FrancophonIA/ELRC3.0 huggingface dataset:
English: Day 18-24 of white active tablet intake (see picture and schedule) There is a particularly high risk of becoming pregnant if you miss white active tablets close to the yellow placebo tablet interval.
Maltese: Jum 18-24 tat-teħid tal-pillola bajda attiva (ara l-istampa u l-iskeda) Hemm riskju partikularment għoli li toħroġ tqila jekk ma tiħux il-pilloli bojod attivi qrib l-intervall tal-pilloli sofor tal-plaċebo.
English: Maximal enzyme induction is generally observed within a few weeks.
Maltese: Induzzjoni massima tal-enzimi ġeneralment tiġi osservata fi żmien ftit ġimgħat.
English: An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4.
Maltese: Żieda fir-riskju ta' avvenimenti trombotiċi u tromboemboliċi fl-arterji u fil-vini, inkluż infart mijokardijaku, puplesija, attakki iskemiċi temporanji, trombożi fil-vini u emboliżmu fil-pulmun kienu osservati f'nisa li jużaw CHCs, u huma diskussi f'aktar dettall fis-sezzjoni 4.4.
English: For breast-feeding women see section 4.6.
Maltese: Għal nisa li jkunu qed ireddgħu, ara sezzjoni 4.6.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and oestrogens, fixed combinations, ATC code: G03AA14.
Maltese: Ormoni tas-sess u modulaturi tas-sistema ġenitali, proġestoġeni u estroġeni, kumbinazzjonijiet fissi, Kodiċi ATC:
English: It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”.
Maltese: Huwa importanti b'mod partikolari li taqra s-sintomi ta' tagħqid tad-demm - ara sezzjoni 2 “Tagħqid tad-demm”.
English: If she is 24 or more hours late in taking any active tablet, contraceptive protection may be reduced.
Maltese: Jekk il-mara tkun inqas minn 24 siegħa tard fit-teħid ta' kwalunkwe pillola attiva, il-protezzjoni kontraċettiva ma titnaqqasx.
English: Musculoskeletal and connective tissue disorders sensation of heaviness
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi sensazzjoni ta' toqol
English: The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
Maltese: Ir-riskju jiddependi mir-riskju naturali tiegħek ta' VTE u t-tip ta' kontraċettiv ikkombinat tal-ormoni li tkun qed tieħu.
English: [Second day label sheet for box of 3 blisters stating, twice:]
Maltese: [Folja tat-tikketta tat-tieni jum għal kaxxa ta' 3 folji li tiddikjara, darbtejn:]
English: Advice in case of gastro-intestinal disturbances
Maltese: Parir f'każ ta' disturbi gastrointestinali
English: België/Belgique/Belgien Theramex Belgium BVBA Tél/Tel: + 32 28 08 80 80
Maltese: België/Belgique/Belgien Theramex Belgium BVBA
English: The elimination half-life of metabolites was not determined.
Maltese: Il-half-life tal-eliminazzjoni tal-metaboliti ma ġietx stabbilita.
English: General disorders and administration site conditions irritability, oedema hunger
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata irritabilità, edema ġuħ
English: • decreased interest in sex; depression/depressed mood; mood changes
Maltese: • tnaqqis ta' interess fis-sess; dipressjoni/burdata dipressa; tibdil fil-burdata
English: Particularly important to consider if other risk factors also present.
Maltese: Importanti b'mod partikolari f'nisa b'fatturi addizzjonali ta' riskju.
English: o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4).
Maltese: o Riskju kbir ta' tromboemboliżmu fil-vini minħabba l-preżenza ta' fatturi ta' riskju multipli (ara sezzjoni 4.4).
English: In addition to the above mentioned adverse reactions, hypersensitivity reactions have been reported in Zoely users (frequency unknown).
Maltese: Apparti r-reazzjonijiet avversi msemmija hawn fuq, reazzjonijiet ta' sensittività eċċessiva ġew irrapportati f'utenti ta' Zoely (frekwenza mhux magħrufa).
English: Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 months).
