FrancophonIA/ELRC3.0 huggingface dataset:
English: Withdrawal of the marketing authorisation application for IXinity (trenonacog alfa) EMA/379048/2013
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom IXinity (trenonakog alfa) EMA/442989/2013
English: Patients with haemophilia B do not have sufficient levels of factor IX, a protein in the blood that helps it to clot normally.
Slovenian: Bolniki s hemofilijo B nimajo zadostnih količin faktorja IX, tj. beljakovine v krvi, ki pomaga pri normalnem strjevanju krvi.
English: The active substance in IXinity, trenonacog alfa, is a form of human factor IX that replaces the missing factor IX in the blood, temporarily controlling the bleeding disorder.
Slovenian: Zdravilna učinkovina v zdravilu IXinity, trenonakog alfa, je oblika humanega faktorja IX, ki nadomesti manjkajoči faktor IX v krvi, s čimer omogoča začasno obvladovanje motnje strjevanja krvi.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision to withdraw the application was based on the fact that the additional data required to address the CHMP's concerns could not be made available within the regulatory timeframe.
Slovenian: Družba je v uradnem dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik odločila na podlagi dejstva, da v zakonsko predpisanem roku ne more zagotoviti dodatnih podatkov, s katerimi bi lahko odgovorila na zadržke odbora CHMP.
English: The active substance in IXinity is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce the clotting factor.
Slovenian: Zdravilna učinkovina zdravila IXinity se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri je v celice vstavljen gen (DNK), s pomočjo katerega lahko tvorijo faktor strjevanja krvi.
English: What was IXinity expected to be used for?
Slovenian: Za kaj naj bi se zdravilo IXinity uporabljalo?
English: How is IXinity expected to work?
Slovenian: Kako naj bi zdravilo IXinity delovalo?
English: There are no special requirements for disposal.
Slovenian: Ni posebnih zahtev za odstranjevanje.
English: Date of first authorisation: 20 September 2007 Date of latest renewal: 28 August 2017
Slovenian: Datum prve odobritve: 20. september 2007 Datum zadnjega podaljšanja: 28. avgust 2017
English: 2 Week Follow-up e
Slovenian: Spremljanje po 2 tednih e
English: C. albicans Non-albicans species
Slovenian: C. albicans Vrsta ne-albicans
English: 98.3% confidence intervals, adjusted post hoc for multiple comparisons of secondary time points.
Slovenian: 98,3-odstotni interval zaupanja, prilagojen post hoc za multiple primerjave sekundarnih časovnih točk
English: Twenty one (16.3%) had concomitant candidemia.
Slovenian: Enaindvajset (16,3 %) jih je sočasno imelo kandidemijo.
English: You should not be given a double dose by doctor.
Slovenian: Zdravnik vam ne sme dati dvojnega odmerka.
English: A successful global response required clinical improvement and microbiological eradication.
Slovenian: Uspešen globalni odziv je zahteval klinično izboljšanje in mikrobiološko izkoreninjenje.
English: The reconstituted solution has a pH of 3.5 to 5.5.
Slovenian: Rekonstituirana raztopina ima pH od 3,5 do 5,5.
English: This medicine contains fructose (a type of sugar).
Slovenian: To zdravilo vsebuje fruktozo (vrsto sladkorja).
English: Both regimens were welltolerated by these patients.
Slovenian: Ti bolniki so obe shemi dobro prenašali.
English: Not known (frequency cannot be estimated from the available data) are:
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: For the clinical relevance of these findings see “Clinical efficacy and safety.”
Slovenian: Za klinični pomen teh izsledkov glejte poglavje »Klinična učinkovitost in varnost«.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo ne smejo dobiti tega zdravila.
English: ECALTA will always be prepared and given to you by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).
Slovenian: Zdravilo ECALTA bo vedno pripravil in vam ga dal zdravnik ali zdravstveni delavec (več informacij o načinu priprave je na koncu tega navodila v poglavju, namenjenemu samo zdravstvenim delavcem).
English: Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
Slovenian: Zdravljenje je mogoče uvesti, preden so znani rezultati kulture, in ga ustrezno prilagoditi, ko so rezultati na voljo.
English: A total of 129 patients were included in the analysis.
Slovenian: V analizo so vključili skupno 129 bolnikov.
