FrancophonIA/ELRC3.0 huggingface dataset:
English: 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, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Slovenian: Med najresnejše, z uporabo zaviralcev 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, demielinizirajoče bolezni, dogodki povezani z jetri ali žolčnikom, limfom, hepatosplenični limfom celic T (HSTCL), levkemija, karcinom Merklovih celic, melanom, pojav malignomov pri otrocih, sarkoidoza/sarkoidozi podobne reakcije, črevesni ali perianalni absces (pri Crohnovi bolezni) ter resne z infuzijo povezane reakcije (glejte poglavje 4.4).
English: In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Slovenian: V kliničnih študijah z uporabo enega ali več odmerkov infliksimaba od 1 do 20 mg/kg so protitelesa proti infliksimabu našli pri 14 % bolnikov zdravljenih s katerim od zdravil za zaviranje imunske odzivnosti ter pri 24 % bolnikov, ki niso prejemali tovrstnih zdravil.
English: Patients should be closely monitored and infliximab must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Slovenian: Zdravljenja z infliksimabom ne smete nadaljevati pri bolnikih, pri katerih se pojavijo ali poslabšajo simptomi srčnega popuščanja (glejte poglavji 4.3 in 4.8).
English: In clinical studies 36% of infliximab-treated patients were treated for infections compared with 25% of placebo-treated patients.
Slovenian: V kliničnih študijah je bilo 36 % bolnikov, zdravljenih z infliksimabom, zdravljenih tudi zaradi okužbe, v primerjavi s 25 % tistih, ki so prejemali placebo.
English: Inflectra contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo Inflectra vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni "brez natrija".
English: Sustained response (clinical response at both week 8 and week 30)a
Slovenian: Trajnejši odziv (klinični odziv tako v 8. tednu kot v
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment or after dose adjustment.
Slovenian: O nadaljevanju terapije pa temeljito premislite pri bolnikih, ki v prvih 12 tednih zdravljenja ali po prilagoditvi odmerka ne kažejo nobenih znakov, da jim zdravljenje koristi.
English: Eighty-nine percent (50/56) of patients who lost clinical response on infliximab 5 mg/kg maintenance therapy after week 14 responded to treatment with infliximab 10 mg/kg.
Slovenian: Kar 89 % (50/56) bolnikov, pri katerih je klinični odziv izzvenel ob vzdrževalnem zdravljenju z infliksimabom v odmerku 5 mg/kg po 14. tednu, se je odzvalo na zdravljenje z infliksimabom v odmerku 10 mg/kg.
English: • Tell your doctor before you are given Inflectra if you are a carrier of hepatitis B or have ever had it.
Slovenian: • Preden prejmete zdravilo Inflectra, povejte svojemu zdravniku, če ste prenašalec hepatitisa B ali ste kdaj imeli ta virus.
English: When starting a new card, please keep this card as a reference for 4 months after your last dose of Inflectra.
Slovenian: Ko prejmete novo kartico, imejte to kartico pri sebi še 4 mesece po zadnjem odmerku zdravila Inflectra.
English: The required volume of reconstituted Inflectra solution should slowly be added to the 250-mL infusion bottle or bag and gently be mixed.
Slovenian: Potrebni volumen rekonstituirane raztopine zdravila Inflectra morate počasi dodajati v 250-ml infuzijske steklenice ali vrečke in rahlo premešati.
English: Therefore, the combination of infliximab and anakinra is not recommended.
Slovenian: Kombiniranje infliksimaba in anakinre torej ni priporočljivo.
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Inflectra use before your baby is given any vaccine.
Slovenian: • Pomembno je, da zdravniku vašega dojenčka in drugim zdravstvenim delavcem poveste, da ste prejemali zdravilo Inflectra, še preden dojenček dobi katerokoli cepivo.
English: The required total volume of reconstituted Inflectra solution has to be calculated.
Slovenian: Izračunati morate celoten volumen potrebne rekonstituirane raztopine zdravila Inflectra.
English: For volumes greater than 250 mL, either use a larger infusion bag (e.g. 500 mL, 1000 mL) or use multiple 250 mL infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/mL.
Slovenian: Da zagotovite, da koncentracija infuzijske raztopine ne preseže 4 mg/ml, za volumne, večje od 250 ml, uporabite večjo infuzijsko vrečko (npr. 500 ml, 1.000 ml) ali uporabite več 250-mililitrskih infuzijskih vrečk.
English: 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.
Slovenian: Začetno zdravljenje pri aktivni Crohnovi bolezni s fistulami 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.
English: • If you received Inflectra during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: • Če ste v času nosečnosti prejemali zdravilo Inflectra, lahko pri vašem dojenčku obstaja povečano tveganje za okužbe.
