FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex related to the Art. 127a Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Maltese: Anness relatat mal-artiklu 127a Kondizzjonijiet jew Restrizzjonijiet fir-rigward ta' l-użu sigur u effettiv tal-prodott mediċinali li
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) are provided with a prescriber kit containing the following: o Educational Health Care Professional's kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Maltese: • Qabel jippreskrivu (fejn jixraq, u bi ftehim mal-Awtorità Kompetenti Nazzjonali, iqassmu) il-professjonisti fil-kura tas-saħħa kollha li beħsiebhom jippreskrivu (u jiddispensaw) huma pprovduti b'Kitt għal min jippreskrivi li jkun fiha dan li ġej:
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member State shall agree the details of the Prescriber kit and a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally prior to launch to ensure that:
Maltese: L-Istat Membru għandu jiftiehem dwar id-dettalji tal-Kitt għal min jippreskrivi u sistema ta' distribuzzjoni kkontrollata mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) u għandu jimplementa dan il-programm b'mod nazzjonali qabel it-tqegħid fis-suq biex jiżgura li:
English: Difference (95 % CI) vs placebo
Maltese: Differenza (95% CI) vs plaċebo
English: * p < 0.001 vs Placebo; ° p = 0.002 vs Placebo
Maltese: * p< 0.001 vs Plaċebo; ° p = 0.002 vs Plaċebo
English: Date of latest renewal: 18/09/2014
Maltese: Data tal-aħħar tiġdid: 18/09/2014
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29/01/2010
English: Yellow iron oxide (E172) (4 mg capsules only)
Maltese: Titanium dioxide (E171) Yellow iron oxide (E172) (4 mg kapsuli biss)
English: Urorec is available in packs containing 5, 10, 20, 30, 50, 90, 100 capsules.
Maltese: Urorec jiġi f'pakketti ta' 5, 10, 20, 30, 50, 90, 100 kapsula.
English: INFORMATION IN BRAILLE Urorec 4 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Urorec 4 mg
English: INFORMATION IN BRAILLE Urorec 8 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Urorec 8 mg
English: Recordati Hellas Pharmaceuticals A.E. Τηλ: + 30 210-6773822
Maltese: Τηλ: + 30 210-6773822
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Urorec may be reduced.
Maltese: • mediċini kontra l-epilessija jew rifampicin (mediċina għall-kura tat-tuberkulożi), billi jista' jitnaqqas l-effett ta' Urorec.
English: Papaloisou Ltd. Τηλ: + 357 22 49 03 05
Maltese: Τηλ: + 357 22 49 03 05
English: PharmaSwiss d.o.o.
Maltese: PharmaSwiss UAB
English: EU/1/09/608/001 EU/1/09/608/002 EU/1/09/608/003 EU/1/09/608/004 EU/1/09/608/005 EU/1/09/608/006 EU/1/09/608/007
Maltese: EU/1/09/608/001 EU/1/09/608/002 EU/1/09/608/003 EU/1/09/608/004
English: EU/1/09/608/001 EU/1/09/608/002 EU/1/09/608/003 EU/1/09/608/004 EU/1/09/608/005 EU/1/09/608/006 EU/1/09/608/007 EU/1/09/608/008 EU/1/09/608/009 EU/1/09/608/010 EU/1/09/608/011 EU/1/09/608/012 EU/1/09/608/013 EU/1/09/608/014
Maltese: EU/1/09/608/005 EU/1/09/608/006 EU/1/09/608/007 EU/1/09/608/008 EU/1/09/608/009 EU/1/09/608/010
English: EU/1/09/608/008 EU/1/09/608/009 EU/1/09/608/010 EU/1/09/608/011 EU/1/09/608/012 EU/1/09/608/013 EU/1/09/608/014
Maltese: EU/1/09/608/011 EU/1/09/608/012 EU/1/09/608/013 EU/1/09/608/014
English: What Urorec looks like and contents of the pack Urorec 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Maltese: Urorec 8 mg huma kapsuli ibsin tal-ġelatina, bojod, opaki, daqs 0 (madwar 21.7 x 7.6 mm).
