natgillin/translations-raw huggingface dataset:
Efficib combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Vsebuje sitagliptinijev fosfat, ki je zaviralec dipeptidil-peptidaze 4 (DPP-4), in metforminijev klorid, ki spada med bigvanide.
Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Efficib) or during post-approval use of Efficib or sitagliptin alone or with other diabetes medicines:
Pri nekaterih bolnikih, ki so v kliničnih študijah jemali samo sitagliptin (eno od učinkovin v zdravilu Efficib) ali so v obdobju trženja jemali zdravilo Efficib ali sitagliptin, sam ali z drugimi zdravili za zdravljenje sladkorne bolezni, so se pojavili naslednji neželeni učinki: Pogosti: nizek krvni sladkor, glavobol, okužba zgornjih dihal, zamašen nos ali izcedek iz nosu in vnetje grla, osteoartritis, bolečine v rokah ali nogah Občasni: omotica, zaprtje, srbenje
Overall summary of the scientific evaluation of Tibocina and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Tibocina in povezanih imen (glejte Prilogo I)
Such decisions should instead be taken on a case by case basis, following an evaluation of the findings and their potential impact.
Take odločitve je treba sprejemati na podlagi posameznih primerov po vrednotenju ugotovitev in njihovega morebitnega vpliva.
Tibolone is a synthetic steroid hormone drug which acts as an agonist, mainly on oestrogen receptors.
Tibolon je sintetično steroidno hormonsko zdravilo, ki deluje kot agonist, predvsem na estrogenske receptorje.
These findings were classified as critical and one of the concerned member states therefore considered it impossible to conclude on the reliability of the bioequivalence study.
Te ugotovitve so bile razvrščene kot kritične, zato je ena od zadevnih držav članic menila, da je nemogoče sklepati o zanesljivosti študije biološke enakovrednosti.
A referral under Article 29(4) of Directive 2001/83/EC was triggered and the CHMP was requested to give its opinion on whether the proposed products Tibolona Aristo and Tibocina can be considered bioequivalent to the reference product.
Skladno s členom 29(4) Direktive 2001/83/ES je bil sprožen napotitveni postopek, ki je od odbora CHMP zahteval, da poda mnenje o tem, ali se lahko zdravili Tibolona Aristo in Tibocina obravnavata kot biološko enakovredni referenčnemu zdravilu.
Having reviewed the available data, the CHMP considered that there was sufficient additional evidence indicating that the study samples were not put at risks during the study and that these were maintained under adequate temperature conditions.
Po pregledu razpoložljivih podatkov je odbor CHMP sklenil, da je dovolj dodatnih dokazov, ki kažejo, da preiskovani vzorci med študijo niso bili izpostavljeni tveganjem in da so bili shranjeni pri ustreznih temperaturnih pogojih.
The CHMP therefore reviewed the additional clinical evidence available, including the assessment carried out during the CMDh procedure and the evidence submitted by the Applicant.
Odbor CHMP je zato pregledal dodatne razpoložljive klinične dokaze, vključno z oceno, opravljeno med postopkom CMDh, in dokazi, ki jih je predložil predlagatelj.
Two applications under the decentralised procedure were submitted for the generic products Tibolona Aristo and Tibocina, both 2.5 mg tablets with the indication “treatment of oestrogen deficiency symptoms in women, more than one year after the menopause”.
Za generični zdravili Tibolona Aristo in Tibocina, 2,5 mg tablete, z indikacijo „zdravljenje simptomov pomanjkanja estrogena pri ženskah več kot leto po menopavzi“, sta bili predloženi dve vlogi v okviru decentraliziranega postopka.
In addition, the bioequivalence study conducted demonstrated bioequivalence, with observed drug concentrations being comparable or superior to those reported in the literature and the CHMP considered that these results suggest that no significant degree of drug degradation occurred.
Poleg tega je opravljena študija biološke enakovrednosti pokazala biološko enakovrednost, pri čemer so bile opažene koncentracije zdravila primerljive ali boljše od koncentracij, o katerih poroča literatura, zato je odbor CHMP menil, da ti rezultati niso pokazali pomembne stopnje degradacije zdravila.
• the CHMP reviewed the available data, including the Rapporteurs' assessment reports and the explanations submitted by the Applicant during the CMDh procedure
• odbor CHMP je pregledal razpoložljive podatke, vključno s poročili o oceni zdravila, ki so jih pripravili poročevalci, in razlagami, ki jih je med postopkom CMDh predložil predlagatelj;
During the assessment of the application dossiers, a Good Clinical Practice (GCP) inspection of the clinical site identified a lack of evidence documenting the transfer date and time and the identification of pharmacokinetic samples from the dry ice box used for flash freezing to the freezer used at this site until the samples were transferred to the bioanalytical site.
