FrancophonIA/ELRC3.0 huggingface dataset:
English: In a laboratory study, the product was well tolerated in dogs with a deficient multidrug-resistanceprotein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose.
Maltese: Fi studju fil-laboratorju, il-prodott kien ittollerat sew fi klieb b'defiċjenza fil-multidrug-resistanceprotein 1 (MDR1 -/-) wara doża waħda amministrata fil-ħalq f'doża 3 darbiet aktar minn dik rakkomandata.
English: Sarolaner binding to these receptors prevents the uptake of chloride ions by GABA and glutamate gated ion channels, thus resulting in increased nerve stimulation and death of the target parasite.
Maltese: L-abbinar tas-sarolaner ma' dawn ir-reċetturi ifixkel il-moviment tal-ijoni tal-kloru mill-GABA u l-glutamate-gated ion channels, u dan iwassal għal żieda fl-istimulazzjoni tan-nervituri u l-mewt tal-parassiti mmirati.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Metodu ta' amministrazzjoni
English: The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors).
Maltese: Il-mira primarja tal-azzjoni ta' sarolaner fl-insetti u l-akkaridi hija l-blokk funzjonali tal-ligand-gated chloride channels (ReċetturiGABA u reċetturi-glutamate).
English: This results in flaccid paralysis and eventual death of parasites exposed to the drug.
Maltese: Dan iwassal għal telqa paralitika u fl-aħħar mewt tal-parassiti esposti għall-mediċina.
English: Treatment schedule:
Maltese: Skeda tat-trattament
English: Simparica Trio chewable tablets for dogs 1.25-2.5 kg Simparica Trio chewable tablets for dogs >2.5-5 kg Simparica Trio chewable tablets for dogs >5-10 kg Simparica Trio chewable tablets for dogs >10-20 kg Simparica Trio chewable tablets for dogs >20-40 kg Simparica Trio chewable tablets for dogs >40-60 kg
Maltese: Trio pilloli li jintmagħdu għal klieb >2.5-5 kg Simparica Trio pilloli li jintmagħdu għal klieb >5-10 kg Simparica Trio pilloli li jintmagħdu għal klieb >10-20 kg Simparica Trio pilloli li jintmagħdu għal klieb >20-40 kg Simparica Trio pilloli li jintmagħdu għal klieb >40-60 kg
English: None known.
Maltese: Nematodi oħra
English: Other nematodes
Maltese: PARIR SABIEX
English: Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Maltese: Artikolu 31 tad-Direttiva 2001/83/KE kif emendat, referenza fl-interess Komunitarju.
English: Ref. EMEA/727399/2009 rev. EMEA/H/A-31/1097
Maltese: EMEA/H/A-31/1097
English: 2 Article 20 of Regulation (EC) No 726/2004.
Maltese: 2 Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: The review was carried out under ‘Article 31'1 and ‘Article 20'2 referrals.
Maltese: Ir-reviżjoni saret skont referenzi tal-‘Artikolu 31'1 u l-‘Artikolu 20'2.
English: London, 1 July 2010 Doc.
Maltese: Londra, l-1 ta' Lulju 2010
English: Gadolinium-containing contrast agents include nine different active substances: gadobenic acid, gadobutrol, gadodiamide, gadofosveset, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Maltese: Is-sustanzi ta' kuntrast li fihom il-gadolinju jinkludu disa' sustanzi attivi differenti: aċidu gadobeniku, gadobutrol, gadodiamide, gadofosveset, aċidu gadopentetiku, aċidu gadoteriku, gadoteridol, gadoversetamide u aċidu gadoksetiku.
English: • low risk: gadoteric acid (Dotarem), gadoteridol (ProHance) and gadobutrol (Gadovist).
Maltese: • ta' riskju baxx: aċidu gadoteriku (Dotarem), gadoteridol (ProHance) u gadobutrol (Gadovist).
English: • information on the cases of NSF reported for each agent.
Maltese: • informazzjoni dwar il-każijiet ta' NSF irrappurtati għal kull sustanza.
