natgillin/translations-raw huggingface dataset:
One of the three trials also included a comparison with latanoprost (another prostaglandin analogue used for glaucoma).
V eni od treh raziskav so zdravilo primerjali tudi z zdravilno učinkovino latanoprost (še en analog prostaglandina, ki se uporablja pri zdravljenju glavkoma).
The main measure of effectiveness was the reduction in intraocular eye pressure (IOP).
Glavno merilo učinkovitosti je bilo znižanje očesnega tlaka.
Another study also compared the effectiveness of adding TRAVATAN to treat patients who were also receiving timolol (427 patients, 6-month duration).
V drugi raziskavi so primerjali tudi učinkovitost dodajanja zdravila TRAVATAN bolnikom, ki so sočasno prejemali tudi timolol (427 bolnikov v času 6 mesecev).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has TRAVATAN shown during the studies?
Kakšne koristi je zdravilo TRAVATAN izkazalo med raziskavami?
TRAVATAN was at least as effective as timolol and as effective as latanoprost in reducing intraocular pressure.
Zdravilo TRAVATAN je bilo pri nižanju očesnega tlaka vsaj tako učinkovito kot timolol in enako učinkovito kot latanoprost.
The combined treatment with TRAVATAN plus timolol produced an additional decrease of IOP in patients who were not controlled with timolol alone.
Kombinirano zdravljenje z zdraviloma TRAVATAN in timolol je imelo za posledico večji padec očesnega tlaka kot pri bolnikih, ki so prejemali samo timolol.
What is the risk associated with TRAVATAN?
Kakšna tveganja so povezana z zdravilom TRAVATAN?
The most common side effects when using TRAVATAN (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to eye irritation and redness) and eyelash changes, including increased length, thickness, colour or number of lashes.
Najpogostejši neželeni učinki pri uporabi zdravila TRAVATAN (opaženi pri več kot 1 bolniku od 10) so očesna hiperemija (povečan dotok krvi v oko, ki pripelje do draženja in rdečice očesa), spremembe trepalnic, ki vključujejo povečano dolžino, debelino, barvo ali število trepalnic.
For the full list of all side effects reported with TRAVATAN, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila TRAVATAN, glejte Navodilo za uporabo.
TRAVATAN should not be used in people who may be hypersensitive (allergic) to travoprost or any of the other ingredients.
Zdravila TRAVATAN ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) travoprost ali katerokoli drugo sestavino zdravila.
TRAVATAN contains benzalkonium chloride, which is known to discolour soft contact lenses.
Zdravilo TRAVATAN vsebuje benzalkonijev klorid, katerega znana lastnost je, da razbarva mehke kontaktne leče.
Why has TRAVATAN been approved?
Zakaj je bilo zdravilo TRAVATAN odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that TRAVATAN’ s benefits are greater than its risks for the treatment of elevated intraocular pressure in open angle glaucoma or ocular hypertension.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so za zdravljenje povišanega očesnega tlaka pri glavkomu z odprtim zakotjem in očesni hipertenziji koristi zdravila TRAVATAN večje od z njim povezanih tveganj.
They recommended that TRAVATAN be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom TRAVATAN.
Other information about TRAVATAN:
Druge informacije o zdravilu TRAVATAN:
The European Commission granted a marketing authorisation valid throughout the European Union, for TRAVATAN to Alcon Laboratories (UK) Limited on 27 November 2001.
Evropska komisija je dovoljenje za promet z zdravilom TRAVATAN, veljavno po vsej Evropski uniji, odobrila družbi Alcon Laboratories (UK) Limited dne 27. novembra 2001.
The marketing authorisation was renewed on 27 November 2006.
Dovoljenje za promet je bilo podaljšano dne 27. novembra 2006.
The full EPAR for TRAVATAN is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo TRAVATAN je na voljo tukaj.
