natgillin/translations-raw huggingface dataset:
Safely dispose of the syringe, vials, any unused product and other waste materials as instructed by your healthcare professional.
Varno zavrzite brizgo, obe viali, morebitno neuporabljeno zdravilo in ostali odpadni material, tako kot vas je o tem poučilo vaše zdravstveno osebje.
Healthy subjects
Zdravi preiskovanci
This results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor.
Posledica je pretvorba protrombina v veliko količino trombina,
• If you have Factor VII deficiency
Če imate pomanjkanje faktorja VII:
There are no studies on the effect of NovoSeven on the ability to drive and use machines.
Študij o vplivu zdravila NovoSeven na sposobnost upravljanja vozil in strojev niso izvedli.
Do not use the reconstituted solution if you notice particles in it or if it is discoloured.
Pripravljene raztopine ne uporabite, če se v njej pojavijo delci ali če opazite, da je obarvana.
It is recommended to use NovoSeven immediately after reconstitution.
Zdravilo NovoSeven je priporočljivo uporabiti takoj po pripravi.
Instructions on how to use NovoSeven READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOSEVEN
Navodila za uporabo zdravila NovoSeven PRED UPORABO ZDRAVILA NOVOSEVEN NATANČNO PREBERITE TA NAVODILA
There is no clinical experience with administration of a single dose of 270 µg per kg body weight in elderly patients.
Pri starejših bolnikih ni kliničnih izkušenj z uporabo posamičnega odmerka 270 µg na kilogram telesne mase.
The usual dose is 90 micrograms (range is 80 to 120 micrograms) for every 1 kilogram you weigh, for each injection.
Običajni odmerek za vsako injekcijo je 90 mikrogramov (razpon od 80 do 120 mikrogramov) na vsak kilogram telesne mase.
Remove the protective paper from the vial adapter without taking it out of the protective cap.
Odstranite zaščitni papir z nastavka za vialo, brez da bi ga vzeli iz zaščitnega pokrovčka.
Pre-filled syringe: Type I glass barrel with a polypropylene backstop and bromobutyl rubber plunger.
Napolnjena injekcijska brizga: telo iz stekla tipa I s polipropilensko vzvratno zaporo in batom iz bromobutilne gume.
The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or the surgery being performed.
Trajanje zdravljenja in interval med injekcijami se razlikuje glede na to, kako huda je krvavitev, invazivni postopek ali operacija.
Take care not to touch the end of the transfer needle.
Pazite, da se ne boste dotaknili konice igle.
• If you were born with haemophilia and do not respond normally to factors VIII or IX treatment
• prirojeno hemofilijo in se ne odzivajo normalno na zdravljenje s faktorjem VIII ali IX,
• Lightly squeeze the protective cap with your thumb and index finger as shown.
• S palcem in kazalcem rahlo stisnite zaščitni pokrovček, kot je prikazano.
Administration through a needleless connector may require withdrawal of the reconstituted solution into a standard 10 ml sterile luer-lock plastic syringe.
Za aplikacijo zdravila skozi brezigelne konektorje bo morda potrebno izvleči pripravljeno raztopino v standardno 10-ml sterilno plastično brizgo, ki ima nastavek luer.
Signs may include skin rashes, itching, flushing and hives; wheezing or difficulty breathing; feeling faint or dizzy; and severe swelling of the lips or throat, or at the injection site.
Med znaki so lahko izpuščaj na koži, srbečica, vročinski oblivi in koprivnica, piskajoče ali težko dihanje, omotica ali omedlevica in huda oteklost ustnic ali žrela ali oteklost na mestu injiciranja.
• If you have Glanzmann's thrombasthenia (a bleeding disorder) and your condition cannot be treated effectively with platelet transfusion, or if platelets are not readily available.
• Glanzmannovo trombastenijo (motnjo strjevanja krvi), ki je ni mogoče učinkovito zdraviti s transfuzijo trombocitov, ali če trombociti niso takoj na voljo.