English: • medium risk: gadofosveset (Vasovist), gadoxetic acid (Primovist) and gadobenic acid
Maltese: • ta' riskju medju: gadofosveset (Vasovist), aċidu gadoksetiku (Primovist) u aċidu gadobeniku
English: • high risk: gadoversetamide (OptiMARK), gadodiamide (Omniscan) and gadopentetic acid
Maltese: • ta' riskju għoli: gadoversetamide (OptiMARK), gadodiamide (Omniscan) u aċidu gadopentetiku (Magnevist, Magnegita, u Gado-MRT-ratiopharm);
English: For medium- and low-risk agents the CHMP recommended that:
Maltese: Fil-każ tas-sustanzi ta' riskju medju u baxx is-CHMP irrakkomanda li:
English: Two of these products - OptiMARK (gadoversetamide) and Vasovist (gadofosveset) - have received a marketing authorisation that is valid throughout the European Union (EU).
Maltese: Tnejn minn dawn il-prodottiOptiMARK (gadoversetamide) u Vasovist (gadofosveset) - irċevew awtorizzazzjoni għat-tqegħid fissuq li hija valida fl-Unjoni Ewropea (UE).
English: The European Medicines Agency has completed a review of the risk of nephrogenic systemic fibrosis (NSF) in patients receiving gadolinium-containing contrast agents.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni tar-riskju ta' fibrożi sistemika nefroġenika (nephrogenic systemic fibrosis - NSF) f'pazjenti li jkunu qegħdin jingħataw sustanzi ta' kuntrast li fihom il-gadolinju.
English: In December 2007, the Scientific Advisory Group (SAG) for Diagnostics of the CHMP was convened to discuss the approach of the PhVWP.
Maltese: F'Diċembru 2007, issejjaħ il-Grupp Xjentifiku Konsultattiv (SAG) għad-Dijanjostika tas-CHMP sabiex jiddiskuti l-approċċ tal-PhVWP.
English: Consequently, in November 2008 the Danish medicines regulatory agency asked the CHMP to carry out an assessment of the risk of NSF for the non-centrally authorised gadolinium-containing contrast agents, and to recommend measures that could be taken to reduce this risk.
Maltese: Għalhekk, f'Novembru 2008 l-aġenzija regolatorja tal-mediċini Daniża talbet lis-CHMP sabiex jagħmel evalwazzjoni tar-riskju ta' NSF għas-sustanzi ta' kuntrast li fihom il-gadolinju li mhumiex awtorizzati ċentralment, u sabiex jirrakkomanda miżuri li jistgħu jittieħdu sabiex jitnaqqas dan irriskju.
English: • their dose should be restricted to the minimum recommended dose in patients with moderate kidney problems and infants up to one year of age, and there should be at least a period of seven days between scans;
Maltese: • id-doża tagħhom għandha tkun limitata għad-doża minima rrakkomandata f'pazjenti bi problemi moderati tal-kliewi u fit-trabi sa sena, u għandu jkun hemm mill-inqas perijodu ta' sebat ijiem bejn skan u ieħor;
English: However, the CHMP recognised that within the high-risk group the risk of NSF with gadoversetamide and gadodiamide appears higher than with gadopentetic acid, based on physicochemical properties, studies in animals and the number of cases of NSF reported worldwide.
Maltese: Madankollu, is-CHMP irrikonoxxa li fil-grupp ta' riskju għoli r-riskju ta' NSF b'gadoversetamide u gadodiamide jidher li huwa akbar milli bl-aċidu gadopentetiku, abbażi ta' proprjetajiet fiżikokimiċi, studji fl-annimali u lgħadd ta' każijiet ta' NSF irrappurtati fid-dinja kollha.
English: • screening for kidney problems using laboratory tests is recommended for all patients before receiving these agents.
Maltese: • l-iskrining għal problemi tal-kliewi permezz ta' testijiet fil-laboratorju huwa rrakkomandat għall-pazjenti kollha qabel ma jingħataw dawn is-sustanzi.
English: • as a precaution, breastfeeding should be discontinued for at least 24 hours after the patient has received a high-risk agent;
Maltese: • bħala prekawzjoni, it-treddigħ għandu jitwaqqaf għal mill-inqas 24 siegħa wara li l-pazjenta tkun ingħatat sustanza ta' riskju għoli;
English: To minimise the risk of NSF the Committee recommended a number of changes to the prescribing information of these medicines, depending on the risk classification of the agents.
Maltese: Biex jitnaqqas ir-riskju ta' NSF, il-Kumitat irrakkomanda għadd ta' bidliet fl-informazzjoni talpreskrizzjoni ta' dawn il-mediċini, skont il-klassifikazzjoni tar-riskju ta' dawn is-sustanzi.
