FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean IOP reduction at Week 12 in the 2 months to <3 years of age group was 1.8 mmHg in the travoprost group and 7.3 mmHg in the timolol group.
Maltese: It-tnaqqis medju flIOP f'Ġimgħa 12 fil-grupp ta' età ta' xahrejn sa <3 snin kien ta' 1.8 mmHg fil-grupp ta' travoprost u 7.3 mmHg fil-grupp ta' timolol.
English: One mL of solution contains 7.5 mg propylene glycol and 2 mg polyoxyethylene hydrogenated castor oil 40 (HCO-40) (see section 4.4).
Maltese: ML wieħed ta' soluzzjoni fih 7.5 mg propylene glycol u 2 mg polyoxyethylene hydrogenated castor oil 40 (HCO-40)
English: Opened (2)
Maltese: Infetaħ (2)
English: Secondary pharmacology
Maltese: Farmakoloġija sekondarja
English: The following side effects have been observed with IZBA:
Maltese: L-effetti sekondarji li ġejjin kienu osservati b'IZBA:
English: Not known chest pain, bradycardia, tachycardia, arrhythmia
Maltese: Mhux magħrufa uġigħ fis-sider, bradikardija, takikardija, arritmija
English: Hyperaemia (ocular or conjunctival) was observed in 11.8% of patients (N=442) exposed to IZBA compared with 14.5% observed for patients exposed to travoprost 40 µg/mL eye drops, solution, benzalkonium chloride preserved.
Maltese: Iperimija (okulari jew talkonġuntiva) kienet osservata fi 11.8% tal-pazjenti (N=442) esposti għal IZBA meta mqabbel ma' 14.5% osservat għall-pazjenti esposti għal travoprost 40 µg/mL qtar għall-għajnejn, soluzzjoni, ippreservat b'benzalkonium chloride.
English: S.A. Alcon Couvreur N.V. Rijksweg 14
Maltese: S.A. Alcon Couvreur N.V.
English: Table 3 IOP change from baseline (mmHg) for IZBA
Maltese: Tabella 3: Bidla fl-IOP mil-linja bażi (mmHg) għal IZBA
English: Patients received either travoprost 0.004% once daily or timolol 0.5% (or 0.25% for subjects younger than 3 years old) twice daily.
Maltese: Il-pazjenti rċevew jew travoprost 0.004% darba kuljum jew timolol 0.5% (jew 0.25% għall-individiwi iżgħar minn 3 snin) darbtejn kuljum.
English: The following adverse reactions were assessed to be related with travoprost 40 µg/mL eye drops, solution (either benzalkonium chloride [BAK] or Polyquad-preserved) 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 <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu stmati li huma relatati ma' travoprost 40 µg/mL qtar għallgħajnejn, soluzzjoni (b'benzalkonium chloride [BAK] jew ippreservat Polyquad) u huma kklassifikati skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa ≤1/10), mhux komuni (≥1/1,000 sa ≤1/100), rari (≥1/10,000 sa ≤1/1,000), rari ħafna (≤1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: The following adverse reactions were assessed to be related with IZBA monotherapy 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 <1/1,000) and very rare (<1/10,000).
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu stmati li huma relatati ma' monoterapija ta' IZBA u huma kklassifikati skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa ≤1/10), mhux komuni (≥1/1,000 sa ≤1/100), rari (≥1/10,000 sa ≤1/1,000) u rari ħafna (≤1/10,000).
English: In a 3-month phase 3 study and a 7-day pharmacokinetic study, involving 102 paediatric patients exposed to travoprost 40 micrograms/mL eye drops, solution, the types and characteristics of adverse reactions reported were similar to what has been observed in adult patients.
Maltese: Fi studju ta' 3 xhur ta' fażi 3 u studju farmakokinetiku ta' 7 ijiem, li jinvolvi 102 pazjenti pedjatriċi esposti għal travoprost 40 mikrogramma/mL qtar għall-għajnejn, soluzzjoni, it-tipi u l-karatteristiċi ta' reazzjonijiet avversi rrappurtati kienu simili għal dawk li ġew osservat f'pazjenti adulti.
English: Macular oedema has been reported during treatment with prostaglandin F2a analogues.
Maltese: Edima makulari ġiet irrappurtata waqt trattament b'analogi ta' prostaglandin F2a.
English: A pharmacokinetic study of TRAVATAN (travoprost 40 micrograms/mL eye drops, solution) in paediatric patients aged 2 months to <18 years demonstrated low plasma exposure to travoprost free acid, with concentrations ranging from below the 10 pg/mL assay limit of quantitation (BLQ) to 54.5 pg/mL.