Maltese: Ħruġ irregolari ta' demm vaġinali normalment jieqaf ġaladarba ġismek ikun aġġusta għall-pillola (normalment wara madwar 3 xhur).
English: Contraceptive protection is not reduced.
Maltese: Il-protezzjoni kontraċettiva ma titnaqqasx.
English: In the meantime, use a non-hormonal contraceptive.
Maltese: Sadanittant, uża kontraċettiv mhux ormonali.
English: • heavy menstrual periods; breast pain; pelvic pain
Maltese: • mestrwazzjoni eċċessiva; uġigħ fis-sider; uġigħ pelviku
English: • if you are very overweight (body mass index or BMI over 30 kg/m
Maltese: • jekk għandek ħafna piż żejjed (indiċi tal-piż tal-ġisem jew BMI (body mass index) aktar minn 30 kg/m2);
English: Note: Temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors.
Maltese: Nota: Immobilizzazzjoni temporanja inkluż ivvjaġġar bl-ajru ta' > 4 sigħat ukoll tista' tkun fattur ta' riskju għal VTE, b'mod partikolari f'nisa b'fatturi oħra ta' riskju.
English: • vaginal smell; discomfort in the vagina or vulva
Maltese: • riħa vaġinali; skonfort fil-vaġina jew fil-vulva
English: If you vomit or have severe diarrhoea within 3-4 hours of taking a yellow tablet, the reliability of Zoely is maintained.
Maltese: Jekk tirremetti jew ikollok dijarea qawwija fi żmien 3-4 sigħat minn meta tkun ħadt pillola safra, l-affidabilità ta' Zoely tinżamm.
English: • changes to menstrual periods (e.g. absence or irregularity)
Maltese: • tibdil fil-mestrwazzjoni (eż. assenti jew irregolari)
English: After stopping the combined pill, the increased risk gradually reduces.
Maltese: Wara li twaqqaf il-pillola kombinata, iż-żieda fir-riskju tonqos gradwalment.
English: • During clinical trials with the Hepatitis C virus (HCV) combination drug regimen ombitasvir/paritaprevir/ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medications such as CHCs.
Maltese: • Waqt provi kliniċi bl-iskeda ta' kombinazzjoni tal-mediċini ombitasvir/paritaprevir/ritonavir b'dasabuvir jew mingħajru għall-virus tal-Epatite C (HCV - Hepatitis C virus), żidiet fl-ALT ta' aktar minn 5 darbiet l-ogħla limitu tan-normal (ULN - upper limit of normal) kienu b'mod sinifikanti aktar frekwenti f'nisa li kienu qed jużaw mediċini li fihom ethinylestradiol bħal ma huma s-CHCs.
English: • if you have systemic lupus erythematosus (SLE - a disease affecting your natural defence system);
Maltese: • jekk għandek lupus eritematosus sistemiku (SLE - systemic lupus erythematosus, marda li taffettwa s-sistema ta' difiża naturali tiegħek);
English: Medicinal product interaction studies were not performed with Zoely, but two studies with rifampicin and ketoconazole, respectively, were performed with a higher dosed nomegestrol acetate-estradiol combination (nomegestrol acetate 3.75 mg + 1.5 mg estradiol) in post-menopausal women.
Maltese: Ma sarux studji dwar l-effett ta' mediċini jew ta' affarijiet oħra fuq l-effett farmaċewtiku ta' Zoely, iżda żewġ studji b'rifampicin u ketoconazole, rispettivament, twettqu b'doża ogħla ta' taħlita ta' nomegestrol acetate-estradiol (nomegestrol acetate 3.75 mg + 1.5 mg estradiol) f'nisa li diġà għaddew mill-menopawsa.
English: Tel: +34 91 114 34 87
Maltese: Tél/Tel: + 32 28 08 80 80
English: • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)
Maltese: • jekk għandek problema b'qalbek (disturb fil-valv, disturb fir-ritmu msejjaħ fibrillazzjoni tal atriju)
English: Zoely comes in blisters of 28 film-coated tablets (24 white active film-coated tablets and 4 yellow placebo film-coated tablets) packed in a ply carton.
