FrancophonIA/ELRC3.0 huggingface dataset:
English: Hydrochlorothiazide crosses the placenta.
Maltese: Hydrochlorothiazide jaqsam il-plaċenta.
English: Irbesartan/Hydrochlorothiazide Teva is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: Il-hydrochlorothiazide li jinsab f'din il-mediċina tista' tipproduċi riżultat pożittiv f'test ta' antidoping Tfal u adolexxenti
English: Irbesartan/Hydrochlorothiazide Teva is not indicated in patients with severe hepatic impairment.
Maltese: Irbesartan/Hydrochlorothiazide Teva mhux indikat f'pazjenti b'indeboliment epatiku sever.
English: pH: 8.1-8.5; osmolality: 270-330 mOsmol/kg
Maltese: pH: 8.1-8.5; ożmolalità: 270-330 mOsmol/kg
English: In vitro, the 99.8% were bound to proteins in human plasma.
Maltese: In vitro, 99.8% weħel mal-proteini fil-plażma umana.
English: - The active substance is bromfenac.
Maltese: - Is-sustanza attiva hi bromfenac.
English: MedDRA system organ Frequency
Maltese: Sistema tal-klassifika tal-organi MedDRA
English: Czech Republic czech.info@valeant.com
Maltese: Repubblika Ċeka czech.info@valeant.com
English: Use of contact lenses
Maltese: L-użu tal-contact lenses
English: Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.
Maltese: acetylsalicylic acid, ibuprofen, ketoprofen, diclofenac.
English: Each ml of solution contains 50 micrograms of benzalkonium chloride.
Maltese: Kull ml ta' soluzzjoni fiha 50 mikrogramma ta' benzalkonium chloride.
English: Photophobia
Maltese: Fotofobija
English: Duration of treatment
Maltese: Durazzjoni tat-trattament
English: Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH Brunsbütteler Damm 165-173 13581 Berlin
Maltese: Fabrik GmbH Brunsbütteler Damm 165-173 13581 Berlin
English: Date of first authorisation: 18.05.2011 Date of latest renewal: 11.01.2016
Maltese: Data tal-aħħar tiġdid: 11.01.2016
English: The following adverse reactions were 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).
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), jew rari ħafna (<1/10,000).
English: Corneal perforation* Corneal ulcer* Corneal erosion, serious* Scleromalacia* Corneal infiltrates* Corneal disorder * Corneal scar*
Maltese: Perforazzjoni tal-kornea* Ulċera tal-kornea* Erożjoni tal-kornea, serja* Skleromalaċija* Infiltrati fil-kornea* Disturb fil-kornea* Ċikatriċi fil-kornea*
English: - The other ingredients are: boric acid, borax, sodium sulphite anhydrous (E221), benzalkonium chloride (see section 2), tyloxapol, povidone (K30), disodium edetate, water for injection, sodium hydroxide (to keep acidity levels normal).
Maltese: - Is-sustanzi l-oħra huma: boric acid, borax, sodium sulphite anhydrous (E221), benzalkonium chloride (ara sezzjoni 2), tyloxapol, povidone (K30), disodium edetate, ilma għall-injezzjoni, sodium hydroxide (biex iżomm il-livelli tal-aċidità normali).
English: Two Phase II multicentre, randomised, double-masked, parallel group studies were conducted in Japan, and two Phase III multicentre, randomised (2:1), double-masked, parallel group, placebocontrolled studies were conducted in the US to assess the clinical safety and efficacy of Yellox dosed twice daily in the treatment of post-operative inflammation in patients undergoing cataract surgery.
Maltese: III, multiċentriċi, li fihom il-pazjenti ntgħażlu b'mod każwali (2:1), double-masked, paralleli, u kkontrollati bi plaċebo fl-Istati Uniti biex jiġu evalwati s-sigurtà u l-effikaċja klinika ta' Yellox mogħti darbtejn kuljum fil-kura ta' infjammazzjoni ta' wara l-operazzjoni f'pazjenti li kienu qed jagħmlu operazzjoni tal-katarretti.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1..
English: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
Maltese: Sensittività inkroċjata Hemm il-potenzjali ta' sensittività inkroċjata għal acetylsalicylic acid, derivattivi ta' phenylacetic acid, u NSAIDs oħra.
