FrancophonIA/ELRC3.0 huggingface dataset:
English: At one year, pegaptanib 0.3 mg exhibited a statistically significant treatment benefit for the primary efficacy endpoint; proportion of patients losing less than 15 letters of visual acuity (prespecified pooled analysis, pegaptanib 0.3 mg 70% versus Sham 55%, p = 0.0001; EOP1003 pegaptanib 0.3 mg 73% versus Sham 59%, p = 0.0105; EOP1004 pegaptanib 0.3 mg 67% versus Sham 52%, p = 0.0031).
Maltese: Wara sena, pegaptanib 0.3 mg wera benefiċċju statistikament sinifikanti tal-kura għall-endpoint primarju ta' l-effikaċja; proporzjon tal-pazjenti li tilfu anqas minn 15-il ittra ta' akutezza viżwali (analiżi miġbura speċifikata minn qabel, pegaptanib 0.3 mg 70% kontra Sham 55%, p = 0.0001; EOP1003 pegaptanib 0.3 mg 73% kontra Sham 59%, p = 0.0105; EOP1004 pegaptanib 0.3 mg 67% kontra Sham 52%, p = 0.0031).
English: * Post-marketing experience; see “Description of selected adverse reactions”
Maltese: *Esperjenza Wara t-Tqegħid fis-Suq; ara “Deskrizzjoni ta' reazzjonijiet avversi magħżula”
English: Summary of Mean Changes in Visual Acuity from Baseline to Weeks 6, 12, 54 and 102 (LOCF) EOP 1004
Maltese: Sommarju tal-Bidliet Medji fl-Akutezza Viżwali mil-Linja Bażika sa Ġimgħa 6, 12, 54 u 102 (LOCF) EOP 1004
English: Sími frá útlöndum: +44 (0) 1748 828864
Maltese: Tel: +44 (0) 1748 828864
English: A total of 1190 patients were treated (892 pegaptanib, 298 sham (control)) with a median age of 77 years.
Maltese: Kienu kkurati b'kollox 1190 pazjent (892 pegaptanib, 298 sham (kontroll) b'eta' medjana ta' 77 sena.
English: • visual disturbance
Maltese: • disturb viżwali
English: • deformation of the pupil
Maltese: • deformazzjoni tal-pupilla
English: VEGF165 is the VEGF isoform preferentially involved in pathological ocular neovascularisation.
Maltese: VEGF165 hija l-iżoforma VEGF preferenzjalment involuta f'neovaskularizzazzjoni patoloġika ta' lgħajnejn.
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal aktar informazzjoni fuq l-użu pedjatriku.
English: Arterial thromboembolic events (ATEs) are adverse events potentially related to systemic VEGF inhibition.
Maltese: Avvenimenti tromboemboliċi arterjali (ATEs) huma avvenimenti avversi potenzjalment relatati mal-inibizzjoni sistemika ta' VEGF.
English: Patients had up to one prior PDT and baseline visual acuity in the study eye between 20/40 and 20/320.
Maltese: Il-pazjenti kellhom sa PDT waħda preċedenti u akutezza viżwali bażika fl-għajn studjata ta' bejn 20/40 u 20/320.
English: • optic nerve cupping
Maltese: • cupping tan-nerv ottiku
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose: 0.3 mg/90 µl
Maltese: Doża waħda: 0.3 mg/90 µl
English: The odds of increased IOP was increased by a factor of 1.128 for each additional injection (p= 0.0003).
Maltese: Il-possibbiltà ta' żieda fl-IOP żdiedet b'fattur ta' 1.128 għal kull injezzjoni addizzjonali (p=0.0003).
English: The adverse reactions are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati bis-sistema tal-klassifika ta' l-organi u l-frekwenza: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1000 sa <1/100), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)).
English: Tlf (fra udlandet): +46 8 616 95 85
Maltese: Fra utlandet Tlf: +46 8 616 95 85
English: sp. j. Tel.: +48 17 865 51 00
Maltese: Tel.: +48 17 865 51 00
English: Patients received a mean of between 8.4-8.6 treatments out of possible 9 total across all treatment arms in the first year.
Maltese: Il-pazjenti rċevew medja ta' 8.4-8.6 trattamenti minn total ta' 9 possibbli fil-gruppi kollha ta' kura fl-ewwel sena.
