FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, based on the assessment of the MAHs' proposals and responses and following the discussions of the Committee, the CHMP adopted harmonised sets of product information documents of Ikorel and associate names and Dancor and associated names.
Maltese: Bħala konklużjoni, fuq il-bażi tal-valutazzjoni tal-proposti u r-risponsi tal-MAHs u wara ddiskussjonijiet tal-Kumitat, is-CHMP adotta settijiet armonizzati ta' dokumenti ta' informazzjoni dwar il-prodott ta' Ikorel u ismijiet assoċjati u Dancor u ismijiet assoċjati.
English: NSAIDs can cause clinically important damage of the gastrointestinal tract, increasing the incidence of bleeding in the upper gastrointestinal tract and of perforation, although serious complications and death are relatively infrequent.
Maltese: L-NSAIDs jistgħu jikkawżaw ħsara klinikament importanti tal-passaġġ gastrointestinali, iżidu l-inċidenza ta' fsada fil-passaġġ gastrointestinali ta' fuq u ta' perforazzjoni, għalkemm kumplikazzjonijiet serji u mewt huma relattivament infrekwenti.
English: dose was
Maltese: Anness II
English: Several sections of the summary of product characteristics were assessed and re worded.
Maltese: Diversi sezzjonijiet mis-sommarju tal-karatteristiċi tal-prodott kienu vvalutati u riformulati.
English: The mechanism of action of nicorandil as a nicotinamide ester was clarified and the wording harmonised.
Maltese: Il-mekkaniżmu ta' azzjoni ta' nicorandil bħala ester ta' nicotinamide kienet iċċarata u lformulazzjoni ġiet armonizzata.
English: The SG 002 study was an open label non-controlled study and EMD 034 study was a double-blind randomized cross over study.
Maltese: L-istudju SG 002 kien studju b'tikketta mikxufa mhux ikkontrollat u l-istudju EMD 034 kien studju doubleblind, randomizzat u crossover.
English: Section 4.4 - Special warnings and precautions for use Initially lack of glucose-6-phosphate-dehydrogenase was added as contraindication.
Maltese: Fil-bidu, in-nuqqas ta' glucose-6-phosphate-dehydrogenase ġie miżjud bħala kontraindikazzjoni.
English: Furthermore Japanese studies with double blind randomised controlled design have used higher single doses, i.e., 10 or 30 mg nicorandil.
Maltese: Ġappuniżi b'tfassil double blind, randomizzat u kkontrollat użaw dożi waħdiena ogħla, jiġifieri 10 jew 30 mg ta' nicorandil.
English: This section was clarified by indicating that the tablets should not be removed from the blister strip until intake (with cross references to the sections 4.4 and 6.4) as they are affected by humidity and mentioning of the absence of effect with food intake.
Maltese: Din is-sezzjoni kienet iċċarata bl-indikjazzjoni li l-pilloli ma għandhomx jitneħħew mill-istrixxa talfolja sakemm ma jittieħdu (b'referenzi inkroċjati għas-sezzjonijiet 4.4 u 6.4) peress li huma affettwati mill-umdità u r-referenza ta' nuqqas ta' effett mat-teħid tal-ikel.
English: However, two contraindications related to the risk of acute pulmonary oedema and hypovolemia were added in this section.
Maltese: Madankollu, ġew miżjuda żewġ kontradikazzjonijiet relatati mar-riskju ta' edema pulmonari akuta u ipovolimja f'din is-sezzjoni.
English: It possesses a potassium-channel opening effect.
Maltese: Għandu wkoll effett ta' ftuħ tal-kanal tal-potassju.
English: The main objective criterion of efficacy was exercise capacity reported in terms of time to onset of angina, total exercise duration and time to 1 mm ST segment depression.
Maltese: Il-kriterju oġġettiv ewlieni tal-effikaċja kienet il-kapaċità ta' eżerċizzju rrapportata f'termini ta' żmien għall-bidu ta' anġina, il-ħin totali tal-eżerċizzju u ż-żmien għal depressjoni tas-segment ST b'1 mm.
English: Overall summary of the scientific evaluation of Ikorel and associated names, and Dancor and associated names (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Ikorel u ismijiet assoċjati, u Dancor u ismijiet assoċjati (ara Anness I)
English: Due to its nitrate moiety, nicorandil relaxes also vascular smooth muscle, particularly in the venous system via an increase in intracellular cyclic guanosine monophosphate (GMP).
