qanastek/EMEA-V3 huggingface dataset:
Tonography and fluorophotometry studies in man suggest that its predominant action is related to reduced aqueous humour formation and a slight increase in outflow facility.
Studji tonografiċi u florofotometriċi fil- bniedem jissuġġerixxu li l- azzjoni predominanti tiegħu hija relata ma ’ tnaqqis ta ’ formazzjoni tal- aqueous humour u żjieda ħafifa fil- faċilità ta ’ tneħħija.
Secondary pharmacology Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of topical ocular administration (1.4 micrograms, once-daily).
7 Farmakoloġija sekondarja Wara 7 ijiem ta ’ għoti topiku fl- għajn (1. 4 mikrogrammi, darba kuljum), Travaprost żied b’ mod sinifikanti ċ- ċirkolazzjoni tad- demm lejn ir- ras tan- nerv ottiku fil- fniek.
Pharmacodynamic effects Clinical effects In a twelve-month, controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of DuoTrav dosed once-daily in the morning was 8 to 10 mmHg.
Effetti Farmakodinamiċi Effetti Kliniċi Fi studju kliniku kkontrollat ta ’ tnax- il xahar, f’ pazjenti bi glawkoma open angle jew pressjoni għolja ta ’ l- għajnejn u linja bażi medja ta ’ IOP ta ’ 25 sa 27 mmHg, il- medja tal- effett ta ’ tnaqqis fl- IOP ta ’ DuoTrav mogħti darba kuljum filgħodu kien ta ’ 8 sa 10 mmHg.
The non-inferiority of DuoTrav as compared to latanoprost 50 micrograms/ ml + timolol 5 mg/ ml in the mean IOP reduction was demonstrated across all time-points at all visits.
In- nuqqas ta ’ nferjorità ta ’ DuoTrav kif mqabbel ma ’ latanoprost 50 mikrogramma/ ml + timolol 5 mg/ ml fil- medja ta ’ tnaqqis tal- IOP intwera tul il- punti ta ’ ħin kollha fil- visti kollha.
7 In a three-month, controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 27 to 30 mmHg, the mean IOP-lowering effect of DuoTrav dosed once-daily in the morning was 9 to 12 mmHg, and was up to 2 mmHg greater than that of travoprost 40 micrograms/ ml dosed once-daily in the evening and 2 to 3 mmHg greater than that of timolol 5 mg/ ml dosed twice daily.
Fi studju kliniku kkontrollat ta ’ tliet xhur, f’ pazjenti bi glawkoma open angle jew pressjoni għolja ta ’ l- għajnejn u linja bażi medja ta ’ IOP ta ’ 27 sa 30 mmHg, l- effett medju ta ’ tnaqqis fl- IOP ta ’ DuoTrav mogħti darba kuljum filgħodu kien ta ’ 9 sa 12 mmHg, u kien sa 2 mmHg aktar minn dak ta ’ travoprost 40 mikrogramma/ ml mogħti darba kuljum filgħaxija u 2 sa 3 mmHg aktar minn dak ta ’ timolol 5 mg/ ml mogħti darbtejn kuljum.
A statistically superior reduction in morning mean IOP (8AM-24 hours after the last dose of DuoTrav) was observed compared to travoprost at all visits throughout the study.
Fil- visti kollha tul l- istudju kien osservat tnaqqis statistikament superjuri fl- IOP medja ta ’ filgħodu (8AM- 24 siegħa wara l- aħħar doża ta ’ DuoTrav) meta mqabbel ma ’ travoprost.
In two three-month, controlled clinical studies in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 23 to 26 mmHg, the mean IOP-lowering effect of DuoTrav dosed once-daily in the morning was 7 to 9 mmHg.
F’ żewġ studji kliniċi kkontrollati ta ’ tliet xhur f’ pazjenti bi glawkoma open angle jew pressjoni għolja ta ’ l- għajnejn u linja bażi medja ta ’ IOP ta ’ 23 sa 26 mmHg, l- effett medju ta ’ tnaqqis fl- IOP ta ’ DuoTrav mogħti darba kuljum filgħodu kien ta ’ 7 sa 9 mmHg.
Mean IOP reductions were non-inferior, although numerically lower, to those achieved by concomitant therapy with travoprost 40 micrograms/ ml dosed once-daily in the evening and timolol 5 mg/ ml dosed once-daily in the morning.
Il- medja ta ’ tnaqqis fl- IOP ma kienux inferjuri, għalkemm numerikament inqas, minn dawk li nkisbu b’ terapija fl- istess waqt b’ travoprost 40 mikrogramma/ ml mogħti darba kuljum filgħaxija u timolol 5 mg/ ml mogħti darba kuljum filgħodu.
Inclusion criteria were common across the studies, with the exception of the IOP entry criteria and response to previous IOP therapy.
Kriterji ta ’ l- inklużjoni kienu komuni tul l- istudji, bl- eċċezzjoni tal- kriterju tal- IOP tad- dħul u tar - rispons għal terapija għall- IOP minn qabel.
The clinical development of DuoTrav included both patients naive and on therapy.
L- iżvilupp kliniku ta ’ DuoTrav kien jinkludi kemm pazjenti ġodda għat- terapija kif ukoll pazjenti fuq it- terapija.
Insufficient responsiveness to monotherapy was not an inclusion criteria.
Rispons insuffiċjenti għall- monoterapija ma kienx kriterju ta ’ inklużjoni.
Existing data suggest that evening dosing might have some advantages in the mean IOP reduction.
Tagħrif eżistenti jissuġġerixxi li l- għoti filgħaxija jista ’ jkollu xi vantaġġi fil- medja tat- tnaqqis tal- IOP.
Consideration should be given to patient convenience and their likely compliance when recommending morning vs. evening dosing.
Għandha tingħata kunsiderazzjoni għall- konvenjenza tal- pazjent u l- probabbilità li jsegwi t- teħid meta jiġi rrakkomandat għoti filgħodu vs. għoti filgħaxija.
Absorption Travoprost and timolol are absorbed through the cornea.
Assorbiment Travoprost u timolol jiġu asorbiti min ġewwa l- korneja.
Travoprost is a prodrug that undergoes rapid ester hydrolysis in the cornea to the active free acid.
Travoprost huwa prodrug li jgħaddi minn idrolisi rapida ta ’ ester fil- korneja għall- aċidu ħieles attiv.
