FrancophonIA/ELRC3.0 huggingface dataset:
English: • in combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
Maltese: • f'taħlita ma' prodotti mediċinali oħra għall-kura tad-dijabete, inkluż mal-insulina, f'pazjenti li ma jkunux ikkontrollati kif jixraq b'metformin u b'dawn il-prodotti mediċinali (ara sezzjonijiet 4.4, 4.5 u 5.1 għal dejta disponibbli dwar taħlitiet differenti)
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride.
Maltese: Komboglyze 2.5 mg/1,000 mg pilloli miksijin b'rita Kull pillola fiha 2.5 mg ta' saxagliptin (bħala l-hydrochloride) u 1,000 mg ta' metformin hydrochloride.
English: Avoid excessive alcohol intake while taking Komboglyze since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Komboglyze peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: • Komboglyze 2.5 mg/850 mg film-coated tablets (‘tablets') are light brown to brown and round, with “2.5/850” printed on one side and “4246” printed on the other side, in blue ink.
Maltese: • Il-pilloli miksijin b'rita Komboglyze 2.5 mg/850 mg huma pilloli miksijin b'rita (‘pilloli') tondi kannella ċari jagħtu fil-kannella, b' “2.5/850” ittimbrati fuq naħa waħda u “4246” ittimbrati fuq in-naħa l-oħra, b'linka ċelesti.
English: Iodinated contrast agents
Maltese: Metformin huwa kontraindikat
English: Immune system disorders Hypersensitivity reactions
Maltese: Disturbi fis-sistema immuni
English: Event rate per 100 patient-years
Maltese: Rata ta' avveniment għal kull 100 pazjentsena
English: Saxagliptin twice daily add-on to metformin therapy An add-on to metformin placebo-controlled study of 12-week duration was conducted to evaluate the efficacy and safety of saxagliptin 2.5 mg twice daily in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Maltese: Saxagliptin darbtejn kuljum miżjud ma' terapija ta' metformin Studju miżjud ma' metformin kontrollat bi plaċebo ta' 12-il ġimgħa sar biex jevalwa leffikaċja u s-sigurtà ta' saxagliptin 2.5 mg darbtejn kuljum flimkien ma' metformin f'pazjenti li ma kellhomx kontroll gliċemiku xieraq (HbA1c 7-10%) b'metformin waħdu.
English: Clinical trial data and postmarketing data
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: The red blood cells most likely represent a secondary compartment of distribution.
Maltese: Iċ-ċelluli lħomor tad-demm x'aktarx jirrappreżentaw kompartiment sekondarju ta' distribuzzjoni.
English: • inflamed stomach (gastritis) or gut, sometimes caused by an infection (gastro-enteritis)
Maltese: • stonku iffjammat (gastrite) jew imsaren, kultant ikkawżata b'infezzjoni (gastro-enterite)
English: Infections and infestations Upper respiratory infection Common Urinary tract infection
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni respiratorja fil-parti ta' fuq
English: When used as add-on to metformin plus a sulphonylurea, the overall incidence of reported hypoglycaemia was 10.1% for saxagliptin 5 mg and 6.3% for placebo.
Maltese: 1 % għal saxagliptin 5 mg u 6.3% għal plaċebo.
English: The exposure of the active metabolite and the plasma DPP4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Maltese: L-esponiment tal-metabolu attiv u l-inibizzjoni tal-attività ta' DPP4 fil-plażma fl-intervall ta' bejn id-dożi ma kienx effettwat minn rifampicin (ara sezzjoni 4.4).
English: Primary composite endpoint: MACE Secondary composite endpoint: MACE plus All-cause mortality
Maltese: MACE plus Mortalità ta' kull kawża
English: There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Maltese: Kien hemm 4,148 pazjent/a b'dijabete tat-tip 2 inklużi 3,021 pazjent/a ikkurati b'saxagliptin, randomizzat f'sitt studji kliniċi double-blind, kontrollati dwar is-sigurtà u l-effikaċja biex jiġu evalwati l-effetti ta' saxagliptin fuq il-kontroll tal-glucose fid-demm.
