natgillin/translations-raw huggingface dataset:
Decisions on initiation and duration of treatment should follow established guidelines for anticoagulant treatment in patients undergoing cardioversion.
se je treba pri odločitvah glede uvedbe in trajanja zdravljenja ravnati po uveljavljenih smernicah za zdravljenje z antikoagulanti.
Gender No dose reduction is required (see section 5.2).
Spol Nikakršno zmanjševanje odmerka ni potrebno (glejte poglavje 5.2).
Edoxaban is a substrate for the efflux transporter P-gp.
Edoksaban je substrat za iztočni prenašalec P-gp.
(140-age [years]) × weight [kg] (× 0.85 if female) 72 × serum creatinine [mg/dL]
(140 - starost [v letih]) ×masa [kg] (×0,85 pri ženskah) 72 ×serumski kreatinin [mg/dl]
If you forget to take Roteas
Če ste pozabili vzeti zdravilo Roteas
• Bleeding in the eyes
• krvavitve v očeh,
Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding, as judged to be appropriate.
Poleg ustreznega kliničnega nadzora je za odkrivanje prikritih krvavitev lahko koristno laboratorijsko določanje vrednosti hemoglobina/hematokrita, če se to presodi kot potrebno.
- If your doctor has prescribed medicines known as P-gp inhibitors: ciclosporin, dronedarone,
- Če vam je zdravnik predpisal zdravila, ki so znana pod imenom zaviralci P-gp:ciklosporin,
Edoxaban increased the Cmax of concomitantly administered digoxin by 28%; however, the AUC was not affected.
Edoksaban je zvečal Cmax sočasno danega digoksina za 28 %; vendar pa se AUC ni spremenila.
The risk of bleedings may be increased in certain patient groups e.g. those patients with uncontrolled severe arterial hypertension and/or on concomitant treatment affecting haemostasis (see Haemorrhagic risk in section 4.4).
Tveganje za krvavitve je lahko večje v določenih skupinah bolnikov, npr. pri bolnikih z nenadzorovano hudo arterijsko hipertenzijo in/ali sočasnim zdravljenjem, ki vpliva na hemostazo (glejte poglavje 4.4 Tveganje za krvavitve).
The efficacy results for pre-specified major subgroups (with dose reduction as required), including age, body weight, gender and status of renal function were consistent with the primary efficacy results for the overall population studied in the trial.
Rezultati učinkovitosti za vnaprej določene večje podskupine (po potrebi z zmanjšanjem odmerka), vključno s starostjo, telesno maso, spolom in stanjem funkcije ledvic, so se ujemali s primarnimi rezultati učinkovitosti za celotno populacijo, proučevano v študiji.
The MAH shall ensure that in each Member State where Roteas is marketed, all healthcare professionals who are expected to use Roteas are provided with the following educational material:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, v kateri se bo tržilo zdravilo Roteas, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo
Take special care with Roteas
Bodite posebno pozorni pri jemanju zdravila Roteas
If you take more Roteas than recommended, you may have an increased risk of bleeding.
Če vzamete več zdravila Roteas, kot je priporočeno, imate lahko zvečano tveganje krvavitev.
Secondary efficacy endpoints included: Composite of stroke, SEE, and cardiovascular (CV) mortality; major adverse cardiovascular event (MACE), which is the composite of non-fatal MI, non-fatal stroke, non-fatal SEE, and death due to CV cause or bleeding; composite of stroke, SEE, and all-cause mortality.
Sekundarni kriteriji učinkovitosti so vključevali: kombinacijo možganske kapi, SEE in kardiovaskularne (KV) smrtnosti; pomemben kardiovaskularen neželeni dogodek (MACE), ki je kombinacija ne-smrtnega miokardnega infarkta (MI), ne-smrtne možganske kapi, ne-smrtnih SEE in smrti zaradi KV vzroka ali krvavitve; kombinacijo možganske kapi, SEE in smrtnosti ne glede na vzrok.
Roteas administration should be discontinued if severe haemorrhage occurs (see sections 4.8 and 4.9).
Zdravljenje z zdravilom Roteas je treba prekiniti, če se pojavijo hude krvavitve (glejte poglavji 4.8 in 4.9)
• Bruising or bleeding under the skin
• modrice ali krvavitev pod kožo,
Prevention of stroke and systemic embolism
Preprečevanje možganske kapi in sistemske embolije
These patients are to be carefully monitored for signs and symptoms of bleeding complications and anaemia after initiation of treatment (see section 4.8).
