natgillin/translations-raw huggingface dataset:
Chenodeoxycholic acid Leadiant is unlikely to cause serious side effects.
Zdravilo Henodeoksiholna kislina Leadiant običajno ne povzroči resnih neželenih učinkov.
The divided dose when given three times a day = 15 mg = 5 mg
Razdeljen odmerek pri dajanju trikrat na dan = 15 mg = 5 mg
The active substance will be dissolved in the sodium bicarbonate solution and as not all the contents of the capsule will be dissolved it appears as a mixture.
Celotna vsebina kapsule se ne bo raztopila, zaradi česar bo videti kot mešanica.
Package leaflet: Information for the user Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid This medicine is subject to additional monitoring.
Navodilo za uporabo Henodeoksiholna kislina Leadiant 250 mg trde kapsule henodeoksiholna kislina Za to zdravilo se izvaja dodatno spremljanje varnosti.
Elderly patients (≥ 65 years)
Posebne skupine bolnikov Starejši bolniki (≥ 65 let) Prilagajanje odmerka ni potrebno.
Where the dose calculated is not a multiple of 250 mg, the nearest dose below the maximum of 15 mg/kg/day should be selected, provided that is sufficient to normalise serum cholestanol and/or urine bile alcohols.
Kjer izračunan odmerek ni večkratnik 250 mg, je treba izbrati najbližji odmerek, manjši od največ 15 mg/kg/dan, pod pogojem,
The divided dose when given three times a day = 150 mg = 50 mg
Razdeljen odmerek pri dajanju trikrat na dan = 150 mg = 50 mg
It is not recommended to take Chenodeoxycholic acid Leadiant during pregnancy and breast-feeding.
Jemanje henodeoksiholne kisline med nosečnostjo in dojenjem ni priporočljivo.
The net result is a total bile acid pool that is severely deficient in chenodeoxycholic acid but relatively enriched with cholic acid.
Skupni rezultat je zbir čiste žolčne kisline s hudim pomanjkanjem henodeoksiholne kisline, vendar z veliko holne kisline.
For babies, children and those who cannot swallow capsules and/or need to take a dose below 250 mg, a capsule may be opened and the contents mixed with 8.4% sodium bicarbonate solution.
Za dojenčke, otroke in tiste, ki ne morejo pogoltniti kapsule in/ali morajo vzeti odmerek pod 250 mg lahko kapsule odprete in vsebino zmešate z raztopino 8,4 % natrijevega bikarbonata.
Dose calculation (Infants 1month-1yr) chenodeoxycholic acid 5 mg/mL suspension Daily dose:
Izračun odmerka (otroci 1 mesec-1 leto) suspenzije henodeoksiholne kisline 5 mg/ml za bolnika Dnevni odmerek:
One instance of mild intermittent constipation occurred in an adult and another instance occurred in a child. One instance of hepatic adverse reactions occurred in a two week old infant diagnosed with CTX and is discussed in the section below.
En primer neželenih učinkov na jetra se je pojavil pri dvotedenskem dojenčku z diagnozo CTX in je obravnavan v nadaljevanju.
Exogenous replacement with Chenodeoxycholic acid inhibits CYP7A1 (via nuclear receptor, FXR) and HMG CoA reductase, thus restoring the feedback inhibition.
Eksogena zamenjava s henodeoksiholno kislino inhibira CYP7A1 (prek jedrskega receptorja, FXR) in HMG CoA
What Chenodeoxycholic acid Leadiant is and what it is used for
Kaj je zdravilo Henodeoksiholna kislina Leadiant in za kaj ga uporabljamo
Chenodeoxycholic acid Leadiant 250 mg hard capsules
Henodeoksiholna kislina Leadiant 250 mg trde kapsule
The administration of oral contraceptives reduces the pool size of chenodeoxycholic acid.
Dajanje peroralnih kontraceptivov zmanjša velikost vzorcev henodeoksiholne kisline.
10 kg patient on a dose of 15 mg/kg of chenodeoxycholic acid.
