FrancophonIA/ELRC3.0 huggingface dataset:
English: A limited number of drug-drug pharmacokinetic interaction studies with Eurartesim have been performed in healthy adult subjects.
Maltese: Twettaq numru limitat ta' studji dwar l-interazzjoni farmaċewtika ta' Eurartesim f'individwi adulti b'saħħithom.
English: Due to its long elimination half-life, piperaquine accumulates after multiple dosing.
Maltese: Minħabba l-half-life twila tal-eliminazzjoni tiegħu, piperaquine jakkumula wara dożaġġ multiplu.
English: In a randomised trial in which 767 adults and children with uncomplicated P. falciparum malaria were exposed to Eurartesim, 25% of subjects were judged to have experienced an adverse drug reaction
Maltese: Fi prova li fiha l-parteċipanti ntgħażlu b'mod każwali, li fihom 767 persuna adulta u tfal li kellhom malarja mhux ikkumplikata minħabba P. falciparum, kienu esposti għal Eurartesim, 25% tal-individwi kienu ġġudikati li kellhom reazzjoni avversa tal-mediċina (ADR).
English: Hepatomegaly Abnormal liver function tests
Maltese: Epatomegalija Testijiet tal-funzjoni tal fwied b'riżultati mhux normali
English: Package leaflet: information for the user Eurartesim 320 mg/40 mg film-coated tablets
Maltese: Informazzjoni għall-utent Eurartesim 320 mg/40 mg pilloli miksija b'rita
English: In the tables below, ADRs are listed under system organ class (SOC), and ranked by headings of frequency.
Maltese: Fit-tabelli t'hawn taħt, ir-reazzjonijiet avversi tal-mediċina huma elenkati taħt il-klassi tal-organi tas-sistema (SOC) u kklassifikati skont intestaturi ta' frekwenza.
English: The most important potential cardiac effect was related to cardiac conduction.
Maltese: L-iktar effett kardijaku potenzjali importanti kien marbut mal-konduzzjoni kardijaka.
English: - Known congenital prolongation of the QTc-interval or any clinical condition known to prolong the QTc interval.
Maltese: - Titwil konġenitali magħruf tal-intervall tal-QTc jew kwalunkwe kundizzjoni klinika magħrufa li ttawwal l-intervall QTc.
English: • 30 minutes of taking Eurartesim, the whole dose must be taken again.
Maltese: • 30 minuta minn meta tkun ħadt Eurartesim, id-doża kollha trid tittieħed mill-ġdid.
English: Hepatomegaly
Maltese: Tromboċitemija
English: Leuckocytoses NEC Anaemia
Maltese: Il-pazjenti kollha ġew imfejqa klinikament.
English: Pyrexia
Maltese: Takikardija
English: There are no phototoxicity concerns with artenimol, as it does not absorb in the range of 290-700 nm. Piperaquine has an absorption maximum at 352 nm.
Maltese: 290-700 nm. Piperaquine għandu massimu ta' assorbiment f'352 nm.
English: Eurartesim has not been evaluated in patients with moderate or severe renal or hepatic insufficiency (see section 4.2).
Maltese: Eurartesim ma ġiex evalwat f'pazjenti b'insuffiċjenza moderata jew severa tal-kliewi jew tal-fwied (ara sezzjoni 4.2).
English: Clinical studies of Eurartesim did not include patients aged 65 years and over, therefore no dosing recommendation can be made.
Maltese: Studji kliniċi dwar il-pilloli Eurartesim ma kienux jinkludu pazjenti li kellhom 65 sena u iżjed, u għalhekk ma tista' ssir l-ebda rakkomandazzjoni dwar id-dożaġġ.
English: Influenza, respiratory infections, poor appetite or loss of appetite, dizziness, convulsions (fits), irregular or slow heart rate, cough, vomiting, abdominal pain, diarrhoea, nausea, inflammation or enlargement of the liver, abnormal liver function tests, itching, pain in the muscles or joints.
Maltese: Influwenza, infezzjoni respiratorja, aptit batut jew telf ta' aptit, sturdament, konvulżjonijiet (puplesiji), rata irregolari jew baxxa ta' taħbit tal-qalb, sogħla, rimettar, uġigħ ta' żaqq, dijarea, nawsja, infjammazzjoni jew tkabbir tal-fwied, testijiet tal-funzjoni tal-fwied b'riżultati mhux normali, ħakk, uġigħ fil-muskoli jew ġogi.
