FrancophonIA/ELRC3.0 huggingface dataset:
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Slovenian: Količino, ki jo je treba aplicirati, in pogostost aplikacije zdravila je treba vsakokrat prilagoditi glede na klinično učinkovitost v posameznem primeru.
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Slovenian: Ciljne vrednosti faktorja VIII so odvisne od resnosti in mesta krvavitve.
English: Therefore, Vihuma should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Zato smete zdravilo uporabljati med nosečnostjo in dojenjem samo, če je nujno potrebno.
English: Normal weight (n=14)
Slovenian: Normalna telesna teža (n=14)
English: Clean the chosen injection site with one of the provided alcohol swabs.
Slovenian: Izbrano mesto injiciranja očistite z enim izmed priloženih alkoholnih zložencev.
English: Vihuma replaces the missing factor VIII and is used for treatment and prevention of bleeding in patients with haemophilia A and can be used for all age groups.
Slovenian: Zdravilo Vihuma nadomešča manjkajoči faktor VIII in se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A. Zdravilo Vihuma je primerno za uporabo pri vseh starostnih skupinah.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Slovenian: Predvsem pri večjih kirurških posegih je nujno natančno spremljanje poteka nadomestne terapije z analizo strjevanja krvi (aktivnost faktorja VIII v plazmi).
English: Specific studies with long-term repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with Vihuma due to the immune response to heterologous proteins in all non-human mammalian species.
Slovenian: Specifične študije z dolgotrajno ponavljajočimi se odmerki zdravila Vihuma na sposobnost razmnoževanja, kronično toksičnost in karcinogeni potencial niso bile izvedene zaradi imunskega odgovora vseh nehumanih sesalcev na heterologne beljakovine.
English: Treatment of bleeding: The median dose to treat break-through bleeding episodes was 33.0 IU/kg in these patients who were on prophylaxis.
Slovenian: Zdravljenje krvavitev: Mediana odmerka za zdravljenje nepričakovanih krvavitev je bila 33,0 i.e./kg za tiste bolnike, ki so bili zdravljeni preventivno.
English: The solution should be clear and colourless, practically free from visible particles.
Slovenian: Raztopina mora biti bistra in brezbarvna, skoraj brez vidnih delcev.
English: Normal weight: BMI 18.5-25 kg/m2, Pre-adipose: BMI 25-30 kg/m2, Adipose: BMI > 30 kg/m2, SD = Standard deviation
Slovenian: Normalna telesna masa: ITM 18,5-25 kg/m2, Predadipoznost: ITM 25-30 kg/m2, Debelost: ITM > 30 kg/m2, SD = standardni odklon
English: The posology is the same in adults and children, however, shorter dose intervals or higher doses may be necessary for children.
Slovenian: Odmerjanje je pri odraslih in otrocih enako, vendar pa so pri otrocih lahko potrebni krajši intervali med odmerki ali višji odmerki.
English: Once the product has been taken out of the refrigerator the product must not be returned to the refrigerator.
Slovenian: Ko je zdravilo enkrat vzeto iz hladilnika, se ga ne sme več vrniti vanj.
English: If you have the impression that the effect of Vihuma is insufficient, talk to your doctor.
Slovenian: Če imate občutek, da je učinek zdravila Vihuma nezadosten, se posvetujte z zdravnikom.
English: No studies were performed on the mutagenic potential of Vihuma.
Slovenian: Študije potencialne mutagenosti zdravila Vihuma niso bile opravljene.
English: If you have used a tourniquet to make the vein easier to see, this tourniquet should be released before you start injecting the solution.
Slovenian: Če ste uporabili prevezo, da bi laže videli veno, morate prevezo sprostiti, preden začnete injicirati raztopino.
English: Table 1 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Preglednica 1 je v skladu z razvrstitvijo organskih sistemov po MedDRA (raven organskih sistemov in prednostnih izrazov).
English: Insert the needle of the infusion set into the chosen vein.
Slovenian: Vstavite iglo infuzijskega sistema v izbrano veno.
English: Without removing the syringe, gently move or swirl the vial in circles a few times to dissolve the powder.
Slovenian: Ne da bi odstranili brizgo, nekajkrat na rahlo zaokrožite ali obrnite vialo, da raztopite prah.
