FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs and symptoms of ocular irritation (e.g. burning, stinging, itching, tearing, redness), choroidal detachment following filtration surgery (see section 4.4), decreased corneal sensitivity, diplopia
Maltese: Sinjali u sintomi ta' irritazzjoni fl-għajnejn (eż. ħruq, tingiż, ħakk, dmugħ, ħmura), distakk korojdali wara kirurġija ta' filtrazzjoni (ara sezzjoni 4.4), tnaqqis fis-sensittività tal-korneja, diplopja
English: CARTON FOR SINGLE BOTTLE 2.5 mL + CARTON FOR 3 x 2.5 mL BOTTLES + CARTON FOR 6 x 2.5 mL BOTTLES
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA GĦALLFLIXKUN WIEĦED 2.5 mL + KARTUNA GĦAL 3 x 2.5 mL FLIXKEN + KARTUNA GĦAL 6 x 2.5 mL FLIXKEN
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain, arthralgia Renal and urinary disorders
Maltese: Uġigħ muskoluskeletriku, artralġja
English: Asthma aggravated, rhinitis allergic, epistaxis, respiratory disorder, nasal congestion, nasal dryness
Maltese: Aggravar tal-ażżma, rinite allerġika, epistassi, disturb respiratorju, konġestjoni fl-imnieħer, imnieħer xott
English: Cerebral ischaemia, increases in signs and symptoms of myasthenia gravis
Maltese: Iskemija ċerebrali, żjieda fis-sinjali u sintomi ta' majastenija gravis
English: Timolol may interact with other medicinal products (see section 4.5).
Maltese: Timolol jista' jkollu effett fuq prodotti mediċinali oħra (ara sezzjoni 4.5)
English: Date of first authorisation: 24 April 2006 Date of last renewal: 07 October 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24 ta' April 2006
English: Approximately 20% of a timolol dose is excreted in the urine unchanged and the remainder excreted in urine as metabolites.
Maltese: Madwar 20% tad-doża ta' timolol tiġi eliminata mhux mibdula fl-awrina u l-kumplament tiġi mneħħija fl-awrina bħala metaboliti.
English: DuoTrav preserved with polyquaternium-1 induced minimal ocular surface toxicity, compared to eye drops preserved with benzalkonium chloride, on cultured human corneal cells and following topical ocular administration in rabbits.
Maltese: DuoTrav ippreservat b'Polyquaternium-1 ikkawża tossiċità minima fis-superfiċje tal-għajn fuq ċelluli tal-korneja umana kkulturati u wara għoti topika fl-għajn lill-fniek, meta mqabbel ma' qtar għallgħajnejn ippreservati b'benzalkonium chloride.
English: DuoTrav contains hydrogenated castor oil and propylene glycol which may cause skin reactions and irritation.
Maltese: DuoTrav fih hydrogenated castor oil u propylene glycol li jistgħu jikkawżaw reazzjonijiet u irritazzjoni fil-ġilda.
English: Tiny amounts of sodium hydroxide or hydrochloric acid are added to keep acidity levels (pH levels) normal.
Maltese: Jiġu miżjuda ammonti żgħar ta' sodium hydroxide jew hydrochloric acid biex iżommu l-livelli ta' l-acidita' (livelli tal-pH) normali.
English: Raynaud's phenomenon, cold hands and feet
Maltese: Fenomenu ta' Raynaud, idejn u saqajn kesħin
English: Each mL of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).
Maltese: Kull mL ta' soluzzjoni fih 40 mikrogramma travoprost u 5 mg timolol (bħala timolol maleate).
English: Macular oedema has been reported during treatment with prostaglandin F2 analogues.
Maltese: Edima makulari kienet irrappurtata waqt kura b'analogi ta' prostaglandin F2.
English: DuoTrav contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
Maltese: DuoTrav fih polyoxyethylene hydrogenated castor oil 40 li jista jikkawża reazzjonijiet fil-ġilda.
English: Epidemiological studies have not revealed malformative effects but show a risk for intrauterine 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: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops travoprost/timolol
Maltese: DuoTrav 40 mikrogramma/mL + 5 mg/mL qtar għall-għajnejn travoprost/timolol
English: Reproduction and development studies have demonstrated a potent effect on foetal loss with a high rate observed in rats and mice (180 pg/mL and 30 pg/mL plasma, respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/mL).
