FrancophonIA/ELRC3.0 huggingface dataset:
English: Andexanet alfa is administered as an intravenous (IV) bolus at a target rate of approximately 30 mg/min over 15 (low dose) or 30 minutes (high dose), immediately followed by administration of a continuous infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1).
Slovenian: bolus s ciljno hitrostjo približno 30 mg/min v trajanju 15 minut (majhen odmerek) ali 30 minut (velik odmerek), ki mu takoj sledi aplikacija kontinuirane infuzije s hitrostjo 4 mg/min (majhen odmerek) ali 8 mg/min (velik odmerek) v trajanju 120 minut
English: Andexanet alfa is to be reconstituted and the 10 mg/mL solution then transferred to a suitable IV bag comprised of polyolefin (PO) or polyvinyl chloride (PVC) material without further dilution prior to administration by IV infusion using a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low protein-binding filter.
Slovenian: Andeksanet alfa je treba rekonstituirati, rekonstituirana raztopina (10 mg/ml) pa se brez nadaljnjega redčenja prenese v primerno vrečko za intravensko infuzijo, izdelano iz poliolefina (PO) ali polivinilklorida (PVC), čemur sledi dajanje z i.v.
English: Mannitol
Slovenian: Apiksaban
English: It reverses the effects of certain anticoagulants called factor Xa inhibitors (apixaban or rivaroxaban).
Slovenian: imenovanih zaviralci faktorja Xa (apiksaban ali rivaroksaban).
English: Conclusions presented by the European Medicines Agency on: • Conditional marketing authorisation
Slovenian: Sklepne ugotovitve, ki jih je predstavila Evropska agencija za zdravila, o:
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu pogosti mišični krči pogosti
English: Immune system disorders
Slovenian: Bolezni imunskega sistema urtikarija pogosti
English: Excipients: Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, polysorbate 80
Slovenian: L-argininijev klorid saharoza manitol polisorbat 80
English: Restoration of thrombin generation to within normal ranges (defined as one standard deviation from baseline levels) within two minutes and maintained for 20 hours was achieved with bolus only and bolus plus infusion for low-dose andexanet alfa in subjects on apixaban.
Slovenian: Ponovno tvorbo trombina znotraj normalnih mejnih vrednosti (opredeljenih z enim standardnim odklonom od izhodiščne ravni) v dveh minutah, ki se je ohranila 20 ur, so dosegli z dajanjem samo bolusa ter dajanjem bolusa in infuzije pri majhnih odmerkih andeksaneta alfa pri osebah, zdravljenih z placebo: bolus + 2-uri infuzije (n = 8) zdravilo ONDEXXYA: bolus 400 mg + 480 mg × 2-uri infuzije (n = 23)
English: Reversal of apixaban
Slovenian: Odprava učinka apiksabana
English: • dizziness
Slovenian: • srbenje,
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Slovenian: Podatkov o uporabi andeksaneta alfa pri nosečnicah ni. Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Package Leaflet: Information for the patient and user Ondexxya 200 mg powder for solution for infusion andexanet alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ondexxya 200 mg prašek za raztopino za infundiranje andeksanet alfa intravenska uporaba
English: The recommended dose regimen of Ondexxya is based on the dose of rivaroxaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of rivaroxaban (see table 3).
Slovenian: Priporočena shema odmerjanja zdravila Ondexxya temelji na odmerku rivaroksabana, ki ga bolnik jemlje v času, ko je potrebna odprava antikoagulacije, in času, ki je pretekel od bolnikovega zadnjega odmerka rivaroksabana (glejte preglednico 3).
English: The recommended dose regimen of andexanet alfa is based on the dose of rivaroxaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of rivaroxaban (see table 3).
Slovenian: Priporočena shema odmerjanja andeksaneta alfa temelji na odmerku rivaroksabana, ki ga bolnik jemlje v času, ko je potrebna odprava antikoagulacije, ter času, ki je pretekel od bolnikovega zadnjega odmerka rivaroksabana (glejte preglednico 3).
English: Flushing very common
Slovenian: zelo pogosti
English: No trials have been conducted to investigate the pharmacokinetics of andexanet alfa in patients with hepatic impairment.
Slovenian: Preskušanj za raziskavo farmakokinetike andeksaneta alfa pri bolnikih z okvaro ledvic niso izvedli.
