FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common adverse reactions were infusion-related reactions.
Maltese: L-aktar reazzjonijiet avversi komuni kienu r-reazzjonijiet relatati mal-infużjoni.
English: Apart from symptoms associated with hypersensitivity reactions IRRs might show as fatigue, dizziness, pyrexia, blood pressure increase, pruritus, or vision blurred.
Maltese: Minbarra s-sintomi assoċjati ma' reazzjonijiet ta' sensittività eċċessiva, IRRs jistgħu jidhru bħala għeja, sturdament, deni, żieda fil-pressjoni tad-demm, ħakk jew vista mċajpra.
English: Infusion-related reaction, asthenia/fatigue, pyrexia/body temperature increased
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata reazzjoni relatata malinfużjoni, astenja/għeja, deni/temperatura għolja tal-ġisem
English: How to store VPRIV
Maltese: Reazzjoni avversa
English: The mean absolute increase from baseline in haemoglobin concentrations was 1.624 g/dl (±0.223 SE) following 9 months of treatment with velaglucerase alfa.
Maltese: Iż-żieda assoluta medja mil-linja bażi fil-konċentrazzjonijiet tal-emoglobina kienet ta' 1.624 g/dl (±0.
English: The most serious adverse reactions in patients in clinical trials were hypersensitivity reactions.
Maltese: L-aktar reazzjonijiet avversi serji f'pazjenti fil-provi kliniċi kienu reazzjonijiet ta' sensittività eċċessiva.
English: Talk to your doctor before VPRIV is used - If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects).
Maltese: Kellem lit-tabib tiegħek qabel jintuża VPRIV - Jekk tingħata trattament b'VPRIV, jista' jkollok effetti sekondarji waqt jew wara l-infużjoni (ara sezzjoni 4, Effetti sekondarji possibli).
English: This was a multicentre, open-label study in which 60 U/kg of velaglucerase alfa was administered by intravenous infusion every other week (EOW) over 12 months in 6 patients (2 to 17 years of age at enrolment) with a confirmed diagnosis of type 3 Gaucher disease.
Maltese: U/kg ta' velaglucerase alfa ngħataw permezz ta' infużjoni ġol-vini kull ġimagħtejn (EOW, every other week) fuq perijodu ta' 12-il xahar f'6 pazjenti (li kellhom minn sentejn sa 17-il sena meta rreġistraw fl-istudju) b'dijanjosi kkonfermata tal-marda ta' Gaucher ta' tip 3.
English: Sustained clinical activity continued to be demonstrated during treatment as observed by improvements in haemoglobin concentrations and platelet counts and reduced liver and spleen volumes.
Maltese: L-attività klinika sostnuta kompliet tintwera matul it-trattament, kif ġie osservat mit-titjib fil-konċentrazzjonijiet tal-emoglobina u n-numru ta' plejtlits u l-volumi fil-fwied u l-milsa.
English: Prevention and Management of infusion related reactions including hypersensitivity reactions The management of infusion-related reactions should be based on the severity of the reaction, and include slowing the infusion rate, treatment with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time.
Maltese: Il-ġestjoni tar-reazzjonijiet relatati mal-infużjoni għandha tkun ibbażata fuq is-severità tar-reazzjoni u għandha tinkludi t-tnaqqis tar-rata ta' infużjoni, il-kura bi prodotti mediċinali bħal antistamini, antipiretiċi u/jew kortikosterojdi, u/jew il-waqfien u l-bidu mill-ġdid tat-trattament b'żieda fil-ħin talinfużjoni.
English: VPRIV 400 Units powder for solution for infusion
Maltese: VPRIV 400 unità trab għal soluzzjoni għall-infużjoni
English: The studies allowed the inclusion of patients 2 years and older and the safety and efficacy profiles are expected to be similar down to the age of 2 years.
Maltese: L-istudji ppermettew l-inklużjoni ta' pazjenti ta' sentejn u iktar u l-profili ta' sigurtà u taleffikaċja huma mistennija li jkunu simili sal-età ta' 2 sentejn.
English: Respiratory, thoracic and mediastinal disorders dyspnea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali qtugħ ta' nifs
English: The safety profile of VPRIV in clinical studies involving patients aged 65 years and above was similar to that observed in other adult patients.
Maltese: Il-profil ta' sigurtà ta' VPRIV fl-istudji kliniċi li jinvolvu lil pazjenti ta' 65 sena jew aktar kien simili għal dak osservat f'pazjenti adulti oħrajn.
