qanastek/EMEA-V3 huggingface dataset:
The following undesirable effects were assessed to be treatment-related (with TRAVATAN 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 ≤1/1000), or very rare (≤1/10,000).
4 L- effetti mhux mixtieqa li ġejjin kienu stmati li huma relatati mal- kura (b’ monoterapija ta ’ TRAVATAN) u huma klassifikati skond 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) jew rari ħafna (≤1/ 10, 000).
Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
4 Infections and infestations:
Infezzjonijiet u infestazzjonijiet:
Uncommon: herpes simplex
Mhux komuni: herpes simplex
Uncommon: hypersensitivity, seasonal allergy
Mhux komuni: sensittività eċċessiva, allerġija ta ’ l- istaġun
Common: headache Uncommon: dysgeusia
Komuni: uġigħ ta ’ ras Mhux komuni: disġewżja
Very common: conjunctival hyperaemia, ocular hyperaemia Common: punctate keratitis, anterior chamber cell, anterior chamber flare, eye pain, photophobia, eye discharge, ocular discomfort, eye irritation, abnormal sensation in eye, foreign body sensation in eyes, visual acuity reduced, vision blurred, dry eye, eye pruritus, lacrimation increased, erythaema of eyelid, eyelid oedema, eyelids pruritis, growth of eyelashes, iris hyperpigmentation, eyelash discolouration Uncommon: corneal erosion, iridocyclitis, iritis, uveitis, visual field defect, keratitis, anterior chamber inflammation, eye swelling, corneal staining, photopsia, blepharitis, conjunctival oedema, conjunctivitis allergic, conjunctival disorder, conjunctivitis, conjunctival follicles, hypoaesthesia eye, ectropion, keratoconjunctivitis sicca, madarosis, cataract, eye allergy, eyelid pain, eyelid disorder, eyelid margin crusting, scleral hyperaemia, asthenopia
Komuni ħafna: iperimija konġuntivali, iperimija ta ’ l- għajn Komuni: keratite bil- ponot, ċelluli fil- kompartiment anterjuri, riflessjoni ta ’ dawl fil - kompartiment anterjuri, uġigħ fl- għajn, fotofobija, tnixxija mill- għajn, skomdu fl- għajn, irritazzjoni fl- għajn, sensazzjoni mhux normali fl- għajn, sensazzjoni ta ’ oġġett barrani fl- għajn, akutezza tal- vista mnaqqsa, vista mċajpra, għajn tinħass xotta, ħakk fl- għajn, żjieda fid- dmugħ, eritema tal- kappell ta ’ l- għajn, edima fil- kappell ta ’ l- għajn, ħakk fil- kappell ta ’ l- għajn, tkabbir tax- xagħar tal- għajnejn, iperpigmentazzjoni tal- ħabba ta ’ l- għajn, bidla fil- kulur tax- xagħar tal - għajnejn
Uncommon: heart rate irregular, palpitations, heart rate decreased
Mhux komuni: rata ta ’ taħbit tal- qalb irregolari, palpitazzjonijiet, rata ta ’ taħbit tal- qalb imnaqqsa
Uncommon: blood pressure decreased, blood pressure increased, hypotension
Mhux komuni: tnaqqis fil- pressjoni tad- demm, żjieda fil- pressjoni tad- demm, pressjoni baxxa
Uncommon: dysponea, asthma, respiratory disorder, pharyngolaryngeal pain, cough, dysphonia, nasal congestion, throat irritation
Mhux komuni: qtugħ ta ’ nifs, ażżma, disturb fir- respirazzjoni, uġigħ fil- farinġi u fil- larinġi, sogħla, disfonija, konġestjoni fl- imnieħer, irritazzjoni fil- griżmejn
Uncommon: peptic ulcer reactivated, gastrointestinal disorder, constipation
Mhux komuni: riattivazzjoni ta ’ ulċera peptika, disturb gastro- intestinali, stitikezza
Common: skin hyperpigmentation (periocular) Uncommon: dermatitis allergic, periorbital oedema, dermatitis contact, erythaema, hair colour changes, hair texture abnormal, hypertrichosis
Komuni: iperpigmentazzjoni tal- ġilda (madwar l- għajn) Mhux komuni: dermatite allerġika, edima madwar l- għajn, dermatite tal- kuntatt, eritema, bidla fil- kulur tax- xagħar, ix- xagħar jinħass mhux normali, tkabbir eċċessiv ta ’ xagħar
Musculoskeletal, connective tissue and bone disorders:
Disturbi muskolu- skeltrali, tal- connective tissue u tal- għadam:
Uncommon: shoulder pain
Mhux komuni: uġigħ fl- ispalla
General disorders and administrative site conditions:
5 Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata:
Uncommon: asthenia, malaise
Mhux komuni: astenja, telqa
Adverse reactions identified from post-marketing experience that have not been reported previously in clinical trials with TRAVATAN as monotherapy include the following.
Reazzjonijiet avversi identifikati mill- esperjenza ta ’ wara t- tqegħid fis- suq li ma kienux irrapportati qabel fil- provi kliniċi bi TRAVATAN bħala monoterapija jinkludu li ġejjin.
Ocular: macular oedema (see also section 4.4) Systemic: bradycardia, tachycardia, asthma aggravated, vertigo, tinnitus, PSA increased, hair growth abnormal.
Għajnejn: edima makulari (ara wkoll sezzjoni 4. 4) Sistemiċi: bradikardija, takikardija, ażżma tiggrava, vertigo, żanżin fil- widnejn, żjieda fil- PSA, tkabbir tax- xagħar mhux normali.
Ophthalmologicals – antiglaucoma preparations and miotics – prostaglandin analogues ATC code:
Kodiċi ATC:
Mechanism of action Travoprost, a prostaglandin F2α 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.
Travoprost, analogu ta ’ prostaglandin F2α, huwa agonist komplut li huwa selettiv ħafna u għandu affinita għolja għar- riċettur FP ta ’ prostaglandin u jnaqqas il- pressjoni fl- għajn billi jżid il- ħruġ ta ’ l - aqueous humour mix- xibka trabekulari u r- rotot uveosklerali.
Reduction of the intraocular pressure in man starts about 2 hours after administration and maximum effect is reached after 12 hours.
Fil- bniedem, tnaqqis tal- pressjoni fl - għajnejn jibda madwar sagħtejn wara l- għoti u l- effett massimu jintlaħaq wara 12- il siegħa.
Significant lowering of intraocular pressure can be maintained for periods exceeding 24 hours with a single dose.
