti ustrezne diagnostične preiskave.
ORENCIA increases the risk of getting infections.
Zdravilo ORENCIA poveča tveganje za okužbe.
Exploratory studies to assess the effect of abatacept on the antibody response to vaccination in healthy subjects as well as the antibody response to influenza and pneumococcal vaccines in rheumatoid arthritis patients suggested that abatacept may blunt the effectiveness of the immune response, but did not significantly inhibit the ability to develop a clinically significant or positive immune response.
Raziskovalne študije za oceno učinka abatacepta tako na protitelesni odziv na cepljenje pri zdravih osebah kot tudi protitelesni odziv na cepljenje proti gripi in pnevmokokom pri bolnikih z revmatoidnim artritisom so pokazale, da abatacept lahko zmanjša učinkovitost imunskega odziva, vendar pa ni pomembneje zavrl sposobnosti za razvoj klinično pomembnega ali pozitivnega imunskega odziva.
Information on the relative safety in a clinical trial versus infliximab is summarised in section 5.1.
Podatki o relativni varnosti v kliničnih preskušanjih v primerjavi z infliksimabom so povzeti v poglavju 5.1.
Look closely to make sure that the amount of liquid in the pre-filled syringe is at or just above the fill line for your prescribed dose:
Skrbno poglejte in se prepričajte, da tekočina v napolnjeni injekcijski brizgi sega do ali le nekoliko nad oznako, ki označuje predpisani odmerek:
Proportion of patients with ACR responses at week 24 in studies PsA-I and PsA-II
Delež bolnikov z odzivi ACR v 24. tednu v študijah PsA-I in PsA-II Študija PsA-Ia
5 How to store ORENCIA 6.
5 Shranjevanje zdravila ORENCIA 6.
SC bioavailability (F) increased by 28% and the absorption rate constant (KA) was higher in pJIA patients than RA patients.
Biološka uporabnost (F) pri subkutani uporabi je večja za 28%, konstanta hitrosti absorpcije (KA) pa je pri bolnikih s pJIA višja kot pri bolnikih z RA.
Three patients had SAEs (postoperative wound infection, H1N1 influenza, and myocardial ischemia in 1 patient each) that were not considered related to the study drug.
Pri treh bolnikih so poročali o resnih neželenih učinkih (pooperativna okužba rane, influenca H1N1 in ishemija miokarda, vsak od teh učinkov pri 1 bolniku), ki pa niso bili povezani s študijskim zdravilom.
It is unknown whether abatacept is excreted in human milk.
Ni znano, ali se abatacept izloča v materino mleko.
STEP 2: Choose and prepare your injection site
KORAK: Izbira in priprava mesta za injiciranje
Inadequate response to TNF Inhibitor
Nezadosten odziv na zaviralec TNF
d Reduction in HAQ-DI of ≥ 0.3 units from baseline.
d Zmanjšanje indeksa HAQ-DI za ≥ 0,3 enote od izhodišča.
the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.
zdravljenje močno aktivne in progresivne bolezni pri odraslih bolnikih z revmatoidnim artritisom, ki se predhodno še niso zdravili z metotreksatom.
Inject: push the plunger with your thumb as far as it will go.
Injiciranje: s palcem potisnite bat do konca.
Start of ORENCIA Treatment:
Začetek zdravljenja z zdravilom ORENCIA:
Always keep your Sharps container out of reach of children and animals.
Posodo za odstranjevanje ostrih predmetov vedno shranjujte izven dosega otrok in živali.
Of the 54 patients withdrawn from ORENCIA during the doubleblind period for up to 6 months, none had an infusion reaction upon re-initiation of ORENCIA.
Pri nobenem od 54 bolnikov, pri katerih je bilo zdravljenje z zdravilom ORENCIA med dvojno slepim obdobjem prekinjeno za do 6 mesecev, se po ponovni uvedbi zdravljenja z zdravilom ORENCIA ni pojavila infuzijska reakcija.
The results from studies II, III, and VI are shown in Table 7.
Rezultati iz študij II, III in VI so prikazani v preglednici 7.
Excipient with known effect sodium: 0.375 mmol (8.625 mg) per vial
Pomožna snov z znanim učinkom natrij: 0,375 mmol (8,625 mg) na vialo
Your doctor will advise you on the duration of treatment and what other medicines you may continue to take while on ORENCIA.
Zdravnik vam bo povedal kako dolgo bo trajalo zdravljenje in katera druga zdravila lahko med zdravljenjem z zdravilom ORENCIA jemljete še naprej.
