FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on the nature and severity of the reaction, your doctor may decide whether to slow or stop the infusion completely and start the appropriate treatment.
Slovenian: Odvisno od narave in resnosti reakcije se lahko zdravnik odloči za upočasnitev ali popolno ustavitev infundiranja in uvedbo ustreznega zdravljenja.
English: Prime the chamber by squeezing the drip chamber until Respreeza has filled the chamber half-way.
Slovenian: Napolnite komoro, tako da stiskate kapalno komoro, dokler zdravilo Respreeza komore ne napolni do polovice.
English: No animal fertility studies have been conducted with Respreeza and its effect on human fertility has not been established in controlled clinical trials.
Slovenian: Študij razmnoževanja pri živalih z zdravilom Respreeza niso opravili, zato učinek na plodnost pri ljudeh ni bil ugotovljen v nadzorovanih kliničnih preskušanjih.
English: Make sure that the roller clamp on the administration set is closed.
Slovenian: Prepričajte se, da je stišček na pripomočku za infundiranje zaprt.
English: Paediatric Population Safety and effectiveness in the paediatric population have not been established.
Slovenian: Varnost in učinkovitost zdravila Respreeza pri pediatrični populaciji nista bili dokazani.
English: You may be allergic to human alpha1-proteinase inhibitor even if you have previously received human alpha1-proteinase inhibitors and had tolerated them well.
Slovenian: Morda ste alergični na humani zaviralec alfa1-proteinaze, tudi če ste pred tem že prejemali humani zaviralec alfa1-proteinaze in ste ga dobro prenašali.
English: Any unused medicinal product or waste material should be disposed as instructed by your doctor or healthcare professional.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z navodili zdravnika ali zdravstvenega delavca.
English: Discard the water for injections vial with the entire Mix2Vial set.
Slovenian: Zavrzite vialo z vodo za injekcije s celotnim kompletom Mix2Vial.
English: However, despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Slovenian: Vendar pa kljub tem ukrepom pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni mogoče povsem izključiti prenosa okužb.
English: Normal healthy individuals produce sufficient alpha1-proteinase inhibitor to control the NE produced by activated neutrophils and are thus able to prevent inappropriate proteolysis of lung tissue by NE.
Slovenian: Pri normalnih zdravih posameznikih nastaja dovolj zaviralca alfa1proteinaze za nadzor NE, ki ga tvorijo aktivirani nevtrofilci, zato lahko preprečijo neustrezno proteolizo pljučnega tkiva zaradi NE.
English: It is unknown whether Respreeza / metabolites are excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Respreeza/njegovi presnovki izločajo v materino mleko.
English: The RAPID extension study demonstrated that the reduced rate in lung density decline was maintained for subjects continuously treated with Respreeza for 4 years (see Figure 1).
Slovenian: Podaljšek študije RAPID je pokazal, da se je počasnejše zmanjševanje pljučne gostote pri preiskovancih, ki so se 4 leta neprekinjeno zdravili z zdravilom Respreeza, ohranilo (glejte sliko 1).
English: The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in specific clinical trials.
Slovenian: Varnost in učinkovitost zdravila Respreeza pri starejših bolnikih (starih 65 let ali več) nista bili dokazani v specifičnih kliničnih preskušanjih.
English: Since human alpha1-proteinase inhibitor is a protein and a physiological constituent of human blood, it is not expected to present carcinogenic, genotoxic, or teratogenic effects.
Slovenian: Ker je humani zaviralec alfa1proteinaze beljakovina in fiziološka sestavina krvi pri človeku, se kancerogeni, genotoksični ali teratogeni učinki ne pričakujejo.
English: Dizziness may occur following the administration of Respreeza (see section 4.8).
Slovenian: Po dajanju zdravila Respreeza se lahko pojavi omotica (glejte poglavje 4.8).
English: This medicine contains the active substance human alpha1-proteinase inhibitor, which is a normal component of the blood and is found in the lung.
