FrancophonIA/ELRC3.0 huggingface dataset:
English: This may result in a decrease in systemic side effects and an increase in local activity.
Maltese: Dan jista' jirriżulta fi tnaqqis tal-effetti sistemiċi sekondarji u f'żieda fl-attività lokali.
English: The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 1/hr/kg.
Maltese: Il-half-life ta' l-eliminazzjoni, wara l-għoti ġol-vina, kienet ta' madwar 45 minuta; it-tneħħija totali mid-demm kienet ta' 1.5 l/siegħa/kg.
English: In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery.
Maltese: Barra minn hekk, sinjali u sintomi ta' imblokk beta (pereżempju bradikardija, pressjoni baxxa, diffikultajiet respiratorji u ipogliċemija) kienu osservati fi trabi tat-twelid meta imblokkaturi tar-riċetturi beta ngħataw sal-ħlas.
English: GANFORT single-dose has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure, congenital or narrow-angle glaucoma.
Maltese: GANFORT ma kienx studjat f'pazjenti b'kundizzjonijiet infjammatorji fl-għajn, neovaskolari, infjammatorji, angle-closure glawkoma, glawkoma konġenitali jew narrow-angle glawkoma.
English: Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP at all follow up timepoints throughout the study (p < 0.001).
Maltese: Iż-żewġ gruppi ta' kura wrew tnaqqis medju mil-linja bażi li kien statistikament u klinikament sinifikanti fl-IOP fl-agħar għajn fil-punti kollha ta' żmien tal-follow-up matul l-istudju (p < 0.001).
English: Pharmacotherapeutic group: Ophthalmological, beta-blocking agents - ATC code: S01ED51.
Maltese: Oftalmoloġiku, sustanzi ta' imblokkaturi beta - Kodiċi ATC:
English: • Red scaly patches on skin; skin rash
Maltese: • Irqajja' ħomor u li jitqaxxru fuq il-ġilda; raxx tal-ġilda
English: Macular oedema, including cystoid macular oedema has been reported with GANFORT (multi-dose formulation).
Maltese: Edima makulari, li tinkludi edima makulari taċ-ċistojde kienet irrappurtata wara kura b'GANFORT (formulazzjoni b'ħafna dożi).
English: Not known hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy
Maltese: Mhux magħrufa reazzjonijiet ta' sensittività eċċessiva li jinkludu sinjali jew sintomi ta' dermatite allerġika, anġjoedema, allerġija flgħajnejn
English: No new adverse reactions specific for GANFORT have been observed in clinical studies.
Maltese: L-ebda reazzjonijiet avversi ġodda speċifiċi għal GANFORT ma ġew osservati fl-istudji kliniċi.
English: • Fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
Maltese: • Iħossok ħażin; tnaqqis tal-fluss tad-demm lill-moħħ; aggravament ta' mijastenija gravis (żieda tad-dgħufija fil-muskoli); sensazzjoni ta' tnemnim
English: GANFORT consists of two active substances: bimatoprost and timolol.
Maltese: GANFORT jikkonsisti f'żewġ sustanzi attivi: bimatoprost u timolol.
English: After ocular administration of a 0.5% eye drops solution in humans undergoing cataract surgery, peak timolol concentration was 898 ng/ml in the aqueous humour at one hour post-dose.
Maltese: Wara li jitqattar qtar ta' 0.5% fl-għajn f'persuni li għaddew minn operazzjoni tal-katarretti, l-ogħla konċentrazzjoni ta' timolol kienet ta' 898 ng/ml fl-aqueous humour siegħa wara d-doża.
English: If you use GANFORT single-dose with another eye medicine, leave at least 5 minutes between putting in GANFORT single-dose and the other medicine.
Maltese: Jekk tuża GANFORT flimkien ma' mediċina oħra ta' l-għajnejn, ħalli mill-anqas 5 minuti bejn l-użu ta' GANFORT u l-mediċina l-oħra.
English: In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost had no adverse reactions on liver function over 24 months.
