FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP questioned though the benefit-risk of ciclosporin in “prevention of graft rejection following bone marrow transplantation”: the CHMP requested the MAH to submit data confirming a positive benefit-risk of ciclosporin in terms of frequency of stem cell engrafting/graft failure beyond the benefits/risk (B/R) of conditioning treatment.
Slovenian: Kljub temu je imel CHMP pomisleke glede pozitivnega razmerja med tveganji in koristmi pri indikaciji „preprečevanje zavrnitve presadka po presaditvi kostnega mozga": zahteval je, da imetnik dovoljenja za promet z zdravilom predloži podatke, ki potrjujejo, da je razmerje med tveganji in koristmi ciklosporina v smislu stopnje neuspešnosti vsaditve matičnih celic/odpovedi presadka ugodnejše od razmerja med tveganji in koristmi pripravljalnega zdravila.
English: The MAH acknowledged that food affects the absorption of ciclosporin both from the Sandimmun formulation and, to a lesser extent, from the Sandimmun Neoral formulation.
Slovenian: Imetnik dovoljenja za promet z zdravilom je potrdil, da hrana vpliva na absorpcijo ciklosporina iz zdravila Sandimmun in v manjši meri tudi iz zdravila Sandimmun Neoral.
English: The CHMP endorses this proposal
Slovenian: CHMP je ta predlog odobril.
English: The MAH proposed wordings for the sub-sections Summary of the safety profile, Doses/side effects, Infections and infestations and Neoplasms, Other ADRs from post-marketing experience.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal besedila za podpoglavja Povzetek varnostnega profila, Odmerki/neželeni učinki, Infekcijske in parazitske bolezni, Novotvorbe in Drugi neželeni učinki, o katerih so poročali v obdobju trženja.
English: Based on the most commonly approved wording in EU member states and the recent version of the company core data sheet (CDS) dated 13 February 2012, the MAH proposed a wording which is already approved in 13 EU MS.
Slovenian: Imetnik dovoljenja za promet z zdravilom je upošteval besedilo, ki je odobreno v največ državah članicah EU, in najnovejšo različico krovnega dokumenta farmacevtske družbe (CDS) z dne 13. februarja 2012 ter predlagal besedilo, ki je že odobreno v 13 državah članicah EU.
English: However in view of the CHMP concerns the MAH revised and shortened the initially proposed text, leading for a final wording which was endorsed by the CHMP.
Slovenian: Vendar pa je zaradi zadržkov odbora CHMP imetnik dovoljenja za promet z zdravilom ponovno pregledal in skrajšal predlagano besedilo ter pripravil končno različico, ki jo je CHMP odobril.
English: Furthermore, in addition to a strengthening of the monitoring of renal function, the CHMP was of the view that occasional monitoring of ciclosporin blood levels were also relevant in these indications.
Slovenian: Prav tako je CHMP menil, da bi bilo pri teh indikacijah poleg pogostejšega preverjanja delovanja ledvic potrebno tudi občasno preverjanje koncentracij ciklosporina v krvi.
English: Finally the MAH was also requested to update this section with more information concerning the inhibitory potential of ciclosporin on other transporters than Pgp.
Slovenian: Imetnik dovoljenja za promet z zdravilom je moral poleg tega to poglavje posodobiti z dodatnimi informacijami o možnem zaviralnem učinku ciklosporina na druge prenašalce poleg P-glikoproteina.
English: After review of the dataset, the proposed posology in the bone marrow transplantation indication as approved in 16 EU MS was acceptable to the CHMP.
Slovenian: Po pregledu nabora podatkov je CHMP menil, da je predlagano odmerjanje pri indikaciji presaditev kostnega mozga, ki je odobreno v 16 državah članicah, sprejemljivo.
English: In addition, the CHMP requested the MAH to specify in the SmPC whether Sandimmun/Sandimmun Neoral should be administered with or without food or if administration may be performed irrespective of concomitant food intake.
