FrancophonIA/ELRC3.0 huggingface dataset:
English: • Each 5 mg pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution.
Slovenian: • Ena 5-miligramska napolnjena brizga za peroralno dajanje vsebuje 5 mg midazolama (v obliki midazolamijevega klorida) v 1 ml raztopine.
English: Ulcer-healing medicinal products
Slovenian: Zdravila za zdravljenje razjed
English: Do not attach a needle to the syringe Step 1
Slovenian: Ne natikajte igle na brizgo.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 7.5 mg /1.5 ml
Slovenian: Plastična brizga za peroralno dajanje 7,5 mg/1,5 ml
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 10 mg /2 ml
Slovenian: Plastična brizga za peroralno dajanje 10 mg/2 ml
English: There are no other preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
Slovenian: Poleg podatkov, ki so že vključeni v druga poglavja povzetka glavnih značilnosti zdravila, ni drugih predkliničnih podatkov o varnosti, ki bi bila pomembna za zdravnika, ki zdravilo predpiše.
English: For children aged 3 months to less than 1 year For oromucosal use only.
Slovenian: Za otroke, stare od 3 mesecev do manj kot1 leto.
English: Uncommon side effects (may affect up to 1 in 100 people): • Rash, hives (lumpy rash), itchiness
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): • agitiranost, nemir, sovražnost, bes ali agresivnost, vznemirjenost, zmedenost, evforija
English: • If you see any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
English: Always give this medicine exactly as a doctor has told you.
Slovenian: Pri dajanju tega zdravila natančno upoštevajte navodila zdravnika.
English: 3 months to less than 1 year: 2.5 mg - yellow labelled packaging 1 year to less than 5 years: 5 mg - blue labelled packaging 5 years to less than 10 years: 7.5 mg - purple labelled packaging 10 years to less than 18 years: 10 mg - orange labelled packaging The dose is the full contents of one oral syringe.
Slovenian: 1 leto do manj kot 5 let: 5 mg - modro označeno pakiranje;
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 2.5 mg /0.5 ml
Slovenian: Plastična brizga za peroralno dajanje 2,5 mg/0,5 ml
English: Severe hepatic impairment
Slovenian: Težka jetrna okvara.
English: Co-administration with protease inhibitors (e.g. Saquinavir and other HIV protease inhibitors) may cause a large increase in the concentration of midazolam.
Slovenian: Zaviralci proteaze virusa HIV Sočasno dajanje z zaviralci proteaze (npr. s sakvinavirom in z drugimi zaviralci proteaze virusa HIV)
English: • some medicines used to treat HIV and AIDS, e.g. saquinavir, lopinavir/ritonavir combination
Slovenian: sakvinavir, kombinacija lopinavir/ritonavir,
English: Fentanyl may reduce midazolam clearance.
Slovenian: Anestetiki in narkotični analgetiki Fentanil lahko zmanjša očistek midazolama.
English: BUCCOLAM 2.5 mg oromucosal solution midazolam
Slovenian: BUCCOLAM 2,5 mg oralna raztopina midazolam
English: BUCCOLAM 2.5 mg oromucosal solution
Slovenian: BUCCOLAM 2,5 mg oralna raztopina
English: • Fits (convulsions)
Slovenian: Povprečje SD (standardna deviacija)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 5 mg /1 ml
Slovenian: Oznaka plastičnega zaščitnega ovitka 5 mg/1 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (2 ml) contains 10 mg midazolam (as hydrochloride)
Slovenian: Ena napolnjena brizga za peroralno dajanje (2 ml) vsebuje 10 mg midazolama (v obliki midazolamijevega klorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (1.5 ml) contains 7.5 mg midazolam (as hydrochloride)
Slovenian: Ena napolnjena brizga (1,5 ml) za peroralno dajanje vsebuje 7,5 ml midazolama (v obliki midazolamijevega klorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (0.5 ml) contains 2.5 mg midazolam (as hydrochloride)
Slovenian: Ena napolnjena brizga za peroralno dajanje (0,5 ml) vsebuje 2,5 mg midazolama (v obliki midazolamijevega klorida).