Maltese: Zoely jiġi f'folji ta' 28 pillola miksija b'rita (24 pillola bojod attivi miksija b'rita u 4 pilloli sofor talplaċebo miksija b'rita) ippakkjati f'kartuna ikkorrugata.
English: Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate
Maltese: Nisa li qed jużaw pillola kontraċettiva kkombinata tal-ormoni li fiha levonorgestrel, norethisterone jew norgestimate
English: What is the risk of developing a blood clot?
Maltese: X'riskju hemm li tiżviluppa tagħqid tad-demm?
English: • Estradiol, the oestrogen in Zoely, is identical to the hormone produced by your ovaries during a menstrual cycle.
Maltese: • Estradiol, l-estrogen f'Zoely hu identiku għall-ormon li jiġi prodott fl-ovarji tiegħek waqt ċiklu mestrwali.
English: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, e.g., corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
Maltese: L-użu ta' sterojdi kontraċettivi jista' jinfluwenza r-riżultati ta' ċerti testijiet tal-laboratorju, li jinkludu l-parametri bijokimiċi tal-funzjoni tal-fwied, tat-tirojde, tal-funzjoni adrenali u tal-kliewi, il-livelli fil-plażma ta' proteini (li jġorru), eż., globulina li teħel mal-kortikosterojdi u frazzjonijiet ta' lipidi/lipoproteini, il-parametri tal-metaboliżmu tal-karboidrati u l-parametri tal-koagulazzjoni u fibrinolisi.
English: Zoely is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis (see section 4.3).
Maltese: Zoely huwa kontraindikat jekk mara jkollha fatturi ta' riskju multipli li jqegħduha f'riskju għoli ta' trombożi fil-vini (ara sezzjoni 4.3).
English: Your risk is higher:
Maltese: Fattur ta' riskju
English: There are no antidotes and further treatment should be symptomatic.
Maltese: M'hemm l-ebda antidoti speċifiċi, u kura addizzjonali għandha tkun sintomatika.
English: Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis; - sharp chest pain; - severe light headedness or dizziness; - rapid or irregular heartbeat.
Maltese: Sintomi ta' emboliżmu fil-pulmun (PE - pulmonary embolism) jistgħu jinkludu: - bidu f'daqqa ta' qtugħ ta' nifs mingħajr spjegazzjoni jew nifs mgħaġġel; - sogħla f'daqqa li tista' tkun assoċjata ma' sogħla bid-demm; - uġigħ qawwi fis-sider; - mejt qawwi jew sturdament; - qalb tħabbat tgħaġġel jew b'mod irregolari.
English: o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
Maltese: o Predispożizzjoni ereditarja jew akkwistata magħrufa għal tromboemboliżmu fl-arterji, bħal iperomosistejnimja u antikorpi kontra l-fosfolipidi (antikorpi kontra cardiolipin, antikoagulant tal-lupus).
English: Women should be advised to start between day 21 and 28 after delivery or second-trimester abortion.
Maltese: In-nisa għandhom jingħataw parir biex jibdew bejn jum 21 u 28 wara l-ħlas jew abort fit-tieni trimestru.
English: Zoely, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Maltese: Zoely, bħal kontraċettivi ormonali oħrajn ma jipproteġix kontra infezzjoni bl-HIV (AIDS) jew kwalunkwe marda oħra trasmessa sesswalment.
English: (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot.)
Maltese: (Ara sezzjoni 2 għal aktar informazzjoni dwar il-kondizzjonijiet li jżidu r-riskju ta' tagħqid tad-demm u s-sintomi ta' tagħqid tad-demm.)
English: • The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss.
