FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaginitis including infection of the genitals caused by a fungus, changes in sexual drive, mood disturbances, dizziness, headache, migraine, anxiety, intolerance to contact lenses, blood clots in a vein (thrombosis), nausea, bloating, abdominal pain, hirsutism, pruritus, rash, oedema
Maltese: Vaġinite inkluż infezzjoni tal-ġenitali ikkawżata minn fungu, bidliet fil-ġibda sesswali, disturbi fil-burdata, sturdament, uġigħ ta' ras, emigranja, ansjetà, intolleranza għal lentijiet tal-kuntatt, emboli tad-demm f'vina (trombożi), nawżja, nefħa, uġigħ addominali, irsutiżmu (żieda fix-xagħar), prurite, raxx, edema
English: − You should only use [invented name] under medical supervision.
Maltese: − Għandek tuża [isem ivvintat] biss taħt superviżjoni medika.
English: The following adverse reactions have been associated with oral and/or transdermal oestrogen therapy (class effects):
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew assoċjati ma' terapija tal-estroġeni orali u/jew transdermali (effetti tal-klassi):
English: 1 to 10 patients treated out of 10,000
Maltese: 1 sa 10 pazjenti kkurati minn kull 10,000
English: The geometric mean half-life of E2 was 5.05 hours, with high interindividual variability.
Maltese: Il-half-life medja ġeometrika ta' E2 kienet 5.05 sigħat, b'varjabbiltà interindividwali għolja.
English: Oestrogens maintain vaginal pH around normal range (4.5) which enhances normal bacterial flora.
Maltese: L-estroġeni jżommi l-pH vaġinali madwar firxa normali (4.5), u dan itejjeb il-flora batterika normali.
English: - Asthma - Epilepsy - Diabetes - Gallstones - High blood pressure - Migraines or severe headaches - A liver disorder, such as a benign liver tumour
Maltese: - Epilessija - Diabete - Ġebel fil-marrara - Pressjoni tad-demm għolja
English: After stopping treatment risk remain elevated for at least 10 years.
Maltese: Wara li titwaqqaf il-kura, ir-riskju jibqa' wieħed għoli għal tal-anqas 10 snin.
English: - breast cancer - endometrial hyperplasia and carcinoma - ovarian cancer - blood clots in the veins of the legs of lungs (venous thromboembolism) - heart disease - stroke - probable memory loss if Hormone Replacement Therapy is started over the age of 65
Maltese: - emboli tad-demm fil-vini tas-saqajn tal-pulmuni (tromboemboliżmu fil-vini) - mard tal-qalb - puplesija - telf probabbli tal-memorja jekk tinbeda Terapija ta' Sostituzzjoni tal-Ormoni f'età ta' aktar minn 65 sena
English: The experience treating women older than 65 years is limited.
Maltese: L-esperjenza fil-kura ta' nisa anzjani li għandhom aktar minn 65 sena hija limitata.
English: - Otosclerosis
Maltese: - Ażżma - Otosklerożi
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskuloskeletali, ittessut konnettiv u l għadam
English: Therapeutic indications (areas of use):
Maltese: Indikazzjonijiet terapewtiċi (żoni ta' użu):
English: Endogenous 17β-estradiol induces and maintains the primary and secondary female sexual characteristics.
Maltese: 17β-estradiol endoġenu jinduċi u jżomm il-karatteristiċi sesswali primarji u sekondarji talmara.
English: [invented name] is a cream for vaginal use.
Maltese: [isem ivvintat] huwa krema għall-użu vaġinali.
English: # Overal risk ratio.
Maltese: Proporzjon ta' riskju ġenerali.
English: Section 4.1 - Therapeutic indications
Maltese: Sezzjoni 4.1 Indikazzjonijiet terapewtiċi
English: Reproductive system and breast disorders
Maltese: Disturbi fis-sistema riproduttiva u ssider
English: HRT does not improve cognitive function.
Maltese: L-HRT ma ttejjibx il-funzjoni konjittiva.
English: Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis)
Maltese: L-alkoħol cetyl stearyl jista' jikkawża irritazzjoni lokali fil-ġilda (eż. dermatite ta' kuntatt)
English: As its active substance, [invented name] contains 17ß-estradiol, a natural sex hormone, at a concentration of 0.01%.