English: • a statement that there is no evidence to support the initiation of haemodialysis (a blood clearance technique) to prevent or treat NSF in patients not already undergoing haemodialysis;
Maltese: • dikjarazzjoni li m'hemm l-ebda evidenza li tappoġġja l-bidu ta' emodijalisi (teknika ta' tneħħija tad-demm) sabiex tiġi evitata jew trattata l-NSF f'pazjenti li ma jkunux diġà qegħdin jingħataw emodijalisi;
English: An association between the use of gadolinium-containing contrast agents and NSF was first observed in January 2006, when cases of the disease were reported in Denmark and Austria in patients with kidney problems undergoing MRI scans.
Maltese: Assoċjazzjoni bejn l-użu ta' sustanzi ta' kuntrast li fihom il-gadolinju u l-NSF ġiet osservata għallewwel darba f'Jannar 2006, meta każijiet tal-marda ġew irrapportati fid-Danimarka u fl-Awstrija f'pazjenti bi problemi tal-kliewi li kienu qegħdin isirulhom skans tal-MRI. L-NSF hija marda rari li tikkawża t-tħaxxin tal-ġilda u tat-tessuti konnettivi f'pazjenti bi problemi severi tal-kliewi.
English: • a warning that the elderly may be at particular risk of NSF, because their kidneys are less able to remove gadolinium from the body;
Maltese: • twissija li l-anzjani jistgħu jkunu f'riskju partikolari ta' NSF, minħabba li l-kliewi tagħhom huma inqas kapaċi li jneħħu l-gadolinju mill-ġisem;
English: • their dose should be restricted to the minimum recommended dose in patients with severe kidney problems, patients around the time of liver transplantation and neonates and infants up to one year of age, and there should be at least a period of seven days between scans;
Maltese: • id-doża tagħhom għandha tkun limitata għad-doża minima rrakkomandata f'pazjenti bi problemi severi tal-kliewi, f'pazjenti li dalwaqt ikun ser isirilhom trapjant tal-fwied u fit-trabi tat-twelid u trabi sa sena, u għandu jkun hemm mill-inqas perijodu ta' sebat ijiem bejn skan u ieħor;
English: • Gadolinium-containing contrast agents remain suitable diagnostic agents for use in patients undergoing an MRI scan, but doctors should be aware of the associated risk of NSF especially in patients with kidney problems, and other high-risk groups.
Maltese: Din kienet tinkludi informazzjoni minn studji prekliniċi u kliniċi, kif ukoll informazzjoni pprovduta minn kumpaniji li jagħmlu l-mediċini.
English: • all patients should be screened for kidney problems using laboratory tests before receiving these agents.
Maltese: • il-pazjenti kollha għandhom ikunu skrinjati għal problemi tal-kliewi permezz ta' testijiet fillaboratorju qabel ma jingħataw dawn is-sustanzi.
English: It may affect several organs such as the liver, lungs and heart.
Maltese: Tista' taffettwa diversi organi bħall-fwied, il-pulmun u l-qalb.
English: During 2007, more cases of the disease were reported and the CHMP's Pharmacovigilance Working Party (PhVWP) held several discussions to establish how the risk of NSF could be reduced.
Maltese: Matul l-2007, ġew irrappurtati aktar każijiet tal-marda u l-Grupp ta' Ħidma tal-Farmakoviġilanza (PhVWP) tas-CHMP għamel bosta diskussjonijiet sabiex jistabbilixxi kif jista' jitnaqqas ir-riskju ta' NSF.
English: Finally, the CHMP recommended that further studies should be carried out on the long-term retention of gadolinium in human tissues (such as bone) released from gadolinium-containing contrast agents.
Maltese: Finalment, is-CHMP irrakkomanda li jsiru aktar studji dwar iż-żamma fit-tul ta' gadolinju fit-tessuti umani (bħall-għadam) rilaxxat minn sustanzi ta' kuntrast li fihom il-gadolinju.
English: The CHMP has assessed all of the available information on the risks of NSF associated with the use of gadolinium-containing contrast agents, particularly those used in patients with kidney problems and patients receiving a liver transplant, in neonates and infants, the elderly and women who are pregnant or breastfeeding.
Maltese: Is-CHMP evalwa l-informazzjoni kollha disponibbli dwar ir-riskji ta' NSF assoċjati mal-użu ta' sustanzi ta' kuntrast li fihom il-gadolinju, b'mod partikolari dawk użati f'pazjenti bi problemi talkliewi u f'pazjenti li jkun qed isirilhom trapjant tal-fwied, fit-trabi u fit-tfal żgħar, l-anzjani u n-nisa tqal jew li jkunu qegħdin ireddgħu.
