FrancophonIA/ELRC3.0 huggingface dataset:
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: Arginine hydrochloride
Maltese: EFFETTI MHUX MIXTIEQA
English: Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 0.8 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 10 kunjetti ta' 1 doża lyophilisate u 10 kunjetti ta' 0.8 ml ta' solvent.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Lyophilisate u solvent għal soluzzjoni għall-injezzjoni. Lyophilisate abjad
English: Plastic box containing 100 vials of 1 dose of lyophilisate and 100 vials of 0.8 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 100 kunjett ta' 1 doża lyophilisate u 100 kunjett ta' 0.8 ml ta' solvent.
English: De-worming of infested dogs prior to vaccination is recommended.
Maltese: Laqqam annimali f'saħħithom u mhux infettati biss.
English: Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 0.8 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 50 kunjett ta' 1 doża lyophilisate u 50 kunjett ta' 0.8 ml ta' solvent.
English: Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 0.8 ml of solvent.
Maltese: Kaxxa tal-plastik li fiha 1 kunjett ta' 1 doża lyophilisate u 1 kunjett ta' 0.8 ml ta' solvent.
English: Reconstitute one vial of the white lyophilisate using 0.5 ml of the solvent.
Maltese: B'MOD KORRETT Irrikostitwixxi kunjett wieħed ta' lyophilisate abjad permezz ta' 0.5 ml tas-solvent.
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPANJA) Puh/Tel: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPANJA) Puh/Tel: + 34 91 771 17 90
English: LETIFEND, lyophilisate and solvent for solution for injection for dogs
Maltese: VETERINARJU LETIFEND, lyophilisate u solvent għal soluzzjoni għall-injezzjoni għall-klieb
English: Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor, ħlief mas-solvent għal użu ma dan il-prodott mediċinali veterinarju.
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANJE)
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ESPAÑA)
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIEN)
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIEN)
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPÁNN) Sími: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPÁNN) Sími: + 34 91 771 17 90
English: The manufacture, import, possession, sale, supply and/or use of LETIFEND may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu ta' LETIFEND huwa pprojbit jew jista' jkun ipprojbit f'ċerti Stati Membri fit-territorju kollu tagħhom jew f'parti minnu taħt leġiżlazzjoni nazzjonali.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 dose
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 1 doża
English: Lyophilisate and solvent for solution for injection.
Maltese: Lyophilisate u solvent għal soluzzjoni għall-injezzjoni.
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANYOLORSZÁG) Tel.: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANYOLORSZÁG) Tel.: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madride (SPĀNIJA) Tel: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madride (SPĀNIJA) Tel: + 34 91 771 17 90
English: Primary vaccination scheme: A single dose of the vaccine (0.5 ml) to be administered to dogs from 6 months of age.
Maltese: Skema primarja ta' tilqim: Doża waħda tal-vaċċin (0.5 ml) li għandha tingħata lill-klieb li jkollhom 6 xhur ‘il fuq.
English: Following administration of a double dose, reactions are similar in nature to those observed following the administration of a single dose (see section 4.6).
Maltese: Wara l-għoti ta' doża doppja, ir-reazzjonijiet huma simili fin-natura tagħhom għal dawk osservati wara l-għoti ta' doża waħda (ara sezzjoni 4.6).
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madridas (ISPANIJA) Tel: +34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madridas (ISPANIJA) Tel: +34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANIEN) Tel: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (SPANJE) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANJOLSKA) Tel: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANJOLSKA) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANIJA) Tel: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANIJA) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANĚLSKO) Tel: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANĚLSKO) Tel: + 34 91 771 17 90
English: unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANIELSKO) Tel: + 34 91 771 17 90
Maltese: Laboratorios LETI, S.L. unipersonal C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid (ŠPANIELSKO) Tel: + 34 91 771 17 90
English: EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 Annonay France
Maltese: EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 Annonay Franza
English: Verkazia contains cetalkonium chloride
Maltese: Cetalkonium chloride
English: Mean age was 9.2 years (SD: 3.3, age range: 4-17 years).
Maltese: Letà medja kienet ta' 9.2 snin (SD: 3.3, firxa ta' età: 4-17-il sena).
English: MedDRA frequency
Maltese: Frekwenza ta' MedDRA
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE verkazia
English: Children from 4 years of age and adolescents
Maltese: Tfal ta' età minn 4 snin 'il fuq u adolexxenti
English: Fertility There are no data on the effects of Verkazia on human fertility.
Maltese: Fertilità M'hemmx dejta dwar l-effetti ta' Verkazia fuq il-fertilità umana.
