FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that the findings from other randomised clinical trials and meta-analysis of randomised clinical trials (when the BART study is excluded) do not provide evidence of an association between aprotinin and perioperative mortality.
Maltese: Is-CHMP innota li s-sejbiet minn provi kliniċi randomizzati oħra u minn meta-analiżi ta' provi kliniċi randomizzati (meta l-istudju BART jiġi eskluż) ma jipprovdux evidenza ta' rabta bejn aprotinin u mortalità perioperattiva.
English: The CHMP considered that the efficacy of aprotinin has been clearly demonstrated in prospective randomised trials and meta-analysis of clinical trials which show that aprotinin reduces the incidence of massive bleeding, reduces the need for transfusion of blood products and reduces the need for resurgery for bleeding in patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB).
Maltese: Is-CHMP ikkunsidra li l-effikaċja ta' aprotinin intweriet b'mod ċar fi provi randomizzati prospettivi u minn meta-analiżi ta' provi kliniċi li juru li aprotinin inaqqas l-inċidenza ta' fsada massiva, inaqqas ilħtieġa għat-trasfużjoni ta' prodotti tad-demm u jnaqqas il-bżonn għal kirurġija mill-ġdid għal fsada f'pazjenti li għaddejjin minn kirurġija tal-qalb li jeħtieġu bypass kardjopulmonari (CPB).
English: Reduction in massive bleeding, transfusion need and risk for re-surgery due to bleeding are considered meaningful clinically important effects of aprotinin, and when considering the overall data on the known risks, the CHMP considered that the balance is clearly positive in the identified patient population.
Maltese: It-tnaqqis fi fsada massiva, ħtieġa ta' trasfużjoni u riskju ta' kirurġija mill-ġdid minħabba l-fsada huma kkunsidrati effetti klinikament importanti sinifikanti ta' aprotinin, u meta kkunsidra d-dejta globali u r-riskji magħrufa, is-CHMP ikkunsidra li l-bilanċ huwa pożittiv b'mod ċar fil-popolazzjoni ta' pazjenti identifikata.
English: A direct healthcare professional communication (DHPC) was agreed to provide prescribers with information on the review and an update on the safety information for aprotinin.
Maltese: Ġiet miftiehma komunikazzjoni professjonali diretta tal-kura tas-saħħa (DHPC) biex tipprovdi informazzjoni lil dawk li jippreskrivu dwar ir-reviżjoni u aġġornament dwar l-informazzjoni tas-sigurtà għal aprotinin.
English: A comprehensive review was undertaken and the CHMP concluded that the final BART study results were seriously compromised by several newly identified major methodological deficiencies, which were considered crucial to the validity and interpretation of the results.
Maltese: Saret reviżjoni komprensiva u s-CHMP ikkonkluda li r-riżultati finali tal-istudju BART kienu kompromessi serjament b'bosta nuqqasijiet metodoloġiċi maġġuri identifikati ġodda, likienu kkunsidrati kruċjali għall-validità u l-interpretazzjoni tar-riżultati.
English: There is no evidence of an association between aprotinin and perioperative mortality from randomised clinical trials when the BART study is excluded.
Maltese: M'hemm l-ebda evidenza ta' assoċjazzjoni bejn aprotinin u l-mortalità perioperattiva minn provi kliniċi aleatorji meta l-istudju BART ikun eskluż.
English: The CHMP noted the uncertainties and advised that the interpretation of all available data from observational studies is limited.
Maltese: Is-CHMP innota l-inċertezzi u ta parir li l-interpretazzjoni tad-dejta kollha disponibbli minn studji ta' osservazzjoni hija limitata.
English: • The Committee considered all data provided by the MAHs in writing and at the oral explanation, including data available from literature reviews and the outcome of a scientific advisory group.
Maltese: • Il-Kumitat ikkunsidra d-dejta kollha pprovduta mid-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq bil-miktub u waqt l-ispjegazzjoni orali, inkluż dejta disponibbli mir-reviżjonijiet taddokumentazzjoni u r-riżultat tal-laqgħa tal-grupp ta' konsulenza xjentifika.
