FrancophonIA/ELRC3.0 huggingface dataset:
English: PP (Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration preparation.
Slovenian: Za pripravo na dajanje uporabite PP (polipropilenske) ali PVC (polivinilkloridne)
English: Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg.
Slovenian: Oritavancin kaže linearno farmakokinetiko pri odmerkih do 1.200 mg.
English: • Swollen, red area of skin or underneath skin that feels hot and tender;
Slovenian: • otekel, rdeč predel kože ali pod kožo, ki je na otip vroč in občutljiv • kopičenje gnoja pod kožo
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja zdravila po rekonstituciji in redčenju glejte poglavje 6.3.
English: For patients who require aPTT monitoring within 120 hours of oritavancin dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered.
Slovenian: Za bolnike, pri katerih je treba spremljati aPTT v 120 urah po odmerjanju oritavancina, je treba razmisliti o drugih koagulacijskih testih, ki niso odvisni od fosfolipidov, kot je na primer (kromogeni) preizkus določanja aktivnosti faktorja Xa ali o alternativnem antikoagulantu, pri katerem ni treba spremljati aPTT.
English: - The active substance is oritavancin.
Slovenian: - Učinkovina je oritavancin.
English: • Inflammation surrounding a tendon (known as tenosynovitis);
Slovenian: • vnetje okoli tetive (tenosinovitis);
English: There are no or limited amount of data from the use of oritavancin in pregnant women.
Slovenian: Podatkov o uporabi oritavancina pri nosečnicah ni oziroma so omejeni.
English: Silica clot time (SCT)
Slovenian: Čas strjevanja s silicijem (SCT)
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na sposobnost razmnoževanja (glejte tudi poglavje 5.3).
English: • Bone infection caused by bacteria (known as osteomyelitis);
Slovenian: • kostna okužba, ki jo povzroča bakterija (osteomielitis)
English: In addition, medicinal products formulated at a basic or neutral pH may be incompatible with oritavancin (see section 6.6).
Slovenian: Poleg tega so lahko z oritavancinom nezdružljiva tudi zdravila, formulirana tako, da imajo bazično ali nevtralno vrednost pH (glejte poglavje 6.6).
English: Your doctor will monitor you in case this happens and treat you if necessary.
Slovenian: Vaš zdravnik vas bo spremljal, če se to zgodi, in vas po potrebi zdravil.
English: Liver function test abnormal (Alanine aminotransferase increased, Aspartate aminotransferase increased)
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogosti nenormalni testi delovanja jeter (povečana alanin aminotransferaza, povečana aspartata aminotransferaza)
English: What Orbactiv looks like and contents of the pack
Slovenian: Izgled zdravila Orbactiv in vsebina pakiranja
English: Orbactiv should not to be used in children or adolescents below the age of 18.
Slovenian: Otroci in mladostniki, stari manj kot 18 let, ne smejo uporabljati zdravila Orbactiv.
English: The pharmacokinetics of oritavancin were evaluated in a study of subjects with moderate hepatic impairment (Child-Pugh Class B, n=20) and compared with healthy subjects (n=20) matched for gender, age and weight.
Slovenian: Farmakokinetiko oritavancina so ovrednotili v študiji z osebami z zmerno okvaro jeter (razred B po Child-Pughu, n = 20) in jo primerjali z zdravimi prostovoljci (n = 20) ustreznega spola, starosti in višine.
English: Frequency of adverse reactions by system organ class
Slovenian: Pogostnost neželenih učinkov po organskih sistemih
English: • have or are suspected to have a painful collection of pus on your skin (abscess).
Slovenian: • imate ali sumite, da imate boleč ognojek na koži (absces).
English: Infusion related reactions
Slovenian: Reakcije, povezane z infundiranjem
English: Biochemistry changes associated with kidney function including decreases in urine-specific gravity and pH and slight increases in blood urea nitrogen and sporadic increases in creatinine were present in both rat and dog after treatment of two weeks.