English: A1c was lower with saxagliptin compared to placebo in an exploratory analysis.
Maltese: A1C kien iktar baxx b'saxagliptin meta mqabbel ma' plaċebo f'analiżi esploratorja.
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Maltese: Sejbiet minimi ta' iperplażija tal-limfojd li ma tavvanzax relatata mas-sistema immunitarja fil-milza, nodi tal-limfa u mudullun tal-għadam mingħajr konsegwenzi avversi kienu rrappurtati fl-ispeċi kollha eżaminati u b'esponimenti minn 7 darbiet l-RHD.
English: Monitoring of renal function is necessary to prevent metformin-associated lactic acidosis, particularly in the elderly (see sections 4.3, 4.4 and 5.2).
Maltese: Monitoraġġ tal-funzjoni renali hija essenzjali biex tiġi evitata aċidożi lattika assoċjata ma' metformin b'mod partikolari fl-anzjani (ara sezzjonijiet 4.3, 4.4 u
English: Komboglyze 2.5 mg/850 mg film-coated tablets saxagliptin/metformin hydrochloride
Maltese: Komboglyze 2.5 mg/850 mg pilloli miksijin b'rita saxagliptin/metformin hydrochloride
English: CARTON Komboglyze 2.5 mg/850 mg film-coated tablets
Maltese: KARTUNA Komboglyze 2.5 mg/850 mg pilloli miksijin b'rita
English: - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); - Diabetic pre-coma; - Severe renal failure (GFR < 30 mL/min) (see sections 4.2, 4.4 and 5.2); - Acute conditions with the potential to alter renal function such as: - dehydration, - severe infection, - shock; - Acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure, - recent myocardial infarction, - shock; - Hepatic impairment (see sections 4.2 and 4.5); - Acute alcohol intoxication, alcoholism (see section 4.5); - Breast-feeding (see section 4.6).
Maltese: Insuffiċjenza renali severa (GFR < 30 mL/min) (ara sezzjonijiet 4.2, 4.4 u 5.2); Kondizzjonijiet akuti li jistgħu jalteraw il-funzjoni renali bħal: - de-idratazzjoni, - infezzjoni severa, - xokk;
English: The reductions from baseline in HbA1c respectively for saxagliptin and sitagliptin in the primary per-protocol analysis were -0.5% (mean and median) and -0.6% (mean and median).
Maltese: Ittnaqqis mil-linja bażi fl-HbA1c rispettivament kemm għal saxagliptin kif ukoll għal sitagliptin fl-analiżi ta' qabel il-protokol ewlieni kienu -0.5% (medju u medjan) u -0.6% (medju u medjan).
English: Symptoms of lactic acidosis include: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat
Maltese: Sintomi ta' aċidożi lattika jinkludu: rimettar uġigħ fl-istonku (uġigħ addominali) bugħawwieġ fil-muskoli sensazzjoni ġenerali li ma tiflaħx flimkien ma' għeja severa diffikultà biex tieħu n-nifs temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Maltese: Fil-bnedmin, irrispettivament mill-attività tiegħu fuq il-gliċemija, metformin għandu effetti favorevoli fuq il-metaboliżmu tal-lipidi.
English: Slovenská republika AstraZeneca AB, o.z.
Maltese: Is-sustanzi l-oħra huma:
English: In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite, were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine.
Maltese: Fi studji li saru f'individwi b'saħħithom, la l-farmakokinetika ta' saxagliptin u lanqas tal-metabolu ewlieni tiegħu, ma kienu mibdula b'mod sostanzjali b'metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, sustanzi kontra l-aċidu jew famotidine.
English: A lower proportion of patients in the saxagliptin group (1.1%) compared to the glimepiride group (15.3%), experienced a confirmed or severe hypoglycaemic event.
Maltese: Proporzjon iżgħar ta' pazjenti fil-grupp ta' saxagliptin (1.1%) meta mqabbel mal-grupp ta' glimepiride (15.
