FrancophonIA/ELRC3.0 huggingface dataset:
English: The principal radioactive component in both plasma and faeces was ospemifene and the main metabolite 4hydroxyospemifene.
Maltese: Il-komponent prinċipali radjuattiv kemm fil-plażma kif ukoll fl-ippurgar kien ospemifene u l-metabolit prinċipali 4-hydroxyospemifene.
English: At these check-ups, discuss with your doctor the benefits and risks of continuing with Senshio.
Maltese: F'dawn iċ-check-ups, iddiskuti mat-tabib tiegħek il-benefiċċji u r-riskji li tkompli tieħu Senshio.
English: Trial 2 Dyspareunia
Maltese: Uġigħ waq l-att sesswali
English: Therefore, caution is recommended when co-administering ospemifene with fluconazole.
Maltese: It-tabib tiegħek jista' jikkunsidra li jwaqqaf ittrattament b'Senshio waqt li inti tkun qed tieħu fluconazole.
English: - Headache - Vaginal bleeding
Maltese: Tnixxija vaġinali, Tnixxija ġenitali, Emorraġija vaġinali
English: While taking Senshio:
Maltese: Kellem lit-tabib tiegħek qabel ma tieħu Senshio ma':
English: Ospemifene is absorbed rapidly after oral administration, with a Tmax of approximately 3 - 4 hours post-dose in the fed state.
Maltese: Ospemifene jiġi assorbit malajr wara l-għoti orali, b'Tmax ta' madwar 3 - 4 sigħat wara d-doża fl-istat mhux sajjem.
English: Name and address of the manufacturer(s) responsible for batch release Penn Pharmaceutical Services Ltd
Maltese: L-effetti ta' ospemifene fuq prodotti mediċinali oħrajn
English: MedDRA Preferred Term (v. 18.0)
Maltese: Terminu Ippreferut MedDRA (v. 18.0)
English: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Maltese: Alcon Cusi S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spanja.
English: 1, ptosis
Maltese: 1, ptosi
English: 3, alopecia
Maltese: 3, alopeċja
English: Clinical effects:
Maltese: Effetti kliniċi:
English: 3, bradycardia
Maltese: 3, bradikardija
English: B-2870 Puurs Belgium or
Maltese: B-2870 Puurs, Il-Belgium jew
English: One ml of suspension contains 0.10 mg benzalkonium chloride.
Maltese: Ml ta' suspensjoni fiha 0.10 mg benzalkonium chloride.
English: 2, rash
Maltese: 2, raxx
English: • Hypersensitivity to sulphonamides (see section 4.4).
Maltese: • Sensittività eċċessiva għal sulphonamides (ara sezzjoni 4.4).
English: Timolol metabolism is mediated primarily by CYP2D6.
Maltese: Il-metaboliżmu ta' timolol huwa medjat primarjament minn CYP2D6.
English: 2, apathy
Maltese: 2, apatija
English: , nervousness
Maltese: , nervi
English: 2, atrioventricular block
Maltese: 2, blokk atrijoventrikulari
English: At steady state, following administration of AZARGA, the mean plasma Cmax and AUC0-12h of timolol were 27% and 28% lower (Cmax: 0.824 ± 0.453 ng/ml; AUC0-12h: 4.71 ± 4.29 ng·h/ml), respectively, in comparison to the administration of timolol 5 mg/ml (Cmax: 1.13 ± 0.494 ng/ml; AUC0-12h: 6.58 ± 3.18 ng·h/ml).
Maltese: Fi stat fiss, wara għoti ta' AZARGA, Cmax u AUC0-12h medja fil-plażma ta' timolol kienu 27% u 28% inqas (Cmax: 0.824 ± 0.453 ng/ml; AUC0-12h: 4.71 ± 4.29 ng h/ml), rispettivament, meta mqabbel ma' lgħoti ta' timolol 5 mg/ml (Cmax: 1.13 ± 0.494 ng/ml; AUC0-12h: 6.58 ± 3.18 ng h/ml).
