FrancophonIA/ELRC3.0 huggingface dataset:
English: For subsequent injections and after proper training in subcutaneous injection technique, patients may self-inject with Remsima if their physician determines that it is appropriate and with medical followup as necessary.
Slovenian: Po ustreznem usposabljanju glede tehnike subkutanega injiciranja si lahko bolniki sami injicirajo zdravilo Remsima, če je po presoji zdravnika to ustrezno in če se po potrebi izvaja naknadno spremljanje bolnika.
English: Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Slovenian: Ključni izsledki o učinkovitosti zdravila iz študij IMPACT in IMPACT 2 so prikazani v spodnji
English: Myocardial ischaemia/myocardial infarction
Slovenian: ishemija miokarda ali miokardni infarkt
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Remsima.
Slovenian: • Če zdravnik sumi, da je možno da imate tuberkulozo, vas bo lahko zdravil z zdravili za tuberkulozo, preden boste začeli zdravljenje z zdravilom Remsima.
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Slovenian: Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6.234 bolnikov-let (3.210 bolnikov), pa so poročali o 5 primerih limfomskihin 38 primerih nelimfomskih rakavih bolezni.
English: • Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
Slovenian: • Lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah).
English: Keratitis, periorbital oedema, hordeolum
Slovenian: keratitis, periorbitalni edem, hordeolum redki:
English: Anaphylactic shock, vasculitis, sarcoid-like reaction
Slovenian: anafilaktični šok, vaskulitis, sarkoidni podobna reakcija
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
Slovenian: • resne težave s kožo, na primer toksična epidermalna nekroliza, Stevens-Johnsonov sindrom in akutna generalizirana eksantematozna pustuloza
English: Suitability of the patient for subcutaneous home use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms of an allergic reaction before administering the next dose.
Slovenian: Oceniti je treba primernost bolnika za subkutano uporabo zdravila v domačem okolju in ga poučiti, da mora v primeru simptomov, ki so značilni za alergijsko reakcijo, pred injiciranjem naslednjega odmerka o tem obvestiti zdravstvenega delavca.
English: Remsima should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Slovenian: Zdravilo Remsima se sme pri otrocih uporabljati samo za zdravljenje Chronove bolezni ali ulceroznega kolitisa.
English: Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, vključno s katerimikoli drugimi zdravili za zdravljenje revmatoidnega artritisa in z zdravili, ki se jih dobi brez recepta, kot so vitamini in rastlinski pripravki.
English: The estimate of treatment difference was 0.27 with corresponding lower limit of the two-sided 95% confidence interval [CI] of 0.02 (95% CI: 0.02, 0.52), which was greater than the pre-specified non-inferiority margin of -0.6 indicating non-inferiority of Remsima subcutaneous formulation to Remsima intravenous formulation.
Slovenian: Ocenjena razlika je bila 0,27 z ujemajočo nižjo stopnjo na dvostranskem 95-% intervalu zaupanja [CI] 0,02 (95-% CI: 0,02; 0,52), ki je bila višja od predhodno opredeljene meje enakovrednosti -0,6, kar nakazuje, da je zdravilo Remsima v subkutani obliki enakovredno zdravilu Remsima v intravenski obliki.
English: Do not inject into skin that is within 5 cm of your belly button (navel), or is tender, damaged, bruised, or scarred.
Slovenian: Injiciranja ne smete izvajati na področju, ki je od vašega popka oddaljeno manj kot 5 centimetrov, ali na mestih z občutljivo, poškodovano, podpluto ali brazgotinasto kožo.
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25°C after removal from refrigeration.
Slovenian: Po rekonstituciji in redčenju Dokazano je bilo, da je razredčena raztopina kemično in fizikalno stabilna do 28 dni pri temperaturi 2 °C do 8 °C ter dodatnih 24 ur pri temperaturi 25°C, po tem ko se vzame iz hladilnika.
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Slovenian: • Pri nekaterih bolnikih, ki prejemajo zdravilo Remsima, so se pojavili simptomi bolezni imunskega sistema, imenovane lupus.
English: The required total volume of reconstituted Remsima solution has to be calculated.
Slovenian: Izračunati morate celoten volumen potrebne rekonstituirane raztopine zdravila Remsima.
English: Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Slovenian: Analiza populacijske farmakokinetike na podlagi podatkov, pridobljenih pri bolnikih z ulceroznim kolitisom (n=60), Crohnovo boleznijo (N=112), juvenilnim revmatoidnim artritisom (N=117) in boleznijo Kawasaki (N=16) v starostni skupini od 2 mesecev do 17 let, je pokazala, da je izpostavljenost infliksimabu nelinearno odvisna od telesne mase.
English: Patients with tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections (see section 4.4).