English: HIV positivity
Slovenian: HIV-pozitivnost
English: A total of 46 patients were included in the analysis.
Slovenian: V analizo so vključili skupno 46 bolnikov.
English: The safety and efficacy of ECALTA in children and adolescents below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila ECALTA pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: Your doctor will determine the duration of your treatment and how much ECALTA you will receive each day and will monitor your response and condition.
Slovenian: Zdravnik bo določil, koliko časa bo trajalo vaše zdravljenje in koliko zdravila ECALTA boste dobili dnevno; prav tako bo spremljal vaš odziv in vaše stanje.
English: Most clinical cases involve caspofungin treatment.
Slovenian: Večina kliničnih primerov vključuje zdravljenje s kaspofunginom.
English: However tell your doctor or pharmacist if you think that a dose has been forgotten.
Slovenian: Vendar pa zdravniku ali farmacevtu povejte, če mislite, da je bil odmerek pozabljen.
English: If you receive more ECALTA than you should
Slovenian: Če dobite več zdravila ECALTA, kot bi smeli
English: Apache II score ≤ 20 Apache II score  20
Slovenian: Seštevek Apache II ≤ 20 Seštevek Apache II  20
English: Patients were followed for six weeks beyond the end of all therapy.
Slovenian: Bolnike so spremljali šest tednov po koncu celotnega zdravljenja.
English: The table below provides the volumes required for each dose.
Slovenian: Spodnja preglednica navaja količine, potrebne za vsak odmerek.
English: A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed.
Slovenian: Ugotovili so majhno interindividualno variabilnost v sistemski izpostavljenosti (koeficient variacije ~25 %).
English: This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili ali elektroliti, razen s tistimi, ki so omenjena/-i v poglavju 6.6.
English: In multiple-dose patient studies, drug clearance was slightly faster (approximately 22%) in men.
Slovenian: V študijah z več odmerki pri bolnikih je bil očistek zdravila pri moških nekoliko večji (za približno 22 %).
English: The mean APACHE II score was 14.9 (range, 2 - 44).
Slovenian: Povprečni seštevek APACHE II je bil 14,9 (razpon 2-44).
English: Efficacy data, both overall and by various subgroups, are presented below in Table 3.
Slovenian: Podatki o učinkovitosti, tako celotni kot po raznih podskupinah, so zajeti v preglednici 3, spodaj.
English: Some of these side effects will be noted by your doctor while monitoring your response and condition.
Slovenian: Nekatere od teh neželenih učinkov bo opazil zdravnik, ko bo spremljal vaš odziv na zdravljenje in vaše stanje.
English: Effective contraception should be used in women of childbearing age.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo.
English: The majority of patients had Apache II scores ≤ 20 and very few were neutropenic.
Slovenian: Večina bolnikov je imela seštevek Apache II ≤ 20 in zelo redki so bili nevtropenični.
English: - Life-threatening allergic reactions
Slovenian: - življenjsko ogrožajoče alergijske reakcije
English: Duration of treatment In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Slovenian: Trajanje zdravljenja Praviloma je treba antimikotično zdravljenje nadaljevati vsaj še 14 dni po zadnji pozitivni kulturi.
English: Anidulafungin has negligible renal clearance (<1%).
Slovenian: Anidulafungin ima zanemarljiv ledvični očistek (< 1 %).
English: Treatment of invasive candidiasis in adult patients (see sections 4.4 and 5.1).
Slovenian: Zdravljenje invazivne kandidoze pri odraslih bolnikih (glejte poglavji 4.4 in 5.1).
English: Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Other Candida spp.
Slovenian: Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Druge vrste Candida nezadostni dokazi
English: The majority of patients had candidemia only.
Slovenian: Večina bolnikov je imela samo kandidemijo.
English: The clearance of anidulafungin is about 1 l/h.
Slovenian: Očistek anidulafungina je približno 1 l/h.
English: Treatment was administered for at least 14 and not more than 42 days.
Slovenian: Zdravljenje so prejemali vsaj 14 in ne več kot 42 dni.
English: This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
Slovenian: Infundiranje bo trajalo vsaj 1,5 ure za vzdrževalni odmerek in 3 ure za polnilni odmerek.
English: Anidulafungin is extensively bound (>99%) to human plasma proteins.
