FrancophonIA/ELRC3.0 huggingface dataset:
English: In renewal assessment reports as assessed by the Belgian NCA, two studies were identified, respectively supporting the withdrawal periods for Genta-kel 5% (MAH: Kela), and for Gentaveto-5 in calves (MAH: VMD).
Maltese: F'rapporti ta' valutazzjoni ta' tiġdid kif ivvalutati mill-NCA Belġjana, ġew identifikati żewġ studji, li jappoġġaw rispettivament il-perjodi ta' tiżmim għal Genta-kel 5 % (MAH:
English: Cattle, calves, pigs, piglets
Maltese: Frat, ħnieżer, żwiemel, klieb, qtates
English: Cattle, calves, pigs, piglets, weaners, horses, foals, dogs, cats
Maltese: Frat, għoġġiela, ħnieżer, qżieqeż li qegħdin jinfatmu (weaners), żwiemel, mħaħar, klieb, qtates
English: G. For products listed in Annex I for which the recommended total dose is between 24 mg gentamicin base per kg bw and 50 mg gentamicin base per kg bw for cattle
Maltese: Għall-prodotti elenkati fl-Anness I li d-doża totali rakkomandata tagħhom hi bejn 24 mg gentamicin bażi għal kull kg bw u 50 mg gentamicin bażi għal kull kg bw għall-frat
English: Cattle:
Maltese: Frat:
English: C. For Gentavall 5 mg/ml listed in Annex I (Marketing Authorisation Holder: Mevet S.A.U.)
Maltese: Għal Gentavall 5 mg/ml elenkat fl-Anness I (Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq:
English: The withdrawal period of 192 days cannot be applied to products for which the total recommended dose exceeds the dose used in the residues study, i.e., 24 mg gentamicin base per kg bw.
Maltese: Il-perjodu tal-irtirar ta' 192 jum ma jistax jiġi applikat għal prodotti li d-doża rakkomandata totali għalihom taqbeż id-doża użata fl-istudju tarresidwi, jiġifieri, 24 mg gentamicin bażi għal kull kg bw.
English: F. For all other products listed in Annex I for which the recommended total doses do not exceed 24 mg gentamicin base per kg bw for cattle and 50 mg gentamicin base per kg bw for pigs
Maltese: Għall-prodotti l-oħra kollha elenkati fl-Anness I li d-dożi totali rakkomandati tagħhom ma jaqbżux 24 mg gentamicin bażi għal kull kg bw għall-frat u 50 mg gentamicin bażi għal kull kg bw għall-ħnieżer
English: GENTAMICINA FP 10% gentamicin 100 mg/ml
Maltese: FP 10% gentamicin 100 mg/ml
English: IM, slow IV
Maltese: IM, IV bil-mod
English: A. For Aagent 50 mg/ml listed in Annex I (Marketing Authorisation Holder: Fatro S.p.A.)
Maltese: Għal Aagent 50 mg/ml elenkat fl-Anness
English: The residue measured (gentamicin) did not correspond to the established marker residue, and the available data are not sufficient to allow verification of the validity of the HPLC-MS/MS analytical method.
Maltese: Ir-residwu kkalkulat (gentamicin) ma kkorrispondiex mar-residwu indikat stabbilit, u d-data disponibbli mhijiex biżżejjed biex tagħti lok għall-verifika tal-validitià tal-metodu analitiku HPLC-MS/MS.
English: IM, SC, slow IV
Maltese: IM, SC, IV bilmod
English: The dose administered was 4 mg/kg bw with a 12 hours interval on the first day, and afterwards at 24 hours intervals, until day 5 inclusive.
Maltese: Id-doża mogħtija kienet ta' 4 mg/kg bw b'intervall ta' 12-il siegħa fl-ewwel jum, u wara, f'intervalli ta' 24 siegħa, sal-5 jum inklużiv.
English: GENTAVALL 5mg/ml SOLUCIÓN INYECTABLE - 304 ESP
Maltese: INYECTABLE - 304 ESP
English: Intramuscular or intravenous use: Meat and offal: 139 days.
Maltese: Laħam u ġewwieni tal-annimal: 139 jum.
English: It is available as tablets (75, 150 and 300 mg).
Maltese: Jiġi f'għamla ta' pilloli (75, 150 u 300 mg).
English: The full EPAR for Irbesartan Zentiva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Irbesartan Zentiva jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Previously known as Irbesartan Winthrop.
Maltese: Dak li qabel kien magħruf bħala Irbesartan Winthrop.
