FrancophonIA/ELRC3.0 huggingface dataset:
English: No evidence of carcinogenicity was observed in a 2-year bioassay in rats at oral doses of fingolimod up to the maximally tolerated dose of 2.5 mg/kg, representing an approximate 50-fold margin based on human systemic exposure (AUC) at the 0.5 mg dose.
Maltese: Ma dehrx li kien hemm evidenza ta' karċinoġeniċità matul bijoanaliżi ta' sentejn fil-firien mogħtija dożi mill-ħalq ta' fingolimod sal-ogħla doża ttollerata ta' 2.5 mg/kg, li tirrappreżenta marġni ta' madwar 50 darba msejsa fuq l-espożizzjoni sistemika (AUC) fil-bniedem b'doża ta' 0.5 mg.
English: If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus).
Maltese: Jekk qatt ma kellek il-ġidri r-riħ, it-tabib tiegħek se jiċċekkja l-immunità tiegħek kontra l-virus li jikkawżaha (il-virus tal-variċella zoster).
English: SINGLE-UNIT-DOSE BLISTERS
Maltese: Il-funzjoni tal-fwied
English: Although most patients did not require medical intervention, one patient on Gilenya 0.5 mg received isoprenaline for asymptomatic second-degree Mobitz I atrioventricular block.
Maltese: Minkejja li ħafna mill-pazjenti ma kellhomx bżonn ta' intervent mediku, pazjent minnhom mogħti 0.5 mg Gilenya ngħata isoprenalina minħabba imblokk atrijoventrikualri Mobitz I asintomatiku tattieni grad.
English: o Vigilance for basal cell carcinoma and other cutaneous neoplasms including malignant melanoma, squamous cell carcinoma, Kaposi's sarcoma and Merkel cell carcinoma is recommended, with skin examination prior to treatment initiation and then every 6 to 12 months taking into consideration clinical judgement.
Maltese: o Huwa rrakkomandat li wieħed għandu joqgħod attent għal karċinoma taċ-ċellula bażali u neoplażmi oħrajn fil-ġilda, inkluż melanoma malinna, karċinoma taċ-ċellula skwamuża, is-sarkoma ta' Kaposi u l-karċinoma taċ-ċellula Merkel, u li ssir evalwazzjoni medika talġilda qabel it-tnedija tat-trattament u mbagħad kull 6 sa 12-il xahar filwaqt li jitqies ilġudizzju kliniku.
English: After 34 days, the recovery of the administered dose is 89%.
Maltese: Wara 34 jum, lirkupru tad-doża mogħtija huwa ta' 89%.
English: The pregnancy-specific patient reminder card shall contain the following key messages:
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni:
English: Not known (frequency cannot be estimated from the available data): - Allergic reactions, including symptoms of rash or itchy hives, swelling of lips, tongue or face, which are more likely to occur on the day you start Gilenya treatment - Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Maltese: - Reazzjonijiet allerġiċi, inkluż sintomi ta' raxx jew ħorriqija bil-ħakk, nefħa fix-xofftejn, fl-ilsien jew fil-wiċċ, li aktar hemm ċans li jiġru dakinhar li jinbeda t-trattament b'Gilenya - Riskju ta' infezzjoni rari fil-moħħ imsejħa lewkoenċefalopatija multifokali (PML).
English: Skin cancers have been reported in MS patients treated with Gilenya.
Maltese: Kienu rrappurtati kanċers tal-ġilda minn pazjenti b'MS ittrattati b'Gilenya.
English: Therefore, blood pressure should be regularly monitored during treatment with Gilenya.
Maltese: Għaldaqstant, il-pressjoni tad-demm għandha tiġi mmonitorjata regolarment b'Gilenya.
English: You must not use Gilenya together with such medicines as this could intensify the effect on the immune system (see also “Do not take Gilenya”).
Maltese: Tiħux Gilenya - jekk għandek sistema immuni li ddum ma tirreaġixxi (minħabba sindromu ta'
English: Until 6 hours after first dose o Monitor the patient for 6 hours after the first dose of GILENYA has been administered for signs and symptoms of bradycardia, including hourly pulse and blood pressure checks.
Maltese: Sa 6 sigħat wara l-ewwel doża o Immonitorja l-pazjent għal 6 sigħat wara li ngħatat l-ewwel doża ta' GILENYA għal sinjali u sintomi ta' bradikardija, inkluż evalwazzjoni kull siegħa tal-polz u l-pressjoni tad-demm.
English: Patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine, should have liver enzymes checked and Gilenya should be discontinued if significant liver injury is confirmed (for example liver transaminase levels greater than 5-fold the ULN and/or serum bilirubin elevations).
Maltese: Pazjenti li jiżviluppaw sintomi li jissuġġerixxu disfunzjoni tal-fwied, bħalma huma dardir bla spjegazzjoni, rimettar, uġigħ addominali, għeja, anoressija, jew suffejra u/jew awrina skura, għandu jkollhom l-enżimi tal-fwied iċċekkjati u Gilenya għandu jitwaqqaf jekk ikun hemm konferma ta' ħsara sinifikanti fil-kliewi (ngħidu aħna livelli tat-transaminasi tal-fwied 5 darbiet ogħla mill-ULN u/jew żidiet tas-serum tal-bilirubina).
English: Cases of asymptomatic PML based on MRI findings and positive JCV DNA in the cerebrospinal fluid have been reported in patients treated with fingolimod.
Maltese: Kienu rrappurtati każijiet ta' PML asintomatika msejsa fuq ir-riżultati tal-MRI u DNA pożittiv għall-JCV fil-fluwidu ċelebrospinali f'pazjenti ttrattati b'fingolimod.
English: Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the CNS.
Maltese: L-SM li tirkadi u tbatti hija kkaratterizzata b'attakki ripetuti (rikaduti) ta' sintomi relatati mas-sistema nervuża li jirriflettu infjammazzjoni fis-SNĊ.
English: Gilenya has not been studied in multiple sclerosis patients with concomitant diabetes mellitus.
Maltese: Gilenya għadu ma ġiex studjat f'pazjenti bi sklerożi multipla li għandhom dijabete mellitus konkomitanti.
English: Elderly population
Maltese: Adulti:
English: The rate of congenital malformations observed in babies exposed to Gilenya during pregnancy is about 2 times the rate observed in the general population (in whom the rate of congenital malformations is about 2-3%).
Maltese: Ir-rata ta' malformazzjonijiet konġenitali osservati fi trabi esposti għal Gilenya matul ittqala hi ta' madwar darbtejn aktar mir-rata osservata fil-popolazzoni ġenerali (li fihom ir-rata ta' malformazzjonijiet konġenitali hi ta' madwar 2-3%).
English: Cases of cryptococcal meningitis (a fungal infection), sometimes fatal, have been reported in the postmarketing setting after approximately 2-3 years of treatment, although an exact relationship with the duration of treatment is unknown (see section 4.8).
Maltese: Kienu rrappurtati każijiet ta' meninġite kriptokokkali (infezzjoni fungali), kultant fatali, wara li lprodott tqiegħed fis-suq wara madwar 2-3 snin ta' trattament, minkejja li mhijiex magħrufa rrelazzjoni eżatta ma' kemm itul it-trattament (ara sezzjoni 4.8).
English: The approved dosing of 0.5 mg once daily (or 0.25 mg once daily in pediatric patients 10 years of age and above with a body weight of ≤40 kg) when restarting Gilenya should be administered.
Maltese: Għandha tingħata d-doża approvata ta' 0.5 mg darba kuljum (jew 0.25 mg darba kuljum f'pazjenti pedjatriċi minn 10 snin 'il fuq b'piż ta' ≤40 kg) meta terġa' tibda Gilenya.
English: Very rare cases of T-wave inversion have been reported in adult patients treated with fingolimod.
Maltese: Kienu rrappurtati każijiet rari ħafna ta' inverżjoni tal-mewġa T f'pazjenti adulti ttrattati b'fingolimod.
English: How to store Gilenya
Maltese: Kif jaħdem Gilenya
English: Adjusted mean
Maltese: Medja aġġustata
English: Fingolimod treatment with single or multiple doses of 0.5 and 1.25 mg for two weeks is not associated with a detectable increase in airway resistance as measured by FEV1 and forced expiratory flow rate (FEF) 25-75.
Maltese: Il-kura b'fingolimod b'dożi singoli jew multipli ta' 0.5 u 1.25 mg għal ġimagħtejn mhijiex assoċjata ma' żieda li tidher fir-reżistenza tal-passaġġ respiratorju kif imkejjel b'FEV1 u fir-rata tal-fluss espiratorju sfurzat (FEF) ta' 25-75.
English: Stopping therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: - Weight loss.
Maltese: Mhux applikabbli.
English: The majority of T and B lymphocytes regularly traffic through lymphoid organs and these are the cells mainly affected by fingolimod.
Maltese: Minħabba li dan is-sottogrupp ta' limfoċiti normalment ma jgħaddix fl-organi limfatiċi mhuwiex affettwat b'fingolimod.
English: After oral administration, about 81% of the dose is slowly excreted in the urine as inactive metabolites.
Maltese: Wara li tingħata mill-ħalq, madwar 81% tad-doża tgħaddi bil-mod il-mod mal-awrina bħala metaboliti inattivi.
English: • Patient Alert Card
Maltese: • Informazzjoni lit-tobba
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with ARCALYST;
Maltese: • Ir-riskju ta' infezzjonijiet serji, li jinkludu infezzjonijiet opportunistiċi batterjali, virali u fungali f'pazjenti kkurati b'Arcalyst;
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use ARCALYST are provided with a physician information pack containing the following:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (Marketing Authorisation Holder - MAH) għandu jiżgura li, qabel jitpoġġa l-prodott fuq is-suq, it-tobba kollha li huma mistennija li jagħtu riċetta għal/jużaw Arcalyst, jingħataw pakkett ta' informazzjoni li jkun fih dan li ġej:
English: • The unknown safety of ARCALYST in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
Maltese: • Is-sigurtà mhux magħrufa ta' Arcalyst f'nisa tqal u li qed ireddgħu, u għaldaqstant, il-ħtieġa li t-tobba jiddiskutu dan ir-riskju ma' pazjenti jekk dawn joħorġu tqal jew jippjanaw li joħorġu tqal;
English: • The need to measure neutrophil counts prior to initiating treatment, after 1 to 2 months and periodically thereafter while receiving ARCALYST as treatment with ARCALYST should not be initiated in patients with neutropenia;
Maltese: • Il-ħtieġa li jitkejjel l-għadd tan-newtrofili qabel tinbeda l-kura, wara minn xahar sa xahrejn ta' kura, u perjodikament wara dak il-perjodu, meta pazjent ikun qed jirċievi l-kura b'Arcalyst, għax il-kura b'Arcalyst m'għandhiex tinbeda f'pazjenti b'newtropenija;
English: • The role and use of patient alert card.
Maltese: • Kartuna ta' twissija għall-pazjent
English: Rare: cutis laxa (dermatochalasis), allergic dermatitis
Maltese: Rari: cutis laxa (dermatokalasi), dermatite allerġika
English: B-2870 Puurs Belgium
Maltese: B-2870 Puurs Il-Belgju
English: In vitro, the percent bound to rat albumin, human albumin and human serum was 98.4%, 95.4% and 99.1%, respectively.
Maltese: In vitro, il-persentaġġ marbut ma' l-albumina tal-firien, albumina umana u serum uman kien 98.4%, 95.4% u 99.1%, rispettivament.
English: Prostaglandin analogues
Maltese: Analogi ta' prostaglandin
English: Rare: hypersensitivity
Maltese: Rari: sensittività eċċessiva
English: Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac.
Maltese: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac.
English: Date of first authorisation: 11 December 2007 Date of latest renewal: 24 September 2012
Maltese: Data tal-aħħar tiġdid: 24 ta' Settembru 2012
English: Date of first authorisation: 03 May 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 3 ta' Mejju 2013
English: There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
Maltese: Hemm potenzjal ta' cross-sensitivity ta' nepafenac għal acetylsalicylic acid, derivati ta' phenylacetic acid, u NSAIDs oħra.
English: Interactions with other medicinal products: Neither nepafenac nor amfenac inhibit any of the major human cytochrome P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 and 3A4) metabolic activities in vitro at concentrations up to 3000 ng/ml.
Maltese: La nepafenac u lanqas amfenac ma jinibixxu l-ebda millattivitajiet metaboliċi in vivo taċ-ċitokromju maġġuri uman P450 (CYP1A2, 2C9, 2C19, 2D6, 2E1 u 3A4) f'konċentrazzjonijiet sa 3000 ng/ml.
English: The maximum mean aqueous humour concentrations were observed at the 1 hour time-point (nepafenac 177 ng/ml, amfenac 44.8 ng/ml).
