FrancophonIA/ELRC3.0 huggingface dataset:
English: The Cochrane review (Lethaby et al 2004) and analysis of available observational data (Anderson 2003, Beresford 97, Jain 2000, Hill 2000, Hully 98, MWS 2005, Newcomb 2003, Pike 97, Pukkala 2001, Weiderpass 99) suggest that addition of progestogen for at least 12 days per cycle reduces, but may not completely eliminate, the increased incidence of endometrial cancer caused by unopposed oestrogens; and that combined continuous HRT does not increase the risk of endometrial cancer.
Maltese: L-analiżi Cochrane (Lethaby et al 2004) u l-analiżi ta' dejta minn osservazzjonijiet disponibbli (Anderson 2003, Beresford 97, Jain 2000, Hill 2000, Hully 98, MWS 2005, Newcomb 2003, Pike 97, Pukkala 2001, Weiderpass 99) jissuġġerixxu li ż-żieda ta' proġestoġen għal ta' l-anqas 12-il jum f'kull ċiklu tnaqqas, iżda tista' ma teliminax kompletament iż-żieda fl-inċidenza tal-kanċer endometrijali ikkawżat minn estroġeni mhux opponuti, u li HRT ikkombinat kontinwu ma jżidx ir-riskju ta' kanċer endometrijli.
English: This means that the doses of E2 and NETA are decreased by 50% and 80%, respectively.
Maltese: Dan ifisser li d-dożi ta' E2 u NETA jitnaqqsu b'50% u 80%, rispettivament.
English: • Epilepsy
Maltese: • Epilessija
English: Noviana film-coated tablets
Maltese: Noviana filmcoated tablets
English: • Porphyria
Maltese: • Porfirja
English: Estradiol: The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Maltese: Estradiol:Is-sustanza attiva, 17ß-estradiol, hija identika kimikament u bijoloġikament għallestradiol uman endoġenu.
English: Vulvovaginal mycotic infection
Maltese: Infezzjoni mikotika vulvo-vaġinali
English: DK-2880 Bagsvaerd Denmark
Maltese: DK-2880
English: • Medicines used for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
Maltese: • Mediċini użati għall-epilessija (bħal phenobarbital, phenytoin, u carbamazepine)
English: The metabolism of oestrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepin) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Maltese: cytochrome P450 bħal mediċini kontra l-konvulżjonijiet (eż. phenobarbital, phenytoin, carbamazepin) u mediċini kontra l-infettar (eż. rifampicin, rifabutin, nevirapine, efavirenz).
English: Oestrogen and progestagen for continuous combined hormone replacement therapy (HRT).
Maltese: Estroġenu u proġestoġenu għal terapija ta' sostituzzjoni bl-ormoni kombinati u kontinwi (HRT).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletrali u tattessut konnettiv
English: • Leiomyoma (uterine fibroids) or endometriosis
Maltese: • Leijomijoma (fibrojdi fl-utru) jew endometrijosi
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, and ceruloplasmin).
Maltese: Proteini oħra fil-plażma jistgħu jiżdiedu (subtrat ta' angiotensinogen/renin, alphaI-antitrypsin, u ceruloplasmin).
English: Generally recognised risk factors for VTE include a personal history or family history, severe obesity (Body Mass Index > 30 kg/m2) and systemic lupus erythematosus (SLE).
Maltese: Fatturi ta' riskju in-ġenerali rikonoxxuti ta' VTE jinkludu l-istorja personali jew l-istorja talfamilja, obeżità severa (Indiċi tal-Massa tal-Ġisem > 30 kg/m2) u lupus eritematosu sistemiku (SLE).
English: For oestrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which >80% of HRT use was oestrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95%CI 1.21 - 1.49) and 1.30 (95%CI 1.21 - 1.40), respectively.
Maltese: Għall-HRT b'estroġenu biss, l-istimi ta' riskju relattiv (RR) minn analiżi mill-ġdid ta' dejta oriġinali minn 51 studju epidemjoloġiku (fejn >80% ta' l-użu tal-HRT kien b'estroġenu biss) u mill-Istudju epidemjoloġiku ta' Miljun Mara (MWS) huma simili b'1.35 (95%CI 1.21 - 1.49) u 1.30 (95%CI 1.21 - 1.40), rispettivament.
English: The objective of this study was to determine the endometrial safety of 2 years of treatment with low CEE doses (0.3, 0.45 and 0.625 mg).
