natgillin/translations-raw huggingface dataset:
After treatment with chenodeoxycholic acid, the endogenous synthesis of the primary bile acids, cholic acid and chenodeoxycholic acid, is inhibited.
Nakon liječenja kenodeoksikolatnom kiselinom, endogena sinteza primarnih žučnih kiselina, kolatne kiseline i kenodeoksikolatne kiseline,
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.
U potpornom ispitivanju CDCA-STRCH-CR-14-001 liječenje bolesnika s CTX-om kenodeoksikolatnom kiselinom u dozi od 750 mg/dan davanom u medijanu trajanja od 5,75 godina bilo je povezano sa statistički značajnim smanjenjem srednjih vrijednosti serumskih razina kolestanola u usporedbi između početnih vrijednosti i bilo kojeg kasnijeg posjeta.
In the pivotal study CDCA-STUK-15-001 treatment of CTX patients with chenodeoxycholic acid 7501000 mg/day in adults or 5-15 mg/kg/day in infants and children was associated with statistically significant decreases in mean serum levels of cholestanol from baseline to post-baseline in the overall population and in the two subgroups of patients aged < 21 years or ≥ 21 years at first treatment.
U pivotalnom ispitivanju CDCA-STUK-15-001 liječenje bolesnika s CTX-om kenodeoksikolatnom kiselinom u dozi od 750-1000 mg/dan za odrasle ili 5-15 mg/kg/dan za dojenčad i djecu bilo je povezano sa statistički značajnim smanjenjem srednjih vrijednosti kolestanola u serumu od početnih vrijednosti do vrijednosti nakon početka liječenja u cjelokupnoj populaciji, kao i u dvije podskupine bolesnika u dobi
The net result is a total bile acid pool that is severely deficient in chenodeoxycholic acid but relatively enriched with cholic acid.
Krajnji rezultat je ukupna količina žučnih kiselina u tijelu kojoj znatno nedostaje kenodeoksikolatna kiselina, ali koja je prilično obogaćena kolatnom kiselinom.
Deconjugation results in the free bile acid, oxidation in the 7-keto-lithocholic acid and lithocholic acid (3α-hydroxycholanic acid) is formed by elimination of the 7-hydroxy group.
Dekonjugacijom nastaju slobodne žučne kiseline, oksidacijom 7-keto-litokolatna kiselina, a litokolatna kiselina (3α-hidroksikolanatna kiselina) stvara se eliminacijom 7-hidroksi skupine.
Chenodeoxycholic acid Leadiant is unlikely to cause serious side effects.
Chenodeoxycholic acid Leadiant najvjerojatnije neće uzrokovati ozbiljne nuspojave.
Women should use an effective contraceptive method whilst taking Chenodeoxycholic acid Leadiant.
Žene trebaju koristiti učinkovitu kontracepciju dok uzimaju lijek Chenodeoxycholic acid Leadiant.
The correct volumes should preferably be marked on the oral syringe.
Poželjno je da na štrcaljki za usta budu naznačeni točni volumeni.
Co-administration of chenodeoxycholic acid with ciclosporin or sirolimus should be avoided.
Treba izbjegavati istodobnu primjenu kenodeoksikolatne kiseline i ciklosporina ili sirolimusa.
Chenodeoxycholic acid Leadiant capsules treats CTX by replacing the chenodeoxycholic acid, which prevents the build-up of the fatty deposits.
Kapsule lijeka Chenodeoxycholic acid Leadiant liječe CTX tako što nadomještaju kenodeoksikolatnu kiselinu, što sprječava nakupljanje masnih naslaga.
The use of oral contraceptives is not recommended in patients taking chenodeoxycholic acid, see section 4.5 for further details.
Primjena oralnih kontraceptiva se ne preporučuje za bolesnice koje uzimaju kenodeoksikolatnu kiselinu, vidjeti dio 4.5 za dodatne informacije.
What you need to know before you take Chenodeoxycholic acid Leadiant Do not take Chenodeoxycholic acid Leadiant
Što morate znati prije nego počnete uzimati Chenodeoxycholic acid Leadiant Nemojte uzimati Chenodeoxycholic acid Leadiant
Reduced production of cholestanol: reduces serum cholestanol (action on HMG CoA reductase and CYP7A1).
