FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Procoralan
Maltese: “Tiħux Procoralan”).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/001-007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/05/316/001-007
English: Procoralan may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Maltese: Sewqan u tħaddim ta' magni Procoralan jista' jikkaġunalek fenomeni viżivi mudwali temporanji (luminożità temporanja fil-kamp viżiv,
English: Children Procoralan is not intended for use in children and adolescents younger than 18 years.
Maltese: Procoralan mhuwiex intenzjonat sabiex jintuża fi tfal u adoloxxenti ta' inqas minn 18-il sena.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people rare: may affect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Maltese: komuni ħafna: tista' taffettwa aktar minn persuna 1 minn kull 10 komuni: tista' taffettwa sa persuna 1 minn kull 10 mhux komuni: tista' taffettwa sa persuna 1 minn kull 100 rari: tista' taffettwa sa persuna 1 minn kull 1000 rari ħafna: tista' taffettwa sa persuna 1 minn kull 10000
English: NAME OF THE MEDICINAL PRODUCT Procoralan 7.5 mg film-coated tablets ivabradine
Maltese: Procoralan 7.5 mg pilloli miksija b'rita ivabradine
English: Talk to your doctor or pharmacist before taking Procoralan - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Maltese: - jekk tbati minn sintomi ta' fibrillazzjoni atrijali (rata tal-polz fi stat mistrieħ eċċezzjonalment għolja (aktar minn 110 taħbita fil-minuta) jew irregolari, mingħajr l-ebda raġuni evidenti, li jagħmilha diffiċli biex titkejjel, - jekk riċentament kellek puplesija (attakk ċerebrali), - jekk tbati ħafif għal moderat minn pressjoni baxxa, - jekk tbati minn pressjoni tad-demm mhux ikkontrollata, speċjalment wara bidla fil-kura tiegħek kontra l-pressjoni għolja, - jekk tbati minn insuffiċjenza severa tal-qalb jew kollass tal-qalb b'anormalità tal-ECG imsejħa 'imblokk tal-fergħa bundle',
English: One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Maltese: U KWANTITATTIVA Pillola waħda miksija b'rita fiha 7.5 mg ivabradine (ekwivalenti għal 8.085 mg ivabradine hydrochloride)
English: NAME OF THE MEDICINAL PRODUCT Procoralan 5 mg film-coated tablets ivabradine
Maltese: Procoralan 5 mg pilloli miksija b'rita ivabradine
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Procoralan 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Maltese: F'xi każijiet (eż. jekk inti anzjan), it-tabib tiegħek jista' jordnalek nofs id-doża, jiġifieri nofs pillola ta' 5 mg ta' Procoralan 5 mg (li tikkorrispondi għal 2.5 mg ta' ivabradine) filgħodu u nofs pillola ta' 5 mg filgħaxija.
English: Verapamil, diltiazem or strong CYP 3A4 inhibitors were received by 7.1% of patients during the study.
Maltese: ivabradine (2.1% fil-grupp tal-plaċebo). 7.1% tal-pazjenti ngħataw verapamil, diltiazem jew inibituri qawwija ta' CYP 3A4 waqt l-istudju.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride)
Maltese: - Is-sustanza attiva hi ivabradine (bħala hydrochloride) Procoralan 5 mg: pillola waħda miksija b'rita fiha 5 mg ivabradine (ekwivalenti għal 5.390 mg ivabradine hydrochloride)
English: Procoralan contains lactose
Maltese: Jekk tinsa tieħu Procoralan
English: josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2) - Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5) - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)
Maltese: - Użu flimkien ma' impedituri taċ-ċitokromu qawwi P450 3A4 bħal mediċini kontra l-fungi tat-tip azole (ketoconazole, itraconazole), antibijotiċi tat-tip macrolide (clarithromycin, erythromycin per os, josamycin, telithromycin), impedituri HIV protease (nelfinavir, ritonavir) u nefazodone (ara sezzjoni 4.5 u 5.2) - Użu flimkien ma' verapamil jew diltiazem li huma inibituri moderati ta' CYP3A4 bi proprjetajiet ta' tnaqqis fir-rata tat-taħbit tal-qalb (ara sezzjoni 4.5)
English: How to take Procoralan
Maltese: Procoralan.
