FrancophonIA/ELRC3.0 huggingface dataset:
English: On 5 November, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zenhale, for the maintenance treatment of asthma.
Maltese: Fil-5 ta' Novembru, Schering-Plough Europe innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) li hija tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għattqegħid fis-suq għal Zenhale, għall-kura ta' manteniment tal-ażżma.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Maltese: Jaħdem billi jeħel ma' riċetturi beta-2 li jinstabu fiċċelloli tal-muskoli ta' bosta organi u li jġiegħlu lill-muskoli jirrilassaw.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: F'hiex kienet waslet l-evalwazzjoni tal-applikazzjoni meta din ġiet irtirata?
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Maltese: L-ittra mill-kumpnaija li biha nnotifikat lill-Aġenzija bl-irtirar tal-applikazzjoni hija disponibbli taħt it-tab ‘Id-dokumenti kollha'.
English: The company was asked to provide further data to justify the use of that comparator, specifically to show how mometasone furoate in the comparator was released in the body compared with the approved mometasone furoate.
Maltese: Il-kumpanija ntalbet tipprovdi aktar dejta biex tiġġustifika l-użu ta' dak il-komparatur, b'mod speċifiku biex turi kif mometasone furoate fil-komparatur ġie rilaxxat fil-ġisem meta mqabbel mal-mometasone furoate approvat.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zenhale could not have been approved for the maintenance treatment of asthma.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u r-rispons tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fi żmien l-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Zenhale ma setax jiġi approvat għallkura ta' manteniment tal-ażżma.
English: It was developed for use in patients whose asthma was not adequately controlled by an inhaled corticosteroid used, when needed, with an inhaled short-acting ‘beta-2 agonist' (a bronchodilator, a medicine that widens the airways in the lungs).
Maltese: Ġie żviluppat sabiex jintuża f'pazjenti li l-ażżma tagħhom ma kinitx ikkontrollata b'mod adegwat minn kortikosterojde li jinġibed għal ġol-pulmun, użat meta meħtieġ, flimkien ma' ‘agonista beta-2' li jaġixxi malajr (bronkodilatur, mediċina li twessa' l-passaġġi tal-arja fil-pulmuni).
English: The CHMP also had concerns with one of the comparator medicines, mometasone furoate, which was not in an approved formulation.
Maltese: Is-CHMP kellu wkoll tħassib dwar waħda millmediċini komparaturi, mometasone furoate, li ma kinitx fil-formolazzjoni approvata.
English: Zenhale was expected to be used in adults and adolescents aged 12 years and older as a maintenance treatment for asthma, including for reducing exacerbations (where asthma gets worse, requiring rescue treatment with other medicines).
Maltese: Zenhale kien mistenni li jintuża f'adulti u f'adoloxxenti minn 12-il sena 'l fuq bħala kura ta' manteniment għall-ażżma, inkluż għal tnaqqis ta' taħrixiet (meta l-ażżma tiggrava, u tkun teħtieġ kura ta' salvataġġ b'mediċini oħrajn).
English: The effects of Zenhale were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Zenhale ġew ittestjati għall-ewwel darba f'mudelli esperimentali qabel ma ġew studjati fuq il-bniedem.
English: It was also expected to be used in patients whose asthma was already controlled with both an inhaled corticosteroid and a long-acting beta-2 agonist.
Maltese: Kien mistenni li jintuża f'pazjenti li l-ażżma tagħhom kienet diġà kkontrollata kemm b'kortikosterojde li jinġibed għal ġolpulmun u agonisti beta-2 li jaġixxu fit-tul.
