FrancophonIA/ELRC3.0 huggingface dataset:
English: The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild.
Slovenian: Neželeni učinki pri bolnikih z juvenilnim idiopatskim artritisom so bili po vrstah in deležih podobni tistim, opisanim v preskušanjih zdravila Enbrel pri odraslih bolnikih z revmatoidnim artritisom.
English: Look for the needle tip inside the stopper window (see Diagram 3).
Slovenian: Skozi okence v zamašku preverite, ali vidite konico igle (glejte sliko 3).
English: CARTON TEXT - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
Slovenian: BESEDILO NA ŠKATLI - EU/1/99/126/016-018 (50 mg napolnjena injekcijska brizga)
English: • The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 17).
Slovenian: Za injiciranje zdravila Enbrel so priporočljiva tri injekcijska mesta: (1) na sredini sprednjega dela stegna; (2) na trebuhu, razen v predelu 5 cm okrog popka; in (3) na zunanjem delu nadlakti (glejte sliko 17).
English: • Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
Slovenian: težave pri požiranju ali dihanju; otekanje obraza, žrela, rok ali nog; občutek živčnosti ali tesnobe, utripajoč občutek, nenadna pordelost kože in/ali občutek toplote;
English: • The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 9).
Slovenian: Za injiciranje zdravila Enbrel so priporočljiva tri injekcijska mesta: (1) na sredini sprednjega dela stegna; (2) na trebuhu, razen v predelu 5 cm okrog popka; in (3) na zunanjem delu nadlakti (glejte sliko 9).
English: After preparing the Enbrel solution, immediate use is recommended.
Slovenian: Priporočljivo je, da pripravljeno raztopino zdravila Enbrel nemudoma uporabite.
English: Enbrel 25 mg solution for injection in pre-filled syringe Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (solution for injection).
Slovenian: Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Enbrel je na voljo v napolnjeni injekcijski brizgi, ki vsebuje bistro, brezbarvno do bledo rumeno oziroma bledo rjavo raztopino za injiciranje (raztopino za injiciranje).
English: The following instructions explain how to prepare and inject Enbrel.
Slovenian: V tem navodilu sta opisana priprava in dajanje injekcij zdravila Enbrel.
English: Pfizer Luxembourg SARL filiāle Latvijā
Slovenian: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
English: Enbrel 25 mg solution for injection in pre-filled syringe Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
Slovenian: Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Injekcijska brizga iz prozornega stekla (steklo tipa I) z iglo iz nerjavečega jekla, gumijastim pokrovčkom igle in plastičnim batom.
English: CARTON TEXT - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
Slovenian: BESEDILO NA ŠKATLI - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg napolnjena injekcijska brizga)
English: • Congestive heart failure: Tell your doctor if the child has a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
Slovenian: Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri otroku kdaj pojavilo kongestivno srčno popuščanje.
English: • Leave the syringe in place.
Slovenian: Brizgo pustite v viali.
English: • Chickenpox: Tell your doctor if the child is exposed to chickenpox when using Enbrel.
Slovenian: Norice: Povejte zdravniku, če je bil otrok med zdravljenjem z zdravilom Enbrel izpostavljen noricam.
English: Common ≥ 1/100 to
Slovenian: Pogosti ≥ 1/100 do < 1/10
English: Enbrel 50 mg solution for injection in pre-filled syringe Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (solution for injection).
Slovenian: Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Enbrel je na voljo v napolnjeni injekcijski brizgi, ki vsebuje bistro, brezbarvno do bledo rumeno oziroma bledo rjavo raztopino za injiciranje (raztopino za injiciranje).
English: Do not use this medicine after the expiry date which is stated on the carton and on the MYCLIC prefilled pen after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in na napolnjenem injekcijskem peresniku MYCLIC poleg oznake ''Uporabno do'' ali ''Upor.
English: Detailed instructions on how to inject Enbrel are provided in section 7, “Using the MYCLIC pre-filled pen to inject Enbrel”.
Slovenian: Podrobna navodila o injiciranju zdravila Enbrel so v poglavju 7 “Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila Enbrel”.
