FrancophonIA/ELRC3.0 huggingface dataset:
English: The oestrogen contained in Zoely is 17β-estradiol, a natural oestrogen identical to the endogenous human 17β-estradiol.
Maltese: L-estroġenu li hemm f'Zoely hu 17β-estradiol, estroġenu naturali identiku għal 17β-estradiol endoġenu uman.
English: Zoely contains estradiol instead of ethinylestradiol.
Maltese: Zoely fih estradiol minflok ethinylestradiol.
English: Option 2)
Maltese: Għażla 2)
English: Method failure: 1.22 (upper limit 95 % confidence interval 2.18) Method and user failure: 1.16 (upper limit 95 % confidence interval 2.08)
Maltese: Falliment tal-Metodu 1.22 (95 % tal-limitu ta' fuq 2.18 intervall ta' kunfidenza) Metodu u falliment tal-utent: 1.16 (95 % tal-limitu ta' fuq 2.08 intervall ta' kunfidenza)
English: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Maltese: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
English: Hepatitis C
Maltese: Epatite Ċ
English: Option 1)
Maltese: Għażla 1)
English: Estradiol circulates in the blood bound to SHBG (37 %) and to albumin (61 %), while only approximately 1-2 % is unbound.
Maltese: Estradiol jiċċirkola fid-demm imwaħħal ma' SHBG (37 %) u mal-albumina (61 %), filwaqt li madwar 1-2 % biss ikun mhux imwaħħal.
English: • diabetes mellitus with vascular symptoms
Maltese: • dijabete mellitus b'sintomi vaskulari
English: The pharmacokinetics of nomegestrol acetate are not influenced by SHBG.
Maltese: Il-farmakokinetika ta' nomegestrol acetate mhijiex influwenzata minn SHBG.
English: You do not need to use an additional contraceptive method.
Maltese: M'hemmx bżonn li tuża metodu kontraċettiv addizzjonali.
English: o Major surgery with prolonged immobilisation (see section 4.4).
Maltese: o Kirurġija maġġuri b'immobilizzazzjoni fit-tul (ara sezzjoni 4.4).
English: Method failure: 0.40 (upper limit 95 % confidence interval 1.03) Method and user failure: 0.38 (upper limit 95 % confidence interval 0.97)
Maltese: Falliment tal-Metodu 0.40 (95 % tal-limitu ta' fuq 1.03 intervall ta' kunfidenza) Metodu u falliment tal-utent: 0.38 (95 % tal-limitu ta' fuq 0.97 intervall ta' kunfidenza)
English: During clinical trials, absence of withdrawal bleeding ranged over the cycles 1-12 from 18 % to 32 %.
Maltese: Waqt il-provi kliniċi, l-assenza ta' ħruġ ta' demm meta twaqqfet il-mediċina varjat f'ċikli 1-12 minn 18 % sa 32 %.
English: Pack sizes: 28, 84, 168 and 364 film-coated tablets.
Maltese: Daqsijiet tal-pakkett: 28, 84, 168 u 364 pillola miksija b'rita.
English: Tel.: +48 22 549 51 00 msdpolska@merck.com
Maltese: +48 22 549 51 00 msdpolska@merck.com
English: Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
Maltese: Nota: Għandha tiġi kkonsultata l-informazzjoni dwar il-preskrizzjoni tal-mediċini mogħtija fl-istess ħin biex jiġu identifikati interazzjonijiet possibbli.
English: Tumours
Maltese: Tumuri
English: Oral exogenous estradiol is extensively metabolized.
Maltese: Estradiol esoġenu orali jiġi metabolizzat b'mod estensiv.
English: Increasing age
Maltese: Avvanz fl-età
English: These are nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Maltese: Dawn huma nomegestrol acetate (progestogen) u estradiol (estroġen).
English: In total 3,434 women, aged 18-50, were enrolled and completed 33,828 cycles.
Maltese: B'kollox 3,434 mara minn età ta' bejn 18-50, ġew irreġistrati u lestew 33,828 ċiklu.
English: Zoely is a contraceptive pill that is used to prevent pregnancy.
Maltese: Zoely hu pillola kontraċettiva li tintuża biex tiġi evitata t-tqala.
English: Pulmonary embolism
Maltese: Emboliżmu fil-pulmun
English: • dry eye; contact lens intolerance
Maltese: • għajnejn xotti; intolleranza għal contact lenses
English: About 2 out of 10,000 women
Maltese: Madwar 2 minn 10,000 mara
English: Cervical cancer is caused by an infection with the human papilloma virus (HPV).
