FrancophonIA/ELRC3.0 huggingface dataset:
English: No information is available for events that occur at lower frequency, due to the size of the population studied; n=147 for first line treated patients and n=149 for previously treated patients.
Maltese: L-ebda informazzjoni ma hija disponibbli għal każijiet li jseħħu fi frekwenza aktar baxxa, minħabba d-daqs tal-popolazzjoni studjata; n=147 għal pazjenti kkurati l-ewwel darba u n=149 għal pazjenti kkurati qabel.
English: • fever, shivering/chills, sweating, nausea (feeling sick), vomiting, low blood pressure, low white/red blood cell levels, infections including pneumonia and blood poisoning, irritation and/or blistering of the mouth region, low blood platelet levels, tiredness, rash, itching, red raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.
Maltese: • deni, tertir/sirdat, għaraq, tqalligħ (tħossok ma tiflaħx), rimettar, pressjoni baxxa, għadd ta' ċelluli bojod/ħomor fid-demm baxx, infezzjonijiet inkluż pnewmonja u ivvalenar tad-demm, irritazzjoni u/jew infafet fil-ħalq u madwar, għadd ta' plejtlits fid-demm baxx, għeja, raxx, ħakk, leżjonijiet ħomor ibbuzzati fil-ġilda, qtugħ ta' nifs, uġigħ ta' ras, dijarea u nuqqas t'aptit.
English: Hypertension Vasospasm Flushing
Maltese: Uġigħ fis-sider Edima pulmonarja
English: MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.
Maltese: MabCampath huwa indikat għall-kura ta' pazjenti b'lewkimja limfoċitika kronika taċ-ċellula B (BCLL) li għalihom kimoterapija kombinata ta' fludarabine mhix xierqa.
English: A trend towards improved PFS was observed in patients with 17p deletion, trisomy 12 and normal karyotype, which did not reach significance due to small sample size.
Maltese: Xejra lejn PFS imtejjeb kienet osservata f'pazjenti bi tneħħija ta' 17q, trisomy 12 u karjotip normali, li ma laħqitx sinifikanza minħabba daqs ta' kampjun żgħir.
English: MabCampath is used to treat patients with chronic lymphocytic leukaemia (CLL), a cancer of the lymphocytes (a type of white blood cell).
Maltese: MabCampath jintuża għall-kura ta' pazjenti b'lewkimja limfoċitika kronika (CLL), kanċer tal-limfoċiti (tip ta' ċellula bajda tad-demm).
English: Pharmacokinetics were characterised in MabCampath-naive patients with B-cell chronic lymphocytic leukaemia (B-CLL) who had failed previous therapy with purine analogues.
Maltese: Il-farmakokinetika kienet ikkaratterizzata f'pazjenti li qatt ma ħadu MabCampath qabel li kellhom lewkimja limfoċita kronika taċ-ċellula B (B-CLL) li kienu rċevew terapija minn qabel b'analogi purini li ma ħadmitx.
English: CD4 and CD8 T-cell counts begin to rise from weeks 8-12 during treatment and continue to recover for several months following the discontinuation of treatment.
Maltese: L-għadd ta' ċelluli-T CD4 u CD8 jibda jogħla minn 8 ġimgħat sa 12-il ġimgħa waqt ilkura u jkompli jirkupra għal diversi xhur wara li titwaqqaf il-kura.
English: Males and females of childbearing capacity should use effective contraceptive measures during treatment and for 6 months following MabCampath therapy (see section 5.3).
Maltese: Irġiel u nisa li jista' jkollhom it-tfal għandhom jużaw miżuri effettivi ta' kontraċezzjoni waqt il-kura u sa sitt xhur wara t-terapija b'MabCampath (ara sezzjoni 5.3).
English: Fatigue Asthenia
Maltese: Disturbi vaskulari
English: The majority of these reactions are mild to moderate in severity.
Maltese: Il-maġġoranza ta' dawn irreazzjonijiet huma ta' severità ħafifa sa moderata.
English: Febrile neutropenia Pancytopenia Leukopenia Lymphopenia Purpura
Maltese: Disturbi bħal limfoma
English: Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the ampoule label.
Maltese: Tużax MabCampath wara d-data ta' skadenza (JIS) li tidher fuq il-kartuna ta' barra u t-tikketta ta' lampulla.
English: Palpitation Tachycardia
Maltese: Edima periorbitali
English: Hypertension
Maltese: Ipokalċimija
English: Pulmonary oedema Peripheral oedema Periorbital oedema Mucosal ulceration Infusion site bruising Infusion site dermatitis Infusion site pain
Maltese: Il-borża għandha tiġi maqluba bil-mod ta' taħt fuq sabiex titħallat is-soluzzjoni.
