FrancophonIA/ELRC3.0 huggingface dataset:
English: It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Maltese: (eż., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin u voriconazole) ma jistax jiġi evitat, għandu jkun hemm sorveljanza klinika tajba u jista' jkun hemm il-bżonn ta' aġġustament fid-doża ta' docetaxel waqt il-kura bl-inibitur qawwi ta' CYP3A4
English: • breast cancer.
Maltese: Disturbi respiratorji
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: Stomatite/mukożite ta' grad 4 L-ewwel episodju: waqqaf 5-FU biss, fil-korsijiet
English: Taxespira is used with prednisone or prednisolone (anti-inflammatory medicines);
Maltese: • 332 pazjent li ħadu docetaxel flimkien ma' prednisone jew prednisolone (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: The full EPAR and risk management plan summary for Taxespira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Taxespira is used with cisplatin and 5-fluorouracil (other cancer medicines);
Maltese: II), li ħadu docetaxel flimkien ma' cisplatin u 5-fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: • non-small-cell lung cancer.
Maltese: GĦAMLA FARMAĊEWTIKA
English: Other information about Taxespira
Maltese: Disturbi gastrointestinali
English: Taxespira contains the active substance docetaxel and is a ‘generic medicine'.
Maltese: Dawn ir-riżultati huma konsistenti mal-attività farmakoloġika ta' docetaxel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Taxespira, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Pazjenti li ħadu TAC, imqassma fi gruppi żgħar, skont fatturi pronostiċi maġġuri, definiti prospettivament, ġew analiżżati:
English: The company provided data from the published literature on docetaxel.
Maltese: Ir-reazzjonijiet avversi li jmissu huma ikkaġunati spiss b'docetaxel:
English: Taxespira is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Maltese: ma' dan il-prodott mediċinali (Taxespira 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni, li jkun fih biss kunjett wieħed).
English: The active substance docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Docetaxel jappartjeni għall-klassi ta' mediċini kontra l-kanċer li jissejħu taxoids.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects
Maltese: Docetaxel ma kellux effetti fuq ir-rabta ta' digitoxin mal-proteina.
English: Taxespira is used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Maltese: Docetaxel instab li huwa ċitotossiku in vitro għall-linji ċellulari ta' tumuri li huma derivati mill-ġrieden u lbniedem, u kontra ċelluli umani meħudin minn tumuri hekk kif dawn ikunu tneħħew, fi studji klonoġeniċi fil-laboratorju.
English: Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide.
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Hospira UK Limited on 28 August 2015.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Hospira UK Limited
English: Because Taxespira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Ma nstabux differenzi statistikament validi bejn iż-żewġ gruppi ta' trattament rigward il Kwalità talĦajja Globali.
English: For more information, see the summary of product characteristics.
Maltese: Ġew irrapportati każijiet ta' alopeċja persistenti.
English: Source: Study D2340-Table 11-6 and Table 11-7
Maltese: Sors: Studju D2340-Tabella 11-6 u Tabella 11-7
English: (E104) and purified water.
Maltese: (E104) u ilma purifikat.
English: CI - confidence interval.
Maltese: CI - intervall ta' kunfidenza.
English: Quinoline yellow WS dye (E104) Purified water
Maltese: Quinoline yellow WS dye E104
English: 250 hard capsules
Maltese: 250 kapsula iebsa
English: • Aggression
Maltese: • Aggressjoni
English: Alpha-tocopherol Silicone oil Dimethicone
Maltese: Matriċi li teħel Alpha-tocopherol Silicone oil Dimethicone
English: Prometax contains sodium benzoate
Maltese: Prometax fih sodium benzoate
English: Patients with clinically significant response (%)
Maltese: Pazjenti b'rispons klinikament rilevanti (%)
English: Also contains: sodium benzoate, citric acid, sodium citrate, quinoline yellow dye (E104) and purified water.
Maltese: Ikun fih ukoll, sodium benzoate, citric acid, sodium citrate, quinoline yellow dye (E104) u ilma purifikat.
