FrancophonIA/ELRC3.0 huggingface dataset:
English: ReFacto AF should be administered using the infusion set included in the kit, unless otherwise advised by your doctor or other healthcare professional.
Slovenian: Zdravilo ReFacto AF je treba dati z infuzijskim sistemom, ki se nahaja v kompletu, razen če vaš zdravnik ali drug zdravstveni delavec ni priporočil drugače.
English: Population pharmacokinetic modeling using data from 44 PUPs led to a mean estimated half-life of 8.0 ± 2.2 hours.
Slovenian: Povprečni ocenjeni razpolovni čas, ocenjen s populacijskim farmakokinetičnim modelom ob uporabi podatkov 44 PUP, je bil 8,0 ± 2,2 ure.
English: The number of units of factor VIII administered is expressed in International Units (IUs), which are related to the current WHO standard for factor VIII products.
Slovenian: Število enot danega faktorja VIII je izraženo v mednarodnih enotah (i.e.), ki so povezane s standardom SZO za zdravila, ki vsebujejo faktor VIII.
English: The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for recovery, AUCt and AUC∞ (area under the plasma concentration curve from time zero to infinity), respectively.
Slovenian: Kvocienti geometrijskih sredin najmanjših kvadratov zdravila ReFacto AF proti zdravilu ReFacto so bili 100,6 % za zvečanje aktivnosti, 99,5 % za AUCt in 98,1 %, za AUC (površina pod krivuljo plazemske koncentracije od časa nič do neskončnosti).
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 pro-coagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Slovenian: Nastanek protiteles, ki nevtralizirajo faktor VIII (zaviralci), je znan zaplet pri zdravljenju posameznikov s hemofilijo A. Ti zaviralci so običajno imunoglobulini IgG, ki zavirajo prokoagulantno aktivnost faktorja VIII, njihovo količino pa določamo v enotah Bethesda (B.e.) na ml plazme z uporabo prilagojenega testa.
English: The ratios of geometric least-square means of month 6-to-baseline pharmacokinetic were 107%, 100% and 104% for recovery, AUCt and AUC∞, respectively.
Slovenian: Kvocienti geometrijskih sredin najmanjših kvadratov farmakokinetike po 6 mesecih proti izhodišču so bili 107 % za zvečanje aktivnosti, 100 % za AUCt in 104 %, za AUC.
English: If a patient normally treated with XYNTHA is prescribed ReFacto AF, the treating physician may consider adjustment of dosing recommendations based on factor VIII recovery values.
Slovenian: Če lečeči zdravnik predpiše bolniku, ki se navadno zdravi z zdravilom XYNTHA, zdravilo ReFacto AF, mora upoštevati popravek priporočil za odmerjanje na podlagi vrednosti zvečanja aktivnosti faktorja VIII.
English: At least 1 day until the bleeding episode as indicated by pain is resolved or healing is achieved.
Slovenian: Najmanj 1 dan, dokler se krvavitev ne ustavi (orientiramo se po bolečini), oziroma se rana ne zaceli.
English: In patients with haemophilia A (inborn factor VIII deficiency), it is missing or not working properly.
Slovenian: Pri bolnikih s hemofilijo A (prirojeno pomanjkanje faktorja VIII) ga ni ali ne deluje pravilno.
English: Angina pectoris; tachycardia; palpitations
Slovenian: Srčne bolezni angina pektoris; tahikardija; palpitacije
English: The corresponding 90% confidence intervals about the ratios of month 6-to-baseline for the above pharmacokinetic parameters were within the equivalence window of 80% to 125%.
Slovenian: Ustrezni 90 % intervali zaupanja okrog kvocientov geometrijskih sredin najmanjših kvadratov farmakokinetike po 6 mesecih proti izhodišču za zgoraj navedene farmakokinetične parametre so bili znotraj ekvivalenčnega okna med 80 % in 125 %.
English: Severe, sudden allergic (anaphylactic) reactions are uncommon (may affect up to 1 in 100 people).
