FrancophonIA/ELRC3.0 huggingface dataset:
English: The ECOG performance status at baseline was 0 or 1 in 89.7% of patients and 2 in 10.3% of patients.
Maltese: L-istat ta' ħila ta' ECOG fil-linja bażi kien ta' 0 jew 1 f'89.7% tal-pazjenti u 2 f'10.3% talpazjenti.
English: CNS-ORR in patients with measurable and non-measurable CNS metastases at baseline (IRC)
Maltese: CNS-ORR f'pazjenti b'metastasi fis-CNS li tista' titkejjel u li ma tistax titkejjel fil-linja bażi (IRC)
English: Proliferative zone extension in GI mucosa in both species was observed at exposures equal to or greater than 20-120% of the human AUC exposure at the recommended dose.
Maltese: Kienet osservata estensjoni proliferattiva taż-żona fil-mukuża GI fiż-żewġ speċi b'esponimenti daqs jew akbar minn 20-120% lesponiment fil-bniedem skont l-AUC bid-doża rakkomandata.
English: ● swelling caused by fluid build-up in the body (oedema)
Maltese: ● nefħa kkawżata minn akkumulazzjoni ta' fluwidu fil-ġisem (edima).
English: There are no available data on patients with extreme body weight (>130 kg) (see section 4.2).
Maltese: M'hemmx data disponibbli dwar pazjenti b'piż tal-ġisem għoli ħafna (>130 kg) (ara sezzjoni 4.2).
English: Median time to onset for constipation, nausea, diarrhea, and/or vomiting events across clinical trials (NP28761, NP28673, BO28984) was 21 days.
Maltese: Iż-żmien medjan għal bidu ta' avvenimenti ta' stitikezza, dardir, dijarea, u/jew rimettar fil-provi kliniċi kollha (NP28761, NP28673, BO28984) kien 21 jum.
English: Alecensa is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer' (‘NSCLC').
Maltese: Alecensa jintuża biex jittratta adulti li għandhom tip ta' kanċer tal-pulmun li jissejjaħ ‘kanċer talpulmun taċ-ċelluli mhux żgħar' (‘NSCLC - non-small cell lung cancer').
English: Target organs in both rat and monkey at clinically relevant exposures in the repeat-dose toxicology studies included, but were not limited to the erythroid system, gastrointestinal tract, and hepatobiliary system.
Maltese: Fl-istudji dwar l-effett tossiku minn dożi ripetuti b'esponimenti klinikament rilevanti organi fil-mira fil-firien kif ukoll fix-xadini kienu jinkludu, iżda ma kinux limitati għas-sistema eritrojda (erythroid), passaġġ gastro-intestinali, u sistema tal-fwied u tal-marrara.
English: ● nilotinib, a medicine used to treat certain types of cancer
Maltese: ● nilotinib, mediċina li tintuża biex tikkura ċerti tipi ta' kanċer
English: Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
Maltese: Alecensa bħala sustanza waħedha huwa indikat għat-trattament ta' pazjenti adulti b'NSCLC avanzat, pożittiv għal ALK li kienu ttrattati qabel b'crizotinib.
English: In the phase III clinical trial BO28984, Grade 3 or 4 bilirubin elevations occurred in 3.3% of patients receiving Alecensa versus no patient receiving crizotinib.
Maltese: Fil-prova klinika ta' fażi III BO28984, żidiet fil-bilirubina ta' Grad 3 jew 4 seħħew fi 3.3% tal-pazjenti li kienu qed jirċievu Alecensa kontra l-ebda pazjent li kien qed jirċievi crizotinib.
English: Results from the human mass balance study demonstrated that alectinib and M4 were the main circulating moieties in plasma with 76% of the total radioactivity in plasma.
Maltese: Riżultati mill-istudju tal-bilanċ tal-massa tal-bniedem wera li alectinib u M4 kienu l-moieties prinċipali li jiċċirkolaw fil-plażma b'76% tar-radjuattività totali filplażma.
English: ● nefazodone, a medicine used to treat depression
Maltese: ● nefazodone, mediċina li tintuża biex tikkura d-depressjoni
English: ● digoxin, a medicine used to treat heart problems
Maltese: ● digoxin, mediċina li tintuża biex tikkura problemi tal-qalb
English: This medicine contains 48 mg sodium (main component of cooking/table salt) per recommended daily dose (1200 mg).