Maltese: Studji dwar ir-riproduzzjoni u l-iżvilupp urew effett qawwi fuq it-telf tal-fetu, b'rata għolja osservata filfirien u ġrieden (180 pg/mL u 30 pg/mL fil-plażma, rispettivament) f'espożizzjonijiet ta' 1.2 sa 6 darbiet l-espożizzjoni klinika (sa 25 pg/mL).
English: The use of two local prostaglandins is not recommended.
Maltese: Mhux irrakkomandat l-użu ta' żewġt prostaglandins lokali.
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: The systemic metabolic pathways parallel those of endogenous prostaglandin F2 which are characterised by reduction of the 13-14 double bond, oxidation of the 15-hydroxyl and -oxidative cleavages of the upper side chain.
Maltese: Ir-rotot metaboliċi fil-ġisem jixbhu lil dawk ta' prostaglandin F2α endoġenu li huma kkaratterizzati minn tnaqqis tad-double bond 13-14, ossidazzjoni tal-qsim 15-hydroxy u β-oxidative tal-katina tat-tarf tan-naħa ta' fuq.
English: Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking medicinal products may occur.
Maltese: Minħabba l-komponent beta-adrenerġiku, timolol, jistgħu jseħħu l-istess tipi ta' reazzjonijiet avversi kardjovaskulari, pulmonari u oħrajn kif osservati bi prodotti mediċinali sistemiċi mblokkaturi tar-riċetturi beta-adrenerġiċi.
English: When measurable (0.01 ng/mL, the assay limit of quantitation), concentrations ranged from 0.01 to 0.03 ng/mL.
Maltese: Meta setgħa jiġi mkejjel (≥0.01 ng/mL, il-limitu tal-assay tal-kwantifikazzjoni), il-konċentrazzjonijiet varjaw minn 0.01 sa 0.03 ng/mL.
English: • breathing problems, asthma or chronic obstructive pulmonary disease.
Maltese: • problemi fin-nifs, ażżma jew marda ostruttiva kronika tal-pulmun.
English: Surgical anaesthesia
Maltese: Reazzjonijiet Anafilattiċi
English: Nervous system and general disorders: difficulty sleeping (insomnia), nightmares, memory loss, loss of strength and energy, anxiety (excessive emotional distress).
Maltese: Disturbi fis-sistema nervuża u disturbi ġenerali: diffikultà biex torqod (insomnja), inkubi, telf ta' memeorja, nuqqas ta' saħħa u enerġija, ansjetà (tensjoni emozzjonali eċċessiva).
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 irrappurtat waqt kura b'inibituri ta' CYP2D6 (eż. quinidine, fluoxetine, paroxetine) flimkien ma' timolol.
English: Pharmacotherapeutic group: Ophthalmologicals; Antiglaucoma preparations and miotics, ATC code: S01ED51.
Maltese: Oftalmoloġiċi; Preparazzjonijiet kontra l-glawkoma u mijotiċi, Kodiċi ATC:
English: Severe allergic rhinitis and corneal dystrophies.
Maltese: Rinite allerġika severa u distrofiji tal-korneja.
English: The drop will go in here (picture 2).
Maltese: Il-qatra se tmur hawn (stampa 2).
English: Systemic allergic reactions including angioedema, urticaria, localised and generalised rash, pruritus, anaphylaxis
Maltese: Reazzjonijiet allerġiċi sistemiċi li jinkludu anġjoedima, urtikarja, raxx lokalizzat u ġeneralizzat, ħakk, anafilassi
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: Timolol is metabolised by two pathways.
Maltese: Timolol huwa metaboliżżat minn żewġ rotot.
English: Rare side effects (may affect up to 1 in 1,000 people) Effects in the eye
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000) Effetti fl-għajn
English: Other medicines and DuoTrav
Maltese: Mediċini oħra u DuoTrav
English: • diabetes (as timolol may mask signs and symptoms of low blood sugar).
Maltese: • dijabete (peress li timolol jista' jgħatti sinjali u sintomi ta' zokkar baxx fid-demm).
English: Hypersensitivity to other beta blockers.
