natgillin/translations-raw huggingface dataset:
Finally the MAH was also requested to update this section with more information concerning the inhibitory potential of ciclosporin on other transporters than Pgp.
U konačnici od nositelja odobrenja zatraženo je da ažurira ovaj dio s više informacija u vezi inhibitorskog potencijala ciklosporina na druge transportere, uz P-glikoprotein.
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.
Nadalje, CHMP je zatražio od nositelja odobrenja da u sažetku opisa svojstava lijeka specificira treba li se lijek Sandimmun/Sandimmun Neoral uzimati s hranom ili bez hrane ili može li se lijek uzimati bez obzira na istovremeni unos hrane.
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.
Nositelj odobrenja priznao je da hrana utječe na apsorpciju ciklosporina iz formulacije lijeka Sandimmun te, u manjoj mjeri, iz formulacije lijeka Sandimmun Neoral.
The CHMP was in agreement with this approach and a revised wording was agreed consequently.
CHMP bio je suglasan s ovim pristupom, te je naknadno usuglašena revidirana formulacija.
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.
Nadalje, CHMP zatražio je od nositelja odobrenja da dostavi jasnu logičku podlogu za neznatne razlike u opisu farmakodinamičkog dijela u sažetku opisa svojstava lijeka za lijek Sandimmun (oralna primjena i injekcija) u odnosu na verziju za lijek Sandimmun Neoral.
Sandimmun is available as Sandimmun soft gelatin capsules (25 mg, 50 mg and 100 mg), Sandimmun oral solution, 100 mg/ml and Sandimmum concentrate for solution for infusion, 50mg/ml.
Lijek Sandimmun dostupan je kao Sandimmun mekane želatinaste kapsule (25 mg, 50 mg i 100 mg), Sandimmun oralna otopina, 100 mg/ml, te Sandimmum koncentrat za otopinu za infuziju, 50 mg/ml.
The MAH proposed to harmonise the SmPC text along with the agreed CSP.
Nositelj odobrenja predložio je usklađivanje teksta sažetka opisa svojstava lijeka zajedno s dogovorenim CSP.
Switching from Sandimmun to Sandimmun Neoral
Prebacivanje bolesnika s lijeka Sandimmun na lijek Sandimmun Neoral
The MAH proposed wording was in line with the overall strategy undertaken to propose a harmonized wording based on the most commonly approved label across the EU community.
Formulacija koju je predložio nositelj odobrenja bila je u skladu sa cjelokupnom strategijom poduzetom za predlaganje usklađene formulacije na temelju najčešće odobrenih naljepnica diljem Europske Zajednice.
Sandimmun Neoral is available as Sandimmun Neoral soft gelatin capsules (10 mg, 25 mg, 50 mg and 100 mg) and Sandimmun Neoral oral solution, 100 mg/ml.
Lijek Sandimmun Neoral dostupan je kao Sandimmun Neoral mekane želatinaste kapsule (10 mg, 25 mg, 50 mg i 100 mg), te Sandimmun Neoral oralna otopina, 100 mg/ml.
The CHMP did not agree with the wording proposed by the MAH in this section.
CHMP nije suglasan s formulacijom koju je predložio nositelj odobrenja u ovom dijelu.
Hence, this supports the lower doses proposed for Sandimmun Neoral in the proposed SmPC.
Stoga, ovo potvrđuje manje doze predložene za lijek Sandimmun Neoral u predloženom sažetku opisa svojstava lijeka.
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).
Stoga, usklađene naljepnice za sigurnosne dijelove sažetka opisa svojstava lijeka, koje je predložio nositelj odobrenja, temelje se na usuglašenom CSP-u i dopunjene su određenim posljednjim dodanim informacijama iz cjelokupnog pregleda naljepnica nositelja odobrenja (CDS).
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.
Na temelju sažetka opsežnih kliničkih podataka za psorijazu i referenci dostavljanih od strane nositelja odobrenja, CHMP smatra argumentaciju iznijetu od strane nositelja odobrenja prihvatljivom te se stoga slaže s formulacijom, koju je predložio nositelj odobrenja.
The MAH proposed the following wording for this indication: “Sandimmun Neoral is indicated in patients with severe atopic dermatitis when systemic therapy is required.” The MAH's proposed indication wording for the Atopic dermatis is approved in 15 EU countries.