Maltese: • Il-kundizzjonijiet li ġejjin kienu rrappurtati li jseħħu jew li jmorru għall-agħar kemm bit-tqala kif ukoll bl-użu ta' COC, iżda l-evidenza ta' rabta mal-użu ta' COC mhijiex konklużiva: suffejra u/jew ħakk marbut ma' kolestasi; formazzjoni ta' ġebel fil-marrara; porfirija; lupus eritematosus sistemiku; sindrome uremiku emolitiku; korea ta' Sydenham; herpes gestationis; telf ta' smigħ marbut ma' otosklerosi
English: How to store Zoely
Maltese: X'fih Zoely
English: The efficacy of COCs may be reduced in the event of e.g., missed tablets (see section 4.2), gastro-intestinal disturbances during active tablet-taking (see section 4.2) or use of concomitant medicinal products that decrease the plasma concentrations of nomegestrol acetate and/or estradiol (see section 4.5).
Maltese: L-effikaċja ta' COCs tista' titnaqqas fil-każ ta' eż., pilloli li ma jitteħdux (ara sezzjoni 4.2), disturbi gastrointestinali matul it-teħid tal-pilloli attivi (ara sezzjoni 4.2) jew użu ta' prodotti mediċinali li jittieħdu fl-istess ħin li jnaqqsu l-konċentrazzjonijiet ta' nomegestrol acetate u/jew estradiol filplażma (ara sezzjoni 4.5).
English: OTHER
Maltese: Oss
English: • The herbal product St. John's wort may also stop Zoely from working properly.
Maltese: John's wort jista' wkoll iwaqqaf Zoely milli jaħdem kif suppost.
English: (TIA)
Maltese: • ġuħ
English: Products containing oestrogens may induce or worsen symptoms of angioedema;
Maltese: Prodotti li fihom estroġeni jistgħu jikkaġunaw jew iħarrxu s-sintomi ta' anġjoedema.
English: Zoely 2.5 mg/1.5 mg film-coated tablets
Maltese: Zoely 2.5 mg/1.5 mg pilloli miksija b'rita
English: • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: • Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, nuqqas tal-lactase ta' Lapp jew assorbiment ħażin ta' glucose-galactose, m'għandhomx jieħdu dan il-prodott mediċinali.
English: Picture
Maltese: Deskrizzjoni
English: Allergic (hypersensitive) reactions have been reported in users of Zoely, but the frequency cannot be estimated from the available data.
Maltese: Reazzjonijiet allerġiċi (ipersensittività) ġew irrapportati f'utenti ta' Zoely, iżda l-frekwenza ma tistax tiġi stmata mid-dejta disponibbli.
English: Metabolism and nutrition disorders increased appetite, fluid retention decreased appetite
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni żieda fl-aptit, żamma ta' fluwidu nuqqas t'aptit
English: Symptoms of a myocardial infarction (MI) can include: - pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; - discomfort radiating to the back, jaw, throat, arm, stomach; - feeling of being full, having indigestion or choking; - sweating, nausea, vomiting or dizziness; - extreme weakness, anxiety, or shortness of breath; - rapid or irregular heartbeats.
Maltese: Sintomi ta' infart mijokardijaku (MI - myocardial infarction) jistgħu jinkludu: - uġigħ, skumdità, pressjoni, toqla, sensazzjoni ta' għafis jew tħossok mimlija fis-sider, fid driegħ jew taħt l-għadma tas-sider bejn il-kustilji; - skumdità li tinfirex għad-dahar, xedaq, gerżuma, driegħ, stonku; - tħossok mimlija, ikollok indiġestjoni jew tifga; - għaraq, nawsja, rimettar jew sturdament; - dgħufija, ansjetà, jew qtugħ ta' nifs estremi; - taħbit tal-qalb mgħaġġel jew irregolari.
English: These substances are represented mostly with anticonvulsants (e.g. carbamazepine, topiramate, phenytoin, phenobarbital, primidone, oxcarbazepine, felbamate); anti-infective drugs (e.g. rifampicin, rifabutin, griseofulvin); St. John's wort; bosentan and HIV or Hepatitis C virus (HCV) protease inhibitors (e.g. ritonavir, boceprevir, telaprevir) and non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz).
Maltese: John's wort; bosentan u inibituri tal-protease tal-HIV jew tal-virus tal-Epatite Ċ (HCV - Hepatitis C virus) (eż. ritonavir, boceprevir, telaprevir) u inibituri non-nukleoside tar-reverse transcriptase (eż. efavirenz).