As recombinant coagulation factor VIIa NovoSeven may contain trace amounts of mouse IgG, bovine IgG and other residual culture proteins (hamster and bovine serum proteins), the remote possibility exists that patients treated with the product may develop hypersensitivity to these proteins.
IgG in drugih rezidualnih beljakovin kulture (hrčkove in goveje serumske beljakovine), zato obstaja pri bolnikih, ki dobivajo to zdravilo, neznatna možnost za pojav preobčutljivosti na te beljakovine.
Following the initial dose of NovoSeven further injections may be given if required.
Če je potrebno, je mogoče po začetnem odmerku zdravila NovoSeven dati še dodatne injekcije.
Table 1 lists adverse reactions reported during clinical trials and from spontaneous (post-marketing) reports.
V preglednici 1 je prikazan seznam neželenih učinkov, ki so bili ugotovljeni v kliničnih preskušanjih in tistih, ki so bili spontano poročani po začetku trženja.
The NovoSeven powder must be reconstituted with its solvent and injected into a vein.
Prašek NovoSeven je treba zmešati s topilom in injicirati v veno.
If you cannot use it immediately, after it has been mixed, you should store it in the vial with the vial adapter and syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours.
Če ga ne morete uporabiti takoj po pripravi, ga morate shraniti v viali (nastavek za vialo in brizga morata ostati nameščena) v hladilniku pri temperaturi od 2 do 8 °C, vendar ne več kot 24 ur.
Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Topilo histidin klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
Your doctor may recommend a single dose of 270 micrograms for every 1 kilogram you weigh.
Zdravnik vam lahko svetuje posamičen odmerek 270 mikrogramov na vsak kilogram telesne mase.
Do not touch the syringe tip under the syringe cap.
Ne dotikajte se konice injekcijske brizge pod pokrovčkom injekcijske brizge.
Only after consultation with the haemophilia treatment centre can continued home treatment be considered.
Nadaljnje zdravljenje na domu pride v poštev šele po posvetu s centrom za zdravljenje hemofilije.
Table 1 Adverse reactions from clinical trials and spontaneous (post-marketing) reports
Preglednica 1 Neželeni učinki iz kliničnih preskušanj in neželeni učinki, spontano poročani po začetku trženja
There is no requirement for monitoring of NovoSeven therapy.
Zdravljenja z zdravilom NovoSeven ni treba nadzirati.
Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to dry for a few seconds before use.
Gumijasti zamašek viale obrišite s sterilnim alkoholnim zložencem in pustite nekaj sekund, da se posuši, preden vialo uporabite.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Način uporabe Za navodila o pripravi raztopine pred uporabo glejte poglavje 6.6.
• 1 vial with white powder for solution for injection
• 1 vialo z belim praškom za raztopino za injiciranje,
Data on a limited number of exposed pregnancies within approved indications indicate no adverse effects of rFVIIa on pregnancy or on the health of the foetus/new-born child. To date, no other relevant epidemiological data are available.
Podatki, zbrani pri omejenem številu nosečnic, ki so bile izpostavljene zdravilu pri odobrenih indikacijah, ne kažejo neželenih učinkov rFVIIa na nosečnost ali zdravje ploda/novorojenca.
In vial
V viali
Injecting NovoSeven with pre-filled syringe via needleless connectors for intravenous (IV) catheters
Injiciranje zdravila NovoSeven z napolnjeno injekcijsko brizgo in brezigelnimi konektorji za intravenske (i.v.)
Powder and solvent for solution for injection.
prašek in topilo za raztopino za injiciranje
NovoSeven must not be mixed with infusion solutions or be given in a drip.
Zdravila NovoSeven se ne sme mešati z raztopinami za infundiranje ali dajati v kapalni infuziji.
The reconstituted solution has a pH of approximately 6.0.
