FrancophonIA/ELRC3.0 huggingface dataset:
English: After the injection 12.
Slovenian: Po injiciranju 12.
English: Your doctor will advise you what other medicines you must keep using while you are having Remsima.
Slovenian: Zdravnik vam bo svetoval, katera zdravila morate še naprej jemati tudi med zdravljenjem z zdravilom Remsima.
English: Remsima is indicated for:
Slovenian: Zdravilo Remsima je indicirano za:
English: One serious infusion reaction (<1%) occurred in a patient on infliximab monotherapy.
Slovenian: Pojavila se je ena resna z infuzijo povezana reakcija (< 1 %), in sicer pri bolniku na monoterapiji z infliksimabom.
English: • Treatment with TNF blockers such as Remsima may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Slovenian: • Zdravljenje z zaviralci TNF, kot je zdravilo Remsima, lahko vodi do reaktivacije virusa hepatitisa B pri bolnikih, ki prenašajo ta virus, kar je lahko v nekaterih primerih življenjsko nevarno.
English: Infliximab should be administered intravenously over a 2 hour period.
Slovenian: Infliksimab je treba dajati intravensko v času 2 ur.
English: If you are not sure when to inject Remsima, call your doctor.
Slovenian: Če niste prepričani, kdaj si morate injicirati zdravilo Remsima, pokličite zdravnika.
English: Remsima contains sorbitol
Slovenian: Zdravilo Remsima vsebuje sorbitol
English: It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient, as prescribed.
Slovenian: Pomembno je, da preverite nalepko zdravila in zagotovite, da bolnik prejme ustrezno obliko (intravensko ali subkutano), ki mu je bila predpisana.
English: Each new injection site should be at least 3 cm away from the previous injection site.
Slovenian: Vsako novo mesto injiciranja mora biti od prejšnjega mesta oddaljeno vsaj 3 cm.
English: After the injection 13.
Slovenian: Po injiciranju 13.
English: • Remsima will be given to you by your doctor or nurse.
Slovenian: • Zdravilo Remsima vam bo dal zdravnik ali medicinska sestra.
English: The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from the ACT 1 and ACT 2 studies and their extensions.
Slovenian: Podatke o odstotku preiskovancev, ki so jim opravili kolektomijo kadar koli v času 54 tednov po prvi infuziji proučevanega zdravila iz študij ACT 1 in ACT 2 ter njihovih podaljšanj, so zbrali in jih združili.
English: Table 5 Mean (SD) Actual Values of DAS28 (CRP and ESR)
Slovenian: Povprečne (SD) dejanske vrednosti DAS28 (CRP in ESR)
English: ≥75% improvement
Slovenian: ≥ 75 % izboljšanje
English: 5 mg/kg (at week 24)
Slovenian: 5 mg/kg (24 teden)
English: Most of these reactions were mild to moderate and resolved spontaneously without any treatment within a day.
Slovenian: Večina teh reakcij je bilo blagih do zmernih in so spontano izzvenele v enem dnevu brez kakršnega koli zdravljenja.
English: a. Pull the cap straight off and set it aside.
Slovenian: a. Pokrovček povlecite naravnost dol in ga odložite na stran.
English: Do not recycle the injecting device.
Slovenian: Pripomočka za injiciranje ne reciklirajte.
English: Therefore, subcutaneous use of Remsima is recommended for use only in adults.
Slovenian: Zato se uporaba zdravila Remsima v subkutani obliki priporoča samo pri odraslih bolnikih.
English: Note: After you remove the pen from the injection site, the needle will be automatically covered (see Figure I).
Slovenian: Opomba: Ko injekcijski peresnik umaknete z mesta injiciranja, se igla samodejno pokrije (glejte sliko I).
English: If you received Remsima while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Slovenian: Če ste v času nosečnosti prejeli zdravilo Remsima, lahko cepljenje dojenčka s cepivom BCG (uporablja se za preprečevanje tuberkuloze) v obdobju 6 mesecev po rojstvu povzroči okužbo z resnimi zapleti, vključno s smrtjo.
English: Take your next dose on the next originally planned date and thereafter biweekly.
Slovenian: Naslednji odmerek vzemite naslednji prvotno načrtovani datum in nato vsaka dva tedna.
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may be life-threatening.