Tnaqqis sostanzjali fil- pressjoni tal- għajn jista ’ jinżam għall- perijodu ta ’ aktar minn 24 siegħa b’ doża waħda.
Data on adjunctive administration of TRAVATAN with timolol 0.5% and limited data with brimonidine 0.2% were collected during clinical trials that showed an additive effect of TRAVATAN with these glaucoma medications.
Tagħrif dwar l- għoti ta ’ TRAVATAN flimkien ma ’ 0. 5% timolol u tagħrif limitat dwar l- użu ta ’ TRAVATAN ma ’ 0. 2% brimonidine kien miġbur waqt provi kliniċi li wrew effett addittiv ta ’ TRAVATAN ma ’ dawn il- mediċini għall- kura tal- glawkoma.
No clinical data are available on adjunctive use with other ocular hypotensive medications.
M’ hemm l- ebda tagħrif kliniku dwar l - użu ma ’ mediċini oħra li jnaqqsu il- pressjoni tal- għajn.
Secondary pharmacology Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of topical ocular administration (1.4 micrograms, once-daily)
Farmakoloġija sekondarja Wara 7 ijiem ta ’ għoti topiku fl- għajn (1. 4 mikrogrammi, darba kuljum), Travoprost żied b’ mod sinifikanti ċ- ċirkolazzjoni tad- demm lejn ir- ras tan- nerv ottiku fil- fniek.
Absorption Travoprost is an ester prodrug.
Assorbiment Travoprost huwa ester prodrug.
It is absorbed through the cornea where the isopropyl ester is hydrolysed to the active free acid.
Jiġi assorbit minn ġol- korneja fejn l- isopropyl ester jiġi idrolizzat f’ aċidu ħieles attiv.
Studies in rabbits have shown peak concentrations of 20 ng/ g of the free acid in aqueous humour one to two hours after topical dosing of TRAVATAN.
Studji fil- fniek urew konċentrazzjonijiet massimi ta ’ 20 ng/ g ta ’ l- aċidu ħieles fl - aqueous humour siegħa sa sagħtejn wara l- għoti topiku ta ’ TRAVATAN.
Aqueous humour concentrations declined with a half-life of approximately 1.5 hours.
Konċentrazzjonijiet fl - aqueous humour naqsu b’ half life ta ’ bejn wieħed u ieħor 1. 5 sigħat.
Distribution Following topical ocular administration of TRAVATAN to healthy volunteers, low systemic exposure to active free acid was demonstrated.
6 Distribuzzjoni Wara li TRAVATAN ingħata b’ mod topiku, fl- għajnejn lill- voluntiera b’ saħħithom, kien dimostrat esponiment sistemiku baxx għall- aċidu ħieles attiv.
Peak active free acid plasma concentrations of 25 pg/ ml or less were observed between 10 and 30 minutes post-dose.
Konċentrazzjonijiet massimi ta ’ aċidu ħieles attiv fil- plażma ta ’ 25 pg/ ml jew inqas kienu osservati minn 10 minuti sa 30 minuta wara li ngħatat id- doża.
Thereafter, plasma levels declined rapidly to below the 10 pg/ ml assay quantitation limit before 1 hour post-administration.
Wara dan, f’ inqas minn siegħa wara l- għoti, l- livelli fil- plażma naqsu b’ mod rapidu għal inqas minn 10 pg/ ml; il- limitu li jista ’ jiġi kwantifikat b' analiżi.
Due to the low plasma concentrations and rapid elimination following topical dosing, the elimination half-life of active free acid in man could not be determined.
Minħabba l- konċentrazzjonijiet baxxi fil- plażma u l- eliminazzjoni rapida wara l- għoti topiku, l- half life ta ’ l- eliminazzjoni ta ’ l- aċidu ħieles attiv fil - bniedem ma jistax jiġi determinat.
Metabolism Metabolism is the major route of elimination of both travoprost and the active free acid.
Metaboliżmu Metaboliżmu huwa r- rotta ewlenija tal- eliminazzjoni kemm għal Travoprost kif ukoll għall- aċidu ħieles attiv.
The systemic metabolic pathways parallel those of endogenous prostaglandin F2α which are characterised by reduction of the 13-14 double bond, oxidation of the 15-hydroxyl and β -oxidative cleavages of the upper side chain.
Ir- rotot metaboliċi fil- ġisem jixbhu lil dawk ta ’ prostaglandin F2α endoġenu u huma kkaratterizzati minn tnaqqis tad- double bond 13- 14, u ossidazzjoni tal- qsim 15- hydroxy u β- oxidative tal- katina tat- tarf tan- naħa ta ’ fuq.
Excretion Travoprost free acid and its metabolites are mainly excreted by the kidneys.
Tneħħija L- aċidu ħieles ta ’ travoprost u l- metaboliti tiegħu jiġu mneħħija fil- biċċa l- kbira mill- kliewi.
TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/ min).
TRAVATAN kien studjat f’ pazjenti b’ indeboliment ħafif sa sever tal- fwied u f’ pazjenti b’ indeboliment ħafif sa sever tal- kliewi (tneħħija tal- krejatinina b’ livell baxx sa 14 ml/ min).
In ocular toxicity studies in monkeys, administration of travoprost at a dose of 0.45 microgram, twice a day, was shown to induce increased palpebral fissure.
Fi studji dwar l- effett tossiku fuq l- għajnejn fix- xadinin, l- għoti ta ’ doża ta ’ 0. 45 mikrogramma ta ’ travoprost, darbtejn kuljum intwera li jikkawża żjieda fil- fetħa tal- palpebra.
Topical ocular administration of travoprost to monkeys at concentrations of up to 0.012% to the right eye, twice daily for one year resulted in no systemic toxicity.
L- għoti ta ’ travoprost b’ mod topiku fl- għajnejn lix- xadini, f’ konċentrazzjonijiet sa 0. 012% ġo l- għajn il- leminija, darbtejn kuljum għal sena, ma rriżultax f’ tossiċità sistemika.
Reproduction toxicity studies have been undertaken in rat, mice and rabbit by systemic route.
Saru studji dwar l- effett tossiku fuq is- sistema riproduttiva, fil- firien, ġrieden u fniek b’ għoti sistemiku.
Findings are related to FP receptor agonist activity in uterus with early embryolethality, post-implantation loss, foetotoxicity.
Is- sejbiet huma relatati ma ’ l- attivita ’ agonista tar- riċettur FP ġewwa l- uteru u kien hemm mewt bikri tal- embriju, telf tal- embriju wara li ġie impjantat u effett tossiku fuq il- fetu.
