natgillin/translations-raw huggingface dataset:
In study III the efficacy and safety of abatacept were assessed in patients with an inadequate response to a TNF-inhibitor, with the TNF-inhibitor discontinued prior to randomisation; other DMARDs were permitted.
V študiji III so učinkovitost in varnost abatacepta vrednotili pri bolnikih z nezadostnim odzivom na zaviralec TNF.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACK (INCLUDING BLUE BOX) 1.
ŠKATLA ZA SKUPNO PAKIRANJE (VKLJUČUJE MODRO OKENCE) 1.
Consistent with the intravenous data, population pharmacokinetic analyses for subcutaneous abatacept in pJIA patients revealed that there was a trend toward higher clearance of abatacept with increasing body weight.
V skladu z intravenskimi podatki so analize populacijske farmakokinetike subkutane uporabe abatacepta pri bolnikih s pJIA pokazale, da obstaja trend k višjemu očistku abatacepta s povečanjem telesne mase.
Abatacept SC n = 116 Proportion of randomised patients with induction of remission after 12 months of treatment DAS28-Remissiona Odds Ratio (95% CI) vs. MTX P value
Delež randomiziranih bolnikov z indukcijo remisije po 12 mesecih zdravljenja DAS28-remisijaa
ORENCIA SC PATIENT ALERT CARD TEXT
ZDRAVILO ORENCIA ZA SUBKUTANO UPORABO BESEDILO OPOZORILNE KARTICE ZA BOLNIKA
EU/1/07/389/013 4 pre-filled syringes with needle guard
EU/1/07/389/013 4 napolnjene injekcijske brizge z varovalom za iglo
Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red, or hard.
Zdravila se nikoli ne sme injicirati v predele, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
A total of 404 patients 65 years of age and older, including 67 patients 75 years and older, received intravenous abatacept in placebo-controlled clinical trials.
V s placebom nadzorovanih kliničnih preskušanjih je abatacept intravensko prejemalo skupaj 404 bolnikov, starih 65 let in starejših, vključno s 67 bolniki, starimi 75 let in starejšimi.
EU/1/07/389/009 12 pre-filled syringes with needle guard (3 packs of 4)
EU/1/07/389/009 12 napolnjenih injekcijskih brizg z varovalom za iglo (3 pakiranja po 4)
NAME OF THE MEDICINAL PRODUCT ORENCIA 50 mg solution for injection in pre-filled syringe ORENCIA 87.5 mg solution for injection in pre-filled syringe ORENCIA 125 mg solution for injection in pre-filled syringe 2.
ORENCIA 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ORENCIA 87,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ORENCIA 125 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 2.
ORENCIA 87.5 mg solution for injection in pre-filled syringe The active substance is abatacept.
ORENCIA 87,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Učinkovina je abatacept.
ORENCIA can lower your body's ability to fight infection and the treatment can make you more likely to get infections or make any infection you have worse.
Med zdravljenjem se tako lahko poveča dovzetnost za okužbe ali poslabša že prisotna okužba.
In study PsA-I, the proportions of patients achieving PASI 50 response was 28.6% with abatacept vs. 14.3% with placebo (14.3 [-15.3, 43.9], estimate of difference [95% CI]), and the proportion of patients who achieved PASI 75 response was 14.3% with abatacept vs. 4.8% with placebo (9.5 [-13.0, 32.0], estimate of difference [95% CI]).
V študiji PsA-I je delež bolnikov z doseženim odzivom PASI 50 pri uporabi abatacepta znašal 28,6% v primerjavi s 14,3 % pri uporabi placeba (14,3 [-15,3; 43,9], ocenjena razlika [95% interval zaupanja]), delež bolnikov z doseženim odzivom PASI 75 pa je pri uporabi abatacepta znašal 14,3% v primerjavi s 4,8% pri uporabi placeba (9,5 [-13,0; 32,0], ocenjena razlika [95% interval zaupanja]).
No difference in clinical response between subcutaneous and intravenous abatacept was seen across the 3 weight groups.
Med 3 skupinami bolnikov, razvrščenih v skupine na osnovi telesne mase, niso opazili razlik v kliničnem odzivu med subkutano in intravensko uporabo abatacepta.
