FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy and safety of Kyntheum was assessed in 4373 adult plaque psoriasis patients across three multinational, randomised, double-blind, phase 3, placebo-controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3).
Maltese: L-effikaċja u s-sigurtà ta' Kyntheum ġiet evalwata f'4,373 pazjenti adulti bi psorjasi tal-plakka fi tliet provi kliniċi multinazzjonali, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ta' fażi 3,
English: Figure 1: PASI 100 during induction and maintenance phase for Kyntheum and ustekinumab (AMAGINE-2 and AMAGINE-3, pooled)
Maltese: ikkontrollati bi plaċebo (AMAGINE-1, AMAGINE-2, u AMAGINE-3).
English: In cynomolgus monkeys, after weekly subcutaneous dosing of brodalumab at dose levels up to 90 mg/kg for 6 months, brodalumab-related effects were limited to injection site reactions and mucocutaneous inflammation that was consistent with pharmacologic modulation of host surveillance to commensal microflora.
Maltese: F'xadini cynomolgus, wara l-għoti ta' doża taħt il-ġila kull ġimgħa, ta' brodalumab f'livelli ta' doża sa 90 mg/kg għal 6 xhur, l-effetti relatati ma' brodalumab kienu limitati għal reazzjonijiet fis-sit tal-injezzjoni u infjammazzjoni mukokutanja li kienet konsistenti mal-modulazzjoni farmakoloġika tas-sorveljanza tal-ospitu għal commensal microflora.
English: Patients randomised to ustekinumab received 45 mg for patients ≤100 kg and 90 mg for patients >100 kg at Weeks 0, 4, and 16 followed by same dose every 12 weeks.
Maltese: Pazjenti li ntgħażlu b'mod każwali għal ustekinumab, irċivew doża ta' 45 mg għal pazjenti li jiżnu ≤100 kg, jew 90 kg għal pazjenti li jiżnu >100 kg, f'Ġimgħat 0, 4, u 16, segwita mill-istess doża kull 12-il ġimgħa.
English: Blocking IL-17RA inhibits IL-17 cytokine-induced responses resulting in normalization of inflammation in the skin.
Maltese: L-imblukkar ta' IL-17RA jinibixxi risponsi indotti mis-cytokines ta' IL-17, u dan jirriżulta fin-normalizzazzjoni tal-infjammazzjoni fil-ġilda.
English: • cotton ball or gauze pad
Maltese: • tajjara jew pad tal-garża
English: Always hold the syringe by the syringe barrel.
Maltese: Hu normali li tara qatra ta' likwidu fit-tarf tal-labra.
English: Infections Kyntheum may increase the risk of infections.
Maltese: Kyntheum jista' jżid ir-riskju ta' infezzjonijiet.
English: The recommended dose is 210 mg (one injection).
Maltese: Id-doża rakkomandata hi ta' 210 mg (injezzjoni waħda).
English: Each syringe contains one 210 mg dose of Kyntheum.
Maltese: segwiti minn 210 mg kull ġimagħtejn.
English: • Do not use after the expiry date on the label.
Maltese: • Tużax wara d-data ta' skadenza li tidher fuq it-tikketta.
English: Through Week 52, the exposure-adjusted event rates (per 100 patient-years) for infections were 114.6 for patients treated with Kyntheum and 118.1 for patients treated with ustekinumab.
Maltese: Sa Gimgħa 52, ir-rati ta' avvenimenti aġġustati għall-esponiment (għal kull 100 sena ta' pazjent) għal infezzjonijiet kienu ta' 114.6 għal pazjenti kkurati b'Kyntheum u 118.1 għal pazjenti kkurati b'ustekinumab.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: Higher rates of fungal infections, primarily non-serious skin and mucosal candida infections, were observed in Kyntheum patients compared to placebo patients, 1.8% vs 0.9%, respectively.
Maltese: Rati ogħla ta' infezzjonijiet fungali, l-aktar infezzjonijiet mhux serji tal-ġilda u candida mukożali, kienu osservati f'pazjenti kkurati b'Kyntheum meta mqabbla ma' pazjenti kkurati bi plaċebo, 1.8% vs 0.9%,
English: No cases of active tuberculosis were reported from clinical trials.