English: Reversal of anticoagulation in healthy subjects aged 50-75 (Studies 14-503 and 14-504) In a prospective, randomized, placebo-controlled study, healthy subjects with a median age of 56.5 years on apixaban 5 mg twice daily received andexanet alfa (n=24) administered as a 400 mg IV bolus immediately followed by a 4 mg per minute IV infusion for 120 minutes (480 mg) or placebo (n=8).
Slovenian: Odprava antikoagulacije pri zdravih osebah, starih 50-75 let (študiji 14-503 in 14-504) V prospektivni, randomizirani, s placebom nadzorovani študiji so zdrave osebe z mediano starostjo
English: The recommended dose regimen of Ondexxya is based on the dose of apixaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of apixaban (see table 2).
Slovenian: Priporočena shema odmerjanja zdravila Ondexxya temelji na odmerku apiksabana, ki ga bolnik jemlje v času, ko je potrebna odprava antikoagulacije, in času, ki je pretekel od bolnikovega zadnjega odmerka apiksabana (glejte preglednico 2).
English: Nervous system disorders
Slovenian: Organski sistem/
English: The recommended dose regimen of andexanet alfa is based on the dose of apixaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of apixaban (see table 2).
Slovenian: Priporočena shema odmerjanja andeksaneta alfa temelji na odmerku apiksabana, ki ga bolnik jemlje v času, ko je potrebna odprava antikoagulacije, ter času, ki je pretekel od bolnikovega zadnjega odmerka apiksabana (glejte preglednico 2).
English: Each vial contains 200 mg of andexanet alfa.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 200 mg andeksaneta alfa.
English: • muscle spasms
Slovenian: • suha usta,
English: How Ondexxya is stored
Slovenian: Shranjevanje zdravila Ondexxya
English: • chest discomfort
Slovenian: • neugodje v prsih,
English: NAME OF THE MEDICINAL PRODUCT
Slovenian: Navodila za ravnanje z zdravilom
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja srbenje pogosti generalizirani pruritus pogosti
English: Ondexxya contains the active ingredient andexanet alfa.
Slovenian: Kaj je zdravilo Ondexxya in za kaj ga uporabljamo Zdravilo Ondexxya vsebuje učinkovino andeksanet alfa.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi tris (hidroksimetil) aminometan tris hidroklorid
English: • itching
Slovenian: • omotica,
English: In a similar study, subjects with a median age of 57 years on rivaroxaban 20 mg daily received andexanet alfa (n=26) administered as an 800 mg IV bolus immediately followed by an 8 mg per minute IV infusion for 120 minutes (960 mg) or placebo (n=13).
Slovenian: konec infuzije konec bolusa placebo: bolus + 2-uri infuzije (n = 13) zdravilo ONDEXXYA: bolus 800 mg + 960 mg × 2-uri infuzije (n = 26)
English: • excessive sweating
Slovenian: • povečano potenje,
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: anti-FXa (ng/ml)
English: § Measles virus1 Enders' Edmonston strain (live, attenuated)
Slovenian: Virus ošpic1, sev Enders' Edmonston (živ, oslabljen)
English: Varicella virus3 Oka/Merck strain (live, attenuated)
Slovenian: Virus varicella-zoster3, sev Oka/Merck (živ, oslabljen)
English: Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated) not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/3 strain (live, attenuated)
Slovenian: najmanj 3,99 log10 PFU** * 50-odstotni infektivni odmerek na celični kulturi (CCID = cell culture infectious dose) ** enote, ki tvorijo plak (PFU = plaque-forming units) (1) pridobljen iz celic piščančjih zarodkov (2) pridobljen iz humanih diploidnih pljučnih (WI-38) fibroblastov (3) pridobljen iz humanih diploidnih (MRC-5) celic
English: 10 vials + 10 pre-filled syringes with attached needle
Slovenian: 10 vial + 10 napolnjenih injekcijskih brizg z iglo
English: 1 vial + 1 pre-filled syringe without needle
Slovenian: 1 viala + 1 napolnjena injekcijska brizga brez igle
English: 1 vial + 1 pre-filled syringe with attached needle
Slovenian: 1 viala + 1 napolnjena injekcijska brizga z iglo
English: In such case, treatment must be stopped immediately.
Slovenian: V takih primerih je treba zdravljenje takoj prekiniti.
English: Given the
Slovenian: Ob upoštevanju naslednjega:
English: The PRAC noted that others studies will become available.
Slovenian: Odbor PRAC je izpostavil, da bodo na voljo druge študije;
English: • The PRAC noted that some of the studies have methodological limitations.
Slovenian: • odbor PRAC je ugotovil, da imajo nekatere študije metodološke omejitve.
