FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Slovenian: (glejte poglavje 5.1) kot pri odraslih bolnikih s Crohnovo boleznijo: anemija (10,7 %), kri v blatu (9,7 %), levkopenija (8,7 %), zardevanje (8,7 %), virusna okužba (7,8 %), nevtropenija (6,8 %), bakterijska okužba (5,8 %), alergijska reakcija dihal (5,8 %).
English: If you miss a dose of Remsima for 8 days or more, after the original scheduled dose, you should not take the missed dose.
Slovenian: Če ste odmerek zdravila Remsima zamudili 8 dni ali več, po prvotnem načrtovanem odmerku ne smete jemati manjkajočega odmerka.
English: a. Leave the syringe at room temperature for 30 minutes to allow it to naturally warm up.
Slovenian: a. Injekcijsko brizgo pustite 30 minut na sobni temperaturi, da se segreje na sobno temperaturo.
English: Clinical remission at Week 8a Clinical remission at Week 30a Sustained remission(in remission at both Week 8 and Week 30)a
Slovenian: Klinična remisija v 30. tednua Trajnejša remisija (remisija tako v 8. tednu kot v 30. tednu)a
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Slovenian: Povzetek odzivov PASI,vrednosti PGA in delež bolnikov z nohti brez psoriatičnih sprememb v 10., 24. in 50. tednu.
English: Sorbitol content Remsima contains 45 mg sorbitol per 1 mL (in each 120 mg dose).
Slovenian: Vsebnost sorbitola Zdravilo Remsima vsebuje 45 mg sorbitola na 1 ml (v enem 120-mg odmerku).
English: Table 2 Proportion of patients with increased ALT activity in clinical studies using intravenous infliximab
Slovenian: Preglednica 2 Delež bolnikov s povišano vrednostjo ALT v kliničnih preskušanjih z intravenskim infliksimabom
English: Store at 2°C - 8°C.
Slovenian: Shranjujte pri temperaturi 2°C - 8°C.
English: c. Apply an adhesive bandage, if necessary.
Slovenian: c. Po potrebi namestite obliž.
English: b. Remove the syringe from the carton stored in your refrigerator by holding the middle of the syringe body.
Slovenian: b. Injekcijsko brizgo vzemite iz embalaže, ki je bila shranjena v hladilniku, tako da jo primete na sredini ohišja.
English: Mean ± SDc a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Slovenian: ± SDc a Kontrolna skupina: Vsi bolniki so imeli aktivni revmatoidni artritis kljub zdravljenju s stalnimi odmerki metotreksata že 6 mesecev pred vključitvijo v študijo; te odmerke so prejemali še naprej ves čas študije.
English: Paediatric Crohn's disease (6 to 17 years)
Slovenian: Pediatrična populacija Pediatrična Crohnova bolezen (6 do 17 let)
English: If these medicines or treatments do not work well enough, you will be given Remsima to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ali terapije ne delujejo dovolj dobro delovale, boste prejeli zdravilo Remsima za zmanjševanje znakov in simptomov bolezni.
English: If the dose is delayed by 8 days or more, the patients should be instructed to skip the missed dose, wait until their next scheduled dose, and then remain on their original bi-weekly dosing schedule.
Slovenian: Če je bolnik izpustil odmerek za 8 dni ali več, mora preskočiti izpuščeni odmerek in počakati do naslednjega načrtovanega odmerka, nato pa nadaljevati s prvotnim odmerjanjem vsaka dva tedna.
English: These patients were classified as week-2 responders and were included in the primary analysis (see Table 5).
Slovenian: Ti bolniki so bili razvrščeni v skupino z odzivom v 2. tednu zdravljenja in so bili vključeni v primarno analizo
English: After administration of infliximab 120 mg subcutaneously every 2 weeks (from Week 6 after 2 doses of intravenous infliximab at Weeks 0 and 2) to patients with active rheumatoid arthritis who were concomitantly treated with MTX, the median (CV%) Ctrough level at Week 22 was 12.8 µg/mL
Slovenian: Po odmerjanju infliksimaba 120 mg subkutano na dva tedna (od 6. tedna naprej po 2 odmerkih intravenskega infliksimaba na 0. in 2. teden) pri bolnikih z aktivnim revmatoidnim artritisom, ki so sočasno prejemali MTX, je bila mediana stopnje Ctrough (CV%) na 22. teden 12,8 mikrogramov/ml
English: • Use the syringe ONLY if your healthcare provider has trained you on the right way to prepare for and to give an injection.
Slovenian: • Injekcijsko brizgo uporabite SAMO, če vas je vaš zdravstveni delavec poučil o pravilni pripravi na injiciranje in pravilni tehniki injiciranja.
English: • Children and adults taking Remsima may have an increased risk of developing lymphoma or another cancer.
