FrancophonIA/ELRC3.0 huggingface dataset:
English: See section 2, “Vihuma contains sodium”.
Slovenian: Glejte poglavje 2, "Zdravilo Vihuma vsebuje natrij".
English: If you have injected more Vihuma than you should, please inform your doctor.
Slovenian: Če ste si vbrizgali več zdravila Vihuma, kot bi smeli, o tem obvestite svojega zdravnika.
English: One International Unit (IU) of factor VIII activity is equivalent to the quantity of factor VIII in one ml of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem mililitru normalne humane plazme.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se rekonstituiranega zdravila ne uporabi takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik.
English: Allow the solvent syringe (water for injections) and the powder in the closed vial to reach room temperature.
Slovenian: Pustite, da se vehikel v brizgi (voda za injekcije) in prašek v zaprti viali segrejeta na sobno temperaturo.
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Slovenian: Z mikrobiološkega stališča je treba rekonstituirano zdravilo porabiti takoj.
English: Toxicology studies showed that local intravenous administration and systemic exposure were well tolerated in laboratory animals (rats and cynomolgus monkeys).
Slovenian: Toksikološke študije so pokazale, da so laboratorijske živali (podgane in opice cynomolgus) dobro prenašale lokalno intravensko dajanje in sistemsko izpostavljenost.
English: A prospective open-label clinical study in PUPs with severe haemophilia A (<1% FVIII:C) is ongoing.
Slovenian: Prospektivna odprta klinična študija pri predhodno nezdravljenih bolnikih s hudo hemofilijo A (<1% FVIII:C) je v teku.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vihuma in one or more subsets of the paediatric population in treatment of haemophilia A (congenital Factor VIII deficiency) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obveznost predložitve rezultatov študij z zdravilom Vihuma za eno ali več podskupin pediatrične populacije pri zdravljenju hemofilije A (prirojeno pomanjkanje faktorja VIII) (za podatke o uporabi pri pediatrični glejte poglavje 4.2).
English: The dose of Vihuma is calculated depending on your body weight and the factor VIII levels to be achieved.
Slovenian: Odmerek zdravila Vihuma se izračuna glede na vašo telesno maso in raven faktorja VIII, ki jo je treba doseči.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Odmerke na osnovi telesne mase bo pri bolnikih s prenizko ali prekomerno telesno maso morda treba prilagoditi.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Slovenian: Posamezni bolniki se lahko na faktor VIII odzivajo različno, kar se kaže v različnem razpolovnem času zdravila in času okrevanja.
English: After reconstitution, the solution should be drawn back into the syringe.
Slovenian: Po pripravi je treba raztopino povleči nazaj v brizgo.
English: Wipe the top of the vial with an alcohol swab.
Slovenian: Vrh viale obrišite z alkoholnim zložencem.
English: If you or your child´s bleeding is not being controlled with Vihuma, tell your doctor immediately.
Slovenian: Če krvavitev pri vas ali vašem otroku z zdravilom Vihuma ni obvladana, morate to nemudoma povedati zdravniku.