FrancophonIA/ELRC3.0 huggingface dataset:
English: Evidence is primarily based on the adequate pearl indices obtained on EU/Canada study including an European population that allowed a 4-day tablet-free interval in case of 3 consecutive days of bleeding and/or spotting (Flex MB regimen).
Slovenian: Dokazi temeljijo predvsem na zadovoljivih Pearlovih indeksih iz EU/kanadske študije, v katero je bila vključena evropska populacija in ki je omogočala 4-dnevni premor brez jemanja tablet, če se med ciklom zdravljenja pojavijo krvavitev oziroma madeži, ki trajajo tri zaporedne dni (režim Flex MB).
English: This study A47505 was not assessed as in this study YAZ FlexMB was intended for the treatment of dysmenorrhoea instead of contraceptive efficacy) The following dose regimens were studied in the two pivotal 3-armed clinical Phase III studies: YAZ Flex Managed Bleeding (YAZ FlexMB) regimen; each cycle comprises 120 days of intended treatment followed by a 4-day tablet-free interval to induce withdrawal bleeding.
Slovenian: V obeh ključnih kliničnih študijah III. faze s tremi kraki (študija A47505 ni bila ocenjevana, saj je bila skupina YAZ FlexMB v tej študiji namesto kontracepcijski učinkovitosti namenjena zdravljenju dismenoreje) so bili preučeni naslednji režimi odmerjanja: režim Yaz s prilagodljivim upravljanjem krvavitev (Yaz FlexMB): vsak cikel obsega 120 dni načrtovanega zdravljenja in nato 4-dnevni premor brez jemanja tablet, ki sproži odtegnitveno krvavitev.
English: During days 25-120, the woman can decide to take tablets continuously up to a maximum of
Slovenian: Med 25. in 120. dnem se lahko ženska odloči, da bo jemala tablete neprekinjeno največ 120 dni.
English: Further, the total number of bleeding days per year decreased from 66 (YAZ 24+4) to 41-47 days (YAZ Stop & Go and YAZ Flex MB).
Slovenian: Poleg tega se je skupno število dni s krvavitvijo na leto zmanjšalo s 66 (YAZ 24+4) na 4147 (YAZ Stop & Go in YAZ Flex MB).
English: Whereas
Slovenian: n
English: The YAZ Stop & Go arm (in the US study only), the YAZ fixed extended arm (in the EU/Canada study) and the YAZ 24+4 arm (both studies) were included in the two studies to compare different bleeding patterns.
Slovenian: Kraki YAZ Stop & Go (samo v ameriški študiji), fiksni podaljšani YAZ (v EU/kanadski študiji) in YAZ 24+4 (v obeh študijah) so bili vključeni v študiji za primerjavo vzorcev krvavitev.
English: It is not expected that these slight differences in mean number of cycles (4.2 versus 4.6 breaks/year) and cycle length (73-78.2 versus 70.4 days of continuous tablet intake per treatment cycle) between YAZ Flex MB and YAZ Stop & Go will lead to a relevant difference in contraceptive efficacy.
Slovenian: Ne pričakuje se, da bi te majhne razlike med režimoma YAZ Flex MB in YAZ Stop & Go v povprečnem številu ciklov (4,2 v primerjavi s 4,6 premora/leto) in trajanju ciklov (73-78,2 v primerjavi s 70,4 dneva neprekinjenega jemanja tablet v vsakem ciklu zdravljenja) vodile do pomembne razlike v kontracepcijski učinkovitosti.
English: This treatment arm was included in both EU/Canada study and the US study and considered to be representative for the contraceptive efficacy of Yividually, as well as a comparison of the bleeding pattern with the bleeding pattern of YAZ 24+4 and other dose regimens; YAZ Stop & Go regimen; each cycle comprises 120 days of intended treatment followed by a 4day tablet-free interval to induce withdrawal bleeding.
