FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor if you suffer from inflammatory diseases of the guts such as Crohn's disease or ulcerative colitis as Constella is not recommended in these patients.
Slovenian: Če se pojavi vnetna bolezen črevesja, kot je Crohnova bolezen ali ulcerozni kolitis, se posvetujte z zdravnikom, saj uporaba zdravila Constella pri teh boleznih ni priporočljiva.
English: Propylene glycol Concentrated ammonia solution Potassium hydroxide Titanium dioxide (E 171) Black iron oxide (E172)
Slovenian: Črnilo kapsule šelak propilenglikol koncentrirana raztopina amoniaka kalijev hidroksid titanov dioksid (E171) črni železov oksid (E172)
English: EU/1/12/801/001 10 capsules
Slovenian: EU/1/12/801/001 10 kapsul
English: The most likely effect of taking too much Constella is diarrhoea.
Slovenian: Če ste uporabili večji odmerek zdravila Constella, kot bi smeli Najverjetnejši učinek prevelikega odmerka zdravila Constella je driska.
English: EU/1/12/801/002 28 capsules
Slovenian: EU/1/12/801/002 28 kapsul
English: Shellac
Slovenian: Placebo
English: For the 26 weeks data, study 1 shows that 37% and 54% of the patients treated with linaclotide compared with 17% and 36% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and abdominal pain/discomfort (p<0.0001) respectively.
Slovenian: Podatki za 26 tednov v študiji 1 so pokazali, da je je odziv olajšanja sindroma razdražljivega črevesja doseglo 37 % bolnikov, zdravljenih z linaklotidom, v primerjavi s 17 % bolnikov, zdravljenih s placebom (p < 0,0001), odziv olajšanja abdominalne bolečine/nelagodja pa je doseglo 54 % bolnikov, zdravljenih z linaklotidom, v primerjavi s 36 % bolnikov, zdravljenih s placebom (p < 0,0001).
English: Tabulated list of adverse reactions
Slovenian: Povzetek neželenih reakcij v obliki preglednice
English: Contact your doctor or pharmacist if you have taken too much of this medicine.
Slovenian: Druga zdravila in zdravilo Constella Obvestite svojega zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Gastroenteritis viral
Slovenian: Infekcijske in parazitske bolezni virusni gastroenteritis
English: Uncommon side effects (may affect up to 1 in 100 people):
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: Talk to your doctor if you experience bleeding from the bowel or rectum.
Slovenian: Če začnete krvaveti iz črevesja ali danke, se posvetujte z zdravnikom.
English: - Medicines that need careful and exact dosing, such as levothyroxine (a hormone to treat reduced function of the thyroid gland).
Slovenian: Glejte navodila v navodilih za uporabo kontracepcijskih tablet, ki jih jemljete; - zdravila, ki zahtevajo skrbno in natančno odmerjanje, kot je levotiroksin (hormon za zdravljenje zmanjšanega delovanja ščitnice).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/801/005 Multipack: 112 (4 packs of 28) capsules 13.
Slovenian: EU/1/12/801/005 112 Veliko pakiranje: 112 (4 pakiranja po 28) kapsul
English: Other medicines and Constella
Slovenian: Shranjevanje zdravila Constella
English: Blood bicarbonate decreased
Slovenian: Preiskave znižane ravni hidrogen karbonata v krvi
English: Study 2 shows that 37% of the patients treated with linaclotide compared with 19% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 55% of the patients treated with linaclotide compared with 42% of the patients treated with placebo showed response to abdominal pain/discomfort (p=0.0002).
