FrancophonIA/ELRC3.0 huggingface dataset:
English: Following discontinuation of NovoThirteen the patient's neutrophil count returned to levels similar to those prior to treatment with NovoThirteen.
Estonian: Pärast NovoThirteen-ravi katkestamist naasis patsiendi neutrofiilide arv NovoThirteen-ravi eelsele tasemele.
English: NovoThirteen may not be effective in patients with hepatic impairment if the hepatic impairment is severe enough to result in decreased levels of FXIII B-subunits.
Estonian: NovoThirteen ei pruugi olla efektiivne maksakahjustusega patsientidel, kui maksakahjustus on piisavalt tõsine, et põhjustada FXIII B-alaühiku taseme vähenemist.
English: If you use more NovoThirteen than you should
Estonian: Kui te kasutate NovoThirteen'i rohkem kui ette nähtud
English: The medicinal product contains less than 1 mmol sodium (23 mg) per injection, indicating that it is essentially ‘sodium free'.
Estonian: See ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) ühe süste kohta, seega on sisuliselt naatriumivaba.
English: NovoThirteen contains the active substance catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood clotting.
Estonian: NovoThirteen'i toimeaine on katridekakog, mis on identne inimese hüübimisfaktor XIII-ga ning on vajalik ensüüm vere hüübimiseks.
English: The excretion of rFXIII in milk has not been studied in animals.
Estonian: rFXIII eritumist rinnapiima ei ole loomadel uuritud.
English: In this trial the mean volume of distribution at steady state was 47 ml/kg, mean residence time was 15.5 days and mean clearance was 0.13 ml/kg.
Estonian: Selles uuringus oli keskmine jaotusruumala tasakaalu kontsentratsiooni juures 47 ml/kg, keskmine eritumisaeg (mean residence time, MRT) 15,5 päeva ning keskmine kliirens 0,13 ml/kg.
English: What you need to know before you use NovoThirteen
Estonian: Mida on vaja teada enne NovoThirteen'i kasutamist
English: Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.
Estonian: Puhastada viaalide kummikorgid alkoholis immutatud lappidega ning lasta korkidel enne kasutamist kuivada.
English: NovoThirteen is a recombinant coagulation factor XIII A-subunit produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Estonian: NovoThirteen on rekombinantne hüübimisfaktor XIII A-alaühik, mis on toodetud pärmirakkude (Saccharomyces cerevisiae) poolt rekombinantse DNA tehnoloogia abil.
English: Any residual material of the diluted product has to be discarded immediately.
Estonian: Kõik lahjendamise käigus tekkinud jäätmed tuleb hävitada viivitamatult.
English: Inject air into the vial by pushing the plunger until you feel a clear resistance.
Estonian: Süstige õhk viaali, lükates kolbi, kuni tunnete selgelt takistust.
English: There is limited clinical experience in administering NovoThirteen to elderly patients with congenital FXIII deficiency.
Estonian: Kliinilised kogemused NovoThirteen'i manustamisel eakatele FXIII kaasasündinud puudulikkusega patsientidele on piiratud.
English: The preparation should be administered as a slow bolus intravenous injection at a rate not higher than 2 ml/minute.
Estonian: Manustage preparaati aeglase veenisisese boolussüstena mitte kiiremini kui 2 ml minutis.
English: In plasma, FXIII circulates as a heterotetramer [A2B2] composed of 2 FXIII A-subunits and 2 FXIII Bsubunits held together by strong non-covalent interactions.
Estonian: Plasmas ringleb FXIII heterotetrameerina [A2B2], mis koosneb kahest FXIII A-alaühikust ja kahest FXIII B-alaühikust, mida hoiavad koos tugevad mittekovalentsed sidemed.
English: Analyses of data from paediatric patients included in clinical trials have not identified differences in treatment response according to age.
Estonian: Lastel saadud andmete, sh kliinilistest uuringutest saadud andmete analüüs ei ole näidanud east sõltuvaid erinevusi ravivastuses.
English: In a post-authorisation safety study transient non-neutralising antibodies were seen in a child with congenital FXIII deficiency after several years of treatment with NovoThirteen.
Estonian: Turuletulekujärgses ohutusuuringus leiti ühel kaasasündinud FXIII puudulikkusega lapsel pärast mitu aastat kestnud ravi NovoThirteen'iga lühiajaliselt esinenud mitteneutraliseerivad antikehad.