Slovenian: Biokemične spremembe, povezane z delovanjem ledvic, vključno z znižanjem specifične teže urina,in pH urina ter blagim povišanjem dušika sečnine v krvi in sporadičnim povišanjem kreatinina so bile po
English: Intravenous infusions of Orbactiv can cause flushing of the upper body, hives, itching and/or rashes.
Slovenian: Intravensko infundiranje zdravila Orbactiv lahko povzroči redečico na zgornjem delu telesa, koprivnico, srbenje in/ali izpuščaj.
English: The primary adverse effect of oritavancin administration to rats and dogs was a dose related accumulation of eosinophilic granules in tissue macrophages including hepatocytes, renal cortical epithelial cells, adrenal cells and macrophages of the reticulo endothelial system.
Slovenian: Primarni neželeni učinek pri dajanju oritavancina podganam in psom je bilo od odmerka odvisno kopičenje eozinofilnih granulo v tkivnih makrofagih, vključno s hepatociti, ledvičnimi kortikalnimi epitelijskimi celicami, celicami nadledvične žleze in makrofagi retikuloendotelijskega sistema.
English: • Flushing of the face and upper body, hives, itching and/or rashes (red man syndrome) • Wheezing;
Slovenian: • rdečica na obrazu in zgornjem delu telesa, koprivnica, srbenje in/ali izpuščaj (sindrom rdečega moža)
English: Red man syndrome
Slovenian: periferni edem redki sindrom rdečega moža
English: • Withdraw 40 mL from each of the three reconstituted vials and add to D5W intravenous bag to bring the bag volume to 1,000 mL.
Slovenian: • Iz vsake od treh rekonstituiranih vial izvlecite 40 ml in vsebino vnesite v vrečo za intravensko infuzijo D5W, da dobite volumen vreče 1.000 ml.
English: While antibiotics, including Orbactiv, fight certain bacteria, they may not be active against other bacteria or fungi, which may, therefore, continue to grow.
Slovenian: Antibiotiki kot je Orbactiv uspešno zatirajo nekatere bakterije, proti drugim bakterijam ali glivam pa morda niso uspešni, zato lahko še naprej rastejo.
English: • High uric acid levels in the blood;
Slovenian: • visoke ravni sečne kisline v krvi
English: The powder must be reconstituted with water for injections and the resulting concentrate must be diluted in a glucose 5% intravenous infusion bag prior to use.
Slovenian: Prašek se rekonstituira z vodo za injekcije, dobljeni koncentrat pa se pred uporabo razredči v vreči za intravensko infuzijo s 5-% glukozo.
English: • Higher than normal levels of eosinophils, a type of white blood cell (eosinophilia);
Slovenian: • povišana raven eozinofilcev, vrste belih krvnih celic (eozinofilija) • nizek krvni sladkor
English: There is no known cross-resistance between oritavancin and non-glycopeptide classes of antibiotics.
Slovenian: Ni znane navzkrižne odpornosti med oritavancinom in razredom neglikopeptidnih antibiotikov.
English: Contains 400 mg oritavancin.
Slovenian: Vsebuje 400 mg oritavancina.
English: Additionally, in vitro human liver microsome studies indicated that oritavancin is not metabolized.
Slovenian: Tudi študije in vitro s človeškimi jetrnimi mikrosomi kažejo, da se oritavancin ne presnavlja.
English: Your doctor will treat you as necessary
Slovenian: Vaš zdravnik vas bo zdravil, kot je potrebno
English: Mannitol Phosphoric acid
Slovenian: manitol fosforna kislina
English: Powder for concentrate for solution for infusion 3 vials
Slovenian: prašek za koncentrat za raztopino za infundiranje 3 viale
English: This histopathological finding correlated with an enlargement and an increase in the weight of the spleen.
Slovenian: Histopatološki izsledki so korelirali s povečanjem in večjo težo vranice.
English: The exposure in rats at the no observed adverse effect level (NOAEL) was less to only slightly higher than the human exposure based on the AUC.