Maltese: Din il-mediċina fiha 48 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir/li jintuża mal-ikel) f'kull doża rakkomandata ta' kuljum (1200 mg).
English: Table 1 Dose reduction schedule
Maltese: Tabella 1 Skeda ta' tnaqqis fid-doża
English: ‘glucose-galactose malabsorption'.
Maltese: Intolleranza għal-lactose
English: There are no available data on patients over 80 years of age.
Maltese: M'hemm lebda data disponibbli dwar pazjenti b'età 'l fuq minn 80 sena.
English: The co-primary endpoint was to evaluate the ORR as per central IRC assessment using RECIST 1.1 in patients with prior exposure of cytotoxic chemotherapy treatments.
Maltese: Il-punt finali koprimarju kien li tiġi evalwata l-ORR skont valutazzjoni ta' IRC ċentrali bl-użu ta' RECIST 1.1 f'pazjenti esposti minn qabel għal trattamenti b'kimoterapija ċitotossika.
English: In BO28984 (ALEX; N=152) the median duration of exposure to Alecensa was 17.9 months, whereas the median duration of exposure to crizotinib was 10.7 months.
Maltese: N=152) it-tul medjan ta' esponiment għal Alecensa kien ta' 17.9 xhur, filwaqt li t-tul medjan ta' esponiment għal crizotinib kien ta' 10.
English: What you need to know before you take Alecensa 3.
Maltese: X'għandek tkun taf qabel ma tieħu Alecensa 3.
English: The accumulation ratio for the twice-daily 600 mg regimen was approximately 6-fold.
Maltese: Ilproporzjon ta' akkumulazzjoni għall-kors ta' 600 mg darbtejn kuljum kien madwar 6 darbiet.
English: Concurrent elevations in ALT or AST greater than or equal 3 times the ULN and total bilirubin greater than or equal 2 times the ULN, with normal alkaline phosphatase, occurred in one patient treated in Alecensa clinical trials.
Maltese: avvenimenti ġeneralment seħħew matul l-ewwel 3 xhur ta' trattament, normalment kienu temporanji ul-biċċa l-kbira għaddew wara bidla fid-doża.
English: A total of 138 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Maltese: II tal-istudju kienu inklużi total ta' 138 pazjent li rċevew Alecensa mill-ħalq, bid-doża rakkomandata ta' 600 mg darbtejn kuljum.
English: As alectinib inhibits P-gp, it is not expected that co-medication with P-gp inhibitors has a relevant effect on M4 exposure.
Maltese: Peress li alectinib jinibixxi P-gp, mhux mistenni li medikazzjoni fl-istess waqt b'inibituri ta' P-gp jkollha effett rilevanti fuq l-esponiment għal M4.
English: Number of patients with event n (%) Median (months) [95% CI]
Maltese: Numru ta' pazjenti b'avveniment n (%) Medjan (xhur)
English: White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body.
Maltese: Kapsula iebsa bajda b'tul ta' 19.2 mm, b'“ALE” stampat b'linka sewda fuq l-għatu u “150 mg” stampat b'linka sewda fuq il-parti l-oħra tal-kapsula.
English: ● Fainting, dizziness and low blood pressure (potential signs of slow heart beat)
Maltese: ● Ħass ħażin, sturdament u pressjoni baxxa (sinjali potenzjali ta' rata ta' taħbit tal-qalb baxxa)
English: Vomiting
Maltese: Teratoġeniċità
English: Concurrent elevations in ALT or AST greater than or equal to three times the ULN and total bilirubin greater than or equal to two times the ULN, with normal alkaline phosphatase, occurred in one patient (0.2%) treated in Alecensa clinical trials.
Maltese: Żidiet fl-istess waqt fl-ALT jew AST ta' aktar minn jew ugwali għal 3 darbiet l-ULN u fil-bilirubina totali ta' aktar minn jew ugwali għal darbtejn l-ULN, b'alkaline phosphatase normali, seħħew f'pazjent wieħed (0.2%) ittrattat fil-provi kliniċi b'Alecensa.