Slovenian: Anidulafungin je v veliki meri (> 99 %) vezan na beljakovine v človeški plazmi.
English: Waste materials should be disposed of in accordance with local requirements.
Slovenian: Odpadni material zavrzite v skladu z lokalnimi predpisi.
English: The reconstitution time can be up to 5 minutes.
Slovenian: Čas rekonstitucije je lahko do 5 minut.
English: These medicines are used to treat serious fungal infections.
Slovenian: Ta zdravila uporabljamo za zdravljenje hudih glivičnih okužb.
English: The majority of patients had candidemia only (84.8%; 39/46).
Slovenian: Večina bolnikov je imela samo kandidemijo (84,8 %; 39/46).
English: Minimum duration of infusion
Slovenian: Minimalno trajanje infuzije
English: Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose.
Slovenian: Koncentracija anidulafungina je padla pod spodnjo mejo kvantifikacije 6 dni po odmerku.
English: No clinical adverse reactions were reported.
Slovenian: O kliničnih neželenih učinkih niso poročali.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: All-cause mortality by Day 28 was 10/35 (28.6%).
Slovenian: Umrljivost zaradi vseh vzrokov je bila do 28. dneva 10/35 (28,6 %).
English: Global Response of Success at EOIVT
Slovenian: Uspešnost globalnega odziva ob EOIVT
English: The majority of patients had candidemia only (85.7%).
Slovenian: Večina bolnikov je imela samo kandidemijo (85,7 %).
English: Activity in vitro
Slovenian: Delovanje in vitro
English: ECALTA prevents normal development of fungal cell walls.
Slovenian: Zdravilo ECALTA preprečuje normalen razvoj celične stene glivic.
English: The expiry data refers to the last day of that month.
Slovenian: Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Total reconstituted volume
Slovenian: Celotna rekonstituirana količina
English: Mortality Anidulafungin Fluconazole
Slovenian: Umrljivost anidulafungin flukonazol
English: Two hundred and fifty-six patients, ranging from 16 to 91 years in age, were randomised to treatment and received at least one dose of study medication.
Slovenian: Na zdravljenje so randomizirali 256 bolnikov, starih od 16 do 91 let, ki so prejeli vsaj en odmerek preskušanega zdravila.
English: Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of anidulafungin.
Slovenian: Dolgoročne študije na živalih za oceno kancerogenega potenciala anidulafungina niso bile izvedene.
English: There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Slovenian: Ni dovolj podatkov, ki bi podpirali več kot 35-dnevno zdravljenje z odmerkom 100 mg.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ecalta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja ali prenehanjem/prekinitvijo zdravljenja z zdravilom ECALTA, pri čemer je treba pretehtati koristi dojenja za otroka in koristi zdravljenja za mater.
English: Less than 1% of the administered radioactive dose was excreted in the urine, indicating negligible renal clearance.
Slovenian: Manj kot 1 % danega radioaktivnega odmerka se je izločil v urinu, kar kaže na zanemarljiv ledvični očistek.
English: Do not use ECALTA - if you are allergic to anidulafungin, other echinocandins (e.g.caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila ECALTA - če ste alergični na anidulafungin, druge ehinokandine (npr. kaspofunginijev acetat) ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: ECALTA is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Slovenian: Uporaba zdravila ECALTA med nosečnostjo ni priporočljiva, razen če koristi za mater upravičujejo potencialno tveganje za plod.
English: Not relevant.
Slovenian: Podatek ni pomemben.
English: What ECALTA is and what it is used for
Slovenian: Kaj je zdravilo ECALTA in za kaj ga uporabljamo
English: Of note, in vitro studies do not fully exclude possible in vivo interactions.
Slovenian: Omeniti pa je treba, da študije in vitro možnih interakcij in vivo ne izključujejo v celoti.
English: In the presence of ECALTA, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
Slovenian: Celice glivic, izpostavljene zdravilu ECALTA, imajo nepopolno ali okvarjeno celično steno, zato so krhke in ne morejo rasti.
English: Patients who received at least one dose of study medicinal products and who had a positive culture for Candida species from a normally sterile site before study entry were included in the modified intentto-treat (MITT) population.
