natgillin/translations-raw huggingface dataset:
Remsima 120 mg solution for injection in pre-filled syringe Remsima 120 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (flurotec-coated elastomer) and needle with a rigid needle shield. 
Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki (staklo tip I) za jednokratnu primjenu s čepom klipa (elastomer presvučen flurotekom) i iglom s čvrstim štitnikom igle.
• Children should receive recommended vaccinations before starting Remsima treatment. 
• Prije započinjanja liječenja lijekom Remsima djeca trebaju primiti preporučena cjepiva.
Crohn's disease2 
Crohnova bolest2
Overall, the adverse reactions reported in the paediatric ulcerative colitis trial (C0168T72) and adult ulcerative colitis (ACT 1 and ACT 2) studies were generally consistent. 
(C0168T72) i odraslih (ACT 1 i ACT 2) općenito su bile konzistentne.
The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years. 
Sigurnost i djelotvornost infliksimaba nisu ispitivani u djece mlađe od 6 godina koja boluju od ulceroznog kolitisa.
It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remsima therapy. 
Preporučuje se da, ako je to moguće, prije početka liječenja lijekom Remsima bolesnici prime sva cjepiva u skladu s važećim smjernicama za cijepljenje.
PGA of cleared (0) or minimal (1) 
Poboljšanje ≥ 50% PGA čist (0) ili minimalan (1)
Table 2 Proportion of patients with increased ALT activity in clinical studies using intravenous infliximab 
Udio bolesnika s povišenom aktivnošću ALT-a u kliničkim ispitivanjima s intravenskim imfliksimabom
e 
I
Name doctor: 
Ime bolesnika: Ime liječnika:
Signs include shortness of breath or swelling of your feet. 
Znakovi obuhvaćaju nedostatak zraka ili oticanje stopala.
1 pre-filled syringe with 2 alcohol pads 1 pre-filled syringe with needle guard with 2 alcohol pads 2 pre-filled syringes with 2 alcohol pads 2 pre-filled syringes with needle guard with 2 alcohol pads 4 pre-filled syringes with 4 alcohol pads 4 pre-filled syringes with needle guard with 4 alcohol pads 
1 napunjena štrcaljka s 2 jastučića natopljena alkoholom 1 napunjena štrcaljka sa štitnikom igle s 2 jastučića natopljena alkoholom 2 napunjene štrcaljke s 2 jastučića natopljena alkoholom 2 napunjene štrcaljke sa štitnikom igle s 2 jastučića natopljena alkoholom 4 napunjene štrcaljke s 4 jastučića natopljena alkoholom 4 napunjene štrcaljke sa štitnikom igle s 4 jastučića natopljena alkoholom
1 hour. 
tjedna.
If serious reactions occur, symptomatic treatment must be given and further infliximab must not be administered (see section 4.8). 
Ako se pojave ozbiljne reakcije, mora se primijeniti simptomatska terapija i više se ne smije davati infliksimab (vidjeti dio 4.8).
• Tell your doctor straight away if you develop symptoms of lupus during treatment with Remsima. 
• Odmah obavijestite Vašeg liječnika ako razvijete simptome lupusa za vrijeme liječenja lijekom Remsima.
Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and in the case of intravenously administered infliximab, a reduction in the frequency of infusion reactions. 
Istodobna primjena imunomodulatora povezana je s nižom incidencijom protutijela na infliksimab i kod slučajeva intravenske primjene infliksimaba, smanjenom učestalošću reakcija vezanih uz infuziju.
Remsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. 
Remsima je indicirana za liječenje teškog oblika aktivnog ulceroznog kolitisa u djece i adolescenata u dobi između 6 i 17 godina koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju uključujući kortikosteroide i 6-MP ili AZA, odnosno u onih koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
Currently available data are described in section 5.2 but no recommendation on a posology can be made. 
Do sada dostupni podaci opisani su u dijelu 5.2, ali ne mogu se dati preporuke za doziranje.
Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions when administered by intravenous infusion. 