Slovenian: To zdravilo vsebuje učinkovino humani zaviralec alfa1-proteinaze, ki je normalna sestavina krvi in se najde v pljučih.
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Slovenian: Previdno odstranite pretisni omot s kompleta Mix2Vial, tako da jo primete za obod in potegnete navpično navzgor.
English: Excipients with known effect Respreeza contains approximately 1.9 mg sodium per ml of reconstituted solution (81 mmol/l).
Slovenian: Pomožne snovi z znanim učinkom Zdravilo Respreeza vsebuje približno 1,9 mg natrija na ml rekonstituirane raztopine (81 mmol/l).
English: Elevate the administration container (if intravenous bag, hang on an intravenous pole).
Slovenian: Dvignite vsebnik za apliciranje (v primeru intravenske vrečke jo obesite na stojalo za infuzijo).
English: The safety and efficacy of Respreeza in the paediatric population (below 18 years) have not been established.
Slovenian: Varnost in učinkovitost zdravila Respreeza pri pediatrični populaciji (stari do 18 let) nista bili dokazani.
English: What Respreeza is and what it is used for
Slovenian: Kaj je zdravilo Respreeza in za kaj ga uporabljamo
English: Human alpha1-proteinase inhibitor is understood to be the primary anti-protease in the lower respiratory tract, where it inhibits neutrophil elastase (NE).
Slovenian: Predvideva se, da je humani zaviralec alfa1-proteinaze primarna proti-proteaza v spodnjih dihalih, kjer zavira nevtrofilno elastazo (NE).
English: This medicine is used in adults with known severe alpha1-proteinase inhibitor deficiency (an inherited condition also called alpha1 antitrypsin deficiency) who have developed a lung condition called emphysema.
Slovenian: To zdravilo se uporablja pri odraslih z znanim hudim pomanjkanjem zaviralca alfa1-proteinaze (podedovana bolezen, ki se imenuje tudi pomanjkanje alfa1 antitripsina), pri katerih se je razvila bolezen pljuč, imenovana emfizem.
English: Hypersensitivity reactions may occur, including in patients who have tolerated previous treatment with human alpha1-proteinase inhibitor.
Slovenian: Pojavijo se lahko preobčutljivostne reakcije, tudi pri bolnikih, ki so predhodno zdravljenje s humanimi zaviralci alfa1-proteinaze prenašali.
English: The recommended dose is 60 mg per kg of body weight and should be administered once per week.
Slovenian: Priporočeni odmerek je 60 mg na kg telesne mase in se daje enkrat na teden.
English: One vial contains approximately 1,000 mg, 4,000 mg or 5,000 mg of alpha1-proteinase inhibitor.
Slovenian: Ena viala vsebuje približno 1.000 mg, 4.000 mg ali 5.000 mg zaviralca alfa1-proteinaze.
English: The mean trough serum alpha1-proteinase inhibitor levels at steady state (Weeks 7-11) were maintained above 11 M.
Slovenian: Povprečne najnižje ravni zaviralca alfa1proteinaze v serumu v stanju dinamičnega ravnovesja (tedni 7 do 11) so se ohranile nad 11 M.
English: • With the other hand tightly grasp the water for injections vial and the blue part of the Mix2Vial set.
Slovenian: • Z drugo roko močno primite vialo z vodo za injekcije in modri del kompleta Mix2Vial.
English: Such side effects may occur even if you previously received human alpha1-proteinase inhibitors and had tolerated them well.
Slovenian: Taki neželeni učinki se lahko pojavijo celo, če ste predhodno že prejemali humani zaviralec alfa1proteinaze in ste ga dobro prenašali.
English: Respreeza should only be administered intravenously by infusion after reconstitution.
Slovenian: Zdravilo Respreeza se lahko daje le v obliki intravenske infuzije po rekonstituciji.
English: The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in clinical trials.
Slovenian: Varnost in učinkovitost zdravila Respreeza pri starejših bolnikih (starih 65 let ali več) nista bili dokazani v kliničnih preskušanjih.