English: The immunogenicity of Vihuma was evaluated in clinical trials in 190 previously treated patients with severe haemophilia A (129 adult and 61 paediatric patients).
Slovenian: Imunogenost zdravila Vihuma so ocenili v kliničnih preskušanjih pri 190 predhodno zdravljenih bolnikih s hudo hemofilijo A (129 odraslih in 61 pediatričnih bolnikov).
English: The amino acid sequence is comparable to the 90 + 80 kDa form of human plasma factor VIII (i.e. B-domain deleted).
Slovenian: Aminokislinsko zaporedje je primerljivo z obliko 90 + 80 kDa humanega plazemskega faktorja VIII (npr. z izpuščeno domeno B).
English: In patients with haemophilia A (inborn factor VIII deficiency), factor VIII is missing or not working properly.
Slovenian: Pri bolnikih s hemofilijo A (prirojeno pomanjkanje faktorja VIII) faktor VIII ni prisoten ali ne deluje pravilno.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
Slovenian: Aktivnost faktorja VIII v plazmi izražamo bodisi v odstotkih (glede na normalno humano plazmo) ali pa po možnosti v mednarodnih enotah (glede na mednarodni standard za faktor VIII v plazmi).
English: Use the reconstituted solution immediately after reconstitution.
Slovenian: Raztopino uporabite takoj po rekonstituciji.
English: Octapharma AB Lars Forssells gata 23 112 75 Stockholm SWEDEN
Slovenian: Octapharma AB Lars Forssells gata 23 112 75 Stockholm Švedska
English: The number of units of factor VIII administered is expressed in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products.
Slovenian: Število apliciranih enot faktorja VIII je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na veljavni standard SZO za koncentrate faktorja VIII.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2% of normal activity or 2 IU/dl.
Slovenian: Izračun potrebnega odmerka faktorja VIII sloni na empirični ugotovitvi, da 1 mednarodna enota (i.e.) faktorja VIII na kilogram telesne mase poveča plazemsko aktivnost faktorja VIII za 2 % normalne aktivnosti ali 2 i.e./dl.
English: Vihuma is usually injected into a vein (intravenously) by your doctor or a nurse who are experienced in the care of patients with haemophilia A. You or someone else might also give your Vihuma injection, but only after receiving adequate training.
Slovenian: Zdravilo Vihuma v veno (intravensko) običajno vbrizga zdravnik ali medicinska sestra, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo A. Morda bi lahko vi ali kdo drug prav tako dal injekcijo zdravila Vihuma, vendar šele po ustreznem usposabljanju.
English: The median consumption of Vihuma for prophylaxis per month was 521.9 IU/kg.
Slovenian: Mediana porabe zdravila Vihuma za preventivo na mesec je bila 521,9 i.e./kg.
English: After reconstitution, the solution is clear, colourless and free from foreign particles.
Slovenian: Po rekonstituciji je raztopina bistra, brezbarvna in ne vsebuje vidnih tujih delcev.
English: Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur.
Slovenian: Prav tako lahko pride do znatnih razlik med rezultati preskusa, pridobljenih z enostopenjskim preskusom strjevanja na osnovi aPTČ, in kromogenim preskusom po Evropski farmakopeji (Ph.
English: During clinical studies with Vihuma in previously treated paediatric (2 to 11 years, n = 58), adolescent (12 to 17 years, n = 3) and adult patients (n = 129) with severe haemophilia A, a total of 12 adverse drug reactions (ADRs) (8 in adults, 4 in children) were reported in 8 patients (4 adults, 4 children).
Slovenian: Med kliničnimi študijami z zdravilom Vihuma pri predhodno zdravljenih otrocih (od 2 do 11 let, n = 58), mladostnikih (od 12 do 17 let, n = 3) in odraslih bolnikih (n = 129) s hudo hemofilijo A so pri 8 bolnikih (4 odraslih, 4 otrocih) poročali o skupno 12 neželenih učinkih zdravila (8 pri odraslih, 4 pri otrocih).
English: The solvent is water for injections in a pre-filled glass syringe.
Slovenian: Vehikel je voda za injekcije v napolnjeni stekleni injekcijski brizgi.
