natgillin/translations-raw huggingface dataset:
Pack sizes of 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes.
Na voljo je pakiranje s 4 napolnjenimi injekcijskimi brizgami in skupno pakiranje, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih brizg.
In the RoActemra subcutaneous weekly group, one patient (1.1%, 1/95) developed positive neutralizing anti-RoActemra antibodies, though not of the IgE isotype.
1/95) pojavila pozitivna nevtralizirajoča protitelesa proti zdravilu RoActemra, ki pa niso bila izotipa IgE.
Of the 46 patients (1.6%) who developed anti-RoActemra antibodies, 6 had an associated medically significant hypersensitivity reaction, of which 5 led to permanent discontinuation of treatment.
jih je 6 imelo spremljajočo klinično pomembno preobčutljivostno reakcijo, ki je v 5 primerih vodila v ukinitev zdravljenja.
During routine laboratory monitoring in the RoActemra 6 month controlled clinical trial SC-I, 19% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dl), with 9% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L(160 mg/dL) on the subcutaneous weekly dose.
Vrednosti lipidov V okviru rutinskega laboratorijskega spremljanja v šestmesečnem kontroliranem kliničnem preskušanju zdravila RoActemra SC-I se je pri 19 % bolnikov, ki so prejemali subkutani tedenski odmerek, pojavilo dolgotrajno zvišanje celotnega holesterola na > 6,2 mmol/l (240 mg/dl), pri 9 %
Exploratory efficacy results showed that RoActemra SC improved all exploratory efficacy parameters including Juvenile Arthritis Disease Activity Score (JADAS)-71, for TCZ naïve patients and maintained all exploratory efficacy parameters for patients who switched from RoActemra IV to RoActemra SC treatment over the entire course of the study for patients in both body weight groups
Eksploratorni rezultati učinkovitosti so pokazali, da je zdravilo RoActemra v subkutani obliki izboljšalo vse eksploratorne parametre učinkovitosti, vključno z indeksom za juvenilni artritis
The pharmacokinetics of tocilizumab in pJIA patients was characterized by a population pharmacokinetic analysis which included 237 patients who were treated with 8 mg/kg IV every 4
Farmakokinetiko tocilizumaba so proučili s populacijsko farmakokinetično analizo podatkov 3552
During the double-blind controlled period and with long-term exposure, the pattern and incidence of decreases in platelet counts remained consistent with what was seen in the 6-month controlled clinical trials.
V obdobju dvojno slepe kontrole ter pri dolgoročni izpostavljenosti sta vzorec in incidenca zmanjšanja števila trombocitov ostala skladna s tem, kar so opazili v šestmesečnih kontroliranih kliničnih preskušanjih.
Similarly the proportion of patients achieving a DAS 28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving RoActemra 8 mg/kg plus DMARD than in patients receiving RoActemra 4 mg/kg plus DMARD (p< 0.0001).
(DAS28 < 2,6) značilno večji delež bolnikov, ki so dobivali 8 mg/kg zdravila RoActemra skupaj z imunomodulirajočimi antirevmatičnimi zdravili, kot bolnikov, ki so dobivali 4 mg/kg zdravila RoActemra skupaj z imunomodulirajočimi antirevmatičnimi zdravili (31 % v prim.
Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 were observed in tocilizumab-treated patients compared to control patients (1.3-2.1).
Pri bolnikih, zdravljenih s tocilizumabom, so ugotovili značilno znižanje (povprečno izboljšanje) DAS28 za 3,1 do 3,4 od izhodišča v primerjavi s kontrolnimi bolniki
Tell your doctor immediately if you feel unwell.
Če se ne počutite dobro, morate to nemudoma povedati zdravniku.
Reduction of tocilizumab dose due to laboratory abnormalities has not been studied in sJIA patients.
Zmanjšanja odmerka tocilizumaba zaradi nenormalnih laboratorijskih vrednosti pri bolnikih s sJIA
Elevations of ALT/AST > 5 x ULN were observed in 0.7% of tocilizumab monotherapy patients and 1.4% of tocilizumab plus DMARD patients, the majority of whom were discontinued permanently from tocilizumab treatment.
bolnikov, ki so dobivali tocilizumab v monoterapiji, in pri 1,4 % bolnikov, ki so tocilizumab dobivali v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili; pri večini teh so zdravljenje s tocilizumabom ukinili.
Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.
Napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo in vlago.
• Patient Information Pack
• izobraževalno gradivo za bolnike.
Skin and subcutaneous tissue disorders
prsnega koša in mediastinalnega prostora kašelj, dispneja
Because RoActemra is given in one pre-filled syringe, it is unlikely that you will receive too much.