English: DK/NO/FI/SE/IS
Maltese: DK/NO/FI/SE/IS Bausch & Lomb Nordic AB
English: Pregnant rabbits treated orally with 7.5 mg/kg/day (7500 times the recommended ophthalmic dose) caused increased postimplantation loss (see section 4.6).
Maltese: Fi fniek tqal li nagħataw kura orali b'7.5 mg/kg/kuljum (7,500 darba tad-doża oftalmika rakkomandata) seħħet żieda fit-telf wara l-impjantazzjoni (ara sezzjoni 4.6).
English: Yellox contains bromfenac and belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Yellox fih bromfenac u jappartjeni għal grupp ta' mediċini msejħa mhux sterojdi antiinfjammatorji (NSAIDs).
English: PharmaSwiss Česká republika s.r.o.
Maltese: Česká republika s.r.o.
English: Boric acid, borax, sodium sulphite anhydrous (E221) (see the package leaflet for further information), tyloxapol, povidone, disodium edetate, benzalkonium chloride (see the package leaflet for further information), water for injections, sodium hydroxide (for pH adjustment)
Maltese: Boric acid, borax, sodium sulphite anhydrous (E221) (ara l-fuljett ta' tagħrif għal aktar informazzjoni), tyloxapol, povidone, disodium edetate, benzalkonium chloride (ara l-fuljett ta' tagħrif għal aktar informazzjoni), ilma għall-injezzjonijiet sodium hydroxide (għal aġġustament tal-pH)
English: Pregnancy , breastfeeding and fertility
Maltese: Tqala, treddigħ u fertilità
English: Water for injections Sodium hydroxide (for pH adjustment)
Maltese: Ilma għall-injezzjonijiet Sodium hydroxide (għal aġġustament għal pH)
English: Retinal exudates
Maltese: Reazzjonijiet avversi
English: EU/1/11/692/001
Maltese: NUMRU TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/692/001
English: One drop contains approximately 33 micrograms bromfenac.
Maltese: Qatra waħda fiha madwar 33 mikrogramma ta' bromfenac.
English: Bromfenac efficiently permeates the cornea of cataract patients: A single dose resulted in a mean peak aqueous humour concentrations of 79±68 ng/ml at 150-180 minutes after dosing.
Maltese: Doża waħda rriżultat f'medja tal-ogħla livell ta' konċentrazzjonijiet fl-aqueous humour ta' 79±68 ng/ml wara 150-180 minuta mid-dożaġġ.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornamenti sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Other medicines and Yellox
Maltese: Mediċini oħra u Yellox
English: Bausch & Lomb Nordic AB
Maltese: Bausch & Lomb-IOM S.p.A.
English: The most common or most important reactions in the pooled studies were abnormal sensation in eye (0.5%), corneal erosion (mild or moderate) (0.4%), eye pruritus (0.4%), eye pain (0.3%) and eye redness (0.3%).
Maltese: L-aktar reazzjonijiet komuni jew l-aktar importanti fl-istudji pooled kienu sensazzjoni anormali fl-għajnejn (0.5%), erożjoni tal-kornea (ħafifa jew moderata) (0.4%), prurite talgħajnejn (0.4%), uġigħ fl-għajnejn (0.3%) u ħmura fl-għajnejn (0.3%. L-effetti mhux mixtieqa fil-kornea kienu osservati biss fil-popolazzjoni Ġappuniża.
English: Kypropharm Ltd. Τηλ: + 357 22 43 46 99
Maltese: Τηλ: + 357 22 43 46 99
English: Pharmacotherapeutic group: Ophtalmologicals, Antiinflammatory agents, non-steroids, ATC code: S01BC11.
Maltese: Oftalmoloġiċi, sustanzi antiinfjammatorji, mhux sterojdi, Kodiċi ATC:
English: Yellox is indicated in adults for the treatment of postoperative ocular inflammation following cataract extraction .
Maltese: Yellox hu indikat fl-adulti għat-trattament ta' infjammazzjoni okulari postoperattiva wara ttneħħija ta' katarretti.
