FrancophonIA/ELRC3.0 huggingface dataset:
English: EVARREST will remain in place and adhere to the tissue, and is absorbable.
Maltese: EVARREST ser jibqa' fil-post u jeħel mat-tessut, u jiġi assorbit.
English: Contains two sealant matrices (5.1 cm x 10.2 cm) 2 units
Maltese: Qartas tal-Fojl (5,1 cm x 10,2 cm)
English: In clinical trials, the most frequently reported adverse reactions were haemorrhage and increased fibrinogen, and the most serious adverse reactions were aspiration, pulmonary embolism, and haemorrhage.
Maltese: Fi provi kliniċi, ir-reazzjonijiet avversi rapportati l-aktar kienu emorraġija u fibrinoġen żejda u rreazzjonijiet avversi l-aktar serji kienu l-ġbid tan-nifs, emboliżmu pulmonari, u emorraġija.
English: - If you get any side effects, talk to your doctor.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni.
English: For epilesional use.
Maltese: Għal użu epileżjonali.
English: The tray is in a sachet (polyester laminated aluminium foil) with a seal.
Maltese: It-trej tkun f'qartas (fojl tal-aluminju llaminat bil-poliester) b'siġill.
English: The active side is powdery in appearance.
Maltese: In-naħa attiva għandha dehra ta' trab.
English: The clot formation of EVARREST is integrated with the Matrix; it forms a mechanical barrier to bleeding and reinforces the wound site.
Maltese: Il-formazzjoni tal-għoqda tad-demm ta' EVARREST hija integrata mal-Matriċi; tifforma barriera mekkanika għat-tnixxija tad-demm u ssaħħaħ il-post tal-ferita.
English: Unintentional fluid intake into the airway (aspiration), build up of excess fluid in the cavity surrounding the lungs; the frequency was uncommon (may affect up to 1 in 100 people).
Maltese: Dħul mhux intenzjonat ta' fluwidu fil-passaġġ tan-nifs (aspirazzjoni), akkumulazzjoni ta' fluwidu żejjed fl-ispazju ta' madwar il-pulmun; il-frekwenza kienet mhux komuni (tista' taffettwa sa 1 minn kull 100 persuna).
English: In contact with physiological fluids, e.g., blood, lymph, or physiological saline, the components of the coating are activated, and the reaction of fibrinogen and thrombin initiates the last phase of physiological blood coagulation.
Maltese: F'kuntatt ma' fluwidi fiżjoloġiċi, pereż. demm, salina tal-limfa jew fiżjoloġika, il-komponenti tal-kisja jiġu attivati, u r-reazzjoni tal-fibrinoġen u t-trombina tagħti bidu għall-aħħar fażi tal-koagulazzjoni fiżjoloġika tad-demm.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Miżuri standard biex jimpedixxu infezzjonijiet li jirriżultaw minn prodotti mediċinali ppreparati minn demm jew plażma umani jinkludu l-għażla ta' donaturi, eżamijiet ta' donazzjonijiet individwali u pools tal-plażma għal markaturi speċifiċi ta' infezzjonijiet u l-inklużjoni ta' passi effikaċi ta' manifattura għall-inattivazzjoni/tneħħija ta' viruses.
English: In clinical trials of EVARREST no difference has been observed between EVARREST and control groups with regard to the incidence of thrombotic events, currently suggesting no increased risk with EVARREST use.
Maltese: Fil-provi kliniċi ta' EVARREST, ma ġiet osservata l-ebda differenza bejn il-grupp ta' EVARREST u l-grupp tal-kontroll fir-rigward tal-inċidenza ta' avvenimenti trombotiċi.
English: The safety of fibrin sealants/haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Maltese: Is-sigurtà ta' siġillanti/emostatiċi li fihom il-fibrina għall-użu fit-tqala umana jew waqt it-treddigħ ma ġietx stabbilita fi provi kliniċi kkontrollati.
English: If you experience an allergic reaction you might have one or more of the following symptoms: swelling under the skin (angioedema), skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting, or wheezing.