Maltese: Studju farmakokinetiku ta' TRAVATAN (travoprost 40 mikrogramma/mL qtar għall-għajnejn, soluzzjoni) f'pazjenti pedjatriċi b'età ta xahrejn sa <18-il sena wera esponiment baxx fil-plażma għallaċidu liberu ta' travoprost, b'konċentrazzjonijiet li jvarjaw minn anqas mil-limitu ta' assaġġ ta' kwantitazzjoni (BLQ) ta' 10 pg/mL għal 54.5 pg/mL.
English: Not known asthma aggravated, epistaxis
Maltese: Mhux magħrufa aggravar tal-ażżma, epistassi
English: Use in adults, including elderly patients
Maltese: Użu fl-adulti, inkluż pazjenti anzjani
English: Uncommon hypersensitivity, seasonal allergy
Maltese: Mhux Komuni sensittività eċċessiva, allerġija tal-istaġun
English: 1 bottle of 2.5 mL 3 bottles of 2.5 mL
Maltese: Flixkun wieħed ta' 2.5 mL 3 flixken ta' 2.5 mL
English: Sodium hydroxide and/or hydrochloric acid (to adjust pH) Purified water
Maltese: Sodium hydroxide u/jew hydochloric acid (għall-aġġustament tal-pH) Ilma ppurifikat
English: - The other ingredients are: polyquaternium-1, polyoxyethylene hydrogenated castor oil 40, propylene glycol (see end of section 2), sodium chloride, boric acid, mannitol and purified water.
Maltese: - Is-sustanzi l-oħra huma: polyquaternium-1, polyoxyethylene hydrogenated castor oil 40, propylene glycol (ara l-aħħar ta' sezzjoni 2), sodium chloride, boric acid, mannitol, u ilma ppurifikat.
English: Not known: frequency cannot be estimated from the available data
Maltese: Mhux magħrufa: il-frekwenza ma tistax tiġi stmata mid-data disponibbli
English: Pharmacotherapeutic group: Ophthalmologicals, antiglaucoma preparations and miotics, ATC code: S01EE04
Maltese: Oftalmoloġiċi, preparazzjonijiet kontra l-glawkoma u mijotiċi, Kodiċi ATC:
English: • Travoprost may be absorbed through the skin.
Maltese: • Travoprost jista' jiġi assorbit mill-ġilda.
English: Additional adverse reactions reported in paediatric patients in the 3-month paediatric study (n=77) compared to a similar trial in adults (n=185) included erythema of eyelid, keratitis, lacrimation increased, and photophobia, all reported as single events with an incidence of 1.3% versus 0.0% seen in adults.
Maltese: Reazzjonijiet avversi oħrajn irrappurtati f'pazjenti pedjatriċi fl-istudju pedjatriku ta' 3 xhur (n=77) meta mqabbel ma' prova simili fl-adulti (n=185) inkludew eritema fit-teqbet tal-għajn, keratite, żieda fid-dmugħ, u fotofobija, li kollha huma rrappurtati bħala avvenimenti waħdiena b'inċidenza ta' 1.3% meta mqabbel ma' 0.0% osservati fl-adulti.
English: Uncommon palpitations
Maltese: Mhux Komuni palpitazzjonijiet
English: Rare peptic ulcer reactivated, dry mouth gastrointestinal disorder, constipation
Maltese: Rari riattivazzjoni ta' ulċera peptika, ħalq xott, disturb gastro-intestinali, stitikezza
English: Opened (3)
Maltese: Infetaħ (3)
English: Rare dermatitis allergic, , dermatitis contact, erythema, rash, hair colour changes, madarosis
Maltese: Rari dermatite allerġika, dermatite tal-kuntatt, eritema, raxx, bidla fil-kulur tax-xagħar, telf tax-xagħar tal-ħuġbejn
English: IZBA 30 micrograms/mL eye drops travoprost
Maltese: IZBA 30 mikrogramma/mL qtar għall-għajnejn travoprost
English: EU/1/13/905/001-002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/905/001-002
English: Rare dysgeusia, dizziness, visual field defect
Maltese: Rari disġewżja, sturdament, difett fil-kamp tal-vista
English: Uncommon pruritus, rash
Maltese: Mhux komuni ħakk, raxx
English: Table 2 Travoprost 40 µg/mL eye drops, solution
Maltese: Tabella 2 Travoprost 40 µg/mL qtar għall-għajnejn, soluzzjoni
English: The systemic metabolic pathways parallel those of endogenous prostaglandin F2 which are characterised by reduction of the double bond in position C13-C14, oxidation of the 15-hydroxyl and -oxidative cleavages of the upper side chain.
