FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant was asked to provide any additional data, from clinical and observational studies, of relevance for the effects of continuous oestrogen-progestogen combined products on endometrial hyperplasia or endometrial cancer.
Maltese: L-applikant intalab jipprovdi dejta addizzjonali, minn studji kliniċi u ta' osservazzjoni, ta' relevanza għall-effetti fuq prodotti b'kombinazzjonijiet kontinwi ta' estroġenu-proġestoġen fuq liperplażja endometrijali jew il-kanċer endometrijali.
English: Bleeding with Activelle
Maltese: X'INHU ACTIVELLE
English: Additional data on effects of continuous oestrogen -progestogen combined products on emdometrial hyperplasia.
Maltese: Dejta addizzjonali fuq l-effetti ta' prodotti b'kombinazzjonijiet kontinwi ta' estroġenuproġestoġen fuq l-iperplażja kombinata.
English: a. the proliferative effect of unopposed oestrogens on the endometrium is dose-dependant, b. this proliferative effect of unopposed oestrogens is time-dependant, especially for high oestrogen doses, c. continuous combined therapy over long duration is more protective that sequential therapy in the prevention of endometrial hyperplasia or carcinoma.
Maltese: a. l-effett proliferattiv ta' l-estroġeni mhux opponuti fuq l-endometriju jiddependi mid-doża, b. dan l-effett proliferattiv ta' l-estroġeni mhux opponuti fuq l-endometriju jiddependi mill-ħin, speċjalment għal dożi għoljin ta' estroġenu, c. terapija kombinata kontinwa li ddum ħafna hija iktar protettiva minn terapija sekwenzjali filprevenzjoni ta' l-iperplażja jew karċinoma endometrijali.
English: • Acne
Maltese: • Akni
English: There is no evidence of beneficial effects on the risks of cardiovascular disease with HRT in the menopause.
Maltese: M'hemm ebda evidenza ta' effetti benefiċċjali fir-riskji ta' mard kardjovaskulari bl-HRT filmenopawża.
English: Following oral administration of Activelle, 17β-estradiol is absorbed from the gastrointestinal tract, undergoes a first-pass metabolism in the liver and other enteric organs, and reaches a peak plasma concentration within 5-8 hours.
Maltese: Wara t-teħid orali ta' Activelle, 17ß-estradiol jiġi assorbit mil-passaġġ gastrointestinali, jgħaddi fil-fwied u organi enteriċi oħra fejn jiġi metabolizzat għall-ewwel darba u jilħaq l-ogħla konċentrazzjoni fil-plażma fiż-żmien 5-8 sigħat.
English: 6.3 Shelf life 30 months.
Maltese: 4.6 Tqala u Treddigħ
English: Stop taking Activelle
Maltese: Ieqaf tieħu Activelle
English: It states that “for a new combination of oestrogen/progestogen (e.g. new administration scheme or new strength) or a new progestogen in a fixed combination, endometrial data are required, except for a known progestogen, with the same administration route and the same progestogen dose as in known fixed combination with oestrogen, where data on endometrial safety can be extrapolated from the fixed combination if exposure to the oestrogen is similar or lower”.
Maltese: Din il-linja gwida tgħid li “għal kombinazzjoni ta' estroġenu/proġestoġen (eż. skema ġdida ta' amministrazzjoni jew qawwa ġdida) jew proġestoġen ġdid f'kombinazzjoni fissa, hi meħtieġa dejta endometrijali, ħlief għal proġestoġen magħruf, bl-istess mod ta' amministrazzjoni u l-istess doża ta' proġestoġen bħal f'kombinazzjoni fissa magħrufa blestroġenu, fejn id-dejta fuq is-sigurtà endometrijali tista' tiġi estrapolata minn kombinazzjoni fissa jekk l-estroġenu jkun preżenti f'livelli simili jew iktar baxxi”.
English: - The endometrial safety data was extrapolated from another combination containing 1.0 mg estradiol and 0.1mg norethisterone acetate (NETA).
Maltese: - Id-dejta dwar is-sigurtà endometrijali ġiet estrapolata minn kombinazzjoni oħra li kien fiha 1.0 mg estradiol u 0.1mg norethisterone acetate (NETA).