Slovenian: Ta krak zdravljenja je bil vključen v EU/kanadsko študijo ter ameriško študijo in se šteje za reprezentativnega za kontracepcijsko učinkovitost zdravila Yvidually ter za primerjavo vzorca krvavitev z vzorcem krvavitev pri režimu YAZ 24+4 in drugih režimih odmerjanja; režim Yaz s prekinitvami (Stop & Go); vsak cikel obsega 120 dni načrtovanega zdravljenja in nato 4-dnevni premor brez jemanja tablet, ki sproži odtegnitveno krvavitev.
English: This arm was included in the US study for comparison of bleeding pattern with bleeding patterns of YAZ 24+4 and YAZ FlexMB; YAZ fixed extended regimen; 120 days of continuous tablet-taking (without any break) followed by a 4-day tablet-free interval.
Slovenian: Ta krak je bil vključen v ameriško študijo za primerjavo vzorca krvavitev z vzorcema krvavitev pri režimih YAZ 24+4 in YAZ FlexMB; fiksni podaljšani režim Yaz; 120 dni neprekinjenega jemanja tablet (brez premora), ki jim sledi 4-dnevni premor brez jemanja tablet.
English: Evidence is primarily based on the pearl indices obtained in an EU/Canada study that allowed a 4-day tablet-free interval in case of 3 consecutive days of bleeding and/or spotting (Flex MB regimen).
Slovenian: Dokazi temeljijo zlasti na Pearlovih indeksih iz EU/kanadske študije, ki je omogočala 4-dnevni premor brez jemanja tablet, če se med ciklom zdravljenja pojavijo krvavitev oziroma madeži, ki trajajo tri zaporedne dni (režim Flex MB).
English: the CHMP has recommended the granting of the marketing authorisation subject to recommended conditions with regard to the safe and effective use of the medicinal product as set out in Annex IV.
Slovenian: Odbor je presodil, da je razmerje koristi in tveganj zdravila Yvidually in povezana imena pri predlagani indikaciji in podaljšanem režimu odmerjanja ugodno; je odbor CHMP priporočil, da se dovoljenja za promet z zdravilom izda pod priporočenimi pogoji v zvezi z varno in učinkovito uporabo zdravila, navedenimi v Prilogi IV.
English: EU/CAN study A40196 (3 arms)
Slovenian: EU/kanadska študija A40196 (3 kraki)
English: The YAZ Stop & Go arm (in the US study only), the YAZ fixed extended arm (in the EU/Canada study) and the YAZ 24+4 arm (in both studies) were included in the two studies to compare different bleeding patterns, but were not powered to assess contraceptive efficacy.
Slovenian: Kraki YAZ Stop & Go (samo v ameriški študiji), fiksni podaljšani YAZ (v EU/kanadski študiji) in YAZ 24+4 (v obeh študijah) so bili vključeni v študiji za primerjavo vzorcev krvavitev, vendar niso imeli primerne moči za ocenjevanje kontracepcijske učinkovitosti.
English: The extended dose regimen of Yvidually has been developed based on the marketed combined oral contraceptive Yaz 24+4 for women who want to postpone the withdrawal bleeding by extending the intake cycle up to 120 days.
Slovenian: Podaljšani režim odmerjanja zdravila Yvidually je bil zasnovan na osnovi kombiniranega peroralnega kontracepcijskega sredstva Yaz 24+4, ki je že v prometu, in sicer za ženske, ki želijo odložiti odtegnitveno krvavitev s podaljšanjem cikla jemanja do 120 dni.
English: On the other hand, the number of withdrawal bleedings decreased from 12 times/year (YAZ 24+4) to 4.6 and 4.5 times/year (YAZ Stop & Go and YAZ Flex MB).
Slovenian: Na drugi strani se je število odtegnitvenih krvavitev zmanjšalo z 12-krat/leto (YAZ 24+4) na 4,6krat/leto pri režimu YAZ Stop & Go in 4,5-krat/leto pri režimu YAZ Flex MB.
English: In summary, the data have demonstrated that compared to YAZ 24+4, the number of withdrawal episodes decreases as well as the total number of bleeding days over a period of 1 year, which is the aim of this product.
