FrancophonIA/ELRC3.0 huggingface dataset:
English: The speed of injection should be based on your comfort, but should not be faster than 2 mL per minute.
Slovenian: Hitrost injiciranja naj bo prilagojena vašemu počutju, vendar ne injicirajte hitreje kot 2 ml na minuto.
English: a heart disease or are at risk of heart disease.
Slovenian: • imate bolezen srca ali pri vas obstaja tveganje za bolezen srca.
English: The powder is dry and white to slightly yellow .
Slovenian: Prašek je suh in bel do rahlo rumen.
English: A total of 204 subjects have been included in the clinical trial program, 153 subjects ≥ 12 years and 51 subjects < 12 years.
Slovenian: V program kliničnega preskušanja je bilo skupno vključenih 204 oseb, 153 oseb ≥ 12 let in 51 oseb
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
English: In completed clinical studies with 71 paediatric previously treated patients, the frequency, type and severity of adverse reactions in children were found to be similar to those in adults.
Slovenian: V zaključenih kliničnih študijah s 71 pediatričnimi predhodno zdravljenimi bolniki so ugotovili, da so bili pogostnost, vrsta in resnost neželenih učinkov pri otrocih podobni kot pri odraslih.
English: Therefore, factor VIII should be used during pregnancy only if clearly indicated.
Slovenian: Faktor VIII se sme med nosečnostjo uporabljati le, če je to jasno indicirano.
English: Component of a multipack, can't be sold separately.
Slovenian: Posamezna pakiranja se ne smejo prodajati ločeno.
English: Do not use this medicine after the expiry date which is stated on labels and cartons.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepkah in škatli.
English: Set the syringe aside for further use.
Slovenian: Injekcijsko brizgo dajte na stran za nadaljnjo uporabo.
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Slovenian: Pri bolnikih z visokimi ravnmi inhibitorjev morda zdravljenje s faktorjem VIII ne bo učinkovito in bo treba razmisliti o drugih možnostih zdravljenja.
English: If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
Slovenian: Če inhibitorji nastanejo, se to kaže kot nezadosten klinični odziv.
English: Since Kovaltry is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.
Slovenian: Ker je zdravilo Kovaltry nadomestna beljakovina endogenega faktorja VIII, neželeni učinki na plodnost niso pričakovani.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Slovenian: Če pričakovane aktivnosti faktorja VIII v plazmi niso dosežene ali če krvavitve z ustreznim odmerkom ni mogoče obvladati, je treba opraviti preiskave glede prisotnosti inhibitorjev faktorja VIII.
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: 8 do 24 ur, dokler se rana ustrezno ne zaceli; nato nadaljujte zdravljenje vsaj še naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII na 30 do 60 % (i.e./dl).
English: These may be signs of a rare severe sudden allergic reaction to Kovaltry.
Slovenian: To so lahko znaki redke, hude nenadne alergijske reakcije na zdravilo Kovaltry.
English: If this happens your medicine may stop working properly and you may experience persistent bleeding.
Slovenian: Če se to zgodi, morda zdravilo ne bo več učinkovito in bo krvavitev vztrajala.
English: The specific activity of Kovaltry is approximately 4000 IU/mg protein.
Slovenian: Specifična aktivnost zdravila Kovaltry je približno 4000 i.e./mg beljakovine.
English: The number of factor VIII units is expressed in International Units (IU).
Slovenian: Odmerek enot faktorja VIII je izražen v mednarodnih enotah (i.e.).
English: These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors.
Slovenian: Zaradi inhibitorjev, zlasti če je njihova raven visoka, je zdravilo manj učinkovito, zato bodo vas ali vašega otroka skrbno spremljali glede nastanka inhibitorjev.
English: Kovaltry is prepared by recombinant technology without addition of any human- or animal derived components in the manufacturing process.
Slovenian: Zdravilo Kovaltry je pridobljeno z rekombinantno tehnologijo brez dodane kakršne koli sestavine humanega ali živalskega izvora v postopku izdelave.
English: Follow the instructions for use given by your doctor and provided at the end of this leaflet.
Slovenian: Natančno upoštevajte navodila zdravnika in navodila za uporabo, ki jih najdete na koncu tega navodila.
