FrancophonIA/ELRC3.0 huggingface dataset:
English: Not known: corneal perforation, impaired healing (cornea), corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision
Maltese: Mhux magħruf: perforazzjoni tal-kornea, fejqan indebolit (kornea), opaċità tal-kornea, ċikatriċi filkornea, tnaqqis fl-akutezza viżiva, nefħa fl-għajn, keratite ulċerattiva, kornea tirqaq, vista mċajpra
English: A greater percentage of patients treated with vehicle experienced a decrease in BCVA of more than 5 letters from day 7 to day 90 (or early exit) (11.5%) compared with patients treated with nepafenac (5.6%).
Maltese: Perċentwali ogħla ta' pazjenti kkurati bl-eċċipjent esperjenzaw tnaqqis fil-BCVA ta' aktar minn 5 ittri minn jum 7 sa jum 90 (jew ħruġ bikri) (11.5%) meta mqabbel ma' pazjenti kkurati b'Nepafenac (5.6%).
English: C-nepafenac to healthy volunteers, urinary excretion was found to be the major route of radioactive excretions, accounting for approximately 85% while faecal excretion represented approximately 6% of the dose.
Maltese: C-nepafenac lill-voluntiera f'saħħithom, tneħħija fl-awrina nstabet li kienet ir-rotta maġġuri tat-tneħħijiet radjuattivi, li tgħodd għal madwar 85% filwaqt li tneħħijja fl-ippurgar tirrappreżenta madwar 6% tad-doża.
English: 1 ml of suspension contains 3 mg nepafenac.
Maltese: Ml ta' suspensjoni fih 3 mg nepafenac.
English: Rare: iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia
Maltese: Rari: irite, effużjoni korojdali, depożiti fil-kornea, uġigħ fl-għajn, skonfort fl-għajn, għajn xotta, blefarite, irritazzjoni fl-għajn, ħakk fl-għajn, tnixxija mill-għajn, konġuntivite allerġika, żieda fid-dmugħ, iperimija konġuntivali
English: What NEVANAC looks like and the contents of the pack NEVANAC is a liquid (light yellow to light orange suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap.
Maltese: NEVANAC huwa likwidu (suspenjoni safra ċara sa oranġjo ċara) disponibbli f'pakkett li fiħ flixkun wieħed tal-plastik ta' 5 ml b'għatu bil-kamin.
English: Light yellow to light orange uniform suspension, pH 7.4 (approximately).
Maltese: Suspensjoni uniformi, safra ċara sa oranġjo ċara, pH 7.4
English: The most frequently reported adverse reaction was punctate keratitis which occurred in 3% of patients, resulting in a frequency category of common.
Maltese: L-aktar reazzjoni avversa rrappurtata b'mod frekwenti kienet keratite ittikkjata li seħħet fi 3% talpazjenti, li rriżulta f'kategorija ta' frekwenza komuni.
English: In the two clinical studies involving 594 patients, diabetic patients were exposed to NEVANAC eye drops, suspension treatment for 90 days for the prevention of macular oedema post cataract surgery.
Maltese: Fiż-żewġ studji kliniċi li kienu jinvolvu 594 pazjent, pazjenti dijabetiċi kienu esposti għal trattament b'NEVANAC qtar għall-għajnejn, suspensjoni għal 90 jum għall-prevenzjoni ta' edima makulari wara kirurġija tal-katarretti.
English: - The other ingredients are benzalkonium chloride (see section 2), carbomer, disodium edetate, mannitol, purified water, sodium-chloride and tyloxapol.
Maltese: • Is-sustanzi l-oħra huma benzalkonium chloride (ara sezzjoni 2), carbomer, disodium edetate, mannitol, ilma ppurifikat, sodium-chloride u tyloxapol.
English: Novartis Pharma N.V.
Maltese: Novartis Pharma Services Inc.
English: However, no effects on suckling children are anticipated.
Maltese: Madankollu, mhux mistennija effetti fittarbija li qed terda'.
English: The drop will go in here (picture 1).
Maltese: Il-qatra tmur hemm (stampa 1).
English: In 1 double-masked, randomised vehicle-controlled study, conducted in diabetic retinopathy patients, a significantly greater percentage of patients in the vehicle group developed macular oedema (16.7%) compared to patients treated with NEVANAC (3.2%).
