FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received LIFMIOR were observed compared with younger patients.
Slovenian: V študijah 3. faze pri revmatoidnem artritisu, psoriatičnem artritisu in ankilozirajočem spondilitisu pri bolnikih, starih 65 let ali več, ki so prejeli zdravilo LIFMIOR, na splošno niso opazili nobenih razlik glede neželenih učinkov, resnih neželenih učinkov in resnih okužb v primerjavi z mlajšimi bolniki.
English: Both TNFRs exist naturally in membrane-bound and soluble forms.
Slovenian: Oboji receptorji v naravi obstajajo v dveh oblikah, tj. vezani na membrano in v topni obliki.
English: Dimeric soluble receptors such as etanercept possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors.
Slovenian: Topni dimerni receptorji, kot je etanercept, imajo večjo afiniteto za TNF kot monomerni receptorji in so veliko bolj učinkoviti kompetitivni antagonisti vezave TNF na celične receptorje.
English: The proportion of patients treated with LIFMIOR who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Slovenian: Delež bolnikov, ki so razvili protitelesa proti kardiolipinu, je bil podobno povečan pri zdravilu LIFMIOR v primerjavi s placebom.
English: All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, paleness) whilst on LIFMIOR, they should seek immediate medical advice.
Slovenian: Vse bolnike in starše/skrbnike je treba opozoriti, da morajo pri bolniku v primeru pojava znakov ali simptomov, ki kažejo na krvno diskrazijo ali okužbo (npr. trdovratna zvišana telesna temperatura, vnetje žrela, podplutbe, krvavitve, bledica), med zdravljenjem s tem zdravilom takoj poiskati zdravniško pomoč.
English: LIFMIOR treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Slovenian: Zdravljenje z zdravilom LIFMIOR lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa, juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, radiografsko nezaznavnega aksialnega spondilartritisa, psoriaze v plakih ali otroške psoriaze v plakih.
English: Patients in the LIFMIOR in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Slovenian: Pri bolnikih, ki so prejemali zdravilo LIFMIOR v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS - Disease Activity Score) in HAQ tako po 24 kot po 52 tednih statistično pomembno večji kot pri bolnikih, ki so jih zdravili z enim samim zdravilom (izsledki so povzeti v spodnji preglednici).
English: • Latex: The needle cap of the MYCLIC pen is made from latex (dry natural rubber).
Slovenian: Lateks: Pokrovček igle peresnika MYCLIC je izdelan iz lateksa (suhega naravnega kavčuka).
English: In the double-blind period, patients received LIFMIOR 50 mg weekly or placebo for 12 weeks.
Slovenian: V dvojno slepem obdobju so bolniki prejemali zdravilo LIFMIOR v odmerku 50 mg na teden ali placebo 12 tednov.
English: Pyrexia
Slovenian: pireksija
English: The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex).
Slovenian: Pokrovček igle napolnjenega injekcijskega peresnika vsebuje posušen naravni kavčuk (derivat lateksa).
English: Clear glass vial (4 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps.
Slovenian: Viala iz prozornega stekla (4 ml, steklo tipa I) z gumijastim zamaškom, aluminijastim obročkom in plastično zaporko (tipa "flip-off").
English: ACR 20 Month 3
Slovenian: ACR 20 3. mesec 6. mesec
English: In the postmarketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists.
Slovenian: V obdobju trženja so pri bolnikih, zdravljenih z antagonisti TNF, poročali o primerih levkemije.
English: • Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue
Slovenian: • znaki lupusa ali lupusu podobnega sindroma, kot so spremembe telesne mase, trdovraten kožni izpuščaj, vročina, bolečina v sklepih ali mišicah ali utrujenost;
English: • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 18).
Slovenian: S hitrim in kratkim gibom potisnite iglo do konca v kožo pod kotom 45 do 90 stopinj (glejte sliko 18).
English: Disease flare was defined as a ≥ 30% worsening in three of six JRA core set criteria and ≥ 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Slovenian: Ponoven izbruh bolezni je bil definiran kot  30 % poslabšanje treh od šestih osnovnih kazalcev JRA in  30 % izboljšanje največ enega od šestih glavnih kazalcev JRA ter najmanj dva aktivno prizadeta sklepa.