Maltese: Minħabba l-komponent ta' nitrat tiegħu, nicorandil jirrilassa wkoll l-muskoli lixxi tal-vini, b'mod partikolari fis-sistema venuża permezz ta' żieda fil-guanosine monophosphate (GMP) ċikliku intraċellulari.
English: Be careful to avoid nitrate tolerance (Class IIb, level of evidence C).
Maltese: Oqgħod attent li tevita t-tolleranza għan-nitrati (Klassi
English: Furthermore, the reduction of enddiastolic pressure and wall tension decreases the extravascular component of vascular resistance.
Maltese: Barra minn hekk, it-tnaqqis tal-pressjoni dijastolika aħħarija u t-tensjoni tal-ħitan tnaqqas il-komponent ekstravaskulari tarreżistenza vaskulari.
English: The Current Guidelines from the European Society of Cardiology (ESC) for the management of stable angina pectoris5 dated on 2013 provide the following recommendations for the use of nicorandil in pharmacological therapy to improve symptoms and/or reduce ischaemia in patients with stable angina:
Maltese: Il-Linji Gwida Attwali mis-Soċjetà Ewropea tal-Kardjoloġija (ESC) għall-ġestjoni ta' anġina pectoris stabbli5 iddatati 2013 jipprovdu r-rakkomandazzjonijiet li ġejjin għall-użu ta' nicorandil f'terapija farmakoloġika biex jittejbu s-sintomi u/jew titnaqqas l-iskemija f'pazjenti b'anġina stabbli:
English: Section 4.2 - Posology and Method of Administration
Maltese: Sezzjoni 4.2 - Pożoloġija u Metodu ta' Kif Għandu Jingħata
English: Furthermore, the secondary endpoint, the composite of cardiovascular death and MI, does not reach statistical significance and thus confirms the weakness and irrelevancy of the primary endpoint.
Maltese: Barra minn hekk, il-punt ta' tmiem sekondarju, il-kompost ta' mewt kardjovaskulari u MI, ma jilħaqx sinifikat statistiku u jikkonferma d-dgħjufija u l-irrilevanza tal-punt ta' tmiem primarju.
English: This activation of potassium channels induces vascular cell membrane hyperpolarisation with an arterial muscle relaxant effect, thereby leading to arterial dilatation and afterload reduction.
Maltese: Din l-attivazzjoni tal-kanali tal-potassju tinduċi iperpolarizzazzjoni tal-membrani taċ-ċelloli vaskulari b'effett rilassanti tal-muskoli arterjali, u b'hekk twassal għal twessigħ arterjali u tnaqqis fl-afterload.
English: Coronary heart disease (CHD) patients
Maltese: Pazjenti b'mard koronarju tal-qalb (CHD)
English: Due to the divergent national decisions taken by Member States (MS) concerning the authorisation of Ikorel and its associated names and Dancor and its associated names, these products were included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, requested by the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh).
Maltese: Minħabba deċiżjonijiet nazzjonali diverġenti meħuda mill-Istati Membri (SM) li jikkonċernaw lawtorizzazzjoni ta' Ikorel u ismijiet assoċjati tiegħu u Dancor u ismijiet assoċjati tiegħu, dawn ilprodotti kienu inklużi fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi talProdott (SmPC), mitluba mill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: This should reflect that nicorandil should be used with caution in patients with glucose-6-phosphate-dehydrogenase deficiency as this may lead to methemoglobinemia based on the theoretical mechanism of triggering this process by metabolism of organic nitrates resulting in the formation of nitrites.
Maltese: Dan għandu jirrifletti li nicorandil għandu jintuża b'attenzjoni f'pazjenti b'defiċjenza ta' glucose-6-phosphatedehydrogenase peress li dan jista' jwassal għal metemoglobinimja abbażi tal-mekkaniżmu teoretiku li jattiva dan il-proċess bil-metaboliżmu tan-nitrati organiċi li jirriżultaw fil-formazzjoni ta' nitrati.
English: While the IONA study does not provide adequate support for a prevention indication, the totality of the data, including IONA, provide good support for the new symptomatic indication proposed above.
