natgillin/translations-raw huggingface dataset:
The incidence of localised injection site reactions (e.g. injection site erythema, pain, pruritus and swelling) was 17.6 per 100 patient-years in the Remsima subcutaneous group (from Week 6) and 21.4 per 100 patient-years in those who switched to Remsima subcutaneous administration (from Week 30). 
V skupini, ki je prejemala zdravilo Remsima v subkutani obliki (od 6. tedna naprej), je bila pojavnost lokalnih reakcij na mestu injiciranja (npr. eritem na mestu injiciranja, bolečina, pruritus in oteklina) 17,6 na 100 bolnikov-let in 21,4 na 100 bolnikov-let v skupini, ki je prešla na zdravilo
Do not rub the injection site. 
Mesta injiciranja ne smete drgniti.
• Alcohol swab 
• alkoholni zloženec
• Remsima 120 mg solution for injection is administered by injection under the skin (subcutaneous use) only. 
• Zdravilo Remsima 120 mg raztopina za injiciranje se daje izključno z injiciranjem pod kožo
Data to support dose titration in rheumatoid arthritis come from ATTRACT, ASPIRE and the START study. 
Podatki, ki govorijo v prid titraciji odmerka pri revmatoidnem artritisu, so bili zbrani v študijah
Note: Rotate the injection site each time you give an injection. 
Opomba: Za vsako injiciranje izberite drugo mesto injiciranja.
In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit. 
Sočasna uporaba zaviralcev TNF-alfa in abatacepta V kliničnih študijah je bila sočasna uporaba zaviralcev TNF in abatacepta povezana z večjim tveganjem za okužbe (vključno z resnimi okužbami) kot pa uporaba samih zaviralcev TNF, čeprav ni prišlo do povečanja kliničnega učinka.
Week 50 a p <0.001, for each infliximab treatment group vs. control. 
50. teden a p < 0,001 za vsako terapevtsko skupino, ki je prejemala infliksimab, v primerjavi s kontrolno skupino b n = 292
• Side effect due to an injection 
• neželeni učinek zaradi injekcije • bolečine.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Remsima. 
Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom ali farmacevtom, preden boste prejeli zdravilo Remsima.
Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remsima. 
Zdravniku povejte takoj, če se pojavijo simptomi nevrološke bolezni med zdravljenjem z zdravilom Remsima.
Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remsima. 
Zdravniku povejte takoj, če se med zdravljenjem z zdravilom Remsima pojavijo novi znaki srčnega popuščanja ali se obstoječi znaki poslabšajo.
• Tell your doctor if you have an infection even if it is a very minor one. 
Zdravniku povejte, če imate kakršno koli, tudi najmanjšo okužbo.
After reconstitution one ml contains 10 mg of infliximab. 
Po rekonstituciji en ml vsebuje ml 10 mg infliksimaba.
Remsima 100 mg powder for concentrate for solution for infusion 
Remsima 100 mg prašek za koncentrat za raztopino za infundiranje
Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled syringe. 
Zdravilo Remsima je bistra do opalescentna in brezbarvna do bledo rjava raztopina, ki je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo.
Tachycardia, palpitation 
tahikardija, palpitacije občasni:
Note: Keep the pen and sharps disposal container out of the sight and reach of children. 
Opomba: Injekcijsko brizgo in vsebnik za ostre odpadke shranite nedosegljiva otrokom.
In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab. 
psoriatičnim artritisom in Crohnovo boleznijo lahko zmanjša tvorbo protiteles proti infliksimabu in poveča koncentracijo infliksimaba v plazmi.
The primary endpoints were the reduction of signs and symptoms as assessed by the ACR criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function. 
ACR) (ACR 20 za ATTRACT, mejna vrednost ACR-N za ASPIRE), preprečevanje strukturne okvare sklepov in izboljšanje njihove funkcije.
Remsima should be visually inspected for particulate matter or discolouration prior to administration. 
Zdravilo Remsima morate pred uporabo vizualno pregledati, da ugotovite, ali vsebuje delce in ali je obarvano.
PGA of cleared (0) or minimal (1) 
≥ 50 % izboljšanje PGA brez plakov (0) ali minimalni (1)
Remove the cap (see Figure D). 
Snemite pokrovček (glejte sliko D).