English: The European Medicines Agency has waived the obligation to submit the results of studies with VPRIV in all subsets of the paediatric population with type 2 Gaucher disease.
Maltese: Jeħtieġ rikostituzzjoni u dilwizzjoni u huwa maħsub għall-infużjoni ġol-vini biss.
English: This enzymatic deficiency causes an accumulation of glucocerebroside primarily in macrophages, giving rise to foam cells or "Gaucher cells".
Maltese: Dan in-nuqqas ta' enzimi jikkawża akkumulazzjoni ta' glucocerebroside l-aktar f'makrofaġi, li joħloq ċelloli fowm jew “ċelloli Gaucher”.
English: Other medicines and VPRIV
Maltese: Mediċini oħra u VPRIV
English: VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease.
Maltese: Skont l-għarfien disponibbli attwalment tal-farmakokinetika u l-farmakodinamika ta' velaglucerase alfa, ma huwa rrakkomandat l-ebda aġġustament fid-doża fil-pazjenti b'indeboliment renali jew epatiku.
English: There are 5 potential N-linked glycosylation sites, four of which are occupied.
Maltese: Hemm 5 siti potenzjali ta' glikosilazzjoni marbuta mal-N, li erbgħa minnhom huma okkupati.
English: In this small, exploratory study, the non-neurological efficacy findings and the safety profile of intravenous velaglucerase alfa in type 3 Gaucher patients were consistent with those observed in patients with type 1 Gaucher disease.
Maltese: F'dan l-istudju esploratorju żgħir, ir-riżultati mhux newroloġiċi tal-effikaċja u l-profil tas-sigurtà ta' velaglucerase alfa mogħti ġol-vini f'pazjenti bil-marda ta' Gaucher ta' tip 3, kienu konsistenti ma' dawk osservati f'pazjenti bil-marda ta' Gaucher ta' tip 1.
English: The marketing authorisation holder is Boehringer Ingelheim International GmbH.
Maltese: Id-detentur ta-awtorizzazzjoni huwa Boehringer Ingelheim International GmbH.
English: The full EPAR for Mirapexin can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Mirapexin jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Mirapexin, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine).
Maltese: Is-sustanza attiva f'Mirapexin, pramipexole, hija agonista tad-dopamina (sustanza li timita l-azzjoni tad-dopamina).
English: Mirapexin is a medicine that contains the active substance pramipexole.
Maltese: Mirapexin huwa mediċina li fiha s-sustanza attiva pramipexole.
English: This document is a summary of the European Public Assessment Report (EPAR) for Mirapexin.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR) għal Mirapexin.
English: Four studies compared Mirapexin with placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa.
Maltese: Erba' studji qabblu Mirapexin ma' plaċebo (trattament finta): studju minnhom twettaq fuq 360 pazjent bilmarda avvanzata li diġà kienu qegħdin jieħdu levodopa li kien qed isir inqas effikaċi, u tliet studji twettqu f'total ta' 886 pazjent bil-marda fl-istadju inizjali li ma kinux qegħdin jieħdu levodopa.
English: In restless legs syndrome, Mirapexin immediate-release tablets were more effective than placebo at reducing symptoms over 12 weeks, but the difference between placebo and Mirapexin was greatest after four weeks before getting smaller.
Maltese: Fis-sindromu tar-riġlejn irrekwieti, il-pilloli Mirapexin b'rilaxx immedjat kienu iktar effikaċi mill-plaċebo fit-tnaqqis tas-sintomi tul 12-il ġimgħa, iżda d-differenza bejn il-plaċebo u Mirapexin kienet l-iktar evidenti wara erba' ġimgħat qabel ma din reġgħet naqset.
English: The second included 150 patients who took Mirapexin for six months, and compared the effects of remaining on Mirapexin with switching to placebo.
Maltese: It-tieni wieħed inkluda 150 pazjent li ħadu Mirapexin tul sitt xhur, u qabbel l-effetti ta' meta pazjent jibqa' jieħu Mirapexin jew jaqleb għal plaċebo.
English: What is Mirapexin?
Maltese: X'inhu Mirapexin?
English: The marketing authorisation is valid for an unlimited period.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq hija valida għal perjodu indefinit.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mirapexin on 23 February 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Mirapexin fit-23 ta' Frar 1998.
English: Why has Mirapexin been approved?
Maltese: Għaliex ġie approvat Mirapexin?
