FrancophonIA/ELRC3.0 huggingface dataset:
English: Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being treated with an antidepressant.
Maltese: Informazzjoni minn provi kliniċi wrew riskju ikbar ta' mġiba suwiċidali f'adulti żgħażagħ (taħt il-25 sena) b'kondizzjonijiet psikjatriċi li kienu kkurati b'antidipressant.
English: MM/YYYY
Maltese: L-immaniġġjar
English: (>3 times the upper limit of the normal range) Hepatic failure*(1)
Maltese: (> il-limitu ta' fuq tal-meded normali u ≤3 darbiet il-limitu ta' fuq tal-medda normali).
English: A meta-analysis of placebocontrolled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
Maltese: Metaanaliżi ta' provi kliniċi b' antidipressanti ikkontrollati bi plaċebo f'pazjenti adulti b'disturbi psikjatriċi juru żieda fir-riskju ta' mġiba suwiċidali b'antidipressanti meta mqabbla ma' plaċebo, f'pazjenti ta' taħt il-25 sena.
English: Binding studies indicate that agomelatine has no effect on monoamine uptake and no affinity for α, β adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors.
Maltese: Studji fuq it-twaħħil jindikaw li agomelatine m'għandu l-ebda effett fuq kemm il-monoamine jaqbad mar-riċetturi u ma għandux affinita għar-riċetturi α, β adrenergic, histaminergic, cholinergic, dopaminergic u benzodiazepine.
English: A specific controlled, 3-week trial has been conducted in patients suffering from major depressive disorder and insufficiently improved with paroxetine (a SSRI) or venlafaxine (a SNRI).
Maltese: Saret prova speċifika, ikkontrollata ta' 3 ġimgħat f'pazjenti li kienu qed isofru minn disturb dipressiv maġġuri u li ma sarx titjib suffiċjenti fihom b'paroxetine (SSRI) jew venlafaxine (SNRI).
English: Discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking.
Maltese: Is-sintomi ta' diskontinwazzjoni jinkludu: sturdament, tnemnim, disturbi fl-irqad, aġitazzjoni jew ansjetà,
English: In two other trials, it was not possible to draw any conclusions because the active controls, paroxetine or fluoxetine, failed to differentiate from placebo.
Maltese: F'żewġ provi oħra, ma kienx possibbli li tilħaq konklużjonijiet minħabba li l-kontrolli attivi, paroxetine jew fluoxetine fallew milli juru differenza mill-plaċebo.
English: - if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).
Maltese: jekk qed tieħu fluvoxamine (mediċina oħra li tintuża għall-kura tad-dipressjoni) jew ciprofloxacin (antibijotiku).
English: Nausea
Maltese: Parasteżija
English: Management of overdose should consist of treatment of clinical symptoms and routine monitoring.
Maltese: L-immaniġġjar ta' doża eċċessiva jrid jikkonsisti f'kura ta' sintomi kliniċi u osservazzjoni ta' rutina.
English: Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin.
Maltese: Agomelatine jżid il-ħruġ tan-noradrenaline u tad-dopamine b'mod speċifiku fil-parti ta' quddiem tal-moħħ u ma għandux influwenza fuq il-livelli extraċellulari ta' serotonin.
English: Experience with agomelatine in overdose has indicated that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise have been reported.
Maltese: Esperjenza b'agomelatine f'dożi eċċessivi indikat li ġew irrapportati epigastralġija, ngħas, għeja, aġitazzjoni, ansjetà, tensjoni, sturdament, ċijanożi jew telqa.
English: In clinical trials among children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed compared to those treated with placebo (see section 4.2).
Maltese: (l-aktar aggressjoni, imġiba konfrontali u rabja) kienu osservati iktar frekwenti meta mqabbla ma dawk li kienu kkurati bil-plaċebo (ara sezzjoni 4.2).
English: Headache
Maltese: Epatite
English: Steady state volume of distribution is about 35 l and plasma protein binding is 95% irrespective of the concentration and is not modified with age and in patients with renal impairment but the free fraction is doubled in patients with hepatic impairment.
Maltese: 95% irrispettivament mill-konċentrazzjoni u mhuwiex modifikat biż-żmien u f'pazjenti b'disturbi fil-kliewi iżda l-frazzjoni libera tirdoppja f'pazjenti b'indeboliment fil-fwied.