Maltese: L-ebda każijiet ta' tuberkulożi attiva ma ġew irrappurtati mill-provi kliniċi.
English: E.J.
Maltese: J.
English: Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C and IL-17E (also known as IL-25), resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis.
Maltese: IgG2 uman kompletament rikombinanti, li jeħel b'affinità għolja ma' IL-17RA u jimblokka l-attivitajiet bijoloġiċi tas-cytokines proinfjammatorji
English: • alcohol wipes
Maltese: • biċċiet bl-alkoħol
English: Following a single subcutaneous administration of brodalumab 210 mg in plaque psoriasis patients, the apparent clearance (CL/F) is 2.95 L/day.
Maltese: Wara għoti wieħed taħt il-ġilda ta' brodalumab 210 mg f'pazjenti bi psorjasi tal-plakka, it-tneħħija apparenti (CL/F) hi ta' 2.95 L/jum.
English: For a 3-fold increase in SC brodalumab dose from 70 to 210 mg, the steady-state serum brodalumab Cmax and AUC0-t increased approximately 18- and 25-fold, respectively.
Maltese: is-Cmax u l-AUC0-t ta' brodalumab fis-serum fl-istat stabbli żdiedu b'madwar 18 u 25 darba, rispettivament.
English: and baseline involved body surface area (BSA) ranged from 10 to 97 (median: 21).
Maltese: 72 (medjan: 17.4) u l-erja tas-superfiċje tal-ġisem (BSA, body surface area) involuta fil-linja bażi kienet tvarja minn 10 sa 97 (medjan: 21).
English: Label and expiry date
Maltese: Tikketta u data ta' skadenza
English: Used syringe barrel
Maltese: Armi s-siringa użata
English: Based on an exploratory descriptive analysis, no relationship was observed between exposure and incidence of serious infections and infestations, candida infections, viral infections, and suicidal ideation and behaviour events.
Maltese: infezzjonijiet u infestazzjonijiet serji, infezzjonijiet b'candida, infezzjonijiet virali, u avvenimenti ta'
English: Patients were predominantly men (69%) and white (91%), with a mean age of 45 years (18 to 86 years), of these 6.1% were >65 years of age and 0.3% were >75 years of age.
Maltese: Il-pazjenti kienu l-aktar irġiel (69%) u bojod (91%), b'età medja ta' 45 sena (18 sa 86 sena).
English: In cynomolgus monkeys there were no effects on male and female reproductive organs and on sperm count, motility and morphology following administration of brodalumab at dose levels up to 90 mg/kg once weekly for 6 months, (AUC exposure up to 47-fold higher than in human patients receiving Kyntheum 210 mg every 2 weeks).
Maltese: F'xadini cynomolgus, ma kien hemm l-ebda effetti fuq l-organi riproduttivi tal-irġiel u n-nisa u fuq l-għadd, il-motilità u l-morfoloġija tal-isperma, wara l-għoti ta' dożi ta' brodalumab f'livelli sa 90 mg/kg darba kull ġimgħa għal 6 xhur (esponiment AUC sa 47 darba ogħla mill f'pazjenti umani li kienu qed jirċievu Kyntheum 210 mg kull ġimagħtejn).
English: Human IgG2 is known to cross the placental barrier and brodalumab is a human IgG2, therefore, brodalumab has the potential to be transmitted from the mother to the developing foetus.
Maltese: Hu magħruf li IgG2 uman jaqsam mill-plaċenta, u brodalumab hu IgG2 uman.
English: Population pharmacokinetic modelling predicted that serum brodalumab concentrations dropped below the quantification limit (0.05 mcg/ml) 63 days after discontinuation of steady-state dosing of brodalumab 210 mg administered every 2 weeks in 95% of the patients.
Maltese: Immudellar farmakokinetiku tal-popolazzjoni bassret li l-konċentrazzjonijiet ta' brodalumab fis-serum niżlu taħt il-limitu ta' kwantifikazzjoni (0.05 mcg/ml) 63 jum wara t-twaqqif tad-dożaġġ fl-istat fiss ta'
English: Uncommon side effects (may affect up to 1 in 100 people)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 persuna minn kull 100)
English: • plaster
Maltese: • stikk
English: Kyntheum can be kept at room temperature up to 25°C in the outer carton for 14 days.