English: 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).
Slovenian: 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).
English: However, before Inflectra is given to you, it is mixed with a solution that contains sodium.
Slovenian: Kljub temu bodo zdravilo Inflectra, preden ga boste prejeli, zmešali z raztopino, ki vsebuje natrij.
English: • you have heart failure that is moderate or severe.
Slovenian: • če imate zmerno ali hudo srčno popuščanje.
English: • Some patients receiving infliximab have developed serious liver problems.
Slovenian: • Pri nekaterih bolnikih, ki so prejemali infliksimab, so se pojavile hude težave z jetri.
English: Side effects may also occur after your treatment with Inflectra has stopped.
Slovenian: Neželeni učinki se lahko pojavijo tudi po koncu zdravljenja z zdravilom Inflectra.
English: The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Slovenian: Varnost in učinkovitost infliksimaba so ocenili v multicentrični, randomizirani, odprti, klinični študiji vzporednih skupin (C0168T72) pri 60 pediatričnih bolnikih, starih od 6 do 17 let (mediana starost 14,5 let), 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.
English: 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).
Slovenian: V 16. tednu je 47 bolnikov na placebu z < 10 % izboljšanjem stanja glede na začetek študije - tako glede števila oteklih kot bolečih sklepovprešlo na uvedbo infliksimaba (zgodnji umik).
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Inflectra.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom ali farmacevtom, preden boste prejeli zdravilo Inflectra.
English: If serious reactions occur, symptomatic treatment must be given and further infliximab infusions must not be administered (see section 4.8).
Slovenian: Če se pojavijo resne reakcije, morate uvesti simptomatično zdravljenje in bolniku ne smete več dajati infuzij infliksimaba (glejte poglavje 4.8).
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Slovenian: Če ste uporabili večji odmerek zdravila Inflectra, kot bi smeli Ker boste zdravilo prejeli od zdravnika ali medicinske sestre, je zelo malo verjetno, da ga boste prejeli preveč.
English: Warnings and precautions Talk to your doctor before or during treatment with Inflectra if you have:
Slovenian: Opozorila in previdnostni ukrepi Pred ali med zdravljenjem z zdravilom Inflectra se v naslednjih primerih posvetujte z zdravnikom:
English: • Tell your doctor if you are going to have any operations or dental procedures.
Slovenian: • Obvestite svojega zdravnika, če je pri vas načrtovan kirurški ali zobozdravstveni poseg.
English: The incidence of serious infections in infliximab-treated patients 65 years and older was greater than in those under 65 years of age.
Slovenian: Pri bolnikih, zdravljenih z infliksimabom, ki so bili stari 65 let ali več, je bila incidenca resnih okužb večja kot pri bolnikih, ki so bili mlajši od 65 let.
English: If active tuberculosis is diagnosed, infliximab therapy must not be initiated (see section 4.3).
Slovenian: Če postavite diagnozo aktivne tuberkuloze, ne smete uvesti zdravljenja z infliksimabom (glejte poglavje 4.3).
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebo-controlled, dose-response study.
Slovenian: Začetno zdravljenje pri zmerno do močno aktivni Crohnovi bolezni Učinkovitost infliksimaba v enkratnem odmerku so ocenjevali pri 108 bolnikih z aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 ≤ 400) v randomizirani, dvojno slepi, s placebom kontrolirani študiji odziva na različne odmerke zdravila.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Slovenian: okužba po cepljenju (po in utero izpostavitvi infliksimabu)* Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) redki:
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Slovenian: Zdravljenje z infliksimabom je bilo povezano z akutnimi infuzijskimi reakcijami, vključno z anafilaktičnim šokom in poznimi preobčutljivostnimi reakcijami (glejte poglavje 4.8).
English: Ask your doctor to record the type and date of your last screening(s) for TB on the card.
Slovenian: Zdravnik naj zabeleži vrsto in datume zadnjih presejalnih testov za TBC na opozorilno kartico.
English: In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p<0.001).
Slovenian: V študiji SPIRIT je bil delež bolnikov, ki so v 10. tednu dosegli PASI 75, 71,7 % v skupini, ki je prejemala 3 mg/kg infliksimaba, 87,9 % v skupini, ki je prejemala 5 mg/kg infliksimaba, in 5,9 % v skupini, ki je prejemala placebo (p < 0,001).
English: • Collection of blood outside the blood vessels (haematoma) or bruising
Slovenian: • nabiranje krvi izven krvnih žil (hematom) ali nastajanje podplutb
English: Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB.
Slovenian: Pri bolnikih, že zdravljenih z infliksimabom, so poročali o primerih tuberkuloze, tudi pri bolnikih, ki so bili zdravljeni z zdravili proti TBC.