English: If you have severe kidney problems, you should not take Urorec.
Maltese: Jekk għandek problemi severi tal-kliewi, m'għandekx tieħu Urorec.
English: Other medicines and Urorec
Maltese: Mediċini oħra u Urorec
English: In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1%were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Maltese: IV li twettaq fl-Ewropa, bi skor totali tal-IPSS tal-linja bażi medju ta' 18.9 punti, 77.1% kellhom rispons għal silodosin (kif evalwat minn bidla mil-linja bażi fl-iskor totali tal-IPSS ta' mill-inqas 25%).
English: Urorec belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Maltese: Urorec jappartieni għal grupp ta' mediċini msejħa imblokkaturi tal-adrenoriċettur alpha1A.
English: Laboratoires Bouchara-Recordati Tél: + 33 1 45 19 10 00
Maltese: Tél: + 33 1 45 19 10 00
English: Tel: +385 1 63 11 833
Maltese: PharmaSwiss d.o.o. Tel: +385 1 63 11 833
English: Plasma level monitoring in a Phase III clinical study showed that levels of total silodosin after 4 weeks of treatment did not change in patients with mild impairment (n = 70), compared to patients with normal renal function (n = 155), while the levels were doubled on average in patients with moderate impairment (n = 7).
Maltese: III wera li l-livelli totali ta' silodosin wara 4 ġimgħat ta' kura ma nbidlux f'pazjenti b'indeboliment ħafif (n = 70), meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali (n = 155), filwaqt li l-livelli bħala medja rduppjaw f'pazjenti b'indeboliment moderat (n =7).
English: Focused Pharma Ltd. Tel: + 356 79426930
Maltese: Tel: + 356 79426930
English: Alpha-blockers
Maltese: Imblokkaturi alpha
English: Urorec 8 mg hard capsules Urorec 4 mg hard capsules
Maltese: Urorec 8 mg kapsuli ibsin Urorec 4 mg kapsuli ibsin silodosin
English: There is no relevant use of Urorec in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Maltese: M'hemm l-ebda użu rilevanti ta' Urorec fil-popolazzjoni pedjatrika għall indikazzjoni ta' iperplasija beninna tal-prostata (benign prostatic hyperplasia, BPH).
English: Urorec 4 mg and 8 mg hard capsules
Maltese: Urorec 4 mg u 8 mg kapsuli ibsin
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Urorec.
Maltese: • mediċini li jbaxxu l-pressjoni tad-demm (b'mod partikolari, mediċini msejħa imblokkaturi alpha1, bħal prazosin jew doxazosin) billi jista' jkun hemm ir-riskju li l-effett ta' dawn ilmediċini jiżdied waqt li tkun qed tieħu Urorec.
English: PharmaSwiss UAB Tel: + 370 5 2790762
Maltese: Tel: + 370 5 2790762
English: Urorec 8 mg hard capsules
Maltese: Urorec 8 mg kapsuli ibsin
English: Urorec 4 mg hard capsules
Maltese: Urorec 4 mg kapsuli ibsin
English: The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies.
Maltese: II-III, double-blind ikkontrollati (b'931 pazjent ħadu silodosin 8 mg darba kuljum u 733 pazjent ħadu plaċebo) u f'żewġ studji open-label ta' fażi ta' estensjoni fuq perijodu fit-tul.
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Urorec.
Maltese: • mediċini antifungali (bħal ketoconazole jew itraconazole), mediċini użati għal infezzjoni talHIV/AIDS (bħal ritonavir) jew mediċini użati wara t-trapjanti biex jevitaw ir-rifjut talorgani (bħal cyclosporin) billi dawn il-mediċini jistgħu jżidu l-konċentrazzjoni fid-demm ta' Urorec.
English: Urorec 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Maltese: Urorec 4 mg huma kapsuli ibsin tal-ġelatina, sofor, opaki, daqs 3 (madwar 15.
