natgillin/translations-raw huggingface dataset:
Children treated with Unituxin will first have responded to chemotherapy and then received an additional treatment to clear out their bone marrow (myeloablative therapy) and a stemcell transplantation.
Otroci, zdravljeni z zdravilom Unituxin, se morajo najprej odzvati na kemoterapijo, potem pa prestati dodatno zdravljenje za prečiščenje kostnega mozga (mieloablacijsko terapijo) in presaditev matičnih celic.
Unituxin is used to treat children with ‘high-risk' neuroblastoma, the form of the cancer that has a high chance of returning.
Zdravilo Unituxin se uporablja za zdravljenje otrok z nevroblastomom z „visokim tveganjem“, tj. obliko raka, za katero obstaja velika možnost ponovitve.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Unituxin, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Unituxin in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the risks associated with Unituxin?
Kakšna tveganja so povezana z zdravilom Unituxin?
Patients should also be given an antihistamine medicine before the start of each Unituxin infusion to reduce the risk of a reaction.
Pred začetkom vsakega infundiranja zdravila Unituxin je treba bolniku prav tako dati antihistaminik, da se zmanjša tveganje take reakcije.
The full EPAR and risk management plan summary for Unituxin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Unituxin sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Why is Unituxin approved?
Zakaj je bilo zdravilo Unituxin odobreno?
A main study conducted in 230 patients with high-risk neuroblastoma showed that Unituxin (given with isotretinoin, GM-CSF and interleukin-2) was more effective than isotretinoin alone at keeping patients alive and preventing the re-emergence of their cancer.
V glavni študiji, izvedeni pri 230 bolnikih z nevroblastomom z visokim tveganjem, so pokazali, da je bilo zdravilo Unituxin (ki se je dajalo z izotretinoinon, GM-CSF in interlevkinom-2) učinkovitejše kot samostojen izotretinoin pri ohranjanju bolnikov pri življenju in preprečevanju ponovnega pojava raka.
The active substance in Unituxin, dinutuximab, is a monoclonal antibody, designed to recognise and attach to a substance present at high levels in neuroblastoma cancer cells known as ganglioside GD2.
Zdravilna učinkovina v zdravilu Unituxin, dinutuksimab, je monoklonsko protitelo, ki prepoznava in se veže na snov, ki je v velikih koncentracijah prisotna v rakavih celicah nevroblastoma in se imenuje gangliozid GD2.
Because pain is a common side of Unituxin treatment, patients are also given pain killers.
Ker je bolečina pogost neželen učinek zdravljenja z zdravilom Unituxin, bodo bolniki prejeli tudi protibolečinska zdravila.
For practical information about using Unituxin, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Unituxin naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The patient also receives 3 other medicines: isotretinoin,
Bolnik prejme tudi tri druga zdravila:
Unituxin is given in combination with 3 other medicines: GM-CSF, interleukin-2 and isotretinoin.
Zdravilo Unituxin se daje v kombinaciji s tremi drugimi zdravili: granulocitno-makrofagne kolonije stimulirajočim faktorjem (GM-CSF), interleukinom-2 in izotretinoinom.
Unituxin is given as an infusion (drip) into a vein.
Zdravilo Unituxin se daje z infundiranjem (kapalno infuzijo) v veno.
How does Unituxin work?
Kako zdravilo Unituxin deluje?
How is Unituxin used?
Kako se zdravilo Unituxin uporablja?
Unituxin contains the active substance dinutuximab.
Zdravilo Unituxin vsebuje zdravilno učinkovino dinutuksimab.
This overview was last updated in April 2019.
Ta povzetek je bil nazadnje posodobljen aprila 2019.
This will help protect the pig against the disease.
To pomaga zaščititi prašiča pred boleznijo.
In the future, the immune system will be able to react against the virus more quickly.
Tako bo v prihodnosti imunski sistem lahko hitreje reagiral proti njemu.
Further information on Suvaxyn PRRS MLV can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/suvaxyn-prrs-mlv.
