FrancophonIA/ELRC3.0 huggingface dataset:
English: While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the Arimidex arm compared to placebo.
Maltese: Filwaqt li n-numru ta' tfalikkurati kien żgħir wisq biex jitfasslu xi konklużjonijiet affidabbli dwar is-sigurtà, kien hemm żieda fir-rata ta' fratturi u tendenza lejn tnaqqis fid-densità minerali tal-fergħa b'Arimidex imqabbla ma' dik ta' plaċebo.
English: Growth rate (in cm/year) was significantly reduced (p<0.05) from pretreatment through month 0 to month 12, and from pre-treatment to the second 6 months (month 7 to month 12).
Maltese: Ir-rata ta' tkabbir (f'cm/sena) kienet imnaqqsa b'mod sinifikanti (p<0.05) minn qabel il-kura bejn xahar 0 sa xahar 12, u minn qabel il-kura sat-tieni 6 xhur (xahar 7 sa xahar 12).
English: Common side effects (affect 1 to 10 people in 100)
Maltese: Effetti sekondarji komuni (jeffettwaw 1 sa 10 minn-nies f'100)
English: Exposure to anastrozole is not increased in subjects with severe renal impairment (GRF<30ml/min, see section 5.2); in patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.2).
Maltese: L-esponiment għal anastrozole jista jiżdied f' nies b' indeboliment epatiku (ara sezzjoni 5.2); l-għotja ta' Arimidex f'pazjenti b' indeboliment epatiku modedrat u qawwi għandu jseħħ b' kawtela (ara sezzjoni 4.2).
English: • Headache.
Maltese: • Uġigħ ta' ras.
English: No data on the potential long-term effects of Arimidex treatment in children and adolescents are available (see also section 5.3).
Maltese: M'hemmx dejta dwar l-effetti fit-tul tal-kura b'Arimidex fit-tfal u l-adolexxenti (ara wkoll sezzjoni 5.3).
English: Oral administration of anastrozole to female rats produced a high incidence of infertility at 1 mg/kg/day and increased pre-implantation loss at 0.02 mg/kg/day.
Maltese: L-għotja ta' anastrozole mill-ħalq lill-firien ta' sess femminili ikkawżat numru kbir ta' infertilità b'1 mg/kg/jum u żiedet it-telf ta' qabel l-impjant b'0.02 mg/kg/jum.
English: NAME OF THE MEDICINAL PRODUCT Arimidex and associated names (see Annex I) 1 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: Arimidex u ismijiet assoċjati (Ara Anness I) 1 mg pilloli miksija b' rita [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Anastrozole is extensively metabolised by postmenopausal women with less than 10% of the dose excreted in the urine unchanged within 72 hours of dosing.
Maltese: Anastrozole jiġi metabolizzat b'mod estensiv f'nisa wara l-menopawża b'anqas minn 10% tad-doża titneħħa fl-awrina mhux mibdula fi żmien 72 siegħa mid-dożaġġ.
English: HOW TO STORE ARIMIDEX
Maltese: Jekk tinsa tieħu Arimidex
English: A two-year rat oncogenicity study resulted in an increase in incidence of hepatic neoplasms and uterine stromal polyps in females and thyroid adenomas in males at the high dose (25 mg/kg/day) only.
Maltese: Studju fuq l-effett kanċeroġenu fil-firien li dam sentejn wassal f'żieda fil-każijiet ta' nejoplażmi filfwied u polipi fl-istroma tal-utru tal-firien ta' sess femminili u adenomi tat-tajrojd fil-firien ta' sess maskili b'dożi għoljin (25 mg/kg/jum) biss.
English: Since anastrozole reduces estradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Maltese: Peress li anastrozole inaqqas il-livelli ta' estradajol, Arimidex m'għandux jintuża fi bniet b'nuqqas tal-ormon tat-tkabbir bħala kura addizzjonali mal-ormon tat-tkabbir.
English: [See Annex I - To be completed nationally] anastrozole
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] anastrozole
English: LABELLING
Maltese: Ostejoporożi
English: If you go into the hospital, let the medical staff know you are taking Arimidex.
Maltese: Jekk m'intix ċert/a, kellem littabib jew spiżjar tiegħek qabel tieħu Arimidex.