English: This medicine contains 3.34 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.
Maltese: Din il-mediċina fiha 3.34 µg ta' benzalkonium chloride f'kull qatra (= doża 1) li hu ekwivalenti għal 0.01% or 0.1 mg/ml.
English: • Hyperchloraemic acidosis (see section 4.2).
Maltese: • Aċidożi iperklorimika (ara sezzjoni 4.2).
English: 2, cardio-respiratory distress
Maltese: 2, distress kardjo-respiratorju
English: • Severe allergic rhinitis
Maltese: • Rinite allerġika severa
English: AZARGA contains brinzolamide, a sulphonamide.
Maltese: AZARGA fih brinzolamide, sustanza sulphonamide.
English: They are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Maltese: Huma kklassifikati skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1000), rari ħafna (<1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: White to off-white uniform suspension, pH 7.2 (approximately).
Maltese: Qtar għall-għajnejn, suspensjoni (qtar għall-għajnejn) Suspensjoni uniformi, bajda sa off-white, pH 7.2 (bejn wieħed u ieħor).
English: 2, increases in the signs and symptoms of myasthenia gravis
Maltese: 2, żieda fis-sinjali u s-sintomi ta' myasthenia gravis
English: AZARGA contains benzalkonium chloride
Maltese: AZARGA fih benzalkonium chloride
English: Nederland Novartis Pharma B.V. Tel: +31 26 37 82 111
Maltese: Novartis Pharma B.V. Tel: +31 26 37 82 111
English: , tachycardia
Maltese: , takikardija
English: Contains: benzalkonium chloride, mannitol (E421), carbopol 974P, tyloxapol, disodium edetate, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.
Maltese: Fih: benzalkonium chloride, mannitol (E421), carbopol 974P, tyloxapol, disodium edetate, sodium chloride, hydrochloric acid u/jew sodium hydroxide (għall-aġġustament tal-pH), ilma ippurifikat.
English: Rare: insomnia Not known: depression
Maltese: Rari: insomnja Mhux magħruf: depressjoni
English: • muscular weakness (myasthenia gravis)
Maltese: • dgħufija fil-muskoli (mijastenija gravis)
English: Potentiated systemic beta-blockade (e.g. decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.
Maltese: Imblokk sistemiku imsaħħaħ tar-riċetturi Beta (eż. rata tal-qalb imnaqqsa, depressjoni) kien irrapportat waqt kura kombinata b'inibituri ta' CYP2D6 (e.ż. quinidine, fluoxetine, paroxetine) u timolol.
English: Date of first Authorisation: 25 November 2008 Date of latest renewal: 26 August 2013
Maltese: Data tal-aħħar tiġdid: 26 Awwissu 2013
English: Pharmacodynamic effects
Maltese: Effetti farmkodinamiċi
English: It is expected that inhibitors of CYP3A4 such as ketoconazole, itraconazole, clotrimazole, ritonavir and troleandomycin will inhibit the metabolism of brinzolamide by CYP3A4.
Maltese: Huwa mistenni li inibituri ta' CYP3A4 bħal ketoconazole, itraconazole, clortrimazole, ritonavir u troleandomycin jinibixxu il-metaboliżmu ta' brinzolamide permezz ta' CYP3A4.
English: 3, paraesthesia
Maltese: 3, parasteżija
English: Hydrochloric acid and/or sodium hydroxide (for pH adjustment) Purified water
Maltese: Hydrochloric acid u/jew sodium hydroxide (għall-aġġustament tal-pH) Ilma ppurifikat
English: There is a potential for additive effects resulting in hypotension and/or marked bradycardia when an ophthalmic beta-blocker solution is administered concomitantly with oral calcium channel blockers, beta-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine.
