FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Maltese: B'mod konformi ma' l-effetti magħrufin ta' sildenafil fuq in-nitric oxide/cGMP pathway (ara sezzjoni 5.1), intwera li sildenafil iżid l-effett tan-nitrati li jnaqqsu l-pressjoni, u għaldaqstant il-koamministrazzjoni ta' sildenafil u donaturi ta' nitric oxide jew nitrati hija kontraindikata (ara sezzjoni
English: Healthy, elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Maltese: Voluntiera anzjani b'saħħithom (65 sena jew iżjed) kellhom tneħħija mnaqqsa ta' sildenafil, li jirriżulta f'bejn wieħed u ieħor 90% konċentrazzjonijiet ogħla fil-plażma ta' sildenafil u l-metabolu attiv N-desmethly mqabbel ma' dawk li nstabu f'voluntiera żagħżagħ b'saħħithom (18-45 sena).
English: This leaflet was last revised in {MM/YYYY}.
Maltese: DATA TA' TA' REVIŻJONI TAT-TEST
English: VIAGRA 100 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets
Maltese: Folji ta' l-aluminju/PVC f'pakketti ta' 2, 4, 8, 12 jew 24-il pillola.
English: Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Maltese: Użu f'pazjenti li jkunu qed jieħdu prodotti mediċinali oħra Bl-eċċezzjoni ta' ritonavir li miegħu ma jaqbilx li jingħata sildenafil (ara sezzjoni 4.4) doża tal-bidu ta' 25 mg għandha tiġi kkunsidrata f'pazjenti li fl-istess ħin ikunu fuq kura ta' inibituri ta' CYP3A4
English: Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil
Maltese: Kull pillola fiha sildenafil citrate ekwivalenti għal 50 mg ta' sildenafil
English: Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Maltese: Uroloġiċi; Pilloli użati għal problema ta' l-erezzjoni tal-pene.
English: If VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Maltese: Jekk VIAGRA tittieħed ma' l-ikel, jista' jdum aktar biex jibda jaħdem meta mqabbel ma' meta jittieħed fuq stonku vojt (ara sezzjoni 5.2).
English: They are marked “PFIZER” on one side and “VGR 25” on the other side.
Maltese: Huma mmarkati bil-kelma “PFIZER” fuq naħa waħda u b'“VGR 25” fuq in-naħa l-oħra.
English: VIAGRA will only help you to get an erection if you are sexually stimulated.
Maltese: VIAGRA tgħinek biss biex ikollok erezzjoni jekk inti tkun stimulat sesswalment.
English: This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots).
Maltese: Din il-mediċina tintuża għat-trattament tal-ipertensjoni arterjali pulmonarja(i.e., pressjoni għolja tad-demm fil-pulmuni)u ipertensjoni pulmonarja tromboembolika kronika(i.e., pressjoni għolja tad-demm fil-pulmuni kkawżata minnċapep fiddemm).
English: Batch
Maltese: Truxija
English: Throat tightness, Nasal oedema, Nasal dryness
Maltese: Tqala, treddigħ u fertilità
English: Each tablet contains 25 mg of sildenafil (as the citrate salt).
Maltese: Kull pillola li tinħall fil-ħalq fiha 25mg ta' sildenafil (bħala citrate salt).
English: EU/1/98/077/014 (2 film-coated tablets) EU/1/98/077/006 (4 film-coated tablets) EU/1/98/077/007 (8 film-coated tablets) EU/1/98/077/008 (12 film-coated tablets) EU/1/98/077/024 (24 film-coated tablets)
Maltese: (2 pilloli miksijin b'rita) EU/1/98/077/006 (4 pilloli miksijin b'rita) EU/1/98/077/007 (8 pilloli miksijin b'rita) EU/1/98/077/008 (12-il pillola miksijin b'rita) EU/1/98/077/024 (24 pillola miksijin b'rita)
English: If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Maltese: Jekk inti għandek ċertu mard rari ereditarju tal-għajnejn (bħal retinitis pigmentosa).
English: Based on efficacy and tolerability the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Maltese: Bażata fuq effiċjenza u tollerabilità, id-doża tista' tiżdied f'inkrementi għal 50 mg sa 100 mg skont il-ħtieġa.