English: There was significantly less anterior chamber cells and flare within the first 2 weeks post-surgery (85.1% of patients with flare score of ≤1) vs. placebo (52%).
Maltese: 1% tal-pazjenti b'punteġġ ta' aggravament ta' <1) vs. il-plaċebo (52%).
English: In vitro studies indicate that bromfenac is mainly metabolised by CYP2C9, which is absent in both iris-ciliary body and retina/choroid and the level of this enzyme in the cornea is less than 1% compared to the corresponding hepatic level.
Maltese: In vitro, l-istudji jindikaw li bromfenac hu prinċipalment metabolizzat minn CYP2C9, li hi assenti kemm fil-korp tal-ħabba tal-għajn/organu ċiljari u r-retina/korojdi, u l-livell ta' din lenżima fil-kornea hi inqas minn 1% meta mqabbel mal-livell epatiku korrispondenti.
English: The IC50values were lower for Bromfenac (1.1 μM) than for indometacin (4.2 μM) and pranoprofen (11.9 μM) Bromfenac at concentrations of 0.02%, 0.05%, 0.1% and 0.2% inhibited almost all signs of ocular inflammation in an experimental uveitis model in rabbits.
Maltese: Bromfenac f'konċentrazzjonijiet ta' 0.02%, 0.05%, 0.1% u 0.2% inibixxa kważi s-sinjali kollha ta' infjammazzjoni okulari f'mudell sperimentali ta' uveite fil-fniek.
English: Hypersensitivity to bromfenac or to any of the excipients listed in section 6.1, or to other nonsteroidal anti-inflammatory medicinal products (NSAIDs).
Maltese: Sensittività eċċessiva għal bromfenac jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1, jew għal prodotti mediċinali oħra mhux sterojdi u antiinfjammatorji (NSAIDs).
English: Visual acuity reduced Haemorrhagic retinopathy Corneal epithelium defect** Corneal erosion (mild or moderate) Corneal epithelium disorder Corneal oedema
Maltese: Tnaqqis fiċ-ċarezza tal-vista Retinopatija emorraġika Difett fl-epitelju tal-kornea** Erożjoni tal-kornea (ħafifa jew moderata) Disturb fl-epitelju tal-kornea Edema tal-kornea
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: 5.1 Tagħrif farmakodinamiku
English: Ingestion of the 5 ml bottle content corresponds to an oral dose of less than 5 mg bromfenac, which is 30 times lower than daily dose of bromfenac oral formulation formerly used.
Maltese: Inġestjoni tal-kontenut ta' flixkun ta' 5 ml jikkorrispondi għal doża orali ta' inqas minn 5 mg bromfenac, li huwa 30 darba inqas minn doża ta' kuljum ta' formulazzjoni orali ta' bromfenac użata preċedentement.
English: Several conjugated and unconjugated metabolites have been identified with the cyclic amide being the major urinary metabolite.
Maltese: Ħafna metaboliti konjugati u mhux konjugati kienu identifikati, bl-amide ċikliku li kien il-metabolit maġġuri urinarju.
English: Concentrations were maintained for 12 hours in aqueous humour with measurable levels up to 24 hours in major ocular tissues including the retina.
Maltese: Il-konċentrazzjonijiet inżammu għal 12-il siegħa fl-aqueous humour b'livelli li setgħu jitkejlu sa 24 siegħa f'tessuti okulari maġġuri, inkluża r-retina.
English: 1 ml of solution contains 0.9 mg bromfenac (as sodium sesquihydrate).
Maltese: U KWANTITATTIVA 1 ml tas-soluzzjoni fih 0.9 mg ta' bromfenac, (bħala sodium sesquihydrate).
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilmediċini: http://www.ema.europa.eu/
English: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: Yellox 0.9 mg/ml eye drops solution bromfenac
Maltese: Yellox 0.9 mg/ml qtar għall-għajnejn soluzzjoni bromfenac
English: Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity which is thought to be due to its ability to block prostaglandin synthesis by inhibiting primarily cyclooxygenase 2 (COX-2).
