FrancophonIA/ELRC3.0 huggingface dataset:
English: In study CQVJ499A2401, SIMBRINZA + PGA (i.e. travoprost, latanoprost, or bimatoprost) demonstrated superior IOP-lowering efficacy from baseline compared to Vehicle + PGA after 6 weeks of treatment, with between-treatment difference in model-adjusted mean change from baseline in diurnal IOP of -3.44 mmHg (95% CI, -4.2, -2.7; p-value <0.001).
Maltese: Flistudju CQVJ499A2401, SIMBRINZA + PGA (jiġifieri travoprost, latanoprost jew bimatoprost) urew effikaċja superjuri biex inaqqsu l-IOP mil-linja bażi meta mqabbla mal-Veikolu + PGA wara 6 ġimgħat ta' kura, b'differenza bejn il-kura fil-bidla medja aġġustata skont il-mudell mil-linja bażi f'IOP matul il-jum ta' -3.44 mmHg (95% CI, -4.2, -2.7; valur p <0.
English: 2, bradycardia
Maltese: 2, bradikardija takikardija
English: SIMBRINZA with alcohol
Maltese: SIMBRINZA mal-alkoħol
English: Oral overdoses of other alpha-2-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
Maltese: B'dożi eċċessivi mill-ħalq ta 'agonisti oħra ta 'alpha-2 ġew irrappurtati li jikkawżaw sintomi bħal pressjoni baxxa, astenja, rimettar, letarġija, sedazzjoni, bradikardija, arritmija, mijosi, apnea, ipotonija, ipotermja, depressjoni respiratorja u aċċessjoni.
English: Uncommon: dermatitis contact
Maltese: Mhux komuni: dermatite tal-kuntatt
English: Pharmacotherapeutic group: Ophthalmologicals, Antiglaucoma preparations and miotics, ATC code: S01EC54
Maltese: Oftalmoloġiċi, Preparazzjonijiet kontra l-glawkoma u mijotiċi, Kodiċi ATC:
English: • Effects in the eye: decreased pupil size
Maltese: • Effetti fl-għajn: tnaqqis fid-daqs tal-pupilla
English: Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.
Maltese: Effetti gastro-intestinali, fis-sistema nervuża, ematoloġiċi, fil-kliewi u fil-metaboliżmu, ġeneralment huma assoċjati ma 'inibituri sistemiċi ta 'carbonic anhydrase.
English: In a study of brinzolamide in subjects with renal impairment, a 1.6- to 2.8-fold increase in the systemic exposure to brinzolamide and N-desethylbrinzolamide between normal and moderately renally-impaired subjects was demonstrated.
Maltese: Fi studju ta 'brinzolamide f'individwi b'indeboliment tal-kliewi, intweriet żieda ta '1.6 sa 2.8 darbiet fl-esponiment sistemiku għal brinzolamide u N-desethylbrinzolamide bejn individwi normali u individwi b'indeboliment moderat tal-kliewi.
English: Brimonidine, an alpha-2 adrenergic agonist, inhibits the enzyme adenylate cyclase and suppresses the cAMP-dependent formation of aqueous humour.
Maltese: Brimonidine, agonist alfa-2 adrinerġiku, jinibixxi l-enzima adenylate cyclase u jrażżan il-formazzjoni tal-umur akweju dipendenti fuq cAMP.
English: SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, suspension
Maltese: SIMBRINZA 10 mg/mL + 2 mg/mL qtar għall-għajnejn, suspensjoni
English: Uncommon: erectile dysfunction
Maltese: Mhux komuni: disfunzjoni erettili
English: 1 mL of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg of brimonidine.
Maltese: U KWANTITATTIVA 1 mL ta 'suspensjoni fih 10 mg ta 'brinzolamide u 2 mg ta 'brimonidine tartrate ekwivalenti għal 1.3 mg ta 'brimonidine.
