FrancophonIA/ELRC3.0 huggingface dataset:
English: Intrarosa has not been studied in women with uncontrolled hypertension (blood pressure above 140/90 mmHg) and cardiovascular disease.
Maltese: Intrarosa ma ġiex studjat f'nisa b'ipertensjoni mhux ikkontrollata (pressjoni tad-demm 'il fuq minn 140/90 mmHg) u b'mard kardjovaskulari.
English: Uncommon (≥ 1/1,000 to < 1/100)
Maltese: Mhux komuni (> 1/1,000 sa
English: • HRT use does not improve cognitive function.
Maltese: • L-HRT ma ttejjibx il-funzjoni konjittiva.
English: Exogenous prasterone is metabolized in the same manner as endogenous prasterone.
Maltese: Prasterone eżoġenu jiġi metabolizzat bl-istess mod bħal prasterone endoġenu.
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 riskju miżjud relattiv li jiġi żviluppat tromboemboliżmu filvini (VTE), jiġifieri trombożi fil-vini fil-fond jew emboliżmu pulmonari.
English: • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency);
Maltese: • Jekk għandek disturb tal-koagulazzjoni (bħal nuqqas ta' proteina C, proteina S, jew antitrombin);
English: Theramex Belgium BVBA Tél/Tel: + 32 (0) 28088080
Maltese: Tél/Tel: + 32 (0) 28088080
English: The Cmax and AUC0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the Intrarosa pessary compared to those receiving placebo but all remained within normal values of postmenopausal women (< 10 pg estradiol/mL; < 0.26 ng testosterone/mL) as measured by validated mass spectrometry-based assays for both the study samples and reference values.
Maltese: Is-Cmax u AUC0-24 tal-metaboliti testosteron u estradiol kienu wkoll ftit ogħla f'nisa kkurati bil-pessarju ta' Intrarosa meta mqabbel ma' dawk li rċivew il-plaċebo iżda kollha baqgħu fil-valuri normali ta' nisa wara l-menopawża (< 10 pg estradiol/mL; < 0.26 ng testosterone/mL) kif imkejjel minn assaġġi bbażati fuq spettrometrija ta' massa validati għal kemm il kampjuni tal-istudju u l-valuri ta' referenza.
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 globulina li teħel mat-tirojde (TBG, thyroid binding globulin), li jwasslu għal żieda fiċ-ċirkolazzjoni tal-ormon totali tat-tirojde, kif imkejjel bil-jodju li jeħel mal-proteini (PBI, protein-bound iodine), il-livelli T4 (permezz tal-immunoassaġġ tal-kolonna jew tar-radju) jew livelli
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Maltese: NUMRU TAL-LOTT<, DONAZZJONI U KOWD TAL-PRODOTT>
English: Intrarosa is only used in adult women.
Maltese: Intrarosa jintuża biss f'nisa adulti.
English: Cases of abnormal Pap smears corresponding to ASCUS or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported in women treated with the 6.5 mg dose (common frequency).
Maltese: Skwamuża ta' Grad Baxx (LSIL, Low Grade Squamous Intraepithelial Lesion) f'nisa kkurati bid-doża ta' 6.5 mg (frekwenza komuni).
English: Risk of coronary artery disease
Maltese: Riskju ta' mard tal-arterja koronarja
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, ceruloplasmin).
Maltese: Jaf ikun hemm żieda fi proteini fil-plażma oħra (sottostrat ta' anġjotensinoġen/renin, alpha-I-antitrypsin,
English: Each pessary contains 6.5 mg of prasterone.
Maltese: Kull pessarju fih 6.5 mg ta' prasterone.
English: Intrarosa contains the active ingredient prasterone, i.e. dehydroepiandrosterone (DHEA), which is biochemically and biologically identical to the endogenous human DHEA, a precursor steroid which is inactive by itself and it is converted into oestrogens and androgens.
Maltese: Intrarosa fih is-sustanza attiva prasterone, jiġifieri dehydroepiandrosterone (DHEA), li bijokimikament u bijoloġikament hija identika għad-DHEA tal-bniedem endoġenu, sterojd prekursur li minnu nnifsu mhux attiv u li jiġi kkonvertit f'estroġeni u androġeni.
