FrancophonIA/ELRC3.0 huggingface dataset:
English: Unscrew the syringe to disconnect the vial (I).
Slovenian: Odvijte brizgo, da ločite vialo (I).
English: The product contains traces of mouse and hamster proteins and human proteins other than factor VIII (see section 5.1).
Slovenian: Zdravilo vsebuje sledi beljakovin miši in hrčkov ter poleg faktorja VIII tudi sledi humanih beljakovin
English: The degree and duration of aPTT normalisation observed after administration of KOGENATE Bayer is similar to that achieved with plasma-derived factor VIII.
Slovenian: Stopnja in trajanje normalizacije APTČ sta pri zdravilu KOGENATE Bayer podobna kot pri faktorju
English: The venipuncture set provided with the product must not be used for drawing blood because it contains an in-line filter.
Slovenian: Pribora za vensko punkcijo, priloženega zdravilu, ni mogoče uporabiti za odvzem krvi, ker že vključuje filter.
English: Inject the solvent into the vial containing the powder by slowly pushing the syringe plunger down (F).
Slovenian: Injicirajte vehikel v vialo s praškom s počasnim potiskanjem bata injekcijske brizge navzdol (F).
English: Do not use solutions that contain visible particles or that are cloudy (G).
Slovenian: Če raztopina vsebuje vidne delce ali je motna, je ne uporabljajte (G).
English: Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for KOGENATE Bayer in laboratory animals (mouse, rat, rabbit, and dog).
Slovenian: Tudi pri dajanju odmerkov, ki so bili nekajkrat večji od priporočenega kliničnega odmerka (glede na telesno maso) pri različnih laboratorijskih živalih (miš, podgana, kunec in pes) niso opazili nobenih akutnih ali subakutnih toksičnih učinkov zdravila KOGENATE Bayer.
English: Reconstitute the desired amount of product, repeating steps 2.
Slovenian: Rekonstituirajte želeno količino zdravila tako, da ponovite korake od 2 do 9, vzemite novo brizgo in jo pritrdite na pribor za vensko punkcijo.
English: Remove protective cap from the vial (A) then clean the rubber stopper with a sterile swab (or use an antiseptic spray).
Slovenian: Gumijast zamašek očistite s sterilnim tamponom (ali uporabite antiseptično pršilo).
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.
Slovenian: Natančna navodila za pripravo in uporabo so v navodilu za uporabo ki je priloženo zdravilu, KOGENATE Bayer.
English: The active substance is human coagulation factor VIII (octocog alfa) produced by recombinant DNA technology.
Slovenian: Zdravilna učinkovina je humani koagulacijski faktor VIII (oktokog alfa) izdelan z rekombinantno
English: Invert vial/syringe and transfer the solution into syringe by drawing the plunger out slowly and smoothly (H).
Slovenian: Obrnite vialo/injekcijsko brizgo in prenesite raztopino v brizgo tako, da enakomerno in počasi izvlečete bat brizge in jo napolnite (H).
English: Holding the adapter housing, place over the product vial and firmly press down (B).
Slovenian: Ohišje adapterja postavite nad vialo z zdravilom in pritisnite navzdol (B).
English: Systemic Hypersensitivit y reactions (including anaphylactic reaction, nausea, blood pressure abnormal and, dizziness)
Slovenian: sistemske preobčutljivos tne reakcije (tudi anafilaksija, navzea, nenormalen krvni tlak in omotica)
English: KOGENATE Bayer has no influence on the ability to drive or to use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo KOGENATE Bayer nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Animal reproduction studies have not been conducted with KOGENATE Bayer.
Slovenian: Študij na živalih o vplivu zdravila KOGENATE Bayer na sposobnost razmnoževanja ni na voljo.
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative).
Slovenian: se je pokazalo, da se zdravilo KOGENATE Bayer lahko uporablja kot kontinuirana infuzija pri kirurških posegih (pred, med in po posegu).
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 with recombinant factor VIII products and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: Pri zdravilih, ki vsebujejo rekombinantni faktor VIII, so poročali o preobčutljivostnih ali alergijskih reakcijah (ki lahko vključujejo angioedem, skelenje in zbadanje na mestu infundiranja, mrzlico, vročinske oblive, generalizirano urtikarijo, glavobol, izpuščaj, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, tiščanje v prsnem košu, ščemenje, bruhanje, sopenje), ki lahko v nekaterih primerih napredujejo do hude anafilakse (tudi šok).
English: 1 vial with powder for solution for injection.
Slovenian: 1 viala s praškom za raztopino za injiciranje
English: Ensure that the entire contents of the vial are drawn into the syringe.