Slovenian: • Te okužbe so lahko resne in vključujejo tuberkulozo okužbe, ki jih povzročajo virusi, glive bakterije ali drugi organizmi iz okolja, ter sepso, kar je lahko življenjsko nevarno.
English: b. Keep holding the pen firmly against the skin and listen for the 2nd loud “click.”
Slovenian: b. Injekcijski peresnik še naprej držite trdno ob kožo in počakajte, dokler ne zaslišite glasnega drugega »klika«.
English: • Infection due to a live vaccine because of a weakened immune system.
Slovenian: • okužba zaradi živega cepiva zaradi oslabljenega imunskega sistema.
English: The incidence of anti-infliximab antibodies following the subcutaneous infliximab was demonstrated to be not higher than that of the intravenous infliximab and had no significant impact on efficacy (determined by disease activity score in 28 joints [DAS28] and American College of Rheumatology criteria 20 [ACR20]) and the safety profile.
Slovenian: Imunogenost Pojavnost protiteles proti infliksimabu po subkutanem dajanju infliksimaba ni bila višja kot po intravenskem dajanju infliksimaba ter ni imela nobenega pomembnega vpliva na učinkovitost (kot je bilo ugotovljeno z oceno aktivnosti bolezni v 28 sklepih [DAS28] in merilom ACR 20 Ameriškega revmatološkega združenja [ACR20]) in varnostni profil.
English: Remsima will generally be stored by the health professionals.
Slovenian: V glavnem bodo za shranjevanje zdravila Remsima poskrbeli zdravstveni delavci.
English: This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Slovenian: To vključuje bolezni, kot so multipla skleroza, Guillain-Barréjev sindrom, če ste imeli napade krčev ali so vam diagnosticirali ″optični nevritis″.
English: In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika zdraviti simptomatsko in poseči po ustreznih podpornih ukrepih.
English: What Remsima is and what it is used for
Slovenian: Kaj je zdravilo Remsima in za kaj ga uporabljamo
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies
Slovenian: Protitelesa proti celičnemu jedru (ANA-anticelular antibodies)/protitelesa proti dvoverižni DNA (dsDNA)
English: a. After the syringe is empty, slowly lift your thumb from the plunger until needle is completely covered by the automatic needle guard.
Slovenian: a. Ko je injekcijska brizga prazna, palec počasi dvignite z bata, dokler igla ni v celoti pokrita s samodejnim ščitnikom za iglo.
English: a. Clean the injection site with an alcohol swab.
Slovenian: a. Mesto injiciranja očistite z alkoholnim zložencem.
English: Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer.
Slovenian: Dosedanji podatki ne kažejo, da da zdravljenje z infliksimabom vpliva na tveganje za nastanek displazije ali karcinoma kolona.
English: Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Slovenian: Infliksimab je monoklonsko protitelo - Vrsta beljakovine, ki se veže na določeno tarčo v telesu, imenovano TNF (tumorje nekrotizirajoči faktor).
English: Hypersensitivity to the active substance, to other murine proteins or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, druge glodalske beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Talk to your doctor if you are on a low salt diet.
Slovenian: če ste na dieti z zmanjšanim vnosom soli.
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Remsima.
Slovenian: • Zdravnik vam bo dal tudi opozorilno kartico za bolnika, na kateri so navedeni pomembnejši varnostni podatki, ki jih morate poznati, preden prejmete zdravilo Remsima in tudi med zdravljenjem z njim.
English: Vaccine breakthrough infection (after in utero exposure to infliximab)*.
Slovenian: okužba po cepljenju (po in utero izpostavitvi infliksimabu)*
English: ACR response (% of patients) N
Slovenian: Odziv ACR (% bolnikov) N
English: • Children should receive recommended vaccinations before starting Remsima treatment.
Slovenian: • Otroci morajo prejeti priporočena cepljenja, preden se začnejo zdraviti z zdravilom Remsima.
English: A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥220 ≤400) received a single infusion of 5 mg/kg at week 0.
Slovenian: Skupaj 573 bolnikov z zmerno do hudo aktivno Crohnovo boleznijo (CDAI ≥ 220 ≤ 400) je prejelo enkratno infuzijo odmerka 5 mg/kg v tednu 0.