Slovenian: Izpostavljenost pri podganah na ravni brez vidnega neželenega učinka (NOAEL-no observed adverse effect level) je bila manjša ali le blago višja kot izpostavljenost pri ljudeh na podlagi AUC.
English: Adverse reactions for oritavancin from the pooled Phase 3 ABSSSI clinical trials with single dose oritavancin are listed by system organ class in the following table.
Slovenian: Neželeni učinki za oritavancin iz združenega programa kliničnih preskušanj ABSSSI faze 3 z enkratnim odmerjanjem oritavancina so našteti po organskih sistemih v naslednji preglednici.
English: Talk to your doctor or nurse before receiving Orbactiv if you:
Slovenian: Pred začetkom prejemanja zdravila Orbactiv se posvetujte z zdravnikom ali medicinsko sestro, če:
English: Oritavancin exhibits reduced in vitro activity against certain Gram-positive organisms of the genera Lactobacillus, Leuconostoc and Pediococcus that are intrinsically resistant to glycopeptides.
Slovenian: In vitro kaže oritavancin zmanjšano aktivnost proti nekaterim grampozitivnim organizmom iz rodov Lactobacillus, Leuconostoc in Pediococcus, ki so intrinzično odporni na glikopeptide.
English: Activated clotting time (ACT)
Slovenian: Aktivirani čas strjevanja (ACT)
English: Population pharmacokinetic analysis indicated that renal impairment had no clinically relevant effect on the exposure of oritavancin.
Slovenian: Analiza populacijske farmakokinetike kaže, da ledvična okvara nima klinično pomembnega vpliva na izpostavljenost oritavancinu.
English: • Each vial should be swirled gently to avoid foaming and ensure that all of the powder is completely reconstituted in solution.
Slovenian: • Vsako vialo je treba nežno zavrteti, da se tekočina ne peni in da se zagotovi popolna rekonstitucija praška v raztopini.
English: The exposure in rats at the NOAEL was less to only slightly higher than the human exposure based on the AUC.
Slovenian: Izpostavljenost pri podganah na ravni NOAEL je bila manjša ali le blago višja kot izpostavljenost pri ljudeh na podlagi AUC.
English: Orbactiv can only be used to treat infections caused by bacteria known as Gram positive bacteria.
Slovenian: Zdravilo Orbactiv se lahko uporablja le za zdravljenje okužb, ki jih povzročijo grampozitivne bakterije.
English: In the Phase 3 clinical trials, slightly more cases of newly emergent abscesses were reported in the oritavancin-treated arm than in the vancomycin-treated arm (4.6% vs 3.4%, respectively) (see section 4.8).
Slovenian: V kliničnih preskušanjih faze 3 so v kraku, zdravljenim z oritavancinom, poročali o nekoliko več primerih abscesov, ki so se pojavili na novo, kot v kraku, zdravljenim z vankomicinom (4,6 % v primerjavi s 3,4 %) (glejte poglavje 4.8).
English: Both the reconstituted solution and the diluted solution for infusion should be clear, colourless to pale yellow solution.
Slovenian: Tako rekonstituirana raztopina kot razredčena raztopina za infuzijo morata biti bistri, brezbarvni do svetlorumeni raztopini.
English: Up to 72 hours
Slovenian: Do 72 ur
English: No data are available on cross-reactivity between oritavancin and other glycopeptides, including vancomycin.
Slovenian: Podatki o navzkrižni reaktivnosti med oritavancinom in drugimi glikopeptidi, vključno z vankomicinom, niso na voljo.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje <in ravnanje z zdravilom>
English: Due to the possibility of cross-hypersensitivity, there should be careful monitoring of patients with any history of glycopeptide hypersensitivity during and after the infusion.
Slovenian: Zaradi možne navzkrižne preobčutljivosti morate bolnika s preobčutljivostjo na glikopeptid v anamnezi med infundiranjem in po njem skrbno spremljati.