Slovenian: Skratka, podatki so pokazali, da se število odtegnitvenih epizod in skupno število dni s krvavitvijo v enem letu v primerjavi z režimom YAZ 24+4 zmanjšuje, kar je cilj zdravila.
English: It is concluded that contraceptive efficacy of Yvidually has been sufficiently demonstrated for the proposed dosing regimen of Yvidually that allows the woman to decide herself to take a 4-day tabletfree interval or not during the flexible phase.
Slovenian: Zaključeno je bilo, da je bila kontracepcijska učinkovitost predlaganega režima odmerjanja zdravila Yvidually, ki omogoča, da se med ženska med prilagodljivo fazo odloči za 4-dnevno obdobje brez jemanja tablet ali ne, zadostno dokazana.
English: Additionally, a third study (A47505) was conducted in women with moderate to severe primary dysmenorrhea and is presented as a supportive clinical trial regarding information on bleeding pattern during use of the extended dose regimen.
Slovenian: Dodatna, tretja študija (A47505) je bila opravljena pri ženskah z zmerno do hudo primarno dismenorejo.
English: YAZ flex MB in 880 women for 2 years (contraceptive efficacy + bleeding)
Slovenian: YAZ Flex MB pri 880 ženskah, trajanje 2 leti (kontracepcijska učinkovitost + krvavitev) Fiksni podaljšani režim YAZ pri 200 ženskah, trajanje 1 leto (krvavitev)
English: In summary, Yvidually has been developed for women who want to postpone the monthly withdrawal bleeding, occurring with the marketed combined oral contraceptive YAZ 24+4, by extending the intake cycle up to 120 days.
Slovenian: Skratka, zdravilo Yvidually je bilo zasnovano za ženske, ki želijo odložiti mesečno odtegnitveno krvavitev, do katere pride pri uporabi kombiniranega peroralnega kontraceptiva YAZ 24+4, ki je v prometu, s podaljšanjem cikla jemanja zdravila do 120 dni.
English: Additionally, as presented by the applicant, only slight differences in the number of cycles (i.e 4-day breaks) and mean cycle length (number of days of continuous intake of tablets) between YAZ Flex MB variant and the YAZ Stop & Go regimen were observed (see tables below).
Slovenian: Predlagatelj je tudi pokazal, da med režimoma YAZ Flex MB in YAZ Stop & Go obstajajo le majhne razlike v številu ciklov (tj. 4-dnevnih premorov) in povprečnem trajanju cikla (številu dni neprekinjenega jemanja tablet) (glejte spodnji preglednici).
English: Compared to the conventional YAZ 24+4 dosing regimen (6 days/year), the number of days of intracyclic bleeding was comparable in the YAZ Flex MB regimen (5 days/year), but more frequent in the YAZ Stop & Go (14.8 days/year).
Slovenian: Število dni krvavitve med cikli je bilo v primerjavi z običajnim režimom odmerjanja YAZ 24+4 (6 dni/leto) pri režimu YAZ Flex MB (5 dni/leto) primerljivo, pri režimu YAZ Stop & Go (14,8 dneva/leto) pa večje.
English: Irrespective of bleeding and/or spotting, women are allowed to schedule their withdrawal bleeding (i.e. the 4-day tablet-free interval) at any time between days 25 and 120 of the treatment cycle.
Slovenian: Ženskam je dovoljeno načrtovati odtegnitveno krvavitev (tj. 4-dnevni premor brez jemanja tablet) kadar koli med 25. in 120. dnem cikla zdravljenja, ne glede na krvavitve oziroma madeže.
English: Yvidually has been developed for women who want to postpone the monthly withdrawal bleeding, occurring with the marketed combined oral contraceptive YAZ 24+4 by extending the intake cycle up to 120 days.
Slovenian: Zdravilo Yvidually je bilo zasnovano za ženske, ki želijo odložiti mesečno odtegnitveno krvavitev, do katere pride pri uporabi kombiniranega peroralnega kontraceptiva YAZ 24+4, ki je v prometu, s podaljšanjem cikla jemanja zdravila do 120 dni.