English: Santen UK Limited Tel: +44 (0) 345 075 4863
Maltese: United Kingdom Santen UK Limited Tel: +44 (0) 345 075 4863
English: There were more male [n=132 (78.6%)] than female patients [n=36 (21.4%)].
Maltese: Kien hemm aktar pazjenti rġiel [n=132 (78.6%)] minn pazjenti nisa [n=36 (21.4%)].
English: They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Maltese: Huma kklassifikati skont il-klassi tas-sistemi u tal-organi u skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), jew mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Santen Oy Niittyhaankatu 20 33720 Tampere FINLAND
Maltese: Santen Oy Niittyhaankatu 20 33720 Tampere Il-Finlandja
English: The difference in the Least Square (LS) mean vs. vehicle was 0.76 (95% CI: 0.26, 1.27) for the high dose group and 0.67 (95% CI: 0.16, 1.18) for the low dose group.
Maltese: Id-differenza fil-medja ta' Least Square (LS) vs. is-sustanza mingħajr il-mediċina attiva kienet 0.76 (CI ta' 95%: 0.26, 1.27) għall-grupp ta' doża għolja u 0.67 (CI ta' 95%: 0.16, 1.18) għall-grupp ta' doża baxxa.
English: Blood concentrations of Verkazia were measured using a specific high-pressure liquid chromatography-mass spectrometry assay.
Maltese: Konċentrazzjonijiet fid-demm ta' Verkazia kienu mkejla permezz ta' analiżi speċifika ta' high pressure liquid chromatography-mass spectrometry.
English: Pack sizes: 30, 60, 90 and 120 single-dose containers.
Maltese: Daqsijiet tal-pakkett: 30, 60, 90 u 120 kontenitur b'doża waħda.
English: Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.
Maltese: Trattament ta' keratokonġuntivite vernali severa (VKC - vernal keratoconjunctivitis) fi tfal ta' età minn 4 snin 'il fuq u adolexxenti.
English: Upper respiratory tract infection.
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq.
English: Eye infection caused by herpes zoster virus.
Maltese: Infezzjoni flgħajn kkawżata mill-virus herpes zoster.
English: Santen Oy Tél/Tel : +352 (0) 27862006
Maltese: Tél/Tel : +352 (0) 27862006
English: One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4).
Maltese: Eċċipjent b'effett magħruf: mL wieħed ta' emulsjoni fih 0.05 mg ta' cetalkonium chloride (ara sezzjoni 4.4).
English: Santen Oy Tel: : +420 234 102 170
Maltese: Tel: : +420 234 102 170
English: Pack sizes of 30, 60, 90 or 120 single-dose containers.
Maltese: Daqsijiet tal-pakkett ta' 30, 60, 90 jew 120 kontenitur b'doża waħda.
English: Verkazia contains the active ingredient, ciclosporin.
Maltese: X'fih Verkazia - Is-sustanza attiva hi ciclosporin.
English: Santen Oy Tel: +36 (06) 16777305
Maltese: Tel: +36 (06) 16777305
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Trigliċeridi ta' katina medja
English: In a 12 month double-masked, vehicle controlled, pivotal clinical trial (VEKTIS study), 169 patients with severe VKC and severe keratitis (grade 4 or 5 on the modified Oxford scale) were randomised to 4 drops of Verkazia (high dose) or 2 drops of Verkazia (low dose) and 2 drops of vehicle or 4 drops of vehicle for the first 4 months (Period 1).
Maltese: Fi prova klinika pivitali ta' 12-il xahar, double-masked, ikkontrollata bis-sustanza mingħajr ilmediċina attiva (studju VEKTIS), 169 pazjent b'VKC severa u keratite severa (grad 4 jew 5 fuq liskala modifikata ta' Oxford) ġew randomised biex jirċievu 4 qatriet ta' Verkazia (doża għolja) jew 2 qatriet ta' Verkazia (doża baxxa) u 2 qatriet tas-sustanza mingħajr il-mediċina attiva jew 4 qatriet tas-sustanza mingħajr il-mediċina attiva għall-ewwel 4 xhur (Perjodu 1).
English: The most common adverse reactions in the clinicial trials with Verkazia were eye pain (11%) and eye pruritus (9%) which were usually transitory and occurred during instillation.
Maltese: L-aktar reazzjonijiet avversi komuni fil-provi kliniċi b'Verkazia kienu uġigħ fl-għajnejn (11%) u ħakk fl-għajnejn (9%) li ġeneralment kienu temporanji u seħħew waqt it-tqattir.
English: No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section 5.3).
Maltese: Ma kienx irrappurtat indeboliment fil-fertilità f'annimali li rċevew ciclosporin fil-vini (ara sezzjoni 5.3).
English: Santen Oy Tel: +351 308 805 912
Maltese: Tel: +351 308 805 912
English: 5 single-dose containers.
Maltese: 5 kontenituri b'doża waħda.
English: Uncommon Keratitis bacterial, herpes zoster ophthalmic.
Maltese: Mhux komuni Keratite kkawżata minn batterja, herpes zoster flgħajnejn.
English: 0.3 mL single-dose, low-density polyethylene (LDPE) containers in a sealed laminate aluminium pouch.
Maltese: Kontenituri ta' 0.3 mL b'doża waħda magħmula minn polyethylene ta' densità baxxa (LDPE - lowdensity polyethylene) f'borża żgħira issiġillata tal-aluminju laminat.
English: 30 single-dose containers 60 single-dose containers 90 single-dose containers 120 single-dose containers
Maltese: Qtar għall-għajnejn, emulsjoni 30 kontenitur b'doża waħda 60 kontenitur b'doża waħda 90 kontenitur b'doża waħda 120 kontenitur b'doża waħda
English: Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies.
Maltese: Prodotti mediċinali għall-għajnejn, li jaffettwaw is-sistema immuni, inkluż ciclosporin, jistgħu jaffettwaw id-difiżi tal-ospitanti kontra infezzjonijiet lokali u tumuri malinni.
English: Santen Oy Tel: +353 (0) 16950008
Maltese: Tel: +353 (0) 16950008
English: Uncommon Blepharitis, conjunctival oedema.
Maltese: Mhux komuni Blefarite, edima fil-konġuntiva.
English: One millilitre of Verkazia contains 1 mg of ciclosporin.
Maltese: Millilitru wieħed ta' Verkazia fih 1 mg ta' ciclosporin.
English: The following adverse reactions listed below were observed in clinical studies.
Maltese: Ir-reazzjonijiet avversi li ġejjin elenkati taħt kienu osservati fi studji kliniċi.
English: In 166 patients at baseline from one efficacy study (55 patients in the high dose group, 53 in the low dose group and 58 in the vehicle group), plasma concentrations of ciclosporin were measured before administration and after 2, 4 and 12 months of treatment.
Maltese: F'166 pazjent fil-linja bażi minn studju wieħed tal-effikaċja (55 pazjent fil-grupp ta' doża għolja, 53 fil-grupp ta' doża baxxa u 58 fil-grupp tassustanza mingħajr il-mediċina attiva), il-konċentrazzjonijiet ta' ciclosporin fil-plażma ġew imkejla qabel l-għoti u wara 2, 4 u 12-il xahar ta' trattament.
English: Santen Oy Τηλ: +358 (0) 3 284 8111
Maltese: Τηλ: +358 (0) 3 284 8111
English: Both differences were statistically significant with p=0.007 for the high dose and p=0.010 for the low dose group.
Maltese: Iż-żewġ differenzi kienu statistikament sinifikanti b'p=0.007 għall-grupp ta' doża għolja u p=0.010 għall-grupp ta' doża baxxa.
English: Verkazia should be administered last (see section 4.4).
Maltese: Verkazia għandu jingħata l-aħħar (ara sezzjoni 4.4).
English: Verkazia has not been studied in adult patients.
Maltese: Verkazia ma ġiex studjat f'pazjenti adulti.
English: A responder was defined as a patient 1) with a mean CFS score over the 4 months of treatment ≤ 50% of baseline, 2) who did not withdraw from the study for a reason possibly due to treatment, 3) with no experience of corneal ulceration and 4) no use of rescue medicinal product in the last 4 months of treatment.
Maltese: Persuna b'rispons kienet definita bħala pazjent 1) b'punteġġ medju ta' CFS matul l-4 xhur ta' trattament ta' ≤ 50% tal-linja bażi, 2) li ma rtiratx mill-istudju għal raġuni possibilment minħabba ttrattament, 3) mingħajr esperjenza ta' ulċeri fil-kornea u 4) bl-ebda użu ta' prodott mediċinali ta' salvataġġ fl-aħħar 4 xhur ta' trattament.
English: The improvement was clinically relevant as illustrated by the effect size over 4 months (symptoms domain: 0.67 and daily activities domain: 0.44).