Maltese: Il-konċentrazzjonijiet medji massimi fl-aqueous humour kienu osservati fil-punt ta' ħin ta' siegħa (nepafenac 177 ng/ml, amfenac 44.8 ng/ml).
English: The following adverse reactions 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 <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin 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 <1/1,000), rari ħafna (<1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Maltese: Benzalkonium chloride kien irrapportat li jikkawża punctate keratopathy u/jew keratopathy ulċerattiva, tossika.
English: Amfenac has a high affinity toward serum albumin proteins.
Maltese: Amfenac għandu affinità għolja lejn proteini ta' l-albumina fis-serum.
English: Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs).
Maltese: Sensittività eċċessiva għall-mediċini anti-infjammatorji mhux sterojdi (NSAIDs) oħra.
English: An additional drop should be administered 30 to 120 minutes prior to surgery.
Maltese: Qatra addizzjonali għandha tingħata 30 sa 120 minuta qabel il-kirurġija.
English: Following a single dose of NEVANAC in 25 cataract surgery patients, aqueous humour concentrations were measured at 15, 30, 45 and 60 minutes post-dose.
Maltese: Wara doża waħda ta' NEVANAC f'25 pazjent li kellhom kirurġija tal-katarretti, konċentrazzjonijiet fl-aqueous humour kienu mkejjla 15, 30, 45 u 60 minuta wara d-doża.
English: Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Purified water
Maltese: Sodium hydroxide u/jew hydrochloric acid (għall-aġġustament tal-pH) Ilma ppurifikat
English: The mean steady-state plasma Cmax for nepafenac and for amfenac were 0.847 ± 0.269 ng/ml and 1.13 ± 0.491 ng/ml, respectively, following ocular administration.
Maltese: Cmax medja fil-plażma fi stat fiss għal nepafenac u għal amfenac kienet ta' 0.847 ± 0.269 ng/ml u 1.13 ± 0.491 ng/ml, rispettivament, wara għoti ġo l-għajn.
English: Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug.
Maltese: Nepafenac huwa prodrug anti-infjammatorju mhux sterojd, u analġesiku.
English: Adults, including the elderly
Maltese: Adulti, inkluż l-anzjani
English: Mannitol E421, carbomer, sodium chloride, tyloxapol, disodium edetate, benzalkonium chloride, sodium hydroxide and/or hydrochloric acid and purified water.
Maltese: Mannitol E421, carbomer, sodium chloride, tyloxapol, disodium edetate, benzalkonium chloride, sodium hydroxide u/jew hydrochloric acid u ilma ppurifikat.
English: Light yellow to dark orange uniform suspension, pH 6.8 (approximately).
Maltese: Suspensjoni uniformi, safra ċara sa oranġjo skur, pH 6.8 (bejn wieħed u ieħor).
English: NEVANAC contains benzalkonium chloride
Maltese: NEVANAC fih benzalkonium chloride
English: Boric acid, propylene glycol, carbomer, sodium chloride, guar, carmellose sodium, disodium edetate, benzalkonium chloride, sodium hydroxide and/or hydrochloric acid and purified water.
Maltese: Boric acid, propylene glycol, carbomer, sodium chloride, guar, carmellose sodium, disodium edetate, benzalkonium chloride, sodium hydroxide u/jew hydrochloric acid u ilma ppurifikat.
English: S.A. Alcon-Couvreur N.V. Rijksweg 14
Maltese: S.A. Alcon-Couvreur N.V.
English: 1 x 3 ml - round bottle
Maltese: 1 x 3 ml - tond Flixkun
English: The corresponding percentages in integrated analysis of the 2 studies were 15.9% in vehicle group and 4.1% in NEVANAC group, p<0.001).
Maltese: Il-perċentwali li jikkorrispondu fl-analiżi integrata taż-żewġ studji kienu 15.9% fil-grupp tal-eċċipjent u 4.1% fil-grupp ta' NEVANAC, p<0.001).
English: Each ml of suspension contains 0.05 mg of benzalkonium chloride.
Maltese: Kull ml ta' suspensjoni fih 0.05 mg ta' benzalkonium chloride.
English: These findings indicate rapid corneal penetration.
Maltese: Dawn is-sejbiet jindikaw penetrazzjoni rapida fil-korneja.