English: (95% CI)
Maltese: (CI ta '95%)
English: 1, motor dysfunction
Maltese: 1,disfunzjoni motorja
English: Linearity/non-linearity
Maltese: Linearità/nuqqas ta 'linearità
English: Brinzolamide + Brimonidine Mean a
Maltese: Brinzolamide + Brimonidine Medja a
English: 3, dermatitis
Maltese: 3, dermatite
English: 2, alopecia
Maltese: 2, alopeċja
English: 6.1 List of excipients
Maltese: 6.1 Lista ta 'eċċipjenti
English: clomipramine, mianserin, venlafaxine and duloxetine - anaesthetics - sedatives, opiates, or barbiturates
Maltese: clomipramine, mianserin, venlafaxine u duloxetine - anaestetiċi - sedattivi, opiates, jew barbiturates
English: Uncommon: vertigo
Maltese: Mhux komuni: vertigo
English: Uncommon: cardio-respiratory distress
Maltese: Mhux komuni: distress kardjo-respiratorju
English: 1 x 5 ml 3 x 5 ml
Maltese: 3 x 5 ml
English: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Barcelona Spain
Maltese: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Barcelona Spanja
English: Manufacturer Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Spain
Maltese: Manifattur Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Spanja
English: Difference Mean a
Maltese: Differenza Medja a
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta 'eċċipjenti, ara sezzjoni 6.1.
English: Hypersensitivity to sulphonamides (see section 4.4).
Maltese: Sensittività eċċessiva għal sulphonamides (ara sezzjoni 4.4).
English: See leaflet for further information.
Maltese: Sorsi oħra ta 'informazzjoni
English: 2, nervousness
Maltese: 2, nervi
English: All treatment differences (SIMBRINZA versus individual components) were statistically significant with p=0.0001 or less.
Maltese: Differenzi kollha tal-kura (SIMBRINZA kontra komponenti individwali) kienu statistikament sinifikanti b'p=0.0001 jew inqas.
English: 1, urticaria
Maltese: 1, urtikarja
English: SIMBRINZA Mean a
Maltese: SIMBRINZA Medja a
English: BE-2870 Puurs Belgium or
Maltese: BE-2870 Puurs Il-Belġju jew
English: Brimonidine is primarily eliminated in the urine as metabolites.
Maltese: Brimonidine huwa eliminat primarjament fl-awrina bħala metaboliti.
English: Benzalkonium chloride, propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.
Maltese: Benzalkonium chloride, propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid u/jew sodium hydroxide (għall-aġġustament tal-pH) u ilma ppurifikat.
English: Each mL of suspension contains 0.03 mg of benzalkonium chloride.
Maltese: Kull mL ta 'suspensjoni fih 0.03 mg ta 'benzalkonium chloride.
English: Very rare: uveitis
Maltese: Rari ħafna: uveite
English: They are classified according to the subsequent convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data).
Maltese: Huma kklassifikati skont il-konvenzjoni sussegwenti: komuni ħafna ( ≥ 1/10), komuni ( ≥1/100 sa <1/10), mhux komuni ( ≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (≤1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Brinzolamide is moderately (about 60%) bound to human plasma proteins.
Maltese: Brinzolamide huwa marbut b'mod moderat (madwar 60%) ma' proteini fil-plażma umana.
English: • General side effects: decreased blood pressure, chest pain, irregular heartbeat, slow or fast heart rate, palpitations, difficulty sleeping (insomnia), nightmares, depression, generalised weakness, headache, dizziness, nervousness, irritability, general feeling of being unwell, memory loss, shortness of breath, asthma, nose bleeds, cold symptoms, dry nose or throat, sore throat, throat irritation, cough, runny nose, stuffy nose, sneezing, sinus infection, chest congestion, ringing in ear, indigestion, intestinal gas or stomach ache, nausea, diarrhoea, vomiting, abnormal sensation in mouth, increased allergic symptoms on skin, rash, abnormal skin sensation, hair loss, generalised itching, increased blood chlorine levels, or decreased red blood cell count as seen in a blood test, pain, back pain, muscle pain or spasm, kidney pain such as lower back pain, decreased libido, male sexual difficulty.