Maltese: Jekk inti jkollok reazzjoni allerġika jista' jkollok wieħed jew aktar mis-sintomi li ġejjin: nefħa taħt il-ġilda (anġjodema) raxx tal-ġilda, ħorriqija jew nefħiet żgħar u ħomor fil-ġilda (urtikarja), tagħfis tas-sider, sirdat, fwawar, uġigħ ta' ras, pressjoni tad-demm baxxa, għeja kbira, dardir, irrikwitezza, qalb tħabbat aktar mgħaġġel, tnemnim, rimettar jew tħarħir.
English: Bottle (HDPE)
Maltese: Perjodu ta' Tiżmim flixkun (HDPE)
English: EU (MA) Number Invented Name
Maltese: Numru ta' l-EU
English: Dog and cats Dogs: intravenous or subcutaneous Cats: subcutaneous
Maltese: Speċi li fuqhom għandu jintuża l-prodott
English: 1.5 g 100 sachets
Maltese: Isem kummer ċjali
English: 1.5 g 20 sachets Meat and offal: 3 days
Maltese: Ħalib: 5 ijiem (Baqar)
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/123)
Maltese: Riżultat ta' proċedura skont l-Artikolu 34 tad-Direttiva 2001/82/KE (EMEA/V/A/123)
English: What is Lincocin?
Maltese: X'inhu Lincocin?
English: Lincomycin is a lincosamide antibiotic which is produced by Streptomyces lincolnensis.
Maltese: Il-linkomiċina hija antibijotiku linkosamid prodott minn Streptomyces lincolnensis.
English: Lincocin (and associated names, such as Lincocine poudre soluble and Albiotic Pulver 400 mg/g) is marketed in Belgium, Denmark, France, Germany, Hungary, Ireland, Poland and United Kingdom.
Maltese: Lincocin (u l-ismijiet assoċjati, bħal Lincocine poudre soluble u Albiotic Pulver 400 mg/g) jitqiegħed fissuq fil-Belġju, fid-Danimarka, fi Franza, fil-Ġermanja, fl-Ungerija, fl-Irlanda, fil-Polonja u fir-Renju Unit.
English: Lincocin is a veterinary medicinal product available as powder for oral solution and contains 400 mg lincomycin per gram of product.
Maltese: Lincocin huwa prodott mediċinali veterinarju li jiġi bħala trab għal soluzzjoni orali u fih 400 mg linkomiċina għal kull gramma tal-prodott.
English: Lincocin is indicated for the treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae in pigs and treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens in chickens.
Maltese: Lincocin huwa indikat għall-kura u l-metafilassi ta' pulmonite enzootika kkawżata minn Mycoplasma hyopneumoniae fil-ħnieżer u għall-kura u l-metafilassi ta' enterite nekrotika kkawżata minn Clostridium perfringens fit-tiġieġ.
English: Questions and answers on Lincocin and its associated names EMA/585749/2017
Maltese: 5 ta' Ottubru 2017 EMA/585749/2017
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for Lincocin in the European Union (EU).
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni dwar il-prodott [sommarju tal-karatteristiċi tal-prodott (SPC, summary of product characteristics), tat-tikkettar u tal-fuljett ta' tagħrif] għal Lincocin fl-Unjoni Ewropea (UE).
English: Lincocin is authorised in the EU via national procedures.
Maltese: Lincocin huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: On 5 July 2016, the European Commission referred the matter to the CVMP in order to harmonise the product information for Lincocin (and associated names) in the EU.
Maltese: Fil-5 ta' Lulju 2016, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CVMP sabiex jarmonizza linformazzjoni dwar il-prodott għal Lincocin (u l-ismijiet assoċjati) fl-UE.
English: On 13 July 2017, the European Medicines Agency (the Agency) completed a review of Lincocin.
Maltese: Fit-13 ta' Lulju 2017, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet rieżami ta' Lincocin.
English: The European Commission issued a decision on 5 October 2017.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fil-5 ta' Ottubru 2017.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Lincocin and its associated names should be harmonised across the EU.
Maltese: Abbażi tal-valutazzjoni tad-data disponibbli bħalissa, is-CVMP ikkonkluda li l-informazzjoni dwar ilprodott għal Lincocin u l-ismijiet assoċjati tiegħu għandha tiġi armonizzata fl-UE kollha.