Low levels of radioactivity were measured in amniotic fluid and foetal tissues of pregnant rats administered 3H-travoprost.
F’ firien tqal li ngħataw 3H - travoprost, kienu mkejla livelli baxxi ta ’ radjuattività fil- fluwidu amnijotiku u fit- tessuti tal- fetu.
Benzalkonium chloride Polyoxyethylene hydrogenated castor oil 40 (HCO-40) Trometamol Disodium edetate Boric acid (E284) Mannitol (E421) Sodium hydroxide and/ or hydrochloric acid (to adjust pH) Purified water
Benzalkonium chloride Polyoxyethylene hydrogenated castor oil 40 (HCO- 40) Trometamol Disodium edetate Boric acid (E284) Mannitol (E421) Sodium hydroxide u/ jew hydochloric acid (għall- aġġustament tal- pH) Ilma ppurifikat
None known.
Xejn magħrufa.
Specific in vitro interaction studies were performed with TRAVATAN and medicinal products containing thiomersal.
Saru studji speċifici in vitro dwar l- interazzjonijiet bi TRAVATAN u prodotti mediċinali li fihom thiomersal.
No evidence of precipitation was observed.
Ma kien osservat l- ebda evidenza ta ’ preċipitazzjoni.
2.5 ml oval bottle with dispensing plug and screw cap, all polypropylene, presented in an overwrap.
Flixkun ovali ta ’ 2. 5 ml b’ tapp għall- għoti u b’ għatu bil- kamin, kollox magħmul minn polypropylene; ippreżentat f’ pakkett ta ’ protezzjoni.
Cartons containing 1 or 3 bottles.
Kaxxa li fiha flixkun wieħed jew 3 flixken.
Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom.
Boundary Way Hemel Hempstead Herts HP2 7UD Ir- Renju Unit.
Date of first authorisation :27.11.2001 Date of last renewal:
27. 11. 2001 Data tal- aħħar tiġdid:
Not Applicable
Ma jgħoddx f’ dan il- każ
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR SINGLE BOTTLE 2.5 ml + CARTON FOR 3x2.5 ml BOTTLES
KARTUNA TA ’ FLIXKUN WIEĦED ta ’ 2. 5 ml + KARTUNA TA ’ 3FLIXKEN ta ’ 2. 5 ml
TRAVATAN 40 micrograms/ ml eye drops, solution travoprost
TRAVATAN 40 mikrogramma/ ml, qtar għall- għajnejn, soluzzjoni. travoprost
1 ml of solution contains 40 micrograms of travoprost
Ml ta ’ soluzzjoni fih 40 mikrogramma travoprost
Benzalkonium chloride, polyoxyethylene hydrogenated castor oil 40 (HCO-40), trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide and/ or hydrochloric acid (to adjust pH) and purified water.
Benzalkonium chloride, polyoxyethylene hydrogenated castor oil 40 (HCO- 40), trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide u/ jew hydrochloric acid (għall- aġġustament tal- pH), ilma ppurifikat.
See the package leaflet for further details.
Ara il- fuljett ta ’ tagħrif għal aktar dettalji.
Eye drops, solution 1 x 2.5 ml 3 x 2.5 ml
Qtar għall- għajnejn, soluzzjoni 1 x 2. 5 ml 3 x 2. 5 ml
Opened (2) Opened (3)
Infetaħ (3):
10 SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
EU/ 1/ 01/ 199/ 001 1 x 2.5 ml EU/ 1/ 01/ 199/ 002 3x 2.5 ml
EU/ 1/ 01/ 199/ 001 1 x 2. 5 ml EU/ 1/ 01/ 199/ 002 3x 2. 5 ml
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14 TAGHRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TRAVATAN 40 micrograms/ ml eye drops,. travoprost
TRAVATAN 40 mikrogramma/ ml qtar għall- għajnejn. travoprost
Read the package leaflet before use .< For further information pull up label at arrow >
Aqra il- fuljett ta ’ tagħrif qabel l- użu. < Għal aktar tagħrif qaxxar it- tikketta fejn immarkat >
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS OVERWRAP
15 TAGHRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TRAVATAN 40 micrograms/ ml eye drops, solution. travoprost
TRAVATAN 40 mikrogramma/ ml qtar għall- għajnejn, soluzzjoni. travoprost
TRAVATAN 40 micrograms/ ml eye drops, solution Travoprost
TRAVATAN 40 mikrogramma/ ml qtar għall- għajnejn, soluzzjoni Travoprost
If you have any further questions after reading it, please ask your doctor or your pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them, even if their symptoms are the same as yours
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
If any of the side effects gets serious, or if you notice any sided effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
WHAT TRAVATAN DOES
X’ INHU TRAVATAN U GĦALXIEX JINTUŻA
TRAVATAN eye drops are used to treat high pressure in the eye.
TRAVATAN qtar għall- għajnejn jintuża għal kura ta ’ pressjoni għolja fl- għajn.
Liquid is always emptying out of the eye, and more liquid is always being produced.
Il- likwidu dejjem qed jitbattal barra mill- għajn, u aktar likwidu qed jiġi magħmul kontinwament.
If it gets too high, it can damage your sight.
Jekk din togħla wisq, tista ’ tagħmel ħsara lill- vista tiegħek.
TRAVATAN is one of a group of medicines for glaucoma called prostaglandin analogues.
TRAVATAN huwa wieħed minn grupp ta ’ mediċini għall- kura tal- glawkoma li jissejħu analogi ta ’ prostaglandin.
It works by increasing the outflow of liquid, which lowers the pressure in the eye.
Jaħdem billi jżid il- ħruġ ta ’ likwidu mill- għajn u b’ hekk ibaxxi l- pressjoni fl- għajn.
It may be used on its own or with other drops e. g. beta-blockers, which also reduce pressure.
Jista ’ jintuża waħdu jew flimkien ma ’ qtar ieħor e. ż. imblokkaturi tar- riċetturi Beta, li wkoll inaqqsu l - pressjoni.
BEFORE YOU USE TRAVATAN
QABEL MA ’ TUŻA TRAVATAN
Do not use TRAVATAN. • if you are allergic to travoprost or any of the other ingredients of TRAVATAN.
Tużax TRAVATAN. • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal travoprost jew sustanzi oħra ta ’ TRAVATAN.
Ask your doctor for advice if this applies to you.
Jekk dan japlika għalik, staqsi lit- tabib tiegħek għall- parir.
Take special care
Oqgħod attent ħafna
TRAVATAN is not to be used by people under 18 years of age.