2. Smanjeno stvaranje kolestanola: smanjuje serumski kolestanol (djelovanje na HMG CoA reduktazu i CYP7A1).
The total daily dose = 10 kg x 15 mg/kg = 150 mg
Ukupna dnevna doza = 10 kg x 15 mg/kg = 150 mg
Chenodeoxycholic acid should not be administered together with colestipol or antacid medicinal products containing aluminium hydroxide and/or smectite (aluminium oxide) since these preparations bind the active substance of chenodeoxycholic acid in the intestine and thus prevent its reabsorption and efficacy.
Kenodeoksikolatna kiselina ne smije se primjenjivati zajedno s kolestipolom ili antacidima koji sadrže aluminijev hidroksid i/ili smektit (aluminijev oksid) jer ti pripravci vežu djelatnu tvar kenodeoksikolatnu kiselinu u crijevima i tako sprječavaju njezinu reapsorpciju i djelotvornost.
The following medicines may affect the levels of Chenodeoxycholic acid Leadiant:
Sljedeći lijekovi mogu utjecati na razine lijeka Chenodeoxycholic acid Leadiant:
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.
Jedan slučaj nuspojave vezane uz jetru se dogodio kod dva tjedna starog dojenčeta kojem je dijagnosticiran CTX i opisan je u donjem odjeljku.
Chenodeoxycholic acid capsules can be taken without regards to food.
Kapsule s kenodeoksikolatnom kiselinom mogu se uzimati bez obzira na hranu.
(Weight in kg) x (Dose in mg/kg) = Daily dose in mg
(Težina u kg) x (doza u mg/kg) = dnevna doza u mg podijeljena doza* (Dnevna doza u mg) = Podijeljena doza u mg
What you need to know before you take Chenodeoxycholic acid Leadiant 3.
Što trebate znati prije nego počnete uzimati Chenodeoxycholic acid Leadiant 3.
A small portion of chenodeoxycholic acid is excreted with faeces.
Mali dio kenodeoksikolatne kiseline se izlučuje fecesom.
Pharmacotherapeutic group: Alimentary tract and metabolism - Bile therapy - Bile acid preparations, ATC code: A05AA01
- Lijekovi koji djeluju na žuč - Pripravci žučnih kiselina, ATK oznaka: A05AA01
Two pregnancies in mothers with CTX resulted in premature infants with evidence of intrauterine growth retardation also reported in the literature.
U literaturi su također zabilježene dvije trudnoće kod majki s CTX-om koje su rezultirale nedonoščadi s dokazima unutarmaterničnog zastoja rasta.
Chenodeoxycholic acid Leadiant 250 mg hard capsules
Chenodeoxycholic acid Leadiant 250 mg tvrde kapsule
It is not recommended to take oral contraceptives whilst taking Chenodeoxycholic acid Leadiant.
Nije preporučljivo uzimati oralnu kontracepciju dok uzimate lijek Chenodeoxycholic acid Leadiant.
The total daily dose = 3 kg x 5 mg/kg = 15 mg
Ukupna dnevna doza = 3 kg x 5 mg/kg = 15 mg
If you take more Chenodeoxycholic acid Leadiant than you should
Ako uzmete više lijeka Chenodeoxycholic acid Leadiant nego što ste trebali
The divided dose when given three times a day = 15 mg = 5 mg
Podijeljena doza kada se daje tri puta dnevno = 15 mg = 5 mg
Magnesium stearate Silica, colloidal anhydrous Water
Magnezijev stearat Silicijev dioksid, koloidni bezvodni Voda
Read the package leaflet before use.
Prije uporabe pročitajte uputu o lijeku Primjena kroz usta.
3 kg patient on a dose of 5 mg/kg of chenodeoxycholic acid.
bolesnik od 3 kg na dozi od 5 mg/kg kenodeoksikolatne kiseline.
10 kg patient on a dose of 15 mg/kg of chenodeoxycholic acid.
bolesnik od 10 kg na dozi od 15 mg/kg kenodeoksikolatne kiseline.
What Chenodeoxycholic acid Leadiant is and what it is used for 2.
Što je Chenodeoxycholic acid Leadiant i za što se koristi 2.
Co-administration with oral contraceptives is not recommended, see section 4.5 for further details.
Ne preporučuje se istodobna primjena s oralnim kontracepcijskim sredstvima, pogledajte dio 4.5 za dodatne informacije.
Chenodeoxycholic acid Leadiant capsules contain a substance called chenodeoxycholic acid.
Kapsule lijeka Chenodeoxycholic acid Leadiant sadrže tvar koja se zove kenodeoksikolatna kiselina.
