FrancophonIA/ELRC3.0 huggingface dataset:
English: Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
Slovenian: Z nastavka za vialo odstranite zaščitni papir, vendar nastavka ne vzemite iz zaščitnega pokrovčka.
English: There is limited information on overdose with NovoThirteen.
Slovenian: Informacij o prevelikem odmerjanju zdravila NovoThirteen je malo.
English: Upon activation, the FXIII A-subunit dissociates from the FXIII B-subunit and thereby exposes the active site of the FXIII A-subunit.
Slovenian: Po aktivaciji se podenota A FXIII loči od podenote B in tako izpostavi aktivno mesto podenote A.
English: Incorrect storage of the product after reconstitution must be avoided as it may result in loss of sterility and in increased levels of non-proteolytically activated NovoThirteen.
Slovenian: Pripravljeno zdravilo je treba shranjevati pravilno, ker sicer lahko postane nesterilno, poleg tega pa se poveča količina neproteolitično aktiviranega zdravila NovoThirteen.
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.
Slovenian: Groba, za starost nekorigirana deleža krvavitev v preskušanjih F13CD-1725 in F13CD-3720 sta bila 0,138 v prvem in 0,043 v drugem; to ustreza skupnemu številu 13 krvavitev v 223 preiskovanec-letih in kumulativnemu deležu 0,058.
English: The product is now ready for injection in the vein.
Slovenian: Zdravilo je zdaj pripravljeno za injiciranje v veno.
English: No effects on reproductive organs were noted in the repeated dose toxicity studies.
Slovenian: V študijah toksičnosti ponavljajočih se odmerkov niso ugotovili učinkov na reproduktivne organe.
English: How to use NovoThirteen
Slovenian: Kako uporabljati zdravilo NovoThirteen
English: The active substance is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Slovenian: Učinkovina je pridobljena iz kvasovk (Saccharomyces cerevisiae) s tehnologijo rekombinantne DNA
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.
Slovenian: • Druge sestavine zdravila v prašku so natrijev klorid, saharoza, polisorbat 20, L-histidin, klorovodikova kislina (za uravnavanje pH) ter natrijev hidroksid (za uravnavanje pH).
English: Any residual material of the diluted product has to be discarded immediately.
Slovenian: Ves morebitni preostanek razredčenega zdravila morate takoj zavreči.
English: The dose volume for the reconstituted NovoThirteen diluted with 6 ml sodium chloride 0.9%, solution for injection can be calculated from this formula:
Slovenian: Velikost odmerka pripravljenega zdravila NovoThirteen, razredčenega s 6,0 ml 0,9 % raztopine natrijevega klorida za injiciranje, je mogoče izračunati po naslednji formuli:
English: A clot solubility assay is widely used as an indicator of FXIII deficiency, but the assay is qualitative, and when performed correctly the test is positive only when the FXIII activity in the sample is close to zero.
Slovenian: Vendar je ta preizkus kvalitativen in če je opravljen pravilno, je pozitiven le v primerih, ko je aktivnost FXIII v vzorcu skoraj nična.
English: No clinical findings were associated with these antibodies.
Slovenian: Pojav teh protiteles ni bil povezan s kliničnimi ugotovitvami.
English: There are no clinical data available on interaction between NovoThirteen and other medicinal products.
Slovenian: O medsebojnem delovanju zdravila NovoThirteen in drugih zdravil ni kliničnih podatkov.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA)
English: Hold the syringe slightly tilted with the vial facing downwards.
Slovenian: Držite brizgo rahlo nagnjeno, tako da je vstavljena viala spodaj.
English: • If you experience bleeding during your treatment with NovoThirteen occurring spontaneously and/or requiring treatment.
Slovenian: Nemudoma se posvetujte z zdravnikom: • če se vam med zdravljenjem z zdravilom NovoThirteen pojavi spontana krvavitev in/ali krvavitev zahteva zdravljenje.
English: Check the injection solution for particulate matter and for discolouration.
Slovenian: Preverite, da raztopina za injiciranje ne vsebuje delcev in da ni obarvana.
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).
Slovenian: Za pripravo in dajanje tega zdravila boste potrebovali: eno 10-ml brizgo (ali brizgo primerne velikosti glede na količino, ki jo morate injicirati), alkoholne zložence, priloženi nastavek za vialo in infuzijski komplet (cevke, iglo z metuljčkom).
English: Your treatment with NovoThirteen should be initiated by a doctor experienced in the treatment of rare bleeding disorders.
Slovenian: Vaše zdravljenje mora predpisati zdravnik, ki ima izkušnje z zdravljenjem redkih motenj strjevanja krvi.
