FrancophonIA/ELRC3.0 huggingface dataset:
English: The pJIA SC study included 46 patients in the 2 to 5 year age cohort and 173 patients in the 6 to 17 year age cohort.
Slovenian: V študijo subkutane uporabe pri pJIA je bilo v kohorto bolnikov, starih od 2 do 5 let, vključenih 46 bolnikov, v kohorto bolnikov, starih od 6 do 17 let, pa 173 bolnikov.
English: Patients switching from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
Slovenian: Bolniki, ki bodo z intravenskega zdravljenja z abataceptom prešli na subkutano zdravljenje, morajo prvi subkutani odmerek prejeti namesto naslednjega predvidenega intravenskega odmerka.
English: The type of serious infections was similar between the abatacept and placebo treatment groups (see section 4.4).
Slovenian: V skupinah, ki so prejemale abatacept in placebo, so bile vrste resnih okužb podobne (glejte poglavje 4.4).
English: PREPARE FOR INJECTION
Slovenian: PRIPRAVA ZA INJICIRANJE
English: Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.
Slovenian: Med zdravljenjem z zdravilom ORENCIA se posvetujte z zdravnikom ali farmacevtom preden vzamete katero koli zdravilo.
English: The geometric mean (CV%) cmin at day 169 were 7.8 mcg/mL (56.3%) for the 3/3 mg/kg, 24.3 mcg/mL (40.8%) for 10/10 mg/kg, and 26.6 mcg/mL (39.0%) for the 30/10 mg/kg regimens.
Slovenian: Geometrijska sredina (CV%) Cmin je na 169. dan pri režimu 3/3 mg/kg znašala 7,8 μg/ml (56,3%), pri režimu 10/10 mg/kg 24,3 μg/ml (40,8%), pri režimu 30/10 mg/kg pa 26,6 μg/ml (39,0%).
English: Tell your doctor as soon as possible if you notice any of the following: feeling generally unwell, dental problems, burning sensation during urination, painful skin rash, painful skin blisters, coughing
Slovenian: Če opazite kar koli od naslednjega, o tem čim prej obvestite svojega zdravnika: splošno slabo počutje, težave z zobmi, pekoč občutek med uriniranjem, boleč kožni izpuščaj, boleče kožne mehurje, kašelj.
English: Co-administration of abatacept with biologic immunosuppressive or immunomodulatory agents could potentiate the effects of abatacept on the immune system.
Slovenian: Pri sočasni uporabi abatacepta in bioloških imunosupresivnih ali imunomodulirajočih zdravil se učinki abatacepta na imunski sistem lahko okrepijo.
English: Boolean Clinical Remission Estimate of Difference (95% CI) vs. MTX
Slovenian: Boolean klinična remisija Ocenjena razlika (95 % IZ) v primerjavi z MTX
English: Remove the pre-filled syringe from the injection site and let go of the pinched skin.
Slovenian: Napolnjeno injekcijsko brizgo odstranite z mesta injiciranja in sprostite kožno gubo.
English: In study VI, the efficacy and safety of abatacept were assessed in methotrexate-naive, Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide 2 (Anti-CCP2)-positive patients with early, erosive rheumatoid arthritis (≤ 2 years disease duration) who were randomised to receive abatacept plus methotrexate or methotrexate plus placebo.
Slovenian: V študiji VI so učinkovitost in varnost abatacepta vrednotili pri bolnikih, ki se predhodno še niso zdravili z metotreksatom, in so bili pozitivni za revmatoidni faktor (RF - Rheumatoid Factor) in/ali za anti-ciklični citrulinski peptid 2 (anti-CCP2 - anti-Cyclic Citrullinated Peptide 2) ter so imeli zgodnji, erozivni revmatoidni artritis (≤ 2 leti trajajoča bolezen).
English: There is insufficient evidence to assess the safety and efficacy of abatacept in combination with anakinra or rituximab (see section 4.4).
Slovenian: Varnosti in učinkovitosti abatacepta v kombinaciji z anakinro ali rituksimabom zaradi nezadostnih podatkov ni bilo možno ovrednotiti (glejte poglavje 4.4).
English: In placebo-controlled clinical trials, malignancies were reported in 1.2% (31/2,653) of abatacepttreated patients and in 0.9% (14/1,485) of placebo-treated patients.