English: Powder: Mannitol, sucrose and trometamol.
Slovenian: Pomožne snovi v zdravilu Enbrel so: prašek: manitol, saharoza in trometamol.
English: Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
Slovenian: 138 bolnikov je prejemalo 25 mg odmerke zdravila Enbrel (na podlagi študij za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placeba subkutano dvakrat na teden 6 mesecev.
English: Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake ''Uporabno do'' ali ''Upor.
English: Step 1: Preparing for an Enbrel injection 1.
Slovenian: Korak 1: Priprava na injiciranje zdravila Enbrel
English: 12b
Slovenian: 6. mesec b
English: The Enbrel pre-filled pen is available in 25 mg and 50 mg strengths.
Slovenian: Napolnjena injekcijska brizga je na voljo v jakostih 25 mg in 50 mg.
English: Methotrexate
Slovenian: Odmerjanje
English: • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
Slovenian: Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri vas ali otroku kdaj pojavilo kongestivno srčno popuščanje.
English: Contact your doctor before using Enbrel if the needle cap will be handled by, or Enbrel will be given to, someone with a known or possible hypersensitivity (allergy) to latex.
Slovenian: Če bo s pokrovčkom igle rokovala ali zdravilo Enbrel dobivala oseba z znano ali možno preobčutljivostjo (alergijo) na lateks, se pred uporabo zdravila Enbrel posvetujte z zdravnikom.
English: Enbrel is reconstituted with 1 ml water for injections before use and administered by subcutaneous injection.
Slovenian: Pred uporabo in subkutanim injiciranjem zdravilo Enbrel rekonstituirajte v 1 ml vode za injekcije.
English: Talk to your doctor before taking Enbrel.
Slovenian: Pred začetkom uporabe zdravila Enbrel se posvetujte z zdravnikom.
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject Enbrel."
Slovenian: Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila Enbrel".
English: In a fourth study, the safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly vs 25 mg Enbrel administered twice weekly were evaluated in a double-blind, placebocontrolled study of 356 patients with active ankylosing spondylitis.
Slovenian: V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja zdravila Enbrel v odmerku 50 mg enkrat na teden (dve 25 mg subkutani injekciji) v primerjavi z dajanjem zdravila Enbrel v odmerku 25 mg dvakrat na teden.
English: Pairwise comparison p-values: * = p < 0.05 for comparisons of Enbrel vs. methotrexate, † = p < 0.05 for comparisons of Enbrel + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs. Enbrel.
Slovenian: Vrednosti p za primerjavo po parih: * = p < 0,05 za primerjavo zdravila Enbrel z metotreksatom, † = p < 0,05 za primerjavo kombinacije zdravilo Enbrel + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravilo Enbrel + metotreksat z zdravilom Enbrel.
English: Contents of the pack and other information Instructions for preparing and giving an injection of Enbrel (See overleaf)
Slovenian: Navodila za pripravo in dajanje injekcije zdravila Enbrel (glejte drugo stran navodila)
English: Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with Enbrel.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Enbrel, so poročali o primerih aktivne tuberkuloze, vključno z miliarno tuberkulozo in ekstrapulmonarno tuberkulozo.
English: Each vial of Enbrel contains 10 mg etanercept.
Slovenian: Ena viala zdravila Enbrel vsebuje 10 mg etanercepta.
English: Enbrel 25 mg powder for solution for injection
Slovenian: Enbrel 25 mg prašek za raztopino za injiciranje
English: Contents of the pack and other information Using the MYCLIC pre-filled pen to inject Enbrel (See overleaf)
Slovenian: Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila Enbrel (glejte drugo stran navodila)
English: EU/1/99/126/013 4 pre-filled syringes EU/1/99/126/014 8 pre-filled syringes EU/1/99/126/015 24 pre-filled syringes EU/1/99/126/026 12 pre-filled syringes
Slovenian: EU/1/99/126/013 4 napolnjene injekcijske brizge EU/1/99/126/014 8 napolnjenih injekcijskih brizg EU/1/99/126/015 24 napolnjenih injekcijskih brizg EU/1/99/126/026 12 napolnjenih injekcijskih brizg
English: Each vial of Enbrel 10 mg should be used on a single occasion in a single patient, and the remainder of the vial should be discarded.