Slovenian: Bolniki s tuberkulozo ali z drugimi hudimi okužbami, kot so sepsa, abscesi in oportunistične okužbe (glejte poglavje 4.4).
English: The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Slovenian: Navidezni porazdelitveni volumen v stanju dinamičnega ravnovesja (mediana Vd od 3,0 do 4,1 litra) ni bil odvisen od danega odmerka, kar pomeni, da se infliksimab razporedi pretežno po žilnem razdelku.
English: If you forget or miss an appointment to receive Remsima, make another appointment as soon as possible.
Slovenian: Če ste pozabili ali izpustili odmerek zdravila Remsima Če ste pozabili ali izpustili dogovorjen termin, da bi prejeli zdravilo Remsima, se čim prej dogovorite za naslednjega.
English: In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: "Infusion reactions and hypersensitivity").
Slovenian: Pri bolnikih, ki so jim psoriazo vzdrževalno zdravili z infliksimabom brez spremljajočega imunomodulatorja, so se pri približno 28 % razvila protitelesa proti infliksimabu (glejte poglavje 4.4: ''Z infuzijo povezane reakcije in preobčutljivost'').
English: From experience with intravenous infliximab, if the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last administration.
Slovenian: Izkušnje z intravenskim infliksimabom kažejo, da če se znaki in simptomi bolezni ponovijo, lahko infliksimab ponovno uporabite v roku 16 tednov po zadnjem dajanju.
English: a. Hold the pen so that you can see the window.
Slovenian: a. Injekcijski peresnik primite tako, da bosta videli okence.
English: Remsima is a biosimilar medicinal product.
Slovenian: Zdravilo Remsima je biološko podobno zdravilo.
English: • The doctor will decide your dose and how often you will be given Remsima.
Slovenian: • Zdravnik bo določil odmerek, ki ga boste prejemali, in kako pogosto ga boste prejemali.
English: Most of these reactions may occur immediately or within 24 hours after subcutaneous injection.
Slovenian: Večina teh reakcij se lahko pojavi takoj po subkutanem zdravljenju z infliksimabom ali v 24 urah po njem.
English: Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI <150) and clinical response over time.
Slovenian: Sekundarna cilja študije sta bila odstotek bolnikov v klinični remisiji v 4. tednu (CDAI < 150) in klinični odziv po času.
English: Significant improvements from baseline were demonstrated in DLQI (p<0.001) and the physical and mental component scores of the SF 36 (p<0.001 for each component comparison).
Slovenian: Pri oceni po DLQI (p< 0,001) so dokazali bistveno izboljšanje glede na začetne vrednosti, pa tudi glede ocen telesne in duševne komponente po SF 36 (p< 0,001 za primerjavo vsake komponente).
English: Remsima must be given concomitantly with methotrexate.
Slovenian: Zdravilo Remsima morate uporabljati sočasno z metotreksatom.
English: • Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
Slovenian: Zdravniku povejte, če imate hepatitis B ali če sumite, da ste nosilec virusa hepatitis B.
English: c. With a quick and “dart-like” motion, insert the needle completely into the fold of the skin at a 45-degree angle.
Slovenian: c. S hitrim sunkom, podobnim metu pri pikadu, iglo vstavite do konca v kožno gubo pod 45stopinjskim kotom.
English: Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of Remsima is not available.
Slovenian: Informacij o prehodu bolnikov z zdravila Remsima v subkutani obliki na zdravilo Remsima v intravenski obliki ni na voljo.
English: In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: What Remsima looks like and contents of the pack
Slovenian: Izgled zdravila Remsima in vsebina pakiranja
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine.
Slovenian: • Pomembno je, da zdravniku vašega dojenčka in drugim zdravstvenim delavcem poveste, da ste prejemali zdravilo Remsima, še preden dojenček dobi katerokoli cepivo.
English: In studies in healthy subjects, the mean (± standard deviation) apparent clearance of Remsima 120 mg administered subcutaneously was 19.3 ± 6.9 mL/hr.
Slovenian: V študijah pri zdravih preiskovancih je mediana (± standardni odklon) navideznega očistka subkutano danega zdravila Remsima 120 mg znašala 19,3 ± 6,9 ml/uro.
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 že bili zdravljeni z zdravili proti TBC.
English: It is used in adults for the following inflammatory disease:
Slovenian: Uporablja se za zdravljenje naslednje vnetne bolezni pri odraslih:
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of infliximab treatment should be carefully considered before initiation of infliximab therapy.
Slovenian: Pri bolnikih, ki so živeli ali potovali v kraje, kjer so invazivne glivične okužbe, kot so histoplazmoza, kokcidioidomikoza ali blastomikoza, endemične, je treba skrbno pretehtati koristi in tveganja zdravljenja z infliksimabom, preden bolniku uvedete to zdravilo.
