natgillin/translations-raw huggingface dataset:
10 Greater improvements were seen with abatacept than with placebo in other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Pri drugih merilih aktivnosti revmatoidnega artritisa, ki niso vključena v kriterije odziva ACR, npr. jutranja okorelost, so pri uporabi abatacepta opazili večje izboljšanje kot pri placebu.
DAS28 response Disease activity was also assessed using the Disease Activity Score 28 (DAS28 ESR).
DAS28 odziv Aktivnost bolezni so vrednotili tudi na osnovi ocene aktivnosti bolezni 28 (DAS28 ESR; “ Disease Activity Score 28 ”).
There was a significant improvement of DAS in Studies II, III, and V as compared to placebo.
V študijah II, III in V so opazili pomembno izboljšanje DAS v primerjavi s placebom.
Study V: abatacept or infliximab versus placebo A randomized, 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).
Študija V: abatacept ali infliksimab v primerjavi s placebom 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).
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.
V skupinah z abataceptom in infliksimabom so bili rezultati podobni.
Further improvement was observed at 12 months with abatacept.
Po 12- ih mesecih so pri abataceptu opazili nadaljnje izboljšanje.
At 6 months, the incidence of AE of infections were 48.1% (75), 52.1% (86), and 51.8% (57) and the incidence of serious AE of infections were 1.3% (2), 4.2% (7), and 2.7% (3) for abatacept, infliximab and placebo groups, respectively.
Po 6 mesecih je bila pojavnost okužb kot neželenega učinka v skupini z abataceptom 48, 1% (75), v skupini z infliksimabom 52, 1% (86) in v skupini s placebom 51, 8% (57).
At 12 months, the incidence of AE of infections were 59.6% (93), 68.5% (113), and the incidence of serious AE of infections were 1.9% (3) and 8.5% (14) for abatacept and infliximab groups, respectively.
Po 12- ih mesecih je bila pojavnost okužb kot neželenega učinka v skupini z abataceptom 59, 6% (93) in v skupini z infliksimabom 68, 5% (113).
Radiographic response Structural joint damage was assessed radiographically over a two-year period in Study II.
Radiografski odziv Strukturne poškodbe sklepa so vrednotili radiološko med dveletnim obdobjem v študiji II.
The results were measured using the Genant-modified total Sharp score (TSS) and its components, the erosion score and joint space narrowing (JSN) score.
Rezultate so vrednotili na osnovi skupne Sharpove ocene, modificirane po Genantu (TSS; “ Genant- modified total Sharp score ”) in njenih komponent, ocene erozije in ocene zožitve sklepne špranje (JSN; “ joint space narrowing ”).
The baseline median TSS was 31.7 in abatacept-treated patients and 33.4 in placebo-treated patients.
Srednja izhodiščna vrednost TSS je bila pri bolnikih, ki so prejemali abatacept 31, 7, pri bolnikih, ki so prejemali placebo, pa 33, 4.
Abatacept/ methotrexate reduced the rate of progression of structural damage compared to placebo/ methotrexate after 12 months of treatment as shown in Table 4.
Zmanjšanje obsega napredovanja strukturnih poškodb z abataceptom/ metotreksatom v primerjavi s placebom/ metotreksatom po 12 mesecih zdravljenja je prikazano v tabeli 4.
The rate of progression of structural damage in year 2 was significantly lower than that in year 1 for patients randomized to abatacept (p < 0.0001).
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).
Mean Radiographic Changes Over 12 Months in Study II Abatacept/ MTX Placebo/ MTX
Srednje vrednosti radiografskih sprememb med 12 meseci v študiji II Abatacept/ MTX Placebo/ MTX P- vrednosta
Parameter Total Sharp score Erosion score JSN score a
Parameter Skupna Sharpova ocena
n = 391 n = 195 P-valuea 1.21 2.32 0.012 0.63 1.14 0.029 0.58 1.18 0.009
n= 391 n= 195 1, 21 2, 32 0, 012
Based on non-parametric analysis.
Na osnovi neparametrične analize.
Physical function response Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) in Studies II, III, IV and V and the modified HAQ-DI in Study I.
Odziv v obliki fizične funkcije Izboljšanje fizične funkcije je bilo v študijah II, III, IV in V ovrednoteno z indeksom nezmožnosti na osnovi vprašalnika za oceno zdravstvenega stanja (HAQ- DI; “ Health Assessment Questionnaire Disability Index ”), v študiji I pa z modificiranim indeksom HAQ- DI.
