FrancophonIA/ELRC3.0 huggingface dataset:
English: As recent data have demonstrated, restarting or switching COC use after interruption is associated with an excess risk.
Slovenian: Kot so pokazali novejši podatki, sta ponoven začetek zdravljenja ali zamenjava kombiniranih peroralnih kontracepcijskih sredstev po prekinitvi jemanja povezana s povečanim tveganjem.
English: The recent Cochrane review (Arowojolu, AO. et al., 2012), which evaluated efficacy of combined oral contraceptives in acne, reported that regarding the differences in the comparative effectiveness of the contraceptives, data were too limited for any conclusive comparison.
Slovenian: Zadnji pregled skupine Cochrane (Arowojolu, AO. et al., 2012), ki je ocenjevala učinkovitost kombiniranih peroralnih kontracepcijskih sredstev pri aknah, je pokazal, da so podatki glede razlik v primerjalni učinkovitosti kontracepcijskih sredstev preveč omejeni za dokončne zaključke.
English: More recent studies assessing the VTE risk in users of various COCs and CPA/EE (including Lidegaard 2009, Hylckama 2009) had major methodological flaws (missing data for confounders) that raise questions about the validity of their conclusions.
Slovenian: Novejše študije, v katerih so ocenjevali tveganje za VTE pri uporabnicah kombiniranih peroralnih kontracepcijskih sredstev in CPA/EE (vključno z Lidegaard, 2009 in Hylckama, 2009), so imele velike metodološke pomanjkljivosti (manjkajoči podatki za sočasne dejavnike), zaradi katerih je vprašljiva zanesljivost zaključkov.
English: The primary outcomes of interest are cardiovascular events, in particular the incidence of VTE and ATE, during oral contraception use.
Slovenian: Primarni opazovani izidi so bili srčno-žilni dogodki, zlasti pojavnost VTE in ATE med uporabo peroralne kontracepcije.
English: Two large, ongoing post-marketing surveillance studies (INAS-OC and INAS-SCORE) yield incidental data on the use of CPA/EE.
Slovenian: Dve obsežni študiji, ki potekata v obdobju trženja (INAS-OC in INAS-SCORE), zbirata naključne podatke o uporabi CPA/EE.
English: As part of the risk minimisation measures the PRAC adopted an updated indication taking all the data into account, and making clear the conditions for which these products are indicated.
Slovenian: V okviru ukrepov za zmanjšanje tveganja je PRAC sprejel posodobljeno indikacijo v skladu z vsemi podatki in jasno opredelil zdravstvena stanja, za katera so tovrstna zdravila indicirana.
English: Furthermore, concomitant use of another hormonal contraceptive being reported as an additional suspected drug was documented in 21 (2.2%) of received TE cases; 20 patients received concomitantly various COCs and one case reported concomitant intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) use.
Slovenian: Poleg tega je bila sočasna uporaba drugega hormonskega kontracepcijskega sredstva zabeležena kot dodaten domnevni vzrok v 21 (2,2 %) primerih TED, o katerih so poročali; 20 bolnic je sočasno uporabljalo različna kombinirana peroralna kontracepcijska sredstva, v enem primeru pa so poročali o uporabi intrauterinega vložka (IUV) (intrauterinega sistema, ki sprošča levonorgestrel).
English: It has to be noted that Polycystic ovarian syndrome (PCOS) mentioned by HCPs as an indication reflects the use of CPA/EE for the treatment of androgen related symptoms of PCOS such as acne or hirsutism.
Slovenian: Omeniti je treba, da sindrom policističnih jajčnikov (PCOS), ki ga zdravstveni delavci navajajo kot indikacijo, odraža uporabo CPA/EE za zdravljenje simptomov PCOS, povezanih z androgeni, na primer aken ali hirzutizma.
English: However, based on the best evidence available, the authors concluded that the treatment containing cyproterone acetate improved acne better than a levonorgestrel-containing treatment; that treatment with cyproterone acetate showed better acne outcomes than one with desogestrel, but the studies produced conflicting results; and finally that drospirenone-containing treatment appeared to be more effective than norgestimate or nomegestrol acetate-containing treatment but less effective than treatment with cyproterone acetate.
