FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies as well as clinical efficacy data show that the lincomycin-spectinomycin combination is active against Lawsonia intracellularis.
Maltese: Studji in vitro kif ukoll tagħrif dwar effikaċja klinika juru li l-kombinazzjoni linkomiċinaspektinomiċina hija attiva kontra Lawsonia intracellularis.
English: Evaluation of the benefit-risk balance
Maltese: 3. Valutazzjoni Benefiċċji/Riskji
English: MANUFACTURER'S BATCH NUMBER Lot:
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the product Linco-Spectin 100 (and associated names).
Maltese: Din il-valutazzjoni benefiċċji/riskji ssir fil-kuntest tal-Artikolu 34 tad-Direttiva 2001/82/KE, li filproċedura preżenti għandha l-għan li tikseb armonizzazzjoni fi ħdan l-UE tal-kundizzjonijiet ta' awtorizzazzjoni għall-prodott Linco-Spectin 100 (u ismijiet assoċjati).
English: Powder for Oral Solution
Maltese: Trab għal soluzzjoni orali
English: However, the most prevalent mechanism in B. hyodysenteriae and mycoplasmas is the alteration of the binding site through mutational events (chromosomal resistance).
Maltese: Madanakollu, l-aktar mekkaniżmu prevalenti f'B.hyodysenteriae u mikoplażmi huwa l-alterazzjoni tas-sit tal-irbit permezz ta' każijiet mutazzjonali (reżistenza kromożomali).
English: Lincomycin resistance is widespread in B. hyodysenteriae and may lead to clinical treatment failure.
Maltese: Ir-reżistenza għal linkomiċina hu mifrux f‘B. hyodysenteriae u jista‘ jwassal għal falliment fit trattament kliniku.
English: Overall, considering also older literature data, the relatively narrow MIC ranges and low MIC50 and MIC90 values, together with a monomodal distribution are indicative of a low resistance level which seems not to be evolving.
Maltese: B'mod ġenerali, u wara li tiġi kkunsidrata wkoll id-dejta minn tagħrif eqdem, il-meded tal-MIC relattivament ristretti u l-valuri baxxi tal-MIC50 u l-MIC90, flimkien ma' distribuzzjoni monomodali jindikaw livell ta' reżistenza baxxa li donnha mhijiex tevolvi.
English: Avda.
Maltese: OĦRA
English: Powder
Maltese: Tiġieġ
English: However, the CVMP considered the indication for B. hyodysenteriae should be maintained, taking into account the scope of this Article 34 referral procedure.
Maltese: Madankollu, is-CVMP ikkunsidra li l-indikazzjoni għal B. hyodysenteriae għandha tinżamm, filwaqt li jitqies il-kamp ta' applikazzjoni ta' din il-proċedura ta' riferiment tal-Artikolu 34.
English: * All modern authors appear to agree that there is widespread resistance of B. hyodysenteriae to lincomycin, although there is no clinical breakpoint available and it is not known to which extent strains with increased MICs are clinically resistant;
Maltese: • L-awturi moderni kollha jidhru li jaqblu li hemm reżistenza komuni ta' B. hyodysenteriae għal lincomycin, għalkemm m'hemm l-ebda breakpoint kliniku disponibbli u mhuwiex magħruf sa liema punt razez b'żieda fl-MICs huma klinikament reżistenti;
English: People with known hypersensitivity to lincomycin, spectinomycin or soybean millfeed should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għal linkomiċina, spektinomiċina jew maġimfiċju tas-sojja għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: Personal protective equipment consisting of approved dust masks (either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN 140 with a filter EN 143), gloves and safety glasses should be worn when handling and mixing the product.
Maltese: Tagħmir ta' protezzjoni personali li jikkonsisti minn maskri approvati għal trab (jew respiratur ta' nofs maskra li wara li jintuża jintrema li jikkonforma mal-Istandard Ewropew EN149 jew respiratur li ma jintremiex wara li jintuża li jikkonforma ma' EN 140 b'filter ta' EN 143) ingwanti u nuċċalijiet tassigurtà għandhom jintlibsu meta timmanipula u tħallat il-prodott.
