FrancophonIA/ELRC3.0 huggingface dataset:
English: Local reactions, in the form of soft/hard swelling (below or equal to 0.7 cm diameter) without heat or pain, were very commonly observed at the injection site and resolved within 5 days.
Maltese: Reazzjonijiet lokali f'forma ta' nefħiet rotob/ibsin (anqas jew daqs 0.7 cm fid-dijametru) mingħajr sħana jew uġigħ kienu komuni ħafna fil-post tal-injezzjoni u marru fi żmien 5 ijiem.
English: The solvent may be stored outside a refrigerator at 15 °C - 25 °C.
Maltese: Is-solvent jista' jinżamm barra mill-friġġ f'temperatura ta' 15 °C - 25 °C.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Intramuscular injection: 2 ml in the neck.
Maltese: U METODU TA' AMMINISTRAZZJONI Injezzjoni fil-muskolu: 2 ml fl-għonq.
English: Lactation:
Maltese: Lijofiliżat:
English: Cardboard box of 1 vial of 15 ml (50 doses) and 1 vial of 100 ml of solvent.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' 15 ml (50 doża) u kunjett wieħed b'100 ml solvent.
English: Mass vaccination can be used in herds in which the prevalence of European PRRS virus has been established.
Maltese: Tilqim tal-massa jista' jingħata f'merħliet fejn ġiet stabbilita l-prevalenza tal-virus PRRS Ewropew.
English: The area of local tissue reaction is in general below 1.4 cm in diameter.
Maltese: B'mod ġenerali ż-żona tar-reazzjoni lokali tat-tessuti hija anqas minn 1.4 cm fid-dijametru.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Ara sezzjoni 6.3 għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit.
English: Cardboard box of 1 vial of 15 ml (25 doses) and 1 vial of 50 ml of solvent.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' 15 ml (25 doża) u kunjett wieħed b'50 ml solvent.
English: Local reactions in the form of swellings are very common and resolve spontaneously within 32 days.
Maltese: Reazzjonijiet lokali f'forma ta' nefħiet huma komuni ħafna u jgħaddu waħedhom fi żmien 32 jum.
English: The maximum size of the local reactions was bigger (2 cm) and the maximum duration was in general longer (up to 9 days in pre-breeding sows).
Maltese: Id-daqs massimu tarreazzjonijiet lokali kien akbar (2 cm) u b'mod ġenerali t-tul ta' żmien massimu kien itwal (sa 9 ijiem f'majjaliet qabel it-tgħammir).
English: The area of local tissue reaction is in general below 0.5 cm in diameter.
Maltese: B'mod ġenerali ż-żona tar-reazzjoni lokali tat-tessuti hija anqas minn 0.5 cm fid-dijametru.
English: Lyophilisate and solvent for suspension for injection
Maltese: Lijofiliżat u solvent għal sospensjoni għall-injezzjoni
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials (15 ml, containing 25, 50 or 125 doses)
Maltese: Kunjetti tal-ħġieġ (15 ml, li fihom 25, 50 jew 125 doża)
English: A local reaction involving transiently the whole neck region was very commonly observed (red-purple dark, erythematous swelling, causing itching, vesicle formation, increased local temperature, and, occasionally, pain).
Maltese: Kienet osservata komuni ħafna reazzjoni lokali li tgħaddi fiż-żona kollha tal-għonq (skur aħmar filvjola, nefħa eritematoża, li tikkawża ħakk, formazzjoni ta' fosos u żieda tat-temperatura lokali, u, xi kultant, uġigħ).
English: The area of local tissue reaction is in general below 5 cm in diameter.
Maltese: B'mod ġenerali ż-żona tar-reazzjoni lokali tattessuti hija anqas minn 5 cm fid-dijametru.
English: PACKAGE LEAFLET: Suvaxyn PRRS MLV lyophilisate and solvent for suspension for injection for pigs
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza murija fuq il-pakkett u fuq ilkunjett wara
English: Suvaxyn PRRS MLV solvent for suspension for injection for pigs
Maltese: VETERINARJU Suvaxyn PRRS MLV solvent għal sospensjoni għall-injezzjoni għall-ħnieżer
English: The area of local tissue reaction is in general below 2 cm in diameter.
Maltese: B'mod ġenerali ż-żona tar-reazzjoni lokali tat-tessuti hija anqas minn 2 cm fid-dijametru.
