FrancophonIA/ELRC3.0 huggingface dataset:
English: Attach the dosing syringe to the plug-in adapter of the bottle by gently pushing.
Slovenian: Merilno brizgo nežno potisnite in tako priključite na adapter, ki se potisne v plastenko.
English: Administration of the product at overdose (3 to 5 times of the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN; nitrogen containing waste products in the blood).
Slovenian: Dajanje prevelikega odmerka zdravila (3 do 5-kratni priporočeni odmerek 6 mesecev) je povzročilo bistveno znižanje krvnega tlaka, znižanje števila rdečih krvnih celic (učinki, ki se pripisujejo farmakološki aktivnosti zdravila) in zvišanje sečnine (odpadnih snovi v krvi, ki vsebujejo dušik) v krvi.
English: Bottle for 35 ml
Slovenian: Škatla za 35 ml
English: Bottle for 30 ml
Slovenian: Plastenka za 30 ml
English: Carton for 35 ml
Slovenian: Plastenka za 35 ml
English: Semintra 10 mg/ml oral solution for cats telmisartan
Slovenian: Semintra 10 mg/ml peroralna raztopina za mačke telmisartan
English: Mild and transient gastrointestinal signs such as vomiting and diarrhoea associated with product administration have been observed commonly in a clinical study.
Slovenian: V klinični študiji so pogosto opazili blage in prehodne prebavne znake, kot sta bruhanje in driska, ki so povezani z dajanjem zdravila.
English: Administration of the product at overdose (up to 2.5 times the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN).
Slovenian: Dajanje prevelikega odmerka zdravila (do 2,5-kratnega priporočenega odmerka 6 mesecev) je povzročilo bistveno znižanje krvnega tlaka, zmanjšanje števila rdečih krvnih celic (učinki, ki jih je mogoče pripisati farmakološki aktivnosti zdravila) in povišanje sečnine v krvi.
English: Administration of the product at overdose (3 to 5 times of the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN).
Slovenian: Dajanje prevelikega odmerka zdravila (3 do 5-kratni priporočeni odmerek 6 mesecev) je povzročilo bistveno znižanje krvnega tlaka, znižanje števila rdečih krvnih celic (učinki, ki se pripisujejo farmakološki aktivnosti zdravila) in zvišanje sečnine v krvi.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega zaužitja takoj poiščite zdravniško pomoč in zdravniku pokažite navodila za uporabo ali ovojnino.
English: Semintra 4 mg/ml oral solution for cats Telmisartan
Slovenian: Semintra 4 mg/ml peroralna raztopina za mačke telmisartan
English: Semintra 10 mg/ml oral solution for cats
Slovenian: Semintra 10 mg/ml peroralna raztopina za mačke
English: Pack size of one bottle and one measuring syringe.
Slovenian: Velikost pakiranja je ena plastenka in ena merilna brizga.
English: The solution should be given using the measuring syringe provided in the package.
Slovenian: Raztopina se daje z merilno brizgo, ki je priložena pakiranju.
English: After administration of up to 2.5 times the initial recommended dose for 6 months to young adult healthy cats, adverse reactions observed were consistent with those mentioned in section 4.6.
Slovenian: Po dajanju do 2,5-kratnega priporočenega odmerka mladim odraslim zdravim mačkam 6 mesecev niso opazili nobenih neželenih učinkov, razen tistih, omenjenih v poglavju 4.6.
English: Semintra 4 mg/ml oral solution for cats
Slovenian: Semintra 4 mg/ml peroralna raztopina za mačke
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje sistemske hipertenzije pri mačkah.
English: PACKAGE LEAFLET: Semintra 10 mg/ml oral solution for cats
Slovenian: NAVODILO ZA UPORABO Semintra 10 mg/ml peroralna raztopina za mačke
English: PACKAGE LEAFLET: Semintra 4 mg/ml oral solution for cats
Slovenian: NAVODILO ZA UPORABO Semintra 4 mg/ml peroralna raztopina za mačke
English: Symptomatic treatment, e.g. fluid therapy, should be provided in case of any clinical signs of hypotension.
