natgillin/translations-raw huggingface dataset:
• Do not remove the cap from the pre-filled pen until immediately before the injection.
• Pokrovček smete z napolnjenega injekcijskega peresnika sneti šele tik pred injiciranjem.
In the Phase II and III UC studies through week 54, antibodies to golimumab were detected by the EIA method in 3% (26/946) of golimumab treated patients.
V študijah faze II in III so pri bolnikih z ulceroznim kolitisom v času do 54. tedna z metodo EIA ugotovili protitelesa proti golimumabu pri 3 % (26/946) bolnikov, zdravljenih z golimumabom.
Based on the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Na osnovi sedanjega znanja ni mogoče izključiti morebitnega tveganja za nastanek limfomov, levkemije ali drugih malignomov pri bolnikih, zdravljenih z antagonistom TNF, zato je pri premisleku o uvedbi zdravljenja z zaviralci TNF pri bolnikih, ki so imeli v preteklosti malignom, oziroma pri premisleku glede nadaljevanja zdravljenja pri tistih bolnikih, ki se jim pojavi malignom, potrebna previdnost.
In nr-Axial SpA, antibodies to golimumab were detected in 7% (14/193) of golimumab treated patients through week 52.
Pri nr-aksialnem SpA so protitelesa proti golimumabu do 52. tedna odkrili pri 7 % (14/193) bolnikov, zdravljenih z golimumabom.
Each pre-filled pen can deliver 0.1 mL to 0.45 mL in increments of 0.05 mL.
En napolnjen injekcijski peresnik lahko injicira od 0,1 ml do 0,45 ml v korakih po 0,05 ml.
Symptoms of blood disease can include a fever that does not go away, bruising or bleeding very easily or looking very pale.
Simptomi bolezni krvi lahko vključujejo stalno zvišano telesno temperaturo, zelo hiter nastanek modric ali krvavitev ali zelo bled videz.
In GO-FORWARD, among 89 subjects randomised to Simponi 50 mg + MTX, 48 were still on this treatment at week 104.
V študiji GO-FORWARD med 89 preiskovanci, ki so bili naključno razvrščeni v skupino, ki je prejemala 50 mg zdravila Simponi in MTX, jih je v 104. tednu 48 še vedno prejemalo to zdravljenje.
• Set prescribed dose
• nastaviti predpisani odmerek,
Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman.
V serumu dojenčka matere, ki je bila v času nosečnosti zdravljena z monoklonskimi protitelesi, ki zavirajo TNF, so še 6 mesecev zaznavali navzočnost teh protiteles.
Common: Dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders (such as gastritis and colitis), stomatitis Uncommon: Constipation, gastro-oesophageal reflux disease
Pogosti: dispepsija, bolečine v prebavilih in trebuhu, navzea, vnetne bolezni prebavil (npr. gastritis in kolitis), stomatitis Občasni: zaprtost, gastro-ezofagealna refluksna bolezen
Throw the pre-filled syringe away (see figure 10)
Napolnjeno injekcijsko brizgo zavrzite (glejte sliko 10)
In general, no clinically meaningful differences in measures of efficacy were observed between the Simponi 50 mg and 100 mg dosing regimens through week 24.
V 24. tednu na splošno niso opazili nikakršnih klinično pomembnih razlik v merilih učinkovitosti med shemama odmerjanja zdravila Simponi s 50 mg ali 100 mg.
Do not use the pre-filled syringe if it is dropped without the needle cover in place.
Napolnjene injekcijske brizge ne smete uporabiti, če vam je padla brez nameščenega pokrovčka.
Key ACR results for the Simponi 50 mg dose at weeks 14, 24 and 52 for GO-FORWARD, GO-AFTER and GO-BEFORE are shown in Table 2 and are described below.
Bistveni rezultati za ACR za zdravilo Simponi v odmerku 50 mg v 14., 24. in 52. tednu za GO-FORWARD, GO-AFTER in GO-BEFORE so prikazani v Preglednici 2 in opisani v nadaljevanju.
Symptoms of TB include persistent cough, weight loss, tiredness, fever or night sweats.
Simptomi TB vključujejo dolgotrajen kašelj, izgubo telesne mase, utrujenost, zvišano telesno temperaturo ali nočno potenje.
