FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies with intravenous infliximab, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8).
Slovenian: V kliničnih študijah z intravenskim infliksimabom so bile pozne preobčutljivostne reakcije občasne in so se pojavile po premoru brez prejemanja infliksimaba manj kot 1 leto (glejte poglavji 4.4 in 4.8).
English: Overall, 8 (13.3%) of 60 treated patients experienced one or more infusion reactions, with 4 of 22 (18.2%) in the q8 week and 3 of 23 (13.0%) in the q12 week treatment maintenance group.
Slovenian: Skupaj se je ena ali več infuzijskih reakcij pojavilo pri 8 (13,3 %) od 60 zdravljenih bolnikov in sicer pri 4 od 22 (18,2 %) v skupini, ki je dobivala vzdrževalno zdravljenje na 8 tednov, in pri 3 od 23 (13,0 %) v skupini, ki je dobivala vzdrževalno zdravljenje na 12 tednov.
English: 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
English: Remsima is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Slovenian: Zdravilo Remsima je indicirano za zdravljenje hude, aktivne Crohnove bolezni pri otrocih in mladostnikih, starih od 6 do 17 let, ki se niso odzvali na običajno terapijo, vključno s kortikosteroidi, imunomodulatorji in primarno prehransko terapijo, ter pri tistih, ki ne prenašajo teh običajnih načinov zdravljenja oziroma imajo kontraindikacije zanje.
English: • Do not reuse the syringe.
Slovenian: • Injekcijske brizge ne smete ponovno uporabiti.
English: (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Slovenian: V okviru razvrstitve po organskih sistemih so neželeni učinki razvrščeni po naslednjih kategorijah pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki
English: Remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Slovenian: Zdravilo Remsima je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih bolnikih, ki se niso odzvali na druge sistemske terapije, na primer ciklosporin, metotreksat ali psoralen in obsevanje z ultravijolično svetlobo A (PUVA) (glejte poglavje 5.1), ali pa imajo kontraindikacijo zanje ali jih ne prenašajo.
English: • Do not breast-feed when you are being treated with Remsima or for 6 months after your last treatment with Remsima.
Slovenian: • Med zdravljenjem z zdravilom Remsima in še 6 mesecev po zadnjem zdravljenju ne smete dojiti.
English: Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.
Slovenian: priporočamo, da z dajanjem infuzije začnete čim prej, v roku 3 ur po rekonstituciji in redčenju.
English: • Do not use the syringe if it has been dropped or is visibly damaged.
Slovenian: • Injekcijske brizge ne smete uporabiti, če je padla na tla ali če ima vidne znake poškodb.
English: 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).
Slovenian: V 12. tednu je bilo število bolnikov z odzivom BASDAI 50 v skupini za placebo 3 od 35 (9 %), v skupini, ki je prejemala odmerek 5 mg/kg pa 20 od 35 (57 %) (p< 0,01).
English: Pack sizes of 1, 2, 3, 4, 5 vials.
Slovenian: Zdravilo Remsima je pakirano po 1, 2, 3, 4 ali 5 vial.
English: 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.
Slovenian: To naredite tako, da iz 250 ml steklenice ali infuzijske vrečke odvzamete tisti volumen 9 mg/ml (0,9 %) raztopine natrijevega klorida za infundiranje, ki ustreza volumnu rekonstituiranega zdravila Remsima.
English: • Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest.
Slovenian: • znaki težav s pljuči, na primer kašelj, težave z dihanjem ali stiskanje v prsih.
English: Change from baseline in total van der Heijde-modified Sharp scoreb Mean ± SDa
Slovenian: Sprememba z začetne vrednosti za skupni rezultat po metodi van der Heijde, modificirani po Sharpub Srednja vrednost ± SDa Mediana
English: • Tell your doctor before you are given Remsima if you are a carrier of hepatitis B or have ever had it.
Slovenian: • Preden prejmete zdravilo Remsima, povejte zdravniku, če ste prenašalec hepatitisa B ali če ste ga imeli kdaj v preteklosti.
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 zdravljenih z zaviralec TNF.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤18 years of age), including infliximab in the post-marketing setting.
Slovenian: Maligne in limfoproliferativne bolezni Pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF (z začetkom zdravljenja pri starosti ≤ 18 let), vključno z infliksimabom v obdobju trženja zdravila, so poročali o pojavu malignomov, od katerih so bili nekateri smrtni.
