FrancophonIA/ELRC3.0 huggingface dataset:
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U L-MANIFATTUR RESPONSABBLI
English: Box of 50 vials of 1 dose.
Maltese: Kaxxa ta' 50 kunjett ta' doża waħda.
English: SPECIAL WARNING(S)
Maltese: NUMRU(I)
English: After inoculation, the virus expresses the protective protein, but does not replicate in the cat.
Maltese: Wara t-tilqima, il-virus jesprimi l-proteina protettiva, iżda ma jirreplikax ruħu fil-qattus.
English: Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
Maltese: Immunizzazzjoni attiva ta' qtates ta' 12-il ġimgħa u ikbar biex tipprevjeni mwiet kawżati minn linfezzjoni tar-rabies.
English: No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been observed after the administration of 10 doses.
Maltese: L-ebda effetti mhux mixtieqa ħlief dawk imsemmija fis-sezzjoni "Effetti mhux mixtieqa" ma ġew osservati meta ġiet amministrata doża eċċessiva ta' 10 darbiet id-doża.
English: Vaccine against rabies infection.
Maltese: Vaċċin kontra l-infezzjoni tar-Rabies.
English: Box of 10 vials of 1 dose.
Maltese: Kaxxa ta' 10 kunjett ta' doża waħda.
English: Canarypox recombinants are known to be safe for humans.
Maltese: Huwa magħruf li r-rikombinati tal-Canarypox huma siguri għall-bnedmin.
English: Onset of immunity: 4 weeks after the primary vaccination course.
Maltese: Bidu tal-immunità: 4 ġimgħat wara l-ewwel kors ta' vaċċinazzjoni.
English: EXP (month/year)
Maltese: FAID*50
English: Read the package leaflet before use
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq
English: Efficacy data are available which demonstrate that this vaccine can be administered at least 14 days before or after the administration of MERIAL non-adjuvanted vaccine against feline leukaemia.
Maltese: Hemm informazzjoni dwar l-effikaċja li turi li din it-tilqima tista' tiġi amministrata mill-inqas 14-il jum qabel jew wara l-amministrazzjoni ta' tilqim tal-Merial mingħajr aġġuvant kontra l-lukimja filqtates.
English: Pharmacotherapeutic group: Other immunologicals for cats.
Maltese: Ladarba jinfetaħ uża immedjatament.
English: Duration of immunity after primary vaccination: 1 year.
Maltese: Tul ta' immunità wara l-ewwel vaċċinazzjoni: sena.
English: As a consequence, the vaccine stimulates active immunity against rabies virus in cats.
Maltese: B'konsegwenza , il-vaċċin jistimola immunità attiva kontra l-virus tarrabies fil-qtates.
English: Manufacturer responsible for batch release: MERIAL
Maltese: Prodott mediċinali veterinarju mgħoti bir-riċetta
English: Disposal: Read package leaflet.
Maltese: Aqra fuljett ta' tagħrif fil-pakkett.
English: Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap.
Maltese: Kunjett tal-ħġieġ ta' Tip I b'tapp tal-butyl elastomer u ssiġillat b'tapp tal-aluminju.
English: Box of 2 or 10 or 50 vials of 1 dose.
Maltese: Pakkett li għandu 2 jew 10 jew 50 kunjett ta' doża waħda.
English: Do not mix with any other veterinary medicinal product, except those mentioned in section 4.8.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor ħlief dawk imsemmija fis-sezzjoni 4.8.
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: Għal trattament tal-annimali biss - Għandu jingħata biss b'riċċetta veterinarja.
English: Administer one dose of 1 ml according to the following vaccination scheme: Primary vaccination course: 1 injection from 12 weeks of age, Revaccination: 1 year after primary vaccination, then at intervals of up to 3 years.
Maltese: Ripetizzjoni tal-vaċċin: sena wara l-ewwel vaċċinazzjoni, u mbagħad f'intervalli ta' mhux aktar minn 3 snin.
English: Travel to countries requiring a rabies serology test: experience has shown that some vaccinated animals, while protected, may not show the 0.5 IU/ml antibody titre required by some countries.
Maltese: Is-sigurtà tal-prodott veterinarju mediċinali ma ġietx stabbilita waqt it-tqala u t-treddigħ Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni:
English: The reactions may last longer.