Maltese: Kyntheum jista' jinżamm fit-temperatura tal-kamra, sa 25°C, fil-kartuna ta' barra, għal 14-il jum.
English: Kyntheum is administered by subcutaneous injection.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Population pharmacokinetic analysis indicated that gender did not have an effect on brodalumab pharmacokinetics.
Maltese: Analiżi farmakokinetika tal-popolazzjoni indikat li s-sess tal-persuna ma kellux effett fuq il-farmakokinetika ta' brodalumab.
English: Busuttil Ltd Tel: +356 2144 7184
Maltese: Tel: +356 2144 7184
English: Step 3: Injecting
Maltese: Pass 2: Lesti biex injetta
English: The proportion of patients who achieved a Psoriasis Symptom Inventory (PSI) score of 0 (not at all) or 1 (mild) on every item (itch, burning, stinging, pain, redness, scaling, cracking and flaking) at Week 12 are shown in Table 2.
Maltese: Il-proporzjon ta' pazjenti li kisbu punteġġ ta' Inventarju tas-Sintomi tal-Psorjasi (Psoriasis Symptom Inventory, PSI) ta' 0 (xejn) jew 1 (ħafif) fuq kull sintomu (ħakk, ħruq, tingiż, uġigħ, ħmura, ġilda li titqaxxar, qsim tal-ġilda u ġilda mqaxxra) f'Ġimgħa 12 qed jintwerew f'Tabella 2.
English: Concomitant immunosuppressive therapy
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation.
Maltese: Il-formazzjoni ta' enzimi ta' CYP450 tista' tinbidel minn żieda fil-livelli ta' ċerti cytokines (eż. IL-1,
English: During the 12-week placebo-controlled trial period in plaque psoriasis, infections were reported in 25.4% of patients treated with Kyntheum compared with 23.4% of patients treated with placebo.
Maltese: Matul il-perjodu tal-prova kkontrollata bi plaċebo li dam 12-il ġimgħa li saret fuq pazjenti bi psorjasi tal-plakka, infezzjonijiet ġew irrappurtati f'25.4% tal-pazjenti kkurati b'Kyntheum meta mqabbla ma' 23.4% tal-pazjenti kkurati bi plaċebo.
English: Diarrhoea Nausea
Maltese: infezzjoni serja.
English: Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Maltese: Kyntheum hu disponibbli f'pakketti ta' doża waħda li fihom 2 siringi mimlija għal-lest u f'pakketti multipli li fihom 6 (3 pakketti ta' 2) siringi mimlija għal-lest.
English: Neutropenia
Maltese: Influwenza
English: The majority of infections consisted of nasopharyngitis, upper respiratory tract infection, pharyngitis, urinary tract infections, bronchitis, and influenza, which did not necessitate treatment discontinuation.
Maltese: Il-maġġoranza tal-infezzjonijiet kienu jikkonsistu minn nażofarinġite, infezzjoni fil-parti ta' fuq tal-passaġġ respiratorju, farinġite, infezzjonijiet fil-passaġġ urinarju, bronkite, u influwenza, li ma kinux jeħtieġu t-twaqqif tal-kura.
English: Using Kyntheum will benefit you by leading to improvements of skin clearance and reducing psoriasis signs and symptoms, such as itch, redness, scaling, burning, stinging, cracking, flaking and pain.
Maltese: Kyntheum m'għandux jiġi injettat f'żoni fejn il-ġilda tkun sensittiva, imbenġla, ħamra, iebsa, ħoxna, bil-qxur, jew affettwata mill-psorjasi.
English: With the grey needle cap off, insert the syringe into your skin at somewhere between 45 and 90 degrees
Maltese: Bl-għatu griż tal-labra maqlugħ, daħħal is-siringa ġol-ġilda f'angolu bejn 45 u 90 grad
English: Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology (see section 5.3).
Maltese: Studji fl-annimali ma wrew l-ebda effetti fuq l-organi riproduttivi tal-irġiel u n-nisa u fuq l-għadd, il-motilità u l-morfoloġija tal-isperma (ara sezzjoni 5.3).
English: No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Maltese: M'hemmx dejta farmakokinetika disponibbli għal pazjenti b'indeboliment fil-funzjoni tal-kliewi jew tal-fwied.