English: Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and ensure complete reconstitution.
Maltese: Ittrasferixxi bejn wieħed u ieħor 5 ml tas-solvent għal ġol-kunjett li fih il-lijofiliżat u kun żgur li r-rikostituzzjoni hija kompluta.
English: Suvaxyn PRRS MLV lyophilisate and solvent for suspension for injection for pigs
Maltese: GĦAMLA FARMAĊEWTIKA Solvent għal sospensjoni għall-injezzjoni
English: Suvaxyn PRRS MLV lyophilisate for suspension for injection for pigs
Maltese: VETERINARJU Suvaxyn PRRS MLV lijofiliżat għal sospensjoni għall-injezzjoni għall-ħnieżer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (25, 50 and 125 doses)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun (25, 50 u 125 doża)
English: Duration of immunity: 26 weeks after vaccination.
Maltese: Perjodu tal-immunità: 26 ġimgħa wara t-tilqima.
English: A single booster dose is given every 6 months.
Maltese: Doża booster waħda tingħata kull 6 xhur.
English: The reaction evolved to form hard tissue and formation of a scab, which very commonly lasted up to more than 44 days.
Maltese: Ir-reazzjoni evolviet biex iffurmat tessut iebes u formazzjoni ta' qoxra li komuni ħafna damet sa aktar minn 44 jum.
English: 12 January 2015
Maltese: 12 ta' Jannar 2015
English: November 2014 CMDh meeting
Maltese: Laqgħa tas-CMDh Novembru 2014
English: Implementation of the agreement by the Member States (submission of the variation to implement the changes to the product information by the Marketing Authorisation Holder):
Maltese: Implimentazzjoni tal-ftehim mill-Istati Membri (sottomissjoni tal-varjazzjoni biex jiġu implimentanti l-bidliet fl-informazzjoni dwar ilprodott mid-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq):
English: 16 December 2014
Maltese: 16 ta' Diċembru 2014
English: The educational materials should be submitted at the same time as the variation of product information application.
Maltese: Il-materjal edukattiv għandu jiġi sottomess flimkien mal-varjazzjoni tal-applikazzjoni għallinformazzjoni dwar il-prodott.
English: It may harm them,
Maltese: skumdità okulari,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1400/001
Maltese: EU/1/19/1400/001
English: Day 90
Maltese: Jum 90
English: Day 15
Maltese: Jum 15
English: Netarsudil 0.02% Once daily
Maltese: Netarsudil 0.02 % Darba kuljum
English: Timolol 0.5% twice daily Difference (95% CI) Netarsudil - Timolol
Maltese: Differenza (95 % CI) Netarsudil - Timolol
English: Day 43
Maltese: Jum 43
English: INFORMATION IN BRAILLE Rhokiinsa
Maltese: INFORMAZZJONI BIL-BRAILLE Rhokiinsa
English: Benzalkonium chloride, boric acid, mannitol, sodium hydroxide, water for injections.
Maltese: Benzalkonium chloride, boric acid, mannitol, sodium hydroxide, ilma għall-injezzjonijiet.
English: Benzalkonium chloride
Maltese: Benzalkonium chloride Mannitol
English: The primary efficacy outcome measure was mean IOP at each of 9 timepoints measured at 08:00, 10:00 and 16:00 on day 15, day 43 and day 90.
Maltese: Il-kejl ta' eżitu tal-effikaċja primarja kien ifisser IOP medju f'kull wieħed minn 9 punti ta' żmien imkejla fi 08:00, 10:00 u 16:00 f'jum 15, jum 43 u jum 90.
English: Carton containing 1 bottle.
Maltese: Kartuna li fiha flixkun 1.
English: Clear solution, pH 5 (approximately).
Maltese: Soluzzjoni ċara, pH 5 (bejn wieħed u ieħor).
English: Each ml of solution contains 150 micrograms benzalkonium chloride.
Maltese: Kull ml tas-soluzzjoni fih 150 mikrogramma benzalkonium chloride.
English: Reactions are classified according to the 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 the available data).
Maltese: Ir-reazzjonijiet huma kklassifikati skont il-konvenzjoni: 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: System Organ Classification
Maltese: Sistema tal-Klassifika tal-Organi
English: - The other excipients are benzalkonium chloride (see section 2 under ‘Rhokiinsa contains benzalkonium chloride'), mannitol, boric acid, sodium hydroxide and water for injections.