English: methazolamide and dorzolamide - medicines that can affect the metabolism, such as chlorpromazine, methylphenidate and reserpine - antiviral, antiretroviral (used to treat Human Immunodeficiency Virus (HIV)) or antibiotic medicines - antiyeast or antifungal medicines - monoamine oxidase (MAO) inhibitors, or antidepressants including amitriptyline, nortriptyline,
Maltese: (HIV - Human Immunodeficiency Virus)) jew antibijotiċi - mediċini kontra l-ħmira jew kontra l-moffa - inibituri ta' monoamine oxidase (MAO), jew antidepressanti inkluż amitriptyline, nortriptyline,
English: 1, corneal deposits (keratic precipitates)
Maltese: 2, blefarite depożiti fil-kornea (preċipitati keratiċi)
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħrufa (il-frekwenza ma tistax tiġi stmata minn dejta disponibbli)
English: 2, angina pectoris
Maltese: 2, anġina pektoris arritmija
English: Non-clinical data do not show any effects of brinzolamide or brimonidine on fertility.
Maltese: Dejta mhux klinika ma turi l-ebda effetti ta 'brinzolamide jew brimonidine fuq il-fertilità.
English: A study of brinzolamide in Japanese versus non-Japanese subjects showed similar systemic pharmacokinetics between the two groups.
Maltese: Studju ta 'brinzolamide f'individwi Ġappuniżi kontra dawk mhux Ġappuniżi wera farmakokinetika sistemika simili bejn iż-żewġ gruppi.
English: The safety profile of SIMBRINZA in adjunct therapy was similar to that observed with SIMBRINZA monotherapy.
Maltese: Il-profil tas-sigurtà ta' SIMBRINZA fit-terapija flimkien ma' terapiji oħra kien simili għal dak osservat b'monoterapija b'SIMBRINZA.
English: Symptoms of brimonidine overdose (including loss of consciousness, hypotension, hypotonia, bradycardia, hypothermia, cyanosis and apnoea) have been reported in neonates and infants receiving brimonidine eye drops as part of medical treatment of congenital glaucoma.
Maltese: Sintomi ta' doża eċċessiva ta 'brimonidine (inkluż telf tal-koxxjenza, pressjoni baxxa, ipotonija, bradikardija, ipotermja, ċjanożi u apnea) kienu rrappurtati fi trabi tat-twelid u trabi li rċevew qtar għall-għajnejn brimonidine bħala parti mill-kura medika ta 'glawkoma konġenitali.
English: SIMBRINZA is contraindicated in patients receiving monoamine oxidase inhibitors and in patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin), (see section 4.3).
Maltese: SIMBRINZA huwa kontraindikat f'pazjenti li jirċievu inibituri ta 'monoamine oxidase u f'pazjenti fuq antidepressanti li jaffettwaw it-trasmissjoni noradrenerġika (eż. antidepressanti triċikliċi u mianserin), (ara sezzjoni 4.3).
English: Dysgeusia was the most common systemic adverse reaction associated with the use of SIMBRINZA (3.4%).
Maltese: Disġewżja kienet l-aktar reazzjoni avversa sistemika komuni assoċjata mal-użu ta 'SIMBRINZA (3.4%).
English: SIMBRINZA 10 mg/ml + 2 mg/ml eye drops brinzolamide/brimonidine tartrate
Maltese: SIMBRINZA 10 mg/ml + 2 mg/ml qtar għall-għajnejn brinzolamide/brimonidine tartrate
English: Statistically superior reductions in the mean diurnal IOP were observed with SIMBRINZA compared to brinzolamide 10 mg/ml or brimonidine 2 mg/ml dosed twice daily at all visits throughout the study (Figure 1).
Maltese: Tnaqqis statistikament superjuri fl-IOP medja ta' matul il-ġurnata kien osservat b'SIMBRINZA meta mqabbel ma 'brinzolamide 10 mg/ml jew brimonidine 2 mg/ml mogħti darbtejn kuljum fil-visti kollha matul l-istudju (Figura 1).
English: 2, flatulence hypoaesthesia oral
Maltese: 2, ipoestesija orali parestesija orali
English: In humans, urinary brinzolamide and Ndesethylbrinzolamide accounted for about 60 and 6% of the dose, respectively.
