FrancophonIA/ELRC3.0 huggingface dataset:
English: Linco-Spectin 100 is a powder for oral solution containing 33.3 g lincomycin (as lincomycin hydrochloride) and 66.7 g spectinomycin (as spectinomycin sulphate) per 150 g pack.
Slovenian: Zdravilo Linco-Spectin 100 je prašek za peroralno raztopino, ki vsebuje 33,3 g linkomicina (v obliki linkomicinijevega hidroklorida) in 66,7 g spektinomicina (v obliki spektinomicinijevega sulfata) na pakiranje 150 g. Linkomicin je linkozamidni antibiotik, zelo podoben makrolidnim antibiotikom in streptograminom B. Zavira sintezo beljakovin, tako da se veže na ribosomsko podenoto bakterije 50S.
English: This amounts to 75 mg powder/kg bw/day for 7 days.
Slovenian: To znese 75 mg praška na kg telesne teže na dan, za čas zdravljenja 7 dni.
English: Lincomycin and spectinomycin were shown to be more effective than each individual substance.
Slovenian: Pokazali so, da je kombinacija linkomicina in spektinomicina učinkovitejša kot njuni monoterapiji.
English: A single oral dose of 10 mg/kg body weight was administered to pigs to determine the bioavailability.
Slovenian: Za določitev biološke razpoložljivosti zdravila so prašičem dali enkratni peroralni odmerek 10 mg/kg telesne teže.
English: Pharmacotherapeutic group: antibacterials for systemic use, lincomycin combinations.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, kombinacije linkomicina oznaka ATC vet: QJ01FF52
English: For use in drinking water.
Slovenian: ZDRAVILA Za uporabo v vodi za pitje.
English: Ingestion by these species may result in severe gastrointestinal effects.
Slovenian: Zaužitje lahko pri teh živalskih vrstah povzroči resne učinke na želodec in črevesje.
English: To determine the volume of dilution (in litres of drinking water) required for 150 g of the veterinary medicinal product, use the following formula:
Slovenian: Piščanci: Za določitev volumna raztopine (v litrih vode za pitje), ki je potreben za 150 g zdravila za uporabo v veterinarski medicini, uporabite naslednjo formulo: Volumen (L) za 150 g zdravila za uporabo v veterinarski medicini
English: Oral powder for use in drinking water
Slovenian: Peroralni prašek za uporabo v vodi za pitje
English: Pigs: for administration via drinking water.
Slovenian: Prašiči: za dajanje v vodo za pitje.
English: 2,500 L of drinking water
Slovenian: 2500 L vode za pitje
English: Lincomycin (as lincomycin hydrochloride)
Slovenian: linkomicin (kot linkomicinijev klorid)
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) V primeru prevelikega odmerjanja se pri prašičih lahko opazi spremenjeno konzistenco blata (mehko blato in/ali drisko).
English: This amounts to 15 mg powder/kg bw/day for 7 days.
Slovenian: To znese 15 mg praška na kg telesne teže na dan, za čas zdravljenja 7 dni.
English: MARKETING AUTHORISATION HOLDER To be completed nationally.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Podatke je treba dopolniti v posameznih državah.
English: In the event of overdose in pigs, a change in the consistency of the faeces (soft faeces and/or diarrhoea) may be observed.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) V primeru prevelikega odmerjanja se pri prašičih lahko opazi spremenjeno konzistenco blata (mehko blato in/ali drisko).
English: Therefore, even though no evolution over time appears from the provided literature data, it cannot be excluded that the results obtained in the old clinical studies conducted at the time of product development do not reflect clinical efficacy in modern outbreaks of swine dysentery.
Slovenian: Zato ni mogoče izključiti, da rezultati iz starih kliničnih študij, izvedenih v času razvoja zdravila, ne odražajo klinične učinkovitosti pri sodobnih izbruhih prašičje dizenterije, čeprav predloženi podatki iz literature ne kažejo na evolucijo v času.