Nadaljnje informacije o zdravilu Suvaxyn PRRS MLV so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/suvaxyn-prrs-mlv
The European Medicines Agency decided that Suvaxyn PRRS MLV's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Suvaxyn PRRS MLV večje od z njim povezanih tveganj, in da se lahko odobri za uporabo v EU.
Mass vaccination can take place in herds in which presence of European PRRS virus is known.
Masovno cepljenje se lahko uporabi v čredah, kjer je ugotovljena prisotnost evropskega virusa PRRS.
The most common side effects with Suvaxyn PRRS MLV are a short lived increase in body temperature (0.5-0.8 °C on average), which may affect more than 1 in 10 pigs within 4 days of vaccination, and local reactions in the form of swellings which resolve without treatment in 5 to 9 days.
Najpogostejši neželeni učinki zdravila Suvaxyn PRRS MLV so kratkotrajen porast telesne temperature (v povprečju 0,5-0,8 C), ki lahko prizadene več kot 1 od 10 prašičev v štirih dneh po cepljenju, ter lokalne reakcije v obliki oteklin, ki izginejo brez zdravljenja v petih do devetih dneh.
When a pig is given the vaccine, the pig's immune system recognises the virus as ‘foreign' and makes antibodies against it.
Ko prašič prejme cepivo, imunski sistem prepozna virus kot „tujek“ in proti njemu tvori protitelesa.
Suvaxyn PRRS MLV received a marketing authorisation valid throughout the EU on 24 August 2017.
Zdravilo Suvaxyn PRRS MLV je pridobilo dovoljenje za promet, veljavno po vsej EU, 24. avgusta 2017.
Suvaxyn PRRS MLV must not be used in herds where European PRRS virus has not been detected by reliable diagnostic methods.
Zdravilo Suvaxyn PRRS MLV se ne sme uporabljati v čredah, kjer evropski virus PRRS ni bil odkrit z zanesljivimi diagnostičnimi metodami.
Gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets) are given a single injection before introduction into the sow herd, about 4 weeks before breeding, and a booster injection every 6 months.
Svinjam mladicam (samicam, ki še niso imele prašičkov) in plemenskim svinjam (samicam, ki so že imele prašičke) se vbrizga enkratna injekcija pred vključitvijo v čredo plemenskih svinj, približno štiri tedne pred brejostjo, in obnovitveni odmerek vsakih šest mesecev.
Suvaxyn PRRS MLV contains a modified strain of live PRRS virus, strain 96V198, that has been weakened so that it does not cause disease.
Zdravilo Suvaxyn PRRS MLV vsebuje modificiran sev živega virusa PRRS, sev 96V198, ki je bil oslabljen, tako da ne povzroča bolezni.
There may also be disease of the airways which can lead to high death rates in suckling and weaned pigs.
Pojavi se lahko tudi bolezen dihal, ki lahko zviša umrljivost pri sesnih in odstavljenih prašičkih.
This viral disease of pigs may result in lowered farrowing (birth) rates, increase in abortions, stillborn, mummified as well as weak live born piglets and deaths.
Ta virusna bolezen lahko povzroči zmanjšanje števila prasitev, povečanje pojavov zvrgavanja, števila mrtvorojenih in mumificiranih prašičkov, slabotnih prašičkov ob rojstvu ter smrti.
For further information about using Suvaxyn PRRS MLV, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Suvaxyn PRRS MLV glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
The withdrawal period for meat from pigs treated with Suvaxyn PRRS MLV is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso prašičev, ki so prejeli cepivo Suvaxyn PRRS MLV, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
In pregnant gilts and sows with no prior exposure to PRRS virus, Suvaxyn PRRS MLV must not be used in the second half of pregnancy because the virus in the vaccine may cross the placenta and affect the birth rate.
Pri brejih mladicah in plemenskih svinjah, ki nikoli niso bile izpostavljene virusu PRRS, se zdravilo Suvaxyn PRRS MLV ne sme uporabljati v drugi polovici brejosti, ker virus v cepivu lahko prehaja skozi placento in vpliva na zmožnost reprodukcije.
