FrancophonIA/ELRC3.0 huggingface dataset:
English: ORENCIA powder for concentrate for solution for infusion is available for paediatric patients 6 years of age and older.
Estonian: ORENCIA infusioonilahuse kontsentraadi pulber on saadaval lastele alates 6 aasta vanusest.
English: 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.
Estonian: Kokku on kontrolliga kliinilistes uuringutes subkutaanselt abatatsepti saanud 270 üle 65-aastast patsienti, sealhulgas ka 46 üle 75-aastast patsienti.
English: Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) in studies II, III, IV, V, and VI and the modified HAQ-DI in study I. The results from studies II, III, and VI are shown in Table 7.
Estonian: Uuringutes II, III, IV, V ja VI hinnati füüsilise toimetuleku paranemist tervise hindamise küsimustiku puude indeksiga (Health Assessment Questionnaire Disability Index, HAQ-DI) ja uuringus I modifitseeritud HAQ-DI.
English: Number of Vialsb
Estonian: Viaalide arvb
English: if you recently had a vaccination or are planning to have one, tell your doctor.
Estonian: kui teid on hiljuti vaktsineeritud või kaitsesüstimine on plaanis.
English: Inadequate response to MTX
Estonian: MTX raviefekt ebapiisav
English: DO NOT use the Pen if it is dropped after the cap is removed.
Estonian: ÄRGE kasutage süstlit, kui see pärast korgi eemaldamist maha kukub.
English: Adhesive plaster
Estonian: Plaaster klõps
English: Check the pre-filled syringe for damage.
Estonian: Kontrollige sildile trükitud kõlblikkusaega.
English: After reconstitution the solution should be clear and colourless to pale yellow.
Estonian: Lahus peab olema pärast lahustamist selge ja värvitu kuni kahvatukollane.
English: - After reconstitution the solution should be clear and colourless to pale yellow.
Estonian: - - Lahus peab olema pärast lahustamist selge ja värvitu kuni kahvatukollane.
English: ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.
Estonian: ORENCIA üksinda või kombinatsioonis metotreksaadiga (MTX) on näidustatud aktiivse psoriaatilise artriidi (PsA) raviks täiskasvanud patsientidele, kellel ravivastus eelneva HMARR-ravi, sealhulgas MTX-i, kasutamisel on olnud ebapiisav ning kes ei vaja psoriaatiliste nahakahjustuste tõttu täiendavat süsteemset ravi.
English: The liquid should be clear to pale yellow.
Estonian: Vedelik peab olema läbipaistev kuni kahvatukollane.
English: However, dizziness and reduced visual acuity have been reported as common and uncommon adverse reactions respectively from patients treated with ORENCIA, therefore if a patient experiences such symptoms, driving and use of machinery should be avoided.
Estonian: Kuna ORENCIA't saanud patsientidel on sagedaseks ja aeg-ajalt esinenud kõrvaltoimeks olnud vastavalt pearinglus ja nägemisteravuse langus, tuleks nende nähtude esinemisel autojuhtimisest ja masinate käsitsemisest hoiduda.
English: During period A, 74% were taking methotrexate (mean dose at study entry, 13.2 mg/m2/week) thus, 26% of patients received abatacept monotherapy in Period A. Of the 190 patients entering the study, 57 (30%) had previously been treated with TNF-inhibitor therapy.
Estonian: Periood A jooksul sai 74% patsientidest metotreksaati (keskmine annus uuringu alustamisel 13,2 mg/m2/nädalas), 26% patsientidest sai perioodil A abatatsepti monoteraapiana.
English: DON'T recap the needle.
Estonian: ÄRGE pange nõelale katet tagasi.
English: Don't touch the plunger while you remove the needle cover.
Estonian: Ärge puudutage nõelakatte eemaldamisel süstla kolbi.
English: Doses up to 50 mg/kg have been administered without apparent toxic effect.