English: Median time to Grade 3 CPK elevation was 14 days across trials (NP28761, NP28673, BO28984).
Maltese: II bi grupp wieħed (NP28761, NP28673).
English: A total of 87 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Maltese: II tal-istudju kienu inklużi total ta' 87 pazjent li rċevew Alecensa mill-ħalq, bid-doża rakkomandata ta' 600 mg darbtejn kuljum.
English: A mild hypotensive effect has been observed in monkeys at around clinically relevant exposures.
Maltese: Kien osservat effett ipotensiv ħafif fix-xadini b'esponimenti fil-firxa klinikament rilevanti.
English: In pregnant rabbits, alectinib caused embryo-foetal loss, small fetuses and increased incidence of skeletal variations at exposures 2.9-fold of the human AUC exposure at the recommended dose.
Maltese: Fi fniek tqal, alectinib ikkawża telf tal-embrijuni u l-feti, feti żgħar u żieda fl-inċidenza ta' varjazzjonijiet skeletriċi b'esponimenti 2.9 darbiet l-esponiment filbniedem skont l-AUC bid-doża rakkomandata.
English: Grade 4 (life-threatening consequences, urgent intervention indicated)
Maltese: Bradikardijaa ta' Grad 4 (konsegwenzi ta' periklu għall-ħajja, intervent urġenti indikat)
English: What Alecensa is Alecensa is a cancer medicine that contains the active substance alectinib.
Maltese: X'inhu Alecensa Alecensa huwa mediċina għall-kanċer li fih is-sustanza attiva alectinib.
English: Negligible amounts of alectinib and the active metabolite M4 are excreted unchanged in urine (< 0.2%
Maltese: Ammonti negliġibbli ta' alectinib u tal-metabolit attiv M4 huma mneħħija mhux mibdula fl-awrina (< 0.2% tad-doża).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The pharmacokinetics of alectinib has not been studied in patients with severe renal impairment.
Maltese: Il-farmakokinetika ta' alectinib ma ġietx studjata f'pazjenti b'indeboliment sever tal-kliewi.
English: Alecensa should be immediately interrupted in patients diagnosed with ILD/pneumonitis and should be permanently discontinued if no other potential causes of ILD/pneumonitis have been identified (see section 4.2).
Maltese: Alecensa għandu jiġi interrott immedjatament f'pazjenti dijanjostikati b'ILD/pulmonite u għandu jitwaqqaf għal kollox jekk ma tiġi identifikata l-ebda kawża potenzjali oħra ta' ILD/pulmonite (ara sezzjoni 4.2).
English: The pharmacokinetic parameters for alectinib and its major active metabolite (M4) have been characterised in ALK-positive NSCLC patients and healthy subjects.
Maltese: Il-parametri farmakokinetiċi għal alectinib u l-metabolit attiv maġġuri tiegħu (M4) kienu kkaratterizzati f'pazjenti b'NSCLC pożittiv għal ALK u f'individwi f'saħħithom.
English: In the pivotal Alecensa clinical trials it was reported that three patients with Grade 3-4 AST/ALT elevations had drug induced liver injury.
Maltese: Fil-provi kliniċi pivotali b'Alecensa, kien irrappurtat li tliet pazjenti b'żidiet ta' AST/ALT ta' Grad 3-4 kellhom ħsara fil-fwied ikkawżata mill-mediċina.
English: Although PK simulations for Alecensa do not indicate a low exposure in patients with extreme body weight (i.e. >130 kg), alectinib is widely distributed and clinical studies for alectinib enrolled patients within a range of body weights of 36.9−123 kg.
Maltese: Għalkemm simulazzjonijiet tal-PK għal Alecensa ma jindikawx esponiment baxx f'pazjenti b'piż talġisem għoli ħafna (jiġifieri >130 kg), alectinib huwa distribwit ħafna u studji kliniċi għal alectinib rreġistraw pazjenti fi ħdan firxa ta' piżijiet tal-ġisem ta' 36.9−123 kg.
English: However, since alectinib elimination via the kidney is negligible, no dose adjustment is required in patients with severe renal impairment (see section 5.2).
Maltese: Madankollu, peress li l-eliminazzjoni ta' alectinib mill-kliewi hija negliġibbli, mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 5.2).