EU/1/13/853/012 1 pre-filled pen EU/1/13/853/013 2 pre-filled pens EU/1/13/853/014 4 pre-filled pens 
EU/1/13/853/012 1 napolnjen injekcijski peresnik EU/1/13/853/013 2 napolnjena injekcijska peresnika EU/1/13/853/014 4 napolnjeni injekcijski peresniki
Do not blow on or touch the injection site again before giving the injection. 
Pred injiciranjem na mesto injiciranja ne smete pihati ali se ga dotikati.
Each pack contains 1 pre-filled syringe with 2 alcohol pads, 2 pre-filled syringes with 2 alcohol pads or 4 pre-filled syringes with 4 alcohol pads. 
Vsako pakiranje vsebuje 1 napolnjen injekcijski peresnik z 2 alkoholnima zložencema, 2 napolnjena peresnika z 2 alkoholnima zložencema ali 4 napolnjene injekcijske peresnike s 4 alkoholnimi zloženci.
If you are not sure if any of the above applies to you, talk to your doctor before you are given Remsima. 
Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom, preden boste prejeli zdravilo Remsima.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PRE-FILLED SYRINGE WITH AUTOMATIC NEEDLE GUARD 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ZA NAPOLNJENO INJEKCIJSKO BRIZGO S SAMODEJNIM
• Rotate the injection site each time you give an injection. 
• Za vsako injiciranje izberite drugo mesto injiciranja.
Acute reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following administration of infliximab. 
v nekaj sekundah) ali v roku nekaj ur po uporabi infliksimaba.
Remove the syringe from the injection site (see Figure G). 
Injekcijsko brizgo izvlecite iz mesta injiciranja (glejte sliko G).
Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis 
perforacija črevesja, stenoza črevesja, divertikulitis,
Remsima 120 mg solution for injection in pre-filled syringe Each 1 mL single dose pre-filled syringe contains 120 mg of infliximab*. 
Remsima 120 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 1-ml enoodmerna napolnjena injekcijska brizga vsebuje 120 mg infliksimaba*.
Re-administration for rheumatoid arthritis 
Ponovna uporaba zdravila pri revmatoidnem artritisu
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab. 
Pri bolnikih, ki so prejemali infliksimab, so opažali tuberkulozo, bakterijske okužbe, vključno s sepso in pljučnico, invazivne glivične, virusne in druge oportunistične okužbe.
• Tell your doctor straight away if you get symptoms of liver problems during treatment with Remsima. 
• Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Remsima pojavijo simptomi težav z jetri.
Remsima 100 mg powder for concentrate infliximab 
Remsima 100 mg prašek za koncentrat infliksimab i.v.
New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia. 
novo nastala in poslabšana psoriaza, vključno s pustulozno psoriazo (predvsem na dlaneh in podplatih), urtikarija,
Invasive fungal infections may present as disseminated rather than localised disease, and antigen and antibody testing may be negative in some patients with active infection. 
poleg tega pa sta lahko pri nekaterih bolnikih z aktivno okužbo testa na antigen in protitelesa negativna.
Fistulising, active Crohn's disease 
Vzdrževalno zdravljenje pri aktivni Crohnovi bolezni s fistulami
Patients should be tested for HBV infection before initiating treatment with infliximab. 
Pred začetkom zdravljenja z infliksimabom, morate bolnike testirati na okužbo z virusom hepatitisa B
The mean terminal half-life ranged from 11.3 days to 13.7 days for 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects. 
Končni razpolovni čas 120-, 180- in 240-mg odmerka subkutanega infliksimaba, ki so bili dani zdravim preiskovancem, se je gibal v razponu od 11,3 dni do 13,7 dni.
Although subcutaneous administration is not indicated for children under age of 18 years, it should be noted that malignancies, some fatal, have been reported among children, adolescents and young adults 
Čeprav pri otrocih, mlajših od 18 let, ni indicirana subkutana aplikacija, je treba upoštevati, da so pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF (začetek zdravljenja je bil pri starosti ≤ 18 let), vključno z infliksimabom, v obdobju trženja poročali o pojavu malignomov, od katerih so bili nekateri smrtni.
The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of <150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose >6 mg/day. 
< 150), ki najmanj 3 tedne niso jemali peroralnih sistemskih kortikosteroidov (prednizona oziroma njemu enakovrednih kortikosteroidov) ali budezonida v odmerku > 6 mg/dan.
Subcutaneous use 
(subkutana uporaba).
Week 22 
6. teden 22. teden
Discontinuation of infliximab therapy should be considered in patients with confirmed significant haematologic abnormalities. 