TRAVATAN m’ għandux jintuża minn persuni taħt 18- il sena.
• TRAVATAN may increase the length, thickness, colour and/ or number of your eyelashes and may cause unusual hair growth on your eyelids.
• TRAVATAN jista ’ jżid it- tul, il- ħxuna, il- kulur u/ jew in- numru ta ’ xagħar ta ’ l- għajnejn u jista ’ jikkawża tkabbir ta ’ xagħar mhux tas- soltu fuq il- kappell tal- għajn.
• TRAVATAN may change the colour of your iris (the coloured part of your eye).
• TRAVATAN jista ’ jbiddel il- kulur tal- ħabba ta ’ għajnejk (il- parti kkulurita ta ’ għajnejk).
This change may be permanent.
Din il- bidla tista tkun permanenti.
• TRAVATAN may rarely cause breathlessness or wheezing or increase the symptoms of asthma.
• TRAVATAN, f’ każijiet rari, jista ’ jikkawża, qtugħ ta ’ nifs jew tħarħir, jew iżid is- sintomi ta ’ l - ażżma.
If you are concerned about changes in your breathing pattern when using TRAVATAN advise your doctor as soon as possible.
Jekk qed tinkwieta dwar bidliet fin- nifs meta tuża TRAVATAN, għid lit- tabib tiegħek malajr kemm jista ’ jkun.
18 Using other medicines
18 • Travoprost jista ’ jiġi asorbit mill- ġilda u għalhekk m’ għandux jintuża min- nisa tqal jew li qed jippruvaw joħorġu tqal.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Do not use TRAVATAN if you are pregnant.
Tużax TRAVATAN jekk inti tqila.
If you think that you may be pregnant speak with your doctor right away.
Jekk taħseb li tista ’ tkun tqila kellem lit- tabib tiegħek minnufih.
If you could become pregnant you must use adequate contraception whilst you use TRAVATAN.
Jekk tista ’ toħroġ tqila, għandek tuża kontraċezzjoni adegwata waqt li qed tuża TRAVATAN.
Do not take TRAVATAN if you are breast feeding, TRAVATAN may get into your milk.
Tużax TRAVATAN jekk qed tredda ’, għax TRAVATAN jista ’ joħroġ fil- ħalib tiegħek.
Ask your doctor for advice before taking any medicine
Itlob il- parir tat- tabib tiegħek qabel tieħu xi mediċina
You may find that your vision is blurred for a time just after you use TRAVATAN.
Għandek mnejn issib li l- vista tiegħek tkun imċajpra għal xi ħin hekk kif tuża TRAVATAN.
Important information about some of the ingredients • If you wear soft contact lenses.
Tagħrif importanti dwar xi wħud mis- sustanzi • Jekk tuża lentijiet tal- kuntatt rotob.
Don’ t use the drops with your lenses in.
Tużax il- qtar waqt li liebes il- lentijiet tal- kuntatt.
Wait 15 minutes after using the drops before putting your lenses back in.
Stenna 15- il minuta wara li tuża l- qtar qabel tilbes il- lentijiet tal- kuntatt mill- ġdid.
There is a preservative in TRAVATAN (benzalkonium chloride) that can discolour soft lenses. • TRAVATAN contains hydrogenated castor oil, which may cause skin reactions.
Hemm preservattiv ġo TRAVATAN (benzalkonium chloride) li jista ’ jbiddel il- kulur tal- lentijiet tal- kuntatt rotob. • TRAVATAN fih hydrogenated castor oil li jista ’ jikkawża reazzjonijiet fil- ġilda.
HOW TO USE TRAVATAN
KIF GĦANDEK TUŻA TRAVATAN
Always use TRAVATAN exactly as your doctor has told you.
Dejjem għandek tuża TRAVATAN skond il- parir eżatt tat- tabib.
Check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubji.
The usual dose
Id- doża li ssoltu tingħata
1 drop in the eye or eyes, once a day – in the evening.
Qatra waħda ġo l- għajn jew għajnejn, darba kuljum- filgħaxija.
Only use TRAVATAN in both eyes if your doctor told you to.
Uża TRAVATAN f’ għajnejk it- tnejn biss, jekk qallek it- tabib tiegħek.
Take it for as long as your doctor told you to.
Uża għat- tul ta ’ żmien li qallek it- tabib tiegħek.
Only use TRAVATAN for dropping in your eyes.
Uża TRAVATAN biex tqattar f’ għajnejk biss.
TURN THE PAGE FOR MORE ADVICE
AQLEB IL- PAĠNA GĦALL- AKTAR TAGĦRIF
HOW TO USE TRAVATAN (continued)
KIF GĦANDEK TUŻA TRAVATAN (ikompli)
• Immediately before using a bottle for the first time, tear-off the overwrap pouch take it out (picture 1) and write the date of opening on the label in the space provided • Get the TRAVATAN bottle and a mirror • Wash your hands • Twist off the cap • Hold the bottle, pointing down, between your thumb and fingers • Tilt your head back.
• Eżatt qabel ma ’ tuża l- flixkun għall- ewwel darba, iftaħ il- pakkett ta ’ protezzjoni, oħroġ il - flixkun (stampa 1) u ikteb id- data ta ’ meta ftaħt il- pakkett fuq it- tikketta fl- ispazju pprovdut • Aqbad il- flixkun ta ’ TRAVATAN u mera • Aħsel idejk • Neħħi l- għatu tal- flixkun • Żomm il- flixkun wiċċu ’ l isfel bejn subgħajk il- kbir u s- swaba l- oħra • Itfa rasek lura.
Pull down your eyelid with a clean finger, until there is a ‘ pocket’ between the eyelid and your eye.
B’ seba ’ nadif, niżżel il- kappell ta ’ għajnejk sakemm ikun hemm ‘ spazju ’ bejn il - kappell t’ għajnejk u l- għajn tiegħek.
It could infect the drops • Gently squeeze the bottle to release one drop of TRAVATAN at a time.
Jekk jgħin uża l- mera • Tmisx għajnejk jew il- kappell ta ’ l- għajn, il- postijiet tal- madwar jew superfiċji oħra bil - qattara tal- flixkun.
(picture 3) • After using TRAVATAN, press a finger into the corner of your eye, by the nose (picture 4).
Dan jista ’ jikkontamina l- qtar • Agħfas il- flixkun bil- mod biex tinżel qatra waħda ta ’ TRAVATAN kull darba (stampa 3) • Wara li tuża TRAVATAN, agħfas b’ subgħajk il- kantuniera ta ’ għajnejk, in- naħa ta ’ l- imnieħer (stampa 4).