Slovenian: Ena viala z zdravilom Enbrel 10 mg je namenjena za enkratno uporabo pri enem bolniku.
English: EU/1/99/126/016 2 pre-filled syringes EU/1/99/126/017 4 pre-filled syringes EU/1/99/126/018 12 pre-filled syringes
Slovenian: EU/1/99/126/016 2 napolnjeni injekcijski brizgi EU/1/99/126/017 4 napolnjene injekcijske brizge EU/1/99/126/018 12 napolnjenih injekcijskih brizg
English: Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Slovenian: Pri nekaterih bolnikih, ki so prejemali zdravilo Enbrel, se je pojavil kožni rak. Povejte zdravniku, če se pri vas ali otroku razvije kakšna sprememba videza kože ali rašče na koži.
English: Serious adverse reactions have also been reported for Enbrel.
Slovenian: Pri uporabi zdravila Enbrel so poročali tudi o pojavu resnih neželenih učinkov.
English: CARTON TEXT - EU/1/99/126/023-025 (25 mg Pre-filled Pen)
Slovenian: BESEDILO NA ŠKATLI - EU/1/99/126/023-025 (25 mg napolnjeni injekcijski peresnik)
English: 9c
Slovenian: 6. mesec c
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - EU/1/99/126/003-005
Slovenian: BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - EU/1/99/126/003-005
English: 28b a: p<0.001, Enbrel vs. placebo b: p = 0.002, Enbrel vs. placebo
Slovenian: ASAS 70 2 tedna 3 meseci 6 mesecev b a: p < 0,001, zdravilo Enbrel proti placebu b: p = 0,002, zdravilo Enbrel proti placebu
English: Enbrel 25 mg injection etanercept
Slovenian: Enbrel 25 mg injekcija etanercept subkutana uporaba
English: Purple needle safety shield
Slovenian: beli pokrovček igle vijolični varnostni ščit igle
English: Each vial of Enbrel 25 mg contains 25 mg of etanercept.
Slovenian: Ena viala zdravila Enbrel 25 mg vsebuje 25 mg etanercepta.
English: • Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Slovenian: Alergijske reakcije: Če se pri vas ali otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Enbrel in nemudoma obvestite zdravnika.
English: Preparing the injection site and injecting the Enbrel solution
Slovenian: Priprava mesta injiciranja in injiciranje raztopine zdravila Enbrel
English: The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.
Slovenian: Priporočeni odmerek je 25 mg zdravila Enbrel dvakrat na teden ali 50 mg enkrat na teden.
English: Cartons contain 4, 8, 12 or 24 pre-filled syringes of Enbrel and 4, 8, 12 or 24 alcohol swabs.
Slovenian: Škatle vsebujejo 4, 8, 12 ali 24 napolnjenih injekcijskih brizg zdravila Enbrel in 4, 8, 12 ali 24 alkoholnih blazinic.
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with Enbrel (see section 4.8).
Slovenian: Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom (JIA), ki so se zdravili z zdravilom Enbrel, so poročali o primerih KVČB.
English: 25 mg Enbrel administered twice weekly is the recommended dose.
Slovenian: Priporočeni odmerek je 25 mg zdravila Enbrel dvakrat na teden.
English: • Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Slovenian: Alergijske reakcije: Če se pri otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Enbrel in nemudoma obvestite zdravnika.
English: CARTON TEXT - EU/1/99/126/019-021 (50 mg Pre-filled Pen)
Slovenian: BESEDILO NA ŠKATLI - EU/1/99/126/019-021 (50 mg napolnjeni injekcijski peresnik)
English: • You will also need the following items: A sterile syringe and needle(s) of 25 gauge x 16 mm or similar A vial or ampoule of water for injections 2 alcohol swabs
Slovenian: sterilno injekcijsko brizgo in iglo(e) velikosti 25 x 16 mm ali podobno,
English: Preparing the injection site and injecting the Enbrel solution h. Disposing of supplies a.
