FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of RoActemra were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg RoActemra every 4 weeks for 24 weeks or with 162 mg RoActemra given subcutaneously either once a week or every other week for 24 weeks.
Maltese: Il-farmakokinetika ta' RoActemra ġiet iddeterminata bl-użu ta' analiżi tal-farmakokinetika talpopolazzjoni minn tagħrif miġbur minn 3552 pazjent b'RA ttrattati b'infużjoni ta' siegħa ta' 4 jew 8 mg/kg RoActemra kull erba' ġimgħat għal 24 ġimgħa jew b'162 mg RoActemra mogħtija taħt ilġilda darba kull ġimgħa jew darba kull ġimagħtejn għal 24 ġimgħa.
English: The recommended posology in patients above 2 years of age is 8 mg/kg once every 4 weeks in patients weighing greater than or equal to 30 kg or 10 mg/kg once every 4 weeks in patients weighing less than 30 kg.
Maltese: Il-pożoloġija rrakkomandata f'pazjenti minn sentejn 'il fuq hija ta' 8 mg/kg darba kull 4 ġimgħat f'pazjenti li jiżnu 30 kg jew aktar jew 10 mg/kg darba kull 4 ġimgħat f'pazjenti li jiżnu inqas minn 30 kg.
English: 0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle.
Maltese: 0.9 mL ta' soluzzjoni f'siringa mimlija għal lest (ħġieġ tip I) b'labra moħbija.
English: For recommended modifications, including RoActemra discontinuation, based on transaminases levels see section 4.2.
Maltese: Għallmodifikazzjonijiet rakkomandati, inkluż it-twaqqif ta' RoActemra, ibbażati fuq il-livelli ta' tansaminases ara sezzjoni 4.2.
English: RoActemra versus adalimumab in monotherapy
Maltese: RoActemra jintuża biex jittratta:
English: The primary efficacy endpoint assessed by the proportion of patients achieving steroid free sustained remission at week 52 on RoActemra plus 26 weeks prednisone taper compared with placebo plus 26 weeks prednisone taper, was met (Table 4).
Maltese: Il-punt finali primarju tal-effikaċja evalwat skont il-proporzjon ta' pazjenti li kisbu remissjoni sostnuta ħielsa minn sterojdi f'ġimgħa 52 fuq RoActemra flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bilmod għax-xejn imqabbel ma' plaċebo flimkien ma' 26 ġimgħa ta' prednisone mnaqqas bil-mod għaxxejn, intlaħaq (Tabella 4).
English: Pack sizes of 1 and 4 vials.
Maltese: Daqsijiet tal-pakkett ta' kunjett wieħed u 4 kunjetti.
English: to 8˚C (36˚F to 46˚F).
Maltese: Żomm il-pinen mimlija għal-lest mhux użati fil-kartuna oriġinali u żommhom fil-friġġ f'temperatura ta' 2˚C sa 8˚C (36˚F sa 46˚F).
English: MTX-naïve adult patients with moderate to severe, active early RA (mean disease duration ≤ 6
Maltese: Sindrome ta' Rilaxx ta' Ċitokina (CRS) (pazjenti adulti u pedjatriċi)
English: Both study treatments induced the same pattern of changes in laboratory safety parameters (decreases in neutrophil and platelet counts, increases in ALT, AST and lipids), however, the magnitude of change and the frequency of marked abnormalities was higher with RoActemra compared with adalimumab.
Maltese: Iż-żewġ trattamenti tal-istudju induċew l-istess modi ta' bidliet fil-parametri ta' sigurtà tal-laboratorju (tnaqqis fl-għadd ta' newtrofili u plejtlits, żidiet fil-livell ta' ALT, AST u lipidi), madankollu, id-daqs tal-bidla u l-frekwenza ta' anormalitajiet sostanzjali kienu ogħla b'RoActemra meta mqabbla ma' adalimumab.
English: Hepatotoxicity
Maltese: RoActemra
English: The MAH must agree the content and format of the educational material, together with a communication plan (including means of distribution), with the national competent authority prior to distribution of the educational material.
