natgillin/translations-raw huggingface dataset:
In major surgery, the dose should be continued at 2 - 4 hour intervals for 6 - 7 days.
Po večjih operacijah je treba z odmerkom nadaljevati v 2 - do 4- urnih presledkih 6 do 7 dni.
Dose and dose interval NovoSeven should be given as early as possible after the start of a bleeding episode.
Odmerek in odmerni interval NovoSeven je treba aplicirati čim prej po začetku krvavitve.
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.
3 Dose, dose range and dose interval The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μ g per kg body weight every 4 - 6 hours until haemostasis is achieved.
Odmerek, odmerno območje in odmerni interval Priporočeno odmerno območje za zdravljenje in preprečevanje krvavitev pri bolnikih, ki so prestali operacijo ali invazivni postopek, je od 15 do 30 µg na kg telesne mase na 4 do 6 ur, dokler ni dosežena hemostaza.
Dose and frequency of injections should be adapted to each individual.
Odmerek in pogostnost injiciranja je treba prilagoditi individualno.
Glanzmann’ s thrombasthenia
3 Glanzmannova trombastenija
Dose, dose range and dose interval The recommended dose for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 90 µg (range 80 - 120 µg) per kg body weight at intervals of two hours (1.5 - 2.5 hours).
Odmerek, odmerno območje in odmerni interval Priporočeni odmerek za zdravljenje krvavitev in za preprečevanje krvavitev pri bolnikih, ki so prestali operacije ali invazivne postopke, je 90 µg (razpon od 80 do 120 µg) na kg telesne mase v dveurnih presledkih (od 1, 5 do 2, 5 ure).
For those patients who are not refractory, platelets are the first line treatment for Glanzmann’ s thrombasthenia.
Pri bolnikih, ki niso refraktarni, so prva izbira zdravljenja Glanzmannove trombastenije trombociti.
Reconstitute the solution as described under section 6.6 and administer as an intravenous bolus injection over 2 - 5 minutes.
Raztopino pripravite, kot je opisano v poglavju 6. 6, in jo aplicirajte v 2 - do 5- minutni intravenski bolusni injekciji.
Monitoring of treatment – Laboratory Tests
Nadziranje zdravljenja – laboratorijske preiskave
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 NovoSeven.
After administration of NovoSeven, prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and aPTT and clinical efficacy of NovoSeven.
Dokazano je, da se po uporabi zdravila NovoSeven protrombinski čas (PČ) in aktivirani parcialni tromboplastinski čas (aPTČ) skrajšata, vendar ni ugotovljeno, da bi PČ in aPTČ korelirala s klinično učinkovitostjo tega zdravila.
Hypersensitivity to the active substance, or to any of the excipients, or to mouse, hamster or bovine protein.
Preobčutljivost za zdravilno učinkovino, katero koli pomožno snov ali mišje, hrčkove ali goveje beljakovine.
Because of the risk of thromboembolic complications, caution should be excercised when administering NovoSeven to patients with a history of coronary heart disease, to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation.
Zaradi tveganja trombemboličnih zapletov morate zdravilo NovoSeven uporabljati previdno pri bolnikih z anamnezo koronarne bolezni, bolnikih z boleznijo jeter, bolnikih po operacijah, novorojenčkih in pri bolnikih, pri katerih obstaja tveganje za trombembolične pojave ali diseminirano intravaskularno koagulacijo.
As recombinant coagulation factor 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.
Rekombinantni koagulacijski faktor NovoSeven lahko vsebuje sledi mišjih IgG, govejih 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.
In such cases treatment with antihistamines i. v. should be considered.
V takšnih primerih je treba razmisliti o zdravljenju z intravenskimi antihistaminiki.
4 patient should be advised to discontinue use of the product immediately and contact their physician.
Bolniku je treba naročiti, da mora v primeru pojava takšnih simptomov nemudoma prenehati uporabljati zdravilo in se mora posvetovati z zdravnikom.
In case of severe bleeds the product should be administered in hospitals preferably specialized in treatment of haemophilia patients with coagulation factor VIII or IX inhibitors, or if not possible in close collaboration with a physician specialized in haemophilia treatment.
V primeru hudih krvavitev je treba zdravilo aplicirati v bolnišnici, po možnosti tam, kjer so specializirani za zdravljenje bolnikov s hemofilijo z zaviralci koagulacijskih faktorjev VIII in IX – če to ni mogoče, pa v tesnem sodelovanju z zdravnikom, specializiranim za zdravljenje hemofilije.
