FrancophonIA/ELRC3.0 huggingface dataset:
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.
Dutch: 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: EU/1/02/218/017 14 film-coated tablets EU/1/02/218/018 28 film-coated tablets EU/1/02/218/019 42 film-coated tablets EU/1/02/218/020 56 film-coated tablets EU/1/02/218/021 98 film-coated tablets EU/1/02/218/024 14 film-coated tablets EU/1/02/218/025 28 film-coated tablets EU/1/02/218/026 42 film-coated tablets EU/1/02/218/027 56 film-coated tablets EU/1/02/218/028 98 film-coated tablets
Dutch: EU/1/02/218/017 14 pilloli miksijin b'rita EU/1/02/218/018 28 pilloli miksijin b'rita EU/1/02/218/019 42 pilloli miksijin b'rita EU/1/02/218/020 56 pilloli miksijin b'rita EU/1/02/218/021 98 pilloli miksijin b'rita EU/1/02/218/024 14 pilloli miksijin b'rita EU/1/02/218/025 28 pilloli miksijin b'rita EU/1/02/218/026 42 pilloli miksijin b'rita EU/1/02/218/027 56 pilloli miksijin b'rita EU/1/02/218/028 98 pilloli miksijin b'rita
English: Axura contains the active substance memantine hydrochloride.
Dutch: Axurafih is-sustanza attiva memantine hydrochloride.
English: Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Dutch: Xi fatturi li jistgħu jgħollu l-pH ta' l-awrina (ara sezzjoni 5.2 “Eliminazzjoni”) jistgħu jeħtieġu monitoraġġ bir-reqqa tal-pazjent.
English: A. LABELLING
Dutch: A. TIKKETTA
English: EU/1/02/218/016 28 film-coated tablets EU/1/02/218/023 28 film-coated tablets
Dutch: EU/1/02/218/016 28 pilloli miksijin b'rita EU/1/02/218/023 28 pilloli miksijin b'rita
English: The solution also contains potassium sorbate and sorbitol (E 420).
Dutch: Is-soluzzjoni fiha wkoll potassium sorbate u sorbitol (E 420).
English: Axura 10 mg film-coated tablets EU/1/02/218/001
Dutch: Axura 10 mg pilloli miksijin b'rita EU/1/02/218/001
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)
Dutch: EU/1/02/218/010 1000 pillola miksija b'rita (20 x 50) 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: Multipack 840 (20 packs of 42) film-coated tablets Multipack 980 (10 packs of 98) film-coated tablets Multipack 1000 (20 packs of 50) film-coated tablets
Dutch: Pakketti multipli ta' 840 (20 pakkett ta' 42) pillola miksija b'rita Pakketti multipli ta' 980 (10 pakkett ta' 98) pillola miksija b'rita Pakketti multipli ta' 1000 (20 pakkett ta' 50) pillola miksija b'rita
English: The same may be true for ketamine and dextromethorphan (see also section 4.4).
Dutch: Dan jista' jgħodd ukoll għal ketamine u dextromethorphan (ara wkoll sezzjoni 4.4).
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Dutch: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: ANNEX II
Dutch: ANNESS II
English: - amantadine, ketamine, dextromethorphan - dantrolene, baclofen - cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine - hydrochlorothiazide (or any combination with hydrochlorothiazide) - anticholinergics (substances generally used to treat movement disorders or intestinal cramps) - anticonvulsants (substances used to prevent and relieve seizures) - barbiturates (substances generally used to induce sleep) - dopaminergic agonists (substances such as L-dopa, bromocriptine) - neuroleptics (substances used in the treatment of mental disorders) - oral anticoagulants
Dutch: - amantadine, ketamine, dextromethorphan - dantrolene, baclofen - cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine - hydrochlorothiazide (jew kwalunkwe kombinazzjoni ma' hydrochlorothiazide)
English: OTHER
Dutch: JIS
English: Common
Dutch: Komuni
English: EU/1/02/218/012 14 film-coated tablets EU/1/02/218/007 28 film-coated tablets EU/1/02/218/001 30 film-coated tablets EU/1/02/218/013 42 film-coated tablets EU/1/02/218/002 50 film-coated tablets EU/1/02/218/008 56 film-coated tablets EU/1/02/218/014 98 film-coated tablets EU/1/02/218/003 100 film-coated tablets EU/1/02/218/009 112 film-coated tablets
Dutch: EU/1/02/218/012 14-il pillola miksija b'rita EU/1/02/218/007 28 pillola miksija b'rita EU/1/02/218/001 30 pillola miksija b'rita EU/1/02/218/013 42 pillola miksija b'rita EU/1/02/218/002 50 pillola miksija b'rita EU/1/02/218/008 56 pillola miksija b'rita EU/1/02/218/014 98 pillola miksija b'rita EU/1/02/218/003 100 pillola miksija b'rita EU/1/02/218/009 112-il pillola miksija b'rita
English: The patient had received 400 mg memantine orally.
