natgillin/translations-raw huggingface dataset:
Inductos is available as a kit for implant containing a powder, solvent and absorbable collagen sponge (or matrix).
Zdravilo Inductos je na voljo kot komplet za vsaditev, ki vsebuje prašek, vehikel in absorpcijsko kolagensko gobo (ali matriks).
Inductos will remain suspended until issues with the manufacturing site for one of the components of Inductos (an absorbable sponge) are resolved.
Umik dovoljenja za promet z zdravilom Inductos bo veljal, dokler se ne odpravijo težave, povezane z obratom, v katerem se proizvaja eden od sestavnih delov zdravila Inductos (absopcijska goba).
See sections 4.3, 4.4 and 5.2
Glejte poglavja 4.3, 4.4 in 5.2.
Older people
Starejši ljudje
If you are less than 18 years of age, the use of RILUTEK is not recommended because there is no information available in this population.
Če ste mlajši od 18 let, uporaba zdravila RILUTEK ni priporočljiva , saj ni na voljo nobenih informacij za to populacijo.
date of first authorisation: 10 June 1996 date of last renewal: 10 June 2006
Datum zadnjega podaljšanja: 10. junij 2006
Undesirable effects ranked under headings of frequency are listed below, using the following convention: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Spodaj našteti neželeni učinki so razvrščeni po pogostosti, po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Based on pharmacokinetic data, there are no special instructions for the use of RILUTEK in this population.
Na temelju farmakokinetičnih podatkov ni posebnih navodil za uporabo zdravila RILUTEK v tej populaciji.
Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02.
Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX02.
Each package contains 56 tablets.
Eno pakiranje vsebuje 56 tablet.
Therefore, RILUTEK should not be used in patients with any other form of motor neurone disease.
Zato se zdravila RILUTEK ne sme uporabljati pri bolnikih z drugimi oblikami bolezni motoričnega nevrona.
If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK.
Če mislite, da ste noseči, ali če nameravate dojiti, se posvetujte s svojim zdravnikom preden vzamete zdravilo RILUTEK.
What you need to know before you take RILUTEK
Kaj morate vedeti, preden boste vzeli zdravilo RILUTEK
Sanofi Mature IP 54 rue La Boétie 75008 Paris France
Sanofi Mature IP 54 rue La Boétie 75008 Paris Francija
Tell your doctor immediately if you experience any fever (increase in temperature) because RILUTEK may cause a decrease in the number of white blood cells.
Nemudoma obvestite svojega zdravnika, - če imate vročino (zvišanje telesne temperature), saj zdravilo RILUTEK lahko povzroči znižanje števila belih krvnih celic.
Safety and efficacy of RILUTEK has only been studied in ALS.
Varnost in učinkovitost zdravila RILUTEK sta bili raziskani le pri ALS.
Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/kg/day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Študije plodnosti pri podganah so pokazale rahlo poslabšanje reproduktivne sposobnosti in plodnosti pri odmerkih 15 mg/kg/dan (kar je več od terapevtskega odmerka), verjetno zaradi sedacije in letargije.
If you forget to take RILUTEK
Če ste pozabili vzeti zdravilo RILUTEK
RILUTEK stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Zdravilo RILUTEK prepreči sproščanje glutamata, kar najbrž pomaga preprečevati poškodbo živčnih celic.
Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued.
Zvišanje alanin aminotransferaze se je ponavadi pojavilo v 3 mesecih po začetku zdravljenja z riluzolom; ponavadi je bilo prehodno in raven se je med nadaljevanjem zdravljenja znižala na manj kot 2 kratno ULN po 2 do 6 mesecih.
What RILUTEK is and what it is used for
Kaj je zdravilo RILUTEK in za kaj ga uporabljamo
Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
Vsaka tableta vsebuje 50 mg riluzola in ima na eni strani vrezan napis "RPR 202".
If you take more RILUTEK than you should
Če ste vzeli večji odmerek zdravila RILUTEK, kot bi smeli
Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1).
Klinična preskušanja so pokazala, da zdravilo RILUTEK podaljša preživetje bolnikov z ALS (glejte poglavje 5.1).