Slovenian: V s placebom nadzorovanih kliničnih preskušanjih so o novotvorbah poročali pri 1,2% (31/2.653) bolnikov, ki so prejemali abatacept, in 0,9% (14/1.485) bolnikov, ki so prejemali placebo.
English: Age and gender (when corrected for body weight) did not affect clearance.
Slovenian: Starost in spol (korigirana na telesno maso) na očistek nista vplivala.
English: The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg given every week regardless of weight.
Slovenian: Priporočeni odmerek zdravila ORENCIA za odrasle z revmatoidnim artritisom ali s psoriaznim artritisom je 125 mg enkrat na teden, ne glede na telesno maso.
English: Preparation of infusion: immediately after reconstitution, dilute the concentrate to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Priprava za infundiranje: takoj po rekonstituciji koncentrat nadalje razredčite do 100 ml z 0,9% raztopino natrijevega klorida (9 mg/ml) za injiciranje.
English: Immediately after reconstitution, the concentrate must be further diluted to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Takoj po rekonstituciji morate koncentrat nadalje razredčiti do 100 ml z 0,9% raztopino natrijevega klorida (9 mg/ml) za injiciranje.
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.
Slovenian: Če ste pozabili uporabiti odmerek in od tega ni minilo več kot tri dni, odmerek uporabite takoj, ko se spomnite, nato pa nadaljujte z uporabo zdravila na prvotno izbrani dan v tednu.
English: In addition, study V investigated the safety and efficacy of abatacept or infliximab relative to placebo.
Slovenian: V študiji V so raziskovali tudi varnost in učinkovitost abatacepta ali infliksimaba v primerjavi s placebom.
English: Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation.
Slovenian: Bolnik med zdravljenjem z abataceptom ali v 3 mesecih po prekinitvi zdravljenja ne sme prejeti živih cepiv.
English: The rate of progression of structural damage in year 2 was significantly lower than that in year 1 for patients randomised to abatacept (p < 0.0001).
Slovenian: Pri bolnikih, ki so bili randomizirani na abatacept, je bil obseg napredovanja strukturnih poškodb v drugem letu pomembno manjši kot v prvem letu (p < 0,0001).
English: Do not use the pre-filled syringe if the needle is damaged or bent.
Slovenian: NE uporabljajte napolnjene injekcijske brizge, če je igla kakor koli poškodovana ali upognjena.
English: Similar inhibition was observed in both treatment groups up to 24 months (mTSS (mean ± standard deviation [SD] = 0.89 ± 4.13 vs 1.13 ±8.66), erosion score (0.41 ± 2.57 vs 0.41 ±5.04), and JSN score (0.48 ±2.18 vs 0.72 ±3.81)) for the abatacept (n=257) and adalimumab (n=260) groups, respectively.
Slovenian: V obeh skupinah so do 24 mesecev opazili podobno inhibicijo (mTSS (srednja vrednost ± standardna deviacija [SD]) = 0,89 ± 4,13 v primerjavi z 1,13 ± 8,66), ocena erozije (0,41 ± 2,57 v primerjavi z 0,41 ± 5,04) in ocena JSN (0,48 ± 2,18 v primerjavi z 0,72 ± 3,81)) za skupino z abataceptom (n=257) oziroma skupino z adalimumabom (n=260).
English: b Concurrent DMARDs included one or more of the following: methotrexate, chloroquine/hydroxychloroquine, sulfasalazine,
Slovenian: b Sočasna imunomodulirajoča protirevmatična zdravila (DMARDs - disease-modifying anti-rheumatic drugs) so vključevala enega ali več naslednjih: metotreksat, klorokin/hidroksiklorokin, sulfasalazin, leflunomid, azatioprin, zlato in anakinro.
English: In this case, you will get training on how to inject ORENCIA yourself.
Slovenian: V tem primeru vas bodo o pravilnem injiciranju zdravila natančno poučili.
English: In study SC-I, ACR responses were assessed at 5 years with 85% (356/421) ACR 20 responses, 66% (277/423) ACR 50 responses, and 45% (191/425) ACR 70 responses.