Maltese: Qabel ma jitqassam il-materjal edukattiv, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jiftiehem mal-awtorità nazzjonali kompetenti dwar il-kontenut u d-disinn tal-materjal edukattiv, flimkien ma' pjan ta' komunikazzjoni (li jinkludi mezz ta' distribuzzjoni).
English: Store below 25°C.
Maltese: Aħżen f'temperatura taħt 25°C.
English: ATC code: G03AD02.
Maltese: Kodiċi ATC: G03AD02.
English: 59452 Lys-Lez-Lannoy France
Maltese: 59452 Lys-Lez-Lannoy Franza
English: Adolescents:
Maltese: Adolexxenti:
English: HRA Pharma Iberia S.L.
Maltese: Portugal HRA Pharma Iberia S.L.
English: Laboratorios León Farma S.A. C/ La Vallina, s/n Pol. Ind. Navatejera 24008 Navatejera, León Spain
Maltese: Laboratorios León Farma S.A. C/ La Vallina, s/n Pol. Ind. Navatejera 24008 Navatejera, León Spanja
English: Prevention of ovulation1,§
Maltese: Prevenzjoni ta' ovulazzjoni1,§
English: Pregnancy rate 0.00% 1.23% 1.29% 2.57%
Maltese: Rata ta' tqala 0.00% 1.23% 1.29% 2.57% Intervall ta' fiduċja
English: Placebo n=50
Maltese: Plaċebo n=50
English: Lactose monohydrate Povidone
Maltese: Lattożju monoidrat (lactose monohydrate) Povidone
English: Meta- analysis
Maltese: Meta-analiżi
English: Akacia Group, s.r.o.
Maltese: Česká republika Akacia Group, s.r.o.
English: Normal
Maltese: Normali
English: Biotransformation/elimination
Maltese: Bijotrasformazzjoni/eliminazzjoni
English: Odds ratio [95% CI] of pregnancy risk, ulipristal acetate vs levonorgestrel2
Maltese: Proporzjon ta' probabbiltà [95% CI] ta' riskju ta' tqala, ulipristal acetate vs levonorgestrel2
English: A&D Pharma Bulgaria Teл.
Maltese: A&D Pharma Bulgaria
English: NS: non statistically significant †: compared to placebo
Maltese: NS: mhux statistikament sinifikanti †: meta mqabbel ma' plaċebo
English: P-glycoprotein (P-gp) substrates
Maltese: Substrati tal-P-glycoprotein (P-gp)
English: HRA Pharma Italia srl, società unipersonale Tel: + 39 06 59 60 09 87
Maltese: Italia srl, società unipersonale Tel: + 39 06 59 60 09 87
English: ellaOne tablet
Maltese: ellaOne pillola
English: IUD (intrauterine device)
Maltese: IUD (apparat fil-ġuf)
English: 200 avenue de Paris 92320 CHATILLON France
Maltese: 200 avenue de Paris 92320 CHATILLON
English: Croscarmellose sodium Magnesium stearate
Maltese: Croscarmellose sodiku (croscarmellose sodium) Manjeżju stearat (Magnesium stearate)
English: Liek, s.r.o.
Maltese: Slovenská republika Liek, s.r.o.
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 21 March 2014
Maltese: Data tal-aħħar tiġdid: 21 ta' Marzu 2014
English: (See section “Pregnancy, breast-feeding and fertility”)
Maltese: (Ara sezzjoni “Tqala, treddigħ u fertilità”).
English: In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations.
Maltese: Dejta in vitro tindika li ulipristal acetate u l-metabolit attiv tiegħu ma jinibixxux b'mod sinifikanti isCYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, u 3A4, f'konċentrazzjonijiet klinikament relevanti.
English: 17, rue de Pontoise 95520 Osny France
Maltese: 17, rue de Pontoise F-95520
English: Premenstrual syndrome
Maltese: Sindromu premestrwali
English: 1: Brache et al, Contraception 2013 §: defined as presence of unruptured dominant follicle five days after late follicular-phase treatment *: compared to levonorgestrel
Maltese: 1: Brache et al, Contraception 2013 §: iddefinit bħala l-preżenza ta' follikulu dominanti mhux mifqugħ ħamest ijiem wara kura waqt fażi follikulari tardiva *: meta mqabbel ma' levonorgestrel
English: The adverse reactions reported in the phase III program of 2,637 women are provided in the table below.