English: A total of 6 (0.8%) subjects had serious ADRs in the study.
Maltese: Total ta' 6 (0.8%) tal-individwi kellhom reazzjonijiet avversi serji fl-istudju.
English: • is taking other medicines that can have an effect on heart rhythm, such as: quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, hydroquinidine or sotalol; medicines used to treat depression such as amitriptyline, fluoxetine or sertraline; medicines used to treat mental health problems such as phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;
Maltese: • qegħdin tieħdu mediċini oħrajn li jista' jkollhom effett fuq ir-ritmu tal-qalb bħal; quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, hydroquinidine jew sotalol; mediċini li jintużaw biex jikkuraw id-dipressjoni bħal amitriptyline, fluoxetine jew sertraline;
English: 6 tablets Film-coated tablets.
Maltese: 6 pilloli Pilloli miksija b'rita.
English: Κύπρος
Maltese: Astenja
English: There is potential for neurotoxicity of artemisinin derivatives in man and animals, which is strongly related to the dose, route and formulations of the different artenimol pro-drugs.
Maltese: Hemm potenzjal għal newrotossiċità ta' derivati ta' artemisinin fil-bniedem u fl-annimali, li hi relatata bil-qawwa mad-doża, ir-rotta u l-formulazzjonijiet tal-pro-mediċini differenti ta' artenimol.
English: Eurartesim is contraindicated in patients already taking other medicinal products that are known to prolong the QTc interval due to the risk of a pharmacodynamic interaction leading to an additive effect on the QTc interval (see sections 4.3 and 4.4).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Eurartesim hu kontraindikat f'pazjenti li jkunu diġà qed jieħdu prodotti mediċinali oħrajn li huma magħrufa li jtawlu l-intervall tal-QTc minħabba r-riskju ta' interazzjoni farmakodinamika li twassal għal effett addittiv fuq l-intervall tal-QTc (ara sezzjonijiet 4.3 u 4.4).
English: Rhinorrhoea Epistaxis
Maltese: Popolazzjoni pedjatrika
English: Artenimol administration may result in a slight decrease in CYP1A2 activity.
Maltese: L-għoti ta' artenimol jista' jirriżulta fi tnaqqis żgħir fl-attività ta' CYP1A2.
English: Piperaquine did not induce malformation in rats and rabbits.
Maltese: Piperaquine ma kkawżax malformazzjoni fil-firien u fil-fniek.
English: tacrolimus); - sex hormones, including those contained in hormonal contraceptives (such as gestodene,
Maltese: tacrolimus); - ormoni tas-sess, li jinkludu dawk li jinsabu f'kontraċettivi ormonali (bħal gestodene,
English: Tablet strength and number of tablets per dose
Maltese: Numru totali ta' pilloli għall kura
English: Malaria is caused by infection with a parasite called Plasmodium, spread by the bite of an infected mosquito.There are different types of Plasmodium parasite.
Maltese: Hemm żewġ tipi differenti tal-parassita Plasmodium.
English: Thrombocythaemia Splenomegaly Lymphadenopathy Hypochromasia
Maltese: Studji in-vitro dwar il-metaboliżmu wrew li piperaquine hu mmetabolizzat minn epatoċiti tal-bniedem
English: • That there is a potential risk of teratogenicity and so Eurartesim should not be used in the 1st trimester of pregnancy in situations where other suitable and effective anti-malarials are available.
Maltese: • Li hemm ir-riskju potenzjali ta' teratoġeniċità u għalhekk Eurartesim m'għandux jintuża waqt lewwel trimestru tat-tqala f'sitwazzjonijiet fejn mediċini oħrajn adattati u effettivi kontra l malarja jkunu disponibbli.
English: - omeprazole (used to treat diseases related to gastric acid production); - paracetamol (used to treat pain and fever); - theophylline (used to improve bronchial air flow); - nefazodone (used to treat depression); - aprepitant (used to treat nausea); - some gases (such as enflurane, halothane and isoflurane) used to give a general anaesthetic.
Maltese: - aprepitant (jintuża biex jikkura n-nawseja); - xi gassijiet (bħal enflurane, halothane u isoflurane) li jintużaw għall-għoti ta' anestetiku ġenerali.
English: A tabular overview of the frequency of the ADRs in paediatric patients is given below.
Maltese: Deskrizzjoni tabulari fil-qosor tal-frekwenza tar-reazzjonijiet avversi tal-mediċina f'pazjenti pedjatriċi qed tingħata hawn taħt.
