FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study in which the potency of ReFacto AF, ReFacto and FVIII activity in patient plasma were measured using the chromogenic substrate assay, ReFacto AF was shown to be bioequivalent to ReFacto.
Slovenian: V študiji, v kateri so merili aktivnost zdravil ReFacto AF in ReFacto ter aktivnost faktorja VIII v bolnikovi plazmi s preskusom s kromogenim substratom, se je zdravilo ReFacto AF izkazalo kot bioekvivalentno zdravilu ReFacto.
English: After reconstitution this medicinal product contains 1.23 mmol (29 mg) sodium per vial or pre-filled syringe, to be taken into consideration by patients on a controlled sodium diet.
Slovenian: Po rekonstituciji to zdravilo vsebuje 1,23 mmol (29 mg) natrija na vialo ali napolnjeno injekcijsko brizgo, kar morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
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: Kadar se za določanje aktivnosti faktorja VIII v vzorcu bolnikove krvi uporablja enostopenjski koagulacijski preskus na podlagi in vitro tromboplastinskega časa (aPTČ), lahko na rezultate aktivnosti faktorja VIII v plazmi pomembno vplivata vrsta reagenta za aPTČ in referenčni standard, uporabljen v preskusu.
English: Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit.
Slovenian: Namestite manšeto in pripravite mesto injiciranja tako, da kožo dobro očistite z alkoholnim zložencem, ki je priložen v kompletu.
English: The vial should be gently rotated until all of the powder is dissolved.
Slovenian: Vialo previdno sučite, dokler se ves prašek ne raztopi.
English: Powder and solvent for solution for injection in pre-filled syringe FuseNGo
Slovenian: prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi FuseNGo
English: • decreased appetite, diarrhoea, vomiting, stomach pain, nausea
Slovenian: • pomanjkanje apetita, driska, bruhanje, bolečine v želodcu, občutek siljenja na bruhanje
English: Please dispose of all unused solution, the empty vial(s) and the used needles and syringes in an appropriate container for throwing away of medical waste as these materials may hurt others if not disposed of properly.
Slovenian: Po uporabi zavrzite vso neuporabljeno raztopino, prazno/-e vialo/-e in uporabljeno/-e iglo/-e ter brizgo/-e v ustrezno posodo za medicinske odpadke, saj lahko ti predmeti poškodujejo druge, če jih ne boste zavrgli na pravilen način.
English: Connect a sterile 10 cc or larger luer lock syringe to one opening (port) in the syringe connector and the ReFacto AF pre-filled syringe to the remaining open port on the opposite end.
Slovenian: 3 ali večjo brizgo z nastavkom Luer lock na eno odprtino (vhod) na spojniku za brizge, napolnjeno injekcijsko brizgo zdravila ReFacto AF pa na drugi prosti vhod na nasprotni strani.
English: Insert the needle on the infusion set tubing into the vein as instructed by your doctor, and remove the tourniquet.
Slovenian: Zabodite iglo na infuzijskem sistemu v veno v skladu z navodili svojega zdravnika in snemite manšeto.
English: 1 vented sterile cap
Slovenian: 1 sterilna zaporka z odprtinami
English: What ReFacto AF looks like and contents of the pack
Slovenian: Izgled zdravila ReFacto AF in vsebina pakiranja
English: • chest pain, rapid heart beat, palpitations
Slovenian: • bolečina v prsnem košu, pospešen srčni utrip, razbijanje srca (palpitacije)
English: Remove the luer-to-luer syringe connector from the 10 cc or larger luer lock syringe and attach the infusion set, as described above in the directions for administration of the pre-filled syringe [see Administration (Intravenous Infusion)].
Slovenian: 3 ali večje brizge z nastavkom Luer lock in pripojite infuzijski sistem, kot je opisano zgoraj pri navodilih za dajanje napolnjene injekcijske brizge (glejte naslov »Dajanje zdravila (Intravensko infundiranje)«).
English: The pre-filled syringe consists of 2 chambers, one chamber contains the ReFacto AF lyophilised powder and the other chamber contains the solvent [sodium chloride 9 mg/ml (0.9%) solution].