Slovenian: Hude, nenadne alergijske (anafilaktične) reakcije so občasne (pojavijo se lahko pri največ 1 od 100 bolnikov).
English: Remove the empty ReFacto AF pre-filled syringe and repeat procedures 3 and 4 above for any additional reconstituted syringes.
Slovenian: Odstranite prazno napolnjeno injekcijsko brizgo zdravila ReFacto AF in ponovite v točkah 3 in 4 opisane postopke pri vseh naslednjih brizgah, ki vsebujejo pripravljeno raztopino.
English: The medicinal product contains traces of hamster proteins.
Slovenian: Zdravilo vsebuje sledi beljakovin hrčka.
English: Pfizer Limited Tel: +44 (0)1304 616161
Slovenian: United Kingdom Pfizer Limited Tel: +44 (0)1304 616161
English: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Slovenian: Zdravljenje in profilaksa krvavitev pri bolnikih s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: Whilst continuing to hold the ReFacto AF pre-filled syringe upright, remove the grey rubber tip cap and replace it with the protective blue vented cap.
Slovenian: Medtem, ko še vedno držite injekcijsko brizgo zdravila ReFacto AF v pokončnem položaju, odstranite vrhnjo sivo gumijasto zaporko in jo zamenjajte z zaščitno modro zaporko z odprtinami.
English: Data on immune tolerance induction (ITI) have been collected in patients with haemophilia A who had developed inhibitors to factor VIII.
Slovenian: Podatke o indukciji imunske tolerance (ITI - Immune Tolerance Induction) so zbirali pri bolnikih s hemofilijo A, pri katerih so se razvili zaviralci faktorja VIII.
English: In a ReFacto AF study of 19 PUPs, the recovery at the beginning of the study in the 17 children aged 28 days to less than 2 years was 1.32 ± 0.65 IU/dl per IU/kg and in the 2 children aged 2 to <6 years were 1.7 and 1.8 IU/dl per IU/kg.
Slovenian: V študiji zdravila ReFacto AF pri 19 PUP je bilo zvečanje aktivnosti na začetku študije pri 17 otrocih, starih od 28 dni do manj kot 2 leti, 1,32 ± 0,65 i.e./dl na i.e./kg, pri 2 otrocih, starih 2 do < 6 let, pa 1,7 oziroma 1,8 i.e./dl na i.e./kg.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Slovenian: Odziv posameznih bolnikov na faktor VIII je lahko različen, kar se kaže v različnih razpolovnih časih in različnem zvečanju aktivnosti.
English: Throughout the reconstitution process, it is important to keep the ReFacto AF pre-filled syringe upright (with the white powder above the clear solution) to prevent possible leakage.
Slovenian: Med postopkom priprave zdravila za uporabo je pomembno, da držite napolnjeno injekcijsko brizgo zdravila ReFacto AF v pokončnem položaju (pri čemer se bel prašek nahaja nad bistro raztopino), da bi preprečili morebitno iztekanje.
English: It is a glycoprotein with an approximate molecular mass of 170,000 Da consisting of 1438 amino acids.
Slovenian: To je glikoprotein s približno molekulsko maso 170.000 Da.
English: Use immediately or within 3 hours of reconstitution.
Slovenian: Uporabite takoj oziroma najkasneje v 3 urah po rekonstituciji.
English: This indicates no time-dependent changes in the pharmacokinetic properties of ReFacto AF.
Slovenian: To kaže, da se farmakokinetične lastnosti zdravila ReFacto AF ne spreminjajo v odvisnosti od časa.
English: Note: If you need to use more than one pre-filled syringe of ReFacto AF per infusion, each syringe should be reconstituted according to the specific directions.
Slovenian: Opomba: Če morate uporabiti več kot eno vialo zdravila ReFacto AF na infuzijo, morate vsako vialo pripraviti po navedenih navodilih.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Slovenian: Velikost odmerka in pogostnost odmerjanja je treba prilagoditi individualno glede na klinično učinkovitost.