Dutch: Il-pazjent kien irċieva 400 mg memantine b'mod orali.
English: Venous thrombosis/thromboembolism
Dutch: Trombożi fil-vini/trombo emboliżmu
English: Multipack 840 (20 packs of 42) film-coated tablets
Dutch: Pakketti multipli ta' 840 (20 pakketti ta' 42) pillola miksija b'rita
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Dutch: Analiżi-meta ta' pazjenti bil-marda ta' Alzheimer moderata għal severa (total tal-punteġġi MMSE < 20) minn sitt studji ta' fażi III kontrollati bi plaċebo li damu 6-xhur (inklużi studji b'monoterapija u studji b'pazjenti fuq doża stabbli ta' inibituri ta' acetylcholinesterase) wriet li kien hemm effett statistikament sinifikanti favur il-kura b'memantine fil-qasam ta' l-għarfien, globali u funzjonali.
English: Hepatic impairment
Dutch: Indeboliment epatiku
English: Reporting of suspected adverse reactions
Dutch: Rappurtar ta' reazzjonijiet avversi suspettati
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.
Dutch: 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: Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins.
Dutch: Proċess renali ieħor jinvolvi ri-assorbiment tubulari, probabbli permezz ta' proteini ta' trasport katajoniċi.
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects no relevant active substance-active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Dutch: Fi studji farmakokinetiċi b'doża waħda (PK) f'żgħażagħ b'saħħithom, ma dehrietx interazzjoni bejn sustanza attiva u oħra ta'memantine ma' glyburide/metformin jew donepezil.
English: You may experience increased symptoms as described in section 4.
Dutch: Jista' jkollok aktar sintomi li hemm imsemmija f'sezzjoni 4.
English: Maintenance dose The recommended maintenance dose is 20 mg per day.
Dutch: Doża ta' manteniment Id-doża ta' manteniment rakkomandata hi ta' 20 mg kuljum.
English: Psychiatric disorders
Dutch: Disturbi psikjatriċi
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.
Dutch: 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: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Dutch: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 42 pillola miksija b'rita 50 pillola miksija b'rita 56 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita 112-il pillola miksija b'rita
English: Both compounds are chemically related NMDA-antagonists.
Dutch: Iż-żewġ sustanzi huma antagonsiti-NMDA kimikament relatati.
English: When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated.
Dutch: Meta ngħataw dożi ta' 5 sa 30 mg kuljum, il-proporzjon tal-medja ta' fluwidu ċerebrospinali (CSF)/serum kien kalkolat 0.52.
English: The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (1 pump actuation is equivalent to 0.5 ml oral solution, and contains 5 mg of the active substance memantine hydrochloride; fig. 6).
Dutch: Meta ras il-pompa terġa' tingħafas l-isfel kompletament(ekwivalenti għal għafsa waħda tal-pompa), toħroġ id-doża korretta (għafsa waħda hija ekwivalenti għal 0.5 ml ta' soluzzjoni orali, u fiha madwar 5 mg tas-sustanza attiva memantine hydrochloride; fig. 6).
English: In a clinical study in young healthy subjects no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Dutch: Fi studju kliniku ma dehrx effett rilevanti ta' memantine fuq il-farmakokinetika ta' galantamine.
English: There is a possible relationship between this accumulation and the vacuolisation observed in lungs.
