FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies showed that high tranexamic dosages decreased the activity of complement.
Slovenian: In vitro študije so pokazale, da visoki odmerki traneksaminske kisline zmanjšajo aktivnost komplementa.
English: Attention should be paid to possible visual disturbances including visual impairment, vision blurred, impaired colour vision and if necessary the treatment should be discontinued.
Slovenian: Pozornost je treba nameniti možnim motnjam vida, vključno z okvaro vida, zamegljenim vidom, motnjo vida barv in po potrebi zdravljenje prekiniti.
English: 10 mg/kg BW Every 12 hours
Slovenian: 10 mg/kg telesne mase na vsakih 12 ur
English: If you have a risk of having blood clots.
Slovenian: • če imate tveganje za nastanek krvnih strdkov;
English: In children from 1 year, for current approved indications as described in section 4.1, the dosage is in the region of 20 mg/kg/day.
Slovenian: Za trenutno odobrene indikacije, ki so opisane v poglavju 4.1, je pri otrocih od 1 leta dalje odmerek v območju 20 mg/kg /dan.
English: 1.35 to 2.82
Slovenian: 1,35 do 2,82
English: Method of administration The administration is strictly limited to slow intravenous injection.
Slovenian: Način uporabe Dajanje je strogo omejeno na počasno intravensko injiciranje.
English: - Convulsions particularly in case of misuse (refer to sections 4.3 and
Slovenian: - konvulzije, zlasti ob nepravilni uporabi (glejte poglavji 4.3 in 4.4)
English: It has been shown that convulsions tend to occur at higher frequency with increasing dose.
Slovenian: Dokazano je, da so konvulzije bolj pogoste pri večjih odmerkih.
English: - Malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration)
Slovenian: - slabo počutje s hipotenzijo, z ali brez izgube zavesti (običajno po prehitrem intravenskem injiciranju, izjemoma po peroralnem jemanju)
English: The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established.
Slovenian: Učinkovitost, odmerjanje in varnost traneksaminske kisline pri otrocih, ki bodo imeli operacijo na srcu, ni bila v celoti dokazana.
English: Use in patients with kidney problem
Slovenian: Uporaba pri bolnikih z ledvičnimi težavami
English: Due to the risk of cerebral oedema and convulsions, intrathecal and intraventricular injection and intracerebral application are not recommended.
Slovenian: Zaradi nevarnosti možganskega edema in epileptičnih krčev, intratekalno in intraventrikularno injiciranje ter intracerebralna uporaba niso priporočljivi.
English: Characteristically, the haematological profile approximates to the following: reduced euglobulin clot lysis time; prolonged prothrombin time; reduced plasma levels of fibrinogen, factors V and VIII, plasminogen fibrinolysin and alpha-2 macroglobulin; normal plasma levels of P and P complex; i.e. factors II (prothrombin), VIII and X; increased plasma levels of fibrinogen degradation products; a normal platelet count.
Slovenian: Hematološki profil je približno tak: zmanjšana fibrinolitična aktivnost plazme (ELT, euglobulin clot lysis time), podaljšan protrombinski čas, znižane plazemske vrednosti fibrinogena, faktorjev V in VIII, plazminogena fibrinolizina in alfa-2 makroglobulina; normalne plazemske vrednosti P in kompleksa P, to je faktorjev II (protrombina), VIII in X; povečane plazemske vrednosti razgradnih produktov fibrinogena; normalno število trombocitov.
English: As a result, although studies in animals do not indicate teratogenic effects, as precaution for use, tranexamic acid is not recommended during the first trimester of pregnancy.
Slovenian: Čeprav raziskave na živalih ne kažejo teratogenih učinkov, traneksaminska kislina zaradi previdnosti ni priporočljiva v prvem trimesečju nosečnosti.
English: The ADRs reported from clinical studies and post-marketing experience are listed below according to system organ class.
Slovenian: Neželeni učinki, o katerih so poročali iz kliničnih študij in postmarketinških izkušenj, so navedeni spodaj (po organskih sistemih).