Slovenian: Vendar pa so na podlagi najzanesljivejših razpoložljivih podatkov avtorji zaključili, da je zdravljenje s ciproteron acetatom v večji meri izboljšalo akne kot zdravljenje z levonorgestrelom; da so bili izidi zdravljenja aken s ciproteron acetatom boljši od izidov zdravljenja z dezogestrelom, vendar so bili rezultati študij nasprotujoči; ter tudi da je bilo zdravljenje z drospirenonom učinkovitejše od zdravljenja z norgestimatom ali nomegestrol acetatom, vendar manj učinkovito od zdravljenja s ciproteron acetatom.
English: Grounds for PRAC recommendation Whereas
Slovenian: Podlaga za priporočilo PRAC
English: Studies show considerable variability in their relative risk compared to non-use or other COCs and in their absolute risk for VTE.
Slovenian: Študije so pokazale znatne razlike v relativnem tveganju v primerjavi z neuporabo ali uporabo drugih kombiniranih peroralnih kontracepcijskih sredstev ter v absolutnem tveganju za VTE.
English: To assess venous and arterial thromboembolic effects from clinical studies with CPA/EE, only clinical studies that documented adverse events are discussed here.
Slovenian: Za oceno venskih in arterijskih trombemboličnih učinkov iz kliničnih študij s CPA/EE so v nadaljevanju obravnavane samo klinične študije, v katerih so zabeležili neželene učinke.
English: Concomitant medications
Slovenian: Sočasna uporaba drugih zdravil
English: None of the studies presents information on the fatality rate of VTE among CPA/EE users, except for the Seaman 2003 study stating that none of the 179 VTE events, including the 23 events among CPA/EE (2mg/0.035mg) exposed, was fatal.
Slovenian: Nobena predložena študija ne vsebuje podatkov o stopnji smrtnih primerov zaradi VTE med uporabnicami CPA/EE, z izjemo študije Seaman 2003, ki navaja, da se noben od 179 dogodkov VTE, vključno s 23 dogodki med uporabnicami CPA/EE (2 mg/0,035 mg), ni končal s smrtnim izidom.
English: The effects on hirsutism and seborrhoea have mainly been studied in the context of treatment of acne and/or polycystic ovary syndrome (PCOS).
Slovenian: Učinke na hirzutizem in seborejo so pretežno proučevali v povezavi z zdravljenjem aken in/ali sindroma policističnih jajčnikov (PCOS).
English: The PRAC considered that a Direct Healthcare Professional Communication (DHPC) was needed to communicate the outcome of the present review.
Slovenian: PRAC je menil, da je treba izdati neposredno obvestilo zdravstvenim delavcem (DHPC), da se jih seznani z izidom tega pregleda.
English: This is despite the fact that the study enrolment criteria overwhelmingly selected for patients in whom contraception would have been the original reason for consultation.
Slovenian: To se je zgodilo kljub temu, da so z merili za izbor sodelujočih v študiji želeli pretežno vključiti bolnice, pri katerih bi bila primarni razlog za obisk zdravnika kontracepcija.
English: In addition information in the section on circulatory disorders on the switch or restart was recommended by PRAC.
Slovenian: Poleg tega je PRAC priporočil, da se v poglavje o motnjah krvnega obtoka doda informacije o zamenjavi ali ponovnem začetku zdravljenja.
English: Epidemiological studies have suggested an association between the use of COCs in general and an increased risk of arterial thrombotic and thromboembolic diseases such as myocardial infarction, and of cerebrovascular accidents.
Slovenian: Epidemiološke študije kažejo na obstoj povezave med uporabo kombiniranih peroralnih kontracepcijskih sredstev na splošno in povečanim tveganjem za arterijske trombotične in trombembolične bolezni, kot je srčni infarkt, ter cerebrovaskularne dogodke.
English: Seborrhoea has mainly been evaluated in the context of acne.
Slovenian: Seborejo so pretežno ocenjevali v povezavi z aknami.
English: Age was reported for 877 of 968 (90.6%) patients.
Slovenian: O starosti so poročali za 877 od 968 (90,6 %) bolnic.
English: Benefit-risk balance
Slovenian: Razmerje med koristmi in tveganji
English: In addition the PRAC noted that these medicinal products have hormonal contraceptive effects and as such the concomitant use with another hormonal contraceptive is contraindicated.