English: Treatment should be initiated under the supervision of a doctor experienced in the treatment of rare bleeding disorders.
Estonian: Ravi tuleb alustada harvaesinevate veritsushäirete ravis kogenud arsti järelevalve all.
English: NovoThirteen (A-subunit) binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to endogenous [A2B2].
Estonian: NovoThirteen (A-alaühik) seob inimese vaba FXIII B-alaühiku ning nii moodustub heterotetrameer [rA2B2], mille poolestusaeg on sarnane endogeense [A2B2] omale.
English: • Package Leaflet.
Estonian: • pakendi infoleht.
English: Safely dispose of the syringe, vial adapter, infusion set and vials.
Estonian: Hävitage süstal, viaali adapter, infusioonikomplekt ja viaalid ohutul viisil.
English: The crude bleeding rates in the two trials, F13CD-1725 and F13CD-3720, not adjusted for age, were 0.138 and 0.043 respectively, corresponding to a total of 13 bleeds over 223 subject-years and a pooled rate of 0.058.
Estonian: Uusi veritsusi nendes kahes uuringus (F13CD-1725 ja F13CD-3720) oli vanusele kohandamata vastavalt 0,138 ja 0,043, mis vastab kokku 13 veritsusele üle 223 patsiendiaasta kohta ja kogumäär
English: Twenty-one children between the age of 6 to less than 18 years old and six children less than 6 years old have been treated with NovoThirteen for a total of 986 exposures.
Estonian: Kahtekümmend ühte last vanuses 6 kuni 18 aastat ja kuut last (nooremad kui 6 aastat) raviti NovoThirteen'iga kokku 986 korral.
English: Do not take a double dose to make up for a forgotten dose.
Estonian: Ärge võtke ununenud annuse asendamiseks kahekordset annust.
English: General instructions for dilution
Estonian: Lahjendamise üldised juhised
English: Renal insufficiency Patients with renal insufficiency requiring dialysis have not been studied in clinical trials.
Estonian: Neerupuudulikkus Dialüüsi vajavaid neerupuudulikkusega patsiente pole kliinilistes uuringutes osalenud.
English: A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced cardiovascular model in cynomolgus monkey resulted in exaggerated pharmacology (thrombosis and death) at a lower dose level than when administering the individual compounds.
Estonian: Kardiovaskulaarsel mudelil loomkatses Macaca fascicularis'tega oli rXIII ja rVIIa kombineeritud ravi tagajärjeks ülemäärane farmakoloogiline toime (tromboos ja surm) väiksema annuse juures kui üksikute komponentide eraldi manustamisel.
English: The product is now ready for injection.
Estonian: Ravimpreparaat on nüüd süstimiseks valmis.
English: FXIII B-subunit deficiency is associated with a much reduced half-life of the administered pharmacologically active A-subunit.
Estonian: FXIII B-alaühiku puudulikkust seostatakse manustatud farmakoloogiliselt aktiivse A-alaühiku tugevalt vähenenud poolestusajaga.
English: The subunit deficiency of patients should be determined prior to treatment by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping.
Estonian: Alaühiku puudulikkus tuleb patsientidel kindlaks teha enne ravi alustamist sobivate diagnostiliste testide, sh XIII faktori aktiivsuse määramise, immuunanalüüsi ja võimalusel genotüübi määramisega.
English: 21 patients were between the age of 6 to less than 18 years old and 6 patients were less than 6 years old (total of 986 exposures of NovoThirteen in paediatric subjects (less than 18 years old).
Estonian: 21 patsienti olid vanuses 6 kuni 18 aastat ja 6 patsienti nooremad kui 6 aastat (kokku kasutati NovoThirteen'i (noorematel kui 18-aastastel) lastel 986 korral.)
English: In clinical trials, NovoThirteen has been administered to 82 patients with congenital factor XIII Asubunit deficiency (3112 doses of NovoThirteen).
Estonian: NovoThirteen'i manustati kliinilistes uuringutes 82-le faktor XIII A-alaühiku kaasasündinud puudulikkusega patsiendile (3112 annust NovoThirteen'i).
English: If you forget to use NovoThirteen
Estonian: Kui te unustate NovoThirteen'i kasutada
English: The results of standard coagulation tests are normal, as it is the quality of the clot that is affected.
