FrancophonIA/ELRC3.0 huggingface dataset:
English: In the paediatric Crohn's disease study, 17.5% of randomised patients experienced 1 or more infusion reactions.
Slovenian: V pediatrični študiji Chronove bolezni se je pri 17,5 % naključno razvrščenih bolnikov pojavila ena oziroma več z infuzijo povezanih reakcij.
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFß).
Slovenian: Infliksimab je himerno človeško-glodalsko monoklonsko protitelo, ki se z veliko afiniteto veže tako na topne kot na transmembranske oblike TNFα, ne pa tudi na limfotoksin α (TNFß).
English: The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
Slovenian: Varnosti in učinkovitosti infliksimaba pri otrocih s Crohnovo boleznijo, mlajših od 6 let, niso preučevali.
English: How to use Zessly Rheumatoid arthritis
Slovenian: Kako uporabljati zdravilo Zessly Revmatoidni artritis
English: In this situation, Zessly should be reinitiated as a single dose followed by the maintenance dose recommendations described above.
Slovenian: V tem primeru bolniku najprej ponovno uvedite zdravilo Zessly v enkratnem odmerku, pozneje pa mu spet predpišite vzdrževalni odmerek zdravila v skladu s priporočili, ki so podana zgoraj.
English: Zessly is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Vendar pa je zdravilo Zessly razredčeno z raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
English: Cases of agranulocytosis have also been reported (see section
Slovenian: Poročali so tudi o primerih agranulocitoze (glejte poglavje 4.8).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Zessly Vsebina pakiranja in dodatne informacije
English: It is important that you tell your baby's doctors and other healthcare professionals about your Zessly use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Slovenian: Zessly, da bodo lahko presodili, kdaj sme vaš dojenček prejeti katero koli cepivo, vključno z živimi cepivi, kot je cepivo BCG (uporablja se za preprečevanje tuberkuloze).
English: Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Slovenian: transverzni mielitis, demielinizirajoče bolezni osrednjega živčevja (bolezen, podobna multipli sklerozi, in optični nevritis), periferne demielinizirajoče bolezni (na primer Guillain-Barréjev sindrom, kronična vnetna demielinizirajoča polinevropatija in multifokalna motorična nevropatija)
English: In the paediatric ulcerative colitis trial, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Slovenian: V preskušanju pri pediatričnih bolnikih z ulceroznim kolitisom so bili najpogostejši neželeni učinki okužba zgornjih dihal, faringitis, bolečine v trebuhu, zvišana telesna temperatura in glavobol.
English: Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Slovenian: Uporabite lahko le infuzijske komplete, opremljene z linijskim, sterilnim, apirogenim filtrom, ki le malo veže beljakovine (velikost por 1,2 mikrometra ali manj).
English: • Talk to you doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Slovenian: Povzročitelji okužb v terapevtske namene • Obvestite zdravnika, če ste pred kratkim prejeli ali boste prejeli povzročitelje okužb v terapevtske namene (kot je uporaba BCG za zdravljenje raka).
English: There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab.
Slovenian: Iz obdobja trženja obstajajo poročila o poslabševanju srčnega popuščanja pri bolnikih, ki so jemali infliksimab, z ali brez ugotovljivih dejavnikov, ki bi lahko poslabšali stanje.
English: Data to support dose titration in rheumatoid arthritis come from study 1, study 2 and study 3.
Slovenian: Podatki, ki govorijo v prid titraciji odmerka pri revmatoidnem artritisu, izvirajo iz študije 1,
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Zessly.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom, preden boste prejeli zdravilo Zessly.
English: Table 5 Effects on response and remission rate in patients with moderately to severely active Crohn's disease, data from study 4 (week-2 responders)
Slovenian: Učinki na stopnjo odziva in ponovitev bolezni pri bolnikih z zmerno do hudo aktivno Crohnovo boleznijo; podatki iz študije 4 (bolniki z odzivom v 2. tednu)
English: AZA Monotherapy infliximab Monotherapy infliximab + AZA Combination Therapy
Slovenian: AZA v monoterapiji infliksimab v monoterapiji infliksimab + AZA v kombinirani terapiji
English: • Some children and teenage patients who have received TNF-blockers such as infliximab have developed cancers, including unusual types, which sometimes resulted in death.
