natgillin/translations-raw huggingface dataset:
Helixate NexGen 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. 
Zdravilo Helixate NexGen kot pomožno snov vsebuje majhno količino polisorbata 80, za katerega je znano, da zveča hitrost ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih (PVC) materialov.
With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully into two pieces. 
Z eno roko primite komplet Mix2Vial na strani kjer je zdravilo, z drugo roko pa na strani kjer je vehikel in razstavite komplet na dva dela.
• formation of neutralising antibodies to factor VIII (inhibitors) in previously treated patients 
• nastanek nevtralizirajočih protiteles proti faktorju VIII (inhibitorjev) pri predhodno zdravljenih bolnikih
• If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing a rare severe sudden allergic reaction (a socalled anaphylactic reaction) to this medicine. 
• Če imate občutek tiščanja v prsih, vrtoglavico, omedlevico, občutek siljenja na bruhanje ali ste omotični kadar stojite, je možno, da imate redko, hudo nenadno alergijsko reakcijo (t.i. anafilaktično reakcijo).
Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for Helixate NexGen in laboratory animals (mouse, rat, rabbit, and dog). 
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 Helixate NexGen.
Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors. 
Potek zdravljenja teh bolnikov mora voditi zdravnik z izkušnjami v zdravljenju hemofilije in uporabe inhibitorjev faktorja VIII.
May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label. 
Zdravilo lahko do 12 mesecev shranjujete pri temperaturi do 25 °C do navedenega datuma izteka roka uporabnosti.
Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper. 
Vzemite Mix2Vial skupaj s pretisnim omotom in potisnite konico modrega adapterja naravnost navzdol skozi zamašek viale z vehiklom.
• one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal) 
• 1 vialo s praškom (10 ml viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko)
Helixate NexGen can be infused by continuous infusion. 
Helixate NexGen se lahko uporabi kot kontinuirana infuzija.
• one vial with solvent (6 ml clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal) 
• 1 vialo z vehiklom (6 ml viala iz prozornega stekla tipa 1 s sivim klorobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko)
Place the solvent vial on an even, clean surface and hold the vial tight. 
Postavite vialo z vehiklom na ravno, čisto površino in jo trdno primite.
The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU). 
Aktivnost zdravila (i.e.) se ugotavlja z enostopenjskim preizkusom strjevanja krvi, v primerjavi z FDA mega-standardom, ki je bil umerjen v mednarodnih enotah (i.e.) glede na standard SZO.
The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. 
Količine faktorja VIII, potrebne za zdravljenje, so izražene v mednarodnih enotah (i.e.), ki so določene s standardom SZO za faktor VIII.
• If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back. 
• Če je pri vas že kdaj prišlo do nastanka inhibitorjev faktorja VIII, obstaja pri zamenjavi enega zdravila s faktorjem VIII z drugim zdravilom s faktorjem VIII, tveganje za ponovni nastanek inhibitorjev.
The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions. 
Kompleks faktorja VIII in von Willebrandovega faktorja (vWF) je sestavljen iz dveh molekul
Systemic Hypersensitivit y reactions (including anaphylactic reaction, nausea, blood pressure abnormal and, dizziness) 
sistemske preobčutljivostn e reakcije (tudi anafilaksija, navzea, nenormalen krvni tlak in omotica)
Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma). 
(glede na normalno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor VIII v plazmi).
• hypersensitivity reactions including severe sudden allergic reaction (which may include hives, nausea, urticaria, angioedema, chills, flushing, headache, lethargy, wheezing or difficulty breathing, restlessness, tachycardia, tingling or anaphylactic shock, e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing) 
navzeo, koprivnico, angioedem, mrzlico, vročinski obliv, glavobol, letargijo, sopenje ali težave z dihanjem, nemir, tahikardijo, ščemenje ali anafilaktični šok, npr. tiščanje v prsnem košu/splošno slabo počutje, omotica, občutek siljenja na bruhanje in blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, kadar stojite) • zvišana telesna temperatura
For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml). 