Pripravljena raztopina ima pH približno
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, histidine, water for injections
natrijev klorid, kalcijev klorid dihidrat, glicilglicin, polisorbat 80, manitol, saharoza, metionin, histidin in voda za injekcije.
• Store powder and solvent protected from light.
• Prašek in topilo shranjujte zaščiteno pred svetlobo.
Check the solution for visible particles and discolouration.
Preglejte, da raztopina ne vsebuje vidnih delcev in ni obarvana.
• Nausea (feeling sick)
• siljenje na bruhanje (slabost v želodcu)
Signs may include difficulty in breathing, red and painful swelling in the leg and abdominal pain.
Med znaki so lahko težko dihanje, pordela in boleča oteklost noge ter bolečine v trebuhu.
The ingredients in the solvent are histidine, hydrochloric acid, sodium hydroxide, water for injections.
Topilo vsebuje histidin, klorovodikovo kislino, natrijev hidroksid in vodo za injekcije.
Each pack contains: 1 vial of powder 1 vial of solvent
Vsako pakiranje vsebuje: 1 vialo s praškom, 1 vialo s topilom.
site, pulmonary embolism, thromboembolic events of the liver
pljučna embolija, trombembolični dogodki v jetrih,
Haemophilia A and B with inhibitors
Hemofilija A ali B z zaviralci
If you use a vial adapter, tip the syringe to remove it from the vial.
Če uporabljate nastavek za vialo, zasučite brizgo, da ga boste odstranili z viale.
- Store powder and solvent protected from light.
- Prašek in topilo shranjujte zaščiteno pred svetlobo.
• Take the vial, the vial adapter and the pre-filled syringe out of the carton.
• Vzemite vialo, nastavek za vialo in napolnjeno injekcijsko brizgo iz škatle.
Store protected from light
Shranjujte zaščiteno pred svetlobo.
• While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
• Medtem ko držite vialo obrnjeno na glavo, previdno potrkajte po brizgi, da se bodo morebitni zračni mehurčki dvignili na vrh.
Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Nehajte potiskati nosilec bata in pustite, da se sam od sebe pomika nazaj, medtem ko pripravljena raztopina polni brizgo.
• Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the syringe).
• Preden obrnete brizgo na glavo, poskrbite, da bo bat potisnjen do konca (morda ga je pritisk v brizgi nekoliko iztisnil).
• in patients with congenital haemophilia with inhibitors to coagulation factors VIII or
• pri bolnikih s prirojeno hemofilijo z zaviralci koagulacijskih faktorjev VIII ali IX >
Safely dispose of the syringe, vials and any unused product.
Varno zavrzite brizgo, obe viali in morebitno neuporabljeno zdravilo.
How to use NovoSeven
Kako uporabljati zdravilo NovoSeven
Prepare the vial and the syringe
Pripravite vialo in injekcijsko brizgo
It works by making the blood clot at the site of bleeding, when the body's own clotting factors are not working.
Učinkuje tako, da v primeru, ko bolnikovi lastni faktorji strjevanja ne delujejo, naredi strdek na mestu krvavitve.
• NovoSeven is now ready for injection.
• Zdravilo NovoSeven je zdaj pripravljeno za injiciranje.
Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the syringe).
Preden obrnete brizgo na glavo, poskrbite, da bo bat potisnjen do konca (morda ga je pritisk v brizgi nekoliko iztisnil).
If you notice visible particles or discolouration, do not use it. Use a new package instead.
Če opazite vidne delce ali obarvanost, je ne uporabite.
• Remove the syringe cap from the pre-filled syringe by bending it down until the perforation breaks.
• Odstranite pokrovček injekcijske brizge z napolnjene injekcijske brizge, tako da ga upognete navzdol, dokler se perforacija ne prelomi.
The expiry date is printed after ‘EXP' on the outer carton, on the vial, on the vial adapter and on the pre-filled syringe.
Datum izteka roka uporabnosti je natisnjen na škatli, viali, nastavku za vialo in na napolnjeni injekcijski brizgi poleg oznake “Uporabno do”.