English: Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Maltese: L-użu tiegħu ġie eżaminat fil-kombinazzjoni mal-idroklorotijażide f'1,736 pazjent.
English: EPAR summary for the public irbesartan
Maltese: Sommarju tal-EPAR għall-pubbliku irbesartan
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Winthrop on 19 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Irbesartan Winthrop fid-19 ta' Jannar 2007.
English: Irbesartan Zentiva was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Maltese: Irbesartan Zentiva tqabbel mal-plaċebo (trattament finta) f'712-il pazjent u ma' mediċini antipertensivi oħra (atenolol, enalapril jew amlodipina) fi 823 pazjent.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Zentiva.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Irbesartan Zentiva.
English: Irbesartan Zentiva is a medicine that contains the active substance irbesartan.
Maltese: Irbesartan Zentiva huwa mediċina li fiha s-sustanza attiva irbesartan.
English: The name of the medicine was changed to Irbesartan Zentiva on 6 February 2012.
Maltese: L-isem tal-mediċina nbidel u sar Irbesartan Zentiva fis-6 ta' Frar 2012.
English: The usual recommended dose of Irbesartan Zentiva is 150 mg once a day.
Maltese: Id-doża normalment rakkomandata ta' Irbesartan Zentiva hija ta' 150 mg darba kuljum.
English: There was a 23% relative risk reduction compared with amlodipine.
Maltese: Meta mqabbel mal-amlodipina, kien hemm 23% tnaqqis fir-riskju relattiv.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Maltese: Meta użat mal-idroklorotijażide, l-effetti taż-żewġ mediċini kienu addittivi.
English: Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Maltese: It-trattament jinbeda b'doża ta' 150 mg darba kuljum u normalment tiżdied għal 300 mg darba kuljum.
English: A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Maltese: Doża inizjali ta' 75 mg tista' tintuża fil-pazjenti li għaddejjin minn emodijaliżi (teknika ta' tisfija tad-demm) jew f'pazjenti li għandhom iktar minn 75 sena.
English: In the second kidney disease study, Irbesartan Zentiva reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Maltese: Fit-tieni studju dwar ilmard tal-kliewi, Irbesartan Zentiva naqqas b'20% meta r-riskju relattiv ta' rduppjar tal-livelli ta' kreatinina fid-demm, tal-bżonn ta' trapjant ta' kilwa jew ta' dijaliżi, jew taż-żmien qabel il-mewt talpazjent matul l-istudju ġew imqabbla mal-plaċebo.
English: For the treatment of kidney disease, Irbesartan Zentiva was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Maltese: Għat-trattament tal-mard tal-kliewi, Irbesartan Zentiva ġie eżaminat f'żewġ studji fuq skala kbira li involvew total ta' 2,326 pazjent bid-dijabete tat-tip 2, Irbesartan Zentiva ittieħed għal sentejn jew aktar.
English: The active substance in Irbesartan Zentiva, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Irbesartan Zentiva, irbesartan, hija tip ta' 'antagonist tar-riċetturi talanġjotensina II' li tfisser li jimblokka l-azzjoni tal-ormon fil-ġisem imsejjaħ anġjotensina II. Lanġjotensina
English: What is Irbesartan Zentiva?
Maltese: Għal xiex jintuża Irbesartan Zentiva?
English: Irbesartan Zentiva was originally studied in 11 trials for its effects on blood pressure.
Maltese: Irbesartan Zentiva kien oriġinarjament studjat fi 11-il prova li saru biex jivvalutaw l-effetti tiegħu fuq il-pressjoni tad-demm.
English: The most common side effect with Irbesartan Zentiva (seen in more than 1 patient in 10) is dizziness, hyperkalaemia (high blood potassium levels).
Maltese: L-iktar effett sekondarju komuni b'Irbesartan Zentiva (li deher f'iktar minn pazjent 1 minn kull 10) huwa l-ipogliċemija (livelli għolja ta' potassju fid-demm).
English: Why has Irbesartan Zentiva been approved?
Maltese: Għaliex ġie approvat Irbesartan Zentiva?
English: Irbesartan Zentiva in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Irbesartan Zentiva ma għandux jintuża flimkien ma' mediċini li fihom l-aliskiren (użat fil-kura tal-ipertensjoni essenzjali) f'pazjenti bid-dijabete, jew insuffiċjenza moderata jew gravi fil-kliewi.
English: In the first kidney disease study, Irbesartan Zentiva was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Maltese: Fl-ewwel studju dwar il-mard tal-kliewi, Irbesartan Zentiva rriżulta aktar effikaċi mill-plaċebo biex inaqqas ir-riskju ta' żvilupp ta' ħsara tal-kliewi skont it-tneħħija tal-proteina.