Maltese: L-eċċipjenti l-oħra huma benzalkonium chloride (ara s-sezzjoni 2 taħt “Rhokiinsa fih benzalkonium chloride”), mannitol, boric acid, sodium hydroxide u ilma għall-injezzjonijiet.
English: Discontinuation rates due to adverse reactions were 19.3% for the netarsudil treatment group versus 1.7% for the timolol maleate group.
Maltese: Ir-rati ta' waqfien minħabba reazzjonijiet avversi kienu 19.3 % għall-grupp ta' trattament ta' netarsudil kontra 1.7 % għall-grupp ta' timolol maleate.
English: Marketing Authorisation Holder and Manufacturer Aerie Pharmaceuticals Ireland, Limited Athlone Business and Technology Park, Dublin Road,
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Aerie Pharmaceuticals Ireland, Limited Athlone Business and Technology Park, Dublin Road,
English: The following side effects have been observed with Rhokiinsa:
Maltese: Ġew osservati l-effetti sekondarji li ġejjin b'Rhokiinsa:
English: Cornea Verticillata
Maltese: Kornea Vertikillata
English: Over half were aged ≥ 65 years.
Maltese: Aktar minn nofs kellhom ≥ 65 sena.
English: Unopened bottles: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: Intravenous administration of netarsudil mesylate to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures.
Maltese: L-għoti ġol-vini ta' netarsudil mesylate lil firien u fniek tqal matul l-organoġeneżi ma pproduċiex effetti embrijofetali avversi f'esponimenti sistemiċi klinikament relevanti.
English: The most frequently reported adverse reactions associated with discontinuation in the Rhokiinsa groups were conjunctival hyperemia (5.8%), cornea verticillata (3.7%) and vision blurred (1.4%).
Maltese: Ir-reazzjonijiet avversi l-aktar irrapportati ta' spiss assoċjati mat-twaqqif fil gruppi ta' Rhokiinsa kienu iperemija konġuntivali (5.8 %), kornea vertikillata (3.7 %) u vista mċajpra (1.4 %).
English: Uncommon hypersensitivity
Maltese: Mhux komuni sensittività eċċessiva
English: There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/ml) post dose on day 1 and day 8.
Maltese: netarsudil (limitu aktar baxx ta' kwantifikazzjoni (LLOQ) 0.100 ng/ml) wara d-doża f'jum 1 u jum 8.
English: Ocular effects
Maltese: Effetti okulari
English: Do not swallow or inject.
Maltese: opaċitajiet lentikulari, konġuntivite noninfettiva,
English: Conjunctival hyperaemia was typically mild in severity and sporadic.
Maltese: L-iperemija konġuntivali kienet tipikament ħafifa fis-severità u sporadika.
English: Sodium hydroxide (for pH-adjustment) Water for injections
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)
English: With the exception of the incidence of cornea verticillata, no other difference in safety profile was observed between races or age groups (see section 4.8).
Maltese: Bl-eċċezzjoni tal-inċidenza ta' kornea vertikillata, ma ġiet osservata l-ebda differenza oħra fil-profil tas-sigurtà bejn ir-razez jew il-gruppi ta' età (ara sezzjoni 4.8).
English: Other ocular adverse reactions reported are: cornea verticillata (17%), instillation site pain (17%), and conjunctival haemorrhage (8%).
Maltese: Reazzjonijiet avversi okulari oħra li ġew irrapportati huma: kornea vertikillata (17 %), uġigħ fis-sit tal-instillazzjoni (17 %), u emorraġija konġuntivali (8 %).
English: Netarsudil and its active metabolite AR-13503 was found to have a possible phototoxic potential in a modified 3T3 NRU-PT in vitro assay, where the wavelength was extended to include UVB light.
Maltese: Netarsudil u l-metabolit attiv tiegħu AR-13503 instab li għandhom potenzjal fototossiku possibbli f'assaġġ in vitro modifikat 3T3 NRU-PT fejn it-tul tal-mewġa ġie estiż biex jinkludi d-dawl UVB.
English: Baseline
Maltese: rinalġija
English: • General side effects: Headache
Maltese: • Effetti sekondarji oħra: Uġigħ ta' ras
English: The most common ocular adverse reaction observed is conjunctival hyperemia which was reported in 51% of patients.
Maltese: Ir-reazzjoni avversa okulari l-aktar komuni osservata hija iperemija konġuntivali li ġiet irrapportata f'51 % tal-pazjenti.
English: Benzalkonium chloride content
Maltese: Kontenut ta' benzalkonium chloride
English: Rhokiinsa contains benzalkonium chloride This medicine contains approximately 150 micrograms benzalkonium chloride in each ml of solution.
Maltese: Rhokiinsa fih benzalkonium chloride Din il-mediċina fiha madwar 150 mikrogramma benzalkonium chloride f'kull ml ta' soluzzjoni.
English: Instillation site erythema (8%), corneal staining (7%), blurred vision (6%), increased lacrimation (6%) and erythema of eyelid (5%) were also reported.
Maltese: Ġew irrapportati wkoll eritema fis-sit tal-instillazzjoni (8 %), tbajja' tal-kornea (7 %), vista mċajpra (6 %), żieda fid-dmugħ (6 %) u eritema tal-kappell tal-għajn (5 %).
English: The median age of study participants was 65.5 years (range 18 to 91 years).
Maltese: L-età medjana tal-parteċipanti fl-istudju kienet ta' 65.5 snin (medda 18-il sena sa 91 sena).
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: For ocular use.
Maltese: Użu okulari.
English: Rhokiinsa 200 micrograms/ml eye drops, solution netarsudil
Maltese: Rhokiinsa 200 mikrogramma/ml qtar tal-għajnejn, soluzzjoni netarsudil
English: However, there was a relatively small proportion of subjects with moderate or severe hyperaemia who discontinued treatment because of this adverse reaction (6.0% in Phase 3 clinical studies).
Maltese: Madankollu, kien hemm proporzjon relattivament żgħir ta' individwi b'iperemija moderata jew severa li ma komplewx it-trattament minħabba din ir-reazzjoni avversa (6.0 % fi studji kliniċi talFażi 3).
English: Efficacy was also investigated in patients with baseline IOP ≥25 mmHg and <30 mmHg.
Maltese: L-effikaċja ġiet investigata wkoll f'pazjenti b'linja bażi tal-IOP ≥ 25 mmHg u < 30 mmHg.
English: What Rhokiinsa contains - The active substance is netarsudil.
Maltese: Is-sustanza attiva hi netarsudil.
English: With the exception of cornea verticillata (see above), no difference in the safety profile for Rhokiinsa has been observed between subjects aged <65 or ≥65 years.
Maltese: Bl-eċċezzjoni tal-kornea vertikillata (ara hawn fuq), ma ġiet osservata l-ebda differenza fil-profil tassigurtà għal Rhokiinsa bejn l-individwi li għandhom <65 jew ≥65 sena.
English: The non-inferiority margin applied was a difference in mean IOP ≤1.5 mmHg for all time points over all visits through 3 months and ≤1.0 mmHg at a majority of these time points.
Maltese: Il-marġni ta' nuqqas ta' inferjorità applikat kien differenza fl-IOP medju ≤ 1.5 mmHg għall-punti ta' żmien kollha matul iż-żjarat kollha sa 3 xhur u ≤1.0 mmHg b'maġġoranza ta' dawn il-punti ta' żmien.
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: In pregnant rats, 0.3 mg/kg/day (1000 times the recommended ophthalmic dose) and higher showed increased postimplantation loss and reduced foetal viability.
Maltese: F'firien tqal, 0.3 mg/kg/jum (1000 darba tad-doża oftalmika rakkomandata) u ogħla wriet żieda fit-telf ta' wara l-impjant u tnaqqis fil-vijabbiltà fetali.
English: Table 1: Mean IOP by visit: PP population with baseline IOP <25 mmHg Study Visit and Time Point
Maltese: Tabella 1: IOP medju skont iż-żjara: Popolazzjoni PP b'linja bażi tal-IOP < 25 mmHg Żjara ta' Studju u Punt ta' Żmien
English: Netarsudil demonstrated clinically relevant reductions in IOP at all timepoints, however non-inferiority to timolol was not demonstrated in this population with baseline IOP ≥25 mmHg and <30 mmHg (Table 2).
