FrancophonIA/ELRC3.0 huggingface dataset:
English: * The confidence intervals were calculated with no adjustment for age category (< 55 years, ≥ 55 years) and investigator group, which were included in the primary analysis of odds ratios and logistic models.
Maltese: 25-120 siegħa * L-intervalli ta' kunfidenza ġew ikkalkulati bla ebda aġġustament għall-kategorija t'età (< 55 sena, ≥ 55 sena) u għall-grupp tal-investigatur, li kienu inklużi fl-analiżi primarja tal-odds ratios u mudelli loġistiċi.
English: A population pharmacokinetic analysis of aprepitant in paediatric patients (aged 6 months through 17 years) suggests that gender and race have no clinically meaningful effect on the pharmacokinetics of aprepitant.
Maltese: Analiżi farmakokinetika ta' popolazzjoni ta' aprepitant f'pazjenti pedjatriċi (ta' età minn 6 xhur sa 17-il sena) tissuġġerixxi li s-sess tal-persuna u r-razza m'għandhom l-ebda effett ta' sinifikat kliniku fuq il-farmakokinetika ta' aprepitant.
English: Do not give EMEND 80 mg and 125 mg capsules to children under 12 years of age, because the 80 mg and 125 mg capsules have not been studied in this population.
Maltese: Tagħtix kapsuli ta' EMEND 80 mg u 125 mg lil tfal taħt l-età ta' 12-il sena, minħabba li l-kapsuli ta' 80 mg u 125 mg ma ġewx studjati f'din il-popolazzjoni.
English: Do not remove all capsules at one time.
Maltese: Ibla' l-kapsula sħiħa ma' ftit likwidu.
English: There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment.
Maltese: Hemm data limitata dwar pazjenti b'indeboliment epatiku moderat u ma teżisti l-ebda data dwar pazjenti b'indeboliment epatiku serju.
English: terfenadine, astemizole, or cisapride (see section 4.3).
Maltese: Għoti flimkien ma' pimozide, terfenadine, astemizole jew cisapride (ara sezzjoni 4.5).
English: Sachet for EMEND 125 mg powder for oral suspension
Maltese: INFORMAZZJONI BIL-BRAILLE EMEND 125 mg trab għal suspensjoni orali
English: Dexamethasone: The usual oral dexamethasone dose should be reduced by approximately 50 % when co-administered with EMEND 125 mg/80 mg regimen.
Maltese: Id-doża ta' dexamethasone orali li ġeneralment tingħata għandha titnaqqas b'madwar 50 % meta mogħtija flimkien ma' kors ta' EMEND 125 mg/80 mg.
English: During continuous treatment with methylprednisolone, the AUC of methylprednisolone may decrease at later time points within 14 days following initiation of the EMEND dose, due to the inducing effect of aprepitant on CYP3A4.
Maltese: Waqt kura kontinwa b'methylprednisolone, l-AUC ta' methylprednisolone tista' tonqos f'ċertu ħin aktar tard, fi żmien 14-il jum minn wara l-bidu tad-doża b'EMEND, minħabba l-effett induttiv ta' aprepitant fuq CYP3A4.
English: The frequency categories given in the table are based on the studies in adults; the observed frequencies in the paediatric studies were similar or lower, unless shown in the table.
Maltese: Il-kategoriji ta' frekwenza mogħtija fit-tabella huma bbażati fuq l-istudji fl-adulti; ilfrekwenzi osservati fl-istudji pedjatriċi kienu simili jew kienu inqas, ħlief jekk dawn qed jintwerew fittabella.
English: EMEND 125 mg powder for oral suspension Aprepitant
Maltese: TAL-PRODOTT MEDIĊINALI EMEND 125 mg trab għal suspensjoni orali
English: The recommended dose of capsules of EMEND is 125 mg orally on Day 1 and 80 mg orally on Days 2 and 3.
Maltese: EMEND 125 mg f'Jum 1 u 80 mg kuljum fil-Jiem 2 sa 5.
English: Based on a comparable pharmacokinetic/pharmacodynamic profile, the 1-day oral regimen of EMEND 165 mg is anticipated to have a similar efficacy profile to that of the 1-day regimen of fosaprepitant 150 mg and 3-day regimen of oral aprepitant (see section 5.2)
Maltese: Fuq bażi li l-profil farmakokinetiku/farmakodinamiku jixxiebah, l-iskeda ta' għoti ta' 165 mg ta' EMEND mill-ħalq għal jum wieħed biss huwa mistenni li jkollu profil ta' effikaċja jixbah lil dak taliskeda ta' għoti ta'150 mg ta' fosaprepitant għal jum wieħed biss u tal-iskeda ta' għoti ta' 150 mg ta' aprepitant mill-ħalq għal 3 ijiem (ara sezzjoni 5.2).
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, assorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: Pour the entire contents of the sachet into the 4.6 mL of water in the mixing cup and snap the lid shut.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Method of administration The hard capsule should be swallowed whole.
Maltese: Metodu ta' kif għandu jingħata Il-kapsula iebsa għandha timbela sħiħa.
English: Effect of other medicinal products on the pharmacokinetics of aprepitant Concomitant administration of EMEND with active substances that inhibit CYP3A4 activity (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, and protease inhibitors) should be approached cautiously, as the combination is expected to result in several-fold increased plasma concentrations of aprepitant (see section 4.4).
Maltese: ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone u inibituri tal-protease) għandu jsir b'kawtela billi flimkien dawn huma mistennija li jirriżultaw f'konċentrazzjonijiet bosta drabi ogħla ta' aprepitant fil-plażma (ara sezzjoni 4.4).
English: The potential for reproductive toxicity of aprepitant has not been fully characterised, since exposure levels above the therapeutic exposure in humans at the 125 mg/80 mg and 165 mg doses could not be attained in animal studies.
Maltese: Il-possibbiltà li aprepitant jikkawża tossiċità riproduttiva għadu ma ġiex ikkaratterizzat kompletament, minħabba li livelli ta' esponiment ogħla mil-livell ta' esponiment terapewtiku fil-bniedem bid-dożi ta' 125 mg/80 mg u 165 mg ma setgħux jintlaħqu fl-istudji bl-annimali.
English: †Difference and confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for Gender.
Maltese: †Id-Differenza u l-confidence interval (CI) ġew ikkalkulati bl-użu tal-metodu ssuġġerit minn Miettinen u Nurminen u aġġustat għas-Sess tal-persuna.
English: The color of the medicine in the oral dispenser may be different shades of pink (light pink to dark pink).
Maltese: Il-kulur tal-mediċina fid-dispenser orali jista' jkun varjazzjonijiet differenti ta' roża (minn roża ċar sa roża skur).
English: See enclosed leaflet for additional information about how to take EMEND.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: Rare side effects (may affect up to1 in 1,000 people) are: - difficulty thinking, lack of energy, taste disturbance, - sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching rash,
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000): - diffikultà biex taħseb, nuqqas ta' enerġija, disturb fit-togħma, - sensittività tal-ġilda għax-xemx, għaraq żejjed, ġilda żejtnija, ġrieħi fil-ġilda, raxx bil-ħakk,
English: EMEND 40 mg hard capsules are supplied in the following pack sizes: - Aluminium blister containing one 40 mg capsule - 5 Aluminium blisters each containing one 40 mg capsule
Maltese: Il-kapsuli ta' 40 mg huma opaki b'għamla bajda u b'kappa safra kulur il-mustarda b'“464” u “40 mg” stampati b'mod radjali b'linka sewda fuq il-korp.
English: Table 3 Percent of adult patients responding by treatment group and phase for Study 2 - Cycle 1 Moderately Emetogenic Chemotherapy
Maltese: Perċentwali ta' pazjenti adulti li jirrispondu skont il-grupp u fażi ta' kura - Ċiklu 1 Kimoterapija Moderatament Emetoġenika
English: Your doctor has prescribed EMEND, an anti-emetic, to help prevent nausea and vomiting associated with chemotherapy.
Maltese: It-tabib tiegħek ippreskriva EMEND, mediċina anti-emetika, sabiex jiġu evitati n-nawseja u r-rimettar assoċjati mal-kimoterapija.
English: The mean peak plasma concentration (Cmax) of aprepitant occurred at approximately 4 hours (tmax).
Maltese: L-ogħla konċentrazzjoni medja (Cmax) ta' aprepitant fil-plażma seħħet f'madwar 4 sigħat (tmax).
English: The powder for oral suspension is used in children aged 6 months to less than 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).
Maltese: It-trab għal suspensjoni orali jintuża fi tfal ta' età minn 6 xhur sa inqas minn 12-il sena f'kombinazzjoni ma' mediċini oħrajn biex jimpedixxu nawsja u rimettar ikkawżati minn kimoterapija (kura kontra l-kanċer) li tikkaġuna nawsja u rimettar qawwi u moderat (bħal cisplatin, cyclophosphamide, doxorubicin jew epirubicin).