Maltese: F'pazjenti bi storja medika kellhom mard tal-fwied ħafif jew anormalità fl-alanine aminotransferase (ALT), aspartate aminotransferase (AST) u/jew bilirubin fil-linja bażi, bimatoprost qtar tal-għajnejn ma kellu l-ebda reazzjonijiet avversi fuq il-funzjoni tal-fwied fuq perjodu ta' 24 xahar.
English: White opaque low-density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml.
Maltese: Fliexken bojod u opaki ta' polyethylene ta' densità baxxa b'għatu bil-kamini tal-polystyrene.
English: Breast-feedingTimolol
Maltese: TAL-PRODOTT MEDIĊINALI
English: Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
Maltese: Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, hydrochloric acid jew sodium hydroxide (biex jaġġusta l-pH) u ilma ppurifikat.
English: GANFORT has not been studied in patients with hepatic or renal impairment.
Maltese: GANFORT ma kienx studjat f'pazjenti b'indeboliment epatiku jew renali.
English: Common punctuate keratitis, corneal erosion2, burning sensation2, conjunctival irritation1, eye pruritus, stinging sensation in the eye2, foreign body sensation, dry eye, erythema of eyelid, eye pain, photophobia, eye discharge2, visual disturbance2, eyelid pruritus, visual acuity worsened2, blepharitis2, eyelid oedema, eye irritation, lacrimation increased, growth of eyelashes.
Maltese: Jaffettwaw l-għajnejn ħruq, ħakk, tingiż, irritazzjoni tal-konġuntiva (is-saff trasparenti tal-għajn), sensittività għad-dawl, uġigħ fl-għajnejn, għajnejn iwaħħlu, għajnejn xotti, sensazzjoni li hemm xi ħaġa fl-għajn, tiċrit żgħir fil-wiċċ tal-għajn bi jew mingħajr infjammazzjoni, diffikultà biex tara ċar, ħmura u ħakk ta' tebqet ilgħajn, xagħar li jikber madwar l-għajn, kulur skur ta' tebqet il-għajn, kulur iktar skur madwar lgħajnejn, xagħar tal-għajnejn itwal, irritazzjoni fl-għajnejn, għajnejn idemmgħu, tebqet il-għajnejn minfuħin, vista mnaqqsa.
English: No enhancement of the systemic absorption of the individual active substances has been observed with GANFORT (multi-dose formulation).
Maltese: L-ebda titjib tal assorbiment sistemiku tas-sustanzi attivi individwali ma kien osservat b'GANFORT (formulazzjoni b'ħafna dożi).
English: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline.
Maltese: Preparazzjonijiet oftalmoloġiċi beta li jimblokkaw jistgħu jimblokkaw l-effetti sistemiċi ta' betaagonist, eż. tal-adrenalina.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POUCH CONTAINING STRIP OF 10 SINGLE-DOSE CONTAINERS
Maltese: BORŻA LI FIHA STRIXXA TA' 10 KONTENITURI TA' DOŻA WAĦDA
English: Paediatric population The safety and efficacy of GANFORT in children aged 0 to 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' GANFORT fit-tfal min età ta' 0 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 1/kg.
Maltese: Bimatoprost jitqassam b'mod moderat fit-tessuti tal-ġisem u l-volum ta' distribuzzjoni sistemika flistat fiss fin-nies hu ta' 0.67 l/kg.
English: Tel.: +48 22 256 3700
Maltese: Allergan Sp.z o.o. Tel.: +48 22 256 3700
English: Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Maltese: Midrijasi li tirriżulta mill-użu fl-istess ħin ta' imblokkaturi beta oftalmiċi u adrenaline (epinephrine)
English: Like other topically applied ophthalmic medicinal products, the active substances (timolol/ bimatoprost) in GANFORT single-dose may be absorbed systemically.
Maltese: Bħal prodotti mediċinali oħra li jiġu applikati b'mod topiku fl-għajn, is-sustanzi attivi (timolol/ bimatoprost) f'GANFORT jistgħu jiġu assorbiti b'mod sistemiku.
English: A total of 56 cases have been derived from EudraVigilance for ophthalmic timolol products including 5 for the bimatoprost/timolol combination product which have given rise to various “Perception disturbances” like: Hallucination; Derealisation; Hallucination, auditory; Hallucination, visual.
