FrancophonIA/ELRC3.0 huggingface dataset:
English: Titanium dioxide (E171) Polysorbate 80 (E433) Iron oxide yellow (E172) Potassium aluminium silicate (E555)
Slovenian: (E171), polisorbat 80 (E433), rumeni železov oksid (E172), kalijev aluminijev silikat (E555).
English: The effects of the P-gp substrates are unlikely to have any clinical consequences.
Slovenian: Ni verjetno, da bi imeli učinki na substrate P-gp kakršne koli klinične posledice.
English: Midsona Norge AS Tlf: + 47 24 11 01 00
Slovenian: Tlf: + 47 24 11 01 00
English: You can take the tablet at any time in the menstrual cycle.
Slovenian: Tableto lahko vzamete v katerem koli času menstrualnega ciklusa.
English: IUD (intrauterine device)
Slovenian: Maternični vložek (IUV)
English: The tablet can be taken at any time during the menstrual cycle.
Slovenian: Tableto se lahko zaužije kadar koli med menstrualnim ciklusom.
English: Orivas OÜ Tel: +372 639 8845
Slovenian: Tel: +372 639 8845
English: Midsona Finland Oy Puh/Tel: + 358-(0) 20 743 4755
Slovenian: Suomi/Finland Midsona Finland Oy Puh/Tel: + 358-(0) 20 743 4755
English: Česká republika
Slovenian: ČEŠKA
English: Experience with ulipristal acetate overdose is limited.
Slovenian: Izkušnje s prevelikim odmerjanjem ulipristalacetata so omejene.
English: In the absence of specific studies, no alternate dose recommendations for ulipristal acetate can be made.
Slovenian: Zaradi pomanjkanja specifičnih študij za ulipristalacetat ni mogoče podati priporočil za drugačno odmerjanje.
English: ellaOne 30 mg tablet
Slovenian: ellaOne 30 mg tableta
English: Do not use this medicine after the expiry date which is on the carton and on the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: - diarrhoea, heartburn, wind, dry mouth - unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal irritation or discharge, lesser or greater sex drive - hot flushes - appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine visual disturbances - influenza - acne, skin lesions, itching - fever, chills, malaise
Slovenian: - driska, zgaga, vetrovi, suha usta - neobičajna ali neredna krvavitev iz nožnice, močne/podaljšane menstruacije, predmenstrualni sindrom, draženje ali izcedek iz nožnice, šibkejši ali močnejši spolni nagon - oblivi vročine - spremembe v apetitu, emocionalne motnje, tesnoba, vznemirjenost, težave s spanjem, zaspanost,
English: fosphenytoine, carbamazepine, oxcarbazepine and barbiturates) - medicines used to treat tuberculosis (for example, rifampicin, rifabutin) - a treatment for HIV (ritonavir, efavirenz, nevirapine) - a medicine used to treat fungal infections (griseofulvin) - herbal remedies containing St John's wort (Hypericum perforatum).
Slovenian: okskarbazepin in barbiturati), - zdravila za zdravljenje tuberkuloze (npr. rifampicin, rifabutin), - zdravila za zdravljenje HIV (ritonavir, efavirenz, nevirapin), - zdravilo, s katerim zdravimo okužbe z glivicami (grizeofulvin), - zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum).
English: Adolescents: ulipristal acetate for emergency contraception is suitable for any woman of child bearing age, including adolescents.
Slovenian: Mladostnice: ulipristalacetat za nujno kontracepcijo je primeren za vsako žensko v rodni dobi, vključno z mladostnicami.
English: How ellaOne works ellaOne contains the substance ulipristal acetate which acts by modifying the activity of the natural hormone progesterone which is necessary for ovulation to occur.
Slovenian: Ta deluje tako, da spremeni delovanje naravnega hormona progesterona, ki je potreben za nastop ovulacije.
English: See leaflet for further information
Slovenian: Vsebina pakiranja in dodatne informacije
English: Contraception after ellaOne intake
Slovenian: Kontracepcija po zaužitju zdravila ellaOne
English: Administration of ulipristal acetate together with a high-fat breakfast resulted in approximately 45% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean AUC0-∞ compared with administration in the fasted state.
Slovenian: Če se ulipristalacetat zaužije med zajtrkom z visoko vsebnostjo maščob, se povprečni Cmax zniža približno za 45 %, čas do tmax se podaljša (s srednje vrednosti 0,75 ure na 3 ure), povprečni AUC0-∞ pa se v primerjavi z jemanjem na tešče poviša za 25 %.