Slovenian: V primeru kakršnih koli kliničnih znakov hipotenzije je potrebno simptomatsko zdravljenje, npr. zdravljenje s tekočino.
English: Overdose (symptoms, emergency procedures, antidotes) After administration of up to 5 times the recommended dose for 6 months to young adult healthy cats, adverse reactions observed were consistent with those mentioned in section “Adverse reactions”.
Slovenian: Po dajanju do 5-kratnega priporočenega odmerka 6 mesecev mlajšim odraslim zdravim mačkam so bili neželeni učinki skladni s tistimi, ki so omenjeni v poglavju "Neželeni učinki".
English: Use entire content.
Slovenian: Uporabite celotno vsebino.
English: Please consult your doctor immediately.
Slovenian: Prosimo, da se takoj posvetujete s svojim zdravnikom.
English: Not known: frequency cannot be estimated from the available data
Slovenian: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
English: Repeat every 12 to 24 hours.
Slovenian: Odmerek je treba ponoviti vsakih 12 - 24 ur.
English: Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.
Slovenian: Podatki so bili zbrani v kliničnih preskušanjih pri 61 otrocih, mlajših od 6 let in neintervencijskih kliničnih preskušanjih pri otrocih vseh starosti.
English: Frequency of doses (hours)/ Duration of therapy (days)
Slovenian: pogostost odmerjanja (v urah)/ trajanje zdravljenja (v dnevih)
English: Make sure that no blood enters the syringe.
Slovenian: Zagotovite, da kri ne teče v brizgo.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Slovenian: V redkih primerih inhibitorji lahko nastanejo šele po prvih 100 dneh izpostavljenosti.
English: The condition may manifest itself as an insufficient clinical response.
Slovenian: To stanje se lahko kaže v obliki neustreznega kliničnega odziva.
English: However, please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru šoka je treba uvesti standardne ukrepe za zdravljenje šoka.
English: MedDRA Standard System Organ Class
Slovenian: MedDRA Standard Organski sistem
English: The required dose is determined using the following formulae:
Slovenian: Potrebni odmerek se izračuna po naslednji formuli:
English: • This medicine is intended for intravenous administration only and should be administered within 3 hours after reconstitution.
Slovenian: • To zdravilo je namenjeno samo za intravensko uporabo in ga je treba uporabiti v 3 urah po rekonstituciji.
English: • This medicine must not be mixed with other infusion solutions.
Slovenian: • Tega zdravila ne smete mešati z drugimi raztopinami za injiciranje.
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: • If you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
Slovenian: • če ste alergični na oktokog alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6 in v zadnjem odstavku poglavja 2),
English: Duration of treatment Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Slovenian: Trajanje zdravljenja Vaš zdravnik vam bo razložil, kako pogosto in v kakšnih presledkih morate uporabljati to zdravilo.
English: Do not increase your dose of medicine you use to control your bleeding without consulting your doctor.
Slovenian: Ne zvečajte odmerka tega zdravila, ki ga uporabljate za nadzor krvavitev, ne da bi se posvetovali s svojim zdravnikom.
English: The risk of developing inhibitors is correlated to the exposure to factor VIII and to genetic factors among others, this risk being highest within the first 20 exposure days.
Slovenian: Tveganje za nastanek inhibitorjev je v sorazmerju s časom izpostavljenosti faktorju VIII in med drugim tudi z genetskimi faktorji, pri čemer je tveganje največje v prvih dvajsetih dneh izpostavljenosti.
English: • If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.
Slovenian: • Če so vam povedali, da imate bolezen srca ali pri vas obstaja tveganje za bolezen srca, se posvetujte z zdravnikom ali s farmacevtom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 August 2000
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve: 4. avgust 2000
English: Draw air into an empty, sterile syringe.
Slovenian: Potegnite zrak v prazno sterilno brizgo.