Maltese: L-objettiv ta' dan l-istudju kien li jiddetermina s-sigurtà endometrijali ta' sentejn trattament b'dożi baxxi ta' CEE (0.3, 0.45 u 0.625 mg).
English: White, round, biconvex tablets with a diameter of 6 mm.
Maltese: Pilloli bojod, tondi, konvessi b'dijametru ta' 6 mm.
English: • Cholelithiasis
Maltese: • Kolelitijasi
English: The reporting rate of these spontaneous adverse drug reactions is very rare (<1/10,000 patient years).
Maltese: Ir-rata ta' rrapportar ta' dawn ir-reazzjonijiet avversi spontanji tal-mediċina hija rari ħafna (<1/10,000 sena tal-pazjenti kollha).
English: Vulvovaginal mycotic infection, see also “Reproductive system and breast disorders
Maltese: Infezzjoni mikotika vulvo-vaġinali, ara wkoll "Disturbi fissistema riproduttiva u fis-sider"
English: - The proportion of proliferative endometrium (71%) was higher, on the contrary the proportion of atrophic endometrium was lower (19%) than expected for a continuous combination.
Maltese: - Il-proporzjon ta' endometriju proliferattiv (71%) kien ogħla; għall-kuntrarju, il-proporzjon ta' endometriju atrofiku kien inqas (19%) milli mistenni mill-kombinazzjoni kontinwa.
English: The WHI trial reported a risk estimate of 1.24 (95%CI 1.01 - 1.54) after 5.6 years of use of oestrogenprogestagen combined HRT (CEE + MPA) in all users compared with placebo.
Maltese: Il-prova WHI irrapportat stima ta' riskju ta' 1.24 (95%CI 1.01 - 1.54) wara 5.6 snin ta' użu ta' HRT ikkombinat minn estroġenu-proġestoġenu (CEE + MPA) f'dawk kollha li għamlu użu minnu meta mqabbla mal-plaċebo.
English: At high doses of norethisterone embryo-lethal effects were observed.
Maltese: F'dożi għoljin, ġie osservat li norethisterone kellu effetti letali fuq l-embriju.
English: Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.
Maltese: It-tabib se jispjegalek x'jiġri meta twaqqaf il-kura u jiddiskuti possibilitajiet oħra miegħek.
English: Pharmacotherapeutic group: Progestogens and estrogens, fixed combinations, ATC code: G03FA01
Maltese: Proġestoġeni u estroġeni, kombinazzjonijiet fissi, Kodiċi ATC:
English: The referral under article 29(4) of directive 2001/83/EC was notified to the CHMP on March 3rd, 2008 as Germany and France did not consider the application acceptable.
Maltese: Ir-riferiment skond l-Artikolu 29(4) tad-Direttiva 2001/83/KE kien innotifikat lis-CHMP fit-3 ta' Marzu, 2008 billi l-Ġermanja u Franza ma qisux l-applikazzjoni bħala waħda aċċettabbli.
English: - the endometrial safety of Activelle 0.5mg estradiol/0.1mg NETA product is sufficiently supported from the submitted data.
Maltese: - is-sigurtà endometrijali tal-prodott Activelle 0.5mg estradiol/0.1mg NETA hija appoġġjata b'mod suffiċjenti bid-dejta sottomessa.
English: France - Activelle 0,5 mg/0,1 mg comprimé pelliculé Germany - Noviana
Maltese: Franza - Activelle 0,5 mg/0,1 mg comprimé pelliculé Il-Ġermanja - Noviana
English: Hungary - Noviana filmtabletta
Maltese: L-Ungerija - Noviana filmtabletta
English: • Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
Maltese: • Mard trombo-emboliku arterjali attiv jew riċenti (eż. anġina, infart mijokardijaku)
English: Summary of CHMP Opinion
Maltese: Sommarju ta' l-Opinjoni tas-CHMP
English: The MWS reported that, compared to never users, the use of various types of oestrogen-progestagen combined HRT was associated with a higher risk of breast cancer (RR = 2.00, 95%CI 1.88 - 2.12) than use of oestrogens alone (RR = 1.30, 95%CI 1.21 - 1.40) or use of tibolone (RR=1.45, 95%CI
Maltese: L-MWS irrapporta li, imqabbel ma' minn qatt ma għamel użu minnhom, l-użu ta' tipi varji ta' HRT ikkombinat minn estroġenu-proġestoġenu kien assoċjat ma' riskju ogħla ta' kanċer tas-sider (RR = 2.00, 95%CI 1.88 - 2.12) mill-użu ta' estroġenu waħdu (RR = 1.30, 95%CI 1.21 - 1.40) jew użu ta' tibolone (RR=1.45, 95%CI 1.25 - 1.68).