Reconstitution of vials: under aseptic conditions, reconstitute each vial with 10 mL of water for injections, using the silicone-free disposable syringe provided with each vial and an 18-21 gauge needle.
Rekonstitucija vial: v aseptičnih pogojih vsako vialo rekonstituirajte z 10 ml vode za injekcije.
STEP 4: Dispose of the syringe and keep a record
KORAK: Odstranjevanje injekcijske brizge in vodenje evidence
Each week you can use the same area of your body, but use a different injection site in that area.
Zdravilo lahko vsak teden injicirate na istem predelu, vendar pa na izbranem predelu zdravilo vedno injicirajte na drugo mesto.
Breast-feeding should be discontinued during treatment with ORENCIA and for up to 14 weeks after the last dose of abatacept treatment.
Med zdravljenjem z zdravilom ORENCIA in še do 14 tednov po prejemu zadnjega odmerka abatacepta je treba prekiniti z dojenjem.
The ACR 20 responses with abatacept 125 mg subcutaneous vs placebo in patients who did not use nonbiological DMARDs were 27.3% vs 12.1%, respectively, (15.15 [1.83, 28.47], estimate of difference [95% CI]), and in patients who had used non-biological DMARDs were 44.9% vs 26.9%, respectively, (18.00 [7.20, 28.81], estimate of difference [95% CI]).
Odziv ACR 20 je pri uporabi abatacepta v odmerku 125 mg subkutano v primerjavi s placebom pri bolnikih, ki niso uporabljali nebioloških DMARD, znašal 27,3% v primerjavi z 12,1%, (15,15 [1,83; 28,47], ocenjena razlika [95% interval zaupanja]), pri bolnikih, ki so uporabljali nebiološke DMARD, pa 44,9% v primerjavi s 26,9%, (18,00 [7,20; 28,81], ocenjena razlika [95% interval zaupanja]).
If this happens, contact immediately your doctor who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Če ste uporabili večji odmerek zdravila ORENCIA, kot bi smeli V tem primeru se nemudoma posvetujte s svojim zdravnikom, ki bo nadziral morebiten pojav katerega koli znaka ali simptoma neželenih učinkov in po potrebi uvedel zdravljenje teh simptomov.
o Signs or symptoms of the safety concern and when to seek attention from a healthcare professional o Contact details of the ORENCIA prescriber o A warning message for patients who have received ORENCIA while pregnant to inform healthcare personnel before any vaccination is given to the baby due to the potential risk of severe infection caused by immunization with live vaccines
o Opozorilo bolnicam, ki so prejele zdravilo ORENCIA med nosečnostjo, da morajo o tem pred vsakim cepljenjem svojega otroka obvestiti zdravstvenega delavca, saj v tem primeru pri otroku obstaja tveganje za pojav resne okužbe pri cepljenju z živimi cepivi.
DO NOT PULL back the plunger at any time.
Bata ne smete nikoli povleči nazaj.
Package leaflet: Information for the patient ORENCIA 50 mg solution for injection in pre-filled syringe ORENCIA 87.5 mg solution for injection in pre-filled syringe ORENCIA 125 mg solution for injection in pre-filled syringe abatacept
Navodilo za uporabo ORENCIA 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ORENCIA 87,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ORENCIA 125 mg raztopina za injiciranje v napolnjeni injekcijski brizgi abatacept
b Each vial provides 250 mg of abatacept for administration.
b Ena viala vsebuje 250 mg abatacepta za infundiranje.
Participants in Period C at day 1765 included 33 of the 58 Period B abatacept recipients, 30 of the 59 Period B placebo recipients, and 13 of the 36 Period A non-responders.
V obdobju C je bilo na 1765. dan vključenih 33 od 58 bolnikov, ki so v obdobju B prejemali abatacept, 30 od 59 bolnikov, ki so v obdobju B prejemali placebo, in 13 od 36 bolnikov brez odziva v obdobju A. Srednja vrednost trajanja zdravljenja z abataceptom v obdobju C je 1815 dni (razpon od 57 do 2.415 dni, skoraj 61 mesecev).
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen (ClickJect)
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjenem injekcijskem peresniku (ClickJect) 4 ClickJect napolnjeni injekcijski peresniki
ORENCIA powder for concentrate for solution for infusion and ORENCIA solution for injection in pre-filled syringe are approved in the paediatric patients with pJIA.