English: Consequently, patients should be evaluated and monitored for cardiac risk factors.
Slovenian: Bolnike je treba oceniti in jih spremljati glede dejavnikov tveganja za srčnožilne bolezni.
English: Wash your hands thoroughly using soap and warm water.
Slovenian: S toplo vodo in milom si temeljito umijte roke.
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Slovenian: Pri bolnikih z visoko ravnijo inhibitorjev morda zdravljenje s faktorjem VIII ne bo učinkovito in bo treba upoštevati druge možnosti zdravljenja.
English: Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).
Slovenian: Z rokami segrejte neodprti viali na primerno temperaturo (ne več kot 37 °C).
English: In patients where immune tolerance was achieved the bleedings could be prevented or controlled with Helixate NexGen again, and the patients could continue with prophylactic treatment as maintenance therapy.
Slovenian: Pri bolnikih, pri katerih je bila imunska toleranca dosežena, je bilo mogoče krvavitev znova preprečiti ali nadzorovati z zdravilom Helixate NexGen, bolniki pa so lahko nadaljevali s profilaktičnim zdravljenjem kot vzdrževalnim zdravljenjem.
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 5 ml brizgo - dva alkoholna tampona za enkratno uporabo
English: Driving and using machines No effects on ability to drive or use machines have been observed.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Vpliva na sposobnost vožnje in upravljanja s stroji niso opazili.
English: If a further dose needs to be administered, use a new syringe with product reconstituted as described above.
Slovenian: Če je potreben dodaten odmerek zdravila, uporabite novo brizgo, zdravilo pa pripravite kot je opisano zgoraj.
English: • If you are allergic to mouse or hamster protein.
Slovenian: • če ste alergični na beljakovine miši ali hrčkov.
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN, ČE JE POTREBNO, POT(I) UPORABE
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: If no further dose is required, remove the venipuncture set and syringe.
Slovenian: Če dodaten odmerek ni potreben, odstranite pribor za punkcijo vene in brizgo.
English: The infusion rate should be calculated based on the clearance and the desired FVIII level.
Slovenian: Hitrost infundiranja je treba izračunati glede na očistek in želeno aktivnost FVIII.
English: Overall list of possible side effects:
Slovenian: Seznam možnih neželenih učinkov:
English: This medicine should be injected intravenously over several minutes.
Slovenian: To zdravilo je treba injicirati intravensko nekaj minut.
English: Inject the solution intravenously over several minutes, keeping an eye on the position of the needle.
Slovenian: Injicirajte raztopino v veno nekaj minut; pri tem ves čas pazite na položaj igle.
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): ............
English: The vial contains a dry white to slightly yellow powder or cake, as well as water for injections to be used to reconstitute the contents of the vial.
Slovenian: Viala vsebuje suh bel do rahlo rumen prašek ali pogačo, kot tudi vodo za injekcije, ki se uporablja za rekonstitucijo vsebine viale.
English: Example: for a 75 kg patient with a clearance of 3 ml/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%.
Slovenian: Primer: za bolnika težkega 75 kg z očistkom 3 ml/h/kg bi bila začetna hitrost infundiranja 3 i.e./h/kg, da bi dosegli 100 % aktivnost FVIII.
English: If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately.
Slovenian: Če se pojavijo alergijske ali anafilaktične reakcije je treba injiciranje takoj ustaviti.
English: • Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
Slovenian: • Takoj uporabite vaš naslednji odmerek in zdravljenje nadaljujte, kot vam je predpisal zdravnik.
English: Life threatening haemorrhages (such as intracranial bleed, throat bleed, severe abdominal bleed)
Slovenian: življenjsko nevarne krvavitve (npr. intrakranialna krvavitev, krvavitev v grlo, huda abdominalna krvavitev)
English: The safety and efficacy of Helixate NexGen in children of all ages have been established.
Slovenian: Varnost in učinkovitost zdravila Helixate NexGen pri otrocih vseh starosti sta bili dokazani.
