FrancophonIA/ELRC3.0 huggingface dataset:
English: No cases of progressive multifocal leukoencephalopathy (PML) have been reported for siponimod in the development programme; however, they have been reported for another S1P receptor modulator.
Maltese: Ma kinux irrappurtati każijiet ta' lewkoenċefalopatija multifokali progressiva (PML) b'siponimod tul ilprogramm ta' żvilupp; madanakollu, kienu rrappurtati fil-każ ta' modulatur ieħor tar-riċettur S1P.
English: In embryofoetal development studies conducted in rats and rabbits, siponimod induced embryotoxic effects in the absence of maternal toxicity.
Maltese: Waqt studji dwar l-iżvilupp embrijofetali mwettqa fost il-firien u l-fniek, siponimod qanqal ettetti embrijotossiċi fin-nuqqas ta' tossiċità maternali.
English: problems seeing colours or details (symptoms of macular oedema, which is a swelling in the macular area of the retina at the back of the eye)
Maltese: problemi biex tara l-kuluri jew id-dettalji (sintomi ta' edima makulari, li hi nefħa fiż-żona makulari tar-retina fuq wara tal-għajn)
English: Mayzent 0.25 mg film-coated tablets
Maltese: Mayzent 0.25 mg pilloli miksija b'rita
English: When stopping siponimod therapy for planning a pregnancy, the possible return of disease activity should be considered (see section 4.4).
Maltese: Meta titwaqqaf it-terapija b'siponimod sabiex dak li jkun ikun jista' jħejji għat-tqala, wieħed irid iqis ilpossibbiltà li terġa' tfiġġ l-attività tal-marda (ara sezzjoni 4.4).
English: • Have a negative pregnancy test before starting siponimod, which should be repeated at suitable intervals.
Maltese: • Ikollhom test tat-tqala negattiv qabel ma jitnieda siponimod, li għandu jerġa' jsir f'intervalli xierqa.
English: By acting as a functional antagonist on S1P1 receptors on lymphocytes, siponimod prevents egress from lymph nodes.
Maltese: Billi jaġixxi bħala antagonist funzjonali tar-riċetturi ta' S1P1 fuq il-limfoċiti, siponimod ma jħallix il-kapaċità tallimfoċiti li joħorġu mill-għeqiedi limfatiċi.
English: • Monitoring requirements at treatment initiation: Prior to initiating treatment: o Perform vitals and baseline ECG prior to the first dose of siponimod in patients with sinus bradycardia (heart rate [HR] <55 bpm), history of first- or second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure (patients with NYHA class I and II).
Maltese: o Wettaq ECG vitali u fil-linja bażi qabel l-ewwel doża ta' siponimod f'pazjenti bi bradikardija tas-sinus (ir-rata tat-taħbit tal-qalb [HR] <55 bpm), bi storja ta' imblokk AV tal-ewwel jew tat-tieni grad [Mobitz tat-tip II], jew bi storja ta' infart mijokardijaku jew insuffiċjenza kardijaka (pazjenti b'NYHA klassi I u II).
English: Siponimod is eliminated from the systemic circulation mainly due to metabolism and subsequent biliary/faecal excretion.
Maltese: Siponimod jitneħħa miċ-ċirkulazzjoni sistemika primarjament permezz tal-metaboliżmu u sussegwentament mal-bili/mal-ippurgar.
English: Before initiation of treatment, women of childbearing potential must be informed of this risk to the foetus, must have a negative pregnancy test and must use effective contraception during treatment and for at least 10 days after treatment discontinuation (see sections 4.3 and 4.6).
Maltese: Qabel it-tnedija tat-trattament, nisa li jistgħu joħorġu tqal għandhom ikunu mgħarrfa dwar dan ir-riskju għall-fetu, irid ikollhom test negattiv tat-tqala u jridu jużaw kontraċezzjoni effettiva matul it-trattament u għal mill-inqas għaxart ijiem wara li jitwaqqaf it-trattament (ara sezzjonijiet 4.3 u 4.6).
English: Clinical studies included patients up to the age of 61 years.
Maltese: Studji kliniċi kienu jinkludu pazjenti saletà ta' 61 sena.