Maltese: Fil-bniedem, brinzolamide flawrina u N-desethylbrinzolamide kienu responsabbli għal madwar 60 u 6% tad-doża, rispettivament.
English: Tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Maltese: Ammonti żgħar ta 'hydrochloric acid u/jew sodium hydroxide huma miżjuda biex iżommu l-livelli talaċidità (livelli tal-pH) normali.
English: SIMBRINZA 10 mg/ml + 2 mg/ml eye drops, suspension brinzolamide/brimonidine tartrate
Maltese: SIMBRINZA 10 mg/ml + 2 mg/ml qtar għall-għajnejn, suspensjoni brinzolamide/brimonidine tartrate
English: Brinzolamide was not teratogenic in rats and rabbits, following systemic administration (oral gavage).
Maltese: Brinzolamide ma kienx teratoġeniku fil-firien u l-fniek, wara għoti sistemiku (tubu orali).
English: 1, rhinorrhoea
Maltese: 1, dijarea rimettar
English: 2, diplopia glare
Maltese: 2, diplopja
English: SIMBRINZA contains two active substances: brinzolamide and brimonidine tartrate.
Maltese: SIMBRINZA fih żewġ sustanzi attivi: brinzolamide u brimonidine tartrate.
English: Eye drops, suspension (eye drops).
Maltese: Qtar għall-għajnejn, suspensjoni (qtar għall-għajnejn).
English: This increase in steady-state RBC concentrations of substance-related material did not inhibit RBC carbonic anhydrase activity to levels that are associated with systemic side effects.
Maltese: Din iż-żieda fil-konċentrazzjonijiet ta 'RBC fi stat fiss ta 'materjal relatat mas-sustanza ma kienx jinibixxi l-attività ta 'carbonic anhydrase f'RBC għal livelli li huma assoċjati ma 'effetti sekondarji sistemiċi.
English: At the +2 h time point (the time corresponding to the morning efficacy peak) for the primary efficacy visit at Month 3, the percentage of patients with an IOP less than 18 mmHg was 61.7% in the SIMBRINZA group, 40.1% in the Brinzolamide group, and 40.0% in the Brimonidine group.
Maltese: Fil-punt ta 'ħin ta '+2 sigħat (il-ħin li jikkorrispondi għall-quċċata tal-effikaċja ta 'filgħodu) għall-vista primarja tal-effikaċja f'Xahar 3, ilperċentwali ta 'pazjenti b'IOP inqas minn 18 mmHg kien ta' 61.7% fil-grupp ta 'SIMBRINZA, 40.1% fil-grupp ta 'Brinzolamide, u 40.0% fil-grupp ta 'Brimonidine.
English: 2, sinusitis
Maltese: 2, sinużite
English: Date of first authorisation: 18 July 2014 Date of last renewal: 20 February 2019
Maltese: Data tal-aħħar tiġdid: 20 Frar 2019
English: In a 6-month, controlled, non-inferiority clinical study enrolling 890 patients with open-angle glaucoma (including pseudoexfoliation or pigment dispersion component) and/or ocular hypertension who, in the investigator's opinion, were insufficiently controlled on monotherapy or already on multiple IOP-lowering medicinal products, and who had mean baseline diurnal IOP of 26 to 27 mmHg, non-inferiority of SIMBRINZA compared to brinzolamide 10 mg/mL + brimonidine 2 mg/mL dosed concomitantly was demonstrated at all visits throughout the study with respect to mean diurnal IOP reduction from baseline (Table 1).
