FrancophonIA/ELRC3.0 huggingface dataset:
English: You must look out for signs of these conditions while you are taking Tremfya.
Slovenian: V času prejemanja zdravila Tremfya morate biti pozorni na znake takih težav.
English: Tremfya 100 mg solution for injection in pre-filled pen 1 mL solution in a pre-filled glass syringe assembled in a pre-filled pen with an automatic needle guard.
Slovenian: Tremfya 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 ml raztopine v napolnjeni stekleni brizgi, vstavljeni v napolnjen injekcijski peresnik z avtomatskim varovalom igle.
English: CARTON FOR PRE-FILLED SYRINGE MULTIPACK COMPRISING 2 PACKS (INCLUDING BLUE BOX)
Slovenian: BESEDILO NA ŠKATLI Z VEČJIM PAKIRANJEM, KI VSEBUJE 2 NAPOLNJENA INJEKCIJSKA PERESNIKA (VKLJUČNO Z MODRIM OKENCOM)
English: Call your doctor or pharmacist for a refill.
Slovenian: Pokličite zdravnika ali farmacevta, da vam zdravilo zamenja z novim.
English: Major Secondary Endpoints PASI 75 response at both Week 12 and Week 48
Slovenian: primarni cilj opazovanja odziv PASI 90 v 48. tednu glavni sekundarni cilji opazovanja odziv PASI 75 v 12. tednu in v
English: Figure 2: Percent of Subjects Who Achieved a PASI 90 Response by Visit in the Open-Label Phase in VOYAGE 1
Slovenian: Slika 2: Odstotek preiskovancev, ki so dosegli odziv PASI 90 od 52. do 156. tedna po posameznih obiskih v odprti fazi študije VOYAGE 1
English: Inspect liquid
Slovenian: Študija ECLIPSE
English: After removing the pre-filled syringe or pre-filled pen from the refrigerator, keep the pre-filled syringe or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes before injecting Tremfya.
Slovenian: Ko vzamete napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik iz hladilnika, ju pustite v škatli in pred injiciranjem zdravila Tremfya počakajte 30 minut, da zdravilo doseže sobno temperaturo.
English: The safety guard will cover the needle and lock into place, removing the needle from your skin.
Slovenian: Prenehajte pritiskati na bat Varnostni ščitnik bo potegnil iglo iz kože, jo pokril in se zaskočil.
English: Renal elimination of intact guselkumab, an IgG mAb, is expected to be low and of minor importance; similarly, hepatic impairment is not expected to influence clearance of guselkumab as IgG mAbs are mainly eliminated via intracellular catabolism.
Slovenian: Podobno tudi okvara jeter predvidoma ne vpliva na izločanje guselkumaba iz telesa, ker se monoklonska protitelesa IgG izločajo predvsem z znotrajceličnim katabolizmom.
English: Multipack: 2 (2 packs of 1) pre-filled syringes
Slovenian: Večje pakiranje: 2 napolnjeni ijnekcijski brizgi (2 pakiranji po 1 napolnjeno injekcijsko brizgo)
English: Before use, remove the carton from the refrigerator and keep the pre-filled syringe inside the carton and allow to reach room temperature by waiting for 30 minutes.
Slovenian: Pred uporabo vzemite škatlo iz hladilnika in napolnjen injekcijski peresnik pustite v škatli ter počakajte 30 minut, da zdravilo doseže sobno temperaturo.
English: Put your used syringe in a sharps disposal container right away after use.
Slovenian: Zavrzite uporabljen napolnjen injekcijski peresnik Uporabljen napolnjen injekcijski peresnik takoj po uporabi odložite v posodo za odstranjevanje ostrih predmetov.
English: Levels of IL-23 are elevated in the skin of patients with plaque psoriasis.
Slovenian: Pri bolnikih s psoriazo s plaki je koncentracija IL-23 v koži povečana.
English: What Tremfya looks like and contents of the pack Solution for injection (injection).