Maltese: Fi studju wieħed double-masked, randomised u kkontrollat b'eċċipjent, li twettaq fuq pazjenti dijabetiċi b'retinopatija, perċentwali sinifikatament ogħla ta' pazjenti fil-grupp tal-eċċipjent żviluppaw edima makulari (16.7%) meta mqabbla ma' pazjenti kkurati b'NEVANAC (3.2%).
English: The preservative in NEVANAC, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Maltese: Il-preservattiv f'NEVANAC, benzalkonium chloride, jista' jiġi assorbit mil-lentijiet tal-kuntatt rotob u jista' jbiddel l-kulur tal-lentijiet tal-kuntatt.
English: NSAIDs do not have any anti-microbial properties.
Maltese: NSAIDs m'għandhomx kwalitajiet li jaħdmu kontra l-mikrobi.
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Novartis Pharma N.V.
English: Amfenac was the major metabolite in plasma, representing approximately 13% of total plasma radioactivity.
Maltese: Amfenac kien il-metabolita maġġuri filplażma, li jirrappreżenta madwar 13% tar-radjuattività totali fil-plażma.
English: Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients
Maltese: Prevenzjoni u kura ta' uġigħ u infjammazzjoni wara operazzjoni marbuta ma' intervent kirurġiku talkatarretti
English: In the two studies, NEVANAC cleared inflammation at day 14 post operation in 65% and 68% of patients compared to 25% and 35% of patients on vehicle.
Maltese: Fiż-żewġ studji, NEVANAC fejjaq l-infjammazzjoni f'jum 14 wara l-kirurġija f'65% u 68% tal-pazjenti meta mqabbla ma' 25% u 35% tal-pazjenti fuq l-istess suspensjoni mingħajr mediċina.
English: NEVANAC 3 mg/ml eye drops, suspension is indicated in adults for:
Maltese: NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni hu indikat f'adulti għal:
English: In both double-masked, randomised vehicle-controlled studies, conducted in diabetic retinopathy patients, a significantly greater percentage of patients in the vehicle group developed macular oedema (17.3% and 14.3%) compared to patients treated with NEVANAC 3 mg/ml (2.3% and 5.9%).
Maltese: Fiż-żewġ studji double-masked, randomised u kkontrollat b'eċċipjent, li twettqu f'pazjenti dijabetiċi b'retinopatija, perċentwali sinifikatament ogħla ta' pazjenti fil-grupp tal-eċċipjent żviluppaw edima makulari (17.3% u 14.
English: From post-marketing experience with NEVANAC 1 mg/ml eye drops, suspension, cases reporting corneal epithelium defect/disorder have been identified.
Maltese: Minn esperjenza ta' wara t-tqegħid fis-suq b'NEVANAC 1 mg/ml qtar għall-għajnejn, suspensjoni, kienu identifikati każijiet fejn ġew irrappurtati difetti/disturbi fl-epitelju korneali.
English: Subsequently, amfenac undergoes extensive metabolism to more polar metabolites involving hydroxylation of the aromatic ring leading to glucuronide conjugate formation.
Maltese: Wara dan, amfenac jgħaddi minn metaboliżmu estensiv għall-metaboliti aktar polari li jinvolvi idroksilazzjoni taċ-ċirku aromatiku li jwassal għall-formazzjoni ta' konjugat ta' glucuronide.
English: - The other ingredients are boric acid, propylene glycol, carbomer, sodium chloride, guar, carmellose sodium, disodium edetate, benzalkonium chloride (see section 2) and purified water.
Maltese: • Is-sustanzi l-oħra huma boric acid, propylene glycol, carbomer, sodium chloride, guar, carmellose sodium, disodium edetate, benzalkonium chloride (ara sezzjoni 2) u ilma ppurifikat.
English: Rare: dizziness, headache
Maltese: Rari: sturdament, uġigħ ta' ras
English: The European Medicines Agency has waived the obligation to submit the results of studies with NEVANAC in all subsets of the paediatric population in prevention and treatment of post operative pain and inflammation associated with cataract surgery and prevention of post surgical macular oedema (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat l-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'NEVANAC f'kull sett tal-popolazzjoni fil-prevenzjoni u l-kura ta' uġigħ u infjammazzjoni wara operazzjoni assoċjati ma' kirurġija tal-katarretti u l-prevenzjoni ta' edima makulari wara kirurġija (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Therefore, interactions involving CYP-mediated metabolism of concomitantly administered medicinal products are unlikely.
