FrancophonIA/ELRC3.0 huggingface dataset:
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I), subject to amendments in the product information and conditions on the marketing authorisations; the CVMP has recommended the variations of the marketing authorisations for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I of the opinion) in order to amend the summaries of product characteristics, labelling and package leaflets as set out in annex III.
Maltese: Il-bilanċ ġenerali tal-benefiċċju-riskju għall-prodotti mediċinali veterinarji li fihom enrofloxacin li jingħataw permezz tal-ilma tax-xorb lit-tiġieġ u/jew lid-dundjani (ara anness I) huwa meqjus pożittiv soġġett għat-tibdil rakkomandat fl-informazzjoni dwar il-prodott (ara anness III) u, fid-dawl tal-ħtieġa li tinkiseb aktar dejta sabiex jiġu ndirizzati bis-sħiħ il-kwistjonijiet dwar is-saħħa pubblika li wasslu għal din il-proċedura ta' riferiment, soġġett għall-impożizzjoni ta' kundizzjonijiet li jaffettwaw LAwtorizzazzjonijiet għat-Tqegħid fis-Suq (ara anness IV).
English: Swine, cattle (calves), broiler chickens, dogs, cats
Maltese: Baqar (għoġġiela), ħnieżer, tiġieġ (brojlers), qtates, klieb
English: Lithuania Krka d.d.
Maltese: Il-Litwanja Krka d.d. Novo mesto, Šmarjeska cesta 6
English: Belgium Vetpharma Animal Health S.L.,
Maltese: Is-Slovakkja Vetpharma Animal Health S.L.,
English: • Taking into account the decreases in the susceptibility profiles of E. coli observed in EU surveillance from the time enrofloxacin was first authorised in poultry species, a dosing regimen should be elaborated based on new studies that encompass the current susceptibility of E. coli and new PK/PD concepts aimed at limiting the development of resistance for the target pathogens.
Maltese: • B'kunsiderazzjoni tat-tnaqqis fil-profil ta' suxxettibilità ta' E. coli osservat fis-sorveljanza tal-UE minn meta enrofloxacin kien l-ewwel awtorizzat fl-ispeċi tat-tjur, għandha tiġi elaborata skeda ta' dożaġġ abbażi tal-istudji kollha li tinkludi s-suxxettibilità attwali ta' E. coli u l-kunċetti l-ġodda talPK/PD bil-għan li jiġi limitat l-iżvilupp ta' reżistenza għall-patoġeni fil-mira.
English: The indication for treatment of salmonella infections should be removed from the SPCs due to the lack of support for the dosing regimen, especially in regards to elimination of infection, and EU legislation in regards to national control programmes for the control of salmonella in poultry that state that antimicrobials should not be used except in exceptional circumstances (Regulation EC 1177/2006).
Maltese: L-indikazzjoni għall-kura ta' infezzjonijiet tas-salmonella għandha titneħħa mill-SPCs minħabba nnuqqas ta' appoġġ għall-iskeda ta' dożaġġ, speċjalment fir-rigward tal-eliminazzjoni tal-infezzjoni, u lleġiżlazzjoni tal-UE fir-rigward ta' programmi ta' kontroll nazzjonali għall-kontroll tas-salmonella fit-tjur li tgħid li l-antimikrobiċi m'għandhomx jintużaw ħlief f'ċirkustanzi eċċezzjonali (Regolament KE 1177/2006).
English: Given the inter-individual variability surrounding Css values and the fact that several studies quoted MIC90 values for enrofloxacin against E. coli of 0.5-1 µg/ml, it seems that plasma concentrations greater than the MIC would not be achieved in all individuals against all isolates.
Maltese: Minħabba l-varjabbiltà bejn l-individwi tal-valuri tas-Css u l-fatt li bosta studji kkwotaw valuri tal-MIC90 ta' 0.5-1 µg/ml għal enrofloxacin kontra E. coli, jidher li konċentrazzjonijiet fil-plasma ogħla mill-MIC mhumiex se jintlaħqu fl-individwi kollha kontra l-iżolati kollha.
