FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with Holoclar (seen in more than 1 patient in 10) is blepharitis (inflammation of the eye lid).
Maltese: L-effett sekondarju l-aktar komuni b'Holoclar (li jista' jaffettwa aktar minn persuna 1 minn kull 10) huwa blefarite (infjammazzjoni tal-kappell tal-għajnejn).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Holoclar treatment was effective in restoring healthy corneal surfaces in patients with moderate or severe limbal stem-cell deficiency caused by burns as well as in improving their symptoms and vision.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-kura b'Holoclar kienet effettiva fir-restawr tal-uċuh korneali b'saħħithom f'pazjenti b'nuqqas ta' ċelloli staminali limbali moderat sa sever ikkawżat minn ħruq kif ukoll fit-titjib tas-sintomi u tal-viżta tagħhom.
English: Antibiotics to prevent eye infection should be given to patients after limbal tissue has been taken from them.
Maltese: Għandhom jingħataw antibijotiċi li jipprevjenu infezzjoni tal-għajn lill-pazjenti wara li jitteħdilhom tessut limbali.
English: In addition, the company that makes Holoclar will provide healthcare professionals with educational material on the safe use of this treatment, including on the selection and follow-up of patients and on reporting side effects.
Maltese: Barra minn hekk, il-kumpanija li tagħmel Holoclar ser tipprovdi lill-professjonisti tal-kura tas-saħħa b'materjal edukattiv dwar l-użu sigur ta' din il-kura, inkluż dwar l-għażla u follow-up ta' pazjenti u dwar ir-rapportar ta' effetti sekondarji.
English: Thawed cells are used to make Holoclar by growing them on a membrane made of a protein called fibrin.
Maltese: Ċelloli li jinżlu wara li jkunu ġew iffriżati jintużaw biex isir Holoclar billi jiġu mkabbra fuq membrana magħmula minn proteina msejħa fibrin.
English: Educational material will also be provided to patients undergoing treatment.
Maltese: Ser jiġi pprovdut ukoll materjal edukattiv lil pazjenti li jkunu qed jingħataw kura.
English: 06 August 2014
Maltese: 06 ta' Awissu 2014
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura skont l-Artikolu 29(4) ta' Direttiva 2001/83/KE
English: EMA/709170/2013
Maltese: pillola 5 mg) EMA/709170/2013
English: Dexamed is a medicine that contains the active substance dexamfetamine sulphate.
Maltese: Dexamed huwa mediċina li fiha s-sustanza attiva dexamfetamine sulphate.
English: What is Dexamed?
Maltese: X'inhu Dexamed?
English: On 22 May 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamed (dexamfetamine sulphate).
Maltese: Fit-22 ta' Mejju 2014, l-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Dexamed (dexamfetamine sulphate).
English: It is to be available as tablets (5 mg) for the treatment of children between 6 and 17 years of age who have attention deficit hyperactivity disorder (ADHD) and in whom methylphenidate (another medicine for ADHD) was not effective (second-line treatment).
Maltese: Sejjer ikun disponibbli bħala pilloli (5 mg) għall-kura ta' tfal ta' età bejn 6 u 17-il sena li għandhom disturb ta' defiċit t'attenzjoni u iperattività (ADHD) u li fuqhom il-methylphenidate (mediċna oħra għal ADHD) ma kinitx effettiva (kura tat-tieni linja).
English: ADHD is a condition that mainly affects children, resulting in a persistent inability to concentrate, hyperactivity and impulsive behaviour.
Maltese: ADHD hija kundizzjoni li primarjament taffetwa lit-tfal, u twassal għallinabilità persistenti ta' konċentrazzjoni, iperattività u mġiba impulsiva.
English: This is a procedure where one European country (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other European countries (the ‘concerned Member States', in this instance Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain, and Sweden).
Maltese: Din hi proċedura fejn pajjiż Ewropew wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ ir-Renju Unit) jevalwa l-mediċina bil-ħsieb li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll f'pajjiż Ewropej oħrajn (l-‘Istati Membri kkonċernati', f'dan il-każ idDanimarka, il-Finlandja, l-Irlanda, il-Lussemburgu, il-Pajjiżi l-Baxxi, in-Norveġja, Spanja u l-Isvezja).
English: These conclusions were supported by a group of experts in childhood and adolescent behavioural problems consulted by the CHMP.
Maltese: Dawn il-konklużjonijiet kienu appoġġjati minn grupp ta' esperti fi problemi komportamentali fit-tfulija u l-adolexxenti kkonsultat mis-CHMP.
English: Kohne Pharma GmbH submitted Dexamed to the UK medicines regulatory agency for a decentralised procedure.
Maltese: Kohne Pharma GmbH ippreżentat Dexamed lill-aġenzija regulatorja tal-mediċini tar-Renju Unit għal proċess deċentralizzat.
English: The experts' group advised that while there is some evidence that medicines of the same type as Dexamed are more likely to induce dependence than other treatments for ADHD, based on clinical practice the risk of developing dependence in patients treated with dexamfetamine is considered to be low and could be adequately managed with appropriate risk minimisation measures.
Maltese: Il-grupp ta' esperti rrakkomanda li filwaqt li hemm xi evidenza li mediċini talistess tip bħal Dexamed huma aktar probabbli li jikkawżaw dipendenza minn kura oħra għal ADHD, abbażi ta' prattika klinika, ir-riskju ta' żvilupp ta' dipendenza f'pazjenti kkurati b'dexamfetamine huwa kkunsidrat baxx u jista' jiġi ġestit b'mod xieraq b'miżuri ta' tnaqqis tar-riskju adattati.
English: Why was Dexamed reviewed?
Maltese: Għaliex Dexamed ġie rivedut?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Dexamed outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following countries: Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain and Sweden.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) talAġenzija kkonkluda li l-benefiċċji ta' Dexamed jegħlbu r-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fir-Renju Unit u fil-pajjiżi li ġejjin: id-Danimarka, il-Finlandja, l-Irlanda, ilLussemburgu, il-Pajjiżi l-Baxxi, in-Norveġja, Spanja u l-Isvezja.
English: The CHMP also noted that evidence from studies and clinical practice is available to show that dexamfetamine is effective in ADHD, including in patients in whom other treatments have failed.
Maltese: Is-CHMP innota wkoll li evidenza minn studji u prattika klinika hija disponibbli biex turi li dexamfetamine huwa effettiv f'ADHD, inkluż f'pazjenti li fuqhom, kuri oħrajn ma rnexxewx.
English: Although the CHMP acknowledged that there is a risk of abuse and dependence with Dexamed, it concluded that the risk minimisation measures proposed to mitigate this risk are adequate.
Maltese: Għalkemm is-CHMP irrikonoxxa li hemm riskji ta' abbuż u dipendenza b'Dexamed, ikkonkluda li lmiżuri ta' tnaqqis tar-riskju proposti biex itaffu dan ir-riskju huma adegwati.
English: Educational material will also be given to pharmacists, parents and carers to help them identify any potential abuse or improper use of Dexamed.
Maltese: Sejjer jingħata wkoll materjal edukattiv lil spiżjara, ġenituri u carers biex jgħinom jidentifikaw xi abbuż jew użu żbaljat potenzjali ta' Dexamed.
English: Dexamfetamine belongs to a group of medicines called ‘psychostimulants' and is thought to work by activating certain areas of the brain that control attention and concentration, thus helping to reduce impulsive behaviour.
Maltese: Dexamfetamine jappartjeni għal grupp ta' mediċini li jissejħu ‘psikostimulanti' u huwa maħsub li jaħdem billi jattiva ċertu żoni tal-moħħ li jikkontrollaw l-attenzjoni u l-konċentrazzjoni, b'hekk jgħinu sabiex tonqos l-imġiba impulsiva.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 10 June 2013.
Maltese: Madankollu, l-Istati Membri ma kinux kapaċi jaslu għal ftehim u l-aġenzija regolatorja tal-mediċini tarRenju Unit irreferiet il-kwistjoni lis-CHMP għal arbitraġġ fl-10 ta' Ġunju 2013.
English: The grounds for the referral were concerns raised by the Netherlands that Dexamed presents a higher risk for abuse and dependence compared with other ADHD treatments, and that the data submitted to support the application did not provide sufficient evidence to demonstrate its effectiveness as a second-line treatment for ADHD.
Maltese: Ir-raġunijiet għar-riferiment kienu tħassib imqajjem mill-Pajjiżi l-Baxxi li Dexamed jippreżenta riskju ogħla ta' abbuż u dipendenza meta mqabbel ma' kuri oħrajn għall-ADHD, u li d-dejta ppreżentata biex tappoġġja l-applikazzjoni ma pprovdietx evidenza suffiċjenti biex turi l-effikaċja tiegħu bħala kura tattieni linja għal ADHD.