The results from Studies II and III are shown in Table 5.
Rezultati iz študij II in III so prikazani v tabeli 5.
Improvement in Physical Function in Placebo-Controlled Trials Inadequate Response to Inadequate Response Methotrexate TNF Blocking Agent Study II Study III
Nezadosten odziv na Nezadosten odziv metotreksat zaviralec TNF
HAQc Disability
Indeks nezmožnosti
Abatacepta Placebo Abatacepta
Abatacept Placebo
Index Baseline (Mean) Mean Improvement from Baseline
Izhodišče (povprečje)
+MTX 1.69 (n = 422)
(n = 422)
+MTX 1.69 (n = 212)
= 212)
+DMARDsb 1.83 (n = 249)
(n = 249)
+DMARDsb 1.82 (n = 130)
= 130)
0.59*** (n = 420)
(n = 420) 0, 66 ***
0.40 (n = 211)
= 211) 0, 37
0.11 (n = 130)
= 130) NAe
Month 12 Proportion of patients with a clinically meaningful improvementd
Odstotek bolnikov s klinično pomembnim izboljšanjemd
0.66*** (n = 422)
(n = 422)
0.37 (n = 212)
= 212)
Month 6 Month 12
6. mesec
61%*** 64%***
61% ***
45% 39%
45%
47%*** NAe
47% ***
23% NAe
23%
p < 0.001, abatacept vs. placebo. a Fixed dose approximating 10 mg/ kg (see section 4.2). b Concurrent DMARDs included one or more of the following: methotrexate, chloroquine/ hydroxychloroquine, sulfasalazine, leflunomide, azathioprine, gold, and anakinra. c Health Assessment Questionnaire; 0 = best, 3 = worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. d Reduction in HAQ-DI of ≥ 0.3 units from baseline. e After 6 months, patients were given the opportunity to enter into an open-label study.
p < 0, 001, abatacept v primerjavi s placebom. a Fiksni odmerek približno 10 mg/ kg (glejte poglavje 4. 2).. 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. c Vprašalnik za oceno zdravstvenega stanja; 0 = boljše, 3 = slabše; 20 vprašanj; 8 kategorij: oblačenje in nega, vstajanje, hranjenje, hoja, higiena, doseganje stvari, moč prijemanja in aktivnosti. d Zmanjšanje indeksa HAQ- DI za ≥ 0, 3 enote od izhodišča. e Po 6 mesecih so imeli bolniki možnost vključitve v odprto študijo.
During the open-label period of Studies I, II, and III, the improvement in physical function has been maintained through 48, 24, and 18 months, respectively.
Med odprtim obdobjem študije I se je izboljšanje fizične funkcije ohranilo 48 mesecev, med odprtim obdobjem študije II 24 mesecev in med odprtim obdobjem študije III 18 mesecev.
Health-related outcomes and quality of life 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 povezani izidi in kvaliteta življenja Z zdravstvenim stanjem povezana kvaliteta življenja je bila v študijah I, II in III ovrednotena s SF- 36 vprašalnikom (“ SF- 36 questionnaire ”) po 6 mesecih, v študijah I in II pa tudi po 12 mesecih.
In these studies, clinically and statistically significant improvement was observed in the abatacept group as compared with the placebo group in all 8 domains of the SF-36 (4 physical domains: physical function, role physical, bodily pain, general health; and 4 mental domains: vitality, social function, role emotional, mental health), as well as the Physical Component Summary and the Mental Component Summary.
V teh študijah so v primerjavi s skupino, ki je prejemala placebo, v skupini, ki je prejemala abatacept, opazili klinično in statistično pomembno izboljšanje v vseh 8 domenah SF- 36 (4 fizične domene: fizična funkcija, fizične vloga, telesna bolečina, splošno zdravstveno stanje in 4 duševne domene: vitalnost, socialna funkcija, čustvena vloga, duševno zdravje), kot tudi pri povzetku telesnih in duševnih komponent.
After multiple intravenous infusions (days 1, 15, 30, and every 4 weeks thereafter), the pharmacokinetics of abatacept in rheumatoid arthritis patients showed dose-proportional increases of Cmax and AUC over the dose range of 2 mg/ kg to 10 mg/ kg.
Po ponavljajočih se intravenskih infuzijah (1., 15. in 30. dan in nato vsake 4 tedne), je farmakokinetika abatacepta pri bolnikih z revmatoidnim artritisom kazala z odmerkom proporcionalno povečevanje Cmax in AUC v razponu odmerkov od 2 mg/ kg do 10 mg/ kg.
