qanastek/EMEA-V3 huggingface dataset:
DULOXETINE BOEHRINGER INGELHEIM may cause a sensation of restlessness or an inability to sit or stand still.
DULOXETINE BOEHRINGER INGELHEIM jista ’ jikkawża sensazzjoni ta ’ irrekwitezza jew l - inkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq.
Use in children and adolescents under 18 years of age DULOXETINE BOEHRINGER INGELHEIM should normally not be used for children and adolescents under 18 years.
Użu fit- tfal jew adolexxenti taħt it- tmintax- il sena Normalment DULOXETINE BOEHRINGER INGELHEIM m’ għandux jintuza fit- tfal u f’ adolexxenti taħt it- tmintax- il sena.
Despite this, your doctor may prescribe DULOXETINE BOEHRINGER INGELHEIM for patients under 18 because he/ she decides that this is in their best interests.
Madankollu, it- tabib tiegħek jista ’ jordna DULOXETINE BOEHRINGER INGELHEIM lil pazjenti taħt it- 18 għax jiddeċiedi/ tiddeċiedi li huwa fl- aħjar interess għalihom.
If your doctor has prescribed DULOXETINE BOEHRINGER INGELHEIM for a patient under 18 and you want to discuss this, please go back to your doctor.
Jekk it- tabib ordna DULOXETINE BOEHRINGER INGELHEIM għal pazjent taħt it- 18 u tixtieq xi spjegazzjonijiet, jekk jogħġbok erġa ’ mur għand it- tabib tiegħek.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking DULOXETINE BOEHRINGER INGELHEIM.
Għandek tavża lit- tabib tiegħek jekk jiżviluppaw jew jiggravaw xi sintomi li ssemmew hawn fuq, meta pazjenti taħt it- 18 ikunu qegħdin jieħdu DULOXETINE BOEHRINGER INGELHEIM.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of DULOXETINE BOEHRINGER INGELHEIM in this age group have not yet been demonstrated.
Barra minn hekk, f’ dan il- grupp ta ’ età, l- effetti tas- sigurtà fit- tul għadhom ma ġewx ippruvati, f’ dak li għandu x’ jaqsam l- iżvilupp tal- ġisem, il- maturazzjoni, u l- iżvilupp kemm konjittiv kif ukoll tal- mod ta ’ komportament.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
98 Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed/ qiegħda tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk ta ’ mingħajr riċetta.
The main ingredient of DULOXETINE BOEHRINGER INGELHEIM, duloxetine, is used in other medicines for other conditions (depression and urinary incontinence).
Is- sustanza l- aktar importanti f’ DULOXETINE BOEHRINGER INGELHEIM, duloxetine, hija użata f’ medicini oħra għal kundizzjonijiet oħra (depressjoni u inkontinenza urinarja).
Using more than one of these medicines at the same time should be avoided.
L- użu ta ’ iżjed minn wieħed minn dawn il- medicini fl- istess żmien għandu jkun evitat.
Your doctor should decide whether you can take DULOXETINE BOEHRINGER INGELHEIM with other medicines.
It- tabib tiegħek irid jiddeċiedi jekk għandekx tieħu DULOXETINE BOEHRINGER INGELHEIM ma ’ mediċini oħra.
92 Monoamine Oxidase Inhibitors (MAOIs):
Inibituri ta ’ Monoamine Oxidase( MAOI):
You should not take DULOXETINE BOEHRINGER INGELHEIM if you are taking, or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
M’ għandekx tieħu DULOXETINE BOEHRINGER INGELHEIM jekk qiegħed/ qiegħda tieħu jew ħadt recentament f’ dawn l- aħħar 14- il ġurnata, xi mediċina oħra kontra d- depressjoni msejħa inibitur ta ’ monamino oxidase.
Taking a MAOI together with many prescription medicines, including DULOXETINE BOEHRINGER INGELHEIM, can cause serious or even life-threatening side effects.
It- teħid ta 'xi MAOI flimkien ma' ħafna mill- mediċini mgħotija bir- riċetta, inkluż DULOXETINE BOEHRINGER INGELHEIM, jista ’ jikkawża effetti sekondarji serji jew li jkunu ta ’ periklu għall- ħajja.
Also, you need to wait at least 5 days after you stop taking DULOXETINE BOEHRINGER INGELHEIM before you take a MAOI.
Għandek bżonn ukoll tistenna ta 'l- anqas 5 ijiem wara li tieqaf tieħu DULOXETINE BOEHRINGER INGELHEIM biex tkun tista' tieħu xi MAOI.
These would include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, antihistamines.
Dawn jinkludu mediċini mogħtija mit- tabib tiegħek permezz ta ’ ricetta inklużi l- benżodijażepini, mediċini qawwijin kontra l- uġigħ, antipsikotiċi, phenobarbital u anti- istaminiċi.
You should tell your doctor if you are taking oral – anticoagulants (medicines which thin the blood).
Għandek tgħid lit- tabib tiegħek jekk qiegħed/ qiegħda tieħu xi antikoagulanti orali (mediċini li jraqqu d- demm).
Care should be taken if you drink alcohol while you are being treated with DULOXETINE BOEHRINGER INGELHEIM.
Għandek toqgħod attent jekk tixrob l- alkoħol waqt li tkun qiegħed/ qiegħda tirċievi l- kura b’ DULOXETINE BOEHRINGER INGELHEIM.
You should use DULOXETINE BOEHRINGER INGELHEIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk issir tqila jew qiegħda tipprova ssir tqila, waqt li qiegħda tieħu DULOXETINE BOEHRINGER INGELHEIM. Ghandek biss tuża DULOXETINE BOEHRINGER INGELHEIM wara li tkun iddiskutejt mat- tabib tiegħek il- benefiċċji possibbli u kull riskju possibbli għat- tarbija li għada ma twelditx.
The use of DULOXETINE BOEHRINGER INGELHEIM while breastfeeding is not recommended.
M’ huwiex rakkomandat l- użu ta ’ DULOXETINE BOEHRINGER INGELHEIM waqt it- treddigħ.
Driving and using machines DULOXETINE BOEHRINGER INGELHEIM may make you feel sleepy of dizzy.
Sewqan u tħaddim ta ’ magni Tista ’ tħossok bi ngħas jew sturdut minħabba DULOXETINE BOEHRINGER INGELHEIM Issuqx u tagħmilx użu minn għodda jew tħaddem magni sakemm tkun taf b’ liema mod jaffettwak DULOXETINE BOEHRINGER INGELHEIM.