English: Animal studies have revealed no evidence of impaired fertility due to oritavancin at the highest concentrations administered, however, there is no data on the effects of oritavancin on human fertility.
Slovenian: Plodnost Študije na živalih niso pokazale vpliva na sposobnost razmnoževanja zaradi oritavancina pri največjih dovoljenih koncentracijah, vendar pa ni podatkov o učinkih oritavancina na sposobnost razmnoževanja pri ljudeh.
English: Resistance to oritavancin was observed in vitro in vancomycin-resistant isolates of Staphylococcus aureus.
Slovenian: Odpornost na oritavancin in vitro so opazili pri izolatih Staphylococcus aureus, ki so odporni na vankomicin.
English: • Each vial should be swirled gently to avoid foaming and ensure that all Orbactiv powder is completely reconstituted in solution.
Slovenian: • Vsako vialo je treba nežno zavrteti, da se tekočina ne peni in da se zagotovi popolna rekonstitucija praška zdravila Orbactiv v raztopini.
English: No mass balance study has been conducted in humans.
Slovenian: Študij utežnega razmerja pri ljudeh niso izvajali.
English: Intravenous infusions of oritavancin can cause reactions that resemble “red man syndrome”, including flushing of the upper body, urticaria, pruritis and/or rash.
Slovenian: Intravenske infuzije oritavancina lahko povzročijo reakcije, podobne »sindromu rdečega moža«, vključno z rdečico na zgornjem delu telesa, urtikarijo, pruritusom in/ali izpuščajem.
English: Reconstitution: Aseptic technique should be used to reconstitute three Orbactiv 400 mg vials.
Slovenian: Rekonstitucija: Za rekonstitucijo treh vial zdravila Orbactiv 400 mg je treba uporabljati aseptično tehniko.
English: • 40 mL of water for injections (WFI) should be added using a sterile syringe to reconstitute each vial to provide a 10 mg/mL solution per vial.
Slovenian: • S sterilno injekcijsko brizgo je treba vsaki viali dodati 40 ml vode za injekcije, da dobimo raztopino s koncentracijo 10 mg/ml na vialo.
English: In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, oritavancin should be coadministered with appropriate antibacterial agent(s).
Slovenian: Pri mešanih okužbah, kjer obstaja sum na gramnegativne in/ali nekatere vrste anaerobnih bakterij, je treba oritavancin dajati skupaj z drugo ustrezno protibakterijsko učinkovino ali učinkovinami.
English: Table 1: Coagulation tests affected by oritavancin Assay
Slovenian: Preglednica 1: Testi koagulacije, na katere oritavancin vpliva Test
English: Up to 12 hours
Slovenian: Do 12 ur
English: Orbactiv may interfere with laboratory tests or self-test that measure how well your blood is clotting (INR) and may cause a false reading up to 12 hours after the infusion.
Slovenian: Zdravilo Orbactiv lahko vpliva na laboratorijske teste ali osebni diagnostični test, ki meri strjevanje krvi (INR), in povzroči lažne rezultate do 12 ur po infuziji.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of oritavancin (see section 4.8).
Slovenian: Zato je pri bolnikih, ki imajo po dajanju oritavancina drisko, pomembno pomisliti na to diagnozo (glejte poglavje 4.8).
English: 1,200 mg administered as a single dose by intravenous infusion over 3 hours.
Slovenian: 1.200 mg se daje kot enkratni odmerek v obliki 3-urne intravenske infuzije.
English: Hypersensitivity (see sections 4.3 and 4.4) , anaphylactic reaction
Slovenian: Bolezni imunskega sistema občasni preobčutljivost (glejte poglavji 4.3 in 4.4), anafilaktična reakcija neznana pogostnost anafilaktični šok
English: Clostridioides difficile-associated diarrhoea
Slovenian: Driska, povezana s Clostridioides difficile
English: Only glucose 5% intravenous bag (D5W) should be used for dilution.
Slovenian: Za redčenje je dovoljeno uporabljati le vreče za intravensko infuzijo s 5-% glukozo (D5W).