Maltese: III ta' 2,637 mara huma pprovduti fit-tabella ta' hawn taħt.
English: - CYP3A4 inducers
Maltese: - Indutturi CYP3A4
English: ellaOne 30 mg tablet
Maltese: ellaOne 30 mg pillola
English: Severe hepatic impairment
Maltese: Indeboliment epatiku gravi
English: Examples of regular contraception methods:
Maltese: Eżempji ta' metodi ta' kontraċezzjoni regolari:
English: Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, and high density lipoprotein.
Maltese: Ulipristal acetate jeħel ħafna (>98%) mal-proteini tal-plażma, fosthom l-albumina, il-glikoproteina alpha-l-acid, u lipoproteina b'densità għolja.
English: HRA Pharma Benelux Tel: +32 2 709 2295
Maltese: Nederland HRA Pharma Benelux Tel: +32 2 709 2295
English: Κύπρος ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ
Maltese: ΑΡΡΙΑΝΙ
English: See section “Pregnancy, breast-feeding and fertility” for more information.
Maltese: Ara sezzjoni “Tqala, treddigħ u fertilità” għal aktar informazzjoni.
English: Titanium dioxide (E171) Polysorbate 80 (E433) Iron oxide yellow (E172) Potassium aluminium silicate (E555)
Maltese: Titanium dioxide (E171) Polysorbate 80 (E433) Ossidu tal-ħadid isfar (E172)
English: - CYP3A4 inhibitors
Maltese: - Inibituri CYP3A4
English: For the full list of excipients, see section 6.1
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Ulipristal acetate is a lipophilic compound and is distributed in breast milk, with a mean daily excretion of 13.35 µg [0-24 hours], 2.16 µg [24-48 hours], 1.06 µg [48-72 hours], 0.58 µg [72-96 hours], and 0.31 µg [96-120 hours].
Maltese: Ulipristal acetate huwa kompost lipofiliku li jiġi distribwit fil-ħalib tas-sider tal-omm, bi tnixxija medja ta' kuljum ta' 13.35 µg [0-24 siegħa], 2.16 µg [24-48 siegħa], 1.06 µg [48-72 siegħa], 0.58 µg [72-96 siegħa], u 0.31 µg [96-120 siegħa].
English: Tablet core: lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate Film coating: poly(vinyl alcohol) (E1203), macrogol (E1521), talc (E553b), titanium dioxide (E171), polysorbate 80 (E433), iron oxide yellow (E172), potassium aluminium silicate (E555)
Maltese: - Qalba tal-pillola: lattożju monoidrat, povidone, croscarmellose sodiku, manjeżju stearat - Kisja tal-pillola: poly(vinyl alcohol) (E1203), macrogol (E1521), talc (E553b), titanium dioxide
English: Ulipristal acetate is not a substrate for either OATP1B1 or OATP1B3.
Maltese: Ulipristal acetate mhuwiex substrat għal OATP1B1 jew għal OATP1B3.
English: Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.
Maltese: Is-sigurtà ta' ulipristal acetate ġiet evalwata f'4,718-il mara waqt il-programm ta' żvilupp kliniku.
English: The mono-demethylated metabolite is pharmacologically active.
Maltese: Il-metabolit monodemetilat huwa farmakoloġikament attiv.
English: Ulipristal acetate is extensively metabolised to mono-demethylated, di-demethylated and hydroxylated metabolites.
Maltese: Ulipristal acetate huwa metabolizzat b'mod estensiv f'metaboliti monodemetilati, didemetilati u idrossilati.
English: Contraceptive implant
Maltese: Metodi fit-tul Impjant kontraċettiv
English: Poly(vinyl alcohol) (E1203) Macrogol (E1521) Talc (E553b)
Maltese: Poly(vinyl alcohol) (E1203)
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu skeletali u tat-tessuti konnettivi
English: Other contraceptives and ellaOne
Maltese: Kontraċettivi oħra u ellaOne
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives.
Maltese: Ormoni sesswali u modulaturi tas-sistema ġenitali, kontraċettivi ta' emerġenza.
English: Potential for other medicinal products to affect ulipristal acetate Ulipristal acetate is metabolised by CYP3A4 in vitro.