Slovenian: Poleg tega je PRAC ugotovil, da imajo ta zdravila hormonske kontracepcijske učinke, zato je njihova sočasna uporaba z drugimi hormonskimi kontracepcijskimi sredstvi kontraindicirana.
English: The PRAC also recommended that the MAH should submit a full risk management plan (RMP) within 3 months following the decision of this procedure.
Slovenian: PRAC je priporočil tudi, da morajo imetniki dovoljenj za promet v 3 mesecih od sklepa v tem napotitvenem postopku predložiti celovit načrt za obvladovanje tveganja (RMP).
English: In study AI58, one patient on CPA/EE developed VTE.
Slovenian: V študiji AI58 se je VTE razvila pri eni bolnici, ki je prejemala CPA/EE.
English: Furthermore, the data do not systematically provide information on the medical history of the patient (e.g. history of acne or hyperandrogenic symptoms) or clinical findings as doctors tend to fill out the minimum mandatory information for the IMS.
Slovenian: Poleg tega iz njih ni mogoče sistematično pridobiti informacij o zdravstveni anamnezi bolnice (npr. anamneza aken ali simptomov hiperandrogenizacije) ali kliničnih ugotovitev, saj zdravniki IMS načeloma posredujejo zgolj najbolj osnovne obvezne informacije.
English: In these studies VTE risk among CPA/EE users was compared to the VTE risk of non-use as well as of various types of combined oral contraceptives (COCs).
Slovenian: V teh študijah so tveganje za VTE pri uporabnicah CPA/EE primerjali s tveganjem za VTE pri tistih, ki ne uporabljajo tovrstnih sredstev, in tistih, ki uporabljajo različne vrste kombiniranih peroralnih kontracepcijskih sredstev.
English: In a recent study (Lidegaard, 2012) the comparative analyses of the relative risk for thrombotic stroke and myocardial infarction between the various progestins, including levonorgestrel, and non-use are in the same magnitude and do not show differences between the various progestins.
Slovenian: V nedavni študiji (Lidegaard, 2012) so analize, v katerih so primerjali relativno tveganje za trombotično kap in srčni infarkt pri uporabi različnih progestinov, vključno z levonorgestrelom, in pri neuporabi, dale enake rezultate in niso pokazale razlik med različnimi progestini.
English: The overall global spontaneous reporting rate for all cases reporting any thrombotic /thromboembolic event is 1.3 per 100,000 women-years.
Slovenian: Skupna globalna stopnja spontanega poročanja za vse primere poročil o katerem koli trombotičnem/trombemboličnem dogodku je 1,3 na 100 000 žensk-let.
English: The PRAC also recommended further changes to the product information including that the need to continue treatment should be evaluated periodically knowing that the time to relief of symptoms is at least three months.
Slovenian: PRAC je priporočil tudi nadaljnje spremembe informacij o zdravilu, vključno z opozorilom, da je treba redno preverjati potrebo po nadaljnjem zdravljenju ob upoštevanju, da so za izboljšanje simptomov potrebni najmanj trije meseci;
English: The PRAC endorsed a Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review and to communicate to the healthcare professionals the updated indication and to highlight the risk of the thromboembolic events.
Slovenian: PRAC je odobril neposredno obvestilo zdravstvenim delavcem (Direct Healthcare Professional Communication - DHPC), da se jih seznani z izidom tega pregleda ter posodobljeno indikacijo in da se jih opozori na tveganje za trombembolične dogodke.
English: For the treatment of acne, the medicinal products should only be used after topical therapy or systemic antibiotic treatments have failed.
Slovenian: Za zdravljenje aken se lahko zdravila uporabljajo samo po neuspešnem lokalnem zdravljenju ali zdravljenju s sistemskimi antibiotiki.
English: Alternative treatments for moderate to severe acne are long-term antibiotics (topical or systemic), keratolytics and retinoids (topical or systemic, with known risks of teratogenicity and subject to a pregnancy prevention plan and regular liver function testing).
Slovenian: Zmerne do hude oblike aken je alternativno mogoče dolgoročno zdraviti z antibiotiki (lokalno ali sistemsko), keratolitiki in retinoidi (lokalno ali sistemsko, pri čemer obstaja tveganje za teratogenost, zato so potrebni ukrepi za preprečevanje nosečnosti ter redno preverjanje delovanja jeter).
English: These 968 cases comprise 7% of the total number of ADR reports received cumulatively through 30 Jan 2013 (n = 13,875 in total).