English: placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Slovenian: placeb o infliksima b placeb o infliksima b placeb o infliksima b placeb o infliksima b
English: The safety and efficacy of Remsima subcutaneous therapy in children aged below 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost terapije z zdravilom Remsima v subkutani obliki pri otrocih, mlajših od 18 let,
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p<0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Slovenian: Odstotki bolnikov z zacelitvijo sluznice v 26. tednu so bili statistično značilno večji v skupini, ki je prejemala kombinacijo infliksimaba in AZA (43,9 %, p< 0,001), in v skupini, ki je prejemala infliksimab v monoterapiji (30,1 %, p = 0,023), kot pa v skupini, ki je prejemala AZA v monoterapiji (16,5 %).
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: Ulcerozni kolitis pri pediatričnih bolnikih (od 6 do 17 let) 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: 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.
Slovenian: V kliničnih študijah z infliksimabom v intravenski obliki niso opazili nikakršnih večjih, s starostjo povezanih razlik v očistku ali porazdelitvenem volumnu, enako se predvideva za infliksimab v subkutani obliki.
English: Remsima is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Slovenian: Zdravilo Remsima je na voljo v steklenih vialah s praškom za koncentrat za raztopino za infundiranje.
English: c. Gently press a cotton ball or gauze over the injection site and apply an adhesive bandage, if necessary.
Slovenian: c. Kosem vate ali gazo nežno pritisnite na mesto injiciranja in ga po potrebi prelepite z obližem.
English: • Tell your doctor before you are using Remsima if you are a carrier of hepatitis B or have ever had it.
Slovenian: • Preden uporabite zdravilo Remsima, povejte zdravniku, če ste prenašalec hepatitisa B ali če ste ga imeli kdaj v preteklosti.
English: Week 22 137 (78.7%) 139 (84.2%) 90 (51.7%) 85 (51.5%) 49 (28.2%) 46 (27.9%)
Slovenian: 6. teden 103 (59,2 %) 107 (64,8 %) 45 (25,9 %) 47 (28,5 %) 18 (10,3 %) 19 (11,5 %) 22. teden 137 (78,7 %) 139 (84,2 %) 90 (51,7 %) 85 (51,5 %) 49 (28,2 %) 46 (27,9 %) 54. teden 125 (71,8 %)a 132 (80,0 %) 101 (58,0 %)a 108 (65,5 %) 68 (39,1 %)a 77 (46,7 %) a
English: Placebo Maintenance (n=99)
Slovenian: Vzdrževalno zdravljenje s placebom (n=110)
English: • 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).
Slovenian: • znaki motnje v delovanju imunskega sistema, na primer bolečina v sklepih ali izpuščaj na licih ali rokah, ki je občutljiv na sončno svetlobo (lupus), ali kašelj, kratka sapa, zvišana telesna temperatura ali kožni izpuščaj (sarkoidoza).
English: 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.
Slovenian: Sočasna uporaba imunomodulatorjev je bila povezana z zmanjšano incidenco protiteles na infliksimab in v primeru intravenskega dajanja infliksimaba tudi z zmanjšanjem pogostnosti z infuzijo povezanih reakcij.
English: Excipients: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate.
Slovenian: Pomožne snovi: saharoza, polisorbat 80, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat.
English: Circulatory failure, petechia, vasospasm Respiratory, thoracic and mediastinal disorders Very common
Slovenian: odpoved krvnega obtoka, petehija, vazospazem Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti:
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Remsima.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden boste prejeli zdravilo Remsima.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), lichenoid reactions, acute generalised exanthematous pustulosis (AGEP).
Slovenian: multiformni eritem, furunkuloza, linearna IgA bulozna dermatoza (LABD), lihenoidne reakcije, akutna generalizirana eksantematozna pustuloza (AGEP - acute generalised exanthematous pustulosis).
English: Keep the medicinal product in its outer carton in order to protect from light.
Slovenian: Zdravilo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Can be stored at room temperature (up to 25°C) for a single period up to 6 months, but not exceeding the original expiry date.
Slovenian: Lahko se shranjuje pri sobni temperaturi (do 25 °C) za enkratno obdobje do 6 mesecev, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
English: Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Slovenian: Med spontano poročanimi resnimi neželenimi učinki v obdobju trženja z uporabo infliksimaba iz obdobja trženja pri pediatričnih bolnikih so bili tudi malignomi, vključno s T-celičnimi limfomi jeter in vranice, prehodno nenormalnimi izvidi jetrnih encimov, lupusu podobnimi sindromi in pozitivnimi izvidi na avtoprotitelesa (glejte poglavji 4.4 in 4.8).
English: Finish the injection (see Figure G).