English: One case of pulmonary embolism has been reported in the 6.5 mg group and one in the placebo group during clinical trials.
Maltese: Ġie rrappurtat każ wieħed ta' emboliżmu pulmonari fil-grupp ta' 6.5 mg u wieħed fil-grupp talplaċebo waqt il-provi kliniċi.
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 innuqqas huwa “sever” (eż. nuqqas ta' antitrombin, proteina S, jew proteina C jew kombinazzjoni ta' difetti) l-HRT tiġi kontraindikata.
English: Intrarosa has not been studied in women with abnormal Pap smears (Atypical Squamous Cells of Undetermined Significance (ASCUS)) or worse.
Maltese: Intrarosa ma ġiex studjat f'nisa b'Pap smears anormali (Ċelluli Skwamużi Atipiċi ta' Sinifikanza Mhux Determinata (ASCUS, Atypical Squamous Cells of Undetermined Significance)) jew agħar.
English: Cases of abnormal Pap smears either Atypical Squamous Cells of Undetermined Significance (ASCUS) or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported with a common frequency in women treated with Intrarosa for 52 weeks (see section 4.4).
Maltese: Ġew irrappurtati każijet ta' Pap smears anormali jew Ċelluli Skwamużi Atipiċi ta' Sinifikanza Mhux Determinata (ASCUS) jew Leżjoni Intraepiteljali Skwamuża ta' Grad Baxx (LSIL) bi frekwenza komuni f'nisa kkurati b'Intrarosa għal 52 ġimgħa (ara sezzjoni 4.4).
English: The relative risk does not change with age or time since menopause.
Maltese: Ir-riskju relattiv ma jinbidilx mal-età jew maż-żmien mill-menopawża.
English: Risk ratio and 95%CI
Maltese: Proporzjon ta' riskju u 95 %CI
English: • Tear off one wrapped pessary from the 7-pessary strip.
Maltese: • Qaxxar pessarju wieħed ippakkjat mill-istrixxa ta' 7 pessarji.
English: Intrarosa is thus different from the oestrogens preparations since it delivers also androgen metabolites.
Maltese: Għalhekk Intrarosa huwa differenti millpreparazzjonijiet tal-estroġeni minħabba li dan jagħti wkoll metaboliti ta' androġenu.
English: • If you have a rare blood problem called “porphyria” which is passed down in families (inherited);
Maltese: • Jekk għandek problema rari tad-demm imsejħa “porfirja” li tingħadda fil-familji (tintiret);
English: • gall bladder disease
Maltese: • għandek kanċer.
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 ta' twaħħil oħra jistgħu jkunu għoljin fis-seru, jiġifieri globulina li teħel mal-kortikojde (CBG, corticoid binding globulin), globulina li teħel mal-ormoni tas-sess (SHBG, sex-hormonebinding globulin) li jwasslu għal żieda fil-kortikosterojdi li jiċċirkolaw u fl-isterojdi tas-sess, rispettivament.
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 randomizzata kkontrollata bi plaċebo (studju WHI) u l-akbar studju epidemjoloġiku (MWS).
English: After 12 weeks of daily treatment with a prasterone 6.5 mg pessary (n=81 in Trial 1 and n=325 in Trial 2), the change from baseline, in comparison with placebo treatment (n=77 in Trial 1 and n=157 in Trial 2), demonstrated significant improvements of the 3 co-primary endpoints compared to placebo in both studies, namely increase of the percentage of superficial cells (p<0.0001), decrease of the percentage of parabasal cells (p<0.0001), and decrease in the vaginal pH (p<0.0001).
Maltese: Wara 12-il ġimgħa ta' kura ta' kuljum b'prasterone 6.5 mg pessarju (n=81 fi Prova 1 u n=325 fi Prova 2), il-bidla mil-linja bażi, meta mqabbel ma' kura bi plaċebo n=77 fi Prova 1 u n=157 fi Prova 2), uriet titjib sinifikanti tat-tliet punti tat-tmiem ko-primarji meta mqabbel mal-plaċebo fiż-żewġ studji, prinċipalment żieda fil-perċentwal ta' ċelluli superfiċjali (p<0.