Estonian: Standardsete hüübimistestide tulemused on normaalsed, kuna FXIII puudulikkuse puhul on häiritud trombi kvaliteet.
English: Based on FXIII activity measured by the Berichrom assay in patients with congenital FXIII deficiency, a geometric mean half-life of 11.8 days was estimated.
Estonian: FXIII aktiivsus määrati kaasasündinud FXIII puudulikkusega patsientidel Berichrom analüüsiga, mille alusel poolestusaja geomeetriliseks keskmiseks hinnati 11,8 päeva.
English: These antibodies were seen at the start of treatment with NovoThirteen.
Estonian: Mitteneutraliseerivad antikehad tekkisid NovoThirteen-ravi alguses.
English: The half-life of NovoThirteen was assessed in the F13CD-1725 trial from a limited blood sampling scheme at 1 hour, 14 and 28 days post dose.
Estonian: Uuringus F13CD-1725 määrati NovoThirteen'i poolestusaeg piiratud arvust vereproovidest, mis olid kogutud 1 tund, 14 ja 28 päeva pärast annuse manustamist.
English: Children above 6 years were investigated through the pivotal phase 3 trial (F13CD-1725) and the extension study (F13CD-3720) assessing the safety of monthly replacement therapy with NovoThirteen.
Estonian: Üle 6-aastaseid lapsi uuriti olulises III faasi uuringus (F13CD-1725) ja jätku-uuringus (F13CD-3720), et hinnata igakuise NovoThirteen-asendusravi ohutust.
English: • The risks of off-label use within FXIII congenital deficiency
Estonian: • väljaspool kinnitatud näidustust kasutamise risk FXIII kaasasündinud puudulikkuse korral;
English: Hold the syringe slightly tilted with the vial facing downwards.
Estonian: Hoidke süstalt veidi kallutatult, nii et viaal oleks suunatud allapoole.
English: What NovoThirteen contains
Estonian: Mida NovoThirteen sisaldab
English: When the FXIII Asubunit is bound to the FXIII B-subunit [A2B2], the half-life of the FXIII A-subunit [A2] is prolonged.
Estonian: Kui FXIII A-alaühik on seotud FXIII B-alaühikuga [A2B2], siis FXIII A-alaühiku [A2] poolestusaeg pikeneb.
English: There are no human data on potential effects on fertility.
Estonian: Võimaliku toime kohta fertiilsusele ei ole andmeid inimestelt.
English: In the primary endpoint analysis covering the referred period, the age-adjusted rate (number per subject year) of treatment-requiring bleeds during the rFXIII treatment period was 0.048/year (95% CI: 0.009 - 0.250; model-based estimate corresponding to the mean age of 26.4 years for the 41 patients).
Estonian: Esmase tulemusnäitaja analüüs näitas, et rFXIII ravi ajal esines 0,048 ravi vajavat verejooksu juhtu aastas (kohandatud vanusele; 95% usaldusvahemik: 0,009-0,250; mudelipõhine hinnang uuringus osalenud 41 patsiendi põhjal, kelle keskmine vanus oli 26,4 aastat).
English: The 6 patients below 6 years were investigated through a single dose pharmacokinetic phase 3b trial (F13CD-3760) and then, included in the long-term follow-up trial (F13CD-3835) assessing the safety and the efficacy of monthly replacement therapy with NovoThirteen.
Estonian: Kuut alla 6-aastast patsienti uuriti ühe annuse farmakokineetika IIIb faasi uuringus (F13CD-3760) ja seejärel pikaaegses jätku-uuringus (F13CD-3835), et hinnata igakuise NovoThirteen-asendusravi ohutust ja efektiivsust.
English: Patients with hepatic impairment have not been studied.
Estonian: Maksakahjustusega patsiente pole uuritud.
English: Do not shake the vial as this will cause foaming.
Estonian: Ärge raputage viaali, sest see põhjustab vahu teket.
English: In case of predisposition to conditions of thrombosis, caution should be exercised due to the fibrinstabilising effect of NovoThirteen.
Estonian: Juhul kui patsiendil on eelsoodumus tromboosi tekkeks, tuleb NovoThirteen'i kasutamisel ettevaatlik olla, sest ravimil on fibriini stabiliseeriv toime.