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation:
Maltese: Ivabradine m'għandux effett fuq il-ħin biex jgħaddi l-istimulu intrakardijaku, fuq il-kontrazzjoni (l-ebda effett negattiv inotropiku) u lanqas fuq ir-ripolarizzazzjoni ventrikulari:
English: (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os,
Maltese: sertindole) - mediċini kontra l-malarja (bħal mefloquine jew halofantrine) - erythromycin ġol-vini (antibijotiku)
English: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals;
Maltese: - fi studji kliniċi elettrofiżjoloġiċi, ivabradine la kellu effett fuq il-ħin atrijuventrikulari jew intraventrikulari biex jgħaddi l-istimulu u lanqas fuq l-intervall QT ikkoreġut;
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Procoralan in one or more subsets of the paediatric population in the treatment of chronic heart failure (see section 4.2 for information on paediatric use).
Maltese: Procoralan f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-kura ta' indeboliment kroniku tal qalb (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Procoralan with food and drink Avoid grapefruit juice during treatment with Procoralan.
Maltese: Evita li tieħu il-meraq tal-grejpfrut meta tkun qed tieħu Procoralan.
English: - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
Maltese: Imblokk AV 1 grad (ECG prolongat fl-interval PQ) Żieda fl-extra sistoli ventrikulari Fibrillazzjoni atrijali
English: Packaging Content Package size
Maltese: Ippakkjar Kontenut Daqs tal-pakkett
English: MA (EU) number
Maltese: <Numru ta' l-EU> <Numru tal-MA>
English: Immediate Packaging Pack size
Maltese: Mnejn jingħata Il-pakkett li jmiss mal-prodott
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: The full EPAR for Respreeza 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: Other information about Respreeza
Maltese: Informazzjoni oħra dwar Respreeza
English: The decrease in lung density after 24 months was around 2.6 g/l in patients who received Respreeza, compared with a decrease of around 4.2 g/l in patients receiving placebo.
Maltese: It-tnaqqis fid-densità tal-pulmuni wara 24 xahar kien madwar 2.6 g/l f'pazjenti li rċevew Respreeza, meta mqabbel ma' tnaqqis ta' madwar 4.2 g/l f'pazjenti li rċevew plaċebo.
English: What are the risks associated with Respreeza?
Maltese: X'inhuma r-riskji assoċjati ma' Respreeza?
English: This is a summary of the European public assessment report (EPAR) for Respreeza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Respreeza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Respreeza on 20 August 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Respreeza valida fl-Unjoni Ewropea kollha fl-20 ta' Awwissu 2015.
English: Respreeza contains the active substance human alpha1-proteinase inhibitor.
Maltese: Respreeza fih is-sustanza attiva inibitur alpha1-proteinase tal-bniedem.
English: The infusion should last around 15 minutes.
Maltese: L-infużjoni għandha ddum madwar 15-il minuta.
English: The most common side effects with Respreeza (which may affect up to 1 in 10 people) are dizziness, headache, dyspnoea (shortness of breath) and nausea.
Maltese: L-effetti sekondarji l-aktar komuni b'Respreeza (li jistgħu jaffettwaw sa persuna 1 minn 10) huma sturdament, uġigħ ta' ras, dispnea (qtugħ ta' nifs) u nawżja.
English: The active substance in Respreeza, human alpha1-proteinase inhibitor, is a natural protein in the blood which protects lung tissue from damage.
Maltese: Is-sustanza attiva f'Respreeza, l-inibitur alpha1-proteinase tal-bniedem, hija proteina naturali fiddemm li tipproteġi t-tessut tal-pulmun mill-ħsara.
English: Respreeza is available as a powder and solvent to be made into a solution for infusion (drip) into a vein.
Maltese: Respreeza jiġi bħala trab u solvent sabiex jiġu magħmulin f'soluzzjoni għal infużjoni (dripp) ġol-vina.
English: The recommended dose of Respreeza is 60 mg per kilogram body weight, given once a week.
Maltese: Id-doża rakkomandata ta' Respreeza hija 60 mg għal kull kilogramm tal-piż tal-ġisem, mogħtija darba fil-ġimgħa.
English: Why is Respreeza approved?
Maltese: Għaliex ġie approvat Respreeza?
English: Respreeza has been shown to slow down lung damage in one main study involving 180 patients with lung damage due to alpha1-proteinase inhibitor deficiency.