Estonian: Ilmselget toksilisust ei ole täheldatud kuni annuse 50 mg/kg manustamiseni.
English: EU/1/07/389/011 4 pre-filled pens
Estonian: EU/1/07/389/011 4 pen-süstlit
English: Keep refrigerated until ready to use.
Estonian: Hoidke süstlit kuni kasutamiseni külmkapis.
English: ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate and for whom additional systemic therapy for psoriatic skin lesions is not required.
Estonian: ORENCIA üksinda või kombinatsioonis metotreksaadiga (MTX) on näidustatud aktiivse psoriaatilise artriidi (PsA) raviks täiskasvanud patsientidel, kellel ravivastus eelneva HMARR-ravi, sealhulgas MTX-i kasutamisel on olnud ebapiisav ning kes ei vaja psoriaatiliste nahakahjustuste tõttu täiendavat süsteemset ravi.
English: Patients switching from ORENCIA intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
Estonian: Üleminekul ORENCIA intravenoosselt ravilt subkutaansele manustamisele tuleb patsiendile manustada esimene subkutaanne annus järgmise plaanilise intravenoosse annuse asemel.
English: 125 mg, solution for injection subcutaneous use
Estonian: 125 mg, süstelahus subkutaanne
English: ORENCIA 50 mg solution for injection in pre-filled syringe The active substance is abatacept.
Estonian: ORENCIA 50 mg süstelahus süstlis Toimeaine on abatatsept.
English: Some vaccines should not be given while you are receiving ORENCIA.
Estonian: Kui kasutate ORENCIA't ei tohi mõnda vaktsiini manustada.
English: Therefore, ORENCIA solution for injection in pre-filled pen is not recommended for use in this patient population.
Estonian: Seetõttu ei soovitata pen-süstlis ORENCIA süstelahust sellistel patsientidel kasutada.
English: ORENCIA 125 mg solution for injection in pre-filled syringe The active substance is abatacept.
Estonian: ORENCIA 125 mg süstelahus süstlis Toimeaine on abatatsept.
English: GENERAL CLASSIFICATION FOR SUPPLY
Estonian: SÜSTIMISEKS VALMISTUMINE
English: EU/1/07/389/012 12 pre-filled pens (3 packs of 4)
Estonian: EU/1/07/389/012 12 pen-süstlit (3 nelja pen-süstliga pakendit)
English: - Remove the flip-top from the vial and wipe the top with an alcohol swab.
Estonian: - - Tõmmake ära kate viaali korgi pealt ja puhastage kork alkoholis immutatud tupsuga.
English: A significantly higher proportion of patients achieved an ACR 20 response after treatment with abatacept 10 mg/kg intravenous in PsA-I or 125 mg subcutaneous in PsA-II compared to placebo at Week 24 in the overall study populations.
Estonian: Uuringute kogupopulatsioonides saavutas 24. nädalaks ACR 20 ravivastuse platseeboga võrreldes oluliselt suurem protsent uuringus PsA-I 10 mg/kg intravenoosset abatatsepti või uuringus PsA-II 125 mg subkutaanset abatatsepti saanud patsiente.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 1, 3 AND 4 PRE-FILLED SYRINGES WITH NEEDLE GUARD
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND 1, 3 JA 4 NÕELAKAITSEGA SÜSTLIT SISALDAVATELE PAKENDITELE 1.
English: Don't inject if the liquid is cloudy or discoloured, or has visible particles.
Estonian: Ärge süstige, kui vedelik on hägune või värvi muutnud või selles on nähtavaid osakesi.
English: Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any foam that may be present.
Estonian: Kui pulber on täielikult lahustunud, tuleb nõelaga siseneda viaali hajutades võimaliku tekkinud vahu.
English: Remove the flip-top from the vial and wipe the top with an alcohol swab.
Estonian: Tõmmake ära kate viaali korgi pealt ja puhastage kork alkoholis immutatud tupsuga.