Slovenian: Odziv ACR 20 je bil ugotovljen pri 85% bolnikov (356/421), odziv ACR 50 pri 66% bolnikov (277/423), odziv ACR 70 pa pri 45% bolnikov (191/425).
English: EU/1/07/389/001 1 vial and 1 silicone-free syringe
Slovenian: EU/1/07/389/001 1 viala in 1 injekcijska brizga brez silikona
English: In study VI, which only included adults, a significantly higher proportion of patients in the abatacept plus methotrexate group (41%) achieved DAS28 (CRP)-defined remission (score < 2.6) versus the methotrexate plus placebo group (23%) at year 1.
Slovenian: V študiji VI, v katero so bili vključeni le odrasli bolniki, je bila v prvem letu remisija, opredeljena z DAS28 (CRP) (ocena < 2,6), dosežena pri pomembno večjem deležu bolnikov v skupini, ki je prejemala abatacept in metotreksat (41%), kot v skupini, ki je prejemala metotreksat in placebo (23%).
English: During the 12-month treatment period, adverse reactions were reported in 44.5% (53/119), 41.4% (48/116), and 44.0% (51/116) and serious adverse reactions were reported in 2.5% (3/119), 2.6% (3/116) and 0.9% (1/116) of patients treated in the three treatment groups, respectively.
Slovenian: Med 12-mesečnim obdobjem zdravljenja so o neželenih učinkih poročali pri 44,5 % (53/119), 41,4 % (48/116) oziroma 44,0 % (51/116) bolnikov, ki so se zdravili v teh treh skupinah, o resnih neželenih učinkih pa pri 2,5 % (3/119), 2,6 % (3/116) oziroma 0,9 % (1/116) zdravljenjih bolnikih.
English: Choose your injection site in either the abdomen or front of the thigh.
Slovenian: Izberite mesto injiciranja na trebuhu ali sprednjem delu stegna.
English: ACR 70 Month 3 Month 6 Month 12
Slovenian: ACR 70 3. mesec 6. mesec 12. mesec
English: Number of Vialsb
Slovenian: Število vialb
English: Tell your doctor immediately if you notice any of the following: severe rash, hives or other signs of allergic reaction swollen face, hands or feet trouble breathing or swallowing fever, persistent cough, weight loss, listlessness
Slovenian: Če opazite kar koli od naslednjega, o tem nemudoma obvestite svojega zdravnika: hud izpuščaj, koprivnico ali druge znake alergijske reakcije, otekanje obraza, rok ali nog, težko dihanje ali požiranje, zvišana telesna temperatura, trdovraten kašelj, hujšanje, ravnodušnost.
English: There is no relevant use of ORENCIA in children under two years old.
Slovenian: Pri otrocih, mlajših od dveh let, uporaba zdravila ORENCIA ni relevantna.
English: ORENCIA solution for injection in pre-filled syringe is used in children and adolescents aged 2 to 17 years when a previous disease-modifying medicine has not worked well or is not suitable for them.
Slovenian: Zdravilo ORENCIA raztopina za injiciranje v napolnjeni injekcijski brizgi uporabljamo pri otrocih in mladostnikih, starih od 2 do 17 let, če odziv na predhodno zdravljenje z imunomodulirajočim zdravilom ni bil zadosten ali pa zdravljenje z njim ni bilo primerno.
English: In studies I, II, and V the efficacy and safety of abatacept compared to placebo were assessed in patients with an inadequate response to methotrexate and who continued on their stable dose of methotrexate.
Slovenian: V študijah I, II in V so učinkovitost in varnost abatacepta v primerjavi s placebom vrednotili pri bolnikih z nezadostnim odzivom na metotreksat.
English: With your other hand, pinch the cleaned skin.
Slovenian: Z drugo roko očiščeno kožo stisnite v gubo.
English: Complete drug withdrawal led to loss of remission (return to disease activity) in all three treatment arms (abatacept with methotrexate, abatacept or methotrexate alone) in a majority of patients (Table 3).
Slovenian: Pri popolni odtegnitvi zdravila je pri večini bolnikov v vseh skupinah zdravljenja (abatacept z metotreksatom, samo abatacept ali samo metotreksat) prišlo do izgube remisije (povrnitev aktivnosti bolezni) (preglednica 3).