Maltese: Għalhekk, interazzjonijiet li jinvolvu metaboliżmu medjat minn CYP ta' prodotti mediċinali mogħtija fl-istess ħin mhux probabbli.
English: The mean steady-state plasma Cmax for nepafenac and for amfenac were 0.310 ± 0.104 ng/ml and 0.422 ± 0.121 ng/ml, respectively, following ocular administration.
Maltese: Cmax medja fil-plażma fi stat fiss għal nepafenac u għal amfenac kienet 0.310 ± 0.104 ng/ml u 0.
English: In the two clinical studies involving 209 patients, diabetic patients were exposed to NEVANAC treatment for 60 days or greater for the prevention of macular oedema post cataract surgery.
Maltese: Fiż-żewġ studji kliniċi li kienu jinvolvu 209 pazjent, pazjenti dijabetiċi kienu esposti għall-kura b'NEVANAC għal 60 jum jew aktar għall-prevenzjoni ta' edima makulari wara kirurġija tal-katarretti.
English: NEVANAC 1 mg/ml eye drops, suspension nepafenac
Maltese: NEVANAC 1 mg/ml qtar għall-għajnejn, suspensjoni nepafenac
English: In clinical studies involving over 1900 patients receiving NEVANAC 3 mg/ml eye drops, suspension, the most frequently reported adverse reactions were punctate keratitis, keratitis, foreign body sensation in eyes and eye pain which occurred in between 0.4% and 0.1% of patients.
Maltese: Fi studji kliniċi li kienu jinvolvu aktar minn 1,900 pazjent li kienu qed jirċievu NEVANAC 3 mg/ml qtar għall-għajnejn l-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti kienu keratite ittikkjata, keratite, sensazzjoni ta' oġġett barrani fl-għajn, u uġigħ fl-għajn li seħħew f'bejn 0.4% u 0.1% talpazjenti.
English: NEVANAC 3 mg/ml eye drops, suspension nepafenac
Maltese: NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni nepafenac
English: What NEVANAC looks like and contents of the pack NEVANAC eye drops, suspension (eye drops) is a liquid (light yellow to dark orange suspension) supplied in a plastic bottle with a screw cap. Each bottle may be placed in a pouch.
Maltese: NEVANAC qtar għall-għajnejn, suspensjoni (qtar għall-għajnejn) huwa likwidu (suspenjoni safra ċara sa oranġjo skur) disponibbli fi flixkun tal-plastik b'għatu bil-kamin.
English: NEVANAC 3 mg/ml eye drops nepafenac
Maltese: NEVANAC 3 mg/ml qtar għall-għajnejn nepafenac
English: NEVANAC 1 mg/ml eye drops nepafenac
Maltese: NEVANAC 1 mg/ml qtar għall-għajnejn nepafenac
English: When nepafenac is prescribed to a diabetic patient post cataract surgery to prevent macular oedema, the existence of any additional risk factor should lead to reassessment of the foreseen benefit/risk and to intensified patient monitoring.
Maltese: Meta nepafenac jiġi preskritt lill-pazjent dijabetiku wara operazzjoni talkatarretti sabiex tiġi evitata edima makulari, l-eżistenza ta' kwalunkwe fattur addizzjonali ta' riskju għandu jwassal għall-evalwazzjoni mill-ġdid tal-benefiċċju/riskju previst u għal monitoraġġ intensifikat tal-pazjent.
English: In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation (see section 4.8).
Maltese: F'ċertu pazjenti suxxettibli, l-użu kontinwu ta' NSAIDs topiċi jista' jwassal għal kollass tal-epitelju, korneja li tirqaq, taħfir tal-kornea, ulċerazzjoni tal-korneja jew perforazzjoni tal-korneja (ara sezzjoni 4.8).
English: There are very limited data on the concomitant use of prostaglandin analogues and NEVANAC.
Maltese: Hemm dejta limitata ħafna dwar l-użu ta' analogi ta' prostaglandin flimkien ma' NEVANAC.