English: The data have adequately demonstrated that compared to YAZ 24+4 (conventional regimen), the number of withdrawal episodes decreases as well as the total number of bleeding days over a period of 1 year, which is the aim of this product.
Slovenian: Podatki so zadostno dokazali, da se število odtegnitvenih epizod in skupno število dni s krvavitvijo v enem letu v primerjavi z režimom YAZ 24+4 (običajni režim) zmanjša, kar je cilj tega zdravila.
English: YAZ Flex MB in 1400 women for 1 year (contraceptive efficacy + bleeding)
Slovenian: YAZ Flex MB pri 1 400 ženskah, trajanje 1 leto (kontracepcijska učinkovitost + krvavitev) YAZ Stop & Go pri 200 ženskah, trajanje 1 leto (krvavitev)
English: This arm was included in the EU/Canada study in order to compare with bleeding patterns of the other treatment arms; YAZ 24+4 (YAZ) regimen; 24 days of continuous tablet-taking followed by a 4-day tablet-free interval (regimen authorised in Europe) included in both studies in order to compare bleeding patterns; Except for the YAZ fixed extended regimen, the minimum treatment period between tablet-free intervals (i.e. minimum cycle length) in each regimen was 24 days (to maintain contraceptive efficacy).
Slovenian: Ta krak je bil vključen v EU/kanadsko študijo za primerjavo vzorcev krvavitev z drugimi kraki zdravljenja; režim YAZ 24+4 (YAZ); 24 dni neprekinjenega jemanja tablet, ki jim sledi 4-dnevni premor brez jemanja tablet (režim, odobren v Evropi), je bilo vključenih v obe študiji za primerjavo vzorcev krvavitev.
English: YAZ fixed extended in 200 women for 1 year (bleeding) YAZ 24+4 in 200 women for 1 year (bleeding)
Slovenian: YAZ 24+4 pri 200 ženskah, trajanje 1 leto (krvavitev)
English: Higher PIs were obtained in the other pivotal study A48294 that was carried out in the US. Higher PIs have also been observed for other COCs in studies performed in the US, which is probably related to problems with compliance.
Slovenian: V študijah, opravljenih v ZDA, so ugotovili višje Pearlove indekse tudi za druge kombinirane peroralne kontraceptive, kar je verjetno povezano s težavami z upoštevanjem navodil za jemanje zdravil.
English: YAZ fixed Extended
Slovenian: YAZ Stop & Go fiksni podaljšani YAZ
English: No significant differences in number of cycles and mean cycle length were observed when a 4-day tablet-free interval was allowed irrespective of bleeding and/or spotting (Stop & Go regimen).
Slovenian: Ko je bil dovoljen 4-dnevni premor brez jemanja tablet ne glede na krvavitve oziroma madeže (režim Stop & Go), ni bilo pomembnih razlik v številu ciklov in povprečnem trajanju cikla.
English: No significant differences in number of cycles and mean cycle length were observed when a 4-day tablet-free interval was recommended irrespective of bleeding and/or spotting (Stop & Go regimen).
Slovenian: Ko je bil priporočen 4-dnevni premor brez jemanja tablet ne glede na krvavitve oziroma madeže (režim Stop & Go), ni bilo pomembnih razlik v številu ciklov in povprečnem trajanju cikla.
English: During days 25- 120, she may schedule a 4-day tablet-free interval (induction of withdrawal bleeding) in the event of 3 consecutive days of bleeding.
Slovenian: V primeru treh zaporednih dni krvavitve se lahko ženska med 25. in 120. dnem odloči za 4-dnevno obdobje brez jemanja tablet (za sprožitev odtegnitvene krvavitve).
English: It is known and described in the SmPCs of all COCs that postponing a withdrawal bleed will introduce higher risk of intracyclic bleeding in most women.
Slovenian: Znano je, da prestavljanje odtegnitvene krvavitve poveča tveganje krvavitve pri večini žensk, kar je tudi opisano v povzetkih glavnih značilnosti zdravila vseh kombiniranih peroralnih kontracepcijskih sredstev.
English: Therefore it should not be used in this age group.
Slovenian: Zato se ga v tej starostni skupini ne sme uporabljati.
