FrancophonIA/ELRC3.0 huggingface dataset:
English: Minutes from the 73rd meeting, held on 6 October 2011
Slovenian: Zapisnik 73. seje, ki je potekala 6. oktobra 2011
English: [EMA/MB/903626/2011; EMA/688885/2010; EMA/161137/2011] The Management Board endorsed the new framework for interaction with healthcare professionals (HCPs) and the criteria that apply to HCP organisations wishing to be involved in the Agency's activities.
Slovenian: [EMA/MB/903626/2011; EMA/688885/2010; EMA/161137/2011] Upravni odbor je potrdil nov okvir za sodelovanje z zdravstvenimi delavci in merila, ki se uporabljajo za organizacije zdravstvenih delavcev,
English: [EMA/MB/143451/2011] The Board adopted the Agency's budget and the establishment plan for 2012.
Slovenian: [EMA/MB/143451/2011] Upravni odbor je sprejel proračun in kadrovski načrt agencije za leto 2012.
English: [EMA/MB/886045/2011; EMA/121340/2011] The Management Board endorsed the reflection paper.
Slovenian: [EMA/MB/886045/2011; EMA/121340/2011] Upravni odbor je potrdil študijo.
English: [EMA/907384/2011] The Management Board adopted a change to the terms of reference of the Committee.
Slovenian: [EMA/907384/2011] Upravni odbor je sprejel spremembo pristojnosti in nalog odbora.
English: a.) Revised terms of reference
Slovenian: a) Spremenjene pristojnosti in naloge
English: EMA/MB/33634/2012 Adopted Management Board
Slovenian: EMA/511072/2012 Sprejet Upravni odbor
English: Representative of veterinarians' organisations
Slovenian: Predstavnik veterinarskih organizacij
English: 4 Cyprus by proxy
Slovenian: 4 Ciper po pooblaščencu
English: Report from the Heads of Medicines Agencies (HMA)
Slovenian: Poročilo vodij agencij za zdravila
English: The European Commission stated the importance of not raising expectations among the public in view of the resource constraints; the Commission will look at what can be addressed in the revision of the Clinical Trials Directive.
Slovenian: Evropska komisija je poudarila, da se zaradi omejenosti sredstev ne smejo povečati pričakovanja javnosti.
English: Luxembourg by proxy
Slovenian: Luksemburg po pooblaščencu
English: 12 Latvia
Slovenian: 11 Italija
English: 7bis Personnel matter
Slovenian: Kadrovska zadeva
English: 300 mg Concentrate for solution for infusion
Slovenian: 300 mg koncentrat za raztopino za infundiranje intravenska uporaba viala (steklo)
English: Oral suspension Oral use bottle (glass)
Slovenian: 40 mg/ml peroralna suspenzija peroralna uporaba steklenička (steklo)
English: Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Slovenian: Znanstveni zaključki in podlaga za zavrnitev, ki jih je predstavila Evropska agencija za zdravila
English: • The Committee considered all the available data submitted from efficacy and safety.
Slovenian: • Odbor je upošteval vse predložene podatke, povezane z učinkovitostjo in varnostjo;
English: Acne affects more than 50% of teenagers but frequently continues into adulthood.
Slovenian: Akne prizadenejo več kot 50 % najstnikov in se pogosto nadaljujejo tudi v odrasli dobi.
English: b) the potential use of the product for women who are not comprised in the target population.
Slovenian: b) možnosti, da bi zdravilo uporabljale ženske, ki niso del ciljne populacije;
English: On 28 June 2011 and 29 June 2011 Italy and Sweden respectively, triggered a referral under Article 6(12) of Commission Regulation EC No 1084/2003.
Slovenian: Italija in Švedska sta 28. junija 2011 oziroma 29. junija 2011 sprožili napotitveni postopek v skladu s členom 6(12) Uredbe Komisije ES št. 1084/2003.
English: Therefore the Committee concluded that the variation application should be refused.
Slovenian: Zato je zaključil, da je vlogo za spremembo treba zavrniti.
English: The specific content of the proposed educational program was to be agreed with the national competent authorities following the authorisation of the combined indication.
Slovenian: O natančni vsebini predlaganega izobraževalnega programa naj bi se po odobritvi kombinirane indikacije dogovoril s pristojnimi nacionalnimi organi.