English: This should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih, ki so na dieti z malo natrija.
English: However depending on the body weight and posology, the patient could receive more than one vial.
Slovenian: Vendar pa lahko glede na telesno maso in odmerjanje bolnik prejme več kot eno vialo.
English: The usual dose of Vihuma is 20 to 40 IU per kg body weight, given every 2 to 3 days.
Slovenian: Običajen odmerek zdravila Vihuma je 20 do 40 i.e. na kg telesne mase, daje pa se ga vsaka 2 do 3 dni.
English: Side effects related to central venous access devices (CVAD): Catheter-related infection, general (systemic) infection and local blood clot at the catheter site.
Slovenian: Neželeni učinki, povezani z napravami za centralni venski dostop (CVAD): Okužbe, povezane s katetrom, splošna (sistemska) okužba in lokalni krvni strdek na mestu katetra.
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Slovenian: Med zdravljenjem je priporočljivo določanje vrednosti faktorja VIII kot vodilo pri odmerjanju in določanju pogostnosti ponavljanja infuzij.
English: The powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied injection set.
Slovenian: Prašek je treba pripraviti le s priloženim vehiklom (2,5 ml vode za injekcije), z uporabo priloženega pribora za injiciranje.
English: Other medicines and Vihuma Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katerokoli drugo zdravilo.
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dl) x 0.5 (IU/kg per IU/dl)
Slovenian: Potrebno število enot = telesna masa (kg) x želeno zvišanje faktorja VIII (%) (i.e./dl) x 0,5 (i.e./kg na i.e./dl)
English: INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION
Slovenian: Navodila za pripravo in aplikacijo
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, zlasti pri mlajših bolnikih, bodo morda potrebni krajši presledki med odmerki ali pa večji odmerki.
English: Marketing Authorisation Holder and Manufacturer Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Švedska
English: A higher median dose of Vihuma was required to treat bleedings in children (43.9 IU/kg) than in adults (33.0 IU/kg), and a higher median dose was required to treat moderate to major than minor bleedings (78.2 IU/kg vs. 41.7 IU/kg).
Slovenian: Višja mediana odmerka zdravila Vihuma je bila potrebna za zdravljenje krvavitev pri otrocih (43,9 i.e./kg) kot pri odraslih (33,0 i.e./kg) in višja mediana odmerka je bila potrebna za zdravljenje zmernih do večjih kot pa manjših krvavitev
English: Clinical efficacy and in-vivo recovery of Vihuma was not affected in this patient.
Slovenian: Klinična učinkovitost ter in vivo uporabnost zdravila Vihuma pri tem bolniku nista bili prizadeti.
English: Factor VIII level required (%) (IU/dL)
Slovenian: Potrebna koncentracija faktorja VIII (%) (i.e./dl)
English: It is strongly recommended that every time that Vihuma is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Slovenian: Močno priporočamo, da vsakič, ko bolnik prejme zdravilo Vihuma, zabeležite ime in številko serije zdravila, da ohranite povezavo med bolnikom in serijo zdravila.
English: Keep the reconstituted solution at room temperature.
Slovenian: Rekonstituirano raztopino hranite pri sobni temperaturi.
English: It is strongly recommended that every time that Vihuma is administered, the name and batch number of the product are recorded in order to maintain a link between you and the batch of the medicinal product.
Slovenian: Močno priporočamo, da vsakič, ko prejmete zdravilo Vihuma, zabeležite ime in številko serije zdravila, da ohranite povezavo med vami in serijo zdravila.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike je treba informirati o zgodnjih opozorilnih znakih preobčutljivosti, ki vključujejo izpuščaj, generalizirano urtikarijo, tiščanje v prsih, sopenje, hipotenzijo in anafilakso.
English: If your plasma factor VIII fails to reach expected levels with Vihuma, or if bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors.
Slovenian: Če vaš plazemski faktor VIII s pomočjo zdravila Vihuma ne dosega pričakovane ravni ali če krvavitev ni ustrezno obvladana, je to lahko posledica nastanka zaviralcev faktorja VIII.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja zdravila Vihuma z drugimi zdravili niso izvedli.