English: Clinical efficacy and safety
Maltese: GĦAMLA KWALITATTIVA
English: The pattern of liver damage is predominantly hepatocellular with increased serum transaminases, which usually return to normal levels on cessation of agomelatine.
Maltese: It-tendenza tal-ħsara fil-fwied hija predominantament epatoċellulari b'żieda fit-transaminażi tas-serum li normalment tirritorna għal-livelli normali wara li jitwaqqaf agomelatine.
English: 5 How to store Valdoxan Contents of the pack and other information
Maltese: Kif taħżen Valdoxan Kontenut tal-pakkett u informazzjoni oħra
English: - If you have bipolar disorder, have experienced or if you develop manic symptoms (a period of abnormally high excitability and emotions) talk to your doctor before you start taking this medicine or before you continue with this medicine (see also under “Possible side effects” in section 4).
Maltese: - Jekk int għandek disturb bipolari, esperjenzajt jew tiżviluppa sintomi manijaċi (perjodu t'eċċitament jew emozzjonijiet qawwija anormali) kellem lit-tabib tiegħek qabel tibda tieħu din il-mediċina jew qabel ma tkompli tieħu din il-mediċina (ara wkoll taħt ‘Effetti sekondarji possibbli' f'sezzjoni 4).
English: In a specific study involving cirrhotic patients with chronic mild (Child-Pugh type A) or moderate (Child-Pugh type B) liver impairment, exposure to agomelatine 25 mg was substantially increased (70times and 140-times, respectively), compared to matched volunteers (age, weight and smoking habit) with no liver failure (see section 4.2, 4.3 and 4.4).
Maltese: Fi studju speċifiku li involva pazjenti kirrotiċi b'indeboliment fil-fwied kroniku minuri (Child-Pugh tip A) u moderat (Child-Pugh Tip B), l-esponiment għall-agomelatine 25 mg żdied sostanzjalment (70 darba u 140
English: Each film-coated tablet contains 25 mg of agomelatine.
Maltese: Kull pillola miksija b'rita fiha 25 mg t'agomelatine.
English: These side effects include: - Very common side effects (may affect more than 1 in 10 people) :headache - Common side effects (may affect up to 1 in 10 people): dizziness, sleepiness (somnolence), difficulty in sleeping (insomnia), feeling sick (nausea), diarrhoea, constipation, abdominal pain, back pain, tiredness, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, vomiting, weight increased.
Maltese: - Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): sturdament, ngħas (aptit torqod), diffikultà biex torqod (insomnia), tħossok marid (dardir), dijarea, stitikezza, uġigħ addominali,
English: Agomelatine failed to differentiate from placebo in two trials where the active control, paroxetine or fluoxetine showed assay sensitivity.
Maltese: Agomelatine falla milli juri xi differenza mill-plaċebo f'żewġ provi fejn il-kontroll attiv, paroxetine jew fluoxetine wera sensittività mkejla.
English: Superiority (2 trials) or non-inferiority (4 trials) has been shown in six out of seven efficacy trials in heterogeneous populations of depressed adult patients versus SSRI/SNRI (sertraline, escitalopram, fluoxetine, venlafaxine or duloxetine) The anti-depressive effect was assessed with the HAMD-17 score either as primary or secondary endpoint.
Maltese: Superjorità (2 provi) jew nuqqas ta' inferjorità (4 provi) intwerew f'sitta minn seba' provi tal-effikaċja f'popolazzjonijiet eteroġeniċi ta' pazjenti adulti b'dipressjoni meta mqabbla ma' SSRI/SNRI (sertraline,
English: No effect of agomelatine is documented in patients ≥75 years, therefore agomelatine should not be used by patients in this age group (see also sections 4.2 and 5.1).
Maltese: Ma ġie ddokumentat l-ebda effett ta' agomelatine f'pazjenti ≥ 75 sena, għalhekk agomelatine ma għandux jintuża minn pazjenti f'dan il-grupp ta' età (ara wkoll sezzjonijiet 4.2 u 5.1).
English: Following discontinuation of Valdoxan therapy liver function tests should be repeated until serum transaminases return to normal.
Maltese: Wara l-waqfien tal-kura b'Valdoxan, it-testijiet tal-funzjoni tal-fwied għandhom jiġu ripetuti sakemm it transaminażi fis-serum tirritorna għan-normal.
English: Weight decreased* * Frequency estimated from clinical trials for adverse reactions detected from spontaneous report (1) Few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors.