English: A course of Eurartesim lasts 3 consecutive days.
Maltese: Kors ta' Eurartesim idum tliet ijiem konsekuttivi.
English: The potential for Eurartesim to prolong the QTc interval was investigated in parallel groups of healthy volunteers who took each dose with high (~1000 Kcal) or low (~400 Kcal) fat/calorie meals or in fasting conditions.
Maltese: Il-potenzjal għal Eurartesim li jtawwal l-intervall QTc ġie mistħarreġ fi gruppi paralleli ta' voluntiera b'saħħithom li ħadu kull doża ma' ikel b'ammont għoli (~1000
English: - Recent treatment with medicinal products known to prolong the QTc interval that may still be circulating at the time that Eurartesim is commenced (e.g. mefloquine, halofantrine, lumefantrine, chloroquine, quinine and other antimalarial medicinal products) taking into account their elimination half-life.
Maltese: - Kura riċenti bi prodotti mediċinali li huma magħrufa li jtawlu l-intervall tal-QTc li jistgħu jkunu għadhom jiċċirkolaw fil-ħin li jinbeda Eurartesim (eż. mefloquine, halofantrine, lumefantrine, chloroquine, quinine u prodotti mediċinali oħra kontra l-malarja), u billi wieħed jikkunsidra l-half-life tal-eliminazzjoni tagħhom.
English: • Inhibition of the transporters that efflux chloroquine from the parasite food vacuole
Maltese: • Inibizzjoni tat-trasportaturi li jagħmlu l-effluss ta' chloroquine mill-vacuole tal-ikel tal-parassiti
English: Thrombocytopenia Leukopenia/neutrope nia
Maltese: Effetti fuq ir-ripolarizzazzjoni kardijaka
English: Frequency of ADRs in paediatric patients participating in clinical studies with Eurartesim:
Maltese: Frekwenza ta' reazzjonijiet avversi tal-mediċina f'pazjenti pedjatriċi li kienu qed jipparteċipaw fi studji kliniċi b'Eurartesim:
English: Chloroquine binds to toxic haeme (derived from the patient's haemoglobin) within the malaria parasite, preventing its detoxification via a polymerisation step.
Maltese: Chloroquine jeħel ma' eme tossiku (miskub mill-emoglobina tal-pazjent) fil-parassita tal-malarja, u jimpedixxi d-ditossifikazzjoni tiegħu permezz ta' pass ta' polimerizzazzjoni.
English: Contents of the pack and other information What Eurartesim contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Eurartesim
English: Therefore, particular caution is required if Eurartesim is administered to patients taking potent CYP3A4 inhibitors (e.g. some protease inhibitors [amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodone or verapamil), and ECG monitoring should be considered due to the risk of higher plasma concentrations of piperaquine (see section 4.4).
Maltese: (eż. xi inibituri tal-protease [amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodone jew verapamil), u monitoraġġ tal-ECG għandu jiġi kkunsidrat minħabba r-riskju ta' konċentrazzjonijiet ogħla ta' piperaquine fil-plażma (ara sezzjoni 4.4).
English: The active substances are piperaquine tetraphosphate and artenimol.
Maltese: Is-sustanzi attivi huma piperaquine tetraphosphate u artenimol.
English: QTc prolonged Tachycardia
Maltese: Tħaxwix kardijaku
English: Accordingly, Eurartesim should be administered with water no less than 3 hours after the last food intake, and no food should be taken within 3 hours after each dose (see section 4.2).
Maltese: Għaldaqstant, Eurartesim għandu jingħata flimkien mal-ilma mhux inqas minn 3 sigħat wara l-aħħar ikla, u l-ebda ikel m'għandu jittieħed sa 3 sigħat wara kull doża (ara sezzjoni 4.2).
English: Headache
Maltese: Konvulżjoni
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: 5 to less than 7 Half 160 mg/20 mg tablet a day
Maltese: 5 sa inqas minn 7 Nofs pillola ta' 160 mg/20 mg kuljum
English: 7 to less than 13 One 160 mg/20 mg tablet a day
Maltese: 7 sa inqas minn 13 Pillola waħda ta' 160 mg/20 mg kuljum
English: These include some of the types of medicines used to treat bacterial infections (macrolides [such as erythromycin or clarithromycin] and fluoroquinolones [such as moxifloxacin and sparfloxacin]) or fungal infections (including fluconazole and imidazole) as well as pentamidine (used to treat a specific type of pneumonia) and saquinavir (for treatment of HIV); antihistamines used to treat allergies or inflammation such as terfenadine, astemizole or mizolastine; certain medicines used to treat stomach problems such as cisapride, domperidone or droperidol; other medicines such as vinca alkaloids and arsenic trioxide (used to treat certain cancers), bepridil (used to treat angina), diphemanil (used to treat stomach disturbances), levomethadyl and methadone (used to treat drug addiction), and probucol (used to treat high blood cholesterol levels).