English: • have a condition called ‘consumption coagulopathy' where blood in the whole body starts to clot
Slovenian: • imate motnjo, imenovano "porabna koagulopatija", pri kateri pride do strjevanja krvi po celem telesu;
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA [dopolni država članica]
English: Disseminated intravascular coagulation
Slovenian: Diseminirana intravaskularna koagulacija
English: A complex involving tranexamic acid, plasminogen is constituted; the tranexamic acid being linked to plasminogen when transformed into plasmin.
Slovenian: Tvori se kompleks, ki vključuje traneksaminsko kislino in plazminogen; traneksaminska kislina je vezana na plazminogen, ko se ta preoblikuje v plazmin.
English: <Tranexamic acid - containing medicinal products> contains tranexamic acid which belongs to a group of medicines called antihaemorragics; antifibrinolitics, aminoacids.
Slovenian: Zdravilo <Zdravila, ki vsebujejo traneksaminsko kislino> vsebuje traneksaminsko kislino, ki spada v skupino zdravil, imenovanih antihemoragiki; antifibrinolitiki, aminokisline.
English: <Tranexamic acid - containing medicinal products> is used in adults and children above one year of age for the prevention and treatment of bleeding due to a process that inhibits blood clotting called fibrinolysis.
Slovenian: Zdravilo <zdravila, ki vsebujejo traneksaminsko kislino> se uporablja pri odraslih in otrocih nad enim letom starosti, za preprečevanje in zdravljenje krvavitev zaradi fibrinolize, tj. procesa, ki zavira strjevanje krvi.
English: 4.4 Special warnings and precautions for use The indications and method of administration indicated above should be followed strictly:
Slovenian: Zgoraj navedene indikacije in način uporabe je treba dosledno upoštevati:
English: If tranexamic acid is given it must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding.
Slovenian: Uporabo traneksaminske kisline je treba omejiti na tiste, pri katerih prevladuje aktivacija fibrinolitičnega sistema z akutno hudo krvavitvijo.
English: Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions)
Slovenian: • intratekalna in intraventrikularna injekcija, intracerebralna aplikacija (tveganje za možganski edem in konvulzije)
English: Tranexamic acid has been detected in semen where it inhibits fibrinolytic activity but does not influence sperm migration.
Slovenian: Traneksaminsko kislino so našli tudi v spermi, kjer zavira fibrinolitično aktivnost, vendar ne vpliva gibanje spermijev.
English: The concentration of tranexamic acid in a number of other tissues is a fraction of that observed in the blood (breast milk, one hundredth; cerebrospinal fluid, one tenth; aqueous humor, one tenth).
Slovenian: Koncentracija traneksaminske kisline v številnih drugih tkivih predstavlja le del tiste, ki so jo ugotovili v krvi (v materinem mleku: 1/100, v cerebrospinalni tekočini: 1/10, v prekatni vodici:
English: Patients with disseminated intravascular coagulation (DIC) should in most cases not be treated with tranexamic acid (see section 4.3).
Slovenian: Bolnikov z diseminirano intravaskularno koagulacijo (DIK) v večini primerov ne smemo zdraviti s traneksaminsko kislino (glejte poglavje 4.3).
English: • If you have excessive clotting or bleeding throughout your body (disseminated intravascular coagulation), <Tranexamic acid - containing medicinal products> may not be right for you, except if you have acute severe bleeding and blood test have shown the process that inhibits blood clotting called fibrinolysis is activated.
Slovenian: • če se vaša kri prekomerno strjuje ali imate krvavitve po celotnem telesu (diseminirana intravaskularna koagulacija), zdravilo <zdravila, ki vsebujejo traneksaminsko kislino> morda ni pravo za vas, razen če imate akutno hudo krvavitev, rezultati krvnega testa pa so pokazali, da se je aktiviral proces, ki zavira strjevanje krvi, t. i. fibrinoliza;
English: Within each system organ class, adverse reactions are ranked by frequency.