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.
The mean distribution volume (Vss) was 0.07 l/ kg and ranged from 0.02 to 0.13 l/ kg.
Srednji volumen porazdelitve (Vss) je bil 0, 07 l/ kg, gibal pa se je od 0, 02 do 0, 13 l/ kg.
The systemic clearance was approximately 0.22 ml/ h/ kg.
Sistemski očistek je bil približno 0, 22 ml/ h/ kg.
Mean steady-state trough concentrations were approximately 25 μ g/ ml, and mean Cmax concentrations were approximately 290 μ g/ ml.
Povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja so bile približno 25 μg/ ml, povprečne Cmax koncentracije pa približno 290 μg/ ml.
No systemic accumulation of abatacept occurred upon continued repeated treatment with 10 mg/ kg at monthly intervals in rheumatoid arthritis patients.
13 z odmerkom 10 mg/ kg v mesečnih intervalih pri bolnikih z revmatoidnim artritisom ni prihajalo do sistemskega kopičenja abatacepta.
Age and gender (when corrected for body weight) did not 12 affect clearance.
Starost in spol (korigirani na telesno maso) na očistek nista vplivali.
Methotrexate, NSAIDs, corticosteroids, and TNF blocking agents were not found to influence abatacept clearance.
Metotreksat, nesteroidna protivnetna zdravila, kortikosteroidi in zaviralci TNF niso vplivali na očistek abatacepta.
The pharmacokinetics of abatacept have not been studied in children and adolescents.
Pri otrocih in mladostnikih farmakokinetika abatacepta ni raziskana.
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.
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.
No evidence of lymphomas or preneoplastic morphological changes was observed, despite the presence of a virus, lymphocryptovirus, which is known to cause such lesions in immunosuppressed monkeys within the time frame of this study.
V časovnem okviru študije niso opazili znakov limfomov ali preneoplastičnih morfoloških spremembah, kljub prisotnosti limfokriptovirusa, ki pri imunosupresivnih opicah dokazano povzroča tovrstne spremembe.
The relevance of these findings to the clinical use of ORENCIA is unknown.
Pomen teh ugotovitev za klinično uporabo zdravila ORENCIA ni znan.
Embryo-foetal development studies were conducted with abatacept in mice, rats, and rabbits at doses up to 20 to 30 times a human 10 mg/ kg dose and no undesirable effects were observed in the offspring.
Pri potomcih niso opazili neželenih učinkov.
In rats and rabbits, abatacept exposure was up to 29-fold a human 10 mg/ kg exposure based on AUC.
Pri podganah in kuncih je bila izpostavljenost abataceptu na osnovi AUC do 29- krat večja od izpostavljenosti človeka pri odmerku 10 mg/ kg.
In a pre- and postnatal development study with abatacept in rats, no undesirable effects were observed in pups of dams given abatacept at doses up to 45 mg/ kg, representing 3-fold a human 10 mg/ kg exposure based on AUC.
V študijah vplivov abatacepta na prenatalni in postnatalni razvoj pri mladičih podgan, ki so prejemale abatacept v odmerkih do 45 mg/ kg, kar je na osnovi AUC 3- krat večja izpostavljenost od izpostavljenosti človeka pri odmerku 10 mg/ kg, niso opazili neželenih učinkov.
At a dose of 200 mg/ kg, representing 11-fold a human exposure at 10 mg/ kg based on AUC, limited changes in immune function (a 9-fold increase in the mean T-cell-dependent antibody response in female pups and inflammation of the thyroid of 1 female pup out of 10 male and 10 female pups evaluated at this dose) were observed.
Pri odmerku 200 mg/ kg, kar je na osnovi AUC 11- krat večja izpostavljenost od izpostavljenosti človeka pri odmerku 10 mg/ kg, so opazili omejene spremembe imunske funkcije (9- kratno povečanje srednjega T- celičnega protitelesnega odziva pri mladičih ženskega spola in vnetje ščitnice pri 1 mladiču ženskega spola od 10 mladičev moškega in 10 mladičev ženskega spola, pri katerih je bil ta odmerek ovrednoten).
Maltose Sodium dihydrogen phosphate monohydrate Sodium chloride
Maltoza Natrijev dihidrogenfosfat monohidrat Natrijev klorid
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).
After reconstitution: chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Po rekonstituciji: dokazano je bilo, da je zdravilo kemično in fizikalno stabilno 24 ur, če se ga shranjuje pri temperaturi od 2°C - 8°C.