Slovenian: Napolnjena injekcijska brizga je sestavljena iz 2 razdelkov, en razdelek vsebuje zdravilo ReFacto AF v obliki liofiliziranega praška, drugi razdelek pa vsebuje vehikel [9 mg/ml (0,9 %) raztopina natrijevega klorida].
English: Allow the pre-filled syringe to reach room temperature.
Slovenian: Pustite, da se napolnjena injekcijska brizga ogreje na sobno temperaturo.
English: Mean ± SD FVIII Pharmacokinetic Parameters after Single 50 IU/kg Dose in Paediatric PTPs
Slovenian: Farmakokinetični parametri faktorja VIII (povprečje  SD) po enkratnem odmerku 50 i.e./kg pri pediatričnih PTP farmakokinetični parameter število preskušancev povprečje a  SD
English: Patients can affix one of the peel-off labels found on the vial or pre-filled syringe to document the batch number in their diary or for reporting any side effects.
Slovenian: Bolniki lahko odlepijo eno od nalepk, ki so nalepljene na viali ali napolnjeni injekcijski brizgi, in z njo zabeležijo številko serije v svojem dnevniku ali jo uporabijo pri poročanju o morebitnih neželenih učinkih.
English: 1 vial with 250 IU moroctocog alfa 1 vial with 500 IU moroctocog alfa 1 vial with 1000 IU moroctocog alfa 1 vial with 2000 IU moroctocog alfa
Slovenian: 1 viala z 250 i.e. moroktokoga alfa 1 viala s 500 i.e. moroktokoga alfa 1 viala s 1.000 i.e. moroktokoga alfa 1 viala z 2.000 i.e. moroktokoga alfa
English: For children not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Slovenian: Pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), pa je tveganje občasno (manj kot 1 od 100 bolnikov).
English: One event of cyst in an 11-year old patient and one event described as confusion in a 13-year old patient have been reported as possibly related to ReFacto AF treatment
Slovenian: Kot morebiti povezan z zdravljenjem z zdravilom ReFacto AF je opisan en primer ciste pri 11-letnem bolniku in en primer zmedenosti pri 13-letnem bolniku.
English: Each vial of ReFacto AF contains nominally 250, 500, 1000, or 2000 IU of moroctocog alfa.
Slovenian: Ena viala zdravila ReFacto AF vsebuje nominalno 250, 500, 1000 ali 2000 i.e. moroktokoga alfa.
English: Solvent for ReFacto AF
Slovenian: Vehikel za ReFacto AF
English: i.e., 250, 500, 1000, or 2000 IU), of moroctocog alfa per 1 ml of the prepared solution for injection.
Slovenian: 250, 500, 1000 oziroma 2000 i.e.) moroktokoga alfa na ml pripravljene raztopine za injiciranje.
English: Dose by weight (IU/kg) per prophylaxis infusion a median (min, max)
Slovenian: Odmerek glede na telesno maso (i.e./kg) na profilaktično infuzijo mediana vrednost (največja, najmanjša)
English: Based on their current regimen, individuals with haemophilia A should be advised to bring an adequate supply of factor VIII product for anticipated treatment when travelling.
Slovenian: Bolnikom s hemofilijo A je treba svetovati, naj med potovanjem s seboj vzamejo za režim svojega trenutnega zdravljenja zadostno zalogo zdravila s faktorjem VIII za predvideno zdravljenje.
English: Note: If the solution is not to be used immediately, the syringe cap is to be carefully replaced.
Slovenian: Opomba: Če raztopine ne boste uporabili takoj, pazljivo znova namestite pokrovček brizge.
English: Each pre-filled syringe of ReFacto AF contains nominally 250, 500, 1000, 2000, or 3000 IU of moroctocog alfa.
Slovenian: Ena napolnjena injekcijska brizga zdravila ReFacto AF vsebuje nominalno 250, 500, 1000, 2000 ali 3000 i.e. moroktokoga alfa.