English: • The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
Maltese: • L-użu ta' kwalunkwe kontraċettiv ikkombinat tal-ormoni (CHC - combined hormonal contraceptive) iżid ir-riskju ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism)
English: Each white active tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Maltese: Kull pillola fiha 2.5 mg ta' nomegestrol acetate (2.5 mg) u 1.5 mg ta' estradiol (bħala hemihydrate).
English: Changes generally remain within the normal laboratory range.
Maltese: It-tibdil ġeneralment jibqa' fil-medda normali tal-laboratorju.
English: • Crohn's disease, ulcerative colitis, and worsening of depression have been associated with COC use.
Maltese: • Il-marda ta' Crohn, kolite ulċerattiva, u depressjoni li tmur għall-agħar kienu assoċjati mal-użu ta' COC.
English: Symptoms of ATE
Maltese: Sintomi ta' ATE
English: • 7 days of uninterrupted ‘white active tablet'-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.
Maltese: • 7 ijiem mingħajr interruzzjoni ta' teħid ta' ‘pilloli bojod attivi' huma meħtieġa biex jinkiseb trażżin adegwat tal-assi-ipotalamiku-pitwitarju-ovarji.
English: The percentage of women using Zoely experiencing intracyclic bleeding after this adaptation period ranged from 15-20 %.
Maltese: Il-perċentwal ta' nisa li jużaw Zoely u li jkun qed ikollhom ħruġ ta' demm intraċikliku wara dan il-perjodu ta' adattament kien ivarja bejn 15-20 %.
English: • Presence or history of liver tumours (benign or malignant).
Maltese: • Il-preżenza jew storja medika ta' tumuri tal-fwied (beninni jew malinni).
English: • Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
Maltese: • Nisa b'ipertrigliċeridemija, jew bi storja medika fil-familja tal-istess kundizzjoni, jistgħu jkunu f'riskju miżjud ta' pankreatite meta jużaw COCs.
English: The pharmacokinetics of nomegestrol acetate (primary objective) after single oral dosing of Zoely in healthy postmenarcheal female adolescents and adult subjects were similar.
Maltese: Il-farmakokinetika ta' nomegestrol acetate (oġġettiv primarju) wara dożaġġ orali wieħed ta' Zoely f'nisa adolexxenti b'saħħithom wara li kellhom l-ewwel mestrwazzjoni u persuni adulti kienu simili.
English: • if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin - III deficiency, Factor V Leiden or antiphospholipid antibodies;
Maltese: • jekk taf li għandek disturb li jaffettwa t-tagħqid tad-demm tiegħek - pereżempju, defiċjenza talproteina Ċ, defiċjenza tal-proteina S, defiċjenza ta' antithrombin III, Fattur V Leiden jew antikorpi kontra l-fosfolipidi;
English: Concomitant administration of strong (e.g. ketoconazole, itraconazole, clarithromycin) or moderate (e.g. fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors may increase the serum concentrations of oestrogens or progestogens.
Maltese: L-għoti flimkien ma' inibituri qawwija (eż. ketoconazole, itraconazole, clarithromycin) jew moderati (eż. fluconazole, diltiazem, erythromycin) ta' CYP3A4 jista' jżid il-konċentrazzjonijiet tal-estroġeni jew tal-proġestoġeni fis-serum.
English: • The 4 yellow tablets are inactive tablets that do not contain hormones and are called placebo tablets.
Maltese: • L-4 pilloli sofor huma pilloli li mhumiex attivi li ma fihomx ormoni u huma msejħa pilloli tal-plaċebo.
English: Nervous system disorders headache, migraine cerebrovascular accident, transient ischaemic attack, disturbance in attention
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras, emigranja inċident ċerebrovaskulari attakk iskemiku temporanju, disturbi flattenzjoni
English: Tablet coat (white active film-coated tablets) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171) Macrogol 3350
Maltese: Kisja tal-pillola (pilloli bojod attivi miksija b'rita) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171)
English: • In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs.