Med vrednotenjem dosjejev z vlogama je pregled dobre klinične prakse (DKP) v kliničnem centru pokazal pomanjkanje dokazov o identifikaciji farmakokinetičnih vzorcev in dokumentiranju datuma in časa njihovega prenosa iz škatle s suhim ledom, uporabljene za hitro zamrzovanje, v zamrzovalnik, uporabljen v tem centru, do prenosa vzorcev v bioanalitični center.
The CHMP acknowledged that the findings are considered as a critical deficiency, however it did not consider that GCP inspection findings classified as critical should automatically invalidate the results of a bioequivalence study.
Odbor CHMP je potrdil, da pri ugotovitvah obstajajo kritične pomanjkljivosti, vendar je menil, da ugotovitve pregleda DKP, razvrščene kot kritične, ne bi smele samodejno razveljaviti rezultatov študije biološke enakovrednosti.
A single bioequivalence study was conducted to support both applications.
Podprti sta bili samo z eno študijo biološke enakovrednosti.
The CHMP therefore concluded that while deviations from GCP requirements were identified, the totality of the available evidence confirms that the results of the bioequivalence study are reliable and demonstrates the bioequivalence of the proposed products and the reference product.
Odbor CHMP je zaključi, da so celotni razpoložljivi dokazi kljub odstopanju od zahtev DKP potrdili zanesljivost rezultatov študije biološke enakovrednosti in pokazali biološko enakovrednost zadevnih zdravil ter referenčnega zdravila.
Whereas
Nemčija
• the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibocina and associated names (see Annex I).
je odbor CHMP priporočil odobritev dovoljenj za promet z zdravili, za katera povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, kot je navedeno v Prilogi III za zdravilo Tibocina in povezana imena (glejte Prilogo I).
All symptoms resolved completely within a few hours.
Vsi simptomi so popolnoma izginili v nekaj urah.
• Allergic reactions which can, rarely, be serious
• alergijske reakcije, ki so lahko redko resne,
Women must be provided with comprehensive information on pregnancy prevention.
Ženskam je treba dati izčrpne informacije o preprečevanju nosečnosti.
Careful monitoring.
Skrbno spremljanje.
Response rates varied between 43 and 80% depending on the studies and the criteria to define a response.
Delež odziva je bil med 43 in 80 %, kar je bilo odvisno od študij in meril za opredelitev odziva.
Effects on human reproduction cannot be excluded.
Učinkov na razmnoževanje pri človeku ni mogoče izključiti.
Then go on with regular schedule as prescribed.
Potem nadaljujte z rednim razporedom, ki vam je bil predpisan.
In case of long term treatment (more than 6 months):
Pri dolgotrajnem zdravljenju (daljšem od 6 mesecev):
• Loss of appetite or increased appetite
• izguba apetita ali povečan apetit,
An ECG should be performed:
EKG je treba opraviti:
About 200 patients were treated for more than 6 months and some of them were treated for several years.
Približno 200 bolnikov so zdravili več kot 6 mesecev, nekatere izmed njih pa več let.
In a retrospective study conducted in several French centres, 200 patients with Cushing's disease were followed between 1995 and 2012.
V retrospektivni študiji, opravljeni v več francoskih ustanovah, so med letoma 1995 in 2012 spremljali 200 bolnikov s Cushingovo boleznijo.
Side effects with frequency not known (frequency cannot be estimated from the available data):
Neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
If you forget to take one dose, take this dose as soon as you remember.
Če ste pozabili vzeti en odmerek, ga vzemite takoj, ko se spomnite.
This can result in an increase and/or prolongation of their effects, including adverse reactions.
To lahko poveča in/ali podaljša njihove učinke, vključno z neželenimi učinki.
Do not change the prescribed dose yourself.
Predpisanega odmerka ne spreminjajte sami.
About 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged medicinal product.
Približno 13 % odmerka se izloči z urinom, od tega je od 2 do 4 % nespremenjenega zdravila.
Cmax and AUC increase more than proportionally with dose.
Vrednosti Cmax in AUC se več kot sorazmerno povečata z odmerkom.
Close surveillance will be necessary: blood pressure and fluid and electrolyte balance should be monitored for a few days.
Potrebno bo pozorno spremljanje: nekaj dni je treba spremljati krvni tlak ter ravnovesje tekočine in elektrolitov.