Maltese: Hemm il-potenzjal għall-effetti addittivi li jirriżultaw fi pressjoni baxxa u/jew bradikardija qawwija meta soluzzjoni ta' imblokkatur tar-riċetturi beta għall-għajnejn tingħata flimkien ma' imblokkaturi orali tal-kanali tal-kalċju, sustanżi mblokkaturi beta-adrenerġiċi, anti-arritmiċi (inkluż amiodarone), digitalis glycosides, parasimpatomimetiċi, guanethidine.
English: Ear and labyrinth disorders Not known: vertigo
Maltese: Mhux magħruf: vertigo
English: • The other ingredients are benzalkonium chloride (see section 2 ‘AZARGA contains benzalkonium'), carbopol 974P, disodium edetate, mannitol (E421), purified water, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide.
Maltese: • Is-sustanzi l-oħra huma benzalkonium chloride (ara sezzjoni 2 ‘AZARGA fih benzalkonium'), carbopol 974P, disodium edetate, mannitol (E421), ilma ppurifikat, sodium chloride, tyloxapol, hydrochloric acid u/jew sodium hydroxide.
English: 3, hypoaesthesia
Maltese: 3, ipoesteżija
English: Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Maltese: Benzalkonium chloride kien irrappurtat ukoll li jikkawza keratopatija bil-ponot u/jew keratopatija ulċerattiva tossika.
English: Following twice daily dosing of AZARGA for 13 weeks, red blood cell (RBC) concentrations of brinzolamide averaged 18.8  3.29 µM, 18.1  2.68 µM and 18.4  3.01 µM at weeks 4, 10 and 15, respectively, indicating that steady-state RBC concentrations of brinzolamide were maintained
Maltese: Wara għoti darbtejn kuljum ta' AZARGA għal 13-il ġimgħa, konċentrazzjonijiet fiċ-ċelluli ħomor tad-demm (RBC) ta' brinzolamide kellhom medja ta' 18.8 3.29 µM, 18.1 2.68 µM u 18.4 3.01 µM f'ġimgħat 4, 10 u 15, rispettivament, u dan jindika li l-konċentrazzjonijiet fl-RBC fi stat fiss ta' brinzolamide kienu sostnuti.
English: 2, cerebrovascular accident syncope
Maltese: 2, inċident ċerebrovaskulari sinkope
English: • Brinzolamide and timolol are absorbed systemically.
Maltese: • Brinzolamide u timolol huma assorbiti b'mod sistemiku.
English: 3, epistaxis bronchial hyperactivity
Maltese: 1, iperattività tal-bronki
English: Brinzolamide and N-desethyl-brinzolamide are the predominant components found in the urine along with trace levels (<1%) of the N-desmethoxypropyl and O-desmethyl metabolites.
Maltese: Brinzolamide u N-desethyl-brinzolamide huma lkomponenti predominanti li jinstabu fl-awrina flimkien ma' livelli traċċa (<1%) tal-metaboliti
English: Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.
Maltese: Effetti gastro-intestinali, tas-sistema nervuża, ematoloġiċi, tal-kliewi u tal-metaboliżmu, ġeneralment huma assoċjati ma' inibituri sistemiċi ta' carbonic anhydrase.
English: Beta-adrenergic blocking medicinal products have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness).
Maltese: Prodotti mediċinali imblokkaturi beta-adrenerġiċi kienu irrappurtati li jaggravaw dgħufija fil-muskoli konsistenti ma' ċerti sintomi mijasteniċi (eż. diplopja, ptosi u dgħufija ġeneralizzata).
English: AZARGA contains two active substances: brinzolamide and timolol maleate.
Maltese: AZARGA fih żewġ sustanzi attiva: brinzolamide u timolol maleate.
English: Timolol is absorbed into the systemic circulation.
Maltese: Timolol jiġi assorbit fiċ-ċirkolazzjoni sistemika.
English: AZARGA contains brinzolamide which is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption.