Mogu se razviti protutijela na infliksimab koja su povezana s povećanom učestalošću reakcija vezanih uz infuziju kad se infuzija daje intravenski.
Clinical Responsea 
Klinički odgovora Klinička remisija
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 
Iako supkutana primjena nije indicirana u djece mlađe od 18 godina, potrebno je imati na umu da su zloćudne bolesti, neke sa smrtnim ishodom, prijavljene u djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni TNF-blokatorima (liječenje započeto u dobi
Consult your healthcare provider if you have questions about using the Remsima syringe. 
Obratite se svom liječniku ako imate pitanja u vezi primjene Remsima štrcaljke.
Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, 
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Imunosupresivi, inhibitori faktora nekroze tumora alfa (TNFα), ATK
Signs include persistent cough, weight loss, feeling tired, fever, night sweats. 
Znakovi obuhvaćaju ustrajan kašalj, gubitak tjelesne težine, umor, vrućicu, noćno znojenje.
Tel.: + 48 22 417 9200 recepcja@egis.pl 
EGIS Polska Dystrybucja Sp. z o.o. Tel.: + 48 22 417 9200 recepcja@egis.pl
Rheumatoid arthritis1 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate. 
Reumatoid ni artritis1 1 Bolesnici u placebo skupini primali su metotreksat, dok su bolesnici u infliksimab skupini primali i infliksimab i metotreksat.
In rheumatoid arthritis 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. 
Ima naznaka da istodobna primjena metotreksata i drugih imunomodulatora u bolesnika s reumatoidnim artritisom, smanjuje stvaranje protutijela protiv infliksimaba i povećava koncentraciju infliksimaba u plazmi.
Cyanosis, pericardial effusion 
cijanoza, perikardijalni izljev
In phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction. 
U kliničkim ispitivanjima faze III reakciju vezanu uz infuziju razvilo je 18% bolesnika liječenih infliksimabom u odnosu na 5%
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). 
47 bolesnika koji su primali placebo i u odnosu na početno stanje imali < 10% poboljšanja s obzirom na broj otečenih i bolnih zglobova prebačeno na uvodnu terapiju infliksimabom (rani bijeg).
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Remsima. 
Ako niste sigurni odnosi li se nešto od navedenog na Vas, porazgovarajte s Vašim liječnikom, ljekarnikom ili medicinskom sestrom prije nego primite lijek Remsima.
a. Select an injection site. 
Izaberite mjesto primjene injekcije.
If these medicines do not work well enough, you will be given Remsima to treat your disease. 
Ako ti lijekovi ne djeluju dovoljno dobro, za liječenje bolesti dobit ćete lijek Remsima.
Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis. 
Liječenje lijekom Remsima uvodi se i provodi pod nadzorom liječnika specijaliste s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa, upalnih bolesti crijeva, ankilozantnog spondilitisa,
Patients with a PGA score ≥3 were eligible to receive an additional infusion of the same treatment at week 26. 
Physician Global Assessment, PGA) imali ≥ 3 boda, zadovoljili su kriterije da još jednom prime istu infuziju u 26. tjednu.
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. 
Lokalizirane reakcije na mjestu injekcije su pretežno blagog do umjerenog oblika, uključujući sljedeće reakcije ograničene na mjesto injekcije: eritem, bol, svrbež, oticanje, induracija, hematom, edem, modrice, osjećaj hladnoće, nadraženost, parestezija, čir, urtikarija, krvarenje, osip i krasta prijavljeni su kao povezani sa supkutanim liječenjem infliksimabom.
Concurrent use of stable doses of oral corticosteroids (≤10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given. 
Dopuštala se istodobna primjena ustaljenih doza peroralnih kortikosteroida (≤ 10 mg/dan) i/ili nesteroidnih protuupalnih lijekova, a davala se i nadomjesna terapija folatima.
In the REACH study, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn's disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6. 