Maltese: Respreeza wera li jnaqqas il-ħsara fil-pulmun fi studju ewlieni li involva 180 pazjent bi ħsara fil-pulmun minħabba defiċjenza tal-inibitur alpha1-proteinase.
English: Respreeza human alpha1-proteinase inhibitor
Maltese: Sommarju tal-EPAR għall-pubbliku inibitur alpha1-proteinase tal-bniedem
English: In the study, Respreeza was compared with placebo (a dummy treatment) and the main measure of effectiveness was the decrease in lung density.
Maltese: Fl-istudju, Respreeza tqabbel ma' plaċebo (kura finta) u l-kejl ewlieni tal-effikaċja kien it-tnaqqis fid-densità tal-pulmuni.
English: For the full list of all side effects and restrictions with Respreeza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Respreeza, ara l-fuljett ta' tagħrif.
English: Respreeza is a medicine used in adults with alpha1-proteinase inhibitor deficiency, an inherited disorder that can cause lung problems such as increasing shortness of breath and which may also affect the liver.
Maltese: Respreeza huwa mediċina li tintuża f'adulti b'defiċjenza tal-inibitur alpha1-proteinase, disturb ereditarju li jista' jikkawża problemi fil-pulmun bħal żieda fil-qtugħ ta' nifs u li jista' wkoll jaffettwa l-fwied.
English: The company that markets Respreeza will carry out a further study to assess whether an increased dose of 120 mg/kg may lead to improved effects compared with the currently recommended dose.
Maltese: Il-kumpanija li tqiegħed Respreeza fis-suq ser twettaq studju ulterjuri biex tevalwa jekk doża miżjuda ta' 120 mg/kg tistax twassal għal titjib fl-effetti meta mqabbel mad-doża attwalment rakkomandata.
English: Allergic reactions were the main safety concern with Respreeza, but advice on how to manage this risk has been included in the product information.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Respreeza.
English: The main study with Respreeza showed that the medicine is effective at slowing down the damage to the lungs in patients with alpha1-proteinase inhibitor deficiency, and this effect is considered relevant for patients with severe disease.
Maltese: L-istudju ewlieni b'Respreeza wera li l-mediċina hija effettiva fit-tnaqqis tal-ħsara lill-pulmuni f'pazjenti b'defiċjenza tal-inibitur alpha1-proteinase, u dan l-effett ġie kkunsidrat rilevanti għal pazjenti b'marda severa.
English: The first infusion should be given under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Maltese: Tinkiseb mid-demm tal-bniedem u taħdem billi tissostitwixxi il-proteina li hija nieqsa f'pazjenti b'defiċjenza tal-inibitur alpha1-proteinase.
English: The full EPAR for Emselex 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: EPAR summary for the public darifenacin
Maltese: Sommarju tal-EPAR għall-pubbliku darifenaċina
English: • severe liver problems;
Maltese: • problemi gravi fil-fwied;
English: It blocks a receptor called the ‘muscarinic M3 receptor'.
Maltese: Din timblokka riċettur imsejjaħ ‘riċettur tal-muscarinic M3'.
English: The active substance in Emselex, darifenacin, is an anticholinergic medicine.
Maltese: Is-sustanza attiva Emselex, id-darifenaċina, hija mediċina antikolinerġika.
English: Emselex was used at various doses (from 3.75 mg to 30 mg a day) and compared with placebo (a dummy treatment) or with tolterodine (another medicine used in this condition).
Maltese: Emselex intuża b'dożi differenti (minn 3.75 mg sa 30 mg kuljum) u tqabbel ma' plaċebo (trattament finta) jew mat-tolterodina (mediċina oħra użata għal din il-kundizzjoni).
English: This is a summary of the European public assessment report (EPAR) for Emselex.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Emselex.
English: Emselex has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder.
Maltese: Emselex ġie eżaminat f'erba' studji ewlenin fuq total ta' 2,078 pazjent taż-żewġ sessi b'sintomi talbużżieqa iperattiva.
English: The CHMP concluded that Emselex showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome.
Maltese: Is-CHMP ikkonkluda li Emselex wera effikaċja simili għal dik ta' mediċini antikolinerġiċi oħra użati għattrattament tas-sindromu tal-bużżieqa iperattiva.
English: It is available as prolongedrelease tablets (7.5 mg and 15 mg).
Maltese: Jiġi f'pilloli tondi b'rilaxx imtawwal (7.5 mg u 15 mg).