English: Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Maltese: Rari (jistgħu jaffettwaw sa 1 persuna minn kull 1,000): ħass ħażin, puplesija, attakk tal-qalb, taħbit irregolari tal-qalb, fluss tad-demm temporanjament imnaqqas għal partijiet tal-moħħ, sensazzjoni ta' ssikkar tal-gerżuma, telf ta' sensazzjoni fil-ħalq, fsada fuq wara tal-għajnejn, tara doppju, tnaqqis filpreċiżjoni viżiva, sensazzjoni mhux normali fl-għajnejn, nefħa tal-għajn jew tal-kappell tal-għajn, telf ta' kulur tal-abjad tal-għajnejn, fsada fil-pene, preżenza ta' demm fis-semen, imnieħer xott, nefħa fuq ġewwa tal-imnieħer, tħossok irritabbli u telf f'daqqa tas-smigħ.
English: In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Maltese: Fi studju speċifiku ta' interazzjoni, fejn sildenafil (100 mg) kien ko-amministrat ma' amlodipine f'pazjenti bi pressjoni għolja, kien hemm aktar tnaqqis ta' 8 mmHg fil-pressjoni sistolika tad-demm f'pożizzjoni mimduda.
English: EU/1/98/077/020 (2 orodispersible tablets) EU/1/98/077/021 (4 orodispersible tablets) EU/1/98/077/022 (8 orodispersible tablets) EU/1/98/077/023 (12 orodispersible tablets)
Maltese: EU/1/98/077/020 (2 pilloli li jinħallu fil-ħalq) EU/1/98/077/021 (4 pilloli li jinħallu fil-ħalq) EU/1/98/077/022 (8 pilloli li jinħallu fil-ħalq) EU/1/98/077/023 (12-il pillola li jinħallu fil-ħalq)
English: Penile haemorrhage, Priapism*,
Maltese: Pressjoni għolja, pressjoni baxxa
English: VIAGRA 25 mg film-coated tablets Sildenafil
Maltese: VIAGRA 50 mg pilloli li jinħallu fil-ħalq Sildenafil
English: Upjohn Hellas Ε.Π.Ε., Τηλ.
Maltese: Għafis fuq il-gerżuma, Edema nażali, Imnieħer xott
English: VIAGRA 25 mg tablets Sildenafil
Maltese: VIAGRA 25 mg pilloli miksija b'rita Sildenafil
English: Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Maltese: Studji in vitro wrew li sildenafil huwa selettiv għal PDE5, li huwa nvolut fil-proċess ta' l-erezzjoni.
English: Cerebrovascular accident, Transient ischaemic attack, Seizure*, Seizure recurrence,* Syncope
Maltese: Ngħas tqil, Ipostesja Aċċident ċerebrovaskulari, Attakk iskemiku temporanju, Attakk ta' puplesija*, Attakki ripetuti ta' puplesija*, Sinkope
English: Ear and labyrinth disorders
Maltese: Disturbi filwidnejn u fis-sistema labirintika
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Maltese: Komuni (jistgħu jaffettwaw sa persuna minn kull 10): dardir, ħmura fil-wiċċ, fwawar tal-menopawsa (sintomi jinkludu sensazzjoni f'daqqa ta' sħana fil-parti ta' fuq tal-ġisem), indiġestjoni, vista mżewwqa b'xi kulur, vista mċajpra, disturb viżiv,imnifsejn miżduda u sturdament.
English: VIAGRA 50 mg orodispersible tablets
Maltese: VIAGRA 50 mg pilloli miksija b'rita
English: Stevens-Johnson
Maltese: Investigazz jonijiet
English: • Chest pains - this occurs uncommonly If this occurs during or after intercourse - Get in a semi-sitting position and try to relax.
Maltese: • Uġigħ fis-sider - dan iseħħ b'mod mhux komuni Jekk dan iseħħ matul jew wara l-att sesswali:
English: The recommended starting dose is 50 mg.
Maltese: Id-doża tal-bidu rakkomandata hija 50 mg.
English: EU Number Invented Name Strength Pharmaceutical Form
Maltese: Numru tal-UE Isem talProdott
English: Content Package size Withdrawal period
Maltese: Kontenut Daqs ta' lIppakkjar
English: London, 22 March 2007 Doc.
Maltese: Londra, 22 ta' Marzu 2007 Dok. Ref.