Slovenian: V vsakem organskem sistemu so neželeni učinki razvrščeni po pogostnosti.
English: If you think any of these apply to you, or if you are in any doubt at all, tell your doctor before taking <Tranexamic acid - containing medicinal products>.
Slovenian: Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakor koli v dvomih, povejte svojemu zdravniku pred začetkom jemanja <zdravila, ki vsebujejo traneksaminsko kislino>.
English: Fertility: There are no clinical data on the effects of Tranexamic acid on fertility.
Slovenian: Plodnost: Kliničnih podatkov o vplivu traneksaminske kisline na plodnost niso na voljo.
English: Epileptogenic activity has been observed in animals with intrathecal use of tranexamic acid.
Slovenian: Epileptogeno aktivnost so opazili pri živalih, pri katerih so traneksaminsko kislino uporabljali intratekalno.
English: Your doctor must use the minimal dose possible to avoid convulsions following treatment with <Tranexamic acid - containing medicinal products>
Slovenian: Vaš zdravnik mora uporabiti najmanjši možni odmerek, da bi preprečil epileptične krče po zdravljenju z zdravilom <zdravila, ki vsebujejo traneksaminsko kislino>.
English: For patient with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level:
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic, je treba odmerek traneksaminske kisline znižati glede na raven serumskega kreatinina:
English: Following administration of an intravenous injection of 10 mg/kg to 17 patients undergoing knee surgery, concentrations in the joint fluids were similar to those seen in corresponding serum samples.
Slovenian: Po intravenskem injiciranju 10 mg/kg pri 17 bolnikih po kirurškem posegu kolena so bile koncentracije v sklepni tekočini podobne koncentracijam ustreznih vzorcev seruma.
English: Plasma concentrations increase in patients with renal failure.
Slovenian: Plazemske koncentracije so povečane pri bolnikih z ledvično odpovedjo.
English: Use in patients with hepatic impairment No reduction in dosage is necessary.
Slovenian: Uporaba pri bolnikih z okvarjenim delovanjem jeter Zmanjšanje odmerka ni potrebno.
English: In patients with a history of thromboembolic diseases or in those with increased incidence of thromboembolic events in their family history (patients with a high risk of thrombophilia), Tranexamic acid solution for injection should only be administered if there is a strong medical indication after consulting a physician experienced in hemostaseology and under strict medical supervision (see section 4.3).
Slovenian: Pri bolnikih z anamnezo trombemboličnih bolezni ali pri tistih z večjo pojavnostjo trombemboličnih dogodkov v družinski anamnezi (bolniki z visokim tveganjem za trombofilijo), se traneksaminska kislina, raztopina za injiciranje, sme dajati le, če obstaja močna medicinska indikacija - po posvetu z zdravnikom, ki ima izkušnje v hemostaziologiji in pod strogim zdravniškim nadzorom (glejte poglavje 4.3).
English: [To be completed nationally]
Slovenian: [dopolni država članica]
English: The activity of the tranexamic acid-plasmin complex on the activity on fibrin is lower than the activity of free plasmin alone.
Slovenian: Učinek kompleksa traneksaminske kisline-plazmina na aktivnost fibrina je manjši od učinka prostega plazmina.
English: Tranexamic acid diffuses rapidly into joint fluid and the synovial membrane.
Slovenian: Traneksaminska kislina hitro difundira v sklepno tekočino in sinovialno ovojnico.
English: 6.4 Special precautions for storage [To be completed nationally]
Slovenian: 6.4 Posebna navodila za shranjevanje [dopolni država članica]
English: Peak plasma concentrations of tranexamic acid are obtained rapidly after a short intravenous infusion after which plasma concentrations decline in a multi-exponential manner.
Slovenian: Koncentracija traneksaminske kisline je najvišja zelo hitro po kratki intravenski infuziji, po kateri plazemska koncentracija pada na več-eksponentni način.
English: No specific PK study has been conducted in children.