English: MA (EU) Number (Invented) name Strength
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Ghamla farmacewtika
English: Tablet coating Hypromellose Macrogol 400
Maltese: Hypromellose Macrogol 400
English: EU/1/02/218/011 500 ml (10 bottles of 50 ml)
Maltese: EU/1/02/218/011 500 ml (10 x 50 ml)
English: The most frequently occurring adverse reactions with a higher incidence in the Axura group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
Maltese: L-aktar reazzjonijiet avversi li seħħew ta' spiss fil-grupp ta' Axura milli fil-grupp tal-plaċebo kienu sturdament (6.3% vs 5.6%, rispettivament), uġigħ ta' ras (5.2% vs 3.9%), stitikezza (4.6% vs 2.6%), ngħas (3.4% vs 2.2%) u pressjoni għolja (4.1% vs 2.8%).
English: Mon → Tue → Wed → Thu → Fri → Sat → Sun
Maltese: X'għandek tkun taf qabel ma tieħu Axura
English: Date of first authorisation: 17 May 2002 Date of latest renewal: 17 May 2007
Maltese: Data ta' l-ewwel awtorizzazzjoni: 17 mejju 2002 Data ta' l-aħħar tiġdid: 17 mejju 2007
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets EU/1/02/218/016
Maltese: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita EU/1/02/218/016
English: Axura 10 mg tablets
Maltese: Axura 10 mg pilloli
English: Other medicines and Axura
Maltese: Mediċini oħra u Axura
English: Blister packs containing 14 film-coated tablets per PVDC/PE/PVC/Al-blister or PP/Al-blister strip.
Maltese: Pakketti b'folji li fihom 14-il pillola miksija b'rita għal PVDC/PE/PVC/Al jew folja strixxa ta' PP/Al.
English: EU/1/02/218/005 EU/1/02/218/006 EU/1/02/218/011
Maltese: EU/1/02/218/006 EU/1/02/218/011
English: EU/1/02/218/022 840 film-coated tablets (20 packs of 42) EU/1/02/218/029 840 film-coated tablets (20 packs of 42)
Maltese: EU/1/02/218/022 840 pilloli miksijin b'rita (20 x 42) EU/1/02/218/029 840 pilloli miksijin b'rita (20 x 42)
English: Axura 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Memantine hydrochloride
Maltese: Axura 5 mg, 10 mg, 15 mg, 20 mg pilloli miksija b'rita Memantine hydrochloride
English: Axura 5 mg, 10 mg, 15 mg, 20 mg tablets
Maltese: Axura pilloli ta' 5 mg, 10 mg, 15 mg, 20 mg
English: Axura 20 mg film-coated tablets EU/1/02/218/017
Maltese: Axura 20 mg pilloli miksijin b'rita EU/1/02/218/017
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Each pack contains 28 film-coated tablets in 4 PVDC/PE/PVC/Al-blister or PP/Al-blisters with 7 filmcoated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film-coated tablets of 20 mg.
Maltese: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita Kull pakkett fih 28 pillola miksija b'rita f'4 folji ta' PVDC/PE/PVC/Al jew folji ta' PP/Al għal 7 pilloli miksijin b'rita ta' 5 mg, 7 pilloli miksijin b'rita ta' 10 mg, 7 pilloli miksijin b'rita ta' 15 mg, 7 pilloli miksijin b'rita ta' 20 mg.
English: The other ingredients for Axura 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Axura 10 mg film-coated tablets is iron oxide yellow (E 172) and for Axura 15 mg and Axura 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Maltese: Is-sustanzi l-oħra f'Axura 5/10/15 u 20 mg microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, li lkoll jinsabu fil-qalba tal-pillola; u hypromellose, macrogol 400, titanium dioxide (E 171) u kif ukoll, iron oxide isfar (E 172) għall-pilloli miksijin b'rita ta' Axura 10 mg u iron oxide isfar u aħmar (E 172) għall-pilloli miksijin b'rita ta' Axura 15 mg u Axura 20 mg, li lkoll jinsabu fil-kisja tal-pilloli.
English: Axura contains the active substance memantine hydrochloride.
Maltese: Axurafih is-sustanza attiva memantine hydrochloride.