English: 1 pre-filled syringe with 4 ml solvent 1 vial adapter
Slovenian: 1 napolnjena injekcijska brizga s 4 ml vehikla 1 nastavek za vialo
English: Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the post-marketing setting for ReFacto.
Slovenian: V kliničnih preskušanjih in v obdobju trženja zdravila ReFacto so poročali o neučinkovitosti, predvsem pri profilaktično zdravljenih bolnikih.
English: CL, mL/h/kgb
Slovenian: CL, ml/h/kg Vss, ml/kg a
English: ReFacto AF should be infused within 3 hours after either reconstitution or removal of the grey tip cap from the pre-filled syringe.
Slovenian: Zdravilo ReFacto AF je treba infundirati v 3 urah po pripravi oziroma po odstranitvi sive zaporke z napolnjene injekcijske brizge.
English: Neuropathy peripheral; somnolence; dysgeusia
Slovenian: Bolezni živčevja glavobol omotica periferna nevropatija; somnolenca; dizgevzija
English: Remove the plastic flip-top cap from the ReFacto AF vial to expose the central portion of the rubber stopper.
Slovenian: Z viale zdravila ReFacto AF odstranite snemljivo plastično zaporko, da razkrijete osrednji del gumijastega zamaška.
English: Factor VIII activity is greatly reduced in patients with haemophilia A, and, therefore, replacement therapy is necessary.
Slovenian: Pri bolnikih s hemofilijo A je aktivnost faktorja VIII močno zmanjšana, zato je pri njih potrebno nadomestno zdravljenje.
English: Do not touch the inside of the cap or the syringe tip.
Slovenian: Pazite, da se ne dotaknete notranjosti pokrovčka ali konice brizge.
English: After reconstitution, the solution will be clear or slightly opalescent and colourless.
Slovenian: Po rekonstituciji mora biti raztopina bistra ali rahlo opalescentna in brezbarvna.
English: Pfizer Oy Puh/Tel: +358 (0)9 43 00 40
Slovenian: Puh/Tel: +358 (0)9 43 00 40
English: ReFacto AF should not be mixed with other infusion solutions.
Slovenian: Zdravila ReFacto AF ne smete mešati z drugimi raztopinami za infundiranje.
English: - The active substance is moroctocog alfa (recombinant coagulation factor VIII).
Slovenian: - Zdravilna učinkovina je moroktokog alfa (rekombinantni koagulacijski faktor VIII).
English: - The other ingredients are sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80 and sodium chloride.
Slovenian: - Druge sestavine zdravila so saharoza, kalcijev klorid dihidrat, L-histidin, polisorbat 80 in natrijev klorid.
English: - After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], each vial contains 62.5, 125, 250, or 500 IU, respectively (based on the strength of moroctocog alfa,
Slovenian: - Po pripravi s priloženim vehiklom [9 mg/ml (0,9 %) raztopina natrijevega klorida] ena viala vsebuje 62,5, 125, 250 oziroma 500 i.e. (odvisno od jakosti moroktokoga alfa, t.j.
English: ReFacto AF contains the active substance moroctocog alfa, human coagulation factor VIII.
Slovenian: Zdravilo ReFacto AF vsebuje zdravilno učinkovino moroktokog alfa, ki je humani koagulacijski faktor VIII.
English: With the syringe still connected to the adapter, gently rotate the vial until the powder is dissolved.
Slovenian: Medtem, ko je injekcijska brizga še vedno spojena z nastavkom, vialo nežno sučite, dokler se prašek ne raztopi.
English: Continuing to hold the ReFacto AF pre-filled syringe in an upright position, slowly advance the plunger rod until most, but not all, of the air is removed from the (top) chamber.
Slovenian: Še naprej držite napolnjeno injekcijsko brizgo zdravila ReFacto AF v pokončnem položaju in bat počasi potiskajte noter, dokler se iz zgornjega razdelka ne odstrani večina zraka, vendar ne ves zrak.