English: • The Committee considered that the available randomised clinical trial and meta-analysis of clinical trials (when the BART study is excluded) do not give evidence of an association between aprotinin and perioperative mortality.
Maltese: • Il-Kumitat ikkunsidra li l-prova klinika randomizzata disponibbli u l-meta-analiżi ta' provi kliniċi (meta l-istudju BART jiġi eskluż) ma jagħtux xhieda ta' rabta bejn aprotinin u mortalità perioperattiva.
English: The MAHs will submit a revised protocol for the registry to national competent authorities.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jissottomettu protokoll rivedut għar-reġistru lill-awtoritajiet nazzjonali kompetenti.
English: A CHMP scientific advisory group (SAG) meeting was held in October 2011 and its views were considered by the CHMP in the framework of this review.
Maltese: F'Ottubru 2011 ġiet organizzata laqgħa tal-grupp ta' konsulenza xjentifika (SAG) tas-CHMP u lfehmiet li tqajmu fiha ġew ikkunsidrati mis-CHMP fil-qafas ta' din ir-reviżjoni.
English: Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available (see section 4.4 and 5.1).
Maltese: Aprotinin għandu jintuża biss wara kunsiderazzjoni xierqa tal-benefiċċji u tar-riskji, u l-kunsiderazzjoni li kura differenti hija disponibbli (ara sezzjoni 4.4 u 5.1).
English: Re-surgery due to bleeding carries high risk for increased morbidity which also was emphasised by the group of external experts consulted by the CHMP.
Maltese: Il-kirurġija mill-ġdid minħabba l-fsada iġġorr riskju għoli ta' żieda fil-morbidità li kienet enfasizzata wkoll mill-grupp ta' esperti esterni kkonsultati mis-CHMP.
English: The CHMP noted that since the initial review in 2007, more data has become available, such as new observational studies, the final study results of the BART study, and more importantly new analyses of the BART study.
Maltese: IsCHMP innota li mir-reviżjoni inizjali fl-2007, saret disponibbli aktar dejta, b'mod partikolari r-riżultati finali tal-istudju, u b'mod aktar importanti analiżi ġdida tal-istudju BART.
English: The deficiencies included the unexplained exclusion of patients from analysis, underlying differences in baseline characteristics between the study groups which were not homogenous in spite of randomisation, and the apparent reduced level of heparinisation in the aprotinin arm which would increase the risk of thrombogenic events in this group.
Maltese: In-nuqqasijiet kienu jinkludu lesklużjoni inspjegabbli ta' pazjenti mill-analiżi, differenzi sottostanti fil-karatteristiċi fil-linja bażi bejn il-gruppi tal-istudju li ma kinux omoġenji minkejja randomizzazzjoni, u t-tnaqqis evidenti fil-livell ta' eparinizzazzjoni fil-fergħa ta' aprotinin li żżid ir-riskju ta' avvenimenti tromboġeniċi f'dan il-grupp.
English: No firm conclusion on cardiovascular risks can be made on the BART study due to several serious methodological issues identified.
Maltese: Ma tista' ssir l-ebda konklużjoni soda dwar riskji kardjovaskulari abbażi tal-istudju BART minħabba diversi kwistjonijiet metodoloġiċi serji identifikati.
English: Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Maltese: Aprotinin huwa indikat għall-użu profilattiku biex jitnaqqas it-telf ta' demm u t-trasfużjoni tad-demm f'pazjenti adulti li qegħdin f'riskju għoli ta' telf maġġuri ta' demm li għaddejjin minn kirurġija iżolata ta' bypass graft tal-arterja koronarja (jiġifieri kirurġija ta' bypass graft tal-arterja koronarja li ma tkunx ikkombinata ma' kirurġija kardjovaskulari oħra).
English: The CHMP considered that a clarification should be included in the wording of the indication to reflect that the product should be used in patients undergoing CPB in the course of ‘isolated CABG' surgery, as efficacy and safety of aprotinin in more extensive surgery has not been sufficiently characterised.