Maltese: Ir-rotot metaboliċi fil-ġisem jixbħu lil dawk ta' prostaglandin F2α endoġenu u huma kkaratterizzati minn tnaqqis tad-double bond fil-pożizzjoni C13-C14, u ossidazzjoni tal-qsim 15-hydroxy u β-oxidative tal-katina tat-tarf tan-naħa ta' fuq.
English: Peak active free acid plasma concentrations of 25 pg/mL or less were observed between 10 and 30 minutes post-dose.
Maltese: Konċentrazzjonijiet massimi tal-aċidu ħieles attiv fil-plażma ta' 25 pg/mL jew inqas kienu osservati minn 10 minuti sa 30 minuta wara li ngħatat id-doża.
English: 95% CI *One subject had missing data at 8 AM at Week 6; one had missing data at 4 PM at Month 3.
Maltese: CI ta' 95% (-8.6, -7.9) *Individwu wieħed kellu dejta nieqsa f'8 AM f'Ġimgħa 6; wieħed kellu dejta nieqsa f'4 PM f'Xahar 3.
English: Table 1 Travoprost 30 µg/mL eye drops, solution
Maltese: Tabella 1 Travoprost 30 µg/mL qtar għall-għajnejn, soluzzjoni
English: This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Maltese: Dan jista' jnaqqas l-assorbiment sistemiku tal-prodotti mediċinali mogħtija fl-għajn u jirriżulta fi tnaqqis tar-reazzjonijiet avversi sistemiċi.
English: The efficacy of TRAVATAN (travoprost 40 micrograms/mL eye drops, solution) in paediatric patients from 2 months to less than 18 years of age was demonstrated in a 12-week, double-masked clinical study of travoprost compared with timolol in 152 patients diagnosed with ocular hypertension or paediatric glaucoma.
Maltese: L-effikaċja ta' TRAVATAN (travoprost 40 mikrogramma/mL qtar għall-għajnejn, soluzzjoni) f'pazjenti pedjatriċi li għandhom inqas minn xahrejn sa 18-il sena kienet murija fi studju kliniku ta' 12-il ġimgħa, double-masked ta' travoprost meta mqabbel ma' timolol f'152 pazjent dijanjostikati bi pressjoni għolja fl-għajn jew glawkoma pedjatrika.
English: In a clinical trial, patients with open-angle glaucoma or ocular hypertension treated with IZBA dosed once-daily in the evening, demonstrated intraocular pressure lowering equivalent to travoprost 40 µg/mL eye drops, solution at all on-therapy visits and time points (95% CI within ±1.0 mmHg).
Maltese: Fi prova klinika, pazjenti bi glawkoma open angle jew pressjoni għolja fl-għajn ikkurati b'IZBA iddożat darba kuljum filgħaxija, urew tnaqqis fil-pressjoni ta' ġewwa l-għajn ekwivalenti għal travoprost 40 µg/mL qtar għall-għajnejn, soluzzjoni, fil-visti kollha ta' waqt it-terapija u fil-punti ta' żmien (CI ta' 95% f'firxa ta' ±1.0 mmHg).
English: Tiny amounts of hydrochloric acid or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Maltese: Jiġu miżjuda ammonti żgħar ħafna ta' hydrochloric acid jew sodium hydroxide biex iżommu l-livelli tal-aċidità (livelli tal-pH) normali.
English: IZBA contains hydrogenated castor oil and propylene glycol which may cause skin reactions and irritation.
Maltese: IZBA fih hydrogenated castor oil u propylene glycol li jistgħu jikkawżaw reazzjonijiet u irritazzjoni fil-ġilda.
English: Rare iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis meibomianitis, anterior chamber pigmentation, mydriasis, asthenopia, eyelash hyperpigmentation, eyelash thickening
Maltese: Rari iridoċiklite, herpes simplex fl-għajnejn, infjammazzjoni tal-għajnejn, fotopsija, ekżema tal-kappell tal-għajn, edima fil-konġuntiva, vista b'awreola, follikuli fil-konġuntiva, ipoestesija tal-għajn, trichiasis meibomianitis, pigmentazzjoni tal-kompartiment anterjuri, midrijasi, astenopija, iperpigmentazzjoni taxxagħar tal-għajnejn, tħaxxin tax-xagħar tal għajnejn
English: The safety and efficacy of travoprost have not been established in this age group.