Za uporabo pri pediatričnih bolnikih s pJIA je odobrena uporaba zdravila ORENCIA prašek za koncentrat za raztopino za infundiranje in zdravila ORENCIA raztopina za injiciranje v napolnjeni injekcijski brizgi.
Multipack: 2 vials and 2 silicone-free syringes (2 packs of 1) Multipack: 3 vials and 3 silicone-free syringes (3 packs of 1) 5.
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje Skupno pakiranje: 2 viali in 2 injekcijski brizgi brez silikona (2 pakiranji po 1) Skupno pakiranje: 3 viale in 3 injekcijske brizge brez silikona (3 pakiranja po 1) 5.
The percent of abatacept-treated patients achieving ACR 20, 50, and 70 responses in study II (patients with inadequate response to methotrexate), study III (patients with inadequate response to TNFinhibitor), and study VI (methotrexate-naive patients) are shown in Table 3.
Odstotek odzivov ACR 20, 50 in 70 pri bolnikih, ki so prejemali abatacept v študiji II (bolniki z nezadostnim odzivom na metotreksat), študiji III (bolniki z nezadostnim odzivom na zaviralec TNF) in študiji VI (bolniki, ki se predhodno še niso zdravili z metotreksatom), je prikazan v preglednici 3.
Read these instructions before you use the ORENCIA pre-filled syringe.
Pred začetkom uporabe zdravila ORENCIA napolnjena injekcijska brizga natančno preberite navodila.
Packs of 1, 3 or 4 pre-filled syringes with needle guard and multipack containing 12 pre-filled syringes with needle guard (3 packs of 4).
Pakiranja s po 1, 3 ali 4 napolnjenimi injekcijskimi brizgami z varovalom za iglo in skupno pakiranje, ki vsebuje 12 napolnjenih injekcijskih brizg z varovalom za iglo (3 pakiranja po 4).
Note: It is normal to see a drop of fluid leaving the needle.
Opomba: Na konici igle lahko opazite kapljico tekočine, kar je normalno.
The rate of seropositivity while patients were receiving abatacept therapy was 0.5% (1/189) during Period A; 13.0% (7/54) during Period B; and 12.8% (19/148) during Period C. For patients in Period B who were randomised to placebo (therefore withdrawn from therapy for up to 6 months) the rate of seropositivity was 40.7% (22/54).
Med zdravljenjem z abataceptom v obdobju A študije je bil delež seropozitivnosti 0,5% (1/189), v obdobju B 13,0% (7/54) in v obdobju C 12,8% (19/148).
Hold it firmly.
Nežno premešajte.
ORENCIA should be given to you again, 2 and then 4 weeks after the first infusion.
Kako pogosto boste prejemali zdravilo ORENCIA Zdravilo ORENCIA morate ponovno prejeti čez 2 in 4 tedne po prvi infuziji.
Abdominal pain, diarrhoea, nausea, dyspepsia, mouth ulceration, aphthous stomatitis, vomiting Uncommon Gastritis
Bolezni prebavil pogosti bolečine v trebuhu, driska, slabost, dispepsija, razjede v ustni votlini, aftozni stomatitis, bruhanje občasni gastritis
The entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 mcm).
Pri tem je treba uporabiti infuzijski set in sterilen, apirogen filter, ki minimalno veže proteine (velikost por 0,2 do 1,2 μm).
Rheumatoid arthritis Adults
Revmatoidni artritis Odrasli
A total of 270 patients 65 years of age and older, including 46 patients 75 years and older, received subcutaneous abatacept in controlled clinical trials.
V nadzorovanih kliničnih preskušanjih je abatacept subkutano prejemalo 270 bolnikov, starih 65 let in starejših, od katerih je bilo 46 bolnikov starih 75 let ali starejših.
EU/1/07/389/011 4 pre-filled pens
EU/1/07/389/011 4 napolnjeni injekcijski peresniki
In SC-I, the ACR 20 response rates at day 169 for subcutaneous and intravenous abatacept were respectively 78.3% (472/603 SC) and 76.0% (456/600 IV) in patients < 65 years, versus 61.1% (55/90 SC) and 74.4% (58/78 IV) for patients ≥ 65 years.