Maltese: Is-CHMP ikkunsidra li għandha tkun inkluża kjarifika fil-kliem tal-indikazzjoni li tirrifletti li l-prodott għandu jintuża f'pazjenti għaddejjin minn CPB waqt kirurġija ‘iżolata ta' CABG', peress li l-effikaċja u s-sigurtà ta' aprotinin f'kirurġija aktar estensiva ma ġewx ikkaratterizzati biżżejjed.
English: A restricted distribution of aprotinin is envisaged with aprotinin available only to centres that perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry.
Maltese: Tqassim limitat ta' aprotinin huwa previst b'aprotinin ikun disponibbli biss għal ċentri li jagħmlu kirurġija kardijaka fuq bypass kardjopulmonari u li jimpenjaw ruħhom li jipparteċipaw fir-reġistru.
English: The proposed indication is for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Maltese: L-indikazzjoni proposta hija għall-użu profilattiku sabiex jonqos it-telf tad-demm u t-trasfużjonijiet tad-demm f'pazjenti adulti li huma f'riskju għoli ta' telf maġġuri ta' demm li jkunu għaddejjin minn kirurġija iżolata ta' bypass graft tal-arterja koronarja (jiġifieri kirurġija ta' bypass graft tal-arterja koronarja li ma tkunx ikkombinata ma' kirurġija kardjovaskulari oħra).
English: Taking the totality of data into account it is judged that the previous signal for an increased mortality associated with the use of aprotinin should be refuted provided that the drug is given in the identified target population of adult patients at high risk of major blood loss undergoing isolated coronary artery bypass graft (CABG) surgery and the recommendations for its use are followed.
Maltese: • Meta wieħed iqis id-dejta kollha, huwa meqjus li s-sinjal preċedenti għal żieda fil-mortalità assoċjata mal-użu ta' aprotinin huwa miċħud diment li aprotinin jingħata fil-popolazzjoni fil-mira identifikata ta' pazjenti adulti f'riskju għoli ta' telf maġġuri ta' demm li għaddejjin minn kirurġija iżolata ta' bypass graft tal-arterja koronarja (CABG) u r-rakkomandazzjonijiet dwar l-użu tiegħu jiġu segwiti.
English: New observational studies are now available and results showed that aprotinin did not affect in-hospital mortality, with one study reporting a statistically significant mortality ‘benefit' for aprotinin in high-risk cardiac surgery patients, compared with TXA.
Maltese: Issa studji ġodda ta' osservazzjoni huma disponibbli u r-riżultati wrew li aprotinin ma affettwax il-mortalità flisptar, bi studju wieħed jirrapporta "benefiċċju" statistikament sinifikanti ta' mortalità għal aprotinin f'pazjenti li għaddejjin minn kirurġija tal-qalb li qegħdin f riskju għoli, meta mqabbla ma' TXA.
English: The CHMP considered that a registry should be conducted by MAHs of aprotinin containing medicinal products affected by this review.
Maltese: Is-CHMP ikkunsidra li għandu jsir reġistru mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ta' prodotti mediċinali li fihom aprotinin affettwati minn din ir-reviżjoni.
English: The CHMP considered that overall the data provided illustrate the risks associated with inadequate monitoring of the anticoagulative effect of heparin administered in the CABG procedure.
Maltese: Is-CHMP ikkunsidra li b'mod ġenerali d-dejta pprovduta turi r-riskji assoċjati ma' monitoraġġ inadegwat tal-effett kontra l-koagulazzjoni tal-eparina mogħtija fil-proċedura CABG.
English: Other notable safety concerns include the identified risk for transient renal impairment, which is a well characterised unfavourable effect of treatment with aprotinin.
Maltese: Tħassib notevoli ieħor dwar is-sigurtà jinkludi r-riskju identifikat għal indeboliment renali temporanju, li huwa effett mhux favorevoli kkaratterizzat sew tal-kura b'aprotinin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/351/001-003
Maltese: FIS-SUQ EU/1/06/351/001-003
English: Warner Chilcott France Parc d'activité de la Grande Brèche 5 rue Désir Prévost 91070 Bondoufle
Maltese: Warner Chilcott France Parc d'activité de la Grande Brèche 5 rue Désir Prévost 91070
English: Endometrial effects
Maltese: Effetti endometrijali
English: The active substance is testosterone.