Following once-daily administration of DuoTrav in healthy subjects (N=15) for 3 days, travoprost free acid was not quantifiable in plasma samples from the majority of subjects (80%) and was not detectable in any samples one hour after dosing.
Wara l- għoti ta ’ DuoTrav darba kuljum f’ individwi b’ saħħithom (N=15) għall- tlett ijiem, l- aċidu ħieles ta ’ travoprost ma setax jiġi ikwantifikat fil- kampjuni tal- plażma fil- maġġoranza ta ’ l- individwi (80%) u ma kien osservat fl- ebda kampjun siegħa wara li ttieħdet id- doża.
When measurable (≥ 0.01 ng/ ml, the assay limit of quantitation), concentrations ranged from 0.011 to 0.020 ng/ ml.
Meta setgħa jiġi mkejjel (≥ 0. 01 ng/ ml, il- limitu tal- assay tal - kwantifikazzjoni), il- konċentrazzjonijiet varjaw minn 0. 011 sa 0. 020 ng/ ml.
The mean timolol steady-state Cmax was 0.692 ng/ ml and Tmax was approximately 1 hour after once-daily administration of DuoTrav.
C max fi stat stabbli medja ta ’ timolol kienet 0. 692 ng/ ml u T max kien madwar siegħa wara l- għoti ta ’ darba kuljum ta ’ DuoTrav.
Travoprost free acid can be measured in the aqueous humour during the first few hours in animals and in human plasma only during the first hour after ocular administration of DuoTrav.
Distribuzzjoni Wara l- għoti ta ’ DuoTrav fl- għajnejn, l- aċidu ħieles ta ’ travoprost jista jiġi mkejjel fl- aqueous humour fil- bhejjem matul l- ewwel ftit sigħat u fil- plażma tal- bnedmin matul l- ewwel siegħa biss.
Timolol can be measured in human aqueous humour after ocular administration of timolol and in plasma for up to 12 hours after ocular administration of DuoTrav.
Timolol jista jiġi mkejjel fl- aqueous humour tal- bnedmin wara l- għoti ta ’ timolol fl- għajnejn u fil- plażma sa tnax- il siegħa wara l- għoti ta ’ DuoTrav fl- għajnejn.
Metabolism Metabolism is the major route of elimination of both travoprost and the active free acid.
8 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 li huma kkaratterizzati minn tnaqqis tad- double bond 13- 14, ossidazzjoni tal- qsim 15- hydroxy u β- oxidative tal- katina tat- tarf tan- naħa ta ’ fuq.
Timolol is metabolised by two pathways.
Timolol huwa metaboliżżat minn żewġ rotot.
One route yields an ethanolamine side chain on the thiadiazole ring and the other giving an ethanolic side chain on the morpholine nitrogen and a second similar side chain with a carbonyl group adjacent to the nitrogen.
Rotta minnħom tipproduċi katina tat- tarf ta ’ ethanolamine fuq iċ- ċirku thiadiazole u l- oħra tagħti katina tat- tarf etanolika fuq morpholine nitrogen u katina tat- tarf oħra simili bi grupp carbonyl viċin nitrogen.
The plasma t1/ 2 of timolol is 4 hours after ocular administration of DuoTrav.
It- t1/ 2 fil- plażma ta ’ timolol huwa 4 sigħat wara l- għoti fl- għajn ta ’ DuoTrav.
Excretion Travoprost free acid and its metabolites are mainly excreted by the kidneys.
Eliminazzjoni L- aċidu ħieles ta ’ travoprost u l- metaboliti tiegħu jiġu eliminati fil- biċċa l- kbira mill- kliewi.
Less than 2% of an ocular dose of travoprost was recovered in urine as free acid.
Inqas minn 2% ta ’ doża għall- għajnejn kienet irkuprata fl- awrina bħala aċidu ħieles.
Timolol and its metabolites are primarily excreted by the kidneys.
Timolol u l- metaboliti tiegħu jiġu eliminati fil- biċċa l- kbira mill- kliewi.
Approximately 20% of a timolol dose is excreted in the urine unchanged and the remainder excreted in urine as metabolites.
Madwar 20% tad- doża ta ’ timolol tiġi eliminata mhux mibdula fl- awrina u l- kumplament tiġi mneħħija fl- awrina bħala metaboliti.
8 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
In monkeys, administration of DuoTrav twice– daily was shown to induce increased palpebral fissure and to increase iris pigmentation similar to that observed with ocular administration of prostanoids.
Fix- xadini, l- għoti ta ’ DuoTrav darbtejn kuljum intwera li jikkawża żjieda fil- fetħa tal- palpebra u żjieda fil- pigmentazzjoni tal- ħabba tal- għajn, simili għal dak osservat bl- għoti ta ’ prostanoids fl - għajnejn.
Travoprost 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.
Travoprost L- għoti ta ’ travoprost 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 with travoprost have been undertaken in rat, mice and rabbit by systemic route.
Saru studji dwar it- tossiċità fis- sistema riproduttiva, fil- firien, ġrieden u fniek bi travoprost mogħti b’ mod 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- utru u kien hemm mewt bikri tal- embriju, telf tal- embriju wara li ġie impjantat u tossiċità lill- fetu.
In pregnant rat, systemic administration of travoprost at doses more than 200 times the clinical dose during the period of organogenesis resulted in an increased incidence of malformations.
F’ firien tqal, l - għoti sistemiku ta ’ travoprost f’ dożi aktar minn 200 darba d- doża klinika, waqt il- perijodu tal - organoġenesi rriżulta f’ żjieda fl- inċidenza ta ’ malformazzjonijiet.
Low levels of radioactivity were measured in amniotic fluid and foetal tissues of pregnant rats administered 3H-travoprost.
F’ firien tqal li ngħataw 3H - travaprost, kienu mkejla livelli baxxi ta ’ radjuattività fil- fluwidu amnijotiku u fit- tessuti tal- fetu.
Reproduction and development studies have demonstrated a potent effect on foetal loss with a high rate observed in rats and mice (180 pg/ ml and 30 pg/ ml plasma, respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/ ml).
