FrancophonIA/ELRC3.0 huggingface dataset:
English: Written explanations were provided by a group of marketing authorisation holders on 11 January 2012.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti minn grupp ta' detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fil11 ta'Jannar 2012.
English: Study CT07
Maltese: Studju CT07
English: Available from: http://www.ginasthma.org/.
Maltese: Disponibbli minn fuq: http://www.ginasthma.org/
English: Literature data
Maltese: Dejta letterarja
English: Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2011.
Maltese: Strateġija Globali għall-Ġestjoni u l-Prevenzjoni tal-Ażżma, Inizjattiva Globali għall-Ażżma (Global Initiative for Asthma - GINA) 2011.
English: This comparability has also been confirmed in a comparative clinical study between Kantos Master and associated names (Foster 10/6) and Symbicort 200/6 (budesonide/formoterol)3.
Maltese: Dan it-tqabbil ġie kkonfermat ukoll fi studju kliniku komparattiv bejn Kantos Master u ismijiet assoċjati (Foster 10/6) u Symbicort 200/6 (budesonide/formoterol)3.
English: Post hoc analysis of data from study CT07
Maltese: Analiżi tad-dejta post hoc mill-istudju CT07
English: Kantos Master in MART was also significantly efficacious regarding the mean number of rescue medication at entry to the study (>0 and ≤1, >1 and ≤2, and >2) in the three groups (similar hazard ratio of 0.51, 0.64 and 0.52, respectively).
Maltese: Kantos Master f'MART kien ukoll konsiderevolment effikaċi rigward in-numru medju ta' mediċina ta' salvataġġ meta daħlu għall-istudju (>0 u ≤1, >1 u ≤2, u >2) fit-tliet gruppi (proporzjon ta' periklu simili ta' 0.51, 0.64 u 0.52, rispettivament).
English: • The Committee considered the referral under article 13(2) of Regulation No 1234/2008
Maltese: • Il-Kumitat ikkunsidra r-referenza taħt l-Artikolu 13(2) tar-Regolament Nru 1234/2008
English: Kantos Master is a fixed-dose combination (FDC) of the inhaled corticosteroid (ICS) beclometasone diproprionate (BDP) and the long-acting beta2-agonist (LABA) formoterol fumarate (FF) which is indicated as regular maintenance treatment of asthma administrated twice daily.
Maltese: Kantos Master huwa taħlita f'doża fissa (FDC) tal-kortikosterojd inalat (ICS) beclometasone diproprionate (BDP) u l-agonist tal-beta2 li jaġixxi fit-tul (LABA) formoterol fumarate (FF) li huwa indikat bħala kura ta' manutenzjoni regolari tal-ażżma mogħtija darbtejn kuljum.
English: Additional supportive data
Maltese: Dejta ta' appoġġ addizzjonali
English: In both more severe (defined by FEV1 < 70%) and less severe groups (FEV1 ≥ 70%), Kantos Master in MART was significantly efficacious (similar hazard ratio of 0.65 and 0.61, respectively).
Maltese: Kemm fil-gruppi b'ażżma severa (definiti permezz ta' FEV1 < 70%) u f'dawk b'ażżma inqas severa (FEV1 ≥ 70%), Kantos Master f'MART kien konsiderevolment effikaċi (proporzjon ta' periklu simili ta' 0.65 u 0.61, rispettivament).
English: The referral procedure was initiated on 13 December 2012.
Maltese: Il-proċedura ta' referenza nbdiet fit-13 ta' Diċembru 2012.
English: For instance, in the SMILE study2, the dose of budesonide (400µg/day) was in line with the ICS dose administrated in the study CT07 (500µg BDP non-extrafine equivalent).
Maltese: Pereżempju, fl-istudju SMILE2, id-doża ta' budesonide (400µg/kuljum) kienet konformi mad-doża ta' ICS mogħtija fl-istudju CT07 (ekwivalenti għal 500µg BDP mhux fin ħafna).