Bottle (polypropylene)
steklenička (polipropilen)
2.5 ml (40 µg/ ml)
2. 5 ml
EU/ 1/ 01/ 199/ 002 Travatan
EU/ 1/ 01/ 199/ 002
TRAVATAN 40 micrograms/ ml eye drops, solution
TRAVATAN 40 mikrogramov/ ml kapljice za oko, raztopina
1 ml of solution contains 40 micrograms of travoprost.
1 ml raztopine vsebuje 40 mikrogramov travoprosta.
Excipients: benzalkonium chloride 0.15 mg, polyoxyethylene hydrogenated castor oil 40 (HCO-40) 5 mg (see section 4.4.)
Pomožne snovi: benzalkonijev klorid 0, 15 mg, makrogolglicerol hidroksistearat 5 mg (glejte poglavje 4. 4)
Decrease of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma (see section 5.1).
Znižanje zvišanega očesnega tlaka pri bolnikih z očesno hipertenzijo ali glavkomom z odprtim zakotjem (glejte poglavje 5. 1).
For ocular use.
Za okularno uporabo
Use in adults, including the elderly The dose is one drop of TRAVATAN in the conjunctival sac of the affected eye(s) once daily.
Uporaba pri odraslih, vključno s starostniki Odmerek je ena kapljica zdravila TRAVATAN v veznično vrečko prizadetega očesa (oči) enkrat na dan.
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).
Če bolnik sočasno uporablja več topikalnih očesnih zdravil, naj jih uporabi z razmikom najmanj 5 minut (glejte poglavje 4. 5).
When substituting another ophthalmic antiglaucoma agent with TRAVATAN, the other agent should be discontinued and TRAVATAN should be started the following day.
Pri prehodu z drugega očesnega zdravila proti glavkomu na zdravilo TRAVATAN naj bolnik preneha jemati prvo zdravilo in začne uporabljati TRAVATAN naslednji dan.
Paediatric patients The efficacy and safety of TRAVATAN 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.
Pediatrični bolniki Učinkovitosti in varnosti zdravila TRAVATAN pri bolnikih, mlajših od 18 let, še niso ugotovili, zato pri njih ne priporočamo uporabe zdravila, dokler ne bodo na voljo dodatni podatki.
2 Use in hepatic and renal impairment TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/ min).
Uporaba pri bolnikih z jetrno ali ledvično okvaro TRAVATAN so raziskovali pri bolnikih z blago do hudo jetrno okvaro in pri tistih z blago do hudo ledvično okvaro (očistek kreatinina le 14 ml/ min).
The patient should remove the protective overwrap immediately prior to initial use.
2 Bolnik naj odstrani zaščitni omot tik pred prvo uporabo.
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.
Da prepreči kontaminacijo vrha kapalnega dela plastenke in raztopine, mora paziti, da se pri vkapanju zdravila s kapalnim delom plastenke ne dotakne vek, kože v bližini ali drugih površin.
TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes.
TRAVATAN lahko postopoma spremeni barvo oči, saj poveča število melanosomov (pigmentnih zrnc) v melanocitih.
Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour.
Pred začetkom zdravljenja morate bolnika opozoriti na možnost stalne spremembe barve oči.
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.
Spremembo barve oči so ugotavljali predvsem pri bolnikih z večbarvno šarenico, npr. modro- rjavo, sivo- rjavo, rumeno- rjavo in zeleno- rjavo, opažali pa so jo tudi pri bolnikih z rjavimi očmi.
Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish.
Rjava barva okoli zenice se v prizadetem očesu običajno koncentrično razširi proti periferiji, vendar lahko porjavi šarenica v celoti ali delno.
In controlled clinical trials, periorbital and/ or eyelid skin darkening in association with the use of TRAVATAN has been reported in 0.4% of patients.
V kontroliranih kliničnih preskušanjih so pri 0, 4% bolnikov poročali o potemnitvi kože okoli očesa, potemnitvi kože vek ali obojega ob uporabi zdravila TRAVATAN.
