natgillin/translations-raw huggingface dataset:
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).
Najpogosteje prijavljene oportunistične okužbe s stopnjo smrtnosti > 5 % so bile pnevmocistoza, kandidiaza, listerioza in aspergiloza (glejte poglavje 4.4).
This medicine contains 45 mg sorbitol in each 120 mg dose.
To zdravilo vsebuje 45 mg Sorbitola na en 120-mg odmerek.
Table 1 Adverse reactions in clinical studies and from post-marketing experience of intravenous infliximab
Neželeni učinki v kliničnih študijah in iz obdobja trženja intravenskega infliksimaba
• Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
• resne težave z živčevjem, na primer transverzni mielitis, multipli sklerozi podobna bolezen, vnetje vidnega živca in Guillain-Barréjev sindrom
In the Phase IIIb trial in Crohn's disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
IIIb faze SONIC pri bolnikih s Crohnovo boleznijo, so bolniki iz placebo skupine, poleg placebo infuzij infliksimaba, prejemali kot kontrolno učinkovino AZA v odmerku 2,5 mg/kg na dan.
• Tell your doctor before you are given Remsima if you have or have ever had a problem that affects your nervous system.
• Preden prejmete zdravilo Remsima, povejte zdravniku, če imate ali ste kdaj prej že imeli kakršne koli nevrološke težave.
• Signs of a nervous system problem (including eye problems) such as fits, tingling or numbness in any part of your body, weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
• znaki težav z živčevjem (vključno s težavami z očmi), na primer epileptični napadi, mravljinci ali občutek odrevenelosti v kateremkoli delu telesa, šibkost rok ali nog, spremembe vida, na primer dvojni vid ali druge težave z očmi.
For intravenous use after reconstitution and dilution
intravenska uporaba po rekonstituciji in redčenju.
e
O
In the RA patients, the mean (± standard deviation) clearance of Remsima 120 mg subcutaneously was 18.8 ± 8.3 mL/hr at steady state.
Pri bolnikih z RA je mediana (± standardni odklon) navideznega očistka subkutano danega zdravila Remsima 120 mg znašala 18,8 ± 8,3 ml/uro v dinamičnem ravnovesju.
Almost all patients had also received medicines containing azathioprine or mercaptopurine in addition to TNF-blockers.
Skoraj vsi bolniki so poleg zaviralcev TNF prejeli tudi zdravila, ki vsebujejo azatioprin ali merkaptopurin.
PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2)
PGA brez plakov (0) ali minimalni (1) PGA brez plakov (0), minimalni (1), ali blagi
Remsima subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
Zdravilo Remsima za subkutano uporabo ni indicirano za intravensko dajanje, zato jo je treba odmerjati izključno s subkutanim injiciranjem.
There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab.
Iz obdobja trženja obstajajo poročila o poslabševanju srčnega popuščanja pri bolnikih, ki so jemali infliksimab, z ali brez poznanih dejavnikov, ki bi lahko poslabšali stanje.
Proportions of Patients Achieving Clinical Response According to the ACR Criteria ACR20
Deleži bolnikov, ki so po merilih ACR dosegli klinični odziv
Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate.
Bolnike poučite o potencialnih dejavnikih tveganja za okužbe in jim svetujte, naj se izogibajo izpostavljanju le-tem.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Zdravilo Remsima vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni “brez natrija”.
When switching from the maintenance therapy of infliximab intravenous formulation to the subcutaneous formulation of Remsima, the subcutaneous formulation may be administered 8 weeks after the last administration of the intravenous infusions of infliximab 3 mg/kg given every 8 weeks.
Ob prehodu z vzdrževalnega zdravljenja z infliksimabom v intravenski obliki na zdravilo Remsima v subkutani obliki lahko zdravilo v subkutani obliki daste 8 tednov po zadnji intravenski infuziji infliksimaba 3 mg/kg na vsakih 8 tednov.
Upon removal from refrigerated storage, Remsima must not be returned to refrigerated storage.
Ko zdravilo Remsima enkrat vzamete iz hladilnika, ga ne smete vrniti nazaj v hladilnik.
The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Varnost in učinkovitost infliksimaba so ocenili v dveh randomiziranih, dvojno slepih in s placebom kontroliranih kliničnih študijah (ACT 1 in ACT 2) pri odraslih bolnikih z zmerno do močno aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12; delna endoskopska ocena ≥ 2), ki so se nezadostno odzvali na običajno zdravljenje [s peroralnimi kortikosteroidi, aminosalicilati in/ali imunomodulatorji (6-MP, AZA)].
The safety population consisted of 168 patients in the Remsima subcutaneous group and 175 patients in the Remsima intravenous group.