Te bolnike je treba po uvedbi zdravljenja skrbno spremljati glede znakov in simptomov zapletov s krvavitvami in anemije (glejte poglavje 4.8).
For life-threatening bleeding that cannot be controlled with the measures such as transfusion or haemostasis, the administration of a 4-factor prothrombin complex concentrate (PCC) at 50 IU/kg has been shown to reverse the effects of Roteas 30 minutes after completing the infusion.
Pri smrtno nevarni krvavitvi, ki je ne moremo obvladati s transfuzijo ali hemostazo, so pokazali, da uporaba koncentrata protrombinskega kompleksa s 4 faktorji (PCC) v odmerku 50 i.e./kg nevtralizira učinke zdravila Roteas30 minutpo končani infuziji.
Concomitant use of edoxaban with ciclosporin, dronedarone, erythromycin, or ketoconazole requires dose reduction to 30 mg once daily.
Pri sočasni uporabi edoksabana s ciklosporinom, dronedaronom, eritromicinom ali ketokonazolom je potrebno zmanjšanje odmerka na 30 mg enkrat na dan.
Warfarin (N = 7,012)
Varfarin (N = 7.012)
Abbreviations: N = number of subjects; mITT population overall study period; n = number of patients in subgroup *HR not computed if number of events < 5 in one treatment group.
Okrajšave: N = število preiskovancev;populacija mITT celotno obdobje študije; n = število bolnikov v podskupini *HR ni izračunano, če je število dogodkovv eni skupini zdravljenja < 5.
In the comparator arm, subjects received initial heparin therapy concurrently with warfarin, titrated to a target INR of 2.0 to 3.0, followed by warfarin alone.
V kraku s primerjalnim zdravilom so preiskovanci prejemali začetno heparinsko terapijo sočasno z varfarinom, titriranim na ciljno INR 2,0 do 3,0, ki mu je sledil samo varfarin.
Your doctor will determine when to restart Roteas.
Zdravnik bo določil, kdaj boste spet začeli jemati zdravilo Roteas.
Edoxaban vs Warfarin HR (95% CI)b p-valuec
Edoksaban proti varfarinu HR (95 % CI)b vrednost pc
The primary efficacy endpoint was the recurrence of symptomatic VTE, defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE in subjects during the 12-month study period.
Primarni kriterij učinkovitosti je bil recidiv simptomatskega VTE, po definiciji sestavljen iz recidivne simptomatske GVT, ne-fatalnega simptomatskega PE in fatalnega PE pri preiskovancih med
Common other adverse reactions for edoxaban were anaemia, rash and abnormal liver function tests.
Drugi pogosti neželeni učinki pri edoksabanu so bili anemija, izpuščaj in nenormalni testi delovanja jeter.
Edoxaban can be co-administered with low dose ASA (≤ 100 mg/day).
Edoksaban se lahko uporablja sočasno z ASA v majhnih odmerkih (≤ 100 mg/dan).
Discontinuation for surgery and other interventions If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, Roteas should be stopped as soon as possible and preferably at least 24 hours before the procedure.
Če morate antikoagulacijo prekiniti, da se zmanjša nevarnost krvavitve pri kirurških ali drugih postopkih, zdravilo Roteas ukinite, takoj ko je to mogoče, po možnosti pa vsaj 24 ur pred postopkom.
Elderly No dose reduction is required (see section 5.2).
Starejši Nikakršno zmanjševanje odmerka ni potrebno (glejte poglavje 5.2).
If you stop taking Roteas
Če ste prenehali jemati zdravilo Roteas
Present it to your healthcare professional, pharmacist, surgeon or dentist before any medical treatment or intervention.
Pred vsakim zdravljenjem ali medicinskim posegom jo pokažite zdravstvenemu delavcu, farmacevtu, kirurgu ali zobozdravniku.