English: Results from clinical studies in patients
Slovenian: Rezultati kliničnih raziskav pri bolnikih
English: Specific studies have not been conducted in elderly patients.
Slovenian: Specifičnih raziskav pri starejših bolnikih ni bilo.
English: Data from four major trials are presented here.
Slovenian: Tukaj so prikazani podatki iz štirih velikih raziskav.
English: Treatment should be intermittent and not continuous.
Slovenian: Zdravljenje mora biti intermitentno, ne neprekinjeno.
English: Protopy can be used for short term and intermittent long term treatment.
Slovenian: Protopy se lahko uporablja za kratkoročno in intermitentno dolgoročno zdravljenje.
English: In case of live attenuated vaccination, this period should be extended to 28 days or the use of alternative vaccines should be considered.
Slovenian: V primeru živih atenuiranih cepiv je treba ta čas podaljšati na 28 dni ali razmisliti o drugačnem cepivu.
English: However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment.
Slovenian: Vendar pa klinične izkušnje pri tej populaciji bolnikov ne kažejo potrebe po prilagajanju odmerka.
English: Frequencies are defined as very common (> 1/10), common (> 1/100, < 1/10) and uncommon (> 1/1,000, < 1/100).
Slovenian: Opredelitev pogostnosti: zelo pogosti (> 1/10), pogosti (> 1/100, < 1/10) in občasni (> 1/1.000, < 1/100).
English: Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AX14
Slovenian: Farmakoterapevtska skupina: Druga dermatološka zdravila, oznaka ATC: D11AX14
English: If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered.
Slovenian: Če po dveh tednih zdravljenja ni znakov izboljšanja, je treba pretehtati druge možnosti zdravljenja.
English: Before applying Protopy after a bath or shower, be sure your skin is completely dry.
Slovenian: Preden Protopy nanesete po kopeli ali prhanju, se prepričajte, da je koža popolnoma suha.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28/02/2002
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 28/02/2002
English: Date of renewal: 20/11/2006
Slovenian: Datum podaljšanja dovoljenja za promet: 20/11/2006
English: The majority of these cases related to infections (skin, respiratory tract, tooth) and resolved with appropriate antibiotic therapy.
Slovenian: Večina teh primerov je bila povezana z okužbami (koža, dihala, zobje) in je izginila po ustreznem antibiotičnem zdravljenju.
English: Apply Protopy twice a day for up to three weeks, once in the morning and once in the evening.
Slovenian: Protopy do tri tedne uporabljajte dvakrat na dan, enkrat zjutraj in enkrat zvečer.
English: The safety of using Protopy for a long time is not known.
Slovenian: Varnost dolgotrajne uporabe Protopya ni znana.
English: What Protopy is and what it is used for 2.
Slovenian: Kaj je zdravilo Protopy in za kaj ga uporabljamo 2.
English: In the presence of these infections, the balance of risks and benefits associated with Protopy use should be evaluated.
Slovenian: V primeru teh okužb je treba pretehtati tveganja in koristi uporabe Protopya.
English: The efficacy and safety of Protopy was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.
Slovenian: Učinkovitost in varnost Protopya so ocenili pri več kot 13.500 bolnikih, zdravljenih z mazilom s takrolimusom v kliničnih raziskavah od I. do III. faze.
English: Improvement ≥ 90% in Physician's Global Evaluation § lower values = greater improvement
Slovenian: Izboljšanje za ≥ 90% po zdravniški celotni oceni § nižje vrednosti = večje izboljšanje
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu.
English: The effect of treatment with Protopy on the developing immune system in children, especially
Slovenian: Učinek zdravljenja s Protopyom na razvijajoči se imunski sistem pri otrocih, posebno pri mlajših,
English: Manufacturer: Astellas Ireland Co. Ltd., Killorglin, County Kerry, Ireland.
Slovenian: Izdelovalec: Astellas Ireland Co. Ltd., Killorglin, County Kerry, Irska.
English: Because of the potential risk of vaccination failure, vaccination should be administered prior to commencement of treatment, or during a treatment-free interval with a period of 14 days between the last application of Protopy and the vaccination.