Slovenian: Poleg tega je CHMP od imetnika dovoljenja za promet z zdravilom zahteval, da v povzetku glavnih značilnosti zdravila navede, ali je treba zdravilo Sandimmun/Sandimmun Neoral jemati s hrano ali brez nje oziroma ali se lahko zdravilo jemlje neodvisno od obrokov hrane.
English: Section 5.1 - Pharmacodynamic Properties
Slovenian: Poglavje 5.1 - Farmakodinamične lastnosti
English: The CHMP is of the view that introducing Sandimmun Neoral for the treatment of rejection is most appropriate for cellular rather than humoral rejection, based on the mechanism of action of CNI's.
Slovenian: CHMP je menil, da je glede na mehanizem delovanja zaviralcev kalcinevrina uporaba zdravila Sandimmun Neoral za zdravljenje zavrnitve primernejša pri celični kot pri humoralni zavrnitvi.
English: The MAH proposed the wording related to the method of oral administration which is approved in 12 EU countries.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal besedilo v zvezi z načinom peroralne uporabe, ki je odobreno v 12 državah EU.
English: Lastly the MAH recommended oral administration in non-transplantation indications due to lack of data and potential risk for anaphylactic reactions with intravenous use; this was acknowledged by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pri indikacijah, ki niso povezane s presaditvijo, zaradi pomanjkljivih podatkov in možnega tveganja za anafilaktične reakcije pri intravenski uporabi, predlagal peroralno uporabo zdravila; CHMP je predlog odobril.
English: The MAH proposed a wording for recommendations related to the switch between Sandimmun and Sandimmun Neoral in accordance with the approved wording of 9 countries.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal besedilo za priporočila v zvezi s prehodom z zdravila Sandimmun na zdravilo Sandimmun Neoral, ki je skladno z besedilom, odobrenim v 9 državah.
English: Therefore, based on clinical data summary on atopic dermatitis and references provided by the MAH, the CHMP considers the argumentation made by the MAH acceptable and therefore agrees with the above mentioned wording.
Slovenian: Zato je CHMP na podlagi povzetka kliničnih podatkov o atopijskem dermatitisu in referenčne literature, ki jih je predložil imetnik dovoljenja za promet z zdravilom, zaključil, da je utemeljitev imetnika dovoljenja za promet zadovoljiva in se je strinjal z zgoraj navedenim besedilom.
English: The MAH provided the requested data and clarifications accordingly.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil ustrezne podatke in pojasnila.
English: The MAH's proposed indication wording for nephritic syndrome is approved in 16 EU countries.
Slovenian: Besedilo za indikacijo nefrotski sindrom, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je odobreno v 16 državah EU.
English: Additional pharmacokinetics and pharmacodynamics studies, as well as non clinical trials were performed with Sandimmun Neoral medicinal product to support its registration.
Slovenian: V podporo vlogi za registracijo so bile izvedene še dodatne farmakokinetične in farmakodinamične študije ter predklinična preskušanja z zdravilom Sandimmun Neoral.
English: The MAH addressed the points raised by the CHMP and proposed a final wording for this section on which the CHMP agreed.
Slovenian: Imetnik dovoljenja za promet z zdravilom je upošteval pripombe odbora CHMP in predlagal končno besedilo za to poglavje, ki ga je CHMP odobril.
English: In view of the above dataset, the CHMP considered that the efficacy of Sandimmun (oil based formulation of ciclosporin) has been demonstrated in 4 randomized controlled and 5 uncontrolled studies as well as studies conducted in pediatric patients.
Slovenian: Učinkovitost zdravila Sandimmun (pripravka ciklosporina na oljni osnovi) so dokazali v 4 randomiziranih nadzorovanih in 5 nenadzorovanih študijah.
English: The MAH proposed the following wording for the posology: “The dose ranges given for oral administration are intended to serve as guidelines only.