Slovenian: • Otroci in odrasli, ki prejemajo zdravilo Remsima, imajo lahko povečano tveganje za pojav limfoma ali katere druge vrste raka.
English: • It is very important that you tell your doctor if you have ever had tuberculosis (TB), or if you have been in close contact with someone who has had TB.
Slovenian: Zelo pomembno je, da zdravniku poveste, če ste kdaj imeli tuberkulozo ali če ste bili v tesnem stiku s tuberkuloznim bolnikom.
English: How to use Remsima Rheumatoid arthritis
Slovenian: Kako uporabljati zdravilo Remsima Revmatoidni artritis
English: Studies with infliximab have not been performed in patients with liver or renal disease.
Slovenian: Študij z infliksimabom niso izvajali pri bolnikih z jetrno ali ledvično boleznijo.
English: • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Slovenian: • znaki težav z jetri (vključno z okužbo s hepatitisom B, če ste imeli hepatitis B v preteklosti), na primer porumenelost kože ali oči, temno rjavo obarvan urin, bolečina ali oteklina na zgornji desni strani želodčnega predela, bolečina v sklepih, kožni izpuščaji ali zvišana telesna temperatura.
English: a. Press the pen firmly against the skin.
Slovenian: a. Injekcijski peresnik trdno pritisnite ob kožo.
English: In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
Slovenian: V kontroliranih delih kliničnih študij zaviralcev TNF so opažali več primerov rakavih bolezni, vključno z limfomom, med bolniki, ki so prejemali zaviralec TNF, kot pri kontrolni skupini.
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 -0,70 ± 2,53 za skupino, ki je prejemala infliksimab; p< 0,001).
English: For the two initial intravenous infusions, patients may be pre-treated with, e.g., an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Slovenian: Pri dveh začetnih intravenskih infuzijah je mogoče bolnike premedicirati z npr. z antihistaminikom, hidrokortizonom in/ali paracetamolom in upočasniti hitrost infundiranja, še posebej, če so se z infuzijo povezane reakcije pojavile že kdaj prej (glejte poglavje 4.4).
English: The co-primary endpoints were the proportion of patients in clinical remission (CDAI <150) at week 30 and time to loss of response through week 54.
Slovenian: Druga dva primarna končna rezultata sta bila: odstotek bolnikov v klinični remisiji (CDAI < 150) v 30. tednu in čas do izginotja odziva na zdravilo v obdobju do 54. tedna.
English: Table 8 Effects on clinical response, clinical remission and mucosal healing at Weeks 8 and 30.
Slovenian: Učinki na klinični odziv, klinično remisijo in celjenje sluznice v 8. in 30. tednu
English: More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
Slovenian: Drugi znaki z alergijo povezanih neželenih učinkov, ki se lahko pojavijo do 12 dni po prejemu injekcije,so bolečina v mišicah, zvišana telesna temperatura, bolečine v sklepih ali v čeljusti, vnetje žrela ali glavobol.
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 (TNFβ).
Slovenian: Infliksimab je himerno humano-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 primary endpoint of the study was the treatment difference of the change from baseline of DAS28 (CRP) at Week 22.
Slovenian: Primarni končni opazovani dogodek je bila razlika DAS28 (CRP) od izhodiščne vrednosti do 22.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remsima therapy.
Slovenian: Priporočljivo je, da bolniki pred uvajanjem zdravila Remsima, če je mogoče, opravijo vsa cepljenja v skladu s trenutnimi veljavnimi smernicami za cepljenje.
English: During Remsima treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Slovenian: Med zdravljenjem z zdravilom Remsima je treba optimizirati druge sočasne terapije, npr. s kortikosteroidi in zdravili za zaviranje imunske odzivnosti.
English: If patients miss an injection of Remsima subcutaneous formulation, they should be instructed to take the missed dose immediately in case this happens within 7 days from the missed dose, and then remain on their original bi-weekly dosing schedule.
Slovenian: Če bolniki izpustijo injiciranje zdravila Remsima v subkutani obliki, si morajo izpuščeni odmerek injicirati takoj, če ni od izpuščenega odmerka preteklo več kot 7 dni, nato pa nadaljevati s prvotnim odmerjanjem vsaka dva tedna.
English: • able to close with a tight-fitting, puncture-resistant lid, without sharps being able to come out;
Slovenian: • ima tesno prilegajoč pokrov, ki je odporen na prebadanje, iz katerega ne morejo pasti ostri odpadki;
English: It is used in adults for the following inflammatory diseases:
Slovenian: Uporablja se za zdravljenje naslednje vnetne boleznien:
English: In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥5 swollen joints and ≥5 tender joints).
Slovenian: V drugem preskušanju (IMPACT 2) so proučevali učinkovitost in varnost infliksimaba pri 200 bolnikih z aktivnim psoriatičnim artritisom (≥ 5 oteklih sklepov in ≥ 5 bolečih sklepov).