English: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Spain
Maltese: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Spanja
English: In vitro studies have shown that olopatadine did not inhibit metabolic reactions which involve cytochrome P-450 isozymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Maltese: Studji in vitro wrew li olopatadine ma waqqafx reazzjonijiet metaboliċi li jinvolvu l-iżożimi taċċitokromju P-450, 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A4.
English: Opatanol contains Benzalkonium chloride
Maltese: OPATANOL fih Benzalkonium chloride
English: Date of first authorisation: 17 May 2002 Date of latest renewal: 22 May 2007
Maltese: Data tal-aħħar tiġdid: 22 ta' Mejju 2007.
English: Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, hydrochloric acid/sodium hydroxide and purified water.
Maltese: Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, hydrochloric acid/sodium hydroxide, ilma pur.
English: The following adverse reactions have been reported during clinical studies and post-marketing data and 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 <1/1000)very rare (<1/10,000) or not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati waqt studji kliniċi u minn dejta ta' wara t-tqegħid fis-suq u huma kklassifikati skont il-konvenzjoni li ġejja: komuni ħafna(≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1000 sa <1/100), rari (≥1/10,000 sa <1/1000) rari ħafna (<1/10,000) jew mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: What Opatanol contains - The active substance is olopatadine.
Maltese: X'fih OPATANOL - Is-sustanza attiva hi olopatadine.
English: Alcon Cusí, S.A. Camil Fabra 58 08320 El Masnou Barcelona Spain
Maltese: Alcon Cusí, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spanja.
English: (picture 2).
Maltese: (stampa 1)
English: Benzalkonium chloride sodium chloride disodium phosphate dodecahydrate (E339) hydrochloric acid (E507) (to adjust pH) sodium hydroxide (E524) (to adjust pH) purified water
Maltese: Benzalkonium chloride sodium chloride disodium phosphate dodecahydrate (E339) hydochloric acid (E507) (għall-aġġustament tal-pH) sodium hydroxide(E524) (għall-aġġustament tal-pH) ilma pur
English: Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Maltese: Benzalkonium chloride ġie rrapurtat ukoll li jikkawża punctate keratopathy u/jew ulċera tossika keratopatika.
English: Uncommon corneal erosion, corneal epithelium defect, corneal epithelium disorder, punctate keratitis, keratitis, corneal staining, eye discharge, photophobia, vision blurred, visual acuity reduced, blepharospasm, ocular discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, lacrimation increased, erythema of eyelid, eyelid oedema, eyelid disorder, ocular hyperaemia
Maltese: Mhux komuni taħfir tal-kornea, diffett fl-epitilju talkornea, disturb fl-epitilju tal-kornea, keratite ttikkjata, keratite, tbajja filkornea, tnixxija mill-għajn, fotofobija, vista mċajpra, tnaqqis fl-akutezza talvista, blefarospażmu, skumdita flgħajnejn, ħakk fl-għajnejn, follikuli fil-konġuntiva, disturb fil-konġuntiva, sensazzjoni ta' xi ħaġa barranija flgħajnejn, żieda fid-dmugħ, eritema filkappell tal-għajn, edima fil-kappell talgħajn, disturb fil-kappell tal-għajn, iperimija fl-għajnejn.
English: Opened (1):
Maltese: Miftuħ (1):
English: The most frequent treatment-related adverse reaction was eye pain, reported at an overall incidence of 0.7%.
Maltese: L-aktar reazzjoni avversa frekwenti relatata ma' trattament kienet uġigħ fl-għajnejn, b'inċidenza totali ta' 0.7%.
English: BOX OF 1 BOTTLE + BOX OF 3 BOTTLES
Maltese: KAXXA TA' FLIXKUN WIEĦED + KAXXA TA' 3 FLIEXKEN
English: Opened (3):
Maltese: Miftuħ (3):
English: Approximately 60-70% of the dose was recovered in the urine as active substance.
Maltese: Madwar 60-70% tad-doża nstabet fl-awrina bħala sustanza attiva.
English: Approximately 4.5% of patients can be expected to experience adverse reactions associated with the use of Opatanol; however, only 1.6% of patients discontinued from the clinical studies due to these adverse reactions.