English: The patients enrolled in this study were being treated with a higher mean ICS dose at entry to the study (between 700µg and 1100µg, expressed as labelled or BDP equivalent dose respectively) than during the clinical study (ICS dose in the group taking Kantos Master as reliever and in the group taking salbutamol was respectively about 701.2 µg/day and 488.8 µg/day, always given as part of an ICS-LABA combination).
Maltese: Il-pazjenti li daħlu għal dan l-istudju kienu qegħdin jingħataw kura b'doża medja ogħla ta' ICS meta bdew l-istudju (bejn 700µg u 1100µg, espressa bħala doża tikkettata jew ekwivalenti għal BDP rispettivament) milli waqt l-istudju kliniku (id-doża ta' ICS fil-grupp li kien qed jingħata Kantos Master bħala solliev u filgrupp li kien qed jingħata salbutamol kienet rispettivament madwar 701.2 µg/kuljum u 488.8 µg/kuljum, dejjem mogħtija bħala parti minn taħlita ta' ICS-LABA).
English: Inhaled beclometasone dipropionate /formoterol extra fine fixed combination in the treatment of asthma: evidence and future perspectives.
Maltese: Taħlita inalata fissa ta' beclometasone dipropionate /formoterol fina ħafna fil-kura tal-ażżma: evidenza u perspettivi futuri.
English: The daily maintenance dose, in both arms of the study was 200µg of extrafine beclometasone, which is clinically equivalent to 500µg of non extrafine beclometasone.
Maltese: Id-doża ta' manutenzjoni ta' kuljum, fiż-żewġ fergħat tal-istudju kienet ta' 200µg ta' beclometasone fin ħafna, li hija klinikament ekwivalenti għal 500µg ta' beclometasone mhux fin ħafna.
English: On 20 January 2012, the MAH submitted a type II variation via the MRP for Kantos Master and associated names (DE/H/0873/001/II/024), to request the inclusion of “Maintenance and reliever therapy taken as regular maintenance treatment and as needed in response to asthma symptoms”.
Maltese: Fl-20 ta' Jannar 2012, il-MAH issottometta varjazzjoni tat-tip II permezz tal-MRP għal Kantos Master u ismijiet assoċjati (DE/H/0873/001/II/024), sabiex jitlob l-inklużjoni ta' “Terapija ta' manutenzjoni u ta' solliev meħuda bħala kura ta' manutenzjoni regolari u skont il-ħtieġa kontra s-sintomi tal-ażżma”.
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 23 November 2012, Germany triggered a referral under Article 13 of Commission Regulation EC No 1234/2008.
Maltese: Minħabba li l-Istat Membru ta' referenza u l-Istati Membri kkonċernati ma setgħux jaqblu rigward din ilvarjazzjoni, fit-23 ta' Novembru 2012, il-Ġermanja tat bidu għal referenza taħt l-Artikolu 13 tarRegolament tal-Kummissjoni KE Nru 1234/2008.
English: The study CT07 compared the efficacy of Kantos Master and associated names given as both maintenance and reliever therapy and Kantos Master given as maintenance therapy with salbutamol (short acting beta2 -agonist SABA) as reliever therapy in partially controlled or uncontrolled asthmatics, over a 48 weeks treatment.
Maltese: L-istudju CT07 qabbel l-effikaċja ta' Kantos Master u ismijiet assoċjati mogħti kemm bħala terapija ta' manutenzjoni u ta' solliev kif ukoll Kantos Master mogħti bħala terapija ta' manutenzjoni flimkien ma' salbutamol (agonist SABA tal-beta2 li jaġixxi għal żmien qasir) bħala terapija ta' solliev f'persuni b'ażżma parzjalment ikkontrollata jew mhux ikkontrollata, fuq perjodu ta' kura ta' 48 ġimgħa.
English: These results were irrespective of the type of fixed ICS/LABA comparator (budesonide/formoterol or salmeterol/fluticasone), and irrespective of whether the maintenance dose of the comparator was similar or up to two fold higher.
Maltese: Dawn ir-riżultati kienu irrispettivament mit-tip ta' komparatur ICS/LABA fiss (budesonide/formoterol jew salmeterol/fluticasone), u irrispettivament minn jekk id-doża ta' manutenzjoni tal-komparatur kinitx simili jew sa darbtejn ogħla.