English: Other side effects of combined HRT
Maltese: Effetti sekondarji oħra b'HRT kombinata
English: Between 5 and 7 (best estimate = 6) for 5 years' use
Maltese: Bejn 5 u 7 (l-aħjar stima = 6) għall-użu ta' 5 snin
English: The only trial that studied the 0.1 mg NETA dose was the Novo Nordisk study KLIM/PD/7/USA , which some CHMP members considered to be inconclusive.
Maltese: L-unika prova li studjat id-doża ta' 0.1 mg NETA kien listudju ta' Novo Nordisk KLIM/PD/7/USA, li xi membri tas-CHMP qiesu bħala wieħed inkonklussiv.
English: After administration of two Activelle tablets, the average peak plasma concentration was 24 pg/ml (CV 38 %).
Maltese: Wara t-teħid ta' żewġ pilloli ta' Activelle, ilmedja ta' l-ogħla konċentrazzjoni fil-plażma kienet ta' 24 pg/ml (CV 38 %).
English: The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery.
Maltese: Ir-riskju ta' VTE jista' jiżdied temporanjament b'immobilizzazzjoni fit-tul, trawma maġġuri jew kirurġija maġġuri.
English: Slovakia - Noviana filmom obalené tablety
Maltese: Is-Slovenja - Noviana filmsko obložene tablete Is-Slovakkja - Noviana filmom obalené tablety
English: • Migraine (see “Stop taking Activelle” in section 2)
Maltese: • Emigranja (ara “Ieqaf tieħu Activelle” f'sezzjoni 2)
English: • Myocardial infarction and stroke
Maltese: • Infart mijokardijaku u puplesija
English: • Medicines used for HIV infections (such as nevirapine, efavirenz, ritonavir and nelfinavir)
Maltese: • Mediċini użati għall-infezzjonijiet bl-HIV (bħal nevirapine, efavirenz, ritonavir u nelfinavir)
English: The dose-dependency of the proliferative effect of unopposed oestrogens on the endometrium was sustained by data from the KLIM/PD/11/USA trial for E2 (0.5 mg and 1 mg) and from Pickar et al for conjugated equine oestrogens (CEE, 0.3 to 0.625 mg).
Maltese: Id-dipendenza fuq id-doża ta' l-effett proliferativ ta' l-estroġeni mhux opponuti fuq l-endometriju issaħħet b'dejta mill-prova KLIM/PD/11/USA għal E2 (0.5 mg u 1 mg) u minn Pickar et al għal estroġeni ta' ekwini konġugati (CEE, minn 0.3 sa 0.625 mg).
English: (endometrial cancer)
Maltese: emboliżmu pulmonari)
English: Data on a limited number of exposed pregnancies indicate adverse effects of norethisterone on the foetus.
Maltese: Dejta fuq numru limitat ta' tqalat esposti jindikaw effetti avversi ta' norethisterone fuq il-fetu.
English: In the present study, 7 samples had insufficient tissue and endometrial thickness > 4mm (the cut-off point for endometrial thickness was 4 mm).
Maltese: Fl-istudju attwali, seba' kampjuni kellhom tessut insuffiċjenti u ħxuna endometrijali > 4mm (il-punt kruċjali għall-ħxuna endometrijali kien 4 mm).
English: Between 3 and 7 (best estimate = 5) for 10 years' use.
Maltese: Bejn 3 u 7 (l-aħjar stima = 5) għall-użu ta' 10 snin.
English: There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated oestrogens and medroxyprogesterone acetate (MPA).
Maltese: Minn provi kliniċi kkontrollati tat-tip randomised m'hemmx evidenza ta' benefiċċji kardjovaskulari b' estroġeni kkonjugati, ikkombinati u kontinwi u medroxyprogesterone acetate (MPA).
English: Depression or depression aggravated
Maltese: Depressjoni jew depressjoni ggravata
English: • Oestrogen-dependent neoplasms benign and malignant, e.g. endometrial cancer
Maltese: • Neoplasmi beninji u malinni dipendenti mill-estrogenu, eż. kanċer ta' l-endometriju
English: LIST OF EXCIPIENTS Activelle contains lactose.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Activelle fih lactose.
English: The experience of treating women older than 65 years is limited.