English: ROUMANIA
Slovenian: ROMUNIJA
English: Ulipristal acetate does not interrupt an existing pregnancy.
Slovenian: Ulipristalacetat ne prekine obstoječe nosečnosti.
English: Concomitant use of ellaOne with CYP3A4 inducers (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.
Slovenian: Sočasna uporaba zdravila ellaOne in induktorjev CYP3A4 (npr. barbiturati (vključno s primidonom in fenobarbitalom), fenitoin, fosfenitoin, karbamazepin, okskarbazepin, zdravila rastlinskega izvora, ki vsebujejo Hypericum perforatum (šentjanževko), rifampicin, rifabutin, grizeofulvin, efavirenz in nevirapin) tako zmanjša koncentracije ulipristalacetata v plazmi ter lahko posledično zmanjša učinkovitost zdravila ellaOne.
English: If you miss your period and experience such symptoms after taking ellaOne, you should do a pregnancy test (see section 2 “Pregnancy, breastfeeding and fertility”).
Slovenian: Če niste dobili menstruacije in so se pri vas pojavili takšni simptomi po uporabi zdravila ellaOne, morate opraviti test nosečnosti (glejte poglavje 2 »Nosečnost, dojenje in plodnost«).
English: Concomitant use of ellaOne with CYP3A4 inducers is not recommended due to interaction (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicinal products containing Hypericum perforatum (St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine and long term use of ritonavir).
Slovenian: Sočasne uporabe zdravila ellaOne z induktorji CYP3A4 se zaradi medsebojnega delovanja ne priporoča (npr. barbiturati (vključno s primidonom in fenobarbitalom), fenitoin, fosfenitoin, karbamazepin, okskarbazepin, zdravila rastlinskega izvora, ki vsebujejo Hypericum perforatum (šentjanževko), rifampicin, rifabutin, grizeofulvin, efavirenz, nevirapin in dolgotrajna uporaba ritonavirja).
English: Pregnancy, breast-feeding and fertility
Slovenian: Nosečnost, dojenje in plodnost Nosečnost
English: BELGIUM
Slovenian: BELGIJA
English: Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Slovenian: Nujna kontracepcija v 120 urah (5 dneh) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
English: Rare side effects (may affect up to 1 in 1,000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Ulipristal acetate is extensively metabolised to mono-demethylated, di-demethylated and hydroxylated metabolites.
Slovenian: Ulipristalacetat se večinoma presnavlja v monodemetilirane, didemetilirane in hidroksilirane presnovke.
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: During this time, it is recommended to use a breast pump in order to maintain milk production, but throw away your breast milk.
Slovenian: V tem času vam priporočamo, da si mleko iztiskate s prsno črpalko in ga zavržete, da tako ohranite zmožnost dojenja.
English: If you have sex again after taking ellaOne
Slovenian: Če imate po zaužitju zdravila ellaOne ponovno spolne odnose
English: HRA Pharma Benelux Tel: +32 2 709 2295
Slovenian: Nederland HRA Pharma Benelux Tel: +32 2 709 2295
English: In vivo results show that administration of ulipristal acetate with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and 5.9-fold, respectively.
Slovenian: Rezultati in vivo so pokazali, da je uporaba ulipristalacetata z močnim in zmernim zaviralcem CYP3A4 povečala vrednosti ulipristalacetata Cmax za 2-krat in AUC za 5,9-krat.
English: Tablet White to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
Slovenian: Bela oz. kremasta marmorirana, okrogla, zaobljena tableta premera 9 mm z vtisnjeno oznako „ella“ na obeh straneh.
English: Ulipristal acetate
Slovenian: Ulipristalacetat
English: If you miss your period and experience such symptoms after taking ellaOne, you should do a pregnancy test (See section “Pregnancy, breastfeeding and fertility”).
Slovenian: Če niste dobili menstruacije in so se pri vas pojavili takšni simptomi po uporabi zdravila ellaOne, morate opraviti test nosečnosti (glejte poglavje »Nosečnost, dojenje in plodnost«).
English: For example: - if you had sex without protection; - if your or your partner's condom tore, slipped or came off, or if you forgot to use one; - if you did not take your contraceptive pill as recommended.