English: Urorec is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Maltese: Urorec jintuża f'irġiel adulti sabiex jittratta sintomi urinarji assoċjati ma' tkabbir beninn tal-prostata (iperplasija tal-prostata), bħal:
English: PHARMACEUTICAL FORM
Maltese: Focused Pharma
English: How to store Urorec
Maltese: X'inhu Urorec
English: Puh/Tel: + 353 21 4379400
Maltese: Tlf: + 353 21 4379400
English: Urorec does not treat prostate cancer.
Maltese: Urorec ma jikkurax il-kanċer tal-prostata.
English: • If you have severe liver problems, you should not take Urorec, as it was not tested in this condition.
Maltese: • Jekk għandek problemi tal-kliewi, jekk jogħġbok staqsi lit-tabib tiegħek għal parir.
English: Urorec may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Maltese: Urorec jista' jikkawża kumplikazzjonijiet waqt operazzjoni tal-katarretti (operazzjoni fl-għajnejn minħabba lenti mtappna, ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Recordati Ireland Ltd.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Recordati Ireland Ltd.
English: • Abnormal ejaculation (less or no noticeable semen is released during sex, see section “Warnings and precautions”)
Maltese: • Ħruġ anormali tas-semen (inqas jew ebda semen osservabbli li joħroġ waqt is-sess, ara s sezzjoni “Twissijiet u prekawzjonijiet”)
English: Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Maltese: Iżjed minn 800 pazjent b'sintomi moderati għal severi ta' BPH (Skor Internazzjonali tas-Sintomi tal-Prostata (International Prostate Symptom Score, IPSS), valur tal-linja bażi ≥ 13) irċevew silodosin 8 mg darba kuljum f'żewġ studji kliniċi ta' Fażi
English: Urorec 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Maltese: Urorec 4 mg kapsuli ibsin Kull kapsula iebsa fiha 4 mg silodosin.
English: If you have moderate kidney problems, your doctor will start Urorec with caution and possibly with a lower dose (see section 3 “Dose”).
Maltese: Jekk għandek problemi moderati tal-kliewi, it-tabib tiegħek jibda Urorec bil-galbu u jista' jkun li b'doża aktar baxxa (ara s-sezzjoni 3 “Doża”).
English: For special patient populations, one capsule of Urorec 4 mg daily is recommended (see below).
Maltese: Għal gruppi ta' pazjenti speċjali, hija rrakkomandata kapsula waħda ta' Urorec 4 mg kuljum (ara taħt).
English: NAME OF THE MEDICINAL PRODUCT Urorec 8 mg hard capsules silodosin
Maltese: Urorec 8 mg kapsuli ibsin silodosin
English: NAME OF THE MEDICINAL PRODUCT Urorec 4 mg hard capsules silodosin
Maltese: Urorec 4 mg kapsuli ibsin silodosin
English: • Dry mouth
Maltese: • Tnaqqis fl-aptit sesswali
English: London, 23 July 2008 EMEA/CHMP/428671/2008
Maltese: Londra, 23 ta' Lulju 2008 EMEA/CHMP/222164/2008
English: The Decentralised Procedure UK/H/0892/01/DC started on 12 April 2006.
Maltese: Il-Proċedura Deċentralizzata UK/H/0892/01/DC bdiet fit-12 ta' April 2006.
English: The Reference Member State was United Kingdom and the Concerned Member States were Austria, Germany, Finland, Ireland, Italy, Luxembourg, Netherlands and Sweden.
Maltese: L-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri konċernati kienu l-Awstrija, ilĠermanja, il-Finlandja, l-Irlanda, l-Italja, il-Lussemburgu, l-Olanda u l-Iżvezja.
English: Oracea, 40 mg, modified release capsules is an antibiotic (doxycycline), indicated for the reduction of papulopustular lesions in adult patients with facial rosacea.
Maltese: Oracea, 40 mg, kapsuli b'rilaxx modifikat huwa antibijotiku (doxycycline) indikat sabiex inaqqas illeżjonijiet papulopustulari f'pazjenti adulti b'rosaċea fil-wiċċ.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Oracea International Non-Proprietary Name (INN): doxycycline monohydrate
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA REFERENZA TAL-ARTIKOLU 29(4)1 DWAR Oracea Denominazzjoni Komuni Internazzjonali (DKI): doxycycline monoidrat
English: The Rapporteur was Dr Tomas Salmonson (SE) and Co-Rapporteur was Dr Ian Hudson (UK).
