FrancophonIA/ELRC3.0 huggingface dataset:
English: Unless given by a central venous line, dilute to a concentration of 0.1 - 0.2 mg/ml before use (see section 6.2 for details of compatible solutions)
Maltese: Ħlief jekk ma jingħatax minn linja venuża ċentrali, iddilwixxi għal konċentrazzjoni ta' 0.1-0.2 mg/ml qabel l-użu (ara sezzjoni 6.2 għad-dettalji dwar soluzzjonijiet kompatibbli)
English: Rates can be increased by increments of 0.5 or 1 mg every 15 minutes.
Maltese: Ir-rati jistgħu jiżdiedu b'inkrementi ta' 0.5 jew 1 mg kull 15-il minuta.
English: Nicardipine solution for injection contains nicardipine hydrochloride, which belongs to a group of medicines called calcium channel blockers.
Maltese: Nicardipine soluzzjoni għall-injezzjoni fih in-nicardipine hydrochloride, li jagħmel parti minn grupp ta' mediċini li jisimhom imblokkaturi tal-kanal tal-kalċju.
English: In animal studies, administration of verapamil and intravenous dantrolene has caused fatal ventricular fibrillation.
Maltese: Fi studji fuq l-annimali, l-għoti ta' verapamil u ta' dantrolene ġol-vini kkawża fibrillazzjoni ventrikulari fatali.
English: Co-administration of calcium channel blockers with itraconazole has shown an increased risk of adverse events, in particular oedema due to a decreased metabolism of the calcium channel blocker in the liver.
Maltese: L-għoti flimkien ta' imblokkaturi tal-kanal tal-kalċju ma' itraconazole wera riskju akbar ta' episodji avversi, b'mod partikulari edema minħabba metaboliżmu mnaqqas fil-fwied tal-imblokkatur tal-kanal tal-kalċju.
English: Not known - thrombocytopenia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: The most frequent events are headache, dizziness, peripheral oedema, palpitations and flushing
Maltese: L-iktar avvenimenti frekwenti huma uġigħ ta' ras, sturdament, edema periferali, palpitazzjonijiet u fwawar.
English: Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Maltese: Studji kliniċi ta' nicardipine ma inkludewx numri suffiċjenti ta' pazjenti li kellhom 65 sena u aktar biex ikun determinat jekk jirrispondux b'mod differenti minn individwi iżgħar.
English: A switch can also be made to oral nicardipine 20mg capsules at dosage of 60 mg/day in 3 daily doses, or to nicardipine 50 mg extended-release tablets, at dosage of 100mg/day, in 2 daily doses.
Maltese: Tista' wkoll issir bidla għal nicardipine orali f'kapsuli ta' 20 mg b'dożaġġ ta' 60 mg/jum fi 3 dożi ta' kuljum, jew għal nicardipine pilloli li jerħu fuq tul ta' żmien ta' 50 mg, b'dożaġġ ta' 100 mg/ jum, f'2 dożi ta' kuljum.
English: Ischaemic cardiovascular disease.
Maltese: Mard kardjovaskulari iskemiku.
English: Nicardipine is a second generation slow calcium channel inhibitor, and belongs to the phenyl-dihydropyridine group.
Maltese: Nicardipine hu inibitur tal-kanal tal-kalċju li jaħdem bil-mod u li hu tat-tieni ġenerazzjoni, u jagħmel parti mill-grupp phenyl-dihydropyridine.
English: The medicine will be injected slowly into a vein.
Maltese: Il-mediċina se tiġi injettata bil-mod ġo vina.
English: Respiratory, thoracic and mediastinal disorders Not known - pulmonary oedema* Gastrointestinal disorders
Maltese: Mhux magħruf - edema pulmonari*
English: Initial dose: Treatment should start with the continuous administration of nicardipine at a rate of 3-5 mg/h for 15 minutes.
Maltese: Il-kura għandha tinbeda bl-għoti kontinwu ta' nicardipine b'rata ta' 3-5 mg/siegħa għal 15-il minuta.
