natgillin/translations-raw huggingface dataset:
Plasma protein binding of atosiban is 46 to 48% in pregnant women.
13 Vezava atosibana na beljakovine v plazmi je pri nosečnicah od 46 do 48%.
Following an infusion of 300 micrograms/ min in healthy pregnant women at term, the fetal/ maternal atosiban concentration ratio was 0.12.
Po infuziji 300 mikrogramov/ min zdravim nosečnicam ob roku je bilo razmerje med koncentracijo atosibana pri plodu in materi 0, 12.
The ratios of the main metabolite M1 (des-(Orn8, Gly-NH29)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) to atosiban concentrations 13 in plasma were 1.4 and 2.8 at the second hour and at the end of the infusion respectively.
Razmerje med koncentracijo glavnega presnovka M1 (des - (Orn8, Gly- NH29) - [Mpa1, D- Tyr( Et) 2, Thr4] - oksitocin) in atosibana v plazmi je bilo po dveh urah 1, 4 in na koncu infundiranja 2, 8.
Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Atosiban se v urinu pojavi le v majhni količini; njegova koncentracija v urinu je približno 50- krat manjša od koncentracije M1.
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys (see sections 4.2 and 4.4).
Izkušenj z uporabo atosibana pri bolnicah z okvarjenim delovanjem jeter ali ledvic ni (glejte poglavji 4. 2 in 4. 4).
Reproduction toxicity studies, with dosing from implantation up to late stage pregnancy, showed no effects on mothers and fetuses.
Raziskave reprodukcijske toksičnosti, z uporabo zdravila od oploditva do pozne nosečnosti, niso pokazale nobenih učinkov na matere in zarodke.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Ker raziskav kompatibilnosti ni, tega zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedena pod 6. 6.
Once the vial has been opened, the dilution must be performed immediately.
Ko je viala odprta, je treba zdravilo takoj razredčiti.
Store in a refrigerator (2°C - 8°C).
14 Shranjujte v hladilniku (2 °C – 8 °C).
One vial of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban.
Ena viala koncentrata za pripravo raztopine za infundiranje vsebuje 5 ml raztopine, kar ustreza 37, 5 mg atosibana.
14 Colourless glass vials, clear borosilicated (type I) sealed with grey siliconised bromo-butyl rubber stopper, type I, and flip-off cap of polypropylene and aluminium.
Viala iz brezbarvnega, prozornega borosilikatnega stekla (tipa I), zaprta s sivim, silikoniziranim brombutilnim gumijastim zamaškom z odtržno zaporko iz polipropilena in aluminija.
For intravenous infusion, following the bolus dose, TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion should be diluted in one of the following solutions: − 0.9% w/ v NaCl − Ringer's lactate solution − 5% w/ v glucose solution.
Za pripravo intravenske infuzije, ki sledi bolusnemu odmerku, je treba koncentrat za pripravo raztopine za infundiranje TRACTOCILE 7. 5 mg/ ml razredčiti z eno od naslednjih raztopin: − 0, 9% (ut/ vol) raztopino NaCl, − raztopino Ringerjevega laktata, − 5% (ut/ vol) raztopino glukoze.
Replace it by 10 ml TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Nadomestite jo z 10 ml zdravila TRACTOCILE 7, 5 mg/ ml, koncentrat za pripravo raztopine za infundiranje, ki jih dobite iz dveh 5 ml vial, tako da bo končna koncentracija 75 mg atosibana v 100 ml.
The reconstituted product is a clear, colourless solution without particles.
Končni produkt je bistra, brezbarvna raztopina brez delcev.
The loading infusion is given by infusing 24 ml/ hour (i. e.
Polnilna infuzija se aplicira z infundiranjem tako pripravljene raztopine s hitrostjo 24 ml/ uro (tj.
18 mg/ h) of the above prepared solution over the 3 hour period under adequate medical supervision in an obstetric unit.
18 mg/ uro) v 3 urah pod ustreznim zdravniškim nadzorstvom na porodnem oddelku.
