natgillin/translations-raw huggingface dataset:
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.
multicentrična študija, v katerih so ciklosporin primerjali s ciklofosfamidom pri bolnikih, odpornih proti steroidnim zdravilom, vendar so jih morali predčasno prekiniti zaradi premajhnega števila primernih bolnikov, ki bi privolili v zdravljenje s placebom ali citostatiki.
However the CHMP considered that this paragraph should be complemented with recommendations for further controls to be made, e.g. of liver function, bilirubin, serum electrolytes and blood pressure and that it is preferred to use glomerular filtration rate determined by a reliable and reproducible method rather than serum creatinine.
bilirubina, elektrolitov v serumu in krvnega tlaka, ter z opombo, da je bolje uporabiti hitrost glomerulne filtracije, določeno z zanesljivo in ponovljivo metodo, kot serumsko koncentracijo kreatinina.
From the data provided and other published data the CHMP concluded that benefit-risk ratio for ciclosporin in treatment of endogenous refractory uveitis, including Behçet uveitis, is positive.
Na podlagi predloženih podatkov in drugih javno dostopnih podatkov je CHMP zaključil, da je razmerje med tveganji in koristmi ciklosporina pri zdravljenju neodzivnega endogenega uveitisa,
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.
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.
In October 2010, Sandimmun Neoral was included in the list of products for Summary of Product Characteristics (SmPC) harmonization, requested by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Oktobra 2010 je bilo zdravilo Sandimmun Neoral vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila (SmPC), ki jo je zahtevala Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini
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 and associated names.
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 in povezanih imen.
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.
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,
Due to the divergent national decisions taken by Member States (MS) concerning the authorization of Sandimmun Neoral (and associated names), the European Commission (EC) notified the EMA/CHMP secretariat of an official referral under Article 30(2) of Directive 2001/83/EC as amended, to resolve divergences amongst the nationally authorised Sandimmun Neoral SmPCs across the EU/EEA region.
EMA/odbora CHMP o uradni napotitvi po členu 30(2) Direktive 2001/83/ES z vsemi spremembami za odpravo neskladij med povzetki glavnih značilnosti zdravila Sandimmun Neoral, odobrenimi na nacionalni ravni na območju EU/EGP.
Additional pharmacokinetics and pharmacodynamics studies, as well as non clinical trials were performed with Sandimmun Neoral medicinal product to support its registration.
V podporo vlogi za registracijo so bile izvedene še dodatne farmakokinetične in farmakodinamične študije ter predklinična preskušanja z zdravilom Sandimmun
Ciclosporin is also used in a variety of conditions that are known, or may be considered, to be of autoimmune origin (endogenous uveitis, nephrotic syndrome, rheumatoid arthritis, psoriasis and atopic dermatitis).
da so avtoimunske (endogeni uveitis, nefrotski sindrom, revmatoidni artritis, psoriaza in atopijski dermatitis).
The MAH addressed the CHMP's concerns; the CHMP is of the view that clinical experience supports the proposed additions in the indication.
Imetnik dovoljenja za promet z zdravilom je odgovoril na zadržke odbora CHMP; slednji meni, da klinične izkušnje kažejo,
Referring to the “non-transplantation indications” section, likewise, the MAH proposed a posology for each of the special populations (i.e. patients with renal impairment, patients with hepatic impairment, paediatric population, elderly population).
Imetnik dovoljenja za promet z zdravilom je pri poglavju „indikacije, ki niso povezane s presaditvijo“ predlagal tudi odmerjanje za vsako od posebnih skupin bolnikov (to so bolniki z okvaro ledvic,
Ciclosporin is contraindicated for some HMG-CoA reductase inhibitors (statins) due to the CYP3A4 and/or Pgp inhibitory potential of ciclosporin.
V skladu z navedenim zgoraj je imetnik dovoljenja za promet z zdravilom za zgoraj omenjeni odstavek predlagal naslednje besedilo na podlagi besedil, uporabljenih v CDS in CSP. Ciklosporin je kontraindiciran za nekatere zaviralce reduktaze HMG-CoA (statine) zaradi možnega zaviralnega učinka na CYP3A4 in/ali P-glikoprotein.
Finally the CHMP also requested the MAH to discuss whether the heading “bone marrow transplantation” shall be updated to “allogenous stem cell transplantation”, i.e. independent from the source (else than non-host) of the stem cells and blasts.
CHMP je prav tako zahteval, da imetnik dovoljenja za promet z zdravilom presodi, ali bi bilo treba naslov „presaditev kostnega mozga" spremeniti v „alogenična presaditev krvotvornih matičnih celic",
Extensive information was provided by the MAH, including the dosages used in clinical studies that supported the approval of Sandimmun and Sandimmun Neoral in the bone marrow transplant indications.