Slovenian: Poleg tega še: • Pri nekaterih otrocih in najstnikih, ki so prejemali zaviralce TNF, kot je zdravilo Zessly, se je razvil rak, vključno z zelo neobičajnimi oblikami, ki se včasih končajo s smrtnim izidom.
English: In a subset of 90 adult patients with rheumatoid arthritis from the study 2 a similar proportion of patients in each treatment group (methotrexateplus: placebo [n=17], 3mg/kg [n=27] or 6mg/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.
Slovenian: V podskupini 90 odraslih bolnikov z revmatoidnim artritisom iz študije 2 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 v odmerku 3 mg/kg [n = 27] ali infliksimab v odmerku 6 mg/kg [n = 46]), kar kaže, da infliksimab ni motil od celic T neodvisnih humoralnih imunskih odgovorov.
English: Zessly is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Slovenian: Psoriatični artritis Zdravilo Zessly je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih bolnikih v primeru nezadostnega odziva na predhodno zdravljenje s protirevmatičnimi zdravili DMARD.
English: Periodic screening should continue in women treated with Zessly, including those over 60 years of age.
Slovenian: Pri ženskah, zdravljenih z zdravilom Zessly, vključno s starejšimi od 60 let, je treba nadaljevati s periodičnimi presejalnimi testi.
English: • You will be monitored while you are given Zessly and also for 1 to 2 hours afterwards.
Slovenian: • Med prejemanjem zdravila Zessly in še eno do dve uri po tem vas bodo spremljali.
English: • Tell your doctor before you are given Zessly if you have an infection, even if it is a very minor one.
Slovenian: • Preden prejmete zdravilo Zessly, povejte zdravniku, če imate okužbo, tudi če je zelo blaga.
English: In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximabtreated patients compared with control patients.
Slovenian: V poskusnem kliničnem preskušanju za ovrednotenje uporabe infliksimaba pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB) so poročali o večjem številu malignomov pri bolnikih, zdravljenih z infliksimabom, kot pri tistih iz kontrolne skupine.
English: • If you received Zessly 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.
Slovenian: • Če ste zdravilo Zessly prejemali v času nosečnosti, lahko tudi pri vašem dojenčku še šest mesecev po rojstvu obstaja večje tveganje za okužbo z živimi cepivi.
English: Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentrationtime curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steady-state drug exposure in adults.
Slovenian: Pri uporabi infliksimaba 5 mg/kg vsakih 8 tednov je bila napovedana mediana izpostavljenosti infliksimabu v stanju dinamičnega ravnovesja (površina pod krivuljo koncentracija-čas v stanju dinamičnega ravnovesja, AUCss) pri pediatričnih bolnikih, starih od 6 let do 17 let, približno 20 % nižja od napovedane madiane izpostavljenosti zdravilu v stanju dinamičnega ravnovesja pri odraslih.
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section 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).
Slovenian: 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).
English: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Slovenian: novo nastala in poslabšana psoriaza, vključno s pustulozno psoriazo (predvsem na dlaneh in podplatih), urtikarija, izpuščaj, pruritus, hiperhidroza, suha koža, glivični dermatitis, ekcem, alopecija občasni:
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study 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.
Slovenian: 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 bliko 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.
English: Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p < 0.001).
Slovenian: Zdravljenje z infliksimabom je zmanjšalo hitrost napredovanja okvare perifernih sklepov v primerjavi s placebom v 24. tednu kot primarni končni rezultat, merjeno kot sprememba celotne vrednosti modificiranega rezultata vdH-S glede na stanje na začetku študije (v skupini za placebo je znašala srednja vrednost ± SD 0,82 ± 2,62, v primerjavi z
English: Crohn's disease (6 to 17 years)
Slovenian: Crohnova bolezen (pri bolnikih, starih od 6 do 17 let)
English: In the second clinical study, (study 9), 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.
Slovenian: V drugi klinični študiji (študija 9) 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.
English: • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given
Slovenian: • Obvestite zdravnika, če imate na koži nenormalne odprtine (fistule), preden začnete prejemati zdravilo Zessly.
English: Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54.