Maltese: L-effetti jistgħu jdumu iżjed.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U L-MANIFATTUR
English: Concentrate: 2 ml Solvent: 100 ml
Maltese: 2 ml Solvent: 100 ml
English: Pancreatitis2
Maltese: Pankrejatite2
English: Macrogol 8000 (E1521)
Maltese: Macrogol 400 (E1521) Macrogol 8000 (E1521)
English: Generics [UK] Limited Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom.
Maltese: Generics [UK] Limited Station Close, Potters Bar, Hertfordshire EN6 1TL, Ir-Renju Unit.
English: Date of latest renewal: 08 January 2018
Maltese: Data tal-aħħar tiġdid: 08 ta' Jannar 2018
English: McDermott Laboratories Ltd. T/A Gerard Laboratories Unit 35 Baldoyle Industrial Estate Grange Road
Maltese: T/A Gerard Laboratories Unit 35 Baldoyle Industrial Estate Grange Road
English: McDermott Laboratories Ltd. T/A Gerard Laboratories Unit 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Maltese: T/A Gerard Laboratories Unit 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, L-Irlanda.
English: Paediatric population No data available.
Maltese: Popolazzjoni pedjatrika Dejta mhux disponibbli.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' April, 2013
English: Psychotic reactions2
Maltese: Reazzjonijiet psikotiċi2
English: 1, Hungary.
Maltese: 1, L-Ungerija.
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: 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 kklassifikati skont is-sistema tal-klassifika tal-organi bl-użu talkonvenzjoni 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 tistax tittieħed stima mid-data disponibbli).
English: Tablet cores for 10/20 mg film-coated tablets: Cellulose, microcrystalline Croscarmellose sodium Magnesium stearate
Maltese: Qlub tal-pilloli għal 10/20 mg pilloli miksijin b'rita: Cellulose microcrystalline Croscarmellose sodium
English: Memantine Mylan film-coated tablets are available in blister packs of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.
Maltese: Memantine Mylan pilloli miksija b'rita huma disponibbli f'pakketti bil-folji ta' 7, 10, 14, 28, 28 × 1, 30, 42, 50, 56, 56 × 1, 60, 70, 84, 98, 98 × 1, 100, 100 × 1 jew 112-il pillola miksija b'rita.
English: Hypromellose 3cP (E464)
Maltese: Hypromellose 3cP (E464) Hypromellose 6cP (E464) Hypromellose 50cP (E464)
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and colloidal anyhdrous silica, all in the tablet core; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide red (E172), macrogol 400 (E1521), macrogol 8000, all in the tablet coating.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc u colloidal anyhdrous silica, kollha fil-qalba tal-pillola; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide red (E172), macrogol 400 (E1521), macrogol 8000, kollha fil-kisja tal-pillola.
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc and colloidal anyhdrous silica, all in the tablet core; polydextrose (E1200), titanium dioxide (E171), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide yellow (E172), macrogol 400 (E1521), macrogol 8000, indigo carmine aluminium lake (E132) and iron oxide red (E172), all in the tablet coating.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc u colloidal anyhdrous silica, kollha fil-qalba tal-pillola; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide isfar (E172), macrogol 400 (E1521), macrogol 8000, indigo carmine aluminium lake (E132), iron oxide red (E172), kollha fil-kisja tal-pillola.
English: OTHER Mon → Tue → Wed → Thu → Fri → Sat → Sun
Maltese: M'għandekx tgħaddiha lil persuni oħra.
English: Memantine Mylan contains the active substance memantine.
Maltese: Memantine Mylan fih is-sustanza attiva memantine.
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: Clear PVC-PVdC film with push through aluminium foil lidding blisters in pack sizes of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.
Maltese: Rita ċara tal-PVC-PVdC b'folji b'lidding foil tal-aluminju li tista' timbuttah f'daqsijiet tal-pakketti ta' 7, 10, 14, 28, 28 × 1, 30, 42, 50, 56, 56 × 1, 60, 70, 84, 98, 98 × 1, 100, 100 × 1 jew 112-pillola miksija b'rita.
English: • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Maltese: • Għeja, infezzjonijiet tal-moffa, konfużjoni, alluċinazzjonijiet, rimettar, mixja anormali, Insufiċjenza kardijaka u trombożi/tromboemboliżmu
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: What Memantine Mylan contains - The active substance is memantine.
Maltese: X'fih Memantine Mylan - Is-sustanza attiva hi memantine.
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.
