FrancophonIA/ELRC3.0 huggingface dataset:
English: The factors most strongly inhibited are thrombin and Factor Xa, but also factors of contact activation, intrinsic system and the Factor VIIa/tissue factor complex.
Slovenian: Faktorja, ki sta najmočneje inhibirana, sta trombin in faktor Xa, a tudi faktorji kontaktne aktivacije, intrinzičnega sistema in faktor VIIa/kompleks tkivnega faktorja.
English: Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD):
Slovenian: Populacijski farmakokinetični parametri za ATryn, pridobljeni iz iste študije, so pokazali (povprečje ± SD):
English: A risk to the suckling child cannot be excluded.
Slovenian: Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
English: This medicine is intended for single use only.
Slovenian: To zdravilo je namenjeno le za enkratno uporabo.
English: However, chemical and physical stability has been demonstrated for 3 hours after reconstitution and 8 hours after dilution at a temperature not above 25°C.
Slovenian: Vendar pa sta bili kemična in fizikalna stabilnost zdravila med uporabo dokazani za 3 ure po rekonstituciji in 8 ur po redčenju pri temperaturi do 25 °C.
English: Frequencies are defined as: common (≥ 1/100 to < 1/10) and uncommon (≥1/1,000 to <1/100).
Slovenian: Po pogostosti so neželeni učinki opredeljeni kot: pogosti (≥1/100 do <1/10) in občasni (≥1/1000 do
English: Compatibility with PVC infusion lines with in-line filters has been established.
Slovenian: Dokazana je bila združljivost s PVC-infuzijskimi kanali s filtri.
English: As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Slovenian: Kot pri vsakem intravenskem beljakovinskem zdravilu so možne alergijske reakcije zaradi preobčutljivosti.
English: In case of shock, standard medical treatment should be administered.
Slovenian: Če nastopi šok, je potrebna običajna zdravniška oskrba.
English: This may result in a higher tendency to form clots in your blood vessels.
Slovenian: To lahko povzroči večjo nagnjenost k nastajanju strdkov v vaših žilah.
English: The results of completed study GTC AT HD 012-04 and in particular the results of investigations in pregnant women treated during the peri-partum period have been submitted.
Slovenian: Predloženi so bili rezultati dokončane študije GTC AT HD 012-04 in še zlasti rezultati raziskav pri nosečnicah, zdravljenih v obdobju pred porodom, med porodom in po njem.
English: To protect you from developing blood clots the medicine will continue to be administered to you until your doctor determines it safe to stop treatment.
Slovenian: Za zaščito pred nastajanjem krvnih strdkov boste zdravilo prejemali še naprej, dokler zdravnik ne ugotovi, da je varno prenehati z uporabo zdravila.
English: Adverse reactions are presented below by system organ class and absolute frequency.
Slovenian: Neželeni učinki so spodaj predstavljeni po organskih sistemih in absolutni pogostosti.
English: SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR
Slovenian: UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA
English: Around major surgical procedures this tendency to clot is even more increased.
Slovenian: Med večjimi operacijami je ta nagnjenost k nastajanju strdkov še večja.
English: The specific activity of ATryn is approximately 7 IU/mg protein.
Slovenian: Specifična aktivnost zdravila ATryn je približno 7 i.e./mg beljakovin.
English: Therapeutic Monitoring and Dose Adjustment
Slovenian: Terapevtsko spremljanje in prilagajanje odmerka
English: • Area under the curve: 587.88 ± 1.63 (% x h)
Slovenian: • Površina pod krivuljo: 587,88 ± 1,63 (% x h)
English: Available data do not suggest harmful effects to the mother or infant.
Slovenian: Po podatkih, ki so na voljo, ne kaže, da bi škodoval materi ali dojenčku.
English: This medicine is used in patients who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Slovenian: To zdravilo se uporablja pri bolnikih, ki imajo »prirojeno pomanjkanje antitrombina« (podedovane nizke ravni beljakovine antitrombin).
English: Vials should be brought at temperature not above 25°C prior to reconstitution.
Slovenian: Pred rekonstituiranjem morajo imeti viale temperaturo, ki ne presega 25 °C.
English: This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti popolnih informacij o tem zdravilu.
English: Pharmacotherapeutic Group: Antithrombotic agents: heparin group; ATC code: B01AB02.
Slovenian: Farmakoterapevtska skupina: Antitrombotiki: heparinska skupina heparinov, oznaka ATC: B01AB02.
English: The powder should be reconstituted with 10 ml of water for injections (WFI) injected along the side wall of the vial and gently swirled (not shaken) to prevent foaming.
Slovenian: Prašek je treba rekonstituirati z 10 ml vode za injekcije, ki jo vbrizgamo vzdolž stene viale in rahlo zavrtimo (ne stresamo), da preprečimo penjenje.
English: If you have an inborn deficiency of antithrombin, your blood level of antithrombin is lower than normal.
Slovenian: Če imate prirojeno pomanjkanje antitrombina, je raven antitrombina v krvi nižja od običajne.
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMEA) bo pregledala vse nove informacije, ki bodo morda na voljo vsako leto, SPC pa bo po potrebi posodobljen.
English: Please discuss possibility of stopping the treatment with your doctor.
Slovenian: Z zdravnikom se pogovorite o možnosti prenehanja zdravljenja.
English: Other medicines and ATryn
Slovenian: Druga zdravila in zdravilo ATryn
English: What ATryn is and what it is used for
Slovenian: KAJ JE ZDRAVILO ATryn IN ZA KAJ GA UPORABLJAMO
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: This medicine has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v »izjemnih okoliščinah«.
English: This medicine contains 38 mg (1.65 mmol) sodium per 10 ml vial.
Slovenian: To zdravilo vsebuje 38 mg (1,65 mmol) natrija na 10 ml vialo.
English: The antithrombin activity level should be maintained above 80% for the duration of the treatment, unless clinical particulars would indicate a different effective level.
Slovenian: Raven aktivnosti antitrombina morate v času zdravljenja vzdrževati nad 80 %, razen če klinični podatki ne narekujejo drugačne učinkovite ravni.
English: Antithrombin, a 58 kD, 432 amino-acid glycoprotein, belongs to the serpin (serine protease inhibitor) superfamily.
Slovenian: Antitrombin, 58 kD, 432 aminokislinski glikoprotein, ki pripada naddružini serpinov (zaviralcev serinske proteaze).
English: In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
Slovenian: V telesu antitrombin blokira trombin, snov, ki ima osrednjo vlogo v procesu strjevanja krvi.
English: During consumptive states (e.g. major surgery, concomitant use of heparin) the actual dose may be higher.
Slovenian: Med večjo porabo (npr. večje operacije, hkratna uporaba heparina) je lahko dejanski odmerek višji.
English: The solution should be slightly yellow, clear to slightly opalescent.
Slovenian: Raztopina mora biti rumenkasta, bistra do rahlo opalescentna.
English: Therefore, it is important that your antithrombin blood level be maintained at sufficient levels in these situations.
Slovenian: Zato je pomembno, da v takih razmerah vzdržujete primerno raven antitrombina v krvi.
English: However due to the difference in pharmacokinetic characteristics of this medicine in pregnant versus non-pregnant patients no recommendation for dosing in pregnancy can be given at this time (see section 4.4).
Slovenian: Zaradi razlik v farmakokinetičnih lastnostih tega zdravila pri nosečih in nenosečih bolnicah trenutno ni mogoče podati priporočila za odmerjanje med nosečnostjo (glejte poglavje 4.4).
English: The MAH shall ensure that in each Member State where Atryn is marketed, all healthcare professionals who are expected to prescribe and use Atryn have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da so v vsaki državi članici, v kateri bo zdravilo ATryn tržil, vsi zdravstveni delavci, ki bodo predvidoma predpisovali/uporabljali zdravilo ATryn, prejeli naslednji izobraževalni paket oziroma imajo dostop do njega:
English: • Distribution half-life: 1.74 ± 1.28 h, elimination half-life: 10.16 ± 1.28 h.
Slovenian: • Porazdelitvena razpolovna doba: 1,74 ± 1,28 h, razpolovna doba izločanja: 10,16 ± 1,28 h.
English: The educational material for healthcare professionals is aimed at increasing the awareness about the potential efficacy issues resulting from off-label use of Atryn.
Slovenian: Namen tega izobraževalnega gradiva za zdravstvene delavce je povečati osveščenost o morebitnih težavah z učinkovitostjo pri neodobreni uporabi zdravila ATryn.
English: • Mean residence time (MRT): 8.57 ± 1.24 h
Slovenian: • Povprečen čas zadrževanja (MRT): 8,57 ± 1,24 h.
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Slovenian: Občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov):
English: Powder in glass vial (type I) with a stopper (siliconized bromobutyl rubber) and capped with a seal (aluminum) and flip-off cap (plastic).
Slovenian: Prašek v stekleni viali (tipa I) z zamaškom (silikonizirana bromobutilna guma), prekritim z zaporko (aluminij) in snemljivim pokrovčkom (plastika).
English: This medicinal product contains 1.65 mmol (or 37.9 mg) sodium per vial.
Slovenian: To zdravilo vsebuje 1,65 mmol (ali 37,9 mg) natrija na odmerek.
English: Name and address of the manufacturer(s) of the biological active substance(s) Therapure Biopharma Inc.
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine Therapure Biopharma Inc.
English: One International Unit (IU) of antithrombin activity is equivalent to that quantity of antithrombin in one ml of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti antitrombina je enaka količini antitrombina v enem ml običajne človeške plazme.
English: See therapeutic monitoring and dose adjustment recommendations below.
Slovenian: Spodaj si oglejte terapevtsko spremljanje in priporočila za prilagajanje odmerka.
English: The first contains the reactive centre and provides a cleavage site for proteinases such as thrombin, a prerequisite for forming a stable proteinaseinhibitor complex.
Slovenian: Prva vsebuje aktivno mesto, ki predstavlja cepitveno mesto za proteaze, kot je trombin, ki je najpomembnejši za nastajanje stabilnega kompleksa zaviralca proteaze.
English: This may be in the vessels of your legs (deep vein thrombosis) or in other vessels of your body (thromboembolism).
Slovenian: To so lahko žile nog (tromboza globokih ven) ali drugih žilah v telesu (tromboembolizem).
English: Hypersensitivity to goat proteins or goat milk components.
Slovenian: Preobčutljivost na beljakovine kozjega mleka ali sestavine kozjega mleka.
English: Protocol GTC AT HD 012-04: A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis.
Slovenian: Protokol: GTC AT HD 012-04: Multicentrična, multinacionalna študija za ocenitev varnosti in učinkovitosti antitrombina alfa pri bolnikih z dednim pomanjkanjem antitrombina (AT) v razmerah z zelo visokim tveganjem za nastanek tromboze.
English: Therefore your doctor will carefully monitor the use of this medicine when administered together with these anti-clotting medicines.
Slovenian: Zdravnik bo skrbno spremljal uporabo tega zdravila, če ga boste uporabljali skupaj s temi antikoagulanti.
English: Therefore it is not recommended to breastfeed whilst being treated with this medicine.
Slovenian: Zato med zdravljenjem s tem zdravilom dojenje ni priporočljivo.
English: The inhibitor-coagulation enzyme complexes are removed by the reticulo-endothelial system.
Slovenian: Kompleksi inhibitorja in koagulacijskega encima se odstranjujejo peko retikuloendotelijskega sistema.
English: The number of units of antithrombin alfa administered is expressed in International Units (IU), which is related to the current WHO standard for antithrombin concentrate.
Slovenian: Število uporabljenih enot antitrombina alfa je izraženo v mednarodnih enotah (i.e.), kar se nanaša na trenutni standard WHO za koncentrat antitrombina.
English: ATryn is not indicated for use in pregnant women.
Slovenian: Zdravilo ATryn ni indicirano za nosečnice.
English: In the treatment of congenital antithrombin deficiency, the dose and duration of treatment should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment.
Slovenian: Pri zdravljenju prirojenega pomanjkanja antitrombina je treba odmerek in trajanje zdravljenja prilagoditi posameznemu bolniku ob upoštevanju družinske anamneze, povezane s tromboembolijo, ter upoštevanju dejanskih dejavnikov kliničnega tveganja in laboratorijske ocene.
English: It is used when the patients are having surgery, to prevent problems due to the formation of blood clots in the vessels.
Slovenian: Uporablja se pri operacijah teh bolnikov za preprečitev težav zaradi nastajanja krvnih strdkov v žilah.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, našteto v poglavju 6.1
English: Antithrombin (AT) activity in plasma is expressed either as a percentage (relative to human plasma) or in International Units (relative to the International Standard for antithrombin in plasma).
Slovenian: Aktivnost antitrombina (AT) v plazmi je izražena kot odstotek (glede na človeško plazmo) ali kot mednarodne enote (glede na mednarodni standard za vsebnost antitrombina v plazmi).
English: In other clinical trials with acquired antithrombin deficient cardiac surgery patients (n=118) and healthy volunteers (n=102), undesirable effects reported to be related to treatment with ATryn that were observed more than once are listed by System Organ Class in the table below.
Slovenian: Pri drugih kliničnih preskušanjih na bolnikih po operaciji srca in pomanjkanjem antitrombina (n =118) in zdravih prostovoljcih (n =102) so neželeni učinki, povezani z zdravljenjem z zdravilom ATryn, ki so jih opazili več kot enkrat, navedeni po razvrstitvi telesnega sistema organov v spodnji preglednici.
English: The second is a glycosaminoglycan binding domain responsible for the interaction with heparin and related substances, which accelerates the inhibition of thrombin.
Slovenian: Druga pa je domena, ki veže glikozaminoglikan in skrbi za medsebojno delovanje s heparinom in sorodnimi snovmi, ki pospešijo inhibicijo trombina.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike je treba poučiti o zgodnjih znakih preobčutljivostnih reakcij, vključno z izpuščaji, generalizirano utrikarijo, tiščanjem v prsih, sopihanjem, hipotenzijo in anafilaksijo.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ATryn therapy taking into account the benefit of breastfeeding for the child and the
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom ATryn, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Read all of this leaflet carefully before you start using this medicine because it contains important
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, France
Slovenian: Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, Francija
English: Due to differences in pharmacokinetics of antithrombin alfa and plasma-derived antithrombin, treatment should follow the specific dose recommendations described below.
Slovenian: Zaradi razlike v farmakokinetiki antitrombina alfa in antitrombina, pridobljenega iz plazme, morate ob zdravljenju upoštevati natančna priporočila za odmerjanje, opisana spodaj.
English: The required loading dose is determined using the following formula:
Slovenian: Potrebni začetni odmerek določite z uporabo te formule:
English: It is unknown whether antithrombin alfa or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se antitrombin alfa ali njegovi presnovki izločajo v materino mleko.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: If diluted, the solution prepared in infusion bags should be administered immediately and no longer than 8 hours after dilution.
Slovenian: Razredčeno raztopino, pripravljeno v infuzijskih vrečkah, je treba uporabiti takoj in najkasneje v 8 urah po redčenju.
English: If you experience hives, itchy welts or wheals all over the skin, tightness of the chest, wheezing (difficulty breathing), you should immediately contact your physician since these might be symptoms of a severe allergic reaction.
Slovenian: Če se pojavijo izpuščaj, koprivnica, srbeči mehurčki ali izpuščaji po vsej koži skupaj s tiščanjem v prsih, sopenjem (oteženo dihanje), morate to takoj povedati zdravniku, saj so to lahko znaki hude alergijske reakcije.
English: The required maintenance dose for surgical patients is given as a continuous infusion and is determined using the following formula:
Slovenian: Potrebni vzdrževalni odmerek pri operiranih bolnikih se daje kot neprekinjena infuzija, določa pa se s to formulo:
English: If you use more ATryn than you should
Slovenian: Če ste vzeli večji odmerek zdravila ATryn, kot bi smeli
English: Antithrombin activity is greatly enhanced by heparin and the anticoagulant effects of heparin depend on the presence of antithrombin.
Slovenian: Heparin močno poveča aktivnost antitrombina, antikoagulantni učinki heparina pa so odvisni od prisotnosti antitrombina.
English: - In order to properly adjust the dose of the anticoagulant and to avoid excessive hypocoagulability, controls of the extent of anticoagulation (APTT, and where appropriate anti-Factor Xa activity) should be performed regularly, at close intervals and in particular in the first minutes/hours following the start
Slovenian: Da bi ustrezno prilagodili odmerek antikoagulanta in se izognili prekomerni hipokoagulabilnosti, je treba redno in dovolj pogosto, še posebej v prvih minutah/urah po začetku uporabe antitrombina, preverjati stopnjo antikoagulacije (aktivirani parcialni tromboplastinski čas in kjer je primerno, aktivnost antifaktorja Xa).
English: Subsequently, antithrombin activity should be checked 1-2 times a day and dose adjustments made accordingly.
Slovenian: Aktivnost antitrombina morate nato preverjati 1do 2-krat dnevno in odmerek ustrezno prilagajati.
English: Prior to launch of Atryn in each Member State the MAH must agree about 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 zdravila ATryn na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega gradiva, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
English: The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag with a 0.22 micron pore size in-line filter.
Slovenian: Rekonstituirano zdravilo se daje z intravensko infuzijo s sterilno injekcijsko brizgo za enkratno uporabo ali z infuzijsko vrečko s filtrom z velikostjo por 0,22 mikrona.
English: Any unused medicinal product should be disposed of in accordance with local requirements.
Slovenian: Neporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
English: It is normally given in association with heparin or low molecular weight
Slovenian: Običajno se uporablja v povezavi s heparinom ali heparinom z nizko molekulsko maso.
English: It is unknown whether it is present in breast milk.
Slovenian: Ni znano, ali se zdravilo izloča v materino mleko.
English: Antithrombin alfa should therefore not be used in pregnant women.
Slovenian: Zato antitrombina alfa ne uporabljajte pri nosečnicah.
English: The half-life of recombinant antithrombin may be altered with concomitant treatment with these anticoagulants due to an altered antithrombin turnover.
Slovenian: Razpolovna doba rekombinantnega antitrombina se lahko ob hkratnem zdravljenju s temi antikoagulanti zaradi spremenjenega nastajanja in razgradnje antitrombina spremeni.
English: Animal studies performed in rats did not indicate harmful effects on parturition, embryonal/foetal and post-natal development.
Slovenian: Študije na podganah niso pokazale škodljivih vplivov na porod, razvoj zarodka/ploda in otroka po porodu.
English: ATryn contains antithrombin alfa which is similar to the naturally occurring human antithrombin.
Slovenian: Zdravilo ATryn vsebuje antitrombin alfa, ki je podoben naravnemu humanemu antitrombinu.
English: A marketing authorization variation will be submitted to seek to expand the indication and dosing of pregnant women.
Slovenian: Vložena bo sprememba dovoljenja za promet z zdravilom z namenom pridobitve dovoljenja za razširjeno področje uporabe in način odmerjanja pri nosečnicah.
English: Treatment should be continued until the risk for venous thromboembolisms is reduced and/or when effective follow-on anticoagulation has been established.
Slovenian: Z zdravljenjem nadaljujte, dokler ni tveganje za venski tromboembolizem zmanjšano in/ali do uvedbe učinkovitega nadaljevalnega zdravljenja z antikoagulanti.
English: It is normally given in association with heparin or low molecular weight heparin (another medicine that helps to prevent blood clots).
Slovenian: Običajno se daje s heparinom ali nizkomolekularnim heparinom (drugo zdravilo, ki pomaga pri preprečevanju nastajanja krvnih strdkov).
English: When ATryn is used together with heparin (an anti-clotting medicine), or some other anti-clotting medicines, this may increase the risk of bleeding.
Slovenian: Ko zdravilo ATryn uporabljate skupaj s heparinom (zdravilo proti strjevanju krvi) ali kakšnimi drugimi zdravili proti strjevanju krvi, to lahko poveča nevarnost krvavitve.
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Slovenian: Bolnike je treba zaradi morebitnih simptomov med infundiranjem natančno nadzorovati in skrbno opazovati.
English: Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e.g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Slovenian: Nadomeščanje antitrombina med uporabo antikoagulantov, ki okrepijo antikoagulantno aktivnost antitrombina (npr. heparin, heparin z nizko molekulsko maso), lahko poveča nevarnost krvavitve.
English: The dose should be adjusted on the basis of laboratory measurements of antithrombin activity.
Slovenian: Odmerek je treba prilagoditi na osnovi laboratorijskih meritev aktivnosti antitrombina.