English: Sick sinus syndrome
Maltese: Sindrome ta' sinus marid
English: Date of first authorisation: 04 December 1998 Date of latest renewal: 21 May 2008
Maltese: Data tal-aħħar tiġdid: 21 Mejju 2008
English: Atrial Fibrillation
Maltese: Fibrillazzjoni tal-atriju
English: Atrioventricular block, atrial fibrillation, tachycardia, sick sinus syndrome
Maltese: Imblokk atrijoventrikulari, fibrillazzjoni tal-atriju, takikardija, sindrome ta' sinus marid
English: Extrapyramidal symptoms
Maltese: Sintomi ekstrapiramidali
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: Baseline 264 34.4 268 34.9 DB-week 48 Value
Maltese: Linja bażi 264 34.4 268 34.9
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: PDS * p<0.05, ** p<0.01, *** p<0.001
English: ITT + RDO population (n=87)
Maltese: popolazzjoni ITT + RDO (n=87)
English: Oral solution Novartis Pharma GmbH Roonstraße 25
Maltese: Soluzzjoni orali Novartis Pharma GmbH Roonstraße 25
English: Gastric and duodenal ulcers
Maltese: Ulċeri gastriċi u duwodenali
English: 95% CI p-value
Maltese: 10 ċm2 n Medja n Medja DLSM 95% CI Valur p
English: Each bottle contains 250 capsules.
Maltese: Kull flixkun fih 250 kapsula.
English: The outer layer is beige and labelled with the following: - “Prometax”, “4.6 mg/24 h” and “AMCX”, - “Prometax”, “9.5 mg/24 h” and “BHDI”, - “Prometax”, “13.3 mg/24 h” and “CNFU”.
Maltese: barra huwa bex u ttikkettat b'dawn li jmiss: - “Prometax”, “4.6 mg/24 h” u “AMCX”, - “Prometax”, “9.5 mg/24 h” u “BHDI”, - “Prometax”, “13.3 mg/24 h” u “CNFU”.
English: What Prometax contains - The active substance is rivastigmine hydrogen tartrate.
Maltese: X'fih Prometax - Is-sustanza attiva hija rivastigmine hydrogen tartrate.
English: A relationship between active substance exposure at steady state (rivastigmine and metabolite NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
Maltese: Relazzjoni bejn l-esponiment għas-sustanza attiva fi stat fiss (rivastigmine u l-metabolu NAP226-90) u l-piż tal-ġisem deher f'pazjenti bid-dimenzja ta' Alzheimer.
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jista' jaffettwa sa persuna waħda minn kull 1,000)
English: ITT + RDO population (n=107)
Maltese: Popolazzjoni ITT + RDO (n=107)
English: Atrioventricular block
Maltese: Imblokk atrijuventrikulari
English: Prometax 2 mg/ml [folding box only]
Maltese: Prometax 2 mg/ml [kaxxa li tintlewa biss]
English: • Hyperactivity (high level of activity, restlessness)
Maltese: • Attività eċċessiva (livell għoli ta' attività, nuqqas ta' kwiet)
English: ITT + RDO population (n=329)
Maltese: Popolazzjoni ITT + RDO (n=329)
English: Prometax capsules 12 mg/day
Maltese: Prometax kapsuli 12 mg/jum
English: Parkinson gait
Maltese: Parkinson fil-mixi
English: Prometax 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: Prometax 2 mg/ml oral solution
Maltese: Prometax 2 mg/ml soluzzjoni orali
English: Prometax 2 mg/ml oral solution rivastigmine
Maltese: Prometax 2 mg/ml soluzzjoni orali rivastigmine
English: Gastrointestinal haemorrhage
Maltese: Emorraġiji gastrointestinali
English: Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with Prometax capsules.
Maltese: Tabella 2 turi reazzjonijiet avversi rrappurtati waqt studji kliniċi mwettqa f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson ikkurati bil-kapsuli Prometax.
English: Also contains: polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymercoated.
Maltese: Fiha wkoll: rita ta' polyethylene terephthalate bil-lakka, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, żejt tas-silicone, dimethicone, rita tal-polyester miksija bi fluoropolymer.