English: • Be informed before treatment initiation and regularly thereafter by their physician about siponimod serious risks to the foetus and about the contraindication in pregnant women and in women of childbearing potential not using effective contraception, facilitated by the Pregnancy Reminder Card.
Maltese: • Ikunu mgħarrfa qabel it-tnedija tat-trattament u wara b'mod regolari mit-tabib tagħhom dwar irriskji serji ta' siponimod għall-fetu u dwar il-kontraindikazzjoni f'nisa tqal u f'nisa li jistgħu joħorġu tqal li mhumiex qed jużaw kontraċezzjoni effettiva, bl-għajnuna tal-Kartuna ta' Tfakkir dwar Tqala.
English: Results from the study showed a variable but consistent risk reduction in the time to 3- and 6-month CDP with siponimod compared to placebo in subgroups defined based on gender, age, pre-study relapse activity, baseline MRI disease activity, disease duration and disability levels at baseline.
Maltese: Ir-riżultati mill-istudju wrew tnaqqis varjabbli imma konsistenti fir-riskju minn dak iż-żmien sa tliet xhur u sitt xhur ta' CDP b'siponimod imqabbel mal-plaċebo fost is-sottogruppi ddefiniti skont is-sess, l-età, lattività ta' rikaduta qabel l-istudju, l-attività tal-marda skont l-MRI fil-linja bażi, id-dewmien tal-marda u llivelli ta' diżabbiltà fil-linja bażi.
English: Proportion of patients with 3-month confirmed disability progression (primary endpoint) Risk reduction
Maltese: Proporzjon ta' pazjenti bi progressjoni kkonfermata tad-diżabbiltà għal tliet xhur (endpoint primarju)
English: Mayzent 2 mg film-coated tablets are pale yellow, round film-coated tablets with the company logo on one side and “II” on the other side.
Maltese: Mayzent 2 mg pilloli miksija b'rita huma ta' lewn isfar mitfi, pilloli tondi miksija b'rita bil-lowgo talkumpanija fuq naħa minnhom u “II” fuq in-naħa l-oħra.
English: Due to its functional antagonism at S1P1 receptors, initial titration of siponimod successively desensitises GIRK channels until the maintenance dose is reached.
Maltese: Minħabba l-antagoniżmu funzjonali tiegħu fuq livell ta' riċetturi ta' S1P1, it-titrazzjoni inizjali ta' siponimod tiddisentisizza eventwalment il-kanali ta' GIRK sakemm tintlaħaq id-doża ta' manutenzjoni.
English: • fluconazole and certain other medicines can increase the levels of Mayzent in the blood and are not recommended to be taken in combination with Mayzent.
Maltese: • fluconazole u ċerti mediċini oħrajn jistgħu jgħollu l-livelli ta' Mayzent fid-demm u mhuwiex irrakkomandat li jittieħdu flimkien ma' Mayzent.
English: • medicines that affect the immune system, such as chemotherapy, immunosuppressants or other medicines to treat MS.
Maltese: • mediċini li jaffettwaw is-sistema immuni, bħal kemjoterapija, immunosuppressanti jew mediċini oħrajn li jittrattaw l-MS.
English: • A case of cryptococcal meningitis (CM) has been reported for siponimod.
Maltese: • Kien irrappurtat każ ta' meninġite kriptokokkali (CM) meta mogħti siponimod.
English: • Visual disturbances such as a shadow or a blind spot in the centre of vision, blurred vision,
Maltese: • Disturbi fil-vista bħalma huma dellijiet jew blind spot fiċ-ċentru tal-vista tiegħek, vista mċajpra,
English: You must use effective contraception during treatment and up to 10 days after stopping treatment (see “Pregnancy, breast-feeding and fertility”).
Maltese: Inti għandek tuża kontraċezzjoni effettiva waqt it-trattament u sa għaxart ijiem wara li jitwaqqaf it-trattament (ara “Tqala, treddigħ u fertilità”).
English: This concomitant drug regimen can consist of a moderate CYP2C9/CYP3A4 dual inhibitor (e.g. fluconazole) or a moderate CYP2C9 inhibitor in combination with a separate moderate or strong CYP3A4 inhibitor.