English: - Dantrolene (used to treat long-term muscle stiffness) - Beta-blockers (used to treat high blood pressure and heart conditions) such as propranolol, atenolol and metoprolol - Medicines used to control seizures, such as carbamazepine , phenobarbitone, primidone and phenytoin - Baclofen (used to treat muscle spasms) - Medicines used to control the body's immune system, such as tacrolimus, sirolimus and ciclosporin - Itraconazole (used to treat certain types of fungal infection) - Rifampicin (used to treat tuberculosis and certain other types of infection) - Alpha-blockers (used to treat high blood pressure, or prostate problems in men) such as doxazosin,
Maltese: Itraconazole (użat għall-kura ta' ċerti tipi ta' infezzjonijiet fungali) Rifampicin (użat għall-kura tat-tuberkulożi u ta' ċerti tipi ta' infezzjonijiet oħra) Imblokkaturi alpha (użati għall-kura ta' pressjoni għolja tad-demm, jew problemi fil-prostata flirġiel) bħal doxazosin, prazosin u terazosin
English: 4.5 Interaction with other medicinal products and other forms of interaction Enhancement of negative inotropic effect
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Other medicines and Nicardipine solution for injection
Maltese: Mediċini oħra u Nicardipine soluzzjoni għall-injezzjoni
English: Common - flushing Not known - erythema
Maltese: Mhux magħruf - flebite
English: Nicardipine has a greater selectivity for L-type calcium channels in vascular smooth muscle than cardiac myocytes.
Maltese: Nicardipine għandu selettività akbar għall-kanali tal-kalċju tattip L fil-muskoli lixxi vaskulari milli mill-majoċiti tal-qalb.
English: Concomitant medications which could potentiate the antihypertensive effect of nicardipine include baclofen, alphablockers, tricyclic antidepressants, neuroleptics, opiods and amifostine Decrease of antihypertensive effect
Maltese: Medikazzjonijiet oħra li jistgħu jsaħħu l-effett ta' kontra l-pressjoni għolja ta' nicardipine jinkludu baclofen, imblokkaturi alpha, antidipressanti triċikliċi, newrolettiċi, opjojdi u amifostine.
English: Nicardipine in combination with intravenous corticosteroids and tetracosactide (except for hydrocortisone used as replacement therapy in Addison's disease) may cause a decrease in the antihypertensive effect Inhalational anaesthetics
Maltese: L-għoti ta' nicardipine flimkien ma' kortikosterojdi u tetracosactide fil-vini (ħlief għal hydrocortisone li jintuża bħala terapija ta' sostituzzjoni fil-marda ta' Addison) jista' jikkawża tnaqqis fl-effett ta' kontra lpressjoni għolja.
English: Its action is produced mainly on arterial smooth muscle.
Maltese: L-azzjoni tiegħu tiġi prodotta l-aktar fil-muskolu lixx arterjali.
English: Administered by systemic route, nicardipine is a potent vasodilator which diminishes total peripheral resistance and lowers blood pressure.
Maltese: Mogħti mir-rotta sistemika, nicardipine hu vażodilatatur potenti li jnaqqas ir-reżistenza periferali totali u jbaxxi l-pressjoni tad-demm.
English: The use of nicardipine for severe pre-eclampsia during the third trimester of pregnancy could potentially produce an undesirable tocolytic effect which could potentially interfere with the spontaneous induction of labour.
Maltese: L-użu ta' nicardipine għal preeklampsija severa matul it-tielet trimestru tat-tqala jista' potenzjalment jipproduċi effett tokolitiku mhux mixtieq li jista' potenzjalment jinterferixxi mal-induzzjoni spontanja tal-ħlas.
English: Due to the possible risk of pulmonary oedema or excessive decrease in blood pressure, caution should be taken if magnesium sulphate is used concomitantly (see section 4.4) CYP3A4 inducers and inhibitors
Maltese: Minħabba r-riskju possibbli ta' edema pulmonari jew ta' tnaqqis eċċessiv fil-pressjoni tad-demm, wieħed għandu joqgħod attent jekk il-magnesium sulphate jintuża fl-istess ħin (ara sezzjoni 4.4)
English: In laboratory animals, overdosage also resulted in reversible hepatic function abnormalities, sporadic focal hepatic necrosis and progressive atrio-ventricular conduction block.
