FrancophonIA/ELRC3.0 huggingface dataset:
English: The need for effective contraception in women of childbearing potential during and up to eight months after treatment.
Slovenian: Potreba po zanesljivi kontracepciji pri ženskah v rodni dobi med zdravljenjem in do osem mesecev po zdravljenju.
English: Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported in patients treated with other terminal complement inhibitors.
Slovenian: Pri bolnikih, zdravljenih z drugimi inhibitorji terminalnega komplementa, so poročali o resnih okužbah z vrsto Neisseria (poleg bakterije Neisseria meningitidis), vključno z diseminiranimi gonokoknimi okužbami.
English: Ultomiris must be diluted to a final concentration of 5 mg/mL.
Slovenian: Zdravilo Ultomiris je treba razredčiti do končne koncentracije 5 mg/ml.
English: Animal reproductive toxicology studies have not been conducted with ravulizumab, but were conducted in mice with a murine surrogate complement inhibitory antibody, BB5.1.
Slovenian: Študij vpliva na sposobnost razmnoževanja z ravulizumabom na živalih niso izvedli, pač pa so jih izvedli na miših z mišjim nadomestnim protitelesom, ki inhibira komplement, BB5.1.
English: The other ingredients are: - sodium dihydrogen phosphate dihydrate - disodium phosphate dihydrate - sodium chloride - polysorbate 80 Solvent: water for injections
Slovenian: − Druge sestavine zdravila so: - natrijev dihidrogenfosfat dihidrat, - natrijev fosfat dihidrat, - natrijev klorid, - polisorbat 80.
English: Patients with unresolved Neisseria meningitidis infection at treatment initiation (see section Patients who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see section
Slovenian: Bolniki, ki niso bili nedavno cepljeni proti bakteriji Neisseria meningitidis, razen če prejmejo profilaktično zdravljenje z ustreznimi antibiotiki, ki traja do 2 tedna po cepljenju (glejte poglavje 4.4).
English: Nonclinical reproductive toxicology studies conducted in mice with a murine surrogate molecule (BB5.1) identified no adverse effect on fertility of the treated females or males.
Slovenian: V predkliničnih reproduktivnih toksikoloških študijah, izvedenih na miših z mišjo nadomestno molekulo (BB5.1), niso ugotovili neželenih učinkov na plodnost samic in samcev, ki so prejemali zdravilo.
English: Table 4: Baseline characteristics in the complement-inhibitor naïve study Parameter
Slovenian: Preglednica 4: Izhodiščne značilnosti v študiji brez predhodnega inhibitorja komplementa
English: What you need to know before you use Ultomiris Do not use Ultomiris:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ultomiris
English: Eculizumab (N = 121)
Slovenian: Ekulizumab (N = 121)
English: Clear to translucent, slight whitish colour, pH 7.0 solution.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra do prosojna raztopina rahlo belkaste barve s pH 7,0.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Za navodila glede redčenja zdravila pred uporabo glejte poglavje 6.6. 4.3 Kontraindikacije Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: No clear treatment-related effects or adverse effects were observed in the murine surrogate reproductive toxicology studies in mice.
Slovenian: Opazili niso nobenih učinkov nedvoumno povezanih z zdravljenjem, ali neželenih učinkov v študijah vpliva na sposobnost razmnoževanja na miših z mišjim nadomestkom.
English: There were no noteworthy differences in the demographic or baseline characteristics between the ravulizumab and eculizumab treatment groups in either of the Phase 3 studies.
Slovenian: Med skupinama, ki so ju zdravili z ravulizumabom oziroma ekulizumabom v študijah 3. faze, ni bilo omembe vrednih razlik v demografskih ali izhodiščnih značilnostih.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: No specific non-clinical study on fertility has been conducted with ravulizumab.
Slovenian: Posebne predklinične študije o vplivu ravulizumaba na plodnost niso bile izvedene.
English: Ultomiris requires dilution to a final concentration of 5 mg/mL.
Slovenian: Zdravilo Ultomiris je potrebno razredčiti do končne koncentracije 5 mg/ml.
English: Pyrexia, Influenza like illness, Fatigue, Chills, Asthenia
Slovenian: • zvišana telesna temperatura (pireksija), gripi podobna bolezen, mrzlica, občutek utrujenosti
English: What is Ultomiris
Slovenian: Kaj je zdravilo Ultomiris
English: NAME OF THE MEDICINAL PRODUCT Ultomiris 300 mg concentrate for solution for infusion
Slovenian: IME ZDRAVILA Ultomiris 300 mg koncentrat za raztopino za infundiranje
English: o No clinical data on exposed pregnancies is available.