Maltese: Huwa mistenni li bejn wieħed u ieħor 4.5% tal-pazjenti jkollhom reazzjonijiet avversi, assoċjati ma' lużu ta' OPATANOL; madanakollu, 1.6% biss ta' dawn il-pazjenti waqqfu mill-istudji kliniċi minħabba reazzjonijiet avversi.
English: Studies comparing the pharmacokinetics of 10 mg oral doses of olopatadine in young (mean age 21 years) and elderly (mean age 74 years) showed no significant differences in the plasma concentrations (AUC), protein binding or urinary excretion of unchanged parent drug and metabolites.
Maltese: Studji li fihom tqabblu il-farmakokinetiċi ta' meta 10 mg ta'olopatadine jingħata mill-ħalq f'żagħżagħ (eta' medja ta' 21 sena) u anzjani (eta' medja ta' 74 sena) urew li ma kienx hemm differenza sinifikanti. fil-konċentrazzjonijiet fil-plażma (AUC), fl-ammont li jintrabat mal-proteina jew li joħroġ fl-awrina bħala sustanza mhux mibdula kif tinsab fil-mediċina u l-metaboli.
English: Opatanol 1 mg/mL eye drops olopatadine
Maltese: OPATANOL 1 mg/mL qtar għall-għajnejn olopatadine
English: - The other ingredients are benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), hydrochloric acid (E507) and/or sodium hydroxide (E524) and purified water.
Maltese: - Is-sustanzi mhux attivi l-oħra huma benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), hydrochloric acid (E507) u/jew sodium hydroxide (E524) u ilma purifikat.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http:/www.ema.europa.eu
English: If you are using other eye drops or eye ointment medicines, leave at least 5 minutes between each medicine.
Maltese: Jekk qed tuża mediċini oħra f'għamla ta' qtar għall-għajnejn jew ingwent għall-għajnejn, ħalli millinqas 5 minuti bejn kull mediċina.
English: System Organ Classification
Maltese: Klassifika tas-Sistemi u talOrgani
English: Available data in animals have shown excretion of olopatadine in milk following oral administration (for details see section 5.3).
Maltese: Dejta disponibbli fl-annimali uriet li kien hemm eliminazzjoni ta' olopatadine fil-ħalib tas-sider wara għoti orali (gћad-dettalji ara sezzjoni 5.3).
English: Manufacturer S.A. Alcon-Couvreur N.V. Rijksweg 14
Maltese: Il-Manifattur S.A. Alcon-Couvreur N.V.
English: Opatanol 1 mg/mL eye drops, solution olopatadine
Maltese: OPATANOL 1 mg/mL qtar għall-għajnejn, soluzzjoni olopatadine
English: The range of peak steady-state olopatadine plasma concentrations (35 to 127 ng/ml) seen in this study represents at least a 70-fold safety margin for topical olopatadine with respect to effects on cardiac repolarisation.
Maltese: L-ogħla livelli ta' olopatadine fiss fil-plasma (35 sa 127 ng/ml) li ntlaħqu waqt dan l-istudju jisarrfu f'70 darba il-marġini ta' sigurta fir-rigward tal-effetti fuq ir-ripolarizazzjoni talqalb.
English: Since olopatadine is excreted in urine primarily as unchanged active substance, impairment of renal function alters the pharmacokinetics of olopatadine with peak plasma concentrations 2.3-fold greater in patients with severe renal impairment (mean creatinine clearance of 13.0 ml/min) compared to healthy adults.
Maltese: Billi l-parti l-kbira ta' olopatadine joħroġ fl-awrina mingħajr ma jinbidel bħala sustanza attiva, ilkaratteristiċi farmakokinetiċi tiegħu jinbidlu f'pazjenti li għandhom indeboliment tal-kliewi u jispiċċaw b'livelli fil-plasma 2.3-darba ogħla meta jkollhom indeboliment serju tal-kliewi (mean creatinine clearance ta' 13.0 ml/min) meta mqabbla ma' adulti b'saħħithom.
English: Two metabolites, the mono-desmethyl and the Noxide, were detected at low concentrations in the urine.
Maltese: Traċċi ta' żewġ metabolimono-desmethyl u l-N-oxide, instabu fl-awrina.