Maltese: Filwaqt li l-istudju IONA ma jipprovdi ebda appoġġ xieraq għal indikazzjoni ta' prevenzjoni, id-dejta kollha, inkluż l-IONA, jipprovdu appoġġ tajjeb għall-indikazzjoni sintomatika ġdida proposta hawn fuq.
English: Am J Kidney Dis.
Maltese: Ma ġew introdotti l-ebda bidliet.
English: the CHMP was of the opinion that the benefit/risk ratio of Ikorel and associated names and Dancor and associated names is considered to be favourable.
Maltese: is-CHMP kien tal-opinjoni li l-proporzjon tal-benefiċċju/riskju ta' Ikorel u ismijiet assoċjati u Dancor u ismijiet assoċjati huwa kkunsidrat bħala favorevoli.
English: Further information on Neulasta 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: Other information about Neulasta
Maltese: Informazzjoni oħra dwar Neulasta
English: The active substance in Neulasta, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Neulasta, il-pegfilgrastim, hija magħmula minn filgrastim, li hija simili ħafna għal proteina tal-bniedem imsejħa fattur stimolanti tal-kolonja tal-granuloċiti (G-CSF).
English: Neulasta received a marketing authorisation valid throughout the EU on 22 August 2002.
Maltese: Neulasta ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-22 ta' Awwissu 2002.
English: What are the risks associated with Neulasta?
Maltese: X'inhuma r-riskji assoċjati ma' Neulasta?
English: As for all medicines, data on the use of Neulasta are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Neulasta hija ssorveljata kontinwament.
English: Why has Neulasta been approved?
Maltese: Għaliex Neulasta ġie approvat?
English: In Neulasta, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Neulasta, filgrastim ġie “pegilat” (twaħħal ma' kimika msejħa polietilenglikol).
English: Neulasta is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Maltese: Neulasta jingħata bħala doża waħda ta' 6 mg li tiġi injettata taħt il-ġilda mill-inqas 24 siegħa wara t-tmiem ta' kull ċiklu ta' kimoterapija (kura b'mediċini tal-kanċer).
English: Neulasta is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Maltese: Neulasta mhuwiex maħsub biex jintuża f'pazjenti bil-lewkimja majelojde kronika tal-kanċer tad-demm jew b'sindromi majelodisplastiċi (kundizzjonijiet li fihom jiġu prodotti għadd kbir ta' ċelloli tad-demm anormali, li jistgħu jiżviluppaw f'lewkimja).
English: Neulasta was as effective as filgrastim in reducing the duration of severe neutropenia.
Maltese: Neulasta kien effikaċi daqs filgrastim biex inaqqas it-tul ta' newtropenija severa.
English: This slows down the removal of filgrastim from the body, allowing the medicine to be given less often.
Maltese: Dan idewwem l-eliminazzjoni ta' filgrastim mill-ġisem, li jippermetti li l-mediċina tingħata inqas ta' spiss.
English: Neulasta has been studied in two main studies involving 467 patients with breast cancer who were being treated with chemotherapy.
Maltese: Neulasta ġie studjat f'żewġ studji ewlenin li involvew 467 pazjent b'kanċer tas-sider li kienu qegħdin jiġu kkurati b'kimoterapija.
English: Neulasta is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Maltese: Neulasta huwa mediċina li tintuża f'pazjenti bil-kanċer biex tgħin fin-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), li hija effett sekondarju komuni tal-kura tal-kanċer u tista' twassal biex il-pazjenti jsiru vulnerabbli għall-infezzjonijiet.
English: How is Neulasta used?
Maltese: Neulasta?
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (neutropenia accompanied by fever).
Maltese: Dan jingħata speċifikament biex jitnaqqas it-tul ta' żmien tan-newtropenija u biex tiġi evitata nnewtropenija bid-deni (newtropenija akkumpanjata minn deni).
English: How does Neulasta work?
Maltese: Kif jaħdem Neulasta?
English: Neulasta is effective at reducing the duration of severe neutropenia during chemotherapy and its side effects were considered manageable.
Maltese: Neulasta huwa effettiv biex inaqqas it-tul ta' żmien tan-newtropenija severa waqt il-kimoterapija u leffetti sekondarji tiegħu tqiesu ġestibbli.
English: For the full list of side effects and restrictions with Neulasta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet b'Neulasta, ara l-fuljett ta' tagħrif.