Pri bolnikih s potrjenimi bistvenimi hematološkimi anomalijami lahko tudi ukinete zdravljenje z infliksimabom.
EU/1/13/853/006 1 pre-filled syringe EU/1/13/853/009 1 pre-filled syringe with automatic needle guard EU/1/13/853/007 2 pre-filled syringes EU/1/13/853/010 2 pre-filled syringes with automatic needle guard EU/1/13/853/008 4 pre-filled syringes EU/1/13/853/011 4 pre-filled syringes with automatic needle guard 
EU/1/13/853/006 1 napolnjena injekcijska brizga EU/1/13/853/009 1 napolnjena injekcijska brizga s samodejnim ščitnikom za iglo EU/1/13/853/007 2 napolnjeni injekcijski brizgi
How to store Remsima 
Shranjevanje zdravila Remsima
Remsima 100 mg powder for concentrate for solution for infusion infliximab 
Remsima 100 mg prašek za koncentrat za raztopino za infundiranje infliksimab
The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, sarcoidosis/sarcoid-like reaction, and serious infusion reactions (see section 4.4). 
TNF povezane neželene učinke zdravila, o katerih so poročali pri uporabi infliksimaba, sodijo reaktivacija HBV, kongestivno srčno popuščanje (CHF - Congestive Heart Failure), resne okužbe (vključno s sepso, oportunističnimi okužbami in TB), serumska bolezen (zapoznele preobčutljivostne reakcije), hematološke reakcije, sistemski eritematozni lupus/lupusu podoben sindrom,
The efficacy of subcutaneous infliximab in rheumatoid arthritis patients was assessed in a randomised, parallel-group pivotal Phase I/III study consisting of two parts: Part 1 to determine the optimal dose of subcutaneous infliximab and Part 2 to demonstrate non-inferiority in terms of efficacy of subcutaneous infliximab compared to intravenous infliximab treatment. 
del je bil namenjen ugotavljanju optimalnega odmerka subkutanega infliksimaba, 2. del pa dokazovanju enakovrednosti z vidika učinkovitosti subkutanega infliksimaba v primerjavi z intravenskim infliksimabom.
Localised injection site reactions predominantly of mild to moderate in nature included the following reactions limited to injection site: erythema, pain, pruritus, swelling, induration, haematoma, oedema, bruising, coldness, irritation, paraesthesia, ulcer, urticaria, haemorrhage, rash and scab were reported to be associated with infliximab subcutaneous treatment. 
V povezavi s subkutanim zdravljenjem z infliksimabom so poročali o lokalnih reakcijah na mestu injiciranja, ki so pretežno blage do zmerne, vključno z naslednjimi reakcijami, ki so omejene na mesto injiciranja: eritem, bolečina, pruritus, oteklina, zatrdlina, hematom, edem, modrica, občutek hladu,
Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in pre-filled pen 
Remsima 120 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Remsima 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Solution for injection 1 pre-filled pen with 2 alcohol pads 2 pre-filled pens with 2 alcohol pads 4 pre-filled pens with 4 alcohol pads 
1 napolnjen injekcijski peresnik z 2 alkoholnima zložencema 2 napolnjena injekcijska peresnika z 2 alkoholnima zložencema 4 napolnjeni injekcijski peresniki s 4 alkoholnimi zloženci
In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%. 
ACCENT I), je bila incidenca reakcij, podobnih serumski bolezni, 2,4 %.
Once you remove the cap, do not recap the syringe. 
Ko enkrat odstranite pokrovček z injekcijske brizge, ga ne smete več namestiti.
Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group 
Ugotovili so, da je bilo treba v terapevtskih skupinah, ki sta prejemali po 5 mg/kg infliksimaba (28/242 ali 11,6 % [nesignifikantno]) oziroma po 10 mg/kg infliksimaba
Under aseptic conditions, each Remsima vial should be reconstituted with 10 mL of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle. 
Uporabite injekcijsko brizgo z iglo 0,8 mm (21 G) ali tanjšo.
Do not reuse the pen in this case. 
tem primeru ga ne vračajte ponovno v hladilnik.
Remsima contains the active substance infliximab. 
Zdravilo Remsima vsebuje učinkovino infliksimab.
Each new injection site should be at least 
Vsako novo mesto injiciranja mora biti od prejšnjega oddaljeno vsaj 3 cm.
(up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤18 years of age), 
Pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab intravenous administration (see section 4.4). 