English: No animal fertility studies have been conducted with Kovaltry and its effect on human fertility has not been established in controlled clinical trials.
Slovenian: Plodnost Študij na živalih o vplivu zdravila Kovaltry na plodnost niso izvedli in njegovih učinkov na plodnost pri ljudeh niso ugotavljali v nadzorovanih kliničnih preskušanjih.
English: Treatment with Kovaltry will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as described in this leaflet and as your doctor or pharmacist has told you.
Slovenian: Zdravljenje z zdravilom Kovaltry lahko začne zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo A. Zdravilo vedno uporabljajte tako kot je opisano v navodilu za uporabo oziroma tako kot vam je svetoval zdravnik ali farmacevt..
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests (see section 4.2).
Slovenian: Vse bolnike, ki se zdravijo z zdravili s koagulacijskim faktorjem VIII, je treba z ustreznim kliničnim opazovanjem in laboratorijskimi preiskavami skrbno spremljati glede nastanka inhibitorjev (glejte poglavje 4.2).
English: Be sure that the powder is completely dissolved.
Slovenian: Preverite če se je ves prašek raztopil.
English: It is recommended that every time you use Kovaltry, you note down the name and batch number of the product.
Slovenian: Priporočljivo je, da ob vsaki uporabi zdravila Kovaltry zabeležite ime zdravila in številko serije.
English: N=115
Slovenian: Preiskovanci n = 115
English: Two multi-centre, open-label, cross-over, uncontrolled, randomised studies in previously treated adults/adolescents with severe haemophilia A (< 1%) and one multi-centre, open-label, uncontrolled study in previously treated children < 12 years with severe haemophilia A were conducted.
Slovenian: Izvedli so dve multicentrični, odprti, navzkrižni, nenadzorovani, randomizirani študiji pri predhodno zdravljenih odraslih/mladostnikih s težko stopnjo hemofilije A (< 1 %) in eno multicentrično, odprto, nenadzorovano študijo pri predhodno zdravljenih otrocih < 12 let s težko stopnjo hemofilije A.
English: The solvent is a clear liquid.
Slovenian: Vehikel je bistra tekočina.
English: If you have been told by your doctor that you have developed factor VIII inhibitors you may need to use a larger dose of Kovaltry to control bleeding.
Slovenian: Če vam je zdravnik povedal, da so pri vas nastali inhibitorji faktorja VIII, boste morda za nadzor krvavitev potrebovali večji odmerek zdravila Kovaltry.
English: Kovaltry can be used in children of all ages.
Slovenian: Zdravilo Kovaltry se lahko uporablja pri otrocih vseh starosti.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Slovenian: Ni poročil medsebojnem delovanju zdravil s humanim koagulacijskim faktorjem VIII (rDNK) z drugimi zdravili.
English: You will need alcohol swabs, gauze pads, plasters and tourniquet.
Slovenian: Potrebovali boste alkoholne zložence, gaze, obliže in prevezo.
English: Apply a tourniquet to your arm.
Slovenian: Namestite prevezo na roko.
English: Kovaltry can be used for all age groups.
Slovenian: Zdravilo Kovaltry se lahko uporablja za vse starostne skupine.
English: This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, injected two or three times per week.
Slovenian: Običajni odmerek je od 20 do 40 i.e. oktokoga alfa na kilogram telesne mase, injiciran dva- ali trikrat na teden.
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Slovenian: 12 do 24 ur, 3 do 4 dni ali več, dokler ne mineta bolečina in akutna onesposobljenost.
English: Kovaltry is prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation.
Slovenian: Zdravilo Kovaltry je pripravljeno brez dodajanja kakršnih koli beljakovin humanega ali živalskega izvora v postopku gojenja celičnih kultur, v procesu prečiščevanja ali v končno zdravilo.
English: It is unknown whether Kovaltry is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Kovaltry izloča v materino mleko.
English: A population PK model was developed based on all available factor VIII measurements (from dense PK sampling and all recovery samples) throughout the 3 clinical studies allowing calculation of PK parameters for subjects in the various studies.
Slovenian: Populacijski farmakokinetični model je bil razvit na podlagi vseh razpoložljivih meritev aktivnosti faktorja VIII (iz vzorcev, pridobljenih s pogostim farmakokinetičnim vzorčenjem, in vseh vzorcev za določitev dviga aktivnosti) v vseh 3 kliničnih študijah, kar je omogočilo izračun farmakokinetičnih parametrov za preiskovance v različnih študijah.
