FrancophonIA/ELRC3.0 huggingface dataset:
English: Ketorolac is an NSAID that inhibits both cyclooxygenase enzymes (COX1 and COX2), reducing pain and inflammation by decreasing tissue concentrations of prostaglandins resulting from surgical trauma.
Maltese: Ketorolac huwa NSAID li jinibixxi ż-żewġ enzimi ċikloossiġenasi (COX1 u COX2), inaqqas l-uġigħ u l-infjammazzjoni billi jnaqqas il-konċentrazzjonijiet ta' prostaglandini fit-tessut b'riżultat ta' trawma kirurġika.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Do not store above 25 ˚C.
Maltese: Taħżinx f'temperaturi ogħla minn 25 ºC.
English: No data are available.
Maltese: M'hemmx data dwar l-użu ta' Omidria f'nisa tqal.
English: Non-clinical data reported in the literature for the individual components in Omidria revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development.
Maltese: Data mhux klinika rrapportata fir-riċensjoni għall-komponenti individwali f'Omidria ma wriet l-ebda periklu speċjali għall-bnedmin, abbażi ta' studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp.
English: It contains the active substances phenylephrine and ketorolac.
Maltese: Fih s-sustanzi attivi fenilefrina u ketorolac.
English: The following instructions must be adhered to:
Maltese: Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -4.58 mm [95% confidence interval: -6.92, -2.24] (P < 0.001).
Maltese: Fi Studju 2, id-differenza medja peżata fit-test CMH (Omidria - plaċebo) fl-AUC medja kienet ta' -4.58 mm [intervall ta' fiduċja ta' 95%: -6.92, -2.24] (P < 0.001).
English: Pupil diameter was measured throughout the surgical procedure.
Maltese: Id-dijametru tal-pupilla tkejjel matul il-proċedura kirurġika.
English: No drug-related adverse events or pathological findings were observed, with combinations of phenylephrine and ketorolac in irrigation solution administered at concentrations up to 7200 µM phenylephrine and 900 µM ketorolac.
Maltese: Ma ġie osservat ebda avveniment avvers relatat mal-mediċina jew sejba patoloġika, b'kombinazzjonijiet ta' fenilefrina u ta' ketorolac f'soluzzjoni għall-irrigazzjoni mogħtija f'konċentrazzjonijiet sa 7200 µM ta' fenilefrina u 900 µM ta' ketorolac.
English: Clear, colourless to slightly yellow, solution with a pH: 6.3 ±0.3.
Maltese: Soluzzjoni ċara, bla kulur għal kemmxejn fl-isfar, b'pH: 6.3 ± 0.3
English: In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean area-under-the curve (AUC) was 0.58 mm [95% confidence interval: 0.48, 0.68] (P < 0.0001).
Maltese: Fi Studju 1, id-differenza medja peżata fit-test CMH (Omidria - plaċebo) fl-erja medja taħt il-kurva (AUC) kienet ta' 0.58 mm [intervall ta' fiduċja ta' 95%: 0.48, 0.68] (P < 0.0001).
English: Mydriasis was maintained in the Omidria -treated groups, while the placebo-treated groups experienced progressive constriction of the pupil (see figure).
Maltese: Il-midrijasi nżammet fil-gruppi li rċevew kura b'Omidria, filwaqt li l-gruppi li rċevew kura bi plaċebo esperjenzaw kostrizzjoni progressiva tal-pupilla (ara l-figura).
English: It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias.
Maltese: tikkawża wkoll uġigħ ta' ras, ansjetà, nawżja, u remettar, u arritmiji ventrikulari.
English: Eyelid pain
Maltese: Ż-ŻGĦAR EWLENIN
English: Excipients: citric acid monohydrate, sodium citrate dihydrate, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injection
Maltese: Eċċipjenti: aċidu ċitriku monoidrat, ċitrat tas-sodju diidrat, idrossidu tas-sodju/aċidu idrokloriku (għallaġġustament tal-pH), ilma għall-injezzjoni
English: There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using ophthalmic phenylephrine.
Maltese: Kien hemm rapporti ta' reazzjonijiet kardjovaskulari serji, inklużi arritmiji ventrikulari u infarti mijokardijaċi, f'pazjenti li kienu qed jużaw fenilefrina għall-għajnejn.