Če ste uporabili večji odmerek zdravila RoActemra, kot bi smeli Ker je zdravilo RoActemra pripravljeno v eni napolnjeni injekcijski brizgi, ni verjetno, da bi uporabili prevelik odmerek.
Leukopenia, Neutropenia, Hypofibrinogenae mia
Bolezni živčevja glavobol, omotica
Doses of 4 or 8 mg/kg RoActemra or placebo were given every four weeks, in combination with stable MTX (10 mg to 25 mg weekly).
8 mg/kg zdravila RoActemra ali placebo so dobivali na štiri tedne v kombinaciji s stabilnim odmerkom metotreksata (od 10 do 25 mg na teden).
• Do not try to take apart the pre-filled pen at any time.
• Ne poskušajte odpreti ali razstaviti napolnjene injekcijske brizge.
cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200 mg/dL at any time during study treatment, respectively.
≥ 130 mg/dl in 35,4 % bolnikov zvišano vrednost celokupnega holesterola na ≥ 200 mg/dl.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 162 mg tocilizumab
1 napolnjena injekcijska brizga vsebuje 162 mg tocilizumaba.
Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to slightly yellowish, or any part of the pre-filled syringe appears to be damaged.
Ne uporabite zdravila, če je raztopina motna ali vsebuje lebdeče delce, če je barva zdravila drugačna od brezbarvne do rahlo rumenkaste in če ste opazili, da je kateri koli del napolnjene injekcijske brizge poškodovan.
• If a dose is missed within 7 days, inject a dose as soon as you remember and give the next dose at the regular scheduled time.
• Če je od izpuščenega odmerka minilo manj kot 7 dni, odmerek injicirajte takoj, ko se spomnite,
For MCS, the mean change from baseline to week 52 for both RoActemra weekly and every other weekly dose groups [7.28, 6.12, respectively] were higher than the placebo plus 52 weeks prednisone taper group [2.84] (although the differences were not statistically significant [weekly p=0.0252 for weekly, p=0.1468 for every other weekly]) and similar to the placebo plus 26 weeks prednisone taper group [6.67].
MCS od izhodišča do 52. tedna je bila tako z zdravilom RoActemra vsak teden [7,28] kot vsaka dva tedna [6,12] večja kakor s placebom v kombinaciji z 52-tedenskim zmanjševanjem prednizona [2,84]
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or CRS.
Zdravljenje mora vpeljati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa, sJIA, poliartikularnega juvenilnega idiopatskega poliartritisa (pJIA) ali sindromom sproščanja citokinov.
During the double-blind controlled period and with long-term exposure, the pattern and incidence of elevations in lipid parameters remained consistent with what was seen in the 6-month controlled trials.
V obdobju dvojno slepe kontrole ter pri dolgoročni izpostavljenosti sta vzorec in incidenca zvišanja vrednosti lipidov ostala skladna s tem, kar so opazili v šestmesečnih kontroliranih kliničnih preskušanjih.
Keep the pre-filled syringe in the outer carton in order to protect from light and moisture.
Napolnjene injekcijske brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo in vlago.
Mild renal impairment
Bolezni sečil nefrolitiaza
Predicted mean ± SD PK parameters at steady-state after IV dosing in sJIA RoActemra PK Parameter
Predvideno povprečje ± std. odklon farmakokinetičnih parametrov v stanju dinamičnega ravnovesja po intravenskem odmerjanju pri bolnikih s Sjia
Doses of 8 mg/kg of RoActemra were given every four weeks as monotherapy.
RoActemra so uporabljali kot monoterapijo v odmerku 8 mg/kg na štiri tedne.
Eligible patients received RoActemra dosed according to body weight (BW), with patients weighing
Bolniki, primerni za vključitev v študijo, so prejemali zdravilo RoActemra glede na telesno maso;
• Do not fan or blow on the clean area.
• Očiščene površine ne sušite s fenom in nanjo ne pihajte.
Endocrine disorders
Bolezni endokrinega sistema hipotiroidizem
The risk of malignancy is increased in patients with RA.
Bolniki z revmatoidnim artritisom imajo večje tveganje za malignome.
• Caution should be exercised when considering initiation of tocilizumab treatment in patients with elevated transaminases ALT or AST above 1.5x ULN.
• Pri odločitvi o uvedbi zdravljenja pri bolnikih, ki imajo vrednost ALT ali AST več kot 1,5-krat višjo od zgornje meje normalne vrednosti (ZMN), je potrebna previdnost.