Maltese: Fl-annimali tal-laboratorju, dożaġġ eċċessiv irriżulta wkoll f'anormalitajiet riversibbli fil-funzjoni tal-fwied, nekrożi fokali tal-fwied sporadika u imblokk progressiv tal-konduzzjoni atrijoventrikulari.
English: Not known - phlebitis
Maltese: Disturbi fil-qalb
English: Maintenance dose: When the target pressure is reached, the dose should be reduced progressively, usually to between 2 and 4 mg/h, to maintain the therapeutic efficacy.
Maltese: Meta l-pressjoni tad-demm fil-mira tintlaħaq, id-doża għandha titnaqqas progressivament, normalment bejn 2 u 4 mg/siegħa, biex tinżamm l-effikaċja terapewtika.
English: If you are taking beta-blockers
Maltese: Jekk qed tieħu imblokkaturi beta
English: Nicardipine has been reported to increase the plasma levels of digoxin in pharmacokinetic studies.
Maltese: Nicardipine ġie rrappurtat li żied il-livelli ta' digoxin fil-plażma waqt studji farmakokinetiċi.
English: Common - lower limb oedema, palpitations Common - hypotension, tachycardia Not known -atrioventricular block, angina pectoris
Maltese: Komuni - edema fir-riġlejn, palpitazzjonijiet Komuni - pressjoni baxxa, takikardija Mhux magħruf - imblokk atrijoventrikulari, anġina pectoris
English: The majority of undesirable effects are the consequence of the vasodilator effects of nicardipine.
Maltese: Il-maġġoranza tal-effetti mhux mixtieqa huma l-konsegwenza tal-effetti vażodilatatorji ta' nicardipine.
English: The speed of administration must be accurately controlled by the use of an electronic syringe driver or a volumetric pump.
Maltese: Il-veloċità tal-għoti għandha tkun ikkontrollata bi preċiżjoni bl-użu ta' driver elettroniku tas-siringa jew pompa volumetrika.
English: A hypertensive episode which often accompanies a stroke is not an indication for emergency antihypertensive therapy.
Maltese: Episodju ta' pressjoni għolja li ħafna drabi jakkumpanja l-puplesija mhuwiex indikazzjoni għal terapija ta' emerġenza ta' kontra lpressjoni għolja.
English: Elderly patients may be more sensitive to nicardipine effects because of impaired renal and/or hepatic function.
Maltese: Pazjenti anzjani jistgħu jkunu aktar sensittivi għall-effetti ta' nicardipine minħabba indeboliment filfunzjoni tal-kliewi u/jew tal-fwied.
English: Studies involving either a single dose, or administration 3 times daily for 3 days, have shown that less than 0.03% of unchanged nicardipine is recovered in the urine in humans after oral or intravenous administration.
Maltese: Studji li jinvolvu jew doża waħda, jew l-għoti 3 darbiet kuljum għal 3 ijiem, urew li inqas minn 0.03% ta' nicardipine mhux mibdul jiġi rkuprat flawrina fil-bnedmin wara l-għoti mill-ħalq jew minn ġol-vini.
English: After 30 minutes, depending on the effect observed, the rate should be increased or decreased by increments of 0.5 mg/h.
Maltese: Wara 30 minuta, skont l-effett osservat, ir-rata għandha tiġi miżjuda jew imnaqqsa b'inkrementi ta' 0.5 mg/siegħa.
English: Intravenous nicardipine at high doses has been reported to worsen portal vein hypertension and portal-systemic collateral blood flow index in cirrhotic patients.
Maltese: Ġie rrappurtat li nicardipine mogħti ġol-vini f'dożi għoljin jiggrava l-pressjoni għolja fil-vina portali u lindiċi tal-fluss tad-demm kollaterali portal sistemiku f'pazjenti b'ċirrożi.
English: The most abundant metabolite in human urine is the glucuronide of the hydroxy form, which is formed by the oxidative cleaving of the N-methylbenzyl moiety and the oxidation of the pyridine ring.
Maltese: L-aktar metabolit abbundanti fl-awrina talbniedem hu l-glucuronide tal-għamla hydroxy, li hu ffurmat mill-cleaving ossidattiv tal-komponent Nmethylbenzyl u l-ossidazzjoni taċ-ċirku pyridine.