English: Prevention and treatment of postoperative pain and inflammation associated with cataract surgery The efficacy and safety of NEVANAC 3 mg/ml in the prevention and treatment of postoperative pain and inflammation associated with cataract surgery has been demonstrated in two masked, double blind, placebo-controlled clinical trials in a total of 1339 patients.
Maltese: L-effikaċja u s-sigurtà ta' NEVANAC 3 mg/ml fil-prevenzjoni u l-kura ta' uġigħ u infjammazzjoni wara operazzjoni assoċjati ma' kirurġija tal-katarretti intwerew f'żewġ provi kliniċi masked, double blind u kkontrollati bil-plaċebo f'total ta' 1,339 pazjent.
English: NEVANAC contains the active substance nepafenac, and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Maltese: NEVANAC fih is-sustanza attiva nepafenac, u jagħmel parti minn grupp ta' mediċini msejħa mediċini anti-infjammatorji mhux sterojdi (NSAIDs).
English: A significantly greater percentage of patients achieved improvement of 15 or more letters at Day 14 and maintained the improvement through Day 90 in NEVANAC 3 mg/ml group (61.7%) compared to vehicle group (43%) in one study; the percentage of subjects was similar in the 2 treatment groups for this endpoint in the second study (48.8% in NEVANAC group and 50.5% in vehicle group).
Maltese: Fi studju wieħed perċentwali sinifikatament ogħla ta' pazjenti laħqu titjib ta' 15-il ittra jew aktar f'Jum 14 u żammew it-titjib sa Jum 90 fil-grupp ta' NEVANAC 3 mg/ml (61.7%) meta mqabbel mal-grupp tal-eċċipjent (43%); il-perċentwal ta' individwi kien simili fiż-żewġ gruppi ta' trattament għal dan il-punt finali fit-tieni studju (48.8% filgrupp ta' NEVANAC u 50.5% fil-grupp tal-eċċipjent).
English: Pain free rates in the NEVANAC group were 89% and 91% compared to 40% and 50% of patients on vehicle.
Maltese: Rati ta' nuqqas ta' uġigħ fil-grupp ta' NEVANAC kienu ta' 89% u 91% meta mqabbla ma' 40% u 50% tal-pazjenti fuq l-istess suspensjoni mingħajr mediċina.
English: Eye drops, suspension
Maltese: Qtar għall-għajnejn, suspensjoni.
English: In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions (see section 5.2).
Maltese: Studji in vitro wrew potenzjal baxx ħafna ta' interazzjoni ma' prodotti mediċinali oħra u nterazzjonijiet ta' twaħħil mal-proteini (ara sezzjoni 5.2).
English: Other medicines and NEVANAC
Maltese: Mediċini oħra u NEVANAC
English: In integrated analysis of the 2 studies, the percentage of subjects with 15 letter improvement at Day 14 and maintained to Day 90 was higher in NEVANAC 3 mg/ml group (55.4%) compared to vehicle group (46.7%, p=0.003).
Maltese: Fl-analiżi integrata taż-żewġ studji, ilperċentwal ta' individwi b'titjib ta' 15-il ittra f'Jum 14 u miżmum sa Jum 90 kien ogħla fil-grupp ta' NEVANAC 3 mg/ml (55.4%) meta mqabbel mal-grupp tal-eċċipjent (46.7%, p=0.003).
English: 1 x 3 ml - oval bottle
Maltese: 1 x 3 ml - ovali Flixkun
English: - Prevention and treatment of postoperative pain and inflammation associated with cataract surgery - Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients (see section 5.1)
Maltese: - Prevenzjoni u kura ta' uġigħ u infjammazzjoni ta' wara operazzjoni assoċjati ma' kirurġija tal-katarretti - Tnaqqis fir-riskju ta' edima makulari ta' wara operazzjoni assoċjata ma' kirurġija tal-katarretti f'pazjenti dijabetiċi (ara sezzjoni 5.1).
English: The second most abundant plasma metabolite was identified as 5-hydroxy nepafenac, representing approximately 9% of total radioactivity at Cmax.
Maltese: It-tieni metabolita l-aktar abbundanti fil-plażma kien identifikat bħala 5-hydroxy nepafenac, li jirrappreżenta madwar 9% tar-radjuattività totali ta' Cmax.
English: In clinical studies involving 2314 patients receiving NEVANAC 1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.