Table 11: Bleeding Events in Hokusai-VTE Study - Safety Analysis On-Treatment Perioda
Preglednica 11: Krvavitveni dogodki v študiji Hokusai-VTE - analiza varnosti med zdravljenjema
b Primary Safety Endpoint: Clinically relevant bleeding (composite of major and clinically relevant non-major bleeding).
b Primarno končno stanje varnosti: klinično pomembna krvavitev (sestavljena iz velike krvavitve in klinično pomembne krvavitve, ki ni bila velika).
Acetylsalicylic acid (ASA): Co-administration of ASA (100 mg or 325 mg) and edoxaban increased bleeding time relative to either medicine alone.
Acetilsalicilna kislina (ASA): sočasna uporaba ASA (100 mg ali 325 mg) in edoksabana je podaljšala čas krvavitve bolj kot vsako posamezno zdravilo.
In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Zlasti pri trojno pozitivnih bolnikih (za lupusni antikoagulant, protitelesa proti kardiolipinu in protitelesa proti beta 2-glikoproteinu I) je zdravljenje s peroralnimi antikoagulanti z neposrednim delovanjem v primerjavi z zdravljenjem z antagonisti vitamina K lahko povezano s povečano pogostnostjo ponavljajočih se trombotičnih dogodkov.
Changes observed in these clotting tests are expected at the therapeutic dose, however, these changes are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of edoxaban.
Spremembe, ki so jih opazili v teh testih strjevanja, so pri terapevtskem odmerku pričakovane, a majhne, zelo variabilne in niso koristne za spremljanje antikoagulacijskega učinka edoksabana.
Edoxaban inhibits free factor Xa, and prothrombinase activity.
Edoksaban inhibira prosti faktor Xa in aktivnost protrombinaze.
First SEE n (%/yr)a
Prvi SEE n (%/leto)a
• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
• Bolezen jeter, ki je povezana z motnjami strjevanja krvi in s klinično pomembnim tveganjem za krvavitve.
Population PK modeling indicates that exposure approximately doubles in patients with severe renal impairment (CrCL 15 - 29 mL/min) relative to patients with normal renal function.
Populacijsko FK modeliranje kaže, da se v primerjavi z bolniki z normalno funkcijo ledvic izpostavljenost pri bolnikih s hudo okvaro ledvic (CrCL 15 - 29 ml/min) približno podvoji.
Your doctor will decide if you should be treated with Roteas and if you should be kept under observation.
Zdravnik se bo odločil, ali potrebujete zdravljenje z zdravilom Roteas in ali je pri vas potreben nadzor.
100 film-coated tablets 10 x 1 film-coated tablets 50 x 1 film-coated tablets 100 x 1 film-coated tablets
100 filmsko obloženih tablet 10 x 1 filmsko obložena tableta 50 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta
Table 3 provides the list of adverse reactions from the two pivotal Phase 3 studies in patients with VTE (DVT and PE) (Hokusai-VTE study) and AF (ENGAGE AF-TIMI 48 study) combined for both indications.
Preglednica 3 navaja seznam neželenih učinkov iz dveh ključnih študij 3. faze pri bolnikih z VTE (GVT in PE) (študija Hokusai-VTE) in AF (študija ENGAGE AF-TIMI 48), združenih za obe indikaciji.
The safety of edoxaban has been evaluated in two Phase 3 studies including 21,105 patients with NVAF (ENGAGE AF-TIMI 48 study), and 8,292 patients with VTE (DVT and PE) (Hokusai-VTE study).
Varnost edoksabana so ovrednotili v dveh študijah 3. faze, v kateri je bilo vključenih 21.105 bolnikov z NVAF (študija ENGAGE AF-TIMI 48) in 8.292 bolnikov z VTE (GVT in PE) (študija HokusaiVTE).
What you need to know before you take Roteas
Kaj morate vedeti, preden boste vzeli zdraviloRoteas
Treatment of DVT, treatment of PE and the prevention of recurrent DVT and PE (VTE) The edoxaban clinical programme for VTE was designed to demonstrate the efficacy and safety of edoxaban in the treatment of DVT and PE, and the prevention of recurrent DVT and PE.
Zdravljenje GVT, zdravljenje PE in preprečevanje recidivnih GVT in PE (VTE) Klinični program edoksabana za vensko trombembolijo (VTE) je bil zasnovan tako, da bi prikazal učinkovitost in varnost edoksabana za zdravljenje GVT in PE in za preprečevanje recidivnih GVT in
The primary efficacy outcome consisted of a composite of all stroke, SEE, MI and CV mortality.