Slovenian: Teh 968 primerov predstavlja 7 % vseh poročil o neželenih učinkih zdravila, ki so jih kumulativno prejeli do 30. januarja 2013 (n = skupno 13 875).
English: In addition the PRAC stressed that these products should not be given concomitantly with other hormonal contraceptives and also that the need to continue treatment should be evaluated periodically knowing that the time to relief of symptoms is at least three months.
Slovenian: Prav tako je PRAC poudaril, da se tovrstna zdravila ne bi smela uporabljati sočasno z drugimi hormonskimi kontracepcijskimi sredstvi in da je treba redno preverjati potrebo po nadaljnjem zdravljenju ob upoštevanju, da so za izboljšanje simptomov potrebni najmanj trije meseci.
English: Compared with a corresponding reporting frequency ranging between 0.8 and 1.5 per 100,000 women-years during the previous six PSUR periods, there is no evidence of an overall increased reporting frequency of thrombotic /thromboembolic events.
Slovenian: Pri primerjavi s pogostostjo poročanja v prvih šestih poročevalnih obdobjih, ki je bila med 0,8 in 1,5 na 100 000 žensklet, ni opazno povečanje splošne pogostosti poročanja o trombotičnih/trombemboličnih dogodkih.
English: Of these 76 reports, 67 (88.2%) cases reported pulmonary embolism with or without reported DVT or unspecified thrombosis, 8 (10.5%) reports described cerebral events, and 1 (1.3%) reported events of dyspnoea, disseminated intravascular coagulation and circulatory disorder in context of multi-organ failure, acute hepatic failure, coma hepatic, bone marrow failure, fungal sepsis, pneumonia and histiocytosis haematophagic in a female patient with condition of alcohol abuse, acute myeloid leukaemia, polychemotherapy and antibiotics therapy.
Slovenian: Med temi 76 poročili je bilo 67 (88,2 %) primerov, pri katerih so poročali o pljučni emboliji z ali brez globoke venske tromboze ali neopredeljene tromboze, v 8 (10,5 %) poročilih so navedli možganske dogodke, v 1 (1,3 %) primeru pa so poročali o dispneji, diseminirani intravaskularni koagulaciji in motnjah krvnega obtoka v povezavi z odpovedjo več organov, akutni odpovedi jeter, hepatični komi, odpovedi kostnega mozga, glivični sepsi, pljučnici in hematofagni histiocitozi pri ženski, ki je čezmerno uživala alkohol, akutni mieloični levkemiji, polikemoterapiji in antibiotičnem zdravljenju.
English: According to the 2012 IMS data issued from 16 European countries, the percentage of CPA/EE (2mg/0.035mg) prescription in acne varies from 0 to 54% with a median at 9%.
Slovenian: Po podatkih IMS iz leta 2012, ki jih je izdalo 16 evropskih držav, je delež receptov za CPA/EE (2 mg/0,035 mg), predpisanih za akne, med 0 in 54 % z mediano 9 %.
English: In conclusion, the thromboembolic events are known adverse drug reactions associated with the use of estrogen-progestogen containing preparations.
Slovenian: Zaključiti je mogoče, da so trombembolični dogodki znani neželeni učinki, povezani z uporabo sredstev, ki vsebujejo estrogen in progestogen.
English: Early studies reported that the risk of (idiopathic) VTE in users of CPA/EE is greater in comparison to users of levonorgestrel-containing COC, or conventional COC respectively, with low estrogen (<50μg) (Vasilakis-Scaramozza & Jick 2001, Seaman et al, 2003).
Slovenian: Prve študije so pokazale, da je tveganje za (idiopatsko) VTE pri uporabnicah CPA/EE večje kot pri uporabnicah kombiniranih peroralnih kontracepcijskih sredstev, ki vsebujejo levonorgestrel, oziroma konvencionalnih kombiniranih peroralnih kontracepcijskih sredstev z nizko vsebnostjo estrogena (< 50 μg) (VasilakisScaramozza in Jick, 2001, Seaman et al., 2003).
English: This is the case in 54% of the 60% of prescriptions written by general practitioners (i.e. 32.4% of all prescriptions) and in 75% of the 36% of prescriptions written by gynaecologists (27.8% of all prescriptions), which implies that around 60% of all French prescriptions for CPA/EE (2mg/0.035mg) relate to contraception and therefore would be off-label use taking into account the indication only in acne in France.