English: After 12 weeks of treatment, patients receiving Emselex 7.5 mg or 15 mg had 8.8 (68%) or 10.6 (77%) fewer episodes of incontinence per week, respectively, and patients receiving placebo had 7 or 7.5 (54 or 58%) fewer episodes per week.
Maltese: (77%) episodji ta' inkontinenza fil-ġimgħa rispettivament, filwaqt li fil-pazjenti ttrattati bi plaċebo t-tnaqqis irriżulta f'7 jew 7.5 (54 jew 58%) episodji.
English: • toxic megacolon (a very serious complication of colitis).
Maltese: • megacolon tossiku (kumplikazzjoni serja ħafna tal-kolite).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emselex on 22 October 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Emselex valida fl-Unjoni Ewropea kollha fit-22 ta' Ottubru 2004.
English: The recommended starting dose of Emselex is 7.5 mg once a day.
Maltese: Id-doża tal-bidu rakkomandata ta' Emselex hi 7.5 mg darba kuljum.
English: What is Emselex?
Maltese: X'inhu Emselex?
English: • severe ulcerative colitis (severe inflammation of the gut causing ulcers and bleeding);
Maltese: • kolite ulċerattiva severa (infjammazzjoni severa tal-musrana l-kbira li tikkawża ulċeri u fsada);
English: Emselex is a medicine that contains the active substance darifenacin.
Maltese: Emselex huwa mediċina li fiha s-sustanza attiva darifenaċina.
English: • uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment);
Maltese: • glawkoma b'angolu dejjaq mhux ikkontrollata (żieda fil-pressjoni fl-għajnejn li tkun reżistenti għat trattament);
English: • myasthenia gravis (a disease causing muscle weakness);
Maltese: • mijastenija gravi (marda li tikkawża dgħjufija fil-muskoli);
English: For patients requiring greater symptom relief, the dose may be increased to 15 mg.
Maltese: Għal pazjenti li jeħtieġu li ssintomi jittaffewlhom aktar, id-doża tista' tiżdied għal 15 mg.
English: It is used to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.
Maltese: Emselex jintuża għattrattament tal-inkontinenza urġenti (nuqqas ta' kontroll għal għarrieda fuq il-ħruġ tal-awrina), taż-żieda fil-frekwenza (bżonn frekwenti li tagħmel l-awrina) u tal-urġenza urinarja (stimolu għal għarrieda li tagħmel l-awrina) li huma assoċjati mas-sindromu.
English: Emselex must not be taken by patients who are also taking medicines that could affect the way that Emselex is broken down in the body, such as protease inhibitors (used to treat HIV infection, such as ritonavir), or ketoconazole or itraconazole (used to treat fungal infections).
Maltese: Emselex m'għandux jintuża minn pazjenti li jkunu qed jieħdu wkoll mediċini li jistgħu jaffettwaw il-mod kif Emselex jitkisser fil-ġisem, bħall-inibituri protiżi (użati għat-trattament tal-infezzjoni mill-HIV, bħarritonavir) jew il-ketokonażol jew l-itrakonażol (użati biex jiġu trattati infezzjonijiet fungali).
English: Why has Emselex been approved?
Maltese: Għaliex ġie approvat Emselex?
English: Emselex is used in adults with overactive bladder syndrome.
Maltese: Emselex jintuża f'adulti bis-sindromu tal-bużżieqa tal-awrina iperattiva.
English: How has Emselex been studied?
Maltese: Kif ġie studjat Emselex?
English: What is the risk associated with Emselex?
Maltese: X'inhu r-riskju assoċjat ma' Emselex?
English: Other information about Emselex
Maltese: Għal xiex jintuża Emselex?
English: The most common side effects with Emselex (seen in more than 1 patient in 10) are dry mouth and constipation.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Emselex (li dehru f'aktar minn pazjent 1 minn kull 10) huma ħalq xott u stitikezza.
English: The application was withdrawn before ‘day 120'.
Maltese: L-applikazzjoni ġiet irtirata fil-‘jum 120'.
English: Withdrawal of the marketing authorisation application for Comfyde (carisbamate) EMA/32301/2010
Maltese: Irtirar tal-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq għal Comfyde (carisbamate) EMA/393215/2010
English: Comfyde is a medicine that contains the active substance carisbamate.
Maltese: Comfyde huwa mediċina li fih s-sustanza attiva carisbamate.