V študiji SC-I je bil odziv ACR 20 na dan 169 pri bolnikih < 65 let, 78,3% (472/603 s.c.) pri bolnikih, ki so prejemali abatacept subkutano in 76,0% (456/600 i.v.)
What ORENCIA looks like and contents of the pack ORENCIA powder for concentrate for solution for infusion is a white to off-white powder that can appear solid or broken into pieces.
Izgled zdravila ORENCIA in vsebina pakiranja ORENCIA prašek za koncentrat za raztopino za infundiranje je bel do sivobel prašek.
ORENCIA 50 mg solution for injection in pre-filled syringe The active substance is abatacept.
ORENCIA 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Učinkovina je abatacept.
Immunogenicity in adults treated with subcutaneous abatacept
Imunogenost pri odraslih, ki so se z abataceptom zdravili subkutano
Uncommon (may affect up to 1 in 100 people): tooth infection, nail fungal infection, infection in the muscles, blood stream infection, collection of pus under the skin, kidney infection, ear infection low white blood cells count skin cancer, skin warts low blood platelet count allergic reactions depression, anxiety, sleep disturbance migraine numbness dry eye, reduced vision eye inflammation palpitation, rapid heart rate, low heart rate low blood pressure, hot flush, blood vessels inflammation, flushing difficulty in breathing, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD) throat tightness rhinitis increased tendency to bruise, dry skin, psoriasis, skin redness, excessive sweating, acne hair loss, itching, hives painful joints pain in the extremities absence of menstruation, excessive menses flu-like illness, increased weight
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): okužba zob, glivična okužba nohtov, okužba mišic, okužba krvi, podkožno gnojno vnetje, okužba ledvic, okužba ušesa, nizko število belih krvnih celic, kožni rak, bradavice na koži, nizko število krvnih ploščic, alergijske reakcije, depresija, tesnoba, motnje spanja, migrena, odrevenelost, suhe oči, oslabljen vid, vnetje oči, palpitacije, hiter srčni utrip, počasen srčni utrip, nizek krvni tlak, navali vročine, vnetje krvnih žil, vročinski oblivi, težko dihanje, piskanje v prsih, kratka sapa, akutno poslabšanje pljučne bolezni, imenovane kronična obstrukcijska pljučna bolezen (KOPB), stiskanje v žrelu, vnetje nosne sluznice, hitrejši pojav modric, suha koža, luskavica, rdečina kože, čezmerno znojenje, akna, izpadanje las, srbenje, koprivnica, bolečine v sklepih, bolečine v okončinah, odsotnost menstruacije, zelo močna menstruacija, gripi podobno obolenje, zvečanje telesne mase.
Uncommon (may affect up to 1 in 100 people): tooth infection, nail fungal infection, infection in the muscles, blood stream infection, collection of pus under the skin, kidney infection, ear infection low white blood cells count skin cancer, skin warts low blood platelet count allergic reactions depression, anxiety, sleep disturbance migraine numbness dry eye, reduced vision eye inflammation palpitation, rapid heart rate, low heart rate low blood pressure, hot flush, blood vessels inflammation, flushing difficulty in breathing, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD) throat tightness rhinitis increased tendency to bruise, dry skin, psoriasis, skin redness, excessive sweating, acne hair loss, itching, hives painful joints pain in the extremities absence of menstruation, excessive menses flu-like illness, increased weight, infusion-related reactions
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): okužba zob, glivična okužba nohtov, okužba mišic, okužba krvi, podkožno gnojno vnetje, okužba ledvic, okužba ušesa, nizko število belih krvnih celic, kožni rak, bradavice na koži, nizko število krvnih ploščic, alergijske reakcije, depresija, tesnoba, motnje spanja, migrena, odrevenelost, suhe oči, oslabljen vid, vnetje oči, palpitacije, hiter srčni utrip, počasen srčni utrip, nizek krvni tlak, navali vročine, vnetje krvnih žil, vročinski oblivi, težko dihanje, piskanje v prsih, kratka sapa, akutno poslabšanje pljučne bolezni, imenovane kronična obstrukcijska pljučna bolezen (KOPB), stiskanje v žrelu, vnetje nosne sluznice, hitrejši pojav modric, suha koža, luskavica, rdečina kože, čezmerno znojenje, akne, izpadanje las, srbenje, koprivnica, bolečine v sklepih, bolečine v okončinah, odsotnost menstruacije, zelo močna menstruacija, gripi podobno obolenje, zvečanje telesne mase, neželeni učinki, povezani z infundiranjem zdravila.