Maltese: Total ta' 56 każ ġew derivati mill-EudraVigilance għall-prodotti oftalmiċi li fihom timolol inklużi 5 għall-prodott ikkombinat bimatoprost/timolol li wasslu għal diversi “Disturbi fil-perċezzjoni” bħal:
English: GANFORT single-dose achieved noninferior IOP-lowering efficacy to GANFORT (multi-dose formulation): the upper limit of the 95% CI of the between-treatment difference was within the pre-defined 1.5 mm Hg margin at each timepoint evaluated (hours 0, 2, and 8) at week 12 (for the primary analysis), and also at weeks 2 and 6, for mean worse eye IOP change from baseline (worse eye IOP refers to the eye with the higher mean diurnal IOP at baseline).
Maltese: Hg f'kull punt ta' żmien li ġie evalwat (sigħat 0, 2, u 8) f'ġimgħa 12 (għall-analiżi primarja), u wkoll f'ġimgħat 2 u 6, għall-bidla medja mil-linja bażi tal-IOP fl-agħar għajn (IOP tal-agħar għajn tirreferi għall-għajn bl-ogħla IOP medja matul il-jum fil-linja bażi).
English: This may cause similar side effects as seen with ”intravenous” and /or “oral” beta-blocking agents.
Maltese: Dan jista' jikkawża effetti sekondarji simili bħal dawk osservati b'sustanzi mblokkaturi beta “użati fil-vina” u/jew “orali”.
English: Absorption of timolol may cause similar undesirable effects as seen with systemic beta-blocking agents.
Maltese: L-assorbiment ta' timolol jista' jikkawża effetti mhux mixtieqa simili bħal dawk osservati meta jintużaw mediċini beta-blocking sistemiċi.
English: Pack contains 1 foil pouch containing 5 single-dose containers in a carton.
Maltese: Kull borża fiha 10 kontenituri b'doża waħda.
English: Packs contain 3 or 9 foil pouches, each containing 10 single-dose containers, for a total of 30 or 90 single-dose containers in a carton, respectively.
Maltese: Il-pakketti fihom 3 jew 9 boroż tal-fojl, b'kull waħda fiha 10 kontenituri b'doża waħda, għal total ta' 30 jew 90 kontenitur b'doża waħda f'kartuna, rispettivament.
English: Studies in rodents produced species-specific abortion at systemic exposure levels 33- to 97-times that achieved in humans after ocular administration.
Maltese: Studji f'annimali gerriema pproduċew assorbiment speċifiku għall-ispeċi f'livelli ta' 33 sa 97 darba aktar minn dak li ntlaħaq fil-bnedmin wara li ngħata fl-għajnejn.
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Contents of the pack and other information What GANFORT contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih GANFORT doża waħda
English: 5 How to store GANFORT Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: GANFORT contains two different active substances (bimatoprost and timolol) that both reduce pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, a prostaglandin analogue.
Maltese: GANFORT fih żewġ sustanzi attivi differenti (bimatoprost u timolol) u t-tnejn li huma jnaqqsu l-pressjoni għolja fil-għajn.
English: Timolol is partially metabolised by the liver with timolol and its metabolites excreted by the kidney.
Maltese: Timolol jiġi metabolizzat parzjalment mill fwied u timolol u l-metaboliti tiegħu jiġu mneħħija mill-kliewi.
English: Timolol lowers IOP by reducing aqueous humour formation.
Maltese: Timolol ma jintrabatx b'mod estensiv mal-plażma.
English: PC SN: NN:
Maltese: PC:
English: Eye drops, solution 90 x 0.4 ml
Maltese: 90 x 0.4 ml
English: One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate)
Maltese: 1 ml ta' soluzzjoni fih 0.3 mg ta' bimatoprost u 5 mg timolol (bħala 6.8 mg ta' timolol maleate)
English: One ml of solution contains 0.3 mg bimatoprost and 5 mg timolol (as 6.8 mg of timolol maleate).
Maltese: 1 ml ta' soluzzjoni fih 0.3 mg ta' bimatoprost u 5 mg timolol (bħala 6.8 mg ta' timolol maleate).