Patients with acquired haemophilia
Bolniki s pridobljeno hemofilijo
• Remove the plastic cap from the vial.
• Odstranite plastični pokrovček z viale.
NovoSeven should be given as early as possible after the start of a bleeding episode.
Zdravilo NovoSeven je treba dati čim prej po začetku krvavitve.
Overleaf: Instructions on how to use NovoSeven
Na drugi strani lista: Navodila za uporabo zdravila NovoSeven
When NovoSeven is administered to patients outside approved indications, arterial thromboembolic events are common (≥ 1/100 to < 1/10).
Trombembolični dogodki - arterijski in venski Če je zdravilo NovoSeven uporabljeno pri bolnikih zunaj odobrenih indikacij, so arterijski trombembolični dogodki pogosti (≥ 1/100 do < 1/10).
The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or surgery being performed.
Trajanje zdravljenja in presledek med injekcijami se razlikujeta glede na izrazitost krvavitve oz. potrebne invazivne postopke ali operacijo.
Push the plunger rod slowly until all air bubbles are gone.
Nosilec bata počasi potiskajte, dokler vsi zračni mehurčki ne izginejo.
The risk of a potential interaction between NovoSeven and coagulation factor concentrates is unknown.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Tveganje za možne interakcije med zdravilom NovoSeven in koncentrati koagulacijskih faktorjev ni znano.
Solvent: clear colourless solution.
Topilo: bistra, brezbarvna raztopina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton text
PODATKI NA ZUNANJI OVOJNINI Besedilo na škatli
Plastic cap Rubber stopper
Pregled plastični pokrovček gumijasti zamašek
For single dose injection
Za injiciranje v enkratnem odmerku.
Do not use the equipment without proper training from your doctor or nurse.
Ne uporabljajte opreme, dokler vas vaš zdravnik ali medicinska sestra tega ne naučita ustrezno.
If continued therapy is needed, the dose interval can be increased successively once effective haemostasis is achieved to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated.
Če je treba zdravljenje nadaljevati, je mogoče potem, ko je dosežena učinkovita hemostaza, odmerni interval postopoma podaljševati na 4, 6, 8 ali 12 ur, dokler je zdravljenje indicirano.
Push the plunger rod gently to inject a little air into the vial.
Previdno potisnite bat, da boste v vialo injicirali malo zraka.
The solvent of NovoSeven is provided in either a vial or in a pre-filled syringe.
Topilo za zdravilo NovoSeven je na voljo v viali ali v napolnjeni injekcijski brizgi.
Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Nosilec bata držite pritisnjen dol in previdno vrtite vialo, dokler se ves prašek ne raztopi.
Once haemostasis has been achieved, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged to be indicated.
Ko je dosežena hemostaza, je mogoče odmerni interval postopno podaljševati na vsake 4, 6, 8 ali 12 ur za toliko časa, kot je indicirano zdravljenje.
NovoSeven reconstituted product is a clear, colourless solution.
Pripravljena raztopina NovoSeven je bistra in brezbarvna.
The solvent is a histidine solution.
Topilo je raztopina s histidinom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve: 23. februar 1996
Thereafter, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated.
Potem je mogoče odmerni interval postopoma podaljševati na 4, 6, 8 ali 12 ur, dokler je zdravljenje indicirano.
NovoSeven is now ready for injection.
NovoSeven je tako pripravljen za injiciranje.
- 1 vial (12 ml) with white powder for solution for injection - 1 pre-filled syringe (10 ml) with solvent for reconstitution - 1 plunger rod - 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.
- 1 vialo (12 ml) z belim praškom za raztopino za injiciranje, - 1 napolnjeno injekcijsko brizgo (10 ml) s topilom za pripravo raztopine, - 1 nosilec bata, - 1 nastavek za vialo z integriranim filtrom za delce z velikostjo por 25 mikrometrov.