English: Side effects reported with Neulasta are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Neulasta huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The European Medicines Agency decided that Neulasta's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Neulasta huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: 56 hard capsules
Maltese: 56 kapsula iebsa
English: - Blisters (Al/PVC): 28, 56 and 112 hard capsules.
Maltese: - Folji (PVC/alu): 28, 56 u 112 kapsuli ibsin
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10 %).
Maltese: In vitro din is-sustanza li tifforma fil-metaboliżmu turi inibizzjoni minima għal acetylcholinesterase (<10%).
English: Date of latest renewal: 15 February 2016
Maltese: Data ta' l-aħħar tiġdid: 15 Frar 2016
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: Hard capsule (Capsule).
Maltese: Kapsula iebsa (Kapsula)
English: Frequency categories are defined 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: Kategoriji tal-frekwenza huma ddefiniti bl-użu talkonvenzjonijiet li ġejjin: 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-dejta disponibbli).
English: At least 4 points improvement on ADASCog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Maltese: * p<0.05, ** p<0.01, *** p<0.001
English: Capsule content: Magnesium stearate, colloidal anhydrous silica, hypromellose and microcrystalline cellulose.
Maltese: Il-kontenut tal-kapsula: Magnesium stearate, colloidal anhydrous silica, hypromellose u microcrystalline cellulose.
English: Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products metabolised by the following cytochromes isoemzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.
Maltese: Ibbażat fuq studji in vitro l-ebda interazzjoni farmakokinetika ma hija mistennija ma prodotti mediċinali metabolizzati mil-iżoenżimi tas-cytochromes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2CP, CYP2C8, CYP2C19, jew CYP2B6.
English: Rivastigmine Placebo Rivastigmine
Maltese: Plaċebo Rivastigmine
English: 112 hard capsules
Maltese: 112-il kapsula iebsa
English: Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g oxybutynin, tolterodine).
Maltese: Rivastigmine jista' jfixkel l-attività ta' prodotti mediċinali tat-tip antikolinerġiċi (eż. oxybutinin, tolterodine).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 June 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta‘ Ġunju 2011
English: Patients with mild dementia dementia (MMSE 10-17)
Maltese: Pazjenti b'dimenzja ħafifa moderata (MMSE 10-17)
English: ITT + RDO population (n=87)
Maltese: Popolazzjoni ITT + RDO (n=87)
English: Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules Red iron oxide (E172)
Maltese: Rivastigmine Actavis 3 mg, 4.5 mg u 6 mg kapsuli ibsin Red iron oxide (E172)
English: Specifar S.A 1, 28 Octovriou str. 123 51 Ag. Varvara Athens
Maltese: 1, 28 Triq Octovriou 123 51 Ag.
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Maltese: Il-metabolit ewlini NAP226-90 ukoll ma weriex potezjal ġenotossiku.
English: Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Maltese: Minħabba li il-bradikardija hija fattur ta' riskju għal tiġrib ta' torsades des pointes, l-użu ta' rivastigmine ma' prodotti li jinduċu it-tiġrib ta' torsades des pointes, bħal antipsikotiċi, i.e. uħud millphenothiazines (chlorpromazine, levopromazine), benzamides (sulpiride, sultopride, amisulpiride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine u moxifloxacine, għandu jiġi monitorat b'kawtela u monitoraġġ kliniku (ECG) jista' wkoll jiġi bżonnjuż.
English: Balance disorder Musculoskeletal stiffness Rigors
Maltese: Disturbi fl-ekwilibriju Riġidità muskolu-skeletrali Ebusija tal-ġisem
English: Maintenance dose
Maltese: Doża ta' Manteniment
English: These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7 % on rivastigmine vs. 0 % on placebo).
Maltese: Dawn il-każijiet wasslu għat-twaqqif ta' rivastigmine f'xi pazjenti (eż. twaqqif minħabba t-tregħid 1.7% fuq rivastigmine kontra 0% fuq plaċebo).
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonjiet avversi f'Tabella 1u Tabella 2 huma mniżżla skont is-sistema tal-klassifika tal-organi u l-kategorija tal-frekwenza f'MedDRA.