Maltese: Ir-Rapporteur kien Dr Tomas Salmonson (SE) u l-Ko-Rapporteur kien Dr Ian Hudson (UK). L-Applikant ipprovda spjegazzjonijiet bil-miktub fit-30 ta' Novembru 2007 u fit-3 ta' Marzu 2008.
English: The arbitration procedure started on 20 September 2007 with the adoption of a List of Questions.
Maltese: Il-proċedura ta' arbitraġġ bdiet fl-20 ta' Settembru 2007 bl-adozzjoni ta' Lista ta' Mistoqsijiet.
English: The applicant FGK Representative Service GmbH submitted an application for Marketing Authorisation Application of Oracea, 40 mg, modified release capsule on the basis of the marketing application to the UK on 28 February 2006.
Maltese: L-applikant, FGK Representative Service GmbH ippreżenta applikazzjoni għall-Awtorizzazzjoni għatTqegħid fis-Suq ta' Oracea, 40 mg, kapsula b'rilaxx modifikat fuq il-bażi tal-applikazzjoni għat-tqegħid fissuq fir-Renju Unit fit-28 ta' Frar 2006.
English: Significant difference had been identified with regard to the lack of sufficient safety and efficacy evidence, the emergence of bacterial resistance caused by the use of Oracea and the insufficient demonstration of a positive benefit: risk ratio.
Maltese: Ġiet identifikata differenza sostanzjali fir-rigward tan-nuqqas ta' biżżejjed provi tas-sigurtà u l-effikaċja, ilfeġġa tar-reżistenza batterjali kkawżata mill-użu ta' Oracea u l-prova mhux suffiċjenti ta' benefiċċju pożittiv: proporzjon ta' riskju.
English: During their April 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral should not prevent the granting of a Marketing Authorisation for Oracea and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Waqt il-laqgħa tiegħu ta' April 2008, is-CHMP, fid-dawl tad-dejta globali ppreżentata u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-oġġezzjonijiet li wasslu għar-Referenza tal-Artikolu 29 m'għandhomx iċaħħdu l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq għal Oracea u li s-Sommarju talKaratteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif tal-Istat Membru ta' Referenza għandhom jiġu emendati.
English: A positive opinion was therefore adopted by consensus on 24 April 2008 and the grounds for opinion, the conditions of the Marketing Authorisation and the amended SPC, labelling and package leaflet of the relevant Member State were annexed.
Maltese: Għalhekk, fl-24 ta' April 2008, ġiet adottata opinjoni pożittiva b'kunsens u r-raġunijiet għal opinjoni, il-kundizzjonijiet tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-SPC, it-Tikketta u l-Fuljett ta' Tagħrif emendati tal-Istat Membru relevanti ġew annessi.
English: These Member States were not able to reach an agreement and therefore the United Kingdom referred the reasons for disagreement to the CHMP on 27 July 2007.
Maltese: Dawn l-Istati Membri ma setgħux jilħqu ftehim u għalhekk ir-Renju Unit irrefera r-raġunijiet għan-nuqqas ta' qbil lis-CHMP fis-27 ta' Lulju 2007.
English: The full EPAR for Perjeta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Perjeta contains the active substance pertuzumab.
Maltese: Perjeta fih is-sustanza attiva pertuzumab.
English: Perjeta received a marketing authorisation valid throughout the European Union on 4 March 2013.
Maltese: Perjeta rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea fl-4 ta' Marzu 2013.
English: Perjeta was shown to be of benefit in patients whose cancer was at a high risk of coming back: after 4 years, the disease had not spread in 90% of patients with ‘node-positive' cancer treated with Perjeta compared with 87% of those receiving placebo; for those with ‘hormone-receptor negative' cancer, this figure was 91% of patients treated with Perjeta, and 89% of patients given placebo.