English: If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose.
Slovenian: Če ste na predvideni odmerek zdravila LIFMIOR pozabili, ga morate injicirati takoj, ko se spomnite, razen če je naslednji odmerek predviden za naslednji dan.
English: Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Slovenian: tuberkuloza, oportunistična okužba (vključno z invazivnimi glivičnimi, protozojskimi, bakterijskimi, atipičnimi mikobakterijskimi, virusnimi okužbami in okužbami z bakterijo Legionella)*
English: • Vaccinations: If possible, children should be up to date with all vaccinations before using LIFMIOR.
Slovenian: • Cepljenja: Najbolje je, da otrok pred začetkom zdravljenja z zdravilom LIFMIOR opravi vsa predvidena cepljenja.
English: With the other hand, push STRAIGHT DOWN FIRMLY on the adaptor package until you feel the adaptor spike penetrate the vial stopper and FEEL AND HEAR THE ADAPTOR RIM LOCK INTO PLACE (see Diagram 3).
Slovenian: Z drugo roko MOČNO pritisnite embalažo z adapterjem NARAVNOST NAVZDOL, dokler ne začutite, da je konica adapterja predrla gumijasti zamašek viale in OBČUTITE TER SLIŠITE, da je ADAPTER NAMEŠČEN (glejte sliko 3).
English: ACR 20 and 50 responses were higher in patients treated with LIFMIOR at 3 and 6 months than in patients treated with placebo (ACR 20: LIFMIOR 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: LIFMIOR 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 LIFMIOR vs placebo at all timepoints for both ACR 20 and ACR 50 responses).
Slovenian: Odstotek bolnikov, ki so po 3 oziroma 6 mesecih dosegli odziv ACR 20 ali ACR 50, je bil v skupini bolnikov, ki so bili zdravljeni z zdravilom LIFMIOR, večji kot pri bolnikih, ki so prejemali placebo (ACR 20 po 3 oz. 6 mesecih: zdravilo LIFMIOR 62 % oz. 59 %, placebo 23 % oz. 11 %; ACR 50 po 3 oz. 6 mesecih: zdravilo LIFMIOR 41 % oz. 40 %, placebo 8 % oz. 5 %; p < 0,01 za zdravilo LIFMIOR proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
English: Undesirable effects in paediatric patients with juvenile idiopathic arthritis In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients (see below, Undesirable effects in adults).
Slovenian: Neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom Na splošno so bili neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom po vrsti in pogostnosti podobni tistim pri odraslih (glejte spodaj, Neželeni učinki pri odraslih).
English: 8 vials of powder
Slovenian: 8 vial s praškom
English: However, due to their transient nature, the incidence of antibodies detected at each assessment point was typically less than 7% in rheumatoid arthritis subjects and psoriasis subjects.
Slovenian: Vendar je bila pojavnost protiteles, odkritih ob vsakem periodičnem določanju, zaradi njihove začasne narave pri bolnikih z revmatoidnim artritisom in bolnikih s psoriazo manjša od 7 %.
English: The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with LIFMIOR compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with LIFMIOR compared to none of placebo-treated patients).
Slovenian: Tudi odstotek bolnikov, ki so razvili nova pozitivna avtoprotitelesa proti dvojno vijačni DNK, je bil večji, merjeno z radioimunskimi testi (15 % pri zdravilu LIFMIOR in 4 % pri placebu) in s testom na Crithidia luciliae (3 % pri zdravilu LIFMIOR in 0 % pri placebu).
English: Tell your doctor immediately, or go to the casualty department at your nearest hospital.
Slovenian: Nemudoma se posvetujte z zdravnikom ali pojdite v ambulanto za nujno pomoč najbližje bolnišnice.
English: If you are self injecting, you should not use the outer area of the upper arms.
Slovenian: Če si zdravilo injicirate sami, ne uporabljajte injekcijskega mesta na zunanjem delu nadlakti.
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after LIFMIOR treatment.
Slovenian: Vsem bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če se med zdravljenjem z zdravilom LIFMIOR ali po njem pojavijo znaki/simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hiranje/hujšanje, nekoliko zvišana telesna temperatura).