Maltese: Il-kanċer ċervikali hu kkawżat minn infezzjoni bil-virus tal-papilloma uman (HPV).
English: Nomegestrol acetate is metabolized into several inactive hydroxylated metabolites by liver cytochrome P450 enzymes, mainly CYP3A4 and CYP3A5 with possible contribution of CYP2C19 and CYP2C8.
Maltese: Nomegestrol acetate jiġi metabolizzat f'diversi metaboliti idrossilati inattivi minn enzimi ta' ċitokrom P450 fil-fwied, primarjament CYP3A4 u CYP3A5, b'kontribuzzjoni li tista' tingħata minn CYP2C19 u CYP2C8.
English: Risk of arterial thromboembolism (ATE)
Maltese: Riskju ta' tromboemboliżmu fl-arterji (ATE - arterial thromboembolism)
English: Oxidation of estrone and estradiol involves cytochrome P450 enzymes, mainly CYP1A2, CYP1A2 (extra hepatic), CYP3A4, CYP3A5, and CYP1B1 and CYP2C9.
Maltese: Lossidazzjoni ta' estrone u estradiol tinvolvi l-enzimi ta' ċitokrom P450, primarjament CYP1A2, CYP1A2 (ekstra epatiku), CYP3A4, CYP3A5, u CYP1B1 u CYP2C9.
English: Zoely contains lactose
Maltese: Zoely fih lactose
English: Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), iron oxide yellow (E172) and iron oxide black (E172)
Maltese: Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), iron oxide isfar (E172) u iron oxide iswed (E172)
English: Microcrystalline cellulose (E460) Crospovidone (E1201)
Maltese: Microcrystalline cellulose (E460)
English: Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Maltese: 1 Punt fin-nofs ta' firxa ta' 5-7 għal kull 10,000 mara f'sena, abbażi ta' riskju relattiv għal CHCs li fihom levonorgestrel kontra l-ebda użu ta' madwar 2.3 sa 3.6
English: The Zoely blister contains 28 tablets: 24 white tablets with the active substances (number 1-24) and 4 yellow tablets without active substances (number 25-28).
Maltese: Il-folja ta' Zoely fiha 28 pillola: 24 pillola bajda bis-sustanzi attivi (numru 1-24) u 4 pilloli sofor mingħajr sustanzi attivi (numru 25-28).
English: Do not use rhythm or temperature methods.
Maltese: Tużax il-metodi tar-ritmu jew tat-temperatura.
English: Lactose monohydrate (see section 2 ‘Zoely contains lactose'), microcrystalline cellulose (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and colloidal anhydrous silica Tablet coat (white active film-coated tablets):
Maltese: Qalba tal-pillola (pilloli bojod attivi u pilloli sofor tal-plaċebo miksija b'rita): Lactose monohydrate (ara sezzjoni 2 ‘Zoely fih lactose'), microcrystalline cellulose (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) u colloidal anhydrous silica Kisja tal-pillola (pilloli bojod attivi miksija b'rita):
English: • Contraceptive pills that contain two different hormones, like Zoely, are called ‘combined pills'.
Maltese: • Pilloli kontraċettivi li fihom żewġ ormoni differenti, bħal Zoely, huma msejħa ‘pilloli kombinati'.
English: Each yellow placebo film-coated tablet contains 61.76 mg of lactose monohydrate.
Maltese: Kull pillola safra tal-plaċebo miksija b'rita fiha 61.76 mg ta' lactose monohydrate.
English: Iron oxide black (E172)
Maltese: Iron oxide isfar (E172)
English: • if you have hereditary angioedema.
Maltese: • jekk għandek anġjoedema ereditarja.
English: Endometrial histology was investigated in a subgroup of women (n=32) in one clinical study after 13 cycles of treatment.
Maltese: L-istoloġija endometrijali ġiet investigata f'sottogrupp ta' nisa (n=32) fi studju kliniku wara 13-il ċiklu ta' kura.
English: Medicinal product subject to medical prescription.
Maltese: Wara li t-terapija bil-mediċina titwaqqaf.
English: • Nomegestrol acetate, the progestogen in Zoely, is derived from the hormone progesterone.
Maltese: • Nomegestrol acetate, il-progestogen f'Zoely, jinkiseb mill-ormon progesterone.
English: Ethnic groups No formal studies were performed to assess pharmacokinetics in ethnic groups.
