natgillin/translations-raw huggingface dataset:
Fatigue, asthenia, local injection site reactions, systemic injection reactions* Uncommon Influenza like illness, weight increased
Splošne težave in spremembe na mestu aplikacije pogosti utrujenost, astenija, lokalne reakcije na mestu injiciranja, sistemske reakcije na injiciranje*
ORENCIA should be administered weekly at a dose of 125 mg by subcutaneous (SC) injection without the need for an intravenous (IV) loading dose.
Zdravilo ORENCIA je treba uporabljati tedensko v odmerku 125 mg v obliki subkutane (s.c.) injekcije.
MRI Osteitis/Bone Oedema Score
MRI ocena erozije MRI ocena osteitisa/edema kostnine
Ask your doctor, nurse, or pharmacist about national and local laws regarding the proper disposal of medical products that contain needles.
O odstranjevanju medicinskih pripomočkov z iglami v skladu z nacionalnimi in lokalnimi predpisi se posvetujte s svojim zdravnikom, z medicinsko sestro ali s farmacevtom.
In the open-label extension of studies I, II, III, VI, and SC-I durable and sustained ACR 20, 50, and 70 responses have been observed through 7 years, 5 years, 5 years, 2 years, and 5 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, v odprtem podaljšku študije VI 2 leti zdravljenja z abataceptom in v odprtem podaljšku študije SC-I 5 let zdravljenja z abataceptom.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 125 mg of abatacept in one mL.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine v napolnjenem injekcijskem peresniku vsebuje 125 mg abatacepta.
0.7 mL Fill line
0,7 ml oznaka polnjenja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 1 AND 4 PRE-FILLED SYRINGES 1.
ŠKATLA ZA PAKIRANJA Z 1 IN 4 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI 1.
ORENCIA 125 mg solution for injection in pre-filled syringe
ORENCIA 125 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities.
Če se ga ne zdravi, ima lahko resne posledice, kot so poškodba sklepov, invalidnost in otežitev vsakodnevnih opravil.
0.4 mL Fill line
0,4 ml oznaka polnjenja
Don't try to self-inject until you are sure that you understand how to prepare and give the injection.
Dokler niste povsem prepričani, da popolnoma obvladate pripravo in injiciranje, si zdravila ne smete injicirati sami.
Paediatric population Polyarticular juvenile idiopathic arthritis
Pediatrična populacija Poliartikularni juvenilni idiopatski artritis
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjeni injekcijski brizgi 4 napolnjene injekcijske brizge
Common (may affect up to 1 in 10 people): infections of lungs, urinary infections, painful skin blisters (herpes), flu headache, dizziness high blood pressure cough abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting rash fatigue, weakness, injection site reactions abnormal liver function tests.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužbe pljuč, okužbe sečil, boleči kožni mehurji (herpes), gripa, glavobol, omotica, visok krvni tlak, kašelj, bolečine v trebuhu, driska, slabost, želodčne težave, vnetje ustne sluznice, bruhanje, izpuščaj, utrujenost, oslabelost, reakcije na mestu injiciranja, nenormalni izvidi preiskav delovanja jeter.
As in study SC-I, there was no effect of immunogenicity on safety or efficacy.
Imunogenost ni vplivala na varnost ali učinkovitost zdravljenja, podobno kot v študiji SC-1.
If you miss receiving ORENCIA when you are supposed to, ask your doctor when to schedule your next dose.
Če ste pozabili in niste prejeli zdravila ORENCIA Če niste prejeli predvidenega odmerka zdravila ORENCIA, se o prejemu naslednjega odmerka posvetujte z zdravnikom.
Comparable trough concentrations across weight tiers and age groups were achieved by the body-weight-tiered subcutaneous dosing regimen.
Pri subkutanem režimu odmerjanja na osnovi telesne mase so bile dosežene primerljive najmanjše koncentracije po skupinah glede na telesno maso in starost.
Have your additional injection supplies ready before you inject.
Pred injiciranjem zdravila si morate vedno pripraviti dodatne potrebščine, ki jih boste potrebovali pri injiciranju.
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.
Odziv ACR 20 je bil ugotovljen pri 84% bolnikov, odziv ACR 50 pri 61% bolnikov in odziv ACR 70 pri 40% bolnikov.
In study III, ACR responses were assessed at 5 years in 91 patients with 74% ACR 20 responses, 51% ACR 50 responses, and 23% ACR 70 responses.
Odziv ACR 20 je bil ugotovljen pri 74% bolnikov, odziv ACR 50 pri 51% bolnikov in odziv ACR 70 pri 23% bolnikov.