English: The saxagliptin and dapagliflozin group achieved significantly greater reductions in HbA1c versus either the saxagliptin group or dapagliflozin group at 24 weeks (see Table 6).
Maltese: Il-grupp ta' saxagliptin u dapagliflozin kiseb tnaqqis ferm akbar f'HbA1c meta mqabbel malgrupp ta' saxagliptin jew il-grupp ta' dapagliflozin f'24 ġimgħa (ara Tabella 6).
English: However, among surviving mothers with evaluable litters, maternal toxicity was limited to marginal reductions in body weight over the course of gestation days 21 to 29; and associated developmental toxicity in these litters was limited to foetal body weight decrements of 7%, and a low incidence of delayed ossification of the foetal hyoid.
Maltese: Madankollu, fost l-ommijiet li baqgħu ħajjin b'wild li seta'jiġi evalwat, tossiċità fl-omm kienet limitata għal tnaqqis żgħir fil-piż tal-ġisem fuq il-kors tat-tqala minn jum 21 sa jum 29; u it-tossiċità tal-iżvilupp f'dawn il-wild kienet limitata għall-tnaqqis fil-piż ta' 7% u frekwenza baxxa ta' ritardar flossifikazzjoni tal-ħyoid tal-fetu.
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Maltese: Dejta ta' qabel l-użu kliniku għal metformin magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva, ma turi l-ebda periklu speċjali għall-bnedmin.
English: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 2.5 mg saxagliptin (bħala hyrdrochloride) u 1,000 mg ta' metformin hydrochloride.
English: The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Maltese: Iż-żieda tal-insulina miċ-ċelluli-beta tal-frixa u t-tnaqqis ta' glukagon miċ-ċelluli alfa tal-frixa kienu assoċjati ma' konċentrazzjonijiet aktar baxxi tal-glucose waqt sawm u tnaqqis fl-eskursjoni tal-glucose wara tagħbija ta' glucose orali jew ikla.
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Maltese: Sustanzi ketajoniċi li jitneħħew permezz ta' sekrezzjoni mit-tubi renali (eż cimetidine) jistgħu jinteraġixxu ma' metformin billi jikkompetu mas-sistemi renali tat-transport tubulari komuni.
English: Anaphylactic reactions including anaphylactic shock (see sections 4.3 and 4.4)
Maltese: Indeboliment epatiku (ara sezzjonijiet 4.2 u 4.5);
English: The safety profile of saxagliptin added to dapagliflozin plus metformin in the long-term treatment period was consistent with that observed in the 24-week treatment period in this study and in the trial in which saxagliptin and dapagliflozin were given concomitantly as add-on therapy to patients treated with metformin (described below).
Maltese: Il-profil ta' sigurtà ta' saxagliptin miżjud ma' dapagliflozin flimkien ma' metformin fil-perjodu ta' kura fit-tul kien konsistenti ma' dak osservat fil-perjodu ta' kura ta' 24 ġimgħa f'dan l-istudju u fil-prova li fiha saxagliptin u dapagliflozin ngħataw flimkien bħala terapija miżjuda lil pazjenti kkurati b'metformin (deskritt hawn taħt).
English: The following statements reflect the information available on the individual active substances.
Maltese: Iddikjarazzjonijiet li ġejjin jirriflettu l-informazzjoni li hemm fuq is-sustanzi attivi individwali.
English: Maximum total daily dose is 5 mg.
Maltese: Id-doża totali massima ta' kuljum hija 5 mg.
English: The reduction in FPG was slightly less in the saxagliptin group and there were more discontinuations (3.5% vs. 1.2%) due to lack of efficacy based on FPG criteria during the first 24 weeks of the study.
Maltese: It-tnaqqis fl-FPG kien ftit anqas fil-grupp ta' saxagliptin u kien hemm aktar twaqqif (3.5% vs 1.2%) minħabba nuqqas ta' effikaċja ibbażat fuq kriterji FPG waqt l-ewwel ġimgħat tal-istudju.