English: Among the patients included in the study, 26% of the patients had previously progressed on crizotinib treatment only, and 74% had previously progressed on crizotinib and at least one chemotherapy treatment.
Maltese: Fost il-pazjenti nklużi fl-istudju, 26% tal-pazjenti kellhom progressjoni preċedenti waqt trattament b'crizotinib biss, u 74% kellhom progressjoni preċedenti waqt trattament b'crizotinib u mill-inqas trattament wieħed ta' kimoterapija.
English: Temporarily withhold until recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
Maltese: Waqqaf b'mod temporanju sakemm iseħħ irkupru għal bradikardija (mingħajr sintomi) ta' ≤ Grad 1 jew għal rata ta' tħabbit tal-qalb ta' ≥ 60 bpm.
English: Among patients included in the study, 20% of the patients had previously progressed on crizotinib treatment only, and 80% had previously progressed on crizotinib and at least one chemotherapy treatment.
Maltese: Fost il-pazjenti nklużi fl-istudju, 20% tal-pazjenti kellhom progressjoni preċedenti waqt trattament b'crizotinib biss, u 80% kellhom progressjoni preċedenti waqt trattament b'crizotinib u mill-inqas trattament wieħed ta' kimoterapija.
English: In vitro metabolism studies showed that CYP3A4 is the main CYP isozyme mediating alectinib and its major metabolite M4 metabolism, and is estimated to contribute 40-50% of alectinib metabolism.
Maltese: Studji in vitro dwar il-metaboliżmu wrew li CYP3A4 hija l-isoenzima CYP prinċipali li timmedja lmetaboliżmu ta' alectinib u l-metabolit prinċipali tiegħu M4, u huwa stmat li tikkontribwixxi għal 4050% tal-metaboliżmu ta' alectinib.
English: Female patients of child-bearing potential receiving Alecensa must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa.
Maltese: Pazjenti nisa li jistgħu joħorġu tqal li jirċievu Alecensa għandhom jużaw metodi ta' kontraċezzjoni effettivi ħafna waqt it-trattament u għal mill-inqas 3 xhur wara l-aħħar doża ta'Alecensa.
English: Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inducers.
Maltese: Abbażi tal-effetti fuq l-esponiment ikkombinat għal alectinib u M4, mhux meħtieġa aġġustamenti fid-doża meta Alecensa jingħata flimkien ma' indutturi ta' CYP3A.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità
English: Your risk is
Maltese: Fattur ta' riskju
English: IOA contains 17β-estradiol.
Maltese: IOA fih 17β-estradiol.
English: Organon (Ireland) Ltd. Drynam Road Swords
Maltese: Organon (Ireland) Limited Drynam Road Swords
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' Novembru 2011
English: • if you have (had) a benign or malignant tumour in the liver;
Maltese: mestrwazzjoni esaġerata, uġigħ fis-sider, uġigħ pelviku skarsa, nefħa fis sider, tnixxija ta'
English: Comment
Maltese: Co.
English: If you take more IOA than you should (overdose) If you vomit or have severe diarrhoea If you want to change the starting day of your period If you have missed one or more periods
Maltese: Jekk l-att sesswali jkun sar fis-7 ijiem ta' qabel, il-possibbiltà ta' tqala għandha tiġi kkunsidrata.
English: - epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine,
Maltese: - epilessija (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
English: The estrogen contained in IOA is 17β-estradiol, a natural estrogen identical to the endogenous human
Maltese: L-estroġenu li hemm f'IOA hu 17β-estradiol, estroġenu naturali identiku għal 17β-estradiol endoġenu uman.
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 yellow (E172) u iron oxide black (E172)
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: 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: The IOA 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' IOA fiha 28 pillola: 24 pillola bajda bis-sustanzi attivi (numru 1-24) u 4 pilloli sofor mingħajr sustanzi attivi (numru 25-28).
English: Magnesium stearate (E572) Silica, colloidal anhydrous
Maltese: Silica, colloidal anhydrous
English: • Nomegestrol acetate, the progestogen in IOA, is derived from the hormone progesterone.
Maltese: • Nomegestrol acetate, il-progestogen f'IOA, jinkiseb mill-ormon progesterone.