Varnostna populacija je sestavljala 168 bolnikov v skupini, ki je prejemala zdravilo Remsima v subkutani obliki,
PGA of cleared (0), minimal (1), or mild (2)
PGA brez plakov (0), minimalni (1), ali blagi
If you forget to use Remsima
Če ste pozabili uporabiti odmerek zdravila Remsima
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.
Uporabo infliksimaba z ali brez AZA so ovrednotili v randomizirani, dvojno slepi študiji s kontrolno učinkovino (SONIC) pri 508 odraslih bolnikih z zmerno do hudo obliko Crohnove bolezni (CDAI ≥ 220 ≤ 450), ki pred tem niso še nikoli prejemali bioloških zdravil ali imunosupresivov in je bila pri njih mediana vrednost trajanja bolezni 2,3 leta.
• Patients taking Remsima may have an increased risk of developing lymphoma or another cancer.
• Bolniki, ki prejemajo zdravilo Remsima, imajo lahko povečano tveganje za pojav limfoma ali katere druge vrste raka.
In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
V študijah ACT 1 in ACT 2 je infliksimab tudi izboljšal kakovost življenja bolnikov, kar je bilo potrjeno s statistično značilnim izboljšanjem rezultata vprašalnika za oceno vnetnih bolezni črevesja IBDQ, ki je specifičen za to bolezen, in z izboljšanjem rezultatov generične kratke ankete
a. Put the used syringe in an approved sharps disposal container immediately after use.
a. Uporabljeno injekcijsko brizgo takoj po uporabi zavrzite v odobren vsebnik za ostre odpadke.
Excipients: acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80, water for injections
Pomožne snovi: ocetna kislina, natrijev acetat trihidrat, sorbitol, polisorbat 80, voda za injekcije
What Remsima is and what it is used for What you need to know before you use Remsima How Remsima will be given Possible side effects
Kaj je zdravilo Remsima in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Remsima Kako boste dobivali zdravilo Remsima
If you are given too much Remsima
Če ste prejeli prevelik odmerek zdravila Remsima
The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.
Priporočeni odmerek zdravila Remsima za subkutano uporabo je 120 mg enkrat na dva tedna.
Full instructions for use are provided in the package leaflet.
Celotna navodila za uporabo zdravila so na voljo na navodilu za uporabo.
Peripheral ischaemia, thrombophlebitis, haematoma
periferna ishemija, tromboflebitis, hematom redki:
If these medicines do not work well enough, you will be given Remsima to treat your disease.
Če ta zdravila ne delujejo dovolj dobro delovala, boste prejeli zdravilo Remsima za zdravljenje vaše bolezni.
If you miss a dose of Remsima for up to 7 days, after the original scheduled dose, you should take the missed dose immediately.
Če odmerek zdravila Remsima zamudite do 7 dni, morate po prvotnem načrtovanem odmerku takoj odvzeti izpuščeni odmerek.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment (see section 5.1).
nadaljevanju terapije pa temeljito premislite pri bolnikih, ki v prvih 12 tednih zdravljenja ne kažejo nikakršnih znakov, da jim zdravljenje koristi (glejte poglavje 5.1).
Therefore, the combination of infliximab and anakinra is not recommended.
Kombiniranje zdravila infliksimaba in anakinre torej ni priporočljivo.
Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC
Odstotek bolnikov, ki so dosegli klinično remisijo brez jemanja kortikosteroidov v 26. tednu,
The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leukopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Pri otrocih so se pogosteje pojavili naslednji neželeni učinki: nizko število rdečih krvnih celic (anemija), kri v blatu, nizko celokupno število belih krvnih celic (levkopenija), rdečica ali zardevanje, virusne okužbe, nizko število belih krvnih celic, ki se borijo proti okužbi
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Na podlagi severnoevropske opazovalne študije so pri ženskah, ki so bile v nosečnosti izpostavljene infliksimabu (z ali brez imunomodulatorjev/kortikosteroidov, 270 nosečnosti), v primerjavi z ženskami, ki so bile izpostavljene samo imunomodulatorjem in/ali kortikosteroidom (6.460 nosečnosti), opazili zvečano tveganje (OR; 95 % IZ; vrednost p) za carski rez (1,50; 1,14 - 1,96; p = 0,0032), prezgodnji porod (1,48; 1,05 - 2,09; p = 0,024), majhnost glede na gestacijsko starost (2,79; 1,54 - 5,04; p = 0,0007) in nizko porodno težo (2,03; 1,41 - 2,94; p = 0,0002).
a. Hold the syringe by its body in one hand between your thumb and index finger.
a. Injekcijsko brizgo primite za ohišje s palcem in kazalcem.
• The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80 and water for injections.
• Pomožne snovi so ocetna kislina, natrijev acetat trihidrat, sorbitol, polisorbat 80 in voda za injekcije.