Slovenian: Zdravilo ellaOne je kontracepcijsko sredstvo, namenjeno preprečitvi nosečnosti po nezaščitenem spolnem odnosu ali ko je kontracepcijska metoda neučinkovita, na primer: - če ste imeli nezaščiten spolni odnos; - če se je vaš kondom ali kondom vašega partnerja strgal, zdrsnil ali se snel ali če ste ga pozabili uporabiti; - če niste jemali kontracepcijskih tablet po navodilih.
English: You must take this medicine within 120 hours (5 days) of unprotected sex or contraceptive failure.
Slovenian: Zdravilo morate vzeti v 120 urah (5 dneh) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
English: Weekly or monthly methods
Slovenian: Primeri rednih kontracepcijskih metod: Dnevne metode Kontracepcijska tableta Tedenske ali mesečne metode Kontracepcijski obliž
English: Pregnancy may occasionally occur after ulipristal acetate intake.
Slovenian: Po uporabi ulipristalacetata lahko občasno nastopi nosečnost.
English: PVC-PVDC (with UV filter) / Aluminium blister of 1 tablet.
Slovenian: Pretisni omot iz PVC-PVDC-aluminija (z UV-filtrom) z eno tableto.
English: If you become pregnant despite taking this medicine, it is important that you see your doctor.
Slovenian: Če kljub uporabi tega zdravila zanosite, nujno obiščite svojega zdravnika.
English: Ulipristal acetate inhibits or postpones ovulation (see section 5.1).
Slovenian: Ulipristalacetat zavre ali odloži ovulacijo (glejte poglavje 5.1).
English: PVC-PE-PVDC-Aluminium blister of 1 tablet.
Slovenian: Pretisni omot iz PVC-PE-PVDC-aluminija z eno tableto.
English: CROATIA
Slovenian: HRVAŠKA
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives.
Slovenian: Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, urgentni kontraceptivi, oznaka ATC: G03AD02.
English: Tablet core: lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate Film coating: poly(vinyl alcohol) (E1203), macrogol (E1521), talc (E553b), titanium dioxide (E171), polysorbate 80 (E433), iron oxide yellow (E172), potassium aluminium silicate (E555)
Slovenian: Filmska obloga: polivinilalkohol (E1203) makrogol (E1521) smukec (E533b) titanov dioksid (E171) polisorbat 80 (E433) železov oksid, rumeni (E172) kalijev aluminijev silikat (E555)
English: Talk to your pharmacist, doctor or other healthcare professional before taking this medicine - if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant (see section “Pregnancy, breast-feeding and fertility”); - if you suffer from severe asthma; - if you suffer from severe liver disease.
Slovenian: - če vam menstruacija zamuja ali imate simptome nosečnosti (težke prsi, jutranja slabost), saj ste morda že noseči (glejte poglavje »Nosečnost, dojenje in plodnost«); - če imate hudo astmo; - če imate hudo bolezen jeter.
English: If you are currently taking hormonal contraception, continue to use it as usual after taking this medicine, but be sure to use condoms every time you have sex until your next period.
Slovenian: Če trenutno jemljete hormonsko kontracepcijo, jo po uporabi tega zdravila še naprej uporabljajte kot običajno, vendar morate do naslednje menstruacije uporabiti kondom vsakič, ko imate spolne odnose.
English: Adverse reactions (frequency) System organ class Common
Slovenian: Neželeni učinki (pogostnost)
English: Placebo n=50
Slovenian: Preprečitev ovulacije1,§ Placebo n = 50
English: Film-coated tablet
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta
English: Poly(vinyl alcohol) (E1203) Macrogol (E1521) Talc (E553b)
Slovenian: - Filmska obloga: polivinilalkohol (E1203), makrogol (E1521), smukec (E553b), titanov dioksid
English: The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.
Slovenian: Zdravljenje poteka peroralno, in sicer se zaužije ena tableta čim prej, vendar najkasneje 120 ur (5 dni) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
English: You can also report this information on your own at www.hra-pregnancy-registry.com.Your information will remain anonymous - nobody will know it is information about you.
Slovenian: O tem lahko poročate tudi sami na spletnem naslovu www.hra-pregnancy-registry.com.
English: - Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after unprotected sex or contraceptive failure.
Slovenian: - Zaužijte eno tableto čim prej, najpozneje pa 5 dni (120 ur) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
English: If you are currently taking hormonal contraception, continue to use it as usual after taking the tablet, but be sure to use condoms every time you have sex until your next period.
Slovenian: Če trenutno jemljete hormonsko kontracepcijo, jo po uporabi tablete še naprej uporabljajte kot običajno, vendar morate do naslednje menstruacije uporabiti kondom vsakič, ko imate spolne odnose.