English: Pharmacokinetic particulars
Slovenian: Farmakokinetični podatki
English: The combination lincomycin-spectinomycin was also shown to be superior to each individual active substance.
Slovenian: Pokazali so tudi, da je kombinacija linkomicina in spektinomicina boljša v primerjavi s posameznima zdravilnima učinkovinama.
English: Poultry, not eggs for human consumptio n oral
Slovenian: Peroralni prašek Prašiči Perutnina, jajca niso za prehrano ljudi
English: The presence of the disease in the flock must be established before the product is used.
Slovenian: Pred uporabo zdravila je treba potrditi prisotnost bolezni v čredi.
English: Soluble Powder Pigs Poultry (nonlayers)
Slovenian: Topni prašek Prašiči in perutnina (nenesnice)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottles containing 150 g or 1.5 kg and tub containing 4.5 kg
Slovenian: Plastenke s 150 g ali 1,5 kg in vedro s 4,5 kg praška
English: Although the mechanism of action at the systemic level of spectinomycin administered orally is not elucidated, its clinical benefit and the benefit of the combination seems to be demonstrated in several older laboratory challenge studies; however, the dosing regimens applied in these studies can only be estimated and likely range from the harmonised dose of 50 mg/kg bw/day to at least the highest approved dose of 150 mg/kg bw/day.
Slovenian: Vendar je mogoče režime odmerjanja, uporabljene v teh študijah, samo oceniti: njihov razpon je verjetno od usklajenega odmerka 50 mg/kg telesne mase/dan in vsaj do največjega odobrenega odmerka 150 mg/kg telesne mase/dan.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem.
English: Spectinomycin
Slovenian: Spektinomicin
English: The spectinomycin exhibits little tendency to protein binding and is poorly liposoluble.
Slovenian: Spektinomicin se v majhni meri veže na plazemske beljakovine in je slabo topen v maščobah.
English: Pigs Chicken (broiler, pullet) Turkey
Slovenian: Peroralni prašek Prašiči Perutnina (brojlerji, kokoši in purani)
English: Meat and offal: Zero days.
Slovenian: Meso in organi: nič dni.
English: To ensure a correct dosage and avoid underdosing, mean body weights in the group of animals and daily water consumption should be determined as accurately as possible.
Slovenian: Čim natančneje je treba določiti povprečno telesno težo živali v čredi/jati in količino dnevno popite vode, da se zagotovi pravilen odmerek in da se izognemo premajhnemu odmerjanju.
English: Chickens
Slovenian: Ciper
English: - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: 0.2 L/kg bw/day
Slovenian: 0.2 L/kg telesne teže/dan
English: 1,000 L of drinking water
Slovenian: 1000 L vode za pitje
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja)
English: Marketing authorisation holder and manufacturer responsible for batch release: To be completed nationally
Slovenian: Izdelovalec, odgovoren za sproščanje serije:
English: 1,500 L of drinking water
Slovenian: 1500 L vode za pitje
English: 0.1 L/kg bw/day
Slovenian: 0.1 L/kg telesne teže/dan
English: Powder for solution in drinking water
Slovenian: Prašek za raztopino v vodi za pitje
English: 2,000 L of drinking water
Slovenian: 2000 L vode za pitje
English: Soluble powder Pigs Chickens
Slovenian: Topni prašek Prašiči Piščanci
English: EXPIRY DATE
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP
English: 0.25 L/kg bw/day
Slovenian: 0.25 L/kg telesne teže/dan
English: Poultryhens, chickens and turkeys
Slovenian: Prašiči Perutninakokoši, piščanci in purani
English: Oral Powder
Slovenian: Prašek za peroralno raztopino
English: Sodium benzoate Lactose
Slovenian: Seznam pomožnih snovi Natrijev benzoat Laktoza monohidrat
English: 0.15 L/kg bw/day
Slovenian: 0.15 L/kg telesne teže/dan
English: Manufacturer responsible for batch release: To be completed nationally
Slovenian: Imetnik dovoljenja za promet z zdravilom: Podatke je treba dopolniti v posameznih državah
English: ATCvet code: QJ01FF52.