Slovenian: o obstaja tveganje za nastanek protiteles proti ravulizumabu; o klinični podatki o izpostavljenih nosečnostih niso na voljo.
English: ANNEX I
Slovenian: Kategorija b
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ultomiris 300 mg concentrate for solution for infusion.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ultomiris 300 mg koncentrat za raztopino za infundiranje ravulizumab
English: Loading dose (mg)
Slovenian: Polnilni odmerek (mg)
English: The product should be mixed gently.
Slovenian: Zdravilo rahlo premešajte.
English: Table 2: Maintenance dose administration reference table
Slovenian: Preglednica 2: Referenčna preglednica za dajanje vzdrževalnih odmerkov
English: Do not administer as an intravenous push or bolus injection.
Slovenian: Zdravila ne smete dajati z intravensko hitro ali bolusno injekcijo.
English: ravulizumab
Slovenian: Odmerjanje
English: Cases of serious or fatal meningococcal infections/sepsis have been reported in patients treated with other terminal complement inhibitors.
Slovenian: Pri bolnikih, zdravljenih z drugimi inhibitorji terminalnega komplementa, so poročali o primerih resnih ali smrtnih meningokoknih okužb/sepse.
English: What is Ultomiris used for
Slovenian: Za kaj zdravilo Ultomiris uporabljamo
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride
Slovenian: 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat dihidrat dinatrijev fosfat dihidrat natrijev klorid polisorbat 80 voda za injekcije
English: Eculizumab (N = 98)
Slovenian: Ekulizumab (N = 98)
English: o The need to explain to and ensure understanding of by patients: o the risk of treatment with ravulizumab (including potential risks of serious infections and malignancies and haematologic abnormalities) o the signs and symptoms of meningococcal infection and what action to take o the patient's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with ravulizumab o the requirement for pre-treatment vaccinations/antibiotic prophylaxis o the enrolment in the PNH registry o Details of the PNH registry and how to enter patients
Slovenian: Dojenje je treba prekiniti med zdravljenjem in do osem mesecev po zdravljenju; o tveganje za resno hemolizo po prekinitvi zdravljenja z ravulizumabom in odlogu dajanja zdravila, kriterije zanjo, zahtevano spremljanje po zdravljenju in predlagano zdravljenje; o bolnikom je treba razložiti in se prepričati, da razumejo naslednje: o tveganje zdravljenja z ravulizumabom (vključno z možnimi tveganji resnih okužb in malignih bolezni ter hematoloških nepravilnosti); o znake in simptome meningokokne okužbe in kaj morajo storiti v takem primeru; o vodnik za bolnike in njegovo vsebino; o opozorilno kartico za bolnika morajo imeti vedno pri sebi in vse zdravstvene delavce, ki sodelujejo pri njihovem zdravljenju, morajo opozoriti, da se zdravijo z ravulizumabom; o zahtevo po cepljenjih/antibiotični profilaksi pred zdravljenjem; o vključitev v register bolnikov s PNH.
English: • The patient guide shall contain the following key messages: o To address the risks of meningococcal infection, serious haemolysis after drug discontinuation in PNH patients, immunogenicity, serious infections, malignancies and haematological abnormalities, use in pregnant and breast-feeding women.
Slovenian: • Vodnik za bolnika mora vsebovati naslednja ključna sporočila: o razložiti tveganja meningokokne okužbe, resne hemolize po prekinitvi zdravljenja pri bolnikih s PNH, imunogenosti, resnih okužb, malignih bolezni in hematoloških nepravilnosti, uporabe pri nosečnicah ali ženskah, ki dojijo; o zdravljenje z ravulizumabom zveča tveganje za okužbe z bakterijo N. meningitidis; o znaki in simptomi meningokokne okužbe in potreba po nujni medicinski pomoči; o opozorilno kartico za bolnika mora imeti bolnik ves čas pri sebi.
English: Refer to the administration reference tables below.
Slovenian: Glejte referenčni preglednici za uporabo v nadaljevanju.
English: After dilution, the final concentration of the solution to be infused is 5 mg/mL.
Slovenian: Po redčenju je končna koncentracija raztopine za infundiranje 5 mg/ml.