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Slovenian: Najpogosteje prijavljene oportunistične okužbe s stopnjo smrtnosti > 5 % so bile pnevmocistoza, kandidiaza, listerioza in aspergiloza.
English: Remsima infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Slovenian: Infuzije zdravila Remsima morajo bolniku dajati kvalificirani zdravstveni delavci, ki so usposobljeni za ugotavljanje morebitnih težav pri infundiranju zdravil.
English: It is recommended that live vaccines not be given concurrently with infliximab.
Slovenian: Priporočamo, da živih cepiv ne dajete sočasno z infliksimabom.
English: In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a re-induction regimen is not recommended (see section 4.8).
Slovenian: Ponovna uporaba zdravila za vse indikacije V primeru prekinitve vzdrževalnega zdravljenja in potrebe po ponovni uvedbi zdravljenja, ni priporočljiva ponovna uporaba uvodne sheme (glejte poglavje 4.8).
English: It is important that you tell your baby's doctors and other health care professionals about your Remsima use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Slovenian: Remsima, 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: The safety profile of Remsima subcutaneous formulation (evaluated in 168 and 175 patients for the subcutaneous infliximab group and the intravenous infliximab group, respectively) from active rheumatoid arthritis patients was overall similar to the safety profile of the intravenous formulation.
Slovenian: Varnostni profil zdravila Remsima v subkutani obliki (ocenjen pri 168 bolnikih v skupini, ki je infliksimab prejemala subkutano, in pri 175 bolnikih v skupini, ki je infliksimab prejemala intravensko) pri bolnikih z aktivnim revmatoidnim artritisom je bil podoben varnostnemu profilu zdravila v intravenski obliki.
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Remsima in the infusion bag only.
Slovenian: Shranjevanje pri temperaturi 2 °C - 8 °C, ki presega 24 ur, se nanaša samo na pripravo zdravila
English: Side effects may also occur after your treatment with Remsima has stopped.
Slovenian: Neželeni učinki se lahko pojavijo tudi po koncu zdravljenja z zdravilom Remsima.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remsima treatment.
Slovenian: • Bolniki s KOPB in tisti, ki veliko kadijo, imajo lahko povečano tveganje za nastanek raka pri zdravljenju z zdravilom Remsima.
English: Inspect the medicine (see Figure B).
Slovenian: Preglejte zdravilo (glejte sliko B).
English: They are administered 2 weeks apart via intravenous infusion.
Slovenian: Odmerka boste prejeli v razmiku dveh tednov z intravensko infuzijo.
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Slovenian: Primarni cilj študije je bil odstotek bolnikov s kliničnim odzivom, ki je bil opredeljen kot ≥ 50 % zmanjšanje števila aktivnih fistul, iz katerih je ob rahlem pritisku iztekala črevesna vsebina, ob najmanj dveh zaporednih pregledih (v presledku 4 tednov) v primerjavi z izhodiščnim številom, brez povečanja odmerka zdravil ali potrebe po operaciji za zdravljenje Crohnove bolezni.
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab.
Slovenian: V poskusnem kliničnem preskušanju pri bolnikih z zmerno do hudo KOPB, ki so bili bodisi aktivni kadilci ali bivši kadilci, je bilo 157 odraslih bolnikov zdravljenih z zdravilom infliksimab.
English: Infliximabb
Slovenian: Infliksimab
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with infliximab and is positive for antibodies against double-stranded DNA, further treatment with infliximab must not be given (see section 4.8).
Slovenian: Če se po zdravljenju z infliksimabom pri bolniku pojavijo simptomi, ki kažejo na lupusu podoben sindrom, in je bolnik pozitiven na protitelesa proti dvoverižni DNA, ne sme več prejeti infliksimaba (glejte poglavje 4.8).
English: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis
Slovenian: okužbe spodnjih dihal (npr. bronhitis, pljučnica), dispneja,
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥220 ≤400) in a randomised, double-blinded, placebo-controlled, dose-response study.
Slovenian: Začetno zdravljenje pri zmerno do močno aktivni Crohnovi bolezni Učinkovitost infliksimaba v enkratnem odmerku so ocenjevali pri 108 bolnikih z aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 ≤ 400) v randomizirani, dvojno slepi, s placebom kontrolirani študiji odziva na različne odmerke zdravila.
English: Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving infliximab than in controls, both when infliximab was given as monotherapy and when it was used in combination with other immunosuppressive agents.
Slovenian: Zvišanje aminotransferaz (ALT pogosteje kot AST) so opazili pri večjem deležu bolnikov, ki so prejemali infliksimab, kot v kontrolni skupini, in sicer tako med dajanjem infliksimaba v monoterapiji kot pri njegovi uporabi v kombinaciji z drugimi imunosupresivnimi sredstvi.