Bolnik z maso 10 kg za odmerek 15 mg/kg henodeoksiholne kisline.
3 kg patient on a dose of 5 mg/kg of chenodeoxycholic acid.
Bolnik z maso 3 kg za odmerek 5 mg/kg henodeoksiholne kisline.
Chenodeoxycholic acid should be taken either one hour before cholestyramine or 4-6 hours after.
morate vzeti henodeoksiholno kislino eno uro pred holestiraminom ali 4-6 ur kasneje.
Chenodeoxycholic acid Leadiant is available in blister packs containing 100 hard capsules.
Zdravilo Henodeoksiholna kislina Leadiant je na voljo v pretisnih omotih po 100 trdih kapsul.
The active substance itself will be dissolved in the sodium bicarbonate solution and it appears as a suspension because not all components of the capsule contents will be dissolved.
Videti je kot suspenzija, ker se vse komponente vsebine kapsule ne raztopijo.
If you have to take colestyramine then take Chenodeoxycholic acid Leadiant either one hour before colestyramine or 4-6 hours after.
Če morate vzeti holestiramin, vzemite zdravilo Henodeoksiholna kislina Leadiant ali eno uro pred holestiraminom ali 4-6 ur kasneje.
(Weight in kg) x (Dose in mg/kg) = Daily dose in mg
(Masa v kg x odmerek v mg/kg) = dnevni odmerek v mg Deljen odmerek* (Dnevni odmerek v mg) = Deljen odmerek v mg (Pogostost odmerka)
What Chenodeoxycholic acid Leadiant looks like and contents of the pack
Izgled zdravila Henodeoksiholna kislina Leadiant in vsebina pakiranja
Pharmacotherapeutic group: Alimentary tract and metabolism - Bile therapy - Bile acid preparations, ATC code: A05AA01
Žolčne kisline, oznaka ATC: A05AA01
The capsules should be swallowed whole with water at approximately the same time each day.
250 mg kapsula štirikrat na dan. Kapsule je treba pogoltniti cele z vodo vsak dan ob približno istem času.
If you take more Chenodeoxycholic acid Leadiant than you should
Če ste vzeli večji odmerek zdravila Henodeoksiholna kislina Leadiant, kot bi smeli
Dose adjustment is not necessary.
Navedba smiselno ni potrebna.
Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid
Henodeoksiholna kislina Leadiant 250 mg trde kapsule henodeoksiholna kislina
For infants the capsules may be opened and the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Za dojenčke se kapsule lahko odprejo in se vsebina doda v 50 ml raztopine natrijevega bikarbonata 8,4 % (1 mmol/ml), ki se premeša, da dobimo suspenzijo, ki vsebuje 5 mg/ml henodeoksiholne kisline.
There are no or limited amount of data from the use of chenodeoxycholic acid in pregnant women.
Za uporabo henodeoksiholne kisline pri nosečnicah ni podatkov ali je na voljo omejena količina podatkov.
Chenodeoxycholic acid Leadiant
Henodeoksiholna kislina Leadiant
Titanium dioxide Quinoline yellow Erythrosine
Ovojnica kapsule želatina titanov dioksid kinolinsko rumeno eritrozin
If administration of ciclosporin or sirolimus is considered necessary, serum and urine bile alcohol levels should be closely monitored and the chenodeoxycholic acid dose adjusted accordingly.
Če je potrebno zdravljenje s ciklosporinom ali sirolimusom, je treba skrbno spremljati ravni seruma in žolčnih alkoholov v urinu in odmerek henodeoksiholne kisline ustrezno prilagoditi.
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
- The active substance is chenodeoxycholic acid.
- Učinkovina je henodeoksiholna kislina.
Other medicines and Chenodeoxycholic acid Leadiant
Druga zdravila in zdravilo Henodeoksiholna kislina Leadiant
In the supportive study CDCA-STRCH-CR-14-001 treatment of CTX patients with chenodeoxycholic acid 750 mg/day given for a median duration of 5.75 years was associated with statistically significant decreases in mean serum levels of cholestanol from baseline to any post-baseline visit.