English: Psychomotor hyperactivity
Maltese: Attività psikomotorili eċċessiva
English: Rivastigmine in vivo release rates per 24 h
Maltese: Rata ta' ħelsien ta' Rivastigmine in vivo kull 24 siegħa
English: The active substance of Prometax is rivastigmine.
Maltese: PrometaxIs-sustanza attiva f'Prometax hija rivastigmine.
English: Rivastigmine may exacerbate or induce extrapyramidal symptoms.
Maltese: Rivastigmine jista' jaggrava jew jikkawża sintomi ekstrapiramidali.
English: Urinary incontinence General disorders and administration site conditions Common
Maltese: Inkontinenza urinarja Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni
English: Prometax 1.5 mg hard capsules Prometax 3.0 mg hard capsules Prometax 4.5 mg hard capsules Prometax 6.0 mg hard capsules
Maltese: Prometax 1.5 mg kapsuli ibsin Prometax 3.0 mg kapsuli ibsin Prometax 4.5 mg kapsuli ibsin Prometax 6.0 mg kapsuli ibsin
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 tal-atrija u takikardija)
English: Movement disorder Bradykinesia
Maltese: Disturbi fil-moviment Bradikajneżja
English: Adjusted treatment difference n/a p-value versus placebo
Maltese: Differenza fil-kura aġġustata n/a valur-p kontra l-plaċebo
English: Prometax 1.5 mg hard capsules Prometax 3.0 mg hard capsules Prometax 4.5 mg hard capsules Prometax 6.0 mg hard capsules rivastigmine
Maltese: Prometax 1.5 mg kapsuli ibsin Prometax 3.0 mg kapsuli ibsin Prometax 4.5 mg kapsuli ibsin Prometax 6.0 mg kapsuli ibsin rivastigmine
English: Baseline 265 27.5 271 25.8 Week 48 Value
Maltese: Linja bażi 265 27.5 271 25.
English: ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Prometax 15 cm as compared to Prometax 10 cm
Maltese: Punteġġi ADAS-cog: Differenza negattiva fid-DLSM tindika titjib akbar f'Prometax 15 ċm meta mqabbel ma' Prometax 10 ċm Punteġġi ADCS-IADL:
English: Polyethylene terephthalate film, lacquered
Maltese: Rita tal-polyethylene terephthalate, bil-lakka
English: Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine.
Maltese: U KWANTITATTIVA Kull ml fih rivastigmine hydrogen tartrate li jikkorrispondi għal 2 mg rivastigmine.
English: Headache, syncope, dizziness
Maltese: Uġigħ ta' ras, sinkope, sturdament
English: ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
Maltese: CIBIC-Plus: titjib PDS: titjib ta' mill-anqas 10%
English: Pruritus, erythema, urticaria, vesicles, allergic dermatitis (disseminated) Renal and urinary disorders Common
Maltese: Ħakk, eritema, urtikarja, infafet, dermatite allerġika (mifruxa)
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 Prometaxwara d-data ta' meta tiskadi li tidher fuq il-kartuna war JIS/EXP.
English: One of the inactive ingredients in Prometax oral solution is sodium benzoate.
Maltese: Waħda mis-sustanżi mhux attivi ta' Prometax soluzzjoni orali hija sodium benzoate.
English: Each Prometax 1.5 mg capsule contains 1.5 mg of rivastigmine.
Maltese: Kull kapsula Prometax ta' 1.5 mg fiha 1.5 mg rivastigmine.
English: Urinary tract infection Metabolism and nutrition disorders Common
Maltese: Infezzjoni fis-sistema tal-awrina Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: - The other ingredients are polyethylene terephthalate film lacquered, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, silicone oil, dimethicone, polyester film fluoropolymer-coated.
Maltese: - Is-sustanzi l-oħra huma rita ta' polyethylene terephthalate bil-lakka, alpha-tocopherol, poly(butylmethacrylate, methylmethacrylate), acrylic copolymer, żejt tas-silicone, dimethicone, rita ta' polyester miksi bi fluoropolymer.
English: The outside of the backing layer is beige and labelled with “Prometax”, “4.6 mg/24 h” and “AMCX”.