Slovenian: Za ta namen je bilo izdanih 54 % od 60 % receptov, ki so jih predpisali splošni zdravniki (tj. 32,4 % vseh receptov), in 75 % od 36 % receptov, ki so jih predpisali ginekologi (27,8 % vseh receptov), kar kaže na to, da se okoli 60 % vseh receptov v Franciji za CPA/EE (2 mg/0,035 mg) predpiše v povezavi s kontracepcijo, kar se lahko šteje za uporabo, ki ni skladna z indikacijami, saj je v Franciji odobrena samo indikacija za akne.
English: Results indicated that after 6 month treatment the efficacy of CPA/EE (2mg/0.035mg) was superior and statistically significantly better than for LNG/EE.
Slovenian: Rezultati so pokazali, da je bila po 6 mesecih zdravljenja kombinacija CPA/EE (2 mg/0,035 mg) učinkovitejša in statistično znatno boljša od LNG/EE.
English: A recent published study comparing CPA/EE (2mg/0.035mg) and drospirenone/EE, and desogestrel/EE showed that after 6 months these medicinal products were equally efficacious but after 12 months CPA/EE (2mg/0.035mg) showed the strongest anti-androgenic effect, followed by drospirenone/EE, and desogestrel/EE as the weakest.
Slovenian: Nedavno objavljena študija, v kateri so primerjali CPA/EE (2 mg/0,035 mg) in drospirenon/EE ter dezogestrel/EE, je pokazala, da so bila po 6 mesecih ta zdravila enako učinkovita, po 12 mesecih pa so najmočnejši antiandrogeni učinek opazili pri kombinaciji CPA/EE (2 mg/0,035 mg), ki ji je sledila kombinacija drospirenon/EE, najšibkejši učinek pa pri kombinaciji dezogestrel/EE.
English: For the condition of alopecia in view of the very limited efficacy data, the PRAC concluded that the benefit-risk balance is not favourable and therefore these medicinal products should no longer be indicated in this therapeutic indication.
Slovenian: V zvezi z alopecijo je PRAC zaradi zelo omejenih podatkov o učinkovitosti zaključil, da razmerje med tveganji in koristmi ni pozitivno, zato tovrstna zdravila ne bi smela biti več indicirana za to terapevtsko indikacijo.
English: It has been shown that risk of VTE is highest during the first year a woman starts hormonal contraceptives or when she re-starts after a period of non-use of at least one month (Dinger et al,.
Slovenian: Dokazano je bilo, da je tveganje za VTE največje prvo leto po začetku jemanja hormonskih kontracepcijskih sredstev ali ko jih ženska začne ponovno jemati po več kot enomesečni prekinitvi (Dinger et al., 2007).
English: For the treatment of acne, topical therapies are applied for mild to moderate acne without hyperandrogenic state.
Slovenian: Za zdravljenje aken se pri blažjih do zmernih oblikah brez hiperandrogenizacije uporabljajo lokalna zdravila.
English: In total, 76 (7.9%) of 968 ADR reports with TE events reported fatal outcomes; 66 were medically confirmed and 10 were non-medically confirmed consumer reports.
Slovenian: Skupno so o neželenih učinkih s smrtnim izidom poročali v 76 (7,9 %) od 968 primerov s trombemboličnimi dogodki; 66 poročil potrošnikov je bilo zdravniško potrjenih, 10 pa jih ni bilo.
English: As of last PSUR (reporting period 01 Jun 2011 ─ 31 May 2012, DLP: 31 May 2012), the reporting frequency of all (arterial, venous and unspecified) thrombotic / thromboembolic events received during the reporting period was 1.3 per 100,000 womenyears.
Slovenian: Glede na zadnje poročilo (poročevalno obdobje od 1. junija 2011-31. maja 2012, zaključek vnosa podatkov: 31. maj 2012) je pogostost poročanja o vseh (arterijskih, venskih in neopredeljenih) trombotičnih/trombemboličnih dogodkih, zabeleženih med poročevalnim obdobjem, znašala 1,3 na 100 000 žensk-let.
English: In comparison with other medical treatment options, no clinical differences in hirsutism were detected when CPA/EE (2mg/0.035mg) was compared to other medicinal products (spironolactone, finasteride, GnRH analogues, ketoconazole).