Do not drive or use any tools or machines until you know how DULOXETINE BOEHRINGER INGELHEIM affects you.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ DULOXETINE BOEHRINGER INGELHEIM
Important information about some of the ingredients of DULOXETINE BOEHRINGER INGELHEIM DULOXETINE BOEHRINGER INGELHEIM contains sucrose.
99 DULOXETINE BOEHRINGER INGELHEIM fih s- sucrose.
Always take DULOXETINE BOEHRINGER INGELHEIM exactly as your doctor has told you.
Dejjem għandek tieħu DULOXETINE BOEHRINGER INGELHEIM skond il- parir tat- tabib.
The usual dose of DULOXETINE BOEHRINGER INGELHEIM is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Id- doża ta ’ DULOXETINE BOEHRINGER INGELHEIM li ssoltu tingħata hija ta ’ 60 mg darba kuljum, iżda t- tabib jiktiblek ricetta skond id- doza li tgħodd għalik.
93 DULOXETINE BOEHRINGER INGELHEIM is for oral use.
DULOXETINE BOEHRINGER INGELHEIM għandu jittieħed mill- ħalq.
Talk with your doctor about how long you should keep taking DULOXETINE BOEHRINGER INGELHEIM.
Tkellem mat- tabib tiegħek dwar kemm trid iddum tieħu DULOXETINE BOEHRINGER INGELHEIM. Tieqafx tieħu DULOXETINE BOEHRINGER INGELHEIM mingħajr ma tkellem lit - tabib tiegħek.
Do not stop taking DULOXETINE BOEHRINGER INGELHEIM without talking to your doctor.
Jekk tieħu DULOXETINE BOEHRINGER INGELHEIM aktar milli suppost
If you take more DULOXETINE BOEHRINGER INGELHEIM than you should Call your doctor or pharmacist immediately if you take more than the amount of DULOXETINE BOEHRINGER INGELHEIM prescribed by your doctor.
Ċempel immedjatament lit- tabib jew lill- ispiżjar tiegħek jekk tieħu aktar ammont ta 'DULOXETINE BOEHRINGER INGELHEIM minn kemm ordnalek it- tabib.
If you forget to take DULOXETINE BOEHRINGER INGELHEIM Do not take a double dose to make up for a forgotten dose.
Jekk tinsa tieħu DULOXETINE BOEHRINGER INGELHEIM M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
If your doctor thinks that you no longer need DULOXETINE BOEHRINGER INGELHEIM he will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Jekk it- tabib tiegħek jaħseb li m' għadx għandek bżonn tieħu DULOXETINE BOEHRINGER INGELHEIM huwa se jgħidlek biex tnaqqas id- doża fuq perijodu ta ’ għallinqas ġimgħatejn qabel ma twaqqaf għal kollox il- kura.
Some patients who stop taking DULOXETINE BOEHRINGER INGELHEIM suddenly have had symptoms such as dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo.
Xi pazjenti li waqqfu jieħdu DULOXETINE BOEHRINGER INGELHEIM f' daqqa kellhom sintomi bħal sturdament, sensazzjonijiet ta ’ tniggiż, problemi ta ’ irqad( ħolm stramb, ħmar il- lejl, ma tkunx tista ’ torqod), iħossuhom irrekweti u aġitati, iħossuhom ansjużi, iħossuhom ħażin (dardir) jew jgħamillhom ħażin (rimettar), tregħid (ċaqliq ripetut) uġigħ ta 'ras, iħossuhom irritabbli, dijarea, għaraq esaġerat jew vertigo.
Very common side effects (these can affect more than 10 in 100 patients treated) Feeling sick (nausea), somnolence, headache, dizziness and constipation.
Efetti sekondarji komuni ħafna (dawn jistgħu jaffettwaw iżjed minn pazjent 1 minn kull 10 pazjenti kkurati) Tħossok ma tiflaħx (tqalligħ), uġigħ ta ’ ras, nixfa fil- ħalq u tħossok bi ngħas,
Common side effects (these can affect from 1 to 10 users in 100 patients treated) • Tiredness, trouble sleeping, anxiety, feeling agitated or having abnormal dreams. • Dizziness, tremor or numbness, including numbness or tingling of the skin. • Diarrhoea, constipation, being sick (vomiting), heartburn, breaking wind, stomach pain. • Tinnitus (perception of sound in the ear when there is no external sound). • Blurred eyesight. • Feeling the heart pumping in the chest, flushing, increased sweating, night sweats • Problems getting an erection, less sex drive. • (Itchy) rash. • Muscle pain, muscle tightness, muscle spasm. • Increased yawning.
100 Effetti sekondarji komuni (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 100 pazjent ikkurat) • Għeja, diffikultà biex torqod, ansjetà, tħossok aġitat u jkollok ħolm mhux tas- soltu. • Sturdament, rogħda jew tirżiħ, inkluż it- tirżiħ jew tnemnin tal- ġilda • Dijarea, stitikezza, tħossok ma tiflaħx (rimettar), ħruq ta ’ l- istonku, tgħaddi l- arja, uġigħ fl - istonku. • Tinnitus (is- sensazzjoni ta ’ ħsejjes fil- widnejn meta m’ hemm ebda ħoss madwarek) • Vista mċajpra • Tħoss il- qalb tħabbat f’ sidrek, ħmura fil- wiċċ, tegħreq iżjed, tegħreq matul il- lejl. • Problemi biex ikollok erezzjoni, tnaqqis fil- ħajra għas- sess. • Raxx (bil- ħaqq) • Uġigħ fil- muskoli, riġidità fil- muskoli, spażmu fil- muskolu. • Tittewweb iżjed mis- soltu. • Imurlek l- aptit, tnaqqis fil- piż.
Uncommon side effects (these can affect from 1 to 10 users in 1,000 patients treated) • Throat inflammation. • Feeling disorientated, feeling sleepy, lack of motivation. • Tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking. • Poor sleep quality • Burping, indigestion, gastroenteritis • Vertigo, ear pain. • Inflammation of the liver that may cause abdominal pain • Large pupils (the dark centre of the eye), visual disturbance. • Fast or irregular heart beat • Sexual problems, including changes in ejaculation, orgasm. • Abnormal periods, including heavy or prolonged periods. • Allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight • Increase in blood pressure, feeling cold in your fingers and/ or toes, feeling dizzy (particularly when standing up too quickly), cold sweats, shivering or fainting. • An increased level of sugar in the blood. • Need to pass more urine than normal, need to pass urine during the night, difficulty or inability to pass urine or having an urine flow decreased. • Grinding of teeth, feeling hot/ cold, thirst, throat tightness, nose bleeds. • Weight gain.