English: In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations.
Slovenian: Podatki in vitro kažejo, da je lahko ulipristalacetat v klinično pomembnih koncentracijah zaviralec Pglikoproteina.
English: No differences in safety or efficacy have been shown compared to adult women aged 18 and older (see section 5.1).
Slovenian: V varnosti in učinkovitosti niso opazili nobenih razlik v primerjavi z odraslimi ženskami, starimi
English: COUNTRY
Slovenian: DRŽAVA
English: A.
Slovenian: NS*
English: Speak to your doctor or pharmacist before using ellaOne.
Slovenian: Pred uporabo zdravila ellaOne se posvetujte z zdravnikom ali farmacevtom.
English: What ellaOne looks like and contents of the pack ellaOne is a golden film-coated tablet of shield shape (around 10.8 mm diameter) with “ella” engraved on both sides.
Slovenian: Izgled zdravila ellaOne in vsebina pakiranja Zdravilo ellaOne je filmsko obložena tableta zlate barve v obliki ščita (približnega premera 10,8 mm)
English: What ellaOne looks like and contents of the pack ellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
Slovenian: Zdravilo ellaOne je bela do kremasta marmorirana, okrogla, zaobljena tableta premera 9 mm z oznako „ella“ na obeh straneh.
English: If you have unprotected sex after taking this medicine, it will not stop you from becoming pregnant.
Slovenian: Če imate nezaščiten spolni odnos po zaužitju tega zdravila, zdravilo ne bo preprečilo zanositve.
English: Deutschland
Slovenian: NEMČIJA
English: PVC-PVDC-Aluminium blister of 1 tablet.
Slovenian: Pretisni omot iz PVC-PVDC-aluminija z eno tableto.
English: How to take the ellaOne tablet
Slovenian: Kako jemati zdravilo ellaOne
English: HRA Pharma Benelux Tél/Tel: +32 2 709 2295
Slovenian: Luxembourg/Luxemburg HRA Pharma Benelux Tél/Tel: +32 2 709 2295
English: You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.
Slovenian: Če ste zaskrbljeni glede kakršnih koli težav, povezanih z jemanjem nujne kontracepcije, je priporočljivo, da se posvetujete z zdravstvenim delavcem.
English: After you take the tablet and until your next period comes, you should use condoms every time you have sex.
Slovenian: Po tem, ko ste vzeli tableto in do naslednje menstruacije morate uporabiti kondom vsakič, ko imate spolne odnose.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij Cenexi
English: sucursal em Portugal Tel: +351 707 501 996
Slovenian: Tel: +351 707 501 996
English: Τηλ: + 30-(0) 210 66 83 000
Slovenian: ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ Τηλ: + 30-(0)210 66 83 000
English: Τηλ: + 30-(0)210 66 83 000
Slovenian: ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ Τηλ: + 30-(0) 210 66 83 000
English: - nausea, abdominal (stomach) pain or discomfort, vomiting - painful periods, pelvic pain, breast tenderness - headache, dizziness, mood swings
Slovenian: - siljenje na bruhanje, bolečine ali neprijeten občutek v trebuhu, bruhanje - boleče menstruacije, bolečine v medenici, občutljive dojke - glavobol, omotica, nihanje razpoloženja - bolečine v mišicah, bolečine v hrbtu, utrujenost
English: after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.
Slovenian: Zato je treba ženski svetovati, naj po uporabi nujne kontracepcije uporablja zanesljivo pregradno metodo do naslednje menstruacije.
English: - genital pain or itching, pain during sex, rupture of an ovarian cyst, unusually light period - loss of concentration, vertigo, shaking, disorientation, fainting - unusual sensation in eye, red eye, sensitivity to light - dry throat, disturbance in taste - hives (itchy rash), feeling thirsty
Slovenian: nenavadno šibka menstruacija - poslabšanje koncentracije, vrtoglavica, tresenje, dezorientacija, omedlevica - nenormalen občutek v očesu, rdeče oči, občutljivost oči na svetlobo - suho grlo, motnje v okušanju - koprivnica (srbeč izpuščaj), občutek žeje
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora suho grlo
English: After single dose administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not likely.
Slovenian: Indukcija CYP1A2 in CYP3A4 z ulipristalacetatom ali njegovim aktivnim presnovkom po enkratnem odmerjanju ni verjetna, zato tudi ni verjetno, da bo ulipristalacetat spremenil očistek zdravil, ki jih presnavljajo ti encimi.