A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF-blockers cannot be excluded.
Pri bolnikih, zdravljenih z zaviralci TNF, ni mogoče izključiti tveganja za nastanek hepatospleničnega T-celičnega limfoma.
Symptoms of an infection can include fever, tiredness, (persistent) cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.
Simptomi okužbe lahko vključujejo zvišano telesno temperaturo, utrujenost, (dolgotrajen) kašelj, kratko sapo, gripi podobne simptome, izgubo telesne mase, nočno potenje, drisko, rane, težave z zobmi in pekoč občutek pri uriniranju.
• Do not use the pre-filled pen if the liquid is the wrong colour, cloudy, or contains larger particles.
• Napolnjenega injekcijskega peresnika ne smete uporabiti, če je tekočina napačne barve, motna ali vsebuje večje delce.
In the controlled period of the UC pivotal trials of golimumab induction, mild ALT elevations (> 1 and < 3 x ULN) occurred in similar proportions of golimumab-treated and control patients (8.0% to 6.9%, respectively).
V kontroliranem obdobju ključnih preskušanj indukcije z golimumabom pri bolnikih z UK se je blago zvišanje ALT (> 1 in < 3 x(ZMN)) pojavilo pri podobnem deležu bolnikov, zdravljenih z golimumabom, in bolnikov v kontrolni skupini (8,0 % pri prvih in 6,9 % pri drugih).
Let the pre-filled pen sit at room temperature for at least 30 minutes out of reach of children.
Napolnjeni injekcijski peresnik pustite vsaj 30 minut na sobni temperaturi, nedosegljiv otrokom.
No animal fertility studies have been conducted with golimumab.
Študije vpliva golimumaba na plodnost pri živalih niso bile opravljene.
In the controlled portions of the Simponi Phase IIb and Phase III clinical trials in RA, PsA, AS, and ulcerative colitis (UC), the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
V nadzorovanem delu kliničnih preskušanj faze IIb in faze III z zdravilom Simponi pri bolnikih z RA, PsA, AS in ulceroznim kolitisom (UK) je bila incidenca nelimfomskih malignomov (z izjemo nemelanomskega kožnega raka) pri skupini, ki je prejemala golimumab, podobna kot pri kontrolnih skupinah.
• You may get infections more easily while using Simponi.
• Med uporabo zdravila Simponi ste bolj dovzetniza okužbe.
The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein.
Raztopina je bistra do rahlo opalescentna ter brezbarvna do svetlo rumena in lahko vsebuje nekaj majhnih prosojnih ali belih delcev beljakovin.
Among patients remaining in the study and treated with Simponi, the proportion of patients with an ASAS 20 and ASAS 40 response were similar from week 24 through week 256.
Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podoben delež bolnikov z odzivom ASAS 20 in ASAS 40 opažali od 24. do 256. tedna.
Symptoms can include a persistent cough, being short of breath, chest pain, fever, swelling of your lymph nodes, weight loss, skin rashes, and blurred vision.
Simptomi lahko vključujejo dolgotrajen kašelj, kratko sapo, bolečine v prsih, zvišano telesno temperaturo, otekanje bezgavk, izgubo telesne mase, kožne izpuščaje in zamegljen vid.
Table 5 Radiographic mean (SD) changes from baseline in total vdH-S score at week 52 in the overall population of GO-BEFORE Placebo + MTX Simponi 50 mg + MTX
Preglednica 5 Radiografska srednja vrednost (SD) sprememb glede na začetne vrednosti skupnega rezultata vdH-S v 52. tednu pri celotni skupini bolnikov, vključenih v študijo GO-BEFORE Placebo + MTX
Nervous system disease
Bolezni živčevja
Take the pre-filled pen out of the carton.
Napolnjeni injekcijski peresnik vzemite iz škatle.
Carriers of HBV who require treatment with golimumab should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Prenašalce virusa HBV, ki potrebujejo zdravljenje z golimumabom, je treba ves čas zdravljenja in še nekaj mesecev po prenehanju zdravljenja skrbno spremljajti glede znakov in simptomov aktivne okužbe s HBV. Na voljo ni dovolj podatkov o zdravljenju bolnikov, ki so prenašalci HBV, s protivirusno terapijo ob zdravljenju z antagonisti TNF za preprečevanje reaktivacije HBV.