English: Each pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution BUCCOLAM 5 mg oromucosal solution
Slovenian: Ena napolnjena brizga za peroralno dajanje vsebuje 2,5 mg midazolama (v obliki midazolamijevega klorida) v 0,5 ml raztopine.
English: Gastrointestinal disorders
Slovenian: Volumen raztopine
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (1 ml) contains 5 mg midazolam (as hydrochloride)
Slovenian: Ena napolnjena brizga za peroralno dajanje (1 ml) vsebuje 5 mg midazolama (v obliki midazolamijevega klorida).
English: Constipation**, dry mouth**
Slovenian: Pogosti: navzea in bruhanje Zelo redki: zaprtost**, suha usta**
English: Each pre-filled oral syringe contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution BUCCOLAM 10 mg oromucosal solution
Slovenian: Ena napolnjena brizga za peroralno dajanje vsebuje 7,5 mg midazolama (v obliki midazolamijevega klorida) v 1,5 ml raztopine.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/709/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET: EU/1/11/709/002
English: Each pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution BUCCOLAM 7.5 mg oromucosal solution
Slovenian: Ena napolnjena brizga za peroralno dajanje vsebuje 5 mg midazolama (v obliki midazolamijevega klorida) v 1 ml raztopine.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/709/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET: EU/1/11/709/004
English: 2.5 mg 3 m < 1 yr
Slovenian: Plastična peroralna brizga 5 mg/1 ml
English: Strengths 5 mg, 7.5 mg and 10 mg:
Slovenian: Jakosti 5 mg, 7,5 mg in 10 mg Predpisovanje in izdaja zdravila je le na recept.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/709/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/709/001
English: Sleep apnoea syndrome
Slovenian: Sindrom spalne apneje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/709/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET: EU/1/11/709/003
English: • St John's Wort (a herbal medicine).
Slovenian: • šentjanževka (zeliščno zdravilo).
English: • Constipation
Slovenian: • utrujenost;
English: How long this lasts depends on how much BUCCOLAM was given..
Slovenian: • krči (konvulzije); • začasna izguba spomina Trajanje učinkov je odvisno od odmerka zdravila BUCCOLAM, ki ga je bolnik prejel;
English: Herbs
Slovenian: Zelišča
English: Wash your hands thoroughly using soap and warm water.
Slovenian: Roke se temeljito umijte z milom in toplo vodo.
English: EXP (End of the 12 month period, if stored at room temperature): ........... Do not use after this date.
Slovenian: EXP (konec 12 mesečnega obdobja, če se hrani pri sobni temperaturi): ............ Ne uporabljajte po tem datumu.
English: Do not increase your dose of medicine you use to control your bleeding without consulting your doctor.
Slovenian: Ne povečajte odmerka tega zdravila, ki ga uporabljate za nadzor krvavitev, ne da bi se posvetovali z zdravnikom.
English: Frequencies have been evaluated according to the following convention: very common: (1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: How much Helixate NexGen you should use and how often you should use it depends on many factors such as:
Slovenian: Koliko zdravila Helixate NexGen morate uporabiti in kako pogosto je odvisno od več dejavnikov, kot so:
English: Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).
Slovenian: Z rokami ogrejte obe neodprti viali na primerno temperaturo (ne več kot 37 °C).
English: Make sure that no blood enters the syringe.
Slovenian: Zagotovite, da kri ne teče v injekcijsko brizgo.
English: The specific activity of Helixate NexGen is approximately 4000 IU/mg protein.
Slovenian: Specifična aktivnost zdravila Helixate NexGen je približno 4000 i.e./mg beljakovine.
English: Determine the point of injection and clean the skin with an alcohol swab.
Slovenian: Določite mesto injiciranja in kožo očistite z alkoholnim tamponom..
English: Novimed Ltd. Teл.
Slovenian: Novimed Ltd.
English: Helixate NexGen should be injected intravenously over 2 to 5 minutes.
Slovenian: Zdravilo Helixate NexGen je treba injicirati intravensko 2 do 5 minut.