Maltese: Sensittività eċċessiva għall-imblokkaturi oħra tar-riċetturi beta.
English: Corneal erosion, meibomianitis, conjunctival haemorrhage, eyelid margin crusting, trichiasis, distichiasis
Maltese: Taħfir tal-korneja, meibomianitis, emorraġija filkonġuntiva, qoxra fix-xifer tal-kappell tal-għajnejn, trikajażi, distikajażi
English: Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second- or third-degree atrioventricular block not controlled with pacemaker.
Maltese: Bradikardja tas-sinus, sindrome ta' sinus marid, inkluż blokk sino-atrijali, sadd atrioventrikolari tattieni jew tat-tielet grad mhux ikkontrolalt b'pacemaker.
English: The mean timolol steady-state Cmax was 1.34 ng/ml and Tmax was approximately 0.69 hours after once-daily administration of DuoTrav.
Maltese: C max fi stat stabbli medja ta' timolol kienet 1.34 ng/ml u T max kien madwar 0.69 siegħa wara l-għoti ta' darba kuljum ta' DuoTrav.
English: 2.5 mL oval polypropylene (PP) or low-density polyethylene (LDPE) bottle and PP or LDPE dispensing plug with PP screw cap, presented in an overwrap.
Maltese: Flixkun ovali ta' 2.5 mL magħmul minn polypropylene (PP) jew polyethylene ta' densità baxxa (LDPE - Low Density Polyethylene) u tapp għall-għoti magħmul minn PP jew LDPE b'għatu bilkamin magħmul minn PP, ippreżentati f'pakkett ta' protezzjoni.
English: Beta blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).
Maltese: Imblokkaturi tar-riċetturi beta jistgħu jaħbu is-sinjali u s-sintomi ta' ipogliċemija (ara sezzjoni 4.4).
English: • if you are allergic to travoprost, prostaglandins, timolol, beta blockers or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal travoprost, prostaglandins, timolol, imblokkaturi tar-riċetturi beta jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Oedema, congestive heart failure, atrioventricular block, cardiac arrest
Maltese: Edima, insuffiċjenza tal-qalb konġestiva, blokk atrijoventrikulari, attakk tal-qalb
English: DuoTrav is a combination of two active substances, travoprost and timolol.
Maltese: DuoTrav huwa taħlita ta' żewġ sustanzi attivi, travoprost u timolol.
English: Not known Dysgeusia
Maltese: Kuntatt mal-ġilda
English: In clinical studies involving 2,170 patients treated with DuoTrav the most frequently reported treatment-related adverse reaction was ocular hyperaemia (12.0%).
Maltese: Fi studji kliniċi fuq 2,170 pazjent ikkurati b'DuoTrav ir-reazzjoni avversa, relatata mal-kura, irrappurtata b'mod l-aktar frekwenti kienet iperimija tal-għajnejn (12.0%).
English: Like other topically applied ophthalmic medicinal products, timolol is absorbed into the systemic circulation.
Maltese: Bħal prodotti mediċinali oħra għall-għajnejn li jiġu applikati b'mod topiku, timolol jiġi assorbit fiċċirkolazzjoni sistemika.
English: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution
Maltese: DuoTrav 40 mikrogramma/mL + 5 mg/mL qtar għall-għajnejn, soluzzjoni
English: Frequency Adverse reactions
Maltese: Sistema tal-klassifika tal-organi Frekwenza Reazzjonijiet avversi
English: Beta blockers may increase the hypoglycaemic effect of antidiabetic medicinal products.
Maltese: Imblokkaturi tar-riċetturi beta jistgħu jżidu l-effett ipogliċemiku ta' prodotti mediċinali kontra ddijabete.
English: What DuoTrav looks like and contents of the pack DuoTrav is a liquid (a clear, colourless solution) supplied in a 2.5 mL plastic bottle with a screw cap. Each bottle is packed in an overwrap.
Maltese: DuoTrav huwa likwidu (soluzzjoni ċara u mingħajr kulur) fornut fi flixkun tal-plastik ta' 2.5 mL b'għatu tal-kamin.
English: The non-inferiority of DuoTrav as compared to latanoprost 50 micrograms/mL + timolol 5 mg/mL in the mean IOP reduction was demonstrated across all time-points at all visits.