Slovenian: Med bolniki, zdravljenimi z infliksimabom, ki so imeli z infuzijo povezano reakcijo v času uvajalne faze zdravljenja do 6. tedna, je v času vzdrževalnega zdravljenja, to je od 7. do 54. tedna, z infuzijo povezano reakcijo imelo 27 %
English: Indication Number of patients
Slovenian: Število randomiziranih bolnikov
English: infliximab Maintenance (5 mg/kg) (n = 96)
Slovenian: Vzdrževalno zdravljenje z infliksimabom (5 mg/kg) (n = 96)
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C - 8°C for 24 hours.
Slovenian: Vendar, če je bila raztopina pripravljena v aseptičnih pogojih, jo lahko za 24 ur shranite v hladilniku pri temperaturi 2 °C-8 °C.
English: Zessly is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Slovenian: Ankilozirajoči spondilitis Zdravilo Zessly je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih bolnikih, ki so se nezadostno odzvali na konvencionalno terapijo.
English: If you were using Zessly during pregnancy, tell your baby's doctor and other health care professionals caring for your baby about your Zessly use before the baby receives any vaccines.
Slovenian: Če ste prejemali zdravilo Zessly med nosečnostjo, je pomembno, da o tem obvestite otrokovega zdravnika in druge zdravstvene delavce, ki skrbijo za vašega dojenčka, preden vaš dojenček prejme katero koli cepivo.
English: Paediatric Crohn's disease (6 to 17 years)
Slovenian: Crohnova bolezen pri pediatričnih bolnikih (6 do 17 let)
English: In study 12 in patients with plaque psoriasis, 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 12 pri bolnikih s psoriazo v plakih 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: • Fluid around the lungs (pleural effusion)
Slovenian: • tekočina okrog pljuč (plevralni izliv)
English: In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Slovenian: Pri spremljanju zdravila v obdobju trženja so poročali o primerih levkemije pri bolnikih, zdravljenjih z antagonisti TNF.
English: Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients.
Slovenian: Najpogostejši neželeni učinek zdravila, o katerem so poročali v kliničnih preskušanjih, je bila okužba zgornjih dihal, ki se je pojavila pri 25,3 % bolnikov, zdravljenih z infliksimabom, in pri 16,5 %
English: Fistula Response (%) a Complete fistula response (%) b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Slovenian: Odziv fistule (%) a Popoln odziv fistule (%) b a Zmanjšanje števila fistul z izcedkom za ≥ 50 % glede na stanje na začetku študije v obdobju ≥ 4 tednov b Bolnik nima nobenih fistul z izcedkom
English: If these medicines do not work well enough, you will be given Zessly to:
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Zessly za:
English: Patients on infliximab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6).
Slovenian: Pediatrični bolniki, ki prejemajo infliksimab, lahko sočasno prejmejo cepiva, razen živih cepiv (glejte poglavji 4.5 in 4.6).
English: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2)
Slovenian: PGA brez plakov (0) ali minimalni (1) PGA brez plakov (0), minimalni (1), ali blagi (2)
English: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis.
Slovenian: perforacija črevesja, stenoza črevesja, divertikulitis, pankreatitis,
English: In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus < 1% (1/222) on maintenance therapy.
Slovenian: V kraku za ponovno zdravljenje so imeli 4 % bolnikov (8/219) resno z infuzijo povezano reakcijo, v primerjavi z < 1 %
English: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Zessly can be re-administered within 16 weeks following the last infusion.
Slovenian: Če se znaki in simptomi bolezni ponovijo, lahko zdravilo Zessly ponovno uporabite v roku 16 tednov po zadnji infuziji.
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Zessly therapy.
Slovenian: Pri bolnikih z obstoječo ali nedavno nastalo demielinizirajočo boleznijo morate pred uvedbo terapije z zdravilom Zessly skrbno pretehtati razmerje med tveganji in koristmi anti-TNF zdravljenja za bolnika.
English: Zessly should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Srčno popuščanje Zdravilo Zessly morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II po
English: infliximab Maintenance 5 mg/kg (n = 113) (p value)
Slovenian: Vzdrževalno zdravljenje z infliksimabom 5 mg/kg (n = 113) (p vrednost)
English: The overall incidence of infections in the paediatric ulcerative colitis trial was 13/22 (59%) in the every 8 week maintenance treatment group and 14/23 (60.9%) in the every 12 week maintenance treatment group.