Za izračun hitrosti infundiranja v ml/h se hitrost infundiranja i.e./h/kg pomnoži s kg telesne mase/koncentracija raztopine (i.e./ml).
The dose, frequency and duration of the substitution therapy must be individualised according to the patient's needs (weight, severity of disorder of the haemostatic function, the site and extent of the bleeding, the presence of inhibitors, and the factor VIII level desired). 
Odmerek, pogostnost in trajanje nadomestnega zdravljenja je treba prilagoditi potrebam posameznega bolnika (odvisno od telesne mase, stopnje motnje strjevanja krvi, mesta in obsega krvavitve, prisotnosti inhibitorjev in od želenega dviga aktivnosti faktorja VIII).
It is strongly recommended that every time that Helixate NexGen is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product. 
Priporočljivo je, da se po vsaki uporabi zdravila Helixate NexGen zabeležita ime in serijska številka zdravila, da je mogoča povezava med bolnikom in serijo zdravila, ki ga je prejel.
Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe. 
Sedaj ko je raztopina v brizgi, trdno primite brizgo (bat brizge naj gleda navzdol) in odstranite prozoren Mix2Vial adapter z brizge.
After reconstitution, the solution is drawn through the Mix2Vial filter transfer device into the sterile disposable syringe (both supplied). 
Po rekonstituciji raztopino filtrirajte skozi pribor za prenos vehikla Mix2Vial s filtrom v sterilno brizgo (igla in brizga sta priloženi).
After reconstitution, the product must be used within 3 hours. 
Zdravilo je treba po rekonstituciji uporabiti v 3 urah.
He/she should always adjust the amount of this medicine to be administered and the frequency of administration according to your individual needs. 
Zdravnik mora odmerek in pogostost dajanja odmerka tega zdravila prilagoditi glede na vaše individualne potrebe.
By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. 
S tem se začasno popravi pomanjkanje faktorja VIII in se zmanjša nagnjenost h krvavitvam.
The degree and duration of aPTT normalisation observed after administration of Helixate NexGen is similar to that achieved with plasma-derived factor VIII. 
Stopnja in trajanje normalizacije APTČ sta pri zdravilu Helixate NexGen podobna kot pri faktorju
• local reactions where you injected the medication (e.g. burning sensation, temporary redness) 
• lokalne reakcije na mestu injiciranja (npr. pekoča bolečina, prehodna rdečica)
Therefore, Helixate NexGen should be used during pregnancy and breast-feeding only if clearly indicated. 
Izkušenj o uporabi zdravila Helixate NexGen med nosečnostjo in dojenjem ni, zato ga med nosečnostjo in dojenjem uporabljamo le, če je to jasno indicirano.
1 vial with 5.0 ml water for injections. 
OVOJNINAH VIALA S 5,0 ML VODE ZA INJEKCIJE
Skin associated hypersensitivity reactions, (pruritus, urticaria and rash) 
Bolezni imunskega sistema preobčutljivos tne kožne reakcije (pruritus, urtikatija in osip)
Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII. 
Pri bolnikih s hemofilijo A lahko nastanejo nevtralizirajoča protitelesa (inhibitorji) proti faktorju VIII.
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. 
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.
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. 
se lahko vaš zdravnik odloči za dodatno zdravilo, koncentrat faktorja VIIa ali koncentrat (aktiviranega) protrombinskega kompleksa.
1 vial with 2.5 ml water for injections. 
OVOJNINAH VIALA S 2,5 ML VODE ZA INJEKCIJE
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". 
V in vitro študijah je bilo zdravilo v PVC vrečkah, pripravljeno za kontinuirano infuzijo, pri temperaturi 30 °C kemijsko in fizikalno stabilno 24 ur.
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. 
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.
Solvent: water for injection, a clear, colourless solution. 
Vehikel: voda za injekcije, bistra, brezbarvna raztopina Rekonstituirano zdravilo je bistra in brezbarvna raztopina.
Detailed instructions for preparation and administration are contained in the package leaflet provided with Helixate NexGen. 