English: Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Remsima is indicated.
Slovenian: Zdravljenje z zdravilom Remsima mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju bolezni, za katere je indicirano zdravilo Remsima.
English: Before reconstitution:
Slovenian: Pred rekonstitucijo
English: b. Let the skin dry before injecting.
Slovenian: b. Pred injiciranjem počakajte, da se koža posuši.
English: Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki, so opisani v poglavjih 4.8 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: In Part 2 of this study, among 357 patients who were enrolled to receive 2 doses of Remsima 3 mg/kg intravenously at Weeks 0 and 2, 167 patients were randomised to receive Remsima 120 mg subcutaneously at Week 6 and every 2 weeks up to Week 54, while 176 patients were randomised to receive Remsima 3 mg/kg intravenously at Weeks 6, 14 and 22 and then switched to Remsima 120 mg subcutaneous at Week 30 once-every 2 weeks up to Week 54.
Slovenian: V 2. delu študije je bilo 167 od 357 bolnikov, ki so bili v študijo vključeni, da bi prejeli 2 odmerka zdravila Remsima 3 mg/kg intravensko na 0. in 2. teden, randomiziranih v skupino, ki je zdravilo Remsima 120 mg prejela subkutano na 6. teden in nato vsaka dva tedna do 54. tedna, 176 bolnikov pa je bilo randomiziranih v skupino, ki je prejela zdravilo Remsima 3 mg/kg intravensko na 6., 14. in 22. teden, nato pa je na 30. teden prešla na zdravilo Remsima 120 mg subkutano enkrat na dva tedna vse do 54. tedna.
English: a. Select an injection site.
Slovenian: a. Izberite mesto injiciranja.
English: Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
Slovenian: Kortikosteroidi ne kažejo klinično pomembnega vpliva na farmakokinetiko infliksimaba.
English: Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Srčno popuščanje Infliksimab morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II
English: Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Slovenian: Zdravilo Remsima je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih bolnikih, ki so se nezadostno odzvali na konvencionalno terapijo.
English: For this reason, the initial intravenous administrations should take place where emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway is immediately available.
Slovenian: Zato je treba zdravilo prvič dati intravensko na mestu, kjer so neposredno na voljo sredstva za nujno pomoč, npr. adrenalin, antihistaminiki, kortikosteroidi in oprema za umetno ventilacijo.
English: Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Slovenian: Zdravljenje z zdravilom Remsima mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju revmatoidnega artritisa, vnetnih bolezni črevesa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze.
English: After single doses of 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects, the mean Cmax values were 10.0, 15.1 and 23.1 µg/mL, respectively, and for all doses infliximab could be detected in the serum for at least 12 weeks thereafter.
Slovenian: Po enkratnem odmerku 120, 180 ali 240 mg subkutanega infliksimaba pri zdravih preiskovancih so bile njihove mediane vrednosti Cmaks 10,0, 15,1 in 23,1 mikrogramov/ml, pri vseh odmerkih pa so infliksimab našli v serumu še najmanj 12 tednov po odmerjanju.
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Slovenian: V tej študiji je bilo 150 bolnikov s srčnim popuščanjem stopnje III do IV po NYHA (iztisni delež levega ventrikla ≤ 35 %) zdravljenih s tremi infuzijami: infliksimab v odmerkih 5 mg/kg, 10 mg/kg ali s placebom več kot 6 tednov.
English: • The front of the thighs.
Slovenian: • Sprednjo stran stegna.
English: • You should receive recommended vaccinations before starting Remsima treatment.
Slovenian: • Vsa priporočena cepljenja morate prejeti pred začetkom zdravljenja z zdravilom Remsima.
English: Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Slovenian: Zdravilo Remsima je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih bolnikih v primeru nezadostnega odziva na predhodno zdravljenje s protirevmatičnimi zdravili DMARD.
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 infliksimab, se je razvil rak, vključno z zelo neobičajnimi oblikami, ki se včasih končajo s smrtnim izidom.
English: Single intravenous doses up to 20 mg/kg have been administered without toxic effects and repeated doses of Remsima subcutaneous formulation up to 240 mg have been administered without toxic effects.
Slovenian: Uporabljeni so bili enkratni intravenski odmerki infliksimaba do 20 mg/kg, ki niso povzročili toksičnih učinkov, in večkratni odmerki zdravila Remsima v subkutani obliki do 240 mg, ki prav tako niso povzročili toksičnih učinkov.
English: a. Look at the pen and confirm that the olive green plunger rod is filling the window completely.
Slovenian: a. Preglejte injekcijski peresnik in potrdite, da je v celotnem okencu viden olivno zeleni bat brizge.