English: Clear, single-dose low density polyethylene (LDPE) containers with a twist-off tab.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kontenituri trasparenti, b'doża waħda, magħmula minn polyethylene ta' densità baxxa (LDPE - low density polyethylene) b'tarf li jista' jitqaċċat billi ddawwar.
English: Monkeys administered ocular bimatoprost concentrations of ≥0.03% daily for 1 year had an increase in iris pigmentation and reversible dose-related periocular effects characterised by a prominent upper and/or lower sulcus and widening of the palpebral fissure.
Maltese: 03% ta' bimatoprost ingħatat kuljum fl-għajnejn tax-xadini, irriżultat f'żieda fil-pigmentazzjoni tal-ħabba tal-għajn u effetti periokulari marbuta mad-doża li huma riversibbli u karatterizzati minn sulcus promininenti fuq u/jew isfel u twessigħ tal-fissura palpebrali.
English: GANFORT is a colourless to slightly yellow, clear eye drop solution in a plastic bottle.
Maltese: GANFORT hu soluzzjoni ta' qtar għall-għajnejn, ċara sa ftit safra, mingħajr kulur li tinsab fi flixkun tal-plastik.
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution
Maltese: GANFORT 0.3 mg/ml + 5 mg/ml qtar għall-għajnejn, soluzzjoni
English: GANFORT single-dose consists of two active substances: bimatoprost and timolol.
Maltese: GANFORT doża waħda jikkonsisti f'żewġ sustanzi attivi: bimatoprost u timolol.
English: Common blepharal pigmentation2, hirsutism2, skin hyperpigmentation (periocular).
Maltese: blefarospażmu2, emorraġija tar-retina2, uveite2,
English: The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml.
Maltese: Id-daqsijiet li ġejjin tal-pakketti huma disponibbli: kaxxi li jkun fihom 1 jew 3 fliexken ta' 3 ml.
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution bimatoprost/timolol
Maltese: GANFORT 0.3 mg/ml + 5 mg/ml qtar għall-għajnejn, soluzzjoni bimatoprost/timolol
English: Uncommon iritis2, conjunctival oedema2, eyelid pain2, abnormal sensation in the eye1, asthenopia, trichiasis2, iris hyperpigmentation2, deepening of eyelid sulcus, eyelid retraction2, eyelash discolouration (darkening)1.
Maltese: sensazzjoni anormali fl-għajn1, astenopja, trikijasi2, iperpigmentazzjoni tal-parti kkulurita tal-għajn2, is-sulkus ta' tebqet il-għajn isir iktar fond,
English: However, consideration should be given to the likelihood of compliance when considering either morning or evening dosing (see section 5.1).
Maltese: Madankollu, trid tingħata konsiderazzjoni għallpossibbiltà ta' konformità meta tikkunsidra jew dożaġġ filgħodu jew filgħaxija (ara sezzjoni 5.1).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS (PROVIDED IN 3 POUCHES, EACH CONTAINING 10 SINGLE-DOSE CONTAINERS)
Maltese: KARTUNA LI FIHA 30 KONTENITUR B'DOŻA WAĦDA (IPPROVDUTI
English: GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container bimatoprost/timolol
Maltese: GANFORT 0.3 mg/ml + 5 mg/ml, qtar għall-għajnejn, soluzzjoni, f'kontenitur b'doża waħda bimatoprost/timolol
English: Vascular disorders hypotension1, hypertension2, Raynaud's phenomenon1, cold hands and feet1
Maltese: Disturbi vaskulari pressjoni baxxa1, pressjoni għolja2, il-fenomenu ta' Raynaud1, idejn u saqajn kesħin1
English: Respiratory, thoracic and mediastinal disorders Asthma exacerbation2, COPD exacerbation2, cough1
Maltese: sensazzjoni mhux normali fl għajn1, astenopija, trikijażi2,
English: Taking into account the PRAC Assessment Report on the PSUR(s) for bimatoprost / timolol, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal bimatoprost / timolol, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: heart failure, low blood pressure - disturbances of heart rate such as slow heart beat - breathing problems, asthma or chronic obstructive pulmonary disease - poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome) - overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease - diabetes as timolol may mask signs and symptoms of low blood sugar - severe allergic reaction - liver or kidney problems - eye surface problems - separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye - known risk factors for macular oedema (swelling of the retina within the eye leading to worsening vision), for example, cataract surgery
Maltese: Tużax GANFORT qtar għall-għajnejn, soluzzjoni - jekk int allerġiku għal bimatoprost, timolol, imblokkaturi beta jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6). - jekk għandek jew kellek fil-passat problemi respiratorji bħal ażżma, bronkite ostruttiva kronika severa (mard sever tal-pulmun li jista' jikkawża tħarħir, diffikultà biex tieħu n-nifs u/jew sogħla li ddum fit-tul) - jekk għandek problemi tal-qalb bħal rata baxxa ta' taħbit tal-qalb, imblokk tal-qalb, jew insuffiċjenza tal-qalb
English: Carton containing 30 or 90 single-dose containers in three or nine aluminium foil pouches respectively.