750 mg/dan za mediano trajanje 5,75 let, je bilo povezano statistično pomembno znižanje povprečnega seruma holestanola od izhodišča pri vsakem kasnejšem obisku.
If administration of phenobarbital is considered necessary, serum and urine bile alcohol levels should be closely monitored and the chenodeoxycholic acid dose adjusted accordingly.
Če je potrebno zdravljenje s fenobarbitalom, je treba skrbno spremljati ravni seruma in žolčnih alkoholov v urinu in odmerek henodeoksiholne kisline ustrezno prilagoditi.
Divided dose*
Celotni dnevni odmerek =
If you stop taking Chenodeoxycholic acid Leadiant
Če prenehate jemati zdravilo Henodeoksiholna kislina Leadiant
Breast-feeding It is unknown whether chenodeoxycholic acid/metabolites are excreted in human milk.
Ni znano, ali se henodeoksiholna kislina/presnovki izločajo v materino mleko.
For children, adolescents and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsules may be opened and the contents added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 10 mg/mL.
Za otroke, mladostnike in odrasle, ki ne morejo pogoltniti kapsule in/ali morajo vzeti odmerek pod 250 mg, se kapsule lahko odprejo in se vsebina doda v 25 ml raztopine natrijevega bikarbonata 8,4 % (1 mmol/ml), ki se premeša, da dobimo suspenzijo, ki vsebuje 10 mg/ml henodeoksiholne kisline.
If you forget to take Chenodeoxycholic acid Leadiant
Če ste pozabili vzeti zdravilo Henodeoksiholna kislina Leadiant
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER PACKS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Co-administration with oral contraceptives is not recommended.
Sočasna uporaba peroralnih kontraceptivov ni priporočljiva.
(Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg) x 1 ml = Amount of suspension to give
(Masa v kg) x (odmerek v mg/kg) = dnevni odmerek v mg Deljen odmerek* (Dnevni odmerek v mg) = Deljen odmerek v mg Pogostost odmerka
For children, adolescents and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsule may be opened, the contents of added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 10 mg/mL.
Za otroke, mladostnike in odrasle, ki ne morejo pogoltniti kapsule in/ali morajo vzeti odmerek pod 250 mg, se kapsula odpre in vsebini dodamo 25 ml raztopine natrijevega bikarbonata 8,4 % (1 mmol/ml), da dobimo suspenzijo, ki vsebuje 10 mg/ml henodeoksiholne kisline.
In order to collect long term safety and efficacy data in patients treated with Protocol - by chenodeoxycholic acid, the MAH will submit the results of a study deriving from a registry of patients with inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Za zbiranje dolgoročnih podatkov o varnosti in učinkovitosti pri bolnikih, ki se zdravijo z henodeoksiholno kislino, bo imetnik dovoljenja za promet predložil rezultate študije, ki izhaja iz registra bolnikov z prirojenimi napakami pri
How to store Chenodeoxycholic acid Leadiant 6.
Shranjevanje zdravila Henodeoksiholna kislina Leadiant 6.
Chenodeoxycholic acid Leadiant is provided as hard capsules.
Zdravilo Henodeoksiholna kislina Leadiant je na voljo v obliki trdih kapsul.
Chenodeoxycholic acid given orally is absorbed in the small intestine.
Peroralno zaužita henodeoksiholna kislina se absorbira v tankem črevesu.
It is not recommended to take oral contraceptives whilst taking Chenodeoxycholic acid Leadiant.
Uporaba peroralnih kontraceptivov se ne priporoča pri bolnikih, ki jemljejo henodeoksiholno kislino.
If you get any side effects, talk to your doctor or, pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Each hard capsule contains 250 mg of chenodeoxycholic acid.
Ena trda kapsula vsebuje 250 mg henodeoksiholne kisline.
- Each capsule contains 250 mg of chenodeoxycholic acid.
- Ena kapsula vsebuje 250 mg henodeoksiholne kisline.