Maltese: • indutturi qawwija ta' CYP3A4/moderati ta' CYP2C9 (eż. carbamazepine) fil-pazjenti kollha indipendentament mill-ġenotip
English: - if you have severe liver problems.
Maltese: Ma deherx li kien hemm siponimod mhux mibdul mal-awrina.
English: Titration pack 12 film-coated tablets
Maltese: Pakkett ta' titrazzjoni bi 12-il pillola miksija b'rita
English: • Women exposed to siponimod during pregnancy are encouraged to join the pregnancy exposure programme (PRegnancy outcomes Intensive Monitoring, PRIM) that monitors outcomes of pregnancy.
Maltese: • Nisa esposti għal siponimod matul it-tqala mħeġġin jissieħbu fi programm ta' espożizzjoni waqt ittqala (Pregnancy outcomes Intensive Monitoring, PRIM) li jimmonitorja r-riżultati waqt tqala.
English: • weakness (asthenia)
Maltese: • dgħufija (astenja)
English: Until 6 hours after first dose: o Observe patients with sinus bradycardia (heart rate <55 bpm), history of first- or second-degree [Mobitz type I] AV block or a history of myocardial infarction or heart failure (patients with NYHA class I and II) for a period of 6 hours after the first dose of siponimod for signs and symptoms of bradycardia and obtain an ECG at the end of the 6-hour monitoring period.
Maltese: Sa sitt sigħat wara l-ewwel doża: o Osserva l-pazjenti bi bradikardija tas-sinus (ir-rata tat-taħbit tal-qalb <55 bpm), bi storja ta' imblokk AV tal-ewwel jew it-tieni grad [Mobitz tip I] jew bi storja ta' infart mijokardijaku jew insuffiċjenza kardijaka (pazjenti b'NYHA klassi I u II) għal tul ta' sitt sigħat wara l-ewwel doża ta' siponimod għal sinjali u sintomi ta' bradikardija u agħmel ECG fi tmiem il-perjodu ta' monitoraġġ ta' sitt sigħat.
English: - Hypersensitivity to the active substance, or to peanut, soya or any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva, jew għall-karawett, għas-soja jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1. - Sindrome tal-immunodefiċjenza.
English: If macular oedema is confirmed, your doctor may advise you to stop Mayzent treatment.
Maltese: Dan ser jippermetti identifikazzjoni ta' malajr ta' informazzjoni ġdida dwar is-sigurtà.
English: EMA/190551/2014 EMEA/H/C/000960
Maltese: EMEA/H/C/000960
English: The full EPAR for Azarga 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: IOP was measured in ‘millimetres of mercury' (mmHg).
Maltese: L-IOP tkejlet f'millimetri ta' merkurju' (mmHg).
English: • have certain heart problems;
Maltese: • ibatu minn ċerti problemi tal-qalb;
English: This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol.
Maltese: Dan tqabbel ma' bejn 5.1 u 5.6 mmHg f'dawk li kienu qed jużaw il-brinzolamide u bejn 5.7 u 6.9 mmHg f'dawk li kienu qed jużaw it-timolol.
English: This is a summary of the European public assessment report (EPAR) for Azarga.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Azarga.
English: In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga.
Maltese: Fl-ewwel studju, l-IOP naqset minn madwar 21 mmHg b'bejn 8.0 u 8.7 mmHg fil-pazjenti li kienu qed jużaw Azarga.
English: Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye).
Maltese: Azarga jintuża sabiex inaqqas il-pressjoni intraokulari (IOP, pressjoni fl-għajn).
English: The European Commission granted a marketing authorisation valid throughout the EU for Azarga on 25 November 2008.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Azarga valida madwar l-UE kollha fil-25 ta' Novembru 2008.
English: The second was a 12-month study comparing Azarga with the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients.
Maltese: It-tieni wieħed kien studju ta' 12-il xahar li qabbel Azarga mal-kombinazzjoni tat-timolol u d-dorzolamide (inibitur tal-anidrażi karbonika ieħor) f'437 pazjent.
English: Why has Azarga been approved?
Maltese: Għaliex ġie approvat Azarga?
English: Azarga has been studied in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension.