- 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 (9 mg/ml) za injiciranje, ki je enak volumnu vial po rekonstituciji.
Common (may affect up to 1 in 10 people): infections of lungs, urinary infections, painful skin blisters (herpes), flu headache, dizziness high blood pressure cough abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting rash fatigue, weakness abnormal liver function tests
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužbe pljuč, okužbe sečil, boleči kožni mehurji (herpes), gripa, glavobol, omotica, visok krvni tlak, kašelj, bolečine v trebuhu, driska, slabost, želodčne težave, vnetje ustne sluznice, bruhanje, izpuščaj, utrujenost, oslabelost, nenormalni izvidi preiskav delovanja jeter.
The mean change was, 0.41 and 0.74 from year 1 to year 2 (n=290, 130), 0.37 and 0.68 from year 2 to year 3 (n=293, 130), 0.34 and 0.43 from year 3 to year 4 (n=290, 128) and the change was 0.26 and 0.29 (n=233, 114) from year 4 to year 5 for patients originally randomised to abatacept plus MTX and placebo plus MTX respectively.
Pri bolnikih, ki so bili prvotno randomizirani na abatacept in MTX so bile povprečne spremembe od 1. do 2. leta 0,41 (n=290), od 2. do 3. leta 0,37 (n=293), od 3. do 4. leta 0,34 (n=290), od 4. do 5. leta pa 0,26 (n=233).
Do not inject into an area where the skin is tender, bruised, red, scaly, or hard.
NE injicirajte v predele, kjer je koža občutljiva, podpluta, pordela, luskasta ali zatrdela.
DO NOT inject into an area where the skin is tender, bruised, red, scaly, or hard.
Ne injicirajte v predele, kjer je koža občutljiva, podpluta, pordela, luskasta ali zatrdela.
125 mg, solution for injection subcutaneous use
ORENCIA 125 mg injekcija abatacept subkutana uporaba
Sodium dihydrogen phosphate monohydrate Sodium chloride
6.1 Seznam pomožnih snovi maltoza natrijev dihidrogenfosfat monohidrat natrijev klorid
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.
Vendar pa so pri bolnikih, ki so se zdravili z zdravilom ORENCIA, poročali o omotici, kot o pogostem neželenem učinku, in o zmanjšani ostrini vida, kot o občasnem neželenem učinku.
NAME OF THE MEDICINAL PRODUCT ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Navodilo za uporabo ORENCIA 250 mg prašek za koncentrat za raztopino za infundiranje abatacept
Dispose of used ClickJect Pre-filled Pen into sharps disposal container right away after use.
Uporabljen ClickJect napolnjen injekcijski peresnik takoj zavrzite v posodo za odstranjevanje ostrih predmetov.
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.
Odziv ACR 20 je bil ugotovljen pri 72% bolnikov, odziv ACR 50 pri 58% bolnikov in odziv ACR 70 pri 44% bolnikov.
If your injection is administered by a caregiver, this person must also handle the syringe carefully to prevent accidental needle stick injury and possibly spreading infection.
Če vam zdravilo injicira oseba, ki skrbi za vas, mora z injekcijsko brizgo rokovati previdno.
In the cumulative period in clinical trials in 7,044 patients treated with abatacept during 20,510 patient-years, the incidence rate of serious infections was 2.4 per 100 patient-years, and the annualised incidence rate remained stable.
V kumulativnem obdobju se je v kliničnih preskušanjih 7.044 bolnikov z abataceptom intravensko zdravilo 20.510 bolnik-let.
Using your other hand, gently pinch the area of skin you cleaned.
Z drugo roko očiščen predel kože stisnite v kožno gubo.
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).
Za zdravljenje pJIA pri pediatričnih bolnikih, starih 6 let in starejših, je zdravilo ORENCIA na voljo v obliki praška za koncentrat za raztopino za infundiranje (glejte povzetek glavnih značilnosti zdravila ORENCIA prašek za koncentrat za raztopino za infundiranje).
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 125 mg abatacept in one mL.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 125 mg abatacepta v enem ml.
DON'T recap the needle.
Na iglo NE SMETE namestiti pokrovčka.
NAME OF THE MEDICINAL PRODUCT ORENCIA 87.5 mg solution for injection in pre-filled syringe abatacept
ORENCIA 87,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi abatacept
The primary outcome, incidence of AEs, SAEs, and discontinuations due to AEs during 6 months of treatment, was similar between those who were previous and current TNF-inhibitor users at enrollment, as was the frequency of serious infections.