TRAVATAN 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.
Pri približno eni polovici bolnikov v kliničnih preskušanjih so ugotavljali naslednje spremembe: podaljšanje, odebelitev, potemnitev in/ ali povečanje števila trepalnic.
There is no experience of TRAVATAN 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.
Izkušnje z uporabo tega zdravila pri prizadetosti oči pri boleznih ščitnice, glavkomu z odprtim zakotjem pri psevdofakičnih bolnikih ter pri pigmentnem ali psevdoeksfoliativnem glavkomu pa so omejene.
Skin contact with TRAVATAN must be avoided as transdermal absorption of travoprost has been demonstrated in rabbits.
Bolnik se mora izogibati stiku kože z zdravilom TRAVATAN, saj so pri kuncih pokazali, da se travoprost absorbira transdermalno.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Poročali so, da benzalkonijev klorid, ki se pogosto uporablja kot konzervans v očesnih zdravilih, povzroči pikčasto keratopatijo in/ ali toksično ulcerozno keratopatijo.
Since TRAVATAN contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Ker TRAVATAN vsebuje benzalkonijev klorid, je pri pogosti ali daljši uporabi tega zdravila potrebno skrbno spremljanje bolnika.
In patients with known predisposing risk factors for iritis/ uveitis, TRAVATAN can be used with caution.
Pri bolnikih z znanimi predispozicijskimi dejavniki tveganja za nastanek iritisa ali uveitisa lahko previdno uporabljate zdravilo TRAVATAN.
3 Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin.
Prostaglandini in analogi prostaglandinov so biološko aktivne snovi, ki se lahko absorbirajo skozi kožo.
Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle.
Nosečnice ali ženske, ki skušajo zanositi, morajo uporabljati ustrezne previdnostne ukrepe, da preprečijo neposreden stik z vsebino plastenke.
In the unlikely event of coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the exposed area immediately
V malo verjetnem primeru stika z večjim delom vsebine plastenke je treba nemudoma temeljito očistiti izpostavljeni predel.
Contact with soft contact lenses is to be avoided.
3 TRAVATAN vsebuje benzalkonijev klorid, ki lahko povzroči draženje in je zanj znano, da spremeni barvo mehkih kontaktnih leč, zato se je treba izogibati stiku zdravila z mehkimi kontaktnimi lečami.
TRAVATAN contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
TRAVATAN vsebuje makrogolglicerol hidroksistearat, ki lahko povzroči kožne reakcije.
Women of child-bearing potential/ contraception TRAVATAN must not be used in women of child bearing age/ potential unless adequate contraceptive measures are in place (see section 5.3).
Ženske v rodni dobi/ kontracepcija Zdravila TRAVATAN ne smejo uporabljati ženske v rodni dobi, ki bi lahko zanosile, če nimajo ustrezne kontracepcijske zaščite (glejte poglavje 5. 3).
Pregnancy Travoprost has harmful pharmacological effects on pregnancy and/ or the foetus/ new-born child.
Nosečnost Travoprost ima škodljive farmakološke učinke na nosečnost in/ ali plod oziroma novorojenega otroka.
TRAVATAN should not be used during pregnancy unless clearly necessary.
Zdravila TRAVATAN ne smete uporabljati v času nosečnosti, če to ni nujno.
The use of TRAVATAN by breast- feeding mothers is not recommended.
Študije na živalih so pokazale, da se travoprost in njegovi presnovki izločajo v materino mleko, zato uporaba zdravila TRAVATAN pri doječih materah ni priporočljiva.
In clinical studies involving over 4200 patients, TRAVATAN was administered once daily as monotherapy or adjunctive therapy to timolol 0.5%.
V kliničnih študijah na več kot 4200 bolnikih so zdravilo TRAVATAN uporabljali enkrat na dan v monoterapiji ali kot adjuvantno terapijo ob 0, 5% timololu.