English: Table A:
Maltese: (Ara t-Tabella A:
English: <Batch> <Lot> {number}
Maltese: <Lott> <lott> {numru}
English: Clinical Pathology
Maltese: Patoloġija Klinika
English: (See Table A Pharmacokinetic Parameters)
Maltese: (Ara tTabella A Parametri Farmakokinetiċi)
English: Haemoglobin glutamer-200 (bovine) - 130 mg/ml
Maltese: Haemoglobin glutamer-200 (bovina) - 130 mg/ml
English: Name and address of the manufacturer of the biological active substance OPK Biotech LLC
Maltese: Isem u indirizz tal-manufattur tas-sustanza bioloġika attiva OPK Biotech LLC
English: * range based on mean ± SD ** range based on estimated mean value with bounds of a 95 % prediction interval *** range based on 5 terminal half-lives
Maltese: ** medda bbażata fuq stima ta' valur medju b'limiti ta' interval ta' tbassir ta' 95 % *** medda bbażata fuq 5 half-lives terminali
English: Excipients:
Maltese: Ematoloġija:
English: 125 ml - 5years
Maltese: 60 ml - 3 snin 125 ml - 5 snin
English: In certain clinical situations, a dosage of 15-30 ml/kg may be appropriate.
Maltese: F'ċerti sitwazzjonijiet kliniċi, dożaġġ ta' 15-30 ml/kg jista' jkun adattat.
English: Sodium lactate N-acetyl-l cysteine
Maltese: CaC12 2H2O NaOH sodium lactate N-acetyl-l cysteine
English: Date of first authorisation: 29/11/1999 Date of last renewal: 01/10/2009
Maltese: Data tal-ewwel awtorizazzjoni: 29/11/1999 Data tal-aħħar tiġdid: 01/10/2009
English: Cleared from plasma (days)***
Maltese: Imneħħi mill plasma (jiem)***
English: Dipstick measurements (i.e., pH, glucose, ketones, protein) are inaccurate while gross discolouration of the urine is present.
Maltese: Kejl bl-istikka (i.e., pH, glukosju, ketoni, proteina) mhuwiex preċiż, filwaqt li hemm tibdil fil-kulur totali ta' l-awrina.
English: Modified Lactated Ringer's Solution containing the standard components: Water for injection, NaCl
Maltese: Modified Lactated Ringer's Solution li fiha l-komponenti standard:
English: Do not store above 30 °C.
Maltese: Taħżinx f'temperaturi ogħla minn 30° C.
English: 125 ml infusion bag.
Maltese: Borża ta' infużjoni ta' 125 ml.
English: Manufacturer for the batch release: Dales Pharmaceutical Ltd. Snaygill Industrial Estate Keighley Road
Maltese: Snaygill Industrial Estate Keighley Road
English: Metabolism and excretion: Haemoglobin dissociates in plasma and is progressively incorporated in the protein pool of the organism.
Maltese: L-emoglobina tinfired fil-plasma u hija progressivament inkorporata fit-taħlita ta' proteini ta' l-organiżmu.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Marketing authorisation holder: OPK Biotech Netherlands BV Teleportboulevard 140
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ : OPK Biotech Netherlands BV Teleportboulevard 140
English: Excessive administration rate (>10 ml/kg/h) may result in circulatory overload.
Maltese: Rata eċċessiva ta' amministrazzjoni (>10 ml/kg/siegħa) tista' tirriżulta f'tagħbija ċirkolatorja żejda.
English: It is eliminated from the plasma in 5-7 days.
Maltese: Huwa eliminat mill-plasma f'57 t'ijiem.
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Solution for infusion.
Maltese: Mhux Applikabbli.
English: Oxyglobin is intended for single administration.
Maltese: Oxyglobin huwa maħsub sabiex jiġi amministrat darba biss.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)jekk ikun hemm bżonn
English: Optical methods are not reliable for coagulation assays in the presence of Oxyglobin.
Maltese: Metodi optiċi m'humiex affidabbli għal assaġġi ta' koagulazzjoni fil-preżenza ta' Oxyglobin.
English: Haeme degrades according to common pathways leading to bilirubin and bile pigments.
Maltese: L-haeme tiddegrada skond rotot komuni li jwasslu għal bilirubin u pigmenti tal-bili.
English: 1043EJ, Amsterdam The Netherlands
Maltese: 1043EJ
English: A box with one (1) polyolefin infusion bag (containing either 60 ml or 125 ml), within an overwrap.
Maltese: Kaxxa b'borża waħda (1) ta' infużjoni ta' polyolefin (li fiha jew 60 ml jew 125 ml), fi tgeżwir ta' barra.
English: Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) can be accurately determined using methods that are mechanical, magnetic, and light scattering.