English: In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P < 0.0001).
Maltese: Fi Studju 2, iddifferenza medja peżata fit-test CMH (Omidria - plaċebo) fl-AUC medja kienet ta' 0.59 mm [intervall ta' fiduċja ta' 95%: 0.49, 0.69] (P < 0.0001).
English: In Study 2, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at cortical clean-up, and 1% of patients in the Omidria group compared to 27% of patients in the placebo group had a pupil constriction ≥ 2.5 mm (P < 0.0001, Chi-Square test).
Maltese: Fi Studju 2, 4% biss tal-pazjenti fil-grupp ta' Omidria meta mqabbla ma' 23% tal-pazjenti fil-grupp tal-plaċebo kellhom dijametru tal-pupilla ta' < 6 mm waqt it-tindif kortikali, u 1% tal-pazjenti fil-grupp ta' Omidria meta mqabbla ma' 27% tal-pazjenti fil-grupp tal-plaċebo kellhom kostrizzjoni tal-pupilla ta' ≥ 2.5 mm (P < 0.0001, test Chi-Square).
English: After dilution, chemical and physical in-use stability has been demonstrated for 6 hours at 25 ˚C.
Maltese: Wara d-dilwizzjoni, l-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 6 sigħat f'temperatura ta' 25˚C.
English: Intraocular use.
Maltese: Għal użu intraokulari.
English: Colourless 5-mL type-1 glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap.
Maltese: Kunjett ta' 5 mL tal-ħġieġ tat-tip 1 bla kulur magħluq b'tapp tal-gomma butyl u għatu tal-polypropylene tat-tip flip-off.
English: A significant reduction in ocular pain during the initial 10-12 hours postoperatively was also demonstrated.
Maltese: Intwera wkoll tnaqqis sinifikanti fl-uġigħ okulari waqt l-ewwel 10-12-il siegħa wara l-operazzjoni.
English: Sodium citrate dihydrate
Maltese: Ċitrat tas-sodrju diidrat
English: A single-dose toxicology study was conducted in African green monkeys exposed to ocular irrigation solutions containing the combination of phenylehphrine and ketorolac used during lens replacement surgery.
Maltese: Sar studju tossikoloġiku b'doża unika fuq xadini ħodor Afrikani li ġew esposti għal soluzzjonijiet okulari għall-irrigazzjoni li kien fihom il-kombinazzjoni ta' phenylehphrine u ketorolac użata waqt kirurġija ta' sostituzzjoni tal-lenti.
English: Side effects affecting the body: Common side effects: - inflammation
Maltese: Effetti sekondarji li jaffettwaw il-ġisem: Effetti sekondarji komuni: - infjammazzjoni
English: In Study 1, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at the time of cortical clean-up, and 3% of patients in the Omidria group compared to 28% of patients in the placebo group had a pupil constriction ≥2.5 mm (P < 0.0001 in both instances, Chi-Square test).
Maltese: Fi Studju 1, 4% biss tal-pazjenti fil-grupp ta' Omidria meta mqabbla ma' 23% tal-pazjenti fil-grupp tal-plaċebo kellhom dijametru tal-pupilla ta' < 6 mm waqt it-tindif kortikali, u 3% tal-pazjenti fil-grupp ta' Omidria meta mqabbla ma' 28% talpazjenti fil-grupp tal-plaċebo kellhom kostrizzjoni tal-pupilla ta' ≥ 2.5 mm (P<0.0001 fiż-żewġ każijiet, test Chi-Square).
English: Anterior chamber inflammation Conjunctival hyperaemia Corneal oedema Photophobia
Maltese: Uġigħ fl-għajnejn Infjammazzjoni talkompartiment anterjuri Iperimija konġunktivali Edema tal-kornea Fotofobija
English: Pharmacotherapeutic group: {Not yet assigned}, ATC code: {Not yet assigned}
Maltese: {Għadu mhux assenjat} Kodiċi ATC:
English: AUC change from baseline in pupil diameter (mm) during surgery (Co-primary endpoint) [Mean(SD)] Diameter < 6 mm at any time Diameter < 6 mm at cortical clean-up ≥ 2.5 mm pupillary constriction Study 2
Maltese: Dijametru < 6 mm fi kwalunkwe ħin Dijametru < 6 mm waqt it-tindif kortikali Kostrizzjoni tal-pupilla ≥ 2.5 mm Studju 2
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: After dilution in 500 mL of irrigation solution, the solution contains 0.081 mg/mL of phenylephrine and of 0.023 mg/mL ketorolac.