Maltese: Tnaqqis fil-piż* * Frekwenza stmata mill-provi kliniċi għar-reazzjonijiet avversi mikxufin minn rapport spontanju
English: Erythematous rash Face oedema and angioedema*
Maltese: Ħolm ikrah*
English: Level of sodium
Maltese: Livell ta' sodium
English: Efficacy was also observed in more severely depressed patients (baseline HAM-D ≥ 25) in all positive placebo-controlled trials.
Maltese: L-effikaċja kienet ukoll osservata f'pazjenti li kellhom dipressjoni iktar severa (baseline HAM-D ≥ 25) fi provi kollha pożittivi kkontrollati bi plaċebo.
English: The symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Maltese: valur, telf tal-interess f'attivitajiet favoriti, disturbi fl-irqad, sens li tħossok sejjer lura, sens ta' anzjetà, bdil fil-piż.
English: The frequency of benign mammary fibroadenomas observed in the rat was increased with high exposures (60-fold the exposure at the therapeutic dose) but remains in the range of that of controls.
Maltese: Il-frekwenza ta' fibroadenomas beninn tas-sider ġiet osservata fil-far u żdiedet b'esponimenti għoljin (60 darba iktar tal-esponiment tad-doża terapewtika) imma tibqa' fil-livell tal-kontrolli.
English: Fatigue
Maltese: Anzjetà
English: BATCH NUMBER Batch
Maltese: TAGĦRIF
English: Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika disponibbli fuq l-annimali wriet tneħħija ta' agomelatine/metaboliti fil-ħalib (ara sezzjoni 5.3). Riskju lit-trabi tat-twelid/tfal ma jistax jiġi eskluż.
English: Valdoxan with alcohol
Maltese: Valdoxan ma' alkoħol
English: Treatment duration
Maltese: TAL-PRODOTT MEDIĊINALI
English: Cases of liver injury, including hepatic failure (few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors), elevations of liver enzymes exceeding 10 times upper limit of normal, hepatitis and jaundice have been reported in patients treated with agomelatine in the post-marketing setting (see section 4.8).
Maltese: Każijiet ta' korriment tal-fwied, inkluż indeboliment tal-fwied (b'mod eċċezzjonali ġew irrapportati xi każijiet b'riżultat fatali jew bi trapjant tal-fwied f'pazjenti b'fatturi ta' riskju tal-fwied), żidiet tal-enżimi tal fwied li jaqbżu 10 darbiet l-ogħla limitu tan-normal, ta' epatite u suffejra ġew irrapportati f'pazjenti kkurati b'agomelatine fl-ambjent ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility, embryofoetal development and pre- and post natal development.
Maltese: Ma kien osservat l-ebda effett ta' agomelatine fuq l-imġiba, il-funzjoni viżwali u riproduttiva ta' frieħ ta'
English: There were mild non dose dependent decreases in body weight related to the pharmacological properties and some minor effects on male reproductive tract without any impairment on reproductive performances.
Maltese: Kien hemm tnaqqis ħafif mhux dipendenti fuq id-doża fil-piż tal-ġisem relatat mal-karatteristiċi farmakoloġiċi u xi effetti minuri fuq il-passaġġ riproduttiv tal-irġiel mingħajr ebda indeboliment fuq il prestazzjonijiet riproduttivi.
English: However, only limited clinical data on the use of agomelatine in depressed patients with severe or moderate renal impairment with major depressive episodes is available.
Maltese: Madankollu, l-informazzjoni klinika disponibbli hija limitata dwar l-użu ta' agomelatine f'pazjenti b'dipressjoni li jbatu minn disturbi fil-kliewi serji jew moderati u b'episodji dipressivi maġġuri.
English: EMA/476557/2019 EMEA/H/C/004161
Maltese: EMA/536777/2019 EMA/H/C/004161
English: Further information on Edistride can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Edistride.
Maltese: ema.europa.eu/medicines/human/EPAR/Edistride.
English: Edistride received a marketing authorisation valid throughout the EU on 9 November 2015.
Maltese: Edistride ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-9 ta' Novembru 2015.
English: Other information about Edistride
Maltese: Informazzjoni oħra dwar Edistride
English: Edistride contains the active substance dapagliflozin.
Maltese: Edistride fih is-sustanza attiva dapagliflożin.
English: Both combinations reduced HbA1c levels by 0.52 percentage points after 52 weeks.
Maltese: Iżżewġ kombinazzjonijiet naqqsu l-livelli ta' HbA1c b'0.52 punt perċentwali wara 52 ġimgħa.