Maltese: Gruppi etniċi Ma sar l-ebda studju formali biex tiġi evalwata l-farmakokinetika fi gruppi etniċi.
English: The apparent volume of distribution of nomegestrol acetate at steady-state is 1,645  576 L.
Maltese: Il-volum apparenti tad-distribuzzjoni ta' nomegestrol acetate fl-istat fiss hu ta' 1,645 ± 576 L.
English: SUN MON TUE WED THU FRI SAT MON TUE WED THU FRI SAT SUN TUE WED THU FRI SAT SUN MON WED THU FRI SAT SUN MON TUE THU FRI SAT SUN MON TUE WED FRI SAT SUN MON TUE WED THU SAT SUN MON TUE WED THU FRI
Maltese: Dan ifisser li int dejjem ser tibda folja ġdida fl-istess jum tal-ġimgħa, u wkoll li ser ikollok il-mestrwazzjoni bejn wieħed u ieħor fl-istess jiem kull xahar.
English: There is a dynamic equilibrium between estradiol, estrone and estrone-Sulfate due to various enzymatic activities including estradiol-dehydrogenases, sulfotransferases and aryl sulfatases.
Maltese: Hemm ekwilibriju dinamiku bejn estradiol, estrone u estrone-sulfate minħabba d-diversi attivitajiet enzimatiċi li jinkludu estradiol-dehydrogenases, sulfotransferases u aryl sulfatases.
English: In two randomized, open-label, comparative efficacy-safety trials, more than 3,200 women have been treated for up to 13 consecutive cycles with Zoely and more than 1,000 women with drospirenone 3 mg - ethinylestradiol 30 μg (21/7 regimen).
Maltese: F'żewġ provi open-label li fihom tqabblet l-effikaċja u s-sigurtà, aktar minn 3,200 mara ġew ikkurati sa 13-il ċiklu konsekuttiv b'Zoely u iktar minn 1,000 mara b'drospirenone 3 mg - ethinylestradiol 30 μg (kors ta' 21/7).
English: All adverse reactions are listed by system organ class and frequency; very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100) and rare ( 1/10,000 to < 1/1,000).
Maltese: Ir-reazzjonijiet avversi kollha huma elenkati skont il-klassi tas-sistemi u tal-organi u l-frekwenza; komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100) u rari (≥1/10,000 sa <1/1,000).
English: Nomegestrol acetate has a strong affinity for the human progesterone receptor and has an anti-gonadotropic activity, a progesterone receptor-mediated anti-oestrogenic activity, a moderate anti-androgenic activity, and is devoid of any oestrogenic, androgenic, glucocorticoid or mineralocorticoid activity.
Maltese: Nomegestrol acetate għandu affinità qawwija għar-riċettur tal-progesterone uman u għandu attività qawwija anti-gonadotropika, attività anti-estrogenika medjata minn riċettur ta' progesterone, attività moderata anti-androġenika, u m'għandu l-ebda attività estrogenika, androġenika, glukokortikojde jew mineralokortikojde.
English: o in a leg or foot (i.e., DVT)
Maltese: o f'riġel jew sieq (i.e., DVT) o fil-pulmun (i.e., PE)
English: After discontinuation of Zoely, return to ovulation in the first 28 days after last tablet intake was observed in 79 % of the women.
Maltese: Wara t-twaqqif ta' Zoely, ir-ritorn għall-ovulazzjoni fl-ewwel 28 jum wara l-aħħar teħid ta' pilloli kien osservat f'79 % tan-nisa.
English: [Box for placing day label stating:] Place day label here [Day numbering for each individual tablet:] Start,2, ….28 [Arrows indicating the sequence of the tablets:] 
Maltese: [Kaxxa biex tpoġġi t-tikketta tal-jum li tiddikjara:] Poġġi t-tikketta tal-jum hawnhekk [Numru tal-jum għal kull pillola individwali:] Ibda,2, ….28 [Il-vleġeġ jindikaw is-sekwenza tal-pilloli:] →
English: • With the use of the higher-dosed COCs (50 g ethinylestradiol) the risk of endometrial and ovarian cancer is reduced.
Maltese: • Bl-użu ta' COCs b'doża ogħla (50 µg ethinylestradiol) ir-riskju ta' kanċer endometrijali u tal-ovarji jitnaqqas.