Maltese: Bħala s-sustanzi attiva tiegħu, [isem ivvintat] fih 17ß-estradiol, ormon tas-sess naturali, f'konċentrazzjoni ta' 0.01%.
English: In medical terms this is known as ‘vaginal atrophy'.
Maltese: F'termini mediċi, dan huwa magħruf bħala ‘atrofija vaġinali'.
English: Do not use [invented name] if - You are allergic (hypersensitive) to estradiol or any of the other ingredients of [invented name] (listed in Section 6 Further information) - You have or have ever had breast cancer, or you are suspected of having it - You have or have ever had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or you are suspected of having it - You have any unexplained vaginal bleeding - You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated - You have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) - You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) - You have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina - You have or have ever had a liver disease and your liver function tests have not returned to normal - You have a rare blood problem called “porphyria”, which is passed down in families (inherited).
Maltese: - Għandek jew qatt kellek kanċer tas-sider, jew għandek suspett li għandek - Għandek jew qatt kellek kanċer li huwa sensittiv għall-estroġeni, bħal kanċer fit-tessut li jiksi l-ġuf (endometriju), jew għandek suspett li għandek - Għandek xi fsada vaġinali inspjegabbli - Għandek tħaxxin eċċessiv tat-tessut li jiksi l-ġuf (iperplażja endometrijali) li mhuwiex jiġi kkurat - Għandek jew qatt kellek embolu tad-demm f'vina (trombożi), bħal fir-riġlejn (trombożi fil-vini fil-fond) jew fil-pulmuni (emboliżmu pulmonari) - Għandek disturb fit-tagħqid tad-demm (bħal nuqqas ta' proteina C, proteina S, jew antithrombin)
English: 1 to 10 patients treated out of 100
Maltese: 1 sa 10 pazjenti kkurati minn kull 100
English: [invented name] is a cream containing estradiol for vaginal use.
Maltese: [isem ivvintat] huwa krema li fiha estradiol għall-użu vaġinali.
English: Oral oestrogen only* Oral combined oestrogen-progestogen
Maltese: Estroġenu orali biss* Estroġenu u proġestoġenu orali flimkien
English: Estradiol conversion to estriol is irreversible.
Maltese: Il-konverżjoni ta' Estradiol għal estriol hija irriversibbli.
English: HRT is associated with a 1.3-3 fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Maltese: L-HRT hija assoċjata ma' 1.3-3 darbiet żieda fir-riskju relattiv li jiġi żviluppat tromboemboliżmu fil-vini (VTE), jiġifieri trombożi fil-vini fil-fond jew emboliżmu pulmonari.
English: Part A. - 0.01% w/w estradiol containing medicinal products for topical use(as per Annex I)
Maltese: Parti A. - prodotti mediċinai li fihom 0.01% w/w estradiol għal użu topiku
English: [invented name] should be applied with an applicator.
Maltese: [isem ivvintat] għandu jiġi applikat b'applikatur.
English: Estradiol is the most potent natural oestrogen to act intracellularly.
Maltese: Estradiol huwa l-estroġenu naturali l-aktar qawwi b'azzjoni fiċċelloli.
English: If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe' (e.g. antithrombin, protein S, or protein C deficiencies or a combination of defects) HRT is contraindicated.
Maltese: Jekk jiġi identifikat nuqqas trombofiliku li jifred bi trombożi fil-membri tal-familja jew jekk in-nuqqas huwa ‘sever' (eż. nuqqas ta' antithrombin, proteina S, jew proteina C jew kombinazzjoni ta' nuqqasijiet) l-HRT hija kontraindikata.
English: The relative risk does not change with age or time since menopause.
Maltese: Ir-riskju relattiv ma jinbidilx mal-età jew iż żmien mill-menopawża.
English: Unopposed oestrogen stimulation may lead to premalignant transformation in the residual foci of endometriosis.
Maltese: Stimulazzjoni tal-estroġenu mhux opposta tista' twassal għal trasformazzjoni premalinna filfoki residwi ta' endometrijożi.