Maltese: AZARGA fih brinzolamide, inibitur sulphonamide ta' carbonic anhydrase li huwa assorbit b'mod sistemiku.
English: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline.
Maltese: Preparazzjonijiet imblokkaturi tar-riċetturi beta għall-għajnejn jistgħu jimblokkaw effetti beta-agonisti sistemiċi eż. tal-adrenalina.
English: To reduce the systemic absorption, see section 4.2.
Maltese: Biex jitnaqqas lassorbiment sistemiku, ara sezzjoni 4.2.
English: Common: punctate keratitis
Maltese: Komuni: keratite bil-ponot
English: AZARGA may be used while wearing contact lenses with careful monitoring (see below under ‘Benzalkonium chloride').
Maltese: AZARGA jista' jintuża waqt li jintlibsu lentijiet tal-kuntatt b'monitoraġg b'attenzjoni (ara isfel taħ t ‘Benzalkonium chloride').
English: The plasma t1/2 of timolol is 4.8 hours after administration of AZARGA.
Maltese: It-t1/2 ta' timolol fil-plażma hija 4.8 sigħat wara l-għoti ta' AZARGA.
English: These could be the signs of an allergic reaction (frequency is not known).
Maltese: Dawn jistgħu jkunu sinjali ta' reazzjoni allerġika (frekwenza mhux magħrufa).
English: It could infect the drops.
Maltese: Infezzjonijiet u infestazzjonijiet
English: Tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Maltese: Jiġu miżjuda ammonti żgħar ta' hydrochloric acid u/jew sodium hydroxide biex il-livelli ta' aċidità (livelli tal-pH) jinżammu normali.
English: This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4).
Maltese: Dan jista' jwassal għal tnaqqis fl-effetti sekondarji sistemiċi u għal żjieda fl-attività lokali (ara sezzjoni 4.4).
English: Brinzolamide is eliminated primarily by renal excretion (approximately 60%).
Maltese: Brinzolamide huwa eliminat primarjament minn eskrezzjoni mill-kliewi (madwar 60%).
English: Not known: abnormal liver function test
Maltese: Mhux magħruf: test tal-funzjoni tal-fwied mhux normali
English: 3, visual impairment
Maltese: 3, indeboliment fil-vista
English: However, a risk to the suckling child cannot be excluded.
Maltese: Madankollu, riskju għat-tarbija li qed tiġi mredda' ma jistax jiġi eskluż.
English: 3, pollakiuria
Maltese: 3, pollakurja
English: Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Maltese: Disturbi fl-aċidi u l-bażi kienu irrapportati b'inibituri ta' carbonic anhydrase orali.
English: • Hypersensitivity to other beta-blockers.
Maltese: • Sensittività eċċessiva għall-imblokkaturi oħra tar-riċetturi beta.
English: - Keep this leaflet.
Maltese: Attenzjoni hija rrakkomandata.
English: AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension
Maltese: AZARGA 10 mg/ml + 5 mg/ml qtar għall-għajnejn, suspensjoni
English: 3, meibomianitis diplopia
Maltese: 2, konġuntivite meibomianitis
English: In a six-month, controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of AZARGA dosed twice daily was 7 to 9 mmHg, and was up to 3 mmHg greater than that of brinzolamide 10 mg/ml dosed twice daily and up to 2 mmHg greater than that of timolol 5 mg/ml dosed twice daily.
Maltese: Fi studju kliniku kkontrollat ta' sitt xhur f'pazjenti bi glawkoma open-angle jew pressjoni għolja ta' lgħajnejn u IOP medja fil-linja bażi ta' 25 sa 27 mmHg, il-medja tal-effett ta' tnaqqis fl-IOP ta' AZARGA mogħti darbtejn kuljum kien ta' 7 sa 9 mmHg, u kien sa 3 mmHg aktar minn dak ta' brinzolamide 10 mg/ml mogħti darbtejn kuljum u sa 2 mmHg aktar minn dak ta' timolol 5 mg/ml mogħti darbtejn kuljum.