Slovenian: FARMACEVTSKI PODATKI 6.1.
English: Chickens:
Slovenian: Piščanci:
English: Water consumption
Slovenian: Popita voda
English: Powder for oral solution.
Slovenian: Prašek za peroralno raztopino.
English: Ringaskiddy,
Slovenian: • odmerjanje;
English: Pigs Chickens
Slovenian: Prašiči Piščanci
English: Zoetis BV
Slovenian: 4.11 Karenca
English: MA (EU) number (Invented) name
Slovenian: Izmišljeno ime
English: No additional modifications were made by the CHMP.
Slovenian: Odbor CHMP ni sprejel nobenih dodatnih sprememb.
English: Risk management plan
Slovenian: Načrt za obvladovanje tveganja
English: Bleeding pattern
Slovenian: Vzorec krvavitev
English: Seasonique is authorised in some countries outside the European Union (EU).
Slovenian: Zdravilo Seasonique je odobreno v nekaterih državah zunaj Evropske unije.
English: Contraceptive efficacy
Slovenian: Kontracepcijska učinkovitost
English: Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Slovenian: Nemčija je menila, da bi lahko odobritev dovoljenja za promet pomenila resno tveganje za javno zdravje;
English: Overall summary of the scientific evaluation of Seasonique and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Seasonique in povezanih imen (glejte Prilogo I)
English: Critical evaluation
Slovenian: Kritično vrednotenje
English: Grounds for positive opinion
Slovenian: Podlaga za pozitivno mnenje
English: • The Committee considered the notification of the referral triggered by France under Article 29(4) of Directive 2001/83/EC.
Slovenian: • odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Francija skladno s členom 29(4) Direktive 2001/83/ES.
English: Both active substances are already authorised in this combination, at this dosage and at a lower dosage (LGN 100 µg/ EE 20 µg).
Slovenian: Obe zdravilni učinkovini sta že odobreni v tej kombinaciji, tem odmerku in manjšem odmerku (LGN 100 µg/EE 20 µg).
English: For the analysis, this period was split in two 28-day and a 35-day periods.
Slovenian: Za namene analize so to obdobje razdelili na dve 28─dnevni in eno 35─dnevno obdobje.
English: A risk management plan was submitted and agreed upon during the preceding Decentralised Procedure on Seasonique.
Slovenian: Načrt za obvladovanje tveganja je bil predložen in potrjen med predhodnim decentraliziranim postopkom za zdravilo Seasonique.
English: The decentralised marketing authorisation application was submitted under Article 28(3) of Directive 2001/83/EC in accordance with Article 10b of Directive 2001/83/EC.
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom po decentraliziranem postopku je bila predložena po členu 28(3) Direktive 2001/83/ES v skladu s členom 10b Direktive 2001/83/ES.
English: Indeed the LNG 150 µg/ EE 30 µg hormonal combination has been approved as a contraceptive in the EU for over 35 years and its efficacy is well documented.
Slovenian: Hormonska kombinacija LNG 150 µg/EE 30 µg je v EU kot kontracepcijsko sredstvo odobrena že več kot 35 let, njena učinkovitost pa je dobro dokumentirana.
English: The CHMP requested advice from the Biostatistics Working Party (BSWP) on the validity of this method in the present case.
Slovenian: Odbor CHMP je zaprosil delovno skupino za biostatistiko (BSWP) za mnenje o ustreznosti te metode v zadevnem primeru.
English: The overall treatment compliance for all treated patients was ≥ 97% in the pivotal study and ≥ 98% in the supportive study.
Slovenian: Skupni delež zdravljenih bolnic, ki so se držale navodil za zdravljenje, je v ključni študiji znašal ≥ 97 %, v podporni študiji pa ≥ 98 %.