Maltese: Is-sigurtà u leffikaċja ta' travoprost għadhom ma ġewx stabbiliti f'dan il-grupp ta' età.
English: Uncommon side effects: may affect up to 1 in 100 people
Maltese: Effetti sekondarji mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100
English: One mL of solution contains 30 micrograms of travoprost.
Maltese: Kull mL ta' soluzzjoni fiha 30 mikrogramma ta' travoprost.
English: Each 4 mL bottle will contain 2.5 mL of solution.
Maltese: Kull flixkun ta' 4 mL se jkun fih 2.5 mL ta' soluzzjoni.
English: Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1).
Maltese: Tnaqqis ta' pressjoni għolja fl-għajnejn f'pazjenti adulti bi pressjoni għolja tal-għajnejn jew glawkoma tat-tip open-angle (ara sezzjoni 5.1).
English: IZBA 30 micrograms/mL eye drops, solution travoprost
Maltese: IZBA 30 mikrogramma/mL qtar għall-għajnejn, soluzzjoni travoprost
English: IZBA contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
Maltese: IZBA fih polyoxyethylene hydrogenated castor oil 40 li jista' jikkawża reazzjonijiet fil-ġilda.
English: Other medicines and IZBA
Maltese: Mediċini oħra u IZBA
English: Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin.
Maltese: Prostaglandins u analogi ta' prostaglandin huma materjali attivi bijoloġikament li jistgħu jiġu assorbiti mill-ġilda.
English: In a clinical trial of 3 months duration (N=442) involving IZBA as monotherapy, the most common adverse reaction observed was hyperaemia of the eye (ocular or conjunctival) reported in approximately 12% of the patients.
Maltese: Fi prova klinika li damet 3 xhur (N=442) li kienet tinvolvi IZBA bħala monoterapija, l-aktar reazzjoni avversa komuni osservata kienet iperimija tal-għajn (okulari jew tal-konġuntiva) irrappurtata f'madwar 12% tal-pazjenti.
English: Date of first authorisation: 20 February 2014 Date of latest renewal:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Frar 2014
English: A topical overdose is not likely to occur or to be associated with toxicity.
Maltese: Doża topika eċċessiva mhux probabbli li sseħħ jew li tkun assoċjata ma' tossiċità.
English: Travoprost 40 µg/mL eye drops, solution preserved with polyquaternium-1 induced minimal ocular surface toxicity, compared to eye drops preserved with benzalkonium chloride, on cultured human corneal cells and following topical ocular administration in rabbits.
Maltese: Travoprost 40 µg/mL qtar għall-għajnejn, soluzzjoni, ippreservat b'polyquaternium-1 ikkawża tossiċità minima fis-superfiċje tal-għajn, meta mqabbel ma' qtar għall-għajnejn ippreservat b'benzalkonium chloride, f'kolturi ta' ċelluli tal-kornea umana u wara għoti topika fl-għajn fil-fniek.
English: IZBA is packaged in a 4 mL syndiotactic polypropylene (sPP) oval bottle with polypropylene (PP) dispensing plugs and closures presented in an overwrap.
Maltese: IZBA huwa ppakkjat fi flixkun ovali ta' 4 mL magħmul minn syndiotactic polypropylene (sPP) b'tappijiet għall-għoti u għall-għeluq magħmula minn polypropylene (PP) ippreżentat f'kisja ta' protezzjoni.
English: There are no data on the effects of travoprost on human fertility.
Maltese: M'hemmx dejta dwar l-effetti ta' travoprost fuq il-fertilità tal-bniedem.
English: CARTON FOR SINGLE BOTTLE 4.0 mL + CARTON FOR 3 x 4.0 mL BOTTLES
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA GĦALL-FLIXKUN WIEĦED 4.0 mL + KARTUNA GĦAL 3 FLIXKEN x 4.0 mL
English: IOP reductions for this group were based on only 6 patients in the timolol group and 9 patients in the travoprost group where 4 patients in the travoprost group versus 0 patients in the timolol group had no relevant mean IOP reduction at Week 12.
Maltese: It-tnaqqis ta' IOP għal dan il-grupp kien ibbażat fuq 6 pazjenti biss fil-grupp ta' timolol u 9 pazjenti fil-grupp ta' travoprost fejn 4 pazjenti fil-grupp ta' travoprost meta mqabbel ma' 0 pazjent fil-grupp ta' timolol ma kellhom l-ebda tnaqqis medju rilevanti fl-IOP f'Ġimgħa 12.
