FrancophonIA/ELRC3.0 huggingface dataset:
English: On 16 January 2014 the Swedish Agency sent a notification for a referral under Article 31 of directive 2001/83 EC regarding all emergency contraceptives containing LNG or UPA asking the CHMP to give its opinion on whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Slovenian: Švedska agencija je dne 16. januarja 2014 poslala obvestilo o napotitvi v skladu s členom 31Direktive 2001/83/ES za vse urgentne kontraceptive, ki vsebujejo LNG ali UPA, in zaprosila odbor CHMP, da poda mnenje o tem, ali naj se dovoljenja za promet z njimi ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: While the analyses of data from the three randomised controlled trials in which 2,098 women received UPA indicate a weak effect of body weight or BMI on pregnancy rates, the open label study (n=1,241) indicated no such effect.
Slovenian: Medtem ko so analize podatkov iz treh randomiziranih kontroliranih preskušanj, v katerih je 2 098 žensk prejemalo UPA, pokazale majhen vpliv telesne mase ali ITM na stopnje nosečnosti, odprta študija (n = 1 241) ni pokazala tovrstnega vpliva.
English: This is reflected in the wide range of estimates of prevented fraction across different studies.
Slovenian: To se odraža v zelo različnih ocenah deleža preprečenih nosečnosti zaradi samega kontraceptiva v različnih študijah.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for the emergency contraceptive medicinal products containing LNG or UPA.
Slovenian: • odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za urgentne kontraceptive, ki vsebujejo LNG ali UPA;
English: The products are indicated for emergency contraception within 72 hours (3 days) of unprotected sexual intercourse or contraceptive failure, and have been approved in more than 100 countries worldwide and used for more than 30 years.
Slovenian: Kontraceptivi so indicirani za urgentno kontracepcijo v 72 urah (3 dneh) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji, pri čemer so odobreni v več kot 100 državah po celem svetu in se uporabljajo že več kot 30 let.
English: Dada OA et al. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
Slovenian: A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
English: Ulipristal acetate (UPA) (30 mg) (ellaOne) is an orally synthetic progesterone receptor modulator, which acts via high affinity binding to the human progesterone receptor.
Slovenian: Ulipristalacetat (UPA) (30 mg) (ellaOne) je peroralni sintetični modulator progesteronskih receptorjev, ki deluje tako, da se z visoko afiniteto veže na človeški progesteronski receptor.
English: Considering the need to further characterise this risk, the MAHs are strongly recommended to investigate the pharmacodynamic effect (ovulation inhibition) of LNG in obese women in the future.
Slovenian: Glede na potrebo po nadaljnji opredelitvi tega tveganja je zelo priporočljivo, da imetniki dovoljenja za promet z zdravilom v prihodnosti raziščejo farmakodinamični učinek (zaviranje ovulacije) LNG pri debelih ženskah.
English: All together, the current data are considered not robust enough to support the current recommendation of decreased efficacy in women with body weight above 75 kg and inefficacy in women with body weight above 80 kg as is currently included in the product information of one LNG-containing emergency contraceptive medicinal product (Norlevo).
Slovenian: Na splošno je bilo ocenjeno, da trenutni podatki niso dovolj prepričljivi, da bi lahko podprli sedanjo navedbo o manjši učinkovitosti pri ženskah s telesno maso več kot 75 kg in neučinkovitosti pri ženskah s telesno maso več kot 80 kg, ki je trenutno vključena v informacije o zdravilu za enega od urgentnih kontraceptivov, ki vsebujejo LNG (Norlevo).
English: Overall summary of the scientific evaluation of emergency contraceptives medicinal products containing levonorgestrel or ulipristal acetate
Slovenian: Splošni povzetek znanstvenega vrednotenja urgentnih kontraceptivov, ki vsebujejo levonorgestrel ali ulipristalacetat
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili
English: Emergency contraceptives can be used to prevent an unintended pregnancy following an unprotected sexual intercourse or in case of failure of a contraceptive method.
Slovenian: Urgentni kontraceptivi se lahko uporabljajo za preprečevanje nenačrtovane nosečnosti po nezaščitenem spolnem odnosu ali kadar kontracepcijsko sredstvo ni bilo učinkovito.
English: Available data should be included in the product information, but no restrictions of use based on body weight/BMI are recommended at this stage.