English: The Marketing Authorisation Holder (MAH) shall ensure that, at launch, a letter is sent to all expected and actual prescribers of NovoThirteen with an Educational Pack containing the following: Physician brochure Patient brochure
Slovenian: Imetnik dovoljenja za promet bo zagotovil, da bo ob prihodu zdravila na trg vsem zdravnikom, ki predpisujejo zdravilo NovoThirteen in za katere se pričakuje, da ga bodo predpisovali, poslano pismo z izobraževalnim kompletom.
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.
Slovenian: Za razredčenje pripravljenega zdravila NovoThirteen so potrebni naslednji pripomočki: viala, ki vsebuje 0,9 % raztopino natrijevega klorida za injiciranje, 10-ml brizga in alkoholni zloženci.
English: No effects on reproductive organs have been seen in non-clinical studies.
Slovenian: Plodnost V nekliničnih študijah niso ugotovili vplivov na reproduktivne organe.
English: This dose adjustment should be based on FXIII activity levels.
Slovenian: Prilagoditev odmerka se mora opirati na raven aktivnosti faktorja XIII.
English: Dose volume in millilitres = 0.042 x your body weight in kilograms.
Slovenian: odmerek v mililitrih = 0,042 x vaša telesna masa v kilogramih.
English: The antibodies had no inhibitory action and the patients did not experience any adverse events or bleeding in association with these antibodies.
Slovenian: Ta protitelesa pri bolniku niso delovala zaviralno in preiskovanec v zvezi s temi protitelesi ni imel neželenih učinkov ali krvavitev.
English: NovoThirteen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Slovenian: Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
English: NovoThirteen is a recombinant coagulation factor XIII A-subunit produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Slovenian: Zdravilo NovoThirteen je podenota A rekombinantnega koagulacijskega faktorja XIII, pridobljenega v kvasovkah (Saccharomyces cerevisiae) s tehnologijo rekombinantne DNA.
English: Click the vial adapter, still attached to the syringe onto the powder vial.
Slovenian: S klikom pritrdite nastavek za vialo, ki je še vedno nameščen na brizgo, na vialo s praškom.
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).
Slovenian: V F13CD-1725, podaljšanju preskušanja F13CD-3720, je bil ocenjeni za starost korigirani delež krvavitev, ki so zahtevale zdravljenje z zdravili s FXIII, 0,021 krvavitve na preiskovanca na leto (95 % interval zaupanja: od 0,0062 do 0,073) (ocena na podlagi modela, ki ustreza povprečni starosti populacije v preskušanju 31,0 let).
English: • Embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis
Slovenian: • embolične in trombembolične dogodke, vključno z večjim tveganjem za zaporo žile pri bolnikih, ki imajo tveganje za trombozo • kako ukrepati v primeru nepravilnega shranjevanja, tromboze ali embolije
English: Push the plunger slowly to inject the solvent into the powder vial.
Slovenian: Počasi potiskajte bat in tako vbrizgajte vehikel v vialo s praškom.
English: DK-2880 Bagsværd
Slovenian: DK-2820 Gentofte Danska
English: Once prepared, NovoThirteen for injection should be used immediately.
Slovenian: Ko je zdravilo NovoThirteen pripravljeno za injiciranje, ga je treba takoj uporabiti.
English: It is structurally identical to the human FXIII A-subunit [A2].
Slovenian: Po zgradbi je identična podenoti A človeškega FXIII [A2].
English: INFORMATION IN BRAILLE NovoThirteen
Slovenian: PODATKI V BRAILLOVI PISAVI
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology and repeated dose toxicity.
Slovenian: Na osnovi študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih neklinični podatki ne kažejo posebnega tveganja za ljudi.
English: NovoThirteen is given as an injection into a vein.
Slovenian: Zdravilo NovoThirteen se injicira v veno.
English: For instructions on reconstitution of the medicinal product prior to administration, see section 6.6.
Slovenian: Za navodila o pripravi zdravila pred uporabo glejte poglavje 6.6. 4.3 Kontraindikacije
English: What NovoThirteen is and what it is used for
Slovenian: Kaj je zdravilo NovoThirteen in za kaj ga uporabljamo Kaj je zdravilo NovoThirteen
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.
Slovenian: Mehanizem delovanja V plazmi FXIII kroži kot heterotetramer [A2B2], sestavljen iz 2 podenot A in 2 podenot B FXIII,
English: In patients with FXIII deficiency, NovoThirteen is not effective if used for monthly prophylactic treatment of bleeding in patients with congenital FXIII B-subunit deficiency.