Maltese: Ulipristal acetate jiġi metabolizzat minn CYP3A4 in vitro.
English: PVC-PE-PVDC-Aluminium blister of 1 tablet.
Maltese: Folja tal-PVC-PVDC-Aluminju ta' pillola waħda.
English: The terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ± 6.3 hours, with a mean oral clearance (CL/F) of 76.8 ± 64.0 L/h.
Maltese: Il-half-life terminali ta' ulipristal acetate fil-plażma wara doża waħda ta' 30 mg hija stmata għal 32.4 ± 6.3 sigħat, bi tneħħija orali medja (CL/F) ta' 76.8 ± 64.0 L/h.
English: Orivas SIA Tel: +371 676 124 01
Maltese: Tel: +371 676 124 01
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Mhux applikabbli.
English: How to take ellaOne
Maltese: Tiħux ellaOne
English: <{DD/MM/YYYY}>
Maltese: <{JJ/XX/SSSS}>
English: - The other ingredients are lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate.
Maltese: - Eċċipjenti l-oħra huma lattożju monoidrat, povidone, croscarmellose sodiku, manjeżju stearat.
English: 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Τηλ: + 30-(0) 210 66 83 000
Maltese: ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ Τηλ: + 30-(0)210 66 83 000
English: ellaOne 30 mg tablet Ulipristal acetate
Maltese: ellaOne 30 mg pillola Ulipristal acetate
English: Randomised controlled trial
Maltese: Prova kkontrollata randomizzata
English: The majority of women (74.6%) in the phase III studies had their next menstrual period at the expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses.
Maltese: III kellhom il-perjodu mestrwali li jmiss fil-ħin mistenni jew sa ± 7 ijiem, filwaqt li 6.8% esperjenzaw mestrwazzjoni aktar minn 7 ijiem qabel milli mistenni u 18.5% kellhom dewmien ta' iżjed minn 7 ijiem minn meta kien mistenni li tibda lmestrwazzjoni.
English: Results in vivo with the P-gp substrate fexofenadine were inconclusive.
Maltese: Riżultati in vivo mas-substrat P-gp fexofenadine ma kinux konklużivi.
English: Urticaria
Maltese: ĊEKA
English: Vaginal Ring
Maltese: Ċirku Vaġinali
English: sucursal em Portugal Tel: +351 707 501 996
Maltese: Tel: +351 707 501 996
English: Limited and inconclusive data from clinical trials suggest a possible trend for a reduced contraceptive efficacy of ulipristal acetate with high body weight or BMI (see section 4.4).
Maltese: Dejta limitata u inkonklużiva minn provi kliniċi tissuġġerixxi xejra possibbli ta' tnaqqis fl-effikaċja kontraċettiva ta' ulipristal acetate fil-preżenza ta' piż tal-ġisem jew BMI għoli (ara s-sezzjoni 4.4).
English: Genital pruritus Dyspareunia Ruptured ovarian cyst Vulvovaginal pain Hypomenorrhea*
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days.
Maltese: Fi 18,5% tan-nisa kien hemm dewmien ta' iżjed minn 7 ijiem, u f'4% d-dewmien kien ta' iżjed minn 20 ġurnata.
English: A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days.
Maltese: Minoranza (8.7%) tan-nisa rrapportaw ħruġ ta' demm bejn perjodu mestrwali u ieħor li dam medja ta' 2.4 ġranet.
English: In vivo results show that the administration of ulipristal acetate with a strong CYP3A4 inducer such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or more and decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure.
Maltese: Riżultati in vivo juru li l-għoti ta' ulipristal acetate ma' induttur qawwi ta' CYP3A4 bħal rifampicin inaqqas drastikament is-Cmax u l-AUC ta' ulipristal acetate b'90% jew aktar u inaqqas il-half-life ta' ulipristal acetate bi 2.2 drabi, li jikkorrespondi għal tnaqqis ta' madwar 10 darbiet l-esponiment ta' ulipristal acetate.
English: In vitro data indicate that this is predominantly mediated by CYP3A4, and to a small extent by CYP1A2 and CYP2A6.