Maltese: ċerti mediċini li jintużaw biex jikkuraw problemi fl-istonku , bħal cisapride, domperidone jew droperidol; mediċini oħrajn bħal vinca alkaloids u arsenic trioxide (jintużaw għal kura ta' ċertu kanċers), bepridil (jintuża għal kura tal-anġina), diphemanil (jintuża għal kura ta' disturbi fl-istonku), levomethadyl u methadone (jintużaw għal kura ta' dipendenza fuq id-droga), u probucol (jintuża għal kura ta' livelli għolja ta' kolesterol fid-demm).
English: This increase in exposure to the antimalarial combination may result in an exacerbation of the effect on QTc (see section 4.4).
Maltese: Din iżżieda fl-esponiment għall-kombinazzjoni antimalarjali tista' tirriżulta f'aggravament tal-effett fuq ilQTc (ara sezzjoni 4.4).
English: Eurtartesim treatment, the piperaquine maximum plasma concentration was higher in female than in male healthy volunteers, the difference being in the order of 30 to 50%.
Maltese: Mill-banda l-oħra, fl-aħħar jum tal-kura b'Eurartesim, il-konċentrazzjoni massima ta' piperaquine fil-plażma kienet ogħla f'voluntiera b'saħħithom nisa milli f'voluntiera b'saħħithom irġiel, bid-differenza li kienet ta' bejn 30 sa 50%.
English: 3 tablets Film-coated tablets.
Maltese: 3 pilloli Pilloli miksija b'rita.
English: Stomatitis Nausea
Maltese: Tqala u treddigħ
English: 9 tablets Film-coated tablets.
Maltese: 9 pilloli Pilloli miksija b'rita.12-il pillola
English: The exact mechanism of action of piperaquine is unknown, but it likely mirrors that of chloroquine, a close structural analogue.
Maltese: Il-mekkaniżmu eżatt tal-azzjoni ta' piperaquine mhuwiex magħruf, iżda x'aktarx li hu l-istess bħal dak ta' chloroquine, analogu bi struttura simili.
English: >12 to ≤18 years >18 to ≤64 years DM04011 (n=1524) ≤1 year
Maltese: >12 sa ≤18-il sena
English: There are only limited (n=3) amount of data from the use of artenimol/piperaquine during the 1st trimester of pregnancy.
Maltese: Hemm biss ammont limitat (n=3) ta' dejta dwar l-użu ta' artenimol/piperaquine matul l-ewwel trimestru tat-tqala.
English: diazepam, alprazolam), zaleplon, zolpidem; - medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital),
Maltese: - mediċini li jintużaw biex jipprevjenu/jikkuraw puplesiji epilettiċi: barbiturates (bħal phenobarbital), carbamazepine jew phenytoin; - mediċini li jintużaw wara trapjant ta' organu u f'mard awtoimmuni (bħal cyclosporin,
English: The concurrent administration of a single dose of oral clarithromycin, (a strong CYP3A4 inhibitor probe) with a single dose of oral Eurartesim led to a modest increase (≤2-fold) in piperaquine exposure in healthy adult subjects.
Maltese: L-għoti fl-istess ħin ta' doża orali waħda ta' clarithromycin orali, (test b'impeditur qawwi ta' CYP3A4), b'doża orali waħda ta' Eurartesim wassal għal żieda modesta (≤ darbtejn) fl-esponiment ta' piperaquine f'individwi adulti b'saħħithom.
English: Any effects are unlikely to persist beyond 24 hours after the last intake of artenimol.
Maltese: Kwalunkwe effetti mhumiex mistennija li jippersistu għal aktar minn 24 siegħa wara l-aħħar teħid ta' artenimol.
English: Fertility
Maltese: Nawseja
English: The mean oral clearance for adult patients with malaria was 1.34 l/h/kg.
