FrancophonIA/ELRC3.0 huggingface dataset:
English: Insulin Human Winthrop Rapid is supplied in vials containing 10 ml solution (400 IU).
Maltese: Insulin Human Winthrop Rapid huwa fornut f'kunjetti ta' 10 ml ta' soluzzjoni (500
English: Insulin Human Winthrop Infusat must NOT be mixed with any other insulin preparations.
Maltese: Insulin Human Winthrop Infusat M'GĦANDUX jitħallat ma' ebda preparazzjonijiet oħra ta' l-insulina.
English: Excipients: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Maltese: EċċipjentiI: metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Insulin Human Winthrop Rapid SoloStar 100 IU/ml solution for injection Insulin human
Maltese: Insulin Human Winthrop Rapid 100 IU/ml soluzzjoni għall-injezzjoni f'kunjett Insulina umana
English: Concernig incompatibility with other insulins, see section 6.2.
Maltese: Rigward it-taħlit jew l-inkompatibilità ma' insulini oħrajn ara sezzjoni 6.2.
English: In such cases, a new cartridge yielding a uniform suspension must be used.
Maltese: Wara li thallat, is-suspensjoni għandu jkollha dehra uniformi qisha ħalib.
English: Secondary dose adjustment
Maltese: Effetti sekondarji possibbli
English: - The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (see section 2 under “Important information about some of the ingredients of Insulin Human Winthrop Comb 30”), hydrochloric acid (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (ara sezzjoni 2 taħt ‘Tagħrif importanti dwar xi wħud mis-sustanzi ta' Insulin Human Winthrop Comb 30'), hydrochloric acid (għall-aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: Insulin Human Winthrop Comb 15 contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin.
Maltese: Insulin Human Winthrop Comb 15 jikkonsisti mis-sustanza attiva ta' l-insulina umana li hija magħmula bi proċess bijoteknoloġiku u hija identika għall-insulina li jagħmel il-ġisem innifsu.
English: After resuspension, the fluid must have a uniformly milky appearance.
Maltese: Wara t-taħlit, is-suspensjoni ta' l-insulina għandha tkun uniformement bajda qisha ħalib.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/368/001 (1 vial of 10 ml) EU/1/06/368/002 (5 vials of 10 ml)
Maltese: EU/1/06/368/001 (kunjett 1 ta' 10 ml) EU/1/06/368/002 (5 kunjetti 1 ta' 10 ml)
English: What Insulin Human Winthrop Comb 15 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 15 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Maltese: Wara li jitħallat, Insulin Human Winthrop Comb 15 huwa likwidu uniformi jixbaħ il-ħalib (suspensjoni għall-injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 30 100 IU/ml suspension for injection in a cartridge
Maltese: Insulin Human Winthrop Comb 30 100 IU/ml suspensjoni għall-injezzjoni f'skartoċċ
English: Hypoglycaemia; Sodium retention
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/368/005 (1 vial of 10 ml) EU/1/06/368/006 (5 vials of 10 ml)
Maltese: EU/1/06/368/005 (Kunjett 1 ta' 10 ml) EU/1/06/368/006 (5 kunjetti ta' 10 ml)
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 25 100 IU/ml suspension for injection in a cartridge
Maltese: Insulin Human Winthrop Comb 25 100 IU/ml suspensjoni għall-injezzjoni f'skartoċċ
English: Injection site urticaria Injection site inflammation;
Maltese: Disturbi fil metaboliżmu u n nutrizzjoni edema
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 15 100 IU/ml suspension for injection in a cartridge
Maltese: Insulin Human Winthrop Comb 15 100 IU/ml suspensjoni għall-injezzjoni ġo skartoċċ
English: What Insulin Human Winthrop Comb 50 looks like and contents of the pack After mixing, Insulin Human Winthrop Comb 50 is a uniformly milky fluid (suspension for injection), with no clumps, particles or flocculation visible.
Maltese: Wara li jitħallat, Insulin Human Winthrop Comb 50 huwa likwidu uniformi jixbaħ il-ħalib (suspensjoni għall-injezzjoni) minghajr ċapep, partikuli jew trofof viżibbli.
English: Insulin Human Winthrop Basal contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin.
Maltese: Insulin Human Winthrop Basal jikkonsisti mis-sustanza attiva ta' l-insulina umana li hija magħmula bi proċess bijoteknoloġiku u hija identika għall-insulina li jagħmel il-ġisem innifsu.