Maltese: Prothrombin time (PT) u activated partial thromboplastin time (aPTT) jistgħu jiġu determinati b'mod preċiż billi jiġu wżati metodi li huma mekkaniċi, manjetiċi u li jifirxu d-dawl.
English: Table A: Pharmacokinetic Parameters at Multiple Dose Levels after a Single Infusion of Oxyglobin Dose (ml/kg)
Maltese: Tabella A: Parametri Farmakokinetiċi fil-Livelli ta' Dożi Multipli Wara Infużjoni Waħdanija ta'
English: 60 ml infusion bag.
Maltese: Borża ta' infużjoni ta' 60 ml.
English: Overdosage or an excessive rate of administration (i.e., >10 ml/kg/h) could result in immediate cardiopulmonary effects, in which case infusion of Oxyglobin should be discontinued immediately until signs abate.
Maltese: Doża eċċessiva jew rata eċċessiva ta' għoti (i.e., >10 ml/kg/siegħa) jista' jkollha effetti kardjopulmonarji immedjati, f'liema każ l-infużjoni ta' Oxyglobin għandha titwaqqaf immedjatament sakemm ibattu s-sinjali.
English: 60 ml infusion bag 125 ml infusion bag
Maltese: Borża ta' infużjoni ta' 60 ml Borża ta' infużjoni ta' 125 ml
English: Oxyglobin Dose (ml/kg)
Maltese: (ml/kg)
English: CaC12 2H2O
Maltese: QB05AA10
English: Dogs
Maltese: Doża
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI
English: INDICATION(S)
Maltese: U INGREDJENT(I)
English: Effects commonly seen were vomiting, loss of appetite, fever, and circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds, and pulmonary oedema; circulatory overload was controlled by slowing the rate of administration.
Maltese: Effetti komuni li dehru kienu remmettar, nuqqas ta' aptit, deni, tagħbija ċirkolatorja żejda b'sinjali kliniċi assoċjati bħal rata ta' nifs mgħaġġel, qtugħ ta' nifs, ħsejjes ħorox mill-pulmun, u edema pulmonarja; it-tagħbija ċirkolatorja żejda ġiet ikkontrollata billi ġiet imnaqqsa r rata ta' infużjoni.
English: A small amount of unstabilised tetrameric haemoglobin (<5 %) may be excreted through the kidneys, resulting in transient haemoglobinuria for < 4 hours.
Maltese: Jista' jiġi eliminat mill-ġisem, ammont żgħir ta' emoglobina tetramerika mhux stabbilizzata (< 5%), li jirriżulta f'emoglobinurja li tgħaddi f'inqas minn 4 sigħat.
English: Immediate post infusion plasma concentration* (g/dl)
Maltese: plasma immedjatament wara l- infużjoni*
English: PACKAGE LEAFLET: Oxyglobin 130 mg/ml solution for infusion for dogs
Maltese: FIL-PAKKETT: Oxyglobin 130 mg/ml soluzzjoni għal infużjoni għal klieb
English: CONTRAINDICATIONS
Maltese: FILPAKKETT
English: Occasionally noted effects were diarrhoea, discolouration of the skin, cardiac arrhythmias and very rarely nystagmus.
Maltese: B'mod okkażjonali ġew innutati effetti bħalma huma d-dijarea, tifi fil-kulur talġilda, arrittmiji kardijaċi u rari ħafna nistagmus.
English: Oxyglobin 130 mg/ml solution for infusion for dogs
Maltese: VETERINARJU Oxyglobin 130 mg/ml soluzzjoni għal infużjoni għall-klieb
English: The recommended dosage of Oxyglobin is 30 ml/kg of body weight administered intravenously at a rate up to 10 ml/kg/hr.
Maltese: Id-dożaġġ rakkommandat ta' Oxyglobin huwa ta' 30 ml/kg tal-piż tal-annimal meta mogħti ġol-vina b'rata sa 10 ml/kg fis-siegħa.
English: Duration hours): Oxyglobin levels over 1 g/dL**
Maltese: Livelli ta' oxyglobin ‘l fuq minn 1 g/dL
English: Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter.
Maltese: Oxyglobin għandu jiġi mogħti billi tintuża teknika aseptika permezz ta' sett ta' infużjoni standard fil-vina, u katiter.