If bleeding is not kept under control hospital care is mandatory.
4 Če krvavitve ni moč obvladati, je obvezno zdravljenje v bolnišnici.
Patients/ carers should inform the physician/ supervising hospital at the earliest possible opportunity about all usages of NovoSeven.
Bolniki oz. tisti, ki zanje skrbijo, morajo zdravnika oz. nadzorno bolnišnico obvestiti o vseh uporabah zdravila NovoSeven, čim prej je mogoče.
The risk of thrombosis in factor VII deficient patients treated with NovoSeven is unknown.
Tveganje za trombozo pri bolnikih s pomanjkanjem faktorja VII, ki dobivajo NovoSeven, ni znano.
Experience with concomitant administration of anti-fibrinolytics and NovoSeven treatment is however limited.
Vendar so izkušnje s sočasno uporabo antifibrinolitikov in zdravila NovoSeven omejene.
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.
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.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see 5.3).
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
It is not known whether rFVIIa is excreted in human milk.
Uporaba med obdobjem dojenja: ni znano, ali se rFVIIa pri človeku izloča v materinem mleku.
No effects on the breastfed newborn/ infant are anticipated.
Učinkov na dojenega novorojenčka/ dojenčka ni pričakovati.
NovoSeven can be used during breast-feeding.
Zdravilo NovoSeven lahko uporabljate med obdobjem dojenja.
Based on post-marketing experience adverse drug reactions are rare (< 1 per 1,000 standard doses).
Glede na pomarketinške izkušnje so neželeni učinki na zdravilo redki (< 1 na 1. 000 standardnih odmerkov).
When analysed by system organ classes, the reporting rates of adverse drug reactions during the post- marketing period, including both serious and non-serious reactions, are as indicated in the table below:
Deleži neželenih učinkov na zdravilo, o katerih so poročali med pomarketinškim obdobjem (tako resne kot manj resne reakcije), so navedeni v spodnji preglednici, razčlenjeni po organskih sistemih:
Blood and lymphatic disorders Very rare (< 1/ 10,000)
Bolezni krvi in limfatičnega sistema Zelo redko (< 1/ 10. 000)
Few cases of coagulopathic disorders such as increased D-dimer and consumptive coagulopathy have been reported.
Opisanih je bilo nekaj primerov koagulopatskih motenj, npr. zvišanja D - dimera in porabnostne koagulopatije.
Patients at increased risk of disseminated intravascular coagulation as described in section 4.4 should be carefully monitored.
Bolnike, ki jih posebej ogroža diseminirana intravaskularna koagulacija, kot je opisano v poglavju 4. 4, je treba natančno nadzirati.
Cardiac disorders
Zelo redko (< 1/ 10. 000)
Described below under ‘ serious adverse reactions
Miokardni infarkt: glejte opis spodaj pod "Resni neželeni učinki, opisani med pomarketinškim obdobjem".
Gastrointestinal disorders Very rare (< 1/ 10,000)
5 Bolezni prebavil Zelo redko (< 1/ 10. 000)
General disorders and administration site conditions Rare (> 1/ 10,000, < 1/ 1,000)
Splošne težave in spremembe na mestu aplikacije Redko (> 1/ 10. 000, < 1/ 1. 000)
Lack of efficacy (therapeutic response decreased) has been reported.
Opisano je bilo pomanjkanje učinkovitosti (zmanjšan terapevtski odziv).
It is important that the dosage regimen of NovoSeven is compliant with the recommended dosage as stated in section 4.2.
Pomembno je, da je režim odmerjanja NovoSeven v skladu z odmernimi priporočili, navedenimi v poglavju 4. 2.
Very rare (< 1/ 10,000)
Zelo redko (< 1/ 10. 000)
Fever may occur.
Pojavi se lahko zvišana telesna temperatura.
Pain, especially at injection site may also occur on rare occasions.
V redkih primerih se lahko pojavijo tudi bolečine, zlasti na injekcijskem mestu.
Increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin levels have been reported.
Opisane so bile zvišane vrednosti alanin- aminotransferaze, alkalne fosfataze, laktat- dehidrogenaze in protrombina.
Cerebrovascular disorders including cerebral infarction and cerebral ischaemia have been reported:
Bolezni živčevja Zelo redko (< 1/ 10. 000)
Described below under ’ serious adverse reactions reported during the post-marketing period’.
Poročali so o cerebrovaskularnih motnjah, vključno z možganskim infarktom in možgansko ishemijo: glejte opis spodaj pod "Resni neželeni učinki, opisani med pomarketinškim obdobjem".