English: Pigs Chickens
Maltese: Qżieqes Tiġieġ
English: Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: MA (EU) number (Invented) name
Maltese: Użu għal ġol-muskoli kunjett (ħġieġ) 10 kunjetti
English: Pack size
Maltese: Mnejn jingħata Il-pakkett
English: Critical evaluation
Maltese: Evalwazzjoni kritika
English: No additional modifications were made by the CHMP.
Maltese: Ma saret ebda modifikazzjoni addizzjonali mis-CHMP.
English: The proposed indication for Seasonique was “oral contraception”.
Maltese: L-indikazzjoni proposta għal Seasonique kienet “kontraċezzjoni orali”.
English: This study included 52,664 women (mean age, 27.3 years) in the 84/7 vs. 21/7 analysis (n=26,332 in both groups) and 50,694 (mean age, 27.8 years) in the 84/7 vs. 24/4 analysis (n=25,347 in both groups).
Maltese: Dan l-istudju inkluda 52,664 mara (età medja, 27.3 sena) fl-analiżi 84/7 vs. 21/7 (n=26,332 fiż-żewġ gruppi) u 50,694 (età medja, 27.8 sena) fl-analiż 84/7 vs. 24/4 (n=25,347 fiż-żewġ gruppi).
English: • The Committee considered the notification of the referral triggered by France under Article 29(4) of Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra n-notifikazzjoni tar-referenza attivata minn Franza skont l-Artikolu 29(4) tadDirettiva 2001/83/KE.
English: Study PSE-302 included a limited number of cycles of exposure and was not designed for PI evaluation.
Maltese: Studju PSE-302 inkluda numru limitat ta' ċikli ta' espożizzjoni u ma kienx iddisinnjat għal evalwazzjoni tal-PI.
English: Similar number of patients reported unscheduled bleeding of each severity: 64 (80.0%) and 69 (78.4%) for light bleeding, 42 (52.5%) and 42 (47.7%) for moderate bleeding and 14 (17.5%) and 13 (14.8%) for heavy bleeding, for Seasonique and for the comparator groups, respectively.
Maltese: Numru simili ta' pazjenti irrappurtaw fsada mhux skedata ta' kull severità: 64 (80.0%) u 69 (78.4%) għal fsada ħafif, 42 (52.5%) u 42 (47.7%) għal fsada moderata u 14 (17.5%) u 13 (14.8%) għal fsada qawwija, għal Seasonique u għall-gruppi komparaturi, rispettivament.
English: Comparable withdrawal rates were observed in Study PSE-302 for the Seasonique group (51.6%) and for the comparator group (49.5%).
Maltese: Rati ta' irtirar komparabbli dehru fl-Istudju PSE-302 għall-grupp ta' Seasonique (51.6%) u għall-grupp tal-kumparatur (49.5%).
English: The bleeding pattern of Seasonique was compared to the standard 21/7-day cycle regimen (Nordette, LGN 150 µg/ EE 30 µg and 7-day HFI) in the study PSE 302.
Maltese: Ix-xejra tal-fsada ta' Seasonique tqabblet mal-kors ta' ċiklu 21/7-ijiem standard (Nordette, LGN 150 µg/ EE 30 µg u 7-ijiem HFI) fl-istudju PSE 302.
English: Grounds for positive opinion
Maltese: Raġunijiet għal opinjoni pożittiva
English: A referral was thus triggered at the CMDh.
Maltese: Għalhekk ingħata bidu għal referenza mis-CMDh.
English: Seasonique is a 91-day extended regimen oral contraceptive consisting of a fixed dose combination of levonorgestrel 150 µg/ ethinylestradiol 30 µg for 84 days followed by ethinylestradiol 10 µg film-coated tablets for 7 days.