Maltese: Is-sustanza attiva hi testosterone.
English: Date of latest renewal: 28-July-2011
Maltese: Data ta' l-aħħar tiġdid: 28 ta' Lulju, 2011
English: Week 52 N Mean (SEM) N Mean (SEM) N Mean (SEM)
Maltese: N Medja (SEM) N Medja (SEM) N Medja (SEM)
English: The active metabolites of testosterone are estradiol and dihydrotestosterone (DHT).
Maltese: Ilmetaboliti attivi ta' testosterone huma estradiol u dihydrotestosterone (DHT).
English: Self adhesive matrix drug layer
Maltese: Saff tal-mediċina self adhesive matrix
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), jew rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid data disponibbli).
English: Testosterone is metabolised to various 17-ketosteroids and further metabolism results in inactive glucuronides and other conjugates.
Maltese: Testosterone hu metabolat għal diversi 17-ketosteroids u metaboliżmu addizzjonali jirriżulta fi glucuronides inattivi u konjugati oħrajn.
English: Also contains: Sorbitan oleate, 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone copolymer, E110, E180, copper phthalocyanine blue pigment, polyethylene, siliconised polyester film.
Maltese: Fiha ukoll: Sorbitan oleate, 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone copolymer, E110, E180, copper phthalocyanine blue pigment, polyethylene, siliconised polyester film.
English: MARKETING AUTHORISATION HOLDER Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4
Maltese: Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4
English: Consistent with the prevalence of HSDD, there are limited data above the age of 60.
Maltese: B'mod konsistenti mal-prevalenza ta' HSDD, hemm informazzjoni limitata fuq pazjenti li għandhom iktar minn 60 sena.
English: Thyroid hormone levels
Maltese: Livelli tal-ormoni tat-tirojde
English: Livensa is used to treat HSDD.
Maltese: Livensa jintuża għat-trattament ta' HSDD.
English: In this leaflet:
Maltese: Per eżempju:
English: Cartons of 2, 8 and 24 patches.
Maltese: Kaxxi tal-kartun ta' 2, 8 u 24 garżi.
English: Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4.
Maltese: L-androġeni jistgħu jnaqqsu l-livelli ta' globulin li teħel ma' thyroxin, li jirriżulta f'livelli totali mnaqqsa ta' T4 fis-serum, u f'żieda fit-teħid tar-reżina ta' T3 u T4.
English: Patients treated with conjugated equine estrogen (CEE) are not recommended to use Livensa, as efficacy has not been demonstrated (see sections 4.4 and 5.1).
Maltese: Pazjenti trattati b'conjugated equine estrogen (CEE) mhumiex rakkomandati li jużaw Livensa, għax l effikaċja ma ntwerietx (ara sezzjonijiet 4.4 u 5.1).
English: Do not refrigerate or freeze.
Maltese: Neħħi l garża.
English: Siliconised polyester film.
Maltese: Rita tal-polyester, siliconised.
English: The other ingredients are: Sorbitan oleate, 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone co-polymer.
Maltese: Sorbitan oleate, 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone co-polymer.
English: Little information is available on the effects of testosterone on the endometrium.
Maltese: Ftit informazzjoni hi disponibbli fuq l-effetti ta' testosterone fuq l-endometriju.
English: If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Livensa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table.
Maltese: Jekk reazzjoni avversa seħħet fi frekwenza ogħla fl-istudji integrati ta' fazi III (pazjenti fuq Livensa n=1,498, pazjenti fuq il-plaċebo n=1,297), din il-frekwenza hi rrappurtata fit-tabella.
English: Translucent polyethylene backing film sunset yellow FCF (E110) latolrubine BK (E180) copper phthalocyanine blue pigment.