English: 3, rhinitis
Maltese: 3, rinite
English: • Severe renal impairment.
Maltese: • Indeboliment sever tal-kliewi.
English: Not known: erectile dysfunction
Maltese: Mhux magħruf: disfunzjoni erettili
English: 1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate).
Maltese: 1 ml ta' suspensjoni fih 10 mg brinzolamide u 5 mg timolol (bħala timolol maleate).
English: 1, rhinorrhoea Not known: bronchospasm
Maltese: Mhux magħruf: bronkospażmu
English: Choroidal detachment
Maltese: Distakk korojdali
English: Pharmacotherapeutic group: Ophthalmologicals, Antiglaucoma preparation and miotics ATC code: S01ED51
Maltese: Oftalmoloġiċi, Preparazzjoni kontra l-glawkoma u mijotiċi Kodiċi ATC:
English: AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension brinzolamide/timolol
Maltese: AZARGA 10 mg/ml + 5 mg/ml qtar għall-għajnejn, suspensjoni brinzolamide/timolol
English: • Nervous system and general disorders: depression, nightmares, memory loss, headache, nervousness, irritability, tiredness, shaking, feeling abnormal, fainting, dizziness, drowsiness, generalised or severe weakness, unusual sensations like pins and needles.
Maltese: • Disturbi fis-sistema nervuża u ġenerali: depressjoni, inkubi, telf tal-memorja, uġigħ ta' ras, nervi, irritabilità, għeja, tregħid, tħossok mhux normali, ħass ħażin, sturdament, ħedla ta' ngħas, debbulizza ġeneralizzata jew severa, sensazzjonijiet mhux tas-soltu bħal tingiż.
English: Nervous system disorders Common: dysgeusia Not known: cerebral ischaemia
Maltese: Komuni: disġewżja Mhux magħruf: iskemija ċerebrali
English: Hypoglycaemia/diabetes
Maltese: Ipogliċemija/dijabete
English: Not known (frequency cannot be estimated from the available data)
Maltese: Mhux magħrufa (frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: • overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease
Maltese: • attività żejda tal-glandola tat-tirojde peress li timolol jista' jgħatti sinjali u sintomi ta' marda tat-tirojde
English: • Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker.
Maltese: • Sinus bradikardja, sindrome ta' sinus marid, blokk sino-atrijali, blokk atrijoventrikolari tat-tieni jew tat-tielet grad mhux ikkontrolalt b'pace-maker.
English: What AZARGA looks like and contents of the pack AZARGA is a liquid (white to off-white uniform suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap or in a pack containing three 5 ml bottles.
Maltese: AZARGA huwa likwidu (suspensjoni uniform ta' kulur abjad sa off-white) fornuta f'pakkett li fih flixkun tal-plastik wieħed ta' 5 ml b'għatu bil-kamin jew f'pakkett li fih 3 fliexken ta' 5 ml.
English: • If you have severe kidney problems.
Maltese: • Jekk għandek problemi severi tal-kliewi.
English: In vitro studies show that the metabolism of brinzolamide mainly involves CYP3A4 as well as at least four other isozymes (CYP2A6, CYP2B6, CYP2C8 and CYP2C9).
Maltese: Studji in vitro juru li l-metaboliżmu ta' brinzolamide jinvolvi prinċipalment lil CYP3A4 kif ukoll ta' l-inqas erba' isożimi oħra (CYP2A6, CYP2B6, CYP2C8 u CYP2C9).
English: 3, corneal oedema decreased corneal sensitivity
Maltese: 3, tnaqqis fis-sensittività tal-kornea
English: In a twelve-month, controlled clinical trial in patients with open-angle glaucoma or ocular hypertension who, in the investigator's opinion could benefit from a combination therapy, and who had baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of AZARGA dosed twice daily was 7 to 9 mmHg.