English: NEVANAC 3 mg/ml eye drops, suspension
Maltese: NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni
English: The following side effects have also been observed with NEVANAC 1 mg/ml eye drops, suspension or NEVANAC 3 mg/ml eye drops, suspension, or both.
Maltese: L-effetti sekondarji li ġejjin ukoll kienu osservati b'NEVANAC 1 mg/ml qtar għall-għajnejn, suspensjoni jew NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni, jew it-tnejn.
English: • General side effects: dizziness, headache, allergic symptoms (eyelid allergic swelling), nausea, skin inflammation, redness and itching.
Maltese: • Effetti sekondarji ġenerali: sturdament, uġigħ ta' ras, sintomi allerġiċi (nefħa kkawżata minn allerġija ta' tebqet l-għajn), dardir, infjammazzjoni, ħmura u ħakk fil-ġilda.
English: Clinical trial experience for the long-term use of NEVANAC for the prevention of macular oedema post cataract surgery in diabetic patients is limited.
Maltese: Esperjenza minn provi kliniċi fuq perjodu ta' użu fit-tul b'NEVANAC għall-prevenzjoni ta' edima makulari wara kirurġija tal-katarretti f'pazjenti dijabetiċi hija limitata.
English: Radiochromatographic analyses before and after β-glucuronidase hydrolysis indicated that all metabolites were in the form of glucuronide conjugates, with the exception of amfenac.
Maltese: Analiżi radjukromatografika qabel u wara l-idrolisi ta' β-glucuronidase tindika li l-metaboliti kollha kienu fil-forma ta' konjugat ta' glucuronide, bl-eċċezzjoni ta' amfenac.
English: Concomitant use of NEVANAC with medications that prolong bleeding time may increase the risk of haemorrhage (see section 4.4).
Maltese: Lużu ta' NEVANAC flimkien ma' mediċini li jtawwlu l-ħin ta' fsada jista' jżid ir-riskju ta' emorraġija (ara sezzjoni 4.4).
English: NEVANAC is to be used by adults: - to prevent and relieve eye pain and inflammation following cataract surgery on the eye - to reduce the risk of macular oedema (swelling in the back of the eye) following cataract surgery on the eye in diabetic patients.
Maltese: NEVANAC għandu jintuża minn adulti: - biex jipprevjeni u jtaffi uġigħ u infjammazzjoni fl-għajn wara kirurġija tal-kataretti fl-għajn - biex inaqqas ir-riskju ta' edima makulari (nefħa fuq in-naħa ta' wara tal-għajn) wara kirurġija tal-katarretti fl-għajn f'pazjenti dijabetiċi.
English: Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening.
Maltese: Esperjenza ta' wara t-tqegħid fis-suq b'NSAIDs topiċi tissuġġerixxi li pazjenti b'kirurġiji ikkomplikati tal-għajnejn, denervazzjoni tal-kornea, difetti fl-epitelju tal-kornea, dijabete mellitus, mard fissuperfiċje tal-għajn (eż., sindrome tal-għajn xotta), artrite rewmatojde jew kirurġiji ripetuti fl-għajn f'perijodu qasir ta' żmien, jistgħu jkunu f'riskju akbar ta' reazzjonijiet avversi tal-kornea li jistgħu jsiru ta' periklu għall-vista.
English: From post-marketing experience with NEVANAC, cases reporting corneal epithelium defect/disorder have been identified.
Maltese: Minn esperjenza ta' wara t-tqegħid fis-suq b'NEVANAC, kienu identifikati każijiet fejn ġew irrappurtati difetti/disturbi fl-epitelju korneali.
English: Once-daily dosing with NEVANAC 3 mg/ml eye drops, suspension provides the same total daily dose of nepafenac as three-times-daily dosing with NEVANAC 1 mg/ml eye drops, suspension.
Maltese: Dożaġġ ta' darba kuljum ta' NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni jipprovdi l-istess doża totali ta' kuljum ta' nepafenac daqs dożaġġ ta' tliet darbiet kuljum ta' NEVANAC 1 mg/ml qtar għall-għajnejn, suspensjoni.