English: Haematuria or haemoglobinuria Aplastic anaemia Renal failure
Slovenian: anemija hematurija ali hemoglobinurija aplastična anemija odpoved ledvic mielodisplastični sindrom komplikacija nosečnosti drugo a a
English: Rash, Pruritus
Slovenian: V korist ravulizumabu
English: Pregnancy/ Breast-feeding
Slovenian: Nosečnost/dojenje
English: Study in complement-inhibitor naïve patients with PNH
Slovenian: Študija pri bolnikih s PNH, ki se še niso zdravili z inhibitorjem komplementa
English: What Ultomiris contains
Slovenian: Kaj vsebuje zdravilo Ultomiris
English: Table 1: Loading dose administration reference table
Slovenian: Preglednica 1: Referenčna preglednica za dajanje polnilnega odmerka
English: Ensure that your current meningococcal vaccination is up to date.
Slovenian: Prepričajte se, da ste cepljeni proti meningokokom skladno s programom cepljenja.
English: How to store Ultomiris
Slovenian: Shranjevanje zdravila Ultomiris
English: Ravulizumab has not been studied in patients with PNH who weigh less than 40 kg.
Slovenian: Pri bolnikih s PNH in telesno maso manj kot 40 kg uporabe ravulizumaba niso raziskovali.
English: Cases of serious meningococcal infections/sepsis have been reported in patients treated with ravulizumab.
Slovenian: Pri bolnikih, zdravljenih z ravulizumabom, so poročali o primerih resnih meningokoknih okužb/sepse.
English: Back pain, Arthralgia, Myalgia, Muscle spasms
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v križu, artralgija, mialgija, mišični spazmi
English: • The Guide for healthcare professionals shall contain the following key elements: o To address the risks of meningococcal infection, serious haemolysis after drug discontinuation in PNH patients, immunogenicity, serious infections, malignancies and haematological abnormalities, use in pregnant and breast-feeding women.
Slovenian: • Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente: o razložiti tveganja meningokokne okužbe, resne hemolize po prekinitvi zdravljenja pri bolnikih s PNH, imunogenosti, resnih okužb, malignih bolezni in hematoloških nepravilnosti, uporabe pri nosečnicah ali ženskah, ki dojijo; o zdravljenje z ravulizumabom zveča tveganje za okužbe z bakterijo N. meningitidis; o vse bolnike je treba spremljati za znake meningitisa; o bolnike je treba dva tedna pred prejemom ravulizumaba cepiti proti bakteriji N. meningitidis in/ali morajo prejeti ustrezno antibiotično profilakso; o tveganje za razvoj imunogenosti, zato se svetuje spremljanje bolnikov po infundiranju zdravila;
English: Age (years) at first infusion in study
Slovenian: Starost (leta) ob prvi infuziji v študiji povprečje (SD) mediana min, maks
English: The diluted solution of Ultomiris should be administered by intravenous infusion over approximately 2 hours using a syringe-type pump or an infusion pump.
Slovenian: 2 uri, s pomočjo brizgalne črpalke ali infuzijske črpalke.
English: Anaemia
Slovenian: omotica
English: Meningococcal infections in patients treated with ravulizumab presented as meningococcal sepsis.
Slovenian: Meningokokne okužbe pri bolnikih, zdravljenih z ravulizumabom, so se začele s klinično sliko meningokokne sepse.
English: Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.
Slovenian: Zdravilo Ultomiris smete razredčiti samo z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: Dilution should only use sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent.
Slovenian: Kot vehikel za redčenje smemo uporabljati samo 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single use Type I glass vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Table 1:
Slovenian: NN:
English: If you have meningococcal infection.
Slovenian: Simptomi meningokokne okužbe
English: The safety and efficacy of ravulizumab in patients with PNH were assessed in two open-label, randomised, active-controlled Phase 3 trials: a complement-inhibitor naïve study in adult patients with PNH who were naïve to complement inhibitor treatment, an eculizumab -experienced study in patients with PNH who were clinically stable after having been treated with eculizumab for at least the previous 6 months.
Slovenian: Varnost in učinkovitost ravulizumaba pri bolnikih s PNH so preučevali v dveh odprtih, randomiziranih, aktivno nadzorovanih preskušanjih 3. faze:
English: o Risk of severe haemolysis following discontinuation/postponement of ravulizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing ravulizumab administrations o Potential risks of severe, non-neisserial infections and malignancies and haematologic abnormalities in PNH patients treated with ravulizumab.
Slovenian: o možna tveganja hudih okužb, ki jih ne povzroča Neisseria, malignih bolezni in hematoloških nepravilnosti pri bolnikih s PNH, zdravljenih z ravulizumabom; o vključitev v register bolnikov s PNH.
English: Gastrointestinal disorders
Slovenian: Sprememba v rezultatu testa FACIT-utrujenost
English: Therefore, effective contraception during treatment and up to 8 months after treatment should be used in women who are able to get pregnant.
Slovenian: Zato morajo ženske, ki bi lahko zanosile, uporabljati zanesljivo kontracepcijo med zdravljenjem in do 8 mesecev po končanem zdravljenju.
English: Chest pain, or angina,
Slovenian: • izpuščaj, srbenje kože (pruritus),
English: Dilute Ultomiris to a final concentration of 5 mg/mL (initial concentration divided by 2) by adding the appropriate amount of sodium chloride 9 mg/mL (0.9%) solution for injection to the infusion as per the instructions provided in table below.
Slovenian: 2), tako da infuziji dodate ustrezno količino raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje v skladu z navodili v preglednici v nadaljevanju.
English: Do not use if there is evidence of particulate matter or precipitation.
Slovenian: Če vidite znake vidnih delcev ali oborine, raztopine ne uporabite.
English: Biotransformation and elimination
Slovenian: Spremembe rezultata FACITutrujenost
English: A significant fall in your red blood cell counts (anaemia), Confusion or change in how alert you are,
Slovenian: Tveganja prenehanja uporabe zdravila Ultomiris vključujejo povečano propadanje vaših rdečih krvnih celic, kar lahko povzroči: pomembno zmanjšanje števila rdečih krvnih celic (anemija), zmedenost ali spremembo vaše pozornosti, bolečino v prsnem košu ali angino, zvišanje ravni serumskega kreatinina (težave z ledvicami), ali trombozo (strjevanje krvi).
English: Adverse reactions MedDRA System Organ Class
Slovenian: Preglednica 1: Shema odmerjanja ravulizumaba na podlagi telesne mase
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Slovenian: * Inaktivirani sevi Leptospire : - serološka skupina L. interrogans serovar Canicola Portland-vere 3550-7100 E1 (sev Ca-12-000) - serološka skupina L. interrogans Icterohaemorrhagiae serovar 290-1000 E1 Copenhageni (sev Ic-02-001) - serološka skupina L. interrogans Australis serovar Bratislava 500-1700 E1 (sev AS-05-073) - serološka skupina L. kirschneri Grippotyphosa serovar Dadas 650-1300 E1 (sev Gr-01-005) 1 ELISA enote mase antigena
English: Invented Name
Slovenian: EU številka Izmišljeno ime Jakost
English: In children over one year old:
Slovenian: Pri otrocih, starih več kot eno leto:
English: The initial volume of distribution is about 9 to 12 liters.
Slovenian: Začetni volumen porazdelitve je približno 9 do 12 litrov.
English: You should specifically tell your doctor if you take:
Slovenian: Posebej obvestite svojega zdravnika, če jemljete:
English: Talk to a doctor or pharmacist immediately.
Slovenian: Takoj se pogovorite z zdravnikom ali s farmacevtom.
English: The foregoing presumes that the underlying disease state does not of itself modify the various elements in this profile.
Slovenian: Zgoraj navedeno predpostavlja, da osnovna bolezen sama po sebi ne spremeni različnih elementov tega profila.
English: Serum creatinine μmol/l mg/10 ml
Slovenian: serumski kreatinin μmol/l mg/10 ml
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLL}> <{mesec LLLL}>
English: Contents of the pack and other information
Slovenian: Vsebina pakiranja in druge informacije
English: • Intravenous injections should be given very slowly
Slovenian: • intravenske injekcije je treba dajati zelo počasi;
English: Management of overdose should be supportive.
Slovenian: Zdravljenje prevelikega odmerjanja mora biti podporno.
English: - Menorrhagia and metrorrhagia,
Slovenian: - menoragija in metroragija,
English: Tranexamic acid should be used throughout pregnancy only if the expected benefit justifies the potential risk.
Slovenian: Med nosečnostjo traneksaminsko kislino uporabljamo le, če pričakovana korist opravičuje potencialno tveganje.
English: Urinary excretion via glomerular filtration is the main route of elimination.
Slovenian: Izločanje z urinom preko glomerulne filtracije je glavna pot izločanja.
English: 120 to 249
Slovenian: 120 do 249
English: Women of childbearing potential have to use effective contraception during treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
English: Simultaneous treatment with anticoagulants must take place under the strict supervision of a physician experienced in this field.
Slovenian: Hkratno zdravljenje z antikoagulanti mora potekati pod strogim nadzorom zdravnika z izkušnjami na tem področju.
English: Currently available data are limited and are described in section 5.1.
Slovenian: Trenutno razpoložljivih podatkov je malo in so opisani v poglavju
English: - If you have any further questions, ask your doctor or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
English: However, data on efficacy, posology and safety for these indications are limited.
Slovenian: Podatkov o učinkovitosti, odmerjanju in varnosti pri teh indikacijah je malo.
English: Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not know (can not be estimated from the available data).
Slovenian: Pogostnost je definirana kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do <1/10), občasni (≥ 1/1, 000 do <1/100), ni znano (iz razpoložljivih podatkov pogostnosti ni mogoče oceniti).
English: • malaise with hypotension (low blood pressure), especially if the injection is given too quickly
Slovenian: - slabo počutje s hipotenzijo (nizkim krvnim tlakom) - zlasti, če je injekcija dana prehitro
English: Before use of TXA, risk factors of thromboembolic disease should be considered.
Slovenian: Pred uporabo TXA treba razmisliti o dejavnikih tveganja za trombembolične bolezni.
English: Prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year.
Slovenian: Preprečevanje in zdravljenje krvavitev zaradi splošne ali lokalne fibrinolize pri odraslih in otrocih od enega leta starosti.
English: Pharmacotherapeutic group: Antihemorrhagics, Antifibrinolytics ATC code: B02AA02
Slovenian: Farmakoterapevtska skupina: antihemoragiki, antifibrinolitiki Oznaka ATC: B02AA02
English: • effects on the immune system : allergic reactions
Slovenian: - učinki na imunski sistem: alergijske reakcije
English: Your doctor will decide the correct dose for the child and how long he/she should take it.
Slovenian: Vaš zdravnik se bo odločil o ustreznem odmerku za otroka in kako dolgo ga mora otrok jemati.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: 250 to 500
Slovenian: 250 do 500
English: Therefore, breastfeeding is not recommended.
Slovenian: Dojenje zato ni priporočljivo.
English: Specific indications include: - Haemorrhage caused by general or local fibrinolysis such as:
Slovenian: Posebne indikacije so: - krvavitve zaradi splošne ali lokalne fibrinolize, kot so:
English: Studied population was heterogenic in terms of age, surgery types, dosing schedules.
Slovenian: Populacija v študijah je bila heterogena glede starosti, vrste kirurškega posega, režima odmerjanja.
English: Renal clearance is equal to plasma clearance (110 to 116 mL/min).
Slovenian: Ledvični očistek je enak plazemskemu očistku (110 do 116 ml / min).
English: With the use of the recommended lower doses of TXA, the incidence of post-operative seizures was the same as that in untreated patients.
Slovenian: Pri uporabi priporočenih nižjih odmerkov TXA je bila incidenca po-operativnih napadov enaka kot pri nezdravljenih bolnikih.
English: Signs and symptoms may include dizziness, headache, hypotension, and convulsions.
Slovenian: Znaki in simptomi lahko vključujejo omotico, glavobol, hipotenzijo in konvulzije.
English: Your doctor will decide the correct dose for you and how long you should take it.
Slovenian: Zdravnik bo določil, kakšen odmerek potrebujete in kako dolgo ga morate jemati.
English: Elimination half-life of tranexamic acid is approximately 3 hours
Slovenian: Razpolovna doba traneksaminske kisline je približno 3 ure.
English: Tranexamic acid does not bind to serum albumin.
Slovenian: Traneksaminska kislina se ne veže na serumski albumin.
English: Other medicines and <Tranexamic acid - containing medicinal products> Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, vitamins, minerals, herbal medicines or dietary supplements.
Slovenian: Druga zdravila in <zdravila, ki vsebujejo traneksaminsko kislino> Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta, -vitamine, minerale, zeliščna zdravila ali prehranska dopolnila.
English: • are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • ste alergični na traneksaminsko kislino ali katero koli drugo sestavino tega zdravila (navedenenov poglavju 6);
English: It is excreted mainly in the urineas unchanged drug.
Slovenian: Večinoma se izloča v urinu kot nespremenjeno zdravilo.
English: There is insufficient clinical data on the use of tranexamic acid in pregnant women.
Slovenian: Ni dovolj kliničnih podatkov o uporabi traneksaminske kisline pri nosečnicah.
English: 2.82 to 5.65
Slovenian: 2,82 do 5,65
English: Not know (frequency cannot be estimated from the available data)
Slovenian: Drugi neželeni učinki (iz razpoložljivih podatkov njihove pogostnosti ni mogoče oceniti)
English: • oral contraceptives
Slovenian: • peroralne kontraceptive.