English: t1/2 (h)
Slovenian: AUCt (i.e.·h/ml) t1/2 (h)
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema zaviranje FVIII (PUP)
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Smernice za pomoč pri odmerjanju ob krvavitvah in ob operacijah so predstavljene v naslednji preglednici:
English: Slowly depress the plunger rod to inject all the solvent into the ReFacto AF vial.
Slovenian: Počasi potisnite bat navzdol in vbrizgajte ves vehikel v vialo zdravila ReFacto AF.
English: The pre-filled syringe should be gently rotated until all of the powder is dissolved.
Slovenian: Napolnjeno injekcijsko brizgo previdno sučite, dokler se ves prašek ne raztopi.
English: ReFacto AF can be stored at room temperature (up to 25oC) for a single period up to 3 months.
Slovenian: Zdravilo ReFacto AF lahko hranite pri sobni temperaturi (do 25 C) eno samo obdobje največ 3 mesecev.
English: Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.
Slovenian: Med pripravo zdravila je treba strogo upoštevati aseptično tehniko (čisto in brez bakterij).
English: - After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], the prepared solution for injection contains either 62.5, 125, 250, 500 or 750 IU of moroctocog alfa per ml, respectively (based on the strength of moroctocog alfa, i.e., 250, 500, 1000, 2000, or 3000 IU).
Slovenian: - Po pripravi s priloženim vehiklom [9 mg/ml (0,9 %) raztopina natrijevega klorida] pripravljena raztopina za injiciranje vsebuje 62,5, 125, 250, 500 oziroma 750 i.e. moroktokoga alfa na ml (odvisno od jakosti moroktokoga alfa, t.j.
English: • bleeding
Slovenian: • krvavitev
English: Slowly draw back all the solution through the vial adapter into the syringe.
Slovenian: Počasi povlecite vso raztopino skozi nastavek viale v brizgo.
English: Remove the tourniquet.
Slovenian: Snemite manšeto.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija mialgija
English: No symptoms of overdose have been reported with recombinant coagulation factor VIII products.
Slovenian: Pri uporabi zdravil z rekombinantnim koagulacijskim faktorjem VIII niso poročali o simptomih prevelikega odmerjanja.
English: Do not use this medicine after the expiry date which is stated on the outer carton and pre-filled syringe label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na napolnjeni injekcijski brizgi poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: MRT (h) recovery (IU/dl increase in FVIII:C per IU/kg FVIII given) Abbreviations: AUCt = area under the plasma concentration-time curve from zero to the last measurable concentration; t½ = half-life; CL = clearance; FVIII:C = FVIII activity; MRT = mean residence time
Slovenian: Okrajšave: AUCt = površina pod krivuljo plazemska koncentracija-čas od časa nič do zadnje merljive koncentracije; t1/2 = razpolovni čas; CL = očistek; FVIII:C = aktivnost FVIII; MRT = povprečni čas prisotnosti v krvnem obtoku
English: Allow the vial of lyophilised ReFacto AF and the pre-filled solvent syringe to reach room temperature.
Slovenian: Pustite, da se viala liofiliziranega zdravila ReFacto AF in napolnjena injekcijska brizga z vehiklom ogrejeta na sobno temperaturo.
English: ReFacto AF contains sodium
Slovenian: Zdravilo ReFacto AF vsebuje natrij
English: Do not freeze, in order to prevent damage to the pre-filled syringe.
Slovenian: Ne zamrzujte, da ne pride do poškodbe napolnjene injekcijske brizge.
English: Record on the outer carton the date ReFacto AF pre-filled syringe is removed from the refrigerator and set at room temperature (up to 25oC).
Slovenian: Na škatli zabeležite datum, ko ste zdravilo ReFacto AF vzeli iz hladilnika in shranili pri sobni temperaturi (do oC).
English: Remove the protective blue vented sterile cap from its packaging.
Slovenian: Vzemite zaščitno modro sterilno zaporko z odprtinami iz ovojnine.
English: Holding the ReFacto AF pre-filled syringe in an upright position, slowly advance the plunger rod until most, but not all, of the air is removed from the drug product chamber.