English: EU/1/02/218/010 1000 film-coated tablets (20 packs of 50) EU/1/02/218/015 980 film-coated tablets (10 packs of 98) EU/1/02/218/030 840 film-coated tablets (20 packs of 42)
Maltese: EU/1/02/218/015 980 pillola miksija b'rita (10 x 98) EU/1/02/218/030 840 pillola miksija b'rita (20 x 42)
English: Axura contains sorbitol
Maltese: Is-soluzzjoni orali fiha sorbitol.
English: Axura 10 mg film-coated tablets EU/1/02/218/001
Maltese: Axura 10 mg pilloli miksijin b'rita EU/1/02/218/001
English: Very rare (may affect up to 1 in 10,000 users): • Seizures
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna minn kull 10,000 utenti):
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Each filmcoated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Maltese: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 5 mg memantine hydrochloride ekwivalenti għal 4.15 mg memantine.
English: Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets and multipacks of 840 (20 packs of 42) tablets, 980 (10 packs of 98) tablets or 1000 (20 packs of 50) tablets.
Maltese: Il-pilloli Axura jiġu f'pakketti ta' folji b'14-il pillola, 28 pillola, 30 pillola, 42 pillola, 50 pillola, 56 pillola, 98 pillola, 100 pillola, 112 pillola.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web side: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Uncommon (may affect up to 1 in 100 users):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna minn kull 100 utenti):
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
Maltese: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita
English: Additional for 15 mg and 20 mg film-coated tablets: Iron oxide yellow and red (E 172)
Maltese: Sustanza addizzjonali għal pilloli miksijin b'rita ta' 15 mg u 20 mg: Iron oxide isfar u aħmar (E 172)
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Maltese: L-istudju wera effetti tajbin tal-kura b'memantine meta mqabbla ma' plaċebo mas-6 xahar (analiżi tal-każijiet għall-impressjoni ta' bidla skond intervista tat-tabib (CIBIC-plus): p=0.025; studju kooperattiv tal-marda Alzheimer (ADCS-ADLsev): p=0.003; Batterija ta' indeboliment sever (SIB): p=0.002).
English: One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Axura 5 mg, 7 tablets of Axura 10 mg, 7 tablets of Axura 15 mg and 7 tablets of Axura 20 mg.
Maltese: Pakkett wieħed li jintuża biex tinbeda l-kura fih 28 pillola f'4 folji b'7 pilloli ta' Axura 5 mg, 7 pilloli ta' Axura 10 mg, 7 pilloli ta' Axura 15 mg u 7 pilloli ta' Axura 20 mg.
English: Axura acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Maltese: Axura jaħdem fuq dawn ir-riċetturi-NMDA u it trasmissjoni tas-sinjali fin-nervituri u l-memorja.
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3-14) included a total of 252 outpatients.
Maltese: Studju pivitali b'terapija waħda f'popolazzjoni ta' pazjenti li kienu qed ibatu mill-marda ta' Alzheimer moderata għal severa (eżami żgħir ħafna ta' l-istat mentali (MMSE) punteġġ totali ta' MMSE fil-linja bażi ta' 3-14) kien jinkludi total ta' 252 outpatient .
English: EU/1/02/218/016 28 film-coated tablets EU/1/02/218/023 28 film-coated tablets
Maltese: EU/1/02/218/016 28 pilloli miksijin b'rita
English: Axura 20 mg film-coated tablets Memantine hydrochloride
Maltese: Axura 20 mg pilloli miksija b'rita Memantine hydrochloride
English: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg per day.
Maltese: F'pazjenti b'indeboliment renali moderat (rata ta' tneħħija tal kreatinina 30-49 ml/min) id-doża għandha tkun 10 mg kuljum.
English: Axura 5 mg/pump actuation, oral solution
Maltese: Axura 5 mg/għafsa soluzzjoni orali
English: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-kreatinina 30-49 ml/min) id-doża għandha tkun ta' 10 mg (1 ml ta' soluzzjoni, ekwivalenti għal żewġ għafsiet lisfel).
English: Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets Memantine hydrochloride
Maltese: Axura 5 mg pilloli miksijin b'rita Axura 10 mg pilloli miksijin b'rita Axura 15 mg pilloli miksijin b'rita Axura 20 mg pilloli miksijin b'rita Memantine hydrochloride
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5-1 µmol) with large interindividual variations.
Maltese: Dożi ta' 20 mg kuljum jwasslu għal konċentrazzjonijiet ta' memantine fil-plażma fi stat fiss f'medda ta' bejn 70 sa 150 ng/ml (0.5-1 µmol) b'varjazzjonijiet kbar bejn individwu.u ieħor.