Maltese: Netarsudil wera tnaqqis klinikament relevanti fl-IOP fil-punti ta' żmien kollha, iżda n-nuqqas ta' inferjorità ta' timolol ma ntweriex f'din il popolazzjoni b'linja bażi tal-IOP ≥ 25 mmHg u < 30 mmHg (Tabella 2).
English: The safety of netarsudil has been evaluated in clinical studies, including four well-controlled Phase 3 studies.
Maltese: Is-sigurtà ta' netarsudil ġiet evalwata fi studji kliniċi, inklużi erba' studji tal-Fażi 3 ikkontrollati sew.
English: Table 2: Mean IOP by visit: PP population with baseline IOP ≥25 and <30 mmHg Study Visit and Time Point
Maltese: Tabella 2: IOP medju skont iż-żjara: Popolazzjoni PP b'linja bażi tal-IOP ≥25 u <30 mmHg Żjara ta' Studju u Punt ta' Żmien
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of solution contains 200 micrograms netarsudil (as mesylate).
Maltese: 1 ml ta' soluzzjoni fih 200 mikrogramma netarsudil (bħala mesylate).
English: Only one plasma concentration at 0.11 ng/ml for the active metabolite was observed for one subject on day 8 at 8 hours post-dose.
Maltese: Ġiet osservata biss konċentrazzjoni ta' plażma waħda għal 0.11 ng/ml għall-metabolit attiv għal individwu wieħed f'jum 8 fi 8 sigħat wara d-doża.
English: visual field defect
Maltese: Informazzjoni għall-pazjent
English: Use in adults, including the elderly
Maltese: Użu fl-adulti, inkluż l-anzjani
English: The study was designed to show non-inferiority of netarsudil when dosed once daily in the evening to timolol maleate 0.5% dosed twice daily in patients with a baseline IOP of >20 mmHg and <25 mmHg.
Maltese: L-istudju kien imfassal biex juri nuqqas ta' inferjorità ta' netarsudil meta jiġi ddożat darba kuljum filgħaxija għal timolol maleate 0.5 % iddożat darbtejn kuljum f'pazjenti b'linja bażi tal-IOP ta' >20 mmHg u <25 mmHg.
English: Pharmacotherapeutic group: Ophthalmologicals, antiglaucoma preparations and miotics, ATC code: S01EX05
Maltese: Oftalmoloġiċi, preparazzjonijiet u mijotiċi kontra l-glawkoma, kodiċi
English: After topical ocular dosing, netarsudil is metabolised by esterases in the eye to an active metabolite, AR-13503.
Maltese: Assorbiment L-esponiment sistemiku ta' netarsudil u l-metabolit attiv tiegħu, AR-13503, ġew evalwati fi 18
English: Uncommon ocular hyperaemia, blepharitis, corneal disorder, eyelid margin crusting, eye allergy, conjunctival follicles, ocular discomfort, eye swelling, corneal deposits, eyelid disorder, meibomian gland dysfuntion, corneal pigmentation, diplopia, ectropion, lenticular opacities, noninfective conjunctivitis, abnormal sensation in the eye, asthenopia, episcleral hyperaemia, halo vision, keratitis, refraction disorder, anterior chamber flare, anterior chamber inflammation, blindness, conjunctival irritation, conjunctivochalasis, diabetic retinopathy, eczema eyelids, eyelid skin dryness, glaucoma, growth of eyelashes, iris adhesions, iris bombe, iritis, ocular hypertension, visual impairment, corneal dystrophy, instillation site foreign body sensation, instillation site irritation, glassy eyes, fatigue, instillation site dryness, instillation site oedema, instillation site paraesthesia, conjunctival staining, optic nerve cup/disc ratio increased, madarosis
Maltese: Żieda fil-pressjoni tal-fluwidu ġol-għajn; infjammazzjoni tal-parti kkulurita talgħajn (l-iris); l-iris toħroġ 'il barra; tkabbir tax-xagħar tal-għajnejn; nixfa tal-kappell tal-għajn; marda tal-għajnejn relatata mad-dijabete; tinjiet eċċessivi tal-konġuntiva; għama; tara mċajpar, doppju jew b'raġġiera madwar l-oġġetti; kataretti; tidwir anormali 'l barra tal-kappell tal-għajn t'isfel; tikek żgħar bil-kulur fuq il-wiċċ tal-għajn; nixfa tal-għajnejn ikkawżata minn infjammazzjoni tal-glandoli tal-għajnejn; allerġija fl-għajnejn, qxur fil-kappell tal-għajn; għajnejn ileqqu; telf tax-xagħar tal-għajnejn; għeja
English: This medicinal product contains benzalkonium chloride.