English: Scientific conclusions and grounds for positive opinion presented by the European Medicines Agency
Slovenian: Znanstveni zaključki in podlaga za pozitivno mnenje, ki jih je predstavila
English: The proposed indication for Seasonique was “oral contraception”.
Slovenian: Predlagana indikacija za zdravilo Seasonique je bila „peroralna kontracepcija“.
English: The decentralised procedure was closed on day 210, with most of the Concerned Member States (CMS) agreeing with the conclusions of the RMS except Germany which raised a potential serious risk to public health.
Slovenian: Decentralizirani postopek se je končal na 210. dan, ko je večina zadevnih držav članic soglašala z zaključki referenčne države članice, z izjemo Nemčije, ki je izrazila zaskrbljenost zaradi možnega resnega tveganja za javno zdravje.
English: Thus, the major concern raised by Germany could not be solved during the CMDh referral and the issue was therefore referred to the CHMP.
Slovenian: Glavnega zadržka, ki ga je izpostavila Nemčija, tako med napotitvenim postopkom skupine CMDh ni bilo mogoče razrešiti, zato je bila zadeva napotena na odbor CHMP.
English: The results obtained in clinical trials with Seasonique are further supported by post-marketing data.
Slovenian: Rezultate, dobljene v kliničnih preskušanjih zdravila Seasonique, podpirajo tudi podatki iz obdobja trženja.
English: Hence the applicant was asked to conduct additional analyses of the bleeding pattern based on three extrapolation rules to include women who prematurely discontinued treatment and to extrapolate those data to the total planned study duration of PSE-302 of one year.
Slovenian: Od predlagatelja so zato zahtevali, da opravi dodatne analize vzorca krvavitev z upoštevanjem treh pravil za ekstrapolacijo, tako da se bodo vključile ženske, ki so predčasno prekinile zdravljenje, in se bodo ti podatki ekstrapolirali v celotno načrtovano enoletno trajanje študije PSE─302.
English: Due to the low estrogen content, the preparation belongs to the so-called low-dose combined oral contraceptives (COCs).
Slovenian: Zaradi majhne vsebnosti estrogena zdravilo spada med tako imenovane nizkoodmerne kombinirane peroralne kontraceptive.
English: However in the DP384/30 arm of study PSE-301, for 3 out of the 9 pregnancies included in the analysis as ‘on-treatment', drug accountability could not be performed; indeed, based on the available data, these pregnancies might be considered ‘off-treatment'.
Slovenian: Vendar v skupini DP3─84/30 študije PSE─301 pri 3 od 9 nosečnosti, vključenih v analizo kot „med zdravljenjem“, ni bilo mogoče preveriti odgovornosti zdravila; na podlagi razpoložljivih podatkov bi bile lahko te nosečnosti obravnavane kot „brez zdravljenja“.
English: Study PSE-302 included a limited number of cycles of exposure and was not designed for PI evaluation.
Slovenian: Študija PSE─302 je vključila omejeno število ciklov izpostavljenosti in ni bila načrtovana za oceno Pearlovega indeksa.
English: the CHMP has recommended the granting of the marketing authorisation(s) for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Seasonique and associated names (see Annex I).
Slovenian: je odbor CHMP priporočil odobritev dovoljenj(a) za promet z zdravilom, za katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, kot je navedeno v Prilogi III za zdravilo Seasonique in povezana imena (glejte Prilogo I).
English: Overall benefit-risk balance
Slovenian: Splošno razmerje med tveganji in koristmi
English: The CHMP supported the position of the BSWP, which considered that the bootstrap method is generally inappropriate for calculating confidence intervals for a PI; even more so in this example where it was not pre-specified, and was employed only after negative results were seen for the more conventional analysis.