Crohnova bolest u pedijatrijskih bolesnika (6 do 17 godina) U kliničkom ispitivanju REACH, 112 bolesnika (raspon dobi: 6-17 godina, medijan 13 godina) s umjerenom do teškom, aktivnom Crohnovom bolešću (srednji pedijatrijski CDAI bio je 40) i neodgovarajućim odgovorom na konvencionalnu terapiju primilo je infliksimab u dozi od 5 mg/kg u
Percentage ACR improvement 
Broj randomiziranih ispitanika Postotak poboljšanja ACR odgovora
b. Remove the syringe from the carton stored in your refrigerator by holding the middle of the syringe body. 
Štrcaljku izvadite iz kutije držeći za sredinu tijela štrcaljke.
The required volume of the reconstituted Remsima solution should be diluted to 250 mL with sodium chloride 9 mg/mL (0.9%) solution for infusion. 
Potrebni volumen rekonstituirane otopine lijeka Remsima trebate razrijediti s otopinom natrijevog klorida od 9 mg/ml (0,9%) za infuziju do ukupnog volumena od 250 ml.
No major age-related differences in clearance or volume of distribution were observed in clinical studies with infliximab intravenous formulations and the same is expected for subcutaneous formulation. 
U kliničkim ispitivanjima s intravenskim formulacijama infliksimaba nisu opažene veće dobno uvjetovane razlike u klirensu i volumenu distribucije lijeka, a isto se očekuje i za supkutane formulacije.
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥10% and Psoriasis Area and Severity Index [PASI] score ≥12). 
Psoriasis Area and Severity Index [PASI] ≥ 12).
Start the injection (see Figure F). 
Započnite ubrizgavanje (vidjeti Sliku F).
The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion from the 250-mL glass bottle or infusion bag equal to the volume of reconstituted Remsima. 
Razrjeđivanje se može provesti tako da se iz 250-mililitarske staklene boce ili vrećice za infuziju s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju izvuče volumen jednak volumenu rekonstituirane otopine lijeka Remsima.
At week 12, the number of BASDAI 50 responders were 3/35 (9%) in the placebo group, and 20/35 (57%) in the 5 mg/kg group (p<0.01). 
12. tjednu, klinički odgovor BASDAI 50 imalo je 3 od 35 (9%) bolesnika u skupini koja je primala placebo i 20 od 35 (57%) bolesnika u skupini koja je primala infliksimab u dozi od 5 mg/kg (p < 0,01).
Package leaflet: Information for the user Remsima 100 mg powder for concentrate for solution for infusion infliximab 
Uputa o lijeku: Informacije za korisnika Remsima 100 mg prašak za koncentrat za otopinu za infuziju
Do not use the pen if: 
Nemojte primijeniti brizgalicu:
At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p<0.001). 
klinički odgovor ASAS 20 imalo je 15 od 78 (19%) bolesnika u skupini koja je primala placebo i 123 od 201 (61%) bolesnika u skupini koja je primala infliksimab u dozi od 5 mg/kg (p < 0,001).
Powder for concentrate for solution for infusion (powder for concentrate) The powder is white. 
Prašak za koncentrat za otopinu za infuziju (prašak za koncentrat).
Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blocking agents including infliximab. 
Nakon stavljanja u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica (HSTCL, engl. hepatosplenic T-cell lymphoma) u bolesnika liječenih TNF-blokatorima uključujući infliksimab.
Infliximab (Week 54) 
Infliksima b (54. tjedan
Clinical Remission 
KLINIČKI PODACI
• Cancer 
• rak
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. 
Znakovi lokalne reakcije na mjestu injekcije mogu uključiti crvenilo, bol, svrbež, oticanje, otvrdnuće, krvarenje, modrice, osjećaj hladnoće, nadraženost, trnce, čir, koprivnjaču, osip i krastu na koži na mjestu injekcije.