Maltese: Wara dilwizzjoni f'500 mL ta' soluzzjoni għall-irrigazzjoni, is-soluzzjoni jkun fiha 0.081 mg/mL ta' fenilefrina u 0.023 mg/mL ta' ketorolac.
English: Postoperative pain was evaluated by a self-administered 0-100 mm visual analogue scale (VAS).
Maltese: L-uġigħ wara l-operazzjoni ġie vvalutat permezz ta' skala analoga viżwali (VAS) fuq skala minn 0-100 mm li kienet awtoamministrata.
English: AUC 12 hour ocular pain VAS score (Co-primary endpoint) [Mean±SD]
Maltese: Bidla fl-AUC mil-linja bażi fid-dijametru tal-pupilla (mm) waqt il-kirurġija (Punt tat-tmiem ko-primarju) [Medja(SD)]
English: Omidria has not been evaluated in the the absence of standard preoperative mydriatic and anesthetic agents.
Maltese: Omidria ma ġiex ivvalutat fin-nuqqas ta' aġenti midrijatriċi u anestetiċi preoperattivi standard.
English: Pregnancy and breast-feeding
Maltese: Disturb tal-kornea Midrijasi
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 and any agreed subsequent updates of the RMP.
Maltese: AH 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: − Using aseptic technique, withdraw 4.0 mL of concentrate solution using an appropriate sterile needle.
Maltese: − Bl-użu ta' teknika asettika, iġbed 4,0 mL ta' soluzzjoni konċentrata billi tuża labra sterili xierqa.
English: In a pharmacokinetic study evaluating Omidria, systemic exposure to both phenylephrine and ketorolac was minimal and transient.
Maltese: Fi studju farmakokinetiku li vvaluta Omidria, l-esponiment sistemiku kemm għal fenilefrina kif ukoll għal ketorolac kien minimu u temporanju.
English: Subjects with VAS = 0 at all times Subjects with VAS ≥ 40 at any time
Maltese: Individwi b'VAS = 0 fi kwalunkwe ħin
English: Phenylephrine acts to keep the pupil dilated (widened).
Maltese: Fenilefrina jaġixxi biex iżomm il-pupilla dilatata (mkabbra).
English: − 4.0 mL of concentrate solution should be injected into a 500 mL bag /bottle of irrigation solution.
Maltese: − 4,0 mL ta' soluzzjoni konċentrata għandu jiġi injettat f'borża /flixkun ta' 500 mL ta' soluzzjoni għall-irrigazzjoni.
English: The use of Omidria during intraocular lens replacement surgery may cause vision to be temporarily affected.
Maltese: L-użu ta' Omidria matul kirurġija ta' sostituzzjoni tal-lenti intraokulari jista' jikkawża li l-vista tiġi affettwata temporanjament.
English: The elderly population has been studied in clinical studies.
Maltese: Il-popolazzjoni anzjana ġiet studjata fi studji kliniċi.
English: Each 4 mL of solution in the vial contains phenylephrine hydrochloride equivalent to 40.6 mg (10.2 mg/mL) of phenylephrine and ketorolac trometamol equivalent to 11.5 mg (2.88 mg/mL) of ketorolac.
Maltese: 2 mg/mL) ta' fenilefrina u ketorolac trometamol ekwivalenti għal 11.5 mg (2.88 mg/mL) ta' ketorolac.
English: After dilution, the solution contains 0.081 mg/mL phenylephrine and 0.023 mg/mL ketorolac.
Maltese: Wara d-dilwizzjoni, is-soluzzjoni jkun fiha 0.081 mg/mL ta' fenilefrina u 0.023 mg/mL ta' ketorolac.
English: The recommended dose is 4.0 mL of Omidria diluted in 500 mL of irrigation solution administered by intraocular irrigation to the affected eye during surgery.