This helps to stop TRAVATAN getting into the rest of the body • If you take drops in both eyes, repeat the steps for your other eye • Close the bottle cap firmly immediately after use • Only use one bottle at a time.
Dan jgħin biex iwaqqaf lil TRAVATAN milli jidħol fil- bqija tal- ġisem. • Jekk tuża l- qtar f’ għajnejk it- tnejn, irrepetiti l- proċedura għal l- għajn l- oħra. • Agħlaq sew l- għatu tal- flixkun immedjatament wara l- użu • Uża flixkun wieħed biss qabel ma tiftaħ ieħor.
If you use more TRAVATAN than you should, rinse it all out with warm water.
Jekk tuża TRAVATAN aktar milli suppost, laħlaħ b’ ilma sħun.
Don’ t put in any more drops until it’ s time for your next regular dose.
Tużax aktar qtar qabel isir il- ħin għad- doża tas- soltu li jmiss.
If you forget to use TRAVATAN, continue with the next dose as planned.
Jekk tinsa tuża TRAVATAN, kompli bid- doża li jmiss kif ippjanat.
Do not use a double dose to make up.
M’ għandekx tuża doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using TRAVATAN without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.
Jekk tieqaf tuża TRAVATAN mingħajr ma tkellem lit- tabib tiegħek, il- pressjoni ġewwa għajnejk ma tkunx ikkontrollata u dan jista ’ jwassal għal telf tal- vista.
If you are using other eye drops, leave at least 5 minutes between putting in TRAVATAN and the other drops.
Jekk qed tuża qtar għall- għajnejn ieħor, stenna mill- inqas 5 minuti bejn l- użu ta ’ TRAVATAN u l - qtar l- ieħor.
If you have any further questionson the use of this product ask a doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, TRAVATAN can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, TRAVATAN jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you’ re worried, talk to a doctor or pharmacist.
Jekk qed tinkwieta, kellem tabib jew spiżjar.
Do not stop taking TRAVATAN without speaking to your doctor.
Twaqqafx l- uża ta ’ TRAVATAN mingħajr ma tkellem lit- tabib tiegħek.
Very common side effects This may affect up to 23 in every 100 people 20 Redness of the eye
Effetti sekondarji komuni ħafna Dawn jistgħu jaffettwaw sa 23 persuna minn kull 100
Common side effects This may affect up to 10 in every 100 people
Effetti sekondarji komuni Dawn jistgħu jaffettwaw sa 10 persuni minn kull 100
Effects in the eye: inflammation inside the eye, eye pain or swelling, eye irritation, eye discharge, sensitivity to light, blurred, reduced or abnormal vision, dry eye, itchy eye, increased tear production, abnormal or decreased eye sensation; eyelid abnormality, irritation, itching, redness, pain, swelling or crusting; discolouration of the eyelashes, increased or decreased growth or number of eyelashes, changes in the colour of the iris.
Effetti fl- għajn: infjammazzjoni ġewwa l- għajn, uġigħ jew nefħa fl- għajn, irritazzjoni fl- għajn, tnixxija mill- għajn, sensittività għad- dawl, vista mċajpra, imnaqqsa jew mhux normali, għajn tinħass xotta, ħakk fl- għajn, żjieda fid- dmugħ, sensazzjoni mhux normali jew imnaqqsa fl- għajn; anormalità, irritazzjoni, ħakk, ħmura, uġigħ, nefħa jew qoxra fil- kappell ta ’ l- għajn; bidla fil- kulur tax- xagħar tal - għajnejn, żjieda jew tnaqqis fit- tkabbir jew numru ta ’ xagħar tal- għajnejn, bidla fil- kulur tal- ħabba tal - għajn.
Effects in the body: headache, skin darkening around the eyes.
Effetti fil- ġisem: uġigħ ta ’ ras, il- ġilda ta ’ madwar l- għajnejn tiskura.
Uncommon side effects This may affect up to 1 in every 100 people
Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa persuna waħda minn kull 100
Effects in the eye: inflammation or infection of the conjunctiva, corneal disorder, eye allergy, tired eyes.
Effetti fl- għajn: infjammazzjoni jew infezzjoni tal- konġuntiva, disturb fil- korneja, allerġija fl- għajn, għeja fl- għajnejn.
Effects in the body: asthma, shortness of breath, increased or decreased blood pressure, irregular, increased, or decreased heart rate, viral infection, cough, generalised weakness, increased allergic symptoms, throat irritation, stuffy nose, voice changes, gastrointestinal discomfort or ulcer, constipation, skin inflammation, redness or itching, shoulder pain, bad taste.
Effetti fil- ġisem: ażżma, qtugħ ta ’ nifs, żjieda jew tnaqqis fil- pressjoni tad- demm, rata ta ’ taħbit tal - qalb irregolari, miżjuda, jew imnaqqsa, infezzjoni kkawżata minn virus, sogħla, debbulizza ġeneralizzata, żjieda fis- sintomi ta ’ allerġija, irritazzjoni fil- griżmejn, imnieħer misdud, bidliet fil- vuċi, skomdu jew ulċera gastro- intestinali, stitikezza, infjammazzjoni fil- ġilda, ħmura jew ħakk, uġigħ fl - ispalla, togħma ħażina.
Additional side effects that have been reported include:
Effetti sekondarji oħra li ġew irrapportati jinkludu:
Effects in the eye: inflammation of the back of the eye.
Effetti fl- għajn: infjammazzjoni fin- naħa ta ’ wara ta ’ l- għajn.
Effects in the body worsening of asthma, dizziness, ringing in ears, increased prostate antigen.
Effetti fil- ġisem: ażżma tiggrava, sturdament, żanżin fil- widnejn, żjieda ta ’ prostate antigen.
HOW TO STORE TRAVATAN
KIF TAĦŻEN TRAVATAN
After ‘ Exp’.
Tużax TRAVATAN wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kaxxa wara ‘ Exp ’.
You must throw away the bottle 4 weeks after you first opened it, to prevent infections, and use a new bottle.
21 Għandek tarmi l- flixkun erba ’ ġimgħat wara li tkun ftaħtu l- ewwel darba u tuża flixkun ġdid biex tipprevjeni nfezzjonijiet.
Write down the date you opened it in the space on each bottle label and box.
Ikteb id- data meta ftaħt il- flixkun fl- ispazju fuq kull tikketta tal- flixkun u kaxxa.
Medicines should not be disposed of via wastewater or in household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines you no longer need.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What TRAVATAN contains
X’ fih TRAVATAN
The active substance is travoprost 40 micrograms/ ml.