Slovenian: Preverite, da je celotna količina viale izpraznjena v brizgo.
English: Ensure that the entire content of the vial is drawn into the syringe.
Slovenian: Prepričajte se, da je v brizgi vsa vsebina viale.
English: • two plasters
Slovenian: • dva obliža.
English: Attach the syringe to the venipuncture set by screwing it clockwise and ensure that no blood enters the syringe (J).
Slovenian: Nastavite brizgo na pribor za vensko punkcijo tako, da jo privijete v smeri urnega kazalca, in preverite, da vanjo ni prišla kri (J).
English: Inject the diluent by slowly pushing down on the plunger rod (G).
Slovenian: Injicirajte vehikel tako, da bat brizge počasi potiskate navzdol (G).
English: KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Slovenian: za katerega je znano, da zveča hitrost ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih (PVC) materialov.
English: Attach the pre-filled syringe to the threaded vial adapter by turning clockwise (F).
Slovenian: Pritrdite napolnjeno injekcijsko brizgo na navojni adapter za vialo tako, da ga obračate v smeri urinega kazalca (F).
English: • one vial plus Bio-Set device, containing powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper plus transfer device with protective cap [Bio-Set])
Slovenian: • 1 vialo, ki vsebuje prašek in pribor Bio-Set (10-mililitrska viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom brez lateksa in pribor za prenos vehikla z zaščitno zaporko [Bio-Set])
English: What KOGENATE Bayer 250 IU is and what it is used for What you need to know before you use KOGENATE Bayer 250 IU How to use KOGENATE Bayer 250 IU Possible side effects
Slovenian: Kaj je zdravilo KOGENATE Bayer 250 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 250 i.e. Kako uporabljati zdravilo KOGENATE Bayer 250 i.e.
English: INFORMATION IN BRAILLE KOGENATE Bayer 2000
Slovenian: PODATKI V BRAILLOVI PISAVI KOGENATE Bayer 2000
English: If you are using KOGENATE Bayer to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Slovenian: Če zdravilo KOGENATE Bayer 2000 i.e. uporabljate za preprečevanje krvavitev (profilakso), bo velikost odmerka za vas izračunal zdravnik.
English: The adapter will snap over the vial cap. Do not remove the adapter housing at this step.
Slovenian: Na tej stopnji ne odstranite ohišja adapterja.
English: Then, strongly press down the fingerplate near the syringe tip using your thumb and index finger (C) until the finger plate meets the top edge of the Bio-Set.
Slovenian: Potem s palcem in kazalcem (C) zaščitno steklo blizu konca injekcijske brizge močno potisnite navzdol.
English: INFORMATION IN BRAILLE KOGENATE Bayer 250
Slovenian: PODATKI V BRAILLOVI PISAVI KOGENATE Bayer 250
English: This indicates that the system is activated (D).
Slovenian: Ko bo doseglo zgornji rob pribora Bio-Set, se bo sistem aktiviral (D).
English: Warm both unopened vial and syringe in your hands to a comfortable temperature (do not exceed 37 °C).
Slovenian: Z rokami segrejte neodprto vialo in injekcijsko brizgo na primerno temperaturo (ne več kot
English: What KOGENATE Bayer 250 IU is and what it is used for
Slovenian: Kaj je zdravilo KOGENATE Bayer 250 i.e. in za kaj ga uporabljamo
English: It is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained.
Slovenian: Za doseganje in vzdrževanje ustrezne vrednosti faktorja VIII je priporočljivo, da se v rednih presledkih naredijo ustrezne laboratorijske preiskave plazme.
English: If you forget to use KOGENATE Bayer 250 IU
Slovenian: Če ste pozabili uporabiti zdravilo KOGENATE Bayer 250 i.e.
English: INFORMATION IN BRAILLE KOGENATE Bayer 1000
Slovenian: PODATKI V BRAILLOVI PISAVI KOGENATE Bayer 1000
English: How to use KOGENATE Bayer 250 IU
Slovenian: Kako uporabljati zdravilo KOGENATE Bayer 250 i.e.
English: What KOGENATE Bayer 2000 IU is and what it is used for
Slovenian: Kaj je zdravilo KOGENATE Bayer 2000 i.e. in za kaj ga uporabljamo
English: INFORMATION IN BRAILLE KOGENATE Bayer 3000
Slovenian: PODATKI V BRAILLOVI PISAVI KOGENATE Bayer 3000
English: Connect the plunger rod to the syringe by screwing it into the rubber stopper (E).
