FrancophonIA/ELRC3.0 huggingface dataset:
English: In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of ellaOne (73 women enrolled twice and 9 enrolled three times).
Maltese: III, 82 mara daħlu fl-istudju iżjed minn darba u għalhekk irċevew iżjed minn doża waħda ta' ellaOne (73 mara daħlu darbtejn u 9 daħlu tliet darbiet).
English: Detailed information on this medicine is available on the European Medicines Agency web site: 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: Appetite disorders
Maltese: Disorjentament
English: Package leaflet: Information for the user ellaOne 30 mg tablet
Maltese: Informazzjoni għall-utent ellaOne 30 mg pillola
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 għallgalattożju, id-defiċjenza ta' Lapp lattażi (Lapp lactase) jew b'assorbiment ħażin ta' glukożjugalattożju m'għandhomx jieħdu dan il-prodott mediċinali.
English: Dry throat
Maltese: Sider tari
English: The effects of CYP3A4 inhibitors are unlikely to have any clinical consequences.
Maltese: L-effetti tal-inibituri ta' CYP3A4 mhumiex probabbli li jkollhom xi konsegwenza klinika.
English: 17 Rue de Pontoise 95520 Osny France
Maltese: 17 Rue de Pontoise
English: Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Ulipristal acetate for emergency contraception is suitable for any woman of child bearing age, including adolescents.
Maltese: Ulipristal acetate għal kontraċezzjoni ta' emerġenza huwa adattat għal kull mara li tkun fl-età li tista' toħroġ tqila, inkluż adolexxenti.
English: Emergency contraception
Maltese: Kontraċezzjoni ta' emerġenza
English: Chills Malaise Pyrexia
Maltese: Menorraġija Nixxija vaġinali
English: Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via high-affinity binding to the human progesterone receptor.
Maltese: Ulipristal acetate huwa modulatur selettiv sintetiku attiv oralment tar-riċetturi ta' proġesteron li jaġixxi permezz ta' twaħħil b'affinità kbira mar-riċettur tal-proġesteron uman.
English: Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse.
Maltese: Ulipristal acetate huwa kontraċettiv ta' emerġenza li jnaqqas ir-riskju ta' tqala wara att sesswali mhux protett iżda ma jagħtix protezzjoni kontraċettiva għal atti sesswali sussegwenti.
English: Visual disturbance Abnormal sensation in eye Ocular hyperaemia
Maltese: Disturbi fil-burdata Disturb emozzjonali Sintomi ta' ansjetà
English: Contraceptive pill
Maltese: Pillola
English: Following oral administration of a single 30 mg dose, ulipristal acetate is rapidly absorbed, with a peak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) after ingestion, and with an AUC0-∞ of 556 ± 260 ng.h/ml.
Maltese: Wara l-għoti mill-ħalq ta' doża waħda ta' 30 mg, ulipristal acetate jiġi assorbit malajr, bl-ogħla konċentrazzjoni ta' 176 ± 89 ng/ml fil-plażma sseħħ madwar siegħa (0.5-2.0 h) wara li tinbela', u b'AUC0-∞ ta' 556 ± 260 ng.h/ml.
English: PVC-PVDC (with UV filter) / Aluminium blister of 1 tablet.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folja tal-PVC-PVDC (b'filtru tal-UV) / Aluminju ta' pillola waħda.
English: Post-marketing experience: the adverse reactions spontaneously reported in post-marketing experience were similar in nature and frequency to the safety profile described during the phase III program.
Maltese: Esperjenza ta' wara t-tqegħid fis-suq: ir-reazzjonijiet avversi rrapportati b'mod spontanju fl-esperjenza ta' wara t-tqegħid fis-suq kienu simili fin-natura u l-frekwenza tagħhom għall-profil tas-sigurtà deskritt matul il-programm ta' fażi
English: Each tablet contains 30 mg ulipristal acetate.
Maltese: Kull pillola fiha 30 mg ulipristal acetate.
English: Tremor
Maltese: Dismenorrea
English: If you are pregnant, it is important that you see your doctor.
Maltese: Jekk inti tqila, huwa importanti li inti tara lit-tabib tiegħek.
English: Abdominal pain* Abdominal discomfort Vomiting*
Maltese: Disturbi gastro-intestinali Nawżea* Uġigħ addominali* Skumdità addominali
English: In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations.
Maltese: Dejta in vitro tindika li ulipristal acetate jista' jkun inibitur ta' P-gp f'konċentrazzjonijiet li jkunu klinikament relevanti.