English: • The Committee noted that there was no comparison with the standard of care, according to the GINA guideline.
Maltese: • Il-Kumitat innota li ma kien hemm l-ebda tqabbil mal-istandard ta' kura, skont il-linja gwida GINA.
English: A further additional analysis of the study CT07 has been conducted in patients with severe asthma as it was considered that if under-treatment with Kantos Master in MART occurred, it should be most evident in this population who requires higher ICS doses to control their asthma.
Maltese: Din l-analiżi addizzjonali wriet ukoll li Kantos Master f'MART mhuwiex assoċjat ma' nuqqas ta' kura ta' pazjenti f'każ ta' ażżma mhux ikkontrollata.
English: Overall summary of the scientific evaluation of Kantos Master and associated names (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Kantos Master u ismijiet assoċjati (ara l-Anness I)
English: Further evidence in the literature has suggested that dose reduction from high to moderate maintenance ICS does not affect outcomes of MART treatment.
Maltese: Evidenza oħra fil-letteratura indikat li t-tnaqqis tad-doża ta' manutenzjoni ta' ICS minn għolja għal moderata ma taffettwax l-eżiti tal-kura MART.
English: Significant improvements were also observed in the secondary efficacy variables (Forced Expiratory Volume in the 1st second (FEV1), asthma symptoms, medication free days etc.) in both treatment arms.
Maltese: titjib sinifikanti fil-varjabbli sekondarji tal-effikaċja (Volum tan-Nifs Sfurzat fl-ewwel sekonda (FEV1), sintomi tal-ażżma, ġranet fejn ma tittiħedx mediċina eċċ.) fiż-żewġ fergħat ta' kura.
English: Moreover, the onset of action of formoterol as a bronchodilator is faster compared to other LABAs such as salmeterol, and is therefore well suited for the acute relief of bronchospasm.
Maltese: Barra minn hekk, il-bidu tal-azzjoni ta' formoterol bħala dilatur tal-bronki huwa aktar mgħaġġel meta mqabbel ma' LABAs oħrajn bħal salmeterol, u għalhekk huwa adattat ħafna għas-solliev akut ta' spażmi tal-bronki.
English: This suggested that the ICS-LABA maintenance therapy was adequate to control both lung function and symptoms.
Maltese: Dan kien jindika li tterapija ta' manutenzjoni b'ICS-LABA kienet adegwata biex tikkontrolla kemm il-funzjoni tal-pulmuni kif ukoll is-sintomi.
English: One arm of patients were treated with an entry ICS dose of 500 µg or less and another arm had an entry ICS dose of more than 500 µg.
Maltese: Fergħa ta' pazjenti ġiet ikkurata b'doża inizjali ta' ICS ta' 500 µg jew inqas u fergħa oħra ngħatat doża inizjali ta' ICS ta' aktar minn 500 µg.
English: • The Committee took note of literature data where the principle of MART is substantiated with the use of an ICS and LABA.
Maltese: • Il-Kumitat ħa nota tad-dejta letterarja fejn il-prinċipju ta' MART huwa ssostanzjat bl-użu ta' ICS u LABA.
English: The CHMP considered that the data provided by the MAH are sufficient to support the use of Kantos Master and associated names in the maintenance and reliever therapy (MART) taken as regular maintenance treatment and as needed in response to asthma symptom.
Maltese: Is-CHMP ikkunsidra li d-dejta pprovduta mill-MAH hija suffiċjenti sabiex issostni l-użu ta' Kantos Master u ismijiet assoċjati fit-terapija ta' manutenzjoni u ta' solliev (MART) meħud bħala kura ta' manutenzjoni regolari u skont il-ħtieġa kontra s-sintomi tal-ażżma.
English: The CHMP was therefore of the opinion that the effectiveness of Kantos Master in MART was not due to a potential under-treatment of the comparator arm in the study CT07, and that the maintenance administration of Kantos Master at one inhalation twice daily had a clinically significant benefit in these patients.