Maltese: Fi studju kliniku ikkontrollat dwar nuqqas ta 'inferjorità li dam 6 xhur u li rreġistra 890 pazjent bi glawkoma tat-tip open-angle (inkluż psewdoeksfoljazzjoni jew komponent ta 'dispersjoni ta 'pigment) u/jew pressjoni għolja fl-għajn li, fl-opinjoni tal-investigatur, ma kinux ikkontrollati biżżejjed b'monoterapija jew li diġà kienu qed jieħdu bosta prodotti mediċinali li jbaxxu l-IOP, u li kellhom IOP medja ta 'matul il-ġurnata fil-linja bażi ta '26 sa 27 mmHg, in-nuqqas ta 'inferjorità ta 'SIMBRINZA meta mqabbel ma 'brinzolamide 10 mg/mL + brimonidine 2 mg/mL mogħtija flimkien intweriet filvisti kollha matul l-istudju rigward it-tnaqqis medju fl-IOP ta' matul il-ġurnata mil-linja bażi (Tabella 1).
English: Uncommon: headache
Maltese: Mhux komuni: uġigħ
English: -8.1 (n=346) -8.2 (n=330)
Maltese: -8.1 (n=346)
English: Brimonidine tartrate may cause ocular allergic reactions.
Maltese: Brimonidine tartrate jista 'jikkawża reazzjonijiet allerġiċi fl-għajn.
English: SIMBRINZA is absorbed systemically and this may therefore occur with topical administration (see section 4.7).
Maltese: SIMBRINZA huwa assorbit sistemikament u dan jista 'għalhekk iseħħ b'għoti topiku (ara sezzjoni 4.7).
English: 3, miosis Not known: visual disturbances
Maltese: 3, mijosi Mhux magħrufa: disturbi fil-vista
English: 8 mL round, opaque, low density polyethylene (LDPE) bottles with a LDPE dropper tip and white polypropylene screw cap (Drop-Tainer) containing 5 mL suspension.
Maltese: In-natura tal-kontenitur u ta 'dak li hemm ġo fih Fliexken tondi u opaki ta '8 mL tal-polyethylene ta 'densità baxxa (LDPE - low density polyethylene) bit-tarf tal-qattara tal-LDPE u b'għatu bil-kamin ta' lewn abjad tal-polypropylene (Drop-Tainer) li fihom 5 mL ta 'suspensjoni.
English: SIMBRINZA contains two active substances, brinzolamide and brimonidine tartrate.
Maltese: SIMBRINZA fih żewġ sustanzi attivi, brinzolamide u brimonidine tartrate.
English: Tabulated summary of adverse reactions
Maltese: Sommarju f'tabella ta 'reazzjonijiet avversi
English: SIMBRINZA is contraindicated in patients with severe renal impairment (see section 4.3).
Maltese: SIMBRINZA huwa kontraindikat f'pazjenti b'indeboliment sever talkliewi (ara sezzjoni 4.3).
English: The effects of renal and hepatic impairment on the systemic pharmacokinetics of brimonidine have not been evaluated.
Maltese: L-effetti ta 'indeboliment tal-kliewi u tal-fwied fuq ilfarmakokinetika sistemika ta 'brimonidine ma ġewx evalwati.
English: SIMBRINZA has not been studied in patients with severe renal impairment (CrCl <30 mL/min) or in patients with hyperchloraemic acidosis.
Maltese: SIMBRINZA ma ġiex studjat f'pazjenti b'indeboliment sever tal-kliewi (CrCl < 30 mL/min) jew f'pazjenti b'aċidożi iperklorimika.
English: This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).
Maltese: Dan jista 'jirriżulta fi tnaqqis fl-effetti sekondarji sistemiċi u żieda fl-attività lokali (ara sezzjoni 4.4).
English: Data in rats showed some biliary excretion (about 30%), primarily as metabolites.
Maltese: Dejta fil-firien uriet xi tneħħija fil-bili (madwar 30%), primarjament bħala metaboliti.
English: Tricyclic antidepressants may blunt the ocular hypotensive response of SIMBRINZA.
Maltese: Antidepressanti triċikliċi jistgħu jtellfu r-rispons ipotensiv fl-għajn ta ' SIMBRINZA.
English: In rats doses of 18 mg/kg/day (783 times the recommended daily clinical dose), but not 6 mg/kg/day, resulted in slightly reduced ossification of skull and sternebrae of foetuses.
