FrancophonIA/ELRC3.0 huggingface dataset:
English: The clearance of total doxorubicin was 5.1 ± 4.8 l/h and the volume of distribution at steady state (Vd) was 56.6 ± 61.5 l whereas after conventional doxorubicin, clearance and Vd were 46.7 ± 9.6 l/h and 1,451 ± 258 l, respectively.
Maltese: Il-volum ta' distribuzzjoni fiss (Vd) kien ta' 56.6 ± 61.5 l.
English: If LVEF has decreased substantially from baseline e.g. by > 20 points to a final value > 50% or by > 10 points to a final value of < 50%, the benefit of continued therapy must be carefully evaluated against the risk of producing irreversible cardiac damage.
Maltese: Jekk ikun hemm tnaqqis ta' LVEF sostanzjali mill-livell ta' referenza bażi eż. b'>20 punt għal valur finali ta' > 50% jew b' > 10 punti għal valur finali ta' < 50%, il-benefiċċju li t-terapija titkompla għandha tiġi evalwata b'attenzjoni kontra r-riskju ta' ħsara irriversibbli kardijaka.
English: None 2 1000 - Less than 1500 50,000 - Less than 75,000 None 25,000 - Less than 50,000 Wait until ANC 1500 or
Maltese: Xejn 25,000 - inqas minn 50,000 Stenna sakemm l-ANC ta' 1500 jew aktar u /jew plejtlets ta' 100,000 jew aktar imbagħad iddoża millġdid bi tnaqqis ta' 25%fiddoża .
English: • Withdraw 20 ml sodium chloride solution for injection (0.9%), (not provided in the package), and inject into each vial of doxorubicin HCl, intended for preparation.
Maltese: • Iġbed 20 ml ta' (0.9%) ta' soluzzjoni ta' sodium chloride għall-injezzjoni, (mhux provdut fil pakkett), u injetta f'kull kunjett ta' doxorubicin HCl, intiż għal preparazzjoni.
English: Step 2.
Maltese: 2 Stadju.
English: Vial 1 - doxorubicin HCl
Maltese: Kunjett 1 - doxorubicin HCl
English: Specific medicinal product compatibility studies have not been performed with Myocet liposomal.
Maltese: Studji ta' interazzjoni ma' prodotti mediċinali speċifiċi ma twettqux b'Myocet liposomal.
English: The resulting reconstituted preparation of Myocet liposomal contains 50 mg of doxorubicin HCl/25 ml of liposomal dispersion (2 mg/ml).
Maltese: Il-preparazzjoni rikostitwita ta' Myocet liposomal li tirriżulta ikun fiha 50 mg ta' doxorubicin HCl/25 ml ta' tixrid liposomali (2 mg/ml).
English: If using a water bath, heat the doxorubicin HCl vial with the thermometer temperature reading 55°C-60°C for 10 minutes (not to exceed 15 minutes).
Maltese: saħħan il-kunjett ta' doxorubicin HCl bit-temperatura fuq 55°C-60°C għal 10 minuti (m'għandhiex taqbeż 15-il minuta).
English: For dose reduction of Myocet liposomal due to liver function impairment, see section 4.2.
Maltese: Għal tnaqqis fid-doża ta' Myocet liposomal minħabba indeboliment fil-funzjoni tal-fwied, ara sezzjoni 4.2.
English: Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion Liposomal doxorubicin hydrochloride
Maltese: Myocet liposomal 50 mg trab, tixrid u solvent għal konċentrat għat-tixrid għall-infużjoni Liposomal doxorubicin hydrochloride
English: Vial 1 - doxorubicin HCl lactose
Maltese: Kunjett 1 - doxorubicin HCl lactose
English: The safety and efficacy of Myocet liposomal in children aged up to 17 years has not been established.
Maltese: Is-sigurtà u effikaċja ta' Myocet liposomal fit-tfal minn età sa 17-il sena ma ġewx determinati s'issa.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100 persuna):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (1 set of 3 constituents)
Maltese: Kartuna ta' barra (1 sett minn 3 kostitwenti)
English: This is based on the size of your body (measured in “square metres” or “m2”).
Maltese: (imkejla fi “metri kwadri” jew “m2”).
English: In general however, the plasma levels of total doxorubicin are substantially higher with Myocet liposomal than with conventional doxorubicin, while the data indicate that peak plasma levels of free (not liposome-encapsulated) doxorubicin are lower with Myocet liposomal than with conventional doxorubicin.
Maltese: B'mod ġenerali madankollu, il-livelli totali ta' doxorubicin fil-plażma huma sostanzjalment ogħla b' Myocet liposomal milli b'doxorubicin konvenzjonali, filwaqt li l informazzjoni tindika li l-livelli l-aktar għolja ta' doxorubicin liberu (mhux enkapsulat f' liposomi) fil plażma huma anqas b'Myocet liposomal milli f doxorubicin konvenzjonali.
English: The recommended dose is between 60 and 75 mg of the medicine for each square meter of your body:
Maltese: Id-doża rrakkomandata hi ta' 60 u 75 mg tal-mediċina għal kull metru kwadru ta' ġismek:
English: 4.5 Interactions with other medicinal products and other forms of interactions
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: The corresponding figures for congestive heart failure, which was less accurately assessed, were 0% for Myocet liposomal + CPA versus 3% for doxorubicin + CPA, and 2% for Myocet liposomal versus 8% for doxorubicin.
Maltese: + CPA, u 2% għal Myocet liposomal kontra 8% għal doxorubicin.
English: In a third trial, Myocet liposomal (75 mg/m2) monotherapy was compared with conventional doxorubicin monotherapy (at the same dose).
Maltese: Fit-tielet prova, monoterapija b'Myocet liposomal (75 mg/m2) ġiet mqabbla ma' monoterapija konvenzjonali b'doxorubicin (fl-istess doża).
English: In animals, liposome-encapsulated doxorubicin reduced the distribution to heart and gastrointestinal mucosa compared with conventional doxorubicin, while antitumoural efficacy in experimental tumours was maintained.
Maltese: doxorubicin konvenzjonali, waqt li l-effikaċja anti-tumorali f'tumuri sperimentali baqgħet sostnuta.
English: Vial 1 - doxorubicin HCl • lactose
Maltese: Kunjett 1 - doxorubicin HCl • lactose
English: • cyclosporine - for changing your immune system.
Maltese: • cyclosporine - biex tibdel is-sistema immuni tiegħek.
English: When the 3 vials have been mixed together, your medicine contains about 108 mg sodium.
Maltese: Meta t-3 kunjetti jitħalltu ma' xulxin, il-mediċina tiegħek ikun fiha madwar 108 mg ta' sodium.
English: Pleural effusion
Maltese: Disturbi vaskulari
English: Myocet liposomal is supplied as a three-vial system as follows:
Maltese: Myocet liposomal huwa provdut f'sistema ta' tlett kunjetti:
English: As metabolism and excretion of doxorubicin occurs primarily by the hepatobiliary route, evaluation of hepatobiliary function should be performed before and during therapy with Myocet liposomal.
Maltese: Billi l-metaboliżmu u l-eskrezzjoni ta' doxorubicin iseħħu primarjament mir-rotta epatobiljari, għandu jkun hemm evalwazzjoni tal-funzjoni epatobiljari qabel u waqt it-terapija b'Myocet liposomal.
English: Caution should be exercised in the handling and preparation of Myocet liposomal.
Maltese: Għandu jkun hemm attenzjoni waqt l-imaniggjar u preparazzjoni ta' Myocet liposomal.
English: Acute overdose with Myocet liposomal will worsen toxic side effects.
Maltese: Doża eċċessiva akuta b'Myocet liposomal ser tħarrax effetti tossiċi oħrajn.
English: Other medicines and Myocet liposomal
Maltese: Mediċini oħra u Myocet liposomal
English: Myocet liposomal should be considered an irritant and precautions should be taken to avoid extravasation.
Maltese: Myocet liposomal għandu jiġi kkunsidrat bħala irritant u għandhom jittieħdu l-prekawzjonijiet meħtieġa sabiex tiġi evitata extravasation.
English: Myocet liposomal is available in cartons containing 1 set or 2 sets of 3 vials (not all pack-sizes may be marketed).
Maltese: Myocet liposomal hu disponibbli f'kaxxi tal-kartun li jkun fihom sett wieħed jew 2 settijiet ta' 3 kunjetti (jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq).
English: Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the cessation of Myocet liposomal therapy.
Maltese: Bidliet għaddiena f' ECG bħal l-illivellar tal-mewġa-T, depressjoni fis-settur S-T u arritmiji beninni m'humiex ikkunsidrati indikazzjonijiet mandatorji għat-twaqqif tat-terapija b'Myocet liposomal.
English: For dose reductions due to other toxicity, see section 4.4.
Maltese: Għal tnaqqis ta' dożi minħabba tossiċitajiet oħrajn, ara sezzjoni 4.4.
English: The following dosage modifications are recommended during therapy and should be performed in parallel for both Myocet liposomal and cyclophosphamide.
Maltese: Il-modifikazzjonijiet fid-dożi segwenti huma rrakkomandati waqt it-terapija u għandhom jitwettqu b'mod parallel kemm għal Myocet liposomal u għal cyclophosphamide.
English: Excipient(s) with known effect: The reconstituted medicinal product contains approximately 108 mg sodium for a 50 mg doxorubicin HCl dose.
Maltese: Il-prodott mediċinali rikostitwit fih madwar 108 mg ta' sodium għal doża ta' 50 mg ta' doxorubicin HCl.
English: Two alternative heating methods can be used : a Techne DB-3 Dri Block heater or a water bath:
Maltese: Ħijter Techne DB-3 Dri Block jew f'banjumarija:
English: Step 3.
Maltese: 3 Stadju.
English: The median lifetime cumulative dose of Myocet liposomal in combination with CPA to a cardiac event was > 1260 mg/m2, compared to 480 mg/m2 for doxorubicin combination with CPA.
Maltese: Id-doża medjana kumulattiva f'ħajjet iż-żmien ma' Myocet liposomal b'CPA għal xi każ kardijaku kien ta' > 1260 mg/m2, meta mqabbel ma' 480 mg/m2 għal doxorubicin flimkien ma' CPA.
English: Asthenia/Fatigue
Maltese: Stomatite/mukożite
English: In a phase III study in combination with cyclophosphamide (CPA) comparing Myocet liposomal (60 mg/m2) + CPA (600 mg/m2) versus doxorubicin (60 mg/m2) + CPA (600 mg/m2), 6% versus 21% of patients, respectively, developed a significant decrease in left ventricular ejection fraction (LVEF).
Maltese: (60 mg/m2) + CPA (600 mg/m2) ma doxorubicin (60 mg/m2) + CPA (600 mg/m2), f'6% kontra 21%
English: Liposomalencapsulated doxorubicin compared with conventional doxorubicin was not found more active in doxorubicin resistant cell lines in vitro.
Maltese: Doxorubicin enkapsulat fil-liposomi meta mqabbel ma' doxorubicin konvenzjonali ma ntweriex li hu aktar attiv f'razzez ta' ċelluli reżistenti ta' doxorubicin in vitro.
English: • The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet liposomal.
Maltese: • It-Techne DB-3 Dri Block Heater hu vverifikat b'mod sħiħ għall-użu fil-kostituzzjoni ta' Myocet liposomal.
English: These are signs of an allergic reaction and your drip (infusion) may have to be stopped:
Maltese: Dawn huma sinjali ta' reazzjoni allerġika, u d-dripp tiegħek (infużjoni) jista' jkollha titwaqqaf:
English: Congestive cardiac failure
Maltese: Insuffiċjenza kardijaka konġestiva
English: It is supplied as a three-vial system: doxorubicin HCl, liposomes and buffer.
Maltese: Hu fornut bħala sistema ta' tliet kunjetti: doxorubicin HCl, liposomi u baffer.
English: Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit Pglycoprotein (P-Gp).
Maltese: doxorubicinol, għandhom mnejn jogħlew meta doxorubicin jiġi mogħti ma'cyclosporin, verapamil, paclitaxel u sustanzi oħrajn li jimpedixxu P-glycoprotein (P-Gp).
English: When Myocet liposomal is administered in combination with cyclophosphamide (600 mg/m2) the initial recommended dose of Myocet liposomal is 60-75 mg/m2 every three weeks.
Maltese: Pożoloġija Meta Myocet liposomal jiġi mogħti flimkien ma' cyclophosphamide (600 mg/m2) d-doża inizjali rrakkomandata ta' Myocet liposomal hi ta' 60-75 mg/m2 darba kull tlett ġimgħat.
English: 50% dose reduction
Maltese: Tnaqqis b'50% tad-doża
English: Do not pass it on to others.
Maltese: Neħħi ttagħmir ta l-arja.
English: 3.1 Preparation of Myocet liposomal
Maltese: 3.1 Preparazzjoni ta' Myocet liposomal
English: • liver function tests abnormal
Maltese: • testijiet tal-funzjoni tal-fwied b'riżultat mhux normali
English: Doxorubicin is metabolised largely by the liver and excreted in the bile.
Maltese: Doxorubicin huwa prinċipalment metabolizzat fil-fwied u eliminat fil-bila.
English: A meta-analysis showed a statistically significant lower rate of grade 4 neutropenia (RR = 0.82, p=0.005) in patients treated with Myocet liposomal versus conventional doxorubicin.
Maltese: 0.82, p=0.005) f'pazjenti kkurati b'Myocet liposomal kontra doxorubicin konvenzjonali.
English: SHAKE
Maltese: Tertir
English: Myocet liposomal contains sodium
Maltese: Myocet liposomal fih is-sodium
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi u tal-għadam
English: Haemorrhagic cystitis
Maltese: Ingwanti huma meħtieġa
English: Before initiation of Myocet liposomal therapy a measurement of left ventricular ejection fraction (LVEF) is routinely recommended, either by Multiple Gated Arteriography (MUGA) or by echocardiography.
Maltese: Qabel ma' tibda terapija b'Myocet liposomal huwa rrakkomandat li kull tant żmien jittieħed il-kejl talleft ventricular ejection fraction (LVEF), jew permezz ta' Multiple Grated Arteriography (MUGA)
English: To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.
Maltese: Biex jiġi żgurat il-kontroll korrett tat-temperatura, hu rakkomandat li jintuża termometru għall immersjoni ta' 35mm.
English: It has been demonstrated that once reconstituted Myocet liposomal has a chemical and physical in-use stability at room temperature for up to 8 hours or in a refrigerator (2
Maltese: Ġie ippruvat li hekk kif Myocet liposomal ikun rikostitwit, dan ikollu stabilità kimika u fiżika waqt lużu fit-temperatura tal-kamra sa 8 sigħat jew fil-friġġ (2
English: Lymphopenia
Maltese: Ipokalemija
English: Mucositis
Maltese: Stitikezza
English: Myocet liposomal is used in adult women for the first-line treatment of breast cancer that has spread (“metastatic breast cancer”).
Maltese: Myocet liposomal jintuża f'nisa adulti għall-kura primarja ta' kanċer tas-sider li jkun infirex (“kanċer metastatiku tas-sider”).
English: 1 vial doxorubicin HCl 1 vial liposomes 1 vial buffer
Maltese: Kunjett 1 - doxorubicin HCl hu trab aħmar lajofilizzat.
English: Set up
Maltese: Preparazzjoni
English: Reconstitute doxorubicin HCl
Maltese: KUNJETT TA' DOXORUBICIN HCL
English: In addition to these three components, 0.9% (w/v) sodium chloride solution for injection will also be required for the reconstitution of the doxorubicin HCl.
Maltese: Barra minn dawn it-tlett komponenti, ikun hemm bżonn ta' soluzzjoni ta' 0.9% (w/v) sodium chloride għall-injezzjoni għar-rikostituzzjoni ta' doxorubicin HCl.
English: Neutropenic fever
Maltese: L-MEDIĊINA FIT-TEMPERATURA
English: • muscle aches, back pain, headache
Maltese: IL-KONTENUT SKONT IL-PIŻ, VOLUM, JEW PARTI
English: Add Ph-adjusted liposomes to doxorubicin
Maltese: Żid il-liposomi bil-pH irrangat għal doxorubicin
English: In the clinical program, there were nine cases of accidental extravasation of Myocet liposomal, none of which were associated with severe skin damage, ulceration or necrosis.
Maltese: Fil-programm kliniku, kien hemm disa' każijiet ta' extravasation aċċidentali b'Myocet liposomal, li lebda wieħed minnhom ma kien assoċjat ma' ħsara serja fil-ġilda, ulċerazzjoni jew nekrosi.
English: The major circulating metabolite of doxorubicin, doxorubicinol, is formed via aldo-keto-reductase.
Maltese: Livelli fil-plażma ta' doxorubicin u l-metabolit tiegħu,
English: The resulting reconstituted preparation of Myocet liposomal contains 50 mg of doxorubicin HCl/25 ml of concentrate for liposomal dispersion for infusion (2 mg/ml).
Maltese: HCl/25 ml ta' konċentrat għal tixrid liposomali għall-infuzjoni (2 mg/ml).
English: Inject into the buffer vial to adjust the pH of liposomes.
Maltese: Injetta fil-kunjett tal-baffer sabiex taġġusta l-pH ta' liposomi.
English: The total dose of Myocet liposomal should also take into account any previous, or concomitant, therapy with other cardiotoxic compounds, including anthracyclines and anthraquinones.
Maltese: Id-doża kollha ta' Myocet liposomal għandha tingħata fil-konsapevolezza ta' kull terapija li ttieħdet qabel jew flimkien ma' sustanzi kardjotossiċi oħra, inklużi anthracyclines u anthraquinones.
English: Hyperglycaemia
Maltese: Il-gradi kollha
English: 2 Painful erythema, oedema or ulcers but can eat.
Maltese: 2 Eritema b'uġigħ, edema jew ulċeri imma tista tiekol.
English: Malaise
Maltese: Mukosite
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (2 sets of 3 constituents)
Maltese: Kartuna ta' barra (2 settijiet minn 3 kostitwenti)
English: The doctor may give you a lower dose if they think you need it.
Maltese: doxorubicinol, huwa ffurmat permezz ta' aldo-keto-reductase.
English: Modification more and/or platelets 100,000 or more then redose at 25% dose reduction
Maltese: 100,000 jew aktar imbagħad iddoża mill-ġdid bi tnaqqis ta' 50% fid-doża
English: Therapy with Myocet liposomal causes myelosuppression.
Maltese: Majelosoppressjoni Terapija b'Myocet liposomal tikkaġuna majelosoppressjoni.
English: If you are not sure, talk to your doctor or nurse before having Myocet liposomal.
Maltese: Jekk m'intix ċerta, kellem lit-tabib jew lill-infermiera tiegħek qabel ma tirċievi Myocet liposomal.
English: Pericardial effusion
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: • Shake well.
Maltese: • Ħallat sew.
English: Pain
Maltese: Xejn
English: • If using a water bath, turn on the water bath and allow it to equilibrate at 58°C (55°C-60°C).
Maltese: • Jekk tuża banjumarija, ixgħel il-banjumarija u ħallih jilħaq ekwilibriju f'58°C (55°C-60°C).
English: Substances that inhibit P-glycoprotein (P-Gp) have been shown to alter the disposition of doxorubicin and doxorubicinol (see also section 4.5).
Maltese: • jekk inti allerġika għal doxorubicin jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Constipation
Maltese: PREŻENTAZZJONI
English: 2 sets each containing: 1 vial doxorubicin HCl 1 vial liposomes 1 vial buffer
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: • you have liver problems.
Maltese: • jekk għandek problemi tal-fwied.
English: • While heating proceed to step 4.
Maltese: • Waqt li qed issaħħan ipproċedi għal stadju 4.
English: Talk to your doctor or nurse before having Myocet liposomal.
Maltese: Kellem lit-tabib jew l-infermier tiegħek qabel tieħu Myocet liposomal.
English: Radiation therapy
Maltese: Terapija bir-radjazzjoni
English: 18 months
Maltese: 11 ISEM
English: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France
Maltese: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, Franza
English: Date of latest renewal: 11 January 2019
Maltese: Data tal-aħħar tiġdid: 11 ta' Jannar 2019
English: Lietuva GlaxoSmithKline Lietuva UAB
Maltese: GlaxoSmithKline Lietuva UAB
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
Maltese: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, L- Irlanda GlaxoSmithKline (Ireland) Limited logo
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Maltese: L-inalatur huwa strument magħmul minn diversi komponenti magħmul minn polypropylene, polyethylene ta' densità għolja, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene,
English: LIST OF EXCIPIENTS Excipients: lactose and magnesium stearate.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: lactose u magnesium stearate.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Maltese: (li tinnegozja bħala Glaxo Wellcome Operations) Priory Street
English: United Kingdom GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Maltese: GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: Table 1: Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint) Treatment with Incruse Ellipta 55 mcg
Maltese: Tabella 1: Il-livell minimu tal-FEV1 (ml) fil-Ġimgħa 12 u fil-Ġimgħa 24 (endpoint primarju) Kura b'Incruse Ellipta 55 mcg
English: The frequency of adverse reactions is defined 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 available data).
Maltese: 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-dejta disponibbli).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: Barcode 2D li għandha l-identifikatur uniku inkluż.
English: EU/1/14/922/002
Maltese: EU/1/14/922/001 EU/1/14/922/002
English: The other ingredients are lactose monohydrate (see section 2 under ‘Incruse Ellipta contains lactose') and magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate (ara sezzjoni 2 taħt ‘Incruse Ellipta fih lactose') u magnesium stearate.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattosju,
English: Use Incruse Ellipta regularly
Maltese: Uża Incruse Ellipta regolarment
English: Umeclidinium bromide is a substrate of cytochrome P450 2D6 (CYP2D6).
Maltese: Interazzjonijiet metaboliċi u bbażati fuq it-trasportaturi Umeclidinium bromide huwa substrat taċ-ċitokromju P450 2D6 (CYP2D6).
English: Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 (-0.4 puffs per day (95% CI: -0.7, -0.2; p<0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically significant (200109) or clinically relevant (200109 and 200110).
Maltese: puffs kuljum (95% CI: -0.7, -0.2; p<0.001) u -0.3 puffs kuljum (95% CI: -0.5, -0.1; p=0.003)) meta mqabbel ma' plaċebo flimkien ma' FF/VI, iżda t-titjib fl-SGRQ fil-ġimgħa 12 ma kienx statistikament sinifikanti (200109) jew klinikament rilevanti (200109 u 200110).
English: 1.least squares mean (95% confidence interval)
Maltese: Plaċebo mcg = mikrogramma 1. least squares mean (intervall ta' kunfidenza ta' 95%)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 April 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 28 ta' April 2014
English: Incruse Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Incruse Ellipta huwa indikat bħala kura ta' manteniment bi bronkodilatur biex itaffi s-sintomi f'pazjenti adulti b'mard kroniku ostruttiv tal-pulmun (COPD).
English: Following repeat dosing of inhaled umeclidinium bromide, steady state was achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.
Maltese: l-istat stabbli nkiseb wara 7 sa 10 ijiem b'akkumulazzjoni ta' 1.5 sa 1.8 darbiet Distribuzzjoni
English: What Incruse Ellipta contains The active substance is umeclidinium bromide.
Maltese: Is-sustanza attiva hija umeclidinium bromide.