In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n=78) or 5 mg/kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
V drugem preskušanju (ASSERT) so 279 bolnikov naključno razporedili bodisi v skupino, ki bo prejemala placebo (1. skupina, n = 78), ali pa v skupino, ki bo prejemala infliksimab v odmerku 5 mg/kg (2. skupina, n=201) v 0., 2. in 6. tednu in kasneje na vsakih 6 tednov, do 24. tedna.
In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing 941 patient years.
V kliničnih študijah z infliksimabom, v katerih je bilo zdravljenih 5.780 bolnikov, to pomeni skupaj 5.494 bolnikov let, so odkrili 5 primerov limfoma in 26 nelimfomskih rakavih bolezni, pri 1.600 s placebom zdravljenih bolnikih, to pomeni skupaj 941 bolnikovih-let, pa nič limfomov in 1 nelimfomsko rakavo bolezen.
Infliximab Maintenance (5 mg/kg) (n=96)
Vzdrževalno zdravljenje z infliksimabom (5 mg/kg) (n=96)
Induction treatment in fistulising active Crohn's disease The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulae that were of at least 3 months' duration.
Učinkovitost zdravila so ocenjevali tudi v randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 94 bolnikih s Crohnovo boleznijo s fistulami, ki so trajale najmanj 3 mesece.
• The outer area of the upper arms (caregiver ONLY).
• Zunanji del nadlahti (to smejo izvajati SAMO negovalci).
A population-based retrospective cohort study using data from Swedish national health registries found an increased incidence of cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, including those over 60 years of age.
V populacijski retrospektivni kohortni študiji, v kateri so uporabili podatke iz švedskih nacionalnih zdravstvenih registrov, so ugotovili povečano pojavnost raka materničnega vratu pri ženskah z revmatoidnim artritisom zdravljenih z infliksimabom, v primerjavi z bolnicami, ki še niso prejemale bioloških zdravil, ali s splošno populacijo, vključno s starejšimi od 60 let.
• If you received Remsima while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
• Če ste zdravilo Remsima prejemali v času nosečnosti, lahko tudi pri vašem dojenčku še šest mesecev po rojstvu obstaja večje tveganje, za okužbo z živimi cepivi.
In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
V podskupini 90 odraslih bolnikov z revmatoidnim artritisom iz študije ASPIRE se je učinkovito dvakratno zvišanje titrov protiteles pri polivalentnem pnevmokoknem cepivu pokazalo pri podobnem deležu bolnikov iz vsake zdravljene skupine (metotreksat in: placebo [n = 17], infliksimab 3 mg/kg [n = 27] ali 6 mg/kg [n = 46]), kar kaže, da infliksimab ni motil od celic T neodvisne humoralne imunske odgovore.
Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNFα), oznaka ATC: L04AB02.
b n = 292. c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
c Analiza se nanaša na preiskovance, ki so imeli psoriazo nohtov na začetku študije (81,8 % preiskovancev).
Remsima contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Zdravilo Remsima vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje infliksimab, za vse podskupine pediatrične populacije z revmatoidnim artritisom, juvenilnim idiopatskim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom in psoriazo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Indication Number of patients3 Median follow-up (wks)4
Mediana dolžina spremljanja bolnikov (tedni)4
The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.
Običajni priporočeni odmerek zdravila Remsima za subkutano injiciranje je 120 mg enkrat na dva tedna ne glede na telesno maso.
b. Gently press a cotton ball or gauze over the injection site and hold for 10 seconds.
b. Kosem vate ali gazo nežno pritisnite na mesto injiciranja in ga pridržite za 10 sekund.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
• Tell your doctor before you are given Remsima if you have an infection even if it is a very minor one.
• Preden prejmete zdravilo Remsima, povejte zdravniku, če imate okužbo, tudi če je zelo blaga.
If you were using Remsima during pregnancy, tell your baby's doctor and other health care professionals caring for your baby about your Remsima use before the baby receives any vaccines.
Če ste prejemali zdravilo Remsima med nosečnostjo, je pomembno, da o tem obvestite otrokovega zdravnika in druge zdravstvene delavce, ki skrbijo za vašega dojenčka, preden vaš dojenček prejme katerokoli cepivo.
Do not dilute the reconstituted Remsima solution with any other diluent.
Rekonstituirane raztopine zdravila Remsima ne redčite z nobeno drugo tekočino.
Contents of the pack and other information
Shranjevanje zdravila Remsima Vsebina pakiranja in dodatne informacije
Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Uporaba povzročiteljev okužb, kot so žive oslabljene bakterije (npr. instilacija BCG v sečni mehur za zdravljenje raka), v druge terapevtske namene lahko povzroči klinične okužbe, vključno z razsejanimi okužbami, zato priporočamo, da jih ne dajete sočasno z infliksimabom.