It should be clear to pale yellow.
Raztopina mora biti bistra do bledo rumena.
One hundred and two (67%) of the subjects had received at least 1,080 days (~ 36 months) of abatacept therapy in Period C. All patients had at least 4 months of prior, open-label abatacept treatment in Period A.
Stodva (67 %) udeleženca v študiji sta se v obdobju C z abataceptom zdravila vsaj 1.080 dni (~ 36 mesecev).
Concomitant MTX, NSAIDs, corticosteroids, and TNF-inhibitors did not influence abatacept apparent clearance.
Sočasna uporaba metotreksata, nesteroidnih protivnetnih zdravil, kortikosteroidov in zaviralcev TNF ni vplivala na navidezni očistek abatacepta.
A randomised, double-blind study was conducted to assess the safety and efficacy of intravenous abatacept or infliximab versus placebo in patients with an inadequate response to methotrexate (study V).
Pri bolnikih z nezadostnim odzivom na metotreksat je bila izvedena randomizirana, dvojno slepa študija, ki je vrednotila varnost in učinkovitost intravenske uporabe abatacepta ali infliksimaba v primerjavi s placebom (študija V).
Your baby may be at risk of severe infection caused by “live vaccines” for 14 weeks since your last ORENCIA administration.
Pri otroku lahko 14 tednov po zadnjem odmerku zdravila ORENCIA, ki ste ga prejeli med nosečnostjo, obstaja tveganje za pojav hude okužbe po cepljenju z “živimi cepivi”.
Consistent with the intravenous data, population pharmacokinetic analyses for subcutaneous abatacept in RA patients revealed that there was a trend toward higher clearance of abatacept with increasing body weight.
V skladu z intravenskimi podatki, analize populacijske farmakokinetike za subkutano uporabo abatacepta pri bolnikih z RA kažejo tendenco povečevanja očistka abatacepta s povečevanjem telesne mase.
Keep Pen and the disposal container out of the reach of children.
Zdravilo in posodo za odstranjevanje ostrih predmetov shranjujte nedosegljivo otrokom!
Dispose the used pre-filled syringe into sharps disposal container right away after use.
Uporabljeno napolnjeno injekcijsko brizgo takoj zavrzite v posodo za odstranjevanje ostrih predmetov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 1, 3 AND 4 PRE-FILLED SYRINGES WITH NEEDLE GUARD
ŠKATLA ZA PAKIRANJA Z 1, 3 IN 4 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI Z VAROVALOM ZA IGLO
In the open-label extension of studies I, II, III, and VI durable and sustained ACR 20, 50, and 70 responses have been observed through 7 years, 5 years, 5 years, and 2 years, respectively, of abatacept treatment.
Trajanje in ohranitev odzivov ACR 20, 50 in 70 so v odprtem podaljšku študije I spremljali 7 let zdravljenja z abataceptom, v odprtem podaljšku študije II 5 let zdravljenja z abataceptom, v odprtem podaljšku študije III 5 let zdravljenja z abataceptom in v odprtem podaljšku študije VI 2 leti zdravljenja z abataceptom.
What you need to know before you are given ORENCIA
Kaj morate vedeti, preden boste prejeli zdravilo ORENCIA
Air Bubble
Zračni mehurček
A randomised, double-blind study was conducted to assess the safety and efficacy of abatacept or infliximab versus placebo in patients with an inadequate response to methotrexate (study V).
Pri bolnikih z nezadostnim odzivom na metotreksat je bila izvedena randomizirana, dvojno slepa študija, ki je vrednotila varnost in učinkovitost abatacepta ali infliksimaba v primerjavi s placebom (študija V).
Don't inject if the liquid is cloudy or discoloured, or has visible particles.
NE injicirajte, če je tekočina motna, kakršne koli drugačne barve ali vsebuje vidne delce.