English: The active substance in Edistride, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: Is-sustanza attiva f'Edistride, id-dapagliflożin, taħdem billi timblokka l-azzjoni ta' proteina fil-kliewi li tissejjaħ kotrasportatur 2 ta' sodju-glukożju (SGLT2).
English: In two studies involving 1,648 patients with type 1 diabetes whose blood sugar was not controlled well enough on insulin alone, adding Edistride 5 mg decreased HbA1c levels after 24 hours by 0.37% and by 0.42% more than adding placebo.
Maltese: F'żewġ studji li involvew 1,648 pazjent bid-dijabete tat-tip 1 li z-zokkor fid-demm tagħhom ma kienx ikkontrollat tajjeb biżżejjed bl-insulina waħidha, iż-żieda ta' Edistride 5 mg naqqset il-livelli ta' HbA1c wara 24 siegħa b'0.37 % u b'0.42 % aktar miż-żieda tal-plaċebo.
English: Edistride is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Maltese: Edistride jiġi bħala pilloli (5 u 10 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Maltese: Studju fit-tul, li involva aktar minn 17,000 pazjent bid-dijabete tat-tip 2, ħares lejn l-effetti ta' dapagliflożin fuq mard kardjovaskulari (tal-qalb u taċ-ċirkolazzjoni).
English: In a study involving 814 patients with type 2 diabetes, Edistride used in combination with metformin was at least as effective as a sulphonylurea (another type of diabetes medicines) used with metformin.
Maltese: Fi studju li involva 814-il pazjenti bid-dijabete tat-tip 2, Edistride użat flimkien mal-metformina kien tal-inqas effettiv daqs sulfonilurea (tip ta' mediċina oħra kontra d-dijabete) użat mal-metformina.
English: This authorisation was based on the authorisation granted for Forxiga in 2012.
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Forxiga fl-2012.
English: For type 2 diabetes, the dose of Edistride is 10 mg once a day.
Maltese: Għad-dijabete tat-tip 2, id-doża ta' Edistride hija 10 mg darba kuljum.
English: Edistride was found effective in several studies in patients with type 2 and type 1 diabetes.
Maltese: Edistride nstab li hu effettiv f'diversi studji b'pazjenti bid-dijabete tat-tip 2 u tat-tip 1.
English: The company that markets Edistride will provide information on precautions to prevent diabetic ketoacidosis in patients with type 1 diabetes, including a patient alert card, and a guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Maltese: Il-kumpanija li tqiegħed Edistride fis-suq se tipprovdi informazzjoni dwar prekawzjonijiet biex tiġi evitata ketoaċidożi dijabetika f'pazjenti bid-dijabete tat-tip 1, inkluż kard ta' twissija tal-pazjent, u gwida għall-pazjenti u għal min jieħu ħsiebhom, kif ukoll gwida għall-professjonisti fil-qasam tal-kura tas-saħħa, inkluża lista ta' kontroll tal-preskrivent.
English: What are the risks associated with Edistride?
Maltese: X'inhuma r-riskji assoċjati ma' Edistride?
English: In type 1 diabetes, Edistride is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control the diabetes well enough.
Maltese: Fid-dijabete tat-tip 1, Edistride jintuża mal-insulina f'pazjenti b'piż żejjed (indiċi tal-massa tal-ġisem ta' mill-inqas 27 kg/m2) meta l-insulina waħidha ma tikkontrollax id-dijabete biżżejjed.
English: Edistride's common side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary infection, and are considered manageable.
Maltese: L-effetti sekondarji komuni ta' Edistride kienu relatati mal-mod kif taħdem il-mediċina, bħal żieda flinfezzjonijiet ġenitali u, sa ċertu punt inqas, infezzjonijiet fl-apparat tal-awrina, u jitqiesu maniġġabbli.
English: As for all medicines, data on the use of Edistride are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Edistride hija ssorveljata kontinwament.
English: In two studies involving 840 patients with type 2 diabetes, Edistride when used alone decreased HbA1c levels by 0.66 percentage points more than placebo (a dummy treatment) after 24 weeks.
Maltese: HbA1c b'0.66 punt perċentwali aktar mill-plaċebo (kura finta) wara 24 ġimgħa.
English: What measures are being taken to ensure the safe and effective use of Edistride?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Edistride?