Nositelj odobrenja predložio je sljedeću formulaciju za ovu indikaciju: „Sandimmun Neoral indiciran je u bolesnika s teškim atopičkim dermatitisom kada je potrebna sistemna terapija.“
The MAH agreed to correct this and proposed a wording for Sandimmum and Sandimmum Neoral which was acceptable to the CHMP.
Nositelj odobrenja suglasan je s ispravkom istog, te je predložio formulaciju za lijekove Sandimmum i Sandimmum Neoral, koja je bila prihvatljiva CHMP-u.
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.
U vezi s paragrafima koji se tiču Liječničkog nadzora, Limfoma i drugih malignosti, Gerijatrije, Hiperkalemije, Hipomagnezemije i Hiperurikemije, Posebnih pomoćnih tvari, nositelj odobrenja predložio je formulaciju CSP-a koja je usklađena s tekstom sažetka opisa svojstava lijeka.
The MAH addressed this concern; based on the submitted data the CHMP agreed with the MAH that the common practice is to change to another agent in case of rejection.
Na temelju dostavljenih podataka, CHMP složio se s nositeljem odobrenja da je uobičajena praksa promijeniti lijek u slučaju odbacivanja.
To ensure that the Core Safety Information of the updated CDSs remains in line with the agreed CSP information, newly incorporated safety information into the CDS was proposed by the MAH for consideration into the agreed CSP, hence for the harmonized Eu SmPC safety related sections.
Core Safety Information) ažuriranih CDS-ova u skladu s usuglašenim informacijama CSP-a, nositelj odobrenja predložio je da se sigurnosne informacije, koje su posljednje uvrštene u CDS, razmotre za uvrštavanje u usuglašeni CSP, te slijedom toga i za usklađene dijelove sažetka opisa svojstava lijeka za EU povezanih sa sigurnošću.
Transplantation indications:
Transplantacijske indikacije:
In parallel of these 9 performed studies, 2 double-blind placebo controlled multicenter studies and 1 multicenter study comparing ciclosporin with cyclophosphamide in steroidresistant patients had to be stopped prematurely because of a lack of suitable patients consenting to receive placebo or a cytostatic agent.
provedenih ispitivanja, zbog manjka odgovarajućih bolesnika suglasnih s primanjem placeba ili citostatičnog lijeka morala su prijevremeno biti prekinuta 2 dvostruka slijepa placebo kontrolirana multicentrična ispitivanja i 1 multicentrično ispitivanje, u kojima je uspoređen ciklosporin sa ciklofosfamidima u bolesnika otpornih na steroide.
In the European Union (EU), Sandimmum and Sandimmun Neoral are registered via national procedures.
Lijekovi Sandimmum i Sandimmun Neoral registrirani su u Europskoj uniji putem nacionalnih postupaka.
The MAH addressed the points raised by the CHMP and proposed a final wording for this section on which the CHMP agreed.
Nositelj odobrenja riješio je ova pitanja koja je postavio CHMP, te je predložio konačnu formulaciju za ovaj dio, s kojom je CHMP suglasan.
The MAH's proposed indication wording for the uveitis and Behçet uveitis is approved in 14 EU countries.
Nositelj odobrenja predložio je formulaciju indikacije za uveitis i Behçetov uveitis koja je odobrena u 14 država EU.
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.
Nadalje, CHMP zatražio je pojašnjenje omjera koristi i rizika za ciklosporin u prevenciji odbacivanja presatka nakon nemiloablacijske transplantacije matičnih stanica; CHMP pregledao je stav nositelja odobrenja te smatra nepotrebnim da se specificira mijeloablacijska transplantacija u odnosu na nemijeloablacijsku transplantaciju matičnih stanica u indikaciji za ciklosporin.
This section contains general parts as well as separate sub-sections for each indication.
Dio 4.2 - Doziranje i način primjene Ovaj dio sadrži opće dijelove kao i zasebne poddijelove za svaku indikaciju.
The MAH dedicated the whole sub-section to a comparison between Sandimmun and Sandimmun Neoral.