Slovenian: V študiji 2 je bila stopnja odziva olajšanja sindrom razdražljivega črevesja dosežena pri 37 % bolnikov, zdravljenih z linaklotidom, v primerjavi z 19 % bolnikov, zdravljenih s placebom (p < 0,0001), odziv olajšanja abdominalne
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 290 micrograms of linaclotide
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 290 mikrogramov linaklotida.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
Slovenian: Izgled zdravila Constella in vsebina pakiranja
English: The main symptoms of IBS with constipation include:
Slovenian: Glavni simptomi razdražljivega črevesja z zaprtjem vključujejo: bolečino v želodcu ali trebuhu občutek napenjanja
English: Lactation
Slovenian: • slabost
English: MA (EU) number (Invented) name
Slovenian: Številka(e) postopka EMEA
English: --1 Live aroA gene deleted Escherichia coli, type O78, strain EC34195 - 5.2x106 - 9.1x108 CFU* * Colony forming units when grown on tryptic soy agar plates.
Slovenian: --1 Živa Escherichia coli, tip O78 z delecijo gena aroA, sev EC34195 - 5,2 x 106 do 9,1 x 108 CFU *CFU - Colony Forming Unit - kolonijske enote pri rasti na triptičnem soja agarju
English: Invented name
Slovenian: Izmišlj eno ime
English: EU (MA) number
Slovenian: EU številka(e) dovoljenj(a) za promet
English: Strength Pharmaceutical form Target species
Slovenian: Ciljna živalska vrsta
English: 12 (3 x 4) pre-filled syringes (multipack)
Slovenian: 12 (3 x 4) napolnjeni injekcijski peresniki (skupno pakiranje)
English: 4 pre-filled pens
Slovenian: 4 napolnjeni injekcijski peresniki
English: In some cases the bleeding may not be obvious.
Slovenian: V nekaterih primerih krvavitev mogoče ni očitna.
English: The first event of each category is included in the analysis.
Slovenian: Prvi dogodek v vsaki kategoriji je vključen v analizo.
English: The formula is as follows:
Slovenian: Formula je naslednja:
English: 5 years
Slovenian: 5 leta
English: 0.004 (for superiority)
Slovenian: 0,004 (za superiornost)
English: Please keep this card with you at all times.
Slovenian: To kartico imejte vedno pri sebi.
English: The absolute bioavailability is approximately 62%.
Slovenian: Absolutna biorazpoložljivost je približno 62 %.
English: Date of birth:
Slovenian: Datum rojstva:
English: • Use of coagulation tests and their interpretation
Slovenian: • uporaba koagulacijskih testov in njihova interpretacija;
English: Your doctor may change your anticoagulant treatment as follows:
Slovenian: Vaš zdravnik lahko spremeni vaše antikoagulantno zdravljenje takole:
English: Steady state concentrations are achieved within 3 days.
Slovenian: Koncentracija v stanju ravnovesja se doseže v 3 dneh.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2017
Slovenian: Datum prve odobritve: 20. april 2017
English: WHEN TO SEEK MEDICAL ADVICE
Slovenian: KDAJ JE TREBA POISKATI ZDRAVNIŠKI NASVET?
English: Ethnic origin
Slovenian: Etnični izvor
English: Recombinant factor VIIa (r-FVIIa) can also be considered.
Slovenian: V poštev lahko pride tudi rekombinantni faktor VIIa (r-FVIIa).
English: The Prescriber Guide for healthcare professionals shall contain the following key elements:
Slovenian: Smernice za predpisovanje za zdravstvene delavce morajo vsebovati naslednje ključne elemente:
English: It is therefore important to be aware of the possible signs and symptoms of bleeding and to speak to your doctor immediately if you experience any of the following:
Slovenian: Zato je pomembno, da poznate morebitne znake in simptome krvavitve in da se takoj pogovorite z zdravnikom, če opazite kar koli od naslednjega:
English: These medicinal products should not be administered simultaneously.
Slovenian: Ta zdravila se ne smejo uporabljati sočasno.
English: In case of clinically significant bleeding, stop treatment immediately.
Slovenian: V primeru klinično pomembne krvavitve takoj prenehajte z zdravljenjem.
English: - if you have a mechanical heart valve
Slovenian: - če imate mehanično srčno zaklopko.