Slovenian: Razpoložljivi podatki morajo biti vključeni v informacije o zdravilu, omejitve uporabe na podlagi telesne mase/ITM pa se trenutno ne priporočajo;
English: A range of different factors have an impact on a woman´s fertility and the ability of emergency contraceptives to prevent a pregnancy, e.g. timing of intake of emergency contraception in relation to intercourse, conception probability, further acts of unprotected intercourse, age, ethnicity, previous infections of the genital tract, male fertility, etc.
Slovenian: Na plodnost ženske in zmožnost urgentnega kontraceptiva, da prepreči nosečnost, vpliva več različnih dejavnikov, med katerimi so čas zaužitja urgentnega kontraceptiva po spolnem odnosu, verjetnost zanositve, nadaljnji nezaščiteni spolni odnosi, starost, narodnost, okužbe spolovil v preteklosti, plodnost moškega itd.
English: The use of emergency contraception is an occasional method that is far less effective compared with most contraceptive products used on a regular basis, e.g. combined hormonal contraceptives, gestagen-only pills and various long-acting methods like intra-uterine devices and implants.
Slovenian: Urgentni kontraceptiv je sredstvo, ki se uporabi občasno in je veliko manj učinkovito od večine kontraceptivov, ki se uporabljajo redno - to so na primer kombinirani hormonski kontraceptivi, tablete, ki vsebujejo samo gestagen, in različna dolgo delujoča sredstva, kot so intrauterini vložki in vsadki.
English: The product is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Slovenian: Zdravilo je indicirano za urgentno kontracepcijo v 120 urah (5 dneh) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
English: In particular, limited but inconclusive data suggest that there may be reduced efficacy of these medicinal products with increased body weight in women.
Slovenian: Zlasti je treba upoštevati, da omejeni, vendar neprepričljivi podatki kažejo, da bi bila lahko učinkovitost teh zdravil pri ženskah s povečano telesno maso manjša.
English: • The CHMP concluded that the available data is limited and does not support a definite conclusion that increased bodyweight reduces efficacy of emergency contraceptives medicinal products containing LNG or UPA.
Slovenian: • odbor CHMP je zaključil, da so razpoložljivi podatki omejeni in ne omogočajo dokončnega zaključka, da povečana telesna masa zmanjša učinkovitost urgentnih kontraceptivov, ki vsebujejo LNG ali UPA.
English: The data are currently too limited and therefore insufficiently precise to draw definite conclusions whether efficacy is negatively influenced by increased body weight and BMI; for instance for the obese category (BMI ≥30) three pregnancies were reported in the first analysis, and eleven pregnancies in the second.
Slovenian: Podatki so trenutno preveč omejeni in zato premalo natančni, da bi omogočali dokončne zaključke o tem, ali večja telesna masa in višji ITM negativno vplivata na učinkovitost; pri debelih ženskah (ITM ≥ 30) so na primer v prvi analizi zabeležili tri nosečnosti, v drugi pa enajst.
English: A trend was observed in the UPA group for increasing number of pregnancies with increasing weight or BMI.
Slovenian: V skupini z UPA so opazili, da je število nosečnosti naraščalo z večjo telesno maso oziroma višjim ITM.
English: Eight relevant studies with LNG-containing emergency contraceptives are available in public literature.
Slovenian: V objavljeni literaturi je na voljo osem pomembnih študij o urgentnih kontraceptivih, ki vsebujejo LNG.
English: This information should also be reflected in the package leaflet.
Slovenian: Prav tako je te informacije treba vključiti v navodilo za uporabo.
English: In contrast, in the two comparative studies of Creinin and colleagues (2006) and Glasier and colleagues (2010), primarily including Caucasian women, a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table 2).
Slovenian: Nasprotno pa so v dveh primerjalnih študijah, ki so ju opravili Creinin in sodelavci (2006) ter Glasier in sodelavci (2010) in ki sta v glavnem zajeli belke, pri večji telesni masi ali višjem ITM opazili manjšo kontracepcijsko učinkovitost (razpredelnica 2).
English: The emergency contraceptives can be divided into levonorgestrel (LNG)- and ulipristal acetate (UPA)-containing emergency contraceptives and they act by inhibiting and/or delaying ovulation.
Slovenian: Razdelimo jih lahko na urgentne kontraceptive, ki vsebujejo levonorgestrel (LNG), in urgentne kontraceptive, ki vsebujejo ulipristalacetat (UPA), delujejo pa tako, da zavirajo in/ali zakasnijo ovulacijo.