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 napunjena štrcaljka EU/1/13/853/009 1 napunjena štrcaljka s automatskim štitnikom igle EU/1/13/853/007 2 napunjene štrcaljke EU/1/13/853/010 2 napunjene štrcaljke s automatskim štitnikom igle EU/1/13/853/008 4 napunjene štrcaljke EU/1/13/853/011 4 napunjene štrcaljke s automatskim štitnikom igle
Tel: + 421 2 3240 9422 info@egis.sk 
Egis Slovakia spol.s r.o. Tel: + 421 2 3240 9422 info@egis.sk
Excipients: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate. 
Pomoćne tvari: saharoza, polisorbat 80, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat.
New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia. 
(primarno palmarnu i plantarnu), urtikarija, osip, svrbež, hiperhidroza, suha koža, gljivični dermatitis, ekcem, alopecija
Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button. 
Staklena bočica (staklo tip 1) s gumenim čepom i aluminijskim prstenom zaštićenim plastičnim zatvaračem.
Remsima 120 mg solution for injection in pre-filled syringe or in pre-filled pen are administered by subcutaneous injection only. 
Remsima 120 mg otopina za injekciju u napunjenoj štrcaljki ili napunjenoj brizgalici primjenjuju se samo kao supkutane injekcije.
• Signs of an immune system disorder called lupus such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis). 
• Znakove poremećaja imunološkog sustava kao što su bol u zglobovima ili osip na obrazima ili rukama osjetljiv na sunce (lupus) ili kašalj, nedostatak zraka, vrućica ili kožni osip
The pharmacokinetics of infliximab injected via subcutaneous route in elderly patients has not been studied. 
Farmakokinetika infliksimaba injektiranog supkutano u starijih bolesnika nije ispitivana.
2 Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase. 
ACCENT II, primili su inicijalnu dozu infliksimaba od 5 mg/kg na početku ispitivanja, dok su u fazi održavanja primali placebo.
Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10). 
Djelotvornost i sigurnost infliksimaba ocjenjivale su se u dva multicentrična, dvostruko slijepa, placebom kontrolirana ispitivanja u bolesnika s aktivnim ankilozantnim spondilitisom (rezultat ≥ 4
Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50. 
Sažeti prikaz PASI odgovora, PGA odgovora i postotka bolesnika bez psorijatičnih promjena na noktima u 10., 24. i 50. tjednu, EXPRESS
How much Remsima is given 
Koliko lijeka Remsima ćete primiti
• Some patients receiving infliximab have developed serious liver problems. 
• U nekih bolesnika koji primaju infliksimab razvile su se ozbilljne jetrene tegobe.
Infliximab Placebo 5 mg/kg 10 mg/kg Combined 
Placebo + MTX 3 mg/kg 6 mg/kg Kombinirano
a. Clean the injection site with an alcohol swab. 
Očistite mjesto primjene jastučićem natopljenom alkoholom.
When starting a new card, please keep this card as a reference for 4 months after your last dose of Remsima. 
Kada dobijete novu karticu, nastavite čuvati ovu karticu za potrebe provjere još 4 mjeseca nakon posljednje doze lijeka Remsima.
Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remsima. 
Odmah obavijestite svog liječnika ako dobijete nove znakove zatajenja srca ili se postojeći simptomi pogoršaju tijekom liječenja lijekom Remsima.
Keep the pre-filled syringe in its package in order to protect from light. 
Napunjenu štrcaljku čuvati u originalnom pakiranju radi zaštite od svjetlosti.
• Fungal infections such as yeast infection, or fungal infection of the nails 
• gljivične infekcije kao što su infekcije uzrokovane kvascima ili gljivične infekcije noktiju
Patients treated with Remsima should be given the package leaflet and the patient reminder card. 
Bolesnici koji se liječe lijekom Remsima moraju dobiti uputu o lijeku i karticu s podsjetnikom za bolesnika.
Infliximab (Week 24) 
Infliksima b (24. tjedan
Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4). 
> 5% uključuju pneumocistozu, kandidijazu, listeriozu i aspergilozu (vidjeti dio 4.4).