Slovenian: Držite napolnjeno injekcijsko brizgo zdravila ReFacto AF v pokončnem položaju in bat počasi potiskajte noter, dokler se iz razdelka, v katerem se nahaja zdravilo, ne odstrani večina zraka, vendar ne ves zrak.
English: Use immediately or within 3 hours of reconstitution or after removing the grey rubber tip cap from the syringe
Slovenian: Uporabite takoj oziroma najkasneje v 3 urah po rekonstituciji oziroma po odstranitvi sive gumijaste zaporke z brizge.
English: The lyophilised powder in the top chamber of the pre-filled syringe must be reconstituted with the solvent [sodium chloride 9 mg/mL (0.9%) solution] in the bottom chamber of the pre-filled syringe.
Slovenian: Liofilizirani prašek v zgornjem razdelku napolnjene injekcijske brizge morate rekonstituirati z vehiklom [9 mg/ml (0,9 %) raztopina natrijevega klorida] iz spodnjega razdelka napolnjene injekcijske brizge.
English: ReFacto AF is provided as a powder and solvent for solution for injection in a pre-filled syringe that contains the ReFacto AF powder in the top chamber and the solvent [sodium chloride 9 mg/ml (0.9%) solution] in the bottom chamber.
Slovenian: Zdravilo ReFacto AF je na voljo v obliki praška in vehikla za raztopino za injiciranje v napolnjeni injekcijski brizgi, ki vsebuje zdravilo ReFacto AF v obliki praška v zgornjem razdelku in vehikel [9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje] v spodnjem razdelku.
English: The product may be removed from refrigerated storage for one single period of maximum 3 months at room temperature (up to 25°C).
Slovenian: Zdravilo smete vzeti iz hladilnika za eno samo obdobje, ki ne sme biti daljše od 3 mesecev, pri sobni temperaturi (do 25 ºC).
English: België /Belgique / Belgien
Slovenian: België /Belgique / Belgien Pfizer S.A./N.V.
English: ReFacto AF is administered by intravenous infusion over several minutes after reconstitution of the lyophilised powder for injection with sodium chloride 9 mg/mL (0.9%) solution for injection (provided).
Slovenian: Zdravilo ReFacto AF dajemo z intravensko infuzijo v trajanju več minut po tem, ko smo raztopili liofilizirani prašek za injiciranje z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje (vehikel).
English: Aged <6 years Aged 6 to <12 years Cmax, IU/mLb
Slovenian: zvečanje aktivnosti, i.e./dl na i.e./kg stari < 6 let stari 6 do < 12 let
English: In a study of 37 paediatric PTPs, the pharmacokinetic parameters of ReFacto AF observed after a 50 IU/kg dose are shown in the table below.
Slovenian: Farmakokinetični parametri zdravila ReFacto AF, ki so jih opazili po odmerku 50 i.e./kg v študiji pri 37 pediatričnih PTP, so prikazani v spodnji preglednici.
English: The solution will be clear or slightly opalescent and colourless.
Slovenian: Raztopina mora biti bistra ali rahlo opalescentna in brezbarvna.
English: Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Use only the pre-filled syringe provided in the box for reconstitution.
Slovenian: Za pripravo zdravila uporabite samo napolnjeno injekcijsko brizgo, ki je priložena v škatli.
English: With the ReFacto AF pre-filled syringe remaining upright, swirl gently several times until the powder is dissolved.
Slovenian: Še naprej držite napolnjeno injekcijsko brizgo zdravila ReFacto AF v pokončnem položaju in jo nekajkrat rahlo zasučite, dokler se prašek ne raztopi.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj dispneja
English: ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent [sodium chloride 9 mg/mL (0.9%) solution] from the pre-filled syringe using the sterile vial adapter reconstitution device.
Slovenian: ReFacto AF 250 i.e., 500 i.e., 1000 i.e., 2000 i.e. prašek in vehikel za raztopino za injiciranje Vialo liofiliziranega praška za injekcijo zdravila morate rekonstituirati s priloženim vehiklom [9 mg/ml (0,9 %) raztopina natrijevega klorida] iz napolnjene injekcijske brizge s pomočjo sterilnega rekonstitucijskega nastavka za vialo.