English: • Clean the area where you plan to inject with an alcohol wipe.
Maltese: • jekk dan l-aħħar inti rċivejt, jew inti skedat biex tirċievi tilqima.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: The safety and efficacy of Kyntheum in children and adolescents below the age of 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Kyntheum fi tfal u adolexxenti li għandhom inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Kyntheum is not recommended for children and adolescents (below 18 years of age) because it has not been studied in this age group.
Maltese: Kyntheum mhuwiex rakkomandat għal tfal u adolexxenti (taħt it-18-il sena) minħabba li ma ġiex studjat f'dan il-grupp ta' età.
English: Patients randomised to Kyntheum received 210 mg or 140 mg at Week 0 (day 1), Week 1, and Week 2 followed by same dose every 2 weeks.
Maltese: irċivew doża ta' 210 mg jew 140 mg f'Ġimgħa 0 (jum 1), Ġimgħa 1, u Ġimgħa 2, segwita mill-istess doża kull ġimagħtejn.
English: How to store Kyntheum
Maltese: Kemm se jingħata Kyntheum
English: However, there were no proliferative changes in cynomolgus monkeys administered weekly subcutaneous doses of brodalumab at 90 mg/kg for 6 months (AUC exposure 47-fold higher than in human patients receiving Kyntheum 210 mg every 2 weeks).
Maltese: Madankollu, ma kien hemm l-ebda bidliet proliferattivi f'xadini cynomolgus li ngħataw dożi ta' brodalumab 90 mg/kg taħt il-ġilda kull ġimgħa għal 6 xhur (esponiment AUC 47 darba ogħla mill f'pazjenti umani li kienu qed jirċievu Kyntheum 210 mg kull ġimagħtejn).
English: N = number of patients, which are presented at baseline, Week 12, and Week 52 Q2W = every 2 weeks *Patients were administered ustekinumab in the induction phase and continued on ustekinumab in the maintenance phase **Patients were administered Kyntheum 210 mg every 2 weeks in the induction phase and re-randomised to Kyntheum 210 mg every 2 weeks in the maintenance phase NRI= Non-responder imputation
Maltese: ** Il-pazjenti ngħataw Kyntheum 210 mg kull ġimagħtejn fil-fażi ta' induzzjoni u ntagħżlu b'mod każwali mill-ġdid għal Kyntheum 210 mg kull ġimagħtejn fil-fażi ta' manteniment
English: At Week 12, patients in the ustekinumab group continued to receive ustekinumab and then were switched to Kyntheum 210 mg every 2 weeks at Week 52.
Maltese: ustekinumab komplew jirċievu ustekinumab u mbagħad inqalbu għal Kyntheum 210 mg kull ġimagħtejn f'Ġimgħa 52.
English: Syringe barrel
Maltese: Bettija tas-siringa użata
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Maltese: tip speċjalizzat ta' proteini li jagħrfu u jeħlu ma' ċerti proteini fil-ġisem.
English: Across treatment groups, the baseline Psoriasis Area Severity Index (PASI) score ranged from 9.4 to 72 (median: 17.4)
Maltese: Fil-gruppi kollha tal-kura, il-punteġġ fil-linja bażi tal-Indiċi tas-Severità tal-Erja bi Psorjasi (PASI, Psoriasis Area Severity Index) varja minn 9.4 sa
English: Thigh
Maltese: Glutamate
English: During the 12-week placebo-controlled clinical trial period in patients with psoriasis, a decrease in absolute neutrophil count (ANC) was observed in 5.6% of patients receiving Kyntheum, which was generally transient and reversible.
Maltese: Matul il-perjodu ta' prova ta' 12-il ġimgħa, ikkontrollat bi plaċebo, f'pazjenti bi psorjasi, ġie osservat tnaqqis fl-għadd assolut tan-newtrofili (ANC, absolute neutrophil count) f'5.6% tal-pazjenti li kienu qed jirċievu Kyntheum, li kien ġeneralment temporanju u riversibbli.
English: • new syringe
Maltese: Kyntheum"
English: Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 210 mg brodalumab f'1.5 ml soluzzjoni.