English: Draw air into an empty, sterile syringe.
Slovenian: Potegnite zrak v prazno sterilno injekcijsko brizgo.
English: Helixate NexGen has no influence on the ability to drive or to use machines.
Slovenian: Zdravilo Helixate NexGen nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Continuous infusion
Slovenian: Kontinuirana infuzija
English: The speed of injection should be based on your comfort, but should not be faster than 2.0 mL per minute.
Slovenian: Hitrost injiciranja naj bo prilagojena vašemu počutju, vendar ne injicirajte hitreje kot 2 ml na minuto).
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity.
Slovenian: Izračun potrebnega odmerka faktorja VIII temelji na empirični ugotovitvi, da ena mednarodna enota (i.e.) faktorja VIII na kilogram telesne mase poveča aktivnost faktorja VIII v plazmi za 1,5 - 2,5 % normalne aktivnosti.
English: EU/1/00/144/001 - Helixate NexGen 250 IU EU/1/00/144/002 - Helixate NexGen 500 IU EU/1/00/144/003 - Helixate NexGen 1000 IU EU/1/00/144/004 - Helixate NexGen 2000 IU EU/1/00/144/005 - Helixate NexGen 3000 IU
Slovenian: EU/1/00/144/001 - Helixate NexGen 250 i.e. EU/1/00/144/002 - Helixate NexGen 500 i.e. EU/1/00/144/003 - Helixate NexGen 1000 i.e. EU/1/00/144/004 - Helixate NexGen 2000 i.e. EU/1/00/144/005 - Helixate NexGen 3000 i.e.
English: Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution.
Slovenian: Pustite, da kri teče nazaj k odprtemu koncu pribora za vensko punkcijo in nato pritrdite injekcijsko brizgo z raztopino.
English: • an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
Slovenian: • dodatno pakiranje, ki vsebuje: - 1 pribor za prenos filtra 20/20 (Mix2Vial) - 1 pribor za vensko punkcijo - 1 injekcijsko brizgo po 5 ml za enkratno uporabo - dva alkoholna tampona za enkratno uporabo
English: Take special care with Helixate NexGen and talk to your doctor or pharmacist if:
Slovenian: Opozorila in previdnostni ukrepi Bodite posebno pozorni pri uporabi zdravila Helixate NexGen in se posvetujte z zdravnikom ali farmacevtom, če:
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients
Slovenian: * Pogostnost temelji na študijah z vsemi zdravili s FVIII, ki so vključevale bolnike s hudo hemofilijo A. PZB = predhodno zdravljeni bolniki, PNB = predhodno nezdravljeni bolniki
English: What Helixate NexGen is and what it is used for What you need to know before you use Helixate NexGen How to use Helixate NexGen Possible side effects
Slovenian: Kaj je zdravilo Helixate NexGen in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen Kako uporabljati zdravilo Helixate NexGen Možni neželeni učinki
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Slovenian: Za navodila,glede rekonstitucije zdravila pred uporabo glejte poglavje 6.6 in navodilo za uporabo.
English: If you are using Helixate NexGen to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Slovenian: Če zdravilo Helixate NexGen uporabljate za preprečevanje krvavitev (profilakso), bo velikost odmerka za vas izračunal zdravnik.
English: Use in children and adolescents Helixate NexGen can be used in children of all ages.
Slovenian: Uporaba pri otrocih in mladostnikih Zdravilo Helixate NexGen se lahko uporablja pri otrocih vseh starosti.
English: Treatment of bleeding Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
Slovenian: Zdravljenje krvavitve Zdravnik bo izračunal velikost in pogostost dajanja odmerka tega zdravila, ki ga potrebujete, da se pri vas doseže želena raven faktorja VIII v krvi.
English: The degree and duration of aPTT normalisation observed after administration of Helixate NexGen is similar to that achieved with plasma-derived factor VIII.
Slovenian: Stopnja in trajanje normalizacije APTČ sta po uporabi zdravila Helixate NexGen podobna kot pri faktorju VIII, pridobljenim iz plazme.
English: If you want to stop using Helixate NexGen Do not stop using Helixate NexGen without consulting your doctor.