English: • muscular pain
Slovenian: • bolečina v mišicah
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 seznaniti z zgodnjimi znaki preobčutljivostnih reakcij, vključno s koprivnico, generalizirano urtikarijo, stiskanjem v prsnem košu, piskajočim dihanjem, hipotenzijo in anafilaksijo.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently for ReFacto, and may in some cases progress to severe anaphylaxis including shock (see section 4.4).
Slovenian: V redkih primerih so pri zdravilu ReFacto opazili preobčutljivostne ali alergijske reakcije (kot so angioedem, pekoč občutek in zbadanje na mestu infuzije, mrzlica, rdečica, generalizirana urtikarija, glavobol, koprivnica, hipotenzija, letargija, navzea, nemirnost, tahikardija, stiskanje v prsnem košu, mravljinčenje, bruhanje in piskajoče dihanje), ki so v posameznih primerih napredovale v hudo anafilaksijo, vključno s šokom (glejte poglavje 4.4).
English: Pharmacokinetic properties of ReFacto, derived from a cross-over study of ReFacto and a plasmaderived FVIII concentrate, using the chromogenic substrate assay (see section 4.2), in 18 previously treated patients are listed in the table below.
Slovenian: Farmakokinetične lastnosti zdravila ReFacto, pridobljene iz navzkrižne študije zdravila ReFacto in koncentrata FVIII, pridobljenega iz plazme, z uporabo preskusa s kromogenim substratom (glejte poglavje 4.2) pri 18 predhodno zdravljenih bolnikih, so navedene v spodnji preglednici.
English: * The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay.
Slovenian: *Aktivnost (mednarodne enote) je določena po Evropski farmakopeji s pomočjo preskusa z uporabo kromogenega substrata.
English: ReFacto AF has no influence on the ability to drive and use machines.
Slovenian: Zdravilo ReFacto AF nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Pfizer PFE, spol.
Slovenian: Česká Republika Pfizer PFE, spol.
English: In a cross-over pharmacokinetic study, the pharmacokinetic parameters for ReFacto AF were determined at baseline and followed up in 25 previously treated patients (≥ 12 years) after repeated administration of ReFacto AF for six months.
Slovenian: V navzkrižni farmakokinetični študiji so določili farmakokinetične parametre zdravila ReFacto AF ob izhodišču in pri 25 predhodno zdravljenih bolnikih (≥ 12 let) po ponovnem dajanju zdravila ReFacto AF v obdobju 6 mesecev.
English: In the PUPs, the mean recovery was stable over time (5 visits during a 2-year period) and ranged from 1.5 to 1.8 IU/dl per IU/kg.
Slovenian: Pri PUP je bilo povprečno zvečanje aktivnosti stabilno (5 obiskov v obdobju dveh let) in je znašalo od 1,5 do 1,8 i.e./dl na i.e./kg.
English: In the same study, in which the drug potency of ReFacto AF and a full-length recombinant factor VIII (FLrFVIII) comparator, and the FVIII activity measured in patient plasma samples were all determined using the same one-stage clotting assay at a central laboratory, ReFacto AF was shown to be pharmacokinetically equivalent to FLrFVIII in 30 previously treated patients (≥ 12 years) using the standard bioequivalence approach.
Slovenian: V isti študiji, v kateri so merili jakost zdravila ReFacto AF in primerjalnega rekombinantnega faktorja VIII celotne dolžine (FLrFVIII) in aktivnost FVIII v vzorcih plazme, vseh merjenih z enakim enostopenjskim koagulacijskim preskusom v centralnem laboratoriju, so s standardnim bioekvivalenčnim pristopom pokazali, da je zdravilo ReFacto AF farmakokinetično ekvivalentno FLrFVIII pri 30 predhodno zdravljenih bolnikih (≥ 12 let).
English: Pfizer Tél: +33 (0)1 58 07 34 40
Slovenian: Tél: +33 (0)1 58 07 34 40
English: If you stop using ReFacto AF
Slovenian: Če ste prenehali uporabljati zdravilo ReFacto AF
English: Administration (Intravenous Infusion)
Slovenian: Dajanje zdravila (intravensko infundiranje)
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: V primeru velikega kirurškega posega je treba še posebej skrbno spremljati nadomestno zdravljenje s koagulacijskimi preskusi (aktivnost faktorja VIII).