English: INFORMATION IN BRAILLE Activelle 0.5 mg/0.1 mg
Maltese: Activelle 0.5mg/0.1mg
English: According to the European guideline, the endometrial biopsies should be classified, according to standardized criteria into the general classes of atrophic, proliferative, secretory, hyperplasia without atypia, hyperplasia with atypia, cancer and others.
Maltese: Skont il-linja gwida Ewropea, il-bijopsiji endometrijali għandhom jiġu klassifikati, skond kriterji standardizzati fi klassijiet ġenerali bħala atrofiċi, proliferattivi, sekretorji, iperplażja mingħajr atipja, iperplażja bl-atipja, kanċer u oħrajn.
English: Noviana 0,5 mg/0,1 mg tablett filmdrasjert
Maltese: Noviana 0,5 mg/0,1 mg tablett filmdrbħalajert
English: In the WHI study, the continuous combined conjugated equine oestrogen and medroxyprogesterone acetate (CEE + MPA) product used was associated with breast cancers that were slightly larger in size and more frequently had local lymph node metastases compared to placebo.
Maltese: Fl-istudju WHI, il-prodott ikkombinat ta' estroġeni ekwini kkonjugati kontinwi ma medroxyprogesterone acetate (CEE + MPA) użat ġie assoċjat ma' kanċers tas-sider li kienu kemmxejn ikbar fid-daqs u ħafna drabi kellhom metastasi lokali fil-glandola limfatika meta mqabbel mal-plaċebo.
English: Do not start taking Activelle:
Maltese: Tieħux Activelle:
English: Estradiol 0.5 mg (as hemihydrate) and norethisterone acetate 0.1 mg.
Maltese: Estradiol 0.5 mg (bħala hemihydrate) u norethisterone acetate 0.1 mg.
English: From a clinical study there is some evidence for an increased risk of dementia among women older than 65 years, who started using another type of oestrogen/progestagen combination than the one in Activelle.
Maltese: Minn studju kliniku hemm xi ftit eveidenza ta' żieda fir-riskju ta' demenzja fost in-nisa li għandhom iżjed minn 65 sena, li bdew jużaw tip ieħor ta' kombinazzjoni ta' estroġenu/proġestoġen minn dak ta' Activelle.
English: • Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
Maltese: • Tumuri malinni magħrufa jew suspettati, dipendenti fuq estroġenu (eż. kanċer ta' l endometriju)
English: As in all postoperative patients, scrupulous attention should be given to prophylactic measures to prevent VTE following surgery.
Maltese: Bħal fil-pazjenti kollha wara operazzjoni, għandha tingħata attenzjoni metikoluża għall-miżuri profilattiċi sabiex tiġi evitata l-VTE wara kirurġija.
English: • Liver disorders (e.g. liver adenoma)
Maltese: • Mard tal-fwied (eż. adenoma fil-fwied)
English: In a systematic review of 30 randomized controlled trials, unopposed moderate or high dose oestrogen therapy, when compared to placebo, was associated with a significant increase in rates of endometrial hyperplasia with increasing rates at longer duration of treatment (Lethaby et al. Cochrane database of systematic reviews 2004;3).
Maltese: Fl-analiżi sistematika ta' 30 prova randomizzata kkontrollata, it-terapija b'doża moderata jew għolja mhux opponuta ta' estroġenu kienet assoċjata ma' żidiet sinnifikanti fir-rati ta' iperplażja endometrijali bir-rati jiżdiedu meta t-trattament dam iktar (Lethaby et al. Cochrane database of systematic reviews 2004; 3). F'din l-analiżi, iż-żieda ta' proġestoġen bħala terapija kontinwa kienet iktar effettiva mit-terapija sekwenzjali fit-tnaqqis tar-riskju ta' l-iperplażja enodmetrijali aktar ma jdum it-trattament.
English: If pregnancy occurs during medication with Activelle, treatment should be withdrawn immediately.
Maltese: Jekk tiżviluppa l-VTE wara li tinbeda t-terapija, il-mediċina għandha titwaqqaf.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI, ID-DETENTURI TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: Spain - Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película Sweden - Activelle 0,5 mg/0,1 mg filmdragerade tabletter United Kingdom - Noviana film-coated tablets
Maltese: Spanja - Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película L-Isvezja - Activelle 0,5 mg/0,1 mg filmdragerade tabletter Ir-Renju Unit - Noviana film-coated tablets [Ara Anness I - Biex timtela mill-pajjiż partikolari] Dan il-fuljett kien approvat l-aħħar f'
English: For non-users it is estimated that the number of cases of VTE that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 8 per 1000 women aged between 60-69 years.