English: Insulin Human Winthrop Comb 25 contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin.
Maltese: Insulin Human Winthrop Comb 25 jikkonsisti mis-sustanza attiva ta' l-insulina umana li hija magħmula bi proċess bijoteknoloġiku u hija identika għall-insulina li jagħmel il-ġisem innifsu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/368/003 (1 vial of 10 ml) EU/1/06/368/004 (5 vials of 10 ml)
Maltese: EU/1/06/368/003 (kunjett 1 ta' 10 ml) EU/1/06/368/004 (5 kunjetti ta' 10 ml)
English: EU/1/06/368/088 EU/1/06/368/013 EU/1/06/368/014 EU/1/06/368/093 EU/1/06/368/098 EU/1/06/368/015
Maltese: EU/1/06/368/088 EU/1/06/368/013 EU/1/06/368/014
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Rapid 100 IU/ml solution for injection in a vial.
Maltese: Insulin Human Winthrop Rapid 100 IU/ml soluzzjoni għall-injezzjoni Insulina umana.
English: Side effects reported uncommonly (may affect up to 1 in 100 peopel)
Maltese: Effetti sekondarji rapportati mhux komunement (tista' taffetwa sa 1 minn kull 100 persuna)
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Basal 100 IU/ml suspension for injection in a cartridge
Maltese: Informazzjoni għall-utent Insulin Human Winthrop Basal 100 IU/ml suspensjoni għall-injezzjoni f'skartoċċ
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewrpoea għall-Mediċini http://www.ema.europa.eu
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, intermediate-acting, ATC Code: A10AC01.
Maltese: Kodiċi ATC: A10AC01.
English: - The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (see section 2 “Important information about some of the ingredients of Insulin Human Winthrop Comb 15”), hydrochloric acid (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (ara sezzjoni 2 taħt ‘Tagħrif importanti dwar xi wħud mis-sustanzi ta' Insulin Human Winthrop Comb 15'), hydrochloric acid (għall-aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: Each cartridge contains 3 ml of solution for injection, equivalent to 300 IU insulin.
Maltese: Kull skartoċċ fih 3 ml ta' soluzzjoni għall-injezzjoni, ekwivalenti għal 300 UI insulina.
English: Insulin Human Winthrop Comb 25 contains 40 IU insulin per ml.
Maltese: Insulin Human Winthrop Comb 25 qatt m'għandha tingħata fil-vina.
English: - The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (see section 2 under “Important information about some of the ingredients of Insulin Human Winthrop Comb 50”), hydrochloric acid (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide (ara sezzjoni 2 taħt ‘Tagħrif importanti dwar xi wħud mis-sustanzi ta' Insulin Human Winthrop Comb 50'), hydrochloric acid (għall-aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: NAME OF THE MEDICINAL PRODUCT Insulin Human Winthrop Comb 50 100 IU/ml suspension for injection in a cartridge
Maltese: Insulin Human Winthrop Comb 50 100 IU/ml suspensjoni għall-injezzjoni ġo skartoċċ
English: EMA/664208/2014 EMEA/H/C/004000
Maltese: EMEA/H/C/004000
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20
English: • major depression;
Maltese: • dipressjoni qawwija;
English: Duloxetine Lilly duloxetine
Maltese: Duloxetine Lilly duloxetina
English: The full EPAR and risk management plan summary for Duloxetine Lilly can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Duloxetine Lilly jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Duloxetine Lilly must not be used together with monoamine oxidase inhibitors (another group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotics).
Maltese: Duloxetine Lilly m'għandux jintuża flimkien ma' inibituri ta' monoamine oxidase (grupp ieħor ta' antidipressanti), fluvoksamina (antidipressant ieħor), jew ċiprofloksaċina jew enoksaċina (tipi ta' antibijotiċi).
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Lilly.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Duloxetine Lilly.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: • disturb ta' ansjetà ġeneralizzata (ansjetà jew nervożiżmu fit-tul dwar kwistjonijiet ta' kuljum).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Lilly on 8 December 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Duloxetine Lilly fit-8 ta' Diċembru 2014.
English: The response to treatment should be assessed regularly.
Maltese: Ir-rispons għall-kura għandu jiġi vvalutat regolarment.
English: Duloxetine Lilly is available as gastroresistant capsules (30 mg and 60 mg).