English: Fatigue
Maltese: LOTT
English: Immunogenicity
Maltese: Newtropenija
English: 1.5 ml solution in a type I glass pre-filled syringe with stainless steel 27G x ½” needle, covered with an elastomeric needle cap.
Maltese: 1.5 ml soluzzjoni f'siringa tal-ħġieġ ta' tip I mimlija għal-lest, b'labra 27G x ½” ta' azzar li ma jsaddadx, miksija b'għatu tal-labra elastomeriku.
English: Pregnancy There are no or limited amount of data from the use of brodalumab in pregnant women.
Maltese: M'hemmx dejta jew hemm dejta limitata dwar l-użu ta' brodalumab f'nisa tqal.
English: • if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
Maltese: • jekk tkun qed tirċievi kwalunkwe kura oħra għall-psorjasi, bħal immunosoppressant ieħor jew fototerapija b'dawk ultravjola (UV).
English: • if you have been told you have tuberculosis.
Maltese: • jekk qalulek li għandek it-tuberkulożi.
English: IL-17 family cytokine levels have been reported to be increased in psoriasis.
Maltese: Il-livelli ta' cytokines tal-familja IL-17 ġew irrappurtati li jiżdiedu f'persuni bil-psorjasi.
English: Kyntheum is used in adults with moderate to severe plaque psoriasis affecting large areas of the body.
Maltese: Kyntheum jintuża fl-adulti bi psorjasi tal-plakka moderata sa severa li taffettwa partijiet kbar tal-ġisem.
English: During the 12-week placebo-controlled period of clinical trials, neutropenia was reported in 0.8% of patients treated with Kyntheum compared with 0.5% of patients treated with placebo.
Maltese: Matul il-perjodu ta' 12-il ġimgħa ta' provi kliniċi kkontrollati bi plaċebo, in-newtropenija ġiet irrappurtata f'0.8% tal-pazjenti kkurati b'Kyntheum meta mqabbla ma' f'0.5% tal-pazjenti kkurati bi plaċebo.
English: Store in a refrigerator (2°C-8°C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2°C-8°C).
English: Used needle
Maltese: Aqbad hawn
English: • Do not shake the syringe.
Maltese: • Iċċaqlaqx bis-saħħa s-siringa.
English: • tinea (fungal) skin infections (including on feet and groin)
Maltese: Relazzjoni(-jiet) farmakokinetika(ċi)/farmakodinamika(ċi)
English: Infections and infestations
Maltese: Infezzjonijiet u infestazzjonijiet Komuni
English: Step 4: Finishing up J. Throw away the used syringe
Maltese: Pass 4: Temm il-proċess
English: Step 1: Preparing A. Remove the Kyntheum pre-filled syringe from the box
Maltese: Figura 1: PASI 100 matul il-fażi ta' induzzjoni u manteniment għal Kyntheum u ustekinumab
English: Other side effects that have been reported Common side effects (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 persuna minn kull 10):
English: Injection site reactions (including injection site erythema, pain, pruritus, bruising, haemorrhage)
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (li jinkludu eritema fis-sit tal-injezzjoni, uġigħ, ħakk, tbenġil, emorraġija)
English: The pre-filled syringe must not be shaken.
Maltese: Effetti sekondarji oħra li ġew irrappurtati
English: Reduced absolute neutrophil count
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni
English: • your thigh
Maltese: U L-UŻU
English: A risk to the newborns/infants cannot be excluded.
Maltese: Ir-riskju gћat-trabi tat-twelid mhux eskluż.
English: As the metabolism of brodalumab is unknown in infants, benefit risk for exposure of the infant to live vaccines following third trimester exposure to Kyntheum should be discussed with a physician.
Maltese: Billi l-metaboliżmu ta' brodalumab mhuwiex magħruf fit-trabi, il-benefiċċju u r-riskju għall-esponiment tat-tarbija għal tilqim ħaj wara esponiment għal Kyntheum fit-tielet trimestru, għandu jiġi diskuss ma' tabib.
English: Do not use this medicine after the expiry date which is stated on the outer carton and label of the prefilled syringe after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna ta' barra u fuq it-tikketta tas-siringa mimlija għal-lest wara EXP.