Slovenian: Imetnik dovoljenja za promet z zdravilom je za podpoglavje o odmerjanju predlagal naslednje besedilo: „Razpone odmerkov za peroralno uporabo je treba upoštevati zgolj kot smernice.
English: The CHMP did not agree with the wording proposed by the MAH in this section.
Slovenian: CHMP se ni strinjal z besedilom, ki ga je za to poglavje predlagal imetnik dovoljenja za promet.
English: In addition, a clarification of the B/R of ciclosporin in prevention of graft rejection after nonmyloablative stem cell transplantation was also requested by the CHMP; the CHMP reviewed the MAH's position and considered unnecessary to specify myeloablative vs. non-myeloablative stem cell transplantation in the Ciclosporin indication.
Slovenian: CHMP je zahteval tudi razjasnitev razmerja med tveganji in koristmi ciklosporina pri preprečevanju zavrnitve presadka po nemieloablativni presaditvi matičnih celic; CHMP je preučil mnenje imetnika dovoljenja za promet z zdravilom in menil, da razlikovanje med mieloablativno in nemieloablativno presaditvijo matičnih celic pri indikaciji za ciklosporin ni potrebno.
English: Based on the comprehensive clinical data summary on psoriasis and references provided by the MAH, the CHMP considers the argumentation made by the MAH acceptable and therefore agrees with the wording proposed by the MAH.
Slovenian: Na podlagi izčrpnega povzetka kliničnih podatkov o psoriazi in referenčne literature, ki jih je predložil imetnik dovoljenja za promet z zdravilom, je CHMP zaključil, da je utemeljitev imetnika dovoljenja za promet zadovoljiva, zato se je strinjal s predlaganim besedilom.
English: Regarding the sub-sections Doses/side effects, Infections and infestations and Neoplasms, Other ADRs from post-marketing experience, the MAH proposed align the harmonized SmPC text with the agreed CSP.
Slovenian: Pri podpoglavjih Odmerki/neželeni učinki, Infekcijske in parazitske bolezni, Novotvorbe in Drugi neželeni učinki, o katerih so poročali v obdobju trženja je imetnik dovoljenja za promet z zdravilom predlagal uskladitev besedila povzetka glavnih značilnosti zdravila z odobrenim CSP. CHMP se je strinjal s tem pristopom in predlaganim besedilom.
English: The MAH's proposed indication wording for the uveitis and Behçet uveitis is approved in 14 EU countries.
Slovenian: Besedilo za indikacijo uveitis in Behçetova bolezen, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je odobreno v 14 državah EU.
English: The CHMP agreed with the addition proposed by the MAH.
Slovenian: CHMP se je s predlagano dopolnitvijo strinjal.
English: Two types of studies, open and controlled masked, were carried out in order to evaluate the efficacy of ciclosporin in the treatment of severe sight-threatening intermediate and posterior uveitis.
Slovenian: Za oceno učinkovitosti ciklosporina pri zdravljenju hudega intermediarnega in posteriornega uveitisa, ki ogrožata vid, so izvedli dve vrsti študij - odprto in nadzorovano slepo študijo.
English: The MAH dedicated the whole sub-section to a comparison between Sandimmun and Sandimmun Neoral.
Slovenian: Imetnik dovoljenja za promet z zdravilom je celotno podpoglavje namenil primerjavi med zdraviloma Sandimmun in Sandimmun Neoral.
English: In addition, the CHMP requested the MAH to provide a clear rationale for having slightly different description of pharmacodynamic section in Sandimmun (both oral and injection) vs Sandimmun Neoral versions of SmPCs.
Slovenian: CHMP je zahteval tudi, da imetnik dovoljenja za promet z zdravilom jasno utemelji, zakaj je opis v poglavju o farmakodinamičnih lastnostih v povzetku glavnih značilnosti zdravila za zdravilo Sandimmun (tako za peroralno uporabo kot injiciranje) nekoliko drugačen kot v povzetku glavnih značilnosti zdravila za zdravilo Sandimmun Neoral.