English: In another study, mean estradiol serum concentrations at baseline and at day 31 (i.e. about 36 h after administration of study medication on day 29) were 6.4 pg/ml and 15.1 pg/ml, respectively, in the [invented name] group and 4.4 pg/ml and 6.2 pg/ml, respectively, in the placebo group.
Maltese: 1 pg/ml, rispettivament, fil-grupp ta' [isem ivvintat] u 4.4 pg/ml and 6.2 pg/ml, rispettivament, fil-grupp ta' plaċebo.
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 radio-immunoassay) or T3 levels (by radio-immunoassay).
Maltese: L-estroġeni jżidu globulina li teħel mat-tirojde (TBG), li jwasslu għal żieda fiċ-ċirkolazzjoni tal-ormon totali tat-tirojde (kif imkejjel bil-jodju li jeħel mal-proteini (PBI)), il-livelli T4 (permezz tal-immunoanaliżi tal-kolonna jew tar-radju) jew livelli
English: Additional cases per 1000 users
Maltese: Każijiet addizzjonali għal kull 1000
English: HRT and cancer
Maltese: HRT u kanċer
English: The risk of getting stroke is about 1.5 times higher in HRT users than in non-users.
Maltese: Ir-riskju li jkollok puplesija huwa madwar 1.5 ogħla f'utenti tal-HRT milli f'dawk li mhumiex utenti.
English: Risk of coronary artery disease
Maltese: Riskju ta' marda fl-arterja koronarja
English: HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Maltese: HRT hija assoċjata ma' 1.3-3 darbiet ir-riskju li jiġi żviluppat tromboemboliżmu fil-vini (VTE), jiġifieri trombożi fil-vini fil-fond jew emboliżmu pulmonari.
English: CEE oestrogen-only CEE+MPA oestrogen & progestogen
Maltese: Estroġenu biss CEE Estroġenu u proġestoġenu CEE+MPA $
English: Ovarian cancer is rare.
Maltese: Il-kanċer tal-ovarji huwa rari.
English: - Hypertension
Maltese: - Ipertensjoni
English: During prolonged use, vigilance is required for possible systemic effects.
Maltese: Hija meħtieġa viġilanza għal effetti sistemiċi possibbli.
English: For more information about these side effects, see Section 2
Maltese: Għal aktar informazzjoni dwar dawn l-effetti sekondarji, ara Sezzjoni 2
English: Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).
Maltese: L-alkoħol cetyl stearyl jista' jikkawża irritazzjoni lokali fil-ġilda eż. dermatite ta' kuntatt).
English: For women aged 50 to 79 who are taking oestrogenprogestagen HRT over 5 years, there will be 13 to 20 cases in 1000 users (i.e. an extra 4 to 6 cases).
Maltese: Għal nisa li għandhom bejn 50 sa 79 sena li qegħdin jieħdu HRT b'estroġenu u proġestoġenu fuq perjodu ta' 5 snin, se jkun hemm 13sa 20 każ f'1000 utent (jiġifieri 4 sa 6 każijiet żejda).
English: The risk of coronary artery disease is slightly increased in users of combined oestrogenprogestogen HRT over the age of 60 (see section 4.4).
Maltese: Ir-riskju ta' marda fl-arterja koronarja huwa kemxejn akbar f'utenti ta' HRT b'estroġenu u proġestoġenu flimkien li għandhom aktar minn 60 sena (ara sezzjoni 4.4).
English: Stroke
Maltese: EFFETTI
English: Nonclinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SmPC.
Maltese: L-istudji mhux kliniċi ma jipprovdu ebda data addizzjonali tar-rilevanza għas-sigurtà klinika aktar minn dik diġà inkluża f'sezzjonijiet oħra tal-SmPC.
English: Therapy with [invented name] should only be administered together with clinical monitoring.
Maltese: It-terapija b'[isem ivvintat] għandha tingħata biss flimkien ma' monitoraġġ kliniku.
English: Transient, mild local irritation (e.g. pruritus, burning).
Maltese: Irritazzjoni temporanja, ħafifa u lokali (eż. ħakk, ħruq).
English: Medical examination/follow-up
Maltese: Eżaminazzjoni medika/segwitu
English: Interactions of [invented name] with other medicinal products were not investigated.