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE
Remsima 100 mg powder for concentrate for solution for infusion 
Remsima 100 mg prašak za koncentrat za otopinu za infuziju
EU/1/13/853/006 EU/1/13/853/007 EU/1/13/853/008 EU/1/13/853/009 EU/1/13/853/010 EU/1/13/853/011 EU/1/13/853/012 EU/1/13/853/013 EU/1/13/853/014 
EU/1/13/853/006 EU/1/13/853/007 EU/1/13/853/008 EU/1/13/853/009 EU/1/13/853/010 EU/1/13/853/011 EU/1/13/853/012 EU/1/13/853/013
In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks. 
stupnja III-IV (ejekcijska frakcija lijeve klijetke ≤ 35%) liječeno sa 3 infuzije lijeka infliksimab u dozi od 5 mg/kg odnosno 10 mg/kg ili je primalo placebo tijekom 6 tjedana.
Give the injection (see Figure F). 
Ubrizgavanje injekcije (vidjeti Sliku F).
If the dose is delayed by 8 days or more, the patients should be instructed to skip the missed dose, wait until their next scheduled dose, and then remain on their original bi-weekly dosing schedule. 
bolesnike se mora uputiti da preskoče propuštenu dozu i da pričekaju do iduće predviđene doze, a zatim da nastave s prvobitnim doziranjem svaka dva tjedna.
Improvement from baseline in HAQ averaged over time from week 30 to week 54c Mean ± SDd a p <0.001, for each infliximab treatment group vs control. 
Prosjek poboljšanja HAQ od početne vrijednosti tijekom razdoblja od 30. do 54. tjednac Prosječna vrijednost ± SDd a p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu. b veće vrijednosti znače jače oštećenje zgloba.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PRE-FILLED PEN 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE ZA NAPUNJENU BRIZGALICU
At 38 weeks, 9 of 101 patients treated with infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo. 
od 101 bolesnika liječenih lijekom infliksimab (dvoje koji su primali dozu od 5 mg/kg i sedmero koji su primali dozu od 10 mg/kg), dok je među 49 bolesnika koji su primali placebo zabilježen samo jedan smrtni slučaj.
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). 
Najozbiljnije nuspojave povezane s primjenom TNF-blokatora, koje su prijavljene za infliksimab, uključuju reaktivaciju hepatitisa B (HBV), kongestivno zatajenje srca, teške infekcije (uključujući sepsu, oportunističke infekcije i tuberkulozu), serumsku bolest (reakcija kasne preosjetljivosti), hematološke reakcije, sistemski eritematozni lupus/sindrom sličan lupusu, demijelinizacijske poremećaje, poremećaje jetre i žuči, limfom, hepatosplenički limfom T-stanica,
Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25°C after removal from refrigeration. 
Nakon rekonstitucije i razrjeđivanja: Dokazana je kemijska i fizikalna stabilnost razrijeđene otopine do 28 dana na temperaturi od 2°C do
Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established. 
Sigurnost i djelotvornost infliksimaba nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog idiopatskog artritisa, psorijatičnog artritisa i ankilozantnog spondilitisa.
Infliximab (Week 16) 
Infliksima b (16. tjedan
In Crohn's disease patients who received maintenance treatment, antibodies to infliximab occurred overall in 3.3% of patients receiving immunosuppressants and in 13.3% of patients not receiving immunosuppressants. 
3,3% bolesnika koji su primali imunosupresive i 13,3% bolesnika koji nisu primali imunosupresive razvilo protutijela protiv infliksimaba.
Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials with infliximab, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients. 
Najčešće nuspojave prijavljene u kliničkim ispitivanjima s infliksimabom bile su infekcije gornjih dišnih puteva, koje su nastupile u 25,3% bolesnika liječenih infliksimabom u odnosu na 16,5%
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥220 ≤450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years. 
Infliksimab sa ili bez AZA ispitivao se u randomiziranom, dvostruko slijepom ispitivanju s aktivnom kontrolom (SONIC) u 508 odraslih bolesnika sa srednje teškom do teškom Crohnovom bolešću