English: Uncommon side effects may affect up to 1 in 100 people Tingling or numbness (paraesthesia), headache, injection site inflammation, injection site pain, back pain, vertigo, dry mouth, dizziness, a vague feeling of bodily discomfort, shortness of breath.
Slovenian: Občasni neželeni učinki se lahko pojavijo pri največ 1 od 100 bolnikov Mravljinčenje ali omrtvelost (parestezija), glavobol, vnetje na mestu injiciranja, bolečina na mestu injiciranja, bolečina v hrbtu, vrtoglavica, suha usta, omotica, neopredeljiv občutek telesnega neugodja,
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje zdravila in ravnanje z zdravilom
English: Excipient(s) with known effect 7.35 mg sodium per ml reconstituted solution (18.4 mg sodium per vial).
Slovenian: 7,35 mg natrija na ml rekonstituirane raztopine (18,4 mg natrija na vialo).
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a Factor VIII activity of 30% to 60% (IU/dL).
Slovenian: Infuzijo ponavljajte na vsakih 8-24 h, dokler se rana zadostno ne zaceli, nato nadaljujte s terapijo še najmanj naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII med 30 in 60 % (i.e./dl).
English: In the case of the following haemorrhagic events, factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Slovenian: V primeru spodaj navedenih krvavitev aktivnost faktorja VIII v ustreznem časovnem obdobju ne sme pasti pod navedeno stopnjo plazemske aktivnosti (v % od normale ali i.e./dl).
English: AUC (hr*IU/ml)
Slovenian: AUC (h*i.e./ml)
English: Pre-adipose (n=4)
Slovenian: Predadipoza (n=4)
English: Treatment with Vihuma will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor or nurse has told you.
Slovenian: Zdravljenje z zdravilom Vihuma bo začel zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo A. Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali medicinske sestre.
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Slovenian: Jakost zdravila (i.e.) je določena s pomočjo kromogenega testa po evropski farmakopeji.
English: The vial should be gently rotated until all powder is dissolved.
Slovenian: Vialo rahlo zavrtite, dokler se ne raztopi ves prašek.
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours when stored at room temperature.
Slovenian: Po rekonstituciji Po rekonstituciji je zdravilo pri sobni temperaturi kemijsko in fizikalno stabilno 24 h.
English: Frequency of adverse drug reactions (ADRs) in clinical trials MedDRA Standard System
Slovenian: Pogostnost pojava neželenih učinkov zdravila (NUZ) v kliničnih preskušanjih
English: Driving and using machines Vihuma has no influence on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Vihuma ne vpliva na vašo sposobnost upravljanja vozil in strojev.
English: How to use Vihuma
Slovenian: Kako uporabljati zdravilo Vihuma
English: IVR (%/IU/kg)
Slovenian: IVR (%/i.e./kg)
English: CL (ml/hr/kg)
Slovenian: CL (ml/h/kg)
English: Sodium chloride Calcium chloride dihydrate Arginine hydrochloride Sodium citrate dihydrate Poloxamer 188
Slovenian: Prašek saharoza natrijev klorid kalcijev klorid dihidrat argininijev klorid natrijev citrat dihidrat poloksamer 188
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Each powder vial contains 250, 500, 1000, 2000, 2500, 3000 or 4000 IU of simoctocog alfa.
Slovenian: Ena viala s praškom vsebuje 250, 500, 1000, 2000, 2500, 3000 ali 4000 i.e. simoktokoga alfa.
English: If you stop using Vihuma Do not stop using Vihuma without consulting your doctor or pharmacist.
Slovenian: Ne prenehajte uporabljati zdravila Vihuma, ne da bi se posvetovali z zdravnikom ali farmacevtom.
English: Prophylaxis: In a clinical study in 32 adult patients with severe haemophilia A, the median consumption of Vihuma for prophylaxis was 468.7 IU/kg/month.
Slovenian: V klinični študiji 32 odraslih bolnikov s hudo hemofilijo A je bila mediana porabe zdravila Vihuma za preventivo 468,7 i.e./kg/mesec.
English: Younger children in general required higher median doses (6-12 years: 43.9 IU/kg; 2-5 years: 52.6 IU/kg).
Slovenian: (6-12 let: 43,9 i.e./kg; 2-5 let: 52,6 i.e./kg).