Maltese: L-esperjenza ta' kura fin-nisa ta' aktar minn 65 sena hija limitata.
English: For 1000 women who used oestrogen + progestagen combined HRT (CEE + MPA), the number of additional cases would be o Between 0 and 9 (best estimate = 4) for 5 years' use.
Maltese: Għal 1000 mara li użat HRT ikkombinat minn estroġenu + proġestoġenu (CEE + MPA), in-numru ta' każijiet addizzjonali jkunu o Bejn 0 u 9 (l-aħjar stima = 4) għall-użu ta' 5 snin.
English: - The endometrial safety data is not in accordance with the European guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in post menopausal women (EMEA/CHMP/021/97 rev1).
Maltese: - Id-dejta tas-sigurtà endometrijali mhix konformi mal-linja gwida Ewropea dwar linvestigazzjoni klinika ta' prodotti mediċinali għat-terapija tar-rimpjazzament ta' l-ormoni għassintomi tad-defiċjenza ta' l-estroġenu f'nisa ta' wara l-menopawża (EMEA/CHMP/021/97 rev1).
English: • The active substances are estradiol and norethisterone acetate.
Maltese: - Is-sustanzi attivi huma estradiol u norethisterone acetate.
English: According to this recommendation, the applicant provided data from a trial (KLIM/PD/7/USA) which studied endometrial safety of the combination of E2 1 mg and NETA 0.1 mg.
Maltese: Skond din ir-rakkomandazzjoni, l-applikant ipprovda dejta minn prova (KLIM/PD/7/USA) li studjat is-sigurtà endometrijali tal-kombinazzjoni ta' 1 mg E2 u 0.1 mg NETA 0.1 mg.
English: For 1000 women in the placebo group,
Maltese: Għal 1000 mara fil-grupp tal-plaċebo,
English: • Itching or urticaria.
Maltese: • Hakk u urtikarja
English: Vaginal haemorrhage
Maltese: Emorraġija vaġinali
English: Activelle 0.5 mg/0.1 mg is a continuous combined hormone replacement therapy (HRT) product containing 0.5 mg estradiol (E2) and 0.1 mg norethisterone acetate (NETA).
Maltese: Activelle 0.5 mg/0.1 mg huwa prodott tat-terapija tar-rimpjazzament ta' l-ormoni kombinata kontinwa (HRT) li fih 0.5 mg estradiol (E2) u 0.1 mg norethisterone acetate (NETA).
English: c. Continuous combined therapy versus sequential therapy in the prevention of endometrial hyperplasia or carcinoma
Maltese: Terapija kontinwa kombinata mqabbla ma' terapija sekwenzjali fil-prevenzjoni ta' liperplażja jew karċinoma endometrijali
English: Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radio-immunoassay).
Maltese: L-estroġeni jżidu l-globulina li teħel mat-tirojde (TBG), li twassal għal żieda ta' l-ormon tattirojde totali fiċ-ċirkulazzjoni, kif imkejjel bil-jodju imwaħħal mal-proteini (PBI), bil-livelli ta' T4 (permezz ta' analiżi b'kolonna jew radju-immunassaġġ) jew bil-livelli ta' T3 (permezz ta' radjuimmunassaġġ).
English: However, the some members of the CHMP noted that this trial failed to demonstrate the endometrial safety of the combination of E2 1 mg and NETA 0.1 mg, as the upper limit of the two-sided 95% confidence interval of the observed frequency of endometrial hyperplasia was 2.90% and then exceeded the acceptable limit of 2%.
Maltese: Madankollu, l-istess membri tas-CHMP innotaw li din il-prova naqset milli turi s-sigurtà endometrijali tal-kombinazzjoni ta' 1 mg E2 u 0.1 mg NETA, billi l-limitu massimu ta' l-intervall tal-kunfidenza ta' 95% b'żewġ naħat tal-frekwenza osservata ta' l-iperplażja endometrijali kien 2.90% u għalhekk qabeż il-livell aċċettabbli ta' 2%.
English: • Asthma
Maltese: • Ażma
English: - Pooled data from several recently authorized sequential and continuous oestrogen/progestin HRT combinations in Europe show that the incidence of hyperplasia or more serious adverse endometrial outcomes was approximately 0.26% during the first year of treatment, that is well under the observed hyperplasia incidence of 0.8% in the KLIM/PD/7/USA trial.