Maltese: Azarga ġie studjat f'żewġ studji prinċipali li kienu jinvolvu total ta' 960 pazjent bi glawkoma b'angolu miftuħ jew ipertensjoni okulari.
English: Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body.
Maltese: Il-brinzolamide huwa inibitur tal-anidrażi karbonika u jaħdem billi jimblokka l-enzima magħrufa bħala anidrażi karbonika, li tipproduċi joni tal-bikarbonat fil-ġisem.
English: • have hyperchloraemic acidosis (excess acid in the blood caused by too much chloride);
Maltese: • ikollhom aċidożi iperkloremika (aċidu eċċessiv fid-demm ikkawżat minn klorur żejjed);
English: In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.
Maltese: Fit-tieni studju, l-IOP kien naqas minn madwar 26 mmHg b'madwar 8.3 mmHg wara sitt xhur fiż-żewġ gruppi ta' pazjenti.
English: Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000.
Maltese: Il-brinzolamide ilu li ġie awtorizzat fl-Unjoni Ewropea (UE) bħala Azopt mill-2000.
English: It is available as eye drops.
Maltese: Jiġi bħala taqtir talgħajnejn.
English: What is the risk associated with Azarga?
Maltese: X'inhu r-riskju assoċjat ma' Azarga?
English: If it is used with another eye medicine, the different medicines should be used at least 5 minutes apart.
Maltese: Jekk tintuża f'kombinazzjoni ma' mediċina tal-għajnejn oħra, għandhom jitħallew mill-inqas 5 minuti differenza bejn il-mediċini differenti.
English: Azarga contains two active substances, brinzolamide and timolol.
Maltese: Azarga fih żewġ sustanzi attivi, il-brinzolamide u t-timolol.
English: The most common side effects with Azarga (seen in between 1 and 10 patients in 100) are blurred vision, eye pain and eye irritation.
Maltese: L-effetti sekondarji l-aktar komuni b'Azarga (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma viżjoni mċajpra, uġigħ fl-għajnejn u irritazzjoni tal-għajnejn.
English: • have severe chronic obstructive pulmonary disease (COPD, a disease causing narrowing of the airways);
Maltese: • ikollhom marda pulmonarja ostruttiva kronika (COPD, marda li twassal għal tidjiq fil-pajpijiet tan nifs);
English: The first was a six-month study comparing Azarga with brinzolamide and with timolol used on their own in 523 patients.
Maltese: L-ewwel wieħed kien studju ta' sitt xhur li qabbel Azarga malbrinzolamide u mat-timolol użati waħidhom f'523 pazjent.
English: What is Azarga?
Maltese: X'inhu Azarga?
English: • have a severe allergic rhinitis (allergy affecting the nose and airways);
Maltese: • ikollhom rinite allerġika severa (allerġija li taffettwa lill-imnifsejn u l-pajpijiet tan-nifs);
English: Azarga must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients, other beta blockers (such as some heart medicines) or sulphonamides (an antibiotic).
Maltese: Azarga ma għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għas-sustanzi attivi, għal kwalunkwe wieħed mis-sustanzi l-oħra, għall-blokkaturi tal-beta oħra (bħal xi mediċini tal-qalb) jew issulfonamidi (antibijotiku).
English: Azarga is a medicine that contains two active substances, brinzolamide and timolol.
Maltese: Azarga huwa mediċina li fiha żewġ sustanzi attivi, il-brinzolamide u t-timolol.
English: How has Azarga been studied?
Maltese: Kif ġie studjat Azarga?
English: A risk management plan has been developed to ensure that Azarga is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Azarga jintuża bl-aktar mod sigur possibbli.
English: Azarga contains benzalkonium chloride, which is known to discolour soft contact lenses.
Maltese: Azarga fih il-klorur benzalkonju, magħruf li jibdel il-kulur tal-lentijiet ta' kuntatt rotob.
English: Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Maltese: Il-pressjoni għolja tal-IOP tikkawża ħsara lir-retina (il-membrana sensittiva għad-dawl fuq wara talgħajn) u lin-nerv ottiku li jibgħat is-sinjali mill-għajn lill-moħħ.
English: It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal).