English: Pegaptanib sodium has not been adequately studied in patients with creatinine clearance below 20 ml/min.
Maltese: Pegaptanib sodium ma ġiex studjat b'mod adegwat f'pazjenti bi clearance tal-kreatinina taħt 20 ml/min.
English: The two trials enrolled patients, including all neovascular AMD lesion subtypes (25% predominantly classic, 39% occult with no classic and 36% minimally classic), lesion sizes up to 12 disc areas, of which up to 50% could be comprised of subretinal haemorrhage and/or up to 25% fibrotic scar or atrophic damage.
Maltese: Iż-żewġ studji rreġistraw pazjenti, li kienu jinkludu s-sottotipi kollha tal-feriti minn AMD neovaskulari (25% il-biċċa l-kbira klassiċi, 39% okkulti mingħajr ebda ferita klassika u 36% minimament klassiċi), daqsijiet tal-ferita sa 12 disc areas, li minnhom sa 50% setgħu jkunu ffurmati minn emorraġija taħt ir-retina u/jew sa 25% ċikatriċi fibrotika jew ħsara atrofika.
English: Uncommon asthenopia, blepharitis, conjunctivitis allergic, corneal deposits, eye haemorrhage, eyelids pruritus, keratitis, vitreous haemorrhage, pupillary reflex impaired, corneal abrasion, retinal exudates, eyelid ptosis, retinal scar, chalazion, corneal erosion, decreased intraocular pressure, injection site reaction, injection site vesicles, retinal detachment, corneal disorder, retinal artery occlusion, retinal tear, ectropion, eye movement disorder, eyelid irritation, hyphaema, pupillary disorder, iris disorder, ocular icterus, anterior uveitis, deposit eye, iritis, optic nerve cupping, pupillary deformity, retinal vein occlusion, and vitreous prolapse
Maltese: Mhux komuni asthenopia, blefarite, konġuntivite allerġika, depożiti talkornea, emorraġija fl-għajn, ħakk fil-kpiepel ta' l-għajnejn, keratite, emorraġija fil-vitriju, indeboliment tar-rifless pupillari, brix tal-kornea, effużjonijiet tar-retina, ptosi talkappell ta' l-għajn, ċikatriċi tar-retina, chalazion, erużjoni tal-kornea, tnaqqis tal-pressjoni ġo l-għajn, reazzjoni fil-post ta' l-injezzjoni, bżieżaq fil-post ta' l-injezzjoni, stakkar tarretina, disturb fil-kornea, okklużjoni ta' l-arterja tar-retina, tiċrit tar-retina, ectropion, disturb fil-moviment ta' l-għajn, irritazzjoni fil-kappell ta' l-għajn, hyphaema, disturb filpupilla, disturb fil-ħabba ta' l-għajn, icterus ta' l-għajn, uveite anterjuri, depożitu fl-għajn, infjammazzjoni tal-ħabba ta' l-għajn, cupping tan-nerv ottiku, deformazzjoni talpupilla, okklużjoni tal-vina tar-retina, u prolass tal-vitriju
English: Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults (see section 5.1).
Maltese: Macugen hu indikat f'pazjenti adulti għall-kura tad-deġenerazzjoni makulari neovaskulari (imxarrba) relatata ma' l-eta' (AMD - age-related macular degeneration) (ara sezzjoni 5.1).
English: There is a theoretical risk of arterial thromboembolic including stroke and myocardial infarction events following intravitreal use of VEGF inhibitors.
Maltese: Hemm riskju teoretiku ta' avvenimenti tromboemboliċi arterjali inkluż puplesija u infart mijokardjiku wara l-użu ta' inibituri VEGF ġolvitriju.
English: Distribution, biotransformation and elimination:
Maltese: Distribuzzjoni, bijotrasformazzjoni u tneħħija:
English: In the 40 mg/kg/day group, pegaptanib concentrations in the amniotic fluid were 0.05% of the maternal plasma levels.
Maltese: Fil-grupp ta' 40 mg/kg/ġurnata, ilkonċentrazzjonijiet ta' pegaptanib fil-fluwidu tal-borqom kienu 0.05% tal-livelli fil-plasma ta' l-omm.
English: • disorder of the surface of the eye (cornea)
Maltese: • disturb tas-superfiċje tal-għajn (kornea)
English: Clinical efficacy and safety
Maltese: Effikaċja u Sigurtà klinika
English: However, there was no consistent pattern among the different haemorrhages.