English: Remsima should be administered intravenously.
Slovenian: Zdravilo Remsima je treba dajati intravensko.
English: From a microbiological point of view, the infusion solution should be administered immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Slovenian: mikrobiološkega stališča je treba raztopino za infundiranje uporabiti takoj, za čas in pogoje shranjevanja pred uporabo je odgovoren uporabnik in navadno to ne bi smelo presegati 24 ur pri temperaturi 2°C - 8°C, razen če je rekonstitucija/redčenje potekala(o) v nadzorovanih in validiranih aseptičnih pogojih.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions (see section 6.3 above).
Slovenian: Če je ne uporabite takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik in navadno to ne bi smelo presegati 24 ur pri temperaturi med 2 °C - 8 °C, razen če je rekonstitucija/redčenje potekala(o) v nadzorovanih in validiranih aseptičnih pogojih (glejte poglavje 6.3 zgoraj).
English: • Tell your doctor straight away if you have signs of an infection.
Slovenian: Zdravniku morate takoj povedati, če imate znake, ki kažejo na okužbo.
English: Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI <150) vs. 1/25 (4%) of placebo-treated patients.
Slovenian: Prav tako so v 4. tednu pri 13 od 27 bolnikov (48 %), zdravljenih z infliksimabom, dosegli klinično remisijo (CDAI < 150), v primerjavi z 1 od 25 bolnikov (4 %), ki so prejeli placebo.
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis (see section 4.4).
Slovenian: Najpogosteje prijavljene oportunistične okužbe s stopnjo smrtnosti > 5 % so bile pnevmocistoza, kandidiaza, listerioza in aspergiloza (glejte poglavje 4.4).
English: This medicine contains 45 mg sorbitol in each 120 mg dose.
Slovenian: To zdravilo vsebuje 45 mg Sorbitola na en 120-mg odmerek.
English: Table 1 Adverse reactions in clinical studies and from post-marketing experience of intravenous infliximab
Slovenian: Neželeni učinki v kliničnih študijah in iz obdobja trženja intravenskega infliksimaba
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
Slovenian: • resne težave z živčevjem, na primer transverzni mielitis, multipli sklerozi podobna bolezen, vnetje vidnega živca in Guillain-Barréjev sindrom
English: In the Phase IIIb trial in Crohn's disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Slovenian: IIIb faze SONIC pri bolnikih s Crohnovo boleznijo, so bolniki iz placebo skupine, poleg placebo infuzij infliksimaba, prejemali kot kontrolno učinkovino AZA v odmerku 2,5 mg/kg na dan.
English: • Tell your doctor before you are given Remsima if you have or have ever had a problem that affects your nervous system.
Slovenian: • Preden prejmete zdravilo Remsima, povejte zdravniku, če imate ali ste kdaj prej že imeli kakršne koli nevrološke težave.
English: • Signs of a nervous system problem (including eye problems) such as fits, tingling or numbness in any part of your body, weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
Slovenian: • znaki težav z živčevjem (vključno s težavami z očmi), na primer epileptični napadi, mravljinci ali občutek odrevenelosti v kateremkoli delu telesa, šibkost rok ali nog, spremembe vida, na primer dvojni vid ali druge težave z očmi.
English: For intravenous use after reconstitution and dilution
Slovenian: intravenska uporaba po rekonstituciji in redčenju.
English: e
Slovenian: O
English: In the RA patients, the mean (± standard deviation) clearance of Remsima 120 mg subcutaneously was 18.8 ± 8.3 mL/hr at steady state.
Slovenian: Pri bolnikih z RA je mediana (± standardni odklon) navideznega očistka subkutano danega zdravila Remsima 120 mg znašala 18,8 ± 8,3 ml/uro v dinamičnem ravnovesju.
English: Almost all patients had also received medicines containing azathioprine or mercaptopurine in addition to TNF-blockers.
Slovenian: Skoraj vsi bolniki so poleg zaviralcev TNF prejeli tudi zdravila, ki vsebujejo azatioprin ali merkaptopurin.
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
English: Remsima subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
Slovenian: Zdravilo Remsima za subkutano uporabo ni indicirano za intravensko dajanje, zato jo je treba odmerjati izključno s subkutanim injiciranjem.
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 poznanih dejavnikov, ki bi lahko poslabšali stanje.
English: Proportions of Patients Achieving Clinical Response According to the ACR Criteria ACR20
Slovenian: Deleži bolnikov, ki so po merilih ACR dosegli klinični odziv
English: Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate.
Slovenian: Bolnike poučite o potencialnih dejavnikih tveganja za okužbe in jim svetujte, naj se izogibajo izpostavljanju le-tem.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo Remsima vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni “brez natrija”.