English: Side effects reported with Edistride are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Edistride huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: In four other studies involving 2,370 patients, adding Edistride to other diabetes medicines decreased HbA1c levels by 0.54-0.68 percentage points more than adding placebo after 24 weeks.
Maltese: HbA1c b'0.54-0.68 punt perċentwali aktar miż-żieda tal-plaċebo wara 24 ġimgħa.
English: For the full list of side effects and restrictions with Edistride, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Edistride, ara l-fuljett ta' tagħrif.
English: Edistride (dapagliflozin)
Maltese: Kif jintuża Edistride?
English: The most common side effect in patients with type 1 diabetes (which may affect up to 1 in 10 people) is genital infection, especially in women and a common side effect (which may affect up to 1 in 100 people) is diabetic ketoacidosis.
Maltese: L-effett sekondarju l-aktar komuni f'pazjenti bid-dijabete tat-tip 1 (li jista' jaffettwa sa persuna 1 minn 10 persuni) huwa l-infezzjoni ġenitali, speċjalment fin-nisa u effett sekondarju komuni (li jista' jaffettwa sa persuna 1 f'100 persuna) huwa l-ketoaċidożi dijabetika.
English: By blocking the action of SGLT2, dapagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Maltese: Billi timblokka l-azzjoni ta' SGLT2, iddapagliflożin tikkawża lill-kilwa biex tgħaddi aktar glukożju fl-urina, u b'hekk jitnaqqsu l-livelli ta' glukożju fid-demm.
English: The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-livell ta' emoglobina glikosilata (HbA1c), li jagħti indikazzjoni ta' kemm il-glukożju fid-demm ikun ikkontrollat tajjeb.
English: In addition, beneficial reductions in weight and blood pressure occurred in patients treated with Edistride.
Maltese: Barra minn hekk, seħħ tnaqqis benefiċjarju fil-piż u fil-pressjoni tad-demm f'pazjenti kkurati b'Edistride.
English: Edistride is a diabetes medicine used for adults whose condition is not controlled well enough.
Maltese: Edistride huwa mediċina kontra d-dijabete użata għall-adulti li l-kundizzjoni tagħhom ma tkunx ikkontrollata tajjeb biżżejjed.
English: The full EPAR for Dasselta 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: The European Commission granted a marketing authorisation valid throughout the European Union for Dasselta on 28 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Dasselta fil-28 ta' Novembru 2011.
English: Dasselta is a medicine containing the active substance desloratadine.
Maltese: Dasselta huwa mediċina li fiha s-sustanza attiva desloratadina.
English: This is a summary of the European public assessment report (EPAR) for Dasselta.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Dasselta.
English: Dasselta is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Maltese: Dasselta jintuża biex itaffi s-sintomi tar-rinite allerġika (infjammazzjoni fil-passaġġi nażali kkawżata minn allerġija, pereżempju minn riħ tal-ħuxlief (hay fever) jew allerġija għal akari tat-trab (dust mites) jew urtikarja (kundizzjoni fil-ġilda kkawżata minn allerġija, b'sintomi li jinkludu ħakk u ħorriqija).
English: What are the benefits and risks of Dasselta?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Dasselta?
English: What is Dasselta?
Maltese: X'inhu Dasselta?
English: The active substance in Dasselta, desloratadine, is an antihistamine.
Maltese: Is-sustanza attiva f'Dasselta, id-desloratadina, hija sustanza antistaminika.
English: Because Dasselta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Maltese: Billi Dasselta huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jiddeterminaw ilbijoekwivalenza tiegħu mal-mediċina ta' referenza Aerius.
English: Other information about Dasselta
Maltese: Għal xiex jintuża Dasselta?
English: Because Dasselta is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Dasselta huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, ilbenefiċċju u r-riskju tagħha huma meqjusa analogi għal dawk tal-mediċini ta' referenza.
English: Dasselta is a ‘generic medicine'.
Maltese: Il-mediċina tinkiseb biss b'riċetta ta' tabib.
English: This means that Dasselta is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
Maltese: Dasselta huwa ‘mediċina ġenerika' Dan ifisser li Dasselta jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Aerius.
English: When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Maltese: jkunu imblokkati, l-istamina ma tkunx tista' jkollha effett, u dan iwassal għal tnaqqis fis-sintomi talallerġija.
English: How does Dasselta work?
Maltese: Kif jaħdem Dasselta?
English: Therefore, the CHMP's view was that, as for Aerius, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Aerius, ilbenefiċċji huma akbar mir-riskji identifikati.