The divided dose when given three times a day = 150 mg = 50 mg
Podijeljena doza kada se daje tri puta dnevno = 150 mg = 50mg
What Chenodeoxycholic acid Leadiant is and what it is used for
Što je Chenodeoxycholic acid Leadiant i za što se koristi
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 bebe, djecu i one koji ne mogu progutati kapsule i/ili trebaju primiti dozu manju od 250 mg, kapsula se može otvoriti i sadržaj pomiješati s 8,4%-tnom otopinom natrijevog bikarbonata.
Co-administration with oral contraceptives is not recommended.
Ne preporučuje se istodobna primjena s oralnim kontraceptivima.
even if their signs of illness are the same as yours.
Može im naškoditi, čak i ako su njihovi simptomi bolesti jednaki Vašima.
Constipation not known
Nuspojave vezane uz jetru nepoznato
Chenodeoxycholic acid should not be administered together with colestyramine as it binds chenodeoxycholic acid in the intestine and thus prevents its reabsorption and efficacy.
Kolestiramin Kenodeoksikolatna kiselina ne smije se primjenjivati zajedno s kolestiraminom jer veže kenodeoksikolatnu kiselinu u crijevima i tako sprječava njezinu reapsorpciju i djelotvornost.
Chenodeoxycholic acid Leadiant capsules can be used from the age of one month and patients with CTX will require treatment for the rest of their life.
Kapsule lijeka Chenodeoxycholic acid Leadiant mogu se koristiti od dobi od 1 mjeseca, a bolesnici s
Dose calculation (Infants 1month-1yr) chenodeoxycholic acid 5 mg/mL suspension Daily dose:
Izračunavanje doze (Dojenčad 1 mjesec-1 godina) suspenzija koja sadrži 5 mg/ml kenodeoksikolatne kiseline Dnevna doza:
Chenodeoxycholic acid Leadiant is provided as hard capsules.
Chenodeoxycholic acid Leadiant je u obliku tvrdih kapsula.
No data are available for patients with renal impairment.
Nema podataka o bolesnicima s oštećenjem bubrega.
It is not known if Chenodeoxycholic acid Leadiant passes into breast milk.
Nije poznato izlučuje li se lijek Chenodeoxycholic acid Leadiant u majčino mlijeko.
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.
Kako bi se prikupili podaci o dugoročnoj sigurnosti i djelotvornosti kod bolesnika liječenih kenodeoksikolatnom kiselinom, nositelj odobrenja će podnijeti rezultate ispitivanja dobivene iz registra bolesnika s urođenim greškama sinteze primarne žučne kiseline uzrokovanih nedostatkom sterol
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI I OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
- The active substance is chenodeoxycholic acid.
- Djelatna tvar je kenodeoksikolatna kiselina.
What Chenodeoxycholic acid Leadiant looks like and contents of the pack
Kako izgleda Chenodeoxycholic acid Leadiant i sadržaj pakiranja
Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid
Chenodeoxycholic acid Leadiant 250 mg tvrde kapsule kenodeoksikolatna kiselina
In the intestine Chenodeoxycholic acid and its glycine or taurine conjugate are decomposed by bacteria.
U crijevu bakterije razgrađuju kenodeoksikolatnu kiselinu i njen konjugat s glicinom ili taurinom.
If you have to take colestyramine then take Chenodeoxycholic acid Leadiant either one hour before colestyramine or 4-6 hours after.
Ako trebate uzimati kolestiramin, onda uzmite lijek Chenodeoxycholic acid Leadiant ili jedan sat prije ili 4-6 sati nakon uzimanja kolestiramina.
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.
Ako se smatra da je primjena ciklosporina ili sirolimusa nužna, treba pažljivo pratiti razine žučnih alkohola u serumu i urinu, te sukladno tome prilagoditi dozu kenodeoksikolatne kiseline.
If administration of phenobarbital is considered necessary, serum and urine bile alcohol levels should be closely monitored and the chenodeoxycholic acid dose adjusted accordingly.
Ako se smatra da je primjena fenobarbitala nužna, treba pažljivo pratiti razine žučnih alkohola u serumu i urinu, te sukladno tome prilagoditi dozu kenodeoksikolatne kiseline.
Hepatic adverse reactions not known
Poremećaji probavnog sustava Konstipacija nepoznato
If you forget to take Chenodeoxycholic acid Leadiant
Ako zaboravite uzeti Chenodeoxycholic acid Leadiant
Hepatic impairment
je inhibirana.
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 djecu, adolescente i odrasle koji ne mogu progutati kapsule i/ili trebaju uzeti dozu manju od 250 mg, kapsule se mogu otvoriti i sadržaj dodati u 25 ml 8,4%-tne (1 mmol/ml) otopine natrijevog bikarbonata kako bi se napravila suspenzija koja sadrži 10 mg/ml kenodeoksikolatne kiseline.