Studji dwar ir- riproduzzjoni u l- iżvilupp urew effett qawwi fuq it- telf tal- fetu, b’ rata għolja osservata fil - firien u ġrieden (180 pg/ ml u 30 pg/ ml fil- plażma, rispettivament) f’ espożizzjonijiet ta ’ 1. 2 sa 6 darbiet l- espożizzjoni klinika (sa 25 pg/ ml).
Timolol Non-clinical data revealed no special hazard for humans with timolol based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenic potential.
Timolol Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni u riskju ta ’ kanċer, ma turi l- ebda periklu speċjali għall- bnedmin.
Reproduction toxicity studies with timolol showed delayed foetal ossification in rats with no adverse effects on postnatal development (7000 times the clinical dose) and increased foetal resorptions in rabbits (14000 times the clinical dose).
Studji dwar it- tossiċità fuq is- sistema riproduttiva b’ timolol urew ossifikazzjoni ttardjata tal- fetu fil- firien bl- ebda effett avvers fuq l- iżvilupp ta ’ wara t- twelid (7000 darba id- doża klinika) u żjieda fl- assorbiment mill- ġdid tal- fetu fil- fniek (14000 darba id- doża klinika).
Benzalkonium chloride Mannitol Trometamol Polyoxyethylene hydrogenated castor oil 40 (HCO-40) Boric acid Disodium edetate Hydrochloric acid (for pH adjustment) Purified water
Benzalkonium Chloride Mannitol Trometamol Polyoxyethylene hydrogenated castor oil 40 (HCO- 40) Boric acid Disodium edetate Hydrochloric acid (għall- aġġustament tal- pH) Ilma ppurifikat
6.2 Incompatibilities
9 6. 2 Inkompatibilitajiet
Discard 4 weeks after first opening.
Armi 4 ġimgħat wara li jinfetaħ l- ewwel darba.
9 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
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, 3 or 6 bottles.
Kaxxa li fiha 1, 3 jew 6 flixken.
Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom.
Boundary Way Hemel Hempstead Herts HP2 7UD Ir- Renju Unit
Date of first Authorisation:
Data ta ’ l- ewwl awtorizzazzjoni:
24/ 04/ 06 Date of last Renewal:
24/ 04/ 06 Data tal- aħħar tiġdid:
Alcon Couvreur N. V., Rijksweg 14, B-2870, Puurs, Belgium
Alcon- Couvreur N. V., Rijksweg 14, B- 2870 Puurs, Il- Belġju.
Alcon Cusí, S. A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
Alcon Cusí, S. A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spanja
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza hija mplimentata u qed tiffunzjona qabel il- prodott jitqiegħed fis- suq.
An updated Risk management should be provided as per the CHMP guideline on Risk Management System for medicinal products for human use.
Skond il- Linji Gwida tas- CHMP dwar is- Sistema għall- Immanniġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, għandu jiġi pprovdut Pjan għall- Immanniġjar ta ’ Riskji aġġornat.
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR SINGLE BOTTLE 2.5 ml + CARTON FOR 3 x 2.5 ml BOTTLES + CARTON FOR 6 x 2.5 ml BOTTLES
KARTUNA GĦALLFLIXKUN WIEĦED 2. 5 ml + KARTUNA GĦAL 3 x 2. 5 ml FLIXKEN + KARTUNA GĦAL 6 x 2. 5 ml FLIXKEN
DuoTrav 40 micrograms/ ml + 5 mg/ ml eye drops, solution Travoprost/ Timolol
Travoprost/ Timolol
1 ml of solution contains 40 micrograms travoprost and 5 mg timolol (as timolol maleate)
1 ml ta ’ soluzzjoni fih 40 mikrogramma travoprost u 5 mg timolol (bħala timolol maleate)
Benzalkonium chloride, mannitol, trometamol, polyoxyethylene hydrogenated castor oil 40 (HCO-40), boric acid, disodium edetate, hydrochloric acid (to adjust pH), purified water.
Benzalkonium chloride, mannitol, trometamol, polyoxyethylene hydrogenated castor oil 40 (HCO- 40), boric acid, disodium edetate, hydrochloric acid (biex jikontrolaw il- pH), ilma ppurifikat.
See leaflet for further information.
Ara il- fuljett għal aktar tagħrif
Eye drops, solution; 1 x 2.5 ml 3 x 2.5 ml 6 x 2.5 ml
1 x 2. 5 ml 3 x 2. 5 ml 6 x 2. 5 ml
Ocular use.
Għal użu fl- għajnejn.
Boundary Way Hemel Hempstead Herts, HP2 7UD United Kingdom.
Boundary Way Hemel Hempstead Herts, HP2 7UD Ir- Renju Unit
MARKETING AUTHORISATION NUMBERS
NUMRU( I) TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
16 INFORMATION IN BRAILLE
INFORMAZZJONI BIL- BRAILLE
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
16 TAGHRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻAGĦAR EWLENIN
DuoTrav 40 micrograms/ ml + 5 mg/ ml eye drops travoprost/ timolol Ocular use
DuoTrav 40 mikrogramma/ ml + 5 mg/ ml qtar għall- għajnejn
For further information pull up label at arrow
Għal aktar informazzjoni qaxxar it- tikketta fejn hemm immarkat
2.5 ml
2. 5 ml.
6 OTHER
OĦRAJN
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 TAGHRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻAGĦAR EWLENIN
OVERWRAP
IL- PAKETT TA ’ PROTEZZJONI
DuoTrav 40 micrograms/ ml + 5 mg/ ml eye drops
DuoTrav 40 mikrogramma/ ml + 5 mg/ ml qtar għall- għajnejn
Discard 4 weeks after first opening.
Armi 4 ġimgħat wara li jinfetaħ l- ewwel darba
INFORMATION FOR THE USER
INFORMAZZJONI GHAL MIN QED JAGĦMEL UŻU MINNU
DuoTrav 40 micrograms/ ml + 5 mg/ ml eye drops, solution travoprost/ timolol
DuoTrav 40 mikrogramma/ ml + 5 mg/ ml qtar għall- għajnejn, soluzzjoni travoprost/ timolol.
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.
In this leaflet
F’ dan il- fuljett:
What DuoTrav is and what it is used for 2.
X’ inhu DuoTrav u għalxiex jintuża 2.
Before you use DuoTrav 3.
Qabel ma tuża DuoTrav 3.
How to use DuoTrav 4.
Kif għandek tuża DuoTrav 4.