English: The following table outlines the recommended procedure for dose modification following the occurrence of haematological toxicity while on therapy:
Maltese: It-tabella li ġejja tiddeskrivi l-proċedura rrakkomandata għal modifikazzjoni tad-doża wara każ ta' tossiċità ematoloġika waqt it-terapija:
English: Safety data in first-line B-CLL patients are based on adverse reactions that occurred on study in 147 patients enrolled in a randomized, controlled study of MabCampath as a single agent administered at a dose of 30 mg intravenously three times weekly for up to 12 weeks, inclusive of dose escalation period.
Maltese: Tagħrif dwar is-sigurtà f'pazjenti b'B-CLL ikkurati l-ewwel darba huwa bbażat fuq reazzjonijiet avversi li seħħew waqt l-istudju b'147 pazjent rekrutati fi studju randomised, b'kontrolli, ta' MabCampath bħala s-sustanza unika mogħti f'doża ta' 30 mg ġol-vini tliet darbiet fil-ġimgħa sa 12-il ġimgħa, inkluż iż-żmien li d-doża titqawwa.
English: Lactation
Maltese: Ipoksja
English: - HIV.
Maltese: Għeja
English: In general, older patients (over 65 years of age) tolerate cytotoxic therapy less well than younger individuals.
Maltese: B'mod ġenerali, pazjenti anzjani (b'età `l fuq minn 65 sena) jittolleraw it-terapija ċitotossika ferm inqas minn individwi iżgħar.
English: MabCampath should be permanently discontinued if autoimmune anaemia or autoimmune thrombocytopenia appears.
Maltese: MabCampath għandu jitwaqqaf b'mod permanenti jekk titfaċċa anemija awtoimmuni jew tromboċitopenija awtoimmuni.
English: • dizziness, sensation of spinning, fainting, shaking or trembling movements, feeling restless
Maltese: • konfużjoni, ansjetà, depressjoni, nuqqas ta' rqad
English: Myocardial infarction and cardiac arrest have been observed in association with MabCampath infusion in this patient population.
Maltese: Infart mijokardijaku u arrest kardijaku ġew osservati f'assoċjazzjoni ma' infużjoni ta' MabCampath f'din il-popolazzjoni ta' pazjenti.
English: Serious side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, low red blood cell and low blood platelet levels, infections, bleeding in the brain (intracranial haemorrhage) have occurred with fatal outcome.
Maltese: Effetti sekondarji serji, inkluż diffikultà biex tieħu n-nifs, infjammazzjoni tal-pulmun, qtugħ ta' nifs estrem, ħass ħażin, attakk tal-qalb, livell baxx ta' ċelluli ħomor u ta' plejtlits fid-demm, infezzjonijiet, fsada fil-moħħ (emorraġija intrakranjali) seħħew b'konsegwenzi fatali.
English: It is recommended that MabCampath should be interrupted in patients whose platelet count falls to < 25,000/l or whose absolute neutrophil count (ANC) drops to < 250/l.
Maltese: Huwa rrakkomandat li MabCampath għandu jiġi interrott f'pazjenti li lgħadd tal-plejtlits tagħhom jinżel għal < 25,000/l jew li l-għadd assolut ta' newtrofili (ANC) jinżel għal < 250/l.
English: Hyperhidrosis Erythema
Maltese: Antibijotiċi profilattiċi
English: Clear Type I glass ampoule, containing 3 ml of concentrate.
Maltese: Ampulla ċara ta' ħġieġ ta' Tip I, li fiha 3 ml ta' konċentrat.
English: Metabolism and nutritional disorders: Tumour lysis syndrome with fatal outcome has been reported.
Maltese: Kienet irrapportata sindrome tad-disintegrazzjoni tat-tumur b'riżultat fatali.
English: • abnormal sensation/feeling or movement
Maltese: • sensazzjoni/tħossok mhux normali jew moviment mhux normali
English: Gastroenteritis Tongue ulceration Gingivitis Hiccup
Maltese: Rimettar emorraġija gastrointestinali
English: Myalgia Musculoskeletal pain
Maltese: Uġigħ muskoluskeltrali
English: In the randomized controlled trial in first line patients (Study 4), patients in the MabCampath arm were tested weekly for CMV using a PCR (polymerase chain reaction) assay from initiation through completion of therapy, and every 2 weeks for the first 2 months following therapy.