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including golimumab.
Kongestivno srčno popuščanje (congestive heart failure - CHF) Pri uporabi zaviralcev TNF, vključno z golimumabom, so poročali o primerih poslabšanja kongestivnega srčnega popuščanja (CHF) in primerih novonastalega CHF.
In the Phase II and III UC studies through week 54, antibodies to golimumab were detected in 3% (26/946) of golimumab treated patients.
V študijah faze II in III so pri bolnikih z ulceroznim kolitisom v času do 54. tedna ugotovili protitelesa proti golimumabu pri 3 % (26/946) bolnikov, zdravljenih z golimumabom.
Therapeutic infectious agents
Povzročitelji okužb v terapevtske namene
Check expiry date (see figure 2)
Preverite rok uporabnosti zdravila (glejte sliko 2)
Make sure you dispose of the bin as instructed by your doctor or nurse.
S to posodo morate ravnati v skladu z navodili zdravnika ali medicinske sestre.
Simponi or placebo were administered subcutaneously every 4 weeks.
Zdravilo Simponi ali placebo so jim dajali subkutano na vsake 4 tedne.
Key ACR results for the Simponi 50 mg dose at weeks 14, 24 and 52 for GO-FORWARD, GO-AFTER and GO-BEFORE are shown in Table 4 and are described below.
Bistveni rezultati za ACR za zdravilo Simponi v odmerku 50 mg v 14., 24. in 52. tednu za GO-FORWARD, GO-AFTER in GO-BEFORE so prikazani v preglednici 4 in opisani v nadaljevanju.
How Simponi is given
Kako se daje zdravilo Simponi
In the controlled and uncontrolled periods of RA, PsA and AS pivotal trials, with a median follow-up of 5 years, the incidence of ALT elevations ≥ 5 x ULN was similar in both golimumab-treated and control patients.
V kontroliranih in nekontroliranih obdobjih ključnih preskušanj pri bolnikih z RA in PsA in AS z medianim trajanjem spremljanja bolnikov 5 let je bila incidenca zvišanja vrednosti ALT ≥ 5 x ZMN pri bolnikih, zdravljenih z golimumabom, podobna kot pri tistih iz kontrolne skupine.
Among those, 40, 33 and 24 patients had ACR 20/50/70 response, respectively at week 104.
Od tega je imelo v 104. tednu 40 bolnikov odziv ACR 20, 33 jih je imelo odziv ACR 50, 24 pa odziv ACR 70.
In the controlled and uncontrolled periods of pivotal trials with a median follow-up of up to 3 years, non-melanoma skin cancer was diagnosed in 5 placebo-treated, 10 golimumab 50 mg-treated and 31 golimumab 100 mg-treated subjects with an incidence (95% CI) per 100 subject-years of follow-up of 0.36 (0.26, 0.49) for combined golimumab and 0.87 (0.28, 2.04) for placebo.
V kontroliranih in nekontroliranih obdobjih ključnih preskušanj z medianim trajanjem spremljanja bolnikov do 3 let so diagnozo nemelanomskega kožnega raka postavili pri 5 preiskovancih, ki so prejemali placebo, 10 preiskovancih, zdravljenih s 50 mg golimumaba, in 31 preiskovancih, zdravljenih s 100 mg golimumaba z naslednjima incidencama (95 % IZ) na 100 preiskovanec-let spremljanja: 0,36 (0,26, 0,49) skupno za golimumab in 0,87 (0,28, 2,04) za placebo.
Patients were randomised to receive placebo + MTX, Simponi 50 mg + MTX, Simponi 100 mg + MTX or Simponi 100 mg + placebo.
Te bolnike so naključno razvrstili bodisi v skupino, ki bo prejemala placebo in MTX, zdravilo Simponi 50 mg in MTX, zdravilo Simponi 100 mg in MTX, ali pa zdravilo Simponi 100 mg in placebo.
Select from the following areas for your injection:
Za injiciranje izberite eno od naslednjih mest:
• The recommended dose is 50 mg (the content of 1 pre-filled syringe) given once a month, on the same date each month.
• Priporočeni odmerek je 50 mg (vsebina 1 napolnjene injekcijske brizge) enkrat na mesec, vsak mesec na isti datum.
