natgillin/translations-raw huggingface dataset:
There is insufficient clinical data on the use of tranexamic acid in pregnant women.
Ni dovolj kliničnih podatkov o uporabi traneksaminske kisline pri nosečnicah.
2.82 to 5.65
2,82 do 5,65
Not know (frequency cannot be estimated from the available data)
Drugi neželeni učinki (iz razpoložljivih podatkov njihove pogostnosti ni mogoče oceniti)
• oral contraceptives
• peroralne kontraceptive.
In vitro studies showed that high tranexamic dosages decreased the activity of complement.
In vitro študije so pokazale, da visoki odmerki traneksaminske kisline zmanjšajo aktivnost komplementa.
Attention should be paid to possible visual disturbances including visual impairment, vision blurred, impaired colour vision and if necessary the treatment should be discontinued.
Pozornost je treba nameniti možnim motnjam vida, vključno z okvaro vida, zamegljenim vidom, motnjo vida barv in po potrebi zdravljenje prekiniti.
10 mg/kg BW Every 12 hours
10 mg/kg telesne mase na vsakih 12 ur
If you have a risk of having blood clots.
• če imate tveganje za nastanek krvnih strdkov;
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.
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.
1.35 to 2.82
1,35 do 2,82
Method of administration The administration is strictly limited to slow intravenous injection.
Način uporabe Dajanje je strogo omejeno na počasno intravensko injiciranje.
- Convulsions particularly in case of misuse (refer to sections 4.3 and
- konvulzije, zlasti ob nepravilni uporabi (glejte poglavji 4.3 in 4.4)
It has been shown that convulsions tend to occur at higher frequency with increasing dose.
Dokazano je, da so konvulzije bolj pogoste pri večjih odmerkih.
- Malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration)
- slabo počutje s hipotenzijo, z ali brez izgube zavesti (običajno po prehitrem intravenskem injiciranju, izjemoma po peroralnem jemanju)
The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established.
Učinkovitost, odmerjanje in varnost traneksaminske kisline pri otrocih, ki bodo imeli operacijo na srcu, ni bila v celoti dokazana.
Use in patients with kidney problem
Uporaba pri bolnikih z ledvičnimi težavami
Due to the risk of cerebral oedema and convulsions, intrathecal and intraventricular injection and intracerebral application are not recommended.
Zaradi nevarnosti možganskega edema in epileptičnih krčev, intratekalno in intraventrikularno injiciranje ter intracerebralna uporaba niso priporočljivi.
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.
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.
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.
Čeprav raziskave na živalih ne kažejo teratogenih učinkov, traneksaminska kislina zaradi previdnosti ni priporočljiva v prvem trimesečju nosečnosti.
The ADRs reported from clinical studies and post-marketing experience are listed below according to system organ class.
Neželeni učinki, o katerih so poročali iz kliničnih študij in postmarketinških izkušenj, so navedeni spodaj (po organskih sistemih).
• have a condition called ‘consumption coagulopathy' where blood in the whole body starts to clot
• imate motnjo, imenovano "porabna koagulopatija", pri kateri pride do strjevanja krvi po celem telesu;
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA [dopolni država članica]
A complex involving tranexamic acid, plasminogen is constituted; the tranexamic acid being linked to plasminogen when transformed into plasmin.
Tvori se kompleks, ki vključuje traneksaminsko kislino in plazminogen; traneksaminska kislina je vezana na plazminogen, ko se ta preoblikuje v plazmin.
<Tranexamic acid - containing medicinal products> contains tranexamic acid which belongs to a group of medicines called antihaemorragics; antifibrinolitics, aminoacids.
Zdravilo <Zdravila, ki vsebujejo traneksaminsko kislino> vsebuje traneksaminsko kislino, ki spada v skupino zdravil, imenovanih antihemoragiki; antifibrinolitiki, aminokisline.
<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.
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.
4.4 Special warnings and precautions for use The indications and method of administration indicated above should be followed strictly:
Zgoraj navedene indikacije in način uporabe je treba dosledno upoštevati:
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.
Uporabo traneksaminske kisline je treba omejiti na tiste, pri katerih prevladuje aktivacija fibrinolitičnega sistema z akutno hudo krvavitvijo.
Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions)
• intratekalna in intraventrikularna injekcija, intracerebralna aplikacija (tveganje za možganski edem in konvulzije)
Tranexamic acid has been detected in semen where it inhibits fibrinolytic activity but does not influence sperm migration.
Traneksaminsko kislino so našli tudi v spermi, kjer zavira fibrinolitično aktivnost, vendar ne vpliva gibanje spermijev.
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).
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:
Patients with disseminated intravascular coagulation (DIC) should in most cases not be treated with tranexamic acid (see section 4.3).
Bolnikov z diseminirano intravaskularno koagulacijo (DIK) v večini primerov ne smemo zdraviti s traneksaminsko kislino (glejte poglavje 4.3).