English: Factor VIII inhibitors are antibodies in the blood which block the factor VIII you are using, and makes it less effective to prevent and control bleeding.
Slovenian: Inhibitorji faktorja VIII so protitelesa v krvi, ki zavirajo delovanje faktorja VIII, ki ga uporabljate, zato je faktor VIII pri preprečevanju in nadzoru krvavitev manj učinkovit.
English: Any unused solution must be discarded.
Slovenian: Neporabljeno raztopino je treba zavreči.
English: Each package of Helixate NexGen contains:
Slovenian: Vsako pakiranje zdravila Helixate NexGen vsebuje:
English: • If your bleeding is not being controlled with your usual dose of this medicine, consult your doctor immediately.
Slovenian: • Če se krvavitev po uporabi za vas predpisanega običajnega odmerka tega zdravila ne ustavi, se takoj posvetujte z vašim zdravnikom.
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem mililitru normalne človeške plazme.
English: Make sure that you only pull away the blister package and not the Mix2Vial set.
Slovenian: Pazite, da potegnete samo pretisni omot in ne kompleta Mix2Vial.
English: a) By bolus infusions Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Slovenian: a) z bolusnimi infuzijami Infuzijo je treba ponoviti vsakih 8 - 24 ur, dokler se rana ne zaceli; nato se nadaljuje z zdravljenjem vsaj še naslednjih 7 dni, tako da se vzdržuje aktivnost faktorja VIII na 30 - 60 % (i.e./dl).
English: This result is similar to the reported values for factor VIII derived from human plasma.
Slovenian: Rezultati so podobni kot pri faktorju VIII, ki je pridobljen iz humane plazme.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in all population groups except for the inhibitor formation.
Slovenian: Pediatrična populacija Pričakuje se, da so pogostnost, vrsta in resnost neželenega učinka pri otrocih enaki kot pri ostalih populacijah bolnikov, razen glede nastanka inhibitorjev.
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 proteina.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Slovenian: Za navodila za rekonstitucijo zdravila pred uporabo, glejte poglavje 6.6 in navodilo za uporabo.
English: Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom,
English: After the initial 24 hours of continuous infusion, the clearance should be recalculated every day using the steady state equation with the measured FVIII level and the rate of infusion using the following equation: clearance = infusion rate/actual FVIII level.
Slovenian: Po začetni 24-urni kontinuirani infuziji, je treba vsak dan preračunati očistek na podlagi izmerjene vrednosti FVIII in hitrosti infundiranja z uporabo naslednje enačbe: očistek = hitrost infundiranja/dejanska koncentracija FVIII.
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Slovenian: Aktivirani faktor VIII deluje kot kofaktor za aktivirani faktor IX in pospešuje pretvorbo faktorja X v aktivirani faktor X. Aktivirani faktor X
English: In patients with inhibitor titres above 10 BU or with high anamnestic response, the use of (activated) prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) preparations has to be considered.
Slovenian: Pri bolnikih s titrom inhibitorja nad 10 BE ali pozitivno anamnezo je treba razmisliti o uporabi (aktiviranega) koncentrata protrombinskega kompleksa (PCC) ali aktiviranega rekombinantnega faktorja VII (rFVIIa).
English: 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: Vaš zdravnik bo izračunal velikost in pogostost dajanja odmerka tega zdravila, ki ga potrebujete, da se pri vas doseže želena aktivnost faktorja VIII v krvi.
English: • mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)
Slovenian: • omotica • blaga hipotenzija (blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, kadar stojite)
English: Specific studies with repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with octocog alfa due to the immune response to heterologous proteins in all non-human mammalian species.
Slovenian: Specifične študije s ponavljajočimi se odmerki oktokoga alfa na sposobnost razmnoževanja, kronično toksičnost in kancerogeni potencial niso bile narejene zaradi pričakovanega imunskega odgovora vseh ne-humanih sesalcev na heterologne beljakovine.
English: The following table provides a guide for factor VIII minimum blood levels.