English: Ref. EMEA/117441/2007
Maltese: EMEA/44528/2008
English: International non-proprietary name (INN): ruboxistaurin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): ruboxistaurin
English: The active substance in ARXXANT, ruboxistaurin, blocks the activity of the enzyme protein kinase C (PKC) beta.
Maltese: Is-sustanza attiva f'ARXXANT, ruboxistaurin, timblokka l-attività ta' l-enzima protein kinase C (PKC) beta.
English: ARXXANT is a medicine that contains the active substance ruboxistaurin (as 32 mg tablets).
Maltese: ARXXANT huwa mediċina li fiha s-sustanza attiva ruboxistaurin (bħala pilloli ta' 32 mg).
English: What is ARXXANT?
Maltese: X'inhu ARXXANT?
English: On 13 March 2007, Eli Lilly Nederland B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for ARXXANT, for the treatment of diabetic retinopathy in adult patients with moderate to severe non-proliferative retinopathy.
Maltese: Fit-13 ta' Marzu 2007, Eli Lilly Nederland B.V. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal ARXXANT, għat-trattament ta' retinopatija djabetika f'pazjenti adulti b'retinopatija mhux proliferattiva minn moderata għal severa.
English: The company presented the results of one main study involving 685 patients with moderately severe to very severe non-proliferative diabetic retinopathy.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni li involva 685 pazjent b'retinopatija dijabetika mhux proliferattiva minn moderatament severa għal severa ħafna.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: IsCHMP normalment jieħu sa 210 ġranet sabiex jevalwa applikazzjoni ġdida.
English: What was ARXXANT expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża ARXXANT?
English: This was assessed by measuring the number of letters they could see on a standard vision chart: a fall of 15 letters or more over six months was considered to be a loss of vision.
Maltese: Dan kien stmat billi ġie mkejjel in-numru ta' ittri li setgħu jaraw fuq tabella tal-vista standard: tnaqqis ta' 15-il ittra jew aktar fuq sitt xhur kienet ikkunsidrata bħala telf fil-vista.
English: How is ARXXANT expected to work?
Maltese: Kif huwa mistenni li jaħdem ARXXANT?
English: By blocking PKC beta, ruboxistaurin is expected to prevent damage to the blood vessels and loss of vision.
Maltese: Billi jimblokka PKC beta, ruboxistaurin huwa mistenni li jimpedixxi ħsara lill-vażi tad-demm u telf fil-vista.
English: ARXXANT was expected to be used to treat adult patients who have moderate to severe non-proliferative retinopathy as a complication of diabetes.
Maltese: ARXXANT kien mistenni li jintuża biex jittratta pazjenti adulti li għandhom retinopatija mhux proliferattiva minn moderata għal severa bħala kumplikazzjoni tad-dijabete.
English: The CHMP was concerned that the effectiveness of ARXXANT had not been proven adequately in the clinical study.
Maltese: Is-CHMP kien imħasseb fuq il-fatt li l-effikaċja ta' ARXXANT ma kinitx ipprovata b'mod adegwat flistudju kliniku.
English: The effects of ARXXANT were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' ARXXANT ġew l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that ARXXANT could not have been approved for the treatment of diabetic retinopathy in adult patients with moderate to severe non-proliferative retinopathy.
Maltese: Abbażi ta' l-analiżi tad-dejta fi żmien l-irtirar, is-CHMP wera xi tħassib u kien ta' l-opinjoni provviżorja li ARXXANT ma setax jiġi approvat għat-trattament ta' retinopatija djabetika f'pazjenti adulti b'retinopatija mhux proliferattiva minn moderata sa severa.
English: This is a naturally-occurring enzyme that is responsible for regulating the activity of blood vessels in the retina.
Maltese: Din hija enzima li hija preżenti b'mod naturali u li hija responsabbli biex tirregola lattività tal-vażi tad-demm fir-retina.
English: 49 x 1 tablets (unit dose)
Maltese: 49 x 1 pillola (doża waħda)
English: 84 (4 x 21) tablets (multipack)
Maltese: 84 (4 x 21) pilloli (pakkett multiplu)
English: Film-coated tablet Oral use blister (PVC/PE/PCTFE/alu)
Maltese: 100 mg / 40 mg pilloli miksija b'rita Użu orali folja (PVC/PE/PCTFE/alu)
English: p value 95 % CI
Maltese: Valur p 95% CI
English: (see sections 4.4 and 4.8).