English: In the Zoely group, acne was reported by 15.4 % of the women (versus 7.9 % in the comparator group), weight increased was reported by 8.6 % of the women (versus 5.7 % in the comparator group), and abnormal withdrawal bleeding (predominantly absence of withdrawal bleeding) was reported by 10.5 % of the women (versus 0.5 % in the comparator group).
Maltese: Fil-grupp ta' Zoely, akne ġiet irrappurtata minn 15.4 % tan-nisa (kontra 7.9 % fil-grupp komparatur), żieda fil-piż ġiet irrappurtata minn 8.6 % tan-nisa (kontra 5.7 % fil-grupp komparatur), u ħruġ anormali ta' demm meta tieqaf tieħu l-mediċina (il-biċċa l-kbira assenza ta' ħruġ ta' demm meta titwaqqaf il-mediċina) ġie rrappurtat minn 10.5 % tan-nisa (kontra 0.5 % fil-grupp komparatur).
English: Hepatic metabolism: Interactions can occur with substances that induce CYP450 enzymes, resulting in reduced concentrations of sex hormones and decreased effectiveness of combined oral contraceptives, including Zoely.
Maltese: Metaboliżmu fil-fwied: Jistgħu jseħħu interazzjonijiet mas-sustanzi li jinduċu l-enzimi CYP450, li jwasslu għal tnaqqis fil-konċentrazzjonijiet tal-ormoni tas-sess u tnaqqis fl-effikaċja tal-kontraċettivi kkombinati orali, inkluż Zoely.
English: The elimination half-life (t1/2) is 46 h (ranging from 28-83 h) at steady state.
Maltese: Il-half-life tal-eliminazzjoni (t1/2) hi ta' 46 siegħa (li tvarja minn 28-83 siegħa) fl-istat fiss.
English: • severe dyslipoproteinaemia.
Maltese: • Emorraġija vaġinali mhux dijanjostikata.
English: Available pharmacokinetic data are described in section 5.2.
Maltese: Dejta farmakokinetika disponibbli hi deskritta f'sezzjoni 5
English: Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus
Maltese: Dijabete mellitus, iperomosisteinimja, marda tal-valvs tal-qalb u fibrillazzjoni tal-atriju, dislipoproteinimja u lupus eritematosus sistemiku
English: Concomitant use of rifampicin decreases the AUC0-∞ of nomegestrol acetate by 95 % and increases the AUC0-tlast of estradiol by 25 %.
Maltese: L-użu fl-istess ħin ta' rifampicin inaqqas l-AUC0-∞ ta' nomegestrol acetate b'95 % u jżid l-AUC0-∞ ta' estradiol b'25 %.
English: • A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs.
Maltese: • Meta-analiżi minn 54 studju epidemjoloġiku wriet li kien hemm żieda żgħira fir-riskju relattiv (RR = 1.24) li jkun hemm kanċer tas-sider li jiġi ddijanjostikati f'nisa li bħalissa qed jużaw COCs.
English: • with increasing age (beyond about 35 years);
Maltese: • ma' avvanz fl-età (wara età ta' madwar 35 sena);
English: The increased risk of VTE during the postpartum period should be considered when re-starting Zoely (see section 4.2 and 4.4).
Maltese: Għandu jitqies ir-riskju ta' VTE waqt il-perjodu ta' wara t-twelid meta Zoely jinbeda mill-ġdid (ara sezzjonijiet 4.2 u 4.4).
English: Tablet core (white active and yellow placebo film-coated tablets) Lactose monohydrate
Maltese: Qalba tal-pillola (pilloli bojod attivi u pilloli sofor tal-plaċebo miksija b'rita) Lactose monohydrate
English: Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 and talc (E553b) Tablet coat (yellow placebo film-coated tablets):
Maltese: Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 u talc (E553b) Kisja tal-pillola (pilloli sofor tal-plaċebo miksija b'rita):
English: In the clinical trial performed with Zoely in the United States the following Pearl Indices for the age class 18-35 years were calculated:
Maltese: Fil-prova klinika li saret b'Zoely fl-Istati Uniti, l-Indiċi Pearl li ġejjin għall-klassi ta' età 18-35 sena ġew ikkalkulati:
English: Nomegestrol acetate is extensively bound to albumin (97-98 %), but does not bind to sex hormone binding globulin (SHBG) or corticoid binding globulin (CBG).
Maltese: Nomegestrol acetate (NOMAC) jeħel b'mod estensiv mal-albumina (97-98 %), iżda ma jeħilx malglobulina li teħel mal-ormon tas-sess (SHBG) jew globulina li teħel ma' kortikojd (CBG).