English: Greater improvement (p < 0.001) in DAS28 was observed with abatacept and with infliximab compared to placebo at six months in the placebo-controlled portion of the trial; the results between the abatacept and infliximab groups were similar.
Slovenian: Po šestih mesecih je bilo v s placebom nadziranem delu preskušanja opaženo večje izboljšanje (p < 0,001) rezultata DAS28 pri abataceptu in infliksimabu kot pri placebu.
English: - To minimise foam formation in solutions of ORENCIA, the vial should be rotated with gentle swirling until the contents are completely dissolved.
Slovenian: - Da bi bilo penjenje raztopine zdravila ORENCIA čim manjše, vialo nežno obračajte, dokler se vsebina popolnoma ne raztopi.
English: Medicinal products that affect the immune system, including abatacept, may blunt the effectiveness of some immunisations (see section 4.5).
Slovenian: Zdravila, ki vplivajo na imunski sistem, vključno z abataceptom, lahko zmanjšajo učinkovitost nekaterih cepljenj (glejte poglavje 4.5).
English: There have been reports of tuberculosis in patients receiving ORENCIA (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom ORENCIA, so poročali o pojavu tuberkuloze (glejte poglavje 4.8).
English: In abatacept-treated patients in studies II and III, statistically significant improvement in the ACR 20 response versus placebo was observed after administration of the first dose (day 15), and this improvement remained significant for the duration of the studies.
Slovenian: Pri bolnikih, ki so v študijah II in III prejemali abatacept, so po aplikaciji prvega odmerka (15. dan) opazili statistično pomembno izboljšanje odziva ACR 20 v primerjavi s placebom.
English: Transparent Tip
Slovenian: Pregledno okence
English: Complete drug withdrawal led to loss of remission (return to disease activity) in all three treatment arms (abatacept with methotrexate, abatacept or methotrexate alone) in a majority of patients (Table 4).
Slovenian: Pri popolni odtegnitvi zdravila je pri večini bolnikov v vseh skupinah zdravljenja (abatacept z metotreksatom, samo abatacept ali samo metotreksat) prišlo do izgube remisije (povrnitev aktivnosti bolezni) (preglednica 4).
English: Patients switching from ORENCIA intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
Slovenian: Bolniki, ki bodo z intravenskega zdravljenja z zdravilom ORENCIA prešli na subkutano zdravljenje, morajo prvi subkutani odmerek prejeti namesto naslednjega predvidenega intravenskega odmerka.
English: In study SC-III, the proportion of subjects with a HAQ response as a measure of clinically meaningful improvement in physical function (reduction from baseline in HAQ-D1 score of ≥ 0.3) was greater for the abatacept+ MTX group vs. the MTX group at month 12 (65.5% vs 44.0%, respectively; treatment difference vs. MTX group of 21.6% [95% CI: 8.3, 34.9]).
Slovenian: V študiji SC-III je bil delež oseb z odzivom HAQ kot merilom klinično pomembnega izboljšanja fizične funkcije (zmanjšanje od izhodiščne ocene HAQ-DI za ≥ 0,3) v 12. mesecu večji v skupini abatacept+ MTX v primerjavi s skupino z MTX (65,5 % v primerjavi s 44,0 %; razlika zdravljenja v primerjavi s skupino z MTX 21,6 % [95 % IZ: 8,3; 34,9]).
English: The total content (1 mL) of the pre-filled pen should be administered as a subcutaneous injection only.
Slovenian: Injicirati je treba celotno vsebino (1 ml) napolnjenega injekcijskega peresnika.
English: − If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Slovenian: − Če se pojavijo simptomi, ki kažejo na okužbo, npr. zvišana telesna temperatura, trdovraten kašelj, hujšanje ali ravnodušnost, nemudoma poiščite zdravniško pomoč.
English: Study SC-I: Pre-filled pen sub-study
Slovenian: Študija SC-I: Podštudija uporabe napolnjenega injekcijskega peresnika
English: Store unused syringes in the refrigerator in the original carton.
Slovenian: Neuporabljene napolnjene injekcijske brizge morate vedno shranjevati v hladilniku v originalni ovojnini.
English: Abatacept 10 mg/kg IV N=40
Slovenian: Abatacept 10 mg/kg i.v.
