natgillin/translations-raw huggingface dataset:
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Theraloc could not have been approved for the treatment of children and adolescents with recurrent high-grade glioma.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Theraloc ni mogoče odobriti za zdravljenje otrok in mladostnikov s ponavljajočim gliomom visoke stopnje.
Theraloc is a concentrate that is made up into a solution for infusion (drip into a vein).
Zdravilo Theraloc je koncentrat, ki se pripravi v raztopino za infundiranje (vnašanje po kapljicah v veno).
The active substance in Theraloc, nimotuzumab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Theraloc, nimotuzumab, je monoklonsko protitelo.
What was Theraloc expected to be used for?
Za kaj naj bi se zdravilo Theraloc uporabljalo?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Theraloc.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Theraloc.
When activated, EGFR helps the tumour cells grow, multiply and spread.
Ko je receptor za epidermalni rastni faktor aktiviran, pomaga pri rasti, razmnoževanju in širjenju tumorskih celic.
How is Theraloc expected to work?
Kako naj bi zdravilo Theraloc delovalo?
The CHMP was concerned that the company had not supplied sufficient evidence to demonstrate that Theraloc could be made in a reliable manner, and that insufficient information was provided on the way the product was treated by the body.
CHMP je bil izrazil zaskrbljenost, da družba ni predložila zadostnih dokazov glede zanesljivosti priprave zdravila Theraloc in da so podatki o presnovi zdravila v telesu nezadostni.
It contains the active substance nimotuzumab.
Vsebuje zdravilno učinkovino nimotuzumab.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Theraloc had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je v času umika menil, da koristi zdravila Theraloc niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
By blocking EGFR, nimotuzumab was expected to slow down the progression of glioma.
Pričakovali so, da bo nimotuzumab z zaviranjem receptorjev za epidermalni rastni faktor upoèasnil napredovanje glioma.
(Study 070701)
(študija 070701)
Do not infuse any faster than 4 mL per minute.
Ne infundirajte hitreje kot 4 ml na minuto.
Filtration does not influence dosage calculations.
Filtracija ne vpliva na izračune odmerka.
2304 Orth an der Donau AUSTRIA
2304 Orth an der Donau AVSTRIJA
Chemical and physical in-use stability has been demonstrated for 3 hours at 25°C.
Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za obdobje 3 ur pri temperaturi 25 °C.
In all three studies, subjects were evaluated in the non-bleeding state.
V vseh treh študijah so bili preiskovanci ocenjeni v stanju brez krvavitve.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
ATC code: B02BD10
Oznaka ATC: B02BD10
In patients with the disease the blood does not clot normally leading to a prolonged bleeding time.
Pri bolnikih z boleznijo se kri ne strjuje normalno, kar vodi do podaljšanega časa krvavitve.
This will be checked by your doctor.
Zdravnik bo stanje preveril.
It is used when treatment with another medicine, desmopressin, is not effective or cannot be given.
Uporablja se, če zdravljenje z drugim zdravilom, dezmopresinom, ni učinkovito ali ne pride v poštev
If such inhibitors occur, the condition may manifest itself as an inadequate clinical response.
Če se pojavijo taki inhibitorji, se bo stanje lahko pokazalo kot nezadosten klinični odziv.
Neutralizing antibodies (Inhibitors)
Nevtralizirajoča protitelesa (inhibitorji)
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ker je o teh reakcijah prostovoljno poročala populacija neznane velikosti, ni vedno mogoče zanesljivo oceniti pogostosti ali določiti vzorčne povezave z izpostavitvijo zdravilu.
Frequency categories are defined 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).
Kategorije pogostnosti so bile opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Start of treatment
Začetek zdravljenja
Within each frequency grouping, undesirable effects are presented in the order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Severe symptoms, including difficulty in breathing and dizziness, require prompt emergency treatment.
Hudi simptomi, med katere sodijo težave z dihanjem in omotica, zahtevajo takojšnje nujno medicinsko zdravljenje.
In general, the frequency of VEYVONDI dosing for post-operative substitution should range from twice a day to every 48 hours.
Na splošno mora biti pogostnost odmerjanja zdravila VEYVONDI za pooperativno nadomeščanje od dvakrat na dan do na vsakih 48 ur.
These could be early symptoms of a hypersensitivity reaction.
To so lahko zgodnji simptomi preobčutljivostne reakcije.