Slovenian: Bolniki, ki so dobili vsaj en odmerek preskušanega zdravila in so imeli pozitivno kulturo za vrste Candida z normalno sterilnega mesta pred vstopom v preskušanje, so bili vključeni v modificirano populacijo z-namenom-zdravljenja (MITT - Modified Intention To Treat).
English: Pharmacotherapeutic group: - Antimycotics for systemic use, other antimycotics for systemic use.ATC code: JO2AX06
Slovenian: Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, drugi antimikotiki; oznaka ATC: J02AX06
English: Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk.
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje anidulafungina v mleko.
English: Isolates with mutations in the hot spot regions of the target gene have been associated with clinical failures or breakthrough infections.
Slovenian: Izolati z mutacijami na žariščnih območjih tarčnega gena so bili povezani s klinično neuspešnostjo ali izbruhi okužbe.
English: If you forgot to use ECALTA
Slovenian: Če ste pozabili uporabiti zdravilo ECALTA
English: The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to 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) and from spontaneous reports with frequency not known (cannot be estimated from the available data).
Slovenian: Naslednja preglednica vsebuje neželene učinke zaradi vseh vzrokov (MedDRA izrazi) pri 840 preskušancih, ki so prejemali 100 mg anidulafungina, s pogostnostjo: 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), in iz spontanih poročil s pogostnostjo 'neznana' (ni mogoče oceniti iz razpoložljivih podatkov).
English: Rats were dosed with anidulafungin at three dose levels and anaesthetised within one hour using a combination of ketamine and xylazine.
Slovenian: Podgane so dobivale anidulafungin v treh ravneh odmerkov in bile v roku ene ure anestezirane s kombinacijo ketamina in ksilazina.
English: Plasma concentrations of anidulafungin in healthy men and women were similar.
Slovenian: Koncentracija anidulafungina v plazmi zdravih moških in žensk je podobna.
English: If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.
Slovenian: Če se pojavi takšna reakcija, je treba z uporabo anidulafungina prekiniti in uvesti ustrezno zdravljenje.
English: Approximately 30% of the administered radioactive dose was eliminated in the faeces over 9 days, of which less than 10% was intact drug.
Slovenian: Približno 30 % danega radioaktivnega odmerka se je izločilo v blatu v 9 dneh, od tega je bilo manj kot 10 % nespremenjenega zdravila.
English: Anidulafungin has a predominant elimination half-life of approximately 24 hours that characterizes the majority of the plasma concentration-time profile, and a terminal half-life of 40-50 hours that characterises the terminal elimination phase of the profile.
Slovenian: Anidulafungin ima prevladujoč razpolovni čas izločanja približno 24 ur, ki opredeljuje glavnino profila koncentracije v plazmi v odvisnosti od časa in terminalni razpolovni čas 40-50 ur, ki opredeljuje terminalno izločevalno fazo tega profila.
English: The efficacy of ECALTA has only been evaluated in a limited number of neutropenic patients (see section 5.1).
Slovenian: Učinkovitost zdravila ECALTA je bila ocenjena le pri omejenem številu bolnikov z nevtropenijo (glejte poglavje 5.1).
English: Other medicines and ECALTA
Slovenian: Druga zdravila in zdravilo ECALTA
English: ECALTA contains the active substance anidulafungin and is prescribed in adults to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis.
Slovenian: Zdravilo ECALTA vsebuje učinkovino anidulafungin in se uporablja pri odraslih za zdravljenje posebne vrste glivične okužbe krvi ali drugih notranjih organov, imenovane invazivna kandidoza.
English: Anidulafungin treatment prolonged survival and also reduced the organ burden of Candida species, when determined at intervals from 24 to 96 hours after the last treatment.
Slovenian: Zdravljenje z anidulafunginom je podaljšalo preživetje in zmanjšalo obremenjenost organov z vrstami Candida, ugotavljano v intervalu od 24 do 96 ur po zadnjem zdravljenju.
English: Activity in vivo
Slovenian: Aktivnost in vivo
English: Your doctor may decide to monitor you - for liver function more closely if you develop liver problems during your treatment.
Slovenian: Zdravnik se bo morda odločil, da vas natančneje spremlja: - če se vam med zdravljenjem pojavijo težave z jetri; v tem primeru bo pazljivo spremljal delovanje vaših jeter.
English: C. parapsilosis harbours an intrinsic alteration in the target gene, which is the likely mechanism for the higher MICs than with other Candida species.