English: In study I, ACR responses were assessed at 7 years in 43 patients with 72% ACR 20 responses, 58% ACR 50 responses, and 44% ACR 70 responses.
Estonian: Uuringus I hinnati ACR alusel ravivastust seitsmendal aastal 43 patsiendil ACR 20 alusel 72%, ACR 50 alusel 58% ja ACR 70 alusel 44%.
English: Your baby may be at risk of severe infection caused by “live vaccines” for 14 weeks since your last ORENCIA administration.
Estonian: Teie lapsel võib 14 nädalat pärast viimast teile manustatud ORENCIA annust olla suur risk infektsioonide tekkeks elusvaktsiinide manustamisel.
English: 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
Estonian: Polüartikulaarse JIA-ga patsientide protsent (%), kes olid lühiajalise perioodi (4 kuud) lõpuks saavutanud ACRP ravivastuse või inaktiivse haiguse
English: Uncommon Chronic obstructive pulmonary disease exacerbated, bronchospasm, wheezing, dyspnea, throat tightness
Estonian: Kroonilise obstruktiivse kopsuhaiguse ägenemine, bronhospasm, hingeldus, düspnoe, pigistustunne kurgus
English: 0.7 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (light blue plunger).
Estonian: 0,7 ml süstel (I tüüpi klaasist) automaatse nõelakaitse ja ääriku laiendiga (helesinine kolb).
English: What ORENCIA is and what it is used for 2.
Estonian: 1. Mis ravim on ORENCIA ja milleks seda kasutatakse 2. Mida on vaja teada enne ORENCIA kasutamist 3.
English: EU/1/07/389/004 1 pre-filled syringe EU/1/07/389/005 4 pre-filled syringes
Estonian: EU/1/07/389/004 1 süstel EU/1/07/389/005 4 süstlit
English: If you miss your dose within three days of when you are supposed to take it, take your dose as soon as you remember and then follow your original dosing schedule on your chosen day.
Estonian: Kui unustate oma annuse, millal ORENCIA't oleks tulnud manustada, kuni kolmeks päevaks, manustage see koheselt ning edasi jätkake manustamist varasema ajakava järgi.
English: Twenty-two of 48 evaluable patients showed significant neutralizing activity.
Estonian: Olulist neutraliseerivat aktiivsust esines 22 patsiendil 48-st. Neutraliseerivate antikehade tekkimise võimalik kliiniline tähendus ei ole teada.
English: Antibodies directed against the whole abatacept molecule or to the CTLA-4 portion of abatacept were assessed by an ECL assay in patients with pJIA following repeated treatment with subcutaneous abatacept.
Estonian: Immunogeensus subkutaanse abatatseptiga ravitud pJIA patsientidel pJIA patsientidel hinnati pärast abatatsepti korduvat subkutaanset manustamist ECL meetodil abatatsepti terve molekuli või selle CTLA-4 osa vastaste antikehade olemasolu.
English: EU/1/07/389/006 12 pre-filled syringes (3 packs of 4)
Estonian: EU/1/07/389/009 12 süstlit nõelakaitsega (3 pakendit millest igas 4)
English: 4 pre-filled syringes
Estonian: 4 nõelakaitsega süstlit
English: Abatacepta +MTX
Estonian: abatatsepta +MTX
English:  Supplies checklist: alcohol swabs, cotton ball or gauze, adhesive plaster, Sharps container.
Estonian:  Lisavahendite kontroll-loend: alkoholiga immutatud vatitupsud, vatipadjake või marli, kleepplaaster, teravate meditsiinivahendite nõu.
English: Contact your doctor, nurse, or pharmacist for further instructions.
Estonian: Edasised juhised saate oma arsti, meditsiiniõe või apteekri käest.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 87.5 mg injection abatacept
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ORENCIA 87,5 mg süstelahus abatatsept s.c.