Maltese: Fi prova klinika kkontrollata ta' tnax il-xahar, f'pazjenti bi glawkoma open-angle jew pressjoni għolja ta' l-għajnejn li fl-opinjoni ta' l-investigatur setgħu jibbenefikaw minn terapija kombinata, u li kellhom IOP medja fil-linja bażi ta' 25 sa 27 mmHg, il-medja tal-effett ta' tnaqqis fl-IOP ta' AZARGA mogħti darbtejn kuljum kien ta' 7 sa 9 mmHg.
English: About 20% of the dose has been accounted for in urine as metabolite.
Maltese: Madwar 20% tad-doża nstabet fl-awrina bħala metabolit.
English: Not known: myalgia
Maltese: Mhux magħruf: majalġja
English: If you are using other eye drop or eye ointment medicines leave at least 5 minutes between each medicine.
Maltese: Jekk qed tuża mediċini oħra ta' qtar jew ingwent għall-għajnejn ħalli mill-anqas 5 minuti bejn kull mediċina.
English: 1, systemic allergic reactions including angioedema,
Maltese: 1, reazzjonijiet allerġiċi sistemiċi li jinkludu anġjoedima
English: In clinical trials, the most common adverse reactions were blurred vision, eye irritation and eye pain, occurring in approximately 2% to 7% of patients.
Maltese: Fi provi kliniċi, l-aktar reazzjonijiet avversi komuni kienu vista mċajpra, irritazzjoni fl-għajnejn u uġigħ fl-għajnejn, li jseħħu f'madwar 2% sa 7% tal-pazjenti.
English: CARTON FOR SINGLE BOTTLE 5 ml + CARTON FOR 3 x 5 ml BOTTLES
Maltese: KARTUNA GĦALL-FLIXKUN WIEĦED TA' 5 ml + KARTUNA GĦAL 3 FLIEXKEN TA' 5 ml
English: Following administration of AZARGA, mean Cmax of timolol was reached at 0.79 ± 0.45 hours.
Maltese: Wara għoti ta' AZARGA, Cmax medja ta' timolol intlaħqet fi żmien 0.79 ± 0.45 sigħat.
English: 3, madarosis
Maltese: 2, dijarea
English: AZARGA 10 mg/ml + 5 mg/ml eye drops brinzolamide/timolol Ocular use
Maltese: AZARGA 10 mg/ml + 5 mg/ml qtar għall-għajnejn brinzolamide/timolol
English: The safety and efficacy of AZARGA in children and adolescents aged 0 to 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' AZARGA fit-tfal u l-adolexxenti b'età minn 0 sa 18-il sena ma ġewx determinati s'issa.
English: 3, gastrointestinal disorder
Maltese: Disturbi gastro-intestinali
English: In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery.
Maltese: Barra dan, sinjali u sintomi ta' imblokk tar-riċetturi beta (eż. bradikardja, pressjoni baxxa, distress respiratorju u ipogliċemija) kienu osservati fi tarbi tat-twelid meta imblokkaturi tar-riċetturi beta ngħataw sal-ħlas.
English: • poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome)
Maltese: • marda ta' ċirkolazzjoni ħażina tad-demm (bħal marda ta' Raynaud jew sindrome ta' Raynaud)
English: Overt cardiac failure, cardiogenic shock.
Maltese: Insuffiċjenza kardijaka ċara, xokk kardjoġeniku.
English: Not known: urticaria 3, maculo-papular rash
Maltese: 3, raxx makulo-papulari
English: 3, nightmare
Maltese: 3, sinożite
English: • if you have liver problems.
Maltese: • jekk għandek problemi fil-kliewi tiegħek.
English: Epidemiological studies have not revealed malformative effects but show a risk for intra uterine growth retardation when beta-blockers are administered by the oral route.