Maltese: L-interazzjonijiet ta' [isem ivvintat] ma' prodotti mediċinali oħra ma kinux investigati.
English: - known hypersensitivity to oestradiol, prednisolone, cetyl stearyl alcohol or to any of the excipients of [invented name] .
Maltese: − jekk taf li inti allerġiku (ipersensittiv) għal oestradiol, prednisolone, cetyl stearyl alcohol jew għal xi waħda mis-sustanzi l-oħra ta' [isem ivvintat]
English: Very rare (< 1/10,000),
Maltese: Rari ħafna (<1/10,000),
English: For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. 5 extra cases) For women in their 50s who have had their womb removed and have been taking oestrogenonly HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).
Maltese: Għal nisa li jinsabu fil-ħamsijiet li għandhom l-utru mneħħi u li ilhom jieħdu HRT b'estroġenu biss għal aktar minn 5 snin, se jkun hemm 5 sa 8 każijiet f'1000 utent (jiġifieri każ żejjed).
English: Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
Maltese: In-nisa li huma diġà fuq kura kronika antikoagulanti jeħtieġu konsiderazzjoni bir-reqqa talbenefiċċju-riskju tal-użu ta' HRT.
English: - A history of endometrial hyperplasia (see below)
Maltese: - Storja ta' iperplażja endometrijali (ara hawn taħt)
English: - It belongs to a group of hormones called oestrogens.
Maltese: - Dan jagħmel parti minn grupp ta' ormoni msejħa estroġeni.
English: Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis.
Maltese: Stimulazzjoni tal-estroġenu mhux opposta tista' twassal għal trasformazzjoni premalinna jew malinna fil-foċi residwi ta' endometrijożi.
English: Uncommon:
Maltese: WHI:
English: - Risk factors for thromboembolic disorders (see below)
Maltese: - Il-fatturi tar-riskju għad-disturbi tromboemboliċi (ara hawn taħt)
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sexhormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Maltese: Proteini ta' twaħħil oħra jistgħu jkunu għoljin fis-serum, jiġifieri globulina li teħel mal-kortikojde (CBG), globulina li teħel mal-ormoni tas-sess (SHBG) li jwasslu għal żieda fil-kortikosterojdi li jiċċirkolaw u sterojdi tas-sess, rispettivament.
English: Section 5.3 Preclinical safety data
Maltese: Sezzjoni 5.3 Data ta' qabel l-użu kliniku dwar is-sigurtà
English: Reasons for immediate withdrawal of therapy
Maltese: Raġunijiet għall-irtirar immedjat tat-terapija
English: For more information, see ‘Blood clots in a vein (thrombosis)'.
Maltese: Għal aktar informazzjoni, ara ‘Emboli tad-demm f'vina (trombożi)'.
English: For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
Maltese: Għal nisa li ilhom jieħdu HRT għal 5 snin, se jkun hemm bejn 2 u 3 każijiet f'kull 1000 utent (jiġifieri sa każ wieħed żejjed).
English: If symptoms persist beyond 4 weeks, alternative therapies should be considered.
Maltese: Jekk is-sintomi jippersistu għal aktar minn 4 ġimgħat, għandhom jiġu kkunsidrati terapiji alternattivi.
English: - Probable dementia over the age of 65 (see section 4.4)
Maltese: antitrombina, ara sezzjoni 4.4)
English: - Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Maltese: - Huma ppreżentati r-riżultati tal-akbar prova b'mod każwali kkontrollata bi plaċebo (studju WHI) u l-akbar studju epidemjoloġiku.
English: At around ≥ 0.01% topically or systemically, estradiol widens the capillary vessels and promotes general blood perfusion.
Maltese: F'madwar ≥ 0.01% topikament jew sistemikament, estradiol iwessa' l-arterji u l-vini kapillari u jippromwovi l-perfużjoni ġenerali tad-demm.
English: Compare
Maltese: ansjetà
English: Similarly to other steroid hormones, estradiol acts directly on genetic information (DNA) via specific receptors following systemic administration.
Maltese: B'mod simili għal ormoni tal-isterojdi oħrajn, estradiol jaġixxi direttament fuq linformazzjoni ġenetika (DNA) permezz ta' riċetturi speċifiċi wara għoti sistemiku.