Maltese: Duloxetine Lilly huwa disponibbli bħala kapsuli gastroreżistenti (30 mg u 60 mg). ‘Gastroreżistenti' tfisser li l-kontenut tal-kapsuli jgħaddi mill-istonku mingħajr ma jitkisser sakemm jasal fl-intestini.
English: For neuropathic pain, Duloxetine Lilly has been compared with placebo in two 12-week studies in 809 diabetic adults.
Maltese: Għall-uġigħ newropatiku, Duloxetine Lilly tqabbel ma' plaċebo f'żewġ studji fuq 12-il ġimgħa fuq 809 adulti bid-dijabete.
English: Other information about Duloxetine Lilly
Maltese: Informazzjoni oħra dwar Duloxetine Lilly
English: This medicine contains the active substance duloxetine and is the same as Cymbalta, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina fiha s-sustanza attiva duloxetina u hija l-istess bħal Cymbalta, li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Maltese: Taħdem billi twaqqaf lin-newrotrasmettituri 5-hydroxytryptamine (magħruf ukoll bħala serotonina) u noradrenalina milli jerġgħu jiġu assorbiti fiċ-ċelluli nervużi fil-moħħ u fil-korda spinali.
English: Why is Duloxetine Lilly approved?
Maltese: Għaliex ġie approvat Duloxetine Lilly?
English: For major depression, the recommended dose of Duloxetine Lilly is 60 mg once a day.
Maltese: Għal dipressjoni qawwija, id-doża rakkomandata ta' Duloxetine Lilly hija ta' 60 mg darba kuljum.
English: For major depression, Duloxetine Lilly has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Maltese: Għad-dipressjoni qawwija, Duloxetine Lilly tqabbel ma' plaċebo (kura finta) fi tmien studji ewlenin li fihom ħadu sehem total ta' 2,544 pazjent.
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva f'din il-mediċina, id-duloxetina, hija inibitur tat-teħid mill-ġdid tas-serotoninanoradrenalina.
English: The most common side effects with Duloxetine Lilly (which may affect more than 1 in 10 people) are nausea (feeling sick), headache, dry mouth, somnolence (sleepiness) and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni b'Duloxetine Lilly (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nawżja (dardir), uġigħ ta' ras, ħalq xott, sonnolenza (ngħas) u sturdament.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Maltese: Għal disturb ta' ansjetà ġeneralizzata, id-doża rakkomandata tal-bidu hija ta' 30 mg darba kuljum, iżda d-doża tista' tiżdied għal 60, 90 jew 120 mg skont ir-rispons tal-pazjent.
English: For generalised anxiety disorder, Duloxetine Lilly has been compared with placebo in five studies involving a total of 2,337 patients.
Maltese: Għad-disturb ta' ansjetà ġeneralizzata, Duloxetine Lilly tqabbel ma' plaċebo f'ħames studji li fihom ħadu sehem total ta' 2,337 pazjent.
English: The company that makes Cymbalta has agreed that its scientific data can be used for Duloxetine Lilly (‘informed consent').
Maltese: Il-kumpanija li tagħmel Cymbalta aċċettat li d-dejta xjentifika tagħha tista' tintuża għal Duloxetine Lilly (‘kunsens infurmat').
English: The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Duloxetine Lilly, including 288 patients with a history of repeated episodes of depression for up to five years.
Maltese: Iż-żewġ studji l-oħra ħarsu lejn it-tul ta' żmien biex issintomi jerġgħu jitfaċċaw f'pazjenti li inizjalment kienu rrispondew għal Duloxetine Lilly, fosthom 288 pazjent bi storja ta' episodji ripetuti ta' dipressjoni sa ħames snin.
English: A risk management plan has been developed to ensure that Duloxetine Lilly is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Duloxetine Lilly jintuża bl-aktar mod sigur possibbli.
English: The fifth study looked at how long it took for symptoms to return in 429 patients who had initially responded to Duloxetine Lilly.
Maltese: Il-ħames studju ħares lejn it-tul ta' żmien biex is-sintomi jerġgħu jitfaċċaw f'429 pazjent li inizjalment kienu rrispondew għal Duloxetine Lilly.
English: What are the risks associated with Duloxetine Lilly?
Maltese: X'inhuma r-riskji assoċjati ma' Duloxetine Lilly?