English: Therefore, even if data from some studies suggest a lower ability of LNG-containing emergency contraceptives to prevent pregnancies in women of higher weight/BMI, this is only one factor influencing the effect and it is difficult to define a certain cut-off for weight/BMI at which no effect is present.
Slovenian: Čeprav torej podatki iz nekaterih študij kažejo, da imajo urgentni kontraceptivi, ki vsebujejo LNG, manjšo sposobnost preprečitve nosečnosti pri ženskah z večjo telesno maso/višjim ITM, je to le eden od dejavnikov, ki vplivajo na učinek, poleg tega pa je težko opredeliti določeno mejno vrednost telesne mase/ITM, pri kateri ni učinka.
English: In addition the CHMP is of the opinion that conducting a pharmacodynamic/pharmacokinetic (PD/PK) study may provide some information which may help to further characterise the risk of decreased efficacy in women with high body weight/BMI and ovulation inhibition.
Slovenian: Poleg tega je odbor CHMP menil, da bi z izvedbo farmakodinamične/farmakokinetične študije lahko pridobili določene podatke, ki bi lahko pomagali pri nadaljnji opredelitvi tveganja za manjšo učinkovitost pri ženskah z veliko telesno maso/visokim ITM in zaviranja ovulacije.
English: In the three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) no trend for a reduced efficacy with increasing body weight/BMI was observed, whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI.
Slovenian: V treh študijah SZO (Von Hertzen et al., 1998 in 2002; Dada et al., 2010) niso opazili manjše učinkovitosti pri večji telesni masi/višjem ITM, v dveh drugih študijah (Creinin et al., 2006 in Glasier et al., 2010) pa so opazili manjšo kontracepcijsko učinkovitost pri povečani telesni masi ali višjem ITM.
English: In the meta-analysis including the three WHO studies, primarily including African and Asian women, no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 1).
Slovenian: V metaanalizi, ki je zajela tri študije SZO, v katere so v glavnem vključili ženske afriškega in azijskega porekla, niso opazili, da bi bila učinkovitost pri večji telesni masi/višjem ITM manjša (razpredelnica 1).
English: During the data submission an analysis was provided on three WHO studies (Von Hertzen et al., 1998 1 and 2002 2; Dada et al., 2010 3) as well as an analysis on two other studies (Creinin et al., 2006 4; Glasier et al., 2010 5).
Slovenian: Ob predložitvi podatkov je bila posredovana analiza treh študij SZO (Von Hertzen et al., 1998 1 in 2002 2; Dada et al., 2010 3) ter tudi analiza dveh drugih študij (Creinin et al., 2006 4; Glasier et al., 2010 5).
English: N pregnancies 1
Slovenian: Št. nosečnosti
English: From these data there is no clear indication of an effect of weight or BMI on efficacy in general, or specifically among overweight or obese women.
Slovenian: Glede na te podatke ni jasnega dokaza, da telesna masa ali ITM vplivata na učinkovitost pri splošni populaciji niti samo pri ženskah s čezmerno telesno maso ali debelih ženskah.
English: The data are currently too limited and therefore insufficiently precise to draw definite conclusions whether efficacy is negatively influenced by increased body weight and BMI.
Slovenian: Podatki so trenutno preveč omejeni in zato premalo natančni, da bi omogočali dokončne zaključke o tem, ali večja telesna masa in višji ITM negativno vplivata na učinkovitost.
English: Further, since the limited data available do not support with any certainty the conclusion that their contraceptive effect is reduced in women with high bodyweight, no adjustment of the dose is recommended at this stage, and any information that already is included in the section 4.2 of the SmPC making reference to effect and body weight should be removed.
Slovenian: Ker omejeni podatki, ki so na voljo, ne omogočajo zanesljivega zaključka, da je kontracepcijska učinkovitost pri ženskah z veliko telesno maso manjša, se trenutno ne priporoča nikakršno prilagajanje odmerka, vse informacije v zvezi z učinkom in telesno maso, ki so že vključene v poglavje 4.2 povzetka glavnih značilnosti zdravila, pa je treba izbrisati.
English: Both meta-analyses excluded off-label use of LNG-containing of emergency contraceptives, i.e. intake later than 72 hours after unprotected intercourse and women who had further acts of unprotected intercourse.
Slovenian: Iz obeh metaanaliz so izključili nenamensko uporabo urgentnih kontraceptivov, ki vsebujejo LNG, tj. uporabo več kot 72 ur po nezaščitenem spolnem odnosu, in ženske, ki so imele nadaljnje nezaščitene spolne odnose.