Other medicines and Chenodeoxycholic acid Leadiant
Drugi lijekovi i Chenodeoxycholic acid Leadiant
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 djecu, adolescente i odrasle koji ne mogu progutati kapsule i/ili trebaju uzeti dozu manju od 250 mg, kapsulu se može otvoriti, sadržaj dodati u 25 ml 8,4%-tne (1 mmol/ml) otopine natrijevog bikarbonata i pomiješati kako bi se napravila suspenzija koja sadrži 10 mg/ml kenodeoksikolatne kiseline.
The administration of oral contraceptives reduces the pool size of chenodeoxycholic acid.
Primjena oralnih kontraceptiva smanjuje količinu kenodeoksikolatne kiseline u tijelu.
Chenodeoxycholic acid should be taken either one hour before cholestyramine or 4-6 hours after.
Kenodeoksikolatnu kiselinu treba uzeti ili jedan sat prije ili 4-6 sati nakon uzimanja kolestiramina.
If you stop taking Chenodeoxycholic acid Leadiant
Ako prestanete uzimati Chenodeoxycholic acid Leadiant
Breast-feeding It is unknown whether chenodeoxycholic acid/metabolites are excreted in human milk.
Nije poznato izlučuje li se kenodeoksikolatna kiselina/metaboliti u majčino mlijeko.
If it is necessary to take colestyramine then chenodeoxycholic acid should be taken either one hour before colestyramine or 4-6 hours after.
Ako je potrebno uzeti kolestiramin, onda kenodeoksikolatnu kiselinu treba uzeti ili jedan sat prije ili 4-6 sati nakon uzimanja kolestiramina.
MedDRA System Organ Class Preferred term
MedDRA klasifikacija organskih sustava
There are no or limited amount of data from the use of chenodeoxycholic acid in pregnant women.
Podataka o uporabi kenodeoksikolatne kiseline kod trudnica nema ili su ograničeni.
How to store Chenodeoxycholic acid Leadiant 6.
Kako čuvati Chenodeoxycholic acid Leadiant 6.
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 dojenčad kapsule se mogu otvoriti i sadržaj dodati u 50 ml 8,4%-tne otopine natrijevog bikarbonata (1 mmol/ml) kako bi se napravila suspenzija koja sadrži 5 mg/ml kenodeoksikolatne kiseline.
Chenodeoxycholic acid given orally is absorbed in the small intestine.
Kenodeoksikolatna kiselina primijenjena peroralno apsorbira se u tankom crijevu.
For infants the capsules may be opened, the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Za dojenčad kapsule se mogu otvoriti i sadržaj dodati u 50 ml 8,4%-tne otopine natrijevog bikarbonata (1 mmol/ml) i pomiješati kako bi se napravila suspenzija koja sadrži 5 mg/ml kenodeoksikolatne kiseline.
Each hard capsule contains 250 mg of chenodeoxycholic acid.
Svaka tvrda kapsula sadrži 250 mg kenodeoksikolatne kiseline.
Elderly patients (≥ 65 years)
Posebne populacije Stariji bolesnici (≤ 65 godina) Nije potrebno prilagoditi dozu.
- Each capsule contains 250 mg of chenodeoxycholic acid.
- Svaka kapsula sadrži 250 mg kenodeoksikolatne kiseline.
Package leaflet: Information for the user Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za korisnika Chenodeoxycholic acid Leadiant 250 mg tvrde kapsule kenodeoksikolatna kiselina
Colestyramine
Doziranje
(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
Volumen za primjenu: (Podijeljena doza u mg) x 1 ml = Količina suspenzije koju treba dati
Each capsule contains 250 mg chenodeoxycholic acid.
Svaka kapsula sadrži 250 mg kenodeoksikolatne kiseline.
In patients with CTX, no interaction studies with chenodeoxycholic acid and concomitantly administered medicinal products have been performed.
Ispitivanja interakcija između kenodeoksikolatne kiseline i istodobno primijenjenih lijekova nisu provedena na bolesnicima koji imaju CTX.
(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
Volumen za primjenu: (Podijeljena doza u mg x 1 ml) = Količina suspenzije koju treba dati
How to take Chenodeoxycholic acid Leadiant
Kako uzimati Chenodeoxycholic acid Leadiant
Concomitant administration of chenodeoxycholic acid with phenobarbital increases HMG CoA reductase and thus counteracts one of the pharmacodynamics effects of chenodeoxycholic acid in CTX.
reduktaze i stoga poništava jedan od farmakodinamičkih učinaka kenodeoksikolatne kiseline u CTX-u.