English: The combination LIFMIOR and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Slovenian: Ni dokazano, da bi bila kombinacija zdravila LIFMIOR in anakinre klinično koristnejša, zato ni priporočljiva.
English: In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Slovenian: Pri psoriazi v plakih se zaradi infiltracije vnetnih celic (vključno s celicami T) v psoriatičnih lezijah v primerjavi z neprizadeto kožo poveča koncentracija TNF.
English: These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice weekly.
Slovenian: Te povprečne koncentracije so bile podobne koncentracijam, ki so jih opazili pri odraslih bolnikih s psoriazo v plakih, zdravljenih s 25 mg etanercepta dvakrat na teden.
English: Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Slovenian: Pri bolniku, ki se v tem obdobju ne odziva, je treba skrbno razmisliti o nadaljevanju zdravljenja.
English: Study 1 was a Phase 2 study in patients with active, but clinically stable, plaque psoriasis involving ≥ 10% of the body surface area who were ≥ 18 years old.
Slovenian: Študija 1 je bila študija 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10 % površine telesa.
English: Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation*
Slovenian: Bolezni imunskega sistema alergijske reakcije (glejte Bolezni kože in podkožja), nastanek avtoprotiteles*
English: Instructions for preparing and giving an injection of LIFMIOR
Slovenian: Navodila za pripravo in dajanje injekcije zdravila LIFMIOR
English: Study 4
Slovenian: Študija 4
English: UNIQUE IDENTIFIER-2D BARCODE 2D barcode carrying the unique identifier included.
Slovenian: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: • Once the solvent is added to the LIFMIOR, the plunger may move up by itself.
Slovenian: Ko je vehikel dodan zdravilu LIFMIOR, se lahko zgodi, da se bat brizge sam pomakne navzgor.
English: Based on current knowledge, a possible risk for the development of lymphomas, leukaemia or other haematopoietic or solid malignancies in patients treated with a TNF-antagonist cannot be excluded.
Slovenian: Na podlagi trenutnih dognanj pri bolnikih, ki se zdravijo z antagonistom TNF, morebitnega tveganja za razvoj limfomov, levkemije ali drugih hematopoetičnih ali čvrstih rakavih obolenj ni mogoče izključiti.
English: Mean (SE) Annualized Change from Baseline in Total Sharp Score Placebo
Slovenian: Povprečna (SE) sprememba skupne Sharpove ocene od izhodišča na leto Placebo
English: There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with LIFMIOR from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4).
Slovenian: Viri iz obdobja trženja so poročali o kronični vnetni črevesni bolezni in uveitisu pri bolnikih z JIA, ki so se zdravili z zdravilom LIFMIOR, vključno z zelo majhnim številom primerov, ki kažejo na ponoven pojav bolezni ob naslednjem dajanju zdravila (glejte poglavje 4.4).
English: The LIFMIOR solution should not be mixed with any other medicine before use.
Slovenian: Raztopine zdravila LIFMIOR pred uporabo ne smete mešati z drugimi zdravili.
English: Serious infections experienced by LIFMIOR-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Slovenian: Med resnimi okužbami pri bolnikih, zdravljenih z zdravilom LIFMIOR, so bile celulitis, gastroenteritis, pljučnica, holecistitis, osteomielitis, gastritis, apendicitis, streptokokni fasciitis, miozitis, septični šok, divertikulitis in absces.
English: Step 1: Setting up for an injection Step 2: Choosing an injection site Step 3: Injecting the LIFMIOR solution Step 4: Disposing of supplies
Slovenian: Korak 1: Priprava na injiciranje Korak 2: Izbira mesta injiciranja Korak 3: Injiciranje raztopine zdravila LIFMIOR Korak 4: Odstranjevanje odpadkov
English: LIFMIOR is administered by subcutaneous injection.
Slovenian: Zdravilo LIFMIOR se daje s subkutano injekcijo.
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Slovenian: Stevens-Johnsonov sindrom, kožni vaskulitis (vključno s preobčutljivostnim vaskulitisom), multiformni eritem, lihenoidne reakcije toksična epidermalna nekroliza
English: Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution.