English: Reproduction and development studies have demonstrated a potent effect on foetal loss with a high rate observed in rats and mice (180 pg/mL and 30 pg/mL plasma, respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/mL).
Maltese: Studji dwar l-effett fuq is-sistema riproduttiva u l-iżvilupp urew effett qawwi fuq it-telf tal-fetu, b'rata għolja osservata filfirien u l-ġrieden (180 pg/mL u 30 pg/mL fil-plażma, rispettivament) f'esponimenti ta' 1.2 sa 6 darbiet l-esponiment kliniku (sa 25 pg/mL).
English: Unilateral treatment can result in permanent heterochromia.
Maltese: Kura f'għajn waħda tista' twassal għal eterokromja permanenti.
English: IZBA may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes.
Maltese: B'mod gradwali IZBA jista' jbiddel il-kulur tal-għajn billi jżid in-numru ta' melanosomi (grani talpigment) fil-melanoċiti.
English: Following topical ocular administration of travoprost 40 µg/mL eye drops, solution to healthy volunteers, low systemic exposure to active free acid was demonstrated.
Maltese: Wara għoti topiku fl-għajn ta' travoprost 40 µg/mL qtar għall-għajnejn, soluzzjoni, lill-voluntiera f'saħħithom, kien dimostrat esponiment sistemiku baxx għall-aċidu ħieles attiv.
English: Week 6
Maltese: Dublin 4
English: An improved safety profile has been observed for IZBA when compared to the marketed travoprost 40 µg/mL eye drops, solution (benzalkonium chloride preserved or polyquaternium-1 perserved).
Maltese: Kien osservat profil ta' sigurtà mtejjeb għal IZBA meta mqabbel ma' travoprost 40 µg/mL qtar għallgħajnejn, soluzzjoni, (ippreservat b'benzalkonium chloride jew ippreservat b'polyquaternium-1) imqiegħed fis-suq.
English: Uncommon cough, nasal congestion, throat irritation
Maltese: Mhux Komuni sogħla, konġestjoni fl-imnieħer, irritazzjoni filgriżmejn
English: Decrease of elevated intraocular pressure in paediatric patients aged 3 years to <18 years with ocular hypertension or paediatric glaucoma (see section 5.1).
Maltese: Tnaqqis ta' pressjoni għolja fl-għajnejn f'pazjenti pedjatriċi b'età ta' 3 snin sa <18-il sena bi pressjoni għolja fl-għajnejn jew glawkoma pedjatrika (ara sezzjoni 5.1).
English: Table 4 Comparison of Mean IOP Change from Baseline (mmHg) at Week 12
Maltese: Tabella 4 - Tqabbil tal-Bidla Medja fl-IOP mil-Linja Bażi (mmHg) f'Ġimgħa 12
English: It is absorbed through the cornea where the isopropyl ester is hydrolysed to the active free acid.
Maltese: Jiġi assorbit mill-kornea fejn l-isopropyl ester jiġi idrolizzat għallaċidu ħieles attiv.
English: Visit
Maltese: Vista
English: IZBA can be used in children from 3 years to <18 years at the same dose as for adults.
Maltese: IZBA jista' jintuża fit-tfal minn 3 snin sa <18-il sena bl-istess doża bħall-adulti.
English: Uncommon corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, eye discharge, blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus, visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes
Maltese: Mhux Komuni tħaffir tal-kornea, uveite, irite, infjammazzjoni tal-kompartiment anterjuri, keratite, keratite ttikkjata, fotofobija, tnixxija mill-għajn, blefarite, eritema tal-kappell tal-għajn, edima madwar lgħajn, ħakk fil-kappell tal-għajn, akutezza talvista mnaqqsa, vista mċajpra, żieda fid-dmugħ, konġuntivite, ektropjon, katarretti, qoxra fit-tarf tal-kappell tal-għajn, tkabbir tax-xagħar talgħajnejn
English: In children and adolescents, the most common side effects seen with the medicine containing a higher strength of travoprost (40 micrograms/mL) are eye redness and growth of eyelashes.
Maltese: Fit-tfal u l-adolexxenti, l-effetti sekondarji l-aktar komuni osservati bil-mediċina li jkun fih qawwa ogħla ta' travoprost (40 mikrogramma/mL) huma ħmura fl-għajnejn u t-tkabbir ta' xagħar talgħajnejn.