Remove the empty solvent vial.
Odstranite prazno vialo s topilom.
The powder vial contains white powder and the pre-filled syringe contains a clear colourless solution.
Viala s praškom vsebuje bel prašek, napolnjena injekcijska brizga pa bistro in brezbarvno raztopino.
• in patients with acquired haemophilia
• pri bolnikih s pridobljeno hemofilijo,
- Store powder and solvent below 25°C.
- Prašek in topilo shranjujte pri temperaturi do 25 °C.
• Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (ml equals cc on the syringe).
• Potegnite bat nazaj, tako da potegnete v brizgo natanko toliko zraka, kolikor je topila v viali s topilom (mililitri ustrezajo oznaki cc na brizgi).
Please refer to outer packaging for present pack size.
Za velikost tega pakiranja glejte zunanjo ovojnino.
When you prepare and inject medication directly into the vein, it is important to use a clean and germ free (aseptic) technique.
Pomembno je, da med pripravo in injiciranjem zdravila v veno uporabljate čist postopek brez klic (aseptičen postopek).
Dose limiting toxicities of NovoSeven have not been investigated in clinical trials.
V kliničnih preskušanjih niso raziskali toksičnih učinkov, ki omejujejo odmerek zdravila NovoSeven.
Remove the plastic caps from the two vials.
Odstranite plastična pokrovčka z obeh vial.
NovoSeven is a blood coagulation factor.
Kaj je zdravilo NovoSeven in za kaj ga uporabljamo Zdravilo NovoSeven je krvni koagulacijski faktor.
You should talk to your doctor before using NovoSeven if you also use Factor VIII or IX products.
Če uporabljate zdravila, ki vsebujejo faktor VIII ali IX, se posvetujte s svojim zdravnikom, preden uporabite zdravilo NovoSeven.
As the total number of treatment episodes in clinical trials is below 10,000, the lowest possible frequency of adverse drug reactions that can be assigned is rare (> 1/10,000 to < 1/1,000).
10.000 epizod zdravljenja, je "redko" (≥ 1/10.000 do < 1/1.000) najmanjša pogostnost, ki jo lahko določimo.
- Venous thromboembolic events (deep vein thrombosis, thrombosis at i.v.
- venski trombembolični dogodki (globoka venska tromboza, tromboza na mestu intravenske aplikacije,
In addition, the development of antibodies against NovoSeven and FVII has been associated with overdose in one patient with factor VII deficiency.
Poleg tega je bilo preveliko odmerjanje pri enem bolniku s pomanjkanjem faktorja VII povezano s pojavom protiteles proti zdravilu NovoSeven in FVII.
A higher risk of arterial thromboembolic adverse events (see table: Vascular disorders) (5.6% in patients treated with NovoSeven versus 3.0% in placebo-treated patients) has been shown in a meta-analysis of pooled data from placebo-controlled trials conducted outside current approved indications in various clinical settings, each of these having distinct patient characteristics and hence different underlying risk profiles.
Opravljena je bila metaanaliza kumulativnih podatkov s placebom kontroliranih preskušanj, opravljenih zunaj trenutno odobrenih indikacij v različnih kliničnih okoliščinah, od katerih ima vsaka posebne značilnosti bolnikov in s tem različne osnovne profile tveganja.
In post-marketing experience, there have been no reports of inhibitory antibodies against NovoSeven or FVII in patients with haemophilia A or B. Development of inhibitory antibodies to NovoSeven has been reported in a post-marketing observational registry of patients with congenital FVII deficiency.
Izkušnje po prihodu zdravila na trg kažejo, da pri bolnikih s hemofilijo A ali B ni poročil o zaviralnih protitelesih proti zdravilu NovoSeven ali FVII.
• Take out the number of NovoSeven packages you need.
• Vzemite toliko pakiranj zdravila NovoSeven,
• Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
• Nehajte potiskati nosilec bata in pustite, da se sam od sebe pomika nazaj, medtem ko pripravljena raztopina polni injekcijsko brizgo.