English: • The Committee considered the procedure under Article 6(12) of Commission Regulation (EC) no 1084/2003, for Ethinylestradiol-Drospirenone 24+4 and associated names initiated by Italy and Sweden.
Slovenian: • Odbor je obravnaval postopek v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003 za zdravilo Ethinylestradiol-Drospirenone 24+4 in povezana imena, ki sta ga sprožili Italija in Švedska.
English: Risk Minimisation Measures
Slovenian: Ukrepi za obvladovanje tveganja
English: Overall summary of the scientific evaluation of Ethinylestradiol-Drospirenone 24+4 and associated names (see annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Ethinylestradiol-Drospirenone 24+4 in povezanih imen (glejte Prilogo I)
English: The mean age at presentation for treatment is 24 years, with 10% of treatment visits taking place when patients are between the ages of 35 and 44 years.
Slovenian: Povprečna starost pri prvem posvetovanju o zdravljenju je 24 let, medtem ko se 10 % bolnikov začne zdraviti med 35. in 44. letom starosti.
English: Overall benefit-risk assessment
Slovenian: Splošna ocena koristi in tveganja
English: Namely, the educational program and the drug utilization studies proposed to monitor the effectiveness of the measures.
Slovenian: V izobraževalnem programu in študijah uporabe zdravila je bilo namreč predlagano preverjanje učinkovitosti ukrepov.
English: This treatment does not exempt patients from specific acne treatment if necessary.” in section 4.1 “Therapeutic Indications” of the Summary of Product Characteristics (SmPC).
Slovenian: To zdravljenje ne izključuje zdravljenja bolnic s specifičnimi zdravili proti aknam, če je to potrebno.“ v poglavju 4.1 „Terapevtske indikacije“ povzetka glavnih značilnosti zdravila.
English: In addition, and in order to monitor the effectiveness of the educational program with the consequent monitoring of the EE/DRSP-COCs prescribing practices in Europe, two drug utilization studies were proposed.
Slovenian: Poleg tega je za namen preverjanja učinkovitosti izobraževalnega programa s posledičnim preverjanjem prakse predpisovanja kombiniranih peroralnih kontracepcijskih sredstev z etinilestradiolom/drospirenonom v Evropi predlagal dve študiji uporabe zdravila.
English: The social, psychological, and emotional impairment that can result from acne has been reported to be similar to that associated with epilepsy, asthma, diabetes, and arthritis.
Slovenian: Po poročilih je mogoče poslabšanje v socialnem, psihološkem in čustvenem smislu kot posledica aken primerljivo s tistim pri epilepsiji, astmi, sladkorni bolezni in artritisu.
English: These Member States considered the approval of the variation to constitute a serious risk for public health on the basis that the overall risk-benefit profile for Ethinylestradiol-Drospirenone 24+4 in the proposed indication was considered not acceptable in light of:
Slovenian: Ti državi članici sta menili, da bi odobritev spremembe pomenila resno tveganje za javno zdravje na podlagi tega, da je bil splošni profil med koristmi in tveganji zdravila Ethinylestradiol-Drospirenone 24+4 za predlagano indikacijo ocenjen kot nesprejemljiv ob upoštevanju:
English: The population included in the studies is considered representative of the respective target population for the treatment of moderate acne vulgaris.
Slovenian: Populacija, ki je sodelovala v teh študijah, velja za značilno glede na ciljno populacijo za zdravljenje zmernih vulgarnih aken.
English: Thus, the potential to restrict the duration of treatment by the proposed risk minimisation program is not considered realistic or sufficiently effective.
Slovenian: Potencial, da bi predlagani program za obvladovanje tveganja omejil trajanje zdravljenja, naj ne bi bil stvaren ali dovolj učinkovit.
English: The Marketing Authorisation Holder (MAH), Bayer B.V. submitted a type II variation via mutual recognition procedure for Ethinylestradiol-Drospirenone 24+4 and associated names (NL/H/1269, 1270/01/II/006) on 26 January 2009, to request an extension of the indication to include: “Oral contraception for women with moderate acne vulgaris.