From a microbiological point of view, the reconstituted solution should be diluted immediately.
Z mikrobiološkega stališča je treba raztopino razredčiti takoj po rekonstituciji.
Pharmacokinetics of abatacept for subcutaneous injection have been studied in patients 2 to 17 years of age.
Farmakokinetiko abatacepta pri subkutanem injiciranju so preučevali pri bolnikih, starih od 2 do 17 let.
The efficacy and safety of abatacept were assessed in two randomised, double-blind, placebocontrolled trials (studies PsA-I and PsA-II) in adult patients, age 18 years and older.
Učinkovitost in varnost abatacepta so vrednotili v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih (študiji PsA-I in PsA-II) pri odraslih bolnikih, starih 18 let in starejših.
The geometric mean estimate (90% confidence interval) for the bioavailability of abatacept following subcutaneous administration relative to intravenous administration is 78.6% (64.7%, 95.6%).
Geometrijska srednja ocena (90% interval zaupanja) za biološko uporabnost abatacepta po subkutani uporabi v primerjavi z intravensko uporabo je 78,6% (64,7%; 95,6%).
Abatacept has been shown to be present in rat milk.
Pri podganah so dokazali prisotnost abatacepta v mleku.
Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.
Zdravnik vam bo povedal kako dolgo bo trajalo zdravljenje in katera druga zdravila, vključno z drugimi imunomodulirajočimi zdravili, če sploh katero, lahko med zdravljenjem z zdravilom ORENCIA jemljete še naprej.
If the dose is missed by more than three days, the patient should be instructed when to take the next dose based on medical judgment (condition of the patient, status of disease activity, etc).
Če je od predvidenega dneva injiciranja minilo več kot tri dni, mora o dajanju naslednjega odmerka zdravila presoditi zdravnik (na osnovi stanja bolnika, statusa aktivnosti bolezni ipd.).
Release Needle Guard: slowly lift your thumb from the plunger to activate the needle guard.
Sprostitev varovala za iglo: palec počasi dvignite z bata, da se aktivira varovalo za iglo.
In the 2 to 5 year age cohort, 39 (84.8%) patients completed 2 years.
V kohorti bolnikov, starih od 2 do 5 let, je 2-letno obdobje zaključilo 39 (84,8 %) bolnikov.
Health-related quality of life was assessed by the SF-36 questionnaire at 6 months in studies I, II, and III and at 12 months in studies I and II.
Z zdravstvenim stanjem povezana kvaliteta življenja je bila v študijah I, II in III ovrednotena s SF36 vprašalnikom (SF-36 questionnaire) po 6 mesecih, v študijah I in II pa tudi po 12 mesecih.
Administration of live vaccines to infants exposed to abatacept in utero is not recommended for 14 weeks following the mother's last exposure to abatacept during pregnancy.
Pri dojenčkih, ki so bili in utero izpostavljeni abataceptu, cepljenje z živimi cepivi ni priporočljivo 14 tednov po zadnji izpostavljenosti matere abataceptu med nosečnostjo.
ORENCIA solution for injection is injected under the skin (subcutaneous use).
Zdravilo ORENCIA raztopina za injiciranje se vbrizga pod kožo (subkutana uporaba).
Medicinal products which affect the immune system, including ORENCIA, may affect host defences against infections and malignancies, and affect vaccination responses.
Zdravila, ki vplivajo na imunski sistem, vključno z zdravilom ORENCIA, lahko oslabijo obrambni mehanizem proti okužbam in novotvorbam ter vplivajo na odziv na cepljenje.
You will find detailed instructions for the preparation and administration of ORENCIA at the end of this leaflet (see "Important instructions for use").
Podrobna navodila za pripravo in aplikacijo zdravila ORENCIA so na voljo na koncu tega navodila (glejte “Pomembna navodila za uporabo").
No dose recommendations can be made.
Priporočenih odmerkov ne moremo navesti.
Remove the needle from the skin and let go of the surrounding skin.
Iglo izvlecite iz kože in spustite okoliško stisnjeno kožo.
In the substudy 108 subjects were randomised 1:1 in double blinded fashion to receive abatacept at doses approximating 10 mg/kg (ABA 10) or 5 mg/kg (ABA 5).
Podštudija je vključevala 108 oseb, ki so bile randomizirane v razmerju 1:1, na dvojno slepi način, tako, da so prejemale abatacept v odmerku približno 10 mg/kg (ABA 10) ali 5 mg/kg (ABA 5).