Maltese: It-titjib kien klinikament rilevanti kif jidher mid-daqs tal-effett fuq 4 xhur (dominju tas-sintomi: 0.67 u dominju ta' attivitajiet ta' kuljum: 0.44).
English: How to store Verkazia 6.
Maltese: Kif taħżen Verkazia 6.
English: Ciclosporin inhibits histamine release from mast cells and basophils through a reduction in IL-5 production, and may reduce eosinophil recruitment and effects on the conjunctiva and cornea.
Maltese: Ciclosporin jinibixxi r-rilaxx talistamina minn ċelluli mast u basofili permezz ta' tnaqqis fil-produzzjoni ta' IL-5, u jista' jnaqqas irreklutaġġ ta' eożinofili u effetti fuq il-konġuntiva u l-kornea.
English: Medium-chain triglycerides Cetalkonium chloride Glycerol
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI
English: In the low dose group, after 4 months of ocular instillation of Verkazia 2 times daily (n= 47 patients), 34 patients had values below the lower limit of detection (0.050 ng/mL) and 7 patients had values below the lower limit of quantification (0.100 ng/mL).
Maltese: Fil-grupp ta' doża baxxa, wara 4 xhur ta' tqattir ta' Verkazia darbtejn kuljum fl-għajnejn (n=47 pazjent), 34 pazjent kellhom valuri taħt il-limitu l-aktar baxx ta' osservazzjoni (0.050 ng/mL) u 7 pazjenti kellhom valuri taħt il-limitu l-aktar baxx ta' kwantifikazzjoni (0.100 ng/mL).
English: A single-dose container of 0.3 mL eye drops emulsion contains 0.3 mg of ciclosporin.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kontenitur b'doża waħda b'0.3 mL ta' emulsjoni ta' qtar għall-għajnejn fih 0.3 mg ta' ciclosporin.
English: It is supplied in single-dose containers made of a low-density polyethylene (LDPE).
Maltese: Huwa fornut f'kontenituri ta' doża waħda magħmula minn polyethylene ta' densità baxxa (LDPE
English: If you use drops in both eyes, repeat the steps 6 to 9 for your other eye. 12.
Maltese: Jekk tuża qtar f'għajnejk it-tnejn, irrepeti l-passi 6 sa 9 għall-għajnek l-oħra.
English: Santen Oy Sími: +358 (0) 3 284 8111
Maltese: Tel: +358 (0) 3 284 8111
English: In the high dose group after 4 months of ocular instillation of Verkazia 4 times daily (n=50), 20 patients had values below the lower limit of detection (0.050 ng/mL) and 13 patients had values below the lower limit of quantification (0.100 ng/mL).
Maltese: Fil-grupp ta' doża għolja wara 4 xhur ta' tqattir ta' Verkazia 4 darbiet kuljum fl-għajnejn (n=50), 20 pazjent kellhom valuri taħt il-limitu l-aktar baxx ta' osservazzjoni (0.050 ng/mL) u 13-il pazjent kellhom valuri taħt il-limitu l-aktar baxx ta' kwantifikazzjoni (0.100 ng/mL).
English: 168 patients [127 children (75.6%) and 41 adolescents (24.4%)] were included in the efficacy analyses.
Maltese: 6%) u 41 adolexxenti (24.4%)] ġew inklużi fl-analiżi tal-effikaċja.
English: Mechanism of action and pharmacodynamic effects Following ocular administration, ciclosporin is passively absorbed by T-lymphocytes where its binding to cyclophilin A inactivates calcineurin, and prevents NF-AT translocation into the nucleus, thus blocking the release of pro-inflammatory cytokines such as IL-2 and hence T-lymphocyte activation.
Maltese: Wara għoti fl-għajnejn, ciclosporin jiġi assorbit b'mod passiv minn limfoċiti T fejn l-irbit tiegħu ma' cyclophilin A jinattiva calcineurin u jipprevjeni t-traslokazzjoni
English: Verkazia, 1 mg/mL eye drops, emulsion ciclosporin
Maltese: Verkazia, 1 mg/mL qtar għall-għajnejn, emulsjoni ciclosporin
English: Rescue medicinal product (topical steroids) was used more often in the vehicle than in the high dose regimen: 32.1% in the high dose group and 31.5% in the low dose group received at least one course of rescue medicinal product while they were 53.4% in the vehicle group.
Maltese: 32.1% fil-grupp ta' doża għolja u 31.5% fil-grupp ta' doża baxxa rċevew mill-inqas kors wieħed ta' prodott mediċinali ta' salvataġġ waqt li dawn kienu 53.4% fil-grupp tas-sustanza mingħajr il-mediċina attiva.