Patients should be tested for HBV infection before initiating treatment with golimumab.
Pred začetkom zdravljenja z golimumabom je treba bolnike testirati na okužbo z virusom hepatitisa B (HBV).
Adult rheumatoid arthritis
Revmatoidni artritis pri odraslih
• Chest discomfort
• občutek omotičnosti,
• cancer of the lymph nodes (lymphoma) (rare).
• rak limfnih žlez (limfom) (redko).
Table 3 Radiographic mean (SD) changes from baseline in total vdH-S score at week 52 in the overall population of GO-BEFORE Placebo + MTX Simponi 50 mg + MTX
Preglednica 3 Radiografska srednja vrednost (SD) sprememb glede na začetne vrednosti skupnega rezultata vdH-S v 52. tednu pri celotni skupini bolnikov, vključenih v študijo GO-BEFORE Placebo + MTX
You will not be able to press in the button unless the pre-filled pen is pushed firmly against your skin and the Safety Sleeve slides into the Clear Cover.
Če napolnjeni injekcijski peresnik ne bo čvrsto pritisnjen ob kožo in če varnostni ovoj ne bo zdrsnil v prozorni ovoj, na gumb ne boste mogli pritisniti.
o If your dose is 200 mg, you will get four 50 mg pre-filled syringes and you will need to give yourself four injections.
o Če je vaš odmerek 200 mg, boste dobili štiri 50 mg napolnjene injekcijske brizge in si boste morali dati štiri injekcije.
In the controlled periods of the pivotal UC trials, of golimumab induction, ALT elevations ≥ 5 x ULN occurred in similar proportions of golimumab-treated patients compared to placebo-treated patients (0.3% to 1.0%, respectively).
V kontroliranih obdobjih ključnih preskušanj indukcije z golimumabom pri UK so se zvišanja ALT na ≥ 5 x ZMN pojavila pri podobnem deležu bolnikov, zdravljenih z golimumabom, in bolnikov, ki so prejemali placebo (0,3 % pri prvih in 1,0 % pri drugih).
The 154 children who achieved an American College of Rheumatology (ACR) Ped 30 response at week 16 entered Part 2 of the study, the randomised withdrawal phase, and received Simponi 30 mg/m2 (maximum
154 otrok, ki je v 16. tednu doseglo odziv po kriterijih Ameriškega združenja za revmatologijo (American College of Rheumatology - ACR) Ped 30, so vključili v drugi del študije, in sicer v randomizirano fazo odtegnitve zdravila, v kateri so vsake 4 tedne prejeli 30 mg/m2 (največ 50 mg) zdravila Simponi in MTX ali placebo in MTX.
Among those, 85, 66 and 53 patients had ACR 20/50/70 response, respectively, at week 104.
Med njimi je imelo v 104. tednu 85 bolnikov odziv ACR 20, 66 bolnikov odziv ACR 50 in 53 bolnikov odziv ACR 70.
Among patients remaining in the study and treated with Simponi, similar rates of ACR 20/50/70 response were observed from week 104 through week 256.
Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobne stopnje odziva ACR (20/50/70) opažali od 104. do 256. tedna.
• Do not shake the pre-filled syringe at any time.
• Napolnjene injekcijske brizge ne smete nikoli stresati.
Please also read the ‘Package Leaflet: Information for the user' carefully before starting your injection.
Pred začetkom injiciranja zdravila skrbno preberite tudi navodilo za uporabo.
The 45 mg/0.45 mL pre-filled pen is for paediatric patients.
Napolnjeni injekcijski peresnik v odmerku 45 mg/0,45 ml je namenjen pediatričnim bolnikom.
In general, no clinically meaningful differences in measures of efficacy were observed between the Simponi 50 mg and 100 mg dosing regimens through week 104.
V 104. tednu na splošno niso opazili nikakršnih klinično pomembnih razlik v merilih učinkovitosti med shemama odmerjanja zdravila Simponi s 50 mg ali 100 mg.
Among patients remaining in the study and treated with Simponi, radiographic effects were similar from week 104 through week 256.
Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobne radiografske učinke opažali od 104. do 256. tedna.
Discontinuation of golimumab should be considered if these disorders develop (see section 4.8).