Maltese: Fi studji kliniċi fejn ħadu sehem 2,314 pazjent li kienu qed jirċievu NEVANAC 1 mg/ml l-aktar reazzjonijiet avversi komuni kienu keratite ittikkjata, sensazzjoni ta' oġġett barrani fl-għajn, u qxur fix-xifer tal-kappell tal-għajn li seħħew f'bejn 0.4% u 0.2% tal-pazjenti.
English: In clinical trials, patients were treated for up to 21 days with NEVANAC 3 mg/ml eye drops, suspension (see section 5.1).
Maltese: Fi provi kliniċi, il-pazjenti kienu kkurati sa 21 ġurnata b'NEVANAC 3 mg/ml qtar għall-għajnejn, suspensjoni (ara sezzjoni 5.1).
English: NEVANAC 1 mg/ml is indicated in adults for:
Maltese: NEVANAC 1 mg/ml hu indikat f'adulti għal:
English: • General side effects: vomiting, increased blood pressure.
Maltese: • Effetti sekondarji ġenerali: rimettar, żieda fil-pressjoni.
English: This medicine contains 0.25 mg benzalkonium chloride in each 5 ml which is equivalent to 0.05 mg/ml.
Maltese: Din il-mediċina fiha 0.25 mg benzalkonium chloride f'kull 5 ml li hu ekwivalenti għal 0.05 mg/ml.
English: Ocular adverse reactions in diabetic patients may occur at a higher frequency than observed in the general population (see section 4.4).
Maltese: Reazzjonijiet avversi flgħajnejn f'pazjenti dijabetiċi jistgħu jseħħu bi frekwenza akbar minn dik osservata fil-popolazzjoni ġenerali (ara sezzjoni 4.4).
English: Ex vivo, a single topical ocular dose of nepafenac was shown to inhibit prostaglandin synthesis in the iris/ciliary body (85%-95%) and the retina/choroid (55%) for up to 6 hours and 4 hours, respectively.
Maltese: Fil-fniek, nepafenac intwera li jinibixxi l-kollass tad-diviżorju ta' bejn id-demm u r-retina, flimkien mas-soppressjoni tas-sintesi ta' PGE2. Ex vivo, doża waħda topika ġo l-għajn ta' nepafenac intweriet li tinibixxi s-sintesi ta' prostaglandin fil-ħabba/organu ċiljari (85%-95%) u fir-retina/korojd (55%) għallperjodu sa 6 sigħat u 4 sigħat, rispettivament.
English: 1 ml of suspension contains 1 mg nepafenac.
Maltese: Ml ta' suspensjoni fih 1 mg nepafenac.
English: Nepafenac undergoes relatively rapid bioactivation to amfenac via intraocular hydrolases.
Maltese: Nepafenac jgħaddi minn bioattivazzjoni relattivament rapida għal amfenac permezz ta' hydrolases ġo l-għajn.
English: This medicine contains 0.15 mg benzalkonium chloride in each 3 ml which is equivalent to 0.05 mg/ml.
Maltese: Din il-mediċina fiha 0.15 mg benzalkonium chloride f'kull 3 ml li hu ekwivalenti għal 0.05 mg/ml.
English: Pharmacotherapeutic group: Ophthalmologicals, anti-inflammatory agents, non-steroids, ATC code: S01BC10
Maltese: Oftalmoloġiċi, Sustanzi anti-infjammatorji, mhux sterojdi, Kodiċi ATC:
English: The other reported adverse reactions were corneal epithelium defect and allergic dermatitis which occurred in 1% and 0.5% of patients, respectively both adverse reactions with a frequency category of uncommon.
Maltese: Ir-reazzjonijiet avversi l-oħra rrappurtati kienu difett fl-epitelju tal-kornea u dermatite allerġika li seħħew f'1% u 0.5% tal-pazjenti, rispettivament; iżżewġ reazzjonijiet avversi kellhom kategorija ta' frekwenza mhux komuni.
English: The majority of hydrolytic conversion is in the retina/choroid followed by the iris/ciliary body and cornea, consistent with the degree of vascularised tissue.
Maltese: Il-maġġoranza tal-bidla idrolitika hija fir-retina/korojd segwita mill-ħabba/organu ċiljari u l-korneja, konsistenti mal-kwantità ta' tessut vaskularizzat.
English: What NEVANAC contains - The active substance is nepafenac.
Maltese: • Is-sustanza attiva hi nepafenac.