Maltese: • Effetti sekondarji ġenerali: tnaqqis fil-pressjoni tad-demm, uġigħ fis-sider, taħbit tal-qalb irregolari, rata tal-qalb baxxa jew mgħaġġla, palpitazzjonijiet, diffikultà biex torqod (insomnja), inkubi, depressjoni, dgħufija ġeneralizzata, uġigħ ta 'ras, sturdament, nervi, irritabilità, sensazzjoni ġenerali li ma tiflaħx, telf ta 'memorja, qtugħ ta' nifs, ażżma, tinfaraġ, sintomi ta ' riħ, imnieħer jew griżmejn xotti, uġigħ fil-griżmejn, irritazzjoni fil-griżmejn, sogħla, imnieħer inixxi, imnieħer misdud, għatis, infezzjoni fis-sinus, konġestjoni fis-sider, tisfir fil-widnejn, indiġestjoni, gass fl-imsaren jew uġigħ fl-istonku, dardir, dijarea, rimettar, sensazzjoni mhux normali fil-ħalq, żieda fis-sintomi allerġiċi tal-ġilda, raxx, sensazzjoni mhux normali tal-ġilda, telf ta 'xagħar, ħakk ġeneralizzat, żieda fil-livelli ta' chlorine fid-demm, jew tnaqqis fl-għadd ta' ċelluli ħomor tad-demm kif osservat f'test tad-demm, uġigħ, uġigħ fid-dahar, uġigħ fil-muskoli jew spażmu, uġigħ fil-kliewi bħal uġigħ fil-parti t'isfel tad-dahar, tnaqqis fil-libido, diffikultà sesswali fl-irġiel.
English: All subjects were reported to have made a full recovery, usually within 6-24 hours.
Maltese: L-individwi kollha kienu rrappurtati li għamlu rkupru sħiħ, normalment fi żmien 6-24 siegħa.
English: 2, peripheral oedema adverse reaction observed with SIMBRINZA 2 additional adverse reaction observed with brinzolamide monotherapy additional adverse reaction observed with brimonidine monotherapy
Maltese: 2, edima periferali reazzjoni avversa osservata b'SIMBRINZA reazzjoni avversa addizzjonali osservata b'monoterapija ta 'brinzolamide reazzjoni avversa addizzjonali osservata b'monoterapija ta 'brimonidine
English: Brinzolamide is metabolised by hepatic cytochrome P450 isozymes, specifically CYP3A4, CYP2A6, CYP2B6, CYP2C8 and CYP2C9.
Maltese: Brinzolamide huwa metabolizzat minn isozimi taċ-ċitokromju P450 tal-fwied, speċifikament CYP3A4, CYP2A6, CYP2B6, CYP2C8 u CYP2C9.
English: 1, photopsia
Maltese: 1, fotofobija
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 l-metaboliżmu ta ' brinzolamide permezz ta 'CYP3A4.
English: Alcon-Couvreur N.V. Rijksweg 14
Maltese: Alcon-Couvreur N.V.
English: , heart rate irregular
Maltese: , rata tal-qalb irregolari
English: Mean percent IOP reductions from baseline with SIMBRINZA ranged from 23 to 34%.
Maltese: Tnaqqis perċentwali medju fl-IOP mil-linja bażi b'SIMBRINZA varja minn 23 sa 34%.
English: Brimonidine is extensively metabolised by hepatic aldehyde oxidase, with formation of 2oxobrimonidine, 3-oxobrimonidine and 2,3-dioxobrimonidine being the major metabolites.
Maltese: Brimonidine huwa metabolizzat b'mod estensiv permezz ta' aldehyde oxidase tal-fwied, bilformazzjoni ta '2-oxobrimonidine, 3-oxobrimonidine u 2,3-dioxobrimonidine jkunu l-metaboliti ewlenin.
English: 1 ml of suspension contains 10 mg brinzolamide and 2 mg brimonidine tartrate.
Maltese: 1 ml ta 'suspensjoni fih 10 mg brinzolamide u 2 mg brimonidine tartrate.
English: Wearing contact lenses - SIMBRINZA contains benzalkonium chloride
Maltese: Użu ta' lentijiet tal-kuntatt - SIMBRINZA fih benzalkonium chloride
English: - The other ingredients are benzalkonium chloride (see section 2 “Wearing contact lensesSIMBRINZA contains benzalkonium chloride”), propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide and purified water.
Maltese: - Is-sustanzi l-oħra huma benzalkonium chloride (ara sezzjoni 2 ‘Użu ta' lentijiet tal-kuntattSIMBRINZA fih benzalkonium chloride'), propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid u/jew sodium hydroxide u ilma ppurifikat.
English: Alpha adrenergic agonists (e.g. brimonidine tartrate), as a class, may reduce pulse and blood pressure.