Skin and subcutaneous tissue disorders Very rare (< 1/ 10,000)
Bolezni kože in podkožja
Skin rashes may occur.
Zelo redko (< 1/ 10. 000)
Vascular disorders
Žilne bolezni Zelo redko (< 1/ 10. 000)
Very rare (< 1/ 10,000)
Opisani so bili hemoragični dogodki.
Venous thrombotic events have been reported:
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Described below under ’ serious adverse reactions reported during the post-marketing period ’ Incidents of haemorrhage have been reported.
Med resnimi neželenimi učinki, opisanimi med pomarketinškim obdobjem, so:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
- arterijski trombotični dogodki, npr. miokardni infarkt ali ishemija, cerebrovaskularne motnje in
Serious adverse reactions reported during the post-marketing period include: – Arterial thrombotic events such as myocardial infarctions or ischaemia, cerebrovascular disorders and bowel infarction.
V veliki večini primerov je pri bolnikih obstajala nagnjenost k arterijskim trombotičnim motnjam, bodisi zaradi osnovne bolezni, starosti ali ateroskleroze bodisi zaradi trenutnega zdravstvenega stanja, kot je opisano v poglavju 4. 4;
In the vast majority of cases the patients were predisposed to arterial thrombotic disorders either due to underlying disease, age, atherosclerotic or current medical conditions as described in section 4.4 – Venous thrombotic events such as thrombophlebitis, deep vein thrombosis and hereto related pulmonary embolism.
- venski trombotični dogodki, npr. tromboflebitis, globoka venska tromboza in s tem povezana
In the vast majority of cases the patients were predisposed to venous thrombotic events due to concurrent risk factors.
V veliki večini primerov je zaradi hkratnih dejavnikov tveganja pri bolnikih obstajala nagnjenost k venskim trombotičnim motnjam.
Patients at increased risk of venous thrombotic disorders either due to concurrent conditions, previous history of thrombotic events, post surgery immobilisation or venous catheterisation should be carefully monitored – Thrombotic events of the liver.
Bolnike, ki imajo zvečano tveganje za venske trombotične motnje, bodisi zaradi sočasnih bolezni, anamneze trombotičnih dogodkov, pooperacijske imobilizacije ali venske katetrizacije, je treba natančno nadzirati;
In the vast majority of cases the patients were predisposed due to liver disease or liver surgery.
V veliki večini primerov je pri bolnikih obstajala nagnjenost zaradi
Isolated cases of hypersensitivity reactions including anaphylactic reactions have been reported post- marketing.
Med pomarketinškim obdobjem so bili poročani posamezni primeri preobčutljivostnih in anafilaktičnih reakcij.
Patients with a history of allergic reactions should be carefully monitored.
Bolnike z anamnezo alergijskih reakcij je treba natančno nadzirati.
There have been no reports of antibodies against factor VII in haemophilia A or B patients.
Pri bolnikih s hemofilijo A ali B niso poročali o protitelesih proti faktorju VII.
Isolated cases of factor VII deficient patients developing antibodies against factor VII have been reported after treatment with NovoSeven.
Opisani so posamezni primeri bolnikov s pomanjkanjem faktorja VII, ki so se jim po zdravljenju z NovoSeven pojavila protitelesa proti faktorju VII.
These patients have previously been treated with human plasma and/ or plasma-derived factor VII.
Ti bolniki so bili predhodno zdravljeni s človeško plazmo in/ ali faktorjem VII, pridobljenim iz plazme.
In two patients the antibodies showed inhibitory effect in vitro.
Pri dveh bolnikih so imela protitelesa zaviralen učinek in vitro.
Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies.
Bolnike s pomanjkanjem faktorja VII je treba nadzirati glede prisotnosti protiteles proti temu faktorju.
6 One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of NovoSeven.
6 Spontano je bil prijavljen en primer angionevrotičnega edema po uporabi zdravila NovoSeven pri bolniku z Glanzmannovo trombastenijo.
A thrombotic event has been reported in an elderly (> 80 year) male patient with factor VII deficiency treated with 10 - 20 times the recommended dose.
Poročali so o trombotičnem zapletu pri starejšem (> 80 let) bolniku moškega spola s pomanjkanjem faktorja VII, zdravljenim z 10- 20 krat višjim odmerkom, kot je priporočeno.
No other thrombotic complications from overdose have been reported, not even after treatment of a 6 year old boy with haemophilia A with inhibitors with 8 - 10 times the recommended dose.