Slovenian: Zdravilo NovoThirteen ni učinkovito kot mesečno profilaktično zdravljenje pri bolnikih s pomanjkanjem FXIII, ki imajo prirojeno pomanjkanje podenote B FXIII.
English: In a pharmacokinetic trial 6 children (age 1 to less than 6 years old) with congenital FXIII A-subunit deficiency were exposed to one single i.v.
Slovenian: Pediatrična populacija V farmakokinetičnem preskušanju je 6 otrok (starih med 1 in 6 let) s prirojenim pomanjkanjem podenote A FXIII prejelo en intravenski odmerek 35 i.e./kg zdravila NovoThirteen.
English: The solution is clear and colourless.
Slovenian: Raztopina je bistra in brezbarvna.
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.
Slovenian: Zdravnik lahko v redkih primerih, če preprečevanje krvavitev ni ustrezno doseženo s priporočenim odmerkom 35 i.e./kg/mesec, presodi, da je treba odmerek prilagoditi.
English: Five bleeding episodes requiring treatment with a FXIII-containing product have been observed in four patients during treatment with rFXIII in the trial.
Slovenian: V preskušanju so med zdravljenjem z rFXIII pri štirih bolnikih zabeležili pet krvavitev, ki so zahtevale zdravljenje z zdravilom s FXIII.
English: In the event that inhibitors are suspected analysis for antibodies should be performed.
Slovenian: V primeru suma na zaviralce je treba opraviti analizo glede protiteles.
English: Attach the vial adapter to the solvent vial (water for injections).
Slovenian: Nastavek za vialo namestite na vialo z vehiklom (voda za injekcije).
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).
Slovenian: Zdravilo NovoThirteen je na voljo kot prašek in vehikel za raztopino za injiciranje (2500 i.e. praška v viali in 3,2 ml vehikla v viali, z nastavkom za vialo).
English: One healthy subject developed low-titer, transient non-neutralising antibodies after receiving the first dose of NovoThirteen.
Slovenian: Enemu zdravemu preiskovancu se je po prvem odmerku zdravila NovoThirteen prehodno pojavil nizek titer nenevtralizirajočih protiteles.
English: NovoThirteen is used to prevent bleeding in patients who do not have enough or are missing part of factor XIII (that is called A-subunit).
Slovenian: Za kaj uporabljamo zdravilo NovoThirteen Zdravilo NovoThirteen uporabljamo za preprečevanje krvavitev pri bolnikih, ki jim primanjkuje ali nimajo dela faktorja XIII, imenovanega podenota A.
English: • The active substance is catridecacog (recombinant coagulation factor XIII: 2500 IU/3 ml, after reconstitution, corresponding to a concentration of 833 IU/ml.
Slovenian: • Učinkovina je katridekakog (rekombinantni koagulacijski faktor XIII): 2500 i.e./3 ml, kar po pripravi ustreza koncentraciji 833 i.e./ml.
English: Thromboembolic risk:
Slovenian: Tveganje za trombembolične dogodke
English: Use in children and adolescents (weighing more than 24 kg) NovoThirteen can be used in children and adolescents in the same way as in adults.
Slovenian: Zdravilo NovoThirteen se lahko pri mladostnikih in otrocih uporablja na enak način kot pri odraslih.
English: What NovoThirteen contains
Slovenian: Kaj vsebuje zdravilo NovoThirteen
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.
Slovenian: Preden se začne zdravljenje pri bolnikih, je torej treba določiti, katera podenota FXIII bolniku primanjkuje z ustreznimi diagnostičnimi postopki, vključno z merjenjem aktivnosti FXIII in imunološkim preizkusom ter z genotipizacijo, če pride v poštev.
English: Carefully draw exactly 6 ml sodium chloride 0.9%, solution for injection, into the 10 ml syringe.
Slovenian: Previdno izvlecite 6 ml 0,9 % raztopine natrijevega klorida za injiciranje v 10-ml brizgo.
English: Four cases of non-neutralising antibodies were reported at the start of the treatment in patients from 6 to 18 years of age.
Slovenian: Pri bolnikih, starih med 6 in 18 let, so na začetku zdravljenja opazili štiri primere pojava nenevtralizirajočih protiteles.
English: In case a dilution of the reconstituted NovoThirteen is needed proceed to the section ‘Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection'.
Slovenian: Če je treba pripravljeno zdravilo NovoThirteen razredčiti, pojdite na poglavje "Razredčenje pripravljenega zdravila z 0,9 % raztopino natrijevega klorida za injiciranje".