English: Administration of ulipristal acetate together with a high-fat breakfast resulted in approximately 45% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean AUC0-∞ compared with administration in the fasted state.
Maltese: L-għoti ta' ulipristal acetate flimkien ma' kolazzjon b'kontenut għoli ta' xaħam irriżulta f'Cmax medja bejn wieħed u ieħor 45% aktar baxxa, Tmax ittardjata (minn valur medjan ta' 0.75 siegħa għal 3 sigħat) u AUC0-∞ medja 25% ogħla meta mqabbel mal-għoti fuq stonku vojt.
English: Latvija
Maltese: IL-LATVJA
English: Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD): - medicines used to treat epilepsy (for example, primidone, phenobarbital, phenytoin,
Maltese: - mediċini li jintużaw biex jikkuraw l-epilessija (pereżempju, primidone, phenobarbital, phenytoin,
English: Concomitant use of ellaOne with CYP3A4 inducers (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.
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, nevirapiner u użu fit-tul ta' ritonavir).
English: The effects of the P-gp substrates are unlikely to have any clinical consequences.
Maltese: L-effetti tas-substrati P-gp mhux probabbli li jkollhom xi konsegwenzi kliniċi.
English: Ulipristal acetate is excreted in breast milk (see section 5.2).
Maltese: Ulipristal acetate hu eliminat fil-ħalib tas-sider tal-bniedem (ara sezzjoni 5.2).
English: This medicine may make regular hormonal contraceptives, like pills and patches, temporarily less effective.
Maltese: Din il-mediċina tista' taghmel kontraċettiv ormonali regolari, bħal pilloli u garżi, temporanjament inqas effikaċi.
English: - diarrhoea, heartburn, wind, dry mouth - unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal irritation or discharge, lesser or greater sex drive - hot flushes - appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine visual disturbances - influenza - acne, skin lesions, itching - fever, chills, malaise
Maltese: irritazzjoni jew tnixxija mill-vaġina , aptit aktar jew inqas għal attività sesswali - fwawar - tibdil fl-aptit, disturbi emozzjonali, ansjetà, aġitazzjoni, diffikultà biex torqod, ngħas, emigranja,
English: Of 100 women who take this medicine approximately 2 will become pregnant.
Maltese: Minn 100 mara li jieħdu din il-mediċina madwar tnejn jinqabdu tqal.
English: In addition, the second comparative trial described above also provides data on 100 women treated with ulipristal acetate from 72 to 120 hours after unprotected intercourse, in whom no pregnancies were observed.
Maltese: Barra minn hekk, it-tieni prova komparattiva deskritta fuq, tipprovdi wkoll tagħrif dwar 100 mara kkurata b'ulipristal acetate minn 72 sa 120 siegħa wara kopulazzjoni sesswali mhux protetta, li fih ma ġiet osservata ebda tqala.
English: Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a Cu-IUD.
Maltese: kontraċettiv (mhux ormonali) ta' emerġenza, jiġifieri Cu-IUD.
English: QR code linking to package leaflet to be included Package leaflet online at
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Each film-coated tablet contains 30 milligrams of ulipristal acetate.
Maltese: Kull pillola fiha 30 milligramma ta' ulipristal acetate.
English: Skin lesion Pruritus
Maltese: Piż eċċessiv
English: Golden film-coated tablet of shield shape (around 10,8 mm diameter) with “ella” engraved on both sides.
Maltese: Pillola miskija b'rita kulur id-deheb b'għamla ta' arma (dijametru ta' madwar 10,8 mm) b'“ella” imnaqqxa fuq iż-żewġ naħat.
English: Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see section 4.2).
Maltese: Adoloxxenti: il-profil tas-sigurtà osservat f'nisa li għandhom inqas minn 18-il sena fl-istudji u wara ttqegħid fis-suq huwa simili għall-profil tas-sigurtà f'adulti matul il-programm ta' fażi
English: *Symptom which could also be related to an undiagnosed pregnancy (or related complications)
Maltese: *Sintomu li jista' jkun relatat ukoll ma' tqala mhux dijanjostikata (jew kumplikazzjonijiet relatati)
English: Concomitant use is therefore not recommended (see section 4.4).
Maltese: III (ara sezzjoni 4.2).
English: ellaOne is not to be used for regular contraception
Maltese: ellaOne ma għandux jintuża bħala kontraċezzjoni regolari
English: Carcinogenicity studies (in rats and mice) showed that ulipristal acetate is not carcinogenic.