Is- sustanza attiva hija travoprost 40 mikrogramma/ ml.
21 The other ingredients are:
Is- sustanzi l- oħra huma:
Benzalkonium chloride, polyoxyethylene hydrogenated castor oil 40 (HCO-40), trometamol, disodium edetate, boric acid, mannitol and purified water. Tiny amounts of hydrochloric acid or sodium hydroxide are added to keep acidity levels (pH levels) normal.
Jiġu miżjuda ammonti żgħar ta ’ hydrochloric acid jew sodium hydroxide biex iżommu l- livelli ta ’ l- aċidità (livelli tal- pH) normali.
What TRAVATAN looks like and the contents of the pack TRAVATAN is a liquid (a clear, colourless solution) supplied in a pack containing a 2.5 ml plastic bottle with a screw cap or in a pack containing three 2.5 ml plastic bottles with screw caps.
Id- Dehra ta ’ TRAVATAN u l- kontenuti tal- pakkett TRAVATAN huwa likwidu (soluzzjoni ċara u mingħajr kulur) fornut f’ pakkett li fih flixkun tal - plastik ta ’ 2. 5 ml b’ għatu tal- kamin, jew f’ pakkett li fih tliet flixken tal- plastik ta ’ 2. 5 ml b’ għatu tal - kamin.
Alcon - Couvreur N. V Rijksweg 14 B-2870 Puurs Belgium
Alcon- Couvreur N. V Rijskweg 14 B- 2870 Puurs Il- Belġju
Manufacturer Alcon Cusí, S. A Camil Fabra 58 08320 El Masnou Spain
Alcon Cusí, S. A Camil Fabra 58 08320 El Masnou Spanja
22 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
22 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq.
This leaflet was last approved in XXXXX
Dan il- fuljett kien approvat l- aħħar f’ XX/ SSSS
What is Trazec?
X’ inhu Trazec?
Trazec is a medicine contains the active substance nateglinide.
Trazec huwa mediċina li fiha s- sustanza attiva nateglinide.
What is Trazec used for?
Għalxiex jintuża Trazec?
Trazec is used in patients who have non insulin-dependent diabetes (type 2 diabetes).
Trazec jintuża f’ pazjenti li jkollhom id- dijabete tat- tieni tip mhux dipendenti mill- insulina.
Trazec is used together with metformin (another antidiabetes medicine) to lower blood glucose (sugar) in patients whose diabetes cannot be controlled by metformin alone.
Trazec jintuża flimkien ma ’ metformin (mediċina oħra għal kontra d- dijabete) biex ibaxxi l- livell tal- glucosju fid- demm f’ pazjenti li d- dijabete tagħhom ma tkunx tista ’ tiġi kkontrollata minn metformin waħdu.
How is Trazec used?
Kif jintuża Trazec?
Trazec is given within one to 30 minutes before breakfast, lunch and dinner and the dose is adjusted to give the best control.
Trazec jingħata bejn minuta u 30 minuta qabel il- kolazzjon, l- ikla ta ’ nofsinhar u l- ikla ta ’ filgħaxija u d- doża tiġi aġġustata biex tagħti l- aqwa kontroll.
A doctor should regularly test the patient's blood glucose to find the lowest effective dose.
Il- livell ta ’ zokkor fid- demm tal- pazjent irid jiġi ċċekkjat regolarment minn tabib biex tinstab l- inqas doża li tkun effettiva.
The recommended starting dose is 60 mg three times a day before meals.
Id- doża inizjali rakkomandata hi ta ’ 60 mg tliet darbiet kuljum qabel l- ikliet.
How does Trazec work?
Kif jaħdem Trazec?
Nateglinide, the active ingredient in Trazec, stimulates the pancreas to produce insulin more quickly.
Nateglinide, is- sustanza attiva fi Trazec, jistimula l- frixa biex tipproduċi l - insulina iktar malajr.
How has Trazec been studied?
Kif ġie studjat Trazec?
A total of 2,122 patients received Trazec in all trials combined.
Fl- istudji kollha b’ kollox kien hemm 2, 122 pazjent li ngħataw Trazec.
The main studies compared Trazec to placebo (a dummy treatment), or to other medicines used in type 2 diabetes (metformin, glibenclamide or troglitazone).
L- istudji ewlenin qabblu Trazec ma ’ plaċebo (trattament finta), jew ma ’ mediċini oħra użati fid- dijabete tat- tieni tip (metformin, glibenclamide jew troglitazone).
Other studies also looked at ‘ switching ’ from an antidiabetes medicine to Trazec, and ‘ adding’ Trazec to other antidiabetes medicines.
Studji oħra studjaw ukoll ‘ il- qlib ’ minn mediċini antidijabetiċi għal Trazec, u ‘ ż- żieda ’ ta ’ Trazec ma ’ mediċini antidijabetiċi oħra.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Trazec shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ inhu l- benefiċċju ta ’ Trazec li ntwera f’ dawn l- istudji?
On its own, Trazec was shown to be more effective than placebo, but less effective than some antidiabetes medicines such as metformin.
Intwera li Trazec waħdu kien iktar effettiv mill- plaċebo, iżda inqas effettiv minn xi mediċini antidijabetiċi oħra bħal metformin.
In combination with metformin, which mainly affected fasting plasma glucose (the amount of glucose in the blood when the person has not eaten anything), the effect of Trazec on HbA1c was better than either medicine alone.
Flimkien ma ’ metformin, li jaffettwa l- aktar il- glucosju fil- plażma meta wieħed ikun sajjem (l- ammont ta ’ glucosju fid- demm meta l- persuna ma tkun kielet xejn), l - effett ta ’ Trazec fuq l- HbA1c kien aħjar minn kwalunkwe mill- mediċini weħidhom.
What is the risk associated with Trazec?
X’ inhu r- riskju assoċjat ma ’ Trazec?
Trazec may in some cases cause hypoglycaemia (low blood glucose).
Trazec f’ xi każi jista ’ jikkawża ipogliċemija (livell baxx ta ’ glucosju fid- demm).
For the full list of all side effects reported with Trazec, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurtati bi Trazec, ara l- Fuljett ta ’ Tagħrif.
Trazec should not be used in people who may be hypersensitive (allergic) to nateglinide or any of the other ingredients, who have type 1 diabetes, a severe liver problem, or who have diabetic ketoacidosis (a serious complication of diabetes).