English: Oritavancin was found to be a nonspecific, weak inhibitor (CYP2C9 and CYP2C19) or a weak inducer (CYP3A4 and CYP2D6) of several CYP isoforms.
Slovenian: CYP2C19) ali šibak induktor (CYP3A4 in CYP2D6) več izooblik encima CYP.
English: Orbactiv should be prepared under aseptic techniques in a pharmacy.
Slovenian: Zdravilo Orbactiv je treba pripraviti v lekarni po aseptičnem postopku.
English: Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to oritavancin in vitro.
Slovenian: Klinična učinkovitost proti specifičnim patogenom Učinkovitost je bila dokazana v kliničnih študijah za naslednje patogene, ki so bili in vitro dovzetni za oritavancin.
English: Moderate, dose-related increases in liver enzymes (alanine transaminase and aspartate transaminase) were observed in rats and dogs and were shown to be reversible upon cessation of treatment.
Slovenian: Pri podganah in psih so opazili zmerno, od odmerka odvisno povišanje vrednosti jetrnih encimov (alanin transaminaze in aspartat transaminaze), ki je bilo po prenehanju dajanja reverzibilno.
English: This yields a concentration of 1.2 mg/mL of oritavancin.
Slovenian: Tako dobite koncentracijo oritavancina 1,2 mg/ml.
English: • Heart racing or beating fast;
Slovenian: • razbijanje ali hitro utripanje srca
English: Oritavancin is a type of antibiotic (a lipoglycopeptide antibiotic) that can kill or stop the growth of certain bacteria.
Slovenian: (lipoglikopeptidni antibiotik), ki lahko ubije nekatere bakterije ali ustavi njihovo rast.
English: There were no relevant changes in pharmacokinetics of oritavancin in subjects with moderate hepatic impairment.
Slovenian: Pomembnih sprememb v farmakokinetiki oritavancina pri osebah z zmerno jetrno okvaro ni bilo.
English: • Increased blood bilirubin levels ;
Slovenian: • zvišane ravni bilirubina v krvi
English: These effects result from oritavancin binding to and preventing the action of the phospholipid reagents which activate coagulation in commonly used laboratory coagulation tests.
Slovenian: Ti učinki so posledica vezave oritavancina na fosfolipidne reagente, ki aktivirajo koagulacijo pri pogosto uporabljenih laboratorijskih testih koagulacije, in preprečitve njihovega delovanja.
English: The appearance of the eosinophilic granules did not occur following single dose administration and did not significantly affect innate macrophage function in vitro at intracellular levels anticipated from a single 1,200 mg dose.
Slovenian: Eozinofilne granule se niso pojavile po dajanju enega odmerka in in vitro niso bistveno vplivale na naravno delovanje makrofagov pri predvidenih znotrajceličnih ravneh od enkratnega odmerka
English: The recommended dose for Orbactiv is one single infusion of 1,200 mg administered into a vein over 3 hours.
Slovenian: Priporočeni odmerek zdravila Orbactiv je ena 3-urna infuzija 1.200 mg v veno.
English: Orbactiv may interfere with laboratory tests that measure how well your blood is clotting and may cause a false reading.
Slovenian: Zdravilo Orbactiv lahko vpliva na laboratorijske teste za merjenje strjevanja krvi in povzroči napačne odčitke.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/<in na spletni strani {ime agencije v državi članici (povezava)}>.
English: No metabolites were observed in plasma or bile from oritavancin treated dogs and rats, respectively.
Slovenian: V plazmi ali žolču psov in podgan, ki so jim dajali oritavancin, niso opazili presnovkov.
English: • To avoid excessive foaming, it is recommended that WFI should be added carefully, along the walls of the vials.
Slovenian: • Da se tekočina na peni preveč, je treba vodo za injekcije dodajati previdno vzdolž sten viale.