Imetnik dovoljenja za promet z zdravilom je predložil izčrpne podatke, vključno s podatki o odmerkih, uporabljenih v kliničnih študijah, ki so podprli odobritev zdravil Sandimmun in
Therefore, The MAH adhered to the statement on SPC and PL as “This medicinal product does not require any special temperature storage conditions” in accordance with the guideline.
Zato je imetnik dovoljenja za promet z zdravilom v skladu s smernicami upošteval stavek v povzetku glavnih značilnosti zdravila in navodilu za uporabo „Za shranjevanje zdravila ni posebnih temperaturnih omejitev”.
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.
Po pregledu nabora podatkov je CHMP menil, da je predlagano odmerjanje pri indikaciji presaditev kostnega mozga, ki je odobreno v 16
The MAH proposed a wording that was approved in between 18 an 24 MS, depending on subsections.
Imetnik dovoljenja za promet z zdravilom je predlagal besedilo, ki je že bilo odobreno v 18 do 24
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.
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
A new wording was proposed by the MAH and agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom je predlagal novo besedilo, ki ga je CHMP odobril.
• Solid organ transplantation
• Presaditev kostnega mozga
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holder(s) 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).
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.
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.
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi 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.
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.
CDS) za zdravilo Sandimmun Neoral (z dne 13. februarja 2012), ter predložil starejše študije in referenčno literaturo.
In addition, the MAH proposed a correction in the wording of the “Special precautions for storage” in the SmPC for Sandimmun 50 mg/ml concentrate for solution for infusion, also in conformance to the above-mentioned Guideline.
50 mg/ml koncentrat za raztopino za injiciranje, ki je prav tako v skladu z omenjenimi smernicami.
The daily doses of Sandimmum 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 je odobril stavek imetnika dovoljenja „razpone odmerkov za peroralno uporabo je treba upoštevati zgolj kot smernice“.
All MS except Norway have the indication bone marrow transplantation and GVHD approved.
Indikacija presaditev kostnega mozga in GVHD je odobrena v vseh državah članicah, razen na
In November 2011, a full review of the company label (CDSs for both products Sandimmun and Sandimmun Neoral) was initiated.
Novembra 2011 se je začel natančen pregled dokumentov družbe (krovnih dokumentov za zdravili
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.
13. februarja 2012 ter predlagal besedilo, ki je že odobreno v 13 državah članicah EU.
Its side effects seem manageable.
Njegovi neželeni učinki se zdijo obvladljivi.
The maximum dose is 90 mg every two weeks.
Največji odmerek je 90 mg vsaka dva tedna.
What measures are being taken to ensure the safe and effective use of Crysvita?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Crysvita?
All the children received Crysvita either every two weeks or every four weeks.
Vsi otroci so zdravilo Crysvita prejemali bodisi vsaka dva tedna bodisi vsake štiri tedne.
This is a summary of the European public assessment report (EPAR) for Crysvita.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Crysvita.
The average score before treatment was 1.9 points in those given Crysvita every 2 weeks, and this fell by 1.0 point after 64 weeks of treatment; in those given the medicine every 4 weeks the baseline score of 1.7 fell by 0.8 point.
Povprečna ocena pred zdravljenjem je bila pri bolnikih, ki so zdravilo Crysvita prejemali vsaka dva tedna, 1,9 točke in se je po 64 tednih zdravljenja zmanjšala za 1,0 točke; pri tistih, ki so zdravilo prejemali vsake štiri tedne, pa se je izhodiščna ocena 1,7 zmanjšala za 0,8 točke.
Side effects with Crysvita (which may affect more than 1 in 10 people) are injection site reactions (such as skin redness, itching, rash, pain and bruising), headache, pain in arms and legs, decreased vitamin D level, rash, toothache, tooth abscess, muscle pain and dizziness.
Neželeni učinki zdravila Crysvita (ki se lahko pojavijo pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja (npr. pordelost kože, izpuščaj, srbenje, bolečina in podplutbe), glavobol, bolečine v rokah in nogah, zmanjšana raven vitamina D, izpuščaj, zobobol, zobni absces, bolečine v mišicah ter omotica.
The European Medicines Agency therefore decided that Crysvita's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Crysvita večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
The medicine was assessed in one main ongoing study in 52 children aged between 5 and 12 years.
Zdravilo je bilo ocenjeno v eni glavni študiji, ki še poteka, pri 52 otrocih, starih od 5 do 12 let.