Maltese: Studji ta' karċinoġeniċità (fil-firien u l-ġrieden) urew li ulipristal acetate mhuwiex karċinoġeniku.
English: www.hra-pharma.com/PIL/GR
Maltese: http://www.hra-pharma.com/PIL/GR
English: Menorrhagia Vaginal discharge Menstrual disorder Metrorrhagia Vaginitis
Maltese: Disturbi filmestrwazzjoni Metorraġija Vaġinite
English: Results from two independent randomised controlled trials (see Table) showed the efficacy of ulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure.
Maltese: Riżultati minn żewġ provi kkontrollati randomizzati indipendenti (ara Tabella) urew li l-effikaċja ta' ulipristal acetate hija mhux inferjuri għal dik ta' levonorgestrel f'nisa li resqu għal kontraċezzjoni ta' emerġenza bejn 0 u 72 siegħa wara att sesswali mhux protett jew ta' kontraċezzjoni li ma ħadmitx.
English: You should take the tablet as soon as possible after sex, and within a maximum of 5 days (120 hours).
Maltese: Għandek tieħu l-pillola mill-aktar fis possibbli wara s-sess, u sa mhux aktar tard minn 5 ijiem wara (120 siegħa).
English: Two trials provide efficacy data on ellaOne used up to 120 hours after unprotected intercourse.
Maltese: Żewġ provi kliniċi jipprovdu tagħrif tal-effikaċja dwar ellaOne użat sa 120 siegħa wara kopulazzjoni sesswali mhux protetta.
English: Cenexi
Maltese: Manifattur Cenexi
English: It has minimal affinity to the androgen receptor and no affinity for the human estrogen or mineralocorticoid receptors.
Maltese: Huwa għandu affinità minima mar-riċettur tal-androġenu u l-ebda affinità mar-riċetturi tal-estroġenu uman jew tal-mineralokortikojdi.
English: ESTONIA
Maltese: L-ESTONJA
English: EU/1/09/522/001 EU/1/09/522/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/522/003
English: Only condoms can protect you from sexually transmitted infections.
Maltese: Il-kondoms biss jistgħu jipproteġuk minn infezzjonijiet trażmessi sesswalment.
English: Obese
Maltese: FOLJA
English: What ellaOne is and what it is used for ellaOne is an emergency contraceptive ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed.
Maltese: X'inhu ellaOne u gћalxiex jintuża ellaOne huwa kontraċettiv emerġenza ellaOne huwa kontraċettiv maħsub biex jevita t-tqala wara sess mhux protett jew jekk il-metodu kontraċettiv tiegħek ma jkunx ħadem.
English: Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
Maltese: Għaldaqstant, l-amministrazzjoni ta' ulipristal acetate mhijiex probabbli li tibdel l-eliminazzjoni ta' prodotti mediċinali li jiġu mmetabolizzati minn dawn l-enzimi.
English: Film-coated tablet
Maltese: Disturbi fil-viżta
English: Emergency contraception will not affect your fertility.
Maltese: Il-kontraċezzjoni ta' emerġenza mhux ser taffettwa l-fertilità tiegħek.
English: Women who become pregnant after taking ulipristal acetate should contact their doctor (see section 4.6).
Maltese: Nisa li joħorġu tqal wara li jieħdu ulipristal acetate għandhom jikkuntattjaw lit-tabib tagħhom (ara sezzjoni 4.6).
English: Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Maltese: Kontraċezzjoni ta' emerġenza sa 120 siegħa (5 ijiem) minn att sesswali mhux protett jew ta' kontraċettiv li ma ħadimx.
English: See leaflet for further information
Maltese: Ara l-fuljett għal aktar informazzjoni
English: Each tablet contains 30 mg ulipristal acetate
Maltese: Kull pillola fiha 30 mg ulipristal acetate
English: Talk to your pharmacist, doctor or other healthcare professional before taking this medicine - if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant (see section “Pregnancy, breast-feeding and fertility”); - if you suffer from severe asthma; - if you suffer from severe liver disease.
Maltese: peress li jaf diġà inti tqila (ara sezzjoni “Tqala, treddigħ u fertilità”); - jekk tbati minn ażżma severa; - jekk tbati minn mard tal-fwied sever.