Special populations
V IZJEMNIH OKOLIŠČINAH
Do not stop taking Chenodeoxycholic acid Leadiant without first speaking with your doctor.
Leadiant, brez da bi se predhodno posvetovali s svojim zdravnikom.
How to take Chenodeoxycholic acid Leadiant
Kako jemati zdravilo Henodeoksiholna kislina Leadiant
Magnesium stearate Silica, colloidal anhydrous Water
Vsebina kapsule koruzni škrob magnezijev stearat brezvodni koloidni silicijev dioksid voda
Each capsule contains 250 mg chenodeoxycholic acid.
Ena kapsula vsebuje 250 mg henodeoksiholne kisline.
Colestipol or antacid medicinal products containing aluminium hydroxide and/or smectite should be taken either 2 hours before or after taking chenodeoxycholic acid.
Holestipol ali antacidna zdravila, ki vsebujejo aluminijev hidroksid in/ali smektit je treba jemati bodisi
(Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg x 1 ml) = Amount of suspension to give
(Razdeljen odmerek v mg 1 ml) = Količina odmerjene suspenzije
You should contact your doctor for advice if you or your child has taken more than the amount prescribed.
Če ste vi ali vaš otrok vzeli prevelik odmerek se morate posvetovati s svojim zdravnikom.
Babies
Dojenje
Effects of chenodeoxycholic acid with other medicinal products Co-administration with ciclosporin, sirolimus, phenobarital is not recommended, see section 4.5 for further details.
Sočasna uporaba s ciklosporinom, sirolimusom in fenobarbitalom ni priporočljiva.
This was confirmed within the framework of this article 30 procedure.
To so v okviru tega postopka v skladu s členom 30 potrdili.
The stability data at these testing conditions has shown that the results are within the acceptance criteria and the product is stable.
Podatki o stabilnosti pri teh preskusnih pogojih so pokazali, da so rezultati znotraj merila sprejemljivosti in da je zdravilo stabilno.
Overall summary of the scientific evaluation of Sandimmun and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Sandimmun in povezanih imen (glejte Prilogo I)
Moreover, recent trials have confirmed the benefit of Sandimmun in different forms of nephrotic syndrome in children and adults.
Poleg tega so v nedavnih preskušanjih potrdili koristi zdravila Sandimmun pri različnih oblikah nefrotskega sindroma pri otrocih in odraslih.
Whereas
EU.
The MAH proposed wordings for the sub-sections “Absorption, Distribution, Biotransformation and Elimination, Special populations and Paediatric population.” based on a harmonized text already approved in 13 EU countries.
Porazdelitev, Biotransformacija in izločanje, Posebne skupine bolnikov in Pediatrična populacija“, ki temeljijo na usklajenem besedilu, ki je že odobreno v 13 državah EU.
The registration of Sandimmun Neoral was based on efficacy and safety data from clinical studies performed with the oil-based formulation (Sandimmun), first registered in Switzerland in December 1982.
Registracija zdravila Sandimmun Neoral je temeljila na podatkih o učinkovitosti in varnosti iz kliničnih študij, izvedenih s pripravkom na oljni osnovi (Sandimmun), ki je bil prvič registriran decembra 1982 v Švici.
The MAH therefore agreed to revise the wording, recommending that Sandimmun should be administered on a consistent schedule with regard to time of day and relation to meals, as follows: “The daily doses of Sandimmun/Sandimmun Neoral always should be given in two divided doses equally distributed throughout the day, taken at the same time of the day, e.g., in the morning and in the evening.
Imetnik dovoljenja za promet z zdravilom se je zato strinjal s spremembo besedila in priporočil jemanje zdravila Sandimmun po ustaljenem urniku glede na čas dneva in obroke hrane, kot sledi: „Dnevne odmerke zdravila Sandimmun/Sandimmun Neoral je treba vedno dati v dveh deljenih odmerkih, enakomerno porazdeljenih čez dan, ki jih je treba vzeti ob istem času, na primer zjutraj in zvečer.