English: After 24 months, adverse reactions were reported in 41.5% (132/318) and 50% (164/328) of abatacept and adalimumab-treated patients.
Slovenian: V 24 mesecih so o neželenih učinkih poročali pri 41,5 % (132/318) bolnikov, ki so se zdravili z abataceptom, in 50 % (164/328) bolnikov, ki so se zdravili z adalimumabom.
English: In study SC-III, abatacept subcutaneous was evaluated in combination with methotrexate (MTX), or as abatacept monotherapy, and compared to MTX monotherapy in induction of remission following 12 months of treatment, and the possible maintenance of drug-free remission after complete drug withdrawal, in adult MTX-naive patients with highly active early, rheumatoid arthritis (mean DAS28-CRP of 5.4; mean symptom duration less than 6.7 months) with poor prognostic factors for rapidly progressive disease (e.g., anti-citrullinated protein antibodies [ACPA+], as measured by antiCCP2 assay, and/or RF+, baseline joint erosions).
Slovenian: V študiji SC-III so vrednotili subkutano uporabo abatacepta v kombinaciji z metotreksatom (MTX) ali abatacepta v monoterapiji v primerjavi z uporabo MTX v monoterapiji pri indukciji remisije po 12-mesečnem zdravljenju ter morebitno ohranitev remisije v času brez uporabe zdravila po popolni odtegnitvi zdravila, in sicer pri odraslih bolnikih, ki se predhodno še niso zdravili z MTX, z močno aktivnim zgodnjim revmatoidnim artritisom (povprečna vrednost DAS28-CRP 5,4; povprečna vrednost trajanja simptomov manj kot 6,7 meseca) s slabimi prognostičnimi dejavniki za hitro napredovanje bolezni (npr. protitelesa proti citruliranemu proteinu [ACPA+], izmerjena z anti-CCP2 testom, in/ali RF+, izhodiščne erozije sklepa).
English: ORENCIA is available in the following presentations: - pack of 4 pre-filled pens and multipack containing 12 pre-filled pens (3 packs of 4).
Slovenian: Zdravilo ORENCIA je na voljo v naslednjih pakiranjih: - pakiranje s 4 napolnjenimi injekcijskimi peresniki in skupno pakiranje, ki vsebuje 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4).
English: Subjects entering the long term extension after 1 year of double blind treatment all received abatacept treatment and radiographic progression was investigated through year 5.
Slovenian: Vse osebe, ki so bile po enem letu dvojno slepega zdravljenja vključene v dolgoročno podaljšano fazo študije, so prejemale abatacept.
English: Plunger head
Slovenian: Glava bata
English: During the initial double blind 6 months period (shortterm period), the overall immunogenicity frequency to abatacept was 1.1% (8/725) and 2.3% (16/710) for the subcutaneous and intravenous groups, respectively.
Slovenian: Med začetnim dvojno slepim 6-mesečnim obdobjem (kratkoročno obdobje) je bila celokupna pogostnost imunogenosti v skupini, ki je prejemala abatacept subkutano 1,1% (8/725), v skupini, ki je abatacept prejemala intravensko pa 2,3% (16/710).
English: Medicinal products that affect the immune system, including abatacept, may blunt the effectiveness of some immunisations (see sections 4.4 and
Slovenian: Zdravila, ki vplivajo na imunski sistem, vključno z abataceptom, lahko zmanjšajo učinkovitost nekaterih cepljenj (glejte poglavji 4.4 in 4.6).
English: Significantly more placebo recipients flared during Period B (33/62; 53%) than those maintained on abatacept (12/60; 20%; chi-square p<0.001).
Slovenian: Med obdobjem B se je poslabšanje bolezni pojavilo pri pomembno večjem številu bolnikov, ki so prejemali placebo (33/62; 53 %), kot pri tistih, ki so ostali na abataceptu (12/60; 20 %; hi-kvadrat p<0,001).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na napolnjeno injekcijsko brizgo, kar v bistvu pomeni “brez natrija”.
English: Paediatric patients weighing 75 kg or more should be administered ORENCIA following the adult dosing regimen, not to exceed a maximum dose of 1,000 mg. ORENCIA should be administered as a 30-minute intravenous infusion.