Maltese: Rinforz fid-dahar transluċidu tal-polyethylene Linka tal-istampar sunset yellow FCF (E110) latolrubine BK (E180) copper phthalocyanine blue pigment.
English: The following pack sizes are available: 2, 8 and 24 patches.
Maltese: Id-daqsijiet tal-pakkett li ġejjin huma disponibbli: 2, 8 u 24 garżi.
English: In the combined phase III data, excluding patients taking oral CEE, in whom there was no significant improvement in sexual function, 50.7 % of women (n=274) treated with Livensa and 29.4 % of those treated with placebo (n=269) were responders with regard to total satisfying sexual activity (primary endpoint), when a responder was predefined as having an increase in the 4-week frequency of satisfying activities of > 1.
Maltese: III, li jeskludi l-pazjenti li kienu qed jieħdu CEE orali, li fihom ma kien hemm l-ebda titjib sinifikanti fil-funzjoni sesswali, 50.7% tan-nisa (n=274) trattati b'Livensa u 29.4% ta' dawk trattati bil-plaċebo (n=269) irrispondew rigward l-attività sesswali li tissodisfa (riżultat aħħari primarju), meta min irrisponda kien definit minn qabel bħala li kellha żieda fuq medda ta' 4-ġimgħat fil-frekwenza ta' attivitajiet li jissodisfaw ta' > 1.
English: Livensa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Maltese: Livensa hu terapija transdermali għal HSDD, li ttejjeb ix-xewqa sesswali filwaqt li tilħaq konċentrazzjonijiet tat-testosterone li huma kompatibbli ma' livelli ta' qabel il-menopawsa.
English: Metabolism and nutrition
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: In women, circulating testosterone is primarily bound in the serum to SHBG (65-80 %) and to albumin (20-30 %) leaving only about 0.5-2 % as the free fraction.
Maltese: Fin-nisa, it-testosterone li jiċċirkola jeħel primarjament fis-serum ma' SHBG (65-80%) u ma' lalbumina (20-30%), u jħalli biss madwar 0.5-2% bħala l-porzjon ħieles.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, androgens, ATC
Maltese: Ormoni tas-sess u modulatori tas-sistema ġenitali, adroġeni, Kodiċi ATC:
English: The amount of SHBG and albumin in serum and the total testosterone concentration determine the distribution of free and bioavailable testosterone.
Maltese: L-ammont ta' SHBG u albumina fis-serum u lkonċentrazzjoni totali ta' testosterone, tiddetermina d-distribuzzjoni ta' testosterone ħieles u dak bijodisponibbli.
English: The sachet material comprises of food grade paper/LDPE/aluminium foil/ethylene methacrylic acid copolymer (outer to inner layer).
Maltese: Il-materjal tal-qartas jinkludi karta tal-grad ta' likel/LDPE/fojl ta' l-aluminju/ethylene methacrylic acid copolymer (saff ta' barra sa ġewwa).
English: - anxiety - disturbance in attention - dysgeusia (distorted sense of taste) - impaired balance - hyperaesthesia (abnormal increase in sensitivity to stimuli of the senses) - oral paraesthesia (tingling or numb sensation in the mouth) - transient ischemic attack (mini stroke) - diplopia (double vision) - eye redness - palpitations (rapid and irregular heart beat) - nasal congestion - throat tightness - diarrhoea - dry mouth - nausea - eczema - increased sweating - rosacea (redness of the face) - arthritis - breast cyst - clitoral engorgement - genital pruritus (genital itching sensation) - vaginal burning sensation - anasarca (widespread swelling of the skin) - asthenia (lack of energy and strength) - chest tightness - chest discomfort - abnormal blood fibrinogen (abnormal blood clotting) - increased heart rate - increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides (all measures of liver
Maltese: - jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għat-testosterone jew sustanzi oħra ta' Livensa (ara s-sezzjoni ‘Aktar tagħrif' fl-aħħar ta' dan il-fuljett). - jekk taf li kellek fil-passat, jekk għandek, jew jekk taħseb li jista' jkollok, kanċer tas-sider jew kwalunkwe kanċer ieħor li t-tabib tiegħek iddeskriva li kien ikkawżat jew stimulat mill-ormon femminili, l-estroġenu, imsejħin ukoll kanċers ‘dipendenti fuq l-estroġenu'. - jekk inti għandek kundizzjonijiet oħrajn li t-tabib tiegħek jista' jikkunsidra li mhumiex adattati għall-użu ta' l-estroġenu u/jew tat-testosterone.