English: How to use Respreeza
Slovenian: Kako uporabljati zdravilo Respreeza
English: CSL Behring GmbH, 35041 Marburg, Germany
Slovenian: CSL Behring GmbH, 35041 Marburg, Nemčija
English: Your doctor will inform you about signs of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands, face, or mouth) (see also section 4).
Slovenian: Zdravnik vas bo obvestil o znakih alergijske reakcije (na primer mrzlica, vročinski oblivi, hitrejši srčni utrip, padec krvnega tlaka, vrtoglavica, izpuščaj, koprivnica, srbenje, težave z dihanjem ali požiranjem ter otekanje rok, obraza ali ust) (glejte tudi poglavje 4).
English: The model predicted mean steady-state concentration was 21.8 µM after a 60 mg /kg bw / week dose.
Slovenian: Z modelom je bila napovedana povprečna koncentracija v stanju dinamičnega ravnovesja 21,8 µM po odmerku 60 mg/kg telesne mase/teden.
English: Use aseptic technique to transfer the reconstituted solutions into the administration container (e.g., empty intravenous bag or glass bottle; (not supplied) via a commercially available intravenous fluid tubing transfer set (not supplied)).
Slovenian: Z aseptično tehniko prenesite rekonstituirano raztopino v vsebnik za apliciranje (npr. v prazno intravensko vrečo ali steklenico (ni priloženo); z intravenskim cevnim setom za prenos, ki ga kupite (ni priloženo)).
English: Do not remove the Mix2Vial set from the blister package.
Slovenian: Ne odstranite kompleta Mix2Vial iz pretisnega omota.
English: First infusions should be administered under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Slovenian: Prve infuzije je treba dati pod nadzorom zdravstvenega delavca z izkušnjami v zdravljenju pomanjkanja zaviralca alfa1-proteinaze.
English: After reconstitution, the solution should be used immediately.
Slovenian: Pripravljeno raztopino je treba uporabiti takoj.
English: After it has been reconstituted with water for injections, the solution should be clear, colourless to slightly yellow and free from visible particles.
Slovenian: Po rekonstituciji z vodo za injekcije mora biti raztopina bistra, brezbarvna do rahlo rumenkasta in brez vidnih delcev.
English: Open the Mix2Vial set by peeling off the lid (Figure 1).
Slovenian: Odprite komplet Mix2Vial tako, da odlepite pokrov (slika 1).
English: Human alpha1-proteinase inhibitor is a normal constituent of human blood.
Slovenian: Humani zaviralec alfa1-proteinaze je normalna sestavina človeške krvi.
English: This analysis revealed an inverse linear relationship between trough serum alpha1-proteinase inhibitor levels and the annual decline in lung density as measured by volume adjusted CT scans for subjects receiving 60 mg / kg bw intravenous dose of Respreeza.
Slovenian: Ta analiza je pokazala inverzno linearno razmerje med najnižjimi ravnmi zaviralca alfa1-proteinaze v serumu in letnim upadom pljučne gostote, izmerjene s slikami CT, prilagojenimi za volumen, za osebe, ki so prejemale intravenski odmerek zdravila Respreeza 60 mg/kg telesne mase.
English: The total protein content is approximately 5,500 mg per vial.
Slovenian: Skupna vsebnost beljakovine je približno 5.500 mg na vialo.
English: Remove the plastic flip-top cap from the water for injections vial.
Slovenian: Odstranite plastično zunanjo zaščitno zaporko z viale z vodo za injekcije.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema bolečine v bezgavki
English: System Organ Class (SOC)
Slovenian: Organski sistem (OS)
English: Place the water for injections vial on an even, clean surface and hold the vial tight.
Slovenian: Postavite vialo z vodo za injekcije na ravno, čisto podlago in jo trdno držite.
English: • if you are allergic to human alpha1-proteinase inhibitor or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na humani zaviralec alfa1-proteinaze ali katero koli sestavino tega zdravila
English: After reconstitution, Respreeza is given by infusion into a vein.