English: Chromogenic assay results Median; (Q1; Q3) (IU/dL / IU/kg) One-stage assay results Median; (Q1; Q3) (IU/dL / IU/kg)
Slovenian: Izsledki kromogene metode Mediana; (Q1; Q3) (i.e./dl / i.e./kg) Izsledki enostopenjske metode Mediana; (Q1; Q3) (i.e./dl / i.e./kg)
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy is not available.
Slovenian: Ker je hemofilija A pri ženskah redka, izkušenj z uporabo faktorja VIII med nosečnostjo ni na voljo.
English: The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Slovenian: Nastanek inhibitorjev (protiteles) je znan zaplet, ki se lahko pojavi med zdravljenjem z vsemi zdravili s faktorjem VIII.
English: Hold an unopened vial and also a syringe in your hands to warm it to a comfortable temperature (do not exceed 37 °C).
Slovenian: Z rokami ogrejte neodprto vialo in injekcijsko brizgo do primerne temperature (ne na več kot 37 °C).
English: For major surgery in particular, your blood clotting must be closely monitored.
Slovenian: Predvsem pri velikih kirurških posegih je treba skrbno spremljati strjevanje krvi.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Slovenian: V takih primerih se priporoča, da se obrnete na specialistični center za zdravljenje hemofilije.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se zdravila ne uporabi takoj po rekonstituciji, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
English: The Pharmacokinetic (PK) profile of Kovaltry was evaluated in PTPs with severe haemophilia A following 50 IU/kg in 21 subjects ≥ 18 years, 5 subjects ≥ 12 years and < 18 years and 19 subjects < 12 years of age.
Slovenian: Farmakokinetični (FK) profil zdravila Kovaltry so ocenili pri predhodno zdravljenih bolnikih s težko stopnjo hemofilije A po prejemu 50 i.e./kg pri 21 osebah ≥ 18 let, 5 osebah ≥ 12 let in < 18 let in 19 osebah < 12 let.
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses for adolescents (≥ 12 years age) and adult patients are 20 to 40 IU of Kovaltry per kg body weight two to three times per week.
Slovenian: Za dolgotrajno preprečevanje krvavitev pri bolnikih s težko stopnjo hemofilije A so običajni odmerki za mladostnike (≥ 12 let) in odrasle bolnike od 20 do 40 i.e. zdravila Kovaltry na kg telesne mase dvado trikrat na teden.
English: Kovaltry does not contain von Willebrand factor.
Slovenian: Zdravilo Kovaltry ne vsebuje von Willebrandovega faktorja.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Slovenian: Posamezni bolniki se lahko različno odzivajo na faktor VIII, kar se kaže v različnem razpolovnem času in dvigu aktivnosti.
English: Do not increase the dose of Kovaltry to control your bleeding without checking with your doctor.
Slovenian: Ne povečajte odmerka zdravila Kovaltry za nadzor krvavitev, ne da bi se posvetovali z zdravnikom.
English: Q1 first quartile; Q3 third quartile
Slovenian: LSK - letna stopnja krvavitve Q1 prvi kvartil; Q3 tretji kvartil
English: Patients with inhibitors
Slovenian: Bolniki z inhibitorji
English: The analysis of all recorded incremental recoveries in previously treated patients demonstrated a median rise of > 2% (> 2 IU/dL) per IU/kg body weight for Kovaltry.
Slovenian: Analiza vseh zabeleženih dejanskih dvigov aktivnosti (t.i. incremental recovery) pri predhodno zdravljenih bolnikih je pokazala mediano dviga za > 2 % (> 2 i.e./dl) na i.e./kg telesne mase za zdravilo Kovaltry.
English: If any component of the package is opened or damaged, do not use this component.
Slovenian: Če je kateri koli sestavni del pakiranja odprt ali poškodovan, ga ne uporabite.
English: Children and adolescents The listed warnings and precautions apply to patients of all ages, adults and children.
Slovenian: Navedena opozorila in previdnostni ukrepi veljajo za bolnike vseh starosti, za odrasle in otroke.