Maltese: Madankollu, ma kien hemm ebda disinn konsistenti fost l-emorraġiji differenti.
English: Not known angioedema*
Maltese: Reazzjoni anafilattika*
English: Common abnormal sensation in eye, cataract, conjunctival haemorrhage, conjunctival hyperaemia, conjunctival oedema, conjunctivitis, corneal dystrophy, corneal epithelium defect, corneal epithelium disorder, corneal oedema, dry eye, endophthalmitis, eye discharge, eye inflammation, eye irritation, eye pruritus, eye redness, eye swelling, eyelid oedema, lacrimation increased, macular degeneration, mydriasis, ocular discomfort, ocular hypertension, periorbital haematoma, photophobia, photopsia, retinal haemorrhage, vision blurred, visual acuity reduced, visual disturbance, vitreous detachment, and
Maltese: Komuni sensazzjoni abnormali fl-għajn, katarretta, emorraġija konġunktivali, iperimija konġunktivali, edema konġunktivali, konġuntivite, distrofija tal-kornea, difett flepithelium tal-kornea, disturb fl-epithelium tal-kornea, edema tal-kornea, għajn xotta, endophthalmitis, tnixxija mill-għajn, infjammazzjoni ta' l-għajn, irritazzjoni ta' lgħajn, ħakk fl-għajn, ħmura fl-għajn, nefħa fl-għajn, edema fil-kappell ta' l-għajn, żieda fit-tidmigħ, deġenerazzjoni makulari, mydriasis, diqa fl-għajn, pressjoni għolja fl-għajn, ematoma madwar l-orbita, fotofobija, fotopsja, emorraġija mir-retina, vista mċajpra, tnaqqis ta' l-akutezza viżwali, disturb viżwali, stakkar tal-vitriju, u disturb tal-vitriju
English: The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric (bromobutyl/synthetic isoprene) tip cap.
Maltese: Is-siringa għandha adapter tal-plastik tat-tip polycarbonate tal-lukkett luer, u t-tapp huwa issiġillat b'kappa elastomerika (bromobutyl/synthetic isoprene).
English: 0.3 mg N=265
Maltese: Sham N=272
English: Pegaptanib was studied in two controlled, double-masked, and identically designed randomised studies (EOP1003; EOP1004) in patients with neovascular AMD.
Maltese: Pegaptanib ġie studjat f'żewġ studji kkontrollati, double-masked, imfasslin b'mod identiku u mwettqa b'għażla kawżwali (EOP1003; EOP1004) f'pazjenti b'AMD neovaskulari.
English: Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: Intravitreal injection procedures are associated with a risk of endophthalmitis; in Macugen clinical trials, the incidence of endophthalmitis was 0.1% per injection (see section 4.2).
Maltese: Il-proċeduri ta' injezzjoni ġol-vitriju huma assoċjati ma' riskju ta' endophthalmitis; fi provi kliniċi b'Macugen, l-inċidenza ta' endophthalmitis kienet 0.1% kull injezzjoni (ara sezzjoni 4.2).
English: Macugen is a solution which is injected into the eye. Pegaptanib, the active substance of this medicine, inhibits the activity of the factor involved in the abnormal formation of new blood vessels in the eye, known as Vascular Endothelial Growth Factor165 (VEGF165).
Maltese: Pegaptanib, is-sustanza attiva ta' din il-mediċina, jinibixxi l-attività tal-fattur involut fil-formazzjoni anormali tal-vini ġodda fl-għajn, magħrufa bħala endotilju vaskulari Factor165 (VEGF165).
English: - The active substance is pegaptanib.
Maltese: - Is-sustanza attiva hija pagaptinib.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeltrali u talconnective
English: Mean Change in Visual Acuity Over Time; Year 1; ITT (LOCF)
Maltese: Bidla Medja fl-Akutezza Viżwali Maż-Żmien; L-Ewwel Sena; ITT (LOCF)
English: Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide and hydrochloric acid (for pH adjustment), water for injections.
Maltese: Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide u hydrochloric acid (għall-aġġustament tal-pH), ilma għall-injezzjonijiet
English: For additional information regarding sodium content of Macugen, see section
Maltese: Għal informazzjoni addizzjonali dwar ilkontenut ta' sodium ta' Macugen, ara sezzjoni 2.