English: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1000 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 2.5 mg saxagliptin (bħala hyrdrochloride) u 1000 mg ta' metformin hydrochloride.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Maltese: Metformin huwa biguanide b'effetti anti-ipergliċemiċi, billi jnaqqas kemm il-glucose bażali kif ukoll dak wara l-ikliet.
English: Patients were randomised to one of three double-blind treatment groups to receive saxagliptin 5 mg and dapagliflozin 10 mg added to metformin, saxagliptin 5 mg and placebo added to metformin, or dapagliflozin 10 mg and placebo added to metformin.
Maltese: Il-pazjenti ġew randomizzati għal wieħed minn tliet gruppi ta' kura double-blind biex jirċievu saxagliptin 5 mg u dapagliflozin 10 mg miżjuda ma' metformin, saxagliptin 5 mg u plaċebo miżjud ma' metformin, jew dapagliflozin 10 mg u plaċebo miżjud ma' metformin.
English: The incidence of adjudicated pancreatitis events was 0.3% in both saxagliptin-treated patients and placebo-treated patients in the intent-to-treat population.
Maltese: L-inċidenza ta' episodji ta' pankreatite aġġudikata kienet ta' 0.3% kemm f'pazjenti kkurati b'saxagliptin kif ukoll f'pazjenti kkurati bi plaċebo fil-popolazzjoni b'intenzjoni li tiġi kkurata.
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance of Komboglyze (see section 4.4).
Maltese: L-intossikazzjoni bl-alkoħol hija assoċjata ma' riskju akbar ta' aċidożi lattika, l-aktar f'każ ta' sawm, malnutriment jew indeboliment epatiku minħabba s-sustanza attiva metformin li hemm f'Komboglyze (ara sezzjoni 4.4).
English: Frequency estimates are based on the pooled analysis of the saxagliptin monotherapy, add-on to metformin and initial combination with metformin, add-on to sulphonylurea and add-on to thiazolidinedione clinical trials.
Maltese: L-istimi tal-frekwenza huma bbażati fuq l-analiżi kollettiva tal-monoterapija b'saxagliptin, miżjud ma' metformin u taħlita mill-bidu ma' metformin, miżjud ma' sulphonylurea u miżjud ma' thiazolidinedione fil-provi kliniċi.
English: Improvements in HbA1c, PPG, and FPG following treatment with saxagliptin 5 mg plus metformin were sustained up to Week 102.
Maltese: Titjib fl-HbA1c, PPG u FPG wara kura b'saxagliptin 5 mg ma' metformin żammew sa' Ġimgħa 102.
English: In the confirmatory full analysis set, mean reductions were -0.4% and -0.6% respectively for saxagliptin and sitagliptin, with median reductions of -0.5% for both groups.
Maltese: Fis-sett tal-analiżi komplut li sar biex jikkonferma, il-medja tat-tnaqqis kienu -0.4% u -0.6% rispettivament għal saxagliptin u sitagliptin, bi tnaqqis medjan ta' -0.5% għaż-żewġ gruppi.
English: Film-coated tablet (tablet).
Maltese: Pillola miksija b'rita (pillola)
English: Across clinical studies, the incidence of laboratory AEs was similar in patients treated with saxagliptin 5 mg compared to patients treated with placebo.
Maltese: Waqt studji kliniċi, il-frekwenza ta' AEs tal-laboratorju kienet simili f'pazjenti ikkurti b'saxagliptin 5 mg meta mqabbla ma' pazjenti ikkurati bil-plaċebo.