English: What is the risk associated with Mirapexin?
Maltese: X'inhu r-riskju assoċjat ma' Mirapexin?
English: Mirapexin is used to treat the symptoms of the following diseases:
Maltese: Mirapexin jintuża fit-trattament tas-sintomi tal-mard li ġej:
English: The first compared Mirapexin with placebo over 12 weeks in 344 patients and measured the improvement in symptoms.
Maltese: L-ewwel qabbel Mirapexin ma' plaċebo fuq żmien ta' 12-il ġimgħa fi 344 pazjent u kejjel ittitjib tas-sintomi.
English: The fifth study compared Mirapexin with levodopa in 300 patients with early disease, and measured the number of patients who had movement symptoms.
Maltese: Il-ħames studji qabbel Mirapexin ma' levodopa fi 300 pazjent bil-marda fl-istadu inizjali, u kkalkula l-għadd ta' pazjenti li kellhom sintomi fil-movimenti.
English: The most common side effect with Mirapexin (seen in more than 1 patient in 10) is nausea (feeling sick).
Maltese: L-effett sekondarju l-aktar komuni bi Mirapexin (li deher f'aktar minn pazjent 1 minn 10) hu nawżea (dardir).
English: In Parkinson's disease, Mirapexin immediate-release tablets have been studied in five main studies.
Maltese: Fil-marda ta' Parkinson, il-pilloli Mirapexin b'rilaxx immedjat ġew studjati f'ħames studji ewlenin.
English: Mirapexin was also more effective than levodopa at improving movement symptoms in early disease.
Maltese: Mirapexin kien iktar effikaċi wkoll minn levodopa fit-titjib tassintomi tal-moviment fil-marda fl-istadju inizjali.
English: In restless legs syndrome, Mirapexin immediate-release tablets have been studied in two main studies.
Maltese: Fis-sindromu tar-riġlejn irrekwieti, il-pilloli Mirapexin b'rilaxx immedjat ġew studjati f'żewġ studji ewlenin.
English: Mirapexin can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Maltese: Mirapexin jista' jintuża jew waħdu jew flimkien ma' levodopa (mediċina oħra għall-marda ta' Parkinson), f'kull stadju tal-marda inkluż fl-aħħar stadji meta levodopa jibda jkun anqas effikaċi.
English: For the full list of all side effects reported with Mirapexin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati ma' Mirapexin, ara l-fuljett ta' tagħrif.
English: Other information about Mirapexin:
Maltese: Aktar tagħrif dwar Mirapexin:
English: Mirapexin must be given less often in patients who have problems with their kidneys.
Maltese: Mirapexin għandu jingħata anqas ta' spiss lil pazjenti li għandhom problemi fil-kliewi tagħhom.
English: Mirapexin is used when a specific cause for the disorder cannot be identified.
Maltese: Mirapexin jintuża meta ma tistax tiġi identifikata kawża speċifika għad-disturb.
English: By the end of Q3 2015 Within 3 months after CMDh agreement
Maltese: Sat-tmiem tal-Q3 tal-2015
English: The MAH should conduct a prospective non-interventional postauthorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice.
Maltese: Il-MAH għandu jwettaq studju prospettiv mhux ta' intervent wara lawtorizzazzjoni dwar is-sigurtà biex ikomplu jiġu vvalutati l-livelli ta' manjesju osservati fit-trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u fi tfal sa sentejn li jirċievu kura b'Numeta G16%E filprattika klinika ta' rutina.
English: Conditions to the marketing authorisations for Numeta G16%E and associated names
Maltese: Kondizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal Numeta G16%E u ismijiet assoċjati
English: The MAH should submit a revised risk management plan including proposals for evaluating the effectiveness of the risk minimisation measures.
Maltese: Il-MAH għandu jissottometti pjan rivedut għall-ġestjoni tar-riskju inkluż proposti għall-valutazzjoni tal-effikaċja tal-miżuri għallminimizzazzjoni tar-riskji.
English: National competent authorities of Member States or reference Member State if applicable, shall ensure that the following conditions are fulfilled by the MAH for Numeta G16%E:
Maltese: L-Awtoritajiet kompetenti nazzjonali tal-Istati Membri jew tal-Istat Membru ta' referenza jekk applikabbli, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mill-MAH għal Numeta G16%E:
English: Within 3 months after CMDh agreement
Maltese: Fi żmien 3 xhur wara lftehim tas-CMDh
English: West Nile virus strain VM-2
Maltese: Razza VM-2 tal-vajrus West Nile
English: It is available as an emulsion for injection.