English: How to use Intrarosa
Maltese: X'fih Intrarosa
English: (years)
Maltese: (snin)
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-punti fokali residwi ta' endometrijożi.
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Maltese: Waqt it-trattament, huma rrakkomandati visti mediċi perjodiċi ta' frekwenza u natura adatti għall-mara individwali.
English: • diabetes;
Maltese: • puplesija;
English: It is available in blister packs of 28 pessaries with 6 applicators.
Maltese: Dan jiġi f'pakkett folji ta' 28 pessarju b'6 applikaturi.
English: Additional cases per 1000 HRT users over 5 years
Maltese: Każijiet addizzjonali għal kull 1000 utent matul 5 snin
English: Incidence per 1000 women in placebo arm over 5 years
Maltese: 1000 mara fil-fergħa tal plaċebo matul 5 snin
English: Do not use this medicine after the expiry date which is stated on the carton and blisters after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folji wara EXP.
English: • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE);
Maltese: • marda tas-sistema immuni li taffettwa ħafna organi tal-ġisem (lupus erythematosus sistemiku,
English: Cervical/ uterine polyps Breast mass (benign)
Maltese: Massa tas-sider (bennina)
English: The adverse reaction observed with prasterone 6.5 mg pessaries obtained from clinical studies is tabulated below.
Maltese: Ir-reazzjoni avversa osservata bi prasterone 6.5 mg pessarji miksuba mill-istudji kliniċi hija mniżżla f'tabella hawn taħt.
English: WHI Studies - Additional risk of VTE over 5 years' use
Maltese: Studji WHI - Riskju addizzjonali ta' VTE matul użu ta' 5 snin
English: For more information about these side effects, see section 2.
Maltese: Għal aktar informazzjoni dwar dawn l-effetti sekondarji, ara sezzjoni 2.
English: If you are going to have surgery, tell the surgeon that you are taking Intrarosa.
Maltese: Jekk se tagħmel kirurġija, għid lill-kirurgu tiegħek li qed tieħu Intrarosa.
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users.
Maltese: Għan-nisa li għandhom bejn 50 sa 54 sena u li ilhom jieħdu l-HRT għal 5 snin, dan jirriżulta f'madwar każ wieħed addizzjonali għal kull 2000 utent.
English: On the 389 evaluable end-of-study endometrial biopsies performed after 52 weeks of treatment with Intrarosa, no histological abnormalities were reported on the biopsies.
Maltese: Fuq it-389 bijopsija endometrijali li setgħu jiġu evalwati tal-aħħar tal-istudju li saru wara 52 ġimgħa ta' kura b'Intrarosa, ma ġiet irrappurtata l-ebda anormalità istoloġika fuq il-bijopsiji.
English: - The only other ingredient is the hard fat (adeps solidus).
Maltese: - L-unika sustanza mhux attiva l-oħra hija x-xaħam iebes (adeps solidus).
English: One case of breast cancer at week 52 has been reported on 1196 women who have been exposed with the 6.5 mg dose which is below the incidence rate observed in the normal population of the same age.
Maltese: Ġie rrappurtat każ wieħed ta' kanċer tal-ovarji f'1196 mara li ġew esposti bid-doża ta' 6.5 mg li hija inqas mir-rata ta' inċidenza osservata fil-popolazzjoni normali tal-istess età.
English: • changes in the nipple;
Maltese: • bidliet fin-nippla;
English: Fertility Intrarosa is not indicated in fertile women.
Maltese: Intrarosa mhuwiex indikat f'nisa fertili.
English: The beneficial effects on the symptoms and signs of vulvar and vaginal atrophy are exerted through activation of the vaginal oestrogen and androgen receptors.