Maltese: (ara sezzjoni 4.8)
English: Rīga LV‐1004
Maltese: LV‐1004
English: Adverse Events
Maltese: Eventi avversi
English: 35-959 Rzeszów Poland
Maltese: 35-959 Rzeszow Il-Polonja
English: Tolcapon e N=75
Maltese: Tolcapone N=75
English: Increase of alanine aminotransferase (ALT)
Maltese: Żieda ta' alanine aminotransferase (ALT)
English: Increase of alanine aminotransferase
Maltese: Żieda ta' alanine aminotransferase
English: Pharmaco-therapeutic group: Anti-Parkinson drugs, other dopaminergic agents, ATC code: NO4BX01
Maltese: Mediċina Anti-Parkinson, aġenti dopaminerġiċi Kodiċi ATC: NO4BX01
English: Yellow iron oxide Ethylcellulose
Maltese: Yellow iron oxide (E 172) Ethylcellulose
English: Rare (≥1/10,000 to < 1/1,000)
Maltese: Rari (>1/10,000 > 1/1,000)
English: Meda AB Pipers väg 2A S-170 09 Solna Sweden
Maltese: Meda AB Pipers väg 2A S-170 09 Solna L-Isvezja
English: System organ class
Maltese: Sistema tal-Klassifika ta' lOrgani
English: Hydroxypropylmethylcellulose, Talc
Maltese: Methylhydroxypropylcellulose, Talc
English: Alfred Gera & Sons Ltd. 10, Triq il-Masġar Qormi QRM 3217
Maltese: 10, Triq il-Masġar Qormi QRM 3217
English: Meda Pharma SIA 101 Mūkusalas str.
Maltese: SIA 101 Mūkusalas str.
English: While receiving treatment:
Maltese: Jekk it-trattament jitwaqqaf:
English: Vomiting Constipation Xerostomia Abdominal pain Dyspepsia
Maltese: Remettar Kostipazzjoni Xerostomija Uġigħ abdominali Dispepsija
English: Catechols and other drugs metabolised by catechol-O-methyltransferase (COMT): Tolcapone may influence the pharmacokinetics of drugs metabolised by COMT.
Maltese: Catechols u mediċini oħra metabolizzati bil-catechol-O-methyltransferase (COMT): Tolcapone jista' jinfluwenza l-farmakokinetiċi ta' mediċini metabolizzati bil-COMT.
English: Pharmacodynamic effects
Maltese: Effetti farmakodinamiċi:
English: Calcium hydrogen phosphate Microcrystalline cellulose Povidone K30
Maltese: Calcium hydrogen phosphate (anhydrous) Microcrystalline cellulose Povidone K30
English: The absolute bioavailability of an oral administration is around 65 %.
Maltese: Il-biodisponibilità ta' amministrazzjoni orali hija ta' madwar 65%.
English: Neuroleptic Malignant Syndrome (NMS):
Maltese: Sindromu Malinn Newroleptiku (NMS):
English: ICN Polfa Rzeszów S.A. ul.
Maltese: ICN Polfa Rzeszow S.A. Ul. Przemyslowa 2
English: Outer Carton and bottle label, 30, 60, 100, 200 film-coated tablets
Maltese: Kartuna ta' Barra u tikketta tal-flixkun, 30, 60, 100, 200
English: 1 Primary and Secondary Outcome of double-blind Trial Entacapone
Maltese: 1 Riżultat Prinċipali u Riżultat Sekondarju ta' Prova double-blind
English: Tolcapone does not distribute widely into tissues due to its high plasma protein binding (>99.9 %).
Maltese: Tolcapone ma jiġix distribwit ħafna fit-tessut minħabba l-irbit mal-proteini tal-plażma għoli tiegħu (>99.9%).
English: “TASMAR” and “200” are engraved on one side.
Maltese: “TASMAR” u “200” huma mnaqqxa fuq naħa waħda.
English: Sodium starch glycollate Lactose
Maltese: Sodium starch glycollate Lactose monohydrate Talc
English: Titanium dioxide Triacetin
Maltese: Titanium dioxide (E 171) Triacetin
English: A natural protein (enzyme) in your body, the (COMT) Catechol-O-methyltransferase breaks down the levodopa.
Maltese: Proteina naturali (enzima) f'ġismek, (COMT) Catechol-O-methyltransferase tkisser levodopa.