English: EU/1/12/791/001 Glybera
Maltese: EU/1/12/791/001 Glybera 3 x 10¹² gc/ml Soluzzjoni għal injezzjoni
English: Content Pack size
Maltese: Kontenut Daqs tal-pakkett
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 gc/kg bodyweight l t o r
Maltese: Kull pakkett speċifiku għallpazjent fih ammont suffiċjenti ta' kunjetti biex kull pazjent jingħata doża ta' 1 x 1012
English: 1 ml
Maltese: Kunjett (ħġieġ) 1 ml
English: Intramuscular use vial (glass)
Maltese: Użu intramuskolari
English: It contains two active substances: travoprost (40 micrograms per millilitre) and timolol (5 mg/ml).
Maltese: Fih żewġ sustanzi attivi: travoprost (40 mikrogrammi għal kull millilitru) u timolol (5 mg/ml).
English: Other information about DuoTrav:
Maltese: Informazzjoni oħra dwar DuoTrav:
English: This summary was last updated in 08-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 08-2010.
English: DuoTrav has been studied in five main studies involving a total of 1,482 patients (aged 18 to 91) with open-angle glaucoma or ocular hypertension.
Maltese: DuoTrav ġie studjat f'ħames studji ewlenin li b'kollox involvew 1,482 pazjent (ta' età bejn 18 u 91) bi glawkoma b'angolu miftuħ jew bi pressjoni okulari għolja.
English: This document is a summary of the European public assessment report (EPAR) for DuoTrav.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal DuoTrav.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for DuoTrav to Alcon Laboratories (UK) Limited on 24 April 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal DuoTrav lil Alcon Laboratories (UK) Limited fl-24 ta' April 2006.
English: It must also not be used in people with severe allergic rhinitis (inflammation of the nasal passages caused by an allergy) and corneal dystrophies (disorders that cause clouding of the cornea, the transparent layer in front of the eye).
Maltese: Ma għandux jintuża wkoll f'nies b'rinite allerġika severa (infjammazzjoni tal-passaġġi nasali ikkawżata minn allerġija) u distrofi korneali (disturbi li jikkawżaw ċpar tal-kornea, is-saff trasparenti quddiem l-għajn).
English: Why has DuoTrav been approved?
Maltese: Għaliex ġie approvat DuoTrav?
English: What is DuoTrav?
Maltese: X'inhu DuoTrav?
English: DuoTrav reduced the pressure inside the eye by about a third in all of the studies (the average reduction was about 8-10 mmHg).
Maltese: DuoTrav naqqas il-pressjoni fl-għajn b'xi madwar terz fl-istudji kollha (it-tnaqqis medju kien ta' madwar 8-10 mmHg).
English: In a patient with glaucoma, the eye pressure is usually higher than 21 mmHg.
Maltese: F'pazjent bi glawkoma, il-pressjoni fl-għajn hija normalment ogħla minn 21 mmHg.
English: It is used in adults with ‘open angle glaucoma' or ‘ocular hypertension' who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).
Maltese: Jintuża fl-adulti bi ‘glawkoma b'angolu miftuħ' jew bi ‘pressjoni okulari għolja' li ma jirrispondux b'mod suffiċjenti għal qtar tal-għajnejn li fih betaimblokkaturi jew analogi ta' prostaglandin (mediċini oħrajn użati għal dawn il-kundizzjonijiet).
English: DuoTrav contains benzalkonium chloride which is known to discolour soft contact lenses.
Maltese: DuoTrav jista' jinkiseb biss b'riċetta ta' tabib.
English: Travoprost is a prostaglandin analogue (a man-made copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Travoprost on its own has been authorised in the European Union as Travatan since 2001.
Maltese: Travoprost huwa analogu ta' prostaglandin (kopja magħmula mill-bniedem tas-sustanza naturali prostaglandin) li taħdem billi żżid id-drenaġġ tal-fluwidu barra mill-għajn.
English: The most common side effects with DuoTrav (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to redness) and eye irritation.
Maltese: L-effetti sekondarji l-aktar komuni b'DuoTrav (innutati f'aktar minn pazjent 1 minn 10) huma iperamija okulari (żieda fil-provvista tad-demm għall-għajn, li twassl għal ħmura) u irritazzjoni tal-għajn.
English: How has DuoTrav been studied?
Maltese: Kif ġie studjat DuoTrav?