• 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.
• 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;
Within each system organ class, adverse reactions are ranked by frequency.
V vsakem organskem sistemu so neželeni učinki razvrščeni po pogostnosti.
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>.
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>.
Fertility: There are no clinical data on the effects of Tranexamic acid on fertility.
Plodnost: Kliničnih podatkov o vplivu traneksaminske kisline na plodnost niso na voljo.
Epileptogenic activity has been observed in animals with intrathecal use of tranexamic acid.
Epileptogeno aktivnost so opazili pri živalih, pri katerih so traneksaminsko kislino uporabljali intratekalno.
Your doctor must use the minimal dose possible to avoid convulsions following treatment with <Tranexamic acid - containing medicinal products>
Vaš zdravnik mora uporabiti najmanjši možni odmerek, da bi preprečil epileptične krče po zdravljenju z zdravilom <zdravila, ki vsebujejo traneksaminsko kislino>.
For patient with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level:
Pri bolnikih z blago do zmerno okvaro ledvic, je treba odmerek traneksaminske kisline znižati glede na raven serumskega kreatinina:
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.
Po intravenskem injiciranju 10 mg/kg pri 17 bolnikih po kirurškem posegu kolena so bile koncentracije v sklepni tekočini podobne koncentracijam ustreznih vzorcev seruma.
Plasma concentrations increase in patients with renal failure.
Plazemske koncentracije so povečane pri bolnikih z ledvično odpovedjo.
Use in patients with hepatic impairment No reduction in dosage is necessary.
Uporaba pri bolnikih z okvarjenim delovanjem jeter Zmanjšanje odmerka ni potrebno.
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).
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).
[To be completed nationally]
[dopolni država članica]
The activity of the tranexamic acid-plasmin complex on the activity on fibrin is lower than the activity of free plasmin alone.
Učinek kompleksa traneksaminske kisline-plazmina na aktivnost fibrina je manjši od učinka prostega plazmina.
Tranexamic acid diffuses rapidly into joint fluid and the synovial membrane.
Traneksaminska kislina hitro difundira v sklepno tekočino in sinovialno ovojnico.
6.4 Special precautions for storage [To be completed nationally]
6.4 Posebna navodila za shranjevanje [dopolni država članica]
Peak plasma concentrations of tranexamic acid are obtained rapidly after a short intravenous infusion after which plasma concentrations decline in a multi-exponential manner.
Koncentracija traneksaminske kisline je najvišja zelo hitro po kratki intravenski infuziji, po kateri plazemska koncentracija pada na več-eksponentni način.
No specific PK study has been conducted in children.
Specifičnih farmakokinetičnih študij pri otrocih niso naredili.
<Tranexamic acid - containing medicinal products> must not be injected into a muscle.
<Zdravila, ki vsebujejo traneksaminsko kislino> se ne sme injicirati v mišico.
Alternatively, the antifibrinolytic action of the drug may be antagonised with thrombolytic drugs.
Antifibrinolitično delovanje zdravila lahko antagoniziramo s trombolitiki.
Driving and using machines No studies have been performed on the ability to drive and use machines.
Sposobnost vožnje in upravljanja s stroji Študije sposobnosti vožnje in upravljanja s stroji niso bile narejene.
6.2 Incompatibilities [To be completed nationally]
6.2 Inkompatibilnosti [dopolni država članica]
- If you get any side effects, talk to your doctor or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
• Tranexamic acid should not be administered by the intramuscular route.
• traneksaminske kisline se ne sme dajati intramuskularno.
While studied in very few patients, the limited data suggest that continuous infusion is preferable, since it would maintain therapeutic plasma concentration throughout surgery.
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.
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.
Omejene klinične izkušnje z uporabo traneksaminske kisline v različnih primerih krvavitev v drugem in tretjem trimesečju nosečnosti niso pokazale škodljivega učinka na plod.
If you are given more <Tranexamic acid - containing medicinal products> than the recommended dose you may experience a transitory blood pressure lowering.
Če ste dobili večji odmerek zdravila <zdravila, ki vsebujejo traneksaminsko kislino> od priporočenega odmerka, se vam lahko prehodno zniža krvni tlak.
• effects on the eyes : vision disturbances including impaired color vision
- učinki na oči: motnje vida, vključno z motnjami vida barv
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.
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.
Literature review identified 12 efficacy studies in paediatric cardiac surgery which have included 1073 children, 631 having received tranexamic acid.
V študijah je bilo vključeno 1073 otrok, od tega jih je 631 prejemalo traneksaminsko kislino.
• other medicines that help blood to clot called antifibrinolytic medicines
• druga zdravila, ki pomagajo pri strjevanju krvi, t. i. antifibrinolitiki;
[See Annex I - To be completed nationally]
[glejte Dodatek I - dopolni država članica]
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.
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.
• medicines that prevent blood clotting, called thrombolytic medicines
• zdravila, ki preprečujejo strjevanje krvi, t. i. trombolitiki;
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.
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).
Therefore, the use of <Tranexamic acid - containing medicinal products> during breast-feeding is not recommended.
Zato uporaba <zdravil, ki vsebujejo traneksaminsko kislino> med dojenjem ni priporočljiva.
• If you have had blood in your urine <Tranexamic acid - containing medicinal products> it may be lead to urinary tract obstruction.
• če ste imeli kri v urinu <zdravila, ki vsebujejo traneksaminsko kislino> je morda povzročilo obstrukcijo sečnega trakta;
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.
Če raztopino za injiciranje <zdravila, ki vsebujejo traneksaminsko kislino> dajemo otroku od enega leta, se odmerek določi na osnovi telesne mase otroka.
- Hypersensitivity reactions including anaphylaxis
- preobčutljivostne reakcije, vključno z anafilakso
• effects on the nervous system: convulsions
- učinki na živčni sistem: epileptični krči
Use in elderly No reduction in dosage is necessary unless there is evidence of renal failure.
Uporaba pri starejših Zmanjšanje odmerka ni potrebno, razen pri dokazani ledvični odpovedi.
Adverse reactions are listed according to MedDRA primary system organ class.
Neželeni učinki so razvrščeni v skladu s klasifikacijo MedDRA po organskih sistemih.
Haematuria In case of haematuria from the upper urinary tract, there is a risk for urethral obstruction.
Hematurija Če pride do hematurije iz zgornjih sečil se poveča tveganje za obstrukcijo sečnice.
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.
Uporaba pri odraslih <Zdravila, ki vsebujejo traneksaminsko kislino>, raztopina za injiciranje, boste prejeli s počasnim injiciranjem v veno.
• have currently a disease leading to blood clots
• imate bolezen, zaradi katere se vam tvorijo krvni strdki;
Breastfeeding: Tranexamic acid is excreted in human milk.
Dojenje: Traneksaminska kislina se izloča v materino mleko.
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.
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.
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.
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.
Tranexamic acid exerts an anti haemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.
Traneksaminska kislina deluje antihemoragično in sicer tako, da zavira fibrinolitične lastnosti plazmina.
10 mg/kg BW Every 24 hours 5 mg/kg BW
10 mg kg telesne mase na vsakih 24 ur 5 mg/kg telesne mase na vsakih 24 ur
Adverse reactions reported are presented in table below.
Neželeni učinki so predstavljeni v tabeli.
Thromboembolic events
Tromboembolični zapleti
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).
Pri ledvična insuficienci, kjer je)povečano tveganje za kopičenje, je pri bolnikih s hudo okvaro ledvic uporaba traneksaminske kisline kontraindicirana (glejte poglavje 4.3).
Most of them were controlled versus placebo.
Večina študij je bila nadzorovana - traneksaminsko kislino so primerjali s placebom.
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:
• 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:
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Imetnik dovoljenja za promet z zdravilom in izdelovalec [glejte Dodatek I - dopolni država članica] {Ime in naslov} <{tel}> <{fax}> <{e-mail}>
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.
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.
- Dermatitis allergic
- alergijski dermatitis bolezni prebavil pogosto
Medicinal products that act on haemostasis should be given with caution to patients treated with tranexamic acid.
Pri bolnikih, ki se zdravijo s traneksaminsko kislino je potrebna previdnost pri uporabi zdravil, ki delujejo na hemostazo.
- Arterial or venous thrombosis at any sites
- arterijska ali venska tromboza na katerem koli mestu bolezni imunskega sistema ni znano
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.
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.
Undesirable Effects
Možni neželeni učinki
Tranexamic acid passes through the placenta.
Traneksaminska kislina prehaja skozi placento.
- Visual disturbances including impaired colour vision
- motnje vida, vključno z motnjami barvnega vida žilne bolezni ni znano
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.
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.
6.5 Nature and contents of container [To be completed nationally]
6.5 Vrsta ovojnine in vsebina [dopolni država članica]
Hypersensitivity to the active substance or to any of its excipients listed in section 6.1.
• preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju
There is a theoretical risk of increased thrombus-formation potential, such as with oestrogens.
Teoretično je tveganje za nastanek trombusov (krvnih strdov) večje kot pri zdravljenju z estrogeni.
Elderly: No reduction in dosage is necessary unless there is evidence of renal failure.
Starejši Zmanjšanje odmerka ni potrebno, razen pri dokazani ledvični odpovedi.
• have kidney problems.
• imate težave z ledvicami;
Standard treatment of general fibrinolysis: 1 g (1 ampule of 10 ml or 2 ampules of 5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) every 6 to 8 hours, equivalent to 15 mg/kg BW
1 g (1 ampula po 10 ml ali 2 ampuli po 5 ml) traneksaminske kisline, počasno intravensko injiciranje (= 1 ml/minuto) vsakih 6 do 8 ur, kar ustreza 15 mg / kg telesne mase.