Pri bolnikih, ki so se predhodno zdravili z zaviralcem TNF in bolnikih, ki so se z zaviralcem TNF zdravili neposredno pred vključitvijo v študijo, so bili primarni izid, pojavnost neželenih učinkov, resnih neželenih učinkov, delež prekinitev zdravljenja zaradi neželenih učinkov in pogostnost resnih okužb med 6-mesečnim zdravljenjem podobni.
ORENCIA solution for injection in pre-filled syringe for subcutaneous administration is available for paediatric patients 2 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA solution for injection in pre-filled syringe).
Za zdravljenje pJIA pri pediatričnih bolnikih, starih 2 leti in starejših, je zdravilo ORENCIA na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi za subkutano uporabo (glejte povzetek glavnih značilnosti zdravila ORENCIA raztopina za injiciranje v napolnjeni injekcijski brizgi).
In study PsA-II, the ACR 20 responses with abatacept 125 mg subcutaneous vs placebo in patients who were TNF inhibitor-naive were 44.0% vs 22.2%, respectively (21.9 [8.3, 35.6], estimate of difference [95% CI]), and in patients who were TNF inhibitor-experienced were 36.4% vs 22.3%, respectively (14.0 [3.3, 24.8], estimate of difference [95% CI]).
V študiji PsA-II je odziv ACR 20 pri uporabi abatacepta v odmerku 125 mg subkutano pri bolnikih, ki se predhodno niso zdravili z zaviralcem TNF, znašal 44,0%, pri uporabi placeba pa 22,2% (21,9 [8,3; 35,6], ocenjena razlika [95% interval zaupanja]).
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.
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.
Each mL contains 25 mg of abatacept, after reconstitution.
Po rekonstituciji vsebuje en ml 25 mg abatacepta.
During the extension period of the pJIA studies (20 months in the pJIA SC study and 5 years in the pJIA IV study), the safety profile in the pJIA patients aged 6 to 17 years was comparable to that seen in adult patients.
uporabe pri pJIA) je bil profil varnosti pri bolnikih s pJIA, starih od 6 do 17 let, primerljiv s tistim pri odraslih bolnikih.
For subcutaneous use.
Način uporabe za subkutano uporabo
Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using 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.
A randomised, single(investigator)-blinded, non-inferiority study was conducted to assess the safety and efficacy of weekly subcutaneous (SC) abatacept without an abatacept intravenous (IV) loading dose versus every-other-weekly subcutaneous adalimumab, both with background MTX, in patients with an inadequate response to methotrexate (study SC-II).
Pri bolnikih z nezadostnim odzivom na metotreksat je bila izvedena randomizirana, enojno slepa (raziskovalec) študija, ki je vrednotila neinferiornost varnosti in učinkovitosti tedenske subkutane (s.c.) uporabe abatacepta brez intravenskega (i.v.)
DO NOT use the Pen if it is dropped after the cap is removed.
NE uporabljajte injekcijskega peresnika, če vam po odstranitvi pokrovčka pade iz rok.
Read these instructions before you use the ClickJect Pre-filled Pen.
Pred začetkom uporabe ClickJect napolnjenega injekcijskega peresnika natančno preberite navodila.
Major Clinical Responsec
CRP remisijae
Do not use this medicine if you notice opaque particles, discolouration or other foreign particles present in the infusion solution.
Če v raztopini za infundiranje opazite motne delce, spremembo barve ali prisotnost tujih delcev, zdravila ne uporabljajte.
- Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same silicone-free disposable syringe provided with each vial.
- V infuzijsko vrečo ali steklenico iz vsake viale počasi dodajte rekonstituirano raztopino zdravila ORENCIA.
Check the Pen for damage.
Injekcijski peresnik preglejte glede morebitnih poškodb.
Paediatric population in polyarticular juvenile idiopathic arthritis
Pediatrična populacija s poliartikularnim juvenilnim idiopatskim artritisom
Injection Areas Self-Injection and Caregiver
Predeli za injiciranje: samoinjiciranje in injiciranje s pomočjo druge osebe
- After reconstitution the solution should be clear and colourless to pale yellow.
- Rekonstituirana raztopina mora biti bistra in brezbarvna do svetlorumena.
After reconstitution the solution should be clear and colourless to pale yellow.
Rekonstituirana raztopina mora biti bistra in brezbarvna do svetlorumena.
Don't pull back on the plunger at any time.
Bata nikoli NE VLECITE nazaj.
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.
Odziv ACR 20 je bil ugotovljen pri 85% bolnikov, odziv ACR 50 pri 74% bolnikov in odziv ACR 70 pri 54% bolnikov.