English: LIST OF EXCIPIENTS Contains lactose.
Maltese: Dan il-prodott fih lactose.
English: This belongs to a group of medicines called ‘aromatase inhibitors'.
Maltese: Dan jgħamel parti minn grupp ta' mediċini li jissejjħu ‘inibituri ta' aromatase'.
English: Exposure to anastrozole can be increased in subjects with hepatic impairment (see section 5.2); administration of Arimidex in patients with moderate and severe hepatic impairment should be performed with caution (see section 4.2).
Maltese: Studji fl-annimali wrew tossiċita' riproduttiva (ara sezzjoni 5.3). Arimidex huwa kontra-indikat waqt it-tqala (ara sezzjoni 4.3).
English: The 12-month main analysis has shown that patients already at moderate to high risk of fragility fracture showed no decrease in their bone mass density (assessed by lumbar spine bone mineral density using DEXA scanning) when managed by using Arimidex 1 mg/day in combination with risedronate 35 mg once a week.
Maltese: L-analiżi ewlenija wara 12-il xahar wriet li pazjenti li diġà kellhom riskju ta' frattura moderat sa' għoli ma kellhomx tnaqqis fid-densità tal-massa tal-għadam tal-ispina (stmata mid-densità minerali talispina lumbari permezz ta' skan DEXA) meta immaniġġjata b'Arimidex 1 mg/jum flimkien ma' residronate 35 mg darba fil-ġimgħa.
English: Unless specified, the frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer given adjuvant treatment for five years (the Arimidex, Tamoxifen, Alone or in Combination [ATAC] study).
Maltese: III li sar fuq 9,366 mara wara lmenopawża b'marda tal-kanċer tas-sider operabbli li ingħataw kura miżjuda għal ħames snin (l-istudju Arimidex, Tamoxifen waħdu jew Kombinat [ATAC]).
English: Hazard ratio 2-sided 95% CI
Maltese: Sopravivenza mingħajr il-marda Proporzjon ta' periklu 95% CI b'2 lati
English: • Hives or nettle rash.
Maltese: • Ħorriqija jew raxx irritanti.
English: The Arimidex safety profile in these 3 studies was consistent with the known safety profile established in postmenopausal women with hormone receptor-positive early breast cancer.
Maltese: Il-profil ta' sigurtà ta' Arimidex f'dawn it-3 studji kien konsistenti mal-profil tas-sigurtà magħruf li kien stabbilit f'nisa wara l-menopawża b'riċettur pożittiv tal-ormon b'kanċer tas-sider bikri.
English: Adjuvant treatment of early invasive breast cancer for hormone receptor-positive patients being treated with adjuvant tamoxifen
Maltese: Kura addizzjonali ta' kanċer tas-sider invażiv bikri għall-pazjenti pożittivi għar-riċettur tal-ormon li kienu qed jingħataw kura addizzjonali b'tamoxifen
English: These effects were related to the pharmacological effects of the compound on parturition.
Maltese: Dawn l-effetti kienu relatati maleffett farmakoloġiku tas-sustanza waqt it-twelid.
English: Detailed information on this medicine is available on the web site of {MA/Agency}
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' {isem ta' l-Istat Membru/Aġenzija}
English: - The active substance is anastrozole.
Maltese: Sustanzi mhux attivi.
English: It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on Arimidex treatment reflect a protective effect of tamoxifen, a specific effect of Arimidex, or both.
Maltese: Bħal kull mediċina oħra, Arimidex jista' jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
English: p-value Distant disease-free survivalb 500 (16.0) 530 (17.0) 370 (14.1) 394 (15.2)
Maltese: Effetti sekondarji mhux komuni (jeffettwaw 1 sa 10 minn-nies f'1,000)
English: It may harm them,
Maltese: Dan itaqqab ilkapsula.