English: In patients with hypertension and type 2 diabetes, Irbesartan Zentiva is added to some other treatments for hypertension.
Maltese: Fil-pazjenti b'ipertensjoni u b'dijabete tat-tip 2, Irbesartan Zentiva jiżdied ma' trattamenti oħra għallipertensjoni.
English: Other information about Irbesartan Zentiva
Maltese: Kif jintuża Irbesartan Zentiva?
English: Irbesartan Zentiva is used in adults who have essential hypertension (high blood pressure).
Maltese: Il-kejl ewlieni tal-effikaċja kien ittnaqqis tal-pressjoni tad-demm dijastolika (pressjoni tad-demm imkejla bejn żewġ taħbitiet tal-qalb).
English: In the blood pressure studies, Irbesartan Zentiva was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Maltese: Fl-istudji dwar il-pressjoni tad-demm, irriżulta li Irbesartan Zentiva kien aktar effikaċi mill-plaċebo biex inaqqas il-pressjoni tad-demm dijastolika u kellu effetti simili għall-mediċini antipertensivi oħra.
English: The CHMP decided that Irbesartan Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Irbesartan Zentiva huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The second study looked at whether Irbesartan Zentiva increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Maltese: L-għan tat-tieni studju kien dak li jeżamina jekk Irbesartan Zentiva għenx biex ittardja l-mument li fih il-pazjenti rduppjaw il-livelli ta' kreatinina fid-demm (marker talmarda tal-kliewi), biex ittardja l-bżonn ta' trapjant ta' kilwa jew dijaliżi jew tawwal iż-żmien qabel ilmewt tal-pazjent.
English: In this study, Irbesartan Zentiva was compared with placebo and with amlodipine.
Maltese: Din il-mediċina hija l-istess bħal Aprovel, li hija diġà awtorizzata fl-Unjoni Ewropea (UE).
English: For the full description of all side effects reported with Irbesartan Zentiva, see the package leaflet.
Maltese: Għad-deskrizzjoni sħiħa tal-effetti sekondarji kollha rrappurtati b'Irbesartan Zentiva, ara l-fuljett ta' tagħrif.
English: Irbesartan Zentiva is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Maltese: Irbesartan Zentiva jintuża wkoll għallkura ta' mard fil-kliewi f'adulti li jbatu minn ipertensjoni u dijabete tat-tip 2.
English: 4 days.
Maltese: 4 snin.
English: The active substance is levetiracetam.
Maltese: - Is-sustanza attiva hi levetiracetam.
English: Serum Creatinine (mg/dl)
Maltese: Kreatinina fis-serum (mg/dl)
English: 15 minutes
Maltese: 15-il minuta Darbtejn kuljum
English: CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m
Maltese: CLcr (ml/min/1.73 m 2) = --------------------------- x 1.73 BSA pazjent (m
English: • Sodium chloride 9 mg/ml (0.9%) solution for injection
Maltese: • Sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni
English: • infection;
Maltese: • infezzjoni;
English: Date of first authorisation: 08 January 2014 Date of latest renewal: 20 November 2018
Maltese: Data tal-aħħar tiġdid: 20 ta' Novembru 2018
English: The metabolite ucb L057 is pharmacologically inactive.
Maltese: Il-metabolit ucb L057 mhuwiex attiv farmakoloġikament.
English: • anorexia (loss of appetite);
Maltese: • anoressija (nuqqas ta' aptit);
English: Children (4 to 12 years)
Maltese: Tfal (4 sa 12-il sena)
English: Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95% CI:-7.8 8.2).
Maltese: Kien hemm 73.0 % tal-pazjenti li ġew trattati b'levetiracetam u 72.8 % ta' pazjenti li ġew trattati b'carbamazepine-CR li damu sitt xhur mingħajr aċċessjonijiet; id-differenza assoluta aġġustata bejn it-trattamenti kienet ta' 0.2 % (95 % CI:-7.8 8.2) .
English: Depression, hostility/aggression, anxiety, insomnia, nervousness/irritability
Maltese: Depressjoni, ostilità/aggressjoni, ansjetà, insomnija, nervożità/irritabilità
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Maltese: [140 -età (snin)] x piż (kg) CLcr (ml/min) = ---------------------------------------------------- (x 0.85 għan-nisa) 72 x livell ta' kreatinina fis-serum (mg/dl)
English: The elimination half-life was approximately 5 hours.