• Change in laboratory markers
• spremembe laboratorijskih označevalcev,
The requirements for submission of PSURsfor this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Careful monitoring of digoxin levels is recommended.
Priporočljivo je skrbno spremljanje ravni digoksina.
Aripiprazole dose should be reduced to approximatively one-half of its prescribed dose.
Odmerek aripiprazola je treba zmanjšati na približno polovico predpisanega odmerka.
Fatal cases have been reported particularly when treatment is continued despite liver enzyme elevation.
O smrtnih primerih so poročali predvsem, kadar se je zdravljenje nadaljevalo kljub povišanju ravni jetrnih encimov.
Treatment of juvenile rats for 30 day beginning at 21 days of age delayed the puberty onset.
Dajanje zdravila juvenilnim podganam, ki je trajalo 30 dni in se je začelo pri 21 dneh starosti, je upočasnilo nastop pubertete.
Frequency of hepatotoxicity could be higher in adolescents than in adults.
Pri mladostnikih je lahko pogostnost hepatotoksičnosti večja kot pri odraslih.
Serious hepatic toxicity caused by ketoconazole treatment is rare (1/15000).
Resna jetrna toksičnost, ki jo povzroča zdravljenje s ketokonazolom, je redka (1/15.000).
Tell your doctor or phamacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
In approximately 10 to 15 % of ketoconazole treated patients, an "escape phenomenon" is observed and reinforces the need for a long-term clinical and biochemical follow-up of these patients.
Pri približno 10 do 15 % bolnikov, zdravljenih s ketokonazolom, so opazili »pojav uhajanja«, kar nadalje podpira potrebo po dolgotrajnem kliničnem in biokemijskem spremljanju teh bolnikov.
This medicine is not recommended for children under 12 years due to the lack of data in these patients.
Otroci in mladostniki To zdravilo ni priporočljivo pri otrocih mlajših od 12 let, zaradi nezadostnih podatkov pri teh bolnikih.
Monitoring of the QTc interval
Spremljanje intervala QTc
Adrenal insufficiency is common and can be a serious side effect.
Adrenalna insuficienca je pogosta in je lahko resen neželeni učinek.
Associated with a decrease in corresponding values for the active metabolite
Povezano z zmanjšanjem ustrezajočih vrednosti za aktivni presnovek.
Use in Cushing's disease
Uporaba pri Cushingovi bolezni
There are no data suggesting a need for a specific dose adjustment in this population.
Podatkov, ki bi kazali na potrebo po posebnem prilagajanju odmerka v tej populaciji, ni.
Frequency groupings are defined according to 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:
Pogostnost je opredeljena na naslednji način: 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).
The adverse reactions listed below in table 2 are classified according to System Organ Class.
Spodaj navedeni neželeni učinki v preglednici 2 so razvrščeni glede na organske sisteme.
The maximal dose that was used for treatment of Cushing's syndrome is 1,600 mg/day.
Največji odmerek, ki se je uporabil za zdravljenje Cushingovega sindroma, je bil 1600 mg/dan.
Hepatotoxicity does not appear to be dose dependent.
Hepatotoksičnost kot kaže ni odvisna od odmerka.
The dose will be adapted to your condition with the aim to restore normal cortisol levels.
Odmerek bo prilagodil vašemu stanju, pri čemer bo cilj ponovna vzpostavitev normalnih ravni kortizola.
Bone fragility and broken legs were reported in rats but were not observed in other species.
Pri podganah so poročali o krhkih kosteh in zlomljenih okončinah, vendar tega niso opazili pri drugih živalskih vrstah.
Careful monitoring as it may cause an earlier onset and/or an increased severity of side-effects.
Skrbno spremljanje, saj lahko povzroči zgodnji pojav in/ali povečano resnost neželenih učinkov.
Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Courron d‘Auvergne France
Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Courron d‘Auvergne
In vitro, the plasma protein binding is about 99% mainly to the albumin fraction.
Vezava na beljakovine v plazmi in vitro je približno 99-odstotna, predvsem na albuminsko frakcijo.
Initiation and follow up of the treatment must be supervised by specialists in endocrinology.
Uvedbo in spremljanje zdravljenja mora nadzorovati specialist endokrinolog.
- Prior to the start of ketoconazole - Within one week after the beginning of the treatment - As clinically indicated thereafter.
- pred začetkom uporabe ketokonazola; - v roku enega tedna po začetku zdravljenja; - potem pa kot je klinično indicirano.
Plasma elimination is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter.
Izločanje iz plazme je dvofazno, pri čemer je razpolovni čas v prvih 10 urah 2 uri, potem pa 8 ur.