Maltese: Studji epidemjoloġiċi ma kixfu l-ebda effetti malformattivi iżda juru riskju ta' ttardjar tat-tkabbir flutru meta imblokkakturi beta jingħataw permezz tar-rotta orali.
English: Similar studies in rats resulted in slightly reduced ossification of skull and sternebrae of foetuses of dams receiving brinzolamide at doses of 18 mg/kg/day (642 times the recommended daily clinical dose), but not 6 mg/kg/day.
Maltese: Studji simili fil-firien wasslu għal tnaqqis żgħir fl-ossifikazzjoni tal-għadam tar-ras u ta' l-isternebrae tal-feti ta' ommijiet li rċevew brinzolamide b'dożi ta' 18 mg/kg/kuljum (642 darba d-doża klinika rrakkomandata kuljum), iżda mhux b'6 mg/kg/kuljum.
English: 1, erythema
Maltese: 1, rinorea
English: 3, eyelid oedema
Maltese: 3, ħmar il-lejl
English: In three controlled clinical trials, the ocular discomfort upon instillation of AZARGA was significantly lower than that of dorzolamide 20 mg/ml + timolol 5 mg/ml.
Maltese: Fi tliet provi kliniċi kkontrollati, l-iskomdu fl-għajn mat-tqattir ta' AZARGA kien sinifikatament aktar baxx minn dak ta' dorzolamide 20 mg/ml + timolol 5 mg/ml.
English: Dose-related decreases in foetal weights were observed in pups of dams receiving brinzolamide orally ranging from a slight decrease (about 5-6%) at 2 mg/kg/day to nearly 14% at 18 mg/kg/day.
Maltese: Fi friegħ ta' ommijiet li rċevew brinzolamide mill-ħalq, kien osservat tnaqqis relatat mad-doża fil-piż tal-fetu li varja minn tnaqqis żgħir (madwar 5-6%) b'doża ta' 2 mg/kg/kuljum sa kważi 14% b'doża ta' 18 mg/kg/kuljum.
English: • breathing problems, asthma or chronic obstructive pulmonary disease
Maltese: • problemi fin-nifs, ażżma jew marda ostruttiva kronika tal-pulmun
English: Reproduction toxicity studies with timolol showed delayed foetal ossification in rats with no adverse effects on postnatal development (at 50 mg/kg/day or 3,500 times the daily clinical dose of 14 g/kg/day) and increased foetal resorptions in rabbits (at 90 mg/kg/day or 6,400 times the daily clinical dose).
Maltese: Studji dwar it-tossiċità fuq is-sistema riproduttiva b'timolol urew ossifikazzjoni ttardjata tal-fetu fil-firien bl-ebda effetti avversi fuq l-iżvilupp wara t-twelid (b'50 mg/kg/kuljum jew 3500 darba d-doża klinika rrakkomandata kuljum ta' 14 g/kg/kuljum) u żjieda fl-assorbiment millġdid tal-fetu fil-fniek (b'90 mg/kg/kuljum jew 6400 darba d-doża klinika ta' kuljum).
English: 1, memory loss
Maltese: 1, telf ta' memorja
English: AZARGA has not been studied in patients with severe renal impairment (creatinine clearance <30 ml/min) or in patients with hyperchloraemic acidosis (see section 4.3).
Maltese: AZARGA ma' ġiex studjat f'pazjenti b'indeboliment serju tal-kliewi (tneħħija tal-krejatinina ta' <30 ml/min) jew f'pazjenti li għandhom aċidożi iperklorimika (ara sezzjoni 4.3).
English: Due to the beta-adrenergic blocking component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur.
Maltese: Minħabba l-komponent imblokkatur beta-adrenerġiku, timolol, jista' jkun hemm l-istess tipi ta' reazzjonijiet avversi kardovaskulari, pulmonari u oħrajn osservati b'sustanzi imblokkaturi beta-adrenerġiċi sistemiċi.