Slovenian: Izgled zdravila Tremfya in vsebina pakiranja
English: b, n (%) Week 16 21 (14.5) hf-PGA (N) hf-PGA 0/1
Slovenian: hf-PGA (N) hf-PGA 0/1
English: Skin and subcutaneous tissue disorders Common
Slovenian: Bolezni kože in podkožja pogosti urtikarija občasni izpuščaj
English: Tremfya is available in a pack containing one pre-filled syringe and in a multipack containing 2 (2 packs of 1) pre-filled syringes.
Slovenian: Zdravilo Tremfya je na voljo v pakiranju, ki vsebuje en napolnjen injekcijski peresnik in v večjem pakiranju, ki vsebuje 2 napolnjena injekcijska peresnika (2 pakiranji po 1 injekcijski peresnik).
English: p < 0.001 for superiority p < 0.001 for non-inferiority, p=0.062 for superiority formal statistical testing was not performed
Slovenian: 48. tednu odziv PASI 75 v 12. tednu odziv PASI 90 v 12. tednu odziv PASI 100 v 48. tednu p < 0,001 za superiornost p < 0,001 za neinferiornost, p=0,062 za superiornost formalno statistično testiranje ni bilo izvedeno
English: Insert needle with a quick, dart-like motion.
Slovenian: Iglo potisnite v kožo s hitrim sunkovitim gibom.
English: Histidine monohydrochloride monohydrate Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi histidin histidinijev klorid monohidrat polisorbat 80 saharoza voda za injekcije
English: Tremfya 100 mg solution for injection in pre-filled syringe guselkumab
Slovenian: Tremfya 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku guselkumab
English: PASI 90 response at Week 48
Slovenian: 48. teden PASI 75 PASI 90 PASI
English: Symptom score = 0, n (%)
Slovenian: ocena simptomov PSSD, preiskovanci z izhodiščno oceno > 0 ocena simptomov = 0, n (%)
English: Talk to your doctor, pharmacist or nurse before using Tremfya:
Slovenian: Pred začetkom uporabe zdravila Tremfya se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: • The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin
Slovenian: • Prvi odmerek 100 mg (vsebino enega napolnjenega injekcijskega peresnika) boste prejeli s podkožno injekcijo (subkutano), ki vam jo bo injiciral vaš zdravnik ali medicinska sestra.
English: (subcutaneous injection).
Slovenian: Raztopina za injiciranje (injekcija).
English: SINGLE-USE DEVICE
Slovenian: ZA ENKRATNO UPORABO
English: If you are uncertain, call your doctor or pharmacist for a refill.
Slovenian: Če ste v dvomu, pokličite zdravnika ali farmacevta, da vam zdravilo zamenja z novim.
English: Please read these Instructions for use before using the Tremfya pre-filled syringe and each time you get a refill.
Slovenian: Pred uporabo napolnjene injekcijske brizge zdravila Tremfya in vsakokrat, ko obnovite zalogo zdravil, preberite to Navodilo za injiciranje.
English: The improvements in SF-36, HADS and WLQ were all maintained through Week 48 and in the open-label phase through Week 156 among patients randomised to maintenance therapy at Week 28.
Slovenian: Pri bolnikih, ki so bili v 28. tednu randomizirani na vzdrževalno zdravljenje, so izboljšanja ocen pri vseh treh vprašalnikih (SF-36, HADS in WLQ) vztrajala do konca 48. tedna in pri odpti fazi študije do 156. tedna.
English: Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Slovenian: Ko bo posoda za odstranjevanje ostrih predmetov polna, poskrbite, da jo boste zavrgli v skladu z navodili zdravnika ali medicinske sestre.
English: Your injection is now complete!
Slovenian: S tem ste zaključili injiciranje.
English: Each pre-filled syringe contains 100 mg of guselkumab in
Slovenian: Ena napolnjena injekcijska brizga vsebuje 100 mg guselkumaba v
English: Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: The systemic exposure of guselkumab (Cmax and AUC) increased in an approximately dose-proportional manner following a single subcutaneous injection at doses ranging from 10 mg to 300 mg in healthy subjects or patients with plaque psoriasis.