English: For UPA-containing emergency contraceptive products (ellaOne) it is concluded that limited and inconclusive data suggest that there may be reduced efficacy of UPA with increased body weight in women.
Slovenian: V zvezi z urgentnimi kontraceptivi, ki vsebujejo UPA (ellaOne), je bilo zaključeno, da omejeni in neprepričljivi podatki kažejo, da bi učinkovitost UPA pri ženskah z večjo telesno maso lahko bila manjša.
English: • The Committee reviewed all data from clinical studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs), on the efficacy of emergency contraceptive medicinal products containing LNG or UPA, in particular with regards to a possible effect of high weight/BMI of women.
Slovenian: • odbor je pregledal vse podatke iz kliničnih študij, objavljene literature in izkušenj v obdobju trženja, vključno z odgovori, ki so jih podali imetniki dovoljenja za promet z zdravilom, v zvezi z učinkovitostjo urgentnih kontraceptivov, ki vsebujejo LNG ali UPA, zlasti v povezavi z morebitnim vplivom velike telesne mase/visokega ITM žensk;
English: Further, the data of the metaanalysis should be presented in section 5.1 of the SmPC.
Slovenian: Poleg tega je treba v poglavje 5.1 povzetka glavnih značilnosti zdravila vključiti podatke iz metaanalize.
English: The CHMP reviewed all data from clinical studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs), on the efficacy of emergency contraceptive medicinal products containing LNG or UPA, in particular with regards to the relation of high weight/BMI of women.
Slovenian: Odbor CHMP je pregledal vse podatke iz kliničnih študij, objavljene literature in izkušenj v obdobju trženja, vključno z odgovori, ki so jih podali imetniki dovoljenja za promet z zdravilom, v zvezi z učinkovitostjo urgentnih kontraceptivov, ki vsebujejo LNG ali UPA, zlasti v povezavi z veliko telesno maso/visokim ITM žensk.
English: excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of LNG) and women who had further acts of unprotected intercourse.
Slovenian: Iz obeh metaanaliz so bili izključeni vnosi več kot 72 ur po nezaščitenem spolnem odnosu (tj. nenamenska uporaba LNG) in ženske, ki so imele nadaljnje nezaščitene spolne odnose.
English: The CHMP proposed that a warning in section 4.4 of the summary of product characteristics (SmPC) is an appropriate routine risk minimisation measure to reflect that limited and inconclusive data are present regarding a possible reduced efficacy in women with a high body weight/BMI.
Slovenian: Odbor CHMP je kot primeren rutinski ukrep za zmanjšanje tveganja predlagal opozorilo v poglavju 4.4 povzetka glavnih značilnosti zdravila (SmPC), ki bo opozarjalo na to, da so v zvezi z morebitno manjšo učinkovitostjo pri ženskah z veliko telesno maso/visokim ITM na voljo omejeni in neprepričljivi podatki.
English: Table 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010
Slovenian: Razpredelnica 2: Metaanaliza študij, ki so ju opravili Creinin et al. (2006) ter Glasier et al. (2010)
English: The CHMP concluded that a warning in section 4.4 of the SmPC is appropriate to indicate that limited and inconclusive data are present regarding a possible reduced efficacy in women with a high body weight/BMI and that in all women emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
Slovenian: Odbor CHMP je zaključil, da je v poglavje 4.4 povzetka glavnih značilnosti zdravila primerno vključiti opozorilo, da so glede morebitne manjše učinkovitosti pri ženskah z veliko telesno maso/visokim ITM na voljo omejeni in neprepričljivi podatki ter da morajo vse ženske urgentni kontraceptiv vzeti čim prej po nezaščitenem spolnem odnosu, ne glede na njihovo telesno maso ali ITM.
English: Further, the data of the two meta-analyses should be reflected in section 5.1 of the SmPC.
Slovenian: Poleg tega je treba v poglavje 5.1 povzetka glavnih značilnosti zdravila vključiti podatke iz obeh metaanaliz.
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) BMI (kg/m2)
Slovenian: Razpredelnica 1: Metaanaliza treh študij SZO (Von Hertzen et al., 1998 in 2002; Dada et al., 2010)
English: The CHMP was requested to assess whether the efficacy of emergency contraceptives is affected in relation to body weight and/or body mass index (BMI) of the women.