English: 1 mL of solution contains 30 micrograms of travoprost
Maltese: Kull mL ta' soluzzjoni fih 30 mikrogramma ta' travoprost
English: General side effects: eye viral infection, dizziness, bad taste, irregular or decreased heart rate, increased or decreased blood pressure, shortness of breath, asthma, nasal allergy or inflammation, nasal dryness, voice changes, gastrointestinal discomfort or ulcer, constipation, dry mouth, redness or itching of the skin, rash, hair colour change, loss of eyelashes, joint pain, musculoskeletal pain, generalised weakness.
Maltese: Effetti sekondarji ġenerali: infezzjoni fl-għajn ikkawżata minn virus, sturdament, togħma ħażina, rata tal-qalb irregolari jew imnaqqsa, żieda jew tnaqqis fil-pressjoni tad-demm, qtugħ ta' nifs, ażżma, allerġija jew infjammazzjoni tal-imnieħer, imnieħer jinħass xott, bidliet fil-vuċi, tax-xagħar talgħajnejn jew ulċera gastrointestinali, stitikezza, ħalq xott, ħmura jew ħakk tal-ġilda, raxx, bidla filkulur tax-xagħar, telf tax-xagħar tal-għajnejn, uġigħ fil-ġogi, uġigħ muskoluskeletriku, dgħjufija ġeneralizzata.
English: Both side effects were observed with a higher incidence in children and adolescents compared to adults.
Maltese: Iż-żewġ effetti sekondarji kienu osservati b'inċidenza ogħla fi tfal u adolexxenti meta mqabbel mal-adulti.
English: IZBA has not been specifically studied in a clinical trial involving paediatric subjects.
Maltese: IZBA ma ġiex studjat speċifikament fi prova klinika li tinvolvi individwi pedjatriċi.
English: Periorbital and eye lid changes
Maltese: .8 Effetti mhux mixtieqa
English: Travoprost, a prostaglandin F2 analogue, is a highly selective full agonist which has a high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways.
Maltese: Travoprost, analogu ta' prostaglandin F2α, huwa agonist komplut selettiv ħafna li għandu affinita għolja għar-riċettur FP ta' prostaglandin u jnaqqas il-pressjoni fl-għajn billi jżid il-ħruġ tal-aqueous humour mix-xibka trabekulari u r-rotot uveosklerali.
English: However, a modelling approach demonstrated that IOP lowering would be expected to be equivalent in paediatric patients aged 3 years and above using both IZBA and TRAVATAN (travoprost 40 micrograms/mL eye drops, solution).
Maltese: Madankollu, approċċ ta' mmudellar wera li tnaqqis tal-IOP ikun mistenni li jkun ekwivalenti f'pazjenti pedjatriċi li għandhom 3 snin u iktar bl-użu kemm ta' IZBA kif ukoll ta' TRAVATAN (travoprost 40 mikrogramma/mL qtar għall-għajnejn, soluzzjoni).
English: IZBA contains propylene glycol which may cause skin irritation.
Maltese: IZBA fih propylene glycol li jista' jikkawża irritazzjoni fil-ġilda.
English: IZBA can be used in paediatric patients from 3 years to <18 years at the same posology as in adults (see section 5.1).
Maltese: IZBA jista' jintuża f'pazjenti pedjatriċi li għandhom minn 3 snin sa <18-il sena bl-istess pożoloġija bħall-adulti (ara sezzjoni 5.1).
English: In pregnant rat, systemic administration of travoprost at doses more than 200 times the clinical dose during the period of organogenesis resulted in an increased incidence of malformations.
Maltese: F'firien tqal, l-għoti sistemiku ta' travoprost f'dożi aktar minn 200 darba d-doża klinika, waqt il-perjodu tal-organoġenesi wassal għal żieda fl-inċidenza ta' malformazzjonijiet.
English: Do not use this medicine after the expiry date which is stated on the bottle and the box after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-flixkun u l-kaxxa wara ‘EXP'.
English: Currently available data are described in section 5.1 but no recommendation on a posology below the age of 3 years can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 5.1 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija taħt l-eta ta' 3 snin.
English: • IZBA may increase the length, thickness, colour and/or number of your eyelashes.
Maltese: • IZBA jista' jżid it-tul, il-ħxuna, il-kulur u/jew in-numru ta' xagħar tal-għajnejn.
English: Contact lenses
Maltese: Lentijiet tal-kuntatt