English: The rate of administration should be determined by the patient's comfort level.
Slovenian: Hitrost injiciranja je odvisna od bolnikovega počutja.
English: • general feeling of being unwell
Slovenian: • splošno slabo počutje
English: Sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80, sodium chloride
Slovenian: Saharoza, kalcijev klorid dihidrat, L-histidin, polisorbat 80, natrijev klorid.
English: Investigations
Slovenian: Operacije
English: ReFacto AF contains 1.23 mmol (or 29 mg) sodium per vial of reconstituted powder.
Slovenian: Zdravilo ReFacto AF vsebuje 1,23 mmol (ali 29 mg) natrija na vialo rekonstituiranega praška.
English: The instructions below are for the use of multiple ReFacto AF pre-filled syringe kits with a 10 cc or larger luer lock syringe.
Slovenian: Spodnja navodila se nanašajo na uporabo več kompletov napolnjenih injekcijskih brizg zdravila ReFacto AF z 10 cm
English: Lift the package away from the adapter and discard the package.
Slovenian: Snemite ohišje z nastavka in ga zavrzite.
English: Anaphylactic reaction
Slovenian: Alergijske reakcije
English: The reconstituted product is to be injected intravenously over several minutes.
Slovenian: Pripravljeno zdravilo morate vbrizgavati v veno več minut.
English: N=13 35 IU/kg
Slovenian: n = 13 35 i.e./kg n = 14 33 i.e./kg n = 21 55 i.e./kg
English: Pyrexia
Slovenian: Pfizer
English: Once reconstituted, ReFacto AF should be inspected for particulate matter and discolouration prior to administration.
Slovenian: Po pripravi in pred uporabo je treba zdravilo ReFacto AF pregledati glede vsebnosti vidnih delcev ali obarvanosti.
English: Diarrhoea; vomiting; abdominal pain; nausea
Slovenian: Bolezni prebavil diareja; bruhanje; bolečine v trebuhu; navzea
English: Remove the luer-to-luer syringe connector from its package (luer-to-luer syringe connectors are not provided).
Slovenian: Vzemite nastavek za brizge »Luer-na-Luer« iz ovojnine (spojniki za brizge »Luer-na-Luer« niso priloženi).
English: ReFacto AF contains B-domain deleted recombinant coagulation factor VIII (moroctocog alfa).
Slovenian: Zdravilo ReFacto AF vsebuje rekombinantni koagulacijski faktor VIII brez domene B (moroktokog alfa).
English: Store and transport at 2°C - 8°C.
Slovenian: Zdravilo shranjujte in prevažajte pri temperaturi med 2 °C in 8 °C.
English: With the ReFacto AF pre-filled syringe on top, slowly depress the plunger rod until the contents empty into the 10 cc or larger luer lock syringe.
Slovenian: V položaju, ko se napolnjena injekcijska brizga zdravila ReFacto AF nahaja zgoraj, počasi potiskajte bat noter, dokler vsebina ne preide v 10 cm
English: The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF provided in a pre-filled syringe.
Slovenian: V nadaljevanju so opisana navodila za pripravo raztopine in način uporabe zdravila ReFacto AF v napolnjeni injekcijski brizgi.
English: Urticaria; rash; pruritus Hyperhidrosis
Slovenian: Bolezni kože in podkožja urtikarija; izpuščaj; pruritus hiperhidroza
English: ReFacto AF contains 1.23 mmol (or 29 mg) sodium per pre-filled syringe of reconstituted powder.
Slovenian: Zdravilo ReFacto AF vsebuje 1,23 mmol (ali 29 mg) natrija na napolnjeno injekcijsko brizgo rekonstituiranega praška.
English: A separate 10 cc or larger luer lock syringe (not included in this kit) may be used to draw back the reconstituted contents of each syringe (see
Slovenian: 3 ali večjo brizgo z nastavkom Luer lock, ki ni del tega kompleta (glejte Dodatna navodila).