English: Common - dizziness
Maltese: TAL-PRODOTT
English: Nicardipine is not dialyzable.
Maltese: Nicardipine ma jitneħħiex bid-dijalisi.
English: Transition to an oral antihypertensive agent: discontinue nicardipine or titrate downward while appropriate oral therapy is established.
Maltese: It-transizzjoni għal sustanza orali ta' kontra l-pressjoni għolja: waqqaf nicardipine jew ittitra 'l isfel meta tkun stabbilita terapija orali xierqa.
English: Rapid pharmacologic reductions in blood pressure may produce systemic hypotension and reflex tachycardia.
Maltese: Tnaqqis farmakoloġiku mgħaġġel fil-pressjoni tad-demm jista' jipproduċi pressjoni baxxa sistemika u takikardija riflessa.
English: • Severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contraindicated
Maltese: • Preeklampsija severa, meta sustanzi oħra ta' kontra l-pressjoni għolja li jingħataw ġol-vina ma jkunux rakkomandati jew huma kontraindikati.
English: The safety and efficacy of nicardipine IV has not been tested in controlled clinical trials in infants or children, thus special care is required in this population (refer to section 4.2)
Maltese: Is-sigurtà u l-effikaċja ta' nicardipine IV ma ġewx ittestjati fi provi kliniċi kkontrollati fi trabi jew tfal, u għalhekk hi meħtieġa attenzjoni speċjali f'din il-popolazzjoni (ara sezzjoni 4.2).
English: Skin and subcutaneous tissue disorders
Maltese: FIS-SUQ Biex timtela mill-pajjiż partikolari
English: Renal Impairment
Maltese: Tqala u treddigħ
English: Limited clinical data suggests that the effects of inhaled anaesthetics (e.g. isoflurane, sevoflurane and enflurane) on nicardipine appear to be moderate.
Maltese: Dejta klinika limitata tissuġġerixxi li l-effetti tal-anestetiċi li jittieħdu man-nifs eż.
English: At steady state, Cmax and AUC were significantly higher and clearance significantly lower in subjects with mild/moderate renal dysfunction compared with in subjects with normal renal function.
Maltese: Fl-istat fiss, is-Cmax u l-AUC kienu ogħla b'mod sinifikanti u t-tneħħija kienet iktar baxxa b'mod sinifikanti f'individwi b'disfunzjoni ħafifa/moderata tal-kliewi meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: Common - nausea, vomiting Not known - paralytic ileus
Maltese: Komuni - dardir, rimettar Mhux magħruf - ileus paralitiku
English: Limited data suggest that nicardipine, as other calcium channel blockers, enhances neuromuscular block possibly by acting at the post-junctional region.
Maltese: Dejta limitata tissuġġerixxi li nicardipine, bħal imblokkaturi oħrajn tal-kanal tal-kalċju, itejjeb l-imblokk newromuskolari possibbilment billi jaġixxi fis-sit ta' wara l-ġogi.
English: The combination of a calcium channel inhibitor and dantrolene is therefore potentially dangerous.
Maltese: Għalhekk, l-għoti flimkien ta' inibitur tal-kanal tal-kalċju u ta' dantrolene hu potenzjalment perikoluż.
English: How to store Nicardipine solution for injection Contents of the pack and other information
Maltese: Kif jidher Nicardipine soluzzjoni għall-injezzjoni u l-kontenut tal-pakkett
English: Co-administration of CYP3A4 enzyme-inhibiting agents (e.g. cimetidine, itraconazole and grapefruit juice) may cause an increase in the plasma concentrations of nicardipine.
Maltese: L-għoti flimkien ta' sustanzi li jinibixxu l-enzimi ta' CYP 3A4 (eż. cimetidine, itraconazole u meraq talgrejpfrut) jista' jikkawża żieda fil-konċentrazzjonijiet ta' nicardipine fil-plażma.
English: London, 12 September 2008 EMEA/CHMP/496102/2008
Maltese: Londra, 12 ta' Settembru 2008 EMEA/CHMP/496116/2008
English: Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: Artikolu 29(4) tad-Direttiva 2001/83/KE, kif emendata.