Dutch: Hemm relazzjoni possibbli bejn din l-akkumulazzjoni u l-vakwolizzazzjoni osservata fil-pulmun.
English: Fungal infections
Dutch: Infezzjonijiet u infestazzjonijiet
English: Balance disorder
Dutch: Komuni disturbi tal-bilanċ
English: Multipack 500 ml, comprising 10 packs, each containing 1 bottle with 50 ml oral solution.
Dutch: GĦAMLA FARMAĊEWTIKA U KONTENUT Pakketti multipli ta' 500 ml, li jinkludu 10 pakketti, kull wieħed fih flixkun b'50 ml soluzzjoni orali.
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20 days, more than 99% being excreted renally.
Dutch: Fi studju b'14C-memantine mogħti b'mod orali, medja ta' 84% tad-doża kienet irkuprata fi żmien 20 jum, aktar minn 99% tneħħiet ma' l-awrina.
English: The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow and red (E 172), all in the tablet coating.
Dutch: Is-sustanzi l-oħra huma microcrystalline cellulose, colloidal anhydrous silica, talc u magnesium stearate, kollha fil-qalbha tal-pillola; u hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow u red (E 172), kollha fil-kisja tal-pillola.
English: The potential risk for humans is unknown.
Dutch: Ir-riskju li jista' jkun hemm fuq in-nies, mhux magħruf.
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
Dutch: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita
English: 5 mg tablet week 2
Dutch: pillola ta' 5 mg ġimgħa 2
English: Additional for 15 mg and 20 mg film-coated tablets: Iron oxide yellow and red (E 172)
Dutch: Sustanza addizzjonali għal pilloli miksijin b'rita ta' 15 mg u 20 mg: Iron oxide isfar u aħmar (E 172)
English: Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist.
Dutch: Memantine huwa anatagonist mhux kompetittiv b'affinità moderata għar-riċettur-NMDA li jiddipendi mill-vultaġġ.
English: In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
Dutch: Fi studju ieħor b'terapija waħda għal marda ta' Alzheimer ħafifa għal moderata, total ta' 470 pazjent (punteġġi totali MMSE mal-linja bażi ta' 11-23) kienu randomizzat.
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).
Dutch: 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: For detailed instructions on the preparation and handling of the product see section 6.6.
Dutch: Għal istruzzjonijiet dettaljati dwar il-preparazzjoni u l-immaniġġjar tal-prodott ara sezzjoni 6.6.
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.
Dutch: 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: • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Dutch: • L-użu ta' memantine u amantadine għandu jkun evitat, minħabba r-riskju ta' psikożi farmakotossika.
English: In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg per day.
Dutch: F'pazjenti b'indeboliment sever renali (rata ta' tneħħija tal-kreatinina 5-29 ml/min) id-doża ta' kuljum għandha tkun 10 mg kuljum.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Dutch: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: The other ingredients are: potassium sorbate, sorbitol (E 420) and purified water.
Dutch: Is-sustanzi l-oħra huma: potassium sorbate, sorbitol (E 420) u ilma purifikat.
English: In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Dutch: Fil-parti l-kbira tal-provi kliniċi, pazjenti li ftit qabel kellhom infart mijokardijaku, insuffiċjenza mhux kompensata tal-qalb konġestiva (NYHA III-IV), jew pressjoni għolja mhux kontrollata kienu esklużi.
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Dutch: Skala ta' assessjar tal-marda Alzheimer ADAS-cog (p=0.003) u CIBIC-plus (p=0.004) f'Ġimgħa 24
English: Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Dutch: Kull pillola miksija b'rita fiha 15 mg memantine hydrochloride ekwivalenti għal 12.46 mg memantine.
English: Excipients: The oral solution contains sorbitol.
Dutch: Sustanzi mhux attivi: Is-soluzzjoni orali fiha sorbitol.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (20 x 42 TABLETS, 20 x 50 TABLETS AND 10 x 98 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX)
Dutch: TIKKETTA TAT-TGEŻWIR TA' BARRA FUQ IL-MULTIPAKKS (20 x 42 PILLOLA, 20 x 50 PILLOLA U 10 x 98 PILLOLA) IMGEŻWRA FIL-FOJL (LI JINKLUDI L-KAXXA BLU)
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.