Slovenian: Imetnik dovoljenja za promet z zdravilom, Bayer B.V., je 26. januarja 2009 po postopku z medsebojnim priznavanjem predložil vlogo za spremembo tipa II za zdravilo EthinylestradiolDrospirenone 24+4 in povezana imena (NL/H/1269, 1270/01/II/006), s katero je zahteval razširitev indikacije, tako da bi ta vključevala: „Peroralna kontracepcija za ženske z zmernimi vulgarnimi aknami.
English: Venous thromboembolic events (VTEs)
Slovenian: Venski trombembolični dogodki
English: Ethinylestradiol-Drospirenone 24+4 is a combined oral contraceptive (COC) and contains ethinylestradiol 20 µg and the progestogen drospirenone 3 mg (EE/DRSP).
Slovenian: Zdravilo Ethinylestradiol-Drospirenone 24+4 je kombinirano peroralno kontracepcijsko sredstvo, ki vsebuje 20 µg etinilestradiola in 3 mg progestagen drospirenona (EE/DRSP).
English: The classification of acne severity is from mild, moderate, moderately severe to severe depending on the presence of the lesions.
Slovenian: Akne po izrazitosti razvrščamo od blagih, zmernih in zmerno hudih do hudih, odvisno od prisotnosti lezij.
English: In addition, a higher percentage of subjects, 11.8% (18.6% versus 6.8%), showed a ‘clear' or ‘almost clear' rating on the Investigator's Static Global Assessment (ISGA) scale.
Slovenian: Poleg tega je večji delež bolnic, 11,8 % (18,6 % v primerjavi s 6,8 %), dobil oceno „čista koža“ ali „skoraj čista koža“ po lestvici (ISGA).
English: The CHMP recognised the efficacy in the overall lesion count reduction.
Slovenian: Prepoznal je učinkovitost pri zmanjšanju skupnega števila lezij;
English: • The Committee found merit on the concerns raised by the Member States regarding the continuation of use of EE/DRSP in the treatment of moderate acne when contraception is no longer needed for which the benefit/risk balance is not acceptable considering the risk of rare but serious adverse events balanced against the limited clinical benefits.
Slovenian: • Odbor je odobraval pomisleke, ki sta jih sporočili državi članici v zvezi z nadaljevanjem uporabe etinilestradiola/drospirenona za zdravljenje zmernih aken, ko kontracepcija ni več potrebna, pri čemer razmerje med koristmi in tveganji ni sprejemljivo glede na to, da je tveganje za redke, ampak hude neželene učinke združeno z omejeno klinično koristjo.
English: The MAH also committed to further improve and expand the educational program if the prescribing rate for the treatment of moderate acne in women not seeking contraception resulted higher than 10% in both drug utilization studies.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je tudi zavezal k nadaljnji izboljšavi in razširitvi izobraževalnega programa, če bi se v obeh študijah uporabe zdravila izkazalo, da je stopnja predpisovanja za zdravljenje zmernih aken pri ženskah, ki ne potrebujejo kontracepcije, več kot 10-odstotna.
English: Therefore, the CHMP concludes that the variation application does not satisfy the criteria for authorisation and recommends the refusal of the variation to the terms of the Marketing Authorisation for all medicinal product(s) referred to in Annex I.
Slovenian: Zato je odbor CHMP zaključil, da vloga za spremembo ne izpolnjuje meril za odobritev, in priporočil zavrnitev spremembe pogojev dovoljenja za promet z vsemi zdravili, navedenih v Prilogi I.
English: The efficacy results in the treatment of moderate acne derive from two placebo-controlled studies which are included in section 5.1 “Pharmacodynamic data” of the SmPC.
Slovenian: Rezultati učinkovitosti pri zdravljenju zmernih aken izhajajo iz dveh s placebom nadzorovanih študij, vključenih v poglavje 5.1 „Farmakodinamični podatki“ povzetka glavnih značilnosti zdravil.
English: Consequently, the CHMP concluded in accordance with Article 32 (4) of Directive 2001/83/EC that the variation application does not satisfy the criteria for authorisation and recommends the refusal of the variation to the terms of the Marketing Authorisation for Ethinylestradiol-Drospirenone 24+4 and associated names (see Annex I).