English: Undesirable effects include mild to moderate yellow/orange discoloration of the skin, mucous membranes, sclera, dark faeces and discoloured or turbid urine due to metabolism and/or excretion of haemoglobin.
Maltese: Effetti mhux mixtieqa jinkludu tifi ħafif għal moderat safrani/oranġju fil-kulur tal-ġilda, filmembrani mukużi, sklera, ħmieġ skur u awrina mdardra minħabba l-metaboliżmu u/jew il-ħruġ ta' l emoglobina.
English: Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours independent of the underlying condition.
Maltese: Oxyglobin jipprovdi għajnuna ta' ġarr ta' ossiġenu fil-klieb u għaldaqstant itejjeb is-sinjali kliniċi ta' anemija għal mill-anqas 24 siegħa indipendentement minn mard ieħor.
English: To be supplied only on veterinary prescription.
Maltese: Biss - għandu jingħata biss bi preskrizzjoni medika.
English: Chemistry: The presence of Oxyglobin in serum may interfere with colorometric readings and result in artifactual increases or decreases in the results of serum chemistry tests depending on the dosage administered, the time since infusion, the type of analyzer and the reagents used.
Maltese: Il-preżenza ta' Oxyglobin fis-serum tista' tinterferixxi mal-qari kolorometriku u tista' tirriżulta f'żjidiet jew tnaqqis artifattwali fir-riżultati tat-testijiet kimiċi tas-serum jiddependi fuq id- dożaġġ mogħti, il-ħin sa mill-infużjoni, it-tip ta' analizzatur u l-kimiċi wżati fl-analiżi.
English: Pharmacotherapeutic group: Blood substitutes, ATCvet code: QB05AA10.
Maltese: Sostituti tad-demm, Kodici ATĊ veterinarja:
English: NaOH
Maltese: Xejn
English: Do not microwave.
Maltese: Tpoġġihx filmicrowave.
English: Name and address of the manufacturer responsible for batch release Dales Pharmaceutical Ltd. Snaygill Industrial Estate Keighley Road Skipton
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija
English: Side effects which were observed included mild to moderate discolouration of the mucous membranes, sclera, and urine due to metabolism and/or excretion of haemoglobin.
Maltese: Effetti oħra li ġew osservati jinkludu t-tifi tal-kulur tal-membrani mukużi, sklera, u l-awrina minħabba l-metaboliżmu u/jew il-ħruġ ta' l-emoglobina.
English: 4.5 Special precautions for use Special precautions for use in animals
Maltese: 4.5 Prekawzjonijiet Speċjali għall-Użu
English: Solution for infusion
Maltese: Mhux applikabbli
English: Plasma volume expanders, such as Oxyglobin, are contraindicated in dogs predisposed to circulatory overload with conditions such as oliguria or anuria or advanced cardiac disease (i.e., congestive heart failure) or otherwise severely impaired cardiac function.
Maltese: Sustanzi li jkabbru l-volum tal-plasma, bħalma huwa Oxyglobin huma kontra-indikati fi klieb predisposti għal tħaddim ċirkolatorju żejjed b'kundizzjonijiet bħalma huma oligurja jew anurja jew mard avvanzat tal-qalb (i.e., falliment tal-qalb minħabba konġestjoni) jew tħaddim tal-qalb severament indebolit.
English: PHARMACOLOGICAL PROPERTIES
Maltese: Parametri Farmakokinetiċi)
English: Haematology: No interference.
Maltese: L-ebda interferenza.
English: D. STATEMENT OF THE MRLs
Maltese: (g/dl)
English: Keep out of the reach and sight of children.
Maltese: Eżaminazzjoni tas-sediment hija preċiża.
English: Use within 24 hours of removing overwrap.
Maltese: Uża fi żmien 24 siegħa minn meta tneħħi t- tgeżwir ta' barra.
English: 6.3 Shelf life
Maltese: ANNESS III
English: <EXP {month/year}>
Maltese: <Jiskadi {xahar / sena}>
English: Occasionally noted adverse events were diarrhoea, cardiac arrhythmias and very rarely nystagmus.
Maltese: Kultant ġew innotati każijiet ta' dijarea, arrittmiji kardijaċi, u rari ħafna nistagmus.
English: Do not overheat.
Maltese: Neħħi t-tgeżwir qabel l-użu.
English: Oxyglobin is intended for single administration only.
Maltese: Oxyglobin huwa ntenzjonat li jingħata darba biss.
English: Ibrance is available as capsules (75 mg, 100 mg and 125 mg).
Maltese: Ibrance jiġi f'kapsuli (75 mg, 100 mg u 125 mg).
English: The full EPAR for Ibrance 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: Ibrance contains the active substance palbociclib.
Maltese: Ibrance fih is-sustanza attiva palbociclib.
English: Other information about Ibrance
Maltese: Informazzjoni oħra dwar Ibrance
English: • together with an aromatase inhibitor (a hormonal medicine for cancer);
Maltese: • flimkien ma' inibitur ta' aromatase (mediċina ormonali għall-kanċer);
English: This is a summary of the European public assessment report (EPAR) for Ibrance.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ibrance.
English: Why is Ibrance approved?
Maltese: Għaliex ġie approvat Ibrance?
English: The most common side effects with Ibrance (which may affect more than 1 in 5 people) are neutropenia (low blood levels of neutrophils, a type of white blood cell that fights infection), infections, leucopenia (low white blood cell counts), tiredness, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), anaemia (low red blood cell counts), alopecia (hair loss) and diarrhoea.
Maltese: L-effetti sekondarji l-aktar komuni b'Ibrance (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma newtropenija (livelli baxxi tad-demm ta' newtrofili, tip ta' ċellola bajda tad-demm li tiġġieled kontra infezzjoni), infezzjonijiet, lewkopenija (għadd baxx taċ-ċelloli bojod tad-demm), għeja, nawsja (tħossok ma tiflaħx), stomatite (infjammazzjoni tal-kisja tal-ħalq), anemija (għadd baxx ta' ċelloli taddemm ħomor), alopeċja (waqa' tax-xagħar) u dijarea.
English: The recommended dose is 125 mg once a day for 21 consecutive days, followed by a 7-day break to complete a 28-day treatment cycle.
Maltese: Id-doża rakkomandata hija 125 mg darba kuljum għal 21 jum konsekuttiv, segwiti minn pawża ta' 7 ijiem biex iċ-ċiklu ta' kura ta' 28 jum jiġi komplut.
English: The active substance in Ibrance, palbociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide.
Maltese: Is-sustanza attiva f'Ibrance, palbociclib, timblokka l-attività ta' enzimi magħrufin bħala kinase 4 u 6 li jiddependu fuq is-cyclin (CDK, cyclin-dependent kinases), li għandhom rwol ewlieni biex jirregolaw ilmod kif iċ-ċelluli jikbru u jinqasmu.
English: The most common severe side effects with Ibrance (which may affect up to 1 in 50 people) are neutropenia, leucopenia, anaemia, tiredness and infections.
Maltese: L-effetti sekondarji l-aktar severi b'Ibrance (li jistgħu jaffettwaw sa persuna 1 minn 50) huma newtropenja, lewkopenja, anemija, għeja u infezzjonijiet.
English: Women taking Ibrance and fulvestrant lived on average 11.2 months without their disease getting worse compared with 4.6 months for women taking placebo and fulvestrant.
Maltese: Bħala medja, in-nisa li ħadu Ibrance u fulvestrant għexu għal 11.2 xhur mingħajr ma aggravat il-marda tagħhom meta mqabbla ma' 4.6 xhur għal nisa li ħadu plaċebo u fulvestrant.
English: What are the risks associated with Ibrance?
Maltese: X'inhuma r-riskji assoċjati ma' Ibrance?
English: Regarding safety, the main risk is neutropenia, which is a well-known risk of many cancer medicines and is considered manageable.
Maltese: Rigward is-sigurtà, ir-riskju ewlieni huwa nnewtropenja, li hija riskju magħruf ta' ħafna mediċini kontra l-kanċer u hija meqjusa maniġġevoli.
English: In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably.
Maltese: F'xi kanċers, inkluż kanċer tas-sider pożittiv għall-HR, l-attività ta' CDK 4 u 6 tiżdied, u din tgħin biex iċ-ċelluli tal-kanċer jimmultiplikaw bla kontroll.
English: Women taking Ibrance and letrozole lived on average 24.8 months without their disease getting worse compared with 14.5 months for women taking placebo and letrozole.
Maltese: Bħala medja, in-nisa li ħadu Ibrance u letrozole għexu għal 24.8 xhur mingħajr ma aggravat il-marda tagħhom meta mqabbla ma' 14.5 xhur għal nisa li ħadu plaċebo u fulvestrant.
English: Ibrance must not be used by patients who are taking St John's wort (a herbal preparation used to treat depression).
Maltese: Ibrance m'għandux jintuża minn pazjenti li jkunu qed jieħdu St John's wort (preparazzjoni erbali użata biex tikkura d-dipressjoni).
English: The first study involved 521 women with metastatic breast cancer that had got worse after treatment with a hormonal medicine.
Maltese: L-ewwel studju kien jinvolvi 521 mara b'kanċer tas-sider metastatiku li marru agħar wara l-kura b'mediċina ormonali.
English: By blocking CDK4 and CDK6, Ibrance slows the growth of HRpositive breast cancer cells.
Maltese: Billi jimblokka CDK4 and CDK6, Ibrance inaqqas it-tkabbir taċ-ċelluli tal-kanċer tas-sider pożittiv għall-HR
English: • together with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.
Maltese: • flimkien ma' fulvestrant (mediċina ormonali oħra għall-kanċer) f'pazjenti li kienu kkurati minn qabel b'mediċina ormonali.
English: Ibrance has been shown to prolong the time patients live without their disease getting worse by an average of 6 to 10 months, which is considered of clear clinical value.
Maltese: Ibrance ntwera li jtawwal il-ħin li l-pazjenti jgħixu mingħajr ma taggrava l-marda tagħhom b'medja ta' 6 sa 10 xhur, li huwa meqjus valur kliniku ċar.
English: In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.
Maltese: F'nisa li għadhom mhux fl-età tal-menopawża, għandha tingħata wkoll mediċina msejħa agonista ta' ormon li jistimula l-produzzjoni tal-ormon ta' lutejinazzjoni
English: For the full list of all side effects reported with Ibrance, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Ibrance, ara l-fuljett ta' tagħrif.
English: Ibrance is a cancer medicine used to treat locally advanced or metastatic breast cancer (cancer that has begun to spread to other parts of the body).
Maltese: Ibrance huwa mediċina kontra l-kanċer użata għall-kura ta' kanċer tas-sider lokalment avvanzat jew metastatiku (kanċer li jkun beda jinfirex għal partijiet oħra tal-ġisem).
English: What measures are being taken to ensure the safe and effective use of Ibrance?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Ibrance?
English: They received either Ibrance and letrozole (an aromatase inhibitor) or placebo and letrozole.
Maltese: Dawn irċevew jew Ibrance u fulvestrant jew plaċebo (mediċina finta) u fulvestrant.
English: Ibrance has been studied in two main studies of women with HR-positive, HER2-negative breast cancer.
Maltese: Ibrance jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda u tkun sorveljata minn tabib b'esperjenza fl-użu ta' mediċini kontra l-kanċer.
English: Treatment should continue for as long as the patient is benefitting from it and side effects are tolerable.
Maltese: Il-kura għandha tkompli sakemm il-pazjent ikun qed jibbenefika minnha u l-effetti sekondarji jkunu tollerabbli.
English: Ref. EMEA/294089/2008
Maltese: EMEA/391204/2008
English: International non-proprietary name (INN): lenalidomide
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): lenalidomide
English: Lenalidomide Celgene Europe was designated as an orphan medicinal product on 8 March 2004.
Maltese: Lenalidomide Celgene Europe ġie klassifikat bħala prodott mediċinali orfni fit-8 ta' Marzu 2004.
English: The active substance in Lenalidomide Celgene Europe, lenalidomide, is an immunomodulating agent.
Maltese: Is-sustanza attiva f'Lenalidomide Celgene Europe, lenalidomide, hija aġent immunomodulanti.