English: • The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Inflectra over 1 hour.
Slovenian: • Zdravilo vam bodo dali v obliki 2-urne infuzije (kapalne infuzije) v eno od ven, običajno v roki.
English: Upon removal from refrigerated storage, Inflectra must not be returned to refrigerated storage.
Slovenian: Ko zdravilo Inflectra enkrat vzamete iz hladilnika, ga ne smete vrniti nazaj v hladilnik.
English: In patients treated with infliximab, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Slovenian: Če se pri bolnikih, zdravljenih z infliksimabom, razvije resna sistemska bolezen, je treba posumiti na invazivno glivično okužbo, kot so aspergiloza, kandidiaza, pnevmocistoza, histoplazmoza, kokcidioidomikoza ali blastomikoza, poleg tega pa je pri teh bolnikih že zgodaj v poteku preiskav potreben posvet z zdravnikom, ki ima strokovno znanje iz diagnostike in zdravljenja invazivnih glivičnih okužb.
English: Infliximab Maintenance 5 mg/kg (n=113) (p value)
Slovenian: Vzdrževalno zdravljenje z infliksimabom 5 mg/kg (n = 113) (p vrednost)
English: Infliximab Maintenance (5 mg/kg) (n=96)
Slovenian: Vzdrževalno zdravljenje z infliksimabom (5 mg/kg) (n = 96)
English: Before treatment with Inflectra
Slovenian: Pred zdravljenjem z zdravilom Inflectra
English: • You should receive recommended vaccinations before starting Inflectra treatment.
Slovenian: • Vsa priporočena cepljenja morate prejeti pred začetkom zdravljenja z zdravilom Inflectra.
English: Apathy.
Slovenian: Apatija
English: In this situation, infliximab should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Slovenian: V tem primeru bolniku najprej ponovno uvedite infliksimab v enkratnem odmerku, pozneje pa mu spet predpišite vzdrževalni odmerek zdravila v skladu s priporočili, ki so podana zgoraj.
English: The infusion solution has to be administered over a period of not less than the infusion time recommended (see section 4.2).
Slovenian: Infuzijsko raztopino morate bolniku infundirati v času, ki naj ne bo krajši od priporočenega trajanja infuzije (glejte poglavje 4.2).
English: ≥ 75% improvement a
Slovenian: ≥ 75 % izboljšanje
English: • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Slovenian: • znaki težav z jetri (vključno z okužbo s hepatitisom B, če ste ga že preboleli v preteklosti), na primer porumenelost kože ali oči, temno rjavo obarvan urin, bolečina ali oteklina na zgornji desni strani želodčnega predela, bolečinav sklepih, kožni izpuščaji ali zvišana telesna temperatura;
English: N ≥ 90% improvement a
Slovenian: ≥ 90 % izboljšanje
English: General disorders and administration site conditions Very common:
Slovenian: Vaginitis Splošne težave in spremembe na mestu aplikacije zelo pogosti:
English: Date of Inflectra therapy initiation:
Slovenian: Datum začetka zdravljenja z zdravilom Inflectra:
English: If there are any changes in your skin or growths on the skin during or after therapy, tell your doctor.
Slovenian: Povejte svojemu zdravniku v primeru kakršnekoli spremembe kože ali bule na koži med ali po zdravljenju.
English: 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.
Slovenian: Terapevtska uporaba povzročiteljev okužb, kot so žive oslabljene bakterije (npr. instilacija BCG v sečni mehur za zdravljenje raka), lahko povzroči klinične okužbe, vključno z razsejanimi okužbami, zato priporočamo, da jih ne dajete sočasno z infliksimabom.
English: Inflectra may be stored at temperatures up to a maximum of 25 °C for a single period of up to 6 months, but not exceeding the original expiry date.
Slovenian: Zdravilo Inflectra se lahko shranjuje pri temperaturah do največ 25 °C za enkratno obdobje do 6 mesecev, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
English: In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
Slovenian: V kontroliranih delih kliničnih študij zaviralcev TNF so med bolniki, ki so prejemali zaviralec TNF opažali več primerov rakavih bolezni, vključno z limfomom, kot pri kontrolni skupini.
English: Mean ± SD
Slovenian: Srednja vrednost ± SD
English: Inflectra will generally be stored by the health professionals at the hospital or clinic.
Slovenian: Zdravnik ali drugi zdravstveni delavci bodo poskrbeli za shranjevanje zdravila Inflectra v bolnišnicah ali klinikah.
English: 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).