V okviru izkušenj v obdobju trženja je bila uporaba intravenskega infliksimaba povezana s primeri anafilaktoidnih reakcij, vključno z edemom grla ali žrela in hudega bronhospazma, ter epileptičnimi napadi (glejte poglavje 4.4).
Figure A 
Slika E
Signs of a local injection site reaction can include redness, pain, itching, swelling, hardness, bleeding, bruising, cold sensation, irritation, tingling sensation, ulcer, hives, rash and scab on the skin of the injection site. 
bolečino, srbečico, oteklino, zatrdlino, krvavitev, modrice, občutek hlada, draženje, občutek ščemenja, ulkus, koprivnico, izpuščaj in krasto na koži na mestu injiciranja.
After preparation each mL contains 10 mg of infliximab. 
Po pripravi en ml vsebuje 10 mg infliksimaba.
• 4 prefilled syringes with automatic needle guard (1 mL sterile solution) with 4 alcohol pads. 
• 4 napolnjene injekcijske brizge s samodejnim ščitnikom za iglo (1 ml sterilne raztopine) s 4 alkoholnimi zloženci.
Week 54 among patients who were receiving corticosteroids at baseline. 
in 175 bolnikov v skupini, ki je prejemala zdravilo Remsima v intravenski obliki.
Read carefully these instructions before using the Remsima syringe. 
Pred uporabo injekcijske brizge z zdravilom Remsima natančno preberite ta navodila.
Clear to opalescent, colourless to pale brown solution. 
Bistra do opalescentna in brezbarvna do bledo rjava raztopina.
Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled pen. 
Zdravilo Remsima je bistra do opalescentna in brezbarvna do bledo rjava raztopina, ki je na voljo v napolnjenem injekcijskem peresniku za enkratno uporabo.
Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion. 
Akutna reakcija, vključno z anafilaktično reakcijo, lahko nastopi med infuzijo (t.j.
Endophthalmitis 
Pediatrična
b Absence of any draining fistulas. 
≥ 4 tednov b Bolnik nima nobenih fistul z izcedkom
** PASI 75 response for IMPACT not included due to low N; p<0.001 for infliximab vs. placebo at week 24 for IMPACT 2. 
b Z upoštevanjem bolnikov s PASI ≥ 2,5 na začetku študije IMPACT in tistih s psoriatično prizadetostjo kože ≥ 3 % BSA na začetku študije IMPACT 2 ** Odziv PASI 75 iz študije IMPACT ni vključen zaradi majhnega števila N; p< 0,001 za infliksimab v primerjavi s placebom v 24. tednu v študiji IMPACT 2 V študijah IMPACT in IMPACT 2 so opazili klinični odziv že v 2. tednu, ohranjen pa je bil tudi še v 98. tednu in 54. tednu.
Remsima 120 mg solution for injection in pre-filled pen Remsima 120 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe. 
Zdravilo Remsima 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Remsima 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku, ki vsebuje napolnjeno injekcijsko brizgo, za enkratno uporabo za samoinjiciranje.
• Eye problems including blurred or reduced vision, puffy eyes or sties 
• težave z očmi, vključno z zamegljenim vidom ali slabovidnostjo, otečene oči ali ječmen na očesu, okužba roženice (prozornega dela očesa)
Keep the pre-filled syringe in its package in order to protect from light. 
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
• Do not shake the syringe at any time. 
• Injekcijske brizge ne smete nikoli stresati.
• Tell your doctor straight away if you get symptoms of low blood counts during treatment with Remsima. 
Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Remsima pojavijo simptomi nizkega števila krvnih celic.
Pyelonephritis. 
bolnikov-let.
Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhoea, wounds, dental problems, burning when urinating or ‘flu-like' signs. 
Ti znake so zvišana telesna temperatura, utrujenost, (trdovraten) kašelj, kratka sapa, izguba telesne mase, nočno potenje, driska, rane, težave z zobmi,
• 4 prefilled syringes (1 mL sterile solution) with 4 alcohol pads. 
• 4 napolnjeni injekcijski peresniki (1 ml sterilne raztopine) s 4 alkoholnimi zloženci.
Dispose of the syringe (see Figure H). 
Odložite injekcijsko brizgo (glejte sliko H).
Median (Interquartile range) 
(pregledani bolniki) srednja vr.
Your baby should not receive a ‘live vaccine', such as BCG (used to prevent tuberculosis) within 6 months after birth. 