Maltese: 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: 98 x 1 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets 112 film-coated tablets
Maltese: 98 × 1 pillola miksija b'rita 100 pillola miksija b'rita 100 × 1 pillola miksija b'rita 112-il pillola miksija b'rita
English: Venous thrombosis/thromboembolism
Maltese: Trombożi fil-vini/trombo- emboliżmu
English: In particular, Memantine Mylan 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: - 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: The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in clear PVC-PVdC film with push through aluminium foil lidding perforated unit dose blisters.
Maltese: Id-daqsijiet tal-pakketti ta' 28 × 1, 56 × 1, 98 × 1 u 100 × 1 pillola miksija b'rita huma ppreżentati f'rita ċara tal-PVC-PVdC b'folji tad-doża tal-unità b'lidding foil tal-aluminju li tista' timbuttah perforati.
English: Mylan Hungary Kft. H-2900 Komárom, Mylan utca.
Maltese: Komárom, Mylan utca.
English: Pharmacotherapeutic group: Psychoanaleptics, other anti-dementia drugs, ATC code: N06DX01.
Maltese: Kategorija farmakoterapewtika: Psikoalattetiċi, mediċini oħrajn kontra d-dimenzja, Kodiċi ATC:
English: This leaflet was last revised in {month YYYY}.
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Tel: + 39 02 612 46921
Maltese: Mylan S.p.A Tel: + 39 02 612 46921
English: 117 Allée des Parcs, 69800 Saint-Priest, France.
Maltese: Mylan S.A.S. 117 Allée des Parcs, 69800
English: Linearity Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Maltese: Linearità Studji f'voluntiera wrew farmakokinetika linejari f'medda ta' dożi minn 10 sa 40 mg.
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)).
Maltese: Skala ta' assessjar tal-marda ta' Alzheimer ADAS-cog (p=0.003) u CIBIC-plus (p=0.004) f'Ġimgħa 24 bl-aħħar osservazzjoni miġjuba 'l quddiem (LOCF).
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: EU/1/13/827/001 EU/1/13/827/002 EU/1/13/827/003 EU/1/13/827/004 EU/1/13/827/005 EU/1/13/827/006 EU/1/13/827/007
Maltese: EU/1/13/827/001 EU/1/13/827/002 EU/1/13/827/003 EU/1/13/827/004
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Maltese: Fil-każijiet ta' doża eċċessiva taħt il-140 mg jew doża mhux magħrufa il-pazjenti wrew sintomi li kienu ġejjin mis- sistema nervuża ċentrali (konfużjoni, tħeddil, ngħas, vertiġini, aġitazzjoni, imġieba aggressiva, alluċinazzjoni, u disturbi fil-qagħda tal-mixi) u/jew ta' natura gastro-intestinali (rimettar u dijarea).
English: The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blisters.
Maltese: Id-daqsijiet tal-pakketti ta' 28 × 1, 56 × 1, 98 × 1 u 100 × 1 pillola miksija b'rita huma ppreżentati f'folji tad-doża tal-unità.
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.
Maltese: 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 randomizzati.
English: Mylan Hungary Kft. H-2900 Komárom Mylan utca.
Maltese: Komárom Mylan utca.
English: INFORMATION IN BRAILLE Memantine Mylan 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Memantine Mylan pilloli ta' 20 mg
English: INFORMATION IN BRAILLE Memantine Mylan 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Memantine Mylan pilloli ta' 10 mg
English: How to store Memantine Mylan
Maltese: Mediċini oħra u Memantine Mylan
English: V.J.
Maltese: U L- UŻU
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine 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 moderata, b'1,784 pazjent ikkurat b'memantine Mylan u 1,595 pazjent ikkurat bi plaċebo, ir-rata globali ta' reazzjonijiet avversi li seħħew b'memantine ma kinitx differenti min dik tal-plaċebo; ir-reazzjoniiet avversi ġeneralment kienu ħfief għal moderati fil-qawwa.
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.
Maltese: Ir-rekwiżiti għall-preżentazzjoni ta' rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux Komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna):
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 fil- linja bażi ta' 3-14) kien jinkludi 252 outpatient.
English: EU/1/13/827/032 98 film-coated tablets
Maltese: EU/1/13/827/032 98 pillola miksija b'rita.
English: The use of medicinal products called amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Maltese: L-użu ta' prodotti mediċinali msejjħa amantadine (għat-trattament tal-marda ta' Parkinson), ketamine (sustanza li ġeneralment tingħata bħala loppju), dextromethorphan (ġeneralment użat biex jikkura ssogħla) u antagonisti oħra ta' NMDA fl-istess ħin għandu jkun evitat.