Maltese: In-nuqqas ta' nferjorità ta' DuoTrav kif mqabbel ma' latanoprost 50 mikrogramma/mL + timolol 5 mg/mL fil-medja ta' tnaqqis tal-IOP intwera tul il-punti ta' ħin kollha fil-visti kollha.
English: General side effects
Maltese: Effetti sekondarji ġenerali
English: 1 x 2.5 mL 3 x 2.5 mL 6 x 2.5 mL
Maltese: 1 x 2.5 mL
English: Travoprost and timolol are absorbed through the cornea.
Maltese: Travoprost u timolol jiġu asorbiti min ġewwa l-korneja.
English: Inflammation of the eyelid, inflammation in the cornea, detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, outward turning of eyelid with redness, irritation and excessive tears, blurred vision (sign of clouding of the eye lens), swelling of a section of the eye (uvea), eczema of the eyelids, halo vision, decreased eye sensation, pigmentation inside the eye, dilatated pupils, change in eyelash colour, change in the texture of the eyelashes, abnormal field of vision.
Maltese: Infjammazzjoni tal-kappell tal-għajn, infjammazzjoni tal-korneja, distakk tas-saff taħt ir-retina li fih kanali tad-demm wara kirurġija ta' filtrazzjoni li jista' jikkawża disturbi fil-vista, tnaqqis fissensittività tar-retina, tħaffir tal-korneja (ħsara lis-saff ta' barra tal-għajn, viżjoni doppja, tnixxija millgħajn, nefħa madwar l-għajn, ħakk fil-kappell tal-għajn, il-kappell tal-għajn idur il-barra flimkien ma' ħmura, irritazzjoni u dmugħ eċċessiv, vista mċajpra (sinjal li l-lenti tal-għajn ittappnet), nefħa ta' sezzjoni tal-għajn (uvea), ekżema tal-kappell tal-għajn, vista b'awreola, sensazzjoni fl-għajn imnaqqsa, pigmentazzjoni ġewwa l-għajn, ħabba tal-għajn dilatata, bidla fil-kulur tax-xagħar tal-għajnejn, ixxagħar tal-għajnejn jinħass differenti, kamp viżiv mhux normali.
English: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution travoprost/timolol
Maltese: DuoTrav 40 mikrogramma/mL + 5 mg/mL qtar għall-għajnejn, soluzzjoni travoprost/timolol
English: Timolol is a non-selective adrenergic blocking agent that has no intrinsic sympathomimetic, direct myocardial depressant or membrane-stabilising activity.
Maltese: Timolol huwa mblokkatur adrinerġiku mhux selettiv li m'għandux attività simpatomimetika intrinsika, attività ta' depressjoni mijokardijaka diretta jew attività ta' stabilizzazzjoni tal-membrana.
English: Muscle weakness
Maltese: Uġigħ fil-muskoli
English: Uveitis, conjunctival follicles, eye discharge, periorbital oedema, eyelids pruritus, ectropion, cataract, iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, halo vision, hypoaesthesia eye, anterior chamber pigmentation, mydriasis, eyelash hyperpigmentation, eyelash thickening, visual field defect
Maltese: Uveite, follikuli fil-konġuntiva, tnixxija millgħajn, edima madwar l-għajn, ħakk fil-kappell tal-għajn, ectropion, katarretti, iridoċiklite, herpes simplex oftalmika, infjammazzjoni tal-għajnejn, fotopsija, ekżema tal-kappell tal-għajn, vista b'awreola, ipoestesija fl-għajn, pigmentazzjoni tal-kompartiment anterjuri, midrijasi, iperpigmentazzjoni tax-xagħar tal-għajnejn, tħaxxin tax-xagħar tal-għajnejn, difett fil-kamp viżiv
English: Renal and urinary disorders Rare
Maltese: Mhux magħruf Disġewżja Disturbi fil-fwied u fil-marrara Rari
English: Mean IOP reductions were non-inferior, although numerically lower, to those achieved by concomitant therapy with travoprost 40 micrograms/mL dosed once daily in the evening and timolol 5 mg/mL dosed once daily in the morning.