No serious ophthalmic or systemic undesirable effects related to TRAVATAN were reported in any of the clinical studies.
V nobeni od kliničnih študij niso poročali o resnejših očesnih ali sistemskih neželenih učinkih v zvezi z zdravilom TRAVATAN.
The most frequently reported treatment-related undesirable effect with TRAVATAN monotherapy was hyperaemia of the eye (22.3%), which included ocular, conjunctival, or scleral hyperaemia.
Najpogosteje opisan z zdravljenjem povezan neželeni učinek pri monoterapiji z zdravilom TRAVATAN je bila očesna hiperemija (22, 3%), ki je vključevala hiperemijo očesa, hiperemijo veznice ali hiperemijo beločnice.
Hyperaemia was mild in 83.0% of those patients who experienced it.
Pri 83, 0% bolnikov, ki so imeli ta neželeni učinek, je bila hiperemija blaga.
Almost all patients (98%) who experienced hyperaemia did not discontinue therapy as a result of this event.
Pri skoraj vseh bolnikih (98%), ki so imeli hiperemijo, jim zaradi tega učinka ni bilo treba prekiniti terapije.
In phase III clinical studies ranging from 6 to 12 months in duration, hyperaemia decreased over time.
V kliničnih študijah tretje faze, ki so trajale od 6 do 12 mesecev, se je hiperemija zmanjševala s časom.
The following undesirable effects were assessed to be treatment-related (with TRAVATAN monotherapy) and are classified according to the following convention: very common (≥ 1/ 10), common (> 1/ 100 to< 1/10), uncommon (> 1/1,000 to ≤ 1/100), rare (> 1/10,000 to ≤1/1000), or very rare (≤1/10,000).
Naslednji neželeni učinki so bili ocenjeni kot povezani z zdravljenjem (z zdravilom TRAVATAN v monoterapiji) in so jih razvrstili v skladu z naslednjim dogovorom: zelo pogosti (≥1/ 10), pogosti (> 1/ 100 do < 1/ 10), občasni (> 1/ 1. 000 do ≤1/ 100), redki (> 1/ 10. 000 do ≤1/ 1. 000) ali zelo redki (≤1/ 10. 000).
4 Infections and infestations:
Infekcijske in parazitske bolezni:
Uncommon: herpes simplex
Občasni: herpes simpleks
Uncommon: hypersensitivity, seasonal allergy
Občasni: preobčutljivost, sezonske alergije
Nervous system disorders:
4 Bolezni živčevja:
Common: headache Uncommon: dysgeusia
Pogosti: glavobol Občasni: disgevzija
Very common: conjunctival hyperaemia, ocular hyperaemia Common: punctate keratitis, anterior chamber cell, anterior chamber flare, eye pain, photophobia, eye discharge, ocular discomfort, eye irritation, abnormal sensation in eye, foreign body sensation in eyes, visual acuity reduced, vision blurred, dry eye, eye pruritus, lacrimation increased, erythaema of eyelid, eyelid oedema, eyelids pruritis, growth of eyelashes, iris hyperpigmentation, eyelash discolouration Uncommon: corneal erosion, iridocyclitis, iritis, uveitis, visual field defect, keratitis, anterior chamber inflammation, eye swelling, corneal staining, photopsia, blepharitis, conjunctival oedema, conjunctivitis allergic, conjunctival disorder, conjunctivitis, conjunctival follicles, hypoaesthesia eye, ectropion, keratoconjunctivitis sicca, madarosis, cataract, eye allergy, eyelid pain, eyelid disorder, eyelid margin crusting, scleral hyperaemia, asthenopia