Slovenian: Odbor CHMP je podprl stališče skupine, ki je menila, da metoda zankanja običajno ni primerna za izračun intervalov zaupanja za Pearlov indeks, kar še bolj velja v tem primeru, ko ni bila vnaprej opredeljena, temveč so jo uporabili šele potem, ko so z običajnejšo analizo dobili negativne rezultate.
English: Some CHMP members considered that this publication is not acceptable as proof of contraceptive efficacy of extended cycle regimens as this type of study is prone to various kinds of confounders (duration of use of the different COCs, intention of pregnancy, use for other reasons than contraception).
Slovenian: Nekateri člani odbora CHMP so menili, da ta publikacija ni sprejemljiva kot dokaz o kontracepcijski učinkovitosti režimov s podaljšanim ciklusom, saj lahko na rezultate tovrstne študije vplivajo številni različni dejavniki (trajanje uporabe različnih kombiniranih peroralnih kontraceptivov, želja po zanositvi, uporaba zaradi razlogov, ki niso povezani s kontracepcijo).
English: In line with these findings, the laboratory results demonstrated that the unscheduled bleeding/spotting profile with Seasonique did not lead to clinically significant changes.
Slovenian: Skladno s temi ugotovitvami so rezultati laboratorijskih preiskav pokazali, da profil nepredvidenih krvavitev/krvavkastega izcedka pri uporabi zdravila Seasonique ni povzročil klinično pomembnih sprememb.
English: The clinical development program for Seasonique included two phase III randomised clinical trials, the pivotal study PSE-301 and a supportive study, PSE-302, specifically designed to assess endometrial biopsy results, which were performed in the United States.
Slovenian: Program kliničnega razvoja zdravila Seasonique je vključeval dve randomizirani klinični preskušanji III. faze, in sicer ključno študijo PSE─301 ter podporno študijo PSE─302, ki sta bili posebej zasnovani za oceno rezultatov biopsij endometrija, ki so bile opravljene v Združenih državah.
English: In spite of these limitations, this publication at least does not support a reduced contraceptive efficacy associated with the 84/7 regimen.
Slovenian: Kljub tem pomanjkljivostim pa ta publikacija vsaj ne kaže, da bi bil režim 84/7 povezan z manjšo kontracepcijsko učinkovitostjo.
English: From data outside the EU, since the first authorisation in 2006 until December 2013, while the estimated exposure is 385,901 women-years, only 10 pregnancies were reported resulting in a pregnancy reporting rate of 0.0026 %.
Slovenian: Glede na podatke zunaj EU je bilo od izdaje prvega dovoljenja leta 2006 do decembra 2013, pri čemer je ocenjena izpostavljenost 385 901 žensk-let, zabeleženih samo 10 primerov zanositve, kar pomeni, da je bila stopnja poročanja o zanositvi 0,0026 %.
English: The PI calculated with the Poisson method was therefore considered acceptable taking into account that the extended regimen in Seasonique is only a minor modification of an existing product.
Slovenian: Zato so menili, da je Pearlov indeks, izračunan s Poissonovo metodo, sprejemljiv, če se upošteva, da je podaljšan režim pri zdravilu Seasonique samo majhna sprememba obstoječega zdravila.
English: Moreover the applicant conducted a non-comparative pharmacodynamic (PD) study DR-105-101 during one extended cycle of 91 days (84 days of LNG/EE, followed by 7 days of EE only).
Slovenian: Poleg tega je predlagatelj izvedel neprimerjalno farmakodinamično (FD) študijo DR-105-101 z enim podaljšanim ciklom 91 dni (84 dni LNG/EE, potem pa 7 dni samo EE).
English: The CHMP was of the opinion that the benefit-risk balance of Seasonique and associated names is considered to be favourable
Slovenian: Odbor CHMP je zato menil, da se razmerje med tveganji in koristmi zdravila Seasonique in povezanih imen lahko šteje za ugodno.
English: Levonorgestrel (LGN) is a progestogen known to inhibit ovulation, whilst the low dose ethinylestradiol (EE), an estrogen, ensures control over ovarian follicular suppression and provides stability to the endometrium in order to minimise breakthrough bleeding.