English: MIC data were provided for enrofloxacin against target pathogens (E.coli, P. multocida, M. gallisepticum, M. synoviae) isolated from respiratory tract infections or septicaemia in poultry.
Maltese: Dejta dwar il-MIC ġiet ipprovduta għal enrofloxacin kontra l-patoġeni fil-mira (E.coli, P. multocida, M. gallisepticum, M. synoviae) iżolati minn infezzjonijiet fl-apparat respiratorju jew settiċemija fit-tjur.
English: Add, to all products: 4.4 Special warnings for each target species
Maltese: Żid, għall-prodotti kollha: 4.4
English: Broilers, rearing poultry, turkeys
Maltese: Brojlers, tjur għattrobbija, dundjani
English: Germany Vetpharma Animal Health S.L.,
Maltese: L-Ungerija Vetpharma Animal Health S.L.,
English: 24010 Leon, Spain
Maltese: Leon, Spanja
English: Krka d.d.
Maltese: S.R.L.
English: They show that 10 mg/kg bw enrofloxacin was efficacious in reducing mortality and morbidity and that there was reduction in pathogen re-isolation for up to 4 weeks after inoculation.
Maltese: Dawn juru li 10 mg/kg tal-piż tal-ġisem ta' enrofloxacin kien effikaċi fit-tnaqqis talmortalità u l-morbidità u li kien hemm tnaqqis fir-ri-iżolament tal-patoġenu sa 4 ġimgħat wara ttilqima.
English: This would indicate that suitable levels are not reached in lung tissue for efficacy against Mycoplasma spp with an MIC of ≥1 µg/ml.
Maltese: Dan jindika li b'MIC ta' ≥1 µg/ml mhumiex qed jintlaħqu livelli adegwat fit-tessut tal-pulmun għall-effikaċja kontra Mycoplasma spp.
English: The full EPAR for Entecavir Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Entecavir Accord entecavir
Maltese: Informazzjoni oħra dwar Entecavir Accord
English: The active substance in Entecavir Accord, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Maltese: Is-sustanza attiva f'Entecavir Accord, l-entecavir, hija antivirali li tappartjeni għall-klassi tal-analogi nukleosidiċi.
English: This is a summary of the European public assessment report (EPAR) for Entecavir Accord.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Entecavir Accord.
English: Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir may be available for children weighing less than 32.6 kg. For further information, see the package leaflet.
Maltese: Tfal li jiżnu 32.6 kg u aktar jistgħu jingħataw il-pilloli ta' 0.5 mg, filwaqt li għal tfal li jiżnu inqas minn 32.6 kg, tista' tkun disponibbli soluzzjoni orali ta' entecavir.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku entecavir
English: Entecavir Accord contains the active substance entecavir and is a ‘generic medicine'.
Maltese: Entecavir Accord fih is-sustanza attiva entecavir u huwa ‘mediċina ġenerika'.
English: Entecavir Accord is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Maltese: Entecavir Accord huwa mediċina li tintuża biex tikkura epatite B kronika (fit-tul) (marda infettiva talfwied, ikkawżata mill-virus tal-epatite B).
English: Entecavir Accord can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg).
Maltese: Entecavir Accord jista' jinkiseb biss b'riċetta ta' tabib u jiġi bħala pilloli (0.5 mg u 1 mg).
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Accord.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Baraclude, u ma għandhomx għalfejn jiġu ripetuti għal Entecavir Accord.
English: What are the benefits and risks of Entecavir Accord?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Entecavir Accord?
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara ddokument ta'mistoqsijiet-u-tweġibiet hawnhekk.
English: Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Maltese: L-entecavir tinterferixxi mal-azzjoni ta' enzima virali, polimerażi tad-DNA, li hija involuta fil-formazzjoni ta' DNA virali.
English: For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Accord (a nucleoside analogue, such as lamivudine).