Effetti sekondarji mhux komuni( dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn 1, 000 pazjent ikkurat) • Infjammazzjoni tal- gerżuma. • Tħossok diżorjentat, tħossok bi ngħas, nuqqas ta ’ motivazzjoni. • Ttiegħem l- affarijiet differenti mis- soltu, disturbi ta ’ attenzjoni, ebusija, spażmi u movimenti involontarji tal- muskoli, ġbid involontarju tal- muskoli, timxi b’ mod mhux normali. • Kwalità hażina ta ’ irqad • Tfewwiq, indiġestjoni, gastroenterite. • Vertigo, uġigħ fil- widnejn. • Infjammazzjoni tal- fwied li tista ’ tkun il- kawża ta ’ uġigħ addominali. • Il- ħabba ta ’ l- għajn tkun kbira (iċ- centru skur ta ’ l- għajnejn), disturbi fil- vista. • Tħabbit mgħaġġel jew irregolari tal- qalb. • Problemi sesswali, li jinkludu bdil fl- eġakulazzjoni jew fl- orgażmu, • Pirjids mhux tas- soltu, li jinkludu pirjids b’ ħafna demm jew li jdumu • Reazzjonijiet allerġiċi, tendenza ogħla li titbenġel, infafet jew sensittività għad- dawl tax- xemx. • Żieda fil- pressjoni tad- demm, tħoss is- swaba ’ ta ’ idejk jew/ u ta ’ saqajk kesħin, tħossok se tistordi (speċjalment meta tqum bil- wieqfa malajr wisq), tħoss l- għaraq ixoqq għalik, tregħid jew ħass ħażin. • Jiżdied il- livell taz- zokkor fid- demm • Il- bżonn li tgħaddi iżjed awrina mis- soltu, il- bżonn li tgħaddi l- awrina matul il- lejl, diffikultà jew inabbiltà biex tgħaddi l- awrina jew ikun hemm tnaqqis fil- fluss ta ’ l- awrina. • Tagħżiż tas- snien, tħossok sħun/ kiesaħ, għatxan, rassa fil- gerżuma, tinfaraġ. • Żieda fil- piż.
Rare side effects (these can affect from 1 to 10 users in 10,000 patients treated) • Decrease of activity of the thyroid gland. • Dehydration. • Mania (a disorder which symptoms are over activity, racing thoughts and decrease need for sleep). • Bad breath. • Increased pressure in the eye. • Menopausal symptoms. • Contraction of the jaw muscle. • Increased level of cholesterol in the blood, low levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused), syndrome of inadequate secretion of anti-diuretic hormone (SIADH).
Effetti sekondarji rari (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 10, 000 pazjent ikkurat) • Tnaqqis fl- attività tal- glandola tat- tirojde. • Diżidratazzjoni • Manija (marda fejn is- sintomi huma li tkun attiv iżżejjed, ikollok ħsibijiet li jiġru bik u jonqos il- bżonn ta ’ l- irqad). • Riħa ħażina fil- ħalq • Żieda tal- pressjoni fl- għajnejn. • Sintomi tal- menopawża. • Kontrazzjoni tal- muskolu tax- xedaq. • Żieda fil- livell tal- kolesterol fid- demm, livelli baxxi ta ’ sodium fid- demm (is- sintomu huma tħossok ma tiflaħx u m’ intix f’ sikktek bil- muskoli dgħajfin jew konfuż), sindromu ta ’ sekrezzjoni insuffiċjenti ta ’ l- ormon kontra d- djuresi (SIADH).
Other possible side effects • Hallucinations, suicidal thoughts, behaviour aggression and anger. • A sensation of restlessness or an inability to sit or stand still or “ Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits. • Passing bright red blood in your stools, vomiting blood, or black tarry stools (faeces). • Having abnormal urine odour. • Chest pain. • Yellow colouration of the skin (jaundice), hepatic failure, Stevens-Johnson syndrome, sudden swelling of skin or mucosa (angioedema).
Sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq jew “ Is- Sindromu ta ’ Serotonin ” (reazzjoni rari li tista ’ tikkawza sensazzjonijiet ta ’ kuntentezza kbira, ħedla, guffaġni, irrekwitezza, sensazzjoni bħallikieku fis- sakra, deni, muskoli riġidi jew għarqana), aċċessjonijiet.
Keep out of the reach and sight of children 95 Do not use DULOXETINE BOEHRINGER INGELHEIM after the expiry date which is stated on the carton.
Tużax DULOXETINE BOEHRINGER INGELHEIM wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Store in the original package.
Żomm fil- pakkett oriġinali.
What DULOXETINE BOEHRINGER INGELHEIM contains The active substance is duloxetine.
X’ fih DULOXETINE BOEHRINGER INGELHEIM:
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Kull kapsula fiha 30mg jew 60mg ta ’ duloxetine (bħala hydrochloride).
What DULOXETINE BOEHRINGER INGELHEIM looks like and contents of the pack DULOXETINE BOEHRINGER INGELHEIM is a hard gastro-resistant capsule Each capsule of DULOXETINE BOEHRINGER INGELHEIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Kull kapsula ta ’ DULOXETINE BOEHRINGER INGELHEIM fiha pritkuni ta ’ duloxetine hydrochloride b’ kisja sabiex tipproteġihom mill- aċtu ta ’ l- istonku.
DULOXETINE BOEHRINGER INGELHEIM is available in two strengths:
DULOXETINE BOEHRINGER INGELHEIM issibu f’ żewġ dożi:
The 60 mg capsules has an opaque green body, imprinted with ‘ 60 mg’ and an opaque blue cap, imprinted with ‘ 9542’.
30mg u 60 mg Il- kapsuli ta ’ 30mg għandhom il- parti prinċipali abjad opak stampati b ’ ‘ 30mg ’ u l- parti ta ’ fuq blu opak stampati b ’ ‘ 9543 ’ Il- kapsuli ta ’ 60mg għandhom il- parti prinċipali aħdar opak stampati b ’ ‘ 60mg ’ u l- parti ta ’ fuq blu opak stampati b ’ ‘ 9542 ’
DULOXETINE BOEHRINGER INGELHEIM 60 mg is available in packs of 28 and 98 capsules.