Natančna navodila za pripravo in uporabo so v navodilu za uporabo ki je priložen zdravilu, Helixate
The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min). 
Hitrost injiciranja naj bo prilagojena počutju bolnika (največja hitrost injiciranja je 2 ml/min).
For major surgery in particular, close monitoring of the substitution therapy by means of coagulation analysis must be carried out. 
Predvsem pri večjih kirurških posegih je nujno potek nadomestnega zdravljenja skrbno spremljati z analizo strjevanja krvi.
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). 
se je pokazalo, da se zdravilo Helixate NexGen lahko uporablja kot kontinuirana infuzija pri kirurških posegih (pred, med in po posegu).
Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII. 
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.
Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. 
Vialo z zdravilom s prozornim adapterjem nežno obračajte dokler se prašek popolnoma ne raztopi.
Do not use solutions containing visible particles or that are cloudy. 
Ne uporabljajte raztopin z vidnimi delci ali motnih raztopin.
Puncture the vein and secure the venipuncture set with a plaster. 
Punktirajte veno in z obližem pritrdite pribor za punkcijo vene.
When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation. 
Po injiciranju faktorja VIII bolniku s hemofilijo se faktor VIII v krvnem obtoku veže na vWF.
Helixate NexGen has no influence on the ability to drive or to use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Helixate NexGen nima vpliva na sposobnost vožnje in upravljanja s stroji.
Discard the solvent vial with the blue Mix2Vial adapter attached. 
Vialo z vehiklom z modrim adapterjem Mix2Vial zavrzite.
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. 
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).
Animal reproduction studies have not been conducted with Helixate NexGen. 
Študij na živalih o vplivu zdravila Helixate NexGen na sposobnost razmnoževanja ni na voljo.
During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. 
V študijah niso pri nobenem od bolnikov opazili klinično pomembnih titrov protiteles proti beljakovinam miši in hrčkov, ki so v sledovih prisotne v zdravilu.
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. 
Če se uporabi drug pribor je lahko zdravljenje zaradi adsorpcije humanega rekombinantnega faktorja strjevanja krvi VIII na notranje stene nekaterih priborov za injiciranje neuspešno.
Expected factor VIII rise (% of normal) = 2 × administered IU body weight (kg) 
Pričakovani dvig aktivnosti faktorja VIII (% normalne vrednosti) = 2 × dani odmerek (i.e.)
• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. 
• Pri uporabi tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
Powder: dry white to slightly yellow powder or cake. 
Prašek: suh bel do rahlo rumen prašek ali pogača
During clinical studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. 
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.
In such cases, it is recommended that a specialised haemophilia centre be contacted. 
V takih primerih se priporoča posvetovanje z zdravstvenim osebjem, ki je specializirano za obravnavo hemofilije.
After reconstitution, the chemical and physical in-use stability has been demonstrated for 3 hours in in vitro studies. 
V in vitro študijah je bilo po rekonstituciji zdravilo kemijsko in fizikalno stabilno 3 ure.
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. 
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.
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. 
Laboratorijske preiskave Za doseganje in vzdrževanje ustrezne vrednosti faktorja VIII je priporočljivo, da se v rednih presledkih naredijo ustrezne laboratorijske preiskave plazme.
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 
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.
BATCH NUMBER Lot 
Luer Lock.
What Helixate NexGen 2000 IU is and what it is used for 
Kaj je zdravilo Helixate NexGen 2000 i.e. in za kaj ga uporabljamo
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). 
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).
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use, single dose administration only. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko uporabo, enkratni odmerek za injiciranje Pred uporabo preberite priloženo navodilo!
INFORMATION IN BRAILLE Helixate NexGen 2000 
PODATKI V BRAILLOVI PISAVI Helixate NexGen 2000
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. 
Za ugotavljanje primernega odmerka in pogostosti dajanja infuzij se med zdravljenjem svetuje redno določanje vrednosti faktorja VIII.
Infusion rate IU/h/kg 
telesna masa (kg)
If you want to stop using Helixate NexGen 1000 IU Do not stop using Helixate NexGen without consulting your doctor. 
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.
Do not use Helixate NexGen if you notice visible particulate matter or turbidity. 
Ne uporabite zdravila Helixate NexGen, če v raztopini opazite vidne delce ali je raztopina motna.
Allergic type hypersensitivity reactions are possible with Helixate NexGen. 
Preobčutljivost Po uporabi zdravila Helixate NexGen se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved. 
Zdravljenje naj traja vsaj 1 dan, dokler se krvavitev ne ustavi
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). 
MedDRA (uporabljen je najustreznejši izraz po klasifikaciji MedDRA).
If you are using Helixate NexGen to prevent bleeding (prophylaxis), your doctor will calculate the dose for you. 
Če zdravilo Helixate NexGen 1000 i.e. uporabljate za preprečevanje krvavitev (profilakso), bo velikost odmerka za vas izračunal zdravnik.
Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 1000 IU. 
Pribor za rekonstitucijo in aplikacijo je priložen v vsakem pakiranju zdravila Helixate NexGen 1000 i.e..
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. 
Za dolgotrajno preprečevanje krvavitev pri bolnikih s hudo hemofilijo A so običajni odmerki od 20 do
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 
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.
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). 
tahikardijo, tiščanje v prsnem košu, ščemenje, bruhanje, sopenje), ki lahko v nekaterih primerih napredujejo do hude anafilakse (tudi šok).
These therapies should be directed by physicians with experience in the care of patients with haemophilia. 
Zdravljenje mora potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo.
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. 
Prašek Helixate NexGen se lahko raztopi le v priloženem vehiklu (5,0 ml vode za injekcije).
Other medicines and Helixate NexGen 250 IU 
Druga zdravila in zdravilo Helixate NexGen 250 i.e.
INFORMATION IN BRAILLE Helixate NexGen 250 
PODATKI V BRAILLOVI PISAVI Helixate NexGen 250
Solvent: water for injections. 
Vehikel: voda za injekcije
Rare: may affect up to 1 in 1,000 users 
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
What Helixate NexGen 250 IU is and what it is used for 
Kaj je zdravilo Helixate NexGen 250 i.e. in za kaj ga uporabljamo
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. 
Vialo z vehiklom, na katero je pritrjen komplet Mix2Vial, obrnite in potisnite konico prozornega adapterja naravnost navzdol skozi zamašek viale z zdravilom.
If you forget to use Helixate NexGen 250 IU 
Če ste pozabili uporabiti zdravilo Helixate NexGen 250 i.e.
Other medicines and Helixate NexGen 2000 IU 
Druga zdravila in zdravilo Helixate NexGen 2000 i.e.
While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting. 
Medtem ko je viala z zdravilom v pokončnem položaju, pritrdite brizgo na Mix2Vial
INFORMATION IN BRAILLE Helixate NexGen 1000 
PODATKI V BRAILLOVI PISAVI Helixate NexGen 1000
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. 
Prašek Helixate NexGen se lahko raztopi le v priloženem vehiklu (2,5 ml vode za injekcije).
How to use Helixate NexGen 250 IU 
Kako uporabljati zdravilo Helixate NexGen 250 i.e.
No interactions of Helixate NexGen with other medicinal products have been reported. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O medsebojnem delovanju zdravila Helixate NexGen z drugimi zdravili ni poročil.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer Pharma AG
INFORMATION IN BRAILLE Helixate NexGen 500 
PODATKI V BRAILLOVI PISAVI Helixate NexGen 500
What is in this leaflet 
* glejte poglavje spodaj
What Helixate NexGen 1000 IU is and what it is used for 
Kaj je zdravilo Helixate NexGen 1000 i.e. in za kaj ga uporabljamo
Other medicines and Helixate NexGen 3000 IU 
Druga zdravila in zdravilo Helixate NexGen 3000 i.e.
• You must use aseptic conditions (meaning clean and germ free) during reconstitution and administration. 
• Rekonstitucija in uporaba zdravila morata potekati v aseptičnih pogojih (t.j.