How to Store DuoTrav 6.
Kif taħżen DuoTrav 6.
WHAT DuoTrav IS AND WHAT IT IS USED FOR
X’ INHU DuoTrav U GĦALXIEX JINTUŻA
DuoTrav eye drops are used to treat high pressure in the eye.
DuoTrav qtar għall- għajnejn jintuża għal kura ta ’ pressjoni għolja fl- għajn.
This pressure can lead to an illness called glaucoma.
Din il- pressjoni għolja tista ’ twassal għall- marda li tissejjaħ glawkoma.
High pressure in the eye.
Pressjoni għolja fl- għajn.
Your eyeballs contain a clear, watery liquid which feeds the inside of the eye.
Il- boċoċ t’ għajnejk fihom likwidu ċar, qisu ilma, li jitma ’ il- parti ta ’ ġewwa ta ’ l- 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 dejjem qed jiġi magħmul.
If the eye fills up faster than it empties, the pressure inside the eye builds up.
Jekk l- għajn timtela aktar malajr milli titbattal, il- pressjoni ġewwa l- għajn tibda togħla.
If it gets too high, it can damage your sight.
Jekk din tkun għolja wisq, tista ’ tagħmel ħsara lill- vista tiegħek.
DuoTrav is a combination of treatments for glaucoma.
DuoTrav huwa taħlita ta ’ aktar minn kura waħda għall- glawkoma.
Travoprost is a prostaglandin analogue which works by increasing the outflow of liquid, which lowers the pressure in the eye.
Travoprost huwa analogu ta ’ prostaglandin li jaħdem billi jżid il- ħruġ tal- likwidu, u b’ hekk ibaxxi l- pressjoni fl- għajn.
Timolol is a beta blocker which works by reducing the production of fluid within the eye.
Timolol huwa mblokkatur tar- riċetturi beta li jaħdem billi jnaqqas il- produzzjoni tal- likwidu ġewwa l- għajn.
The two ingredients work together to reduce pressure within the eye.
Iż- żewġ ingredjenti jaħdmu flimkien biex ibaxxu l- pressjoni ġewwa l- għajn.
BEFORE YOU USE DuoTrav
QABEL MA ’ TUŻA DuoTrav
Do not use DuoTrav • if you are allergic to travoprost, prostaglandins, timolol, beta-blockers or any of the other ingredients. • if you have respiratory problems such as asthma, bronchitis or other types of breathing problems • if you have severe hay fever • if you have a slow heart beat, heart failure or disorders of heart rhythm • If the surface of your eye is cloudy
Tużax DuoTrav • jekk inti allerġiku għal travoprost, prostaglandins, timolol, imblokkaturi tar- riċetturi beta jew sustanzi oħra ta ’ DuoTrav • jekk għandek problemi respiratorji bħal ażżma, bronkite jew tipi oħra ta ’ problemi relatati man- nifs. • jekk għandek hay fever severa • jekk għandek ir- rata ta ’ taħbit tal- qalb baxxa, insuffiċjenza tal- qalb jew disturbi fir- ritmu tal- qalb • jekk il- wiċċ ta ’ għajnejk huwa mċajpar
Ask your doctor for advice if any of these apply to you.
Jekk xi wieħed minn dawn japlika għalik, staqsi lit- tabib tiegħek għall- parir.
20 Take special care with DuoTrav
20 Oqgħod attent ħafna b’ DuoTrav
• DuoTrav may cause breathlessness or wheezing.
• DuoTrav jista ’ jikawża qtugħ ta ’ nifs jew tħarħir.
• If you get any severe allergic reaction while you are using DuoTrav, whatever the cause, adrenaline treatment may not be as effective.
Jekk qed tinkwieta minħabba bidliet fil - mogħod ta ’ kif tieħu n- nifs meta qed tuża DuoTrav, għid lit- tabib tiegħek malajr kemm jista ’ jkun. • Jekk ikollok xi reazzjoni allerġika severa waqt li qed tuża DuoTrav, tkun xi tkun il- kawża, kura bl- adrenalina tista ’ ma ’ tkunx daqshekk effettiva.
So when receiving any other treatment please tell the health professional that you are using DuoTrav.
Għalhekk, meta tirċievi xi kura oħra, jekk jogħġbok, għid lill- professjonist fil- qasam tas- saħħa li qed tuża DuoTrav.
• If you have angina, circulation problems or low blood pressure.
• Jekk għandek anġina, problemi fiċ- ċirkulazzjoni jew pressjoni tad- demm baxxa.
DuoTrav may make any of these worse.
DuoTrav jista ’ jaggrava kull wieħed minn dawn il- kundizzjonijiet.
If you are concerned about any changes in these symptoms, tell your doctor as soon as possible.
Jekk qed tinkwita dwar xi bidliet f’ dawn is- sintomi, għid lit- tabib tiegħek malajr kemm jista ’ jkun.
• If you have diabetes.
• Jekk għandek dijabete.
DuoTrav can mask the symptoms of low blood sugar (hypoglycaemia) such as shakiness and dizziness, so you need to use it with care.
DuoTrav jista ’ jaħbi is- sintomi ta ’ zokkor fid- demm baxx (ipogliċemija) bħal tregħid u sturdament, għalhekk għandek tużah b’ attenzjoni.
• If you are under 18.
• Jekk int taħt 18- il sena.
DuoTrav is not to be used by people under 18 years of age.
DuoTrav m’ għandux jintuża minn persuni taħt 18- il sena.
• DuoTrav may change the colour of your iris (the coloured part of your eye).
• DuoTrav jista ’ jbiddel il- kulur tal- ħabba tal- għajnejk (il- parti kkulurita ta ’ għajnejk).
This change may be permanent.
Din il - bidla tista tkun permanenti.
• DuoTrav may increase the length, thickness, colour and/ or number of your eyelashes and may cause unusual hair growth on your eyelids.
• DuoTrav 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.
• Travoprost may be absorbed through the skin and therefore should not be used by women who are pregnant or are attempting to become pregnant.
• Travoprost jista ’ jiġi assorbit mill- ġilda u għalhekk m’ għandux jintuża minn nisa tqal jew li qed jippruvaw joħorġu tqal.
If any of the product comes into contact with the skin then it should be washed off straight away.
Jekk il- prodott jiġi f’ kuntatt mal- ġilda għandu jitneħħa minnufih permezz ta ’ ħasil.