The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg tocilizumab every 4 weeks for 24 weeks or with 162 mg tocilizumab given subcutaneously either once a week or every other week for 24 weeks.
bolnikov z revmatoidnim artritisom, ki so 24 tednov na 4 tedne dobivali enourno infuzijo 4 ali 8 mg/kg tocilizumaba, ali 24 tednov 162 mg tocilizumaba subkutano bodisi enkrat tedensko ali vsak drugi teden.
In general, side effects in sJIA patients were of a similar type to those in adults with RA.
Otroci s sJIA V splošnem so neželeni učinki, opaženi pri bolnikih s sJIA, podobni tistim pri bolnikih z revmatoidnim artritisom.
What RoActemra looks like and contents of the pack RoActemra is a concentrate for solution for infusion.
Zdravilo RoActemra je koncentrat za raztopino za infundiranje.
Interrupt RoActemra dosing.
RoActemra za bolnikov odmerek.
MTX naïve, Early RA Study VII (WA19926), a 2 year study with the planned primary analysis at week 52 evaluated 1162
Študija VII (WA19926) je bila dveletna študija z načrtovano primarno analizo v 52. tednu; ocenila je 1162 odraslih bolnikov z zmernim do hudim, aktivnim, zgodnjim revmatoidnim artritisom (povprečno trajanje bolezni ≤ 6 mesecev), ki se še niso zdravili z metotreksatom.
In paediatric patients with pJIA, the central volume of distribution was 1.97 L, the peripheral volume of distribution was 2.03 L, resulting in a volume of distribution at steady state of 4.0 L.
Pri pediatričnih bolnikih je bil centralni volumen porazdelitve 1,97 l in periferni volumen porazdelitve
NAME OF THE MEDICINAL PRODUCT RoActemra 20 mg/mL concentrate for solution for infusion.
RoActemra 20 mg/ml koncentrat za raztopino za infundiranje
Predicted mean ± SD PK parameters at steady-state after subcutaneous dosing in GCA Subcutaneous
Predvideno povprečje ± std. odklon farmakokinetičnih parametrov v stanju dinamičnega ravnovesja po subkutanem odmerjanju pri bolnikih s sJIA
At week 24, a significant reduction in DAS28 from baseline (mean improvement) of 3.5 was observed on both treatment arms, and a comparable proportion of patients had achieved DAS28 clinical remission (DAS28 < 2.6) on the subcutaneous (38.4%) and IV (36.9%) arms.
Tudi delež bolnikov, ki so dosegli klinično remisijo glede na DAS28 (DAS28 < 2,6) v subkutani (38,4 %) in intravenski skupini (36,9 %), je bil primerljiv.
(See Fig.
in pJIA.
Platelet count decreased sJIA
zmanjšanje števila trombocitov sJIA
You are not to be given RoActemra
Kako boste prejeli zdravilo RoActemra
• Hold the syringe comfortably in your hand.
• Sproščeno držite napolnjeno injekcijsko brizgo.
Paediatric population sJIA Patients
Uporaba pri pediatrični populaciji
Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in sJIA patients in the tables below.
V primeru nenormalnih laboratorijskih vrednosti je pri bolnikih s sJIA priporočljivo uporabo tocilizumaba prekiniti, kot je opisano v spodnjih preglednicah.
Cmean (µg/mL)
Csrednja (µg/ml)
Upper respiratory tract infections
Preiskave zvišanje jetrnih transaminaz,
In Study IV, RoActemra was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
RoActemra dajali intravensko na 4 tedne v kombinaciji z drugimi imunomodulirajočimi antirevmatičnimi zdravili; primerjava je bila kombinacija placeba in imunomodulirajočih antirevmatičnih zdravil.
These may affect up to 1 in every 1,000 users
Ti se lahko pojavijo pri največ 1 od 1000 bolnikov.
An elevation in AST > 3 ULN occurred in 1% of patients in the RoActemra subcutaneous weekly group, compared to no patients in either of the placebo plus prednisone taper groups.
bolnikov, ki so prejemali zdravilo RoActemra subkutano vsak teden, in pri nobenem bolniku v skupinah s placebom in postopnim zmanjševanjem prednizona.
PHARMACEUTICAL FORM Solution for injection in pre-filled pen (ACTPen).
raztopina za injiciranje v napolnjenem injekcijskem peresniku (ACTPen) Bistra do rahlo rumenkasta raztopina.
Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to yellowish, or any part of the pre-filled pen appears to be damaged.
Ne uporabite zdravila, če je raztopina motna ali vsebuje lebdeče delce, če je barva zdravila drugačna od brezbarvne do rahlo rumenkaste in če ste opazili, da je kateri koli del napolnjenega injekcijskega peresnika poškodovan.