Maltese: Agonisti alfa adrenerġiċi (eż., brimonidine tartrate), bħala klassi, jistgħu jnaqqsu l-polz u l-pressjoni tad-demm.
English: Hydrochloric acid and/or sodium hydroxide (to adjust pH) Purified water
Maltese: Hydrochloric acid u/jew sodium hydroxide (għall-aġġustament tal-pH) Ilma ppurifikat
English: Manufacturer Alcon-Couvreur N.V. Rijksweg 14
Maltese: Manifattur Alcon-Couvreur N.V.
English: Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Maltese: Disturbi fl-aċidità-alkalinità ġew irrappurtati b'inibituri ta 'carbonic anhydrase orali.
English: 2, myalgia
Maltese: 2, mijalġja
English: The Cmax, AUC and elimination half-life of brimonidine are similar in elderly (>65 years of age) subjects compared to young adults.
Maltese: Is-Cmax, l-AUC u l-half-life tal-eliminazzjoni ta 'brimonidine huma simili f'individwi anzjani (età ta ' >65 sena) meta mqabbla ma 'adulti żgħażagħ.
English: In study CQVJ499A2402, SIMBRINZA + travoprost-timolol maleate eye drops demonstrated superior IOPlowering efficacy from baseline compared to Vehicle + travoprost-timolol maleate eye drops after 6 weeks of treatment, with between-treatment difference in model-adjusted mean change from baseline in diurnal IOP of -2.15 mmHg (95% CI, -2.8, -1.5; p-value <0.001).
Maltese: Fl-istudju CQVJ499A2402, SIMBRINZA + qtar tal-għajnejn travoprost-timolol maleate wrew effikaċja superjuri biex inaqqsu l-IOP mil-linja bażi meta mqabbla ma' Veikolu + qtar talgħajnejn travoprost-timolol maleate wara 6 ġimgħat ta' kura, b'differenza fil-perjodu bejn il-kura filbidla medja aġġustata skont il-mudell mil-linja bażi f'IOP matul il-jum ta' -2.15 mmHg (95% CI, -2.8, -1.5; valur p <0.001).
English: 2, madarosis
Maltese: 2, madarożi
English: EU/1/14/933/001-002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/933/001-002
English: White-to-off-white uniform suspension, pH 6.5 (approximately).
Maltese: Suspensjoni uniformi bajda għal abjad maħmuġ, pH ta' 6.5 (bejn wieħed u ieħor).
English: SIMBRINZA contains brinzolamide, which is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption.
Maltese: SIMBRINZA fih brinzolamide, li huwa inibitur sulphonamide ta 'carbonic anhydrase b'assorbiment sistemiku.
English: This medicine contains 0.15 mg benzalkonium chloride in each 5 ml, which is equivalent to 0.03 mg/ml.
Maltese: Din il-mediċina fiha 0.15 mg ta' benzalkonium chloride f'kull 5 ml, li hu ekwivalenti għal 0.03 mg/ml.
English: Mean IOP reductions from baseline at each time point at each visit were greater with SIMBRINZA (6 to 9 mmHg) than monotherapy with either brinzolamide (5 to 7 mmHg) or brimonidine (4 to 7 mmHg).
Maltese: Tnaqqis medju fl-IOP mil-linja bażi f'kull punt ta 'ħin f'kull vista kien akbar b'SIMBRINZA(6 sa 9 mmHg) minn monoterapija b'brinzolamide (5 sa 7 mmHg) jew brimonidine (4 sa 7 mmHg).
English: Acid/base disturbances
Maltese: Disturbi fl-aċidità/alkalinità
English: Brinzolamide belongs to a group of medicines called carbonic anhydrase inhibitors and brimonidine tartrate belongs to a group of medicines called alpha-2 adrenergic receptor agonists.
Maltese: Brinzolamide jagħmel parti minn grupp ta 'mediċini msejħa inibituri ta 'carbonic anhydrase u brimonidine tartrate jagħmel parti minn grupp ta 'mediċini msejħa agonisti tar-riċetturi alpha-2 adrenerġiċi.
English: Other medicines and SIMBRINZA
Maltese: Mediċini oħra u SIMBRINZA
English: 2, rash maculopapular pruritus generalised
Maltese: 2, raxx makulopapulari
English: System Organ Classification
Maltese: Klassi tas-Sistemi u talOrgani
English: 2, arrhythmia palpitations
Maltese: 3,palpitazzjonijiet