English: Godfried Bomansstraat 31 6543 JA Nijmegen Netherlands
Maltese: Godfried Bomansstraat 31 6543 JA Nijmegen in-Netherlands
English: Placebo n = 112
Maltese: Plaċebo n = 112
English: 2 doses
Maltese: 2 dożi
English: Hypromellose Titanium dioxide (E 171) Carrageenan
Maltese: Titanium dioxide (E 171) Carrageenan
English: EU/1/19/1390/001 EU/1/19/1390/002
Maltese: EU/1/19/1390/002
English: Mental disturbances
Maltese: Disturbi mentali
English: Henoch-Schonlein purpura, Urticaria,
Maltese: Purpura ta' Henoch-Schonlein, Urtikarja,
English: Alopecia,
Maltese: Alopeċja,
English: Pulmonary safety
Maltese: Sigurtà pulmonari
English: 2 doses a Observed cases.
Maltese: 2 dożi a Każijiet osservati.
English: Central Nervous System (CNS) effects and mental disturbances
Maltese: Effetti fuq is-Sistema Nervuża Ċentrali (CNS, Central Nervous System) u disturbi mentali
English: Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380
Maltese: Earlsfort Terrace Dublin 2, D02 T380
English: Levodopa is extensively metabolised to various metabolites.
Maltese: Levodopa huwa metabolizzat b'mod estensiv f'diversi metaboliti.
English: Alanine aminotransferase increased,
Maltese: Żieda f'alanine aminotransferase,
English: c p-value for PGI-C is nominal.
Maltese: c il-valur p għal PGI-C huwa nominali.
English: System Organ Class
Maltese: Sistema ta' Klassifika tal­Organi
English: Malignant melanoma
Maltese: Melanoma malinni
English: 64 years
Maltese: 64 sena
English: For more information see section 4.
Maltese: Għal aktar informazzjoni ara sezzjoni 4.
English: Intercurrent respiratory infection
Maltese: Infezzjoni interkurrenti tas-sistema respiratorja
English: Aspartate aminotransferase increased,
Maltese: Żieda f'aspartate aminotransferase,
English: Cardiovascular ischaemic events
Maltese: Avvenimenti iskemiċi kardjovaskulari
English: Duration PD
Maltese: Tul PD
English: % (n) Diff. p-value
Maltese: % (n) Diff.
English: The Inbrija inhaler is made of polybutylene terephthalate (PBT), polycarbonate (PC) and polypropylene (PP).
Maltese: L-inalatur ta' Inbrija huwa magħmul minn polybutylene terephthalate (PBT), polycarbonate (PC) u polypropylene (PP).
English: Repeat Steps 4 to 10 with the second capsule to finish the full dose.
Maltese: Irrepeti Passi 4 sa 10 bit-tieni kapsula biex tlesti ddoża sħiħa.
English: Apparent volume of distribution (Vz/F) was 168 L for Inbrija 66 mg (2 x 33 mg capsules).
Maltese: Il-volum apparenti tad-distribuzzjoni (Vz/F) kien 168 L għal Inbrija 66 mg (2 x 33 mg kapsuli).
English: Selective Monoamine Oxidase (MAO) inhibitors
Maltese: Inibituri Selettivi ta' Monoamine Oxidase (MAO)
English: Each hard capsule contains 42 mg levodopa.
Maltese: Kull kapsula iebsa fiha 42 mg ta' levodopa.
English: Contains colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide.
Maltese: Fih colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide.
English: Angioedema,
Maltese: Anġjoedema,
English: Inbrija shows dose proportional pharmacokinetics of levodopa from 13 mg to 122 mg.
Maltese: Inbrija juri farmakokinetika proporzjonali għad-doża ta' levodopa minn 13 mg għal 122 mg.
English: EU/1/19/1390/001 60 hard capsules EU/1/19/1390/002 92 hard capsules
Maltese: EU/1/19/1390/002 92 kapsula iebsa
English: Impulse control disorders
Maltese: Disturbi tal-kontroll tal-impuls
English: Full dose = 2 capsules.
Maltese: Doża sħiħa = 2 kapsuli.
English: Much improved % (n) Improved % (n) Little improved % (n) Not improved % (n) p-value
Maltese: % imtejjeb ħafna (n) % imtejjeb (n) % imtejjeb ftit (n) % mhux imtejjeb (n)
English: This normally takes several seconds.
Maltese: Normalment dan jieħu diversi sekondi.
English: Step 11: Dose with 2nd capsule
Maltese: Il-11-il Pass: Doża bit-tieni kapsula
English: 63 years
Maltese: 63 sena
English: These medicines include isocarboxazid and phenelzine.