DULOXETINE BOEHRINGER INGELHEIM 30mg issibu f’ pakketti ta ’ 7, 28 u 98 kapsula DULOXETINE BOEHRINGER INGELHEIM 60 mg issibu f’ pakketti ta ’ 28 u 98 kapsula.
Not all pack sizes may be marketed.
102 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
173 D-55216 Ingelheim am Rhein, Germany.
173 D- 55216 Ingelheim am Rhein, Il- Ġermanja.
Suomi/ Finland Boehringer Ingelheim Finland Ky Puh/ Tel: +358 10 310 2800
Puh/ Tel: +358 10 310 2800
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
98
104
EU number
Numru tal- EU
Pharmaceutical Form
Isem Ivvintat Qawwa
Route of administration
Għamla Farmaċewtika Mnjen jingħata
Content (concentration)
Il- Kontenut (Konċentrazzjoni) Daqs tal- pakkett
40 µg / ml + 5 mg/ ml
40 µg / ml+ 5 mg/ ml
Eye drops, solution
Qtar għall- għajnejn, soluzzjoni
Bottle (polypropylene)
Użu għall- għajnejn
2.5 ml (40 µg / ml + 5 mg/ ml)
Flixkun (polypropylene) 2. 5 ml (40 µg / ml+ 5 mg/ ml)
1 bottle
Flixkun
Bottle (polypropylene
Użu għall- għajnejn
3 bottles
3 flixken
6 bottles
6 flixken
DuoTrav 40 micrograms/ ml + 5mg/ ml eye drops, solution
DuoTrav 40 mikrogramma/ ml + 5 mg/ ml qtar għall- għajnejn, soluzzjoni.
1 ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate)
1 ml ta ’ soluzzjoni fih 40 mikrogramma ta ’ travaprost u 5 mg ta ’ timolol (bħala timolol maleate)
Excipients: benzalkonium chloride 0.15 mg, polyoxyethylene hydrogenated castor oil 40 (HC0-40) 5 mg (see section 4.4)
Benzalkonium Chloride 0. 15 mg, polyoxyethylene hydrogenated castor oil 40 (HCO- 40) 5 mg (ara sezzjoni 4. 4)
Eye drops, solution (eye drops) Clear, colourless solution
Qtar għall- għajnejn, soluzzjoni (qtar għall- għajnejn)
Decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues (see Section 5.1).
Tnaqqis tal- pressjoni fl- għajnejn (IOP) f’ pazjenti bi glawkoma tat- tip open- angle jew pressjoni għolja ta ’ l- għajnejn li ma rrispondewx b’ mod suffiċjenti b’ kura topika ta ’ imblokkaturi tar- riċetturi beta jew analogi ta ’ prostaglandin (ara sezzjoni 5. 1).
Use in adults, including the elderly The dose is one drop of DuoTrav in the conjunctival sac of the affected eye(s) once daily, in the morning or evening.
Użu fl- adulti, inkluż l- anzjani Id- doża hija ta ’ qatra waħda ta ’ DuoTrav ġewwa l- borża konġunktivali ta ’ l- għajn/ ejn affetwata/ i darba kuljum, filgħodu jew filgħaxija.
It should be administered at the same time each day.
Id- doża għandha tittieħed kuljum fl- istess ħin.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended.
Wara l- għoti huwa rakkomandat okklużjoni nasolakrimali jew li l- kappell tal- għajn jingħalaq bil- mod.
This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Dan jista ’ jnaqqas l- assorbiment sistemiku tal- prodotti mediċinali mill- għajn u jirriżulta fi tnaqqis tar- reazzjonijiet avversi sistemiċi.
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart (see section 4.5).
Jekk ikun qed jintuża iktar minn prodott topiku wieħed fl- għajnejn, għandu jkun hemm interval ta ’ mill- anqas 5 minuti bejn l- għoti tal- prodotti mediċinali (ara sezzjoni 4. 5).
If a dose is missed, treatment should be continued with the next dose as planned.
Jekk tintnesa xi doża, l- kura għandha titkompla bid- doża li jmiss kif ippjanat.
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).
When substituting another ophthalmic antiglaucoma agent with DuoTrav, the other agent should be discontinued and DuoTrav should be started the following day.
Meta sustanza oħra ta ’ l- għajnejn li tintuża kontra l- glawkoma tiġi mibdula għal DuoTrav, l- użu tas - sustanza l- oħra għandu jitwaqqaf, u DuoTrav għandu jinbeda l- ġurnata ta ’ wara.
Paediatric patients The efficacy and safety of DuoTrav in patients below the age of 18 years have not been established and its use is not recommended in these patients until further data become available.
Pazjenti tfal L- effikaċja u s- sigurtà ta ’ DuoTrav f’ pazjenti taħt l- età ta ’ 18- il sena ma ’ ġewx stabbiliti u l- użu tiegħu mhux rakkomandat f’ dawn il- pazjenti qabel ma jkun disponibbli aktar tagħrif.
Use in hepatic and renal impairment No studies have been conducted with DuoTrav or with timolol 5 mg/ ml eye drops in patients with hepatic or renal impairment.
Użu f’ pazjenti b’ indeboliment epatiku u renali Ma saru l- ebda studji b’ DuoTrav jew timolol 5 mg/ ml qtar għall- għajnejn f’ pazjenti b’ indeboliment epatiku jew renali.
2 Travoprost 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).
2 Travoprost kien studjat f’ pazjenti b’ indeboliment epatiku ħafif sa sever u f’ pazjenti b’ indeboliment renali ħafif sa sever (tneħħija tal- krejatinina b’ livell baxx sa 14 ml/ min).
No dosage adjustment was necessary in these patients.
Ma kienx hemm bżonn aġġustament fid- dożaġġ f’ dawn il- pazjenti.
For ocular use.
Għall- użu fl- għajnejn.
The patient should remove the protective overwrap immediately prior to initial use.
Il- pazjent għandu jneħħi il- pakkett ta ’ protezzjoni eżatt qabel ma jintuża għall- ewwel darba.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Biex tiġi evitata kontaminazzjoni tat- tarf tal- qattara u tas- soluzzjoni, għandu jkun hemm attenzjoni biex il - kappell ta ’ l- għajn, il- postijiet tal- madwar jew superfiċji oħra ma jitmessewx bit- tarf tal- qattara tal - flixkun.
Hypersensitivity to travoprost, timolol, or to any of the excipients.