DuoTrav can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
DuoTrav jista ’ jaffetwa jew jiġi affetwat minn mediċini oħra li qed tuża, nkluż qtar għall- għajnejn oħra għall- kura tal- glawkoma.
Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes.
Għid lit- tabib tiegħek jekk qed tuża jew bi ħsiebek tuża mediċini li jbaxxu l- pressjoni tad- demm, mediċini għall- qalb jew mediċini għall- kura tad- dijabete.
Do not use DuoTrav if you are pregnant.
Tużax DuoTrav jekk inti tqila.
If you could get pregnant you must use adequate contraception whilst you use the medicine.
Jekk tista ’ toħroġ tqila għandek tuża kontraċezzjoni adegwata waqt li qed tuża l- mediċina.
If you are breast-feeding, DuoTrav may get into your milk.
Jekk qed tredda ’, DuoTrav 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 DuoTrav.
Għandek mnejn issib li l- vista tiegħek tkun imċajpra għal xi ħin wara li tuża DuoTrav.
Do not drive or use machines until this has worn off.
M’ għandekx tagħmel użu minn għodda jew tħaddem magni qabel dan l- effett jitlaq.
Important information about some of the ingredients • If you wear soft contact lenses.
Tużax il- qtar waqt li l- lentijiet tal- kuntatt huma f’ għajnejk.
Do not use the drops with your lenses in your eyes Wait 15 minutes after using the drops before putting your lenses back into your eyes.
Stenna 15- il minuta wara li tuża l- qtar qabel ma terġa ’ tpoġġi l- lentijiet tal- kuntatt f’ għajnejk.
A preservative in DuoTrav (benzalkonium chloride) can affect soft lenses.
Preservattiv ġo DuoTrav (benzalkonium chloride) jista ’ jagħmel ħsara lill- lentijiet tal- kuntatt rotob.
21 • DuoTrav contains hydrogenated castor oil, which may cause skin reactions.
21 • DuoTrav fih hydrogenated castor oil, li jista ’ jikkawża reazzjonijiet mal- ġilda.
HOW TO USE DuoTrav Always use DuoTrav exactly as your doctor has told you. You should 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 dubju.
The usual dose
Id- doża tas- soltu
1 drop in the eye or eyes, once a day-in the morning or in the evening.
Qatra waħda ġo l- għajn jew għajnejn, darba kuljum- filgħodu jew filgħaxija.
Use at the same time each day.
Uża fl- istess ħin kuljum.
Only use DuoTrav in both eyes if your doctor told you to.
Uża DuoTrav f’ għajnejk it- tnejn biss, jekk qallek it- tabib tiegħek.
Use it for as long as your doctor told you to.
Uża għat- tul ta ’ żmien li qallek it - tabib tiegħek.
Only use DuoTrav for dropping in your eyes.
Uża DuoTrav biss biex tqattar f’ għajnejk.
• 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 DuoTrav 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, qatta ’ l- 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 ’ DuoTrav u mera • Aħsel idejk • Neħħi t- tapp 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.
The drop will go in here (picture 2) • Bring the bottle tip close to the eye.
Il- qatra se tmur hawn (stampa 2) • Ġib it- tarf tal- flixkun viċin tal- għajn.
Use the mirror if it helps • Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Jekk jgħin uża l- mera • Tmisx għajnejk jew il- kappell ta ’ l- għajn, il- postijiet tal- madwar jew superfiċji oħra bil - qattara tal- flixkun.
It could infect the drops • Gently squeeze the bottle to release one drop of DuoTrav at a time (picture 3) • After using DuoTrav, press a finger into the corner of your eye, by the nose (picture 4).
Dan jista ’ jinfetta l- qtar • Agħfas il- flixkun bil- mod biex tinżel qatra waħda ta ’ DuoTrav kull darba (stampa 3). • Wara li tuża DuoTrav, agħfas b’ subgħajk il- kantuniera ta ’ għajnejk, in- naħa ta ’ l- imnieħer (stampa 4).
This helps to stop DuoTrav getting into the rest of the body • If you use 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 DuoTrav milli jidħol fil- bqija tal- ġisem • Jekk tuża l- qtar fiż- żewġt għajnejn, irrepeti l- proċedura għall- għajnek l- oħra • Agħlaq l- għatu tal- flixkun tajjeb immedjatament wara l- użu • Uża biss flixkun wieħed qabel ma tiftaħ ieħor.
Do not open the pouch until you need to use the bottle.
Tiftaħx il- pakkett ta ’ protezzjoni qabel ikollok bżonn tuża l- flixkun.
Turn the page for more advice
Aqleb il- paġna għall- aktar tagħrif
How much to use < see side 1
Kemm għandek tuża < ara naħa 1
If a drop misses your eye, try again.
Jekk qatra ma ’ tidħolx f’ għajnejk, erġa ’ pprova.
If you use more DuoTrav than you should, rinse it all out with warm water.
Jekk tuża DuoTrav aktar milli suppost, laħlaħ b’ ilma sħun.
Do not put in any more drops until it is time for your next regular dose.
Tużax aktar qtar sakemm ikun il- ħin għad- doża tas- soltu li jmiss.
If you forget to use DuoTrav, continue with the next dose as planned.
22 Jekk tinsa tuża DuoTrav, kompli bid- doża li jmiss kif ippjanat.
Do not use a double dose to make up.
M’ għandekx tuża doża doppja biex tpatti għad- doża li tkun insejt tieħu.
The dose should not exceed one drop in the affected eye(s) daily.
Id- doża m’ għandhiex tkun aktar minn qatra waħda kuljum fl - għajn( ejn) affetwata( i).
22 If you stop using DuoTrav without speaking to your doctor the pressure in your eye will not be controlled which could lead to loss of sight.
Jekk tieqaf tuża DuoTrav 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 DuoTrav and the other drops.
Jekk qed tuża qtar ta ’ l- għajnejn oħra, ħalli mill- anqas 5 minuti bejn l- użu ta ’ DuoTrav u tal- qtar ieħor.
If you have any other questions about your medicine, ask a doctor or pharmacist.
Jekk għandek aktar mistoqsijiet oħra dwar dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill - ispiżjar tiegħek.
Like all medicines DuoTrav can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, DuoTrav jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
You can usually carry on taking the drops, unless the effects are serious.