- You must not be treated with ORENCIA if you have severe infection.
- Če imate hudo okužbo, zdravila ORENCIA ne smete prejeti.
You must stop breast-feeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.
Med zdravljenjem z zdravilom ORENCIA in še do 14 tednov po uporabi zadnjega odmerka ne smete dojiti.
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).
Za zdravljenje pJIA pri pediatričnih bolnikih, starih 6 let in starejših, je zdravilo ORENCIA na voljo v obliki praška za koncentrat za raztopino za infundiranje za intravensko uporabo (glejte povzetek glavnih značilnosti zdravila ORENCIA prašek za koncentrat za raztopino za infundiranje).
Wash your hands well with soap and water to prepare for injection.
Pred začetkom injiciranja si temeljito umijte roke z milom in vodo.
During the extension period of the pJIA studies (20 months in the pJIA ongoing SC study and 5 years in the pJIA IV study), the safety profile in the pJIA patients aged 6 to 17 years was comparable to that seen in adult patients.
Med podaljšanim obdobjem študij uporabe zdravila pri pJIA (20 mesecev v študiji s.c. uporabe pri pJIA, ki še poteka, in 5 let v študiji i.v.
Mean Improvement from Baseline
Povprečno izboljšanje od izhodišča
Healthcare professionals will monitor you while you receive your ORENCIA infusion.
Med infundiranjem zdravila ORENCIA boste pod zdravniškim nadzorom.
Alcohol swab
alkoholni zloženec samolepilni obliž
Administration of ORENCIA should be discontinued if a patient develops a serious infection.
Če se pri bolniku pojavi huda okužba, je treba dajanje zdravila ORENCIA prekiniti.
Very Common
Po redčenju
Use the silicone-free disposable syringe included in the package for reconstitution.
Za rekonstitucijo uporabite injekcijsko brizgo brez silikona za enkratno uporabo, ki je priložena ovojnini.
Multipack: 12 ClickJect pre-filled pens (3 packs of 4) 5.
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjenem injekcijskem peresniku (ClickJect) Skupno pakiranje: 12 ClickJect napolnjenih injekcijskih peresnikov (3 pakiranja po 4) 5.
However, the number of patients that developed antibodies was too limited to make a definitive assessment.
Med razvojem protiteles in kliničnim odzivom ali neželenimi učinki na splošno ni očitne povezave, vendar pa je število ovrednotenih bolnikov s protitelesi za navedbo definitivne ocene premajhno.
NAME OF THE MEDICINAL PRODUCT ORENCIA 125 mg solution for injection in pre-filled pen 2.
ORENCIA 125 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 2.
Uncommon Chronic obstructive pulmonary disease exacerbated, bronchospasm, wheezing, dyspnea, throat tightness
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti kašelj občasni poslabšanje kronične obstrukcijske pljučne bolezni, bronhospazem, piskanje, dispneja, stiskanje v žrelu
Read the package leaflet for the shelf-life of the reconstituted product.
Za rok uporabnosti zdravila po rekonstituciji glejte priloženo navodilo za uporabo.
Infusion-related reactions
Neželeni učinki, povezani z injiciranjem
Poloxamer 188
6.1 Seznam pomožnih snovi saharoza poloksamer 188
Weekly Dose of ORENCIA Body Weight of Patient
Tedenski odmerek zdravila ORENCIA Telesna masa bolnika Odmerek 10 kg do manj kot 25 kg
Pre-filled syringe with UltraSafe Passive Needle guard
Razširjeno držalo za prsta kosem vate ali gaza napolnjena injekcijska brizga z UltraSafe Passive varovalom za iglo posoda za odstranjevanje ostrih predmetov
NAME OF THE MEDICINAL PRODUCT ORENCIA 50 mg solution for injection in pre-filled syringe abatacept
ORENCIA 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi abatacept
Abatacept was shown to cross the placenta in rats and rabbits.
Pri podganah in kuncih je bilo dokazano, da abatacept prehaja preko placente.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 250 mg abatacept.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 250 mg abatacepta.
Let your skin dry before injecting.
Pred injiciranjem zdravila počakajte, da se koža posuši.
Day 15 Month 3 64%††
3. mesec 19%† 6. mesec 32%† 12. mesec 43%‡
Talk to your doctor if you have any questions about giving yourself an injection.
Če imate o injiciranju zdravila kakršno koli vprašanje, se posvetujte z zdravnikom.
Multipack: 12 pre-filled syringes with needle guard (3 packs of 4) 5.
FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjeni injekcijski brizgi Skupno pakiranje: 12 napolnjenih injekcijskih brizg z varovalom za iglo (3 pakiranja po 4) 5.