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of infliximab (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Slovenian: Skrajšane infuzije pri indikacijah za odrasle bolnike Pri skrbno izbranih odraslih bolnikih, ki so dobro prenesli vsaj 3 začetne 2-urne infuzije infliksimaba (uvajalna faza zdravljenja) in so trenutno na vzdrževalnem zdravljenju, lahko razmislite o skrajšanju naslednjih infuzij, vendar ne na manj kot 1 uro.
English: There is no specific treatment for Remsima overdose.
Slovenian: Za preveliko odmerjanje zdravila Remsima ni specifičnega zdravljenja.
English: Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
Slovenian: Bolniki morajo v primeru simptomov resnih alergijskih reakcij takoj poiskati zdravniško pomoč (glejte poglavje 4.4).
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
Slovenian: V obeh študijah je bilo dovoljeno sočasno jemanje stalnih odmerkov folne kisline, peroralnih kortikosteroidov (≤ 10 mg/dan) in/ali nesteroidnih protivnetnih zdravil (NSAID).
English: There is insufficient information regarding the switching of patients who received the intravenous infusions of infliximab higher than 3 mg/kg every 8 weeks to the subcutaneous formulation of Remsima.
Slovenian: Na voljo ni zadostnih informacij o prehodu pri bolnikih, ki so na vsakih 8 tednov prejemali infuzije infliksimaba v odmerku, višjem od 3 mg/kg, na zdravilo Remsima v subkutani obliki.
English: • Do not remove the cap until you are ready to inject.
Slovenian: Slika A • Pokrovčka ne smete odstraniti, dokler niste pripravljeni na injiciranje.
English: Ask your doctor to record the type and date of your last screening(s) for TB on the card.
Slovenian: Zdravnik naj zabeleži tip in datum zadnjega presejalnega testa(ov) za TBC na opozorilno kartico.
English: The mean scores for DAS28 (CRP) and DAS28 (ESR) gradually decreased from baseline at each time point until Week 54 in each treatment arm (see Table 5 and Table 6, respectively).
Slovenian: Povprečne vrednosti za DAS28 (CRP) in DAS28 (ESR) so glede na izhodišče postopoma upadale v vsaki časovni točki do 54. tedna za vsako terapevtsko skupino (glejte
English: Clean the injection site.
Slovenian: Očistite mesto injiciranja.
English: Available data suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval.
Slovenian: Podatki, ki so na voljo, kažejo povečano tveganje za pozno preobčutljivost pri povečevanju obdobja brez prejemanja infliksimaba.
English: After use, place the pre-filled syringe/ pre-filled syringe with automatic needle guard/ pre-filled pen into a puncture resistant container and discard as required by local regulations.
Slovenian: Po uporabi napolnjeno injekcijsko iglo/napolnjeno injekcijsko iglo s samodejnim ščitnikom za iglo/napolnjen injekcijski peresnik odložite v vsebnik, odporen na prebadanje, in zavrzite skladno z lokalnimi predpisi.
English: Treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 3 mg/kg given 2 weeks apart.
Slovenian: Zdravljenje z zdravilom Remsima za subkutano dajanje je treba uvesti kot vzdrževalno zdravljenje 4 tedne po zadnjem dajanju dveh intravenskih infuzij infliksimaba 3 mg/kg v razmiku dveh tednov.
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Slovenian: Priporočljivo je, da se pri pediatričnih bolnikih pred uvajanjem zdravila Remsima, če je mogoče, opravijo vsa cepljenja v skladu s trenutnimi smernicami za cepljenje.
English: Doing so may result in a needle stick injury.
Slovenian: Če to storite, se lahko zbodete z iglo.
English: Table 7 Effects on response rate, data from ACCENT II (Week-14 responders)
Slovenian: Učinki na stopnjo odziva; podatki iz študije ACCENT II (bolniki z odzivom v 14. tednu)
English: A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Slovenian: Pri bolnikih z zmerno do hudo psoriazo je bila načrtovana klinična študija za oceno učinkovitosti in varnosti dolgotrajnega vzdrževalnega zdravljenja v primerjavi s ponovnim dajanjem uvodne sheme zdravljenja z infliksimabom (največ štiri infuzije v 0., 2., 6. in 14. tednu) po izbruhu bolezni.
English: b. Remove the pen from the carton stored in your refrigerator.
Slovenian: b. Injekcijski peresnik vzemite iz embalaže, ki je bila shranjena v hladilniku.
English: Systemic injection reaction and localised injection site reaction in adult patients administered with Remsima subcutaneous formulation
Slovenian: Sistemska z injiciranjem povezana reakcija in lokalna reakcija na mestu injiciranja pri odraslih bolnikih, ki so prejeli zdravilo Remsima v subkutani obliki
English: Inspect the syringe.
Slovenian: Injekcijsko brizgo preglejte.