English: Cream [invented name] is used in women for the treatment of atrophic vulva disorders attributable to oestrogen deficiency and for Lichen sclerosus (long-term itchy skin signs) on external genitals.
Maltese: Krema [isem ivvintat] jintuża fin-nisa għall-kura ta' disturbi fil-vulva atrofika attribwibbli għan-nuqqas ta' estroġenu u għal Lichen sclerosus (sinjali ta' ħakk fil-ġilda fit-tul) fuq ġenitali esterni.
English: Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk.
Maltese: Il-pazjenti bi stati trombofiliċi magħrufa għandhom aktar riskju ta' VTE u l-HRT tista' żżid dan ir-riskju.
English: The maximum duration of treatment is 4 weeks.
Maltese: Il-perjodu massimu ta' kura huwa 4 ġimgħat.
English: − when using [invented name] at the same time as latex products (e.g. condoms, diaphragms).
Maltese: − meta tuża [isem ivvintat] fl-istess ħin ta' prodotti tal-latex (eż. kondoms, dijaframmi).
English: WHI Studies - Additional risk of VTE over 5 years' use Age range (years) Incidence per 1000 women placebo arm over 5 years
Maltese: WHI flimkien - Riskju addizzjonali ta' puplesija iskemika* fuq perjodu ta' użu ta' 5 snin Medda ta' età (snin)
English: Million Women Study - Estimated additional risk of breast cancer after 5 years' use Age range (years) Additional cases per 1000 users of HRT over 5 year period*
Maltese: Studju ta' Miljun Mara - Riskju addizzjonali stmat ta' kanċer tas-sider wara użu ta' 5 snin
English: If unexpected genital bleeding occurs, treatment should be discontinued, the reason should be investigated which may include vaginal ultrasound investigation and endometrial biopsy to exclude endometrial hyperplasia or malignancy.
Maltese: Jekk isseħħ fsada ġenitali mhux mistennija, il-kura għandha titwaqqaf, ir-raġuni għandha tiġi investigata, li tista' tinkludi investigazzjoni vaġinali b'ultrasound u bijopsija tal-endometriju biex jiġi eskluż tumur malinn jew iperplażja endometrijali.
English: Incidence per 1000 women placebo arm over 5 years
Maltese: 1000 mara fergħa tal-plaċebo fuq 5 snin
English: WHI studies combined - Additional risk of ischaemic stroke* over 5 years' use
Maltese: Studji WHI - Riskju addizzjonali ta' VTE matul użu ta' 5 snin
English: Combined oestrogen-progestogen
Maltese: Estroġenu u proġestoġenu flimkien
English: If prolonged immobilisation is to follow elective surgery, temporarily stopping HRT 4 to 6 weeks earlier is recommended.
Maltese: Jekk kirurġija elettiva tkun sejra tiġi segwita minn immobilizzazzjoni fit-tul, huwa rakkomandat li l-HRT titwaqqaf temporanjament minn 4 sa
English: US WHI studies - additional risk of breast cancer after 5 years' use Age range (years)
Maltese: WHI tal-Istati Uniti - riskju addizzjonali ta' kanċer tas-sider wara użu ta' 5 snin
English: The risk ratio is not constant but will increase with increasing duration of use
Maltese: Il-proporzjon ta' riskju mhuwiex konsistenti iżda se jiżdied b'żieda fil-perjodu ta' użu
English: In addition, estradiol also has rapid, nongenomic effects (signal transduction).
Maltese: Barra minn hekk, estradiol għandu effetti rapidi mhux ġenomiċi (transduzzjoni tas-sinjali).
English: Changes in libido, mood disturbances
Maltese: Bidliet fil-libido, disturbi fil-burdati
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Maltese: Matul il-kura, huma rrakkomandati visti mediċi perjodiċi ta' frekwenza u natura adatti għall-mara individwali.
English: Women aged 50 to 79 who are not taking HRT, on average, 9 to 14 in 1000 will be diagnosed with breast cancer over a 5-year period.
Maltese: In-nisa li għandhom bejn 50 u 79 sena li mhumiex qegħdin jieħdu HRT, bħala medja, 9 sa 14 minn kull 1000 se jiġu dijanjostikati b'kanċer tas-sider fuq perjodu ta' 5 snin.