English: Adjusted treatment difference p-value versus placebo
Maltese: Differenza fil-kura aġġustata valur-p kontra l-plaċebo
English: PHARMACEUTICAL FORM AND CONTENTS 250 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 250 kapsuli iebsin
English: Gastrointestinal haemorrhage
Maltese: Emorraġiji gastro-intestinali
English: Atrial Fibrillation
Maltese: Fibrillazzjoni ta' l-atriju
English: Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
Maltese: Problemi fir-ritmu tat-taħbit tal-qalb (eż. bradikardija, imblukkar atrijuventrikulari, fibrillazzjoni ta' l-atrija u takikardija)
English: Parkinson's disease (worsening)
Maltese: Marda ta' Parkinson (aggravar)
English: NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis logo]
Maltese: FIS-SUQ [Actavis logo]
English: How to store Rivastigmine Actavis
Maltese: Tiħux Rivastigmine Actavis
English: Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules rivastigmine
Maltese: Rivastigmine Actavis 1.5 mg kapsuli ibsin Rivastigmine Actavis 3 mg kapsuli ibsin Rivastigmine Actavis 4.5 mg kapsuli ibsin Rivastigmine Actavis 6 mg kapsuli ibsin rivastigmine
English: INFORMATION IN BRAILLE Rivastigmine Actavis 1.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rivastigmine Actavis 1.5 mg
English: Allergic dermatitis (disseminated)
Maltese: Dermatite allerġika mifruxa
English: No adverse effects of rivastigmine were observed on fertility or reproductive performance in rats (see section 5.3).
Maltese: Ma ġew osservati l-ebda effetti avversi ta' rivastigmine fuq il-fertilita' u azzjoni riproduttiva fil-firien (ara sezzjoni 5.3).
English: Pruritus, allergic dermatitis (disseminated)
Maltese: Ħakk, Dermatite allerġika mifruxa
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with predefined 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'Rivastigmine 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: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38 %) and vomiting (23 %), especially during titration.
Maltese: Ir-reazzjonijiet avversi (ADRs) l-aktar komuni huma dawk fis-sistema gastro-intestinali, u dawn jikludu dardir (38 %) u rimettar (23 %), speċjalment waqt li tkun qed tiġi miżjuda d-doża.
English: Rivastigmine Actavis 1.5 mg hard capsules Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
Maltese: Rivastigmine Actavis 1.5 mg kapsuli ibsin Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
English: A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 non-smokers) following rivastigmine oral capsule doses of up to 12 mg/day.
Maltese: Analiżi farmakokinetika tal-popolazzjoni wriet li l-użu tan-nikotina iżżid ir rata ta' eliminazzjoni ta' rivastigmine mill-ħalq bi 23% f'pzjenti bil-marda ta' l-Alzheimer (n=75 ipejjpu u 549 ma jpejjpux) wara dożi ta' kapsuli mill-ħalq ta' rivastigmine, sa 12 mg/jum.
English: INFORMATION IN BRAILLE Rivastigmine Actavis 4.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rivastigmine Actavis 4.5 mg
English: Metabolism and nutrition disorders Common
Maltese: Disturbi fil-metaboliżmu u nutrizzjoni
English: Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Maltese: Trattament ta' sintomi ta' dimenzja ta' Alzheimer li jkunu ħfief għal moderatament sever.
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 10
Maltese: Rivastigmine ma kienx mutaġeniku f'ġabra ta' testijiet standard in vitro u in vivo, ħlief f'test ta' aberrazzjoni tal-kromosomi f'limfoċiti umani periferali meta ngħatat doża ta' 10
English: The active substance of Rivastigmine Actavis is rivastigmine.
Maltese: Is-sustanza attiva hija rivastigmine hydrogen tartrate.
English: Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules
Maltese: Rivastigmine Actavis 1.5 mg kapsuli ibsin Rivastigmine Actavis 3 mg kapsuli ibsin Rivastigmine Actavis 4.5 mg kapsuli ibsin Rivastigmine Actavis 6 mg kapsuli ibsin
English: INFORMATION IN BRAILLE Rivastigmine Actavis 6 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Rivastigmine Actavis 6 mg
English: In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures and respiratory arrest with possible fatal outcome.
Maltese: F'każijiet iktar severi, effetti nikotiniċi jistgħu jiżviluppaw bħal għejja muskulari, faxxikulazzjonijiet, aċċessjonijiet u arrest respiratorju b'riskju ta' fatalita.