English: Follow the injection procedure as instructed by your doctor.
Estonian: Järgige süsteprotseduuri käigus arsti antud juhiseid.
English: FXIII activity levels should be monitored in patients with severe hepatic impairment.
Estonian: Tõsise maksakahjustusega patsientidel tuleb FXIII aktiivsustasemeid jälgida.
English: The FXIII B-subunit acts as a carrier molecule for the FXIII A-subunit in circulation, and is present in excess in plasma.
Estonian: FXIII B-alarühm käitub vereringes FXIII A-alaühiku kandjana ning seda leidub plasmas küllaldaselt.
English: Reconstituted NovoThirteen is a clear, colourless solution.
Estonian: Lahustunud NovoThirteen on selge värvitu lahus.
English: A stabilisation of the thrombus might occur, resulting in increased risk of vessel occlusions.
Estonian: Trombi stabiliseerimise tagajärjel võib suureneda veresoonte ummistumise risk.
English: In clinical studies, adverse reactions were more frequently reported in patients aged from 6 to less than 18 years old than in adults.
Estonian: Kliiniliste uuringute käigus teatati 6…18-aastastel patsientidel esinenud kõrvaltoimetest sagedamini kui teistes vanuserühmades.
English: It is not recommended to use NovoThirteen and recombinant coagulation factor VIIa (another blood clotting factor) together.
Estonian: NovoThirteen'i ja rekombinantset hüübimisfaktorit VIIa-d (üks teine vere hüübimisfaktor) ei ole soovitatav koos kasutada.
English: The congenital factor XIII A-subunit deficiency should be confirmed by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping.
Estonian: Faktor XIII Aalaühiku kaasasündinud puudulikkust peavad olema kinnitanud sobivad diagnostilised testid, sh faktor XIII aktiivsuse määramine, immuunanalüüs ja võimalusel genotüübi määramine.
English: Non-neutralising antibodies have been seen in 4 of the 82 exposed patients with congenital FXIII deficiency.
Estonian: Mitteneutraliseerivaid antikehi täheldati neljal FXIII kaasasündinud puudulikkusega patsiendil 82-st.
English: The antibodies had no inhibitory action and the patients did not experience any adverse events or bleeding in association with these antibodies.
Estonian: Antikehad ei toiminud inhibiitoritena ning patsientidel ei esinenud antikehadega seoses kõrvalnähtusid ega veritsemist.
English: The active transglutaminase cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot and contributes to enhanced platelet and clot adhesion to the injured tissue.
Estonian: Aktiivne FXIII A-alaühik (transglutaminaas ) seob ristühenduse abil fibriini ja teised valgud, mille tagajärjel fibriinikämbu mehaaniline tugevus suureneb ja see muutub fibrinolüüsi suhtes vastupidavamaks ning soodustab vereliistakute ja trombi kleepumist kahjustatud koele.
English: What NovoThirteen looks like and contents of the pack NovoThirteen is supplied as a powder and solvent for solution for injection (2500 IU powder in a vial and 3.2 ml solvent in a vial, with a vial adapter).
Estonian: Kuidas NovoThirteen välja näeb ja pakendi sisu NovoThirteen on saadaval süstelahuse pulbri ja lahustina (2500 RÜ pulbrit viaalis ja 3,2 ml lahustit viaalis ning viaali adapter).
English: What NovoThirteen is and what it is used for
Estonian: Mis ravim on NovoThirteen ja milleks seda kasutatakse
English: No dose adjustment is required when NovoThirteen is used in paediatric patients and the dose of 35 IU/kg body weight should be used (see section 5.2 ‘Paediatric population').
Estonian: Lastel ei ole annuse kohandamine vajalik ja kasutama peaks annust 35 RÜ/kg kehakaalu kohta (vt lõik 5.2 „Lapsed“).
English: This is in agreement with the elimination pharmacokinetics estimated from a clinical pharmacology trial in healthy subjects, which determined the half-life to be 11.8 days.
Estonian: See vastab tervete katsealustega tehtud kliinilises uuringus saadud tulemusele, kus poolestusaeg oli 11,8 päeva.
English: Powder (2500 IU) in a vial (glass type I) with rubber stopper (chlorobutyl) and 3.2 ml solvent in a vial (glass type I) with rubber stopper (bromobutyl) and a vial adapter for reconstitution.