Other information about Suvaxyn PRRS MLV
Druge informacije o zdravilu Suvaxyn PRRS MLV
Two studies were conducted in female pigs, one which showed that single vaccination of female pigs 10 to 11 weeks before mating protected them against disease when exposed to the virus 26 weeks after vaccination.
Izmed dveh študij, ki so ju izvedli pri svinjah samicah, je ena pokazala, da enkratna injekcija, ki se daje od 10 do 11 tednov pred parjenjem, svinje zaščiti pred boleznimi, če so virusu izpostavljene 26 tednov po cepljenju.
Protection starts to be effective 21 days after vaccination and lasts for 26 weeks after vaccination.
Učinkovati začne 21 dni po cepljenju, zaščita pa traja 26 tednov po cepljenju.
Why is Suvaxyn PRRS MLV authorised in the EU?
Zakaj je bilo zdravilo Suvaxyn PRRS MLV odobreno v EU?
Suvaxyn PRRS MLV is a vaccine.
Zdravilo Suvaxyn PRRS MLV je cepivo.
Suvaxyn PRRS MLV is a veterinary vaccine used to protect pigs against porcine respiratory and reproductive syndrome (PRRS).
Zdravilo Suvaxyn PRRS MLV je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito prašičev pred prašičjim reprodukcijskim in respiratornim sindromom (PRRS).
An overview of Suvaxyn PRRS MLV and why it is authorised in the EU
Pregled zdravila Suvaxyn PRRS MLV in zakaj je odobreno v EU
A study in piglets showed the vaccine starts to be effective 21 days after vaccination and four studies in piglets showed protection lasts up to 26 weeks.
Ena študija pri prašičkih je pokazala, da zdravilo začne učinkovati 21 dni po cepljenju, v štirih študijah pri prašičkih pa je bilo dokazano, da zaščita traja do 26 tednov.
The second study in sows showed that a booster vaccination 6 months after the initial vaccination, with mating performed 4 months after the second vaccination, gave protection for 7 months.
Druga študija pri svinjah je pokazala, da obnovitveni odmerek šest mesecev po začetnem cepljenju in po parjenju, ki se izvede štiri mesece po drugem cepljenju, zaščiti svinje za sedem mesecev.
What is Suvaxyn PRRS MLV and what is it used for?
Kaj je zdravilo Suvaxyn PRRS MLV in za kaj se uporablja?
For the full list of all side effects and restrictions with Suvaxyn PRRS MLV, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Suvaxyn PRRS MLV, glejte navodilo za uporabo.
Suvaxyn PRRS MLV contains a weakened strain of PRRS virus.
Zdravilo Suvaxyn PRRS MLV vsebuje oslabljen sev virusa PRRS.
What benefits of Suvaxyn PRRS MLV have been shown in studies?
Kakšne koristi je zdravilo Suvaxyn PRRS MLV izkazalo v študijah?
Suvaxyn PRRS MLV is available as lyophilisate (a freeze-dried pellet) and solvent to make a suspension for injection and can only be obtained with a prescription.
Zdravilo Suvaxyn PRRS MLV je na voljo v obliki liofilizata (pelet, sušenih z zamrzovanjem) in vehikla za suspenzijo za injiciranje.
What are the risks associated with Suvaxyn PRRS MLV?
Kakšna tveganja so povezana z zdravilom Suvaxyn PRRS MLV?
Suvaxyn PRRS MLV is given as a single injection from 1 day of age to pigs for fattening.
Zdravilo Suvaxyn PRRS MLV se daje pitancem od enega dneva starosti kot enkratna injekcija.
Suvaxyn PRRS MLV must also not be used in boars producing semen, as PRRS virus can be shed in semen.
Cepivo se ravno tako ne sme uporabljati pri plemenskih merjascih, ki so namenjeni za proizvodnjo semena, saj se virus PRRS lahko širi prek semena.
How is Suvaxyn PRRS MLV used?
Kako se zdravilo Suvaxyn PRRS MLV uporablja?