Slovenian: Po enkratni subkutani injekciji odmerkov od 10 mg do 300 mg se je pri zdravih preiskovancih in pri bolnikih s psoriazo s plaki sistemska izpostavljenost guselkumabu (Cmax in AUC) povečevala približno sorazmerno z odmerkom.
English: Do not use the Tremfya pre-filled syringe if it is dropped.
Slovenian: Če vam napolnjena injekcijska brizga z zdravilom Tremfya pade iz rok, je ne uporabite.
English: Do not inject if perforations on the carton are broken.
Slovenian: Če je perforacija na škatli pretrgana, ne injicirajte zdravila.
English: However, you may decide together with your doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject Tremfya.
Slovenian: Skupaj z zdravnikom se lahko odločita, da si boste zdravilo Tremfya injicirali sami.
English: Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails.
Slovenian: Psoriaza s plaki je vnetna bolezen, ki prizadane kožo in nohte.
English: Instructions for use Tremfya
Slovenian: Shranjevanje zdravila Tremfya
English: What Tremfya contains - The active substance is guselkumab.
Slovenian: • Učinkovina je guselkumab.
English: The yellow band indicates that the needle guard is locked.
Slovenian: zeleno telo okence pokrovček peresnika varovalo igle držalo
English: PRE-FILLED SYRINGE LABEL TEXT (100 mg)
Slovenian: BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE (100 mg)
English: Do not use if the expiration date has passed.
Slovenian: Če je rok uporabnosti potekel, zdravila ne uporabite.
English: Do not shake the pre-filled syringe at any time.
Slovenian: Napolnjene injekcijske brizge nikoli ne stresajte.
English: Each pre-filled pen contains 100 mg of guselkumab in
Slovenian: En napolnjen injekcijski peresnik vsebuje 100 mg guselkumaba v
English: Tremfya 100 mg injection guselkumab SC
Slovenian: Tremfya 100 mg injekcija guselkumab s.c.
English: Summary of Clinical Responses in VOYAGE 1 and VOYAGE 2 Number of patients (%)
Slovenian: Preglednica 2:Povzetek kliničnih odzivov v študijah VOYAGE 1 in VOYAGE 2
English: Some cases occurred several days after treatment with guselkumab, including cases with urticaria and dyspnoea.
Slovenian: V nakaterih primerih, vključno z urtikarijo in dispnejo, je do preobčutljivostne reakcije prišlo več dni po zdravljenju z guselkumabom.
English: Position fingers and insert needle
Slovenian: opazovalno okence pokrovček za iglo
English: Anti-TB therapy should be considered prior to initiating Tremfya in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Slovenian: Pri bolnikih, z latentno ali aktivno tuberkulozo v anamnezi, ki nimajo dokumentiranega ustreznega poteka zdravljenja, je treba pred začetkom zdravljenja z zdravilom Tremfya razmisliti o zdravljenju tuberkuloze.
English: Please read these Instructions for use before using the Tremfya pre-filled pen and each time you get a new pre-filled pen.
Slovenian: Pred uporabo napolnjenega injekcijskega peresnika z zdravilom Tremfya in vsakokrat, ko dobite nov napolnjen injekcijski peresnik, preberite to Navodilo za injiciranje.
English: It is supplied as a carton pack containing one single-dose glass syringe and as a multipack containing 2 (2 packs of 1) single-dose pre-filled syringes.
Slovenian: Na voljo je v škatli, ki vsebuje eno stekleno injekcijsko brizgo za enkratno odmerjanje in v večjem pakiranju, ki vsebuje 2 napolnjeni injekcijski brizgi za enkratno uporabo (2 pakiranji po 1 napolnjeno injekcijsko brizgo).
English: Diarrhoea
Slovenian: Cepljenja
English: In addition, reduced serum IL-17A, IL-17F and IL-22 levels compared to placebo were observed in guselkumab treated patients in phase II and phase III studies.