Maltese: Id-doża rakkomandata hija ta' 4,0 mL ta' Omidria dilwit f'500 mL ta' soluzzjoni għall-irrigazzjoni li tingħata permezz ta' irrigazzjoni intraokulari lill-għajn affettwata waqt kirurġija.
English: - One of the active substances in Omidria can react with several types of anaesthetics.
Maltese: - Waħda mis-sustanzi attivi f'Omidria tista' tirreaġixxi ma' diversi tipi ta' anestetiċi.
English: E-mail: regulatory@omeros.ie
Maltese: Is-sustanzi l-oħra huma:
English: Omidria will be given to you in a hospital or clinic by a qualified doctor or surgeon who is specialised in eye surgery.
Maltese: Omidria se jingħatalek fi sptar jew fi klinika minn tabib kwalifikat jew minn kirurgu speċjalizzat filkirurġija tal-għajnejn.
English: Histologic examination in non-clinical toxicology studies demonstrated no treatment-related effects on the cornea and, in clinical trials with Omidria, no detrimental effects were observed on best-corrected visual acuity (BCVA).
Maltese: Eżami istoloġiku fi studji tossikoloġiċi mhux kliniċi ma wera l-ebda effett relatat mal-kura fuq ilkornea u, fi provi kliniċi b'Omidria, ma kien osservat l-ebda effetti detrimentali fuq l-aħjar akutezza viżiva kkoreġuta (BCVA).
English: Each 4.0 mL vial of solution contains 40.6 mg (10.2 mg/mL) of phenylephrine and 11.5 mg (2.88 mg/mL) of ketorolac.
Maltese: 2 mg/mL) ta' fenilefrina u 11.5 mg (2.88 mg/mL) ta' ketorolac.
English: Citric acid monohydrate
Maltese: Aċidu ċitriku monoidrat
English: One 4 mL vial contains phenylephrine hydrochloride equal to 40.6 mg (10.2 mg/mL) phenylephrine and ketorolac trometamol equal to 11.5 mg (2.88 mg/mL) ketorolac.
Maltese: 2 mg/mL) ta' fenilefrina u ketorolac trometamol ugwali għal 11.5 mg (2.88 mg/mL) ta' ketorolac.
English: 6.6 Special precautions for disposal and other handling To prepare Omidria for intraocular irrigation, dilute 4.0 mL of concentrate in 500 mL of standard ophthalmological irrigation solution.
Maltese: Biex tipprepara Omidria għal irrigazzjoni intraokulari, iddilwixxi 4,0 mL ta' konċentrat f'500 mL ta' soluzzjoni oftalmoloġika standard għall-irrigazzjoni.
English: Conjunctival oedema Corneal disorder Mydriasis
Maltese: .8 Effetti mhux mixtieqa
English: Omidria is indicated for addition to irrigation solution used during intraocular lens replacement procedures only.
Maltese: Din hija magħrufa bħala sostituzzjoni tal-lenti intraokulari.
English: Multipack contains 10 cartons, each carton contains one single-use vial.
Maltese: Pakkett multiplu li fih 10 kartuniet, kull kartuna fiha kunjett li jintuża darba.
English: Subjects with VAS = 0 at all times Subjects with VAS ≥ 40 at any time Study 2
Maltese: Individwi b'VAS ≥ 40 fi kwalunkwe ħin
English: Patients with narrow-angle glaucoma.
Maltese: Użu intraokulari wara d-dilwizzjoni.
English: Detectable phenylephrine plasma concentrations were observed in only one of 14 patients.
Maltese: Konċentrazzjonijiet traċċabbli ta' fenilefrina fil-plasma kienu osservati f'pazjent wieħed biss minn 14.
English: Fifty-three percent of patients had brown irides, 28% had blue irides, and 19% had irides of other colours.
Maltese: Tlieta u ħamsin fil-mija tal-pazjenti kellhom ħabba kannella, 28% kellhom ħabba blu, u 19% kellhom ħabba ta' kuluri oħra.
English: Following dilution do not store above 25 ˚C
Maltese: Wara d-dilwizzjoni taħżinx f'temperatura ogħla minn 25 ˚C
English: Colourless 5-mL type-I glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap. Each single-use vial is packaged in a cardboard carton.