English: BRANCH) Τηλ: +357 22 817690
Slovenian: (CYPRUS BRANCH) Τηλ: +357 22 817690
English: Abbreviations: Cmax = maximum observed plasma concentration; CV = coefficient of variation; AUCinf = area under the plasma concentration-time profile from time zero extrapolated to infinite time; t½ = terminal half-life; CL = clearance; Vss = steady-state volume of distribution.
Slovenian: Okrajšave: Cmax = največja opažena plazemska koncentracija; CV = koeficient variance; AUCinf = površina pod krivuljo plazemska koncentracija-čas od časa nič ekstrapolirano do neskončnosti; t½ = končni razpolovni čas; CL = očistek; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja.
English: FVIII inhibition (PTPs)*
Slovenian: zaviranje FVIII (PTP)
English: The dose and frequency of ReFacto AF prescribed throughout the study were at the investigator's discretion as per local standard of care.
Slovenian: Odmerek in pogostnost dajanja predpisanega zdravila ReFacto AF v času trajanja študije je določil raziskovalec po lastni presoji v skladu z lokalnim standardom oskrbe.
English: Also there can be significant discrepancies between assay results obtained by aPTT-based one-stage clotting assay and the chromogenic assay.
Slovenian: Prav tako lahko pride do večjih neskladij med rezultati enostopenjskega koagulacijskega preskusa na podlagi aPTČ in rezultati kromogenega preskusa.
English: After infusing ReFacto AF, remove the infusion set and discard.
Slovenian: Po infundiranju zdravila ReFacto AF infuzijski sistem odstranite in ga zavrzite.
English: Remove the protective needle cover and insert the butterfly needle of the infusion set tubing into your vein, as instructed by your doctor or other healthcare professional.
Slovenian: Odstranite varovalni pokrovček igle in si iglo z metuljčkom na infuzijskem sistemu vstavite v veno, po navodilih, ki ste jih dobili od svojega zdravnika ali drugega zdravstvenega delavca.
English: The table lists adverse reactions reported in the clinical trials with ReFacto or ReFacto AF.
Slovenian: V preglednici so navedeni neželeni učinki, o katerih so poročali v kliničnih preskušanjih z zdravilom ReFacto ali ReFacto AF.
English: The product, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl) phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Slovenian: Pripravljena raztopina zdravila vsebuje polisorbat-80, ki dokazano poveča izluženje di-(2-etilheksil)ftalata (DEHP) iz PVC-ja.
English: • chills, catheter site reaction
Slovenian: • mrzlica, reakcija na mestu katetra
English: Patients should follow the specific reconstitution and administration procedures provided by their doctors.
Slovenian: Bolniki morajo vedno upoštevati specifična navodila glede priprave raztopine in načina uporabe, ki so jih dobili od svojega zdravnika.
English: Trace amounts of hamster protein may be present in ReFacto AF.
Slovenian: V zdravilu ReFacto AF so lahko prisotne sledi beljakovin hrčka.
English: Allergic type hypersensitivity reactions have been observed with ReFacto AF.
Slovenian: Pri zdravilu ReFacto AF so opazili preobčutljivostne reakcije alergijskega tipa.
English: Remove the protective blue vented cap and firmly attach the intravenous infusion set provided onto the ReFacto AF pre-filled syringe.
Slovenian: Odstranite zaščitno modro zaporko z odprtinami in trdno pritrdite priloženi sistem za intravensko infundiranje na napolnjeno injekcijsko brizgo zdravila ReFacto AF.
English: More extensive haemarthrosis, muscle bleeding or haematoma
Slovenian: Obsežnejše krvavitve v sklep, mišice ali hematomi
English: Gently and slowly advance the plunger rod by pushing until the two plungers inside the pre-filled syringe meet, and all of the solvent is transferred to the top chamber containing the ReFacto AF powder.