Maltese: Għal adulti b'mard tal-fwied ikkumpensat, id-doża tiddependi minn jekk il-pazjent ġiex ikkurat qabel jew le b'mediċina fl-istess grupp ta' Entecavir Accord (analogu nukleosidiku, bħal lamivudine).
English: How has Entecavir Accord been studied?
Maltese: Kif ġie studjat Entecavir Accord?
English: Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose.
Maltese: Il-pazjenti li ma ġewx ikkurati qabel b'analogu nukleosidiku jirċievu doża ta' 0.5 mg, filwaqt li dawk li rċevew lamivudine qabel iżda li l-infezzjoni tagħhom m'għadhiex tirrispondi aktar għalih jingħataw doża ta' 1 mg.
English: This means that Entecavir Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Baraclude.
Maltese: Dan ifisser li Entecavir Accord fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Baraclude.
English: Because Entecavir Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Entecavir Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The Agency recommended that Entecavir Accord be approved for use in the EU.
Maltese: L-Aġenzija rrakkomandat li Entecavir Accord ikun approvat għall-użu fl-UE.
English: Why is Entecavir Accord approved?
Maltese: Għaliex ġie approvat Entecavir Accord?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Accord has been shown to have comparable quality and to be bioequivalent to Baraclude.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Entecavir Accord wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Baraclude.
English: How is Entecavir Accord used?
Maltese: Kif jaħdem Entecavir Accord?
English: Treatment with Entecavir Accord should be started by a doctor with experience in the management of chronic hepatitis B.
Maltese: Il-kura b'Entecavir Accord għandha tinbeda minn tabib li jkollu esperjenza fil-ġestjoni tal-epatite B kronika.
English: As for every medicine, the company provided studies on the quality of Entecavir Accord.
Maltese: Bħal kull mediċina oħra, il-kumpanija pprovdiet studji dwar il-kwalità ta' Entecavir Accord.
English: Therefore, the Agency's view was that, as for Baraclude, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, ilfehma tal-Aġenzija kienet li, bħal fil-każ ta' Baraclude, il-benefiċċju huwa akbar mir-riskju identifikat.
English: Exelon 10 cm N = 271
Maltese: Exelon 10 ċm N = 271
English: Date of first authorisation: 12 May 1998 Date of latest renewal: 20 May 2008
Maltese: Data tal-aħħar tiġdid: 20 Mejju 2008
English: Exelon contains sodium benzoate
Maltese: Exelon fih sodium benzoate
English: What Exelon contains - The active substance is rivastigmine hydrogen tartrate.
Maltese: X'fih Exelon - Is-sustanza attiva hija rivastigmine hydrogen tartrate.
English: Absolute bioavailability after a 3 mg dose is about 36%  13%.
Maltese: Iż-żieda assoluta fir-rata ta' biodisponibilità, wara doża ta' 3 mg, hija ta' madwar 36%13%.
English: Exelon 2 mg/ml [folding box only]
Maltese: Exelon 2 mg/ml [kaxxa li tintlewa biss]
English: Exelon 15 cm N = 265
Maltese: Exelon 15 ċm N = 265
English: The outer layer is beige and labelled with the following: - “Exelon”, “4.6 mg/24 h” and “AMCX”, - “Exelon”, “9.5 mg/24 h” and “BHDI”, - “Exelon”, “13.3 mg/24 h” and “CNFU”.
Maltese: barra huwa bex u ttikkettat b'dawn li jmiss: - “Exelon”, “4.6 mg/24 h” u “AMCX”, - “Exelon”, “9.5 mg/24 h” u “BHDI”, - “Exelon”, “13.3 mg/24 h” u “CNFU”.
English: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8);
Maltese: • lill-pazjenti b'sindrome ta' sinus marid jew difetti tal-konduzzjoni (imblukkar sinoatrijali, imblukkar atrijuventrikulari) (ara sezzjoni 4.8);
English: Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochrome isoenzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Maltese: Skont studji in vitro, mhix mistennija ebda interazzjoni farmakokinetika bi prodotti mediċinali metabolizzati mill-iżoenzimi tas-cytochrome li ġejjin: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, jew CYP2B6.