Nositelj odobrenja posvetio je cijeli poddio usporedbi između lijeka Sandimmun i Sandimmun
The MAH's proposed indication wording for nephritic syndrome is approved in 16 EU countries.
Formulacija indikacije za nefrotski sindrom predložena od strane nositelja odobrenja odobrena je u 16 država EU.
Based on the above the CHMP considers the benefit/risk ratio of Sandimmun Neoral to be favourable and the harmonised PI to be approvable.
Na temelju prethodno navedenog, CHMP smatra da je omjer koristi i rizika lijeka Sandimmun Neoral povoljan, te da se usklađene informacije o lijeku mogu odobriti.
• Solid organ transplantation:
• Transplantacija organa:
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.
S obzirom na poddijelove Doze/nuspojave, Infekcije i infestacije i Neoplazme, Druge nuspojave na temelju iskustva primjene lijeka nakon stavljanja u promet, nositelj odobrenja predložio je usklađivanje usklađenog teksta sažetka opisa svojstava lijeka s usuglašenim CSP-om.
Section 6.4 - Special precautions for storage
Dio 6.4 - Posebne mjere pri čuvanju lijeka
A number of areas of disharmony in the Product Information have been considered as follows:
Smatra se da je u informacijama o lijeku neusuglašen sljedeći niz područja:
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.
Nakon pregleda skupa podataka, CHMP prihvatio je predloženo doziranje za indikaciju transplantacije koštane srži odobreno u 16 država članica EU.
The CHMP considered that the use of Hypericum perforatum (St. John's wort, SJW) products in the treatment of a mild depression was not considered to balance the potential risk of an acute organ rejection caused by SJW induction; the CHMP requested the introduction of a contraindication accordingly.
CHMP smatra da primjena lijekova koji sadrže hypericum perforatum (Gospinu travu) u liječenju blage depresije nije uzeta u obzir za poništavanje mogućeg rizika akutnog odbacivanja organa uzrokovanog indukcijom Gospine trave.
The MAH proposed a wording accordingly to include these recommendations, as requested by the CHMP.
Prema tome, nositelj odobrenja predložio je formulaciju kako bi se uključile ove preporuke zatražene od strane CHMP-a.
Whereas
pozitivan.
The wording proposed by the MAH is already approved in 24 countries and several other countries have very similar information.
Prebacivanje bolesnika između oralnih formulacija ciklosporina Formulacija, koju je predložio nositelj odobrenja, već je odobrena u 24 države, a nekoliko drugih država imaju slične informacije.
It is recommended that Sandimmun Neoral be administered on a consistent schedule with regard to time of day and relation to meals.
Neoral uzima prema konzistentnom rasporedu s obzirom na doba dana i obroke.“
• Solid organ transplantation
• Transplantacija organa
The MAH is of the view that the efficacy of ciclosporin in bone marrow transplantation and GVHD is well established from the data in the original MAA, published clinical studies and extensive clinical use.
GVHD-a dobro utvrđena na temelju podataka iz izvornog zahtjeva za odobrenje za stavljanje lijeka u promet, objavljenih kliničkih ispitivanja i opsežne kliničke uporabe.
General monitoring of posology.
Opće praćenje doziranja.
Non-transplantation indications:
Netransplantacijske indikacije:
In the original Sandimmun studies, initial doses in the range 14-18 mg/kg/day have been used and these were subsequently reduced to a maintenance dose in the range 6-10 mg/kg/day.
mg/kg/dana, te su iste naknadno smanjene na dozu održavanja u rasponu od 6-10 mg/kg/dan.
The MAH proposed a new general wording to introduce the paragraph on non- transplantation indications, as general recommendations.
Kao općenite preporuke, nositelj odobrenja predložio je novu općenitu formulaciju kao uvod u paragraf o netransplantacijskim indikacijama.
The CHMP was in agreement with this approach and related wordings as proposed by the MAH.
CHMP suglasan je s ovim pristupom i povezanom formulacijom u skladu s prijedlogom nositelja odobrenja.
• Bone marrow transplantation
• Transplantacija koštane srži
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.
List of Outstanding Issues) i nakon razmatranja Povjerenstva, CHMP je suglasan s i prihvatio je usklađene komplete dokumenata informacija o lijeku za različite oblike lijeka Sandimmun Neoral i povezane nazive.