Slovenian: Priprava mesta injiciranja in injiciranje raztopine zdravila Enbrel h.
English: Enbrel 50 mg solution for injection in pre-filled syringe The active substance in Enbrel is etanercept.
Slovenian: Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Učinkovina zdravila Enbrel je etanercept.
English: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Slovenian: Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Enbrel in nemudoma obvestite zdravnika.
English: Enbrel 25 mg solution for injection in pre-filled syringe Enbrel 50 mg solution for injection in pre-filled syringe
Slovenian: Enbrel 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Enbrel 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Enbrel 25 mg solution for injection in pre-filled syringe The active substance in Enbrel is etanercept.
Slovenian: Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Učinkovina zdravila Enbrel je etanercept.
English: The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes, or particles.
Slovenian: Raztopina mora biti bistra in brezbarvna do bledo rumena oziroma bledo rjava ter ne sme vsebovati kepic, kosmičev ali delcev.
English: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.
Slovenian: Če se pri otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Enbrel in nemudoma obvestite zdravnika.
English: Each pack contains 4, 8, 12 or 24 pre-filled syringes and 4, 8, 12 or 24 alcohol swabs.
Slovenian: Eno pakiranje vsebuje 4, 8, 12 ali 24 napolnjenih injekcijskih brizg in 4, 8, 12 ali 24 alkoholnih blazinic.
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
Slovenian: Vrednosti p za primerjavo po parih: † = p < 0,05 za primerjavo kombinacije zdravila Enbrel + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravila Enbrel + metotreksat z zdravilom Enbrel.
English: Enbrel 25 mg solution for injection in pre-filled syringe EU/1/99/126/013
Slovenian: Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/99/126/013
English: Enbrel 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Slovenian: Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta.
English: See section 5 for instructions on how to store Enbrel.
Slovenian: Za navodila o shranjevanju zdravila Enbrel glejte poglavje 5.
English: These include the alcohol swab from the Enbrel carton and a cotton ball or gauze.
Slovenian: Pripravite si še druge stvari, ki jih boste potrebovali pri injiciranju, to sta alkoholna blazinica iz škatle z zdravilom Enbrel in košček vate ali gaze.
English: Enbrel 50 mg solution for injection in pre-filled syringe EU/1/99/126/016
Slovenian: Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/99/126/016
English: EXP
Slovenian: HAQ
English: Tell your doctor if the child develops any change in the appearance of the skin or growths on the skin.
Slovenian: Pri nekaterih bolnikih, ki so prejemali zdravilo Enbrel, se je pojavil kožni rak. Povejte zdravniku, če se pri otroku razvije kakšna sprememba videza kože ali rašče na koži.
English: Enbrel 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Slovenian: Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta.
English: Enbrel 25 mg powder for solution for injection Etanercept
Slovenian: Enbrel 25 mg prašek za raztopino za injiciranje etanercept
English: Detailed instructions on how to prepare and inject Enbrel are provided in section 7, “Instructions for preparing and giving an injection of Enbrel”.
Slovenian: Podrobna navodila o pripravi in injiciranju zdravila Enbrel so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila Enbrel”.
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Slovenian: Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA ENBREL".
English: The solution should be clear to slightly opalescent, colourless to pale yellow or pale brown and may contain small translucent or white particles of protein.
Slovenian: Raztopina mora biti bistra do rahlo opalescentna, brezbarvna do bledo rumena oziroma bledo rjava ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
English: Detailed instructions on how to inject Enbrel are provided in section 7, “Instructions for preparing and giving an injection of Enbrel”.
Slovenian: Podrobna navodila o injiciranju zdravila Enbrel so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila Enbrel”.
English: In this study most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower and few patients had two-fold rises in titres compared to patients not receiving Enbrel.