English: • irritation and inflammation of the skin, hair colour changes, rash, itching,
Maltese: • irritazzjoni u infjammazzjoni tal-ġilda, bidliet fil-kulur tax-xagħar, raxx, ħakk
English: A 27 or 30 G x ½ inch needle should be attached to the luer lock adaptor, to allow the administration of the medicinal product (see Figure 1, below).
Maltese: Labbra 27 jew 30G x ½ pulzier għandha titwaħħal ma' l-adapter tal-lukkett luer, sabiex ikun jista' jingħata l-prodott mediċinali (Ara Stampa 1, hawn taħt).
English: Pegaptanib pharmacokinetics is similar in female and male patients and within the age range 50 to 90 years.
Maltese: Il-farmakokinetika ta' pegaptanib hija simili fil-pazjenti nisa u rġiel u fil-medda ta' etajiet ta' 50 sa 90 sena.
English: Macugen 0.3 mg solution for injection Pegaptanib
Maltese: Macugen 0.3 mg Injezzjoni pegaptanib
English: In humans, the average ± standard deviation apparent plasma half-life of pegaptanib after a 3 mg (10-times the recommended dose) monocular dose is 10 ± 4 days.
Maltese: Fil-bniedem, il-half life medja ± devjazzjoni standard apparenti ta' pegaptanib fil-plasma wara doża ta' 3 mg (10 darbiet iddoża rakkomandata) għal għajn waħda hi 10 ± 4 ijiem.
English: Cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in patients within several hours after administration of pegaptanib along with various medicinal products administered as part of the injection preparation procedure (see sections 4.2 and 4.4).
Maltese: Każijiet rari ta' anafilassi/reazzjonijiet anaphylactoid, fosthom anġoedema, ġew irrapportati fil-pazjenti sa diversi sigħat wara l-amministrazzjoni ta' pegaptanib ma' diversi prodotti mediċinali mogħtija bħala parti mill-proċedura ta' preparazzjoni għall-injezzjoni (ara sezzjonijiet 4.2 u 4.4).
English: Pegaptanib produced no maternal toxicity and no evidence of teratogenicity or foetal mortality in mice at intravenous doses of 1 to 40 mg/kg/day.
Maltese: Pegaptanib ma pproduċa ebda tossiċità fl-omm u ebda evidenza ta' teratoġeniċità jew mortalità tal-fetu fil-ġrieden b'dożi ġol-vina ta' 1 sa 40 mg/kg/ġurnata.
English: 5.2 Pharmacokinetic properties
Maltese: 5.2 Tag rif farmakokinetiku ħ
English: In the wet form of AMD, abnormal blood vessels grow under the retina and macula.
Maltese: Fil-forma mxarrba ta' AMD, vini u arterji abnormali jikbru taħt ir-retina u l-makula.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilmediċini: http://www.ema.europa.eu/
English: Pharmacotherapeutic group: Ophthalmologicals, Ocular vascular disorder agents, ATC Code S01LA03.
Maltese: Oftalmoloġiċi, Aġent kontra d-disturbi vaskulari fl-għajnejn, Kodiċi ATC:
English: Verteporfin photodynamic therapy (PDT) was permitted in patients with predominantly classic lesions at the discretion of the investigators.
Maltese: Terapija fotodinamika b'verteporfin (PDT) kienet permessa f'pazjenti li kellhom feriti l-biċċa l-kbira klassiċi fid-diskrezzjoni ta' l-investigaturi.
English: • decreased vision
Maltese: • vista mnaqqsa
English: Overfill volume
Maltese: NUMRU TAL-LOTT
English: In rabbits, pegaptanib is eliminated as parent drug and metabolites primarily in the urine.
Maltese: Fil-fniek, pegaptanib jiġi eliminat bħala droga oriġinali u metaboliti prinċipalment fl-awrina.
English: • clouding of the lens (cataract)
Maltese: • tidnis tal-lenti (katarretta)
English: Pegaptanib is a pegylated modified oligonucleotide that binds with high specificity and affinity to extracellular Vascular Endothelial Growth Factor (VEGF165) inhibiting its activity.
Maltese: Pegaptanib hu pegylated modified oligonucleotide li jaqbad bi speċifiċità u affinità kbira mal-Fattur Endoteljali Vaskulari ekstraċellulari tat-Tkabbir (VEGF165) biex jimpedixxi l-attività tiegħu.