Maltese: Il-half-life ta' eliminazzjoni kien bejn wieħed u ieħor 5 sigħat.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Maltese: Sindromu ta' Stevens-Johnson, eritema multiforme
English: Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Maltese: Levetiracetam 1,000 mg me kellu ebda effett fuq il-farmakokinetika ta' kontraċettivi orali (ethinylestradiol u levonorgestrel); parametric endokrinarji ( luteinizing hormone u progesterone).
English: 10 vials 25 vials
Maltese: 10 kunjetti 25 kunjett
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskelettriċi u tat-tessut konnettiv
English: • liver failure, hepatitis;
Maltese: • falliment tal-fwied, epatite;
English: Diplopia, vision blurred
Maltese: Diplopja, vista mċajpra
English: • muscle weakness, myalgia (muscle pain);
Maltese: • dgħufija muskolari,mijalġja (uġigħ muskolari);
English: ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Maltese: ks= 0.55 fi tfal sa inqas minn 13-il sena u fl-adolexxenti feminili; ks= 0.7 f'adolexxenti maskili.
English: In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
Maltese: In vitro, kemm levetiracetam u kemm il-prodott ewlieni tal-metabolożmu ma fixklux l-iżoformi taċ-ċitokromju P450 fil-fwied ( CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 u 1A2), glucuronyl transferase (UGT1A1 u UGT1A6) u l-attivitajiet tal-epoxide hydroxylase. Levetiracetam m'għandu ebda effett ukoll fuq il-glukuronidazzjoni ta' valproic acid in vitro.
English: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Water for injections
Maltese: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Ilma għal injezzjonijiet
English: Alopecia, eczema, pruritus
Maltese: Alopeċja, ekżema, ħakk
English: 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile.
Maltese: Fit-tfal u addoloxxenti t'eta` ta' 4-16-il sena, ir-rimettar (komuni ħafna, 11.2%), aġitazzjoni (komuni, 3.4%), tibdil fil-burdati (komuni, 2.1%), tibdil spiss ta' emozzjonijiet (komuni, 1.7%), aggressjoni (komuni, 8.2%), mġieba abnormali (komuni, 5.6%), u telqa (komuni, 3.9%) kienu rappurtati iżjed frekwentament minn gruppi ta' etajjiet oħra jew mill-profil ta' sigurta` totali.
English: • depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
Maltese: • depressjoni, ostilità jew aggressjoni, ansjetà, insomnja , nervożiżmu jew irritabilità;
English: The intravenous administration of doses up to 4,000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2,500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated.
Maltese: L-għoti ġol-vina ta' doża sa 4,000 mg dilwita f'100 ml ta' 0.9% sodium chloride mogħti fuq perijodu ta' aktar minn 15-il minuta u dożi għoljin sa 2,500 mg dilwiti b'100 ml ta' 0,9 sodium chloride infużi fuq aktar minn 5 minuti kienu evalwati.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Għal kondizzjonijiet ta' ħażna tal-prodott mediċinali dilwit, ara sezzjoni 6.3.
English: General dose: between 1,000 mg and 3,000 mg each day.
Maltese: Doża normali: bejn 1,000 mg u 3,000 mg kuljum.
English: Peak plasma concentration (Cmax) observed in 17 subjects following a single intravenous dose of 1,500 mg infused over 15 minutes was 51 ± 19 micrograms/ml (arithmetic average ± standard deviation).
Maltese: Il-konċentrazzjoni massima fil-plażma (Cmax) osservata fi 17-il individwu wara doża waħda ġol-vina ta' 1,500 mg infuża fuq perijodu ta' 15-il minuta kienet ta' 51 ± 19 mikrogrammi/ml (medja aritmetika ± devjazzjoni standard).
English: 72.2% of the levetiracetam treated patients and 45.2% of the patients on placebo had a 50% or greater decrease in the frequency of PGTC seizures per week.
Maltese: 72.2 % ta' pazjenti fuq levetiracetam u 45.2 % tal-pazjenti fuq plaċebo kellhom tnaqqis ta' 50 % jew aktar fil-frekwenza ta' aċċessjonijiet PGTC fil-ġimgħa.
English: • convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
Maltese: • konvulżjoni, disturb fil-bilanċ (disturb fl-ekwilibriju) sturdament (sensazzjoni ta' instabilità),
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Maltese: Amnesija, indeboliment fil-memorja, koordinazzjoni abnormali/atassja, paraestesija, disturb flattenzjoni
English: In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7%, 31.6% and 41.3% for patients on 1,000, 2,000 or 3,000 mg levetiracetam respectively and of 12.6% for patients on placebo.