Data on the use of ketoconazole in patients older than 65 years are limited, but there is no evidence to suggest that specific dose adjustment is required in these patients (see section 5.2).
Podatki o uporabi ketokonazola pri bolnikih, starejših od 65 let, so omejeni, vendar ni dokazov, da bi bilo treba pri teh bolnikih odmerek prilagajati (glejte poglavje 5.2).
If such a phenomenon occurs, a further dose increase may be required to maintain cortisol levels within the normal range.
Če pride do tega pojava, bo morda potrebno dodatno povečanje odmerka, da se bodo ravni kortizola vzdrževale znotraj normalnih vrednosti.
Ketoconazole was stopped, but she deteriorated rapidly and died.
Uporabo ketokonazola so prekinili, vendar se je njeno stanje hitro slabšalo in je umrla.
Table 2: Incidence of adverse reactions and marked laboratory abnormalities reported in the literature in adults and adolescents patients
Preglednica 2: Incidenca neželenih učinkov in pomembnih laboratorijskih abnormalnosti, o katerih so pri odraslih in mladostnikih poročali v literaturi
The efficacy and safety of ketoconazole in the treatment of Cushing's syndrome from all causes have been described through several published retrospective studies, chart reviews and case reports.
Učinkovitost in varnost ketokonazola pri zdravljenju Cushingovega sindroma zaradi vseh vzrokov so opisali v več objavljenih retrospektivnih študijah, pregledih zdravniških kartotek in poročilih o primerih.
The safety and efficacy of Ketoconazole HRA in children aged less than 12 years have not been established.
Varnost in učinkovitost zdravila Ketokonazol HRA pri otrocih, mlajših od 12 let, nista bili dokazani.
Studies in animals have shown effects on male and female reproductive parameters (see section 5.3).
Študije na živalih so pokazale učinke na moške in ženske parametre razmnoževanja (glejte poglavje 5.3).
Interactions between ketoconazole and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, an no change as “↔”).
Interakcije med ketokonazolom in drugimi zdravili so navedene v spodnji preglednici (povečanje je označeno kot »↑«, zmanjšanje kot »↓«, odsotnost spremembe pa kot »↔«).
Liver enzyme levels returned to normal within 2-12 weeks after a dose decrease or withdrawal of ketoconazole.
Ravni jetrnih encimov so se vrnile na normalne v 2 do 12 tednih po zmanjšanju odmerka ali prekinitvi zdravljenja s ketokonazolom.
Block and replace regimen
Režim zaviranja in nadomeščanja
Inhibition of these different transporters at clinically relevant concentrations of ketoconazole cannot be excluded.
Zaviranje teh različnih prenašalcev v klinično pomembnih koncentracijah ketokonazola ni mogoče izključiti.
Improvement of clinical symptoms was noted in most patients after initiation of treatment.
Po uvedbi zdravljenja so izboljšanje kliničnih simptomov opazili pri večini bolnikov.
Do not take Ketoconazole HRA if any of the above applies to you.
Ne jemljite zdravila Ketokonazol HRA, če kar koli od zgoraj navedenega velja za vas.
Activated charcoal may be given if considered appropriate.
Uporabi se lahko medicinsko oglje, če je primerno.
Although hepatotoxicity is usually observed at treatment initiation and within the first six months of treatment, monitoring of liver enzymes should be done under medical criteria.
Čeprav so hepatotoksičnost navadno opazili na začetku zdravljenja in v prvih šestih mesecih zdravljenja, je treba spremljanje jetrnih encimov opravljati skladno z zdravstvenimi merili.
Clinical improvement in hypokalaemia, metabolic alkalosis, diabetes mellitus, and hypertension occurred even in the absence of complete hormonal response.
Do kliničnega izboljšanja hipokaliemije, metabolične alkaloze, sladkorne bolezni in hipertenzije je prišlo tudi ob odsotnosti popolnega hormonskega odziva.
The major route of excretion is through the bile into the intestinal tract.
Glavna pot izločanja je skozi žolč v črevesje.
However, the genotoxic potential was not properly determined for the proposed dosing regimen in the treatment of endogenous Cushing's syndrome.
Vendar genotoksičnega potenciala za predlagan režim odmerjanja pri zdravljenju endogenega Cushingovega sindroma niso ustrezno določili.
Sunitinib Dasatinib Lapatinib Nilotinib Erlotinib Dabrafenib Cabozantinib
Dasatinib Lapatinib Nilotinib Erlotinib Dabrafenib Kabozantinib
At doses > 400 mg/day, half-lives of 3 to 10 hours have been reported.