English: Degree of haemorrhage/ Type of surgical procedure
Slovenian: Stopnja krvavitve/ vrsta kirurškega posega
English: The following table can be used to guide dosing in bleeding episodes and surgery.
Slovenian: Spodnjo preglednico lahko uporabljate kot vodilo za odmerjanje pri krvavitvah in kirurških posegih.
English: Uncommon*
Slovenian: občasni*
English: Please record the beginning of storage at room temperature on the product carton.
Slovenian: Na škatlo zdravila zapišite začetek shranjevanja pri sobni temperaturi.
English: Only the provided injection sets should be used because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some injection equipment.
Slovenian: Za rekonstitucijo in dajanje zdravila se sme uporabljati samo priloženi pribor, saj je lahko zdravljenje zaradi adsorpcije humanega faktorja strjevanja krvi VIII na notranje stene nekaterih pripomočkov za injiciranje neuspešno.
English: Simoctocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 1440 amino acids.
Slovenian: Simoktokog alfa (humani koagulacijski faktor VIII (rDNK)) je očiščena beljakovina s 1440
English: Early haemarthrosis, muscle bleeding or oral bleeding
Slovenian: Zgodnja hemartroza, krvavitev v mišico ali krvavitev v ustni votlini
English: The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Rekonstituirano zdravilo je treba pred aplikacijo s prostim očesom pregledati glede vsebnosti trdnih delcev in obarvanosti.
English: # Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Slovenian: # Pogostnost temelji na študijah z vsemi zdravili s FVIII, ki so vključevale bolnike s hudo hemofilijo A.
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Slovenian: Pri določanju aktivnosti faktorja VIII v krvi bolnikov z in vitro enostopenjskim testom strjevanja na osnovi aktiviranega parcialnega tromboplastinskega časa (aPTČ) lahko na aktivnost faktorja VIII v plazmi pomembno vplivata tako vrsta reagenta za aPTČ kot tudi referenčni standard, ki se uporablja v testu.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Slovenian: Če je potreben centralni venski dostop (CVAD - central venous access device), tveganja zapletov, povezanih s CVAD, obsegajo lokalne okužbe, bakteriemijo in trombozo na mestu katetra.
English: Vihuma contains traces of human host cell proteins other than factor VIII.
Slovenian: Zdravilo Vihuma vsebuje poleg faktorja VIII sledi beljakovin humanih gostiteljskih celic.
English: The powder is a white to offwhite friable powder in a glass vial.
Slovenian: Prašek je bel ali belkast drobljiv prašek v stekleni viali.
English: Warnings and precautions Talk to your doctor or pharmacist before using Vihuma.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Vihuma se posvetujte z zdravnikom.
English: If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.
Slovenian: Če potrebujete centralni venski dostop (CVAD - central venous access device), je treba računati na tveganja zapletov, povezanih s CVAD, ki obsegajo lokalne okužbe, prisotnost bakterij v krvi in trombozo na mestu katetra.
English: In preclinical studies, Vihuma was used to safely and effectively restore haemostasis in dogs with haemophilia.
Slovenian: 5.3 Predklinični podatki o varnosti V predkliničnih raziskavah je bilo zdravilo Vihuma uporabljeno za varno in učinkovito obnavljanje hemostaze pri psih s hemofilijo.
English: No cases of overdose have been reported.
Slovenian: Ni poročil o prevelikem odmerjanju.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial.
Slovenian: Zdravilo Vihuma vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo.
English: - The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188.
Slovenian: - Druge sestavine zdravila so saharoza, natrijev klorid, kalcijev klorid dihidrat, argininijev klorid, natrijev citrat dihidrat, poloksamer 188.
English: Can be stored at room temperature (up to 25°C) for a single period up to 1 month.
Slovenian: Zdravilo je lahko shranjeno pri sobni temperaturi (do 25 °C) za enkratno obdobje, ki ni daljše od 1 meseca.
English: Expected factor VIII rise (% of normal) = 2 x administered IU body weight (kg)
Slovenian: Pričakovano zvišanje faktorja VIII (% od normale) = 2 x dani odmerek i.e.
English: (pre- and postoperative)
Slovenian: (pred kirurškim posegom in po njem)