Maltese: Il-medja tat-tneħħija orali għal pazjenti adulti bil-malarja kienet ta' 1.34 l/siegħa/kg.
English: 36 to less than 75 Three 320 mg/40 mg tablets a day
Maltese: 36 sa inqas minn 75 Tliet pilloli ta' 320 mg/40 mg kuljum
English: Pharmacotherapeutic group: Antiprotozoals, antimalarials, Artemisinin and derivatives, combinations, ATC code: P01BF05.
Maltese: Antiprotożoali, mediċini kontra l-malarja, artemisinin u derivati,
English: Abnormalities in red blood cells, excessive numbers of platelets, enlargement of some organs (such as liver or spleen), swollen lymph glands, convulsions (fits), headache, abnormal heart sounds (heard by your doctor with a stethoscope), nose bleeds, runny nose, nausea, inflammation of the mouth, inflammation or enlargement of the liver, jaundice, abnormal liver function blood tests, skin itching and inflammation, pain in the joints.
Maltese: Anormalitajiet fiċ-ċelluli ħomor tad-demm, numru eċċessiv ta' plejtlits, tkabbir ta' xi organi (bħal fwied jew il-milsa), glandoli tal-limfa minfuħin, konvulżjonijiet (puplesiji), uġigħ ta' ras, ħsejjes mhux normali tal-qalb (li jinstemgħu mit-tabib tiegħek bi stetoskopju), ħruġ ta' demm mill-imnieħer, imnieħer inixxi, nawseja, infjammazzjoni tal-ħalq, infjammazzjoni jew tkabbir tal-fwied, suffejra, testijiet tad-demm tal-funzjoni tal-fwied b'riżultat mhux normali, ħakk u infjammazzjoni tal-ġilda, uġigħ fil-ġogi.
English: If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.
Maltese: Jekk ikun diffiċli li tibla' l-pilloli, tista' tfarrakom u tħallathom mal-ilma; ixrob it-taħlita immedjatament.
English: Literature data concerning chronic toxicity of piperaquine in dogs and monkeys indicate some hepatotoxicity and mild reversible depression of total white cell and neutrophil counts.
Maltese: Dejta mil-letteratura dwar it-tossiċità kronika ta' piperaquine fil-klieb u fix-xadini tindika xi epatotossiċità u tnaqqis ħafif riversibbli tal-għadd totali ta' ċelluli bojod u newtrofili.
English: >5 to ≤12 years
Maltese: >18 sa ≤64 sena
English: Examples are listed in the section “Other medicines and Eurartesim”.
Maltese: Eżempji huma elenkati fis-sezzjoni “Mediċini oħra u Eurartesim”.
English: • Inhibition of haem-digestion pathway in the parasite food vacuole.
Maltese: • Inibizzjoni tal-passaġġ tad-diġestjoni tal-eme fil-vacuole tal-ikel tal-parassiti.
English: Acanthosis Pruritis
Maltese: toraċiċi u medjastinali
English: Absorption of piperaquine is increased in the presence of fatty food (see sections 4.4 and 5.2) which may increase its effect on QTc interval.
Maltese: L-assorbiment ta' piperaquine jiżdied fil-preżenza ta' ikel li jkun fih ix-xaħam (ara sezzjonijiet 4.4 u 5.2), li jista' jżid l-effett tiegħu fuq l-intervall QTc.
English: Analysis of cardiac adverse events in clinical trials showed that these were reported more frequently in Eurartesim treated patients than in those treated with comparator antimalarial (see section 4.8).
Maltese: Analiżi ta' każijiet kardijaċi avversi fil-provi kliniċi wriet li dawn kienu rrappurtati aktar b'mod frekwenti f'pazjenti kkurati b'Eurartesim milli f'dawk ikkurati b'komparaturi kontra l-malarja (ara sezzjoni 4.8).
English: Convulsion Headache
Maltese: Artralġja
English: − fluoroquinolones (e.g. moxifloxacin, sparfloxacin),
Maltese: • Ċerti prodotti mediċinali kontra l-mikrobi li jinkludu xi prodotti mediċinali tal-klassijiet li ġejjin: - macrolides (eż. erythromycin, clarithromycin), - fluoroquinolones (eż. moxifloxacin, sparfloxacin),
English: The age-specific PCR-corrected cure rates in the m-ITT populations are tabulated below for the Asian and African studies, respectively:
Maltese: Rati ta' kura kkoreġuti għal PCR speċifiċi għall-età fil-popolazzjonijiet m-ITT huma tabulati hawn taħt għall-istudji Asjatiċi u Afrikani, rispettivament:
English: Anaemia, headache, heart rhythm disturbances (ECG changes or noticing unusually fast heart beats or palpitations), fever, general weakness.