Maltese: Fil-prova randomised b'kontrolli f'pazjenti kkurati għall-ewwel darba (Studju 4), il-pazjenti fil-grupp ta' MabCampath kienu ttestjati kull ġimgħa għal CMV permezz ta' analiżi ta' PCR (polymerase chain reaction) mill-bidu sa tmiem it-terapija, u kull ġimagħtejn għall-ewwel xahrejn wara tmiem it-terapija.
English: Asthenia
Maltese: Infezzjoni
English: Hepatic function abnormal Bullous eruption Erythematous rash
Maltese: Dermatite allerġika Raxx bil-ħakk
English: Bacterial infection Viral infection Fungal dermatitis Laryngitis Rhinitis
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq Faringite
English: The potential for an increased risk of infection-related complications may exist following treatment with multiple chemotherapeutic or biological agents.
Maltese: Jista' jkun hemm potenzjal għal żieda fir-riskju ta' kumplikazzjonijiet assoċjati ma' infezzjoni wara lkura b'sustanzi multipli kimoterapewtiċi jew bijoloġiċi.
English: Very common
Maltese: Mixja mhux normali
English: Febrile neutropenia Neutropenia Leukopenia Thrombocytopenia Anaemia
Maltese: Limfoadenopatija Tromboċitopenija Epistassi Anemija
English: You may experience an allergic or hypersensitivity reaction to MabCampath solution, especially against the protein contained in it, while the infusion is given to you.
Maltese: Jista' jkollok esperjenza ta' reazzjoni allerġika jew ta' sensittività eċċessiva għas-soluzzjoni ta' MabCampath, speċjalment kontra l-proteina li tinsab fiha, waqt li tkun qed tingħata l-infużjoni.
English: There is no known specific antidote for MabCampath.
Maltese: M'hemm l-ebda antidotu speċifiku magħruf għal MabCampath.
English: • Keep this leaflet.
Maltese: • inti tqila (ara wkoll “Tqala”).
English: Rash pruritic Rash macular Rash erythematous Dermatitis
Maltese: JIS Aqra l-fuljett għaż-żmien li jdum tajjeb il-prodott rikostitwit
English: The secondary objectives included complete response (CR) and overall response (CR or partial response) rates using the 1996 NCIWG criteria, the duration of response, time to alternative treatment and safety of the two treatment arms.
Maltese: L-oġġettivi sekondarji kienu jinkludu rati ta' rispons sħiħ (CR) u rati ta' risponsi globali (CR jew rispons parzjali) bl-użu tal-kriterji NCIWG ta' l-1996, it-tul tar-rispons, iż-żmien sa kura alternattiva u s-sigurtà taż-żewg gruppi ta' kura.
English: Alemtuzumab causes the lysis of lymphocytes by binding to CD52, a highly expressed, nonmodulating antigen which is present on the surface of essentially all B and T cell lymphocytes as well as monocytes, thymocytes and macrophages.
Maltese: Ma kienet osservata l-ebda differenza evidenti fil-farmakokinetika bejn l-irġiel u n-nisa u lanqas ma ġie osservat xi effett evidenti minħabba l-età.
English: Medicinal product subject to restricted medical prescription (See Annex 1: Summary of Product
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK APPLIKABBLI
English: However, if acute moderate to severe adverse reactions such as hypotension, rigors, fever, shortness of breath, chills, rashes and bronchospasm (some of which may be due to cytokine release) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated before further dose escalation is attempted (see section 4.4).
Maltese: Madankollu, jekk iseħħu reazzjonijiet avversi akuti ta' natura moderata sa severa bħal pressjoni baxxa, tertir, deni, qtugħ ta' nifs, sirdat, raxx u bronkospażmu (li wħud minnhom jistgħu jkunu minħabba reħa ta' cytokine) fil-livell ta' dożaġġ ta' 3 mg jew ta' 10 mg, dawk id-dożi għandhom jiġu ripetuti kuljum sakemm ikunu ittollerati sew qabel ma tiġi ppruvata doża ogħla (ara sezzjoni 4.4).
English: Mucosal inflammation Infusion site erythema Localised oedema Infusion site oedema Malaise
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini: http://www.ema.europa.eu.
English: Withdrawal period
Maltese: Perijodu ta' Tiżmin
English: Target species
Maltese: Ippakkjar
English: 8501 Novo mesto SLOVENIA
Maltese: 8501 Novo mesto
English: Tmax is between 3 and 8 hours.