Maltese: Għal min ma użax HRT huwa stmat lin-numru ta' każi ta' VTE li jseħħu fuq perjodu ta' 5 snin huwa ta' madwar 3 f'kull 1000 mara bejn 50-59 sena u 8 f'kull 1000 mara bejn 60-69 sena.
English: It is estimated that in healthy women who use HRT for 5 years, the number of additional cases of VTE over a 5 year period will be between 2 and 6 (best estimate =4) per 1000 women aged 50-59 years and between 5 and 15 (best estimate =9) per 1000 women aged 60-69 years.
Maltese: Huwa stmat li f'nisa b'saħħithom li jużaw HRT għal 5 snin, in-numru ta' każi addizzjonali ta' VTE fuq perjodu ta' 5 snin ikun bejn 2 u 6 (l-aħjar stima =4) f'kull 1000 mara bejn 50-59 sena u bejn 5 u 15 (l-aħjar stima =9) f'kull 1000 mara bejn 60-69 sena.
English: Moreover, one endometrial sample from a woman who received the E2 1 mg/NETA 0.1 mg combination was evaluated as “disordered proliferative” state.
Maltese: Madankollu, kampjun endometrijali minn mara li kienet ingħatat kombinazzjoni ta' E2 1 mg/NETA 0.1 mg ġie evalwat bħala fi stat “proliferattiv diżordnat”.
English: Pack sizes:
Maltese: Sewqan u tħaddim ta' magni:
English: Free T4 and free T3 concentrations are unaltered.
Maltese: Konċentrazzjonijiet ta' T4 ħieles u T3 ħieles jibqgħu mhux mibdulin.
English: a. Dose-dependency of the proliferative effect of unopposed oestrogens
Maltese: Id-dipendenza fuq id-doża ta' l-effett proliferattiv ta' l-estroġeni mhux opponuti
English: • Probable dementia (For further information, see section 4.4)
Maltese: • Dimenzja probabbli (Għal aktar tagħrif, ara sezzjoni 4.4)
English: Animal studies have shown embryo-lethal effects of estradiol or estradiol valerate even at relatively low doses; malformations of the urogenital tract and feminization of male fetuses were observed.
Maltese: Studji fuq l-annimali wrew li anki f'dożi relattivament baxxi estradiol u estradiol valerate kellhom effetti letali fuq l-embriju; kienu osservati malformazzjonijiet fil-passaġġ uroġenitali u feminizzazzjoni ta' feti maskili.
English: • If you have systemic lupus erythematosus (SLE, autoimmune collagen disease, which may affect many organ systems)
Maltese: • Jekk għandek lupus erythematosus sistemika (SLE, marda tal-kollaġini awtoimmunitarja li tista' taffettwa ħafna sistemi ta' organi)
English: Estonia - Activelle low 0,5 mg/0,1 mg õhukese polümeerikattega tablett Finland - Activelle 0,5 mg/0,1 mg tabl.
Maltese: Ir-Repubblika Ċeka - Noviana potahované tablety Id-Danimarka - Activelle low filmovertrukne tabletter L-Estonja - Activelle low 0,5 mg/0,1 mg õhukese polümeerikattega tablett Il-Finlandja - Activelle 0,5 mg/0,1 mg tabl.
English: It should be noted that sample size was very small (22 to 29 women), and no 95% confidence intervals for the incidence of hyperplasia are stated.
Maltese: Għandu jiġi nnutat li d-daqs tal-kampjun kien żgħir (bejn 22 u 29 mara), u ma ssemmew l-ebda intervalli ta' kunfidenza ta' 95% għall-inċidenza ta' l-iperplażja.
English: Iceland - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Ireland - Activelle low 0.5mg/0.1mg film-coated tablets Italy - Activelle® 0,5 mg/0,1 mg compresse film-rivestite Latvia - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Lithuania - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Luxembourg - Activelle minor comprimés pelliculés The Netherlands - Activelle filmomhulde tabletten Norway - Noviana 0,5 mg/0,1 mg tablett filmdrasjert Portugal - 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película Romania - Noviana comprimate filmate
Maltese: Il-Latvja - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Il-Litwanja - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Il-Lussemburgu - Activelle minor comprimés pelliculés L-Olanda - Activelle filmomhulde tabletten
English: Both considered the endometrial safety of Activelle 0.5 mg/0.1 mg to be insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/CHMP/021/97 rev 1).