Maltese: L-effetti ta' benefiċċju fuq is-sintomi u ssinjali ta' atrofija vulvari u vaġinali joħorġu mill-attivazzjoni tar-riċetturi tal-estroġenu u l-androġenu vaġinali.
English: − with a uncommon frequency (may affect up to 1 in 100 people): benign cervical or uterine polyps, benign breast mass.
Maltese: - bi frekwenza mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): polipi ċervikali jew fl utru bennini, massa tas-sider bennina.
English: • The risk of coronary artery disease is slightly increased in users of combined oestrogen-progestagen HRT over the age of 60 (see section 4.4).
Maltese: • Ir-riskju ta' mard tal-arterja koronarja huwa kemxejn miżjud f'utenti ta' HRT b'estroġenu u proġestoġenu flimkien li għandhom aktar minn 60 sena (ara sezzjoni 4.4).
English: • The use of oestrogen-only and oestrogen + progestagen therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Maltese: • L-użu ta' terapija b'estroġenu biss u estroġenu flimkien ma' proġestoġenu huwa assoċjat ma' riskju miżjud relattiv sa ta' 1.5 darbiet aktar ta' puplesija iskemika.
English: If you have a premature menopause the risks of using HRT may be different.
Maltese: Jekk għandek menopawża prematura, ir-riskji tal-użu ta' HRT jistgħu jkunu differenti.
English: • The level of risk is dependent on the duration of use (see section 4.4).
Maltese: • Il-livell ta' riskju huwa dipendenti mid-durata ta' użu (ara sezzjoni 4.4).
English: • any of the conditions mentioned in the ‘DO NOT take Intrarosa' section;
Maltese: • kwalunkwe waħda mill-kondizzonijiet imsemmija fis-sezzjoni “TIĦUX Intrarosa”;
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Maltese: VTE wara li tinbeda t-terapija, il-mediċina għandha titwaqqaf.
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 riskju miżjud ta' VTE u l-HRT tista' żżid dan ir-riskju.
English: • Previous or current venous thromboembolism (deep vein thrombosis, pulmonary embolism);
Maltese: • koagulazzjoni fil-vini tas-saqajn jew fil-pulmuni (tromboemboliżmu fil-vini);
English: If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy.
Maltese: Jekk għaddew inqas minn 12-il xahar mill-aħħar perjodu menstruwali tiegħek jew jekk għandek inqas minn 50 sena, xorta jaf teħtieġ tuża kontraċezzjoni addizzjonali biex tipprevjeni t-tqala.
English: - A history of endometrial hyperplasia (see below) - Epilepsy - Asthma - Otosclerosis
Maltese: - Ipertensjoni - Disturbi fil-fwied (eż. adenoma fil-fwied)
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 waqt it-terapija ta' sostituzzjoni tal-estroġenu jew ta' sostituzzjoni tal-ormoni, peress li ġew irrappurtati każijiet rari ta' żidiet kbar ta' trigliċeridi fil-plażma li wasslu għal pankreatite b'terapija bl-estroġenu f'din il-kondizzjoni.
English: The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in non-users, especially during the first year of taking it.
Maltese: Ir-riskju ta' koagulazzjoni fil-vini huwa madwar 1.3 sa 3 darbiet ogħla fl-utenti tal-HRT milli f'dawk li mhumiex utenti, speċjalment matul l-ewwel sena ta' teħid.
English: The most bothersome symptom (MBS) dyspareunia (co-primary endpoint) was assessed at baseline and 12 weeks with the severity scored as follows: None=0, Mild=1, Moderate=2, Severe=3.
Maltese: Xejn=0, Ħafifa=1, Moderata=2, Severa=3.
English: • To wash the applicator:
Maltese: • mard tal-marrara:
English: Dyspareunia
Maltese: Plaċebo
English: If you need to have surgery
Maltese: Kondizzjonijiet li jeħtieġu superviżjoni
English: • If you are allergic (hypersensitive) to prasterone or any of the other ingredients of Intrarosa (listed in section 6 Further information).
Maltese: • Jekk inti allerġika (għandek sensittività eċċessiva) għal prasterone jew għal xi sustanza oħra ta' Intrarosa (imniżżla fis-sezzjoni 6 Aktar informazzjoni).