English: In the two studies where the approved dose of Duloxetine Lilly was compared with placebo, Duloxetine Lilly was more effective.
Maltese: Fiż-żewġ studji fejn id-doża approvata ta' Duloxetine Lilly ġiet imqabbla ma' plaċebo, Duloxetine Lilly kien aktar effettiv.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Maltese: • uġigħ minħabba newropatija periferali tad-dijabete (ħsara lin-nervituri fl-estremitajiet li tista' sseħħ f'pazjenti bid-dijabete);
English: Duloxetine Lilly is a medicine that is used to treat adults with the following diseases:
Maltese: Duloxetine Lilly huwa mediċina li tintuża għall-kura ta' adulti bil-mard li ġej:
English: Duloxetine Lilly was shown to be more effective than placebo at treating the disorder and preventing symptoms returning.
Maltese: Duloxetine Lilly intwera li kien aktar effettiv minn plaċebo fil-kura tad-disturb u fil-prevenzjoni ta' rikaduta.
English: Treatment must not be started in patients with uncontrolled hypertension (high blood pressure), because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Maltese: Il-kura m'għandhiex tinbeda f'pazjenti bi pressjoni għolja mhux ikkontrollata, minħabba riskju ta' kriżi ipertensiva (pressjoni għolja tad-demm f'daqqa u perikoluża).
English: In patients who respond to Duloxetine Lilly, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Maltese: F'pazjenti li jirrispondu għal Duloxetine Lilly, il-kura għandha titkompla għal diversi xhur biex tiġi evitata rikaduta, jew għal żmien itwal f'pazjenti li fil-passat kellhom perjodi ripetuti ta' dipressjoni.
English: For the full list of all side effects reported with Duloxetine Lilly, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Duloxetine Lilly, ara l-fuljett ta' tagħrif.
English: Most patients will need to take 60 mg per day.
Maltese: Pazjenti li għandhom ukoll dipressjoni qawwija għandhom jibdew b'60 mg darba kuljum.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Maltese: Għal uġigħ newropatiku tad-dijabete, id-doża rakkomandata hija ta' 60 mg kuljum iżda xi pazjenti jistgħu jeħtieġu doża ogħla ta' 120 mg kuljum.
English: Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Maltese: Peress li dawn in-newrotrasmettituri huma involuti fiż-żamma ta' burdata elevata u jnaqqsu ssensazzjoni ta' uġigħ, meta jiġi mblukkat l-assorbiment mill-ġdid tagħhom fiċ ċelloli nervużi dan jista' jtejjeb is-sintomi ta' dipressjoni, ansjetà u uġigħ newropatiku.
English: In patients who respond to Duloxetine Lilly, treatment should continue for several months, to prevent the disorder coming back.
Maltese: F'pazjenti li jirrispondu għal Duloxetine Lilly, il-kura għandha titkompla għal diversi xhur, biex tiġi evitata rikaduta.
English: It is available as tablets in the following strengths: 150 /5/12.5 mg; 300/5/12.5 mg; 300/5/25 mg; 300/10/12.5 mg; and 300/10/25 mg.
Maltese: 5 mg; 300/5/12.5 mg; 300/5/25 mg; 300/10/12.5 mg; u 300/10/25 mg.
English: The full EPAR for Rasitrio 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: Aliskiren is a renin inhibitor.
Maltese: L-aliskiren hija inibitur tar-renina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasitrio on 22 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rasitrio fit-22 ta' Novembru 2011.
English: Amlodipine is a calcium channel blocker.
Maltese: L-amlodipina hija sustanza li timblokka l-kanali tal-kalċju.
English: EPAR summary for the public aliskiren / amlodipine / hydrochlorothiazide
Maltese: Sommarju tal-EPAR għall-pubbliku aliskiren / amlodipina (amlodipine) / idroklorotijażide (hydrochlorothiazide)
English: Reductions of 28.2 mmHg, 30.6 mmHg and 30.8 mmHg were seen for aliskiren plus hydrochlorothiazide, aliskiren plus amlodipine and amlodipine plus hydrochlorothiazide respectively.
Maltese: Deher tnaqqis ta' 28.2 mmHg, ta' 30.6 mmHg u ta' 30.8 mmHg għall-aliskiren flimkien mal-idroklorotijażide, għallaliskiren flimkien mal-amlodipina u għall-amlodipina flimkien mal-idroklorotijażide rispettivament.