The effectiveness of Suvaxyn PRRS MLV was supported by laboratory studies.
Laboratorijske študije podpirajo učinkovitost zdravila Suvaxyn PRRS MLV.
How does Suvaxyn PRRS MLV work?
Kako zdravilo Suvaxyn PRRS MLV deluje?
The main studies supporting intravaginal application are Studies SCO 5109 and SCO 5174.
Glavni študiji, ki podpirata intravaginalno uporabo, sta SCO 5109 in SCO 5174.
Whereas
Vendar na podlagi
1 Clinical Gynaecologic Endocrinology and Infertility, 8e, Marc A Fritzand, Leon Speroff (Chapter 17: menopause and the peri-menopausal transition)
1 Clinical Gynaecologic Endocrinology and Infertility, 8e, Marc A Fritzand, Leon Speroff (Poglavje 17: menopause and the peri-menopausal transition)
In terms of pharmacovigilance data, a total of 11 cases were reported including spontaneous reports and literature cases.
V farmkovigilančnih podatkih so poročali o skupno 11 primerih, vključno s spontanimi poročili in primeri iz literature.
Linoladiol N and Linoladiol HN are approved via national procedures in different member states.
Zdravili Linoladiol N in Linoladiol HN sta v različnih državah članicah odobreni z nacionalnimi postopki.
The peak concentration of estradiol was reached 6 hours after application (median).
Največja koncentracija estradiola se je dosegla 6 ur po uporabi (mediana).
Thus, they disagreed with some of the amendments proposed by the CHMP to be implemented in the product information.
Zato se ni strinjal z nekaterimi spremembami, ki jih je odbor CHMP predlagal za vključitev v informacije o zdravilu.
In addition, the clear reference to the patient population (postmenopausal women) intended to treat should be added.
Poleg tega je treba jasno navesti populacijo bolnic, kateri je namenjeno zdravljenje (postmenopavzalne ženske).
Systemic levels of estradiol in these two studies raised concerns.
Zaradi sistemskih ravni estradiola v teh študijah so se pojavili pomisleki.
The CHMP carried out a new assessment of the available efficacy data in the concerned indication.
Odbor CHMP je opravil ponovno oceno razpoložljivih podatkov o učinkovitosti pri zadevni indikaciji.
High dose estradiol products such as Linoladiol N are not specifically considered in these recommendations.
Zdravila z visokimi odmerki estradiola, kot je Linoladiol N, v teh priporočilih niso posebej obravnavana.
The CHMP therefore recommended the deletion of this indication from the product information.
Odbor CHMP je zato priporočil izbris te indikacije iz informacij o zdravilu.
The adjusted mean Cδmax (92.2 pg/ml) amounted to 89% of the total Cmax.
Prilagojena povprečna vrednost Cδmax (92,2 pg/ml) je bila 89 % skupne vrednosti Cmax.
Decreases in FSH and LH were also observed, further reflecting the existence of relevant systemic exposure.
Opaženo je bilo tudi zmanjšanje ravni FSH in LH, kar še nadalje odraža obstoj klinično pomembne sistemske izpostavljenosti.
An increase in oestrogen-related risk with recurrent use of this product cannot be ruled out.
Povečanega tveganja, povezanega z estrogeni, pri ponavljajoči se uporabi zdravila ni mogoče izključiti.
An historical analysis of pharmacokinetic data of estradiol after vaginal application across several published studies has been performed.
Opravljena je bila zgodovinska analiza farmakokinetičnih podatkov o estradiolu po vaginalni uporabi iz več objavljenih študij.
Germany was concerned that these products containing estradiol, which are indicated only for local use, exhibit high blood concentration upon application, which is seen only with products authorised for systemic use.
Nemčija je imela zadržke, da ta zdravila, ki vsebujejo estradiol in so indicirana samo za lokalno uporabo, ob uporabi povzročajo veliko koncentracijo v krvi, kar so opazili samo pri zdravilih, odobrenih za sistemsko uporabo.
• The Committee reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, on the efficacy and safety these medicinal products for topical use.