English: These are nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Maltese: Dawn huma nomegestrol acetate (progestogen) u estradiol
English: Lactose monohydrate (see section 2 ‘IOA contains lactose'), cellulose microcrystalline (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and silica colloidal anhydrous Tablet coating (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 ‘IOA fih lactose'), cellulose microcrystalline (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) u silica colloidal anhydrous Kisja tal-pillola (pilloli bojod attivi miksija b'rita):
English: Estradiol circulates in the blood bound to SHBG (37 %) and to albumin (61 %), while only approximately
Maltese: Estradiol jiċċirkola fid-demm imwaħħal ma' SHBG (37 %) u mal-albumina (61 %), filwaqt li madwar 1-2 % biss ikun mhux imwaħħal.
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 IOA 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'IOA u iktar minn 1,000 mara b'drospirenone 3 mg - ethinylestradiol 30 μg (kors ta' 21/7).
English: • With the use of the higher-dosed COCs (50 µg 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: • Contraceptive pills that contain two different hormones, like IOA, are called ‘combined pills'.
Maltese: • Pilloli kontraċettivi li fihom żewġ ormoni differenti, bħal IOA, huma msejħa ‘pilloli kombinati'.
English: IOA 2.5 mg/1.5 mg film-coated tablets Nomegestrol acetate/estradiol
Maltese: IOA 2.5 mg/1.5 mg pilloli miksija b'rita Nomegestrol acetate/estradiol
English: Adverse reaction in MedDRA Term1
Maltese: Reazzjoni avversa fit-Terminu MedDRA1
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Interazzjonijiet
English: Obesity (body mass index over 30 kg/m²)
Maltese: 30 kg/m²)
English: Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 and talc (E553b) Tablet coating (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: The elimination half-life (t1/2) is 46 h (ranging from 28-83 h) at steady state.
Maltese: Eliminazzjoni Il-half-life tal-eliminazzjoni (t1/2) hi ta' 46 siegħa (li tvarja minn 28-83 siegħa) fl-istat fiss.
English: Nomegestrol acetate has a strong affinity for the human progesterone receptor and has an anti-gonadotropic activity, a progesterone receptor-mediated anti-estrogenic activity, a moderate anti-androgenic activity, and is devoid of any estrogenic, androgenic, glucocorticoid or
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,
English: - HIV infections (e.g. ritonavir, nevirapine, nelfinavir, efavirenz); - other infectious diseases (e.g. griseofulvin); - high blood pressure in the blood vessels in the lungs (bosentan).
Maltese: - infezzjonijiet bl-HIV (eż. ritonavir, nevirapine, nelfinavir, efavirenz); - mard infettiv ieħor (eż. griseofulvin).
English: Also HIV protease inhibitors with an inducing potential (e.g. ritonavir and nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine and efavirenz), may affect hepatic metabolism.
Maltese: Flimkien ma' dan, impedituri ta' HIV protease b'potenzjal li jinduċu (eż. ritonavir u nelfinavir) u inibituri non-nukleoside tar-reverse transcriptase (eż. nevirapine u efavirenz), jistgħu jaffettwaw il-metaboliżmu fil-fwied.
English: Table: Risk factors for ATE
Maltese: Tabella: Fatturi ta' riskju għal VTE
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) Fil-prova klinika li saret b'IOA fl-Istati Uniti, l-Indiċi Pearl li ġejjin għall-klassi ta' età 18-35 sena ġew ikkalkulati:
English: Tablet coating (white active film-coated tablets) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171)
Maltese: Kisja tal-pillola (pilloli bojod attivi miksija b'rita) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171)
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 f'sezzjoni 4.4.
English: IOA is indicated for the prevention of pregnancy.
Maltese: IOA hu indikat għall-prevenzjoni tat-tqala.
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'
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
English: The percentage of women using IOA experiencing intracyclic bleeding after this adaptation period ranged from 15-20 %.
Maltese: Il-perċentwal ta' nisa li jużaw IOA u li jkun qed ikollhom ħruġ ta' demm intraċikliku wara dan il-perjodu ta' adattament kien ivarja bejn 15-20 %.
English: PVC/aluminium blister containing 28 film-coated tablets (24 white film-coated tablets and 4 yellow Pack sizes: 28 and 84 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: 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.