English: Macugen is used for the treatment of the wet form of age-related macular degeneration (AMD).
Maltese: Macugen jintuża għall-kura tal-forma mxarrba tad-deġenerazzjoni makulari relatata ma' l-eta' (AMD).
English: 6.1 List of excipients
Maltese: ċċ 6.1 Lista ta' e ipjenti
English: • inflammation of the central part of the surface of the eye (keratitis)
Maltese: • infjammazzjoni tal-parti ċentrali tas-superfiċje tal-għajn (keratite)
English: Ear and labyrinth disorders Uncommon deafness, Meniere's disease aggravated, vertigo
Maltese: Mhux komuni truxija, aggravament tal-marda ta' Meniere, vertigo
English: No human data on the effect of Macugen on fertility are available.
Maltese: M'hemmx data umana disponibli fuq l-effett ta' Macugen fuq il-fertilità.
English: A decrease in creatinine clearance down to 20 ml/min may be associated with up to a 2.3-fold increase in pegaptanib AUC.
Maltese: Tnaqqis fi clearance tal-kreatinina sa 20 ml/min jista' jkun assoċjat ma' żieda ta' 2.3 drabi flAUC ta' pegaptanib.
English: Overdose with Macugen has not been reported in clinical trials.
Maltese: Doża eċċessiva b'Macugen ma ġietx rrapportata fil-provi kliniċi.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Maltese: Qabel it-tnedija f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel mal-Awtorità Kompetenti Nazzjonali fuq il-materjal edukattiv finali.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘mingħajr sodium'.
English: Delivers a single dose of 0.3 mg in 90 microliters Pack of one pre-filled syringe, a plunger stopper and a pre-attached plunger rod.
Maltese: Tagħti doża waħda ta' 0.3 mg f' 90 mikrolitru Pakkett ta' siringa waħda mimlija għal-lest, stopper talplunġer u qasba tal-plunġer mwaħħla lesta.
English: Each single dose pre-filled syringe delivers a dose of 0.3 mg pegaptanib in 90 microlitres.
Maltese: Kull siringa ta' doża waħda mimlija lesta tagħti doża ta' 0.3 mg pegaptinib f'90 mikrolitru.
English: Respiratory, thoracic and mediastinal disorders Common rhinorrhea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: • bloodshot eye (conjunctival haemorrhage)
Maltese: • għajnejn ħomor (emorraġija konġunktivali)
English: The medicine is used for the treatment of all types of abnormal blood vessels growth in adult AMD patients.
Maltese: Il-mediċina tintuża għall-kura ta' kull tip ta' tkabbir ta' vini u arterji abnormali f'pazjenti adulti bl-AMD.
English: VEGF is a secreted protein that induces angiogenesis, vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD.
Maltese: hija proteina merħija li tinduċi anġoġenesi, permeabilità vaskulari u infjammazzjoni, li kollha huma maħsuba li jikkontribwixxu għall-progressjoni tal-forma neovaskulari (imxarrba) ta' AMD.
English: Pharmaswiss Hellas A.E. Τλ: +30 210 8108 460
Maltese: Τλ: +30 210 8108 460
English: (Actual air bubble formation may vary)
Maltese: (Il-bużżieqa tal-arja attwali tista' tvarja)
English: The absolute bioavailability of pegaptanib after intravitreal administration has not been assessed in humans, but is approximately 70-100% in rabbits, dogs and monkeys.
Maltese: Il-bijodisponibilità assoluta ta' pegaptanib wara amministrazzjoni ġol-vitriju ma ġietx imkejla filbniedem, iżda hija madwar 70-100% fil-fniek, il-klieb u x-xadini.
English: Kypropharm Ltd. Τηλ: + 357 22 43 46 99
Maltese: Τηλ: + 357 22 43 46 99 Latvija
English: PHARMACOLOGICAL PROPERTIES
Maltese: TAGRIF FARMAKOLO
English: The recommended dose is 0.3 mg pegaptanib, equivalent to 90 microliters, administered once every six weeks (9 injections per year) by intravitreal injection into the affected eye.
Maltese: Id-doża rakkomandata hija 0.3 mg pegaptanib ekwivalenti għal 90 mikrolitru, amministrata darba kull sitt ġimgħat (9 injezzjonijiet fis-sena) permezz ta' injezzjoni ġol-vitriju fl-għajn affettwata.