Pri odmerkih > 400 mg/dan so poročali o razpolovnem času od 3 do 10 ur.
Based on limited data, pharmacokinetics parameters (AUC, Cmax and half-life) of ketoconazole for doses of 5 to 10 mg/kg/days, corresponding approximately to daily doses of 200-800 mg, are similar in paediatric and adult population.
Na podlagi omejenih podatkov so farmakokinetični parametri (AUC, Cmax in razpolovni čas) ketokonazola za odmerke od 5 do 10 mg/kg/dan, kar ustreza približnim dnevnim odmerkom 200-800 mg, podobni pri pediatrični in odrasli populaciji.
Potential interaction with medicinal products
Morebitno medsebojno delovanje z zdravili
Treatment should be initiated and supervised by physicians experienced in endocrinology or internal medicine and having the appropriate facilities for monitoring of biochemical responses since the dose must be adjusted to meet the patient's therapeutic need, based on the normalisation of cortisol levels.
Zdravljenje morajo uvesti in nadzorovati zdravniki z izkušnjami z endokrinologijo ali interno medicino, ki imajo na voljo ustrezno opremo za spremljanje biokemičnih odzivov, saj je treba odmerek prilagoditi glede na bolnikovo terapevtsko potrebo, ki temelji na normalizaciji ravni kortizola.
After ketoconazole withdrawal, liver enzymes returned to normal levels within 3 weeks (section 5.1).
Po prekinitvi ketokonazola so se ravni jetrnih encimov v 3 tednih vrnile na normalne (poglavje 5.1).
Use in ectopic Adrenocorticotropic Hormone (ACTH) syndrome
Uporaba pri sindromu ektopične sekrecije adrenokortikotropnega hormona (ACTH)
Use of ketoconazole with potent enzyme inducers is not recommended.
Uporaba ketokonazola z močnimi induktorji encimov ni priporočljiva.
Ketoconazole has been used both as sole medical therapy and in combination with other medicinal products, mainly with metyrapone, in patients with more severe disease or in those not completely responding to a single active substance or in those requiring a dose reduction of at least one of the medicinal products to improve tolerance.
Ketokonazol se je uporabil kot monoterapija in v kombinaciji z drugimi zdravili, večinoma metiraponom, pri bolnikih s hujšo boleznijo ali bolnikih, ki se niso popolnoma odzivali na eno učinkovino ali ki so potrebovali zmanjšanje odmerka vsaj enega od zdravil zaradi izboljšanja tolerance.
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Dose reduction of indinavir to 600 mg every 8 hours should be considered.
Skrbno spremljanje.Razmisliti je treba o zmanjšanju odmerka indinavirja na 600 mg vsakih 8 ur.
Indinavir (600mg TID): AUC= 0.8-fold
Indinavir (600 mg trikrat na dan): AUC=0,8-krat
In the event of accidental overdose, treatment consists of supportive measures.
Zdravljenje nenamernega prevelikega odmerjanja vključuje podporne ukrepe.
The safety of ketoconazole has been evaluated based on published literature and use of ketoconazole as an antifungal treatment.
Varnost ketokonazola so ocenili na podlagi objavljene literature in uporabe ketokonazola kot antimikotika.
In vitro data indicate that ketoconazole is a potent inhibitor of OATP1B1, OATP1B3, OAT3, OCT1 and OCT2 and to a lesser extent of OAT1 and BSEP.
In vitro podatki kažejo, da je ketokonazol močan zaviralec prenašalcev OATP1B1, OATP1B3, OAT3, OCT1 in OCT2, v manjši meri pa zavira tudi OAT1 in BSEP.
Increases in liver enzymes (≤ 5N and > 5N) were observed in ~13.5 % and ~2.5% of patients respectively occurring mostly within the first 6 months of treatment.
Povišanje ravni jetrnih encimov (≤ 5N in > 5N), ki se je večinoma pojavilo v prvih 6 mesecih zdravljenja, so opazili pri ~13,5 % oziroma ~2,5 % bolnikov.
The degrees of interaction mentioned below are not absolute values and may be dependent on the ketoconazole dose given, i.e. many results are reported following a ketoconazole dose of 200 mg and a stronger interaction may be expected at a higher dose and/or shorter dosing interval.
Stopnje spodaj navedenih interakcij niso absolutne vrednosti in so lahko odvisne od odmerka ketokonazola, tj. o mnogih rezultatih so poročali po odmerku ketokonazola 200 mg, zato se lahko pri večjem odmerku in/ali krajšem presledku odmerjanja pričakuje močnejša interakcija.