There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Ni dokazov, da bi zdravilo RILUTEK terapevtsko učinkovalo na motorično funkcijo, pljučno funkcijo, fascikulacije, mišično moč ali motorične simptome.
The tablets should be taken by mouth, every 12 hours, at the same time of the day each day (e.g. in the morning and evening).
Priporočeni odmerek je ena tableta, dvakrat na dan. Tablete morate zaužiti, na 12 ur, vsak dan ob istem dnevnem času (npr. zjutraj in zvečer).
Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels.
Previdnost je potrebna pri predpisovanju riluzola bolnikom z anamnezo motenega delovanja jeter ali bolnikom z nekoliko zvišano ravnjo serumskih transaminaz (ALT/SGPT, AST/SGOT do vrednosti, ki je enaka 3-kratni zgornji meji normalne vrednosti (ULN)), bilirubina in/ali gama-glutamiltransferaze (GGT).
Treatment with RILUTEK should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
Zdravljenje z zdravilom RILUTEK sme uvesti samo zdravnik specialist z izkušnjami v zdravljenju bolezni motoričnega nevrona.
RILUTEK has not been shown to be effective in the late stages of ALS.
Ni dokazov, da bi zdravilo RILUTEK bilo učinkovito v poznih stadijih ALS.
In patients treated with riluzole 100 mg/day, survival was significantly higher compared to patients who received placebo.
Pri bolnikih, zdravljenih z riluzolom 100 mg/dan, je bilo preživetje značilno večje kot pri bolnikih, ki so dobivali placebo.
EU/1/96/010/001
ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/96/010/001
RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Zdravilo RILUTEK je indicirano za podaljšanje življenja ali časa do mehanične ventilacije pri bolnikih z amiotrofično lateralno sklerozo (ALS).
Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
INFORMATION IN BRAILLE
PODATKI V BRAILLOVI PISAVI RILUTEK
The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Primarna presnovna pot riluzola je uvodna oksidacija s citokromom P450 1A2, s čimer nastane Nhidroksiriluzol (RPR112512), glavni aktivni presnovek riluzola.
The pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment at 50 mg riluzole bid) are not affected in the older people (>70 years).
Farmakokinetični parametri riluzola se po večkratnem odmerjanju (4,5 dni zdravljenja s 50 mg riluzola dvakrat na dan) pri starejših ljudeh (> 70 let) ne spremenijo.
What RILUTEK looks like and content of the pack
Izgled zdravila RILUTEK in vsebina pakiranja
The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Tablete imajo kapsulam podobno obliko, so bele barve in imajo na eni strani vrezan napis "RPR 202".
RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
Zdravilo RILUTEK uporabljamo pri bolnikih z amiotrofično lateralno sklerozo (ALS).
RILUTEK is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Zdravila RILUTEK ni priporočljivo uporabljati pri bolnikih z okvarjenim delovanjem ledvic, ker v tej populaciji ni bilo študij s ponavljajočimi odmerki (glejte poglavje 4.4).
What RILUTEK is and what it is used for What you need to know before you take RILUTEK How to take RILUTEK
Kaj je zdravilo RILUTEK in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo RILUTEK Kako jemati zdravilo RILUTEK Možni neželeni učinki
In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section
Pri bolnikih (n=20), sodelujočih v kliničnih študijah, z zvišano ALT več kot 5 kratno ULN je bilo zdravljenje prekinjeno in v večini primerov so se koncentracije znižale na manj kot 2 kratno ULN v 2 do 4 mesecih.
Other medicines and RILUTEK Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Common side effects (may affect up to 1 in 10 people) of RILUTEK are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) zdravila RILUTEK so: omotica odrevenelost ali mravljinčavost ust bruhanje zaspanost pospešen srčni utrip driska glavobol bolečine v trebuhu bolečine
Do not take RILUTEK if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases), if you are pregnant or breast-feeding.
Ne jemljite zdravila RILUTEK - če ste alergični na riluzol ali katero koli sestavino tega zdravila(navedeno v poglavju 6), - če imate katero od bolezni jeter ali zvišanje krvnih koncentracij določenih jetrnih encimov
Manufacturer Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Izdelovalec Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, 60205 Compiègne, Francija
Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, 60205 Compiègne, Francija.