Maltese: tmax hija bejn 3 u 8 sigħat.
English: КРКА България ЕООД Teл.
Maltese: Представителство на КРКА България ЕООД Teл.:
English: BLISTER (PVC/PVDC-Alu FOIL)
Maltese: FOLJA (FOJL TAL-PVC/PVDC-Al)
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven GERMANY
Maltese: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven IL-ĠERMANJA
English: Date of first authorisation: 29 April 2013 Date of latest renewal: 18 January 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' April 2013 Data tal-aħħar tiġdid: 18 ta' Jannar 2018
English: Memantine has an absolute bioavailability of approximately 100 %.
Maltese: Memantine għandu bijodisponibilità assoluta ta' madwar 100%.
English: The most frequently occurring adverse reactions with a higher incidence in the memantine 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 każijiet reazzjonijiet avversi li seħħew ta' spiss fil-grupp ta' memantine 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: Blister (PVC/PVDC-Alu foil): 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets, in a carton box.
Maltese: Folja (fojl ta' PVC/PVDC-Al foil): 14, 28,30, 42, 50, 56, 60, 70, 84, 90, 98, 100 u 112-il pillola miksija b'rita, f'kaxxa tal-kartun.
English: See section 2 "Marixino contains lactose".
Maltese: Ara sezzjoni 2 " Marixino fih lactose".
English: Other medicines and Marixino
Maltese: Mediċini oħra u Marixino
English: Very Rare (may affect up to 1 in 10,000 people): - Seizures.
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna): - Aċċessjonijiet.
English: About 45 % of memantine is bound to plasma-proteins.
Maltese: Madwar 45% ta' memantine jeħel mal-proteini tal-plażma.
English: Paediatric population No data available.
Maltese: M'hemmx dejta disponibbli.
English: - Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels.
Maltese: - Sustanzi attivi oħra bħal cimetidine, ranitidine, procainamide, quinidine, quinine u nicotine li jużaw l-istess sistema ta' trasport ketajoniku renali bħal amantadine jistgħu ukoll jinteraġixxu ma' memantine u b'hekk jista' jkun hemm riskju ta' livelli ogħla fil-plażma.
English: Marixino contains lactose
Maltese: Marixino fih lactose
English: Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4- and 6-hydroxymemantine, and 1-nitroso-3,5-dimethyl-adamantane.
Maltese: Il-metaboli ewlenin fil-bniedem huma N-3,5-dimethylgludantan, it-taħlita ta' 4- u 6-hydroxy-memantine, u 1-nitroso-3,5-dimethyl-adamantane.
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Maltese: Studji f'voluntiera wrew farmakokinetika linejari f'medda ta' dożi minn 10 sa 40 mg.
English: Nervous System disorders
Maltese: Disturbi fis-sistema nervuża
English: Adverse reactions are ranked according to system organ class, using the following convention:very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma mniżżla skond il-klassi tas-sistema ta' l-organi, bil-konvenzjoni li ġejja: komuni ħafna (≥ 1/10) komuni (≥1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma jistgħax ikun stmat mit-tagħrif li hemm).
English: Tablet core: lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, talc (E553b), magnesium stearate (E470b).
Maltese: Il-qalba tal-pillola: lactose monohydrate, microcrystalline cellulose (E460), silika kollojdali anidra, talc (E553b), magnesium stearate (E470b).
English: Marixino contains the active substance memantine hydrochloride.
Maltese: Marixino fih is-sustanza attiva memantine hydrochloride.
English: C-memantine, a mean of 84 % of the dose was recovered within 20 days, more than 99 % being excreted renally.
Maltese: C-memantine mogħti b'mod orali, medja ta' 84% tad-doża kienet irkuprata fi żmien 20 jum, aktar minn 99% tneħħiet ma' l-awrina.
English: Marixino film-coated tablets are available in boxes of 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets in blisters.
Maltese: Il-pilloli miksija b'rita ta' Marixino jiġu f'kaxex ta' 14, 28,30, 42, 50, 56, 60, 70, 84, 90, 98, 100 u 112-il pillola miksija b'rita, f'folji.
English: Balance disorders
Maltese: Disturbi tal-bilanċ
English: In volunteers with normal kidney function, total clearance (Cltot) amounts to 170 ml/min/1.73 m2 and part of total renal clearance is achieved by tubular secretion.
Maltese: F'voluntiera b'funzjoni tal-kliewi normali, it-tneħħija totali (Cltot) kienet 170 ml/min/1.73 m2 u parti mit-tneħħija renali totali tinkiseb b'sekrezzjoni tubulari.