Maltese: Fil-firien dożi ta '18 mg/kg/jum (783 darba d-doża klinika rakkomandata kuljum), iżda mhux 6 mg/kg/jum, wasslu għal ossifikazzjoni kemmxejn imnaqqsa tal-kranju u talisternebrae tal-feti.
English: The frequency of an allergic reaction to the medicine is not known (frequency cannot be estimated from the available data).
Maltese: Ilfrekwenza ta' reazzjoni allerġika għall-mediċina mhix magħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli).
English: At the +2 h time point (the time corresponding to the morning efficacy peak) for the primary efficacy visit at Month 3, the percentage of patients with an IOP less than 18 mmHg was 65.6% in the SIMBRINZA group and 63.7% in the Brinzolamide + Brimonidine groups.
Maltese: Fil-punt ta 'ħin ta' +2 sigħat (il-ħin li jikkorrispondi għall-quċċata tal-effikaċja ta' filgħodu) għall-vista primarja tal-effikaċja f'Xahar 3, ilperċentwali ta' pazjenti b'IOP inqas minn 18 mmHg kien ta' 65.6% fil-grupp ta' SIMBRINZA u ta' 63.7% fil-grupp ta 'Brinzolamide+brimonidine.
English: 1, oesophagitis
Maltese: 1, astenopja
English: 2, scleral pigmentation
Maltese: 2, pigmentazzjoni tal-isklera
English: The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta 'SIMBRINZA fi tfal u adolexxenti b'età minn sentejn sa 17-il sena ma ġewx determinati s'issa.
English: Treatment of children 2 years and above (especially those in the 2-7 age range and/or weighing <20 kg) is not recommended because of the potential for central nervous system-related side effects (see section 4.9).
Maltese: Kura ta 'tfal b'età minn sentejn 'il fuq (speċjalment dawk fil-firxa ta 'età ta '2-7 u/jew li jiżnu < 20 kg) mhux rakkomandata minħabba l-potenzjal ta 'effetti sekondarji relatati mas-sistema nervuża ċentrali (ara sezzjoni 4.9).
English: Clinical data on the use of SIMBRINZA adjunctive to prostaglandin analogues (PGA) also showed superior IOP-lowering efficacy of SIMBRINZA + PGA compared with the PGA alone.
Maltese: Data klinika dwar l-użu ta' SIMBRINZA flimkien ma' analogi ta' prostaglandin (PGA) uriet wkoll leffikaċja superjuri ta' SIMBRINZA + PGA biex inaqqsu l-IOP meta mqabbla mal-PGA biss.
English: Brinzolamide is primarily eliminated in urine unchanged.
Maltese: Brinzolamide huwa eliminat primarjament mhux mibdul fl-awrina.
English: -8.4 (n=394) -8.4 (n=384)
Maltese: -8.4 (n=384)
English: • Effects in the eye: allergic conjunctivitis (eye allergy), eye surface inflammation, eye pain, eye discomfort, blurred or abnormal vision, eye redness
Maltese: • Effetti fl-għajn: konġuntivite allerġika (allerġija fl-għajn), infjammazzjoni fis-superfiċje tal għajn, uġigħ fl-għajn, skonfort fl-għajn, vista mċajpra jew mhux normali, ħmura fl-għajn
English: Uncommon: apathy 2, depression
Maltese: Mhux komuni: apatija
English: The subjects experienced symptoms of CNS depression, typically temporary coma or low level of consciousness, lethargy, somnolence, hypotonia, bradycardia, hypothermia, pallor, respiratory depression and apnoea, and required admission to intensive care with intubation if indicated.
Maltese: L-individwi kellhom sintomi ta 'depressjoni tas-CNS, tipikament koma temporanja jew livell baxx ta 'koxjenza, letarġija, ngħas, ipotonija, bradikardija, ipotermja, ġilda pallida, depressjoni respiratorja u apnea, u ħtieġa ta 'dħul għall-kura intensiva b'intubazzjoni jekk indikat.