Slovenian: Bat injekcijske brizge vstavite v brizgo s privijanjem v gumijast zamašek (E).
English: What KOGENATE Bayer 2000 IU is and what it is used for What you need to know before you use KOGENATE Bayer 2000 IU How to use KOGENATE Bayer 2000 IU Possible side effects
Slovenian: Kaj je zdravilo KOGENATE Bayer 2000 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 2000 i.e. Kako uporabljati zdravilo KOGENATE Bayer 2000 i.e.
English: Take special care with KOGENATE Bayer 250 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila KOGENATE Bayer 250 i.e.
English: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
Slovenian: • 1 vialo s praškom (10-mililitrska viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom brez lateksa in z gumijasto zaporko)
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of KOGENATE Bayer per kg body weight at intervals of 2 to 3 days.
Slovenian: Za dolgotrajno preprečevanje krvavitev pri bolnikih s hudo hemofilijo A so običajni odmerki od 20 do
English: INFORMATION IN BRAILLE KOGENATE Bayer 500
Slovenian: PODATKI V BRAILLOVI PISAVI KOGENATE Bayer 500
English: How to use KOGENATE Bayer 500 IU
Slovenian: Kako uporabljati zdravilo KOGENATE Bayer 500 i.e.
English: 1 pre-filled syringe with 2.5 ml water for injections with separate plunger rod.
Slovenian: 1 napolnjena injekcijska brizga, ki vsebuje 2,5 ml vode za injekcije z ločenim batom brizge 1 adapter za vialo
English: What KOGENATE Bayer 500 IU is and what it is used for What you need to know before you use KOGENATE Bayer 500 IU How to use KOGENATE Bayer 500 IU Possible side effects
Slovenian: Kaj je zdravilo KOGENATE Bayer 500 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 500 i.e. Kako uporabljati zdravilo KOGENATE Bayer 500 i.e.
English: How to use KOGENATE Bayer 2000 IU
Slovenian: Kako uporabljati zdravilo KOGENATE Bayer 2000 i.e.
English: Take special care with KOGENATE Bayer 500 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila KOGENATE Bayer 500 i.e.
English: Common: may affect up to 1 in 10 users
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: How to use KOGENATE Bayer 1000 IU
Slovenian: Kako uporabljati zdravilo KOGENATE Bayer 1000 i.e.
English: What KOGENATE Bayer 3000 IU is and what it is used for
Slovenian: Kaj je zdravilo KOGENATE Bayer 3000 i.e. in za kaj ga uporabljamo
English: If you forget to use KOGENATE Bayer 3000 IU
Slovenian: Če ste pozabili uporabiti zdravilo KOGENATE Bayer 3000 i.e.
English: If you forget to use KOGENATE Bayer 500 IU
Slovenian: Če ste pozabili uporabiti zdravilo KOGENATE Bayer 500 i.e.
English: The rate of administration should be determined by the patient's comfort level (maximal rate of injection: 2 ml/min).
Slovenian: Hitrost injiciranja naj bo prilagojena počutju bolnika (največja hitrost injiciranja je 2 ml/min).
English: 1 pre-filled syringe with 5.0 ml water for injections with separate plunger rod.
Slovenian: 1 napolnjena injekcijska brizga, ki vsebuje 5,0 ml vode za injekcije z ločenim batom brizge 1 adapter za vialo
English: What you need to know before you use KOGENATE Bayer 250 IU
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 250 i.e. Ne uporabljajte zdravila KOGENATE Bayer 250 i.e.
English: Take special care with KOGENATE Bayer 2000 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila KOGENATE Bayer 2000 i.e.
English: If you forget to use KOGENATE Bayer 2000 IU
Slovenian: Če ste pozabili uporabiti zdravilo KOGENATE Bayer 2000 i.e.
English: How to use KOGENATE Bayer 3000 IU
Slovenian: Kako uporabljati zdravilo KOGENATE Bayer 3000 i.e.
English: What KOGENATE Bayer 500 IU is and what it is used for
Slovenian: Kaj je zdravilo KOGENATE Bayer 500 i.e. in za kaj ga uporabljamo
English: What KOGENATE Bayer 3000 IU is and what it is used for What you need to know before you use KOGENATE Bayer 3000 IU How to use KOGENATE Bayer 3000 IU Possible side effects
Slovenian: Kaj je zdravilo KOGENATE Bayer 3000 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 3000 i.e. Kako uporabljati zdravilo KOGENATE Bayer 3000 i.e.
English: If you have used more KOGENATE Bayer 250 IU than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila KOGENATE Bayer 250 i.e., kot bi smeli, prosimo o tem obvestite vašega zdravnika.