Maltese: Seasonique huwa kontraċettiv orali b'kors estiż fuq 91 ġurnata li jikkonsisti minn kombinazzjoni ta' doża fissa ta' levonorgestrel 150 µg/ ethinylestradiol 30 µg għal 84 ġurnata segwit minn pilloli miksijin b'rita ta' 10 µg ethinylestradiol għal 7 ijiem.
English: With this method, chosen post-hoc, adequate precision with regard to requirements for hormonal contraceptive methods in the CHMP Guideline on Clinical Investigation of steroid contraceptives in women (EMEA/CPMP/EWP/519/98 Rev. 1) would just be reached (depending on the specific bootstrap simulation) with a point estimate of 0.76 and a 95 % CI of (0.0 - 1.76).
Maltese: B'dan il-metodu, magħżul post-hoc, preċiżjoni xierqa fir-rigward tar-rekwiżiti għal metodi ta' kontraċezzjoni ormonali fil-Linji Gwida tas-CHMP fuq Investigazzjoni Klinika ta' kontraċettivi bl-isterojdi (EMEA/CPMP/EWP/519/98 Rev. 1) tintlaħaq bl-eżatt (jiddependi fuq is-simulazzjoni bootstrap speċifika) bi stima tal-punt ta' 0.76 u 95 % CI ta' (0.0 - 1.76).
English: One-year pregnancy rates were statistically significantly lower with the 84/7 regimen compared with the 21/7 (4.4% vs. 7.3%; p<0.0001) and with the 24/4 (4.4% vs. 6.9%, p<0.0001) regimens.
Maltese: 7.3%; p<0.0001) u mal-24/4 (4.4% vs. 6.9%, p<0.0001).
English: This more pronounced suppression was also demonstrated with 24/4 drospirenone 3 mg/EE 2 µg regimen compared to a standard 21/7 regimen (Klipping, 2008), for the 24/4 oral regimen with a nomegestrol acetate/17b-estradiol compared to the 21/7 regimen (ChristinMaitre, 2011), and for a 23-day regimen of 0.075 mg gestodene/20 µg EE compared with a 21-day regimen (Spona, 1996).
Maltese: Dan it-trażżin aktar evidenti ntwera wkoll b'kors ta' 24/4 drospirenone 3 mg/EE 2 µg meta mqabbel ma' kors ta' 21/7 standard (Klipping, 2008), għall-kors orali ta' 24/4 b'nomegestrol acetate/17b-estradiol meta mqabbel ma' kors ta' 21/7 (Christin-Maitre, 2011), u għal kors ta' 23 jum ta' 0.075 mg gestodene/20 µg EE meta mqabbel ma' kors ta' 21 jum (Spona, 1996).
English: The decentralised marketing authorisation application was submitted under Article 28(3) of Directive 2001/83/EC in accordance with Article 10b of Directive 2001/83/EC.
Maltese: L-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq deċentralizzata ġiet sottomessa skont lArtikolu 28(3) tad-Direttiva 2001/83/KE skont l-Artikolu 10b tad-Direttiva 2001/83/KE.
English: Bleeding pattern
Maltese: Xejra tal-fsada
English: The CHMP requested advice from the Biostatistics Working Party (BSWP) on the validity of this method in the present case.
Maltese: Is-CHMP talab parir mill-Grupp ta' Ħidma Biostatistika (BSWP - Biostatistics Working Party) dwar il-validità ta' dan il-metodu fil-każ preżenti.
English: Levels of folliclestimulating hormone (FSH), luteinizing hormone (LH), estradiol, and inhibin B were suppressed more effectively when the duration of the HFI was shortened from 7 days to 3 or 4 days per 28-day treatment cycle (Willis, 2006).
Maltese: Il-livelli tal-ormon li jistimula l-follikuli (FSH - folliclestimulating hormone), l-ormon luteinizzatur (LH - luteinizing hormone), estradiol, u inhibin B ġew imrażżna b'mod iktar effettiv meta t-tul tal-HFI tqassar minn 7 ijiem għal 3 jew 4 ijiem kull ċiklu ta' kura ta' 28 jum (Willis, 2006).
English: Indeed, as in the pivotal study PSE-301 the classic Poisson method failed to reach adequate precision for the 95% CI of the overall Pearl Index (PI) point estimate for Seasonique in women aged 18-35 years (point estimate 0.76, 95% CI of 0.16 - 2.22), the Applicant presented additional analyses using a bootstrap method for calculation of the 95% CI.
Maltese: PSE-301, il-metodu klassiku Poisson naqas milli jilħaq preċiżjoni xierqa għal CI 95 % tal-istima tal-punt tal-Indiċi Pearl (PI) globali għal Seasonique f'nisa ta' bejn 18 u 35 sena (stima talpunt ta' 0.76, CI 95 % ta' 0.16 - 2.22), l-Applikant ippreżenta analiżijiet addizzjonali bl-użu ta' metodu bootstrap għall-kalkolu ta' CI 95 %.
English: PD data showed that the ovarian inhibiting efficacy of Seasonique is within the range of that observed for other approved combined hormonal contraceptives.
Maltese: Dejta FD uriet li l-effikaċja tal-inibizzjoni ovarjana ta' Seasonique qiegħda fil-firxa osservata għal kontraċettivi ormonali kkombinati.
English: Contraceptive efficacy
Maltese: Effikaċja tal-kontraċezzjoni
English: Levonorgestrel (LGN) is a progestogen known to inhibit ovulation, whilst the low dose ethinylestradiol (EE), an estrogen, ensures control over ovarian follicular suppression and provides stability to the endometrium in order to minimise breakthrough bleeding.
Maltese: Levonorgestrel (LGN) huwa progestogen magħruf li jinibixxi ovulazzjoni, filwaqt li ethinylestradiol (EE), estroġenu, ta' doża baxxa jiżgura kontroll fuq ittrażżin ovarjan follikolari u jagħti stabbilità lill-endometriju sabiex inaqqas fsada ‘breakthrough' kemm jista' jkun.
English: A published study with 3 different combined oral contraceptives (COCs) arms, reported that women treated with a continuous 28-day regimen had more pronounced follicular suppression than women who were either supplemented with 5 days of 10 µg EE or had a 7-day HFI (Schlaff, 2004).
Maltese: Studju ppubblikat bi 3 fergħat ta' kontraċettivi orali kombinati (KOKs) differenti, irrapporta li nisa kkurati b'kors kontinwu ta' 28 jum kellhom soppressjoni follikulari aktar evidenti minn nisa li jew kienu ssupplimentati b'5 ijiem ta' 10 µg EE jew kellhom HFI ta' 7 ijiem (Schlaff, 2004).
English: Based on the results from these published clinical studies Seasonique is expected to have a greater control over ovulation, leading in turn to a higher contraceptive efficacy compared to standard 21/7day LNG/EE COCs and therefore a comparative pharmacodynamic study against standard 21/7-day LNG/EE COCs is not considered mandatory.
Maltese: Abbażi tar-riżultati minn dawn l-istudji kliniċi ppubblikati, Seasonique mistenni jkollu kontroll ikbar fuq l-ovulazzjoni, u dan iwassal għal effikaċja akbar fil-kontraċezzjoni meta mqabbel ma' KOKs 21/7-ijiem LNG/EE standard u għalhekk studju farmakodinamiku komparattiv kontra KOKs 21/7-ijiem LNG/EE standard mhuwiex ikkunsidrat obbligatorju.
English: A risk management plan was submitted and agreed upon during the preceding Decentralised Procedure on Seasonique.
Maltese: Pjan ta' ġestjoni tar-riskji ġie sottomess u sar qbil fuqu waqt il-Proċedura Deċentralizzata preċedenti dwar Seasonique.
English: From data outside the EU, since the first authorisation in 2006 until December 2013, while the estimated exposure is 385,901 women-years, only 10 pregnancies were reported resulting in a pregnancy reporting rate of 0.0026 %.
Maltese: Minn dejta barra mill-UE, mill-ewwel awtorizzazzjoni fl-2006 sa Diċembru 2013, filwaqt li lespożizzjoni stmata hija 385,901 mara kull sena, 10 tqaliet biss ġew rappurtati li jirriżultaw f'rata ta' tqaliet rappurtati ta' 0.0026 %.
English: In the pivotal study PSE-301, 3 pregnancies were observed for Seasonique in 1,578 91-day cycles in 621 women aged 18-35 years, resulting in an overall PI of 0.76 with a 95% CI of 0.16 - 2.22 using the Poisson model.
Maltese: PSE-301, 3 tqaliet ġew osservati għal Seasonique f'ċikli ta' 1,578 ċiklu ta' 91 jum f'612-il mara li kellhom bejn 18 u 35 sena, li rriżultaw f'PI globali ta' 0.76 b'CI 95 % ta' 0.16 - 2.22 blużu tal-mudell Poisson.
English: The clinical development program for Seasonique included two phase III randomised clinical trials, the pivotal study PSE-301 and a supportive study, PSE-302, specifically designed to assess endometrial biopsy results, which were performed in the United States.
Maltese: PSE-301 u studju ta' appoġġ, PSE-302, speċifikament iddisinnjat biex jevalwa riżultati ta' bijopsiji endometrijali, li twettqu fl-Istati Uniti.
English: Moreover the applicant conducted a non-comparative pharmacodynamic (PD) study DR-105-101 during one extended cycle of 91 days (84 days of LNG/EE, followed by 7 days of EE only).
Maltese: Barra minn hekk, l-applikant wettaq studju farmakodinamiku (FD) DR-105-101 waqt ċiklu estiż ta' 91 jum (84 jum ta' LNG/EE, segwit minn 7 ijiem ta' EE biss).
English: This was further supported by the absence of anaemia or clinically important changes in the laboratory results compared to the 21/7-day COC.
Maltese: Dan ġie appoġġjat aktar bin-nuqqas ta' anemija jew bidliet klinikament importanti fir-riżultati tal-laboratorju meta mqabbel mal-KOK 21/7-ijiem.
English: Indeed the LNG 150 µg/ EE 30 µg hormonal combination has been approved as a contraceptive in the EU for over 35 years and its efficacy is well documented.
Maltese: Tabilħaqq, il-kombinazzjoni ormonali LNG 150 µg/ EE 30 µg ilha approvata bħala kontraċettiv fl-UE għal aktar minn 35 sena u l-effikaċja tagħha hija ddokumentata sew.
English: Due to the low estrogen content, the preparation belongs to the so-called low-dose combined oral contraceptives (COCs).
Maltese: Minħabba l-kontenut baxx ta' estroġenu, il-preparazzjoni tappartjeni għall-hekk imsejħa kontraċettivi orali kkombinati b'doża baxxa (COCs - combined oral contraceptives).
English: Another published pharmacodynamic study reported a continuous COC regimen with Levonorgestrel/EE and norgestimate/EE to result in a more effective follicular suppression than the same COC dosing regimen with a monthly 7-day HFI (Birtch, 2006).
Maltese: Studju farmakodinamiku ieħor ippubblikat irrapporta li kors kontinwu ta' KOK b'Levonorgestrel/EE u norgestimate/EE jirriżulta fi trażżin follikolari iktar effettiv mill-istess kors ta' dożaġġ ta' KOK b'HFI ta' 7
English: Both active substances are already authorised in this combination, at this dosage and at a lower dosage (LGN 100 µg/ EE 20 µg).
Maltese: Iż-żewġ sustanzi attivi huma diġà awtorizzati f'din il-kombinazzjoni, b'dan id-dożaġġ u b'dożaġġ aktar baxx (LGN 100 µg/ EE 20 µg).
English: Statistically significantly higher rates of pregnancy with 21/7 and 24/4 regimens compared to the 84/7 regimen (p<0.0001) were also seen in the 2- and 3-year cohorts (Howard, 2014).
Maltese: Rati ta' tqala ferm għola bil-korsijiet 21/7 u 24/4 meta mqabbel mal-kors 84/7 (p<0.0001) dehru wkoll fil-gruppi ta' sentejn jew 3 (Howard, 2014).
English: Moreover the pregnancy rate observed in the phase III clinical trial was relatively low (PI<1), and no signal of a reduced efficacy was detected in the large experience obtained post-marketing.
Maltese: III kienet relattivament baxxa (PI<1), u ma deher ebda sinjal ta' effikaċja imnaqqsa flesperjenza kbira miksuba wara t-tqegħid fis-suq.
English: The total number of days with bleeding/spotting within the planned study duration of 1 year was higher for the Seasonique group than for the comparator group (mean 61-62 vs. 55-56 depending on the extrapolation rule).
Maltese: In-numru totali ta' ġranet bi fsada fiż-żmien ippjanat tal-istudju ta' sena kien ogħla għall-grupp ta' Seasonique milli għall-grupp tal-komparatur (medja ta' 61-62 vs. 55-56 skont ir-regola talestrapolazzjoni).
English: As mentioned, the applicant presented during the DCP additional analysis with the bootstrap method reaching adequate precision for contraceptive methods as shown by the 95 % CI: 0.0 - 1.76, however concerns were raised regarding the coverage probability properties of this posthoc analysis.
Maltese: Kif imsemmi, l-applikant ippreżenta analiżi addizzjonali waqt id-DCP bil-metodu bootstrap jilħaq preċiżoni xierqa għall-metodi kontraċettivi kif muri bis-CI 95 %: 0.0 - 1.76, madankollu tqajjem tħassib fir-rigward tal-karatteristiċi tal-kopertura tal-probabiltà ta' din l-analiżi post-hoc.
English: In addition, a 1-year retrospective study in women 15 to 40 years of age, showed that reported pregnancy rates were lower with extended regimen OC (84/7) than with ‘standard' regimens (21/7 and 24/4).
Maltese: Barra minn hekk, studju retrospettiv ta' sena f'nisa ta' bejn 15 u 40 sena, wera li r-rati ta' tqala rrapportati kienu aktar baxxi b'kors estiż KO (84/7) milli b'kors ‘standard' (21/7 u 24/4).
English: Thus the absence of HFI is not considered to decrease the contraceptive efficacy and the CHMP considered that the well- documented contraceptive efficacy with 28-day LGN 150 µg/ EE 30 µg combination can be extrapolated to the Seasonique regimen.
Maltese: Għalhekk in-nuqqas ta' HFI mhijiex ikkunsidrata li tnaqqas l-effikaċja tal-kontraċezzjoni u s-CHMP ikkunsidra li l-effikaċja tal-kontraċezzjoni ddokumentata sew b'kombinazzjoni LGN 150 µg/ EE 30 µg għal 28 jum tista' tiġi estrapolata għall-kors ta' Seasonique.
English: In spite of these limitations, this publication at least does not support a reduced contraceptive efficacy associated with the 84/7 regimen.
Maltese: Minkejja dawn il-limitazzjonijiet, il-pubblikazzjoni ma tappoġġjax effikaċja ta' kontraċezzjoni mnaqqsa assoċjata mal-kors ta' 84/7.
English: Overall benefit-risk balance
Maltese: Bilanċ ġenerali tal-benefiċċju-riskju
English: The overall treatment compliance for all treated patients was ≥ 97% in the pivotal study and ≥ 98% in the supportive study.
Maltese: Il-konformità mal-kura totali għall-pazjenti kkurati kollha kienet ≥ 97% fl-istudju pivotali u ≥ 98% flistudju ta' appoġġ.
English: In conclusion, although the PD study did not include a comparative arm, based on extensive results from published clinical studies and considering that the extended regimen in Seasonique is a minor modification from existing products, Seasonique is expected to have a greater control over ovulation compared to the existing LNG/EE combination products for which the efficacy is well documented.