English: Million Women study- Estimated additional risk of breast cancer after 5 years' use
Maltese: Studju ta' Miljun Mara - Riskju addizzjonali stmat ta' kanċer tas-sider wara użu ta' 5 snin
English: CEE oestrogen-only
Maltese: Kanċer tal-ovarji
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Maltese: Hemm tnaqqis fit-teħid tar-reżina T3, u dan jirrifletti t-TBG għoli.
English: • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”);
Maltese: • riskju miżjud li tiġi żviluppata l-koagulazzjoni (ara “Koagulazzjoni f'vina (trombożi)”);
English: • This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age, see section 4.4.
Maltese: • Dan ir-riskju relattiv mhuwiex dipendenti mill-età jew mid-durata ta' użu, iżda peress li r-riskju tal-linja bażi jiddependi ħafna mill-età, ir-riskju globali ta' puplesija fin-nisa li jużaw l-HRT ser jiżdied mal-età, ara sezzjoni 4.4.
English: US WHI studies - additional risk of breast cancer after 5 years' use
Maltese: WHI tal-Istati Uniti - riskju addizzjonali ta' kanċer tas-sider wara użu ta' 5 snin
English: Free or biological active hormone concentrations are unchanged.
Maltese: Il-konċentrazzjonijiet liberi jew bioloġikament attivi jibqgħu l-istess.
English: The distribution of intravaginal (exogenous) prasterone is mainly local but some increase in systemic exposure is observed especially for the metabolites but within normal values.
Maltese: Id-distribuzzjoni ta' prasterone fil-vaġina (eżoġenu) hija prinċipalment lokali iżda ġiet osservata ftit żieda fl-esponiment sistemiku speċjalment għall-metaboliti iżda fil-valuri normali.
English: • migraine or severe headaches;
Maltese: • ġebel fil-marrara;
English: Additional cases per 1000 HRT users
Maltese: Każijiet addizzjonali għal kull 1000 utent ta' HRT
English: Before initiating Intrarosa, a complete personal and family medical history should be taken.
Maltese: Qabel ma jinbeda Intrarosa, għandha ssir storja medika personali u tal-familja kompluta.
English: • Systemic 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 sistemika hija assoċjata ma' 1.3-3 darbiet ir-riskju li jiġi żviluppat tromboemboliżmu fil-vini
English: For more information, see ‘Blood clots in a vein (thrombosis)'
Maltese: Għal aktar informazzjoni, ara “Koagulazzjoni f'vina (trombożi)”.
English: • Intrarosa may weaken condoms, diaphragms and cervical caps made of latex.
Maltese: • Intrarosa jista' jnaqqas l-effettività tal-kondoms, tad-dijaframmi jew tal-għotjien ċervikali magħmulin mil-latex.
English: Once you have started on Intrarosa you should see your doctor for regular check-ups (at least every 6 months).
Maltese: Ladarba tkun bdejt fuq Intrarosa għandek tara t-tabib tiegħek għal visti mediċi regolari (tal-inqas kull 6 xhur).
English: Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
Maltese: Intrarosa huwa indikat għat-trattament ta' atrofija vulvari u vaġinali f'nisa ta' wara l-menopawża li jkollhom sintomi moderati sa severi.
English: White to off-white, bullet-shaped pessary approximately 28 mm long and 9 mm in diameter at its widest end.
Maltese: Pessarju f'forma ta' balla abjad għal jagħti fl-abjad, twil madwar 28 mm u b'dijametru ta' 9 mm fit tarf oħxon tiegħu.
English: At these check-ups, discuss with your doctor the benefits and risks of continuing with Intrarosa.
Maltese: F'dawn il-visti mediċi, iddiskuti mat-tabib tiegħek il-benefiċċji u r-riskji li tkompli b'Intrarosa.
English: You may need to stop taking Intrarosa about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein).
Maltese: Intrarosa madwar 4 sa 6 ġimgħat qabel l-operazzjoni biex tnaqqas ir-riskju ta' koagulazzjoni (ara sezzjoni 2, Koagulazzjoni f'vina).