Maltese: It-tnejn li huma qiesu li s-sigurtà endometrijali ta' Activelle 0.5 mg/0.1 mg ma kinitx intweriet b'mod suffiċjenti skond il-linja gwida tas-CHMP għall-prodotti tal-HRT (EMEA/CHMP/021/97 rev 1).
English: The applicant/MAH was asked to demonstrate the endometrial safety of Activelle 0.5mg/0.1mg for the following reasons:
Maltese: L-applikant /MAH intalab juri s-sigurtà endometrijali ta' Activelle 0.5mg/0.1mg għar-raġunijiet li ġejjin:
English: Hypersensitivity, see also “Skin and subcutaneous tissue disorders
Maltese: Sensittività eċċessiva, ara wkoll "Disturbi fil-ġilda u fittessuti ta' taħt ilġilda"
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: estradiol 0.5 mg (as hemihydrate), norethisterone acetate 0.1 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha: estradiol 0.5mg (bħala hemihydrate), norethisterone acetate 0.1 mg
English: There was no evidence of a difference in risk between the different routes of administration.
Maltese: Ma kien hemm l-ebda evidenza ta' riskji differenti bejn ir-rotot differenti ta' mnejn jingħataw.
English: According to calculations from the trial data, it is estimated that:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq u l-Manifattur:
English: By Week 3, the decrease in mean number of moderate to severe hot flushes for the 0.5 mg estradiol treatment group was statistically significant (p≤0.001) when compared to the placebo group.
Maltese: Mat-3 ġimgħa t-tnaqqis fil-medja ta' numru ta' fwawwar severi għal moderati fil-grupp taħt kura b'0.5 mg estradiol kien statistikament sinifikanti meta mqabbel mal-grupp tal-plaċebo.
English: For other HRT products there are only limited data from trials examining the effects on the risk of cardiovascular disease.
Maltese: Għal prodotti ta' HRT oħra hemm biss dejta limitata minn studji li eżaminaw l-effetti fuq ir-riskju ta' mard kardjovaskulari.
English: Stroke
Maltese: Bagsværd
English: • Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users (For further information, see sections 4.3 and 4.4)
Maltese: • Trombo-emboliżmu tal-vini, jiġifieri trombożi fil-vini fondi tas-sieq jew tal-pelvi u emboliżmu pulmonari, huwa aktar frekwenti f'dawk li jużaw it-terapija ormonali sostitwita milli f'dawk li ma jużawhx (Għal aktar tagħrif, ara sezzjonijiet 4.3 u 4.4)
English: There was no significant difference in the rate of endometrial hyperplasia of continuous oestrogenprogestogen combinations in comparison with placebo after 12 and 24 months.
Maltese: Ma kienx hemm differenza sinnifikanti fir-rata ta' iperplażja endometrijali ta' kombinazzjonijiet kontinwi ta' estroġenu-proġestoġen meta mqabbla malplaċebo wara 12 u 24 xahar.
English: Endometrial thickening
Maltese: Kanċer ta' l-endometriju
English: - the addition of a progestogen for 12 days of a monthly treatment cycle is considered sufficient to protect the endometrium from an excess risk of hyperplasia (and ultimately endometrial cancer), and even longer periods, and a continuous combination will confer increasing protective effects.
Maltese: - iż-żieda ta' proġestoġen għal 12-il jum f'ċiklu ta' trattament ta' kull xahar hi meqjusa suffiċjenti biex tipproteġi l-endometriju minn riskju eċċessiv ta' iperplażja (u finalment kanċer endometrijali), u anke perjodi itwal, u kombinazzjoni kontinwa twassal għal iktar effetti protettivi.
English: Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I - To be completed nationally] Estradiol/norethisterone acetate
Maltese: Activelle u ismijiet assoċjati miegħu (ara Anness I) 0.5 mg/0.1 mg pilloli miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Estradiol/norethisterone
English: Novo Nordisk Pharma GmbH
Maltese: Novo Nordisk Pharma GmbH Opernring 3-5 A-1010
English: • Swelling of arms and legs (peripheral oedema)
Maltese: • nefħa fl-idejn jew fis-saqajn (edima periferali)
English: For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years.