Slovenian: V 24. tednu je število bolnikov z odzivom ASAS 20 znašalo 15 od 78 (19 %) v skupini za placebo in 123 od 201 (61 %) v skupini, ki je prejemala infliksimab v odmerku 5 mg/kg (p < 0,001).
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Inflectra treatment.
Slovenian: • Pri bolnikih s KOPB in tistih, ki veliko kadijo, lahko obstaja povečano tveganje za nastanek raka pri zdravljenju z zdravilom Inflectra.
English: Patients treated with Inflectra should be given the patient reminder card.
Slovenian: Bolniki, ki se zdravijo z zdravilom Inflectra, morajo prejeti opozorilno kartico za bolnika.
English: The infusion solution has to be administered over a period of not less than the infusion time recommended (see section 3).
Slovenian: Infuzijsko raztopino morate bolniku infundirati v času, ki naj ne bo krajši od priporočenega trajanja infuzije (glejte poglavje 3).
English: For results see Table 6.
Slovenian: Rezultati študije so podani v Preglednici 6.
English: • Do not breast-feed when you are being treated with Inflectra or for 6 months after your last treatment with Inflectra.
Slovenian: • Med zdravljenjem z zdravilom Inflectra in še 6 mesecev po zadnjem zdravljenju ne smete dojiti.
English: Week 54 Clinical Response a
Slovenian: 54. teden Klinični odziv
English: • Tell your doctor before you are given Inflectra if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Slovenian: • Preden se začnete zdraviti z zdravilom Inflectra, povejte svojemu zdravniku, če imate kronično obstruktivno pljučno bolezen (KOPB) ali veliko kadite.
English: Signs include yellowing of the skin and eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Slovenian: Znaki vključujejo porumenelost kože in oči, temno rjavo obarvan urin, bolečino ali oteklino na zgornji desni strani želodčnega predela, bolečino v sklepih, kožne izpuščaje ali zvišano telesna temperaturo.
English: Caution should be exercised when considering the use of infliximab in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Slovenian: Pri odločanju o uporabi infliksimaba pri bolnikih s kroničnimi okužbami ali ponavljajočimi se okužbami v pretekli anamnezi, pa tudi pri tistih, s sočasno imunosupresivno terapijo, je potrebna previdnost.
English: If these medicines do not work well enough, you will be given Inflectra to treat your disease.
Slovenian: Če ta zdravila ne bodo dovolj dobro delovala, boste prejeli zdravilo Inflectra za zdravljenje vaše bolezni.
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p <0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Slovenian: V (združeni) skupini, ki se je zdravila z infliksimabom, so pri večjem odstotku bolnikov lahko ukinili kortikosteroide ob ohranjeni klinični remisiji kot pri skupini, ki je prejemala placebo, kar velja tako za 30. teden (22,3 % v primerjavi s 7,2 %, p < 0,001, združeni podatki iz preskušanj ACT 1 in ACT 2) kot za 54. teden (21,0 % v primerjavi z 8,9 %, p = 0,022, podatki iz preskušanja ACT 1).
English: Infliximab Maintenance 10 mg/kg (n=112) (p value)
Slovenian: Vzdrževalno zdravljenje z infliksimabom 10 mg/kg (n = 112) (p vrednost)
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils
Slovenian: • ostale težave s kožo, kot so multiformni eritem, mehurčki na koži in luščenje kože ali kožne težave ali turi (furunkuloza)
English: 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.
Slovenian: Vsem bolnikom morate naročiti, 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).
English: In phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Slovenian: V kliničnih študijah faze III se je pri 18 % bolnikov, zdravljenih z infliksimabom, med infundiranjem pojavila z infuzijo povezana reakcija, v primerjavi s 5 % bolnikov, ki so prejemali placebo.
English: Inflectra 100 mg powder for concentrate for solution for infusion
Slovenian: Inflectra 100 mg prašek za koncentrat za raztopino za infundiranje
English: If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with infliximab should be given.
Slovenian: Če bolnik ne pokaže nobenega odziva po 14 tednih (tj. po 4 odmerkih), ga ne smete več zdraviti z infliksimabom.
English: • You will be monitored while you are given Inflectra and also for 1 to 2 hours afterwards.
Slovenian: • Med prejemanjem zdravila Inflectra in še eno do dve uri potem vas bodo spremljali.
English: During treatment with Inflectra
Slovenian: Med zdravljenjem z zdravilom Inflectra
English: Concurrent use of stable doses of oral corticosteroids (≤10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
Slovenian: Sočasna uporaba stalnih odmerkov peroralnih kortikosteroidov (≤ 10 mg/dan) in/ali NSAID je bila dovoljena,
English: Inflectra should be administered intravenously.
Slovenian: Zdravilo Inflectra je treba dajati intravensko.