English: * Intent-to-treat population
Maltese: TAL-PRODOTT MEDIĊINALI
English: CARTON Komboglyze 2.5 mg/1,000 mg film-coated tablets
Maltese: KARTUNA Komboglyze 2.5 mg/1,000 mg pilloli miksijin b'rita
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets saxagliptin/metformin hydrochloride
Maltese: Komboglyze 2.5 mg/1,000 mg pilloli miksijin b'rita saxagliptin/metformin hydrochloride
English: Komboglyze 2.5 mg/1000 mg film-coated tablets saxagliptin/metformin hydrochloride
Maltese: Komboglyze 2.5 mg/1000 mg pilloli miksijin b'rita saxagliptin/metformin hydrochloride
English: • Lactic acidosis, Komboglyze may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Maltese: • Aċidożi lattika, Komboglyze jista' jikkawża effett sekondarju rari ħafna (jista' jaffettwa sa utent 1 minn kull 10,000) iżda serju ħafna msejjaħ aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: How to take Komboglyze
Maltese: X'fih Komboglyze
English: In rabbits, the effects of saxagliptin were limited to minor skeletal variations observed only at maternally toxic doses (NOEL 158 and 224 times the human exposure for saxagliptin and the major metabolite, respectively at RHD).
Maltese: Fil-fniek, l-effetti ta' saxagliptin kienu limitati għal bidliet minuri flgħadam li dehru biss b'dożi li kienu tossiċi għall-omm (NOEL 158 u 224-il darba lesponiment għal saxagliptin u l-metabolu ewlieni tiegħu fil-bniedem, rispettivament b'RHD).
English: • being sick or indigestion (dyspepsia)
Maltese: • rimettar jew indiġestjoni (dispepsja)
English: As add-on to metformin and a sulphonylurea: dizziness (common), fatigue (common) and flatulence (common).
Maltese: Bħala taħlita li tiġi miżjuda ma' metformin flimkien ma' sulphonylurea: sturdament (komuni), għeja (komuni) u gass (komuni).
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Maltese: • Uġigħ sever u persistenti fiż-żaqq (żona tal-istonku) li jista' jasal sa dahrek, kif ukoll dardir u rimettar, għaliex dan jista' jkun sinjal ta' frixa infammata (pankreatite).
English: Use with medicinal products known to cause hypoglycaemia Insulin and sulphonylureas are known to cause hypoglycaemia.
Maltese: Użu ma' prodotti mediċinali magħrufin li jikkawżaw ipogliċemija L-insulina u sulphonylureas huma magħrufin li jikkawżaw ipogliċemija.
English: Table 5 Key efficacy results in placebo-controlled, combination therapy studies of saxagliptin and metformin
Maltese: Riżultati ewlenin għal effikaċja fl-istudji ikkontrollati bil-plaċebo, b'terapija kombinata ta' saxagliptin u metformin
English: Diabetic skin lesions are a common complication of diabetes.
Maltese: Feriti tal-ġilda minħabba d-dijabete huma komplikazzjoni komuni tad-dijabete.
English: Gastroenteritis
Maltese: FARMAĊEWTIKU
English: Strength
Maltese: Prodott m
English: Zonegran zonisamide
Maltese: Zonegran zonisammid
English: It is available as capsules (25, 50 and 100 mg) and orodispersible tablets (25, 50, 100 and 300 mg).
Maltese: Jiġi f'kapsuli (25, 50 u 100 mg) u bħala pilloli orodispersibbli (25, 50, 100 u 300 mg).
English: The full EPAR for Zonegran 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 Zonegran:
Maltese: Aktar informazzjoni dwar Zonegran:
English: The most common side effects with Zonegran (seen in more than 1 patient in 10) are loss of appetite, agitation, irritability, confusion, depression, ataxia (an inability to co-ordinate muscle movements), dizziness, memory impairment, somnolence (sleepiness), diplopia (double vision) and decreased blood bicarbonate levels; although the safety profile is similar in children and adults, some side effects are reported more frequently in children than in adults.
Maltese: L-effetti sekondarji l-iktar komuni f'Zonegran (li dehru f'iktar minn pazjent wieħed minn kull 10) huma n-nuqqas ta' aptit, aġitazzjoni, irritabilità, konfużjoni, dipressjoni, diffikultà fil-koordinazzjoni ta' movimenti muskolari, sturdament, tfixkil fil-memorja, ngħas kbir, diplopja (viżjoni doppja) u tnaqqis fil-livelli ta' bikarbonat fid-demm; għalkemm il-profil ta' sigurtà huwa simili fit-tfal u l-adulti, xi effetti sekondarji huma rrappurtati aktar frekwenti fit-tfal milli fl-adulti.