Slovenian: Celotna incidenca okužb v preskušanju pri pediatričnih bolnikih z ulceroznim kolitisom je bila 13/22 (59 %) v skupini, ki je dobivala vzdrževalno zdravljenje na 8 tednov, in 14/23 (60,9 %) v skupini, ki je dobivala vzdrževalno zdravljenje na 12 tednov.
English: Zessly infliximab
Slovenian: Placebo infliksimab
English: Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for
Slovenian: zdravljenih z infliksimabom, so poročali o primerih tuberkuloze, tudi pri bolnikih, ki so že bili zdravljeni z zdravili proti TBC.
English: Package leaflet: Information for the user Zessly 100 mg powder for concentrate for solution for infusion infliximab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Zessly 100 mg prašek za koncentrat za raztopino za infundiranje infliksimab (infliksimabum) Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: • More children taking infliximab developed infections as compared to adults.
Slovenian: • V primerjavi z odraslimi so se pri otrocih, ki so uporabljali infliksimab, pogosteje pojavile okužbe.
English: It is recommended that therapeutic infectious agents not be given concurrently with Zessly.
Slovenian: Priporočamo, da povzročiteljev okužb v terapevtske namene ne dajete sočasno z zdravilom Zessly
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 trebuha, bolečino v sklepih, kožne izpuščaje ali zvišano telesno temperaturo.
English: If these medicines do not work well enough, you will be given Zessly to treat your disease.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Zessly za zdravljenje vaše bolezni.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies.
Slovenian: Učinkovitost infliksimaba so ocenjevali v dveh multicentričnih, randomiziranih, dvojno slepih osrednjih preskušanjih.
English: • Reduce the signs and symptoms of your disease
Slovenian: • zmanjšanje znakov in simptomov bolezni, • izboljšanje gibljivosti.
English: • Collection of blood outside the blood vessels (haematoma) or bruising
Slovenian: • kopičenje krvi zunaj krvnih žil (hematom) ali nastajanje podplutb
English: The safety and efficacy of infliximab were assessed in two (studies 6 and 7) randomised, doubleblind, 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)].
Slovenian: Varnost in učinkovitost infliksimaba so ocenili v dveh randomiziranih, dvojno slepih in s placebom kontroliranih kliničnih študijah (študiji 6 in 7) 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
English: Sustained Steroid-Free Remissionb a
Slovenian: Ohranjena remisija brez jemanja steroidovb a
English: During treatment with Zessly
Slovenian: Med zdravljenjem z zdravilom Zessly
English: Concurrent administration of TNF-alpha inhibitor and anakinra
Slovenian: Sočasno zdravljenje z zaviralcem TNFα in anakinro
English: Study 3 was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
Slovenian: Študija 3 je bila randomizirana, multicentrična, dvojno slepa študija varnosti zdravila pri vzporednih skupinah in je imela tri krake.
English: 4 years at 2°C - 8°C.
Slovenian: Pred rekonstitucijo: 4 leta pri temperaturi 2 °C - 8 °C
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 Zessly treatment.
Slovenian: Vsem bolnikom morate naročiti, naj pridejo k zdravniku, če se v času zdravljenja z zdravilom Zessly ali po njem pojavijo znaki ali simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hujšanje ali nekoliko zvišana telesna temperatura).
English: Hypotension, hypertension, ecchymosis, hot flush, flushing.
Slovenian: hipotenzija, hipertenzija, ekhimoza, navali vročine, zardevanje občasni:
English: • Do not breast-feed when you are being treated with Zessly or for 6 months after your last treatment with Zessly.
Slovenian: • Med zdravljenjem z zdravilom Zessly in še 6 mesecev po zadnjem zdravljenju ne smete dojiti.
English: Repeated administration of infliximab (5 mg/kg at 0, 2, and 6 weeks in fistulising Crohn´'s disease, 3 or 10 mg/kg every 4 or 8 weeks in rheumatoid arthritis) resulted in a slight accumulation of infliximab in serum after the second dose.
Slovenian: Po večkratni uporabi infliksimaba (5 mg/kg na začetku, v 2. in 6. tednu pri Crohnovi bolezni s fistulami oz. 3 ali 10 mg/kg na vsake 4 ali 8 tednov pri revmatoidnem artritisu) so ugotavljali blago kopičenje zdravila v serumu po drugem odmerku.
English: Zessly and Kineret should not be used together.
Slovenian: Zdravili Zessly in Kineret se ne smeta uporabljati skupaj.