You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast-feeding.
Nosečnost, dojenje in plodnost Zdravila RILUTEK NE SMETE jemati, če ste noseči ali mislite, da ste noseči ali če dojite.
RILUTEK is contraindicated in pregnancy (see sections 4.3 and 5.3).
Zdravilo RILUTEK je kontraindicirano med nosečnostjo (glejte poglavji 4.3 in 5.3).
The active substance in RILUTEK is riluzole which acts on the nervous system.
Zdravilna učinkovina v zdravilu RILUTEK je riluzol, ki deluje na živčevje.
Very common side effects (may affect more than 1 in 10 people) of RILUTEK are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) zdravila RILUTEK so: - utrujenost - slabost - zvišanje koncentracij določenih jetrnih encimov (transaminaz) v krvi.
How to take RILUTEK
Kako jemati zdravilo RILUTEK
NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi Mature IP
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Mature IP
In vitro studies using human liver preparations demonstrated that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole.
Študije preparatov človeških jeter in vitro so pokazale, da je P450 1A2 glavni izoencim, ki sodeluje v presnovi riluzola.
RILUTEK is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Zdravilo RILUTEK je kontraindicirano pri ženskah, ki dojijo (glejte poglavji 4.3 in 5.3).
RILUTEK 50 mg film-coated tablets Riluzole
RILUTEK 50 mg filmsko obložene tablete riluzol
Marketing Authorisation Holder Sanofi Mature IP
Imetnik dovoljenja za promet z zdravilom Sanofi Mature IP
RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti riluzola, pri katerikoli nevrodegenerativni bolezni otrok in mladostnikov, uporaba zdravila RILUTEK pri pediatrični populaciji ni priporočljiva.
Core:
Serija:
if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
- če se vam pojavi kateri od sledečih simptomov: porumenelost vaše kože ali beločnice vaših oči (zlatenica), srbenje po celem telesu, občutek slabosti, slabost, saj so to lahko znaki bolezni jeter (hepatitis).
Liver impairment
Ledvična okvara
Diarrhoea, abdominal pain, vomiting
Bolezni prebavil navzeja diareja, bolečine v trebuhu, bruhanje pankreatitis
RILUTEK is available in a pack of 56 tablets to be taken orally.
Zdravilo RILUTEK je na voljo v pakiranjih s 56 tabletami in ga jemljemo z zaužitjem.
Severe neutropenia (see section 4.4)
(glejte poglavje 4.4)
Warnings and precautions Talk to your doctor before taking RILUTEK: if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick if your kidneys are not working very well if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.
(zlatenica), srbenje po celem telesu, občutek slabosti, slabost - če vam ledvice ne delujejo dobro - če imate vročino: pojavi se lahko zaradi znižanega števila belih krvnih celic, kar lahko poveča tveganje za okužbo
NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets
IME ZDRAVILA RILUTEK 50 mg filmsko obložene tablete
You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Vpliv na sposobnost upravljanja vozil in strojev Če po jemanju zdravila RILUTEK niste omotični ali vrtoglavi, lahko vozite ali upravljate s kakršnimikoli orodji ali stroji.
Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Jedro: brezvodni kalcijev hidrogenfosfat mikrokristalna celuloza brezvodni koloidni silicijev dioksid magnezijev stearat premreženi natrijev karmelozat
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 10. junij 1996
What RILUTEK contains
Kaj vsebuje zdravilo RILUTEK
What RILUTEK is
Kaj je zdravilo RILUTEK
Renal impairment Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Pri bolnikih z okvarjenim delovanjem ledvic študije s ponavljajočimi odmerki niso bile izvedene (glejte poglavje 4.2).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of riluzole For the full list of excipients, see section 6.1.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 50 mg riluzola.