After three hours the infusion rate is reduced to 8 ml/ hour.
Po 3 urah je treba hitrost infundiranja zmanjšati na 8 ml/ uro.
If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Če uporabite infuzijsko vrečko z drugačno količino, je treba potrebni odmerek ustrezno preračunati.
To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/ min.
Za natančno odmerjanje je priporočljivo uporabiti pripomoček za kontrolirano infundiranje, tako da je hitrost mogoče prilagajati v kapljicah na minuto.
An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for TRACTOCILE.
Intravenska mikrokapalna komora lahko zagotavlja ustrezen razpon hitrosti infundiranja v priporočenih odmernih mejah za TRACTOCILE.
If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used.
Če je hkrati treba intravensko dati druga zdravila, je mogoče uporabiti isto intravensko kanilo ali pa intravensko aplikacijo opraviti na drugem mestu.
EU/ 1/ 99/ 124/ 002
15 EU/ 1/ 99/ 124/ 002
FERRING AB Soldattorpsvägen 5 SE-20061 Limhamn Sweden
FERRING AB Soldattorpsvägen 5 SE- 20061 Limhamn Sweden
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUHORISATION HOLDER
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Medicinal product subject to restricted medical prescription (See Annex I:
(Glej Dodatek I:
Summary of Product Characteristics, 4.2).
Povzetek glavnih značilnosti zdravila 4. 2)
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING.
PRIMARNI, KADAR ZUNANJE NI
TRACTOCILE 7.5 mg/ ml solution for injection atosiban
TRACTOCILE 7, 5 mg/ ml raztopina za injiciranje atosiban
Each vial contains 6.75 mg of atosiban
Ena viala vsebuje 6, 75 mg atosibana.
1 ml of solution contains:
1 ml raztopine vsebuje:
Mannitol 50 mg Hydrocloric acid 1M to pH 4.5 Water for injections to 1 ml
manitol 50 mg klorovodikova kislina 1 M do pH 4, 5 voda za injekcije do 1 ml
Solution for injection One vial of 0.9 ml contains 6.75 mg of atosiban
Ena 0, 9 ml viala vsebuje 6, 75 mg atosibana.
EXPIRY DATE
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVLA
Store in a refrigerator Store in the original package Once the vial has been opened, the solution must be used immediately
Ko je viala odprta, je treba raztopino uporabiti takoj.
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MAJŠIH STIČNIH OVOJNINAH
Vial
VIALA
METHOD OF ADMINISTRATION
POSTOPEK IN POT( I) UPORABE ZDRAVILA
6.75 mg in 0.9 ml
6. 75 mg v 0. 9 ml
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING.
PRIMARNI, KADAR ZUNANJE NI
TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion atosiban
TRACTOCILE 7, 5 mg/ ml koncentrat za pripravo raztopine za in infundiranje atosiban
Each vial contains 37.5 mg of atosiban
Ena viala vsebuje 37, 5 mg atosibana.
Concentrate for solution for infusion One vial of 5 ml contains 37.5 mg of atosiban Provides 0.75 mg/ ml when diluted as recommended
Po priporočenem razredčenju da 0, 75 mg/ ml.
Store in a refrigerator Store in the original package The diluted solution must be used within 24 hours
Razredčeno raztopino je treba uporabiti v 24- ih urah.
Dilute before use Read the package leaflet before use
Pred uporabo preberite navodilo.
25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
25 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MAJŠIH STIČNIH OVOJNINAH
TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion
TRACTOCILE 7, 5 mg/ ml koncentrat za pripravo raztopine za in infundiranje
37.5 mg in 5 ml
37, 5 mg v 5 ml
27 PACKAGE LEAFLET
27 NAVODILO ZA UPORABO
- This leaflet contains practical information on TRACTOCILE.
- Navodilo vsebuje pomembne informacije o TRACTOCILU.