English: In particular, Marixino may change the effects of the following medicines and their dose may need to be adjusted by your doctor: - 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
Maltese: B'mod partikolari, Marixino jista' jibdel l-effetti tal-mediċini li ġejjin u d-doża tagħhom jista' jkollha bżonn tinbidel mit-tabib tiegħek: - amantadine, ketamine, dextromethorphan - dantrolene, baclofen - cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine - hydrochlorothiazide (jew kwalunkwe kombinazzjoni ma' hydrochlorothiazide) - antikolinerġiċi (sustanzi li ġeneralment jintużaw għall-kura ta' disturbi fil-movimenti jew spażmi fl-imsaren) - mediċini kontra l-aċċessjonijiet (mediċini li jintużaw biex ikunu evitati jew iserrħu l aċċessjonijiet) - barbiturati (sustanzi li ġeneralment jintużaw biex jgħinuk torqod) - agonisti dopaminerġiċi (sustanzi bħal L-dopa, bromocriptine) - newrolettiċi (sustanzi li jintużaw għall-kura ta' disturbi tal-moħħ) - mediċini orali kontra l-koagulazzjoni tad-demm
English: Marixino acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Maltese: Marixino jaġixxi fuq dawn ir-riċetturi-NMDA u jtejjeb it-trasmissjoni tas sinjali fin-nervituri u l-memorja.
English: Venous thrombosis/thromboembolism
Maltese: Trombożi fil-vini/tromboemboliżmu
English: Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous Talc (E553b)
Maltese: Lactose monohydrate Cellulose, microcrystalline (E460) Silica, anidru kollojdali
English: Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 10 mg memantine hydrochloride ekwivalenti għal 8.31 mg memantine.
English: CARTON BOX
Maltese: KAXXA TAL-KARTUN
English: When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated.
Maltese: Meta ngħataw dożi ta' 5 sa 30 mg kuljum, il-proporzjon tal-medja ta' fluwidu ċerebrospinali CSF/serum kien kalkolat 0.52.
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.
Maltese: 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: Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Maltese: Kull pillola miksija b'rita fiha 20 mg memantine hydrochloride Ekwivalenti għal 16.62 mg memantine.
English: Film coating: methacrylic acid-ethyl acrylate copolymer (1:1),sodium laurilsulfate, polysorbate 80, talc (E553b), triacetin, simeticone.
Maltese: Il-kisja tar-rita: methacrylic acid-ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, talc (E553b), triacetin, simeticone.
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 60 film-coated tablets 70 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Maltese: 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 60 pillola miksija b'rita 70 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita 112-il pillola miksija b'rita
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 l-intervista tat-tabib (CIBIC-plus): p=0.025; studju kooperattiv tal-marda ta' Alzheimer (ADCS-ADLsev): p=0.003; Batterija ta' indeboliment sever (SIB): p=0.002).
English: Treatment of adult patients with moderate to severe Alzheimer's disease.
Maltese: Kura ta' pazjenti adulti bil-marda ta' Alzheimer moderata għal severa.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: EU/1/13/820/014 14 film-coated tablets EU/1/13/820/015 28 film-coated tablets EU/1/13/820/016 30 film-coated tablets EU/1/13/820/017 42 film-coated tablets EU/1/13/820/018 50 film-coated tablets EU/1/13/820/019 56 film-coated tablets EU/1/13/820/020 60 film-coated tablets EU/1/13/820/021 70 film-coated tablets EU/1/13/820/022 84 film-coated tablets EU/1/13/820/023 90 film-coated tablets EU/1/13/820/024 98 film-coated tablets EU/1/13/820/025 100 film-coated tablets EU/1/13/820/026 112 film-coated tablets
Maltese: EU/1/13/820/014 14-il pillola miksija b'rita EU/1/13/820/015 28 pillola miksija b'rita EU/1/13/820/016 30 pillola miksija b'rita EU/1/13/820/017 42 pillola miksija b'rita EU/1/13/820/018 50 pillola miksija b'rita EU/1/13/820/019 56 pillola miksija b'rita EU/1/13/820/020 60 pillola miksija b'rita EU/1/13/820/021 70 pillola miksija b'rita EU/1/13/820/022 84 pillola miksija b'rita EU/1/13/820/023 90 pillola miksija b'rita EU/1/13/820/024 98 pillola miksija b'rita EU/1/13/820/025 100 pillola miksija b'rita EU/1/13/820/026 112-il pillola miksija b'rita