Maltese: Jintuża f'adulti li għandhom glawkoma b'angolu miftuħ (marda li tgħolli l-pressjoni fl-għajn minħabba li l-fluwidi ma jkunux jistgħu joħorġu) u f'adulti b'ipertensjoni okulari (meta l-pressjoni fl-għajn tkun ogħla minnormal).
English: The two substances work by reducing the production of the aqueous humour (the watery fluid in the eye) in different ways.
Maltese: Iż-żewġ sustanzi jaħdmu billi jnaqqsu lproduzzjoni tal-umur akweu (il-fluwidu maħlul fil-għajn) b'modi differenti.
English: What measures are being taken to ensure the safe and effective use of Azarga?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat użu sigur u effettiv ta' Azarga ?
English: Insulin Human Winthrop contains the active substance insulin human.
Maltese: Insuman Human Winthrop fih is-sustanza attiva insulina umana.
English: The active substance in Insulin Human Winthrop, insulin human, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin.
Maltese: Is-sustanza attiva f'Insulin Human Winthrop, insulina umana tiġi prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA'. hija magħmula minn batterju li rċieva ġene (DNA), li jagħmlu kapaċi jipproduċi l-insulina.
English: The European Commission granted a marketing authorisation valid throughout the EU for Insulin Human Winthrop to Sanofi-Aventis Deutschland GmbH on 17 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni valida madwar l-Unjoni Ewropea kollha għal Inuslin Human Winthrop lil Sanofi Aventis Deutschland GmbH fis-17 ta' Jannar 2007.
English: The Insulin Human Winthrop range is comprised of fast-acting insulin solutions (Insulin Human Winthrop Rapid and Insulin Human Winthrop Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insulin Human Winthrop Basal) that contains isophane insulin, and combinations of fast- and intermediateacting in various proportions (Insulin Human Winthrop Comb):
Maltese: Il-varjetajiet ta' Insulin Human Winthrop jinkludu soluzzjonijiet ta' insulina li jaħdmu malajr (Insuman Human Winthrop Rapid u Insulin Human Winthrop Infusat) u li fihom insulina solubbli, sospensjoni tal-insulina li taħdem b'mod intermedju (Insuman Human Winthrop Basal) u li fiha insulina isofana (isophane), u taħlitiet ta' proporzjonijiet diversi ta' insulina li taħdem malajr u dik li taħdem b'mod intermedju (Insulin Human Winthrop Comb):
English: In the other study, Insulin Human Winthrop Comb 25 was compared with semi-synthetic human insulin.
Maltese: Fi studju ieħor, Insuman Human Winthrop Comb 25 tqabbel ma' insulina umana semisintetika.
English: Insulin Human Winthrop can cause hypoglycaemia.
Maltese: Insulin Human Winthrop jista' jikkawża ipogliċemija.
English: Insulin Human Winthrop contains insulin in various forms: the soluble form, which acts quickly (within 30 minutes of injection), and the isophane and crystallineprotamine forms, which are absorbed much more slowly during the day, giving them a longer duration of action.
Maltese: Insulin Human Winthrop fih insulina f'diversi forom: fil-forma solubbli li taġixxi malajr (fi żmien 30 minuta mill-injezzjoni) u fil-forma isofana u dik kristallina bil-protamina, li jiġu assorbiti b'mod iktar bil-mod matul il-jum u b'hekk jaġixxu iktar fit-tul.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) INSULIN HUMAN WINTHROP RAPID INSULIN HUMAN WINTHROP BASAL INSULIN HUMAN WINTHROP COMB (15, 25, 30, 50) INSULIN HUMAN WINTHROP INFUSAT EPAR summary for the public
Maltese: http://www.emea.europa.eu/humandocs/Humans/EPAR/insulinhumanwinthrop/insulinhumanwwinthr op.htmL-EPAR sħiħ għal Insulin Human Winthrop jista' jiġi kkonsultat hawn.
English: What is Insulin Human Winthrop?
Maltese: X'inhu Insulin Human Winthrop?
English: Insulin Human Winthrop Infusat is specially prepared ready to be used in infusion pumps.
Maltese: Insulin Human Winthrop Infusat huwa speċjalment imħejji sabiex jintuża f'pompi ta' infużjoni.
English: Insulin Human Winthrop is a replacement insulin that is identical to the insulin made by the body.