What RILUTEK is used for
Za kaj uporabljamo zdravilo RILUTEK
How to store RILUTEK
Shranjevanje zdravila RILUTEK
Titanium dioxide (E171)
Obloga: hipromeloza makrogol 6000 titanov dioksid (E 171)
Tel: +44 (0) 845 372 7101
United Kingdom sanofi-aventis Tel: +44 (0) 845 372 7101
Abnormal liver function tests
Bolezni jeter, žolčnika in žolčevodov nenormalni testi jetrnih funkcij hepatitis
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/010/001
The expiry date refers to the last day of that month.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Upor.
RE-EXAMINATION OF THE CHMP OPINION ADOPTED ON 23 APRIL 2009
PONOVNA PRESOJA MNENJA CHMP Z DNE 23. APRILA 2009
-The safety profile of ciclosporin is also critical.
- Varnostni profil ciklosporina je tudi kritičen.
In clinical routine practice therapeutic drug monitoring is done in order to control for and monitor safety.
V klinični rutinski praksi se izvaja terapevtsko spremljanje zdravil, da se nadzira in spremlja varnost zdravila.
Benefit/risk assessment
Ocena koristi in tveganj
4) The fourth issue raised by CHMP was about the food effect on ciclosporin.
4) Četrto vprašanje CHMP je bilo o učinku hrane na ciklosporin.
Summary of Grounds for Re-Examination
Povzetek podlage za ponovno presojo
In the MRP procedure (NL/H/1402/001-003/MR) potential serious risk for public health concern was raised on the following grounds: bioequivalence has not been sufficiently demonstrated.
V postopku z medsebojnim priznavanjem (NL/H/1402/001-003/MR) se je pojavil zadržek zaradi možnega resnega tveganja za javno zdravje zaradi sledečega vzroka: biološka enakovrednost ni bila zadostno dokazana.
ANNEX III CONDITION FOR THE LIFTING OF THE MARKETING AUTHORISATIONS SUSPENSION
DODATEK III POGOJI ZA PREKLIC ZADRŽANJA DOVOLJENJ ZA PROMET Z ZDRAVILOM
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
In addition, in the Transplant Patient Guide (University of Southern California-Cardiothoracic Surgery and Pancreas Transplant Program), it is recommended to take ciclosporin before meals, for better absorption by the stomach.
Poleg tega se v dokumentu Priročnik za bolnike o presaditvah (Transplant Patient Guide) (Univerza Južne Kalifornije - Program za kardiotorakalni kirurški poseg in presaditev trebušne slinavke (University of Southern California - Cardiothoracic Surgery and Pancreas Transplant Program)) priporoča, da se ciklosporin jemlje pred obroki zaradi boljše absorpcije v želodcu.
The Reference medicinal product authorised in Germany is: Sandimmun Optoral 25 mg Kapseln.
Referenčno zdravilo, odobreno v Nemčiji, je: Sandimmun Optoral 25 mg Kapseln.
2) The second question raised by CHMP was whether the same acceptance range (either normal or narrowed) should be applied both for AUC and Cmax.
2) Drugo vprašanje CHMP je bilo, ali je treba za vrednosti AUC in Cmax uporabiti enak razpon sprejemljivosti (bodisi običajni bodisi ožji).
Ciclosporin is indicated in transplantation (e.g. prevention or treatment of rejection of solid organ transplantation, bone marrow transplantation, graft-versus-host-disease) and auto-immune diseases (e.g nephrotic syndrome, rheumatoid arthritis, psoriasis, atopic dermatitis).
Ciklosporin je indiciran pri presaditvah (npr. preprečevanje ali zdravljenje zavrnitve presaditve trdnega organa, presaditve kostnega mozga, bolezni presadka proti gostitelju) ter avtoimunskih boleznih (npr. nefrotski sindrom, revmatski artritis, psoriaza, atopični dermatitis).
Strength Pharmaceutical Form
Farmacevtska oblika Pot uporabe zdravila
The number of adverse events may be associated with the huge variation in blood concentrations of the reference drug that will follow if it is taken regardless of food intake and the lack of instructions given regarding food intake.
Število neželenih dogodkov je lahko povezano z veliko variacijo koncentracij referenčnega zdravila v krvi, ki bo sledila vnosu zdravila ne glede na vnos hrane in odsotnost navodila o vnosu hrane.