Dutch: 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: Dosage
Dutch: Rimettar
English: • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Dutch: • Għeja, infezzjonijiet tal-moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali,
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
Dutch: 14-il pillola miksija b'rita 28 pillola miksija b'rita 42 pillola miksija b'rita 56 pillola miksija b'rita 98 pillola miksija b'rita
English: Lot {number} See embossed stamp.
Dutch: Jista' jkun li mhux il-pakketti kollha jkunu għal skop kummerċjali.
English: Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Dutch: Kull pillola miksija b'rita fiha 5 mg memantine hydrochloride ekwivalenti għal 4.15 mg memantine.
English: Headache
Dutch: Dożaġġ
English: Axura 20 mg film-coated tablets Memantine hydrochloride
Dutch: Axura 20 mg pilloli miksija b'rita Memantine hydrochloride
English: Vascular disorders
Dutch: Disturbi vaskulari
English: PHARMACEUTICAL FORM AND CONTENTS
Dutch: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: BATCH NUMBER
Dutch: NUMRU TAL-LOTT
English: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg per day.
Dutch: F'pazjenti b'indeboliment renali moderat (rata ta' tneħħija tal kreatinina 30-49 ml/min) id-doża għandha tkun 10 mg kuljum.
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).
Dutch: 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
Dutch: 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.
Dutch: 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: 15 mg tablet week 4 and beyond
Dutch: pillola ta' 15 mg minn ġimgħa 4
English: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dose adjustment is needed.
Dutch: F'pazjenti b'indeboliment epatiku ħafif għal moderat (Child-Pugh A u Child-Pugh B) m'hemmx bżonn ta' tibdil fid-doża.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Dutch: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: In man, about 80% of the circulating memantine-related material is present as the parent compound.
Dutch: Fil-bniedem, madwar 80% tal-materjal li għandu x'jaqsam ma' memantine li jkun fiċ-ċirkolazzjoni jinsab bħala s-sustanza mhux mibdula.
English: Axura oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml).
Dutch: Is-soluzzjoni orali Axura, tiġi fi fliexken ta' 50 ml, 100 ml jew 10 x 50 ml.
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.
Dutch: 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: Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
Dutch: Minbarra hekk, il-pH ta' l-awrina tista' titla minħabba każijiet ta' aċidożi tubulari renali (RTA) jew infezzjonijiet severi tal-passaġġ awrinarju b'Proteus bacteria.
English: No genotoxicity has been observed following testing of memantine in standard assays.
Dutch: Ma ġiet osservata l-ebda tossiċità għal ġeni wara testijiet b'memantine f'assaġġi standard.
English: Axura 10 mg film-coated tablets Memantine hydrochloride
Dutch: 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.
Dutch: 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.
Dutch: 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: Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Dutch: Kull pillola miksija b'rita fiha 20 mg memantine hydrochloride li hi ekwivalenti għal 16.62 mg memantine.
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Axura 20 mg film-coated tablets
Dutch: 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.
Dutch: Axura mhux rakkomandat fit-tfal u adolexxenti taħt it-18-il sena.
English: 1 g of solution contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Dutch: GĦAMLA KWALITATTIVA U KWANTITATTIVA 1 g tas-soluzzjoni fiha 10 mg memantine hydrochloride ekwivalenti għal 8.31 mg memantine.
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):
Dutch: • 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: Week 2 (day 8-14): Take one 10 mg tablet once a day (pale yellow to yellow, oval shaped) for 7 days.
Dutch: Ġimgħa 2 (jum 8-14): Ħu pillola miksija b'rita waħda ta' 10 mg kuljum (safra ċara għal safra, b'forma ovali) għal 7 t'ijiem.
English: Axura 5 mg/pump actuation, oral solution Memantine hydrochloride
Dutch: Axura 5 mg/għafsa soluzzjoni orali memantine hydrochloride
English: Manufacturer
Dutch: Manifattur
English: Pancreatitis2
Dutch: Tittrazzjoni tad-doża
English: Seizures
Dutch: Pożoloġija
English: „Possible side effects“.
Dutch: “Effetti sekondarji li jista' jkollu”.