Maltese: Għal nisa li ma jużawx HRT, huwa stmat lin-numru ta' każi ta' puplesija li jseħħu fuq perjodu ta' 5 snin huwa ta' madwar 3 f'kull 1000 mara bejn 50-59 sena u 11 f'kull 1000 mara bejn 60-69 sena.
English: It is estimated that for women who use conjugated oestrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate = 1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years.
Maltese: Huwa stmat li f'nisa li jużaw estroġeni kkonjugati u MPA għal 5 snin, innumru ta' każi addizzjonali jkun bejn 0 u 3 (l-aħjar stima =1) f'kull 1000 mara bejn 50-59 sena u bejn 1 u 9 (l-aħjar stima =4) f'kull 1000 mara bejn 60-69 sena.
English: In conclusion, the CHMP agreed that the proliferative effect of unopposed oestrogens on endometrium is dependent on the dose of oestrogens.
Maltese: Bħala konklużjoni, is-CHMP qabel li l-effetti proliferattivi ta' l-estroġeni mhux opponuti fuq lendometriju huma dipendenti mid-doża ta' l-estroġeni.
English: Medical check-ups
Maltese: Uġigħ addominali
English: Activelle is a continuous combined hormone replacement therapy intended for use in women with an intact uterus.
Maltese: Activelle huwa terapija ormonali sostitwita, ikkombinata u kontinwa maħsub għall-użu f'nisa blutru intatt.
English: Activelle is a continuous combined HRT product containing 17β-estradiol and norethisterone acetate with the intent of avoiding the regular withdrawal bleeding associated with cyclic or sequential HRT.
Maltese: Activelle huwa prodott ta' l-HRT kombinat u kontiwu li fih 17ß-estradiol u norethisterone acetate bl-għan li jiġi evitat id-dmija regolari ta' rtirar assoċjat ma' l-HRT ċiklikali u sekwenzjali.
English: A randomised placebo-controlled trial, the Women's Health Initiative study (WHI), and epidemiological studies, including the Million Women Study (MWS), have reported an increased risk of breast cancer in women taking oestrogens, oestrogen-progestagen combinations or tibolone for HRT for several years (see section 4.8).
Maltese: Prova klinika tat-tip randomised ikkontrollata bil-plaċebo, l-Inizjattiva għal-Saħħet in-Nisa (WHI), u studji epidemjoloġiċi, fosthom l-Istudju ta' Miljun Mara (MWS), irrapportaw żieda ta' kanċer tas-sider f'nisa li jieħdu estroġeni, kombinazzjonijiet ta' estroġeni-proġestoġeni jew tibolone għall- HRT għal ħafna snin (ara sezzjoni 4.8).
English: Long-term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies.
Maltese: L-użu fit-tul (mill-inqas 5-10 snin) ta' prodotti tal-HRT b' estroġenu biss f'nisa li kellhom isterektomija ġie assoċjat ma' żieda fir-riskju ta' kanċer ta' l-ovarji f'xi studji epidemjoloġiċi.
English: OTHER
Maltese: MEMBRI
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Maltese: Proteini li jeħlu oħra jistgħu jkunu elevati fis-serum, jiġifieri l-globulina li teħel mal-kortikojde (CBG), il-globulina li teħel ma' l-ormon tas-sess (SHBG) li twassal għal żieda ta' kortikosterojdi u sterojdi tas-sess fiċċirkulazzjoni, rispettivament.
English: It is a lower strength with a lower oestrogen/progestogen ratio than the currently approved Activelle, which contains 1 mg E2 and 0.5 mg NETA.
Maltese: Huwa inqas qawwi b'bilanċ ta' l-estroġenu/proġestoġen iktar baxx mill-prodott Activelle li huwa attwalment approvat u li fih 1 mg E2 u 0.5 mg NETA.
English: PHARMACOLOGICAL PROPERTIES
Maltese: Għamla Farmaċewtika
English: Opernring 3-5
Maltese: Tagħmlux fil-friġġ.
English: Gall bladder disease Gall bladder disease has been reported after treatment with oestrogen/progestagen.
Maltese: Mard fil-bużżieqa tal-marrara Ġie rrappurtat mard fil-bużżieqa tal-marrara wara kura b'estroġenu/proġestaġen.