English: The Rapporteur was Dr Pierre Demolis (FR) as Rapporteur and Co-Rapporteur(s) was Dr Ingemar Persson (SE).
Maltese: Ir-Rapporteur kien Dr Pierre Demolis (FR) bħala Rapporteur u Ko-Rapporteur(s) kien Dr Ingemar Persson (SE).
English: The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Slovenia, Slovak Republic and United Kingdom.
Maltese: L-Istat Membru tar-Riferiment kien l-Iżvezja u lIstati Membri Konċernati kienu l-Awstrija, il-Belġju, il-Bulgarija, ir-Repubblika Ċeka, id-Danimarka, lEstonja, Spanja, il-Finlandja, Franza, l-Ungerija, l-Irlanda, l-Iżlanda, l-Italja, il-Litwanja, il-Lussemburgu, ilLatvija, l-Olanda, in-Norveġja, il-Portugall, ir-Rumanija, is-Slovenja, ir-Repubblika Slovakka u r-Renju Unit.
English: Significant difference has been identified with regard to clinical safety.
Maltese: Ġiet identifikata differenza sinifikanti fir-rigward tas-sigurtà klinika.
English: The arbitration procedure started on 19 March 2008 with the adoption of a list of questions.
Maltese: Il-proċedura ta' arbitraġġ bdiet fid-19 ta' Marzu 2008 bl-adozzjoni ta' lista ta' mistoqsijiet.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Activelle and associated names International Non-Proprietary Name (INN): Estradiol and norethisterone acetate
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT SKOND L-ARTIKOLU 29(4)1 GĦAL Activelle u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): Estradiol u norethisterone acetate
English: Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets is a continuous combined hormone replacement therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.
Maltese: Activelle u ismijiet assoċjati, estradiol 0.5mg u norethisterone acetate 0.1 mg pilloli miksijin b'rita huwa kura ta' sostituzzjoni tal-ormoni (HRT) kombinata kontinwa għal sintomi ta' nuqqas ta' estroġenu f'nisa aktar minn sena wara l-menopawża tagħhom.
English: Novo Nordisk A/S submitted applications for mutual recognition of Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets on the basis of the marketing authorisation granted by Sweden on 3 August 2007.
Maltese: Novo Nordisk A/S ippreżentat applikazzjonijiet għar-rikonoxximent reċiproku ta' Activelle u ismijiet assoċjati, estradiol 0.5mg u norethisterone acetate 0.1 mg pilloli miksijin b'rita fuq il-bażi talawtorizzazzjoni tat-tqegħid fis-suq mogħtija mill-Iżvezja fit-3 ta' Awwissu 2007.
English: Sweden referred the reasons for disagreement to the EMEA on 3 March 2008.
Maltese: L-Iżvezja irriferiet irraġunijiet għan-nuqqas ta' ftehim lill-EMEA fit-3 ta' Marzu 2008.
English: This refers to endometrial safety of Activelle 0.5 mg/0.1 mg, which had been insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/CHMP/021/97 rev 1) and this was considered to be of serious public health concern.
Maltese: Din tirreferi għas-sigurtà endometrijali ta' Activelle 0.5 mg/0.1 mg, li ma ntwerietx biżżejjed skont il-linja gwida tas-CHMP għall-prodotti HRT (EMEA/CHMP/021/97 rev 1) u dan tqies bħala ta' tħassib serju għas-saħħa pubblika.
English: The Marketing Authorisation Holder provided written explanations on 5 May 2008.
Maltese: IdDetentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta spjegazzjonijiet bil-miktub fil-5 ta' Mejju 2008.
English: During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Activelle and associated names, that the objections raised by France and Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Matul il-laqgħa tiegħu ta' Ġunju 2008, is-CHMP, fid-dawl tad-dejta ġenerali ippreżentata u tad-diskussjoni xejntifika fi ħdan il-Kumitat, kien tal-opinjoni li l-proporzjon bejn il-benefiċċju/riskju kien wieħed favorevoli għal Activelle u ismijiet assoċjati, li l-oġġezzjonijiet imqajma minn Franza u mill-Ġermanja ma għandhomx jimpedixxu l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju tal-Karatteristiċi tal-Prodott, tikketta u fuljett ta' tagħrif tal-Istat Membru ta' Riferiment għandhom jiġu emendati.