Slovenian: Končajte injiciranje (glejte sliko G).
English: • The abdomen except for the 5 cm around the belly button (navel).
Slovenian: • Trebuh, razen na področju, ki je od vašega popka oddaljeno manj kot 5 centimetrov.
English: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia
Slovenian: srčno popuščanje (novo nastalo ali poslabšanje), aritmija,
English: • upright and stable during use;
Slovenian: • je med uporabo v pokončnem in stabilnem položaju; • je odporen na iztekanje in
English: What you need to know before you use Remsima You must not use Remsima if
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Remsima Ne uporabljajte zdravila Remsima
English: Hepatic and renal impairment
Slovenian: Jetrna in ledvična bolezen
English: 178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Slovenian: so ugotovili hudo obliko bolezni (ocena CDAI > 300 in sočasna uporaba kortikosteroidov in /ali imunosupresivov), kar ustreza populaciji, opredeljeni v indikacijah (glejte poglavje 4.1).
English: The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess.
Slovenian: Najpogosteje prijavljene okužbe so bile okužbe zgornjih dihal in faringitis,
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
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils (furunculosis)
Slovenian: • ostale težave s kožo, kot so multiformni eritem, mehurji na koži in luščenje kože, ali turi (furunkuloza)
English: Hypotension, hypertension, ecchymosis, hot flush, flushing
Slovenian: hipotenzija, hipertenzija, ekhimoza, navali vročine, zardevanje občasni:
English: Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and a reduction in the frequency of infusion reactions.
Slovenian: Sočasna uporaba imunomodulatorjev je bila povezana z zmanjšano incidenco protiteles na infliksimab in zmanjšanjem pogostnosti z infuzijo povezanih reakcij.
English: However, studies from the published literature in various indications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggest that non-live vaccinations received during treatment with anti-TNF therapies, including infliximab may elicit a lower immune response than in patients not receiving anti-TNF therapy.
Slovenian: Vseeno pa študije iz objavljene literature za različne indikacije (npr. revmatoidni artritis, psoriaza, Crohnova bolezen) nakazujejo, da cepljenja z neživimi cepivi med prejemanjem anti
English: What you need to know before you use Remsima You must not be given Remsima if
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Remsima Zdravila Remsima ne smete dobivati
English: Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Slovenian: AZA ali 6-MP, bodisi sočasno z zaviralcem TNF ali neposredno pred uporabo zaviralca TNF.
English: • When starting a new card, keep this card as a reference for 4 months after your last dose of Remsima.
Slovenian: • Ko prejmete novo kartico, imejte to kartico pri sebi še 4 mesece po zadnjem odmerku zdravila Remsima.
English: Choose an injection site (see Figure C).
Slovenian: Izberite mesto injiciranja (glejte sliko C).
English: Remsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo Remsima je indicirano za zdravljenje zmerno do močno aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se nezadostno odzvali na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ter pri tistih, ki ne prenašajo takšnega zdravljenja ali imajo medicinske kontraindikacije zanj.
English: 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.
Slovenian: Potrebni volumen rekonstituirane raztopine zdravila Remsima razredčite do 250 ml z 9 mg/ml
English: Upper respiratory tract infection, sinusitis
Slovenian: okužba zgornjih dihal, sinusitis pogosti:
English: Maintenance treatment in fistulising active Crohn's disease The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (ACCENT II).
Slovenian: Učinkovitost večkratnih infuzij infliksimaba pri bolnikih s Crohnovo boleznijo s fistulami so raziskovali v enoletni klinični študiji (ACCENT II).
English: • Tell your doctor before you are given Remsima if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
Slovenian: Pljučna bolezen ali bolniki, ki veliko kadijo • Preden prejmete zdravilo Remsima, povejte zdravniku, če imate kronično obstruktivno pljučno bolezen (KOPB) ali če veliko kadite.
English: 3 Number of patients evaluated for ALT. 4 Median follow-up is based on patients treated.
Slovenian: 4 Mediana dolžine spremljanja bolnikov je bila določena samo z upoštevanjem zdravljenih bolnikov.
English: If you are not sure, talk to your doctor before you are given Remsima.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, preden začnete prejemati zdravilo Remsima.
English: Clinical Responsea
Slovenian: Klinični odziva Klinična remisija
English: It is recommended that the conduct of these tests should be recorded in the patient reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Slovenian: Zdravnike opozarjamo, da so izvidi tuberkulinskega kožnega testa lahko lažno negativni, še posebej pri bolnikih, ki so močno bolni ali imajo zmanjšan imunski odziv.