Slovenian: Dokazali so, da je rekonstituirano zdravilo med uporabo kemijsko in fizikalno stabilno 6 ur pri temperaturi do 25 C.
English: • Severe psoriasis in patients from the age of 6 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Slovenian: • za zdravljenje hude psoriaze pri bolnikih, starejših od 6 let, ki so se nezadostno odzvali na fototerapije ali druge sistemske terapije (ali jih niso prenašali).
English: In a polyarticular-course juvenile idiopathic arthritis trial with LIFMIOR, 69 patients (aged 4 to 17 years) were administered 0.4 mg LIFMIOR/kg twice weekly for three months.
Slovenian: V kliničnem preskušanju pri 69 bolnikih s poliartikularnim potekom juvenilnega idiopatskega artritisa, starih od 4 do 17 let, so injicirali 0,4 mg zdravila LIFMIOR/kg 2-krat tedensko v obdobju treh mesecev.
English: These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Slovenian: Med temi so bili abscesi (na različnih mestih), bakteriemija, bronhitis, burzitis, celulitis, holecistitis, diareja, divertikulitis, endokarditis (sum nanj), gastroenteritis, hepatitis B, herpes zoster, razjeda na nogi, okužba ustne votline, osteomielitis, otitis, peritonitis, pljučnica, pielonefritis, sepsa, septični artritis, sinuzitis, okužbe kože, kožne razjede, okužbe sečil, vaskulitis in okužbe ran.
English: Methotrexate (n = 228)
Slovenian: metotreksat (n = 231)
English: • Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
Slovenian: Rak lahko prizadene katerikoli del telesa, vključno s kožo in krvjo.
English: Adult patients with rheumatoid arthritis
Slovenian: Odrasli bolniki z revmatoidnim artritisom
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all LIFMIOR-treated subjects was 4.64 for the SIJ (n=153) and 1.40 the spine (n=154).
Slovenian: Pri vseh bolnikih, ki so prejemali zdravilo LIFMIOR, je po 104 tednih povprečna sprememba od izhodišča za rezultat SPARCC, merjen z magnetnoresonančnim slikanjem, znašala 4,64 za SIJ (n = 153) in 1,40 za hrbtenico (n = 154).
English: 24 vials of powder 24 pre-filled syringes of 1 ml solvent 24 stainless steel injection needles 24 vial adaptors
Slovenian: 24 vial s praškom24 napolnjenih injekcijskih brizg z 1 ml vehikla 24 igel iz nerjavečega jekla 24 adapterjev za viale
English: • Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 15).
Slovenian: S potegom naravnost proč od brizge odstranite pokrovček igle z injekcijske brizge in pri tem pazite, da se s prsti ne dotaknete igle in da se z iglo ne dotaknete ničesar (glejte sliko 15).
English: 8 pre-filled syringes of 1 ml solvent 8 stainless steel injection needles 8 vial adaptors
Slovenian: 8 napolnjenih injekcijskih brizg z 1 ml vehikla 8 igel iz nerjavečega jekla 8 adapterjev za viale
English: 6 When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Slovenian: Ko je brizga prazna, izvlecite iglo iz kože pod istim kotom, kot ste jo zabodli vanjo.
English: Pick up the pen, and remove the white needle cap by pulling it straight off (see Diagram 3).
Slovenian: Peresnik vzemite v roke in odstranite beli pokrovček igle, tako da ga potegnete naravnost proč (glejte sliko 3).
English: Before preparing the LIFMIOR solution, LIFMIOR may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
Slovenian: Pred pripravo raztopine zdravila LIFMIOR lahko zdravilo LIFMIOR shranjujete izven hladilnika pri temperaturi do največ 25 °C za enkratno obdobje do štirih tednov, po katerem se ga ne sme več ohladiti.
English: The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Slovenian: Neželeni učinki, o katerih so poročali najpogosteje, so: reakcije na mestu injiciranja (kot so bolečina, oteklina, srbenje, rdečina in krvavitev na mestu vboda), okužbe (kot so okužbe zgornjih dihal, bronhitis, okužbe sečnega mehurja in okužbe kože), alergijske reakcije, razvoj avtoprotiteles, srbenje in povišana telesna temperatura.