Estonian: Pulber (2500 RÜ) kummikorgiga (klorobutüül) viaalis (1. tüüpi klaas) ja 3,2 ml lahustit kummikorgiga (bromobutüül) viaalis (1. tüüpi klaas) ja viaali adapter lahuse valmistamiseks.
English: This dose adjustment should be based on FXIII activity levels.
Estonian: Sel juhul tuleb annust kohandada vastavalt FXIII aktiivsusele.
English: Once prepared, NovoThirteen for injection should be used immediately.
Estonian: Kui NovoThirteen on ette valmistatud, tuleb see kohe süstida.
English: • Contraindication of hypersensitivity
Estonian: • ülitundlikkuse vastunäidustus;
English: The recommended dose is 35 IU/kg body weight (bw) once monthly (every 28 days ± 2 days), administered as an intravenous bolus injection.
Estonian: Soovitatav annus on 35 RÜ/kg kehakaalu kohta manustatuna kord kuus (iga 28 päeva ± 2 päeva tagant) veenisisese boolussüstena.
English: Inhibitors may be suspected in the event of lack of therapeutic response which is observed as bleeding or demonstrated by laboratory findings including FXIII activity that fails to reach expected levels.
Estonian: Kui ei saavutata terapeutilist vastust, näiteks esineb veritsusi või laboratoorsed analüüsid ei näita FXIII aktiivsuse oodatud taset, tuleks kahtlustada inhibiitorite teket.
English: The mean rate of treatment-requiring bleeds was determined to 0.138 per subject year.
Estonian: Ravi vajavaid verejookse oli keskmiselt 0,138 juhtu ühe patsiendiaasta kohta.
English: Patients should be informed of the early signs of hypersensitivity reactions (including hives, generalised urticaria, tightness of the chest, wheezing, hypotension) and anaphylaxis.
Estonian: Patsiente tuleks teavitada anafülaksia ja ülitundlikkusreaktsioonide varastest tunnustest (k.a lööve, laialt levinud urtikaaria, pitsitustunne rinnus, vilistav hingamine, madal vererõhk).
English: Powder: Sodium chloride, sucrose, polysorbate 20, L-histidine, hydrochloric acid, sodium hydroxide Solvent: water for injections
Estonian: Pulber: naatriumkloriid, sahharoos, polüsorbaat 20, histidiin, vesinikkloriidhape, naatriumhüdroksiid Lahusti: süstevesi.
English: After reconstitution, the medicinal product should be used immediately due to the risk of microbiological contamination.
Estonian: Pärast manustamiskõlblikuks muutmist kasutage ravim mikrobioloogilise saastatuse vältimiseks kohe ära.
English: Dose adjustment can be considered necessary by the physician in certain situations where the prevention of bleeding is not appropriately covered by the recommended 35 IU/kg/month dose.
Estonian: Arst võib kaaluda annuse kohandamist, kui soovitatud annus 35 RÜ/kg/kuus ei ole piisav veritsuste preventsiooniks.
English: In the F13CD-1725 extension trial F13CD-3720, the age-adjusted rate of bleeds that required treatment with a FXIII-containing product was estimated to be 0.021 bleeds per subject year with a 95% CI of [0.0062; 0.073] (model-based estimate corresponding to a mean age of the trial population of 31.0 years).
Estonian: Uuringu F13CD-1725 jätku-uuringus F13CD-3720 oli vanusele kohandatud veritsusi, mis vajasid ravi FXIII sisaldava ravimiga, hinnanguliselt 0,021 veritsust patsiendiaasta kohta, 95% usaldusvahemik [0,0062; 0,073] (mudelipõhine hinnang vastavalt patsientide keskmisele vanusele 31,0 aastat).
English: The signs may include: hives, itching, swelling, difficulty breathing, low blood pressure (signs include paleness and coldness of skin, rapid heartbeat), feeling dizzy and sweating.
Estonian: Hingamisraskused, madal vererõhk (kahvatus ja külm nahk, kiire südame löögisagedus), peapööritus ja higistamine.
English: Your treatment with NovoThirteen should be initiated by a doctor experienced in the treatment of rare bleeding disorders.
Estonian: NovoThirteen-ravi tuleb alustada harvaesinevate veritsushäirete ravis kogenud arsti järelevalve all.