Maltese: - Id-dejta miġmugħa minn bosta kombinazzjonijiet tal-HRT bl-estroġenu/proġestin sekwenzjali u kontinwi awtorizzati riċentement turi li l-inċidenza ta' l-iperplażja jew konsegwenzi endometrijali iktar serji kienu bejn wieħed u ieħor 0.26% matul l-ewwel sena ta' trattament, jiġifieri ferm inqas mill-inċidenza osservata ta' l-iperplażja ta' 0.8% fil-prova KLIM/PD/7/USA.
English: 6.5 Nature and contents of container 1 x 28 tablets or 3 x 28 tablets in calendar dial packs.
Maltese: 1 x 28 pillola jew 3 x 28 pillola f'pakketti bil-kalendarju u li fihom werrej.
English: As for the KLIM/PD/11/USA trial, sample size may be considered too low to draw definite conclusion with regard to endometrial safety.
Maltese: Rigward ilprova KLIM/PD/11/USA, id-daqs tal-kampjun jista' jitqies żgħir wisq biex iwassal għal konklużjoni definita dwar is-sigurtà endometrijali.
English: The class “disordered proliferative” used in study KLIM/PD/7/USA is not well defined and not usually recognized.
Maltese: Il-klassi “proliferattiva diżordnata” użata fl-istudju KLIM/PD/7/USA mhijiex definita sew u normalment mhijiex rikonoxxuta.
English: Based on several other studies of various doses of 1) unopposed oestrogens, 2) oestrogen-progestogen sequential combinations and 3) oestrogen-progestogen continuous combinations, the CHMP considered it reasonable and scientifically acceptable to extrapolate that this low dose continuous oestrogen-progestogen combination would result in a considerably lower rate of endometrial hyperplasia than seen with a combination containing twice the oestrogen dose.
Maltese: Abbażi ta' diversi studji oħrajn ta' diversi dożi ta' 1) estroġeni mhux opponuti, 2) kombinazzjonijiet sekwenzjali ta' estroġenu-proġestoġen u 3) kombinazzjonijiet kontinwi ta' estroġenu-proġestoġen, is-CHMP qies li kien raġonevoli u xjentifikament aċċettabbli li jestrapola li din id-doża baxxa ta' kombinazzjoni kontinwa ta' estroġenu-proġestoġen kienet se tirriżulta f'rata konsiderevolment iktar baxxa ta' iperplażja endometrijali minn dik li dehret f'kombinazzjoni li fiha d-doppju tad-doża ta' l-estroġenu.
English: Very common side effects • Vaginal bleeding.
Maltese: Effetti sekondarji komuni ħafna • Fsada vaġinali
English: Activelle 0.5 mg/0.1 mg is a continuous combined HRT that contains the half dose of estradiol (E2) and the fifth of the dose of norethisterone acetate (NETA) that in the known fixed combination Activelle (E2 1 mg/NETA 0.5 mg).
Maltese: Activelle 0.5 mg/0.1 mg huwa HRT kontinwu kombinat li fih in-nofs doża ta' estradiol (E2) u 1/5 tad-doża ta' norethisterone acetate (NETA) fil-kombinazzjoni fissa magħrufa ta' Activelle (E2 1 mg/NETA 0.5 mg).
English: Novo Nordisk Farma B.V. Flemingweg 18
Maltese: Novo Nordisk Farma B.V.
English: • Other ingredients are: Lactose monohydrate, maize starch, hydroxypropylcellulose, magnesium stearate, hypromellose, triacetin and talc.
Maltese: - Is-sustanzi l-oħra huma Lactose monohydrate, maize starch, hydroxypropylcellulose,
English: Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT four to six weeks earlier, if possible.
Maltese: Fejn huwa probabbli li immobilizzazzjoni fit-tul issegwi kirurġija elettiva, partikolarment kirurġija addominali jew ortopedika fir-riġlejn, għandu jiġi kkunsidrat li jitwaqqaf temporanjament l-HRT minn erba' sa sitt ġimgħat qabel, jekk ikun possibbli.
English: After oral administration of an Activelle tablet, norethisterone acetate is rapidly absorbed and transformed to norethisterone (NET).
Maltese: Wara t-teħid ta' pillola ta' Activelle, norethisterone acetate jiġi assorbit malajr u mbiddel f'norethisterone (NET).
English: According to the guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women (EMEA/CHMP/021/97 Rev. 1) endometrial safety has to be demonstrated unequivocally before approval.