Slovenian: V isti študiji faze I je zdravljenje z guselkumabom omogočilo izboljšanje histoloških meril za psoriazo, ki so jih ocenjevali v 12. tednu in so vključevala zmanjšanje debeline epidermisa in gostote limfocitov T. Poleg tega so v študijah faze II in faze III pri bolnikih, ki so prejemali guselkumab, opazili manjše koncentracije IL-17A, IL-17F in IL-22 v serumu kot pri bolnikih s placebom.
English: Before injection
Slovenian: Pred injiciranjem bat
English: No new safety findings were observed in patients who switched from adalimumab to guselkumab.
Slovenian: Pri bolnikih, ki so prešli z adalimumaba na guselkumab, niso opazili nobenih novih ugotovitev v povezavi z varnostjo zdravila.
English: Do not pass it on to others.
Slovenian: Ne ogrevajte ga na noben drug način.
English: • Talk to your doctor if you are breast-feeding or are planning to breast-feed.
Slovenian: • Če dojite ali načrtujete dojenje, se posvetujte z zdravnikom.
English: 1 pre-filled pen
Slovenian: • 1 samolepilni obliž
English: Inject Tremfya using the pre-filled syringe
Slovenian: Injicirajte zdravilo Tremfya z napolnjeno injekcijsko brizgo
English: Each pre-filled syringe contains 100 mg of guselkumab in 1 mL.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 100 mg guselkumaba v 1 ml raztopine.
English: Keep hands away from the needle guard after the cap is removed.
Slovenian: Ko je pokrovček odstranjen, pazite, da se z rokami ne dotaknete varovala igle.
English: Do not lift the pre-filled pen during the injection.
Slovenian: Napolnjenega injekcijskega peresnika nikoli ne stresajte.
English: Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.
Slovenian: Če opazite katerekoli znake, ki bi lahko pomenili, da je prišlo do resne alergijske reakcije ali okužbe, prenehajte uporabljati zdravilo Tremfya in takoj obvestite zdravnika oziroma poiščite zdravniško pomoč.
English: The needle guard will lock and the full dose will not be delivered.
Slovenian: Med injiciranjem ne dvigujte napolnjenega injekcijskega peresnika, sicer se varovalo igle lahko zaskoči in ne boste prejeli celotnega odmerka.
English: Live vaccines should not be used concurrently in patients treated with Tremfya.
Slovenian: Bolniki, ki prejemajo zdravilo Tremfya, ne smejo sočasno prejeti živih cepiv.
English: 1 pre-filled pen Component of a multipack, cannot be sold separately
Slovenian: Posamezni deli se ne smejo prodajati ločeno.
English: Histidine
Slovenian: Tremfya.
English: Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
Slovenian: To je vrsta beljakovine, ki jo imenujemo monoklonsko protitelo.
English: No new safety findings were observed in patients who switched from ustekinumab to guselkumab.
Slovenian: Pri bolnikih, ki so prešli z ustekinumaba na guselkumab, niso opazili nobenih novih težav v povezavi z varnostjo zdravila.
English: Injection site erythema Uncommon Injection site pain
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti eritem na mestu injiciranja občasni bolečina na mestu injiciranja
English: It is supplied as a carton pack containing one single-dose pre-filled pen and as a multipack containing 2 (2 packs of 1) single-dose pre-filled pens.
Slovenian: Na voljo je v škatli, ki vsebuje en napolnjen injekcijski peresnik za enkratno odmerjanje in v večjem pakiranju, ki vsebuje 2 napolnjena injekcijska peresnika za enkratno odmerjanje (2 pakiranji po 1 napolnjen injekcijski peresnik.
English: Tremfya 100 mg solution for injection in pre-filled syringe.