English: Superiority testing was performed on the ITT Overall Study Period.
Slovenian: Preskus superiornosti so opravili na skupini ITT celotno obdobje študije.
English: If you need to have an operation:
Slovenian: Če je pri vas potreben kirurški poseg:
English: Food increases peak exposure to a varying extent, but has minimal effect on total exposure.
Slovenian: Hrana zvečuje največjo izpostavljenost v različnem obsegu, a minimalno vpliva na celotno izpostavljenost.
English: • For creatinine in mg/dL:
Slovenian: • Za kreatinin v mg/dl:
English: Note: A subject can be included in multiple sub-categories if he/she had an event for those categories.
Slovenian: Opomba:Preiskovanka/-ec je lahko zajet v več podkategorijah, če je imel/-a dogodek, ki ustreza tistim kategorijam.
English: 1 Reporting rates are based on the female population in clinical trials.
Slovenian: 1 O pogostnostih so poročali na podlagi populacije žensk v kliničnih preskušanjih.
English: Experience with overdose cases is very limited.
Slovenian: Izkušenj s primeri prevelikega odmerjanja je zelo malo.
English: The treatment duration was from 3 months up to 12 months, determined by the investigator based on the patient's clinical features.
Slovenian: Zdravljenje je trajalo od 3 mesecev do 12 mesecev, trajanje je določil raziskovalec na podlagi bolnikove klinične slike.
English: The t½ for oral administration is 10 - 14 hours.
Slovenian: t½ za peroralno dajanje je 10 - 14 ur.
English: c 'Any Confirmed Bleeding' includes those that the adjudicator defined as clinically overt.
Slovenian: c Kakršna koli potrjena krvavitev zajema tiste, ki jih je potrjevalec opredelil kot klinično očitne.
English: Your doctor may decide to keep you under closer observation or change your medicine.
Slovenian: Zdravnik se lahko odloči, da vas bo natančno opazoval ali vam spremenil zdravilo.
English: The volume of distribution is 107 (19.9) L mean (SD).
Slovenian: Volumen porazdelitve je 107 (19,9) l povprečje (SD).
English: Menstrual bleeding may be intensified and/or prolonged.
Slovenian: Menstrualna krvavitev je lahko močnejša in/ali daljša.
English: Prior to launch of Roteas in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravilaRoteasna trg vsake države članice se mora imetnik dovoljenja za promet z zdravilom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s komunikacijskimi mediji, načini distribucije in vsemi drugimi vidiki programa, s pristojnim nacionalnim organom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemaliali pa boste morda začeli jemati katero koli drugo zdravilo.
English: • Blood found in your urine
Slovenian: • kri, najdena v vašem urinu,
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention:
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti z uporabo naslednjega dogovora:
English: It is important that you take your medication exactly as instructed by your doctor.
Slovenian: Pomembno je, da zdravilo jemljete točno tako, kot vam je naročil zdravnik.
English: TREATMENT INFORMATION (To be completed by physician)
Slovenian: INFORMACIJE O ZDRAVLJENJU (Izpolni zdravnik.)
English: Effect of edoxaban on other medicines
Slovenian: Vpliv edoksabana na druga zdravila
English: ICH non-fatal CRNM Bleeding n
Slovenian: ICH ne-fatalna CRNM krvavitev n
English: Please consult the Summary of Product Characteristics (SmPC) for more information.
Slovenian: Za več informacij glejte Povzetek glavnih značilnosti zdravila (SmPC).
English: • Uncontrolled severe hypertension.
Slovenian: • Neobvladana težka hipertenzija.
English: • Vomiting blood or material that looks like ground coffee
Slovenian: • bruhanje krvi ali snovi, ki je videti kot kavna usedlina,
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.
Slovenian: Odločiti se je treba ali prenehati z dojenjem ali prenehati oz. vzdržati se zdravljenja.