English: The studies and their limitations were considered together with the overall evidence available to date.
Slovenian: Odbor je študije in njihove omejitve obravnaval skupaj s celotnimi dokazi, ki so bili na voljo.
English: However, the CMDh considered that an amendment was required in the package leaflet to improve clarity for patients that should tell their doctor if they have high blood pressure but also if they are being treated for high blood pressure.
Slovenian: Vendar je skupina CMDh menila, da je potrebna sprememba navodila za uporabo, da se izboljša jasnost za bolnike, ki se morajo posvetovati z zdravnikom, če imajo visok krvni tlak oziroma če se zdravijo zaradi visokega krvnega tlaka.
English: Some studies show an increased risk while others do not suggest a risk and therefore have not corroborated the signal.
Slovenian: Nekatere študije so pokazale povečano tveganje, druge pa ne, zato niso podprle pomislekov;
English: In addition, there is limited experience on the safety and efficacy of the use of testosterone in patients over 65 years of age.
Slovenian: Poleg tega so izkušnje glede varnosti in učinkovitosti uporabe testosterona pri bolnikih, starejših od 65 let, omejene.
English: Also, the RHYME study, an observational registry study performed in 6 European countries evaluating the association between TT (over two years) and prostate health outcome in men with hypogonadism also looked at health outcomes, as secondary endpoints.
Slovenian: Tudi v študiji RHYME, opazovalni registrski študiji, izvedeni v 6 evropskih državah, v kateri so ocenjevali povezavo med zdravljenjem s testosteronom (v obdobju dveh let) in izidom glede zdravja prostate pri moških s hipogonadizmom, so proučili zdravstvene izide kot sekundarne opazovane dogodke.
English: Further studies will be needed to provide relevant safety and efficacy data in this patient population.
Slovenian: Potrebne bodo dodatne študije, s katerimi bodo pridobili podatke o varnosti in učinkovitosti za to skupino bolnikov.
English: Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), pg 238, abstract # 1353; available at: https://www.aace.com/files/late-breaking-abstracts-2014.pdf 9 Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress
Slovenian: Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), pg 238, abstract # 1353; available at: https://www.aace.com/files/late-breaking-abstracts-2014.pdf 9 Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress ME, Ballard R, Schwartz RS.
English: Testosterone Deficiency in Men: Systematic Review and Standard Operating Procedures for Diagnosis and Treatment.
Slovenian: Testosterone Deficiency in Men: Systematic Review and Standard Operating Procedures for
English: • The PRAC considered the procedure under Article 31 of directive 2001/83/EC for testosteronecontaining medicinal products.
Slovenian: • odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo testosteron;
English: The next PSUR, will have the common DLP to all testosterone-containing medicinal products of 31 December 2015.
Slovenian: Zaključek vnosa podatkov za naslednje poročilo PSUR za vsa zdravila, ki vsebujejo testosteron, bo 31. decembra 2015.
English: Testosterone is an androgenic hormone secreted by the Leydig cells in the testis.
Slovenian: Testosteron je androgeni hormon, ki ga izločajo Leydigove celice v modih.
English: On the other hand, testosterone stimulates red blood proliferation, which theoretically could increase the risk of thromboembolic events.
Slovenian: Po drugi strani testosteron spodbuja proliferacijo eritrocitov, kar lahko teoretično poveča tveganje trombemboličnih dogodkov.
English: The clinical symptoms depend on the age of onset androgen deficiency.
Slovenian: Klinični simptomi so odvisni od starosti pri prvem pojavu pomanjkanja androgenov.
English: It is expected that the marketing authorisation holders continue to monitor cardiovascular events and it is expected that findings of ongoing studies will be reflected in periodic updated safety reports (PSURs) when available.
Slovenian: Pričakuje se, da bodo imetniki dovoljenj za promet z zdravilom še naprej spremljali kardiovaskularne dogodke in da se bodo ugotovitve potekajočih študij vključile v redno posodobljena poročila o varnosti zdravila (PSUR), ko bodo na voljo.
English: Testosterone therapy is not associated with higher risk of myocardial infarction or stroke: The low T
Slovenian: Testosterone therapy is not associated with higher risk of myocardial infarction or stroke: The low T experience.
English: The CMDh considered the below PRAC recommendation with regard to testosterone containing medicinal products:
Slovenian: Skupina CMDh je proučila spodnje priporočilo odbora PRAC v zvezi z zdravili, ki vsebujejo testosteron:
English: If the hypogonadism develops before puberty e.g. as part of a genetic disease, the men will exhibit eunuchoid proportions, delayed of secondary sex characterises and high pitched voice.
Slovenian: Če se hipogonadizem razvije pred puberteto, npr. kot del genetske bolezni, bo imel moški evnuhoidne zunanje znake, zapoznel razvoj sekundarnih spolnih značilnosti in visok glas.
English: The PRAC also recognised that testosterone may have both direct and indirect effect on the cardiovascular systems: low testosterone increases the risk of the metabolic syndrome, which could potentially increase the risk of adverse cardiovascular events.
Slovenian: Odbor PRAC je prav tako upošteval, da ima lahko testosteron neposreden in posreden učinek na srčnožilni sistem: nizka raven testosterona poveča tveganje metabolnega sindroma, ki lahko poveča tveganje za pojav neželenih kardiovaskularnih dogodkov.
English: The CMDh, having considered the PRAC recommendation dated 9 October 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the variation of the marketing authorisations of testosterone containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Slovenian: CMDh je na podlagi preučitve priporočila, ki ga je dne 9. oktobra 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES podal PRAC, sprejela sporazum o spremembi dovoljenj za promet z zdravili, ki vsebujejo testosteron , skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III, in pod pogoji, določenimi v Prilogi IV.
English: • The Committee agreed, that it is justified to reflect in the product information of all testosterone-containing medicinal products the current knowledge on cardiovascular risks associated with testosterone therapy and recommended changes in section 4.1 (therapeutic indications), section 4.4 (warnings and precautions for use) and section 4.8 (undesirable effects) of the Summary of Product Characteristics.
Slovenian: • odbor se je strinjal, da je treba v informacije o zdravilu za vsa zdravila, ki vsebujejo testosteron, vključiti trenutno vedenje o kardiovaskularnih tveganjih, povezanih z zdravljenjem s testosteronom, in priporočil spremembe v poglavjih 4.1 (terapevtske indikacije), 4.4 (opozorila in previdnostni ukrepi) in 4.8 (neželeni učinki) v povzetku glavnih značilnosti zdravila;
English: The wording was amended accordingly in section 2 of the Package Leaflet as set out in Annex III.
Slovenian: Skladno s tem se je spremenilo besedilo v poglavju 2 navodila za uporabo, kot je določeno v Prilogi III.
English: Also, that there is limited data regarding elderly patients above the age of 65 and this will also be reflected in the warning section of the product information of all testosterone-containing medicinal products.
Slovenian: Podatki glede bolnikov, starejših od 65 let, so omejeni, kar bo vključeno v poglavje z opozorili v informacijah o zdravilu za vsa zdravila, ki vsebujejo testosteron.
English: The marketing authorisation holders are requested to investigate and report in the next PSUR on the usage of these products in this patient population and to consider if the pattern of adverse events is comparable to other age groups.
Slovenian: Imetniki dovoljenj za promet z zdravilom morajo raziskati uporabo teh zdravil pri tej skupini bolnikov in o njih poročati v naslednjem poročilu PSUR, prav tako pa morajo pretehtati, ali je vzorec neželenih dogodkov primerljiv z drugimi starostnimi skupinami.
English: Testosterone, as well as other androgens and anabolic steroids, should be used cautiously in patients with cardiovascular disorders, renal or hepatic impairment, epilepsy, migraine, diabetes mellitus or other conditions that may be aggravated by the possible fluid retention or oedema caused.
Slovenian: Testosteron in druge androgene ter anabolne steroide je treba uporabljati previdno pri bolnikih s kardiovaskularnimi motnjami, ledvično ali jetrno okvaro, epilepsijo, migreno, sladkorno boleznijo ali drugimi stanji, ki jih lahko poslabša morebitna retencija tekočine ali posledični edem.
English: Based on all the above discussed, the PRAC considered justified to reflect in the product information of all testosterone containing medicinal products approved in the European Union that prescribing testosterone for hypogonadism should be based upon confirmation of both clinical features and biochemical testing.
Slovenian: Na podlagi zgornje razprave je odbor PRAC menil, da je treba v informacije o zdravilu za vsa zdravila, ki vsebujejo testosteron in so odobrena v Evropski uniji, vključiti, da mora predpisovanje testosterona pri hipogonadizmu temeljiti na potrditvi kliničnih značilnosti in biokemijskih preiskavah.
English: It is an essential hormone for the development of male reproductive tissues as the testis and the prostate and in promoting secondary sexual characteristics such as increased muscle, bone mass, and the growth of body hair (Dollery et al., 19911).
Slovenian: Je esencialni hormon za razvoj moških reproduktivnih tkiv, kot so moda in prostata, ter za spodbujanje sekundarnih spolnih značilnosti, kot so povečana mišična masa, kostna masa in rast dlak po telesu (Dollery in sod.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of testosterone-containing medicinal products remains favourable subject to the conditions to the marketing authorisations, and taking into account the amendments to the product information recommended.
Slovenian: Odbor PRAC je posledično zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo testosteron, še naprej ugodno pod pogojem, da se upoštevajo pogoji dovoljenj za promet z zdravili ter priporočene spremembe informacij o zdravilu.
English: • The Committee considered the studies that heightened concerns about the increased risk of cardiovascular events associated with testosterone therapy and available data submitted from clinical trials, observational studies, meta-analyses, post-marketing data and further published data.
Slovenian: • odbor je upošteval študije, ki so povečale pomisleke glede povečanega tveganja kardiovaskularnih dogodkov, povezanih z zdravljenjem s testosteronom, in razpoložljive podatke iz kliničnih preskušanj, opazovalnih študij, metaanaliz, podatke iz obdobja trženja ter dodatno objavljene podatke;
English: Results suggest that rates of prostate cancer and cardiovascular events were within the anticipated range, with no evidence of increased risk in treated versus untreated patients.
Slovenian: Rezultati kažejo, da so bili deleži raka prostate in kardiovaskularnih dogodkov znotraj pričakovanega razpona, pri čemer ni bilo dokazov o povečanem tveganju pri zdravljenih bolnikih v primerjavi z nezdravljenimi.
English: The PRAC acknowledged that some studies show an increased risk of cardiovascular events in men treated with testosterone.
Slovenian: Odbor PRAC je potrdil, da nekatere študije kažejo povečano tveganje kardiovaskularnih dogodkov pri moških, zdravljenih s testosteronom.
English: • The PRAC also concluded that there was the need for all MAHs to closely monitor cardiovascular risk and discuss the findings including venous thromboembolic events and possible mechanism(s) and usage pattern and adverse events in patients older than 65 years in the next PSUR.
Slovenian: • odbor PRAC je prav tako sklenil, da morajo vsi imetniki dovoljenja za promet z zdravilom skrbno spremljati kardiovaskularno tveganje in ugotovitve, vključno z venskimi trombemboličnimi dogodki, morebitnim(i) mehanizmom(i), vzorcem uporabe in neželenimi dogodki pri bolnikih, starejših od 65 let, opisati v naslednjem poročilu PSUR.
English: The PRAC noted that the findings from several other observational studies, clinical trials and meta-analysis of randomised clinical trials do not provide evidence of an association between testosterone and cardiovascular events.
Slovenian: Odbor PRAC je izpostavil, da ugotovitve mnogih drugih opazovalnih študij, kliničnih preskušanj in metaanaliz randomiziranih kliničnih preskušanj ne dokazujejo povezave med testosteronom in kardiovaskularnimi dogodki.
English: It is known that in patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Slovenian: Znano je, da lahko zdravljenje s testosteronom pri bolnikih s hudo srčno, jetrno ali ledvično insuficienco ali ishemično srčno boleznijo povzroči hude zaplete, za katere je značilen edem s kongestivnim srčnim popuščanjem ali brez njega.
English: Hypogonadism in men is a congenital or acquired syndrome, in which the testis fails to produce physiological levels of testosterone and spermatozoa, as there is a disruption in the hypothalamicpituitary-testicular axis (HPT).
Slovenian: Hipogonadizem pri moških je kongenitalni ali pridobljeni sindrom, pri katerem moda ne proizvajajo fizioloških ravni testosterona in semenčic, saj pride do motnje na osi hipotalamus-hipofiza-moda (HHM).
English: The PRAC reviewed all data available from clinical trials, observational studies, meta-analyses, postmarketing data and further published data on the cardiovascular risks associated with testosterone therapy.
Slovenian: Odbor PRAC je pregledal vse razpoložljive podatke iz kliničnih preskušanj, opazovalnih študij, metaanaliz, podatke iz obdobja trženja in dodatne objavljene podatke o kardiovaskularnem tveganju, povezanem z zdravljenjem s testosteronom.
English: Therefore, taking the totality of data into account it is judged that the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive.
Slovenian: Ko je odbor upošteval celotne podatke, je presodil, da so dokazi glede povečanega kardiovaskularnega tveganja, povezanega z uporabo testosterona, še vedno šibki in neprepričljivi.