NAME OF THE MEDICINAL PRODUCT ORENCIA 125 mg solution for injection in pre-filled syringe abatacept
Navodilo za uporabo ORENCIA 125 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku abatacept
The Pen automatically delivers the medicine.
Bolniki so še naprej prejemali stabilni odmerek metotreksata.
In study SC-I, abatacept administered subcutaneously (SC) was non-inferior relative to intravenous (IV) infusions of abatacept with respect to ACR 20 responses up to 6 months of treatment.
V študiji SC-I subkutana (s.c.) uporaba abatacepta ni bila inferiorna v primerjavi z intravenskim (i.v.)
Don't touch the needle or let it touch any surfaces.
Igle se ne smete dotakniti.
Typical estimates for distribution volume and elimination half-life were 0.12 L/kg and 11.4 days, respectively, for a child weighing 40 kg. As a result of the higher body-weight normalised clearance and volume of distribution in pJIA patients, the predicted and observed systemic exposures of abatacept were lower than that observed in adults, such that the observed mean (range) peak and trough concentrations were 204 (66 to 595) mcg/mL and 10.6 (0.15 to 44.2) mcg/mL, respectively, in patients weighing less than 40 kg, and 229 (58 to 700) mcg/mL and 13.1 (0.34 to 44.6) mcg/mL, respectively, in patients weighing 40 kg or greater.
Pri bolnikih s telesno maso 40 kg ali več je povprečna vrednost opažene najvišje koncentracije znašala 229 µg/ml (razpon 58 do 700 µg/ml), povprečna vrednost opažene najnižje koncentracije pa 13,1 µg/ml (razpon 0,34 do 44,6 µg/ml).
† p < 0.01, abatacept plus MTX vs. MTX plus placebo ‡ p < 0.001, abatacept plus MTX vs. MTX plus placebo †† p < 0.05, abatacept plus MTX vs. MTX plus placebo a Fixed dose approximating 10 mg/kg (see section 4.2).
† p < 0,01, abatacept in MTX v primerjavi z MTX in placebom.
Do not use if opaque particles, discolouration, or other foreign particles are present.
drugačno obarvanje ali tujke, raztopine ne uporabljajte.
Press & Hold
Pritisnite in zadržite
If you have questions about this product, please read the Package Leaflet.
Če imate o injekcijskem peresniku ali zdravilu kakršno koli vprašanje, preberite navodilo za uporabo.
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. In study SC-I, improvement from baseline as measured by HAQ-DI at 6 months and over time was similar between subcutaneous and intravenous administration.
V študiji SC-I je bilo izboljšanje od izhodišča, ovrednoteno s HAQ-DI po 6 mesecih in kasneje, pri subkutani in intravenski uporabi podobno.
Rare
Redčenje
Powder for concentrate for solution for infusion.
FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje
One serious adverse reaction of infection (limb abscess) was reported in the 2 to 5 year age cohort during the 20-month extension period of the pJIA SC study.
Med 20-mesečnim podaljšanim obdobjem študije s.c. uporabe pri pJIA so v kohorti bolnikov, starih od 2 do 5 let, poročali o enem resnem neželenem učinku v obliki okužbe (absces na okončini).
How to store ORENCIA
Shranjevanje zdravila ORENCIA
Bristol-Myers Squibb S.r.l Tel: + 39 06 50 39 61
Bristol-Myers Squibb S.A. Tel: + 34 91 456 53 00
Subcutaneous use.
uporabo abatacepta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 4 PRE-FILLED SYRINGES WITH NEEDLE GUARD 1.
ŠKATLA ZA PAKIRANJA S 4 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI Z VAROVALOM ZA IGLO
Don't
Nikoli ne smete
The transparent tip locks over the needle once the injection is complete and the Pen is removed from the skin.
Po končanem injiciranju in odstranitvi injekcijskega peresnika iz kože prozorna konica obda in zavaruje iglo.
125 mg/mL Pre-filled Syringe
125 mg/ml napolnjena injekcijska brizga bel bat svetlomoder bat oranžen bat
Do not wait until your next planned visit.
Ne čakajte do naslednjega načrtovanega obiska.
· Risk Management Plan (RMP)
· Načrt za obvladovanje tveganja (RMP)
** The interim analysis for OS was conducted when 331 events were observed.
** Vmesna analiza celokupnega preživetja je bila izvedena, ko je bilo zabeleženih 331 dogodkov.
Repeat LVEF assessment within 3 weeks.
Ponovite meritev LVEF v 3 tednih.