English: Common (≥ 1/100 to < 1/10) Common (≥ 1/100 to < 1/10)
Estonian: Sage (≥ 1/100 kuni < 1/10) Sage (≥ 1/100 kuni < 1/10)
English: • The other ingredients are for the powder sodium chloride, sucrose and polysorbate 20, L-histidine, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH adjustment) and for the solvent water for injections.
Estonian: • Teised pulbri koostisosad on naatriumkloriid, sahharoos ja polüsorbaat 20, histidiin, vesinikkloriidhape (pH reguleerimiseks), naatriumhüdroksiid (pH reguleerimiseks).
English: Do not use NovoThirteen
Estonian: Ärge kasutage NovoThirteen'i:
English: The product is now ready for injection in the vein.
Estonian: Ravimpreparaat on nüüd veeni süstimiseks valmis.
English: To reconstitute and administer this product the following tools are needed: a 10 ml syringe or a syringe of a convenient size according to injection volume, alcohol swabs, the included vial adapter and an infusion set (tubing, butterfly needle).
Estonian: Ravimpreparaadi manustamiskõlblikuks muutmiseks ja manustamiseks on vaja järgmisi vahendeid: 10 ml süstalt või süstelahuse kogusele vastavas suuruses süstalt, alkoholiga immutatud lappe, komplektis olevat viaaliadapterit ja infusioonikomplekti (voolikut, libliknõela).
English: Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
Estonian: Eemaldage viaali adapterilt kaitsepaber viaali adapterit kaitsepakendist välja võtmata.
English: If you stop using NovoThirteen
Estonian: Kui te lõpetate NovoThirteen'i kasutamise
English: For instructions on reconstitution of the medicinal product prior to administration, see section 6.6.
Estonian: Ravimpreparaadi manustamiseelse lahustamise juhised vt lõik 6.6.
English: If you are not sure, ask your doctor before using this medicine.
Estonian: Kahtluse korral pidage enne ravimi kasutamist nõu oma arstiga.
English: Push the plunger slowly to inject the solvent into the powder vial.
Estonian: Lükake aeglaselt kolbi, et lahustit pulbri viaali süstida.
English: To dilute the reconstituted NovoThirteen the following tools are needed: a vial containing sodium chloride 0.9%, solution for injection, a 10 ml syringe and alcohol swabs.
Estonian: Manustamiskõlblikuks muudetud NovoThirteen'i lahjendamiseks on vajalikud järgmised vahendid: viaal 0,9% naatriumkloriidi süstelahusega, 10 ml süstal ja alkoholiga niisutatud lapikesed.
English: Long term prophylactic treatment of bleeding in patients with congenital factor XIII A-subunit deficiency.
Estonian: Verejooksude pikaaegne profülaktika kaasasündinud XIII hüübimisfaktori A-alaühiku puudulikkusega patsientidel.
English: What NovoThirteen is used for
Estonian: Milleks NovoThirteen'i kasutatakse
English: The antibodies had no inhibitory activity, and the subject did not experience any adverse events or bleeding in association with these antibodies.
Estonian: Antikehad ei toiminud inhibiitoritena ning patsiendil ei esinenud antikehadega seoses kõrvalnähtusid ega veritsemist.
English: No effects on reproductive organs were noted in the repeated dose toxicity studies.
Estonian: Korduvtoksilisuse uuringutes pole täheldatud mõju reproduktiivorganitele.
English: NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (rDNA factor XIII)
Estonian: RAVIMPREPARAADI NIMETUS NovoThirteen 2500 RÜ süstelahuse pulber ja lahusti catridecacogum (rDNA faktor XIII)
English: Upon activation, the FXIII A-subunit dissociates from the FXIII B-subunit and thereby exposes the active site of the FXIII A-subunit.
Estonian: Pärast aktiveerumist eraldub FXIII A-alaühik FXIII B-alaühikust ning vabastab FXIII A-alaühiku aktiivtsentri.
English: Based on the concentration of NovoThirteen solution, the dose volume to be injected (in millilitres) can be calculated from this formula:
Estonian: NovoThirteen'i lahuse kontsentratsiooni järgi saab manustamiseks vajaliku annuse mahu (milliliitrites) arvutada alltoodud valemi abil:
English: NovoThirteen is given as an injection into a vein.
Estonian: NovoThirteen'i süstitakse veeni.