Maltese: In-naħa ta' barra tas-saff ta' wara huwa bex u tikkettat b'“Prometax”, “4.6 mg/24 h” u “AMCX”.
English: They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.
Maltese: Ippakkjati f'folji li jiġu fi tliet daqsijiet (28, 56 jew 112-il kapsula) u fliexken tal-plastik ta' 250 kapsula, iżda jista' jkun li dawn ma ssibhomx f'pajjiżek.
English: PC: [folding box only] SN: [folding box only] NN: [folding box only]
Maltese: [kaxxa li tintlewa biss] NN: [kaxxa li tintlewa biss]
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 gastrointestinali, u dawn jikludu dardir (38%) u rimettar (23%), speċjalment waqt li tkun qed tiġi miżjuda d-doża.
English: Total plasma clearance of rivastigmine was approximately 130 litres/h after a 0.2 mg intravenous dose and decreased to 70 litres/h after a 2.7 mg intravenous dose, which is consistent with the non-linear, over-proportional pharmacokinetics of rivastigmine due to saturation of its elimination.
Maltese: Wara doża minn ġol-vina ta' 0.2 mg it-tneħħija totali mill-plażma ta' rivastigmine kienet ta' bejn wieħed u ieħor 130 litru/siegħa, u din naqset għal 70 litru/siegħa wara doża minn ġol-vini ta' 2.7 mg, li taqbel ma' farmakokinetika sproporzjonali, mhux linejari ta' rivastigmine minħabba li leliminazzjoni tiegħu tkun saturata.
English: Following a single 3 mg or 6 mg oral dose, the mean oral clearance of rivastigmine was approximately 46-63% lower in patients with mild to moderate hepatic impairment (n=10, Child-Pugh score 5-12, biopsy proven) than in healthy subjects (n=10).
Maltese: Wara doża orali waħda ta' 3 mg jew 6 mg, it-tneħħija orali medja ta' rivastigmine kienet madwar 46-63% inqas f'pazjenti b'indeboliment epatiku ħafif sa moderat (n=10, punteġġ ChildPugh 5-12, bijopsija ppruvata) milli f'individwi f'saħħithom (n=10).
English: Each ml contains 2 mg rivastigmine present as rivastigmine hydrogen tartrate.
Maltese: Kull ml fih 2 mg rivastigmine bħala rivastigmine hydrogen tartrate.
English: • Urinary incontinence (inability to retain adequate urine)
Maltese: • Inkontinenza urinarja (nuqqas ta' kapaċità li żżomm l-awrina b'mod adegwat)
English: Prometax 15 cm2
Maltese: Prometax 15 ċm2
English: Each Prometax 6.0 mg capsule contains 6.0 mg of rivastigmine.
Maltese: Kull kapsula Prometax ta' 6.0 mg fiha 6.0 mg rivastigmine.
English: n Mean n Mean DLS M
Maltese: U MNEJN GĦANDU JINGĦATA
English: • Anxiety
Maltese: • Anzjetà
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase
Maltese: In vitro din is-sustanza li tifforma fil-metaboliżmu turi inibizzjoni minima għal acetylcholinesterase (<10%).
English: Each Prometax 4.5 mg capsule contains 4.5 mg of rivastigmine.
Maltese: Kull kapsula Prometax ta' 4.5 mg fiha 4.5 mg rivastigmine.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 6.0 mg rivastigmine.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 1.5 mg rivastigmine.
English: The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Maltese: L-effikaċja ta' rivastigmine f'dimenzja assoċjata mal-marda ta' Parkinson intweriet fi studju ċentrali ta' 24-ġimgħa multiċentriku, double-blind, kontrollat bil-plaċebo u bil-fażi tal-estenzjoni tiegħu ta' 24ġimgħa open-label.
English: It readily crosses the blood-brain barrier and has an apparent volume of distribution in the range of 1.8-2.7 l/kg.
Maltese: Huwa jaqsam malajr il-barriera ta' bejn il-moħħ u d-demm u għandu volum apparenti ta' distribuzzjoni b'medda ta' bejn 1.8-2.7 l/kg.
English: The oral solution is packaged with an oral dosing syringe in a plastic tube container.