Maltese: Il-medja ta' tnaqqis fl-IOP ma kienux inferjuri, għalkemm numerikament inqas, minn dawk li nkisbu b'terapija fl-istess waqt b'travoprost 40 mikrogramma/mL mogħti darba kuljum filgħaxija u timolol 5 mg/mL mogħti darba kuljum filgħodu.
English: 6 x 2.5 ml - PP bottle
Maltese: 6 x 2.5 ml - Flixkun magħmul minn PP
English: 1 x 2.5 ml - PP bottle
Maltese: 1 x 2.5 ml - Flixkun magħmul minn PP
English: The plasma t1/2 of timolol is 4 hours after ocular administration of DuoTrav.
Maltese: It-t1/2 fil-plażma ta' timolol huwa 4 sigħat wara l-għoti fl-għajn ta' DuoTrav.
English: Travoprost, a prostaglandin F2α analogue, is a full agonist which is highly selective and has a high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways.
Maltese: Travoprost, analogu ta' prostaglandin F2α, huwa agonist komplut li huwa selettiv ħafna u għandu affinita għolja għar-riċettur FP ta' prostaglandin, u jnaqqas il-pressjoni fl-għajn billi jżid il-ħruġ ta' laqueous humour min ġewwa ix-xibka trabekulari u r-rotot uveosklerali.
English: 3 x 2.5 ml - PP bottle
Maltese: 3 x 2.5 ml - Flixkun magħmul minn PP
English: Reactive airway disease including bronchial asthma, or a history of bronchial asthma, severe chronic obstructive pulmonary disease.
Maltese: Marda reattiva tal-passaġġi tal-arja inkluż ażżma tal-bronki, jew passat ta' ażżma tal-bronki, marda kronika severa ta' sadd pulmonari.
English: One route yields an ethanolamine side chain on the thiadiazole ring and the other gives an ethanolic side chain on the morpholine nitrogen and a second similar side chain with a carbonyl group adjacent to the nitrogen.
Maltese: Rotta minnħom tipproduċi katina tat-tarf ta' ethanolamine fuq iċ-ċirku thiadiazole u l-oħra tagħti katina tat-tarf etanolika fuq morpholine nitrogen u katina tat-tarf oħra simili bi grupp carbonyl viċin nitrogen.
English: Patients with hepatic or renal impairment are unlikely to require dose adjustment with DuoTrav (see section 5.2).
Maltese: Pazjenti b'indeboliment tal-fwied jew tal-kliewi mhux probabbli li jkollhom bżonn aġġustament fiddoża b'DuoTrav (ara sezzjoni 5.2).
English: Uncommon Dizziness, headache Not known Cerebrovascular accident, syncope, paraesthesia
Maltese: Sturdament, uġigħ ta' ras Mhux magħruf Inċident ċerebrovaskulari, sinkope, parasteżija
English: Not known (frequency cannot be estimated from the available data) Effects in the eye
Maltese: Mhux magħruf (frekwenza ma tistax tiġi stmata mid-dejta disponibbli) Effetti fl-għajn
English: Marketing Authorisation Holder Vista Building
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Novartis Europharm Limited Vista Building
English: Additional adverse reactions that have been seen with one of the active substances and may potentially occur with DuoTrav:
Maltese: Reazzjonijiet avversi oħra li kienu osservati b'wieħed mis-sustanzi attivi u li potenzjalment jistgħu jseħħu b'DuoTrav:
English: There are no data on the effects of DuoTrav on human fertility.
Maltese: M'hemmx dejta dwar l-effetti ta' DuoTrav fuq il-fertilità fil-bniedem.
English: Nervousness, irregular heart rate, loss of hair, voice disorders, difficulty breathing, cough, throat irritation, hives, abnormal liver blood tests, skin discolouration, thirst, tiredness, discomfort inside of nose, coloured urine, pain in hands and feet.
Maltese: Nervi, rata irregolari ta' taħbit tal-qalb, telf ta' xagħar, disturbi fil-vuċi, diffikultà biex tieħu n-nifs, sogħla, irritazzjoni fil-griżmejn, ħorriqija, testijiet tad-demm tal-fwied mhux normali, bidla fil-kulur tal-ġilda, għatx, għeja, skomdu fil-parti ta' ġewwa tal-imnieħer, awrina kkulurita, uġigħ fl-idejn u ssaqajn.