Maltese: Perjeta ntwera li huwa ta' benefiċċju f'pazjenti li l-kanċer tagħhom kien f'riskju għoli li jerġa' jfeġġ: wara 4 snin, il-marda ma nfirxitx f'90 % tal-pazjenti b'kanċer "nodu-pożittiv" ikkurat b'Perjeta meta mqabbel ma' 87 % ta' dawk li rċivew plaċebo; għal dawk b'kanċer "riċettur ormon negattiv", din iċċifra kienet 91 % tal-pazjenti kkurati b'Perjeta, u 89 % tal-pazjenti li ngħataw plaċebo.
English: Perjeta is given by infusion (drip) into a vein.
Maltese: Perjeta jingħata bħala infużjoni (dripp) ġo vina.
English: Other information about Perjeta
Maltese: Informazzjoni oħra dwar Perjeta
English: What are the risks associated with Perjeta?
Maltese: X'inhuma r-riskji assoċjati ma' Perjeta?
English: The most common side effects (affecting more than 3 in 10 people) with Perjeta when given with trastuzumab and chemotherapy are neutropenia (low levels of neutrophils, a type of white blood cell important for fighting infections), diarrhoea, nausea (feeling sick), vomiting, hair loss and tiredness.
Maltese: L-aktar effetti sekondarji komuni (li jaffettwaw aktar minn 3 persuni minn kull 10) b'Perjeta meta jingħata ma' trastuzumab u mal-kimoterapija huma newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellula tad-demm bajda importanti biex tiġġieled l-infezzjonijiet), dijarea, dardir (tħossok ma tiflaħx), remettar, telf ta' xagħar u għejja.
English: The recommended first dose is 840 mg given over one hour.
Maltese: Id-doża rakkomandata tal-bidu hija ta' 840 mg li tingħata fuq perjodu ta' siegħa.
English: In the first study, 46% of the patients treated with Perjeta plus trastuzumab and docetaxel responded to treatment, compared with 29% of patients who received trastuzumab and docetaxel alone.
Maltese: Fl-ewwel studju, 46 % talpazjenti kkurati b'Perjeta flimkien ma' trastuzumab u docetaxel irrispondew għall-kura, meta mqabbla ma' 29 % tal-pazjenti li ngħataw biss trastuzumab u docetaxel.
English: Response to treatment in the second study ranged from 57% to 66% where Perjeta was given with trastuzumab and chemotherapy medicines.
Maltese: Ir-rispons għall-kura fit-tieni studju varja bejn 57 % sa 66 % meta Perjeta ngħata ma' trastuzumab u mediċini tal-kimoterapija.
English: In these cases, Perjeta is used with trastuzumab and docetaxel (other cancer medicines);
Maltese: F'dawn ilkażijiet, Perjeta jintuża flimkien ma' trastuzumab u docetaxel (mediċini oħra kontra l-kanċer);
English: • treatment of early breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, after the patient has had surgery.
Maltese: • kura ta' kanċer tas-sider bikri b'riskju kbir li jerġa' jfeġġ, f'kombinazzjoni ma' trastuzumab u malkimoterapija, wara li l-pazjent tkun saritlu kirurġija.
English: The active substance in Perjeta, pertuzumab, is a monoclonal antibody, a type of protein that has been designed to attach to HER2, a protein found on HER2-positive cancer cells.
Maltese: Is-sustanza attiva f'Perjeta, il-pertuzumab, hija antikorp monoklonali, tip ta' proteina li tfasslet biex teħel ma' HER2, proteina li tinsab fuq iċ-ċelloli tal-kanċer pożittiv għall-HER2.
English: Perjeta has also been studied in two main studies involving a total of 642 patients with earlier stages of breast cancer who were to undergo surgery.
Maltese: Perjeta ġie studjat ukoll f'żewġ studji ewlenin li fihom ħadu sehem total ta' 642 pazjent b'kanċer tassider fi stadji bikrin li kienet se ssirilhom kirurġija.
English: Perjeta has been studied in one main study involving 808 adults with previously untreated HER2positive metastatic breast cancer.
Maltese: Perjeta ġie studjat fi studju ewlieni wieħed li fih ħadu sehem 808 adulti b'kanċer metastatiku tas-sider pożittiv għal HER2 li ma kinux irċevew kura preċedenti.
English: As for all medicines, data on the use of Perjeta are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Perjeta hija ssorveljata kontinwament.
English: Patients treated with Perjeta lived for 18.5 months without their disease getting worse, compared with 12.4 months for patients given placebo.
Maltese: Il-pazjenti li ġew ikkurati b'Perjeta għexu għal 18.5 xhur mingħajr ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 12.4 xhur għall-pazjenti li ngħataw il-plaċebo.
English: The effects of Perjeta were compared with placebo (a dummy treatment) when given together with other cancer medicines (trastuzumab and docetaxel).
Maltese: L-effetti ta' Perjeta tqabblu ma' plaċebo (kura finta) meta mogħti flimkien ma' mediċini oħra kontra l-kanċer (trastuzumab u docetaxel).
English: A fourth ongoing study compared Perjeta with placebo (both given with trastuzumab and chemotherapy) in 4,805 women with early breast cancer who had had surgery to remove the cancer.
Maltese: Ir-raba' studju kontinwu qabbel Perjeta ma' plaċebo (li t-tnejn li huma ngħataw ma' trastuzumab u mal-kimoterapija) f'4,805 nisa b'kanċer tas-sider bikri li saritilhom kirurġija biex jitneħħa l-kanċer.
English: • treatment of metastatic breast cancer (cancer that has spread to other parts of the body) that has not already been treated with chemotherapy medicines or medicines designed to target HER2, or for breast cancer that has come back locally after treatment and cannot be removed by surgery.
Maltese: • kura ta' kanċer tas-sider metastatiku (kanċer li nfirex lejn partijiet oħra tal-ġisem) li għadu ma ġiex ikkurat b'mediċini tal-kimoterapija jew b'mediċini mfassla b'mod biex jolqtu HER2, jew għal kanċer tas-sider li reġa' feġġ wara li tkun ingħatat il-kura u ma jistax jitneħħa b'kirurġija.
English: How is Perjeta used?
Maltese: Kif jaħdem Perjeta?
English: How does Perjeta work?
Maltese: Kif jintuża Perjeta?
English: • treatment of locally advanced, inflammatory or early-stage breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, before the patient undergoes surgery;
Maltese: • kura ta' kanċer tas-sider avvanzat, infjammatorju jew fi stadju bikri b'riskju kbir li jerġa' jfeġġ, f'kombinazzjoni ma' trastuzumab u mal-kimoterapija, qabel ma l-pazjent issirlu kirurġija;
English: It considered that this would provide an additional benefit when added to other medicines for HER2-positive cancer, notably trastuzumab.
Maltese: Huwa qies li dan se jipprovdi benefiċċju addizzjonali meta jiżdied ma' mediċini oħra kontra l-kanċer pożittiv għal HER2, b'mod partikolari trastuzumab.
English: Perjeta is a cancer medicine for treating adults with ‘HER2-positive' breast cancer (where a protein called HER2 is found on the cancer cells).
Maltese: Perjeta huwa mediċina tal-kanċer għall-kura tal-adulti b'kanċer tas-sider "pożittiv għall-HER2" (fejn proteina magħrufa bħala HER2 tinsab fuq iċ-ċelloli tal-kanċer).
English: HER2-positive breast cancer is an aggressive form of breast cancer which occurs in around one in five cases.
Maltese: Il-kanċer tas-sider pożittiv għall-HER2 huwa forma aggressiva ta' kanċer tas-sider li jseħħ f'madwar wieħed minn kull ħames każijiet.
English: Treatment with Perjeta should be interrupted or stopped permanently if the patient gets certain side effects.
Maltese: Il-kura b'Perjeta għandha tiġi interrotta jew titwaqqaf b'mod permanenti jekk il-pazjent ikollu ċerti effetti sekondarji.