Sensittività eċċessiva għal travoprost, timolol jew għal xi sustanzi mhux attivi.
Bronchial asthma, a history of bronchial asthma or severe chronic obstructive pulmonary disease.
Ażżma tal- bronki, passat ta ’ ażżma tal- bronki jew marda kronika severa ta ’ sadd pulmonari.
Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
Bradikardja tas- sinus, sadd atrioventrikolari tat- tieni jew tat- tielet grad, insuffiċjenza kardijaka ċara, jew xokk kardjoġeniku.
Severe allergic rhinitis and bronchial hyper reactivity; corneal dystrophies; hypersensitivity to other beta-blockers.
Rinite allerġika severa u reattività eċċessiva tal- bronki; distrofiji tal- korneja; sensittività eċċessiva għall- imblokkaturi tar- riċetturi beta oħra.
Systemic effects Like other topically applied ophthalmic agents, travoprost and timolol are absorbed systemically.
Effetti sistemiċi Bħal mediċini oħra għall- għajnejn applikati b’ mod topiku, travoprost u timolol jiġu asorbiti sistemikament.
Due to the beta-adrenergic component, timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta adrenergic blocking agents may occur.
Minħabba il- komponent beta- adrenergiku, timolol, jistgħu jseħħu l- istess tipi ta ’ reazzjonijiet avversi kardjovaskulari u pulmonari kif osservati b’ imblokkaturi adrenerġiċi tar- riċetturi beta.
Cardiac failure should be adequately controlled before beginning therapy with timolol.
Insuffiċjenza kardijaka għandha tiġi kkontrollata b’ mod adekwat qabel ma tinbeda t- terapija b’ timolol.
Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates checked.
Pazjenti b’ passat ta ’ mard kardijaku sever għandhom jiġu osservati għal sinjali ta ’ insuffiċjenza kardijaka u r- rata tal- polz tagħhom għandha tiġi ċċekkjata.
Respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and, rarely, death in association with cardiac failure, have been reported following administration of timolol maleate.
Reazzjonijiet respiratorji u tal- qalb, inkluż mewt minħabba spasmu tal- bronki f’ pazjenti bl- ażżma u rarament mewt assoċjat ma ’ insuffiċjenza kardijaka, ġew irrapportati wara l- għoti ta ’ timolol maleate.
Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycaemia or to diabetic patients (especially those with labile diabetes) as beta-adrenergic blocking agents may mask the signs and symptoms of acute hypoglycaemia.
Imblokkaturi adrenerġiċi tar - riċetturi beta għandhom jingħataw b’ attenzjoni f’ pazjenti soġġetti ipogliċemija spontanja jew f’ pazjenti dijabetiċi (speċjalment dawk b’ dijabete mhux stabbli) peress li mblokkaturi adrenerġiċi tar - riċetturi beta jistaw jaħbu s- sinjali u s- sintomi ta ’ ipogliċemija akuta.
They may also mask the signs of hyperthyroidism and cause worsening of Prinzmetal angina, severe peripheral and central circulatory disorders and hypotension.
Jistgħu wkoll jaħbu s- sinjali ta ’ ipertajrojdiżmu u jikkawżaw l- aggravar ta ’ anġina Prinzmetal, disturbi severi fis- sistema taċ - ċirkulazzjoni periferali u ċentrali u pressjoni baxxa.
Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin.
Prostaglandins u analogi ta ’ prostaglandin huma materjali attivi bijoloġikament li jistgħu jiġu assorbiti mill- ġilda.
Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle.
Nisa li huma tqal jew li qed jippruvaw joħorġu tqal għandhom jużaw prekawzjonijiet xierqa biex jevitaw esponiment dirett għall- kontenut tal- flixkun.
In the unlikely event of coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the exposed area immediately
F’ kas mhux probabbli li tiġi f’ kuntatt ma ’ porzjon sostanzjali tal- kontenut tal- flixkun, naddaf sew l- erja esposta immedjatament.
Anaphylactic reactions While taking beta adrenergic blocking agents, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.
Reazzjonijiet Anafilattiċi Waqt li qed jittieħdu mblokkaturi adrenerġiċi tar- riċetturi beta, pazjenti b’ passat ta ’ atopija jew passat ta ’ reazzjoni anafilattika severa għal varjeta ta ’ allerġeni jistgħu ma jirrispondux għad- dożi tas- soltu ta ’ adrenalina wżati għal kura ta ’ reazzjonijiet anafilattiċi.
Concomitant therapy Timolol may interact with other medicinal products (see section 4.5).
Terapija fl- istess waqt Timolol jista ’ jkollu effett fuq prodotti mediċinali oħra (ara sezzjoni 4. 5)
The effect on intraocular pressure or the known effects of systemic beta-blockade may be potentiated when DuoTrav is given to patients already receiving an oral beta-blocking agent.
L- effett fuq il- pressjoni ġewwa l- għajn jew l- effetti magħrufa ta ’ imblokk sistemiku tar- riċetturi beta jistgħu jiġu miżjuda meta DuoTrav jingħata lil pazjenti li diġa qed jieħdu mblokkaturi tar- riċetturi beta mill- ħalq.
The use of two local beta-adrenergic blocking agents or two local prostaglandins is not recommended.
Mhux irrakkomandat l- użu ta ’ żewġt imblokkaturi adrenerġiċi tar- riċetturi beta lokali jew ta ’ żewġt prostaglandins lokali.
3 Ocular effects Travoprost may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes.
3 Effetti fl- għajnejn Travoprost b’ mod gradwali jista ’ jbiddel il- kulur tal- għajn billi jżid in- numru ta ’ melanożomi (granijiet tal- pigment) fil- melanoċiti.
Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour.
Qabel ma tinbeda l- kura, il- pazjenti għandhom jiġu nfurmati bil - possibbiltà ta ’ bidla permanenti fil- kulur ta ’ għajn.
Unilateral treatment can result in permanent heterochromia.
Kura f’ għajn waħda jista ’ jirriżulta f’ eterokromja permanenti.
The long-term effects on the melanocytes and any consequences thereof are currently unknown.
L- effetti ta ’ lżmien twil fuq il- melanoċiti u l- konsegwenzi ta ’ dan s’ issa għadhom mhumiex magħrufa.
The change in iris colour occurs slowly and may not be noticeable for months to years.
Il- bidla fil- kulur tal- ħabba tal- għajn iseħħ bil- mod, u jista ’ ma jidhirx għal xhur sa snin.