English: The CHMP was of the opinion that a general message about the value of monitoring to guide posology was missing.
Slovenian: CHMP je menil, da manjka splošno opozorilo o pomembnosti spremljanja bolnika pri določanju odmerka.
English: In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun Neoral and associated names.
Slovenian: Po preučitvi predlogov imetnika dovoljenja za promet, njegovih odgovorov na seznam vprašanj in seznam odprtih vprašanj ter razpravi znotraj odbora je CHMP odobril in sprejel usklajene dokumente z informacijami o zdravilu za različne oblike zdravila Sandimmun Neoral in povezanih imen.
English: Transplantation indications:
Slovenian: Indikaciji, povezani s presaditvijo:
English: Thus, the harmonized label for the safety section of the SmPC proposed by the MAH was based on the agreed CSP and enhanced with some newly added information from the full review of the MAH's labels (CDSs).
Slovenian: Usklajeno besedilo za poglavje o varnosti v povzetku glavnih značilnosti zdravila, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je torej temeljilo na odobrenem CSP, ki so mu dodali nekatere nove informacije iz natančnega pregleda dokumentov imetnika dovoljenja za promet z zdravilom (krovnih dokumentov).
English: The MAH agreed to correct this and proposed a wording for Sandimmum and Sandimmum Neoral which was acceptable to the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je odpravil neskladja in predlagal besedilo za zdravili Sandimmun in Sandimmun Neoral, ki ga je CHMP odobril.
English: To achieve a harmonized SmPC, the MAH used the wording that is common to national SmPCs in the majority of MSs and the MAH's Core Data Sheet (CDS) for Sandimmun Neoral (dated 13 February 2012), as well as submitted legacy studies and literature references.
Slovenian: Imetnik dovoljenja za promet z zdravilom je za uskladitev povzetka glavnih značilnosti zdravila uporabil besedilo, ki se uporablja v večini držav članic in v krovnem dokumentu (Core Data SheetCDS) za zdravilo Sandimmun Neoral (z dne 13. februarja 2012), ter predložil starejše študije in referenčno literaturo.
English: Similarly to the section 4.2, wordings for each of the sub-sections for the different non-transplantation indications were discussed and agreed between the CHMP and MAH.
Slovenian: Podobno kot pri poglavju 4.2 sta se odbor CHMP in imetnik dovoljenja za promet z zdravilom dogovorila tudi o besedilih za vsakega od podpoglavij za različne indikacije, ki niso povezane s presaditvijo.
English: The efficacy of Sandimmun (oil based formulation of ciclosporin) has been demonstrated in 4 randomized controlled and 5 uncontrolled studies.The clinical results from these 9 clinical studies were analyzed using a pooling of data from all studies (controlled and uncontrolled).
Slovenian: Klinične rezultate iz teh 9 kliničnih študij so analizirali po združitvi podatkov iz vseh študij (nadzorovanih in nenadzorovanih).
English: The MAH's proposed indication wording for rheumatoid arthritis is approved in 13 EU countries.
Slovenian: Besedilo za indikacijo revmatoidni artritis, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je odobreno v 13 državah EU.
English: The MAH proposed a wording accordingly to include these recommendations, as requested by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal ustrezno besedilo, v katero je vključil priporočila, ki jih je zahteval odbor CHMP.
English: Based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon a harmonised wording of the section 4.2 accordingly for the non-transplantations indications.
Slovenian: Po preučitvi predloga imetnika dovoljenja za promet, njegovih odgovorov na seznam vprašanj (LoQ) in seznam odprtih vprašanj (LoOI) ter razpravi znotraj odbora je CHMP odobril ustrezno usklajeno besedilo poglavja 4.2 za indikacije, ki niso povezane s presaditvijo.