English: NEVANAC 1 mg/ml eye drops, suspension
Maltese: NEVANAC 1 mg/ml qtar għall-għajnejn, suspensjoni
English: For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician.
Maltese: Għat-tnaqqis fir-riskju ta' edima makulari wara kirurġija assoċjat ma' kirurġija tal-katarretti f'pazjenti dijabetiċi, id-doża hija qatra waħda ta' NEVANAC fil-borża konġuntivali tal-għajn(ejn) affettwata 3 darbiet kuljum, li tinbeda minn jum qabel l-intervent kirurġiku għall-katarretti, titkompla fil-jum talkirurġija u sa 60 jum wara l-perijodu tal-operazzjoni skont l-istruzzjonijiet tat-tabib.
English: Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening.
Maltese: Esperjenza wara t-tqegħid fis-suq b'NSAIDs topiċi tissuġġerixxi li pazjenti b'kirurġiji komplikati ta' lgħajn, denervazzjoni tal-korneja, difetti fl-epitelju tal-korneja, dijabete mellitus, mard fis-superfiċje ta' l-għajn (eż. sindrome ta' l-għajn xotta), artrite rewmatojda jew kirurġiji ripetuti fl-għajn f'perjodu qasir ta' żmien, jistgħu jkunu f'riskju ikbar ta' reazzjonijiet avversi tal-korneja li jistgħu jsiru ta' periklu għall-vista.
English: Two studies in diabetic patients were conducted to assess the efficacy and safety of NEVANAC 3 mg/ml eye drops, suspension dosed once a day for the prevention of postoperative macular oedema associated with cataract surgery.
Maltese: Twettqu żewġ studji f'pazjenti dijabetiċi biex jiġu stmati l-effikaċja u s-sigurtà ta' NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni ddożat darba kuljum għall-prevenzjoni ta' edima makulari wara operazzjoni marbuta ma' intervent kirurġiku għall-katarretti.
English: NEVANAC contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses.
Maltese: NEVANAC fih benzalkonium chloride li jista' jikkawża irritazzjoni fl-għajnejn u huwa magħruf li jbiddel il-kulur ta' lentijiet tal-kuntatt rotob.
English: For storage conditions after first opening of the medicinal product, see section 6.3
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: The following side effects have been observed with NEVANAC 3 mg/ml eye drops, suspension or NEVANAC 1 mg/ml eye drops, suspension or both.
Maltese: L-effetti sekondarji li ġejjin kienu osservati b'NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni jew Nevanac 1 mg/ml qtar għall-għajnejn, suspensjoni jew it-tnejn.
English: Tiny amounts of sodium hydroxide and/or hydrochloric acid are added to keep acidity levels (pH levels) normal.
Maltese: Ammonti żgħar ta' sodium hydroxide u/jew hydrochloric acid huma miżjuda biex iżommu l-livell ta' l-aċidità (livelli tal-pH) normali.
English: • Effects in the eye: iris inflammation, eye pain, eye discomfort, dry eye, eyelid swelling, eye irritation, itchy eye, eye discharge, allergic conjunctivitis (eye allergy), increased tear production, deposits on the eye surface, fluid or swelling at the back of the eye, eye redness.
Maltese: • Effetti fl-għajn: infjammazzjoni tal-ħabba tal-għajn, uġigħ fl-għajn, skonfort fl-għajn, għajn xotta, nefħa tal-kappell tal-għajn, irritazzjoni fl-għajn, ħakk fl-għajn, tnixxija mill-għajn, konġuntivite allerġika (allerġija fl-għajnejn), żieda fid-dmugħ, depożiti fuq is-superfiċje talgħajn, fluwidu jew nefħa fin-naħa ta' wara tal-għajn, ħmura fl-għajn.
English: The other most frequently reported adverse reactions were keratitis and foreign body sensation in eyes which occurred in 0.5% and 0.3% of patients, respectively both adverse reactions with a frequency category of uncommon.
Maltese: Ir-reazzjonijiet avversi l oħra rrappurtati bl-aktar mod frekwenti kienu keratite u sensazzjoni ta' oġġett barrani fl-għajn li seħħew f'0.5% u 0.3% tal-pazjenti, rispettivament.
English: The safety and efficacy of NEVANAC in children and adolescents have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' NEVANAC fit-tfal u l-adolexxenti ma ġewx determinati.
English: In addition, in one of the two clinical trials, NEVANAC 3 mg/ml eye drops, suspension dosed once a day was non-inferior to NEVANAC 1 mg/ml eye drops, suspension dosed three times a day for the prevention and treatment of postoperative pain and inflammation following cataract surgery.
Maltese: Barra minn hekk, f'wieħed miż-żewġ provi kliniċi, NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni ddożat darba kuljum ma kienx inferjuri għal NEVANAC 1 mg/ml qtar għall-għajnejn, suspensjoni ddożat tliet darbiet kuljum għall-prevenzjoni u l-kura ta' uġigħ u infjammazzjoni wara kirurġija tal-katarretti.
English: Interactions mediated by protein binding are also unlikely.
Maltese: Interazzjonijiet medjati minn twaħħil mal-proteini wkoll x'aktarx li ma jseħħux.
English: Some patients received NEVANAC 3 mg/ml eye drops, suspension for up to 21 days post operation.
Maltese: Xi pazjenti rċevew NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni għal sa 21 ġurnata wara lkirurġija.
English: In these studies in which patients were dosed daily beginning one day prior to cataract surgery, continued on the day of surgery and for the first 14 days of the postoperative period, NEVANAC 3 mg/ml eye drops, suspension demonstrated superior clinical efficacy compared to its vehicle in treating postoperative pain and inflammation.
Maltese: F'dawn l-istudji fejn il-pazjenti kienu ddożati kuljum minn ġurnata qabel il-kirurġija tal-katarretti, komplew fil-ġurnata tal-kirurġija u għall-ewwel 14-il ġurnata tal-perjodu ta' wara l-kirurġija, NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni wera effikaċja klinika superjuri meta mqabbel mal-istess suspensjoni mingħajr mediċina fil-kura ta' uġigħ u infjammazzjoni wara operazzjoni.
English: Adverse reactions
Maltese: MANIFATTUR RESPONSABBLI
English: Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration.
Maltese: Nepafenac huwa eliminat primarjament permezz ta' bijotrasformazzjoni u l-esponiment sistemiku huwa baxx ħafna wara għoti topiku fl-għajnejn.
English: For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) once daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician.
Maltese: Għat-tnaqqis fir-riskju ta' edima makulari wara kirurġija assoċjat ma' kirurġija tal-katarretti f'pazjenti dijabetiċi, id-doża hija qatra waħda ta' NEVANAC fil-borża konġuntivali tal-għajn(ejn) affettwata darba kuljum, li tinbeda minn jum qabel l-intervent kirurġiku għall-katarretti, titkompla fil-jum talkirurġija u sa 60 jum wara l-perijodu tal-operazzjoni skont l-istruzzjonijiet tat-tabib.
English: Prevention and treatment of postoperative pain and inflammation associated with cataract surgery Three pivotal studies were conducted to assess the efficacy and safety of NEVANAC dosed 3 times daily as compared to vehicle and/or ketorolac trometamol in the prevention and treatment of postoperative pain and inflammation in patients undergoing cataract surgery.
Maltese: Twettqu tliet studji pivitali biex jiġu stmati l-effikaċja u s-sigurtà ta' NEVANAC mogħti 3 darbiet kuljum kif imqabbel mal-eċċipjent u/jew ketorolac trometamol fil-prevenzjoni u l-kura ta' uġigħ u infjammazzjoni wara operazzjoni f'pazjenti li għamlu kirurġija tal-katarretti.
English: The most frequently reported adverse reaction was punctate keratitis which occurred in 1% of patients, resulting in a frequency category of common.
Maltese: L-aktar reazzjoni avversa rrappurtata b'mod frekwenti kienet keratite ittikkjata li seħħet f'1% tal-pazjenti, b'riżultat ta' kategorija ta' frekwenza ta' komuni.
English: Studies in rabbits demonstrated that the topically administered nepafenac is distributed locally from the front of the eye to the posterior segments of the eye (retina and choroid).
Maltese: Studji fil-fniek urew li nepafenac mogħti b'mod topiku jiġi distribwit lokalment mill-parti ta' quddiem tal-għajn għall-partijiet posterjuri tal-għajn (retina u korojd).