English: The final opinion was converted into a Decision by the European Commission on 11 September 2008.
Maltese: L-opinjoni finali inqelbet f'Deċiżjoni mill-Kummissjoni Ewropea fil-11 ta' Settembru 2008.
English: Esbriet pirfenidone
Maltese: Esbriet pirfenidon
English: The full EPAR for Esbriet 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 summary of the opinion of the Committee for Orphan Medicinal Products for Esbriet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għal Prodotti Mediċinali Orfni għal Esbriet jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Other information about Esbriet
Maltese: Informazzjoni oħra dwar Esbriet
English: Esbriet is available as capsules (267 mg) and tablets (267, 534 and 801 mg) that are taken at mealtimes.
Maltese: Esbriet jiġi bħala kapsuli (267 mg) u pilloli (267, 534 u 801 mg) li jittieħdu fil-ħinijiet tal-ikel.
English: Because the number of patients with IPF is low, the disease is considered ‘rare', and Esbriet was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 November 2004.
Maltese: Minħabba li n-numru ta' pazjenti li għandhom IPF huwa wieħed baxx, il-marda hija kkunsidrata bħala ‘rari', u fis-16 ta' Novembru 2004, Esbriet ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari).
English: Esbriet contains the active substance pirfenidone.
Maltese: Esbriet fih is-sustanza attiva pirfenidon.
English: This is a summary of the European public assessment report (EPAR) for Esbriet.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Esbriet.
English: The most common side effects with Esbriet during clinical studies were nausea (feeling sick), rash, tiredness, diarrhoea, dyspepsia (heartburn), loss of appetite, headache and photosensitivity reactions (sunburn-like reactions following exposure to light).
Maltese: L-effetti sekondarji l-aktar komuni b'Esbriet matul l-istudji kliniċi kienu nawżja (tħossok ma tiflaħx), raxx, għeja, dijarea, dispepsja (ħruq ta' stonku), nuqqas ta' aptit, uġigħ ta' ras u reazzjonijiet ta' fotosensittività (reazzjonijiet qishom ħruq tax-xemx wara esponiment għad-dawl).
English: The first study also compared two doses of Esbriet (399 mg and 801 mg three times a day).
Maltese: L-ewwel studju qabbel ukoll żewġ dożi ta' Esbriet (339 mg u 801 mg tliet darbiet kuljum).
English: Esbriet is a medicine used to treat adults with mild to moderate idiopathic pulmonary fibrosis (IPF).
Maltese: Esbriet jintuża fil-kura ta' adulti b'fibrożi pulmonari idjopatika (IPF) ħafifa sa moderata.
English: The CHMP also noted the lack of effective alternative treatments.
Maltese: Is-CHMP innota wkoll in-nuqqas ta' kuri alternattivi effettivi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Esbriet on 28 February 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Esbriet valida fl-Unjoni Ewropea kollha fit-28 ta' Frar 2011.
English: Why is Esbriet approved?
Maltese: Għaliex ġie approvat Esbriet?
English: The higher dose results from the first study, combined with the results of the second study (which involved the same higher dose), showed that the average reduction in FVC was 8.5% for patients taking Esbriet compared with 11% for patients taking placebo.
Maltese: Ir-riżultati tad-doża ogħla mill-ewwel studju, ikkombinati mar-riżultati tat-tieni studju (li fih intużat l-istess doża ogħla), urew li t-tnaqqis medju fl-FVC kien ta' 8.5% għall-pazjenti li kienu qed jieħdu Esbriet meta mqabbel ma' 11% għall-pazjenti li kienu qed jieħdu l-plaċebo.
English: The dose of Esbriet is increased steadily, starting with 267 mg three times a day in the first week, 534 mg three times a day in the second week and 801 mg three times a day from the third week onwards.
Maltese: Id-doża ta' Esbriet tiżdied b'mod gradwali, tibda b'267 mg tliet darbiet kuljum fl-ewwel ġimgħa, 534 mg tliet darbiet kuljum fit-tieni ġimgħa u 801 mg tliet darbiet kuljum mit-tielet ġimgħa 'l quddiem.