Če se te motnje pojavijo, je treba premisliti o prekinitvi zdravljenja z golimumabom (glejte poglavje 4.8).
Responses were observed at the first assessment (week 4) after the initial Simponi administration.
Odzive so opazili že ob prvi oceni (v 4. tednu) po prvi uporabi zdravila Simponi.
Do not touch the plunger while you do this.
Pri tem se ne smete dotakniti bata.
Inject Simponi using the pre-filled pen
Zdravilo Simponi injicirajte z napolnjenim injekcijskim peresnikom
Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 and HAQ DI responses were maintained through week 104.
Pri bolnikih, ki so se ves čas zdravili z zdravilom Simponi, odkar so bili v to skupino naključno razvrščeni na začetku študije, so se vrednosti odzivov DAS28 in HAQ DI ohranjale vse do 104. tedna.
The long half-life should be taken into consideration if a surgical procedure is planned.
Če je pri bolniku načrtovan kirurški poseg, je treba upoštevati dolgo razpolovno dobo zdravila.
• 1 Adhesive bandage
• 1 obliž
Solution for injection in pre-filled syringe Multipack: 3 (3 packs of 1) pre-filled syringes
raztopina za injiciranje v napolnjenem injekcijskem peresniku (SmartJect) Večkratno pakiranje: 3 napolnjeni injekcijski peresniki (3 enojna pakiranja)
GO-AFTER evaluated 445 patients who were previously treated with one or more of the anti-TNF agents adalimumab, etanercept, or infliximab.
V študiji GO-AFTER pa so ovrednotili 445 bolnikov, ki so se pred tem zdravili z enim ali več zaviralcev TNF, t.j.
Do not use the pre-filled syringe if the expiration date has passed.
Napolnjene injekcijske brizge ne smete uporabljati, če je pretečen rok uporabnosti zdravila.
Adult psoriatic arthritis
Psoriatični artritis pri odraslih
b < 1.3 BASDAI 50 Inhibition of inflammation in sacroiliac (SI) joints as measured by MRI Placebo Simponi 50 mg Placebo Simponi 50 mg
Zavrto vnetje v sakroiliakalnih (SI) sklepih, merjeno z MRI Placebo Simponi 50 mg Placebo Simponi 50 mg n
General disorders and administration site conditions Common: Pyrexia, asthenia, injection site reaction (such as injection site erythema, urticaria, induration, pain, bruising, pruritus, irritation and paraesthesia), chest discomfort Rare: Impaired healing Injury, poisoning and procedural complications
Pogosti: zvišana telesna temperatura, astenija, reakcija na mestu injiciranja (npr. eritem na mestu injiciranja, urtikarija, zatrdlina, bolečina, podplutba, pruritus, draženje in parestezija), tiščanje v prsnem košu Redki: slabše celjenje Poškodbe in zastrupitve in zapleti pri posegih
There were no patients age 45 and over in the non-radiographic axial spondyloarthritis (nr-Axial SpA) study.
V študiji neradiografskega aksialnega spondiloartritisa (nr-aksialnega SpA) ni bilo bolnikov, starih 45 let ali več.
a cotton ball or gauze and a sharps container.
kosmom vate ali zložencem iz gaze ter posodo za odlaganje ostrih odpadkov.
Among patients who remained on the Simponi treatment to which they were randomised at study start, improvement of the SF-36 physical component was maintained through week 104.
Med bolniki, na začetku študije naključno razporejenimi v skupino, ki je prejemala zdravilo Simponi, se je pri tistih, ki so se še naprej zdravili z zdravilom Simponi, izboljšanje rezultata vprašalnika SF-36 glede telesnega zdravja ohranilo vse do 104. tedna.
In the controlled and uncontrolled portions of the pivotal trials with a median follow-up of up to 3 years, there was a greater incidence of serious infections, including opportunistic infections and TB in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg.
V kontroliranih in nekontroliranih delih teh preskušanj z medianim trajanjem spremljanja do 3 let, so opazili večjo incidenco limfoma med bolniki, ki so prejemali golimumab v odmerku 100 mg, kot med bolniki, ki so prejemali golimumab v odmerku 50 mg.
Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
Pri otrocih, pri katerih v tem času ni dokazov o terapevtski koristi zdravljenja, je treba premisliti o smiselnosti nadaljevanja zdravljenja.