English: • A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Remsima
Slovenian: • Opomnik za bolnike, da morajo pokazati opozorilno kartico za bolnika vsem zdravstvenim delavcem, ki sodelujejo pri zdravljenju (tudi v nujnih stanjih) ter sporočilo za zdravstvene delavce, da bolnik uporablja zdravilo Remsima.
English: There are no known side effects of having too much of Remsima.
Slovenian: Ni poznanih neželenih učinkov zaradi prejetja prevelikega odmerka zdravila Remsima.
English: All systemic injection reactions were mild to moderate.
Slovenian: Vse sistemske z injiciranjem povezane reakcije so bile blage do zmerne.
English: You will find detailed “Instructions for Use” at the end of this leaflet.
Slovenian: Na koncu tega listka so podrobna »Navodila za uporabo zdravila«.
English: The dose and the number of Remsima vials have to be calculated.
Slovenian: Odmerek in število potrebnih vial zdravila Remsima morate izračunati.
English: • Tell your surgeon or dentist that you are having treatment with Remsima by showing them your patient reminder card.
Slovenian: • Obvestite kirurga ali zobozdravnika, da prejemate zdravilo Remsima in mu pokažite svojo opozorilno kartico za bolnika.
English: While using Remsima you should not receive live vaccines.
Slovenian: Med uporabo zdravila Remsima ne smete prejeti živih cepiv.
English: N/A 6.7% N/A 1.7%
Slovenian: N/A 49,4 N/A 6,7 % N/A 1,7 %
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: The safety profile of Remsima subcutaneous formulation in combination with methotrexate was evaluated in a Phase I/III parallel group study in patients with active rheumatoid arthritis.
Slovenian: Varnostni profil zdravila Remsima v subkutani obliki skupaj z metotreksatom so ocenjevali v študiji faze I/III pri vzporednih skupinah pri bolnikih z aktivnim revmatoidnim artritisom.
English: The bioavailability of infliximab subcutaneous, estimated in a population PK model, is 58% (95% CI:
Slovenian: Biološka razpoložljivost infliksimaba subkutano, ocenjena na populacijskem modelu farmakokinetike, je 58 % (95 % CI: 54 % - 62 %).
English: In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy.
Slovenian: Na splošno bolniki, pri katerih se je pojavilo zvišanje ALT in AST, niso imeli simptomov in nenormalni izvidi so se zmanjšali ali normalizirali bodisi z nadaljevanjem ali z ukinitvijo zdravljenja z infliksimabom, ali ob prilagoditvi drugih sočasnih terapij.
English: Remsima belongs to a group of medicines called ‘TNF blockers'.
Slovenian: Zdravilo Remsima spada v skupino zdravil, ki se imenujejo "zaviralci TNF".
English: The physician should ensure appropriate follow-up of patients for any systemic injection reaction and localised injection site reaction after the initial subcutaneous injection is administered.
Slovenian: Zdravnik mora zagotoviti ustrezno spremljanje bolnikov zaradi morebitnih sistemskih z injiciranjem povezanih reakcij in lokalnih reakcij na mestu injiciranja po začetnem subkutanem injiciranju.
English: Single doses up to 20 mg/kg have been administered without toxic effects.
Slovenian: Uporabljeni so bili enkratni odmerki infliksimaba do 20 mg/kg, ki niso povzročili toksičnih učinkov.
English: Contents of the pack and other information What Remsima contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Remsima
English: Remsima may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Remsima ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Children may receive some vaccines during treatment with Remsima but should not receive live vaccines while using Remsima.
Slovenian: Otroci lahko med zdravljenjem z zdravilom Remsima prejmejo nekatera cepiva, vendar med uporabo zdravila Remsima ne smejo prejeti živih cepiv.
English: b. Using your other hand, gently pinch a fold of skin you cleaned.
Slovenian: b. Z drugo roko nežno naredite kožno gubo na mestu, kjer ste kožo očistili.
English: Subcutaneous administration of Remsima is not recommended for paediatric use and no data are available on the use of Remsima administered subcutaneously in the paediatric population.
Slovenian: Subkutano dajanje zdravila Remsima pri pediatrični populaciji ni priporočeno in ni na voljo nobenih podatkov o uporabi zdravila Remsima subkutano pri pediatrični populaciji.
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE
Slovenian: Učinki na ACRn, strukturno poškodbo sklepov in funkcijo sklepov v 54. tednu, ASPIRE
English: ACR 50 response*
Slovenian: ACR 50* Odziv
English: This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with Remsima.