English: Dilute Russell's viper venom time (DRVVT)
Slovenian: Russellovega gada (DRVVT)
English: Parenteral medicinal products should be inspected visually for particulate matter after reconstitution.
Slovenian: Parenteralna zdravila je treba po rekonstituciji in pred uporabo vizualno pregledati, ali vsebujejo delce.
English: No dosage adjustment is needed in patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Prilagajanje odmerka pri bolnikih z blago ali zmerno okvaro ledvic ni potrebno (glejte poglavje 5.2).
English: If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2-8°C for Orbactiv diluted in glucose 5% intravenous infusion bag, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Običajno naj bi čas shranjevanja ne bil daljši od 12 ur pri 25 ºC in 24 ur pri 2 do 8 ºC za zdravilo Orbactiv, razredčeno v vreči za intravensko infuzijo z glukozo, razen če je rekonstitucija ali redčenje potekalo pod nadziranimi in validiranimi aseptičnimi pogoji.
English: Up to 24 hours
Slovenian: Do 24 ur
English: In humans, less than 1% to 5% of the dose was recovered as parent drug in faeces and urine respectively after 2 weeks of collection indicating that oritavancin is slowly excreted unchanged.
Slovenian: 1 % izhodiščne učinkovine v blatu in manj kot 5 % v urinu, kar kaže, da se oritavancin počasi izloča v nespremenjeni obliki.
English: Based on population PK analysis, the population mean total volume of distribution is estimated to be approximately 87.6 L, indicating oritavancin is extensively distributed into the tissues.
Slovenian: 87,6 l, kar kaže, da se oritavancin obsežno porazdeljuje po tkivih.
English: The pharmacokinetics of oritavancin was examined in the single dose Phase 3 ABSSSI studies in patients with normal renal function, CrCL ≥90 mL/min (n=213), mild renal impairment, CrCL 60-89 mL/min (n=59), moderate renal impairment, CrCL 30-59 mL/min (n=22), and severe renal impairment CrCL <30 mL/min (n=3).
Slovenian: blago ledvično okvaro, CrCL 60-89 ml/min (n = 59), zmerno ledvično okvaro, CrCL 30-59 ml/min
English: The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated.
Slovenian: Farmakokinetike oritavancina pri bolnikih s hudo okvaro ledvic niso ovrednotili.
English: Exposures (AUC0-24) of oritavancin in skin blister fluid were 20% of those in plasma after a single 800 mg dose in healthy subjects.
Slovenian: Izpostavljenosti (AUC0-24) oritavancinu v tekočini kožnih mehurjev so bile enake 20 %
English: Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of ill effects.
Slovenian: Če dobite večji odmerek zdravila Orbactiv, kot bi smeli Vaš zdravnik se bo odločil o tem, kako vas bo zdravil, vključno z ustavitvijo zdravljenja in spremljanje bolezenskih znakov.
English: patients is 138 (23) μg/ml and 2,800 (28.6) μg•h/mL respectively.
Slovenian: Pri bolnikih, ki so prejeli en odmerek 1.200 mg zaradi ABSSSI, je povprečna (CV %) največja koncentracija oritavancina (Cmax) 138 (23) μg/ml, AUC0-∞ pa 2.800 (28,6) μg•h/ml.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Urticaria, rash, pruritis
Slovenian: ekstravazacija, induracija, pruritis, izpuščaj,
English: The pharmacokinetics of oritavancin in patients with severe hepatic impairment has not been studied.
Slovenian: Farmakokinetike oritavancina pri bolnikih s hudo okvaro jeter niso preučili.
English: Single-use 50 ml Type 1 glass vials with rubber stoppers and aluminium flip off cap. 3 individual vials are packaged in a carton.
Slovenian: 50 ml steklena viala iz stekla tipa 1 za enkratno uporabo z gumijastim zamaškom in aluminijasto zaporko na poteg.
English: After reconstitution, 1 ml of the solution contains 10 mg oritavancin.
Slovenian: Po rekonstituciji vsebuje 1 ml raztopine 10 mg oritavancina.