Slovenian: Pri pediatričnih bolnikih s telesno maso 75 kg ali večjo je treba upoštevati režim odmerjanja zdravila ORENCIA za odrasle, vendar pa odmerek ne sme preseči največjega odmerka, to je 1.000 mg.
English: Do not use this medicine if the liquid is cloudy or discoloured, or has large particles.
Slovenian: Zdravila ne uporabljajte, če je tekočina motna, drugače obarvana ali vsebuje večje delce.
English: - Do not store any unused portion of the infusion solution for reuse.
Slovenian: - Neporabljene vsebine raztopine za infundiranje ne shranjujte za ponovno uporabo.
English: In this study, the steady-state concentrations of abatacept were dose-related.
Slovenian: V tej študiji so bile koncentracije abatacepta v stanju dinamičnega ravnovesja odvisne od odmerka.
English: 87.5 mg/0.7 mL light blue plunger
Slovenian: 87,5 mg/0,7 ml svetlomoder bat
English: Hepatitis: Anti-rheumatic therapies have been associated with hepatitis B reactivation.
Slovenian: Hepatitis: Protirevmatična zdravljenja so bila povezana z reaktivacijo hepatitisa B. Opraviti je treba presejalno testiranje na virusni hepatitis v skladu z objavljenimi smernicami.
English: The respective values for ACR 20 at 24 months were 59.7% (190/318) for the abatacept SC group and 60.1% (197/328) for the adalimumab SC group.
Slovenian: Ustrezne vrednosti ACR 20 so bile po 24 mesecih v skupini z abataceptom s.c. dosežene pri 59,7 % (190/318) bolnikov, v skupini z adalimumabom s.c. pa pri 60,1 % (197/328) bolnikov.
English: In study PsA-II, 424 patients were randomised 1:1 to receive in a double-blind manner weekly doses of subcutaneous placebo or abatacept 125 mg without a loading dose for 24 weeks, followed by openlabel abatacept 125 mg subcutaneous weekly.
Slovenian: V študiji PsA-II so 424 bolnikov randomizirali v razmerju 1:1 na 24-tedensko dvojno slepo prejemanje tedenskih subkutanih odmerkov placeba ali abatacepta (125 mg) brez polnilnega odmerka.
English: Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
Slovenian: Iglo injekcijske brizge zabodite v vialo skozi sredino gumijastega zamaška in curek vode za injekcije usmerite v stekleno steno viale.
English: Acute infusion-related events that were reported in > 0.1% and ≤ 1% of patients treated with abatacept included cardiopulmonary symptoms such as hypotension, decreased blood pressure, tachycardia, bronchospasm, and dyspnea; other symptoms included myalgia, nausea, erythema, flushing, urticaria, hypersensitivity, pruritus, throat tightness, chest discomfort, chills, infusion site extravasation, infusion site pain, infusion site swelling, infusion related reaction, and rash.
Slovenian: Akutni neželeni učinki, povezani z infundiranjem, o katerih so poročali pri > 0,1% in ≤ 1% bolnikov, ki so prejemali abatacept, so vključevali kardiopulmonalne simptome, kot so hipotenzija, znižanje krvnega tlaka, tahikardija, bronhospazem in dispneja, drugi simptomi so vključevali mialgijo, navzeo, eritem, vročinske oblive, urtikarijo, preobčutljivost, srbenje, stiskanje v žrelu, neugodje v prsnem košu, mrzlico, ekstravazacijo na mestu infundiranja, bolečino na mestu infundiranja, oteklino na mestu infundiranja, reakcijo povezano z infundiranjem in izpuščaj.
English: - Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
Slovenian: - Iglo injekcijske brizge zabodite v vialo skozi sredino gumijastega zamaška in curek vode za injekcije usmerite v stekleno steno viale.
English: Change injection site Each week you can use the same area of your body, but use a different injection site in that area.
Slovenian: Menjavanje mesta injiciranja Zdravilo lahko vsak teden injicirate na istem predelu, vendar pa na izbranem predelu zdravilo vedno injicirajte na drugo mesto.
English: Hypersensitivity was reported uncommonly.
Slovenian: O preobčutljivosti so poročali občasno.
English: What you need to know before you use ORENCIA
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo ORENCIA