The MAH addressed the CHMP's concerns; the CHMP is of the view that clinical experience supports the proposed additions in the indication.
Mišljenje je CHMP-a da kliničko iskustvo podupire predložene dopune u indikaciji.
However the statement “The daily doses of Neoral should always be given in two divided doses” was partly endorsed by the CHMP since the word “always” should be omitted (in some cases, three times daily administration may be needed).
„uvijek“ treba biti izostavljena (u određenim je slučajevima potrebno uzimati lijek tri puta na dan).
The MAH's proposed indication wording for rheumatoid arthritis is approved in 13 EU countries.
Formulacija indikacije za reumatoidni artritis predložena od strane nositelja odobrenja odobrena je u 13 država EU.
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.
List of Outstanding Issues) te po završetku rasprave Povjerenstva, CHMP usuglasio je prema tome usklađenu formulaciju djela 4.2 za posebne populacije.
The proposed wording was reviewed and agreed accordingly.
Predložena formulacija je pregledana i prema tome usuglašena.
The CHMP also requested the MAH to provide more detailed information that could help the dose adjustments.
CHMP također je zatražio od nositelja odobrenja da dostavi detaljnije informacije,
The CHMP agreed with the addition proposed by the MAH.
CHMP složio se s dodatkom kojeg je predložio nositelj odobrenja.
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).
Klinički rezultati ovih 9 kliničkih ispitivanja analizirani su ispitivanjem podataka iz svih ispitivanja (kontroliranih i nekontroliranih).
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.
Slično kao u slučaju djela 4.2, CHMP i nositelj odobrenja raspravili su i usuglasili formulacije za svaki poddio za različite netransplantacijske indikacije.
The MAH accepted the proposal to amend the ADRs as highlighted by the CHMP.
Nositelj odobrenja prihvatio je prijedlog da dopuni nuspojave kako je istaknuo CHMP.
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.
Sandimmun i lijeka Sandimmun Neoral u skladu s odobrenom formulacijom u 9 država.
Considering the narrow therapeutic window for ciclosporin, the CHMP requested the MAH to consider ciclosporin intake in order to reduce intra-individual variability.
zatražio je od nositelja odobrenja da razmotri unos ciklosporina kako bi se smanjila intraindividualna varijabilnost.
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.
Na temelju mehanizma djelovanja CNI-a, mišljenje je CHMP-a da je uvođenje lijeka Sandimmun Neoral u liječenje odbacivanja najprimjerenije za stanično, a ne za humoralno odbacivanje.
The MAH agreed with the CHMP's opinion and a wording was agreed accordingly.
Nositelj odobrenja suglasan je s mišljenjem CHMP-a, te je prema tome usuglašena formulacija.
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.
List of Outstanding Issues) te po završetku rasprave Povjerenstva, CHMP usuglasio je prema tome usklađenu formulaciju djela 4.2 za netransplantacije.
As recorded in the minutes of the prereferral meeting held on 27 July 2011, regarding the approach to label harmonisation, the Agency agreed with the MAH's proposal to use the SmPC wording that is common in the majority of the Members States, the Sandimmun and Sandimmun Neoral CDSs as justified by the review of legacy studies and literature references.
Agencija se složila s prijedlogom nositelja da se upotrijebi formulacija sažetka opisa svojstava lijeka koja je uobičajena u većini država članica, CDS-ovi lijekova Sandimmun i Sandimmun Neoral kako je opravdano pregledom naslijeđenih ispitivanja i bibliografskim referencama.
• 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).
• sažetak opisa svojstava lijeka, naljepnica i uputa o lijeku, koje su predložili nositelji odobrenja, ocijenjeni su na temelju dostavljene dokumentacije i znanstvenog razmatranja unutar Povjerenstva
Thus, a wording was proposed by the MAH and agreed by the CHMP to address this matter.
No, nositelj odobrenja predložio je formulaciju, a CHMP je suglasan da se oslovi ovo pitanje.
Section 4.8 - Undesirable Effects
Dio 4.8 - Nuspojave
The MAH agrees with the CHMP's view.
Nositelj odobrenja suglasan je s mišljenjem CHMP
Section 6.3 - Shelf life
Dio 6.3 - Rok valjanosti
The CHMP agreed with the wording proposed by the MAH.