Vaš dojenček v obdobju 6 mesecev po rojstvu ne sme prejeti "živega cepiva", kot je cepivo
10 mg/kg q 4 wks 
5 mg/kg 10 mg/kg Združeni podatki
Remsima 120 mg solution for injection in pre-filled syringe infliximab 
Remsima 120 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku infliksimab
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PRE-FILLED PEN 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA ZA NAPOLNJEN INJEKCIJSKI PERESNIK
Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi saharoza polisorbat 80 natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat dihidrat
• 2 prefilled syringes with automatic needle guard (1 mL sterile solution) with 2 alcohol pads. 
• 2 napolnjeni injekcijski brizgi s samodejnim ščitnikom za iglo (1 ml sterilne raztopine) z 2 alkoholnima zložencema.
• 1 prefilled syringe with automatic needle guard (1 mL sterile solution) with 2 alcohol pads. 
• 1 napolnjena injekcijska brizga s samodejnim ščitnikom za iglo (1 ml sterilne raztopine) z 2 alkoholnima zložencema.
• Keep this medicine out of the sight and reach of children. 
• Zdravilo shranjujte nedosegljivo otrokom.
b. Lift the pen from the injection site (see Figure H). 
b. Injekcijski peresnik umaknite z mesta injiciranja (glejte Slika H).
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus. 
Pri bolnikih, ki so prejemali zaviralec TNF, na primer infliksimab, in ki so bili kronični prenašalci virusa hepatitisa B, je prišlo do reaktivacije hepatitisa B. V nekaterih primerih je prišlo celo do smrti bolnika.
• Tell your doctor straight away if you develop symptoms of lupus during treatment with Remsima. 
Takoj obvestite zdravnika, če se med zdravljenjem z zdravilom Remsima pojavijo simptomi lupusa.
The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI by ≥70 points from baseline at the 4-week evaluation and without an increase in the use of medicinal products or surgery for Crohn's disease. 
za ≥ 70 točk od izhodiščne vrednosti ob pregledu v 4. tednu zdravljenja, z nespremenjeno potrebo po zdravilih ali operativnih posegih za zdravljenje Crohnove bolezni.
Patients must be monitored closely for infections including tuberculosis before, during and after treatment with infliximab. 
Okužbe Pred, med in po zdravljenju z infliksimabom morate bolnike skrbno spremljati, da ugotovite morebitne okužbe, vključno s tuberkulozo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR PRE-FILLED SYRINGE WITH AUTOMATIC NEEDLE GUARD 
NALEPKA NA NAPOLNJENI INJEKCIJSKI BRIZGI S SAMODEJNIM ŠČITNIKOM ZA IGLO
Controla 
pielonefritis
Please read the Remsima ‘Package Leaflet' carefully before you start using this medicine. 
Preden začnete uporabljati to zdravilo, natančno preberite navodilo za uporabo.
Mean ± SDa 
Bat brizge
Median 
ZDRAVILA
Peripheral blood mononuclear cells (PBMC) from infliximab-treated patients showed undiminished proliferative responsiveness to stimuli compared with untreated patients, and no substantial changes in cytokine production by stimulated PBMC were observed following treatment with infliximab. 
Ne število limfocitov v periferni krvi ne njihov proliferacijski odziv na mitogeno stimulacijo in vitro se pri bolnikih, zdravljenih z infliksimabom, nista bistveno zmanjšala v primerjavi s celicami nezdravljenih bolnikov
• You may get infections more easily when you are being treated with Remsima. 
• Med zdravljenjem z zdravilom Remsima se lahko poveča dovzetnost za okužbe.
• In case you have received Remsima while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine. 
Remsima, je pomembno, da o tem obvestite zdravnika vašega dojenčka, preden dojenček prejme katero koli cepivo.
• Pain. 
(HBV).
Each 1 ml single dose pre-filled syringe contains 120 mg of infliximab. 
Ena 1-ml enoodmerna napolnjena injekcijska brizga vsebuje 120 mg infliksimaba.
• 4 prefilled pens (1 mL sterile solution) with 4 alcohol pads. 
• 4 napolnjene injekcijske brizge (1 ml sterilne raztopine) s 4 alkoholnimi zloženci.
At week 16, 47 placebo patients with <10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape). 
< 10 % izboljšanjem stanja glede na začetek študije - tako glede števila oteklih kot bolečih sklepov prešlo na uvedbo infliksimaba (zgodnji umik).