Maltese: Dawn il-mediċini jinkludu isocarboxazid u phenelzine.
English: Blue Handle Capsule Chamber White Mouthpiece Blue Cap
Maltese: Manku Blu Post għall-Kapsula Parti Bajda għall-Ħalq Għatu Blu
English: Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactic dehydrogenase (LDH), and bilirubin.
Maltese: Anormalitajiet fit-testijiet tal-laboratorju jistgħu jinkludu testijiet għal żidiet fil-funzjoni tal-fwied bħal alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactic dehydrogenase (LDH), u bilirubin.
English: The most frequent adverse reactions reported in the Inbrija clinical studies were cough (15.6%), fall (8.7%), upper respiratory tract infection (5.8%), dyskinesia (5.7%) and sputum discoloured (2.8%).
Maltese: 6%), waqgħa (8.7%), infezzjoni fil-parti ta' fuq tal-apparat respiratorju (5.8%), diskineżija (5.7%) u tibdil fil-kulur tal-isputum (2.8%).
English: Pre-dose score Change at 30 min Diff. (95% CI) p-value
Maltese: Punteġġ ta' qabel id-doża Bidla wara 30 min Diff. (95% CI)
English: UPDRS-III was assessed before and 30 minutes post dose administration.
Maltese: UPDRS-III kien ivvalutat qabel u 30 minuta wara l-għoti tad-doża.
English: There is limited data regarding chronic effect of Inbrija in respiratory compromised patients.
Maltese: Hemm data limitata rigward l-effett kroniku ta' Inbrija f'pazjenti bis-sistema respiratorja kkompromizzata.
English: Oedema peripheral, Asthenia,
Maltese: Edema periferali, Astenja,
English: - The other ingredients comprising the powder and capsule are colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol and potassium hydroxide.
Maltese: - Is-sustanzi mhux attivi l-oħra huma colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol u potassium hydroxide.
English: Responders ONb n = 97a n = 97a
Maltese: Rispondenti ONb n = 97a n = 97a
English: Adverse reactions in clinical trials with Inbrija
Maltese: Reazzjonijiet avversi fil-provi kliniċi b'Inbrija
English: The mean maximal plasma concentration at 10 minutes (C10min) and at peak concentration (Cmax) of levodopa following administration of Inbrija 66 mg (2 x 33 mg capsules) was 418 ng/mL and 696 ng/mL, respectively, with exposure over 4 hours (AUC0-4 h) of 1,280 ng●h/mL.
Maltese: Il-konċentrazzjoni fil-plażma massima medja wara 10 minuti (C10min) u fl-ogħla konċentrazzjoni (Cmax) ta' levodopa wara l-għoti ta' Inbrija 66 mg (2 x 33 mg kapsuli) kienet 418 ng/mL u 696 ng/mL, rispettivament, b'esponiment fuq 4 sigħat (AUC0-4 sigħat) ta' 1,280 ng●h/mL.
English: Paranoia,
Maltese: Paranoja, Delużjoni
English: The two major metabolic pathways are decarboxylation by L-aromatic amino acid decarboxylase and O-methylation by catechol-Omethyltransferase (COMT).
Maltese: Iż-żewġ mogħdijiet metaboliċi ewlenin huma d-dekarbossilazzjoni b'L-aromatic amino acid decarboxylase u O-methylation b'catechol-O-methyltransferase (COMT).
English: Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa.
Maltese: Antagonisti tar-riċettur D2 tad-dopamine (eż. phenothiazines, butyrophenones, risperidone, metoclopramide) u isoniazid jistgħu jnaqqsu l-effettività ta' levodopa.
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżmu u n­nutrizzjoni
English: Falsenegative tests may result with the use of glucose-oxidase methods of testing for glucosuria.
Maltese: Testijiet negattivi foloz jistgħu jirriżultaw mill-użu ta' metodi ta' ttestjar għal glukusurja bi glucose-oxidase.
English: Dopamine D2 receptor antagonists and isoniazid
Maltese: Antagonisti tar-riċettur D2 tad-dopamine u isoniazid
English: Baseline mean (SD) LS mean change Mean diff. (95% CI) p-value
Maltese: Medja fil-linja bażi (SD) Bidla medja f'LS Diff. medja (95% CI)
English: The primary efficacy endpoint was the mean change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) part III score 30 minutes post dose at week 12.