English: Take special care with KOGENATE Bayer 1000 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila KOGENATE Bayer 1000 i.e.
English: • one pre-filled syringe with 2.5 ml solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper)
Slovenian: • 1 napolnjeno injekcijsko brizgo s 2,5 ml vehikla (valj iz prozornega stekla tipa 1 s sivim bromobutilnim gumijastim zamaškom brez lateksa)
English: What KOGENATE Bayer 2000 IU looks like and content of the pack
Slovenian: Izgled zdravila KOGENATE Bayer 2000 i.e. in vsebina pakiranja
English: What KOGENATE Bayer 1000 IU is and what it is used for
Slovenian: Kaj je zdravilo KOGENATE Bayer 1000 i.e. in za kaj ga uporabljamo
English: If you forget to use KOGENATE Bayer 1000 IU
Slovenian: Če ste pozabili uporabiti zdravilo KOGENATE Bayer 1000 i.e.
English: Hold the pre-filled sterile water for injection (SWFI) syringe upright, grasp the plunger rod per the diagram and attach the rod by turning it firmly clockwise into the threaded stopper (C).
Slovenian: navpično, primite bat brizge, kot je narisano, in pritrdite bat tako, da ga čvrsto obrnete v smeri urinega kazalca v izrezan zamašek (C).
English: • one pre-filled syringe with 5.0 ml solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper)
Slovenian: • 1 napolnjeno injekcijsko brizgo s 5,0 ml vehikla (valj iz prozornega stekla tipa 1 s sivim bromobutilnim gumijastim zamaškom brez lateksa)
English: Usually, the substitution therapy with KOGENATE Bayer is a life-time treatment.
Slovenian: Nadomestno zdravljenje z zdravilom KOGENATE Bayer 3000 i.e. je običajno potrebno celo življenje.
English: Take special care with KOGENATE Bayer 3000 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila KOGENATE Bayer 3000 i.e.
English: What you need to know before you use KOGENATE Bayer 2000 IU
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 2000 i.e. Ne uporabljajte zdravila KOGENATE Bayer 2000 i.e.
English: Other medicines and KOGENATE Bayer 500 IU Interactions with other medicines are not known.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O medsebojnem delovanju zdravila KOGENATE Bayer z drugimi zdravili ni poročil.
English: What KOGENATE Bayer 500 IU looks like and content of the pack
Slovenian: Izgled zdravila KOGENATE Bayer 500 i.e. in vsebina pakiranja
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 2000 IU.
Slovenian: Pribor za rekonstitucijo in aplikacijo je priložen v vsakem pakiranju zdravila KOGENATE Bayer 2000 i.e..
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 250 IU powder and solvent for solution for injection.
Slovenian: IME ZDRAVILA KOGENATE Bayer 250 i.e. prašek in vehikel za raztopino za injiciranje
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 1000 IU.
Slovenian: Pribor za rekonstitucijo in aplikacijo je priložen v vsakem pakiranju zdravila KOGENATE Bayer 1000 i.e..
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 500 IU.
Slovenian: Pribor za rekonstitucijo in aplikacijo je priložen v vsakem pakiranju zdravila KOGENATE Bayer 500 i.e..
English: What KOGENATE Bayer 1000 IU is and what it is used for What you need to know before you use KOGENATE Bayer 1000 IU How to use KOGENATE Bayer 1000 IU Possible side effects
Slovenian: Kaj je zdravilo KOGENATE Bayer 1000 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 1000 i.e. Kako uporabljati zdravilo KOGENATE Bayer 1000 i.e.
English: What you need to know before you use KOGENATE Bayer 500 IU
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 500 i.e. Ne uporabljajte zdravila KOGENATE Bayer 500 i.e.
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 500 IU powder and solvent for solution for injection.
Slovenian: IME ZDRAVILA KOGENATE Bayer 500 i.e. prašek in vehikel za raztopino za injiciranje
English: If you have used more KOGENATE Bayer 3000 IU than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila KOGENATE Bayer 3000 i.e., kot bi smeli, prosimo o tem obvestite vašega zdravnika.
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 2000 IU powder and solvent for solution for injection.
Slovenian: IME ZDRAVILA KOGENATE Bayer 2000 i.e. prašek in vehikel za raztopino za injiciranje
English: If you use more KOGENATE Bayer 250 IU than you should No cases of overdose with recombinant coagulation factor VIII have been reported.
Slovenian: Če ste uporabili večji odmerek zdravila KOGENATE Bayer 250 i.e. kot bi smeli Ni poročil o prevelikem odmerjanju rekombinantnega koagulacijskega faktorja VIII.