- If you have further questions, please ask your doctor, midwife or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
- TRACTOCILE is a medicinal product to be used in hospital and should only be administered
- TRACTOCILE je zdravilo, ki se uporablja v bolnišnici in se sme dajati le pod nadzorstvom
under supervision of experienced hospital personnel.
izkušenega bolniškega osebja.
What TRACTOCILE is and what it is used for 2.
Kaj je TRACTOCILE in za kaj ga uporabljamo 2.
Before you use TRACTOCILE 3.
Kaj morate vedeti, preden boste uporabili TRACTOCILE 3.
How to use TRACTOCILE 4.
Kako uporabljati TRACTOCILE 4.
Storing TRACTOCILE 6.
Shranjevanje TRACTOCILE 6.
TRACTOCILE 7.5 mg/ ml, solution for injection atosiban
TRACTOCILE 7, 5 mg/ ml, raztopina za injiciranje Atosiban
Marketing Authorisation Holder Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 2300 København S Denmark
Imetnik dovoljenja za promet zdravilom Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 2300 København S Danska
Manufacturer Ferring AB Soldattorpsvägen 5 Box 30047 SE - 20061 Limhamn Sweden
Izdelovalec Ferring AB Soldattorpsvägen 5 Box 30047 SE - 20061 Limhamn Švedska
Ferring GmbH Wittland 11 24109 Kiel Germany
Ferring GmbH Wittland 11 24109 Kiel Nemčija
WHAT TRACTOCILE IS AND WHAT IT IS USED FOR
KAJ JE TRACTOCILE IN ZA KAJ GA UPORABLJAMO
Each vial of TRACTOCILE 7.5 mg/ ml, solution for injection, contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
Ena viala TRACTOCILA 7, 5 mg/ ml, raztopine za injiciranje, vsebuje atosibanijev acetat, kolikor ustreza 6, 75 mg atosibana v 0, 9 ml.
Atosiban blocks the ability of the natural hormone oxytocin to cause the uterus (womb) to contract.
Atosiban zavira sposobnost naravnega hormona oksitocina za sprožitev krčenja maternice.
TRACTOCILE can be used to decrease the frequency and intensity of uterine contractions in pregnant women in order to delay a premature birth.
TRACTOCILE je mogoče uporabiti za zmanjšanje pogostnosti in moči popadkov pri nosečnicah, da bi preprečili prezgoden porod.
BEFORE YOU USE TRACTOCILE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI TRACTOCILE
Do not use TRACTOCILE:
Ne uporabljajte TRACTOCILA:
- if your pregnancy is less than 24 weeks or more than 33 weeks
- če ste noseči manj kot 24 ali več kot 33 tednov,
- if you have premature rupture of the membranes after 30 weeks of pregnancy
- če imate prezgodnje pretrganje plodovnih ovojnic po 30. tednu nosečnosti,
- if the fetus is growing insufficiently and has an abnormal fetal heart rate
- če doživljate krvavitev iz maternice, ki zahteva takojšen porod,
- if you experience uterine bleeding that requires immediate delivery
- če imate hudo predeklampsijo (visok krvni tlak, zastajanje tekočine in/ ali beljakovine v urinu)
- if you have severe pre-eclampsia (high blood pressure, fluid retention and/ or protein in the
ali eklampsijo (s predeklampsijo povezane konvulzijske krče), zaradi katere je porod nujen,
- if the fetus has died
- če je plod odmrl,
- if you have a suspected infection of the uterus
- če obstaja sum, da imate okužbo maternice,
- if the placenta is covering the birth canal
- če posteljica prekriva porodni kanal,
- if the placenta is detaching
- če posteljica odstopa,
- if you or the fetus have conditions in which continuation of pregnancy are regarded undesirable
- če obstaja pri vas ali plodu kakšno stanje, zaradi katerega nadaljevanje nosečnosti ni zaželeno
hazardous
ali je nevarno,
- if you are allergic to atosiban or any of the other ingredients of TRACTOCILE
- če ste alergični na atosiban ali katerokoli sestavino TRACTOCILA.
Take special care with TRACTOCILE:
Bodite posebno pozorni pri uporabi TRACTOCILA:
- if premature rupture of your membranes cannot be excluded
- če ni mogoče izključiti prezgodnjega pretrganja plodovnih ovojnic,
- if you have kidney or liver problems
- če imate težave z ledvicami ali jetri,
- if the placenta is not in a normal position
- če posteljica ni v normalnem položaju,
- if you have a multiple pregnancy or a pregnancy between 24 and 27 weeks
- če imate večplodno nosečnost ali ste med 24. in 27. tednom nosečnosti,
- if contractions recur, treatment with TRACTOCILE can be repeated up to three more times
- če se popadki ponovijo, je mogoče zdravljenje s TRACTOCILOM do trikrat ponoviti,
- if the fetus is small for the time of pregnancy
- če je plod premajhen za konkretni čas nosečnosti.
- during treatment with TRACTOCILE, your contractions and the fetal heart rate may be
- Med zdravljenjem s TRACTOCILOM vam bodo morda nadzirali popadke in spremljali plodov
monitored
srčni utrip.
- after your baby has been delivered, TRACTOCILE may theoretically reduce the ability of the
- Po otrokovem rojstvu lahko TRACTOCILE teoretično zmanjša sposobnost maternice za
uterus to contract.
skrčitev.
Please tell your doctor, midwife or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
HOW TO USE TRACTOCILE
KAKO UPORABLJATI TRACTOCILE
TRACTOCILE is a medicine that is used only in hospital and should only be administered by qualified staff.
TRACTOCILE je zdravilo, ki se uporablja samo v bolnišnici in ga sme dajati le usposobljeno osebje.
Before using TRACTOCILE, the solution should be examined to ensure it is clear and free from particles.
Pred uporabo TRACTOCILA je treba raztopino pregledati in se prepričati, da je bistra in ne vsebuje delcev.
TRACTOCILE is given intravenously in three successive stages: • The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute. • A continuous infusion at a dose of 18 mg/ hour is given for 3 hours. • A continuous infusion at a dose of 6 mg/ hour is given for up to 45 hours, or until the contractions of the uterus have subsided.
TRACTOCILE se daje intravensko v treh zaporednih korakih: • Začetno intravensko injekcijo 6, 75 mg v 0, 9 ml se počasi eno minuto injicira v veno. • Sledi stalna infuzija z odmerkom 18 mg/ uro v teku 3 ur. • Stalna infuzija z odmerkom 6 mg/ uro se nadaljuje do 45 ur oz. dokler popadki ne popustijo.
The total duration of the treatment should be no more than 48 hours.
Celotno zdravljenje ne sme trajati več kot 48 ur. Če se popadki znova pojavijo, je mogoče uporabiti dodatne cikluse TRACTOCILA.
It is recommended that no more than three retreatments should be used during a pregnancy.
Priporočljivo je, da se ponovnega zdravljenja med posamezno nosečnostjo ne uporabi več kot trikrat.
Preparation of the intravenous infusion The intravenous infusion is prepared by diluting TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion in 0.9% w/ v sodium chloride solution, Ringer's lactate solution or 5% w/ v glucose solution.
Priprava intravenske infuzije:
This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Intravensko infuzijo se pripravi tako, da se TRACTOCILE 7, 5 mg/ ml, koncentrat za pripravo raztopine za infundiranje, razredči v 0, 9% (vol. / ut) raztopini natrijevega klorida, raztopini Ringerjevega laktata ali 5% (vol. / ut) raztopini glukoze. To se naredi tako, da se iz 100 ml infuzijske vrečke odvzame 10 ml in se jih nadomesti z 10 ml TRACTOCILE 7, 5 mg/ ml koncentrata za pripravo raztopine za infundiranje iz dveh 5 ml vial, tako da je dosežena koncentracija 75 mg atosibana v 100 ml.
If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Če se uporabi infuzijska vrečka z drugačno količino, je treba potrebni odmerek ustrezno preračunati.
TRACTOCILE should not be mixed with other medicinal products in the infusion bag.
TRACTOCILA se v infuzijski vrečki ne sme mešati z drugimi zdravili.
Like all medicines, TRACTOCILE can have side effects.
MOŽNI NEŽELENI UČINKI 29 Kot vsa zdravila ima lahko tudi TRACTOCILE neželene učinke.
The observed side effects for the mother were generally of a mild severity.
Opaženi neželeni učinki pri materi so bili praviloma blagi.
There are no known side effects on the fetus or new-born baby.
Pri plodu ali novorojenčku ni znanih neželenih učinkov.
For the mother the most commonly reported side effects are nausea, headache, dizziness, hot flushes, vomiting, rapid heart beat, low blood pressure, injection site reaction and high blood sugar.
Najpogosteje opisani neželeni učinki pri materi so slabost v želodcu, glavobol, omotica, valovi vročine, bruhanje, hitro bitje srca, nizek krvni tlak, reakcija na injekcijskem mestu in visoka koncentracija krvnega sladkorja.
Uncommon side effects include fever, insomnia, itching and rash.
Med občasnimi neželenimi učinki so zvišana telesna temperatura, nespečnost, srbenje in izpuščaj.
Rare side effects include a reduction in the ability of the uterus to contract after your baby has been delivered, which may cause bleeding.
Med redkimi neželenimi učinki so zmanjšana zmožnost maternice za skrčitev po porodu otroka, kar lahko povzroči krvavitve.
Allergic reaction has been rarely reported.
Redko so bile opisane alergijske reakcije.
If you notice these or any other side effects not mentioned in this leaflet, please inform your doctor, midwife or pharmacist.
Če opazite te ali katerekoli druge neželene učinke, ki niso omenjen v tem navodilu, obvestite zdravnika, babico ali farmacevta.
STORING TRACTOCILE
SHRANJEVANJE TRACTOCILA
Do not use TRACTOCILE if you notice particulate matter and discoloration prior to administration.
TRACTOCILA ne uporabite, če pred uporabo opazite, da so v njem delci ali je spremenjene barve.
FURTHER INFORMATION For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Storing TRACTOCILE 6.
Shranjevanje TRACTOCILA 6.
TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion atosiban
TRACTOCILE 7, 5 mg/ ml, koncentrat za pripravo raztopine za infundiranje Atosiban
Each vial of TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion, contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Ena viala TRACTOCILA 7, 5 mg/ ml, koncentrata za pripravo raztopine za infundiranje, vsebuje atosibanijev acetat, kolikor ustreza 37, 5 mg atosibana v 5 ml.
It is recommended that no more than three re- treatments should be used during a pregnancy.
Priporočljivo je, da se ponovnega zdravljenja med posamezno nosečnostjo ne uporabi več kot trikrat.
Preparation of the intravenous infusion The intravenous infusion is prepared by diluting TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion in 0.9% w/ v sodium chloride solution, Ringer's lactate solution or 5% w/ v glucose solution.
Intravensko infuzijo se pripravi tako, da se TRACTOCILE 7, 5 mg/ ml, koncentrat za pripravo raztopine za infundiranje, razredči v 0, 9% (vol. / ut) raztopini natrijevega klorida, raztopini Ringerjevega laktata ali 5% (vol. / ut) raztopini glukoze.
This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
To se naredi tako, da se iz 100 ml infuzijske vrečke odvzame 10 ml in se jih nadomesti z 10 ml TRACTOCILE 7, 5 mg/ ml koncentrata za pripravo raztopine za infundiranje iz dveh 5 ml vial, tako da je dosežena koncentracija 75 mg atosibana v 100 ml.
Like all medicines, TRACTOCILE can have side effects.
MOŽNI NEŽELENI UČINKI 34 Kot vsa zdravila ima lahko tudi TRACTOCILE neželene učinke.
There are no known side effects on the fetus or newborn baby.
Pri plodu ali novorojenčku ni znanih neželenih učinkov.
Do not use after the expiry date stated on the label
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Dilutions for intravenous administration must be used within 24 hours after preparation.
Razredčenja za intravensko aplikacijo je treba uporabiti v 24 urah po pripravi.
75 LT-2022 Vilnius Tel.: + 370 52 688 490
75 LT- 2022 Vilnius Tel.: + 370 52 688 490 Navodilo je bilo odobreno {datum}
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.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene raziskave, na podlagi katerih je oblikoval priporočila glede uporabe zdravila.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki so prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
What is TRAVATAN?
Kaj je zdravilo TRAVATAN?
TRAVATAN is a clear eye drop solution containing the active substance travoprost.
Zdravilo TRAVATAN je bistra raztopina kapljic za oči, ki vsebuje zdravilno učinkovino travoprost.
What is TRAVATAN used for?
Za kaj se zdravilo TRAVATAN uporablja?
TRAVATAN is used to reduce intraocular pressure (pressure inside the eye).
Zdravilo TRAVATAN se uporablja za zniževanje očesnega tlaka.
It is used in patients who have open angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in patients with ocular hypertension (when the pressure in the eye is higher than normal).
Uporablja se pri bolnikih, ki imajo glavkom z odprtim zakotjem (bolezen, pri kateri se očesni tlak zviša, ker tekočina ne more iztekati iz očesa), in pri bolnikih z okularno hipertenzijo (očesni tlak je višji od običajnega).
How is TRAVATAN used?
Kako se zdravilo TRAVATAN uporablja?
The dose is one drop of TRAVATAN in the affected eye(s) once a day, preferably in the evening.
Odmerek je ena kapljica zdravila TRAVATAN v prizadeto oko (prizadeti očesi) enkrat dnevno, najbolje zvečer.
TRAVATAN is not recommended for patients aged less than 18 years.
Zdravilo TRAVATAN ni priporočeno za bolnike do 18 leta starosti.
How does TRAVATAN work?
Kako zdravilo TRAVATAN deluje?
When intraocular pressure is raised, it causes damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Zvišan očesni tlak poškoduje mrežnico (za svetlobo občutljiva membrana na zadnji steni zrkla) in vidni živec, ki pošilja signale iz očesa v možgane.
This can result in serious vision loss and even blindness.
To lahko povzroči hudo izgubo vida in celo slepoto.
By lowering the pressure, TRAVATAN reduces the risk of damage.
Zdravilo TRAVATAN z zniževanjem tlaka zmanjša nevarnost poškodb.
The active substance in TRAVATAN, travoprost, is a prostaglandin analogue (a man-made copy of a natural substance, prostaglandin).
Zdravilna učinkovina zdravila TRAVATAN – travoprost – je analog prostaglandina (kopija v naravi obstoječe spojine – prostaglandina – ki jo izdela človek).
In the eye, prostaglandin increases the drainage of the watery fluid (aqueous humour) out of the eyeball.
Prostaglandin v očesu poveča odvajanje vodi podobne tekočine (očesna vodica) iz tega očesa.
TRAVATAN acts in the same way and increases the flow of fluid out of the eye.
Zdravilo TRAVATAN deluje na enak način in poveča odtok tekočine iz očesa.
This helps to reduce the pressure inside the eye.
Zdravilo tako pomaga znižati očesni tlak.
How has TRAVATAN been studied?
Kako je bilo zdravilo TRAVATAN raziskano?
TRAVATAN has been studied in 1,989 patients in three main studies, lasting between 6 and 12 months.
Zdravilo TRAVATAN so raziskali pri 1989 bolnikih v treh glavnih raziskavah, ki so trajale od 6 do 12 mesecev.
All three studies compared travoprost with timolol, which is the standard treatment for glaucoma.
V vseh treh raziskavah so zdravilno učinkovino travoprost primerjali z učinkovino timolol, ki se uporablja pri standardnem načinu zdravljenja glavkoma.