Maltese: Kunjett ta' 5 mL tal-ħġieġ tat-tip I bla kulur, magħluq b'tapp tal-gomma butyl u għatu talpolypropylene tat-tip flip-off.
English: The following information is intended for healthcare professionals only: To prepare Omidria for intraocular irrigation, dilute 4.0 mL of Omidria concentrate in 500 mL of standard ophthalmological irrigation solution.
Maltese: Biex tipprepara Omidria għal irrigazzjoni intraokulari, iddilwixxi 4,0 mL ta' konċentrat ta' Omidria f'500 mL ta' soluzzjoni oftalmoloġika standard għall-irrigazzjoni.
English: Preoperative antibiotic, anaesthetics, corticosteroid, mydriatic, and NSAID eye drops may be administered at the discretion of the treating ophthalmologist.
Maltese: Fiddiskrezzjoni tal-oftalmologu kuranti, qabel il-kirurġija jistgħu jingħataw qtar tal-għajnejn antibijotiċi, anestetiċi, kortikosterojdi, midrijatriċi, u NSAIDs.
English: It may also cause headache, anxiety, nausea, vomiting, and abnormal rapid heart rhythm.
Maltese: Jista' wkoll jikkawża uġigħ ta' ras, ansjetà, nawżja, remettar, u ritmu rapidu anomalu tal-qalb.
English: This leaflet was last revised in <date of Commission Decision>
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -5.20 mm [95% confidence interval: -7.31, -3.09] (P < 0.001).
Maltese: mm [intervall ta' fiduċja ta' 95%: -7.31, -3.09] (P < 0.001).
English: Inflammation
Maltese: Infjammazzjoni
English: The phenylephrine and ketorolac in Omidria act by distinct mechanisms, to maintain intraoperative mydriasis, to prevent intraoperative miosis, and to reduce acute postoperative pain.
Maltese: Fenilefrina u ketorolac f'Omidria jaġixxu permezz ta' mekkaniżmi distinti, biex iżommu l-midrijasi intraoperattiva, biex jipprevjenul-mijosi intraoperattiva, u biex inaqqsu l-uġigħ akut wara loperazzjoni.
English: Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic medicinal products.
Maltese: Fenilefrina jista' jżid l-effett kardjovaskulari dipressanti ta' xi prodotti mediċinali anestetiċi li jittieħdu man-nifs.
English: All patients were treated with standardised preoperative topical mydriatic and anaesthetic agents.
Maltese: Il-pazjenti kollha ngħataw kura b'aġenti preoperattivi topiċi midrijatriċi u anestetiċi standardizzati.
English: Ketorolac plasma concentrations were detected in 11 of 14 patients.
Maltese: Konċentrazzjonijiet ta' ketorolac fil-plasma nstabu fi 11 minn 14-il pazjent.
English: Foreign body sensation in eyes Glare
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: Intraocular pressure increased
Maltese: Żieda fil-pressjoni intraokulari
English: No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2).
Maltese: M'huma mistennija lebda aġġustament tad-doża jew kunsiderazzjoni speċjali għal pazjenti b'indeboliment renali jew epatiku (ara sezzjoni 5.2).
English: Omidria must be administered in a controlled surgical setting by a qualified ophthalmological surgeon experienced in intraocular lens replacement surgery.
Maltese: .2 Pożoloġija u metodu ta' kif għandu jingħata Omidria għandu jingħata f'ambjent kirurġiku kkontrollat minn kirurgu oftalmologu kwalifikat b'esperjenza fil-kirurġija ta' sostituzzjoni tal-lenti intraokulari.
English: Unopened: 3 years
Maltese: Tqala u treddigħ
English: Phenylephrine is an α1-adrenergic receptor agonist and acts as a mydriatic agent by contracting the radial muscle of the iris, dilating the pupil with little or no cycloplegia.
Maltese: Fenilefrina huwa agonista tar-riċettur α1-adrenerġiku u jaġixxi bħala aġent midrijatiku billi jiġbed il-muskolu radjali tal-ħabba, u jiftaħ il-pupilla bi ftit li xejn cycloplegia.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-kartuna wara “JIS”.
English: The maximum concentration observed in this patient was 1.7 ng/mL, occurring after instillation of topical preoperative phenylephrine drops and prior to exposure to Omidria.