Maltese: Kartuna li jkun fiha 30 jew 90 kontenitur b'doża waħda fi tliet jew disa' boroż tal-fojl tal-aluminju rispettivament.
English: Based on a 12-week study of GANFORT single-dose administered once daily, the most commonly reported adverse reaction with GANFORT single-dose was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 21% of patients and led to discontinuation in 1.4% of patients.
Maltese: Ibbażat fuq tagħrif kliniku ta' 12-il xahar, l-iktar reazzjoni avversa li kienet irrappurtata kienet iperimija konġuntivali (il-biċċa l-kbira minn traċċa sa ħafifa u maħsuba li hi ta' natura mhux infjammatorja) f'madwar 26% talpazjenti u wasslet għal waqfien tal-kura f'1.5% tal-pazjenti.
English: It is known that ophthalmic beta-blockers (like e.g. timolol) in some cases can cause systemic side effects.
Maltese: Huwa magħruf li f'xi każijiet, imblokatturi tar-riċettur beta oftalmiċi (bħal eż. timolol) jistgħu jikkawżaw effetti sekondarji sistemiċi.
English: After 12 months treatment with GANFORT, the incidence of iris pigmentation was 0.2%.
Maltese: Wara 12-il xahar ta' kura b'GANFORT, l-inċidenza tal-pigmentazzjoni tal-ħabba tal-għajn kienet ta' 0.2%.
English: Eye drops, solution.
Maltese: Alluċinazzjoni, viżiva.
English: Eye drops, solution 5 x 0.4 ml
Maltese: 5 x 0.4 ml
English: Uncommon dyspnoea
Maltese: Reazzjoni avversa
English: - disturbances of heart rate such as slow heart beat - breathing problems, asthma or chronic obstructive pulmonary disease - poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome) - overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease - diabetes as timolol may mask signs and symptoms of low blood sugar - severe allergic reactions - liver or kidney problems - eye surface problems - separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye - known risk factors for macular oedema (swelling of the retina within the eye leading to worsening vision), for example, cataract surgery
Maltese: • Tnaqqis fis-sens tal-mess fuq il-wiċċ tal-għajn; tara doppju; tebqet il-għajn li tiddendel; separazzjoni ta' waħda mis-saffi ġol-għajn wara operazzjoni biex tnaqqas il-pressjoni ġolgħajn; infjammazzjoni tal-wiċċ tal-għajn, ħruġ ta' demm fuq in-naħa ta' wara tal-għajn (ħruġ ta' demm fir-retina), infjammazzjoni ġol-għajn, żieda fit-teptip tal-għajn
English: No specific interaction studies have been performed with the bimatoprost / timolol fixed combination.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni bil-kombinazzjoni fissa ta' bimatoprost/timolol.
English: • The other ingredients are benzalkonium chloride (a preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water.
Maltese: • Is-sustanzi mhux attivi l-oħra huma sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate u ilma ppurifikat.