English: • Solid organ transplantation
Slovenian: • Presaditev parenhimskih organov
English: Concerning the sub-sections on infections, renal toxicity and hepatotoxicity, monitoring ciclosporin levels in transplant patients, hypertension, blood lipids increased, live-attenuated vaccines and interactions, wordings were proposed by the MAH and intensively discussed and revisited as per CHMP requests.
Slovenian: Prav tako je imetnik dovoljenja za promet z zdravilom v skladu z zahtevami odbora CHMP predlagal, podrobno obravnaval in ponovno preučil besedila za podpoglavja o infekcijah, toksičnosti za ledvice in jetra, spremljanju koncentracij ciklosporina pri bolnikih po presaditvi, hipertenziji, zvišanih vrednostih lipidov v krvi, živih oslabljenih cepivih in medsebojnem delovanju z drugimi zdravili.
English: The CHMP was in agreement with the MAH's proposal.
Slovenian: CHMP se je s predlogom strinjal.
English: The MAH agreed with the CHMP's opinion and hence revised the wording of the posology in the solid organ transplantation indication accordingly.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal z mnenjem odbora CHMP in ustrezno spremenil besedilo o odmerjanju pri indikaciji presaditev parenhimskih organov.
English: In that context, a thorough comparison of the Feb 2011 agreed CSP information and the safety sections of the newly released CDSs was performed by the MAH.
Slovenian: Na osnovi tega je imetnik dovoljenja za promet z zdravilom natančno primerjal informacije v CSP, ki je bil odobren februarja 2011, in poglavja o varnosti v najnovejših krovnih dokumentih.
English: The MAH agreed with the CHMP's opinion and a wording was agreed accordingly.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal z mnenjem odbora CHMP, zato je bilo besedilo ustrezno usklajeno.
English: With regards to the paragraphs concerning Medical supervision, Lymphomas and other malignancies, Geriatrics, Hyperkalaemia, Hypomagnesemia and Hyperuricaemia, Special excipients, the MAH proposed the CSP wording as the harmonised SmPC text.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal, da se za uskladitev besedila odstavkov v poglavjih povzetka glavnih značilnosti zdravila Zdravniški nadzor, Limfomi in druge maligne spremembe, Geriatrija, Hiperkaliemija, Hipomagneziemija in Hiperurikemija ter Posebne pomožne snovi, uporabi besedilo iz CSP. CHMP se je s predlaganim besedilom strinjal.
English: Based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon a harmonised wording of the section 4.2 accordingly for the special populations.
Slovenian: Po preučitvi predloga imetnika dovoljenja za promet, njegovih odgovorov na seznam vprašanj in seznam odprtih vprašanj ter razpravi znotraj odbora je CHMP odobril ustrezno usklajeno besedilo poglavja 4.2 za posebne skupine bolnikov.
English: Transplantation indications
Slovenian: Indikaciji, povezani s presaditvijo
English: Hence, this supports the lower doses proposed for Sandimmun Neoral in the proposed SmPC.
Slovenian: To kaže na to, da so manjši odmerki, ki so bili v predlaganem povzetku glavnih značilnosti zdravila predlagani za zdravilo Sandimmun Neoral, upravičeni.
English: A revised wording was proposed by the MAH accordingly and endorsed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je nato predlagal spremenjeno besedilo, ki ga je CHMP odobril.
English: The CHMP was of the view that the proposed text is relevant to include and therefore the CHMP agreed with the wordings as proposed by the MAH.
Slovenian: Ta dva odstavka nista bila vključena v CSP. CHMP je menil, da je vključitev predlaganega besedila smiselna, zato je odobril besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom.
English: A wording was agreed accordingly.
Slovenian: Besedilo je bilo ustrezno usklajeno.
English: All MS except Norway have the indication bone marrow transplantation and GVHD approved.
Slovenian: Indikacija presaditev kostnega mozga in GVHD je odobrena v vseh državah članicah, razen na Norveškem.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Sandimmum and associated names (see Annex I).