English: Pharmacodynamic data show that even when taken immediately before ovulation is scheduled to occur (when LH has already started to rise), ulipristal acetate is able to postpone follicular rupture for at least 5 days in 78.6% of cases (p<0.005 vs. levonorgestrel and vs. placebo)
Maltese: Tagħrif farmakodinamiku juri li anki meta meħud minnufih qabel ma tkun skedata l-ovulazzjoni (meta l-LH ikun diġà beda jiżdied), ulipristal acetate huwa kapaċi jipposponi l-fqigħ follikulari għal tal-inqas 5 ijiem f'78.6% tal-każijiet (p<0.
English: Ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg) and in monkeys.
Maltese: Ulipristal acetate għandu effett letali fuq il-fetu fil-firien, fil-fniek (f'dożi ripetuti 'l fuq minn 1 mg/kg) u fix-xadini.
English: ellaOne film-coated tablet
Maltese: ellaOne fih lattożju
English: Tel: + 34-(0)902 107 428
Maltese: HRA Pharma Iberia S.L. Tel: + 34-(0)902 107 428
English: Emergency contraception can delay ovulation within a given menstrual cycle, but it will not stop you from becoming pregnant if you have unprotected sex again.
Maltese: Il-kontraċezzjoni ta' emerġenza ma tipproteġix minn infezzjonijiet trażmessi sesswalment.
English: A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception.
Maltese: Ritorn ta' malajr għall-fertilità huwa probabbli wara kura b'ulipristal acetate għal kontraċezzjoni ta' emerġenza.
English: Diarrhoea Dry mouth Dyspepsia Flatulence
Maltese: Sensazzjoni anormali flgħajnejn
English: If your menstrual period is late, there is a possibility that you may be pregnant.
Maltese: Jekk il-mestrwazzjoni tiegħek tkun tard, teżisti l-possibbiltà li nqbadt tqila.
English: Because ulipristal acetate binds to the progesterone receptor with high affinity, it may interfere with the action of progestogen-containing medicinal products: - Contraceptive action of combined hormonal contraceptives and progestogen-only contraception may be reduced - Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.4).
Maltese: - L-azzjoni kontraċettiva ta' kontraċettivi ormonali kkombinati u kontraċezzjoni bil-proġestoġen biss tista' titnaqqas - L-użu fl-istess ħin ta' ulipristal acetate u kontraċezzjoni ta' emerġenza li jkun fiha levonorgestrel mhuwiex rakkomandat (ara sezzjoni 4.4).
English: When the data from the two trials were combined via meta- analysis, the risk of pregnancy with ulipristal acetate was significantly reduced compared to levonorgestrel (p=0.046).
Maltese: Meta t-tagħrif miż-żewġ provi ġie kkombinat permezz ta' meta-analiżi, ir-riskju ta' tqala b'ulipristal acetate kien imnaqqas ferm meta mqabbel ma' levonorgestrel (p=0.046).
English: Hot flush
Maltese: Disturbi fl-aptit
English: www.hra-pharma.com/PIL/UK/GS
Maltese: http://www.hra-pharma.com/PIL/UK/GS
English: What ellaOne looks like and contents of the pack ellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
Maltese: Kif jidher ellaOne u l-kontenut tal-pakkett ellaOne huwa pillola tonda bajda għal kulur il-krema rħamata, li tiġi fit-tond, ta' dijametru ta' 9 mm imnaqqxa b'“еllа” fuq iż-żewġ naħat. ellaOne jiġi f'kartuna li fiha folja ta' pillola waħda.
English: Tablet core:
Maltese: Mhux applikabbli.
English: Medicinal products affecting gastric pH
Maltese: Prodotti mediċinali li jaffettwaw il-pH fl-istonku
English: www.hra-pharma.com/PIL/GR/GS
Maltese: http://www.hra-pharma.com/PIL/GR/GS
English: The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period.
Maltese: L-inibitur ta' CYP3A4 ritonavir jista' jkollu wkoll effett ta' induzzjoni fuq CYP3A4 meta ritonavir jintuża għal perjodu itwal.
English: The effects of ulipristal acetate on BCRP are unlikely to have any clinical consequences.
Maltese: L-effetti ta' ulipristal acetate fuq il-BCRP mhumiex probabbli li jkollhom xi konsegwenza klinika.
English: Syncope
Maltese: ĊIPRU
English: Contraceptive patch
Maltese: Mhux applikabbli
English: - Keep this leaflet.
Maltese: TA' EĊĊIPJENTI Fih lattożju.
English: Film-coating:
Maltese: Sími:
English: There is more information about contraception at the end of this leaflet.
Maltese: Hemm aktar informazzjoni dwar il-kontraċezzjoni fl-aħħar ta' dan il-fuljett.