Maltese: Għaldaqstant is-CHMP kien tal-opinjoni li l-effikaċja ta' Kantos Master f'MART ma kinitx dovuta għallpossibbiltà ta' nuqqas ta' kura tal-fergħa mqabbla fl-istudju CT07, u li l-għoti ta' manutenzjoni ta' Kantos Master f'inalazzjoni waħda darbtejn kuljum kellu benefiċċju kliniku sinifikanti f'dawn il-pazjenti.
English: The similar particle size of the two components also leads to co-deposition in the same regions of the lung, favouring a synergistic interaction.
Maltese: Id-daqs simili tal-partiċelli taż-żewġ komponenti jwassal ukoll għall-kodepożizzjoni fl-istess reġjuni tal-pulmun, li tiffavorixxi interazzjoni sinerġistika.
English: Package size l t o r
Maltese: Daqs talpakkett t x
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Ottubru 2015
English: 20 October 2015 EMA/499012/2015
Maltese: EMA/499012/2015
English: Caraway oil EMA/499012/2015
Maltese: Żejt tal-karwija EMA/499012/2015
English: Caraway oil medicines must not be used in people who are hypersensitive (allergic) to caraway oil or other plants of the same Apiaceae (Umbelliferae) family (e.g. fennel, anise, celery, coriander and dill).
Maltese: Mediċini li fihom iż-żejt tal-karwija ma għandhomx jintużaw fuq persuni li għandhom sensittività eċċessiva (allerġiċi) għaż-żejt tal-karwija jew għal pjanti oħra tal-istess familja ta' Apiaceae (Umbelliferae) (eż. busbies, ħlewwa, karfus, kosbor u xibt).
English: Other information about caraway oil medicines
Maltese: Aktar informazzjoni dwar il-mediċini taż-żejt tal-karwija
English: While the skin preparations can be used by people of all ages, the medicines to be taken by mouth are not recommended in children and adolescent (under 18 years of age).
Maltese: Filwaqt li l-preparazzjonijiet tal-ġilda jistgħu jintużaw minn persuni ta' kull età, il-mediċini li għandhom jittieħdu mill-ħalq mhumiex rakkomandati fit-tfal u fl-adolexxenti (taħt it-18-il sena).
English: What is caraway oil?
Maltese: X'inhu żejt tal-karwija?
English: Caraway oil
Maltese: Żejt tal-karwija
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawsibbli u hemm evidenza li ilhom jintużaw b'dan il-mod sigur għal mill-inqas 30 sena (inkluż millinqas 15-il sena fl-UE).
English: What are the HMPC conclusions on its medicinal uses?
Maltese: X'inhuma l-konklużjonijiet tal-HMPC dwar l-użi mediċinali tiegħu?
English: Herbal medicines containing caraway oil preparations are usually available in liquid forms to be taken by mouth and in semi-solid forms (such as ointments) to be applied to the skin.
Maltese: Normalment mediċini erbali li fihom preparazzjonijiet taż-żejt tal-karwija huma disponibbli f'forom likwidi biex jittieħdu mill-ħalq u f'għamla semi-solida (bħal ingwenti) li għandhom jiġu applikati lillġilda.
English: Further information on the HMPC assessment of caraway oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini taż-żejt tal-karwija, inklużi d-dettalji talkonklużjonijiet tal-Kumitat, tinsab taħt it-tab "Id-dokumenti kollha" fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use Għal aktar informazzjoni rigward il-kura bil-mediċini tal-mediċini taż-żejt tal-karwija, aqra l-fuljett ta' tagħrif li jakkumpanja l-mediċina jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: How are caraway oil medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini taż-żejt tal-karwija?
English: For further information, see the HMPC assessment report.
Maltese: Għal iktar informazzjoni, ara r-rapport ta' valutazzjoni tal-HMPC.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway oil.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali taż-żejt tal-karwija.
English: Further information on the risks associated with caraway oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini taż-żejt tal-karwija, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: The HMPC noted the insufficient clinical data on the effects of caraway oil in patients, but took into account the well documented use of this herbal medicine for the above-mentioned use.