English: Dose volume in ml = 0.042 x subject bw (kg)
Slovenian: velikost odmerka v ml = 0,042 x bolnikova telesna masa (kg)
English: No treatment requiring bleeding episodes have been detected in patients below 6 years during 17 years of cumulative follow-up, representing a total of 214 doses.
Slovenian: Pri bolnikih, mlajših od 6 let, med 17 let trajajočim kumulativnim spremljanjem (to pomeni v celoti 214 odmerkov) niso zabeležili epizod krvavitev, ki bi zahtevale zdravljenje.
English: Powder and solvent for solution for injection 2500 IU powder in a vial, 3.2 ml solvent in a vial, 1 vial adapter
Slovenian: prašek in vehikel za raztopino za injiciranje 2500 i.e. praška v viali 3,2 ml vehikla v viali nastavek za vialo za pripravo zdravila
English: NovoThirteen user instructions
Slovenian: Navodila za uporabnika zdravila NovoThirteen
English: FXIII activity levels should be monitored in patients with severe hepatic impairment.
Slovenian: Bolnikom s hudo boleznijo jeter je treba spremljati raven aktivnosti FXIII.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for powder vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: • Pain where the injection is given
Slovenian: • bolečina na mestu injiciranja
English: Slowly inject the 6 ml sodium chloride 0.9%, solution for injection, into the reconstituted NovoThirteen vial.
Slovenian: Počasi injicirajte 6 ml 0,9 % raztopine natrijevega klorida za injiciranje v vialo s pripravljenim zdravilom NovoThirteen.
English: However, if the paediatric patient weighs less than 24 kg, the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to handle the dosing of small children (see section 6.6 ‘Special precautions for disposal and other handling - Use in the paediatric population').
Slovenian: Toda če pediatrični bolnik tehta manj kot 24 kg, je treba pripravljeno zdravilo NovoThirteen za ustrezno odmerjanje pri majhnih otrocih dodatno razredčiti s 6 ml 0,9 % raztopine natrijevega klorida za injiciranje (glejte poglavje 6.6, "Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom - Uporaba pri pediatrični populaciji").
English: Before you can use NovoThirteen for injection you need to reconstitute the product.
Slovenian: Preden se zdravilo NovoThirteen uporabi za injiciranje, ga je treba pripraviti.
English: Remove the empty solvent vial by tipping the syringe with the vial adapter.
Slovenian: Odstranite prazno vialo z vehiklom, tako da nagnete brizgo skupaj z nastavkom za vialo.
English: Once attached, remove the protective cap from the vial adapter.
Slovenian: Ko je nastavek za vialo nameščen, z njega odstranite zaščitni pokrovček.
English: NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (recombinant coagulation factor XIII)
Slovenian: Navodilo za uporabo NovoThirteen 2500 i.e. prašek in vehikel za raztopino za injiciranje katridekakog (rekombinantni koagulacijski faktor XIII)
English: Pull the plunger to draw in a volume of air equal to the total amount of solvent in the solvent vial.
Slovenian: Izvlecite bat brizge, da boste vanjo potegnili toliko zraka, kolikor je vehikla v viali z vehiklom.
English: Inhibitor formation:
Slovenian: Injiciranje raztopine
English: Dose volume in ml = 0.117 x body weight in kilograms.
Slovenian: Velikost odmerka v ml = 0,117 x bolnikova telesna masa v kilogramih.
English: Do not use this medicine if there are particles in it or it is discoloured when reconstituted.
Slovenian: Če so po pripravi zdravila v njem delci ali je obarvano, zdravila ne uporabite.
English: Although expressed in the same unit (IU), the posology of NovoThirteen is different from the dosing schedule of the other FXIII containing products (see section 4.4).
Slovenian: Čeprav se odmerki zdravila NovoThirteen izražajo z enakimi enotami (i.e.), kot so v uporabi pri odmernih shemah drugih zdravil, ki vsebujejo FXIII, je njegovo odmerjanje drugačno (glejte poglavje
English: One vial contains catridecacog (recombinant coagulation factor XIII) (rDNA) 2500 IU per 3 ml, after reconstitution corresponding to a concentration of 833 IU/ml.
Slovenian: Ena viala vsebuje 2500 i.e. katridekakoga (rekombinantni koagulacijski faktor XIII) (rDNA) v 3 ml, kar po pripravi ustreza koncentraciji 833 i.e./ml.
English: Dose volume in millilitres = 0.117 x body weight in kilograms.
Slovenian: Velikost odmerka v mililitrih = 0,117 x bolnikova telesna masa v kilogramih.