English: Exelon capsules 12 mg/day
Maltese: Exelon kapsuli 12 mg/jum
English: Exelon 2 mg/ml oral solution rivastigmine
Maltese: Exelon 2 mg/ml soluzzjoni orali rivastigmine
English: Exelon 9 mg/5 cm 2, 18 mg/10 cm and 27 mg/15 cm transdermal patches are individually packaged in child-resistant, heat-sealed sachets made of a paper/polyethyleneterephthalate/aluminum/polyacrylnitrile (PAN) multi-laminated material (paper/PET/alu/PAN) or in heat-sealed, child-resistant sachets made of multi-layer composite laminate consisting of paper/polyethylene terephthalate/polyethylene/aluminum/polyamide (paper/PET/PE/alu/PA).
Maltese: 27 mg/15 ċm huma ppakkjati individwalment fi qratas reżistenti għat-tfal u ssiġillati bis-sħana magħmulin minn materjal multilaminat li jinkludi karta/polietilen tereftalat/aluminju/polyacrylnitrile (PAN) (karta/PET/alu/PAN) jew fi qratas issiġillati bis-sħana u reżistenti għat-tfal magħmulin minn laminat kompost b'bosta saffi li jikkonsisti f'karta/polietilen tereftalat/polietilen/aluminju/poliammid (karta/PET/PE/alu/PA).
English: Exelon 1.5 mg hard capsules Exelon 3.0 mg hard capsules Exelon 4.5 mg hard capsules Exelon 6.0 mg hard capsules
Maltese: Exelon 1.5 mg kapsuli ibsin Exelon 3.0 mg kapsuli ibsin Exelon 4.5 mg kapsuli ibsin Exelon 6.0 mg kapsuli ibsin
English: Exelon 1.5 mg hard capsules Exelon 3.0 mg hard capsules Exelon 4.5 mg hard capsules Exelon 6.0 mg hard capsules rivastigmine
Maltese: Exelon 1.5 mg kapsuli ibsin Exelon 3.0 mg kapsuli ibsin Exelon 4.5 mg kapsuli ibsin Exelon 6.0 mg kapsuli ibsin rivastigmine
English: Other medicines and Exelon
Maltese: Mediċini oħra u Exelon
English: Transdermal patches Rivastigmine in vivo release rates per 24 h
Maltese: Rata ta' ħelsien ta' Rivastigmine in vivo kull 24 siegħa
English: Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with Exelon capsules.
Maltese: Tabella 2 turi reazzjonijiet avversi rrappurtati waqt studji kliniċi mwettqa f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson ikkurati bil-kapsuli Exelon.
English: The fluctuation index (FI), a measure of the relative difference between peak and trough concentrations ((Cmax-Cmin)/Cavg), was 0.58 for Exelon 4.6 mg/24 h transdermal patches, 0.77 for Exelon 9.5 mg/24 h transdermal patches and 0.72 for Exelon 13.3 mg/24 h transdermal patches, thus demonstrating a much smaller fluctuation between trough and peak concentrations than for the oral formulation (FI = 3.96 (6 mg/day) and 4.15 (12 mg/day)).
Maltese: L-indiċi ta' fluttwazzjoni (FI), kejl tad-differenza relattiva bejn l-ogħla konċentrazzjonijiet u dawk l-aktar baxxi ((Cmax-Cmin)/Cavg), kien 0.58 għal garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon 4.6 mg/24 siegħa, 0.77 għal garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon 9.5 mg/24 siegħa u 0.72 għal garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon 13.3 mg/24 siegħa, b'hekk dehret fluttwazzjoni iżgħar bejn l-ogħla konċentrazzjonijiet u dawk l-aktar baxxi minn b'dik tal-formulazzjoni orali (FI = 3.96 (6 mg/jum) u 4.15 (12 mg/jum)).
English: • Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna war JIS/EXP.
English: The active substance of Exelon is rivastigmine.
Maltese: Is-sustanza attiva f'Exelon hija rivastigmine.
English: Each Exelon 1.5 mg capsule contains 1.5 mg of rivastigmine.