Sandimmun is an oil-based formulation of ciclosporin.
Sandimmun je pripravek ciklosporina na oljni osnovi.
However the statement “The daily doses of Sandimmum 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).
Stavek „dnevne odmerke zdravila Sandimmun je treba vedno dati v dveh deljenih odmerkih“ pa je CHMP odobril le delno, saj bi bilo treba besedo „vedno“ izpustiti (v nekaterih primerih je namreč potrebno odmerjanje trikrat na dan).
The indication aplastic anemia is only approved in France.
• Aplastična anemija Indikacija aplastična anemija je odobrena samo v Franciji.
The MAH confirmed that the stability studies have been performed at the long term conditions at 25°C/60%RH and accelerated conditions also at 40°C/75% RH.
Imetnik dovoljenja za promet z zdravilom je potrdil, da so bile stabilnostne študije izvedene v realnih pogojih pri 25 °C/60 % relativni vlažnosti in pospešenih pogojih pri 40 °C/75 % relativni vlažnosti.
The MAH confirmed that the storage conditions in the SmPCs of Sandimmun soft gelatin capsules and oral solutions are already aligned with the requirements set in the Guideline on Declaration of Storage Conditions (CPMP/QWP/609/96/Rev 2 dated 19 Nov 2007).
Imetnik dovoljenja za promet z zdravilom je potrdil, da so pogoji shranjevanja v povzetku glavnih značilnosti zdravila za zdravilo Sandimmun v obliki mehkih želatinastih kapsul in peroralne raztopine že usklajeni z zahtevami smernic za navajanje pogojev shranjevanja (CPMP/QWP/609/96/Rev 2 z dne 19. novembra 2007).
It is recommended that Sandimmun be administered on a consistent schedule with regard to time of day and relation to meals.
Priporoča se, da se zdravilo Sandimmun jemlje po ustaljenem urniku glede na čas dneva in obroke hrane. "
The dossier of Sandimmun was used as a basis of the review as the dossier supporting the approval of the new ciclosporin formulation (Sandimmun Neoral) was based on pharmacokinetics evaluation that demonstrated equivalence between the 2 forms of ciclosporin (oil-based formulation versus microemulsified formulation).
Dokumentacijo zdravila Sandimmun so kot podlago za pregled uporabili zato, ker je dokumentacija v podporo vlogi za odobritev novega pripravka ciklosporina (Sandimmun Neoral) temeljila na farmakokinetičnih podatkih, ki so pokazali enakovrednost obeh oblik ciklosporina (pripravka na oljni osnovi in mikroemulzije).
The agreed Core Safety profile (CSP) from the last PSUR 13 work sharing procedure (EE/H/PSUR/0007/001) and the public AR from the paediatric article 45 procedure (CZ/W/04/pdWS/01, 2010) were also used.
PSUR 13 (EE/H/PSUR/0007/001), in poročilo o oceni zdravila iz postopka delitve dela za uporabo zdravil v pediatriji po členu 45 (CZ/W/04/pdWS/01, 2010).
In addition, Sandimmun Neoral produces a more uniform exposure to ciclosporin throughout the day and from day to day on a maintenance regimen.
Neoral zagotavlja enakomernejšo izpostavljenost ciklosporinu čez dan in od enega do drugega dneva pri vzdrževalnem zdravljenju.
Ciclosporin is a potent immunosuppressive agent used in human solid organ and bone marrow transplantation to prevent graft rejection and in Graft Versus Host Disease (GVHD).
Ciklosporin je močan imunosupresiv, ki se uporablja pri presaditvah parenhimskih organov in kostnega mozga pri ljudeh za preprečevanje zavrnitve presadka in reakcije presadka proti gostitelju (Graft Versus Host Disease - GVHD).
The MAH proposed two different wordings for each of the paragraphs on transplantation:
Imetnik dovoljenja za promet z zdravilom je predlagal dve različni besedili za vsakega od odstavkov o presaditvi: • Presaditev parenhimskih organov
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).