English: If your or your child's bleeding is not being controlled with Kovaltry, tell your doctor immediately.
Slovenian: Če krvavitev pri vas ali vašem otroku z zdravilom Kovaltry ni mogoče obvladati, morate takoj obvestiti zdravnika.
English: What you need to know before you use Kovaltry
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Kovaltry
English: Repeat infusion every 8 to 24 hours until threat is resolved
Slovenian: 8 do 24 ur, dokler ogroženost ne mine.
English: Kovaltry is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Slovenian: Ni verjetno, da bi zdravilo Kovaltry vplivalo na plodnost bolnikov ali bolnic, saj je učinkovina v telesu naravno prisotna.
English: In this case, the product expires at the end of this 12 month period or the expiry date on the product vial, whichever is earlier.
Slovenian: V tem primeru se rok uporabnosti zdravila izteče ob koncu 12-mesečnega obdobja ali z datumom izteka roka uporabnosti navedenega na viali zdravila, odvisno kaj nastopi prej.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Required units = body weight (kg) x desired factor VIII rise (% or IU/dL) x reciprocal of observed recovery (i.e. 0.5 for recovery of 2.0%).
Slovenian: Potrebno število enot = telesna masa (kg) x želeni dvig faktorja VIII (% ali i.e./dl) x recipročna vrednost dejanskega dviga aktivnosti (npr. 0,5 za 2,0 % dvig aktivnosti).
English: These items are not included in the Kovaltry package.
Slovenian: Ti pripomočki niso priloženi v pakiranju zdravila Kovaltry.
English: Each vial of Kovaltry contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Slovenian: Ena viala zdravila Kovaltry vsebuje nominalno 250, 500, 1000, 2000 ali 3000 i.e. oktokoga alfa.
English: What Kovaltry is and what it is used for What you need to know before you use Kovaltry How to use Kovaltry
Slovenian: Kaj je zdravilo Kovaltry in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Kovaltry
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 velikih kirurških posegih je nujno natančno spremljanje nadomestnega zdravljenja s testi strjevanja krvi (aktivnosti faktorja VIII v plazmi).
English: Therefore, factor VIII should be used during breast-feeding only if clearly indicated.
Slovenian: Faktor VIII se sme med dojenjem uporabljati le, če je to jasno indicirano.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Slovenian: Nastanek protiteles, ki nevtralizirajo faktor VIII (inhibitorji), je znan zaplet pri zdravljenju posameznikov s hemofilijo A. Ti inhibitorji so ponavadi imunoglobulini IgG, ki zavirajo prokoagulantno delovanje faktorja VIII, njihovo količino pa določamo v Bethesda enotah (B.e.) na ml plazme z uporabo modificiranega testa.
English: EXP (End of the 12 month period, if stored up to 25 °C): ................ Do not use after this date.
Slovenian: EXP (konec 12 mesečnega obdobja, če zdravilo shranjujete pri temperaturi do 25 °C): ............ Ne uporabljajte po tem datumu.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerjanje zdravila in trajanje nadomestnega zdravljenja sta odvisna od stopnje pomanjkanja aktivnosti faktorja VIII, mesta in obsega krvavitve in od kliničnega stanja bolnika.
English: 1 multipack with 30 single packs.
Slovenian: − 1 skupno pakiranje s 30 posameznimi pakiranji.
English: Fill the syringe by drawing the plunger out slowly and smoothly.
Slovenian: Napolnite injekcijsko brizgo tako, da počasi in enakomerno izvlečete bat brizge.
English: Attach the syringe to the venipuncture set (J).Ensure that no blood enters the syringe.
Slovenian: Injekcijsko brizgo privijte na pribor za vensko punkcijo (J) in preverite, da v injekcijsko brizgo ni prišla kri.
English: If patients experience dizziness or other symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the reaction subsides.
Slovenian: Če bolnik občuti omotico ali katere koli druge simptome, ki vplivajo na sposobnost koncentracije in njegove reakcije, je priporočljivo, da ne vozi ali upravlja strojev, dokler ti učinki ne minejo.
English: EXP (End of the 12 month period, if stored up to 25 °C): ................
Slovenian: EXP (konec 12 mesečnega obdobja, če zdravilo shranjujete pri temperaturi do 25 °C): ............