English: No pharmacokinetic studies with ulipristal acetate have been performed in females with impaired renal or hepatic function.
Maltese: Ma sarux studji farmakokinetiċi b'ulipristal acetate f'nisa b'indeboliment fil-funzjoni renali jew epatika.
English: If you become pregnant despite taking this medicine, it is important that you see your doctor.
Maltese: Jekk tinqabad tqila minkejja li tieħu din il-mediċina, huwa importanti li tkellem lit-tabib tiegħek.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 ta' Ġunju 2016
English: What is Docetaxel Sun?
Maltese: X'inhu Docetaxel Sun?
English: Docetaxel Sun is a medicine that contains the active substance docetaxel.
Maltese: Docetaxel Sun huwa mediċina li fiha s-sustanza attiva docetaxel.
English: Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel)
Maltese: Docetaxel Sun (docetaxel)
English: The active substance in Docetaxel Sun and Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes.
Maltese: Issustanza attiva f'Docetaxel Sun u Taxotere, docetaxel, tagħmel parti mill-grupp ta' mediċini kontra lkanċer magħrufin bħala taxanes.
English: Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel) EMA/396891/2016
Maltese: EMA/396891/2016
English: Docetaxel Sun was developed as a ‘generic medicine'.
Maltese: Docetaxel Sun ġie żviluppat bħala ‘mediċina ġenerika'.
English: On 6 June 2016, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Sun, for the treatment of various types of cancer.
Maltese: Fis-6 ta' Ġunju 2016, Sun Pharmaceutical Industries Europe B.V. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Docetaxel Sun għall-kura ta' diversi tipi ta' kanċer.
English: Docetaxel Sun was to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and cancer of the head and neck.
Maltese: Docetaxel Sun kien mistenni li jintuża biex jikkura kanċer tas-sider, kanċer tal-pulmun b'ċelloli mhux żgħar, kanċer tal-prostata, adenokarċinoma gastrika (tip ta' kanċer tal-istonku) u kanċer tar-ras u talgħonq.
English: In particular, the CHMP noted that the docetaxel in Docetaxel Sun and in Taxotere is contained in tiny droplets (micelles) made with another substance, polysorbate 80, that helps the docetaxel to dissolve.
Maltese: B'mod partikolari, is-CHMP innota li docetaxel f'Docetaxel Sun u f'Taxotere huwa preżenti fi qtar żgħar (miċelli) magħmula minn sustanza oħra, polysorbate 80, li tgħin lil docetaxel jinħall.
English: Docetaxel Sun is expected to work in the same way as the reference medicine, Taxotere.
Maltese: Docetaxel Sun huwa mistenni li jaħdem bl-istess mod bħall-mediċina ta' referenza, Taxotere.
English: It was to be available as a concentrate to make a solution for infusion (drip) into a vein.
Maltese: Hija kellha tkun disponibbli bħala konċentrat biex issir soluzzjoni għall-infużjoni (dripp) ġo vina.
English: What was Docetaxel Sun expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Docetaxel Sun?
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta' mistoqsijiet u tweġibiet hawnhekk
English: No further studies were carried out because Docetaxel Sun is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Maltese: Dan ifisser li Docetaxel Sun kien intiż sabiex ikun simili għal 'mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea imsejħa Taxotere.
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Maltese: Docetaxel jimblokka l-abbiltà taċ-ċelluli li jeqirdu l-‘iskeletru' intern li
English: However, solutions containing micelles may behave differently from one another, and the CHMP considered that more information was needed to show that the Docetaxel Sun solution was similar enough in its composition and behaviour to Taxotere solution to allow a bioequivalence study to be omitted.
Maltese: Il-kumpanija ma kinitx wettqet studju sabiex turi li Docetaxel Sun huwa bijoekwivalenti għall-mediċina ta' referenza, minħabba li dan mhuwiex meħtieġ jekk il-mediċini huma soluzzjonijiet sempliċi li huma mogħtija ġo vina.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Sun could not have been approved for the treatment of cancer.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Docetaxel Sun ma setax jiġi approvat għall-kura tal-kanċer.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 January 2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 ta' Jannar 2016 EMA/55039/2016
English: It was to be available as tablets (5, 10, 15 and 30 mg) and as 10 and 15 mg orodispersible tablets (tablets that dissolve in the mouth).
Maltese: Kellu jkun disponibbli bħala pilloli (5, 10, 15 u 30 mg) u bħala pilloli li jinħallu fil-ħalq tal-10 u l-15-il mg.