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: LATVIA
Slovenian: LATVIJA
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM LABORATOIRE HRA PHARMA
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM HRA Pharma
English: Each film-coated tablet contains 30 milligrams of ulipristal acetate.
Slovenian: Ena filmsko obložena tableta vsebuje 30 mg ulipristalacetata.
English: ellaOne 30 mg film-coated tablet
Slovenian: ellaOne 30 mg filmsko obložena tableta
English: SWEDEN
Slovenian: ŠVEDSKA
English: Infections and infestations
Slovenian: Infekcijske in parazitske bolezni gripa
English: Ulipristal acetate has minor or moderate influence on the ability to drive or use machines: mild to moderate dizziness is common after ellaOne intake, somnolence and blurred vision are uncommon; disturbance in attention has been rarely reported.
Slovenian: Po zaužitju zdravila ellaOne se pogosto pojavi blaga do zmerna omotica, občasno pa zaspanost in zamegljen vid. O motnjah pozornosti pa so poročali redko.
English: - If you get any side effects, talk to your pharmacist, doctor, or other healthcare professional.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s farmacevtom, zdravnikom ali drugim zdravstvenim delavcem.
English: There have been no reports of harmful effects from taking a higher dose than recommended of this medicine However do ask your pharmacist, doctor or other healthcare professional for advice.
Slovenian: Ni poročil o tem, da bi zaužitje večjega odmerka tega zdravila od priporočenega imelo škodljive učinke.
English: <{DD/MM/YYYY}>
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA <{DD/MM/LLLL}>
English: 2D barcode carrying the unique identifier included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
English: Κύπρος ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ
Slovenian: Κύπρος
English: If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant.
Slovenian: Če imate nezaščiten spolni odnos po zaužitju tablete, zdravilo ne bo preprečilo zanositve.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja akne kožne lezije pruritus koprivnica
English: LITUANIA
Slovenian: LITVA
English: Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila farmacevta, zdravnika ali drugega zdravstvenega delavca.
English: NETHERLANDS www.hra-pharma.com/PIL/NL NORWAY
Slovenian: NIZOZEMSKA www.hra-pharma.com/PIL/NL NORVEŠKA
English: Genital pruritus Dyspareunia Ruptured ovarian cyst Vulvovaginal pain Hypomenorrhea*
Slovenian: Motnje reprodukcije in dojk dismenoreja bolečine v medenici občutljive dojke menoragija vaginalni izcedek menstruacijske motnje metroragija vaginitis vročinski oblivi predmenstruacijski sindrom genitalni pruritus bolečine med spolnim odnosom počena cista na jajčniku vulvovaginalne bolečine hipomenoreja*
English: Results from two independent randomised controlled trials (see Table) showed the efficacy of ulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure.
Slovenian: Rezultati dveh neodvisnih randomiziranih kontroliranih kliničnih preskušanj (poglej tabelo spodaj) so pokazali, da učinkovitost ulipristalacetata ni nižja od učinkovitosti levonorgestrela.
English: Somnolence Migraine
Slovenian: migrena, motnje vida
English: A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception.
Slovenian: Po zdravljenju z ulipristalacetatom za namene nujne kontracepcije je verjetno, da bo plodnost hitro znova vzpostavljena.
English: AUSTRIA
Slovenian: AVSTRIJA
English: Each tablet contains 30 mg ulipristal acetate.
Slovenian: Ena tableta vsebuje 30 mg ulipristalacetata.
English: After you take emergency contraception and until your next period comes, you should use a condom every time you have sex.
Slovenian: Od uporabe nujne kontracepcije do naslednje menstruacije morate uporabiti kondom vsakič, ko imate spolni odnos.
English: ellaOne 30 mg tablet Ulipristal acetate
Slovenian: ellaOne 30 mg tableta ulipristalacetat
English: If you get any side effects, talk to your pharmacist, doctor or other healthcare professional.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte s farmacevtom, zdravnikom ali drugim zdravstvenim delavcem.
English: However, it does not interrupt an existing pregnancy (see section ellaOne does not prevent pregnancy in every case
Slovenian: Zdravilo ellaOne ne prepreči nosečnosti v vsakem primeru
English: - CYP3A4 inducers
Slovenian: Ulipristalacetat se in vitro presnavlja s CYP3A4: − Induktorji CYP3A4
English: How to take the ellaOne film-coated tablet
Slovenian: Kako vzeti filmsko obloženo tableto zdravila ella One