Slovenian: Po rekonstituciji se zdravilo Respreeza infundira v žilo.
English: The mean (Standard Deviation) of the steady state trough serum alpha1-proteinase inhibitor level for Respreeza-treated subjects was 17.7 M (2.5).
Slovenian: Povprečna (standardni odklon) najnižja raven zaviralca alfa1-proteinaze v serumu v stanju dinamičnega ravnovesja pri osebah, zdravljenih z zdravilom Respreeza, je bila 17,7 M (2,5).
English: Very rarely (may affect up to 1 in 10,000 people) Decreased sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (hypoaesthesia), excessive sweating (hyperhidrosis), itching, chest pain, chills, fever (pyrexia).
Slovenian: Zelo redki (pojavijo se lahko največ pri 1 od 10.000 bolnikov) zmanjšan občutek na dotik, kot je pekoč občutek, mravljinčenje ali občutek otrplosti v dlaneh, rokah, nogah ali stopalih (hipestezija), pretirano znojenje (hiperhidroza), srbenje, bolečine v prsnem košu, mrzlica, zvišana telesna temperatura (pireksija).
English: Do NOT take Respreeza
Slovenian: NE uporabljajte zdravila Respreeza
English: There are no data concerning the effect on fertility but as alpha1-proteinase inhibitor is a normal component of human blood, no adverse effects on fertility are expected if you use Respreeza at the recommended dose.
Slovenian: Ni podatkov o učinku na plodnost, vendar je zaviralec alfa1-proteinaze normalna sestavina človeške krvi, zato neželenih učinkov na plodnost pri uporabi priporočenega odmerka zdravila Respreeza ni za pričakovati.
English: Post authorisation efficacy study (PAES): A randomized, long-term PAES has been agreed to study the dose-relationship if the higher API levels achieved in the blood might influence the rate of lung density decline and whether that would support an increased dose of 120mg/kg the MAH should conduct and submit the results of a randomized, long term, efficacy study conducted according to an agreed protocol.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Dogovorjena je bila randomizirana, dolgotrajna študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom za preučitev razmerja odmerka, če lahko višje ravniučinkovin, dosežene v krvi, vplivajo na stopnjo upada pljučne gostote, in ali to podpira večji odmerek 120 mg/kg.
English: Place the Respreeza vial on an even and firm surface.
Slovenian: Vialo z zdravilom Respreeza postavite na ravno in trdno podlago.
English: The total protein content is approximately 4,400 mg per vial.
Slovenian: Skupna vsebnost beljakovine je približno 4.400 mg na vialo.
English: Presentations
Slovenian: Opis
English: Tell your doctor or healthcare professional immediately if you notice any sign of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands,
Slovenian: Zdravniku ali zdravstvenemu delavcu takoj povejte, če med apliciranjem zdravila Respreeza opazite kakršne koli znake alergijske reakcije (na primer mrzlico, vročinske oblive, hitrejše bitje srca, padec krvnega tlaka, občutek vrtoglavosti, izpuščaj, koprivnico, srbenje, težave z dihanjem ali požiranjem ter oteklost rok, obraza ali ust).
English: Using this medicine regularly increases the blood and lung levels of alpha1-proteinase inhibitor, thus slowing the progression of emphysema.
Slovenian: Redna uporaba tega zdravila poveča raven zaviralca alfa1-proteinaze v krvi in pljučih, kar upočasni napredovanje emfizema.
English: Non-clinical data reveal no special risk for humans based on safety pharmacology and short term toxicity studies.
Slovenian: Predklinični podatki na osnovi študij farmakološke varnosti in kratkotrajnih študij toksičnosti ne kažejo posebnega tveganja za človeka.
English: Epithelial lining fluid measurements (ELF) of alpha1-proteinase inhibitor levels showed a consistent increase following treatment.
Slovenian: Izmerjene vrednosti zaviralca alfa1-proteinaze v epitelijski tekočini so pokazale konsistentno povečanje po zdravljenju.