Your doctor may adjust the dose according to your laboratory results.
Zdravnik vam bo morda glede na rezultate laboratorijskih preiskav prilagodil odmerek.
FVIII products may contain varying amounts of VWF.
Zdravila s FVIII lahko vsebujejo različne količine VWF.
The rate of administration should be slow enough to ensure the comfort of the patient, up to a maximum of 4 mL/min.
Hitrost dajanja mora biti dovolj počasna, da zagotavlja ugodje bolnika, znašati pa sme do največ 4 ml/min.
Doing so may harm medicine.
S tem lahko škodujete zdravilu.
Do not dispose of these supplies in ordinary household trash.
Teh pripomočkov ne odvrzite med običajne gospodinjske odpadke.
Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel SWITZERLAND
Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel ŠVICA
- This medicine is for single use only.
- To zdravilo je samo za enkratno uporabo.
Your doctor will calculate your dose of VEYVONDI (in international units or IU).
Zdravnik bo izračunal vaš odmerek zdravila VEYVONDI (v mednarodnih enotah ali i.e.).
EXP: Use immediately or within 3 hours after reconstitution.
EXP: Zdravilo uporabite nemudoma oziroma najpozneje v 3 urah po rekonstituciji.
Detailed instructions for reconstitution and admnistration are given at the end of this package leaflet.
Podrobna navodila za rekonstitucijo in uporabo so navedena na koncu tega navodila za uporabo.
If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VEYVONDI and provide appropriate supportive care.
Če se pojavijo znaki in simptomi hudih alergijskih reakcij, nemudoma prekinite dajanje zdravila VEYVONDI in zagotovite ustrezno podporno oskrbo.
Known allergic reaction to mouse or hamster proteins.
Dokazana alergijska reakcija na beljakovine miši ali hrčka.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben armakovigilančni ali povezan z zmanjševanjem tveganja).
Wash your hands and put on clean exam gloves (the use of gloves is optional).
Umijte si roke in si nadenite čiste rokavice za enkratno uporabo (uporaba rokavic je neobvezna).
Therefore, patients experiencing hypersensitivity or anaphylactic reactions should be tested and evaluated for the presence of an inhibitor.
Zato je treba bolnike s preobčutljivostno ali anafilaktično reakcijo pregledati in oceniti glede navzočnosti inhibitorja.
If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use.
Če uporabljate zdravilo VEYVONDI doma, bo zdravnik poskrbel, da boste poučeni, kako zdravilo infundirati in koliko ga morate uporabiti.
In the 2 spontaneous post-marketing cases reported, the symptoms resolved and the patients fully recovered in 20 minutes to 4 hours upon stopping the infusion.
V dveh spontanih primerih po začetku trženja so simptomi izginili, bolnika pa sta si povsem opomogla po 20 minutah oziroma po 4 urah po prekinitvi infundiranja.
Therefore, patients at risk have to be monitored for early signs of thrombosis, and prophylaxis measures against thromboembolism should be instituted according to current recommendations and standard of care.
Zato je treba bolnike s tveganjem spremljati za zgodnje znake tromboze in uvesti preventivne ukrepe proti trombemboliji v skladu z veljavnimi priporočili in standardom oskrbe.
13 If you need more than one vial of VEYVONDI to make up your dose:
13 Če potrebujete več kot eno vialo zdravila VEYVONDI za vaš odmerek:
You will be monitored carefully for the possibility of having developed these inhibitors.
Zato vas bodo skrbno spremljali glede nastanka teh zaviralcev.
Subsequent infusions:
Naslednje infuzije:
Patients treated with this product may develop hypersensitivity reactions to these non-human mammalian proteins.
Pri bolnikih, ki se zdravijo s tem zdravilom, se lahko pojavijo preobčutljivostne reakcije na te beljakovine sesalcev ne-humanega izvora.
Dosing guidance should be done based on the IR.
Navodila za odmerjanje morajo temeljiti na IR.
• Leave the syringe attached to the vial until an additional vial is prepared.
• Brizgo pustite na viali, dokler ne pripravite dodatne viale.
Adverse Reaction by Preferred Term (PT)
Neželeni učinki po prednostnih izrazih (PT)
Disconnect the empty syringe.
Odstranite prazno brizgo.
The clinical safety, efficacy and PK data were assessed in 3 completed trials, (070701, 071001 and 071101) which enrolled patients with VWD.