English: However, systemic absorption of topically applied olopatadine is minimal with plasma concentrations ranging from below the assay quantitation limit (<0.5 ng/ml) up to 1.3 ng/ml.
Maltese: Madanakollu, meta jintuża b'mod topiku, l-ammont li jiġi assorbit b'mod sistemiku huwa minimu b'livelli fil-plażma li ma jilħqux l-inqas livell li jista jiġi mkejjel- (<0.5 ng/ml) sa 1.3 ng/ml.
English: 5 ml opaque low density polyethylene bottles with polypropylene screw caps (DROP-TAINER).
Maltese: Flixken tal-plastik opaki ta' 5 ml magħmula minn polyethylene ta' densita' baxxa, u b'tapp tal-kamin magħmul minn polypropylene (BIL-QATTARA).
English: How to store Opatanol
Maltese: Mediċini oħra u OPATANOL
English: 1 mL of solution contains 1 mg olopatadine (as hydrochloride).
Maltese: 1 mL ta' soluzzjoni fih 1 mg olopatadine (bħala hydrochloride).
English: Posology
Maltese: DETENTURI
English: A 5 mg oral dose was administered twice-daily for 2.5 days to 102 young and elderly male and female healthy volunteers with no significant prolongation of QTc interval compared to placebo.
Maltese: Meta ngħatat doża ta' 5 mg darbtejn kuljum għal 2.5 ġranet lil 102 voluntiera nisa u rġiel f'saħħithom żgħar u anzjani, ma kienx hemm differenza sinifikanti fit-tul ta' l-interval QTc meta mqabbel ma dawk li ngħataw plaċebo.
English: Blurred, reduced, or abnormal vision, corneal disorder, eye surface inflammation with or without surface damage, inflammation or infection of the conjunctiva, eye discharge, sensitivity to light, increased tear production, itchy eye, redness of the eye, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid.
Maltese: Vista mċajpra, mnaqqsa jew mhux normali, disturbi fil-korneja, infjammazzjoni tas-superfiċje talgħajn flimkien ma jew mingħajr ħsara fis-superfiċje, infjammazzjoni jew infezzjoni tal-konġuntiva, tnixxija ta' l-għajn, allerġija ta' l-għajn, sensittività għad-dawl, żieda fid-dmugħ, ħakk fl-għajn, hmura fl-għajn, il-kappell tal-għajn mhux normali; ħakk, ħmura, nefħa, jew qxur fuq il-kappell tal-għajn.
English: Uncommon rhinitis
Maltese: TAGĦRIF
English: Benzalkonium is known to discolour soft contact lenses.
Maltese: Benzalkonium huwa magħruf li jbiddel il-kulur ta' lentijiet tal-kuntatt rotob.
English: Not known hypersensitivity, swelling face
Maltese: Mhux magħrufa sensittività eċċessiva, nefħa fil-wiċċ
English: In clinical studies involving 1680 patients, Opatanol was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg.
Maltese: Fi studji kliniċi li fihom ħadu sehem bejn wieħed u ieħor 1680 pazjent, OPATANOL ingħata minn darba sa' erba' darbiet kuljum fiż-żewġ għajnejn għal erba' xhur waħdu jew ma' 10 mg loratadine.
English: 1 x 5 mL 3 x 5 mL
Maltese: Qtar għall-għajnejn, soluzzjoni 1 x 5 mL
English: The preservative in Opatanol, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Maltese: Il-preservattiv f'Opatanol, benzalkonium chloride, jista' jigi assorbit mil-lentijiet tal-kuntatt rotob u jista ibiddel il-kulur tal-lentijiet tal-kuntatt.
English: Use in hepatic and renal impairment
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni rinite
English: Not known (frequency cannot be estimated from the available data) Effects in the eye
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli) Effetti fl-għajn
English: These results indicate that olopatadine is unlikely to result in metabolic interactions with other concomitantly administered active substances.
Maltese: B'hekk jidher li olopatadine mhux probabbli li jkollu interazzjonijiet metaboliċi ma' sustanzi attivi oħra li jingħataw miegħu
English: One mL of solution contains 1 mg olopatadine (as hydrochloride).