English: Axura oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml).
Maltese: Is-soluzzjoni orali Axura, tiġi fi fliexken ta' 50 ml, 100 ml jew 10 x 50 ml.
English: • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) Very rare (may affect up to 1 in 10,000 users):
Maltese: • Uġigħ ta' ras, ngħas, stitkezza, testijiet tal-funzjoni tal-fwied għoljin, sturdament, disturbi tal bilanċ, qtugħ ta' nifs, pressjoni għolja tad-demm u sensittivita' eċċessiva għal-mediċini Mhux komuni (jistgħu jaffettwaw sa persuna minn kull 100 utenti):
English: Axura 5 mg/pump actuation, oral solution Memantine hydrochloride
Maltese: Axura 5 mg/għafsa soluzzjoni orali memantine hydrochloride
English: Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 56 tablets, 98 tablets or in multipacks of 840 (20 x 42) tablets.
Maltese: Il-pilloli miksijin b'rita ta' Axura jiġu f'pakketti ta' folji bi 14-il pillola, 28 pillola, 42 pillola, 56 pillola, 98 pillola.
English: Axura 10 mg film-coated tablets Memantine hydrochloride
Maltese: Axura 10 mg pilloli miksijin b'rita Memantine hydrochloride
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Maltese: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita Il-pilloli miksijin b'rita ta' 5 mg huma bojod għal offwajt, f'għamla ovali-oblong u miksijin b'rita b'intaljar ta' ‘5' fuq naħa waħda u intaljar ta' ‘MEM' fuq in-naħa l-oħra.
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Maltese: Fi provi kliniċi f'pazjenti b'dimenzja ħafifa għal severa, b'1,784 pazjent ikkurat b'Axura u 1,595 pazjent ikkurat bi plaċebo, ir-rata globali ta' reazzjonijiet avversi li seħħew b'Axura ma kienitx differenti min dik tal-plaċebo; ir-reazzjonijiet avversi ġeneralment kienu ħfief għal moderati fil-qawwa.
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Axura 20 mg film-coated tablets
Maltese: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita Axura 20 mg pilloli miksijin b'rita
English: Axura is not recommended for children and adolescents under the age of 18 years.
Maltese: Axura mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: Fatigue 1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
Maltese: 1 Alluċinazzjonijiet dehru l-aktar f'pazjenti bil-marda ta' Alzheimer severa.
English: The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Maltese: Axura jaħdem fuq dawn ir-riċetturi-NMDA u jtejjeb it-trasmissjoni tas-sinjali fin-nervituri u l-memorja.
English: Merz Pharma España S.L.
Maltese: Merz Pharma GmbH & Co.
English: Axura 20 mg tablets
Maltese: Axura pilloli ta' 20 mg
English: In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Maltese: F'każ ta' sinjali u sintomi ta' simulazzjoni eċċessiva tas-sistema nervuża ċentrali (SNĊ) ġenerali, għandha titqies kura klinika tas-sintomi bir-reqqa.
English: Axura 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Maltese: Il-pilloli miksijin b'rita ta' 15 mg huma oranġjo għal oranġjo griżi, pilloli miksijin b'rita li huma ovalioblong b'intaljar ta' ‘15' fuq naħa u ‘MEM' fuq naħa oħra.
English: How to store Axura
Maltese: X'fih Axura
English: Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets
Maltese: Axura 5 mg pilloli miksijin b'rita Axura 10 mg pilloli miksijin b'rita Axura 15 mg pilloli miksijin b'rita Axura 20 mg pilloli miksijin b'rita
English: In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
Maltese: F'pazjenti b'indeboliment sever renali (tneħħija tal-kreatinina 5-29 ml/min) id-doża għandha tkun 10 mg (1 ml ta' soluzzjoni,
English: Tel: +34 91 657 47 84
Maltese: Merz Pharma España S.L. Tel: +34 91 657 47 84
English: Axura 10 mg film-coated tablets Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: Axura 10 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 10 mg memantine hydrochloride ekwivalenti għal 8.31 mg memantine.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
Maltese: B'doża ta' 20 mg memantine kuljum il-livelli fil-fluwidu ċerebro-spinali (CSF) qablu mal-valur-ki (ki = kostanti ta' l-impediment) ta' memantine, li hija 0.5 µmol fil-kortiċi anterjuri al-bniedem.