English: The fosaprepitant regimen consisted of fosaprepitant 150 mg on Day 1 in combination with intravenous ondansetron 32 mg on Day 1 and dexamethasone 12 mg on Day 1, 8 mg on Day 2, and 8 mg twice daily on Days 3 and 4.
Maltese: ondansetron minn ġol-vini fil-Jum 1 u 12-il mg ta' dexamethasone fil-Jum 1, 8 mg fil-Jum 2, u 8 mg darbtejn kuljum fil-Jiem 3 u 4.
English: Gastrointestinal disorders abdominal pain upper, bowel sounds abnormal, dry mouth, nausea, stomach discomfort, constipation*, sub-ileus*
Maltese: mijożi, nawsja, disturbi fis-sensi, skonfort fl-istonku, sub-ileus*, tnaqqis fl-akutezza tal-vista, tisfir fis sider.
English: Co-rapporteur:
Maltese: Ko-rapporteur(s):
English: Opinion date:
Maltese: Data tal-bidu tar-referenza:
English: 5 October 2010
Maltese: 19 ta' Novembru 2009
English: Daniela Melchiorri (Italy)
Maltese: Catherine Moraiti (Il-Greċja)
English: 20 May 2010
Maltese: Londra, 15 ta' Marzu 2010
English: It consists of tablets containing 35 mg risedronate sodium, together with sachets of effervescent granules containing 1000 mg calcium as calcium carbonate and 880 IU colecalciferol).
Maltese: Mistoqsijiet u tweġibiet dwar ir-riferiment għal Lescol u l-ismijiet assoċjati Kapsuli li fihom 20 mg jew 40 mg fluvastatina Pilloli b'rilaxx imtawwal li fihom 80 mg fluvastatin
English: Kristina Dunder (Sweden)
Maltese: Alar Irs (L-Estonja)
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Maltese: Artikolu 30 tad-Direttiva 2001/83/KE kif emendat, referenza fuq il-bażi ta' deċiżjonijiet diverġenti adottati minn Stati Membri
English: What is Fortipan Combi D?
Maltese: X'inhu Lescol?
English: Fortipan Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol (vitamin D3).
Maltese: Billi timblokka din l-enzima, il-livell tal-kolesterol fid-demm jonqos.
English: Warner Chilcott UK Ltd submitted Fortipan Combi D for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 October 2006.
Maltese: It-tweġibiet tal-kumpanija ngħataw: 29 ta' Mejju 2009, 16 ta' Ottubru 2009 Data tal-opinjoni:
English: Fortipan Combi D is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Lescol u l-ismijiet assoċjati.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Fortipan Combi D. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Fortipan Combi D outweigh its risks, and that the marketing authorisation granted in Sweden can be recognised in Italy.
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jenħtieġ li linformazzjoni dwar il-preskrizzjoni għal Lescol u l-ismijiet assoċjati tiġi armonizzata kemm fl-Unjoni Ewropea (UE) u kemm fin-Norveġja u fl-Islanda.
English: Why was Fortipan Combi D reviewed?
Maltese: Għaliex ġie rivedut Lescol?
English: The active substances in the effervescent granules provide calcium and vitamin D, which are needed for normal bone formation.
Maltese: Lescol fih is-sustanza attiva fluvastatina.
English: Ecupharma S.r.l Tel : +39-02-38238790
Maltese: S.r.l Tel : +39-02-38238790
English: •Sodium chloride (0.9 %) injection
Maltese: • injezzjoni ta' sodium chloride (0.9%)
English: • Lactated Ringer's injection
Maltese: • injezzjoni ta' Lactated Ringer
English: •Dextrose 5 % injection
Maltese: • injezzjoni ta' Dextrose 5%
English: Matever contains sodium
Maltese: Matever fih sodium
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: Each film-coated tablet contains 3.8 mg lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 3.8 mg lactose monohydrate.
English: • Sodium chloride (0.9 %) injection
Maltese: injezzjoni ta' sodium chloride (0.9%)
English: Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300
Maltese: Pallini 15351, Attiki, Il-Greċja Tel.: +30 210 66 04 300
English: Diluents:
Maltese: Dilwenti:
English: 2D barcode carrying the unique identifier included.
Maltese: 2D barcode li jkollu l-identifikatur uniku inkluż.
English: Tablet core: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, crospovidone type A, hydroxypropylcellulose (L).
Maltese: Il-qalba: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, crospovidone (type A), hydroxypropylcellulose (L).
English: More than half of the subjects remained seizure free for 12 months (56.6 % and 58.5 % of subjects on levetiracetam and on carbamazepine CR respectively).