English: The ACR 20 responses with abatacept 125 mg subcutaneous vs placebo in patients who did not use non-biological 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]).
Estonian: ACR 20 ravivastuse määrad 125 mg subkutaanse abatatsepti vs. platseebo puhul mittebioloogilist HMARR-ravi mittesaanud patsientidel olid vastavalt 27,3% vs. 12,1% (15,15 [1,83; 28,47], erinevuse hinnang [95% CI]) ning mittebioloogilist HMARR-ravi saanud patsientidel vastavalt 44,9% vs. 26,9% (18,00 [7,20; 28,81], erinevuse hinnang [95% CI]).
English: The active substance is abatacept.
Estonian: Toimeaine on abatatsept.
English: Do not inject into an area where the skin is tender, bruised, red, scaly, or hard.
Estonian: Ärge süstige kohta, kus nahk on õrn, marraskil, punetav, ketendav või kõva.
English: Rheumatoid arthritis Adults
Estonian: Reumatoidartriit Täiskasvanud
English: Abatacept is not recommended for use in combination with TNF-inhibitors.
Estonian: Abatatsepti kombineerimine TNF inhibiitoritega ei ole soovitatav.
English: Do not use the pre-filled syringe if it is dropped after the needle cover is removed.
Estonian: Ärge kasutage süstlit, mis on pärast nõelakatte eemaldamist maha kukkunud.
English: Structural joint damage was assessed radiographically over a two-year period in studies II, VI, and SC-II.
Estonian: Uuringutes II, VI ja SC-II hinnati radiograafiliselt liigese struktuuri kahjustusi enam kui kahe aasta vältel.
English: Sucrose
Estonian: Gastriit
English: DO NOT replace the cap on the used Pen.
Estonian: ÄRGE pange kasutatud süstlile korki peale.
English: Abdominal pain, diarrhoea, nausea, dyspepsia, mouth ulceration, aphthous stomatitis, vomiting Uncommon Gastritis
Estonian: Kõhuvalu, kõhulahtisus, iiveldus, düspepsia, suuhaavand, aftoosne stomatiit, oksendamine
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 250 mg powder for concentrate for solution for infusion 2.
Estonian: ORENCIA 250 mg infusioonilahuse kontsentraadi pulber 2.
English: the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
Estonian: mõõduka kuni raske aktiivse reumatoidartriidi (RA) raviks täiskasvanutele, kellel varasem ravivastus ühe või mitme haigust modifitseeriva antireumaatilise ravimiga (HMARR),
English: A total of 404 patients 65 years of age and older, including 67 patients 75 years and older, received abatacept in placebo-controlled clinical trials.
Estonian: Kokku on platseebokontrolliga kliinilistes uuringutes abatatsepti saanud 404 üle 65-aastast patsienti, sealhulgas ka 67 üle 75-aastast patsienti.
English: In study VI, ACR responses were assessed at 2 years in 232 patients with 85% ACR 20 responses, 74% ACR 50 responses, and 54% ACR 70 responses.
Estonian: Uuringus VI hinnati ACR alusel ravivastust teisel aastal 232 patsiendil ACR 20 alusel 85%, ACR 50 alusel 74% ja ACR 70 alusel 54%.
English: At the start, your doctor or nurse may inject ORENCIA.
Estonian: Ravi alustamisel süstib ORENCIA't kas arst või meditsiiniõde.
English: In study II, ACR responses were assessed at 5 years in 270 patients with 84% ACR 20 responses, 61% ACR 50 responses, and 40% ACR 70 responses.
Estonian: Uuringus II hinnati ACR alusel ravivastust viiendal aastal 270 patsiendil ACR 20 alusel 84%, ACR 50 alusel 61% ja ACR 70 alusel 40%.
English: Paediatric pJIA population
Estonian: pJIA-ga lapsed
English: Needle guard click
Estonian: Pen-süstel ClickJect
English: 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]).