Maltese: Bromfenac hi mediċina antiinfjammatorja mhux sterojdi (NSAID) li għandha attività antiinfjammatorja li hu maħsub li hi riżultat tal-ħila tagħha li timblokka s-sintesi ta' prostaglandin billi tinibixxi primarjament cyclooxygenase 2 (COX-2). Cyclooxygenase 1 (COX-1) hu inibit biss fi grad minuri.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni talprodott mediċinali.
English: Tel: +385 1 6311 833
Maltese: PharmaSwiss d.o.o. Tel: +385 1 6311 833
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE Yellox
English: These comprised 3 (0.3%) patients with mild corneal erosion, 2 (0.2%) patients with eyelid oedema and 1 (0.1%) patient each with abnormal sensation in eye, corneal oedema, or eye pruritus.
Maltese: Dawn kienu jinkludu 3 (0.3%) pazjenti li kellhom erożjoni ħafifa tal-kornea, 2 (0.2%) pazjenti li kellhom edema fil-kappell tal-għajn u 1 (0.1%) pazjent f'kull popolazzjoni li kellu sensazzjoni anormali fl-għajnejn, edema tal-kornea jew prurite fl-għajnejn.
English: Pharmaswiss Hellas A.E. Τηλ: +30 210 8108 460
Maltese: Τηλ: +30 210 8108 460
English: Yellox may be prescribed to breast-feeding woman and have no important influence on fertility.
Maltese: Yellox jista' jiġi preskritt lil mara li qed tredda' u ma jkollhom ebda influwenza importanti fuq il-fertilità.
English: Fertility
Maltese: Frekwenza
English: Yellox 0.9 mg/ml eye drops solution
Maltese: Yellox 0.9 mg/ml qtar għall-għajnejn soluzzjoni
English: Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus and 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: L-esperjenza wara t-tqegħid fis-suq b'NSAIDs topiċi tissuġġerixxi li l-pazjenti b'operazzjonijiet ikkumplikati tal-għajnejn, denervazzjoni tal-kornea, difetti fl-epitelju tal-kornea, dijabete mellitus u mard fis-superfiċje tal-għajnejn, eż. sindrome tal-għajnejn xotti, artrite rewmatojda jew operazzjoni ripetuta fl-għajnejn f'perijodu qasir ta' żmien, jistgħu jkunu f'riskju ikbar ta' reazzjonijiet avversi tal-kornea li jistgħu jsiru ta' periklu għall-vista.
English: Therefore, do not wear contact lenses whilst using Yellox.
Maltese: Għalhekk, tilbisx contact lenses waqt li tkun qed tuża Yellox.
English: Benzalkonium chloride is known to discolour soft contact lenses.
Maltese: Benzalkonium chloride hu magħruf li jikkawża bidla fil-kulur tal-contact lenses rotob .
English: A significantly greater proportion of patients in the Yellox group 64.0% vs. 43.3% in the placebo group (p<0.0001) experienced complete clearance of ocular inflammation at study day 15.
Maltese: Proporzjon ogħla b'mod sinifikanti ta' pazjenti fil-ġrupp ta' Yellox 64.0% vs. 43.3% fil-grupp tal-plaċebo (p<0.
English: *Serious reports from post-marketing experience of more than 20 million patients ** Observed with four times daily dose
Maltese: * Rapporti serji minn esperjenza ta' wara t-tqegħid fis-suq ta' aktar minn 20 miljun pazjent ** Osservat b'doża erba' darbiet kuljum
English: eye drops, solution 1x5 ml
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT qtar għall-għajnejn, soluzzjoni 1x5 ml
English: Use in adults, including the elderly
Maltese: Użu fl-adulti, inklużi l-anzjani
English: PharmaSwiss d.o.o.
Maltese: Pharmaswiss Hellas A.E.
English: No biological relevant melanin binding was observed in vitro.
Maltese: Ma kien osservat l-ebda twaħħil rilevanti bijoloġiku ma' melanin in vitro.
English: In susceptible patients, continued use of topical NSAIDs, including bromfenac may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation.
Maltese: Fil-każ ta' pazjenti suxxettibbli, l-użu kontinwu ta' NSAIDs topiċi, inkluż bromfenac jista' jwassal għal kollass tal-epitelju, kornea li tirqaq, erożjoni tal-kornea, ulċerazzjoni tal-kornea jew perforazzjoni tal-kornea.