English: Excipient Verkazia contains cetalkonium chloride which may cause eye irritation.
Maltese: Verkazia fih cetalkonium chloride Cetalkonium chloride jista' jikkawża irritazzjoni fl-għajnejn.
English: Common side effects related to the eye:
Maltese: Effetti sekondarji komuni relatati mal-għajn:
English: Verkazia 1 mg/mL eye drops, emulsion ciclosporin
Maltese: Verkazia 1 mg/mL qtar għall-għajnejn, emulsjoni ciclosporin
English: One mL of emulsion contains 1 mg of ciclosporin.
Maltese: U KWANTITATTIVA mL wieħed ta' emulsjoni fih 1 mg ta' ciclosporin.
English: Keep single-dose containers in the pouch in order to protect from light and avoid evaporation.
Maltese: Żomm il-kontenituri ta' doża waħda fil-borża ż-żgħira sabiex tilqa' mid-dawl u tiġi evitata evaporazzjoni.
English: Eye pruritus, ocular hyperaemia, eye irritation, ocular discomfort, foreign body sensation in eyes, lacrimation increased, vision blurred, erythema of eyelid, eyelid oedema.
Maltese: Ħakk fl-għajnejn, iperimija fl-għajnejn, irritazzjoni flgħajnejn, skumdità fl-għajnejn, sensazzjoni ta' oġġett barrani fl-għajnejn, żieda fid-dmugħ, vista mċajpra, eritema fil-kappell tal-għajnejn, edima fil-kappell talgħajnejn.
English: verkazia
Maltese: Pożoloġija
English: Do not use Verkazia in children under the age of 4 years.
Maltese: Tfal u adolexxenti Tużax Verkazia fi tfal taħt l-età ta' 4 snin.
English: The primary efficacy endpoint which was the average penalties adjusted change of the Corneal Fluorescein Staining (CFS) score from baseline and over Period 1, considered all patients (n=168).
Maltese: Il-punt finali primarju tal-effikaċja li kien il-bidla medja aġġustata għall-pieni tal-punteġġ ta' Tbajja ta' Fluorescein fil-Kornea (CFS - Corneal Fluorescein Staining) mil-linja bażi u matul Perjodu 1, ikkunsidrati l-pazjenti kollha (n=168).
English: For the average of VKC symptoms, the difference in the LS mean vs. vehicle in the high dose group was statistically significant at all time points compared to vehicle: -19.4 mm (p<0.05).
Maltese: Għall-medja tas-sintomi ta' VKC, id-differenza fil-medja ta' LS vs. is-sustanza mingħajr il-mediċina attiva fil-grupp ta' doża għolja kienet statistikament sinifikanti fil-punti ta' ħin kollha meta mqabbla mas-sustanza mingħajr il-mediċina attiva: -19.4 mm (p<0.05).
English: The excess rate with respect to vehicle was 27.8% for the high dose regimen and 22.4% for the low dose one.
Maltese: Ir-rata ta' eċċess rigward is-sustanza mingħajr ilmediċina attiva kienet ta' 27.8% għall-kors ta' doża għolja u ta' 22.4% għal dak ta' doża baxxa.
English: Verkazia 1 mg/mL eye drops, emulsion
Maltese: Verkazia 1 mg/mL qtar għall-għajnejn, emulsjoni
English: At Month 12, (n= 68 patients) values were below the lower limit of detection for 38 patients and below the lower limit of quantification in 10 patients.
Maltese: F'Xahar 12, (n= 68 pazjent) il-valuri kienu taħt il-limitu l-aktar baxx ta' osservazzjoni għal 38 pazjent u taħt il-limitu l-aktar baxx ta' kwantifikazzjoni f'10 pazjenti.
English: Eye drops, emulsion.
Maltese: GĦAMLA FARMAĊEWTIKA Qtar għall-għajnejn, emulsjoni.
English: Combination with other medicinal products that affect the immune system Co-administration of Verkazia with eye drops containing corticosteroids may potentiate the effects of Verkazia on the immune system.
Maltese: Kombinazzjoni ma' prodotti mediċinali oħra li jaffettwaw is-sistema immuni L-għoti ta' Verkazia flimkien ma' qtar għall-għajnejn li fihom kortikosterojdi jista' jsaħħaħ l-effetti ta' Verkazia fuq is-sistema immuni.
English: Twist off the cap (picture 1)
Maltese: Neħħi l-għatu billi ddawwar (stampa 1)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, phototoxicity and photoallergy, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, fototossiċita u fotoallerġija, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.