Podatke o klinični varnosti, učinkovitosti in farmakokinetiki so ocenili v 3 zaključenih preskušanjih (070701, 071001 in 071101), v katerih so bili vključeni bolniki z VWB.
There is a low risk that you may experience a hypersensitivity reaction (a severe, sudden allergic reaction) to VEYVONDI.
Obstaja majhno tveganje, da bi lahko pri vas nastopila preobčutljivostna reakcija (huda, nenadna alergijska reakcija) na zdravilo VEYVONDI.
In case large volumes of VEYVONDI are required, it is possible to pool two vials of VEYVONDI together.
Če so potrebne velike količine zdravila VEYVONDI, je mogoče združiti dve viali zdravila VEYVONDI.
Lack of VWF increases the tendency to bleed.
Pomanjkanje VWF povzroči nagnjenost h krvavitvam.
Image example
Slikovni primer
The amount of air should equal the amount of reconstituted VEYVONDI that you will withdraw from the vial.
Količina zraka mora biti enaka količini rekonstituiranega zdravila VEYVONDI, ki jo boste odvzeli iz viale.
Healthcare professionals should balance the potential risks and only prescribe VEYVONDI if needed
Zdravnik mora presoditi morebitna tveganja in predpisati zdravilo VEYVONDI le po potrebi.
Table 5 Pharmacokinetic Assessment of VWF:RCo f
Preglednica 5 Farmakokinetična ocena VWF:RCo f
Experience in the treatment of pregnant or breast-feeding women is not available.
Izkušenj z zdravljenjem pri nosečnicah ali doječih materah ni.
VEYVONDI should not be used in the treatment of Haemophilia A.
Zdravilo VEYVONDI se ne sme uporabljati pri zdravljenju hemofilije A.
14 The contents of two vials may be drawn into a single syringe.
14 Vsebino dveh vial lahko povlečete v eno brizgo.
You can have an allergic reaction to VEYVONDI.
Lahko imate alergijsko reakcijo na zdravilo VEYVONDI.
Use the reconstituted product (after mixing the powder with the supplied water) as soon as possible and within three hours.
Rekonstituirano zdravilo (po mešanju praška s priloženo vodo) porabite čimprej, najkasneje v treh urah.
It is manufactured by recombinant DNA (rDNA) technology in the Chinese Hamster Ovary (CHO) cell line without the addition of any exogenous human-or animal-derived protein in the cell culture process, purification or final formulation.
Izdelan je s tehnologijo rekombinantne DNA (rDNA) v celični liniji jajčnika kitajskega hrčka (CHO) brez dodajanja eksogenih človeških ali živalskih beljakovin pri postopku celične kulture, prečiščevanja ali končne priprave.
The safety and efficacy of VEYVONDI in children aged 0 to 18 years have not yet been established.
Varnost in učinkovitost zdravila VEYVONDI pri otrocih, starih od 0 do 18 let, še nista bili dokazani.
This should be taken into consideration if you are on a controlled sodium diet.
To je treba upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
VEYVONDI is usually infused into a vein (intravenously) by your doctor or nurse.
Zdravilo VEYVONDI vam običajno v veno (intravensko) infundira zdravnik ali medicinska sestra.
It is strongly recommended that every time that VEYVONDI 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 product.
Zelo priporočljivo je, da se vsakič, ko bolnik prejme zdravilo VEYVONDI, zabeležita ime in serijska številka zdravila, da se ohrani povezava med bolnikom in serijo zdravila.
Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.
Zdravnik bo izračunal odmerek zdravila VEYVONDI, ki je najbolj primeren za vas, kako pogosto in kako dolgo ga morate prejemati.
VEYVONDI is a rVWF that contains ultra-large multimers in addition to all of the multimers found in plasma as it is not exposed to proteolysis by ADAMTS13 during the manufacturing process.
Zdravilo VEYVONDI je faktor rVWF, ki poleg vseh multimerov v plazmi vsebuje zelo velike multimere, saj med izdelavo ni izpostavljen proteolizi z ADAMTS13.
A bleed could be considered major if red blood cell transfusion is either required or potentially indicated or if bleeding occurs in a critical anatomical site (e.g., intracranial or gastrointestinal haemorrhage).
Krvavitev se lahko šteje za večjo, če je transfuzija rdečih krvnih celic potrebna ali potencialno indicirana ali če se krvavitev pojavi na kritičnem anatomskem mestu (npr. krvavitev v glavi ali prebavilih).
In major bleeding episodes, maintain trough levels of VWF:RCo greater than 50% for as long as deemed necessary.
Pri večjih krvavitvah vzdržujte najnižje ravni VWF:RCo višje od 50 % toliko časa, kolikor je to potrebno.
Sustained increase of FVIII:C was observed by six hours after a single infusion of VEYVONDI.
Trajno zvišanje ravni FVIII:C so opazili šest ur po enkratni infuziji zdravila VEYVONDI.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če zdravila ne uporabite takoj, je za čas shranjevanja zdravila v odprti embalaži in pogoje pred uporabo odgovoren uporabnik, pri čemer naj čas shranjevanja ne bi bil daljši od 24 ur pri temperaturi od 2 do 8 °C, razen če je bila rekonstitucija opravljena v nadzorovanih in validiranih aseptičnih pogojih.
Place the vials on a flat surface.
Viali položite na ravno površino.
The complete dose of VEYVONDI should be administered followed by rFVIII within 10 minutes.
Treba je dati celoten odmerek zdravila VEYVONDI, ki mu v 10 minutah sledi rFVIII.
Based on experience from clinical studies, once VWF has been replaced, endogenous FVIII levels will remain normal or near normal as long as VEYVONDI is continued to be administered.
Na podlagi izkušenj iz kliničnih študij ravni endogenega FVIII po nadomestitvi VWF ostanejo normalne ali skoraj normalne, dokler dajemo zdravilo VEYVONDI.
Von Willebrand disease is an inherited bleeding disorder caused by the lack or an insufficient amount of von Willebrand factor.
Von Willebrandova bolezen je prirojena motnja strjevanja krvi, ki jo povzroča pomanjkanje ali nezadostna količina von Willebrandovega faktorja.
If flakes or particles are seen, do not use the solution and notify your doctor.
Če opazite kosmiče ali delce, ne uporabljajte raztopine in obvestite svojega zdravnika.
The dose depends on: - body weight, - the site of the bleeding - intensity of the bleeding, - your clinical condition, - the required surgery - the VWF activity levels in your blood after surgery - the severity of your disease
Odmerek je odvisen od: - telesne mase, - mesta krvavitve, - intenzivnosti krvavitve, - vašega klinično stanje, - potrebnega kirurškega posega, - ravni aktivnosti VWF v krvi po posegu, - resnosti vaše bolezni.
VEYVONDI has no or negligible influence on the ability to drive and use machines.
Zdravilo VEYVONDI nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Treatment of bleeding episodes (On demand treatment)
Zdravljenje krvavitev (zdravljenje po potrebi)
The European Medicines Agency has deferred the obligation to submit the results of studies with VEYVONDI in all subsets of the paediatric population in the treatment of von Willebrand Disease (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom VEYVONDI za vse podskupine pediatrične populacije za zdravljenje von Willebrandove bolezni (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle.
Iglo usmerite navzgor in odstranite morebitne zračne mehurčke tako, da s prsti narahlo potrkate po brizgi ter počasi in previdno potisnite bat, da odstranite zrak iz brizge in igle.
After reconstitution For storage conditions after reconstitution of the medicinal product, see section 6.3.
Po rekonstituciji Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
Major b
Večja b
For comfort, a winged (butterfly) infusion set is preferred.
Zaradi udobja je priporočen infuzijski komplet s krilci (metuljčkom).
VWF:RCo x BW (kg) /IR
VWF:RCo x TM (kg)/IR
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za zagotovitev sledljivosti biološkega zdravila, si natančno zabeležite ime in serijsko številko uporabljenega zdravila.
Such antibodies may occur in close association with hypersensitivity or anaphylactic reactions.
Taka protitelesa se lahko pojavijo v tesni povezavi s preobčutljivostjo ali anafilaktičnimi reakcijami.
If you previously had problems with blood clots or vessel occlusion (thromboembolic complications), tell your doctor immediately.
Če ste kdaj imeli težave s krvnimi strdki ali zamašitvijo žil (trombembolični zapleti), morate to nemudoma povedati zdravniku.
The contents of each reconstituted product of VEYVONDI can be drawn in a single syringe.
Vsebino vsakega rekonstituiranega zdravila VEYVONDI lahko povlečete v eno brizgo.
Administered intravenously, VEYVONDI binds to endogenous factor VIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation.