This narrow range should apply to both AUC and Cmax as outside range values for any of both parameters can lead to efficacy and/or safety unwanted consequences.
Ožji razpon mora veljati za vrednosti AUC in Cmax, saj lahko vrednosti izven razponov obeh parametrov povzročijo neželene posledice v zvezi z učinkovitostjo ali varnostjo ali obojim.
The Efficacy Working Party PK expert group, consulted by the CHMP, understood that in clinical practice, ciclosporin is often recommended to be taken in a standardised way in relation to food.
Strokovna skupina za farmakokinetiko pri delovni skupini za učinkovitost, s katero se je posvetoval CHMP, je razumela, da se v klinični praksi pogosto priporoča standardizirano jemanje ciklosporina glede na hrano.
This may result in major swings in blood concentrations, since it has been shown that the intake of food has a very negative effect on absorption (up to about 30% reduction of Cmax and 15% reduction in AUC) of the reference product.
To lahko povzroči bistvena nihanja koncentracij v krvi, ker je bilo dokazano, da ima vnos hrane zelo negativen učinek na absorpcijo (do približno 30-odstotno zmanjšanje vrednosti Cmax in 15-odstotno zmanjšanje vrednosti AUC) referenčnega zdravila.
The CHMP addressed a list of questions to the Marketing Authorisation Holder and to the Efficacy Working Party PK expert group for consultation on the following points:
CHMP je posredoval seznam vprašanj imetniku dovoljenja za promet z zdravilom in strokovni skupini za farmakokinetiko pri delovni skupini za učinkovitost zaradi posvetovanja o naslednjih točkah:
There is emerging data indeed to suggest that appropriate therapeutic monitoring may radically reduce the incidence of acute rejection in de-novo recipients and ameliorate chronic rejection and secondary effects in maintenance transplant patients, as for ciclosporin, the patients inter and intra-variability is actually more problematic than the therapeutic index.
Objavljeni bodo podatki, ki kažejo, da lahko ustrezno terapevtsko spremljanje korenito zmanjša pojavnost akutne zavrnitve pri prejemnikih de novo ter izboljša kronično zavračanje in sekundarne učinke pri vzdrževanju bolnikov po presaditvi, saj je pri ciklosporinu variabilnost med bolniki in v okviru bolnika dejansko težavnejša od terapevtskega indeksa.
Differences in Cmax were considered less important, because a peak level is maintained for only a short period of time, whereas AUC represents the total exposure to the drug, but it was felt that the conventional range should be used.
Razlike v vrednosti Cmax so se štele za manj pomembne, ker najvišja koncentracija traja zelo kratek čas, vrednost AUC pa predstavlja celotno izpostavljenost zdravilu, vendar je predlagatelj menil, da je treba uporabiti običajni razpon.
The MAH stated that this issue needs to be addressed by the Regulatory Authorities and should be taken into consideration when evaluating IDL test product formulation, because this could play a definite role for safety issues, knowing that efficacy was preserved in any case as shown by the AUCs results.
Imetnik dovoljenja za promet z zdravilom je navedel, da morajo regulativni organi to zadevo obravnavati in upoštevati pri presoji preskušanega zdravila izdelovalca IDL, ker lahko odločilno vpliva na varnostna vprašanja ob upoštevanju, da je učinkovitost v vsakem primeru ohranjena, kar dokazujejo rezultati vrednosti AUC.
The issue here is clearly not a problem of interchangeability between Sandimmune and its optimized formulation of Neoral, but a lack of proof of bioequivalence, since this is a generic procedure.
Ne gre za težavo izmenljivosti zdravila Sandimmune in optimizirane formulacije zdravila Neoral, ampak nedokazane biološke enakovrednosti, ker gre za generični postopek.
3) The third point raised by CHMP was whether the same set of requirements should be applied for assessing bioequivalence under high-fat fed conditions.
3) Tretje vprašanje CHMP je bilo, ali je treba uporabiti enak nabor zahtev za vrednotenje biološke enakovrednosti pri preiskovancih s prehrano z veliko vsebnostjo maščob.