Maltese: Il-konċentrazzjoni massima osservata f'dan il-pazjenti kienet ta' 1.7 ng/mL, li seħħet wara linstillazzjoni ta' qtar topiku ta' fenilefrina qabel l-operazzjoni u qabel l-esponiment għal Omidria.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingћata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: The other ingredients are - Citric acid monohydrate - Sodium citrate dihydrate - Sodium hydroxide (to adjust alkalinity level) - Hydrochloric acid (to adjust acidity level) - Water for injection
Maltese: - Aċidu ċitriku monoidrat - Ċitrat tas-sodju diidrat - Idrossidu tas-sodju (biex jiġi aġġustat il-livell ta' alkalinità) - Aċidu idrokloriku (biex jiġi aġġustat il-livell ta' aċidità) - Ilma għall-injezzjoni
English: Ketorolac is a painkiller that belongs to the group called non-steroidal anti-inflammatory drugs (NSAIDS); it also helps stop the pupil from contracting (getting smaller).
Maltese: Ketorolac huwa analġesiku li jappartjeni għall-grupp imsejjaħ mediċini antinfjammatorji nonsterojdali (NSAIDS); jgħin ukoll biex iwaqqaf lill-pupilla milli tinġibed (tiċkien).
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Maltese: Omidria 10 mg/mL + 3 mg/mL konċentrat għal soluzzjoni għall-irrigazzjoni intraokulari fenilefrina/ketorolac
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation Phenylephrine/ketorolac
Maltese: Omidria 10 mg/mL + 3 mg/mL konċentrat għal soluzzjoni għall-irrigazzjoni intraokulari Fenilefrina/ketorolac
English: Package leaflet: Information for the user Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Maltese: Informazzjoni għallutent Omidria 10 mg/mL + 3 mg/mL konċentrat għal soluzzjoni għall-irrigazzjoni intraokulari fenilefrina/ketorolac
English: In the event of phenylephrine overdose, prompt injection of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine, has been recommended.
Maltese: Doża eċċessiva sistemika ta' fenilefrina tista' tikkawża żieda rapida fil-pressjoni tad-demm.
English: One 4 mL vial contains phenylephrine hydrochloride equal to 40.6 mg phenylephrine and ketorolac trometamol equal to 11.5 mg ketorolac.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett ta' 4 mL fih fenilefrina kloridrat ugwali għal 40.6 mg ta' fenilefrina u ketorolac trometamol ugwali għal 11.5 mg ta' ketorolac.
English: There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac ophthalmic solution in patients who either have a known hypersensitivity to aspirin/NSAIDs, or a past medical history of asthma.
Maltese: Kien hemm rapporti ta' bronkospażmu jew ta' taħrix tal-ażżma assoċjati mal-użu ta' soluzzjoni oftalmika ta' ketorolac f'pazjenti li jew għandhom ipersensittività magħrufa għall-aspirina/NSAIDs, jew bi storja medika filpassat ta' ażma.
English: Concomitant use of phenylephrine and atropine may enhance pressor effects and induce tachycardia in some patients.
Maltese: L-użu konkomitanti ta' fenilefrina u ta' atropina jista' jżid l-effetti ipertensivi u jinduċi takikardja f'xi pazjenti.
English: The safety and efficacy of Omidria has not been evaluated in patients with a history of uveitis, iris trauma, or alpha-adrenergic antagonist use.
Maltese: Is-sigurtà u l-effikaċja ta' Omidria ma ġewx ivvalutati f'pazjenti bi storja ta' uveite, bi trawma fl-iris, jew użu ta' antagonista ta' alpha-adrenerġiku.
English: Concentrate for solution for intraocular irrigation.
Maltese: Konċentrat għal soluzzjoni għall-irrigazzjoni intraokulari.
English: Omidria is not indicated for undiluted use, intravitreal injection, general topical ophthalmic use, or non-ocular systemic use.
Maltese: Omidria mhuwiex indikat biex jintuża mingħajr ma jiġi dilwit, għall-injezzjoni ġol-vitriju, għall-użu oftalmiku topiku ġenerali, jew għall-użu sistemiku mhux okulari.
English: Omidria must not be used:
Maltese: Omidria ma għandux jintuża: