FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose-linearity was observed in the range 0.625-5 mg (assessed in fertile and post-menopausal
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: • if you have epilepsy (see in section 2 ‘Other medicines and IOA');
Maltese: • jekk għandek epilessija (ara f'sezzjoni 2 ‘Mediċini oħra u IOA');
English: Nomegestrol acetate and its hydroxylated metabolites undergo extensive phase 2 metabolism to form glucuronide- and sulphate conjugates.
Maltese: Nomegestrol acetate u l-metaboliti idrossilati tiegħu jgħaddu minn metaboliżmu estensiv ta' fażi 2 biex jiffurmaw konjugati ta' glucuronide u sulphate.
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
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.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and estrogens, fixed combinations, ATC code: G03AA14.
Maltese: Ormoni tas-sess u modulaturi tas-sistema ġenitali, proġestoġeni u estroġeni, kumbinazzjonijiet fissi, Kodiċi ATC:
English: NAME OF THE MEDICINAL PRODUCT IOA 2.5 mg/1.5 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI IOA 2.5 mg/1.5 mg pilloli miksija b'rita
English: Interactions
Maltese: Linearità
English: 28 % of the women experienced absence of withdrawal bleeding in at least one of the cycles 2, 3 and 4, associated with higher occurrences of absence of withdrawal bleeding in the later cycles of use, ranging from 51 % to 62 %.
Maltese: demm meta waqfu jieħdu l-mediċina f'mill-inqas wieħed miċ-ċikli 2, 3 u 4, assoċjat ma' okkorrenzi ogħla ta' assenza ta' ħruġ ta' demm mal-waqfien tal-mediċina fiċ-ċikli tal-użu li ġew wara, li jvarjaw minn 51 % sa 62 %.
English: Adverse reaction in MedDRA Term1 Very common Common
Maltese: Reazzjoni avversa fit-Terminu MedDRA1 Komuni
English: Each white active 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: IOA is a contraceptive pill that is used to prevent pregnancy.
Maltese: IOA hu pillola kontraċettiva li tintuża biex tiġi evitata t-tqala.
English: o Known hereditary or acquired predisposition for venous thromboembolism, such as APCresistance (including Factor V Leiden), antithrombin-III-deficiency, protein C 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,
English: Nomegestrol acetate
Maltese: Popolazzjonijiet speċjali
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
English: IOA contains lactose.
Maltese: bajda addizzjonali minn pakkett ieħor.
English: Available pharmacokinetic
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Obesity (body mass index over 30 kg/m2)
Maltese: 30kg/m2);
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: [Numru tal-jum għal kull pillola individwali:] Ibda,2, ….28
English: • Presence or risk of venous thromboembolism (VTE) o Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]).
Maltese: • Il-preżenza jew ir-riskju ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism) o Tromboemboliżmu fil-vini - VTE attwali (fuq mediċini kontra l-koagulazzjoni taddemm) jew storja ta' VTE (eż. trombożi fil-vini tal-fond [DVT - deep venous thrombosis] jew emboliżmu fil-pulmun [PE - pulmonary embolism]).
English: The decision to prescribe IOA should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with IOA compares with other CHCs (see sections 4.3 and 4.4).
Maltese: IOA 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'IOA jikkumpara ma' dak ta' CHCs oħra (ara sezzjonijiet 4.3 u 4.4).
English: Oxidation of estrone and estradiol involves cytochrome P450 enzymes, mainly CYP1A2, CYP1A2 (extra hepatic), CYP3A4, CYP3A5, and CYP1B1 and CYP2C9.
Maltese: Hemm ekwilibriju dinamiku bejn estradiol, estrone u estrone-sulfate minħabba d-diversi attivitajiet enzimatiċi li jinkludu estradiol-dehydrogenases, sulfotransferases u aryl sulfatases. Lossidazzjoni ta' estrone u estradiol tinvolvi l-enzimi ta' ċitokrom P450, primarjament CYP1A2, CYP1A2 (ekstra epatiku), CYP3A4, CYP3A5, u CYP1B1 u CYP2C9.
English: In the IOA 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: 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: • if you have systemic lupus erythematosus (SLE - a disease affecting your natural defense system);
Maltese: • jekk għandek lupus eritematosus sistemiku (SLE - systemic lupus erythematosus, marda li taffettwa s-sistema ta' difiża naturali tiegħek);
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
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: The increased risk of VTE during the postpartum period should be considered when re-starting IOA (see section 4.2 and 4.4).
Maltese: .3) Għandu jitqies ir-riskju ta' VTE waqt il-perjodu ta' wara t-twelid meta IOA jinbeda mill-ġdid (ara sezzjonijiet 4.2 u 4.4).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: The clinical relevance of this result is unknown.
Maltese: Ir-rilevanza klinika ta'
English: If she is more than 12 hours late in taking any active tablet, contraceptive protection may be reduced.
Maltese: Jekk il-mara tkun inqas minn 12-il siegħa tard fit-teħid ta' kwalunkwe pillola attiva, il-protezzjoni kontraċettiva ma titnaqqasx.
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: • Estradiol, the oestrogen in IOA, is identical to the hormone produced by your ovaries during a
Maltese: • Estradiol, l-estrogen f'IOA hu identiku għall-ormon li jiġi prodott fl-ovarji tiegħek waqt ċiklu mestrwali.
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
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: The efficacy of COCs may be reduced in the event of e.g., missed tablets (see section 4.2), gastrointestinal disturbances during active tablet-taking (see section 4.2) or use of concomitant medicinal
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 (ara sezzjoni 4.5).
English: • It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 61 will
Maltese: • Huwa stmat li minn 10,000 mara li jużaw CHC li fih levonorgestrel madwar 61 jiżviluppaw VTE f'sena waħda.
English: Day label sheet
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Merck Sharp & Dohme, inovativna zdravila d.o.o.
Maltese: Merck Sharp & Dohme d.o.o.
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'
English: • Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the
Maltese: • Kanċer magħruf jew issuspettat influwenzat minn sterojdi tas-sess (eż. tal-organi ġenitali jew tas-sider).
English: Medicinal product subject to medical prescription.
Maltese: Kondizzjonijiet mediċi oħra assoċjati ma'
English: With hepatic enzyme-inducing substances, a barrier method should be used during the time of concomitant medicinal product administration and for 28 days after their discontinuation.
Maltese: Ma' sustanzi li jinduċu l-enzimi tal-fwied, għandu jintuża metodu ta' kontraċezzjoni mekkanika waqt l-għoti fl-istess ħin tal-prodott mediċinali u għal 28 jum wara t-twaqqif tagħhom.
English: IOA comes in 1 or 3 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: IOA jiġi f'folji ta' 1 jew 3 ta' 28 pillola miksija b'rita (24 pillola bojod attivi miksija b'rita u 4 pilloli sofor tal-plaċebo miksija b'rita) ippakkjati f'kartuna ply.
English: Rare increased appetite, fluid retention decreased appetite increased libido cerebrovascular accident, transient ischaemic attack, disturbance in attention
Maltese: emigranja inċident ċerebrovaskulari attakk iskemiku temporanju, disturbi flattenzjoni
English: Description of selected adverse reactions
Maltese: avvenimenti vaskulari avversi
English: If you vomit or have severe diarrhoea within 3-4 hours of taking a yellow tablet, the reliability of IOA is maintained.
Maltese: Jekk tirremetti jew ikollok dijarea qawwija fi żmien 3-4 sigħat minn meta tkun ħadt pillola safra, l-affidabilità ta' IOA tinżamm.
English: Hepatobiliary disorders cholelithiasis, cholecystitis hyperhydrosis, alopecia, pruritus, dry skin, seborrhea chloasma, hypertrichosis sensation of heaviness hypomenorrhoea, breast swelling, galactorrhoea, uterine spasm, premenstrual syndrome, breast mass, dyspareunia, vulvovaginal dryness vaginal odour, vulvovaginal discomfort irritability, oedema hunger weight increased hepatic enzyme increased
Maltese: - 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: IOA is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis (see section 4.3).
Maltese: IOA huwa kontraindikat jekk mara jkollha fatturi ta' riskju multipli li jqegħduha f'riskju għoli ta' trombożi fil-vini (ara sezzjoni 4.3).
English: The risk of reduced reliability is imminent because of the forthcoming placebo tablet phase.
Maltese: Ir-riskju ta' tnaqqis fl-affidabilità hu imminenti minħabba l-fażi li tkun ġejja tal-pillola tal-plaċebo.
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: • 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 o Cerebrovascular disease - current stroke, history of stroke or prodromal condition o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies,
Maltese: o Tromboemboliżmu fl-arterji - tromboemboliżmu attwali fl-arterji, storja ta' tromboemboliżmu fl-arterji (eż. infart mijokardijaku) jew kondizzjoni prodromika (eż. anġina pectoris).
English: • if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
Maltese: • jekk għandek il-marda ta' Crohn jew kolite ulċerattiva (mard infjammatorju kroniku tal imsaren);
English: Tumours
Maltese: • fwawar
English: Nomegestrol
Maltese: Pożoloġija
English: MSD Polska Sp.z o.o.
Maltese: Ελλάδα MSD Α.Φ.Β.Ε.Ε.
English: • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial
Maltese: • jekk għandek problema b'qalbek (disturb fil-valv, disturb fir-ritmu msejjaħ fibrillazzjoni tal atriju)
English: Deep vein thrombosis
Maltese: Trombożi fil-vini tal
English: Symptoms of a cerebrovascular accident can include: - sudden numbness or weakness of the face, arm or leg, especially on one side of the body; - sudden trouble walking, dizziness, loss of balance or coordination; - sudden confusion, trouble speaking or understanding; - sudden trouble seeing in one or both eyes; - sudden, severe or prolonged headache with no known cause; - loss of consciousness or fainting with or without seizure.
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;
English: See also ‘General Notes' in section 2
Maltese: Ara ‘Kontroll taċ-ċiklu' f'sezzjoni
English: • if you are going to use other medicines (see also in section 2 ‘Other medicines and IOA');
Maltese: • jekk tkun se tuża mediċini oħrajn (ara wkoll f'sezzjoni 2 ‘Mediċini oħra u IOA');
English: The woman should start with IOA preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
Maltese: Il-mara għandha tibda b'IOA preferibbilment fil-jum wara l-aħħar pillola attiva (l-aħħar pillola li jkun fiha s-sustanzi attivi) tas-COC li kienet tieħu qabel, iżda mhux aktar tard mill-jum wara l-intervall normali mingħajr pillola jew pillola tal-plaċebo tas-COC li kienet tieħu qabel.
English: Each time you start a new blister of IOA, take the number 1 white active tablet in the left-hand top corner (see ‘Start').
Maltese: Kull meta tibda folja ġdida ta' IOA, ħu l-pillola bajda attiva numru 1 fil-kantuniera ta' fuq tan-naħa tax-xellug (ara ‘Ibda').
English: Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
Maltese: Merck Sharp & Dohme OÜ Tel: + 372 6144 200 msdeesti@merck.com
English: It is unknown whether the amount of estradiol in IOA is sufficient to maintain adequate levels of estradiol in adolescents, especially for bone mass accrual (see section 5.2).
Maltese: Mhux magħruf jekk l-ammont ta' estradiol f'IOA hux biżżejjed biex iżomm livelli adegwati ta' estradiol fl-adolexxenti, speċjalment għall-akkumulazzjoni tal-piż tal-għadam (ara sezzjoni 5.2).
English: Retinal vein thrombosis (blood clot in the eye)
Maltese: Sistema Intra Uterina (IUS) medikata bl-ormoni
English: Hepatic impairment
Maltese: Sintomi ta' ATE
English: Changing from a progestogen-only-method (minipill, implant, injectable) or from a hormone-medicated Intra Uterine System (IUS)
Maltese: Meta tibdel minn kontraċettiv li fih progestogen biss li jista' jiġi injettat, impjant jew sistema intrauterina medikata bl-ormoni (IUS)
English: IOA, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any
Maltese: IOA, bħal kontraċettivi ormonali oħrajn ma jipproteġix kontra infezzjoni bl-HIV (AIDS) jew kwalunkwe marda oħra trasmessa sesswalment.
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) meta mqabbel ma' meta ma jintużawx.
English: • if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack ) or transient ischaemic attack (TIA - temporary stroke
Maltese: o Mard ċerebrovaskulari - puplesija attwali, storja ta' puplesija jew kondizzjoni prodromika (eż. attakk iskemiku temporanju, TIA - transient ischaemic attack).
English: Tel: + 386 1 5204201 msd_slovenia@merck.com
Maltese: Tel: + 385 1 6611 333 croatia_info@merck.com
English: • if you smoke.
Maltese: • nuqqas ta' aptit
English: Women over 35 who continue to smoke should be strongly advised to use a different method of contraception.
Maltese: Nisa li għandhom aktar minn 35 sena li jkomplu jpejpu għandhom jiġu mwissija biex jużaw metodu ta' kontraċezzjoni differenti.
English: If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Maltese: Jekk il-bilanċ tal-benefiċċji u r-riskji jitqies li huwa negattiv, CHC m'għandux jiġi preskritt (ara sezzjoni 4.3).
English: Eye disorders contact lens intolerance/dry eye
Maltese: • għajnejn xotti; intolleranza għal contact lenses • ħalq xott
English: IOA is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3).
Maltese: IOA huwa kontraindikat jekk mara jkollha fattur ta' riskju wieħed serju jew fatturi ta' riskju multipli għal ATE li jqegħduha f'riskju għoli ta' trombożi fl-arterji (ara sezzjoni 4.3).
English: A prospective observational study to assess in particular the risk of Venous thromboembolic events (VTE) and ATE in nomegestrol/estradiol users compared with the VTE risk in users of combined oral contraceptives containing levonorgestrel.
Maltese: Apparti r-reazzjonijiet avversi msemmija hawn fuq, reazzjonijiet ta' sensittività eċċessiva ġew irrapportati f'utenti ta' IOA (frekwenza mhux magħrufa).
English: Nomegestrol acetate is a highly selective progestogen derived from the naturally occurring steroid hormone, progesterone.
Maltese: Nomegestrol acetate hu progestogen selettiv ħafna miksub minn progesterone, l-ormon tal-isterojde li jseħħ b'mod naturali.
English: The elimination half-life Nomegestrol acetate is excreted via urine and feces.
Maltese: Il-half-life tal-eliminazzjoni tal-metaboliti ma ġietx stabbilita.
English: • Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using low-dose COCs (containing < 0.05 mg ethinylestradiol).
Maltese: • Minkejja li COCs jista' jkollhom effett fuq ir-reżistenza periferika għall-insulina u tolleranza tal-glucose, m'hemm l-ebda evidenza għal ħtieġa li tibdel il-kors terapewtiku f'nisa dijabetiċi li jużaw COCs b'doża baxxa (li fihom (< 0.05 mg ta' ethinylestradiol).
English: • if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50).
Maltese: • jekk membru tal-familja immedjata tiegħek kellu attakk tal-qalb jew puplesija ta' età żgħira (anqas minn madwar 50 sena).
English: Medicinal product interaction studies were not performed with IOA, 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: nomegestrol acetate-estradiol (nomegestrol acetate 3.75 mg + 1.5 mg estradiol) f'nisa li diġà għaddew mill-menopawsa.
English: Tablet core (white active and yellow placebo film-coated tablets)
Maltese: Il-komposti attivi ormonali fil-pillola jista'
English: • if you are allergic to estradiol or nomegestrol acetate, or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġika għal estradiol jew għal nomegestrol acetate, jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: For more detailed information on the different risks from taking combined hormonal contraceptives, please see section 2, “What you need to know before you use IOA”.
Maltese: Għal informazzjoni f'aktar dettall dwar ir-riskji differenti mit-teħid ta' kontraċettivi kkombinati tal-ormoni, jekk jogħġbok ara sezzjoni 2, “X'għandek tkun taf qabel ma tuża IOA”.
English: • if you are less than 12 hours late in taking a tablet, the reliability of the pill is maintained.
Maltese: • jekk ikunu għaddew inqas minn 12-il siegħa minn meta suppost tkun ħadt pillola, l-affidabilità tal-pillola tinżamm.
English: All data presented below are based upon epidemiological data obtained with CHCs containing ethinylestradiol.
Maltese: Id-dejta kollha ppreżentata hawn taħt hi bbażata fuq dejta epidemjoloġika miksuba b'CHCs li fihom ethinylestradiol.
English: 4.2 Posology and method of administration
Maltese: 4.3 Kontraindikazzjonijiet
English: Due to metabolism and enterohepatic circulation, a large circulating pool of estrogen sulfates and glucuronides is present.
Maltese: Minħabba l-metaboliżmu u ċ-ċirkolazzjoni enteroepatika, ikun hemm ammont kbir ta' sulfates tal-estroġenu u glucuronides li jkunu jiċċirkolaw.
English: The decision to use any product other than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
Maltese: Ir-riskju ta' tagħqid ta' demm b'IOA huwa żgħir iżda xi kondizzjonijiet iżidu r-riskju.
English: 3 x 28 tablets
Maltese: Daqs tal-pakkett flixkun (HDPE) 28 pillola flixkun (HDPE) 3 x 28 pillola
English: ATC code: A10A B01.
Maltese: A10A B01.
English: Date of latest renewal: 18 September 2007
Maltese: Data ta' l-a ar ti did: 18 ta' Settembru 2007
English: Vision problems.
Maltese: Problemi tal-vista.
English: Metabolism
Maltese: Metaboli mu
English: Novo Allé, DK-2880 Bagsværd, Denmark
Maltese: Novo Allé, DK-2880 Bagsværd, Id-Danimarka
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervu a