FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII.
Slovenian: Pri bolnikih s hemofilijo A lahko nastanejo nevtralizirajoča protitelesa (inhibitorji) proti faktorju VIII.
English: Elevation of FVIII levels following administration, in particular with existing cardiovascular risk factors, might put a patient into the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
Slovenian: zlasti v primeru obstoječih srčnožilnih dejavnikov tveganja, predstavlja pri bolniku najmanj enako tveganje za zaporo žil ali miokardni infarkt kakor pri populaciji, ki nima hemofilije.
English: If this dose does not control your bleeding your doctor may consider giving you an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate.
Slovenian: se lahko vaš zdravnik odloči za dodatno zdravilo, koncentrat faktorja VIIa ali koncentrat (aktiviranega) protrombinskega kompleksa.
English: 1 vial with 2.5 ml water for injections.
Slovenian: OVOJNINAH VIALA S 2,5 ML VODE ZA INJEKCIJE
English: However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion".
Slovenian: V in vitro študijah je bilo zdravilo v PVC vrečkah, pripravljeno za kontinuirano infuzijo, pri temperaturi 30 °C kemijsko in fizikalno stabilno 24 ur.
English: No studies were performed on the mutagenic potential of Helixate NexGen, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of Helixate NexGen.
Slovenian: Študije mutagenega poteciala zdravila Helixate NexGen niso bile narejene, ker pri predhodniku zdravila Helixate NexGen v in vitro in in vivo študijah niso opazili mutagenega delovanja.
English: Solvent: water for injection, a clear, colourless solution.
Slovenian: Vehikel: voda za injekcije, bistra, brezbarvna raztopina Rekonstituirano zdravilo je bistra in brezbarvna raztopina.
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with Helixate NexGen.
Slovenian: Natančna navodila za pripravo in uporabo so v navodilu za uporabo ki je priložen zdravilu, Helixate
English: The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min).
Slovenian: Hitrost injiciranja naj bo prilagojena počutju bolnika (največja hitrost injiciranja je 2 ml/min).
English: For major surgery in particular, close monitoring of the substitution therapy by means of coagulation analysis must be carried out.
Slovenian: Predvsem pri večjih kirurških posegih je nujno potek nadomestnega zdravljenja skrbno spremljati z analizo strjevanja krvi.
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen can be used for continuous infusion in surgeries (pre-, during and postoperative).
Slovenian: se je pokazalo, da se zdravilo Helixate NexGen lahko uporablja kot kontinuirana infuzija pri kirurških posegih (pred, med in po posegu).
English: Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII.
Slovenian: Indukcija imunske tolerance (ITI - Immune Tolerance Induction) Podatke o indukciji imunske tolerance so zbrali pri bolnikih s hemofilijo A, pri katerih so nastali inhibitorji faktorja VIII.
English: Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Slovenian: Vialo z zdravilom s prozornim adapterjem nežno obračajte dokler se prašek popolnoma ne raztopi.
English: Do not use solutions containing visible particles or that are cloudy.
Slovenian: Ne uporabljajte raztopin z vidnimi delci ali motnih raztopin.
English: Puncture the vein and secure the venipuncture set with a plaster.
Slovenian: Punktirajte veno in z obližem pritrdite pribor za punkcijo vene.
English: When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation.
Slovenian: Po injiciranju faktorja VIII bolniku s hemofilijo se faktor VIII v krvnem obtoku veže na vWF.
English: Helixate NexGen has no influence on the ability to drive or to use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Helixate NexGen nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Slovenian: Vialo z vehiklom z modrim adapterjem Mix2Vial zavrzite.
English: Cases of recurrence of inhibitors (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.
Slovenian: Pri zamenjavi enega rekombinantnega faktorja VIII z drugim so pri predhodno zdravljenih bolnikih, ki so bili že več kot 100 dni izpostavljeni zdravilu in so imeli v anamnezi nastanek inhibitorjev, opazili primere ponovnega nastanka inhibitorjev (nizek titer).
English: Animal reproduction studies have not been conducted with Helixate NexGen.
Slovenian: Študij na živalih o vplivu zdravila Helixate NexGen na sposobnost razmnoževanja ni na voljo.
English: During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
Slovenian: V študijah niso pri nobenem od bolnikov opazili klinično pomembnih titrov protiteles proti beljakovinam miši in hrčkov, ki so v sledovih prisotne v zdravilu.
English: Only the provided administration sets can be used because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Slovenian: Če se uporabi drug pribor je lahko zdravljenje zaradi adsorpcije humanega rekombinantnega faktorja strjevanja krvi VIII na notranje stene nekaterih priborov za injiciranje neuspešno.
English: Expected factor VIII rise (% of normal) = 2 × administered IU body weight (kg)
Slovenian: Pričakovani dvig aktivnosti faktorja VIII (% normalne vrednosti) = 2 × dani odmerek (i.e.)
English: • Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Slovenian: • Pri uporabi tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
English: Powder: dry white to slightly yellow powder or cake.
Slovenian: Prašek: suh bel do rahlo rumen prašek ali pogača
English: During clinical studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
Slovenian: V kliničnih preskušanjih pri nobenem izmed bolnikov niso opazili klinično pomembnega nastanka protiteles proti beljakovinam miši in hrčkov, ki so v sledovih prisotne v zdravilu.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Slovenian: V takih primerih se priporoča posvetovanje z zdravstvenim osebjem, ki je specializirano za obravnavo hemofilije.
English: After reconstitution, the chemical and physical in-use stability has been demonstrated for 3 hours in in vitro studies.
Slovenian: V in vitro študijah je bilo po rekonstituciji zdravilo kemijsko in fizikalno stabilno 3 ure.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for the presence of factor VIII inhibitor should be performed.
Slovenian: Če pričakovane aktivnosti faktorja VIII v plazmi niso dosežene ali če krvavitve z ustreznim odmerkom ni mogoče nadzirati, je treba opraviti preiskave glede prisotnosti inhibitorjev faktorja VIII.
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: Laboratorijske preiskave Za doseganje in vzdrževanje ustrezne vrednosti faktorja VIII je priporočljivo, da se v rednih presledkih naredijo ustrezne laboratorijske preiskave plazme.
English: What Helixate NexGen 250 IU is and what it is used for What you need to know before you use Helixate NexGen 250 IU How to use Helixate NexGen 250 IU Possible side effects
Slovenian: Kaj je zdravilo Helixate NexGen 250 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen 250 i.e. Kako uporabljati zdravilo Helixate NexGen 250 i.e.
English: BATCH NUMBER Lot
Slovenian: Luer Lock.
English: What Helixate NexGen 2000 IU is and what it is used for
Slovenian: Kaj je zdravilo Helixate NexGen 2000 i.e. in za kaj ga uporabljamo
English: Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h.Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).
Slovenian: Povprečni začetni očistek pri 14-ih odraslih bolnikih pri katerih je bil narejen večji kirurški poseg in so dobili kontinuirano infuzijo, je 188 ml/h, kar ustreza 3,0 ml/h/kg (območje 1,6 - 4,6 ml/h/kg).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use, single dose administration only.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko uporabo, enkratni odmerek za injiciranje Pred uporabo preberite priloženo navodilo!
English: INFORMATION IN BRAILLE Helixate NexGen 2000
Slovenian: PODATKI V BRAILLOVI PISAVI Helixate NexGen 2000
English: During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
Slovenian: Za ugotavljanje primernega odmerka in pogostosti dajanja infuzij se med zdravljenjem svetuje redno določanje vrednosti faktorja VIII.
English: Infusion rate IU/h/kg
Slovenian: telesna masa (kg)
English: If you want to stop using Helixate NexGen 1000 IU Do not stop using Helixate NexGen without consulting your doctor.
Slovenian: Če želite prenehati uporabljati zdravilo Helixate NexGen 1000 i.e. Ne prenehajte uporabljati zdravila Helixate NexGen, ne da bi se prej posvetovali z vašim zdravnikom.
English: Do not use Helixate NexGen if you notice visible particulate matter or turbidity.
Slovenian: Ne uporabite zdravila Helixate NexGen, če v raztopini opazite vidne delce ali je raztopina motna.
English: Allergic type hypersensitivity reactions are possible with Helixate NexGen.
Slovenian: Preobčutljivost Po uporabi zdravila Helixate NexGen se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Slovenian: Zdravljenje naj traja vsaj 1 dan, dokler se krvavitev ne ustavi
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: MedDRA (uporabljen je najustreznejši izraz po klasifikaciji MedDRA).
English: If you are using Helixate NexGen to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Slovenian: Če zdravilo Helixate NexGen 1000 i.e. uporabljate za preprečevanje krvavitev (profilakso), bo velikost odmerka za vas izračunal zdravnik.
English: Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 1000 IU.
Slovenian: Pribor za rekonstitucijo in aplikacijo je priložen v vsakem pakiranju zdravila Helixate NexGen 1000 i.e..
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of Helixate NexGen 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: What Helixate NexGen 2000 IU is and what it is used for What you need to know before you use Helixate NexGen 2000 IU How to use Helixate NexGen 2000 IU Possible side effects
Slovenian: Kaj je zdravilo Helixate NexGen 2000 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen 2000 i.e. Kako uporabljati zdravilo Helixate NexGen 2000 i.e.
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: tahikardijo, tiščanje v prsnem košu, ščemenje, bruhanje, sopenje), ki lahko v nekaterih primerih napredujejo do hude anafilakse (tudi šok).
English: These therapies should be directed by physicians with experience in the care of patients with haemophilia.
Slovenian: Zdravljenje mora potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo.
English: Helixate NexGen powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Slovenian: Prašek Helixate NexGen se lahko raztopi le v priloženem vehiklu (5,0 ml vode za injekcije).
English: Other medicines and Helixate NexGen 250 IU
Slovenian: Druga zdravila in zdravilo Helixate NexGen 250 i.e.
English: INFORMATION IN BRAILLE Helixate NexGen 250
Slovenian: PODATKI V BRAILLOVI PISAVI Helixate NexGen 250
English: Solvent: water for injections.
Slovenian: Vehikel: voda za injekcije
English: Rare: may affect up to 1 in 1,000 users
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: What Helixate NexGen 250 IU is and what it is used for
Slovenian: Kaj je zdravilo Helixate NexGen 250 i.e. in za kaj ga uporabljamo
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Slovenian: Vialo z vehiklom, na katero je pritrjen komplet Mix2Vial, obrnite in potisnite konico prozornega adapterja naravnost navzdol skozi zamašek viale z zdravilom.
English: Phone: +356 2397 6333
Slovenian: AM Mangion Ltd. Phone: +356 2397 6333
English: If you forget to use Helixate NexGen 250 IU
Slovenian: Če ste pozabili uporabiti zdravilo Helixate NexGen 250 i.e.
English: Other medicines and Helixate NexGen 2000 IU
Slovenian: Druga zdravila in zdravilo Helixate NexGen 2000 i.e.
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting.
Slovenian: Medtem ko je viala z zdravilom v pokončnem položaju, pritrdite brizgo na Mix2Vial
English: INFORMATION IN BRAILLE Helixate NexGen 1000
Slovenian: PODATKI V BRAILLOVI PISAVI Helixate NexGen 1000
English: Helixate NexGen powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Slovenian: Prašek Helixate NexGen se lahko raztopi le v priloženem vehiklu (2,5 ml vode za injekcije).
English: How to use Helixate NexGen 250 IU
Slovenian: Kako uporabljati zdravilo Helixate NexGen 250 i.e.
English: No interactions of Helixate NexGen with other medicinal products have been reported.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O medsebojnem delovanju zdravila Helixate NexGen z drugimi zdravili ni poročil.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer Pharma AG
English: INFORMATION IN BRAILLE Helixate NexGen 500
Slovenian: PODATKI V BRAILLOVI PISAVI Helixate NexGen 500
English: What is in this leaflet
Slovenian: * glejte poglavje spodaj
English: What Helixate NexGen 1000 IU is and what it is used for
Slovenian: Kaj je zdravilo Helixate NexGen 1000 i.e. in za kaj ga uporabljamo
English: Other medicines and Helixate NexGen 3000 IU
Slovenian: Druga zdravila in zdravilo Helixate NexGen 3000 i.e.
English: • You must use aseptic conditions (meaning clean and germ free) during reconstitution and administration.
Slovenian: • Rekonstitucija in uporaba zdravila morata potekati v aseptičnih pogojih (t.j.
English: What you need to know before you use Helixate NexGen 250 IU
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen 250 i.e. Ne uporabljajte zdravila Helixate NexGen 250 i.e.
English: If you forget to use Helixate NexGen 2000 IU
Slovenian: Če ste pozabili uporabiti zdravilo Helixate NexGen 2000 i.e.
English: What Helixate NexGen 500 IU is and what it is used for What you need to know before you use Helixate NexGen 500 IU How to use Helixate NexGen 500 IU Possible side effects
Slovenian: Kaj je zdravilo Helixate NexGen 500 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen 500 i.e. Kako uporabljati zdravilo Helixate NexGen 500 i.e.
English: Take special care with Helixate NexGen 250 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila Helixate NexGen 250 i.e.
English: The vial with powder contains 250 IU (International Units) of octocog alfa.
Slovenian: Viala s praškom vsebuje 250 i.e. (mednarodnih enot) oktokoga alfa.
English: INFORMATION IN BRAILLE Helixate NexGen 3000
Slovenian: PODATKI V BRAILLOVI PISAVI Helixate NexGen 3000
English: How to use Helixate NexGen 2000 IU
Slovenian: Kako uporabljati zdravilo Helixate NexGen 2000 i.e.
English: Take special care with Helixate NexGen 2000 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila Helixate NexGen 2000 i.e.
English: If you forget to use Helixate NexGen 1000 IU
Slovenian: Če ste pozabili uporabiti zdravilo Helixate NexGen 1000 i.e.
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 2000 IU powder and solvent for solution for injection.
Slovenian: IME ZDRAVILA Helixate NexGen 2000 i.e. prašek in vehikel za raztopino za injiciranje
English: Take special care with Helixate NexGen 500 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila Helixate NexGen 500 i.e.
English: Other medicines and Helixate NexGen 1000 IU
Slovenian: Druga zdravila in zdravilo Helixate NexGen 1000 i.e.
English: Minor including tooth extraction
Slovenian: kirurški posegi manjši posegi tudi izdrtje zob
English: If the expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
Slovenian: Če se z odmerkom zdravila ne doseže pričakovane aktivnosti faktorja VIII v plazmi, ali se krvavitev kljub primernemu odmerku ne ustavi, je treba preveriti ali je v bolnikovi krvi prisoten inhibitor faktorja VIII.
English: Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII.
Slovenian: Za ugotavljanje biološke aktivnosti faktorja VIII in vitro se običajno uporablja metoda določanja aktiviranega parcialnega tromboplastinskega časa (APTČ), ki je pri vseh hemofilikih podaljšan.
English: How to use Helixate NexGen 3000 IU
Slovenian: Kako uporabljati zdravilo Helixate NexGen 3000 i.e.
English: Finally, apply a small pressure dressing to the wound.
Slovenian: Potem na rano namestite majhno kompresijsko obvezo.
English: How to use Helixate NexGen 500 IU
Slovenian: Kako uporabljati zdravilo Helixate NexGen 500 i.e.
English: What Helixate NexGen 3000 IU is and what it is used for What you need to know before you use Helixate NexGen 3000 IU How to use Helixate NexGen 3000 IU Possible side effects
Slovenian: Kaj je zdravilo Helixate NexGen 3000 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen 3000 i.e. Kako uporabljati zdravilo Helixate NexGen 3000 i.e.
English: What Helixate NexGen 500 IU is and what it is used for
Slovenian: Kaj je zdravilo Helixate NexGen 500 i.e. in za kaj ga uporabljamo
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa (100 IU/ml after reconstitution).
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 250 i.e. oktokoga alfa (po rekonstituciji 100 i.e./ml).
English: Clearance: 3 ml/h/kg
Slovenian: 3,0 ml/h/kg (območje 1,6 - 4,6 ml/h/kg).
English: If you forget to use Helixate NexGen 3000 IU
Slovenian: Če ste pozabili uporabiti zdravilo Helixate NexGen 3000 i.e.
English: If you have used more Helixate NexGen 250 IU than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila Helixate NexGen 250 i.e., kot bi smeli, prosimo o tem obvestite vašega zdravnika.
English: If you forget to use Helixate NexGen 500 IU
Slovenian: Če ste pozabili uporabiti zdravilo Helixate NexGen 500 i.e.
English: How to use Helixate NexGen 1000 IU
Slovenian: Kako uporabljati zdravilo Helixate NexGen 1000 i.e.
English: The vial with powder contains 2000 IU (International Units) of octocog alfa.
Slovenian: Viala s praškom vsebuje 2000 i.e. (mednarodnih enot) oktokoga alfa.
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 250 IU powder and solvent for solution for injection.
Slovenian: IME ZDRAVILA Helixate NexGen 250 i.e. prašek in vehikel za raztopino za injiciranje
English: What you need to know before you use Helixate NexGen 500 IU
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen 500 i.e. Ne uporabljajte zdravila Helixate NexGen 500 i.e.
English: Do not pass it on to others.
Slovenian: se ga ne sme uporabiti.
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial with powder for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA prašek in vehikel za raztopino za injiciranje
English: Other medicines and Helixate NexGen 500 IU
Slovenian: Druga zdravila in zdravilo Helixate NexGen 500 i.e.
English: Take special care with Helixate NexGen 1000 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila Helixate NexGen 1000 i.e.
English: What Helixate NexGen 2000 IU looks like and content of the pack
Slovenian: Izgled zdravila Helixate NexGen 2000 i.e. in vsebina pakiranja
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, nausea, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: vročinske oblive, generalizirano urtikarijo, glavobol, izpuščaj, hipotenzijo, letargijo, navzeo, nemir,
English: What Helixate NexGen 1000 IU is and what it is used for What you need to know before you use Helixate NexGen 1000 IU How to use Helixate NexGen 1000 IU Possible side effects
Slovenian: Kaj je zdravilo Helixate NexGen 1000 i.e. in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen 1000 i.e. Kako uporabljati zdravilo Helixate NexGen 1000 i.e.
English: What you need to know before you use Helixate NexGen 2000 IU
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen 2000 i.e. Ne uporabljajte zdravila Helixate NexGen 2000 i.e.
English: Take special care with Helixate NexGen 3000 IU
Slovenian: Bodite posebno pozorni pri uporabi zdravila Helixate NexGen 3000 i.e.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa (600 IU/ml after reconstitution).
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3000 i.e. oktokoga alfa (po rekonstituciji 600 i.e./ml).
English: If you have used more Helixate NexGen 2000 IU than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila Helixate NexGen 2000 i.e., kot bi smeli, prosimo o tem obvestite vašega zdravnika.
English: Usually, the substitution therapy with Helixate NexGen is a life-time treatment.
Slovenian: Nadomestno zdravljenje z zdravilom Helixate NexGen 2000 i.e. je običajno potrebno celo življenje.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa (600 IU/ml after reconstitution).
Slovenian: 1 viala vsebuje 3000 i.e. oktokoga alfa (po rekonstituciji 600 i.e./ml).
English: Haemorrhage Early haemarthrosis, muscle bleed or oral bleed
Slovenian: krvavitev manjše krvavitve v sklepe, v mišice ali ustno votlino