English: Zonegran is a medicine that contains the active substance zonisamide.
Maltese: Zonegran huwa mediċina li fiha s-sustanza attiva zonisammid.
English: This document is a summary of the European public assessment report (EPAR) for Zonegran.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zonegran.
English: Adults taking 500 mg Zonegran per day had an average reduction in seizure frequency of 51%, compared with 16% in those taking placebo.
Maltese: Adulti li kienu qed jieħdu 500 mg Zonegran kuljum kellhom tnaqqis medju ta' 51 % fil-frekwenza tal-attakki, meta mqabbla ma' 16 % ta' dawk li kienu qed jingħataw il-plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zonegran on 10 March 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zonegran fl-10 ta' Marzu 2005.
English: The percentage of patients on carbamazepine who were seizure-free for six months was 74.7%.
Maltese: Il-perċentwal ta' pazjenti fuq Carbamazepine li ma kellhomx epilessija għal sitt xhur kien ta' 74.7%.
English: The active substance in Zonegran, zonisamide, is an anti-epileptic.
Maltese: Is-sustanza attiva f'Zonegran, iz-zonisammid, hija antiepilettika.
English: Zonegran used on its own was shown to be beneficial in adults with partial seizures: 69.4% of patients on Zonegran were seizure-free for six months.
Maltese: Zonegran użat waħdu intwera li kien ta' benefiċċju f'adulti b'epilessiji parzjali: 69.4% tal-pazjenti fuq Zonegran ma sofrewx epilessija għal sitt xhur.
English: These channels transmit electrical impulses between nerve cells.
Maltese: Dawn il-kanali jittrażmettu impulsi elettriċi bejn iċ-ċelloli tan-nervituri.
English: Why has Zonegran been approved?
Maltese: Għaliex ġie approvat Zonegran?
English: Severe rashes have occurred in patients taking Zonegran, including cases of Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction affecting the skin and mucous membranes).
Maltese: F'xi pazjenti li kienu qed jieħdu Zonegran, kien hemm raxx gravi, inkluż is-sindromu Stevens-Johnson (tip ta' reazzjoni allerġika perikoluża ħafna li taffetwa l-ġilda u l-membrani mukużi).
English: Zonegran used on its own was compared with carbamazepine, another anti-epileptic medicine, in a main study involving 583 adults newly diagnosed with partial epilepsy.
Maltese: Zonegran użat waħdu tqabbel ma' Carbamazepine, mediċina kontra l-epilessija oħra, fi studju prinċipali li involva 583 adult li jbatu minn epilessija parzjali, li kienu għadhom kif ingħataw dijanjożi.
English: In children, the number of seizures was at least halved in 50% of the patients taking Zonegran, compared with 31% of those taking placebo.
Maltese: Fit-tfal, in-numru ta' attakki ta' epilessija għall-inqas naqas bin-nofs f'50 % tal-pazjenti li jieħdu Zonegran meta mqabbla ma' 31 % ta' dawk li jieħdu plaċebo.
English: Two other main studies, one involving 351 adults and one involving 207 children (between 6 and 17 years old), looked at Zonegran as an add-on to existing treatment.
Maltese: Żewġ studji ewlenin oħra, wieħed li involva 351 adult u l-ieħor li involva 207 tifel u tifla (bejn sitt snin u 17-il sena), ħarsu lejn Zonegran bħala trattament ta' żieda għal kura eżistenti.
English: The total dose must not exceed 500 mg a day.
Maltese: Id-doża totali ma għandhiex taqbeż il-500 mg kuljum.
English: For further information, see the package leaflet.
Maltese: Qabel titwaqqaf, id-doża ta' Zonegran għandha titnaqqas ftit ftit.