The change in eye colour has predominantly been seen in patients with mixed coloured irides, i. e., blue-brown, grey-brown, yellow-brown and green-brown; however, it has also been observed in patients with brown eyes.
Il- bidla fil- kulur tal- għajn kien osservat l- aktar f’ pazjenti li għandhom il- ħabba ta ’ għajnejhom ta ’ kulur imħallat; i. e., blu- kannella, griż- kannella, isfar- kannella u aħdar- kannella; madankollu, dan deher ukoll f’ pazjenti li għanhom għajnejhom kannella.
Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish.
Tipikament, il- pigmentazzjoni kannella ta ’ madwar il- pupilla tinfirex b’ mod konċentriku lejn in- naħa ta ’ barra fl- għajnejn affetwati, iżda l- ħabba tal- għajn kollha jew partijiet minnha jistgħu jsiru aktar kannella.
After discontinuation of therapy, no further increase in brown iris pigment has been observed.
Wara li twaqqfet it- terapija, ma kienx osservat aktar żjieda fil- pigment kannella tal- ħabba tal- għajn.
In controlled clinical trials, periorbital and/ or eyelid skin darkening in association with the use of travoprost has been reported.
Fi provi kliniċi kkontrollati, kien irrapportat li l- ġilda ta ’ madwar l- għajnejn u/ jew tal- kappell tal- għajn skuraw fil- kulur f ’ assoċjazzjoni ma ’ l- użu ta ’ travoprost.
Travoprost may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/ or number of lashes.
Travaprost b’ mod gradwali jista ’ jbiddel ix- xagħar tal- għajn( ejn) ikkurati; dawn it- tibdiliet kienu osservati f’ madwar nofs il- pazjenti fil- provi kliniċi u jinkludu: żjieda fit- tul, ħxuna, pigmentazzjoni u/ jew ammont ta ’ xagħar tal- għajnejn.
The mechanism of eyelash changes and their long term consequences are currently unknown.
Il- mekkaniżmu ta ’ tibdil fix- xagħar tal- għajnejn u l - konsegwenzi fit- tul ta ’ dan it- tibdil s’ issa għandhom mhumiex magħrufa.
Travoprost has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey.
Fi studji li saru fuq xadini intwera li travoprost jikkawża tkabbir żgħir fil- fetħa tal- palpebra.
However, this effect was not observed during the clinical trials and is considered to be species specific.
Madankollu, dan l- effett ma ’ kienx osservat fil- provi kliniċi u huwa meqjus li hu speċifiku għal din l - ispeċi.
There is no experience of DuoTrav in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.
M’ hemm l- ebda esperjenza ta ’ DuoTrav f’ kundizzjonijiet ta ’ infjammazzjoni fl- għajnejn; l- anqas fi glawkona neovaskulari, angle- closure, narrow- angle jew konġenitali u hemm biss esperjenza limitata f’ mard ta ’ l- għajnejn ikkawżat mit- tirojde, fi glawkoma open- angle f’ pazjenti psewdofakiċi u fi glawkoma pigmentarja jew psewdoeksfoljattiva.
Caution is recommended when using DuoTrav in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
Hija rakkomandata attenzjoni meta DuoTrav jintuża f’ pazjenti afakiċi, pazjenti psewdoafakiċi bil - kapsola tal- lenti posterjuri jew lentijiet tal- kompartiment anterjuri mqatta, jew f’ pazjenti b’ fattur ta ’ riskju magħruf għall- edima ċistojda makulari.
In patients with known predisposing risk factors for iritis/ uveitis, DuoTrav can be used with caution.
DuoTrav jista ’ jintuża b’ attenzjoni f’ pazjenti b’ fatturi ta ’ riskju magħrufa li jippredisponewhom għal irite/ uveite.
DuoTrav contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses.
DuoTrav fih benzalkonium chloride li jista ’ jikkawża rritazzjoni u huwa magħruf li jista jbiddel il - kulur ta ’ lentijiet tal- kuntatt rotob.
Contact with soft contact lenses is to be avoided.
Kuntatt ma ’ lentijiet tal- kuntatt rotob għandu jiġi evitat.
Patients must be instructed to remove contact lenses prior to application of DuoTrav and wait 15 minutes after instillation of the dose before reinsertion.
Il- pazjenti għandhom jiġu rakkomandati biex ineħħu il- lentijiet tal- kuntatt qabel l- applikazzjoni ta ’ DuoTrav u għandhom jistennew 15- il minuta wara l- applikazzjoni qabel ma jerġgħu jilbsu l- lentijiet tal- kuntatt.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Benzalkonium chloride, li jintuża b’ mod komuni bħala preservattiv fi prodotti għall- għajnejn, kien irrapportat li jikkawża keratopatija bil- ponot u/ jew keratopatija ulċerattiva tossika.
Since DuoTrav contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Peress li DuoTrav fih benzalkonium chloride, hija meħtieġa sorveljanza mill- viċin jekk jintuża b’ mod frekwenti jew fit - tul.
DuoTrav contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
DuoTrav fih polyoxyethylene hydrogenated castor oil 40 li jista jikkawża reazzjonijiet fil- ġilda.
4.5 Interaction with other medicinal products and other forms of interaction
4 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
There is a potential for additive effects results in hypotension and/ or marked bradycardia when eye drops with timolol are administered concomitantly with oral calcium channel blockers, guanethidine or beta-blocking agents, antiarrhythmics, digitalis glycosides or parasympathomimetics.
Hemm il- potenzjal ta ’ riżultati ta ’ effet miżjud fi pressjoni baxxa u/ jew bradikardja qawwija meta qtar tal- għajnejn li fihom timolol jingħataw fl- istess waqt ma ’ mblokkaturi tal- kanali tal- kalċju, guanethidine jew imblokkaturi tar- riċetturi beta, antiarritmijaċi, digitalis glycosides jew parasimpatomimetiċi.
The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.
Ir- reazzjoni ipertensiva għall- waqfien ħesrem ta ’ clonidine tista ’ tiġi miżjuda meta qed jittieħdu mblokkaturi tar- riċetturi beta.
Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).
Imblokkaturi tar- riċetturi beta jistgħu jaħbu is- sinjali u s- sintomi ta ’ ipogliċemija (ara sezzjoni 4. 4).
Women of childbearing potential/ contraception DuoTrav must not be used in women who may become pregnant unless adequate contraceptive measures are in place (see section 5.3).