• odbor je pregledal vse razpoložljive podatke iz kliničnih študij, farmakoepidemioloških študij, objavljene literature in izkušenj v obdobju trženja, vključno z odgovori, ki so jih v obliki pisnih in ustnih obrazložitev podali imetniki dovoljenj za promet, v zvezi z učinkovitostjo in varnostjo teh zdravil za topično uporabo;
The primary objective of the study was to estimate the extent of estradiol exposure after application of the test formulation Linoladiol N.
Primarni cilj študije je bila ocena obsega izpostavljenosti estradiolu po uporabi preiskovane formulacije zdravila Linoladiol N.
The mean value of AUC0-36 (1285.2 pg/ml·h) and Cmax (103.5 pg/ml) indicate systemic exposure to estradiol from the intravaginal cream.
Povprečni vrednosti AUC0-36 (1285,2 pg/ml·h) in Cmax (103,5 pg/ml) kažeta na sistemsko izpostavljenost estradiolu, ki jo povzroča intravaginalna krema.
However due to no specific safety reports to-date and the known lack of sensitivity of spontaneous reporting, only the well-known risks of systemic HRT are to be expected.
Ker pa ni specifičnih poročil o varnosti in zaradi znane pomanjkljivosti občutljivosti pri spontanem poročanju, se pričakujejo samo dobro znana tveganja sistemskega hormonskega nadomestnega zdravljenja.
Clear information should be reflected in the posology section.
V poglavje o odmerjanju je prav tako treba vključiti jasne informacije.
Furthermore, due to the content of the corticosteroid prednisolone, use of Linoladiol HN is recommended only for short-term therapy (up to four weeks).
Zaradi vsebnosti kortikosteroida prednizolona, je uporaba zdravila Linoladiol HN priporočena samo za kratkotrajno zdravljenje (do štiri tedne).
Following the adoption of the CHMP opinion and recommendations during the December 2013 CHMP meeting, a re-examination request on Linoladiol N medicinal product only was received from one MAH.
Po sprejetju mnenja in priporočil odbora CHMP na sestanku odbora CHMP v decembru 2013 je en imetnik dovoljenja za promet z zdravilom predložil zahtevo samo za ponoven pregled zdravila Linoladiol N.
The CHMP noted that the available data on the safety of Linoladiol is limited and no prospective evaluation of safety, in particular endometrial safety was available.
Odbor CHMP je ugotovil, da so razpoložljivi podatki o varnosti zdravila Linoladiol omejeni in da prospektivna ocena varnosti, predvsem za endometrij, ni na voljo.
In order to enforce this short duration of use, the CHMP requested withdrawal of the pack sizes of 100 g in all EU Members States where the products are authorised, as this large pack size of cream is considered redundant under the new recommendations for the duration of use.
Da bi okrepili kratko trajanje uporabe, je odbor CHMP zahteval umik velikosti pakiranja po 100 g v vseh državah članicah EU, kjer so ta zdravila odobrena, saj je tako veliko pakiranje kreme nepotrebno v skladu z novimi priporočili za trajanje uporabe.
In May 2012, Germany (BfArM) requested the evaluation of the overall benefit risk balance of high concentration estradiol (E2) containing medicinal products indicated for topical use for the treatment of vaginal atrophy (intravaginally and on the skin of vulva and vagina).
Maja 2012 je Nemčija (BfArM) zaprosila za oceno splošnega razmerja med tveganji in koristmi za zdravila z veliko koncentracijo estradiola (E2), indicirana za topično uporabo pri zdravljenju nožnične atrofije (znotraj nožnice in na koži vulve ter nožnice).
Overall summary of the scientific evaluation of high concentration estradiol containing medicinal products for topical use
Splošni povzetek znanstvenega vrednotenja zdravil z veliko koncentracijo estradiola za topično uporabo
In particular, the CHMP re-assessed the pharmacokinetic data available, as well as the comparison to existing treatments in consultation to the international guidelines.
Odbor CHMP je še posebej pozorno ponovno ocenil razpoložljive farmakokinetične podatke in primerjavo z obstoječimi oblikami zdravljenja v skladu z mednarodnimi smernicami.