O drugih trombotičnih zapletih zaradi prevelikega odmerka niso poročali, in sicer niti pri šestletnem dečku s hemofilijo A, zdravljenim z zaviralci v 8- 10 krat večjem odmerku kot je priporočeno.
Blood coagulation factors, ATC code:
Farmakoterapevtska skupina: krvni koagulacijski faktorji, oznaka ATC:
B02B D08
B02BD08.
NovoSeven contains activated recombinant coagulation factor VII.
NovoSeven vsebuje aktivirani rekombinantni koagulacijski faktor VII.
Accordingly, the pharmacodynamic effect of factor VIIa gives rise to an increased local formation of factor Xa, thrombin and fibrin.
Glede na to povzroči farmakodinamični učinek faktorja VIIa zvečano lokalno nastajanje faktorja Xa, trombina in fibrina.
A theoretical risk for the development of systemic activation of the coagulation system in patients suffering from underlying diseases predisposing them to DIC cannot be totally excluded.
5. 2 Farmakokinetične lastnosti
Using the FVII clotting assay, the pharmacokinetics of NovoSeven were investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study.
Farmakokinetiko zdravila NovoSeven so v študiji s povečevanjem odmerka raziskali pri 35 zdravih belskih in japonskih preiskovancih s koagulacijskim preizkusom z FVII.
Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg NovoSeven per kg body weight and/ or placebo (3 doses each).
Dobili so 40, 80 in 160 µg zdravila NovoSeven na kilogram telesne mase in/ ali placebo (3 odmerke vsakega).
The mean steady state volume of distribution ranged from 130 to 165 ml/ kg, the mean values of clearance ranged from 33.3 to 37.2 ml/ kg. h, and the mean terminal half-life ranged from 3.9 to 6.0 hours.
Povprečen volumen porazdelitve v stanju dinamičnega ravnovesja je bil od 130 do 165 ml/ kg, povprečna vrednost očistka je segala od 33, 3 do 37, 2 ml/ kg. h, povprečni terminalni razpolovni čas pa od 3, 9 do 6, 0 ur.
Using the FVIIa assay, the pharmacokinetic properties of NovoSeven were studied in 12 paediatric (2 - 12 years) and 5 adult patients in non bleeding state.
Farmakokinetične lastnosti zdravila NovoSeven so s preizkusom z FVIIa raziskali pri 12 pediatričnih (2- 12 let) in 5 odraslih bolnikih, ki niso krvaveli.
Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/ kg rFVIIa).
Pri otrocih so ob uporabi raziskovanih odmerkov 90 in 180 µg na kilogram telesne mase ugotovili sorazmernost odmerku, kar se ujema s prejšnjimi izsledki pri manjših odmerkih (17, 5– 70 µg/ kg rFVIIa).
Mean clearance was approximately 50% higher in paediatric patients relative to adults (78 versus 53 ml/ kg. h), whereas the mean terminal half life was determined to 2.3 hours in both groups.
Povprečni očistek je bil pri pediatričnih bolnikih približno 50% večji kot pri odraslih (78 v primerjavi s 53 ml/ kg. h), ugotovljeni povprečni terminalni razpolovni čas pa je bil v obeh skupinah 2, 3 ure.
Mean volume of distribution at steady state was 196 ml/ kg in paediatric patients versus 159 ml/ kg in adults.
Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja je bil pri pediatričnih bolnikih 196 ml/ kg in pri odraslih 159 ml/ kg.
Clearance appears related with age, therefore in younger patients clearance may be increased by more than 50%.
Kot kaže, je očistek povezan s starostjo, zato je lahko očistek pri mlajših bolnikih za več kakor 50% večji.
Single dose pharmacokinetics of NovoSeven, 15 and 30 μ g per kg body weight, showed no significant
7 Farmakokinetika posamičnih odmerkov zdravila NovoSeven 15 in 30 µg na kg telesne mase se med odmerkoma ni značilno razlikovala po parametrih, neodvisnih od odmerka: skupnem telesnem očistku (70, 8– 79, 1 ml / kg. h), volumnu porazdelitve v stanju dinamičnega ravnovesja (280– 290 ml/ kg), povprečnem času zadrževanja (3, 75– 3, 80 ure) in razpolovnem času (2, 82– 3, 11 ure).
The mean in vivo plasma recovery was approximately 20%.
Povprečna in vivo obnova v plazmi je bila približno 20%.