CHMP složio se s formulacijom koju je predložio nositelj odobrenja.
A revised wording was proposed by the MAH accordingly and endorsed by the CHMP.
Prema tome, nositelj odobrenja predložio je revidiranu formulaciju, koju je CHMP potvrdio.
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.
Stoga, na temelju sažetka kliničkih podataka o atopičkom dermatitisu i referencama navedenima od strane nositelja odobrenja,
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.
Mišljenje je CHMP-a da je važno uključiti predloženi tekst, te je stoga CHMP
The approach taken by the MAH to achieve a proposed harmonized SmPC with regard to the safety sections of the SmPC (sections 4.3 to 4.9) was to use as a basis the most recently updated MAH's Core Data Sheet (CDS) of Sandimmun Neoral, dated 13 February 2012 (as justified by a review of submitted legacy studies, and identified literature references) and the finalized Core Safety profile (CSP) from the last PSUR 13 work sharing (WS) procedure (EE/H/PSUR/0007/001).
Sheet) nositelja odobrenja za lijek Sandimmun Neoral, od dana 13. veljače 2012. godine (kako je opravdano pregledom dostavljenih naslijeđenih ispitivanja i identificiranim bibliografskim referencama) te završnog Sigurnosnog profila lijeka (CSP, Core Safety Profile) iz posljednjeg 13.
However, in case of a more prolonged inability to use oral ciclosporin, use of IV ciclosporin should be considered, provided that care is taken to administer an adequate IV dose.
potrebno je razmotriti intravenoznu primjenu ciklosporina, ukoliko su poduzete mjere za primjenu primjerene intravenozne doze.
” This wording was endorsed by the CHMP.
CHMP odobrio je ovu formulaciju.
The CHMP therefore agreed with the approach taken by the MAH.
Stoga je CHMP suglasan s pristupom nositelja odobrenja.
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Razlozi za dopunu sažetka opisa svojstava lijeka, naljepnice i upute o lijeku
Sandimmun Neoral was first registered in Germany in February 1993 and is available in the EU as 10 mg, 25 mg, 50 mg, 100 mg soft gelatin capsules and 100 mg/ml oral solution.
EU kao 10 mg, 25 mg, 50 mg, 100 mg mekane želatinaste kapsule i 100 mg/ml oralna otopina.
The dossier of
Dosje lijeka
• the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Budući da • predmet ovog upućivanja je usklađivanje sažetka opisa svojstava lijeka, naljepnice i upute o lijeku
This point was addressed by the MAH and a wording was agreed.
Nositelj odobrenja riješio je ovo pitanje, te je formulacija usuglašena.
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.
CHMP potvrdio je izjavu nositelja odobrenja „Rasponi doze navedeni za oralnu primjenu predviđeni su samo kao smjernice“.
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.
Da bi se postigli usklađeni Sažetci opisa svojstava lijeka, nositelj odobrenja za stavljanje lijeka u promet upotrijebio je formulacije, koje su uobičajene za nacionalne Sažetke opisa svojstava lijeka u većini država članica, i Listu ključnih podataka (CDS, engl.
The CHMP is in agreement with the MAH's position.
CHMP suglasan je s mišljenjem nositelja odobrenja.
The proposed wording was acceptable to the CHMP.
CHMP prihvatio je predloženu formulaciju.
The CHMP was in agreement with the approach taken by the MAH.
CHMP suglasan je s pristupom nositelja odobrenja.
The MAH agreed with the CHMP's opinion and hence revised the wording of the posology in the solid organ transplantation indication accordingly.
a, te je prema tome revidirao formulaciju o doziranju za indikaciju transplantacije organa.
The CHMP was in agreement with the MAH's proposal.
CHMP suglasan je s prijedlogom nositelja odobrenja.
The recommended dose is…
Preporučena doza je...
Find a comfortable, well-lit place.
Nađite udobno i dobro osvijetljeno mjesto.
- Uncontrolled hypertension.
- Nekontrolirana hipertenzija.
Please discuss this with your doctor.
O tome razgovarajte sa svojim liječnikom.
Date of first authorisation: 23 October 2009.
Datum prvog odobrenja: 23. listopada 2009.