Maltese: Kull kapsula Exelon ta' 1.5 mg fiha 1.5 mg rivastigmine.
English: The outside of the backing layer is beige and labelled with “Exelon”, “4.6 mg/24 h” and “AMCX”.
Maltese: In-naħa ta' barra tas-saff ta' wara huwa bex u tikkettat b'“Exelon”, “4.6 mg/24 h” u “AMCX”.
English: Exelon 15 cm2
Maltese: Exelon 15 ċm
English: Exelon 13.3 mg/24 h transdermal patches: Each patch releasing 13.3 mg of rivastigmine per 24 hours is 15 cm and contains 27 mg of rivastigmine.
Maltese: Kull garża terħi 13.3 mg ta' rivastigmine kull 24 siegħa, hija 15 cm u fiha 27 mg rivastigmine.
English: Exelon 2 mg/ml oral solution
Maltese: IL-PRODOTT MEDIĊINALI Exelon 2 mg/ml soluzzjoni orali
English: One of the inactive ingredients in Exelon oral solution is sodium benzoate.
Maltese: Waħda mis-sustanżi mhux attivi ta' Exelon soluzzjoni orali hija sodium benzoate.
English: Each Exelon 6.0 mg capsule contains 6.0 mg of rivastigmine.
Maltese: Kull kapsula Exelon ta' 6.0 mg fiha 6.0 mg rivastigmine.
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Exelon in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Maltese: Tabella 3 telenka n-numru u l-perċentwal ta' pazjenti minn studju kliniku speċifiku ta' 24-gimgha li sar b'Exelon f'pazjenti bid-dimenzja assoċjata mal-marda ta' Parkinson b'każijiet avversi li kienu ddefiniti minn qabel li jistgħu jirriflettu aggravament tas-sintomi tal-marda ta' Parkinson.
English: Each Exelon 4.5 mg capsule contains 4.5 mg of rivastigmine.
Maltese: Kull kapsula Exelon ta' 4.5 mg fiha 4.5 mg rivastigmine.
English: Exelon 6.0 mg hard capsules rivastigmine
Maltese: Exelon 6.0 mg kapsuli ibsin rivastigmine
English: There is no relevant use of Exelon in the paediatric population in the treatment of Alzheimer's disease.
Maltese: M'hemmx użu relevanti ta' Exelon fil-popolazzjoni pedjatrika għat-trattament tal-marda ta' Alzheimer.
English: - Exelon 9.5 mg/24 h transdermal patches: Each patch releasing 9.5 mg of rivastigmine per 24 hours is 10 cm and contains 18 mg of rivastigmine.
Maltese: Kull garża terħi 9.5 mg ta' rivastigmine kull 24 siegħa, hija 10 cm u fiha 18 mg rivastigmine.
English: Exelon 1.5 mg hard capsules rivastigmine
Maltese: Exelon 1.5 mg kapsuli ibsin rivastigmine
English: The following adverse reactions have only been observed with Exelon capsules and oral solution and not in clinical studies with Exelon transdermal patches: malaise, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Maltese: Ir-reazzjonijiet avversi li ġejjin dehru biss bil-kapsuli u soluzzjoni orali Exelon u mhux fl-istudji kliniċi b'garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda: nuqqas ta' saħħa, konfużjoni, żieda flgħaraq (komuni); ulċeri fid-duwodenu, anġina pektoris (rari); emorraġija gastrointestinali (rari ħafna); u xi każijiet ta' rimettar sever kienu assoċjati ma tiċrit fl-esofagu (mhux magħruf).
English: Exelon 4.5 mg hard capsules rivastigmine
Maltese: Exelon 4.5 mg kapsuli ibsin rivastigmine
English: ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Exelon 15 cm as compared to Exelon 10 cm
Maltese: Punteġġi ADAS-cog: Differenza negattiva fid-DLSM tindika titjib akbar f'Exelon 15 ċm2 meta mqabbel ma' Exelon 10 ċm Punteġġi ADCS-IADL:
English: Exelon 3.0 mg hard capsules rivastigmine
Maltese: Exelon 3.0 mg kapsuli ibsin rivastigmine
English: In other cases, Exelon has been discontinued (see section 4.8).