English: The total protein content is approximately 1,100 mg per vial.
Slovenian: Skupna vsebnost beljakovine je približno 1.100 mg na vialo.
English: Close the roller clamp.
Slovenian: Stišček zaprite.
English: This infusion rate may be adjusted, based upon patient tolerability.
Slovenian: Hitrost infundiranja se lahko prilagodi glede na to, kako bolnik prenaša zdravilo.
English: The active substance is alpha1-proteinase inhibitor.
Slovenian: Učinkovina je zaviralec alfa1-proteinaze.
English: Commonly (may affect up to 1 in 10 people) Dizziness, headache, shortness of breath (dyspnea), nausea.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) omotica, glavobol, zasoplost (dispneja), slabost (navzea).
English: Urticaria, rash (including exfoliative and generalized)
Slovenian: Bolezni kože in podkožja urtikarija, izpuščaj (vključno z eksfoliativnim in generaliziranim)
English: Wipe the rubber stopper of the water for injections vial with antiseptic solution and allow it to dry.
Slovenian: Gumijasti zamašek viale z vodo za injekcije obrišite z antiseptično raztopino in počakajte, da se posuši.
English: The solvent is a clear and colourless solution.
Slovenian: Vehikel je prozorna in brezbarvna raztopina.
English: Chest pain, chills, pyrexia
Slovenian: bolečine v prsnem košu, mrzlica, pireksija
English: • The reconstituted solution should be clear, colorless to slightly yellow, and free from visible particles.
Slovenian: • Rekonstituirana raztopina mora biti bistra, brezbarvna do rahlo rumenkasta in brez vidnih delcev.
English: SOLVENT VIAL
Slovenian: VIALA Z VEHIKLOM
English: Excipients : Sodium chloride, sodium dihydrogen phosphate monohydrate, mannitol.
Slovenian: Pomožne snovi: natrijev klorid, natrijev dihidrogenfosfat monohidrat, manitol.
English: Respreeza contains approximately 1.9 mg (<1 mmol) sodium per ml of reconstituted solution.
Slovenian: Zdravilo Respreeza vsebuje približno 1,9 mg (< 1 mmol) natrija na ml rekonstituirane raztopine.
English: Make sure that you only pull away the blister package and not the Mix2Vial set (Figure 3).
Slovenian: Glejte, da odstranite le pretisni omot in ne tudi kompleta Mix2Vial.
English: The solution should be clear, colourless to slightly yellow, and free from visible particles.
Slovenian: Raztopina mora biti bistra, brezbarvna do rahlo rumenkasta in brez vidnih delcev.
English: What Respreeza is used for
Slovenian: Za kaj se zdravilo Respreeza uporablja
English: The recommended dose of 60 mg per kg of body weight will take approximately 15 minutes to infuse.
Slovenian: Infundiranje priporočenega odmerka 60 mg na kg telesne mase traja približno 15 minut.
English: • 1°solvent vial of 95 ml water for injections
Slovenian: • 1 viala z vehiklom s 95 ml vode za injekcije
English: Asthenia, infusion-site reactions (including infusion site hematoma)
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija, reakcije na mestu infundiranja (vključno s hematomom na mestu infundiranja)
English: Attach the administration set to the administration container.
Slovenian: Pripomoček za infundiranje priključite na vsebnik za apliciranje.
English: • 1°solvent vial of 76 ml water for injections
Slovenian: • 1 viala z vehiklom s 76 ml vode za injekcije
English: This medicine contains 1.9mg sodium perml of reconstituted solution.
Slovenian: To zdravilo vsebuje približno 1,9mg natrija na ml rekonstituirane raztopine.
English: The reconstituted solution must be administered using an intravenous administration set (not supplied).
Slovenian: Rekonstituirano raztopino morate aplicirati z uporabo kompleta za intravensko infundiranje (ni priloženo).
English: Since alpha1-proteinase inhibitor is a normal component of human blood, recommended dose of this medicine is not expected to cause harm to the developing foetus.