Maltese: L-HMPC innota d-dejta klinika insuffiċjenti dwar l-effetti taż-żejt tal-karwija fuq il-pazjenti, iżda qies lużu ddokumentat sew ta' din il-mediċina erbali għall-użu msemmi hawn fuq.
English: Any applications for the licensing of medicines containing caraway oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom iż-żejt tal-karwija għandha titressaq lillawtoritajiet nazzjonali responsabbli mill-prodotti mediċinali li ser jivvalutaw l-applikazzjoni għallmediċina erbali u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing caraway oil.
Maltese: Il-konklużjonijiet tal-HMPC jiġu kkunsidrati mill-Istati Membri tal-UE waqt il-valutazzjoni tal-applikazzjonijiet għal-liċenzjar ta' mediċini erbali li fihom iż-żejt tal-karwija.
English: The HMPC conclusions on the use of caraway oil medicines in the relief of digestive problems such as bloating and flatulence are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini li fihom iż-żejt tal-karwija għas-serħan minn problemi diġestivi bħal nefħa u gass huma bbażati fuq l-'użu tradizzjonali' tagħhom.
English: Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 pages
Maltese: Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 paġni
English: 4 Edelman, A,B., Cherala, G., Blue, S.W., Erikson, D.W., Jensen, J.T., (2016) Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing.
Maltese: 4 Edelman, A,B., Cherala, G., Blue, S.W., Erikson, D.W., Jensen, J.T., (2016) Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing. Contraception, in press.
English: The Concerned Member States (CMS) were: Austria, Belgium, Czech Republic, Germany, Greece, Spain, France, Ireland, Iceland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal and Sweden.
Maltese: L-Istati Membri Kkonċernati (CMS) kienu: l-Awstrija, il-Belġju, ir-Repubblika Ċeka, il-Ġermanja, il-Greċja, Spanja, Franza, l-Irlanda, l-Iżlanda, l-Italja, il-Litwanja, il-Lussemburgu, in-Netherlands, in-Norveġja, il-Polonja, il-Portugall u l-Iżvezja.
English: The CMDh 60 day procedure was initiated on 3 August 2015.
Maltese: Il-proċedura ta' 60 jum tas-CMDh inbdiet fit-3 ta' Awwissu 2015.
English: Also, decreases in exposure of the LNG component of combined hormonal contraceptives have been noted with several enzyme inducers: LNG AUC was reduced by 36 to 47% reductions with oxcarbazepine; 40 to 46% with carbamazepine; 42% with phenytoin; 37% with eslicarbazepine; and 40% with perampanel.
Maltese: Barra minn hekk, ġie osservat tnaqqis fl-esponiment tal-komponent tal-LNG tal-kontraċettivi ormonali kombinati b'diversi indutturi tal-enzimi: LNG AUC tnaqqas bi tnaqqis ta' 36 % għal 47 % b'oxcarbazepine; 40 għal 46 % b'carbamazepine; 42 % b'phenytoin; 37 % b'eslicarbazepine; u 40 % b'perampanel.
English: There were 75 pregnancies in the 400mcg LNG treated group, yielding a failure rate of 3.52% and a method failure rate of 1.69%.
Maltese: Kien hemm 75 tqala fil-grupp ikkurat bl-LNG ta' 400 mcg, li jirriżultaw f'rata ta' falliment ta' 3.52 % u rata ta' falliment tal-metodu ta' 1.69 %.
English: On 17 September 2014, Gedeon Richter Plc submitted an application for Levonelle and associated names through a mutual recognition procedure (MRP) type II variation (UK/H/0803/001/II/022) with the United Kingdom acting as a Reference Member State (RMS).
Maltese: Fis-17 ta' Settembru 2014, Gedeon Richter Plc ippreżentat applikazzjoni għal Levonelle u ismijiet assoċjati permezz ta' varjazzjoni tat-tip II tal-proċedura ta' rikonoxximent reċiproku (MRP) (UK/H/0803/001/II/022) bir-Renju Unit jaġixxi bħala Stat Membru ta' Referenza (RMS).
English: Johansson E, Brache V, Alvarez F, Faundes A, Cochon L, Ranta S, Lovern M, Kumar N. (2002) Pharmacokinetic study of different dosing regimens of levonorgestrel for emergency contraception in healthy women.