Slovenian: Ta opozorilna kartica za bolnika vsebuje pomembne varnostne informacije, ki jih morate poznati preden prejmete zdravilo Remsima, ter med zdravljenjem z njim.
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Slovenian: * Infliksimab je himerno humano-glodalsko monoklonsko protitelo IgG1, pridobljeno iz celic glodalskega hibridoma s tehnologijo rekombinantne DNK.
English: The required volume of reconstituted Remsima solution should slowly be added to the 250-mL infusion bottle or bag and gently be mixed.
Slovenian: Potrebni volumen rekonstituirane raztopine zdravila Remsima morate počasi dodajati v 250-ml infuzijske steklenice ali vrečke in rahlo premešati.
English: Do not warm the syringe using heat sources such as hot water or a microwave.
Slovenian: Injekcijske brizge ne smete segrevati z viri toplote, kot je topla voda ali mikrovalovna pečica.
English: N/A 4.4% N/A 1.5%
Slovenian: N/A 53,0 N/A 4,4 % N/A 1,5 %
English: The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Slovenian: Delež bolnikov z okužbami je bil v preskušanju C0168T72 podoben kot v študiji Crohnove bolezni pri pediatričnih bolnikih (REACH), a večji od deleža v študijah ulceroznega kolitisa pri odraslih bolnikih (ACT 1 in
English: Note: You may see air bubbles in the liquid.
Slovenian: Opomba: V tekočini so lahko prisotni mehurčki.
English: Your doctor may recommend temporarily stopping Remsima.
Slovenian: Zdravnik vam bo morda priporočil začasno prekinitev zdravljenja z zdravilom Remsima.
English: EXP, if not refrigerated ___________________
Slovenian: EXP pri sobni temperaturi___________________
English: In the REACH study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Slovenian: Okužbe V preskušanju REACH so o okužbah poročali pri 56,3 % randomiziranih preiskovancih, zdravljenih z infliksimabom.
English: It is important to check the product labels to ensure that the correct formulation is being given as prescribed.
Slovenian: Pomembno je, da preverite nalepko zdravila in zagotovite, da boste prejeli ustrezno obliko zdravila, ki vam je bila predpisana.
English: The analysis of other efficacy endpoints showed that efficacy profile of Remsima subcutaneous formulation compared to Remsima intravenous formulation in RA patients was generally comparable in terms of disease activity measured by DAS28 (CRP and ESR) and ACR response up to Week 54.
Slovenian: Analiza drugih primarnih opazovanih dogodkov je pokazala, da je profil učinkovitosti zdravila Remsima v subkutani obliki na splošno primerljiv s profilom učinkovitosti zdravila Remsima v intravenski obliki pri bolnikih z RA z vidika aktivnosti bolezni, izmerjene z odzivom DAS28 (CRP in ESR) in ACR do 54. tedna.
English: You may receive some vaccines during treatment with Remsima but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remsima because they may cause infections.
Slovenian: Med zdravljenjem z zdravilom Remsima lahko prejmete nekatera cepiva, vendar med uporabo zdravila Remsima ne smete prejeti živih cepiv (cepiv, ki vsebujejo žive, a oslabljene povzročitelje okužb), saj lahko le-ta povzročijo okužbo.
English: Systemic injection reaction/ localised injection site reaction/ hypersensitivity
Slovenian: Sistemska z injiciranjem povezana reakcija/lokalizirana reakcija na mestu injiciranja/preobčutljivost
English: b CDAI <150 at both Week 30 and 54 and not receiving corticosteroids in the 3 months prior to
Slovenian: b CDAI< 150 tako v 30. tednu kot v 54. tednu, brez prejemanja kortikosteroidov v 3 mesecih pred 54. tednom pri bolnikih, ki so prejemali kortikosteroide na začetku študije
English: • That treatment with Remsima may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Slovenian: • Da lahko zdravljenje z zdravilom Remsima zveča tveganje za resne okužbe/sepso, oportunistične okužbe, tuberkulozo, reaktivacijo hepatitisa B in okužbo z BCG pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, in kdaj poiskati zdravniško pomoč.
English: The subcutaneous administration of Remsima to New Zealand White rabbits was well tolerated at the actual concentration to be used in humans.