The NovoSeven reconstituted solution is colourless and should be inspected visually for particulate matter and discolouration prior to administration.
Pripravljena raztopina zdravila NovoSeven je brezbarvna in jo je treba pred uporabo pregledati, da ne vsebuje delcev in da ni obarvana.
• Store powder and solvent below 25°C.
• Prašek in topilo shranjujte pri temperaturi do 25 °C.
• The NovoSeven powder vial and pre-filled syringe with solvent should be at room temperature at reconstitution.
• Viala s praškom NovoSeven in napolnjena injekcijska brizga s topilom morata imeti ob pripravi sobno temperaturo.
If the protective paper is not fully sealed or it is broken do not use the vial adapter.
Če zaščitni papir ni povsem prilepljen ali je pretrgan, nastavka za vialo ne uporabite.
If you have Factor VII deficiency: The usual dose range is 15 to 30 micrograms for every 1 kilogram you weigh, for each injection.
Običajni odmerek za vsako injekcijo je 15 do 30 mikrogramov na vsak kilogram telesne mase.
Do not store the solution without advice from your doctor or nurse.
Raztopine ne shranjujte brez posveta z zdravnikom ali medicinsko sestro.
Powder in vial and solvent in pre-filled syringe:
Prašek v viali in topilo v napolnjeni injekcijski brizgi
Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe.
Držite brizgo in vialo skupaj obrnjeni na glavo in potegnite bat, tako da boste potegnili vso raztopino v brizgo.
Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (ml equals cc on the syringe).
Potegnite bat nazaj, tako da potegnete v brizgo natanko toliko zraka, kolikor je topila v viali s topilom (mililitri ustrezajo oznaki cc na brizgi).
- Intracardiac thrombus including portal vein thrombosis, renal vein thrombosis, thrombophlebitis, superficial thrombophlebitis and intestinal ischaemia)
tromboza ledvične vene, tromboflebitis, površinski tromboflebitis in ishemija črevesa)
No studies on the effect on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
• Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
• Nosilec bata držite pritisnjen do konca in previdno vrtite vialo, dokler se ves prašek ne raztopi.
Severity of bleeding condition and clinical response to NovoSeven administration must guide dosing requirements.
Odmerjanje je potrebno uravnavati glede na resnosti krvavitve in kliničnem odzivu na zdravilo NovoSeven.
An initial dose of 90 µg per kg body weight should be given immediately before the intervention.
Tik pred posegom je treba dati začetni odmerek 90 µg na kg telesne mase.
Thrombosis has been reported in FVII deficient patients receiving NovoSeven during surgery but the risk of thrombosis in factor VII deficient patients treated with NovoSeven is unknown (see section 5.1).
Tveganje za trombozo pri bolnikih s pomanjkanjem FVII, zdravljenih z zdravilom NovoSeven, ni znano (glejte poglavje 5.1).
Once attached, do not remove the vial adapter from the vial.
Ko je nastavek nameščen, ga ne odstranjujte več z viale.
The only complication reported in connection with an overdose was a slight transient increase in blood pressure in a 16 year-old patient receiving 24 mg rFVIIa instead of 5.5 mg.
letnem bolniku, ki je dobil 24 mg rFVIIa namesto 5,5 mg.
Push the plunger rod to inject all the solvent into the vial.
Potiskajte nosilec bata, da boste v vialo vbrizgali vse topilo.
Pull the plunger rod slightly downwards to draw the mixed solution into the syringe.
Potegnite nosilec bata rahlo navzdol, da boste zmešano raztopino potegnili v brizgo.
• The syringe with adequately reconstituted product is now ready for administration in a CEmarked infusion pump (accepting a 50 ml syringe).
• Brizga z ustrezno pripravljenim zdravilom je zdaj pripravljena za dajanje z infuzijsko črpalko