Nisa li jista ’ jkollhom it- tfal/ kontraċezzjoni DuoTrav m’ għandux jintuża f’ nisa li jistgħu joħorġu tqal sakemm ma jintużawx meżżi sikuri ta ’ kontraċezzjoni (ara sezzjoni 5. 3).
Pregnancy Travoprost has harmful pharmacological effects on pregnancy and/ or the foetus/ new-born child.
Tqala Travoprost għandu effetti farmakoloġiċi ta ’ ħsara fuq it- tqala u/ jew il- fetu/ tarbija tat- twelid.
Well controlled epidemiological studies with systemic use of beta-blockers did not indicate malformative effects, but some pharmacological effects such as bradycardia have been observed in foetuses or neonates.
Studji epidemjoloġiċi kkontrollati tajjeb bl- użu sistemiku ta ’ mblokkaturi tar- riċetturi beta ma ’ tawx indikazzjoni ta ’ effetti malformattivi, iżda kienu osservati xi effetti farmakoloġiċi bħal bradikardija fil - feti jew fit- trabi tat- twelid.
Data on a limited number of exposed pregnancies indicate no adverse effects of timolol in eye drops on pregnancy or on the health of the foetus/ newborn child but bradycardia and arrhythmia have been reported in one case in the foetus of a woman treated with timolol eye drops.
Tgħarif minn studji dwar numru limitat ta ’ użu waqt it- tqala juri li m’ hemm l- ebda effetti mhux mixtieqa ta ’ timolol qtar għall- għajnejn fuq it- tqala jew fuq is- saħħa tal - fetu/ tarbija tat- twelid, iżda kien irrapportat każ wieħed ta ’ bradikardija u arritmija f’ fetu ta ’ mara kkurata b’ timolol qtar għall- għajnejn.
To date, no other relevant epidemiological data are available.
Sa llum, m’ hemm l- ebda tagħrif epidemjoloġiku ieħor.
DuoTrav should not be used during pregnancy unless clearly necessary.
DuoTrav m’ għandux jintuża waqt it- tqala ħlief meta hemm bżonn speċifiku.
Lactation It is unknown whether travoprost from eye drops is excreted in human breast milk.
Treddigħ Mhux mgħaruf jekk travoprost minn qtar għall- għajnejn jitneħhiex fil- ħalib tas- sider uman.
Animal studies have shown excretion of travoprost and metabolites in breast milk.
Studji fuq il- bhejjem juru eskrezzjoni ta ’ travoprost u l- metaboliti fil- ħalib tas- sider.
Timolol is excreted in breast milk.
Timolol jitneħħa fil- ħalib tas- sider.
However, at therapeutic doses of timolol in eye drops the calculated dose of timolol for the infant would be too low to produce clinical beta-blockade.
Iżda f’ dożi terapewtiċi ta ’ timolol fi qtar għall- għajnejn, id- doża kkalkulata ta ’ timolol għat - tarbija tkun wisq baxxa biex tipproduċi effett kliniku ta ’ mblokk tar- riċetturi beta.
The use of DuoTrav by breast-feeding women is not recommended.
L- użu ta ’ DuoTrav minn nisa li qed irreddgħu mhux rakkomandat.
As with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
Bħal b’ kull qtar għall- għajnejn, vista temporanjament imċajpra jew disturbi oħra fil- vista jistgħu jaffetwaw il- ħila biex issuq jew tħaddem magni.
If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Jekk ma ’ l- applikazzjoni jkun hemm vista mċajpra, il - pazjent għandu jistenna sakemm il- vista tiċċara qabel isuq jew iħaddem magni.
In clinical studies involving 721 patients, DuoTrav was administered once-daily.
Fi studji kliniċi fuq 721 pazjent, DuoTrav kien mogħti darba kuljum.
No serious ophthalmic or systemic undesirable effects related to DuoTrav were reported.
Ma kienu rrapportati l- ebda effetti mhux mixtieq serji, sistemiċi jew fl- għajnejn.
The most frequently reported treatment-related undesirable effect was ocular hyperaemia (15.0%).
L- effett mhux mixtieq, relatat mal- kura, rrapportat l- aktar frekwenti kien iperimija ta ’ l- għajnejn (15. 0%).
Almost all patients (98%) who experienced ocular hyperaemia did not discontinue therapy as a result of this event.
Kważi il- pazjenti kollha (98%) li kellhom esperjenza ta ’ iperimija ta ’ l- għajnejn ma waqfux it- terapija bħala riżultat ta ’ dan l - avveniment.
5 System Organ Class Cardiac disorders
5 Ir- reazzjonijiet avversi elenkati fit- tabella taħt li ġejjin kienu osservati fl- istudji kliniċi jew b’ esperjenza ta ’ wara t- tqegħid fis- suq.