Slovenian: Novozelandski beli zajci so dobro prenašali zdravilo Remsima, ki so ga prejeli subkutano v dejanskih koncentracijah, namenjenih uporabi pri ljudeh.
English: • You will be monitored while you are given Remsima and also for 1 to 2 hours afterwards.
Slovenian: • Med prejemanjem zdravila Remsima in še eno do dve uri potem vas bodo spremljali.
English: Methotrexate was given concomitantly.
Slovenian: Sočasno so prejemali metotreksat.
English: Your doctor will start your treatment with two Remsima intravenous infusion doses of 3 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours).
Slovenian: Zdravnik bo začel zdravljenje z dvema intravenskima infuzijama zdravila Remsima v odmerku 3 mg za kilogram telesne mase (ki ju boste prejeli v veno, običajno na roki, v obdobju dveh ur).
English: ACR 70 response* PASI response (% of patients)b N
Slovenian: ACR 70* Odziv PASI (% bolnikov)b N
English: The medicinal product may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Slovenian: Zdravilo lahko shranite pri temperaturi do 25 °C za največ 14 dni.
English: • A rare blood cancer affecting mostly young men (hepatosplenic T-cell lymphoma)
Slovenian: • redka vrsta krvnega raka, ki prizadane predvsem mlade moške (hepatosplenični limfom T celic)
English: If jaundice and/or ALT elevations ≥5 times the upper limit of normal develop(s), infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Slovenian: Če se pojavi zlatenica in/ali zvišanje vrednosti ALT ≥ 5-kratno zgornjo mejo normale, prenehajte z uporabo infliksimaba in temeljito raziščite vzroke za nenormalne izvide.
English: • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Remsima.
Slovenian: • Obvestite zdravnika, če imate na koži nenormalne odprtine (fistule), preden začnete prejemati zdravilo Remsima.
English: ≥90% improvement
Slovenian: N ≥ 90 % izboljšanje
English: • If you received Remsima during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: • Če ste v času nosečnosti prejemali zdravilo Remsima, ima vaš dojenček lahko povečano tveganje za okužbe.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C - 8°C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Slovenian: Vendar, če je bila raztopina pripravljena v aseptičnih pogojih, jo lahko do 28 dni shranjujete v hladilniku pri temperaturi 2 °C - 8 °C ter dodatnih 24 ur pri temperaturi 25 °C, po tem ko jo vzamete iz hladilnika.
English: Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician.
Slovenian: Ker verjetnost povečanega tveganja za nastanek karcinoma pri bolnikih z novo diagnosticirano displazijo, ki se zdravijo z zdravilom Remsima, ni ugotovljena, mora zdravnik skrbno pretehtati tveganje in koristi nadaljevanja zdravljenja za posameznega bolnika.
English: • Some patients receiving infliximab via injection under the skin have experienced local injection site reactions.
Slovenian: • Pri nekaterih bolnikih, ki so infliksimab prejeli z injiciranjem pod kožo, so se pojavile lokalne reakcije na mestu injiciranja.
English: • Tell your doctor before you are given Remsima if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Slovenian: • Preden prejmete zdravilo Remsima, povejte zdravniku, če imate ali ste imeli kdaj v preteklosti limfom (vrsta krvnega raka) oziroma katero koli drugo vrsto raka.
English: The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professionals(s) (HCPs) treating the patient about on-going treatment with the product.
Slovenian: Kartica je namenjena beleženju datumov in rezultatov določenih prefiskav kot tudi lažji izmenjavi posebnih informacij glede trenutnega zdravljenja z zdravilom med bolnikom in zdravstvenim(i) delavcem(i), ki sodeluje(jo) pri zdravljenju bolnika.
English: Patients with no deterioration/patients evaluated (%)c
Slovenian: ± SDc) medianac (interkvartilni razmik) bolniki brez poslabšanja/ pregledani bolniki (%)c spreminjanje HAQ
English: Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test:
Slovenian: Zdravnik naj zabeleži tip in datum zadnjega presejaln-ega(ih) test-a(ov) za tuberkulozo (TBC):
English: A damaged pen may not function properly.
Slovenian: Poškodovan injekcijski peresnik morda ne bo pravilno deloval.
English: Remsima works by selectively attaching to TNF alpha and blocking its action.
Slovenian: Zdravilo Remsima deluje tako, da se selektivno veže na TNF-alfa in zavira njegovo delovanje.