Slovenian: Ker je zaviralec alfa1-proteinaze normalna sestavina človeške krvi, ni za pričakovati, da bi priporočeni odmerek tega zdravila škodoval razvoju zarodka.
English: Sodium dihydrogen phosphate monohydrate Mannitol
Slovenian: Prašek: natrijev klorid natrijev dihidrogenfosfat monohidrat manitol
English: Respreeza 1,000 mg powder and solvent for solution for infusion Respreeza 4,000 mg powder and solvent for solution for infusion Respreeza 5,000 mg powder and solvent for solution for infusion
Slovenian: Respreeza 1.000 mg prašek in vehikel za raztopino za infundiranje Respreeza 4.000 mg prašek in vehikel za raztopino za infundiranje Respreeza 5.000 mg prašek in vehikel za raztopino za infundiranje
English: Take the Mix2Vial set together with the blister package and vertically pierce the water for injections vial with the blue tip of the Mix2Vial set (Figure 2).
Slovenian: Vzemite komplet Mix2Vial skupaj s pretisnim omotom in z modro konico kompleta Mix2Vial navpično prebodite vialo z vodo za injekcije (slika 2).
English: Altered sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (paraesthesia), flushing, hives (urticaria), scaly rash and rash all over the body, physical weakness (asthenia), infusion-site reactions (such as burning, stinging, pain, swelling or redness at the infusion site (hematoma)).
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) spremenjen občutek na dotik, kot je pekoč občutek, mravljinčenje ali občutek otrplosti v dlaneh, rokah, nogah ali stopalih (parestezija), vročinski oblivi, koprivnica (urtikarija), luskast izpuščaj in izpuščaj po vsem telesu, fizična oslabelost (astenija), reakcije na mestu infundiranja (kot je ščemenje, zbadanje, bolečina, oteklost ali rdečina na mestu infundiranja (hematom)).
English: CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
Slovenian: CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Nemčija
English: ELF levels of antigenic alpha1-proteinase inhibitor and alpha1-proteinase inhibitor: NE complexes increased from baseline.
Slovenian: Ravni antigenskega zaviralca alfa1-proteinaze in zaviralca alfa1-proteinaze v epitelijski tekočini: Povečanje kompleksov NE od izhodišča.
English: The administration of Respreeza increases and maintains serum levels and lung epithelial lining fluid (ELF) levels of alpha1-proteinase inhibitor leading to a slowdown of the progression of emphysema.
Slovenian: Dajanje zdravila Respreeza poveča in ohranja ravni zaviralca alfa1-proteinaze v serumu in epitelijski tekočini pljuč, kar upočasni napredovanje emfizema.
English: Inspect visually the reconstituted solution.
Slovenian: Rekonstituirano raztopino preglejte s prostim očesom.
English: • 1°single-use powder vial
Slovenian: • 1 viala s praškom za enkratno uporabo
English: • 1°transfer set 20/20 (Mix2Vial set) for reconstitution
Slovenian: •1kompletza prenos 20/20(komplet Mix2Vial) za rekonstitucijo
English: CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany
Slovenian: CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Nemčija
English: - If you get any side effects, talk to your doctor or healthcare professional.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali zdravstvenim delavcem.
English: Wipe the rubber stopper of the Respreeza vial with antiseptic solution and allow it to dry.
Slovenian: Gumijasti zamašek viale zdravila Respreeza obrišite z antiseptično raztopino in počakajte, da se posuši.
English: Invert the water for injections vial with the Mix2Vial set attached and vertically pierce the Respreeza vial with the clear tip of the Mix2Vial set (Figure 4).
Slovenian: Obrnite vialo z vodo za injekcije, na katero je pritrjen komplet Mix2Vial, in navpično prebodite vialo z zdravilom Respreeza s prozorno konico kompleta Mix2Vial (slika 4).
English: • 1°solvent vial of 20 ml water for injections
Slovenian: • 1 viala z vehiklom z 20 ml vode za injekcije