English: The company also presented data from three main studies involving 1,664 patients with partial-onset seizures who were already treated with up to three other anti-epileptic medicines.
Maltese: Il-kumapnija ppreżentat ukoll dejta minn tliet studji ewlenin li involvew 1,664 pazjent b'aċċessjonijiet parzjali li kienu diġà ġew ikkurati bi tliet mediċini oħra antiepilettiċi.
English: On 15 January 2010, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Comfyde, for use in the treatment of partial-onset seizures in patients with epilepsy.
Maltese: Fil-15 ta' Jannar 2010, Janssen-Cilag International NV għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Comfyde, li jintuża għall-kura ta' aċċessjonijiet parzjali f'pazjenti li jbatu mill-epilessija.
English: Comfyde was expected to be used to treat patients aged 16 years and above.
Maltese: Comfyde kien mistenni li jintuża f'pazjenti minn 16-il sena 'l fuq.
English: What is Comfyde?
Maltese: Kif kien mistenni li jaħdem Comfyde?
English: Withdrawal of the marketing authorisation application for Comfyde (carisbamate)
Maltese: Irtirar tal-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq għal Comfyde (carisbamate)
English: By reducing the activity of sodium channels and through its other possible actions, carisbamate was expected to prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit happening.
Maltese: Bit-tnaqqis tal-attività fil-kanali tas-sodju u permezz tal-azzjonijiet possibbli l-oħra, carisbamate kien mistenni li ma jippermettix l-attvità elettrika anormali tinfirex malmoħħ, għaldaqstant inaqqas il-possibiltà li sseħħ aċċessjoni.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Maltese: Din hija tip ta' epilessija fejn ħafna attività elettrika f'naħa waħda tal-moħħ tikkawża sintomi bħalma huma movimenti għallgħarrieda, mimlija skossi ta' naħa minnhom tal-ġisem, smiegħ mhux ċar, sens ta' xamm, jew viżjoni, tgħarix jew sens ta' biża' f'daqqa.
English: How is Comfyde expected to work?
Maltese: Għal xiex kien mistenni li jintuża Comfyde?
English: The exact way in which carisbamate works in the body is not known, but some of its activity might be explained by the blocking of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Maltese: Is-sustanza attiva f'Comfyde, carisbamate, hija mediċina antiepilettika. ll-mod eżatt li bih carisbamate jaħdem fil-ġisem mhux magħruf, iżda ftit mill-attività tiegħu tista' tiġi spjegata billi jiġi mblukkati lkanali tas-sodju (pori fuq il-wiċċ taċ-ċelloli tan-nervituri) li jippermettu t-trażmissjoni tal-impulsi elettriċi bejn iċ-ċelloli tan-nervituri.
English: Comfyde was expected to be used as an add-on to existing treatments for partial-onset seizures (fits) with or without secondary generalisation in patients with epilepsy.
Maltese: Comfyde kien mistenni li jintuża bħala żieda mal-kura eżistenti għall-kura ta' aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja f'pazjenti li jbatu mill-epilessija.
English: The company has informed the CHMP that patients in epilepsy clinical trials will have their Comfyde treatment discontinued gradually.
Maltese: Għall-ewwel, l-effetti ta' Comfyde ġew ittestjati f'mudelli sperimentali qabel ġew studjati fuq ilbniedem.
English: This means that the CHMP was still evaluating the initial documentation provided by the company.
Maltese: Dan ifisser li s-CHMP kien għadu qiegħed jevalwa ddokumentazzjoni inizjali pprovduta mill-kumpanija.
English: The patients added either Comfyde or placebo (a dummy treatment) to their existing treatment.
Maltese: Il-pazjenti żiedu jew Comfyde jew plaċebo (trattament finta) mal-kura li kienu qegħdin jirħdu.
English: ATCvet code: QI04AA02.
Maltese: QI04AA02.
English: - Reproductive system disorders: abortion, perinatal mortality or premature parturition - Systemic disorders: apathy, recumbency, fever, anorexia or lethargy.
Maltese: - Disturbi tas-sistema riproduttiva: abort, mortalità perinatali jew ħlas prematur - Disturbi sistemiċi: apatija, rikombenza, deni, anoressija jew letarġija.
English: Av. Párroco Pablo Díez, 49-57 ES-24010 León
Maltese: Párroco Pablo Díez, 49-57 ES-24010