Zelo pogosti: hiperemija veznice, očesna hiperemija Pogosti: pikčasti keratitis, celice v sprednjem očesnem prekatu, migljanje v sprednjem očesnem prekatu, očesne bolečine, fotofobija, izcedek iz očesa, neprijeten občutek v očesu, draženje očesa, nenormalen občutek v očesu, občutek tujka v očesu, zmanjšana ostrina vida, zamegljen vid, suho oko, očesni pruritus, povečano solzenje, eritem vek, edem vek, pruritus vek, rast trepalnic, hiperpigmentacija šarenice, potemnitev trepalnic Občasni: erozije roženice, iridociklitis, iritis, uveitis, izpad vidnega polja, keratitis, vnetje v sprednjem očesnem prekatu, otekanje očesa, obarvanje roženice, fotopsija, blefaritis, edem veznice, alergijski konjunktivitis, veznične motnje, konjunktivitis, veznični folikli, hipoestezija očesa, ektropij, keratoconjunctivitis sicca, madaroza, katarakta, očesne alergije, bolečine v vekah, motnje vek, kraste na robu vek, hiperemija beločnice, astenopija
Uncommon: heart rate irregular, palpitations, heart rate decreased
Občasni: neredno bitje srca, palpitacije, zmanjšana srčna frekvenca
Uncommon: blood pressure decreased, blood pressure increased, hypotension
Občasni: znižan krvni tlak, zvišan krvni tlak, hipotenzija
Uncommon: dysponea, asthma, respiratory disorder, pharyngolaryngeal pain, cough, dysphonia, nasal congestion, throat irritation
Občasni: dispneja, astma, bolezni dihal, faringolaringealne bolečine, kašelj, disfonija, otekanje nosne sluznice, draženje žrela
Uncommon: peptic ulcer reactivated, gastrointestinal disorder, constipation
Občasni: ponovitev peptičnega ulkusa, prebavne motnje, zaprtje
Common: skin hyperpigmentation (periocular) Uncommon: dermatitis allergic, periorbital oedema, dermatitis contact, erythaema, hair colour changes, hair texture abnormal, hypertrichosis
Pogosti: hiperpigmentacija kože (okoli očesa) Občasni: alergijski dermatitis, periorbitalni edem, kontaktni dermatitis, eritem, sprememba barve las, nenormalna tekstura las, hipertrihoza
Uncommon: shoulder pain
Občasni: bolečine v rami
General disorders and administrative site conditions:
Splošne težave in spremembe na mestu aplikacije:
Uncommon: asthenia, malaise
Občasni: astenija, bolehnost
Adverse reactions identified from post-marketing experience that have not been reported previously in clinical trials with TRAVATAN as monotherapy include the following.
Neželeni učinki, ki so jih ugotovili šele v okviru postmarketinških izkušenj in o njih prvotno niso poročali v kliničnih preskušanjih z zdravilom TRAVATAN v obliki monoterapije, so naslednji:
Ocular: macular oedema (see also section 4.4) Systemic: bradycardia, tachycardia, asthma aggravated, vertigo, tinnitus, PSA increased, hair growth abnormal.
Očesni: edem makule (glejte tudi poglavje 4. 4) Sistemski: bradikardija, tahikardija, poslabšanje astme, vrtoglavica, tinitus, zvišana koncentracija glikoproteina PSA, nenormalna rast las
5 No cases of overdose have been reported.
Ni poročil o primerih prevelikega odmerjanja.
A topical overdose is not likely to occur or to be associated with toxicity.
Verjetnost, da bi prišlo pri topikalni uporabi zdravila do prevelikega odmerjanja oziroma da bo le- ta povezana s toksičnostjo zdravila, je majhna.
Ophthalmologicals – antiglaucoma preparations and miotics – prostaglandin analogues ATC code:
Oznaka ATC:
Mechanism of action Travoprost, a prostaglandin F2α analogue, is a highly selective full agonist which has a high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways.
Očesni tlak zniža tako, da poveča iztekanje prekatne vodke skozi trabekularno omrežje in po uveoskleralnih poteh.
Data on adjunctive administration of TRAVATAN with timolol 0.5% and limited data with brimonidine 0.2% were collected during clinical trials that showed an additive effect of TRAVATAN with these glaucoma medications.
Podatki o adjuvantni uporabi zdravila TRAVATAN z 0, 5% timololom in omejeni podatki o uporabi z 0, 2% brimonidinom so bili zbrani v kliničnih preskušanjih, ki so pokazala aditivno delovanje zdravila TRAVATAN s temi zdravili proti glavkomu.
Secondary pharmacology Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of topical ocular administration (1.4 micrograms, once-daily)
Sekundarna farmakologija Po 7- ih dneh topikalne uporabe na očesu, je travoprost bistveno povečal pretok krvi do glave vidnega živca pri kuncih (1, 4 mikrograme, enkrat na dan).
Absorption Travoprost is an ester prodrug.
Absorpcija Travoprost je estrsko predzdravilo.
Studies in rabbits have shown peak concentrations of 20 ng/ g of the free acid in aqueous humour one to two hours after topical dosing of TRAVATAN.
Študije na kuncih so pokazale največjo koncentracijo proste kisline v prekatni vodki 20 ng/ g eno do dve uri po topikalni uporabi zdravila TRAVATAN.
Aqueous humour concentrations declined with a half-life of approximately 1.5 hours.
Koncentracija zdravila v prekatni vodki se je zmanjševala z razpolovno dobo približno 1, 5 ur.
Distribution Following topical ocular administration of TRAVATAN to healthy volunteers, low systemic exposure to active free acid was demonstrated.
Porazdelitev Po topikalni okularni uporabi zdravila TRAVATAN pri zdravih prostovoljcih so ugotovili majhno sistemsko izpostavljenost aktivni prosti kislini.
Peak active free acid plasma concentrations of 25 pg/ ml or less were observed between 10 and 30 minutes post-dose.
Od 10 do 30 minut po odmerku je bila najvišja plazemska koncentracija aktivne proste kisline 25 pg/ ml ali manj.
Thereafter, plasma levels declined rapidly to below the 10 pg/ ml assay quantitation limit before 1 hour post-administration.
Potem je plazemska koncentracija hitro padla pod mejo kvantifikacije 10 pg/ ml, še preden je potekla 1 ura po uporabi zdravila.
Metabolism Metabolism is the major route of elimination of both travoprost and the active free acid.
Presnova Glavna pot izločanja tako travoprosta kot aktivne proste kisline je presnova.
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.
Sistemske presnovne poti so podobne tistim za endogeni prostaglandin F2α, za katerega so značilni redukcija dvojne vezi 13- 14, oksidacija 15- hidroksila in β- oksidativni razcep zgornje stranske verige.
TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/ min).
Izločanje Prosta kislina travoprosta in njegovi presnovki se izločajo predvsem skozi ledvice. Zdravilo TRAVATAN so raziskovali pri bolnikih z blago do hudo jetrno okvaro in pri bolnikih z blago do hudo ledvično okvaro (očistek kreatinina le 14 ml/ min).
In ocular toxicity studies in monkeys, administration of travoprost at a dose of 0.45 microgram, twice a day, was shown to induce increased palpebral fissure.
Študije očesne toksičnosti zdravila pri opicah so pokazale, da dajanje travoprosta v odmerku 0, 45 mikrogramov dvakrat na dan pogosteje povzroči nastanek palpebralne fisure.
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.
Topikalna okularna uporaba travoprosta na desnem očesu pri opicah, v koncentracijah do 0, 012% dvakrat na dan, v času enega leta, ni povzročila nikakršnih sistemskih toksičnih učinkov.
Reproduction toxicity studies have been undertaken in rat, mice and rabbit by systemic route.
6 Študije vpliva na sposobnost razmnoževanja so opravili s sistemsko uporabo zdravila na podganah, miših in kuncih.