Maltese: Huwa disponibbli bħala emulsjoni għall-injezzjoni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Equip WNV on 21 November 2008.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Equip WNV fil-21 ta' Novembru 2008.
English: Equip WNV is a vaccine that contains inactivated (killed) West Nile virus.
Maltese: Equip WNV huwa vaċċin li fih vajrus West Nile inattivat (maqtul).
English: West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses.
Maltese: Il-vajrus West Nile huwa infezzjoni li tiġi trasmessa min-nemus u tista' tikkawża mard serju u infezzjonijiet fatali tal-moħħ fiż-żwiemel infettati.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equip WNV outweigh the risks for the approved indication and recommended that Equip WNV be given a marketing authorisation.
Maltese: Il-Kumitat dwar il-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Equip WNV huma akbar mir-riskji għall-indikazzjoni approvata u rrakkomanda li Equip WNV jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is the risk associated with Equip WNV?
Maltese: X'inhu r-riskju assoċjat ma' Equip WNV?
English: Equip WNV is used to vaccinate horses from six months of age against West Nile virus.
Maltese: Equip WNV jintuża fit-tlaqqim ta' żwiemel mill-età ta' sitt xhur kontra l-vajrus West Nile.
English: In addition a laboratory study was performed in which vaccinated and non-vaccinated horses were injected with West Nile virus lineage 2 directly into the central nervous system three weeks after initial vaccination.
Maltese: Barra minn hekk sar studju fil-laboratorju li fih żwiemel imlaqqma u mhux imlaqqma ġew injettati bit-tip 2 tal-vajrus West Nile direttament fis-sistema nervuża ċentrali tliet ġimgħat wara l-vaċċinazzjoni inizjali.
English: Why has Equip WNV been approved?
Maltese: Għaliex ġie approvat Equip WNV?
English: The vaccine is used to reduce the number of horses with the West Nile virus lineage 1 or 2 in their blood (viraemia) and to reduce the severity and duration of clinical signs of West Nile virus disease caused by lineage 2 strains.
Maltese: Il-vaċċin jintuża sabiex inaqqas in-numru ta' żwiemel bit-tip 1 jew 2 tal-vajrus West Nile fid-demm tagħhom (viremija) u biex inaqqas is-severità u ddewmien tas-sinjali kliniċi tal-mard tal-vajrus West Nile kkawżat minn razez tat-tip 2.
English: The field studies showed that Equip WNV protects horses from West Nile virus by reducing the number of viraemic horses after infection with West Nile virus lineage 1 or 2 strains and by reducing the duration and severity of clinical signs against lineage 2 strains.
Maltese: L-istudji fuq il-post urew li Equip WNV jipproteġi ż-żwiemel mill-vajrus West Nile billi jnaqqas innumru ta' żwiemel viremiċi wara infezzjoni bir-razez tat-tip 1 jew 2 tal-vajrus West Nile u billi jnaqqas id-dewmien u s-severità tas-sinjali kliniċi kontra r-razez tat-tip 2.
English: The effectiveness of Equip WNV was studied in a number of laboratory studies that examined how long it took to achieve protection after vaccination and how long protection lasted in horses injected with West Nile virus lineage 1.
Maltese: L-effikaċja ta' Equip WNV ġiet studjata f'numru ta' studji fil-laboratorju li eżaminaw kemm għadda żmien biex tinkiseb protezzjoni wara l-vaċċinazzjoni u kemm damet il-protezzjoni fiż-żwiemel injettati bit-tip 1 tal-vajrus West Nile.
English: In the future, if the animals are exposed to West Nile virus the immune system will be able to respond more quickly.
Maltese: Fil-futur, jekk l-annimali jkunu esposti għall-vajrus West Nile, is-sistema immunitarja tkun kapaċi tirrispondi b'mod aktar mgħaġġel.
English: What is Equip WNV?
Maltese: Kif jaħdem Equip WNV?
English: When Equip WNV is given to horses, their immune system recognises the virus contained in the vaccine as ‘foreign' and makes antibodies to defend against it.
Maltese: Meta Equip WNV jingħata liż-żwiemel, is-sistema immunitarja tagħhom tagħraf il-vajrus kontenut fil-vaċċin bħala ‘barrani' u tipproduċi antikorpi biex tiddefendi ruħha kontrih.