Slovenian: Večina bolnikov s psoriatičnim artritisom, ki so dobivali zdravilo Enbrel, je v tej študiji zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT - EU/1/99/126/002
Slovenian: BESEDILO NA NALEPKI VIALE - EU/1/99/126/002
English: Enbrel 10 mg powder and solvent for solution for injection for paediatric use etanercept
Slovenian: Enbrel 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih etanercept
English: Each pre-filled syringe of Enbrel contains 50 mg etanercept.
Slovenian: Ena napolnjena injekcijska brizga zdravila Enbrel vsebuje 50 mg etanercepta.
English: Each pre-filled syringe of Enbrel contains 25 mg etanercept.
Slovenian: Ena napolnjena injekcijska brizga zdravila Enbrel vsebuje 25 mg etanercepta.
English: Enbrel 25 mg solution for injection in pre-filled pen EU/1/99/126/023
Slovenian: Enbrel 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/99/126/023
English: Enbrela
Slovenian: Dojenje
English: Enbrel 10 mg powder and solvent for solution for injection for paediatric use
Slovenian: Enbrel 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih
English: Each vial of Enbrel contains 25 mg etanercept.
Slovenian: Ena viala zdravila Enbrel vsebuje 25 mg etanercepta.
English: Cartons contain 2, 4 or 12 pre-filled syringes of Enbrel with 2, 4 or 12 alcohol swabs.
Slovenian: Škatle vsebujejo 2, 4 ali 12 napolnjenih injekcijskih brizg zdravila Enbrel in 2, 4 ali 12 alkoholnih blazinic.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - EU/1/99/126/022 (For paediatric use)
Slovenian: BESEDILO NA NALEPKI INJEKCIJSKE BRIZGE - EU/1/99/126/022 (za uporabo pri otrocih)
English: Choosing an injection site h. Preparing the injection site and injecting the Enbrel solution i.
Slovenian: Priprava mesta injiciranja in injiciranje raztopine zdravila Enbrel i.
English: Enbrel did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Slovenian: Tudi pri opicah cynomolgus, ki so subkutano prejemale odmerek 15 mg/kg 2-krat tedensko 4 ali 26 tednov zapored, zdravilo Enbrel ni povzročilo toksičnosti, ki bi omejevala višino odmerka, niti toksičnosti za tarčne organe.
English: EU/1/99/126/019 2 pre-filled pens EU/1/99/126/020 4 pre-filled pens EU/1/99/126/021 12 pre-filled pens
Slovenian: EU/1/99/126/019 2 napolnjena injekcijska peresnika EU/1/99/126/020 4 napolnjeni injekcijski peresniki EU/1/99/126/021 12 napolnjenih injekcijskih peresnikov
English: Each MYCLIC pre-filled pen contains 25 mg of etanercept.
Slovenian: En napolnjeni injekcijski peresnik MYCLIC vsebuje 25 mg etanercepta.
English: Each pack contains 4, 8 or 24 pens and 4, 8 or 24 alcohol swabs.
Slovenian: Eno pakiranje vsebuje 4, 8 ali 24 injekcijskih peresnikov in 4, 8 ali 24 alkoholnih blazinic.
English: Enbrel 50 mg solution for injection in pre-filled syringe etanercept
Slovenian: Enbrel 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept
English: EU/1/99/126/023 4 pre-filled pens EU/1/99/126/024 8 pre-filled pens EU/1/99/126/025 24 pre-filled pens
Slovenian: EU/1/99/126/023 4 napolnjeni injekcijski peresniki EU/1/99/126/024 8 napolnjenih injekcijskih peresnikov EU/1/99/126/025 24 napolnjenih injekcijskih peresnikov
English: A 25 mg strength of Enbrel is available for doses of 25 mg.
Slovenian: Predpisali so vam zdravilo Enbrel v jakosti 50 mg. Za 25 mg odmerek je na voljo zdravilo Enbrel jakosti 25 mg.
English: Enbrel 50 mg solution for injection in pre-filled pen EU/1/99/126/019
Slovenian: Enbrel 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/99/126/019