Maltese: III talIskala ta' Klassifikazzjoni tal-Marda ta' Parkinson Unifikata (UPDRS, Unified Parkinson's Disease Rating Scale) 30 minuta wara d-doża f'ġimgħa 12.
English: The active substance in Inbrija is levodopa.
Maltese: Is-sustanza attiva f'Inbrija hija levodopa.
English: Gastrointestinal haemorrhage has been reported with levodopa medicinal products and was observed once in Inbrija clinical studies.
Maltese: Emorraġija gastrointestinali ġiet irrappurtata bi prodotti mediċinali ta' levodopa u ġiet osservata darba fi studji kliniċi b'Inbrija.
English: There is limited data available on the use of Inbrija during a respiratory infection.
Maltese: Hemm data limitata disponibbli dwar l-użu ta' Inbrija matul infezzjoni respiratorja.
English: Tricyclic antidepressants
Maltese: Antidipressanti triċikliċi
English: Local or systemic pulmonary medicinal products
Maltese: Prodotti mediċinali pulmonari lokali jew sistemiċi
English: Carton containing 92 hard capsules (23 blister strips) and one inhaler.
Maltese: Kartuna li fiha 92 kapsula iebsa (23 strixxa bil-folji) u inalatur wieħed.
English: There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and a levodopa/dopa-decarboxylase inhibitor.
Maltese: Kien hemm rapporti rari ta' reazzjonijiet avversi, inkluż pressjoni għolja u diskineżija, li rriżultaw mill-użu fl-istess ħin ta' antidipressanti triċikliċi u inibitur ta' levodopa/dopa-decarboxylase.
English: Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku
English: After administration of Inbrija the Cmax and AUC0-24 h for women were 42.2% higher and 48.8% higher than for men, respectively.
Maltese: Wara l-għoti ta' Inbrija is-Cmax u l-AUC0-24 siegħa għan-nisa kienu 42.2% ogħla u 48.8% ogħla minn dawk għall-irġiel, rispettivament.
English: Inbrija 33 mg inhalation powder, hard capsules levodopa
Maltese: Inbrija 33 mg trab li jittieħed man-nifs, kapsuli ibsin levodopa
English: Restless legs syndrome, Neuroleptic malignant syndrome (see section 4.4), Ataxia,
Maltese: Sindrome malinn newroleptiku (ara sezzjoni 4.4), Atassija,
English: Fall a Cardiac rhythm disorder here is a combined term representing atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia.
Maltese: Waqgħa a Disturb fir-ritmu tal-qalb hawnhekk huwa terminu kombinat li jirrappreżenta fibrillazzjoni atrijali, taħbit atrijali irregolari, imblokk atrioventrikulari, imblokk fil-bundle branch, sindrome tas-sinus marid, bradikardija,
English: This abnormal thinking and behaviour can consist of one or more of a variety of manifestations including anxiety, depression, paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Maltese: Dawn il-ħsibijiet u mġiba anormali jistgħu jikkonsistu f'waħda jew aktar minn varjetà ta' manifestazzjonijiet inkluż ansjetà, dipressjoni, ħsibijiet paranojiċi, delużjonijiet, alluċinazzjonijiet, konfużjoni, imġiba qisha psikotika, disorjentazzjoni, imġiba aggressiva, aġitazzjoni, u delirju.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Abnormalities in blood urea nitrogen (BUN) and positive Coombs test have also been reported.
Maltese: Anormalitajiet fin-nitroġenu tal-urea fid-demm (BUN, blood urea nitrogen) u test Coombs pożittiv ukoll ġew irrappurtati.
English: Carton containing 60 hard capsules (15 blister strips) and one inhaler.
Maltese: Kartuna li fiha 60 kapsula iebsa (15-il strixxa bil-folji) u inalatur wieħed.
English: Apomorphine was not allowed as background medicinal product.
Maltese: Apomorphine ma kinitx permessa bħala prodott mediċinali fl-isfond.