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Maltese: L-assorbiment tar-reżina T3 jitnaqqas, u dan jirrifletti livell elevat ta' TBG.
English: • High blood pressure
Maltese: • Pressjoni għolja
English: • Heartburn (dyspepsia)
Maltese: • Ħruq ta' stonku (dispepsja)
English: Endometrial hyperplasia
Maltese: Iperplejżja ta' l-endometriju
English: For oestrogen plus progestagen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with oestrogens alone.
Maltese: Għall-HRT ikkombinat minn estroġenu flimkien ma' proġestoġenu, diversi studji epidemjoloġiċi rrapportaw riskju globali akbar għall-kanċer tas-sider milli b'estroġenu biss.
English: It undergoes first-pass metabolism in the liver and other enteric organs, and reaches a peak plasma concentration of approximately 2.4 ng/ml CV 41 % (after administration of two Activelle tablets) within 0.5 -1.5 hour.
Maltese: Jgħaddi fil-fwied u f'organi enteriċi oħra fejn jiġi metabolizzat għallewwel darba u jilħaq konċentrazzjoni massima fil-plażma ta' madwar 2.4 ng/ml CV 41 % (wara t-teħid ta' żewġ pilloli ta' Activelle) fi żmien 0.5-1.5 sigħat.
English: • Dizziness
Maltese: TAL-PRODOTT
English: Take special care with Activelle
Maltese: U EVALWAZZJONI XJENTIFIKA TA' ACTIVELLE
English: Headache
Maltese: Lott
English: In this study, the upper limit of the two-sided 95% CI of the incidence of endometrial hyperplasia was higher than the upper limit of 2%, and is therefore not considered acceptable.
Maltese: F'dan l-istudju, il-limitu ta' fuq ta' CI ta' 95% b'żewġ naħat ta' l-inċidenza ta' l-iperplażja endometrijali kien ikbar mil-limitu massimu ta' 2%, u għalhekk mhuwiex meqjus aċċettabbli.
English: - For the calculation of the incidence rate of endometrial hyperplasia and the two-sided 95 % confidence interval, in case of insufficient tissue obtained by biopsy and endometrial thickness ≥ 5 mm, the biopsy should be repeated or patient excluded from the calculation.
Maltese: - Għall-kalkolu tar-rata ta' l-inċidenza ta' l-iperplażja endometrijali u l-intervall ta' konfidenza ta' 95 % b'żewġ naħat, jekk minn bijopsija jinkiseb ammont insuffiċjenti ta' tessut jew ikun hemm ħxuna endometrijali ≥ 5 mm, il-bijopsija għandha terġa' ssir jew inkella l-pazjent jitneħħa mill-kalkolu.
English: Like other progestogens norethisterone causes virilization of female fetuses in rats and monkeys.
Maltese: Bħal proġestoġeni oħra, norethisterone jikkawża virilizzazzjoni ta' feti femminili fil-firien u fixxadini.
English: According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT about 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65.
Maltese: Skond tagħrif minn studji epidemjoloġiċi, laħjar stima tar-riskju huwa li f'nisa li ma jużawx l-HRT madwar 5 f'kull 1000 huma mistenija li jiġu ddijanjostikati b'kanċer ta' l-endometriju bejn l-etajiet ta' 50 u 65 sena.
English: HRT, especially oestrogen-progestagen combined treatment, may increase the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Maltese: L-HRT, speċjalment il-kura kkombinata b' estroġenu-proġestoġenu, tista' żżid id-densità tarritratti mammografiċi li jistgħu jaffettwaw b'mod negattiv l-osservazzjoni radjoloġika tal-kanċer tas-sider.
English: The following side effects have been reported after taking medicines containing oestrogen/progestagens.
Maltese: L-effetti sekondarji li ġejjien ġew irrapportati wara li ttieħdu mediċini li fihom estroġenu/prgestoġeni.
English: Bleeding and/or spotting appeared in 11 to 15% of the women during the first six months of treatment.
Maltese: Matul l-ewwel sitt xhur ta' kura 11 sa 15% tan-nisa kellhom dmija jew taqtir.
English: Medical examination/follow-up
Maltese: TAL-PRODOTT MEDIĊINALI
English: Dyspepsia
Maltese: FARMAĊEWTIKU