Maltese: Kull mL ta' soluzzjoni fih 1mg of olopatadine (bħala hydrochloride).
English: Common (may affect up to 1 in 10 people) Effects in the eye:
Maltese: Komuni(jistgħu jaffetwaw sa persuna waħda minn kull 10) Effetti fl-għajn:
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni ma prodotti mediċinali oħra.
English: Do not use Opatanol
Maltese: Tużax OPATANOL
English: This medicine contains 0.5 mg benzalkonium chloride in each 5 ml which is equivalent to 0.1 mg/ml.
Maltese: Din il-mediċina fiha 0.1 mg ta' benzalkonium chloride f'kull ml li hu ekwivalenti għal 0.1 mg/ml.
English: Not known dermatitis, erythema
Maltese: Mhux magħrufa dermatite, eritema
English: Opatanol contains benzalkonium chloride which may cause eye irritation.
Maltese: OPATANOL fih benzalkonium chloride li jista' jikkawża irritazzjoni fl-għajnejn.
English: What Opatanol looks like and contents of the pack Opatanol is a clear and colourless liquid (a solution) supplied in a pack containing either one 5 ml bottle or three 5 ml plastic bottles with screw caps.
Maltese: Kif jidher OPATANOL u l-kontenut tal-pakkett OPATANOL huwa likwidu ċar u bla kulur (soluzzjoni) li jiġi f'pakkett li fih flixkun wieħed ta' 5 ml jew tliet flixken tal-plastik, kollha b'tapp tal-kamin.
English: Pharmacotherapeutic group: ophthalmologicals; decongestant and antiallergics; other antiallergics, ATC code: S01GX 09
Maltese: Kategorija farmakoterapewtika: oftalmoloġiċi, sustanzi li jiftħu l-imnieħer misdud u li jaħdmu kontra l-allerġiji, antiallerġiċi oħra.
English: The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (8 hourly).
Maltese: Id-doża hija ta' qatra waħda ta' OPATANOL fil-borża tal-konġuntiva ta' l-għajn(ejn) affettwata(i) darbtejn kuljum (kull 8 sigħat).
English: Olopatadine is a potent selective antiallergic/antihistaminic agent that exerts its effects through multiple distinct mechanisms of action.
Maltese: Olopatadine hu sustanza qawwija u selettiva kontra l-allerġiji u kontra l-istamina li jaħdem permezz ta' ħafna proċessi distinti.
English: • If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku (tbati minn sensittività eċċessiva) għal olopatadine jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Uncommon dermatitis contact, skin burning sensation, dry skin
Maltese: Mhux komuni dermatite tal-kuntatt, sensazzjoni ta' ħruq fil-ġilda, ġilda xotta
English: • Gently press on the base of the bottle to release one drop of Opatanol at a time.
Maltese: • Imbotta bil-ġentilezza il-qih tal-flixkun biex tqattar OPATANOL taqtira taqtira.
English: Not known corneal oedema, eye oedema, eye swelling, conjunctivitis, mydriasis, visual disturbance, eyelid margin crusting
Maltese: F'kull sezzjoni ta' frekwenza, ir-reazzjonijiet avversi huma mniżżla skont is-serjetà tagħhom bl-aktar serji jitniżżlu lewwel.
English: Shortness of breath, increased allergic symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinus infection, skin redness and itching.
Maltese: Sensazzjoni mnaqqsa jew mhux normali, sturdament, tnixxija mill-imnieħer, ġilda xotta, infjammazzjoni tal-ġilda.
English: It antagonises histamine (the primary mediator of allergic response in humans) and prevents histamine induced inflammatory cytokine production by human conjunctival epithelial cells.
Maltese: Minn tagħrif ta' studji in vitro jidher li jista' jaħdem fuq iċ-ċelluli mast tal-konġuntiva umana biex jinibixxi sustanzi pro-infjammatorji.
English: This exposure would result in a final dose of 0.5 mg/kg in a 10 kg infant, assuming 100% absorption.
Maltese: Dan l-ammont jissarraf f'doża ta' 0.5 mg/kg f'tarbija ta' 10 kg jekk nassumu li jiġi assorbit 100%.