Estonian: Uuringus PsA-I oli PASI 50 ravivastuse saavutanud patsientide protsent abatatsepti puhul 28,6% ja platseebo puhul 14,3% (14,3 [-15,3; 43,9], erinevuse hinnang [95% CI]) ning PASI 75 ravivastuse saavutanud patsientide protsent abatatsepti puhul 14,3% ja platseebo puhul 4,8% (9,5 [-13,0; 32,0], erinevuse hinnang [95% CI]).
English: ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 6 years of age and older who have had an inadequate response to previous DMARD therapy.
Estonian: ORENCIA kombinatsioonis metotreksaadiga on näidustatud mõõduka kuni raske aktiivse polüartikulaarse juveniilse idiopaatilise artriidi (pJIA) raviks lastele alates 6 aasta vanusest, kes ei ole saavutanud piisavat ravivastust eelneva HMARR-raviga.
English: 125 mg/mL Pre-filled Syringe
Estonian: 125 mg/ml Süstel
English: - Remove the syringe and needle after 10 mL of water for injections have been injected into the vial.
Estonian: - - Eemaldage nõel koos süstlaga, kui viaali on süstitud 10 ml süstevett.
English: 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.
Estonian: Kokku on platseebokontrolliga kliinilistes uuringutes intravenoosselt abatatsepti saanud 404 üle 65aastast patsienti, sealhulgas ka 67 üle 75-aastast patsienti.
English: Discard the solution if any particulate matter or discolouration is observed.
Estonian: Hävitage lahus kui selles esineb tahkeid osakesi või märkate muutunud värvust.
English: ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy.
Estonian: ORENCIA kombinatsioonis metotreksaadiga on näidustatud mõõduka kuni raske aktiivse polüartikulaarse juveniilse idiopaatilise artriidi (pJIA) raviks lastele alates 2 aasta vanusest, kes ei ole saavutanud piisavat ravivastust eelneva HMARR-raviga.
English: Care of injection site:
Estonian: Süstekoha hooldus:
English: STEP 3: Inject ORENCIA
Estonian: 5. juhis: ORENCIA annuse süstimine
English: The most frequently reported organ cancer in the placebo-controlled clinical trials was lung cancer 0.17 (0.05, 0.43) per 100 patient-years for abatacept-treated patients, 0 for placebo-treated patients and 0.12 (0.08, 0.17) per 100 patient-years in the cumulative period.
Estonian: Platseebokontrolliga kliinilistes uuringutes kõige sagedamini teatatud organi vähiks oli kopsuvähk, mille esinemissageduse määr 100 patsiendiaasta kohta oli 0,17 juhtu (0,05; 0,43) abatatseptiga ravitud patsientidel, 0 juhtu platseebot saanud patsientidel ja 0,12 juhtu (0,08; 0,17) 100 patsiendiaasta kohta kumulatiivse perioodi jooksul.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ORENCIA 250 mg infusioonilahuse kontsentraadi pulber abatatsept
English: The most frequently reported organ cancer in the placebo-controlled clinical trials was lung cancer 0.17 (0.05, 0.43) per 100 patient-years for abatacept-treated patients, 0 for placebo-treated patients, and 0.12 (0.08, 0.17) per 100 patient-years in the cumulative period.
Estonian: Platseebokontrolliga kliinilistes uuringutes kõige sagedamini teatatud organi vähiks oli kopsuvähk, mille esinemissageduse määr 100 patsiendiaasta kohta oli 0,17 juhtu (0,05; 0,43) abatatseptiga ravitud patsientidel, 0 juhtu platseebot saanud patsientidel ning 0,12 juhtu (0,08; 0,17) 100 patsiendiaasta kohta kumulatiivse perioodi jooksul.
English: See the Package Leaflet for additional disposal information.
Estonian: Lisateavet hävitamise kohta leiate pakendi infolehest.