Maltese: Anemija, uġigħ ta' ras, disturbi fir-ritmu tal-qalb (tibdil fl-ECG jew tinnota taħbit tal-qalb mgħaġġel b'mod mhux tas-soltu, jew palpitazzjonijiet), deni, dgħufija ġenerali.
English: In perinatal and postnatal studies in rats, piperaquine was associated with delivery complications.
Maltese: Fi studji ta' qabel u wara t-twelid fil-firien, piperaquine kien assoċjat ma' kumplikazzjonijiet waqt ilħlas.
English: Compared to adult males, female patients and elderly patients have longer QTc intervals.
Maltese: Meta mqabbla ma' rġiel adulti, pazjenti nisa u pazjenti anzjani għandhom intervalli tal-QTc itwal.
English: There are no specific data relating to the effects of piperaquine on fertility, however, to date no adverse events have been reported during clinical use.
Maltese: Fertilità M'hemm l-ebda dejta speċifika relatata mal-effetti ta' piperaquine fuq il-fertilità, madankollu, l-ebda effetti avversi ma kienu rrappurtati matul użu kliniku.
English: EU/2/11/127/001 Recuvyra 50 mg/ml Transdermal
Maltese: EU/2/11/127/001 Recuvyra 50 mg/ml Soluzzjoni
English: 1 vial + 1 adapter + 15 syringes + 15 applicator tips
Maltese: 1 kunjett + 1 adapter + 15-il siringa + 15-il ras t'applikatur
English: Invented Name administration
Maltese: Mod t'amministrazzj oni
English: Dogs Transdermal use Vial (glass) 10 ml
Maltese: Klieb Użu transdermali Kunjett (ħġieġ)
English: Packaging Content Package size Withdrawal period
Maltese: Iġġakkjar Kontenut Daqs tal-pakkett Perjodu ta' tiżmin
English: It may harm them,
Maltese: Insuffiċjenza epatika,
English: - The active substance is levetiracetam.
Maltese: - Is-sustanza attiva hi levetiracetam.
English: Suomi/Finland ratiopharm Oy puh./tel.
Maltese: Suomi/Finland ratiopharm Oy puh.
English: 2031GA Haarlem The Netherlands
Maltese: 2031GA HaarlemL-Olanda
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK United Kingdom
Maltese: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Maltese: Nekroliżi epidermali tossiku, sindromu ta' Stevens-Johnson, eritema multiforme
English: Respiratory,
Maltese: Disturbi respiratorji,
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: Tablet core: maize starch, povidone, croscarmellose sodium and magnesium stearate.
Maltese: Il-qalba tal-pillola: maize starch, providone, croscarmellose soidum, u magnesium stearate.
English: 10 to 20 mg/kg once daily (3) (5)
Maltese: 10 sa 20 mg/kg darba kuljum (3) (5)
English: Each Levetiracetam Teva 250, 500, 750, 1,000 mg film-coated tablet contains 250, 500, 750, 1,000 mg levetiracetam.
Maltese: Kull Levetiracetam Teva 250, 500, 750, 1,000 mg pillola miksija b'rita fiha 250, 500, 750, 1,000 mg levetiracetam.
English: Debossed with "7493" on the other side of the tablet.
Maltese: Hemm imnaqqax “7493” fuq in-naħa l-oħra tal-pillola.
English: • elevated/abnormal values in a liver function test;
Maltese: • valuri għolja/ abnormali fit-test tal-funzjoni tal-fwied;
English: Date of first authorisation: 26 August 2011 Date of latest renewal: 15 July 2016
Maltese: Data tal-aħħar tiġdid: 15 ta' Lulju 2016
English: Levetiracetam Teva 750 mg contains Sunset Yellow
Maltese: Levetiracetam Teva 750 mg fih Sunset Yellow
English: Transparent PVC/PVdC - aluminium blisters.
Maltese: Folji tal-aluminju - PVC/PVdC trasparenti.
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: Levitiracetam 1,000 mg kuljum ma kellux effett fuq il-farmakokinetika ta' kontraċettivi orali (ethinylestradiol u levonorgestrel); il-parametri endokrinali (luteinizing hormone u progesterone) ma kinux mibdulin.