English: • disturbance in attention
Maltese: • disturbi fl-attenzjoni
English: Obesity (body mass index over 30 kg/m²)
Maltese: Obeżità (indiċi tal-piż tal-ġisem ta' aktar minn 30 kg/m2)
English: Tablet coating (yellow placebo film-coated tablets) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171)
Maltese: Kisja tal-pillola (pilloli sofor tal-plaċebo miksija b'rita) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171)
English: Dose-linearity was observed in the range 0.625-5 mg (assessed in fertile and post-menopausal women).
Maltese: Il-linearità tad-doża kienet osservata fil-medda ta' 0.625-5 mg (evalwata f'nisa fertili u dawk li diġà għaddew mill-menopawsa).
English: Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
Maltese: Prodotti li fihom levonorgestrel, norgestimate jew norethisterone huma assoċjati mal-aktar riskju baxx ta' VTE.
English: Table: Risk factors for VTE Risk factor
Maltese: Tabella: Fatturi ta' riskju għal VTE
English: Zoely 2.5 mg/1.5 mg tablets nomegestrol acetate/estradiol
Maltese: Zoely 2.5 mg/1.5 mg pilloli nomegestrol acetate/estradiol
English: The absolute bioavailability of nomegestrol acetate after a single dose is 63 %.
Maltese: Il-bijodisponibilità ta' nomegestrol acetate wara doża waħda hi ta' 63 %.
English: Each white active film-coated tablet contains 57.71 mg of lactose monohydrate.
Maltese: Kull pillola bajda miksija b'rita fiha 57.71 mg ta' lactose monohydrate.
English: Temporary symptoms suggest the event is a transient ischaemic attack (TIA).
Maltese: Sintomi temporanji jissuġġerixxu li l-avveniment huwa attakk iskemiku temporanju (TIA - transient ischaemic attack).
English: Concomitant use of ketoconazole (200 mg single dose) does not modify estradiol metabolism whereas increases in the peak concentration (85 %) and AUC0-∞ (115 %) of nomegestrol acetate were observed, which were of no clinical relevance.
Maltese: L-użu fl-istess ħin ta' ketoconazole (doża waħda ta' 200 mg) ma jbiddilx il-metaboliżmu ta' estradiol filwaqt li kienu osservati żidiet fil-konċentrazzjoni massima (85 %) u AUC0-∞ (115 %) ta' nomegestrol acetate, li ma kinux ta' rilevanza klinika.
English: The distribution of exogenous and endogenous estradiol is similar.
Maltese: Id-distribuzzjoni ta' estradiol esoġenu u endoġenu hi simili.
English: • in veins (referred to as ‘venous thrombosis', ‘venous thromboembolism' or VTE)
Maltese: • fil-vini (magħruf bħala ‘trombożi fil-vini', ‘tromboemboliżmu fil-vini' jew VTE [venous thromboembolism])
English: Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
Maltese: Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
English: o Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency.
Maltese: o Predispożizzjoni ereditarja jew akkwistata magħrufa għal tromboemboliżmu fil-vini, bħal reżistenza għall-APC (inkluż il-Fattur V Leiden), defiċjenza ta' antithrombin III, defiċjenza tal-proteina Ċ, defiċjenza tal-proteina S.
English: Following delivery or second-trimester abortion
Maltese: Wara l-ħlas jew abort fit-tieni trimestru
English: • if you have epilepsy (see in section 2 ‘Other medicines and Zoely');
Maltese: • jekk għandek epilessija (ara f'sezzjoni 2 ‘Mediċini oħra u Zoely');
English: Vascular disorders hot flush venous thromboembolism
Maltese: Disturbi vaskulari fwawar tromboemboliż mu fil-vini
English: In the clinical trial performed with Zoely in the European Union the following Pearl Indices for the age class 18-35 years were calculated:
Maltese: Fil-prova klinika li saret fl-Unjoni Ewropea b'Zoely, l-indiċi Pearl li ġejjin għall-klassi ta' età ta' 18-35 sena kienu kkalkulati:
English: • Presence or risk of arterial thromboembolism (ATE) o Arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris).
Maltese: • Il-preżenza jew ir-riskju ta' tromboemboliżmu fl-arterji (ATE - arterial thromboembolism) o Tromboemboliżmu fl-arterji - tromboemboliżmu attwali fl-arterji, storja ta' tromboemboliżmu fl-arterji (eż. infart mijokardijaku) jew kondizzjoni prodromika (eż. anġina pectoris).