English: Muscular: increases in signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations like pins and needles, muscle weakness/tiredness, muscle pain not caused by exercise, joint pain.
Maltese: Muskolari: żjieda fis-sinjali u sintomi ta' majastenija gravis (disturb fil-muskoli), sensazzjonijiet mhux tas-soltu ta' tingiż, debbulizza/għeja fil-muskoli, uġigħ fil-muskoli mhux ikkawżat minn eżerċizzju, uġigħ fil-ġogi.
English: In a twelve-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 DuoTrav dosed once daily in the morning was 8 to 10 mmHg.
Maltese: Fi studju kliniku kkontrollat ta' tnax-il xahar f'pazjenti bi glawkoma open angle jew pressjoni għolja ta' l-għajnejn u linja bażi medja ta' IOP ta' 25 sa 27 mmHg, il-medja tal-effett ta' tnaqqis fl-IOP ta' DuoTrav mogħti darba kuljum filgħodu kien ta' 8 sa 10 mmHg.
English: Excipients
Maltese: Puurs
English: Seasonal allergy
Maltese: Anestesija kirurġika
English: A topical overdose with DuoTrav is not likely to occur or to be associated with toxicity.
Maltese: Doża eċċessiva topika b'DuoTrav mhux probabbli li sseħħ jew li tkun assoċjata ma' tossiċità.
English: Punctate keratitis, eye pain, visual disturbance, vision blurred, dry eye, eye pruritus, ocular discomfort, eye irritation
Maltese: Keratite bil-ponot, uġigħ fl-għajn, disturbi fil-vista, vista mċajpra, għajn tinħass xotta, ħakk fl-għajn, skomdu fl-għajn, irritazzjoni fl-għajn
English: A statistically superior reduction in morning mean IOP (08:00, 24 hours after the last dose of DuoTrav) was observed compared to travoprost at all visits throughout the study.
Maltese: Fil-visti kollha tul l-istudju kien osservat tnaqqis statistikament superjuri fl-IOP medja ta' filgħodu (08:00, 24 siegħa wara l-aħħar doża ta' DuoTrav) meta mqabbel ma' travoprost.
English: DuoTrav must not be used in women of child-bearing age/potential unless adequate contraceptive measures are in place (see section 5.3).
Maltese: DuoTrav m'għandux jintuża f'nisa ta' età/potenzjal li jista' jkollhom it-tfal sakemm ma jintużawx meżżi sikuri ta' kontraċezzjoni (ara sezzjoni 5.3).
English: For information on how to reduce systemic absorption, see section 4.2.
Maltese: Għal tagħrif dwar kif tnaqqas l-assorbiment sistemiku, ara sezzjoni 4.2.
English: Vertigo, tinnitus
Maltese: Uġigħ fl-estremitajiet
English: DuoTrav is indicated in adults for the decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta blockers or prostaglandin analogues (see section 5.1).
Maltese: DuoTrav huwa indikat fl-adulti għat-tnaqqis tal-pressjoni fl-għajnejn (IOP) f'pazjenti bi glawkoma tattip open-angle jew pressjoni għolja ta' l-għajnejn li ma rrispondewx b'mod suffiċjenti b'kura topika ta' imblokkaturi tar-riċetturi beta jew analogi ta' prostaglandin (ara sezzjoni 5.1).
English: Hypersensitivity to the active substances, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Urticaria, skin discolouration, alopecia Not known Rash
Maltese: Arritmija, rata ta' taħbit tal-qalb irregolari
English: Uncommon Keratitis, iritis, conjunctivitis, anterior chamber inflammation, blepharitis, photophobia, visual acuity reduced, asthenopia, eye swelling, lacrimation increased, erythema of eyelid, growth of eyelashes, eye allergy, conjunctival oedema, eyelid oedema
Maltese: Keratite, infjammazzjoni tal-ħabba tal-għajn, konġuntivite, infjammazzjoni fil-kompartiment anterjuri, blefarite, fotofobija, akutezza tal-vista mnaqqsa, astenopija, nefħa fl-għajn, żjieda fiddmugħ, eritema tal-kappell tal-għajn, tkabbir taxxagħar tal-għajnejn, allerġija fl-għajn, edima filkonġuntiva, edima fil-kappell ta' l-għajn