English: Other medicines and Macugen
Maltese: Medi ini o ra ħ u Macugen
English: You must not be given Macugen:
Maltese: Inti ma tridx tingħata Macugen:
English: • retinal artery occlusion
Maltese: • okklużjoni tal-arterja tar-retina
English: The systemic exposure to pegaptanib is expected to be very low after ocular administration.
Maltese: L-espożizzjoni sistemika għal pegaptanib hi mistennija li tkun baxxa ħafna wara amministrazzjoni fl-għajnejn.
English: Each pre-filled syringe contains approximately 0.25-0.27 ml of solution.
Maltese: Kull siringa mimlija għal-lest fiha madwar 0.25-0.27 ml ta' soluzzjoni.
English: In the clinical trial, the overall frequency of non-ocular haemorrhages, an adverse event potentially related to systemic VEGF (vascular endothelial growth factor) inhibition, was slightly increased in intravitreal VEGF inhibitor-treated patients.
Maltese: Fil-prova klinika, l-frekwenza globali ta' emorraġiji mhux okulari, avveniment avvers potenzjalment relatat mal-inibizzjoni ta' VEGF sistemiku (fattur tat-tkabbir endoteljali vaskulari), żdiedet kemmxejn fil-pazjenti kkurati b'inibitur VEGF fil-vitriju.
English: The selective inhibition in animals with pegaptanib proved as effective at suppressing pathological neovascularisation as pan-VEGF inhibition, however pegaptanib spared the normal vasculature whereas pan-VEGF inhibition did not.
Maltese: L-inibizzjoni selettiva fl-annimali b'pegaptanib irriżultat effettiva fit-trażżin tanneovaskularizzazzjoni patoloġika daqs l-inibizzjoni pan-VEGF, madankollu pegaptanib m'għamilx ħsara lill-vaskulatura normali filwaqt li inibizzjoni pan-VEGF għamlet.
English: Important information about some of the ingredients of Macugen This medicine contains less than 1 mmol sodium (23 mg) per 90 microlitre dose, i.e. essentially ‘sodium-free' (see section 6).
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' MacugenDin il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża ta' 90 mikrolitru, jiġifieri essenzjalment ‘mingħajr sodium' (ara sezzjoni 6).
English: Uncommon nasopharyngitis
Maltese: Reazzjoni avversa
English: A few cases of arterial thromboembolic events were observed in the pegaptanib clinical trials in patients with AMD, DME, and there were no major differences between the groups treated with pegaptanib compared to control.
Maltese: Ftit każijiet ta' avvenimenti tromboemboliċi arterjali kienu osservati fil-provi kliniċi ta' pegaptanib f'pazjenti b'AMD, DME u ma kienx hemm differenzi kbar bejn il-gruppi kkurati b'pegaptanib meta mqabbla ma' kontroll.
English: • inflammation of the eye (iritis)
Maltese: • infjammazzjoni tal-għajn (irite)
English: Psychiatric disorders Uncommon nightmare, depression
Maltese: Disturbi psikjatriċi Mhux komuni ħmar il-lejl, depressjoni
English: LIST OF EXCIPIENTS
Maltese: KLASSIFIKAZZJONI EN
English: If you are pregnant discuss this with your doctor before treatment with Macugen.
Maltese: Ma sarux studji dwar l-interazzjoni ta' Macugen ma' mediċini oħra.
English: In rabbits, the component nucleotide, 2'-fluorouridine is found in plasma and urine after single radiolabeled pegaptanib intravenous and intravitreal doses.
Maltese: Fil-fniek, in-nucleotide komponenti, 2'-fluorouridine jinstab filplasma u fl-awrina wara dożi waħdiena ta' pegaptanib radjutikkettat ġol-vitriju jew fil-plasma.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn 100)
English: A mean maximum plasma concentration of about 80 ng/ml occurs within 1 to 4 days after a 3 mg monocular dose in humans.
Maltese: Konċentrazzjoni massima medja fil-plasma ta' madwar 80 ng/ml isseħħ fi żmien 1 sa 4 ijiem wara doża ta' 3 mg għal għajn waħda fil-bniedem.
English: • disturbance in your eye's reaction to the light (pupillary reflex impaired)
Maltese: • disturb fir-reazzjoni ta' għajnejk għad-dawl (indeboliment tar-rifless pupillari)