How to store Chenodeoxycholic acid Leadiant
Kako čuvati Chenodeoxycholic acid Leadiant
Your doctor will advise you if for any reason you have to stop treatment with Chenodeoxycholic acid Leadiant.
Liječnik će Vam reći ako iz nekog razloga morate prestati liječenje lijekom
The following medicines may reduce the effect of Chenodeoxycholic acid Leadiant:
Sljedeći lijekovi mogu umanjiti učinak lijeka Chenodeoxycholic acid Leadiant: • kolestiramin, kolestipol (takozvani sekvestranti žučne kiseline)
This was confirmed within the framework of this article 30 procedure.
To je potvrđeno unutar okvira ovog postupka u skladu sa člankom 30.
The stability data at these testing conditions has shown that the results are within the acceptance criteria and the product is stable.
Podaci o stabilnosti u ovim testnim uvjetima pokazali su da se rezultati nalaze unutar kriterija prihvatljivosti te da je lijek stabilan.
Moreover, recent trials have confirmed the benefit of Sandimmun in different forms of nephrotic syndrome in children and adults.
Nadalje, posljednja su istraživanja potvrdila koristi lijeka Sandimmun u slučaju različitih oblika nefrotskog sindroma u djece i odraslih.
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 lijeka Sandimmun Neoral temeljila se na podacima o djelotvornosti i sigurnosti iz kliničkih ispitivanja provedenih s formulacijama na bazi ulja (Sandimmun), koje su po prvi put registrirane u Švicarskoj u prosincu 1982. godine.
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.
Nositelj odobrenja potvrdio je da su ispitivanja stabilnosti provedena u dugoročnim uvjetima pri 25°C/60% RV i također u ubrzanim uvjetima pri
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).
Ciklosporin se koristi, također, za niz stanja za koja je poznato da su, ili se mogu smatrati, autoimunog porijekla (endogeni uveitis, nefrotski sindrom, reumatoidni artritis, psoriaza i atopički dermatitis).
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).
„Dnevne doze lijeka Sandimmum moraju se uzimati uvijek u dvije podijeljene doze“, s obzirom da riječ „uvijek“ treba biti izostavljena (u određenim je slučajevima potrebno uzimati lijek tri puta na dan).
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).
Nositelj odobrenja potvrdio je da su mjere čuvanja navedene u sažetku opisa svojstava lijeka za Sandimmun mekane želatinaste kapsule i oralne otopine već usklađene sa zahtjevima navedenima u Smjernici za deklaraciju mjera pri čuvanju lijeka (CPMP/QWP/609/96/Rev 2, od 19. studenog 2007.).
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).
Sandimmun upotrijebljen je kao osnova za pregled s obzirom da je dosje, koji podržava odobrenje nove formulacije ciklosporina (Sandimmun Neoral), bio temeljen na farmakokinetičkoj evaluaciji koja je dokazala ekvivalenciju 2 oblika ciklosporina (formulacije na bazi ulja u odnosu na mikoemulgiranu formulaciju).
It is recommended that Sandimmun be administered on a consistent schedule with regard to time of day and relation to meals.
Preporuča se da se lijek Sandimmun uzima prema konzistentnom rasporedu s obzirom na doba dana i obroke.“
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.”
Lijekovi koji smanjuju razinu ciklosporina, Lijekovi koji povećavaju razinu ciklosporina, Druge značajne interakcije s lijekovima, Preporuke, Pedijatrijska populacija i Druge relevantne interakcije s lijekovima.“
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.
Stoga je nositelj odobrenja udovoljio izjavi o posebnim mjerama pri čuvanju lijeka i PL s obzirom da je formulacija „Ovaj lijek ne zahtjeva nikakve posebne uvjete pri čuvanju“ u skladu sa smjernicom.
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.
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 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.
Nadalje, nositelj odobrenja predložio je ispravak u formulaciji „Posebne mjere pri čuvanju lijeka“ u sažetku opisa svojstava lijeka za Sandimmun 50 mg/ml koncentrat za otopinu za infuziju, također u skladu s prethodno navedenom smjernicom.
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.
Nositelj odobrenja predložio je sljedeću formulaciju za ovu indikaciju: „Sandimmun indiciran je u bolesnika s teškim atopičkim dermatitisom kada je potrebna sistemna terapija.“