13 After dilution: when the reconstituted solution is diluted immediately, the chemical and physical in-use stability of the diluted infusion solution has been demonstrated for 24 hours at 2°C - 8°C.
Po redčenju: dokazano je bilo, da je razredčena raztopina za infundiranje kemično in fizikalno stabilna 24 ur, če se jo shranjuje pri temperaturi od 2°C - 8°C in je bila razredčena takoj po rekonstituciji.
250 mg powder in a vial (Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium) with a silicone-free syringe (polyethylene).
250 mg praška v viali (steklo tipa 1) z zamaškom (halobutilna guma) in dvižno zaporko (aluminij) z injekcijsko brizgo brez silikona (polietilen).
Packs of 1, 2, or 3 vials (each 15 ml) and 1, 2, or 3 silicone-free syringes, respectively.
Pakiranja po 1, 2 ali 3 viale (vsaka 15 ml) in 1, 2 ali 3 injekcijske brizge, ki ne vsebujejo silikona.
Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
Še posebej je treba poskrbeti za aseptične pogoje.
Reconstitution 1.
Rekonstitucija 1.
Determine the dose and the number of ORENCIA vials needed (see section 4.2).
Določite odmerek in potrebno število vial zdravila ORENCIA (glejte poglavje 4. 2).
Under aseptic conditions, reconstitute each vial with 10 ml of water for injections, using the silicone free-disposable syringe provided with each vial (see section 6.2) and an 18-21 gauge needle.
Pri tem uporabite injekcijsko brizgo za enkratno uporabo, ki ne vsebuje silikona in je priložena vsaki viali (glejte poglavje 6. 2) in injekcijsko iglo velikosti 18- 21.
- Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream
- Iglo injekcijske brizge zabodite v vialo skozi sredino gumijastega zamaška in curek vode za injekcije
of water for injections to the glass wall of the vial.
usmerite v stekleno steno viale.
- 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.
- To minimise foam formation in solutions of ORENCIA, the vial should be rotated with gentle
- Da bi bilo penjenje raztopine zdravila ORENCIA čim manjše, vialo nežno obračajte, dokler se
swirling until the contents are completely dissolved.
vsebina popolnoma ne raztopi.
- Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any
- Ko se prašek popolnoma raztopi, s pomočjo injekcijske igle iz viale odstranite vso morebiti prisotno
foam that may be present.
peno.
Do not use if opaque
Če opazite motne delce,
particles, discolouration, or other foreign particles are present.
drugačno obarvanje ali tujke, raztopine ne uporabljajte.
Dilution 3.
Redčenje 3.
Immediately after reconstitution, the product must be further diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection.
Takoj po rekonstituciji morate zdravilo nadalje razredčiti do 100 ml z 0, 9% raztopino natrijevega klorida (9 mg/ ml) za injiciranje.
- From a 100 ml infusion bag or bottle, withdraw a volume of sodium chloride 9 mg/ ml (0.9%)
- Iz 100- ml infuzijske vreče ali steklenice odstranite volumen 0, 9% raztopine natrijevega klorida
solution for injection equal to the volume of the reconstituted vials (for 2 vials remove 20 ml, for 3 vials remove 30 ml, for 4 vials remove 40 ml).
(9 mg/ ml) za injiciranje, ki je enak volumnu vial po rekonstituciji (za 2 viali odstranite 20 ml, za 3 viale odstranite 30 ml, za 4 viale odstranite 40 ml).
- Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using
- V infuzijsko vrečo ali steklenico iz vsake viale počasi dodajte rekonstituirano raztopino zdravila
the same silicone-free disposable syringe provided with each vial.
Pri tem uporabite isto injekcijsko brizgo za enkratno uporabo, ki ne vsebuje silikona in je priložena vsaki viali.
- Gently mix.
- Nežno premešajte.
The concentration of the fully diluted ORENCIA solution in the infusion bag or bottle
Koncentracija popolnoma razredčene ORENCIA raztopine za infundiranje v
will be approximately 5, 7.5, or 10 mg of abatacept per ml of solution depending on whether 2, 3, or 4 vials of abatacept are used.
infuzijski vreči ali steklenici bo približno 5, 7, 5 ali 10 mg abatacepta na ml raztopine, odvisno od števila uporabljenih vial abatacepta (2, 3 ali 4 viale).
- Any unused portion in the vials must be immediately discarded in accordance with local
- Neporabljeno vsebino vial morate nemudoma zavreči v skladu z lokalnimi predpisi.
When reconstitution and dilution are performed under aseptic conditions ORENCIA infusion solution can be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C.
Če sta rekonstitucija in redčenje izvedena v aseptičnih pogojih, se ORENCIA raztopino za infundiranje lahko uporabi takoj ali v 24 urah, če se jo shrani pri temperaturi od 2°C do 8°C.
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 μ m).
Vso količino popolnoma razredčene raztopine ORENCIA morate aplicirati v obliki 30- minutne infuzije preko infuzijskega sistema in sterilnega apirogenega filtra, ki minimalno veže proteine (velikost por 0, 2 do 1, 2 μm).
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
Bristol- Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Velika Britanija
Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 USA
Bristol- Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 ZDA
101 International Drive Portsmouth, NH 03801-2815 USA
101 International Drive Portsmouth, NH 03801- 2815 ZDA
Contrada Fontana del Ceraso 03012 Anagni Italy
Contrada Fontana del Ceraso 03012 Anagni Italija
The CHMP considered that a Patient Alert Card should be provided and this is included in Annex III.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je treba zagotoviti opozorilni kartonček za bolnika, ki je sestavni del Dodatka III.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora pred začetkom trženja zdravila vzpostaviti delujoči sistem farmakovigilance.
Risk Management plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Načrt upravljanja tveganja Imetnik dovoljenja za promet z zdravilom mora izvesti študije in dodatne farmakovigilančne aktivnosti, ki so določene v načrtu farmakovigilance.
An updated Risk Management Plan should be provided as per CHMP Guideline on Risk Management Systems for medicinal products for human use.
Posodobljen načrt upravljanja tveganja mora biti pripravljen v skladu s smernicami Odbora za zdravila za uporabo v humani medicini (CHMP) o sistemih upravljanja tveganja za zdravila za humano uporabo.
ORENCIA 250 mg powder for concentrate for solution for infusion Abatacept
ORENCIA 250 mg prašek za koncentrat za raztopino za infundiranje abatacept
1 vial 1 sterile silicone-free syringe
1 viala 1 sterilna injekcijska brizga brez silikona
2 vials 2 sterile silicone-free syringes
2 viali 2 sterilni injekcijski brizgi brez silikona
3 vials 3 sterile silicone-free syringes
3 viale 3 sterilne injekcijske brizge brez silikona
Intravenous use after reconstitution and dilution Read the package leaflet before reconstitution and use.
Pred rekonstitucijo in uporabo preberite priloženo navodilo.
20 Read the package leaflet for the shelf-life of the reconstituted product.
Za rok uporabnosti zdravila po rekonstituciji glejte priloženo navodilo za uporabo.
TRAY LABEL
NALEPKA NA PODSTAVKU
ORENCIA 250 mg powder for concentrate for solution for infusion Abatacept Intravenous use
ORENCIA 250 mg prašek za koncentrat za raztopino za infundiranje abatacept Intravenska uporaba.
250 mg of abatacept
250 mg abatacepta
23 PATIENT ALERT CARD TEXT
24 BESEDILO OPOZORILNEGA KARTONČKA ZA BOLNIKA
Orencia Patient Alert Card
Orencia – Opozorilni kartonček za bolnika
This alert card contains important safety information that you need to be aware of before you are given ORENCIA and during treatment with ORENCIA. • Show this card to any doctor involved in
Opozorilni kartonček vsebuje pomembne informacije o varnosti, ki se jih morate zavedati pred začetkom zdravljenja in med zdravljenjem z zdravilom ORENCIA. • Opozorilni kartonček pokažite vsakemu
If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Če se pojavijo simptomi, ki kažejo na okužbo, npr. zvišana telesna temperatura, trdovraten kašelj, hujšanje ali ravnodušnost, nemudoma poiščite zdravniško pomoč.
Dates of ORENCIA Treatment:
zdravniku, ki sodeluje pri vašem zdravljenju.
Infections Start:
Začetek:
ORENCIA increases the risk of getting ____________________ infections.
Okužbe ____________________ Zdravilo okužbe.
Most recent:
ORENCIA
- You should not be treated with ORENCIA
povečuje
if you have severe infection. - You should be screened for certain infections prior to treatment with
za
____________________
Zadnje zdravljenje: ____________________
ORENCIA, according to relevant guidelines.
Če imate hudo okužbo,
Tuberculosis (TB):
ORENCIA ne smete prejeti.
The safety of ORENCIA in individuals with latent TB is unknown.
Za več informacij glejte navodilo za uporabo zdravila ORENCIA.