Simponi has minor influence on the ability to ride bicycles, drive and use machines.
Zdravilo Simponi ima majhen vpliv na sposobnost vožnje kolesa, upravljanja vozil in strojev.
Among patients remaining in the study and treated with Simponi, improvement in HAQ DI was similar from week 104 through week 256.
Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobno izboljšanje rezultata HAQ DI opažali od 104. do 256. tedna.
Across the Phase III RA, PsA and AS studies through week 52, antibodies to golimumab were detected by the enzyme immunoassay (EIA) method in 5% (105/2062) of golimumab treated patients and, where tested, nearly all antibodies were neutralising in vitro.
V študijah faze III so pri bolnikih z revmatoidnim artritisom, psoriatičnim artritisom ali ankilozirajočim spondilitisom v času do 52. tedna z encimsko-imunsko metodo (EIA - enzyme immunoassay) ugotovili protitelesa proti golimumabu pri 5 % (105/2062) bolnikov, zdravljenih z golimumabom.
• Do not use the pre-filled pen if the expiration date has passed.
• Napolnjenega injekcijskega peresnika ne smete uporabljati, če je pretečen rok uporabnosti zdravila.
Part 1 of the study consisted of a 16-week open-label phase in which 173 enrolled children received Simponi 30 mg/m
Prvi del študije je obsegal 16-tedensko odprto fazo, v kateri je 173 vključenih otrok prejemalo 30 mg/m2 (največ 50 mg) zdravila Simponi subkutano vsake 4 tedne v kombinaciji z MTX.
Simponi 50 mg treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at week 24 as measured by change from baseline in total modified vdH-S Score (mean ± SD score was 0.27 ± 1.3 in the placebo group compared with -0.16 ± 1.3 in the Simponi group; p = 0.011).
To so merili na podlagi sprememb v skupni modificirani oceni vdH-S glede na začetne vrednosti (v skupini za prejemanje placeba je srednja vrednost ocene ± SD znašala 0,27 ± 1,3, v primerjavi z -0,16 ± 1,3 v skupini za prejemanje zdravila Simponi; p = 0,011).
In nr-Axial SpA, antibodies to golimumab were detected in 7% (14/193) of golimumab treated patients through week 52 by the EIA method.
Pri nr-aksialnem SpA so protitelesa proti golimumabu do 52. tedna z metodo EIA odkrili pri 7 % (14/193) bolnikov, zdravljenih z golimumabom.
• Please read the enclosed package leaflet
• Preberite priloženo navodilo za uporabo.
One 0.45 mL pre-filled pen contains 45 mg golimumab 1 mL contains 100 mg golimumab.
En napolnjen injekcijski peresnik vsebuje 45 mg golimumaba* v 0,45 ml. 1 ml raztopina vsebuje 100 mg golimumaba.
Among patients remaining in the study and treated with Simponi, improvement of the SF-36 physical component was similar from week 104 through week 256.
Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobno izboljšanje rezultata vprašalnika SF-36 glede telesnega zdravja opažali od 104. do 256. tedna.
Do not attempt to recap the needle.
Na iglo ne smete več namestiti pokrovčka.
Simponi 45 mg/0.45 mL solution for injection
Simponi 45 mg/0,45 ml raztopina za injiciranje
Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab.
Pri bolnikih, ki so prejemali golimumab, so poročali o bakterijskih okužbah (vključno s sepso in pljučnico), mikobakterijskih okužbah (vključno s TB), invazivnih glivnih okužbah in oportunističnih okužbah, vključno s smrtnimi primeri.
The pen should not be shaken.
Peresnika se ne sme stresati.
• Rheumatoid arthritis
• revmatoidnega artritisa,
• Sinus infection
• okužba sinusov,
PRE-FILLED PEN FOR PAEDIATRIC USE CARTON
ŠKATLA ZA NAPOLNJENI INJEKCIJSKI PERESNIK ZA PEDIATRIČNO UPORABO
Do not lift the pre-filled pen away from your skin.
Napolnjenega injekcijskega peresnika še ne smete dvigniti stran od kože.
Please contact your doctor or pharmacist.
se posvetujte z zdravnikom ali farmacevtom.
• Psoriatic arthritis
• psoriatičnega artritisa,