Maltese: Iżjed minn nofs il-pazjenti baqaw mingħajr aċċessjonijet għal 12 il-xahar ( 56.6 % u 58.5 % tal-pazjenti fuq levetiracetam u fuq carbamazepine CR rispettivament).
English: • amnesia (loss of memory),memory impairment (forgetfulness), abnormal coordination/ataxia
Maltese: • amneżija (telf ta' memorja),impediment tal- memorja (tinsa), ko-ordinazzjoni abnormali/ataxja
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 ittrattamenti kienet ta' 0.2 %(95 % CI:-7.8 8.2).
English: 500 mg/5 ml
Maltese: INDIVIDWALI 500 mg/5ml
English: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Water for injections
Maltese: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Ilma għall-injezzjonijiet
English: Immune system disorders
Maltese: Disturbi fias-sistema immuni
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Maltese: Amneżija, impediment tal-memorja, koordinazzjoni abnormali/ataxja, paraestesija, disturbi fl' attenzjoni
English: Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritability
Maltese: Depressjoni, ostilita`/ aggressjoni, anzjeta, insomnja, nervożita`/irritabilta`
English: 43.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo were considered as responders.
Maltese: 43.6 % tal-pazjenti trattati b'levetiracetam u 19.6 % talpazjenti fuq plaċebo kienu kkonsidratai bħala li rrispondew.
English: (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
Maltese: (impediment fil-movimenti ko-ordinati), paraesteżja (tingiż), disturbi fl-attenzjoni (telf ta'konċentrazzjoni);
English: Matever 250 mg, 750 mg tablets contain Sunset Yellow FCF (E110) Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.
Maltese: Matever 250mg, 750 mg pilloli fihom Sunset Yellow FCF (E110) Sunset Yellow FCF (E110) sustanza li tgħati l-kulur tista' tikkawża reazzjonijiet allerġiċi.
English: One vial of Matever concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Maltese: Vjala waħda ta' Matever fiha 500 mg ta' levetiracetam (5 ml ta' konċentrat ta' 100 mg/ml ).
English: White opaque PVC/PE/PVDC-Aluminium foil blister in cardboard boxes.
Maltese: Abjad opak PVC / PE / PVDC-Aluminju fojl f'kaxxi tal-kartun.
English: CLcr (ml/min)= ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Maltese: Clcr (ml/min) = ------------------------------------------------ (x 0.85 għan-nisa) 72 x livell ta' krejatinina fis-serum (mg/dl)
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Maltese: Clcr (ml/min)= ------------------------------------------------ (x 0.85 għan-nisa) 72 x livell ta' krejatinina fis-serum (mg/dl)
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Maltese: Reazzjoni għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS), Ipersensittivita' (inkluż anġjoedima u anafilassi)
English: Pancytopenia neutropenia, agranulocytosis
Maltese: Pansitopenja newtropenja, agranuloċitożi
English: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily
Maltese: 500 sa 1,500 mg darbtejn kuljum 500 sa 1,000 mg darbtejn kuljum 250 sa 750 mg darbtejn kuljum 250 sa 500 mg darbtejn kuljum 500 to 1,000 mg darba kuljum
English: 6, Dervenakion EL-15351 Pallini Attiki Greece
Maltese: 6, Dervenakion str., 153 51 Pallini Attiki, Il-Greċja
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 1000, 2000 or 3000 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: One vial contains 500 mg/5 ml levetiracetam.
Maltese: Vjala waħda fiha 500 mg /5 ml levitiracetam.
English: DATE OF REVISION OF THETEXT
Maltese: DATA TA' REVIŻJONI TAT-TEST
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: Kontraċettivi orali u interazzjonijiet farmakokinetiċi oħra Levetiracetam 1,000 mg me kellu ebda effett fuq il-farmakokinetika ta' kontraċettivi orali (ethinylestradiol u levonorgestrel); parametric endokrinarji ( luteinizing hormone u progesterone).
English: The intravenous administration of doses up to 4000 mg diluted in 100 ml of 0.9 % sodium chloride infused over 15 minutes and doses up to 2500 mg diluted in 100 ml of 0.9 % sodium chloride infused over 5 minutes was evaluated.
Maltese: Kienu evalwati, it-teħid minn ġol-vina ta' dożi sa 4000 mg miżjudin b' 100 ml ta' 0.9 % sodium chloride b'infużjoni f' 15 il-minuta u dożi sa 2500 mg miżjudin b' 100 ml ta' 0.9 % sodium chloride b'infużjoni f' 5 minuti.
English: Film-coating: hypromellose (E464), titanium dioxide (E171), hydroxypropyl cellulose (E463), propylene glycol (E1520), sorbic acid (E200), sorbitan monooleate (E494), vanillin, colourants*.
Maltese: Film-coating: hypromellose (E464), titanium dioxide (E171), hydroxypropyl cellulose (E463), propylene glycol (E1520), sorbic acid (E200), sorbitan monuleat (E494),), vanillin, sustanza li jagħtu l-kulur*.
English: Sorbitan monooleate (E494) Titanium dioxide (E171) Vanillin.
Maltese: Titanium dioxide (E171) Vanillin.
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: 1500 mg twice daily Children 25 kg or less should preferably start the treatment with levetiracetam 100 mg/ml oral solution.
Maltese: 1500 mg darbtejn kuljum Tfal ta' 25 kg jew inqas għandhom preferabilment jibdew it-trattament b' Matever 100 mg/ml soluzzjoni orali.
English: General dose: between 1000 mg and 3,000 mg each day.
Maltese: Doża normali: bejn 1,000 mg u 3,000 mg kuljum.
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 anafilattika [reazzjoni allerġika severa u importanti], edima ta' Quincke [nefħa fil-wiċċ, xofftejn u griżmejn]);
English: • elevated/abnormal values in a liver function test;
Maltese: • valuri għolja/ abnormali fit-test tal-funzjoni tal-fwied ;
English: Coating agent (blue) consisting of: Hypromellose (E464) Titanium dioxide (E171) Talc
Maltese: Aġent għall-kisin (blu) li jikkonsisti minn: Hypromellose (E464) Titanium dioxide (E171) Talc
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms;
Maltese: • enċefalopatija (ara sottosezzjoni “Għid lit-tabib tiegħek immedjatament” għal deskrizzjoni dettaljata tas-sintomi);
English: Component of a multipack, can't be sold separately.
Maltese: Part minn pakkett multiplu, ma jistax jinbiegħ separatament.
English: Choreoathetosis, dyskinesia, hyperkinesia, gait disturbance, encephalopathy
Maltese: Koreoatetożi, diskinesija, iperkinesja, diffikultà filmixi, enċefalopatija
English: Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Greece
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Pharmathen S.A, 6 Dervenakion Str., 15351 Pallini, Attiki, Il-Greċja.
English: Contains sunset yellow FCF aluminum lake (E110).
Maltese: TA' EĊĊIPJENTI Fih sunset yellow FCF aluminium lake (E110).
English: The mechanism of this risk is not known.
Maltese: Ilmekkaniżmu ta' dan ir-riskju mhux magħruf.
English: Suomi/Finland Orion Pharma.
Maltese: Suomi/Finland Orion Pharma Puh/Tel:
English: Multipack: 200 (2 packs of 100) film-coated tablets
Maltese: Pakkett b'ħafna: 200 (2 pakketti b'100) pillola miksija b'rita
English: Toxic epidermal necrolysis, StevensJohnson syndrome, erythema multiforme
Maltese: Nekroliżi epidermali tossiku, sindromu ta' StevensJohnson,
English: The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults (0.96 ml/min/kg).
Maltese: Ir-riżultati farmakokinetiċi wrew li l-half-life kien iqsar (5.3 h) minn dak fl-adulti (7.2 h) u l-clearance li deher kien iżjed mgħaġġel ( 1.5 ml/min/kg) minn dak fladulti (0.96 ml/min/kg).
English: Contains lactose.
Maltese: ma kienux mibdulin.
English: Film-coating: hypromellose (E464), iron oxide red (E172), macrogol/PEG 4000, titanium dioxide (E171), colourants*.
Maltese: Film-coating: hypromellose (E464), , iron oxide red (E172), macrogol /PEG 4000, titanium dioxide (E171), sustanza li jagħtu l-kulur*.
English: • Dose in adults and adolescents (from 16 years of age): General dose: between 1,000 mg and 3,000 mg each day.
Maltese: • Doża fl-adulti u addoloxxenti (minn 16-il sena): Doża normalii: bejn 1000 mg u 3000 mg kuljum.
English: Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Maltese: Levetiracetam 2,000 mg kuljum ma kellux effett fuq il-farmakokinetika ta' digoxin u warfarin; ma kienux mibdulin il-prothrombin times.
English: Four embryo-fetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 mg/kg/day.
Maltese: Erba' studji dwar l-iżvillup tal-embriju u l-fetu saru fil-fniek li koprew dożi ta' 200, 600, 800, 1200 u 1800 mg/kg/ġurnata.