Slovenian: Naslednja tabela prikazuje navodila glede minimalnih vrednosti aktivnosti faktorja VIII v krvi.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Slovenian: Trombin pretvarja fibrinogen v fibrin, ki omogoča nastanek krvnega strdka.
English: If you have been told by your doctor that you have developed factor VIII inhibitors you may need to use a larger amount of this medicine to control bleeding.
Slovenian: Če vam je vaš zdravnik povedal, da so pri vas nastali inhibitorji faktorja VIII, boste morda za nadzor krvavitev potrebovali večji odmerek tega zdravila kot doslej.
English: Repeat infusion every 8 to 24 hours until threat is resolved
Slovenian: Odmerek je treba ponoviti vsakih 8 - 24 ur, dokler nevarnost za bolnika ni odpravljena.
English: - Known allergic reactions to mouse or hamster protein.
Slovenian: • Znane alergijske reakcije na beljakovine miši ali hrčkov.
English: The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the treatment of patients with haemophilia A. Your doctor may wish to carry out tests to monitor inhibitor development.
Slovenian: Nastanek nevtralizirajočih protiteles proti faktorju VIII (inhibitorji) je znan zaplet pri zdravljenju bolnikov s hemofilijo A. Vaš zdravnik se lahko odloči za preiskave za spremljanje nastanka inhibitorjev.
English: These treatments should be prescribed by doctors with experience in the care of patients with haemophilia A. Speak to your doctor if you would like further information on this.
Slovenian: Dodatno zdravljenje vam mora predpisati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo A. Posvetujte se z vašim zdravnikom, če v zvezi s tem potrebujete še kakršnekoli dodatne informacije.
English: For the calculation of the initial infusion rate, clearance can be obtained by performing a pre-surgery decay curve, or by starting from an average population value (3.0-3.5 ml/h/kg) and then adjust accordingly.
Slovenian: Za izračun začetne hitrosti infundiranja se lahko očistek določi iz krivulje razpada pred kirurškim posegom ali pa tako, da se izhaja iz povprečne populacijske vrednosti (3 - 3,5 ml/h/kg) in se jo nato ustrezno prilagodi.
English: Fertility There are no fertility data available.
Slovenian: Podatkov o vplivu na plodnost ni.
English: If these components cannot be used, please contact your doctor.
Slovenian: Če se sestavnih delov ne da uporabiti, se posvetujte s svojim zdravnikom.
English: Place the product vial on an even and firm surface.
Slovenian: Položite vialo z zdravilom na ravno in trdno površino.
English: Higher infusion rates may be required in conditions with accelerated clearance during major bleedings or extensive tissue damage during surgical interventions.
Slovenian: Večje hitrosti infundiranja so lahko potrebne pri večjih krvavitvah ali obsežni poškodbi tkiva med kirurškimi posegi, kadar je očistek zvečan.
English: You may have developed factor VIII inhibitors and your doctor may carry out tests to confirm this.
Slovenian: Možno je, da so pri vas nastali inhibitorji faktorja VIII in bo vaš zdravnik želel opraviti dodatne preiskave, ki bi to potrdile.
English: Method of administration Intravenous use.
Slovenian: Intravenska uporaba.
English: Helixate NexGen should be injected intravenously over several minutes.
Slovenian: Helixate NexGen je treba injicirati intravensko nekaj minut.
English: 100 % (1 IU/ml) 60 % (0.6 IU/ml) 40 % (0.4 IU/ml)
Slovenian: 100 % (1 i.e./ml) 3,0 60 % (0,6 i.e./ml) 1,8 40 % (0,4 i.e./ml) 1,2
English: Ensure product and solvent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry prior to opening the Mix2Vial package.
Slovenian: Prepričajte se, da sta zamaška viale z zdravilom in viale z vehiklom odstranjena in da so zaporke obrisane z aseptično raztopino, ki se mora posušiti pred odprtjem pakiranja Mix2Vial.