Maltese: F'analisi miġbur, il-perċentaġġ ta' pazjenti li laħqu tnaqqis ta' 50 % jew iżjed mill-linja bażi fil-frekwenza fil-ġimgħa ta' aċċessjonijiet tat-tip parzjali b'doża stabli (12/14 ġimgħa), kien ta' 27.7 %, 31.6 % u 41.3 % għal pazjenti fuq 1000, 2000, jew 3000 mg ta' levetiracetam rispettivament u ta' 12.6 % għal pazjenti fuq il-plaċebo.
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10 %).
Maltese: La levetiracetam u lanqas il-prodott ewlieni tal-metaboliżmu ma jeħlu wisq mal-proteini tal-plażma (<10 %).
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: Ir-reazzjonijiet avversi kienu ppreżentati f'ordni ta' gravita` minn ħafna għal ftit u il-frekwenza fil-provi kliniċi giet mfissra b'dan il-mod: komuni hafna (≥1/10); komuni (>1/100 sa ≤1/10); mhux komuni (>1/1,000 sa ≤1/100); rari (≥1/10,000 sa ≤1/1,000); rari ħafna (≤1/10,000).
English: Levetiracetam Hospira 100 mg/ml sterile concentrate levetiracetam
Maltese: Levetiracetam Hospira 100 mg/ml konċentrat sterili levetiracetam
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
Maltese: • reazzjonijiet allerġiċi serji (DRESS, reazzjoni anafillattika [reazzjoni severa u importanti], edima ta' Quinke [nefħa fil-wiċċ, xofftejn u griżmejn]);
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation
Maltese: Attentat ta' suwiċidju, ħsibijiet suwiċidali, disturb psikotiku, imġieba abnormali, alluċinazzjoni, rabja, stat konfużjonali, attakki ta' paniku, responsabilità affettwata/xejriet fil-burdata, agitazzjoni
English: • rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase.
Maltese: • rabdomijolożi (it-tkissir ta' tessut tal-muskoli) u żieda assoċjata ta' creatine phosphokinase fiddemm.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Maltese: Is-sustanza attiva, levetiracetam hija derivat ta' pyrrolidone (S-enantiomer ta' α-ethyl-2- oxo-1pyrrolidine acetamide), u ma tixbahx kimikament lil sustanzi attivi oħrajn li jintużaw kontra l-epilessija.
English: Maximum dose: 30 mg/kg twice daily
Maltese: Doża massima: 30 mg/kg darbtejn kuljum
English: • pancreatitis (inflammation of the pancreas);
Maltese: • pankreatite (infjammazzjoni tal-frixa);
English: In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Maltese: Huwa wkoll jaqleb parzjalment it-tnaqqis f'kurrenti mxattba b'GABA u glycine indotti b'żingu u ß-carbolines.
English: Peak plasma concentration was observed 0.5 to 1.0 hour after dosing.
Maltese: Il-konċentrazzjoni massima fil-plażma kienet osservata f'0.5 sa 1.0 siegħa wara d-doża.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibli fil-preżent hija deskritta f'sezzjonijiet 4.8, 5.1, u 5.2 iżda ma jistgħux isiru rakkomandazzjonijiet fuq pożoloġija.
English: Each carton contains 10 or 25 vials.
Maltese: Kull kartuna fiha 10 jew 25 kunjett.
English: A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures.
Maltese: Studju ta' sigurtà fil-pedjatrija, ikkontrollat mill-plaċebo u double-blind b'disinn non-inferiority kejjel l-effetti kognittivi u newropsikoloġiċi ta' levetiracetam fi tfal ta' 4 sa 16-il sena ta' età b'aċċessjonijiet tat-tip partial onset.
English: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Maltese: Tagħrif minn studji kliniċi f'adulti li saru qabel ma ħareġ fis-suq, juri li levetiracetam ma kellu ebda effett fuq il-konċentrazzjonijiet fis-serum ta' mediċini eżistenti kontra l-epilessija (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin u primidone), u li dawn il-prodotti mediċinali ma kellhom ebda effett fuq il-profil farmakokinetiku ta' levetiracetam.
English: One vial of Levetiracetam Hospira concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Maltese: Kunjett wieħed ta' Levetiracetam Hospira fih 500 mg ta' levetiracetam (5 ml ta' konċentrat f'100 mg/ml).
English: Choreoathetosis, dyskinesia, hyperkinesia, gait disturbance, encephalopathy
Maltese: Kloreoatetosi, diskinesja, iperkinesja, disturbi filmixja, enċefalopatija