English: The frequencies of serious infection and malignancy relative to placebo among intravenous abatacept-treated patients over age 65 were higher than among those under age 65.
Estonian: Abatatsepti intravenoosselt saanud üle 65-aastastel patsientidel esines platseeboga võrreldes sagedamini infektsioone ja maligniteeti kui alla 65-aastastel.
English: Abatacept may cross the placenta into the serum of infants born to women treated with abatacept during pregnancy.
Estonian: Raseduse ajal abatatseptravi saanud naistel võib abatatsept läbida platsentat ning jõuda loote vereseerumisse.
English: ORENCIA powder for concentrate for solution for infusion is available for paediatric patients 6 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA powder for concentrate for solution for infusion).
Estonian: ORENCIA infusioonilahuse kontsentraadi pulber on saadaval lastele alates 6 aasta vanusest pJIA raviks (vt ORENCIA infusioonilahuse kontsentraadi pulbri ravimi omaduste kokkuvõte).
English: 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).
Estonian: pakend milles on 1, 3 või 4 süstlit nõelakaitsega ja mitmikpakend, milles on 12 süstlit nõelakaitsega (3 pakendit millest igas on 4).
English: In a mouse carcinogenicity study, increases in the incidence of malignant lymphomas and mammary gland tumours (in females) occurred.
Estonian: Hiirtel täheldati kartsinogeensuse uuringus pahaloomulise lümfoomi ja rinnanäärme (emastel) tuumorite sageduse suurenemist.
English: 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.
Estonian: Kooskõlas intravenoosse manustamise andmetega näitasid populatsiooni farmakokineetilised analüüsid subkutaanse abatatsepti kasutamisel pJIA patsientidel kliirensi suurenemise trendi kehakaalu suurenedes.
English: Doses up to 50 mg/kg have been administered intravenously without apparent toxic effect.
Estonian: Ilmselget toksilisust ei ole täheldatud kuni intravenoosse annuse 50 mg/kg manustamiseni.
English: Each pre-filled pen contains 125 mg of abatacept in one mL.
Estonian: Iga pen-süstel sisaldab 125 mg abatatsepti ühes milliliitris.
English: Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in patients with pJIA following repeated treatment with intravenous ORENCIA.
Estonian: Immunogeensus pJIA patsientidel hinnati pärast ORENCIA korduvat intravenoosset manustamist ELISA meetodil abatatsepti terve molekuli või selle CTLA-4 osa vastaste antikehade olemasolu.
English: Uncommon Arthralgia, pain in extremity
Estonian: Artralgia, valu jäsemetes
English: Major Clinical Responsec
Estonian: Oluline kliiniline ravivastusc
English: ORENCIA powder for concentrate for solution for infusion for intravenous administration is available for paediatric patients 6 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA powder for concentrate for solution for infusion).
Estonian: ORENCIA infusioonilahuse kontsentraadi pulber intravenoosseks manustamiseks on saadaval lastele alates 6 aasta vanusest pJIA raviks (vt ORENCIA infusioonilahuse kontsentraadi pulbri ravimi omaduste kokkuvõte).
English: 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.
Estonian: Kooskõlas intravenoosse manustamise andmetega osutas populatsiooni farmakokineetika analüüs subkutaanse abatatsepti kasutamisel RA patsientidel kliirensi suurenemise trendile kehakaalu suurenedes.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL SÜSTLA ETIKETT
English: Flange extender
Estonian: Ääriku laiend
English: Package leaflet: Information for the patient ORENCIA 125 mg solution for injection in pre-filled pen abatacept
Estonian: Pakendi infoleht: teave patsiendile ORENCIA 125 mg süstelahus pen-süstlis abatatsept
English: ORENCIA 125 mg solution for injection in pre-filled syringe with needle guard Abatacept
Estonian: ORENCIA 125 mg süstelahus nõelakaitsega süstlis Abatatsept