English: Therefore, GANFORT single-dose should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
Maltese: Għalhekk, GANFORT doża waħda għandu jintuża b'attenzjoni f'pazjenti afakiċi, f'pazjenti psewdoafakiċi b'tiċrita fil-kapsula tal-lenti posterjuri, jew f'pazjenti b'fatturi ta' riskju magħrufa għal edima makulari (eż. operazzjoni fl-għajnejn, okklużjonijiet fil-vina tar-retina, mard infjammatorju tal-għajnejn u retinopatija dijabetika).
English: Fertility There are no data on the effects of GANFORT single-dose on human fertility.
Maltese: Fertilità M'hemm l-ebda dejta klinika dwar l-effett ta' GANFORT fuq il-fertilità tal-bniedem.
English: • Diarrhoea; stomach pain; feeling and being sick; indigestion; dry mouth
Maltese: • Uġigħ fil-muskoli • Tnaqqis fl-aptit sesswali; disfunzjoni sesswali
English: Benzalkonium chloride may cause eye irritation and is also known to discolour soft contact lenses.
Maltese: Benzalkonium chloride jista' jikkawża irritazzjoni fl-għajnejn u huwa magħruf ukoll li jibdel il-kulur ta' lentijiet tal-kuntatt rotob.
English: The adverse reactions reported in the clinical study using GANFORT single-dose were limited to those earlier reported for either GANFORT (multi-dose formulation) or for the single active substances bimatoprost or timolol.
Maltese: Din l-ADR (adverse drug reaction - reazzjoni avversa għall-mediċina) x'aktarx hija marbuta massustanza attiva bimatoprost, u mhux mal-preservattiv.
English: Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pace-maker.
Maltese: Bradikardija tas-sinus, sindrome tas-sinus marid, imblokk sinoatrijali, ostaklu atrijoventikulari tat-tieni jew tat-tielet grad mhux ikkontrollat b'pacemaker.
English: Hydrochloric acid or sodium hydroxide (to adjust pH) Purified water
Maltese: Hydrochloric acid jew sodium hydroxide (biex ikun aġġustat il-livell ta' pH) Ilma ppurifikat
English: Eye drops, solution 30 x 0.4 ml
Maltese: 30 x 0.4 ml
English: Timolol belongs to a group of medicines called beta-blockers.
Maltese: Timolol jifforma parti minn grupp ta' mediċini magħrufa bħala imblokkaturi tar-riċetturi beta.
English: These may affect 1 to 9 users in 100
Maltese: Dawn jistgħu jaffettwaw minn 1 sa 9 utenti minn kull 100
English: How to store GANFORT
Maltese: X'fih GANFORT
English: Part of the dose is absorbed systemically where it is extensively metabolised in the liver.
Maltese: Parti middoża tkun assorbita sistemikament fejn tiġi metabolizzata mill-fwied b'mod estensiv.
English: These may affect 1 to 9 users in 1,000
Maltese: Dawn jistgħu jaffettwaw minn 1 sa 9 utenti minn kull 1,000
English: Therefore, GANFORT should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
Maltese: Għalhekk, GANFORT għandu jintuża b'attenzjoni f'pazjenti afakiċi, f'pazjenti psewdoafakiċi b'tiċrita fil-kapsula tal-lenti posterjuri, jew f'pazjenti b'fatturi ta' riskju magħrufa għal edima makulari (eż. operazzjoni fl-għajnejn, okklużjonijiet fil-vina tar-retina, mard infjammatorju tal-għajnejn u retinopatija dijabetika).
English: GANFORT has a rapid onset of action.
Maltese: GANFORT ma għandux jintuża minn nisa li qed ireddgħu.
English: 6.3 Shelf life
Maltese: Il-half-life ta'
English: Due to the beta-adrenergic component, timolol, the same types of cardiovascular, pulmonary and other adverse reactions (ADRs) as seen with systemic beta-blockers may occur.
Maltese: Minħabba l-komponent beta-adrenerġiku, timolol, l-istess tipi ta' reazzjonijiet avversi (ADRs - adverse reactions) kardjovaskulari, pulmonari u oħrajn bħal dawk osservati b'imblokkaturi beta sistemiċi jistgħu jseħħu.
English: CY-2234 Λευκωσία
Maltese: CY-2234