Primarni izid učinkovitosti je bil kompozit celotne umrljivosti zaradi možganske kapi, SEE, MI in CV.
Edoxaban is a substrate for the efflux transporter P-glycoprotein (P-gp), but not a substrate for uptake transporters such as organic anion transporter polypeptide OATP1B1, organic anion transporters OAT1 or OAT3 or organic cation transporter OCT2.
Izpostavljenost drugim presnovkom je manj kot 5 %.Edoksaban je substrat za iztočni prenašalec P-glikoprotein (P-gp), ni pa substrat za privzemne prenašalce, na primer za polipeptidni prenašalec organskih anionov OATP1B1, prenašalca organskih anionov OAT1 in OAT3 ali prenašalec organskih kationov OCT2.
Patients undergoing cardioversion:
Bolniki, pri katerih se izvaja kardioverzija:
Edoxaban had no effect on the Cmax and AUC of quinidine.
Edoksaban ni vplival na Cmax in AUC kinidina.
Based on these data, when switching from these anticoagulants to edoxaban, the first dose of edoxaban can be initiated at the time of the next scheduled dose of the previous anticoagulant (see section 4.2).
Kadar bolnik prehaja s teh antikoagulantov na edoksaban, na podlagi teh podatkov lahko damo prvi odmerek edoksabana ob času naslednjega načrtovanega odmerka prejšnjega antikoagulanta (glejte poglavje 4.2).
The use of Roteas with other P-gp inhibitors including HIV protease inhibitors has not been studied.
Uporabe zdravila Roteas z drugimi inhibitorji P-gp, vključno z inhibitorji proteaze HIV, niso proučevali.
The efficacy results for pre-specified major subgroups (with dose reduction as required), including age, body weight, gender, status of renal function, prior stroke or TIA, diabetes and P-gp inhibitors were generally consistent with the primary efficacy results for the overall population studied in the trial.
Rezultati učinkovitosti za vnaprej določene pomembne podskupine (po potrebi z zmanjšanjem odmerka), vključno s starostjo, telesno maso, spolom, stanjem funkcije ledvic, predhodno možgansko kapjo ali TIA, s sladkorno boleznijo in z inhibitorji P-gp, so se na splošno ujemali z rezultati primarne učinkovitosti za celotno populacijo, ki so jo proučevali v študiji.
Other medicines and Roteas
Druga zdravila in zdraviloRoteas
• problems with the blood vessels in your brain or spinal column
• težave s krvnimi žilami v vaših možganih ali hrbtenjači.
Do not stop taking Roteas without talking to your doctor first, because Roteas treats and prevents serious conditions.
Ne prenehajte jemati zdravila Roteas, ne da bi se prej posvetovali z zdravnikom, ker zdravilo Roteas zdravi in preprečuje resne bolezni.
b The event rate (%/yr) is calculated as number of events/subject-year exposure.
b Pogostnost dogodka (%/leto) je izračunana kot število dogodkov/izpostavljenost preiskovanec/leto.
It is only indicated in the process of switching from Roteas 30 mg (patients with one or more clinical factors for increased exposure; see table 1) to VKA, together with an appropriate VKA dose (see table 2, section
Indicirano je le v postopku prehoda z zdravila Roteas 30 mg (bolniki z enim ali več kliničnimi dejavniki za zvečano izpostavljenost; glejte preglednico 1) na VKA, v kombinaciji z ustreznim odmerkom VKA (glejte preglednico 2, poglavje 4.2).
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of edoxaban.
Ni pričakovati, da bi protaminijev sulfat in vitamin K vplivala na antikoagulacijskiučinek edoksabana.
What Roteas looks like and contents of the pack
Izgled zdravila Roteasin vsebina pakiranja
In ENGAGE AF-TIMI 48 study in NVAF, efficacy and safety results were similar for subjects with and without concomitant amiodarone use.
Tega niso imeli za klinično pomembno.V študiji ENGAGE AF-TIMI 48 pri NVAF so bili rezultati učinkovitosti in varnosti podobni pri preiskovancih s sočasno uporabo amiodarona in pri tistih brez nje.
Although treatment with edoxaban does not require routine monitoring, the effect on anticoagulation can be estimated by a calibrated quantitative anti-Factor Xa assay which may be useful in exceptional situations where knowledge of edoxaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery (see also section 4.4).
Čeprav zdravljenje z edoksabanom ne zahteva rutinskega spremljanja, je vpliv na antikoagulacijo mogoče oceniti s kalibriranim kvantitativnim testom anti-Xa, ki je lahko uporaben v izjemnih situacijah, kjer bi lahko poznavanje izpostavljenosti edoksabanu pomagalo pri sprejemanju kliničnih odločitev, npr. pri prevelikem odmerjanju in nujnih kirurških posegih (glejte tudi poglavje 4.4).
The pharmacodynamic effects measured by anti-factor Xa assay are predictable and correlate with the dose and the concentration of edoxaban.
Farmakodinamični učinki, merjeni s testom za anti-faktor Xa, so predvidljivi in sorazmerni odmerku in koncentraciji edoksabana.
• some medicines for treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
• zdravila za zdravljenje epilepsije (npr. fenitoin, karbamazepin, fenobarbital),
The primary safety endpoint was clinically relevant bleeding (major or clinically relevant non-major).
Primarno končno stanje varnosti je bila klinično pomembna krvavitev (velika ali klinično pomembna,
No specific studies with edoxaban in humans have been conducted to evaluate effects on fertility.
Posebnih študij o vplivu edoksabana na plodnost pri ljudeh niso opravili.
ICH fatal
ICH smrtna
Oral option: For patients currently on a 60 mg dose, administer a Roteas dose of 30 mg once daily together with an appropriate VKA dose.
Peroralna opcija: bolnikom, ki trenutno prejemajo 60-miligramski odmerek, dajte 30-miligramski odmerek zdravila Roteas enkrat na dan skupaj z ustreznim odmerkom VKA.
Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that edoxaban passes the placenta, Roteas is contraindicated during pregnancy (see section 4.3).
Zaradi možnega vpliva na sposobnost razmnoževanja, tveganja za krvavitve in dokazov, da edoksaban prehaja skozi placento, je uporaba zdravilaRoteasmed nosečnostjo kontraindicirana (glejte poglavje 4.3).
The use of edoxaban with other P-gp inhibitors including HIV protease inhibitors has not been studied.
Uporabe edoksabana z drugimi inhibitorji P-gp, tudi z inhibitorji proteaze HIV, niso proučevali.
How to take the tablet Swallow the tablet, preferably with water.
Tableto pogoltnite po možnosti z vodo.
- prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
Zdravilo Roteasse pri odraslih uporablja: - za preprečevanje nastanka krvnih strdkov v možganih(možganska kap)in drugih krvnih žilah telesa,čeimajo obliko nerednega srčnega ritma, ki se imenuje nevalvularna atrijska fibrilacija, in vsaj še en dodaten dejavnik tveganja.
In the pivotal Hokusai-VTE study, 8,292 subjects were randomised to receive initial heparin therapy (enoxaparin or unfractionated heparin) followed by edoxaban 60 mg once daily or the comparator.
V ključni študiji Hokusai-VTE je bilo 8.292 preiskovancev randomiziranih na prejemanje začetne terapije s heparinom (enoksaparin ali nefrakcioniran heparin), ki mu je sledil edoksaban 60 mg enkrat na dan ali primerjalno zdravilo.
As a result of FXa inhibition, edoxaban also prolongs clotting time in tests such as prothrombin time (PT), and activated partial thromboplastin time (aPTT).
Zaradi inhibicije FXa edoksaban tudi podaljšuje čas strjevanja v testih, kakršna sta na primer protrombinski čas (PT) in aktivirani delni tromboplastinski čas (aPTT).
Adverse reactions were experienced by 2,256 (32.2%) of the patients treated with edoxaban 60 mg (30 mg dose reduced) in the ENGAGE AF-TIMI 48 study and 1,249 (30.3%) in the Hokusai-VTE study.
Neželene učinke je opazilo 2.256 (32,2 %) bolnikov, zdravljenih z edoksabanom 60 mg (zmanjšani odmerek 30 mg) v študiji ENGAGE AF-TIMI 48 in 1.249 (30,3 %) v študiji Hokusai-VTE.
Roteas 60 mg once daily is recommended during concomitant use with the following P-gp inhibitors:
Zdravilo Roteas 60 mg enkrat na dan priporočajo med sočasno uporabo naslednjih inhibitorjev P-gp:
Edoxaban Anti-FXa activity post-dose (IU/mL)1
Aktivnost edoksabana proti faktorju Xa po odmerku (IE/ml)1
Discontinue dabigatran, rivaroxaban or apixaban and start Roteas at the time of the next dose of the oral anticoagulant (see section 5.1).
Ukinite dabigatran, rivaroksaban ali apiksaban in začnite z zdravilom Roteas ob času naslednjega odmerka peroralnega antikoagulanta (glejte poglavje 5.1).
b The HR, two-sided CI are based on the Cox proportional hazards regression model including treatment and the following randomisation stratification factors as covariates: presenting diagnosis (PE with or without DVT, DVT only), baseline risk factors (temporary factors, all others), and the need for 30 mg edoxaban/edoxaban placebo dose at randomisation (yes/no).
b HR, dvostranski CI temeljita na Coxovem regresijskem modelu proporcionalnih tveganj, vključno z zdravljenjem in naslednjimi randomizacijskimi stratifikacijskimi dejavniki kot sospremenljivkami: diagnoza ob prvem pregledu (PE z GVT ali brez nje, samo GVT), izhodiščni dejavniki tveganja (začasni dejavniki, vsi drugi) in potreba po odmerku edoksabana
The Hazard Ratio (Edoxaban 60 mg vs. warfarin) for the primary endpoint in the centres with a lower average time of INR in the target range (INR TTR) for warfarin was 0.73 - 0.80 for the lowest 3 quartiles (INR TTR ≤ 57.7% to ≤ 73.9%).
Razmerje tveganja (edoksaban 60 mg proti varfarinu) za primarni končni opazovani dogodek v centrih s krajšim povprečnim časom INR v ciljnem območju (INR TTR) za varfarin je bilo 0,73 -0,80 za najnižje 3 kvartile (INR TTR ≤ 57,7 % do ≤ 73,9 %).
In both studies, the most common adverse reactions related to bleeding with edoxaban 60 mg based on adjudicated terms included cutaneous soft tissue haemorrhage (up to 5.9%) and epistaxis (up to 4.7%), while vaginal haemorrhage (9.0%) was the most common bleeding-related adverse reaction in Hokusai-VTE only.
V obeh študijah so najpogostejši neželeni učinki v zvezi s krvavitvami z edoksabanom 60 mg po strokovni presoji vključevali krvavitve v mehkih tkivih kože (do 5,9 %) in epistakso (do 4,7 %), medtem ko je bila vaginalna krvavitev(9,0 %) najpogostejši s krvavitvijo povezan neželeni učinek samo v študiji Hokusai-VTE.
Once an INR ≥ 2.0 is achieved, Roteas should be discontinued.
Ko se doseže stabilen INR ≥ 2,0, zdravilo Roteas ukinite.
• The Summary of Product Characteristics
• povzetek glavnih značilnosti zdravila;
a The event rate (%/yr) is calculated as number of events/subject-year exposure.
a Pogostnost dogodka (%/leto) je izračunana kot število dogodkov/izpostavljenost preiskovanskega leta.
Increased post-implantation pregnancy losses occurred in rats at 300 mg/kg/day (approximately 49 times the MRHD) and in rabbits at 200 mg/kg/day (approximately 65 times the MRHD) respectively.
Zvečane izgube zarodkov po implantaciji so se pojavljale pri podganah pri odmerku 300 mg/kg/dan (približno 49-kratnik MRHD) in pri kuncih pri 200 mg/kg/dan (približno 65-kratnik MRHD).
• antibiotic medicines (e.g. erythromycin)
• antibiotična zdravila (n.pr.
The median subject-year exposure was 15,471, and 15,840 for the 60 mg and 30 mg treatment groups, respectively; and the median subject-year follow-up was 19,191 and 19,216 for the 60 mg and 30 mg treatment groups, respectively.
Mediana izpostavljenost preiskovanec-leto je bila 15.471 in 15.840 za skupini, zdravljeni s 60 mg oziroma 30 mg; in mediano spremljanje preiskovanecleto je bilo 19.191 in 19.216 za skupini, zdravljeni s 60 mg oziroma 30 mg.