Slovenian: Specifičnih farmakokinetičnih študij pri otrocih niso naredili.
English: <Tranexamic acid - containing medicinal products> must not be injected into a muscle.
Slovenian: <Zdravila, ki vsebujejo traneksaminsko kislino> se ne sme injicirati v mišico.
English: Alternatively, the antifibrinolytic action of the drug may be antagonised with thrombolytic drugs.
Slovenian: Antifibrinolitično delovanje zdravila lahko antagoniziramo s trombolitiki.
English: Driving and using machines No studies have been performed on the ability to drive and use machines.
Slovenian: Sposobnost vožnje in upravljanja s stroji Študije sposobnosti vožnje in upravljanja s stroji niso bile narejene.
English: 6.2 Incompatibilities [To be completed nationally]
Slovenian: 6.2 Inkompatibilnosti [dopolni država članica]
English: - If you get any side effects, talk to your doctor or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
English: • Tranexamic acid should not be administered by the intramuscular route.
Slovenian: • traneksaminske kisline se ne sme dajati intramuskularno.
English: While studied in very few patients, the limited data suggest that continuous infusion is preferable, since it would maintain therapeutic plasma concentration throughout surgery.
Slovenian: Ker je bilo v študije vključenih zelomalo bolnikov, je podatkov malo, vendar pa ti kažejo, da je boljša kontinuirana infuzija, saj med kirurškim posegom ohranja terapevtsko koncentracijo.
English: Limited clinical of the use of tranexamic acid in different clinical haemorrhagic settings during the second and third trimesters did not identify deleterious effect for the foetus.
Slovenian: Omejene klinične izkušnje z uporabo traneksaminske kisline v različnih primerih krvavitev v drugem in tretjem trimesečju nosečnosti niso pokazale škodljivega učinka na plod.
English: If you are given more <Tranexamic acid - containing medicinal products> than the recommended dose you may experience a transitory blood pressure lowering.
Slovenian: Če ste dobili večji odmerek zdravila <zdravila, ki vsebujejo traneksaminsko kislino> od priporočenega odmerka, se vam lahko prehodno zniža krvni tlak.
English: • effects on the eyes : vision disturbances including impaired color vision
Slovenian: - učinki na oči: motnje vida, vključno z motnjami vida barv
English: The most adapted dosing schedule appeared to be: - first bolus of 10 mg/kg after induction of anaesthesia and prior to skin incision, - continuous infusion of 10 mg/kg/h or injection into the CPB pump prime at a dose adapted on the CPB procedure, either according to a patient weight with a dose of 10 mg/kg dose, either according to CPB pump prime volume, last injection of 10 mg/kg at the end of CPB.
Slovenian: Najbolj prilagojeni načrt odmerjanja je: - prvi bolus: 10 mg/kg po indukciji v anestezijo in pred rezom v kožo, - kontinuirana infuzija 10 mg/kg /h ali injiciranje v CPB črpalko v odmerku, prilagojenem v postopku CPB, bodisi skladno s telesno maso bolnika (odmerek 10 mg/kg) bodisi glede na volumen CPB črpalke; zadnje injiciranje po 10 mg/kg na koncu kardiopulmonalnega obvoda.
English: Literature review identified 12 efficacy studies in paediatric cardiac surgery which have included 1073 children, 631 having received tranexamic acid.
Slovenian: V študijah je bilo vključeno 1073 otrok, od tega jih je 631 prejemalo traneksaminsko kislino.
English: • other medicines that help blood to clot called antifibrinolytic medicines
Slovenian: • druga zdravila, ki pomagajo pri strjevanju krvi, t. i. antifibrinolitiki;
English: [See Annex I - To be completed nationally]
Slovenian: [glejte Dodatek I - dopolni država članica]
English: Following administration of an intravenous injection of 10 mg/kg to 12 pregnant women, the concentration of tranexamic acid in serum ranged 10-53 μg/mL while that in cord blood ranged 4-31 μg/mL.
Slovenian: Po intravenskem injiciranju 10 mg/kg pri 12 nosečnicah je bila koncentracija traneksaminske kisline v serumu od 10 do 53 μg / ml, v popkovnični krvi pa od 4 do 31μ g/ml.
English: • medicines that prevent blood clotting, called thrombolytic medicines
Slovenian: • zdravila, ki preprečujejo strjevanje krvi, t. i. trombolitiki;
English: With continuous long-term use of TXA solution for injection, regular ophthalmologic examinations (eye examinations including visual acuity, colour vision, fundus, visual field etc.) are indicated.
Slovenian: Pri stalni, dolgotrajni uporabi TXA raztopine za injiciranje, so indicirani redni oftalmološki pregledi (očesni pregledi, vključno z ostrino vida, pregledom barvnega vida, očesnega ozadja (fundusa), preiskavo vidnega polja itd).
English: Therefore, the use of <Tranexamic acid - containing medicinal products> during breast-feeding is not recommended.
Slovenian: Zato uporaba <zdravil, ki vsebujejo traneksaminsko kislino> med dojenjem ni priporočljiva.
English: • If you have had blood in your urine <Tranexamic acid - containing medicinal products> it may be lead to urinary tract obstruction.
Slovenian: • če ste imeli kri v urinu <zdravila, ki vsebujejo traneksaminsko kislino> je morda povzročilo obstrukcijo sečnega trakta;
English: If <Tranexamic acid - containing medicinal products> solution for injection is given to a child from one year, the dose will be based on the child's weight.
Slovenian: Če raztopino za injiciranje <zdravila, ki vsebujejo traneksaminsko kislino> dajemo otroku od enega leta, se odmerek določi na osnovi telesne mase otroka.
English: - Hypersensitivity reactions including anaphylaxis
Slovenian: - preobčutljivostne reakcije, vključno z anafilakso
English: • effects on the nervous system: convulsions
Slovenian: - učinki na živčni sistem: epileptični krči
English: Use in elderly No reduction in dosage is necessary unless there is evidence of renal failure.
Slovenian: Uporaba pri starejših Zmanjšanje odmerka ni potrebno, razen pri dokazani ledvični odpovedi.
English: Adverse reactions are listed according to MedDRA primary system organ class.
Slovenian: Neželeni učinki so razvrščeni v skladu s klasifikacijo MedDRA po organskih sistemih.
English: Haematuria In case of haematuria from the upper urinary tract, there is a risk for urethral obstruction.
Slovenian: Hematurija Če pride do hematurije iz zgornjih sečil se poveča tveganje za obstrukcijo sečnice.
English: How to take Use in Adults <Tranexamic acid - containing medicinal products>solution for injection will be given to you by slow injection into a vein.
Slovenian: Uporaba pri odraslih <Zdravila, ki vsebujejo traneksaminsko kislino>, raztopina za injiciranje, boste prejeli s počasnim injiciranjem v veno.
English: • have currently a disease leading to blood clots
Slovenian: • imate bolezen, zaradi katere se vam tvorijo krvni strdki;
English: Breastfeeding: Tranexamic acid is excreted in human milk.
Slovenian: Dojenje: Traneksaminska kislina se izloča v materino mleko.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Standard treatment of local fibrinolysis: 0.5 g (1 ampule of 5 ml) to 1 g (1 ampule of 10 ml or 2 ampules of 5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) two to three times daily 2.
Slovenian: 0,5 g (1 ampula po 5 ml) do 1 g (1 ampula po 10 ml ali 2 ampuli po 5 ml) traneksaminske kisline, počasno intravensko injiciranje (= 1 ml / minuto) dva-do trikrat dnevno.
English: Tranexamic acid exerts an anti haemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.
Slovenian: Traneksaminska kislina deluje antihemoragično in sicer tako, da zavira fibrinolitične lastnosti plazmina.
English: 10 mg/kg BW Every 24 hours 5 mg/kg BW
Slovenian: 10 mg kg telesne mase na vsakih 24 ur 5 mg/kg telesne mase na vsakih 24 ur
English: Adverse reactions reported are presented in table below.
Slovenian: Neželeni učinki so predstavljeni v tabeli.
English: Thromboembolic events
Slovenian: Tromboembolični zapleti
English: In renal insufficiency leading to a risk of accumulation, the use of tranexamic acid is contraindicated in patient with severe renal impairment (see section 4.3).
Slovenian: Pri ledvična insuficienci, kjer je)povečano tveganje za kopičenje, je pri bolnikih s hudo okvaro ledvic uporaba traneksaminske kisline kontraindicirana (glejte poglavje 4.3).
English: Most of them were controlled versus placebo.
Slovenian: Večina študij je bila nadzorovana - traneksaminsko kislino so primerjali s placebom.
English: Warnings and precautions Tell your doctor if any of these apply to you to help him or her decide if <Tranexamic acidcontaining medicinal products> is suitable for you:
Slovenian: • Obvestite zdravnika, če karkoli od navedenega velja za vas, da mu oz. ji pomagate pri odločitvi, ali je zdravilo <zdravila, ki vsebujejo traneksaminsko kislino> primerno za vas:
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [glejte Dodatek I - dopolni država članica] {Ime in naslov} <{tel}> <{fax}> <{e-mail}>
English: Study results with tranexamic acid suggest reduced blood loss and reduced blood product requirements in paediatric cardiac surgery under cardiopulmonary bypass (CPB) where there is a high risk of haemorrhage, especially in cyanotic patients or patients undergoing repeat surgery.
Slovenian: Rezultati študije kažejo, da traneksaminska kislina pri pediatričnih kirurških posegih na srcu - kardiopulmonalni obvod (CPB, cardiopulmonary bypass) , pri katerih obstaja velika nevarnost krvavitve, zlasti pri cianotičnih bolnikih ali pri bolnikih, pri katerih je treba operacijo ponoviti, zmanjša izgubo krvi in potrebo po krvnih pripravkih.
English: - Dermatitis allergic
Slovenian: - alergijski dermatitis bolezni prebavil pogosto
English: Medicinal products that act on haemostasis should be given with caution to patients treated with tranexamic acid.
Slovenian: Pri bolnikih, ki se zdravijo s traneksaminsko kislino je potrebna previdnost pri uporabi zdravil, ki delujejo na hemostazo.
English: - Arterial or venous thrombosis at any sites
Slovenian: - arterijska ali venska tromboza na katerem koli mestu bolezni imunskega sistema ni znano
English: With pathological ophthalmic changes, particularly with diseases of the retina, the physician must decide after consulting a specialist on the necessity for the long-term use of TXA solution for injection in each individual case.
Slovenian: Če so prisotne patološke spremembe, zlasti bolezni mrežnice, mora zdravnik po posvetu s specialistom odločiti, ali je dolgotrajno jemanje TXA raztopine za injiciranje, primerno za posameznega bolnika.
English: Undesirable Effects
Slovenian: Možni neželeni učinki
English: Tranexamic acid passes through the placenta.
Slovenian: Traneksaminska kislina prehaja skozi placento.
English: - Visual disturbances including impaired colour vision
Slovenian: - motnje vida, vključno z motnjami barvnega vida žilne bolezni ni znano
English: With pathological ophthalmic changes, particularly with diseases of the retina, your doctor must take a decision after consulting a specialist on the necessity for the long-term use of <Tranexamic acid-containing medicinal products> solution for injection in your case.
Slovenian: Če so prisotne patološke spremembe, zlasti bolezni mrežnice, mora vaš zdravnik po posvetu s specialistom odločiti, ali je dolgotrajno jemanje <zdravila, ki vsebujejo traneksaminsko kislino> raztopine za injiciranje za vas primerno.
English: 6.5 Nature and contents of container [To be completed nationally]
Slovenian: 6.5 Vrsta ovojnine in vsebina [dopolni država članica]