Trazec m’ għandux jintuża minn persuni li huma allerġiċi għal nateglinide jew għal xi sustanzi oħra tiegħu, li jkollhom id- dijabete ta ’ l- ewwel tip jew problema severa fil- fwied, jew li jkollhom ketoaċidożi dijabetika (kumplikazzjoni serja tad- dijabete).
Trazec doses might also need to be adjusted when given with some medicines used in heart conditions, to treat pain, to treat asthma, and other conditions.
Id- doża ta ’ Trazec tista ’ wkoll tiġi aġġustata meta tingħata ma ’ xi mediċini użati għall- kundizzjonijiet tal- qalb, biex jittrattaw l- uġigħ, biex jittrattaw l- ażma, u kundizzjonijiet oħra.
Why has Trazec been approved?
Għaliex ġie approvat Trazec?
The Committee for Medicinal products for Human Use (CHMP) decided that Trazec’ s benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Trazec huma ikbar mir- riskji tiegħu fit- trattament tad- dijabete tat- tieni tip, flimkien ma ’ metformin, f’ pazjenti li ma jkunux ikkontrollati minkejja li jkunu qed jingħataw id- doża massima ta ’ metformin.
The Committee recommended that Trazec be given marketing authorisation.
Il- Kumitat irrakkomanda li Trazec jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Trazec:
Tagħrif ieħor dwar Trazec:
The European Commission granted a marketing authorisation valid throughout the European Union, for Trazec to Novartis Europharm Limited on 3 April 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Trazec lil Novartis Europharm Limited fit- 3 ta ’ April 2001.
The full EPAR for Trazec is available here.
L- EPAR sħiħ għal Trazec huwa disponibbli minn hawnhekk.
EU Number EU/ 1/ 01/ 175/ 001 EU/ 1/ 01/ 175/ 004 EU/ 1/ 01/ 175/ 005 EU/ 1/ 01/ 175/ 006 EU/ 1/ 01/ 175/ 007 EU/ 1/ 01/ 175/ 008 EU/ 1/ 01/ 175/ 011 EU/ 1/ 01/ 175/ 012 EU/ 1/ 01/ 175/ 013 EU/ 1/ 01/ 175/ 014 EU/ 1/ 01/ 175/ 015 EU/ 1/ 01/ 175/ 018 EU/ 1/ 01/ 175/ 019 EU/ 1/ 01/ 175/ 020 EU/ 1/ 01/ 175/ 021
Numru ta ’ l- EU EU/ 1/ 01/ 175/ 001 EU/ 1/ 01/ 175/ 004 EU/ 1/ 01/ 175/ 005 EU/ 1/ 01/ 175/ 006 EU/ 1/ 01/ 175/ 007 EU/ 1/ 01/ 175/ 008 EU/ 1/ 01/ 175/ 011 EU/ 1/ 01/ 175/ 012 EU/ 1/ 01/ 175/ 013 EU/ 1/ 01/ 175/ 014 EU/ 1/ 01/ 175/ 015 EU/ 1/ 01/ 175/ 018 EU/ 1/ 01/ 175/ 019 EU/ 1/ 01/ 175/ 020 EU/ 1/ 01/ 175/ 021
Invented name Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec
Isem inventat Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec Trazec
Strength 60 mg 60 mg 60 mg 60 mg 60 mg 120 mg 120 mg 120 mg 120 mg 120 mg 180 mg 180 mg 180 mg 180 mg 180 mg
Qawwa 60 mg 60 mg 60 mg 60 mg 60 mg 120 mg 120 mg 120 mg 120 mg 120 mg 180 mg 180 mg 180 mg 180 mg 180 mg
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Għamla farmaċewtika Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu) blister (PVC/ PE/ PVDC/ alu)
Il- pakkett folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu) folja (PVC/ PE/ PVDC/ alu)
Package size 12 tablets 60 tablets 84 tablets 120 tablets 360 tablets 12 tablets 60 tablets 84 tablets 120 tablets 360 tablets 12 tablets 60 tablets 84 tablets 120 tablets 360 tablets
Daqs tal- pakkett 12- il pillola 60 pillola 84 pillola 120 pillola 360 pillola 12- il pillola 60 pillola 84 pillola 120 pillola 360 pillola 12- il pillola 60 pillola 84 pillola 120 pillola 360 pillola
TRAZEC 60 mg film-coated tablets
TRAZEC 60 mg pilloli miksijin b’ rita
60 mg pink, round, bevelled-edge tablets with “ NVR” marked on one side and “ TS” on the other.
Pilloli b’ 60 mg, roża, tondi, b’ xifer imżerżaq b ’ “ NVR ” immarkat fuq naħa u “ TS ” fuq l- oħra.
Since the primary therapeutic effect of Trazec is to reduce mealtime glucose, (a contributor to HbA1c), the therapeutic response to Trazec may also be monitored with 1– 2 hour post-meal glucose.
Tibdil fid- doża għandu jkun ibbażat fuq il- kejl perjodiku tal- ħemoglobina glikożilata (HbA1c) Minħabba illi l- effett ewlieni ta ’ Trazec huwa li jnaqqas glucose li jiġi mill- ikel, (li jikkawża HbA1c), ir- rispons terapewtiku għal Trazec jista ’ jkun monitorat mill- ammont ta ’ glucose li jkun hemm bejn siegħa- sagħtejn wara l- ikel.
Trazec is contraindicated in patients with: • Hypersensitivity to the active substance or to any of the excipients • Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative) • Diabetic ketoacidosis, with or without coma • Pregnancy and breast-feeding (see section 4.6) • Severe hepatic impairment
Trazec huwa kontra- indikat f’ pazjenti b ’: • Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. • Dijabete Tip 1 (Dijabete mellitus dipendenti fuq l- insulina, C- peptajd negattiv) • Ketoaċidożi tad- dijabete, b’ koma jew mingħajrha • Tqala u treddigħ (ara sezzjoni 4. 6) • Impediment epatiku sever
Trazec contains lactose monohydrate.
Trazec fih lactose monohydrate.
Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are CYP2C9 or CYP3A4 substrates upon coadministration with Trazec.
Għalhekk, m’ hemmx bżonn ta ’ tibdil fid- doża għal digoxin, warfarin u mediċini oħra li huma sottostrati ta ’ CYP 2C9 u CYP 3A4 meta jingħataw ma ’ Trazec.
Similarly, there was no clinically significant pharmacokinetic interaction of Trazec with other oral antidiabetic agents such as metformin or glibenclamide.
Bl- istess modd ma kellha l- ebda effett kliniku sinifikanti l- interazzjoni farmakokinetika ta ’ Trazec ma ’ aġenti antidijabetici li jittieħdu mill- ħalq bħal metformin jew glibenclamide.