English: If you have used more KOGENATE Bayer 500 IU than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila KOGENATE Bayer 500 i.e., kot bi smeli, prosimo o tem obvestite vašega zdravnika.
English: What KOGENATE Bayer 3000 IU looks like and content of the pack
Slovenian: Izgled zdravila KOGENATE Bayer 3000 i.e. in vsebina pakiranja
English: One ml of KOGENATE Bayer 3000 IU contains approximately 600 IU (3000 IU / 5.0 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Slovenian: 1 ml zdravila KOGENATE Bayer vsebuje po rekonstituciji približno 600 i.e. (3000 i.e./ 5,0 ml) humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
English: If you have used more KOGENATE Bayer 2000 IU than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila KOGENATE Bayer 2000 i.e., kot bi smeli, prosimo o tem obvestite vašega zdravnika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/143/008
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/143/008
English: What you need to know before you use KOGENATE Bayer 1000 IU
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 1000 i.e. Ne uporabljajte zdravila KOGENATE Bayer 1000 i.e.
English: What you need to know before you use KOGENATE Bayer 3000 IU
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo KOGENATE Bayer 3000 i.e. Ne uporabljajte zdravila KOGENATE Bayer 3000 i.e.
English: One ml of KOGENATE Bayer 1000 IU contains approximately 400 IU (1000 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Slovenian: 1 ml zdravila KOGENATE Bayer vsebuje po rekonstituciji približno 400 i.e. (1000 i.e./ 2,5 ml) humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) in the prefilled syringe and the vial adapter.
Slovenian: Prašek KOGENATE Bayer lahko raztopite le v priloženem vehiklu (5,0 ml vode za injekcije) v napolnjeni injekcijski brizgi in z adapterjem za vialo.
English: • two dry swabs
Slovenian: • dva suha tampona
English: What KOGENATE Bayer 1000 IU looks like and content of the pack
Slovenian: Izgled zdravila KOGENATE Bayer 1000 i.e. in vsebina pakiranja
English: Use only the medical devices (powder vial with Bio-Set device, pre-filled syringe containing solvent and venipuncture set) for reconstitution and administration that are provided with each package of this medicine.
Slovenian: Za rekonstitucijo in injiciranje tega zdravila lahko uporabite samo pribor, ki je priložen v vsakem pakiranju zdravila (viala s praškom in pribor Bio-Set, napolnjena injekcijska brizga z vehiklom in pribor za vensko punkcijo).
English: One ml of KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Slovenian: 1 ml zdravila KOGENATE Bayer vsebuje po rekonstituciji približno 100 i.e. (250 i.e./ 2,5 ml) humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) in the prefilled syringe and the integrated transfer device (Bio-Set).
Slovenian: Prašek KOGENATE Bayer se lahko raztopi le v priloženem vehiklu (5,0 ml vode za injekcije) v napolnjeni injekcijski brizgi in s priloženim priborom za prenos vehikla (Bio-Set).
English: Medical devices for reconstitution and administration are provided with each package of KOGENATE Bayer 3000 IU.
Slovenian: Pribor za rekonstitucijo in aplikacijo je priložen v vsakem pakiranju zdravila KOGENATE Bayer 3000 i.e..
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) in the prefilled syringe and the integrated transfer device (Bio-Set).
Slovenian: Prašek KOGENATE Bayer se lahko raztopi le v priloženem vehiklu (2,5 ml vode za injekcije) v napolnjeni injekcijski brizgi in s priloženim priborom za prenos vehikla (Bio-Set).
English: One ml of KOGENATE Bayer 2000 IU contains approximately 400 IU (2000 IU / 5.0 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Slovenian: 1 ml zdravila KOGENATE Bayer vsebuje po rekonstituciji približno 400 i.e. (2000 i.e./ 5,0 ml) humanega koagulacijskega faktorja VIII (INN: oktokog alfa).
English: If you have used more KOGENATE Bayer 1000 IU than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila KOGENATE Bayer 1000 i.e., kot bi smeli, prosimo o tem obvestite vašega zdravnika.
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 1000 IU powder and solvent for solution for injection.
Slovenian: IME ZDRAVILA KOGENATE Bayer 1000 i.e. prašek in vehikel za raztopino za injiciranje
English: NAME OF THE MEDICINAL PRODUCT KOGENATE Bayer 3000 IU powder and solvent for solution for injection.
Slovenian: IME ZDRAVILA KOGENATE Bayer 3000 i.e. prašek in vehikel za raztopino za injiciranje