Slovenian: je odbor CHMP v skladu s členom 32(4) Direktive 2001/83/ES zaključil, da vloga za spremembo ne izpolnjuje meril za odobritev, ter priporočal zavrnitev spremembe pogojev dovoljenja za promet z zdravilom Ethinylestradiol-Drospirenone 24+4 in povezanimi imeni (glejte Prilogo I).
English: After six months of treatment, in comparison with placebo, EE/DRSP showed a statistically and clinically significant reduction of 15.6% (49.3% versus 33.7%) in inflammatory lesions, 18.5% (40.6% versus 22.1%) in non-inflammatory lesions, and 16.5% (44.6% versus 28.1%) in total lesion counts.
Slovenian: Po šestih mesecih zdravljenja je kombinacija etinilestradiola in drospirenona v primerjavi s placebom pokazala statistično in klinično pomembno 15,6-odstotno (49,3 % v primerjavi s 33,7 %) zmanjšanje vnetnih lezij, 18,5-odstotno (40,6 % v primerjavi z 22,1 %) zmanjšanje nevnetnih lezij in 16,5odstotno (44,6 % v primerjavi z 28,1 %) zmanjšanje skupnega števila lezij.
English: In support of this indication, two (A25083 and A25152) multicenter, double blind, randomised, placebo controlled studies were performed to evaluate the efficacy and safety of EE/DRSP in women with moderate acne vulgaris.
Slovenian: V podporo tej indikaciji so opravili dve (A25083 in A25152) multicentrični, dvojno slepi, randomizirani, s placebom nadzorovani študiji, v katerih so ocenili učinkovitost in varnost uporabe etinilestradiola/drospirenona pri ženskah z zmernimi vulgarnimi aknami.
English: • The Committee noted the overall efficacy of EE/DRSP as a treatment for moderate acne vulgaris in reproductive age women was shown in two placebo-controlled studies.
Slovenian: • Odbor je opazil, da je bila splošna učinkovitost etinilestradiola/drospirenona za zdravljenje zmernih vulgarnih aken pri ženskah v rodni dobi dokazana v dveh s placebom nadzorovanih študijah.
English: Acne is a skin disorder of the sebaceous follicles that presents with lesions that are either inflamed (i.e. papules, pustules and nodules) or non-inflamed (i.e. open- or closed comedones).
Slovenian: Akne so kožna bolezen lojnih mešičkov, ki se kaže kot lezije; te so lahko vnetne (tj. papule, pustule in noduli) ali nevnetne (tj. odprti ali zaprti komedoni).
English: At least four patho-physiologic events take place within acne-infected hair follicles: i) androgenmediated stimulation of sebaceous gland activity, ii) abnormal keratinisation leading to follicular plugging (comedo forming), iii) proliferation of the bacterium Proprioni-bacterium acnes (P. acnes) within the follicle, iv) inflammation.
Slovenian: V lasnih mešičkih, okuženih z aknami, potekajo najmanj štirje patofiziološki procesi: i) stimulacija delovanja žlez lojnic, pri kateri sodelujejo androgeni; ii) nenormalno roženenje, ki vodi v zamašitev mešičkov (in nastanek komedonov); iii) razmnoževanje bakterije Proprioni-bacterium acnes (P. acnes) v notranjosti mešička; iv) vnetje.
English: The most serious risks associated with its treatment are venous thromboembolic events (VTEs) and breast cancer:
Slovenian: Najresnejša tveganja, povezana s tem zdravljenjem, so venski trombembolični dogodki in rak dojke:
English: The prescription guide is expected to have a little impact on adherence to and compliance with the product information.
Slovenian: Ni pričakovati, da bi smernice za predpisovanje pomembno vplivale na upoštevanje informacij o zdravilu in na skladno ravnanje.
English: The mean difference observed in total lesion count reduction is of 16% between EE/DRSP and placebo.
Slovenian: Povprečna razlika, ki so jo opazili v zmanjšanju skupnega števila lezij med kombinacijo etinilestradiola in drospirenona ter placebom, je 16 %.
English: As mentioned above, these results are reflected in the pharmacodynamic data's section of the product information for EE/DRSP- COCs.
Slovenian: Kot je navedeno zgoraj, se ti rezultati odražajo v razdelku o farmakodinamičnih podatkih v informacijah o zdravilu za kombinirana peroralna kontracepcijska sredstva, ki vsebujejo etinilestradiol in drospirenon.