English: Some studies including the WHI trial suggest that the long-term use of combined HRTs may confer a similar or slightly smaller risk (see Section 4.8).
Maltese: Xi studji jinkludu prova WHI li tissuġġerixxi li l-użu fit-tul ta' HRTs flimkien tista' tikkonferixxi riskju simili jew ftit iżgħar (ara Sezzjoni 4.8).
English: Hypersensitivity skin reaction (allergic contact eczema)
Maltese: - Marda tromboembolika arterjali attiva jew reċenti (eż. anġina, infart mijokardijaku)
English: - Skin and subcutaneous disorders: erythema multiforme, erythema nodosum, vascular purpura
Maltese: - Disturbi fil-ġilda u taħt il-ġilda: eritema multiforme, eritema nodosum, purpura vaskulari - Dimensja probabbli f'età akbar minn 65 sena (ara sezzjoni 4.4) - Mard tal-bużżieqa tal-marrara
English: Transient, mild skin irritation (e.g. burning, erythema).
Maltese: Kwalunkwe sezzjoni eżistenti għandha titħassar.]
English: HRT, especially oestrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Maltese: L-HRT, speċjalment kura ta' estroġenu u proġestoġenu flimkien, iżżid id-densità talimmaġnijiet mammografiċi li jistgħu jaffettwaw ħażin id-detezzjoni radjoloġika tal-kanċer tas-sider.
English: [invented name] is unlikely to have any effect on alertness or coordination.
Maltese: [isem ivvintat] huwa improbabbli li jkollu xi effett fuq l-attenzjoni jew il-koordinazzjoni.
English: The following categories are used to express the frequency of side effects: Very common: more than 1 in 10 patients treated Common:
Maltese: Mhux komuni: 1 sa 10 pazjenti kkurati minn kull 1,000 Rari:
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Maltese: Hemm tnaqqis fit-teħid tar-reżina T3, u dan jirrifletti t-TBG għolja.
English: Thus, estradiol affects transcription (RNA synthesis) and therefore stimulates the synthesis of specific proteins.
Maltese: Għalhekk, estradiol jaffettwa ttranskrizzjoni (sinteżi tal-RNA) u għaldaqstant jistimula s-sinteżi ta' proteini speċifiċi.
English: - The level of risk is dependent on the duration of use (see section 4.4).
Maltese: - Il-livell ta' riskju huwa dipendenti mill-perjodu ta' użu (ara sezzjoni 4.4).
English: Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Maltese: In-nisa b'ipertrigliċeridimja pre-eżistenti għandhom jiġu segwiti mill-qrib matul it-terapija ta' sostituzzjoni tal-estroġenu jew ta' sostituzzjoni tal-ormoni, peress li ġew irrapportati każijiet rari ta' żidiet kbar ta' trigliċeridi fil-plażma li wasslu għal pankreatite b'terapija blestroġenu f'din il-kundizzjoni.
English: Abnormal uterine bleeding (breakthrough bleeding/spotting), breast pain, breast tenderness, breast enlargement, breast discharge, leukorrhoea
Maltese: Fsada anormali fl-utru (fsada/tbajja li jippenetraw), uġigħ fis-sider, sensittività tas-sider, tkabbir tas-sider, tnixxija mis-sider, lewkorreja
English: frequency cannot be estimated from the available data Uncommon: temporarily mild local irritation (e.g. itching, burning) and slight discharge may occur.
Maltese: Mhux komuni: tista' sseħħ irritazzjoni lokali ħafifa temporanja (eż. ħakk, ħruq) u tnixxija żgħira.
English: [invented name] is a cream for vaginal use which contains estradiol
Maltese: [isem ivvintat] huwa krema għall-użu vaġinali li fiha estradiol
English: The following adverse events have also been associated with oral and/or transdermal oestrogen therapy:
Maltese: Jistgħu jseħħu l-effetti sekondarji li ġejjin b'kura b'estroġenu orali u/jew transdermali:
English: Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
Maltese: bħala medja, fuq perjodu ta' 5 snin, 4 sa 7 minn kull 1000 huwa mistenni li jkollhom embolu tad-demm f'vina.