English: C/Plom, 2-4, 5ª planta 08038 - Barcelona Tel: +34 900 102 712
Maltese: Mylan Pharmaceuticals S.L. C/Plom, 2-4, 5ª planta 08038 - Barcelona Tel: +34 900 102 712
English: Number (proportion) with ≥1 hour ON time response 32 (43 %) 40 (53 %) p=0.191 -5.2;26.6 Secondary Outcome
Maltese: Numru (proporzjon) b' ≥1 siegħa ta' rispons f'ħin ON 32 (43 %) 40 (53 %) p=0.191 -5.
English: EU/1/97/044/006 100 tablets
Maltese: EU/1/97/044/006 100 pillola
English: Tablet core: Calcium hydrogen phosphate, Microcrystalline cellulose, Povidone K30, Sodium starch glycollate, Lactose, Talc, Magnesium stearate.
Maltese: Calcium hydrogen phosphate (anhydrous), Microcrystalline cellulose, Povidone K30, Sodium starch glycollate, Lactose monohydrate, Talc, Magnesium stearate.
English: The peak plasma concentrations of tolcapone at this dose were on average 30 µg/ml (compared to 3 and 6 µg/ml with 100 mg tid and 200 mg tid of tolcapone respectively).
Maltese: L-ogħla konċentrazzjonijiet ta' plażma ta' tolcapone b'din id-doża kienu medja ta' 30 µg/ml (ikkumparati ma' 3 u 6 µg/ml b'100 mg tid u 200 mg tid ta' tolcapone rispettivament).
English: Tolcapone is an orally active, selective and reversible catechol-O-methyltransferase (COMT) inhibitor.
Maltese: Tolcapone huwa inibitur catechol-O-methyltransferase (COMT) oralment attiv, selettiv u riversibbli.
English: After oral administration, 60 % of drug-related material is excreted into urine and 40 % into faeces.
Maltese: Wara l-amministrazzjoni orali, 60% tal-materjal relatat mal-mediċina joħroġ ma' l-urina u 40% ma' l-ippurgar.
English: Film-coat: Hydroxypropylmethylcellulose, Talc, Yellow iron oxide, Ethylcellulose, Titanium dioxide, Triacetin, Sodium lauril sulfate.
Maltese: Kisja b'rita: Methylhydroxypropylcellulose, Talc, Iron oxide isfar (E 172), Ethylcellulose, Titanium dioxide (E 171), Triacetin, Sodium lauril sulfate.
English: The frequency of possible side effects listed below is defined using the following convention:
Maltese: Il-frekwenza tal-effetti sekondarji possibbli elenkati taħt hija definita bl-użu tal-konvenzjoni li ġejja:
English: Administered concomitantly with levodopa and an aromatic amino acid decarboxylase inhibitor (AADC-I), it leads to more stable plasma levels of levodopa by reducing metabolism of levodopa to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).
Maltese: Meta amministrat flimkien ma' levodopa u inibitur ta' l-amino acid decarboxylase aromatiku (AADC-I), jista' jwassal għal livelli ta' plażma ta' levodopa aktar stabbli billi jnaqqas il-metaboliżmu ta' levodopa għal 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).
English: Common (≥1/100 to < 1/10)
Maltese: Komuni (>1/100 > 1/10)
English: Distribution: The volume of distribution (Vss) of tolcapone is small (9 l).
Maltese: Il-volum ta' distribuzzjoni (Vss) ta'tolcapone huwa żgħir (9 l).
English: The data of more than 400 patients have confirmed that over a wide range of creatinine clearance values (30-130 mL/min) the pharmacokinetics of tolcapone are unaffected by renal function.
Maltese: L-informazzjoni ta' aktar minn 400 pazjent ikkonfermat li fuq firxa wiesa ta' valuri ta' tneħħija ta' kreatinina (30130 mL/min) il-farmakokinetiċi ta'tolcapone ma jiġux affetwati mill-funzjoni tal-fwied.
English: Clinical Efficacy and Safety
Maltese: Effikaċja Klinika u Sigurtà:
English: Tolcapone markedly reduces the formation of 3-OMD.
Maltese: Tolcapone inaqqas b'mod evidenti il-formazzjoni ta' 3-OMD.