Infliximab Maintenance 5 mg/kg (n=113) (p value)
Vzdrževalno zdravljenje z infliksimabom 5 mg/kg (n=113) (p vrednost)
Table 1 Adverse reactions in clinical studies and from post-marketing experience
Neželeni učinki v kliničnih študijah in iz obdobja trženja zdravila
Single subcutaneous injections of 120, 180 and 240 mg of infliximab yielded approximately dose proportional increases in the maximum serum concentration (Cmax) and area under the concentrationtime curve (AUC).
Približno sorazmerno s povečanjem enkratnega odmerka infliksimaba 120, 180 in 240 mg v subkutanih injekcijah sta se povečali tudi največja koncentracija tega zdravila v serumu (Cmaks) in površina pod krivuljo koncentracije po času (AUC).
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Če je ne uporabite takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik in navadno to ne bi smelo presegati 24 ur pri temperaturi 2°C - 8°C, razen če je rekonstitucija/redčenje potekala(o) v nadzorovanih in validiranih aseptičnih pogojih.
The apparent volume of distribution during the terminal phase (mean of 7.3 to 8.8 litres) was not dependent on the administered dose.
(povprečje od 7,3 do 8,8 litra) ni bil odvisen od danega odmerka
The medicinal product must be discarded if not used within the 14-day period.
Če zdravila ne uporabite v 14 dneh,
However, before Remsima is given to you, it is mixed with a solution that contains sodium.
Zdravilo Remsima je pred uporabo zmešano z raztopino, ki vsebuje natrij.
In the first study (P01522), which had a 3 month double-blind phase, 70 patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6 (35 patients in each group).
V prvi študiji (P01522), ki je vsebovala tudi 3 mesečno dvojno slepo fazo, je 70 bolnikov prejemalo bodisi infliksimab v odmerku 5 mg/kg bodisi placebo v 0., 2. in 6. tednu (po 35 bolnikov v vsaki skupini).
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after infliximab treatment.
Bolniki morajo biti obveščeni, naj pridejo k zdravniku, če se v času zdravljenja z infliksimabom ali po njem pojavijo znaki ali simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hujšanje ali nekoliko zvišana telesna temperatura).
In rheumatoid arthritis clinical studies, the incidence of serious infections including pneumonia was higher in infliximab plus methotrexate-treated patients compared with methotrexate alone especially at doses of 6 mg/kg or greater (see section 4.4).
V študijah revmatoidnega artritisa so se resne okužbe vključno s pljučnico pojavile pogosteje pri bolnikih zdravljenih z infliksimabom skupaj z metotreksatom, če jih primerjamo s tistimi, zdravljenimi samo z metotreksatom posebno pri odmerkih 6 mg/kg ali višjih (glejte poglavje 4.4).
How much Remsima is given
Koliko zdravila Remsima uporabiti
If serious reactions occur, symptomatic treatment must be given and further infliximab must not be administered (see section 4.8).
Če se pojavijo resne reakcije, morate uvesti simptomatično zdravljenje in bolniku ne smete več dajati infliksimaba (glejte poglavje 4.8).
Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
meningitis, oportunistične okužbe (npr. invazivne glivične okužbe [pnevmocistoza, histoplazmoza, aspergiloza, kokcidioidomikoza, kriptokokoza, blastomikoza], bakterijske okužbe [okužbe z atipičnimi mikobakterijami, listerioza,
Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4).
Občasno poročajo o pojavu lupusa in lupusu podobnih sindromov (glejte poglavje 4.4).
In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
1. skupina je prejemala 5 mg/kg infliksimaba, v 2. skupini pa so od infuzije v 36. tednu vsi bolniki, ki so imeli BASDAI ≥ 3 pri 2 zaporednih obiskih, prejemali po 7,5 mg/kg infliksimaba na vsakih 6. tednov, do 96. tedna.
• Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
• znaki okužbe (vključno s TBC), na primer zvišana telesna temperatura, občutek utrujenosti, kašelj, ki je lahko trdovraten, kratka sapa, gripi podobni simptomi, hujšanje, nočno potenje, driska, rane, nabiranje ognojkov v črevesju ali okoli anusa (absces), težave z zobmi ali pekoč občutek med uriniranjem.
In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients receiving infliximab without progression to severe hepatic injury.
V kliničnih preskušanjih so opazili blago do zmerno zvišanje vrednosti ALT in AST pri bolnikih, ki so prejemali infliksimab, brez napredovanja motnje do hude jetrne poškodbe.
Intravenous formulation
intravenska uporaba
Infliximab Maintenance 10 mg/kg (n=112) (p value)
Vzdrževalno zdravljenje z infliksimabom 10 mg/kg (n=112) (p vrednost)