Slovenian: Nežno in počasi potisnite bat naprej, dokler ne pride do stika obeh gumijastih tesnil znotraj napolnjene injekcijske brizge in ves vehikel ne preide v zgornji razdelek, ki vsebuje prašek zdravila ReFacto AF.
English: Do not use ReFacto AF
Slovenian: Ne uporabljajte zdravila ReFacto AF
English: The corresponding 90% confidence intervals about the ratios of ReFacto AF to ReFacto geometric means were within the bioequivalence window of 80% to 125%, demonstrating bioequivalence of ReFacto AF to ReFacto.
Slovenian: Ustrezni 90 % intervali zaupanja okrog kvocientov geometrijskih sredin najmanjših kvadratov zdravila ReFacto AF proti zdravilu ReFacto so bili znotraj bioekvivalenčnega okna med 80 % in 125 %, kar je pokazalo bioekvivalenco zdravila ReFacto AF proti zdravilu ReFacto.
English: The need for an increased dose relative to that used for adults and older children should be anticipated when treating younger children (less than 6 years of age) with ReFacto AF (see section 5.2)..
Slovenian: Pri zdravljenju mlajših otrok (mlajši od 6 let) z zdravilom ReFacto AF moramo pričakovati potrebo po zvečanem odmerku v primerjavi s tistim, ki se uporablja pri odraslih in starejših otrocih (glejte poglavje 5.2).
English: When monitoring patients' factor VIII activity levels during treatment with ReFacto AF, use of the chromogenic assay is recommended.
Slovenian: Pri spremljanju vrednosti aktivnosti faktorja VIII pri bolnikih med zdravljenjem z zdravilom ReFacto AF je priporočljiva uporaba kromogenega preskusa.
English: 1 gauze
Slovenian: 1 bat
English: Uncommon ≥ 1/1,000 to
Slovenian: Občasni ≥ 1/1.000 do < 1/100
English: Grasp the plunger rod as shown in the following diagram.
Slovenian: Primite bat, kot je prikazano na sliki spodaj.
English: Place the vial on a flat surface.
Slovenian: Postavite vialo na ravno površino.
English: The reported lack of effect with ReFacto has been described as bleeding into target joints, bleeding into new joints or a subjective feeling by the patient of new onset bleeding.
Slovenian: opisujejo kot krvavitve v tarčne sklepe, krvavitve v nove sklepe ali bolnikov subjektivni občutek, da se začenja nova krvavitev.
English: Dose by weight (IU/kg) per bleeding episode for bleed treatment median (min, max)
Slovenian: Odmerek glede na telesno maso (i.e./kg) na epizodo krvavitve pri zdravljenju krvavitve mediana vrednost (največja, najmanjša)
English: Screw the plunger rod firmly into the opening in the finger rest of the ReFacto AF pre-filled syringe by pushing and turning clockwise firmly until resistance is felt (approximately 2 turns).
Slovenian: Bat trdno privijte v odprtino pri opori za prste na napolnjeni injekcijski brizgi zdravila ReFacto AF, tako da potiskate in čvrsto obračate bat v smeri urnega kazalca, dokler ne začutite upora (približno 2 zasuka).
English: Vss, mL/kgb a Geometric mean (geometric CV%) for all, except for arithmetic mean ±SD for incremental recovery and t½.
Slovenian: Geometrijska sredina (geometrijski CV%) pri vseh, z izjemo aritmetične sredine ± SD pri prirastnem zvečanju aktivnosti in t½.
English: In PUPs, pharmacokinetic parameters of ReFacto were evaluated using the chromogenic assay.
Slovenian: Pri PUP so ovrednotili farmakokinetične parametre zdravila ReFacto s kromogenim preskusom.
English: Additional safety experience in children has been accrued through studies that encompassed both previously treated (n=18 aged <6 years and n=19 aged 6 to <12 years) and previously untreated (n=23 aged <6 years) patients and which supports a safety profile similar with that observed in adult patients.