Preferred Term heart rate irregular, heart rate decreased arrhythmia cardiac failure, tachycardia
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Nervous system disorders
Sistema tal- klassifika tal- organi Frekwenza Disturbi fil- qalb Komuni
dizziness, headache cerebrovascular accident, syncope, paraesthesia
Terminu ppreferut rata ta ’ taħbit tal- qalb irregolari, rata ta ’ taħbit tal - qalb imnaqqsa
Eye disorders
Mhux komuni Mhux magħruf Disturbi fis- sistema nervuża Komuni Mhux magħruf Disturbi fl- għajnejn Komuni ħafna Komuni
eye irritation, ocular hyperaemia punctate keratitis, anterior chamber cell, anterior chamber flare, eye pain, photophobia, eye swelling, conjunctival haemorrhage, corneal staining, ocular discomfort, abnormal sensation in eye, visual acuity reduced, visual disturbance, vision blurred, dry eye, eye pruritus, conjunctivitis allergic, lacrimation increased, eyelid irritation, erythema of eyelid, blepharitis, asthenopia, growth of eyelashes
arritmija insuffiċjenza kardijaka, takikardija sturdament, uġigħ ta ’ ras inċident ċerebrovaskulari, sinkope, parasteżija irritazzjoni ta ’ l- għajn, iperimija ta ’ l- għajn keratite bil- ponot, ċelluli fil- kompartiment anterjuri, riflessjoni ta ’ dawl fil- kompartiment anterjuri, uġigħ fl- għajn, fotofobija, nefħa fl- għajn, emorraġija fil- konġuntiva, tebgħa fil- korneja, skomdu fl- għajn, sensazzjoni mhux normali fl - għajn, akutezza tal- vista mnaqqsa, disturbi fil- vista, vista mċajpra, għajn tinħass xotta, ħakk fl- għajn, konġuntivite allerġika, żjieda fid- dmugħ, irritazzjoni tal- kappell ta ’ l- għajn, eritema tal - kappell ta ’ l- għajn, blefarite, astenopija, tkabbir tax- xagħar ta ’ l- għajnejn
corneal erosion, keratitis, eyelid pain, eye allergy, conjunctival oedema, eyelid oedema, eyelids pruritus
taħfir tal- korneja, keratite, uġigħ fil- kappell tal - għajn, allerġija fl- għajn, edima fil- konġuntiva, edima fil- kappell ta ’ l- għajn, ħakk fil- kappell ta ’ l - għajn
Not known
Mhux magħruf
macular oedema, iritis, conjunctivitis, eyelid ptosis, corneal disorder
edima makulari, infjammazzjoni tal- ħabba tal - għajn, konġutivite, ptosi tal- kappell ta ’ l- għajn, disturb fil- korneja
Respiratory, thoracic and mediastinal disorders
Disturbi respiratorji, toraċiċi u Komuni medjastinali Mhux komuni
bronchospasm dyspnoea, cough, throat irritation, postnasal drip asthma
spażmu fil- bronki qtugħ ta ’ nifs, sogħla, irritazzjoni fil- griżmejn, taqtir minn wara l- imnieħer
Renal and urinary disorders Skin and subcutaneous tissue disorders
Mhux magħruf Disturbi fil- kliewi u fis- sistema Mhux komuni urinarja
Uncommon Common Uncommon Not known
ażżma kromaturja
Musculoskeletal and connective tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ Komuni taħt il- ġilda Mhux komuni Mhux magħruf Disturbi muskolu- skeltrali u tal - Komuni connective tissue
Vascular disorders General disorders and administration site conditions
urtikarja, iperpigmentazzjoni tal- ġilda (madwar l - għajnejn) dermatite tal- kuntatt raxx, alopeċja uġigħ fl- estremitajiet
Common Uncommon Not known
Disturbi vaskulari Komuni
blood pressure increased, blood pressure decreased thirst chest pain
żjieda fil- pressjoni tad- demm, tnaqqis fil- pressjoni tad- demm
Hepatobiliary disorders
Disturbi ġenerali u kondizzjonijiet Mhux komuni ta 'mnejn jingħata Mhux magħruf Disturbi fil- fwied u fil- marrara Mhux komuni
alanine aminotransferase increased, aspartate aminotransferase increased
għatx uġigħ fis- sider żjieda fl- alanine aminotransferase, żjieda fl - aspartate aminotransferase
Psychiatric disorders
Disturbi psikjatriċi Komuni Mhux magħruf
Common Not known
nervi depressjoni
Additional adverse events that have been seen with one of the components and may potentially occur with DuoTrav:
Avvenimenti avversi oħra li kienu osservati b’ wieħed mill- komponenti u li potenzjalment jistgħu jseħħu b’ DuoTrav:
Eye disorders: uveitis, conjunctival disorder, conjunctival follicles, eyelid margin crusting, iris hyperpigmentation
uveite, disturb fil- konġuntiva, follikuli fil- konġuntiva, qoxra fit- tarf tal - kappell ta ’ l- għajn, iperpigmentazzjoni tal- ħabba tal- għajn
Skin and subcutaneous tissue disorders: skin exfoliation
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda: tqaxxir tal- ġilda
Cardiac disorders: cardiac arrest, atrioventricular block, palpitations
Disturbi fil- qalb: attakk tal- qalb, blokk atrioventrikulari, palpitazzjonijiet
cerebral ischaemia, myasthenia gravis,
iskemija ċerebrali, mijastenija gravis
Eye disorders: diplopia
Disturbi fl- għajnejn: diplopja
Respiratory, thoracic and mediastinal disorders: respiratory failure, nasal congestion
Disturbi respiratorji, toraċiċi u medjastinali: insuffiċjenza respiratorja, konġestjoni fl- imnieħer
Gastrointestinal disorders: diarrhoea, nausea
Disturbi gastro- intestinali: dijarea, tqalligħ
Metabolism and nutrition disorders: hypoglycaemia
Disturbi fil- metaboliżmu u n- nutrizzjoni: ipogliċemija
General disorders and administration site conditions: asthenia
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: astenja
4.9 Overdose
4. 9 Doza eċċessiva
If overdose with DuoTrav occurs, treatment should be symptomatic.
Jekk ikun hemm doża eċċessiva b’ DuoTrav, il- kura għandha tkun sintomatika.
Timolol does not dialyse readily.
Timolol ma jitneħħiex faċilment bid- dijalisi.
Ophthalmologicals-antiglaucoma preparations and miotics-beta-blocking agents-timolol, combinations.
Preparazzjonijiet oftalmoloġiċi- antiglawkoma u miotics- imblokkaturi tar- riċetturi beta- timolol, taħlitiet.
S01ED51
S01E E04
Mechanism of action DuoTrav contains two active substances: travoprost and timolol maleate.
Mekkaniżmu ta ’ azzjoni DuoTrav fih żewġ sustanzi attivi: travoprost u timolol maleate.
These two components lower intraocular pressure by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound alone.
Dawn iż- żewġ komponenti jbaxxu l - pressjoni ġewwa l- għajn b’ mekkaniżmi ta ’ azzjoni li jikkumplimentaw lil xulxin u l- effett kombinat jirriżulta f’ aktar tnaqqis tal- pressjoni ġewwa l- għajn (IOP) meta mqabbel mal- azzjoni ta ’ kull komponent waħdu.
Travoprost, a prostaglandin F2α analogue, is a full agonist which is highly selective and 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 min ġewwa ix- xibka trabekulari u r- rotot uveosklerali.
Reduction of IOP in man starts within approximately 2 hours after administration and maximum effect is reached after 12 hours.
Fil- bniedem, tnaqqis tal- IOP 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 sustanzjali fil- pressjoni tal- għajn jista ’ jiġi miżmum għall- perijodu ta ’ aktar minn 24 siegħa b’ doża waħda.
Timolol is a non-selective adrenergic blocking agent that has no intrinsic sympathomimetic, direct myocardial depressant or membrane-stabilising activity.
Timolol huwa mblokkatur adrinerġiku mhux selettiv li m’ għandux attività simpatomimetika intrinsika, attività ta ’ depressjoni mijokardijaka diretta jew attività ta ’ stabilizzazzjoni tal- membrana.