Poglavja od 4.3 do 4.9 - od „Kontraindikacije“ do „Preveliko odmerjanje“ Imetnik dovoljenja za promet z zdravilom je k predlagani uskladitvi poglavij povzetka glavnih značilnosti zdravila, povezanih z varnostjo (poglavja od 4.3 do 4.9), pristopil tako, da je za osnovo uporabil najnovejšo različico krovnega dokumenta družbe (CDS) za zdravilo Sandimmun Neoral z dne 13. februarja 2012 (kar je podprl tudi pregled predloženih starejših študij in referenčne literature) in končno različico dokumenta „Ključne informacije o varnosti zdravila“ (CSP), ki je bil sprejet v okviru zadnjega postopka delitve dela pri oceni PSUR 13 (EE/H/PSUR/0007/001).
The MAH presented respectively the clinical efficacy outcome of the US and Canada studies and then the European studies.
Združenih državah in Kanadi ter nato še iz evropskih študij.
Based on the above the CHMP considers the benefit/risk ratio of Sandimmun to be favourable and the harmonised PI to be approvable.
Na podlagi naštetega je odbor CHMP menil, da je razmerje med tveganji in koristmi zdravila Sandimmun ugodno in da se usklajene informacije o zdravilu lahko odobrijo.
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.
Zdravilo Sandimmun Neoral je bilo prvič registrirano v Nemčiji februarja 1993 in je v EU na voljo v obliki mehkih želatinastih kapsul (10 mg, 25 mg, 50 mg in 100 mg) ter peroralne raztopine
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.
14-18 mg/kg/dan, ki so jih postopoma zmanjševali do vzdrževalnega odmerka v razponu od 6-10 mg/kg/dan.
Finally the MAH was also requested to update this section with more information concerning the inhibitory potential of ciclosporin on other transporters than P-gp.
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.
The MAH proposed wordings for the sub-sections “Food interactions, Drug interactions, Drugs that decrease ciclosporin levels, Drugs that increase ciclosporin levels, Other relevant drug interactions, Recommendations, Paediatric population and Other relevant drug interactions.”
Imetnik dovoljenja za promet z zdravilom je predlagal besedila za podpoglavja „Medsebojno delovanje s hrano, Medsebojno delovanje z drugimi zdravili, Zdravila, ki znižujejo koncentracije ciklosporina, Zdravila, ki zvišujejo koncentracije ciklosporina, Druge pomembne interakcije,
The CHMP noted that Marketing Authorisations for Sandimmum and associated names 50mg/ml concentrate for solution for infusion are solely granted for the above-mentioned transplantation indications (namely, the solid organ transplantation and the bone marrow transplantation).
• Sandimmun in povezana imena 50 mg/ml koncentrat za raztopino za infundiranje CHMP je ugotovil, da so dovoljenja za promet z zdravilom Sandimmun in povezanimi imeni 50 mg/ml koncentrat za raztopino za infundiranje odobrena samo za zgoraj omenjeni indikaciji, povezani s presaditvijo (tj. presaditev parenhimskih organov in presaditev kostnega mozga).
The CHMP is of the view that introducing Sandimmun for the treatment of rejection is most appropriate for cellular rather than humoral rejection, based on the mechanism of action of CNI's.
CHMP je menil, da je glede na mehanizem delovanja zaviralcev kalcinevrina uporaba zdravila Sandimmun za zdravljenje zavrnitve primernejša pri celični kot pri humoralni zavrnitvi.
The MAH proposed the following wording for this indication: “Sandimmun 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.
Imetnik dovoljenja za promet z zdravilom je za to indikacijo predlagal naslednje besedilo: „Zdravilo Sandimmun je indicirano pri bolnikih s hudim atopijskim dermatitisom, ki potrebujejo sistemsko zdravljenje. "
The review of the original Sandimmun Dossiers from major markets such as France, the U.S. and UK which contains the clinical results from a total of 15 global studies has been performed.
Združene države in Združeno kraljestvo, ki vsebuje klinične podatke iz skupno 15 globalnih študij.