Glanzmann’ s thrombasthenia
Glanzmannova trombastenija
Pharmacokinetics of NovoSeven in patients with Glanzmann’ s thrombasthenia have not been investigated, but are expected to be similar to the pharmacokinetics in haemophilia A and B patients.
Farmakokinetika zdravila NovoSeven pri bolnikih z Glanzmannovo trombastenijo ni raziskana, vendar je mogoče pričakovati, da je podobna farmakokinetiki pri bolnikih s hemofilijo A in B.
All findings in the preclinical safety programme were related to the pharmacological effect of NovoSeven.
Vsi izsledki v programu predklinične varnosti so bili povezani s farmakološkim učinkom zdravila NovoSeven.
Powder Sodium chloride Calcium chloride dihydrate Glycylglycine Polysorbate 80 Mannitol Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Prašek natrijev klorid kalcijev klorid dihidrat glicilglicin polisorbat 80 manitol klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
The shelf life is 3 years for the product packed for sale.
Rok uporabnosti zdravila, pakiranega za prodajo, je 3 leta.
After reconstitution, chemical and physical stability has been demonstrated for 24 hours at 25°C.
Po pripravi je kemična in fizikalna stabilnost dokazana za 24 ur pri temperaturi 25 °C.
If not used immediately, storage time and storage conditions prior to use are the responsibility of the user, and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila priprava opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
6.4 Special precautions for storage
NovoSeven shranjujte v hladilniku (2 °C - 8 °C).
– Store NovoSeven in a refrigerator (2°C - 8°C) – Store in original package in order to protect from light – Do not freeze to prevent damage to the solvent vial.
- Shranjujte v originalni ovojnini, da boste zagotovili zaščito pred svetlobo.
6.5 Nature and contents of container
- Ne zamrzujte, da boste preprečili poškodbo viale z vehiklom.
Vials for NovoSeven:
6. 5 Vrsta ovojnine in vsebina
Glass closed with a bromobutyl rubber stopper covered with an aluminium cap.
Viale z zdravilom NovoSeven: steklene, zaprte z zamaškom iz brombutilne gume, prekritim z aluminijsko zaporko.
8 The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
8 Zaprte viale so opremljene z zaščitnim odlomnim pokrovčkom iz polipropilena.
Glass closed with a bromobutyl rubber disc with teflon, covered with an aluminium cap.
Viale z vehiklom: steklene, zaprte z brombutilno gumijasto ploščico s teflonom, prekrito z aluminijsko zaporko.
The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
Zaprte viale so opremljene z zaščitnim odlomnim pokrovčkom iz polipropilena.
Syringe for reconstitution and administration:
Brizga za pripravo in apliciranje:
The sterile disposable syringe is made of polypropylene.
Sterilna injekcijska brizga za enkratno uporabo je izdelana iz polipropilena.
The NovoSeven package contains: – 1 vial (2 ml) with white powder (NovoSeven) for solution for injection – 1 vial (2 ml) with solvent (Water for injections) for reconstitution – 1 sterile vial adapter for reconstitution – 1 sterile disposable syringe for reconstitution and administration – 1 sterile infusion set for administration – 2 alcohol swabs for cleansing the rubber stoppers on the vials – Package leaflet with instructions for use.
Pakiranje NovoSeven vsebuje:
6.6 Special precautions for disposal and other handling
- 1 vialo (2 ml) z belim praškom (NovoSeven) za raztopino za injiciranje,
Always use an aseptic technique
- 1 vialo (2 ml) z vehiklom (voda za injiciranje) za pripravo,
Reconstitution
- 1 sterilno iglo za pripravo (igla za prenos),
• Bring the NovoSeven powder and water vials to room temperature (but not above 37°C).
- 1 sterilno brizgo za enkratno uporabo, namenjeno za pripravo in apliciranje,
You can do this by holding them in your hands.
- 1 sterilen infuzijski komplet,
Remove the plastic caps from the two vials.
- 2 z alkoholom prepojena zloženca za dezinficiranje gumijastih zamaškov vial,
Clean the rubber stoppers on the vials with the alcohol swabs and allow them to dry before use. • Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
• Z nastavka za vialo odstranite zaščitni papir, vendar nastavka ne vzemite iz zaščitnega pokrovčka.
• 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).
• Izvlecite bat brizge, da boste vanjo potegnili toliko zraka, kolikor je topila v viali s topilom (mililitri ustrezajo oznaki cc na brizgi).
• Screw the syringe tightly onto the vial adapter on the solvent vial.
• Brizgo trdno privijte na nastavek za vialo, nameščen na viali s topilom.