The main measure of effectiveness was a reduction in the severity of rickets (bone deformities) in the wrist and knee measured on a scale from 0 (normal) to 10 (severe).
Glavno merilo učinkovitosti je bila zmanjšana resnost rahitisa (kostnih deformacij) zapestja in kolena, merjena z lestvico od 0 (normalno) do 10 (resno).
What is Crysvita and what is it used for?
Kaj je zdravilo Crysvita in za kaj se uporablja?
The recommended dose at the start of treatment is 0.4 mg per kg of body weight, and then 0.8 mg/kg every two weeks to continue treatment.
Priporočeni začetni odmerek je 0,4 mg/kg telesne mase, nato pa se zdravljenje nadaljuje z odmerkom 0,8 mg/kg vsaka dva tedna.
The summary of the opinion of the Committee for Orphan Medicinal Products for Crysvita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Crysvita je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
In addition, phosphate levels in the blood improved over time in both groups, particularly those given Crysvita every 2 weeks.
Poleg tega so se ravni fosfatov v krvi sčasoma popravile v obeh skupinah, predvsem pri bolnikih, ki prejemajo zdravilo Crysvita vsaka dva tedna.
It is used if signs of bone disease are seen on X-rays.
Uporablja se, če so na rentgenskih posnetkih vidni znaki bolezni kosti.
The medicine can only be obtained with a prescription and treatment should be started by a doctor experienced in the management of patients with bone diseases caused by alterations in the body's chemical processes.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z obravnavanjem bolnikov z boleznimi kosti, ki jih povzročajo spremembe v kemičnih procesih v telesu.
Phosphate is essential to build bones and teeth and to maintain their strength, so patients may develop rickets and other bone deformities and growth problems.
Fosfati so nujni za izgradnjo kosti in zob ter za ohranjanje njihove čvrstosti, zato lahko pri teh bolnikih pride do rahitisa in drugih deformacij kosti ter težav z rastjo.
Other information about Crysvita
Druge informacije o zdravilu Crysvita
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Crysvita have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Crysvita upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Crysvita, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Crysvita preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Crysvita has been given ‘conditional approval'.
Zdravilo Crysvita je pridobilo „pogojno dovoljenje za promet“.
Crysvita can be used in children over 1 year of age and adolescents with growing skeletons.
Zdravilo Crysvita se lahko uporablja pri otrocih, starejših od enega leta, in pri mladostnikih v obdobju rasti okostja.
What benefits of Crysvita have been shown in studies?
Kakšne koristi je zdravilo Crysvita izkazalo v študijah?
The full EPAR for Crysvita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Crysvita je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What are the risks associated with Crysvita?
Kakšna tveganja so povezana z zdravilom Crysvita?
Crysvita is given as an injection under the skin.
Zdravilo Crysvita se daje z injiciranjem pod kožo.
Why is Crysvita approved?
Zakaj je bilo zdravilo Crysvita odobreno?
Since Crysvita has been granted a conditional approval, the company that markets Crysvita will provide updated results from two ongoing studies in children aged between 5 and 12 years and between 1 and 4 years.
Ker je zdravilo Crysvita pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila posodobljene rezultate dveh študij, ki še potekata, pri otrocih, starih od 5 do 12 let in od 1 do 4 let.
Phosphate levels are largely controlled by the kidneys, which either remove excess phosphate or reabsorb it into the bloodstream when needed.
Ravni fosfatov uravnavajo predvsem ledvice, ki bodisi odstranjujejo čezmerne fosfate bodisi jih reabsorbirajo v kri, kadar je to potrebno.
For practical information about using Crysvita, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Crysvita naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is not intended to provide practical advice on how to use Crysvita.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
An additional ongoing study in 13 younger children shows that Crysvita is effective in those aged between 1 and 4 years.
Dodatna študija, ki prav tako še poteka, pri 13 mlajših otrocih je pokazala, da je zdravilo Crysvita učinkovito pri otrocih, starih od 1 do 4 let.
Because the number of patients with X-linked hypophosphataemia is low, the disease is considered ‘rare', and Crysvita was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 October 2014.
Ker je bolnikov z na kromosom X vezano hipofosfatemijo malo, velja ta bolezen za redko, zato je bilo zdravilo Crysvita 15. oktobra 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Crysvita is a monoclonal antibody (a type of protein) designed to recognise and attach to the FGF23 protein.
Zdravilo Crysvita je monoklonsko protitelo (vrsta beljakovine), zasnovano za prepoznavo beljakovine FGF23 in vezavo nanjo.
For the full list of restrictions with Crysvita see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Crysvita glejte navodilo za uporabo.
The dose is adjusted according to the patient's phosphate levels in the blood.
Odmerek je treba prilagoditi bolnikovim ravnem fosfatov.
What information is still awaited for Crysvita?
Katere informacije o zdravilu Crysvita še pričakujemo?
By attaching to the FGF23 protein, the medicine blocks its activity, allowing the kidneys to reabsorb phosphate and restore normal levels of phosphate in the blood.
Zdravilo z vezavo na beljakovino FGF23 zavira njeno delovanje, s čimer ledvicam omogoča reabsorpcijo fosfatov in obnovo normalnih ravni fosfatov v krvi.
The company is also required to conduct and submit the results of a study comparing Crysvita with oral phosphate and vitamin D in children aged between 1 and 12 years with X-linked hypophosphataemia.
Družba mora tudi izvesti študijo, v kateri bodo zdravilo Crysvita primerjali s peroralnimi fosfati in vitaminom D pri otrocih, starih od 1 do 12 let, z na kromosom X vezano hipofosfatemijo, ter predložiti njene rezultate.
Patients with X-linked hypophosphataemia have abnormally high levels of a protein called FGF23 which causes the kidneys to stop reabsorbing phosphate into the bloodstream.
Bolniki z na kromosom X vezano hipofosfatemijo imajo nenormalno visoke ravni beljakovine FGF23, ki povzroča, da ledvice prenehajo reabsorbirati fosfate v krvni obtok.
Crysvita is a medicine used for the treatment of X-linked hypophosphataemia, a hereditary disorder characterised by low levels of phosphate in the blood (hypophosphataemia).
Crysvita je zdravilo, ki se uporablja za zdravljenje na kromosom X vezane hipofosfatemije, dedne motnje, za katero so značilne nizke ravni fosfatov v krvi (hipofosfatemija).
Crysvita reduced the severity of rickets as shown in X-rays in children with X-linked hypophosphataemia.
Zdravilo Crysvita je zmanjšalo resnost rahitisa, razvidno z rentgenskih posnetkov otrok z na kromosom X vezano hipofosfatemijo.
How is Crysvita used?
Kako se zdravilo Crysvita uporablja?
Crysvita was shown to reduce the severity of bone deformities in the wrist and knee and improve the level of phosphate in the blood of children with X-linked hypophosphataemia in one ongoing study, and further data are awaited.
V eni študiji, ki še poteka, se je izkazalo, da zdravilo Crysvita zmanjšuje resnost kostnih deformacij zapestja in kolena ter povečuje raven fosfatov v krvi otrok z na kromosom X vezano hipofosfatemijo, pričakujejo pa se še nadaljnji podatki.
Crysvita contains the active substance burosumab.
Zdravilo Crysvita vsebuje zdravilno učinkovino burosumab.
How does Crysvita work?
Kako zdravilo Crysvita deluje?
Also, Crysvita must not be used in patients with high phosphate levels in the blood or in patients with severe kidney disease.
Med zdravljenjem z zdravilom Crysvita se ne smejo uporabljati peroralna zdravila, ki vsebujejo fosfate ali vitamin D. Zdravilo Crysvita se poleg tega ne sme uporabljati pri bolnikih z visoko ravnijo fosfatov v krvi ali pri bolnikih s hudo boleznijo ledvic.
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):
Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic bodo zagotovili, kadar je to primerno, da imetnik(i) dovoljenja za promet z zdravilom izpolni(jo) naslednje pogoje:
The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Imetniki dovoljenja za promet z zdravilom morajo ugotoviti specifično populacijo bolnikov, pri kateri so koristi zdravila večje od ugotovljenega tveganja.
Conditions for lifting the suspension of the marketing authorisation
Pogoji za preklic začasnega umika dovoljenja za promet z zdravilom
Annex IV Conditions for lifting the suspension of the marketing authorisation
Priloga IV Pogoji za preklic začasnega umika dovoljenja za promet z zdravilom
Initiation pack: 28 tablets (7 x 90 mg + 21 x 180 mg)
90 mg + 180 mg začetno pakiranje: 28 tablete (7 x 90 mg + 21 x 90 mg)
Your doctor will assess you carefully.
Vaš zdravnik vas bo natančno ocenil.
This pack is intended to be used for the first 10 days of treatment.
To pakiranje je namenjeno za uporabo v prvih 10 dneh zdravljenja.
Start of treatment (first 4 weeks):
Začetek zdravljenja (prvi 4 tedni):
Interaction studies have only been performed in adults.
Študije medsebojnega delovanja so izvedli samo pri odraslih.