Maltese: Dan il-prodott mediċinali fih benzalkonium chloride.
English: LIST OF EXCIPIENTS
Maltese: Mhux komuni eksorjazzjoni
English: Each ml of solution contains 200 micrograms netarsudil (as mesylate).
Maltese: Kull ml ta' soluzzjoni fih 200 mikrogramma netarsudil (bħala mesylate).
English: The IOP reduction with netarsudil dosed once daily was non-inferior to the effect of timolol 0.5% dosed twice daily in patients with baseline IOP of <25 mmHg (Table 1).
Maltese: It-tnaqqis talIOP b'netarsudil iddożat darba kuljum ma kienx inferjuri għall-effett ta' timolol 0.5 % iddożat darbtejn kuljum f'pazjenti b'linja bażi tal-IOP ta' < 25 mmHg (Tabella 1).
English: The incidence of cornea verticillata was higher in certain subpopulations: elderly (≥65 years) versus non-elderly (24.8 vs. 15.9%); males versus females (24.4 vs. 18.4%) and in white versus other races (25.6 vs. 7.0%).
Maltese: L-inċidenza ta' kornea vertikillata kienet ogħla f'ċerti sottopopolazzjonijiet: anzjani (≥65 sena) kontra mhux anzjani (24.8 vs. 15.
English: • General side effects: Increased allergic symptoms; dizziness; blurred vision; nasal discomfort and pain; redness or itching of the skin; rash on skin; inflammation of the cartilage; picking of the skin
Maltese: • Effetti sekondarji oħra: Żieda fis-sintomi tal-allerġija; sturdament; vista mċajpra; skumdità u wġigħ fl-imnieħer; ħmura jew ħakk tal-ġilda; raxx fuq il-ġilda; infjammazzjoni tal-kartiliġġ;
English: However, while no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding women to netarsudil is expected to be negligible, no relevant clinical data are available (see section 5.2).
Maltese: Madankollu, filwaqt li l-ebda effett fuq it-tarbija tat-twelid/tarbija mreddgħa ma huma antiċipati peress li l-esponiment sistemiku tan-nisa li qed ireddgħu għal netarsudil huwa mistenni li jkun negliġibbli, ma hemm l-ebda data klinika relevanti disponibbli (ara sezzjoni 5.2).
English: If netarsudil is to be used concomitantly with other topical ophthalmic medicinal products, each medicinal product should be administered at least five (5) minutes apart.
Maltese: Jekk netarsudil ser jintuża flimkien ma' prodotti mediċinali oftalmiċi topiċi oħra, kull prodott mediċinali għandu jingħata mill-inqas ħames (5) minuti minn xulxin.
English: Rhokiinsa should not be used in children and teenagers under 18 years of age as it has only been studied in adults.
Maltese: Rhokiinsa m'għandux jintuża fit-tfal jew f'adolexxenti taħt l-età ta' 18-il sena peress li ġie studjat fuq adulti biss.
English: Conjunctival Hyperaemia
Maltese: Iperemija Konġuntivali
English: Respiratory, thoracic and mediastinal disorders Uncommon nasal discomfort, rhinalgia
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Common headache Uncommon dizziness,
Maltese: Mhux komuni dermatite allerġika,
English: Rhokiinsa contains an active substance called netarsudil.
Maltese: Rhokiinsa fih sustanza attiva msejħa netarsudil.
English: In pregnant rabbits, 3 mg/kg/day (10000 times the recommended ophthalmic dose) and higher showed an increase in post-implantation loss and a decrease in foetal weight.
Maltese: Fi fniek tqal, 3 mg/kg/jum (10000 darba tad-doża oftalmika rakkomandata) u ogħla wriet żieda fit-telf ta' wara l-impjant u tnaqqis fil-piż tal-fetu.
English: The incidences of hyperemia and vision blurred were sporadic in nature.
Maltese: L-inċidenzi ta' iperemja u vista mċajpra kienu ta' natura sporadika.