Maltese: Johansson E, Brache V, Alvarez F, Faundes A, Cochon L, Ranta S, Lovern M, Kumar N.
English: Day 60 of the CMDh procedure was on 1 October 2015, when a final position was reached by most MSs except Italy (IT).
Maltese: Il-Jum 60 talproċedura tas-CMDh kien fl-1 ta' Ottubru 2015, meta ntlaħqet pożizzjoni finali minn ħafna mill-Istati Membri ħlief l-Italja (IT).
English: (ii) Clinical significance of reduced plasma LNG levels
Maltese: (ii) Sinifikat kliniku ta' tnaqqis fil-livelli tal-LNG fil-plażma
English: Reduction in plasma levels with efavirenz and other enzyme inducers
Maltese: (i) It-tnaqqis fil-livelli tal-plażma b'efavirenz u indutturi ta' enzimi oħra
English: (iii) Management options - Dose increase / alternative treatment
Maltese: (iii) Għażliet ta' mmaniġġjar - Żieda fid-doża / kura alternattiva
English: Exposure to 400mcg LNG represented the largest group, with 2801 patients studied, 71% for >6 months and 48% for > 12 months.
Maltese: L-esponiment għalLNG ta' 400 mcg irrappreżenta l-ikbar grupp, b'2801 pazjent studjati, 71 % għal >6 xhur u 48 % għal >12-il xahar.
English: However this may not be realistic in all situations.
Maltese: Madankollu dan jista' ma jkunx realistiku fis-sitwazzjonijiet kollha.
English: inducers.
Maltese: Anness II
English: 1 Carten ML, Kiser JJ, Kwara A, Mawhinney S, Cu-Uvin S. (2012) Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz.
Maltese: (2012) Pharmacokinetic Interactions between the Hormonal Emergency Contraception, Levonorgestrel (Plan B), and Efavirenz.
English: However studies following after 14 days treatment with St John's wort found similar >50% decreases in AUC for midazolam or alprazolam used as probes for CYP 3A4 activity.
Maltese: Madankollu studji li jsegwu wara 14-il jum ta' kura b'St.John's wort sabu tnaqqis simili ta' >50 % fl-AUC għal midazolam jew alprazolam użati bħala sondi għall-attività ta' CYP 3A4.
English: Interestingly, a recent publication of a small PK study4 in obese women vs normal BMI women found that Cmax and AUC(0-2.5h) of total LNG was doubled when a double dose of LNG EHC (3000mcg LNG) was used.
Maltese: B'mod interessanti, pubblikazzjoni riċenti ta' studju żgħir tal-PK4 dwar nisa obeżi kontra nisa b'BMI normali sab li Cmax u AUC(0-2.5h) tal-LNG totali rdoppja meta ntużat doża doppja ta' LNG EHC (3000 mcg ta' LNG).
English: The CHMP acknowledged the limited clinical data regarding lack of efficacy of LNG-containing contraceptives with concomitant use of CYP 3A4 enzyme inducers by which to judge the clinical significance of reduced plasma LNG levels during EHC.
Maltese: Is-CHMP għaraf id-data klinika limitata rigward in-nuqqas ta' effikaċja ta' kontraċettivi li fihom LNG b'użu konkomittanti tal-indutturi tal-enzima CYP 3A4 li permezz tagħhom jista' jiġi ġġudikat is-sinifikat kliniku tal-livelli mnaqqsa tal-LNG fil-plażma waqt l-EHC.
English: One small study (n=58 women using cross-over design) found comparable efficacy of 750 and 1500mcg LNG using disruption of ovulation as an endpoint3 when LNG was taken in the follicular phase, i.e. prior to ovulation.
Maltese: Studju wieħed żgħir (n=58 mara bl-użu ta' disinn komuni) sab effikaċja komparabbli ta' 750 u 1500 mcg LNG bl-użu ta' tfixkil tal-ovulazzjoni bħala punt aħħari3 meta l-LNG ittieħed fil-fażi follikula, jiġifieri qabel lovulazzjoni.