Z intravenskim dajanjem se zdravilo VEYVONDI veže na endogeni faktor VIII (ki ga bolnik tvori normalno) in ga stabilizira ter tako prepreči njegovo hitro razgradnjo.
The solution should be slowly administered intravenously (see section 4.2) not exceeding 4 mL/min.
Raztopino počasi intravensko injicirajte (glejte poglavje 4.2) in pazite, da ne presežete hitrosti 4 ml/min.
Haemostasis cannot be ensured until Factor VIII coagulant activity (FVIII:C) is at least 0.4 IU/mL (≥ 40% of normal activity).
Hemostaze ni mogoče zagotoviti, dokler aktivnost koagulacijskega faktorja VIII (FVIII:C) ne dosega vsaj 0,4 i.e./ml (≥ 40 % normalne aktivnosti).
3 Open the Mix2Vial device package by completely peeling away the lid, without touching the inside of the package.
3 Pakiranje pripomočka Mix2Vial odprite tako, da popolnoma odlepite pokrov, ne da bi se dotaknili notranjosti.
Treatment of VWD patients who have high-titer binding antibodies (due to previous treatment with pdVWF) may require a higher dose to overcome the binding antibody effect and such patients could be managed clinically by administration of higher doses of vonicog alfa based on the PK data for each individual patient.
Za zdravljenje bolnikov z VWB, ki imajo visok titer vezavnih protiteles (zaradi predhodnega zdravljenja s pdVWF), je morda potreben večji odmerek, da se premaga učinek vezavnih protiteles; taki bolniki se lahko klinično vodijo z dajanjem večjih odmerkov vonikoga alfa glede na farmakokinetične podatke posameznega bolnika.
However, in these cases the initially reconstituted solution should not be diluted any further.
Vendar pa v tem primeru prvotno rekonstituirane raztopine zdravila ne smete dodatno redčiti.
In patients with high levels of anti-VWF antibodies, von Willebrand factor therapy may not be effective and other therapeutic options should be considered.
Pri bolnikih z visoko ravnijo protiteles proti VWF zdravljenje z von Willebrandovim faktorjem morda ne bo učinkovito, zato je treba razmisliti o drugih možnostih zdravljenja.
If any reaction, such as tachycardia, occurs that might be related to the administration of the product, the rate of infusion should be reduced or stopped as required by the clinical condition of the patient.
Če se pojavi kakršna koli reakcija, ki bi lahko bila povezana z dajanjem zdravila, kot je tahikardija, je treba hitrost infundiranja zmanjšati ali infundiranje ustaviti, kot zahteva klinično stanje bolnika.
6 Gently and continuously swirl the connected vials or allow the reconstituted product to stand for 5 minutes then gently swirl to ensure the powder is completely dissolved.
6 Nežno in brez prekinitev vrtite priključeni viali oziroma pustite rekonstituirano zdravilo 5 minut, nato pa ga rahlo vrtite, da se prepričate, da se je prašek popolnoma raztopil.
See section 2 “VEYVONDI contains sodium”.
Glejte poglavje 2 „Zdravilo VEYVONDI vsebuje natrij“.
No investigations on carcinogenicity, fertility impairment and fetal development have been conducted.
Raziskave karcinogenosti, okvar plodnosti in učinkov na razvoj ploda niso bile opravljene.
VWF is the carrier molecule for coagulation factor VIII and is involved in blood clotting making platelets stick to wounds and so helps to form a blood clot.
VWF je nosilna molekula za koagulacijski faktor VIII in je vključena v strjevanje krvi tako, da prispeva k lepljenju krvnih ploščic na rano in tako pripomore k nastanku krvnega strdka.
If you have previously been treated with plasma-derived VWF concentrates you may have reduced response to VEYVONDI due to pre-existing antibodies.
Če ste se predhodno zdravili s koncentrati VWF, pridobljenimi iz plazme, je vaš odziv na zdravilo VEYVONDI zaradi obstoječih protiteles lahko zmanjšan.
The contents of each vial of rVWF and rFVIII can be drawn into a single syringe by using a separate unused reconstitution device (see 6.2 for incompatibilities).
Vsebino posamezne viale rVWF in rFVIII lahko povlečete v eno brizgo, in sicer z uporabo ločenih, še neuporabljenih pripomočkov za rekonstitucijo (glede inkompatibilnosti glejte poglavje 6.2).