Maltese: Informazzjoni in vitro tindika li dan huwa medjat prinċipalment minn CYP3A4, u sa ċertu punt minn CYP1A2 u CYP2A6.
English: Similar results were obtained for the active mono-demethylated metabolite.
Maltese: Kienu miksuba riżultati simili għall-metabolit monodemetilat (mono-demethylated) attiv.
English: Adverse reactions listed below are classified according to frequency and system organ class using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi elenkati hawn isfel huma kklassifikati skont il-frekwenza u s-sistema talklassifika tal-organi bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Adverse reactions (frequency) System organ class Common
Maltese: Reazzjonijiet avversi (frekwenza)
English: Slovenská republika
Maltese: IR-REPUBBLIKA SLOVAKKA
English: Headache Dizziness
Maltese: FEJN MA
English: Disturbance in attention Dysgueusia
Maltese: Disturbi ta' attività eċċessiva
English: Ísland
Maltese: L-ISLANDA
English: In an open-label clinical trial, which enrolled women who presented for emergency contraception and were treated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rate of 2.1% (26/1241) was observed.
Maltese: Fi prova klinika b'tikketta mikxufa, li fiha ġew reklutati nisa li resqu għal kontraċezzjoni ta' emerġenza u li ġew ikkurati b'ulipristal acetate bejn 48 u 120 siegħa wara att sesswali mhux protett, ġiet osservata rata ta' tqala ta' 2.1% (26/1241).
English: Laboratoire HRA Pharma Sími: + 33-(0)1 40 33 11 30
Maltese: Tel: + 33-(0)1 40 33 11 30
English: Nederland
Maltese: L-OLANDA
English: Nevertheless it is important that any pregnancy in a woman who has taken ellaOne be reported to www.hra-pregnancy-registry.com.
Maltese: Inti tista' wkoll tirrapporta din l-informazzjoni inti stess fuq www.hrapregnancy-registry.com.
English: Nausea*
Maltese: Ipomenorreja*
English: Although the use of ulipristal acetate for emergency contraception does not contraindicate the continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (see section 4.5).
Maltese: Minkejja li l-użu ta' ulipristal acetate għal kontraċezzjoni ta' emerġenza ma jikkontraindikax l-użu kontinwu ta' kontraċezzjoni ormonali regolari, ellaOne jista' jnaqqas l-azzjoni kontraċettiva tiegħu (ara sezzjoni 4.5).
English: This medicine will not protect you against HIV infection or any other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis).
Maltese: Din il-mediċina ma tipproteġikx kontra infezzjoni tal-HIV jew kwalunkwe mard ieħor trażmess sesswalment (eż. klamidja, ħerpes fil-ġenitali, felul fil-ġenitali, gonorrea, epatite B u sifilide).
English: All patient data collected will remain anonymous.
Maltese: Id-dejta kollha miġbura dwar il-pazjenti ser tinżamm anonima.
English: Ulipristal acetate also has high affinity for the glucocorticoid receptor and in vivo, in animals, antiglucocorticoid effects have been observed.
Maltese: Ulipristal acetate għandu wkoll affinità qawwija għar-riċettur tal-glukokortikojdi u in vivo, flannimali, ġew osservati effetti antiglukokortikojdi.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: OTHER
Maltese: SIA
English: Ulipristal acetate inhibits or postpones ovulation (see section 5.1).
Maltese: Ulipristal acetate jinibixxi jew jipposponi l-ovulazzjoni (ara sezzjoni 5.1).
English: In vitro data indicate that ulipristal acetate may be an inhibitor of BCRP (Breast Cancer Resistance Protein) transporters at the intestinal level.
Maltese: Dejta in vitro tindika li ulipristal acetate jista' jkun inibitur ta' trasportaturi ta' BCRP (Proteina ta' Reżistenza tal-Kanċer tas-Sider) fil-livell intestinali.
English: Concomitant use of ellaOne with CYP3A4 inducers is not recommended due to interaction (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicinal products containing Hypericum perforatum (St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine and long term use of ritonavir).
Maltese: L-użu konkomittanti ta' ellaOne ma' indutturi CYP3A4 mhuwiex irrakkomandat minħabba interazzjoni (eż. barbiturati (inkluż primidone u phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, prodotti mediċinali erbali li fihom Hypericum perforatum (St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine u użu fit-tul ta' ritonavir).