Maltese: Insulin Human Winthrop jintuża bħala sostitut u huwa identiku għall-insulina prodotta mill-ġisem.
English: Other information about Insulin Human Winthrop:
Maltese: Tagħrif ieħor dear Insulin Human Winthrop:
English: Insulin Human Winthrop Rapid may also be given into a vein, but only in hospital where the patient can be closely monitored.
Maltese: Insulin Human Winthrop Rapid jista' wkoll jingħata fil-vina, iżda biss fl-isptar fejn il-pazjent ikun jista' jiġi ssorveljat mill-qrib.
English: It is supplied in vials, cartridges, or pre-filled disposable pens (OptiSet and SoloStar).
Maltese: Huwa ipprovdut bħala kunjetti, skrataċ jew pinen mimlija minn qabel (OptiSet u SoloStar).
English: What is the risk associated with Insulin Human Winthrop?
Maltese: X'inhu r-riskju assoċjat ma' Insulin Human Winthrop ?
English: For the full list of all side effects reported with Insulin Human Winthrop, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji rrappurtati b'Insulin Human Winthrop, ara l-Fuljett ta' Tagħrif.
English: The company that makes Insuman has agreed that its scientific data can be used for Insulin Human Winthrop.
Maltese: Ilkumpanija li tipproduċi Insuman qablet li l-informazzjoni xjentifika tagħha tista' tintuża għal Insulin Human Winthrop.
English: The studies measured the ‘fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours), or the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: L-istudji kollha kejlu l-livell ta' glukożju fid-demm 'fi stat ta' sawm' (imkejjel wara li ma jittiħidx ikel għal ta' l-inqas tmien sigħat) jew ta' sustanza fid-demm magħrufa bħala emoglobina glikosilata (HbA1c) li tagħti indikazzjoni fuq kemm ikun qiegħed jiġi kkontrollat tajjeb il-glukożju fid-demm.
English: Insulin Human Winthrop Rapid can also be used for the treatment of hyperglycaemic coma (coma caused by too much blood glucose [sugar]) and ketoacidosis (high levels of ketones [acids] in the blood), and to control blood glucose before, during or after an operation.
Maltese: Insulin Human Winthrop Rapid jista' wkoll jintuża għat-trattament ta' koma ipergliċemika (koma kkawżata minn eċċess ta' glukożju [zokkor] fid-demm u ketoaċidożi (livelli għoljin ta' ketoni [aċidi] fid-demm), u sabiex jikkontrolla l-glukożju fid-demm, matul jew wara operazzjoni.
English: • Insulin Human Winthrop Comb 50: 50% soluble insulin and 50% crystalline protamine insulin.
Maltese: Insulin Human Winthrop jintuża fuq pazjenti bid-dijabete li għandhom bżonn trattament bl-insulina.
English: Why has Insulin Human Winthrop been approved?
Maltese: Għaliex ġie approvat Insulin Human Winthrop?
English: What benefit has Insulin Human Winthrop shown during the studies?
Maltese: Liema benefiċċju wera Insulin Human Winthrop waqt l-istudji mwettqa?
English: The studies also looked at the number of patients who developed hypoglycaemia (low blood glucose levels).
Maltese: L-istudji eżaminaw ukoll in-numru ta' pazjenti li żviluppaw ipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: EMA/138417/2019 EMEA/H/C/000316
Maltese: EMA/138417/2019 EMA/H/C/000316
English: Xeloda is available as tablets (150 and 500 mg).
Maltese: Xeloda jiġi bħala pilloli (150 u 500 mg).
English: Further information on Xeloda can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xeloda.
Maltese: Aktar informazzjoni dwar Xeloda tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/Xeloda
English: • patients with complete absence of activity of the dihydropyrimidine dehydrogenase enzyme;
Maltese: • f'pazjenti b'assenza kompleta ta' attività tal-enzima deidroġenażi diidropirimidina;
English: The disease responded in 19 to 25% of patients treated with Xeloda, compared with 12 to 15% with the comparator combination.
Maltese: Kien hemm rispons mill-marda f'19 sa 25 % talpazjenti kkurati b'Xeloda, meta mqabbla ma' 12 sa 15 % tat-taħlita komparatura.