Slovenian: S študijami, ki so zajemale predhodno zdravljene bolnike (n = 18, stare < 6 let, in n = 19, stare 6 do < 12 let) in predhodno nezdravljene bolnike (n = 23, stare < 6 let), so pridobili dodatne izkušnje o varnosti pri otrocih, ki podpirajo varnostni profil, podoben varnostnemu profilu, ki so ga opazili pri odraslih bolnikih.
English: When infused into a haemophiliac patient, factor VIII binds to the von Willebrand factor present in the patient's circulation.
Slovenian: Faktor VIII se po infundiranju bolniku s hemofilijo veže na von Willebrandov faktor, prisoten v bolnikovi krvi.
English: Intravenous use, after reconstitution.
Slovenian: za intravensko uporabo, po rekonstituciji
English: Holding the pre-filled syringe upright, remove the white tamper-evident seal by bending the seal right to left (or a gentle rocking motion) to break the perforation of the cap and expose the grey rubber tip cap of the ReFacto AF pre-filled syringe.
Slovenian: Držite napolnjeno injekcijsko brizgo v pokončnem položaju in odstranite belo zaščitno zaporko, tako da jo upogibate z desne na levo (ali jo nežno zanihate) in prelomite perforacijo; tako boste razkrili sivo gumijasto zaporko napolnjene injekcijske brizge zdravila ReFacto AF.
English: Contains 4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection
Slovenian: Vsebuje 4 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Degree of haemorrhage/ Type of surgical procedure
Slovenian: Stopnja krvavitve/ tip operacije
English: 1 plaster
Slovenian: 1 obliž
English: It is recommended that every time you use ReFacto AF, you record the name on the carton and batch number of the product.
Slovenian: Priporočljivo je, da si vsakič, ko uporabite zdravilo ReFacto AF, zabeležite ime zdravila, navedeno na škatli, in številko serije zdravila.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
Slovenian: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
English: Other sterile disposable syringes may be used for administration.
Slovenian: Za uporabo zdravila lahko uporabite tudi druge sterilne brizge za enkratno uporabo.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia A.
Slovenian: Zdravljenje naj začne zdravnik z izkušnjami pri zdravljenju hemofilije A.
English: Reconstitution:
Slovenian: Priprava:
English: Česká Republika
Slovenian: Slovenská republika
English: How to use ReFacto AF
Slovenian: Kako uporabljati zdravilo ReFacto AF
English: 1 plunger rod 1 sterile infusion set 2 alcohol swabs 1 plaster
Slovenian: 1 sterilen infuzijski sistem 2 alkoholna zloženca 1 obliž
English: ReFacto AF is provided as a powder for injection in a glass vial and a solvent is provided in a prefilled syringe.
Slovenian: Zdravilo ReFacto AF je na voljo v obliki praška za injiciranje v stekleni viali, priložen je vehikel v napolnjeni injekcijski brizgi.
English: Doses administered should be titrated to the patient's clinical response.
Slovenian: Uporabljene odmerke je treba prilagoditi glede na bolnikov odziv.
English: • difficulty in breathing, wheezing, tightness in the chest
Slovenian: • oteženo dihanje, piskajoče dihanje, stiskanje v prsnem košu
English: 1 sterile infusion set 2 alcohol swabs
Slovenian: 1 sterilen infuzijski sistem 2 alkoholna zloženca
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 so priporočljivi ustrezni testi za določanje aktivnosti faktorja VIII, da ugotovimo potrebne odmerke in pogostnost infuzij.
English: Appropriate training is recommended for non-healthcare professionals administering the product.
Slovenian: Za osebe, ki dajejo zdravilo in niso zdravstveni delavci, je priporočljivo, da se ustrezno izurijo.
English: • inhibitor development for patients who have been previously treated with factor VIII products (less than 1 in 100 patients)
Slovenian: • nastanek zaviralcev pri bolnikih, ki so se že prej zdravili z zdravili s faktorjem VIII (manj kot 1