English: PATIENT INFORMATION Patient name:
Slovenian: INFORMACIJE O BOLNIKU Ime bolnika:
English: In case of emergency, please contact: Name:
Slovenian: V nujnem primeru se obrnite na: Ime:
English: What Roteas is and what it is used for 2.
Slovenian: Kaj je zdravilo Roteas in za kaj ga uporabljamo 2.
English: Bleeding can occur at any site and may be severe and even fatal (see section 4.4).
Slovenian: Krvavitev se lahko pojavi kjerkoli in je lahko težka in celo smrtna (glejte poglavje 4.4).
English: Patients with active cancer
Slovenian: Bolniki z aktivnim rakom
English: Most patients (85%) should be able to achieve an INR ≥ 2.0 within 14 days of concomitant administration of Roteas and VKA.
Slovenian: Večina bolnikov (85 %) bi morala biti sposobna doseči INR ≥ 2,0 v 14 dneh sočasnega zdravljenja z zdravilom Roteas in VKA.
English: (mm/yy)
Slovenian: (mm/ll)
English: • recent bleeding in your brain (intracranial or intracerebral bleeding)
Slovenian: • nedavna krvavitev v vaših možganih(intrakranialna ali intracerebralna krvavitev),
English: Patients with antiphospholipid syndrome
Slovenian: Bolniki z antifosfolipidnim sindromom
English: What you need to know before you take Roteas 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Roteas 3.
English: Disposition is biphasic.
Slovenian: Porazdelitev je bifazična.
English: The anticoagulant effect of edoxaban cannot be reliably monitored with standard laboratory testing.
Slovenian: Antikoagulantnega delovanja edoksabana ni mogoče zanesljivo spremljati s standardnimi laboratorijskimi testi.
English: Patients should not take a loading dose of VKA in order to promptly achieve a stable INR between 2 and 3.
Slovenian: Bolniki naj ne vzamejo polnitvenega odmerka VKA, da bi takoj dosegli stabilenINR med 2 in 3.
English: Its active metabolite is a substrate for OATP1B1.
Slovenian: Njegov aktivni presnovek je substrat za OATP1B1.
English: a A subject can be represented in multiple rows.
Slovenian: a Preiskovanec je lahko predstavljen v več vrstah.
English: Roteas 15 mg is not indicated as monotherapy, as it may result in decreased efficacy.
Slovenian: Zdravilo Roteas 15 mg ni indicirano za monoterapijo, saj bi lahko prišlo do zmanjšane učinkovitosti.
English: Subjects were maintained on treatment for 28 days post cardioversion.
Slovenian: Zdravljenje so vzdrževali še 28 dni po kardioverziji.
English: Do not take a double dose on the same day to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka istega dne, da bi nadomestili pozabljeni odmerek.
English: The method used to estimate renal function (CrCL in mL/min) during the clinical development of Roteas was the Cockcroft-Gault method.
Slovenian: Metoda, uporabljena za oceno delovanja ledvic (CrCL v ml/min) med kliničnim razvojem zdravila Roteas,je bila Cockcroft-Gaultova metoda.
English: Blood type: Other medications/conditions:
Slovenian: Krvna skupina: Druga zdravila/zdravstvena stanja:
English: Assessment of renal function:
Slovenian: Ocena delovanja ledvic:
English: p-value < 0.0001 (non-inferiority)
Slovenian: vrednost p < 0,0001 (neinferiornost)
English: Renal function in NVAF
Slovenian: Delovanje ledvic pri NVAF
English: How much to take
Slovenian: Koliko zdravila jemati
English: • Clinically significant active bleeding.
Slovenian: • Klinično pomembna aktivna krvavitev.
English: c The two-sided p-value is based on the non-inferiority margin of 1.38.
Slovenian: c Dvostranska vrednost p temelji na meji neinferiornosti 1,38.
English: However, a calibrated anti-Factor Xa assay may help inform clinical decisions.
Slovenian: Vendar pa lahko kalibrirani test proti faktorju anti-Xa pomaga pri sprejemanju informiranih kliničnih odločitev.
English: 85276 Pfaffenhofen, Bayern Germany
Slovenian: 85276 Pfaffenhofen, Bayern
English: • Pregnancy and breast-feeding (see section 4.6).
Slovenian: • Nosečnost in dojenje (glejte poglavje 4.6).
English: Edoxaban has a half-life of approximately 10 to 14 hours (see section 5.2).
Slovenian: Razpolovni čas edoksabana je približno 10 do 14 ur (glejte poglavje 5.2).
English: • Relevant information on the risk of bleeding
Slovenian: • pomembne informacije o tveganju krvavitev;
English: • Do not start any other medications (including over the counter) without consulting your doctor.
Slovenian: • Pred začetkom jemanja katerega koli drugega zdravila (vključno z zdravili, ki jih dobite brez recepta) se posvetujte z zdravnikom.
English: Efficacy and safety of edoxaban in the treatment and/or prevention of VTE in patients with active cancer have not been established.
Slovenian: Učinkovitosti in varnosti edoksabana v zdravljenju in/ali preprečevanju VTE pri bolnikih z aktivnim rakom niso ugotovili.
English: If you currently take 30 mg (dose reduced) Roteas:
Slovenian: Če trenutno jemljete 30 mg (zmanjšani odmerek)zdravila Roteas:
English: In vitro plasma protein binding is approximately 55%.
Slovenian: Vezava na plazemske beljakovine in vitro je približno 55 %.
English: If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.
Slovenian: Če opazite pri sebi kakšno krvavitev, ki se ne ustavi sama od sebe, ali če opazite znake čezmerne krvavitve (hudo oslabelost, utrujenost, bledico, omotico, glavobolali otekanje brez jasnega vzroka), se nemudoma posvetujte z zdravnikom.
English: • That all patients should be provided with a Patient alert card and be counselled about: The signs or symptoms of bleeding and when to seek attention from a healthcare provider Importance of treatment compliance Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals that they are taking Roteas if they need to have any surgery or invasive procedure
Slovenian: • da morajo vsi bolniki prejeti kartico z opozorili za bolnika in da jim moramo svetovati o: znakih ali simptomih krvavitve in o tem, kdaj je treba poiskati zdravniško pomoč, pomembnosti jemanja zdravila po zdravnikovih navodilih, o potrebi, da imajo kartico z opozorili za bolnika vedno s seboj, o potrebi, da obvestijo zdravstvene delavce, da jemljejo zdravilo Roteas, če je pri njih potrebna kakršna koli operacija ali invaziven poseg.
English: Laboratory coagulation parameters
Slovenian: Laboratorijski koagulacijski parametri
English: • Lesion or condition, if considered to be a significant risk for major bleeding.
Slovenian: • Poškodbe ali stanja, za katere se meni, da predstavljajo pomembno tveganje za velike krvavitve.
English: • Other types of bleeding
Slovenian: • druge vrste krvavitev,
English: • The need to inform Health Care Professionals that they are taking Roteas if they need to have any surgery or invasive procedure
Slovenian: • o potrebi, da obvestijo zdravstvene delavce, da jemljejo zdravilo Roteas, če je pri njih potrebna kakršna koli operacija ali invaziven poseg.
English: In healthy subjects, the total clearance is estimated as 22 (± 3) L/hour; 50% is renally cleared (11 L/hour).
Slovenian: Pri zdravih preiskovancih ocenjujejo celotni očistek na 22 (±3) l/uro; 50 % se očisti skozi ledvice (11 l/uro).
English: If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Roteas.
Slovenian: Če obstaja možnost, da bi lahko zanosili, jemljite zanesljivo kontracepcijsko sredstvo, ko jemljete zdravilo Roteas.
English: Berlin-Chemie [LOGO]
Slovenian: Berlin-Chemie [LOGOTIP]
English: PE with or without DVT Fatal PE or Death where PE cannot be ruled out
Slovenian: PE z GVT ali brez nje smrtni PE ali smrt, pri kateri PE ni mogoče izključiti ne-fatalna PE samo GVT
English: For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Roteas as prescribed.
Slovenian: Za vse bolnike, pri katerih se izvaja kardioverzija: Pred kardioverzijo se je treba prepričati, da je bolnik vzel zdravilo Roteas, kakor je bilo predpisano.
English: If you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Slovenian: Če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil,
English: Vaginal bleeds were reported commonly in women under the age of 50 years, while it was uncommon in women over the age of 50 years.
Slovenian: O vaginalnih krvavitvah so poročali pogosto pri ženskah, mlajših od 50 let, in občasno pri ženskah, starejših od
English: Warfarin (N = 4,122)
Slovenian: Varfarin (N = 4.122)
English: If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Roteas at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body.
Slovenian: Če je vaš nenormalen srčni utrip treba povrniti na normalnega s postopkom, ki mu pravimo kardioverzija, vzemite zdravilo Roteas takrat, kot vam je naročil zdravnik, da preprečite krvne strdke v možganih in krvnih žilah drugod po vašem telesu.
English: The educational programme is aimed at mitigating the risk of serious bleeds or haemorrhage in patients treated with Roteas by ensuring prescriber awareness and providing guidance on appropriate patient selection, correct dosing as well as management of the risk.
Slovenian: Cilj izobraževalnega programa je zmanjševanje tveganja resnih krvavitev pri bolnikih, ki se zdravijo z zdravilom Roteas, in sicer tako, da se zagotovi ozaveščanje zdravnikov, ki predpisujejo zdravilo, in podajanje smernic za ustrezno izbiro bolnikov, pravilno odmerjanje, pa tudi obvladovanje tveganja.
English: • Renal function should also be assessed when a change in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).
Slovenian: • Delovanje ledvic je treba oceniti tudi, če se med zdravljenjem pojavi sum na spremembo v delovanju ledvic (npr.hipovolemija, dehidracija in sočasna uporaba določenih zdravil).
English: Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, the serine protease located in the final common pathway of the coagulation cascade.
Slovenian: Edoksaban je visoko selektiven, direkten in reverzibilen zaviralec faktorja Xa, serinske proteaze, ki je locirana v končni skupni poti koagulacijske kaskade.
English: This recommendation is based on standard treatment of drug overdose and data available with similar compounds, as the use of activated charcoal to reduce absorption of edoxaban has not been specifically studied in the edoxaban clinical programme.
Slovenian: To priporočilo temelji na standardnem zdravljenju prevelikega odmerjanja zdravil in na podatkih o podobnih snoveh, ki so na voljo, ker uporabe aktivnega oglja za zmanjšanje absorpcije edoksabana v kliničnem programu za edoksaban niso posebej raziskovali.
English: c The p-value is for the pre-defined non-inferiority margin of 1.5.
Slovenian: c Vrednost p je za vnaprej določeno mejo neinferiornosti 1,5.
English: Edoxaban is poorly soluble at pH of 6.0 or higher.
Slovenian: Edoksaban je pri pH 6,0 ali višjem pH slabo topen.
English: Roteas can be taken with or without food.
Slovenian: Zdravilo Roteaslahko jemljete s hrano ali brez nje.
English: Do not take Roteas:
Slovenian: Ne jemljite zdravilaRoteas:
English: Any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site.
Slovenian: Vsako nerazloženo zmanjšanje hemoglobina ali znižanje krvnega tlaka mora sprožiti iskanje mesta krvavitve.
English: 30 mg once daily
Slovenian: 30 mg enkrat na dan
English: Subjects with ESRD undergoing peritoneal dialysis had 93% higher total exposure compared with healthy subjects.
Slovenian: Osebe z ESRD na peritonealni dializi so imele v primerjavi z zdravimi osebami za 93 % večjo celotno izpostavljenost.