ORENCIA 125 mg solution for injection in pre-filled syringe with needle guard Abatacept
ORENCIA 125 mg raztopina za injiciranje v napolnjeni injekcijski brizgi z varovalom za iglo abatacept subkutana uporaba
Study SC-II investigated the relative efficacy and safety of abatacept and adalimumab, both given subcutaneously without an intravenous loading dose and with background MTX, in patients with moderate to severely active RA and an inadequate response to previous MTX therapy.
V študiji SC-II so pri bolnikih z zmernim do močno aktivnim revmatoidnim artritisom (RA) in z nezadostnim odzivom na predhodno zdravljenje z metotreksatom (MTX) raziskovali učinkovitost in varnost abatacepta v primerjavi z adalimumabom, ki so ju bolniki prejemali subkutano brez polnilnega intravenskega odmerka ob osnovnem zdravljenju z MTX.
Remove the syringe and needle after 10 mL of water for injections have been injected into the vial.
Po injiciranju 10 ml vode za injekcije v vialo, odstranite injekcijsko brizgo in iglo.
Don't touch the plunger while you remove the needle cover.
Med odstranjevanjem pokrovčka igle se bata ne smete dotikati.
Don't shake the syringe, as this may damage the ORENCIA medicine.
To lahko škoduje zdravilu ORENCIA.
NAME OF THE MEDICINAL PRODUCT ORENCIA 250 mg powder for concentrate for solution for infusion 2.
ORENCIA 250 mg prašek za koncentrat za raztopino za infundiranje 2.
Packs of 4 pre-filled syringes with needle guard.
Pakiranja s 4 napolnjenimi injekcijskimi brizgami z varovalom za iglo.
4 pre-filled syringes with needle guard
4 napolnjene injekcijske brizge z varovalom za iglo
1 pre-filled syringe
Zunanji predel nadlakti
ORENCIA 50 mg solution for injection in pre-filled syringe
ORENCIA 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
See the Package Leaflet for additional disposal information.
Dodatne informacije o odstranjevanju najdete v navodilu za uporabo.
ORENCIA 125 mg solution for injection in pre-filled syringe The active substance is abatacept.
ORENCIA 125 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Učinkovina je abatacept.
Hold the pre-filled syringe by the body with the needle cover pointing down as shown.
2. korak: Preverite napolnjeno injekcijsko brizgo Napolnjeno injekcijsko brizgo primite za telo s pokrovčkom igle usmerjenim navzdol, kot je prikazano.
Pack of 4 pre-filled pens and multipack containing 12 pre-filled pens (3 packs of 4).
Pakiranje s 4 napolnjenimi injekcijskimi peresniki in skupno pakiranje, ki vsebuje 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4).
The effects of ORENCIA in pregnancy are not known, so do not use ORENCIA if you are pregnant unless your doctor specifically recommends it.
Zdravila ORENCIA med nosečnostjo ne smete uporabljati, razen če vam je tako izrecno svetoval zdravnik.
Packs of 1 or 4 pre-filled syringes and multipack containing 12 pre-filled syringes (3 packs of 4).
Pakiranja s po 1 ali 4 napolnjenimi injekcijskimi brizgami in skupno pakiranje, ki vsebuje 12 napolnjenih injekcijskih brizg (3 pakiranja po 4).
DO NOT inject if the liquid is cloudy, discoloured or has visible particles.
Ne injicirajte, če je tekočina motna, kakršne koli drugačne barve ali vsebuje vidne delce.
- Remove the syringe and needle after 10 mL of water for injections have been injected into the vial.
- Po injiciranju 10 ml vode za injekcije v vialo, odstranite injekcijsko brizgo in iglo.
Don't put the needle cover back on the needle once removed.
Ko ste pokrovček igle odstranili, ga ne nameščajte več nazaj na iglo.
In study VI, improvement was observed at 12 months in abatacept plus methotrexate group as compared with the methotrexate plus placebo group in both PCS and MCS, and was maintained through 2 years.
V študiji VI so po 12 mesecih v skupini, ki je prejemala abatacept in metotreksat v primerjavi s skupino, ki je prejemala metotreksat in placebo, opazili izboljšanje tako pri povzetku telesnih kot povzetku duševnih komponent.