Ġeneralment tista ’ tkompli tuża l- qtar, sakemm l- effetti ma jkunux ta ’ natura serja.
If you're worried, talk to a doctor or pharmacist.
Jekk qed tinkwieta, kellem tabib jew spiżjar.
Do not stop using DuoTrav without speaking to your doctor.
Twaqqafx l- uża ta ’ DuoTrav mingħajr ma tkellem lit- tabib tiegħek.
Very common side effects (Occur in more than one user in 10) Effects in the eye: eye irritation, redness of the eye
Effetti sekondarji komuni ħafna (Iseħħu f’ aktar minn persuna waħda li qed tużah minn kull 10) Effetti fl- għajn: irritazjoni fl- għajn, ħmura fl- għajn.
Common side effects (occur in 1 to 10 users in 100).
Effetti sekondarji komuni (iseħħu f’ 1 sa 10 persuni li qed jużawh minn kull 100).
Effects in the eye: inflammation inside the eye, eye pain and swelling, sensitivity to light, conjunctival bleeding, blurred vision, dry eye, itchy eye, eye allergy, increased tear production, eyelid irritation, itching, redness, pain and swelling; tired eyes, increased growth or number of eye lashes
Effetti fl- għajn: infjammazjoni ġewwa l- għajn, uġigħ u nefħa fl- għajn, sensittività għad- dawl, fsada mill- konġuntiva, vista mċajpra, għajn tinħass xotta, allerġija fl- għajn, żjieda fid- dmugħ, irritazzjoni fil - kappell tal- għajn, ħakk, ħmura, uġigħ u nefħa; għeja fl- għajn, żjieda fit- tkabbir u n- numru ta ’ xagħar tal- għajnejn.
General side effects: nervousness, dizziness, headache, irregular or decreased heart rate, increased or decreased blood pressure, shortness of breath, hives, skin darkening around eyes, pain in hands and feet
Effetti sekondarji ġenerali: nervi, sturdament, uġigħ ta ’ ras, rata ta ’ taħbit tal- qalb irregolari jew imnaqqsa, żjieda jew tnaqqis fil- pressjoni tad- demm, qtugħ ta ’ nifs, ħorriqija, il- ġilda madwar l - għajnejn tiskura, uġigħ fl- idejn u s- saqajn.
Uncommon side effects (occur in 1 to 10 users in 1,000)
Effetti sekondarji mhux komuni (iseħħu f’ 1 sa 10 persuni li qed jużawh minn kull 1, 000).
Effects in the eye: corneal disorder, eye surface inflammation, swollen conjunctiva
Effetti fl- għajn: disturb fil- korneja, infjammazzjoni tas- superfiċje tal- għajn, nefħa tal- konġuntiva
General side effects: cough, throat irritation, drip at back of throat, abnormal liver blood tests, skin inflammation and itching, coloured urine, thirst
Effetti sekondarji ġenerali: sogħla, irritazzjoni fil- griżmejn, taqtir wata l- griżmejn, testijiet tad- demm tal- fwied mhux normali, infjammazzjoni tal- ġilda u ħakk, awrina kkulurita, għatx.
Additional side effects from post-marketing experience with DuoTrav for which the frequency is unknown include:
Effetti sekondarji oħra mill- esperjenza ta ’ wara t- tqegħid fis- suq b’ DuoTrav li għalihom il- frekwenza mhix magħrufa jinkludu:
Additional side effects that have been reported previously in people using eye drops containing travoprost or timolol and that have not been reported with DuoTrav include:
Effetti fl- għajn: infjammazzjoni tal- ħabba tal- għajn, il- kappell tal- għajn baxx Effetti sekondarji ġenerali: raxx, insuffiċjenza tal- qalb, uġigħ fis- sider, puplesija, ħass ħazin, depressjoni, ażżma, żjieda fir- rata tal- qalb, sensazzjoni ta ’ tnemnim jew tingiż, telf ta ’ xagħar Effetti sekondarji oħra li ġew irrapportati qabel f’ nies li kienu qed jużaw qtar għall- għajnejn li kien fihom travoprost jew timolol u li ma kienux irrapportati b’ DuoTrav jinkludu:
Effects in the eye: double vision, eyelid crusting, changes in the colour of the iris
23 Effetti fl- għajn: viżjoni dopja, qxur fuq il- kappell tal- għajn, bidla fil- kulur tal- ħabba tal- għajn.
General side effects: heart attack, decreased blood flow to the brain, low blood sugar, loss of strength and energy, diarrhoea, nausea, peeling skin, stuffy nose, chronic neuromuscular weakness, respiratory failure
Effetti sekondarji ġenerali: attakk tal- qalb, tnaqqis fl- ammont ta ’ demm li jmur għall- moħħ, zokkor fid- demm baxx, nuqqas ta ’ saħħa u enerġija, dijarea, tqalligħ, ġilda titqaxxar, imnieħer fgat, debbulizza newromuskolari kronika, insuffiċjenza respiratorja Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE DuoTrav
KIF TAĦŻEN DuoTrav
Do not use DuoTrav after the expiry date which is stated on the bottle and box after “ EXP”.
Tużax DuoTrav wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kaxxa wara “ EXP ”.
This medicine does not require any special storage conditions.
Din il- mediċini m’ għandhiex bżonn kundizzjonijiet speċjali ta ’ ħażna.
You must throw away the bottle 4 weeks after you first opened it, to prevent infections, and use a new bottle.
Biex tipprevjeni nfezzjonijiet għandek tarmi l- flixkun erba ’ ġimgħat wara li tkun ftaħtu l- ewwel darba, u tuża flixkun ġdid.
Write down the date you open 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.
These measures will help protect the environment.
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent.
What DuoTrav contains
X’ fih DuoTrav
The active substances are: travoprost 40 micrograms/ ml and timolol 5 mg/ ml.
Is- sustanzi attivi huma travoprost 40 mikrogramma/ ml u timolol 5 mg/ ml
Benzalkonium chloride, mannitol, trometamol, polyoxyethylene hydrogenated castor oil 40 (HCO-40), boric acid, disodium edetate, hydrochloric acid (to adjust pH), purified water.
Benzalkonium chloride, mannitol, trometamol, polyoxyethylene hydrogenated castor oil 40 (HCO- 40), boric acid, disodium edetate, hydrochloric acid (biex jikontrolla l- pH), ilma ppurifikat.