Slovenian: Levonorgestrel (LNG) je progestogen, ki dokazano zavira ovulacijo, nizkoodmerni etinilestradiol (EE), ki spada med estrogene, pa omogoča nadzor nad zaviranjem ovarijskih foliklov in stabilnost endometrija, kar zmanjša vmesne krvavitve.
English: During the decentralised procedure, the Objecting Member State (OMS) was of the view that the contraceptive efficacy of Seasonique had not been sufficiently demonstrated.
Slovenian: Med decentraliziranim postopkom je država članica, ki je izrazila pomisleke, menila, da kontracepcijska učinkovitost zdravila Seasonique ni bila zadostno dokazana.
English: Having considered all the data submitted by the applicant, and the view of the BSWP, the CHMP considered that the contraceptive effectiveness of Seasonique was adequately demonstrated.
Slovenian: Potem ko je proučil vse podatke, ki jih je predložil predlagatelj, in mnenje delovne skupine za biostatistiko, je odbor CHMP menil, da je bila kontracepcijska učinkovitost zdravila Seasonique zadostno dokazana.
English: Moreover, standard 21/7-day COCs containing LGN 150 µg/ EE 30 µg are widely used and, according to the respective product information in some Member States, the cycle can be extended to 2-months, without HFI.
Slovenian: Poleg tega se standardni 21/7─dnevni režim s KPK, ki vključuje 150 µg LNG in 30 µg EE, obširno uporablja, pri čemer se glede na zadevne informacije o zdravilu v določenih državah članicah cikel lahko podaljša na 2 meseca brez presledka brez hormonov.
English: PD data showed that the ovarian inhibiting efficacy of Seasonique is within the range of that observed for other approved combined hormonal contraceptives.
Slovenian: FD-podatki so pokazali, da je učinkovitost zdravila Seasonique pri zaviranju jajčnikov znotraj razpona, ki so ga opazili pri drugih odobrenih kombiniranih hormonskih kontracepcijskih sredstvih.
English: Levels of folliclestimulating hormone (FSH), luteinizing hormone (LH), estradiol, and inhibin B were suppressed more effectively when the duration of the HFI was shortened from 7 days to 3 or 4 days per 28-day treatment cycle (Willis, 2006).
Slovenian: Zaviranje ravni folikle stimulirajočega hormona (FSH), luteinizirajočega hormona (LH), estradiola in inhibina B je bilo učinkovitejše, če se je presledek brez hormonov skrajšal s 7 na 3 ali 4 dni na 28─dnevni cikel zdravljenja (Willis 2006).
English: In addition, a 1-year retrospective study in women 15 to 40 years of age, showed that reported pregnancy rates were lower with extended regimen OC (84/7) than with ‘standard' regimens (21/7 and 24/4).
Slovenian: Poleg tega je enoletna retrospektivna študija pri ženskah, starih od 15 do 40 let, pokazala, da so bile stopnje prijavljenih zanositev nižje pri peroralnem kontraceptivu s podaljšanim režimom (84/7) kot pri tistih s „standardnim“ režimom (21/7 in 24/4).
English: Based on the results from these published clinical studies Seasonique is expected to have a greater control over ovulation, leading in turn to a higher contraceptive efficacy compared to standard 21/7day LNG/EE COCs and therefore a comparative pharmacodynamic study against standard 21/7-day LNG/EE COCs is not considered mandatory.
Slovenian: Na podlagi rezultatov iz teh objavljenih kliničnih študij pričakujejo, da bo imelo zdravilo Seasonique večji nadzor nad ovulacijo in posledično večjo kontracepcijsko učinkovitost v primerjavi s standardnimi 21/7─dnevnimi režimi KPK z LNG/EE, zato primerjalna farmakodinamična študija s standardnim 21/7─dnevnim režimom KPK z LNG/EE ni obvezna.