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
(9 mg/ml) raztopine natrijevega klorida za injiciranje, kot je potrebni volumen koncentrata zdravila
Rotate Injection Site
Menjava mest injiciranja
Date of first authorisation: 15 May 2009 Date of latest renewal: 21 March 2014
Datum prve odobritve:15. maj 2009 Datum zadnjega podaljšanja: 21. marec 2014
You should do a pregnancy test right away.
Takoj morate opraviti test nosečnosti.
The sooner you take emergency contraception, the better the chance of avoiding pregnancy.
Prej ko vzamete nujno kontracepcijo, boljša je možnost, da se boste izognili nosečnosti.
However, it is important that you see your doctor.
Vendar je pomembno, da obiščete svojega zdravnika.
All patient data collected will remain anonymous.
Vsi zbrani podatki o bolnicah bodo ostali anonimni.
The tablet can be taken with or without food.
Tableta se lahko zaužije s hrano ali brez nje.
The effect on newborn/infants has not been studied.
Učinka na novorojenčke/dojenčke niso preučevali.
A risk to the breastfed child cannot be excluded.
Tveganja za dojenega otroka ni mogoče izključiti.
*Symptom which could also be related to an undiagnosed pregnancy (or related complications)
* Simptom, ki bi lahko bil povezan tudi z nediagnosticirano nosečnostjo (ali povezanimi zapleti).
Emergency contraception is not effective in every case.
Nujna kontracepcija ni učinkovita v vseh primerih.
There are no antidotes and further treatment should be symptomatic.
Na voljo ni nobenega antidota, nadaljnje zdravljenje pa mora biti simptomatsko.
NS: non statistically significant †: compared to placebo
NS: ni statistično značilno †: v primerjavi s placebom
Of 100 women who take this medicine approximately 2 will become pregnant.
Od 100 žensk, ki vzamejo to zdravilo, zanosita približno dve.
There are many different types of contraception available, and you should be able to find the right method for you.
Na voljo je veliko različnih vrst kontracepcije in zagotovo vam bo uspelo najti pravo zase.
Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.
Varnost ulipristalacetata je bila ocenjena na vzorcu 4.718 žensk v času razvojnega kliničnega programa.
The adverse reactions reported in the phase III program of 2,637 women are provided in the table below.
Neželeni učinki, o katerih so poročali v III. fazi programa na vzorcu 2.637 žensk, so podani v spodnji preglednici.
Biotransformation/elimination
Biotransformacija/izločanje
If your menstrual period is late, there is a possibility that you may be pregnant.
Če vam menstruacija zamuja, obstaja možnost, da ste noseči.
At these repeated doses, the safety for a human embryo is unknown.
Pri teh ponavljajočih se odmerkih varnost za človeški zarodek ni znana.
Only condoms can protect you from sexually transmitted infections.
Samo kondomi vas lahko zaščitijo pred spolno prenosljivimi okužbami.
Therefore it is important you use condoms until your next period.
Zato je pomembno, da do naslednje menstruacije uporabljate kondome.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
Do not throw away any medicines via waste water.
Zdravila ne smete odvreči v odpadne vode.
- Ask your pharmacist if you need more information or advice.
- Posvetujte se s farmacevtom, če potrebujete dodatne informacije ali nasvet.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Adolescents:
Mladostnice:
However, in humans, no such effect has been observed even after repeat administration at the daily dose of 10 mg.
Ne glede na to pa ti učinki pri človeku niso bili opaženi niti po ponavljajočem se jemanju 10-miligramskih dnevnih odmerkov.
Single doses up to 200 mg have been used in women without safety concern.
Enkratne odmerke do 200 mg so prejemale ženske brez zdravstvenih težav.
There is more information about contraception at the end of this leaflet.
Več informacij o kontracepciji je na voljo na koncu tega navodila za uporabo.
Some medicines may prevent ellaOne from working effectively.
Nekatera zdravila lahko preprečijo, da zdravilo ellaOne deluje učinkovito.
In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of ellaOne (73 women enrolled twice and 9 enrolled three times).
V študiji III. faze je 82 žensk sodelovalo več kot enkrat in je zato prejelo več kot en odmerek zdravila ellaOne (73 žensk se je v študijo vključilo dvakrat in 9 žensk trikrat).
If ovulation has already occurred, it is no longer effective.
Če je ovulacija že nastopila, zdravilo ni več učinkovito.
This medicine will not affect your future fertility.
To zdravilo ne bo vplivalo na vašo plodnost v prihodnosti.