English: • in the arteries (referred to as an ‘arterial thrombosis', ‘arterial thromboembolism' or ATE).
Maltese: • fl-arterji (magħruf bħala ‘trombożi fl-arterji', ‘tromboemboliżmu fl-arterji' jew ATE [arterial thromboembolism]).
English: Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
Maltese: Ipertrigliċeridemija ġiet assoċjata ma' riskju ogħla li tiżviluppa pankreatite (infjammazzjoni tal-frixa);
English: 28 film-coated tablets 84 film-coated tablets 168 film-coated tablets 364 film-coated tablets
Maltese: 28 pillola miksija b'rita 84 pillola miksija b'rita 168 pillola miksija b'rita 364 pillola miksija b'rita
English: Stroke
Maltese: Kumment
English: Risk of venous thromboembolism (VTE)
Maltese: Riskju ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism)
English: The metabolism of exogenous and endogenous estradiol is similar.
Maltese: Il-metaboliżmu ta' estradiol esoġenu u endoġenu hu simili.
English: • Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see section 4.8).
Maltese: • Burdata depressa u depresjoni huma effetti mhux mixtieqa magħrufa sewwa mill-użu ta' kontraċettivi tal-ormoni (ara sezzjoni 4.8).
English: These include medicines used to treat: - epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate); - tuberculosis (e.g. rifampicin); - HIV infections (e.g. rifabutin, ritonavir, efavirenz); - Hepatitis C virus (HCV) infection (e.g. boceprevir, telaprevir); - other infectious diseases (e.g. griseofulvin); - high blood pressure in the blood vessels in the lungs (bosentan).
Maltese: Dawn jinkludu mediċini li jintużaw biex jikkuraw: - epilessija (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate); - tuberkulosi (eż. rifampicin); - infezzjonijiet bl-HIV (eż. rifabutin, ritonavir, efavirenz); - infezzjoni bil-virus tal-Epatite Ċ (HCV - Hepatitis C virus) (eż. boceprevir, telaprevir); - mard infettiv ieħor (eż. griseofulvin). - pressjoni tad-demm għolja fil-vini/arterji tal-pulmun (bosentan)
English: Nomegestrol acetate causes in vitro no notable induction or inhibition of any cytochrome P450 enzymes and has no clinically relevant interaction with the P-gp transporter.
Maltese: Nomegestrol acetate ma jikkawża l-ebda induzzjoni jew inibizzjoni notevoli in vitro ta' kwalunkwe enzimi ta' ċitokrom P450 u m'għandu l-ebda interazzjoni klinikament rilevanti mat-trasportatur P-gp.
English: Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease
Maltese: Kondizzjonijiet mediċi oħra assoċjati ma' VTE Kanċer, lupus eritematosus sistemiku, sindrome uremiku emolitiku, marda kronika infjammatorja tal-musrana (marda ta' Crohn jew kolite ulċerattiva) u marda taċ-ċellula forma ta' minġel (sickle cell disease).
English: o Cerebrovascular disease - current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA).
Maltese: o Mard ċerebrovaskulari - puplesija attwali, storja ta' puplesija jew kondizzjoni prodromika (eż. attakk iskemiku temporanju, TIA - transient ischaemic attack).
English: PVC/aluminium blister containing 28 film-coated tablets (24 white film-coated tablets and 4 yellow film-coated tablets).
Maltese: Folja tal-PVC/aluminju li fiha 28 pillola miksija b'rita (24 pilloli bojod miksija b'rita u 4 pilloli sofor miksija b'rita).
English: Arterial thromboembolic events may be fatal.
Maltese: Avvenimenti ta' tromboemboliżmu fl-arterji jistgħu jkunu fatali.
English: • Undiagnosed vaginal bleeding.
Maltese: • dislipoproteinimja qawwija.
English: • Epidemiological studies in women who use low dose (< 50 µg ethinylestradiol) combined hormonal contraceptives have found that out of 10,000 women between 6 and 12 will develop a VTE in one year.
Maltese: • Studji epidemjoloġiċi f'nisa li jużaw kontraċettivi kkombinati tal-ormoni ta' doża baxxa (< 50 µg ethinylestradiol) sabu li minn 10,000 mara bejn 6 u 12 jiżviluppaw VTE f'sena waħda.