English: Physiological responses (objective measures)
Maltese: Risponsi fiżjoloġiċi (kejl objettiv)
English: How to store Intrarosa
Maltese: Kif jaħdem Intrarosa
English: • Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations.
Maltese: • Kwalunkwe riskju miżjud fl-utenti ta' terapija b'estroġenu biss huwa sostanzjalment aktar baxx minn dak osservat f'utenti ta' kombinazzjonijiet ta' estroġenu u proġestoġenu.
English: The following side effects have been reported with HRT containing estrogens but not with Intrarosa during clinical trials:
Maltese: L-effetti sekondarji li ġejjin ġew irrappurtati b'HRT li fiha estroġeni iżda mhux b'Intrarosa waqt ilprovi kliniċi:
English: Non-interventional PASS - Drug Utilisation Study (DUS) to describe the baseline characteristics, utilisation patterns of EU postmenopausal women initiating treatment with Intrarosa and to assess whether EU prescribers abide by the contraindications stated in the EU SmPC.
Maltese: Utilisation Study) biex jiddeskrivi l-karatteristiċi fil-linja bażi, it-tendenzi ta' użu ta' nisa ta' wara l-menopawża fl-UE li jibdew kura b'Intrarosa u biex jivvaluta jekk ilpreskriventi fl-UE jikkonformawx mal-kontraindikazzjonijiet iddikjarati fl-SmPC tal-UE.
English: There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65.
Maltese: Hemm xi evidenza ta' riskju ogħla ta' telf tal memorja f'nisa li jibdew jużaw HRT wara l-età ta' 65.
English: Apart from the main two 12-week phase III clinical studies, the safety data of Intrarosa has also been obtained from one non comparative open-label safety study of one year.
Maltese: III ta' 12-il ġimgħa, id-data ta' sigurtà ta' Intrarosa nkisbet ukoll minn studju dwar is-sigurtà open-label mhux komparattiv ta' sena.
English: Table 1: Primary Efficacy Analysis - Change from Baseline to Week 12 in the Most Bothersome Symptom Dyspareunia (ITT Population; LOCF)
Maltese: Tabella 1:Analiżi tal-Effikaċja Primarja - Bidla mil-Linja Bażi għal Ġimgħa 12 fl-Aktar
English: It is not known if this medicine affects fertility.
Maltese: Għadu mhuwiex magħruf jekk din ilmediċina taffetwax il-fertilità fin-nisa.
English: The occurrence of such an event is more likely in the first year of using HT (see section 4.4).
Maltese: Mhuwiex meħtieġ li jitwaqqaf Intrarosa jekk ikun hemm tnixxija vaġinali (ara sezzjoni 4.4).
English: • various skin disorders: - discoloration of the skin especially of the face or neck known as “pregnancy patches” (chloasma); - painful reddish skin nodules (erythema nodosum); - rash with target-shaped reddening or sores (erythema multiforme).
Maltese: • jekk tinnota sinjali ta' koagulazzjoni, bħal: - nefħa b'uġigħ u ħmura tas-saqajn; - uġigħ f'daqqa fis-sider; - diffikultajiet biex tieħu nifs.
English: Cases of ovarian and breast cancer have rarely been reported in women treated with 6.5 mg of prasterone for 52 weeks.
Maltese: Rari li ġew irrappurtati każijiet ta' kanċer tal-ovarji u tas-sider f'nisa kkurati b'6.5 mg ta' prasteronegħal 52 ġimgħa.
English: Elimination Systemic elimination has not been studied specifically for this application.
Maltese: L-eliminazzjoni sistemika ma ġietx studjata speċjalment għal din l-applikazzjoni.
English: ASCUS or LGSIL), weight fluctuations (either increase or decrease);
Maltese: ASCUS jew LGSIL), fluttwazzjonijiet fil-piż (jew żieda jew tnaqqis);
English: Other conditions observed with HRT
Maltese: Kondizzjonijiet oħra osservati b'HRT