English: Pharmacotherapeutic group: Anti-Parkinson drugs, dopaminergic agents, ATC code: N04BA01 Mechanism of action
Maltese: Mediċini kontra l-marda ta' Parkinson, aġenti dopaminerġiċi, Kodiċi ATC:
English: The pharmacokinetics of Inbrija 66 mg (2 x 33 mg capsules) and carbidopa/levodopa 25 mg/100 mg immediate release tablets was evaluated in 24 healthy volunteers in a fasted state receiving a total of 50 mg carbidopa every 8 hours.
Maltese: Il-farmakokinetika ta' Inbrija 66 mg (2 x 33 mg kapsuli) u carbidopa/levodopa 25 mg/100 mg pilloli li jerħu l-mediċina b'mod immedjat ġiet evalwata f'24 voluntiera b'saħħithom fi stat ta' sawm li rċivew total ta' 50 mg carbidopa kull 8 sigħat.
English: Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
Maltese: Inbrija huwa indikat għat-trattament intermittenti ta' flutwazzjonijiet motorji episodiċi (episodji OFF) f'pazjenti adulti bil-marda ta' Parkinson (PD, Parkinson's disease) ittratti b'inibitur ta' levodopa/dopadecarboxylase.
English: Cognitive disorder, Horner's syndrome, Dementia
Maltese: Disturbi fit-togħma, Disturb konoxxittiv, Sindrome ta' Horner, Dimenzja
English: Frequency categories are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), not known
Maltese: Il-kategoriji ta' frekwenza huma definiti kif ġej: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Gastrointestinal haemorrhage, Peptic ulcer (see section 4.4), Dysphagia,
Maltese: Ulċera peptika (ara sezzjoni 4.4), Disfaġja,
English: - a carton containing 60 hard capsules (15 blister strips) and one inhaler - a carton containing 92 hard capsules (23 blister strips) and one inhaler
Maltese: Id-daqsijiet tal-pakkett huma - kartuna li fiha 60 kapsula iebsa (15-il strixxa bil-folji) u inalatur wieħed - kartuna li fiha 92 kapsula iebsa (23 strixxa bil-folji) u inalatur wieħed
English: A total of 271 patients were treated with Inbrija 66 mg (two 33 mg capsules), and 127 patients in an observational control group were observed on their regular oral medication regimen for the treatment of Parkinson's disease.
Maltese: Total ta' 271 pazjent kienu ttrattati b'Inbrija 66 mg (żewġ kapsuli ta' 33 mg), u 127 pazjent fi grupp ta' kontroll ta' osservazzjoni kienu osservati fil-kors ta' mediċina mill-ħalq regolari tagħhom għat-trattament tal-marda ta' Parkinson.
English: Non-selective Monoamine Oxidase (MAO) inhibitors The use of non-selective MAO inhibitors with levodopa is contraindicated (see section 4.3).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Inibituri Mhux Selettivi ta' Monoamine Oxidase (MAO) L-użu ta' inibituri mhux selettivi ta' MAO ma' levodopa huwa kontraindikat (ara sezzjoni 4.3).
English: Other medicines and Inbrija
Maltese: Mediċini oħra u Inbrija
English: Anticholinergics
Maltese: Antikolinerġiċi
English: Worsening of Parkinson's disease,
Maltese: Aggravar tal-marda ta' Parkinson,
English: Vision blurred, Diplopia, Mydriasis, Oculogyric crisis, Blepharospasm
Maltese: Vista mċajpra, Diplopja, Midrijasi, Kriżi okuloġirika, Blefarospażmu
English: Do not swallow Inbrija capsules.
Maltese: Tiblax il-kapsuli ta' Inbrija.
English: The pharmacokinetics of the major levodopa metabolites 3-O-methyldopa (3-OMD), 3,4dihydroxyphenylacetic acid (DOPAC) and homovanillic acid (HVA) were studied following administration of a single inhaled dose of Inbrija and a single oral carbidopa/levodopa 25 mg/100 mg immediate release tablet.
Maltese: Il-farmakokinetika tal-metaboliti maġġuri ta' levodopa 3-O-methyldopa (3-OMD), 3,4dihydroxyphenylacetic acid (DOPAC) u homovanillic acid (HVA) ġiet studjata wara l-għoti ta' doża waħda ta' Inbrija meħuda man-nifs u pillola waħda li terħi l-mediċina b'mod immedjat ta'