Maltese: • F'każijiet rari, tumuri beninni tal-fwied, u f'każijiet iktar rari, tumuri malinni tal-fwied, kienu rrappurtati f'nisa li jużaw COCs.
English: Reproductive system and breast disorders abnormal withdrawal bleeding metrorrhagia, menorrhagia, breast pain, pelvic pain hypomenorrhoea, breast swelling, galactorrhoea, uterine spasm, premenstrual syndrome, breast mass, dyspareunia, vulvovaginal dryness vaginal odour, vulvovaginal discomfort
Maltese: Disturbi fis-sistema riproduttiva u fis-sider ħruġ anormali tad-demm meta tieqaf tieħu l-mediċina tnixxija anormali tad-demm mill ġuf, mestrwazzjoni esaġerata, uġigħ fis-sider, uġigħ pelviku mestrwazzjoni skarsa, nefħa fissider, tnixxija ta' ħalib mis-sider, spażmu tal-utru, sindrome premestrwali, massa fis-sider, uġigħ waqt l-att sesswali, nixfa vulvovaġinali riħa vaġinali, skonfort vulvovaġinali
English: • rapid or irregular heartbeat;
Maltese: • taħbit tal-qalb qawwi jew irregolari;
English: However, after single oral dosing, for the estradiol component (secondary objective), the exposure was 36 % lower in adolescents versus adult subjects.
Maltese: Madankollu, wara dożaġġ orali waħdieni, għall-komponent ta' estradiol (oġġettiv sekondarju), l espożizzjoni kienet 36 % iktar baxxa fl-adolexxenti kontra individwi adulti.
English: • severe hypertension
Maltese: GĦAMLA KWALITATTIVA
English: Zoely contains lactose.
Maltese: Zoely fih il-lactose.
English: The decision to prescribe Zoely should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Zoely compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Maltese: Meta tittieħed id-deċiżjoni li jiġi preskritt Zoely għandhom jitqiesu l-fatturi attwali ta' riskju tal-mara individwali, b'mod partikolari dawk ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism), u kif ir-riskju ta' VTE b'Zoely jikkumpara ma' dak ta' kontraċettivi kkombinati tal-ormoni (CHCscombined hormonal contraceptives) oħra (ara sezzjonijiet 4.3 u 4.4).
English: [In front of day labels intended for second blister:] Blister 2 [In front of day labels intended for third blister:] Blister 3
Maltese: [Quddiem it-tikketti tal-jum intenzjonati għat-tieni folja:] Folja 2 [Quddiem it-tikketti tal-jum intenzjonati għat-tielet folja:] Folja 3
English: White active film-coated tablets: Each film-coated tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Maltese: Kull pillola bajda attiva fiha 2.5 mg ta' nomegestrol acetate u 1.5 mg ta' estradiol (bħala hemihydrate).
English: • Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts).
Maltese: • Kanċer magħruf jew issuspettat influwenzat minn sterojdi tas-sess (eż. tal-organi ġenitali jew tas-sider).
English: Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g., transient ischaemic attack, stroke).
Maltese: Studji epidemjoloġiċi assoċjaw l-użu ta' CHCs ma żieda fir-riskju ta' tromboemboliżmu fl-arterji (infart mijokardijaku) jew ta' inċident ċerebrovaskulari (eż., attakk iskemiku temporanju, puplesija).
English: The clinical relevance of this result is unknown.
Maltese: Ir-rilevanza klinika ta'dan ir-riżultat mhux magħrufa.
English: Maximum serum concentrations of estradiol are about 90 pg/mL and are reached 6 h after dosing.
Maltese: Il-konċentrazzjonijiet massimi fis-serum ta' estradiol huma ta' madwar 90 pg/mL u jintlaħqu 6 sigħat wara d-dożaġġ.
English: Each pack starts with 24 white active tablets, followed by 4 yellow placebo tablets.
Maltese: Kull pakkett jibda b'24 pillola attiva bajda segwiti minn 4 pilloli sofor tal-plaċebo.