English: There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Slovenian: V obdobju trženja so poročali o pancitopeniji in aplastični anemiji, nekateri od teh primerov so bili tudi smrtni (glejte poglavje 4.4).
English: Etanercept has been reported to be excreted in human milk following subcutaneous administration.
Slovenian: Etanercept se pri človeku po subkutani uporabi izloča v materino mleko.
English: Powder: Mannitol (E421), sucrose and trometamol Solvent: Water for injections
Slovenian: Pomožne snovi so: prašek: manitol (E421), saharoza in trometamol; vehikel: voda za injekcije.
English: At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving LIFMIOR.
Slovenian: Pri bolnikih, ki so prejemali zdravilo LIFMIOR, je po 12 tednih prišlo do statistično pomembnega izboljšanja rezultata SPARCC (SPARCC - Spondyloarthritis Research Consortium of Canada; Kanadski konzorcij za raziskovanje spondilartritisa) za sakroiliakalni sklep (SIJ - Sacroiliac Joint), ki so ga merili z magnetnoresonančnim slikanjem.
English: However, your doctor may determine an alternative frequency at which to inject LIFMIOR.
Slovenian: Zdravnik vam lahko predpiše tudi drugačno pogostnost injiciranja zdravila LIFMIOR.
English: Uncommon ≥ 1/1,000 to < 1/100
Slovenian: Pogosti ≥ 1/100 do < 1/10
English: Instructions for preparing and giving an injection of LIFMIOR (See overleaf)
Slovenian: Navodila za pripravo in dajanje injekcije zdravila LIFMIOR (glejte drugo stran navodila)
English: There is generally no applicable use of LIFMIOR in children aged below 6 years in the indication plaque psoriasis.
Slovenian: Zdravila LIFMIOR se običajno ne uporablja za zdravljenje psoriaze v plakih pri otrocih, mlajših od 6 let.
English: Autoimmune hepatitis*
Slovenian: avtoimunski hepatitis*
English: Patients also had plaque psoriasis with a qualifying target lesion ≥ 2 cm in diameter.
Slovenian: Bolniki so imeli tudi psoriazo v plakih, pri čemer so za mejno velikost lezij šteli tiste z ≥ 2 cm premera.
English: • Infections/surgery: If the child develops a new infection, or is about to have any major surgery, the doctor may wish to monitor the child's treatment with LIFMIOR.
Slovenian: Okužbe/operacije: Če se pri otroku pojavi nova okužba ali če je pri otroku predvidena kakršnakoli večja operacija, bo zdravnik morda želel spremljati zdravljenje z zdravilom LIFMIOR.
English: Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks.
Slovenian: Bolniki z otroško psoriazo v plakih (stari od 4 do 17 let) so prejemali po 0,8 mg/kg (do največjega odmerka 50 mg na teden) etanercepta enkrat na teden do 48 tednov.
English: The 10 mg vial is for children prescribed a dose of 10 mg or less.
Slovenian: 10 mg viala je namenjena za uporabo pri otrocih s predpisanim odmerkom 10 mg ali manj.
English: A higher rate of major birth defects was observed in one observational study comparing pregnancies exposed to etanercept (n=370) during the first trimester with pregnancies not exposed to etanercept or other TNF-antagonists (n=164) (adjusted odds ratio 2.4, 95% CI: 1.0-5.5).
Slovenian: V 1 opazovalni študiji, kjer so primerjali nosečnosti, izpostavljene etanerceptu (n = 370) v prvem trimesečju, z nosečnostmi, ki niso bile izpostavljene etanerceptu ali drugim antagonistom TNF (n = 164), so opazili večji delež resnih prirojenih napak (prilagojeno razmerje obetov 2,4, 95 % IZ: 1,0-5,5).
English: Some patients have developed a reaction at an injection site that was used before.
Slovenian: Pri nekaterih bolnikih se je reakcija pojavila na mestu predhodnega injiciranja.
English: • Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.
Slovenian: • znaki vnetja krvnih žil, kot so bolečina, vročina, rdečina ali toplina kože ali srbenje.