English: However, clinical and non-clinical safety data show it to be welltolerated and safe during chronic administration.
Maltese: Madankollu, dejta ta ' sigurtà klinika u mhux klinika turi li huwa ttollerat sew u sikur waqt għoti kroniku.
English: 2, frequent bowel movements
Maltese: 2, purgar frekwenti
English: Likewise, the steady-state plasma pharmacokinetics of brimonidine from the combination were similar to those observed for brimonidine administered alone, with the exception of the twice daily SIMBRINZA treatment group, for which the mean AUC0-12 hours was about 25% lower than that for brimonidine alone administered twice daily.
Maltese: B'mod simili, il-farmakokinetiċi fi stat fiss fil-plażma ta 'brimonidine mill-kombinazzjoni kienu simili għal dawk osservati għal brimonidine mogħti waħdu, bl-eċċezzjoni tal-grupp ta 'kura ta 'SIMBRINZA darbtejn kuljum, li għalih l-AUC0-12-il siegħa medja kienet madwar 25% inqas minn dik ta' brimonidine waħdu mogħti darbtejn kuljum.
English: Oral carbonic anhydrase inhibitors may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination (see section 4.4).
Maltese: Inibituri ta 'carbonic anhydrase li jittieħdu mill-ħalq jistgħu jnaqqsu l-ħila ta 'pazjenti anzjani li jwettqu attività li teħtieġ attenzjoni mentali u/jew koordinazzjoni fiżika (ara sezzjoni 4.4).
English: 1, pterygium 2, erythema of eyelid
Maltese: 2, ħmar il-lejlijiet
English: Caution is advised when using medicinal products such as antihypertensives and/or cardiac glycosides concomitantly with SIMBRINZA.
Maltese: Hija rakkomandata attenzjoni meta jintużaw prodotti mediċinali bħal sustanzi kontra lpressjoni għolja u/jew glycosides tal-qalb flimkien ma 'SIMBRINZA.
English: SIMBRINZA can be affected by alcohol.
Maltese: SIMBRINZA jista' jiġi affettwat mill-alkoħol.
English: In rabbits oral, maternally toxic doses of brinzolamide of up to 6 mg/kg/day (261 times the recommended daily clinical dose of 23 µg/kg/day) revealed no effect on foetal development.
Maltese: Fil-fniek dożi orali tossiċi għall-omm, ta 'brinzolamide sa 6 mg/kg/jum (261 darba d-doża klinika rakkomandata kuljum ta '23 µg/kg/jum) ma wrew l-ebda effett fuq l-iżvilupp tal-feti.
English: SIMBRINZA contains brinzolamide, a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically.
Maltese: SIMBRINZA fih brinzolamide, inibitur sulphonamide ta 'carbonic anhydrase, u għalkemm jingħata b'mod topiku, huwa assorbit sistemikament.
English: SIMBRINZA is not intended for use by children and adolescents aged below 18 years because it has not been studied in this age group.
Maltese: SIMBRINZA mhux maħsub sabiex jintuża fi tfal u adolexxenti li għandhom inqas minn 18-il sena minħabba li ma ġiex studjat f'dan il-grupp ta' età.
English: Caution is advised when initiating (or changing the dose of) concomitant systemic medicinal products (irrespective of pharmaceutical form) which may interact with α-adrenergic agonists or interfere with their activity, i.e. agonists or antagonists of the adrenergic receptor (e.g. isoprenaline, prazosin).
Maltese: Hija rakkomandata attenzjoni meta jinbdew (jew tinbidel id-doża ta') prodotti mediċinali sistemiċi flistess waqt (irrispettivament mill-forma farmaċewtika) li jistgħu jinteraġixxu ma 'agonisti αadrenerġiċi jew jinterferu mal-attività tagħhom, jiġifieri agonisti jew antagonisti tar-riċettur adrenerġiku (eż. isoprenaline, prazosin).
English: Mean IOP reductions from baseline at each time point at each visit with SIMBRINZA or the individual components administered concomitantly were similar (7 to 10 mmHg).