English: Step 1 Tear open the sachet.
Maltese: Pass 1 Iftaħ il-qartas.
English: In premenopausal women, the rate of production of testosterone is 100 to 400 micrograms/24 hours, of which half is contributed by the ovary as either testosterone or a precursor.
Maltese: F'nisa qabel ma jkollhom il-menopawsa, ir-rata ta' produzzjoni ta' testosterone hi ta' 100 sa 400 mikrogramma/24 siegħa, li minnhom, in-nofs jiġi kkontribwit mill-ovarji bħala jew testosterone jew prekursur.
English: In the combined study analysis at 24 weeks, the difference in the mean frequency of total satisfying episodes between Livensa and placebo was 1.07 per 4 weeks.
Maltese: Fl-analiżi ta' l-istudju kombinat wara 24 ġimgħa, id-differenza fil-medja tal-frekwenza ta' episodji totali li jissodisfa bejn Livensa u l-plaċebo kienet ta' 1.07 kull 4 ġimgħat.
English: Livensa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Maltese: Livensa ma nfluwenzax il-konċentrazzjonijiet fis-serum tas-sex hormone binding globulin (SHBG),
English: Acrylic co-polymer adhesive containing 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone co-polymer.
Maltese: Sustanza li twaħħal ta' l-acrylic co-polymer li fiha 2-Ethylhexylacrylate - 1-Vinyl-2-pyrrolidone copolymer.
English: The efficacy of Livensa is reduced if your estrogen therapy is of a certain type (‘conjugated equine estrogens').
Maltese: L-effikaċja ta' Livensa titnaqqas jekk it-terapija tiegħek bl-estroġenu tkun ta' ċertu tip (‘conjugated equine estrogens').
English: Total satisfying sexual activity (primary endpoint), sexual desire, and distress associated with low sexual desire (secondary endpoints) were evaluated with validated instruments.
Maltese: Attività sesswali totali li tissodisfa (riżultat aħħari primarju), xewqa sesswali, u problemi marbuta ma' xewqa sesswali baxxa (riżultati aħħari sekondarju) kienu evalwati bi strumenti vverifikati.
English: Translucent polyethylene backing film printed with ink containing sunset yellow FCF (E110), latolrubine BK (E180) and copper phthalocyanine blue pigment.
Maltese: Rinforz fid-dahar transluċidu tal-polyethylene, stampat b'linka li fiha sunset yellow FCF (E110), latolrubine BK (E180) u copper phthalocyanine blue pigment.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan (RMP) dated 19-September-2010, presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jimpenja ruħu li jwettaq l-istudji u lattivitajiet addizzjonali ta' farmakovigilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, biddata ta' 19 ta' Settembru, 2010, inkluz f' Modulu 1.8.2 tal-awtorizzazzjoni għat-Tqegħid fis-Suq u aġġornamenti sussegwenti tas-Sistema ta' l-Immaniġġar tar-Riskju kif deciż mill-Kumitat ghall-Prodotti Mediċinali għall-Użu Uman ta' l-Aġenzija Ewropeja dwar il-Mediċini (CHMP).
English: Subgroup analyses suggested that the route and type of concomitant estrogen (transdermal oestradiol, oral conjugated equine estrogen (CEE), oral non-CEE) can influence patient response.
Maltese: L-analiżi tas-sotto-gruppi ssuġġerew li r-rotta u t-tip ta' użu fl-istess ħin ta' l-estroġenu (oestradiol transdermali, conjugated equine estrogen (CEE) orali, u non-CEE orali) jistgħu jinfluwenzaw ir rispons tal-pazjent.