Slovenian: Zaradi možnega tveganja za neuspeh cepljenja je treba cepivo aplicirati pred začetkom zdravljenja ali v obdobju, ko zdravljenje ne poteka; pri tem mora med zadnjo uporabo Protopya in cepljenjem miniti 14 dni.
English: Protopy ointment should not be applied under occlusion (see section 4.4).
Slovenian: Protopy mazilo se ne sme uporabiti pod okluzijo (glejte poglavje 4.4).
English: Generally, improvement is seen within one week of starting treatment.
Slovenian: Izboljšanje se praviloma pojavi v enem tednu po začetku zdravljenja.
English: Avoid using the ointment inside your nose or mouth or in your eyes.
Slovenian: Mazila ne uporabljajte v nosu, ustih ali na očeh.
English: Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed.
Slovenian: Velikosti pakiranj: 10 g, 30 g in 60 g. Na trgu ni vseh navedenih pakiranj.
English: If you spend time outdoors after applying Protopy, use a sunscreen and wear loose fitting clothing that protects the skin from the sun.
Slovenian: Če greste po uporabi Protopya na prosto, uporabite sredstvo za sončenje in oblecite ohlapna oblačila, ki kožo varujejo pred soncem.
English: These symptoms are usually mild to moderate and generally go away within one week of using Protopy.
Slovenian: Ti simptomi so ponavadi blagi do zmerni in praviloma minejo v enem tednu uporabe Protopya.
English: Also speak to your doctor before using Protopy if you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
Slovenian: Prav tako se pred uporabo Protopya posvetujte z zdravnikom, če imate kakšen malignom (tumor) na koži ali imate zaradi kakršnegakoli razloga oslabljen imunski sistem (ste imunsko oslabeli).
English: If you forget to use Protopy
Slovenian: Če ste pozabili uporabiti zdravilo Protopy
English: Table 2 Efficacy at week 3
Slovenian: Tabela 2 Učinkovitost po 3 tednih
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti
English: Don't use Protopy if you are pregnant or breast-feeding.
Slovenian: Ne uporabljajte Protopya, če ste noseči ali če dojite.
English: You may use moisturising creams and lotions during treatment with Protopy but these products should not be used within two hours of applying Protopy.
Slovenian: Med zdravljenjem s Protopyom lahko uporabljate vlažilne kreme in losjone, vendar teh izdelkov ne smete nanesti v razmiku manj kot dve uri od uporabe Protopya.
English: Taking or using other medicines and cosmetics Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Jemanje ali uporaba drugih zdravil in kozmetičnih sredstev Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo,
English: At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated.
Slovenian: Ob prvih znakih recidiva (ponovitve) simptomov bolezni je treba zdravljenje znova začeti.
English: The use of Protopy at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.
Slovenian: Hkratna uporaba Protopya z drugimi pripravki, ki se uporabljajo na koži, in med jemanjem peroralnih kortikosteroidov (npr. kortizona) ali zdravil, ki vplivajo na imunski sistem, ni raziskana.
English: In the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopy should be considered.
Slovenian: V odsotnosti jasne etiologije za limfadenopatijo ali v navzočnosti akutne infekcijske mononukleoze je treba pretehtati opustitev Protopya.
English: As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (> 98.8%) to plasma proteins is considered not to be clinically relevant.
Slovenian: Sistemska izpostavljenost je med uporabo mazila s takrolimusom majhna, zato velika vezava takrolimusa (> 98,8%) na beljakovine v plazmi ne velja za klinično pomembno.
English: As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.
Slovenian: V raziskavah klinične učinkovitosti so zdravljenje prekinili abruptno, zato ni podatkov, ali bi zmanjševanje odmerka zmanjšalo delež ponovitev.
English: The changes were caused by high systemic exposure of rodents resulting from high transdermal absorption of tacrolimus.
Slovenian: Spremembe je povzročila velika sistemska izpostavljenost glodalcev, ki je bila posledica velike transdermalne absorpcije takrolimusa.