Slovenian: Tremfya 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: DLQI score > 1 at baseline, n Subjects with DLQI 0/1
Slovenian: 156. teden indeks DLQI, preiskovanci z izhodiščno oceno > 1, n Preiskovanci z indeksom DLQI
English: Complete injection
Slovenian: Zaključek injiciranja
English: Throw the used pre-filled syringe away
Slovenian: Napolnjen injekcijski peresnik postavite na kožo
English: Inject Tremfya using the pre-filled pen
Slovenian: Injicirajte zdravilo Tremfya z napolnjenim injekcijskim peresnikom
English: p < 0.001 for the comparisons between guselkumab and placebo for the co-primary endpoints.
Slovenian: p < 0,001 za primerjavo med guselkumabom in placebom p < 0,001 za primerjavo med guselkumabom in adalimumabom za glavne sekundarne cilje opazovanja p < 0,001 za primerjavo med guselkumabom in placebom za druge primarne cilje opazovanja primerjave med guselkumabom in adalimumabom niso izvajali p < 0,001 za primerjavo med guselkumabom in adalimumabom
English: Tremfya 100 mg solution for injection in pre-filled syringe
Slovenian: Tremfya 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Do not touch, fan or blow on the injection site after you have cleaned it.
Slovenian: Ko ste mesto injiciranja očistili, se ga ne dotikajte in ne sušite s fenom ali pihanjem.
English: Take the pre-filled pen out of the carton.
Slovenian: Napolnjen injekcijski peresnik vzemite iz škatle.
English: Each pre-filled pen contains 100 mg of guselkumab in 1 mL.
Slovenian: En napolnjen injekcijski peresnik vsebuje 100 mg guselkumaba v 1 ml raztopine.
English: Very common Upper respiratory infections Common
Slovenian: Bolezni prebavil pogosti diareja
English: Medication injects as you push.
Slovenian: Medtem ko potiskate držalo, se zdravilo injicira.
English: Do not use the pre-filled pen if it is dropped after removing the cap.
Slovenian: Če vam napolnjen injekcijski peresnik po odstranitvi pokrovčka pade iz rok, ga ne uporabite.
English: Week After Randomisation
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Week
Slovenian: PASI
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Slovenian: Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic, če je to ustrezno, bodo zagotovili, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
English: The study shall be conducted in more than one Member State and the protocol shall be submitted to the PRAC within 3 months of the commission decision for this procedure.
Slovenian: Študijo je treba izvesti v več kot eni državi članici, protokol pa je treba predložiti odboru PRAC v treh mesecih od izdaje sklepa Komisije v zvezi s tem postopkom;
English: The Marketing Authorisation Holders shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor off-label use.
Slovenian: 3. imetniki dovoljenj za promet z zdravilom morajo izvesti študijo o uporabi zdravil, namenjeno oceni učinkovitosti ukrepov za zmanjšanje tveganja ter spremljanju nenamenske uporabe.
English: A study shall be conducted to generate robust data on the efficacy of domperidone in the relief of symptoms of nausea and vomiting in children at the recommended doses.
Slovenian: 1. izvesti je treba študijo za pridobitev zanesljivih podatkov o učinkovitosti priporočenih odmerkov domperidona pri lajšanju simptomov slabosti in bruhanja pri otrocih.
English: The Marketing Authorisation Holders for the rectal formulations that remain authorised shall conduct a pharmacokinetic study to generate data to allow for a comparison between the rectal and oral formulations.
Slovenian: 2. imetniki dovoljenj za promet s farmacevtskimi oblikami za rektalno uporabo, ki so še naprej odobrene, morajo izvesti farmakokinetično študijo za pridobitev podatkov, ki bodo omogočili primerjavo med farmacevtskimi oblikami za rektalno in peroralno uporabo.
English: The final study report shall be submitted to the National Competent Authorities within 1 year of the commission decision for this procedure.
Slovenian: Končno poročilo o študiji je treba pristojnim nacionalnim organom predložiti v enem letu od izdaje sklepa Komisije v zvezi s tem postopkom;
English: The Marketing Authorisations Holders of products for which a paediatric indication is approved shall submit the protocols of new or ongoing studies to the National Competent Authorities within 4 months of the commission decision for this procedure.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki so odobrena za pediatrično indikacijo, morajo pristojnim nacionalnim organom predložiti protokole novih študij ali študij, ki že potekajo, v štirih mesecih od izdaje sklepa Komisije v zvezi s tem postopkom.