Prolonged use is not recommended and skin irritation, hypersensitivity and spotting were reflected in the undesirable effects.
Podaljšana uporaba ni priporočljiva, draženje kože, preobčutljivost in mazanje pa so bili vključeni v poglavje o neželenih učinkih.
The weekly exposure is higher for Linoladiol N than with other products, and this raises safety concerns, in particular considering the potential for long-term systemic exposure in daily clinical practice.
Tedenska izpostavljenost pri zdravilu Linoladiol N je večja kot pri drugih zdravilih, zaradi česar so se pojavili pomisleki, predvsem glede potenciala za dolgotrajno sistemsko izpostavitev v vsakdanji klinični praksi.
Vigilance is required for possible systemic side effects and skin atrophy.
Pozornost je potrebna zaradi možnih sistemskih neželenih učinkov in kožne atrofije.
The systemic levels seen for this product with twice weekly administration are comparable to those seen for products in the medium range of estradiol dosing.
Sistemske ravni, opažene pri tem zdravilu ob uporabi dvakrat na teden, so primerljive z ravnmi, opaženimi pri zdravilih v srednjem razponu odmerjanja estradiola.
The CHMP took also into account the available data for Linoladiol HN, which was limited mainly to postmarketing data.
Odbor je prav tako obravnaval razpoložljive podatke za Linoladiol HN, ki so bili večinoma omejeni na podatke iz obdobja trženja.
The Committee accepted the MAH's argument that although current clinical guidelines differentiate between systemic and topical oestrogen treatments and clearly topical treatments are recommended for this condition, they do not make a recommendation for a ranking of the different topical treatments.
Odbor CHMP je sprejel trditev imetnika dovoljenja za promet z zdravilom, da četudi trenutne klinične smernice razlikujejo med sistemskimi ter topičnimi oblikami zdravljenja z estrogenom in so za to stanje jasno priporočene topične oblike zdravljenja, pa ne priporočajo prednostne razvrstitve različnih topičnih oblik zdravljenja.
• The Committee, in order to ensure that the 0.01% w/w estradiol containing medicinal products for topical use are not used for periods longer than 4 weeks, imposed the withdrawal of pack size of 100 g in all EU Members States where the products are authorised.
• za zagotovitev, da se zdravila za topično uporabo, ki vsebujejo 0,01 % m/m estradiola, ne uporabljajo dlje kot 4 tedne, je odbor zahteval umik velikosti pakiranja po 100 g v vseh državah članicah EU, kjer so ta zdravila odobrena.
With regards to the use of Linoladiol HN for the treatment of lichen sclerosus genitalis, the CHMP noted that according to the current clinical knowledge on the treatment of this condition, estradiol is not a treatment option.
Za uporabo zdravila Linoladiol HN za zdravljenje lichen sclerosus genitalis je odbor CHMP navedel, da glede na trenutno klinično znanje o zdravljenju tega stanja estradiol ni ustrezna možnost.
The mean baseline estradiol serum concentration was 11.3 pg/ml.
Povprečna izhodiščna koncentracija estradiola v serumu je bila 11,3 pg/ml.
In this comparison, three other intravaginally applied medicinal products were included: 10 mcg and 25 mcg vaginal tablets, and 2 mg vaginal ring.
V to primerjavo so bila vključena tri druga intravaginalna zdravila: 10 µg ter 25 µg vaginalne tablete in 2 mg vaginalni obroček.
Primary variables were AUCδ0-36 and Cδmax of estradiol, i.e. the extent of exposure was estimated as area under the baseline adjusted estradiol concentration curve and the baseline-adjusted maximal plasma concentration of estradiol.
Primarni spremenljivki sta bili vrednosti AUCδ0-36 in Cδmax estradiola, tj. obseg izpostavljenosti se je izračunal kot površina pod krivuljo koncentracije estradiola, prilagojene glede na izhodišče, in največje koncentracije estradiola v plazmi, prilagojene glede na izhodišče.