Maltese: Bħala konklużjoni, għalkemm l-istudju FD ma inkludiex fergħa komparattiva, abbażi ta' riżultati estensivi minn studji kliniċi ppubblikati u b'kunsiderazzjoni għall-fatt li l-kors estiż f'Seasonique huwa modifikazzjoni minuri minn prodotti eżistenti, Seasonique huwa mistenni li jkollu kontroll ikbar fuq lovulazzjoni meta mqabbel mal-prodotti ta' kombinazzjoni LNG/EE eżistenti li għalihom l-effikaċja hija ddokumentata sew.
English: Ovulation occurred in two subjects (5.71% of the women) during the second 28-day period, one whom also ovulated in the third period, resulting in an overall ovarian activity rate of 2.86 (95% CI: 0.78 -7.22) over a period of 91 days.
Maltese: Ovulazzjoni seħħet f'żewġ suġġetti (5.71% tan-nisa) waqt ittieni perjodu ta' 28 jum, waħda minnhom ovulat ukoll fit-tielet perjodu, u dan irriżulta f'rata ta' attività ovarjana totali ta' 2.86 (CI 95 %: 0.78 -7.
English: During the decentralised procedure, the Objecting Member State (OMS) was of the view that the contraceptive efficacy of Seasonique had not been sufficiently demonstrated.
Maltese: Waqt il-proċedura deċentralizzata, l-Istat Membru li Oġġezzjona (OMS - Objecting Member State) kien tal-fehma li l-effikaċja ta' kontraċezzjoni ta' Seasonique ma ntweritx b'mod suffiċjenti.
English: Some CHMP members considered that this publication is not acceptable as proof of contraceptive efficacy of extended cycle regimens as this type of study is prone to various kinds of confounders (duration of use of the different COCs, intention of pregnancy, use for other reasons than contraception).
Maltese: Xi membri tas-CHMP qiesu li din it-tip ta' pubblikazzjoni hija inaċċettabbli bħala prova tal-effikaċja ta' kontraċezzjoni ta' korsijiet b'ċikli estiżi minħabba li dan it-tip ta' studju huwa soġġett għal diversi tipi ta' fatturi ta' tfixkil (tul tal-użu ta' KOKs differenti, intenzjoni ta' tqala, użu għal raġunijiet oħrajn barra kontraċezzjoni).
English: Moreover, standard 21/7-day COCs containing LGN 150 µg/ EE 30 µg are widely used and, according to the respective product information in some Member States, the cycle can be extended to 2-months, without HFI.
Maltese: Barra minn hekk, COCs 21/7-jiem standard li fihom LGN 150 µg/ EE 30 µg jintużaw b'mod komuni u, skont l-informazzjoni tal-prodott rispettiva f'xi Stati Membri, iċ-ċiklu jista' jiġi estiż għal xahrejn, mingħajr HFI.
English: On the contrary, the total number of unscheduled bleeding/spotting days was twice higher for Seasonique than for the comparator (mean 53 vs. 24).
Maltese: Għall-kuntrarju, in-numru totali ta' fsada mhux skedata kien darbtejn ogħla għal Seasonique milli għall-komparatur (medja 53 vs. 24).
English: The CHMP supported the position of the BSWP, which considered that the bootstrap method is generally inappropriate for calculating confidence intervals for a PI; even more so in this example where it was not pre-specified, and was employed only after negative results were seen for the more conventional analysis.
Maltese: Is-CHMP appoġġja l-pożizzjoni tal-BSWP, li kkunsidra l-metodu bootstrap bħala li huwa wieħed ġeneralment mhux adegwat għall-kalkolu tal-intervalli ta' fiduċja għal PI; iktar u iktar f'dan l-eżempju fejn ma kienx speċifikat minn qabel, u ntuża biss wara li riżultati negattivi dehru għall-analiżi aktar konvenzjonali.