English: Rheumatoid arthritis1
Slovenian: Revmatoid ni artritis1
English: 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.
Slovenian: Sočasna uporaba metotreksata in drugih imunomodulatorjev pri bolnikih z revmatoidnim artritisom lahko zmanjša tvorbo protiteles proti infliksimabu in poveča koncentracijo infliksimaba v plazmi.
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 zdravilo Remsima v enkratnem odmerku, pozneje pa mu spet predpišite vzdrževalni odmerek zdravila v skladu s priporočili, ki so podana zgoraj.
English: Mucosal healing at Week 30a a p <0.001, for each infliximab treatment group vs. placebo.
Slovenian: Celjenje sluznice v 30. tednua a p < 0,001 za vsako skupino, ki se je zdravila z infliksimabom, v primerjavi s placebom
English: If these medicines do not work well enough, you will be given Remsima which you will take with another medicine called methotrexate to:
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Remsima skupaj z zdravilom metotreksat za:
English: a. After the needle is inserted, let go of the pinched skin.
Slovenian: a. Ko vstavite iglo, spustite kožo, ki jo držite.
English: Remove the pen from the injection site.
Slovenian: Injekcijski peresnik umaknite z mesta injiciranja.
English: • Changes in how your liver works, increase in liver enzymes (shown in blood tests)
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov • spremenjeno delovanje vaših jeter, povečanje vrednosti jetrnih encimov (pokaže se v izvidih krvnih preiskav)
English: Start the injection (see Figure F).
Slovenian: Začnite injiciranje (glejte sliko F).
English: Remsima contains sodium
Slovenian: Zdravilo Remsima vsebuje natrij
English: Do not touch the needle cover.
Slovenian: Ne prijemajte zaščite igle.
English: Patients randomised
Slovenian: Starejši bolniki
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils
Slovenian: • ostale težave s kožo, kot so multiformni eritem, mehurji na koži in luščenje kože, ali turi
English: Do not use the syringe if the liquid is different to clear colourless or pale brown or contains particles in it.
Slovenian: Injekcijskega peresnika ne smete uporabiti, če tekočina ni bistra ali bledo rjava ali če so v njej prisotni neprosojni delci.
English: • Fungal infections such as yeast infection, or fungal infection of the nails
Slovenian: • glivične okužbe, na primer okužba s kvasovkami ali glivična okužba nohtov
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p<0.001 and 46.1% vs. 18.2%, p<0.001, respectively).
Slovenian: Klinično remisijo in celjenje sluznice v 54. tednu so ugotovili pri večjem odstotku bolnikov v (združeni) skupini, ki se je zdravila z infliksimabom, kot pa v skupini, ki je prejemala placebo (34,6 % v primerjavi s 16,5 %; p< 0,001, in 46,1 % v primerjavi z 18,2 %; p< 0,001).
English: Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button.
Slovenian: Viala (steklo tipa 1) z gumijastim zamaškom in aluminijasto zaporko, zaščiteno s plastično ploščico,
English: Remsima and Kineret should not be used together.
Slovenian: Zdravili Remsima in Kineret se ne smeta uporabljati skupaj.
English: The syringe is made from type I glass with a plunger stopper (flurotec-coated elastomer) and needle with a rigid needle shield.
Slovenian: Injekcijska brizga je izdelana iz stekla tipa I z batnim zamaškom (iz elastomera s prevleko Flurotec) in iglo s trdim ščitnikom za iglo.
English: If these medicines do not work well enough, you will be given Remsima to:
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Remsima za:
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation
Slovenian: krvavitev iz prebavil, driska, dispepsija, gastroezofagealni refluks, zaprtje občasni:
English: • Cancer
Slovenian: • rak
English: In addition:
Slovenian: Remsima:
English: Patients treated with Remsima should be given the package leaflet and the patient reminder card.
Slovenian: Bolniki, zdravljeni z zdravilom Remsima, morajo prejeti navodilo za uporabo in opozorilno kartico za bolnika.
English: • After proper training, if you feel you are well-trained and confident to inject Remsima yourself, your doctor may allow you to inject subsequent doses of Remsima yourself at home.
Slovenian: • Po ustreznem usposabljanju vam bo morda zdravnik dovolil, da si naknadne odmerke zdravila
English: The following side effects have been observed with Remsima:
Slovenian: Pri uporabi zdravila Remsima so opazili naslednje neželene učinke:
English: Powder for concentrate for solution for infusion (powder for concentrate) The powder is white.
Slovenian: prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat).