FrancophonIA/ELRC3.0 huggingface dataset:
English: To test whether you developed an allergic reaction, blood may be collected and tested before and some time after you have been treated with ATryn.
Slovenian: Za preverjanje, ali se je alergijska reakcija pojavila, bo morda potreben odvzem in preiskava krvi pred zdravljenjem z zdravilom ATryn in včasih tudi po njem.
English: This medicine should therefore not be used if you are less than18 years.
Slovenian: Informacij o uporabi zdravila ATryn pri bolnikih, starih manj kot 18 let ni, zato se to zdravilo ne sme uporabljati, če ste stari manj kot 18 let.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1, 10 OR 25 VIALS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (1 VIALA, 10 ALI 25 VIAL)
English: The other ingredients are: glycine, sodium chloride, sodium citrate
Slovenian: Pomožne snovi: glicin, natrijev klorid, natrijev citrat.
English: In a formal clinical trial employing serial Duplex ultrasound examinations, antithrombin alfa was shown to be effective in the prevention of thromboembolic events in fourteen congenital antithrombin deficient patients in clinical high risk situations.
Slovenian: V uradnih kliničnih preskušanjih, kjer so izvedli vrsto dvojnih ultrazvočnih pregledov, je antitrombin alfa uspešno preprečeval tromboembolične dogodke pri štirinajstih bolnikih s prirojenim pomanjkanjem antitrombina v klinično zelo nevarnih razmerah.
English: • Information regarding the resulting efficacy issues associated with off-label use of ATryn, especially
Slovenian: • Informacije o posledičnih težavah z učinkovitostjo, povezanih z neodobreno uporabo zdravila ATryn, zlasti pri pediatrični populaciji.
English: Clinical and biological surveillance when antithrombin is used together with heparin, low molecular weight heparin or other anticoagulants which potentiate the anticoagulant activity of antithrombin:
Slovenian: Potreben je klinični in biološki nadzor, ko se antitrombin uporablja skupaj s heparinom, heparinom z nizko molekulsko maso ali drugimi antikoagulanti, ki okrepijo antikoagulantno aktivnost antitrombina:
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Slovenian: Odlaganje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: After intravenous administration of ATryn (intravenous bolus dose of 50 IU/kg or 100 IU/kg body weight) to congenital antithrombin deficient patients without clinical symptoms of thrombosis, and not using heparin, the incremental recovery was 2.07 ± 1.54 %/IU/kg body weight (mean ± SD).
Slovenian: Po intravenski uporabi zdravila ATryn (intravenski bolusni odmerek 50 i.e./kg ali 100 i.e./kg telesne mase) pri bolnikih s prirojenim pomanjkanjem antitrombina brez kliničnih simptomov tromboze, ki ne uporabljajo heparina, je bilo postopno okrevanje pri 2,07 ± 1,54 %/i.e./kg telesne mase (povprečje ± SD).
English: Check AT activity level 30 minutes after any change in infusion rate, or four hours after a value within the target range.
Slovenian: 30 minut po vsaki spremembi stopnje infuzije ali štiri ure po tem, ko je bila vrednost znotraj ciljnega razpona, preverite raven aktivnosti antitrombina.
English: You can help by reporting any side effects you may get.
Slovenian: Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neželenemem učinkuu zdravila, ki bi se utegnil pojaviti pri vas.
English: Frequent antithrombin activity assessments and dosing adjustments may be necessary when starting treatment and just
Slovenian: Morda bodo potrebne pogoste ocene aktivnosti antitrombina in prilagajanje odmerka, ko začenjate z zdravljenjem in takoj po operaciji.
English: Due to differences in pharmacokinetic characteristics of ATryn in pregnant versus non-pregnant patients, recommendations for dosing in pregnancy or in the peripartum period cannot be given.
Slovenian: Zaradi razlik v farmakokinetičnih lastnostih zdravila ATryn pri nosečih in nenosečih bolnicah, ni mogoče podati priporočil za odmerjanje med nosečnostjo ali za obdobje pred in med porodom ter po porodu.
English: Do not use this medicine after the expiry date stated which is stated on the carton and vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: The most serious reported adverse reactions observed in clinical trials are haemorrhage and post procedural
Slovenian: Najresnejša neželena učinka, o katerih so poročali v kliničnih preskušanjih, sta krvavitev in krvavitev po opravljenem postopku.
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
English: Upon complete dissolution, the reconstituted product may be drawn up into a sterile disposable syringe.
Slovenian: Po popolni raztopitvi lahko rekonstituirano zdravilo napolnimo v sterilno brizgo za enkratno uporabo.
English: ATryn is supplied as a powder for solution for infusion (1750 IU powder in vial).
Slovenian: Zdravilo ATryn je na voljo kot prašek za raztopino za infundiranje (1750 i.e. prašek v viali).
English: In studies with ATryn the following side effects were reported: Common side effects (may affect up to 1 in 10 people) are:
Slovenian: V študijah z zdravilom ATryn so poročali o naslednjih neželenih učinkih: Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov):
English: If these symptoms occur after administration, they should contact their physician.
Slovenian: Če se po uporabi zdravila pojavijo ti znaki, se morajo obrniti na zdravnika.
English: The most commonly reported adverse reactions observed in clinical trials are dizziness, headache, haemorrhage, nausea, venipuncture site haemorrhage, post procedural haemorrhage and wound secretion.
Slovenian: Najpogosteje opisani neželeni učinki, opaženi v kliničnih preskušanjih, so omotica, glavobol, krvavitev, navzea, krvavitev na mestu venepunkcije, krvavitev po opravljenem postopku in izločanje iz rane.
English: Due date
Slovenian: Do datuma
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Prior to launch in any EU Member State, the MAH will set up a post-marketing surveillance programme to collect the following information about congenital AT deficient patients treated with ATryn
Slovenian: Spremljanje po začetku trženja a) Pred začetkom trženja v katerikoli državi članici EU bo imetnik dovoljenja za promet z zdravilom vzpostavil program za spremljanje zdravila po dajanju na trg z namenom zbiranja sledečih informacij o bolnikih s prirojenem pomanjkanjem antitrombina, zdravljenih z
English: b)
Slovenian: NN:
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with congenital antithrombin deficiency.
Slovenian: Zdravljenje mora potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s prirojenim pomanjkanjem antitrombina.
English: After reconstitution, 1 ml of solution contains 175 IU antithrombin alfa.
Slovenian: Po rekonstituciji 1 ml raztopine vsebuje 175 i.e. antitrombina alfa.
English: No information is available on the possible effects of antithrombin alfa on male and female fertility.
Slovenian: Podatkov o morebitnem vplivu antitrombina alfa na sposobnost razmnoževanja pri moških in ženskah ni.
English: Adverse reactions
Slovenian: Preobčutljivostne reakcije
English: In clinical trials involving congenital antithrombin deficient patients (n=35) one mild undesirable effect of “application site pruritis” was reported as related to treatment with ATryn.
Slovenian: Pri kliničnih preskušanjih na bolnikih s prirojenim pomanjkanjem antitrombina (n =35) se je ob zdravljenju z zdravilom ATryn pojavil blag neželen učinek “pruritus na mestu aplikacije”.
English: * potency (IU) determined using European Pharmacopoeial chromogenic assay.
Slovenian: * Jakost (i.e.) se določa z uporabo kromogenega testa po Evropski farmakopeji.
English: Initial treatment starts with a loading dose targeting an antithrombin activity level of 100%.
Slovenian: Začetno zdravljenje se začne z odmerkom, ki dvigne raven aktivnosti antitrombina na 100 %.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC,
English: ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of adult patients with congenital antithrombin deficiency.
Slovenian: Zdravilo ATryn se uporablja za profilakso venskega tromboembolizma pri operacijah odraslih bolnikov s prirojenim pomanjkanjem antitrombina.
English: For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte 6.1.
English: • feeling hot • infusion site reactions such as pain, bruising and redness
Slovenian: • reakcije na mestu infundiranja, kot so bolečina, modrica in rdečica.
English: The calculation of the required dosage of antithrombin alfa is based on pre-treatment plasma antithrombin activity and body weight.
Slovenian: Izračun potrebnega odmerka antitrombina alfa temelji na aktivnosti antitrombina v plazmi pred zdravljenjem in telesni masi.
English: The usual maintenance dose in surgical patients with congenital antithrombin deficiency in clinical risk situations is 4-5 IU/kg/h.
Slovenian: Običajni vzdrževalni odmerek pri operiranih bolnikih s prirojenim pomanjkanjem antitrombina v klinično nevarnih razmerah znaša 4-5 i.e./kg/h.
English: The active substance is antithrombin alfa*: 1750 IU.
Slovenian: Zdravilna učinkovina je antitrombin alfa*: 1750 i.e.
English: Thus, concurrent administration of antithrombin with heparin, low molecular weight heparin, or other anticoagulants that potentiate the anticoagulant activity of antithrombin to a patient with increased risk of bleeding must be monitored clinically and biologically.
Slovenian: Zato je treba hkratno uporabo antitrombina s heparinom, heparinom z nizko molekulsko maso ali drugimi antikoagulanti, ki okrepijo antikoagulantno aktivnost antitrombina, pri bolnikih s povečano nevarnostjo krvavenja nadzorovati klinično in biološko.
English: In case the AT activity level is between 80% and 120% (0.8 - 1.2 IU/ml), no dose adjustment is needed.
Slovenian: Če je raven aktivnosti antitrombina med 80 % in 120 % (0,8-1,2 i.e./ml), ni potrebno prilagajanje odmerka.
English: After the start of the maintenance dose infusion, blood for AT activity levels should be drawn at 45 minutes after the start of the loading dose infusion.
Slovenian: Po začetku infundiranja vzdrževalnega odmerka je treba odvzeti kri za preverjanje ravni aktivnosti antitrombina 45 minut po infundiranju začetnega odmerka.
English: Reconstitution/dilution
Slovenian: Rekonstitucija/redčenje
English: One vial contains nominally 1750 IU* antithrombin alfa**.
Slovenian: Ena viala vsebuje nominalno 1750 i.e.* antitrombina alfa**.
English: Laboratoire Français du Fractionnement et des Biotechnologies, 3 Avenue des Tropiques, ZA de
Slovenian: Laboratoire Français du Fractionnement et des Biotechnologies 3 Avenue des Tropiques
English: The following information is intended for healthcare professionals only: This medicine is intended for single use only.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu in farmacevtskemu osebju:
English: The vials should be used immediately and no longer than 3 hours after reconstitution.
Slovenian: Viale je treba uporabiti takoj in najkasneje v 3 urah po rekonstituciji.
English: ATryn 1750 IU powder for solution for infusion
Slovenian: ATryn 1750 i.e. prašek za raztopino za infundiranje
English: What you need to know before you use ATryn
Slovenian: Kaj je zdravilo ATryn in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ATryn
English: Therefore, an additional check of the AT activity level should be done after the surgery.
Slovenian: Zato je treba po operaciji opraviti dodatno preverjanje ravni aktivnosti antitrombina.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: The dose can be calculated utilizing the post-surgical AT activity in the loading dose formula above.
Slovenian: Odmerek se da izračunati s pomočjo pooperacijske aktivnosti antitrombina v zgornji formuli za začetni odmerek.
English: In case the activity level is below 80% a 15 minutes bolus infusion of AT can be given to quickly restore the AT activity level.
Slovenian: V primeru, da je raven aktivnosti pod 80 %, lahko opravite 15-minutno bolusno infundiranje antitrombina, da se raven aktivnosti antitrombina hitro povrne v prvotno stanje.
English: The reconstituted product should be inspected visually for particulate matter and/or discolouration prior to administration.
Slovenian: Rekonstituirano raztopino je treba pred uporabo preveriti na prisotnost delcev in/ali razbarvanje.
English: Limited clinical data are available on the use of antithrombin alfa in pregnant women.
Slovenian: Glede uporabe antitrombina alfa pri nosečnicah so na voljo le omejeni klinični podatki.
English: Adverse drug reactions including lack of efficacy Physicians should be encouraged to enrol patients in the surveillance programme and results of the surveillance should be provided in the update to the EU-RMP or at the time of the annual reassessment, whichever comes first.
Slovenian: • neželeni učinki, vključno z neučinkovitostjo, Zdravnike je treba spodbujati k vključevanju bolnikov v program spremljanja, rezultate spremljanja pa je treba vključiti v dopolnitve Načrta EU za upravljenje s tveganji ali predložiti ob vsakoletni ponovni b) Pred začetkom trženja v katerikoli državi članici EU bo imetnik dovoljenja za promet z zdravilom vzpostavil program nadziranja delovanja imunskega statusa in zdravnikom omogočil testiranje na protitelesa proti zdravilu ATryn.
English: No antibodies to antithrombin alfa have been detected up to 90 days following treatment with ATryn.
Slovenian: Do 90 dni po zdravljenju z zdravilom ATryn niso zaznali protiteles proti antitrombinu alfa.
English: It is possible that the surgical procedure will influence AT activity levels.
Slovenian: Operacijski postopek lahko vpliva na raven aktivnosti antitrombina.
English: The usual loading dose in surgical patients (baseline AT activity 50%, bodyweight 75 kg) with congenital antithrombin deficiency in clinical risk situations is 20-25 IU/kg bodyweight.
Slovenian: Običajni začetni odmerek pri operiranih bolnikih (osnovna aktivnost antitrombina 50 %, telesna masa 75 kg) s prirojenim pomanjkanjem antitrombina v klinično nevarnih razmerah znaša 20-25 i.e./kg telesne teže.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij LFB-BIOTECHNOLOGIES
English: The loading dose should be given as a 15 minute infusion immediately followed by initiation of the maintenance infusion.
Slovenian: Začetni odmerek je treba dati kot 15 minut trajajočo infuzijo, kateri takoj sledi vzdrževalna infuzija.
English: The therapeutic goal of treatment with antithrombin alfa is to increase to, and maintain antithrombin activity between 80 - 120% (0.8 - 1.2 IU/ml) for the duration of treatment.
Slovenian: Terapevtski namen zdravljenja z antitrombinom alfa je povečati in vzdrževati aktivnost antitrombina med 80-120 % (0,8-1,2 i.e./ml) v času zdravljenja.
English: LFB-BIOTECHNOLOGIES, 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France MedImmune Pharma BV Lagelandseweg 78 6545 CG Nijmegen, The Netherlands.
Slovenian: LFB-BIOTECHNOLOGIES, 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, Francija
English: In case the AT activity level is greater than 120% decrease the infusion rate by 30%.
Slovenian: Če je raven aktivnosti antitrombina večja od 120 %, zmanjšajte hitrost infuzije za 30 %.
English: Injury and poisoning and procedural complications Common
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih pogosti krvavitev po opravljenem postopku izločanje iz rane
English: The risk of diminution of antithrombin levels by prolonged treatment with a non-fractionated heparin should be
Slovenian: Upoštevati je treba nevarnost zmanjšanja ravni antitrombina s podaljšanim zdravljenjem z
English: The therapeutic goal of treatment with antithrombin alfa is to increase to, and maintain antithrombin activity between 80 - 120% of normal (0.8 - 1.2 IU/ml) for the duration of treatment.
Slovenian: Terapevtski namen zdravljenja z antitrombinom alfa je povečati in vzdrževati aktivnost antitrombina med normalno vrednostjo 80-120 % (0,8-1,2 i.e./ml) v času zdravljenja.
English: ** recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA
Slovenian: ** Rekombinantni humani antitrombin se proizvaja z rekombinantno DNA-tehnologijo (rDNA) v mleku transgenskih koz.
English: This antibody testing should be provided upon request of a physician and when the MAH receives a report suggestive of a possible immune
Slovenian: To testiranje na protitelesa je treba omogočiti na zahtevo zdravnika in kadar imetnik dovoljenja za promet z zdravilom dobi poročilo, značilno za morebitne imunske reakcije ali c) Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bo material, ki ga bodo prejeli zdravniki, vseboval informacije o programu spremljanja zdravila po dajanju na trg in o programu imunskega
English: In case the AT activity level is less than 80%, increase the maintenance infusion rate by 50%.
Slovenian: Če je raven aktivnosti antitrombina manjša od 80 %, povečajte hitrost vzdrževalne infuzije za 50 %.
English: Some additional data have been obtained from a number of patients in
Slovenian: Do dodatnih rezultatov so prišli pri številnih bolnikih, vključenih v program sočutne uporabe.
English: The reconstituted solution should be used immediately and no longer than 3 hours after reconstitution.
Slovenian: Rekonstituirane viale je treba uporabiti takoj in najkasneje v 3 urah po rekonstituciji.
English: SPECIAL STORAGE CONDITIONS
Slovenian: 6.4 Posebna navodila za shranjevanje
English: The contents of the syringes should be administered immediately and no longer than 3 hours after reconstitution.
Slovenian: Vsebino injekcijskih brizg je treba uporabiti takoj in najkasneje v 3 urah po rekonstituciji.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
English: Powder for solution for infusion (1750 IU)
Slovenian: Prašek za raztopino za infundiranje (1750 i.e.) 1 viala
English: - if you are allergic to antithrombin alfa or any of the other ingredients of this medicine (listed in section - if you are allergic to goat products as antithrombin alfa is produced in the milk of transgenic goats by
Slovenian: - če ste alergični na izdelke iz kozjega mleka, saj se antitrombin alfa proizvaja z rekombinantno DNA-tehnologijo (rDNA) v mleku transgenskih koz.
English: Nervous system disorders
Slovenian: Organski sistemi po MedDRA
English: * recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA
Slovenian: * Rekombinantni humani antitrombin se proizvaja s tehnologijo rekombinantne DNA (rDNA) v mleku transgenskih koz.
English: Normal sodium chloride solution 9 mg/ml (0.9%) may be added to dilute to a concentration convenient for
Slovenian: Da bo raztopina primerna za uporabo, jo lahko razredčite z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: This initial loading dose is based on body weight and on the pretreatment antithrombin activity level.
Slovenian: Začetni odmerek se določi glede na telesno težo in raven aktivnosti antitrombina pred zdravljenjem.
English: - Antithrombin levels should be measured daily, in order to adjust the individual dose.
Slovenian: Za prilagajanje posameznega odmerka morate dnevno meriti ravni antitrombina.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.. 6.3 Rok uporabnosti neodprte viale: 4 leta
English: Normal antithrombin activity in adults is 80 - 120% (0.8-1.2 IU/ml) and levels in neonates are about
Slovenian: Običajna aktivnost antitrombina pri odraslih je 80-120 % (0,8-1,2 i.e./ml), raven aktivnosti pri novorojenčkih pa je med 40-60 % (0,4-0,6 i.e./ml).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 28. julij 2006
English: Gastrointestinal disorders
Slovenian: Sočasna uporaba antikoagulantov
English: Package leaflet: Information for the user ATryn 1750 IU powder for solution for infusion antithrombin alfa (rDNA) This medicine is subject to additional monitoring.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE ATryn 1750 i.e. prašek za pripravo raztopine za infundiranje antitrombin alfa (rDNA) za intravensko uporabo
English: Detailed information on this product is available on the website of the European Medicines Agency
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: Klinična učinkovitost in varnost
English: Your treatment will be initiated under the supervision of a physician experienced in the care of patients with Your health care provider will prepare a solution of antithrombin alfa to be administered to you through your vein.
Slovenian: Vaše zdravljenje se bo začelo pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s prirojenim pomanjkanjem antitrombina.
English: Marketing Authorisation Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom
English: Feeling hot
Slovenian: Nalepka na viali
English: - Keep this leaflet.
Slovenian: Neodprte viale:
English: Common
Slovenian: Francija
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Slovenian: SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Slovenian: Izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Maintenance dose (IU/hour) = [(100 - patient's pre-treatment AT activity level in %) /10.22] x Body Weight in kg
Slovenian: Vzdrževalni odmerek (i.e./uro) = [(100 - raven aktivnosti antitrombina pri bolniku pred zdravljenjem v %) /10,22] x telesna teža v kilogramih
English: This includes any possible side effects not listed in this
Slovenian: MOŽNI NEŽELENI UČINKI
English: Loading dose (IU) = [(100 - patient's pre-treatment AT activity level in %) /2.28] x Body Weight in kg
Slovenian: Začetni odmerek (i.e.) = [(100 - raven aktivnosti antitrombina pri bolniku pred zdravljenjem v %) /2,28] x telesna teža v kilogramih
English: MedDRA SOC
Slovenian: ZA de Courtaboeuf
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: One vial contains nominally 1750 IU antithrombin alfa*.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje nominalno 1750 i.e. antitrombina alfa*.
English: Dizziness headache
Slovenian: Bolezni živčevja pogosti omotica glavobol