Maltese: Skond il-linja gwida ta' l-investigazzjoni klinika tal-prodotti mediċinali għat-terapija tarrimpjazzament ta' l-ormoni tas-sintomi tad-defiċjenza tal-estroġenu f'nisa ta' wara l-menopawża (EMEA/CHMP/021/97 Rev. 1), is-sigurtà endometrijali trid tintwera b'mod inekwivokabbli qabel l-approvazzjoni.
English: • Nervous system disorders: Dizziness
Maltese: • Disturbi fis-sistema nervuża:
English: Herbal preparations containing St John's Wort (Hypericum perforatum) may induce the metabolism of oestrogens and progestagens.
Maltese: Preparazzjonijiet mill-ħxejjex li fihom St John's Wort (Hypericum perforatum) jistgħu jistimolaw il-metaboliżmu ta' l-estroġeni u talproġestoġeni.
English: The most important metabolites are isomers of 5α-dihydro-NET and of tetrahydro-NET, which are excreted mainly in the urine as sulfate or glucuronide conjugates.
Maltese: L-aktar metaboliti importanti huma l-isomeri ta' 5α-dihydro-NET u ta' tetrahydro-NET, li jiġu mneħħija l-iżjed fl-awrina bħala konġjugati sulfati u glukuronidi.
English: There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65.
Maltese: Hemm ftit evidenza mill-prova ta' WHI ta' żieda fir-riskju ta' dimenzja probabbli f'nisa li jibdew jużaw CEE kontinwi u kkombinati u MPA wara l-età ta' 65 sena.
English: Amenorrhoea (no bleeding or spotting) was seen in 89% of the women in month 6 of treatment.
Maltese: Fis-6 xahar ta' kura 89 % tan-nisa kellhom amenorreja (ebda dmija jew taqtir).
English: Personal or strong family history of thromboembolism, or recurrent spontaneous abortion, should be investigated in order to exclude a thrombophilic predisposition.
Maltese: Storja personali jew storja b'saħħitha tal-familja ta' tromboemboliżmu, jew abort spontanju rikorrenti, għandha tiġi investigata sabiex tiġi eskluża predispożizzjoni trombofilika.
English: Between 0 and 3 (best estimate = 1.5) for 5 years' use
Maltese: Bejn 0 u 3 (l-aħjar stima = 1.5) għall-użu ta' 5 snin
English: The CHMP noted that the applicant had provided the following arguments to support the endometrial safety of Activelle 0.5 mg/0.1 mg:
Maltese: Is-CHMP innota li l-applikant kien ipprovda dawn l-argumenti biex jappoġġja s-sigurta endometrijali ta' Activelle 0.5 mg/0.1 mg:
English: The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to oestrogen-progestagen combined HRT (CEE + MPA) per 10,000 women years.
Maltese: Il-prova WHI ikkalkolat li wara 5.6 snin ta' investigazzjonijiet ta' wara f'nisa bejn l-etajiet ta' 50 u 79 sena, 8 każi addizzjonali ta' kanċer tas-sider li jinfirex ikun minħabba HRT ikkombinat minn estroġenu-proġestoġenu (CEE + MPA) kull 10,000 sena tan-nisa kollha.
English: 1 x 28 film-coated tablets 3 x 28 film-coated tablets
Maltese: 1 x 28 pillola miksija b'rita 3 x 28 pillola miksija b'rita [Biex timtela mill-pajjiż partikolari]
English: The pharmacokinetics of estradiol is not influenced by norethisterone acetate.
Maltese: Il-farmakokinetika ta' estradiol m'hijiex influwenzata minn norethisterone acetate
English: HRT may add to this risk.
Maltese: L-HRT jista' jżid ma' dan ir-riskju.
English: • Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura
Maltese: • Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda: kloasma, eritema multiforme, eritema nodosum, purpura vaskulari
English: The following adverse reactions have been reported in the literature in association with oestrogen/progestagen treatment:
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrapportati fil-letteratura b'assoċjazzjoni mal-kura b'estroġenu/ proġestoġenu:
English: Estradiol (as hemihydrate) 0.5 mg + Norethisterone acetate 0.1 mg
Maltese: Estradiol (bħal hemihydrate) 0.5 mg + Norethisterone acetate 0.1 mg
English: HRT is associated with a higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Maltese: L-HRT huwa assoċjat ma' riskju relattiv ogħla ta' żvilupp ta' trombo-emboliżmu tal-vini (VTE), jiġifieri trombożi tal-vini fondi jew emboliżmu pulmonari.