English: Duration of treatment Usually, Kovaltry treatment for haemophilia is needed life-long.
Slovenian: Običajno je zdravljenje hemofilije z zdravilom Kovaltry potrebno celo življenje.
English: Holding the vial adapter in place, remove the syringe from the vial adapter (the adapter should remain attached to the vial).
Slovenian: Adapter za vialo držite na mestu in odstranite injekcijsko brizgo z adapterja za vialo (adapter naj ostane pritrjen na vialo).
English: Other medicines and Kovaltry 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 katero koli drugo zdravilo.
English: allergic to mouse or hamster proteins.
Slovenian: • alergični na beljakovine miši ali hrčkov.
English: • Known allergic reactions to mouse or hamster proteins.
Slovenian: • znane alergijske reakcije na beljakovine miši ali hrčkov
English: If this happens, please contact your doctor immediately.
Slovenian: V tem primeru se takoj posvetujte z zdravnikom.
English: If you forget to use Kovaltry
Slovenian: Če ste pozabili uporabiti zdravilo Kovaltry
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor VIII in plasma).
Slovenian: Aktivnost faktorja VIII v plazmi je izražena v odstotkih (glede na aktivnost v normalni humani plazmi) ali v mednarodnih enotah (i.e.) (glede na mednarodni standard za faktor VIII v plazmi).
English: Each single package of Kovaltry contains:
Slovenian: Vsako posamezno pakiranje zdravila Kovaltry vsebuje
English: Kovaltry is used to treat and prevent bleeding in adults, adolescents and children of all ages with haemophilia A (hereditary factor VIII deficiency).
Slovenian: Zdravilo Kovaltry se uporablja za zdravljenje in preprečevanje krvavitev pri odraslih, mladostnikih in otrocih vseh starosti s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: Kovaltry should be injected intravenously over 2 to 5 minutes depending on the total volume.
Slovenian: Zdravilo Kovaltry je treba injicirati intravensko 2 do 5 minut, odvisno od skupnega volumna zdravila.
English: • one pre-filled syringe with 2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and
Slovenian: • 1 napolnjeno injekcijsko brizgo z 2,5 ml (za 250 i.e., 500 i.e. in 1000 i.e.) ali 5 ml (za 2000 i.e.
English: Multipack with 30 single packs, each containing:
Slovenian: Skupno pakiranje s 30 posameznimi pakiranji, vsako posamezno pakiranje vsebuje:
English: The listed warnings and precautions apply both to adults and children.
Slovenian: Pediatrična populacija Navedena opozorila in previdnostni ukrepi veljajo za odrasle in otroke.
English: The amount to be administered and the frequency of administration should always be targeted to the clinical effectiveness required in the individual case.
Slovenian: Število danih enot in pogostnost odmerjanja je treba vedno določiti glede na klinično učinkovitost,
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, and is therefore considered essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: No symptoms of overdose with recombinant human coagulation factor VIII have been reported.
Slovenian: Ni poročil o simptomih zaradi prevelikega odmerjanja rekombinantnega humanega koagulacijskega faktorja VIII.
English: Dose/prophylaxis injection, IU/kg BW median (min, max)
Slovenian: profilaktična injekcija i.e./kg telesne mase mediana (min, max)
English: Only the provided infusion sets should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Slovenian: Za rekonstitucijo in injiciranje zdravila se sme uporabiti samo priloženi pribor za infundiranje, ker je lahko zdravljenje zaradi adsorpcije humanega rekombinantnega koagulacijskega faktorja VIII na notranje površine nekaterih drugih pripomočkov za injiciranje, neuspešno.
English: Elevation of factor VIII levels following administration, in particular in those with existing cardiovascular risk factors, might cause a patient to have the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
Slovenian: Povečanje aktivnosti faktorja VIII po aplikaciji, zlasti pri tistih s prisotnimi dejavniki tveganja za srčnožilne bolezni, lahko predstavlja pri bolniku najmanj enako tveganje za zaporo žil ali miokardni infarkt kakor pri populaciji, ki nima hemofilije.
English: Detailed instructions for reconstitution and administration of Kovaltry
Slovenian: Podrobnejša navodila za rekonstitucijo in dajanje zdravila Kovaltry