Slovenian: Odbor CHMP je bil zaprošen, da oceni, ali telesna masa in/ali indeks telesne mase (ITM) žensk vplivata na učinkovitost urgentnih kontraceptivov.
English: • The Committee considered that in view of the currently available data, the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA is favourable, subject to warnings and other changes to the product information.
Slovenian: • odbor je na podlagi vseh trenutno razpoložljivih podatkov zaključil, da je razmerje med tveganji in koristmi urgentnih kontraceptivov, ki vsebujejo LNG ali UPA, ugodno pod pogojem, da se upoštevajo opozorila in druge spremembe informacij o zdravilu.
English: The Committee concluded that the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA remains positive for all women regardless of body weight/BMI, subject to the warnings and changes to the product information agreed.
Slovenian: Odbor je zaključil, da je razmerje med tveganji in koristmi urgentnih kontraceptivov, ki vsebujejo LNG ali UPA, še naprej pozitivno za vse ženske ne glede na telesno maso/ITM, pod pogojem, da se upoštevajo dogovorjena opozorila in spremembe informacij o zdravilu.
English: 2 von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO
Slovenian: Lancet, 1998; 352: 428-33. 2 von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO
English: Grounds for the variation to the terms of the marketing authorisation Whereas
Slovenian: Podlaga za spremembo pogojev dovoljenja za promet z zdravilom
English: The Committee, as a consequence, concluded that the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA remains positive, subject to the warnings and changes to the product information agreed.
Slovenian: Odbor je zato zaključil, da je razmerje med tveganji in koristmi urgentnih kontraceptivov, ki vsebujejo LNG ali UPA, še naprej pozitivno pod pogojem, da se upoštevajo dogovorjena opozorila in spremembe informacij o zdravilu.
English: Overall for of LNG-containing emergency contraceptives it is concluded that there is limited data on the effect of high body weight/high BMI on the contraceptive efficacy.
Slovenian: Na splošno je bilo v zvezi z urgentnimi kontraceptivi, ki vsebujejo LNG, zaključeno, da so podatki o vplivu velike telesne mase/visokega ITM na kontracepcijsko učinkovitost omejeni.
English: For LNG-containing emergency contraceptives overall it is concluded that there is limited and inconsistent data on the effect of high body weight/high BMI on the contraceptive efficacy.
Slovenian: Na splošno je bilo v zvezi z urgentnimi kontraceptivi, ki vsebujejo LNG, zaključeno, da so podatki o vplivu velike telesne mase/visokega ITM na kontracepcijsko učinkovitost omejeni in nedosledni.
English: The information in the SmPC should also be reflected in the package leaflet.
Slovenian: Informacije v povzetku glavnih značilnosti zdravila je treba vključiti tudi v navodilo za uporabo.
English: N total N pregnancies 0
Slovenian: Št. nosečnosti Stopnja nosečnosti Interval zaupanja
English: There are limited and inconclusive data from clinical trials that evaluated the effect of high body weight/high BMI on the contraceptive efficacy.
Slovenian: Podatki iz kliničnih preskušanj, v katerih so vrednotili vpliv velike telesne mase/visokega ITM na kontracepcijsko učinkovitost, so omejeni in neprepričljivi.
English: N total
Slovenian: Priloga II
English: This summary was last updated in 10-2017.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2017.
English: The third study involved 59 children aged two to 12 years.
Slovenian: Tretja študija je vključevala 59 otrok, starih od 2 do 12 let.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nuwiq on 24 July 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nuwiq, veljavno po vsej Evropski uniji, izdala 24. julija 2014.
English: The main measure of effectiveness was based on patients' assessment of how well treatment worked.
Slovenian: Glavno merilo učinkovitosti je temeljilo na oceni, ki so jo podali bolniki glede učinkovitosti delovanja zdravila.
English: In such cases, a specialised haemophilia centre should be contacted.
Slovenian: V takem primeru se je treba obrniti na specializirani center za hemofilijo.
English: Nuwiq simoctocog alfa
Slovenian: Nuwiq simoktokog alfa
English: The full EPAR for Nuwiq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nuwiq je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Nuwiq.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nuwiq.
English: Nuwiq is intended for either short-term or long-term use.
Slovenian: Zdravilo Nuwiq je namenjeno za kratkotrajno ali dolgotrajno uporabo.
English: What measures are being taken to ensure the safe and effective use of Nuwiq?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nuwiq?