English: This is a summary of the European public assessment report (EPAR) for Rasitrio.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Rasitrio.
English: Hydrochlorothiazide is a diuretic.
Maltese: L-idroklorotijażide hija dijuretika.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: Angiotensin I jiġi konvertit flormon angiotensin II, li huwa vażokostrittur qawwi (sustanza li ddejjaq il-vini).
English: In a main study in 1,191 patients with moderate or severe hypertension, Rasitrio combinations containing the three active substances were compared with combinations containing only two active substances: aliskiren plus amlodipine, amlodipine plus hydrochlorothiazide, and aliskiren plus hydrochlorothiazide.
Maltese: Fi studju ewlieni fuq 1,191 pazjent bl-ipertensjoni moderata jew severa, il-kombinazzjonijiet ta' Rasitrio bit-tliet sustanzi attivi kienu mqabbla ma' kombinazzjonijiet b'żewġ sustanzi attivi biss: laliskiren flimkien mal-amlodipina, l-amlodipina flimkien mal-idroklorotijażide, u l-aliskiren flimkien malidroklorotijażide.
English: What is Rasitrio?
Maltese: X'inhu Rasitrio?
English: Rasitrio contains three active substances, aliskiren, amlodipine, and hydrochlorothiazide.
Maltese: Rasitrio fih tliet sustanzi attivi, l-aliskiren, l-amlodipina u l-idroklorotijażide.
English: Why has Rasitrio been approved?
Maltese: Għaliex ġie approvat Rasitrio?
English: The combination of these three active substances reduces blood pressure more than either medicine acting alone.
Maltese: Il-kombinazzjoni ta' dawn it-tliet sustanzi attivi tnaqqas il-pressjoni tad-demm aktar milli kull waħda mill-mediċini taġixxi weħidha.
English: What is the risk associated with Rasitrio?
Maltese: X'inhu r-riskju assoċjat ma' Rasitrio?
English: Rasitrio is a medicine that contains the active substances aliskiren, amlodipine and hydrochlorothiazide.
Maltese: Rasitrio huwa mediċina li fiha s-sustanzi attivi aliskiren, amlodipina u idroklorotijażide.
English: After eight weeks, patients treated with Rasitrio had an average reduction in sitting systolic blood pressure of 37.4 mmHg.
Maltese: Wara tmien ġimgħat, il-pazjenti li kienu rċevew kura b'Rasitrio kellhom tnaqqis medju fil-pressjoni tad-demm sistolika waqt li kienu bilqiegħda ta' 37.4 mmHg.
English: By blocking the activity of renin, levels of both, angiotensin I and angiotensin II, fall.
Maltese: Billi jimblokka l-attività tar-renina, il-livelli kemm ta' angiotensin I kif ukoll ta' angiotensin II, jaqgħu.
English: Rasitrio must not be used in people who are hypersensitive (allergic) to aliskiren, amlodipine, or hydrochlorothiazide, to any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group that includes amlodipine) or sulphonamide (includes hydrochlorothiazide).
Maltese: Rasitrio ma għandux jintuża fuq persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal aliskiren, amlodipina jew idroklorotijażide, għal xi sustanza oħra tal-mediċina jew għal sustanzi oħra li ġejjin minn diidropiridin (grupp li jinkludi l-amlodipina) jew sulfonamide (jinkludi l-idroklorotijażide).
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter.
Maltese: Hija timblokka l-kanali speċjali preżenti fuq il-wiċċ taċ-ċelluli magħrufa bħala kanali tal-kalċju li minnhom normalment jidħlu l-joni tal-kalċju.
English: How has Rasitrio been studied?
Maltese: Kif ġie studjat Rasitrio?
English: For the full list of all side effects reported with Rasitrio, see the package leaflet.
Maltese: L-effetti sekondarji l-aktar komuni b'Rasitrio huma ipotensjoni u sturdament.
English: Ref. EMEA/306731/2008
Maltese: EMEA/545123/2008
English: London, 26 June 2008 Doc.
Maltese: Londra, 26 ta' Ġunju 2008 Doc.
English: Aflunov is a ‘prepandemic' vaccine.
Maltese: Aflunov huwa vaċċin ‘prepandemiku'.
English: What is Aflunov?
Maltese: X'inhu Aflunov?
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Is-CHMP normalment jieħu sa 210 ijiem biex jevalwa applikazzjoni ġdida.