Slovenian: Če želite prenehati uporabljati zdravilo Helixate NexGen Ne prenehajte uporabljati zdravila Helixate NexGen, ne da bi se prej posvetovali z zdravnikom.
English: If this happens, you should contact your doctor immediately.
Slovenian: Če pride do tega, takoj pokličite zdravnika.«
English: Helixate NexGen is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Slovenian: Ni verjetno, da bi zdravilo Helixate NexGen vplivalo na plodnost bolnikov ali bolnic, saj je zdravilna učinkovina v telesu naravno prisotna.
English: Experience regarding fertility or the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Slovenian: Izkušenj glede plodnosti ali uporabi zdravila Helixate NexGen med nosečnostjo in dojenjem ni.
English: Table 1: Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/
Slovenian: Preglednica 1: Smernice za odmerjanje pri krvavitvah in kirurških posegih
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 40 i.e. zdravila Helixate NexGen na kg telesne mase vsake 2 do 3 dni.
English: Each vial of Helixate NexGen contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Slovenian: Ena viala zdravila Helixate NexGen vsebuje nominalno 250, 500, 1000, 2000 ali 3000 i.e. oktokoga alfa.
English: If your or your child's bleeding is not being controlled with Helixate NexGen, tell your doctor immediately.
Slovenian: Če krvavitev pri vas ali vašem otroku z zdravilom Helixate NexGen ni obvladana, morate to nemudoma povedati zdravniku.
English: After administration of Helixate NexGen, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Slovenian: Po uporabi zdravila Helixate NexGen se maksimalna aktivnost faktorja VIII zmanjšuje dvofazno eksponentno, razpolovni čas je približno 15 ur.
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: V klinični študiji pri odraslih bolnikih s hemofilijo A, pri katerih je bil opravljen večji kirurški poseg, se je pokazalo, da se zdravilo Helixate NexGen lahko uporablja kot kontinuirana infuzija pri kirurških posegih (pred, med in po posegu).
English: 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.
Slovenian: Zdravilo Helixate NexGen kot pomožno snov vsebuje majhno količino polisorbata 80, za katerega je znano, da poveča hitrost ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih (PVC) materialov.
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Slovenian: Previdno odstranite pretisni omot iz kompleta Mix2Vial tako, da držite obroč, in potegnite navpično navzgor.
English: Ensure product and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial package.
Slovenian: Preverite, da sta zamaška viale z zdravilom in viale z vehiklom odstranjena in da sta zaporki obrisani z aseptično raztopino in pustite, da se pred odprtjem pakiranja Mix2Vial posuši.
English: This medicine is intended for injection into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after preparing the solution.
Slovenian: To zdravilo je namenjeno za injiciranje v veno, 2 do 5 minut, kar je odvisno od skupne količine in vašega počutja.
English: Do not use solutions containing visible particles or that are cloudy.
Slovenian: Ne uporabljajte raztopine, ki vsebuje vidne delce ali je motna.
English: What Helixate NexGen is and what it is used for
Slovenian: Kaj je zdravilo Helixate NexGen in za kaj ga uporabljamo
English: If you have used more Helixate NexGen than you should, please inform your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila Helixate NexGen, kot bi smeli, o tem obvestite zdravnika.
English: If you use more Helixate NexGen than you should No cases of overdose with recombinant coagulation factor VIII have been reported.
Slovenian: Če ste uporabili večji odmerek zdravila Helixate NexGen, kot bi smeli Ni poročil o prevelikem odmerjanju rekombinantnega koagulacijskega faktorja VIII.
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per mL, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with Helixate NexGen.
Slovenian: Če je raven zaviralca manjša kot 10 Bethesda enot (BE) na mililiter, ga je možno nevtralizirati z dodatnim rekombinantnim koagulacijskim faktorjem VIII in nadaljevati klinično učinkovito zdravljenje z zdravilom Helixate NexGen.
English: Helixate NexGen can be infused by continuous infusion.
Slovenian: Zdravilo Helixate NexGen se lahko uporabi kot kontinuirana infuzija.
English: Usually, the substitution therapy with Helixate NexGen is a life-time treatment.
Slovenian: Običajno je nadomestno zdravljenje z zdravilom Helixate NexGen potrebno celo življenje.
English: 1 vial with 2.5 mL water for injections.
Slovenian: VIALA S 2,5 ML ali 5 ML VODE ZA INJEKCIJE
English: Each package of Helixate NexGen contains:
Slovenian: Eno pakiranje zdravila Helixate NexGen vsebuje:
English: No interactions of Helixate NexGen with other medicinal products have been reported.
Slovenian: O medsebojnem delovanju zdravila Helixate NexGen z drugimi zdravili ni poročil.
English: What you need to know before you use Helixate NexGen
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Helixate NexGen
English: Hold the syringe upright and push the plunger until no air is left in the syringe.
Slovenian: Injekcijsko brizgo držite pokončno in potiskajte bat toliko časa, da v injekcijski brizgi ne bo več zraka.
English: It is recommended that every time that you use Helixate NexGen, the name and batch number of the product are documented.
Slovenian: Priporočljivo je, da po vsaki uporabi zdravila Helixate NexGen zabeležite ime zdravila in številko serije.
English: • you require a central venous access device (CVAD) for the administration of Helixate NexGen.
Slovenian: • je pri vas za vnos zdravila Helixate NexGen potreben centralni venski kateter (CVK).
English: 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.
Slovenian: Priporočljivo je, da se po vsaki uporabi zdravila Helixate NexGen zabeležita ime zdravila in številka serije, da je mogoča sledljivost med bolnikom in serijo zdravila.
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 ml viala iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko)
English: The PRAC considered that as a prospective randomised trial, the SIPPET study avoided many of the design limitations of the observational and registry-based studies undertaken so far to evaluate the risk of inhibitor development in PUPs.
Slovenian: Odbor PRAC je menil, da študija SIPPET kot prospektivno randomizirano preskušanje nima številnih omejitev zasnove opazovalnih in registrskih študij, ki so bile izvedene do sedaj, da bi ocenile
English: • one vial with solvent (6 mL clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
Slovenian: • 1 vialo z vehiklom (6 ml viala iz prozornega stekla tipa 1 s sivim klorobutilnim gumijastim zamaškom brez lateksa in aluminijasto zaporko)
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with Helixate NexGen.
Slovenian: Podrobnejša navodila za pripravo in uporabo so v navodilu za uporabo ki je priloženo zdravilu Helixate NexGen.
English: Therefore, Helixate NexGen should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Izkušenj o uporabi zdravila Helixate NexGen med nosečnostjo in dojenjem ni, zato se ga med nosečnostjo in dojenjem sme uporabljati le, če je to jasno indicirano.
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 Helixate NexGen in laboratory animals (mouse, rat, rabbit, and dog).
Slovenian: Tudi pri uporabi 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.
English: Other medicines and Helixate NexGen
Slovenian: Druga zdravila in zdravilo Helixate NexGen
English: How to store Helixate NexGen Contents of the pack and other information
Slovenian: Shranjevanje zdravila Helixate NexGen Vsebina pakiranja in dodatne informacije
English: Helixate NexGencontains the active substance human recombinant coagulation factor VIII (octocog alfa).
Slovenian: Zdravilo Helixate NexGen vsebuje zdravilno učinkovino humani rekombinantni koagulacijski faktor VIII (oktokog alfa).
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 za kontinuirano infuzijo, pri temperaturi 30 °C kemijsko in fizikalno stabilno 24 ur.
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 ni pri nobenem od bolnikov nastal klinično pomemben titer protiteles proti beljakovinam miši in hrčkov, ki so v sledovih prisotne v zdravilu.
English: After reconstitution, the solution is drawn through the Mix2Vial filter transfer device into the sterile disposable syringe (both supplied).
Slovenian: Po rekonstituciji raztopino filtrirajte skozi pribor za prenos vehikla Mix2Vial s filtrom v sterilno injekcijsko brizgo (igla in injekcijska brizga sta priloženi)..