English: Diarrhoea led to withdrawal of 5% and 6% of patients receiving Tasmar 100 mg tid and 200 mg tid respectively, compared to 1 % of patients receiving placebo.
Maltese: Id-dijarrea wasslet għall-waqfien ta' 5% u 6% tal-pazjenti fuq Tasmar 100 mg tid u 200 mg tid rispettivament, imqabbla mal-1% tal-pazjenti li ngħataw plaċebo.
English: EU/1/97/044/007 30 tablets EU/1/97/044/008 60 tablets EU/1/97/044/003 100 tablets EU/1/97/044/0010 200 tablets
Maltese: EU/1/97/044/007 30 pillola EU/1/97/044/008 60 pillola EU/1/97/044/003 100 pillola EU/1/97/044/0010 200 pillola
English: Sleep disorder Dreaming excessive Somnolence Confusion Hallucination
Maltese: Disturb ta' l-irqad Ħolm eċċessiv Sonnolenza Konfużjoni Alluċinazzjoni
English: Tasmar treatment should also be discontinued if ALT (alanine amino transferase) and/or AST (aspartate amino transferase) exceed the upper limit of normal or symptoms or signs suggest the onset of hepatic failure (see section 4.4).
Maltese: Trattament b'Tasmar għandha titwaqqaf ukoll jekk ALT (alanine amino transferase) u/jew AST (aspartate amino transferase) jeċedu l-limitu ta' fuq tas-sintomi normali jew sinjali jissuġġerixxu lbidu ta' insuffiċjenza epatika (ara sezzjoni 4.4).
English: Additionally late onset hepatitis after approximately 18 months of treatment has been reported rarely.
Maltese: Addizzjonalment kienu irrapurtati kazi rari ta' epatite wara 18 il-xahar ta' trattament.
English: Neuroleptic Malignant Syndrome Symptom Complex
Maltese: Kumpless ta' Sintomi tas-Sindrome Newrolettiku Malinn
English: In addition, the compound is methylated by COMT to 3-O-methyl-tolcapone and metabolised by cytochromes P450 3A4 and P450 2A6 to a primary alcohol (hydroxylation of the methyl group), which is subsequently oxidised to the carboxylic acid.
Maltese: 3A4 u P450 2A6 għal alkoħol primarju (idrossillazzjoni tal-kategorija ta' methyl), li sussegwentement jiġi ossidizzat għall-aċtu karbossilliku.
English: Other Medicines and Tasmar
Maltese: Mediċini oħra u Tasmar
English: Tasmar contains lactose
Maltese: Tasmar fih lactose
English: Uncommon (≥1/1,000 to < 1/100)
Maltese: Mhux komuni (>1/1,000 > 1/100)
English: This is due to a decrease in clearance in L-dopa resulting in a prolongation of the terminal elimination half-life (t1/2) of levodopa.
Maltese: Dan minħabba nuqqas fit-tneħħija ta' L-dopa li jwassal biex titwal il-half-life ta' l-eliminazzjoni terminali (t1/2) ta' levodopa.
English: NMS is characterised by motor symptoms (rigidity, myoclonus and tremor), mental status changes (agitation, confusion, stupor and coma), elevated temperature, autonomic dysfunction (labile blood pressure, tachycardia) and elevated serum creatine phosphokinase (CPK) which may be a consequence of myolysis.
Maltese: L-NMS huwa karatterizat minn sintomi tal-moviment (riġidità, mijoklonus, u rogħda), bdil fl-istat mentali (aġitazzjoni, konfużjoni, stat ta' skantament u koma), temperatura elevata, disfunzjoni awtonomika (pressjoni li tvarja, takikardija) u creatine phosphokinase tas-serum elevat (CPK), li jista' jkun konsegwenza ta' mijolisi.
English: Double blind placebo controlled clinical studies have shown a significant reduction of approximately 20 % to 30 % in OFF time and a similar increase in ON time, accompanied by reduced severity of symptoms in fluctuating patients receiving Tasmar.
Maltese: Studji kliniċi tal-plaċebo double-blind kkontrollati wrew tnaqqis sinifikanti ta' madwar 20% sa 30% fil-ħin OFF u żjieda simili fil-ħin ON, akkumpanjat minn tnaqqis fis-severità tas-sintomi f'pazjenti li jvarjaw waqt li jkunu qegħdin jingħataw Tasmar.