English: PHARMACEUTICAL FORM
Maltese: FARMAKOLOĠIKU
English: One ml of solution contains 0.9°mg bromfenac (as sodium sesquihydrate).
Maltese: Ml wieħed tas-soluzzjoni fih 0.9 ° mg ta' bromfenac (bħala sodium sesquihydrate).
English: Bromfenac
Maltese: PharmaSwiss
English: Excipients
Maltese: Pożoloġija
English: No abnormal findings or adverse reactions of clinical concern were noted upon administration of two drops 2mg/ml solution four times a day for the period of up to 28 days.
Maltese: L-ebda sejbiet anormali jew reazzjonijiet avversi ta' tħassib kliniku kienu nnotati fuq amministrazzjoni ta' żewġ qatriet 2mg/ml soluzzjoni erba' darbiet kuljum għall-perijodu sa 28 jum.
English: Foreign body sensation in the eye, redness and inflammation of the eye, damage and inflammation of the surface of the eye, eye discharge, itching, irritation or pain of the eye, swelling or bleeding of the eyelid, impaired vision due to inflammation, floaters or moving spots before the eyes or diminishing vision that can indicate bleeding or damage of the back of the eye (retina), ocular discomfort, sensitivity to light, reduced or blurred vision, swelling of the face, cough, nosebleeding or runny nose.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw minn 1 sa 100 persuna) Tħoss xi ħaġa barranija fl-għajnejn, ħmura u infjammazzjoni tal-għajnejn, ħsara u infjammazzjoni tas-superfiċje tal-għajnejn, tnixxija mill-għajnejn, ħakk fl-għajnejn jew uġigħ fl-għajnejn, nefħa jew ħruġ ta' demm f'il-kappell tal-għajn, vista impedita minħabba infjammazzjoni, floaters jew tikek li jiċċaqilqu quddiem l-għajnejn jew tnaqqis fil-vista li jista' jindika ħruġ ta' demm jew ħsara fuq in-naħa ta' wara tal-għajn (retina), skomfort fl-għajnejn, sensittività għad-dawl jew vista mċajpra, nefħa tal-wiċċ, sogħla, tinfaraġ jew imnieħer li jnixxi.
English: Yellox is for ocular use.
Maltese: Tużax Yellox iktar minn ġimgħatejn.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: After oral administration of 14C-bromfenac to healthy volunteers, urinary excretion was found to be the major route of radioactive excretions, accounting for approximately 82% while faecal excretion represented approximately 13% of the dose.
Maltese: Wara l-għoti orali ta' 14C-bromfenac lil voluntiera b'saħħithom, instab li t-tneħħija fl-awrina kienet ir-rotta maġġuri tat-tneħħija radjuattiva, u dan jirrappreżenta madwar 82% tat-tneħħija, filwaqt li t-tneħħija fl-ippurgar kienet tirrappreżenta madwar 13% tad-doża.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Yellox in all subsets of the paediatric population in postoperative ocular inflammation (see section 4.2 for information on paediatric use)
Maltese: Popolazzjoni pedjatrika L-Aġenzija Ewropeja dwar il-Mediċini (EMA) irrinunzjat għall-obbligu li jigu ppresentati rriżultati tal-istudji b'Yellox f'kull sett tal-popolazzjoni pedjatrika fl-infjammazzjoni okulari ta' wara l-operazzjoni (ara sezzjoni 4.2 għal informazzjoni fuq l-użu pedjatriku)
English: Excipient(s) with known effect:
Maltese: Eċċipjent b'effett magħruf:
English: The difference in the rate of inflammation clearance showed as early as day 3.
Maltese: Id-differenza fir-rata tal-fejqan tal-infjammazzjoni dehret sa mit-tielet ġurnata.
English: 5 ml solution in a polyethylene squeeze bottle with a dropper-tip and a polyethylene screw cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Soluzzjoni ta' 5 ml fi flixkun tal-polyethylene li jingħafas, b'ponta tat-tqattir u għatu talpolyethylene bil-kamini.