Slovenian: je odbor CHMP priporočil spremembo dovoljenj za promet z zdravilom Sandimmun in povezanimi imeni (glejte Prilogo I), za katerega so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo opredeljeni v Prilogi III.
English: The proposed wording was acceptable to the CHMP.
Slovenian: CHMP je menil, da je predlagano besedilo sprejemljivo.
English: ” This wording was endorsed by the CHMP.
Slovenian: CHMP je to besedilo odobril.
English: The MAH agrees with the CHMP's view.
Slovenian: CHMP se je strinjal s tem mnenjem.
English: Section 6.3 - Shelf life
Slovenian: Poglavje 6.3 - Rok uporabnosti
English: The MAH accepted the proposal to amend the ADRs as highlighted by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal s spremembo podatkov o neželenih učinkih, ki jo je predlagal CHMP.
English: The MAH proposed to harmonise the SmPC text along with the agreed CSP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal, da se besedilo povzetka glavnih značilnosti zdravila uskladi v skladu z odobrenim CSP. CHMP se je s predlaganim besedilom strinjal.
English: The CHMP therefore agreed with the approach taken by the MAH.
Slovenian: CHMP se je zato strinjal s pristopom imetnika dovoljenja za promet z zdravilom.
English: The daily doses of Neoral should always be given in two divided doses.” The MAH's statement “The dose ranges given for oral administration are intended to serve as guidelines only” is endorsed by the CHMP.
Slovenian: CHMP je odobril stavek imetnika dovoljenja „razpone odmerkov za peroralno uporabo je treba upoštevati zgolj kot smernice“.
English: The CHMP was in agreement with the approach taken by the MAH.
Slovenian: CHMP se je strinjal s pristopom imetnika dovoljenja za promet z zdravilom.
English: This point was addressed by the MAH and a wording was agreed.
Slovenian: Imetnik dovoljenja za promet je obravnaval ta predlog, nato pa je bilo besedilo usklajeno.
English: Thus, a wording was proposed by the MAH and agreed by the CHMP to address this matter.
Slovenian: Imetnik dovoljenja za promet z zdravilom je zato v zvezi s tem predlagal ustrezno besedilo, ki ga je CHMP odobril.
English: • Bone marrow transplantation
Slovenian: • Presaditev kostnega mozga
English: The recommended dose is…
Slovenian: Priporočeni odmerek je …
English: It is unlikely to be serious.
Slovenian: Ni verjetno, da bo šlo za resno težavo.
English: It needs to be treated at once.
Slovenian: To je treba zdraviti takoj.
English: End of 7 days period at room temperature: __/__/____
Slovenian: Konec sedemdnevnega obdobja na sobni temperaturi: __/__/____
English: This can help to provide more information on the safety of medicines like this one.
Slovenian: To pomaga zagotoviti več informacij o varnosti zdravila, kot je to.
English: Find a comfortable, well-lit place.
Slovenian: Pojdite na udobno in dobro osvetljeno mesto.
English: - Allergic reactions:
Slovenian: - Alergijske reakcije:
English: cannot be estimated from the available data.
Slovenian: ni mogoče oceniti iz razpoložljivih podatkov.
English: Please use as follows:
Slovenian: Uporabljajte na naslednji način:
English: Proper treatment of your disease, however, requires close and constant co-operation with your doctor.
Slovenian: Kljub temu pa ustrezno zdravljenje vaše bolezni zahteva pozorno in stalno sodelovanje z zdravnikom.
English: This medicine may not be suitable for the following patients.
Slovenian: To zdravilo morda ne bo primerno za naslednje bolnike.
English: Furthermore, deaths were more frequent in this patient group compared to younger patients.
Slovenian: Poleg tega so bile smrti v tej skupini pogostejše kot pri mlajših bolnikih.
English: It acts as a mitosis-stimulating factor and differentiation hormone.
Slovenian: Deluje kot mitozo stimulirajoči dejavnik in diferenciacijski hormon.