English: NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (rDNA factor XIII)
Slovenian: NovoThirteen 2500 i.e. prašek in vehikel za raztopino za injiciranje katridekakog (rDNA faktor XIII)
English: Talk to your doctor before using NovoThirteen:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo NovoThirteen Ne uporabljajte zdravila NovoThirteen:
English: The enzymatic activity resides with the FXIII A-subunit.
Slovenian: Za encimsko delovanje je odgovorna podenota A FXIII.
English: In the event of either being observed, discard the medicinal product.
Slovenian: Če opazite kar koli od tega, zdravilo zavrzite.
English: The preparation should be administered as a slow bolus intravenous injection at a rate not higher than 2 ml/minute.
Slovenian: Zdravilo je treba aplicirati s počasno bolusno intravensko injekcijo; hitrost dajanja ne sme preseči
English: For children weighing less than 24 kg the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to be able to handle the dosing of small children.
Slovenian: Pri otrocih, ki tehtajo manj kot 24 kg, je treba pripravljeno zdravilo NovoThirteen za ustrezno odmerjanje pri majhnih otrocih dodatno razredčiti s 6 ml 0,9 % raztopine natrijevega klorida za injiciranje.
English: • A drop in the number of some types of white blood cells.
Slovenian: • zmanjšanje števila nekaterih vrst belih krvnih celic; to pomeni, da je lahko vaše telo dovzetnejše za okužbe
English: Fertility
Slovenian: NovoThirteen
English: Polysorbate 20
Slovenian: natrijev klorid saharoza polisorbat 20
English: When the FXIII Asubunit is bound to the FXIII B-subunit [A2B2], the half-life of the FXIII A-subunit [A2] is prolonged.
Slovenian: Ko je podenota A FXIII vezana na podenoto B [A2B2],
English: If the patient weighs less than 24 kg, the reconstituted NovoThirteen should be diluted with 6 ml of sodium chloride 0.9%, solution for injection (refer to the section Use in the paediatric population for further detailed instructions on the dilution step).
Slovenian: Če bolnik tehta manj kot 24 kg, je treba pripravljeno zdravilo NovoThirteen razredčiti s 6 ml 0,9 % raztopine natrijevega klorida za injiciranje (za dodatna navodila o razredčevanju glejte poglavje "Uporaba v pediatrični populaciji").
English: Gently swirl the vial to mix the solution.
Slovenian: Previdno vrtite vialo, da boste premešali raztopino.
English: NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection
Slovenian: NovoThirteen 2500 i.e. prašek in vehikel za raztopino za injiciranje
English: Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection
Slovenian: Uporaba v pediatrični populaciji Razredčenje pripravljenega zdravila z 0,9 % raztopino natrijevega klorida za injiciranje
English: A pivotal prospective, open-label, single-arm phase 3 trial (F13CD-1725) including 41 patients with FXIII A-subunit deficiency was conducted to investigate the haemostatic efficacy of rFXIII in patients with congenital FXIII deficiency as reflected by the rate of bleeding episodes requiring treatment with a FXIII-containing product.
Slovenian: Preskušanje je zajelo 41 bolnikov s pomanjkanjem podenote A FXIII, hemostatsko učinkovitost pa so ocenjevali z deležem krvavitev, ki so zahtevale zdravljenje z zdravilom s FXIII.
English: There is limited clinical experience in administering NovoThirteen to elderly patients with congenital FXIII deficiency.
Slovenian: Z uporabo zdravila NovoThirteen pri starejših bolnikih s prirojenim pomanjkanjem FXIII je malo kliničnih izkušenj.
English: Inhibitor formation to NovoThirteen therapy has not been detected in clinical trials.
Slovenian: V kliničnih preskušanjih niso odkrili nastajanja zaviralcev v odziv na zdravljenje z zdravilom NovoThirteen.
English: Allergic reactions
Slovenian: Bolezni živčevja
English: If either is noticed, please discard.
Slovenian: Če opazite delce ali obarvanje, raztopino zavrzite.
English: Screw the syringe tightly onto the vial adapter on the solvent vial.
Slovenian: Brizgo trdno privijte na nastavek za vialo, nameščen na viali z vehiklom.
English: Powder:
Slovenian: Vehikel:
English: NovoThirteen 2500 IU powder for injection catridecacog
Slovenian: NovoThirteen 2500 i.e. prašek za injiciranje katridekakog i.v.
English: Pull the plunger to draw the solvent into the syringe.
Slovenian: Izvlecite bat, da boste vehikel potegnili v brizgo.