Slovenian: Pri primerjavi z drugimi možnostmi zdravljenja niso opazili kliničnih razlik v zvezi s hirzutizmom, ko so CPA/EE (2 mg/0,035 mg) primerjali z drugimi zdravili (spironolaktonom, finasteridom, analogi GnRH, ketokonazolom).
English: CPA/EE (2mg/0.035mg) is often used in combination with cyproterone 10 mg (CPA 10 mg) in different daily doses to increase anti-androgenic effects.
Slovenian: Kombinacija CPA/EE (2 mg/0,035 mg) se pogosto uporablja v kombinaciji s ciproteronom 10 mg (CPA 10 mg) v različnih dnevnih odmerkih za povečanje antiandrogenih učinkov.
English: The overall global spontaneous reporting rate for all cases reporting any TE event at data lock point (DLP) 06 Mar 2013 is estimated as 1.5 per 100,000 women-years, 1.4 non-fatal TE reports per 100,000 women-years, and 0.1 fatal TE reports per 100,000 women-years with CPA/EE (91 fatal cases (8%) in total of 1143 cases).
Slovenian: Ocenjena skupna globalna stopnja spontanega poročanja za vse primere poročil o katerem koli trombemboličnem dogodku ob zaključku vnosa podatkov, 6. marca 2013, je 1,5 na 100 000 žensk-let, 1,4 poročila o TED brez smrtnega izida na 100 000 žensk-let in 0,1 poročila o TED s smrtnim izidom na 100 000 žensk-let s CPA/EE (91 smrtnih primerov (8 %) od skupno 1 143 primerov).
English: In July 2002, the Pharmacovigilance Working Party (PhVWP) discussed the increased venous thromboembolic (VTE) and arterial thromboembolic (ATE) risks and concluded that the use of cyproterone acetate/ethinylestradiol (2mg/0.035mg) should be restricted taking into account the thromboembolic events.
Slovenian: Julija 2002 je delovna skupina za farmakovigilanco (PhVWP) razpravljala o povečanem tveganju za vensko trombembolijo (VTE) in arterijsko trombembolijo (ATE) ter zaključila, da bi bilo treba uporabo zdravil, ki vsebujejo ciproteron acetat/etinilestradiol (2 mg/0,035 mg), ob upoštevanju trombemboličnih dogodkov omejiti.
English: The overall Pearl Index for CPA/EE (2mg/0.035mg) in a large clinical trial was 0.12 with an upper 95%-confidence limit of 0.44.
Slovenian: Skupni Pearlov indeks za CPA/EE (2 mg/0,035 mg) v obsežni klinični študiji je bil 0,12 z zgornjo mejo 95-odstotnega intervala zaupanja 0,44.
English: Non-fatal cases
Slovenian: Primeri brez smrtnega izida
English: Therefore retrieved cases of reporting TE adverse reactions from worldwide sources comprise also cases occurring in association with CPA/EE (2mg/0.035mg) in combination with CPA 10 mg (n = 48 [5%] cases in total).
Slovenian: Zato zbrani primeri poročil o TED iz virov z vsega sveta vključujejo tudi primere, ki so jih opazili v povezavi s CPA/EE (2 mg/0,035 mg) v kombinaciji s CPA 10 mg (n = skupno 48 [5 %] primerov).
English: CPA/EE (2mg/0.035mg) was prescribed according to the indication (i.e. androgenic symptoms) in 40% of cases and prescribed off-label in 31% (as a contraceptive or for menstrual irregularities).
Slovenian: CPA/EE (2 mg/0,035 mg) so za odobreno indikacijo (tj. simptome androgenizacije) predpisali v 40 % primerov, za neodobreno indikacijo pa v 31 % primerov (kot kontracepcijsko sredstvo ali za menstrualne motnje).
English: The effect of CPA/EE (2mg/0.035mg) on seborrhoeic symptoms, such as greasy skin and hair, starts after 3-4 cycles of treatment, and results are more pronounced with longer treatment.
Slovenian: Učinki CPA/EE (2 mg/0,035 mg) na simptome seboreje, kot sta mastna koža in lasje, se pojavijo po 3-4 ciklusih zdravljenja, rezultati pa so boljši pri dolgotrajnem zdravljenju.