Maltese: F'każijiet oħra, Exelon ġie mwaqqaf (ara sezzjoni 4.8).
English: 42 transdermal patches.
Maltese: 24 siegħa wara d-doża eċċessiva.
English: Exelon 4.5 mg hard capsules
Maltese: Exelon 4.5 mg kapsuli ibsin
English: Each Exelon 3.0 mg capsule contains 3.0 mg of rivastigmine.
Maltese: Kull kapsula Exelon ta' 3.0 mg fiha 3.0 mg rivastigmine.
English: Exelon 4.6 mg/24 h transdermal patches and Exelon 9.5 mg/24 h transdermal patches are available in packs containing 7, 30 or 42 sachets and in multipacks containing 60, 84 or 90 sachets.
Maltese: Exelon 4.6 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda Jiġi f'pakketti li jkun fihom 7, 30 jew 42 qartas u f'pakketti b'ħafna li jkollhom 60, 84 jew 90 qartas.
English: The outside of the backing layer is beige and labelled with “Exelon”, “13.3 mg/24 h” and “CNFU”.
Maltese: In-naħa ta' barra tas-saff ta' wara huwa bex u tikkettat b'“Exelon”, “13.3 mg/24 h” u “ CNFU”.
English: - Exelon 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “EXELON 4,5 mg” on the body.
Maltese: - Exelon 4.5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u korp aħmar, b'timbru aħmar “EXELON 4,5 mg” fuq il-korp.
English: Table 1 displays the adverse reactions reported in 1,670 patients with Alzheimer's dementia treated in randomised, double-blind, placebo and active-controlled clinical studies with Exelon transdermal patches for a duration of 24-48 weeks and from post-marketing data.
Maltese: Tabella 1 turi r-reazzjonijiet avversi rrappurtati fi 1,670 pazjent bid-dimenzja ta' Alzheimer ikkurati fi studji kliniċi randomizzati, double-blind u kkontrollati bi plaċebo u b'mod attiv bil-garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda Exelon u doża mmirata ta' 9.5 mg/24 siegħa għal perjodu ta' 24-48 ġimgħa u mid-data ta' wara t-tqegħid tal-prodott fis-suq.
English: What Exelon looks like and contents of the pack - Exelon 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on the body.
Maltese: Kif jidher Exelon u l-kontenut tal-pakkett - Exelon 1.5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu isfar u korp isfar, b'timbru aħmar “EXELON 1,5 mg” fuq il-korp.
English: The outside of the backing layer is beige and labelled with “Exelon”, “9.5 mg/24 h” and “BHDI”.
Maltese: In-naħa ta' barra tas-saff ta' wara huwa bex u tikkettat b'“Exelon”, “9.5 mg/24 h” u “ BHDI”.
English: Exelon 6.0 mg hard capsules
Maltese: Exelon 6.0 mg kapsuli ibsin
English: Exelon 3.0 mg hard capsules
Maltese: Exelon 3.0 mg kapsuli ibsin
English: Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “EXELON 3 mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu oranġjo u korp oranġjo, u stampata bl-aħmar “EXELON 3 mg” fuq il-korp.
English: Polyester film, fluoropolymer-coated
Maltese: Rita ta' polyester, miksija bi fluoropolymer 6.2 Inkompatibbiltajiet
English: Exelon 1.5 mg hard capsules
Maltese: Exelon 1.5 mg kapsuli ibsin
English: - Exelon 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “EXELON 3 mg” on the body.
Maltese: - Exelon 3.0 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu oranġjo u korp oranġjo, b'timbru aħmar “EXELON 3 mg” fuq il-korp.
English: - Exelon 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “EXELON 6 mg” on the body.
Maltese: - Exelon 6.0 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u korp oranġjo, b'timbru aħmar “EXELON 6 mg” fuq il-korp.