English: The Committee considered that the risk minimisation measures proposed would not ensure that the use of the product would be limited to treatment of moderate acne only in women seeking oral contraception and could not identify other risk minimisation measures which would reduce such risk.
Slovenian: Odbor je menil, da predlagani ukrepi za obvladovanje tveganja ne bi zagotovili, da bi bila uporaba zdravila omejena na zdravljenje zmernih aken samo pri ženskah, ki potrebujejo peroralno kontracepcijo, in tudi ni zmogel opredeliti drugih ukrepov, ki bi to tveganje zmanjšali.
English: Based on the above, the Committee is of the opinion that the inclusion of treatment of acne vulgaris in the indication may increase unnecessarily the use of EE/DRSP relatively to safer combined oral contraceptive and that minimisation measures that could ensure an acceptable risk level in this clinical situation could not be identified.
Slovenian: Na podlagi zgoraj navedenega je Odbor sprejel mnenje, da bi vključitev zdravljenja vulgarnih aken v indikacijo lahko po nepotrebnem povečala uporabo kombinacije etinilestradiola in drospirenona v primerjavi z varnejšim kombiniranim peroralnim kontracepcijskim sredstvom ter da ni mogoče opredeliti ukrepov za zmanjševanje tveganja, ki bi v teh kliničnih okoliščinah lahko zagotovili njegovo sprejemljivo raven.
English: Scarring can lead to lifelong problems in regard to self-esteem.
Slovenian: Težave s samozavestjo, povezane z nastankom brazgotin, lahko trajajo vse življenje.
English: In addition, the dual need for treatment of acne while the patient will also need oral contraception will exist at time of prescribing.
Slovenian: Poleg tega bo dvojna potreba po zdravljenju aken in uporabi peroralne kontracepcije obstajala v času, ko bo zdravilo predpisano.
English: These were regarded as not sufficient to ensure the safe and effective use of EE/DRSP in the specific clinical situation.
Slovenian: Ti so bili ocenjeni kot nezadostni za zagotovitev varne in učinkovite uporabe kombinacije etinilestradiola in drospirenona v specifičnih kliničnih okoliščinah v praksi.
English: Considering all the above and the fact that acne is a very common condition in young women, the Committee raised concerns that a beneficial effect noted by the patient from use of EE/DRSP would reduce the motivation to stop the intake when the need for contraception ceases and, therefore, it would not be possible to ensure that the use of the medicinal product would be limited to the treatment of moderate acne vulgaris only in women seeking oral contraception.
Slovenian: Ob upoštevanju vsega naštetega ter dejstva, da so akne pri mladih ženskah zelo pogosta bolezen, je Odbor izrazil zadržek, da bi koristen učinek, ki bi ga opazila bolnica ob uporabi kombinacije etinilestradiola in drospirenona, zmanjšal njeno motivacijo za prenehanje jemanja, ko ne bi več potrebovala kontracepcije; zato ne bi bilo mogoče zagotoviti, da bi bila uporaba zdravila omejena na zdravljenje zmernih vulgarnih aken samo pri ženskah, ki potrebujejo peroralno kontracepcijo.
English: This was corroborated by case-control studies that showed consistent results with a 2 to 3-fold greater risk for drospirenone versus LNGcontaining OCs.
Slovenian: To so dopolnile študije primerov, ki so pokazale dosledne rezultate z od 2- do 3-krat večjim tveganjem pri uporabi drospirenona v primerjavi s peroralnimi kontracepcijskimi sredstvi, ki vsebujejo levonorgestrel.
English: The overall efficacy of EE/DRSP as a treatment for moderate acne vulgaris in reproductive age women was shown in the two placebo-controlled A25083 and A25152 studies.
Slovenian: Splošno učinkovitost etinilestradiola/drospirenona za zdravljenje zmernih vulgarnih aken pri ženskah v rodni dobi so dokazali z dvema s placebom nadzorovanima študijama, A25083 in A25152.
English: This is of concern as the risk of venous thromboembolism for drospirenone-containing OCs is higher (approximately 2-fold) than for levonorgestrel-containing OCs.