English: Midsona Sverige AB Tel: + 46-(0) 20 78 88 01
Maltese: Tel: + 46-(0) 20 78 88 01
English: 92320 CHATILLON France
Maltese: 200 avenue de Paris 92320 CHATILLON Franza
English: A post-marketing observational study evaluating efficacy and safety of ellaOne in adolescents aged 17 and younger showed no difference in the safety and efficacy profile compared to adult women aged 18 and older.
Maltese: Studju ta' osservazzjoni wara t-tqegħid fis-suq li jevalwa l-effikaċja u s-sigurtà ta' ellaOne f'adolexxenti ta' 17-il sena u inqas ma wera ebda differenza fil-profil tas-sigurtà u l-effikaċja meta mqabbel ma' nisa adulti ta' 18-il sena u aktar.
English: 1 film-coated tablet.
Maltese: U KONTENUT Pillola waħda.
English: Other medicines and ellaOne
Maltese: Mediċini oħra u ellaOne
English: Excipients with known effect Each tablet contains 237 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha 237 mg ta' lattożju (bħala monoidrat).
English: In vivo results show that administration of ulipristal acetate with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and 5.9-fold, respectively.
Maltese: Riżultati in vivo juru li l-għoti ta' ulipristal acetate ma' inibitur ta' CYP3A4 qawwi u moderat żied is-Cmax u l-AUC ta' ulipristal acetate b'massimu ta' 2 u 5.9 drabi, rispettivament.
English: No differences in safety or efficacy have been shown compared to adult women aged 18 and older (see section 5.1).
Maltese: Ma ntweriet ebda differenza fis-sigurtà jew l-effikaċja meta mqabbel ma' nisa adulti ta' 18-il sena jew aktar (ara sezzjoni 5.1).
English: MORE ABOUT REGULAR CONTRACEPTION
Maltese: AKTAR DWAR KONTRAĊEZZJONI REGOLARI
English: Potential for ulipristal acetate to affect other medicinal products
Maltese: Potenzjal li ulipristal acetate jaffettwa prodotti mediċinali oħra
English: Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC.
Maltese: L-għoti ta' ulipristal acetate (10 mg pillola) flimkien mal-inibitur tal-pompa tal-proton esomeprazole (20 mg kuljum għal 6 ijiem) irriżulta f'Cmax medju li huwa bejn wieħed u ieħor 65% iktar baxx, Tmax imdewwem (minn medjan ta' 0.75 sigħat għal 1.0 siegħa) u AUC li huwa 13% ogħla.
English: Pregnancy rate (%) within 72h of unprotected intercourse or contraceptive failure2
Maltese: Rata ta' tqala (%) fi ħdan 72 siegħa minn kopulazzjoni sesswali mhux protetta jew nuqqas fil-kontraċezzjoni2
English: fosphenytoine, carbamazepine, oxcarbazepine and barbiturates) - medicines used to treat tuberculosis (for example, rifampicin, rifabutin) - a treatment for HIV (ritonavir, efavirenz, nevirapine) - a medicine used to treat fungal infections (griseofulvin) - herbal remedies containing St John's wort (Hypericum perforatum).
Maltese: fosphenytoin, carbamazepine, oxcarbazepine u barbiturati) - mediċini li jintużaw biex jikkuraw it-tuberkulożi (pereżempju, rifampicin, rifabutin) - kura għall-HIV (ritonavir, efavirenz, nevirapine) - mediċina użata biex tikkura infezzjonijiet fungali (griseofulvin) - rimedji mill-ħxejjex li fihom St John's wort (Hypericum perforatum).
English: There are no antidotes and further treatment should be symptomatic.
Maltese: Ma hemm ebda antidotu u aktar kura għandha tkun sintomatika.
English: After single dose administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not likely.
Maltese: Wara amministrazzjoni ta' doża waħda, induzzjoni ta' CYP1A2 u CYP3A4 b'ulipristal acetate jew bilmetabolit attiv tiegħu mhijiex probabbli.
English: Pregnancy, breast-feeding and fertility
Maltese: Tqala, treddigħ u fertilità Tqala