English: The final study report shall be submitted to the National Competent Authorities within 36 months of endorsement of the protocol, and updates on progress with recruitment to the study shall be submitted to the National Competent Authorities on a yearly basis.
Slovenian: Končno poročilo o študiji je treba pristojnim nacionalnim organom predložiti v 36 mesecih od potrditve protokola, enkrat na leto pa je treba predložiti tudi poročilo o napredku pri pridobivanju oseb za sodelovanje v študiji;
English: Within 3 months of the commission decision for this procedure, the MAHs shall submit to the National Competent Authorities a Risk Management Plan containing the key elements described in the PRAC assessment report.
Slovenian: 4. imetniki dovoljenj za promet z zdravilom morajo pristojnim nacionalnim organom v treh mesecih od izdaje sklepa Komisije v zvezi s tem postopkom predložiti načrt obvladovanja tveganj, ki bo vseboval ključne elemente, opisane v poročilu o oceni zdravila odbora PRAC.
English: Ref. EMEA/CHMP/220307/2006
Slovenian: EMEA/CHMP/220307/2006
English: SURFAXIN was designated as an ‘orphan medicine' on 29 July 2004.
Slovenian: Zdravilo SURFAXIN je bilo določeno kot zdravilo sirota dne 29. julija 2004.
English: London, 29 June 2006
Slovenian: London, 29. junija 2006 Ref. dok.
English: The main concern of the CHMP was related to the way the medicine is made, and in particular to the stability of the medicine.
Slovenian: Glavni zadržki CHMP so bili povezani z načinom izdelave zdravila in še posebej z njegovo stabilnostjo.
English: It contains fat ingredients and a synthetic protein (sinapultide).
Slovenian: Vsebuje maščobne sestavine in sintetično beljakovino (sinapultid).
English: It is supplied in a vial containing 8 ml of the medicinal product.
Slovenian: Na voljo je v vialah, ki vsebujejo po 8 ml zdravila.
English: The presence of synthetic ingredient prevents potential risks associated with animal-derived substance such as potential transmission of infectious agents.
Slovenian: Z uporabo sintetične sestavine se izognemo morebitnemu tveganju, povezanemu z uporabo snovi živalskega porekla, kot je na primer morebiten prenos povzročiteljev okužb.
English: Data to support the indication for the treatment of RDS were not sufficient.
Slovenian: Podatki v podporo indikaciji za zdravljenje sindroma dihalne stiske niso bili zadostni.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for SURFAXIN
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo SURFAXIN
English: The effects of SURFAXIN were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila SURFAXIN so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: Therefore, at the time of the withdrawal, the Committee's provisional view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Slovenian: Zato je bil v času umika Odbor začasnega mnenja, da koristni učinki niso bili zadostno dokazani in niso večji od znanih tveganj.
English: It mainly occurs in premature babies, where the onset of difficulty in breathing is within minutes to a few hours after birth.
Slovenian: Največkrat se pojavi pri nedonošenčkih, pri katerih težave dihanja nastopijo že v nekaj minutah do nekaj urah po rojstvu.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with SURFAXIN?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila SURFAXIN?
English: The letter from the Company notifying the EMEA of the withdrawal of SURFAXIN is available here.
Slovenian: Dopis, s katerim je podjetje obvestilo EMEA o umiku zdravila SURFAXIN, je na voljo tukaj.
English: The CHMP was still questioning whether the design and the results of the studies were sufficient to establish that the product will be at least as effective and safe as other surfactant agents currently used to prevent RDS.
Slovenian: CHMP je še vedno v dvomih, ali so načrt in rezultati raziskave zadostni, da bi bilo mogoče na njihovi podlagi ugotoviti, ali bo zdravilo vsaj tako učinkovito in varno kot druga površinsko aktivna sredstva, ki se trenutno uporabljajo za preprečevanje sindroma dihalne stiske.