English: Other information about Equip WNV:
Maltese: Tagħrif ieħor dwar Equip WNV:
English: A small number of animals may show temporary local reactions, in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter), that resolve by themselves within 1 to 2 days.
Maltese: Numru żgħir ta' annimali jistgħu juru reazzjonjiet lokali temporanji wara l-vaċċin fil-forma ta' nefħa lokali żgħira fuq fil-post fejn tkun ingħatat l-injezzjoni (massimu ta' 1 cm ta' dijametru).
English: As with any vaccine rare, occasional allergic reactions may occur.
Maltese: Bħal bi kwalunkwe vaċċin ieħor jistgħu jseħħu reazzjonijiet allerġiċi rari, okkażjonali.
English: Outbreaks of West Nile virus in Europe have been caused by two strains of the virus called lineage 1 and lineage 2.
Maltese: It-tifqigħat tal-vajrus West Nile fl-Ewropa kienu kkawżati minn żewġ razez tal-vajrus imsejħa tip 1 u tip 2.
English: How has Equip WNV been studied?
Maltese: Kif ġie studjat Equip WNV?
English: The vaccine also contains an ‘adjuvant' to enhance the immune response.
Maltese: Il-vaċċin fih ukoll ‘aġġuvant' biex itejjeb ir-rispons immunitarju.
English: The laboratory studies showed that horses developed protection three weeks after the primary vaccination course.
Maltese: L-istudji fil-laboratorju wrew li ż-żwiemel żviluppaw protezzjoni tliet ġimgħat wara l-kors talvaċċinazzjoni primarja.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Maltese: You can also report side effects directly via the national reporting system listed in Appendix V.
English: INFORMATION IN BRAILLE Nemdatine 5 mg, 10 mg, 15 mg, 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Nemdatine 5 mg, 10 mg, 15, mg, 20 mg
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Maltese: By reporting side effects you can help provide more information on the safety of this medicine.
English: Day 22, 23, 24, 25, 26, 27, 28
Maltese: Jum 22, 23, 24, 25, 26, 27, 28
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 reazzjonijiet avversi li seħħew ta' spiss fil-grupp ta' Nemdatine 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: Microcrystalline cellulose Crospovidone Type A Talc
Maltese: Microcrystalline cellulose Crospovidone Tip A Talc
English: Lactose monohydrate
Maltese: Nemdatine fih lactose monohydrate
English: Week 4 (day 22-28):
Maltese: Ġimgħa 4 (jum 22-28):
English: <[For HDPE bottle only:]>
Maltese: <[Għal flixkun HDPE biss:]>
English: Day 15, 16, 17, 18, 19, 20, 21
Maltese: Jum 15, 16, 17, 18, 19, 20, 21 Nemdatine 20 mg
English: Week 1 (day 1-7):
Maltese: Ġimgħa 1 (jum 1-7):
English: Week 3 (day 15-21):
Maltese: Ġimgħa 3 (jum 15-21):
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: Day 8, 9, 10, 11, 12, 13, 14
Maltese: Jum 8, 9, 10, 11, 12, 13, 14 Nemdatine 15 mg
English: Manufacturer Actavis hf.
Maltese: Manifattur Actavis hf.
English: Not known Psychotic reactions2
Maltese: Alluċinazzjonijiet1 Mhux magħruf Reazzjonijiet psikotiċi2
English: Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets.
Maltese: Pakketti b'folji: 28, 30, 42, 50, 56, 60, 98 u 112 pillola miksija b'rita.
English: Day 1, 2, 3, 4, 5, 6, 7
Maltese: Jum 1, 2, 3, 4, 5, 6, 7 Nemdatine 10 mg
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' April 2013
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
Maltese: komuni ħafna (≥ 1/10) komuni (≥1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari
English: Paediatric population No data are available.
Maltese: M'hemm l-ebda data disponibbli.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta'intolleranza' għal galactose, defiċjenza ta' Lapp lactase jew glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Pack sizes
Maltese: Pakkett ta' daqs
English: Crospovidone Type A
Maltese: Mir- 4 ġimgħa
English: HDPE bottle.
Maltese: Flixkun tal-HDPE.
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: PVC/PVDC-Aluminium blisters.
Maltese: Folja ta' aluminjum- PVC/PVDC.
English: INFORMATION IN BRAILLE Nemdatine 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Nemdatine 20 mg
English: Other medicines and Nemdatine
Maltese: Mediċini oħra u Nemdatine