Slovenian: To je skrb vzbujajoče, saj je pri peroralnih kontracepcijskih sredstvih, ki vsebujejo drospirenon, tveganje za venski trombembolizem večje (za približno 2-krat) kot pri peroralnih kontracepcijskih sredstvih, ki vsebujejo levonorgestrel.
English: The overall efficacy assessment of EE/DRSP as a treatment for moderate acne vulgaris in reproductive age women observed during studies A25083 and A25152 demonstrates statistically significant responses to treatment with EE/DRSP as compared to placebo in all four primary efficacy variables (inflammatory lesion, non-inflammatory lesion, and total lesion counts, and women with a ‘clear' or ‘almost clear' rating on the ISGA scale) and the majority of secondary efficacy variables (papules, pustules, closed and open comedones).
Slovenian: Ocena splošne učinkovitosti etinilestradiola/drospirenona kot zdravljenja zmernih vulgarnih aken pri ženskah v rodni dobi, opažene v študijah A25083 in A25152, je pokazala statistično pomembne odzive na zdravljenje z etinilestradiolom/drospirenonom v primerjavi s placebom pri vseh štirih primarnih spremenljivkah učinkovitosti (vnetna lezija, nevnetna lezija in skupno število lezij ter ženske z oceno „čista koža“ ali „skoraj čista koža“ po lestvici ISGA) ter pri večini sekundarnih spremenljivk učinkovitosti (papule, pustule, zaprti in odprti komedoni).
English: General tools (e.g. lectures, conferences, symposia) targeting health care providers were proposed as educational material for prescribers by emphasising on the benefit/risk of EE/DRSP use in targeted population and discourage off-label use as well as to highlight to the patients that treatment of moderate acne with EE/DRSP is limited to patients who indeed require hormonal contraception.
Slovenian: Kot izobraževalno gradivo za zdravnike, ki bodo zdravilo predpisovali, so bila predlagana splošna sredstva (npr. predavanja, konference, simpoziji), namenjena zdravstvenim delavcem, s poudarkom na razmerju med koristmi in tveganji uporabe etinilestradiola/drospirenona pri ciljni populaciji, odvračanju od izjemne uporabe in svetovanju bolnicam, da je zdravljenje zmernih aken z etinilestradiolom/drospirenonom omejeno na tiste, ki dejansko potrebujejo hormonsko kontracepcijo.
English: Statistically significant responses to treatment with EE/DRSP as compared to placebo was seen in all four primary efficacy variables (inflammatory lesion, non-inflammatory lesion, and total lesion counts, and women with a ‘clear' or ‘almost clear' rating on the ISGA scale).
Slovenian: Statistično pomemben odziv na zdravljenje z etinilestradiolom/drospirenonom v primerjavi s placebom so opazili pri vseh štirih primarnih spremenljivkah učinkovitosti (vnetna lezija, nevnetna lezija in skupno število lezij ter ženske z oceno „čista koža“ ali „skoraj čista koža“ po lestvici ISGA).
English: The safety profile of the EE/DRSP is known from its use as oral contraception.
Slovenian: Varnostni profil kombinacije etinilestradiola in drospirenona je dobro znan iz uporabe kot peroralnega kontracepcijskega sredstva.
English: Overall, the safety profile of EE/DRSP oral contraceptives is known from its use as oral contraception and associated with rare but serious adverse events (i.e. VTE and breast cancer).
Slovenian: Na splošno je varnostni profil peroralnih kontracepcijskih sredstev z etinilestradiolom in drospirenonom znan iz njihove uporabe v kontracepcijske namene ter je povezan z redkimi, vendar resnimi neželenimi učinki (in sicer venskimi trombemboličnimi dogodki in rakom dojke).
English: With regard to breast cancer risk, the largest meta-analysis to date, including 53297 women with breast cancer and 100239 controls, showed that current use of combined OCs was associated with a relative risk (RR) of 1.24 (95 % confidence interval 1.15-1.33).
Slovenian: V zvezi s tveganjem za raka dojke je največja metaanaliza do zdaj, ki je zajela 53 297 žensk z rakom dojke in 100 239 kontrolnih oseb, pokazala, da je trenutna uporaba kombiniranih peroralnih kontracepcijskih sredstev povezana z relativnim tveganjem (RT) 1,24 (95-odstotni interval zaupanja 1,15-1,33).