Maltese: Is-soluzzjoni orali hija ppakkjata flimkien ma' siringa orali, f'kontenitur f'forma ta' tubu tal-plastik.
English: Application site skin reactions (e.g. application site erythema*, application site pruritus*, application site oedema*, application site dermatitis, application site irritation), asthenic conditions (e.g. fatigue, asthenia), pyrexia, weight decreased
Maltese: Reazzjonijiet tal-ġilda mnejn tiġi applikata (eż. ħmura fejn tiġi applikata*, ħakk fejn tiġi applikata*, edema fejn tiġi applikata*, dermatite fejn tiġi applikata, irritazzjoni fejn tiġi applikata), kundizzjonijiet asteniċi (eż. għeja, astenja), deni, telf tal-piż
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Prometax 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'Prometax 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: Multipack: 60 (2 packs of 30) transdermal patches Multipack: 90 (3 packs of 30) transdermal patches
Maltese: Pakkett b'ħafna: 90 (3 pakketti ta' 30) garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda.
English: In other cases, Prometax has been discontinued (see section 4.8).
Maltese: F'każijiet oħra, Prometax ġie mwaqqaf (ara sezzjoni 4.8).
English: Prometax 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: Nervous system disorders Common
Maltese: Disturbi fis-sistema nervuża Komuni ħafna
English: Prometax can be used with food, drink and alcohol.
Maltese: Prometax jista' jintuża mal-ikel, ix-xorb u l-alkoħol.
English: organizačná zložka Tel: + 421 2 4820 0600
Maltese: Slovenská republika Sandoz d.d. organizačná zložka Tel: + 421 2 4820 0600
English: There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
Maltese: M'hemmx użu relevanti ta' Prometax fil-popolazzjoni pedjatrika għat-trattament tal-marda ta' Alzheimer.
English: The outside of the backing layer is beige and labelled with “Prometax”, “13.3 mg/24 h” and “CNFU”.
Maltese: In-naħa ta' barra tas-saff ta' wara huwa bex u tikkettat b'“Prometax”, “13.3 mg/24 h” u “ CNFU”.
English: The following adverse reactions have only been observed with Prometax capsules and oral solution and not in clinical studies with Prometax 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 Prometax 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: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorrispondi għal 4.5 mg rivastigmine.
English: - Prometax 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 “ENA 713 4,5 mg” on the body.
Maltese: - Prometax 4.5 mg kapsuli ibsin, li fihom trab offwajt jagħti ħarira fl-isfar, għandhom għatu aħmar u korp aħmar, b'timbru aħmar “ENA 713 4,5 mg” fuq il-korp.
English: Prometax 6.0 mg hard capsules rivastigmine
Maltese: Prometax 6.0 mg kapsuli ibsin rivastigmine
English: Concomitant administration of rivastigmine with commonly prescribed medicinal products, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, calcium channel blockers, inotropic agents, antianginals, non-steroidal anti-inflammatory agents, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects.
Maltese: L-għotja fl-istess ħin ta' rivastigmine ma' prodotti mediċinali li jiġu ordnati ta' spiss, bħal antaċidi, antiemetiċi, antidijabetiċi, mediċini tal-pressjoni li jaħdmu b'mod ċentrali, imblukkaturi tal-kanali talcalcium, sustanzi inotropiċi, mediċini għall-anġina, aġenti mhux setrojdali kontra l-infjammazzjoni, estroġeni, analġesiċi, benzodiażepini u antiistaminiċi, ma kinetx assoċjata ma' tibdil fil-kinetika ta' rivastigmine jew żieda fir-riskju ta' effetti ħżiena klinikament rilevanti.
English: times the foreseen clinical exposure.
Maltese: darbiet lesponiment kliniku mbassar.
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 for up to 12 mg/day.
Maltese: Analiżi farmakokinetika tal-popolazzjoni wriet li l-użu tan-nikotina jżid it-tneħħija orali ta' rivastigmine bi 23% f'pazjenti bil-marda ta' Alzheimer (n=75 li jpejpu u 549 li ma jpejpux) wara dożi sa 12-il mg/jum f'forma ta' kapsula orali ta' rivastigmine.