English: Each film-coated tablet contains 20 mg of 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: Very rare (may affect up to 1 in 10,000 people): • Seizures
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna):
English: EU/1/13/827/033 98 x 1 film-coated tablets EU/1/13/827/034 100 film-coated tablets EU/1/13/827/035 100 x 1 film-coated tablets EU/1/13/827/036 112 film-coated tablets
Maltese: EU/1/13/827/033 98 × 1 pillola miksija b'rita EU/1/13/827/034 100 pillola miksija b'rita EU/1/13/827/035 100 × 1 pillola miksija b'rita EU/1/13/827/036 112-il pillola miksija b'rita
English: From the fourth week on, the usual dose is one 20 mg tablet once a day (20 mg).
Maltese: Mir-raba' ġimgħa 'l hemm, id-doża normali hi ta' pillola waħda ta' 20 mg darba kuljum (20 mg).
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola miksija b'rita fiha 20 mg ta' memantine hydrochloride ekwivalenti għal 16.62 mg memantine.
English: Dosage
Maltese: Rimettar
English: Indigo carmine aluminium lake (E132)
Maltese: Bħala żieda mal-pilloli miksijin b'rita ta' 10 mg: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
English: MARKETING AUTHORISATION HOLDER Mylan S.A.S.
Maltese: FIS-SUQ Mylan S.A.S.
English: EU/1/13/827/014 98 film-coated tablets
Maltese: EU/1/13/827/014 98 pillola miksija b'rita.
English: EU/1/13/827/015 98 x 1 film-coated tablets EU/1/13/827/016 100 film-coated tablets EU/1/13/827/017 100 x 1 film-coated tablets EU/1/13/827/018 112 film-coated tablets
Maltese: EU/1/13/827/015 98 × 1 pillola miksija b'rita EU/1/13/827/016 100 pillola miksija b'rita EU/1/13/827/017 100 × 1 pillola miksija b'rita EU/1/13/827/018 112-il pillola miksija b'rita
English: EU/1/13/827/008 EU/1/13/827/009 EU/1/13/827/010 EU/1/13/827/011 EU/1/13/827/012 EU/1/13/827/013 EU/1/13/827/014 EU/1/13/827/015 EU/1/13/827/016 EU/1/13/827/017 EU/1/13/827/018 EU/1/13/827/019 EU/1/13/827/020 EU/1/13/827/021 EU/1/13/827/022 EU/1/13/827/023 EU/1/13/827/024 EU/1/13/827/025 EU/1/13/827/026 EU/1/13/827/027 EU/1/13/827/028 EU/1/13/827/029 EU/1/13/827/030 EU/1/13/827/031 EU/1/13/827/032 EU/1/13/827/033 EU/1/13/827/034 EU/1/13/827/035 EU/1/13/827/036
Maltese: EU/1/13/827/025 EU/1/13/827/026 EU/1/13/827/027 EU/1/13/827/028 EU/1/13/827/029 EU/1/13/827/030 EU/1/13/827/031 EU/1/13/827/032 EU/1/13/827/033 EU/1/13/827/034
English: Each film-coated tablet contains 10 mg of 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: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Maltese: • Uġigħ ta' ras, ngħas, stitkezza, testijiet tal-funzjoni tal-fwied għoljin, sturdament, disturbi talbilanċ, qtugħ ta' nifs, pressjoni għolja tad-demm u sensittivita' eċċessiva għal-mediċini
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola miksija b'rita fiha 10 mg ta' memantine hydrochloride ekwivalenti għal 8.31 mg memantine.
English: Dosage The recommended dose of Memantine Mylan for adults and older people is 20 mg once a day.
Maltese: Id-doża rakkomandata ta' Memantine Mylan għall-adulti u persuni anzjani hija ta' 20 mg darba kuljum.
English: • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is coadministered with HCT or any combination with HCT.
Maltese: Jista' jkun hemm possibilità ta' livelli ta' hydrochlorthiazide (HCT) imnaqqsa fis-serum meta memantine jingħata ma' HCT jew kwalunkwe taħlita ma' HCT.
English: NAME OF THE MEDICINAL PRODUCT Memantine Mylan 10 mg film-coated tablets Memantine Mylan 20 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Memantine Mylan 10 mg pilloli miksijin b'rita.Memantine Mylan 20 mg pilloli miksijin b'rita.