Slovenian: C. parapsilosis ima intrinzično spremembo na tarčnem genu, ki je verjetni mehanizem za večje vrednosti MIK kot pri drugih vrstah Candida.
English: Additional Data in Neutropenic Patients
Slovenian: Dodatni podatki pri nevtropeničnih bolnikih
English: (for pH-adjustment), hydrochloric acid (for pH-adjustment)
Slovenian: (za prilagoditev pH), klorovodikova kislina (za prilagoditev pH)
English: ECALTA should not be given to patients under 18 years of age.
Slovenian: Otroci in mladostniki Zdravila ECALTA ne smejo dobiti bolniki, mlajši od 18 let.
English: Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal infections.
Slovenian: Zdravljenje z zdravilom ECALTA mora uvesti zdravnik, ki ima izkušnje z obvladovanjem invazivnih glivičnih okužb.
English: As with any overdose, general supportive measures should be utilised as necessary.
Slovenian: Uporabiti je treba splošne podporne ukrepe, kakor je potrebno, tako kot v vsakem primeru prevelikega odmerjanja.
English: Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
Slovenian: Anidulafungin ni klinično pomemben substrat, induktor ali zaviralec izoencimov citokroma P450 (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
English: A standardized technique for testing the susceptibility of Candida species to anidulafungin as well as the respective interpretative breakpoints has been established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Slovenian: Stadardizirano tehniko za testiranje občutljivosti vrste Candida na anidulafungin, kot tudi ustrezne mejne vrednosti, je določil Evropski odbor za testiranje občutljivosti na protimikrobna zdravila (EUCAST).
English: MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
Slovenian: Mejna vrednost MIK (mg/l) ≤ S (občutljiv) > R (odporen)
English: Ethnicity Anidulafungin pharmacokinetics were similar among Caucasians, Blacks, Asians, and Hispanics.
Slovenian: Etnična pripadnost Farmakokinetika anidulafungina je pri belcih, črncih, azijcih in hispanih podobna.
English: Anidulafungin displays linear pharmacokinetics across a wide range of once daily doses (15-130 mg).
Slovenian: Anidulafungin ima linearno farmakokinetiko v širokem razponu odmerkov enkrat na dan (15-130 mg).
English: The in vitro activity of anidulafungin against Candida species is not uniform.
Slovenian: In vitro aktivnost anidulafungina proti vrstam Candida ni enotna.
English: No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2).
Slovenian: Odmerjanja pri odraslih bolnikih glede na spol, telesno maso, etnično pripadnost, HIV-pozitivnost ali pri starejših bolnikih ni treba prilagajati (glejte poglavje 5.2).
English: Hypersensitivity to other medicinal products of the echinocandin class.
Slovenian: Preobčutljivost na druga zdravila iz skupine ehinokandinov.
English: If you are concerned that you may have been given too much ECALTA, tell your doctor or another healthcare professional immediately.
Slovenian: Če vas skrbi, da ste dobili preveč zdravila ECALTA, to nemudoma povejte zdravniku ali drugemu zdravstvenemu delavcu.
English: Developmental effects observed in rabbits (slightly reduced foetal weights) occurred only at the highest dose tested, a dose that also produced maternal toxicity.
Slovenian: Razvojni učinki, ugotovljeni pri kuncih (rahlo zmanjšanje telesne mase plodov), so se pojavili le pri največjem preskušanem odmerku; ta odmerek je povzročil tudi toksične učinke pri samici materi.
English: Administration of anidulafungin to rats did not indicate any effects on reproduction, including male and female fertility.
Slovenian: Uporaba anidulafungina pri podganah ni pokazala vplivov na sposobnost razmnoževanja, vključno s plodnostjo samcev in samic.
English: Additional Data in Patients with Deep Tissue Infections
Slovenian: Dodatni podatki pri bolnikih z okužbami globokega tkiva
English: Systemic exposure following daily maintenance dose of 0.75 and 1.5 mg/kg/day in this population were comparable to those observed in adults following 50 and 100 mg/day, respectively.
Slovenian: Sistemska izpostavljenost po dnevnem vzdrževalnem odmerku 0,75 oz. 1,5 mg/kg/dan je bila v tej populaciji primerljiva tisti pri odraslih, ki so dobivali 50 mg oz. 100 mg/dan.