There is no experience in pregnant women, therefore the safety of Trazec in pregnant women cannot be assessed.
M’ hemm l- ebda esperjenza f’ nisa waqt it- tqala, għalhekk is- sigurta ’ ta ’ Trazec waqt it- tqala ma tistax tiġi stmata.
Trazec, like other oral antidiabetic agents, is not recommended for use in pregnancy.
Trazec, bħal aġenti ipogliċemiċi oħra li jittieħdu mill- ħalq, mhuwiex rakkomandat għall - użu waqt it- tqala.
Other events Other adverse events observed in clinical studies were of a similar incidence in Trazec-treated and placebo-treated patients.
Każijiet oħra Każijiet avversi oħrajn osservati fi studji kliniċi kienu ta ’ inċidenza simili f’ pazjenti ikkurati/ ittratati bi Trazec u f’ pazjenti kkurati bil- plaċebo.
In a clinical study in patients, Trazec was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated.
Fi studju kliniku, Trazec ingħata lill- pazjenti b’ dożi li kienu miżjuda sa 720 mg kuljum għal 7 ijiem u kienu tollerati sew.
There is no experience of an overdose of Trazec in clinical trials.
L- ebda każ ta ’ doża eċċessiva ta ’ Trazec ma ġie rrapurtat fi studji kliniċi.
5 when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c.
Nateglinide, meta jittieħed qabel ikla, ireġġa ’ lura l- ħila ta ’ sekrezzjoni ta’ insulina minn kmieni jew mill- ewwel fażi, li tkun intilfet f’ pazjenti b’ dijabete tip 2, li tirriżulta fit- tnaqqis ta ’ glucose ta ’ wara l - ikel u tnaqqis ta ’ HbA1c.
Absorption and bioavailability Nateglinide is rapidly absorbed following oral administration of Trazec tablets prior to a meal, with mean peak drug concentration generally occurring in less than 1 hour.
Assorbiment u biodisponibilità Nateglinide jiġi assorbit malajr wara li jingħataw pilloli Trazec mill- ħalq qabel ikla, bil- medja ta ’ l - ogħla konċentrazzjoni tal- mediċina ġeneralment isseħħ f’ inqas minn siegħa.
In type 2 diabetic patients given Trazec over the dose range 60 to 240 mg before three meals per day for one week, nateglinide showed linear pharmacokinetics for both AUC and Cmax, and tmax was independent of dose.
F’ pazjenti dijabetiċi tip 2 mogħtija Trazec fuq firxa ta ’ dożi minn 60 sa 240 mg qabel tlett ikliet kuljum għall ġimgħa, nateglinide wera farmakokinetiċi linjari għal AUC u Cmax, u tmax li kien independenti mid- doża.
The extent of serum protein binding is independent of drug concentration over the test range of 0.1– 10 μ g Trazec/ ml.
Kemm jeħel mal- proteini tas- serum jiddependi mill- konċentrazzjoni tal- mediċina fil -
Plasma concentrations decline rapidly and the elimination half-life of nateglinide typically averaged 1.5 hours in all studies of Trazec in volunteers and type 2 diabetic patients.
Il - konċentrazzjonijiet fil- plażma malajr jonqsu u l- half- lifee tatt- tneħħija ta ’ nateglinide tipikament kellha medja ta ’ 1. 5 sigħat fl- istudji kollha ta ’ Trazec f’ voluntiera u f’ pazjenti dijabetiċi tip 2.
It is recommended that Trazec be administered prior to meals.
Huwa rakkomandat li Trazec jingħata qabel l- ikliet.
5.3 Preclinical safety data
7 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- medicina
Lactose monohydrate Cellulose, microcrystalline Povidone Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc Macrogol Silica, colloidal anhydrous
Lactose monohydrate Cellulose, microcrystalline Povidone Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc Macrogol Silica, colloidal anhydrous
Not applicable
Ma jgħoddx f’ dan il- kaz.
Packs contain 12, 60, 84, 120 and 360 tablets.
Pakketti li fihom 12, 60, 84, 120 u 360 pillola.
TRAZEC 120 mg film-coated tablets
TRAZEC 120 mg pilloli miksijin b’ rita
283 mg per tablet
283 mg għal kull pillola.
120 mg yellow, ovaloid tablets with “ NVR” marked on one side and “ TSL” on the other.
Pilloli b’ 120 mg sofor, b’ għamla fl- ovali b ’ “ NVR ” immarkat fuq naħa u “ TSL ” fuq l- oħra.
TRAZEC 180 mg film-coated tablets
TRAZEC 180 mg pilloli miksijin b’ rita
214 mg per tablet
214 mg għal kull pillola.
180 mg red, ovaloid tablets with “ NVR” marked on one side and “ TSX” on the other.
Pilloli b’ 180 mg ħomor, b’ għamla fl- ovali b ’ “ NVR ” immarkat fuq naħa u “ TSX ” fuq l- oħra.
Trazec 60 mg film-coated tablets Nateglinide
Trazec 60 mg pilloli miksijin b’ rita Nateglinide
12 film-coated tablets 60 film-coated tablets 84 film-coated tablets 120 film-coated tablets 360 film-coated tablets
12- il pillola miksija b’ rita 60 pillola miksija b’ rita 84 pillola miksija b’ rita 120 pillola miksija b’ rita 360 pillola miksija b’ rita
Trazec 60 mg tablets Nateglinide
Trazec 60 mg pilloli Nateglinide
Trazec 120 mg film-coated tablets Nateglinide
Trazec 120 mg pilloli miksijin b’ rita Nateglinide
12 film-coated tablets 60 film-coated tablets 84 film-coated tablets 120 film-coated tablets 360 film-coated tablets
12 pillola miksija b’ rita 60 pillola miksija b’ rita 84 pillola miksija b’ rita 120 pillola miksija b’ rita 360 pillola miksija b’ rita
Trazec 120 mg tablets Nateglinide
Trazec 120 mg pilloli Nateglinide
Trazec 180 mg film-coated tablets Nateglinide
Trazec 180 mg pilloli miksijin b’ rita Nateglinide
Trazec 180 mg tablets Nateglinide
Trazec 180 mg pilloli Nateglinide
Trazec 60 mgfilm-coated tablets Trazec 120 mg film-coated tablets Trazec 180 mg film-coated tablets Nateglinide
Trazec 60 mg pilloli miksija b’ rita Trazec 120 mg pilloli miksija b’ rita Trazec 180 mg pilloli miksija b’ rita Nateglimide