Tiny amounts of hydrochloric acid are added to keep acidity levels (pH levels) normal.
Jiġu miżjuda ammonti żgħar ta ’ hydrochloric acid biex iżommu l- livelli ta ’ l - acidita ’ (livelli tal- pH) normali.
What DuoTrav looks like and the contents of the pack
Id- Dehra ta ’ DuoTrav u l- kontenuti tal- pakkett.
DuoTrav 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 or six 2.5 ml plastic bottles with screw caps.
DuoTrav 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 jew sitt flixken tal- plastik ta ’ 2. 5 ml b’ għatu tal - kamin.
Each bottle is placed in a pouch.
Kull flixkun jinstab f’ pakkett ta ’ protezzjoni.
Manufacturer
Il- Manifattur
Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom
Boundary Way Hemel Hempstead Herts., HP2 7UD Ir- Renju Unit
Rijksweg 14 B-2870 Puurs Belgium
Rijskweg 14 B- 2870 Puurs Il- Belġju
Alcon Cusí, S. A., Camil Fabra 58, 08320 El Masnou, Spain
Alcon Cusí, S. A., Camil Fabra 58, 08320 El Masnou, Spanja
24 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
24 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’ XXXX.
EU number
Isem inventat
Strength
Daqs tal -
Pharmaceutical form
Numru ta ’ l- EU
Route of administration
Għamla farmaċewtika
Package size
pakkett
Powder for solution for Intravenous or intramuscular use injection
Trab għal soluzzjoni għall - injezzjoni
Powder and solvent for Intravenous or intramuscular use solution for injection
Trab u solvent għal soluzzjoni għall- injezzjoni
Powder: vial (glass) Solvent: ampoule(glass)
Ampulla (ħġieġ)
Vial (glass)
Kunjett (ħġieġ)
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk tixtieq aktar informazzjoni relatat mar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Dynastat?
X’ inhu Dynastat?
Dynastat is a medicine that contains the active substance parecoxib.
Dynastat huwa mediċina li fih is- sustanza attiva parecoxib.
It is available as a powder to be made up into a solution for injection, in vials containing 20 or 40 mg of parecoxib, with or without a solvent.
Jiġi bħala trab biex jinħall f’ soluzzjoni għall- injezzjoni, f’ kunjetti li jkun fihom 20 jew 40 mg parecoxib, b’ solvent jew mingħajr solvent.
What is Dynastat used for?
Għal xiex jintuża Dynastat?
Dynastat is used for the short-term treatment of pain after an operation.
Dynastat jintuża għat- trattament fil- qosor tal- uġigħ ta ’ wara operazzjoni.
How is Dynastat used?
Kif jintuża Dynastat?
Dynastat is given at a dose of 40 mg, followed by further doses of 20 or 40 mg as required every six to 12 hours, with a maximum dose of 80 mg a day.
Dynastat jingħata f’ doża ta ’ 40 mg, b’ dożi sussegwenti ta ’ 20 jew 40 mg kif meħtieġ f’ intervalli ta ’ bejn sitta jew tnax- il siegħa, b’ doża massima ta ’ 80 mg kuljum.
The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle.
L- injezzjoni tista ’ tingħata rapidament u direttament f’ vina jew f’ linja intravenuża (tubu rqiq infilzat f’ vina) jew inkella tingħata f’ muskolu bil- mod u fil- fond.
Dynastat can be given at the same time as opioid painkillers (medicines that are related to morphine).
Dynastat jista ’ jingħata fl- istess ħin mal- painkillers opjojdi (mediċini relatati mal - morfina).
The shortest duration possible and the lowest effective dose of Dynastat should be used.
Bħal mediċini oħra fl- istess grupp ta ’ Dynastat, ir- riskji fil- qalb u l- vini u l- arterji jistgħu jiżdiedu meta jingħataw dożi għolja u fit- tul ta ’ Dynastat għaldaqstant għandu jintuża l- iqsar żmien possibbli u tingħata l- inqas doża effettiva ta ’ Dynastat.
For elderly patients weighing less than 50 kg and for patients with moderate liver problems, treatment is with half the usual recommended dose of Dynastat, with a maximum daily dose of 40 mg.
Għall- pazjenti anzjani li jiżnu inqas minn 50 kg u għal pazjenti bi problemi moderati fil- fwied, it - trattament ikun nofs id- doża rakkomandata s- soltu ta ’ Dynastat, b’ doża massima ta ’ kuljum ta ’ 40 mg.
Dynastat must not be used in patients with severe liver problems.
Dynastat ma għandux jintuża f' pazjenti bi problemi gravi fil- fwied.
In patients with severe kidney problems or who are likely to develop fluid retention, treatment should start with the lowest dose and the patient’ s kidneys should be monitored closely.
Il- pazjenti li għandhom problemi serji fil- fwied jew għandhom it- tendenza li jiżviluppaw żamma ta ’ fluwidi, it- trattament għandu jibda bl- iżjed doża baxxa u l- kliewi tal- pazjent għandhom jiġu mmonitorjati mill- qrib.
Dynastat is not recommended for children or adolescents.
Dynastat mhux rakkomandat għall- użu fit- tfal jew l- adoloxxenti.
How does Dynastat work?
Kif jaħdem Dynastat?
The active substance in Dynastat, parecoxib, is a ‘ prodrug ’ of valdecoxib.
Is- sustanza attiva f’ Dynastat, parecoxib, hija ‘ prodroga ’ ta ’ valdecoxib.
This means that it is converted to valdecoxib in the body.
Dan ifisser li fil- ġisem tinbidel f’ valdecoxib.
Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘ cyclo-oxygenase-2 (COX-2) inhibitors’.
Valdecoxib huwa mediċina antinfjammatorja mhux sterojdali (NSAID) li tagħmel parti mill- grupp ta ’ mediċini magħrufa bħala ‘ inibituri tas- cyclo- oxygenase- 2 (COX- 2) ’.
It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Jimblokka l- enzim COX- 2, li jwassal għal tnaqqis fil- produzzjoni ta ’ prostaglandini, sustanzi li għandhom x’ jaqsmu mal - proċess infjammatorju.
By reducing the production of prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.