Maltese: It-tnaqqis medju fl-IOP mil-linja bażi f'kull punt ta 'ħin f'kull vista b'SIMBRINZA jew bilkomponenti individwali mogħtija flimkien kien simili (7 sa 10 mmHg).
English: -8.5 (n=384) -8.3 (n=373)
Maltese: -8.3 (n=373)
English: Oxidative cleavage of the imidazoline ring to 5-bromo-6-guanidinoquinoxaline is also observed.
Maltese: Qsim ossidattiv taċ-ċirku imidazoline għal 5-bromo-6-guanidinoquinoxaline huwa osservat ukoll.
English: However, caution is advised in patients taking medicinal products which can affect the metabolism and uptake of circulating amines (e.g. chlorpromazine, methylphenidate, reserpine, serotoninnorepinephrine reuptake inhibitors).
Maltese: Madankollu, hija rakkomandata attenzjoni f'pazjenti li jieħdu prodotti mediċinali li jistgħu jaffettwaw il-metaboliżmu u t-teħid ta 'amines fiċ-ċirkolazzjoni (eż. chlorpromazine, methylphenidate, reserpine, inibituri ta 'teħid mill-ġdid ta 'serotonin-norepinephrine).
English: Brinzolamide acts by inhibiting the enzyme carbonic anhydrase (CA-II) in the ciliary epithelium that reduces the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport across the ciliary epithelium, resulting in decreased aqueous humour formation.
Maltese: Brinzolamide jaħdem billi jinibixxi l-enzima carbonic anhydrase (CA-II) fl-epitelju ċiljari li jnaqqas ilformazzjoni ta 'joni ta 'bikarbonat bi tnaqqis sussegwenti fis-sodium u fit-trasport ta 'fluwidu minn ġol-epitelju ċiljari, li jwassal għal tnaqqis fil-formazzjoni tal-umur akweju.
English: -8.5 (n=384) -8.4 (n=377)
Maltese: -8.4 (n=377)
English: The systemic pharmacokinetics of brinzolamide and brimonidine, alone or in combination, in paediatric patients have not been studied.
Maltese: Il-farmakokinetika sistemika ta 'brinzolamide u brimonidine, waħedhom jew flimkien, ma ġietx studjata f'pazjenti pedjatriċi.
English: SIMBRINZA should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
Maltese: SIMBRINZA għandu jintuża b'attenzjoni f'pazjenti b'depressjoni, insuffiċjenza ċerebrali jew talkoronarji, fenomenu ta 'Raynaud, pressjoni ortostatika baxxa jew tromboanġite obliterans.
English: In contrast, brimonidine exhibits linear pharmacokinetics over the clinically therapeutic dose range.
Maltese: B'kuntrast ma' dan, brimonidine juri farmakokinetika lineari fuq il-firxa ta' doża klinika terapewtika.
English: Uncommon: nasopharyngitis
Maltese: Mhux komuni: uġigħ fid-dahar
English: • General side effects: tremor, decreased sensation, loss of taste, abnormal liver function values as seen in a blood test, swelling of the face, joint pain, frequent urination, chest pain, swelling of the extremities.
Maltese: • Effetti sekondarji ġenerali: rogħda, sensazzjoni mnaqqsa, telf tat-togħma, il-valuri tal-funzjoni tal-fwied mhux normali kif osservat f'test tad-demm, nefħa fil-wiċċ, uġigħ fil-ġogi, awrina frekwenti, uġigħ fis-sider, nefħa fl-estremitajiet.
English: Figure 1 Mean a diurnal (9 AM, +2 hrs, +7 hrs) IOP change from baseline (mmHg)Contribution of elements study aLeast squares means derived from a statistical model that accounts for study site, 9 AM baseline IOP stratum, and correlated IOP measurements within patient.
Maltese: Figura 1 Bidla medja a fl-IOP matul il-ġurnata (9 AM, +2 hrs, +7 hrs) mil-linja bażi (mmHg) - Studju dwar il-kontribuzzjoni tal-elementi