English: Yellox is a clear yellow liquid (solution) supplied in a pack containing one 5 ml plastic bottle with a screw cap.
Maltese: Kif jidher YelloxYELLOX u l-kontenut tal-pakkettYellox hu likwidu (soluzzjoni) isfar ċar disponibbli f'pakkett li fih flixkun wieħed tal-plastik ta' 5 ml b'għatu bil-kamin.
English: However, because of the known effects of prostaglandin biosynthesis-inhibiting medicinal products on the foetal cardiovascular system (closure of ductus arteriosus), the use of Yellox during third trimester pregnancy should be avoided.
Maltese: Madankollu, minħabba l-effetti magħrufa tal-prodotti mediċinali li jinibixxu l-bijosintesi ta' prostaglandin fuq is-sistema kardjovaskulari tal-fetu (għeluq tad-ductus arteriosus), l-użu ta' Yellox matul it-tielet trimestru tat-tqala għandu jiġi evitat.
English: Based on clinical data available, a total of 3.4% of patients experienced one or more adverse reactions.
Maltese: Ibbażat fuq dejta klinika disponibbli, total ta' 3.4% tal-pazjenti kellhom reazzjoni avversa waħda jew aktar.
English: In a large, well-controlled study that was conducted in Japan, Yellox was shown to be as effective as pranoprofen ophthalmic solution.
Maltese: Fi studju kbir, ikkontrollat tajjeb li sar fil-Ġappun, intwera li Yellox kien effettiv daqs pranoprofen soluzzjoni oftalmika.
English: - Benzalkonium chloride is a preservative which may cause eye irritation or eye surface problems.
Maltese: Benzalkonium chloride huwa preservattiv li jista' jikkawża irritazzjoni fl-għajnejn jew problemi fis-superfiċje tal-għajn.
English: In vitro, bromfenac inhibited the synthesis of prostaglandins in the rabbit iris ciliary body.
Maltese: Fertilità Ma ġew osservati l-ebda effetti ta' bromfenac fuq il-fertilità fi studji fuq l-annimali.
English: How to store Yellox
Maltese: X'fih Yellox
English: Eyelid oedema
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: Yellox contains sodium sulphite and benzalkonium chloride
Maltese: X'għandek tkun taf qabel ma tuża Yellox
English: Bromfenac shows high binding to plasma proteins.
Maltese: Bromfenac juri livell għoli ta' twaħħil mal-proteini fil-plażma.
English: Eye redness
Maltese: Bijotrasformazzjoni
English: Nasal sinus drainage
Maltese: Soluzzjoni safra ċara.
English: Package leaflet: Information for the user Yellox 0.9 mg/ml eye drops, solution
Maltese: Informazzjoni għall-utent Yellox 0.9 mg/ml qtar għall-għajnejn, soluzzjoni Bromfenac
English: Asthma*
Maltese: Ażżma*
English: Animal studies have shown excretion of bromfenac in breast milk when applied orally at doses of 2.35 mg/kg which is 2350 times the recommended ophthalmic dose.
Maltese: Studji fuq l-annimali wrew it-tneħħija ta' bromfenac fil-ħalib tas-sider meta ġie applikat mill-ħalq f'dożi ta' 2.35 mg/kg li huma 2,350 darba tad-doża oftalmika rakkomandata.
English: - Put yourself in a comfortable and stable position.
Maltese: - Poġġi f'pożizzjoni komda u stabbli.
English: Yellox is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other medicinal products with prostaglandin synthetase inhibiting activity.
Maltese: Yellox hu kontraindikat f'pazjenti li jkollhom attakki tal-ażżma, urtikarja, jew rinite akuta li jiġu kkawżati minn acetylsalicylic acid jew minn prodotti mediċinali oħra li jinibixxu l-attività ta' prostaglandin synthetase.
English: Hepatic and renal impairment Yellox has not been studied in patients with hepatic disease or renal impairment.
Maltese: Indeboliment epatiku u renali Yellox ma ġiex studjat f'pazjenti li jbatu minn mard epatiku jew indeboliment renali.
English: Tel: + 386 1 2364 700
Maltese: PharmaSwiss d.o.o. Tel: + 386 1 2364 700