Bit- tnaqqis tal- produzzjoni tal- prostaglandini, Dynastat jgħin fit- tnaqqis tas - sintomi tal- infjammazzjoni, inkluż l- uġigħ.
How has Dynastat been studied?
Kif ġie studjat Dynastat?
The effectiveness of Dynastat in treating pain after an operation has been studied in 2,582 adults who had undergone a variety of surgical procedures including dental, orthopaedic (bone), gynaecological or coronary (heart) bypass surgery.
L- effikaċja ta ’ Dynastat fil- prevenzjoni tal- uġigħ ta ’ wara l- operazzjoni ġie studjat f’ 2, 582 adult li kienu sarulhom varjetà ta ’ proċeduri kirurġiċi inklużi dawk dentali, ortopediċi (fl- għadam), ġinekoloġiċi jew tal- bypass koronarja (tal- qalb).
Dynastat was compared with placebo (a dummy treatment) as well as with other painkillers such as ketorolac, morphine, valdecoxib, ibuprofen and tramadol.
Dynastat tqabbel mal- plaċebo (trattament finta) kif ukoll ma ’ mediċini oħra għal kontra l- uġigħ bħal ketorolac, morfina, valdecoxib, ibuprofen u tramadol.
Some of the studies also looked at the impact of giving Dynastat on the patient ’ s use of morphine for additional pain relief after surgery.
Xi ftit mill- istudji ħarsu wkoll lejn l- impatt tal- għoti ta ’ Dynastat fuq l- użu tal- morfina għal iktar serħan mill- uġigħ ta ’ wara l- operazzjoni.
The main measures of effectiveness were changes in pain scores as rated by the patients.
Il- mezzi ewlenin tal- kejl tal- effikaċja kienu t- tibdil fil - punteġġi tal- uġigħ kif valutati mill- pazjenti.
What benefit has Dynastat shown during the studies?
X’ inhu l- benefiċċju ta ’ Dynastat li ntwera f’ dawn l- istudji?
Dynastat was effective in relieving moderate to severe pain after an operation.
Dynastat kien effikaċi fis- serħan minn uġigħ ta ’ wara l- operazzjoni bejn moderat u serju.
It was generally more effective than placebo and as effective as other painkillers.
Ġeneralment kien iktar effikaċi mill- plaċebo u effikaċi daqs mediċini oħra ta ’ kontra l- uġigħ.
Dynastat was also shown to reduce the need for morphine, but this reduction did not seem to be accompanied with a reduction in the side effects associated with morphine.
Intwera li Dynastat inaqqas il- ħtieġa għall- morfina, iżda dan it- tnaqqis ma deherx li kien akkumpanjat minn tnaqqis fl - effetti sekondarji assoċjati mal- morfina.
What is the risk associated with Dynastat?
X’ inhu r- riskju assoċjat ma ’ Dynastat?
The most common side effects with Dynastat (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), agitation, insomnia (difficulty sleeping), hypoaesthesia (reduction in the sense of touch), high or low blood pressure, pharyngitis (sore throat), respiratory insufficiency (difficulty breathing), alveolar osteitis (inflammation after a tooth extraction), dyspepsia (indigestion), flatulence (wind), pruritus (itching), back pain, oliguria (low urine output), peripheral oedema (swelling, usually of the legs) and increase in blood creatinine levels (a marker of kidney problems).
L- iktar effetti sekondarji komuni ma ’ Dynastat (li dehru f’ bejn pazjent 1 u għaxra min kull 100) huma l- anemija (tnaqqis fl- għadd ta ’ ċelloli ħomor tad- demm), ipokaljemija (livelli baxxi ta ’ potassju fid - demm), aġitazzjoni, insonnja (diffikultà fl- irqad), ipoestesija (tnaqqis fis- sens tal- mess), pressjoni għolja jew baxxa, farinġite (griżmejn irritati), insuffiċjenza respiratorja (diffukultà biex tieħu n- nifs), osteite alveolari (infjammazzjoni wara l- qlugħ ta ’ sinna), dispepsjia (indiġestjoni), flatulenza (gass fl - istonku), ħakk, uġigħ fid- dahar, oligurja (tnaqqis fl- ammont ta ’ awrina), edema periferika (nefħa, ġeneralment fir- riġlejn) u żieda fil- livelli ta ’ kreatinina fid- demm (sinjal ta ’ problemi fil- kliewi).
For the full list of all side effects reported with Dynastat, see the Package Leaflet.
Għal - lista sħiħa tal- effetti sekondarji kollha rrappurtati ma ’ Dynastat, ara l- Fuljett ta ’ Tagħrif.
Dynastat should not be used in people who may be hypersensitive (allergic) to parecoxib or any of the other ingredients.
Dynastat m’ għandux jintuża għal persuni li jistgħu jkunu allerġiċi għal parecoxib jew għal kwalunkwe mill- ingredjenti l- oħra.
Dynastat must not be used in patients with:  a history of serious allergic reactions to medicines, especially skin reactions;  stomach ulcers or bleeding in the stomach or gut;  allergic-type reactions such as asthma, cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;  severe liver disease;  inflammatory bowel disease;  heart failure (an inability of the heart to pump enough blood around the body), heart disease, peripheral artery disease (obstruction of the arteries in the arms or legs), or cerebrovascular disease (problems affecting the blood vessels in the brain).
Dynastat m’ għandux jintuża f’ pazjenti li għandhom:  Storja ta ’ reazzjonijiet allerġiċi għal mediċini, speċjalment reazzjonijiet tal- ġilda;  Ulċeri fl- istonku jew ħruġ ta ’ demm fl- istonku jew fl- imsaren;  Reazzjonijiet tat- tip allerġiku bħall- ażma, sintomi jixbhu lil dawk tar- riħ, qarnit fl- imnifsejn, nefħa fil- wiċċ jew ħorriqija wara t- teħid tal- aspirina jew l- NSAIDs inklużi inibituri COX- 2 oħra;  Mard serju tal- fwied;  Mard infjammatorju tal- imsaren;  Insuffiċjenza kardijaka (inabilità tal- qalb biex tippompja demm biżżejjed fil- ġisem), mard tal - qalb, mard periferiku tal- arterji (sadd tal- arterji fl- idejn u s- saqajn), jew mard ċerebrovaskulari (problemi li jaffettwaw il- vini u l- arterji tal- moħħ).