The patient should be informed not to drive or use machines if they are experiencing such symptoms (see section 4.8).
Uporabnico je treba obvestiti, da ne sme voziti ali upravljati strojev, če opazi takšne simptome (glejte razdelek 4.8).
- You can take the tablet at any time of the day either before, during or after a meal.
- Tableto lahko vzamete kadar koli čez dan, pred ali med obrokom ali po njem.
Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
1 tablet.
1 tableta
1: Brache et al, Contraception 2013 §: defined as presence of unruptured dominant follicle five days after late follicular-phase treatment *: compared to levonorgestrel
1: Brache et al, Contraception 2013 §: opredeljena kot prisotnost nerazpočenega dominantnega folikla pet dni po jemanju zdravila v pozni folikularni fazi *: v primerjavi z levonorgestrelom
Among the women who received ellaOne in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.
Od vseh žensk, ki so prejemale zdravilo ellaOne v študiji III. faze, jih je le 0,4 % poročalo o močni krvavitvi v času med dvema menstruacijama.
There is some evidence that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.
Obstaja nekaj dokazov, da se lahko učinkovitost tega zdravila zmanjša s povečano telesno maso ali indeksom telesne mase (ITM), vendar so ti podatki omejeni in nedokončni.
In a majority of cases (88.2%), this bleeding was reported as spotting.
V večini primerov (88,2 %) je bila krvavitev zelo šibka.
- If you are using one of the medicines that may prevent ellaOne from working properly (see section 2 “What you need to know before you take ellaOne”) or if you have used one of these medicines in the past 4 weeks, ellaOne may work less effectively for you.
- Če uporabljate eno od zdravil, ki lahko prepreči pravilno delovanje zdravila ellaOne (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo ellaOne«) ali če ste uporabili eno od teh zdravil v zadnjih 4 tednih, lahko zdravilo ellaOne pri vas deluje manj učinkovito.
Sharing your information may help women in the future understand the safety or risks of ellaOne during a pregnancy.
S sporočanjem podatkov lahko pomagate ženskam v prihodnosti razumeti varnost ali tveganja, povezana z uporabo zdravila ellaOne med nosečnostjo.
Randomised controlled trial
Randomizirano kontrolirano preskušanje
Ulipristal acetate is not a substrate for either OATP1B1 or OATP1B3.
Ulipristalacetat ni substrat za OATP1B1 ali OATP1B3.
LABORATOIRE HRA PHARMA
Malta Laboratoire HRA Pharma
Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if a woman has stopped taking an enzyme inducer in the past 4 weeks.
Indukcija encimov pojema postopoma, učinki na plazemske koncentracije ulipristalacetata pa se lahko pojavijo, tudi če je ženska prenehala jemati induktor encimov v preteklih 4 tednih.
Carcinogenicity studies (in rats and mice) showed that ulipristal acetate is not carcinogenic.
Študije kancerogenosti (na podganah in miših) so pokazale, da ulipristalacetat ni kancerogen.
As a result, this medicine works by postponing ovulation.
To zdravilo torej deluje tako, da odloži ovulacijo.
After the tablet intake menstrual periods can sometimes occur a few days earlier or later than expected.
Po zaužitju tablete lahko menstruacija včasih nastopi nekaj dni prej ali pozneje od predvidenega datuma.
This is because the sperm can survive up to 5 days in your body after intercourse.
Semenčice lahko namreč preživijo v vašem telesu tudi do 5 dni po spolnem odnosu.
The delay was greater than 20 days in 4 % of the women.
Ta zamuda je bila pri 4 % žensk večja od 20 dni.
As with any pregnancy, the possibility of an ectopic pregnancy should be considered.
Kot pri vsaki nosečnosti je treba upoštevati možnost zunajmaternične nosečnosti.
A post-marketing observational study evaluating efficacy and safety of ellaOne in adolescents aged 17 and younger showed no difference in the safety and efficacy profile compared to adult women aged 18 and older.
Opazovalna študija v obdobju trženja, v kateri so ocenili učinkovitost in varnost zdravila ellaOne pri mladostnicah, starih 17 let in mlajših, ni pokazala razlik v profilu varnosti in učinkovitosti v primerjavi z odraslimi ženskami, starimi 18 let in več.
When the data from the two trials were combined via meta- analysis, the risk of pregnancy with ulipristal acetate was significantly reduced compared to levonorgestrel (p=0.046).
Ko so primerjali podatke iz obeh preskušanj z meta-analizo se je izkazalo, da je bila rizičnost nosečnosti pri uporabi ulipristalacetata signifikantno znižana v primerjavi z uporabo levonorgestrela (p=0,046).